Study Protocol. IDUS – Instrumental delivery & ultrasound. A multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery

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Murphy Deirdre J

2012-09-01

Full Text Available Abstract Background Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 – 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice. Methods/Design A multi-centre randomised controlled trial is proposed. The study will take place in two large maternity units in Ireland with a combined annual birth rate of 13,500 deliveries. It will involve 450 nulliparous women undergoing instrumental delivery after 37 weeks gestation. The main outcome measure will be incorrect diagnosis of the fetal head position. A study involving 450 women will have 80% power to detect a 10% difference in the incidence of inaccurate diagnosis of the fetal head position with two-sided 5% alpha. Discussion It is both important and timely to evaluate the use of ultrasound to diagnose the fetal head position prior to instrumental delivery before routine use can be advocated. The overall aim is to reduce the incidence of incorrect diagnosis of the fetal head position prior to instrumental delivery and improve the safety of instrumental deliveries. Trial registration Current Controlled Trials ISRCTN72230496

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...

Insoluble drug delivery strategies: review of recent advances and business prospects

Science.gov (United States)

Kalepu, Sandeep; Nekkanti, Vijaykumar

2015-01-01

The emerging trends in the combinatorial chemistry and drug design have led to the development of drug candidates with greater lipophilicity, high molecular weight and poor water solubility. Majority of the failures in new drug development have been attributed to poor water solubility of the drug. Issues associated with poor solubility can lead to low bioavailability resulting in suboptimal drug delivery. About 40% of drugs with market approval and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. With the advent of various insoluble drug delivery technologies, the challenge to formulate poorly water soluble drugs could be achieved. Numerous drugs associated with poor solubility and low bioavailabilities have been formulated into successful drug products. Several marketed drugs were reformulated to improve efficacy, safety and patient compliance. In order to gain marketing exclusivity and patent protection for such products, revitalization of poorly soluble drugs using insoluble drug delivery technologies have been successfully adopted by many pharmaceutical companies. This review covers the recent advances in the field of insoluble drug delivery and business prospects. PMID:26579474

Insoluble drug delivery strategies: review of recent advances and business prospects

Directory of Open Access Journals (Sweden)

Sandeep Kalepu

2015-09-01

Full Text Available The emerging trends in the combinatorial chemistry and drug design have led to the development of drug candidates with greater lipophilicity, high molecular weight and poor water solubility. Majority of the failures in new drug development have been attributed to poor water solubility of the drug. Issues associated with poor solubility can lead to low bioavailability resulting in suboptimal drug delivery. About 40% of drugs with market approval and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. With the advent of various insoluble drug delivery technologies, the challenge to formulate poorly water soluble drugs could be achieved. Numerous drugs associated with poor solubility and low bioavailabilities have been formulated into successful drug products. Several marketed drugs were reformulated to improve efficacy, safety and patient compliance. In order to gain marketing exclusivity and patent protection for such products, revitalization of poorly soluble drugs using insoluble drug delivery technologies have been successfully adopted by many pharmaceutical companies. This review covers the recent advances in the field of insoluble drug delivery and business prospects.

SU-C-BRD-01: Multi-Centre Collaborative Quality Assurance Program for IMRT Planning and Delivery: Year 3 Results

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McNiven, A; Jaffray, D; Letourneau, D [Princess Margaret Cancer Centre and Department of Radiation Oncology, University of Toronto, Toronto, ON (Canada)

2015-06-15

Purpose: A multi-centre quality assurance program was developed to enable quality improvement by coupling measurement of intensity modulated radiotherapy (IMRT) planning and delivery performance for site-specific planning exercises with diagnostic testing. The third year of the program specifically assessed the quality of spine stereotactic body radiotherapy (SBRT) planning and delivery amongst the participating centres. Methods: A spine SBRT planning exercise (24 Gy in 2 fractions) was created and completed by participants prior to an on-site visit. The delivery portion of the on-site visit included spine SBRT plan delivery and diagnostic testing, which included portal image acquisition for quantification of phantom positioning error and multi-leaf collimator (MLC) calibration accuracy. The measured dose was compared to that calculated in the treatment planning system (TPS) using 3%/2mm composite analysis and 3%/3mm gamma analysis. Results: Fourteen institutions participated, creating 17 spine SBRT plans (15 VMAT and 2 IMRT). Three different TPS, two beam energies (6 MV and 6 MV FFF), and four MLC designs from two linac vendors were tested. Large variation in total monitor units (MU) per plan (2494–6462 MU) and dose-volume parameters was observed. The maximum point dose in the plans ranged from 116–149% and was dependent upon the TPS used. Pass rates for measured to planned dose comparison ranged from 89.4–100% and 97.3–100% for 3%/2mm and 3%/3mm criteria respectively. The largest measured MLC error did Result in one of the poorer pass rates. No direct correlation between phantom positioning error and pass rates overall. Conclusion: Significant differences were observed in the planning exercise for some plan and dose-volume parameters based on the TPS used. Standard evaluation criteria showed good agreement between planned and measured dose for all participants, however on an individual plan basis, diagnostic tests were able to identify contributing

SU-C-BRD-01: Multi-Centre Collaborative Quality Assurance Program for IMRT Planning and Delivery: Year 3 Results

International Nuclear Information System (INIS)

McNiven, A; Jaffray, D; Letourneau, D

2015-01-01

Purpose: A multi-centre quality assurance program was developed to enable quality improvement by coupling measurement of intensity modulated radiotherapy (IMRT) planning and delivery performance for site-specific planning exercises with diagnostic testing. The third year of the program specifically assessed the quality of spine stereotactic body radiotherapy (SBRT) planning and delivery amongst the participating centres. Methods: A spine SBRT planning exercise (24 Gy in 2 fractions) was created and completed by participants prior to an on-site visit. The delivery portion of the on-site visit included spine SBRT plan delivery and diagnostic testing, which included portal image acquisition for quantification of phantom positioning error and multi-leaf collimator (MLC) calibration accuracy. The measured dose was compared to that calculated in the treatment planning system (TPS) using 3%/2mm composite analysis and 3%/3mm gamma analysis. Results: Fourteen institutions participated, creating 17 spine SBRT plans (15 VMAT and 2 IMRT). Three different TPS, two beam energies (6 MV and 6 MV FFF), and four MLC designs from two linac vendors were tested. Large variation in total monitor units (MU) per plan (2494–6462 MU) and dose-volume parameters was observed. The maximum point dose in the plans ranged from 116–149% and was dependent upon the TPS used. Pass rates for measured to planned dose comparison ranged from 89.4–100% and 97.3–100% for 3%/2mm and 3%/3mm criteria respectively. The largest measured MLC error did Result in one of the poorer pass rates. No direct correlation between phantom positioning error and pass rates overall. Conclusion: Significant differences were observed in the planning exercise for some plan and dose-volume parameters based on the TPS used. Standard evaluation criteria showed good agreement between planned and measured dose for all participants, however on an individual plan basis, diagnostic tests were able to identify contributing

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

Effects of Cesarean Delivery on Breastfeeding Practices and Duration: A Prospective Cohort Study.

Science.gov (United States)

Chen, Cheng; Yan, Yan; Gao, Xiao; Xiang, Shiting; He, Qiong; Zeng, Guangyu; Liu, Shiping; Sha, Tingting; Li, Ling

2018-01-01

Mothers are encouraged to exclusively breastfeed for the first 6 months. However, cesarean delivery rates have increased worldwide, which may affect breastfeeding. Research aim: This study aimed to determine the potential effects of cesarean delivery on breastfeeding practices and breastfeeding duration. This was a 6-month cohort study extracted from a 24-month prospective cohort study of mother-infant pairs in three communities in Hunan, China. Data about participants' characteristics, delivery methods, breastfeeding initiation, use of formula in the hospital, exclusive breastfeeding, and any breastfeeding were collected at 1, 3, and 6 months following each infant's birth. The chi-square test, logistic regression model, and Cox proportional hazard regression model were used to examine the relationship between breastfeeding practices and cesarean delivery. The number of women who had a cesarean delivery was 387 (40.6%), and 567 (59.4%) women had a vaginal delivery. The exclusive breastfeeding rates at 1, 3, and 6 months were 80.2%, 67.4%, and 21.5%, respectively. Women who had a cesarean delivery showed a lower rate of exclusive breastfeeding and any breastfeeding than those who had a vaginal delivery ( p cesarean delivery was related with using formula in the hospital and delayed breastfeeding initiation. Cesarean delivery also shortened the breastfeeding duration (hazard ratio = 1.40, 95% confidence interval [1.06, 1.84]). Healthcare professionals should provide more breastfeeding skills to women who have a cesarean delivery and warn mothers about the dangers of elective cesarean section for breastfeeding practices.

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

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.

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.

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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

Directory of Open Access Journals (Sweden)

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.)

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

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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.

Fibrinogen concentrate as a treatment for postpartum haemorrhage-induced coagulopathy: A study protocol for a randomised multicentre controlled trial. The fibrinogen in haemorrhage of DELivery (FIDEL) trial.

Science.gov (United States)

Ducloy-Bouthors, Anne-Sophie; Mignon, Alexandre; Huissoud, Cyril; Grouin, Jean-Marie; Mercier, Frédéric J

2016-08-01

Postpartum haemorrhage (PPH) remains the leading cause for maternal mortality worldwide. Hypofibrinogenaemia has been identified as a major risk factor for progress towards severe PPH. The efficacy of fibrinogen concentrate supplementation in PPH has been shown in various clinical settings but the level of evidence is not sufficient to prove the benefit, evaluate the risks, and determine the value, timing and dose of fibrinogen supplementation in PPH. The FIDEL trial objective is to evaluate the impact of a therapeutic strategy based on the early administration of human fibrinogen concentrate compared to the current practice based on late administration in severe PPH patients requiring second line uterotonics. This is a prospective multicentre, randomised, double-blind, placebo-controlled trial. A total of 412 patients will be randomised if they meet the following criteria: female patients≥18 years old, vaginal delivery, PPH requiring IV administration of prostaglandins (sulprostone) after 20 to 30minutes of oxytocin failure. The participants are assigned to receive either fibrinogen 3g or placebo infusions. The primary endpoint is a composite endpoint defined as the percentage of patients losing at least 4g/dL of Hb, and/or requiring a transfusion of at least 2 units of packed red blood cells, within the 48hours following fibrinogen administration. The purpose of this study is to demonstrate the efficacy and safety of an early fibrinogen concentrate infusion in uncontrolled active PPH. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

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

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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.

Lactate in Amniotic Fluid: Predictor of Labor Outcome in Oxytocin-Augmented Primiparas' Deliveries.

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Eva Wiberg-Itzel

Full Text Available One of the major complications related to delivery is labor dystocia, or an arrested labor progress. Many dystocic deliveries end vaginally after administration of oxytocin, but a large numbers of women with labor dystocia will undergo a long and unsafe parturition. As a result of the exertion required in labor, the uterus produces lactate. The uterine production of lactate is mirrored by the level of lactate in amniotic fluid (AFL.To evaluate whether the level of AFL, analysed in a sample of amniotic fluid collected vaginally at arrested labor when oxytocin was needed, could predict labor outcome in nulliparous deliveries.A prospective multicentre study including 3000 healthy primiparous women all with a singleton pregnancy, gestational age 37 to 42 weeks and no maternal /fetal chronic and/or pregnancy-related conditions. A spontaneous onset of labor, regular contractions and cervical dilation ≥ 3 cm were required before the women were invited to take part in the study.AFL, analysed within 30 minutes before augmentation, provides information about delivery outcome. Sensitivity for an acute cesarean section according to high (≥10.1mmol/l or low (12h (p = 0.04, post-partum fever (>38°C, p = 0.01 and post-partum haemorrhage >1.5L (p = 0.04.The AFL is a good predictor of delivery outcome in arrested nulliparous deliveries. Low levels of AFL may support the decision to continue a prolonged vaginal labor by augmentation with oxytocin. A high level of AFL correlates with operative interventions and post-partum complications.

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.

Labor induction and cesarean delivery: A prospective cohort study of first births in Pennsylvania, USA.

Science.gov (United States)

Kjerulff, Kristen H; Attanasio, Laura B; Edmonds, Joyce K; Kozhimannil, Katy B; Repke, John T

2017-09-01

Mode of delivery at first childbirth largely determines mode of delivery at subsequent births, so it is particularly important to understand risk factors for cesarean delivery at first childbirth. In this study, we investigated risk factors for cesarean delivery among nulliparous women, with focus on the association between labor induction and cesarean delivery. A prospective cohort study of 2851 nulliparous women with singleton pregnancies who attempted vaginal delivery at hospitals in Pennsylvania, 2009-2011, was conducted. We used nested logistic regression models and multiple mediational analyses to investigate the role of three groups of variables in explaining the association between labor induction and unplanned cesarean delivery-the confounders of maternal characteristics and indications for induction, and the mediating (intrapartum) factors-including cervical dilatation, labor augmentation, epidural analgesia, dysfunctional labor, dystocia, fetal intolerance of labor, and maternal request of cesarean during labor. More than a third of the women were induced (34.3%) and 24.8% underwent cesarean delivery. Induced women were more likely to deliver by cesarean (35.9%) than women in spontaneous labor (18.9%), unadjusted OR 2.35 (95% CI 1.97-2.79). The intrapartum factors significantly mediated the association between labor induction and cesarean delivery (explaining 76.7% of this association), particularly cervical dilatation <3 cm at hospital admission, fetal intolerance of labor, and dystocia. The indications for labor induction only explained 6.2%. Increased risk of cesarean delivery after labor induction among nulliparous women is attributable mainly to lower cervical dilatation at hospital admission and higher rates of labor complications. © 2017 Wiley Periodicals, Inc.

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

Energy Technology Data Exchange (ETDEWEB)

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.

Intracellular delivery of potential therapeutic genes: prospects in cancer gene therapy.

Science.gov (United States)

Bakhtiar, Athirah; Sayyad, Mustak; Rosli, Rozita; Maruyama, Atsushi; Chowdhury, Ezharul H

2014-01-01

Conventional therapies for malignant cancer such as chemotherapy and radiotherapy are associated with poor survival rates owing to the development of cellular resistance to cancer drugs and the lack of targetability, resulting in unwanted adverse effects on healthy cells and necessitating the lowering of therapeutic dose with consequential lower efficacy of the treatment. Gene therapy employing different types of viral and non-viral carriers to transport gene(s) of interest and facilitating production of the desirable therapeutic protein(s) has tremendous prospects in cancer treatments due to the high-level of specificity in therapeutic action of the expressed protein(s) with diminished off-target effects, although cancer cell-specific delivery of transgene(s) still poses some challenges to be addressed. Depending on the potential therapeutic target genes, cancer gene therapy could be categorized into tumor suppressor gene replacement therapy, immune gene therapy and enzyme- or prodrug-based therapy. This review would shed light on the current progress of delivery of potentially therapeutic genes into various cancer cells in vitro and animal models utilizing a variety of viral and non-viral vectors.

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

Science.gov (United States)

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.

[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.

Science.gov (United States)

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.

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

Science.gov (United States)

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.

Characteristics of acute treatment costs of traumatic brain injury in Eastern China--a multi-centre prospective observational study.

Science.gov (United States)

Yuan, Qiang; Liu, Hua; Wu, Xing; Sun, Yirui; Yao, Haijun; Zhou, Liangfu; Hu, Jin

2012-12-01

This study investigated acute treatment costs and related factors for traumatic brain injuries (TBI) in eastern China based on a prospective multicentre study. Data were prospectively collected from 80 hospitals in eastern China by standardized structured questionnaires during 2004. Included patients were admitted to hospitals via an emergency service with a diagnosis of TBI. The total acute hospitalization treatment costs derived from unsubsidized total hospital billings were used as the main outcome measure. Univariate and multivariable regression models were used to examine factors associated with each outcome. In total, 13,007 TBI cases were identified from 80 hospitals in eastern China. The median cost per hospitalization was $879 US (range, $72-45,894). The median cost per day was $79 (interquartile range, $49-126). The hospitalization costs varied based on the cause of TBI, with a median of $1017 for traffic accidents, $816 for falls, $490 for blows to the head, and $712 for falls. The hospitalization costs also varied by injury type with a mean of $918 for TBI associated with other injuries and $831 for isolated TBI. Using multiple regression analyses, lower admission Glasgow Coma score, longer hospital stay (LOS), male sex, transient patient status, traffic accident, injury occurring on a construction site, treatment at a tertiary hospital, neurosurgical intensive care unit (NICU) or ICU stay, associated polytrauma, and those who needed a neurosurgical operation had significantly higher total acute hospitalization costs than those of other groups. Good recovery and self-paying patients had lower total costs. A double LOS was associated with a 1.61 (95% confidence interval, 1.59-1.62) times higher hospital cost. Our results have potential implications for health-care resource planning during TBI treatment. Measures to prevent traffic accidents and reduce the LOS may help to reduce acute hospitalization costs. Crown Copyright © 2012. Published by Elsevier

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.

Prospective longitudinal cohort study on cumulative 5-year delivery and adoption rates among 1338 couples initiating infertility treatment

DEFF Research Database (Denmark)

Pinborg, A; Hougaard, C O; Andersen, A Nyboe

2009-01-01

occurred for 5.9% (48/817) of the women. Positive prognostic factors for delivery were male infertility, female age infertility and less than three previous treatment cycles. CONCLUSIONS A crude delivery rate of 69.4% in the total population 5 years after referral to tertiary......BACKGROUND The objective was to assess crude 5-year delivery rates after assisted reproductive technology (ART) treatment, intrauterine inseminations (IUI), spontaneous conceptions (SC) and adoptions in a large infertile cohort. METHODS A prospective longitudinal survey comprised 1338 infertile...... couples starting public infertility programmes offering IUIs and three free ART cycles during 2000-2001. The cohort was cross-linked with the National Medical Birth Register to obtain delivery rates for all 1338 couples. More detailed data were available from 817 women responding to a 5-year follow...

Delivery mode and neonatal outcome after a trial of external cephalic version (ECV): a prospective trial of vaginal breech versus cephalic delivery.

Science.gov (United States)

Reinhard, Joscha; Sänger, Nicole; Hanker, Lars; Reichenbach, Lena; Yuan, Juping; Herrmann, Eva; Louwen, Frank

2013-04-01

To examine the delivery mode and neonatal outcome after a trial of external cephalic version (ECV) procedures. This is an interim analysis of an ongoing larger prospective off-centre randomised trial, which compares a clinical hypnosis intervention against neuro-linguistic programming (NLP) of women with a singleton breech foetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. Main outcome measures were delivery mode and neonatal outcome. On the same day after the ECV procedure two patients (2 %), who had unsuccessful ECVs, had Caesarean sections (one due to vaginal bleeding and one due to pathological CTG). After the ECV procedure 40.4 % of women had cephalic presentation (n = 38) and 58.5 % (n = 55) remained breech presentation. One patient remained transverse presentation (n = 1; 1.1 %). Vaginal delivery was observed by 73.7 % of cephalic presentation (n = 28), whereas 26.3 % (n = 10) had in-labour Caesarean sections. Of those, who selected a trial of vaginal breech delivery, 42.4 % (n = 14) delivered vaginally and 57.6 % (n = 19) delivered via Caesarean section. There is a statistically significant difference between the rate of vaginal birth between cephalic presentation and trial of vaginal breech delivery (p = 0.009), however, no difference in neonatal outcome was observed. ECV is a safe procedure and can reduce not only the rate of elective Caesarean sections due to breech presentation but also the rate of in-labour Caesarean sections even if a trial of vaginal breech delivery is attempted.

A multicenter prospective study of neonatal outcomes at less than 32 weeks associated with indications for maternal admission and delivery.

Science.gov (United States)

Garite, Thomas J; Combs, C Andrew; Maurel, Kimberly; Das, Anita; Huls, Kevin; Porreco, Richard; Reisner, Dale; Lu, George; Bush, Melissa; Morris, Bruce; Bleich, April

2017-07-01

Counseling for patients with impending premature delivery traditionally has been based primarily on the projected gestational age at delivery. There are limited data regarding how the indications for the preterm birth affect the neonatal outcome and whether this issue should be taken into account in decisions regarding management and patient counseling. We performed a prospective study of pregnancies resulting in premature delivery at less than 32 weeks to determine the influence of both the indications for admission and their associated indications for delivery on neonatal mortality and complications of prematurity. This is a multicenter, prospective study in 10 hospitals where all data from the neonatal intensive care unit routinely was imported to a deidentified data warehouse. Maternal data were collected prospectively at or near the time of delivery. Eligible subjects included singleton deliveries in these hospitals between 23 0/7 and 31 6/7 weeks. The primary hypothesis of the study was to determine whether there was a difference in the primary outcome, which was defined as neonatal composite morbidity, between those neonates delivered after admission for premature labor vs premature rupture of membranes, because these were expected to be the 2 most frequent diagnoses leading to premature birth. The sample size was calculated based on a 10% difference in outcomes for these 2 entities. We based this hypothesis on the knowledge that premature rupture of membranes has a greater incidence of intra-amniotic infection and inflammation than premature labor and that outcomes for premature neonates are worse when delivery is associated with intra-amniotic infection. Additional outcomes were analyzed for all other indications for admission and delivery. Composite morbidity was defined as ≥1 of the following: respiratory distress syndrome (oxygen requirement, clinical diagnosis, and consistent chest radiograph), bronchopulmonary dysplasia (requirement for oxygen

Determination of prospective displacement-based gate threshold for respiratory-gated radiation delivery from retrospective phase-based gate threshold selected at 4D CT simulation

International Nuclear Information System (INIS)

Vedam, S.; Archambault, L.; Starkschall, G.; Mohan, R.; Beddar, S.

2007-01-01

Four-dimensional (4D) computed tomography (CT) imaging has found increasing importance in the localization of tumor and surrounding normal structures throughout the respiratory cycle. Based on such tumor motion information, it is possible to identify the appropriate phase interval for respiratory gated treatment planning and delivery. Such a gating phase interval is determined retrospectively based on tumor motion from internal tumor displacement. However, respiratory-gated treatment is delivered prospectively based on motion determined predominantly from an external monitor. Therefore, the simulation gate threshold determined from the retrospective phase interval selected for gating at 4D CT simulation may not correspond to the delivery gate threshold that is determined from the prospective external monitor displacement at treatment delivery. The purpose of the present work is to establish a relationship between the thresholds for respiratory gating determined at CT simulation and treatment delivery, respectively. One hundred fifty external respiratory motion traces, from 90 patients, with and without audio-visual biofeedback, are analyzed. Two respiratory phase intervals, 40%-60% and 30%-70%, are chosen for respiratory gating from the 4D CT-derived tumor motion trajectory. From residual tumor displacements within each such gating phase interval, a simulation gate threshold is defined based on (a) the average and (b) the maximum respiratory displacement within the phase interval. The duty cycle for prospective gated delivery is estimated from the proportion of external monitor displacement data points within both the selected phase interval and the simulation gate threshold. The delivery gate threshold is then determined iteratively to match the above determined duty cycle. The magnitude of the difference between such gate thresholds determined at simulation and treatment delivery is quantified in each case. Phantom motion tests yielded coincidence of simulation

STRATEGIES AND PROSPECTS OF NASAL DRUG DELIVERY SYSTEMS

OpenAIRE

Gannu Praveen Kumar

2012-01-01

The recent advancement of nasal drug delivery systems has increased enormously and is gaining significant importance. Intranasal therapy has been an accepted form of treatment in the Ayurvedic system of Indian Medicine. The non-invasive delivery of nasal drug delivery systems made to exploit for the development of successful treatment. The advantages, disadvantages, mechanism of action and application of nasal drug delivery system in local delivery, systematic delivery, nasal vaccines and CNS...

The role of gestational diabetes, pre-pregnancy body mass index and gestational weight gain on the risk of newborn macrosomia: results from a prospective multicentre study

OpenAIRE

Alberico, Salvatore; Montico, Marcella; Barresi, Valentina; Monasta, Lorenzo; Businelli, Caterina; Soini, Valentina; Erenbourg, Anna; Ronfani, Luca; Maso, Gianpaolo

2014-01-01

Background It is crucial to identify in large population samples the most important determinants of excessive fetal growth. The aim of the study was to evaluate the independent role of pre-pregnancy body mass index (BMI), gestational weight gain and gestational diabetes on the risk of macrosomia. Methods A prospective study collected data on mode of delivery and maternal/neonatal outcomes in eleven Hospitals in Italy. Multiple pregnancies and preterm deliveries were excluded. The sample inclu...

Leadership training and delivery prospects of team leaders in Communication Network Support Services Limited, Ilorin

Directory of Open Access Journals (Sweden)

Abdulahi G. Olatunji

2017-10-01

Full Text Available Training and development of staff has been one of the key focuses of every human resources department of any formal work organisation. This is as a result of the realisation that training is an important determinant of people’s behaviour as well as their general delivery ability at work. In realisation of this, intellectuals and researchers in industrial relations generally have put vested interest in the phenomena of training and work delivery ability. However, despite the enormous volume of literatures available in this regard, very few among them have specifically examined the importance of leadership training as a possible determinant of work delivery. Thus, this study is an attempt to cover this gap. In order to achieve this objective, survey design was used as the research design for the study. A questionnaire was used to elicit information from the respondents, while simple random sampling technique was used to select the study sample. Frequency distribution and percentage were used as descriptive tools, while chi-square was used as an inferential statistical tool in the study. The study found out that leadership training has a significant relationship with the identified work delivery elements measured in the study. The study concluded that leadership training has a significant effect on delivery ability of team leaders and thus recommended that leadership training should be given utmost priority in work organisations so that work delivery prospects of the employees could be realised.

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

Energy Technology Data Exchange (ETDEWEB)

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.)

The effect of maternal fasting during Ramadan on preterm delivery: a prospective cohort study.

Science.gov (United States)

Awwad, J; Usta, I M; Succar, J; Musallam, K M; Ghazeeri, G; Nassar, A H

2012-10-01

To determine the effect of fasting during the month of Ramadan on the rate of preterm delivery (PTD). A prospective cohort study of women with singleton pregnancies who elected to fast and matched controls. Four medical centres in Beirut, Lebanon. Women presenting for prenatal care (20-34 weeks of gestation) during the month of Ramadan, September 2008. Data were collected prospectively. The frequency of PTD was evaluated in relation to the duration of fasting and the stage of gestation at the time of fasting. The primary endpoint was the percentage of pregnant women who had PTD, defined as delivery before 37 completed weeks of gestation. A total of 468 women were approached, of whom 402 were included in the study. There were no differences in smoking history and employment. There was no difference in the proportion of women who had PTD at Ramadan-fasted group and the controls, respectively. The PTD rate was also similar in those who fasted before or during the third trimester. The mean birthweight was lower (3094 ± 467 g versus 3202 ± 473 g, P = 0.024) and the rate of ketosis and ketonuria was higher in the Ramadan-fasted women. On multivariate stepwise logistic regression analysis, fasting was not associated with an increased risk of PTD (odds ratio 0.72; 95% confidence interval 0.34-1.54; P = 0.397). The only factor that had a significant effect on the PTD rate was body mass index (odds ratio 0.43; 95% confidence interval 0.20-0.93; P = 0.033). Fasting during the month of Ramadan does not seem to increase the baseline risk of preterm delivery in pregnant women regardless of the gestational age during which this practice is observed. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

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

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.

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.

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 ...

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

Mode of Delivery according to Leisure Time Physical Activity before and during Pregnancy

DEFF Research Database (Denmark)

Nielsen, Emilie Nor; Andersen, Per Kragh; Hegaard, Hanne Kristine

2017-01-01

Objectives: To examine the association between maternal leisure time physical activity and mode of delivery. Study Design: Population-based multicentre cohort. From the Danish Dystocia Study, we included 2,435 nulliparous women, who delivered a singleton infant in cephalic presentation at term...... increasing leisure time physical activity before and during pregnancy associated with a less complicated delivery among low-risk, nulliparous women....... with statistically significant trends at all four time stages except the third trimester. This tendency was confirmed in the proportional odds model showing 28% higher odds of a more complicated mode of delivery among women with a low activity level compared to moderately active women. Conclusions: We found...

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'

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

Directory of Open Access Journals (Sweden)

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.

Mode of Delivery and Long-Term Health-Related Quality-of-Life Outcomes: A Prospective Population-Based Study.

Science.gov (United States)

Petrou, Stavros; Kim, Sung Wook; McParland, Penny; Boyle, Elaine M

2017-06-01

Relatively little is known about the effects of mode of delivery on long-term health-related quality-of-life outcomes. Furthermore, no previous study has expressed these outcomes in preference-based (utility) metrics. The study population comprised 2,161 mothers recruited from a prospective population-based study in the East Midlands of England encompassing live births and stillbirths between 32 +0 and 36 +6 weeks' gestation and a sample of term-born controls. Perinatal data were extracted from the mothers' maternity records. Health-related quality-of-life outcomes were assessed at 12 months postpartum, using the EuroQol Five Dimensions (EQ-5D) measure with responses to the EQ-5D descriptive system converted into health utility scores. Descriptive statistics and multivariable analyses were used to estimate the relationship between the mode of delivery and health-related quality-of-life outcomes. The overall health-related quality-of-life profile of the women in the study cohort mirrored that of the English adult population as revealed by national health surveys. A significantly higher proportion of women delivering by cesarean delivery reported some, moderate, severe, or extreme pain or discomfort at 12 months postpartum than women undergoing spontaneous vaginal delivery. Multivariable analyses, using the Ordinary Least Squares estimator revealed that, after controlling for maternal sociodemographic characteristics, cesarean delivery without maternal or fetal compromise was associated with a significant EQ-5D utility decrement in comparison to spontaneous vaginal delivery among all women (-0.026; p = 0.038) and among mothers of term-born infants (-0.062; p quality of life in comparison to spontaneous vaginal delivery. Further longitudinal studies are needed to understand the magnitude, trajectory, and underpinning mechanisms of health-related quality-of-life outcomes following different modes of delivery. © 2016 Wiley Periodicals, Inc.

Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

Science.gov (United States)

Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

2011-12-01

Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p Itopride was an effective and well tolerated drug in the management of FD in this patient population.

The role of dosimetry audit in lung SBRT multi-centre clinical trials.

Science.gov (United States)

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.

Influence of quality of care and individual patient characteristics on quality of life and return to work in survivors of the acute respiratory distress syndrome: protocol for a prospective, observational, multi-centre patient cohort study (DACAPO).

Science.gov (United States)

Brandstetter, Susanne; Dodoo-Schittko, Frank; Blecha, Sebastian; Sebök, Philipp; Thomann-Hackner, Kathrin; Quintel, Michael; Weber-Carstens, Steffen; Bein, Thomas; Apfelbacher, Christian

2015-12-17

Health-related quality of life (HRQoL) and return to work are important outcomes in critical care medicine, reaching beyond mortality. Little is known on factors predictive of HRQoL and return to work in critical illness, including the acute respiratory distress syndrome (ARDS), and no evidence exists on the role of quality of care (QoC) for outcomes in survivors of ARDS. It is the aim of the DACAPO study ("Surviving ARDS: the influence of QoC and individual patient characteristics on quality of life") to investigate the role of QoC and individual patient characteristics on quality of life and return to work. A prospective, observational, multi-centre patient cohort study will be performed in Germany, using hospitals from the "ARDS Network Germany" as the main recruiting centres. It is envisaged to recruit 2400 patients into the DACAPO study and to analyse a study population of 1500 survivors. They will be followed up until 12 months after discharge from hospital. QoC will be assessed as process quality, structural quality and volume at the institutional level. The main outcomes (HRQoL and return to work) will be assessed by self-report questionnaires. Further data collection includes general medical and ARDS-related characteristics of patients as well as sociodemographic and psycho-social parameters. Multilevel hierarchical modelling will be performed to analyse the effects of QoC and individual patient characteristics on outcomes, taking the cluster structure of the data into account. By obtaining comprehensive data at patient and hospital level using a prospective multi-centre design, the DACAPO-study is the first study investigating the influence of QoC on individual outcomes of ARDS survivors.

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

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

Homeopathy in chronic sinusitis: a prospective multi-centric observational study.

Science.gov (United States)

Nayak, Chaturbhuja; Singh, Vikram; Singh, V P; Oberai, Praveen; Roja, Varanasi; Shitanshu, Shashi Shekhar; Sinha, M N; Deewan, Deepti; Lakhera, B C; Ramteke, Sunil; Kaushik, Subhash; Sarkar, Sarabjit; Mandal, N R; Mohanan, P G; Singh, J R; Biswas, Sabyasachi; Mathew, Georgekutty

2012-04-01

The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS). Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6 months. Statistical analysis was done using SPSS version 16. 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment. Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation. Copyright © 2012 Elsevier Ltd. All rights reserved.

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

Determinants of facility delivery after implementation of safer mother programme in Nepal: a prospective cohort study.

Science.gov (United States)

Karkee, Rajendra; Binns, Colin W; Lee, Andy H

2013-10-20

There are several barriers for pregnant women to deliver in a health care facility. This prospective cohort study investigated factors affecting facility delivery and reasons for unplanned place of delivery after implementation of the safer mother programme in Nepal. Baseline interviews using a validated questionnaire were conducted on a sample of 700 pregnant women representative of the Kaski district in central Nepal. Follow-up interviews of the cohort were then conducted within 45 days postpartum. Stepwise logistic regression analysis was performed to determine factors associated with the facility delivery outcome. Of the 644 pregnant women whose delivery location had been identified, 547 (85%) gave birth in a health care facility. Women were more likely to deliver in a health facility if they were educated especially with higher secondary or above qualification (adjusted odds ratio (OR) 12.39, 95% confidence interval (CI) 5.09 to 30.17), attended 4 or more antenatal care visits (OR 2.15, 95% CI 1.25 to 3.69), and lived within 30 minutes to the facility (OR 11.61, 95% CI 5.77 to 24.04). For the 97 women who delivered at home, 72 (74.2%) were unplanned, mainly due to quick precipitation of labour making it impossible to reach a health facility. It appeared that facility delivery occurs more frequent among educated women and those who live nearby, even though maternity services are now freely available in Nepal. Because of the difficult terrain and transportation problem in rural areas, interventions that make maternity service physically accessible during antenatal period are needed to increase the utilisation of health facility for child birth.

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.

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.

Risk of Asthma from Cesarean Delivery Depends on Membrane Rupture

DEFF Research Database (Denmark)

Sevelsted, Astrid; Stokholm, Jakob; Bisgaard, Hans

2016-01-01

in Childhood2000 is a high-risk birth cohort of 411 Danish children. Asthma was diagnosed prospectively by physicians at the research site, and associations with cesarean delivery were investigated using Cox proportional hazard models. From the Danish national prospective registry we included data from 1997......-2010. Childhood asthma was defined from recurrent use of inhaled corticosteroids filled at pharmacies. Cesarean delivery was classified as either before or after rupture of membranes, and the risk of asthma was compared with vaginal delivery. Results were adjusted stepwise for age and calendar year, sex, birth...... weight, gestational age, multiple births, parity, and maternal factors (age, smoking/antibiotics during pregnancy, employment status, and asthma). RESULTS: In the Copenhagen Prospective Studies on Asthma in Childhood2000 cohort, the adjusted hazard ratio for asthma was increased by cesarean delivery...

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.

Directory of Open Access Journals (Sweden)

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

Women's preferences and mode of delivery in public and private hospitals: a prospective cohort study.

Science.gov (United States)

Mazzoni, Agustina; Althabe, Fernando; Gutierrez, Laura; Gibbons, Luz; Liu, Nancy H; Bonotti, Ana María; Izbizky, Gustavo H; Ferrary, Marta; Viergue, Nora; Vigil, Silvia I; Zalazar Denett, Gabriela; Belizán, José M

2016-02-08

Rates of caesarean section have steadily increased in most middle- and high-income countries over the last few decades without medical justification. Maternal request is one of the frequently cited non-medical factors contributing to this trend. The objectives of this study were to assess pregnant women's preferences regarding mode of delivery and to compare actual caesarean section rates in the public and private sectors. A prospective cohort study was conducted in two public and three private hospitals in Buenos Aires, Argentina. 382 nulliparous pregnant women (183 from the private sector and 199 from the public sector) aged 18 to 35 years, with single pregnancies over 32 weeks of gestational age were enrolled during antenatal care visits between October 2010 and September 2011. We excluded women with pregnancies resulting from assisted fertility, women with known pre-existing major diseases or, with pregnancy complications, or with a medical indication of elective cesarean section. We used two different approaches to assess women's preferences: a survey using a tailored questionnaire, and a discrete choice experiment. Only 8 and 6% of the healthy nulliparous women in the public and private sectors, respectively, expressed a preference for caesarean section. Fear of pain and safety were the most frequently expressed reasons for preferring caesarean section. When reasons for delivery mode were assessed by a discrete choice experiment, women placed the most emphasis on sex after childbirth. Of women who expressed their preference for vaginal delivery, 34 and 40% ended their pregnancies by caesarean section in public and private hospitals, respectively. The preference for caesarean section is low among healthy nulliparous women in Buenos Aires. The reasons why these women had a rate of more than 35% caesarean sections are unlikely related to their preferences for mode of delivery.

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

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

Directory of Open Access Journals (Sweden)

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.

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...

Health Care Delivery.

Science.gov (United States)

Starfield, Barbara

1987-01-01

The article reviews emerging health care delivery options for handicapped children. Cost structures, quality of care, and future prospects are considered for Health Maintenance Organizations, Preferred Provider Organizations, Tax Supported Direct Service Programs, Hospital-Based Services, and Ambulatory Care Organizations. (Author/DB)

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

Science.gov (United States)

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.

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.

99mTc-DTPA aerosol for same-day post-perfusion ventilation imaging: Results of a multicentre study

International Nuclear Information System (INIS)

Koehn, H.; Koenig, B.; Bachmayr, S.; Markt, B.; Eber, O.; Lind, P.; Galvan, G.; Rettenbacher, L.; Holm, C.; Ogris, E.

1993-01-01

A multicentre study was performed in an attempt to evaluate a submicronic technetium-99m diethylene triamine penta-acetic acid aerosol generated by a newly developed delivery system, the aerosol production equipment (APE nebulizer), for same-day post-perfusion ventilation imaging in patients with clinically suspected pulmonary embolism. Quantitative comparison between the DTPA aerosol and krypton gas demonstrated a close correlation with respect to regional pulmonary distribution of activity and peripheral lung penetration (n=14, r=0.94, P 99m Tc-labelled DTPA aerosol is well suited for fast same-day post-perfusion ventilation imaging in patients with clinical suspicion of pulmonary embolism. (orig.)

