Can Clinical and Surgical Parameters Be Combined to Predict How Long It Will Take a Tibia Fracture to Heal? A Prospective Multicentre Observational Study: The FRACTING Study

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Leo Massari

2018-01-01

Full Text Available Background. Healing of tibia fractures occurs over a wide time range of months, with a number of risk factors contributing to prolonged healing. In this prospective, multicentre, observational study, we investigated the capability of FRACTING (tibia FRACTure prediction healING days score, calculated soon after tibia fracture treatment, to predict healing time. Methods. The study included 363 patients. Information on patient health, fracture morphology, and surgical treatment adopted were combined to calculate the FRACTING score. Fractures were considered healed when the patient was able to fully weight-bear without pain. Results. 319 fractures (88% healed within 12 months from treatment. Forty-four fractures healed after 12 months or underwent a second surgery. FRACTING score positively correlated with days to healing: r=0.63 (p<0.0001. Average score value was 7.3 ± 2.5; ROC analysis showed strong reliability of the score in separating patients healing before versus after 6 months: AUC = 0.823. Conclusions. This study shows that the FRACTING score can be employed both to predict months needed for fracture healing and to identify immediately after treatment patients at risk of prolonged healing. In patients with high score values, new pharmacological and nonpharmacological treatments to enhance osteogenesis could be tested selectively, which may finally result in reduced disability time and health cost savings.

Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study

DEFF Research Database (Denmark)

Haaverstad, Rune; Vitale, Nicola; Karevold, Asbjørn

2006-01-01

OBJECTIVE: The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis. METHODS: From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received...... an aortic advantage valve prosthesis. Complete cumulative follow-up was 242.7 patient-years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography. RESULTS: 30 day mortality was 2.4% (n = 4). Kaplan-Meier estimates of freedom from...... echocardiography. CONCLUSIONS: Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use....

The impact of virus infections on pneumonia mortality is complex in adults: a prospective multicentre observational study.

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Katsurada, Naoko; Suzuki, Motoi; Aoshima, Masahiro; Yaegashi, Makito; Ishifuji, Tomoko; Asoh, Norichika; Hamashige, Naohisa; Abe, Masahiko; Ariyoshi, Koya; Morimoto, Konosuke

2017-12-06

Various viruses are known to be associated with pneumonia. However, the impact of viral infections on adult pneumonia mortality remains unclear. This study aimed to clarify the effect of virus infection on pneumonia mortality among adults stratified by virus type and patient comorbidities. This multicentre prospective study enrolled pneumonia patients aged ≥15 years from September 2011 to August 2014. Sputum samples were tested by in-house multiplex polymerase chain reaction assays to identify 13 respiratory viruses. Viral infection status and its effect on in-hospital mortality were examined by age group and comorbidity status. A total of 2617 patients were enrolled in the study and 77.8% was aged ≥65 years. 574 (21.9%) did not have comorbidities, 790 (30.2%) had chronic respiratory disease, and 1253 (47.9%) had other comorbidities. Viruses were detected in 605 (23.1%) patients. Human rhinovirus (9.8%) was the most frequently identified virus, followed by influenza A (3.9%) and respiratory syncytial virus (3.9%). Respiratory syncytial virus was more frequently identified in patients with chronic respiratory disease (4.7%) than those with other comorbidities (4.2%) and without comorbidities (2.1%) (p = 0.037). The frequencies of other viruses were almost identical between the three groups. Virus detection overall was not associated with increased mortality (adjusted risk ratio (ARR) 0.76, 95% CI 0.53-1.09). However, influenza virus A and B were associated with three-fold higher mortality in patients with chronic respiratory disease but not with other comorbidities (ARR 3.38, 95% CI 1.54-7.42). Intriguingly, paramyxoviruses were associated with dramatically lower mortality in patients with other comorbidities (ARR 0.10, 95% CI 0.01-0.70) but not with chronic respiratory disease. These effects were not affected by age group. The impact of virus infections on pneumonia mortality varies by virus type and comorbidity status in adults.

Role of the internet as an information resource before anaesthesia consultation: A French prospective multicentre survey.

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Nucci, Bastian; Claret, Pierre-Geraud; Leclerc, Gilles; Chaumeron, Arnaud; Grillo, Philippe; Buleon, Clément; Leprince, Vincent; Raux, Mathieu; Minville, Vincent; Futier, Emmanuel; Lefrant, Jean-Yves; Cuvillon, Philippe

2017-12-01

Use of the internet as an information search tool has increased dramatically. Our study assessed preoperative use of the internet by patients to search for information regarding anaesthesia, surgery, pain or outcomes. The aim of this study was to test whether patients used the internet prior to surgery and what kinds of information they looked for (anaesthetic technique, pain, adverse events, outcomes and surgery). Correlation between patient age and information sought about surgery from the internet was also explored. A prospective multicentre observational study. In total, 14 French private and public institutions from May 2015 to January 2016. In total, 3161 adult patients scheduled for elective surgery under regional or general anaesthesia. An anonymous questionnaire was presented to adult patients scheduled for elective surgery under regional or general anaesthesia for completion before the first meeting with the anaesthesiologist. The investigator at each centre completed specific items that the patient could not complete. We defined the primary endpoint as the number of patients who searched for information about their anaesthesia or surgery on the internet by the time of the their preanaesthetic consultation. Of the 3234 questionnaires distributed, responses were received from 3161 patients. Within this respondent sample, 1304 (45%) were professionally active and 1664 (59%) used the internet at least once per day. Among 3098 (98%) patients who answered the question concerning the primary endpoint, 1506 (48%) had searched the internet for information about their health. In total, 784 (25%) used the internet to find information about their surgery and 113 (3.5%) looked for specific information about anaesthesia. Of the 3161, 52% reported difficulty searching for appropriate information about anaesthesia on the internet. 'Daily use of the web' [odds ratio (OR) 2.0; (95% CI: 1.65 to 2.55) P internet was not widely used by patients scheduled for elective

Pregnancy outcomes in Lebanese women with multiple sclerosis (the LeMS study): a prospective multicentre study.

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Fares, Jawad; Nassar, Anwar H; Gebeily, Souheil; Kobeissy, Firas; Fares, Youssef

2016-05-13

The Lebanese Multiple Sclerosis (LeMS) study aims to assess the influence of pregnancy and delivery on the clinical course of multiple sclerosis (MS) in Lebanese women. This prospective multicentre study took place in three MS referral university medical centres in Lebanon. Included were 29 women over 18 years who had been diagnosed with MS according to the McDonald criteria, and became pregnant between 1995 and 2015. Participating women should have stopped treatment 3 months before conception and become pregnant after the onset of MS. Women were followed up from 1 year preconceptionally and for 4 years postpartum. The annualised relapse rates per participant during each 3-month period during pregnancy and each year postpartum were compared with the relapse rate during the year before pregnancy using the paired two-tailed t test. p Values women with MS does not seem to increase the risk of complications. No relapses were observed during pregnancy and in the first year postpartum; however, relapses rebounded in the second year postpartum, and over the long term, returned to the levels that preceded pregnancy. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy.

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Nayak, Chaturbhuja; Oberai, Praveen; Varanasi, Roja; Baig, Hafeezullah; Ch, Raveender; Reddy, G R C; Devi, Pratima; S, Bhubaneshwari; Singh, Vikram; Singh, V P; Singh, Hari; Shitanshu, Shashi Shekhar

2013-04-01

To evaluate homeopathic treatment in the management of diabetic distal symmetric polyneuropathy. A prospective multi-centric clinical observational study was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) (India) at its five institutes/units. Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the diabetic distal symmetric polyneuropathy symptom score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months. Out of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analyzed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only. This study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the quality of life (QOL) assessment. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Multicentre prospective evaluation of implant-assisted mandibular removable partial dentures: surgical and prosthodontic outcomes.

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Payne, Alan G T; Tawse-Smith, Andrew; Wismeijer, Daniel; De Silva, Rohana K; Ma, Sunyoung

2017-01-01

To determine implant survival and prosthodontic maintenance of implant-assisted mandibular removable partial dentures in a multicentre prospective study up to 10 years. Forty-eight participants with mandibular distal extension partial dentures were selected. A control group of 12 New Zealand participants had new conventional mandibular partial dentures made. Three test groups of 36 participants in New Zealand (n = 12), the Netherlands (n = 12) and Colombia (n = 12) had bilateral distal implants placed. Surgical and prosthodontic outcomes were documented with only healing caps placed (Stage 1) and with an attachment system (Stage 2). No implants failed after 3 years. Four late implant failures in three participants occurred in New Zealand (two unilateral implant failures after 5 and 8 years and two bilateral implant failures in the same participant after 6 and 10 years); two unilateral late implant failures occurred in the Netherlands and no late failures in Colombia. Implant survival rate was 92% by 10 years. Resonance frequency measurements were taken at surgery implant stability quotient (ISQ) 62.44 ± 7.46; range 40 - 79), baseline (ISQ 63.22 ± 6.17; range 50 - 74) and after 3 years (ISQ 66.38 ± 6.77; range 55 - 83). In New Zealand and Colombia, measured crestal bone levels were 2.03 ± 0.71 mm and 2.20 ± 0.81 mm, respectively, at baseline and 3 years. For Stage I, principal prosthodontic maintenance issues were loose healing caps among 10 New Zealand participants, four Colombian participants and one Netherlands participant. For Stage 2, matrix activation and overdenture puncture fractures resulted in 41 events (25 participants) in New Zealand over 10 years, whilst over 3 years, there were 14 events in nine Colombian participants and six events in five Netherlands participants. This clinical multicentre research complements previous case reports, case series, retrospective and prospective studies on the notion of implant

The South African Surgical Outcomes Study: A 7-day prospective ...

African Journals Online (AJOL)

To investigate the perioperative mortality and need for critical care admission in patients undergoing inpatient non-cardiac surgery in SA. Methods. A 7-day national, multicentre, prospective, observational cohort study of all patients ≥16 years of age undergoing inpatient noncardiac surgery between 19 and 26 May 2014 at ...

Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

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David Noriega

2015-01-01

Full Text Available This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF of traumatic origin. We enrolled 103 patients (median age: 61.6 years with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS. Secondary outcomes were Oswestry Disability Index (ODI, EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score and in quality of life (increase 21.1% of EQ-VAS score were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4±6.3°; p<0.001, remained at 12 months (-4.4±6.0°, p=0.002. No adverse events were implant-related and none required device removal. Three patients (2.9% experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

A comparison of functional outcome in patients sustaining major trauma: a multicentre, prospective, international study.

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Timothy H Rainer

Full Text Available OBJECTIVES: To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. SUMMARY BACKGROUND DATA: Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR. METHODS: Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE functional outcome and risk-adjusted Short-Form 12 (SF-12 health status at 6 and 12 months after injury. RESULTS: 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17, and at 12 months was 0.83 (95% CI: 0.60, 1.12. Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: -1.2, 3.6 and 12-months (adjusted mean difference: -0.4, 95% CI: -3.2, 2.4 compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: -2.1, 2.8 or 12-months (adjusted mean difference: 1.8, 95% CI: -0.8, 4.5. CONCLUSION: The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions.

A Comparison of Functional Outcome in Patients Sustaining Major Trauma: A Multicentre, Prospective, International Study

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Rainer, Timothy H.; Yeung, Hiu Hung; Gabbe, Belinda J.; Yuen, Kai Y.; Ho, Hiu F.; Kam, Chak W.; Chang, Annice; Poon, Wai S.; Cameron, Peter A.; Graham, Colin A.

2014-01-01

Objectives To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. Summary Background Data Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR). Methods Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE) functional outcome and risk-adjusted Short-Form 12 (SF-12) health status at 6 and 12 months after injury. Results 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17), and at 12 months was 0.83 (95% CI: 0.60, 1.12). Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: −1.2, 3.6) and 12-months (adjusted mean difference: −0.4, 95% CI: −3.2, 2.4) compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: −2.1, 2.8) or 12-months (adjusted mean difference: 1.8, 95% CI: −0.8, 4.5). Conclusion The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions. PMID:25157522

[Sentinel node biopsy in patients with multifocal and multicentric breast cancer: A 5-year follow-up].

Science.gov (United States)

Blanco Saiz, I; López Carballo, M T; Martínez Fernández, J; Carrión Maldonado, J; Cabrera Pereira, A; Moral Alvarez, S; Santamaría Girón, L; Cantero Cerquella, F; López Secades, A; Díaz González, D; Llaneza Folgueras, A; Aira Delgado, F J

2014-01-01

Sentinel lymph node biopsy (SLNB) as a staging procedure in multiple breast cancer is a controversial issue. We have aimed to evaluate the efficacy of sentinel node (SN) detection in patients with multifocal or multicentric breast cancer as well as the safety of its clinical application after a long follow-up. A prospective descriptive study was performed. Eighty-nine patients diagnosed of multiple breast cancer (73 multifocal; 16 multicentric) underwent SLNB. These patients were compared to those with unifocal neoplasia. Periareolar radiocolloid administration was performed in most of the patients. Evaluation was made at an average of 67.2 months of follow-up (32-126 months). Scintigraphic and surgical SN localization in patients with multiple breast cancer were 95.5% and 92.1%, respectively. A higher percentage of extra-axillary nodes was observed than in the unifocal group (11.7% vs 5.4%) as well as a significantly higher number of SN per patient (1.70 vs 1.38). The rate of SN localization in multicentric cancer was slightly lower than in multifocal cancer (87.5% vs 93.1%), and the finding of extra-axillary drainages was higher (20% vs 10%). Number of SN per patient was significantly higher in multicentric breast cancer (2.33 vs 1.57). No axillary relapses have been demonstrated in the follow-up in multiple breast cancer patients group. SLNB performed by periareolar injection is a reliable and accurate staging procedure of patients with multiple breast cancer, including those with multicentric processes. Copyright © 2013 Elsevier España, S.L. and SEMNIM. All rights reserved.

Preoperative predictive model for acute kidney injury after elective cardiac surgery: a prospective multicentre cohort study.

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Callejas, Raquel; Panadero, Alfredo; Vives, Marc; Duque, Paula; Echarri, Gemma; Monedero, Pablo

2018-05-11

Predictive models of CS-AKI include emergency surgery and patients with haemodynamic instability. Our objective was to evaluate the performance of validated predictive models (Thakar and Demirjian) in elective cardiac surgery and to propose a better score in the case of poor performance. A prospective, multicentre, observational study was designed. Data were collected from 942 patients undergoing cardiac surgery, after excluding emergency surgery and patients with an intraaortic balloon pump. The main outcome measure was CS-AKI defined by the composite of requiring dialysis or doubling baseline creatinine values. Both models showed poor discrimination in elective surgery (Thakar's model, AUROC = 0.57, 95% CI = 0.50-0.64 and Demirjian's model, AUROC= 0.64, 95% CI = 0.58-0.71). We generated a new model whose significant independent predictors were: anaemia, age, hypertension, obesity, congestive heart failure, previous cardiac surgery and type of surgery. It classifies patients with scores 0-3 as low risk ( 8 as high risk (>30%) of developing CS-AKI with a statistically significant correlation (p <0.001). Our model reflects acceptable discriminatory ability (AUC = 0.72, 95% CI = 0.66-0.78) which is significantly better than Thakar and Demirjian's models (p<0.01). We developed a new simple predictive model of CS-AKI in elective surgery based on available preoperative information. Our new model is easy to calculate and can be an effective tool for communicating risk to patients and guiding decision-making in the perioperative period. The study requires external validation.

ECSPECT prospective multicentre registry for single-port laparoscopic colorectal procedures

DEFF Research Database (Denmark)

Weiss, Helmut; Zorron, R; Vestweber, K-H

2017-01-01

BACKGROUND: The international multicentre registry ECSPECT (European Consensus of Single Port Expertise in Colorectal Treatment) was established to evaluate the general feasibility and safety of single-port colorectal surgery with regard to preoperative risk assessment. METHODS: Consecutive...... patients undergoing single-port colorectal surgery were enrolled from 11 European centres between March 2010 and March 2014. Data were analysed to assess patient-, technique- and procedure-dependent parameters. A validated sex-adjusted risk chart was developed for prediction of single-port colorectal...

Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT)

NARCIS (Netherlands)

Madsen, M.B.; Skrede, S.; Bruun, T.; Arnell, P.; Rosén, A.; Nekludov, M.; Karlsson, Y.; Bergey, F.; Saccenti, E.; Martins dos Santos, V.A.P.; Perner, A.; Norrby-Teglund, A.; Hyldegaard, O.

2018-01-01

Background: The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections (NSTIs). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTIs and correlating

Lung volume reduction coil treatment for patients with severe emphysema : a European multicentre trial

NARCIS (Netherlands)

Deslee, Gaetan; Klooster, Karin; Hetzel, Martin; Stanzel, Franz; Kessler, Romain; Marquette, Charles-Hugo; Witt, Christian; Blaas, Stefan; Gesierich, Wolfgang; Herth, Felix J. F.; Hetzel, Juergen; van Rikxoort, Eva M.; Slebos, Dirk-Jan

2014-01-01

Background The lung volume reduction (LVR) coil is a minimally invasive bronchoscopic nitinol device designed to reduce hyperinflation and improve elastic recoil in severe emphysema. We investigated the feasibility, safety and efficacy of LVR coil treatment in a prospective multicentre cohort trial

A Prospective Observational Study

African Journals Online (AJOL)

Methods: This was a prospective, questionnaire-based observational study. Printed questionnaires were distributed to the visitors of medical, surgical and neurosurgical ICU patients to determine awareness of basic infection control practices among visitors to an ICU. All the ICU staff, including nurses, doctors, consultant ...

Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study.

Science.gov (United States)

Noriega, David; Krüger, Antonio; Ardura, Francisco; Hansen-Algenstaedt, Nils; Hassel, Frank; Barreau, Xavier; Beyerlein, Jörg

2015-01-01

The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

Clinical Outcome after the Use of a New Craniocaudal Expandable Implant for Vertebral Compression Fracture Treatment: One Year Results from a Prospective Multicentric Study

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David Noriega

2015-01-01

Full Text Available The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

Multicentric reticulohistiocytosis (lipoid dermatoarthritis)

International Nuclear Information System (INIS)

Fiumicelli, A.; Bruni, L.

1990-01-01

The authors report their experience with 3 cases of multicentric reticulohistiocytosis observed over 6 years of outpatient radiological practice. The condition presents with the following radiological patterns: 1) clear-cut erosions of the articular surfaces, especially in the distal interphalangeal joints of the hand and in the metatarso-phalangeal joints of the feet, with symmetrical distributions (not necessarily); 2) osteolytic punched-out areas in the epiphyseal spongiosa, ranging in size from 1 mm to over 1 cm; 3) no osteoporosis, no osteoproliferative or periosteal reactions, not even in the presence of large osteoarticular destructions; 4) frequent atlanto-epistropheal subluxation; 5) articular ankylosis at the sacroiliac joints only. The association of the above patterns and the relativity benign clinical course distinguish multicentric reticulohistiocytosis from rheumatoid arthritis, psoriasic arthritis, erosive osteoarthritis, and gout. Reliable diagnosis can be suggested on the basis of radiological findings alone, even before cutaneous or mucosal lesions appear -which are, at any rate, not sure to appear and typical of nails only. An unquestionable diagnosis can be made at histology of synovial and/or cutaneous nodules. Multicentric reticulohistiocytosis is considered an uncommon condition (nearly 100 cases in international literature to 1989); the authors believe it to be commoner though often misdiagnosed as a 'variant of rehumatoid arthritis'

Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies

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Marent Marta

2010-11-01

Full Text Available Abstract Background With an ever-increasing elderly population, orthopaedic surgeons are faced with treating a high number of fragility fractures. Biomechanical tests have demonstrated the potential role of osteoporosis in the increased risk of fracture fixation complications, yet this has not been sufficiently proven in clinical practice. Based on this knowledge, two clinical studies were designed to investigate the influence of local bone quality on the occurrence of complications in elderly patients with distal radius and proximal humerus fractures treated by open reduction and internal fixation. Methods/Design The studies were planned using a prospective multicentre open cohort design and included patients between 50 and 90 years of age. Distal radius and proximal humerus fractures were treated with locking compression 2.4 mm and proximal humerus internal locking plates, respectively. Follow-up examinations were planned for 6 weeks, 3 and 12 months as well as a telephone interview at 6 months. The primary outcome focuses on the occurrence of at least one local bone quality related complication. Local bone quality is determined by measuring bone mineral density and bone mineral content at the contralateral radius. Primary complications are categorised according to predefined factors directly related to the bone/fracture or the implant/surgical technique. Secondary outcomes include the documentation of soft tissue/wound or general/systemic complications, clinical assessment of range of motion, and patient-rated evaluations of upper limb function and quality of life using both objective and subjective measures. Discussion The prospective multicentre open cohort studies will determine the value of local bone quality as measured by bone mineral density and content, and compare the quality of local bone of patients who experience a complication (cases following surgery with that of patients who do not (controls. These measurements are novel and

Haptic-based neurorehabilitation in poststroke patients: a feasibility prospective multicentre trial for robotics hand rehabilitation.

Science.gov (United States)

Turolla, Andrea; Daud Albasini, Omar A; Oboe, Roberto; Agostini, Michela; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Venneri, Annalena; Piron, Lamberto

2013-01-01

Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

Multicentre prospective evaluation of implant-assisted mandibular bilateral distal extension removable partial dentures: patient satisfaction.

Science.gov (United States)

Wismeijer, Daniel; Tawse-Smith, Andrew; Payne, Alan G T

2013-01-01

To compare the levels of patient satisfaction with either conventional mandibular bilateral distal extension partial dentures or those assisted by bilateral distal implants. Forty-eight participants who were dissatisfied with their existing conventional mandibular distal extension dentures opposing complete maxillary dentures were selected for a multicentre prospective study in New Zealand, Colombia and the Netherlands. A control group of 12 participants in New Zealand received conventional mandibular partial dentures. Three test groups involving 36 participants in New Zealand (12), Colombia (12) and the Netherlands (12) received bilateral distal implants in the second molar regions. After conventional loading, the test group participants initially had healing caps placed on the distal implants providing support only, followed after approximately 6 months by ball abutments (retentive anchors) for support and retention. Patient outcomes were determined with questionnaires completed at specific stages of the study for up to 3 years. Visual analogue scale, Likert and oral health impact questionnaires before and after treatment indicated improved results. There were significantly improved parameters of overall satisfaction, stability, chewing and appearance after 3 years (P removable partial dentures are a preferable treatment option for patients with complaints about their conventional distal extension partial dentures. © 2011 John Wiley & Sons A/S.

Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

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Andrea Turolla

2013-01-01

Full Text Available Background. Haptic robots allow the exploitation of known motorlearning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

Prospective multicentre cohort study of heparin-induced thrombocytopenia in acute ischaemic stroke patients

Science.gov (United States)

Kawano, Hiroyuki; Yamamoto, Haruko; Miyata, Shigeki; Izumi, Manabu; Hirano, Teruyuki; Toratani, Naomi; Kakutani, Isami; Sheppard, Jo-Ann I; Warkentin, Theodore E; Kada, Akiko; Sato, Shoichiro; Okamoto, Sadahisa; Nagatsuka, Kazuyuki; Naritomi, Hiroaki; Toyoda, Kazunori; Uchino, Makoto; Minematsu, Kazuo

2011-01-01

Acute ischaemic stroke patients sometimes receive heparin for treatment and/or prophylaxis of thromboembolic complications. This study was designed to elucidate the incidence and clinical features of heparin-induced thrombocytopenia (HIT) in acute stroke patients treated with heparin. We conducted a prospective multicentre cohort study of 267 patients who were admitted to three stroke centres within 7 d after stroke onset. We examined clinical data until discharge and collected blood samples on days 1 and 14 of hospitalization to test anti-platelet factor 4/heparin antibodies (anti-PF4/H Abs) using an enzyme-linked immunosorbent assay (ELISA); platelet-activating antibodies were identified by serotonin-release assay (SRA). Patients with a 4Ts score ≥4 points, positive-ELISA, and positive-SRA were diagnosed as definite HIT. Heparin was administered to 172 patients (64·4%: heparin group). Anti-PF4/H Abs were detected by ELISA in 22 cases (12·8%) in the heparin group. Seven patients had 4Ts ≥ 4 points. Among them, three patients (1·7% overall) were also positive by both ELISA and SRA. National Institutes of Health Stroke Scale score on admission was high (range, 16–23) and in-hospital mortality was very high (66·7%) in definite HIT patients. In this study, the incidence of definite HIT in acute ischaemic stroke patients treated with heparin was 1·7% (95% confidence interval: 0·4–5·0). The clinical severity and outcome of definite HIT were unfavourable. PMID:21671895

Implementing diffusion-weighted MRI for body imaging in prospective multicentre trials. Current considerations and future perspectives

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DeSouza, N.M.; Winfield, J.M.; Weller, A.; Papoutsaki, M.V.; Doran, S.J.; Collins, D.J. [Institute of Cancer Research and Royal Marsden NHS Foundation Trust, CRUK Cancer Imaging Centre, Surrey (United Kingdom); Waterton, J.C.; Jackson, A. [University of Manchester, Manchester Academic Health Sciences Institute, Manchester (United Kingdom); Fournier, L. [Universite Paris Descartes Sorbonne Paris Cite, Assistance Publique-Hopitaux de Paris, Hopital Europeen Georges Pompidou, Radiology Department, Paris (France); Sullivan, D. [Duke Comprehensive Cancer Institute, Durham, NC (United States); Chenevert, T. [University of Michigan Health System, Department of Radiology, Ann Arbor, MI (United States); Boss, M. [National Institute of Standards and Technology (NIST), Applied Physics Division, Boulder, CO (United States); Trattnig, S. [Medical University of Vienna, Department of Biomedical Imaging and Image Guided Therapy, Vienna (Austria); Liu, Y. [European Organisation for Research and Treatment of Cancer, Brussels (Belgium)

2018-03-15

For body imaging, diffusion-weighted MRI may be used for tumour detection, staging, prognostic information, assessing response and follow-up. Disease detection and staging involve qualitative, subjective assessment of images, whereas for prognosis, progression or response, quantitative evaluation of the apparent diffusion coefficient (ADC) is required. Validation and qualification of ADC in multicentre trials involves examination of i) technical performance to determine biomarker bias and reproducibility and ii) biological performance to interrogate a specific aspect of biology or to forecast outcome. Unfortunately, the variety of acquisition and analysis methodologies employed at different centres make ADC values non-comparable between them. This invalidates implementation in multicentre trials and limits utility of ADC as a biomarker. This article reviews the factors contributing to ADC variability in terms of data acquisition and analysis. Hardware and software considerations are discussed when implementing standardised protocols across multi-vendor platforms together with methods for quality assurance and quality control. Processes of data collection, archiving, curation, analysis, central reading and handling incidental findings are considered in the conduct of multicentre trials. Data protection and good clinical practice are essential prerequisites. Developing international consensus of procedures is critical to successful validation if ADC is to become a useful biomarker in oncology. (orig.)

Discontinuation of tofacitinib after achieving low disease activity in patients with rheumatoid arthritis: a multicentre, observational study.

Science.gov (United States)

Kubo, Satoshi; Yamaoka, Kunihiro; Amano, Koichi; Nagano, Shuji; Tohma, Shigeto; Suematsu, Eiichi; Nagasawa, Hayato; Iwata, Kanako; Tanaka, Yoshiya

2017-08-01

To determine whether tofacitinib can be discontinued in patients with RA who achieve low disease activity (LDA). RA patients with LDA after tofacitinib treatment in a phase III and long-term extension study were enrolled in this multicentre, non-randomized, open, prospective, observational study. The decision of discontinuation or continuation of tofacitinib was determined based on patient-physician decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib-free at post-treatment week 52. Clinical outcome was compared between those who continued and those who discontinued tofacitinib. The last observation carried forward method was used for patients who could not discontinue tofacitinib before week 52. Of 64 patients, 54 discontinued and 10 continued tofacitinib therapy. At post-treatment week 52, 20 of the 54 patients (37%) of the discontinuation group remained tofacitinib-free without disease flare. Disease activity at post-treatment week 52 was higher in the discontinuation group than the continuation group. Among the discontinuation group, the RF titre at baseline was significantly lower in patients who remained tofacitinib-free than those who did not (40 vs 113 U/ml). In fact, a higher proportion of patients with lower RF remained tofacitinib-free at week 52 compared with those with higher RF at baseline. In patients who could not achieve tofacitinib-free status, re-initiation of tofacitinib or other biologics improved disease activity. It is possible to discontinue tofacitinib without flare in about a third of patients with RA. A low RF predicts maintenance of LDA after discontinuation of tofacitinib. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Prospective Multicentre Study on the Epidemiology and Current Therapeutic Management of Severe Bronchiolitis in Spain

Directory of Open Access Journals (Sweden)

Jose C. Flores-González

2017-01-01

Full Text Available Objective. To determine the epidemiology and therapeutic management of patients with severe acute bronchiolitis (AB admitted to paediatric intensive care units (PICUs in Spain. Design. Descriptive, prospective, multicentre study. Setting. Sixteen Spanish PICUs. Patients. Patients with severe AB who required admission to any of the participating PICUs over 1 year. Interventions. Both epidemiological variables and medical treatment received were recorded. Results. A total of 262 patients were recruited; 143 were male (54.6%, with median age of 1 month (0–23. Median stay in the PICU was 7 days (1–46. Sixty patients (23% received no nebuliser treatment, while the rest received a combination of inhalation therapies. One-quarter of patients (24.8% received corticosteroids and 56.5% antibiotic therapy. High-flow oxygen therapy was used in 14.3% and noninvasive ventilation (NIV was used in 75.6%. Endotracheal intubation was required in 24.4% of patients. Younger age, antibiotic therapy, and invasive mechanical ventilation (IMV were risk factors that significantly increased the stay in the PICU. Conclusions. Spanish PICUs continue to routinely use nebulised bronchodilator treatment and corticosteroid therapy. Despite NIV being widely used in this condition, intubation was required in one-quarter of cases. Younger age, antibiotic therapy, and IMV were associated with a longer stay in the PICU.

Prospective evaluation of the International Neuroblastoma Staging System (INSS) and the International Neuroblastoma Response Criteria (INRC) in a multicentre setting.

Science.gov (United States)

Castel, V; García-Miguel, P; Cañete, A; Melero, C; Navajas, A; Ruíz-Jiménez, J I; Navarro, S; Badal, M D

1999-04-01

The aim of this study was to classify prospectively a series of neuroblastoma tumours according to the International Neuroblastoma Staging System (INSS) and the International Neuroblastoma Response Criteria (INRC) and to evaluate the difficulties and pitfalls involved in a multicentre setting. Each hospital provided their data for central review. The surgical procedures and their complications were reported. Kaplan-Meier estimates of survival and event-free survival were calculated according to stage and response to therapy. From June 1992 to December 1996, 194 patients were included in the study, with a mean age of 2 years. Initial studies were performed according to INSS recommendations without major problems. INSS stage was correctly applied to all patients except for 9 (95%). Post-operative complications were observed in 15 patients (8.3%). Response to therapy (INRC) was studied in 63 stage 4 patients, 11 of whom were not classified correctly (17%). Differences in survival according to stage (INSS) and group of response to therapy (INRC) were statistically significant (P INSS was easy to use and separated different prognostic groups. Surgical complications and mortality did not increase in this series because of using the INSS. The feasibility of INRC was evaluated in a small series of stage 4 patients and the designation of response was problematic in a relatively high proportion of cases. The prognostic value of the different responses was highly significant, but less informative than had been hoped for.

Building a Multi-centre Clinical Research Facilitation Network: The ARC Experience

Directory of Open Access Journals (Sweden)

Ian Nicholson

2017-06-01

interest from general practitioner members but as yet no studies of general practice procedures have been forthcoming.Discussion: Vets want to be involved with clinical research. ARC has had early successes and will continue to grow - though more work is needed to encourage general practitioner members. Multi-centre research allows more cases to be recruited more quickly, adding weight to studies and shortening the period of data-gathering. These initial retrospective studies have generated a committed core of individuals seeking to create prospective studies together. An online tool is planned, to facilitate real-time case-recruitmentfor prospective multi-centre studies including randomised controlled trials. Anyone can join ARC, please email inicholsonvet@gmail.com.

Cardiac mucosa at the gastro-oesophageal junction: indicator of gastro-oesophageal reflux disease? Data from a prospective central European multicentre study on histological and endoscopic diagnosis of oesophagitis (histoGERD trial).

Science.gov (United States)

Langner, Cord; Schneider, Nora I; Plieschnegger, Wolfgang; Schmack, Bertram; Bordel, Hartmut; Höfler, Bernd; Eherer, Andreas J; Wolf, Eva-Maria; Rehak, Peter; Vieth, Michael

2014-07-01

The origin and significance of cardiac mucosa at the gastro-oesophageal junction are controversial. In the prospective Central European multicentre histoGERD trial, we aimed to assess the prevalence of cardiac mucosa, characterized by the presence of glands composed of mucous cells without parietal cells, and to relate its presence to features related to gastro-oesophageal reflux disease (GORD). One thousand and seventy-one individuals (576 females and 495 males; median age 53 years) were available for analysis. Overall, in biopsy specimens systematically taken from above and below the gastro-oesophageal junction, cardiac mucosa was observed in 713 (66.6%) individuals. Its presence was associated with patients' symptoms and/or complaints (P = 0.0025), histological changes of the squamous epithelium (P gastro-oesophageal junction. Its association with reflux symptoms, histological changes indicating GORD and the endoscopic diagnosis of oesophagitis suggests that injury and repair related to GORD contribute to its development and/or expansion. © 2014 John Wiley & Sons Ltd.

Local epidemiology and resistance profiles in acute uncomplicated cystitis (AUC) in women: a prospective cohort study in an urban urological ambulatory setting.

Science.gov (United States)

Seitz, Michael; Stief, Christian; Waidelich, Raphaela

2017-10-16

Acute uncomplicated cystitis (AUC) is a common ailment in the urological setting. Guidelines for urinary tract infections are based on large-scale multi-centre, epidemiological and international studies. The objective of this observational study was to establish whether the results of a multi-centre study on the resistance profile of Escherichia coli (E. coli) in patients with AUC could be directly applied to an urological practice in a major European city or whether there are divergences in the resistance profile. An observational study was applied prospectively to 502 patients with AUC between January 2015 and January 2017). Personal data were anonymised. Exclusion criteria were the patient's age (AUC should therefore only be treated with TRS, CIP and AMC after a susceptibility test has been carried out.

Scintimammography with technetium-99m methoxyisobutylisonitrile: results of a prospective European multicentre trial

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Palmedo, H.; Biersack, H.J. [Bonn Univ. (Germany). Dept. of Nucl. Med.; Lastoria, S. [Department of Nuclear Medicine, National Cancer Institute of Naples (Italy); Maublant, J. [Department of Nuclear Medicine, Centre Jean Perrin in Clermont Ferrand (France); Prats, E. [Department of Nuclear Medicine, University Hospital of Zaragoza (Spain); Stegner, H.E. [Department of Gynecology, University of Hamburg (Germany); Bourgeois, P. [Department of Nuclear Medicine, Hospital St. Pierre in Bruxelles (Belgium); Hustinx, R. [Department of Nuclear Medicine, University Hospital in Liege (Belgium); Hilson, A.J.W. [Department of Nuclear Medicine, NHS Trust Hospital in London (United Kingdom); Bischof-Delaloye, A. [Department of Nuclear Medicine, University of Lausanne (Switzerland)

1998-04-01

The aim of the trial was to determine the diagnostic accuracy of scintimmammography with technetium-99m methoxyisobutylisonitrile ({sup 99m}Tc-MIBI) in the detection of primary breast cancer and to verify its clinical usefulness. A total of 246 patients with a suspicious breast mass or positive mammogram were included in this prospective European multicentre trial. At 5 min and 60 min (optional) p.i. two lateral prone images were acquired for 10 min each; 30 min p.i. one anterior image was acquired for 10 min. There were 253 lesions (195 palpable and 58 non-palpable), in respect of which histology revealed 165 cancers and 88 benign lesions. Institutional and blinded read results were correlated to core laboratory histopathology results obtained during excisional biopsy. Diagnostic accuracy for the detection of breast cancer was calculated per lesion. The overall sensitivity and specificity of blinded read scintimammography were 71% and 69%, respectively. For palpable lesions, the sensitivity of blinded read and institutional read scintimammography was 83% and 91%, respectively. Sensitivity was not dependent on the density of the breast tissue. Invasive ductal and invasive lobular cancers showed similar sensitivity. The sensitivity and specificity of mammography were 91% and 42%, respectively, and did not depend on the tumour size. In 60% of false-negative mammograms, {sup 99m}Tc-MIBI was able to diagnose malignancy (true-positive). High-quality imaging with {sup 99m}Tc-MIBI has a high diagnostic accuracy for the detection of primary breast cancer. Used as a complementary method, scintimammography with {sup 99m}Tc-MIBI can help to diagnose breast cancer at an earlier stage in patients with dense breasts. (orig.) With 6 figs., 12 tabs., 55 refs.

Influence of social support on cognitive change and mortality in old age: results from the prospective multicentre cohort study AgeCoDe

Science.gov (United States)

2012-01-01

Background Social support has been suggested to positively influence cognition and mortality in old age. However, this suggestion has been questioned due to inconsistent operationalisations of social support among studies and the small number of longitudinal studies available. This study aims to investigate the influence of perceived social support, understood as the emotional component of social support, on cognition and mortality in old age as part of a prospective longitudinal multicentre study in Germany. Methods A national subsample of 2,367 primary care patients was assessed twice over an observation period of 18 months regarding the influence of social support on cognitive function and mortality. Perceived social support was assessed using the 14-item version of the FSozU, which is a standardised and validated questionnaire of social support. Cognition was tested by the neuropsychological test battery of the Structured Interview for the Diagnosis of Dementia (SIDAM). The influence of perceived support on cognitive change was analysed by multivariate ANCOVA; mortality was analysed by multivariate logistic and cox regression. Results Sample cognitive change (N = 1,869): Mean age was 82.4 years (SD 3.3) at the beginning of the observation period, 65.9% were female, mean cognition was 49 (SD 4.4) in the SIDAM. Over the observation period cognitive function declined in 47.2% by a mean of 3.4 points. Sample mortality (N = 2,367): Mean age was 82.5 years (SD 3.4), 65.7% were female and 185 patients died during the observation period. Perceived social support showed no longitudinal association with cognitive change (F = 2.235; p = 0.135) and mortality (p = 0.332; CI 0.829-1.743). Conclusions Perceived social support did not influence cognition and mortality over an 18 months observation period. However, previous studies using different operationalisations of social support and longer observation periods indicate that such an influence may exist. This influence is

Morbidity and mortality in a large series of surgical patients with pulmonary metastases of colorectal carcinoma: a prospective multicentre Spanish study (GECMP-CCR-SEPAR).

Science.gov (United States)

Rodríguez-Fuster, Alberto; Belda-Sanchis, José; Aguiló, Rafael; Embun, Raul; Mojal, Sergio; Call, Sergi; Molins, Laureano; Rivas de Andrés, Juan José

2014-04-01

Little information is available on postoperative morbidity and mortality after pulmonary metastasectomy. We describe the postoperative morbidity and mortality in a large multicentre series of patients after a first surgical procedure for pulmonary metastases of colorectal carcinoma (CRC) and identify the pre- and intraoperative variables influencing the clinical outcome. A prospective, observational and multicentre study was conducted. Data were collected from March 2008 to February 2010. Patients were grouped into Groups A and B according to the presence or absence of postoperative complications. Variables in both groups were compared by univariate and multivariate analyses. P-values of <0.05 were considered statistically significant. A total of 532 patients (64.5% males) from 32 hospitals were included. The mean (SD) ages of both study groups were similar [68 (10) vs 67 (10) years, P = NS). A total of 1050 lung resections were performed (90% segmentectomies or wedge, n = 946 and 10% lobectomies or greater, n = 104). Group A included 83 (15.6%) patients who developed a total of 100 complications. These included persistent air leaks in 18, atelectasis in 13, pneumonia in 13, paralytic ileum in 12, arrhythmia in 9, acute respiratory distress syndrome in 4 and miscellanea in 31. Reoperation was performed in 5 (0.9%) patients due to persistent air leaks in 4 and lung ischaemia in 1. The mortality rate was 0.4% (n = 2). Causes of death were sepsis in 1 patient and ventricular fibrillation in 1. In the multivariate analysis, lobectomy or greater lung resection [odds ration (OR) 1.9, 95% confidence interval (95% CI) 1.04-3.3, P = 0.03], respiratory co-morbidity (OR 2.3, 95% CI 1.1-4.6, P = 0.01) and cardiovascular co-morbidity (OR 2, 95% CI 1-3.8, P = 0.02) were independent risk factors for postoperative morbidity. Video-assisted surgery vs thoracotomy showed a protective effect (OR 0.3, 95% CI 0.1-0.8, P = 0.01). The first episode of lung surgery for pulmonary

Blood transfusion in patients having caesarean section: a prospective multicentre observational study of practice in three Pakistan hospitals.

Science.gov (United States)

Ismail, S; Siddiqui, S; Shafiq, F; Ishaq, M; Khan, S

2014-08-01

Increasing awareness of the risks of blood transfusion has prompted examination of red cell transfusion practice in obstetrics. A six-month prospective observational study was performed to examine blood transfusion practices in patients undergoing caesarean delivery at three hospitals in Pakistan. In the three hospitals (two private, one public) 3438 caesarean deliveries were performed in the study period. Data were collected on patient demographics, indications for transfusion, ordering physicians, consent, associations with obstetric factors, estimated allowable blood loss, calculated blood loss, pre- and post-transfusion haemoglobin and discharge haemoglobin. A total number of 397 (11.5%) patients who underwent caesarean section received a blood transfusion. The highest transfusion rate of 16% was recorded in the public tertiary care hospital compared to 5% in the two private hospitals. Emergency caesarean delivery and multiparity were associated with blood transfusion (Ptransfusion in 98% of cases. In 343 (86%) patients, blood transfusion was given even when the haemoglobin was >7g/dL. The method for documenting the indication or consent for transfusion was not found in any of the three hospitals. Blood transfusion was prescribed more readily in the public hospital. Identification of a transfusion trigger and the development of institutional guidelines to reduce unnecessary transfusion are required. Copyright © 2014 Elsevier Ltd. All rights reserved.

Cerebral sinus venous thromboses in children with acute lymphoblastic leukaemia - a multicentre study from the Nordic Society of Paediatric Haematology and Oncology

DEFF Research Database (Denmark)

Ranta, Susanna; Tuckuviene, Ruta; Mäkipernaa, Anne

2014-01-01

We present a prospective multicentre cohort of 20 children with acute lymphoblastic leukaemia (ALL) and cerebral sinus venous thrombosis (CSVT). The study covers a period of 5 years and comprises 1038 children treated according to the Nordic Society of Paediatric Haematology and Oncology (NOPHO...

Coronary CT angiography using 64 detector rows: methods and design of the multi-centre trial CORE-64

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Miller, Julie M.; Vavere, Andrea L.; Arbab-Zadeh, Armin; Bush, David E.; Lardo, Albert C.; Texter, John; Brinker, Jeffery; Lima, Joao A.C. [Johns Hopkins Hospital, Johns Hopkins University, Department of Medicine, Division of Cardiology, Baltimore, MD (United States); Dewey, Marc [Charite - Universitaetsmedizin Berlin, Medical School, Humboldt-Universitaet und Freie Universitaet zu Berlin, Department of Radiology, Berlin, PO Box 10098 (Germany); Rochitte, Carlos E.; Lemos, Pedro A. [University of Sao Paulo Medical School, Heart Institute (InCor), Sao Paulo (Brazil); Niinuma, Hiroyuki [Iwate Medical University, Department of Cardiology, Morioka (Japan); Paul, Narinder [Toronto General Hospital, Department of Medical Imaging, Toronto (Canada); Hoe, John [Medi-Rad Associates Ltd, CT Centre, Mt Elizabeth Hospital, Singapore (Singapore); Roos, Albert de [Leiden University Medical Center, Department of Radiology, Leiden (Netherlands); Yoshioka, Kunihiro [Iwate Medical University, Department of Radiology, Morioka (Japan); Cox, Christopher [Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology, Baltimore, MD (United States); Clouse, Melvin E. [Harvard University, Department of Radiology, Beth Israel Deaconess, Boston, MA (United States)

2009-04-15

Multislice computed tomography (MSCT) for the noninvasive detection of coronary artery stenoses is a promising candidate for widespread clinical application because of its non-invasive nature and high sensitivity and negative predictive value as found in several previous studies using 16 to 64 simultaneous detector rows. A multi-centre study of CT coronary angiography using 16 simultaneous detector rows has shown that 16-slice CT is limited by a high number of nondiagnostic cases and a high false-positive rate. A recent meta-analysis indicated a significant interaction between the size of the study sample and the diagnostic odds ratios suggestive of small study bias, highlighting the importance of evaluating MSCT using 64 simultaneous detector rows in a multi-centre approach with a larger sample size. In this manuscript we detail the objectives and methods of the prospective ''CORE-64'' trial (''Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography using 64 Detectors''). This multi-centre trial was unique in that it assessed the diagnostic performance of 64-slice CT coronary angiography in nine centres worldwide in comparison to conventional coronary angiography. In conclusion, the multi-centre, multi-institutional and multi-continental trial CORE-64 has great potential to ultimately assess the per-patient diagnostic performance of coronary CT angiography using 64 simultaneous detector rows. (orig.)

Serum C-reactive protein concentration as an indicator of remission status in dogs with multicentric lymphoma

DEFF Research Database (Denmark)

Nielsen, Lise; Toft, Nils; Eckersall, David

2007-01-01

Background: The acute-phase protein C-reactive protein (CRP) is used as a diagnostic and prognostic marker in humans with various neoplasias, including non-Hodgkin's lymphoma. Objective: To evaluate if CRP could be used to detect different remission states in dogs with lymphoma. Animals: Twenty......-two dogs with untreated multicentric lymphoma. Methods: Prospective observational study. Blood samples were collected at the time of diagnosis, before each chemotherapy session, and at follow-up visits, resulting in 287 serum samples. Results: Before therapy, a statistically significant majority...... of the dogs (P = .0019) had CRP concentrations above the reference range (68%, 15/22). After achieving complete remission 90% (18/20) of the dogs had CRP concentrations within the reference range, and the difference in values before and after treatment was statistically significant (P

PIpelle Prospective ENDOmetrial carcinoma (PIPENDO) study, pre-operative recognition of high risk endometrial carcinoma: a multicentre prospective cohort study

International Nuclear Information System (INIS)

Visser, Nicole C. M.; Bulten, Johan; Wurff, Anneke A. M. van der; Boss, Erik A.; Bronkhorst, Carolien M.; Feijen, Harrie W. H.; Haartsen, Joke E.; Herk, Hilde A. D. M. van; Kievit, Ineke M. de; Klinkhamer, Paul J. J. M.; Pijlman, Brenda M.; Snijders, Marc P. M. L.; Vandenput, Ingrid; Vos, M. Caroline; Wit, Peter E. J. de; Poll-Franse, Lonneke V. van de; Massuger, Leon F.A.G.; Pijnenborg, Johanna M. A.

2015-01-01

Endometrial carcinoma is the most common gynaecologic malignancy in industrialised countries and the incidence is still rising. Primary treatment is based on preoperative risk classification and consists in most cases of hysterectomy with bilateral salpingo-oophorectomy. In patients with serous and clear cell histology a complete surgical staging is mandatory. However, in routine clinical practice final histology regularly does not correspond with the preoperative histological diagnosis. This results in both over and under treatment. The aim of this multicentre, prospective cohort study is to select a panel of prognostic biomarkers to improve preoperative diagnosis of endometrial carcinoma in order to identify those patients that need extended surgery and/or additional treatment. Additionally, we will determine whether incorporation of cervical cytology and comorbidity could improve this preoperative risk classification. All patients treated for endometrial carcinoma in the participating hospitals from September 2011 till December 2013 are included. Patient characteristics, as well as comorbidity are registered. Patients without preoperative histology, history of hysterectomy and/or endometrial carcinoma or no surgical treatment including hysterectomy are excluded. The preoperative histology and final pathology will be reviewed and compared by expert pathologists. Additional immunohistochemical analysis of IMP3, p53, ER, PR, MLH1, PTEN, beta-catenin, p16, Ki-67, stathmin, ARID1A and L1CAM will be performed. Preoperative histology will be compared with the final pathology results. Follow-up will be at least 24 months to determine risk factors for recurrence and outcome. This study is designed to improve surgical treatment of endometrial carcinoma patients. A total of 432 endometrial carcinoma patients were enrolled between 2011 and 2013. Follow-up will be completed in 2015. Preoperative histology will be evaluated systematically and background endometrium will be

Automatic segmentation of male pelvic anatomy on computed tomography images: a comparison with multiple observers in the context of a multicentre clinical trial.

Science.gov (United States)

Geraghty, John P; Grogan, Garry; Ebert, Martin A

2013-04-30

This study investigates the variation in segmentation of several pelvic anatomical structures on computed tomography (CT) between multiple observers and a commercial automatic segmentation method, in the context of quality assurance and evaluation during a multicentre clinical trial. CT scans of two prostate cancer patients ('benchmarking cases'), one high risk (HR) and one intermediate risk (IR), were sent to multiple radiotherapy centres for segmentation of prostate, rectum and bladder structures according to the TROG 03.04 "RADAR" trial protocol definitions. The same structures were automatically segmented using iPlan software for the same two patients, allowing structures defined by automatic segmentation to be quantitatively compared with those defined by multiple observers. A sample of twenty trial patient datasets were also used to automatically generate anatomical structures for quantitative comparison with structures defined by individual observers for the same datasets. There was considerable agreement amongst all observers and automatic segmentation of the benchmarking cases for bladder (mean spatial variations segmenting a prostate with considerably more volume (mean +113.3%) than that automatically segmented. Similar results were seen across the twenty sample datasets, with disagreement between iPlan and observers dominant at the prostatic apex and superior part of the rectum, which is consistent with observations made during quality assurance reviews during the trial. This study has demonstrated quantitative analysis for comparison of multi-observer segmentation studies. For automatic segmentation algorithms based on image-registration as in iPlan, it is apparent that agreement between observer and automatic segmentation will be a function of patient-specific image characteristics, particularly for anatomy with poor contrast definition. For this reason, it is suggested that automatic registration based on transformation of a single reference dataset

Utility of CSF biomarkers in psychiatric disorders: a national multicentre prospective study.

Science.gov (United States)

Paquet, Claire; Magnin, Eloi; Wallon, David; Troussière, Anne-Cécile; Dumurgier, Julien; Jager, Alain; Bellivier, Frank; Bouaziz-Amar, Elodie; Blanc, Frédéric; Beaufils, Emilie; Miguet-Alfonsi, Carole; Quillard, Muriel; Schraen, Susanna; Pasquier, Florence; Hannequin, Didier; Robert, Philippe; Hugon, Jacques; Mouton-Liger, François

2016-06-13

Affective and psychotic disorders are mental or behavioural patterns resulting in an inability to cope with life's ordinary demands and routines. These conditions can be a prodromal event of Alzheimer's disease (AD). The prevalence of underlying AD lesions in psychiatric diseases is unknown, and it would be helpful to determine them in patients. AD cerebrospinal fluid (CSF) biomarkers (amyloid β, tau and phosphorylated tau) have high diagnostic accuracy, both for AD with dementia and to predict incipient AD (mild cognitive impairment due to AD), and they are sometimes used to discriminate psychiatric diseases from AD. Our objective in the present study was to evaluate the clinical utility of CSF biomarkers in a group of patients with psychiatric disease as the main diagnosis. In a multicentre prospective study, clinicians filled out an anonymous questionnaire about all of their patients who had undergone CSF biomarker evaluation. Before and after CSF biomarker results were obtained, clinicians provided a diagnosis with their level of confidence and information about the treatment. We included patients with a psychiatric disorder as the initial diagnosis. In a second part of the study conducted retrospectively in a followed subgroup, clinicians detailed the psychiatric history and we classified patients into three categories: (1) psychiatric symptoms associated with AD, (2) dual diagnosis and (3) cognitive decline not linked to a neurodegenerative disorder. Of 957 patients, 69 had an initial diagnosis of a psychiatric disorder. Among these 69 patients, 14 (20.2 %) had a CSF AD profile, 5 (7.2 %) presented with an intermediate CSF profile and 50 (72.4 %) had a non-AD CSF profile. Ultimately, 13 (18.8 %) patients were diagnosed with AD. We show that in the AD group psychiatric symptoms occurred later and the delay between the first psychiatric symptoms and the cognitive decline was shorter. This study revealed that about 20 % of patients with a primary

Inflammatory Bowel Disease Phenotype as Risk Factor for Cancer in a Prospective Multicentre Nested Case-Control IG-IBD Study.

Science.gov (United States)

Biancone, Livia; Armuzzi, Alessandro; Scribano, Maria Lia; D'Inca, Renata; Castiglione, Fabiana; Papi, Claudio; Angelucci, Erika; Daperno, Marco; Mocciaro, Filippo; Riegler, Gabriele; Fries, Walter; Meucci, Gianmichele; Alvisi, Patrizia; Spina, Luisa; Ardizzone, Sandro; Petruzziello, Carmelina; Ruffa, Alessandra; Kohn, Anna; Vecchi, Maurizio; Guidi, Luisa; Di Mitri, Roberto; Renna, Sara; Emma, Calabrese; Rogai, Francesca; Rossi, Alessandra; Orlando, Ambrogio; Pallone, Francesco

2016-08-01

Cancer risk in inflammatory bowel disease [IBD] is still debated. In a prospective, multicentre, nested case-control study, we aimed to characterise incident cases of cancer in IBD. The role of immunomodulators vs clinical characteristics of IBD as risk factors for cancer was also investigated. From January 2012 to December 2014, each IBD patient with incident cancer was matched with two IBD patients without cancer for: IBD type, gender, and age. Risk factors were assessed by multivariate regression analysis. IBD patients considered numbered 44619: 21953 Crohn's disease [CD], 22666 ulcerative colitis [UC]. Cancer occurred in 174 patients: 99 CD [CD-K], 75 UC [UC-K]. Controls included 198 CD [CD-C], 150 UC [UC-C]. Cancer incidence in IBD was 3.9/1000, higher in CD (4.5/1000 [99/21,953]) than in UC (3.3/1000 [75/22,666]; p = 0.042). Cancers involved: digestive system [36.8%], skin [13.2%], urinary tract [12.1%], lung [8.6%], breast [8%], genital tract [6.9%], thyroid [4.6%], lymphoma [3.5%], others [6.3%]. In CD, penetrating behaviour and combined thiopurines and tumour necrosis factor alpha [TNFα] antagonists were risk factors for cancer overall: odds ratio [OR] (95% confidence interval [CI] 2.33 [1.01-5.47]); 1.97 [1.1-3.5]; and for extracolonic cancers 3.9 [1.56-10.1]; 2.15 [1.17-4.1], respectively. In UC, risk factors were pancolitis and disease-related surgery for cancer overall (OR: 2.52 [1.26-5.1]; 5.09 [1.73-17.1]); disease-related surgery for colorectal cancer [CRC] (OR 3.6 [1.0-12]); and extensive and left-sided vs distal UC for extracolonic cancers (OR: 2.55 [1.15-5.9]; 2.6 [1.04-6.6]), respectively. In a multicentre study, penetrating CD and extensive UC were risk factors for cancer overall. Cancer incidence was higher in CD than in UC. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

Science.gov (United States)

Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

2014-02-01

Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

A multicentre observational study to evaluate a new tool to assess emergency physicians' non-technical skills.

Science.gov (United States)

Flowerdew, Lynsey; Gaunt, Arran; Spedding, Jessica; Bhargava, Ajay; Brown, Ruth; Vincent, Charles; Woloshynowych, Maria

2013-06-01

To evaluate a new tool to assess emergency physicians' non-technical skills. This was a multicentre observational study using data collected at four emergency departments in England. A proportion of observations used paired observers to obtain data for inter-rater reliability. Data were also collected for test-retest reliability, observability of skills, mean ratings and dispersion of ratings for each skill, as well as a comparison of skill level between hospitals. Qualitative data described the range of non-technical skills exhibited by trainees and identified sources of rater error. 96 assessments of 43 senior trainees were completed. At a scale level, intra-class coefficients were 0.575, 0.532 and 0.419 and using mean scores were 0.824, 0.702 and 0.519. Spearman's ρ for calculating test-retest reliability was 0.70 using mean scores. All skills were observed more than 60% of the time. The skill Maintenance of Standards received the lowest mean rating (4.8 on a nine-point scale) and the highest mean was calculated for Team Building (6.0). Two skills, Supervision & Feedback and Situational Awareness-Gathering Information, had significantly different distributions of ratings across the four hospitals (ptechnical skills, especially in relation to leadership. The framework of skills may be used to identify areas for development in individual trainees, as well as guide other patient safety interventions.

Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

Science.gov (United States)

2014-01-01

Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611

Phlebitis risk varies by peripheral venous catheter site and increases after 96 hours: a large multi-centre prospective study.

Science.gov (United States)

Cicolini, Giancarlo; Manzoli, Lamberto; Simonetti, Valentina; Flacco, Maria Elena; Comparcini, Dania; Capasso, Lorenzo; Di Baldassarre, Angela; Eltaji Elfarouki, Ghaleb

2014-11-01

This multi-centre prospective field study evaluated whether peripheral venous catheter site of insertion influences the risk of catheter-related phlebitis. Potential predictors of phlebitis were also investigated. Millions of patients worldwide use peripheral venous catheters, which frequently cause local complications including phlebitis, infection and obstruction. Although phlebitis predictors have been broadly investigated, uncertainties remain on the potential effect of cannulation anatomical site, duration and the appropriate time for catheter removal. A prospective cohort design was carried out from January-June 2012. The clinical course of each patient who received a new peripheral venous catheter for any cause in five Italian hospitals was followed by trained nurses until catheter removal. The presence of phlebitis was assessed every 24 hours using the Visual Infusion Phlebitis score. Analyses were based upon multilevel mixed-effects regression. The final sample consisted of 1498 patients. The average time for catheters in situ was 65·6 hours and 23·6% of the catheters were in place beyond 96 hours. Overall phlebitis incidence was 15·4%, 94·4% of which were grade 1. The likelihood of phlebitis independently increased with increasing catheter duration, being highest after 96 hours. Compared with patients with catheter placed in the dorsum of the hand (22·8% of the sample), those with the catheter located in the antecubital fossa (34·1%) or forearm were less likely to have a phlebitis of any grade. Antecubital fossa and forearm veins may be preferential sites for peripheral venous cannulation. Our results support Centers for Disease Control and Prevention recommendations to replace catheters in adults no later than 96 hours. A relevant proportion of healthcare personnel did not adhere to such guidelines - more attention to this issue is required. © 2014 John Wiley & Sons Ltd.

Biopsy transcriptome expression profiling to identify kidney transplants at risk of chronic injury: a multicentre, prospective study

Science.gov (United States)

O’Connell, Philip J; Zhang, Weijia; Menon, Madhav C; Yi, Zhengzi; Schröppel, Bernd; Gallon, Lorenzo; Luan, Yi; Rosales, Ivy A; Ge, Yongchao; Losic, Bojan; Xi, Caixia; Woytovich, Christopher; Keung, Karen L; Wei, Chengguo; Greene, Ilana; Overbey, Jessica; Bagiella, Emilia; Najafian, Nader; Samaniego, Milagros; Djamali, Arjang; Alexander, Stephen I; Nankivell, Brian J; Chapman, Jeremy R; Smith, Rex Neal; Colvin, Robert; Murphy, Barbara

2016-01-01

Summary Background Chronic injury in kidney transplants remains a major cause of allograft loss. The aim of this study was to identify a gene set capable of predicting renal allografts at risk of progressive injury due to fibrosis. Methods This Genomics of Chronic Allograft Rejection (GoCAR) study is a prospective, multicentre study. We prospectively collected biopsies from renal allograft recipients (n=204) with stable renal function 3 months after transplantation. We used microarray analysis to investigate gene expression in 159 of these tissue samples. We aimed to identify genes that correlated with the Chronic Allograft Damage Index (CADI) score at 12 months, but not fibrosis at the time of the biopsy. We applied a penalised regression model in combination with permutation-based approach to derive an optimal gene set to predict allograft fibrosis. The GoCAR study is registered with ClinicalTrials.gov, number NCT00611702. Findings We identified a set of 13 genes that was independently predictive for the development of fibrosis at 1 year (ie, CADI-12 ≥2). The gene set had high predictive capacity (area under the curve [AUC] 0·967), which was superior to that of baseline clinical variables (AUC 0·706) and clinical and pathological variables (AUC 0·806). Furthermore routine pathological variables were unable to identify which histologically normal allografts would progress to fibrosis (AUC 0·754), whereas the predictive gene set accurately discriminated between transplants at high and low risk of progression (AUC 0·916). The 13 genes also accurately predicted early allograft loss (AUC 0·842 at 2 years and 0·844 at 3 years). We validated the predictive value of this gene set in an independent cohort from the GoCAR study (n=45, AUC 0·866) and two independent, publically available expression datasets (n=282, AUC 0·831 and n=24, AUC 0·972). Interpretation Our results suggest that this set of 13 genes could be used to identify kidney transplant recipients at

Phenotypic ASCO Characterisation of Young Patients with Ischemic Stroke in the Prospective Multicentre Observational sifap1 Study.

Science.gov (United States)

Wolf, Marc E; Grittner, Ulrike; Böttcher, Tobias; Norrving, Bo; Rolfs, Arndt; Hennerici, Michael G

2015-01-01

The prospective, multinational European 'Stroke in Young Fabry Patients' (sifap1) study collected 4,467 patients with acute ischemic cerebrovascular events aged 18-55 years. Initially, aetiologic subtyping was performed using the TOAST classification; however, recently the phenotypic ASCO classification was presented and might be more useful to identify stroke aetiologies in young patients with a wide set of different causes. ASCO is a classification system divided in four etiologic categories (Atherosclerosis, Small vessel disease (SVD), Cardiac embolism, Other cause) with different grades of severity (1-3) and aims to characterise patients in a more comprehensive way. We determined the ASCO score for each patient, according to prospectively collected data using the study protocol. The distribution of aetiologies was analysed with regard to concomitant causes, cryptogenic stroke and different age groups. A potentially causal aetiology (grade 1) was detected in 29.3% of 4,467 patients. Merging grades 1 and 2, a suspected aetiology was found in 54.1%. In 8.6% of patients concomitant aetiologies were identified. Most common causes were cervical arterial dissection and persistent foramen ovale, but there was also a high prevalence of large artery atherosclerosis and SVD especially in older patients of this collective. About 50% of patients had more than one finding with a lower grade of evidence (grade 3). In 14% final classification of strictly cryptogenic stroke was made. This is the largest study to date, using the ASCO characterisation of ischemic stroke aetiologies. ASCO classification provides first evidence that many young patients presenting with acute stroke have concomitant stroke aetiologies associated with a substantial atherosclerosis risk profile. ASCO could be integrated in clinical routine and registry data banks, as well as large clinical trials to improve stroke documentation. © 2015 S. Karger AG, Basel.

Benchmarking of surgical complications in gynaecological oncology: prospective multicentre study.

Science.gov (United States)

Burnell, M; Iyer, R; Gentry-Maharaj, A; Nordin, A; Liston, R; Manchanda, R; Das, N; Gornall, R; Beardmore-Gray, A; Hillaby, K; Leeson, S; Linder, A; Lopes, A; Meechan, D; Mould, T; Nevin, J; Olaitan, A; Rufford, B; Shanbhag, S; Thackeray, A; Wood, N; Reynolds, K; Ryan, A; Menon, U

2016-12-01

To explore the impact of risk-adjustment on surgical complication rates (CRs) for benchmarking gynaecological oncology centres. Prospective cohort study. Ten UK accredited gynaecological oncology centres. Women undergoing major surgery on a gynaecological oncology operating list. Patient co-morbidity, surgical procedures and intra-operative (IntraOp) complications were recorded contemporaneously by surgeons for 2948 major surgical procedures. Postoperative (PostOp) complications were collected from hospitals and patients. Risk-prediction models for IntraOp and PostOp complications were created using penalised (lasso) logistic regression using over 30 potential patient/surgical risk factors. Observed and risk-adjusted IntraOp and PostOp CRs for individual hospitals were calculated. Benchmarking using colour-coded funnel plots and observed-to-expected ratios was undertaken. Overall, IntraOp CR was 4.7% (95% CI 4.0-5.6) and PostOp CR was 25.7% (95% CI 23.7-28.2). The observed CRs for all hospitals were under the upper 95% control limit for both IntraOp and PostOp funnel plots. Risk-adjustment and use of observed-to-expected ratio resulted in one hospital moving to the >95-98% CI (red) band for IntraOp CRs. Use of only hospital-reported data for PostOp CRs would have resulted in one hospital being unfairly allocated to the red band. There was little concordance between IntraOp and PostOp CRs. The funnel plots and overall IntraOp (≈5%) and PostOp (≈26%) CRs could be used for benchmarking gynaecological oncology centres. Hospital benchmarking using risk-adjusted CRs allows fairer institutional comparison. IntraOp and PostOp CRs are best assessed separately. As hospital under-reporting is common for postoperative complications, use of patient-reported outcomes is important. Risk-adjusted benchmarking of surgical complications for ten UK gynaecological oncology centres allows fairer comparison. © 2016 Royal College of Obstetricians and Gynaecologists.

The EMBARC European bronchiectasis registry: Protocol for an international observational study

NARCIS (Netherlands)

Chalmers, J.D. (James D.); S. Aliberti (Stefano); Polverino, E. (Eva); Vendrell, M. (Montserrat); Crichton, M. (Megan); Loebinger, M. (Michael); Dimakou, K. (Katerina); Clifton, I. (Ian); M. van der Eerden (Menno); G. Rohde (Gernot); Murris-Espin, M. (Marlene); Masefield, S. (Sarah); Gerada, E. (Eleanor); Shteinberg, M. (Michal); F.C. Ringshausen (Felix C.); Haworth, C. (Charles); W.G. Boersma (Wim); Rademacher, J. (Jessica); Hill, A.T. (Adam T.); Aksamit, T. (Timothy); O’Donnell, A. (Anne); Morgan, L. (Lucy); B. Milenkovic (Branislava); Tramma, L. (Leandro); Neves, J. (Joao); Menendez, R. (Rosario); Paggiaro, P. (Perluigi); Botnaru, V. (Victor); Skrgat, S. (Sabina); R. Wilson (Richard); Goeminne, P. (Pieter); De Soyza, A. (Anthony); T. Welte; Torres, A. (Antoni); S. Elborn (Stuart); Blasi, F. (Francesco)

2016-01-01

textabstractBronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration) registry is a prospective,

Automatic segmentation of male pelvic anatomy on computed tomography images: a comparison with multiple observers in the context of a multicentre clinical trial

International Nuclear Information System (INIS)

Geraghty, John P; Grogan, Garry; Ebert, Martin A

2013-01-01

This study investigates the variation in segmentation of several pelvic anatomical structures on computed tomography (CT) between multiple observers and a commercial automatic segmentation method, in the context of quality assurance and evaluation during a multicentre clinical trial. CT scans of two prostate cancer patients (‘benchmarking cases’), one high risk (HR) and one intermediate risk (IR), were sent to multiple radiotherapy centres for segmentation of prostate, rectum and bladder structures according to the TROG 03.04 “RADAR” trial protocol definitions. The same structures were automatically segmented using iPlan software for the same two patients, allowing structures defined by automatic segmentation to be quantitatively compared with those defined by multiple observers. A sample of twenty trial patient datasets were also used to automatically generate anatomical structures for quantitative comparison with structures defined by individual observers for the same datasets. There was considerable agreement amongst all observers and automatic segmentation of the benchmarking cases for bladder (mean spatial variations < 0.4 cm across the majority of image slices). Although there was some variation in interpretation of the superior-inferior (cranio-caudal) extent of rectum, human-observer contours were typically within a mean 0.6 cm of automatically-defined contours. Prostate structures were more consistent for the HR case than the IR case with all human observers segmenting a prostate with considerably more volume (mean +113.3%) than that automatically segmented. Similar results were seen across the twenty sample datasets, with disagreement between iPlan and observers dominant at the prostatic apex and superior part of the rectum, which is consistent with observations made during quality assurance reviews during the trial. This study has demonstrated quantitative analysis for comparison of multi-observer segmentation studies. For automatic segmentation

Multicentric primary extramammary Paget disease: a Toker cell disorder?

Science.gov (United States)

Hashemi, Pantea; Kao, Grace F; Konia, Thomas; Kauffman, Lisa C; Tam, Christine C; Sina, Bahram

2014-07-01

Toker cells are epithelial clear cells found in the areolar and nipple areas of the breast, vulvar region, and other apocrine gland-bearing areas of the skin. Toker cells have been implicated in the pathogenesis of clear cell papulosis, cutaneous hamartoma with pagetoid cells, and rare cases of primary extramammary Paget disease (EMPD) but not in secondary EMPD with underlying adenocarcinoma. The pathogenesis of primary EMPD is not well defined. We report a case of multicentric primary EMPD with evidence of Toker cell proliferation and nonaggressive biologic behavior in a 63-year-old white man. A detailed description of the morphologic and biologic features of Toker cells and their possible carcinogenetic links also are discussed. Based on the observation and follow-up of our patient, we hypothesize that multicentric primary EMPD starts with Toker cell hyperplasia and can potentially evolve to carcinoma in the genital region.

A multicentre prospective study of Guillain-Barré syndrome in Japan: a focus on the incidence of subtypes.

Science.gov (United States)

Mitsui, Yoshiyuki; Kusunoki, Susumu; Arimura, Kimiyoshi; Kaji, Ryuji; Kanda, Takashi; Kuwabara, Satoshi; Sonoo, Masahiro; Takada, Kazuo

2015-01-01

Guillain-Barré Syndrome (GBS) is classified into the two major subtypes; acute inflammatory demyelinating polyneuropathy (AIDP) and acute motor axonal neuropathy (AMAN). Previous studies have suggested that AIDP is predominant and AMAN is rare in Western countries, whereas AMAN is not always uncommon in East Asia. We aimed to clarify the incidence of the subtypes of GBS in Japan. We performed a prospective multicentre survey over 3 years (2007-2010). Clinical and electrophysiological findings were collected from 184 patients with GBS in 23 tertiary neurology institutes. Anti-ganglioside antibodies were measured by ELISA. We also surveyed the incidence of Fisher syndrome (FS). By electrodiagnostic criteria of Ho et al, patients were classified as having AIDP (40%), or AMAN (22%), or unclassified (38%). Anti-GM1 IgG antibodies were found for 47% of AMAN patients, and 18% of AIDP patients (p<0.001). There were no specific regional trends of the electrodiagnosis and anti-GM1 positivity. During the same study period, 79 patients with FS were identified; the percentage of FS cases out of all cases (FS/(GBS+FS)) was 26%. The frequency of GBS patients with the electrodiagnosis of AMAN by single nerve conduction studies is approximately 20% in Japan, and the AMAN pattern is closely associated with anti-GM1 antibodies. The incidence of FS appears to be much higher in Japan than in Western countries. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

18F-FDG PET/CT in the characterization and surgical decision concerning adrenal masses: a prospective multicentre evaluation

International Nuclear Information System (INIS)

Ansquer, Catherine; Scigliano, Sonia; Mirallie, Eric; Taieb, David; Brunaud, Laurent; Sebag, Frederic; Leux, Christophe; Drui, Delphine; Dupas, Benoit; Renaudin, Karine; Kraeber-Bodere, Francoise

2010-01-01

This prospective multicentre study assesses the usefulness of FDG PET/CT in characterizing and making the therapeutic decision concerning adrenal tumours that are suspicious or indeterminate in nature after conventional examinations (CE). Seventy-eight patients (37 men, 41 women, 81 adrenal lesions) underwent FDG PET/CT after CE including CT scan, biological tests and optionally 131 I-metaiodobenzylguanidine (MIBG) and/or 131 I-norcholesterol scans. FDG adrenal uptake exceeding that of the liver was considered positive. PET results were not decisive. Surgery was discussed when at least one of the following criteria was found during CE: size >3 cm, spontaneous attenuation value >10 HU, heterogeneous aspect, abnormal MIBG or norcholesterol scan or hormonal hypersecretion. Following the gold standard (histology analysis or ≥9 months follow-up), 49 lesions potentially qualified for surgery (malignant = 27, benign secreting = 22) and 32 benign non-secreting lesions did not. PET was negative in 97% of non-surgical lesions and positive in 73% of potentially surgical ones which included all the malignant lesions, except 3 renal cell metastases, and 12 of 22 benign secreting lesions. The negative predictive value for malignancy was 93% (41/44) and positive predictive value for detecting surgical lesions was 97% (36/37). A high FDG uptake (maximum standardized uptake value ≥ 10) was highly predictive of malignancy. Adrenal FDG uptake is a good indicator of malignancy and/or of secreting lesions and should lead one to discuss surgery. If there is no prior history of poorly FDG-avid cancer, the absence of FDG uptake should avoid unnecessary removal of benign adrenal lesions. (orig.)

Feasibility and cost efficiency of a diagnostic guideline for chronic polyneuropathy : a prospective implementation study

NARCIS (Netherlands)

Vrancken, A.F.J.E.; Kalmijn, S.; Buskens, E.; Franssen, H.; Wokke, J.H.J.; Notermans, N.C.

2006-01-01

Background: Extensive investigations are often performed to reveal the cause of chronic polyneuropathy. It is not known whether a restrictive diagnostic guideline improves cost efficiency without loss of diagnostic reliability. Methods: In a prospective multicentre study, a comparison was made

The effectiveness of 2-implant overdentures: a pragmatic international multicentre study

NARCIS (Netherlands)

Rashid, F.; Awad, M.A.; Thomason, J.M.; Piovano, A.; Spielberg, G.P.; Scilingo, E.; Mojon, P.; Müller, F.; Spielberg, M.; Heydecke, G.; Stoker, G.; Wismeijer, D.; Allen, F.; Feine, J.S.

2011-01-01

The purpose of this multicentre observational study was to determine patient satisfaction with either conventional dentures or mandibular 2-implant overdentures in a 'real world' setting. Two hundred and three edentulous patients (mean age 68·8 ± 10·4 years) were recruited at eight centres located

Laparoscopic excision of deep rectovaginal endometriosis in BSGE endometriosis centres: a multicentre prospective cohort study

Science.gov (United States)

Byrne, Dominic; Curnow, Tamara; Smith, Paul; Cutner, Alfred; Saridogan, Ertan; Clark, T Justin

2018-01-01

Objective To estimate the effectiveness and safety of laparoscopic surgical excision of rectovaginal endometriosis. Design A multicentre, prospective cohort study. Setting 51 hospitals accredited as specialist endometriosis centres. Participants 5162 women of reproductive age with rectovaginal endometriosis of which 4721 women had planned laparoscopic excision. Interventions Laparoscopic surgical excision of rectovaginal endometriosis requiring dissection of the pararectal space. Main outcome measures Standardised symptom questionnaires enquiring about chronic pelvic pain, bladder and bowel symptoms, analgesia use and quality of life (EuroQol) completed prior to surgery and at 6, 12 and 24 months postoperatively. Serious perioperative and postoperative complications including major haemorrhage, infection and visceral injury were recorded. Results At 6 months postsurgery, there were significant reductions in premenstrual, menstrual and non-cyclical pelvic pain, deep dyspareunia, dyschezia, low back pain and bladder pain. In addition, there were significant reductions in voiding difficulty, bowel frequency, urgency, incomplete emptying, constipation and passing blood. These reductions were maintained at 2 years, with the exception of voiding difficulty. Global quality of life significantly improved from a median pretreatment score of 55/100 to 80/100 at 6 months. There was a significant improvement in quality of life in all measured domains and in quality-adjusted life years. These improvements were sustained at 2 years. All analgesia use was reduced and, in particular, opiate use fell from 28.1% prior to surgery to 16.1% at 6 months. The overall incidence of complications was 6.8% (321/4721). Gastrointestinal complications (enterotomy, anastomotic leak or fistula) occurred in 52 (1.1%) operations and of the urinary tract (ureteric/bladder injury or leak) in 49 (1.0%) procedures. Conclusion Laparoscopic surgical excision of rectovaginal endometriosis

Feasibility and cost efficiency of a diagnostic guideline for chronic polyneuropathy: a prospective implementation study

NARCIS (Netherlands)

Vrancken, A. F. J. E.; Kalmijn, S.; Buskens, E.; Franssen, H.; Vermeulen, M.; Wokke, J. H. J.; Notermans, N. C.

2006-01-01

Extensive investigations are often performed to reveal the cause of chronic polyneuropathy. It is not known whether a restrictive diagnostic guideline improves cost efficiency without loss of diagnostic reliability. In a prospective multicentre study, a comparison was made between the workup in

The impact of PET-CT in suspected recurrent ovarian cancer: A prospective multi-centre study as part of the Australian PET Data Collection Project.

Science.gov (United States)

Fulham, M J; Carter, J; Baldey, A; Hicks, R J; Ramshaw, J E; Gibson, M

2009-03-01

To assess the impact of FDG PET-CT on the management of patients with suspected recurrent ovarian cancer and to determine the incremental information provided by PET-CT. This was a prospective, multi-centre, cohort study. Ninety women (mean age 59.9 years; age range 35-85 years) with a previous history of treated epithelial ovarian carcinoma and suspected recurrence based on elevated CA-125, anatomical imaging or clinical symptoms were studied with FDG PET-CT across two States. Referring doctors were asked to specify a management plan pre-PET, if management was altered after PET-CT and, the impact (rated - none, low, medium, high) of PET-CT on patient management. The pre-PET management plan could include radiotherapy, chemotherapy, surgery, and 'other' including observation. Patients were followed at 6 and 12 months and clinical status, evidence of recurrence and progression were recorded. Patients were referred by 34 individual specialists. At least 168 additional sites of disease in 61 patients (68%), not identified by conventional imaging were identified by PET-CT. In 77% the additional lesions were located below the diaphragm and most were nodal or peritoneal. PET-CT affected management in 60% (49% high, 11% medium impact). Patients where more disease was detected with PET-CT were more likely to progress in the following 12 months. For women with previously treated ovarian carcinoma with recurrent disease, PET-CT can: a) alter management in close to 60% of patients, b) detect more sites of disease than abdominal and pelvic CT, c) is superior in the detection of nodal, peritoneal and subcapsular liver disease and d) offers the opportunity for technology replacement in this setting.

Questing for circadian dependence in ST-segment-elevation acute myocardial infarction: A multicentric and multiethnic study

KAUST Repository

Ammirati, Enrico

2013-05-09

Rationale: Four monocentric studies reported that circadian rhythms can affect left ventricular infarct size after ST-segment-elevation acute myocardial infarction (STEMI). Objective: To further validate the circadian dependence of infarct size after STEMI in a multicentric and multiethnic population. Methods and Results: We analyzed a prospective cohort of subjects with first STEMI from the First Acute Myocardial Infarction study that enrolled 1099 patients (ischemic time <6 hours) in Italy, Scotland, and China. We confirmed a circadian variation of STEMI incidence with an increased morning incidence (from 6:00 am till noon). We investigated the presence of circadian dependence of infarct size plotting the peak creatine kinase against time onset of ischemia. In addition, we studied the patients from the 3 countries separately, including 624 Italians; all patients were treated with percutaneous coronary intervention. We adopted several levels of analysis with different inclusion criteria consistent with previous studies. In all the analyses, we did not find a clear-cut circadian dependence of infarct size after STEMI. Conclusions: Although the circadian dependence of infarct size supported by previous studies poses an intriguing hypothesis, we were unable to converge toward their conclusions in a multicentric and multiethnic setting. Parameters that vary as a function of latitude could potentially obscure the circadian variations observed in monocentric studies. We believe that, to assess whether circadian rhythms can affect the infarct size, future study design should not only include larger samples but also aim to untangle the molecular time-dynamic mechanisms underlying such a relation. © 2013 American Heart Association, Inc.

Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications.

Science.gov (United States)

Schmidt, Arthur; Beyna, Torsten; Schumacher, Brigitte; Meining, Alexander; Richter-Schrag, Hans-Juergen; Messmann, Helmut; Neuhaus, Horst; Albers, David; Birk, Michael; Thimme, Robert; Probst, Andreas; Faehndrich, Martin; Frieling, Thomas; Goetz, Martin; Riecken, Bettina; Caca, Karel

2017-08-10

Endoscopic full-thickness resection (EFTR) is a novel treatment of colorectal lesions not amenable to conventional endoscopic resection. The aim of this prospective multicentre study was to assess the efficacy and safety of the full-thickness resection device. 181 patients were recruited in 9 centres with the indication of difficult adenomas (non-lifting and/or at difficult locations), early cancers and subepithelial tumours (SET). Primary endpoint was complete en bloc and R0 resection. EFTR was technically successful in 89.5%, R0 resection rate was 76.9%. In 127 patients with difficult adenomas and benign histology, R0 resection rate was 77.7%. In 14 cases, lesions harboured unsuspected cancer, another 15 lesions were primarily known as cancers. Of these 29 cases, R0 resection was achieved in 72.4%; 8 further cases had deep submucosal infiltration >1000 µm. Therefore, curative resection could only be achieved in 13/29 (44.8%). In the subgroup with SET (n=23), R0 resection rate was 87.0%. In general, R0 resection rate was higher with lesions ≤2 cm vs >2 cm (81.2% vs 58.1%, p=0.0038). Adverse event rate was 9.9% with a 2.2% rate of emergency surgery. Three-month follow-up was available from 154 cases and recurrent/residual tumour was evident in 15.3%. EFTR has a reasonable technical efficacy especially in lesions ≤2 cm with acceptable complication rates. Curative resection rate for early cancers was too low to recommend its primary use in this indication. Further comparative studies have to show the clinical value and long-term outcome of EFTR in benign colorectal lesions. NCT02362126; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[Multicentre, prospective cohort study, to validate the Italian version of the Braden Q scale for the risk of the pressure sores in newborns and up to 8 years old children].

Science.gov (United States)

Chiari, Paolo; Poli, Marco; Magli, Claudia; Bascelli, Emanuele; Rocchi, Roberto; Bolognini, Silvia; Tartari, Piero; Armuzzi, Roberta; Rossi, Gianna; Peghetti, Angela; Biavati, Catia; Fontana, Mirella; Gazineo, Domenica; Cordella, Simona; Tiozzo, Emanuela; Ciliento, Gaetano; Carta, Giovanna; Taddia, Patrizia

2012-01-01

Multicenter prospective cohort study, to validate the Italian version of the Braden Q scale for the risk of pressure sores in newborns and up to 8 years old children. Children admitted to Intensive care Units (ICU), oncology and neurology/neurosurgery wards are at risk of developing pressure sores. To validate the Italian version of the Braden Q scale for the assessment of the risk of developing pressure sores in children. Children from 21 days to 8 years, admitted to intensive and sub intensive units were recruited. Premature babies, children admitted with a pressure sore and with a story of congenital cardiomiopathy were excluded. In this cohort, multicentre and with repeated measurements study, the first assessment was performed after 24 hours from hospital admission, using the Braden Q Scale (Suddaby's version). The pressure sores were assessed with the Skin assessment Tool and staged according to the National Pressure Ulcer Advisory Panel. RESULTS. On the 157 children 524 observation were conducted. The incidence of pressure sores was 17.2%. Only the analysis on specific subgroups of patients showed a good diagnostic accuracy: 71.4% on children 3-8 years; 85.6% in sub intensive wards. The Braden Q scale may be reliably used and shows a good diagnostic accuracy in children 3-8 years of age admitted to sub-intensive, neurology, oncology and heamatology wards.

Effectiveness and tolerability of fixed-dose combination enalapril plus nitrendipine in hypertensive patients: results of the 3-month observational, post-marketing, multicentre, prospective CENIT study.

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Sierra, Alejandro de la; Roca-Cusachs, Alejandro; Redón, Josep; Marín, Rafael; Luque, Manuel; Figuera, Mariano de la; Garcia-Garcia, Margarida; Falkon, Liliana

2009-01-01

Monotherapy with any class of antihypertensive drug effectively controls blood pressure (BP) in only about 50% of patients. Consequently, the majority of patients with hypertension require combined therapy with two or more medications. This study aimed to evaluate the effectiveness (systolic BP [SBP]/diastolic BP [DBP] control) and tolerability of the fixed-dose combination enalapril/nitrendipine 10 mg/20 mg administered as a single daily dose in hypertensive patients. This was a post-authorization, multicentre, prospective, observational study conducted in primary care with a 3-month follow-up. Patients throughout Spain with uncontrolled hypertension (> or =140/90 mmHg for patients without diabetes mellitus, or > or =130/85 mmHg for patients with diabetes) on monotherapy or with any combination other than enalapril + nitrendipine, or who were unable to tolerate their previous antihypertensive therapy, were recruited. Change from previous to study treatment was according to usual clinical practice. BP was measured once after 5 minutes of rest in the sitting position. Therapeutic response was defined as follows: 'controlled' meant controlled BP ( or =20 mmHg and in DBP of > or =10 mmHg. The main laboratory test parameters were documented at baseline and after 3 months. Patients aged >65 years, with diabetes, with isolated systolic hypertension (ISH; SBP > or =140 mmHg for patients without diabetes, SBP > or =130 mmHg for patients with diabetes) and who were obese (body mass index [BMI] > or =30 kg/m2) were analysed separately. Of 6537 patients included, 5010 and 6354 patients were assessed in effectiveness and tolerability analyses, respectively. In the tolerability analysis population, there were 3023 men (47.6%) and 3321 women (52.4%). The mean (+/- SD) age of the tolerability analysis group was 62.8 (+/- 10.7) years. A total of 71.1% of the patients presented at least one clinical cardiovascular risk factor other than hypertension, with the most frequent being

Functional independence and health-related functional status following spinal cord injury : a prospective study of the association with physical capacity

NARCIS (Netherlands)

Haisma, Janneke A.; Post, Marcel W.; van der Woude, Lucas H.; Stam, Henk J.; Bergen, Michael P.; Sluis, Tebbe A.; van den Berg-Emons, Hendrika J.; Bussmann, Johannes B.

2008-01-01

Objective: To determine changes in functional independence following spinal cord injury and to evaluate the association between functional independence and physical capacity. Design: Multi-centre prospective cohort study. Subjects: Patients with spinal cord injury admitted for initial

Chronic pancreatitis: Multicentre prospective data collection and analysis by the Hungarian Pancreatic Study Group.

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Ákos Szücs

Full Text Available Chronic pancreatitis is an inflammatory disease associated with structural and functional damage to the pancreas, causing pain, maldigestion and weight loss and thus worsening the quality of life.Our aim was to find correlations from a multicentre database representing the epidemiological traits, diagnosis and treatment of the disease in Hungary. The Hungarian Pancreatic Study Group collected data prospectively from 2012 to 2014 on patients suffering from chronic pancreatitis. Statistical analysis was performed on different questions.Data on 229 patients (74% male and 26% female were uploaded from 14 centres. Daily alcohol consumption was present in the aetiology of 56% of the patients. 66% of the patients were previously treated for acute exacerbation. One third of the patients had had previous endoscopic or surgical interventions. Pain was present in 69% of the cases, endocrine insufficiency in 33%, diarrhoea in 13% and weight loss in 39%. Diagnosis was confirmed with US (80%, CT scan (52%, MRI-MRCP (6%, ERCP (39%, and EUS (7,4%. A functional test was carried out in 5% of the patients. In 31% of the cases, an endoscopic intervention was performed with the need for re-intervention in 5%. Further elective surgical intervention was necessitated in 44% of endoscopies. 20% of the registered patients were primarily treated with surgery. The biliary complication rate for surgery was significantly smaller (2% than endoscopy (27%; however, pancreatic complications were higher in the patients treated with surgery. Patients who smoked regularly needed significantly more surgical intervention following endoscopy (66.7% vs. 26.9%, p = 0.002 than non-smokers, and the ratio of surgical intervention alone was also significantly higher (27.3% vs. 10.8%, p = 0.004. The ratio of surgery in patients who smoked and drank was significantly higher (30.09% vs. 12.5%, p = 0.012 than in abstinent and non-smoking patients, similarly to the need for further surgical

Chronic pancreatitis: Multicentre prospective data collection and analysis by the Hungarian Pancreatic Study Group.

Science.gov (United States)

Szücs, Ákos; Marjai, Tamás; Szentesi, Andrea; Farkas, Nelli; Párniczky, Andrea; Nagy, György; Kui, Balázs; Takács, Tamás; Czakó, László; Szepes, Zoltán; Németh, Balázs Csaba; Vincze, Áron; Pár, Gabriella; Szabó, Imre; Sarlós, Patrícia; Illés, Anita; Gódi, Szilárd; Izbéki, Ferenc; Gervain, Judit; Halász, Adrienn; Farkas, Gyula; Leindler, László; Kelemen, Dezső; Papp, Róbert; Szmola, Richárd; Varga, Márta; Hamvas, József; Novák, János; Bod, Barnabás; Sahin-Tóth, Miklós; Hegyi, Péter

2017-01-01

Chronic pancreatitis is an inflammatory disease associated with structural and functional damage to the pancreas, causing pain, maldigestion and weight loss and thus worsening the quality of life. Our aim was to find correlations from a multicentre database representing the epidemiological traits, diagnosis and treatment of the disease in Hungary. The Hungarian Pancreatic Study Group collected data prospectively from 2012 to 2014 on patients suffering from chronic pancreatitis. Statistical analysis was performed on different questions. Data on 229 patients (74% male and 26% female) were uploaded from 14 centres. Daily alcohol consumption was present in the aetiology of 56% of the patients. 66% of the patients were previously treated for acute exacerbation. One third of the patients had had previous endoscopic or surgical interventions. Pain was present in 69% of the cases, endocrine insufficiency in 33%, diarrhoea in 13% and weight loss in 39%. Diagnosis was confirmed with US (80%), CT scan (52%), MRI-MRCP (6%), ERCP (39%), and EUS (7,4%). A functional test was carried out in 5% of the patients. In 31% of the cases, an endoscopic intervention was performed with the need for re-intervention in 5%. Further elective surgical intervention was necessitated in 44% of endoscopies. 20% of the registered patients were primarily treated with surgery. The biliary complication rate for surgery was significantly smaller (2%) than endoscopy (27%); however, pancreatic complications were higher in the patients treated with surgery. Patients who smoked regularly needed significantly more surgical intervention following endoscopy (66.7% vs. 26.9%, p = 0.002) than non-smokers, and the ratio of surgical intervention alone was also significantly higher (27.3% vs. 10.8%, p = 0.004). The ratio of surgery in patients who smoked and drank was significantly higher (30.09% vs. 12.5%, p = 0.012) than in abstinent and non-smoking patients, similarly to the need for further surgical

A prospective observational trial on emesis in radiotherapy: Analysis of 1020 patients recruited in 45 Italian radiation oncology centres

International Nuclear Information System (INIS)

Maranzano, Ernesto; De Angelis, Verena; Pergolizzi, Stefano; Lupattelli, Marco; Frata, Paolo; Spagnesi, Stefano; Frisio, Maria Luisa; Mandoliti, Giovanni; Malinverni, Giuseppe; Trippa, Fabio; Fabbietti, Letizia; Parisi, Salvatore; Di Palma, Annamaria; De Vecchi, Pietro; De Renzis, Costantino; Giorgetti, Celestino; Bergami, Tiziano; Orecchia, Roberto; Portaluri, Maurizio; Signor, Marco

2010-01-01

Purpose: A prospective observational multicentre trial was carried out to assess the incidence, pattern, and prognostic factors of radiation-induced emesis (RIE), and to evaluate the use of antiemetic drugs in patients treated with radiotherapy or concomitant radio-chemotherapy. The application in clinical practice of the Multinational Association of Supportive Care in Cancer guidelines was also studied. Materials and methods: Forty-five Italian radiation oncology centres took part in this trial. The accrual lasted for 3 consecutive weeks and only patients starting radiotherapy or concomitant radio-chemotherapy in this period were enrolled. Evaluation was based on diary card filled in daily by patients during treatment and one week after stopping it. Diary card recorded the intensity of nausea/vomiting and prophylactic/symptomatic antiemetic drug prescriptions. Results: A total of 1020 patients entered into the trial, and 1004 were evaluable. Vomiting and nausea occurred in 11.0% and 27.1% of patients, respectively, and 27.9% patients had both vomiting and nausea. In multifactorial analysis, the only statistically significant patient-related risk factors were concomitant chemotherapy and previous experience of vomiting induced by chemotherapy. Moreover, two radiotherapy-related factors were significant risk factors for RIE, the irradiated site (upper abdomen) and field size (>400 cm 2 ). An antiemetic drug was given only to a minority (17%) of patients receiving RT, and the prescriptions were prophylactic in 12.4% and symptomatic in 4.6%. Different compounds and a wide range of doses and schedules were used. Conclusions: These data were similar to those registered in our previous observational trial, and the radiation oncologists' attitude in underestimating RIE and under prescribing antiemetics was confirmed.

Mygale lasiodora: A multicentric observational homoeopathic clinical verification study

Directory of Open Access Journals (Sweden)

Raj K Manchanda

2015-01-01

Conclusions: Total 34 available symptoms were verified, and 47 new symptoms were identified. Cautious interpretation is necessary. Further replication on larger sample and estimation of likelihood ratio, in general, practice settings in prospective Bayesian approach is necessary before inclusion of the symptoms in homoeopathic literature.

[Candidemias: multicentre analysis in 16 hospitals in Andalusia (Spain)].

Science.gov (United States)

Rodríguez-Hernández, M Jesús; Ruiz-Pérez de Pipaon, Maite; Márquez-Solero, Manuel; Martín-Rico, Patricia; Castón-Osorio, Juan José; Guerrero-Sánchez, Francisca M; Vidal-Verdú, Elisa; García-Figueras, Carolina; Del Arco-Jiménez, Alfonso; Rodríguez-Baño, Jesús; Martín-Mazuelos, Estrella; Cisneros-Herreros, José Miguel

2011-05-01

Candidemia is a nosocomial infection with high associated mortality. There have been changes in microbiology, epidemiology and treatment over the last few years, which has led us to analyse our own situation. Prospective, multicentre and observational study. All episodes of candidemia in adult patients seen in 17 Andalusian hospitals from 1 October 2005 to 30 September 2006 were included. Were detected 220 cases, the incidence was 0.58 cases/1,000 hospital discharges. Candida albicans was the most frecuent species (53% of cases). The majority of isolates (89%) was susceptibility to fluconazole. Sepsis was the most frequent clinical manifestation (65.7%). The treatment was inadequate in 38.7% of cases. Overall mortality was 40%. On univarite analysis death was found to be significantly associated with: aged > 60 years, unknown candidemia focus, Pitt score ≥ 2, APACHE II, shock at onset, persistents positive second blood cultures, non-removal of the central venous catheter and Candida species different of C. parasilopsis, among others. In the multivariate analysis death was found to be significantly associated with: aged > 60 years, Pitt score ≥ 2, Candida species different of C.parasilopsis and inadequate treatment. The candidemia clinical epidemiology in our region is similar to other areas and receiving inadequate treatment is the only modifiable risk factor associated with higher odds of mortality. Therefore, this modifiable factor needs to be improved to reduce the mortality. Copyright © 2010 Elsevier España, S.L. All rights reserved.

Colorectal cancer and its association with the metabolic syndrome: a Malaysian multi-centric case-control study.

Science.gov (United States)

Ulaganathan, V; Kandiah, M; Zalilah, M S; Faizal, J A; Fijeraid, H; Normayah, K; Gooi, B H; Othman, R

2012-01-01

Colorectal cancer (CRC) and the metabolic syndrome (MetS) are both on the rise in Malaysia. A multi-centric case-control study was conducted from December 2009 to January 2011 to determine any relationship between the two. Patients with confirmed CRC based on colonoscopy findings and cancer free controls from five local hospitals were assessed for MetS according to the International Diabetes Federation (IDF) definition. Each index case was matched for age, gender and ethnicity with two controls (140: 280). MetS among cases was highly prevalent (70.7%), especially among women (68.7%). MetS as an entity increased CRC risk by almost three fold independently (OR=2.61, 95%CI=1.53-4.47). In men MetS increased the risk of CRC by two fold (OR=2.01, 95%CI, 1.43-4.56), demonstrating an increasing trend in risk with the number of Mets components observed. This study provides evidence for a positive association between the metabolic syndrome and colorectal cancer. A prospective study on the Malaysian population is a high priority to confirm these findings.

Time-courses of lung function and respiratory muscle pressure generating capacity after spinal cord injury : a prospective cohort study

NARCIS (Netherlands)

Mueller, Gabi; de Groot, Sonja; van der Woude, Lucas; Hopman, Maria T E

OBJECTIVE: To investigate the time-courses of lung function and respiratory muscle pressure generating capacity after spinal cord injury. DESIGN: Multi-centre, prospective cohort study. SUBJECTS: One hundred and nine subjects with recent, motor complete spinal cord injury. METHODS: Lung function and

FDG PET during radiochemotherapy is predictive of outcome at 1 year in non-small-cell lung cancer patients: a prospective multicentre study (RTEP2)

International Nuclear Information System (INIS)

Vera, Pierre; Edet-Sanson, Agathe; Modzelewski, Romain; Mezzani-Saillard, Sandrine; Thureau, Sebastien; Dubray, Bernard; Menard, Jean-Francois; Meyer, Marc-Etienne; Jalali, Khadija; Bardet, Stephane; Lerouge, Delphine; Houzard, Claire; Mornex, Francoise; Olivier, Pierre; Faure, Guillaume; Rousseau, Caroline; Mahe, Marc-Andre; Gomez, Philippe; Brenot-Rossi, Isabelle; Salem, Naji

2014-01-01

To assess prospectively the prognostic value of FDG PET/CT during curative-intent radiotherapy (RT) with or without concomitant chemotherapy in patients with non-small-cell lung cancer (NSCLC). Patients with histological proof of invasive localized NSCLC and evaluable tumour, and who were candidates for curative-intent radiochemotherapy (RCT) or RT were preincluded after providing written informed consent. Definitive inclusion was conditional upon significant FDG uptake before RT (PET 1 ). All included patients had a FDG PET/CT scan during RT (PET 2 , mean dose 43 Gy) and were evaluated by FDG PET/CT at 3 months and 1 year after RT. The main endpoint was death (from whatever cause) or tumour progression at 1 year. Of 77 patients preincluded, 52 were evaluable. Among the evaluable patients, 77 % received RT with induction chemotherapy and 73 % RT with concomitant chemotherapy. At 1 year, 40 patients (77 %) had died or had tumour progression. No statistically significant association was found between stage (IIIB vs. other), histology (squamous cell carcinoma vs. other), induction or concomitant chemotherapy, and death/tumour progression at 1 year. The SUV max in the PET 2 scan was the single variable predictive of death or tumour progression at 1 year (odds ratio 1.97, 95 % CI 1.25 - 3.09, p = 0.003) in multivariate analysis. The area under the receiver operating characteristic curve was 0.85 (95 % CI 0.73 - 0.94, p -4 ). A SUV max value of 5.3 in the PET 2 scan yielded a sensitivity of 70 % and a specificity of 92 % for predicting tumour progression or death at 1 year. This prospective multicentre study demonstrated the prognostic value in terms of disease-free survival of SUV max assessed during the 5th week of curative-intent RT or RCT in NSCLC patients (NCT01261598; RTEP2 study). (orig.)

Protocol for a multicentre, prospective, population-based cohort study of variation in practice of cholecystectomy and surgical outcomes (The CholeS study).

Science.gov (United States)

Vohra, Ravinder S; Spreadborough, Philip; Johnstone, Marianne; Marriott, Paul; Bhangu, Aneel; Alderson, Derek; Morton, Dion G; Griffiths, Ewen A

2015-01-12

Cholecystectomy is one of the most common general surgical operations performed. Despite level one evidence supporting the role of cholecystectomy in the management of specific gallbladder diseases, practice varies between surgeons and hospitals. It is unknown whether these variations account for the differences in surgical outcomes seen in population-level retrospective data sets. This study aims to investigate surgical outcomes following acute, elective and delayed cholecystectomies in a multicentre, contemporary, prospective, population-based cohort. UK and Irish hospitals performing cholecystectomies will be recruited utilising trainee-led research collaboratives. Two months of consecutive, adult patient data will be included. The primary outcome measure of all-cause 30-day readmission rate will be used in this study. Thirty-day complication rates, bile leak rate, common bile duct injury, conversion to open surgery, duration of surgery and length of stay will be measured as secondary outcomes. Prospective data on over 8000 procedures is anticipated. Individual hospitals will be surveyed to determine local policies and service provision. Variations in outcomes will be investigated using regression modelling to adjust for confounders. Research ethics approval is not required for this study and has been confirmed by the online National Research Ethics Service (NRES) decision tool. This novel study will investigate how hospital-level surgical provision can affect patient outcomes, using a cross-sectional methodology. The results are essential to inform commissioning groups and implement changes within the National Health Service (NHS). Dissemination of the study protocol is primarily through the trainee-led research collaboratives and the Association of Upper Gastrointestinal Surgeons (AUGIS). Individual centres will have access to their own results and the collective results of the study will be published in peer-reviewed journals and presented at relevant

Diet and Pre-eclampsia: A Prospective Multicentre Case-Control Study in Ethiopia.

Science.gov (United States)

Endeshaw, Mulualem; Abebe, Fantu; Bedimo, Melkamu; Asart, Anemaw

2015-06-01

Pre-eclampsia is one of the most commonly encountered hypertensive disorders of pregnancy that accounts for 20-80% of maternal mortality in developing countries, including Ethiopia. For many years, diet has been suggested to play a role in pre-eclampsia. However, the hypotheses have been diverse with inconsistent results across studies, and this has not been studied in Ethiopia. The objective of this study was to determine the effect of dietary habits on the incidence of pre-eclampsia in Bahir Dar, Ethiopia A prospective multicentre unmatched case-control study was conducted among 453 (151 cases and 302 controls) pregnant women attending antepartum or intrapartum care in public health facilities of Bahir Dar City from June to September 2014. The interviewer conducted a face-to-face interview, measured the mid-upper arm circumference (MUAC) and collected the mid-pregnancy haemoglobin level from clinical notes using a standardized and pretested questionnaire. Epi Info 3.5.3 was used for data entry and cleaning, while IBM SPSS Statistics 20 was used for data analysis. Backward stepwise unconditional logistic regression analysis was employed to determine the strength of association of predictive variables with the outcome variable and to control for the effect of confounding variables. A P-value ≤0.05 was considered statistically significant. For every 1-cm increase of MUAC, there was an increase in the incidence rate of pre-eclampsia by a factor of 1.35 (adjusted odds ratio (AOR)=1.35, 95% confidence interval (CI): 1.21, 1.51). A higher incidence of pre-eclampsia was found in women who reported to have consumed coffee daily during pregnancy (AOR=1.78, 95% CI: 1.20, 3.05). Similarly, for women who had anaemia during the first trimester, the incidence of pre-eclampsia was 2.5 times higher than their counterparts (AOR=2.47, 95% CI: 1.12, 7.61). This study also revealed consumption of fruit or vegetables at least three times a week during pregnancy to be protective

The prognostic value of pimonidazole and tumour pO2 in human cervix carcinomas after radiation therapy: a prospective international multi-center study

DEFF Research Database (Denmark)

Nordsmark, Marianne; Loncaster, Julie; Aquino-Parsons, Christina

2006-01-01

BACKGROUND AND PURPOSE: Hypoxia adversely affects treatment outcome in human uterine cervical cancer. Here, we present the results of a prospective international multi-centre study evaluating the prognostic value of pre-treatment tumour oxygen partial pressure (pO(2)) and the hypoxia marker pimon...... pimonidazole (pimo). MATERIALS AND METHODS: One hundred and twenty-seven patients with primary cervix cancer were entered. Pre-treatment tumour pO(2) measurements were obtained, and reported by the median tumour pO(2), the fraction of pO(2) values......BACKGROUND AND PURPOSE: Hypoxia adversely affects treatment outcome in human uterine cervical cancer. Here, we present the results of a prospective international multi-centre study evaluating the prognostic value of pre-treatment tumour oxygen partial pressure (pO(2)) and the hypoxia marker...

Evaluation of web-based annotation of ophthalmic images for multicentric clinical trials.

Science.gov (United States)

Chalam, K V; Jain, P; Shah, V A; Shah, Gaurav Y

2006-06-01

An Internet browser-based annotation system can be used to identify and describe features in digitalized retinal images, in multicentric clinical trials, in real time. In this web-based annotation system, the user employs a mouse to draw and create annotations on a transparent layer, that encapsulates the observations and interpretations of a specific image. Multiple annotation layers may be overlaid on a single image. These layers may correspond to annotations by different users on the same image or annotations of a temporal sequence of images of a disease process, over a period of time. In addition, geometrical properties of annotated figures may be computed and measured. The annotations are stored in a central repository database on a server, which can be retrieved by multiple users in real time. This system facilitates objective evaluation of digital images and comparison of double-blind readings of digital photographs, with an identifiable audit trail. Annotation of ophthalmic images allowed clinically feasible and useful interpretation to track properties of an area of fundus pathology. This provided an objective method to monitor properties of pathologies over time, an essential component of multicentric clinical trials. The annotation system also allowed users to view stereoscopic images that are stereo pairs. This web-based annotation system is useful and valuable in monitoring patient care, in multicentric clinical trials, telemedicine, teaching and routine clinical settings.

Forest biomass observation: current state and prospective

Directory of Open Access Journals (Sweden)

D. G. Schepaschenko

2017-08-01

Full Text Available With this article, we provide an overview of the methods, instruments and initiatives for forest biomass observation at global scale. We focus on the freely available information, provided by both remote and in-situ observations. The advantages and limitation of various space borne methods, including optical, radar (C, L and P band and LiDAR, as well as respective instruments available on the orbit (MODIS, Proba-V, Landsat, Sentinel-1, Sentinel-2 , ALOS PALSAR, Envisat ASAR or expecting (BIOMASS, GEDI, NISAR, SAOCOM-CS are discussed. We emphasize the role of in-situ methods in the development of a biomass models, providing calibration and validation of remote sensing data. We focus on freely available forest biomass maps, databases and empirical models. We describe the functionality of Biomass.Geo-Wiki.org portal, which provides access to a collection of global and regional biomass maps in full resolution with unified legend and units overplayed with high-resolution imagery. The Forest-Observation-System.net is announced as an international cooperation to establish a global in-situ forest biomass database to support earth observation and to encourage investment in relevant field-based observations and science. Prospects of unmanned aerial vehicles in the forest inventory are briefly discussed. The work was partly supported by ESA IFBN project (contract 4000114425/15/NL/FF/gp.

Validation of SAPS3 admission score and its customization for use in Korean intensive care unit patients: a prospective multicentre study.

Science.gov (United States)

Lim, So Yeon; Koh, Shin Ok; Jeon, Kyeongman; Na, Sungwon; Lim, Chae-Man; Choi, Won-Il; Lee, Young-Joo; Kim, Seok Chan; Chon, Gyu Rak; Kim, Je Hyeong; Kim, Jae Yeol; Lim, Jaemin; Rhee, Chin Kook; Park, Sunghoon; Kim, Ho Cheol; Lee, Jin Hwa; Lee, Ji Hyun; Park, Jisook; Koh, Younsuck; Suh, Gee Young

2013-08-01

To externally validate the simplified acute physiology score 3 (SAPS3) and to customize it for use in Korean intensive care unit (ICU) patients. This is a prospective multicentre cohort study involving 22 ICUs from 15 centres throughout Korea. The study population comprised patients who were consecutively admitted to participating ICUs from 1 July 2010 to 31 January 2011. A total of 4617 patients were enrolled. ICU mortality was 14.3%, and hospital mortality was 20.6%. The patients were randomly assigned into one of two cohorts: a development (n = 2309) or validation (n = 2308) cohort. In the development cohort, the general SAPS3 had good discrimination (area under the receiver operating characteristics curve = 0.829), but poor calibration (Hosmer-Lemeshow goodness-of-fit test H = 123.06, P Customization was achieved by altering the logit of the original SAPS3 equation. The new equation for Korean ICU patients was validated in the validation cohort, and demonstrated both good discrimination (area under the receiver operating characteristics curve = 0.835) and good calibration (H = 4.61, P = 0.799, C = 5.67, P = 0.684). General and regional Australasia SAPS3 admission scores showed poor calibration for use in Korean ICU patients, but the prognostic power of the SAPS3 was significantly improved by customization. Prediction models should be customized before being used to predict mortality in different regions of the world. © 2013 The Authors. Respirology © 2013 Asian Pacific Society of Respirology.

The impact of childhood acute rotavirus gastroenteritis on the parents’ quality of life: prospective observational study in European primary care medical practices

Directory of Open Access Journals (Sweden)

Domingo Javier

2012-05-01

Full Text Available Abstract Background Rotavirus (RV is the commonest cause of acute gastroenteritis in infants and young children worldwide. A Quality of Life study was conducted in primary care in three European countries as part of a larger epidemiological study (SPRIK to investigate the impact of paediatric rotavirus gastroenteritis (RVGE on affected children and their parents. Methods A self-administered questionnaire was linguistically validated in Spanish, Italian and Polish. The questionnaire was included in an observational multicentre prospective study of 302 children aged Results Questionnaire responses showed that acute RVGE in a child adversely affects the parents’ daily life as well as the child. Parents of children with RVGE experience worry, distress and impact on their daily activities. RVGE of greater clinical severity (assessed by the Vesikari scale was associated with higher parental worries due to symptoms and greater changes in the child’s behaviour, and a trend to higher impact on parents’ daily activities and higher parental distress, together with a higher score on the symptom severity scale of the questionnaire. Conclusions Parents of a child with acute RVGE presenting to primary care experience worry, distress and disruptions to daily life as a result of the child’s illness. Prevention of this disease through prophylactic vaccination will improve the daily lives of parents and children.

Cancer incidence and survival in Lynch syndrome patients receiving colonoscopic and gynaecological surveillance : first report from the prospective Lynch syndrome database

NARCIS (Netherlands)

Moller, Pal; Seppala, Toni; Bernstein, Inge; Holinski-Feder, Elke; Sala, Paola; Evans, D. Gareth; Lindblom, Annika; Macrae, Finlay; Blanco, Ignacio; Sijmons, Rolf; Jeffries, Jacqueline; Vasen, Hans; Burn, John; Nakken, Sigve; Hovig, Eivind; Rodland, Einar Andreas; Tharmaratnam, Kukatharmini; Cappel, Wouter H. de Vos Tot Nederveen; Hill, James; Wijnen, Juul; Green, Kate; Lalloo, Fiona; Sunde, Lone; Mints, Miriam; Bertario, Lucio; Pineda, Marta; Navarro, Matilde; Morak, Monika; Renkonen-Sinisalo, Laura; Frayling, Ian M.; Plazzer, John-Paul; Pylvanainen, Kirsi; Sampson, Julian R.; Capella, Gabriel; Mecklin, Jukka-Pekka; Moslein, Gabriela

Objective Estimates of cancer risk and the effects of surveillance in Lynch syndrome have been subject to bias, partly through reliance on retrospective studies. We sought to establish more robust estimates in patients undergoing prospective cancer surveillance. Design We undertook a multicentre

The prognosis of incurable cachectic cancer patients on home parenteral nutrition: a multi-centre observational study with prospective follow-up of 414 patients

NARCIS (Netherlands)

Bozzetti, F.; Santarpia, L.; Pironi, L.; Thul, P.; Klek, S.; Gavazzi, C.; Tinivella, M.; Joly, F.; Jonkers, C.; Baxter, J.; Gramlich, L.; Chicharro, L.; Staun, M.; van Gossum, A.; Lo Vullo, S.; Mariani, L.

2014-01-01

The role of home parenteral nutrition (HPN) in incurable cachectic cancer patients unable to eat is extremely controversial. The aim of this study is to analyse which factors can influence the outcome. We studied prospectively 414 incurable cachectic (sub)obstructed cancer patients receiving HPN and

Prospective Register Of patients undergoing repeated OFfice and Ambulatory Blood Pressure Monitoring (PROOF-ABPM): protocol for an observational cohort study.

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Sheppard, James P; Martin, Una; Gill, Paramjit; Stevens, Richard; McManus, Richard J

2016-10-31

The diagnosis and management of hypertension depends on accurate measurement of blood pressure (BP) in order to target antihypertensive treatment appropriately. Most BP measurements take place in a clinic setting, but it has long been recognised that readings taken out-of-office (via home or ambulatory monitoring) estimate true underlying BP more accurately. Recent studies have shown that the change in clinic BP over multiple readings is a significant predictor of the difference between clinic and out-of-office BP. Used in combination with patient characteristics, this change has been shown to accurately predict a patient's out-of-office BP level. The present study proposes to collect real-life BP data to prospectively validate this new prediction tool in routine clinical practice. A prospective, multicentre observational cohort design will be used, recruiting patients from primary and secondary care. All patients attending participating centres for ambulatory BP monitoring will be eligible to participate. Anonymised clinical data will be collected from all eligible patients, who will be invited to give informed consent to permit identifiable data to be collected for data linkage to external outcome registries. Descriptive statistics will be used to calculate the sensitivity, specificity, positive and negative predictive values of the out-of-office BP prediction tool. Area under the receiver operator characteristic curve statistics will be used to examine model performance. Ethical approval for this study has been obtained from the National Research. Ethics Service Committee South Central-Oxford A (reference; 15/SC/0184), and site-specific R&D approval has been acquired from the relevant NHS trusts. All findings will be presented at relevant conferences and published in peer-reviewed journals, on the study website and disseminated in lay and social media where appropriate. Published by the BMJ Publishing Group Limited. For permission to use (where not already

The Biosulin equivalence in standard therapy (BEST) study − a ...

African Journals Online (AJOL)

-label, non-randomised, interventional, observational study in subjects using Biosulin ... Methods. Subjects in this interventional, observational, multicentre, open-label, prospective study were switched from their existing human premix insulin ...

Multicentric Giant Cell Tumor of Bone: Synchronous and Metachronous Presentation

Directory of Open Access Journals (Sweden)

Reiner Wirbel

2013-01-01

Full Text Available A 27-year-old man treated 2.5 years ago for synchronous multicentric giant cell tumor of bone located at the right proximal humerus and the right 5th finger presented now with complaints of pain in his right hip and wrist of two-month duration. Radiology and magnetic resonance revealed multicentric giant cell tumor lesions of the right proximal femur, the left ileum, the right distal radius, and the left distal tibia. The patient has an eighteen-year history of a healed osteosarcoma of the right tibia that was treated with chemotherapy, resection, and allograft reconstruction. A literature review establishes this as the first reported case of a patient with synchronous and metachronous multicentric giant cell tumor who also has a history of osteosarcoma.

Cognition and bimanual performance in children with unilateral cerebral palsy: protocol for a multicentre, cross-sectional study.

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Hoare, Brian; Ditchfield, Michael; Thorley, Megan; Wallen, Margaret; Bracken, Jenny; Harvey, Adrienne; Elliott, Catherine; Novak, Iona; Crichton, Ali

2018-05-08

Motor outcomes of children with unilateral cerebral palsy are clearly documented and well understood, yet few studies describe the cognitive functioning in this population, and the associations between the two is poorly understood. Using two hands together in daily life involves complex motor and cognitive processes. Impairment in either domain may contribute to difficulties with bimanual performance. Research is yet to derive whether, and how, cognition affects a child's ability to use their two hands to perform bimanual tasks. This study will use a prospective, cross-sectional multi-centre observational design. Children (aged 6-12 years) with unilateral cerebral palsy will be recruited from one of five Australian treatment centres. We will examine associations between cognition, bimanual performance and brain neuropathology (lesion type and severity) in a sample of 131 children. The primary outcomes are: Motor - the Assisting Hand Assessment; Cognitive - Executive Function; and Brain - lesion location on structural MRI. Secondary data collected will include: Motor - Box and Blocks, ABILHAND- Kids, Sword Test; Cognitive - standard neuropsychological measures of intelligence. We will use generalized linear modelling and structural equation modelling techniques to investigate relationships between bimanual performance, executive function and brain lesion location. This large multi-centre study will examine how cognition affects bimanual performance in children with unilateral cerebral palsy. First, it is anticipated that distinct relationships between bimanual performance and cognition (executive function) will be identified. Second, it is anticipated that interrelationships between bimanual performance and cognition will be associated with common underlying neuropathology. Findings have the potential to improve the specificity of existing upper limb interventions by providing more targeted treatments and influence the development of novel methods to improve both

Food and Drug Administration criteria for the diagnosis of drug-induced valvular heart disease in patients previously exposed to benfluorex: a prospective multicentre study.

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Maréchaux, Sylvestre; Rusinaru, Dan; Jobic, Yannick; Ederhy, Stéphane; Donal, Erwan; Réant, Patricia; Arnalsteen, Elise; Boulanger, Jacques; Garban, Thierry; Ennezat, Pierre-Vladimir; Jeu, Antoine; Szymanski, Catherine; Tribouilloy, Christophe

2015-02-01

The Food and Drug Administration (FDA) criteria for diagnosis of drug-induced valvular heart disease (DIVHD) are only based on the observation of aortic regurgitation ≥ mild and/or mitral regurgitation ≥ moderate. We sought to evaluate the diagnostic value of FDA criteria in a cohort of control patients and in a cohort of patients exposed to a drug (benfluorex) known to induce VHD. This prospective, multicentre study included 376 diabetic control patients not exposed to valvulopathic drugs and 1000 subjects previously exposed to benfluorex. Diagnosis of mitral or aortic DIVHD was based on a combined functional and morphological echocardiographic analysis of cardiac valves. Patients were classified according to the FDA criteria [mitral or aortic-FDA(+) and mitral or aortic-FDA(-)]. Among the 376 control patients, 2 were wrongly classified as mitral-FDA(+) and 17 as aortic-FDA(+) (0.53 and 4.5% of false positives, respectively). Of those exposed to benfluorex, 48 of 58 with a diagnosis of mitral DIVHD (83%) were classified as mitral-FDA(-), and 901 of the 910 patients (99%) without a diagnosis of the mitral DIVHD group were classified as mitral-FDA(-). All 40 patients with a diagnosis of aortic DIVHD were classified as aortic-FDA(+), and 105 of the 910 patients without a diagnosis of aortic DIVHD (12%) were classified aortic-FDA(+). Older age and lower BMI were independent predictors of disagreement between FDA criteria and the diagnosis of DIVHD in patients exposed to benfluorex (both P ≤ 0.001). FDA criteria solely based on the Doppler detection of cardiac valve regurgitation underestimate for the mitral valve and overestimate for the aortic valve the frequency of DIVHD. Therefore, the diagnosis of DIVHD must be based on a combined echocardiographic and Doppler morphological and functional analysis of cardiac valves. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

Nocturnal emergency department visits, duration of symptoms and risk of hospitalisation among adults with asthma exacerbations: a multicentre observational study.

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Yasuda, Hideto; Hagiwara, Yusuke; Watase, Hiroko; Hasegawa, Kohei

2016-08-12

We sought to compare the characteristics of patients with asthma presenting to the emergency department (ED) during the night-time with those of patients presenting at other times of the day, and to determine whether the time of ED presentation is associated with the risk of hospitalisation. A multicentre chart review study of 23 EDs across Japan. Patients aged 18-54 years with a history of physician-diagnosed asthma, presented to the ED between January 2009 and December 2011 OUTCOME MEASURES: The outcome of interest was hospitalisation, including admissions to an observation unit, inpatient unit and intensive care unit. Among the 1354 patients (30.1% in the night-time group vs 69.9% in the other time group) included in this study, the median age was 34 years and ∼40% were male. Overall 145 patients (10.7%) were hospitalised. Patients in the night-time group were more likely to have a shorter duration of symptoms (≤3 hours) before ED presentation than those in the other time group (25.9% in night-time vs 13.4% in other times; pdifferences in respiratory rate, initial peak expiratory flow or ED asthma treatment between the two groups (p>0.05). Similarly, the risk of hospitalisation did not differ between the two groups (11.3% in night-time vs 10.5% in other times; p=0.65). In a multivariable model adjusting for potential confounders, the risk of hospitalisation in the night-time group was not statistically different from the other time group (OR, 1.10; 95% CI 0.74 to 1.61; p=0.63). This multicentre study in Japan demonstrated no significant difference in the risk of hospitalisations according to the time of ED presentation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Maternal and neonatal consequences of treated and untreated asymptomatic bacteriuria in pregnancy: a prospective cohort study with an embedded randomised controlled trial

NARCIS (Netherlands)

Kazemier, Brenda M.; Koningstein, Fiona N.; Schneeberger, Caroline; Ott, Alewijn; Bossuyt, Patrick M.; de Miranda, Esteriek; Vogelvang, Tatjana E.; Verhoeven, Corine J. M.; Langenveld, Josje; Woiski, Mallory; Oudijk, Martijn A.; van der Ven, Jeanine E. M.; Vlegels, Manita T. W.; Kuiper, Petra N.; Feiertag, Nicolette; Pajkrt, Eva; de Groot, Christianne J. M.; Mol, Ben W. J.; Geerlings, Suzanne E.

2015-01-01

Existing approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago. In this study, we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy. In this multicentre prospective cohort

External validation of prognostic models to predict risk of gestational diabetes mellitus in one Dutch cohort: prospective multicentre cohort study.

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Lamain-de Ruiter, Marije; Kwee, Anneke; Naaktgeboren, Christiana A; de Groot, Inge; Evers, Inge M; Groenendaal, Floris; Hering, Yolanda R; Huisjes, Anjoke J M; Kirpestein, Cornel; Monincx, Wilma M; Siljee, Jacqueline E; Van 't Zelfde, Annewil; van Oirschot, Charlotte M; Vankan-Buitelaar, Simone A; Vonk, Mariska A A W; Wiegers, Therese A; Zwart, Joost J; Franx, Arie; Moons, Karel G M; Koster, Maria P H

2016-08-30

 To perform an external validation and direct comparison of published prognostic models for early prediction of the risk of gestational diabetes mellitus, including predictors applicable in the first trimester of pregnancy.  External validation of all published prognostic models in large scale, prospective, multicentre cohort study.  31 independent midwifery practices and six hospitals in the Netherlands.  Women recruited in their first trimester (diabetes mellitus of any type were excluded.  Discrimination of the prognostic models was assessed by the C statistic, and calibration assessed by calibration plots.  3723 women were included for analysis, of whom 181 (4.9%) developed gestational diabetes mellitus in pregnancy. 12 prognostic models for the disorder could be validated in the cohort. C statistics ranged from 0.67 to 0.78. Calibration plots showed that eight of the 12 models were well calibrated. The four models with the highest C statistics included almost all of the following predictors: maternal age, maternal body mass index, history of gestational diabetes mellitus, ethnicity, and family history of diabetes. Prognostic models had a similar performance in a subgroup of nulliparous women only. Decision curve analysis showed that the use of these four models always had a positive net benefit.  In this external validation study, most of the published prognostic models for gestational diabetes mellitus show acceptable discrimination and calibration. The four models with the highest discriminative abilities in this study cohort, which also perform well in a subgroup of nulliparous women, are easy models to apply in clinical practice and therefore deserve further evaluation regarding their clinical impact. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Use of XenX™, the latest ureteric occlusion device with guide wire utility: results from a prospective multicentric comparative study.

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Sanguedolce, Francesco; Montanari, Emanuele; Alvarez-Maestro, Mario; Macchione, Nicola; Hruby, Stephan; Papatsoris, Athanasios; Kallidonis, Panagiotis; Villa, Luca; Honeck, Patrick; Traxer, Olivier; Greco, Francesco

2016-11-01

This is a prospective multicentric comparative study evaluating the performance of XenX-a new dual-purpose device for the prevention of stone fragments migration during ureteroscopic lithotripsy (URS). Between March 2014 and January 2015, 41 patients undertaking URS + XenX were matched with 41 patients undergoing standard URS. Patients included had unilateral ureteric stone(s) of 0.5-1.5 cm in maximum size. Demographics, complication rates and surgical outcomes were recorded for comparison. A Likert-like 5-grade scoring system was used for surgeons' evaluation of XenX properties. Cost analysis was performed by comparing weighted mean costs of the relevant procedures. Patients' characteristics between the two groups were comparable. Lasering time was longer for XenX group (13.59 vs. 5.17 min; p = 0.0001) whilst use of basket and need of JJ stent insertion was more frequent in control group (19.5 vs. 97.6 %; p = 0.0001 and 22 vs. 35 %; p = 0.001, respectively). Intra-operative SFR was significantly higher for XenX group (100 vs. 85.4 %; p = 0.0001), but not at 4-week follow-up, after ancillary procedures were needed in 17.1 % of the control group. Surgeons' evaluations for XenX were suboptimal for "Ease of Basketing" (2/5) and "Advancement of double J stent" (3/5). The use of XenX increased costs of procedures, but spared the costs associated to ancillary procedures and stent removals. XenX confirmed to be a safe and effective device especially for the treatment of upper ureteric tract stones; moreover, XenX may reduce the risk for the need of auxiliary procedures and for the insertion of a JJ stent.

Metabolic syndrome is associated with advanced prostate cancer in patients treated with radical retropubic prostatectomy: results from a multicentre prospective study

International Nuclear Information System (INIS)

De Nunzio, Cosimo; Simone, Giuseppe; Brassetti, Aldo; Mastroianni, Riccardo; Collura, Devis; Muto, Giovanni; Gallucci, Michele; Tubaro, Andrea

2016-01-01

Prostate cancer (PCa) is the most common non-skin cancer in USA and the second leading cause of cancer death in Western Countries. Despite the high mortality associated with PCa, the only established risk factors are age, race and family history. A possible association between metabolic syndrome (MetS) and PCa was firstly described in 2004 and several subsequent studies in biopsy cohorts have shown conflicting results. Aim of our multicentre prospective study was to investigate the association between MetS and PCa in men undergoing radical prostatectomy (RP). From January 2012 to June 2015, 349 consecutive men undergoing RP for PCa at three centres in Italy were enrolled into a prospective database. Body Mass Index (BMI) as well as waist circumference was measured before RP. Blood samples were also collected and tested for total PSA, fasting glucose, triglycerides and HDLs. Blood pressure was also recorded. We evaluated the association between MetS, defined according to Adult Treatment Panel III, PCa stage (advanced stage defined as pT ≥ 3 or N1) and grade (high grade defined as Gleason Score ≥ 4 + 3) using logistic regression analyses. Median age and preoperative PSA levels were 66 years (IQR: 61-69) and 7 ng/ml (IQR: 5-10), respectively. Median BMI was 26.12 kg/m 2 (IQR 24-29) with 56 (16 %) obese (BMI ≥ 30 kg/m 2 ) patients and 87 (25 %) patients with MetS. At pathological evaluation, advanced PCa and high-grade disease were present in 126 (36 %) and 145 (41.5 %) patients, respectively. MetS was significantly associated with advanced PCa (45/87, 51 % vs 81/262, 31 %; p = 0.008) and high-grade disease (47/87, 54 % vs 98/262, 37 %; p = 0.001). On multivariable analysis, MetS was an independent predictor of pathological stage ≥ pT3a or N1 (OR: 2.227; CI: 1.273-3.893; p = 0.005) and Gleason score ≥ 4 + 3 (OR: 2.007, CI: 1.175-3.428; p = 0.011). We firstly demonstrated in a European radical retropubic prostatectomy cohort study that MetS is associated with

Aprotinin vs. tranexamic acid in isolated coronary artery bypass surgery: A multicentre observational study.

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Deloge, Elsa; Amour, Julien; Provenchère, Sophie; Rozec, Bertrand; Scherrer, Bruno; Ouattara, Alexandre

2017-05-01

Aprotinin appears to be more efficacious than lysine analogues to reduce bleeding and transfusion of blood products in high-transfusion-risk cardiac surgical patients. However, in isolated coronary artery bypass graft (CABG) surgery, the results from head-to-head trials remain less conclusive. Our objective was to compare the efficacies and safety of aprotinin and tranexamic acid (TXA) in patients undergoing isolated on-pump CABG. A multicentre before-and-after study pooling individual data from published trials and unpublished data from three other databases. Four tertiary care teaching hospitals (Haut-Lévêque Hospital in Bordeaux, Pitié-Salpêtrière Hospital and Bichat-Claude Bernard Hospital in Paris, and Laennec Hospital in Nantes). We included data of 2496 isolated on-pump CABG surgery patients who received either aprotinin between November 2003 and May 2008 (n = 1267) or TXA between November 2007 and November 2013 (n = 1229). The primary outcome was total blood loss within 24 h after operation. Secondary outcomes were transfusion of blood products, reoperation for bleeding, renal replacement therapy, ICU length of stay and in-hospital mortality. Adjusted mean (SEM) 24-h blood loss after surgery [483 (11) vs. 634 (11) ml, P < 0.0001] and the proportion of patients requiring intraoperative blood product transfusion (32.7 vs. 46.5%, P = 0.01) were lower in aprotinin-treated patients. No difference was observed with regard to reoperations for bleeding, renal replacement therapy and in-hospital mortality. However, patients receiving aprotinin had a significantly shorter adjusted ICU length of stay. In patients undergoing isolated CABG, aprotinin was more effective than TXA in reducing postoperative blood loss, and no safety concerns were identified. The benefits of aprotinin should be considered when evaluating the risk of major blood loss and transfusion in patients scheduled for isolated CABG surgery.

Elective frozen elephant trunk procedure using the E-Vita Open Plus prosthesis in 94 patients: a multicentre French registry.

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Verhoye, Jean-Philippe; Belhaj Soulami, Reda; Fouquet, Olivier; Ruggieri, Vito Giovanni; Kaladji, Adrien; Tomasi, Jacques; Sellin, Michel; Farhat, Fadi; Anselmi, Amedeo

2017-10-01

Our goal was to evaluate the operative outcomes of the frozen elephant trunk technique using the E-Vita Open Plus® hybrid prosthesis in chronic aortic arch diseases and report clinical and radiological outcomes at the 1-year follow-up. As determined from a prospective multicentre registry, 94 patients underwent frozen elephant trunk procedures using the E-Vita Open Plus hybrid device for the treatment of chronic aortic conditions, including 50% chronic aortic dissections, 40% degenerative aneurysms and 10% miscellaneous indications. Fifty percent of the cases were reoperations. The perioperative mortality rate was 11.7%. Spinal cord ischaemia and stroke rates were 4% and 9.6%, respectively. The mean cardiopulmonary bypass time was 252 ± 97 min, cardiac ischaemia time was 152 ± 53 min and cerebral perfusion time was 82 ± 22 min. Concomitant procedures were observed in 15% of patients. Among the 83 surviving patients, the survival rate after the 1-year follow-up was 98%. Eleven percent of patients underwent endovascular completion, whereas 4% of patients required aortic reintervention at 1 year. The E-Vita Open Plus hybrid device confirms the favourable short- and mid-term outcomes offered by its predecessor in frozen elephant trunk procedures in patients with chronic aortic arch disease. Implantation of the E-Vita Open Plus is associated with good 1-year survival rates, good rates of favourable aortic remodelling in both chronic dissection and degenerative aneurysms and a reproducible technique in a multicentre registry. Continued follow-up is required due to the risk of evolution at the downstream aorta. © The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial.

Science.gov (United States)

Ardehali, Abbas; Esmailian, Fardad; Deng, Mario; Soltesz, Edward; Hsich, Eileen; Naka, Yoshifumi; Mancini, Donna; Camacho, Margarita; Zucker, Mark; Leprince, Pascal; Padera, Robert; Kobashigawa, Jon

2015-06-27

The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation. We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT00855712. Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events. Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study. TransMedics. Copyright © 2015 Elsevier Ltd. All rights reserved.

L-Carnitine-supplementation in advanced pancreatic cancer (CARPAN - a randomized multicentre trial

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Kraft Matthias

2012-07-01

Full Text Available Abstract Background Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia. Findings We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM kg. During treatment body-mass-index increased by 3,4 ± 1,4% under L-Carnitine and decreased (−1,5 ± 1,4% in controls (p  Conclusion While these data are preliminary and need confirmation they indicate that patients with pancreatic cancer may have a clinically relevant benefit from the inexpensive and well tolerated oral supplementation of L-Carnitine.

[A retrospective, observational and multicentre study on patients with hyperactive bladder on treatment with mirabegron and oxybutinine under usual clinical practice conditions].

Science.gov (United States)

Sicras-Mainar, A; Navarro-Artieda, R; Ruiz-Torrejón, A; Saez, M; Coll-de Tuero, G; Sánchez, L

To evaluate therapeutic persistence, healthcare resources, medical costs and adverse events of oxybutynin and mirabegron treatments in patients with overactive bladder in routine medical practice. An observational, retrospective, multicentre study was carried out using the records of patients attended to in 3 different geographic locations (Barcelona, Girona, Asturias). An analysis was made on the 2 study groups (oxybutynin and mirabegron). Follow-up time was one year. Persistence was defined as the time (months), without discontinuation of the initial treatment, or without change of treatment at least 60 days after the initial prescription. Primary endpoints: comorbidity, healthcare resources used, and adverse events. The data was analysed using the SPSSWIN Program, with a significance of Pbladder had similar persistence with the treatment, lower healthcare costs, but with higher oxybutynin vs. mirabegron adverse reaction rates. Copyright © 2016 Sociedad Española de Médicos de Atención Primaria (SEMERGEN). Publicado por Elsevier España, S.L.U. All rights reserved.

Prospective Observations of Discomfort, Pain, and Dyspnea in Nursing Home Residents With Dementia and Pneumonia

NARCIS (Netherlands)

Maaden, T. van der; Steen, J.T. van der; Vet, H.C. de; Hertogh, C.M.; Koopmans, R.T.

2016-01-01

OBJECTIVES: To describe observations of suffering in patients with dementia from the diagnosis of pneumonia until cure or death. DESIGN: Prospective observational study between January 2012 and May 2014. SETTING: Dutch nursing homes (32). PARTICIPANTS: Nursing home patients with dementia and

Multicentre structural and functional MRI

OpenAIRE

Gountouna, Viktoria-Eleni

2014-01-01

Neuroimaging techniques are likely to continue to improve our understanding of the brain in health and disease, but studies tend to be small, based in one imaging centre and of uncertain generalisability. Multicentre imaging studies therefore have great appeal but it is not yet clear under which circumstances data from different scanners can be combined. The successful harmonisation of multiple Magnetic Resonance Imaging (MRI) machines will increase study power, flexibility and...

Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: international multicentre prospective study.

Science.gov (United States)

Stanley, Adrian J; Laine, Loren; Dalton, Harry R; Ngu, Jing H; Schultz, Michael; Abazi, Roseta; Zakko, Liam; Thornton, Susan; Wilkinson, Kelly; Khor, Cristopher J L; Murray, Iain A; Laursen, Stig B

2017-01-04

 To compare the predictive accuracy and clinical utility of five risk scoring systems in the assessment of patients with upper gastrointestinal bleeding.  International multicentre prospective study.  Six large hospitals in Europe, North America, Asia, and Oceania.  3012 consecutive patients presenting over 12 months with upper gastrointestinal bleeding.  Comparison of pre-endoscopy scores (admission Rockall, AIMS65, and Glasgow Blatchford) and post-endoscopy scores (full Rockall and PNED) for their ability to predict predefined clinical endpoints: a composite endpoint (transfusion, endoscopic treatment, interventional radiology, surgery, or 30 day mortality), endoscopic treatment, 30 day mortality, rebleeding, and length of hospital stay. Optimum score thresholds to identify low risk and high risk patients were determined.  The Glasgow Blatchford score was best (area under the receiver operating characteristic curve (AUROC) 0.86) at predicting intervention or death compared with the full Rockall score (0.70), PNED score (0.69), admission Rockall score (0.66, and AIMS65 score (0.68) (all P<0.001). A Glasgow Blatchford score of ≤1 was the optimum threshold to predict survival without intervention (sensitivity 98.6%, specificity 34.6%). The Glasgow Blatchford score was better at predicting endoscopic treatment (AUROC 0.75) than the AIMS65 (0.62) and admission Rockall scores (0.61) (both P<0.001). A Glasgow Blatchford score of ≥7 was the optimum threshold to predict endoscopic treatment (sensitivity 80%, specificity 57%). The PNED (AUROC 0.77) and AIMS65 scores (0.77) were best at predicting mortality, with both superior to admission Rockall score (0.72) and Glasgow Blatchford score (0.64; P<0.001). Score thresholds of ≥4 for PNED, ≥2 for AIMS65, ≥4 for admission Rockall, and ≥5 for full Rockall were optimal at predicting death, with sensitivities of 65.8-78.6% and specificities of 65.0-65.3%. No score was helpful at predicting rebleeding or length

Authorship issues in multi-centre clinical trials

DEFF Research Database (Denmark)

Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

2015-01-01

Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for th...

Quality control and data-handling in multicentre studies: the case of the Multicentre Project for Tuberculosis Research

Directory of Open Access Journals (Sweden)

Caloto Teresa

2001-12-01

Full Text Available Abstract Background The Multicentre Project for Tuberculosis Research (MPTR was a clinical-epidemiological study on tuberculosis carried out in Spain from 1996 to 1998. In total, 96 centres scattered all over the country participated in the project, 19935 "possible cases" of tuberculosis were examined and 10053 finally included. Data-handling and quality control procedures implemented in the MPTR are described. Methods The study was divided in three phases: 1 preliminary phase, 2 field work 3 final phase. Quality control procedures during the three phases are described. Results: Preliminary phase: a organisation of the research team; b design of epidemiological tools; training of researchers. Field work: a data collection; b data computerisation; c data transmission; d data cleaning; e quality control audits; f confidentiality. Final phase: a final data cleaning; b final analysis. Conclusion The undertaking of a multicentre project implies the need to work with a heterogeneous research team and yet at the same time attain a common goal by following a homogeneous methodology. This demands an additional effort on quality control.

Erysipelas of the leg (cellulitis in sub-Saharan Africa: A multicentric study of 562 cases

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Bayaki Saka

2017-01-01

Full Text Available Introduction: Erysipelas of the leg is a common and serious infection. We carried out this study aiming at describing the epidemiological and clinical characteristics, and assessing the risks factors associated with the local complications of erysipelas of the leg in sub-Saharan Africa. Methods: This was a prospective multicentric study carried out in the dermatology units of Hospitals located in seven sub-Saharan African countries during a period of 12 months. Patients aged 15 and above with a first episode of erysipelas of the leg were recruited. Results: In this study, 562 patients were recruited, having a mean age of 43.7±16.9 years and a sex-ratio (M/F of 0.67. Patients infected on one leg were 562 while those infected with two were 27. Bullous forms of the disease were observed in 95 patients, while purpuric forms were observed in 167 patients. The existence of a point of entry (485 cases, obesity (230, lymph edema (130 and the use of bleaching agents (97 were the mains risk factors. Complications during the course of the infection such as necrotizing fasciitis (34 cases and abscesses (63 cases were observed. They were due to the use of antibiotics and non-steroidal anti-inflammatory treatments, and the use of cataplasm. Conclusion: This study reveals that existence of a point of entry, obesity and lymph edema, and the use of bleaching agents were the mains risk factors influencing the local complications of erysipelas of the leg. Necrotizing fasciitis and abscesses were influenced by the use of antibiotics and non-steroidal anti-inflammatory treatments, and the use of cataplasm.

Coexistence of IgM antihepatitis A virus and IgM antihepatitis E virus in acute viral hepatitis: a prospective, multicentre study in Korea.

Science.gov (United States)

Jang, J-H; Jung, Y M; Kim, J S; Lee, S H; Kim, J-W; Hwang, S G; Rim, K S; Park, S J; Park, Y M; Kang, S-K; Lee, H S; Yun, H; Kim, J-H; Jeong, S-H

2011-10-01

This study investigated the clinical, serological and molecular characteristics of coexistence of both immunoglobulin M (IgM) antihepatitis A virus (HAV) and IgM antihepatitis E virus (HEV) in acute viral hepatitis using a prospective, multicentre design. Among a total of 771 symptomatic cases with acute viral hepatitis enrolled in a Korean city from September 2006 to August 2008, coexistence of IgM anti-HAV and IgM anti-HEV was found in 43 patients (A+E group; 6%), while the existence of IgM anti-HAV alone was found in 595 patients (A group; 77%) and that of IgM anti-HEV alone in 14 patients (E group; 2%). Clinical data analysis and measurement of IgM and IgG anti-HEV were performed using two different commercial kits, and HAV RNA and HEV RNA were detected in available serum or stool samples. The clinical features of the A+E group were similar to those of the A group. HAV RNA detection rates in the A+E and A group were similar, while HEV RNA was detected only in the stool samples of the E group, not in the A+E group. Comparative testing of anti-HEV using two different ELISA kits showed markedly discordant results for IgM anti-HEV positivity and consistently low positivity for IgG anti-HEV in the A+E group. Coexistence of IgM anti-HEV measured by the Genelabs ELISA kit in the setting of hepatitis A appears to yield false-positive results in nonendemic areas of HEV infection. Diagnosis of hepatitis E using IgM anti-HEV should be made with caution. © 2011 Blackwell Publishing Ltd.

The South African Surgical Outcomes Study: a seven-day ...

African Journals Online (AJOL)

LR Mathivha, TR Mokoena, S Monokoane, Rui Moreno, David ... Method: A seven-day national, multicentre, prospective, observational cohort study was conducted in 50 government-funded hospitals in South .... Dr George Mukhari Hospital.

Authorship issues in multi-centre clinical trials

DEFF Research Database (Denmark)

Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian

2015-01-01

to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference...... to the original source....

Does the age of acute care physicians impact their (1) crisis management performance and (2) learning after simulation-based education? A protocol for a multicentre prospective cohort study in Toronto and Ottawa, Canada.

Science.gov (United States)

Alam, Fahad; LeBlanc, Vicki R; Baxter, Alan; Tarshis, Jordan; Piquette, Dominique; Gu, Yuqi; Filipkowska, Caroline; Krywenky, Ashley; Kester-Greene, Nicole; Cardinal, Pierre; Au, Shelly; Lam, Sandy; Boet, Sylvain; Clinical Trials Group, Perioperative Anesthesia

2018-04-21

The proportion of older acute care physicians (ACPs) has been steadily increasing. Ageing is associated with physiological changes and prospective research investigating how such age-related physiological changes affect clinical performance, including crisis resource management (CRM) skills, is lacking. There is a gap in the literature on whether physician's age influences baseline CRM performance and also learning from simulation. We aim to investigate whether ageing is associated with baseline CRM skills of ACPs (emergency, critical care and anaesthesia) using simulated crisis scenarios and to assess whether ageing influences learning from simulation-based education. This is a prospective cohort multicentre study recruiting ACPs from the Universities of Toronto and Ottawa, Canada. Each participant will manage an advanced cardiovascular life support crisis-simulated scenario (pretest) and then be debriefed on their CRM skills. They will then manage another simulated crisis scenario (immediate post-test). Three months after, participants will return to manage a third simulated crisis scenario (retention post-test). The relationship between biological age and chronological age will be assessed by measuring the participants CRM skills and their ability to learn from high-fidelity simulation. This protocol was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB Number 140-2015) and the Ottawa Health Science Network Research Ethics Board (#20150173-01H). The results will be disseminated in a peer-reviewed journal and at scientific meetings. NCT02683447; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Multicentric Castleman's disease & HIV infection.

LENUS (Irish Health Repository)

Cotter, A

2009-10-01

We report the case of a 35 year patient from Nigeria who presented with fever and splenomegaly. The initial diagnosis was Salmonellosis. However, relapsing symptoms lead to a re-evaluation and ultimately a diagnosis of Multicentric Castleman\\'s Disease (MCD). There is no gold standard treatment but our patient responded to Rituximab and Highly active anti-retroviral therapy. MCD is a rare, aggressive disease that should be considered in a HIV positive patient presenting with fever and significant lymphadenopathy.

Management of SPN in France. Pathways for definitive diagnosis of solitary pulmonary nodule: a multicentre study in 18 French districts

International Nuclear Information System (INIS)

Alzahouri, Kazem; Velten, Michel; Arveux, Patrick; Woronoff-Lemsi, Marie-Christine; Jolly, Damien; Guillemin, Francis

2008-01-01

The process of diagnosis and management of solitary pulmonary nodules (SPNs) between 1 and 3 cm is not standardized. This multicentre study investigated how diagnosis of newly discovered SPNs is managed in routine practice. We examined 11,515 radiology reports of patients undergoing chest computed tomography (CT) at all 76 radiology centres in 18 French administrative districts covering 8,220,000 people. Information on diagnostic procedures and treatment administered from discovery to definitive diagnosis of SPN was collected prospectively. We identified 152 cases of newly diagnosed SPNs. Follow-up was complete for 112 patients. The median number of diagnostic tests was 4 and the mean time to diagnosis was 41.4 days. Marked variability was observed in the sequence of diagnostic tests, and 8 diagnostic pathways were identified. Patients' characteristics and radiological features of SPNs influenced the number of tests performed. Referral by specialist, history of smoking and spiculated SPN predicted the performance of at least one invasive procedure (P < 0.01). Definitive diagnosis was a malignant disease in 30 patients (26%). The diagnosis of SPN is a complex process that physicians approach in markedly different ways. Implementing practice guidelines for managing the diagnosis of SPN requires clarification

A multicomponent approach to identify predictors of hospital outcomes in older in-patients: a multicentre, observational study.

Directory of Open Access Journals (Sweden)

Stefanie L De Buyser

Full Text Available BACKGROUND: The identification of older patients at risk of poor hospital outcomes (e.g. longer hospital stay, in-hospital mortality, and institutionalisation is important to provide an effective healthcare service. OBJECTIVE: To identify factors related to older patients' clinical, nutritional, functional and socio-demographic profiles at admission to an acute care ward that can predict poor hospital outcomes. DESIGN AND SETTING: The CRiteria to assess appropriate Medication use among Elderly complex patients project was a multicentre, observational study performed in geriatric and internal medicine acute care wards of seven Italian hospitals. SUBJECTS: One thousand one hundred twenty-three consecutively admitted patients aged 65 years or older. METHODS: Hospital outcomes were length of stay, in-hospital mortality, and institutionalisation. RESULTS: Mean age of participants was 81 years, 56% were women. Median length of stay was 10 (7-14 days, 41 patients died during hospital stay and 37 were newly institutionalised. Number of drugs before admission, metastasized cancer, renal failure or dialysis, infection, falls at home during the last year, pain, and walking speed were independent predictors of LoS. Total dependency in activities of daily living and inability to perform grip strength test were independent predictors of in-hospital mortality. Malnutrition and total dependency in activities of daily living were independent predictors of institutionalisation. CONCLUSIONS: Our results confirm that not only diseases, but also multifaceted aspects of ageing such as physical function and malnutrition are strong predictors of hospital outcomes and suggest that these variables should be systematically recorded.

Uterine artery embolisation for uterine leiomyomas | Lawson | South ...

African Journals Online (AJOL)

: Prospective observational multi-centre study. Methods: 36 women (mean age 38 years, range 30 - 47 years) with symptomatic fibroids were treated with UAE between November 2009 and. February 2012. Pre-procedure magnetic resonance ...

A prospective, comparative, observational study on optical coherence tomography of the anterior eye segment

NARCIS (Netherlands)

Theelen, T.; Hoyng, C.B.

2013-01-01

BACKGROUND: We compared two commercially available spectral-domain optical coherence tomography (OCT) devices according to their capacity of imaging the anterior segment of the eye with the same detail and quality. METHODS: A prospective, observational, single-visit study with individuals aged 18

Coerced hospital admission and symptom change--a prospective observational multi-centre study.

Directory of Open Access Journals (Sweden)

Thomas W Kallert

Full Text Available INTRODUCTION: Coerced admission to psychiatric hospitals, defined by legal status or patient's subjective experience, is common. Evidence on clinical outcomes however is limited. This study aimed to assess symptom change over a three month period following coerced admission and identify patient characteristics associated with outcomes. METHOD: At study sites in 11 European countries consecutive legally involuntary patients and patients with a legally voluntary admission who however felt coerced, were recruited and assessed by independent researchers within the first week after admission. Symptoms were assessed on the Brief Psychiatric Rating Scale. Patients were re-assessed after one and three months. RESULTS: The total sample consisted of 2326 legally coerced patients and 764 patients with a legally voluntary admission who felt coerced. Symptom levels significantly improved over time. In a multivariable analysis, higher baseline symptoms, being unemployed, living alone, repeated hospitalisation, being legally a voluntary patient but feeling coerced, and being initially less satisfied with treatment were all associated with less symptom improvement after one month and, other than initial treatment satisfaction, also after three months. The diagnostic group was not linked with outcomes. DISCUSSION: On average patients show significant but limited symptom improvements after coerced hospital admission, possibly reflecting the severity of the underlying illnesses. Social factors, but not the psychiatric diagnosis, appear important predictors of outcomes. Legally voluntary patients who feel coerced may have a poorer prognosis than legally involuntary patients and deserve attention in research and clinical practice.

The diagnostic and therapeutic impact of MRI: an observational multi-centre study

International Nuclear Information System (INIS)

Hollingworth, William; Todd, Christopher J.; Bell, Matthew I.; Arafat, Qais; Girling, Simon; Karia, Kanti R.; Dixon, Adrian K.

2000-01-01

AIM: To provide information about the diagnostic and therapeutic impact of magnetic resonance imaging (MRI) and to compare the findings across diagnostic groups. MATERIALS AND METHODS: A prospective, observational study of 2017 consecutive referrals for MRI of the head, spine or knee at four imaging centres. Clinicians completed questionnaires before MRI stating initial diagnoses, diagnostic confidence and treatment plans. After imaging, a second questionnaire evaluated clinicians' revised diagnosis and treatment plans in the light of imaging findings. Patients were grouped into nine diagnostic categories for analysis. Comparison between pre- and post-imaging was used to assess the diagnostic and therapeutic impact of MRI. RESULTS: In seven of nine diagnostic groups MRI findings were associated with a diagnostic impact. Diagnoses were revised or discarded following normal MR findings and diagnostic confidence was increased by confirmative MR findings. There was no statistically significant diagnostic impact for suspected pituitary or cerebello-pontine angle lesions. In five of nine diagnostic groups (knee meniscus, knee ligament, multiple sclerosis, lumbar and cervical spine) MRI findings had a clear impact on treatment plans. CONCLUSION: This study demonstrates that in most diagnostic categories, MRI influences diagnosis and treatment. However, experimental studies are needed to prove that these diagnostic and therapeutic impacts lead to improved health. Hollingworth (2000)

The diagnostic and therapeutic impact of MRI: an observational multi-centre study

Energy Technology Data Exchange (ETDEWEB)

Hollingworth, William; Todd, Christopher J.; Bell, Matthew I.; Arafat, Qais; Girling, Simon; Karia, Kanti R.; Dixon, Adrian K

2000-11-01

AIM: To provide information about the diagnostic and therapeutic impact of magnetic resonance imaging (MRI) and to compare the findings across diagnostic groups. MATERIALS AND METHODS: A prospective, observational study of 2017 consecutive referrals for MRI of the head, spine or knee at four imaging centres. Clinicians completed questionnaires before MRI stating initial diagnoses, diagnostic confidence and treatment plans. After imaging, a second questionnaire evaluated clinicians' revised diagnosis and treatment plans in the light of imaging findings. Patients were grouped into nine diagnostic categories for analysis. Comparison between pre- and post-imaging was used to assess the diagnostic and therapeutic impact of MRI. RESULTS: In seven of nine diagnostic groups MRI findings were associated with a diagnostic impact. Diagnoses were revised or discarded following normal MR findings and diagnostic confidence was increased by confirmative MR findings. There was no statistically significant diagnostic impact for suspected pituitary or cerebello-pontine angle lesions. In five of nine diagnostic groups (knee meniscus, knee ligament, multiple sclerosis, lumbar and cervical spine) MRI findings had a clear impact on treatment plans. CONCLUSION: This study demonstrates that in most diagnostic categories, MRI influences diagnosis and treatment. However, experimental studies are needed to prove that these diagnostic and therapeutic impacts lead to improved health. Hollingworth (2000)

Coagulation Profile Dynamics in Pediatric Patients with Cushing Syndrome: A Prospective, Observational Comparative Study

NARCIS (Netherlands)

Birdwell, L. (Leah); M.B. Lodish (Maya Beth); Tirosh, A. (Amit); P. Chittiboina (Prashant); M. Keil (Mark); Lyssikatos, C. (Charlampos); Belyavskaya, E. (Elena); R.A. Feelders (Richard); C.A. Stratakis (Constantine)

2016-01-01

textabstractObjective To evaluate the association between Cushing syndrome and hypercoagulability in children. Study design A prospective, observational study was performed of 54 patients with Cushing syndrome, 15.1 ± 3.9 years, treated at the National Institutes of Health Clinical Center.

A multi-centre evaluation of oral cancer in Southern and Western Nigeria: an African oral pathology research consortium initiative.

Science.gov (United States)

Omitola, Olufemi Gbenga; Soyele, Olujide Oladele; Sigbeku, Opeyemi; Okoh, Dickson; Akinshipo, Abdulwarith Olaitan; Butali, Azeez; Adeola, Henry Ademola

2017-01-01

Oral cancer is a leading cause of cancer deaths among African populations. Lack of standard cancer registries and under-reporting has inaccurately depicted its magnitude in Nigeria. Development of multi-centre collaborative oral pathology networks such as the African Oral Pathology Research Consortium (AOPRC) facilitates skill and expertise exchange and fosters a robust and systematic investigation of oral diseases across Africa. In this descriptive cross-sectional study, we have leveraged the auspices of the AOPRC to examine the burden of oral cancer in Nigeria, using a multi-centre approach. Data from 4 major tertiary health institutions in Western and Southern Nigeria was generated using a standardized data extraction format and analysed using the SPSS data analysis software (version 20.0; SPSS Inc. Chicago, IL). Of the 162 cases examined across the 4 centres, we observed that oral squamous cell carcinomas (OSCC) occurred mostly in the 6 th and 7 th decades of life and maxillary were more frequent than mandibular OSCC lesions. Regional variations were observed both for location, age group and gender distribution. Significant regional differences was found between poorly, moderately and well differentiated OSCC (p value = 0.0071). A multi-centre collaborative oral pathology research approach is an effective way to achieve better insight into the patterns and distribution of various oral diseases in men of African descent. The wider outlook for AOPRC is to employ similar approaches to drive intensive oral pathology research targeted at addressing the current morbidity and mortality of various oral diseases across Africa.

Cohort profile of BIOMArCS: the BIOMarker study to identify the Acute risk of a Coronary Syndrome-a prospective multicentre biomarker study conducted in the Netherlands.

Science.gov (United States)

Oemrawsingh, Rohit M; Akkerhuis, K Martijn; Umans, Victor A; Kietselaer, Bas; Schotborgh, Carl; Ronner, Eelko; Lenderink, Timo; Liem, Anho; Haitsma, David; van der Harst, Pim; Asselbergs, Folkert W; Maas, Arthur; Oude Ophuis, Anton J; Ilmer, Ben; Dijkgraaf, Rene; de Winter, Robbert-Jan; The, S Hong Kie; Wardeh, Alexander J; Hermans, Walter; Cramer, Etienne; van Schaik, Ron H; Hoefer, Imo E; Doevendans, Pieter A; Simoons, Maarten L; Boersma, Eric

2016-12-23

Progression of stable coronary artery disease (CAD) towards acute coronary syndrome (ACS) is a dynamic and heterogeneous process with many intertwined constituents, in which a plaque destabilising sequence could lead to ACS within short time frames. Current CAD risk assessment models, however, are not designed to identify increased vulnerability for the occurrence of coronary events within a precise, short time frame at the individual patient level. The BIOMarker study to identify the Acute risk of a Coronary Syndrome (BIOMArCS) was designed to evaluate whether repeated measurements of multiple biomarkers can predict such 'vulnerable periods'. BIOMArCS is a multicentre, prospective, observational study of 844 patients presenting with ACS, either with or without ST-elevation and at least one additional cardiovascular risk factor. We hypothesised that patterns of circulating biomarkers that reflect the various pathophysiological components of CAD, such as distorted lipid metabolism, vascular inflammation, endothelial dysfunction, increased thrombogenicity and ischaemia, diverge in the days to weeks before a coronary event. Divergent biomarker patterns, identified by serial biomarker measurements during 1-year follow-up might then indicate 'vulnerable periods' during which patients with CAD are at high short-term risk of developing an ACS. Venepuncture was performed every fortnight during the first half-year and monthly thereafter. As prespecified, patient enrolment was terminated after the primary end point of cardiovascular death or hospital admission for non-fatal ACS had occurred in 50 patients. A case-cohort design will explore differences in temporal patterns of circulating biomarkers prior to the repeat ACS. Follow-up and event adjudication have been completed. Prespecified biomarker analyses are currently being performed and dissemination through peer-reviewed publications and conference presentations is expected from the third quarter of 2016. Should

Treatment of unicentric and multicentric Castleman disease and the role of radiotherapy.

Science.gov (United States)

Chronowski, G M; Ha, C S; Wilder, R B; Cabanillas, F; Manning, J; Cox, J D

2001-08-01

Although surgery is considered standard therapy for unicentric Castleman disease, favorable responses to radiotherapy also have been documented. The authors undertook this study to analyze the clinical factors, treatment approaches, and outcomes of patients with unicentric or multicentric Castleman disease, and to report the outcomes of patients with unicentric Castleman disease treated with radiotherapy. The authors reviewed the medical records of 22 patients who had received a histologic diagnosis of Castleman disease at the University of Texas M. D. Anderson Cancer Center between 1988 and 1999. One patient with a concurrent histopathologic diagnosis of nonsecretory multiple myeloma was excluded from the study. In all patients, the diagnosis of Castleman disease was based on the results of lymph node biopsies. Disease was categorized as being either unicentric or multicentric and further subdivided into hyaline vascular, plasma cell, or mixed variant histologic types. Clinical variables and outcomes were analyzed according to treatment, which consisted of surgery, chemotherapy, or radiotherapy. Records from 21 patients were analyzed: 12 had unicentric disease, and 9 had multicentric disease. The mean follow-up time for the entire series was 51 months (median, 40 months). Four patients with unicentric disease were treated with radiotherapy alone: 2 remain alive and symptom free, 2 died of causes unrelated to Castleman disease and had no evidence of disease at last follow-up. Eight patients with unicentric disease were treated with complete or partial surgical resection, and all are alive and asymptomatic. All nine patients with multicentric disease were treated with combination chemotherapy: five are alive with no evidence of disease, and four are alive with progressive disease. Surgery results in excellent rates of cure in patients with unicentric Castleman disease; radiotherapy can also achieve clinical response and cure in selected patients. Multicentric

Revisiting the Robustness of PET-Based Textural Features in the Context of Multi-Centric Trials.

Science.gov (United States)

Bailly, Clément; Bodet-Milin, Caroline; Couespel, Solène; Necib, Hatem; Kraeber-Bodéré, Françoise; Ansquer, Catherine; Carlier, Thomas

2016-01-01

This study aimed to investigate the variability of textural features (TF) as a function of acquisition and reconstruction parameters within the context of multi-centric trials. The robustness of 15 selected TFs were studied as a function of the number of iterations, the post-filtering level, input data noise, the reconstruction algorithm and the matrix size. A combination of several reconstruction and acquisition settings was devised to mimic multi-centric conditions. We retrospectively studied data from 26 patients enrolled in a diagnostic study that aimed to evaluate the performance of PET/CT 68Ga-DOTANOC in gastro-entero-pancreatic neuroendocrine tumors. Forty-one tumors were extracted and served as the database. The coefficient of variation (COV) or the absolute deviation (for the noise study) was derived and compared statistically with SUVmax and SUVmean results. The majority of investigated TFs can be used in a multi-centric context when each parameter is considered individually. The impact of voxel size and noise in the input data were predominant as only 4 TFs presented a high/intermediate robustness against SUV-based metrics (Entropy, Homogeneity, RP and ZP). When combining several reconstruction settings to mimic multi-centric conditions, most of the investigated TFs were robust enough against SUVmax except Correlation, Contrast, LGRE, LGZE and LZLGE. Considering previously published results on either reproducibility or sensitivity against delineation approach and our findings, it is feasible to consider Homogeneity, Entropy, Dissimilarity, HGRE, HGZE and ZP as relevant for being used in multi-centric trials.

Objective and subjective outcomes of strabismus surgery in Graves' orbitopathy: a prospective multicentre study

NARCIS (Netherlands)

Jellema, Hinke Marijke; Saeed, Peerooz; Mombaerts, Ilse; Dolman, Peter J.; Garrity, Jim; Kazim, Mike; Dhrami-Gavazi, Elona; Lyons, Christopher; Nieuwkerk, Pythia; Mourits, Maarten P.

2017-01-01

To assess the change and interrelationship of the field of binocular single vision (BSV) and the quality of life (QoL), tested with two different tools, after one or two strabismus surgeries in patients with Graves' orbitopathy (GO). Prospectively, consecutive patients with GO who were scheduled for

Hepatitis E virus infection and acute non-traumatic neurological injury: A prospective multicentre study

NARCIS (Netherlands)

Dalton, H.R.; Eijk, J.J.J. van; Cintas, P.; Madden, R.G.; Jones, C.; Webb, G.W.; Norton, B.; Pique, J.; Lutgens, S.; Devooght-Johnson, N.; Woolson, K.; Baker, J.; Saunders, M.; Househam, L.; Griffiths, J.; Abravanel, F.; Izopet, J.; Kamar, N.; Alfen, N. van; Engelen, B.G.M. van; Hunter, J.G.; Eijk, A.A. van der; Bendall, R.P.; McLean, B.N.; Jacobs, B.C.

2017-01-01

BACKGROUND & AIMS: Hepatitis E virus (HEV) has been associated with a number of neurological syndromes, but causality has not yet been established. The aim of this study was to explore the relationship between HEV and neurological illness by prospective HEV testing of patients presenting with acute

Correlation of Apgar Score with Asphyxial Hepatic Injury and Mortality in Newborns: A Prospective Observational Study from India

Directory of Open Access Journals (Sweden)

Deepak Sharma

2016-01-01

Full Text Available Objective The objective of this study is to determine the correlation of Apgar score with asphyxial hepatic injury and neonatal mortality in moderately and severely asphyxiated newborns. Material and Methods This is a secondary analysis of our prospective observational case-controlled study. Sixteen neonates with severe birth asphyxia (five-minute Apgar ≤3 were compared with either 54 moderate asphyxia neonates (five-minute Apgar >3 or 30 normal neonates. Liver function tests were measured on postnatal days 1, 3, and 10 in the study and control groups. Neonatal mortality was observed in the study and control population. Results Correlation of Apgar score in severely asphyxiated neonates compared with normal Apgar score neonates and moderately asphyxiated neonates for deranged hepatic function showed significant correlation (odds ratio [OR] 4.88, 95% CI 3.26–5.84, P = 0.01 and OR 2.46, 95% CI 1.94–3.32, P = 0.02, respectively. There was a significant increase in serum lactate dehydrogenase (LDH and total bilirubin on day 1 and serum LDH at age of 10th postnatal life in severely asphyxiated neonates when compared to moderately asphyxiated neonates, whereas there was a significant decrease in total bilirubin and serum albumin on day 3 in severely asphyxiated neonates. There was a significant increase in serum alanine transaminase, serum LDH, and total bilirubin on day 1, serum aspartate transaminase, serum LDH, and total bilirubin on day 3, and International Normalized Ratio on day 10 of postnatal life when severely asphyxiated neonates were compared with normal neonates. There was a significant reduction in total protein and serum albumin on day 1 and direct bilirubin on day 3 in severely asphyxiated neonates when compared with normal neonates. There was a significant increase in neonatal mortality in severely asphyxiated neonates when compared to the other two groups. Correlation of Apgar score in severely asphyxiated neonates compared with

Revisiting the Robustness of PET-Based Textural Features in the Context of Multi-Centric Trials.

Directory of Open Access Journals (Sweden)

Clément Bailly

Full Text Available This study aimed to investigate the variability of textural features (TF as a function of acquisition and reconstruction parameters within the context of multi-centric trials.The robustness of 15 selected TFs were studied as a function of the number of iterations, the post-filtering level, input data noise, the reconstruction algorithm and the matrix size. A combination of several reconstruction and acquisition settings was devised to mimic multi-centric conditions. We retrospectively studied data from 26 patients enrolled in a diagnostic study that aimed to evaluate the performance of PET/CT 68Ga-DOTANOC in gastro-entero-pancreatic neuroendocrine tumors. Forty-one tumors were extracted and served as the database. The coefficient of variation (COV or the absolute deviation (for the noise study was derived and compared statistically with SUVmax and SUVmean results.The majority of investigated TFs can be used in a multi-centric context when each parameter is considered individually. The impact of voxel size and noise in the input data were predominant as only 4 TFs presented a high/intermediate robustness against SUV-based metrics (Entropy, Homogeneity, RP and ZP. When combining several reconstruction settings to mimic multi-centric conditions, most of the investigated TFs were robust enough against SUVmax except Correlation, Contrast, LGRE, LGZE and LZLGE.Considering previously published results on either reproducibility or sensitivity against delineation approach and our findings, it is feasible to consider Homogeneity, Entropy, Dissimilarity, HGRE, HGZE and ZP as relevant for being used in multi-centric trials.

A Prospective Observation Study of Medical Toxicology Consultation in a U.S. Combat Theater.

Science.gov (United States)

Maddry, Joseph K; Ng, Patrick C; Sessions, Daniel; Bebarta, Vikhyat S

2016-11-01

Since 2001, U.S. military personnel and active duty, uniformed physicians providing medical support have been deployed to Afghanistan. Medical toxicologists are among the physicians deployed. There is a paucity of information present in the literature that has documented cases treated by toxicologists in theater. This prospective observational study describes 15 male patients treated in theater by a military medical toxicologist. We performed a prospective observational study in which a medical toxicologist consulted and reported on deployed toxicology cases occurring during a 5-month deployment to Bagram, Afghanistan. Fifteen toxicology cases were collected during the 5-month period. The patients included three Afghan civilians, three U.S. civilians, and nine U.S. military personnel. Eight cases were attempts at recreational euphoria, two were self-harm attempts, two were from performance-enhancing supplements, two were accidental occupational exposures and one was alcohol withdrawal. Methanol was the most common exposure followed by dextromethorphan, supplements, opiates, and chlorine gas. In our study, we found that toxic alcohols and nonprescription medications were the most common exposures. In addition, this is the first study to describe bedside toxicology consults for U.S. combat forces in theater and the use of an observation unit for critically ill patients. Reprint & Copyright © 2016 Association of Military Surgeons of the U.S.

Demographic, clinical and antibody characteristics of patients with digital ulcers in systemic sclerosis: data from the DUO Registry

NARCIS (Netherlands)

Denton, Christopher P.; Krieg, Thomas; Guillevin, Loic; Schwierin, Barbara; Rosenberg, Daniel; Silkey, Mariabeth; Zultak, Maurice; Matucci-Cerinic, Marco; Stetter, M.; Lackner, K.; Tomi, N.; Hafner, F.; Brodmann, M.; Kuen-Spiegel, M.; Kolle, H.; Raffier, B.; Hamberger, N.; Metz, S.; Siebel, C.; Trummer, M.; Thonhofer, R.; Illmer, X.; Trautinger, F.; Schmidt, P.; Rintelen, B.; Sautner, J.; Willfort-Ehringer, A.; Margeta, C.; Monshi, B.; Pirkhammer, D.; Richter, L.; Holzer, G.; Minmair, G.; Broll, H.; Takacs, M.; Hirschl, M.; Mesaric, P.; Feldmann, R.; Semmelweis, K.; Hundstorfer, M.; Reinhart, V.; Maurer, B.; Verner, D.; Distler, O.; Schmidt-Bosshard, R.; Bohmova, J.; Prochazkova, L.; Nemec, P.; Fojtik, Z.; Soukup, T.; Smrzova, A.; Suchy, D.; Zemanova, I.; Becvar, R.; Gawlik, A.; Koch, M.; Rauen, T.; Voss, B.; Kurthen, R.; Unholzer, A.; Starz, H.; Welzel, J.; Plaumann, K.; Merk, B.; Bloching, H. H.; Moosig, F.; Frey, P.; Kahl, S.; Schleenbecker, H.; Storck-Mueller, K.; Schwarting, A.; Hazenbiller, A.; Nichelmann, V.; Flaig, W.; Rumbaur, C.; Boesenberg, I.; Schmeiser, T.; Marx, J.; Mayer, L.; Stein, T.; Ochs, W.; Rasche, C.; Worm, M.; Riemekasten, G.; Deuschle, K.; Becker, M.; Kleiner, H. J.; Schulze, K.; Tiggers, C.; Peters, J.; Kirschke, J.; Schaefer, C.; Monshausen, M.; Mengden, T.; Sadeghlar, F.; Seidel, M.; Hillebrecht, C.; Andresen, J.; Reemtsen, R.; Stoeckl, F.; Sperling, S.; Podda, M.; Wagner, N.; Guenzel, J.; Wuerzburg, I.; Luethke, K.; Enderlein, M.; Kayser, M.; Gerber, A.; Haust, M.; Hoff, N. P.; Mota, R.; Akanay-Diesel, S.; Jahnke, K.; Mettler, S.; Toeller, S.; Zwenger, S.; Klein, E.; Hahn, K.; Beyer, C.; Distler, J.; Katzemich, A.; Erfurt-berge, C.; Sticherling, M.; Schuch, F.; Rapp, P.; Mitchell, A.; Freundlieb, C.; Rushentsova, U.; Himsel, A.; Henkemeier, U.; Eilbacher, P.; Ullrich-Guenther, C.; Neul, S.; Oelsner, M.; Hermanns, G.; Fiene, M.; Gause, A.; Mensing, C.; Klings, D.; Mensing, H.; Messall, J.; Zuper, R.; May, D.; Bruckner, L.; Sheikh, N.; Aries, P.; Kirchberg, S.; Funkert, A.; Blank, N.; Lupaschko, S.; Schwuerzer-Voit, M.; Meier, L.; Herr, U.; Meier, U.; Neek, G.; Wernitzsch, H.; Pfoehler, C.; Assmann, G.; Vosswinkel, J.; Krog, B.; Wollersdorfer, E.; Oltmann-Schroeder, J.; Zeuner, R.; Uhlig, S.; Barth, S.; Huegel, R.; Glaeser, R.; Rabe, B.; Schuster, J.; Scholz, J.; Kremer, K.; Robakidze-Torbahn, M.; Moinzadeh, P.; Mittag, M.; Dohse, A.; Muhlack, A.; Schultz, L.; Schult, S.; Frambach, Y.; Kettenbach, A.; Fell, I.; Schweda, K.; Steinbrink, K.; Podobinska, M.; Harmuth, W.; Nielen, C.; Kaczmarczyk, A.; Kellner, C.; von Oelhafen, J.; von Bildering, P. B.; Kunze, S.; Niedermeier, A.; Messer, G.; Sardy, M.; Bekou, V.; Belloni, B.; Huettig, B.; Ziai, M.; Hein, R.; Hallecker, A.; Gaubitz, M.; Hallermann, C.; Schmidt, K.; Herrgott, I.; Hildebrandt, B.; Eiden, E.; Guertler, I.; Gernot Scheibl, E.; Brand, H.; Kaeding, U.; Weiss, E.; Reischel, N.; Kern, S.; Baumann, C.; Hellmich, B.; Loeffler, C.; Pflugfelder, J.; Karaenke, P.; Ruchenburg, J.; Blume, J.; Zabel, M.; Deppermann, N.; Chromik, S.; Metzler, C.; Krupp, E.; Rumpel, H.; Krause Rostock, J.-O.; Kneitz, C.; Federow, I.; Schneider, K.; Semmler, M.; Hapke, S.; Barnd, A.; Linke, M.; Kampe-Juzak, E.; Knoebel, K.; Niefanger, K.; Wilhelm, H. U.; Lauterwein, B.; Fierlbeck, G.; Schanz, S.; Pfeiffer, C.; Hassel, R.; Wahn, H.; Schildt, K.; von Elling, A.; Boro, D.; Ebel, J.; Ahmadi, K.; Moritz, D.; Dietl, S.; Dyballa, J.; Alsheimer, B.; Schuetz, N.; Schuart, T.; Mueglich, C.; Tony, H. P.; Marina, P.; Deininger, F.; Hartmann, F.; Olsen, A. B.; Sondergaard, K. H.; Naderi, Y.; Iversen, L. V.; Karlsmark, T.; Knudsen, J. B.; Gil, J. G.; Lopez, J. C. F.; Tasende, J. A. P.; Gonzales, M. F.; Sandoval, A. A.; del Carmen Torres Martin, M.; Corteguera, M.; Barca, B. A.; Montes, I. C.; de la Torre, R. G.; Victoria Egurbide, M.; Pros, A.; Munoz, J.; Simeon, C. P.; Espinosa, G.; Espinposa, G.; Rodriguez, M. A. P.; Castellvi, I.; Mascaro, J. M.; Bellido, D.; Manzanedo, V. S.; Huertas, M. P.; Sanchez, M. D. M.; Trenado, M. S. S.; Garcia, P. V.; Gines Martinez, F.; Angeles Aquirre, M.; del Rio, A. H.; Vazquez, J. L. G.; Coleman, J. V.; Lopez, M. R.; Sanchez, P. S.; Aizpuru, E. M. F.; Mateo, F. J. N.; Callejas, J. L.; Ortego, N.; Santo, M. P.; Rubio, M.; Martin, I.; Cruz, A.; Crespo, M.; Ramos, P. C.; Fernandez, A. S.-A.; Filloy, J. A. M.; Rodriguez, T. R. V.; Marhuenda, A. R.; Blanco, J. J. R.; Hernan, M. G. B.; Mendoza, A. Z.; de la Puente, C.; Rabaneda, E. V.; de Vicuna, R. G.; del Mar Ripoll Macias, M.; del la Pena Lefebvre, P. G.; de Ramon, E.; Camps, M. T.; Fernandez, C.; Miguelez, R.; Uson, J.; Delgado, E. G.; Villaverde, V.; Maceiras, F.; Cruz, J.; Mosquera, J. A.; Mera, A.; Pampin, E. P.; Blanco, J. S.; Maneiro, J. R.; Diaz, J. J.; Losada, L.; Caamano, M.; Fernandez, S.; Insua, S. A.; Laurin, C. U.; Sanchez, J.; Fernandez, N. C.; Becerra, N. D.; Garcia, A.; Nicolas, G. M.; del Carmen Ortega de la O, M.; Rueda, A.; Calvo, J.; Roman Ivorra, J.; Sancho Alegre, J. J.; Barbado, J.; Montes, J.; Saez, L.; Kaarto, A.; Makinen, H.; Madaule, S.; Dadban, A.; Lok, C.; Ferrandiz, D.; Moiton, M. P.; Magy-Bertrand, N.; Taieb, A.; Droitcourt, C.; Belin, E.; Balquiere, S.; Prey, S.; Boulon, C.; Constans, J.; Richez, C.; Sassolas, B.; Misery, L.; Greco, M.; collet, E.; Berthier, S.; Leguy-Seguin, V.; Imbert, B.; Carpentier, P.; Blaise, S.; Maillard, H.; Beneton, N.; Launay, D.; Hachulla, E.; Woijtasik, G.; Charlanne, H.; Lambert, M.; Jourdain, N.; Hatron, P. Y.; Morell, S.; Spars, A.; Couraud, A.; Doeffel-hantz, V.; Fauchais, A. L.; Vidal, E.; Goudran, G.; Bezanahary, H.; Boussely, N.; Manea, P.; Dumonteil, S.; Loustaud-ratti, V.; Hot, A.; Coppere, B.; Desmurs-Clavel, H.; Ninet, J.; Girard-Madoux, M. H.; Granel, B.; Keynote, A.; Khau van Kien, A.; Rullier, P.; Le Quellec, A.; Riviere, S.; Bessis, D.; Cohen, J. D.; Farcas, C.; Granel-brocard, F.; Agard, C.; Durant, C.; Fuzibet, J. G.; Queyrel, V.; Berezne, A.; Guillevin, L.; Mouthon, L.; Frances, C.; Toledano, C.; Cabane, J.; Tiev, K.; Farge, D.; Keshtmand, H.; Lazareth, I.; Priollet, P.; Michon-Pasturel, U.; Wipff, J.; Assous, N.; Cartry, O.; Kostrzwewa, E.; Doutre, M. S.; Blum, L.; Reguiai, Z.; Letremy, A.; Perlat, A.; Cazalets-lacoste, C.; Decaux, O.; Jego, P.; Duval-modeste, A. B.; Deboves, O.; Sordet, C.; Chatelus, E.; Chiffot, H.; Sibillia, J.; Couret, B.; Moulis, G.; Sailler, L.; Adoue, D.; Gaches, F.; Diot, E.; Skowron, F.; Zenone, T.; Quemeneur, T.; Kyndt, X.; Wahl, D.; Zuily, S.; Moline, T.; Bravetti, V.; Galanopoulos, N.; Vasilopoulos, D.; Vlachoyannopoulos, P.; Kritikos, I.; Tsifetaki, N.; Koutroumbas, A.; Garyfallos, A.; Athanassiou, P.; Aslanidis, S.; Kamali, S.; Dimitroulas, T.; Galanopoulo, V.; Elezoglou, A.; Grier, A.; Murray, M.; O'Rourke, M.; Gabrielli, A.; Lapadula, G.; Serafino, L.; Terlizzi, N.; Bellissimo, S.; Stisi, S.; Malavolta, N.; Airo, P.; Vacca, A.; Battaglia, E.; Foti, R.; Mazzuca, S.; Bortoluzzi, A.; Trotta, F.; Galluccio, F.; Marucci, A.; Cantatore, F.; Bucci, R.; Puppo, F.; de Angeli, R.; Grassi, W.; Cipriani, P.; Mazzone, A.; Faggioli, P.; Severino, A.; Scorza, R.; Belloli, L.; Ughi, N.; Antivalle, M.; del Papa, N.; Maglione, W.; Zeni, S.; Ferri, C.; Colaci, M.; Varcasia, G.; Cuomo, G.; Cozzi, F.; Triolo, G.; Gatti, S.; Montecucco, C. M.; Doveri, M.; Nigro, A.; Olivieri, I.; Bajoochi, G.; Rosato, E.; Salsano, F.; Faustini, F.; Ferraccioli, G.; Colonna, L.; Pallotta, S.; Riccieri, V.; Mussi, A.; Bellisai, F.; Galeazzi, M.; Fusaro, E.; Saracco, M.; Pellerito, R.; Masolini, P.; de Vita, S.; Lombardi, S.; Lunardi, C.; Moolenburgh, J. D.; Heurkens, A. H. M.; Voskuyl, A.; Hak, A. E.; Stroes, E. S. K.; Remans, J.; Gerdes, V.; van Woerkom, J. M.; de Long, A. J. L.; Kaasjager, H. A. H.; Visser, H.; Janssen, M.; van Guldener, C.; van Neer, F.; Vos, P.; Peters, A. J.; Hulsmans, H.; Ronday, K.; Goekoop, R.; Ewals, J.; Valentijn, R.; de Bois, M.; Westedt, M. L.; Siewertsz van Reesema, D.; Knifjj-Dutmer, E.; Stolk, J. N.; Willems, H.; Kuiper-geertsma, D. G.; Baudaoin, P.; Fretter, P.; Westra, R.; Sonnaville, P. B. J.; Smit, A.; Bootsma, H.; Brouwer, L.; Bijl, M.; Molders, N.; Lebrun, C.; van der Veen, M. J.; Noordzij, M.; Houben, H.; Landewe, R. M. B.; Vercoutere, W.; Jahangier de Veen, Z. N.; Zijlstra, T. R.; Ubels, F.; Bruyn, G.; Jansen, P.; Schuerwegh, A.; Huizinga, T. W. J.; Paassen, P.; Hurkens, T.; Geurts, M.; van den Hoogen, F.; Vonk, M.; Jacobs, P. J. C.; Groenendael, J. H. L. M.; Seys, P.; van Zeben, D.; van Paassen, H.; Groenendael, J.; Han, K. H.; Wlarvens, M.; van Hagen, M.; van Daele, P.; Dolhain, R.; Gerards, A. H.; van der Lubbe, P.; Kanter, M. D. E.; Muller, W. H.; Ton, E.; van Krugten, M.; van Gameren, I.; Lanting, P.; den Hengst, C.; Gjessdal, C. G.; Hjertaker, S. L.; Madland, T. M.; Bendvold, A.; Bitter, H.; Hoffmann-Vold, A. M.; Midtvedt, O.; Bakland, G.; Aslkaksen, H. K.; Seip, M.; Kalstad, S.; Koldingsnes, W.; Grandauent, B.; Nordvag, B. Y.; Stran, E. K.; Skomsvoll, J.; Andersen, M.; Thomsen, R. S.; Pedersen, T.; Bakkeheim, V.; Cordeiro, A.; Alves, J.; Oliveira, S.; Coelho, P.; Resende, C.; Ponte, C.; Almeida, I.; Silva, I.; Santos, C.; Camara, I.; Costa, J.; Hellstrom, H.; Mohammad, A.; Lind, I.; Lind, K.; Bracin, T.; Liljequist, E.; Vingren, T.; Ostenson, A.; Hermansson, E.; Thorsson, C.; Soderlin, M.; Nordin, A.; Waldheim, E.; Vengemyr, K.; Albertsson, K.; Karlsson, M. L.; Rydvald, Y.; Rizk, M.; Dolnicar, A. S.; Lukac, J.; James, J.; McHugh, N.; Cole, S.; Brown, S.; Hamilton, A.; Faizal, A.; Hall, F.; Murphy, K.; Skingle, S.; Harris, H.; Madhok, F.; Hampson, R.; Baguley, E.; Ogunbambi G, O.; Lamb, J.; Anderson, M.; Moots, R.; White-Alao, B.; Morrison, C.; Dobson, J.; Gordon, P.; Salerno, R.; Denton, C.; Parker, L.; Ochiel, R.; Vincent, R.; Zimba, S.; Ngcozana, T.; Xu, Y.; D'Cruz, D.; Choong, L. M.; Herrick, A.; Wragg, E.; Manning, J.; Moore, T.; Kelsey, C.; Chakravarty, K.; Skyes, H.; Athiveer, P.

2012-01-01

The Digital Ulcers Outcome (DUO) Registry was designed to describe the clinical and antibody characteristics, disease course and outcomes of patients with digital ulcers associated with systemic sclerosis (SSc). The DUO Registry is a European, prospective, multicentre, observational, registry of SSc

Safety and tolerability of prolonged-release nicotinic acid in statin-treated patients

NARCIS (Netherlands)

Birjmohun, R. S.; Kastelein, J. J. P.; Poldermans, D.; Stroes, E. S. G.; Hostalek, U.; Assmann, G.

2007-01-01

Objective: To evaluate the safety and tolerability of prolonged -release nicotinic acid (Niaspan*) added to statin therapy in patients at increased cardiovascular risk. Methods: This was a 6-month, prospective, observational, multicentre, open-label evaluation of prolonged-release nicotinic acid

Data collection using open access technology in multicentre operational research involving patient interviews.

Science.gov (United States)

Shewade, H D; Chadha, S S; Gupta, V; Tripathy, J P; Satyanarayana, S; Sagili, K; Mohanty, S; Bera, O P; Pandey, P; Rajeswaran, P; Jayaraman, G; Santhappan, A; Bajpai, U N; Mamatha, A M; Maiser, R; Naqvi, A J; Pandurangan, S; Nath, S; Ghule, V H; Das, A; Prasad, B M; Biswas, M; Singh, G; Mallick, G; Jeyakumar Jaisingh, A J; Rao, R; Kumar, A M V

2017-03-21

Conducting multicentre operational research is challenging due to issues related to the logistics of travel, training, supervision, monitoring and troubleshooting support. This is even more burdensome in resource-constrained settings and if the research includes patient interviews. In this article, we describe an innovative model that uses open access tools such as Dropbox, TeamViewer and CamScanner for efficient, quality-assured data collection in an ongoing multicentre operational research study involving record review and patient interviews. The tools used for data collection have been shared for adaptation and use by other researchers.