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.

Effects of periodontal treatment on carotid intima-media thickness in patients with lifestyle-related diseases: Japanese prospective multicentre observational study.

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Kudo, Chieko; Shin, Wee Soo; Sasaki, Nobuhiro; Harai, Kazuo; Kato, Kai; Seino, Hiroaki; Goke, Eiji; Fujino, Takemasa; Kuribayashi, Nobuichi; Pearce, Youko Onuki; Taira, Masato; Matsushima, Ryoji; Minabe, Masato; Takashiba, Shogo

2018-01-12

Atherosclerosis, a chronic inflammatory disease in arterial blood vessels, is one of the major causes of death in worldwide. Meanwhile, periodontal disease is a chronic inflammatory disease caused by infection with periodontal pathogens such as P. gingivalis (Porphyromonas gingivalis). Several studies have reported association between periodontal infection and atherosclerosis, but direct investigation about the effects of periodontal treatment on atherosclerosis has not been reported. We have planned Japanese local clinics to determine the relationship between periodontal disease and atherosclerosis under collaborative with medical and dental care. A prospective, multicentre, observational study was conducted including 38 medical patients with lifestyle-related diseases in the stable period under consultation at participating medical clinics and 92 periodontal patients not undergoing medical treatment but who were consulting at participating dental clinics. Systemic and periodontal examinations were performed before and after periodontal treatment. At baseline, LDL-C (low-density lipoprotein cholesterol) levels and percentage (%) of mobile teeth were positively related to plasma IgG (immunoglobulin) antibody titer against P. gingivalis with multivariate analysis. Corresponding to improvements in periodontal clinical parameters after treatment, right and left max IMT (maximum intima-media thickness) levels were decreased significantly after treatment (SPT-S: start of supportive periodontal therapy, SPT-1y: at 1 year under SPT, and SPT-3y: at 3 years under SPT). The present study has clarified our previous univariate analysis results, wherein P. gingivalis infection was positively associated with progression of atherosclerosis. Thus, routine screening using plasma IgG antibody titer against P. gingivalis and periodontal treatment under collaborative with medical and dental care may prevent cardiovascular accidents caused by atherosclerosis.

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

Oral transmucosal drug delivery--current status and future prospects.

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Sattar, Mohammed; Sayed, Ossama M; Lane, Majella E

2014-08-25

Oral transmucosal drug delivery (OTDD) dosage forms have been available since the 1980s. In contrast to the number of actives currently delivered locally to the oral cavity, the number delivered as buccal or sublingual formulations remains relatively low. This is surprising in view of the advantages associated with OTDD, compared with conventional oral drug delivery. This review examines a number of aspects related to OTDD including the anatomy of the oral cavity, models currently used to study OTDD, as well as commercially available formulations and emerging technologies. The limitations of current methodologies to study OTDD are considered as well as recent publications and new approaches which have advanced our understanding of this route of drug delivery. Copyright © 2014 Elsevier B.V. All rights reserved.

Gene therapy prospects--intranasal delivery of therapeutic genes.

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Podolska, Karolina; Stachurska, Anna; Hajdukiewicz, Karolina; Małecki, Maciej

2012-01-01

Gene therapy is recognized to be a novel method for the treatment of various disorders. Gene therapy strategies involve gene manipulation on broad biological processes responsible for the spreading of diseases. Cancer, monogenic diseases, vascular and infectious diseases are the main targets of gene therapy. In order to obtain valuable experimental and clinical results, sufficient gene transfer methods are required. Therapeutic genes can be administered into target tissues via gene carriers commonly defined as vectors. The retroviral, adenoviral and adeno-associated virus based vectors are most frequently used in the clinic. So far, gene preparations may be administered directly into target organs or by intravenous, intramuscular, intratumor or intranasal injections. It is common knowledge that the number of gene therapy clinical trials has rapidly increased. However, some limitations such as transfection efficiency and stable and long-term gene expression are still not resolved. Consequently, great effort is focused on the evaluation of new strategies of gene delivery. There are many expectations associated with intranasal delivery of gene preparations for the treatment of diseases. Intranasal delivery of therapeutic genes is regarded as one of the most promising forms of pulmonary gene therapy research. Gene therapy based on inhalation of gene preparations offers an alternative way for the treatment of patients suffering from such lung diseases as cystic fibrosis, alpha-1-antitrypsin defect, or cancer. Experimental and first clinical trials based on plasmid vectors or recombinant viruses have revealed that gene preparations can effectively deliver therapeutic or marker genes to the cells of the respiratory tract. The noninvasive intranasal delivery of gene preparations or conventional drugs seems to be very encouraging, although basic scientific research still has to continue.

Multicentric Giant Cell Tumor of Bone: Synchronous and Metachronous Presentation

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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.

Impact of harmful use of alcohol on the sedation of critical patients on mechanical ventilation: A multicentre prospective, observational study in 8 Spanish intensive care units.

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Sandiumenge, A; Torrado, H; Muñoz, T; Alonso, M Á; Jiménez, M J; Alonso, J; Pardo, C; Chamorro, C

2016-05-01

To evaluate the impact of a history of harmful use of alcohol (HUA) on sedoanalgesia practices and outcomes in patients on mechanical ventilation (MV). A prospective, observational multicentre study was made of all adults consecutively admitted during 30 days to 8 Spanish ICUs. Patients on MV >24h were followed-up on until discharge from the ICU or death. Data on HUA, smoking, the use of illegal (IP) and medically prescribed psychotropics (MPP), sedoanalgesia practices and their related complications (sedative failure [SF] and sedative withdrawal [SW]), as well as outcome, were prospectively recorded. A total of 23.4% (119/509) of the admitted patients received MV >24h; 68.9% were males; age 57.0 (17.9) years; APACHE II score 18.8 (7.2); with a medical cause of admission in 53.9%. Half of them consumed at least one psychotropic agent (smoking 27.7%, HUA 25.2%; MPP 9.2%; and IP 7.6%). HUA patients more frequently required PS (86.7% vs. 64%; p2 sedatives (56.7% vs. 28.1%; p<0.02). HUA was associated to an eightfold (p<0.001) and fourfold (p<0.02) increase in SF and SW, respectively. In turn, the duration of MV and the stay in the ICU was increased by 151h (p<0.02) and 4.4 days (p<0.02), respectively, when compared with the non-HUA group. No differences were found in terms of mortality. HUA may be associated to a higher risk of SF and WS, and can prolong MV and the duration of stay in the ICU in critical patients. Early identification could allow the implementation of specific sedation strategies aimed at preventing these complications. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

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.

Meal frequency patterns and glycemic properties of maternal diet in relation to preterm delivery: Results from a large prospective cohort study.

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Englund-Ögge, Linda; Birgisdottir, Bryndis Eva; Sengpiel, Verena; Brantsæter, Anne Lise; Haugen, Margareta; Myhre, Ronny; Meltzer, Helle Margrete; Jacobsson, Bo

2017-01-01

Dietary habits are linked to high maternal glucose levels, associated with preterm delivery. The aim of this study was to examine the associations between meal frequency and glycemic properties of maternal diet in relation to preterm delivery. This prospective cohort study included 66,000 women from the Norwegian Mother and Child Cohort Study (MoBa). Meal frequency and food intake data were obtained from a validated food frequency questionnaire during mid-pregnancy. Principal component factor analysis was used with a data-driven approach, and three meal frequency patterns were identified: "snack meal", "main meal", and "evening meal". Pattern scores were ranked in quartiles. Glycemic index and glycemic load were estimated from table values. Intakes of carbohydrates, added sugar, and fiber were reported in grams per day and divided into quartiles. Gestational age was obtained from the Medical Birth Registry of Norway. Preterm delivery was defined as birth at meal" pattern was associated with a reduced risk of preterm delivery, with hazard ratios (HRs) of 0.89 (95% confidence interval (CI): 0.80, 0.98) and 0.90 (95% CI: 0.81, 0.99) for the third and fourth quartiles, respectively, and p for trend of 0.028. This was mainly attributed to the group of women with BMI ≥25 kg/m2, with HRs of 0.87 (95% CI: 0.79, 0.96) and 0.89 (95% CI: 0.80, 0.98) for the third and fourth quartiles, respectively, and p for trend of 0.010. There was no association between glycemic index, glycemic load, carbohydrates, added sugar, fiber, or the remaining meal frequency patterns and preterm delivery. Regular consumption of main meals (breakfast, lunch, dinner) was associated with a lower risk of preterm delivery. Diet should be further studied as potential contributing factors for preterm delivery.

Transmembrane transport of peptide type compounds: prospects for oral delivery

Science.gov (United States)

Lipka, E.; Crison, J.; Amidon, G. L.

1996-01-01

Synthesis and delivery of potential therapeutic peptides and peptidomimetic compounds has been the focus of intense research over the last 10 years. While it is widely recognized that numerous limitations apply to oral delivery of peptides, some of the limiting factors have been addressed and their mechanisms elucidated, which has lead to promising strategies. This article will briefly summarize the challenges, results and current approaches of oral peptide delivery and give some insight on future strategies. The barriers determining peptide bioavailability after oral administration are intestinal membrane permability, size limitations, intestinal and hepatic metabolism and in some cases solubility limitations. Poor membrane permeabilities of hydrophilic peptides might be overcome by structurally modifying the compounds, thus increasing their membrane partition characteristics and/or their affinity to carrier proteins. Another approach is the site-specific delivery of the peptide to the most permeable parts of the intestine. The current view on size limitation for oral drug delivery has neglected partition considerations. Recent studies suggest that compounds with a molecular weight up to 4000 might be significantly absorbed, assuming appropriate partition behavior and stability. Metabolism, probably the most significant factor in the absorption fate of peptides, might be controlled by coadministration of competitive enzyme inhibitors, structural modifications and administration of the compound as a well absorbed prodrug that is converted into the therapeutically active agent after its absorption. For some peptides poor solubility might present a limitation to oral absorption, an issue that has been addressed by mechanistically defining and therefore improving formulation parameters. Effective oral peptide delivery requires further development in understanding these complex mechanisms in order to maximize the therapeutic potential of this class of compounds.

Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in 1130 children: results of an European prospective multicenter observational postauthorization safety study (PASS)

NARCIS (Netherlands)

Sümpelmann, Robert; Kretz, Franz-Josef; Luntzer, Robert; de Leeuw, Thomas G.; Mixa, Vladimir; Gäbler, Ralf; Eich, Christoph; Hollmann, Markus W.; Osthaus, Wilhelm A.

2012-01-01

Introduction: Third-generation hydroxyethyl starch (HES) is now approved also for the use in children, but safety studies including large numbers of pediatric patients are still missing. Therefore, we performed an European multicentric prospective observational postauthorization safety study (PASS)

Portable Video Media Versus Standard Verbal Communication in Surgical Information Delivery to Nurses: A Prospective Multicenter, Randomized Controlled Crossover Trial.

Science.gov (United States)

Kam, Jonathan; Ainsworth, Hannah; Handmer, Marcus; Louie-Johnsun, Mark; Winter, Matthew

2016-10-01

Continuing education of health professionals is important for delivery of quality health care. Surgical nurses are often required to understand surgical procedures. Nurses need to be aware of the expected outcomes and recognize potential complications of such procedures during their daily work. Traditional educational methods, such as conferences and tutorials or informal education at the bedside, have many drawbacks for delivery of this information in a universal, standardized, and timely manner. The rapid uptake of portable media devices makes portable video media (PVM) a potential alternative to current educational methods. To compare PVM to standard verbal communication (SVC) for surgical information delivery and educational training for nurses and evaluate its impact on knowledge acquisition and participant satisfaction. Prospective, multicenter, randomized controlled crossover trial. Two hospitals: Gosford District Hospital and Wyong Hospital. Seventy-two nursing staff (36 at each site). Information delivery via PVM--7-minute video compared to information delivered via SVC. Knowledge acquisition was measured by a 32-point questionnaire, and satisfaction with the method of education delivery was measured using the validated Client Satisfaction Questionnaire (CSQ-8). Knowledge acquisition was higher via PVM compared to SVC 25.9 (95% confidence interval [CI] 25.2-26.6) versus 24.3 (95% CI 23.5-25.1), p = .004. Participant satisfaction was higher with PVM 29.5 (95% CI 28.3-30.7) versus 26.5 (95% CI 25.1-27.9), p = .003. Following information delivery via SVC, participants had a 6% increase in knowledge scores, 24.3 (95% CI 23.5-25.1) versus 25.7 (95% CI 24.9-26.5) p = .001, and a 13% increase in satisfaction scores, 26.5 (95% CI 25.1-27.9) versus 29.9 (95% CI 28.8-31.0) p < .001, when they crossed-over to information delivery via PVM. PVM provides a novel method for providing education to nurses that improves knowledge retention and satisfaction with the

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

Meal frequency patterns and glycemic properties of maternal diet in relation to preterm delivery: Results from a large prospective cohort study.

Directory of Open Access Journals (Sweden)

Linda Englund-Ögge

Full Text Available Dietary habits are linked to high maternal glucose levels, associated with preterm delivery. The aim of this study was to examine the associations between meal frequency and glycemic properties of maternal diet in relation to preterm delivery.This prospective cohort study included 66,000 women from the Norwegian Mother and Child Cohort Study (MoBa. Meal frequency and food intake data were obtained from a validated food frequency questionnaire during mid-pregnancy. Principal component factor analysis was used with a data-driven approach, and three meal frequency patterns were identified: "snack meal", "main meal", and "evening meal". Pattern scores were ranked in quartiles. Glycemic index and glycemic load were estimated from table values. Intakes of carbohydrates, added sugar, and fiber were reported in grams per day and divided into quartiles. Gestational age was obtained from the Medical Birth Registry of Norway. Preterm delivery was defined as birth at <37 gestational weeks. A Cox regression model was used to assess associations with preterm delivery.After adjustments, the "main meal" pattern was associated with a reduced risk of preterm delivery, with hazard ratios (HRs of 0.89 (95% confidence interval (CI: 0.80, 0.98 and 0.90 (95% CI: 0.81, 0.99 for the third and fourth quartiles, respectively, and p for trend of 0.028. This was mainly attributed to the group of women with BMI ≥25 kg/m2, with HRs of 0.87 (95% CI: 0.79, 0.96 and 0.89 (95% CI: 0.80, 0.98 for the third and fourth quartiles, respectively, and p for trend of 0.010. There was no association between glycemic index, glycemic load, carbohydrates, added sugar, fiber, or the remaining meal frequency patterns and preterm delivery.Regular consumption of main meals (breakfast, lunch, dinner was associated with a lower risk of preterm delivery. Diet should be further studied as potential contributing factors for preterm delivery.

Prediction of cesarean delivery in the term nulliparous woman: results from the prospective, multicenter Genesis study.

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Burke, Naomi; Burke, Gerard; Breathnach, Fionnuala; McAuliffe, Fionnuala; Morrison, John J; Turner, Michael; Dornan, Samina; Higgins, John R; Cotter, Amanda; Geary, Michael; McParland, Peter; Daly, Sean; Cody, Fiona; Dicker, Pat; Tully, Elizabeth; Malone, Fergal D

2017-06-01

In contemporary practice many nulliparous women require intervention during childbirth such as operative vaginal delivery or cesarean delivery (CD). Despite the knowledge that the increasing rate of CD is associated with increasing maternal age, obesity and larger infant birthweight, we lack a reliable method to predict the requirement for such potentially hazardous obstetric procedures during labor and delivery. This issue is important, as there are greater rates of morbidity and mortality associated with unplanned CD performed in labor compared with scheduled CDs. A prediction algorithm to identify women at risk of an unplanned CD could help reduced labor associated morbidity. In this primary analysis of the Genesis study, our objective was to prospectively assess the use of prenatally determined, maternal and fetal, anthropomorphic, clinical, and ultrasound features to develop a predictive tool for unplanned CD in the term nulliparous woman, before the onset of labor. The Genesis study recruited 2336 nulliparous women with a vertex presentation between 39+0 and 40+6 weeks' gestation in a prospective multicenter national study to examine predictors of CD. At recruitment, a detailed clinical evaluation and ultrasound assessment were performed. To reduce bias from knowledge of these data potentially influencing mode of delivery, women, midwives, and obstetricians were blinded to the ultrasound data. All hypothetical prenatal risk factors for unplanned CD were assessed as a composite. Multiple logistic regression analysis and mathematical modeling was used to develop a risk evaluation tool for CD in nulliparous women. Continuous predictors were standardized using z scores. From a total enrolled cohort of 2336 nulliparous participants, 491 (21%) had an unplanned CD. Five parameters were determined to be the best combined predictors of CD. These were advancing maternal age (odds ratio [OR], 1.21; 95% confidence interval [CI], 1.09 to 1.34), shorter maternal height (OR

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

Help-seeking and antibiotic prescribing for acute cough in a Chinese primary care population: a prospective multicentre observational study.

Science.gov (United States)

Wong, Carmen Ka Man; Liu, Zhaomin; Butler, Chris C; Wong, Samuel Yeung Shan; Fung, Alice; Chan, Dicken; Yip, Benjamin Hon Kei; Kung, Kenny

2016-01-21

Acute cough is a common reason to prescribe antibiotics in primary care. This study aimed to explore help-seeking and antibiotic prescribing for acute cough in Chinese primary care population. This is a prospective multicentre observational study that included adults presenting with acute cough. Clinicians recorded patients' presenting symptoms, examination findings and medication prescription. Patients completed symptom diaries for up to 28 days by charting their symptom severity and recovery. Adjusted binary logistic regression models identified factors independently associated with antibiotic prescription. Primary care clinicians (n=19) recruited 455 patients. A total of 321 patients (70.5%) returned their completed symptom diaries. Concern about illness severity (41.6%) and obtaining a prescription for symptomatic medications (45.9%), rather than obtaining a prescription for antibiotics, were the main reasons for consulting. Antibiotics were prescribed for 6.8% (n=31) of patients, of which amoxicillin was the most common antimicrobial prescribed (61.3%), as it was associated with clinicians' perception of benefit from antibiotic treatment (odds ratio (OR): 25.9, 95% confidence interval (CI): 6.7-101.1), patients' expectation for antibiotics (OR: 5.1, 95% CI: 1.7-11.6), anticipation (OR: 5.1, 95% CI: 1.6-15.0) and request for antibiotics (OR 15.7, 95% CI: 5.0-49.4), as well as the severity of respiratory symptoms (cough, sputum, short of breath and wheeze OR: 2.7-3.7, all Pantibiotic prescription rates between private primary care clinicians and public primary care clinicians (17.4 vs 1.6%, P=0.00). Symptomatic medication was prescribed in 98.0% of patients. Mean recovery was 9 days for cough and 10 days for all symptoms, which was not significantly associated with antibiotic treatment. Although overall antibiotic-prescribing rates were low, there was a higher rate of antibiotic prescribing among private primary care clinicians, which warrants further

A prospective cohort study of the morbidity associated with operative vaginal deliveries performed by day and at night.

Science.gov (United States)

Butler, Katherine; Ramphul, Meenakshi; Dunney, Clare; Farren, Maria; McSweeney, Aoife; McNamara, Karen; Murphy, Deirdre J

2014-10-29

To evaluate maternal and neonatal outcomes associated with operative vaginal deliveries (OVDs) performed by day and at night. Prospective cohort study. Urban maternity unit in Ireland with off-site consultant staff at night. All nulliparous women requiring an OVD with a term singleton fetus in a cephalic presentation from February to November 2013. Delivery outcomes were compared for women who delivered by day (08:00-19:59) or at night (20:00-07:59). The main outcomes included postpartum haemorrhage (PPH), anal sphincter tear and neonatal unit admission. Procedural factors included operator grade, sequential use of instruments and caesarean section. Of the 597 women who required an OVD, 296 (50%) delivered at night. Choice of instrument, place of delivery, sequential use of instruments and caesarean section did not differ significantly in relation to time of birth. Mid-grade operators performed less OVDs by day than at night, OR 0.60 (95% CI 0.43 to 0.83), and a consultant supervisor was more frequently present by day, OR 2.26 (95% CI 1.05 to 4.83). Shoulder dystocia occurred more commonly by day, OR 2.57 (95% CI 1.05 to 6.28). The incidence of PPH, anal sphincter tears, neonatal unit admission, fetal acidosis and neonatal trauma was similar by day and at night. The mean decision to delivery intervals were 12.0 and 12.6 min, respectively. There was no evidence of an association between time of OVD and adverse perinatal outcomes despite off-site consultant obstetric support at night. 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.

Multi-centre audit of VMAT planning and pre-treatment verification.

Science.gov (United States)

Jurado-Bruggeman, Diego; Hernández, Victor; Sáez, Jordi; Navarro, David; Pino, Francisco; Martínez, Tatiana; Alayrach, Maria-Elena; Ailleres, Norbert; Melero, Alejandro; Jornet, Núria

2017-08-01

We performed a multi-centre intercomparison of VMAT dose planning and pre-treatment verification. The aims were to analyse the dose plans in terms of dosimetric quality and deliverability, and to validate whether in-house pre-treatment verification results agreed with those of an external audit. The nine participating centres encompassed different machines, equipment, and methodologies. Two mock cases (prostate and head and neck) were planned using one and two arcs. A plan quality index was defined to compare the plans and different complexity indices were calculated to check their deliverability. We compared gamma index pass rates using the centre's equipment and methodology to those of an external audit (global 3D gamma, absolute dose differences, 10% of maximum dose threshold). Log-file analysis was performed to look for delivery errors. All centres fulfilled the dosimetric goals but plan quality and delivery complexity were heterogeneous and uncorrelated, depending on the manufacturer and the planner's methodology. Pre-treatment verifications results were within tolerance in all cases for gamma 3%-3mm evaluation. Nevertheless, differences between the external audit and in-house measurements arose due to different equipment or methodology, especially for 2%-2mm criteria with differences up to 20%. No correlation was found between complexity indices and verification results amongst centres. All plans fulfilled dosimetric constraints, but plan quality and complexity did not correlate and were strongly dependent on the planner and the vendor. In-house measurements cannot completely replace external audits for credentialing. Copyright © 2017 Elsevier B.V. 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.

Antibiotic prescribing in women during and after delivery in a non-teaching, tertiary care hospital in Ujjain, India: a prospective cross-sectional study.

Science.gov (United States)

Sharma, Megha; Sanneving, Linda; Mahadik, Kalpana; Santacatterina, Michele; Dhaneria, Suryaprakash; Stålsby Lundborg, Cecilia

2013-01-01

Antibacterial drugs (hereafter referred to as antibiotics) are crucial to treat infections during delivery and postpartum period to reduce maternal mortality. Institutional deliveries have the potential to save lives of many women but extensive use of antibiotics, add to the development and spread of antibiotic resistance. The aim of this study was to present antibiotic prescribing among inpatients during and after delivery in a non-teaching, tertiary care hospital in the city of Ujjain, Madhya Pradesh, India. A prospective cross-sectional study was conducted including women having had either a vaginal delivery or a cesarean section in the hospital. Trained nursing staff collected the data on daily bases, using a specific form attached to each patient file. Statistical analysis, including bivariate and multivariable logistic regression was conducted. Of the total 1077 women, 566 (53%) had a vaginal delivery and 511 (47%) had a cesarean section. Eighty-seven percent of the women that had a vaginal delivery and 98% of the women having a cesarean section were prescribed antibiotics. The mean number of days on antibiotics in hospital for the women with a vaginal delivery was 3.1 (±1.7) and for the women with cesarean section was 6.0 (±2.5). Twenty-eight percent of both the women with vaginal deliveries and the women with cesarean sections were prescribed antibiotics at discharge. The most commonly prescribed antibiotic group in the hospital for both the women that had a vaginal delivery and the women that had a cesarean section were third-generation cephalosporins (J01DD). The total number of defined daily doses (DDD) per100 bed days for women that had a vaginal delivery was 101, and 127 for women that had a cesarean section. The high percentage of women having had a vaginal delivery that received antibiotics and the deviation from recommendation for cesarean section in the hospital is a cause of concern. Improved maternal health and rational use of antibiotics are

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

Directory of Open Access Journals (Sweden)

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.

Decentralisation in Uganda: Prospects for Improved Service Delivery

African Journals Online (AJOL)

Financial decentralisation, on the other hand, attempted to assign responsibilities and taxes between the centre and local governments, to enable the transfer of grants and other resources to different parts of the country, and to improve service delivery. This paper will review different government, public and academic ...

Synthetic Lipoproteins as Carriers for Drug Delivery.

Science.gov (United States)

Huang, Gangliang; Liu, Yang; Huang, Hualiang

2016-01-01

Synthetic lipoprotein is an effective carrier of targeted delivery for drugs. It has the very small size, good biocompatibility, suitable half-life, and specific lipoprotein receptorbinding capacity. Compared with the traditional natural lipoprotein, synthetic lipoprotein not only retains the original biological characteristics and functions, but also exhibits the excellent characteristics in drug delivery. Herein, the advantages, development, applications, and prospect of synthetic lipoproteins as drug carriers were summarized.

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

Synthetic sustained gene delivery systems.

Science.gov (United States)

Agarwal, Ankit; Mallapragada, Surya K

2008-01-01

Gene therapy today is hampered by the need of a safe and efficient gene delivery system that can provide a sustained therapeutic effect without cytotoxicity or unwanted immune responses. Bolus gene delivery in solution results in the loss of delivered factors via lymphatic system and may cause undesired effects by the escape of bioactive molecules to distant sites. Controlled gene delivery systems, acting as localized depot of genes, provide an extended sustained release of genes, giving prolonged maintenance of the therapeutic level of encoded proteins. They also limit the DNA degradation in the nuclease rich extra-cellular environment. While attempts have been made to adapt existing controlled drug delivery technologies, more novel approaches are being investigated for controlled gene delivery. DNA encapsulated in nano/micro spheres of polymers have been administered systemically/orally to be taken up by the targeted tissues and provide sustained release once internalized. Alternatively, DNA entrapped in hydrogels or scaffolds have been injected/implanted in tissues/cavities as platforms for gene delivery. The present review examines these different modalities for sustained delivery of viral and non-viral gene-delivery vectors. Design parameters and release mechanisms of different systems made with synthetic or natural polymers are presented along with their prospective applications and opportunities for continuous development.

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

Directory of Open Access Journals (Sweden)

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.

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

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.

Online versus Live Delivery of Education to Pharmacists in a Large Multicentre Health Region: A Non-inferiority Assessment of Learning Outcomes.

Science.gov (United States)

Taylor, Robert; Jung, Joanne; Loewen, Peter; Spencer, Carrie; Dossa, Anar; de Lemos, Jane

2013-07-01

The prevalence of online modules for continuing education in the health professions has been increasing in recent years. However, the effectiveness of online modules for pharmacist learning has not been thoroughly studied. The primary aim of this study was to determine if providing education to pharmacists through a self-paced enhanced online module was non-inferior to a face-to-face learning module with respect to knowledge application on the topic of postoperative insulin dosing. Secondary aims were to determine pharmacists' knowledge gain and retention, as well as their satisfaction with the modules. The participants in this prospective, randomized, parallel-group non-inferiority trial were pharmacists in a large multicentre health region. Outcomes were measured by comparing scores obtained on pre- and post-module knowledge-assessment questionnaires. A between-group difference in change on knowledge application scores of less than 25 percentage points was the predetermined non-inferiority margin. A total of 74 pharmacists consented to participate, 38 randomly assigned to use the enhanced online module and 36 to attend the face-to-face learning session. For questions examining knowledge application, the mean improvement achieved by the online learning group was 26 percentage points greater than that achieved by the face-to-face learning group (95% confidence interval [CI] 25 to 27; p online learning group was 7 percentage points less than that achieved by the face-to-face learning group (95% CI 2 to 12; p = 0.008). Therefore, the enhanced online module was deemed to be non-inferior to the face-to-face learning session in terms of knowledge application and knowledge gain. Insufficient data were available to analyze the secondary outcome of knowledge retention over time. Participant satisfaction was similar for the 2 groups (p = 0.62). The self-paced enhanced online module was non-inferior to facilitated face-to-face learning in terms of improving application and

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.

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

Science.gov (United States)

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

2015-03-01

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 study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Stimuli-Responsive Polymeric Systems for Controlled Protein and Peptide Delivery: Future Implications for Ocular Delivery.

Science.gov (United States)

Mahlumba, Pakama; Choonara, Yahya E; Kumar, Pradeep; du Toit, Lisa C; Pillay, Viness

2016-07-30

Therapeutic proteins and peptides have become notable in the drug delivery arena for their compatibility with the human body as well as their high potency. However, their biocompatibility and high potency does not negate the existence of challenges resulting from physicochemical properties of proteins and peptides, including large size, short half-life, capability to provoke immune responses and susceptibility to degradation. Various delivery routes and delivery systems have been utilized to improve bioavailability, patient acceptability and reduce biodegradation. The ocular route remains of great interest, particularly for responsive delivery of macromolecules due to the anatomy and physiology of the eye that makes it a sensitive and complex environment. Research in this field is slowly gaining attention as this could be the breakthrough in ocular drug delivery of macromolecules. This work reviews stimuli-responsive polymeric delivery systems, their use in the delivery of therapeutic proteins and peptides as well as examples of proteins and peptides used in the treatment of ocular disorders. Stimuli reviewed include pH, temperature, enzymes, light, ultrasound and magnetic field. In addition, it discusses the current progress in responsive ocular drug delivery. Furthermore, it explores future prospects in the use of stimuli-responsive polymers for ocular delivery of proteins and peptides. Stimuli-responsive polymers offer great potential in improving the delivery of ocular therapeutics, therefore there is a need to consider them in order to guarantee a local, sustained and ideal delivery of ocular proteins and peptides, evading tissue invasion and systemic side-effects.

Salivary microflora and mode of delivery

DEFF Research Database (Denmark)

Boustedt, Katarina; Roswall, Josefine; Dahlén, Gunnar

2015-01-01

BACKGROUND: Previous cross-sectional studies have suggested that the mode of delivery can influence the composition of oral microflora. The aim of this prospective study was to compare the salivary colonization in vaginally delivered children with children delivered by Caesarian section (C...... months. A saliva sample from the mothers was obtained 6 months after delivery. The parents were asked to complete a questionnaire on socioeconomic factors, lifestyle, and hygiene at baseline and throughout the study period. All samples were analyzed with 13 pre-determined bacterial probes using...

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....

Timing of probiotic milk consumption during pregnancy and effects on the incidence of preeclampsia and preterm delivery: a prospective observational cohort study in Norway

Science.gov (United States)

Nordqvist, Mahsa; Jacobsson, Bo; Brantsæter, Anne-Lise; Myhre, Ronny; Nilsson, Staffan; Sengpiel, Verena

2018-01-01

Objectives To investigate whether the timing of probiotic milk intake before, during early or late pregnancy influences associations with preeclampsia and preterm delivery. Design Population based prospective cohort study. Setting Norway, between 1999 and 2008. Participants 70 149 singleton pregnancies resulting in live-born babies from the Norwegian Mother and Child Cohort Study (no chronic disease, answered questionnaires, no placenta previa/cerclage/serious malformation of fetus, first enrolment pregnancy). Only nulliparous women (n=37 050) were included in the preeclampsia analysis. Both iatrogenic and spontaneous preterm delivery (between gestational weeks 22+0 and 36+6) with spontaneous term controls (between gestational weeks 39+0 and 40+6) were included in the preterm delivery analysis resulting in 34 458 cases. Main outcome measures Adjusted OR for preeclampsia and preterm delivery according to consumption of probiotic milk at three different time periods (before pregnancy, during early and late pregnancy). Results Probiotic milk intake in late pregnancy (but not before or in early pregnancy) was significantly associated with lower preeclampsia risk (adjusted OR: 0.80 (95% CI 0.68 to 0.94) p-value: 0.007). Probiotic intake during early (but not before or during late pregnancy) was significantly associated with lower risk of preterm delivery (adjusted OR: 0.79 (0.64 to 0.97) p-value: 0.03). Conclusions In this observational study, we found an association between timing of probiotic milk consumption during pregnancy and the incidence of the adverse pregnancy outcomes preeclampsia and preterm delivery. If future randomised controlled trials could establish a causal association between probiotics consumption and reduced risk of preeclampsia and preterm delivery, recommending probiotics would be a promising public health measure to reduce these adverse pregnancy outcomes. PMID:29362253

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.

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.

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.

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.

Constraints, challenges and prospects of public-private partnership in health-care delivery in a developing economy.

Science.gov (United States)

Anyaehie, Usb; Nwakoby, Ban; Chikwendu, C; Dim, Cc; Uguru, N; Oluka, Cpi; Ogugua, C

2014-01-01

In Nigeria, concerns on the quality and financing of health-care delivery especially in the public sector have initiated reforms including support for public-private partnerships (PPP) at the Federal Ministry of Health. Likewise, Enugu State has developed a draft policy on PPP since 2005. However, non-validation and non-implementation of this policy might have led to loss of interest in the partnership. The aim of this study was to provide evidence for planning the implementation of PPP in Enugu State health system via a multi-sectoral identification of challenges, constraints and prospects. Pre-tested questionnaires were administered to 466 respondents (251 health workers and 215 community members), selected by multi-stage sampling method from nine Local Government Areas of Enugu State, Nigeria, over a study period of April 2011 to September 2011. Data from the questionnaires were collated manually and quantitative data analyzed using SPSS version 15 (Chicago, IL, USA). Only 159 (34.1%, 159/466) of all respondents actually understood the meaning of PPP though 251 (53.9%) of them had claimed knowledge of the concept. This actual understanding was higher among health workers (57.8%, 145/251) when compared with the community members (6.5%, 14/215) (P < 0.001). Post-PPP enlightenment reviews showed a more desire for PPP implementation among private health-care workers (89.4%, 101/113) and community leaders/members (55.4%, 119/215). PPP in health-care delivery in Enugu State is feasible with massive awareness, elaborate stakeholder's engagements and well-structured policy before implementation. A critical challenge will be to convince the public sector workers who are the anticipated partners to accept and support private sector participation.

A prospective observational study of early fetal growth velocity and its association with birth weight, gestational age at delivery, preeclampsia, and perinatal mortality

Energy Technology Data Exchange (ETDEWEB)

Vasudeva, Akhila, E-mail: akhilavasudeva@gmail.com [Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal University, Manipal 576104, Karnataka State (India); Abraham, Anu Annie, E-mail: anuannieabraham@yahoo.com [Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal University, Manipal 576104, Karnataka State (India); Kamath, Asha, E-mail: aashakamat@gmail.com [Department of Community Medicine, Kasturba Medical College, Manipal, A Constituent College of Manipal University (India)

2013-08-15

Objectives: We aimed to measure early fetal growth velocity and to correlate this with the birth weight, gestational age at delivery, and with the incidence of adverse pregnancy outcomes specifically preeclampsia and perinatal mortality. Methods: A data based prospective observational study, wherein sonographic biometry data and specific pregnancy outcome related data were collected from pregnant women's records, starting soon after their first antenatal visit. Early fetal growth velocity was measured using BPD growth between 11 and 14 weeks scan and anomaly scan and standardizing this by Z scoring. Results: Out of 607 fetuses, 41 (6.7%) were slow growing, 531 (87.4%) normally growing, and 35 (5.7%) fast growing (Z scoring <10th{sup ,} 10–90th, and >90th percentiles respectively). As fetal growth velocity increased, the mean birth weight decreased from 2958.7 ± 388.9 (<10th centile), 2742.1 ± 576.6 (10–90th centile), to 2339.3 ± 729.4 (>90th centile); and gestational age at delivery decreased from 38.5 ± 1.3 (<10th centile), 37.5 ± 2.1 (10–90th centile), to 36.4 ± 2.2 (>90th centile), and both these trends were statistically significant (p < 0.001).Faster growing fetuses had a higher risk of preterm delivery(spontaneous + indicated) compared to other 2 groups [OR 4.42 (2.18,8.98)], and slower growing fetuses had a higher risk of postdated deliveries compared to other 2 groups [OR 3.042 (1.44, 6.45)].We found no significant association between early fetal growth velocity and incidence of small for gestational age at birth/low birth weight at term, preeclampsia, and perinatal mortality. Conclusions: Early fetal growth velocity between first and second trimesters, may be one of the important factors influencing ultimate birthweight and gestational age at delivery.

A prospective observational study of early fetal growth velocity and its association with birth weight, gestational age at delivery, preeclampsia, and perinatal mortality

International Nuclear Information System (INIS)

Vasudeva, Akhila; Abraham, Anu Annie; Kamath, Asha

2013-01-01

Objectives: We aimed to measure early fetal growth velocity and to correlate this with the birth weight, gestational age at delivery, and with the incidence of adverse pregnancy outcomes specifically preeclampsia and perinatal mortality. Methods: A data based prospective observational study, wherein sonographic biometry data and specific pregnancy outcome related data were collected from pregnant women's records, starting soon after their first antenatal visit. Early fetal growth velocity was measured using BPD growth between 11 and 14 weeks scan and anomaly scan and standardizing this by Z scoring. Results: Out of 607 fetuses, 41 (6.7%) were slow growing, 531 (87.4%) normally growing, and 35 (5.7%) fast growing (Z scoring <10th , 10–90th, and >90th percentiles respectively). As fetal growth velocity increased, the mean birth weight decreased from 2958.7 ± 388.9 (<10th centile), 2742.1 ± 576.6 (10–90th centile), to 2339.3 ± 729.4 (>90th centile); and gestational age at delivery decreased from 38.5 ± 1.3 (<10th centile), 37.5 ± 2.1 (10–90th centile), to 36.4 ± 2.2 (>90th centile), and both these trends were statistically significant (p < 0.001).Faster growing fetuses had a higher risk of preterm delivery(spontaneous + indicated) compared to other 2 groups [OR 4.42 (2.18,8.98)], and slower growing fetuses had a higher risk of postdated deliveries compared to other 2 groups [OR 3.042 (1.44, 6.45)].We found no significant association between early fetal growth velocity and incidence of small for gestational age at birth/low birth weight at term, preeclampsia, and perinatal mortality. Conclusions: Early fetal growth velocity between first and second trimesters, may be one of the important factors influencing ultimate birthweight and gestational age at delivery

Anti-Mullerian hormone levels decline under hormonal suppression: a prospective analysis in fertile women after delivery

Directory of Open Access Journals (Sweden)

Ortner Iris

2011-07-01

Full Text Available Abstract Background AMH's reported stability during periods of hormonal change makes it a practical tool in assessing ovarian reserve. However, AMH declines with age and age-specific cut-offs remain to be established in women with proven fertility. This study aims to determine age-specific ranges of AMH in women with proven fertility. Methods Two hundred-ten fertile women, aged 18-40 years, were prospectively recruited for AMH measurements within 14 days after delivery and age stratified into 3 groups (18-30, 31-36 and 37-40 years. Eligibility required spontaneous conception within a maximal period of six months. Autoimmune diseases, chemotherapy, radiation, ovarian surgery and polycystic ovary syndrome precluded inclusion. Results 95% confidence intervals of AMH declined with advancing female age from 0.9-1.1 to 0.6-0.9 and 0.2-0.4 ng/mL (P Conclusions Like infertile populations, fertile women demonstrate declining AMH with advancing age. Uniformly lower levels than in infertile women suggest that AMH levels do not appear as stable under all hormonal influences as previously reported.

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

Analysis of Market Opportunities for Chinese Private Express Delivery Industry

Science.gov (United States)

Jiang, Changbing; Bai, Lijun; Tong, Xiaoqing

China's express delivery market has become the arena in which each express enterprise struggles to chase due to the huge potential demand and high profitable prospects. So certain qualitative and quantitative forecast for the future changes of China's express delivery market will help enterprises understand various types of market conditions and social changes in demand and adjust business activities to enhance their competitiveness timely. The development of China's express delivery industry is first introduced in this chapter. Then the theoretical basis of the regression model is overviewed. We also predict the demand trends of China's express delivery market by using Pearson correlation analysis and regression analysis from qualitative and quantitative aspects, respectively. Finally, we draw some conclusions and recommendations for China's express delivery industry.

[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.

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.

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.

The role of gestational diabetes, pre-pregnancy body mass index and gestational weight gain on the risk of newborn macrosomia: results from a prospective multicentre study.

Science.gov (United States)

Alberico, Salvatore; Montico, Marcella; Barresi, Valentina; Monasta, Lorenzo; Businelli, Caterina; Soini, Valentina; Erenbourg, Anna; Ronfani, Luca; Maso, Gianpaolo

2014-01-15

It is crucial to identify in large population samples the most important determinants of excessive fetal growth. The aim of the study was to evaluate the independent role of pre-pregnancy body mass index (BMI), gestational weight gain and gestational diabetes on the risk of macrosomia. A prospective study collected data on mode of delivery and maternal/neonatal outcomes in eleven Hospitals in Italy. Multiple pregnancies and preterm deliveries were excluded. The sample included 14109 women with complete records. Associations between exposure variables and newborn macrosomia were analyzed using Pearson's chi squared test. Multiple logistic regression models were built to assess the independent association between potential predictors and macrosomia. Maternal obesity (adjusted OR 1.7, 95% CI 1.4-2.2), excessive gestational weight gain (adjusted OR 1.9, 95% CI 1.6-2.2) and diabetes (adjusted OR 2.1, 95% CI 1.5-3.0 for gestational; adjusted OR 3.0, 95% CI 1.2-7.6 for pre-gestational) resulted to be independent predictors of macrosomia, when adjusted for other recognized risk factors. Since no significant interaction was found between pre-gestational BMI and gestational weight gain, excessive weight gain should be considered an independent risk factor for macrosomia. In the sub-group of women affected by gestational or pre-gestational diabetes, pre-gestational BMI was not significantly associated to macrosomia, while excessive pregnancy weight gain, maternal height and gestational age at delivery were significantly associated. In this sub-population, pregnancy weight gain less than recommended was not significantly associated to a reduction in macrosomia. Our findings indicate that maternal obesity, gestational weight gain excess and diabetes should be considered as independent risk factors for newborn macrosomia. To adequately evaluate the clinical evolution of pregnancy all three variables need to be carefully assessed and monitored.

Cohort profile: maternal lifestyle and diet in relation to pregnancy, postpartum and infant health outcomes in Vietnam: A multicentre prospective cohort study.

Science.gov (United States)

Nguyen, Cong Luat; Nguyen, Phung Thi Hoang; Chu, Tan Khac; Ha, Anh Vo Van; Pham, Ngoc Minh; Duong, Dat Van; Do, Dung Van; Tang, Hong Kim; Binns, Colin W; Lee, Andy H

2017-09-05

To determine modifiable maternal risk factors for adverse pregnancy, postpartum maternal and child health outcomes in Vietnam. This prospective cohort study included pregnant women seeking prenatal care at six hospitals in three large cities in Vietnam. After enrolment, eligible participants who gave their consent to participate in the study were interviewed at 24-28 weeks' gestation. Glucose testing was conducted and blood pressure was measured during this period. Each participant will be assessed prospectively during their postnatal visits at delivery, 1, 3, 6, 12, 18 and 24 months, and will be followed up for 5 years. Of 2248 eligible pregnant women, 2030 were recruited (participation rate 90.3%) between August 2015 and July 2016. All participants completed the baseline assessment. Their mean (SD) age was 27.6 (5.3) years. The mean pre-pregnancy body mass index (BMI) was 20.2 (SD 2.6) kg/m 2 , with nearly two-thirds of participants having a normal pre-pregnancy BMI (18.5 to pregnancy BMI pregnancy BMI ≥23.0 kg/m 2 ) accounted for 12.8%. No pregnant women reported smoking during their pregnancy while 13.4% of them had continued drinking. 22.8% of participants had hyperglycaemia. Their mean systolic blood pressure was 105.6 (SD 8.2) mm Hg, and diastolic blood pressure was 67.4 (SD 7.5) mm Hg. The relationships of maternal lifestyle and nutritional status with the health outcomes of pregnancy, postpartum maternity and infants will be analysed. Meanwhile, participants will be closely tracked to minimise loss to follow-up. © 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.

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.

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.

[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.)

Folic acid supplementation, dietary folate intake during pregnancy and risk for spontaneous preterm delivery: a prospective observational cohort study.

Science.gov (United States)

Sengpiel, Verena; Bacelis, Jonas; Myhre, Ronny; Myking, Solveig; Devold Pay, Aase Serine; Haugen, Margaretha; Brantsæter, Anne-Lise; Meltzer, Helle Margrete; Nilsen, Roy Miodini; Magnus, Per; Vollset, Stein Emil; Nilsson, Staffan; Jacobsson, Bo

2014-11-02

Health authorities in numerous countries recommend periconceptional folic acid supplementation to prevent neural tube defects. The objective of this study was to examine the association of dietary folate intake and folic acid supplementation during different periods of pregnancy with the risk of spontaneous preterm delivery (PTD). The Norwegian Mother and Child Cohort Study is a population-based prospective cohort study. A total of 66,014 women with singleton pregnancies resulting in live births in 2002-2009 were included. Folic acid supplementation was self-reported from 26 weeks before pregnancy until pregnancy week 24. At gestational week 22, the women completed a food frequency questionnaire, which allowed the calculation of their average total folate intake from foods and supplements for the first 4-5 months of pregnancy. Spontaneous PTD was defined as the spontaneous onset of delivery between weeks 22+0 and 36+6 (n = 1,755). The median total folate intake was 313 μg/d (interquartile range IQR 167-558) in the overall population and 530 μg/d (IQR 355-636) in the supplement users. Eighty-five percent reported any folic acid supplementation from effect of dietary folate intake or folic acid supplementation on spontaneous PTD. Preconceptional folic acid supplementation starting more than 8 weeks before conception was associated with an increased risk of spontaneous PTD. These results require further investigation before discussing an expansion of folic acid supplementation guidelines.

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

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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.

INTERPOLYELECTROLYTE COMPLEXES AS PROSPECTIVE CARRIERS FOR CONTROLLED DRUG DELIVERY

OpenAIRE

Kaur Jasmeet; Harikumar S.L.; Kaur Amanpreet

2012-01-01

In the current scenario, polymers as carriers have revolutionized the drug delivery system. A more successful approach, to exploit the different properties of polymers in a solitary system is the complexation of polymers to form polyelectrolyte complexes. These complexes circumvent the use of chemical crosslinking agents, thereby reducing the risk of toxicity. The complex formed is generally applied in different dosage forms for the formulation of stable aggregated macromolecules. There are t...

Correlation between Kind of Delivery and Posttraumatic Stress ...

African Journals Online (AJOL)

Background: Posttraumatic stress disorder (PTSD) is a very common mental condition and a unique anxiety disorder. Aim: The present study tried to examine the correlation between kind of delivery and PTSD. Subjects and Methods: This prospective study evaluated 240 Iranian female residents of Tehran, Iran, during the ...

Longitudinal Changes in the Macronutrient Contents of Breast Milk in the Mothers with Preterm Delivery

OpenAIRE

Farid Aleali; minoo fallahi; Mohammad Kazemian; Seyyed Hossein Fakhraee; Abolfazl Afjeh

2018-01-01

Background: Contents of breast milk may change during the first weeks after childbirth, especially in preterm deliveries. The present study aimed to determine the macronutrient contents of breast milk in the mothers with preterm delivery. Methods: This prospective-descriptive study was conducted in Mahdieh Hospital in Tehran, Iran in 2015. Participants included the mothers with preterm delivery, whose infants had a gestational age of

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�

[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.

One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study.

Science.gov (United States)

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

2013-05-01

The study aimed to evaluate 1-year outcomes of the multicentre PREVAIL transapical (TA) study of TA-aortic valve implantation (AVI) in high-risk patients. From September 2009 to August 2010, a total of 150 patients, aged 81.6 ± 5.8 years, 40.7% female, were included at 12 European TA-AVI experienced sites. Patients received 23 (n = 36), 26 (n = 57) and 29 mm (n = 57) second-generation SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) valves. The mean logistic EuroSCORE was 24.3 ± 7.0, and mean Society Thoracic Surgeons score was 7.5 ± 4.4%. Survival was 91.3% at 30 days and 77.9% at 1 year. Subgroup analysis revealed survivals of 91.7/88.9, 86.0/70.2, 96.55/91.2% for patients receiving 23-, 26- and 29-mm valves at 30 days and at 1 year, respectively. Transthoracic echocardiography revealed preserved left ventricular ejection fraction and low gradients. Aortic incompetence was none in 41/48, trace 30/36, mild 22/12 and moderate in 7/4% at discharge and 1 year. Walking distance increased from 221 (postimplant) to 284 m (at 1 year, P = 0.0004). Three patients required reoperation due to increasing aortic incompetence during follow-up. Causes of mortality at 1 year were cardiac (n = 7), stroke (n = 1) and others (n = 5). The European PREVAIL multicentre trial demonstrates good functionality and good outcomes for TA-AVI using the second-generation SAPIEN XT prosthesis and the ASCENDRA-II delivery system. The 29-mm SAPIEN XT valve was successfully introduced and showed excellent results.

Mode of anaesthesia for preterm Caesarean delivery: secondary analysis from the Maternal-Fetal Medicine Units Network Caesarean Registry.

Science.gov (United States)

Butwick, A J; El-Sayed, Y Y; Blumenfeld, Y J; Osmundson, S S; Weiniger, C F

2015-08-01

Preterm delivery is often performed by Caesarean section. We investigated modes of anaesthesia and risk factors for general anaesthesia among women undergoing preterm Caesarean delivery. Women undergoing Caesarean delivery between 24(+0) and 36(+6) weeks' gestation were identified from a multicentre US registry. The mode of anaesthesia was classified as neuraxial anaesthesia (spinal, epidural, or combined spinal and epidural) or general anaesthesia. Logistic regression was used to identify patient characteristic, obstetric, and peripartum risk factors associated with general anaesthesia. Within the study cohort, 11 539 women had preterm Caesarean delivery; 9510 (82.4%) underwent neuraxial anaesthesia and 2029 (17.6%) general anaesthesia. In our multivariate model, African-American race [adjusted odds ratio (aOR)=1.9; 95% confidence interval (CI)=1.7-2.2], Hispanic ethnicity (aOR=1.5; 95% CI=1.2-1.8), other race (aOR=1.4; 95% CI=1.1-1.9), and haemolysis, elevated liver enzymes and low platelets (HELLP) syndrome or eclampsia (aOR=2.8; 95% CI=2.2-3.5) were independently associated with receiving general anaesthesia for preterm Caesarean delivery. Women with an emergency Caesarean delivery indication had the highest odds for general anaesthesia (aOR=3.5; 95% CI=3.1-3.9). For every 1 week decrease in gestational age at delivery, the adjusted odds of general anaesthesia increased by 13%. In our study cohort, nearly one in five women received general anaesthesia for preterm Caesarean delivery. Although potential confounding by unmeasured factors cannot be excluded, our findings suggest that early gestational age at delivery, emergent Caesarean delivery indications, hypertensive disease, and non-Caucasian race or ethnicity are associated with general anaesthesia for preterm Caesarean delivery. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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.

Effect of thoracic epidural anesthesia on oxygen delivery and utilization in cardiac surgical patients scheduled to undergo off-pump coronary artery bypass surgery: a prospective study.

Science.gov (United States)

Suryaprakash, Sharadaprasad; Chakravarthy, Murali; Gautam, Mamatha; Gandhi, Anurag; Jawali, Vivek; Patil, Thimmannagowda; Jayaprakash, Krishnamoorthy; Pandey, Saurabh; Muniraju, Geetha

2011-01-01

To evaluate the effect of thoracic epidural anesthesia (TEA) on tissue oxygen delivery and utilization in patients undergoing cardiac surgery. This prospective observational study was conducted in a tertiary referral heart hospital. A total of 25 patients undergoing elective off-pump coronary artery bypass surgery were enrolled in this study. All patients received thoracic epidural catheter in the most prominent inter-vertebral space between C7 and T3 on the day before operation. On the day of surgery, an arterial catheter and Swan Ganz catheter (capable of measuring cardiac index) was inserted. After administering full dose of local anesthetic in the epidural space, serial hemodynamic and oxygen transport parameters were measured for 30 minute prior to administration of general anesthesia, with which the study was culminated. A significant decrease in oxygen delivery index with insignificant changes in oxygen extraction and consumption indices was observed. We conclude that TEA does not affect tissue oxygenation despite a decrease in arterial pressures and cardiac output.

Effect of thoracic epidural anesthesia on oxygen delivery and utilization in cardiac surgical patients scheduled to undergo off-pump coronary artery bypass surgery: A prospective study

Directory of Open Access Journals (Sweden)

Suryaprakash Sharadaprasad

2011-01-01

Full Text Available To evaluate the effect of thoracic epidural anesthesia (TEA on tissue oxygen delivery and utilization in patients undergoing cardiac surgery. This prospective observational study was conducted in a tertiary referral heart hospital. A total of 25 patients undergoing elective off-pump coronary artery bypass surgery were enrolled in this study. All patients received thoracic epidural catheter in the most prominent inter-vertebral space between C7 and T3 on the day before operation. On the day of surgery, an arterial catheter and Swan Ganz catheter (capable of measuring cardiac index was inserted. After administering full dose of local anesthetic in the epidural space, serial hemodynamic and oxygen transport parameters were measured for 30 minute prior to administration of general anesthesia, with which the study was culminated. A significant decrease in oxygen delivery index with insignificant changes in oxygen extraction and consumption indices was observed. We conclude that TEA does not affect tissue oxygenation despite a decrease in arterial pressures and cardiac output.

Delivery of care to diabetic patients with foot ulcers in daily practice: results of the Eurodiale Study, a prospective cohort study

DEFF Research Database (Denmark)

Prompers, L.; Huijberts, M.; Apelqvist, J.

2008-01-01

Aims To determine current management and to identify patient-related factors and barriers that influence management strategies in diabetic foot disease. Methods The Eurodiale Study is a prospective cohort study of 1232 consecutive individuals presenting with a new diabetic foot ulcer in 14 centres...... suggest that current guidelines are too general and that healthcare organizational barriers and personal beliefs result in underuse of recommended therapies. Action should be undertaken to overcome these barriers and to guarantee the delivery of optimal care for the many individuals with diabetic foot...... across Europe. We determined the use of management strategies: referral, use of offloading, vascular imaging and revascularization. Results Twenty-seven percent of the patients had been treated for > 3 months before referral to a foot clinic. This varied considerably between countries (6-55%). At study...

Description of inter-institutional referrals after admission for labor and delivery: a prospective population based cohort study in rural Maharashtra, India.

Science.gov (United States)

Patel, Archana B; Prakash, Amber Abhijeet; Raynes-Greenow, Camille; Pusdekar, Yamini V; Hibberd, Patricia L

2017-05-19

In 2008, the Indian government introduced financial assistance to encourage health facility deliveries. Facility births have increased, but maternal and neonatal morbidity and mortality have not decreased raising questions about the quality of care provided in facilities and access to a quality referral system. We evaluated the potential role of inter-institutional transfers of women admitted for labor and delivery on adverse maternal and neonatal outcomes in an ongoing prospective, population-based Maternal and Newborn Health Registry in Central India. Pregnant women from 20 rural Primary Health Centers near Nagpur, Maharashtra were followed throughout pregnancy and to day 42 post-partum. Inter- institutional referral was defined as transfer of a woman from a first or second level facility where she was admitted for labor and delivery to facility providing higher level of care, after admission to the day of delivery. Maternal mortality, stillbirth, early and late neonatal mortality were compared in mothers who were and were not referred. Factors associated with inter-institutional referral were analyzed using multivariable models with generalized estimating equations, adjusted for clustering at the level of the Primary Health Center. Between June 2009 and June 2013, 3236 (9.4%) of 34,319 women had inter-institutional referral. Factors associated with referrals were maternal age (adjusted Relative Risk or aRR 1.1; 1.0-1.2); moderate or severe anemia (aRR 1.2; 1.2-1.4), gestational age <37 weeks (aRR 1.16; 1.05-1.27), multiple gestation (aRR 1.6; 1.2-2.1), absent fetal heart rate (aRR 1.7; 1.3-2.2), primigravida (aRR 1.4; 1.3, 1.6), primigravida with any pregnancy related maternal condition such as obstructed or prolonged labor; major antepartum or post-partum hemorrhage, hypertension or preeclampsia and breech, transverse or oblique lie (aRR 4.7; 3.8, 5.8), multigravida with any pregnancy related conditions (aRR 4.2; 3.4-5.2). Stillbirths, early neonatal

Factors During Pregnancy, Delivery and Birth Affecting Global Quality of Life of the Adult Child at Long-term Follow-up. Results from the Prospective Copenhagen Perinatal Birth Cohort 1959-61

Directory of Open Access Journals (Sweden)

Søren Ventegodt

2005-01-01

Full Text Available This paper presents a prospective cohort study, where we explore associations between pregnancy, delivery and the global quality of life (QOL of the adult child 31-33 years later. The data is from the Copenhagen Perinatal Birth Cohort 1959-61 using two sets of questionnaires send to 7,222 persons: one filled out by physicians during pregnancy and delivery, while the follow-up questionnaire was completed by the adult children 31-33 years later. The main outcome measures were objective factors describing pregnancy and delivery along with global quality of life, including: Well-being, life satisfaction, happiness, fulfilment of needs, experience of life's temporal and spatial domains, expression of life's potentials and objective measures. Results showed two main factors in pregnancy that seemed to be associated with a reduced quality of life for the child 31-33 years later: the mother's smoking habits and the mother's medication–especially painkillers and different psychopharmacological drugs with the association being most prevalent early in pregnancy. Considering what can and do go wrong during the various stages of labour and delivery and considering how few connections we found between the factors examined and the later global QOL, it seems that the child is remarkably resilient to external influences during pregnancy and delivery concerned with global QOL, as an adult.

Maternal biomarkers of endothelial dysfunction and preterm delivery.

Directory of Open Access Journals (Sweden)

Xinhua Chen

Full Text Available Endothelial dysfunction is key to the development of atherosclerosis. Preterm delivery foreshadows later maternal cardiovascular disease (CVD, but it is not known if endothelial dysfunction also occurs. We prospectively measured circulating biomarkers of endothelial dysfunction in pregnant women with preterm or term delivery.We conducted a case-control study nested within a large prospective epidemiological study of young, generally healthy pregnant women. Women who delivered preterm (<37 completed weeks gestation, n = 240 and controls who delivered at term (n = 439 were included. Pregnancies complicated by preeclampsia were analyzed separately. Circulating endothelial dysfunction biomarkers included soluble intercellular adhesion molecule-1 (sICAM-1, vascular cell adhesion molecule-1 (sVCAM-1 and soluble E-selectin (sE-selectin.Elevated levels of sICAM-1 and sVCAM-1 were positively associated with preterm delivery independent of usual risk factors. At entry (∼16 wks, the adjusted odds ratio (AOR was 1.73 (95% confidence interval (CI 1.09-2.74 for the highest quartile of sICAM-1 versus the lowest quartile and for sVCAM-1 the AOR was 2.17 (95% CI 1.36-3.46. When analysis was limited to cases with a spontaneous preterm delivery, the results were unchanged. Similar results were obtained for the 3rd trimester (∼30 wks. Elevated sE-selectin was increased only in preterm delivery complicated by preeclampsia; risk was increased at entry (AOR 2.32, 95% CI 1.22-4.40 and in the 3rd trimester (AOR 3.37, 95% CI 1.78-6.39.Impaired endothelial function as indicated by increased levels of soluble molecules commonly secreted by endothelial cells is a pathogenic precursor to CVD that is also present in women with preterm delivery. Our findings underscore the need for follow-up studies to determine if improving endothelial function prevents later CVD risk in women.

Outcomes of Operative Vaginal Delivery during Trial of Labor after Cesarean Delivery.

Science.gov (United States)

Brock, Clifton O; Govindappagari, Shravya; Gyamfi-Bannerman, Cynthia

2017-07-01

Objective  The objective of this study is to determine the maternal and neonatal morbidity associated with attempting operative vaginal delivery (OVD) compared with the alternative of a laboring repeat cesarean delivery (LRCD) in women attempting a trial of labor after cesarean delivery (TOLAC). Methods  This is a secondary analysis of a multicenter prospective study designed to assess perinatal outcomes of OVD in women with a prior uterine scar. The study includes women who attempted TOLAC and reached +2 station with a fully dilated cervix. Composites on neonatal and maternal morbidity were compared between women in whom OVD was attempted and those who underwent LRCD by fitting multivariate logistic regression models. Results  In total, 6,489 women attempting TOLAC reached 2+ station with a fully dilated cervix. Of these, 5,640 (86.9%) had a spontaneous vaginal delivery, 762 (11.7%) underwent attempted OVD, and 87 (1.3%) had an LRCD. Compared with attempting OVD, LRCD was associated with greater neonatal morbidity (odds ratio [OR]: 2.41; 95% confidence interval [CI]: 1.13-5.15) and less maternal morbidity (OR: 0.28; 95% CI: 0.14-0.55). Maternal morbidity of OVD is driven by perineal injury. Conclusion  In laboring women with a previous uterine scar, attempting OVD is associated with greater maternal and less neonatal morbidity than LRCD. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Effects of carrying a pregnancy and of method of delivery on urinary incontinence: a prospective cohort study

Directory of Open Access Journals (Sweden)

Mondor Myrto

2004-02-01

Full Text Available Abstract Background This study was carried out to identify risk factors associated with urinary incontinence in women three months after giving birth. Methods Urinary incontinence before and during pregnancy was assessed at study enrolment early in the third trimester. Incontinence was re-assessed three months postpartum. Logistic regression analysis was used to assess the role of maternal and obstetric factors in causing postpartum urinary incontinence. This prospective cohort study in 949 pregnant women in Quebec, Canada was nested within a randomised controlled trial of prenatal perineal massage. Results Postpartum urinary incontinence was increased with prepregnancy incontinence (adjusted odds ratio [adj0R] 6.44, 95% CI 4.15, 9.98, incontinence beginning during pregnancy (adjOR 1.93, 95% CI 1.32, 2.83, and higher prepregnancy body mass index (adjOR 1.07/unit of BMI, 95% CI 1.03,1.11. Caesarean section was highly protective (adjOR 0.27, 95% CI 0.14, 0.50. While there was a trend towards increasing incontinence with forceps delivery (adjOR 1.73, 95% CI 0.96, 3.13 this was not statistically significant. The weight of the baby, episiotomy, the length of the second stage of labour, and epidural analgesia were not predictive of urinary incontinence. Nor was prenatal perineal massage, the randomised controlled trial intervention. When the analysis was limited to women having their first vaginal birth, the same risk factors were important, with similar adjusted odds ratios. Conclusions Urinary incontinence during pregnancy is extremely common, affecting over half of pregnant women. Urinary incontinence beginning during pregnancy roughly doubles the likelihood of urinary incontinence at 3 months postpartum, regardless whether delivery is vaginal or by Caesarean section.

Does alcohol increase the risk of preterm delivery?

DEFF Research Database (Denmark)

Kesmodel, Ulrik; Olsen, Sjúrður Fróði; Secher, Niels Jørgen

2000-01-01

We evaluated the association between alcohol intake during pregnancy and preterm delivery. Women attending routine antenatal care at Aarhus University Hospital, Denmark, from 1989–1991 and 1992–1996 were eligible. We included 18,228 singleton pregnancies in the analyses. We obtained prospective...... information on alcohol intake at 16 and 30 weeks of gestation, other lifestyle factors, maternal characteristics, and obstetrical risk factors from self-administered questionnaires and hospital files. For women with alcohol intake of 1–2, 3–4, 5–9, and >=10 drinks/week the risk ratio (RR) of preterm delivery...

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

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

Science.gov (United States)

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.

Event-related EEG responses to anticipation and delivery of monetary and social reward.

Science.gov (United States)

Flores, Amanda; Münte, Thomas F; Doñamayor, Nuria

2015-07-01

Monetary and a social incentive delay tasks were used to characterize reward anticipation and delivery with electroencephalography. During reward anticipation, N1, P2 and P3 components were modulated by both prospective reward value and incentive type (monetary or social), suggesting distinctive allocation of attentional and motivational resources depending not only on whether rewards or non-rewards were cued, but also on the monetary and social nature of the prospective outcomes. In the delivery phase, P2, FRN and P3 components were also modulated by levels of reward value and incentive type, illustrating how distinctive affective and cognitive processes were attached to the different outcomes. Our findings imply that neural processing of both reward anticipation and delivery can be specific to incentive type, which might have implications for basic as well as translational research. These results are discussed in the light of previous electrophysiological and neuroimaging work using similar tasks. Copyright © 2015 Elsevier B.V. All rights reserved.

Nursing informatics education and use: challenges and prospects in ...

African Journals Online (AJOL)

Nursing informatics education and use: challenges and prospects in Nigeria. ... that training in NI is critical in the delivery of safe and quality patient care. ... Director of Nursing Services and Principals as well as Nursing associations like ...

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...

The outcome of a multi-centre feasibility study of online adaptive radiotherapy for muscle-invasive bladder cancer TROG 10.01 BOLART

International Nuclear Information System (INIS)

Foroudi, Farshad; Pham, Daniel; Rolfo, Aldo; Bressel, Mathias; Tang, Colin I.; Tan, Alex; Turner, Sandra; Hruby, George; Williams, Stephen; Hayne, Dickon; Lehman, Margot; Skala, Marketa; Jose, Chakiath C.; Gogna, Kumar; Kron, Tomas

2014-01-01

Purpose: To assess whether online adaptive radiotherapy for bladder cancer is feasible across multiple Radiation Oncology departments using different imaging, delivery and recording technology. Materials and methods: A multi-centre feasibility study of online adaptive radiotherapy, using a choice of three “plan of the day”, was conducted at 12 departments. Patients with muscle-invasive bladder cancer were included. Departments were activated if part of the pilot study or after a site-credentialing visit. There was real time review of the first two cases from each department. Results: 54 patients were recruited, with 50 proceeding to radiotherapy. There were 43 males and 7 females with a mean age of 78 years. The tumour stages treated included T1 (1 patient), T2 (35), T3 (10) and T4 (4). One patient died of an unrelated cause during radiotherapy. The three adaptive plans were created before the 10th fraction in all cases. In 8 (16%) of the patients, a conventional plan using a ‘standard’ CTV to PTV margin of 1.5 cm was used for one or more fractions where the pre-treatment bladder CTV was larger than any of the three adaptive plans. The bladder CTV extended beyond the PTV on post treatment imaging in 9 (18%) of the 49 patients. Conclusions: From a technical perspective an online adaptive radiotherapy technique can be instituted in a multi-centre setting. However, without further bladder filling control or imaging, a CTV to PTV margin of 7 mm is insufficient

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.

Loss to follow-up in an international, multicentre observational study

DEFF Research Database (Denmark)

Mocroft, A; Kirk, O; Aldins, P

2008-01-01

OBJECTIVE: The aim of this work was to assess loss to follow-up (LTFU) in EuroSIDA, an international multicentre observational cohort study. METHODS: LTFU was defined as no follow-up visit, CD4 cell count measurement or viral load measurement after 1 January 2006. Poisson regression was used...

A Multicentre Study of Thromboprophylaxis in Pregnancy

LENUS (Irish Health Repository)

Crowley, MP

2017-05-01

Venous thromboembolism (VTE) is a leading cause of maternal mortality. The risk increases with increasing maternal age, mode of delivery and medical co-morbidities. Thromboprophylaxis with low molecular weight heparin (LMWH) has been shown to be both safe and efficacious. The aim of this study was to prospectively investigate the incidence of maternal risk factors in pregnant women admitted to hospital, to calculate their VTE risk status and to investigate if they were receiving appropriate thromboprophylaxis. All patients admitted to the participating hospitals on the day of investigation were assessed for risk of VTE on the basis of hospital chart review. Five Hundred and forty women were recruited from 16 hospitals. Almost 32% (31.7%) were receiving thromboprophylaxis with LMWH. Just under 80% of patients were on the correct thromboprophylaxis strategy as defined by the RCOG guideline but 49% were under-dosed. The odds of receiving appropriate thromboprophylaxis were significantly increased if the woman was >35 years 0or with parity>3.

Antenatal care service quality increases the odds of utilizing institutional delivery in Bahir Dar city administration, North Western Ethiopia: A prospective follow up study.

Science.gov (United States)

Ejigu Tafere, Tadese; Afework, Mesganaw Fanthahun; Yalew, Alemayehu Worku

2018-01-01

In Ethiopia, more than 62% of pregnant women attend antenatal care at least once, yet only about one in four women give birth at health facility. This gap has fueled the need to investigate on the quality of ANC services at public health facilities and its link with the use of institutional delivery. To assess the linkage between ANC quality and the use of institutional delivery among pregnant women attending ANC at public health facilities of BDR City Administration. A facility based prospective follow up study was conducted. and nine hundred seventy pregnant women with gestational age ≤ 16 weeks who came for their first ANC visit were enrolled.Women were followed from their first ANC visit until delivery. Longitudinal data was collected during consultation with ANC providers using structured observation checklist. ANC service was considered as acceptable quality if women received ≥75th percentile of the essential ANC services. Generalized Estimating Equation (GEE) was carried out to control cluster effect among women who received ANC in the same facility. Among 823 pregnant women who completed follow up, only about one third (27.6%) received acceptable quality of ANC services. In one health facility syphilis test was not done at all for the last two years. The odds of giving birth at health institution among pregnant women who received acceptable ANC quality service was about 3.38 times higher than among pregnant women who received unacceptable ANC quality service (AOR = 3.38, 95% CI: 1.67, 6.83). In this study the quality of ANC service provision in public health facilities was compromised/low. Provision of quality ANC service had a great role in promoting institutional delivery. Therefore the local authorities at each level of health sector or the nongovernmental organizations working to improve maternal health need to provide training on focused antenatal care protocol for ANC providers.

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

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.

Ultrasound-mediated drug delivery to the brain: principles, progress and prospects

NARCIS (Netherlands)

Dasgupta, I.; Liu, M.; Ojha, T.; Storm, Gerrit; Kiessling, F.; Lammers, Twan Gerardus Gertudis Maria

2016-01-01

The blood–brain barrier (BBB) limits drug delivery to the central nervous system. When combined with microbubbles, ultrasound can transiently permeate blood vessels in the brain. This approach, which can be referred to as sonoporation or sonopermeabilization, holds significant promise for shuttling

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

Science.gov (United States)

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

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.

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.

Coping strategies for postpartum depression: a multi-centric study of 1626 women.

Science.gov (United States)

Gutiérrez-Zotes, Alfonso; Labad, Javier; Martín-Santos, Rocío; García-Esteve, Luisa; Gelabert, Estel; Jover, Manuel; Guillamat, Roser; Mayoral, Fermín; Gornemann, Isolde; Canellas, Francesca; Gratacós, Mónica; Guitart, Montserrat; Roca, Miguel; Costas, Javier; Ivorra, Jose Luis; Navinés, Ricard; de Diego-Otero, Yolanda; Vilella, Elisabet; Sanjuan, Julio

2016-06-01

The transition to motherhood is stressful as it requires several important changes in family dynamics, finances, and working life, along with physical and psychological adjustments. This study aimed at determining whether some forms of coping might predict postpartum depressive symptomatology. A total of 1626 pregnant women participated in a multi-centric longitudinal study. Different evaluations were performed 8 and 32 weeks after delivery. Depression was assessed using the Edinburgh Postnatal Depression Scale (EPDS) and the structured Diagnostic Interview for Genetic Studies (DIGS). The brief Coping Orientation for Problem Experiences (COPE) scale was used to measure coping strategies 2-3 days postpartum. Some coping strategies differentiate between women with and without postpartum depression. A logistic regression analysis was used to explore the relationships between the predictors of coping strategies and major depression (according to DSM-IV criteria). In this model, the predictor variables during the first 32 weeks were self-distraction (OR 1.18, 95 % CI 1.04-1.33), substance use (OR 0.58, 95 % CI 0.35-0.97), and self-blame (OR 1.18, 95 % CI 1.04-1.34). In healthy women with no psychiatric history, some passive coping strategies, both cognitive and behavioral, are predictors of depressive symptoms and postpartum depression and help differentiate between patients with and without depression.

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.

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)

Improvement of different vaccine delivery systems for cancer therapy

Directory of Open Access Journals (Sweden)

Safaiyan Shima

2011-01-01

Full Text Available Abstract Cancer vaccines are the promising tools in the hands of the clinical oncologist. Many tumor-associated antigens are excellent targets for immune therapy and vaccine design. Optimally designed cancer vaccines should combine the best tumor antigens with the most effective immunotherapy agents and/or delivery strategies to achieve positive clinical results. Various vaccine delivery systems such as different routes of immunization and physical/chemical delivery methods have been used in cancer therapy with the goal to induce immunity against tumor-associated antigens. Two basic delivery approaches including physical delivery to achieve higher levels of antigen production and formulation with microparticles to target antigen-presenting cells (APCs have demonstrated to be effective in animal models. New developments in vaccine delivery systems will improve the efficiency of clinical trials in the near future. Among them, nanoparticles (NPs such as dendrimers, polymeric NPs, metallic NPs, magnetic NPs and quantum dots have emerged as effective vaccine adjuvants for infectious diseases and cancer therapy. Furthermore, cell-penetrating peptides (CPP have been known as attractive carrier having applications in drug delivery, gene transfer and DNA vaccination. This review will focus on the utilization of different vaccine delivery systems for prevention or treatment of cancer. We will discuss their clinical applications and the future prospects for cancer vaccine development.

Effects of epidural lidocaine analgesia on labor and delivery: A randomized, prospective, controlled trial

Directory of Open Access Journals (Sweden)

Nafisi Shahram

2006-12-01

Full Text Available Abstract Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic. Our study was conducted to answer the question: does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population? Method 395 healthy, nulliparous women, at term, presented in spontaneous labor with a singleton vertex presentation. These patients were randomized to receive analgesia either, epidural with bolus doses of 1% lidocaine or intravenous, with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters. The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded, in each patient. The total number of vacuum-assisted and cesarean deliveries were also measured. Results 197 women were randomized to the epidural group. 198 women were randomized to the single-dose intravenous meperidine group. There was no statistical difference in rates of vacuum-assisted delivery rate. Cesarean deliveries, as a consequence of fetal bradycardia or dystocia, did not differ significantly between the groups. Differences in the duration of the active-first and the second stages of labor were not statistically significant. The number of newborns with 1-min and 5-min Apgar scores less than 7, did not differ significantly between both analgesia groups. Conclusion Epidural analgesia with 1% lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate.

Seventeen Years of Delivery of Open and Distance Education by ...

African Journals Online (AJOL)

Seventeen Years of Delivery of Open and Distance Education by The Open University of Tanzania (OUT) in East Africa and Beyond. ... This has necessitated the abandonment of the old annual confidential review forms used by most east African universities. The paper ends by highlighting the main prospects and ...

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

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.

Enhancing topical analgesic administration: review and prospect for transdermal and transbuccal drug delivery systems.

Science.gov (United States)

Sanz, Roser; Calpena, Ana C; Mallandrich, Mireia; Clares, Beatriz

2015-01-01

Topical administration is an appealing method for drug delivery due to its non-invasiveness, self-controlled application, avoidance of first-pass metabolism in the liver and reduction of systemic side effects compared to other conventional routes such as oral and parenteral. However, topical administration must overcome the permeable barriers that skin and mucosa represent for the drug to achieve its desired therapeutic effect. Penetration of drugs through human skin is mainly impaired by the stratum corneum- the uppermost keratinized skin layer. In contrast, the stratified squamous epithelium (a nonkeratinized tissue) represents the major physical barrier for transbuccal drug administration in humans. Different technologies have been studied to enhance the bioavailability or local effects of drugs administered through skin and buccal mucosa. Those technologies involve the use of physical or chemical enhancers and new dosage forms such as vesicles, cyclodextrins, nanoparticles and other complex systems. Combinations of these technologies may further increase drug delivery in some cases. As analgesia is one of the main therapeutic effects sought through topical administration, this paper focuses on the review of drug delivery systems to improve the topical and transdermal/transbuccal drug delivery of substances with known analgesic action. A discussion of their possibilities and limitations is also included.

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

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.