Can the cerebroplacental ratio (CPR) predict intrapartum fetal compromise? : a prospective observational study

OpenAIRE

Page, Ann-Sophie; Page, Geert; Dehaene, Isabelle; Roets, Ellen; Roelens, Kristien

2017-01-01

Objective: To investigate the potential clinical use of serial fetal CPR measurements during the last month of pregnancy for the prediction of adverse perinatal outcome in unselected low-risk pregnancies. Methods: A multicenter prospective observational cohort study in 315 consecutively recruited low-risk pregnancies. All eligible pregnancies underwent serial sonographic evaluation of fetal weight and Doppler indices at two week intervals, from 36 weeks gestation until delivery. Data were ...

Cancer incidence and survival in Lynch syndrome patients receiving colonoscopic and gynaecological surveillance: first report from the prospective Lynch syndrome database

OpenAIRE

Moller, Pal; Seppala, Toni; Bernstein, Inge; Holinski-Feder, Elke; Sala, Paola; Evans, D. Gareth; Lindblom, Annika; Macrae, Finlay; Blanco, Ignacio; Sijmons, Rolf; Jeffries, Jacqueline; Vasen, Hans; Burn, John; Nakken, Sigve; Hovig, Eivind

2017-01-01

Objective Estimates of cancer risk and the effects of surveillance in Lynch syndrome have been subject to bias, partly through reliance on retrospective studies. We sought to establish more robust estimates in patients undergoing prospective cancer surveillance.\\ud \\ud Design We undertook a multicentre study of patients carrying Lynch syndrome-associated mutations affecting MLH1, MSH2, MSH6 or PMS2. Standardised information on surveillance, cancers and outcomes were collated in an Oracle rela...

Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial.

Science.gov (United States)

Scholz, Karl Heinrich; Maier, Sebastian K G; Maier, Lars S; Lengenfelder, Björn; Jacobshagen, Claudius; Jung, Jens; Fleischmann, Claus; Werner, Gerald S; Olbrich, Hans G; Ott, Rainer; Mudra, Harald; Seidl, Karlheinz; Schulze, P Christian; Weiss, Christian; Haimerl, Josef; Friede, Tim; Meyer, Thomas

2018-04-01

The aim of this study was to investigate the effect of contact-to-balloon time on mortality in ST-segment elevation myocardial infarction (STEMI) patients with and without haemodynamic instability. Using data from the prospective, multicentre Feedback Intervention and Treatment Times in ST-Elevation Myocardial Infarction (FITT-STEMI) trial, we assessed the prognostic relevance of first medical contact-to-balloon time in n = 12 675 STEMI patients who used emergency medical service transportation and were treated with primary percutaneous coronary intervention (PCI). Patients were stratified by cardiogenic shock (CS) and out-of-hospital cardiac arrest (OHCA). For patients treated within 60 to 180 min from the first medical contact, we found a nearly linear relationship between contact-to-balloon times and mortality in all four STEMI groups. In CS patients with no OHCA, every 10-min treatment delay resulted in 3.31 additional deaths in 100 PCI-treated patients. This treatment delay-related increase in mortality was significantly higher as compared to the two groups of OHCA patients with shock (2.09) and without shock (1.34), as well as to haemodynamically stable patients (0.34, P < 0.0001). In patients with CS, the time elapsing from the first medical contact to primary PCI is a strong predictor of an adverse outcome. This patient group benefitted most from immediate PCI treatment, hence special efforts to shorten contact-to-balloon time should be applied in particular to these high-risk STEMI patients. NCT00794001.

The Se.Ko.Ph. study: a European multicentre study on falls in elderly subjects living in residential homes

Directory of Open Access Journals (Sweden)

Aladar Bruno Ianes

2017-05-01

Full Text Available The aim was to investigate risk factors for falls in elderly people living in residential nursing homes. An observational, prospective, multicentre study was conducted between March 2010 and March 2011 investigating falls in elderly residents living in residential nursing homes (4 Italian¸ 4 French and 5 German nursing homes. A number of risk factors were assessed as well as details of the fall (dynamics, reasons, location and time of occurrence. Differences were observed between the countries related to different nursing practices. Fallers comprised 36.5% of all residents and approximately 40% were injured as a consequence. Six logistic regression models were created to assess which fallrelated variables had the most impact, and showed subjects with faecal incontinence had a lower risk of falling, while subjects afflicted with dementia and visual impairment showed an increased risk of falling. Higher Tinetti scores were found to be related to an increased fall risk. Falls in the elderly occur due to complex interactions between demographic, physical, behavioural and environmental risk factors. Differences between countries in fall rates were seen, probably due to different medical practices, use of aids and restraints, and characteristics of the populations (i.e. the Italian residents tended to be more cognitively impaired and more impaired in balance and gait compared to the French and German residents. There was evidence that subjects with a better clinical status fall more frequently, whereas non-fallers had a worse clinical status and therefore tended to be more bedridden.

Multicentric lymphoma in a giant anteater (Myrmecophaga tridactyla).

Science.gov (United States)

Sanches, Adrien W D; Werner, Pedro R; Margarido, Tereza C C; Pachaly, Jose R

2013-03-01

Neoplastic disease is not well documented in giant anteaters. This report describes a disseminated lymphoma in an adult male giant anteater (Myrmecophaga tridactyla) from the City Zoo of Curitiba, State of Paraná, Brazil. No clinical signs were noticed before its death, except for a slight inappetence. At postmortem examination, pale white to yellow, variably sized nodules infiltrated the heart, liver, and intestinal lymph nodes. Histologically, two distinct cell populations were present in the nodular lesions: one characterized by smaller cells, primarily lymphocytic in nature, and another characterized by larger rounded cells with loose chromatin and frequently indented nuclei resembling histiocytes. Giant binucleated cells were occasionally observed. Mitotic figures numbered 2-3 mitotic figures/x400 field. Both cellular populations presented with moderate pleomorphism, large nuclei, a high nucleus-to-cytoplasm ratio, distinct nucleoli, and coarse nuclear chromatin. The neoplasia was classified as a form of multicentric lymphohistiocytic lymphoma (Rappaport Classification) and as an intermediate grade lymphoma (National Cancer Institute Working Formulation).

[Multicentric hyaline vascular Castleman's disease. A POEMS type variant].

Science.gov (United States)

Gracia-Ramos, Abraham Edgar; Cruz-Domínguez, María del Pilar; Vera-Lastra, Olga Lidia

2013-01-01

Castleman's disease is an atypical lymphoproliferative disorder which may be compatible with paraneoplastic manifestations of POEMS syndrome. a 53 year old man with a history of type 2 diabetes, hypothyroidism and Addison's disease presented with numbness and weakness in limbs, dyspnea, skin hardening, Raynaud's phenomenon, weight loss and fatigue. A physical exam showed tachypnea, generalized cutaneous hyperpigmentation and skin hardening of extremities, muscle weakness, hypoesthesia and hyporeflexia. Laboratory showed hyperprolactinemia, low testosterone, hypothyroidism and Addison's disease. Electrophoresis of proteins showed polyclonal hypergammaglobulinemia. Somatosensory evoked potentials reported peripheral neuropathy and severe axonal polyneuropathy by electromyography. Chest X-rays showed bilateral reticular infiltrates and mediastinal widening. An echocardiogram displayed moderate pulmonary hypertension. Skin biopsy had no evidence of scleroderma. CT reported axillar, mediastinal and retroperitoneal nodes. The mediastinal lesion biopsy reported hyaline vascular Castleman's disease, multicentric variety. He was treated with rituximab. the case meet criteria for multicentric hyaline vascular Castleman's disease, POEMS variant, treated with rituximab.

Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content.

Science.gov (United States)

Lo, William B; McAuley, Ciaran P; Gillies, Martin J; Grover, Patrick J; Pereira, Erlick A C

2017-11-01

Prospective, multi-centre, multi-specialty medical notes review and patient interview. The consenting process is an important communication tool which also carries medico-legal implications. While written consent is a pre-requisite before spinal surgery in the UK, the standard and effectiveness of the process have not been assessed previously. This study assesses standard of written consent for elective lumbar decompressive surgery for degenerative disc disease across different regions and specialties in the UK; level of patient recall of the consent content; and identifies factors which affect patient recall. Consent forms of 153 in-patients from 4 centres a, b, c, d were reviewed. Written documentation of intended benefits, alternative treatments and operative risks was assessed. Of them, 108 patients were interviewed within 24 h before or after surgeries to assess recall. The written documentation rates of the operative risks showed significant inter-centre variations in haemorrhage and sphincter disturbance (P = 0.000), but not for others. Analysis of pooled data showed variations in written documentation of risks (P recall of these risks, there was no inter-centre variation. Patients' recall of paralysis as a risk was highest (50.9%) and that of recurrence was lowest (6.5%). Patients recalled risks better than those ≥65, significantly so for infection (29.9 vs 9.7%, P = 0.027). Patients consented >14 days compared to recall for paralysis (65.2 vs 43.7%) and recurrence (17.4 vs 2.8%). Patient recall was independent of consenter grade. Overall, the standard of written consent for elective lumbar spinal decompressive surgery was sub-optimal, which was partly reflected in the poor patient recall. While consenter seniority did not affect patient recall, younger age and longer consent-to-surgery time improved it.

Synchronous multicentric osteosarcoma: the case for metastases

International Nuclear Information System (INIS)

Daffner, R.H.; Kennedy, S.L.; Fox, K.R.; Crowley, J.J.; Sauser, D.D.; Cooperstein, L.A.

1997-01-01

Objective. There is a current debate whether multicentric osteosarcoma represents synchronous multiple primary osteosarcomas or metastatic disease. The purpose of this report is to evaluate the etiology, presentation, and classification of this entity. Design and patients. Six patients ranging in age from 7 to 29 years were studied. The clinical, radiographic, and pathologic findings are reported. In addition, a review of the literature was undertaken. Results. The clinical courses of our six patients as well as a review of the literature suggest that multicentric osteosarcoma represent one extreme of a continuous scale of metastatic osteosarcoma rather than multiple synchronous primary tumors. The presentation is unusual and the clinical behavior distinctive, but the mechanism of spread remains the same: blood-borne and lymphatic-borne. Conclusions. Our experience with these six patients supports the concept in the recent literature that synchronous osteosarcoma is one extreme of the spectrum of metastatic osteosarcoma. Its unique features are: (1) multiple radiodense lesions that present simultaneously with or without pulmonary metastases; (2) a single ''dominant'' lesion with multiple smaller lesions; and (3) a uniformly rapid, fatal prognosis. Osteosarcoma should be regarded as a metastatic disease, even when only a single primary lesion is found at the initial presentation. (orig.)

Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial

Science.gov (United States)

Forestier, R; Desfour, H; Tessier, J-M; Françon, A; Foote, A M; Genty, C; Rolland, C; Roques, C-F; Bosson, J-L

2010-01-01

Objective To determine whether spa therapy, plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment, in the management of knee osteoarthritis. Methods Large multicentre randomised prospective clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria, attending French spa resorts as outpatients between June 2006 and April 2007. Zelen randomisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating. The main endpoint criteria were patient self-assessed. All patients continued usual treatments and performed daily standardised home exercises. The spa therapy group also received 18 days of spa therapy (massages, showers, mud and pool sessions). Main Endpoint The number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery. Results The intention to treat analysis included 187 controls and 195 spa therapy patients. At 6 months, 99/195 (50.8%) spa group patients had MCII and 68/187 (36.4%) controls (χ2=8.05; df=1; p=0.005). However, no improvement in quality of life (Short Form 36) or patient acceptable symptom state was observed at 6 months. Conclusion For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone, and is well tolerated. Trial registration number NCT00348777. PMID:19734131

Intrauterine temperature during intrapartum amnioinfusion: a prospective observational study.

Science.gov (United States)

Tomlinson, T M; Schaecher, C; Sadovsky, Y; Gross, G

2012-07-01

To determine the influence of routine intrapartum amnioinfusion (AI) on intrauterine temperature. Prospective observational study. Maternity unit, Barnes Jewish Hospital, St Louis, MO, USA. Forty women with singleton gestations and an indication for intrapartum intrauterine pressure catheter placement. Using a temperature probe, we digitally recorded intrauterine temperature every 10 minutes during labour. Amnioinfusion was administered according to a standard protocol using saline equilibrated to the ambient temperature. Mean intrauterine temperature during labour. Participants were monitored for a mean of 280 minutes (range 20-820). A total of 164 intrauterine temperature readings in the AI cohort were compared with 797 control measurements. When compared with controls, we observed a lower intrauterine temperature in the AI cohort (36.4 versus 37.4°C, P<0.01). More measurements in the AI cohort were recorded in the presence of intrapartum fever (40% versus 30%). A subgroup analysis of measurements recorded in afebrile parturients revealed an even greater effect of AI (1.5°C decrease, 37.3 versus 35.8°C, P<0.01). Routine intrapartum AI using saline equilibrated to a mean ambient temperature of 25.0°C reduces intrauterine temperature and may thereby affect fetal core temperature. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

Synchronous Multicentric Giant Cell Tumour of Distal Radius and Sacrum with Pulmonary Metastases

Directory of Open Access Journals (Sweden)

Varun Sharma Tandra

2015-01-01

Full Text Available Giant cell tumour (GCT is an uncommon primary bone tumour, and its multicentric presentation is exceedingly rare. We report a case of a 45-year-old female who presented to us with GCT of left distal radius. On the skeletal survey, osteolytic lesion was noted in her right sacral ala. Biopsy confirmed both lesions as GCT. Pulmonary metastasis was also present. Resection-reconstruction arthroplasty for distal radius and thorough curettage and bone grafting of the sacral lesion were done. Multicentric GCT involving distal radius and sacrum with primary sacral involvement is not reported so far to our knowledge.

Assessment of quality of life and functional outcome in patients sustaining moderate and major trauma: a multicentre, prospective cohort study.

Science.gov (United States)

Rainer, T H; Yeung, J H H; Cheung, S K C; Yuen, Y K Y; Poon, W S; Ho, H F; Kam, C W; Cattermole, G N; Chang, A; So, F L; Graham, C A

2014-05-01

Trauma care systems aim to reduce both death and disability, yet there is little data on post-trauma health status and functional outcome. To evaluate baseline, discharge, six month and 12 month post-trauma quality of life, functional outcome and predictors of quality of life in Hong Kong. Multicentre, prospective cohort study using data from the trauma registries of three regional trauma centres in Hong Kong. Trauma patients with an ISS≥9 and aged≥18 years were included. The main outcome measures were the physical component summary (PCS) score and mental component summary (MCS) scores of the Short-Form 36 (SF36) for health status, and the extended Glasgow Outcome Scale (GOSE) for functional outcome. Between 1 January 2010 and 31 September 2010, 400 patients (mean age 53.3 years; range 18-106; 69.5% male) were recruited to the study. There were no statistically significant differences in baseline characteristics between responders (N=177) and surviving non-responders (N=163). However, there were significant differences between these groups and the group of patients who died (N=60). Only 16/400 (4%) cases reported a GOSE≥7. 62/400 (15.5%) responders reached the HK population norm for PCS. 125/400 (31%) responders reached the HK population norm for MCS. If non-responders had similar outcomes to responders, then the percentages for GOSE≥7 would rise from 4% to 8%, for PCS from 15.5% to 30%, and for MCS from 31% to 60%. Univariate analysis showed that 12-month poor quality of life was significantly associated with age>65 years (OR 4.77), male gender (OR 0.44), pre-injury health problems (OR 2.30), admission to ICU (OR 2.15), ISS score 26-40 (OR 3.72), baseline PCS (OR 0.89), one-month PCS (OR 0.89), one-month MCS (OR 0.97), 6-month PCS (OR 0.76) and 6-month MCS (OR 0.97). For patients sustaining moderate or major trauma in Hong Kong at 12 months after injury<1 in 10 patients had an excellent recovery, ≤3 in 10 reached a physical health status score�

Intra- and interobserver analysis in the morphological assessment of early stage embryos during an IVF procedure: a multicentre study

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Devroe Johanna

2011-09-01

Full Text Available Abstract Background Quality control programs are necessary to maintain good clinical practice. Embryo grading has been described as one of the external quality assurance schemes. Although the evaluation of embryos is based on the assessment of morphological characteristics, considerable intra- and inter-observer variability has been described. In this multicentre study, the variability in the embryo evaluation has been evaluated using morphological characteristics on day 1, day 2 and day 3 of embryo development. Methods Five embryologists of four different IVF centers participated in this study. Multilevel images of embryos were presented on a website at different time points to evaluate intra-and inter-observer agreement in the assessment of embryo morphology. The embryos were evaluated on day 1, day 2 and day 3 of their development and each embryologist had to decide if the embryo had to be transferred, cryopreserved or discarded. Results Both intra-observer agreement and inter-observer agreement were good to excellent for the position of the pronuclei on day 1, the number of blastomeres on day 2 and day 3 and the clinical decision (transfer, cryopreservation, discard. For all other characteristics (size of pronuclei, presence of cytoplasomic halo, degree of fragmentation and size of blastomeres the intra- and inter-observer agreement was moderate to very poor. Conclusions Mono- or multicentre quality control on embryo scoring by morphological assessment can easily be performed through the design of a simple website. In the future the website design can be adapted to generate statistical feedback upon scoring and can even include a training module.

Psoriasis increases risk of new-onset atrial fibrillation: a systematic review and meta-analysis of prospective observational studies.

Science.gov (United States)

Upala, Sikarin; Shahnawaz, Afeefa; Sanguankeo, Anawin

2017-08-01

Psoriasis is a common chronic immune-mediated dermatological disease that increases the risk of cardiovascular disease. We conducted a systematic review and meta-analysis to evaluate the association between psoriasis and atrial fibrillation from prospective observational studies. A comprehensive search of the databases of the MEDLINE and EMBASE was performed from inception through November 2015. The inclusion criterion was the prospective observational study that assessed the risk of new-onset atrial fibrillation in adults with psoriasis. Outcome was the adjusted hazard ratio (HR) of atrial fibrillation comparison between patients with psoriasis and controls. Pooled HR and 95% confidence intervals (CI) were calculated using a random-effects model. The initial search yielded 176 articles. Fifteen articles underwent full-length review and data were extracted from 4 observational studies. Incidence of atrial fibrillation was ascertained by cardiologist-reviewed electrocardiograms. There was a significant increased risk of new-onset atrial fibrillation in patients with psoriasis compared to controls with a pooled HR 1.42 (95%CI 1.22-1.65). Our meta-analysis of prospective studies demonstrated that patients with psoriasis have increased risk of new-onset atrial fibrillation. Future interventional studies addressing the impact of psoriasis treatment and prevention of atrial fibrillation should be performed.

Authorship issues in multi-centre clinical trials: the importance of making an authorship contract.

Science.gov (United States)

Rosenberg, Jacob; Burcharth, Jakob; Pommergaard, Hans-Christian; Vinther, Siri

2015-02-01

Discussions about authorship often arise in multi-centre clinical trials. Such trials may involve up to hundreds of contributors of whom some will eventually co-author the final publication. It is, however, often impossible to involve all contributors in the manuscript process sufficiently for them to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference to the original source.

International Study on Syncope of Uncertain Etiology 2: the management of patients with suspected or certain neurally mediated syncope after the initial evaluation Rationale and study design

NARCIS (Netherlands)

Brignole, M.; Sutton, R.; Menozzi, C.; Moya, A.; Garcia-Civera, R.; Benditt, D.; Vardas, P.; Wieling, W.; Andresen, D.; Migliorini, R.; Hollinworth, D.

2003-01-01

Study design Multi-centre, prospective observational study Objectives Main objective is to verify the value of implantable loop recorder (ILR) in assessing the mechanism of syncope and the efficacy of the ILR-guided therapy after syncope recurrence. Inclusion criteria Patients who met the following

Precision of 3.0 Tesla quantitative magnetic resonance imaging of cartilage morphology in a multicentre clinical trial.

Science.gov (United States)

Eckstein, F; Buck, R J; Burstein, D; Charles, H C; Crim, J; Hudelmaier, M; Hunter, D J; Hutchins, G; Jackson, C; Kraus, V Byers; Lane, N E; Link, T M; Majumdar, L S; Mazzuca, S; Prasad, P V; Schnitzer, T J; Taljanovic, M S; Vaz, A; Wyman, B; Le Graverand, M-P Hellio

2008-12-01

Quantitative MRI (qMRI) of cartilage morphology is a promising tool for disease-modifying osteoarthritis drug (DMOAD) development. Recent studies at single sites have indicated that measurements at 3.0 Tesla (T) are more reproducible (precise) than those at 1.5 T. Precision errors and stability in multicentre studies with imaging equipment from various vendors have, however, not yet been evaluated. A total of 158 female participants (97 Kellgren and Lawrence grade (KLG) 0, 31 KLG 2 and 30 KLG 3) were imaged at 7 clinical centres using Siemens Magnetom Trio and GE Signa Excite magnets. Double oblique coronal acquisitions were obtained at baseline and at 3 months, using water excitation spoiled gradient echo sequences (1.0x0.31x0.31 mm3 resolution). Segmentation of femorotibial cartilage morphology was performed using proprietary software (Chondrometrics GmbH, Ainring, Germany). The precision error (root mean square coefficient of variation (RMS CV)%) for cartilage thickness/volume measurements ranged from 2.1%/2.4% (medial tibia) to 2.9%/3.3% (lateral weight-bearing femoral condyle) across all participants. No significant differences in precision errors were observed between KLGs, imaging sites, or scanner manufacturers/types. Mean differences between baseline and 3 months ranged from <0.1% (non-significant) in the medial to 0.94% (p<0.01) in the lateral femorotibial compartment, and were 0.33% (p<0.02) for the total femorotibial subchondral bone area. qMRI performed at 3.0 T provides highly reproducible measurements of cartilage morphology in multicentre clinical trials with equipment from different vendors. The technology thus appears sufficiently robust to be recommended for large-scale multicentre trials.

Socio-demographic and clinical determinants of self-care in adults with type 2 diabetes: a multicentre observational study.

Science.gov (United States)

Ausili, Davide; Rossi, Emanuela; Rebora, Paola; Luciani, Michela; Tonoli, Luca; Ballerini, Enrico; Androni, Silvia; Vellone, Ercole; Riegel, Barbara; Di Mauro, Stefania

2018-04-05

To describe self-care as defined by the Middle Range Theory of Self-Care of Chronic Illness and to identify clinical and socio-demographic determinants in a T2DM population. A multicentre observational cross-sectional study was conducted involving 540 adults with a confirmed diagnosis of T2DM from six outpatient diabetes services in Italy. Socio-demographic and clinical data were collected from medical records. The Self-Care of Diabetes Inventory (SCODI) was used to measure self-care maintenance, monitoring, management, and confidence dimensions. For each separate scale, scores were standardized 0-100 with higher SCODI scores indicating better self-care; a score ≥ 70 is adequate. Multiple quantile regression models were performed to identify determinants of each self-care dimension. Self-care maintenance (median = 81.3) and self-care confidence (median = 79.5) were adequate in most of the subjects. Self-care monitoring was adequate in only half of the sample (median = 70.6). Self-care management was poor (median = 59.4). Lower self-care maintenance was associated with lower self-care confidence (p self-care monitoring was associated with being male (p self-care confidence (p diabetes for self-care management was associated with being male (p = 0.002), being older (p = 0.005), having a low income (p = 0.030), being employed (p = 0.008), having missed diabetes education in the last year (p = 0.002), and lower self-care confidence (p self-care confidence was associated with having diabetes for self-care maintenance, monitoring, management and confidence include both clinical and socio-demographic variables. Modifiable determinants such as self-care confidence and diabetes self-care management education could be used to tailor interventions to improve diabetes self-care.

EBV+ HHV-8+ Multicentric Castleman Disease With Plasmablastic Aggregates in an HIV+ Man: An Evolving Clinicopathologic Entity.

Science.gov (United States)

Shivane, Aditya; Pearce, Amy; Khatib, Nadia; Smith, Mark E F

2018-06-01

We report a case of EBV+ and HHV-8+ multicentric Castleman disease with plasmablastic aggregates in an HIV-positive individual. A 41-year-old man presented in early 2015 with fevers, sweats, weight loss, intractable itching, and on subsequent testing was found to be HIV positive. Investigations showed cervical lymphadenopathy and splenomegaly. He was treated for HIV and his symptoms resolved. His symptoms recurred in January 2016, and a provisional diagnosis of multicentric Castleman disease was entertained. The HHV-8 (human herpesvirus-8) and EBV (Epstein-Barr virus) viral load was elevated. A left supraclavicular lymph node core biopsy was performed, which showed features of multicentric Castleman disease with plasmablastic aggregates that are EBV (EBER) and HHV-8 positive. He responded well to rituximab treatment and remains well with no symptoms at recent follow-up.

Barriers and facilitators experienced in collaborative prospective research in orthopaedic oncology

DEFF Research Database (Denmark)

Rendon, J S; Swinton, M; Bernthal, N

2017-01-01

by orthopaedic oncological surgeons involved or interested in prospective multicentre collaboration. METHODS: All surgeons who were involved, or had expressed an interest, in the ongoing Prophylactic Antibiotic Regimens in Tumour Surgery (PARITY) trial were invited to participate in a focus group to discuss......: The 13 surgeons who participated in the discussion represented orthopaedic oncology practices from seven countries (Argentina, Brazil, Italy, Spain, Denmark, United States and Canada). Four categories and associated themes emerged from the discussion: the need for collaboration in the field...... of orthopaedic oncology due to the rarity of the tumours and the need for high level evidence to guide treatment; motivational factors for participating in collaborative research including establishing proof of principle, learning opportunity, answering a relevant research question and being part...

HIV-associated multicentric Castleman’s disease

Directory of Open Access Journals (Sweden)

Fauzia de Fátima Naime

2012-09-01

Full Text Available Multicentric Castleman’s disease (MCD is a rare lymphoproliferative disorder. It is found with higher frequency in patients with HIV infection, with systemic symptoms and poor prognosis. We present the case of a 32-year old man with HIV disease, Kaposi’s sarcoma, lymphadenopathy, fever and hemolytic anemia. A diagnosis of Castleman’s disease is confirmed through biopsy and treatment is often based only on published case reports. Systemic treatments for MCD have included chemotherapy, anti-herpes virus, highly active antiretroviral therapy and, more recently, monoclonal antibodies against both IL6 and CD20.

Unilateral pallidotomy in Parkinson's disease : a randomised, single-blind, multicentre trial

NARCIS (Netherlands)

de Bie, RMA; de Haan, RJ; Nijssen, PCG; Rutgers, AWF; Beute, GN; Haaxma, R; Schmand, B; Staal, MJ; Speelman, J.D.

1999-01-01

Background The results of several cohort studies suggest that patients with advanced Parkinson's disease would benefit from unilateral pallidotomy. We have assessed the efficacy of unilateral pallidotomy in a randomised, single-blind, multicentre trial. Methods We enrolled 37 patients with advanced

Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

Science.gov (United States)

Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

2018-05-01

The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Obstetric risk indicators for labour dystocia in nulliparous women: A multi-centre cohort study

Science.gov (United States)

Kjærgaard, Hanne; Olsen, Jørn; Ottesen, Bent; Nyberg, Per; Dykes, Anna-Karin

2008-01-01

Background In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. Methods A multi-centre population based cohort study with prospectively collected data from 2810 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix dystocia. Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern. PMID:18837972

Obstetric risk indicators for labour dystocia in nulliparous women: A multi-centre cohort study

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Ottesen Bent

2008-10-01

Full Text Available Abstract Background In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. Methods A multi-centre population based cohort study with prospectively collected data from 2810 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR and 95% confidence intervals (CI are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI: dilatation of cervix Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern.

A multi-centre, prospective, clinical in-market evaluation to assess the performance of Opsite™ Post-Op Visible dressings.

LENUS (Irish Health Repository)

O'Brien, Gillian

2010-10-01

The aim of this study was to assess the performance of Opsite™ Post-Op Visible as a post-surgical dressing in a typical clinical setting. In this multi-centre clinical evaluation, patients who underwent clean surgery were treated with Opsite Post-Op Visible dressing. Duration of dressing wear, visibility through the dressing and ability to handle exudate were assessed and the product was rated in comparison with those normally used. A total of 64 patients were recruited. Mean wear time was 4·5 days. Exudate management was rated very good or good at 96% of assessments. Visibility of the incision site was rated as very good or good at 72%, and as acceptable at 24%, of assessments. Patient comfort was rated very comfortable (63%) or comfortable (37%) at all assessments. Dressings were generally rated as satisfactory or exceeding expectations with clinicians stating that the Opsite Post-Op Visible dressing was better than the dressing they routinely used for 92% of patients. Opsite Post-Op Visible dressing is an innovative dressing combining good visibility with exudate management and patient comfort. It was found to have adequate wear time, visibility and exudate management properties making it suitable for use on a variety of surgical incision sites.

Prospective observational study of adverse drug reactions to diclofenac in children

Science.gov (United States)

Standing, Joseph F; Ooi, Kuan; Keady, Simon; Howard, Richard F; Savage, Imogen; Wong, Ian C K

2009-01-01

AIM The aim of this study was to investigate the type of common (occurring in >1% of patients) adverse reactions caused by diclofenac when given to children for acute pain. METHODS A prospective observational study was undertaken on paediatric surgical patents aged ≤12 years at Great Ormond Street and University College London Hospitals. All adverse events were recorded, and causality assessment used to judge the likelihood of them being due to diclofenac. Prospective recruitment meant not all patients were prescribed diclofenac, allowing an analysis of utilization. Causality of all serious adverse events was reviewed by an expert panel. RESULTS Children prescribed diclofenac were significantly older, and stayed in hospital for shorter periods than those who were not. Diclofenac was not avoided in asthmatic patients. Data on 380 children showed they suffer similar types of nonserious adverse reactions to adults. The incidence (95% confidence interval) of rash was 0.8% (0.016, 2.3); minor central nervous system disturbance 0.5% (0.06, 1.9); rectal irritation with suppositories 0.3% (0.009, 1.9); and diarrhoea 0.3% (0.007, 1.5). No serious adverse event was judged to be caused by diclofenac, meaning the incidence of serious adverse reactions to diclofenac in children is Children given diclofenac for acute pain appeared to suffer similar types of adverse reactions to adults; the incidence of serious adverse reaction is <0.8%. PMID:19694745

Case report 375: Multicentric reticulohistiocytosis

International Nuclear Information System (INIS)

Scutellari, P.N.; Orzincolo, C.; Trotta, F.

1986-01-01

In summary, a case of multicentric reticulohistiocytosis in an 18-year-old girl is presented, with dramatic demonstration of the progressive lesions of the hands demonstrated in xeroradiographs. The association of nodules in the skin, particularly around the distal interphalangeal joints of the hands is stressed and the generally progressive nature of the disorder is emphasized and illustrated in this patient. The end result in most instances is that of an 'arthritis mutilans', with extensive deformities, particularly of the distal phalanges of the hands. The clinical, radiological and pathological aspects of the disorder are discussed and a review of the literature is included. The differential diagnosis, particularly including rheumatoid arthritis, is described in detail. The pathogenesis of the disorder is considered. (orig./SHA)

A prospective observational study of ICU patient position and frequency of turning.

Science.gov (United States)

Goldhill, D R; Badacsonyi, A; Goldhill, A A; Waldmann, C

2008-05-01

Positioning and turning critically ill patients may be beneficial but there are little data on current practice. We prospectively recorded patient position every hour over two separate days in 40 British intensive care units and analysed 393 sets of observation. Five patients were prone at any time and 3.8% (day 1) and 5% (day 2) were on rotating beds. Patients were on their back for 46.1% of observations, turned left for 28.4% and right for 25.5%, and head up for 97.4%. A turn was defined as a change between on back, turned left or turned right. The average time (SD) between turns was 4.85 (3.3) h. There was no significant association between the average time between turns and age, weight, height, gender, respiratory diagnosis, intubated and ventilated, sedation score, day of week or nurse:patient ratio. There was a significant difference between hospitals in the frequency with which patients were turned.

[Therapeutic characteristance and tolerance of topical comfrey preparations. Results of an observational study of patients].

Science.gov (United States)

Koll, R; Klingenburg, S

2002-01-01

To analyze the anti-inflammatory and analgetic properties of the topical comfrey, preparations Kytta-Salbe f, Kytta-Plasma f and Kytta-Balsam f applied to bruises, sprains and distortions and painful conditions of the muscles and joints. A prospective open multicentric observational study complying with paragraph 67(6) of the AMG and involving 162 general practitioners. During the two-week period of observation, the patients received an average of one to three applications of the comfrey preparation per day. All 492 questionnaires were evaluated. Efficacy and tolerability were assessed by both physician and patient. Pain at rest and on movement, as also tenderness, improved in the overall observation group by an average of 45-47%. The duration of morning joint stiffness decreased from 20 minutes initially to 3 minutes. During the course of treatment with comfrey, more than two-thirds of the patients were able to reduce or even discontinue their intake of non-steroidal anti-inflammatory drugs and other specific concomitant medication. In most of the cases, both effectiveness and tolerability were assessed to be excellent or good. The results of the study confirm the effectiveness and tolerability of the topical comfrey preparation investigated in the treatment of bruises, sprains and distortions as well as painful conditions affecting muscles and joints.

Multicentre European study of thalamic stimulation in parkinsonian and essential tremor

NARCIS (Netherlands)

Limousin, P.; Speelman, J. D.; Gielen, F.; Janssens, M.

1999-01-01

Thalamic stimulation has been proposed to treat disabling tremor. The aims of this multicentre study were to evaluate the efficacy and the morbidity of thalamic stimulation in a large number of patients with parkinsonian or essential tremor. One hundred and eleven patients were included in the study

Comparison of manual and semi-automatic measuring techniques in MSCT scans of patients with lymphoma: a multicentre study

Energy Technology Data Exchange (ETDEWEB)

Hoeink, A.J.; Wessling, J.; Schuelke, C.; Kohlhase, N.; Wassenaar, L.; Heindel, W.; Buerke, B. [University Hospital Muenster, Department of Clinical Radiology, Muenster (Germany); Koch, R. [University of Muenster, Institute of Biostatistics and Clinical Research (IBKF), Muenster (Germany); Mesters, R.M. [University Hospital Muenster, Department of Haematology and Oncology, Muenster (Germany); D' Anastasi, M.; Graser, A.; Karpitschka, M. [University Hospital Muenchen (LMU), Institute of Clinical Radiology, Muenchen (Germany); Fabel, M.; Wulff, A. [University Hospital Kiel, Department of Clinical Radiology, Kiel (Germany); Pinto dos Santos, D. [University Hospital Mainz, Department of Diagnostic and Interventional Radiology, Mainz (Germany); Kiessling, A. [University Hospital Marburg, Department of Diagnostic and Interventional Radiology, Marburg (Germany); Dicken, V.; Bornemann, L. [Institute of Medical Imaging Computing, Fraunhofer MeVis, Bremen (Germany)

2014-11-15

Multicentre evaluation of the precision of semi-automatic 2D/3D measurements in comparison to manual, linear measurements of lymph nodes regarding their inter-observer variability in multi-slice CT (MSCT) of patients with lymphoma. MSCT data of 63 patients were interpreted before and after chemotherapy by one/tworadiologists in five university hospitals. In 307 lymph nodes, short (SAD)/long (LAD) axis diameter and WHO area were determined manually and semi-automatically. Volume was solely calculated semi-automatically. To determine the precision of the individual parameters, a mean was calculated for every lymph node/parameter. Deviation of the measured parameters from this mean was evaluated separately. Statistical analysis entailed intraclass correlation coefficients (ICC) and Kruskal-Wallis tests. Median relative deviations of semi-automatic parameters were smaller than deviations of manually assessed parameters, e.g. semi-automatic SAD 5.3 vs. manual 6.5 %. Median variations among different study sites were smaller if the measurement was conducted semi-automatically, e. g. manual LAD 5.7/4.2 % vs. semi-automatic 3.4/3.4 %. Semi-automatic volumetry was superior to the other parameters (2.8 %). Semi-automatic determination of different lymph node parameters is (compared to manually assessed parameters) associated with a slightly greater precision and a marginally lower inter-observer variability. These results are with regard to the increasing mobility of patients among different medical centres and in relation to the quality management of multicentre trials of importance. (orig.)

Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: A study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856

Directory of Open Access Journals (Sweden)

Krämer Jürgen

2004-03-01

Full Text Available Abstract Background Controlled clinical trials produced contradictory results with respect to a specific analgesic effect of acupuncture. There is a lack of large multi-centre acupuncture trials. The German Acupuncture Trial represents the largest multi-centre study of acupuncture in the treatment of chronic pain caused by gonarthrosis up to now. Methods 900 patients will be randomised to three treatment arms. One group receives verum acupuncture, the second sham acupuncture, and the third conservative standard therapy. The trial protocol is described with eligibility criteria, detailed information on the treatment definition, blinding, endpoints, safety evaluation, statistical methods, sample size determination, monitoring, legal aspects, and the current status of the trial. Discussion A critical discussion is given regarding the considerations about standardisation of the acupuncture treatment, the choice of the control group, and the blinding of patients and observers.

Diversity of Clostridium difficile PCR ribotypes in Europe: results from the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID), 2012 and 2013.

Science.gov (United States)

Davies, Kerrie A; Ashwin, Helen; Longshaw, Christopher M; Burns, David A; Davis, Georgina L; Wilcox, Mark H

2016-07-21

Clostridium difficile infection (CDI) is the major cause of infective diarrhoea in healthcare environments. As part of the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID), the largest C. difficile epidemiological study of its type, PCR ribotype distribution of C. difficile isolates in Europe was investigated. PCR ribotyping was performed on 1,196 C. difficile isolates from diarrhoeal samples sent to the European coordinating laboratory in 2012-13 and 2013 (from two sampling days) by 482 participating hospitals from 19 European countries. A total of 125 ribotypes were identified, of which ribotypes 027 (19%, n =222), 001/072 (11%, n = 134) and 014/020 (10%, n = 119) were the most prevalent. Distinct regional patterns of ribotype distribution were noted. Of 596 isolates from patients with toxin-positive stools (CDI cases), ribotype 027 accounted for 22% (32/144) of infections in cases aged from 18 to less than 65 years, but the prevalence decreased in those aged ≥ 65 years (14% (59/412)) and further decreased in those aged ≥ 81 years (9% (18/195)). The prevalence of ribotype 027 and 176, but not other epidemic strains, was inversely proportional to overall ribotype diversity (R(2) = 0.717). This study highlights an increased diversity of C. difficile ribotypes across Europe compared with previous studies, with considerable intercountry variation in ribotype distribution. Continuous surveillance programmes are necessary to monitor the changing epidemiology of C. difficile. This article is copyright of The Authors, 2016.

Multicentre quality assurance of intensity-modulated radiation therapy plans: a precursor to clinical trials

International Nuclear Information System (INIS)

Williams, M. J.; Bailey, M. J.; Forstner, D.; Metcalfe, P. E

2007-01-01

Full text: A multicentre planning study comparing intensity-modulated radiation therapy (IMRT) plans for the treatment of a head and neck cancer has been carried out. Three Australian radiotherapy centres, each with a different planning system, were supplied a fully contoured CT dataset and requested to generate an IMRT plan in accordance with the requirements of an IMRT-based radiation therapy oncology group clinical trial. Plan analysis was carried out using software developed specifically for reviewing multicentre clinical trial data. Two out of the three plans failed to meet the prescription requirements with one misinterpreting the prescription and the third failed to meet one of the constraints. Only one plan achieved all of the dose objectives for the critical structures and normal tissues. Although each centre used very similar planning parameters and beam arrangements the resulting plans were quite different. The subjective interpretation and application of the prescription and planning objectives emphasize one of the many difficulties in carrying out multicentre IMRT planning studies. The treatment prescription protocol in a clinical trial must be both lucid and unequivocally stated to avoid misinterpretation. Australian radiotherapy centres must show that they can produce a quality IMRT plan and that they can adhere to protocols for IMRT planning before using it in a clinical trial

[Establishment and Management of Multicentral Collection Bio-sample Banks of Malignant Tumors from Digestive System].

Science.gov (United States)

Shen, Si; Shen, Junwei; Zhu, Liang; Wu, Chaoqun; Li, Dongliang; Yu, Hongyu; Qiu, Yuanyuan; Zhou, Yi

2015-11-01

To establish and manage of multicentral collection bio-sample banks of malignant tumors from digestive system, the paper designed a multicentral management system, established the standard operation procedures (SOPs) and leaded ten hospitals nationwide to collect tumor samples. The biobank has been established for half a year, and has collected 695 samples from patients with digestive system malignant tumor. The clinical data is full and complete, labeled in a unified way and classified to be managed. The clinical and molecular biology researches were based on the biobank, and obtained achievements. The biobank provides a research platform for malignant tumor of digestive system from different regions and of different types.

Proposal for the standardisation of multi-centre trials in nuclear medicine imaging

DEFF Research Database (Denmark)

Dickson, John Caddell; Tossici-Bolt, Livia; Sera, Terez

2012-01-01

Multi-centre trials are an important part of proving the efficacy of procedures, drugs and interventions. Imaging components in such trials are becoming increasingly common; however, without sufficient control measures the usefulness of these data can be compromised. This paper describes a framew...

Violent women : A multicentre study into gender differences in forensic psychiatric patients

NARCIS (Netherlands)

de Vogel, Vivienne; Stam, Jeantine; Bouman, Yvonne H. A.; Ter Horst, P.R.M.; Lancel, Marike

2016-01-01

To gain insight into the relatively small, but increasing group of women in forensic psychiatry, a retrospective multicentre study was started gathering information from the files of 275 female patients of four Dutch forensic psychiatric hospitals on characteristics and violence risk factors.

Pregnancy-specific stress, fetoplacental haemodynamics, and neonatal outcomes in women with small for gestational age pregnancies: a secondary analysis of the multicentre Prospective Observational Trial to Optimise Paediatric Health in Intrauterine Growth Restriction.

Science.gov (United States)

Levine, Terri A; Grunau, Ruth E; Segurado, Ricardo; Daly, Sean; Geary, Michael P; Kennelly, Mairead M; O'Donoghue, Keelin; Hunter, Alyson; Morrison, John J; Burke, Gerard; Dicker, Patrick; Tully, Elizabeth C; Malone, Fergal D; Alderdice, Fiona A; McAuliffe, Fionnuala M

2017-06-21

To examine associations between maternal pregnancy-specific stress and umbilical (UA PI) and middle cerebral artery pulsatility indices (MCA PI), cerebroplacental ratio, absent end diastolic flow (AEDF), birthweight, prematurity, neonatal intensive care unit admission and adverse obstetric outcomes in women with small for gestational age pregnancies. It was hypothesised that maternal pregnancy-specific stress would be associated with fetoplacental haemodynamics and neonatal outcomes. This is a secondary analysis of data collected for a large-scale prospective observational study. This study was conducted in the seven major obstetric hospitals in Ireland and Northern Ireland. Participants included 331 women who participated in the Prospective Observational Trial to Optimise Paediatric Health in Intrauterine Growth Restriction. Women with singleton pregnancies between 24 and 36 weeks gestation, estimated fetal weight <10th percentile and no major structural or chromosomal abnormalities were included. Serial Doppler ultrasound examinations of the umbilical and middle cerebral arteries between 20 and 42 weeks gestation, Pregnancy Distress Questionnaire (PDQ) scores between 23 and 40 weeks gestation and neonatal outcomes. Concerns about physical symptoms and body image at 35-40 weeks were associated with lower odds of abnormal UAPI (OR 0.826, 95% CI 0.696 to 0.979, p=0.028). PDQ score (OR 1.073, 95% CI 1.012 to 1.137, p=0.017), concerns about birth and the baby (OR 1.143, 95% CI 1.037 to 1.260, p=0.007) and concerns about physical symptoms and body image (OR 1.283, 95% CI 1.070 to 1.538, p=0.007) at 29-34 weeks were associated with higher odds of abnormal MCA PI. Concerns about birth and the baby at 29-34 weeks (OR 1.202, 95% CI 1.018 to 1.421, p=0.030) were associated with higher odds of AEDF. Concerns about physical symptoms and body image at 35-40 weeks were associated with decreased odds of neonatal intensive care unit admission (OR 0.635, 95% CI 0

A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration

NARCIS (Netherlands)

Asten, F. van; Evers-Birkenkamp, K.U.; Lith-Verhoeven, J.J. van; Jong-Hesse, Y. de; Hoppenreijs, V.P.T.; Hommersom, R.F.; Scholten, A.M.; Hoyng, C.B.; Klaver, J.H.

2015-01-01

PURPOSE: The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice.

Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

Directory of Open Access Journals (Sweden)

Dijkgraaf Marcel G

2010-03-01

Full Text Available Abstract Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303

Perinatal complications in patients with unisutural craniosynostosis: An international multicentre retrospective cohort study

NARCIS (Netherlands)

Cornelissen, Martijn J.; Softeland, Madiha; Apon, Inge; Ladfors, Lars; Mathijssen, Irene M. J.; Cohen-Overbeek, Titia E.; Bonsel, Gouke J.; Kolby, Lars

2017-01-01

Purpose Craniosynostosis may lead to hampered fetal head molding and birth complications. To study the interaction between single suture craniosynostosis and delivery complications, an international, multicentre, retrospective cohort study was performed. Materials and methods All infants born

Detection of residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (preSANO): a prospective multicentre, diagnostic cohort study.

Science.gov (United States)

Noordman, Bo Jan; Spaander, Manon C W; Valkema, Roelf; Wijnhoven, Bas P L; van Berge Henegouwen, Mark I; Shapiro, Joël; Biermann, Katharina; van der Gaast, Ate; van Hillegersberg, Richard; Hulshof, Maarten C C M; Krishnadath, Kausilia K; Lagarde, Sjoerd M; Nieuwenhuijzen, Grard A P; Oostenbrug, Liekele E; Siersema, Peter D; Schoon, Erik J; Sosef, Meindert N; Steyerberg, Ewout W; van Lanschot, J Jan B

2018-05-31

After neoadjuvant chemoradiotherapy for oesophageal cancer, roughly half of the patients with squamous cell carcinoma and a quarter of those with adenocarcinoma have a pathological complete response of the primary tumour before surgery. Thus, the necessity of standard oesophagectomy after neoadjuvant chemoradiotherapy should be reconsidered for patients who respond sufficiently to neoadjuvant treatment. In this study, we aimed to establish the accuracy of detection of residual disease after neoadjuvant chemoradiotherapy with different diagnostic approaches, and the optimal combination of diagnostic techniques for clinical response evaluations. The preSANO trial was a prospective, multicentre, diagnostic cohort study at six centres in the Netherlands. Eligible patients were aged 18 years or older, had histologically proven, resectable, squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophagogastric junction, and were eligible for potential curative therapy with neoadjuvant chemoradiotherapy (five weekly cycles of carboplatin [area under the curve 2 mg/mL per min] plus paclitaxel [50 mg/m 2 of body-surface area] combined with 41·4 Gy radiotherapy in 23 fractions) followed by oesophagectomy. 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients had oesophagogastroduodenoscopy with biopsies and endoscopic ultrasonography with measurement of maximum tumour thickness. Patients with histologically proven locoregional residual disease or no-pass during endoscopy and without distant metastases underwent immediate surgical resection. In the remaining patients a second clinical response evaluation was done (PET-CT, oesophagogastroduodenoscopy with biopsies, endoscopic ultrasonography with measurement of maximum tumour thickness, and fine-needle aspiration of suspicious lymph nodes), followed by surgery 12-14 weeks after completion of neoadjuvant chemoradiotherapy. The primary endpoint was the correlation between clinical response during

Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study.

Science.gov (United States)

Dorman, Susan E; Schumacher, Samuel G; Alland, David; Nabeta, Pamela; Armstrong, Derek T; King, Bonnie; Hall, Sandra L; Chakravorty, Soumitesh; Cirillo, Daniela M; Tukvadze, Nestani; Bablishvili, Nino; Stevens, Wendy; Scott, Lesley; Rodrigues, Camilla; Kazi, Mubin I; Joloba, Moses; Nakiyingi, Lydia; Nicol, Mark P; Ghebrekristos, Yonas; Anyango, Irene; Murithi, Wilfred; Dietze, Reynaldo; Lyrio Peres, Renata; Skrahina, Alena; Auchynka, Vera; Chopra, Kamal Kishore; Hanif, Mahmud; Liu, Xin; Yuan, Xing; Boehme, Catharina C; Ellner, Jerrold J; Denkinger, Claudia M

2018-01-01

The Xpert MTB/RIF assay is an automated molecular test that has improved the detection of tuberculosis and rifampicin resistance, but its sensitivity is inadequate in patients with paucibacillary disease or HIV. Xpert MTB/RIF Ultra (Xpert Ultra) was developed to overcome this limitation. We compared the diagnostic performance of Xpert Ultra with that of Xpert for detection of tuberculosis and rifampicin resistance. In this prospective, multicentre, diagnostic accuracy study, we recruited adults with pulmonary tuberculosis symptoms presenting at primary health-care centres and hospitals in eight countries (South Africa, Uganda, Kenya, India, China, Georgia, Belarus, and Brazil). Participants were allocated to the case detection group if no drugs had been taken for tuberculosis in the past 6 months or to the multidrug-resistance risk group if drugs for tuberculosis had been taken in the past 6 months, but drug resistance was suspected. Demographic information, medical history, chest imaging results, and HIV test results were recorded at enrolment, and each participant gave at least three sputum specimen on 2 separate days. Xpert and Xpert Ultra diagnostic performance in the same sputum specimen was compared with culture tests and drug susceptibility testing as reference standards. The primary objectives were to estimate and compare the sensitivity of Xpert Ultra test with that of Xpert for detection of smear-negative tuberculosis and rifampicin resistance and to estimate and compare Xpert Ultra and Xpert specificities for detection of rifampicin resistance. Study participants in the case detection group were included in all analyses, whereas participants in the multidrug-resistance risk group were only included in analyses of rifampicin-resistance detection. Between Feb 18, and Dec 24, 2016, we enrolled 2368 participants for sputum sampling. 248 participants were excluded from the analysis, and 1753 participants were distributed to the case detection group (n=1439

A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration

NARCIS (Netherlands)

van Asten, Freekje; Evers-Birkenkamp, Kim U.; van Lith-Verhoeven, Janneke J. C.; de Jong-Hesse, Yvonne; Hoppenreijs, Vincent P. T.; Hommersom, Richard F.; Scholten, Agnes M.; Hoyng, Carel B.; Klaver, Johannes H. J.; Klaver, J. H. J.; Hoyng, C. B.; Raijmakers, A. J.; van Lith-Verhoeven, J. J. C.; Rulo, A. H. F.; Verbraak, F. D.; Schlingemann, R. O.; Hommersom, C. F.; de Jong-Hesse, Y.; Bosch-Driessen, E. H.; Smeets, M. H.; Gonçalves, A.; Klomp, H. J.; Hoppenreijs, V. P. T.; Dito, J. J.

2015-01-01

The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. The HELIOS

Effect of the TNF-α inhibitor adalimumab in patients with recalcitrant sarcoidosis: a prospective observational study using FDG-PET

DEFF Research Database (Denmark)

Milman, Nils; Graudal, Niels; Loft, Annika

2012-01-01

-PET) in patients with recalcitrant sarcoidosis treated with adalimumab. Methods: Prospective 24-week observational study. Patients continued medication with steroids and antimetabolites and received adalimumab 40 mg subcutaneously every other week. Ten patients with biopsy-proven sarcoidosis (two men) were...

The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis

NARCIS (Netherlands)

Abbott, T. E. F.; Ahmad, T.; Phull, M. K.; Fowler, A. J.; Hewson, R.; Biccard, B. M.; Chew, M. S.; Gillies, M.; Pearse, R. M.; Pearse, Rupert M.; Beattie, Scott; Clavien, Pierre-Alain; Demartines, Nicolas; Fleisher, Lee A.; Grocott, Mike; Haddow, James; Hoeft, Andreas; Holt, Peter; Moreno, Rui; Pritchard, Naomi; Rhodes, Andrew; Wijeysundera, Duminda; Wilson, Matt; Ahmed, Tahania; Everingham, Kirsty; Hewson, Russell; Januszewska, Marta; Phull, Mandeep-Kaur; Halliwell, Richard; Shulman, Mark; Myles, Paul; Schmid, Werner; Hiesmayr, Michael; Wouters, Patrick; de Hert, Stefan; Lobo, Suzana; Fang, Xiangming; Rasmussen, Lars; Futier, Emmanuel; Biais, Matthieu; Venara, Aurélien; Slim, Karem; Sander, Michael; Koulenti, Despoina; Arvaniti, Kostoula; Chan, Mathew; Kulkarni, Atul; Chandra, Susilo; Tantri, Aida; Geddoa, Emad; Abbas, Muntadhar; Della Rocca, Giorgio; Sivasakthi, Datin; Mansor, Marzida; Luna, Pastor; Bouwman, Arthur; Buhre, Wolfgang; Beavis, Vanessa; Campbell, Douglas; Short, Tim; Osinaike, Tunde; Matos, Ricardo; Grigoras, Ioana; Kirov, Mikhail; Protsenko, Denis; Biccard, Bruce; Aldecoa, Cesar; Chew, Michelle; Hofer, Christoph; Hubner, Martin; Ditai, James; Szakmany, Tamas; Fleisher, Lee; Ferguson, Marissa; MacMahon, Michael; Cherian, Ritchie; Currow, Helen; Kanathiban, Kathirgamanathan; Gillespie, David; Pathmanathan, Edward; Phillips, Katherine; Reynolds, Jenifer; Rowley, Joanne; Douglas, Jeanene; Kerridge, Ross; Garg, Sameer; Bennett, Michael; Jain, Megha; Alcock, David; Terblanche, Nico; Cotter, Rochelle; Leslie, Kate; Stewart, Marcelle; Zingerle, Nicolette; Clyde, Antony; Hambidge, Oliver; Rehak, Adam; Cotterell, Sharon; Huynh, Wilson Binh Quan; McCulloch, Timothy; Ben-Menachem, Erez; Egan, Thomas; Cope, Jennifer; Fellinger, Paul; Haisjackl, Markus; Haselberger, Simone; Holaubek, Caroline; Lichtenegger, Paul; Scherz, Florian; Hoffer, Franz; Cakova, Veronika; Eichwalder, Andreas; Fischbach, Norbert; Klug, Reinhold; Schneider, Elisabeth; Vesely, Martin; Wickenhauser, Reinhart; Grubmueller, Karl Gernot; Leitgeb, Marion; Lang, Friedrich; Toro, Nancy; Bauer, Marlene; Laengle, Friedrich; Haberl, Claudia; Mayrhofer, Thomas; Trybus, Christoph; Buerkle, Christian; Forstner, Karin; Germann, Reinhard; Rinoesl, Harald; Schindler, Elke; Trampitsch, Ernst; Bogner, Gerhard; Dankl, Daniel; Duenser, Martin; Fritsch, Gerhard; Gradwohl-Matis, Ilse; Hartmann, Andreas; Hoelzenbein, Thomas; Jaeger, Tarkan; Landauer, Franz; Lindl, Gregor; Lux, Michael; Steindl, Johannes; Stundner, Ottokar; Szabo, Christian; Bidgoli, Jawad; Verdoodt, Hans; Forget, Patrice; Kahn, David; Lois, Fernande; Momeni, Mona; Prégardien, Caroline; Pospiech, Audrey; Steyaert, Arnaud; Veevaete, Laurent; de Kegel, Dirk; de Jongh, Karen; Foubert, Luc; Smitz, Carine; Vercauteren, Marcel; Poelaert, Jan; van Mossevelde, Veerle; Abeloos, Jacques; Bouchez, Stefaan; Coppens, Marc; de Baerdemaeker, Luc; Deblaere, Isabel; de Bruyne, Ann; Fonck, Kristine; Heyse, Bjorn; Jacobs, Tom; Lapage, Koen; Moerman, Anneliese; Neckebroek, Martine; Parashchanka, Aliaksandra; Roels, Nathalie; van den Eynde, Nancy; Vandenheuvel, Michael; Limmen, JurgenVan; Vanluchene, Ann; Vanpeteghem, Caroline; Wyffels, Piet; Huygens, Christel; Vandenbempt, Punitha; van de Velde, Marc; Dylst, Dimitri; Janssen, Bruno; Schreurs, Evelien; Aleixo, Fábia Berganton; Candido, Keulle; Batista, Hugo Dias; Guimarães, Mario; Guizeline, Jaqueline; Hoffmann, João; Lobo, Francisco Ricardo Marques; Nascimento, Vinícius; Nishiyama, Katia; Pazetto, Lucas; Souza, Daniela; Rodrigues, Rodrigo Souza; Vilela Dos Santos, Ana Maria; Jardim, Jaquelline; Sá Malbouisson, Luiz Marcelo; Silva, Joao; Nascimento Junior, Paulo do; Baio, Thalissa Hermínia; Pereira de Castro, Gabriel Isaac; Watanabe Oliveira, Henri Roger; Amendola, Cristina Prata; Cardoso, Gutemberg; Ortega, Daniela; Brotto, Ana Flavia; de Oliveira, Mirella Cristine; Réa-Neto, Álvaro; Dias, Fernando; Travi, Maria Eduarda; Zerman, Luiza; Azambuja, Pedro; Knibel, Marcos Freitas; Martins, Antonio; Almeida, William; Neto, Calim Neder; Tardelli, Maria Angela; Caser, Eliana; Machado, Marcio; Aguzzoli, Crisitiano; Baldisserotto, Sérgio; Tabajara, Fernanda Beck; Bettega, Fernanda; Rodrigues Júnior, La Hore Correa; de Gasperi, Julia; Faina, Lais; Nolasco, Marcos Farias; Ferreira da Costa Fischer, Bruna; Fosch de Campos Ferreira, Mariana; Hartmann, Cristina; Kliemann, Marta; Hubert Ribeiro, Gustavo Luis; Fraga, Julia Merladete; Netto, Thiago Motta; Pozza, Laura Valduga; Wendling, Paulo Rafael; Azevedo, Caroline; Garcia, Juliana; Lopes, Marcel; Maia, Bernardo; Maselli, Paula; Melo, Ralph; Mendes, Weslley; Neves, Matheus; Ney, Jacqueline; Piras, Claudio; Applewhaite, Christopher; Carr, Adrienne; Chow, Lorraine; Duttchen, Kaylene; Foglia, Julena; Greene, Michael; Hinther, Ashley; Houston, Kendra; McCormick, Thomas Jared; Mikhayel, Jennifer; Montasser, Sam; Ragan, Alex; Suen, Andrew; Woolsey, Adrianna; Yu, Hai Chuan; Funk, Duane; Kowalski, Stephen; Legaspi, Regina; McDonald, Heather; Siddiqui, Faisal; Pridham, Jeremy; Rowe, Bernadette; Sampson, Sonia; Thiessen, Barton; Zbitnew, Geoff; Bernard, Andre; George, Ronald; Jones, Philip; Moor, Rita; Siddiqui, Naveed; Wolfer, Alexandra; Tran, Diem; Winch, Denyse; Dobson, Gary; McCormick, Thomas; Montasser, Osama; Hall, Richard; Baghirzada, Leyla; Curley, Gerard; Dai, Si Yuan; Hare, Gregory; Lee, Esther; Shastri, Uma; Tsui, Albert; Yagnik, Anmol; Alvares, Danielle; Choi, Stephen; Dwyer, Heather; Flores, Kathrina; McCartney, Colin; Somascanthan, Priya; Carroll, Jo; Pazmino-Canizares, Janneth; Ami, Noam; Chan, Vincent; Perlas, Anahi; Argue, Ruth; Huang, Yang; Lavis, Katie; Mayson, Kelly; Cao, Ying; Gao, Hong; Hu, Tingju; Lv, Jie; Yang, Jian; Yang, Yang; Zhong, Yi; Zhou, Jing; Zou, Xiaohua; He, Miao; Li, Xiaoying; Luo, Dihuan; Wang, Haiying; Yu, Tian; Chen, Liyong; Wang, Lijun; Cai, Yunfei; Cao, Zhongming; Li, Yanling; Lian, Jiaxin; Sun, Haiyun; Wang, Sheng; Wang, Zhipeng; Wang, Kenru; Zhu, Yi; Du, Xindan; Fan, Hao; Fu, Yunbin; Huang, Lixia; Huang, Yanming; Hwan, Haifang; Luo, Hong; Qu, Pi-Sheng; Tao, Fan; Wang, Zhen; Wang, Guoxiang; Wang, Shun; Zhang, Yan; Zhang, Xiaolin; Chen, Chao; Wang, Weixing; Liu, Zhengyuan; Fan, Lihua; Tang, Jing; Chen, Yijun; Chen, Yongjie; Han, Yangyang; Huang, Changshun; Liang, Guojin; Shen, Jing; Wang, Jun; Yang, Qiuhong; Zhen, Jungang; Zhou, Haidong; Chen, Junping; Chen, Zhang; Li, Xiaoyu; Meng, Bo; Ye, Haiwang; Zhang, Xiaoyan; Bi, Yanbing; Cao, Jianqiao; Guo, Fengying; Lin, Hong; Liu, Yang; Lv, Meng; Shi, Pengcai; Song, Xiumei; Sun, Chuanyu; Sun, Yongtao; Wang, Yuelan; Wang, Shenhui; Zhang, Min; Chen, Rong; Hou, Jiabao; Leng, Yan; Meng, Qing-Tao; Qian, Li; Shen, Zi-Ying; Xia, Zhong-Yuan; Xue, Rui; Zhang, Yuan; Zhao, Bo; Zhou, Xian-Jin; Chen, Qiang; Guo, Huinan; Guo, Yongqing; Qi, Yuehong; Wang, Zhi; Wei, Jianfeng; Zhang, Weiwei; Zheng, Lina; Bao, Qi; Chen, Yaqiu; Chen, Yijiao; Fei, Yue; Hu, Nianqiang; Hu, Xuming; Lei, Min; Li, Xiaoqin; Lv, Xiaocui; Miao, Fangfang; Ouyang, Lingling; Qian, Lu; Shen, Conyu; Sun, Yu; Wang, Yuting; Wang, Dong; Wu, Chao; Xu, Liyuan; Yuan, Jiaqi; Zhang, Lina; Zhang, Huan; Zhang, Yapping; Zhao, Jinning; Zhao, Chong; Zhao, Lei; Zheng, Tianzhao; Zhou, Dachun; Zhou, Haiyan; Zhou, Ce; Lu, Kaizhi; Zhao, Ting; He, Changlin; Chen, Hong; Chen, Shasha; Cheng, Baoli; He, Jie; Jin, Lin; Li, Caixia; Li, Hui; Pan, Yuanming; Shi, Yugang; Wen, Xiao Hong; Wu, Shuijing; Xie, Guohao; Zhang, Kai; Zhao, Bing; Lu, Xianfu; Chen, Feifei; Liang, Qisheng; Lin, Xuewu; Ling, Yunzhi; Liu, Gang; Tao, Jing; Yang, Lu; Zhou, Jialong; Chen, Fumei; Cheng, Zhonggui; Dai, Hanying; Feng, Yunlin; Hou, Benchao; Gong, Haixia; Hu, Chun Hua; Huang, Haijin; Huang, Jian; Jiang, Zhangjie; Li, Mengyuan; Lin, Jiamei; Liu, Mei; Liu, Weicheng; Liu, Zhen; Liu, Zhiyi; Luo, Foquan; Ma, Longxian; Min, Jia; Shi, Xiaoyun; Song, Zhiping; Wan, Xianwen; Xiong, Yingfen; Xu, Lin; Yang, Shuangjia; Zhang, Qin; Zhang, Hongyan; Zhang, Huaigen; Zhang, Xuekang; Zhao, Lili; Zhao, Weihong; Zhao, Weilu; Zhu, Xiaoping; Bai, Yun; Chen, Linbi; Chen, Sijia; Dai, Qinxue; Geng, Wujun; Han, Kunyuan; He, Xin; Huang, Luping; Ji, Binbin; Jia, Danyun; Jin, Shenhui; Li, Qianjun; Liang, Dongdong; Luo, Shan; Lwang, Lulu; Mo, Yunchang; Pan, Yuanyuan; Qi, Xinyu; Qian, Meizi; Qin, Jinling; Ren, Yelong; Shi, Yiyi; Wang, Junlu; Wang, Junkai; Wang, Leilei; Xie, Junjie; Yan, Yixiu; Yao, Yurui; Zhang, Mingxiao; Zhao, Jiashi; Zhuang, Xiuxiu; Ai, Yanqiu; Du, Fang; He, Long; Huang, Ledan; Li, Zhisong; Li, Huijuan; Li, Yetong; Li, Liwei; Meng, Su; Yuan, Yazhuo; Zhang, Enman; Zhang, Jie; Zhao, Shuna; Ji, Zhenrong; Pei, Ling; Wang, Li; Chen, Chen; Dong, Beibei; Li, Jing; Miao, Ziqiang; Mu, Hongying; Qin, Chao; Su, Lin; Wen, Zhiting; Xie, Keliang; Yu, Yonghao; Yuan, Fang; Hu, Xianwen; Zhang, Ye; Xiao, Wangpin; Zhu, Zhipeng; Dai, Qingqing; Fu, Kaiwen; Hu, Rong; Hu, Xiaolan; Huang, Song; Li, Yaqi; Liang, Yingping; Yu, Shuchun; Guo, Zheng; Jing, Yan; Tang, Na; Wu, Jie; Yuan, Dajiang; Zhang, Ruilin; Zhao, Xiaoying; Li, Yuhong; Bai, Hui-Ping; Liu, Chun-Xiao; Liu, Fei-Fei; Ren, Wei; Wang, Xiu-Li; Xu, Guan-Jie; Hu, Na; Li, Bo; Ou, Yangwen; Tang, Yongzhong; Yao, Shanglong; Zhang, Shihai; Kong, Cui-Cui; Liu, Bei; Wang, Tianlong; Xiao, Wei; Lu, Bo; Xia, Yanfei; Zhou, Jiali; Cai, Fang; Chen, Pushan; Hu, Shuangfei; Wang, Hongfa; Xu, Qiong; Hu, Liu; Jing, Liang; Li, Bin; Liu, Qiang; Liu, Yuejiang; Lu, Xinjian; Peng, Zhen Dan; Qiu, Xiaodong; Ren, Quan; Tong, Youliang; Wang, Jin; Wen, Yazhou; Wu, Qiong; Xia, Jiangyan; Xie, Jue; Xiong, Xiapei; Xu, Shixia; Yang, Tianqin; Ye, Hui; Yin, Ning; Yuan, Jing; Zeng, Qiuting; Zhang, Baoling; Zheng, Kang; Cang, Jing; Chen, Shiyu; Fan, Yu; Fu, Shuying; Ge, Xiaodong; Guo, Baolei; Huang, Wenhui; Jiang, Linghui; Jiang, Xinmei; Liu, Yi; Pan, Yan; Ren, Yun; Shan, Qi; Wang, Jiaxing; Wang, Fei; Wu, Chi; Zhang, Xiaoguang; Christiansen, Ida Cecilie; Granum, Simon Nørgaard; Rasmussen, Bodil Steen; Daugaard, Morten; Gambhir, Rajiv; Brandsborg, Birgitte; Steingrímsdóttir, Guðný Erla; Jensen-Gadegaard, Peter; Olsen, Karsten Skovgaard; Siegel, Hanna; Eskildsen, Katrine Zwicky; Gätke, Mona Ring; Wibrandt, Ida; Heintzelmann, Simon Bisgaard; Wiborg Lange, Kai Henrik; Lundsgaard, Rune Sarauw; Amstrup-Hansen, Louise; Hovendal, Claus; Larsen, Michael; Lenstrup, Mette; Kobborg, Tina; Larsen, Jens Rolighed; Pedersen, Anette Barbre; Smith, Søren Hübertz; Oestervig, Rebecca Monett; Afshari, Arash; Andersen, Cheme; Ekelund, Kim; Secher, Erik Lilja; Beloeil, Helene; Lasocki, Sigismond; Ouattara, Alexandre; Sineus, Marlene; Molliex, Serge; Legouge, Marie Lim; Wallet, Florent; Tesniere, Antoine; Gaudin, Christophe; Lehur, Paul; Forsans, Emma; de Rudnicki, Stéphane; Maudet, Valerie Serra; Mutter, Didier; Sojod, Ghassan; Ouaissi, Mehdi; Regimbeau, Jean-Marc; Desbordes, Jacques; Comptaer, Nicolas; Manser, Diae El; Ethgen, Sabine; Lebuffe, Gilles; Auer, Patrick; Härtl, Christine; Deja, Maria; Legashov, Kirill; Sonnemann, Susanne; Wiegand-Loehnert, Carola; Falk, Elke; Habicher, Marit; Angermair, Stefan; Laetsch, Beatrix; Schmidt, Katrin; von Heymann, Christian; Ramminger, Axel; Jelschen, Florian; Pabel, Svenja; Weyland, Andreas; Czeslick, Elke; Gille, Jochen; Malcharek, Michael; Sablotzki, Armin; Lueke, Katharina; Wetzel, Peter; Weimann, Joerg; Lenhart, Franz-Peter; Reichle, Florian; Schirmer, Frederike; Hüppe, Michael; Klotz, Karl; Nau, Carla; Schön, Julika; Mencke, Thomas; Wasmund, Christina; Bankewitz, Carla; Baumgarten, Georg; Fleischer, Andreas; Guttenthaler, Vera; Hack, Yvonne; Kirchgaessner, Katharina; Männer, Olja; Schurig-Urbaniak, Marlen; Struck, Rafael; van Zyl, Rebekka; Wittmann, Maria; Goebel, Ulrich; Harris, Sarah; Veit, Siegfried; Andreadaki, Evangelia; Souri, Flora; Katsiadramis, Ioannis; Skoufi, Anthi; Vasileiou, Maria; Aimoniotou-Georgiou, Eleni; Katsourakis, Anastasios; Veroniki, Fotini; Vlachogianni, Glyceria; Petra, Konstantina; Chlorou, Dimitra; Oloktsidou, Eirini; Ourailoglou, Vasileios; Papapostolou, Konstantinos; Tsaousi, Georgia; Daikou, Panagoula; Dedemadi, Georgia; Kalaitzopoulos, Ioannis; Loumpias, Christos; Bristogiannis, Sotirios; Dafnios, Nikolaos; Gkiokas, Georgios; Kontis, Elissaios; Kozompoli, Dimitra; Papailia, Aspasia; Theodosopoulos, Theodosios; Bizios, Christol; Koutsikou, Anastasia; Moustaka, Aleaxandra; Plaitakis, Ioannis; Armaganidis, Apostolos; Christodoulopoulou, Theodora; Lignos, Mihail; Theodorakopoulou, Maria; Asimakos, Andreas; Ischaki, Eleni; Tsagkaraki, Angeliki; Zakynthinos, Spyros; Antoniadou, Eleni; Koutelidakis, Ioannis; Lathyris, Dimitrios; Pozidou, Irene; Voloudakis, Nikolaos; Dalamagka, Maria; Elena, Gkonezou; Chronis, Christos; Manolakaki, Dimitra; Mosxogiannidis, Dimitris; Slepova, Tatiana; Tsakiridou, Isaia-Sissy; Lampiri, Claire; Vachlioti, Anastasia; Panagiotakis, Christos; Sfyras, Dimitrios; Tsimpoukas, Fotios; Tsirogianni, Athanasia; Axioti, Elena; Filippopoulos, Andreas; Kalliafa, Elli; Kassavetis, George; Katralis, Petros; Komnos, Ioannis; Pilichos, Georgios; Ravani, Ifigenia; Totis, Antonis; Apagaki, Eymorfia; Efthymiadi, Andromachi; Kampagiannis, Nikolaos; Paraforou, Theoniki; Tsioka, Agoritsa; Georgiou, Georgios; Vakalos, Aristeidis; Bairaktari, Aggeliki; Charitos, Efthimios; Markou, George; Niforopoulou, Panagiota; Papakonstantinou, Nikolaos; Tsigou, Evdoxia; Xifara, Archontoula; Zoulamoglou, Menelaos; Gkioni, Panagiota; Karatzas, Stylianos; Kyparissi, Aikaterini; Mainas, Efstratios; Papapanagiotou, Ioannis; Papavasilopoulou, Theonymfi; Fragandreas, George; Georgopoulou, Eleni; Katsika, Eleni; Psarras, Kyriakos; Synekidou, Eirini; Verroiotou, Maria; Vetsiou, Evangelia; Zaimi, Donika; Anagnou, Athina; Apostolou, Konstantinos; Melissopoulou, Theodora; Rozenberg, Theophilos; Tsigris, Christos; Boutsikos, Georgios; Kalles, Vasileios; Kotsalas, Nikolaos; Lavdaiou, Christina; Paikou, Fotini; Panagou, Georgia-Laura; Spring, Anna; Botis, Ioannis; Drimala, Maria; Georgakakis, Georgios; Kiourtzieva, Ellada; Ntouma, Panagiota; Prionas, Apostolos; Xouplidis, Kyriakos; Dalampini, Eleftheria; Giannaki, Chrysavgi; Iasonidou, Christina; Ioannidis, Orestis; Lavrentieva, Athina; Lavrentieva, Athena; Papageorgiou, George; Kokkinoy, Maria; Stafylaraki, Maria; Gaitanakis, Stylianos; Karydakis, Periclis; Paltoglou, Josef; Ponireas, Panagiotis; Chaloulis, Panagiotis; Provatidis, Athanasios; Sousana, Anisoglou; Gardikou, Varvara Vanessa; Konstantivelli, Maria; Lataniotou, Olga; Lisari, Elisavet; Margaroni, Maria; Stamatiou, Konstantinos; Nikolaidis, Edouardos; Pnevmatikos, Ioannis; Sertaridou, Eleni; Andreou, Alexandros; Arkalaki, Eleni; Athanasakis, Elias; Chaniotaki, Fotini; Chatzimichali, Chatzimichali Aikaterini; Christofaki, Maria; Dermitzaki, Despina; Fiorentza, Klara; Frantzeskos, Georgios; Geromarkaki, Elisavet; Kafkalaki, Kalliopi; Kalogridaki, Marina; Karydi, Konstyllia; Kokkini, Sofia; Kougentakis, Georgios; Lefaki, Tatiana; Lilitsis, Emmanouhl; Makatounaki, Aikaterini; Malliotakis, Polychronis; Michelakis, Dimosthenis; Neonaki, Maria; Nyktari, Vasileia; Palikyra, Iliana; Papadakis, Eleftherios; Papaioannou, Alexandra; Sfakianakis, Konstantinos; Sgouraki, Maria; Souvatzis, Xenia; Spartinou, Anastasia; Stefanidou, Nefeli; Syrogianni, Paulina; Tsagkaraki, Georgia; Arnaoutoglou, Elena; Arnaoutoglou, Christina; Bali, Christina; Bouris, Vasilios; Doumos, Rodamanthos; Gkini, Konstantia-Paraskevi; Kapaktsi, Clio; Koulouras, Vasilios; Lena, Arian; Lepida, Dimitra; Michos, Evangelos; Papadopoulos, Dimitrios; Paschopoulos, Minas; Rompou, Vaia Aliki; Siouti, Ioanna; Tsampalas, Stavros; Ververidou, Ourania; Zilis, Georgios; Charlalampidoy, Alexandra; Christodoulidis, Gregory; Flossos, Andreas; Stamoulis, Konstantinos; Chan, Matthew; Tsang, Man Shing Caleb; Tsang, Man Shing; Lai, Man Ling; Yip, Chi Pang; Heymans Chan, Hey Man; Law, Bassanio; Li, Wing Sze; Chu, Hiu Man; Koo, Emily Gar Yee; Lam, Chi Cheong Joe; Cheng, Ka Ho; Lam, Tracy; Chu, Susanna; Lam, Wing Yan; Wong, Kin Wai Kevin; Kwok, Dilys; Hung, Ching Yue Janice; Chan, Wai Kit Jacky; Wong, Wing Lam; Chung, Chun Kwong Eric; Ma, Shu Kai; Kaushik, Shuchi; Shah, Bhagyesh; Shah, Dhiren; Shah, Sanjay; Ar, Praburaj; Muthuchellappan, Radhakrishnan; Agarwal, Vandana; Divatia, Jigeeshu; Mishra, Sanghamitra; Nimje, Ganesh; Pande, Swati; Savarkar, Sukhada; Shrivastava, Aditi; Thomas, Martin; Yegnaram, Shashikant; Hidayatullah, Rahmat; Puar, Nasman; Niman, Sumara; Indra, Imai; Hamzah, Zulkarnain; Yuliana, Annika; Abidin, Ucu Nurhadiat; Dursin, Ade Nurkacan; Kurnia, Andri; Susanti, Ade; Handayani, Dini; Alit, Mahaalit Aribawa; Arya, Aryabiantara; Senapathi, Tjokorda Gde Agung; Utara, Utara Hartawan; Wid, Widnyana Made; Wima, Semarawima; Wir, Wiryana Made; Jehosua, Brillyan; Kaunang, Jonathan; Lantang, Eka Yudha; Najoan, Rini; Waworuntu, Neil; Awad, Hadi; Fuad, Akram; Geddoa, Burair; Khalaf, Abdel Razzaq; Al Hussaini, Sabah; Albaj, Safauldeensalem; Kenber, Maithem; Bettinelli, Alessandra; Spadaro, Savino; AlbertoVolta, Carlo; Giancarlo, Luigi; Sottosanti, Vicari; Copetti, Elisa; Spagnesi, Lorenzo; Toretti, Ilaria; Alloj, Chiara; Cardellino, Silvano; Carmino, Livio; Costanzo, Eleonora; Fanfani, Lucia Caterina; Novelli, Maria Teresa; Roasio, Agostino; Bellandi, Mattia; Beretta, Luigi; Bignami, Elena; Bocchino, Speranza; Cabrini, Luca; Corti, Daniele; Landoni, Giovanni; Meroni, Roberta; Moizo, Elena; Monti, Giacomo; Pintaudi, Margherita; Plumari, Valentina Paola; Taddeo, Daiana; Testa, Valentina; Winterton, Dario; Zangrillo, Alberto; Cloro, Luigi Maria; Colangelo, Chiara; Colangelo, Antonio; Rotunno, Giuseppe; Paludi, Miguel Angel; Maria, Cloro Paolo; Pata, Antonio; Parrini, Vieri; Gatta, Alessandro; Nastasi, Mauro; Tinti, Carla; Baroselli, Antonio; Arrigo, Mario; Benevento, Angelo; Bottini, Corrado; Cannavo', Maurizio; Gastaldi, Christian; Marchesi, Alessandro; Pascazio, Angelantonio; Pata, Francesco; Pozzi, Emilio; Premoli, Alberto; Tessera, Gaetano; Boschi, Luca; D'Andrea, Rocco; Ghignone, Federico; Poggioli, Gilberto; Sibilio, Andrea; Taffurelli, Mario; Ugolini, Giampaolo; Ab Majid, Mohd Azuan; Ab Rahman, Rusnah; Joseph, James; Pathan, Furquan; Sybil Shah, Mohammad Hafizshah; Yap, Huey Ling; Cheah, Seleen; Chin, Im Im; Looi, Ji Keon; Tan, Siew Ching; Visvalingam, Sheshendrasurian; Kwok, Fan Yin; Lee, Chew Kiok; Tan, Tse Siang; Wong, Sze Meng; Abdullah, Noor Hairiza; Liew, Chiat Fong; Luxuman, Lovenia; Mohd Zin, Nor Hafizah; Norddin, Muhamad Faiz; Raja Alias, Raja Liza; Wong, Juan Yong; Yong, Johnny; Bin Mustapha, Mohd Tarmimi; Chan, Weng Ken; Dzulkipli, Norizawati; Kuan, Pei Xuan; Lee, Yew Ching; Alias, Anita; Guok, Eng Ching; Jee, Chiun Chen; Ramon, Brian Rhadamantyne; Wong, Cheng Weng; Abd Ghafar, Fara Nur Idayu; Aziz, Faizal Zuhri; Hussain, Nabilah; Lee, Hooi Sean; Sukawi, Ismawaty; Woon, Yuan Liang; Abd Hadi, Husni Zaeem; Ahmad Azam, Ummi Azmira; Alias, Abdul Hafiz; Kesut, Saiful Aizar; Lee, Jun May; Ooi, Dar Vin; Sulaiman, Hetty Ayuni; Lih, Tengku Alini Tengku; Veerakumaran, Jeyaganesh; Rojas, Eder; Resendiz, Gerardo Esteban Alvarez; Zapata, Darcy Danitza Mari; López, Julio Cesar Jesús Aguilar; Flores, Armando Adolfo Alvarez; Amador, Juan Carlos Bravo; Avila, Erendira Jocelin Dominguez; Aquino, Laura Patricia González; Rodriguez, Ricardo Lopez; Landa, Mariana Torres; Urias, Emma; Hollmann, Markus; Hulst, Abraham; Preckel, Benedikt; Koopman-van Gemert, Ankie; Buise, Marc; Tolenaar, Noortje; Weber, Eric; de Fretes, Jennifer; Houweling, Peter; Ormskerk, Patricia; van Bommel, Jasper; Lance, Marcus; Smit-Fun, Valerie; van Zundert, Tom; Baas, Peter; Donald de Boer, Hans; Sprakel, Joost; Elferink-Vonk, Renske; Noordzij, Peter; van Zeggeren, Laura; Brand, Bastiaan; Spanjersberg, Rob; ten Bokkel-Andela, Janneke; Numan, Sandra; van Klei, Wilton; van Zaane, Bas; Boer, Christa; van Duivenvoorde, Yoni; Hering, Jens Peter; van Rossum, Sylvia; Zonneveldt, Harry; Campbell, Doug; Hoare, Siobhan; Santa, Sahayam; Ali, Marlynn; Allen, Sara Jane; Bell, Rachel; Choi, Hyun-Min David; Drake, Matthew; Farrell, Helen; Hayes, Katia; Higgie, Kushlin; Holmes, Kerry; Jenkins, Nicole; Kim, Chang Joon; Kim, Steven; Law, Kiew Chai; McAllister, Davina; Park, Karen; Pedersen, Karen; Pfeifer, Leesa; Pozaroszczyk, Anna; Salmond, Timothy; Steynor, Martin; Tan, Michael; Waymouth, Ellen; Ab Rahman, Ahmad Sufian; Armstrong, John; Dudson, Rosie; Jenkins, Nia; Nilakant, Jayashree; Richard, Seigne; Virdi, Pardeep; Dixon, Liane; Donohue, Roana; Farrow, Mehreen; Kennedy, Ross; Marissa, Henderson; McKellow, Margie; Nicola, Delany; Pascoe, Rebecca; Roberts, Stephen John; Rowell, George; Sumner, Matthew; Templer, Paul; Chandrasekharan, Shardha; Fulton, Graham; Jammer, Ib; More, Richard; Wilson, Leona; Chang, Yuan Hsuan; Foley, Julia; Fowler, Carolyn; Panckhurst, Jonathan; Sara, Rachel; Stapelberg, Francois; Cherrett, Veronica; Ganter, Donna Louise; McCann, Lloyd; Gilmour, Fiona; Lumsden, Rachelle; Moores, Mark; Olliff, Sue; Sardareva, Elitza; Tai, Joyce; Wikner, Matthew; Wong, Christopher; Chaddock, Mark; Czepanski, Carolyn; McKendry, Patrick; Polakovic, Daniel; Polakovich, Daniel; Robert, Axe; Belda, Margarita Tormo; Norton, Tracy; Alherz, Fadhel; Barneto, Lisa; Ramirez, Alberto; Sayeed, Ahmed; Smith, Nicola; Bennett, Cambell; McQuoid, Shane; Jansen, Tracy-Lee; Nico, Zin; Scott, John; Freschini, David; Freschini, Angela; Hopkins, Brian; Manson, Lara; Stoltz, Deon; Bates, Alexander; Davis, Simon; Freeman, Victoria; McGaughran, Lynette; Williams, Maya; Sharma, Swarna Baskar; Burrows, Tom; Byrne, Kelly; English, Duane; Johnson, Robert; Manikkam, Brendon; Naidoo, Shaun; Rumball, Margot; Whittle, Nicola; Franks, Romilla; Gibson-Lapsley, Hannah; Salter, Ryan; Walsh, Dean; Cooper, Richard; Perry, Katherine; Obobolo, Amos; Sule, Umar Musa; Ahmad, Abdurrahman; Atiku, Mamuda; Mohammed, Alhassan Datti; Sarki, Adamu Muhammad; Adekola, Oyebola; Akanmu, Olanrewaju; Durodola, Adekunle; Olukoju, Olusegun; Raji, Victor; Olajumoke, Tokunbo; Oyebamiji, Emmanuel; Adenekan, Anthony; Adetoye, Adedapo; Faponle, Folayemi; Olateju, Simeon; Owojuyigbe, Afolabi; Talabi, Ademola; Adenike, Odewabi; Adewale, Badru; Collins, Nwokoro; Ezekiel, Emmanuel; Fatungase, Oluwabunmi Motunrayo; Grace, Anuforo; Sola, Sotannde; Stella, Ogunmuyiwa; Ademola, Adeyinka; Adeolu, Augustine A.; Adigun, Tinuola; Akinwale, Mukaila; Fasina, Oluyemi; Gbolahan, Olalere; Idowu, Olusola; Olonisakin, Rotimi Peter; Osinaike, Babatunde Babasola; Asudo, Felicia; Mshelia, Danladi; Abdur-Rahman, Lukman; Agodirin, Olayide; Bello, Jibril; Bolaji, Benjamin; Oyedepo, Olanrewaju Olubukola; Ezike, Humphrey; Iloabachie, Ikechukwu; Okonkwo, Ikemefuna; Onuora, Elias; Onyeka, Tonia; Ugwu, Innocent; Umeh, Friday; Alagbe-Briggs, Olubusola; Dodiyi-Manuel, Amabra; Echem, Richard; Obasuyi, Bright; Onajin-Obembe, Bisola; Bandeira, Maria Expedito; Martins, Alda; Tomé, Miguel; Costa, Ana Cristina Miranda Martins; Krystopchuk, Andriy; Branco, Teresa; Esteves, Simao; Melo, Marco António; Monte, Júlia; Rua, Fernando; Martins, Isabel; Pinho-Oliveira, Vítor Miguel; Rodrigues, Carla Maria; Cabral, Raquel; Marques, Sofia; Rêgo, Sara; Jesus, Joana Sofia Teixeira; Marques, Maria Conceição; Romao, Cristina; Dias, Sandra; Santos, Ana Margarida; Alves, Maria Joao; Salta, Cristina; Cruz, Salome; Duarte, Célia; Paiva, António Armando Furtado; Cabral, Tiago do Nascimento; Faria E Maia, Dionisio; Correia da Silva, Rui Freitas Mendonça; Langner, Anuschka; Resendes, Hernâni Oliveira; Soares, Maria da Conceição; Abrunhosa, Alexandra; Faria, Filomena; Miranda, Lina; Pereira, Helena; Serra, Sofia; Ionescu, Daniela; Margarit, Simona; Mitre, Calin; Vasian, Horatiu; Manga, Gratiela; Stefan, Andreea; Tomescu, Dana; Filipescu, Daniela; Paunescu, Marilena-Alina; Stefan, Mihai; Stoica, Radu; Gavril, Laura; Pătrășcanu, Emilia; Ristescu, Irina; Rusu, Daniel; Diaconescu, Ciresica; Iosep, Gabriel Florin; Pulbere, Dorin; Ursu, Irina; Balanescu, Andreea; Grintescu, Ioana; Mirea, Liliana; Rentea, Irina; Vartic, Mihaela; Lupu, Mary-Nicoleta; Stanescu, Dorin; Streanga, Lavinea; Antal, Oana; Hagau, Natalia; Patras, Dumitru; Petrisor, Cristina; Tosa, Flaviu; Tranca, Sebastian; Copotoiu, Sanda Maria; Ungureanu, Liviu Lucian; Harsan, Cristian Remus; Papurica, Marius; Cernea, Daniela Denisa; Dragoescu, Nicoleta Alice; CarmenVaida, Laura Aflori; Ciobotaru, Oana Roxana; Aignatoaie, Mariana; Carp, Cristina Paula; Cobzaru, Isabelle; Mardare, Oana; Purcarin, Bianca; Tutunaru, Valentin; Ionita, Victor; Arustei, Mirela; Codita, Anisoara; Busuioc, Mihai; Chilinciuc, Ion; Ciobanu, Cristina; Belciu, Ioana; Tincu, Eugen; Blaj, Mihaela; Grosu, Ramona-Mihaela; Sandu, Gigel; Bruma, Dana; Corneci, Dan; Dutu, Madalina; Krepil, Adriana; Copaciu, Elena; Dumitrascu, Clementina Oana; Jemna, Ramona; Mihaescu, Florentina; Petre, Raluca; Tudor, Cristina; Ursache, Elena; Kulikov, Alexander; Lubnin, Andrey; Grigoryev, Evgeny; Pugachev, Stanislav; Tolmasov, Alexander; Hussain, Ayyaz; Ilyina, Yana; Roshchina, Anna; Iurin, Aleksandr; Chazova, Elena; Dunay, Artem; Karelov, Alexey; Khvedelidze, Irina; Voldaeva, Olga; Belskiy, Vladislav; Dzhamullaev, Parvin; Grishkowez, Elena; Kretov, Vladimir; Levin, Valeriy; Molkov, Aleksandr; Puzanov, Sergey; Samoilenko, Aleksandr; Tchekulaev, Aleksandr; Tulupova, Valentina; Utkin, Ivan; Allorto, Nikki Leigh; Bishop, David Gray; Builu, Pierre Monji; Cairns, Carel; Dasrath, Ashish; de Wet, Jacques; Hoedt, Marielle den; Grey, Ben; Hayes, Morgan Philip; Küsel, Belinda Senta; Shangase, Nomcebo; Wise, Robert; Cacala, Sharon; Farina, Zane; Govindasamy, Vishendran; Kruse, Carl-Heinz; Lee, Carolyn; Marais, Leonard; Naidoo, Thinagrin Dhasarthun; Rajah, Chantal; Rodseth, Reitze Nils; Ryan, Lisa; von Rhaden, Richard; Adam, Suwayba; Alphonsus, Christella; Ameer, Yusuf; Anderson, Frank; Basanth, Sujith; Bechan, Sudha; Bhula, Chettan; Biccard, Bruce M.; Biyase, Thuli; Buccimazza, Ines; Cardosa, Jorge; Chen, James; Daya, Bhavika; Drummond, Leanne; Elabib, Ali; Abdel Goad, Ehab Helmy; Goga, Ismail E.; Goga, Riaz; Harrichandparsad, R.; Hodgson, Richard E.; Jordaan, J.; Kalafatis, Nicky; Kampik, Christian; Landers, A. T.; Loots, Emil; Madansein, Rajhmum; Madaree, Anil; Madiba, Thandinkosi E.; Manzini, Vukani T.; Mbuyisa, Mbali; Moodley, Rajan; Msomi, Mduduzi; Mukama, Innocent; Naidoo, Desigan; Naidoo, Rubeshan; Naidu, Tesuven K.; Ntloko, Sindiswa; Padayachee, Eneshia; Padayachee, Lucelle; Phaff, Martijn; Pillay, Bala; Pillay, Desigan; Pillay, Lutchmee; Ramnarain, Anupa; Ramphal, Suren R.; Ryan, Paul; Saloojee, Ahmed; Sebitloane, Motshedisi; Sigcu, Noluyolo; Taylor, Jenna L.; Torborg, Alexandra; Visser, Linda; Anderson, Philip; Conradie, Alae; de Swardt, Mathew; de Villiers, Martin; Eikman, Johan; Liebenberg, Riaan; Mouton, Johan; Paton, Abbey; van der Merwe, Louwrence; Wilscott-Davids, Candice; Barrett, Wendy Joan; Bester, Marlet; de Beer, Johan; Geldenhuys, Jacques; Gouws, Hanni; Potgieter, Jan-Hendrik; Strydom, Magdel; WilberforceTurton, Edwin; Chetty, Rubendraj R.; Chirkut, Subash; Cronje, Larissa; de Vasconcellos, Kim; Dube, Nokukhanya Z.; Gama, N. Sibusiso; Green, Garyth M.; Green-Thompson, Randolph; Kinoo, Suman Mewa; Kistnasami, Prenolin; Maharaj, Kapil; Moodley, Manogaran S.; Mothae, Sibongile J.; Naidoo, Ruvashni; Aslam F Noorbhai, M.; Rughubar, Vivesh; Reddy, Jenendhiran; Singh, Avesh; Skinner, David L.; Smith, Murray J.; Singh, Bhagwan; Misra, Ravi; Naidoo, Maheshwar; Ramdharee, Pireshin; Selibea, Yvonne; Sewpersad, Selina; Sham, Shailendra; Wessels, Joseph D.; Africander, Cucu; Bejia, Tarek; Blakemore, Stephen P.; Botes, Marisa; Bunwarie, Bimalshakth; Hernandez, Carlos B.; Jeeraz, Mohammud A.; Legutko, Dagmara A.; Lopez, Acela G.; de Meyer, Jenine N.; Muzenda, Tanaka; Naidoo, Noel; Patel, Maryam; Pentela, Rao; Junge, Marina; Mansoor, Naj; Rademan, Lana; Scislowski, Pawel; Seedat, Ismail; van den Berg, Bianca; van der Merwe, Doreen; van Wyk, Steyn; Govender, Komalan; Naicker, Darshan; Ramjee, Rajesh; Saley, Mueen; Kuhn, Warren Paul; Matos-Puig, Roel; Alberto Lisi, Zaheer Moolla; Perez, Gisela; Beltran, Anna Valle; Lozano, Angels; Navarro, Carlos Delgado; Duca, Alejandro; Ernesto, Ernesto Pastor Martinez; Ferrando, Carlos; Fuentes, Isabel; García-Pérez, Maria Luisa; Gracia, Estefania; Palomares, Ana Izquierdo; Katime, Antonio; Miñana, Amanda; Incertis, Raul Raul; Romero, Esther; Romero Garcia, Carolina Soledad; Rubio, Concepcion; Artiles, Tania Socorro; Soro, Marina; Valls, Paola; Laguarda, Gisela Alaman; Benavent, Pau; Cuenca, Vicente Chisbert; Cueva, Andreu; Lafuente, Matilde; Parra, Asuncion Marques; Rodrigo, Alejandra Romero; Sanchez-Morcillo, Silvia; Tormo, Sergi; Redondo, Francisco Javier; de Andrés Ibanez, José Antonio; Diago, Lorena Gómez; José Hernández Cádiz, Maria; Manuel, Granell Gil; Peris, Raquel; Saiz, Cristina; Vivo, Jose Tatay; Soto, Maria Teresa Tebar; Brunete, Tamara; Cancho, David; Delgado García, David R.; Zamudio, Diana; del Valle, Santiago Garcia; Serrano, M. Luz; Alonso, Eduardo; Anillo, Victor; Maseda, Emilio; Salgado, Patricia; Suarez, Luis; Suarez-de-la-Rica, Alejandro; Villagrán, María José; Alonso, José Ignacio; Cabezuelo, Estefania; Garcia-Saiz, Irene; Lopez del Moral, Olga; Martín, Silvia; Gonzalez, Alba Perez; Doncel, Ma Sherezade Tovar; Vera, Martin Agüero; José Ávila Sánchez, Francisco; Castaño, Beatriz; Moreira, Beatriz Castaño; Risco, Sahely Flores; Martín, Daniel Paz; Martín, Fernando Pérez; Poza, Paloma; Ruiz, Adela; Serna Martínez, Wilson Fabio; Vicente, Bárbara Vázquez; Dominguez, Saul Velaz; Fernández, Salvador; Munoz-López, Alfonso; Bernat, Maria Jose; Mas, Arantxa; Planas, Kenneth; Jawad, Monir; Saeed, Yousif; Hedin, Annika; Levander, Helena; Holmström, Sandra; Lönn, David; Zoerner, Frank; Åkring, Irene; Widmark, Carl; Zettergren, Jan; Liljequist, Victor Aspelund; Nystrom, Lena; Odeberg-Wernerman, Suzanne; Oldner, Anders; Fagerlund, Malin Jonsson; Reje, Patrik; Lyckner, Sara; Sperber, Jesper; Adolfsson, Anne; Klarin, Bengt; Ögren, Katrin; Barras, Jean-Pierre; Bührer, Thomas; Despotidis, Vasileios; Helmy, Naeder; Holliger, Stephan; Raptis, Dimitri Aristotle; Schmid, Roger; Meyer, Antoine; Jaquet, Yves; Kessler, Ulf; Muradbegovic, Mirza; Nahum, Solange R.; Rotunno, Teresa; Schiltz, Boris; Voruz, François; Worreth, Marc; Christoforidis, Dimitri; Popeskou, Sotirios Georgios; Furrer, Markus; Prevost, Gian Andrea; Stocker, Andrea; Lang, Klaus; Breitenstein, Stefan; Ganter, Michael T.; Geisen, Martin; Soll, Christopher; Korkmaz, Michelle; Lubach, Iris; Schmitz, Michael; Meyer Zu Schwabedissen, Moritz; Moritz, Meyer Zu Schwabedissen; Zingg, Urs; Hillermann, Thomas; Wildi, Stefan; Pinto, Bernardo Bollen; Walder, Bernhard; Mariotti, Giustina; Slankamenac, Ksenija; Namuyuga, Mirioce; Kyomugisha, Edward; Kituuka, Olivia; Shikanda, Anne Wesonga; Kakembo, Nasser; Tom, Charles Otim; Antonina, Webombesa; Bua, Emmanuel; Ssettabi, Eden Michael; Epodoi, Joseph; Kabagenyi, Fiona; Kirya, Fred; Dempsey, Ged; Seasman, Colette; Nawaz Khan, Raja Basit; Kurasz, Claire; Macgregor, Mark; Shawki, Burhan; Francis, Daren; Hariharan, Vimal; Chau, Simon; Ellis, Kate; Butt, Georgina; Chicken, Dennis-Wayne; Christmas, Natasha; Allen, Samantha; Daniel, Gayatri Daniel; Dempster, Angie; Kemp, Juliette; Matthews, Lewis; Mcglone, Philip; Tambellini, Joanne; Trodd, Dawn; Freitas, Katie; Garg, Atul; Gupta, Janesh Kumar; Karpate, Shilpaja; Kulkarni, Aditi; O'Hara, Chloe; Troko, Jtroko; Angus, Kirsty; Bradley, Jacqueline; Brennan, Emma; Brooks, Carolyn; Brown, Janette; Brown, Gemma; Finch, Amanda; Gratrix, Karen; Hesketh, Sue; Hill, Gillian; Jeffs, Carol; Morgan, Maureen; Pemberton, Chris; Slawson, Nicola; Spickett, Helen; Swarbrick, Gemma; Thomas, Megan; van Duyvenvoorde, Greta; Brennan, Andrew; Briscoe, Richard; Cooper, Sarah; Lawton, Tom; Northey, Martin; Senaratne, Rashmi; Stanworth, Helen; Burrows, Lorna; Cain, Helen; Craven, Rachael; Davies, Keith; Jonas, Attila; Pachucki, Marcin; Walkden, Graham; Davies, Helen; Gudaca, Mariethel; Hobrok, Maria; Arawwawala, Dilshan; Fergey, Lauren; Gardiner, Matthew; Gunn, Jacqueline; Johnson, Lyndsay; Lofting, Amanda; Lyle, Amanda; Neela, Fiona Mc; Smolen, Susan; Topliffe, Joanne; Williams, Sarah; Bland, Martin; Balaji, Packianathaswamy; Kaura, Vikas; Lanka, Prasad; Smith, Neil; Ahmed, Ahmed; Myatt, John; Shenoy, Ravikiran; Soon, Wai Cheong; Tan, Jessica; Karadia, Sunny; Self, James; Durant, Emma; Tripathi, Shiva; Bullock, Clare; Campbell, Debbie; Ghosh, Alison; Hughes, Thomas; Zsisku, Lajos; Bengeri, Sheshagiri; Cowton, Amanda; Khalid, Mohammed Shazad; Limb, James; McAdam, Colin; Porritt, Mandy; Rafi, M. Amir; Shekar, Priya; Adams, David; Harden, Catherine; Hollands, Heidi; King, Angela; March, Linda; Minto, Gary; Patrick, Abigail; Squire, Rosalyn; Waugh, Darren; Kumara, Paramesh; Simeson, Karen; Yarwood, Jamie; Browning, Julie; Hatton, Jonathan; Julian, Howes; Mitra, Atideb; Newton, Maria; Pernu, Pawan Kootelu; Wilson, Alison; Commey, Thelma; Foot, Helen; Glover, Lyn; Gupta, Ajay; Lancaster, Nicola; Levin, Jill; Mackenzie, Felicity; Mestanza, Claire; Nofal, Emma; Pout, Lauren; Varden, Rosanna; Wild, Jonathan; Jones, Stephanie; Moreton, Sarah; Pulletz, Mark; Davies, Charlotte; Martin, Matthew; Thomas, Sian; Burns, Karen; McArthur, Carol; Patel, Panna; Lau, Gary; Rich, Natalie; Davis, Fiona; Lyons, Rachel; Port, Beth; Prout, Rachel; Smith, Christopher; Adelaja, Yemi; Bennett, Victoria; Bidd, Heena; Dumitrescu, Alexandra; Murphy, Jacqui Fox; Keen, Abigail; Mguni, Nhlanhla; Ong, Cheng; Adams, George; Boshier, Piers; Brown, Richard; Butryn, Izabella; Chatterjee, Jayanta; Freethy, Alexander; Lockwood, Geoffrey; Tsakok, Maria; Tsiligiannis, Sophia; Peat, William; Stephenson, Lorraine; Bradburn, Mike; Pick, Sara; Cunha, Pedro; Olagbaiye, Olufemi; Tayeh, Salim; Packianathaswamy, Balaji; Abernethy, Caroline; Balasubramaniam, Madhu; Bennett, Rachael; Bolton, David; Martinson, Victoria; Naylor, Charde; Bell, Stephanie; Heather, Blaylock; Kushakovsky, Vlad; Alcock, Liam; Alexander, Hazel; Anderson, Colette; Baker, Paul; Brookes, Morag; Cawthorn, Louise; Cirstea, Emanuel; Clarkson, Rachel; Colling, Kerry; Coulter, Ian; Das, Suparna; Haigh, Kathryn; Hamdan, Alhafidz; Hugill, Keith; Kottam, Lucksy; Lisseter, Emily; Mawdsley, Matthew; McGivern, Julie; Padala, Krishnaveni; Phelps, Victoria; Ramesh Kumar, Vineshykaa; Stewart, Kirsten; Towse, Kayley; Tregonning, Julie; Vahedi, Ali; Walker, Alycon; Baines, Duncan; Bilolikar, Anjali; Chande, Shiv; Copley, Edward; Dunk, Nigel; Kulkarni, Raghavendra; Kumar, Pawan; Metodiev, Yavor; Ncomanzi, Dumisani; Raithatha, Bhavesh; Raymode, Parizade; Szafranski, Jan; Twohey, Linda; Watt, Philip; Weatherall, Lucie; Weatherill, J.; Whitman, Zoe; Wighton, Elinor; Abayasinghe, Chamika; Chan, Alexander; Darwish, Sharif; Gill, James; Glasgow, Emma; Hadfield, Daniel; Harris, Clair; Hopkins, Phil; Kochhar, Arun; Kunst, Gudrun; Mellis, Clare; Pool, Andrew; Riozzi, Paul; Selman, Andrew; Smith, Emma-Jane; Vele, Liana; Gercek, Yuksel; Guy, Kramer; Holden, Douglas; Watson, Nicholas; Whysall, Karen; Andreou, Prematie; Hales, Dawn; Thompson, Jonathan; Bowrey, Sarah; McDonald, Shara; Gilmore, Jemma; Hills, Vicky; Kelly, Chan; Kelly, Sinead; Lloyd, Geraint; Abbott, Tom; Gall, Lewis; Torrance, Hew; Vivian, Mark; Berntsen, Emer; Nolan, Tracey; Turner, Angus; Vohra, Akbar; Brown, Andrew; Clark, Richard; Coughlan, Elaine; Daniel, Conway; Patvardhan, Chinmay; Pearson, Rachel; Predeep, Sheba; Saad, Hesham; Shanmugam, Mohanakrishnan; Varley, Simon; Wylie, Katharine; Cooper, Lucy; Makowski, Arystarch; Misztal, Beata; Moldovan, Eliza; Pegg, Claire; Donovan, Andrew; Foot, Jayne; Large, Simon; Claxton, Andrew; Netke, Bhagyashree; Armstrong, Richard; Calderwood, Claire; Kwok, Andy; Mohr, Otto; Oyeniyi, Peter; Patnaik, Lisa; Post, Benjamin; Ali, Sarah; Arshad, Homa; Baker, Gerard; Brenner, Laura; Brincat, Maximilian; Brunswicker, Annemarie; Cox, Hannah; Cozar, Octavian Ionut; Cheong, Edward; Durst, Alexander; Fengas, Lior; Flatt, Jim; Glister, Georgina; Narwani, Vishal; Photi, Evangelos; Rankin, Adeline; Rosbergen, Melissa; Tan, Mark; Beaton, Ceri; Horn, Rachel; Hunt, Jane; Rousseau, Guy; Stancombe, Lucia; Absar, Mohammed; Allsop, Joanne; Drinkwater, Zoe; Hodgkiss, Tracey; Smith, Kirsty; Brown, Jamie; Alexander-Sefre, Farhad; Campey, Lorraine; Dudgeon, Lucy; Hall, Kathryn; Hitchcock, Rachael; James, Lynne; Smith, Kate; Winstone, Ulrika; Ahmad, Norfaizan; Bauchmuller, Kris; Harrison, Jonathan; Jeffery, Holly; Miller, Duncan; Pinder, Angela; Pothuneedi, Sailaja; Rosser, Jonathan; Sanghera, Sumayer; Swift, Diane; Walker, Rachel; Bester, Delia; Cavanagh, Sarah; Cripps, Heather; Daniel, Harvey; Lynch, Julie; Paton, Alison; Pyke, Shirley; Scholefield, John; Whitworth, Helen; Bottrill, Fiona; Ramalingam, Ganesh; Webb, Stephen; Akerman, Nik; Antill, Philip; Bourner, Lynsey; Buckley, Sarah; Castle, Gail; Charles, Rob; Eggleston, Christopher; Foster, Rebecca; Gill, Satwant; Lindley, Kate; Lklouk, Mohamed; Lowery, Tracey; Martin, Oliver; Milne, David; O'Connor, Patrick; Ratcliffe, Andrew; Rose, Alastair; Smith, Annie; Varma, Sandeep; Ward, Jackie; Barcraft-Barnes, Helena; Camsooksai, Julie; Colvin, Carolyn; Reschreiter, Henrik; Tbaily, Lee; Venner, Nicola; Hamilton, Caroline; Kelly, Lewis; Toth-Tarsoly, Piroska; Dodsworth, Kerry; Foord, Denise; Gordon, Paul; Hawes, Elizabeth; Lamb, Nikki; Mouland, Johanna; Nightingale, Jeremy; Rose, Steve; Schrieber, Joe; Al'Amri, Khalid; Aladin, Hafiz; Arshad, Mohammed Asif; Barraclough, James; Bentley, Conor; Bergin, Colin; Carrera, Ronald; Clarkson, Aisling; Collins, Michelle; Cooper, Lauren; Denham, Samuel; Griffiths, Ewen; Ip, Peter; Jeyanthan, Somasundaram; Joory, Kavita; Kaur, Satwant; Marriott, Paul; Mitchell, Natalie; Nagaiah, Sukumar; Nilsson, Annette; Parekh, Nilesh; Pope, Martin; Seager, Joseph; Serag, Hosam; Tameem, Alifia; Thomas, Anna; Thunder, Joanne; Torrance, Andrew; Vohra, Ravinder; Whitehouse, Arlo; Wong, Tony; Blunt, Mark; Wong, Kate; Giles, Julian; Reed, Isabelle; Weller, Debbie; Bell, Gillian; Birch, Julie; Damant, Rose; Maiden, Jane; Mewies, Clare; Prince, Claire; Radford, Jane; Reynolds, Tim; Balain, Birender; Banerjee, Robin; Barnett, Andrew; Burston, Ben; Davies, Kirsty; Edwards, Jayne; Evans, Chris; Ford, David; Gallacher, Pete; Hill, Simon; Jaffray, David; Karlakki, Sudheer; Kelly, Cormac; Kennedy, Julia; Kiely, Nigel; Lewthwaite, Simon; Marquis, Chris; Ockendon, Matthew; Phillips, Stephen; Pickard, Simon; Richardson, James; Roach, Richard; Smith, Tony; Spencer-Jones, Richard; Steele, Niall; Steen, Julie; van Liefland, Marck; White, Steve; Faulds, Matthew; Harris, Meredyth; Kelly, Carrie; Nicol, Scott; Pearson, Sally Anne; Chukkambotla, Srikanth; Andrew, Alyson; Attrill, Elizabeth; Campbell, Graham; Datson, Amanda; Fouracres, Anna; Graterol, Juan; Graves, Lynne; Hong, Bosun; Ishimaru, Alexander; Karthikeyan, Arvind; King, Helen; Lawson, Tom; Lee, Gregory; Lyons, Saoirse; Hall, Andrew Macalister; Mathoulin, Sophie; Mcintyre, Eilidh; Mclaughlin, Danny; Mulcahy, Kathleen; Paddle, Jonathan; Ratcliffe, Anna; Robbins, James; Sung, Weilin; Tayo, Adeoluwa; Trembath, Lisa; Venugopal, Suneetha; Walker, Robert; Wigmore, Geoffrey; Boereboom, Catherine; Downes, Charlotte; Humphries, Ryan; Melbourne, Susan; Smith, Coral; Tou, Samson; Ullah, Shafa; Batchelor, Nick; Boxall, Leigh; Broomby, Rupert; Deen, Tariq; Hellewell, Alistair; Helliwell, Laurence; Hutchings, Melanie; Hutchins, David; Keenan, Samantha; Mackie, Donna; Potter, Alison; Smith, Frances; Stone, Lucy; Thorpe, Kevin; Wassall, Richard; Woodgate, Andrew; Baillie, Shelley; Campbell, Tara; James, Sarah; King, Chris; Marques de Araujo, Daniela; Martin, Daniel; Morkane, Clare; Neely, Julia; Rajendram, Rajkumar; Burton, Megan; James, Kathryn; Keevil, Edward; Minik, Orsolya; Morgan, Jenna; Musgrave, Anna; Rajanna, Harish; Roberts, Tracey; Adamson, Michael; Jumbe, Sandra; Kendall, Jennie; Muthuswamy, Mohan Babu; Anderson, Charlotte; Cruikshanks, Andrew; Wrench, Ian; Zeidan, Lisa; Ardern, Diane; Harris, Benjamin; Hellstrom, Johanna; Martin, Jane; Thomas, Richard; Varsani, Nimu; Brown, Caroline Wrey; Docherty, Philip; Gillies, Michael; McGregor, Euan; Usher, Helen; Craig, Jayne; Smith, Andrew; Ahmad, Tahania; Bodger, Phoebe; Creary, Thais; Fowler, Alexander; Hewson, Russ; Ijuo, Eke; Jones, Timothy; Kantsedikas, Ilya; Lahiri, Sumitra; McLean, Aaron Lawson; Niebrzegowska, Edyta; Phull, Mandeep; Wang, Difei; Wickboldt, Nadine; Baldwin, Jacqueline; Doyle, Donna; Mcmullan, Sean; Oladapo, Michelle; Owen, Thomas; Williams, Alexandra; Daniel, Hull; Gregory, Peter; Husain, Tauqeer; Kirk-Bayley, Justin; Mathers, Edward; Montague, Laura; Harper, Mark; White, Stuart; Jack, James; Ridley, Carrie; Avis, Joanne; Cook, Tim; Dali-Kemmery, Lola; Kerslake, Ian; Lambourne, Victoria; Pearson, Annabel; Boyd, Christine; Callaghan, Mark; Lawson, Cathy; McCrossan, Roopa; Nesbitt, Vanessa; O'connor, Laura; Scott, Julia; Sinclair, Rhona; Farid, Nahla; Morgese, Ciro; Bhatia, Kailash; Karmarkar, Swati; Ahmed, Jamil; Branagan, Graham; Hutton, Monica; Swain, Andrew; Brookes, Jamie; Cornell, Jonathan; Dolan, Rachael; Hulme, Jonathan; Jansen van Vuuren, Amanda; Jowitt, Tom; Kalashetty, Gunasheela; Lloyd, Fran; Patel, Kiran; Sherwood, Nicholas; Brown, Lynne; Chandler, Ben; Deighton, Kerry; Emma, Temlett; Haunch, Kirsty; Cheeseman, Michelle; Dent, Kathy; Garg, Sanjeev; Gray, Carol; Hood, Marion; Jones, Dawn; Juj, Joanne; Rao, Roshan; Walker, Tara; Al Anizi, Mashel; Cheah, Clarissa; Cheing, Yushio; Coutinho, Francisco; Gondo, Prisca; Hadebe, Bernard; Hove, Mazvangu Onie; Khader, Ahamed; Krishnachetty, Bobby; Rhodes, Karen; Sokhi, Jagdish; Baker, Katie-Anne; Bertram, Wendy; Looseley, Alex; Mouton, Ronelle; Hanna, George; Arnold, Glenn; Arya, Shobhit; Balfoussia, Danai; Baxter, Linden; Harris, James; Jones, Craig; Knaggs, Alison; Markar, Sheraz; Perera, Anisha; Scott, Alasdair; Shida, Asako; Sirha, Ravneet; Wright, Sally; Frost, Victoria; Gray, Catherine; Andrews, Emma; Arrandale, Lindsay; Barrett, Stephen; Cifra, Elna; Cooper, Mariese; Dragnea, Dragos; Elna, Cifra; Maclean, Jennifer; Meier, Sonja; Milliken, Donald; Munns, Christopher; Ratanshi, Nadir; Ramessur, Suneil; Salvana, Abegail; Watson, Anthony; Ali, Hani; Campbell, Gill; Critchley, Rebecca; Endersby, Simon; Hicks, Catherine; Liddle, Alison; Pass, Marc; Ritchie, Charlotte; Thomas, Charlotte; Too, Lingxi; Welsh, Sarah; Gill, Talvinder; Johnson, Joanne; Reed, Joanne; Davis, Edward; Papadopoullos, Sam; Attwood, Clare; Biffen, Andrew; Boulton, Kerenza; Gray, Sophie; Hay, David; Mills, Sarah; Montgomery, Jane; Riddell, Rory; Simpson, James; Bhardwaj, Neeraj; Paul, Elaine; Uwubamwen, Nosakhare; Alexander, Maini; Arrich, James; Arumugam, Swarna; Blackwood, Douglas; Boggiano, Victoria; Brown, Robyn; Chan, Yik Lam; Chatterjee, Devnandan; Chhabra, Ashok; Christian, Rachel; Costelloe, Hannah; Matthewman, Madeline Coxwell; Dalton, Emma; Darko, Julia; Davari, Maria; Dave, Tejal; Deacon, Matthew; Deepak, Shantal; Edmond, Holly; Ellis, Jessica; El-Sayed, Ahmed; Eneje, Philip; English, Rose; Ewe, Renee; Foers, William; Franklin, John; Gallego, Laura; Garrett, Emily; Goldberg, Olivia; Goss, Harry; Greaves, Rosanna; Harris, Rudy; Hennings, Charles; Jones, Eleanor; Kamali, Nelson; Kokkinos, Naomi; Lewis, Carys; Lignos, Leda; Malgapo, Evaleen Victoria; Malik, Rizwana; Milne, Andrew; Mulligan, John-Patrick; Nicklin, Philippa; Palipane, Natasha; Parsons, Thomas; Piper, Rebecca; Prakash, Rohan; Ramesh, Byron; Rasip, Sarah; Reading, Jacob; Rela, Mariam; Reyes, Anna; Stephens, Robert; Rooms, Martin; Shah, Karishma; Simons, Henry; Solanki, Shalil; Spowart, Emma; Stevens, Amy; Thomas, Christopher; Waggett, Helena; Yassaee, Arrash; Kennedy, Anthony; Scott, Sara; Somanath, Sameer; Berg, Andrew; Hernandez, Miguel; Nanda, Rajesh; Tank, Ghanshyambhai; Wilson, Natalie; Wilson, Debbie; Al-Soudaine, Yassr; Baldwin, Matthew; Cornish, Julie; Davies, Zoe; Davies, Leigh; Edwards, Marc; Frewer, Natasha; Gallard, Sian; Glasbey, James; Harries, Rhiannon; Hopkins, Luke; Kim, Taeyang; Koompirochana, Vilavan; Lawson, Simon; Lewis, Megan; Makzal, Zaid; Scourfield, Sarah; Ahmad, Yousra; Bates, Sarah; Blackwell, Clare; Bryant, Helen; Collins, Hannah; Coulter, Suzanne; Cruickshank, Ross; Daniel, Sonya; Daubeny, Thomas; Edwards, Mark; Golder, Kim; Hawkins, Lesley; Helen, Bryant; Hinxman, Honor; Levett, Denny; Salmon, Karen; Seaward, Leanne; Skinner, Ben; Tyrell, Bryony; Wadams, Beverley; Walsgrove, Joseph; Dickson, Jane; Constantin, Kathryn; Karen, Markwell; O'Brien, Peter; O'Donohoe, Lynn; Payne, Hannah; Sundayi, Saul; Walker, Elaine; Brooke, Jenny; Cardy, Jon; Humphreys, Sally; Kessack, Laura; Kubitzek, Christiane; Kumar, Suhas; Cotterill, Donna; Hodzovic, Emil; Hosdurga, Gurunath; Miles, Edward; Saunders, Glenn; Campbell, Marta; Chan, Peter; Jemmett, Kim; Raj, Ashok; Naik, Aditi; Oshowo, Ayo; Ramamoorthy, Rajarajan; Shah, Nimesh; Sylvan, Axel; Blyth, Katharine; Burtenshaw, Andrew; Freeman, David; Johnson, Emily; Lo, Philip; Martin, Terry; Plunkett, Emma; Wollaston, Julie; Allison, Joanna; Carroll, Christine; Craw, Nicholas; Craw, Sarah; Pitt-Kerby, Tressy; Rowland-Axe, Rebecca; Spurdle, Katie; McDonald, Andrew; Simon, Davies; Sinha, Vivek; Smith, Thomas; Banner-Goodspeed, Valerie; Boone, Myles; Campbell, Kathleen; Lu, Fengxin; Scannell, Joseph; Sobol, Julia; Balajonda, Naraida; Clemmons, Karen; Conde, Carlos; Elgasim, Magdi; Funk, Bonita; Hall, Roger; Hopkins, Thomas; Olaleye, Omowunmi; Omer, Omer; Pender, Michelle; Porto, Angelo; Stevens, Alice; Waweru, Peter; Yeh, Erlinda; Bodansky, Daniella; Evans, Adam; Kleopoulos, Steven; Maril, Robert; Mathney, Edward; Sanchez, Angela; Tinuoye, Elizabeth; Bateman, Brian; Eng, Kristen; Jiang, Ning; Ladha, Karim; Needleman, Joseph; Chen, Lee-Lynn; Lane, Rondall; Robinowitz, David; Ghushe, Neil; Irshad, Mariam; O'Connor, John; Patel, Samir; Takemoto, Steven; Wallace, Art; Mazzeffi, Michael; Rock, Peter; Wallace, Karin; Zhu, Xiaomao; Chua, Pandora; Mattera, Matthew; Sharar, Rebecca; Thilen, Stephan; Treggiari, Miriam; Morgan, Angela; Sofjan, Iwan; Subramaniam, Kathirvel; Avidan, Michael; Maybrier, Hannah; Muench, Maxwell; Wildes, Troy

2018-01-01

The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of

Prospective Observational Study on acute Appendicitis Worldwide (POSAW).

Science.gov (United States)

Sartelli, Massimo; Baiocchi, Gian L; Di Saverio, Salomone; Ferrara, Francesco; Labricciosa, Francesco M; Ansaloni, Luca; Coccolini, Federico; Vijayan, Deepak; Abbas, Ashraf; Abongwa, Hariscine K; Agboola, John; Ahmed, Adamu; Akhmeteli, Lali; Akkapulu, Nezih; Akkucuk, Seckin; Altintoprak, Fatih; Andreiev, Aurelia L; Anyfantakis, Dimitrios; Atanasov, Boiko; Bala, Miklosh; Balalis, Dimitrios; Baraket, Oussama; Bellanova, Giovanni; Beltran, Marcelo; Melo, Renato Bessa; Bini, Roberto; Bouliaris, Konstantinos; Brunelli, Daniele; Castillo, Adrian; Catani, Marco; Che Jusoh, Asri; Chichom-Mefire, Alain; Cocorullo, Gianfranco; Coimbra, Raul; Colak, Elif; Costa, Silvia; Das, Koray; Delibegovic, Samir; Demetrashvili, Zaza; Di Carlo, Isidoro; Kiseleva, Nadezda; El Zalabany, Tamer; Faro, Mario; Ferreira, Margarida; Fraga, Gustavo P; Gachabayov, Mahir; Ghnnam, Wagih M; Giménez Maurel, Teresa; Gkiokas, Georgios; Gomes, Carlos A; Griffiths, Ewen; Guner, Ali; Gupta, Sanjay; Hecker, Andreas; Hirano, Elcio S; Hodonou, Adrien; Hutan, Martin; Ioannidis, Orestis; Isik, Arda; Ivakhov, Georgy; Jain, Sumita; Jokubauskas, Mantas; Karamarkovic, Aleksandar; Kauhanen, Saila; Kaushik, Robin; Kavalakat, Alfie; Kenig, Jakub; Khokha, Vladimir; Khor, Desmond; Kim, Dennis; Kim, Jae I; Kong, Victor; Lasithiotakis, Konstantinos; Leão, Pedro; Leon, Miguel; Litvin, Andrey; Lohsiriwat, Varut; López-Tomassetti Fernandez, Eudaldo; Lostoridis, Eftychios; Maciel, James; Major, Piotr; Dimova, Ana; Manatakis, Dimitrios; Marinis, Athanasio; Martinez-Perez, Aleix; Marwah, Sanjay; McFarlane, Michael; Mesina, Cristian; Pędziwiatr, Michał; Michalopoulos, Nickos; Misiakos, Evangelos; Mohamedahmed, Ali; Moldovanu, Radu; Montori, Giulia; Mysore Narayana, Raghuveer; Negoi, Ionut; Nikolopoulos, Ioannis; Novelli, Giuseppe; Novikovs, Viktors; Olaoye, Iyiade; Omari, Abdelkarim; Ordoñez, Carlos A; Ouadii, Mouaqit; Ozkan, Zeynep; Pal, Ajay; Palini, Gian M; Partecke, Lars I; Pata, Francesco; Pędziwiatr, Michał; Pereira Júnior, Gerson A; Pintar, Tadeja; Pisarska, Magdalena; Ploneda-Valencia, Cesar F; Pouggouras, Konstantinos; Prabhu, Vinod; Ramakrishnapillai, Padmakumar; Regimbeau, Jean-Marc; Reitz, Marianne; Rios-Cruz, Daniel; Saar, Sten; Sakakushev, Boris; Seretis, Charalampos; Sazhin, Alexander; Shelat, Vishal; Skrovina, Matej; Smirnov, Dmitry; Spyropoulos, Charalampos; Strzałka, Marcin; Talving, Peep; Teixeira Gonsaga, Ricardo A; Theobald, George; Tomadze, Gia; Torba, Myftar; Tranà, Cristian; Ulrych, Jan; Uzunoğlu, Mustafa Y; Vasilescu, Alin; Occhionorelli, Savino; Venara, Aurélien; Vereczkei, Andras; Vettoretto, Nereo; Vlad, Nutu; Walędziak, Maciej; Yilmaz, Tonguç U; Yuan, Kuo-Ching; Yunfeng, Cui; Zilinskas, Justas; Grelpois, Gérard; Catena, Fausto

2018-01-01

Acute appendicitis (AA) is the most common surgical disease, and appendectomy is the treatment of choice in the majority of cases. A correct diagnosis is key for decreasing the negative appendectomy rate. The management can become difficult in case of complicated appendicitis. The aim of this study is to describe the worldwide clinical and diagnostic work-up and management of AA in surgical departments. This prospective multicenter observational study was performed in 116 worldwide surgical departments from 44 countries over a 6-month period (April 1, 2016-September 30, 2016). All consecutive patients admitted to surgical departments with a clinical diagnosis of AA were included in the study. A total of 4282 patients were enrolled in the POSAW study, 1928 (45%) women and 2354 (55%) men, with a median age of 29 years. Nine hundred and seven (21.2%) patients underwent an abdominal CT scan, 1856 (43.3%) patients an US, and 285 (6.7%) patients both CT scan and US. A total of 4097 (95.7%) patients underwent surgery; 1809 (42.2%) underwent open appendectomy and 2215 (51.7%) had laparoscopic appendectomy. One hundred eighty-five (4.3%) patients were managed conservatively. Major complications occurred in 199 patients (4.6%). The overall mortality rate was 0.28%. The results of the present study confirm the clinical value of imaging techniques and prognostic scores. Appendectomy remains the most effective treatment of acute appendicitis. Mortality rate is low.

The effectiveness of 2-implant overdentures - a pragmatic international multicentre study.

LENUS (Irish Health Repository)

Rashid, F

2011-03-01

The purpose of this multicentre observational study was to determine patient satisfaction with either conventional dentures or mandibular 2-implant overdentures in a \\'real world\\' setting. Two hundred and three edentulous patients (mean age 68·8 ± 10·4 years) were recruited at eight centres located in North America, South America and Europe. The patients were provided with new mandibular conventional dentures or implant overdentures supported by two implants and ball attachments. At baseline and at 6 months post-treatment, they rated their satisfaction with their mandibular prostheses on 100-mm visual analogue scale questionnaires. One hundred and two (50·2%) participants had valid baseline and 6-month satisfaction data. Although both groups reported improvements, the implant overdenture group reported significantly higher ratings of overall satisfaction, comfort, stability, ability to speak and ability to chew. These results suggest that edentulous patients who choose mandibular implant overdentures have significantly greater improvements in satisfaction, despite their relatively higher cost, than those who choose new conventional dentures.

Symptom prevalence in a cohort of 65 patients improved with the homoeopathic medicine Mangifera indica: A multicentric open observational clinical verification study

Directory of Open Access Journals (Sweden)

Raj K Manchanda

2017-01-01

Full Text Available Introduction: Clinical verification is an ongoing research program of the Council that verified many rare homoeopathic drugs. Aim: To clinically verify the ‘symptomatology’ of Mangifera indica by ascertaining the symptoms improved during verification. Materials and Methods: The study was a multicentric open label observational trial. Total 114 patients were enrolled after matching with the available symptom compendium and eligibility criteria in five centres of the Council. The medicine was prescribed in 6C, 30C, 200C and 1M potencies, as per need of the patient following the homoeopathic principles and protocol developed by the Council. The collected data were presented in terms of descriptive statistics. Prevalence of symptoms in the responding and non-responding population has been compared using Chi-square test. Results: Among the total 114 patients enrolled in the study, 77 patients who completed the follow up were analysed, as there were 37 drop out cases. The demographic analysis shows, male/female: 41/36, mean age 28.61 years. There was “clinical success” in 65 cases (84.41% and failures in 12 cases (15.59%, judged subjectively by the physicians. A minimum of two prescriptions were considered for pick listing each symptom as a rule of thumb. Conclusions: Total 16 CCRH proving symptoms were verified, 4 symptoms from other literatures were also verified. 51 new clinical symptoms/symptom components were identified. Further replication and estimation of likelihood ratio in general practice setting is crucial for confirmation and inclusion of such symptoms in homoeopathic literatures.

Predictive modelling for swallowing dysfunction after primary (chemo)radiation: results of a prospective observational study.

Science.gov (United States)

Christianen, Miranda E M C; Schilstra, Cornelis; Beetz, Ivo; Muijs, Christina T; Chouvalova, Olga; Burlage, Fred R; Doornaert, Patricia; Koken, Phil W; Leemans, C René; Rinkel, Rico N P M; de Bruijn, Marieke J; de Bock, G H; Roodenburg, Jan L N; van der Laan, Bernard F A M; Slotman, Ben J; Verdonck-de Leeuw, Irma M; Bijl, Hendrik P; Langendijk, Johannes A

2012-10-01

The purpose of this large multicentre prospective cohort study was to identify which dose volume histogram parameters and pre-treatment factors are most important to predict physician-rated and patient-rated radiation-induced swallowing dysfunction (RISD) in order to develop predictive models for RISD after curative (chemo) radiotherapy ((CH) RT). The study population consisted of 354 consecutive head and neck cancer patients treated with (CH) RT. The primary endpoint was grade 2 or more swallowing dysfunction according to the RTOG/EORTC late radiation morbidity scoring criteria at 6 months after (CH) RT. The secondary endpoints were patient-rated swallowing complaints as assessed with the EORTC QLQ-H&N35 questionnaire. To select the most predictive variables a multivariate logistic regression analysis with bootstrapping was used. At 6 months after (CH) RT the bootstrapping procedure revealed that a model based on the mean dose to the superior pharyngeal constrictor muscle (PCM) and mean dose to the supraglottic larynx was most predictive. For the secondary endpoints different predictive models were found: for problems with swallowing liquids the most predictive factors were the mean dose to the supraglottic larynx and radiation technique (3D-CRT versus IMRT). For problems with swallowing soft food the mean dose to the middle PCM, age (18-65 versus >65 years), tumour site (naso/oropharynx versus other sites) and radiation technique (3D-CRT versus IMRT) were the most predictive factors. For problems with swallowing solid food the most predictive factors were the mean dose to the superior PCM, the mean dose to the supraglottic larynx and age (18-65 versus >65 years). And for choking when swallowing the V60 of the oesophageal inlet muscle and the mean dose to the supraglottic larynx were the most predictive factors. Physician-rated and patient-rated RISD in head and neck cancer patients treated with (CH) RT cannot be predicted with univariate relationships between the

Exoplanet Biosignatures: Observational Prospects

Science.gov (United States)

Angerhausen, Daniel; Deitrick, Russell; Domagal-Goldman, Shawn; Grenfell, John Lee; Hori, Yasunori; Kane, Stephen R.; Pallé, Enric; Rauer, Heike; Siegler, Nicholas; Stapelfeldt, Karl; Stevenson, Kevin B.

2018-01-01

Abstract Exoplanet hunting efforts have revealed the prevalence of exotic worlds with diverse properties, including Earth-sized bodies, which has fueled our endeavor to search for life beyond the Solar System. Accumulating experiences in astrophysical, chemical, and climatological characterization of uninhabitable planets are paving the way to characterization of potentially habitable planets. In this paper, we review our possibilities and limitations in characterizing temperate terrestrial planets with future observational capabilities through the 2030s and beyond, as a basis of a broad range of discussions on how to advance “astrobiology” with exoplanets. We discuss the observability of not only the proposed biosignature candidates themselves but also of more general planetary properties that provide circumstantial evidence, since the evaluation of any biosignature candidate relies on its context. Characterization of temperate Earth-sized planets in the coming years will focus on those around nearby late-type stars. The James Webb Space Telescope (JWST) and later 30-meter-class ground-based telescopes will empower their chemical investigations. Spectroscopic studies of potentially habitable planets around solar-type stars will likely require a designated spacecraft mission for direct imaging, leveraging technologies that are already being developed and tested as part of the Wide Field InfraRed Survey Telescope (WFIRST) mission. Successful initial characterization of a few nearby targets will be an important touchstone toward a more detailed scrutiny and a larger survey that are envisioned beyond 2030. The broad outlook this paper presents may help develop new observational techniques to detect relevant features as well as frameworks to diagnose planets based on the observables. Key Words: Exoplanets—Biosignatures—Characterization—Planetary atmospheres—Planetary surfaces. Astrobiology 18, 739–778. PMID:29938537

Prospects for SODART observations of nearby clusters of galaxies

DEFF Research Database (Denmark)

Pedersen, Kenneth; Westergaard, Niels Jørgen Stenfeldt

1998-01-01

Using the current best understanding of the SODART mirror system, the Bragg panel and of the LEPC/HEPC responses [1] we have studied the feasibility and prospects for SODART studies of nearby clusters of galaxies. From simulated HEPC data of the cluster Abell 2256, we demonstrate that SODART...

Is laparoscopic surgery really effective for the treatment of colon and rectal cancer in very elderly over 80 years old? A prospective multicentric case-control assessment.

Science.gov (United States)

Roscio, Francesco; Boni, Luigi; Clerici, Federico; Frattini, Paolo; Cassinotti, Elisa; Scandroglio, Ildo

2016-10-01

To evaluate the effectiveness of laparoscopic surgery (LCS) for colon and rectal cancer in the very elderly over 80 years old. We performed a prospective multicentric analysis comparing patients over 80 years (Group A) and patients between 60 and 69 years (Group B) undergoing LCS for cancer from January 2008 to December 2013. Colon and rectal cancers were analyzed separately. Comorbidity and complications were classified using the Charlson comorbidity index (CCI) and the Clavien-Dindo system, respectively. Oncological parameters included tumor-free margins, number of lymph nodes harvested and circumferential resection margin. Group A included 96 and 33 patients, and Group B 220 and 82 for colon and rectal cancers, respectively. Groups were similar except for ASA score and CCI, as expected. There was no significant difference in operative time [colon; rectum] (180[IQR 150-200] vs 180[150-210] min; NS-180[160-210] vs 180[165-240] min; NS), estimated blood loss (50[25-75] vs 50[25-120] mL; NS-50[0-150] vs 50[25-108.7] mL; NS) and conversion rate (2.1 vs 2.7 %; NS-3.0 vs 2.4 %; NS). Timing of first stool (3[2-3.25] vs 3[2-5] dd; NS-3[2-4] vs 3[2-5] dd; NS), length of stay (7[6-8] vs 7[6-8] dd; NS-8[8-9] vs 8[7-9] dd; NS) and readmission rate (1.0 vs 0.45 %; NS-6.1 vs 1.2 %; NS) were similar. Tumor-free margins were appropriate, and positivity of CRM is poor (6.1 vs 4.9; NS). We did not record significant differences in complications rate (47.9 vs 43.6 %; NS-63.6 vs 52.4 %; NS). Laparoscopic surgery is effective for the treatment of colorectal cancer even in the very elderly. Age is not a risk factor or a limitation for LCS.

Prophylactic antibiotic regimens in tumour surgery (PARITY) : a pilot multicentre randomised controlled trial

NARCIS (Netherlands)

Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.

2015-01-01

Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

NARCIS (Netherlands)

Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

2015-01-01

OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

NARCIS (Netherlands)

Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Rengerink, Katrien Oude; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

2015-01-01

Objective To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an

Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

NARCIS (Netherlands)

Freeman, L.M.; Bloemenkamp, K.W.; Franssen, M.T.; Papatsonis, D.N.; Hajenius, P.J.; Hollmann, M.W.; Woiski, M.D.; Porath, M.; Berg, H.J. van den; Beek, E. van; Borchert, O.W.; Schuitemaker, N.; Sikkema, J.M.; Kuipers, A.H.; Logtenberg, S.L.; Salm, P.C. van der; Oude Rengerink, K.; Lopriore, E.; Akker-van Marle, M.E. van den; Cessie, S. le; Lith, J.M. van; Struys, M.M.; Mol, B.W.; Dahan, A; Middeldorp, J.M.

2015-01-01

OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

Design of Lamifuse: a randomised, multi-centre controlled trial comparing laminectomy without or with dorsal fusion for cervical myeloradiculopathy

Directory of Open Access Journals (Sweden)

Grotenhuis J André

2007-11-01

Full Text Available Abstract Background laminectomy is a valuable surgical treatment for some patients with a cervical radiculomyelopathy due to cervical spinal stenosis. More recently attention has been given to motion of the spinal cord over spondylotic spurs as a cause of myelopathic changes. Immobilisation by fusion could have a positive effect on the recovery of myelopathic signs or changes. This has never been investigated in a prospective, randomised trial. Lamifuse is an acronyme for laminectomy and fusion. Methods/Design Lamifuse is a multicentre, randomised controlled trial comparing laminectomy with and without fusion in patients with a symptomatic cervical canal stenosis. The study population will be enrolled from patients that are 60 years or older with myelopathic signs and/or symptoms due to a cervical canal stenosis. A kyphotis shape of the cervical spine is an exclusion criterium. Each treatment arm needs 30 patients. Discussion This study will contribute to the discussion whether additional fusion after a cervical laminectomy results in a better clinical outcome. ISRCT number ISRCTN72800446

Iohexol in investigations of the spinal canal. Multicentre study

International Nuclear Information System (INIS)

Bories, J.

1988-01-01

The author presents the results of a multicentric study of Iohexol in investigation of the spinal canal undertaken at the request of Winthrop Laboratories in 32 Radiological departments. The study involved 329 adults of both sexes. It confirmed the excellent quality of results obtained with this preparation in the literature and its excellent tolerance. On the basis of these results Iohexol may be considered to be definitely one of the best currently available preparations for investigation of the spinal canal [fr

Low sodium diet and pregnancy-induced hypertension: a multi-centre randomised controlled trial

NARCIS (Netherlands)

Knuist, M.; Bonsel, G. J.; Zondervan, H. A.; Treffers, P. E.

1998-01-01

To examine the effectiveness of the standard policy in the Netherlands to prescribe a sodium restricted diet to prevent or to treat mild pregnancy-induced hypertension. Multi-centre randomised controlled trial between April 1992 and April 1994. Seven practices of independent midwives and one

A multicentre study of 513 Danish patients with systemic lupus erythematosus. II. Disease mortality and clinical factors of prognostic value

DEFF Research Database (Denmark)

Jacobsen, S; Petersen, J; Ullman, S

1998-01-01

influence on survival related to mortality caused by infections. Diffuse central nervous system disease and myocarditis were related to increased SLE-related mortality, whereas photosensitivity predicted a decreased mortality. Non-fatal infections and thrombotic events predicted a decreased overall survival......In this Danish multicentre study, predictive clinical factors of mortality and survival were calculated for 513 patients with systemic lupus erythematosus (SLE), 122 of whom died within a mean observation period of 8.2 years equalling a mortality rate of 2.9% per year. Survival rates were 97%, 91...

Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial

DEFF Research Database (Denmark)

Nyboeandersen, A.; Humaidan, P.; Fried, G.

2008-01-01

BACKGROUND: The purpose of this multicentre, multinational trial was to study whether rLH supplementation to recombinant FSH (rFSH) during the late follicular phase increased pregnancy rates. METHODS: After down-regulation with nafarelin, 526 women were randomized on Day 1 of stimulation to use...... either rFSH (Gonal-F) alone (n = 261) or to continue after Day 6 of stimulation with both rFSH (Gonal-F) and rLH (Luveris) (n = 265) from Day 6. The starting dose of rFSH was 150-225 IU/day according to age below or above 35 years. RESULTS: Ongoing pregnancy rate at week 10-12 was 28.7% after rFSH alone...... and 27.2% after rFSH + rLH. This showed no evidence of a difference. Administration of rLH significantly (Prates in patients with low LH levels (

Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial

DEFF Research Database (Denmark)

Nyboeandersen, A; Al Humaidan, Peter Samir Heskjær; Fried, G

2008-01-01

BACKGROUND: The purpose of this multicentre, multinational trial was to study whether rLH supplementation to recombinant FSH (rFSH) during the late follicular phase increased pregnancy rates. METHODS: After down-regulation with nafarelin, 526 women were randomized on Day 1 of stimulation to use...... either rFSH (Gonal-F) alone (n = 261) or to continue after Day 6 of stimulation with both rFSH (Gonal-F) and rLH (Luveris) (n = 265) from Day 6. The starting dose of rFSH was 150-225 IU/day according to age below or above 35 years. RESULTS: Ongoing pregnancy rate at week 10-12 was 28.7% after rFSH alone...... and 27.2% after rFSH + rLH. This showed no evidence of a difference. Administration of rLH significantly (PLH. Ongoing pregnancy rates in patients with low LH levels (

A teaching intervention in a contouring dummy run improved target volume delineation in locally advanced non-small cell lung cancer: Reducing the interobserver variability in multicentre clinical studies.

Science.gov (United States)

Schimek-Jasch, Tanja; Troost, Esther G C; Rücker, Gerta; Prokic, Vesna; Avlar, Melanie; Duncker-Rohr, Viola; Mix, Michael; Doll, Christian; Grosu, Anca-Ligia; Nestle, Ursula

2015-06-01

Interobserver variability in the definition of target volumes (TVs) is a well-known confounding factor in (multicentre) clinical studies employing radiotherapy. Therefore, detailed contouring guidelines are provided in the prospective randomised multicentre PET-Plan (NCT00697333) clinical trial protocol. This trial compares strictly FDG-PET-based TV delineation with conventional TV delineation in patients with locally advanced non-small cell lung cancer (NSCLC). Despite detailed contouring guidelines, their interpretation by different radiation oncologists can vary considerably, leading to undesirable discrepancies in TV delineation. Considering this, as part of the PET-Plan study quality assurance (QA), a contouring dummy run (DR) consisting of two phases was performed to analyse the interobserver variability before and after teaching. In the first phase of the DR (DR1), radiation oncologists from 14 study centres were asked to delineate TVs as defined by the study protocol (gross TV, GTV; and two clinical TVs, CTV-A and CTV-B) in a test patient. A teaching session was held at a study group meeting, including a discussion of the results focussing on discordances in comparison to the per-protocol solution. Subsequently, the second phase of the DR (DR2) was performed in order to evaluate the impact of teaching. Teaching after DR1 resulted in a reduction of absolute TVs in DR2, as well as in better concordance of TVs. The Overall Kappa(κ) indices increased from 0.63 to 0.71 (GTV), 0.60 to 0.65 (CTV-A) and from 0.59 to 0.63 (CTV-B), demonstrating improvements in overall interobserver agreement. Contouring DRs and study group meetings as part of QA in multicentre clinical trials help to identify misinterpretations of per-protocol TV delineation. Teaching the correct interpretation of protocol contouring guidelines leads to a reduction in interobserver variability and to more consistent contouring, which should consequently improve the validity of the overall study

A teaching intervention in a contouring dummy run improved target volume delineation in locally advanced non-small cell lung cancer. Reducing the interobserver variability in multicentre clinical studies

International Nuclear Information System (INIS)

Schimek-Jasch, Tanja; Prokic, Vesna; Doll, Christian; Grosu, Anca-Ligia; Nestle, Ursula; Troost, Esther G.C.; Ruecker, Gerta; Avlar, Melanie; Duncker-Rohr, Viola; Mix, Michael

2015-01-01

Interobserver variability in the definition of target volumes (TVs) is a well-known confounding factor in (multicentre) clinical studies employing radiotherapy. Therefore, detailed contouring guidelines are provided in the prospective randomised multicentre PET-Plan (NCT00697333) clinical trial protocol. This trial compares strictly FDG-PET-based TV delineation with conventional TV delineation in patients with locally advanced non-small cell lung cancer (NSCLC). Despite detailed contouring guidelines, their interpretation by different radiation oncologists can vary considerably, leading to undesirable discrepancies in TV delineation. Considering this, as part of the PET-Plan study quality assurance (QA), a contouring dummy run (DR) consisting of two phases was performed to analyse the interobserver variability before and after teaching. In the first phase of the DR (DR1), radiation oncologists from 14 study centres were asked to delineate TVs as defined by the study protocol (gross TV, GTV; and two clinical TVs, CTV-A and CTV-B) in a test patient. A teaching session was held at a study group meeting, including a discussion of the results focussing on discordances in comparison to the per-protocol solution. Subsequently, the second phase of the DR (DR2) was performed in order to evaluate the impact of teaching. Teaching after DR1 resulted in a reduction of absolute TVs in DR2, as well as in better concordance of TVs. The Overall Kappa(κ) indices increased from 0.63 to 0.71 (GTV), 0.60 to 0.65 (CTV-A) and from 0.59 to 0.63 (CTV-B), demonstrating improvements in overall interobserver agreement. Contouring DRs and study group meetings as part of QA in multicentre clinical trials help to identify misinterpretations of per-protocol TV delineation. Teaching the correct interpretation of protocol contouring guidelines leads to a reduction in interobserver variability and to more consistent contouring, which should consequently improve the validity of the overall study

Metabolic Abnormalities Detected in Phase II Evaluation of Doxycycline in Dogs with Multicentric B-Cell Lymphoma.

Science.gov (United States)

Hume, Kelly R; Sylvester, Skylar R; Borlle, Lucia; Balkman, Cheryl E; McCleary-Wheeler, Angela L; Pulvino, Mary; Casulo, Carla; Zhao, Jiyong

2018-01-01

Doxycycline has antiproliferative effects in human lymphoma cells and in murine xenografts. We hypothesized that doxycycline would decrease canine lymphoma cell viability and prospectively evaluated its clinical tolerability in client-owned dogs with spontaneous, nodal, multicentric, substage a, B-cell lymphoma, not previously treated with chemotherapy. Treatment duration ranged from 1 to 8 weeks (median and mean, 3 weeks). Dogs were treated with either 10 ( n  = 6) or 7.5 ( n  = 7) mg/kg by mouth twice daily. One dog had a stable disease for 6 weeks. No complete or partial tumor responses were observed. Five dogs developed grade 3 and/or 4 metabolic abnormalities suggestive of hepatopathy with elevations in bilirubin, ALT, ALP, and/or AST. To evaluate the absorption of oral doxycycline in our study population, serum concentrations in 10 treated dogs were determined using liquid chromatography tandem mass spectrometry. Serum levels were variable and ranged from 3.6 to 16.6 µg/ml (median, 7.6 µg/ml; mean, 8.8 µg/ml). To evaluate the effect of doxycycline on canine lymphoma cell viability in vitro , trypan blue exclusion assay was performed on canine B-cell lymphoma cell lines (17-71 and CLBL) and primary B-cell lymphoma cells from the nodal tissue of four dogs. A doxycycline concentration of 6 µg/ml decreased canine lymphoma cell viability by 80%, compared to matched, untreated, control cells (mixed model analysis, p  canine lymphoma, combination therapy may be worthwhile if future research determines that doxycycline can alter cell survival pathways in canine lymphoma cells. Due to the potential for metabolic abnormalities, close monitoring is recommended with the use of this drug in tumor-bearing dogs. Additional research is needed to assess the tolerability of chronic doxycycline therapy.

Reduced risk of surgical site infections through surveillance in a network

NARCIS (Netherlands)

Geubbels, Eveline L. P. E.; Nagelkerke, Nico J. D.; Mintjes-de Groot, A. Joke; Vandenbroucke-Grauls, Christina M. J. E.; Grobbee, Diederick E.; de Boer, Annette S.

2006-01-01

OBJECTIVE: To estimate the effect of multicentre surveillance for nosocomial infections on patients' risk of surgical site infection (SSI). DESIGN: Prospective multi-centre cohort study, from January 1996 to December 2000. SETTING: Acute care hospitals in The Netherlands. STUDY PARTICIPANTS: All 50

Ethics and observational studies in medical research: various rules in a common framework

Science.gov (United States)

Claudot, Frédérique; Alla, François; Fresson, Jeanne; Calvez, Thierry; Coudane, Henry; Bonaïti-Pellié, Catherine

2009-01-01

Background Research ethics have become universal in their principles through international agreements. The standardization of regulations facilitates the internationalization of research concerning drugs. However, in so-called observational studies (i.e. from data collected retrospectively or prospectively, obtained without any additional therapy or monitoring procedure), the modalities used for applying the main principles vary from one country to the other. This situation may entail problems for the conduct of multi-centric international studies, as well as for the publication of results if the authors and editors come from countries governed by different regulations. In particular, several French observational studies were rejected or retracted by United States peer reviewed journals, because their protocols have not been submitted to an Institutional Review Board/Independent Ethics Committee (IRB/IEC). Methods national legislation case analysis Results In accordance with European regulation, French observational studies from data obtained without any additional therapy or monitoring procedure, do not need the approval of an IRB/IEC. Nevertheless, these researches are neither exempt from scientific opinion nor from ethical and legal authorization. Conclusion We wish to demonstrate through the study of this example that different bodies of law can provide equivalent levels of protection that respect the same ethical principles. Our purpose in writing this paper was to encourage public bodies, scientific journals, and researchers to gain a better understanding of the various sets of specific national regulations and to speak a common language. PMID:19336436

A new Gauss quadrature for multicentre integrals over STOs in the Gaussian integral transform approach

International Nuclear Information System (INIS)

Bouferguene, Ahmed

2005-01-01

When computing multicentre integrals over Slater-type orbitals (STOs) by means of the Shavitt and Karplus Gaussian integral transforms (Shavitt and Karplus 1962 J. Chem. Phys. 36 550), one usually ends up with a multiple integral of the form ∫ 0 1 du ∫ 0 1 dv ...∫ 0 ∞ dz F(u, v, ..., z) (Shavitt and Karplus 1965 J. Chem. Phys. 43 398) in which all the integrals are inter-related. The most widely used approach for computing such an integral is to apply a product of Gauss-Legendre quadratures for the integrals over [0, 1] while the semi-infinite term is evaluated by a special procedure. Although numerous approaches have been developed to accurately perform the integration over [0, ∞) efficiently, it is the aim of this work to add a new tool that could be of some benefit in carrying out the hard task of multicentre integrals over STOs. The new approach relies on a special Gauss quadrature referred to as Gauss-Bessel to accurately evaluate the semi-infinite integral of interest. In this work, emphasis is put on accuracy rather than efficiency since its aim is essentially to bring a proof of concept showing that Gauss-Bessel quadrature can successfully be applied in the context of multicentre integrals over STOs. The obtained accuracy is comparable to that obtained with other methods available in the literature

PREVAIL TRANSAPICAL: multicentre trial of transcatheter aortic valve implantation using the newly designed bioprosthesis (SAPIEN-XT) and delivery system (ASCENDRA-II).

Science.gov (United States)

Walther, Thomas; Thielmann, Matthias; Kempfert, Joerg; Schroefel, Holger; Wimmer-Greinecker, Gerhard; Treede, Hendrik; Wahlers, Thorsten; Wendler, Olaf

2012-08-01

Transapical (TA) aortic valve implantation (AVI) has evolved as an alternative procedure for high-risk patients. We evaluated the second-generation SAPIEN XT™ prosthesis in a prospective multicentre clinical trial. A total of 150 patients (age: 81.6 ± 5.8 years; 40.7% female) were included. Prosthetic valves (diameter: 23 mm (n = 36), 26 mm (n = 57) and 29 mm (n = 57)) were implanted. The ASCENDRA-II™ modified delivery system was used in the smaller sizes. Mean logistic EuroSCORE was 24.3 ± 7.0%, and mean STS score 7.5 ± 4.4%. All patients gave written informed consent. Off-pump AVI was performed using femoral arterial and venous access wires as a safety net. All but two patients received TA-AVI, as planned. The 29-mm valve showed similar function as the values of two other diameters did. Three patients (2%) required temporary cardiopulmonary bypass support. Postoperative complications included renal failure requiring long-term dialysis in four, bleeding requiring rethoracotomy in four, respiratory complication requiring reintubation in eight and sepsis in four patients, respectively. Thirty-day mortality was 13 (8.7%) for the total cohort and 2/57 (3.5%) for patients receiving the 29-mm valve, respectively. Echocardiography at discharge showed none or trivial aortic incompetence (AI) in 71% and mild-AI in 22% of the patients. Post-implantation AI was predominantly paravalvular and ≥ 2+ in 7% of patients. One patient required reoperation for AI within 30 days. The PREVAIL TA multicentre trial demonstrates good functionality and good outcomes for TA-AVI, using the SAPIEN XT™ prosthesis and its second-generation ASCENDRA-II™ delivery system, as well successful introduction of the 29-mm SAPIEN XT™ valve for the benefit of high-risk elderly patients.

Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

NARCIS (Netherlands)

Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

2015-01-01

To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Multicentre randomised controlled equivalence trial. 15 hospitals in the Netherlands. Women with an intermediate to high obstetric risk with an

Evaluation of the preliminary auditory profile test battery in an international multi-centre study

NARCIS (Netherlands)

van Esch, T.E.M.; Kollmeier, B.; Vormann, M.; Lijzenga, J.; Houtgast, T.; Hallgren, M.; Larsby, B.; Athalye, S.P.; Lutman, M.E.; Dreschler, W.A.

2013-01-01

Objective: This paper describes the composition and international multi-centre evaluation of a battery of tests termed the preliminary auditory profile. It includes measures of loudness perception, listening effort, speech perception, spectral and temporal resolution, spatial hearing, self-reported

The efficacy and safety of enoxaparin versus unfractionated heparin for prevention of deep vein thrombosis in elective cancer surgery. A double blind randomized multicentre trail with venographic assesment

DEFF Research Database (Denmark)

Bergkvist, A; Eldor, A; Thorlacius-Ussing, O.

1997-01-01

BACKGROUND: Surgery for malignant disease carries a high risk of deep vein thrombosis. The aim of this study was to evaluate the prophylactic effect of a low molecular weight heparin, enoxaparin, 40 mg once daily, beginning 2 h before surgery, compared with that of unfractionated low-dose heparin...... three times daily. METHODS: Patients included were over 40 years of age and undergoing planned elective curative abdominal or pelvic surgery for cancer. The study was designed as a prospective double-blind randomized multicentre trial with participating departments from ten countries. Primary outcome...... severe thrombocytopenia. There were no differences in mortality at either 30 days or 3 months. CONCLUSION: Enoxaparin, 40 mg once daily, is as safe and effective as unfractionated heparin three times daily in preventing venous thromboembolism in patients undergoing major elective surgery for abdominal...

Fast neutrons in the treatment of head and neck cancers: the results of a multi-centre randomly controlled trial

International Nuclear Information System (INIS)

Duncan, W.; Arnott, S.J.; Orr, J.A.; Kerr, G.R.; Schmitt, G.

1984-01-01

The results are presented of a multi-centre randomly controlled trial of fast neutron irradiation and mega-voltage X-rays in the treatment of patients with locally advanced squamous cell carcinoma of the head and neck region. No significant difference was observed in local tumour control rates. Salvage surgery was performed in a similar number of patients in the two groups. Late morbidity was also similar in the two treatment groups. Patients in a subgroup with cancer of the larynx treated by photons had a significantly better survival than those in the neutron treated group. (Auth.)

First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study

NARCIS (Netherlands)

Doizi, Steeve; Kamphuis, Guido; Giusti, Guido; Andreassen, Kim Hovgaard; Knoll, Thomas; Osther, Palle Jörn; Scoffone, Cesare; Pérez-Fentes, Daniel; Proietti, Silvia; Wiseman, Oliver; de la Rosette, Jean; Traxer, Olivier

2017-01-01

We evaluated a new digital single-use flexible ureteroscope, LithoVue™ with respect to deflection, image quality and maneuverability. A prospective cohort study was conducted in eight tertiary reference centers in Europe in December 2015 and January 2016. All consecutive patients included underwent

Quality of life before and after TVT, a prospective multicentre cohort study, results from the Netherlands TVT database

NARCIS (Netherlands)

Koops, SES; Bisseling, TM; Heintz, APM; Vervest, HAM

Objective To asses the long term outcome of tension-free vaginal tape procedure in women with isolated stress urinary incontinence (SUI). Design Prospective cohort study. Setting Twenty-eight teaching hospitals and 13 local hospitals, with 54 gynaecologists and urologists performing the surgery.

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

Science.gov (United States)

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits

A Prospective Observational Survey on the Long-Term Effect of LDL Apheresis on Drug-Resistant Nephrotic Syndrome

Directory of Open Access Journals (Sweden)

Eri Muso

2015-08-01

Full Text Available Background/Aims: LDL apheresis (LDL-A is used for drug-resistant nephrotic syndrome (NS as an alternative therapy to induce remission by improvement of hyperlipidemia. Several clinical studies have suggested the efficacy of LDL-A for refractory NS, but the level of evidence remains insufficient. A multicenter prospective study, POLARIS (Prospective Observational Survey on the Long-Term Effects of LDL Apheresis on Drug-Resistant Nephrotic Syndrome, was conducted to evaluate its clinical efficacy with high-level evidence. Methods: Patients with NS who showed resistance to primary medication for at least 4 weeks were prospectively recruited to the study and treated with LDL-A. The long-term outcome was evaluated based on the rate of remission of NS 2 years after treatment. Factors affecting the outcome were also examined. Results: A total of 58 refractory NS patients from 40 facilities were recruited and enrolled as subjects of the POLARIS study. Of the 44 subjects followed for 2 years, 21 (47.7% showed remission of NS based on a urinary protein (UP level Conclusions: Almost half of the cases of drug-resistant NS showed remission 2 years after LDL-A. Improvement of nephrotic parameters at termination of the LDL-A treatment was a predictor of a favorable outcome.

Current management of intracerebral haemorrhage in China: a national, multi-centre, hospital register study

Directory of Open Access Journals (Sweden)

Heeley Emma L

2011-01-01

Full Text Available Abstract Background We aimed to examine current practice of the management and secondary prevention of intracerebral haemorrhage (ICH in China where the disease is more common than in Western populations. Methods Data on baseline characteristics, management in-hospital and post-stroke, and outcome of ICH patients are from the ChinaQUEST (QUality Evaluation of Stroke Care and Treatment study, a multi-centre, prospective, 62 hospital registry in China during 2006-07. Results Nearly all ICH patients (n = 1572 received an intravenous haemodiluting agent such as mannitol (96% or a neuroprotectant (72%, and there was high use of intravenous traditional Chinese medicine (TCM (42%. Neurosurgery was undertaken in 137 (9% patients; being overweight, having a low Glasgow Coma Scale (GCS score on admission, and Total Anterior Circulation Syndrome (TACS clinical pattern on admission, were the only baseline factors associated with this intervention in multivariate analyses. Neurosurgery was associated with nearly three times higher risk of death/disability at 3 months post-stroke (odd ratio [OR] 2.60, p Conclusions The management of ICH in China is characterised by high rates of use of intravenous haemodiluting agents, neuroprotectants, and TCM, and of antihypertensives for secondary prevention. The controversial efficacy of these therapies, coupled with the current lack of treatments of proven benefit, is a call for action for more outcomes based research in ICH.

Ovarian response to 150 µg corifollitropin alfa in a GnRH-antagonist multiple-dose protocol: a prospective cohort study.

Science.gov (United States)

Lerman, Tamara; Depenbusch, Marion; Schultze-Mosgau, Askan; von Otte, Soeren; Scheinhardt, Markus; Koenig, Inke; Kamischke, Axel; Macek, Milan; Schwennicke, Arne; Segerer, Sabine; Griesinger, Georg

2017-05-01

The incidence of low (18 oocytes) ovarian response to 150 µg corifollitropin alfa in relation to anti-Müllerian hormone (AMH) and other biomarkers was studied in a multi-centre (n = 5), multi-national, prospective, investigator-initiated, observational cohort study. Infertile women (n = 212), body weight >60 kg, underwent controlled ovarian stimulation in a gonadotrophin-releasing hormone-antagonist multiple-dose protocol. Demographic, sonographic and endocrine parameters were prospectively assessed on cycle day 2 or 3 of a spontaneous menstruation before the administration of 150 µg corifollitropin alfa. Serum AMH showed the best correlation with the number of oocytes obtained among all predictor variables. In receiver-operating characteristic analysis, AMH at a threshold of 0.91 ng/ml showed a sensitivity of 82.4%, specificity of 82.4%, positive predictive value 52.9%and negative predictive value 95.1% for predicting low response (area under the curve [AUC], 95% CI; P-value: 0.853, 0.769-0.936; <0.0001). For predicting high response, the optimal threshold for AMH was 2.58 ng/ml, relating to a sensitivity of 80.0%, specificity 82.1%, positive predictive value 42.5% and negative predictive value 96.1% (AUC, 95% CI; P-value: 0.871, 0.787-0.955; <0.0001). In conclusion, patients with serum AMH concentrations between approximately 0.9 and 2.6 ng/ml were unlikely to show extremes of response. Copyright © 2017. Published by Elsevier Ltd.

Malnutrition in Hospitalised Older Adults: A Multicentre Observational Study of Prevalence, Associations and Outcomes.

Science.gov (United States)

O'Shea, E; Trawley, S; Manning, E; Barrett, A; Browne, V; Timmons, S

2017-01-01

Malnutrition is common in older adults and is associated with high costs and adverse outcomes. The prevalence, predictors and outcomes of malnutrition on admission to hospital are not clear for this population. Prospective Cohort Study. Six hospital sites (five public, one private). In total, 606 older adults aged 70+ were included. All elective and acute admissions to any speciality were eligible. Day-case admissions and those moribund on admission were excluded. Socio-demographic and clinical data, including nutritional status (Mini-Nutritional Assessment - short form), was collected within 36 hours of admission. Outcome data was collected prospectively on length of stay, in-hospital mortality and new institutionalisation. The mean age was 79.7; 51% were female; 29% were elective admissions; 67% were admitted to a medical specialty. Nutrition scores were available for 602/606; 37% had a 'normal' status, 45% were 'at-risk', and 18% were 'malnourished'. Malnutrition was more common in females, acute admissions, older patients and those who were widowed/ separated. Dementia, functional dependency, comorbidity and frailty independently predicted a) malnutrition and b) being at-risk of malnutrition, compared to normal status (p Malnutrition was associated with outcomes including an increased length of stay (p < .001), new institutionalisation (p =<0.001) and in-hospital mortality (p < .001). These findings support the prioritisation of nutritional screening in clinical practice and public health policy, for all patients ≥70 on admission to hospital, and in particular for people with dementia, increased functional dependency and/or multi-morbidity, and those who are frail.

Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study.

Science.gov (United States)

Mackenzie, Isla S; Ford, Ian; Walker, Andrew; Hawkey, Chris; Begg, Alan; Avery, Anthony; Taggar, Jaspal; Wei, Li; Struthers, Allan D; MacDonald, Thomas M

2016-09-08

Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. 32017426, pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

DEFF Research Database (Denmark)

Kasch, Helge; Kongsted, Alice; Qerama, Erisela

2013-01-01

within 72 h, examination prior to 10 days postinjury, capable of written/spoken Danish, without other injuries/fractures, pre-existing significant somatic/psychiatric disorder, drug/alcohol abuse and previous significant pain/headache). 688 (438 women and 250 men) participants were interviewed......OBJECTIVES: An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. DESIGN: The design was an observational prospective study of risk factors embedded in a randomised controlled study. SETTING: Acute whiplash...... and number of sick-listing days were related (Kruskal-Wallis, p

Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study

International Nuclear Information System (INIS)

Martín-Richard, Marta; Sala, Maria Angeles; Pericay, Carlos; Rivera, Fernando; Sastre, Javier; Segura, Ángel; Quindós, Maria; Maisonobe, Pascal; Massutí, Bartomeu; Pineda, Eva; Alonso, Vicente; Marmol, Maribel; Castellano, Daniel; Fonseca, Emilio; Galán, Antonio; Llanos, Marta

2013-01-01

Somatostatin analogues (SSAs) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours (NETs). This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs. This was a multicentre, open-label, phase II trial conducted in 17 Spanish specialist centres. Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, tumour biomarkers, symptom control, quality of life (QoL), and safety. Radiographic imaging was assessed by a blinded central radiologist. Of 30 patients included in the efficacy and safety analyses, 40% had midgut tumours and 27% pancreatic tumours; 63% of tumours were functioning. Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%). No deterioration in QoL was observed. Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe. Lanreotide Autogel provided effective tumour stabilisation and PFS >12 months in patients with progressive NETs ineligible for surgery or chemotherapy, with a safety profile consistent with the pharmacology of the class. ClinicalTrials.gov Identifier http://clinicaltrials.gov/show/NCT00326469; EU Clinical Trial Register EudraCT no 2004-002871-18

Single-Port Transumbilical Laparoscopic Appendectomy: A Preliminary Multicentric Comparative Study in 87 Patients with Acute Appendicitis

Directory of Open Access Journals (Sweden)

Ramon Vilallonga

2012-01-01

Full Text Available Introduction. Laparoscopic appendectomy (LA has been performed in many approaches such as open, laparoscopic and recently Single Port Access (SPAA. In order to elucidate its potential advantages, we compared the two laparoscopic approaches. Methods. 87 patients were included in a multicentric study for suspected appendicitis in order to perform (SPAA appendectomy or laparoscopic appendectomy (LA. All outcomes, including blood loss, operative time, complications, and length of stay and pain were recorded prospectively. Results. There were 46 patients in the SPAA group and 41 in the LAG with a mean operative time of 40,4 minutes in the SPAA group and 35,0 minutes in the LA group. Only one patient was converted to an open approach. We described only 2 complications. Pain was graded 2,8 in the SPAA group and 2,9 in the LA group, according to the AVS after 24 hours. Patients in the SPAA Group were more satisfied (7,5 versus 6,9 (<0.05. Same results were found for the cosmetic result (8,6 versus 7,4 (<0.05. Conclusion. Using the single port approach feasible and safe. The true benefit of the technique should be assessed by new randomised controlled trials.

A multi-centre clinical evaluation of reactive oxygen topical wound gel in 114 wounds.

Science.gov (United States)

Dryden, M; Dickinson, A; Brooks, J; Hudgell, L; Saeed, K; Cutting, K F

2016-03-01

This article reports the outcomes of the use of Surgihoney RO (SHRO), topical wound dressing in a multi-centre, international setting. The aims were to explore the clinical effects of SHRO, including a reduction in bacterial load and biofilm and improvement in healing in a variety of challenging non-healing and clinically infected wounds. This was a non-comparative evaluation, where both acute and chronic wounds with established delayed healing were treated with the dressing. Clinicians prospectively recorded wound improvement or deterioration, level of wound exudate, presence of pain, and presence of slough and necrosis. Analysis of this data provided information on clinical performance of the dressing. Semi-quantitative culture to assess bacterial bioburden was performed where possible. We recruited 104 patients, mean age 61 years old, with 114 wounds. The mean duration of wounds before treatment was 3.7 months and the mean duration of treatment was 25.7 days. During treatment 24 wounds (21%) healed and the remaining 90 (79%) wounds improved following application of the dressing. No deterioration in any wound was observed. A reduction in patient pain, level of wound exudate and in devitalised tissue were consistently reported. These positive improvements in wound progress were reflected in the wound cultures that showed a reduction in bacterial load in 39 out of the 40 swabs taken. There were two adverse events recorded: a stinging sensation following application of the dressing was experienced by 2 patients, and 2 elderly patients died of causes unrelated to the dressing or to the chronic wound. These patients' wounds and their response to SHRO have been included in the analysis. SHRO was well tolerated and shows great promise as an effective potent topical antimicrobial in the healing of challenging wounds. Matthew Dryden has become a shareholder in Matoke Holdings, the manufacturer of Surgihoney RO, since the completion of this study. Keith Cutting is a

Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China.

Science.gov (United States)

Zhao, Ling; Zhang, Fu-wen; Li, Ying; Wu, Xi; Zheng, Hui; Cheng, Lin-hao; Liang, Fan-rong

2011-03-24

In order to evaluate the safety of acupuncture in China objectively, we investigated the adverse events associated with acupuncture based on three multicentre randomized controlled trials (RCTs) to assess the safety of acupuncture, identifying the common types of acupuncture adverse events, and analysing the related risk factors for their occurrence. This observational study included patients who received acupuncture from three multicentre RCTs respectively for migraine, functional dyspepsia and Bell's palsy. The 1968 patients and their acupuncturists documented adverse events associated with acupuncture after treatment. We collected data about adverse events due to acupuncture treatment from their case report forms. We analysed the incidence and details of the adverse effects, and studied the risk factors for acupuncture adverse events with non-conditional logistic regression analysis. Among the 1968 patients, 74 patients (3.76%) suffered at least one adverse event throughout the treatment period. We did not observe the occurrence of serious adverse events. 73 patients with adverse events recovered within 2 weeks through effective treatment such as physiotherapy or self-treatment. A total of 3 patients withdrew because of adverse events. There were 9 types of adverse events related to acupuncture, including subcutaneous haematoma, bleeding, skin bruising and needle site pain. Subcutaneous haematoma and haemorrhage in the needling points were the most common adverse events. Age and gender were related to the occurrence of acupuncture adverse events. The older the patients were, the higher the risk of adverse events was. In addition, male patients had slightly higher risk of an adverse event than female patients. Acupuncture is a safe therapy with low risk of adverse events in clinical practice. The risk factors for adverse events (AEs) were related to the patients' gender and age and the local anatomical structure of the acupoints. AEs could be reduced and

RECIST response and variation of circulating tumour cells in phase 1 trials: A prospective multicentric study.

Science.gov (United States)

Massard, Christophe; Borget, Isabelle; Farace, Françoise; Aspeslagh, Sandrine; Le Deley, Marie-Cécile; Le Tourneau, Christophe; Bidard, François-Clement; Pierga, Jean-Yves; Dieras, Veronique; Hofman, Paul; Spano, Jean-Philippe; Ferte, Charles; Lacroix, Ludovic; Soria, Jean-Charles

2017-09-01

Circulating tumour cell (CTC) counting could be a new biomarker for better evaluation of tumour response to molecules tested in phase I trials. Consenting patients with advanced metastatic cancer referred to various phase I units were enrolled prospectively in this study. CTCs from 7.5 ml of whole blood drawn at baseline and after starting experimental therapy were counted using the CellSearch system, and tumour response was assessed using RECIST 1.1 criteria at baseline and 2 months after treatment initiation. Between March 2010 and May 2013, a total of 326 patients were enrolled, among whom 214 were evaluable (49% male, median age = 56; main cancer types: lung [28], colon [53], ovarian [18], breast [28]). At baseline, we detected ≥1 CTC/7.5 ml in 113/214 patients (53%), and at day 30, we observed ≥1 CTC/7.5 ml in 103/214 patients (48%). Two months after treatment initiation, 11 (5%) of the 214 patients were classified as having a partial response, with no CTCs in 9 of them or a decrease in the CTC count after therapy. In contrast, among the 104 patients (49%) classified as having progressive disease, 38 patients had a higher CTC count. The remaining 99 patients (49%), 33 of whom (33%) had a lower CTC count, were classified as having stable disease. The sensitivity and specificity of CTC variation for predicting progressive disease were 41% (32-51%) and 80% (73-88%) respectively. An early CTC change following therapy does not correlate with RECIST response in patients with advanced cancer enrolled in phase I trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

Cost-efficiency of specialist inpatient rehabilitation for working-aged adults with complex neurological disabilities: a multicentre cohort analysis of a national clinical data set.

Science.gov (United States)

Turner-Stokes, Lynne; Williams, Heather; Bill, Alan; Bassett, Paul; Sephton, Keith

2016-02-24

To evaluate functional outcomes, care needs and cost-efficiency of specialist rehabilitation for a multicentre cohort of inpatients with complex neurological disability, comparing different diagnostic groups across 3 levels of dependency. A multicentre cohort analysis of prospectively collected clinical data from the UK Rehabilitation Outcomes Collaborative (UKROC) national clinical database, 2010-2015. All 62 specialist (levels 1 and 2) rehabilitation services in England. Working-aged adults (16-65 years) with complex neurological disability. all episodes with length of stay (LOS) 8-400 days and complete outcome measures recorded on admission and discharge. Total N=5739: acquired brain injury n=4182 (73%); spinal cord injury n=506 (9%); peripheral neurological conditions n=282 (5%); progressive conditions n=769 (13%). Specialist inpatient multidisciplinary rehabilitation. Dependency and care costs: Northwick Park Dependency Scale/Care Needs Assessment (NPDS/NPCNA). Functional independence: UK Functional Assessment Measure (UK Functional Independence Measure (FIM)+FAM). Cost-efficiency: (1) time taken to offset rehabilitation costs by savings in NPCNA-estimated costs of ongoing care, (2) FIM efficiency (FIM gain/LOS days), (3) FIM+FAM efficiency (FIM+FAM gain/LOS days). Patients were analysed in 3 groups of dependency. Mean LOS 90.1 (SD 66) days. All groups showed significant reduction in dependency between admission and discharge on all measures (paired t tests: pSpecialist rehabilitation can be highly cost-efficient for all neurological conditions, producing substantial savings in ongoing care costs, especially in high-dependency patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Multicentre evaluation of a novel vaginal dose reporting method in 153 cervical cancer patients

DEFF Research Database (Denmark)

Westerveld, Henrike; de Leeuw, Astrid; Kirchheiner, Kathrin

2016-01-01

Background and purpose Recently, a vaginal dose reporting method for combined EBRT and BT in cervical cancer patients was proposed. The current study was to evaluate vaginal doses with this method in a multicentre setting, wherein different applicators, dose rates and protocols were used. Materia...

Multicentre Double-Blind Placebo-Controlled Food Challenge Study in Children Sensitised to Cashew Nut

NARCIS (Netherlands)

van der Valk, Johanna P. M.; van Wijk, Roy Gerth; Dubois, Anthony E. J.; de Groot, Hans; Reitsma, Marit; Vlieg-Boerstra, Berber; Savelkoul, Huub F. J.; Wichers, Harry J.; de Jong, Nicolette W.

2016-01-01

Background Few studies with a limited number of patients have provided indications that cashew-allergic patients may experience severe allergic reactions to minimal amounts of cashew nut. The objectives of this multicentre study were to assess the clinical relevance of cashew nut sensitisation, to

Uptake of breast cancer preventive therapy in the UK: results from a multicentre prospective survey and qualitative interviews.

Science.gov (United States)

Hackett, Julia; Thorneloe, Rachael; Side, Lucy; Wolf, Michael; Horne, Rob; Cuzick, Jack; Smith, Samuel G

2018-04-24

Uptake of preventive therapy for women at increased breast cancer risk in England is unknown following the introduction of UK clinical guidelines in 2013. Preventive therapy could create socioeconomic inequalities in cancer incidence if it is more readily accepted by particular socio-demographic groups. In this multicentre study, we investigated uptake of tamoxifen and evaluated socio-demographic and clinical factors associated with initiation. We explored women's experiences of treatment decision-making using qualitative interview data. Between September 2015 and December 2016, women (n = 732) attending an appointment at one of 20 centres in England to discuss breast cancer risk were approached to complete a survey containing socio-demographic details and nulliparity. Of the baseline survey respondents (n = 408/732, 55.7% response rate), self-reported uptake of tamoxifen at 3-month follow-up was reported in 258 (63.2%). Sixteen women participated in semi-structured interviews. One in seven (38/258 = 14.7%) women initiated tamoxifen. Women who had children were more likely to report use of tamoxifen than those without children (OR = 5.26; 95%CI: 1.13-24.49, p = 0.035). Interview data suggested that women weigh up risks and benefits of tamoxifen within the context of familial commitments, with exposure to significant other's beliefs and experiences of cancer and medication a basis for their decision. Uptake of tamoxifen is low in clinical practice. There were no socio-demographic differences in uptake, suggesting that the introduction of breast cancer preventive therapy is unlikely to create socioeconomic inequalities in cancer incidence. Women's decision-making was influenced by familial priorities, particularly having children.

The vascularised fibular graft for limb salvage after bone tumour surgery A MULTICENTRE STUDY

NARCIS (Netherlands)

Hilven, P. H.; Bayliss, L.; Cosker, T.; Dijkstra, P. D. S.; Jutte, P. C.; Lahoda, L. U.; Schaap, G. R.; Bramer, J. A. M.; van Drunen, G. K.; Strackee, S. D.; van Vooren, J.; Gibbons, M.; Giele, H.; van de Sande, M. A. J.

2015-01-01

Vascularised fibular grafts (VFGs) are a valuable surgical technique in limb salvage after resection of a tumour. The primary objective of this multicentre study was to assess the risk factors for failure and complications for using a VFG after resection of a tumour. The study involved 74

Prevalence and predictors of alcohol use during pregnancy: findings from international multicentre cohort studies.

Science.gov (United States)

O'Keeffe, Linda M; Kearney, Patricia M; McCarthy, Fergus P; Khashan, Ali S; Greene, Richard A; North, Robyn A; Poston, Lucilla; McCowan, Lesley M E; Baker, Philip N; Dekker, Gus A; Walker, James J; Taylor, Rennae; Kenny, Louise C

2015-07-06

To compare the prevalence and predictors of alcohol use in multiple cohorts. Cross-cohort comparison of retrospective and prospective studies. Population-based studies in Ireland, the UK, Australia and New Zealand. 17,244 women of predominantly Caucasian origin from two Irish retrospective studies (Growing up in Ireland (GUI) and Pregnancy Risk Assessment Monitoring System Ireland (PRAMS Ireland)), and one multicentre prospective international cohort, Screening for Pregnancy Endpoints (SCOPE) study. Prevalence of alcohol use pre-pregnancy and during pregnancy across cohorts. Sociodemographic factors associated with alcohol consumption in each cohort. Alcohol consumption during pregnancy in Ireland ranged from 20% in GUI to 80% in SCOPE, and from 40% to 80% in Australia, New Zealand and the UK. Levels of exposure also varied substantially among drinkers in each cohort ranging from 70% consuming more than 1-2 units/week in the first trimester in SCOPE Ireland, to 46% and 15% in the retrospective studies. Smoking during pregnancy was the most consistent predictor of gestational alcohol use in all three cohorts, and smokers were 17% more likely to drink during pregnancy in SCOPE, relative risk (RR)=1.17 (95% CI 1.12 to 1.22), 50% more likely to drink during pregnancy in GUI, RR=1.50 (95% CI 1.36 to 1.65), and 42% more likely to drink in PRAMS, RR=1.42 (95% CI 1.18 to 1.70). Our data suggest that alcohol use during pregnancy is prevalent and socially pervasive in the UK, Ireland, New Zealand and Australia. New policy and interventions are required to reduce alcohol prevalence both prior to and during pregnancy. Further research on biological markers and conventions for measuring alcohol use in pregnancy is required to improve the validity and reliability of prevalence estimates. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Lymphoscintigraphy and SPECT/CT in multicentric and multifocal breast cancer: does each tumour have a separate drainage pattern? Results of a Dutch multicentre study (MULTISENT)

Energy Technology Data Exchange (ETDEWEB)

Brouwer, O.R. [Antoni van Leeuwenhoek Hospital, Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam (Netherlands); Antoni van Leeuwenhoekhospital, Amsterdam (Netherlands); Vermeeren, L.; Valdes Olmos, R.A. [Antoni van Leeuwenhoek Hospital, Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam (Netherlands); Ploeg, I.M.C. van der; Rutgers, E.J.T.; Oldenburg, H.S.A. [Antoni van Leeuwenhoek Hospital, Department of Surgery, Netherlands Cancer Institute, Amsterdam (Netherlands); Loo, C.E. [Antoni van Leeuwenhoek Hospital, Department of Radiology, Netherlands Cancer Institute, Amsterdam (Netherlands); Pereira-Bouda, L.M.; Smit, F. [Rijnland Hospital, Department of Nuclear Medicine, Leiderdorp (Netherlands); Neijenhuis, P. [Rijnland Hospital, Department of Surgery, Leiderdorp (Netherlands); Vrouenraets, B.C. [Sint Lucas Andreas Hospital, Department of Surgery, Amsterdam (Netherlands); Sivro-Prndelj, F. [Sint Lucas Andreas Hospital, Department of Nuclear Medicine, Amsterdam (Netherlands); Jap-a-Joe, S.M.; Borgstein, P.J. [Onze Lieve Vrouwe Gasthuis, Department of Nuclear Medicine, Amsterdam (Netherlands)

2012-07-15

To investigate whether lymphoscintigraphy and SPECT/CT after intralesional injection of radiopharmaceutical into each tumour separately in patients with multiple malignancies in one breast yields additional sentinel nodes compared to intralesional injection of the largest tumour only. Patients were included prospectively at four centres in The Netherlands. Lymphatic flow was studied using planar lymphoscintigraphy and SPECT/CT until 4 h after administration of {sup 99m}Tc-nanocolloid in the largest tumour. Subsequently, the smaller tumour(s) was injected intratumorally followed by the same imaging sequence. Sentinel nodes were intraoperatively localized using a gamma ray detection probe and vital blue dye. Included in the study were 50 patients. Additional lymphatic drainage was depicted after the second and/or third injection in 32 patients (64 %). Comparison of planar images and SPECT/CT images after consecutive injections enabled visualization of the number and location of additional sentinel nodes (32 axillary, 11 internal mammary chain, 2 intramammary, and 1 interpectoral. A sentinel node contained metastases in 17 patients (34 %)). In five patients with a tumour-positive node in the axilla that was visualized after the first injection, an additional involved axillary node was found after the second injection. In two patients, isolated tumour cells were found in sentinel nodes that were only visualized after the second injection, whilst the sentinel nodes identified after the first injection were tumour-negative. Lymphoscintigraphy and SPECT/CT after consecutive intratumoral injections of tracer enable lymphatic mapping of each tumour separately in patients with multiple malignancies within one breast. The high incidence of additional sentinel nodes draining from tumours other than the largest one suggests that separate tumour-related tracer injections may be a more accurate approach to mapping and sampling of sentinel nodes in patients with multicentric or

Lymphoscintigraphy and SPECT/CT in multicentric and multifocal breast cancer: does each tumour have a separate drainage pattern? Results of a Dutch multicentre study (MULTISENT).

Science.gov (United States)

Brouwer, O R; Vermeeren, L; van der Ploeg, I M C; Valdés Olmos, R A; Loo, C E; Pereira-Bouda, L M; Smit, F; Neijenhuis, P; Vrouenraets, B C; Sivro-Prndelj, F; Jap-a-Joe, S M; Borgstein, P J; Rutgers, E J Th; Oldenburg, H S A

2012-07-01

To investigate whether lymphoscintigraphy and SPECT/CT after intralesional injection of radiopharmaceutical into each tumour separately in patients with multiple malignancies in one breast yields additional sentinel nodes compared to intralesional injection of the largest tumour only. Patients were included prospectively at four centres in The Netherlands. Lymphatic flow was studied using planar lymphoscintigraphy and SPECT/CT until 4 h after administration of (99m)Tc-nanocolloid in the largest tumour. Subsequently, the smaller tumour(s) was injected intratumorally followed by the same imaging sequence. Sentinel nodes were intraoperatively localized using a gamma ray detection probe and vital blue dye. Included in the study were 50 patients. Additional lymphatic drainage was depicted after the second and/or third injection in 32 patients (64%). Comparison of planar images and SPECT/CT images after consecutive injections enabled visualization of the number and location of additional sentinel nodes (32 axillary, 11 internal mammary chain, 2 intramammary, and 1 interpectoral. A sentinel node contained metastases in 17 patients (34%). In five patients with a tumour-positive node in the axilla that was visualized after the first injection, an additional involved axillary node was found after the second injection. In two patients, isolated tumour cells were found in sentinel nodes that were only visualized after the second injection, whilst the sentinel nodes identified after the first injection were tumour-negative. Lymphoscintigraphy and SPECT/CT after consecutive intratumoral injections of tracer enable lymphatic mapping of each tumour separately in patients with multiple malignancies within one breast. The high incidence of additional sentinel nodes draining from tumours other than the largest one suggests that separate tumour-related tracer injections may be a more accurate approach to mapping and sampling of sentinel nodes in patients with multicentric or

MULTICENTRIC T-CELL LYMPHOMA AND CUTANEOUS HEMANGIOSARCOMA IN A CAPTIVE CHEETAH (ACINONYX JUBATUS).