Critical Assessment of Implantable Drug Delivery Devices in Glaucoma Management

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Dharani Manickavasagam

2013-01-01

Full Text Available Glaucoma is a group of heterogeneous disorders involving progressive optic neuropathy that can culminate into visual impairment and irreversible blindness. Effective therapeutic interventions must address underlying vulnerability of retinal ganglion cells (RGCs to degeneration in conjunction with correcting other associated risk factors (such as elevated intraocular pressure. However, realization of therapeutic outcomes is heavily dependent on suitable delivery system that can overcome myriads of anatomical and physiological barriers to intraocular drug delivery. Development of clinically viable sustained release systems in glaucoma is a widely recognized unmet need. In this regard, implantable delivery systems may relieve the burden of chronic drug administration while potentially ensuring high intraocular drug bioavailability. Presently there are no FDA-approved implantable drug delivery devices for glaucoma even though there are several ongoing clinical studies. The paper critically assessed the prospects of polymeric implantable delivery systems in glaucoma while identifying factors that can dictate (a patient tolerability and acceptance, (b drug stability and drug release profiles, (c therapeutic efficacy, and (d toxicity and biocompatibility. The information gathered could be useful in future research and development efforts on implantable delivery systems in glaucoma.

Intake of probiotic food and risk of spontaneous preterm delivery.

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Myhre, Ronny; Brantsæter, Anne Lise; Myking, Solveig; Gjessing, Håkon Kristian; Sengpiel, Verena; Meltzer, Helle Margrete; Haugen, Margaretha; Jacobsson, Bo

2011-01-01

Preterm delivery represents a substantial problem in perinatal medicine worldwide. Current knowledge on potential influences of probiotics in food on pregnancy complications caused by microbes is limited. We hypothesized that intake of food with probiotics might reduce pregnancy complications caused by pathogenic microorganisms and, through this, reduce the risk of spontaneous preterm delivery. This study was performed in the Norwegian Mother and Child Cohort on the basis of answers to a food-frequency questionnaire. We studied intake of milk-based products containing probiotic lactobacilli and spontaneous preterm delivery by using a prospective cohort study design (n = 950 cases and 17,938 controls) for the pregnancy outcome of spontaneous preterm delivery (delivery were associated with any intake of milk-based probiotic products in an adjusted model [odds ratio (OR): 0.857; 95% CI: 0.741, 0.992]. By categorizing intake into none, low, and high intakes of the milk-based probiotic products, a significant association was observed for high intake (OR: 0.820; 95% CI: 0.681, 0.986). Women who reported habitual intake of probiotic dairy products had a reduced risk of spontaneous preterm delivery.

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

Design of an international multicentre RCT on group schema therapy for borderline personality disorder.

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Wetzelaer, Pim; Farrell, Joan; Evers, Silvia M A A; Jacob, Gitta A; Lee, Christopher W; Brand, Odette; van Breukelen, Gerard; Fassbinder, Eva; Fretwell, Heather; Harper, R Patrick; Lavender, Anna; Lockwood, George; Malogiannis, Ioannis A; Schweiger, Ulrich; Startup, Helen; Stevenson, Teresa; Zarbock, Gerhard; Arntz, Arnoud

2014-11-18

Borderline personality disorder (BPD) is a severe and highly prevalent mental disorder. Schema therapy (ST) has been found effective in the treatment of BPD and is commonly delivered through an individual format. A group format (group schema therapy, GST) has also been developed. GST has been found to speed up and amplify the treatment effects found for individual ST. Delivery in a group format may lead to improved cost-effectiveness. An important question is how GST compares to treatment as usual (TAU) and what format for delivery of schema therapy (format A; intensive group therapy only, or format B; a combination of group and individual therapy) produces the best outcomes. An international, multicentre randomized controlled trial (RCT) will be conducted with a minimum of fourteen participating centres. Each centre will recruit multiple cohorts of at least sixteen patients. GST formats as well as the orders in which they are delivered to successive cohorts will be balanced. Within countries that contribute an uneven number of sites, the orders of GST formats will be balanced within a difference of one. The RCT is designed to include a minimum of 448 patients with BPD. The primary clinical outcome measure will be BPD severity. Secondary clinical outcome measures will include measures of BPD and general psychiatric symptoms, schemas and schema modes, social functioning and quality of life. Furthermore, an economic evaluation that consists of cost-effectiveness and cost-utility analyses will be performed using a societal perspective. Lastly, additional investigations will be carried out that include an assessment of the integrity of GST, a qualitative study on patients' and therapists' experiences with GST, and studies on variables that might influence the effectiveness of GST. This trial will compare GST to TAU for patients with BPD as well as two different formats for the delivery of GST. By combining an evaluation of clinical effectiveness, an economic evaluation

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

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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.

The immediate effect of vaginal and caesarean delivery on anal sphincter measurements.

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Karcaaltincaba, Deniz; Erkaya, Salim; Isik, Hatice; Haberal, Ali

2016-08-01

This study evaluated the effects of vaginal and caesarean delivery on internal and external anal sphincter muscle thickness using translabial ultrasonography (TL-US). This prospective cohort study enrolled nulliparous women who either had vaginal or caesarean deliveries. The thickness of the hypoechoic internal anal sphincter (IAS) and hyperechoic external anal sphincter (EAS) at the 12, 3, 6, and 9 o'clock positions at the distal level were measured before delivery and within 24-48 h after delivery. A total 105 consecutive women were enrolled in the study: 60 in the vaginal delivery group and 45 in the caesarean delivery group. The IAS muscle thickness at the 12 o'clock position in the vaginal delivery group was significantly thicker before compared with after delivery (mean ± SD: 2.31 ± 0.74 mm versus 1.81 ± 0.64 mm, respectively). The EAS muscle thickness at the 12 o'clock position in the vaginal delivery group was significantly thicker before compared with after delivery (mean ± SD: 2.42 ± 0.64 mm versus 1.97 ± 0.85, respectively). There was significant muscle thinning of both the IAS and EAS at the 12 o'clock position after vaginal delivery, but not after caesarean delivery. © The Author(s) 2016.

A high-density lipoprotein-mediated drug delivery system.

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Mo, Zhong-Cheng; Ren, Kun; Liu, Xing; Tang, Zhen-Li; Yi, Guang-Hui

2016-11-15

High-density lipoprotein (HDL) is a comparatively dense and small lipoprotein that can carry lipids as a multifunctional aggregate in plasma. Several studies have shown that increasing the levels or improving the functionality of HDL is a promising target for treating a wide variety of diseases. Among lipoproteins, HDL particles possess unique physicochemical properties, including naturally synthesized physiological components, amphipathic apolipoproteins, lipid-loading and hydrophobic agent-incorporating characteristics, specific protein-protein interactions, heterogeneity, nanoparticles, and smaller size. Recently, the feasibility and superiority of using HDL particles as drug delivery vehicles have been of great interest. In this review, we summarize the structure, constituents, biogenesis, remodeling, and reconstitution of HDL drug delivery systems, focusing on their delivery capability, characteristics, applications, manufacturing, and drug-loading and drug-targeting characteristics. Finally, the future prospects are presented regarding the clinical application and challenges of using HDL as a pharmacodelivery carrier. Copyright © 2016 Elsevier B.V. All rights reserved.

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.

The application of the Ten Group classification system (TGCS in caesarean delivery case mix adjustment. A multicenter prospective study.

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Gianpaolo Maso

Full Text Available BACKGROUND: Caesarean delivery (CD rates are commonly used as an indicator of quality in obstetric care and risk adjustment evaluation is recommended to assess inter-institutional variations. The aim of this study was to evaluate whether the Ten Group classification system (TGCS can be used in case-mix adjustment. METHODS: Standardized data on 15,255 deliveries from 11 different regional centers were prospectively collected. Crude Risk Ratios of CDs were calculated for each center. Two multiple logistic regression models were herein considered by using: Model 1- maternal (age, Body Mass Index, obstetric variables (gestational age, fetal presentation, single or multiple, previous scar, parity, neonatal birth weight and presence of risk factors; Model 2- TGCS either with or without maternal characteristics and presence of risk factors. Receiver Operating Characteristic (ROC curves of the multivariate logistic regression analyses were used to assess the diagnostic accuracy of each model. The null hypothesis that Areas under ROC Curve (AUC were not different from each other was verified with a Chi Square test and post hoc pairwise comparisons by using a Bonferroni correction. RESULTS: Crude evaluation of CD rates showed all centers had significantly higher Risk Ratios than the referent. Both multiple logistic regression models reduced these variations. However the two methods ranked institutions differently: model 1 and model 2 (adjusted for TGCS identified respectively nine and eight centers with significantly higher CD rates than the referent with slightly different AUCs (0.8758 and 0.8929 respectively. In the adjusted model for TGCS and maternal characteristics/presence of risk factors, three centers had CD rates similar to the referent with the best AUC (0.9024. CONCLUSIONS: The TGCS might be considered as a reliable variable to adjust CD rates. The addition of maternal characteristics and risk factors to TGCS substantially increase the

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

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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

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

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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

Prospective study of determinants and costs of home births in Mumbai slums.

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Das, Sushmita; Bapat, Ujwala; More, Neena Shah; Chordhekar, Latika; Joshi, Wasundhara; Osrin, David

2010-07-30

Around 86% of births in Mumbai, India, occur in healthcare institutions, but this aggregate figure hides substantial variation and little is known about urban home births. We aimed to explore factors influencing the choice of home delivery, care practices and costs, and to identify characteristics of women, households and the environment which might increase the likelihood of home birth. As part of the City Initiative for Newborn Health, we used a key informant surveillance system to identify births prospectively in 48 slum communities in six wards of Mumbai, covering a population of 280,000. Births and outcomes were documented prospectively by local women and mothers were interviewed in detail at six weeks after delivery. We examined the prevalence of home births and their associations with potential determinants using regression models. We described 1708 (16%) home deliveries among 10,754 births over two years, 2005-2007. The proportion varied from 6% to 24%, depending on area. The most commonly cited reasons for home birth were custom and lack of time to reach a healthcare facility during labour. Seventy percent of home deliveries were assisted by a traditional birth attendant (dai), and 6% by skilled health personnel. The median cost of a home delivery was US$ 21, of institutional delivery in the public sector US$ 32, and in the private sector US$ 118. In an adjusted multivariable regression model, the odds of home delivery increased with illiteracy, parity, socioeconomic poverty, poorer housing, lack of water supply, population transience, and hazardous location. We estimate 32,000 annual home births to residents of Mumbai's slums. These are unevenly distributed and cluster with other markers of vulnerability. Since cost does not appear to be a dominant disincentive to institutional delivery, efforts are needed to improve the client experience at public sector institutions. It might also be productive to concentrate on intensive outreach in vulnerable areas by

Validation of the close-to-delivery prediction model for vaginal birth after cesarean delivery in a Middle Eastern cohort.

Science.gov (United States)

Abdel Aziz, Ahmed; Abd Rabbo, Amal; Sayed Ahmed, Waleed A; Khamees, Rasha E; Atwa, Khaled A

2016-07-01

To validate a prediction model for vaginal birth after cesarean (VBAC) that incorporates variables available at admission for delivery among Middle Eastern women. The present prospective cohort study enrolled women at 37weeks of pregnancy or more with cephalic presentation who were willing to attempt a trial of labor (TOL) after a single prior low transverse cesarean delivery at Al-Jahra Hospital, Kuwait, between June 2013 and June 2014. The predicted success rate of VBAC determined via the close-to-delivery prediction model of Grobman et al. was compared between participants whose TOL was and was not successful. Among 203 enrolled women, 140 (69.0%) had successful VBAC. The predicted VBAC success rate was higher among women with successful TOL (82.4%±13.1%) than among those with failed TOL (67.7%±18.3%; P30%-40% to >90%-100%, the actual success rate was 20%, 30.7%, 38.5%, 59.1%, 71.4%, 76%, and 84.5%, respectively (r=0.98, P=0.013). The close-to-delivery prediction model was found to be applicable to Middle Eastern women and might predict VBAC success rates, thereby decreasing morbidities associated with failed TOL. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

The relationship between occupational fatigue and preterm delivery

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Mahbod Ebrahimi

2014-05-01

Full Text Available Background: The presense of women in workplace is an unavoiding issue in modern world. The women work in different media. Occupational activities are suspected of having an adverse impact on outcomes of pregnancy. Premature delivery is a catastrophic event in course of pregnancy. The aim of the study was to define the incidence of premature delivery in occupationally involved pregnant women. Material and Methods: A total of 287 primigravida women in an urban society with singleton pregnancies at 22 to 24 weeks gestation were enrolled in a prospective study. They worked in industrial manufactures. The patients reported the number of hours worked per week and answered specific questions designed to determine the following 5 sources of occupational fatigue including:1- posture ,2- work with industrial machines 3- physical exertion 4-mental stress and 5- environmental stress. Results: The risk of preterm delivery increased with standing more than 3 hours during activities in work place (p.value=0/019. There was not a statistically significant relationship between premature delivery and other sources of occupational fatigue. There was not a statically significant relationship between premature rupture of fetal membranes and the sources of occupational fatigue. There was not a statistically significant relationship between premature delivery and increasing number of hours worked per week. Conclusion: The relationship between premature delivery and occupational fatigue may provide guidelines according to pregnant women and their employers can be advised.

Births in two different delivery units in the same clinic – A prospective study of healthy primiparous women

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Nilsen Anne

2009-06-01

Full Text Available Abstract Background Earlier studies indicate that midwife-led birth settings are associated with modest benefits, including reduced medical interventions and increased maternal satisfaction. The generalizability of these studies to birth settings with low intervention rates, like those generally found in Norway, is not obvious. The aim of the present study was to compare intervention rates associated with labour in low-risk women who begin their labour in a midwife-led unit and a conventional care unit. Methods Eligible participants were low-risk primiparas who met the criteria for delivery in the midwife-led ward regardless of which cohort they were allocated to. The two wards are localised at the same floor. Women in both cohorts received the same standardized public antenatal care by general medical practitioners and midwifes who were not involved in the delivery. After admission of a woman to the midwife-led ward, the next woman who met the inclusion criteria, but preferred delivery at the conventional delivery ward, was allocated to the conventional delivery ward cohort. Among the 252 women in the midwife-led ward cohort, 74 (29% women were transferred to the conventional delivery ward during labour. Results Emergency caesarean and instrumental delivery rates in women who were admitted to the midwife-led and conventional birth wards were statistically non-different, but more women admitted to the conventional birth ward had episiotomy. More women in the conventional delivery ward received epidural analgesia, pudental nerve block and nitrous oxide, while more women in the midwife-led ward received opiates and non-pharmacological pain relief. Conclusion We did not find evidence that starting delivery in the midwife-led setting offers the advantage of lower operative delivery rates. However, epidural analgesia, pudental nerve block and episiotomies were less often while non-pharmacological pain relief was often used in the midwife-led ward.

Prenatal syphilis infection is a possible cause of preterm delivery among immigrant women from eastern Europe.

Science.gov (United States)

Tridapalli, E; Capretti, M G; Sambri, V; Marangoni, A; Moroni, A; D'Antuono, A; Bacchi, M L; Faldella, G

2007-04-01

to evaluate the prevalence of maternal syphilis at delivery and neonatal syphilis infection in an Italian urban area, in connection with the increased flow of immigration. A prospective surveillance study was carried out in Bologna, Italy, from November 2000 to March 2006. All pregnant women were screened for syphilis at delivery. Infants born to seropositive mothers were enrolled in a prospective follow-up. During the study period 19,205 women gave birth to 19,548 infants. A total of 85 women were seropositive for syphilis at delivery. The overall syphilis seroprevalence in pregnant women was 0.44%, but it was 4.3% in women from eastern Europe and 5.8% in women from Central-South America. Ten women were first found positive at delivery, as they did not receive any prenatal care. Nine of these were from eastern Europe. All their infants were asymptomatic, but six had both reactive immunoglobulin (Ig)M western blot and rapid plasma reagin tests and were considered prenatally infected. Three of six were preterm (gestational age eastern Europe. Although it is asymptomatic, it could cause premature delivery. Therefore, it is necessary to perform serological tests during the third trimester in mothers coming from endemic areas to adequately treat syphilis in pregnancy and prevent congenital infection. If the mother's test results are not available at delivery, it is necessary to investigate the newborn, especially if it is born prematurely.

Study protocol. IDUS - Instrumental delivery & ultrasound: a multi-centre randomised controlled trial of ultrasound assessment of the fetal head position versus standard care as an approach to prevent morbidity at instrumental delivery.

LENUS (Irish Health Repository)

Murphy, Deirdre J

2012-01-01

Instrumental deliveries are commonly performed in the United Kingdom and Ireland, with rates of 12 - 17% in most centres. Knowing the exact position of the fetal head is a pre-requisite for safe instrumental delivery. Traditionally, diagnosis of the fetal head position is made on transvaginal digital examination by delineating the suture lines of the fetal skull and the fontanelles. However, the accuracy of transvaginal digital examination can be unreliable and varies between 20% and 75%. Failure to identify the correct fetal head position increases the likelihood of failed instrumental delivery with the additional morbidity of sequential use of instruments or second stage caesarean section. The use of ultrasound in determining the position of the fetal head has been explored but is not part of routine clinical practice.

Effects of delivery mode and sociodemographic factors on postpartum stress urinary incontinency in primipara women: A prospective cohort study

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Roya Kokabi

2017-08-01

Conclusion: Vaginal delivery is associated with a twofold increased risk of postpartum SUI in primipara women compared with elective cesarean section. Age and birth weight are the main risk factors of postpartum SUI in both modes of delivery. Tool-assisted delivery and episiotomy were determined as the risk factors of postpartum SUI in vaginal delivery.

Association between levator hiatal dimensions on ultrasound during first pregnancy and mode of delivery

NARCIS (Netherlands)

van Veelen, G. A.; Schweitzer, K. J.; van Hoogenhuijze, N. E.; van der Vaart, C. H.

Objectives To determine the association between levator hiatal dimensions, measured using transperineal ultrasound, in women during their first pregnancy and the subsequent mode of delivery, stratified by the indication for intervention. Methods In this prospective observational study, 280

Sonographic prediction of outcome of vacuum deliveries

DEFF Research Database (Denmark)

Kahrs, Birgitte H; Usman, Sana; Ghi, Tullio

2017-01-01

of vacuum extraction in relation to ultrasound measured head-perineum distance with a predefined cut-off of 25 mm, and 220 women were needed to discriminate between groups using a hazard ratio of 1.5 with 80% power and alpha 5%. Secondary outcomes were delivery mode and umbilical artery cord blood samples...... outcome in nulliparous women with prolonged second stage of labor. STUDY DESIGN: We performed a prospective cohort study in nulliparous women at term with prolonged second stage of labor in 7 European maternity units from 2013 through 2016. Fetal head position and station were determined using...... after birth. The time interval was evaluated using survival analyses, and the outcomes of delivery were evaluated using receiver operating characteristic curves and descriptive statistics. Results were analyzed according to intention to treat. RESULTS: The study population comprised 222 women...

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

A clinical perspective on mucoadhesive buccal drug delivery systems

Science.gov (United States)

Gilhotra, Ritu M; Ikram, Mohd; Srivastava, Sunny; Gilhotra, Neeraj

2014-01-01

Mucoadhesion can be defined as a state in which two components, of which one is of biological origin, are held together for extended periods of time by the help of interfacial forces. Among the various transmucosal routes, buccal mucosa has excellent accessibility and relatively immobile mucosa, hence suitable for administration of retentive dosage form. The objective of this paper is to review the works done so far in the field of mucoadhesive buccal drug delivery systems (MBDDS), with a clinical perspective. Starting with a brief introduction of the mucoadhesive drug delivery systems, oral mucosa, and the theories of mucoadhesion, this article then proceeds to cover the works done so far in the field of MBDDS, categorizing them on the basis of ailments they are meant to cure. Additionally, we focus on the various patents, recent advancements, and challenges as well as the future prospects for mucoadhesive buccal drug delivery systems. PMID:24683406

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

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

Time from pre-eclampsia diagnosis to delivery affects future health prospects of children

DEFF Research Database (Denmark)

Hollegaard, Birgitte; Lykke, Jacob Alexander; Boomsma, Jacobus Jan

2017-01-01

to either mild or severe pre-eclampsia up to 30 years after birth and related disease risks to duration of exposure, i.e. the time from diagnosis to delivery. Methodology: We did a registry-based retrospective cohort study in Denmark covering the years 1979-2009, using the separate diagnoses of mild...... and severe pre-eclampsia and the duration of exposure as predictor variables for specific and overall risks of later disease. We analysed 3 537 525 diagnoses for 14 disease groups, accumulated by 758 524 singleton children, after subdividing deliveries in six gestational age categories, partialing out......-eclampsia were of similar magnitude as those associated with severe pre-eclampsia. Apart from this overall trend in number of diagnoses incurred across disease groups, hazard ratios for several disorders also increased with the duration of exposure, including disorders related to the metabolic syndrome...

A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery--the FOCCUS study.

Science.gov (United States)

Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Elders, Andrew; Hernández, Rodolfo; Boyers, Dwayne; Norrie, John; Kinsella, John; Brittenden, Julie; Cook, Jonathan; Rae, Daniela; Cotton, Seonaidh C; Alcorn, David; Addison, Jennifer; Grant, Adrian

2011-01-01

Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery. This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome. A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: £2,047; adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective. Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care. Prospective Clinical Trials, ISRCTN32188676.

Determination of a cutoff value for pelvic floor distensibility using the Epi-no balloon to predict perineal integrity in vaginal delivery: ROC curve analysis. Prospective observational single cohort study

Directory of Open Access Journals (Sweden)

Miriam Raquel Diniz Zanetti

Full Text Available CONTEXT AND OBJECTIVE: Several risk factors are involved in perineal lacerations during vaginal delivery. However, little is known about the influence of perineal distensibility as a protective factor. The aim here was to determine a cutoff value for pelvic floor distensibility measured using the Epi-no balloon, which could be used as a predictive factor for perineal integrity in vaginal delivery. DESIGN AND SETTING: Prospective observational single cohort study conducted in a maternity hospital. METHODS: A convenience sample of 227 consecutive at-term parturients was used. All women had a single fetus in the vertex presentation, with up to 9.0 cm of dilation. The maximum dilation of the Epi-no balloon was measured using a tape measure after it had been inflated inside the vagina up to the parturients' maximum tolerance. The receiver operating characteristic (ROC curve was used to obtain the Epi-no circumference measurement with best sensitivity and specificity. RESULTS: Among the 161 patients who were included in the study, 50.9% underwent episiotomy, 21.8% presented lacerations and 27.3% retained an intact perineum. Age > 25.9 years; number of pregnancies > 3.4; number of deliveries > 2.2 and circumference measured by Epi-no > 21.4 cm were all directly correlated with an intact perineum. Circumference measurements using the Epi-no balloon that were greater than 20.8 cm showed sensitivity and specificity of 70.5% and 66.7% (area under curve = 0.713, respectively, as a predictive factor for an intact perineum in vaginal delivery. CONCLUSION: Circumferences greater than 20.8 cm achieved using the Epi-no balloon are a predictive factor for perineal integrity in parturients.

The effect of a structured neonatal resuscitation program on delivery room practices.

LENUS (Irish Health Repository)

Ryan, C A

2012-02-03

PURPOSE: This study evaluated the introduction of the Neonatal Resuscitation Program (NRP) of the American Academy of Pediatrics and the American Heart Association into the delivery room of an Irish maternity hospital. DESIGN: Prospective, controlled observational study of 51 deliveries before and 51 deliveries following the training of delivery room personnel in the NRP. SAMPLE: Participants were 33 nurse-midwives and 11 pediatric resident physicians. MAIN OUTCOME VARIABLE: Evaluation of postdelivery, newborn resuscitation practices. RESULTS: The introduction of the NRP was associated with significant improvements in delivery room preparation, in the evaluation and management of the newborn infant, and in thermal protection at birth. Although there was a trend to use more free-flow oxygen following the introduction of the NRP, this was not statistically significant. Bag and mask ventilation was also used more frequently following NRP training. However, there were no significant differences in the use of endotracheal intubation, chest compressions, and medications. Fifteen of the 51 infants became hypothermic prior to the introduction of the NRP; none of the infants developed hypothermia in the post-NRP part of the study.

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

Gated Treatment Delivery Verification With On-Line Megavoltage Fluoroscopy

International Nuclear Information System (INIS)

Tai An; Christensen, James D.; Gore, Elizabeth; Khamene, Ali; Boettger, Thomas; Li, X. Allen

2010-01-01

Purpose: To develop and clinically demonstrate the use of on-line real-time megavoltage (MV) fluoroscopy for gated treatment delivery verification. Methods and Materials: Megavoltage fluoroscopy (MVF) image sequences were acquired using a flat panel equipped for MV cone-beam CT in synchrony with the respiratory signal obtained from the Anzai gating device. The MVF images can be obtained immediately before or during gated treatment delivery. A prototype software tool (named RTReg4D) was developed to register MVF images with phase-sequenced digitally reconstructed radiograph images generated from the treatment planning system based on four-dimensional CT. The image registration can be used to reposition the patient before or during treatment delivery. To demonstrate the reliability and clinical usefulness, the system was first tested using a thoracic phantom and then prospectively in actual patient treatments under an institutional review board-approved protocol. Results: The quality of the MVF images for lung tumors is adequate for image registration with phase-sequenced digitally reconstructed radiographs. The MVF was found to be useful for monitoring inter- and intrafractional variations of tumor positions. With the planning target volume contour displayed on the MVF images, the system can verify whether the moving target stays within the planning target volume margin during gated delivery. Conclusions: The use of MVF images was found to be clinically effective in detecting discrepancies in tumor location before and during respiration-gated treatment delivery. The tools and process developed can be useful for gated treatment delivery verification.

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

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...

Intake of probiotic food and risk of spontaneous preterm delivery123

Science.gov (United States)

Myhre, Ronny; Brantsæter, Anne Lise; Myking, Solveig; Gjessing, Håkon Kristian; Sengpiel, Verena; Meltzer, Helle Margrete; Haugen, Margaretha; Jacobsson, Bo

2011-01-01

Background: Preterm delivery represents a substantial problem in perinatal medicine worldwide. Current knowledge on potential influences of probiotics in food on pregnancy complications caused by microbes is limited. Objective: We hypothesized that intake of food with probiotics might reduce pregnancy complications caused by pathogenic microorganisms and, through this, reduce the risk of spontaneous preterm delivery. Design: This study was performed in the Norwegian Mother and Child Cohort on the basis of answers to a food-frequency questionnaire. We studied intake of milk-based products containing probiotic lactobacilli and spontaneous preterm delivery by using a prospective cohort study design (n = 950 cases and 17,938 controls) for the pregnancy outcome of spontaneous preterm delivery (<37 gestational weeks). Analyses were adjusted for the covariates of parity, maternal educational level, and physical activity. Results: Pregnancies that resulted in spontaneous preterm delivery were associated with any intake of milk-based probiotic products in an adjusted model [odds ratio (OR): 0.857; 95% CI: 0.741, 0.992]. By categorizing intake into none, low, and high intakes of the milk-based probiotic products, a significant association was observed for high intake (OR: 0.820; 95% CI: 0.681, 0.986). Conclusion: Women who reported habitual intake of probiotic dairy products had a reduced risk of spontaneous preterm delivery. PMID:20980489

Encapsulation systems for the delivery of hydrophilic nutraceuticals: Food application.

Science.gov (United States)

Aditya, N P; Espinosa, Yadira Gonzalez; Norton, Ian T

2017-07-01

Increased health risk associated with the sedentary life style is forcing the food manufacturers to look for food products with specific or general health benefits e.g. beverages enriched with nutraceuticals like catechin, curcumin rutin. Compounds like polyphenols, flavonoids, vitamins are the good choice of bioactive compounds that can be used to fortify the food products to enhance their functionality. However due to low stability and bioavailability of these bioactives (both hydrophobic and hydrophilic) within the heterogeneous food microstructure and in the Gastro Intestinal Tract (GIT), it becomes extremely difficult to pass on the real health benefits to the consumers. Recent developments in the application of nano-delivery systems for food product development is proving to be a game changer which has raised the expectations of the researchers, food manufacturers and consumers regarding possibility of enhancing the functionality of bioactives within the fortified food products. In this direction, nano/micro delivery systems using lipids, surfactants and other materials (carbohydrates, polymers, complexes, protein) have been fabricated to stabilize and enhance the biological activity of the bioactive compounds. In the present review, current status of the various delivery systems that are used for the delivery of hydrophilic bioactives and future prospects for using other delivery systems that have been not completely explored for the delivery of hydrophilic bioactives e.g. niosomes; bilosomes, cubosomes are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

Transforaminal lumbar interbody graft placement using an articulating delivery arm facilitates increased segmental lordosis with superior anterior and midline graft placement.

Science.gov (United States)

Shau, David N; Parker, Scott L; Mendenhall, Stephen K; Zuckerman, Scott L; Godil, Saniya S; Devin, Clinton J; McGirt, Matthew J

2015-05-01

Transforaminal lumbar interbody fusion (TLIF) is a frequently performed method of lumbar arthrodesis in patients failing medical management of back and leg pain. Accurate placement of the interbody graft and restoration of lordosis has been shown to be crucial when performing lumbar fusion procedures. We performed a single-surgeon, prospective, randomized study to determine whether a novel articulating versus traditional straight graft delivery arm system allows for superior graft placement and increased lordosis for single-level TLIF. Thirty consecutive patients undergoing single-level TLIF were included and prospectively randomized to one of the 2 groups (articulated vs. straight delivery arm system). Three radiographic characteristics were evaluated at 6-week follow-up: (1) degree of segmental lumbar lordosis at the fused level; (2) the percent anterior location of the interbody graft in disk space; and (3) the distance (mm) off midline of the interbody graft placement. Randomization yielded 16 patients in the articulated delivery arm cohort and 14 in the straight delivery arm cohort. The articulating delivery arm system yielded an average of 14.7-degree segmental lordosis at fused level, 35% anterior location, and 3.6 mm off midline. The straight delivery arm system yielded an average of 10.7-degree segmental lordosis at fused level, 46% anterior location, and 7.0 mm off midline. All 3 comparisons were statistically significant (Plordosis compared with a traditional straight delivery arm system.

Prospective study of determinants and costs of home births in Mumbai slums

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Das Sushmita

2010-07-01

Full Text Available Abstract Background Around 86% of births in Mumbai, India, occur in healthcare institutions, but this aggregate figure hides substantial variation and little is known about urban home births. We aimed to explore factors influencing the choice of home delivery, care practices and costs, and to identify characteristics of women, households and the environment which might increase the likelihood of home birth. Methods As part of the City Initiative for Newborn Health, we used a key informant surveillance system to identify births prospectively in 48 slum communities in six wards of Mumbai, covering a population of 280 000. Births and outcomes were documented prospectively by local women and mothers were interviewed in detail at six weeks after delivery. We examined the prevalence of home births and their associations with potential determinants using regression models. Results We described 1708 (16% home deliveries among 10 754 births over two years, 2005-2007. The proportion varied from 6% to 24%, depending on area. The most commonly cited reasons for home birth were custom and lack of time to reach a healthcare facility during labour. Seventy percent of home deliveries were assisted by a traditional birth attendant (dai, and 6% by skilled health personnel. The median cost of a home delivery was US$ 21, of institutional delivery in the public sector US$ 32, and in the private sector US$ 118. In an adjusted multivariable regression model, the odds of home delivery increased with illiteracy, parity, socioeconomic poverty, poorer housing, lack of water supply, population transience, and hazardous location. Conclusions We estimate 32 000 annual home births to residents of Mumbai's slums. These are unevenly distributed and cluster with other markers of vulnerability. Since cost does not appear to be a dominant disincentive to institutional delivery, efforts are needed to improve the client experience at public sector institutions. It might also be

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.

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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

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

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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.

Microparticles, microcapsules and microspheres: A review of recent developments and prospects for oral delivery of insulin.

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Wong, Chun Y; Al-Salami, Hani; Dass, Crispin R

2018-02-15

Diabetes mellitus is a chronic metabolic health disease affecting the homeostasis of blood sugar levels. However, subcutaneous injection of insulin can lead to patient non-compliance, discomfort, pain and local infection. Sub-micron sized drug delivery systems have gained attention in oral delivery of insulin for diabetes treatment. In most of the recent literature, the terms "microparticles" and "nanoparticle" refer to particles where the dimensions of the particle are measured in micrometers and nanometers respectively. For instance, insulin-loaded particles are defined as microparticles with size larger than 1 μm by most of the research groups. The size difference between nanoparticles and microparticles proffers numerous effects on the drug loading efficiency, aggregation, permeability across the biological membranes, cell entry and tissue retention. For instance, microparticulate drug delivery systems have demonstrated a number of advantages including protective effect against enzymatic degradation, enhancement of peptide stability, site-specific and controlled drug release. Compared to nanoparticulate drug delivery systems, microparticulate formulations can facilitate oral absorption of insulin by paracellular, transcellular and lymphatic routes. In this article, we review the current status of microparticles, microcapsules and microspheres for oral administration of insulin. A number of novel techniques including layer-by-layer coating, self-polymerisation of shell, nanocomposite microparticulate drug delivery system seem to be promising for enhancing the oral bioavailability of insulin. This review draws several conclusions for future directions and challenges to be addressed for optimising the properties of microparticulate drug formulations and enhancing their hypoglycaemic effects. Copyright © 2017 Elsevier B.V. All rights reserved.

[Optimum approach to delivery for control of premature birth (author's transl)].

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Nieder, J; Lattorff, E

1980-01-01

Foetal condition and neonatal mortality of 637 prematurely born children with birth weights below 2,501 g were analysed, depending on modes of delivery, such as spontaneous birth, speculum delivery, use of forceps, manual support, and caesarean section. The clinical condition of the newborn, assessed five minutes from parturition by Apgar score 1, was found to depend primarily on birth weight rather than on the mode of delivery. The average Apgar values were lower for less mature newborns. While Apgar scores were worst for newborns after caesarean section delivery, the differences between approaches to delivery could not be statistically secured. Neonatal mortality went up, according to expectation, along with dropping birth weight. The mortality rate of premature births below 1,501 g was not affected by delivery modes. Prophylactic use of Shute forceps and speculum delivery appeared to be superior to spontaneous birth in the medium weight class, between 1,501 g and 2,000 g. Yet, not even here were the differences between clear postnatal mortality rates statistically secured. -Lowest mortality figures were recorded from spontaneous birth in the weight class between 2,001 g and 2,500 g, but significant differences were established only to speculum delivery. Premature newborns after caesarean section had poorer prospects than all variants of vaginal birth, but among the latter premature births from breech presentation were more endangered than others. Decisions as to vaginal, abdominal, spontaneous proprophylactically surgical approaches to premature deliveries should be taken for every individual case and due consideration of many factors.

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

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/

Promising approaches to circumvent the blood-brain barrier: progress, pitfalls and clinical prospects in brain cancer.

Science.gov (United States)

Papademetriou, Iason T; Porter, Tyrone

2015-01-01

Brain drug delivery is a major challenge for therapy of central nervous system (CNS) diseases. Biochemical modifications of drugs or drug nanocarriers, methods of local delivery, and blood-brain barrier (BBB) disruption with focused ultrasound and microbubbles are promising approaches which enhance transport or bypass the BBB. These approaches are discussed in the context of brain cancer as an example in CNS drug development. Targeting to receptors enabling transport across the BBB offers noninvasive delivery of small molecule and biological cancer therapeutics. Local delivery methods enable high dose delivery while avoiding systemic exposure. BBB disruption with focused ultrasound and microbubbles offers local and noninvasive treatment. Clinical trials show the prospects of these technologies and point to challenges for the future.

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

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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.

Correlates of facility delivery for rural HIV-positive pregnant women enrolled in the MoMent Nigeria prospective cohort study.

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Sam-Agudu, Nadia A; Isah, Christopher; Fan-Osuala, Chinenye; Erekaha, Salome; Ramadhani, Habib O; Anaba, Udochisom; Adeyemi, Olusegun A; Manji-Obadiah, Grace; Lee, Daniel; Cornelius, Llewellyn J; Charurat, Manhattan

2017-07-14

Low rates of maternal healthcare service utilization, including facility delivery, may impede progress in the prevention of mother-to-child transmission of HIV (PMTCT) and in reducing maternal and infant mortality. The MoMent (Mother Mentor) study investigated the impact of structured peer support on early infant diagnosis presentation and postpartum maternal retention in PMTCT care in rural Nigeria. This paper describes baseline characteristics and correlates of facility delivery among MoMent study participants. HIV-positive pregnant women were recruited at 20 rural Primary Healthcare Centers matched by antenatal care clinic volume, client HIV prevalence, and PMTCT service staffing. Baseline and delivery data were collected by participant interviews and medical record abstraction. Multivariate logistic regression with generalized estimating equation analysis was used to evaluate for correlates of facility delivery including exposure to structured (closely supervised Mentor Mother, intervention) vs unstructured (routine, control) peer support. Of 497 women enrolled, 352 (71%) were between 21 and 30 years old, 319 (64%) were Christian, 245 (49%) had received secondary or higher education, 402 (81%) were multigravidae and 299 (60%) newly HIV-diagnosed. Delivery data was available for 445 (90%) participants, and 276 (62%) of these women delivered at a health facility. Facility delivery did not differ by type of peer support; however, it was positively associated with secondary or greater education (aOR 1.9, CI 1.1-3.2) and Christian affiliation (OR 1.4, CI 1.0-2.0) and negatively associated with primigravidity (OR 0.5; 0.3-0.9) and new HIV diagnosis (OR 0.6, CI 0.4-0.9). Primary-level or lesser-educated HIV-infected pregnant women and those newly-diagnosed and primigravid should be prioritized for interventions to improve facility delivery rates and ultimately, healthy outcomes. Incremental gains in facility delivery from structured peer support appear limited

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

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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

Probability of cesarean delivery after successful external cephalic version.

Science.gov (United States)

Burgos, Jorge; Iglesias, María; Pijoan, José I; Rodriguez, Leire; Fernández-Llebrez, Luis; Martínez-Astorquiza, Txantón

2015-11-01

To identify factors associated with cesarean delivery following successful external cephalic version (ECV). In a prospective study, data were obtained for ECV procedures performed at Cruces University Hospital, Spain, between March 2002 and June 2012. Women with a singleton pregnancy who had a successful, uncomplicated ECV and whose delivery was assisted at the study hospital, with the fetus in cephalic presentation, were included. A multivariate model of risk factors of cesarean delivery was developed. Among 627 women included, 92 (14.7%) delivered by cesarean. A cesarean was performed among 33 (8.5%) of 387 women with spontaneous labor versus 59 (24.6%) of 240 who were induced (P < 0.001). Multivariate analysis showed that higher BMI (P = 0.006), labor induction (P = 0.001), and prior cesarean (P < 0.001) were associated with cesarean. Time between ECV and delivery was inversely associated with probability of cesarean during the first 2 weeks. Thus, the probabilities of cesarean delivery on the first day were 0.53 (95% CI 0.35-0.71) and 0.34 (95% CI 0.18-0.51) following induced and spontaneous labor, respectively. On the seventh day, the probabilities were 0.23 (95% CI 0.15-0.32) and 0.12 (95% CI 0.07-0.18), respectively. Following ECV, induction of labor, an interval of less than 2 weeks to delivery, BMI, and previous cesarean were associated with an increased risk of cesarean. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Nano-enabled drug delivery: a research profile.