Science.gov (United States)

Lindemann, Dana M; Carpenter, James W; Nietfeld, Jerome C; Gonzalez, Estehela; Hallman, Mackenzie; Hause, Ben M

2015-12-01

A 13-yr-old intact male cheetah (Acinonyx jubatus) presented for evaluation after a 4-mo history of intermittent lethargy and increased expiratory effort. The clinical signs were initially noted after the diagnosis and death of its 13-yr-old male sibling with solitary hepatic T-cell lymphoma. Physical examination findings included thin body condition, harsh lung sounds, peripheral lymphadenopathy, and a cutaneous mass on the right medial tarsus and scrotum. Excisional biopsies diagnosed well-differentiated cutaneous hemangiosarcomas. Thoracic radiographs revealed a cranial mediastinal mass. Complete blood count and serum biochemical analyses showed a leukocytosis with persistent lymphocytosis, progressive azotemia, and markedly elevated alkaline phosphatase. Because of the cheetah's declining quality of life, euthanasia was elected. Postmortem examination, histopathology, and immunohistochemical staining revealed multicentric T-cell lymphoma. Feline leukemia virus (FeLV) enzyme-linked immunosorbent assay, FeLV polymerase chain reaction (whole blood), and viral metagenomic analysis were negative. This is the first case of cutaneous hemangiosarcoma and multicentric T-cell lymphoma reported in a FeLV-negative cheetah.

Imaging features of multicentric Castleman's disease in HIV infection

International Nuclear Information System (INIS)

Hillier, J.C.; Shaw, P.; Miller, R.F.; Cartledge, J.D.; Nelson, M.; Bower, M.; Francis, N.; Padley, S.P.

2004-01-01

AIM: To describe the computed tomography (CT) features of human immunodeficiency virus (HIV)-associated Castleman's disease. MATERIALS AND METHODS: Nine HIV-positive patients with biopsy-proven Castleman's disease were studied. Clinical and demographic data, CD4 count, histological diagnosis and human herpes type 8 (HHV8) serology or immunostaining results were recorded. CT images were reviewed independently by two radiologists. RESULTS: CT findings included splenomegaly (n=7) and peripheral lymph node enlargement (axillary n=8, inguinal n=4). All nodes displayed mild to avid enhancement after intravenous administration of contrast material. Hepatomegaly was evident in seven patients. Other features included abdominal (n=6) and mediastinal (n=5) lymph node enlargement and pulmonary abnormalities (n=4). Patterns of parenchymal abnormality included bronchovascular nodularity (n=2), consolidation (n=1) and pleural effusion (n=2). On histological examination eight patients (spleen n=3, lymph node n=9, lung n=1 bone marrow n=1) had the plasma cell variant and one had mixed hyaline-vascular/plasma cell variant. The majority had either positive immunostaining for HHV8 or positive serology (n=8). CONCLUSION: Common imaging features of multicentric Castleman's disease in HIV infection are hepatosplenomegaly and peripheral lymph node enlargement. Although these imaging features may suggest the diagnosis in the appropriate clinical context, they lack specificity and so biopsy is needed for diagnosis. In distinction from multicentric Castleman's disease in other populations the plasma cell variant is most commonly encountered, splenomegaly is a universal feature and there is a strong association with Kaposi's sarcoma

Non-observance of guidelines for surgical antimicrobial prophylaxis and surgical-site infections.

Science.gov (United States)

Lallemand, S; Thouverez, M; Bailly, P; Bertrand, X; Talon, D

2002-06-01

A prospective multicentre study was conducted to assess major aspects of surgical prophylaxis and to determine whether inappropriate antimicrobial prophylaxis was a factor associated (risk or protective factor) with surgical site infection (SSI). Surgical prophylaxis practices were assessed by analysing four variables: indication, antimicrobial agent, timing and duration. Univariate and multivariate analyses were carried out to identify predictors of SSI among patient-specific, operation-specific and antimicrobial prophylaxis-specific factors. The frequency of SSI was 2.7% (13 SSI in 474 observations). Total compliance of the prescription with guidelines was observed in 41.1% of cases (195 prescriptions). Of the 139 patients who received an inappropriate drug, 126 (90.6%) received a drug with a broader spectrum than the recommended drug. Prophylaxis was prolonged in 71 (87.7%) of the 81 patients who received prophylaxis for inappropriate lengths of time and 43 (61.4%) of the 70 patients who did not receive prophylaxis at the optimal moment were treated too late. Multivariate analysis clearly demonstrated that SSI was associated with multiple procedures (relative risk 8.5), short duration of prophylaxis (relative risk 12.7) and long-term therapy with antimicrobial agents during the previous year (relative risk 8.8). The ecological risk of the emergence of resistance associated with the frequent use of broad-spectrum antibiotics and prophylaxis for longer periods was not offset by individual benefit to the patients who received inappropriate prophylaxis.

Multicentre European study of thalamic stimulation for parkinsonian tremor: a 6 year follow-up

NARCIS (Netherlands)

Hariz, M. I.; Krack, P.; Alesch, F.; Augustinsson, L.-E.; Bosch, A.; Ekberg, R.; Johansson, F.; Johnels, B.; Meyerson, B. A.; N'Guyen, J.-P.; Pinter, M.; Pollak, P.; von Raison, F.; Rehncrona, S.; Speelman, J. D.; Sydow, O.; Benabid, A.-L.

2008-01-01

To evaluate the results of ventral intermediate (Vim) thalamic deep brain stimulation (DBS) in patients with tremor predominant Parkinson's disease (PD) at 6 years post surgery. This was a prolonged follow-up study of 38 patients from eight centres who participated in a multicentre study, the 1 year

Multicentric malignant gastrointestinal stromal tumor

International Nuclear Information System (INIS)

Shukla, Shailaja; Singh, Sanjeet K; Pujani, Mukta

2009-01-01

Malignant gastrointestinal stromal tumor (GIST) is a rare type of sarcoma that is found in the digestive system, most often in the wall of the stomach. Multiple GISTs are extremely rare and usually associated with type 1 neurofibromatosis and familial GIST. We report here a case of a 70-year-old woman who reported pain in the abdomen, loss of appetite, and weight loss for six months. Ultrasound examination showed a small bowel mass along with multiple peritoneal deposits and a mass within the liver. Barium studies were suggestive of a neoplastic pathology of the distal ileum. A differential diagnosis of adenocarcinoma/lymphoma with metastases was entertained. Perioperative findings showed two large growths arising from the jejunum and the distal ileum, along with multiple smaller nodules on the serosal surface and adjoining mesentery of the involved bowel segments. Segmental resection of the involved portions of the intestine was performed. Histopathological features were consistent with those of multicentric malignant GIST-not otherwise specified (GIST-NOS). Follow-up examination three months after surgery showed no evidence of recurrence. (author)

Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial.

Science.gov (United States)

Bolinder, Jan; Antuna, Ramiro; Geelhoed-Duijvestijn, Petronella; Kröger, Jens; Weitgasser, Raimund

2016-11-05

Tight control of blood glucose in type 1 diabetes delays onset of macrovascular and microvascular diabetic complications; however, glucose levels need to be closely monitored to prevent hypoglycaemia. We aimed to assess whether a factory-calibrated, sensor-based, flash glucose-monitoring system compared with self-monitored glucose testing reduced exposure to hypoglycaemia in patients with type 1 diabetes. In this multicentre, prospective, non-masked, randomised controlled trial, we enrolled adult patients with well controlled type 1 diabetes (HbA 1c ≤58 mmol/mol [7·5%]) from 23 European diabetes centres. After 2 weeks of all participants wearing the blinded sensor, those with readings for at least 50% of the period were randomly assigned (1:1) to flash sensor-based glucose monitoring (intervention group) or to self-monitoring of blood glucose with capillary strips (control group). Randomisation was done centrally using the biased-coin minimisation method dependent on study centre and type of insulin administration. Participants, investigators, and study staff were not masked to group allocation. The primary outcome was change in time in hypoglycaemia (diabetes spent in hypoglycaemia. Future studies are needed to assess the effectiveness of this technology in patients with less well controlled diabetes and in younger age groups. Abbott Diabetes Care. Copyright © 2016 Elsevier Ltd. All rights reserved.

Antibiotic prescription strategies for acute sore throat: a prospective observational cohort study.

Science.gov (United States)

Little, Paul; Stuart, Beth; Hobbs, F D Richard; Butler, Chris C; Hay, Alastair D; Delaney, Brendan; Campbell, John; Broomfield, Sue; Barratt, Paula; Hood, Kerenza; Everitt, Hazel; Mullee, Mark; Williamson, Ian; Mant, David; Moore, Michael

2014-03-01

Data from trials suggest that antibiotics reduce the risk of complications of sore throat by at least 50%, but few trials for complications have been done in modern settings, and datasets of delayed antibiotic prescription are underpowered. Observational evidence is important in view of poor compliance with antibiotic treatment outside trials, but no prospective observational cohort studies have been done to date. We generated a large prospective cohort from the DESCARTE study, and the PRISM component of DESCARTE, of 12,829 adults presenting with sore throat (≤ 2 weeks duration) in primary care. Our follow-up of the cohort was based on a detailed and structured review of routine medical records, and analysis of the comparison of three antibiotic prescription strategies (no antibiotic prescription, immediate antibiotic prescription, and delayed antibiotic prescription) to control for the propensity to prescribe antibiotics. Information about antibiotic prescription was recorded in 12,677 individuals (4805 prescribed no antibiotics, 6088 prescribed antibiotics immediately, and 1784 prescribed delayed antibiotics). We documented by review of patients' notes (n=11,950) the development of suppurative complications (eg, quinsy, impetigo and cellulitis, otitis media, and sinusitis) or reconsultation with new or non-resolving symptoms). We used multivariate analysis to control for variables significantly related to the propensity to prescribe antibiotics and for clustering by general practitioner. 164 (1.4%) of the 11,950 patients with information available developed complications; otitis media and sinusitis were the most common complications (101 patients [62%]). Compared with no antibiotic prescription, immediate antibiotic prescription was associated with fewer complications (adjusted risk ratio [RR] 0.62, 95% CI 0.43-0.91, estimated number needed to treat [NNT 193) as was delayed prescription of antibiotics (0.58, 0.34-0.98; NNT 174). 1787 of the 11,950 patients (15

A multicentre molecular analysis of hepatitis B and blood-borne virus coinfections in Viet Nam.

Science.gov (United States)

Dunford, Linda; Carr, Michael J; Dean, Jonathan; Nguyen, Linh Thuy; Ta Thi, Thu Hong; Nguyen, Binh Thanh; Connell, Jeff; Coughlan, Suzie; Nguyen, Hien Tran; Hall, William W; Thi, Lan Anh Nguyen

2012-01-01

Hepatitis B (HBV) infection is endemic in Viet Nam, with up to 8.4 million individuals estimated to be chronically infected. We describe results of a large, multicentre seroepidemiological and molecular study of the prevalence of HBV infection and blood-borne viral coinfections in Viet Nam. Individuals with varying risk factors for infection (n = 8654) were recruited from five centres; Ha Noi, Hai Phong, Da Nang, Khanh Hoa and Can Tho. A mean prevalence rate of 10.7% was observed and levels of HBsAg were significantly higher in injecting drug users (IDUs) (17.4%, n = 174/1000) and dialysis patients (14.3%, n = 82/575) than in lower-risk groups (9.4%; pViet Nam and also highlights the significant levels of blood-borne virus coinfections, which have important implications for hepatitis-related morbidity and development of effective management strategies.

No efficacy of annual gynaecological screening in BRCA1/2 mutation carriers; an observational follow-up study

NARCIS (Netherlands)

Hermsen, B. B. J.; Olivier, R. I.; Verheijen, R. H. M.; van Beurden, M.; de Hullu, J. A.; Massuger, L. F.; Burger, C. W.; Brekelmans, C. T.; Mourits, M. J.; de Bock, G. H.; Gaarenstroom, K. N.; van Boven, H. H.; Mooij, T. M.; Rookus, M. A.

2007-01-01

BRCA1/ 2 mutation carriers are offered gynaecological screening with the intention to reduce mortality by detecting ovarian cancer at an early stage. We examined compliance and efficacy of gynaecological screening in BRCA1/ 2 mutation carriers. In this multicentre, observational, follow-up study we

Naturalistic Observations to Investigate Conflicts Between Drivers and VRUs in the PROSPECT Project

OpenAIRE

BRUYAS, Marie-Pierre; APARICIO, Andrés; KOSEL, Miklos; AMBELLOUIS, Sébastien; ESTRAILLIER, Céline; MOREAU, Fabien; SANZ, Laura; COSTA, Joan; SOLTESZ, Tamas; BANFI, Miklos

2017-01-01

ESV 2017 - 25th International Technical Conference on the Enhanced Safety of Vehicles, DETROIT, ETATS-UNIS, 05-/06/2017 - 08/06/2017; PROSPECT aims at developing a new generation of proactive safety systems to protect Vulnerable Road Users (VRUs), with an emphasis on pedestrians and cyclists. To improve sensor effectiveness, PROSPECT will expand the scope of scenarios addressed by sensors already on the market, enhancing their overall performance. Interactions between vehicles and VRUs were i...

Multicentric osteoid osteoma with a nidus located in the epiphysis

International Nuclear Information System (INIS)

Tamam, Cueneyt; Yildirim, Duezguen; Tamam, Muge

2009-01-01

We present a 13-year-old girl who was referred to our clinic with a 5-month history of right leg pain relieved by salicylates. Initial CT examination demonstrated a lesion in the posterior tibial cortex in keeping with an osteoid osteoma. This was resected and the diagnosis confirmed by histology. However, her pain recurred 2 weeks after the operation and further imaging identified a further nidus in the epiphysis. We present the imaging findings in this unique case of multicentric osteoid osteoma with one nidus located in the epiphysis. (orig.)

Clinical observed performance evaluation: a prospective study in final year students of surgery.

LENUS (Irish Health Repository)

Markey, G C

2010-06-24

We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series of assessments in a 25-week teaching programme. Over time, several clinicians from a pool of 16 surgical consultants and registrars evaluated each student by direct observation. A structured rating form was used for assessment data. Variance component analysis (VCA), internal consistency and inter-rater agreement were used to estimate reliability. The predictive and convergent validity of COPE in relation to summative OSCE, long case, and overall final examination was estimated. Median number of COPE assessments per student was 7. Generalisability of a mean score over 7 COPE assessments was 0.66, equal to that of an 8 x 7.5 min station final OSCE. Internal consistency was 0.88-0.97 and inter-rater agreement 0.82. Significant correlations were observed with OSCE performance (R = 0.55 disattenuated) and long case (R = 0.47 disattenuated). Convergent validity was 0.81 by VCA. Overall final examination performance was linearly related to mean COPE score with standard error 3.7%. COPE permitted efficient serial assessment of a large cohort of final year students in a real world setting. Its psychometric quality compared well with conventional assessments and with other direct observation instruments as reported in the literature. Effect on learning, and translation to clinical care, are directions for future research.

Case report 558: Multicentric Klebsiella pneumoniae (Friedlaenders bacillus) osteomyelitis in sickle cell anemia

International Nuclear Information System (INIS)

Malpani, A.R.; Sundaram, M.; Ramani, S.K.

1989-01-01

This patient represents a unique combination of multicentric osteomyelitis due to Klebsiella pneumoniae, lesions in the skull, pathological fracture of a long bone and no evidence of pulmonary disease. That Klebsiella pneumoniae osteomyelitis can occur in sickle cell anemia should be considered when such bone changes are seen. The remarkable resolution on conservative management also needs to be noted. (orig./GDG)

A Multi-centric, Double-blind, Placebo-controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of Carica papaya Leaf Extract, as Empirical Therapy for Thrombocytopenia associated with Dengue Fever.

Science.gov (United States)

Kasture, Prabhu Nagnathappa; Nagabhushan, K H; Kumar, Arun

2016-06-01

Dengue is a rapidly expanding global health problem. Approximately 2.5 billion people live in dengue-risk regions with about 100 million new cases each year worldwide. The cumulative dengue diseases burden has attained an unprecedented proportion in recent times with sharp increase in the size of human population at risk. The management of dengue virus infection is essentially supportive and symptomatic and no specific treatment is available for increasing the fallen platelets, which have a significant role in causing the mortality of dengue patient.This study was conducted to evaluate the platelet increasing efficacy of Carica papaya leaf extract (CPLE) in patients with dengue fever (DF). The administration of Carica papaya leaf extract should significantly increase the platelet count in cases of thrombocytopenia associated with dengue, preventing the patient to go in DHF or DSS conditions. A Multi-centric, Double blind, Placebo controlled, Randomized, prospective study was conducted in 300 patients across 5 centres', to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue fever. The subjects were randomized into two groups, as control and intervention group. Both the groups were managed by the standard management guidelines for dengue except steroid administration. In addition to this, the intervention group received CPLE tablet three times daily for five days. All of them were followed daily with platelet monitoring. This study has been registered in the clinical trial registry-India (CTRI Registration number: CTRI/2015/05/005806). The results indicate that CPLE had significant increase(p< 0.01) in the platelet count over the therapy duration, in dengue fever patients, confirming CPLE accelerates the increase in platelet count compared to the control group. There were few adverse events related to GI disturbance like nausea and vomiting which were similar in both groups. Thus this study

Hard X-ray Emission from Galaxy Clusters Observed with INTEGRAL and Prospects for Simbol-X

Science.gov (United States)

Eckert, D.; Paltani, S.; Courvoisier, T. J.-L.

2009-05-01

Some galaxy clusters are known to contain a large population of relativistic electrons, which produce radio emission through synchrotron radiation. Therefore, it is expected that inverse-Compton scattering of the relativistic electrons with the CMB produce non-thermal emission which should be observable in the hard X-ray domain. Here we focus on the recent results by INTEGRAL, which shed a new light on the non-thermal emission thanks to its angular resolution and sensitivity in the hard X-ray range. We also present the exciting prospects in this field for Simbol-X, which will allow us to detect the non-thermal emission in a number of clusters and map the magnetic field throughout the intra-cluster medium.

European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study: rationale, design and population characteristics

DEFF Research Database (Denmark)

Slimani, N.; Kaaks, R.; Ferrari, P.

2002-01-01

The European Prospective Investigation into Cancer and Nutrition (EPIC), which covers a large cohort of half a million men and women from 23 European centres in 10 Western European countries, was designed to study the relationship between diet and the risk of chronic diseases, particularly cancer......, a calibration approach was developed. This approach involved an additional dietary assessment common across study populations to re-express individual dietary intakes according to the same reference scale. A single 24-hour diet recall was therefore collected, as the EPIC reference calibration method, from...... in a large multi-centre European study. These studies showed that, despite certain inherent methodological and logistic constraints, a study design such as this one works relatively well in practice. The average response in the calibration study was 78.3% and ranged from 46.5% to 92.5%. The calibration...

Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis.

Science.gov (United States)

Arch, Barbara N; Blair, Joanne; McKay, Andrew; Gregory, John W; Newland, Paul; Gamble, Carrol

2016-10-24

Glycated haemoglobin (HbA1c) is an important outcome measure in diabetes clinical trials. For multicentre designs, HbA1c can be measured locally at participating centres or by sending blood samples to a central laboratory. This study analyses the agreement between local and central measurements, using 1-year follow-up data collected in a multicentre randomised controlled trial (RCT) of newly diagnosed children with type I diabetes. HbA1c measurements were routinely analysed both locally and centrally at baseline and then at 3, 6, 9 and 12 months and the data reported in mmol/mol. Agreement was assessed by calculating the bias and 95 % limits of agreement, using the Bland-Altman analysis method. A predetermined benchmark for clinically acceptable margin of error between measurements was subjectively set as ±10 % for HbA1c. The percentage of pairs of measurements that were classified as clinically acceptable was calculated. Descriptive statistics were used to examine the agreement within centres. Treatment group was not considered. Five hundred and ninety pairs of measurement, representing 255 children and 15 trial centres across four follow-up time points, were compared. There was no significant bias: local measurements were an average of 0.16 mmol/mol (SD = 4.5, 95 % CI -0.2 to 0.5) higher than central. The 95 % limits of agreement were -8.6 to 9.0 mmol/mol (local minus central). Eighty percent of local measurements were within ±10 % of corresponding central measurements. Some trial centres were more varied in the differences observed between local and central measurements: IQRs ranging from 3 to 9 mmol/mol; none indicated systematic bias. Variation in agreement between HbA1c measurements was greater than had been expected although no overall bias was detected and standard deviations were similar. Discrepancies were present across all participating centres. These findings have implications for the comparison of standards of clinical care between centres

Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

NARCIS (Netherlands)

Nauth, A. (Aaron); Creek, A.T. (Aaron T.); Zellar, A. (Abby); Lawendy, A.-R. (Abdel-Rahman); Dowrick, A. (Adam); Gupta, A. (Ajay); Dadi, A. (Akhil); A. van Kampen (A.); Yee, A. (Albert); A.C. de Vries (Alexander); de Mol van Otterloo, A. (Alexander); Garibaldi, A. (Alisha); Liew, A. (Allen); McIntyre, A.W. (Allison W.); Prasad, A.S. (Amal Shankar); Romero, A.W. (Amanda W.); Rangan, A. (Amar); Oatt, A. (Amber); Sanghavi, A. (Amir); Foley, A.L. (Amy L.); Karlsten, A. (Anders); Dolenc, A. (Andrea); Bucknill, A. (Andrew); Chia, A. (Andrew); Evans, A. (Andrew); Gong, A. (Andrew); Schmidt, A.H. (Andrew H.); Marcantonio, A.J. (Andrew J.); Jennings, A. (Andrew); Ward, A. (Angela); Khanna, A. (Angshuman); Rai, A. (Anil); Smits, A.B. (Anke B.); Horan, A.D. (Annamarie D.); Brekke, A.C. (Anne Christine); Flynn, A. (Annette); Duraikannan, A. (Aravin); Stødle, A. (Are); van Vugt, A.B. (Arie B.); Luther, A. (Arlene); Zurcher, A.W. (Arthur W.); Jain, A. (Arvind); Amundsen, A. (Asgeir); Moaveni, A. (Ash); Carr, A. (Ashley); Sharma, A. (Ateet); Hill, A.D. (Austin D.); Trommer, A. (Axel); Rai, B.S. (B. Sachidananda); Hileman, B. (Barbara); Schreurs, B. (Bart); Verhoeven, B. (Bart); Barden, B.B. (Benjamin B.); Flatøy, B. (Bernhard); B.I. Cleffken (Berry); Bøe, B. (Berthe); Perey, B. (Bertrand); Hanusch, B.C. (Birgit C.); Weening, B. (Brad); B. Fioole (Bram); Rijbroek, B. (Bram); Crist, B.D. (Brett D.); Halliday, B. (Brett); Peterson, B. (Brett); Mullis, B. (Brian); Richardson, C.G. (C. Glen); Clark, C. (Callum); Sagebien, C.A. (Carlos A.); C. van der Pol (Carmen); Bowler, C. (Carol); Humphrey, C.A. (Catherine A.); Coady, C. (Catherine); Koppert, C.L. (Cees L.); Coles, C. (Chad); Tannoury, C. (Chadi); DePaolo, C.J. (Charles J.); Gayton, C. (Chris); Herriott, C. (Chris); Reeves, C. (Christina); Tieszer, C. (Christina); Dobb, C. (Christine); Anderson, C.G. (Christopher G.); Sage, C. (Claire); Cuento, C. (Claudine); Jones, C.B. (Clifford B.); Bosman, C.H.R. (Coks H.R.); Linehan, C. (Colleen); C.P. van der Hart (Cor P.); Henderson, C. (Corey); Lewis, C.G. (Courtland G.); Davis, C.A. (Craig A.); Donohue, C. (Craig); Mauffrey, C. (Cyril); Sundaresh, D.C. (D. C.); Farrell, D.J. (Dana J.); Whelan, D.B. (Daniel B.); Horwitz, D. (Daniel); Stinner, D. (Daniel); Viskontas, D. (Darius); Roffey, D.M. (Darren M.); Alexander, D. (David); Karges, D.E. (David E.); Hak, D. (David); Johnston, D. (David); Love, D. (David); Wright, D.M. (David M.); Zamorano, D.P. (David P.); Goetz, D.R. (David R.); Sanders, D. (David); Stephen, D. (David); Yen, D. (David); Bardana, D. (Davide); Olakkengil, D.J. (Davy J); Lawson, D. (Deanna); Maddock, D. (Deborah); Sietsema, D.L. (Debra L.); Pourmand, D. (Deeba); D. den Hartog (Dennis); Donegan, D. (Derek); D. Heels-Ansdell (Diane); Nam, D. (Diane); Inman, D. (Dominic); Boyer, D. (Dory); Li, D. (Doug); Gibula, D. (Douglas); Price, D.M. (Dustin M.); Watson, D.J. (Dylan J.); Hammerberg, E.M. (E. Mark); Tan, E.T.C.H. (Edward T.C.H.); E.J.R. de Graaf (Eelco); Vesterhus, E.B. (Elise Berg); Roper, E. (Elizabeth); Edwards, E. (Elton); E.H. Schemitsch (Emil); E.R. Hammacher (Eric); Henderson, E.R. (Eric R.); Whatley, E. (Erica); Torres, E.T. (Erick T.); Vermeulen, E.G.J. (Erik G.J.); Finn, E. (Erin); E.M.M. van Lieshout (Esther); Wai, E.K. (Eugene K.); Bannister, E.R. (Evan R.); Kile, E. (Evelyn); Theunissen, E.B.M. (Evert B.M.); Ritchie, E.D. (Ewan D.); Khan, F. (Farah); Moola, F. (Farhad); Howells, F. (Fiona); F. de Nies (Frank); F.H.W.M. van der Heijden (Frank); de Meulemeester, F.R.A.J. (Frank R.A.J.); F. Frihagen (Frede); Nilsen, F. (Fredrik); Schmidt, G.B. (G. Ben); Albers, G.H.R. (G.H. Robert); Gudger, G.K. (Garland K.); Johnson, G. (Garth); Gruen, G. (Gary); Zohman, G. (Gary); Sharma, G. (Gaurav); Wood, G. (Gavin); G.W.M. Tetteroo (Geert); Hjorthaug, G. (Geir); Jomaas, G. (Geir); Donald, G. (Geoff); Rieser, G.R. (Geoffrey Ryan); Reardon, G. (Gerald); Slobogean, G.P. (Gerard P.); G.R. Roukema (Gert); Visser, G.A. (Gijs A.); Moatshe, G. (Gilbert); Horner, G. (Gillian); Rose, G. (Glynis); Guyatt, G. (Gordon); Chuter, G. (Graham); Etherington, G. (Greg); Rocca, G.J.D. (Gregory J. Della); Ekås, G. (Guri); Dobbin, G. (Gwendolyn); Lemke, H.M. (H. Michael); Curry, H. (Hamish); H. Boxma (Han); Gissel, H. (Hannah); Kreder, H. (Hans); Kuiken, H. (Hans); H.L.F. Brom; Pape, H.-C. (Hans-Christoph); H.M. van der Vis (Harm); Bedi, H. (Harvinder); Vallier, H.A. (Heather A.); Brien, H. (Heather); Silva, H. (Heather); Newman, H. (Heike); H. Viveiros (Helena); van der Hoeven, H. (Henk); Ahn, H. (Henry); Johal, H. (Herman); H. Rijna; Stockmann, H. (Heyn); Josaputra, H.A. (Hong A.); Carlisle, H. (Hope); van der Brand, I. (Igor); I. Dawson (Imro); Tarkin, I. (Ivan); Wong, I. (Ivan); Parr, J.A. (J. Andrew); Trenholm, J.A. (J. Andrew); J.C. Goslings (Carel); Amirault, J.D. (J. David); Broderick, J.S. (J. Scott); Snellen, J.P. (Jaap P.); Zijl, J.A.C. (Jacco A.C.); Ahn, J. (Jaimo); Ficke, J. (James); Irrgang, J. (James); Powell, J. (James); Ringler, J.R. (James R.); Shaer, J. (James); Monica, J.T. (James T.); J. Biert (Jan); Bosma, J. (Jan); Brattgjerd, J.E. (Jan Egil); J.P.M. Frölke (Jan Paul); J.C. Wille (Jan); Rajakumar, J. (Janakiraman); Walker, J.E. (Jane E.); Baker, J.K. (Janell K.); Ertl, J.P. (Janos P.); de Vries, J.P.P.M. (Jean Paul P.M.); Gardeniers, J.W.M. (Jean W.M.); May, J. (Jedediah); Yach, J. (Jeff); Hidy, J.T. (Jennifer T.); Westberg, J.R. (Jerald R.); Hall, J.A. (Jeremy A.); van Mulken, J. (Jeroen); McBeth, J.C. (Jessica Cooper); Hoogendoorn, J. (Jochem); Hoffman, J.M. (Jodi M.); Cherian, J.J. (Joe Joseph); Tanksley, J.A. (John A.); Clarke-Jenssen, J. (John); Adams, J.D. (John D.); Esterhai, J. (John); Tilzey, J.F. (John F.); Murnaghan, J. (John); Ketz, J.P. (John P.); Garfi, J.S. (John S.); Schwappach, J. (John); Gorczyca, J.T. (John T.); Wyrick, J. (John); Rydinge, J. (Jonas); Foret, J.L. (Jonathan L.); Gross, J.M. (Jonathan M.); Keeve, J.P. (Jonathan P.); Meijer, J. (Joost); J.J. Scheepers (Joris J.); Baele, J. (Joseph); O'Neil, J. (Joseph); Cass, J.R. (Joseph R.); Hsu, J.R. (Joseph R.); Dumais, J. (Jules); Lee, J. (Julia); Switzer, J.A. (Julie A.); Agel, J. (Julie); Richards, J.E. (Justin E.); Langan, J.W. (Justin W.); Turckan, K. (Kahn); Pecorella, K. (Kaili); Rai, K. (Kamal); Aurang, K. (Kamran); Shively, K. (Karl); K.J.P. van Wessem; Moon, K. (Karyn); Eke, K. (Kate); Erwin, K. (Katie); Milner, K. (Katrine); K.J. Ponsen (Kees-jan); Mills, K. (Kelli); Apostle, K. (Kelly); Johnston, K. (Kelly); Trask, K. (Kelly); Strohecker, K. (Kent); Stringfellow, K. (Kenya); Kruse, K.K. (Kevin K.); Tetsworth, K. (Kevin); Mitchell, K. (Khalis); Browner, K. (Kieran); Hemlock, K. (Kim); Carcary, K. (Kimberly); Jørgen Haug, K. (Knut); Noble, K. (Krista); Robbins, K. (Kristin); Payton, K. (Krystal); Jeray, K.J. (Kyle J.); Rubino, L.J. (L. Joseph); Nastoff, L.A. (Lauren A.); Leffler, L.C. (Lauren C.); L.P. Stassen (Laurents); O'Malley, L.K. (Lawrence K.); Specht, L.M. (Lawrence M.); L. Thabane (Lehana); Geeraedts, L.M.G. (Leo M.G.); Shell, L.E. (Leslie E.); Anderson, L.K. (Linda K.); Eickhoff, L.S. (Linda S.); Lyle, L. (Lindsey); Pilling, L. (Lindsey); Buckingham, L. (Lisa); Cannada, L.K. (Lisa K.); Wild, L.M. (Lisa M.); Dulaney-Cripe, L. (Liz); L.M.S.J. Poelhekke; Govaert, L. (Lonneke); Ton, L. (Lu); Kottam, L. (Lucksy); L.P.H. Leenen (Luke); Clipper, L. (Lydia); Jackson, L.T. (Lyle T.); Hampton, L. (Lynne); de Waal Malefijt, M.C. (Maarten C.); M.P. Simons; M. van der Elst (Maarten); M.W.G.A. Bronkhorst (Maarten); Bhatia, M. (Mahesh); M.F. Swiontkowski (Marc ); Lobo, M.J. (Margaret J.); Swinton, M. (Marilyn); Pirpiris, M. (Marinis); Molund, M. (Marius); Gichuru, M. (Mark); Glazebrook, M. (Mark); Harrison, M. (Mark); Jenkins, M. (Mark); MacLeod, M. (Mark); M.R. de Vries (Mark); Butler, M.S. (Mark S.); Nousiainen, M. (Markku); van ‘t Riet, M. (Martijne); Tynan, M.C. (Martin C.); Campo, M. (Martin); M.G. Eversdijk (Martin); M.J. Heetveld (Martin); Richardson, M. (Martin); Breslin, M. (Mary); Fan, M. (Mary); Edison, M. (Matt); Napierala, M. (Matthew); Knobe, M. (Matthias); Russ, M. (Matthias); Zomar, M. (Mauri); de Brauw, M. (Maurits); Esser, M. (Max); Hurley, M. (Meghan); Peters, M.E. (Melissa E.); Lorenzo, M. (Melissa); Li, M. (Mengnai); Archdeacon, M. (Michael); Biddulph, M. (Michael); Charlton, M. (Michael); McDonald, M.D. (Michael D.); McKee, M.D. (Michael D.); Dunbar, M. (Michael); Torchia, M.E. (Michael E.); Gross, M. (Michael); Hewitt, M. (Michael); Holt, M. (Michael); Prayson, M.J. (Michael J.); M.J.R. Edwards (Michael); Beckish, M.L. (Michael L.); Brennan, M.L. (Michael L.); Dohm, M.P. (Michael P.); Kain, M.S.H. (Michael S.H.); Vogt, M. (Michelle); Yu, M. (Michelle); M.H.J. Verhofstad (Michiel); Segers, M.J.M. (Michiel J.M.); M.J.M. Segers (Michiel); Siroen, M.P.C. (Michiel P.C.); M.R. Reed (Mike); Vicente, M.R. (Milena R.); M.M.M. Bruijninckx (Milko); Trivedi, M. (Mittal); M. Bhandari (Mohit); Moore, M.M. (Molly M.); Kunz, M. (Monica); Smedsrud, M. (Morten); Palla, N. (Naveen); Jain, N. (Neeraj); Out, N.J.M. (Nico J.M.); Simunovic, N. (Nicole); Simunovic, N. (Nicole); N.W.L. Schep (Niels); Müller, O. (Oliver); Guicherit, O.R. (Onno R.); O.J.F. van Waes (Oscar); Wang, O. (Otis); P. Doornebosch (Pascal); Seuffert, P. (Patricia); Hesketh, P.J. (Patrick J.); Weinrauch, P. (Patrick); Duffy, P. (Paul); Keller, P. (Paul); Lafferty, P.M. (Paul M.); Pincus, P. (Paul); P. Tornetta III (Paul); Zalzal, P. (Paul); McKay, P. (Paula); Cole, P.A. (Peter A.); de Rooij, P.D. (Peter D.); Hull, P. (Peter); Go, P.M.N.Y.M. (Peter M.N.Y.M.); P. Patka (Peter); Siska, P. (Peter); Weingarten, P. (Peter); Kregor, P. (Philip); Stahel, P. (Philip); Stull, P. (Philip); P. Wittich (Philippe); P.A.R. Rijcke (Piet); P.P. Oprel (Pim); Devereaux, P.J. (P. J.); Zhou, Q. (Qi); Lee Murphy, R. (R.); Alosky, R. (Rachel); Clarkson, R. (Rachel); Moon, R. (Raely); Logishetty, R. (Rajanikanth); Nanda, R. (Rajesh); Sullivan, R.J. (Raymond J.); Snider, R.G. (Rebecca G.); Buckley, R.E. (Richard E.); Iorio, R. (Richard); Farrugia, R.J. (Richard J); Jenkinson, R. (Richard); Laughlin, R. (Richard); R.P.R. Groenendijk (Richard); Gurich, R.W. (Richard W.); Worman, R. (Ripley); Silvis, R. (Rob); R. Haverlag (Robert); Teasdall, R.J. (Robert J.); Korley, R. (Robert); McCormack, R. (Robert); Probe, R. (Robert); Cantu, R.V. (Robert V.); Huff, R.B. (Roger B.); R.K.J. Simmermacher; Peters, R. (Rolf); Pfeifer, R. (Roman); Liem, R. (Ronald); Wessel, R.N. (Ronald N.); Verhagen, R. (Ronald); Vuylsteke, R. (Ronald); Leighton, R. (Ross); McKercher, R. (Ross); R.W. Poolman (Rudolf); Miller, R. (Russell); Bicknell, R. (Ryan); Finnan, R. (Ryan); Khan, R.M. (Ryan M.); Mehta, S. (Samir); Vang, S. (Sandy); Singh, S. (Sanjay); Anand, S. (Sanjeev); Anderson, S.A. (Sarah A.); Dawson, S.A. (Sarah A.); Marston, S.B. (Scott B.); Porter, S.E. (Scott E.); Watson, S.T. (Scott T.); S. Festen (Sebastiaan); Lieberman, S. (Shane); Puloski, S. (Shannon); Bielby, S.A. (Shea A.); Sprague, S. (Sheila); Hess, S. (Shelley); MacDonald, S. (Shelley); Evans, S. (Simone); Bzovsky, S. (Sofia); Hasselund, S. (Sondre); Lewis, S. (Sophie); Ugland, S. (Stein); Caminiti, S. (Stephanie); Tanner, S.L. (Stephanie L.); S.M. Zielinski (Stephanie); Shepard, S. (Stephanie); Sems, S.A. (Stephen A.); Walter, S.D. (Stephen D.); Doig, S. (Stephen); Finley, S.H. (Stephen H.); Kates, S. (Stephen); Lindenbaum, S. (Stephen); Kingwell, S.P. (Stephen P.); Csongvay, S. (Steve); Papp, S. (Steve); Buijk, S.E. (Steven E.); S. Rhemrev (Steven); Hollenbeck, S.M. (Steven M.); van Gaalen, S.M. (Steven M.); Yang, S. (Steven); Weinerman, S. (Stuart); Subash, (); Lambert, S. (Sue); Liew, S. (Susan); S.A.G. Meylaerts (Sven); Blokhuis, T.J. (Taco J.); de Vries Reilingh, T.S. (Tammo S.); Lona, T. (Tarjei); Scott, T. (Taryn); Swenson, T.K. (Teresa K.); Endres, T.J. (Terrence J.); Axelrod, T. (Terry); van Egmond, T. (Teun); Pace, T.B. (Thomas B.); Kibsgård, T. (Thomas); Schaller, T.M. (Thomas M.); Ly, T.V. (Thuan V.); Miller, T.J. (Timothy J.); Weber, T. (Timothy); Le, T. (Toan); Oliver, T.M. (Todd M.); T.M. Karsten (Thomas); Borch, T. (Tor); Hoseth, T.M. (Tor Magne); Nicolaisen, T. (Tor); Ianssen, T. (Torben); Rutherford, T. (Tori); Nanney, T. (Tracy); Gervais, T. (Trevor); Stone, T. (Trevor); Schrickel, T. (Tyson); Scrabeck, T. (Tyson); Ganguly, U. (Utsav); Naumetz, V. (V.); Frizzell, V. (Valda); Wadey, V. (Veronica); Jones, V. (Vicki); Avram, V. (Victoria); Mishra, V. (Vimlesh); Yadav, V. (Vineet); Arora, V. (Vinod); Tyagi, V. (Vivek); Borsella, V. (Vivian); W.J. Willems (Jaap); Hoffman, W.H. (W. H.); Gofton, W.T. (Wade T.); Lackey, W.G. (Wesley G.); Ghent, W. (Wesley); Obremskey, W. (William); Oxner, W. (William); Cross, W.W. (William W.); Murtha, Y.M. (Yvonne M.); Murdoch, Z. (Zoe)

2017-01-01

textabstractBackground Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled

Home parenteral nutrition improves quality of life and nutritional status in patients with cancer: a French observational multicentre study.

Science.gov (United States)

Culine, S; Chambrier, C; Tadmouri, A; Senesse, P; Seys, P; Radji, A; Rotarski, M; Balian, A; Dufour, P

2014-07-01

Malnutrition is a predictor of poor outcomes in patients with cancer. Little is known about the benefit of nutritional support in these patients. The purpose of this study was to assess the impact of home parenteral nutrition (HPN) on quality of life (Qol) in cancer patients. We performed an observational prospective study to determine the impact of HPN on Qol in a population of patients with heterogeneous cancer. Physicians, patients and family members had to complete a questionnaire before HPN administration and 28 days after the course of HPN. Qol was evaluated using the self-administered questionnaire FACT-G. We included 767 patients with cancer of whom 437 ended the study. Mean patient age was 63±11.4 years and 60.5% were men. Primary gastrointestinal cancer was reported in 50% of patients and 65.3% were presenting metastases. Malnutrition was reported in 98.3%. After 28 days of HPN intake, significant improvement was observed in the Qol (49.95±5.82 vs. 48.35±5.01 at baseline, pnutrition risk index had also improved significantly. Most patients (78%) had perceived a positive impact of the HPN. A significant improvement in patient's well-being was perceived also by family members and physicians. Our data suggest that preventing and correcting malnutrition using HPN in patients with cancer might have a significant benefit on their well-being. Randomized controlled studies are required to confirm this finding.

Estudio de hiperglicemia en pacientes no críticos tratados con nutrición parenteral: incidencia y factores de riesgo

OpenAIRE

Llop, J. M.; Leiva, E.; Mateu-de Antonio, J.; Berlana, D.; Badia, M.; Casasín, T.; Miana, M.; Pons, M.; Maroto, M.; Chicharro, L.; López-Suñé, E.; Díaz-Munio, E.; Sevilla, D.; Martínez, I.; Vitales, M.

2012-01-01

Background: The objectives of our study on non-critically ill patients receiving parenteral nutrition (PN) are to assess the incidence of hyperglycemia, the risk factors associated to its development and its influence in patient's evolution. Methods: A multicentric prospective observational study was performed in 9 hospitals. Four multivariate studies were developed to study the temporal risk in the occurrence of hyperglycemia (endpoint), intensive care unit (ICU) admission, length of stay (L...

Cerebellar mutism syndrome in children with brain tumours of the posterior fossa

DEFF Research Database (Denmark)

Wibroe, Morten; Cappelen, Johan; Castor, Charlotte

2017-01-01

, the clinical course and strategies for prevention and treatment are yet to be determined.Methods: This observational, prospective, multicentre study will include 500 children with posterior fossa tumours. It opened late 2014 with participation from 20 Nordic and Baltic centres. From 2016, five British centres...... for and the clinical course of CMS - with the ultimate goal of defining strategies for prevention and treatment of this severely disabling condition....

Masquerade Syndrome of Multicentre Primary Central Nervous System Lymphoma

Directory of Open Access Journals (Sweden)

Silvana Guerriero

2011-01-01

Full Text Available Purpose. In Italy we say that the most unlucky things can happen to physicians when they get sick, despite the attention of colleagues. To confirm this rumor, we report the sad story of a surgeon with bilateral vitreitis and glaucoma unresponsive to traditional therapies. Methods/Design. Case report. Results. After one year of steroidal and immunosuppressive therapy, a vitrectomy, and a trabeculectomy for unresponsive bilateral vitreitis and glaucoma, MRI showed a multicentre primary central nervous system lymphoma, which was the underlying cause of the masquerade syndrome. Conclusions. All ophthalmologists and clinicians must be aware of masquerade syndromes, in order to avoid delays in diagnosis.

Hypercalcaemic multicentric lymphoma in a dog presenting as clitoromegaly

Directory of Open Access Journals (Sweden)

Anthony B. Zambelli

2013-12-01

Full Text Available Clitoromegaly is a clinical manifestation of various local and systemic conditions in all species. The external genitalia are a very rare site of primary or metastatic lymphoma in canines, with only one previously-reported case in a dog and only sparse reports in the medical literature. Lymphoma is also very rare in dogs less than four years of age. This account reports on a T-cell multicentric lymphoma in a 16-month-old Basset hound presented primarily for clitoromegaly. The patient survived for 68 days with cyclophosphamide-vincristine-prednisolone therapy. The causes of clitoromegaly in all species, including humans, are tabulated with references.

Quality control within the multicentre perfusion CT study of primary colorectal cancer (PROSPeCT): results of an iodine density phantom study

International Nuclear Information System (INIS)

Lewis, Maria; Honey, Ian; Goh, Vicky; Beggs, Shaun; Bridges, Andrew; Wayte, Sarah; Clewer, Philip; Davis, Anne; Foy, Trevelyan; Fuller, Karen; George, Jennifer; Higginson, Antony; Iball, Gareth; Mutch, Steve; Neil, Shellagh; Sutton, David; Rivett, Cat; Slater, Andrew; Weir, Nick

2014-01-01

To assess the cross-centre consistency of iodine enhancement, contrast-to-noise ratio and radiation dose in a multicentre perfusion CT trial of colorectal cancer. A cylindrical water phantom containing different iodine inserts was examined on seven CT models in 13 hospitals. The relationship between CT number (Hounsfield units, HU) and iodine concentration (milligrams per millilitre) was established and contrast-to-noise ratios (CNRs) calculated. Radiation doses (CTDI vol , DLP) were compared across all sites. There was a linear relationship between CT number and iodine density. Iodine enhancement varied by a factor of at most 1.10, and image noise by at most 1.5 across the study sites. At an iodine concentration of 1 mg ml -1 and 100 kV, CNRs ranged from 3.6 to 4.8 in the 220-mm phantom and from 1.4 to 1.9 in the 300-mm phantom. Doses varied by a factor of at most 2.4, but remained within study dose constraints. Iterative reconstruction algorithms did not alter iodine enhancement but resulted in reduced image noise by a factor of at most 2.2, allowing a potential dose decrease of at most 80 % compared to filtered back projection (FBP). Quality control of CT performance across centres indicates that CNR values remain relatively consistent across all sites, giving acceptable image quality within the agreed dose constraints. (orig.)

Quality control within the multicentre perfusion CT study of primary colorectal cancer (PROSPeCT): results of an iodine density phantom study

Energy Technology Data Exchange (ETDEWEB)

Lewis, Maria; Honey, Ian [Trust, Medical Physics Department, Guy' s and St. Thomas' NHS Foundation, London (United Kingdom); Goh, Vicky [King' s College London, St Thomas' Hospital, Division of Imaging Sciences and Biomedical Engineering, London (United Kingdom); Beggs, Shaun [Bradford Teaching Hospitals NHS Foundation Trust, Radiation Physics Services, Bradford (United Kingdom); Bridges, Andrew; Wayte, Sarah [Radiology Physics University Hospitals Coventry and Warwickshire NHS Trust, Coventry (United Kingdom); Clewer, Philip [Medical Physics Department, University Hospital Southampton NHS Foundation Trust, Southampton (United Kingdom); Davis, Anne [Portsmouth Hospitals NHS Trust, Medical Physics Department, Portsmouth (United Kingdom); Foy, Trevelyan [Royal Cornwall Hospital NHS Trust, Medical Physics Department, Truro (United Kingdom); Fuller, Karen [Sheffield Teaching Hospitals NHS Foundation Trust, Medical Physics Department, Sheffield (United Kingdom); George, Jennifer [University Hospital of North Staffordshire NHS Trust, Medical Physics Department, Stoke-on-Trent (United Kingdom); Higginson, Antony [Portsmouth Hospitals NHS Trust, Department of Radiology, Portsmouth (United Kingdom); Iball, Gareth [Leeds Teaching Hospitals NHS Trust, Department of Medical Physics and Engineering, Leeds (United Kingdom); Mutch, Steve [Oxford University Hospitals NHS Trust, Radiation Physics and Protection Department, Oxford (United Kingdom); Neil, Shellagh; Sutton, David [NHS Tayside, Medical Physics Department, Dundee, Scotland (United Kingdom); Rivett, Cat [Plymouth Hospitals NHS Trust, Clinical and Radiation Physics, Plymouth (United Kingdom); Slater, Andrew [Oxford University Hospitals NHS Trust, Department of Radiology, Oxford (United Kingdom); Weir, Nick [Queen' s Medical Research Institute, Clinical Research Imaging Centre, Edinburgh, Scotland (United Kingdom); Collaboration: on behalf of the PROSPeCT Investigators

2014-09-15

To assess the cross-centre consistency of iodine enhancement, contrast-to-noise ratio and radiation dose in a multicentre perfusion CT trial of colorectal cancer. A cylindrical water phantom containing different iodine inserts was examined on seven CT models in 13 hospitals. The relationship between CT number (Hounsfield units, HU) and iodine concentration (milligrams per millilitre) was established and contrast-to-noise ratios (CNRs) calculated. Radiation doses (CTDI{sub vol}, DLP) were compared across all sites. There was a linear relationship between CT number and iodine density. Iodine enhancement varied by a factor of at most 1.10, and image noise by at most 1.5 across the study sites. At an iodine concentration of 1 mg ml{sup -1} and 100 kV, CNRs ranged from 3.6 to 4.8 in the 220-mm phantom and from 1.4 to 1.9 in the 300-mm phantom. Doses varied by a factor of at most 2.4, but remained within study dose constraints. Iterative reconstruction algorithms did not alter iodine enhancement but resulted in reduced image noise by a factor of at most 2.2, allowing a potential dose decrease of at most 80 % compared to filtered back projection (FBP). Quality control of CT performance across centres indicates that CNR values remain relatively consistent across all sites, giving acceptable image quality within the agreed dose constraints. (orig.)

Standardised multicentre procedure for plasma gonadotrophin radioimmunoassay

Energy Technology Data Exchange (ETDEWEB)

Ferguson, K M; Hayes, M; Jeffcoate, S L [Chelsea Hospital for Women, London (UK)

1982-09-01

A radioimmunoassay method for the assay of luteinising hormone (LH) and follicle-stimulating hormone (FSH) in serum/plasma has been designed for use in laboratories of varying expertise in the United Kingdom. The major sources of experimental error leading to poor within-laboratory performance and between-laboratory comparability were identified: quality of tracer, use of calibration standards, and separation procedure. A simple rugged kit was designed which was extensively tested first in our laboratory and then in a small multi-centre field trial before being made available. It is now used routinely by 26 health service and research laboratories. The working range of the assays is 1-50 IU/l (LH) and 0.3-16 IU/l (FSH). The between-batch reproducibility was 5-11% (CV) over the dose range 4.8-18 IU/l (LH) and 1.6-15 IU/l (FSH).

Improved inter-observer agreement of an expert review panel in an oncology treatment trial--Insights from a structured interventional process.

Science.gov (United States)

Nestle, Ursula; Rischke, Hans Christian; Eschmann, Susanne Martina; Holl, Gabriele; Tosch, Marco; Miederer, Matthias; Plotkin, Michail; Essler, Markus; Puskas, Cornelia; Schimek-Jasch, Tanja; Duncker-Rohr, Viola; Rühl, Friederike; Leifert, Anja; Mix, Michael; Grosu, Anca-Ligia; König, Jochem; Vach, Werner

2015-11-01

Oncologic imaging is a key for successful cancer treatment. While the quality assurance (QA) of image acquisition protocols has already been focussed, QA of reading and reporting offers still room for improvement. The latter was addressed in the context of a prospective multicentre trial on fluoro-deoxyglucose (FDG)-positron-emission tomography (PET)/CT-based chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC). An expert panel was prospectively installed performing blinded reviews of mediastinal NSCLC involvement in FDG-PET/CT. Due to a high initial reporting inter-observer disagreement, the independent data monitoring committee (IDMC) triggered an interventional harmonisation process, which overall involved 11 experts uttering 6855 blinded diagnostic statements. After assessing the baseline inter-observer agreement (IOA) of a blinded re-review (phase 1), a discussion process led to improved reading criteria (phase 2). Those underwent a validation study (phase 3) and were then implemented into the study routine. After 2 months (phase 4) and 1 year (phase 5), the IOA was reassessed. The initial overall IOA was moderate (kappa 0.52 CT; 0.53 PET). After improvement of reading criteria, the kappa values improved substantially (kappa 0.61 CT; 0.66 PET), which was retained until the late reassessment (kappa 0.71 CT; 0.67 PET). Subjective uncertainty was highly predictive for low IOA. The IOA of an expert panel was significantly improved by a structured interventional harmonisation process which could be a model for future clinical trials. Furthermore, the low IOA in reporting nodal involvement in NSCLC may bear consequences for individual patient care. Copyright © 2015 Elsevier Ltd. All rights reserved.

Broadening of Generalized Anxiety Disorders Definition Does not Affect the Response to Psychiatric Care: Findings from the Observational ADAN Study

Science.gov (United States)

Álvarez, Enrique; Carrasco, Jose L; Olivares, José M; López-Gómez, Vanessa; Vilardaga, Inma; Perez, María

2012-01-01

Objective: To elucidate the consequences of broadening DSM-IV criteria for generalized anxiety disorder (GAD), we examined prospectively the evolution of GAD symptoms in two groups of patients; one group diagnosed according to DSM-IV criteria and the other, according to broader criteria. Method: Multicentre, prospective and observational study conducted on outpatient psychiatric clinics. Patients were selected from October 2007 to January 2009 and diagnosed with GAD according to DSM-IV criteria (DSM-IV group) or broader criteria. Broader criteria were considered 1-month of excessive or non-excessive worry and only 2 of the associated symptoms listed on DSM-IV for GAD diagnosis. Socio-demographic data, medical history and functional outcome measures were collected three times during a 6-month period. Results: 3,549 patients were systematically recruited; 1,815 patients in DSM-IV group (DG) and 1,264 in broad group (BG); 453 patients did not fulfil inclusion criteria and were excluded. Most patients (87.9% in DG, 82.0% in BG) were currently following pharmacological therapies (mainly benzodiazepines) to manage their anxiety symptoms. The changes observed during the study were: 49.0% and 58.0%, respectively of patients without anxiety symptoms as per HAM-A scale at the 6 month visit (p=0.261) and 59.7% and 67.7%, respectively (p=0.103) of responder rates (> 50% reduction of baseline scoring). Conclusion: Broadening of GAD criteria does not seem to affect psychiatric care results in subjects with GAD, is able to identify the core symptoms of the disease according to the DSM-IV criteria and could lead to an earlier diagnosis. PMID:23173012

The EMBARC European Bronchiectasis Registry: protocol for an international observational study

Directory of Open Access Journals (Sweden)

James D. Chalmers

2016-01-01

Full Text Available Bronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration registry is a prospective, pan-European observational study of patients with bronchiectasis. The inclusion criterion is a primary clinical diagnosis of bronchiectasis consisting of: 1 a clinical history consistent with bronchiectasis; and 2 computed tomography demonstrating bronchiectasis. Core exclusion criteria are: 1 bronchiectasis due to known cystic fibrosis; 2 age <18 years; and 3 patients who are unable or unwilling to provide informed consent. The study aims to enrol 1000 patients by April 2016 across at least 20 European countries, and 10 000 patients by March 2020. Patients will undergo a comprehensive baseline assessment and will be followed up annually for up to 5 years with the goal of providing high-quality longitudinal data on outcomes, treatment patterns and quality of life. Data from the registry will be available in the form of annual reports. and will be disseminated in conference presentations and peer-reviewed publications. The European Bronchiectasis Registry aims to make a major contribution to understanding the natural history of the disease, as well as guiding evidence-based decision making and facilitating large randomised controlled trials.

Multicentre study with activity meters launched by PTB

International Nuclear Information System (INIS)

Rodloff, G.

1992-01-01

The German Pharmacopeia tolerates for most radionuclides deviations of up to 10% from the actual activity value. The evaluation of a multicentre study launched by the PTB (Federal Physicotechnical Institute) during the period between 1982 and 1987 revealed, however, that not all producers paid attention to these tolerance limits. Occasional values were reported to differ by more than 50% or even a factor of 2 from the PTB value. In order that those deviations are kept to a minimum it is necessary for both manufacturers and users to meet the requirements of the DIN 6852 industrial standard. Activity determinations for 99 Tc m eluates must additionally be carried out in accordance with the recommendations contained in DIN 6854. (orig./DG) [de

Fracture fixation in the operative management of hip fractures (FAITH) : an international, multicentre, randomised controlled trial

NARCIS (Netherlands)

Nauth, Aaron; Creek, Aaron T.; Zellar, Abby; Lawendy, Abdel Rahman; Dowrick, Adam; Gupta, Ajay; Dadi, Akhil; van Kampen, Albert; Yee, Albert; de Vries, Alexander C.; de Mol van Otterloo, Alexander; Garibaldi, Alisha; Liew, Allen; McIntyre, Allison W.; Prasad, Amal Shankar; Romero, Amanda W.; Rangan, Amar; Oatt, Amber; Sanghavi, Amir; Foley, Amy L.; Karlsten, Anders; Dolenc, Andrea; Bucknill, Andrew; Chia, Andrew; Evans, Andrew; Gong, Andrew; Schmidt, Andrew H.; Marcantonio, Andrew J.; Jennings, Andrew; Ward, Angela; Khanna, Angshuman; Rai, Anil; Smits, Anke B; Horan, Annamarie D.; Brekke, Anne Christine; Flynn, Annette; Duraikannan, Aravin; Stødle, Are; van Vugt, Arie B.; Luther, Arlene; Zurcher, Arthur W.; Jain, Arvind; Amundsen, Asgeir; Moaveni, Ash; Carr, Ashley; Sharma, Ateet; Hill, Austin D.; Trommer, Axel; Rai, B. Sachidananda; Hileman, Barbara; Schreurs, Bart; Verhoeven, Bart A N; Barden, Benjamin B.; Flatøy, Bernhard; Cleffken, Berry I.; Bøe, Berthe; Perey, Bertrand; Hanusch, Birgit C.; Weening, Brad; Fioole, Bram; Rijbroek, Bram; Crist, Brett D.; Halliday, Brett; Peterson, Brett; Mullis, Brian; Richardson, C. Glen; Clark, Callum; Sagebien, Carlos A.; van der Pol, Carmen C.; Bowler, Carol; Humphrey, Catherine A.; Coady, Catherine; Koppert, Cees L.; Coles, Chad; Tannoury, Chadi; DePaolo, Charles J.; Gayton, Chris; Herriott, Chris; Reeves, Christina; Tieszer, Christina; Dobb, Christine; Anderson, Christopher G.; Sage, Claire; Cuento, Claudine; Jones, Clifford B.; Bosman, Coks H.R.; Linehan, Colleen; van der Hart, Cor P.; Henderson, Corey; Lewis, Courtland G.; Davis, Craig A.; Donohue, Craig; Mauffrey, Cyril; Sundaresh, D. C.; Farrell, Dana J.; Whelan, Daniel B.; Horwitz, Daniel; Stinner, Daniel; Viskontas, Darius; Roffey, Darren M.; Alexander, David; Karges, David E.; Hak, David; Johnston, David; Love, David; Wright, David M.; Zamorano, David P.; Goetz, David R.; Sanders, David; Stephen, David; Yen, David; Bardana, Davide; Olakkengil, Davy J.; Lawson, Deanna; Maddock, Deborah; Sietsema, Debra L.; Pourmand, Deeba; Den Hartog, Dennis; Donegan, Derek; Heels-Ansdell, Diane; Nam, Diane; Inman, Dominic; Boyer, Dory; Li, Doug; Gibula, Douglas; Price, Dustin M.; Watson, Dylan J.; Hammerberg, E. Mark; Tan, Edward C T H; de Graaf, Eelco J.R.; Vesterhus, Elise Berg; Roper, Elizabeth; Edwards, Elton; Schemitsch, Emil H.; Hammacher, Eric R.; Henderson, Eric R.; Whatley, Erica; Torres, Erick T.; Vermeulen, Erik G.J.; Finn, Erin; Van Lieshout, Esther M M; Wai, Eugene K.; Bannister, Evan R.; Kile, Evelyn; Theunissen, Evert B.M.; Ritchie, Ewan D.; Khan, Farah; Moola, Farhad; Howells, Fiona; de Nies, Frank; van der Heijden, Frank H.W.M.; de Meulemeester, Frank R.A.J.; Frihagen, Frede; Nilsen, Fredrik; Schmidt, G. Ben; Albers, G. H.Robert; Gudger, Garland K.; Johnson, Garth; Gruen, Gary; Zohman, Gary; Sharma, Gaurav; Wood, Gavin; Tetteroo, Geert W.M.; Hjorthaug, Geir; Jomaas, Geir; Donald, Geoff; Rieser, Geoffrey Ryan; Reardon, Gerald; Slobogean, Gerard P.; Roukema, Gert R.; Visser, Gijs A.; Moatshe, Gilbert; Horner, Gillian; Rose, Glynis; Guyatt, Gordon; Chuter, Graham; Etherington, Greg; Rocca, Gregory J.Della; Ekås, Guri; Dobbin, Gwendolyn; Lemke, H. Michael; Curry, Hamish; Boxma, Han; Gissel, Hannah; Kreder, Hans; Kuiken, Hans; Brom, Hans L.F.; Pape, Hans Christoph; van der Vis, Harm M.; Bedi, Harvinder; Vallier, Heather A.; Brien, Heather; Silva, Heather; Newman, Heike; Viveiros, Helena; van der Hoeven, Henk; Ahn, Henry; Johal, Herman; Rijna, Herman; Stockmann, Heyn; Josaputra, Hong A.; Carlisle, Hope; van der Brand, Igor; Dawson, Imro; Tarkin, Ivan; Wong, Ivan; Parr, J. Andrew; Trenholm, J. Andrew; Goslings, J Carel; Amirault, J. David; Broderick, J. Scott; Snellen, Jaap P.; Zijl, Jacco A.C.; Ahn, Jaimo; Ficke, James; Irrgang, James; Powell, James; Ringler, James R.; Shaer, James; Monica, James T.; Biert, Jan; Bosma, Jan; Brattgjerd, Jan Egil; Frölke, Jan Paul M.; Wille, Jan; Rajakumar, Janakiraman; Walker, Jane E.; Baker, Janell K.; Ertl, Janos P.; De Vries, Jean-Paul P. M.; Gardeniers, Jean W.M.; May, Jedediah; Yach, Jeff; Hidy, Jennifer T.; Westberg, Jerald R.; Hall, Jeremy A.; van Mulken, Jeroen; McBeth, Jessica Cooper; Hoogendoorn, Jochem M; Hoffman, Jodi M.; Cherian, Joe Joseph; Tanksley, John A.; Clarke-Jenssen, John; Adams, John D.; Esterhai, John; Tilzey, John F.; Murnaghan, John; Ketz, John P.; Garfi, John S.; Schwappach, John; Gorczyca, John T.; Wyrick, John; Rydinge, Jonas; Foret, Jonathan L.; Gross, Jonathan M.; Keeve, Jonathan P.; Meijer, Joost; Scheepers, Joris J.G.; Baele, Joseph; O'Neil, Joseph; Cass, Joseph R.; Hsu, Joseph R.; Dumais, Jules; Lee, Julia; Switzer, Julie A.; Agel, Julie; Richards, Justin E.; Langan, Justin W.; Turckan, Kahn; Pecorella, Kaili; Rai, Kamal; Aurang, Kamran; Shively, Karl; van Wessem, Karlijn; Moon, Karyn; Eke, Kate; Erwin, Katie; Milner, Katrine; Ponsen, Kees Jan; Mills, Kelli; Apostle, Kelly; Johnston, Kelly; Trask, Kelly; Strohecker, Kent; Stringfellow, Kenya; Kruse, Kevin K.; Tetsworth, Kevin; Mitchell, Khalis; Browner, Kieran; Hemlock, Kim; Carcary, Kimberly; Jørgen Haug, Knut; Noble, Krista; Robbins, Kristin; Payton, Krystal; Jeray, Kyle J.; Rubino, L. Joseph; Nastoff, Lauren A.; Leffler, Lauren C.; Stassen, Laurents P.S.; O'Malley, Lawrence K.; Specht, Lawrence M.; Thabane, Lehana; Geeraedts, Leo M.G.; Shell, Leslie E.; Anderson, Linda K.; Eickhoff, Linda S.; Lyle, Lindsey; Pilling, Lindsey; Buckingham, Lisa; Cannada, Lisa K.; Wild, Lisa M.; Dulaney-Cripe, Liz; Poelhekke, Lodewijk M.S.J.; Govaert, Lonneke; Ton, Lu; Kottam, Lucksy; Leenen, Luke P.H.; Clipper, Lydia; Jackson, Lyle T.; Hampton, Lynne; de Waal Malefijt, Maarten C.; Simons, Maarten P.; van der Elst, Maarten; Bronkhorst, Maarten W.G.A.; Bhatia, Mahesh; Swiontkowski, Marc; Lobo, Margaret J.; Swinton, Marilyn; Pirpiris, Marinis; Molund, Marius; Gichuru, Mark; Glazebrook, Mark; Harrison, Mark; Jenkins, Mark; MacLeod, Mark; de Vries, Mark R.; Butler, Mark S.; Nousiainen, Markku; van ‘t Riet, Martijne; Tynan, Martin C.; Campo, Martin; Eversdijk, Martin G.; Heetveld, Martin J.; Richardson, Martin; Breslin, Mary; Fan, Mary; Edison, Matt; Napierala, Matthew; Knobe, Matthias; Russ, Matthias; Zomar, Mauri; de Brauw, Maurits; Esser, Max; Hurley, Meghan; Peters, Melissa E.; Lorenzo, Melissa; Li, Mengnai; Archdeacon, Michael; Biddulph, Michael; Charlton, Michael R; McDonald, Michael D.; McKee, Michael D.; Dunbar, Michael; Torchia, Michael E.; Gross, Michael; Hewitt, Michael; Holt, Michael; Prayson, Michael J.; Edwards, Michael J R; Beckish, Michael L.; Brennan, Michael L.; Dohm, Michael P.; Kain, Michael S.H.; Vogt, Michelle; Yu, Michelle; Verhofstad, Michiel H J; Segers, Michiel J M; Segers, Michiel J M; Siroen, Michiel P.C.; Reed, Mike; Vicente, Milena R.; Bruijninckx, Milko M.M.; Trivedi, Mittal; Bhandari, Mohit; Moore, Molly M.; Kunz, Monica; Smedsrud, Morten; Palla, Naveen; Jain, Neeraj; Out, Nico J.M.; Simunovic, Nicole; Simunovic, Nicole; Schep, Niels W. L.; Müller, Oliver; Guicherit, Onno R.; Van Waes, Oscar J.F.; Wang, Otis; Doornebosch, Pascal G.; Seuffert, Patricia; Hesketh, Patrick J.; Weinrauch, Patrick; Duffy, Paul; Keller, Paul; Lafferty, Paul M.; Pincus, Paul; Tornetta, Paul; Zalzal, Paul; McKay, Paula; Cole, Peter A.; de Rooij, Peter D.; Hull, Peter; Go, Peter M.N.Y.M.; Patka, Peter; Siska, Peter; Weingarten, Peter; Kregor, Philip; Stahel, Philip; Stull, Philip; Wittich, Philippe; de Rijcke, Piet A.R.; Oprel, Pim; Devereaux, P. J.; Zhou, Qi; Lee Murphy, R.; Alosky, Rachel; Clarkson, Rachel; Moon, Raely; Logishetty, Rajanikanth; Nanda, Rajesh; Sullivan, Raymond J.; Snider, Rebecca G.; Buckley, Richard E.; Iorio, Richard; Farrugia, Richard J.; Jenkinson, Richard; Laughlin, Richard; Groenendijk, Richard P R; Gurich, Richard W.; Worman, Ripley; Silvis, Rob; Haverlag, Robert; Teasdall, Robert J.; Korley, Robert; McCormack, Robert; Probe, Robert; Cantu, Robert V.; Huff, Roger B.; Simmermacher, Rogier K J; Peters, Rolf; Pfeifer, Roman; Liem, Ronald; Wessel, Ronald N.; Verhagen, Ronald; Vuylsteke, Ronald J C L M; Leighton, Ross; McKercher, Ross; Poolman, Rudolf W; Miller, Russell; Bicknell, Ryan; Finnan, Ryan; Khan, Ryan M.; Mehta, Samir; Vang, Sandy; Singh, Sanjay; Anand, Sanjeev; Anderson, Sarah A.; Dawson, Sarah A.; Marston, Scott B.; Porter, Scott E.; Watson, Scott T.; Festen, Sebastiaan; Lieberman, Shane; Puloski, Shannon; Bielby, Shea A.; Sprague, Sheila; Hess, Shelley; MacDonald, Shelley; Evans, Simone; Bzovsky, Sofia; Hasselund, Sondre; Lewis, Sophie; Ugland, Stein; Caminiti, Stephanie; Tanner, Stephanie L.; Zielinski, Stephanie M.; Shepard, Stephanie; Sems, Stephen A.; Walter, Stephen D.; Doig, Stephen; Finley, Stephen H.; Kates, Stephen; Lindenbaum, Stephen; Kingwell, Stephen P.; Csongvay, Steve; Papp, Steve; Buijk, Steven E.; Rhemrev, Steven J.; Hollenbeck, Steven M.; van Gaalen, Steven M.; Yang, Steven; Weinerman, Stuart; Lambert, Sue; Liew, Susan; Meylaerts, Sven A.G.; Blokhuis, Taco J.; de Vries Reilingh, Tammo S.; Lona, Tarjei; Scott, Taryn; Swenson, Teresa K.; Endres, Terrence J.; Axelrod, Terry; van Egmond, Teun; Pace, Thomas B.; Kibsgård, Thomas; Schaller, Thomas M.; Ly, Thuan V.; Miller, Timothy J.; Weber, Timothy; Le, Toan; Oliver, Todd M.; Karsten, Tom M.; Borch, Tor; Hoseth, Tor Magne; Nicolaisen, Tor; Ianssen, Torben; Rutherford, Tori; Nanney, Tracy; Gervais, Trevor; Stone, Trevor; Schrickel, Tyson; Scrabeck, Tyson; Ganguly, Utsav; Naumetz, V.; Frizzell, Valda; Wadey, Veronica; Jones, Vicki; Avram, Victoria; Mishra, Vimlesh; Yadav, Vineet; Arora, Vinod; Tyagi, Vivek; Borsella, Vivian; Willems, W. Jaap; Hoffman, W. H.; Gofton, Wade T.; Lackey, Wesley G.; Ghent, Wesley; Obremskey, William; Oxner, William; Cross, William W.; Murtha, Yvonne M.; Murdoch, Zoe

2017-01-01

Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we

Previous exposure in a high-risk area for travellers' diarrhoea within the past year is associated with a significant protective effect for travellers' diarrhoea: a prospective observational cohort study in travellers to South Asia.

Science.gov (United States)

Kuenzli, Esther; Juergensen, David; Kling, Kerstin; Jaeger, Veronika K; DeCrom, Susan; Steffen, Robert; Widmer, Andreas F; Battegay, Manuel; Hatz, Christoph; Neumayr, Andreas

2017-09-01

Travellers' diarrhoea is the most common health problem in travellers. Depending on the region visited, up to 40% of travellers develop diarrhoea during a 2-week trip. The aim of this study was to assess risk factors for TD among travellers to the Indian subcontinent. An observational prospective multicentre cohort study investigated travellers to the Indian subcontinent. Participants completed questionnaires assessing the incidence of travellers' diarrhoea and identifying potential risk factors. Covariates were assessed univariately, followed by a multivariate regression. Two-hundred and twenty-six travellers were enrolled into the study, 178 filled in both pre- and post-travel questionnaires. Overall, the attack rate of travellers' diarrhoea was 38.2%. Travel destination is a key risk factor for the occurrence of TD. Travelling to India or Nepal vs Bhutan is associated with an increased risk for TD (OR 6.68 and 6.62, respectively). A length of stay of more than 3 weeks compared to less than 2 weeks is also associated with a significantly increased risk (OR 5.45). Having stayed in a high-risk area for travellers' diarrhoea within the past year before the current trip is associated with a significantly decreased risk (OR 0.19). No association was found between consumption of high risk food (i.e. tap water, ice cream, raw meat and hamburgers) and travellers' diarrhoea. Travellers' diarrhoea is a frequent problem in travellers to the Indian subcontinent. Previous exposure in a high-risk area for travellers' diarrhoea within the past year appears to have a significant protective effect. Furthermore, an association between the occurrence of travellers' diarrhoea and travel destination and length of stay, respectively, was observed. Consumption of risk food did not confer a TD risk in our study. © International Society of Travel Medicine, 2017. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Scientific knowledge and modern prospecting

Science.gov (United States)

Neuerburg, G.J.

1985-01-01

Modern prospecting is the systematic search for specified and generally ill-exposed components of the Earth's crust known as ore. This prospecting depends entirely on reliable, or scientific knowledge for guidance and for recognition of the search objects. Improvement in prospecting results from additions and refinements to scientific knowledge. Scientific knowledge is an ordered distillation of observations too numerous and too complex in themselves for easy understanding and for effective management. The ordering of these observations is accomplished by an evolutionary hierarchy of abstractions. These abstractions employ simplified descriptions consisting of characterization by selected properties, sampling to represent much larger parts of a phenomenon, generalized mappings of patterns of geometrical and numerical relations among properties, and explanation (theory) of these patterns as functional relations among the selected properties. Each abstraction is predicated on the mode of abstraction anticipated for the next higher level, so that research is a deductive process in which the highest level, theory, is indispensible for the growth and refinement of scientific knowledge, and therefore of prospecting methodology. ?? 1985 Springer-Verlag.

Metabolic Abnormalities Detected in Phase II Evaluation of Doxycycline in Dogs with Multicentric B-Cell Lymphoma

Directory of Open Access Journals (Sweden)

Kelly R. Hume

2018-02-01

Full Text Available Doxycycline has antiproliferative effects in human lymphoma cells and in murine xenografts. We hypothesized that doxycycline would decrease canine lymphoma cell viability and prospectively evaluated its clinical tolerability in client-owned dogs with spontaneous, nodal, multicentric, substage a, B-cell lymphoma, not previously treated with chemotherapy. Treatment duration ranged from 1 to 8 weeks (median and mean, 3 weeks. Dogs were treated with either 10 (n = 6 or 7.5 (n = 7 mg/kg by mouth twice daily. One dog had a stable disease for 6 weeks. No complete or partial tumor responses were observed. Five dogs developed grade 3 and/or 4 metabolic abnormalities suggestive of hepatopathy with elevations in bilirubin, ALT, ALP, and/or AST. To evaluate the absorption of oral doxycycline in our study population, serum concentrations in 10 treated dogs were determined using liquid chromatography tandem mass spectrometry. Serum levels were variable and ranged from 3.6 to 16.6 µg/ml (median, 7.6 µg/ml; mean, 8.8 µg/ml. To evaluate the effect of doxycycline on canine lymphoma cell viability in vitro, trypan blue exclusion assay was performed on canine B-cell lymphoma cell lines (17-71 and CLBL and primary B-cell lymphoma cells from the nodal tissue of four dogs. A doxycycline concentration of 6 µg/ml decreased canine lymphoma cell viability by 80%, compared to matched, untreated, control cells (mixed model analysis, p < 0.0001; Wilcoxon signed rank test, p = 0.0313. Although the short-term administration of oral doxycycline is not associated with the remission of canine lymphoma, combination therapy may be worthwhile if future research determines that doxycycline can alter cell survival pathways in canine lymphoma cells. Due to the potential for metabolic abnormalities, close monitoring is recommended with the use of this drug in tumor-bearing dogs. Additional research is needed to assess the tolerability of chronic

ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial

Directory of Open Access Journals (Sweden)

Schlitt Hans

2010-04-01

Full Text Available Abstract Background A recently published systematic review indicated superiority of duodenum-preserving techniques when compared with pancreatoduodenectomy, for the treatment of patients with chronic pancreatitis in the head of the gland. A multicentre randomised trial to confirm these results is needed. Methods/Design ChroPac aims to investigate differences in quality of life, mortality and morbidity during 24 months after surgery (duodenum-preserving pancreatic head resection versus pancreatoduodenectomy in patients with chronic pancreatitis of the pancreatic head. ChroPac is a randomised, controlled, observer and patient blinded multicentre surgical trial with two parallel comparison groups. The primary outcome measure will be the average quality of life during 24 months after surgery. Statistical analysis is based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison adjusting for age, centre and quality of life before surgery. Level of significance is set at 5% (two-sided and sample size (n = 100 per group is determined to assure a power of 90%. Discussion The ChroPac trial will explore important outcomes from different perspectives (e.g. surgeon, patient, health care system. Its pragmatic approach promises high external validity allowing a comprehensive evaluation of the surgical strategy for treatment of patients with chronic pancreatitis. Trial registration Controlled-trials.com ISRCTN38973832

Advantages of the modified double ring areolar incision over the traditional areolar incision in multicentric breast fibroadenoma surgery.

Science.gov (United States)

Zhang, Mingliang; Shen, Gongjin; Zhang, Song; Cui, Zhen; Qian, Jun

2017-09-01

This study was conducted to investigate the clinical advantages of modified double ring areola incision (MDRAI) compared to ordinary areola incision (OAI) in multicentric breast fibroadenoma in women. Sixty cases of multicentric benign breast tumor were recruited from the First Affiliated Hospital of Bengbu Medical College from January to December 2016. The cases were divided into two groups according to surgical approach: MDRAI (n = 20) and OAI (n = 40). The operation duration, intraoperative blood loss, drainage time, and postoperative recurrence rate in the first six months were compared. The mean age and tumor locations were not statistically different between the groups (P > 0.05). However, more lesions and larger tumor diameter were found in the MDRAI group than in the OAI group, with statistical difference (P  0.05). However, the intraoperative blood loss was statistically different between the two groups (P < 0.05). All 60 cases received six months of follow-up. Eight recurrent cases were found in the OAI group, but none in the MDRAI group. The recurrence rate was significantly different (χ 2  = 4.62, P < 0.05). Compared with OAI, MDRAI offers greater advantages in the aspects of blood loss and recurrence for the treatment of breast benign tumor, especially for multicentric larger lesions. © 2017 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

Case report 446: Multicentric, metachronous, low-grade, sclerosing osteogenic sarcoma

International Nuclear Information System (INIS)

McCarthy, E.F.; Tolo, V.T.; Dorfman, H.D.

1987-01-01

This case of multicentric osteosarcoma has overlying features of the clinical subgroups described by Amstutz and Mahoney. This 38-year-old woman has survived 6 years with metachronous multifocal osteosarcomas. She presently has at least seven sites of involvement. The lesions are all densely sclerotic and are confined to the axial skeleton. She has had no treatment except for release of compression syndromes. She has no evidence of pulmonary or other visceral metastases. The low grade nature of this type of multifocal osteosarcoma is confirmed by a six year survival in the absence of ablative surgery, radiotherapy or chemotherapy. (orig.)

Preperimetric Glaucoma Prospective Observational Study (PPGPS: Design, baseline characteristics, and therapeutic effect of tafluprost in preperimetric glaucoma eye.

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Naoko Aizawa

Full Text Available There is no consensus on the diagnosis or treatment policy for Preperimetric Glaucoma (PPG because the pathogenesis of PPG is not clear at this time. Preperimetric Glaucoma Prospective Observational Study (PPGPS is a first multicenter, prospective, observational study to clarify the pathogenesis of PPG. This article indicates study design, patient baseline characteristics, and analysis focused on optic nerve head (ONH blood flow in PPG, as well as the intraocular pressure (IOP -lowering effect and ONH blood flow-improving effects of Tafluprost.In this study, 122 eyes from 122 subjects (mean age: 53.1 ± 14.3 newly diagnosed as PPG were enrolled. The circumpapillary retinal nerve fiber layer thickness (cpRNFLT was evaluated with optical coherence tomography (OCT. The ONH blood flow was measured with laser speckle flowgraphy. The therapeutic effect of Tafluprost was evaluated at Month 0 (ONH blood flow-improving effect and Month 4 (IOP-lowering effect.The untreated IOP, cpRNFLT, and baseline Mean deviation (MD value was 16.4 ± 2.5 mmHg, 80.4 ± 8.2 μm, and -0.48 ± 1.29 dB, respectively. In the site-specific visual field evaluation using the sector map, there was no appreciable site-specific visual field defect in the eye with PPG. The inferior region of cpRNFLT in 4-quadrant OCT sector analysis and 6 o'clock region in 12-o'clock OCT sector analysis was the highest rate of abnormality in PPG eyes. Topical administration of Tafluprost significantly reduced IOP from 16.4 ± 2.5 mmHg at baseline to 14.5 ± 2.3 mmHg at Month 4 (P < 0.001, paired t-test. In the linear regression analysis, there was a significant relationship between the increase of ONH blood flow and baseline value.PPGPS is a first prospective study focusing on the pathology of PPG. This study is expected to elucidate the pathology of PPG, with evidence useful for determining a treatment strategy for PPG.

Daily variations in air pollution and respiratory health in a multicentre study: the PEACE project.

NARCIS (Netherlands)

Roemer, W.; Hoek, G.; Brunekreef, B.; Haluszka, J.; Kalandidi, A.; Pekkanen, J.

1998-01-01

The Pollution Effects on Asthmatic Children in Europe (PEACE) study is a multicentre study of the acute effects of particles with a 50% cut-off aerodynamic diameter of 10 μm (PM10), black smoke (BS), sulphur dioxide (SO2) and nitrogen dioxide (NO2) on the respiratory health of children with chronic

Dosimetry audit for a multi-centre IMRT head and neck trial

International Nuclear Information System (INIS)

Clark, Catharine H.; Hansen, Vibeke Nordmark; Chantler, Hannah; Edwards, Craig; James, Hayley V.; Webster, Gareth; Miles, Elizabeth A.; Guerrero Urbano, M. Teresa; Bhide, Shree A.; Bidmead, A. Margaret; Nutting, Christoper M.

2009-01-01

Background and purpose: PARSPORT was a multi-centre randomised trial in the UK which compared Intensity-Modulated Radiotherapy (IMRT) and conventional radiotherapy (CRT) for patients with head and neck cancer. The dosimetry audit goals were to verify the plan delivery in participating centres, ascertain what tolerances were suitable for head and neck IMRT trials and develop an IMRT credentialing program. Materials and methods: Centres enrolling patients underwent rigorous quality assurance before joining the trial. Following this each centre was visited for a dosimetry audit, which consisted of treatment planning system tests, fluence verification films, combined field films and dose point measurements. Results: Mean dose point measurements were made at six centres. For the primary planning target volume (PTV) the differences with the planned values for the IMRT and CRT arms were -0.6% (1.8% to -2.4%) and 0.7% (2.0% to -0.9%), respectively. Ninety-four percent of the IMRT fluence films for individual fields passed gamma criterion of 3%/3 mm and 75% of the films for combined fields passed gamma criterion 4%/3 mm (no significant difference between dynamic delivery and step and shoot delivery). Conclusions: This audit suggests that a 3% tolerance could be applied for PTV point doses. For dose distributions tolerances of 3%/3 mm on individual fields and 4%/3 mm for combined fields are proposed for multi-centre head and neck IMRT trials.

A multi-centre dosimetry audit on advanced radiotherapy in lung as part of the Isotoxic IMRT study

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Yat Tsang

2017-10-01

Conclusion: This multi-centre dosimetry audit of complex IMRT/VMAT delivery provides confidence in the accuracy of modern planning and delivery systems in inhomogeneous tissues. The findings from this study can be used as a reference for future dosimetry audits.

A multicentre study to improve clinical interpretation of proteinase-3 and myeloperoxidase anti-neutrophil cytoplasmic antibodies

DEFF Research Database (Denmark)

Bossuyt, Xavier; Rasmussen, Niels; van Paassen, Pieter

2017-01-01

Objective: The objective of this multicentre study was to improve the clinical interpretation of PR3- and MPO-ANCAs as an adjunct for the diagnosis of ANCA-associated vasculitis (AAV) by defining thresholds and test result intervals based on predefined specificities and by calculating test result...

The foundation of NCVD PCI Registry: the Malaysia's first multi-centre interventional cardiology project.

Science.gov (United States)

Liew, H B; Rosli, M A; Wan Azman, W A; Robaayah, Z; Sim, K H

2008-09-01

The National Cardiovascular Database for Percutaneous Coronary Intervention (NCVD PCI) Registry is the first multicentre interventional cardiology project, involving the main cardiac centres in the country. The ultimate goal of NCVD PCI is to provide a contemporary appraisal of PCI in Malaysia. This article introduces the foundation, the aims, methodology, database collection and preliminary results of the first six-month database.

Homoeopathic management of Schizophrenia: A prospective, non-comparative, open-label observational study

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Praveen Oberai

2016-01-01

Full Text Available Objectives: To evaluate the usefulness of homoeopathic intervention in Schizophrenia, in untreated cases and antipsychotic treatment resistant cases, to verify indications of medicines, and to assess relapse, if any. Materials and Methods: A prospective, non-comparative, open-label observational study was carried out from October 2005-September 2010 by CCRH at Central Research Institute (H, Kottayam, Kerala, India. Patients between 20 and 60 years of age, presenting with symptoms of Schizophrenia were screened for inclusion and exclusion criteria. The patients who were on antipsychotic drugs were allowed to continue the same along with homoeopathic medicine, the dose of antipsychotics was monitored by the Psychiatrist. The symptoms of each patient were repertorized, and medicine was initially prescribed in 30C potency after consulting Materia Medica. Patients were followed up for 12 months. Outcome of treatment was assessed with Brief Psychiatric Rating Scales (BPRS. Analysis was done using Statistical Package for the Social Sciences  SPSS Version 20.0. Results: Out of 188 enrolled patients, 17 cases did not complete the baseline information. Total 171 patients were analysed as per modified Intention to Treat Principle. Significant difference (P = 0.0001, P < 0.05 in the mean scores of BPRS, using paired t test was observed at end of the study. Sulphur, Lycopodium, Natrum muriaticum, Pulsatilla and Phosphorus were found to be the most useful medicines in treating schizophrenic patients. Conclusion: The study reflects the positive role of homoeopathic medicines in the management of patients suffering from schizophrenia as measured by BPRS.

Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective: a prospective, observational cohort study in the Netherlands

NARCIS (Netherlands)

Jong, L.A.W.; Harmark, L.; Puijenbroek, E. van

2016-01-01

PURPOSE: The aim of this study was to gather information about frequency, latency time, outcome and management of frequently occurring adverse drug reactions (ADRs) related to the use of metformin in daily practice. METHODS: A prospective, observational cohort study was performed. A total of 2490

In infectious endocarditis patients mortality is highly related to kidney function at time of diagnosis: a prospective observational cohort study of 231 cases

DEFF Research Database (Denmark)

Buchholtz, Kristine; Larsen, Carsten T; Hassager, Christian

2009-01-01

function at the time of admittance. METHODS: In a prospective observational cohort study data from 235 consecutive IE patients were collected at 2 tertiary heart centres in Copenhagen. Kidney function was evaluated as Estimated Endogenous Creatinine Clearance (EECC) calculated at the time of admission...

Time course, outcome and management of adverse drug reactions associated with metformin from patient's perspective : a prospective, observational cohort study in the Netherlands

NARCIS (Netherlands)

de Jong, Loek; Härmark, Linda; van Puijenbroek, Eugène

2016-01-01

PURPOSE: The aim of this study was to gather information about frequency, latency time, outcome and management of frequently occurring adverse drug reactions (ADRs) related to the use of metformin in daily practice. METHODS: A prospective, observational cohort study was performed. A total of 2490

Distribution of causes of maternal mortality during delivery and post-partum: results of an African multicentre hospital-based study.

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Thonneau, Patrick F; Matsudai, Tomohiro; Alihonou, Eusèbe; De Souza, Jose; Faye, Ousseynou; Moreau, Jean-Charles; Djanhan, Yao; Welffens-Ekra, Christiane; Goyaux, Nathalie

2004-06-15

To assess the maternal mortality ratio in maternity units of reference hospitals in large west African cities, and to describe the distribution of complications and causes of maternal deaths. Prospective descriptive study in twelve reference maternities located in three African countries (Benin, Ivory Coast, Senegal). Data (clinical findings at hospital entry, medical history, complications, type of surgery, vital status of the women at discharge) were collected from obstetrical and surgical files and from admission hospital registers. All cases of maternal deaths were systematically reviewed by African and European staff. Of a total of 10,515 women, 1495 presented a major obstetric complication with dystocia or inappropriate management of the labour phase as the leading cause. Eighty-five maternal deaths were reported, giving a global hospital-based maternal mortality ratio of 800/100,000. Hypertensive disorders were involved in 25/85 cases (29%) and post-partum haemorrhage in 13/85 cases (15%). Relatively few cases (14) of major sepsis were reported, leading to three maternal deaths. The results of this multicentre study confirm the high rates of maternal mortality in maternity units of reference hospitals in large African cities, and in addition to dystocia the contribution of hypertensive disorders and post-partum haemorrhage to maternal deaths.

MRI in multiple sclerosis: an intra-individual, randomized and multicentric comparison of gadobutrol with gadoterate meglumine at 3 T

Energy Technology Data Exchange (ETDEWEB)

Saake, Marc; Weibart, Marina; Doerfler, Arnd [University of Erlangen-Nuremberg, Department of Neuroradiology, Erlangen (Germany); Langner, Soenke; Hosten, Norbert [University Medicine Greifswald, Institute for Diagnostic Radiology and Neuroradiology, Greifswald (Germany); Schwenke, Carsten [SCO:SSiS, Statistical Consulting, Berlin (Germany); Jansen, Olav [University of Kiel, Department of Radiology and Neuroradiology, Kiel (Germany)

2016-03-15

To compare contrast effects of gadobutrol with gadoterate meglumine for brain MRI in multiple sclerosis (MS) in a multicentre, randomized, prospective, intraindividual study at 3 T. Institutional review board approval was obtained. Patients with known or suspected active MS lesions were included. Two identical MRIs were performed using randomized contrast agent order. Four post-contrast T1 sequences were acquired (start time points 0, 3, 6 and 9 min). If no enhancing lesion was present in first MRI, second MRI was cancelled. Quantitative (number and signal intensity of enhancing lesions) and qualitative parameters (time points of first and all lesions enhancing; subjective preference regarding contrast enhancement and lesion delineation; global preference) were evaluated blinded. Seventy-four patients (male, 26; mean age, 35 years) were enrolled in three centres. In 45 patients enhancing lesions were found. Number of enhancing lesions increased over time for both contrast agents without significant difference (median 2 for both). Lesions signal intensity was significantly higher for gadobutrol (p < 0.05 at time points 3, 6 and 9 min). Subjective preference rating showed non-significant tendency in favour of gadobutrol. Both gadobutrol and gadoterate meglumine can be used for imaging of acute inflammatory MS lesions. However, gadobutrol generates higher lesion SI. (orig.)

Protocol for a multicentre, multistage, prospective study in China using system-based approaches for consistent improvement in surgical safety.

Science.gov (United States)

Yu, Xiaochu; Jiang, Jingmei; Liu, Changwei; Shen, Keng; Wang, Zixing; Han, Wei; Liu, Xingrong; Lin, Guole; Zhang, Ye; Zhang, Ying; Ma, Yufen; Bo, Haixin; Zhao, Yupei

2017-06-15

Surgical safety has emerged as a crucial global health issue in the past two decades. Although several safety-enhancing tools are available, the pace of large-scale improvement remains slow, especially in developing countries such as China. The present project (Modern Surgery and Anesthesia Safety Management System Construction and Promotion) aims to develop and validate system-based integrated approaches for reducing perioperative deaths and complications using a multicentre, multistage design. The project involves collection of clinical and outcome information for 1 20 000 surgical inpatients at four regionally representative academic/teaching general hospitals in China during three sequential stages: preparation and development, effectiveness validation and improvement of implementation for promotion. These big data will provide the evidence base for the formulation, validation and improvement processes of a system-based stratified safety intervention package covering the entire surgical pathway. Attention will be directed to managing inherent patient risks and regulating medical safety behaviour. Information technology will facilitate data collection and intervention implementation, provide supervision mechanisms and guarantee transfer of key patient safety messages between departments and personnel. Changes in rates of deaths, surgical complications during hospitalisation, length of stay, system adoption and implementation rates will be analysed to evaluate effectiveness and efficiency. This study was approved by the institutional review boards of Peking Union Medical College Hospital, First Hospital of China Medical University, Qinghai Provincial People's Hospital, Xiangya Hospital Central South University and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences. Study findings will be disseminated via peer-reviewed journals, conference presentations and patent papers. © Article author(s) (or their employer(s) unless otherwise

Physical activity, body mass index and bone mineral density-associations in a prospective population-based cohort of women and men: the Canadian Multicentre Osteoporosis Study (CaMos).

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Langsetmo, L; Hitchcock, C L; Kingwell, E J; Davison, K S; Berger, C; Forsmo, S; Zhou, W; Kreiger, N; Prior, J C

2012-01-01

Physical activity (PA) is an important modifiable risk factor for both bone mineral density (BMD) and body mass index (BMI). However, BMI is itself strongly predictive of BMD. Our aim was to determine the association between PA and BMD, with consideration of BMI as a potential mediating factor. The Canadian Multicentre Osteoporosis Study (CaMos) is a population-based prospective cohort study of Canadian women and men. PA was determined from interviewer-administered questionnaires at baseline and Year 5 and summarized as daily energy expenditure in total metabolic equivalents of the task multiplied by minutes/day (MET*m/d). Height, weight, and total hip and lumbar spine BMD were measured at baseline and Year 5. General linear models assessed relationships between PA and BMD, both cross-sectionally (baseline PA with baseline BMD) and longitudinally (average PA and change in PA with change in BMD). BMI was considered as a mediating factor. Potential confounders included age, center, education, caffeine intake, alcohol exposure, smoking history, history of weight-cycling, age at menarche, past use of oral contraceptives, history of >3 months missed menstruation, menopausal status, and antiresorptive use, as relevant. The study included 2855 men and 6442 women. PA was inversely associated with BMI at baseline, and an increase in PA between baseline and Year 5 was associated with a decrease in BMI, with 0.41 (95% CI: 0.22, 0.60) kg/m(2) loss per 1000 MET*m/d increase (in men) and 0.40 (95% CI: 0.23, 0.57) kg/m(2) loss per 1000 MET*m/d increase (in women). BMI was strongly associated with BMD, both cross-sectionally and longitudinally. However, increased PA was associated with a small increase in total hip BMD, 0.004 (95% CI: 0.000-0.008) g/cm(2) per 1000 MET*m/d (in men) and 0.003 (95% CI: 0.000-0.007) g/cm(2) per 1000 MET*m/d (in women). Average PA was associated with an increase in lumbar spine BMD in women, but not in men; it was not associated with change in total

Physical Activity, Body Mass Index and Bone Mineral Density— Associations in a Prospective Population-based Cohort of Women and Men: The Canadian Multicentre Osteoporosis Study (CaMos)

Science.gov (United States)

Langsetmo, L; Hitchcock, CL; Kingwell, EJ; Davison, KS; Berger, C; Forsmo, S.; Zhou, W; Kreiger, N; Prior, JC

2013-01-01

Background Physical activity (PA) is an important modifiable risk factor for both bone mineral density (BMD) and body mass index (BMI). However, BMI is itself strongly predictive of BMD. Our aim was to determine the association between PA and BMD, with consideration of BMI as a potential mediating factor. Methods The Canadian Multicentre Osteoporosis Study (CaMos) is a population-based prospective cohort study of Canadian women and men. PA was determined from interviewer-administered questionnaires at baseline and Year 5 and summarized as daily energy expenditure in total metabolic equivalents of the task multiplied by minutes/day (MET*m/d). Height, weight, and total hip and lumbar spine BMD were measured at baseline and Year 5. General linear models assessed relationships between PA and BMD, both cross-sectionally (baseline PA with baseline BMD) and longitudinally (average PA and change in PA with change in BMD). BMI was considered as a mediating factor. Potential confounders included age, center, education, caffeine intake, alcohol exposure, smoking history, history of weight-cycling, age at menarche, past use of oral contraceptives, history of >3 months missed menstruation, menopausal status, and antiresorptive use, as relevant. Results The study included 2855 men and 6442 women. PA was inversely associated with BMI at baseline, and an increase in PA between baseline and Year 5 was associated with a decrease in BMI, with 0.41 (95% CI: 0.22, 0.60) kg/m2 loss per 1000 MET*m/d increase (in men) and 0.40 (95% CI: 0.23, 0.57) kg/m2 loss per 1000 MET*m/d increase (in women). BMI was strongly associated with BMD, both cross-sectionally and longitudinally. However, increased PA was associated with a small increase in total hip BMD, 0.004 (95% CI: 0.000–0.008) g/cm2 per 1000 MET*m/d (in men) and 0.003 (95% CI: 0.000–0.007) g/cm2 per 1000 MET*m/d (in women). Average PA was associated with an increase in lumbar spine BMD in women, but not in men; it was not associated

40 CFR 26.405 - Observational research involving greater than minimal risk but presenting the prospect of direct...

Science.gov (United States)

2010-07-01

... greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. 26.405... but presenting the prospect of direct benefit to the individual subjects. If the IRB finds that an...: (a) The intervention or procedure holds out the prospect of direct benefit to the individual subject...

Alcohol consumption and risk of type 2 diabetes in European men and women: influence of beverage type and body size. The EPIC-InterAct study

NARCIS (Netherlands)

The InterAct Consortium, A.; Feskens, E.J.M.

2012-01-01

Objective: To investigate the association between alcohol consumption and type 2 diabetes, and determine whether this is modified by sex, body mass index (BMI) and beverage type. Design: Multicentre prospective case–cohort study. Setting: Eight countries from the European Prospective Investigation

Surfactant Need by Gestation for Very Preterm Babies Initiated on Early Nasal CPAP: A Danish Observational Multicentre Study of 6,628 Infants Born 2000-2013.

Science.gov (United States)

Wiingreen, Rikke; Greisen, Gorm; Ebbesen, Finn; Petersen, Jesper Padkær; Zachariassen, Gitte; Henriksen, Tine Brink; Mølholm Hansen, Bo

2017-01-01

In recent years, early nasal continuous positive airway pressure (nCPAP) as respiratory support for preterm infants is being advocated as an alternative to prophylactic surfactant and treatment with mechanical ventilation. A number of infants treated with early nCPAP do not need treatment with surfactant, but few studies provide data on this. Since the 1990s, the first approach to respiratory support to preterm infants in Denmark has been early nCPAP combined with surfactant administration by the INSURE method by which the infant is intubated and surfactant administration is followed by rapid extubation to nCPAP if possible. To investigate how often surfactant was administered in preterm infants with a gestational age below 34 weeks treated with early nCPAP as a first approach to respiratory support. An observational multicentre study including all inborn infants with a gestational age below 34 weeks admitted to 1 of the 4 level 3 neonatal intensive care units in Denmark in the period from 2000 to 2013. A total of 6,628 infants were included in this study. We found that surfactant was administered in 1,056 of 1,799 (59%; 95% CI: 57-61%), in 821 of 2,864 (29%; 95% CI: 27-31%), and in 132 of 1,796 (7%; 95% CI: 6-8%) of the infants with a gestational age from 24 to 27, 28 to 31, and 32 to 33 weeks and 6 days, respectively. A large proportion of preterm infants treated with early nCPAP as the first approach to respiratory support was never treated with surfactant. © 2017 S. Karger AG, Basel.

A multicentre ‘end to end’ dosimetry audit for cervix HDR brachytherapy treatment

International Nuclear Information System (INIS)

Palmer, Antony L.; Diez, Patricia; Gandon, Laura; Wynn-Jones, Andrea; Bownes, Peter; Lee, Chris; Aird, Edwin; Bidmead, Margaret; Lowe, Gerry; Bradley, David; Nisbet, Andrew

2015-01-01

Purpose: To undertake the first multicentre fully ‘end to end’ dosimetry audit for HDR cervix brachytherapy, comparing planned and delivered dose distributions around clinical treatment applicators, with review of local procedures. Materials and methods: A film-dosimetry audit was performed at 46 centres, including imaging, applicator reconstruction, treatment planning and delivery. Film dose maps were calculated using triple-channel dosimetry and compared to RTDose data from treatment planning systems. Deviations between plan and measurement were quantified at prescription Point A and using gamma analysis. Local procedures were also discussed. Results: The mean difference between planned and measured dose at Point A was −0.6% for plastic applicators and −3.0% for metal applicators, at standard uncertainty 3.0% (k = 1). Isodose distributions agreed within 1 mm over a dose range 2–16 Gy. Mean gamma passing rates exceeded 97% for plastic and metal applicators at 3% (local) 2 mm criteria. Two errors were found: one dose normalisation error and one applicator library misaligned with the imaged applicator. Suggestions for quality improvement were also made. Conclusions: The concept of ‘end to end’ dosimetry audit for HDR brachytherapy has been successfully implemented in a multicentre environment, providing evidence that a high level of accuracy in brachytherapy dosimetry can be achieved

Profiling sirolimus-induced inflammatory syndrome: a prospective tricentric observational study.

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Fanny Buron

Full Text Available BACKGROUND: The use of the immunosuppressant sirolimus in kidney transplantation has been made problematic by the frequent occurrence of various side effects, including paradoxical inflammatory manifestations, the pathophysiology of which has remained elusive. METHODS: 30 kidney transplant recipients that required a switch from calcineurin inhibitor to sirolimus-based immunosuppression, were prospectively followed for 3 months. Inflammatory symptoms were quantified by the patients using visual analogue scales and serum samples were collected before, 15, 30, and 90 days after the switch. RESULTS: 66% of patients reported at least 1 inflammatory symptom, cutaneo-mucosal manifestations being the most frequent. Inflammatory symptoms were characterized by their lability and stochastic nature, each patient exhibiting a unique clinical presentation. The biochemical profile was more uniform with a drop of hemoglobin and a concomitant rise of inflammatory acute phase proteins, which peaked in the serum 1 month after the switch. Analyzing the impact of sirolimus introduction on cytokine microenvironment, we observed an increase of IL6 and TNFα without compensation of the negative feedback loops dependent on IL10 and soluble TNF receptors. IL6 and TNFα changes correlated with the intensity of biochemical and clinical inflammatory manifestations in a linear regression model. CONCLUSIONS: Sirolimus triggers a destabilization of the inflammatory cytokine balance in transplanted patients that promotes a paradoxical inflammatory response with mild stochastic clinical symptoms in the weeks following drug introduction. This pathophysiologic mechanism unifies the various individual inflammatory side effects recurrently reported with sirolimus suggesting that they should be considered as a single syndromic entity.

Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study.

Science.gov (United States)

Timmermann, Lars; Jain, Roshini; Chen, Lilly; Maarouf, Mohamed; Barbe, Michael T; Allert, Niels; Brücke, Thomas; Kaiser, Iris; Beirer, Sebastian; Sejio, Fernando; Suarez, Esther; Lozano, Beatriz; Haegelen, Claire; Vérin, Marc; Porta, Mauro; Servello, Domenico; Gill, Steven; Whone, Alan; Van Dyck, Nic; Alesch, Francois

2015-07-01

High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease. We did a prospective, multicentre, non-randomised, open-label intervention study of an implantable DBS device (the VANTAGE study) at six specialist DBS centres at universities in six European countries. Patients were judged eligible if they were aged 21-75 years, had been diagnosed with bilateral idiopathic Parkinson's disease with motor symptoms for more than 5 years, had a Hoehn and Yahr score of 2 or greater, and had a Unified Parkinson's disease rating scale part III (UPDRS III) score in the medication-off state of more than 30, which improved by 33% or more after a levodopa challenge. Participants underwent bilateral implantation in the subthalamic nucleus of a multiple-source, constant-current, eight-contact, rechargeable DBS system, and were assessed 12, 26, and 52 weeks after implantation. The primary endpoint was the mean change in UPDRS III scores (assessed by site investigators who were aware of the treatment assignment) from baseline (medication-off state) to 26 weeks after first lead implantation (stimulation-on, medication-off state). This study is registered with ClinicalTrials.gov, number NCT01221948. Of 53 patients enrolled in the study, 40 received a bilateral implant in the subthalamic nucleus and their data contributed to the primary endpoint analysis. Improvement was noted in the UPDRS III motor score 6 months after first lead implantation (mean 13·5 [SD 6·8], 95% CI 11·3-15·7) compared with baseline (37·4 [8·9], 34·5-40·2), with a mean difference of 23·8 (SD 10·6; 95% CI 20·3-27·3; p<0·0001). One patient died of pneumonia 24 weeks after implantation, which was judged to be unrelated to the procedure

A prospective observational study of skin to subarachnoid space depth in the Indian population

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Smita Prakash

2014-01-01

Full Text Available Background and Aims: A pre-puncture estimate of skin to subarachnoid space depth (SSD may guide spinal needle placement and reduce complications associated with lumbar puncture. Our aim was to determine (1 The SSD in Indian males, females, parturients and the overall population; (2 To derive formulae for predicting SSD and (3 To determine which previously suggested formula best suited our population. Methods: In this prospective, observational study, 800 adult Indian patients undergoing surgery under spinal anaesthesia were divided into three groups: Males (Group M, females (Group F and parturients (Group PF. SSD was measured after lumbar puncture. The relationship between SSD and patient characteristics was studied and statistical models were used to derive formula for predicting SSD. Statistical analysis included One-way ANOVA with post hoc analysis, forward stepwise multivariate regression analysis and paired t-tests. Results: Mean SSD was 4.71 ± 0.70 cm in the overall population. SSD in adult males (4.81 ± 0.68 cm was significantly longer than that observed in females (4.55 ± 0.66 cm but was comparable with SSD in parturients (4.73 ± 0.73 cm. Formula for predicting SSD in the overall population was 2.71 + 0.09 × Body Mass Index (BMI. Stocker′s formula when applied correlated best with the observed SSD. Formulae were derived for the three groups. Conclusions: We found gender-based differences in SSD, with SSD in males being significantly greater than that observed in the female population. SSD correlated with BMI in the parturient and the overall population. Amongst the previously proposed formulae, Stocker′s formula was most accurate in predicting SSD in our population.

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder--study protocol of the randomised, multi-centre controlled SOSTA--net trial.

Science.gov (United States)

Freitag, Christine M; Cholemkery, Hannah; Elsuni, Leyla; Kroeger, Anne K; Bender, Stephan; Kunz, Cornelia Ursula; Kieser, Meinhard

2013-01-07

Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA-FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. The SOSTA - net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. ISRCTN94863788--SOSTA--net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

The survival time of chocolates on hospital wards: covert observational study.

Science.gov (United States)

Gajendragadkar, Parag R; Moualed, Daniel J; Nicolson, Phillip L R; Adjei, Felicia D; Cakebread, Holly E; Duehmke, Rudolf M; Martin, Claire A

2013-12-14

To quantify the consumption of chocolates in a hospital ward environment. Multicentre, prospective, covert observational study. Four wards at three hospitals (where the authors worked) within the United Kingdom. Boxes of Quality Street (Nestlé) and Roses (Cadbury) on the ward and anyone eating these chocolates. Observers covertly placed two 350 g boxes of Quality Street and Roses chocolates on each ward (eight boxes were used in the study containing a total of 258 individual chocolates). These boxes were kept under continuous covert surveillance, with the time recorded when each chocolate was eaten. Median survival time of a chocolate. 191 out of 258 (74%) chocolates were observed being eaten. The mean total observation period was 254 minutes (95% confidence interval 179 to 329). The median survival time of a chocolate was 51 minutes (39 to 63). The model of chocolate consumption was non-linear, with an initial rapid rate of consumption that slowed with time. An exponential decay model best fitted these findings (model R(2)=0.844, P<0.001), with a survival half life (time taken for 50% of the chocolates to be eaten) of 99 minutes. The mean time taken to open a box of chocolates from first appearance on the ward was 12 minutes (95% confidence interval 0 to 24). Quality Street chocolates survived longer than Roses chocolates (hazard ratio for survival of Roses v Quality Street 0.70, 95% confidence interval 0.53 to 0.93, P=0.014). The highest percentages of chocolates were consumed by healthcare assistants (28%) and nurses (28%), followed by doctors (15%). From our observational study, chocolate survival in a hospital ward was relatively short, and was modelled well by an exponential decay model. Roses chocolates were preferentially consumed to Quality Street chocolates in a ward setting. Chocolates were consumed primarily by healthcare assistants and nurses, followed by doctors. Further practical studies are needed.

Hospitalization and survival in patients using epoprostenol for injection in the PROSPECT observational study.

Science.gov (United States)

Frantz, Robert P; Schilz, Robert J; Chakinala, Murali M; Badesch, David B; Frost, Adaani E; McLaughlin, Vallerie V; Barst, Robyn J; Rosenberg, Daniel M; Miller, Dave P; Hartline, Brian K; Benton, Wade W; Farber, Harrison W

2015-02-01

Few studies have prospectively reported outcomes in patients with pulmonary arterial hypertension (PAH) treated with epoprostenol in the modern-day era of oral therapy and combination treatments. The Registry to Prospectively Describe Use of Epoprostenol for Injection (Veletri, prolonged room temperature stable-epoprostenol [RTS-Epo]) in Patients with Pulmonary Arterial Hypertension (PROSPECT) was established to prospectively describe the course of PAH in patients prescribed RTS-Epo. PROSPECT is a multicenter, US-based drug registry of primarily group 1 patients with PAH treated with RTS-Epo who were parenteral-naive or parenteral-transitioned at enrollment. Patients were followed until discontinuation of RTS-Epo, withdrawal, loss to follow-up, death, or end of study (maximum 1 year). One-year freedom from hospitalization (FH) and survival estimates were summarized by prostacyclin history (parenteral-naive or parenteral-transitioned), sex, and chronic renal insufficiency (CRI). A total of 336 patients were included. The overall 1-year FH estimate was 51.0% ± 2.8% and was lower in parenteral-naive patients than parenteral-transitioned patients (42.8% ± 4.3% vs 57.1% ± 3.7%, respectively; P = .002). FH estimates were lower in male patients than female patients (38.3% ± 5.9% vs 54.6% ± 3.2%, respectively; P < .015) and in patients with CRI than patients without CRI (17.0% ± 8.4% vs 53.7% ± 2.9%, respectively; P < .001). The overall 1-year survival estimate was 84.0% ± 2.1%. Survival was poorer in parenteral-naive patients, male patients, and patients with CRI. Risk of hospitalization and mortality remain high in patients with PAH. In particular, patients who are parenteral-naive at initiation of RTS-Epo therapy, male patients, and patients with CRI require close monitoring and aggressive clinical management.

Electronic Banking in Nigeria: Concepts, Challenges and Prospects ...

African Journals Online (AJOL)

Electronic Banking in Nigeria: Concepts, Challenges and Prospects. ... examined its prospects for Nigerian banks and discussed associated risks. ... E banking, it also observed, holds enormous potentials for the banking industry in Nigeria.

Decannulation and Functional Outcome After Tracheostomy in Patients with Severe Stroke (DECAST): A Prospective Observational Study.

Science.gov (United States)

Schneider, Hauke; Hertel, Franziska; Kuhn, Matthias; Ragaller, Maximilian; Gottschlich, Birgit; Trabitzsch, Anne; Dengl, Markus; Neudert, Marcus; Reichmann, Heinz; Wöpking, Sigrid

2017-08-01

Tracheostomy is performed in ventilated stroke patients affected by persisting severe dysphagia, reduced level of consciousness, or prolonged mechanical ventilation. The study aim was to determine the frequency and predictors of successful decannulation and long-term functional outcome in tracheotomized stroke patients. A prospective single-center observational study recruited ventilated patients with ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage. Follow-up visits were performed at hospital discharge, 3, and 12 months. Competing risk analyses were performed to identify predictors of decannulation. We included 53 ventilated stroke patients who had tracheostomy. One year after tracheostomy, 19 patients were decannulated (median [IQR] time to decannulation 74 [58-117] days), 13 patients were permanently cannulated, and 21 patients died without prior removal of the cannula. Independent predictors for decannulation in our cohort were patient age (HR 0.95 [95% CI: 0.92-0.99] per one year increase, p = 0.003) and absence of sepsis (HR 4.44 [95% CI: 1.33-14.80], p = 0.008). Compared to surviving patients without cannula removal, decannulated patients had an improved functional outcome after one year (median modified Rankin Scale score 4 vs. 5 [p tracheostomy and was associated with better functional outcome compared to patients without decannulation. Further prospective studies with larger sample sizes are needed to confirm our results.

Strategies to diagnose ovarian cancer: new evidence from phase 3 of the multicentre international IOTA study.

Science.gov (United States)

Testa, A; Kaijser, J; Wynants, L; Fischerova, D; Van Holsbeke, C; Franchi, D; Savelli, L; Epstein, E; Czekierdowski, A; Guerriero, S; Fruscio, R; Leone, F P G; Vergote, I; Bourne, T; Valentin, L; Van Calster, B; Timmerman, D

2014-08-12

To compare different ultrasound-based international ovarian tumour analysis (IOTA) strategies and risk of malignancy index (RMI) for ovarian cancer diagnosis using a meta-analysis approach of centre-specific data from IOTA3. This prospective multicentre diagnostic accuracy study included 2403 patients with 1423 benign and 980 malignant adnexal masses from 2009 until 2012. All patients underwent standardised transvaginal ultrasonography. Test performance of RMI, subjective assessment (SA) of ultrasound findings, two IOTA risk models (LR1 and LR2), and strategies involving combinations of IOTA simple rules (SRs), simple descriptors (SDs) and LR2 with and without SA was estimated using a meta-analysis approach. Reference standard was histology after surgery. The areas under the receiver operator characteristic curves of LR1, LR2, SA and RMI were 0.930 (0.917-0.942), 0.918 (0.905-0.930), 0.914 (0.886-0.936) and 0.875 (0.853-0.894). Diagnostic one-step and two-step strategies using LR1, LR2, SR and SD achieved summary estimates for sensitivity 90-96%, specificity 74-79% and diagnostic odds ratio (DOR) 32.8-50.5. Adding SA when IOTA methods yielded equivocal results improved performance (DOR 57.6-75.7). Risk of Malignancy Index had sensitivity 67%, specificity 91% and DOR 17.5. This study shows all IOTA strategies had excellent diagnostic performance in comparison with RMI. The IOTA strategy chosen may be determined by clinical preference.

The effects of enactment and intention accessibility on prospective memory performance.

Science.gov (United States)

Schult, Janette C; Steffens, Melanie C

2017-05-01

The intention-superiority effect denotes faster response latencies to stimuli linked with a prospective memory task compared to stimuli linked with no prospective task or with a cancelled task. It is generally assumed that the increased accessibility of intention-related materials contributes to successful execution of prospective memory tasks at an appropriate opportunity. In two experiments we investigated the relationship between the intention-superiority effect and actual prospective memory performance under relatively realistic conditions. We also manipulated enactment versus observation encoding to further investigate the similarity in representations of enacted and to-be-enacted tasks. Additionally, Experiment 1 included a control condition to investigate the development of the intention-superiority effect over time. Participants were asked to perform prospective tasks at the end of the experiment to prepare the room for the next participant. They studied these preparatory tasks at the beginning of the experiment either by enacting them themselves or by observing the experimenter perform them. In Experiment 2, participants in a control condition did not intend to perform prospective tasks. We observed a smaller intention-superiority effect after enactment encoding than after observation encoding, but only if response latencies were assessed immediately before the prospective memory task. In addition, Experiment 2 suggested that the size of the intention-superiority effect is related to successful prospective memory performance, thus providing evidence for a functional relationship between accessibility and memory.

Prospective, Multi-Centre, Single-Arm Study of Mechanical Thrombectomy using Solitaire FR in Acute Ischemic Stroke-STAR

Science.gov (United States)

Pereira, Vitor M; Gralla, Jan; Davalos, Antoni; Bonafé, Alain; Castaño, Carlos; Chapot, Rene; Liebeskind, David S; Nogueira, Raul G; Arnold, Marcel; Sztajzel, Roman; Liebig, Thomas; Goyal, Mayank; Besselmann, Michael; Moreno, Alfredo; Schroth, Gerhard

2013-01-01

Background and Purpose Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire FR in patients with acute ischemic stroke. Methods STAR was an international, multicenter, prospective, single-arm study of Solitaire FR thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary endpoint was the revascularization rate (3TICI 2b) of the occluded vessel as determined by an independent core lab. The secondary endpoint was the rate of good functional outcome (defined as 90-day modified Rankin scale (mRS) 0–2). Results A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale (NIHSS) was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and/or procedure related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic. Conclusions In this single arm study, treatment with the Solitaire™ FR device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days. Clinical Trial Registration This study is registered with ClinicalTrials.gov, number NCT01327989. PMID:23908066

Development and validation of multivariable models to predict mortality and hospitalization in patients with heart failure

NARCIS (Netherlands)

Voors, Adriaan A.; Ouwerkerk, Wouter; Zannad, Faiez; van Veldhuisen, Dirk J.; Samani, Nilesh J.; Ponikowski, Piotr; Ng, Leong L.; Metra, Marco; ter Maaten, Jozine M.; Lang, Chim C.; Hillege, Hans L.; van der Harst, Pim; Filippatos, Gerasimos; Dickstein, Kenneth; Cleland, John G.; Anker, Stefan D.; Zwinderman, Aeilko H.

Introduction From a prospective multicentre multicountry clinical trial, we developed and validated risk models to predict prospective all-cause mortality and hospitalizations because of heart failure (HF) in patients with HF. Methods and results BIOSTAT-CHF is a research programme designed to

Development and validation of multivariable models to predict mortality and hospitalization in patients with heart failure

NARCIS (Netherlands)

Voors, Adriaan A.; Ouwerkerk, Wouter; Zannad, Faiez; van Veldhuisen, Dirk J.; Samani, Nilesh J.; Ponikowski, Piotr; Ng, Leong L.; Metra, Marco; ter Maaten, Jozine M.; Lang, Chim C.; Hillege, Hans L.; van der Harst, Pim; Filippatos, Gerasimos; Dickstein, Kenneth; Cleland, John G.; Anker, Stefan D.; Zwinderman, Aeilko H.

2017-01-01

Introduction From a prospective multicentre multicountry clinical trial, we developed and validated risk models to predict prospective all-cause mortality and hospitalizations because of heart failure (HF) in patients with HF. Methods and results BIOSTAT-CHF is a research programme designed to

The BraveNet prospective observational study on integrative medicine treatment approaches for pain.

Science.gov (United States)

Abrams, Donald I; Dolor, Rowena; Roberts, Rhonda; Pechura, Constance; Dusek, Jeffery; Amoils, Sandi; Amoils, Steven; Barrows, Kevin; Edman, Joel S; Frye, Joyce; Guarneri, Erminia; Kligler, Ben; Monti, Daniel; Spar, Myles; Wolever, Ruth Q

2013-06-24

Chronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures. Our prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks. Of 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (-23%) and interference (-28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12. Among participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures. ClinicalTrials.gov, NCT01186341.

Variability of linezolid concentrations after standard dosing in critically ill patients: a prospective observational study

Science.gov (United States)

2014-01-01

Introduction Severe infections in intensive care patients show high morbidity and mortality rates. Linezolid is an antimicrobial drug frequently used in critically ill patients. Recent data indicates that there might be high variability of linezolid serum concentrations in intensive care patients receiving standard doses. This study was aimed to evaluate whether standard dosing of linezolid leads to therapeutic serum concentrations in critically ill patients. Methods In this prospective observational study, 30 critically ill adult patients with suspected infections received standard dosing of 600 mg linezolid intravenously twice a day. Over 4 days, multiple serum samples were obtained from each patient, in order to determine the linezolid concentrations by liquid chromatography tandem mass spectrometry. Results A high variability of serum linezolid concentrations was observed (range of area under the linezolid concentration time curve over 24 hours (AUC24) 50.1 to 453.9 mg/L, median 143.3 mg*h/L; range of trough concentrations (Cmin) linezolid concentrations over 24 hours and at single time points (defined according to the literature as AUC24  400 mg*h/L and Cmin > 10 mg/L) were observed for 7 of the patients. Conclusions A high variability of linezolid serum concentrations with a substantial percentage of potentially subtherapeutic levels was observed in intensive care patients. The findings suggest that therapeutic drug monitoring of linezolid might be helpful for adequate dosing of linezolid in critically ill patients. Trial registration Clinicaltrials.gov NCT01793012. Registered 24 January 2013. PMID:25011656

A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

DEFF Research Database (Denmark)

Kasch, Helge; Kongsted, Alice; Qerama, Erisela

2013-01-01

OBJECTIVES: An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. DESIGN: The design was an observational prospective study of risk factors embedded in a randomised controlled study. SETTING: Acute whiplash...... patients from units, general practitioners in four Danish counties were referred to two research centres. PARTICIPANTS: During a 2-year inclusion period, acute consecutive whiplash-injured (age 18-70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I-III, symptoms...... and examined by a study nurse after 5 days; 605 were completed after 1 year. A risk score which included items of initial neck pain/headache intensity, a number of non-painful complaints and active neck mobility was applied. The primary outcome parameter was 1-year work disability. RESULTS: The risk score...

Incidence of cervical cancer after several negative smear results by age 50: prospective observational study

DEFF Research Database (Denmark)

Rebolj, Matejka; van Ballegooijen, Marjolein; Lynge, Elsebeth

2009-01-01

/100,000 (95% confidence interval 33 to 51) in the younger group and 36/100,000 (24 to 52) in the older group (P=0.48). The cumulative incidence rate of cervical intraepithelial neoplasia grade I+ was twice as high in the younger than in the older group (Pcervical cancer......OBJECTIVE: To determine the incidence of cervical cancer after several negative cervical smear tests at different ages. DESIGN: Prospective observational study of incidence of cervical cancer after the third consecutive negative result based on individual level data in a national registry...... of histopathology and cytopathology (PALGA). SETTING: Netherlands, national data. Population 218,847 women aged 45-54 and 445,382 aged 30-44 at the time of the third negative smear test. MAIN OUTCOME MEASURES: 10 year cumulative incidence of interval cervical cancer. RESULTS: 105 women developed cervical cancer...

Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study

OpenAIRE

García-Gutierrez, Susana; Orive, Miren; Sarasqueta, Cristina; Legarreta, Maria Jose; Gonzalez, Nerea; Redondo, Maximino; Rivero, Amado; Serrano-Aguilar, Pedro; Castells, Xavier; Quintana, Jose Maria; Sala, Maria

2018-01-01

Background Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Methods Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to...

Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective

Directory of Open Access Journals (Sweden)

von Dadelszen Peter

2010-07-01

Full Text Available Abstract Background For ethical approval of a multicentre study in Canada, investigators must apply separately to individual Research Ethics Boards (REBs. In principle, the protection of human research subjects is of utmost importance. However, in practice, the process of multicentre ethics review can be time consuming and costly, requiring duplication of effort for researchers and REBs. We used our experience with ethical review of The Canadian Perinatal Network (CPN, to gain insight into the Canadian system. Methods The applications forms of 16 different REBs were abstracted for a list of standardized items. The application process across sites was compared. Correspondence between the REB and the investigators was documented in order to construct a timeline to approval, identify the specific issues raised by each board, and describe how they were resolved. Results Each REB had a different application form. Most (n = 9 had a two or three step application process. Overall, it took a median of 31 days (range 2-174 days to receive an initial response from the REB. Approval took a median of 42 days (range 4-443 days. Privacy and consent were the two major issues raised. Several additional minor or administrative issues were raised which delayed approval. Conclusions For CPN, the Canadian REB process of ethical review proved challenging. REBs acted independently and without unified application forms or submission procedures. We call for a critical examination of the ethical, privacy and institutional review processes in Canada, to determine the best way to undertake multicentre review.

Evans syndrome in children. Long-term outcome in a prospective French national observational cohort.

Directory of Open Access Journals (Sweden)

Nathalie eAladjidi

2015-09-01

Full Text Available Evans syndrome (ES is a rare autoimmune disorder whose long-term follow-up characteristics are unknown. Patients under 18 at the time of diagnosis of a first autoimmune cytopenia have been included since 2004 in a national prospective observational cohort. In 2014, 156 children diagnosed between 1981 and 2014 with ES, were analyzed. The median age at initial cytopenia was 5.4 (0.2-17.2 years old. For 85 sequential cases, the median delay between the episodes of AIHA and ITP was 2.4 years (0.1–16.3. The median follow-up since ES diagnosis was 6.5 years (0.1-28.8. ES revealed underlying diseases in 10% of children; in 60% of patients, various associated immune manifestations were observed, and ES remained primary in 30%. Five-year ITP and AIHA relapse-free survival were respectively 25% and 61%. In all, 69% of children required one or more than one second-line immune treatment and 15 patients (10% died at a median age of 14.3 years (1.7-28.1.This national work provides the first consistent clinical description for ES and underscores the high percentage of associated immune manifestations, the long-term complications, and treatment toxicities. Current challenges include the identification of underlying genetic immune dysregulations and better characterization of subgroups of patients and of second-line therapy strategies.

Doxycycline in the treatment of respiratory tract infections. Results of a pan-European multi-centre trial.

Science.gov (United States)

Pestel, M

1975-01-01

In the winter of 1973-4, general practitioners from seven European countries took part in a multi-centre trial of doxycycline in the treatment of infections of the respiratory tract. The carefully designed protocol was observed by all participants. A total of 1,747 patients were admitted to the trial; their ages ranged from 6 years to over 80. The commonest diagnoses (50%) were acute bronchitis and acute exacerbations of chronic bronchitis. On the recommended dosage of 200 mg doxycycline on the first day, followed by 100 mg daily thereafter (though 200 mg could be continued daily in severe cases), 87% of patients achieved good or very good results. Both subjective (pain) and objective (sputum volume and viscosity, temperature, cough) measures showed rapid improvement, usually by the third to fifth days. Side-effects were minimal and mainly gastrointestinal and caused only 4 patients to discontinue treatment. Overall, doxycycline proved its effectiveness and rapidity of action.

A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial

NARCIS (Netherlands)

Leontjevas, R.; Gerritsen, D.L.; Smalbrugge, M.; Teerenstra, S.; Vernooij-Dassen, M.J.F.J.; Koopmans, R.T.C.M.

2013-01-01

BACKGROUND: Depression in nursing-home residents is often under-recognised. We aimed to establish the effectiveness of a structural approach to its management. METHODS: Between May 15, 2009, and April 30, 2011, we undertook a multicentre, stepped-wedge cluster-randomised trial in four provinces of

A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly

DEFF Research Database (Denmark)

Prescott, Eva; Meindersma, Esther P; van der Velde, Astrid E

2016-01-01

of EU-CaRE is to map the efficiency of current CR of the elderly in Europe, and to investigate whether mCR is an effective alternative in terms of efficacy, adherence and sustainability. METHODS AND RESULTS: The EU-CaRE study includes patients aged 65 years or older with ischaemic heart disease or who...... on effectiveness and sustainability of current cardiac rehabilitation programmes in the elderly (EU-CaRE) project consists of an observational study and an open prospective, investigator-initiated multicentre randomised controlled trial (RCT) involving mobile telemonitoring guided CR (mCR). OBJECTIVE: The aim...... and sustainability. CONCLUSION: The study will provide important information to improve CR in the elderly. The EU-CaRE RCT is the first European multicentre study of mCR as an alternative for elderly patients not attending usual CR....

Misoprostol for cervical priming prior to hysteroscopy in postmenopausal and premenopausal nulliparous women; a multicentre randomised placebo controlled trial

NARCIS (Netherlands)

Tasma, M L; Louwerse, M D; Hehenkamp, W J; Geomini, P M; Bongers, M Y; Veersema, S; van Kesteren, P J; Tromp, E; Huirne, J A; Graziosi, G C

OBJECTIVE: To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women. DESIGN: Randomised multicentre double-blind placebo controlled trial. SETTING: Two Dutch teaching hospitals and one Dutch university medical

Factors associated with survival of epiploic foramen entrapment colic: a multicentre, international study.

Science.gov (United States)

Archer, D C; Pinchbeck, G L; Proudman, C J

2011-08-01

Epiploic foramen entrapment (EFE) has been associated with reduced post operative survival compared to other types of colic but specific factors associated with reduced long-term survival of these cases have not been evaluated in a large number of horses using survival analysis. To describe post operative survival of EFE cases and to identify factors associated with long-term survival. A prospective, multicentre, international study was conducted using clinical data and long-term follow-up information for 126 horses diagnosed with EFE during exploratory laparotomy at 15 clinics in the UK, Ireland and USA. Descriptive data were generated and survival analysis performed to identify factors associated with reduced post operative survival. For the EFE cohort that recovered following anaesthesia, survival to hospital discharge was 78.5%. Survival to 1 and 2 years post operatively was 50.6 and 34.3%, respectively. The median survival time of EFE cases undergoing surgery was 397 days. Increased packed cell volume (PCV) and increased length of small intestine (SI) resected were significantly associated with increased likelihood of mortality when multivariable analysis of pre- and intraoperative variables were analysed. When all pre-, intra- and post operative variables were analysed separately, only horses that developed post operative ileus (POI) were shown to be at increased likelihood of mortality. Increased PCV, increased length of SI resected and POI are all associated with increased likelihood of mortality of EFE cases. This emphasises the importance of early diagnosis and treatment and the need for improved strategies in the management of POI in order to reduce post operative mortality in these cases. The present study provides evidence-based information to clinicians and owners of horses undergoing surgery for EFE about long-term survival. These results are applicable to university and large private clinics over a wide geographical area. © 2011 EVJ Ltd.

ZOOM or Non-ZOOM? Assessing Spinal Cord Diffusion Tensor Imaging Protocols for Multi-Centre Studies.

Directory of Open Access Journals (Sweden)

Rebecca S Samson

Full Text Available The purpose of this study was to develop and evaluate two spinal cord (SC diffusion tensor imaging (DTI protocols, implemented at multiple sites (using scanners from two different manufacturers, one available on any clinical scanner, and one using more advanced options currently available in the research setting, and to use an automated processing method for unbiased quantification. DTI parameters are sensitive to changes in the diseased SC. However, imaging the cord can be technically challenging due to various factors including its small size, patient-related and physiological motion, and field inhomogeneities. Rapid acquisition sequences such as Echo Planar Imaging (EPI are desirable but may suffer from image distortions. We present a multi-centre comparison of two acquisition protocols implemented on scanners from two different vendors (Siemens and Philips, one using a reduced field-of-view (rFOV EPI sequence, and one only using options available on standard clinical scanners such as outer volume suppression (OVS. Automatic analysis was performed with the Spinal Cord Toolbox for unbiased and reproducible quantification of DTI metrics in the white matter. Images acquired using the rFOV sequence appear less distorted than those acquired using OVS alone. SC DTI parameter values obtained using both sequences at all sites were consistent with previous measurements made at 3T. For the same scanner manufacturer, DTI parameter inter-site SDs were smaller for the rFOV sequence compared to the OVS sequence. The higher inter-site reproducibility (for the same manufacturer and acquisition details, i.e. ZOOM data acquired at the two Philips sites of rFOV compared to the OVS sequence supports the idea that making research options such as rFOV more widely available would improve accuracy of measurements obtained in multi-centre clinical trials. Future multi-centre studies should also aim to match the rFOV technique and signal-to-noise ratios in all

Endothelial Nitric Oxide Pathways in the Pathophysiology of Dengue: A Prospective Observational Study.

Science.gov (United States)

Yacoub, Sophie; Lam, Phung Khanh; Huynh, Trieu Trung; Nguyen Ho, Hong Hanh; Dong Thi, Hoai Tam; Van, Nguyen Thu; Lien, Le Thi; Ha, Quyen Nguyen Than; Le, Duyen Huynh Thi; Mongkolspaya, Juthathip; Culshaw, Abigail; Yeo, Tsin Wen; Wertheim, Heiman; Simmons, Cameron; Screaton, Gavin; Wills, Bridget

2017-10-16

Dengue can cause increased vascular permeability that may lead to hypovolemic shock. Endothelial dysfunction may underlie this; however, the association of endothelial nitric oxide (NO) pathways with disease severity is unknown. We performed a prospective observational study in 2 Vietnamese hospitals, assessing patients presenting early (dengue. The reactive hyperemic index (RHI), which measures endothelium-dependent vasodilation and is a surrogate marker of endothelial function and NO bioavailability, was evaluated using peripheral artery tonometry (EndoPAT), and plasma levels of l-arginine, arginase-1, and asymmetric dimethylarginine were measured at serial time-points. The main outcome of interest was plasma leakage severity. Three hundred fourteen patients were enrolled; median age of the participants was 21(interquartile range, 13-30) years. No difference was found in the endothelial parameters between dengue and other febrile illness. Considering dengue patients, the RHI was significantly lower for patients with severe plasma leakage compared to those with no leakage (1.46 vs 2.00; P dengue illness and correlates with hypoargininemia and high arginase-1 levels. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

Polyp prevalence at colonoscopy among Nigerians: A prospective ...

African Journals Online (AJOL)

Polyp prevalence at colonoscopy among Nigerians: A prospective observational study. ... Materials and Methods: This is a prospective study of all colonoscopy examinations performed at the endoscopy unit of our hospital from January, 2007 to December 2013. The patient demographics, indications for colonoscopy, ...

NILVAD protocol: a European multicentre double-blind placebo-controlled trial of nilvadipine in mild-to-moderate Alzheimer's disease

NARCIS (Netherlands)

Lawlor, B.; Kennelly, S.; O'Dwyer, S.; Cregg, F.; Walsh, C.; Coen, R.; Kenny, R.A.; Howard, R.; Murphy, C.; Adams, J.; Daly, L.; Segurado, R.; Gaynor, S.; Crawford, F.; Mullan, M.; Lucca, U.; Banzi, R.; Pasquier, F.; Breuilh, L.; Riepe, M.; Kalman, J.; Wallin, A.; Borjesson, A.; Molloy, W.; Tsolaki, M.; Olde Rikkert, M.G.M.

2014-01-01

INTRODUCTION: This study is a European multicentre, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of nilvadipine as a disease course modifying treatment for mild-to-moderate Alzheimer's disease (AD) in a phase III study that will run for a period of 82

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

Directory of Open Access Journals (Sweden)

Freitag Christine M

2013-01-01

Full Text Available Abstract Background Group-based social skills training (SST has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD. To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS compared to treatment as usual (TAU. It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

Directory of Open Access Journals (Sweden)

Pascal H Colson

Full Text Available To estimate the incidence of active bleeding after cardiac surgery (AB based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications.AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications.Among 4,904 patients, 129 experienced AB (2.6%, among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16% but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication.A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

Active Bleeding after Cardiac Surgery: A Prospective Observational Multicenter Study.

Science.gov (United States)

Colson, Pascal H; Gaudard, Philippe; Fellahi, Jean-Luc; Bertet, Héléna; Faucanie, Marie; Amour, Julien; Blanloeil, Yvonnick; Lanquetot, Hervé; Ouattara, Alexandre; Picot, Marie Christine

2016-01-01

To estimate the incidence of active bleeding after cardiac surgery (AB) based on a definition directly related on blood flow from chest drainage; to describe the AB characteristics and its management; to identify factors of postoperative complications. AB was defined as a blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or in case of reoperation for hemostasis during the first 12 postoperative hours. The definition was applied in a prospective longitudinal observational study involving 29 French centers; all adult patients undergoing cardiac surgery with cardiopulmonary bypass were included over a 3-month period. Perioperative data (including blood product administration) were collected. To study possible variation in clinical practice among centers, patients were classified into two groups according to the AB incidence of the center compared to the overall incidence: "Low incidence" if incidence is lower and "High incidence" if incidence is equal or greater than overall incidence. Logistic regression analysis was used to identify risk factors of postoperative complications. Among 4,904 patients, 129 experienced AB (2.6%), among them 52 reoperation. Postoperative bleeding loss was 1,000 [820;1,375] ml and 1,680 [1,280;2,300] ml at 6 and 24 hours respectively. Incidence of AB varied between centers (0 to 16%) but was independent of in-centre cardiac surgical experience. Comparisons between groups according to AB incidence showed differences in postoperative management. Body surface area, preoperative creatinine, emergency surgery, postoperative acidosis and red blood cell transfusion were risk factors of postoperative complication. A blood loss > 1.5 ml/kg/h for 6 consecutive hours within the first 24 hours or early reoperation for hemostasis seems a relevant definition of AB. This definition, independent of transfusion, adjusted to body weight, may assess real time bleeding occurring early after surgery.

Early invasive versus non-invasive treatment in patients with non-ST-elevation acute coronary syndrome (FRISC-II): 15 year follow-up of a prospective, randomised, multicentre study.

Science.gov (United States)

Wallentin, Lars; Lindhagen, Lars; Ärnström, Elisabet; Husted, Steen; Janzon, Magnus; Johnsen, Søren Paaske; Kontny, Frederic; Kempf, Tibor; Levin, Lars-Åke; Lindahl, Bertil; Stridsberg, Mats; Ståhle, Elisabeth; Venge, Per; Wollert, Kai C; Swahn, Eva; Lagerqvist, Bo

2016-10-15

The FRISC-II trial was the first randomised trial to show a reduction in death or myocardial infarction with an early invasive versus a non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome. Here we provide a remaining lifetime perspective on the effects on all cardiovascular events during 15 years' follow-up. The FRISC-II prospective, randomised, multicentre trial was done at 58 Scandinavian centres in Sweden, Denmark, and Norway. Between June 17, 1996, and Aug 28, 1998, we randomly assigned (1:1) 2457 patients with non-ST-elevation acute coronary syndrome to an early invasive treatment strategy, aiming for revascularisation within 7 days, or a non-invasive strategy, with invasive procedures at recurrent symptoms or severe exercise-induced ischaemia. Plasma for biomarker analyses was obtained at randomisation. For long-term outcomes, we linked data with national health-care registers. The primary endpoint was a composite of death or myocardial infarction. Outcomes were compared as the average postponement of the next event, including recurrent events, calculated as the area between mean cumulative count-of-events curves. Analyses were done by intention to treat. At a minimum of 15 years' follow-up on Dec 31, 2014, data for survival status and death were available for 2421 (99%) of the initially recruited 2457 patients, and for other events after 2 years for 2182 (89%) patients. During follow-up, the invasive strategy postponed death or next myocardial infarction by a mean of 549 days (95% CI 204-888; p=0·0020) compared with the non-invasive strategy. This effect was larger in non-smokers (mean gain 809 days, 95% CI 402-1175; p interaction =0·0182), patients with elevated troponin T (778 days, 357-1165; p interaction =0·0241), and patients with high concentrations of growth differentiation factor-15 (1356 days, 507-1650; p interaction =0·0210). The difference was mainly driven by postponement of new myocardial infarction

The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial

DEFF Research Database (Denmark)

Lindholt, J S; Gottschalksen, B; Johannesen, N

2011-01-01

To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study.......To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study....

Prospective study of catheter-related central vein thrombosis in home parenteral nutrition patients with benign disease using serial venous Doppler ultrasound.

Science.gov (United States)

Cuerda, Cristina; Joly, Francisca; Corcos, Olivier; Concejo, Javier; Puiggrós, Carolina; Gil, Carmen; Pironi, Loris

2016-02-01

Catheter-related central vein thrombosis (CRVT) is a severe complication of home parenteral nutrition (HPN) that may be clinically manifest or subclinical. The aims of the study were to prospectively investigate the incidence of CRVT in patients on HPN with benign disease and determine the influence of different variables on this complication. A prospective, multicentre, observational study in the Home Artificial Nutrition-Chronic Intestinal Failure ESPEN group was performed. Patients with benign disease starting HPN or already on HPN after the insertion of a new catheter, were recruited and followed up with Color Doppler Duplex Sonography (CDDS) evaluations at baseline, 1 week, 3, 6 and 12 months after catheter insertion. Fisher's exact test was used to calculate the association of different variables (related to the patient, type of catheter, vascular access, insertion method, catheter care and anticoagulant treatment) with CRVT events. Sixty-two patients (31 males, 31 females) aged 50 ± 19 (19-83) years were included and followed for a median 363 days, with an Inter Quartile Range of 180-365 days, and a total of 16,186 catheter-days. Six patients had previous CRVT and 16 had history of thromboembolic disease (pulmonary and mesenteric). Forty one patients were receiving anticoagulant treatment. Fifty two patients had tunneled catheters and 10 implanted ports. Two patients had symptomatic thrombosis at 3 and 12 months of follow-up (2 and 3 weeks after normal routine CDDS evaluation). The incidence of CRVT was 0.045/catheter/year. CRVT was not significantly associated with any of the variables analyzed. The incidence of CRVT in patients on HPN for benign disease followed by CDDS is low in the first year of catheterization. We did not observe any case of asymptomatic CRVT. Based on our data, CDDS seems to have low effectiveness as a screening tool for CRVT in asymptomatic patients on HPN with benign disease. Copyright © 2015 Elsevier Ltd and European Society for

The predictive value of treatment response using FDG PET performed on day 21 of chemoradiotherapy in patients with oesophageal squamous cell carcinoma. A prospective, multicentre study (RTEP3)

International Nuclear Information System (INIS)

Palie, Odre; Vera, Pierre; Michel, Pierre; Di Fiore, Frederic; Menard, Jean-Francois; Rousseau, Caroline; Bridji, Boumediene; Rio, Emmanuel; Benyoucef, Ahmed; Meyer, Marc-Etienne; Jalali, Khadija; Bardet, Stephane; M'Vondo, Che Mabubu; Olivier, Pierre; Faure, Guillaume; Itti, Emmanuel; Diana, Christian; Houzard, Claire; Mornex, Francoise

2013-01-01

therefore TLG 40 1 and TLG p 1 , but not the SUV values, were significantly lower in patients with CR at 3 months. SUVmax 1 , TV p 1 and TLG p 1 were significantly lower in patients with CR at 1 year. With respect to the predictive value of PET 2 , only TV 40 2 and TV p 2 values, and therefore TLG 40 2 and TLG p 2 , but not the SUV values, were significantly lower in patients with CR at 3 months. None of the PET 2 parameters had significant value in predicting patient outcome at 1 year. The changes in SUVmax, TV 40 , TV p , TLG 40 and TLG p between PET 1 and PET 2 had no relationship to patient outcome at 3 months or 1 year. This prospective, multicentre study performed in a selected population of patients with oesophageal squamous cell cancer demonstrates that the parameters derived from baseline PET 1 are good predictors of response to CRT. Specifically, a high TV and TLG are associated with a poor response to CRT at 3 months and 1 year, and a high SUVmax is associated with a poor response to CRT at 1 year. FDG PET performed during CRT on day 21 appears to have less clinical relevance. However, patients with a large functional TV on day 21 of CRT have a poor clinical outcome (ClinicalTrials.gov NCT 00934505). (orig.)

A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated with ADHD in Central and Eastern Europe and Eastern Asia

Science.gov (United States)

Goetz, Michal; Yeh, Chin-Bin; Ondrejka, Igor; Akay, Aynur; Herczeg, Ilona; Dobrescu, Iuliana; Kim, Boong Nyun; Jin, Xingming; Riley, Anne W.; Martenyi, Ferenc; Harrison, Gavan; Treuer, Tamas

2012-01-01

Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for…

International prospective observational study of upper gastrointestinal haemorrhage: Does weekend admission affect outcome?

DEFF Research Database (Denmark)

Murray, Iain A.; Dalton, Harry R.; Stanley, Adrian J.

2017-01-01

Introduction Out of hours admissions have higher mortality for many conditions but upper gastrointestinal haemorrhage studies have produced variable outcomes. Methods Prospective study of 12 months consecutive admissions of upper gastrointestinal haemorrhage from four international high volume...

Heterogeneous FDG-guided dose-escalation for locally advanced NSCLC (the NARLAL2 trial): Design and early dosimetric results of a randomized, multi-centre phase-III study

DEFF Research Database (Denmark)

Møller, Ditte Sloth; Nielsen, Tine Bjørn; Brink, Carsten

2017-01-01

Background and purpose: Local recurrence is frequent in locally advanced NSCLC and is primarily located in FDG-avid parts of tumour and lymph nodes. Aiming at improving local control without increasing toxicity, we designed a multi-centre phase-III trial delivering inhomogeneous dose-escalation d......Background and purpose: Local recurrence is frequent in locally advanced NSCLC and is primarily located in FDG-avid parts of tumour and lymph nodes. Aiming at improving local control without increasing toxicity, we designed a multi-centre phase-III trial delivering inhomogeneous dose...

Prediction of immediate postoperative pain using the analgesia/nociception index: a prospective observational study.

Science.gov (United States)

Boselli, E; Bouvet, L; Bégou, G; Dabouz, R; Davidson, J; Deloste, J-Y; Rahali, N; Zadam, A; Allaouchiche, B

2014-04-01

The analgesia/nociception index (ANI) is derived from heart rate variability, ranging from 0 (maximal nociception) to 100 (maximal analgesia), to reflect the analgesia/nociception balance during general anaesthesia. This should be correlated with immediate postoperative pain in the post-anaesthesia care unit (PACU). The aim of this study was to evaluate the performance of ANI measured at arousal from general anaesthesia to predict immediate postoperative pain on arrival in PACU. Two hundred patients undergoing ear, nose, and throat or lower limb orthopaedic surgery with general anaesthesia using an inhalational agent and remifentanil were included in this prospective observational study. The ANI was measured immediately before tracheal extubation and pain intensity was assessed within 10 min of arrival in PACU using a 0-10 numerical rating scale (NRS). The relationship between ANI and NRS was assessed using linear regression. A receiver-operating characteristic (ROC) curve was used to evaluate the performance of ANI to predict NRS>3. A negative linear relationship was observed between ANI immediately before extubation and NRS on arrival in PACU. Using a threshold of 3 were both 86% with 92% negative predictive value, corresponding to an area under the ROC curve of 0.89. The measurement of ANI immediately before extubation after inhalation-remifentanil anaesthesia was significantly associated with pain intensity on arrival in PACU. The performance of ANI for the prediction of immediate postoperative pain is good and may assist physicians in optimizing acute pain management. ClinicalTrials.gov NCT01796249.

The relationship between serum ammonia level and neurologic complications in patients with acute glufosinate ammonium poisoning: A prospective observational study.

Science.gov (United States)

Cha, Y S; Kim, H; Lee, Y; Choi, E H; Kim, H I; Kim, O H; Cha, K-C; Lee, K H; Hwang, S O

2018-06-01

Glufosinate ammonium poisoning can cause neurological complications even after a symptom-free period. We prospectively investigated the predictors of neurologic complications in acute glufosinate ammonium poisoning and the change of serum ammonia level as a predictor of patient's presence and recovery of neurologic complication. This prospective observational study collected data from consecutive patients diagnosed with acute glufosinate ammonium poisoning between September 2014 and June 2016. Serum ammonia was serially measured. The patients were divided into two groups: the neurologic complication group and the nonneurologic complication group. We also defined 25 other insecticide- or herbicide-poisoned patients as controls. The neurologic complication group included 18 patients (72.0%). The latency period for neurologic complications was within 48-h postingestion. The peak ammonia level was statistically higher in the neurologic complication group than in the control group ( p glufosinate ammonium poisoning, serial serum ammonia level measurements are needed and a serum peak ammonia level greater than 90 μg/dL is a predictor of neurologic complications. Also, it is important to treat the hyperammonemia in acute glufosinate ammonium poisoning.

Circulating tumour cells and pathological complete response: independent prognostic factors in inflammatory breast cancer in a pooled analysis of two multicentre phase II trials (BEVERLY-1 and -2) of neoadjuvant chemotherapy combined with bevacizumab.

Science.gov (United States)

Pierga, J-Y; Bidard, F-C; Autret, A; Petit, T; Andre, F; Dalenc, F; Levy, C; Ferrero, J-M; Romieu, G; Bonneterre, J; Lerebours, F; Bachelot, T; Kerbrat, P; Campone, M; Eymard, J-C; Mouret-Reynier, M-A; Gligorov, J; Hardy-Bessard, A-C; Lortholary, A; Soulie, P; Boher, J-M; Proudhon, C; Charafe-Jaufret, E; Lemonnier, J; Bertucci, F; Viens, P

2017-01-01

We present a pooled analysis of predictive and prognostic values of circulating tumour cells (CTC) and circulating endothelial cells (CEC) in two prospective trials of patients with inflammatory breast cancer (IBC) treated with neoadjuvant chemotherapy combined with neoadjuvant and adjuvant bevacizumab. Nonmetastatic T4d patients were enrolled in two phase II multicentre trials, evaluating bevacizumab in combination with sequential neoadjuvant chemotherapy of four cycles of FEC followed by four cycles of docetaxel in HER2-negative tumour (BEVERLY-1) or docetaxel and trastuzumab in HER2-positive tumour (BEVERLY-2). CTC and CEC were detected in 7.5 and 4 ml of blood, respectively, with the CellSearch System. From October 2008 to September 2010, 152 patients were included and 137 were evaluable for CTC and CEC. At baseline, 55 patients had detectable CTC (39%). After four cycles of chemotherapy, a dramatic drop in CTC to a rate of 9% was observed (P < 0.01). Pathological complete response (pCR) rate was 40%. No correlation was found between CTC or CEC levels and pCR rate. Median follow-up was 43 months. CTC detection (≥1 CTC/7.5 ml) at baseline was associated with shorter 3-year disease-free survival (39% versus 70% for patients without CTC, P < 0.01, HR 2.80) and shorter 3-year overall survival (OS) (P < 0.01). In multivariate analysis, independent prognostic parameters for shorter survival were absence of hormonal receptors, no pCR and CTC detection at baseline. CEC level at baseline or variations during treatment had no prognostic value. In this pooled analysis of two prospective trials in nonmetastatic IBC, detection rate of CTC was 39% with a strong and independent prognostic value for survival. Combination of pCR after neoadjuvant treatment with no CTC detection at baseline isolated a subgroup of IBC with excellent OS (94% 3-year OS), suggesting that CTC count could be part of IBC stratification in prospective trials. © The Author 2016

Simulation-based team training for multi-professional obstetric care teams to improve patient outcome : a multicentre, cluster randomised controlled trial

NARCIS (Netherlands)

Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

OBJECTIVE: To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. DESIGN: Multicentre, open, cluster randomised controlled trial. SETTING: Obstetric units in the Netherlands. POPULATION: Women with a singleton pregnancy beyond 24 weeks of

Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

DEFF Research Database (Denmark)

Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian

2006-01-01

Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University...

Interim PET Response-adapted Strategy in Untreated Advanced Stage Hodgkin Lymphoma: Results of GOELAMS LH 2007 Phase 2 Multicentric Trial.

Science.gov (United States)

Carras, Sylvain; Dubois, Benjamin; Senecal, Delphine; Jais, Jean-Philippe; Peoc'h, Michel; Quittet, Philippe; Foussard, Charles; Bouabdallah, Krimo; Gastinne, Thomas; Jourdan, Eric; Sanhes, Laurence; Ertault, Marjan; Lamy, Thierry; Molina, Lysiane

2018-03-01

Patients with advanced stage Hodgkin lymphoma still present unsatisfactory outcomes. The Groupe d'étude des Leucémies Aigues et des Maladies du Sang (GOELAMS) group conducted a prospective multicentric trial (NCT00920153) for advanced stage Hodgkin lymphoma to evaluate a positron emission tomography (PET)-adapted strategy. Patients received an intensive regimen (VABEM [vindesine, doxorubicin, carmustine, etoposide, and methylprednisolone]) in front-line and interim 18F FDG-PET evaluation after 2 courses (PET-2). Patients with negative PET-2 findings received 1 additional course. Patients with positive PET-2 findings underwent early salvage therapy followed by high-dose therapy/autologous stem cell transplantation. Fifty-one patients were included. The final complete remission rate was 88%. With a median follow up of 5.3 years, 5-year event-free survival and overall survival rates were 75.3% and 85.3%, respectively, for the whole cohort. Patients who were PET-2-negative had 5-year event-free survival and overall survival rates of, respectively, 77.8% and 88.2% versus 85.1% and 91.7% for patients who were PET-2-positive. A PET-guided strategy with early salvage therapy and high-dose therapy/autologous stem cell transplantation for patients with interim PET-2-positive findings is safe and feasible and provide similar outcome as patients with a negative PET-2. Copyright © 2018 Elsevier Inc. All rights reserved.

Relative associations between depression and anxiety on adverse cardiovascular events: does a history of coronary artery disease matter? A prospective observational study

OpenAIRE

Pelletier, Roxanne; Bacon, Simon L; Arsenault, Andr?; Dupuis, Jocelyn; Laurin, Catherine; Blais, Lucie; Lavoie, Kim L

2015-01-01

Objectives To assess whether depression and anxiety increase the risk of mortality and major adverse cardiovascular events (MACE), among patients with and without coronary artery disease (CAD). Design and setting, and patients DECADE (Depression Effects on Coronary Artery Disease Events) is a prospective observational study of 2390 patients referred at the Montreal Heart Institute. Patients were followed for 8.8?years, between 1998 and 2009. Depression and anxiety were assessed using a psychi...

Neoadjuvant conformal chemoradiation with induction chemotherapy for rectal adenocarcinoma. A prospective observational study.

Science.gov (United States)

Fekete, Zsolt; Muntean, Alina-Simona; Hica, Ştefan; Rancea, Alin; Resiga, Liliana; Csutak, Csaba; Todor, Nicolae; Nagy, Viorica Magdalena

2014-06-01

The purpose of this prospective observational study was to evaluate the rate and the prognostic factors for down-staging and complete response for rectal adenocarcinoma after induction chemotherapy and neoadjuvant chemoradiation followed by surgery, and to analyze the rate of sphincter-saving surgery. We included from March 2011 to October 2013 a number of 88 patients hospitalized with locally advanced rectal adenocarcinoma in the Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj. The treatment schedule included 2-4 cycles of Oxaliplatin plus a fluoropyrimidine followed by concomitant chemoradiation with a dose of 50 Gy in 25 fractions combined with a fluoropyrimidine monotherapy. The rate of T down-staging was 49.4% (40/81 evaluable patients). Independent prognostic factors for T down-staging were: age >57 years (p5 cm (p35 days (p5 cm (p=0.03). Sixty-eight patients (79.1%) underwent radical surgery and among them 35 patients (51.5 %) had a sphincter saving procedure. Induction chemotherapy with neoadjuvant chemoradiation produced important down-staging in rectal adenocarcinoma. Independent prognostic factors for T down-staging were: age, cN0, distance from anal verge, initial CEA, the number of Oxaliplatin cycles and duration of radiotherapy; for complete response: cT2, initial tumor size and distance from the anal verge.

Safety and Effectiveness of Vibration Massage by Deep Oscillations: A Prospective Observational Study

Directory of Open Access Journals (Sweden)

Karin Kraft

2013-01-01

Full Text Available The objective of this study is to assess the safety of treatment with vibration massage using a deep oscillation device and the effects on symptom severity and quality of life in patients with primary fibromyalgia syndrome (FMS. Outpatients with FMS performed an observational prospective study with visits 2–4 weeks after the last treatment (control and after further 2 months (follow-up. Patients were treated with 10 sessions of 45 min deep oscillation massage, 2/week. Primary outcome parameters were safety and tolerability (5-level Likert scale (1 = very good (after each treatment session and at control visit. Secondary outcome parameters were symptom severity (Fibromyalgia Impact Questionnaire (FIQ, pain and quality of life (SF-36. Seventy patients (97.1% females were included. At control visit, 41 patients (58.6% reported 63 mild and short-lasting adverse events, mainly worsening of prevalent symptoms such as pain and fatigue. Tolerability was rated as 1.8 (95% confidence interval: 1.53; 2.07. Symptoms and quality of life were significantly improved at both control and follow-up visits (at least P<0.01. In conclusion, deep oscillation massage is safe and well tolerated in patients with FMS and might improve symptoms and quality of life rather sustained.

Knowledge and attitudes toward HPV vaccination among healthcare givers: First multicentre survey in Malaysia

Directory of Open Access Journals (Sweden)

Shabbir Ahmed Sheikh

2017-04-01

Full Text Available Background Cervical cancer is an important public health concern worldwide, and in both developed and developing countries. In Malaysia, cervical cancer is the second most common cancer in women after breast cancer and colorectal cancer. The relation between cervical cancer and oncogenic human papillomavirus (HPV infection has been well-established and it has been reported that almost all cervical cancers are correlated to oncogenic HPV DNA. Worldwide around 70 per cent of cervical cancer cases are caused by HPV type 16 and HPV type 18 and responsible for 90 per cent of penile and anal cancer in men. However, HPV type 6 and 11 cause over 90 per cent of genital warts in both men and women. Aims The objective was to assess the knowledge and attitude level among health givers and to compare among the groups. Methods This was a cross-sectional multi-centre study. Simple random sampling was adopted to collect the data. A questionnaire has been developed and it was pretested. Medical doctors and nurses of Malaysian health service were the study population. The data was evaluated with the necessary statistical tests as applicable. P-values <0.05 was considered statistically significant. Results Total participants of this study were 629. They mainly doctor and nurses. The average age was 31.68±7.20 years. Regarding HPV vaccination, their mean knowledge and attitude scores (SD were 13.32±2.30 and 9.38±1.45 respectively. Conclusion Medical doctors have statistically significantly higher knowledge and attitude scores than paramedical staff. Knowledge level was statistically significantly correlated with attitude. More in-depth prospection interventional research has been advocated to safeguard the Malaysian population from the atrocities of cervical cancer.

Morbidity and mortality in the antiphospholipid syndrome during a 10-year period: a multicentre prospective study of 1000 patients.

Science.gov (United States)

Cervera, R; Serrano, R; Pons-Estel, G J; Ceberio-Hualde, L; Shoenfeld, Y; de Ramón, E; Buonaiuto, V; Jacobsen, S; Zeher, M M; Tarr, T; Tincani, A; Taglietti, M; Theodossiades, G; Nomikou, E; Galeazzi, M; Bellisai, F; Meroni, P L; Derksen, R H W M; de Groot, P G D; Baleva, M; Mosca, M; Bombardieri, S; Houssiau, F; Gris, J-C; Quéré, I; Hachulla, E; Vasconcelos, C; Fernández-Nebro, A; Haro, M; Amoura, Z; Miyara, M; Tektonidou, M; Espinosa, G; Bertolaccini, M L; Khamashta, M A

2015-06-01

To assess the prevalence of the main causes of morbi-mortality in the antiphospholipid syndrome (APS) during a 10-year-follow-up period and to compare the frequency of early manifestations with those that appeared later. In 1999, we started an observational study of 1000 APS patients from 13 European countries. All had medical histories documented when entered into the study and were followed prospectively during the ensuing 10 years. 53.1% of the patients had primary APS, 36.2% had APS associated with systemic lupus erythematosus and 10.7% APS associated with other diseases. Thrombotic events appeared in 166 (16.6%) patients during the first 5-year period and in 115 (14.4%) during the second 5-year period. The most common events were strokes, transient ischaemic attacks, deep vein thromboses and pulmonary embolism. 127 (15.5%) women became pregnant (188 pregnancies) and 72.9% of pregnancies succeeded in having one or more live births. The most common obstetric complication was early pregnancy loss (16.5% of the pregnancies). Intrauterine growth restriction (26.3% of the total live births) and prematurity (48.2%) were the most frequent fetal morbidities. 93 (9.3%) patients died and the most frequent causes of death were severe thrombosis (36.5%) and infections (26.9%). Nine (0.9%) cases of catastrophic APS occurred and 5 (55.6%) of them died. The survival probability at 10 years was 90.7%. Patients with APS still develop significant morbidity and mortality despite current treatment. It is imperative to increase the efforts in determining optimal prognostic markers and therapeutic measures to prevent these complications. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Image acquisition and interpretation criteria for Tc-99m-HMPAO-labelled white blood cell scintigraphy : results of a multicentre study

NARCIS (Netherlands)

Erba, Paola A.; Glaudemans, Andor W. J. M.; Veltman, Niels C.; Sollini, Martina; Pacilio, Marta; Galli, Filippo; Dierckx, Rudi A. J. O.; Signore, Alberto

Purpose There is no consensus yet on the best protocol for planar image acquisition and interpretation of radiolabelled white blood cell (WBC) scintigraphy. This may account for differences in reported diagnostic accuracy amongst different centres. Methods This was a multicentre retrospective study

Multicentre survey of radiologically inserted gastrostomy feeding tube (RIG) in the UK

International Nuclear Information System (INIS)

Lowe, A.S.; Laasch, H.U.; Stephenson, S.; Butterfield, C.; Goodwin, M.; Kay, C.L.; Glancy, S.; Jackson, S.; Brown, D.; McLean, P.; Keanie, J.; Thrower, A.; Briggs, R.; Punekar, S.; Krishnan, S.; Thomas, B.; Yap, K.; Mullan, D.; Maskell, G.; Hancock, J.

2012-01-01

Aims: To evaluate the variance in current UK clinical practice and clinical outcomes for direct percutaneous radiologically inserted gastrostomy (RIG). Materials and methods: A prospective UK multicentre survey of RIG performed between October 2008 and August 2010 was performed through the British Society of Gastrointestinal and Abdominal Radiology (BSGAR). Results: Data from 684 patients were provided by 45 radiologists working at 17 UK centres. Two hundred and sixty-three cases (40%) were performed with loop-retained catheters, and 346 (53%) with balloon-retained devices. Sixty percent of all patients experienced pain in the first 24 h, but settled in the majority thereafter. Early complications, defined as occurring in the first 24 h, included minor bleeding (1%), wound infection (3%), peritonism (2%), and tube misplacement (1%). Late complications, defined as occurring between day 2 and day 30 post-procedure, included mild pain (30%), persisting peritonism (2%), and 30 day mortality of 1% (5/665). Pre-procedural antibiotics or anti-methicillin-resistant Staphylococcus aureus (MRSA) prophylaxis did not affect the rate of wound infection, peritonitis, post-procedural pain, or mortality. Ninety-three percent of cases were performed using gastropexy. Gastropexy decreased post-procedural pain (p < 0.001), but gastropexy-related complications occurred in 5% of patients. However, post-procedure pain increased with the number of gastropexy sutures used (p < 0.001). The use of gastropexy did not affect the overall complication rate or mortality. Post-procedure pain increased significantly as tube size increased (p < 0.001). The use of balloon-retention feeding tubes was associated with more pain than the deployment of loop-retention devices (p < 0.001). Conclusion: RIG is a relatively safe procedure with a mortality of 1%, with or without gastropexy. Pain is the commonest complication. The use of gastropexy, fixation dressing or skin sutures, smaller tube sizes, and

Sophia Observation withdrawal Symptoms-Paediatric Delirium scale: A tool for early screening of delirium in the PICU.

Science.gov (United States)

Ista, Erwin; Te Beest, Harma; van Rosmalen, Joost; de Hoog, Matthijs; Tibboel, Dick; van Beusekom, Babette; van Dijk, Monique

2017-08-23

Delirium in critically ill children is a severe neuropsychiatric disorder which has gained increased attention from clinicians. Early identification of delirium is essential for successful management. The Sophia Observation withdrawal Symptoms-Paediatric Delirium (SOS-PD) scale was developed to detect Paediatric Delirium (PD) at an early stage. The aim of this study was to determine the measurement properties of the PD component of the SOS-PD scale in critically ill children. A prospective, observational study was performed in patients aged 3 months or older and admitted for more than 48h. These patients were assessed with the SOS-PD scale three times a day. If the SOS-PD total score was 4 or higher in two consecutive observations, the child psychiatrist was consulted to assess the diagnosis of PD using the Diagnostic and Statistical Manual-IV criteria as the "gold standard". The child psychiatrist was blinded to outcomes of the SOS-PD. The interrater reliability of the SOS-PD between the care-giving nurse and a researcher was calculated with the intraclass correlation coefficient (ICC). A total of 2088 assessments were performed in 146 children (median age 49 months; IQR 13-140). The ICC of 16 paired nurse-researcher observations was 0.90 (95% CI 0.70-0.96). We compared 63 diagnoses of the child psychiatrist versus SOS-PD assessments in 14 patients, in 13 of whom the diagnosis of PD was confirmed. The sensitivity was 96.8% (95% CI 80.4-99.5%) and the specificity was 92.0% (95% CI 59.7-98.9%). The SOS-PD scale shows promising validity for early screening of PD. Further evidence should be obtained from an international multicentre study. Copyright © 2017 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults

DEFF Research Database (Denmark)

Klek, Stanislaw; Chambrier, Cecile; Singer, Pierre

2013-01-01

The aim of this study was to evaluate the safety and tolerance of a soybean/MCT/olive/fish oil emulsion in intestinal failure patients on long-term parenteral nutrition. 73 patients took part in a randomized, double-blind, multi-centre study. The study demonstrates that the lipid emulsion...

[Introduction of capillary glycosylated haemoglobin determination in a Primary Care Health Area: Multicentre study of the evolution of patients with type 2 diabetes mellitus].

Science.gov (United States)

Núñez-Sánchez, M Á; Cervantes-Cuesta, M Á; Brocal-Ibañez, P; Salmeron-Arjona, E; León-Martínez, L P; Cerezo-Sanmartin, M

The aim of this study was to evaluate the efficiency of a joint intervention that included educational components, self-assessment, and information to optimise diabetes control through the introduction of instant capillary glycosylated haemoglobin (HbA1c) determination in Primary Care. A multicentre prospective descriptive study was carried out over 3years in 10Primary Care Centres of the Area VII Murcia East. At the end of the study there were 804 patients with type 2 diabetes (DM2). Patients were divided into 4 groups based on initial values of HbA1c, and if changes in their treatment were needed. HbA1c, body mass index, and blood pressure were monitored. A financial assessment was also performed on the impact of the implementation of a protocol to measure instant capillary RESULTS: A significant reduction was observed in HbA1c values. The initial HbA1c mean value was 7.4±1.4%, which decreased to a final value of 6.9±1.0% (P<.001). At the end of the study, 71.4% of patients included reached diabetic control objectives. In addition, the financial assessment demonstrated that the implementation of this diabetes control system led to a decrease of the 24.7% in spending on glucose strips after the first year of study in Area VII Murcia Health Service. The introduction of capillary HbA1c determination in Primary Care has demonstrated to improve diabetes control and the efficiency of the health personnel. Furthermore, a reduction in the health costs of patients with DM2 was also shown. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: Treatment outcomes of a prospective, multicentric clinical study

International Nuclear Information System (INIS)

Wu, Fang; Wang, Rensheng; Lu, Heming; Wei, Bo; Feng, Guosheng; Li, Guisheng; Liu, Meilian; Yan, Haolin; Zhu, Jinxian; Zhang, Yong; Hu, Kai

2014-01-01

Background and purpose: To evaluate long-term outcome in locoregionally advanced nasopharyngeal carcinoma (NPC) treated with intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. Material and methods: Between January 2006 and August 2008, 249 patients with stage III–IVb NPC were treated by IMRT plus concurrent chemotherapy in this multicenter prospective study. Results: With a mean follow-up of 54.1 months, the 5-year actuarial rates of overall survival (OS), local recurrence-free survival (LRFS), regional recurrence-free survival (RRFS), and distant metastasis-free survival (DMFS) were 78.4%, 86.8%, 88.4%, 78.0%, respectively. There were 29 local recurrences, 25 regional recurrences and 52 distant metastases, respectively. Distant metastasis is the main cause of treatment failure. N-stage was an independent prognostic factor for LRFS, RRFS, DMFS and OS. Acute toxicity ⩾grade III mainly consisted of mucositis (34.9%), neutropenia (11.2%), xerostomia (5.6%), and dermatitis (5.2%). The main documented late toxicity was xerostomia, and the severity of xerostomia decreased over time. At 24 months after treatment, 13.2% of patients had grade 2 xerostomia, and none had grade 3 or 4 xerostomia. Conclusions: IMRT with concurrent cisplatin chemotherapy resulted in encouraging rates of local and distant control and overall survival with acceptable rates of acute and limited rates of late toxicity in patients with locoregionally advanced NPC. Distant metastasis remained the main cause of failure. More effective systemic therapy should be explored for patients with advanced N-stage

A multicentre audit of HDR/PDR brachytherapy absolute dosimetry in association with the INTERLACE trial (NCT015662405)

Science.gov (United States)

Díez, P.; Aird, E. G. A.; Sander, T.; Gouldstone, C. A.; Sharpe, P. H. G.; Lee, C. D.; Lowe, G.; Thomas, R. A. S.; Simnor, T.; Bownes, P.; Bidmead, M.; Gandon, L.; Eaton, D.; Palmer, A. L.

2017-12-01

A UK multicentre audit to evaluate HDR and PDR brachytherapy has been performed using alanine absolute dosimetry. This is the first national UK audit performing an absolute dose measurement at a clinically relevant distance (20 mm) from the source. It was performed in both INTERLACE (a phase III multicentre trial in cervical cancer) and non-INTERLACE brachytherapy centres treating gynaecological tumours. Forty-seven UK centres (including the National Physical Laboratory) were visited. A simulated line source was generated within each centre’s treatment planning system and dwell times calculated to deliver 10 Gy at 20 mm from the midpoint of the central dwell (representative of Point A of the Manchester system). The line source was delivered in a water-equivalent plastic phantom (Barts Solid Water) encased in blocks of PMMA (polymethyl methacrylate) and charge measured with an ion chamber at 3 positions (120° apart, 20 mm from the source). Absorbed dose was then measured with alanine at the same positions and averaged to reduce source positional uncertainties. Charge was also measured at 50 mm from the source (representative of Point B of the Manchester system). Source types included 46 HDR and PDR 192Ir sources, (7 Flexisource, 24 mHDR-v2, 12 GammaMed HDR Plus, 2 GammaMed PDR Plus, 1 VS2000) and 1 HDR 60Co source, (Co0.A86). Alanine measurements when compared to the centres’ calculated dose showed a mean difference (±SD) of  +1.1% (±1.4%) at 20 mm. Differences were also observed between source types and dose calculation algorithm. Ion chamber measurements demonstrated significant discrepancies between the three holes mainly due to positional variation of the source within the catheter (0.4%-4.9% maximum difference between two holes). This comprehensive audit of absolute dose to water from a simulated line source showed all centres could deliver the prescribed dose to within 5% maximum difference between measurement and calculation.

Cardiovascular assessment of asymptomatic patients with juvenile-onset localized and systemic scleroderma: 10 years prospective observation.

Science.gov (United States)

Borowiec, A; Dabrowski, R; Wozniak, J; Jasek, S; Chwyczko, T; Kowalik, I; Musiej-Nowakowska, E; Szwed, H

2012-02-01

The aim of the present study was non-invasive evaluation of the cardiovascular system in asymptomatic young adult patients with juvenile localized scleroderma (JLS) and juvenile systemic sclerosis (JSS). A group of 34 consecutive children with scleroderma were prospectively observed in the study. The control group (CG) consisted of 20 healthy subjects. In each subject 12-lead electrocardiographic, echocardiographic, ECG Holter, and ambulatory blood pressure monitoring examinations were performed at the baseline visit and after 10 years. Additionally, B-type natriuretic peptide (BNP) concentrations were measured after 10 years. Examinations were performed in 13 patients with JLS and 15 with JSS at the final visit. Two children had died (one from each group). Four patients were alive but refused the final visit. After 10 years, a higher prevalence of ventricular extrasystoles (p = 0.01) and an elevated pulmonary arterial pressure (JLS: p = 0.04, JSS: p = 0.03) were observed in both groups, but in comparison with the controls there was no significant difference at the final visit. In JLS patients more cases of left ventricle diastolic dysfunction, hypertension, and sinus tachycardia were diagnosed at the final visit (p ≤ 0.05). More atrioventricular block episodes in both groups of scleroderma patients were observed. Over the 10 years, arterial hypertension was diagnosed in three patients from the JLS group and in two with JSS. There were no significant differences in BNP concentrations at the final visit. The results of the present study show that juvenile scleroderma seems to be more benign than adult-onset disease. This observational study shows subclinical, not severe, cardiac abnormalities in adult patients with juvenile-onset disease.

Screening prior to biological therapy in Crohn's disease: adherence to guidelines and prevalence of infections. Results from a multicentre retrospective study

NARCIS (Netherlands)

van der Have, Mike; Belderbos, Tim D. G.; Fidder, Herma H.; Leenders, Max; Dijkstra, Gerard; Peters, Charlotte P.; Eshuis, Emma J.; Ponsioen, Cyriel Y.; Siersema, Peter D.; van Oijen, Martijn G. H.; Oldenburg, Bas

2014-01-01

Screening for opportunistic infections prior to starting biological therapy in patients with inflammatory bowel disease is recommended. To assess adherence to screening for opportunistic infections prior to starting biological therapy in Crohn's disease patients and its yield. A multicentre

The health and healthcare impact of providing insurance coverage to uninsured children: A prospective observational study

Directory of Open Access Journals (Sweden)

Glenn Flores

2017-05-01

Full Text Available Abstract Background Of the 4.8 million uninsured children in America, 62–72% are eligible for but not enrolled in Medicaid or CHIP. Not enough is known, however, about the impact of health insurance on outcomes and costs for previously uninsured children, which has never been examined prospectively. Methods This prospective observational study of uninsured Medicaid/CHIP-eligible minority children compared children obtaining coverage vs. those remaining uninsured. Subjects were recruited at 97 community sites, and 11 outcomes monitored monthly for 1 year. Results In this sample of 237 children, those obtaining coverage were significantly (P 6 months at baseline were associated with remaining uninsured for the entire year. In multivariable analysis, children who had been uninsured for >6 months at baseline (odds ratio [OR], 3.8; 95% confidence interval [CI], 1.4–10.3 and African-American children (OR, 2.8; 95% CI, 1.1–7.3 had significantly higher odds of remaining uninsured for the entire year. Insurance saved $2886/insured child/year, with mean healthcare costs = $5155/uninsured vs. $2269/insured child (P = .04. Conclusions Providing health insurance to Medicaid/CHIP-eligible uninsured children improves health, healthcare access and quality, and parental satisfaction; reduces unmet needs and out-of-pocket costs; and saves $2886/insured child/year. African-American children and those who have been uninsured for >6 months are at greatest risk for remaining uninsured. Extrapolation of the savings realized by insuring uninsured, Medicaid/CHIP-eligible children suggests that America potentially could save $8.7–$10.1 billion annually by providing health insurance to all Medicaid/CHIP-eligible uninsured children.

Real-time ultrasound-guided spinal anaesthesia: a prospective observational study of a new approach.

LENUS (Irish Health Repository)

Conroy, P H

2013-01-01

Identification of the subarachnoid space has traditionally been achieved by either a blind landmark-guided approach or using prepuncture ultrasound assistance. To assess the feasibility of performing spinal anaesthesia under real-time ultrasound guidance in routine clinical practice we conducted a single center prospective observational study among patients undergoing lower limb orthopaedic surgery. A spinal needle was inserted unassisted within the ultrasound transducer imaging plane using a paramedian approach (i.e., the operator held the transducer in one hand and the spinal needle in the other). The primary outcome measure was the success rate of CSF acquisition under real-time ultrasound guidance with CSF being located in 97 out of 100 consecutive patients within median three needle passes (IQR 1-6). CSF was not acquired in three patients. Subsequent attempts combining landmark palpation and pre-puncture ultrasound scanning resulted in successful spinal anaesthesia in two of these patients with the third patient requiring general anaesthesia. Median time from spinal needle insertion until intrathecal injection completion was 1.2 minutes (IQR 0.83-4.1) demonstrating the feasibility of this technique in routine clinical practice.

Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

Science.gov (United States)

Liu, Zongjun; Shen, Li; Huang, Weijian; Zhao, Xianxian; Fang, Weiyi; Wang, Changqian; Yin, Zhaofang; Wang, Jianan; Fu, Guosheng; Liu, Xuebo; Jiang, Jianjun; Zhang, Zhihui; Li, Jingbo; Lu, Yingmin; Ge, Junbo

2017-09-01

Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China. ClinicalTrials.gov ID: NCT02900729; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017

Problem-solving ability and repetition of deliberate self-harm: a multicentre study.

Science.gov (United States)

McAuliffe, Carmel; Corcoran, Paul; Keeley, Helen S; Arensman, Ella; Bille-Brahe, Unni; De Leo, Diego; Fekete, Sandor; Hawton, Keith; Hjelmeland, Heidi; Kelleher, Margaret; Kerkhof, Ad J F M; Lönnqvist, Jouko; Michel, Konrad; Salander-Renberg, Ellinor; Schmidtke, Armin; Van Heeringen, Kees; Wasserman, Danuta

2006-01-01

While recent studies have found problem-solving impairments in individuals who engage in deliberate self-harm (DSH), few studies have examined repeaters and non-repeaters separately. The aim of the present study was to investigate whether specific types of problem-solving are associated with repeated DSH. As part of the WHO/EURO Multicentre Study on Suicidal Behaviour, 836 medically treated DSH patients (59% repeaters) from 12 European regions were interviewed using the European Parasuicide Study Interview Schedule (EPSIS II) approximately 1 year after their index episode. The Utrecht Coping List (UCL) assessed habitual responses to problems. Factor analysis identified five dimensions--Active Handling, Passive-Avoidance, Problem Sharing, Palliative Reactions and Negative Expression. Passive-Avoidance--characterized by a pre-occupation with problems, feeling unable to do anything, worrying about the past and taking a gloomy view of the situation, a greater likelihood of giving in so as to avoid difficult situations, the tendency to resign oneself to the situation, and to try to avoid problems--was the problem-solving dimension most strongly associated with repetition, although this association was attenuated by self-esteem. The outcomes of the study indicate that treatments for DSH patients with repeated episodes should include problem-solving interventions. The observed passivity and avoidance of problems (coupled with low self-esteem) associated with repetition suggests that intensive therapeutic input and follow-up are required for those with repeated DSH.

Complete en bloc urinary exenteration for synchronous multicentric transitional cell carcinoma with sarcomatoid features in a hemodialysis patient

Directory of Open Access Journals (Sweden)

Tiberio M. Siqueira Jr

2006-10-01

Full Text Available The incidence of transitional cell carcinoma (TCC in patients submitted to hemodialysis is low. The presence of TCC with sarcomatoid features in this cohort is even scarcer. Herein, we describe a very rare case of synchronous multicentric muscle invasive bladder carcinoma with prostate invasion in a hemodialysis patient, submitted to complete en bloc urinary exenteration.

Tea consumption and risk of cardiovascular outcomes and total mortality: a systematic review and meta-analysis of prospective observational studies

International Nuclear Information System (INIS)

Zhang, Chi; Qin, Ying-Yi; Wei, Xin; Yu, Fei-Fei; Zhou, Yu-Hao; He, Jia

2015-01-01

Studies that investigated the association between tea consumption and the risk of major cardiovascular events have reported inconsistent results. We conducted a meta-analysis of prospective observational studies in order to summarize the evidence regarding the association between tea consumption and major cardiovascular outcomes or total mortality. In July 2014, we performed electronic searches in PubMed, EmBase, and the Cochrane Library, followed by manual searches of reference lists from the resulting articles to identify other relevant studies. Prospective observational studies that reported effect estimates, with 95 % confidence intervals (CIs), for coronary heart disease (CHD), stroke, cardiac death, stroke death, or total mortality for more than two dosages of tea consumption were included. A random-effects meta-analysis was performed to determine the risk of major cardiovascular outcomes associated with an increase in tea consumption by 3 cups per day. Of the 736 citations identified from database searches, we included 22 prospective studies from 24 articles reporting data on 856,206 individuals, and including 8,459 cases of CHD, 10,572 of stroke, 5,798 cardiac deaths, 2,350 stroke deaths, and 13,722 total deaths. Overall, an increase in tea consumption by 3 cups per day was associated with a reduced risk of CHD (relative risk [RR], 0.73; 95 % CI: 0.53–0.99; P = 0.045), cardiac death (RR, 0.74; 95 % CI: 0.63–0.86; P < 0.001), stroke (RR, 0.82; 95 % CI: 0.73–0.92; P = 0.001), total mortality (RR, 0.76; 95 % CI: 0.63–0.91; P = 0.003), cerebral infarction (RR, 0.84; 95 % CI: 0.72–0.98; P = 0.023), and intracerebral hemorrhage (RR, 0.79; 95 % CI: 0.72–0.87; P < 0.001), but had little or no effect on stroke mortality (RR, 0.93; 95 % CI: 0.83–1.05; P = 0.260). The findings from this meta-analysis indicate that increased tea consumption is associated with a reduced risk of CHD, cardiac death, stroke, cerebral infarction, and

Opportunities for in-depth compositional studies of comets: Summary from semester 2017A observations and prospects for a 2018 observing campaign

Science.gov (United States)

DiSanti, Michael A.; Dello Russo, Neil; Bonev, Boncho P.; Gibb, Erika L.; Roth, Nathan; Vervack, Ronald J.; McKay, Adam J.; Kawakita, Hideyo; Cochran, Anita L.

2017-10-01

The period from late 2016 to mid 2017 provided unusually rich observational opportunities for compositional studies of comets using ground-based IR and optical spectroscopy. Three ecliptic comets - Jupiter-family comet (JFC) 45P/Honda-Mrkos-Pajdusakova, JFC 41P/Tuttle-Giacobini-Kresak, and 2P/Encke - as well as two moderately bright nearly istotropic comets from the Oort cloud (C/2015 ER61 PanSTARRS and C/2015 V2 Johnson) experienced highly favorable appritions.In the IR, very long on-source integration times were accumulated on all targets, primarily with the powerful new high-resolution, cross-dispersed iSHELL spectrograph at the IRTF (Rayner et al. 2016 SPIE 9908:1) but also with NIRSPEC at Keck II. This enabled accurate production rates and abundance ratios for 8-10 native ices, and spatially resolved studies of coma physics (H2O rotational temperatures and column abundances). The recent availability of iSHELL coupled with the daytime observing capability at the IRTF has opened a powerful window for conducting detailed compositional studies of comets over a range of heliocentric distances (Rh), particularly at small Rh where studies are relatively sparse. Our campaign provided detections of (or stringent abundance limits for) hyper-volatiles CO and CH4, which are severely lacking in compositional studies of JFCs.For all of these targets, optical spectra measured photo-dissociation product species using the Tull Coude spectrograph at McDonald Observatory, and ARCES at Apache Point Observatory. When possible optical and IR observations were obtained contemporaneously, with the goal of addressing potential parent-product relationships.We summarize our campaign and highlight related presentations. Prospects for investigations during the upcoming favorable apparitions of JFCs 21P/Giacobini-Zinner and 46P/Wirtanen will also be discussed, along with increased capabilities for serial studies (i.e., measurements at multiple Rh) of newly discovered (Oort cloud) comets

Benefit of particle therapy in re-irradiation of head and neck patients. Results of a multicentric in silico ROCOCO trial

NARCIS (Netherlands)

Eekers, D.B.; Roelofs, E.; Jelen, U.; Kirk, M.; Granzier, M.; Ammazzalorso, F.; Ahn, P.H.; Janssens, G.O.; Hoebers, F.J.; Friedmann, T.; Solberg, T.; Walsh, S.; Troost, E.G.; Kaanders, J.H.A.M.; Lambin, P.

2016-01-01

BACKGROUND AND PURPOSE: In this multicentric in silico trial we compared photon, proton, and carbon-ion radiotherapy plans for re-irradiation of patients with squamous cell carcinoma of the head and neck (HNSCC) regarding dose to tumour and doses to surrounding organs at risk (OARs). MATERIAL AND

Diagnosis of prosthetic joint infection with alpha-defensin using a lateral flow device: a multicentre study.

Science.gov (United States)

Berger, P; Van Cauter, M; Driesen, R; Neyt, J; Cornu, O; Bellemans, J

2017-09-01

The purpose of this current multicentre study is to analyse the presence of alpha-defensin proteins in synovial fluid using the Synovasure lateral flow device and to determine its diagnostic reliability and accuracy compared with the prosthetic joint infection (PJI) criteria produced by the Musculoskeletal Infection Society (MSIS). A cohort of 121 patients comprising 85 total knee arthroplasties and 36 total hip arthroplasties was prospectively evaluated between May 2015 and June 2016 in three different orthopaedic centres. The tests were performed on patients with a chronically painful prosthesis undergoing a joint aspiration in a diagnostic pathway or during revision surgery. Based on the MSIS criteria, 34 patients (28%) would have had a PJI, and 87 patients had no PJI. Testing with the lateral flow device had a sensitivity of 97.1% (95% confidence intervals (CI) 84.5 to 99.9) and a specificity of 96.6% (95% CI 90.3 to 99.2). The positive predictive value was 91.7% (95% CI 77.7% to 98.3), and the negative predictive value was 98.8% (95% CI 93.6 to 99.9). Receiver operator characteristics analysis demonstrated an area under the curve for the Synovasure test of 0.97 (95% CI 0.93 to 1.00). Our findings suggest that the Synovasure test has an excellent diagnostic performance to confirm or reject the diagnosis of a PJI. The results are promising for the care of the painful or problematic knee and hip joint arthroplasty and the test should be considered as part of the diagnostic toolbox for PJIs. Cite this article: Bone Joint J 2017;99-B:1176-82. ©2017 The British Editorial Society of Bone & Joint Surgery.