Science.gov (United States)

Zhou, Xiao; Porter, Alan L; Robinson, Douglas K R; Shim, Min Suk; Guo, Ying

2014-07-01

Nano-enabled drug delivery (NEDD) systems are rapidly emerging as a key area for nanotechnology application. Understanding the status and developmental prospects of this area around the world is important to determine research priorities, and to evaluate and direct progress. Global research publication and patent databases provide a reservoir of information that can be tapped to provide intelligence for such needs. Here, we present a process to allow for extraction of NEDD-related information from these databases by involving topical experts. This process incorporates in-depth analysis of NEDD literature review papers to identify key subsystems and major topics. We then use these to structure global analysis of NEDD research topical trends and collaborative patterns, inform future innovation directions. This paper describes the process of how to derive nano-enabled drug delivery-related information from global research and patent databases in an effort to perform comprehensive global analysis of research trends and directions, along with collaborative patterns. Copyright © 2014 Elsevier Inc. All rights reserved.

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)

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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

Medicaid prospective payment: Case-mix increase

Science.gov (United States)

Baker, Samuel L.; Kronenfeld, Jennie J.

1990-01-01

South Carolina Medicaid implemented prospective payment by diagnosis-related group (DRG) for inpatient care. The rate of complications among newborns and deliveries doubled immediately. The case-mix index for newborns increased 66.6 percent, which increased the total Medicaid hospital expenditure 5.5 percent. Outlier payments increased total expenditure further. DRG distribution change among newborns has a large impact on spending because newborn complication DRGs have high weights. States adopting a DRG-based payment system for Medicaid should anticipate a greater increase in case mix than Medicare experienced. PMID:10113463

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

Nicotine patches in pregnant smokers: randomised, placebo controlled, multicentre trial of efficacy

Science.gov (United States)

Grangé, Gilles; Jacob, Nelly; Tanguy, Marie-Laure

2014-01-01

Objective To determine the efficacy of 16 hour nicotine patches among pregnant smokers, with the dose individually adjusted according to saliva cotinine levels (potential range 10-30 mg/day). Design Randomised, double blind, placebo controlled, parallel group, multicentre trial (Study of Nicotine Patch in Pregnancy, SNIPP) between October 2007 and January 2013. Setting 23 maternity wards in France. Participants 476 pregnant smokers aged more than 18 years and between 12 and 20 weeks’ gestation, who smoked at least five cigarettes a day. After exclusions, 402 women were randomised: 203 to nicotine patches and 199 to placebo patches. Data were available on 192 live births in each group. Interventions Nicotine and identical placebo patches were administered from quit day up to the time of delivery. Doses were adjusted to saliva cotinine levels when smoking to yield a substitution rate of 100%. Participants were assessed monthly and received behavioural smoking cessation support. Main outcome measures The primary outcomes were complete abstinence (self report confirmed by carbon monoxide level in expired air ≤8 ppm) from quit date to delivery, and birth weight. The secondary outcomes were point prevalence of abstinence, time to lapse (a few puffs) or relapse, and delivery and birth characteristics. All data were analysed on an intention to treat basis. Results Complete abstinence was achieved by 5.5% (n=11) of women in the nicotine patch group and 5.1% (n=10) in the placebo patch group (odds ratio 1.08, 95% confidence interval 0.45 to 2.60). The median time to the first cigarette smoked after target quit day was 15 days in both groups (interquartile range 13-18 in the nicotine patch group, 13-20 in the placebo patch group). The point prevalence abstinence ranged from 8% to 12.5% in the nicotine patch group and 8% to 9.5% in the placebo patch group without statistically significant differences. The nicotine substitution rate did not differ from 100%, and the self

Multidisciplinary perspectives for Alzheimer's and Parkinson's diseases: hydrogels for protein delivery and cell-based drug delivery as therapeutic strategies.

Science.gov (United States)

Giordano, Carmen; Albani, Diego; Gloria, Antonio; Tunesi, Marta; Batelli, Sara; Russo, Teresa; Forloni, Gianluigi; Ambrosio, Luigi; Cigada, Alberto

2009-12-01

This review presents two intriguing multidisciplinary strategies that might make the difference in the treatment of neurodegenerative disorders such as Alzheimer's and Parkinson's diseases. The first proposed strategy is based on the controlled delivery of recombinant proteins known to play a key role in these neurodegenerative disorders that are released in situ by optimized polymer-based systems. The second strategy is the use of engineered cells, encapsulated and delivered in situ by suitable polymer-based systems, that act as drug reservoirs and allow the delivery of selected molecules to be used in the treatment of Alzheimer's and Parkinson's diseases. In both these scenarios, the design and development of optimized polymer-based drug delivery and cell housing systems for central nervous system applications represent a key requirement. Materials science provides suitable hydrogel-based tools to be optimized together with suitably designed recombinant proteins or drug delivering-cells that, once in situ, can provide an effective treatment for these neurodegenerative disorders. In this scenario, only interdisciplinary research that fully integrates biology, biochemistry, medicine and materials science can provide a springboard for the development of suitable therapeutic tools, not only for the treatment of Alzheimer's and Parkinson's diseases but also, prospectively, for a wide range of severe neurodegenerative disorders.

Effect of subsequent vaginal delivery on bowel symptoms and anorectal function in women who sustained a previous obstetric anal sphincter injury.

Science.gov (United States)

Jordan, Polly A; Naidu, Madhu; Thakar, Ranee; Sultan, Abdul H

2018-03-29

Our primary objective was to prospectively evaluate anorectal symptoms, anal manometry and endoanal ultrasound (EAUS) in women who followed the recommended mode of subsequent delivery following index obstetric anal sphincter injuries (OASIs) using our unit's standardised protocol. Our secondary objectives were to evaluate the role of internal anal sphincter defects and also to compare outcomes in a subgroup of symptomatic women with normal anorectal physiology. This is a prospective follow-up study of pregnant women with previous OASIs who were counselled regarding subsequent mode of delivery between January 2003 and December 2014. Assessment involved the St Mark's Incontinence Score (SMIS), anal manometry and EAUS at both antepartum and 3-month postpartum visits. Data were analysed using Wilcoxon and Mann-Whitney U tests. Three hundred and fifty women attended the perineal clinic over the study period, of whom 122 met the inclusion criteria (99 vaginal delivery [VD], 23 caesarean section). No significant worsening of anorectal symptoms was observed following subsequent delivery in the VD group (p = 0.896), although a reduced squeeze pressure was observed at 3 months postpartum (p delivery. In the absence of a randomised study, use of this protocol can aid clinicians in their decision-making.

Prostate HDR brachytherapy catheter displacement between planning and treatment delivery

International Nuclear Information System (INIS)

Whitaker, May; Hruby, George; Lovett, Aimee; Patanjali, Nitya

2011-01-01

Background and purpose: HDR brachytherapy is used as a conformal boost for treating prostate cancer. Given the large doses delivered, it is critical that the volume treated matches that planned. Our outpatient protocol comprises two 9 Gy fractions, two weeks apart. We prospectively assessed catheter displacement between CT planning and treatment delivery. Materials and methods: Three fiducial markers and the catheters were implanted under transrectal ultrasound guidance. Metal marker wires were inserted into 4 reference catheters before CT; marker positions relative to each other and to the marker wires were measured from the CT scout. Measurements were repeated immediately prior to treatment delivery using pelvic X-ray with marker wires in the same reference catheters. Measurements from CT scout and film were compared. For displacements of 5 mm or more, indexer positions were adjusted prior to treatment delivery. Results: Results are based on 48 implants, in 25 patients. Median time from planning CT to treatment delivery was 254 min (range 81–367 min). Median catheter displacement was 7.5 mm (range −2.9–23.9 mm), 67% of implants had displacement of 5 mm or greater. Displacements were predominantly caudal. Conclusions: Catheter displacement can occur in the 1–3 h between the planning CT scan and treatment. It is recommended that departments performing HDR prostate brachytherapy verify catheter positions immediately prior to treatment delivery.

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)

Emergency peripartum hysterectomy: results from the prospective Nordic Obstetric Surveillance Study (NOSS).

Science.gov (United States)

Jakobsson, Maija; Tapper, Anna-Maija; Colmorn, Lotte Berdiin; Lindqvist, Pelle G; Klungsøyr, Kari; Krebs, Lone; Børdahl, Per E; Gottvall, Karin; Källén, Karin; Bjarnadóttir, Ragnheiður I; Langhoff-Roos, Jens; Gissler, Mika

2015-07-01

To assess the prevalence and risk factors of emergency peripartum hysterectomy. Nordic collaborative study. 605 362 deliveries across the five Nordic countries. We collected data prospectively from patients undergoing emergency peripartum hysterectomy within 7 days of delivery from medical birth registers and hospital discharge registers. Control populations consisted of all other women delivering on the same units during the same time period. Emergency peripartum hysterectomy rate. The total number of emergency peripartum hysterectomies reached 211, yielding an incidence rate of 3.5/10 000 (95% confidence interval 3.0-4.0) births. Finland had the highest prevalence (5.1) and Norway the lowest (2.9). Primary indications included an abnormally invasive placenta (n = 91, 43.1%), atonic bleeding (n = 69, 32.7%), uterine rupture (n = 31, 14.7%), other bleeding disorders (n = 12, 5.7%), and other indications (n = 8, 3.8%). The delivery mode was cesarean section in nearly 80% of cases. Previous cesarean section was reported in 45% of women. Both preterm and post-term birth increased the risk for emergency peripartum hysterectomy. The number of stillbirths was substantially high (70/1000), but the case fatality rate stood at 0.47% (one death, maternal mortality rate 0.17/100 000 deliveries). A combination of prospective data collected from clinicians and information gathered from register-based databases can yield valuable data, improving the registration accuracy for rare, near-miss cases. However, proper and uniform clinical guidelines for the use of well-defined international diagnostic codes are still needed. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

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.

pH-Responsive carriers for oral drug delivery: challenges and opportunities of current platforms.

Science.gov (United States)

Liu, Lin; Yao, WenDong; Rao, YueFeng; Lu, XiaoYang; Gao, JianQing

2017-11-01

Oral administration is a desirable alternative of parenteral administration due to the convenience and increased compliance to patients, especially for chronic diseases that require frequent administration. The oral drug delivery is a dynamic research field despite the numerous challenges limiting their effective delivery, such as enzyme degradation, hydrolysis and low permeability of intestinal epithelium in the gastrointestinal (GI) tract. pH-Responsive carriers offer excellent potential as oral therapeutic systems due to enhancing the stability of drug delivery in stomach and achieving controlled release in intestines. This review provides a wide perspective on current status of pH-responsive oral drug delivery systems prepared mainly with organic polymers or inorganic materials, including the strategies used to overcome GI barriers, the challenges in their development and future prospects, with focus on technology trends to improve the bioavailability of orally delivered drugs, the mechanisms of drug release from pH-responsive oral formulations, and their application for drug delivery, such as protein and peptide therapeutics, vaccination, inflammatory bowel disease (IBD) and bacterial infections.

Manual rotation to decrease operative delivery in posterior or transverse positions.

Science.gov (United States)

Le Ray, Camille; Deneux-Tharaux, Catherine; Khireddine, Imane; Dreyfus, Michel; Vardon, Delphine; Goffinet, François

2013-09-01

To assess the effect of a policy of manual rotation on the mode of delivery of fetuses in posterior or transverse positions at full dilatation. This was a prospective study to compare two policies of management for posterior and transverse positions in two different hospitals (Hospital 1: no manual rotation and Hospital 2: manual rotation). We used univariable and multivariable analyses to study the association between the management policy for posterior and transverse positions at full dilatation in these hospitals and maternal and neonatal outcomes. The principal end point was operative delivery (ie, cesarean or instrumental vaginal delivery). All factors associated with the risk of operative delivery in the univariable analysis (Pmanual rotation was independently associated with a reduction in operative deliveries. The rate of posterior or transverse positions at full dilatation was 15.9% (n=111) in Hospital 1 and 15.3% (n=220) in Hospital 2 (P=.75). Of the 172 attempts of manual rotation in Hospital 2, 155 (90.1%) were successful. The rate of operative delivery was significantly lower in Hospital 2, which performed manual rotations (23.2% compared with 38.7% in Hospital 1, adjusted odds ratio [OR] 0.52, 95% confidence interval [CI] 0.28-0.95). After multivariable analysis, manual rotation remained significantly associated with a reduction in the risk of operative delivery (adjusted OR 0.45, 95% CI 0.25-0.85). Five-minute Apgar score and arterial pH at birth were similar in the two hospitals. For fetuses in posterior or transverse positions at full dilatation, a strategy of manual rotation is associated with a reduction in the rate of operative delivery. III.

Dual recombinant Lactococcus lactis for enhanced delivery of DNA vaccine reporter plasmid pPERDBY.

Science.gov (United States)

Yagnik, Bhrugu; Sharma, Drashya; Padh, Harish; Desai, Priti

2017-04-01

Food grade Lactococcus lactis has been widely used as an antigen and DNA delivery vehicle. We have previously reported the use of non-invasive L. lactis to deliver the newly constructed immunostimulatory DNA vaccine reporter plasmid, pPERDBY. In the present report, construction of dual recombinant L. lactis expressing internalin A of Listeria monocytogenes and harboring pPERDBY (LL InlA + pPERDBY) to enhance the efficiency of delivery of DNA by L. lactis is outlined. After confirmation and validation of LL InlA + pPERDBY, its DNA delivery potential was compared with previously developed non-invasive r- L. lactis::pPERDBY. The use of invasive L. lactis resulted in around threefold increases in the number of enhanced green fluorescent protein-expressing Caco-2 cells. These findings reinforce the prospective application of invasive strain of L. lactis for delivery of DNA/RNA and antigens. © 2017 The Societies and John Wiley & Sons Australia, Ltd.

Is Cesarean Delivery Preferable in Twin Pregnancies at >=36 Weeks Gestation?

Science.gov (United States)

Dong, Yu; Luo, Zhong-Cheng; Yang, Zu-Jing; Chen, Lu; Guo, Yu-Na; Branch, Ware; Zhang, Jun; Huang, Hong

2016-01-01

Background The optimal mode of delivery in twin pregnancies remains controversial. A recent randomized trial did not find any benefit of planned cesarean vs. vaginal delivery at 32–38 weeks gestation, but the trial was not powered to detect a moderate effect. We aimed to evaluate the impact of cesarean delivery on perinatal mortality and severe neonatal morbidity in twin pregnancies at ≥32 weeks through a large database exploration approach with the power to detect moderate risk differences. Methods In a retrospective birth cohort study using the U.S. matched multiple births, 1995–2000 (the available largest multiple birth dataset), we compared perinatal outcomes in twins (n = 181,810 pregnancies) delivered at 32–41 weeks gestation without congenital anomalies. The primary outcome was a composite of perinatal death and severe neonatal morbidity. Cox regression was used to estimate the adjusted hazard ratio (aHR) controlling for the propensity to cesarean delivery, fetal characteristics (sex, birth weight, birth weight discordance, same-sex twin or not) and twin-cluster level dependence. Prospective risks were calculated using the fetuses-at-risk denominators. Results The overall rates of the primary outcome were slightly lower in intended cesarean (6.20%) vs. vaginal (6.45%) deliveries. The aHRs of the primary outcome were in favor of vaginal delivery at 32 (aHR = 1.06, p = 0.03) or 33 (aHR = 1.22, pcesarean delivery at 36 (aHR = 0.94, p = 0.004), 37, 38 and 39+ weeks (aHR: 0.72 to 0.78, all pcesarean vs. vaginal deliveries at 36+ weeks of gestation remained when the analyses were restricted to different-sex (dichorionic) twins (aHR = 0.84, 95% CI 0.80–0.88). Conclusion Cesarean delivery may be beneficial for perinatal outcomes overall in twin pregnancies at ≥36 weeks gestation. PMID:27227678

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.)

Pre-trial quality assurance processes for an intensity-modulated radiation therapy (IMRT) trial: PARSPORT, a UK multicentre Phase III trial comparing conventional radiotherapy and parotid-sparing IMRT for locally advanced head and neck cancer.

Science.gov (United States)

Clark, C H; Miles, E A; Urbano, M T Guerrero; Bhide, S A; Bidmead, A M; Harrington, K J; Nutting, C M

2009-07-01

The purpose of this study was to compare conventional radiotherapy with parotid gland-sparing intensity-modulated radiation therapy (IMRT) using the PARSPORT trial. The validity of such a trial depends on the radiotherapy planning and delivery meeting a defined standard across all centres. At the outset, many of the centres had little or no experience of delivering IMRT; therefore, quality assurance processes were devised to ensure consistency and standardisation of all processes for comparison within the trial. The pre-trial quality assurance (QA) programme and results are described. Each centre undertook exercises in target volume definition and treatment planning, completed a resource questionnaire and produced a process document. Additionally, the QA team visited each participating centre. Each exercise had to be accepted before patients could be recruited into the trial. 10 centres successfully completed the quality assurance exercises. A range of treatment planning systems, linear accelerators and delivery methods were used for the planning exercises, and all the plans created reached the standard required for participation in this multicentre trial. All 10 participating centres achieved implementation of a comprehensive and robust IMRT programme for treatment of head and neck cancer.

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

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...

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

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

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).

Remifentanil patient controlled analgesia versus epidural analgesia in labour. A multicentre randomized controlled trial

Directory of Open Access Journals (Sweden)

Freeman Liv M

2012-07-01

Full Text Available Abstract Background Pain relief during labour is a topic of major interest in the Netherlands. Epidural analgesia is considered to be the most effective method of pain relief and recommended as first choice. However its uptake by pregnant women is limited compared to other western countries, partly as a result of non-availability due to logistic problems. Remifentanil, a synthetic opioid, is very suitable for patient controlled analgesia. Recent studies show that epidural analgesia is superior to remifentanil patient controlled analgesia in terms of pain intensity score; however there was no difference in satisfaction with pain relief between both treatments. Methods/design The proposed study is a multicentre randomized controlled study that assesses the cost-effectiveness of remifentanil patient controlled analgesia compared to epidural analgesia. We hypothesize that remifentanil patient controlled analgesia is as effective in improving pain appreciation scores as epidural analgesia, with lower costs and easier achievement of 24 hours availability of pain relief for women in labour and efficient pain relief for those with a contraindication for epidural analgesia. Eligible women will be informed about the study and randomized before active labour has started. Women will be randomly allocated to a strategy based on epidural analgesia or on remifentanil patient controlled analgesia when they request pain relief during labour. Primary outcome is the pain appreciation score, i.e. satisfaction with pain relief. Secondary outcome parameters are costs, patient satisfaction, pain scores (pain-intensity, mode of delivery and maternal and neonatal side effects. The economic analysis will be performed from a short-term healthcare perspective. For both strategies the cost of perinatal care for mother and child, starting at the onset of labour and ending ten days after delivery, will be registered and compared. Discussion This study, considering cost

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

Hepcidin levels are low during pregnancy and increase around delivery in women without iron deficiency - a prospective cohort study

DEFF Research Database (Denmark)

Hedengran, Katrine K; Nelson, Dick; Andersen, Malene R

2015-01-01

OBJECTIVE: To investigate hepcidin during pregnancy, delivery and postpartum in women with sufficient iron supplementation. METHODS: Hepcidin was measured using LC-MS spectroscopy in 37 women during pregnancy, delivery and postpartum period in this longitudinal study. RESULTS: Hepcidin was low du...

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

A comprehensive assessment of maternal deaths in Argentina: translating multicentre collaborative research into action.

Science.gov (United States)

Ramos, Silvina; Karolinski, Ariel; Romero, Mariana; Mercer, Raúl

2007-08-01

To perform a comprehensive assessment of maternal mortality in Argentina, the ultimate purpose being to strengthen the surveillance system and reorient reproductive health policies to prevent maternal deaths. Our multicentre population-based study combining qualitative and quantitative methodologies included a descriptive analysis of under-registration and distribution of causes of death, a case-control study to identify risk factors in health-care delivery and verbal autopsies to analyse social determinants associated with maternal deaths. A total of 121 maternal deaths occurred during 2002. The most common causes were abortion complications (27.4%), haemorrhage (22.1%), infection/sepsis (9.5%), hypertensive disorders (8.4%) and other causes (32.6%). Under-registration was 9.5% for maternal deaths (n = 95) and 15.4% for late maternal deaths (n = 26). The probability of dying was 10 times greater in the absence of essential obstetric care, active emergency care and qualified staff, and doubled with every 10-year increase in age. Other contributing factors included delays in recognizing "alarm signals"; reluctance in seeking care owing to desire to hide an induced abortion; delays in receiving timely treatment due to misdiagnosis or lack of supplies; and delays in referral/transportation in rural areas. A combination of methodologies is required to improve research on and understanding of maternal mortality via the systematic collection of health surveillance data. There is an urgent need for a comprehensive intervention to address public health and human rights issues in maternal mortality, and our results contribute to the consensus-building necessary to improve the existing surveillance system and prevention strategies.

Impact of the prospective payment system on the delivery of nuclear medicine services

International Nuclear Information System (INIS)

Crucitti, T.W.; Pappas, V.M.

1986-07-01

The study evaluates the effect of the Medicare Prospective Payment System (PPS) on nuclear medicine technologists and services. Since 80% of nuclear medicine technologists work in hospitals, a large segment of the professionals would be affected by the new system. The survey was designed to assess the PPSs effect on nuclear medicine departments at the early implementation stage

A cross-sectional study exploring the incidence of and indications for second-stage cesarean delivery over three decades.

Science.gov (United States)

Pearson, Greg A; MacKenzie, Ian Z

2017-09-01

To observe the incidence of, indications for, and complications associated with second-stage cesarean delivery in 10-year intervals over 30 years. The present analysis of prospectively collected data compared cesarean deliveries during 1976, 1986, 1996, and 2006 at John Radcliffe Hospital in Oxford, UK (n=3222). Pregnancy, delivery, and neonatal details were reviewed. The proportion of deliveries by cesarean in the second stage of labor increased from 0.5% (22/4464) in 1976 to 2.1% (124/5998) in 2006 (Pcesarean deliveries during the second stage because of failed instrumental delivery also increased over the study period from 59.1% (13/22) in 1976 to 71.0% (88/124) in 2006. Compared with cesareans at other stages, uterine trauma (Pcesarean delivery. Neonates delivered by second-stage cesarean had lower Apgar scores (Pcesarean earlier in labor. A trend towards an increase in neonatal trauma with second-stage cesarean compared with cesarean delivery before labor or during the first stage did not reach statistical significance. The proportion of deliveries by cesarean in the second stage of labor increased; these deliveries were associated with greater maternal and neonatal morbidity, but were not influenced by the indication for cesarean. © 2017 International Federation of Gynecology and Obstetrics.

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.

Characteristics of patients with rheumatoid arthritis presenting for physiotherapy management: a multicentre study.

Science.gov (United States)

Kennedy, Norelee; Keogan, Fiona; Fitzpatrick, Martina; Cussen, Grainne; Wallace, Lorraine

2007-03-01

To describe the characteristics of patients with rheumatoid arthritis (RA) attending for physiotherapy management in Ireland. Managers of physiotherapy departments in the 53 hospitals in Ireland were invited to participate in a multi-centre observational study over a 6-month period. Data on patients with RA the day of presentation for physiotherapy management were recorded. These data related to patient demographic details, disease management, aids and appliances, splint and orthoses usage and occupational issues. The Health Assessment Questionnaire was also recorded for each patient. A total of 273 patients from eight physiotherapy departments participated in the survey (n = 199; 73% female). Mean age of the participants was 59.3 (SD 12.5) years with mean disease duration of 13.8 (SD 10.6) years. The majority of the patients were inpatients (n = 170, 62%). Sixty-eight per cent of patients had attended for previous physiotherapy treatment and 98% were under current rheumatologist care. Biologic therapies were prescribed to 11% of patients. Use of splint and foot orthoses was high with 133 patients (49%) wearing splints and 75 (31%) wearing foot orthoses. The majority of patients had moderate (n = 119, 44%) or severe (n = 94, 35%) disability as per Health Assessment Questionnaire (HAQ) score. Mean HAQ score was 1.5, with HAQ scores showing increasing disability with increasing age, disease duration and erythrocyte sedimentation rate (ESR) levels. Patients with RA attending for physiotherapy management present with varied profiles. This study provides valuable information on the characteristics of patients with RA attending for physiotherapy management which will contribute to physiotherapy service planning and delivery and will optimize patient care.

Effect of an electronic nicotine delivery device (e-Cigarette on smoking reduction and cessation: a prospective 6-month pilot study

Directory of Open Access Journals (Sweden)

Papale Gabriella

2011-10-01

Full Text Available Abstract Background Cigarette smoking is a tough addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette, a battery-powered electronic nicotine delivery device (ENDD resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated. Methods In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers (unwilling to quit experimenting the 'Categoria' e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. Results Sustained 50% reduction in the number of cig/day at week-24 was shown in 13/40(32.5% participants; their median of 25 cigs/day decreasing to 6 cigs/day (p Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit (http://ClinicalTrials.gov number NCT01195597.

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.)

Overcoming the Challenges of siRNA Delivery: Nanoparticle Strategies.

Science.gov (United States)

Shajari, Neda; Mansoori, Behzad; Davudian, Sadaf; Mohammadi, Ali; Baradaran, Behzad

2017-01-01

Despite therapeutics based on siRNA have an immense potential for the treatment of incurable diseases such as cancers. However, the in vivo utilization of siRNA and also the delivery of this agent to the target site is one of the most controversial challenges. The helpful assistance by nanoparticles can improve stable delivery and also enhance efficacy. More nanoparticle-based siRNA therapeutics is expected to become available in the near future. The search strategy followed the guidelines of the Centre of Reviews and Dissemination. The studies were identified from seven databases (Scopus, Web of Science, Academic Search Premiere, CINAHL, Medline Ovid, Eric and Cochrane Library). Studies was selected based on titles, abstracts and full texts. One hundred twenty nine papers were included in the review. These papers defined hurdles in RNAi delivery and also strategies to overcome these hurdles. This review discussed the existing hurdles for systemic administration of siRNA as therapeutic agents and highlights the various strategies to overcome these hurdles, including lipid-based nanoparticles and polymeric nanoparticles, and we also briefly reviewed chemical modification. Delivery of siRNA to the target site is the biggest challenge for its application in the clinic. The findings of this review confirmed by encapsulation siRNA in the nanoparticles can overcome these challenges. The rapid progress in nanotechnology has enabled the development of effective nanoparticles as the carrier for siRNA delivery. However, our data about siRNA-based therapeutics and also nanomedicine are still limited. More clinical data needs to be completely understood in the benefits and drawbacks of siRNA-based therapeutics. Prospective studies must pay attention to the in vivo safety profiles of the different delivery systems, including uninvited immune system stimulation and cytotoxicity. In essence, the development of nontoxic, biocompatible, and biodegradable delivery systems for

Molecularly Imprinted Polymers: Novel Discovery for Drug Delivery.

Science.gov (United States)

Dhanashree, Surve; Priyanka, Mohite; Manisha, Karpe; Vilasrao, Kadam

2016-01-01

Molecularly imprinted polymers (MIP) are novel carriers synthesized by imprinting of a template over a polymer. This paper presents the recent application of MIP for diagnostic and therapeutic drug delivery. MIP owing to their 3D polymeric structures and due to bond formation with the template serves as a reservoir of active causing stimuli sensitive, enantioselective, targetted and/or controlled release. The review elaborates about key factors for optimization of MIP, controlled release by MIP for various administration routes various forms like patches, contact lenses, nanowires along with illustrations. To overcome the limitation of organic solvent usage causing increased cost, water compatible MIP and use of supercritical fluid technology for molecular imprinting were developed. Novel methods for developing water compatible MIP like pickering emulsion polymerization, co-precipitation method, cyclodextrin imprinting, surface grafting, controlled/living radical chain polymerization methods are described with illustration in this review. Various protein imprinting methods like bulk, epitope and surface imprinting are described along with illustrations. Further, application of MIP in microdevices as biomimetic sensing element for personalized therapy is elaborated. Although development and application of MIP in drug delivery is still at its infancy, constant efforts of researchers will lead to a novel intelligent drug delivery with commercial value. Efforts should be directed in developing solid oral dosage forms consisting of MIP for therapeutic protein and peptide delivery and targeted release of potent drugs addressing life threatening disease like cancer. Amalgamation of bio-engineering and pharmaceutical techniques can make these future prospects into reality.

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

Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis

Science.gov (United States)

Gurung, Vinita; Williamson, Catherine; Chappell, Lucy; Chambers, Jenny; Briley, Annette; Pipkin, Fiona Broughton; Thornton, Jim

2009-01-01

Background Obstetric cholestasis (OC) is a serious problem in pregnancy. It affects about 4500 women per year in the UK. Affected women develop itching and occasionally jaundice. More importantly, the condition is associated with premature delivery, fetal distress and is believed to be an important cause of stillbirth. However, even now, there is no clear evidence as to whether the most popular treatment, a drug called ursodeoxycholic acid is beneficial to the baby, or even if it is safe in pregnancy. Nor do we know whether planned early delivery of the baby at 37–38 weeks, another popular treatment, does more good than harm. A randomised trial to evaluate both ursodeoxycholic acid and timed delivery is needed but will be complicated and expensive. We plan a preliminary study, Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis (Acronym PITCH- Pregnancy Intervention Trial in Cholestasis) trial, to evaluate the feasibility of a larger trial. The trial is funded by the NHS Research for Patient Benefit (RfPB) Programme. Methods PITCH is a multi-centre, double blinded, randomised, controlled, factorial design trial. The trial is being run in six UK centres and women with obstetric cholestasis will be recruited for eighteen months. In this pilot trial we aim to collect data to finalise the design for the main trial. This will include measuring trial recruitment rate, including recruitment to each factorial comparison separately. We will also measure the spectrum of disease among recruits and non-recruits and compliance with the four possible treatment allocations. We will use these data to design the main trial. Discussion The ultimate aim of the main trial is to enable clinicians to manage this condition more effectively. If it transpires that ursodeoxycholic acid and early delivery are both safe and effective then steps will be taken to ensure that all women with OC who could benefit from them receives this treatment

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.

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

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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

Mode of delivery has an independent impact on neonatal condition at birth.

Science.gov (United States)

Prior, Tomas; Kumar, Sailesh

2014-10-01

Current intra-partum monitoring techniques are often criticized for their poor specificity, with their performance frequently evaluated using measures of the neonatal condition at birth as a surrogate marker for intra-partum fetal compromise. However, these measures may potentially be influenced by a multitude of other factors, including the mode of delivery itself. This study aimed to investigate the impact of mode of delivery on neonatal condition at birth. This prospective observational study, undertaken at a tertiary referral maternity unit in London, UK, included 604 'low risk' women recruited prior to delivery. Commonly assessed neonatal outcome variables (Apgar score at 1 and 5min, umbilical artery pH and base excess, neonatal unit admission, and a composite neonatal outcome score) were used to compare the condition at birth between babies born by different modes of delivery, using one-way ANOVA and chi-squared testing. Infants born by instrumental delivery for presumed fetal compromise had the poorest condition at birth (mean composite score=1.20), whereas those born by Cesarean section for presumed fetal compromise had a better condition at birth (mean composite score=0.64) (p=surrogate marker of intra-partum fetal compromise. When evaluating the efficacy of intra-partum monitoring techniques, the isolated use of Apgar scores, umbilical artery acidosis and neonatal unit admission should be discouraged. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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, 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

[Operative vaginal deliveries training].

Science.gov (United States)

Dupuis, O

2008-12-01

The appropriate use of forceps, vacuums or spatulas facilitates the rapid delivery of foetuses faced with life-threatening situations. It also makes possible the relief of certain cases of prolonged second-stage labor. In France, operative vaginal delivery (OVD) accounts for approximately 10% of all births. OVD training aims to optimize maternal, as well as neonatal safety. It should enable trainees to indicate or contraindicate an OVD safely, as well as to choose the appropriate instrument, use it correctly, and master quality control principles. Traditional OVD training is confronted with both spatial and time-related limitations. Spatial constraints involve both the teacher and trainee who only have limited visual access to the pelvic canal, and the head of the foetus; the time constraint occurs whenever the OVD occurs in an emergency setting. These limitations have been further aggravated by new constraints: decreasing time dedicated to training (European safety rules prohibit work the day after night duty), increasing litigation, and constraints imposed by society. Training by means of simulation removes such limitations making it possible to both avoid exposing pregnant women to the hazards of traditional training, and adapt the training to the skills of each trainee. OVD training should include forceps, vacuums and the use of spatulas. The OVD skills of obstetricians should be audited regularly on both a personal and a confidential level. Such audits could be based on a method using a simulator. Prospective studies comparing traditional and simulation-based training should be encouraged.

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

Retention of Vaginal Breech Delivery Skills Taught in Simulation.

Science.gov (United States)

Stone, Heather; Crane, Joan; Johnston, Kathy; Craig, Catherine

2018-02-01

The optimal frequency of conducting simulation training for high-acuity, low-frequency events in obstetrics and gynaecology residency programs is unknown. This study evaluated retention over time of vaginal breech delivery skills taught in simulation, by comparing junior and senior residents. In addition, the residents' subjective comfort level to perform this skill clinically was assessed. This prospective cohort study included 22 obstetrics and gynaecology residents in a Canadian residency training program. Digital recordings were completed for pre-training, immediate post-training, and delayed (10-26 weeks later) post-training intervals of a vaginal breech delivery simulation, with skill assessment by a blinded observer using a binary checklist. Residents also completed questionnaires to assess their subjective comfort level at each interval. Junior and senior residents had significant improvements in vaginal breech delivery skills from the pre-training assessment to both the immediate post-training assessment (junior, P simulation 10-26 weeks later, although a decline in skills occurred over this time period. Comfort level was positively affected and retained. These results will aid in determining the frequency of simulation teaching for high-acuity, low-frequency events in a residency simulation curriculum. Copyright © 2018 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

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

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

Peptide and protein delivery using new drug delivery systems.

Science.gov (United States)

Jain, Ashish; Jain, Aviral; Gulbake, Arvind; Shilpi, Satish; Hurkat, Pooja; Jain, Sanjay K

2013-01-01

Pharmaceutical and biotechnological research sorts protein drug delivery systems by importance based on their various therapeutic applications. The effective and potent action of the proteins/peptides makes them the drugs of choice for the treatment of numerous diseases. Major research issues in protein delivery include the stabilization of proteins in delivery devices and the design of appropriate target-specific protein carriers. Many efforts have been made for effective delivery of proteins/peptidal drugs through various routes of administrations for successful therapeutic effects. Nanoparticles made of biodegradable polymers such as poly lactic acid, polycaprolactone, poly(lactic-co-glycolic acid), the poly(fumaric-co-sebacic) anhydride chitosan, and modified chitosan, as well as solid lipids, have shown great potential in the delivery of proteins/peptidal drugs. Moreover, scientists also have used liposomes, PEGylated liposomes, niosomes, and aquasomes, among others, for peptidal drug delivery. They also have developed hydrogels and transdermal drug delivery systems for peptidal drug delivery. A receptor-mediated delivery system is another attractive strategy to overcome the limitation in drug absorption that enables the transcytosis of the protein across the epithelial barrier. Modification such as PEGnology is applied to various proteins and peptides of the desired protein and peptides also increases the circulating life, solubility and stability, pharmacokinetic properties, and antigenicity of protein. This review focuses on various approaches for effective protein/peptidal drug delivery, with special emphasis on insulin delivery.

An emerging integration between ionic liquids and nanotechnology: general uses and future prospects in drug delivery.

Science.gov (United States)

de Almeida, Tânia Santos; Júlio, Ana; Mota, Joana Portugal; Rijo, Patrícia; Reis, Catarina Pinto

2017-06-01

There is a growing need to develop drug-delivery systems that overcome drawbacks such as poor drug solubility/loading/release, systemic side effects and limited stability. Ionic liquids (ILs) offer many advantages and their tailoring represents a valuable tuning tool. Nano-based systems are also prized materials that prevent drug degradation, enhance their transport/distribution and extend their release. Consequently, structures containing ILs and nanoparticles (NPs) have been developed to attain synergistic effects. This overview on the properties of ILs, NPs and of their combined structures, reveals the recent advances in these areas through a review of pertinent literature. The IL-NP structures present enhanced properties and the subsequent performance upgrade proves to be useful in drug delivery, although much is yet to be done.

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.

Does the baricity of bupivacaine influence intrathecal spread in the prolonged sitting position before elective cesarean delivery? A prospective randomized controlled study.

Science.gov (United States)

Loubert, Christian; Hallworth, Stephen; Fernando, Roshan; Columb, Malachy; Patel, Nisa; Sarang, Kavita; Sodhi, Vinnie

2011-10-01

Difficulties in inserting an epidural catheter while performing combined spinal-epidural anesthesia for cesarean delivery may lead to undue delays between the spinal injection of the local anesthetic mixture and the adoption of the supine position with lateral tilt. We hypothesized that this delay may affect the intrathecal distribution of local anesthetic of different baricities such that hypobaric local anesthetic would lead to a higher sensory block level. Healthy parturients with uncomplicated pregnancies undergoing elective cesarean delivery under combined spinal-epidural anesthesia were enrolled in this prospective double-blind randomized controlled trial. The subjects were allocated to receive hyperbaric (hyperbaric group), isobaric (isobaric group), or hypobaric (hypobaric group) spinal bupivacaine 10 mg. After the spinal injection, the subjects remained in the sitting position for 5 minutes (to simulate difficulty in inserting the epidural catheter) before being helped into the supine lateral tilt position. The primary outcome was the sensory block level during the 25 minutes after the spinal injection. Other end points included motor block score, maternal hypotension, and vasopressor requirements. Data from 89 patients were analyzed. Patient characteristics were similar in all groups. The median [interquartile range] (95% confidence interval) sensory levels after spinal injection were significantly higher with decreasing baricity: hyperbaric T10 [T11-8] (T10-9), isobaric T9 [T10-7] (T9-7), and hypobaric T6 [T8-4] (T8-5) (P hypobaric group reached a sensory block level of T4 at 25 minutes after spinal injection compared with 80% of the patients in both the isobaric and hyperbaric groups (P = 0.04; difference 20%, 95% confidence interval of difference 4%-33%). Significantly more patients in the hypobaric group had complete lower limb motor block (Bromage score = 4) (hyperbaric 43%, isobaric 63%, and hypobaric 90%; P hypobaric groups by factors of 1.83 and 3

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.