The utility of e-Learning to support training for a multicentre bladder online adaptive radiotherapy trial (TROG 10.01-BOLART).

Science.gov (United States)

Foroudi, Farshad; Pham, Daniel; Bressel, Mathias; Tongs, David; Rolfo, Aldo; Styles, Colin; Gill, Suki; Kron, Tomas

2013-10-01

An e-Learning programme appeared useful for providing training and information regarding a multi-centre image guided radiotherapy trial. The aim of this study is to demonstrate the utility of this e-Learning programme. Modules were created on relevant pelvic anatomy, Cone Beam CT soft tissue recognition and trial details. Radiation therapist participants' knowledge and confidence were evaluated before, at the end of, and after at least 6 weeks of e-Learning (long term). One hundred and eighty-five participants were recruited from 12 centres, with 118 in the first, and 67 in the second cohort. One hundred and forty-six participants had two tests (pre and post e-Learning) and 39 of these had three tests (pre, post, and long term). There was an increase confidence after completion of modules (pe-Learning for a multi-centre clinical trial was feasible and improved confidence and knowledge. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Harmonization process and reliability assessment of anthropometric measurements in the elderly EXERNET multi-centre study.

Directory of Open Access Journals (Sweden)

Alba Gómez-Cabello

Full Text Available BACKGROUND: The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. PURPOSE: To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. MATERIALS AND METHODS: A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. RESULTS: For height, intra-rater technical errors of measurement (TEMs were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. CONCLUSION: The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population.

A Japanese cross-sectional multicentre study of biomarkers associated with cardiovascular disease in smokers and non-smokers

OpenAIRE

L?dicke, Frank; Magnette, John; Baker, Gizelle; Weitkunat, Rolf

2015-01-01

Abstract We performed a cross-sectional, multicentre study in Japan to detect the differences in biomarkers of exposure and cardiovascular biomarkers between smokers and non-smokers. Several clinically relevant cardiovascular biomarkers differed significantly between smokers and non-smokers, including lipid metabolism (high-density lipoprotein cholesterol concentrations ? lower in smokers), inflammation (fibrinogen and white blood cell count ? both higher in smokers), oxidative stress (8-epi-...

Perceived job insecurity, unemployment and depressive symptoms: a systematic review and meta-analysis of prospective observational studies.

Science.gov (United States)

Kim, T J; von dem Knesebeck, O

2016-05-01

It was shown that both job insecurity and unemployment are strongly and consistently associated with depressive symptoms. It is, however, less clear whether perceived job insecurity and unemployment constitute a comparable risk for the onset of depressive symptoms. A meta-analysis was conducted to explore this issue. In December 2014, relevant records were identified through the databases MEDLINE, Embase and PsychINFO. Articles were included if they had been published in the last 10 years and contained a quantitative analysis on the prospective link between job insecurity and unemployment with depressive symptoms. In 20 cohort studies within 15 articles, job insecurity and unemployment were significantly related to a higher risk of depressive symptoms, with the odds ratio (OR) being modestly higher for job insecurity (1.29, 95% CI 1.06-1.57) than for unemployment (1.19, 95% CI 1.11-1.28). Sensitivity analyses revealed that the effects were strongest in studies that examined younger respondents (unemployment ORs were higher in shorter time lags (under 1 year), while ORs for job insecurity were increased in longer exposure-outcome intervals (3-4 years). Specifically for unemployment, ORs were highest in studies that did not control for potential health selection effects and that ascertained enduring unemployment. A statistically significant publication bias was found for studies on unemployment, but not for job insecurity. The analyses revealed that both perceived job insecurity and unemployment constitute significant risks of increased depressive symptoms in prospective observational studies. By comparing both stressors, job insecurity can pose a comparable (and even modestly increased) risk of subsequent depressive symptoms.

Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

Directory of Open Access Journals (Sweden)

Amelia Scott

Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

High-dose chemoradiotherapy and watchful waiting for distal rectal cancer: a prospective observational study.

Science.gov (United States)

Appelt, Ane L; Pløen, John; Harling, Henrik; Jensen, Frank S; Jensen, Lars H; Jørgensen, Jens C R; Lindebjerg, Jan; Rafaelsen, Søren R; Jakobsen, Anders

2015-08-01

Abdominoperineal resection is the standard treatment for patients with distal T2 or T3 rectal cancers; however, the procedure is extensive and mutilating, and alternative treatment strategies are being investigated. We did a prospective observational trial to assess whether high-dose radiotherapy with concomitant chemotherapy followed by observation (watchful waiting) was successful for non-surgical management of low rectal cancer. Patients with primary, resectable, T2 or T3, N0-N1 adenocarcinoma in the lower 6 cm of the rectum were given chemoradiotherapy (60 Gy in 30 fractions to tumour, 50 Gy in 30 fractions to elective lymph node volumes, 5 Gy endorectal brachytherapy boost, and oral tegafur-uracil 300 mg/m(2)) every weekday for 6 weeks. Endoscopies and biopsies of the tumour were done at baseline, throughout the course of treatment (weeks 2, 4, and 6), and 6 weeks after the end of treatment. We allocated patients with complete clinical tumour regression, negative tumour site biopsies, and no nodal or distant metastases on CT and MRI 6 weeks after treatment to the observation group (watchful waiting). We referred all other patients to standard surgery. Patients under observation were followed up closely with endoscopies and selected-site biopsies, with surgical resection given for local recurrence. The primary endpoint was local tumour recurrence 1 year after allocation to the observation group. This study is registered with ClinicalTrials.gov, number NCT00952926. Enrolment is closed, but follow-up continues for secondary endpoints. Between Oct 20, 2009, and Dec 23, 2013, we enrolled 55 patients. Patients were recruited from three surgical units throughout Denmark and treated in one tertiary cancer centre (Vejle Hospital, Vejle, Denmark). Of 51 patients who were eligible, 40 had clinical complete response and were allocated to observation. Median follow-up for local recurrence in the observation group was 23·9 months (IQR 15·3-31·0). Local recurrence in the

Salmeterol versus slow-release theophylline combined with ketotifen in nocturnal asthma: a multicentre trial. French Multicentre Study Group.

Science.gov (United States)

Muir, J F; Bertin, L; Georges, D

1992-11-01

We wished to assess the efficacy of inhaled salmeterol (SML; 50 micrograms b.i.d.) compared to a combination of slow-release theophylline and ketotifen p.o. (TK; T 300 mg+K 1 mg b.i.d.) for the treatment of nocturnal asthma. Ninety six patients with nocturnal asthma, (forced expiratory volume in one second (FEV1) 60-90% of predicted value, reversibility > or = 15%, at least two nocturnal awakenings per week) were eligible for a multicentre, double-blind, double-dummy cross-over study (14-day run-in, two successive 28-day treatment periods). Efficacy was assessed as success/failure, success being defined as the complete disappearance of nocturnal symptoms/awakening during the last week of each treatment period. There was a statistically significant difference between SML and TK for this criterion: 46% and 39% success with SML during periods I (first 28-day period) and II (following the cross-over), compared to only 15% and 26% with TK, respectively (p < 0.01). SML was also significantly better for the other criteria (lung function, rescue salbutamol intake during day and night). Side-effects were five times less frequent in SML-treated patients (p < 0.004). Efficacy and tolerance of SML were obviously far better than those of TK in patients with nocturnal asthma.

CRRTnet: a prospective, multi-national, observational study of continuous renal replacement therapy practices.

Science.gov (United States)

Heung, Michael; Bagshaw, Sean M; House, Andrew A; Juncos, Luis A; Piazza, Robin; Goldstein, Stuart L

2017-07-06

Continuous renal replacement therapy (CRRT) is the recommended modality of dialysis for critically ill patients with hemodynamic instability. Yet there remains significant variability in how CRRT is prescribed and delivered, and limited evidence-basis to guide practice. This is a prospective, multi-center observational study of patients undergoing CRRT. Initial enrollment phase will occur at 4 academic medical centers in North America over 5 years, with a target enrollment of 2000 patients. All adult patients (18-89 years of age) receiving CRRT will be eligible for inclusion; patients who undergo CRRT for less than 24 h will be excluded from analysis. Data collection will include patient characteristics at baseline and at time of CRRT initiation; details of CRRT prescription and delivery, including machine-generated treatment data; and patient outcomes. The goal of this study is to establish a large comprehensive registry of critically ill adults receiving CRRT. Specific aims include describing variations in CRRT prescription and delivery across quality domains; validating quality measures for CRRT care by correlating processes and outcomes; and establishing a large registry for use in quality improvement and benchmarking efforts. For initial analyses, some particular areas of interest are anticoagulation protocols; approach to fluid overload; CRRT-related workload; and patient safety. Registered on ClinicalTrials.gov 1/10/2014: NCT02034448.

Respiratory Viruses in Invasively Ventilated Critically Ill Patients-A Prospective Multicenter Observational Study.

Science.gov (United States)

van Someren Gréve, Frank; Juffermans, Nicole P; Bos, Lieuwe D J; Binnekade, Jan M; Braber, Annemarije; Cremer, Olaf L; de Jonge, Evert; Molenkamp, Richard; Ong, David S Y; Rebers, Sjoerd P H; Spoelstra-de Man, Angelique M E; van der Sluijs, Koenraad F; Spronk, Peter E; Verheul, Kirsten D; de Waard, Monique C; de Wilde, Rob B P; Winters, Tineke; de Jong, Menno D; Schultz, Marcus J

2018-01-01

The presence of respiratory viruses and the association with outcomes were assessed in invasively ventilated ICU patients, stratified by admission diagnosis. Prospective observational study. Five ICUs in the Netherlands. Between September 1, 2013, and April 30, 2014, 1,407 acutely admitted and invasively ventilated patients were included. None. Nasopharyngeal swabs and tracheobronchial aspirates were collected upon intubation and tested for 14 respiratory viruses. Out of 1,407 patients, 156 were admitted because of a severe acute respiratory infection and 1,251 for other reasons (non-severe acute respiratory infection). Respiratory viruses were detected in 28.8% of severe acute respiratory infection patients and 17.0% in non-severe acute respiratory infection (p < 0.001). In one third, viruses were exclusively detected in tracheobronchial aspirates. Rhinovirus and human metapneumovirus were more prevalent in severe acute respiratory infection patients (9.6% and 2.6% vs 4.5 and 0.2%; p = 0.006 and p < 0.001). In both groups, there were no associations between the presence of viruses and the number of ICU-free days at day 28, crude mortality, and mortality in multivariate regression analyses. Respiratory viruses are frequently detected in acutely admitted and invasively ventilated patients. Rhinovirus and human metapneumovirus are more frequently found in severe acute respiratory infection patients. Detection of respiratory viruses is not associated with worse clinically relevant outcomes in the studied cohort of patients.

Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

OpenAIRE

Nauth, A. (Aaron); Creek, A.T. (Aaron T.); Zellar, A. (Abby); Lawendy, A.-R. (Abdel-Rahman); Dowrick, A. (Adam); Gupta, A. (Ajay); Dadi, A. (Akhil); Kampen, A.; Yee, A. (Albert); Vries, Alexander; de Mol van Otterloo, A. (Alexander); Garibaldi, A. (Alisha); Liew, A. (Allen); McIntyre, A.W. (Allison W.); Prasad, A.S. (Amal Shankar)

2017-01-01

textabstractBackground Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we enrolled patients aged 50 years or older with a low-energy hip fracture requiring fracture fixation from 81 clinical centres in eight countries. Patients were assigned by minimisation with a...

Results of a prospective surgical audit of bilateral paediatric cochlear implantation in the UK.

Science.gov (United States)

Broomfield, Stephen J; Murphy, John; Wild, Dominik C; Emmett, Stevan R; O'Donoghue, Gerard M

2014-09-01

Since being approved in 2009, bilateral simultaneous cochlear implantation (CI) has been the standard treatment for children in the UK who meet the criteria for CI. The aim was to report surgical outcomes of bilateral CI in the UK. Between January 2010 and December 2011, 14 UK CI centres collected data prospectively: demographics, aetiology, use of imaging, device type, surgery duration, use of intra-operative electrophysiology, length of stay, and post-operative complications. 1397 CI procedures in 961 CI recipients were included; 436 bilateral simultaneous, 394 bilateral sequential, and 131 unilateral. The majority (85%) were congenitally deaf. The commonest causes of acquired deafness were meningitis and cytomegalovirus infection. The median age for congenitally deaf bilateral simultaneous CI was 2.2 years, mean surgical duration 4.5 hours. 6.3% surgeries were day case procedures. Eight cases (2.0%) of planned bilateral CI had unilateral surgery. The overall major complication rate was 1.6% (0.9% excluding device failures), including explantation due to infection (0.2%), cerebrospinal fluid leak (0.2%), and meningitis (0.1%). There were no permanent facial nerve palsies and no deaths. Sixty-two (6.5%) immediate minor complications included 12 (1.3%) children with significant vestibular impairment. The complication rate was similar following bilateral CI compared to sequential and unilateral CI, and is comparable to other published series. This prospective multi-centre audit provides evidence that bilateral paediatric CI is a safe procedure in the UK, thus endorsing its role as a major therapeutic intervention in childhood deafness.

Optimizing the definition of intrauterine growth restriction: the multicenter prospective PORTO Study.

LENUS (Irish Health Repository)

Unterscheider, Julia

2013-04-01

The objective of the Prospective Observational Trial to Optimize Pediatric Health in Intrauterine Growth Restriction (IUGR) (PORTO Study), a national prospective observational multicenter study, was to evaluate which sonographic findings were associated with perinatal morbidity and mortality in pregnancies affected by growth restriction, originally defined as estimated fetal weight (EFW) <10th centile.

A prospective multicentric international study on the surgical outcomes and patients' satisfaction rates of the 'sliding' technique for end-stage Peyronie's disease with severe shortening of the penis and erectile dysfunction.

Science.gov (United States)

Rolle, Luigi; Falcone, Marco; Ceruti, Carlo; Timpano, Massimiliano; Sedigh, Omid; Ralph, David J; Kuehhas, Franklin; Oderda, Marco; Preto, Mirko; Sibona, Mattia; Gillo, Arianna; Garaffa, Giulio; Gontero, Paolo; Frea, Bruno

2016-05-01

To report the results from a prospective multicentric study of patients with Peyronie's disease (PD) treated with the 'sliding' technique (ST). From June 2010 to January 2014, 28 consecutive patients affected by stable PD with severe penile shortening and end-stage erectile dysfunction (ED) were enrolled in three European PD tertiary referral centres. The validated International Index of Erectile Function (IIEF) questionnaire, the Sexual Encounter Profile (SEP) Questions 2 and 3, and the Peyronie's disease questionnaire (PDQ) were completed preoperatively by all patients. At the follow-up visits (at 3, 6 and 12 months), the IIEF, the SEP Questions 2 and 3, the PDQ, and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were completed. The outcome analysis was focused on penile length restoration, and intra- and postoperative complications classified according the Clavien-Dindo Classification. The mean (range) follow-up was 37 (9-60) months. A malleable penile prosthesis (PP) was implanted in seven patients, while an inflatable three-pieces PP was placed in the remainder. In the case of inflatable PP implantation, porcine small intestinal submucosa and acellular porcine dermal matrix were used to cover the tunical defects. While in patients undergoing malleable PP implantation, collagen-fibrin sponge was used. The mean operative time was 145 min in the inflatable PP group and 115 min in the malleable PP group. There were no intraoperative complications. Postoperative complications included profuse bleeding requiring a blood transfusion in one patient (3.5%) on anticoagulation therapy for a mechanical heart valve (Grade II) and PP infection requiring the removal of the device (7%) (Grade III). There were no late recurrences of the shaft deformation. The postoperative functional data showed a progressive improvement in the score of all questionnaires, peaking at 12 months postoperatively. The mean (range) penile lengthening was 3.2 (2.5-4) cm and no

Multicentre assessment and monitored use of [18F]FDG-PET in oncology: the Spanish experience

International Nuclear Information System (INIS)

Rodriguez-Garrido, Manuel; Asensio-del-Barrio, Cristina

2008-01-01

The aim of this study was to evaluate the diagnostic effectiveness of [ 18 F]FDG-PET in oncological diseases and to assess its clinical utility and impact (on the clinical and therapeutic management of these patients). This health technology assessment was performed in Spain, using the monitored use (MU) procedure. A multicentre and prospective follow-up study was performed in a non-consecutive sample of oncological patients who were examined with PET and other conventional diagnostic tests. A protocol for this MU method (PET-MU protocol) was developed, including the three forms used to collect all the information. Enrolment of new patients began in June 2002 and continued until August 2004. A descriptive analysis and an evaluation of the diagnostic effectiveness of FDG-PET were performed. The study population comprised 2,824 oncological patients (the third form relating to follow-up was completed for only 967 of these patients) from 100 Spanish hospitals and 16 PET centres. Seventy-nine percent of cases met the clinical requirements of the PET-MU protocol. Global diagnostic parameters of PET performance and their 95% CI values were as follows: sensitivity 86% (82-89%), specificity 83% (79-86%), positive and negative predictive values 87% (83-90%) and 82% (77-85%) respectively, diagnostic accuracy 84% (82-87%) and diagnostic odds ratio 28.75 (19.75-41.84). PET detected unsuspected new lesions in 39% of patients and avoided other unnecessary diagnostic techniques and treatments in 69% of cases. In 88% of cases, PET was considered useful by the physicians who asked for the PET tests (it was deemed decisive in 30% and very useful in almost 37%). This PET-MU study has confirmed the high diagnostic effectiveness of FDG-PET for oncological indications and demonstrates that it has a great influence on the clinical and therapeutic management of patients. (orig.)

TAFRO syndrome: New subtype of idiopathic multicentric Castleman disease

Directory of Open Access Journals (Sweden)

Gordan Srkalovic

2017-05-01

Full Text Available Castleman disease (CD describes a group of three rare and poorly understood lymphoproliferative disorders that have heterogeneous clinical symptoms and common lymph node histopathological features. Unicentric CD (UCD involves a single region of enlarged nodes. Multicentric CD (MCD involves multiple regions of enlarged lymph nodes, constitutional symptoms, and organ dysfunction due to a cytokine storm often including interleukin 6. MCD is further divided into Human Herpes Virus-8 (HHV-8-associated MCD, which occurs in immunocompromised individuals, and HHV-8-negative/idiopathic MCD (iMCD. Recently, iMCD has been further sub-divided into patients with TAFRO syndrome, which involves thrombocytopenia (T, anasarca (A, fevers (F, reticulin myelofibrosis (R, organomegaly (O, and normal or only slightly elevated immunoglobulin levels, and those who do not have TAFRO syndrome. Non-TAFRO iMCD patients typically have thrombocytosis, less severe fluid accumulation, and hypergammaglobulinemia. iMCD patients with TAFRO syndrome may have a worse prognosis, but more research is needed.

'Away Days' in multi-centre randomised controlled trials: a questionnaire survey of their use and a case study on the effect of one Away Day on patient recruitment.

Science.gov (United States)

Jefferson, Laura; Cook, Liz; Keding, Ada; Brealey, Stephen; Handoll, Helen; Rangan, Amar

2015-11-06

'Away Days' (trial promotion and training events for trial site personnel) are a well-established method used by trialists to encourage engagement of research sites in the recruitment of patients to multi-centre randomised controlled trials (RCTs). We explored the use of Away Days in multi-centre RCTs and analysed the effect on patient recruitment in a case study. Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multi-centre pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients. A total of 94 people responded to the survey. The majority (78%), who confirmed had organised an Away Day previously, found them to be useful. This is despite their costs.. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites. Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multi-centre surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Inter-observer variability in contouring the penile bulb on CT images for prostate cancer treatment planning

International Nuclear Information System (INIS)

Perna, Lucia; Cozzarini, Cesare; Maggiulli, Eleonora; Fellin, Gianni; Rancati, Tiziana; Valdagni, Riccardo; Vavassori, Vittorio; Villa, Sergio; Fiorino, Claudio

2011-01-01

Several investigations have recently suggested the existence of a correlation between the dose received by the penile bulb (PB) and the risk of erectile dysfunction (ED) after radical radiotherapy for clinically localized prostate carcinoma. A prospective multi-Institute study (DUE-01) was implemented with the aim to assess the predictive parameters of ED. Previously, an evaluation of inter-observer variations of PB contouring was mandatory in order to quantify its impact on PB dose-volume parameters by means of a dummy run exercise. Fifteen observers, from different Institutes, drew the PB on the planning CT images of ten patients; inter-observer variations were analysed in terms of PB volume variation and cranial/caudal limits. 3DCRT treatment plans were simulated to evaluate the impact of PB contouring inter-variability on dose-volume statistics parameters. For DVH analysis the values of PB mean dose and the volume of PB receiving more than 50 Gy and 70 Gy (V50 and V70, respectively) were considered. Systematic differences from the average values were assessed by the Wilcoxon test. Seven observers systematically overestimated or underestimated the PB volume with deviations from the average volumes ranging between -48% and +34% (p < 0.05). The analysis of the cranial and caudal borders showed a prevalence of random over systematic deviations. Inter-observer contouring variability strongly impacts on DVH parameters, although standard deviations of inter-patient differences were larger than inter-observer variations: 14.5 Gy versus 6.8 Gy for mean PB dose, 23.0% versus 11.0% and 16.8% versus 9.3% for V50 and V70 respectively. In conclusion, despite the large inter-observer variation in contouring PB, a large multi-centric study may have the possibility to detect a possible correlation between PB % dose-volume parameters and ED. The impact of contouring uncertainty could be reduced by 'a posteriori' contouring from a single observer or by introducing

A prospective randomised multi-centre study of the impact of Ga-68 PSMA-PET/CT imaging for staging high risk prostate cancer prior to curative-intent surgery or radiotherapy (proPSMA study): clinical trial protocol.

Science.gov (United States)

Hofman, Michael S; Murphy, Declan G; Williams, Scott G; Nzenza, Tatenda; Herschtal, Alan; De Abreu Lourenco, Richard; Bailey, Dale L; Budd, Ray; Hicks, Rodney J; Francis, Roslyn J; Lawrentschuk, Nathan

2018-05-03

Accurate staging of patients with prostate cancer is important for therapeutic decision making. Relapse following surgery or radiotherapy of curative intent is not uncommon and, in part, represents a failure of staging with current diagnostic imaging techniques to detect disease spread. Prostate-specific-membrane-antigen (PSMA) positron emission tomography / computed tomography (PET/CT) is a new whole body scanning technique that enables visualisation of prostate cancer with high contrast. The hypotheses of this study are that (a) PSMA-PET/CT has improved diagnostic performance compared to conventional imaging, (b) PSMA-PET/CT should be used as a first-line diagnostic test for staging, (c) the improved diagnostic performance of PSMA-PET/CT will result in significant management impact and (d) there are economic benefits if PSMA-PET/CT is incorporated into the management algorithm. This is a prospective, multi-centre study in which patients with untreated high-risk prostate cancer will be randomised to Gallium-68-PSMA11-PET/CT or conventional imaging, consisting of computer tomography of the abdomen/pelvis and bone scintigraphy with SPECT/CT. Inclusion criteria are newly diagnosed prostate cancer patients with select high-risk prostate cancer defined as International Society of Urological Pathology (ISUP) grade group ≥ 3 (primary Gleason grade 4, or any Gleason grade 5), PSA ≥ 20ng/mL or clinical stage ≥ T3. Patients with negative, equivocal or oligometastatic disease on first line-imaging will cross-over to receive the other imaging arm. The primary objective is to compare the accuracy of PSMA-PET/CT to conventional imaging for detecting nodal or distant metastatic disease. Histopathologic, imaging and clinical follow-up at six months will define the primary endpoint according to a pre-defined scoring system. Secondary objectives include comparing management impact, the number of equivocal studies, the incremental value of second-line imaging in patients who

Multicentre validation of 4-well azole agar plates as a screening method for detection of clinically relevant azole-resistant Aspergillus fumigatus

DEFF Research Database (Denmark)

Arendrup, Maiken Cavling; Verweij, Paul E; Mouton, Johan W

2017-01-01

Objectives: Azole-resistant Aspergillus fumigatus is emerging worldwide. Reference susceptibility testing methods are technically demanding and no validated commercial susceptibility tests for moulds currently exist. In this multicentre study a 4-well azole-containing screening agar method...... following E.Def 9.3. In-house and commercial 4-well plates containing agars supplemented with 4 mg/L itraconazole, 1 mg/L voriconazole, 0.5 mg/L posaconazole and no antifungal, respectively, were evaluated. Growth was scored (0-3) by two independent observers in three laboratories. Inter-plate, inter...... agreement (no growth versus growth) was excellent (median 95%-100%, range 87%-100%, overall). The overall sensitivity and specificity for the 4-well plate (no growth versus growth) was 99% (range 97%-100%) and 99% (95%-100%), respectively. The sensitivity for simulated WT/mutant specimens was 94% (range 83...

Airway management by physician-staffed Helicopter Emergency Medical Services - a prospective, multicentre, observational study of 2,327 patients.

Science.gov (United States)

Sunde, Geir Arne; Heltne, Jon-Kenneth; Lockey, David; Burns, Brian; Sandberg, Mårten; Fredriksen, Knut; Hufthammer, Karl Ove; Soti, Akos; Lyon, Richard; Jäntti, Helena; Kämäräinen, Antti; Reid, Bjørn Ole; Silfvast, Tom; Harm, Falko; Sollid, Stephen J M

2015-08-07

Despite numerous studies on prehospital airway management, results are difficult to compare due to inconsistent or heterogeneous data. The objective of this study was to assess advanced airway management from international physician-staffed helicopter emergency medical services. We collected airway data from 21 helicopter emergency medical services in Australia, England, Finland, Hungary, Norway and Switzerland over a 12-month period. A uniform Utstein-style airway template was used for collecting data. The participating services attended 14,703 patients on primary missions during the study period, and 2,327 (16 %) required advanced prehospital airway interventions. Of these, tracheal intubation was attempted in 92 % of the cases. The rest were managed with supraglottic airway devices (5 %), bag-valve-mask ventilation (2 %) or continuous positive airway pressure (0.2 %). Intubation failure rates were 14.5 % (first-attempt) and 1.2 % (overall). Cardiac arrest patients showed significantly higher first-attempt intubation failure rates (odds ratio: 2.0; 95 % CI: 1.5-2.6; p < 0.001) compared to non-cardiac arrest patients. Complications were recorded in 13 %, with recognised oesophageal intubation being the most frequent (25 % of all patients with complications). For non-cardiac arrest patients, important risk predictors for first-attempt failure were patient age (a non-linear association) and administration of sedatives (reduced failure risk). The patient's sex, provider's intubation experience, trauma type (patient category), indication for airway intervention and use of neuromuscular blocking agents were not risk factors for first-attempt intubation failure. Advanced airway management in physician-staffed prehospital services was performed frequently, with high intubation success rates and low complication rates overall. However, cardiac arrest patients showed significantly higher first-attempt failure rates compared to non-cardiac arrest patients. All failed intubations were handled successfully with a rescue device or surgical airway. www.clinicaltrials.gov NCT01502111 . Registered 22 December 2011.

The African Lupus Genetics Network (ALUGEN) registry: standardized, prospective follow-up studies in African patients with systemic lupus erythematosus.

Science.gov (United States)

Hodkinson, B; Mapiye, D; Jayne, D; Kalla, A; Tiffin, N; Okpechi, I

2016-03-01

The prevalence and severity of systemic lupus erythematosus (SLE) differs between ethnic groups and geographical regions. Although initially reported as rare, there is growing evidence that SLE is prevalent and runs a severe course in Africa. There is a paucity of prospective studies on African SLE patients. The African Lupus Genetics Network (ALUGEN) is a multicentred framework seeking to prospectively assess outcomes in SLE patients in Africa. Outcomes measured will be death, hospital admission, disease activity flares, and SLE-related damage. We will explore predictors for these outcomes including clinical, serological, socio-demographic, therapeutic and genetic factors. Further, we will investigate comorbidities and health-related quality of life amongst these patients. Data of patients recently (≤ 5 yrs) diagnosed with SLE will be collected at baseline and annual follow-up visits, and captured electronically. The ALUGEN project will facilitate standardized data capture for SLE cases in Africa, allowing participating centres to develop their own SLE registries, and enabling collaboration to enrich our understanding of inter-ethnic and regional variations in disease expression. Comprehensive, high-quality multi-ethnic data on African SLE patients will expand knowledge of the disease and inform clinical practice, in addition to augmenting research capacity and networking links and providing a platform for future biomarker and interventional studies. © The Author(s) 2015.

Prospective SAH Study in Japan, 2005(Prospective SAH Study)

OpenAIRE

塩川, 芳昭; 栗田, 浩樹; 藤井, 清孝; Yoshiaki, SHIOKAWA; Hiroki, KURITA; Kiyotaka, FUJII; 杏林大学脳神経外科; 杏林大学脳神経外科; 北里大学脳神経外科; Department of Neurosurgery, Kyorin University School of Medicine; Department of Neurosurgery, Kyorin University School of Medicine

2009-01-01

To clarify current treatment status of ruptured cerebral aneurysms in Japan, a prospective multicenter observational study on the treatment results for aneurysmal subarachnoid hemorrhage was conducted over calendar year 2005 and final 1-year outcomes were collected. Studied centers were selected from among institutes of committee member of Japanese stroke surgery organization or symposium of vasospasm in Japan. A total of 927 patients were enrolled in this study and treatment policies were le...

The role of dosimetry audit in lung SBRT multi-centre clinical trials.

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Clark, Catharine H; Hurkmans, Coen W; Kry, Stephen F

2017-12-01

Stereotactic Body Radiotherapy (SBRT) in the lung is a challenging technique which requires high quality clinical trials to answer the un-resolved clinical questions. Quality assurance of these clinical trials not only ensures the safety of the treatment of the participating patients but also minimises the variation in treatment, thus allowing the lowest number of patient treatments to answer the trial question. This review addresses the role of dosimetry audits in the quality assurance process and considers what can be done to ensure the highest accuracy of dose calculation and delivery and it's assessment in multi-centre trials. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857).

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Mistiaen, Patriek; Achterberg, Wilco; Ament, Andre; Halfens, Ruud; Huizinga, Janneke; Montgomery, Ken; Post, Henri; Francke, Anneke L

2008-01-07

Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-)effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.

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Park, Won; Hrycaj, Pawel; Jeka, Slawomir; Kovalenko, Volodymyr; Lysenko, Grygorii; Miranda, Pedro; Mikazane, Helena; Gutierrez-Ureña, Sergio; Lim, MieJin; Lee, Yeon-Ah; Lee, Sang Joon; Kim, HoUng; Yoo, Dae Hyun; Braun, Jürgen

2013-10-01

To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS). Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed. Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively. The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.

HPV and cofactors for invasive cervical cancer in Morocco: a multicentre case-control study.

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Berraho, Mohamed; Amarti-Riffi, Afaf; El-Mzibri, Mohammed; Bezad, Rachid; Benjaafar, Noureddine; Benideer, Abdelatif; Matar, Noureddine; Qmichou, Zinab; Abda, Naima; Attaleb, Mohammed; Znati, Kaoutar; El Fatemi, Hind; Bendahhou, Karima; Obtel, Majdouline; Filali Adib, Abdelhai; Mathoulin-Pelissier, Simone; Nejjari, Chakib

2017-06-20

Limited national information is available in Morocco on the prevalence and distribution of HPV-sub-types of cervical cancer and the role of other risk factors. The aim was to determine the frequency of HPV-sub-types of cervical cancer in Morocco and investigate risk factors for this disease. Between November 2009 and April 2012 a multicentre case-control study was carried out. A total of 144 cases of cervical cancer and 288 age-matched controls were included. Odds-ratios and corresponding confidence-intervals were computed by conditional logistic regression models. Current HPV infection was detected in 92.5% of cases and 13.9% of controls. HPV16 was the most common type for both cases and controls. Very strong associations between HPV-sub-types and cervical cancer were observed: total-HPV (OR = 39), HPV16 (OR = 49), HPV18 (OR = 31), and multiple infections (OR = 13). Education, high parity, sexual intercourse during menstruation, history of sexually transmitted infections, and husband's multiple sexual partners were also significantly associated with cervical cancer in the multivariate analysis. Our results could be used to establish a primary prevention program and to prioritize limited screening to women who have specific characteristics that may put them at an increased risk of cervical cancer.

A multicentre prospective randomised study of single-incision mini-sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the management of female stress urinary incontinence: pain profile and short-term outcomes.

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Mostafa, Alyaa; Agur, Wael; Abdel-All, Mohamed; Guerrero, Karen; Lim, Chi; Allam, Mohamed; Yousef, Mohamed; N'Dow, James; Abdel-fattah, Mohamed

2012-11-01

To compare the postoperative pain profile, peri-operative details, and short-term patient-reported and objective success rates of single-incision mini-slings (SIMS) versus standard mid-urethral slings (SMUS). In a multicentre prospective randomised trial in six UK centres in the period between October 2009 and October 2010, 137 women were randomised to either adjustable SIMS (Ajust®, C. R. Bard Inc., NJ, USA), performed under local anaesthesia as an opt-out policy (n=69), or SMUS (TVT-O™, Ethicon Inc., Somerville, USA) performed under general anaesthesia (n=68). Randomisation was done through number-allocation software and using telephone randomisation. Postoperative pain profile (primary outcome) was assessed on a ten-point visual analogue scale at fixed time-points. Pre- and post operatively (4-6 months) women completed symptom severity, urgency perception scale (UPS), quality of life and sexual function questionnaires. In addition, women completed a Patient Global Impression of Improvement Questionnaire and underwent a cough stress test at 4-6 months follow up. Sample size calculation was performed and data were analysed using SPSS 18. Descriptive analyses are given and between-group comparisons were performed using chi-square, Fischer exact test and Mann-Whitney test as appropriate. Significance level was set at 5%. Women in the SIMS Ajust® group had a significantly lower postoperative pain profile up to 4 weeks (p=TVT-O™ groups respectively. There was a trend towards higher rates of de novo urgency or worsening of pre-existing urgency in the SIMS Ajust® group (21.7% versus 8.8%) but this did not reach statistical significance (p=0.063). Women in the SIMS Ajust® group had shorter hospital stay (median (IQR) 3.65 (2.49, 4.96)) compared to (4.42 (3.16, 5.56)) the TVT-O™ group 95% CI (-0.026, 1.326), with significantly earlier return to normal activities (p=0.025) and to work (p=0.006). The adjustable single-incision mini-sling (Ajust®) is associated

Fingolimod Treatment in Relapsing-Remitting Multiple Sclerosis Patients: A Prospective Observational Multicenter Postmarketing Study

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Rocco Totaro

2015-01-01

Full Text Available Objective. The aim of this prospective observational multicenter postmarketing study was to evaluate fingolimod efficacy in a real world clinical setting. Methods. One hundred forty-two subjects with relapsing-remitting multiple sclerosis (RRMS were enrolled in three multiple sclerosis centers throughout Central and Southern Italy between January 2011 and September 2013. After enrollment, regular visits and EDSS assessment were scheduled every 3 months, and MRI scan was obtained every 12 months. Patients were followed up from 1 to 33 months (mean 14.95 ± 9.15 months. The main efficacy endpoints included the proportion of patients free from clinical relapses, from disability progression, from magnetic resonance imaging activity, and from any disease activity. Results. Out of 142 patients enrolled in the study, 88.1% were free from clinical relapse and 69.0% were free from disability progression; 68.5% of patients remained free from new or newly enlarging T2 lesions and 81.7% of patients were free from gadolinium enhancing lesions. Overall the proportion of patients free from any disease activity was 41.9%. Conclusions. Our data in a real world cohort are consistent with previous findings that yield convincing evidence for the efficacy of fingolimod in patients with RRMS.

Multicentre epidemiological survey on the incidence of Streptococcus agalactiae in pregnancy

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Leonardo Lodolo

2010-03-01

Full Text Available ß-hemolytic streptococci group B (GBS cause infections of the urinary tract, endometrium, amnion, and superinfection of wounds, with complications in 2% -4% of cases in pregnant woman.The infection transmitted to newborns is a cause of sepsis and meningitis with high incidence of mortality.A recent report on a multicentric study of the ISS, showed that detection of S. agalactiae in pregnant women in different realities of healthcare, ranging from 3.9% to 19.4%. This survey covers a sample of 29607 women screened in a total of 36852 childbirths, with a positivity of 4183 subjects equal to 14.1%. Thanks to the GBS Study Group of Piemonte and Valle d’Aosta microbiology laboratories, with the support of 42 study centres have been involved. Collection techniques, types of medium, environmental of incubation of the culture, possible enrichment in broth, of the swabs of 28491 women during 2006/2007 have been considered. 24.36% were vaginal swab while 75.64% vagino/rectal. According to data collected at 31 centers with eligible data (22,175 pregnant GBS positivity was 12.7% (CI [Confidence Interval] + / -95%: 13.1% -12.2% with wide variability between individual centers (2% -22.6%. The enrichment broth is used by 6 out of 9 centers with positivity> 15% (M: 20.05%, from 6 to 14 with positivity between 10-15% (M: 12.61%, from none to 8 centers with less than 10% positivity (M: 4.95%.This multicentre survey underlined the preference for vagino/rectal swab, as recommended by the literature. The frequency of GBS positivity of pregnant women on the whole samples is similar to that found in other national surveys, even if with large differences between the different centers.The sensitivity tends to increase with the use of enrichment techniques, whose use is uneven between the centers, perhaps indicating the need for greater uniformity of protocols based on the results of microbiological analysis EBM (Evidence Based Medicine.

[Changes in quality of life and work function during phase prophylactic lamotrigine treatment in bipolar patients: 6 month, prospective, observational study].

Science.gov (United States)

Gonda, Xenia; Kalman, Janos; Dome, Peter; Rihmer, Zoltan

2016-03-01

Bipolar disorder is a lifelong illness requiring lifelong pharmacotherapy. Therefore besides symptomatic remission, achievement of full work-related functioning and restoration of quality of life is a priority during successful treatment. The present prospective, observational, non-intervention study focused on investigating the effect of lamotrigine therapy on the quality of life and work-related function of bipolar patients in outpatient care. 969 bipolar or schizoaffective outpatients participated in the study who previously did not receive lamotrigine therapy. Our present phase-prophylactic study was a prospective, observational, non-intervention study with a six-month follow-up. Evaluations took place at baseline and at months 1, 2, 3 and 6. Patients were followed with a Clinical Global Impression-Severity (CGI-S) and Clinical Global Impression-Improvement (CGI-I). Changes in work-related function was evaluated using Social Adjustment Scale (SAS), while quality of life was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) scale. SAS scoreds showed a consistent decrease in the overall sample and in all CGI-S initial groups reflecting the improvement of work-related function during the six months of the follow-up. Q-LES-Q values in the whole sample and in all initial CGI-S groups showed a steady increase indicating a continuous increase in quality of life during the study. Our results indicate that during long-term prophylactic lamotrigine therapy the work function and quality of life of bipolar patients shows a significant improvement, therefore lamotrigine provides a possibility for full functional remission and restoration of quality of life.

Species distribution and susceptibility profile to fluconazole, voriconazole and MXP-4509 of 551 clinical yeast isolates from a Romanian multi-centre study

NARCIS (Netherlands)

Minea, B; Nastasa, V; Moraru, R F; Kolecka, A; Flonta, M M; Marincu, I; Man, A; Toma, F; Lupse, M; Doroftei, B; Marangoci, N; Pinteala, M; Boekhout, T; Mares, M

This is the first multi-centre study regarding yeast infections in Romania. The aim was to determine the aetiological spectrum and susceptibility pattern to fluconazole, voriconazole and the novel compound MXP-4509. The 551 isolates were identified using routine laboratory methods, matrix-assisted

The predictive value of treatment response using FDG PET performed on day 21 of chemoradiotherapy in patients with oesophageal squamous cell carcinoma. A prospective, multicentre study (RTEP3)

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Palie, Odre; Vera, Pierre [Henri Becquerel Cancer Center and Rouen University Hospital, and QuantIF - LITIS (EA 4108), University of Rouen, Department of Nuclear Medicine, Faculty of Medicine, Rouen (France); Michel, Pierre; Di Fiore, Frederic [Rouen University Hospital and University of Rouen, Digestive Oncology Unit, Hepatogastroenterology Department, Rouen (France); Menard, Jean-Francois [Rouen University Hospital and University of Rouen, Department of Biostatistic, Rouen (France); Rousseau, Caroline; Bridji, Boumediene [Department of Nuclear Medicine, Renee Gauducheau Cancer Center, Nantes (France); Rio, Emmanuel [Department of Radiotherapy, Renee Gauducheau Cancer Center, Nantes (France); Benyoucef, Ahmed [Department of Radiotherapy, Henri Becquerel Cancer Center, Rouen (France); Meyer, Marc-Etienne [Amiens University Hospital, Department of Nuclear Medicine, Amiens (France); Jalali, Khadija [Amiens University Hospital, Department of Radiotherapy, Amiens (France); Bardet, Stephane [Department of Nuclear Medicine, Francois Baclesse Cancer Center, Caen (France); M' Vondo, Che Mabubu [Department of radiotherapy, Francois Baclesse Cancer Center, Caen (France); Olivier, Pierre [Brabois University Hospital, Department of Nuclear Medicine, Nancy (France); Faure, Guillaume [Department of Radiotherapy, Centre prive de Radiotherapie de Metz, Metz (France); Itti, Emmanuel [Henri Mondor University Hospital, Department of Nuclear Medicine, Creteil (France); Diana, Christian [Henri Mondor University Hospital, Department of Radiotherapy, Creteil (France); Houzard, Claire [Department of Nuclear Medicine, Hospices Civils de Lyon, Lyon (France); Mornex, Francoise [Department of Radiotherapy, Hospices Civils de Lyon, Lyon (France)

2013-09-15

as TV{sub p} (p = 0.02); TV{sub 40} did not decrease significantly. With respect to the predictive value of PET{sub 1}, only TV{sub 40} {sub 1} and TV{sub p} {sub 1} values, and therefore TLG{sub 40} {sub 1} and TLG{sub p} {sub 1}, but not the SUV values, were significantly lower in patients with CR at 3 months. SUVmax{sub 1}, TV{sub p} {sub 1} and TLG{sub p} {sub 1} were significantly lower in patients with CR at 1 year. With respect to the predictive value of PET{sub 2}, only TV{sub 40} {sub 2} and TV{sub p} {sub 2} values, and therefore TLG{sub 40} {sub 2} and TLG{sub p} {sub 2}, but not the SUV values, were significantly lower in patients with CR at 3 months. None of the PET{sub 2} parameters had significant value in predicting patient outcome at 1 year. The changes in SUVmax, TV{sub 40}, TV{sub p}, TLG{sub 40} and TLG{sub p} between PET{sub 1} and PET{sub 2} had no relationship to patient outcome at 3 months or 1 year. This prospective, multicentre study performed in a selected population of patients with oesophageal squamous cell cancer demonstrates that the parameters derived from baseline PET{sub 1} are good predictors of response to CRT. Specifically, a high TV and TLG are associated with a poor response to CRT at 3 months and 1 year, and a high SUVmax is associated with a poor response to CRT at 1 year. FDG PET performed during CRT on day 21 appears to have less clinical relevance. However, patients with a large functional TV on day 21 of CRT have a poor clinical outcome (ClinicalTrials.gov NCT 00934505). (orig.)

Febrile urinary tract infection after pediatric kidney transplantation: a multicenter, prospective observational study.

Science.gov (United States)

Weigel, Friederike; Lemke, Anja; Tönshoff, Burkhard; Pape, Lars; Fehrenbach, Henry; Henn, Michael; Hoppe, Bernd; Jungraithmayr, Therese; Konrad, Martin; Laube, Guido; Pohl, Martin; Seeman, Tomáš; Staude, Hagen; Kemper, Markus J; John, Ulrike

2016-06-01

Febrile urinary tract infections (fUTIs) are common after kidney transplantation (KTx); however, prospective data in a multicenter pediatric cohort are lacking. We designed a prospective registry to record data on fUTI before and after pediatric KTx. Ninety-eight children (58 boys and 40 girls) ≤ 18 years from 14 mid-European centers received a kidney transplant and completed a 2-year follow-up. Posttransplant, 38.7% of patients had at least one fUTI compared with 21.4% before KTx (p = 0.002). Before KTx, fUTI was more frequent in patients with congenital anomalies of kidneys and urinary tract (CAKUT) vs. patients without (38% vs. 12%; p = 0.005). After KTx, fUTI were equally frequent in both groups (48.7% vs. 32.2%; p = 0.14). First fUTI posttransplant occurred earlier in boys compared with girls: median range 4 vs. 13.5 years (p = 0.002). Graft function worsened (p pediatric KTx, which is not restricted to patients with CAKUT; fUTIs have a negative impact on graft function during the infectious episode but not on 2-year graft outcome.

Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case–control study in the UK

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Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

2014-01-01

Objective Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the UK in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. Design A prospective multicentre case–control study was conducted at six UK hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Methods Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Results Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. Conclusions This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. PMID:24687130

Coffee, tea and melanoma risk: findings from the European Prospective Investigation into Cancer and Nutrition.

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Caini, Saverio; Masala, Giovanna; Saieva, Calogero; Kvaskoff, Marina; Savoye, Isabelle; Sacerdote, Carlotta; Hemmingsson, Oskar; Hammer Bech, Bodil; Overvad, Kim; Tjønneland, Anne; Petersen, Kristina E N; Mancini, Francesca Romana; Boutron-Ruault, Marie-Christine; Cervenka, Iris; Kaaks, Rudolf; Kühn, Tilman; Boeing, Heiner; Floegel, Anna; Trichopoulou, Antonia; Valanou, Elisavet; Kritikou, Maria; Tagliabue, Giovanna; Panico, Salvatore; Tumino, Rosario; Bueno-de-Mesquita, H B As; Peeters, Petra H; Veierød, Marit B; Ghiasvand, Reza; Lukic, Marko; Quirós, José Ramón; Chirlaque, Maria-Dolores; Ardanaz, Eva; Salamanca Fernández, Elena; Larrañaga, Nerea; Zamora-Ros, Raul; Maria Nilsson, Lena; Ljuslinder, Ingrid; Jirström, Karin; Sonestedt, Emily; Key, Timothy J; Wareham, Nick; Khaw, Kay-Tee; Gunter, Marc; Huybrechts, Inge; Murphy, Neil; Tsilidis, Konstantinos K; Weiderpass, Elisabete; Palli, Domenico

2017-05-15

In vitro and animal studies suggest that bioactive constituents of coffee and tea may have anticarcinogenic effects against cutaneous melanoma; however, epidemiological evidence is limited to date. We examined the relationships between coffee (total, caffeinated or decaffeinated) and tea consumption and risk of melanoma in the European Prospective Investigation into Cancer and Nutrition (EPIC). EPIC is a multicentre prospective study that enrolled over 500,000 participants aged 25-70 years from ten European countries in 1992-2000. Information on coffee and tea drinking was collected at baseline using validated country-specific dietary questionnaires. We used adjusted Cox proportional hazards regression models to calculate hazard ratios (HR) and 95% confidence intervals (95% CI) for the associations between coffee and tea consumption and melanoma risk. Overall, 2,712 melanoma cases were identified during a median follow-up of 14.9 years among 476,160 study participants. Consumption of caffeinated coffee was inversely associated with melanoma risk among men (HR for highest quartile of consumption vs. non-consumers 0.31, 95% CI 0.14-0.69) but not among women (HR 0.96, 95% CI 0.62-1.47). There were no statistically significant associations between consumption of decaffeinated coffee or tea and the risk of melanoma among both men and women. The consumption of caffeinated coffee was inversely associated with melanoma risk among men in this large cohort study. Further investigations are warranted to confirm our findings and clarify the possible role of caffeine and other coffee compounds in reducing the risk of melanoma. © 2017 UICC.

Comparison of dynamic monitoring strategies based on CD4 cell counts in virally suppressed, HIV-positive individuals on combination antiretroviral therapy in high-income countries: a prospective, observational study

NARCIS (Netherlands)

Caniglia, Ellen C.; Cain, Lauren E.; Sabin, Caroline A.; Robins, James M.; Logan, Roger; Abgrall, Sophie; Mugavero, Michael J.; Hernández-Díaz, Sonia; Meyer, Laurence; Seng, Remonie; Drozd, Daniel R.; Seage, George R.; Bonnet, Fabrice; Dabis, Francois; Moore, Richard D.; Reiss, Peter; van Sighem, Ard; Mathews, William C.; del Amo, Julia; Moreno, Santiago; Deeks, Steven G.; Muga, Roberto; Boswell, Stephen L.; Ferrer, Elena; Eron, Joseph J.; Napravnik, Sonia; Jose, Sophie; Phillips, Andrew; Justice, Amy C.; Tate, Janet P.; Gill, John; Pacheco, Antonio; Veloso, Valdilea G.; Bucher, Heiner C.; Egger, Matthias; Furrer, Hansjakob; Porter, Kholoud; Touloumi, Giota; Crane, Heidi; Miro, Jose M.; Sterne, Jonathan A.; Costagliola, Dominique; Saag, Michael; Hernán, Miguel A.

2017-01-01

Clinical guidelines vary with respect to the optimal monitoring frequency of HIV-positive individuals. We compared dynamic monitoring strategies based on time-varying CD4 cell counts in virologically suppressed HIV-positive individuals. In this observational study, we used data from prospective

Effects of Ramadan fasting on moderate to severe chronic kidney disease. A prospective observational study.

Science.gov (United States)

Bakhit, Amaar A; Kurdi, Amr M; Wadera, Junaid J; Alsuwaida, Abdulkareem O

2017-01-01

To examin the effect of Ramadan fasting on worsening of renal function (WRF). Method: This was a single-arm prospective observational study including 65 patients with stage 3 or higher chronic kidney disease (CKD). By definition, WRF was considered to have occurred when serum creatinine levels increased by 0.3 mg/dL (26.5 µmol/l) from baseline during or within 3 months after Ramadan. The study was conducted in the Nephrology Clinic of King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia during the month of Ramadan 1436 AH (Hijiri), which corresponded to June 18-July 17, 2015.  Results: This study included 65 adults with a mean age of 53 years. Overall, 33% of patients developed WRF. In the multivariate analysis, more advanced CKD stage, higher baseline systolic blood pressure and younger age were independently associated with WRF. Underlying cause of CKD, use of diuretics, use of renin angiotensin blockers, gender, and smoking status were not associated with WRF.  Conclusion: In patients with stage 3 or higher CKD, Ramadan fasting during the summer months was associated with worsening of renal function. Clinicians need to warn CKD patients against Ramadan fasting.

Implementation of a mechanical CPR device in a physician staffed HEMS - a prospective observational study.

Science.gov (United States)

Rauch, Simon; Strapazzon, Giacomo; Brodmann, Monika; Fop, Ernst; Masoner, Christian; Rauch, Lydia; Forti, Alessandro; Pietsch, Urs; Mair, Peter; Brugger, Hermann

2018-04-28

In this prospective, observational study we describe the incidence and characteristics of out of hospital cardiac arrest (OHCA) cases who received mechanical CPR, after the implementation of a mechanical CPR device (LUCAS 2; Physio Control, Redmond, WA, USA) in a physician staffed helicopter emergency medical service (HEMS) in South Tyrol, Italy. During the study period (06/2013-04/2016), 525 OHCA cases were registered by the dispatch centre, 271 (51.6%) were assisted by HEMS. LUCAS 2 was applied in 18 (6.6%) of all HEMS-assisted OHCA patients; ten were treated with LUCAS 2 at the scene only, and eight were transported to hospital with ongoing CPR. Two (11.1%) of the 18 patients survived long term with full neurologic recovery. In seven of eight patients transferred to hospital with ongoing CPR, CPR was ceased in the emergency room without further intervention. Retrospectively, all HEMS-assisted OHCA cases were screened for proposed indication criteria for prolonged CPR. Thirteen patients fulfilled these criteria, but only two of them were transported to hospital. Based on these results, we propose a standard operating procedure for HEMS-assisted patients with refractory OHCA in a region without hospitals with ECLS capacity.

A PROSPECTIVE OBSERVATIONAL STUDY OF SHORT TERM MORBIDITY PATTERN IN PRETERM NEWBORNS DELIVERED IN A TERTIARY CARE HOSPITAL

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Harsha

2015-08-01

Full Text Available OBJECTIVE: To study the short term morbidity pattern in preterm new born babies delivered in a tertiary care hospital with level III neonatal intensive care unit (NICU. MATERIAL AND METHODS: A prospective observational study was conducted in a level III NICU betwee n November 2009 to July 2010 at Grant medical college and JJ Group of hospitals, Mumbai. All the in born preterm babies were assessed for morbidity pattern from the time of admission till discharge or death. RESULT: 156 preterm babies were included in the study. 83(54.21% were male and 73(46.79% were female. The major morbidities observed in the preterm neonates were hyperbilirubinemia in 50.54%, Respiratory distress syndrome (RDS in25.64% and severe birth asphyxia in13.46%. Other common morbidities seen were retinopathy of prematurity in 12.17%, apnoea in 11.54% and anaemia in 10.9%. Preterm neonates also had in 9.62% culture proven sepsis, in 8.33% hypoglycaemia, in 7.05% Intraventricular haemorrhage (IVH and in 6.41% various congenital anomalies. CONCL USION: Hyperbilirubinemia, respiratory distress syndrome and severe birth asphyxia are major preterm morbidity

Improving the well-being of elderly patients via community pharmacy-based provision of pharmaceutical care - A multicentre study in seven European countries

NARCIS (Netherlands)

Bernsten, C; Bjorkman, [No Value; Caramona, M; Crealey, G; Frokjaer, B; Grundberger, E; Gustafsson, T; Henman, M; Herborg, H; Hughes, C; McElnay, J; Magner, M; van Mil, F; Schaeffer, M; Silva, S; Sondergaard, B; Sturgess, [No Value; Tromp, D; Vivero, L; Winterstein, A

2001-01-01

Objective: This study aimed to measure the outcomes of a harmonised, structured pharmaceutical care programme provided to elderly patients: (greater than or equal to 65 years of age) by community pharmacists in a multicentre international study performed in 7 European countries. Design and setting:

Predictors of stress among parents in pediatric intensive care unit: a prospective observational study.

Science.gov (United States)

Aamir, Mohd; Mittal, Kundan; Kaushik, Jaya Shankar; Kashyap, Haripal; Kaur, Gurpreet

2014-11-01

To determine the sociodemographic and clinical factors leading to stress among parents whose children are admitted in pediatric intensive care unit (PICU). A prospective observational study was conducted in PICU of a tertiary care hospital of north India. Parents of children admitted to PICU for at least 48 h duration were eligible for participation. At the end of 48 h, parental stress was assessed using parental stress scale (PSS:PICU) questionnaire which was administered to the parents. Baseline demographic and clinical parameters of children admitted to PICU were recorded. The parental stress was compared with demographic and clinical characteristics of children using appropriate statistical methods. A total of 49 parents were finally eligible for participation. Mean (SD) parental stress scores was highest in domains of procedures [1.52 (0.66)] and behavior and emotional [1.32 (0.42)] subscales. Mean (SD) total parental stress score among intubated children [1.31 (0.25)] was significantly more than among non intubated children [0.97 (0.26)] (p parental stress score were comparable in terms of gender (p = 0.15) and socioeconomic status (p = 0.32). On subscale analysis, it was found that professional communication is a significant stressor in age groups 0-12 mo [0.61(0.41)] (p = 0.02). It was observed that parents of intubated children were significantly stressed by the physical appearance of their children (p parental role (p = 0.002). Total parental stress score had a positive correlation with PRISM score (r = 0.308). Indian parents are stressed maximally with environment of PICU. Factor leading to parental stress was intubation status of the child and was not affected by gender or socio demographic profile of the parents.

Progress towards non-invasive diagnosis and follow-up of celiac disease in children : a prospective multicentre study to the usefulness of plasma I-FABP

NARCIS (Netherlands)

Adriaanse, Marlou P. M.; Mubarak, A; Riedl, R G; Ten Kate, F J W; Damoiseaux, J G M C; Buurman, Wim A.; Houwen, R H J; Vreugdenhil, A C E

2017-01-01

This prospective study investigates whether measurement of plasma intestinal-fatty acid binding protein (I-FABP), a sensitive marker for small intestinal epithelial damage, improves non-invasive diagnosing of celiac disease (CD), and whether I-FABP levels are useful to evaluate mucosal healing in

Prospective memory: effects of divided attention on spontaneous retrieval.

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Harrison, Tyler L; Mullet, Hillary G; Whiffen, Katie N; Ousterhout, Hunter; Einstein, Gilles O

2014-02-01

We examined the effects of divided attention on the spontaneous retrieval of a prospective memory intention. Participants performed an ongoing lexical decision task with an embedded prospective memory demand, and also performed a divided-attention task during some segments of lexical decision trials. In all experiments, monitoring was highly discouraged, and we observed no evidence that participants engaged monitoring processes. In Experiment 1, performing a moderately demanding divided-attention task (a digit detection task) did not affect prospective memory performance. In Experiment 2, performing a more challenging divided-attention task (random number generation) impaired prospective memory. Experiment 3 showed that this impairment was eliminated when the prospective memory cue was perceptually salient. Taken together, the results indicate that spontaneous retrieval is not automatic and that challenging divided-attention tasks interfere with spontaneous retrieval and not with the execution of a retrieved intention.

Using observational data to inform the design of a prospective effectiveness study for a novel insulin delivery device

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Grabner M

2013-09-01

Full Text Available Michael Grabner,1 Yong Chen,2 Matthew Nguyen,3 Scott D Abbott,3 Ralph Quimbo1 1HealthCore, Inc., Wilmington, DE, USA; 2Merck and Co., Inc., Whitehouse Station, NJ, USA; 3Valeritas, Inc., Bridgewater, NJ, USA Objective: To inform the design and assess the feasibility of a prospective effectiveness study evaluating an insulin delivery device for patients with diabetes mellitus to be conducted within the membership of a large US commercial insurer. Methods: Providers who issued ≥1 insulin prescription between January 1, 2011 and September 30, 2011 were selected from administrative claims contained in the HealthCore Integrated Research DatabaseSM. Adult diabetes patients with visits to these providers were identified. Providers were dichotomized into high- [HVPs] and low-volume providers [LVPs] based on median number of diabetes patients per provider. Results: We identified 15,349 HVPs and 15,313 LVPs (median number of patients = 14. Most HVPs were located in the Midwest (6,291 [41.0%] and South (5,092 [33.2%], while LVPs were evenly distributed across regions. Over 80% (12,769 of HVPs practiced family or internal medicine; 6.4% (989 were endocrinologists. HVPs prescribed insulin to an average of 25% of patients. Patients of HVPs (522,527 had similar characteristics as patients of LVPs (80,669, except for geographical dispersion, which followed that of providers. Approximately 65% of patients were aged 21-64 years and 97% had type 2 diabetes. Among patients with ≥1 available HbA1C result during 2011 (103,992, 48.3% (50,193 had an average HbA1C ≥7.0%. Among patients initiating insulin, 79.6% (22,205 had an average HbA1C ≥7.0%. Conclusion: The observed provider and patient populations support the feasibility of the prospective study. Sampling of patients from HVPs is efficient while minimizing bias as patient characteristics are similar to those from LVPs. The study also highlights unmet needs for improved glycemic control since approximately

Long-term effect of latanoprost/timolol fixed combination in patients with glaucoma or ocular hypertension: A prospective, observational, noninterventional study

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Schwenn Oliver

2010-09-01

Full Text Available Abstract Background Prospective, observational studies that enroll large numbers of patients with few exclusion criteria may better reflect actual ongoing clinical experience than randomized clinical trials. Our purpose was to obtain efficacy and safety information from a cohort of subjects exposed to latanoprost/timolol fixed combination (FC for ≥18 months using a prospective, observational design. Methods In all, 577 office-based ophthalmologists in Germany switched 2339 patients with glaucoma or ocular hypertension to latanoprost/timolol FC for medical reasons. Follow-up visits were scheduled for every 6 months over 24 months; physicians followed usual care routines. Intraocular pressure (IOP, visual field status, optic nerve head findings, and adverse events were recorded. Efficacy parameters were evaluated for the per protocol (PP population; the safety population included subjects receiving ≥1 drop of FC. Physicians rated efficacy, tolerability, and subject compliance at month 24. Results Of the 2339 subjects switched to latanoprost/timolol FC (safety population, the primary reasons for switching were inadequate IOP reduction (78.2% and desire to simplify treatment with once-daily dosing (29.4%; multiple reasons possible. In all, 1317 (56.3% subjects completed the study, and 1028 (44.0% were included in the PP population. Most discontinuations were due to loss to follow-up. Change in mean IOP from baseline to month 6 was -4.0 ± 4.31 mmHg, a reduction that was maintained throughout (P Conclusions Over 24 months, latanoprost/timolol FC effectively lowers IOP levels and is well tolerated in patients with glaucoma or ocular hypertension who change from their previous ocular hypotensive therapy for medical reasons. Investigator assessments found optic disc parameters and visual field to be stable throughout 24 months of follow-up.

Scenarios planning: the evolution of prospective thinking

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Maurício Fernandes Pereira

2005-01-01

Full Text Available The world is changing even more than before. Around the world, the organizational stability is in face of threats unnoticed before, due to technologic innovations, uncontrolled financial markets, up to date customers, and an observant society and government, in order to control the organizations’ social and environmental responsibilities. To face this threats, organizations needs to worry even more, renew its long range planning systems, and use Prospective Scenaries to find out, in a better way, the dynamic forces that will preveil in the next years. This paper seeks to clarify the source of prospective thinking that has created and developed this tool. Prospective Thinking is considered, nowadays, one of most innovatives tools used by the strategic management in organizations.

At-Risk Phenotype of Neurofibromatose-1 Patients: A Multicentre Case-Control Study

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Ferkal Salah

2011-07-01

Full Text Available Abstract Objectives To assess associations between subcutaneous neurofibromas (SC-NFs and internal neurofibromas in patients with neurofibromatosis type 1 (NF-1 and to determine whether the association between SC-NFs and peripheral neuropathy was ascribable to internal neurofibromas. Patients and methods Prospective multicentre case-control study. Between 2005 and 2008, 110 NF-1 adults having two or more SC-NFs were individually matched for age, sex and hospital with 110 controls who had no SC-NF. Patients underwent standardized MRI of the spinal cord, nerve roots and sciatic nerves and an electrophysiological study. Analyses used adjusted multinomial logistic regression (ORa to estimate the risk of the presence of internal neurofibromas or peripheral neuropathies associated with patients presented 2 to 9 SC-NFs, at least 10 SC-NFs as compared to patients without any (referential category. Results Cases had a mean age of 41 (± 13 years; 85 (80% had two to nine SC-NFs and 21 (19% at least ten SC-NFs. SC-NFs were more strongly associated with internal neurofibromas in patients with ten or more SC-NFs than in patients with fewer NF-SCs (e.g., sciatic nerve, aOR = 29.1 [8.5 to 100] vs. 4.3 [2.1 to 9.0]. The association with SC-NFs was stronger for diffuse, intradural, and > 3 cm internal neurofibromas than with other internal neurofibromas. Axonal neuropathy with slowed conduction velocities (SCV was more strongly associated with having at least ten SC-NFs (aOR = 29.9, 5.5 to 162.3 than with having fewer SC-NFs (aOR = 4.4, 0.9 to 22.0. Bivariate analyses showed that the association between axonal neuropathy with SCV and sciatic neurofibromas was mediated by the association between SC-NFs and sciatic neurofibromas. Conclusion The at-risk phenotype of NF-1 patients (i.e. NF-1 patients with SC-NFs is ascribable to associations linking SC-NFs to internal neurofibromas at risk for malignant transformation and to axonal neuropathies with slowed

THE PROSPECTIVE OBSERVATIONAL STUDY ON CUTANEOUS ADVERSE DRUG REACTIONS TO CHEMOTHERAPY

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Prakash Mani

2016-07-01

Full Text Available INTRODUCTION There are a wide spectrum of adverse cutaneous drug reactions (ACDRs varying from transient maculopapular rash to fatal toxic epidermal necrolysis (TEN. With the advent of newer and targeted therapy in the field of dermatology, the pattern of cutaneous adverse drug eruptions and the drugs responsible for them keep changing every year. Hence, this study was undertaken to ascertain the clinical spectrum of ACDRs and the causative drugs, in a tertiary care centre in South India. MATERIALS AND METHODS This study was a prospective, observational study conducted in Department of Medical Oncology, Government Rajaji Hospital, Madurai Medical College, Madurai during the period of March 2015 - August 2015 (6 months. Severity of the reaction was assessed using CTCAE (Common Terminology Criteria for Adverse Events scale version 4.1. Causality of the drug was assessed using Naranjo Causality Assessment Scale. The scale was calculated first for the regimen and then for individual drugs separately. The adverse events with score of 6 or more (probable and definite adverse events were taken for the study. RESULTS AND CONCLUSION The overall incidence of ACDRs found in this study was 85%. Alopecia was the commonest ACDR occurring in 51.6% of patients. Nail pigmentation and supravenous pigmentation were the next common ACDRs, recorded in 35% and 16% of patients respectively. Imatinib caused generalised hypopigmentation in 40% of patients. Bleomycin induced, flagellate erythema and pigmentation in 17% of patients and stomatitis was seen in 11% of patients. Acneiform eruptions were recorded with erlotinib and gefitinib therapy. Supravenous pigmentation was common with 5-fluorouracil and docetaxel, occurring in 53% & 48% respectively. Newer targeted therapies like EGFR (Epidermal growth factor receptor inhibitors recorded low incidence of ACDRs like alopecia as against conventional antineoplastic agents. The cancer chemotherapeutic drugs are associated

Clinical and echographic characteristics of patients exposed to fenfluramin or its derivatives: Results of a prospective, single-centre, observational study.

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Cambon, David; Leclercq, Florence

2015-03-01

Fenfluramine and its derivatives have been associated with significant risk of developing valvular heart disease but its exact prevalence and severity are still debated. To evaluate the clinical and echocardiographic characteristics of patients hospitalized in a cardiology centre and who had past exposure to these drugs. Between July 2011 and February 2012, patients admitted to the hospitalization and intensive care units at the University Centre of Montpellier, France were questioned about past exposure to fenfluramine or its derivatives. In patients who reported exposure, a questionnaire assessing prescribing patterns and medical history was proposed and echocardiography performed. All of the usual echocardiographic variables were analysed. We applied criteria from a French multicentre registry for diagnosis of drug-induced valvulopathy: leaflets and subvalvular apparatus thickening and retraction, leaflets loss of coaptation, no calcification, and no stenosis. Ninety-five patients exposed to these drugs were included. The majority were female (n=62, 65.3%), 53.2% (n=50) had diabetes and 90.5% (n=86) were exposed to benfluorex. Mean treatment duration was 52.3months (95% confidence interval [CI] 39.0-65.6). Valvular regurgitations were observed in 64.0% of patients (n=57) while 19.8% (n=17) had pulmonary hypertension. Highly probable fenfluramine-induced regurgitations were present in 18.6% (n=16) of patients, possibly fenfluramine-induced regurgitations in 38.2% (n=34) of patients, and unlikely fenfluramine-induced regurgitations in 25.8% (n=23) of patients. Highly probable fenfluramine-induced regurgitations were mild to moderate in severity in all except three patients. Considering the frequency of probable or possible fenfluramine-induced regurgitations and in the absence of definite knowledge about the evolution of drug-induced valvular disease, systematic questioning about fenfluramine use may be advisable in hospitalized cardiac patients. Copyright © 2015

Evaluation of fixed dose combination of glimepiride and metformin in patients with type 2 diabetes. Results of Russian observational study

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Natalya Vladislavovna Zaytseva

2015-04-01

Full Text Available Aim. To investigate the efficacy and safety of combined glimepiride and metformin therapy in patients with type 2 diabetes mellitus (T2DM. Materials and methods. A multi-centre, open-label, prospective, observational study was conducted. A total of 1200 patients with T2DM inadequately controlled with metformin, glimepiride or combination of metformin + glimepiride were enrolled. Change in serum glycated haemoglobin (HbA1c, fasting plasma glucose (FPG, and postprandial blood glucose (PPG levels; weight; waist circumference and hypoglycemic episodes were evaluated. Results. Baseline HbA1c levels (8.24% ? 0.42% were significantly reduced after 12 weeks of treatment (7.48% ? 0.48% and at the end of the study. (6.88% ? 0.56%. Target HbA1c levels (?7% were achieved in 65.1% of patients at the final visit at 24 weeks. FPG and PPG levels decreased by 1.45 ? 1.14 mmol/l and 2.17 ? 1.27 mmol/l respectively (p < 0.001. No severe hypoglycemic events were reported. Body mass index reduced by 0.85 ? 1.28 kg/m2 (p < 0.001. Conclusion. . Combined glimepiride and metformin therapy significantly improved long-term glycemic control in patients with T2DM during the period of 24 weeks. without additional risk of hypoglycemic events or weight gain.

Evaluation of fixed dose combination of glimepiride and metformin in patients with type 2 diabetes. Results of Russian observational study

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Natalya Vladislavovna Zaytseva

2015-04-01

Full Text Available Aim.To investigate the efficacy and safety of combined glimepiride and metformin therapy in patients with type 2 diabetes mellitus (T2DM.Materials and methods.A multi-centre, open-label, prospective, observational study was conducted. A total of 1200 patients with T2DM inadequately controlled with metformin, glimepiride or combination of metformin + glimepiride were enrolled. Change in serum glycated haemoglobin (HbA1c, fasting plasma glucose (FPG, and postprandial blood glucose (PPG levels; weight; waist circumference and hypoglycemic episodes were evaluated.Results.Baseline HbA1c levels (8.24% ± 0.42% were significantly reduced after 12 weeks of treatment (7.48% ± 0.48% and at the end of the study(6.88% ± 0.56%. Target HbA1c levels (≤7% were achieved in 65.1% of patients at the final visit at 24 weeks. FPG and PPG levels decreased by 1.45 ± 1.14 mmol/l and 2.17 ± 1.27 mmol/l respectively (p < 0.001. No severe hypoglycemic events were reported. Body mass index reduced by 0.85 ± 1.28 kg/m2 (p < 0.001.Conclusion. Combined glimepiride and metformin therapy significantly improved long-term glycemic control in patients with T2DM during the period of 24 weeks without additional risk of hypoglycemic events or weight gain.

Baseline characteristics in PRIORITY study: Proteomics and mineralocorticoid receptor antagonism for prevention of diabetic nephropathy in type 2 diabetes

DEFF Research Database (Denmark)

Tofte, Nete

diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria) trial, the aim is to confirm that CKD273 can predict microalbuminuria prospectively, and to test whether mineralocorticoid receptor antagonism (MRA) delays progression to microalbuminuria. Here we report the association between CKD273...... and traditional risk factors for diabetic nephropathy at baseline. Materials and methods PRIORITY is an investigator-initiated, prospective, randomized, double blind, placebo-controlled multicentre clinical trial and observational study in normoalbuminuric type 2 diabetic patients. Patients are stratified...... is development of microalbuminuria. Results In total 2277 type 2 diabetic patients have been screened over a time period of 2.5 years and 1811 are included from 15 sites. Table 1 shows the baseline characteristics. 224 (12.4%) have the high-risk CKD273 pattern. The high- and low-risk populations differ...

Postural and Balance Disorders in Patients with Parkinson's Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

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Santamato, Andrea; Ranieri, Maurizio; Cinone, Nicoletta; Stuppiello, Lucia Anna; Valeno, Giovanni; De Sanctis, Jula Laura; Fortunato, Francesca; Solfrizzi, Vincenzo; Greco, Antonio; Seripa, Davide; Panza, Francesco

2015-01-01

Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson's disease (PD) to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy) for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients. PMID:26798551

A prospective, multicenter, observational study of complicated skin and soft tissue infections in hospitalized patients: clinical characteristics, medical treatment, and outcomes

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Lipsky Benjamin A

2012-09-01

Full Text Available Abstract Background Complicated skin and soft tissue infections (cSSTIs occur frequently, but limited data do not allow any consensus on an optimal treatment strategy. We designed this prospective, multicenter, observational study to to explore the current epidemiology, treatment, and resulting clinical outcomes of cSSTIs to help develop strategies to potentially improve outcomes. Methods From June 2008 to December 2009 we enrolled a pre-specified number of adults treated in 56 U.S. hospitals with intravenous antibiotic(s for any of the following cSSTIs: diabetic foot infection (DFI; surgical site infection (SSI; deep soft tissue abscess (DSTA; or, cellulitis. Investigators treated all patients per their usual practice during the study and collected data on a standardized form. Results We enrolled 1,033 patients (DFI 27%; SSI 32%; DSTA 14%; cellulitis 27%; mean age 54 years; 54% male, of which 74% had healthcare-associated risk factors. At presentation, 89% of patients received initial empiric therapy with intravenous antibiotics; ~20% of these patients had this empiric regimen changed or discontinued based on culture and sensitivity results. Vancomycin was the most frequently used initial intravenous antibiotic, ordered in 61% of cases. During their stay 44% of patients underwent a surgical procedure related to the study infection, usually incision and drainage or debridement. The mean length of stay was 7.1 days, ranging from 5.8 (DSTA to 8.1 (SSI. Conclusion Our findings from this large prospective observational study that characterized patients with cSSTIs from diverse US inpatient populations provide useful information on the current epidemiology, clinical management practices and outcomes of this common infection.

Patients with alcohol use disorder: initial results from a prospective multicenter registry in the Spanish Network on Addiction Disorders. CohRTA Study.

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Sanvisens, Arantza; Zuluaga, Paola; Rivas, Inmaculada; Rubio, Gabriel; Gual, Antoni; Torrens, Marta; Short, Antoni; Álvarez, Francisco Javier; Tor, Jordi; Farré, Magí; Rodríguez de Fonseca, Fernando; Muga, Roberto

2017-07-14

The Alcohol Program of the Spanish Network on Addictive Disorders-RTA requires a longitudinal study to address different research questions related to alcoholism. The cohort study (CohRTA) focuses on patients seeking treatment for alcohol use disorder, as a multicentre, collaborative research project aimed to improve secondary prevention and early diagnosis of pathological processes associated with the disorder. multicentre cohort study in adults (>18 years) seeking their first treatment of the disorder. Patients sign an informed consent and data is collected in an online platform specifically designed for the study; patients are also requested to provide biological samples that are stored in a biobank. Baseline and prospective, socio-demographic, epidemiological, clinical and treatment data are collected. Currently there are 10 participating centres that expect to recruit more than 1,000 patients. As of December 2015, 344 patients (77% men) were included. Median age at admission was 50 years (IQR: 43-55 years). Median age at the start of alcohol consumption was 15 years (IQR: 14-18 years) and 61% of cases reported antecedents of alcohol use disorder in the family. During the 30 days prior to admission, alcohol consumption amounted to 12.5 SDU/day (IQR: 7.1-20 SDU/day), 72% of the patients were tobacco smokers and 30% currently used cocaine. Organising an open cohort of patients with alcohol use disorder may be crucial to better understand the clinical consequences of alcoholism in Spain. This cohort may potentiate quantitative and qualitative research within the Spanish Network on Addictive Disorders-RTA/RETICS. Having a well-established, representative cohort of patients will increase translational research on consequences of alcoholism in our country.

Tissue-Based MRI Intensity Standardization: Application to Multicentric Datasets

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Nicolas Robitaille

2012-01-01

Full Text Available Intensity standardization in MRI aims at correcting scanner-dependent intensity variations. Existing simple and robust techniques aim at matching the input image histogram onto a standard, while we think that standardization should aim at matching spatially corresponding tissue intensities. In this study, we present a novel automatic technique, called STI for STandardization of Intensities, which not only shares the simplicity and robustness of histogram-matching techniques, but also incorporates tissue spatial intensity information. STI uses joint intensity histograms to determine intensity correspondence in each tissue between the input and standard images. We compared STI to an existing histogram-matching technique on two multicentric datasets, Pilot E-ADNI and ADNI, by measuring the intensity error with respect to the standard image after performing nonlinear registration. The Pilot E-ADNI dataset consisted in 3 subjects each scanned in 7 different sites. The ADNI dataset consisted in 795 subjects scanned in more than 50 different sites. STI was superior to the histogram-matching technique, showing significantly better intensity matching for the brain white matter with respect to the standard image.

Prospective, Controlled, Multicentre Study of Loperimide in Pregnancy

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A Einarson

2000-01-01

Full Text Available BACKGROUND: Loperamide is a synthetic piperidine derivative used for the treatment of both acute and chronic diarrhea. Little is known about its safety and risk in pregnancy. Human data are limited to one surveillance study of Michigan Medicaid patients, with 108 women exposed in the first trimester. In this study there were six major birth defects, three of which were cardiovascular anomalies.

Early multicentre experience of pre-pectoral implant based immediate breast reconstruction using Braxon®.

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Jafferbhoy, Sadaf; Chandarana, Mihir; Houlihan, Maria; Parmeshwar, Rishikesh; Narayanan, Sankaran; Soumian, Soni; Harries, Simon; Jones, Lucie; Clarke, Dayalan

2017-12-01

The last two decades have seen significant changes in surgical management of breast cancer. The offer of immediate breast reconstruction (IBR) following mastectomy is currently standard practice. Skin sparing and nipple sparing mastectomy with implant-based IBR have emerged as oncologically safe treatment options. Prepectoral implant placement and complete coverage of implant with acellular dermal matrix (ADM) eliminates the need to detach the muscle from underlying chest wall in contrast to the subpectoral technique. We report short-term outcomes of a multicentre study from the United Kingdom (UK) using Braxon ® in women having an IBR. A prospective study was conducted from December 2015 to October 2016 and included all patients from three breast units in the UK who underwent a mastectomy and an implant-based IBR using Braxon ® . The demographic details, co-morbidities, operative details, immediate and delayed complications were recorded. Specific complications recorded were infection, seroma, unplanned readmission and loss of implant. A comparison was made with complications reported in the National Mastectomy and Reconstruction Audit. Seventy-eight IBRs were included in the analysis with a median follow-up of 9.98 months. Mean age of the cohort was 50 years with a mean body mass index of 25.7 kg/m 2 . Mean implant volume was 365 cc. The inpatient hospital stay was 1.48 days. About 23% of patients had a seroma, 30% had erythema requiring antibiotics and the explant rate was 10.2 percent. Bilateral reconstructions were significantly associated with implant loss and peri-operative complications on univariate analysis. Our early experience with this novel prepectoral technique using Braxon ® has shown it to be an effective technique with complication rates comparable to subpectoral IBR. The advantages of prepectoral implant-based IBR are quicker postoperative recovery and short post-operative hospital stay. Long-term studies are required to assess rippling, post

Patient-centered and clinical outcomes of mandibular overdentures retained with the locator system: A prospective observational study.

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Fernandez-Estevan, Lucia; Montero, Javier; Selva Otaolaurruchi, Eduardo J; Sola Ruiz, Fernanda

2017-03-01

Whether clinical or demographic variables affect the perception of treatment in terms of quality of life and satisfaction is unknown. The purpose of this prospective study was to make an evidence-based assessment of the treatment outcomes (patient- and clinically based) of locator-retained mandibular overdentures. This prospective observational study assessed patients with edentulism who had worn mandibular overdentures supported by 2 implants and retained by the locator system for at least 1 year of functional life (N=80). Medical histories were reviewed, and patients underwent oral examinations. Prosthetic clinical outcomes and patient well-being were registered using the Oral Health Impact Profile 20 (OHIP-20) and Oral Satisfaction Scale (OSS). Patient well-being scored an overall OHIP-20 score of 19.0 ±14.0 of 80 (the higher the score, the greater the impact and the worse the oral health-related quality of life); overall oral satisfaction was 8.3 ±1.7 of 10. Women suffered greater social impact (0.8 ±1.0) and disability (0.4 ±0.8) than men (0.4 ±0.7 versus 0.2 ±0.4, respectively). Impact on well-being was inversely proportional to both patient age and the age of the prosthesis (r=-0.25; Poverdentures had been functioning for over 60 months. Relining (46.3%), readjustments (82.5%), and changes of nylon retention (1.5 ±1.8 per patient over 60 months of use) devices negatively influenced well-being. Mandibular overdentures produced good results with regard to quality of life and oral satisfaction, but attention should be paid to factors affecting clinical outcomes and patient well-being. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Incidence and risk factors for delirium development in ICU patients - a prospective observational study.

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Kanova, Marcela; Sklienka, Peter; Roman, Kula; Burda, Michal; Janoutova, Jana

2017-06-01

Delirium is an acute brain dysfunction and a frequent complication in critically ill patients. When present it significantly worsens the prognosis of patients. The aim of this study was to evaluate the incidence of delirium and risk factors for delirium in a mixed group of trauma, medical and surgical ICU patients. A prospective observational study was conducted in one of the six-bed Intensive Care Units of the University Hospital Ostrava in the Czech Republic during a 12-month period. We evaluated the incidence of delirium and its predisposing and precipitating risk factors. All patients were assessed daily using the Confusion Assessment Method for the ICU (CAM-ICU). Of the total of 332 patients with a median APACHE II (the Acute Physiology and Chronic Health Evaluation) score of 12, who were evaluated for delirium, 48 could not be assessed using CAM-ICU (47 due to prolonged coma, 1 due to language barriers). The incidence of delirium was 26.1%, with trauma and medical patients being more likely to develop delirium than surgical patients. Risk of delirium was significantly associated with age ≥ 65 years, and alcohol abuse in their anamnesis, with APACHE II score on admission, and with the use of sedatives and/or vasopressors. Delirious patients who remained in the ICU for a prolonged period showed a greater need for ventilator support and had a greater ICU-mortality.

Comparison of outcomes between emergent-start and planned-start peritoneal dialysis in incident ESRD patients: a prospective observational study.

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Li, Wen-Yi; Wang, Yi-Cheng; Hwang, Shang-Jyh; Lin, Shih-Hua; Wu, Kwan-Dun; Chen, Yung-Ming

2017-12-11

The clinical consequences of starting chronic peritoneal dialysis (PD) after emergent dialysis via a temporary hemodialysis (HD) catheter has rarely been evaluated within a full spectrum of treated end-stage renal disease (ESRD). We investigated the longer-term outcomes of patients undergoing emergent-start PD in comparison with that of other practices of PD or HD in a prospective cohort of new-onset ESRD. This was a 2-year prospective observational study. We enrolled 507 incident ESRD patients, among them 111 chose PD (43 planned-start, 68 emergent-start) and 396 chose HD (116 planned-start, 280 emergent-start) as the long-term dialysis modality. The logistic regression model was used to identify variables associated with emergent-start dialysis. The Kaplan-Meier survival analysis was used to determine patient survival and technique failure. The propensity score-adjusted Cox regression model was used to identify factors associated with patient outcomes. During the 2-year follow-up, we observed 5 (4.5%) deaths, 15 (13.5%) death-censored technique failures (transfer to HD) and 3 (2.7%) renal transplantations occurring in the PD population. Lack of predialysis education, lower predialysis estimated glomerular filtration rate and serum albumin were predictors of being assigned to emergent dialysis initiation. The emergent starters of PD displayed similar risks of patient survival, technique failure and overall hospitalization, compared with the planned-start counterparts. By contrast, the concurrent planned-start and emergent-start HD patients with an arteriovenous fistula or graft were protected from early overall death and access infection-related mortality, compared with the emergent HD starters using a central venous catheter. In late-referred chronic kidney disease patients who have initiated emergent dialysis via a temporary HD catheter, post-initiation PD can be a safe and effective long-term treatment option. Nevertheless, due to the potential complications

Early assisted discharge with generic community nursing for chronic obstructive pulmonary disease exacerbations: Results of a randomised controlled trial

NARCIS (Netherlands)

C.M.A. Utens (Cecile); L.M.A. Goossens (Lucas); F.W.J.M. Smeenk (Frank); M.P.M.H. Rutten-van Mölken (Maureen); M. van Vliet (Monique); M.W. Braken (Maria); L. van Eijsden (Loes); O.C.P. Schayck (Onno)

2012-01-01

textabstractObjectives: To determine the effectiveness of early assisted discharge for chronic obstructive pulmonary disease (COPD) exacerbations, with home care provided by generic community nurses, compared with usual hospital care. Design: Prospective, randomised controlled and multicentre trial

Tolerability of the capsaicin 8% patch following pretreatment with lidocaine or tramadol in patients with peripheral neuropathic pain: A multicentre, randomized, assessor-blinded study

NARCIS (Netherlands)

Jensen, T.S.; Hoye, K.; Fricova, J.; Vanelderen, P.J.L.; Ernault, E.; Siciliano, T.; Marques, S.

2014-01-01

BACKGROUND: Application of the capsaicin 8% patch is associated with treatment-related discomfort. Consequently, pretreatment for 60 min with anaesthetic cream is recommended; however, this may be uncomfortable and time consuming. METHODS: We conducted a multicentre, randomized (1:1),

Sensitivity of imaging for multifocal-multicentric breast carcinoma

Directory of Open Access Journals (Sweden)

Viale Giuseppe

2008-09-01

Full Text Available Abstract Background This retrospective study aims to determine: 1 the sensitivity of preoperative mammography (Mx and ultrasound (US, and re-reviewed Mx to detect multifocal multicentric breast carcinoma (MMBC, defined by pathology on surgical specimens, and 2 to analyze the characteristics of both detected and undetected foci on Mx and US. Methods Three experienced breast radiologists re-reviewed, independently, digital mammography of 97 women with MMBC pathologically diagnosed on surgical specimens. The radiologists were informed of all neoplastic foci, and blinded to the original mammograms and US reports. With regards to Mx, they considered the breast density, number of foci, the Mx characteristics of the lesions and their BI-RADS classification. For US, they considered size of the lesions, BI-RADS classification and US pattern and lesion characteristics. According to the histological size, the lesions were classified as: index cancer, 2nd lesion, 3rd lesion, and 4th lesion. Any pathologically identified malignant foci not previously described in the original imaging reports, were defined as undetected or missed lesions. Sensitivity was calculated for Mx, US and re-reviewed Mx for detecting the presence of the index cancer as well as additional satellite lesions. Results Pathological examination revealed 13 multifocal and 84 multicentric cancers with a total of 303 malignant foci (282 invasive and 21 non invasive. Original Mx and US reports had an overall sensitivity of 45.5% and 52.9%, respectively. Mx detected 83/97 index cancers with a sensitivity of 85.6%. The number of lesions undetected by original Mx was 165/303. The Mx pattern of breasts with undetected lesions were: fatty in 3 (1.8%; scattered fibroglandular density in 40 (24.3%, heterogeneously dense in 91 (55.1% and dense in 31 (18.8% cases. In breasts with an almost entirely fatty pattern, Mx sensitivity was 100%, while in fibroglandular or dense pattern it was reduced to 45

The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

DEFF Research Database (Denmark)

Gerhardsen, G.; Hansen, A.V.; Killi, M.

2008-01-01

Introduction: A double-blind, placebo-controlled, randomised, parallel-group, multicentre study was conducted to evaluate the effect of a pollen-based herbal medicinal product, Femal (R) (Sea-Band Ltd, Leicestershire, UK), on premenstrual sleep disturbances (PSD) in women with premenstrual syndrome...... as the main symptom cluster makes this herbal medicinal product a promising addition to the therapeutic arsenal for women with PMS Udgivelsesdato: 2008/6...

Auditive stimulation therapy as an intervention in subacute and chronic tinnitus: a prospective observational study.

Science.gov (United States)

Kusatz, Martin; Ostermann, Thomas; Aldridge, David

2005-01-01

Tinnitus is a noise, a ringing, or a roaring sound in the affected ear and is becoming an increasingly serious problem for health care systems. Integrative treatment concepts are currently regarded as promising therapeutic approaches for managing tinnitus. The aim of this study was to present the results of auditive stimulation therapy, a program of music therapy developed specifically for tinnitus treatment. We collected data on outpatient treatment results from 155 tinnitus patients and evaluated them in a prospective observational study with three defined times of measurement (start, end, and 6 months after the end of treatment). Apart from anamnestic data and subjective evaluation of treatment, the major outcome parameter was the score of the tinnitus questionnaire. To evaluate effectiveness of the therapy, we calculated effect sizes (according to Cohen). Fifty-one percent of the patients were male, and the mean patient age was 49 years. Of the 155 patients, 137 (88%) were capable of gainful employment, which means that they fell in the age range between 18 and 65 years. The duration of tinnitus was more than 6 months for 80% of patients, and 43% had been suffering from tinnitus for more than 3 years. In general, all subscales of the tinnitus questionnaire showed highly significant changes (t-test, p observe a reduction to the level prior to treatment. The values for the effect sizes mostly ranged between medium (> 0.5) and high (> 0.8). Closer investigations indicated that a combination of music therapy and psychological training rendered the best effect sizes. This study demonstrated that music therapy is an effective integrated treatment approach and offers a way to make progress in tinnitus treatment.

Comparative activity of tigecycline and tetracycline on Gram-negative and Gram-positive bacteria revealed by a multicentre study in four North European countries

DEFF Research Database (Denmark)

Nilsson, Lennart E; Frimodt-Møller, Niels; Vaara, Martti

2011-01-01

This study involves a multicentre surveillance of tigecycline and tetracycline activity against Gram-negative and Gram-positive bacteria from primary care centres (PCCs), general hospital wards (GHWs) and intensive care units (ICUs) in Denmark (n = 9), Finland (n = 10), Norway (n = 7) and Sweden (n...

Exploring venlafaxine pharmacokinetic variability with a phenotyping approach, a multicentric french-swiss study (MARVEL study).

Science.gov (United States)

Lloret-Linares, Célia; Daali, Youssef; Chevret, Sylvie; Nieto, Isabelle; Molière, Fanny; Courtet, Philippe; Galtier, Florence; Richieri, Raphaëlle-Marie; Morange, Sophie; Llorca, Pierre-Michel; El-Hage, Wissam; Desmidt, Thomas; Haesebaert, Frédéric; Vignaud, Philippe; Holtzmann, Jerôme; Cracowski, Jean-Luc; Leboyer, Marion; Yrondi, Antoine; Calvas, Fabienne; Yon, Liova; Le Corvoisier, Philippe; Doumy, Olivier; Heron, Kyle; Montange, Damien; Davani, Siamak; Déglon, Julien; Besson, Marie; Desmeules, Jules; Haffen, Emmanuel; Bellivier, Frank

2017-11-07

It is well known that the standard doses of a given drug may not have equivalent effects in all patients. To date, the management of depression remains mainly empirical and often poorly evaluated. The development of a personalized medicine in psychiatry may reduce treatment failure, intolerance or resistance, and hence the burden and costs of mood depressive disorders. The Geneva Cocktail Phenotypic approach presents several advantages including the "in vivo" measure of different cytochromes and transporter P-gp activities, their simultaneous determination in a single test, avoiding the influence of variability over time on phenotyping results, the administration of low dose substrates, a limited sampling strategy with an analytical method developed on DBS analysis. The goal of this project is to explore the relationship between the activity of drug-metabolizing enzymes (DME), assessed by a phenotypic approach, and the concentrations of Venlafaxine (VLX) + O-demethyl-venlafaxine (ODV), the efficacy and tolerance of VLX. This study is a multicentre prospective non-randomized open trial. Eligible patients present a major depressive episode, MADRS over or equal to 20, treatment with VLX regardless of the dose during at least 4 weeks. The Phenotype Visit includes VLX and ODV concentration measurement. Following the oral absorption of low doses of omeprazole, midazolam, dextromethorphan, and fexofenadine, drug metabolizing enzymes activity is assessed by specific metabolite/probe concentration ratios from a sample taken 2 h after cocktail administration for CYP2C19, CYP3A4, CYP2D6; and by the determination of the limited area under the curve from the capillary blood samples taken 2-3 and 6 h after cocktail administration for CYP2C19 and P-gp. Two follow-up visits will take place between 25 and 40 days and 50-70 days after inclusion. They include assessment of efficacy, tolerance and observance. Eleven french centres are involved in recruitment, expected to be

Prospective construction and validation of a prognostic score to identify patients who benefit from third-line chemotherapy for metastatic breast cancer in terms of overall survival: the METAL3 Study.

Science.gov (United States)

Filleron, Thomas; Bonnetain, Franck; Mancini, Julien; Martinez, Alejandra; Roché, Henri; Dalenc, Florence

2015-01-01

Metastatic breast cancer (MBC) is an incurable disease and represents a complex therapeutic challenge for oncologists. Despite the possibility of prescribing new agents such as tailored therapy, cytotoxic chemotherapy and hormone therapy remain the major treatments for MBC. Several lines of chemotherapy can be proposed for these patients, but beyond the second-line, evidence of effectiveness is lacking and such treatment has important associated toxicity affecting quality of life (QoL). Prospective data on third-line chemotherapy is very poor. There is no recent retrospective data and it mainly includes single-centre experiences. Moreover, prognostic parameters considered in these retrospective studies are limited to clinico-pathological factors. Previous reports don't evaluate prognostic impact of circulating tumour cells (CTC) and baseline QoL. METAL3 METAstatic Line 3 is a prospective, multicentric trial designed to prospectively construct a prognostic score (including selected clinico-pathological factors, CTC and baseline QoL) to identify patients who benefit from third-line chemotherapy for MBC in terms of overall survival (training cohort). Score will then be validated with another cohort (validation cohort). The aim of this paper is to review literature data on third-line chemotherapy for MBC and to describe in detail our prospective study. We hope that this prognostic score could be used by physicians to develop new therapeutic strategies when there will be limited benefit of third-line chemotherapy; this score will also help to improve patient information on their outcome. Copyright © 2014 Elsevier Inc. All rights reserved.

Early experience with transfemoral endovascular aneurysm management (TEAM) in the treatment of aortic aneurysms

NARCIS (Netherlands)

Balm, R.; Eikelboom, B. C.; May, J.; Bell, P. R.; Swedenborg, J.; Collin, J.

1996-01-01

OBJECTIVES: To evaluate the early experience with transfemoral endovascular aortic aneurysm management using the Endovascular Grafting System. DESIGN: Multi-centre prospective evaluation of the implantation procedure and early results (median follow-up 153 days). SETTING: Department of Surgery,

Critical care admission of South African (SA) surgical patients ...

African Journals Online (AJOL)

Methods. The SA Surgical Outcomes Study (SASOS) was a 7-day national, multicentre, prospective, ...... L R Math ivha, T R Mokoena, S Monokoane, R Moreno, D F Morrell, ... stone Hospital: L Friedman, D Schmidt*, S Venter; Nelson Mandela.

Exploration of Uranium in Simpang Kanan, East Aceh, Preliminary Prospecting Stages

International Nuclear Information System (INIS)

Djalil, A; Sutriyono, A; Sajiyo

1998-01-01

Exploration of uranium in simpang kanan, east aceh, preliminary prospecting stages. The research has been carried out to obtain the knowledge of geology, radiometry and geochemistry in relation with U prospect development. Based on the similarity of lithology in takengon sector which indicates the existence of uranium mineralization. Research method consist of geological observation, radiometric measurements of outcrops, boulders and stream sediment and heavy mineral samples. Laboratory analysis consist of petrography, autoradiography and uranium content analysis of stream sediment and rock samples. The lithology consist of slate, quartzite, marble, granite, dacite, limestone, carbonaceous sandstone, black claystone, sandstone, siltstone, carbonaceous siltstone. This area found, has been folded with the folding axis direction of NW-SE. Fault structures are generally formed as strike slip fault and several location as normal fault and heavy minerals anomalous was interpreted from granite and sandstone- siltstone. Occurrences of the geochemical anomaly, lithology and geological structures, there has been shown that few location is being the prospect area covered about 70 km of 1800km prospecting area, so it is suggested that in those related prospect area should be performed further observation

Non conventional psychiatric rehabilitation in schizophrenia using therapeutic riding: the FISE multicentre Pindar project

Directory of Open Access Journals (Sweden)

Stefania Cerino

2011-12-01

Full Text Available The FISE (Federazione Italiana Sport Equestri Pindar is a multicentre research project aimed at testing the potential effects of therapeutic riding on schizophrenic patients. Twenty-four subjects with a diagnosis of schizophrenia were enrolled for a 1 year-treatment involving therapeutic riding sessions. All subjects were tested at the beginning and at the end of treatment with a series of validated test batteries (BPRS and 8 items-PANSS. The results discussed in this paper point out an improvement in negative symptoms, a constant disease remission in both early onset and chronic disease subjects, as well as a reduced rate of hospitalization.

Do depression and anxiety reduce the likelihood of remission in rheumatoid arthritis and psoriatic arthritis? Data from the prospective multicentre NOR-DMARD study.

Science.gov (United States)

Michelsen, Brigitte; Kristianslund, Eirik Klami; Sexton, Joseph; Hammer, Hilde Berner; Fagerli, Karen Minde; Lie, Elisabeth; Wierød, Ada; Kalstad, Synøve; Rødevand, Erik; Krøll, Frode; Haugeberg, Glenn; Kvien, Tore K

2017-11-01

To investigate the predictive value of baseline depression/anxiety on the likelihood of achieving joint remission in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) as well as the associations between baseline depression/anxiety and the components of the remission criteria at follow-up. We included 1326 patients with RA and 728 patients with PsA from the prospective observational NOR-DMARD study starting first-time tumour necrosis factor inhibitors or methotrexate. The predictive value of depression/anxiety on remission was explored in prespecified logistic regression models and the associations between baseline depression/anxiety and the components of the remission criteria in prespecified multiple linear regression models. Baseline depression/anxiety according to EuroQoL-5D-3L, Short Form-36 (SF-36) Mental Health subscale ≤56 and SF-36 Mental Component Summary ≤38 negatively predicted 28-joint Disease Activity Score anxiety was associated with increased patient's and evaluator's global assessment, tender joint count and joint pain in RA at follow-up, but not with swollen joint count and acute phase reactants. Depression and anxiety may reduce likelihood of joint remission based on composite scores in RA and PsA and should be taken into account in individual patients when making a shared decision on a treatment target. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A comparison of tumour size measurements with palpation, ultrasound and mammography in male breast cancer: first results of the prospective register study.

Science.gov (United States)

Streng, Martin; Ignatov, Atanas; Reinisch, Mattea; Costa, Serban-Dan; Eggemann, Holm

2018-02-01

Precise presurgical diagnosis of tumour size is essential for adequate treatment of male breast cancer (MBC). This study is aimed to compare the accuracy of clinical measurement (CE), ultrasound (US) and mammography (MG) for preoperative estimation of tumour size. This study was conducted as a prospective, multicentre register study. One hundred and twenty-nine male patients with invasive breast cancer were included. CE, US and MG were performed in 107, 110 and 75 patients, respectively, and the estimated tumour size was compared with the histopathological (HP) tumour size. All methods tended to underestimate the HP tumour size. None of the methods were significantly more accurate than the others in determining the maximal tumour diameter. The sensitivity within 5 mm tolerance for US was 65.5%, which was better than for MG (61.3%) and CE (56.6%). In the group of patients with pT2 tumours, MG showed significantly better accuracy than US. The measurements obtained with each method were significantly correlated with the HP measurements. The highest correlation coefficient was observed for MG (0.788), followed by US (0.741) and CE (0.671). Our data demonstrate that MG and US have similar accuracy with regard to tumour size estimation. US assessment showed the highest sensitivity in determining tumour size, followed by MG and CE. However, MG demonstrated a significant advantage for estimating the real tumour size for pT2 tumours compared to US or CE.

Italian multicentre study on intrathecal fluorescein for craniosinusal fistulae.

Science.gov (United States)

Felisati, G; Bianchi, A; Lozza, P; Portaleone, S

2008-08-01

derives from frequent reports of complications, often related to the intrathecal administration; such complications are, however, always due to an incorrect dosage. In order to perform correct monitoring of any complication related to the use of intrathecal fluorescein and to investigate in a strictly scientific fashion, the legal problem related to the off label use (intrathecal administration) of an authorised substance, the Authors coordinated an Italian multicentre study aimed at establishig the tolerability of the lumbar intrathecal administration of fluorescein. Aim of the study was to review the literature focusing on CSF leaks, to set up to date diagnostic and therapeutic indications of fluorescein and to report the preliminary results of the Italian multicentre study.

The European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC: experiences from a successful ERS Clinical Research Collaboration

Directory of Open Access Journals (Sweden)

James D. Chalmers

2017-09-01

To understand the role of Clinical Research Collaborations as the major way in which the European Respiratory Society can stimulate clinical research in different disease areas To understand some of the key features of successful disease registries To review key epidemiological, clinical and translational studies of bronchiectasis contributed by the European Multicentre Bronchiectasis Audit and Research Collaboration (EMBARC project in the past 5 years To understand the key research priorities identified by EMBARC for the next 5 years

Efficacy and tolerability of urate-lowering drugs in gout : a randomised controlled trial of benzbromarone versus probenecid after failure of allopurinol

NARCIS (Netherlands)

Reinders, Mattheus; van Roon, E.N.; Jansen, T.L.; Delsing, J.; Griep, E.N.; Hoekstra, M.; van de Laar, M.F.; Brouwers, J.R.

Objectives: To investigate the efficacy and tolerability of allopurinol as the first-choice antihyperuricaemic treatment for gout, and compare the efficacy and tolerability of benzbromarone and probenecid as second-choice treatment. Methods: Prospective, multicentre, open-label, two-stage randomised

Prevention of deep vein thrombosis after hip replacement: randomised comparison between unfractionated heparin and low molecular weight heparin

NARCIS (Netherlands)

Leyvraz, P. F.; Bachmann, F.; Hoek, J.; Büller, H. R.; Postel, M.; Samama, M.; Vandenbroek, M. D.

1991-01-01

To evaluate the efficacy and safety of two subcutaneous prophylactic regimens for postoperative deep vein thrombosis after total hip replacement. Prospective open randomised multicentre trial. 28 European departments of orthopaedic surgery. All patients had bilateral phlebography 10 days after

Differential Item Functioning in the SF-36 Physical Functioning and Mental Health Sub-Scales: A Population-Based Investigation in the Canadian Multicentre Osteoporosis Study.

Science.gov (United States)

Lix, Lisa M; Wu, Xiuyun; Hopman, Wilma; Mayo, Nancy; Sajobi, Tolulope T; Liu, Juxin; Prior, Jerilynn C; Papaioannou, Alexandra; Josse, Robert G; Towheed, Tanveer E; Davison, K Shawn; Sawatzky, Richard

2016-01-01

Self-reported health status measures, like the Short Form 36-item Health Survey (SF-36), can provide rich information about the overall health of a population and its components, such as physical, mental, and social health. However, differential item functioning (DIF), which arises when population sub-groups with the same underlying (i.e., latent) level of health have different measured item response probabilities, may compromise the comparability of these measures. The purpose of this study was to test for DIF on the SF-36 physical functioning (PF) and mental health (MH) sub-scale items in a Canadian population-based sample. Study data were from the prospective Canadian Multicentre Osteoporosis Study (CaMos), which collected baseline data in 1996-1997. DIF was tested using a multiple indicators multiple causes (MIMIC) method. Confirmatory factor analysis defined the latent variable measurement model for the item responses and latent variable regression with demographic and health status covariates (i.e., sex, age group, body weight, self-perceived general health) produced estimates of the magnitude of DIF effects. The CaMos cohort consisted of 9423 respondents; 69.4% were female and 51.7% were less than 65 years. Eight of 10 items on the PF sub-scale and four of five items on the MH sub-scale exhibited DIF. Large DIF effects were observed on PF sub-scale items about vigorous and moderate activities, lifting and carrying groceries, walking one block, and bathing or dressing. On the MH sub-scale items, all DIF effects were small or moderate in size. SF-36 PF and MH sub-scale scores were not comparable across population sub-groups defined by demographic and health status variables due to the effects of DIF, although the magnitude of this bias was not large for most items. We recommend testing and adjusting for DIF to ensure comparability of the SF-36 in population-based investigations.

Differential Item Functioning in the SF-36 Physical Functioning and Mental Health Sub-Scales: A Population-Based Investigation in the Canadian Multicentre Osteoporosis Study.

Directory of Open Access Journals (Sweden)

Lisa M Lix

Full Text Available Self-reported health status measures, like the Short Form 36-item Health Survey (SF-36, can provide rich information about the overall health of a population and its components, such as physical, mental, and social health. However, differential item functioning (DIF, which arises when population sub-groups with the same underlying (i.e., latent level of health have different measured item response probabilities, may compromise the comparability of these measures. The purpose of this study was to test for DIF on the SF-36 physical functioning (PF and mental health (MH sub-scale items in a Canadian population-based sample.Study data were from the prospective Canadian Multicentre Osteoporosis Study (CaMos, which collected baseline data in 1996-1997. DIF was tested using a multiple indicators multiple causes (MIMIC method. Confirmatory factor analysis defined the latent variable measurement model for the item responses and latent variable regression with demographic and health status covariates (i.e., sex, age group, body weight, self-perceived general health produced estimates of the magnitude of DIF effects.The CaMos cohort consisted of 9423 respondents; 69.4% were female and 51.7% were less than 65 years. Eight of 10 items on the PF sub-scale and four of five items on the MH sub-scale exhibited DIF. Large DIF effects were observed on PF sub-scale items about vigorous and moderate activities, lifting and carrying groceries, walking one block, and bathing or dressing. On the MH sub-scale items, all DIF effects were small or moderate in size.SF-36 PF and MH sub-scale scores were not comparable across population sub-groups defined by demographic and health status variables due to the effects of DIF, although the magnitude of this bias was not large for most items. We recommend testing and adjusting for DIF to ensure comparability of the SF-36 in population-based investigations.

Postmenopausal vulvovaginal atrophy (VVA) is positively improved by topical hyaluronic acid application. A prospective, observational study.

Science.gov (United States)

Origoni, M; Cimmino, C; Carminati, G; Iachini, E; Stefani, C; Girardelli, S; Salvatore, S; Candiani, M

2016-10-01

To evaluate the effectiveness of a topical vaginal preparation containing hyaluronic acid in controlling signs and symptoms correlated with postmenopausal vulvovaginal atrophy (VVA). A prospective, observational study has been performed at the Obstetrics and Gynecology Department of the Vita Salute San Raffaele University of Milan, Italy. Forty-six (46) consecutive postmenopausal women complaining of genital discomfort due to postmenopausal estrogen lack have been enrolled. All patients have been investigated by the use of the Vaginal Health Index (VHI) and of a Visual Analogic Scale (VAS) of symptoms at baseline and one month after the end of the study. The treatment protocol consisted of the administration of a hyaluronic acid-based liquid preparation for vaginal use (Justgin®, Just Pharma, Rome, Italy) three times a week, for a total of 8 weeks. Statistical analysis of VHI and VAS scores has been performed by the use of the Wilcoxon signed-rank test for repeated values, assuming a p-value Hyaluronic acid topical approach with a liquid preparation for vaginal use (Justgin®, Just Pharma, Roma, Italy) to control signs and symptoms of vulvovaginal atrophy (VVA) in postmenopausal women demonstrated significant effectiveness both in terms of objective and subjective improvement.

An open-label, prospective, observational study of the efficacy of bisphosphonate therapy for painful osteoid osteoma

Energy Technology Data Exchange (ETDEWEB)

Bousson, Valerie; Parlier-Cuau, Caroline; Laredo, Jean-Denis [AP-HP, Hopital Lariboisiere, Service de Radiologie Osteo-Articulaire, Paris (France); Universite Paris Diderot, Sorbonne Paris Cite, Paris (France); Leturcq, Tifenn; Ea, Hang-Korng; Orcel, Philippe [AP-HP, Hopital Lariboisiere, Service de Rhumatologie, Paris (France); Universite Paris Diderot, Sorbonne Paris Cite, Paris (France); Hauger, Olivier [CHU Pellegrin Bordeaux, Service d' Imagerie Diagnostique et Therapeutique de l' Adulte, Bordeaux (France); Mehsen-Cetre, Nadia; Schaeverbeke, Thierry [CHU Pellegrin Bordeaux, Service de Rhumatologie, Bordeaux (France); Hamze, Bassam [AP-HP, Hopital Lariboisiere, Service de Radiologie Osteo-Articulaire, Paris (France)

2018-02-15

To assess the efficacy of bisphosphonate therapy on bone pain in patients with osteoid osteoma (OO) (main objective), and to describe bisphosphonate-induced changes in nidus mineralisation and regional bone-marrow oedema (BMO). A prospective, observational study was conducted from 2011 to 2014. Patients with risk factors for complications of percutaneous or surgical ablation or recurrence after ablation, were offered once monthly intravenous bisphosphonate treatment until significant pain alleviation was achieved. We included 23 patients. The first two patients received pamidronate and the next 21 zoledronic acid (mean, 2.95 infusions per patient). Bisphosphonate therapy was successful in 19 patients (83%), whose mean pain visual analogue scale score decreased by 76.7%; this pain-relieving effect persisted in 17 patients (74%) with a mean follow-up time of 36 months. Computed tomography (CT) demonstrated a mean nidus density increase of 177.7% (p = 0.001). By magnetic resonance imaging (MRI), mean decreases were 38.4% for BMO surface area and 30.3% for signal intensity (p = 0.001 and p = 0.000, respectively). In 17/23 patients with painful OO managed conservatively with bisphosphonates, long-term final success was achieved. Bisphosphonates may accelerate the spontaneous healing of OO. (orig.)

Relationship between method of anastomosis and anastomotic failure after right hemicolectomy and ileo-caecal resection: an international snapshot audit

NARCIS (Netherlands)

Pinkney, T.; Battersby, N.; Bhangu, A.; Chaudhri, S.; El-Hussuna, A.; Frasson, M.; Nepogodiev, D.; Singh, B.; Vennix, S.; Zmora, O.; Altomare, D.; Bemelman, W.; Christensen, P.; D'Hoore, A.; Laurberg, S.; Morton, D.; Rubbini, M.; Vaizey, C.; Magill, L.; Perry, R.; Sheward, N.; Ives, N.; Mehta, S.; Cillo, M.; Estefania, D.; Patron Uriburu, J.; Ruiz, H.; Salomon, M.; Makhmudov, A.; Selnyahina, L.; Varabei, A.; Vizhynis, Y.; Claeys, D.; Defoort, B.; Muysoms, F.; Pletinckx, P.; Vergucht, V.; Debergh, I.; Feryn, T.; Reusens, H.; Nachtergaele, M.; Francart, D.; Jehaes, C.; Markiewicz, S.; Monami, B.; Weerts, J.; Bouckaert, W.; Houben, B.; Knol, J.; Sergeant, G.; Vangertruyden, G.; Haeck, L.; Lange, C.; Sommeling, C.; Vindevoghel, K.; Castro, S.; de Bruyn, H.; Huyghe, M.; de Wolf, E.; Reynders, D.; van Overstraeten, A. de Buck; Wolthuis, A.; Delibegovic, S.; Christiani, A.; Marchiori, M.; Rocha de Moraes, C.; Tercioti, V.; Arabadjieva, E.; Bulanov, D.; Dardanov, D.; Stoyanov, V.; Yonkov, A.; Angelov, K.; Maslyankov, S.; Sokolov, M.; Todorov, G.; Toshev, S.; Georgiev, Y.; Karashmalakov, A.; Zafirov, G.; Wang, X.; Condic, D.; Kraljik, D.; Mrkovic, H.; Pavkovic, V.; Raguz, K.; Bencurik, V.; Holaskova, E.; Skrovina, M.; Farkasova, M.; Grolich, T.; Kala, Z.; Antos, F.; Pruchova, V.; Sotona, O.; Chobola, M.; Dusek, T.; Ferko, A.; Orhalmi, J.; Hoch, J.; Kocian, P.; Martinek, L.; Bernstein, I.; Sunesen, K. Gotschalck; Leunbach, J.; Thorlacius-Ussing, O.; Oveson, A. Uth; Chirstensen, S. Dahl; Gamez, V.; Oeting, M.; Loeve, U. Schou; Ugianskis, A.; Jessen, M.; Krarup, P.; Linde, K.; Mirza, Q.; Stovring, J. Overgaard; Erritzoe, L.; Jakobsen, H. Loft; Lykke, J.; Colov, E. Palmgren; Madsen, A. Husted; Friis, T. Linde; Funder, J. Amstrup; Dich, R.; Kjaer, S.; Rasmussen, S.; Schlesinger, N.; Kjaer, M. Dilling; Qvist, N.; Khalid, A.; Ali, G.; Hadi, S.; Walker, L. Rosell; Kivela, A.; Lehtonen, T.; Lepisto, A.; Scheinin, T.; Siironen, P.; Kossi, J.; Kuusanmaki, P.; Tomminen, T.; Turunen, A.; Rautio, T.; Vierimaa, M.; Huhtinen, H.; Karvonen, J.; Lavonius, M.; Rantala, A.; Varpe, P.; Cotte, E.; Francois, Y.; Glehen, O.; Kepenekian, V.; Passot, G.; Maggiori, L.; Manceau, G.; Panis, Y.; Gout, M.; Rullier, E.; van Geluwe, B.; Chafai, N.; Lefevre, J. H.; Parc, Y.; Tiret, E.; Couette, C.; Duchalais, E.; Agha, A.; Hornberger, M.; Hungbauer, A.; Iesalnieks, I.; Weindl, I.; Crescenti, F.; Keller, M.; Kolodziejski, N.; Scherer, R.; Sterzing, D.; Bock, B.; Boehm, G.; El-Magd, M.; Krones, C.; Niewiera, M.; Buhr, J.; Cordesmeyer, S.; Hoffmann, M.; Krueckemeier, K.; Vogel, T.; Schoen, M.; Baral, J.; Lukoschek, T.; Muench, S.; Pullig, F.; Horisberger, K.; Kienle, P.; Magdeburg, J.; Post, S.; Batzalexis, K.; Germanos, S.; Agalianos, C.; Dervenis, C.; Gouvas, N.; Kanavidis, P.; Kottikias, A.; Katsoulis, I. E.; Korkolis, D.; Plataniotis, G.; Sakorafas, G.; Akrida, I.; Argentou, M.; Kollatos, C.; Lampropoulos, C.; Tsochatzis, S.; Besznyak, I.; Bursics, A.; Egyed, T.; Papp, G.; Svastics, I.; Atladottir, J.; Moller, P.; Sigurdsson, H.; Stefansson, T.; Valsdottir, E.; Andrews, E.; Foley, N.; Hechtl, D.; Majeed, M.; McCourt, M.; Hanly, A.; Hyland, J.; Martin, S.; O'Connell, P. R.; Winter, D.; Connelly, T.; Joyce, W.; Wrafter, P.; Berkovitz, R.; Avital, S.; Yahia, I. Haj; Hermann, N.; Shpitz, B.; White, I.; Lishtzinsky, Y.; Tsherniak, A.; Wasserberg, N.; Horesh, N.; Keler, U.; Pery, R.; Shapiro, R.; Tulchinsky, H.; Badran, B.; Dayan, K.; Iskhakov, A.; Lecaros, J.; Nabih, N.; Angrima, I.; Bardini, R.; Pizzolato, E.; Tonello, M.; Arces, F.; Balestri, R.; Ceccarelli, C.; Prosperi, V.; Rossi, E.; Giannini, I.; Vincenti, L.; Altomare, D. F.; Di Candido, F.; Di Iena, M.; Guglielmi, A.; Caputi-Iam-Brenghi, O.; Marsanic, P.; Mellano, A.; Muratore, A.; Annecchiarico, M.; Bencini, L.; Bona-Pasta, S. Amore; Coratti, A.; Guerra, F.; Asteria, C. R.; Boccia, L.; Gerard, L.; Pascariello, A.; Manca, G.; Marino, F.; Casaril, A.; Inama, M.; Moretto, G.; Bacchelli, C.; Carvello, M.; Mariani, N.; Montorsi, M.; Spinelli, A.; Romairone, E.; Scabini, S.; Belli, A.; Bianco, F.; de Franciscis, S.; Romano, G. Maria; Delrio, P.; Pace, U.; Rega, D.; Sassaroli, C.; Scala, D.; de Luca, R.; Ruggieri, E.; Elbetti, C.; Garzi, A.; Romoli, L.; Scatizzi, M.; Vannucchi, A.; Curletti, G.; Durante, V.; Galleano, R.; Mariani, F.; Reggiani, L.; Bellomo, R.; Infantino, A.; Franceschilli, L.; Sileri, P.; Clementi, I.; Coletta, D.; La Torre, F.; Mingoli, A.; Velluti, F.; Di Giacomo, A.; Fiorot, A.; Massani, M.; Padoan, L.; Ruffolo, C.; Caruso, S.; Franceschini, F.; Laessig, R.; Monaci, I.; Rontini, M.; de Nardi, P.; Elmore, U.; Lemma, M.; Rosati, R.; Tamburini, A.; de Luca, M.; Sartori, A.; Benevento, A.; Bottini, C.; Ferrari, C. C.; Pata, F.; Tessera, G.; Pellino, G.; Selvaggi, F.; Lanzani, A.; Romano, F.; Sgroi, G.; Steccanella, F.; Turati, L.; Yamamoto, T.; Ancans, G.; Gerkis, S.; Leja, M.; Pcolkins, A.; Sivins, A.; Latkauskas, T.; Lizdenis, P.; Saladzin-Skas, Z.; Svagzdys, S.; Tamelis, A.; Razbadauskas, A.; Sokolovas, M.; Dulskas, A.; Samalavicius, N.; Jotautas, V.; Mikalauskas, S.; Poskus, E.; Poskus, T.; Strupas, K.; Camenzuli, C.; Cini, C.; Predrag, A.; Psaila, J.; Spiteri, N.; Buskens, C.; de Groof, E. J.; Gooszen, J.; Tanis, P.; Belgers, E.; Davids, P.; Furnee, E.; Postma, E.; Pronk, A.; Smakman, N.; Clermonts, S.; Zimmerman, D.; Omloo, J.; van der Zaag, E.; van Duijvendijk, P.; Wassenaar, E.; Bruijninckx, M.; de Graff, E.; Doornebosch, P.; Tetteroo, G.; Vermaas, M.; Iordens, G.; Knops, S.; Toorenvliet, B.; van Westereenen, H. L.; Boerma, E.; Coene, P.; van der Harst, E.; van der Pool, A.; Raber, M.; Melenhorst, J.; de Castro, S.; Gerhards, M.; Arron, M.; Bremers, A.; de Wilt, H.; Ferenschild, F.; Yauw, S.; Cense, H.; Demirkiran, A.; Hunfeld, M.; Mulder, I.; Nonner, J.; Swank, H.; van Wagensveld, B.; Bolmers, M.; Briel, J.; van Geloven, A.; van Rossem, C.; Klemann, V.; Konsten, J.; Leenders, B.; Schok, T.; Bleeker, W.; Brun, M.; Helgeland, M.; Ignjatovic, D.; Oresland, T.; Yousefi, P.; Backe, I. Faten; Sjo, O. Helmer; Nesbakken, A.; Tandberg-Eriksen, M.; Cais, A.; Traeland, J. Hallvard; Herikstad, R.; Korner, H.; Lauvland, N.; Jajtner, D.; Kabiesz, W.; Rak, M.; Gmerek, L.; Horbacka, K.; Horst, N.; Krokowicz, P.; Kwiatkowski, A.; Pasnik, K.; Karcz, P.; Romaniszyn, M.; Rusek, T.; Walega, P.; Czarencki, R.; Obuszko, Z.; Sitarska, M.; Wojciech, W.; Zawadzki, M.; Amado, S.; Clara, P.; Couceiro, A.; Malaquias, R.; Rama, N.; Almeida, A.; Barbosa, E.; Cernadas, E.; Duarte, A.; Silva, P.; Costa, S.; Martinez Insua, C.; Pereira, J.; Pereira, C.; Sacchetti, M.; Carvalho Pinto, B.; Vieira Sousa, P. Jorge; Marques, R.; Oliveira, A.; Cardoso, R.; Carlos, S.; Corte-Real, J.; Moniz Pereira, P.; Souto, R.; Carneiro, C.; Marinho, R.; Nunes, V.; Rocha, R.; Sousa, M.; Leite, J.; Melo, F.; Pimentel, J.; Ventura, L.; Vila Nova, C.; Copacscu, C.; Bintintan, V.; Ciuce, C.; Dindelegan, G.; Scurtu, R.; Seicean, R.; Domansky, N.; Karachun, A.; Moiseenko, A.; Pelipas, Y.; Petrov, A.; Pravosudov, I.; Aiupov, R.; Akmalov, Y.; Parfenov, A.; Suleymanov, N.; Tarasov, N.; Jumabaev, H.; Mamedli, Z.; Rasulov, A.; Aliev, I.; Chernikovskiy, I.; Kochnev, V.; Komyak, K.; Smirnov, A.; Achkasov, S.; Bolikhov, K.; Shelygin, Y.; Sushkov, O.; Zapolskiy, A.; Gvozdenovic, M.; Jovanovic, D.; Lausevic, Z.; Cvetkovic, D.; Maravic, M.; Milovanovic, B.; Stojakovic, N.; Tripkovic, I.; Mihajlovic, D.; Nestorovic, M.; Pecic, V.; Petrovic, D.; Stanojevic, G.; Barisic, G.; Dimitrijevic, I.; Krivokapic, Z.; Markovic, V.; Popovic, M.; Aleksic, A.; Dabic, D.; Kostic, I.; Milojkovic, A.; Perunicic, V.; Lukic, D.; Petrovic, T.; Radovanovic, D.; Radovanovic, Z.; Cuk, V. M.; Cuk, V. V.; Kenic, M.; Kovacevic, B.; Krdzic, I.; Korcek, J.; Rems, M.; Toplak, J.; Escarra, J.; Gil Barrionuevo, M.; Golda, T.; Kreisler Moreno, E.; Zerpa Martin, C.; Alvarez Laso, C.; Cumplido, P.; Padin, H.; Baixauli Fons, J.; Hernandez-Lizoain, J.; Martinez-Ortega, P.; Molina-Fernandez, M.; Sanchez-Justicia, C.; Gracia Solanas, J. Antonio; Diaz de laspra, E. Cordoba; Echazarreta-Gallego, E.; Elia-Guedea, M.; Ramirez, J.; Arredondo Chaves, J.; Gonzalez, P. Diez; Elosua, T.; Sahagun, J.; Turienzo Frade, A.; Alvarez Conde, J.; Castrillo, E.; Diaz Maag, R.; Maderuelo, V.; Saldarriaga, L.; Aldrey Cao, I.; Fernandez Varela, X.; Nunez Fernandez, S.; Parajo Calvo, A.; Villar Alvarez, S.; Blesa Sierra, I.; Lozano, R.; Marquez, M.; Porcel, O.; Menendez, P.; Fernandez Hevia, M.; Flores Siguenza, L.; Jimenez Toscano, M.; Lacy Fortuny, A.; Ordonez Trujillo, J.; Espi, A.; Garcia-Botello, S.; Martin-Arevalo, J.; Moro-Valdezate, D.; Pla-Marti, V.; Blanco-Antona, F.; Abrisqueta, J.; Ibanez Canovas, N.; Lujan Mompean, J.; Escola Ripoll, D.; Martinez Gonzalez, S.; Parodi, J.; Fernandez Lopez, A.; Ramos Fernandez, M.; Castellvi Valls, J.; Ortiz de Zarate, L.; Ribas, R.; Sabia, D.; Viso, L.; Alonso Goncalves, S.; Gil Egea, M. Jose; Pascual Damieta, M.; Pera, M.; Salvans Ruiz, S.; Bernal, J.; Landete, F.; Ais, G.; Etreros, J.; Aguilo Lucia, J.; Bosca, A.; Deusa, S.; Garcia del Cano, J.; Viciano, V.; Garcia-Armengol, J.; Roig, J.; Blas, J.; Escartin, J.; Fatas, J.; Fernando, J.; Ferrer, R.; Arias Pacheco, R.; Garcia Florez, L.; Moreno Gijon, M.; Otero Diez, J.; Solar Garcia, L.; Aguilar Teixido, F.; Balaguer Ojo, C.; Bargallo Berzosa, J.; Lamas Moure, S.; Sierra, J. Enrique; Ferminan, A.; Herrerias, F.; Rufas, M.; Vinas, J.; Codina-Cazador, A.; Farres, R.; Gomez, N.; Julia, D.; Planellas, P.; Lopez, J.; Luna, A.; Maristany, C.; Munoz Duyos, A.; Puertolas, N.; Alcantara Moral, M.; Serra-Aracil, X.; Concheiro Coello, P.; Gomez, D.; Carton, C.; Miguel, A.; Reoyo Pascual, F.; Valero Cerrato, X.; Zambrano Munoz, R.; Cervera-Aldama, J.; Gonzalez, J. Garcia; Ramos-Prada, J.; Santamaria-Olabarrieta, M.; Uriguen-Echeverria, A.; Coves Alcover, R.; Espinosa Soria, J.; Fernandez Rodriguez, E.; Hernandis Villalba, J.; Maturana Ibanenz, V.; de la Torre Gonzalez, F.; Huerga, D.; Perez Viejo, E.; Rivera, A.; Ruiz Ucar, E.; Garcia-Septiem, J.; Jimenez, V.; Jimenez Miramon, J.; Ramons Rodriquez, J.; Rodriguez Alvarez, V.; Garcea, A.; Ponchietti, L.; Borda, N.; Enriquez-Navascues, J.; Saralegui, Y.; Febles Molina, G.; Nogues, E.; Rodriguez Mendez, A.; Roque Castellano, C.; Sosa Quesada, Y.; Alvarez-Gallego, M.; Pascual, I.; Rubio-Perez, I.; Diaz-San Andres, B.; Tone-Villanueva, F.; Alonso, J.; Cagigas, C.; Castillo, J.; gomez, M.; Martin-Parra, J.; Mengual Ballester, M.; Pellicer Franco, E.; Soria Aledo, V.; Valero Navarro, G.; Caballero Rodriguez, E.; Gonzalez de Chaves, P.; Hernandez, G.; Perez Alvarez, A.; Soto Sanchez, A.; Becerra Garcia, F. Cesar; Alonso Roque, J. Guillermo; Rodriguez Arias, F. Lopez; del Valle Ruiz, S. R.; Sanchez de la Villa, G.; Compan, A.; Garcia Marin, A.; Nofuentes, C.; Orts Mico, F.; Perez Auladell, V.; Carrasco, M.; Duque Perez, C.; Galvez-Pastor, S.; Navarro Garcia, I.; Sanchez Perez, A.; Enjuto, D.; Manuel Bujalance, F.; Marcelin, N.; Perez, M.; Serrano Garcia, R.; Cabrera, A.; de la Portilla, F.; Diaz-Pavon, J.; Jimenez-Rodriguez, R.; Vazquez-Monchul, J.; Daza Gonzalez, J.; Gomez Perez, R.; Rivera Castellano, J.; Roldan de la Rua, J.; Errasti Alustiza, J.; Fernandez, L.; Romeo Ramirez, J.; Sardon Ramos, J.; Cermeno Toral, B.; Alias, D.; Garcia-Olmo, D.; Guadalajara, H.; Herreros, M.; Pacheco, P.; del Castillo Diez, F.; Lima Pinto, F.; Martinez Alegre, J.; Ortega, I.; Nieto Antonio, A. Picardo; Caro, A.; Escuder, J.; Feliu, F.; Millan, M.; Alos Company, R.; Frangi Caregnato, A.; Lozoya Trujillo, R.; Rodriguez Carrillo, R.; Ruiz Carmona, M.; Alonso, N.; Ambrona Zafra, D.; Ayala Candia, B. Amilka; Bonnin Pascual, J.; Pineno Flores, C.; Alcazar Montero, J.; Angoso Clavijo, M.; Garcia, J.; Sanchez Tocino, J.; Gomez-Alcazar, C.; Costa-Navarro, D.; Ferri-Romero, J.; Rey-Riveiro, M.; Romero-Simo, M.; Arencibia, B.; Esclapez, P.; Garcia-Granero, E.; Granero, P.; Medina Fernandez, F. J.; Gallardo Herrera, A. B.; Diaz Lopez, C.; Navarro Rodriguez, E.; Torres Tordera, E.; Arenal, J.; Citores, M.; Marcos, J.; Sanchez, J.; Tinoco, C.; Espin, E.; Garcia Granero, A.; Jimenez Gomez, L.; Sanchez Garcia, J.; Vallribera, F.; Folkesson, J.; Skoldberg, F.; Bergman, K.; Borgstrom, E.; Frey, J.; Silfverberg, A.; Soderholm, M.; Nygren, J.; Segelman, J.; Gustafsson, D.; Lagerqvist, A.; Papp, A.; Pelczar, M.; Abraham-Nordling, M.; Ahlberg, M.; Sjovall, A.; Tengstrom, J.; Hagman, K.; Chabok, A.; Ezra, E.; Nikberg, M.; Smedh, K.; Tiselius, C.; Al-Naimi, N.; Duc, M. Dao; Meyer, J.; Mormont, M.; Ris, F.; Prevost, G.; Villiger, P.; Hoffmann, H.; Kettelhack, C.; Kirchhoff, P.; Oertli, D.; Weixler, B.; Aytac, B.; Leventoglu, S.; Mentes, B.; Yuksel, O.; Demirbas, S.; Ozkan, B. Busra; Ozbalci, G. Selcuk; Sungurtekin, U.; Gulcu, B.; Ozturk, E.; Yilmazlar, T.; Challand, C.; Fearnhead, N.; Hubbard, R.; Kumar, S.; Arthur, J.; Barben, C.; Skaife, P.; Slawik, S.; Williams, M.; Zammit, M.; Barker, J.; French, J.; Sarantitis, I.; Slawinski, C.; Clifford, R.; Eardley, N.; Johnson, M.; McFaul, C.; Vimalachandran, D.; Allan, S.; Bell, A.; Oates, E.; Shanmugam, V.; Brigic, A.; Halls, M.; Pucher, P.; Stubbs, B.; Agarwal, T.; Chopada, A.; Mallappa, S.; Pathmarajah, M.; Sugden, C.; Brown, C.; Macdonald, E.; Mckay, A.; Richards, J.; Robertson, A.; Kaushal, M.; Patel, P.; Tezas, S.; Touqan, N.; Ayaani, S.; Marimuthu, K.; Piramanayagam, B.; Vourvachis, M.; Iqbal, N.; Korsgen, S.; Seretis, C.; Shariff, U.; Arnold, S.; Chan, H.; Clark, E.; Fernandes, R.; Moran, B.; Bajwa, A.; McArthur, D.; Cao, K.; Cunha, P.; Pardoe, H.; Quddus, A.; Theodoropoulou, K.; Bolln, C.; Denys, G.; Gillespie, M.; Manimaran, N.; Reidy, J.; Malik, A. I.; Malik, A.; Pitt, J.; Aryal, K.; El-Hadi, A.; Lal, R.; Pal, A.; Velchuru, V.; Cunha, M. Oliveira; Thomas, M.; Bains, S.; Boyle, K.; Miller, A.; Norwood, M.; Yeung, J.; Goian, L.; Gurjar, S.; Saghir, W.; Sengupta, N.; Stewart-Parker, E.; Bailey, S.; Khalil, T.; Lawes, D.; Nikolaou, S.; Omar, G.; Church, R.; Muthiah, B.; Garrett, W.; Marsh, P.; Obeid, N.; Chandler, S.; Coyne, P.; Evans, M.; Hunt, L.; Lim, J.; Oliphant, Z.; Papworth, E.; Weaver, H.; Leon, K. Cuinas; Williams, G.; Hernon, J.; Kapur, S.; Moosvi, R.; Shaikh, I.; Swafe, L.; Aslam, M.; Evans, J.; Ihedioha, U.; Kang, P.; Merchant, J.; Hompes, R.; Middleton, R.; Broomfield, A.; Crutten-Wood, D.; Foster, J.; Nash, G.; Akhtar, M.; Boshnaq, M.; Eldesouky, S.; Mangam, S.; Rabie, M.; Ahmed, J.; Khan, J.; Goh, N. Ming; Shamali, A.; Stefan, S.; Thompson, C.; Amin, A.; Docherty, J.; Lim, M.; Walker, K.; Watson, A.; Hossack, M.; Mackenzie, N.; Paraoan, M.; Alam, N.; Daniels, I.; Narang, S.; Pathak, S.; Smart, N.; Al-Qaddo, A.; Codd, R.; Rutka, O.; Bronder, C.; Crighton, I.; Davies, E.; Raymond, T.; Bookless, L.; Griffiths, B.; Plusa, S.; Carlson, G.; Harrison, R.; Lees, N.; Mason, C.; Quayle, J.; Branagan, G.; Broadhurst, J.; Chave, H.; Sleight, S.; Awad, F.; Cruickshank, N.; Joy, H.; Boereboom, C.; Daliya, P.; Dhillon, A.; Watson, N.; Watson, R.; Artioukh, D.; Gokul, K.; Javed, M.; Kong, R.; Sutton, J.; Faiz, O.; Jenkins, I.; Leo, C. A.; Samaranayake, S. F.; Warusavitarne, J.; Arya, S.; Bhan, C.; Mukhtar, H.; Oshowo, A.; Wilson, J.; Duff, S.; Fatayer, T.; Mbuvi, J.; Sharma, A.; Cornish, J.; Davies, L.; Harries, R.; Morris, C.; Torkington, J.; Knight, J.; Lai, C.; Shihab, O.; Tzivanakis, A.; Hussain, A.; Luke, D.; Padwick, R.; Torrance, A.; Tsiamis, A.; Dawson, P.; Balfour, A.; Brady, R.; Mander, J.; Paterson, H.; Chandratreya, N.; Chu, H.; Cutting, J.; Vernon, S.; Ho, C. Wai; Andreani, S.; Patel, H.; Warner, M.; Tan, J. Yan Qi; Gidwani, A.; Lawther, R.; Loughlin, P.; Skelly, B.; Spence, R.; Iqbal, A.; Khan, A.; Perrin, K.; Raza, A.; Tan, S.

2017-01-01

Aim The anastomosis technique used following right-sided colonic resection is widely variable and may affect patient outcome. This study aimed to assess the association between leak and anastomosis technique (stapled vs handsewn). Method This was a prospective, multicentre, international audit

Effect of a ward-based pharmacy team on preventable adverse drug events in surgical patients (SUREPILL study)

NARCIS (Netherlands)

de Boer, M.; Boeker, E. B.; Ramrattan, M. A.; Kiewiet, J. J. S.; Ram, K.; Gombert-Handoko, K. B.; van Lent-Evers, N. A. E. M.; Kuks, P. F. M.; Mulder, W. M. C.; Breslau, P. J.; Oostenbroek, R. J.; Dijkgraaf, M. G. W.; Lie-A-Huen, L.; Boermeester, M. A.

2015-01-01

Surgical patients are at risk of adverse drug events (ADEs) causing morbidity and mortality. Much harm is preventable. Ward-based pharmacy interventions to reduce medication-related harm have not been evaluated in surgical patients. This multicentre prospective clinical trial evaluated a

Effect of various antithrombotic regimens (aspirin, aspirin plus dipyridamole, anticoagulants) on the functional status of patients and grafts one year after coronary artery bypass grafting

NARCIS (Netherlands)

Mulder, B. J.; van der Doef, R. M.; van der Wall, E. E.; Tijssen, J. G.; Piek, J. J.; van der Meer, J.; Dunning, A. J.

1994-01-01

From 1987 until 1991 a large prospective randomized multicentre study was performed in The Netherlands, Germany and Switzerland entitled CABADAS (Prevention of Coronary Artery Bypass graft occlusion by Aspirin, Dipyridamole, and Acenocoumarol/Phenprocoumon Study). The aim of CABADAS was to evaluate

Distinguishing benign and malignant pelvic masses : The value of different diagnostic methods in everyday clinical practice

NARCIS (Netherlands)

Engelen, Mirjam J. A.; Bongaerts, Alphons H. H.; Sluiter, Wim J.; De Haan, Harm H.; Bogchelman, Dick H.; TenVergert, Els M.; Willemse, Pax H. B.; van der Zee, Ate G. J.

Objective: To optimize referral to specialized gynaecologists for surgical treatment of ovarian cancer by improving preoperative discrimination between benign and malignant pelvic tumours. Study design: In a prospective multicentre study 143 patients with a pelvic mass were included. At several

Uranium prospecting; La prospection de l'uranium

Energy Technology Data Exchange (ETDEWEB)

Roubault, M [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

1955-07-01

This report is an instruction book for uranium prospecting. It appeals to private prospecting. As prospecting is now a scientific and technical research, it cannot be done without preliminary studies. First of all, general prospecting methods are given with a recall of fundamental geologic data and some general principles which are common with all type of prospecting. The peculiarities of uranium prospecting are also presented and in particular the radioactivity property of uranium as well as the special aspect of uranium ores and the aspect of neighbouring ores. In a third part, a description of the different uranium ores is given and separated in two different categories: primary and secondary ores, according to the place of transformation, deep or near the crust surface respectively. In the first category, the primary ores include pitchblende, thorianite and rare uranium oxides as euxenite and fergusonite for example. In the second category, the secondary ores contain autunite and chalcolite for example. An exhaustive presentation of the geiger-Mueller counter is given with the presentation of its different components, its functioning and utilization and its maintenance. The radioactivity interpretation method is showed as well as the elaboration of a topographic map of the measured radioactivity. A brief presentation of other detection methods than geiger-Mueller counters is given: the measurement of fluorescence and a chemical test using the fluorescence properties of uranium salts. Finally, the main characteristics of uranium deposits are discussed. (M.P.)

Postural and Balance Disorders in Patients with Parkinson’s Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

Directory of Open Access Journals (Sweden)

Andrea Santamato

2015-01-01

Full Text Available Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson’s disease (PD to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients.

A prospective observational longitudinal study of new-onset seizures and newly diagnosed epilepsy in dogs

DEFF Research Database (Denmark)

Fredsø, N; Toft, Nils; Sabers, A.

2017-01-01

Seizures are common in dogs and can be caused by non-epileptic conditions or epilepsy. The clinical course of newly diagnosed epilepsy is sparsely documented. The objective of this study was to prospectively investigate causes for seizures (epileptic and non-epileptic) in a cohort of dogs with ne...

Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857

Directory of Open Access Journals (Sweden)

Montgomery Ken

2008-01-01

Full Text Available Abstract Background Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. Methods/Design In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

Energy Technology Data Exchange (ETDEWEB)

Prince, Martin R. [Weill Cornell Medical College, Department of Radiology, New York, NY (United States); Columbia College of Physicians and Surgeons, Department of Radiology, New York, NY (United States); Lee, Hae Giu [Seoul St. Mary' s Hospital, The Catholic University of Korea, College of Medicine, Department of Radiology, Seoul (Korea, Republic of); Lee, Chang-Hee [Korea University Guro Hospital, Department of Radiology, Seoul (Korea, Republic of); Youn, Sung Won [Catholic University of Daegu Medical Center, Department of Radiology, Daegu (Korea, Republic of); Lee, In Ho [Chungnam National University Hospital, Chungnam National University School of Medicine, Department of Radiology, Daejeon (Korea, Republic of); Yoon, Woong [Chonnam National University Hospital, Department of Radiology, Gwangju (Korea, Republic of); Yang, Benqiang [General Hospital of Shenyang Military Region, Department of Radiology, Shenyang (China); Wang, Haiping [Tangshan Worker' s Hospital, Department of Radiology, Tangshan (China); Wang, Jin [Third Affiliated Hospital of Sun Yat-Sen University, Department of Radiology, Guangzhou (China); Shih, Tiffany Ting-fang [National Taiwan University, Medical College and Hospital, Department of Radiology and Medical Imaging, Taipei (China); Huang, Guo-Shu [National Defense Medical Center, Department of Radiology, Tri-Service General Hospital, Taipei (China); Lirng, Jiing-Feng [Taipei Veterans General Hospital, Department of Radiology, Taipei (China); Palkowitsch, Petra [Medical and Clinical Affairs Radiology, Bayer Pharmaceutical Division, Berlin (Germany); Collaboration: on behalf of the GARDIAN study group

2017-01-15

To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting. GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events. Median gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications. The GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population. (orig.)

Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

International Nuclear Information System (INIS)

Prince, Martin R.; Lee, Hae Giu; Lee, Chang-Hee; Youn, Sung Won; Lee, In Ho; Yoon, Woong; Yang, Benqiang; Wang, Haiping; Wang, Jin; Shih, Tiffany Ting-fang; Huang, Guo-Shu; Lirng, Jiing-Feng; Palkowitsch, Petra

2017-01-01

To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting. GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events. Median gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications. The GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population. (orig.)

Accumulation of advanced glycation end (AGEs products in intensive care patients: an observational, prospective study

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Rommes Johannes H

2010-05-01

Full Text Available Abstract Background Oxidative stress plays an important role in the course and eventual outcome in a majority of patients admitted to the intensive care unit (ICU. Markers to estimate oxidative stress are not readily available in a clinical setting. AGEs accumulation has been merely described in chronic conditions, but can also occur acutely due to oxidative stress. Since AGEs have emerged to be stable end products, these can be a marker of oxidative stress. Skin autofluorescence (AF is a validated marker of tissue content of AGEs. We hypothesized that AGEs accumulate acutely in ICU patients. Methods We performed an observational prospective study in a medical surgical ICU in a university affiliated teaching hospital. All consecutively admitted ICU patients in a 2 month period were included. Skin AF was measured using an AGE reader in 35 consecutive ICU patients > 18 yrs. As a comparison, historical data of a control group (n = 231 were used. These were also used to calculate age-adjusted AF-levels (AFadj. Values are expressed as median and interquartile range [P25-P75]. Differences between groups were tested by non parametric tests. P Results AFadj values were higher in ICU patients (0.33 [0.00 - 0.68] than in controls (-0.07 [-0.29 - 0.24]; P adj were observed between acute or planned admissions, or presence of sepsis, nor was skin AFadj related to severity of disease as estimated by APACHE-II score, length of ICU, hospital stay or mortality. Conclusion Acute AGE accumulation in ICU patients was shown in this study, although group size was small. This can possibly reflect oxidative stress in ICU patients. Further studies should reveal whether AGE-accumulation will be a useful parameter in ICU patients and whether skin AF has a predictive value for outcome, which was not shown in this small study.

Perfusion index as a predictor of hypotension following propofol induction - A prospective observational study

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Sripada G Mehandale

2017-01-01

Full Text Available Background and Aims: Hypotension during propofol induction is a common problem. Perfusion index (PI, an indicator of systemic vascular resistance, is said to be predictive of hypotension following subarachnoid block. We hypothesised that PI can predict hypotension following propofol induction and a cut-off value beyond which hypotension is more common can be determined. Methods: Fifty adults belonging to the American Society of Anesthesiologists' physical status I/II undergoing elective surgery under general anaesthesia were enrolled for this prospective, observational study. PI, heart rate, blood pressure (BP and oxygen saturation were recorded every minute from baseline to 10 min following induction of anaesthesia with a titrated dose of propofol, and after endotracheal intubation. Hypotension was defined as fall in systolic BP (SBP by >30% of baseline or mean arterial pressure (MAP to <60 mm Hg. Severe hypotension (MAP of <55 mm Hg was treated. Results: Within first 5-min after induction, the incidence of hypotension with SBP and MAP criteria was 30% and 42%, respectively, and that of severe hypotension, 22%. Baseline PI <1.05 predicted incidence of hypotension at 5 min with sensitivity 93%, specificity 71%, positive predictive value (PPV 68% and negative predictive value (NPV 98%. The area under the ROC curve (AUC was 0.816, 95% confidence interval (0.699–0.933, P < 0.001 Conclusion: Perfusion index could predict hypotension following propofol induction, especially before endotracheal intubation, and had a very high negative predictive value.

[Cinacalcet in the management of normocalcaemic secondary hyperparathyroidism after kidney transplantation: one-year follow-up multicentre study].

Science.gov (United States)

Torregrosa, Josep V; Morales, Enrique; Díaz, Juan M; Crespo, Josep; Bravo, Juan; Gómez, Gonzalo; Gentil, Miguel A; Rodríguez-Benot, Alberto; Rodríguez-García, Minerva; López-Jiménez, Verónica; Gutiérrez-Dalmau, Álex; Jimeno, Luisa; Pérez-Sáez, M José; Romero, Rafael; Gómez-Alamillo, Carlos

2014-01-01

The effect of cinacalcet in patients with persistent secondary hyperparathyroidism (SHPT) after kidney transplantation (RT) has mainly been reported in patients with secondary hypercalcaemia. Our objective was to assess the long-term effect of cinacalcet on patients with a RT and normocalcaemic SHPT. A one-year multicentre, observational, retrospective study that included kidney recipients with SHPT (intact parathyroid hormone [iPTH] >120 pg/ml) and calcium levels within the normal range (8.4-10.2 mg/dl). Patients began treatment with cinacalcet in clinical practice. 32 patients with a mean age (standard deviation [SD]) of 54 (11) years, 56% male, were included in the study. Treatment with cinacalcet began a median of 16 months after RT (median dose of 30 mg/day). Levels of iPTH decreased from a median (P25, P75) of 364 (220, 531) pg/ml at the start of the study to 187 (98, 320) after 6 months (48.6% reduction, P=.001) and to 145 (91, 195) after 12 months (60.2% reduction, P=.001), without there being changes in calcium and phosphorus levels (P=.214 and P=.216, respectively). No changes were observed in kidney function or anti-calcineuric drug levels. 3.1% of patients discontinued cinacalcet due to intolerance and 6.2% due to a lack of efficacy. In patients with normocalcaemic SHPT after RT, cinacalcet improves the control of serum PTH values without causing changes to calcaemia, phosphataemia or kidney function. Cinacalcet showed good tolerability.

Multicentric Evaluation of New Commercial Enzyme Immunoassays for the Detection of Immunoglobulin M and Total Antibodies against Hepatitis A Virus▿

Science.gov (United States)

Arcangeletti, M. C.; Dussaix, E.; Ferraglia, F.; Roque-Afonso, A. M.; Graube, A.; Chezzi, C.

2011-01-01

A multicentric clinical study was conducted on representative sera from 1,738 European and U.S. subjects for the evaluation of new anti-hepatitis A virus enzyme immunoassays from Bio-Rad Laboratories. Comparison with reference DiaSorin S.p.A. tests confirmed the good performance of Bio-Rad assays (99.85% and 99.47% overall agreement in detecting total antibodies and IgM, respectively). PMID:21653739

Unified analytical treatment of multicentre electron attraction, electric field and electric field gradient integrals over Slater orbitals

International Nuclear Information System (INIS)

Guseinov, I I

2004-01-01

The new central and noncentral potential functions (CPFs and NCPFs) of a molecule depending on the coordinates of the nuclei are introduced. Using complete orthonormal sets of Ψ α -exponential-type orbitals (Ψ α -ETOs) introduced by the author, the series expansion formulae for the multicentre electronic attraction (EA), electric field (EF) and electric field gradient (EFG) integrals over Slater-type orbitals (STOs) in terms of CPFs and NCPFs are derived. The relationships obtained are valid for the arbitrary location, quantum numbers and screening constants of STOs

Pediatric supraglottic airway devices in clinical practice: A prospective observational study.

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Kleine-Brueggeney, Maren; Gottfried, Anne; Nabecker, Sabine; Greif, Robert; Book, Malte; Theiler, Lorenz

2017-09-02

Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™. This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmH 2 O ± 10%. None of the SGA showed a mean airway leak pressure of 20 cmH 2 O ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmH 2 O, Air-Q® 15.9 (3.2) cmH 2 O, Ambu® Aura-i™ 17.3 (3.7) cmH 2 O, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA Supreme™ 100%, Air-Q® 91%, Ambu® Aura-i™ 95%, p = 0.02) also differed significantly. Insertion times ranged from 20 (7) seconds (Air-Q®) to 24 (6) seconds (LMA Supreme™,

Radiation-induced emesis: a prospective observational multicenter Italian trial

International Nuclear Information System (INIS)

1999-01-01

Purpose: A prospective observational multicenter trial was carried out to assess the incidence, pattern, and prognostic factors of radiation-induced emesis (RIE), and evaluate the use of antiemetic drugs in radiation oncology clinical practice. Methods and Materials: Fifty-one Italian radiation oncology centers took part in this trial. The accrual lasted 2 consecutive weeks, only patients starting radiotherapy in this period were enrolled. Exclusion criteria were age under 18 years, and concomitant chemotherapy. Evaluation was based on diary cards filled in daily by patients during radiotherapy and 1 week after stopping it. Diary cards recorded the intensity of nausea and any episode of vomiting and retching. Prophylactic and symptomatic antiemetic drug prescriptions were also registered. Results: Nine hundred thirty-four patients entered the trial, and 914 were evaluable. Irradiated sites were: breast in 211 patients, pelvis in 210 patients, head and neck in 136 patients, thorax in 129 patients, brain in 52 patients, upper abdomen in 42 patients, skin and/or extremities in 37 patients, and other sites in 97 patients. Vomiting and nausea occurred in 17.1% and 37.3% of patients, respectively, and 38.7% patients had both vomiting and nausea. At multifactorial analysis, the only patient-related risk factor that was statistically significant was represented by previous experience with cancer chemotherapy. Moreover, two radiotherapy (RT)-related factors were significant risk factors for RIE, the irradiated site and field size. In fact, a statistically significant higher percentage of RIE was registered in upper abdomen RT and RT fields > 400 cm 2 . Although nonstatistically significant, patients receiving RT to the thorax and head and neck presented a higher incidence of RIE. Only a minority (14%) of patients receiving RT were given an antiemetic drug, and the prescriptions were more often symptomatic than prophylactic (9% vs. 5%, respectively). Different compounds and

Astrometric Observation of MACHO Gravitational Microlensing

Science.gov (United States)

Boden, A. F.; Shao, M.; Van Buren, D.

1997-01-01

This paper discusses the prospects for astrometric observation of MACHO gravitational microlensing events. We derive the expected astrometric observables for a simple microlensing event assuming a dark MACHO, and demonstrate that accurate astrometry can determine the lens mass, distance, and proper motion in a very general fashion.

Impact of regulatory spin of pioglitazone on prescription of antidiabetic drugs among physicians in India: A multicentre questionnaire-based observational study

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Aman Goyal

2017-01-01

Interpretation & conclusions: Majority of the physicians though were aware of the regulatory changes with regard to pioglitazone, but their prescribing patterns were not changed for this drug. However, it was being used at lower than the recommended dose. There is a need for generating more evidence through improved pharmacovigilance activities and large-scale population-based prospective studies regarding the safety issues of pioglitazone, so as to make effectual risk-benefit analysis for its continual use in T2DM.

Prospective evaluation of frequency of signs of systemic sclerosis in 76 patients with morphea.

Science.gov (United States)

Lipsker, Dan; Bessis, Didier; Cosnes, Anne; Kluger, Nicolas; Lutz, Virginie; Sauleau, Erik; Francès, Camille

2015-01-01

Some authors consider that morphoea and systemic sclerosis (SSc) could be part of the same disease spectrum. The aim of this study was to analyse the prevalence of signs indicative of SSc in a cohort of patients with morphoea. This is a prospective multi-centre study performed in four French academic dermatology departments: 76 patients with morphoea and 101 age- and sex-matched controls, who underwent complete clinical examination, were enrolled. A systemic search for signs indicative of SSc (e.g. Raynaud's phenomenon, reflux) was performed with the help of a standardised questionnaire. There were 58 women and 18 men (ration=3/1) with a median age of 59 years. Mean age at diagnosis was 54 years (extremes, 13-87). 49 subjects had plaque morphoea, 9 had generalised morphoea and 18 had linear morphoea. Mean duration of morphoea was 7.9 years. Signs possibly indicative of SSc were noted in four patients of the control group and in 8 patients with morphoea. This difference was not statistically significant (p=0.129). Further investigations ruled out SSc in all patients. Signs indicative of SSc are statistically not more frequently present in patients with morphoea than in controls and this study does not support the view that those 2 entities are part of a common disease spectrum.

A Prospective Profile of Visual Field Loss following Stroke: Prevalence, Type, Rehabilitation, and Outcome

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Fiona J. Rowe

2013-01-01

Full Text Available Aims. To profile site of stroke/cerebrovascular accident, type and extent of field loss, treatment options, and outcome. Methods. Prospective multicentre cohort trial. Standardised referral and investigation protocol of visual parameters. Results. 915 patients were recruited with a mean age of 69 years (SD 14. 479 patients (52% had visual field loss. 51 patients (10% had no visual symptoms. Almost half of symptomatic patients (n=226 complained only of visual field loss: almost half (n=226 also had reading difficulty, blurred vision, diplopia, and perceptual difficulties. 31% (n=151 had visual field loss as their only visual impairment: 69% (n=328 had low vision, eye movement deficits, or visual perceptual difficulties. Occipital and parietal lobe strokes most commonly caused visual field loss. Treatment options included visual search training, visual awareness, typoscopes, substitutive prisms, low vision aids, refraction, and occlusive patches. At followup 15 patients (7.5% had full recovery, 78 (39% had improvement, and 104 (52% had no recovery. Two patients (1% had further decline of visual field. Patients with visual field loss had lower quality of life scores than stroke patients without visual impairment. Conclusions. Stroke survivors with visual field loss require assessment to accurately define type and extent of loss, diagnose coexistent visual impairments, and offer targeted treatment.

Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

Science.gov (United States)

Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

2017-06-01

The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with

The impact of incident fractures on health-related quality of life: 5 years of data from the Canadian Multicentre Osteoporosis Study.

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Papaioannou, A; Kennedy, C C; Ioannidis, G; Sawka, A; Hopman, W M; Pickard, L; Brown, J P; Josse, R G; Kaiser, S; Anastassiades, T; Goltzman, D; Papadimitropoulos, M; Tenenhouse, A; Prior, J C; Olszynski, W P; Adachi, J D

2009-05-01

Using prospective data from the Canadian Multicentre Osteoporosis Study (CaMos), we compared health utilities index (HUI) scores after 5 years of follow-up among participants (50 years and older) with and without incident clinical fractures. Incident fractures had a negative impact on HUI scores over time. This study examined change in health-related quality of life (HRQL) in those with and without incident clinical fractures as measured by the HUI. The study cohort was 4,820 women and 1,783 men (50 years and older) from the CaMos. The HUI was administered at baseline and year 5. Participants were sub-divided into incident fracture groups (hip, rib, spine, forearm, pelvis, other) and were compared with those without these fractures. The effects of both time and fracture type on HUI scores were examined in multivariable regression analyses. Men and women with hip fractures, compared to those without, had lower HUI measures that ranged from -0.05 to -0.25. Both women and men with spine fractures had significant deficits on the pain attributes (-0.07 to -0.12). In women, self-care (-0.06), mobility and ambulation (-0.05) were also negatively impacted. Women with rib fractures had deficits similar to women with spine fractures, and these effects persisted over time. In men, rib fractures did not significantly affect HUI scores. Pelvic and forearm fractures did not substantially influence HUI scores. The HUI was a sensitive measure of HRQL change over time. These results will inform economic analyses evaluating osteoporosis therapies.

Characterisation of a plastic scintillation detector to be used in a multicentre stereotactic radiosurgery dosimetry audit

Science.gov (United States)

Dimitriadis, A.; Patallo, I. Silvestre; Billas, I.; Duane, S.; Nisbet, A.; Clark, C. H.

2017-11-01

Scintillation detectors are considered highly suitable for dosimetric measurement of small fields in radiotherapy due to their near-tissue equivalence and their small size. A commercially available scintillation detector, the Exradin W1 (Standard Imaging, Middleton, USA), has been previously characterised by two independent studies (Beierholm et al., 2014; Carrasco et al., 2015a, 2015b) but the results from these publications differed in some aspects (e.g. energy dependence, long term stability). The respective authors highlighted the need for more studies to be published (Beierholm et al., 2015; Carrasco et al., 2015a, 2015b). In this work, the Exradin W1 was characterised in terms of dose response, dependence on dose rate, energy, temperature and angle of irradiation, and long-term stability. The observed dose linearity, short-term repeatability and temperature dependence were in good agreement with previously published data. Appropriate corrections should therefore be applied, where possible, in order to achieve measurements with low-uncertainty. The angular dependence was characterised along both the symmetrical and polar axis of the detector for the first time in this work and a dose variation of up to 1% was observed. The response of the detector was observed to decrease at a rate of approximately 1.6% kGy-1 for the first 5 kGy delivered, and then stabilised to 0.2% kGy-1 in the subsequent 20 kGy. The main goal of this work was to assess the suitability of the Exradin W1 for use in dose verification measurements for stereotactic radiosurgery. The results obtained confirm that the detector is suitable for use in such situations. The detector is now utilised in a multi-centre stereotactic radiosurgery dosimetric audit, with the application of appropriate correction factors.

Prophylactic efficacy of lithium administered every second day: a WHO multicentre study

DEFF Research Database (Denmark)

Plenge, P; Amin, M; Agarwal, A K

1999-01-01

OBJECTIVES: To study the prophylactic efficacy of lithium administered every second day to patients with bipolar disorder or recurrent unipolar depressive disorder. METHODS: The study was carried out as a WHO multicentre study in five different psychiatric clinics: Russia (Moscow), Canada (Montreal......), India (Lucknow), Germany (Munich) and South Korea (Pusan), with the lithium tablets being supplied from Denmark (Copenhagen). Participation in the study was conditional on the patient having been in prophylactic lithium treatment for the preceding 2-year period and having been free of depressive...... of bipolar disorder and five with a diagnosis of recurrent unipolar depressive disorder, participated in the study. The number of patients from each centre ranged from six to 11. The mean lithium dose every second day was 36 mmol lithium, leading to a mean 12-h standard serum lithium concentration during...

A Prospective Observational Study of Technical Difficulty With GlideScope-Guided Tracheal Intubation in Children.

Science.gov (United States)

Zhang, Bin; Gurnaney, Harshad G; Stricker, Paul A; Galvez, Jorge A; Isserman, Rebecca S; Fiadjoe, John E

2018-05-09

The GlideScope Cobalt is one of the most commonly used videolaryngoscopes in pediatric anesthesia. Although visualization of the airway may be superior to direct laryngoscopy, users need to learn a new indirect way to insert the tracheal tube. Learning this indirect approach requires focused practice and instruction. Identifying the specific points during tube placement, during which clinicians struggle, would help with targeted education. We conducted this prospective observational study to determine the incidence and location of technical difficulties using the GlideScope, the success rates of various corrective maneuvers used, and the impact of technical difficulty on success rate. We conducted this observational study at our quaternary pediatric hospital between February 2014 and August 2014. We observed 200 GlideScope-guided intubations and documented key intubation-related outcomes. Inclusion criteria for patients were the number of advancement maneuvers required to intubate the trachea, the location where technical difficulty occurred, the types of maneuvers used to address difficulties, and the tracheal intubation success rate. We used a bias-corrected bootstrapping method with 300 replicates to determine the 95% confidence interval (CI) around the rate of difficulty with an intubation attempt. After excluding attempts by inexperienced clinicians, there were 225 attempts in 187 patients, 58% (131 of 225; bootstrap CI, 51.6%-64.6%]) of the attempts had technical difficulties. Technical difficulty was most likely to occur when inserting the tracheal tube between the plane of the arytenoid cartilages to just beyond the vocal cords: "zone 3." Clockwise rotation of the tube was the most common successful corrective maneuver in zone 3. The overall tracheal intubation success rate was 98% (CI, 95%-99%); however, the first attempt success rate was only 80% (CI, 74%-86%). Patients with technical difficulty had more attempts (median [interquartile range], 2 [1

Treatment of unstable trochanteric fractures. Randomised comparison of the gamma nail and the proximal femoral nail.

NARCIS (Netherlands)

Schipper, I.B.; Steyerberg, E.W.; Castelein, R.M.; Heijden, F.H. van der; Hoed, P.T. den; Kerver, A.J.; Vugt, A.B. van

2004-01-01

The proximal femoral nail (PFN) is a recently introduced intramedullary system, designed to improve treatment of unstable trochanteric fractures of the hip. In a multicentre prospective clinical study, the intra-operative use, complications and outcome of treatment using the PFN (n = 211) were

Correlation of shoulder range of motion limitations at discharge with limitations in activities and participation one year later in persons with spinal cord injury

NARCIS (Netherlands)

Eriks-Hoogland, Inge E.; de Groot, Sonja; Post, Marcel W. M.; van der Woude, Lucas H. V.

Objective: To study the correlation between limited shoulder range of motion in persons with spinal cord injury at discharge and the performance of activities, wheeling performance, transfers and participation one year later. Design: Multicentre prospective cohort study. Subjects: A total of 146

Conservative treatment of a mandibular condyle fracture: comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

NARCIS (Netherlands)

van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

2015-01-01

Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

NARCIS (Netherlands)

van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

2015-01-01

Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

Cost-effectiveness and quality-of-life assessment of GM-CSF as an adjunct to intensive remission induction chemotherapy in elderly patients with acute myeloid leukaemia

NARCIS (Netherlands)

Uyl-de Groot, CA; Lowenberg, B; Vellenga, E; Suciu, S; Willemze, R; Rutten, FFH

We conducted a prospective, randomized, multicentre clinical trial comparing the effects and costs of GM-CSF as an adjunct to intensive chemotherapy in elderly patients with acute myeloid leukaemia (AML). The patients were randomized to either daunomycin-cytosine arabinoside (control arm: rr = 161)

Predicting worsening asthma control following the common cold

NARCIS (Netherlands)

Walter, M. J.; Castro, M.; Kunselman, S. J.; Chinchilli, V. M.; Reno, M.; Ramkumar, T. P.; Avila, P. C.; Boushey, H. A.; Ameredes, B. T.; Bleecker, E. R.; Calhoun, W. J.; Cherniack, R. M.; Craig, T. J.; Denlinger, L. C.; Israel, E.; Fahy, J. V.; Jarjour, N. N.; Kraft, M.; Lazarus, S. C.; Lemanske, R. F.; Martin, R. J.; Peters, S. P.; Ramsdell, J. W.; Sorkness, C. A.; Sutherland, E. R.; Szefler, S. J.; Wasserman, S. I.; Wechsler, M. E.

2008-01-01

The asthmatic response to the common cold is highly variable, and early characteristics that predict worsening of asthma control following a cold have not been identified. In this prospective multicentric cohort study of 413 adult subjects with asthma, the mini-Asthma Control Questionnaire

Preterm birth in singleton and multiple pregnancies : evaluation of costs and perinatal outcomes

NARCIS (Netherlands)

van Baaren, Gert J.; Peelen, Myrthe J. C. S.; Schuit, Ewoud; van der Post, Joris A. M.; Mol, Ben W. J.; Kok, Marjolein; Hajenius, Petra J.

Objective: To estimate costs of preterm birth in singleton and multiple pregnancies. Study design: Cost analysis based on data from a prospective cohort study and three multicentre randomised controlled trials (2006-2012) in a Dutch nationwide consortium for women's health research. Women with

Epidural spinal cord stimulation for neuropathic pain: a neurosurgical multicentric Italian data collection and analysis.

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Colombo, Elena Virginia; Mandelli, Carlo; Mortini, Pietro; Messina, Giuseppe; De Marco, Nicola; Donati, Roberto; Irace, Claudio; Landi, Andrea; Lavano, Angelo; Mearini, Massimo; Podetta, Stefano; Servello, Domenico; Zekaj, Edvin; Valtulina, Carlo; Dones, Ivano

2015-04-01

Spinal cord stimulation (SCS) is a technique used worldwide to treat several types of chronic neuropathic pain refractory to any conservative treatment. The aim of this data collection is to enforce evidence of SCS effectiveness on neuropathic chronic pain reported in the literature and to speculate on the usefulness of the trial period in determining the long-term efficacy. Moreover, the very low percentage of undesired side effects and complications reported in our case series suggests that all implants should be performed by similarly well-trained and experienced professionals. A multicentric data collection on a common database from 11 Italian neurosurgical departments started 3 years ago. Two different types of electrodes (paddle or percutaneous leads) were used. Of 122 patients, 73 % (N = 89) were submitted to a trial period, while the remaining patients underwent the immediate permanent implant (N = 33). Statistical comparisons of continuous variables between groups were performed. Most of the patients (80 %) had predominant pain to their lower limbs, while only 17 % of patients had prevalent axial pain. Significant reduction in pain, as measured by variation in visual analogue scale (VAS) score, was observed at least 1 year after implantation in 63.8 % of the cases, 59.5 % of patients who underwent a test trial and 71.4 % of patients who underwent permanent implant at once. No statistical differences were found between the lower-limb pain group and the axial pain group. No relevant differences in long-term outcomes were observed in previously tested patients compared with patients implanted at once. Through this analysis we hope to recruit new centres, to give more scientific value to our results.

Connect MDS/AML: design of the myelodysplastic syndromes and acute myeloid leukemia disease registry, a prospective observational cohort study.

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Steensma, David P; Abedi, Medrdad; Bejar, Rafael; Cogle, Christopher R; Foucar, Kathryn; Garcia-Manero, Guillermo; George, Tracy I; Grinblatt, David; Komrokji, Rami; Ma, Xiaomei; Maciejewski, Jaroslaw; Pollyea, Daniel A; Savona, Michael R; Scott, Bart; Sekeres, Mikkael A; Thompson, Michael A; Swern, Arlene S; Nifenecker, Melissa; Sugrue, Mary M; Erba, Harry

2016-08-19

Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are myeloid neoplasms in which outgrowth of neoplastic clones disrupts normal hematopoiesis. Some patients with unexplained persistent cytopenias may not meet minimal diagnostic criteria for MDS but an alternate diagnosis is not apparent; the term idiopathic cytopenia of undetermined significance (ICUS) has been used to describe this state. MDS and AML occur primarily in older patients who are often treated outside the clinical trial setting. Consequently, our understanding of the patterns of diagnostic evaluation, management, and outcomes of these patients is limited. Furthermore, there are few natural history studies of ICUS. To better understand how patients who have MDS, ICUS, or AML are managed in the routine clinical setting, the Connect MDS/AML Disease Registry, a multicenter, prospective, observational cohort study of patients newly diagnosed with these conditions has been initiated. The Connect MDS/AML Disease Registry will capture diagnosis, risk assessment, treatment, and outcomes data for approximately 1500 newly diagnosed patients from approximately 150 community and academic sites in the United States in 4 cohorts: (1) lower-risk MDS (International Prognostic Scoring System [IPSS] low and intermediate-1 risk), with and without del(5q); (2) higher-risk MDS (IPSS intermediate-2 and high risk); (3) ICUS; and (4) AML in patients aged ≥ 55 years (excluding acute promyelocytic leukemia). Diagnosis will be confirmed by central review. Baseline patient characteristics, diagnostic patterns, treatment patterns, clinical outcomes, health economics outcomes, and patient-reported health-related quality of life will be entered into an electronic data capture system at enrollment and quarterly for 8 years. A tissue substudy to explore the relationship between karyotypes, molecular markers, and clinical outcomes will be conducted, and is optional for patients. The Connect MDS/AML Disease

Danazol treatment of benign breast disease: a survey of U.S.A. multi-centre studies.

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Brookshaw, J D

1979-01-01

514 patients with benign breast disease provided records from multicentre studies in the U.S.A. Results showed that a high proportion responded with either decrease or elimination of symptoms, response usually being apparent 15 to 45 days after commencing treatment. Dosage schedules varied between 50 and 400 mg danazol daily and length of treatment between 15 and 196 days. There was a tendency for patients with more severe symptoms to respond better to the higher dosages, and for the elimination rate for all grades of severity to improve with time. Side effects were not severe, and of the expected type including weight gain, oiliness of skin and hair, and acne.

Possible Association of Multicentric Castleman's Disease with Autoimmune Lymphoproliferative Syndrome

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Hiroyuki Minemura

2018-04-01

Full Text Available Multicentric Castleman's disease (MCD is lymphoproliferative disorder characterized by systemic inflammatory symptoms such as fever and weight loss. Human herpes virus-8 (HHV-8 is thought to be a causable pathogen in all HIV-positive and some HIV-negative MCD patients. Furthermore, the term idiopathic MCD (iMCD was recently proposed to represent a group of HIV-negative and HHV-8-negative patients with unknown etiologies. Although the international diagnostic criteria for iMCD require exclusion of infection-related disorders, autoimmune/autoinflammatory diseases and malignant/lymphoproliferative disorders to make an iMCD diagnosis, the relationships and differences between these disorders and MCD have not yet been clarified. We recently reported the first case of MCD with autoimmune lymphoproliferative syndrome (ALPS. Although ALPS was included in the iMCD exclusion criteria as an autoimmune/autoinflammatory disease according to the international diagnostic criteria, there is a lack of evidence on the association between MCD and ALPS. In this study, we review the recent understanding of MCD and discuss the possible association between MCD with ALPS.

Moral imperialism and multi-centric clinical trials in peripheral countries.

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Garrafa, Volnei; Lorenzo, Claudio

2008-10-01

Moral imperialism is expressed in attempts to impose moral standards from one particular culture, geopolitical region or culture onto other cultures, regions or countries. Examples of Direct Moral Imperialism can be seen in various recurrent events involving multi-centric clinical trials promoted by developed (central) countries in poor and developing (peripheral) countries, particularly projects related to the theory of double standards in research. After the WMA General Assembly refused to change the Helsinki Declaration - which would have given moral recognition to the above mentioned theory - the USA abandoned the declaration and began to promote regional seminars in peripheral countries with the aim of "training" researchers on ethical perspectives that reflect America's best interests. Individuals who received such training became transmitters of these central countries' ideas across the peripheral countries, representing a form of Indirect Moral Imperialism. The paper proposes the establishment of regulatory and social control systems for clinical trials implemented in peripheral countries, through the formulation of ethical norms that reflect the specific contexts of these countries, along with the drawing up and validation of their own national norms.

The Predictive Value of Integrated Pulmonary Index after Off-Pump Coronary Artery Bypass Grafting: A Prospective Observational Study

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Evgenia V. Fot

2017-08-01

Full Text Available BackgroundThe early warning scores may increase the safety of perioperative period. The objective of this study was to assess the diagnostic and predictive role of Integrated Pulmonary Index (IPI after off-pump coronary artery bypass grafting (OPCAB.Materials and MethodsForty adult patients undergoing elective OPCAB were enrolled into a single-center prospective observational study. We assessed respiratory function using IPI that includes oxygen saturation, end-tidal CO2, respiratory rate, and pulse rate. In addition, we evaluated blood gas analyses and hemodynamics, including ECG, invasive arterial pressure, and cardiac index. The measurements were performed after transfer to the intensive care unit, after spontaneous breathing trial and at 2, 6, 12, and 18 h after extubation.Results and DiscussionThe value of IPI registered during respiratory support correlated weakly with cardiac index (rho = 0.4; p = 0.04 and ScvO2 (rho = 0.4, p = 0.02. After extubation, IPI values decreased significantly, achieving a minimum by 18 h. The IPI value ≤9 at 6 h after extubation was a predictor of complicated early postoperative period (AUC = 0.71; p = 0.04 observed in 13 patients.ConclusionIn off-pump coronary surgery, the IPI decreases significantly after tracheal extubation and may predict postoperative complications.

Response of Treatment in Patients with Primary Headaches and Hypertension: A Prospective Observational Pilot Study

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Abdullah Cüneyt Hocagil

2018-03-01

Full Text Available Objective: To determine the priority in the treatment of patients with primary headaches accompanied by high blood pressure. In our study, we investigated whether there was a relationship between the decline in headache after treatment and the change in the average arterial pressure. Materials and Methods: This prospective observational study was performed with 101 patients who were admitted to the hospital emergency department with primary headache accompanied by high blood pressure. After treatment, the decrease in the severity of headaches, mean arterial pressure, and percentage value for the drop of mean arterial pressure were calculated for all patients. Results: In the study, 25 (24.8% patients’ headache decreased 3 levels, 43 (42.6% patients’ headache decreased 2 levels, and 23 (22.8% patients’ headache decreased one level. The mean arterial pressure value at admission was 118.58±12.65 mmHg, and after treatment at the 30th minute decreased to 98.41±13.43 mmHg. Although there was a statistically significant (p0.05 drop in the mean arterial pressure value of the patients with one level decrease in headache severity after treatment. Conclusion: This study showed that when a primary headache, which is often associated with high blood pressure, was treated instead of treating high blood pressure as a secondary cause of headache, blood pressure decreased spontaneously

Diversity of dietary patterns observed in the European Prospective Investigation into Cancer and Nutrition (EPIC) project

NARCIS (Netherlands)

Slimani, N.; Fahey, M.; Welch, A.A.; Wirfalt, E.; Stripp, C.; Bergstrom, E.; Linseisen, J.; Schulze, M.B.; Bamia, C.; Chloptsios, Y.; Veglia, F.; Panico, S.; Bueno de Mesquita, B.; Ocké, M.C.; Brustadt, M.; Lund, E.; Gonzalez, C.A.; Barcos, A.; Berglund, G.; Winkvist, A.; Mulligan, A.; Appleby, P.; Overvad, K.; Tjonneland, A.; Clavel-Chapelon, F.; Kesse, E.; Ferrari, P.; Staveren, van W.A.; Riboli, E.

2002-01-01

Objective: To describe the diversity in dietary patterns existing across centres/regions participating in the European Prospective Investigation into Cancer and Nutrition (EPIC). Design and setting: Single 24-hour dietary recall measurements were obtained by means of standardised face-to-face

Azathioprine-induced Acute Pancreatitis in Patients with Inflammatory Bowel Diseases—A Prospective Study on Incidence and Severity

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Mohl, Wolfgang; Bokemeyer, Bernd; Bündgens, Burkhard; Büning, Jürgen; Miehlke, Stephan; Hüppe, Dietrich; Maaser, Christian; Klugmann, Tobias; Kruis, Wolfgang; Siegmund, Britta; Helwig, Ulf; Weismüller, Joseph; Drabik, Attyla; Stallmach, Andreas

2016-01-01

Background and Aims: Azathioprine [AZA] is recommended for maintenance of steroid-free remission in inflammatory bowel disease IBD. The aim of this study has been to establish the incidence and severity of AZA-induced pancreatitis, an idiosyncratic and major side effect, and to identify specific risk factors. Methods: We studied 510 IBD patients [338 Crohn’s disease, 157 ulcerative colitis, 15 indeterminate colitis] with initiation of AZA treatment in a prospective multicentre registry study. Acute pancreatitis was diagnosed in accordance with international guidelines. Results: AZA was continued by 324 [63.5%] and stopped by 186 [36.5%] patients. The most common cause of discontinuation was nausea [12.2%]. AZA-induced pancreatitis occurred in 37 patients [7.3%]. Of these: 43% were hospitalised with a median inpatient time period of 5 days; 10% had peripancreatic fluid collections; 24% had vomiting; and 14% had fever. No patient had to undergo nonsurgical or surgical interventions. Smoking was the strongest risk factor for AZA-induced acute pancreatitis [p pancreatitis is a common adverse event in IBD patients, but in this study had a mild course in all patients. Smoking is the most important risk factor. PMID:26468141

Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case-control study in the U.K.

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Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

2014-06-01

Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the U.K. in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. A prospective multicentre case-control study was conducted at six U.K. hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Daily pilates exercise or inactivity for patients with low back pain: a clinical prospective observational study.

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Notarnicola, A; Fischetti, F; Maccagnano, G; Comes, R; Tafuri, S; Moretti, B

2014-02-01

Studies have shown the effectiveness of a few weekly pilates sessions as helping to reduce lower back pain (LBP). However many patients fear that physical activity can actually make the pain and disability worse. We carried out this observational prospective clinical study to look at the effects that taking part in daily pilates has one on side and on the other the effects of LBP management without physical exercise. The volunteers who participated in this study were recruited from among some local cultural associations. Patients affected by LBP were evaluated. The subjects were 60 volunteers (27 males and 33 females) with a mean age of 51.2 years who had chronic low back pain (CLBP). They were allocated to pilates group (N.=30) or inactivity control group (N.=30). The pilates group performed one-hour lesson of pilates exercise, 5 lessons per week during the following 6 months. The inactivity group continued with their normal daily activities. The Roland-Morris Disability, the Oswestry, the SF-36 and the Spinal Functional Sort Questionaries of all subjects were measured at the baseline (T1) and at 6 months (T2). At T2 improvements were observed in the pilates group with increases in physical and social functioning, general health and vitality (Ppilates. Some authors underlined the possible risk of a lack of adherence to an exercise program at home. This study suggests that a daily pilates program is effective for the management of CLBP. On the other hand, the inactivity contributes to further worsening, inducing a vicious cycle in which pain and physical activity intolerance follow each other.

The Home Observation of Periconceptional Exposures (HOPE) study, a prospective cohort: aims, design, recruitment and compliance.

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Porucznik, Christina A; Cox, Kyley J; Schliep, Karen C; Wilkins, Diana G; Stanford, Joseph B

2016-06-08

To examine transient environmental exposures and their relationship with human fecundity, exposure assessment should occur optimally at the time of conception in both members of the couple. We performed an observational, prospective cohort study with biomonitoring in both members of a heterosexual couple trying to conceive. Couples collected urine, saliva, and semen specimens for up to two menstrual cycles on days corresponding to the time windows of fertilization, implantation, and early pregnancy, identified based on the woman's observations of her cervical fluid. Three hundred nine eligible couples were screened between 2011 and 2015, of which 183 enrolled. Eleven couples (6.0 %) withdrew or were lost to follow up. The most successful and cost effective recruiting strategies were word of mouth (40 % of participating couples), posters and flyers (37 %), and targeted Facebook advertising (13 %) with an overall investment of $37.35 spent on recruitment per couple. Both men and women collected ≥97.2 % of requested saliva samples, and men collected ≥89.9 % of requested semen samples. Within the periovulatory days (±3 days), there was at least one urine specimen collected by women in 97.1 % of cycles, and at least one by men in 91.7 % of cycles. Daily compliance with periovulatory urine specimens ranged from 66.5 to 92.4 % for women and from 55.7 to 75.0 % for men. Compliance was ≥88 % for questionnaire completion at specified time points. Couples planning to conceive can be recruited successfully for periconceptional monitoring, and will comply with intensive study protocols involving home collection of biospecimens and questionnaire data.

Risk factors for post-colorectal endoscopic submucosal dissection (ESD) coagulation syndrome: a multicenter, prospective, observational study

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Arimoto, Jun; Higurashi, Takuma; Kato, Shingo; Fuyuki, Akiko; Ohkubo, Hidenori; Nonaka, Takashi; Yamaguchi, Yoshikazu; Ashikari, Keiichi; Chiba, Hideyuki; Goto, Shungo; Taguri, Masataka; Sakaguchi, Takashi; Atsukawa, Kazuhiro; Nakajima, Atsushi

2018-01-01

Background and study aims  Colorectal cancer (CRC) is one of the most common neoplasms and endoscopic submucosal dissection (ESD) is an effective treatment for early-stage CRC. However, it has been observed that patients undergoing ESD often complain of pain, even if ESD has been successfully performed. Risk factors for such pain still remain unknown. The aim of this study was to explore the risk factors for post-colorectal ESD coagulation syndrome (PECS). Patients and methods  This was a prospective multicenter observational trial (UMIN000016781) conducted in 106 of 223 patients who underwent ESD between March 2015 and April 2016. We investigated age, sex, tumor location, ESD operation time, lesion size, duration of hospitalization, and frequency of PECS. We defined PECS as local abdominal pain (evaluated on a visual analogue scale) in the region corresponding to the site of the ESD that occurred within 4 days of the procedure. Results  PECS occurred in 15/106 (14.2 %), and 10 were women ( P  = 0.01, OR: 7.74 [1.6 – 36.4]), 7 had lesions in the cecum ( P   90 min ( P  = 0.002, OR: 10.3 [2.4 – 44.6]). Frequency of deviation from the prescribed clinical path was significantly higher (47 % [7/15] vs. 2 % [2/91], P  PECS group.  Conclusions  Female gender, location of lesion in the cecum, and ESD operation time > 90 minutes were significant risk factors independent of PECS. These findings are important to management of PECS.  PMID:29527556

Distress in suspected lung cancer patients following rapid and standard diagnostic programs: a prospective observational study.

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Brocken, Pepijn; van der Heijden, Erik H F M; Oud, Karen T M; Bootsma, Gerben; Groen, Harry J M; Donders, A Rogier T; Dekhuijzen, P N Richard; Prins, Judith B

2015-04-01

Timeliness may influence emotional distress during the diagnostic phase of suspected lung cancer patients. We performed a prospective observational study to compare distress and quality of life (QoL) in two medical centres with a Rapid Outpatient Diagnostic Program (RODP) and two using conventional Stepwise Diagnostic Approach (SDA) on the basis of trained nurse-led care. Outpatients with radiological suspicion of lung cancer completed the Hospital Anxiety and Depression Scale (HADS), European Organization for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (QLQ-C30) and its 13-item Lung Cancer specific module (QLQ-LC13) upon first visit, 2 days later, thereafter weekly for 5 weeks and after 3 months. The 72 SDA patients and 121 RODP patients had a mean pre-diagnostic HADS-total score of 13.5 (SD 7.6); 63.4% had a score ≥10. Baseline QLQ-C30 global QoL was 61.6 (SD 22.7) exceeding reference values for lung cancer patients. Generalized least square models showed a significant centre by time interaction effect: during the first 6 weeks, HADS-total scores decreased in RODP patients (13.8-11.9) but sustained in SDA patients (13.1-13.6), whereas QoL showed no relevant changes. Times to diagnosis and discussion of therapy plan for RODP patients were 7 and 11 days shorter, respectively. Suspected lung cancer patients had high baseline distress levels. A decrease over time was found in RODP compared with SDA patients. QoL did not change relevantly. Albeit observational, these data indicate that patients experience less distress in rapid diagnostic programs than in stepwise diagnostic evaluation. Copyright © 2014 John Wiley & Sons, Ltd.

EnROL: A multicentre randomised trial of conventional versus laparoscopic surgery for colorectal cancer within an enhanced recovery programme

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Kennedy Robin H

2012-05-01

Full Text Available Abstract Background During the last two decades the use of laparoscopic resection and a multimodal approach known as an enhanced recovery programme, have been major changes in colorectal perioperative care. Clinical outcome improves using laparoscopic surgery to resect colorectal cancer but until recently no multicentre trial evidence had been reported regarding whether the benefits of laparoscopy still exist when open surgery is optimized within an enhanced recovery programme. The EnROL trial (Enhanced Recovery Open versus Laparoscopic examines the hypothesis that laparoscopic surgery within an enhanced recovery programme will provide superior postoperative outcomes when compared to conventional open resection of colorectal cancer within the same programme. Methods/design EnROL is a phase III, multicentre, randomised trial of laparoscopic versus open resection of colon and rectal cancer with blinding of patients and outcome observers to the treatment allocation for the first 7 days post-operatively, or until discharge if earlier. 202 patients will be recruited at approximately 12 UK hospitals and randomised using minimization at a central computer system in a 1:1 ratio. Recruiting surgeons will previously have performed >100 laparoscopic colorectal resections and >50 open total mesorectal excisions to minimize conversion. Eligible patients are those suitable for elective resection using either technique. Excluded patients include: those with acute intestinal obstruction and patients in whom conversion from laparoscopic to open procedure is likely. The primary outcome is physical fatigue as measured by the physical fatigue domain of the multidimensional fatigue inventory 20 (MFI-20 with secondary outcomes including postoperative hospital stay; complications; reoperation and readmission; quality of life indicators; cosmetic assessments; standardized performance indicators; health economic analysis; the other four domains of the MFI-20