Recent Advances in Non-viral Vectors for Gene Delivery

Science.gov (United States)

Guo, Xia; Huang, Leaf

2011-01-01

membrane/core nanoparticles for nucleic acid delivery and ultrasound-responsive nucleic acid vectors. The systemic delivery studies are highlighted. Finally, we bring forward the prospect for nucleic acid delivery. We think a better understandings of the fate of the nanoparticles inside the cell and of the interactions between the parts of hybrid particles will lead to a delivery system suitable for clinical use. We also underscore the value of sustained release of nucleic acid and presume making vectors targeted to cells with sustained release in vivo should be an interesting research challenge. PMID:21870813

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.

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

Nanodiamonds as novel nanomaterials for biomedical applications: drug delivery and imaging systems.

Science.gov (United States)

Kaur, Randeep; Badea, Ildiko

2013-01-01

Detonation nanodiamonds (NDs) are emerging as delivery vehicles for small chemical drugs and macromolecular biotechnology products due to their primary particle size of 4 to 5 nm, stable inert core, reactive surface, and ability to form hydrogels. Nanoprobe technology capitalizes on the intrinsic fluorescence, high refractive index, and unique Raman signal of the NDs, rendering them attractive for in vitro and in vivo imaging applications. This review provides a brief introduction of the various types of NDs and describes the development of procedures that have led to stable single-digit-sized ND dispersions, a crucial feature for drug delivery systems and nanoprobes. Various approaches used for functionalizing the surface of NDs are highlighted, along with a discussion of their biocompatibility status. The utilization of NDs to provide sustained release and improve the dispersion of hydrophobic molecules, of which chemotherapeutic drugs are the most investigated, is described. The prospects of improving the intracellular delivery of nucleic acids by using NDs as a platform are exemplified. The photoluminescent and optical scattering properties of NDs, together with their applications in cellular labeling, are also reviewed. Considering the progress that has been made in understanding the properties of NDs, they can be envisioned as highly efficient drug delivery and imaging biomaterials for use in animals and humans.

Delivery presentations

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Pregnancy - delivery presentation; Labor - delivery presentation; Occiput posterior; Occiput anterior; Brow presentation ... The mother can walk, rock, and try different delivery positions during labor to help encourage the baby ...

New labor management guidelines and changes in cesarean delivery patterns.

Science.gov (United States)

Rosenbloom, Joshua I; Stout, Molly J; Tuuli, Methodius G; Woolfolk, Candice L; López, Julia D; Macones, George A; Cahill, Alison G

2017-12-01

In 2010 the Consortium on Safe Labor published labor curves. It was proposed that the rate of cesarean delivery could be lowered by avoiding the diagnosis of arrest of dilation before 6 cm. However, there is little information on the uptake of the guidelines and on changes in cesarean delivery rates that may have occurred. The objective of the study was to test the following hypotheses: (1) among patients laboring at term, rates of arrest of dilation disorders have decreased, leading to a decrease in the rate of cesarean delivery; (2) in the second stage, pushing duration prior to diagnosis of arrest of descent has increased, also leading to a reduction in the rate of cesarean delivery for this indication. As a secondary aim, we investigated changes in maternal and neonatal morbidity. This was a secondary analysis of a prospective cohort study of all patients presenting at ≥37 weeks' gestation from 2010 through 2014 with a nonanomalous vertex singleton and no prior history of cesarean delivery. Rates of cesarean delivery, arrest of dilation, and changes in rates of maternal and neonatal morbidity were calculated in crude and adjusted models. Cervical dilation at diagnosis of the arrest of dilation, time spent at the maximal dilation prior to diagnosis of arrest of dilation, and time in the second stage prior to the diagnosis of arrest of descent were compared over the study period. There were 7845 eligible patients. The cesarean delivery rate in 2010 was 15.8% and, in 2014, 17.7% (P trend = .51). In patients undergoing cesarean delivery for the arrest of dilation, the median cervical dilation at the time of cesarean delivery was at 5.5 cm in 2010 and 6.0 cm in 2014 (P trend = .94). In these patients, there was an increase in the time spent at last dilation: 3.8 hours in 2010 to 5.2 hours in 2014 (P trend = .02). There was no change in the frequency of patients diagnosed with the arrest of dilation at labor management that have occurred over the initial years

Prenatal ultrasound diagnosis and outcome of placenta previa accreta after cesarean delivery: a systematic review and meta-analysis.

Science.gov (United States)

Jauniaux, Eric; Bhide, Amar

2017-07-01

Women with a history of previous cesarean delivery, presenting with a placenta previa, have become the largest group with the highest risk for placenta previa accreta. The objective of the study was to evaluate the accuracy of ultrasound imaging in the prenatal diagnosis of placenta accreta and the impact of the depth of villous invasion on management in women presenting with placenta previa or low-lying placenta and with 1 or more prior cesarean deliveries. We searched PubMed, Google Scholar, clinicalTrials.gov, and MEDLINE for studies published between 1982 and November 2016. Criteria for the study were cohort studies that provided data on previous mode of delivery, placenta previa, or low-lying placenta on prenatal ultrasound imaging and pregnancy outcome. The initial search identified 171 records, of which 5 retrospective and 9 prospective cohort studies were eligible for inclusion in the quantitative analysis. The studies were scored on methodological quality using the Quality Assessment of Diagnostic Accuracy Studies tool. The 14 cohort studies included 3889 pregnancies presenting with placenta previa or low-lying placenta and 1 or more prior cesarean deliveries screened for placenta accreta. There were 328 cases of placenta previa accreta (8.4%), of which 298 (90.9%) were diagnosed prenatally by ultrasound. The incidence of placenta previa accreta was 4.1% in women with 1 prior cesarean and 13.3% in women with ≥2 previous cesarean deliveries. The pooled performance of ultrasound for the antenatal detection of placenta previa accreta was higher in prospective than retrospective studies, with a diagnostic odds ratios of 228.5 (95% confidence interval, 67.2-776.9) and 80.8 (95% confidence interval, 13.0-501.4), respectively. Only 2 studies provided detailed data on the relationship between the depth of villous invasion and the number of previous cesarean deliveries, independently of the depth of the villous invasion. A cesarean hysterectomy was performed in

Delivery by caesarean section and risk of childhood obesity: analysis of a Peruvian prospective cohort

Directory of Open Access Journals (Sweden)

Rodrigo M. Carrillo-Larco

2015-06-01

Full Text Available Objectives. We aimed to assess if Caesarean section is a risk factor for overnutrition in early- and late-childhood, and to assess the magnitude of the effect of child- versus family-related variables in these risk estimates.Methods. Longitudinal data from Peruvian children from the Young Lives Study was used. Outcomes assessed were overweight, obesity, overnutrition (overweight plus obesity, and central obesity (waist circumference at the age 5 (first follow-up and 7 (second follow-up years. The exposure of interests was delivery by Caesarean section. Relative risks (RR and 95% confidence intervals (95% CI were calculated using multivariable models adjusted for child-related (e.g., birth weight and family-related (e.g., maternal nutritional status variables.Results. At baseline, mean age was 11.7 (± 3.5 months and 50.1% were boys. Children born by Caesarean section were 15.6%. The 10.5% of the children were overweight and 2.4% were obese. For the obesity outcome, data from 6,038 and 9,625 children-years was included from baseline to the first and second follow-up, respectively. Compared to those who did not experience Caesarean delivery, the risk of having obesity was higher in the group born by Caesarean: RRs were higher at early-childhood (first follow-up: 2.25; 95% CI [1.36–3.74] than later in life (second follow-up: 1.57; 95% CI [1.02–2.41]. Family-related variables had a greater effect in attenuating the risk estimates for obesity at the first, than at the second follow-up.Conclusion. Our results suggest a higher probability of developing obesity, but not overweight, among children born by Caesarean section delivery. The magnitude of risk estimates decreased over time, and family-related variables had a stronger effect on the risk estimates at early-childhood.

Delivery by caesarean section and risk of childhood obesity: analysis of a Peruvian prospective cohort.

Science.gov (United States)

Carrillo-Larco, Rodrigo M; Miranda, J Jaime; Bernabé-Ortiz, Antonio

2015-01-01

Objectives. We aimed to assess if Caesarean section is a risk factor for overnutrition in early- and late-childhood, and to assess the magnitude of the effect of child- versus family-related variables in these risk estimates. Methods. Longitudinal data from Peruvian children from the Young Lives Study was used. Outcomes assessed were overweight, obesity, overnutrition (overweight plus obesity), and central obesity (waist circumference) at the age 5 (first follow-up) and 7 (second follow-up) years. The exposure of interests was delivery by Caesarean section. Relative risks (RR) and 95% confidence intervals (95% CI) were calculated using multivariable models adjusted for child-related (e.g., birth weight) and family-related (e.g., maternal nutritional status) variables. Results. At baseline, mean age was 11.7 (± 3.5) months and 50.1% were boys. Children born by Caesarean section were 15.6%. The 10.5% of the children were overweight and 2.4% were obese. For the obesity outcome, data from 6,038 and 9,625 children-years was included from baseline to the first and second follow-up, respectively. Compared to those who did not experience Caesarean delivery, the risk of having obesity was higher in the group born by Caesarean: RRs were higher at early-childhood (first follow-up: 2.25; 95% CI [1.36-3.74]) than later in life (second follow-up: 1.57; 95% CI [1.02-2.41]). Family-related variables had a greater effect in attenuating the risk estimates for obesity at the first, than at the second follow-up. Conclusion. Our results suggest a higher probability of developing obesity, but not overweight, among children born by Caesarean section delivery. The magnitude of risk estimates decreased over time, and family-related variables had a stronger effect on the risk estimates at early-childhood.

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

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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.

Vacuum delivery at The Maternity Hospital Kuala Lumpur: a comparison of metal and silicone cups.

Science.gov (United States)

Lee, H Y; Subramaniam, N; Nordin, M M

1996-02-01

To compare the advantages and disadvantages of the New Bird metal cups and silicone cups in terms of maternal and foetal outcome. To study the adverse effects and factors associated with failed vacuum deliveries. A prospective randomised study of all vacuum deliveries from 1 December 1991 to 31 April 1992. The Hanshin electrical vacuum pump was used. A large obstetric unit-The Maternity Hospital Kuala Lumpur (MHKL). Seventy-two consecutive patients where vacuum deliveries were indicated. Forty had metal and 32 had silicone cups. Another 7 vacuum deliveries using the manual vacuum pump were excluded. Success rate of vaginal delivery, birth canal injuries, post-partum haemorrhage, duration of hospital stay, Apgar score, foetal injuries (scalp-ecchymosis, haematomas) neonatal jaundice, the rate of special care nursery (SCN) admission and neonatal mortality rate. Failure to deliver with silicone cups alone was 21.9% compared to 10% for metal cups alone. Material morbidities and serious foetal scalp injuries were almost the same in both cups. However, minor foetal scalp injuries were significantly lower with silicone cups. Maternal height and baby's weight had no independent predictive values for successful vacuum delivery. When the foetal head was palpable per abdomen, the failure rate was 54.5% compared to 8.2% when it was not. Failed vacuum deliveries were associated with increased maternal and foetal morbidities. Silicone cups and metal cups can be equally dangerous to the baby. Although our sample size was small, we recommend that vacuum delivery be avoided if the foetal head is palpable per abdomen.

Risk Factors Associated with Preterm Delivery after Fetoscopic Laser Surgery for Twin Twin Transfusion Syndrome

Science.gov (United States)

PAPANNA, Ramesha; BLOCK-ABRAHAM, Dana; Mann, Lovepreet K; BUHIMSCHI, Irina A.; BEBBINGTON, Michael; GARCIA, Elisa; KAHLEK, Nahla; HARMAN, Christopher; JOHNSON, Anthony; BASCHAT, Ahmet; MOISE, Kenneth J.

2014-01-01

OBJECTIVE Despite improved perinatal survival following fetoscopic laser surgery (FLS) for twin twin transfusion syndrome (TTTS), prematurity remains an important contributor to perinatal mortality and morbidity. The objective of the study was to identify risk factors for complicated preterm delivery after FLS. STUDY DESIGN Retrospective cohort study of prospectively collected data on maternal/fetal demographics and pre-operative, operative and post-operative variables of 459 patients treated in 3 U.S. fetal centers. Multivariate linear regression was performed to identify significant risk factors associated with preterm delivery, which was cross-validated using K-fold method. Multivariate logistic regression was performed to identify risk factors for early vs. late preterm delivery based on median gestational age at delivery of 32 weeks. RESULTS There were significant differences in case selection and outcomes between the centers. After controlling for the center of surgery, a multivariate analysis indicated a lower maternal age at procedure, history of previous prematurity, shortened cervical length, use of amnioinfusion, 12 Fr cannula diameter, lack of a collagen plug placement and iatrogenic preterm premature rupture of membranes (iPPROM) were significantly associated with a lower gestational age at delivery. CONCLUSION Specific fetal/maternal and operative variables are associated with preterm delivery after FLS for the treatment of TTTS. Further studies to modify some of these variables may decrease the perinatal morbidity after laser therapy. PMID:24013922

Innovative polymeric system (IPS) for solvent-free lipophilic drug transdermal delivery via dissolving microneedles.

Science.gov (United States)

Dangol, Manita; Yang, Huisuk; Li, Cheng Guo; Lahiji, Shayan Fakhraei; Kim, Suyong; Ma, Yonghao; Jung, Hyungil

2016-02-10

Lipophilic drugs are potential drug candidates during drug development. However, due to the need for hazardous organic solvents for their solubilization, these drugs often fail to reach the pharmaceutical market, and in doing so highlight the importance of solvent free systems. Although transdermal drug delivery systems (TDDSs) are considered prospective safe drug delivery routes, a system involving lipophilic drugs in solvent free or powder form has not yet been described. Here, we report, for the first time, a novel approach for the delivery of every kind of lipophilic drug in powder form based on an innovative polymeric system (IPS). The phase transition of powder form of lipophilic drugs due to interior chemical bonds between drugs and biodegradable polymers and formation of nano-sized colloidal structures allowed the fabrication of dissolving microneedles (DMNs) to generate a powerful TDDS. We showed that IPS based DMN with powder capsaicin enhances the therapeutic effect for treatment of the rheumatic arthritis in a DBA/1 mouse model compared to a solvent-based system, indicating the promising potential of this new solvent-free platform for lipophilic drug delivery. Copyright © 2016 Elsevier B.V. All rights reserved.

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

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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.

Prospective risk of fetal death in uncomplicated monochorionic twins.

LENUS (Irish Health Repository)

Farah, Nadine

2012-03-01

A retrospective cohort study was carried out in a university teaching hospital to determine the prospective risk of unexpected fetal death in uncomplicated monochorionic diamniotic (MCDA) twin pregnancies after viability. All MCDA twins delivered at or after 24 weeks\\' gestation from July 1999 to July 2007 were included. Pregnancies with twin-twin transfusion syndrome, growth restriction, structural abnormalities, or twin reversed arterial perfusion sequence were excluded. Of the 144 MCDA twin pregnancies included in our analysis, the risk of intrauterine death was 4.9%. The prospective risk of unexpected intrauterine death was 1 in 43 after 32 weeks\\' gestation and 1 in 37 after 34 weeks\\' gestation. Our results demonstrate that despite close surveillance, the unexpected intrauterine death rate in uncomplicated MCDA twin pregnancies is high. This rate seems to increase after 34 weeks\\' gestation, suggesting that a policy of elective preterm delivery warrants evaluation.

Drug delivery with topically applied nanoparticles: science fiction or reality.

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Lademann, J; Richter, H; Meinke, M C; Lange-Asschenfeldt, B; Antoniou, C; Mak, W C; Renneberg, R; Sterry, W; Patzelt, A

2013-01-01

The efficacy of topically applied drugs is determined by their action mechanism and their potential capacity of passing the skin barrier. Nanoparticles are assumed to be efficient carrier systems for drug delivery through the skin barrier. For flexible nanoparticles like liposomes, this effect has been well demonstrated. The penetration properties of solid nanoparticles are currently under intensive investigation. The crucial advantage of nanoparticles over non-particulate substances is their capability to penetrate deeply into the hair follicles where they can be stored for several days. There is no evidence, yet, that solid particles ≥40 nm are capable of passing through the healthy skin barrier. Therefore and in spite of the long-standing research efforts in this field, commercially available solid nanoparticle-based products for drug delivery through the healthy skin are still missing. Nevertheless, the prospects for the clinical use of nanoparticles in drug delivery are tremendous. They can be designed as transport systems delivering drugs efficiently into the hair follicles in the vicinity of specific target structures. Once deposited at these structures, specific signals might trigger the release of the drugs and exert their effects on the target cells. In this article, examples of such triggered drug release are presented. © 2013 S. Karger AG, Basel.

Transdermal drug delivery

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Prausnitz, Mark R.; Langer, Robert

2009-01-01

Transdermal drug delivery has made an important contribution to medical practice, but has yet to fully achieve its potential as an alternative to oral delivery and hypodermic injections. First-generation transdermal delivery systems have continued their steady increase in clinical use for delivery of small, lipophilic, low-dose drugs. Second-generation delivery systems using chemical enhancers, non-cavitational ultrasound and iontophoresis have also resulted in clinical products; the ability of iontophoresis to control delivery rates in real time provides added functionality. Third-generation delivery systems target their effects to skin’s barrier layer of stratum corneum using microneedles, thermal ablation, microdermabrasion, electroporation and cavitational ultrasound. Microneedles and thermal ablation are currently progressing through clinical trials for delivery of macromolecules and vaccines, such as insulin, parathyroid hormone and influenza vaccine. Using these novel second- and third-generation enhancement strategies, transdermal delivery is poised to significantly increase impact on medicine. PMID:18997767

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

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

Heel pressure ulcer, prevention and predictors during the care delivery chain - when and where to take action? A descriptive and explorative study.

Science.gov (United States)

Muntlin Athlin, Åsa; Engström, Maria; Gunningberg, Lena; Bååth, Carina

2016-11-14

Hazardous healthcare settings, for example acute care, need to focus more on preventing adverse events and preventive actions across the care delivery chain (i.e pre-hospital and emergency care, and further at the hospital ward) should be more studied. Pressure ulcer prevalence is still at unreasonably high levels, causing increased healthcare costs and suffering for patients. Recent biomedical research reveals that the first signs of cell damage could arise within minutes. However, few studies have investigated optimal pressure ulcer prevention in the initial stage of the care process, e.g. in the ambulance care or at the emergency department. The aim of the study was to describe heel pressure ulcer prevalence and nursing actions in relation to pressure ulcer prevention during the care delivery chain, for older patients with neurological symptoms or reduced general condition. Another aim was to investigate early predictors for the development of heel pressure ulcer during the care delivery chain. Existing data collected from a multi-centre randomized controlled trial investigating the effect of using a heel prevention boot to reduce the incidence of heel pressure ulcer across the care delivery chain was used. Totally 183 patients participated. The settings for the study were five ambulance stations, two emergency departments and 16 wards at two hospitals in Sweden. A total of 39 individual patients (21 %) developed heel pressure ulcer at different stages across the care delivery chain. Findings revealed that 47-64 % of the patients were assessed as being at risk for developing heel pressure ulcer. Preventive action was taken. However, all patients who developed pressure ulcer during the care delivery chain did not receive adequate pressure ulcer prevention actions during their hospital stay. In the ambulance and at the emergency department, skin inspection seems to be appropriate for preventing pressure ulcer. However, carrying out risk assessment with a validated

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.

Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial.

Science.gov (United States)

Blanco, Rafael; Ansari, Tarek; Riad, Waleed; Shetty, Nanda

Effective postoperative analgesia after cesarean delivery enhances early recovery, ambulation, and breastfeeding. In a previous study, we established the effectiveness of the quadratus lumborum block in providing pain relief after cesarean delivery compared with patient-controlled analgesia (morphine). In the current study, we hypothesized that this method would be equal to or better than the transversus abdominis plane block with regard to pain relief and its duration of action after cesarean delivery. Between April 2015 and August 2015, we randomized 76 patients scheduled for elective cesarean delivery under spinal anesthesia to receive the quadratus lumborum block or the transversus abdominis plane block for postoperative pain relief. This trial was registered prospectively (NCT 02489851) [corrected]. Patients in the quadratus lumborum block group used significantly less morphine than the transversus abdominis plane block group (P consumption and demands than transversus abdominis plane blocks after cesarean section. This effect was observed up to 48 hours postoperatively.

Assisted Vaginal Delivery

Science.gov (United States)

... Education & Events Advocacy For Patients About ACOG Assisted Vaginal Delivery Home For Patients Search FAQs Assisted Vaginal ... Vaginal Delivery FAQ192, February 2016 PDF Format Assisted Vaginal Delivery Labor, Delivery, and Postpartum Care What is ...

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

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.

Nanopreparations for mitochondria targeting drug delivery system: Current strategies and future prospective

Directory of Open Access Journals (Sweden)

Zhenjie Wang

2017-11-01

Full Text Available Mitochondria are a novel and promising therapeutic target for diagnosis, treatment and prevention of a lot of human diseases such as cancer, metabolic diseases and neurodegenerative disease. Owing to the mitochondrial special bilayer structure and highly negative potential nature, therapeutic molecules have multiple difficulties in reaching mitochondria. To overcome multiple barriers for targeting mitochondria, the researchers developed various pharmaceutical preparations such as liposomes, polymeric nanoparticles and inorganic nanoparticles modified by mitochondriotropic moieties like dequalinium (DQA, triphenylphosphonium (TPP, mitochondrial penetrating peptides (MPPs and mitochondrial protein import machinery that allow specific targeting. The targeted formulations exhibited enhanced pharmacological effect and better therapeutic effect than their untargeted counterpart both in vitro and in vivo. Nanocarriers may be used for bio-therapeutic delivery into specific mitochondria that possess a great potential treatment of mitochondria related diseases.

Duration of pregnancy in relation to seafood intake during early and mid pregnancy: prospective cohort

DEFF Research Database (Denmark)

Olsen, S. F; Osterdal, M. L; Salvig, J. D

2006-01-01

We examined the association between exposure to seafood intake during two periods of pregnancy on the one hand and risks of preterm delivery and postterm delivery on the other. In a prospective cohort of 8729 pregnant Danish women, we assessed frequency of fish meals during the first and second.......23-4.61) times in those who never consumed fish (n = 308) vs. those who consumed both fish as main meal and fish in sandwiches at least once per week (n = 785). These measures were similar when fish intake was based solely on intake reported for mid-pregnancy. In the subgroup of women reporting same intake...

Viral Delivery of dsRNA for Control of Insect Agricultural Pests and Vectors of Human Disease: Prospects and Challenges

Directory of Open Access Journals (Sweden)

Anna Kolliopoulou

2017-06-01

Full Text Available RNAi is applied as a new and safe method for pest control in agriculture but efficiency and specificity of delivery of dsRNA trigger remains a critical issue. Various agents have been proposed to augment dsRNA delivery, such as engineered micro-organisms and synthetic nanoparticles, but the use of viruses has received relatively little attention. Here we present a critical view of the potential of the use of recombinant viruses for efficient and specific delivery of dsRNA. First of all, it requires the availability of plasmid-based reverse genetics systems for virus production, of which an overview is presented. For RNA viruses, their application seems to be straightforward since dsRNA is produced as an intermediate molecule during viral replication, but DNA viruses also have potential through the production of RNA hairpins after transcription. However, application of recombinant virus for dsRNA delivery may not be straightforward in many cases, since viruses can encode RNAi suppressors, and virus-induced silencing effects can be determined by the properties of the encoded RNAi suppressor. An alternative is virus-like particles that retain the efficiency and specificity determinants of natural virions but have encapsidated non-replicating RNA. Finally, the use of viruses raises important safety issues which need to be addressed before application can proceed.

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....

Noninvasive delivery systems for peptides and proteins in osteoporosis therapy: a retroperspective.

Science.gov (United States)

Hoyer, Herbert; Perera, Glen; Bernkop-Schnürch, Andreas

2010-01-01

The aim of this review is to provide the reader general and inspiring prospects in various attempts to make noninvasive delivery systems of calcitonin and teriparatide feasible and as convenient as possible. Calcitonin and teriparatide play an important role in both calcium homeostasis and bone remodelling. Currently calcitonin is available as a subcutaneous injection and as a nasal spray whereas teriparatide is administered subcutaneously. In the past few years, an increasing number of articles about drug delivery systems for calcitonin and teriparatide have been published. These delivery systems have been developed to overcome the inherent barriers for the uptake across the diverse membranes on the various routes for protein and peptide delivery. Co-administration of permeation enhancers, mucoadhesive agents, viscosity modifying agents, multifunctional polymers, protease inhibitors as well as encapsulation and chemical modification are utilized in order to improve calcitonin and teriparatide absorption after oral, nasal, pulmonal, or buccal administration. The majority of research groups have been working on the development of formulations based on the encapsulation of molecules in biodegradable and biocompatible polymeric nanoparticles. However these observations are based on data obtained under different experimental conditions. Hence, it is difficult to compare the obtained results in order to draw general conclusions about the most promising characteristics required for oral and nasal formulations for these peptides.

Self-nanoemulsifying drug delivery systems for oral insulin delivery

DEFF Research Database (Denmark)

Li, Ping; Tan, Angel; Prestidge, Clive A

2014-01-01

This study aims at evaluating the combination of self-nanoemulsifying drug delivery systems (SNEDDS) and enteric-coated capsules as a potential delivery strategy for oral delivery of insulin. The SNEDDS preconcentrates, loaded with insulin-phospholipid complex at different levels (0, 2.5 and 10% w...

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.)

The primipara respons based on individual personality type to the intensity of delivery pain

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Gita N Sari

2016-01-01

Full Text Available Delivery period is one of periods that can cause stress to the mother and the fetus. This period is the natural common phenomenon that for some women subjectively can be considered as pain process that can cause simultaneous anxiety and pain. Psychology research has shown that pain is not only connected to physical respond, the culture that teaches and nurtures us also play important role in coping the pain. These two factors shape different personality for each individual. The objective of this study is to find out the primipara respons based on individual personality type to the intensity of delivery pain. The method of this study was analytical method with survey cross sectional approach. The data was collected prospectively from interview and questionnaire in the same time to find out the correlation between individual personality type and the intensity of delivery pain based on inclusive and exclusive period February 1st 2009 to April 30th 2009. The result with chi-square test and spearman rank test showed significant correlation between individual personality type and the intensity of delivery pain (X2= 8,571 ; p = 0,014. There is the negative correlation between extrovert individual personality and intensity of delivery pain (rs= -0,730; p <0,001, and there is the positive correlation between introvert individual personality type and intensity of delivery pain (rs = 0,726; p <0,001. Based on mann whitney, showed significant difference between extrovert personality type and introverts personality type to intensity of delivery pain (Z M-W: 3,050, p: 0,002. Based on chi-square test showed significant correlation between knowledge based on individual personality type to the intensity of delivery pain (X2= 4,418; p = 0,036 The conclusion of these study are the more extrovert individual personality type the less intense the delivery pain would be, the more introvert individual personality type then the more intense delivery pain would be. The

Transdermal drug delivery

OpenAIRE

Prausnitz, Mark R.; Langer, Robert

2008-01-01

Transdermal drug delivery has made an important contribution to medical practice, but has yet to fully achieve its potential as an alternative to oral delivery and hypodermic injections. First-generation transdermal delivery systems have continued their steady increase in clinical use for delivery of small, lipophilic, low-dose drugs. Second-generation delivery systems using chemical enhancers, non-cavitational ultrasound and iontophoresis have also resulted in clinical products; the ability ...

SU-E-T-370: Evaluating Plan Quality and Dose Delivery Accuracy of Tomotherapy SBRT Treatments for Lung Cancer

Energy Technology Data Exchange (ETDEWEB)

Blake, S; Thwaites, D [University of Sydney, Sydney, NSW (Australia); Hansen, C [Odense University Hospital, Odense C (Denmark); Deshpande, S; Phan, P; Franji, I [Liverpool & Macarthur Cancer Therapy Centres, Liverpool, NSW (United Kingdom); Holloway, L [Ingham Institute, Sydney, NSW (Australia)

2015-06-15

Purpose: This study evaluated the plan quality and dose delivery accuracy of stereotactic body radiotherapy (SBRT) helical Tomotherapy (HT) treatments for lung cancer. Results were compared with those previously reported by our group for flattening filter (FF) and flattening filter free (FFF) VMAT treatments. This work forms part of an ongoing multicentre and multisystem planning and dosimetry audit on FFF beams for lung SBRT. Methods: CT datasets and DICOM RT structures delineating the target volume and organs at risk for 6 lung cancer patients were selected. Treatment plans were generated using the HT treatment planning system. Tumour locations were classified as near rib, near bronchial tree or in free lung with prescribed doses of 48Gy/4fr, 50Gy/5fr and 54Gy/3fr respectively. Dose constraints were specified by a modified RTOG0915 protocol used for an Australian SBRT phase II trial. Plan quality was evaluated using mean PTV dose, PTV volume receiving 100% of the prescribed dose (V100%), target conformity (CI=VD100%/VPTV) and low dose spillage (LDS=VD50%/VPTV). Planned dose distributions were compared to those measured using an ArcCheck phantom. Delivery accuracy was evaluated using a gamma-index pass rate of 95% with 3% (of max dose) and 3mm criteria. Results: Treatment plans for all patients were clinically acceptable in terms of quality and accuracy of dose delivery. The following DVH metrics are reported as averages (SD) of all plans investigated: mean PTV dose was 115.3(2.4)% of prescription, V100% was 98.8(0.9)%, CI was 1.14(0.03) and LDS was 5.02(0.37). The plans had an average gamma-index passing rate of 99.3(1.3)%. Conclusion: The results reported in this study for HT agree within 1 SD to those previously published by our group for VMAT FF and FFF lung SBRT treatments. This suggests that HT delivers lung SBRT treatments of comparable quality and delivery accuracy as VMAT using both FF and FFF beams.

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...

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 ...

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.

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).

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

Maternal anxiety disorders predict excessive infant crying: a prospective longitudinal study.

Science.gov (United States)

Petzoldt, Johanna; Wittchen, Hans-Ulrich; Wittich, Julia; Einsle, Franziska; Höfler, Michael; Martini, Julia

2014-09-01

To prospectively examine relations between maternal DSM-IV-TR anxiety and depressive disorders and excessive infant crying. Based on the prospective longitudinal Maternal Anxiety in Relation to Infant Development Study, n=306 expectant mothers were enrolled during early pregnancy and repeatedly interviewed until 16 months post partum. Lifetime and prospective information on maternal anxiety and depressive disorders was assessed via standardised diagnostic interviews (Composite International Diagnostic Interview for Women). Excessive crying (crying for ≥3 h per day on ≥3 days per week for ≥3 weeks) was assessed via Baby-DIPS. During the first 16 months after delivery, n=286 mother-infant dyads were available and included in the analyses. Excessive crying was reported by n=29 mothers (10.1%). Infants of mothers with anxiety disorders prior to pregnancy were at higher risk for excessive crying than infants of mothers without any anxiety disorder prior to pregnancy (OR=2.54, 95% CI 1.11 to 5.78, p=0.027). Risk was even increased when considering additionally incident anxiety disorders until delivery (OR=3.02, 95% CI 1.25 to 7.32, p=0.014) and until 16 months post partum (OR=2.87, 95% CI 1.13 to 7.28, p=0.027). Associations remained stable when adjusting for sociodemographic and perinatal covariates. Maternal depressive disorders prior to pregnancy were not significantly associated with excessive crying in this sample. Maternal lifetime and incident anxiety disorders revealed to be a robust predictor for excessive crying. Thus, early identification and monitoring of women with anxiety disorders is important to identify mother-infant dyads at risk for excessive crying. 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.

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.

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...

Comparison of bilirubin level in term infants born by vaginal delivery and C/S

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Ahmad Shah Farhat

2016-12-01

Full Text Available Background: Given the overriding importance of neonatal jaundice and scarcity of studies on the role of route of delivery on its occurrence, this study aimed to investigate the association between neonatal bilirubin level and the route of delivery (i.e., normal vaginal delivery [NVD] and cesarean section [CS]. Methods: This prospective, cross-sectional study was conducted in 2012 in Imam Reza Hospital of Mashhad, Iran, 2012. In all term infants, who met the inclusion criteria, serum bilirubin level was measured by the bili-test device between the second and seventh days after birth. In cases with skin bilirubin level>5 mg/dl, serum bilirubin was also checked. The collected data were analyzed using SPSS, version 16. Results: A total of 182 neonates were enrolled in the study, 56% of whom were male. The mean bilirubin levels in the NVD and CS groups were 9.4±2.9 mg/dl and 9.8±3.4 mg/dl, respectively (P=0.53. Additionally, comparison of the mean bilirubin levels between the two groups based of demographic characteristics demonstrated no significant differences. Conclusion: This study showed no significant correlation between neonatal jaundice in term infants and the route of delivery.

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.

A multicentre randomized controlled trial of gentle assisted pushing in the upright posture (GAP) or upright posture alone compared with routine practice to reduce prolonged second stage of labour (the Gentle Assisted Pushing study): study protocol.

Science.gov (United States)

Hofmeyr, G Justus; Singata, Mandisa; Lawrie, Theresa; Vogel, Joshua P; Landoulsi, Sihem; Seuc, Armando H; Gülmezoglu, A Metin

2015-12-16

Fundal pressure (pushing on the upper part of the uterus in the direction of the birth canal) is often performed in routine practice, however the benefit and indications for its use are unclear and vigorous pressure is potentially harmful. There is some evidence that it may be applied routinely or to expedite delivery in some situations (e.g. fetal distress or maternal exhaustion), particularly in settings where other methods of achieving delivery (forceps, vacuum) are not available. Gentle assisted pushing (GAP) is an innovative method of applying gentle but steady pressure to the uterine fundus with the woman in an upright posture. This trial aims to evaluate the use of GAP in an upright posture, or upright posture alone, on reducing the mean time of delivery and the associated maternal and neonatal complications in women not having delivered following 15-30 min in the second stage of labour. We will conduct a multicentre, randomized, unblinded, controlled trial with three parallel arms (1:1:1). 1,145 women will be randomized at three hospitals in South Africa. Women will be eligible for inclusion if they are ≥18 years old, nulliparous, gestational age ≥ 35 weeks, have a singleton pregnancy in cephalic presentation and vaginal delivery anticipated. Women with chronic medical conditions or obstetric complications are not eligible. If eligible women are undelivered following 15-30 min in the second stage of labour, they will be randomly assigned to: 1) GAP in the upright posture, 2) upright posture only and 3) routine practice (recumbent/supine posture). The primary outcome is the mean time from randomization to complete delivery. Secondary outcomes include operative delivery, adverse neonatal outcomes, maternal adverse events and discomfort. This trial will establish whether upright posture and/or a controlled method of applying fundal pressure (GAP) can improve labour outcomes for women and their babies. If fundal pressure is found to have a measurable

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.

Self regulated learning trough project base learning on the prospective math teacher

Science.gov (United States)

Laelasari

2018-03-01

Development of planning, strategy, and learning activities is strongly influenced by metacognition ability, knowledge of learning strategy, and understanding of context is the most important thing to be mastered by a prospective teacher. Self-regulation owned by the individual can control behavior, and manipulate a behavior by using the ability of his mind so that individuals can react to their environment. Self-regulation is the basis of the socialization process as it relates to the entire domain of physical, cognitive, social, and emotional development. This research is a qualitative research with research subject of the fourth-semester student of class A, at one of a university in Cirebon City, West Java. In this research, the lecture material discussed is The Development of Teaching Materials, which is the subject matter that must be mastered by prospective teachers, especially teachers of mathematics education. The instrument used is the questionnaire. The results showed that through project based learning, can grow student’s self-regulated learning especially the prospective math teacher, and can be used as an alternative to the delivery of lecture materials.

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

The relationship between maternal insulin-like growth factors 1 and 2 (IGF-1, IGF-2) and IGFBP-3 to gestational age and preterm delivery.

LENUS (Irish Health Repository)

Cooley, Sharon M

2012-02-01

AIMS: To investigate the relationship between levels of insulin-like growth factors 1 and 2 (IGF-1, IGF-2), and insulin-like growth factor binding protein 3 (IGFBP-3) in antenatal maternal serum and gestational age at delivery. METHODS: Prospective cohort study of 1650 low-risk Caucasian women in a London University teaching hospital. Maternal IGF-1, IGF-2 and IGFBP-3 were measured in maternal blood at booking and analyzed with respect to gestational age at delivery. RESULTS: There was no significant association between maternal IGF-1 or IGF-2 and preterm birth (PTB). A significant reduction in mean IGFBP-3 levels was noted with delivery <32 completed weeks (P=0.02). CONCLUSION: Maternal mean IGFBP-3 levels are significantly reduced in cases complicated by delivery <32 completed weeks.

Urinary incontinence during pregnancy and 1 year after delivery in primiparous women compared with a control group of nulliparous women

DEFF Research Database (Denmark)

Hansen, Bent Brandt; Svare, Jens; Viktrup, Lars

2012-01-01

, the prevalence of any type of urinary incontinence in the primiparous group was 32.1%, compared to 13.8% in the control group. Adjusted OR¿=¿3.3 (95%CI¿=¿2.4-4.4). One year after delivery, the prevalence in the primiparous group was 29.3%, compared to 16.6% in the control group. Adjusted OR¿=¿2.5 (95%CI¿=¿1......AIMS: To investigate the impact of the first pregnancy and delivery on the prevalence and types of urinary incontinence during pregnancy and 1 year after delivery. METHODS: The study was a prospective cohort study with a control group. Primiparous women, who delivered in our department from June...... 2003 to July 2005, participated. The women filled out a questionnaire 2-3 days after the delivery and a new questionnaire after 1 year. The questionnaires comprised basic characteristics and symptoms of urinary incontinence. An attempted age-matched control group of nulliparous women was included...

Incidence trends for childhood type 1 diabetes in Europe during 1989-2003 and predicted new cases 2005-20: a multicentre prospective registration study

DEFF Research Database (Denmark)

Patterson, Christopher C; Dahlquist, Gisela G; Gyürüs, Eva

2009-01-01

BACKGROUND: The incidence of type 1 diabetes in children younger than 15 years is increasing. Prediction of future incidence of this disease will enable adequate fund allocation for delivery of care to be planned. We aimed to establish 15-year incidence trends for childhood type 1 diabetes in Eur...

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...

Maternal and neonatal copeptin levels at cesarean section and vaginal delivery.

Science.gov (United States)

Foda, Ashraf A; Abdel Aal, Ibrahim A

2012-12-01

The objective of the study was to measure the copeptin levels in maternal serum and umbilical cord serum at cesarean section and vaginal delivery in normotensive pregnancy and pre-eclamptic women. This was a prospective study at Mansoura University Hospital, Egypt. Ninety cases were included. They were divided into six groups: (1) normal pregnancy near term, as a control group, (2) primiparas who had vaginal delivery, (3) primiparas who had vaginal delivery and mild preeclampsia, (4) elective repeat cesarean section, (5) intrapartum cesarean section for indications other than fetal distress, and (6) intrapartum cesarean section for fetal distress. Serum copeptin concentrations were quantified with an enzyme-linked immunosorbent assay (ELISA). Mean, standard deviation, and paired t-test were used to test for significant change in quantitative data. The vaginal delivery groups had higher levels of maternal serum copeptin than the elective cesarean section group (P<0.01). Higher maternal serum copeptin levels were found in cases with pre-eclampsia as compared with the normotensive cases. The maternal copeptin levels during intrapartum cesarean section were higher than that during elective repeat cesarean section. There was a significant correlation between maternal copeptin levels and the duration of the first stage. In the presence of fetal distress, umbilical cord serum copeptin levels were significantly higher than other groups. Vaginal delivery can be very painful and stressful, and is accompanied by a marked increase of maternal serum copeptin. Increased maternal levels of serum copeptin were found in cases with pre-eclampsia as compared with the normotensive cases, and it may be helpful in assessing the disease. Intrauterine fetal distress is a strong stimulus to the release of copeptin into the fetal circulation. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Nanodiamonds as novel nanomaterials for biomedical applications: drug delivery and imaging systems

Directory of Open Access Journals (Sweden)

Kaur R

2013-01-01

Full Text Available Randeep Kaur, Ildiko BadeaDrug Design and Discovery Research Group, College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, CanadaAbstract: Detonation nanodiamonds (NDs are emerging as delivery vehicles for small chemical drugs and macromolecular biotechnology products due to their primary particle size of 4 to 5 nm, stable inert core, reactive surface, and ability to form hydrogels. Nanoprobe technology capitalizes on the intrinsic fluorescence, high refractive index, and unique Raman signal of the NDs, rendering them attractive for in vitro and in vivo imaging applications. This review provides a brief introduction of the various types of NDs and describes the development of procedures that have led to stable single-digit-sized ND dispersions, a crucial feature for drug delivery systems and nanoprobes. Various approaches used for functionalizing the surface of NDs are highlighted, along with a discussion of their biocompatibility status. The utilization of NDs to provide sustained release and improve the dispersion of hydrophobic molecules, of which chemotherapeutic drugs are the most investigated, is described. The prospects of improving the intracellular delivery of nucleic acids by using NDs as a platform are exemplified. The photoluminescent and optical scattering properties of NDs, together with their applications in cellular labeling, are also reviewed. Considering the progress that has been made in understanding the properties of NDs, they can be envisioned as highly efficient drug delivery and imaging biomaterials for use in animals and humans.Keywords: dispersion, surface functionalization, toxicity, carriers, fluorescence, light scattering

Recent advances on smart TiO2 nanotube platforms for sustainable drug delivery applications

Directory of Open Access Journals (Sweden)

Wang Q

2016-12-01

Full Text Available Qun Wang,1,2,* Jian-Ying Huang,2,* Hua-Qiong Li,3,4 Allan Zi-Jian Zhao,4 Yi Wang,4 Ke-Qin Zhang,2,5 Hong-Tao Sun,1 Yue-Kun Lai,2,5 1College of Chemistry, Chemical Engineering and Materials Science, Soochow University, Suzhou, 2National Engineering Laboratory for Modern Silk, College of Textile and Clothing Engineering, Soochow University, Suzhou, 3Institute of Biomaterials and Engineering, Wenzhou Medical University, 4Wenzhou Institute of Biomaterials and Engineering, Chinese Academy of Sciences, Wenzhou, 5Research Center of Cooperative Innovation for Functional Organic/Polymer Material Micro/Nanofabrication, Suzhou, People’s Republic of China *These authors contributed equally to this work Abstract: To address the limitations of traditional drug delivery, TiO2 nanotubes (TNTs are recognized as a promising material for localized drug delivery systems. With regard to the excellent biocompatibility and physicochemical properties, TNTs prepared by a facile electrochemical anodizing process have been used to fabricate new drug-releasing implants for localized drug delivery. This review discusses the development of TNTs applied in localized drug delivery systems, focusing on several approaches to control drug release, including the regulation of the dimensions of TNTs, modification of internal chemical characteristics, adjusting pore openings by biopolymer coatings, and employing polymeric micelles as drug nanocarriers. Furthermore, rational strategies on external conditions-triggered stimuli-responsive drug release for localized drug delivery systems are highlighted. Finally, the review concludes with the recent advances on TNTs for controlled drug delivery and corresponding prospects in the future. Keywords: TiO2 nanotubes, electrochemical anodization, modification, stimulated drug delivery, drug-releasing implant

A qualitative study to explore Prospect theory and message framing and diet and cancer prevention-related issues among African American adolescents

Science.gov (United States)

Satia, Jessie A.; Barlow, Jameta; Armstrong-Brown, Janelle; Watters, Joanne L.

2010-01-01

Aims To develop and test cancer prevention messages based on Prospect theory on motivation to improve dietary intake in African American adolescents, and to explore other salient factors that may inform dietary intervention design and implementation in this population. Methods Semi-structured in-person qualitative interviews were conducted with 13 African-American male and female adolescents, 12-16 years, in North Carolina. Prospect theory and message framing were used to guide the design of the four sets of diet-related messages related to cancer prevention: short-term gain-, long-term gain-, short-term loss-, and long-term loss-framed messages. Data were also collected on demographic, behavioral, and psychological factors; usual health behaviors; and preferences for intervention delivery. Results The majority of respondents found the gain-framed, short-term messages most salient for both fruits/vegetables (8 (61.5%)), and fat consumption (7 (53.8%)). For fat consumption only, 2 (15.4%) found the loss-framed, short-term messages pertinent; none found the loss-framed, long-term messages relevant for either dietary variable. All indicated interest in participating in a dietary intervention/education program; most preferred the Internet as a channel for intervention delivery. Participants expressed diverse views regarding knowledge, attitudes, and beliefs regarding healthy eating. Conclusions Researchers conducting dietary interventions and education initiatives and medical professionals who counsel African American adolescents should consider using Prospect Theory as a theoretical framework, should focus on gain-framed short-term messages regarding cancer prevention, and should employ the Internet for data collection and intervention and information delivery. PMID:20142738

Vaginal delivery to reduce the risk of hypothermia to newborn

Science.gov (United States)

Zulala, Nuli Nuryanti; Sitaresmi, Mei Neni; Sulistyaningsih

2017-08-01

The prevalence of hypothermia in the world is in the range of 8.5% to 52%, while in Indonesia it is around 47%. Hypothermia has caused 6.3% of neonatal deaths. The method in the process of giving birth determines the way to take care of the newborn. This study aims to observe the effect of the method of delivery on the hypothermia in newborn. This research has obtained an approval from the Ethics Committee of Aisyiyah University, Yogyakarta. This prospective cohort study was conducted to 74 newborns in November 2016. The research subjects were divided into the group of Caesarian section (n = 28) and the group of vaginal delivery (n = 46). Axillary temperature was measured using a digital thermometer at 1st minute, 30th minute, 60th minute, 6th hour, 12th hour and 24th hour. The average temperature difference between the caesarian section group and vaginal delivery group at the 1st minute was at 36°C vs. 36.4° C, at 30th minute at 35.7°C vs. 36.5°C, at 60th minute at 36°C vs. 36.5°C), at 6th hour at 36.2 °C vs. 36.6°C), 12th hour at 36.4°C vs. 36.7°C, and at 24th hour at 36.7°C vs. 36.8°C. The results of the study showed that vaginal delivery could reduce the risk of hypothermia by 1.5 times compared to caesarian section (ρ-value 0.004 CI 95% 1.154 to 1.880)

Risk factors for urinary incontinence 1 year after the first vaginal delivery in a cohort of primiparous Danish women

DEFF Research Database (Denmark)

Svare, Jens A; Hansen, Bent B; Lose, Gunnar

2014-01-01

second questionnaire was filled out 1 year later. Additional data were obtained from the medical records. The first questionnaire was completed by 1,018 women (63 %) and the second by 859 women (84 %). The study group comprised the 575 women without any UI before the pregnancy and who had a vaginal...... delivery. The primary analysis comprised 117 women with either SUI or MUI 1 year after the vaginal delivery and 403 women without any UI. RESULTS: In univariate analyses, the following factors were associated with SUI or MUI: prepregnancy body mass index (BMI) ≥ 30 (p ...INTRODUCTION AND HYPOTHESIS: The objective was to examine the relationship between maternal and perinatal factors and the occurrence of stress (SUI) or mixed (MUI) urinary incontinence (UI) 1 year after the first vaginal delivery in primiparous women. METHODS: Participants in this prospective...

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

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

Prevalence and determinants of pre-term deliveries in the University of Ilorin Teaching Hospital, Ilorin, Nigeria

Directory of Open Access Journals (Sweden)

O. A. Mokuolu

2010-03-01

Full Text Available In Nigeria, over 900,000 children under the age of five years die every year. Early neonatal death is responsible for a little over 20% of these deaths. Prematurity remains a significant cause of these early neonatal deaths. In some series, it is reported to be responsible for 60-70% of these deaths. This study aimed to determine the prevalence and determinants of pre-term deliveries at the University of Ilorin Teaching Hospital, Ilorin. This was a prospective cohort study conducted over a 9-month period at the University of Ilorin Teaching Hospital. Records of deliveries and data on maternal socio-biological and antenatal variables were collected during this period in order to determine the prevalence and determinants of pre-term deliveries. Out of the 2,489 deliveries that took place over a 9-month period, there were 293 pre-terms, giving a pre-term delivery rate of 120 per 1,000 deliveries. Of the total deliveries, 1,522 singleton deliveries that satisfied inclusion criteria were recruited; 185 of them were pre-term deliveries giving a case:control ratio of 1:7. Significant determinants of pre-term delivery identified were previous pre-term delivery (P=0.001; OR=3.55; 95% CI=1.71-7.30, antepartum hemorrhage (P=0.000; OR=8.95; 95%CI=4.06-19.78, premature rupture of the membranes (P=0.000; OR=6.48; 95%CI=4.33-9.67, maternal urinary tract infection (P=0.006; OR=5.89; 95%CI=1.16-27.57, pregnancy induced hypertension (P=0.007; OR=3.23; 95%CI=2.09-4.99, type of labor (P=0.000; OR=6.44; 95%CI=4.42-9.38 and booking status (P=0.000; OR=4.67; 95%CI=3.33-6.56. The prevalence of pre-term delivery was 120 per 1,000 live births. Factors significantly associated with pre-term delivery were low socio-economic class, previous pre-term delivery, antepartum hemorrhage, premature rupture of fetal membranes, urinary tract infection, pregnancy induced hypertension, induced labor, and booking elsewhere outside the teaching hospital.

Predictive modeling of emergency cesarean delivery.

Directory of Open Access Journals (Sweden)

Carlos Campillo-Artero

Full Text Available To increase discriminatory accuracy (DA for emergency cesarean sections (ECSs.We prospectively collected data on and studied all 6,157 births occurring in 2014 at four public hospitals located in three different autonomous communities of Spain. To identify risk factors (RFs for ECS, we used likelihood ratios and logistic regression, fitted a classification tree (CTREE, and analyzed a random forest model (RFM. We used the areas under the receiver-operating-characteristic (ROC curves (AUCs to assess their DA.The magnitude of the LR+ for all putative individual RFs and ORs in the logistic regression models was low to moderate. Except for parity, all putative RFs were positively associated with ECS, including hospital fixed-effects and night-shift delivery. The DA of all logistic models ranged from 0.74 to 0.81. The most relevant RFs (pH, induction, and previous C-section in the CTREEs showed the highest ORs in the logistic models. The DA of the RFM and its most relevant interaction terms was even higher (AUC = 0.94; 95% CI: 0.93-0.95.Putative fetal, maternal, and contextual RFs alone fail to achieve reasonable DA for ECS. It is the combination of these RFs and the interactions between them at each hospital that make it possible to improve the DA for the type of delivery and tailor interventions through prediction to improve the appropriateness of ECS indications.

Prospect of floating desalination facilities using nuclear energy in Indonesia

International Nuclear Information System (INIS)

Rusli, A.; Rina, G.; Gunandjar; Subki, I.R.

1997-01-01

This paper summarizes studies on the water demand and supply problems in Indonesia in the last few years. During the dry season in 1990, it was reported that lack of fresh drinking water in Java and Bali amounted to 2.4 x 10 6 ton/month. Since Indonesia consists of more than 13,000 islands, more problems are faced by other islands. The studies are focused on certain regions (groups of islands) which may have a potential for using a floating desalination facility. Water reservoirs in each island and delivery systems from the floating desalination facilities need to be assessed to see the prospective uses of the systems. Cheap, self-forgiving and easily operated systems, using transportable ship mounted desalination facilities, may be required as a solution to the water supply shortages for these islands. Conclusions based on current problems in water demand and supply and comments on the prospective future market using floating desalination facilities in Indonesia are also given. (author). 9 refs, 10 tabs

Interdelivery weight gain and risk of cesarean delivery following a prior vaginal delivery.

Science.gov (United States)

Dude, Annie M; Lane-Cordova, Abbi D; Grobman, William A

2017-09-01

Approximately one third of all deliveries in the United States are via cesarean. Previous research indicates weight gain during pregnancy is associated with an increased risk of cesarean delivery. It remains unclear, however, whether and to what degree weight gain between deliveries (ie, interdelivery weight gain) is associated with cesarean delivery in a subsequent pregnancy following a vaginal delivery. The objective of the study was to determine whether interdelivery weight gain is associated with an increased risk of intrapartum cesarean delivery following a vaginal delivery. This was a case-control study of women who had 2 consecutive singleton births of at least 36 weeks' gestation between 2005 and 2016, with a vaginal delivery in the index pregnancy. Women were excluded if they had a contraindication to a trial of labor (eg, fetal malpresentation or placenta previa) in the subsequent pregnancy. Maternal characteristics and delivery outcomes for both pregnancies were abstracted from the medical record. Maternal weight gain between deliveries was measured as the change in body mass index at delivery. Women who underwent a subsequent cesarean delivery were compared with those who had a repeat vaginal delivery using χ 2 statistics for categorical variables and Student t tests or analysis of variance for continuous variables. Multivariable logistic regression was used to determine whether interdelivery weight gain remained independently associated with intrapartum cesarean delivery after adjusting for potential confounders. Of 10,396 women who met eligibility criteria and had complete data, 218 (2.1%) had a cesarean delivery in the subsequent pregnancy. Interdelivery weight gain was significantly associated with cesarean delivery and remained significant in multivariable analysis for women with a body mass index increase of at least 2 kg/m 2 (adjusted odds ratio, 1.53, 95% confidence interval, 1.03-2.27 for a body mass index increase of 2 kg/m 2 to gained 2 kg

eDelivery

Data.gov (United States)

US Agency for International Development — eDelivery provides the electronic packaging and delivery of closed and complete OPM investigation files to government agencies, including USAID, in a secure manner....

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 ...

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.

The use of portable video media vs standard verbal communication in the urological consent process: a multicentre, randomised controlled, crossover trial.

Science.gov (United States)

Winter, Matthew; Kam, Jonathan; Nalavenkata, Sunny; Hardy, Ellen; Handmer, Marcus; Ainsworth, Hannah; Lee, Wai Gin; Louie-Johnsun, Mark

2016-11-01

To determine if portable video media (PVM) improves patient's knowledge and satisfaction acquired during the consent process for cystoscopy and insertion of a ureteric stent compared to standard verbal communication (SVC), as informed consent is a crucial component of patient care and PVM is an emerging technology that may help improve the consent process. In this multi-centre randomised controlled crossover trial, patients requiring cystoscopy and stent insertion were recruited from two major teaching hospitals in Australia over a 15-month period (July 2014-December 2015). Patient information delivery was via PVM and SVC. The PVM consisted of an audio-visual presentation with cartoon animation presented on an iPad. Patient satisfaction was assessed using the validated Client Satisfaction Questionnaire 8 (CSQ-8; maximum score 32) and knowledge was tested using a true/false questionnaire (maximum score 28). Questionnaires were completed after first intervention and after crossover. Scores were analysed using the independent samples t-test and Wilcoxon signed-rank test for the crossover analysis. In all, 88 patients were recruited. A significant 3.1 point (15.5%) increase in understanding was demonstrable favouring the use of PVM (P < 0.001). There was no difference in patient satisfaction between the groups as judged by the CSQ-8. A significant 3.6 point (17.8%) increase in knowledge score was seen when the SVC group were crossed over to the PVM arm. A total of 80.7% of patients preferred PVM and 19.3% preferred SVC. Limitations include the lack of a validated questionnaire to test knowledge acquired from the interventions. This study demonstrates patients' preference towards PVM in the urological consent process of cystoscopy and ureteric stent insertion. PVM improves patient's understanding compared with SVC and is a more effective means of content delivery to patients in terms of overall preference and knowledge gained during the consent process. © 2016 The

Effects of natural childbirth preparation versus standard antenatal education on epidural rates, experience of childbirth and parental stress in mothers and fathers: a randomised controlled multicentre trial

Science.gov (United States)

Bergström, M; Kieler, H; Waldenström, U

2009-01-01

Objective To examine the effects of antenatal education focussing on natural childbirth preparation with psychoprophylactic training versus standard antenatal education on the use of epidural analgesia, experience of childbirth and parental stress in first-time mothers and fathers. Design Randomised controlled multicentre trial. Setting Fifteen antenatal clinics in Sweden between January 2006 and May 2007. Sample A total of 1087 nulliparous women and 1064 of their partners. Methods Natural group: Antenatal education focussing on natural childbirth preparation with training in breathing and relaxation techniques (psychoprophylaxis). Standard care group: Standard antenatal education focussing on both childbirth and parenthood, without psychoprophylactic training. Both groups: Four 2-hour sessions in groups of 12 participants during third trimester of pregnancy and one follow-up after delivery. Main outcome measures Epidural analgesia during labour, experience of childbirth as measured by the Wijma Delivery Experience Questionnaire (B), and parental stress measured by the Swedish Parenthood Stress Questionnaire. Results The epidural rate was 52% in both groups. There were no statistically significant differences in the experience of childbirth or parental stress between the randomised groups, either in women or men. Seventy percent of the women in the Natural group reported having used psychoprophylaxis during labour. A minority in the Standard care group (37%) had also used this method, but subgroup analysis where these women were excluded did not change the principal findings. Conclusion Natural childbirth preparation including training in breathing and relaxation did not decrease the use of epidural analgesia during labour, nor did it improve the birth experience or affect parental stress in early parenthood in nulliparous women and men, compared with a standard form of antenatal education. PMID:19538406

The prevalence of very preterm deliveries, risk factors, and neonatal complications in Arash women hospital: a brief report

Directory of Open Access Journals (Sweden)

Abootaleb Beigi

2013-06-01

Full Text Available Background: Very preterm birth (26-32 weeks has an important effect on infant morta-lity and disability of infancy. The aim of this study was to investigate the prevalence of very preterm delivery and early neonatal morbidity (the first 28 days after birth.Methods: In this cross-sectional retrospective study, among 4393 delivery in Arash Women's Hospital in Tehran, 59 deliveries were very preterm that resulted in 79 very preterm neonate births. We assessed maternal risk factors and neonatal complications in women who were admitted for delivery from March 2009 to March 2010.Results: Among 59 pregnant women, 17 (12/27% had multiple pregnancies and 17 (12/27% had premature rupture of fetal membranes. Caesarean section method was more common than normal vaginal delivery (46 cases- 97/77%. Women aged 18 to 35 had the highest rate of preterm delivery (45/86%. Among 79 very preterm neonates about half of them were very low birth weight, 74 neonates (93/67% suffered from respiratory distress syndrome and 13 deaths were reported.Conclusion: Premature birth is a multi-factorial phenomenon. Identifying maternal risk factors and increasing knowledge about it can decrease the rate of preterm labor. The prevention of premature labor is better than cure. Further prospective studies with large number of patients and long-term follow-up are recommended for better understanding of the phenomenon.

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

UAV Delivery Monitoring System

Directory of Open Access Journals (Sweden)

San Khin Thida

2018-01-01

Full Text Available UAV-based delivery systems are increasingly being used in the logistics field, particularly to achieve faster last-mile delivery. This study develops a UAV delivery system that manages delivery order assignments, autonomous flight operation, real time control for UAV flights, and delivery status tracking. To manage the delivery item assignments, we apply the concurrent scheduler approach with a genetic algorithm. The present paper describes real time flight data based on a micro air vehicle communication protocol (MAVLink. It also presents the detailed hardware components used for the field tests. Finally, we provide UAV component analysis to choose the suitable components for delivery in terms of battery capacity, flight time, payload weight and motor thrust ratio.

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.

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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-...

Vaginal Cleansing Before Cesarean Delivery: A Systematic Review and Meta-analysis.

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Caissutti, Claudia; Saccone, Gabriele; Zullo, Fabrizio; Quist-Nelson, Johanna; Felder, Laura; Ciardulli, Andrea; Berghella, Vincenzo

2017-09-01

simple intervention, we recommend preoperative vaginal preparation before cesarean delivery in these women with sponge stick preparation of povidone-iodine 10% for at least 30 seconds. More data are needed to assess whether this intervention may be also useful for cesarean deliveries performed in women not in labor and for those without ruptured membranes. PROSPERO International prospective register of systematic reviews, https://www.crd.york.ac.uk/PROSPERO/, CRD42017054843.

Outcome of deliveries in healthy but obese women: obesity and delivery outcome

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Kaplan-Sturk Rebecka

2013-02-01

Full Text Available Abstract Background Obesity among fertile women is a global problem. 25% of pregnant Swedish women are overweight at admission to the antenatal clinic and 12% of them are considered as obese. Previous studies have shown an increased risk of delivery complications with an elevated maternal BMI. The aim of this study was to evaluate delivery outcomes in relation to maternal BMI on admission to the antenatal clinic. A healthy group of 787 women with full-term pregnancies and spontaneous onset of labor were included in the study. Delivery outcome was assessed in relation to maternal BMI when attending the antenatal clinic. Results The results indicated that in deliveries where the maternal BMI was >30 a high frequency of abnormal CTG trace during the last 30 minutes of labor was shown. A blood sample for evaluation of risk of fetal hypoxia was performed in only eight percent of these deliveries. A spontaneous vaginal delivery without intervention was noted in 85.7%, and 12% of neonates were delivered with an adverse fetal outcome compared to 2.8% in the group with a maternal BMI Conclusion These results indicate an increased risk at delivery for healthy, but obese women in labor. Furthermore, the delivery management may not always be optimal in these deliveries.

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.

Obstetric and neonatal characteristics of pregnancy and delivery for infant birthweight ≥5.0 kg.

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Crosby, David A; Ahmed, Sahar; Razley, Aminah; Morrison, John J

2017-12-01

Infant birthweight ≥5.0 kg represents a significant risk factor for mother and neonate. The objective of this study was to examine the obstetric and neonatal outcome measures in a large cohort of such deliveries. The data used for this study were prospectively entered into an obstetric computerized database during the period 1989-2013. All pregnancies where the delivery resulted in an infant weighing ≥5.0 kg were identified. The results were retrospectively analyzed separately for parity, and a separate analysis was performed comparing the outcome measures observed in the earlier years of the study with those of the later years. There were 73,796 deliveries in the time period of which there were n = 201 (0.3%) infants with birth weight ≥5.0 kg. The mean maternal body mass index (BMI) was in the obese category range (30.9 kg/m 2 ) and the median gestation at delivery was 40.8 weeks. The cesarean delivery rate for nulliparous women was 56.3% and for parous women 30.8%. The overall rate of third degree perineal tears was 3.8%, the rate of shoulder dystocia was 4.6% and the rate of Erb's Palsy was 1.5%. There was a significant increase in cesarean delivery in the latter of the study (26.7% versus 43.0%, p = 0.02), due to an increase in the planned pre-labor cesarean deliveries (30.0 versus 12.9%, p = 0.005). There was no difference in adverse outcomes in both groups. These findings describe the features of pregnancy associated with infant birthweight ≥5.0 kg, and outline reliable maternal and neonatal morbidity data for these pregnancies. In this cohort, there was no apparent benefit from increased planned pre-labor cesarean delivery rates.

Timing of delivery after external cephalic version and the risk for cesarean delivery.

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Kabiri, Doron; Elram, Tamar; Aboo-Dia, Mushira; Elami-Suzin, Matan; Elchalal, Uriel; Ezra, Yossef

2011-08-01

To estimate the association between time of delivery after external cephalic version at term and the risk for cesarean delivery. This retrospective cohort study included all successful external cephalic versions performed in a tertiary center between January 1997 and January 2010. Stepwise logistic regression was used to calculate the odds ratio (OR) for cesarean delivery. We included 483 external cephalic versions in this study, representing 53.1% of all external cephalic version attempts. The incidence of cesarean delivery for 139 women (29%) who gave birth less than 96 hours from external cephalic version was 16.5%; for 344 women (71%) who gave birth greater than 96 hours from external cephalic version, the incidence of cesarean delivery was 7.8% (P = .004). The adjusted OR for cesarean delivery was 2.541 (95% confidence interval 1.36-4.72). When stratified by parity, the risk for cesarean delivery when delivery occurred less than 96 hours after external cephalic version was 2.97 and 2.28 for nulliparous and multiparous women, respectively. Delivery at less than 96 hours after successful external cephalic version was associated with an increased risk for cesarean delivery. III.

Transvaginal cervical length and amniotic fluid index: can it predict delivery latency following preterm premature rupture of membranes?

Science.gov (United States)

Mehra, Suwan; Amon, Erol; Hopkins, Sarah; Gavard, Jeffrey A; Shyken, Jaye

2015-03-01

We sought to determine whether transvaginal cervical length (TVCL), amniotic fluid index (AFI), or a combination of both can predict delivery latency within 7 days in women presenting with preterm premature rupture of membranes (PPROM). This was a prospective observational study of TVCL measurements in 106 singleton pregnancies with PPROM between 23-33 weeks. Delivery latency was defined as the period (in days) from the initial TVCL after PPROM to delivery of the infant, with our primary outcome being delivery within 7 days of TVCL. The independent predictability of significant characteristics for delivery within 7 days was determined using multiple logistic regression. Sensitivity, specificity, and predictive values were used to examine whether the presence of a short TVCL, AFI, or a combination of both affected the risk of delivery within 7 days. Delivery within 7 days occurred in 51/106 (48%) of pregnancies. Median duration (interquartile range) from PPROM to delivery and TVCL to delivery was 8 days (4.0-16.0) and 8 days (3.0-15.0), respectively. Using multiple regression TVCL as a continuous variable (odds ratio, 0.65; 95% confidence interval, 0.44-0.97; P 7 days for TVCL >2 cm alone was 61%. This predictive value changed when analyzed in conjunction with an AFI ≤5 cm and >5 cm at 42% and 89%, respectively. A shorter TVCL and an AFI ≤5 cm independently predict delivery within 7 days in women presenting with PPROM. The combination of an AFI >5 cm and TVCL >2 cm greatly improved the potential to remain undelivered at 7 days following cervical length assessment. These findings may be helpful for counseling and optimizing maternal and neonatal care in women with PPROM. Copyright © 2015 Elsevier Inc. All rights reserved.

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...

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

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.

ISO STANDARD IN THE FIELD OF LEARNING SERVICES AND THE PROSPECT OF ITS APPLICATION IN RUSSIA

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Galina Pankina

2015-11-01

Full Text Available The article considers peculiarities and the prospect of the practical implementation of a rather new standard developed by ISO and adopted in Russia. The objective of ISO 29990:2010 is to provide a generic model for quality professional practice and performance, and a common reference for learning service providers and their clients in the design, development and delivery of non-formal education and training.

Exosomes in Cancer Nanomedicine and Immunotherapy: Prospects and Challenges.

Science.gov (United States)

Syn, Nicholas L; Wang, Lingzhi; Chow, Edward Kai-Hua; Lim, Chwee Teck; Goh, Boon-Cher

2017-07-01

Exosomes (versatile, cell-derived nanovesicles naturally endowed with exquisite target-homing specificity and the ability to surmount in vivo biological barriers) hold substantial promise for developing exciting approaches in drug delivery and cancer immunotherapy. Specifically, bioengineered exosomes are being successfully deployed to deliver potent tumoricidal drugs (siRNAs and chemotherapeutic compounds) preferentially to cancer cells, while a new generation of exosome-based therapeutic cancer vaccines has produced enticing results in early-phase clinical trials. Here, we review the state-of-the-art technologies and protocols, and discuss the prospects and challenges for the clinical development of this emerging class of therapeutics. Copyright © 2017 Elsevier Ltd. All rights reserved.

Prevention of preterm delivery with vaginal progesterone in women with preterm labour (4P): randomised double-blind placebo-controlled trial.

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Martinez de Tejada, B; Karolinski, A; Ocampo, M C; Laterra, C; Hösli, I; Fernández, D; Surbek, D; Huespe, M; Drack, G; Bunader, A; Rouillier, S; López de Degani, G; Seidenstein, E; Prentl, E; Antón, J; Krähenmann, F; Nowacki, D; Poncelas, M; Nassif, J C; Papera, R; Tuma, C; Espoile, R; Tiberio, O; Breccia, G; Messina, A; Peker, B; Schinner, E; Mol, B W; Kanterewicz, L; Wainer, V; Boulvain, M; Othenin-Girard, V; Bertolino, M V; Irion, O

2015-01-01

To evaluate the effectiveness of 200 mg of daily vaginal natural progesterone to prevent preterm birth in women with preterm labour. Multicentre, randomised, double-blind, placebo-controlled trial. Twenty-nine centres in Switzerland and Argentina. A total of 385 women with preterm labour (24(0/7) to 33(6/7) weeks of gestation) treated with acute tocolysis. Participants were randomly allocated to either 200 mg daily of self-administered vaginal progesterone or placebo within 48 hours of starting acute tocolysis. Primary outcome was delivery before 37 weeks of gestation. Secondary outcomes were delivery before 32 and 34 weeks, adverse effects, duration of tocolysis, re-admissions for preterm labour, length of hospital stay, and neonatal morbidity and mortality. The study was ended prematurely based on results of the intermediate analysis. Preterm birth occurred in 42.5% of women in the progesterone group versus 35.5% in the placebo group (relative risk [RR] 1.2; 95% confidence interval [95% CI] 0.93-1.5). Delivery at <32 and <34 weeks did not differ between the two groups (12.9 versus 9.7%; [RR 1.3; 95% CI 0.7-2.5] and 19.7 versus 12.9% [RR 1.5; 95% CI 0.9-2.4], respectively). The duration of tocolysis, hospitalisation, and recurrence of preterm labour were comparable between groups. Neonatal morbidity occurred in 44 (22.8%) cases on progesterone versus 35 (18.8%) cases on placebo (RR: 1.2; 95% CI 0.82-1.8), whereas there were 4 (2%) neonatal deaths in each study group. There is no evidence that the daily administration of 200 mg vaginal progesterone decreases preterm birth or improves neonatal outcome in women with preterm labour. © 2014 Royal College of Obstetricians and Gynaecologists.

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

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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.

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.

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

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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.

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.

Mesoporous persistent nanophosphors for in vivo optical bioimaging and drug-delivery

Science.gov (United States)

Maldiney, Thomas; Ballet, Benoit; Bessodes, Michel; Scherman, Daniel; Richard, Cyrille

2014-10-01

Based upon the ambitious idea that one single particle could serve multiple purposes at the same time, the combination and simultaneous use of imaging and therapeutics has lately arisen as one of the most promising prospects among nanotechnologies directed toward biomedical applications. Intended for both therapeutics and diagnostics in vivo, highly complex nanostructures were specifically designed to simultaneously act as optical imaging probes and delivery vehicles. Yet, such multifunctional photonic nanoplatforms usually exploit fluorescence phenomena which require constant excitation light through biological tissues and thus significantly reduce the detection sensitivity due to the autofluorescence from living animals. In order to overcome this critical issue, the present article introduces a novel multifunctional agent based on persistent luminescence mesoporous nanoparticles. Being composed of a hybrid chromium-doped zinc gallate core/mesoporous silica shell architecture, we show that this nanotechnology can be used as an efficient doxorubicin-delivery vehicle presenting a higher cytotoxicity toward U87MG cells than its unloaded counterpart in vitro. In addition, we demonstrate that a persistent luminescence signal from these doxorubicin-loaded mesoporous nanophosphors opens a new way to highly sensitive detection in vivo, giving access to the real-time biodistribution of the carrier without any autofluorescence from the animal tissues. This new persistent luminescence-based hybrid nanotechnology can be easily applied to the delivery of any therapeutic agent, thus constituting a versatile and sensitive optical nanotool dedicated to both therapeutic and diagnostic applications in vivo.Based upon the ambitious idea that one single particle could serve multiple purposes at the same time, the combination and simultaneous use of imaging and therapeutics has lately arisen as one of the most promising prospects among nanotechnologies directed toward biomedical

Improved overall delivery documentation following implementation of a standardized shoulder dystocia delivery form

Science.gov (United States)

Moragianni, Vasiliki A.; Hacker, Michele R.; Craparo, Frank J.

2013-01-01

Objective Our objective was to evaluate whether using a standardized shoulder dystocia delivery form improved documentation. A standardized delivery form was added to our institution’s obstetrical record in August 2003. Methods A retrospective cohort study was conducted comparing 100 vaginal deliveries complicated by shoulder dystocia before, and 81 after implementation of the standardized delivery form. The two groups were compared in terms of obstetric characteristics, neonatal outcomes and documentation components. Results Charts that included the standardized delivery form were more likely to contain documentation of estimated fetal weight (82.7% vs. 39.0% without the form, Pdystocia, and second stage duration. Conclusions Inclusion of a standardized form in the delivery record improves the rate of documentation of both shoulder dystocia-specific and general delivery components. PMID:22017330

Technological Advancements and Error Rates in Radiation Therapy Delivery

Energy Technology Data Exchange (ETDEWEB)

Margalit, Danielle N., E-mail: dmargalit@partners.org [Harvard Radiation Oncology Program, Boston, MA (United States); Harvard Cancer Consortium and Brigham and Women' s Hospital/Dana Farber Cancer Institute, Boston, MA (United States); Chen, Yu-Hui; Catalano, Paul J.; Heckman, Kenneth; Vivenzio, Todd; Nissen, Kristopher; Wolfsberger, Luciant D.; Cormack, Robert A.; Mauch, Peter; Ng, Andrea K. [Harvard Cancer Consortium and Brigham and Women' s Hospital/Dana Farber Cancer Institute, Boston, MA (United States)

2011-11-15

Purpose: Technological advances in radiation therapy (RT) delivery have the potential to reduce errors via increased automation and built-in quality assurance (QA) safeguards, yet may also introduce new types of errors. Intensity-modulated RT (IMRT) is an increasingly used technology that is more technically complex than three-dimensional (3D)-conformal RT and conventional RT. We determined the rate of reported errors in RT delivery among IMRT and 3D/conventional RT treatments and characterized the errors associated with the respective techniques to improve existing QA processes. Methods and Materials: All errors in external beam RT delivery were prospectively recorded via a nonpunitive error-reporting system at Brigham and Women's Hospital/Dana Farber Cancer Institute. Errors are defined as any unplanned deviation from the intended RT treatment and are reviewed during monthly departmental quality improvement meetings. We analyzed all reported errors since the routine use of IMRT in our department, from January 2004 to July 2009. Fisher's exact test was used to determine the association between treatment technique (IMRT vs. 3D/conventional) and specific error types. Effect estimates were computed using logistic regression. Results: There were 155 errors in RT delivery among 241,546 fractions (0.06%), and none were clinically significant. IMRT was commonly associated with errors in machine parameters (nine of 19 errors) and data entry and interpretation (six of 19 errors). IMRT was associated with a lower rate of reported errors compared with 3D/conventional RT (0.03% vs. 0.07%, p = 0.001) and specifically fewer accessory errors (odds ratio, 0.11; 95% confidence interval, 0.01-0.78) and setup errors (odds ratio, 0.24; 95% confidence interval, 0.08-0.79). Conclusions: The rate of errors in RT delivery is low. The types of errors differ significantly between IMRT and 3D/conventional RT, suggesting that QA processes must be uniquely adapted for each technique

Technological Advancements and Error Rates in Radiation Therapy Delivery

International Nuclear Information System (INIS)

Margalit, Danielle N.; Chen, Yu-Hui; Catalano, Paul J.; Heckman, Kenneth; Vivenzio, Todd; Nissen, Kristopher; Wolfsberger, Luciant D.; Cormack, Robert A.; Mauch, Peter; Ng, Andrea K.

2011-01-01

Purpose: Technological advances in radiation therapy (RT) delivery have the potential to reduce errors via increased automation and built-in quality assurance (QA) safeguards, yet may also introduce new types of errors. Intensity-modulated RT (IMRT) is an increasingly used technology that is more technically complex than three-dimensional (3D)–conformal RT and conventional RT. We determined the rate of reported errors in RT delivery among IMRT and 3D/conventional RT treatments and characterized the errors associated with the respective techniques to improve existing QA processes. Methods and Materials: All errors in external beam RT delivery were prospectively recorded via a nonpunitive error-reporting system at Brigham and Women’s Hospital/Dana Farber Cancer Institute. Errors are defined as any unplanned deviation from the intended RT treatment and are reviewed during monthly departmental quality improvement meetings. We analyzed all reported errors since the routine use of IMRT in our department, from January 2004 to July 2009. Fisher’s exact test was used to determine the association between treatment technique (IMRT vs. 3D/conventional) and specific error types. Effect estimates were computed using logistic regression. Results: There were 155 errors in RT delivery among 241,546 fractions (0.06%), and none were clinically significant. IMRT was commonly associated with errors in machine parameters (nine of 19 errors) and data entry and interpretation (six of 19 errors). IMRT was associated with a lower rate of reported errors compared with 3D/conventional RT (0.03% vs. 0.07%, p = 0.001) and specifically fewer accessory errors (odds ratio, 0.11; 95% confidence interval, 0.01–0.78) and setup errors (odds ratio, 0.24; 95% confidence interval, 0.08–0.79). Conclusions: The rate of errors in RT delivery is low. The types of errors differ significantly between IMRT and 3D/conventional RT, suggesting that QA processes must be uniquely adapted for each technique

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.

Science.gov (United States)

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

Technical Improvement and Application of Hydrodynamic Gene Delivery in Study of Liver Diseases

Directory of Open Access Journals (Sweden)

Mei Huang

2017-08-01

Full Text Available Development of an safe and efficient in vivo gene delivery method is indispensable for molecular biology research and the progress in the following gene therapy. Over the past few years, hydrodynamic gene delivery (HGD with naked DNA has drawn increasing interest in both research and potential clinic applications due to its high efficiency and low risk in triggering immune responses and carcinogenesis in comparison to viral vectors. This method, involving intravenous injection (i.v. of massive DNA in a short duration, gives a transient but high in vivo gene expression especially in the liver of small animals. In addition to DNA, it has also been shown to deliver other substance such as RNA, proteins, synthetic small compounds and even viruses in vivo. Given its ability to robustly mimic in vivo hepatitis B virus (HBV production in liver, HGD has become a fundamental and important technology on HBV studies in our group and many other groups. Recently, there have been interesting reports about the applications and further improvement of this technology in other liver research. Here, we review the principle, safety, current application and development of hydrodynamic delivery in liver disease studies, and discuss its future prospects, clinical potential and challenges.

Multicentre epidemiological survey on the incidence of Streptococcus agalactiae in pregnancy

Directory of Open Access Journals (Sweden)

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.

Is Institutional Delivery Protective Against Neonatal Mortality Among Poor or Tribal Women? A Cohort Study From Gujarat, India.

Science.gov (United States)

Altman, Rebecca; Sidney, Kristi; De Costa, Ayesha; Vora, Kranti; Salazar, Mariano

2017-05-01

Objectives In low-income settings, neonatal mortality rates (NMR) are higher among socioeconomically disadvantaged groups. Institutional deliveries have been shown to be protective against neonatal mortality. In Gujarat, India, the access of disadvantaged women to institutional deliveries has increased. However, the impact of increased institutional delivery on NMR has not been studied here. This paper examined if institutional childbirth is associated with lower NMR among disadvantaged women in Gujarat, India. Methods A community-based prospective cohort of pregnant women was followed in three districts in Gujarat, India (July 2013-November 2014). Two thousand nine hundred and nineteen live births to disadvantaged women (tribal or below poverty line) were included in the study. Data was analyzed using multivariable logistic regression. Results The overall NMR was 25 deaths per 1000 live births. Multivariable analysis showed that institutional childbirth was protective against neonatal mortality only among disadvantaged women with obstetric complications during delivery. Among mothers with obstetric complications during delivery, those who gave birth in a private or public facility had significantly lower odds of having a neonatal death than women delivering at home (AOR 0.07 95% CI 0.01-0.45 and AOR 0.03, 95% CI 0.00-0.33 respectively). Conclusions for Practice Our findings highlight the crucial role of institutional delivery to prevent neonatal deaths among those born to disadvantaged women with complications during delivery in this setting. Efforts to improve disadvantaged women's access to good quality obstetric care must continue in order to further reduce the NMR in Gujarat, India.

REVIVE Trial: Retrograde Delivery of Autologous Bone Marrow in Patients With Heart Failure.

Science.gov (United States)

Patel, Amit N; Mittal, Sanjay; Turan, Goekmen; Winters, Amalia A; Henry, Timothy D; Ince, Hueseyin; Trehan, Naresh

2015-09-01

Cell therapy is an evolving option for patients with end-stage heart failure and ongoing symptoms despite optimal medical therapy. Our goal was to evaluate retrograde bone marrow cell delivery in patients with either ischemic heart failure (IHF) or nonischemic heart failure (NIHF). This was a prospective randomized, multicenter, open-label study of the safety and feasibility of bone marrow aspirate concentrate (BMAC) infused retrograde into the coronary sinus. Sixty patients were stratified by IHF and NIHF and randomized to receive either BMAC infusion or control (standard heart failure care) in a 4:1 ratio. Accordingly, 24 subjects were randomized to the ischemic BMAC group and 6 to the ischemic control group. Similarly, 24 subjects were randomized to the nonischemic BMAC group and 6 to the nonischemic control group. All 60 patients were successfully enrolled in the study. The treatment groups received BMAC infusion without complications. The left ventricular ejection fraction in the patients receiving BMAC demonstrated significant improvement compared with baseline, from 25.1% at screening to 31.1% at 12 months (p=.007) in the NIHF group and from 26.3% to 31.1% in the IHF group (p=.035). The end-systolic diameter decreased significantly in the nonischemic BMAC group from 55.6 to 50.9 mm (p=.020). Retrograde BMAC delivery is safe. All patients receiving BMAC experienced improvements in left ventricular ejection fraction, but only those with NIHF showed improvements in left ventricular end-systolic diameter and B-type natriuretic peptide. These results provide the basis for a larger clinical trial in HF patients. This work is the first prospective randomized clinical trial using high-dose cell therapy delivered via a retrograde coronary sinus infusion in patients with heart failure. This was a multinational, multicenter study, and it is novel, translatable, and scalable. On the basis of this trial and the safety of retrograde coronary sinus infusion, there are

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

Multifunctional Nanoparticles for Drug Delivery Applications Imaging, Targeting, and Delivery

CERN Document Server

Prud'homme, Robert

2012-01-01

This book clearly demonstrates the progression of nanoparticle therapeutics from basic research to applications. Unlike other books covering nanoparticles used in medical applications, Multifunctional Nanoparticles for Drug Delivery Applications presents the medical challenges that can be reduced or even overcome by recent advances in nanoscale drug delivery. Each chapter highlights recent progress in the design and engineering of select multifunctional nanoparticles with topics covering targeting, imaging, delivery, diagnostics, and therapy.

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)

Energy Technology Data Exchange (ETDEWEB)

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.)

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 ...

Designing synthetic RNA for delivery by nanoparticles

International Nuclear Information System (INIS)

Jedrzejczyk, Dominika; Pawlowska, Roza; Chworos, Arkadiusz; Gendaszewska-Darmach, Edyta

2017-01-01

The rapid development of synthetic biology and nanobiotechnology has led to the construction of various synthetic RNA nanoparticles of different functionalities and potential applications. As they occur naturally, nucleic acids are an attractive construction material for biocompatible nanoscaffold and nanomachine design. In this review, we provide an overview of the types of RNA and nucleic acid’s nanoparticle design, with the focus on relevant nanostructures utilized for gene-expression regulation in cellular models. Structural analysis and modeling is addressed along with the tools available for RNA structural prediction. The functionalization of RNA-based nanoparticles leading to prospective applications of such constructs in potential therapies is shown. The route from the nanoparticle design and modeling through synthesis and functionalization to cellular application is also described. For a better understanding of the fate of targeted RNA after delivery, an overview of RNA processing inside the cell is also provided. (topical review)

Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case–control study in the UK

Science.gov (United States)

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

Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial-the EOLE study protocol.

Science.gov (United States)

Barasinski, Chloé; Vendittelli, Françoise

2016-12-20

The scientific data currently available do not allow any definitive conclusion to be reached about what type of pushing should be recommended to women during the second stage of labour. The objective of this trial is to assess and compare the effectiveness of directed open-glottis pushing versus directed closed-glottis pushing. Secondary objectives are to assess, according to the type of pushing: immediate maternal and neonatal morbidity, intermediate-term maternal pelvic floor morbidity, uncomplicated birth, and women's satisfaction at 4 weeks post partum. This multicentre randomised clinical trial compares directed closed-glottis pushing (Valsalva) versus directed open-glottis pushing during the second stage of labour in 4 hospitals of France. The study population includes pregnant women who received instruction in both types of pushing, have no previous caesarean delivery, are at term and have a vaginal delivery planned. Randomisation takes place during labour once cervical dilation ≥7 cm. The principal end point is assessed by a composite criterion: spontaneous delivery without perineal lesion (no episiotomy or spontaneous second-degree, third-degree or fourth-degree lacerations). We will need to recruit 125 women per group. The primary analysis will be by intention-to-treat analysis, with the principal results reported as crude relative risks (RRs) with their 95% CIs. A multivariate analysis will be performed to take prognostic and confounding factors into account to obtain adjusted RRs. This study was approved by a French Institutional Review Board (Comité de Protection des Personnes Sud Est 6:N°AU1168). Results will be reported in peer-reviewed journals and at scientific meetings. This study will make it possible to assess the effectiveness of 2 types of directed pushing used in French practice and to assess their potential maternal, fetal and neonatal effects. Findings from the study will be useful for counselling pregnant women before and during

Effect of the type of maternal pushing during the second stage of labour on obstetric and neonatal outcome: a multicentre randomised trial—the EOLE study protocol

Science.gov (United States)

Barasinski, Chloé; Vendittelli, Françoise

2016-01-01

Introduction The scientific data currently available do not allow any definitive conclusion to be reached about what type of pushing should be recommended to women during the second stage of labour. The objective of this trial is to assess and compare the effectiveness of directed open-glottis pushing versus directed closed-glottis pushing. Secondary objectives are to assess, according to the type of pushing: immediate maternal and neonatal morbidity, intermediate-term maternal pelvic floor morbidity, uncomplicated birth, and women's satisfaction at 4 weeks post partum. Methods and analysis This multicentre randomised clinical trial compares directed closed-glottis pushing (Valsalva) versus directed open-glottis pushing during the second stage of labour in 4 hospitals of France. The study population includes pregnant women who received instruction in both types of pushing, have no previous caesarean delivery, are at term and have a vaginal delivery planned. Randomisation takes place during labour once cervical dilation ≥7 cm. The principal end point is assessed by a composite criterion: spontaneous delivery without perineal lesion (no episiotomy or spontaneous second-degree, third-degree or fourth-degree lacerations). We will need to recruit 125 women per group. The primary analysis will be by intention-to-treat analysis, with the principal results reported as crude relative risks (RRs) with their 95% CIs. A multivariate analysis will be performed to take prognostic and confounding factors into account to obtain adjusted RRs. Ethics and dissemination This study was approved by a French Institutional Review Board (Comité de Protection des Personnes Sud Est 6:N°AU1168). Results will be reported in peer-reviewed journals and at scientific meetings. This study will make it possible to assess the effectiveness of 2 types of directed pushing used in French practice and to assess their potential maternal, fetal and neonatal effects. Findings from the study will be

Coffee, tea and melanoma risk: findings from the European Prospective Investigation into Cancer and Nutrition.

Science.gov (United States)

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.

Colloidal drug delivery system: amplify the ocular delivery.

Science.gov (United States)

Ali, Javed; Fazil, Mohd; Qumbar, Mohd; Khan, Nazia; Ali, Asgar

2016-01-01

The ocular perceivers are the most voluntarily accessible organs in terms of location in the body, yet drug distribution to these tissues is one of the most intriguing and challenging endeavors and problematic to the pharmaceutical scientist. The most of ocular diseases are treated with topical application of conventional formulation, i.e. solutions, suspensions and ointment. Typically on installation of these conventional formulations, only <5% of the applied dose penetrates the cornea and reaches intraocular tissues, while a major fraction of the instilled dose is wastage due to the presence of many ocular barriers like external barriers, rapid loss of the instilled solution from the precorneal area and nasolacrimal drainage system. Systemic absorption caused systemic side effects varying from mild to life-threatening events. The main objective of this review is to explore the role of colloidal delivery of drug to minimize the drawbacks associated with them. This review provides an insight into the various constraints associated with ocular drug delivery, summarizes recent findings and applications of colloidal delivery systems, i.e. nanoparticles, nanosuspensions, liposomes, niosomes, dendrimers and contact lenses containing nanoparticles have the capacity to distribute ocular drugs to categorical target sites and hold promise to revolutionize the therapy of many ocular perceiver diseases and minimized the circumscription of conventional delivery. Form the basis of literature review, it has been found that the novel delivery system have greater impact to maximize ocular drug absorption, and minimize systemic absorption and side effects.

Neonatal outcomes and operative vaginal delivery versus cesarean delivery.

LENUS (Irish Health Repository)

Contag, Stephen A

2010-06-01

We compared outcomes for neonates with forceps-assisted, vacuum-assisted, or cesarean delivery in the second stage of labor. This is a secondary analysis of a randomized trial in laboring, low-risk, nulliparous women at >or=36 weeks\\' gestation. Neonatal outcomes after use of forceps, vacuum, and cesarean were compared among women in the second stage of labor at station +1 or below (thirds scale) for failure of descent or nonreassuring fetal status. Nine hundred ninety women were included in this analysis: 549 (55%) with an indication for delivery of failure of descent and 441 (45%) for a nonreassuring fetal status. Umbilical cord gases were available for 87% of neonates. We found no differences in the base excess (P = 0.35 and 0.78 for failure of descent and nonreassuring fetal status) or frequencies of pH below 7.0 (P = 0.73 and 0.34 for failure of descent and nonreassuring fetal status) among the three delivery methods. Birth outcomes and umbilical cord blood gas values were similar for those neonates with a forceps-assisted, vacuum-assisted, or cesarean delivery in the second stage of labor. The occurrence of significant fetal acidemia was not different among the three delivery methods regardless of the indication.

Prophylactic amnioinfusion in preganancies complicated by chorioamnionitis: a prospective randomized trial.

Science.gov (United States)

Parilla, B V; McDermott, T M

1998-01-01

The objective of this article is to prospectively investigate the efficacy of amnioinfusion as a means to reduce febrile morbidity in pregnancies complicated by chorioamnionitis. All laboring patients with a temperature > or =100.1 degrees F were approached for study participation. Exclusion criteria included amnionitis diagnosed at greater than 8 cm dilation, multiple gestation, placental abruption, or a nonreassuring fetal heart rate tracing. Consenting patients were randomized to receive antibiotics (ampicillin or penicillin with gentamicin) and acetaminophen with or without amnioinfusion. All patients received intrauterine pressure catheter placement. For study patients, normal saline at room temperature was infused at 10 mL/min for 60 min, then 3 mL/min until delivery. Postpartum endometritis was defined as a temperature = 100.4 degrees F accompanied by uterine tenderness more than 12 hr after delivery. Statistical analysis was performed using the Student's t-test for continuous data and Chi-square for discrete variables. Thirty-six patients were enrolled, and complete data were available for 34 patients (17 in each group). There were no differences between groups with respect to maternal age, gravidity, race, or gestational age. There were also no differences between groups in duration of rupture of membranes, temperature at randomization, interval from randomization to delivery, cesarean section rate, or umbilical cord arterial pH. The mean temperature at the time of delivery was 99.8+/-0.9 degrees F for the amnioinfusion group versus 100.5+/-1.0 degrees F for the control group (p=0.046). Three of 17 amnioinfusion patients and 3 of 17 control patients had postpartum endometritis. There was 1 neonatal infection in the treatment group and no neonatal infections among the control patients. Prophylactic amnioinfusion was associated with a decline in temperature at the time of delivery. No untoward effects from the amnioinfusion were identified.

Assisted delivery with forceps

Science.gov (United States)

... page: //medlineplus.gov/ency/patientinstructions/000509.htm Assisted delivery with forceps To use the sharing features on ... called vacuum assisted delivery . When is a Forceps Delivery Needed? Even after your cervix is fully dilated ( ...

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:

Light-responsive micelles of spiropyran initiated hyperbranched polyglycerol for smart drug delivery.

Science.gov (United States)

Son, Suhyun; Shin, Eeseul; Kim, Byeong-Su

2014-02-10

Light-responsive polymeric micelles have emerged as site-specific and time-controlled systems for advanced drug delivery. Spiropyran (SP), a well-known photochromic molecule, was used to initiate the ring-opening multibranching polymerization of glycidol to afford a series of hyperbranched polyglycerols (SP-hb-PG). The micelle assembly and disassembly were induced by an external light source owing to the reversible photoisomerization of hydrophobic SP to hydrophilic merocyanine (MC). Transmission electron microscopy, atomic force microscopy, UV/vis spectroscopy, and dynamic light scattering demonstrated the successful assembly and disassembly of SP-hb-PG micelles. In addition, the critical micelle concentration (CMC) was determined through the fluorescence analysis of pyrene to confirm the amphiphilicity of respective SP-hb-PGn (n = 15, 29, and 36) micelles, with CMC values ranging from 13 to 20 mg/L, which is correlated to the length of the polar polyglycerol backbone. Moreover, the superior biocompatibility of the prepared SP-hb-PG was evaluated using WI-38 cells and HeLa cells, suggesting the prospective applicability of the micelles in smart drug delivery systems.

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

TRANSDERMAL DRUG DELIVERY SYSTEM: REVIEW

OpenAIRE

Vishvakarama Prabhakar; Agarwal Shivendra; Sharma Ritika; Saurabh Sharma

2012-01-01

Various new technologies have been developed for the transdermal delivery of some important drugs. Today about 74% of drugs are taken orally and are found not to be as effective as desired. To improve such characters transdermal drug delivery system was emerged. Drug delivery through the skin to achieve a systemic effect of a drug is commonly known as transdermal drug delivery and differs from traditional topical drug delivery. Transdermal drug delivery systems (TDDS) are dosage forms involve...

Ethical issues in cesarean delivery.

Science.gov (United States)

Chervenak, Frank A; McCullough, Laurence B

2017-08-01

Cesarean delivery is the most common and important surgical intervention in obstetric practice. Ethics provides essential guidance to obstetricians for offering, recommending, recommending against, and performing cesarean delivery. This chapter provides an ethical framework based on the professional responsibility model of obstetric ethics. This framework is then used to address two especially ethically challenging clinical topics in cesarean delivery: patient-choice cesarean delivery and trial of labor after cesarean delivery. This chapter emphasizes a preventive ethics approach, designed to prevent ethical conflict in clinical practice. To achieve this goal, a preventive ethics approach uses the informed consent process to offer cesarean delivery as a medically reasonable alternative to vaginal delivery, to recommend cesarean delivery, and to recommend against cesarean delivery. The limited role of shared decision making is also described. The professional responsibility model of obstetric ethics guides this multi-faceted preventive ethics approach. Copyright © 2017. Published by Elsevier Ltd.

Psychological stress during pregnancy and stillbirth: prospective study

DEFF Research Database (Denmark)

Wisborg, K.; Barklin, A.; Hedegaard, M.

2008-01-01

habits, alcohol and caffeine intake during pregnancy, education and cohabitation failed to change the result. The results remained essentially unchanged after exclusion of preterm deliveries. Exclusion of women with complications during pregnancy such as diabetes, hypertension, vaginal bleeding......OBJECTIVE: To study the association between psychological stress during pregnancy and stillbirth. DESIGN: Prospective follow-up study. SETTING: Aarhus University Hospital, Skejby, Denmark,1989-98. POPULATION: A total of 19 282 singleton pregnancies in women with valid information about...... psychological stress during pregnancy. METHODS: Information about psychological stress during pregnancy was obtained from questionnaires and measured by the 12-item General Health Questionnaires (GHQ). A score was generated by the sum of all the answers, each contributing a value between 0 (low psychological...

External cephalic version for breech presentation at term. A prospective interventional study.

Science.gov (United States)

Al-Jwadi, Saja A; Al-Ibrahim, Baraa L Humo

2014-08-01

To evaluate the external cephalic version (ECV) procedure for the management of at term breech presenting fetuses. In this prospective, interventional study, 90 patients with uncomplicated breech presentations at or after 37 weeks' gestation were considered for ECV. This was performed in Al-Batool Teaching Hospital, Mosul, Iraq, between January 2011 and March 2012. The main outcome measure was assessed as the success rate of ECV attempt and the rate of cesarean section following a successful procedure. Parity, type of breech, placental location, and birth weight were evaluated as predictors of success. Also, any fetal or maternal complications during the procedure were evaluated. Data were analyzed by x2 test. Statistical significance was determined at a level of pbreech. There were no serious fetal or maternal complications associated with the attempt. With appropriate selection of patients, ECV is highly successful and is a safer alternative to vaginal breech delivery or cesarean delivery.

The U.S. Twin Delivery Volume and Association with Cesarean Delivery Rates: A Hospital-Level Analysis.

Science.gov (United States)

Easter, Sarah Rae; Robinson, Julian N; Carusi, Daniela; Little, Sarah E

2018-03-01

 The objective of this study was to test whether hospitals experienced in twin delivery have lower rates of cesarean delivery for twins.  We divided obstetric hospitals in the 2011 National Inpatient Sample by quartile of annual twin deliveries and compared twin cesarean delivery rates between hospitals with weighted linear regression. We used Pearson's coefficients to correlate a hospital's twin cesarean delivery rate to its overall cesarean delivery and vaginal birth after cesarean (VBAC) rates.  Annual twin delivery volume ranged from 1 to 506 across the 547 analyzed hospitals with a median of 10 and mode of 3. Adjusted rates of cesarean delivery were independent of delivery volume with a rate of 75.5 versus 74.8% in the lowest and highest volume hospitals ( p  = 0.09 across quartiles). A hospital's cesarean delivery rate for twins moderately correlated with the overall cesarean rate ( r  = 0.52, p  < 0.01) and inversely correlated with VBAC rate ( r  =  - 0.42, p  < 0.01).  Most U.S. obstetrical units perform a low volume of twin deliveries with no decrease in cesarean delivery rates at higher volume hospitals. Twin cesarean delivery rates correlate with other obstetric parameters such as singleton cesarean delivery and VBAC rates suggesting twin cesarean delivery rate is more closely related to a hospital's general obstetric practice than its twin delivery volume. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

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.

Ultrasound cervical length in predicting preterm birth: Prospective study

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Achour Radhouane

2017-08-01

Full Text Available Background Preterm birth is a leading cause of perinatal morbidity and mortality and represents a major public health problem. It is associated with a 15–20 per cent mortality rate and remains responsible for 75 per cent of perinatal deaths in foetuses without anomalies. Aims The aim of this study was to evaluate the importance of cervical length measured in the first trimester (11–14 Weeks of amenorrhea “WA” and the second trimester (20–24 Weeks of amenorrhea” WA” in an asymptomatic population of singleton pregnancies to assess the risk of spontaneous preterm birth compared to the digital assessment. Methods We conducted a prospective, longitudinal study involving 117 asymptomatic women with singleton pregnancies between January and December 2015. Results In our study, the clinical examination had a low positive predictive value and a low sensibility for screening women at risk of preterm delivery. Cervical length less than 35mm between 12–14WA and 30mm between 22–24WA predicts the occurrence of preterm birth with a high sensitivity (Se, and specificity (Sp. Conclusion We conclude that ultrasound screening of preterm delivery is now highly recommended.

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

Normal Range of Head-to-body Delivery Interval by Two-step Delivery

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Hong-Yu Zhang

2016-01-01

Conclusions: The average time of head-to-body delivery interval was longer than 60 s by two-step delivery. Majority shoulders were delivered at the first contraction. Majority shoulders emerged from perineum rather from under pubic arch. The routine one-step method of shoulder delivery where the downward force applied is not necessary and is not the right direction. Baby's breath, making faces, sucking, bubble from noses and mouth, and the light blue color of the faces, all those signs during shoulder delivery indicated a normal live birth.

Selective intrapartum anti-bioprophylaxy of group B streptococci infection of neonates: a prospective study in 2454 subsequent deliveries.

Science.gov (United States)

Poulain, P; Betremieux, P; Donnio, P Y; Proudhon, J F; Karege, G; Giraud, J R

1997-04-01

To investigate the efficacy of a selective intrapartum prophylaxy of group B streptococci (GBS) infection of the neonates. A prospective protocol of universal antepartum screening of GBS and selective intrapartum treatment from the 1st February 1994 to the 31st December 1995, on 2454 subsequent deliveries was designed. Our policy included: (1) antepartum screening as soon as possible after 28 weeks by a single vaginal and perianal sample for culture; (2) intrapartum recognition of one condition of high risk of fetal contamination during labor (these conditions included: a temperature of 38 degrees C during labor, rupture of membranes for more than 12 h or prolonged labor for more than 12 h with rupture of membranes, prematurity, twins, maternal diabetes, previous pregnancy with GBS infection of the neonate); and (3) intrapartum anti-bioprophylaxy (amoxicillin) for women with positive screening during pregnancy and one condition of high risk of fetal contamination during labor. We studied the outcome of neonates during this period to look for immediate GBS severe infection of the neonates in the form of bacteraemia or meningitis and compared the results with the rate of neonatal infection before this protocol (4.5/1000 live births in 1993). We noted that 11% of pregnant women were carriers, 25% of which led to antibiotic chemoprophylaxis during the labor. We noticed four cases of neonatal bacteraemia of GBS. One case arose from the group of carriers (but no condition of risk of fetal contamination during the labor and no chemoprophylaxy). The three other cases were from women with a negative antepartum screening. There was no case of meningitis and all four babies were in good health at day 10 of life. Comparing with results prior to the study, we noticed that the rate of neonatal bacteraemia dropped from 4.5 to 1.6 per 1000 livebirths (P < 0.0001). This protocol of intrapartum anti-bioprophylaxy significantly decreases the rate of GBS neonatal sepsis. We propose to

Levodopa delivery systems: advancements in delivery of the gold standard.

Science.gov (United States)

Ngwuluka, Ndidi; Pillay, Viness; Du Toit, Lisa C; Ndesendo, Valence; Choonara, Yahya; Modi, Girish; Naidoo, Dinesh

2010-02-01

Despite the fact that Parkinson's disease (PD) was discovered almost 200 years ago, its treatment and management remain immense challenges because progressive loss of dopaminergic nigral neurons, motor complications experienced by the patients as the disease progresses and drawbacks of pharmacotherapeutic management still persist. Various therapeutic agents have been used in the management of PD, including levodopa (l-DOPA), selegiline, amantadine, bromocriptine, entacapone, pramipexole dihydrochloride and more recently istradefylline and rasagiline. Of all agents, l-DOPA although the oldest, remains the most effective. l-DOPA is easier to administer, better tolerated, less expensive and is required by almost all PD patients. However, l-DOPA's efficacy in advanced PD is significantly reduced due to metabolism, subsequent low bioavailability and irregular fluctuations in its plasma levels. Significant strides have been made to improve the delivery of l-DOPA in order to enhance its bioavailability and reduce plasma fluctuations as well as motor complications experienced by patients purportedly resulting from pulsatile stimulation of the striatal dopamine receptors. Drug delivery systems that have been instituted for the delivery of l-DOPA include immediate release formulations, liquid formulations, dispersible tablets, controlled release formulations, dual-release formulations, microspheres, infusion and transdermal delivery, among others. In this review, the l-DOPA-loaded drug delivery systems developed over the past three decades are elaborated. The ultimate aim was to assess critically the attempts made thus far directed at improving l-DOPA absorption, bioavailability and maintenance of constant plasma concentrations, including the drug delivery technologies implicated. This review highlights the fact that neuropharmaceutics is at a precipice, which is expected to spur investigators to take that leap to enable the generation of innovative delivery systems for the

Patients with alcohol use disorder: initial results from a prospective multicenter registry in the Spanish Network on Addiction Disorders. CohRTA Study.

Science.gov (United States)

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.

Reduction of treatment delivery variances with a computer-controlled treatment delivery system

International Nuclear Information System (INIS)

Fraass, B.A.; Lash, K.L.; Matrone, G.M.; Lichter, A.S.

1997-01-01

Purpose: To analyze treatment delivery variances for 3-D conformal therapy performed at various levels of treatment delivery automation, ranging from manual field setup to virtually complete computer-controlled treatment delivery using a computer-controlled conformal radiotherapy system. Materials and Methods: All external beam treatments performed in our department during six months of 1996 were analyzed to study treatment delivery variances versus treatment complexity. Treatments for 505 patients (40,641 individual treatment ports) on four treatment machines were studied. All treatment variances noted by treatment therapists or quality assurance reviews (39 in all) were analyzed. Machines 'M1' (CLinac (6(100))) and 'M2' (CLinac 1800) were operated in a standard manual setup mode, with no record and verify system (R/V). Machines 'M3' (CLinac 2100CD/MLC) and ''M4'' (MM50 racetrack microtron system with MLC) treated patients under the control of a computer-controlled conformal radiotherapy system (CCRS) which 1) downloads the treatment delivery plan from the planning system, 2) performs some (or all) of the machine set-up and treatment delivery for each field, 3) monitors treatment delivery, 4) records all treatment parameters, and 5) notes exceptions to the electronically-prescribed plan. Complete external computer control is not available on M3, so it uses as many CCRS features as possible, while M4 operates completely under CCRS control and performs semi-automated and automated multi-segment intensity modulated treatments. Analysis of treatment complexity was based on numbers of fields, individual segments (ports), non-axial and non-coplanar plans, multi-segment intensity modulation, and pseudo-isocentric treatments (and other plans with computer-controlled table motions). Treatment delivery time was obtained from the computerized scheduling system (for manual treatments) or from CCRS system logs. Treatment therapists rotate among the machines, so this analysis

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.

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

Early multicentre experience of pre-pectoral implant based immediate breast reconstruction using Braxon®.

Science.gov (United States)

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

Trial of labor compared to repeat cesarean section in women with no other risk factors than a prior cesarean delivery

DEFF Research Database (Denmark)

Studsgaard, Anne; Skorstengaard, Malene; Glavind, Julie

2013-01-01

OBJECTIVE: To compare outcomes with trial of labor after cesarean (TOLAC) or elective repeat cesarean delivery on maternal request (ERCD-MR). DESIGN: Prospective cohort study. SETTING: Danish university hospital. POPULATION: Women with TOLAC (n = 1161) and women with ERCD-MR (n = 622) between 2003...... registration of the deliveries. MAIN OUTCOME MEASURES: Adverse neonatal outcomes, risk factors for emergency cesarean, and uterine rupture in case of TOLAC. RESULTS: TOLAC was associated with an increased risk of neonatal depression [odds ratio (OR) 3.6, 95% confidence interval (CI) 1.1-19.1] and neonatal...... vaginal delivery (adjusted OR 1.8, 95% CI 1.1-3.0), index emergency cesarean during labor (adjusted OR 3.0, 95% CI 2.3-4.1), maternal age ≥35 years (adjusted OR 1.9, 95% CI 1.3-2.8), pre-pregnancy body mass index ≥30 (adjusted OR 2.1, 95% CI 1.3-3.3), and birthweight 4000-4499 g (adjusted OR 1.5, 95% CI 1...

Risk factors for cesarean delivery and adverse neonatal outcome in twin pregnancies attempting vaginal delivery.

Science.gov (United States)

Schachter-Safrai, Natali; Karavani, Gilad; Haj-Yahya, Rani; Ofek Shlomai, Noa; Porat, Shay

2018-02-24

Twin vaginal delivery presents a unique clinical challenge for obstetricians. The Twin Birth Study demonstrated the safety of planned vaginal delivery regarding neonatal outcomes. However, that study lacked a description of the risk factors associated with and the outcome of unplanned cesarean section. The aim of this study is to identify potential risk factors for cesarean section and delivery related neonatal morbidity and mortality in women with twin pregnancy attempting vaginal delivery. A retrospective cohort study including 1070 women with twin pregnancy that underwent a trial of labor between 2003 and 2015. The study population was divided according to the mode of delivery: vaginal delivery, combined vaginal-cesarean and intrapartum cesarean delivery of both twins. Several risk factors and neonatal outcomes were examined by both univariate analysis and multinomial logistic regression analysis. The rate of vaginal delivery of both twins was 88.3%, whereas the rates of combined vaginal cesarean and unplanned cesarean delivery were 4.6% and 7.1%, respectively. Nulliparity and nonvertex presentation of twin B were found to be independently associated with cesarean delivery for both twins. Additionally, nonvertex presentation of twin B was independently associated with combined vaginal-cesarean delivery. The proportion of neonates with Apgar score cesarean group compared with those delivered by the vaginal route alone. Nulliparity and nonvertex presentation of twin B were found to be associated with intrapartum cesarean delivery in twin pregnancies. © 2018 Nordic Federation of Societies of Obstetrics and Gynecology.

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

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,

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),

Liposome-Based Delivery Systems in Plant Polysaccharides

International Nuclear Information System (INIS)

Meiwan, C.; Yitao, W.; Yanfang, Z.; Xinsheng, P.; Jingjing, H.; Ping, Z.

2012-01-01

Plant polysaccharides consist of many monosaccharide by α or β glycosidic bond which can be extracted by the water, alcohol, lipophile liquid from a variety of plants including Cordyceps sinensis, astragalus, and mushrooms. Recently, many evidences illustrate that natural plant polysaccharides possess various biological activities including strengthening immunity, lowering blood sugar, regulating lipid metabolism, anti oxidation, anti aging, and antitumour. Plant polysaccharides have been widely used in the medical field due to their special features and low toxicity. As an important drug delivery system, liposomes can not only encapsulate small-molecule compound but also big-molecule drug; therefore, they present great promise for the application of plant polysaccharides with unique physical and chemical properties and make remarkable successes. This paper summarized the current progress in plant polysaccharides liposomes, gave an overview on their experiment design method, preparation, and formulation, characterization and quality control, as well as in vivo and in vitro studies. Moreover, the potential application of plant polysaccharides liposomes was prospected as well.

Sensitivity of imaging for multifocal-multicentric breast carcinoma

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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...

Intrapartum amnioinfusion for meconium-stained fluid: meta-analysis of prospective clinical trials.

Science.gov (United States)

Pierce, J; Gaudier, F L; Sanchez-Ramos, L

2000-06-01

To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid. We identified prospective clinical trials of amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid (AF) published in English by using computerized databases, references in published studies, and index reviews. We analyzed prospective studies of intrapartum amnioinfusion for meconium-stained AF. In every case, group allocation was based exclusively on meconium in AF. Only published studies with clearly documented outcome data were included. The trials were evaluated for meconium below the vocal cords, meconium aspiration syndrome, fetal acidemia, cesarean delivery, and postpartum endometritis. Each trial was evaluated for the quality of its methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. Thirteen studies met inclusion criteria for our systematic review. Odds ratios (ORs) with their 95% confidence intervals (CIs) were calculated for each outcome. Estimates of ORs and risk differences for dichotomous outcomes were calculated using random and fixed-effects models. We tested for homogeneity across the studies. We found that intrapartum amnioinfusion significantly reduced the frequency of meconium aspiration syndrome (OR 0.30; 95% CI 0.19, 0. 46), of meconium below the vocal cords, and neonatal acidemia. Subjects allocated to receive amnioinfusion also had a significantly lower overall cesarean rate (OR 0.74, 95% CI 0.59, 0.93) without increased postpartum endometritis. Amnioinfusion in cases of meconium-stained fluid significantly improves neonatal outcome, lowers the cesarean delivery rate, and does not increase the postpartum endometritis rate.

Which Iodine concentration in chest CT? - A prospective study in 300 patients

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Muehlenbruch, Georg [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Aachen (Germany); University Hospital, RWTH Aachen University, Aachen (Germany); Behrendt, Florian F.; Eddahabi, Mohammed A.; Das, Marco; Guenther, Rolf W.; Mahnken, Andreas H. [RWTH Aachen University Hospital, Department of Diagnostic and Interventional Radiology, Aachen (Germany); Knackstedt, Christian [RWTH Aachen University Hospital, Department of Cardiology, Pulmonology and Angiology, Aachen (Germany); Stanzel, Sven [RWTH Aachen University Hospital, Institute of Medical Statistics, Aachen (Germany); Seidensticker, Peter [Bayer Schering Pharma AG, Berlin (Germany); Wildberger, Joachim E. [University Hospital Maastricht, Department of Radiology, Maastricht (Netherlands)

2008-12-15

In computed tomography(CT) several contrast media with different iodine concentrations are available. The aim of this study is to prospectively compare contrast media with iodine concentrations of 300, 370 and 400 mg iodine/ml for chest- CT. 300 consecutive patients were prospectively enrolled, under a waiver of the local ethics committee. The first (second, third) 100 patients, received contrast medium with 300(370, 400)mg iodine/ml. Injection protocols were adapted for an identical iodine delivery rate(1.3 mg/s) and total iodine load(33 g) for all three groups. Standardized MDCT of the chest (16 x 0.75 mm, 120 kVp, 100 mAseff.) was performed. Intravascular attenuation values were measured in the pulmonary trunk and the ascending aorta; subjective image quality was rated on a 3-point-scale. Discomfort during and after injection was evaluated. There were no statistically significant differences in contrast enhancement comparing the three contrast media at the pulmonary trunk(p = 0.3198) and at the ascending aorta(p = 0.0840). Image quality(p = 0.0176) and discomfort during injection(p = 0.7034) were comparable for all groups. General discomfort after injection of contrast media with 300 mg iodine/ml was statistically significant higher compared to 370 mg iodine/ml(p = 0.00019). Given identical iodine delivery rates of 1.3 g/s and iodine loads of 33 g, contrast media with concentrations of 300, 370 and 400 mg iodine/ml do not result in different intravascular enhancement in chest-CT. (orig.)

Maternal infection rates after cesarean delivery by Pfannenstiel or Joel-Cohen incision: a multicenter surveillance study.

Science.gov (United States)

Dumas, Anne Marie; Girard, Raphaële; Ayzac, Louis; Caillat-Vallet, Emmanuelle; Tissot-Guerraz, Françoise; Vincent-Bouletreau, Agnès; Berland, Michel

2009-12-01

Our purpose was to evaluate maternal nosocomial infection rates according to the incision technique used for caesarean delivery, in a routine surveillance study. This was a prospective study of 5123 cesarean deliveries (43.2% Joel-Cohen, 56.8% Pfannenstiel incisions) in 35 maternity units (Mater Sud Est network). Data on routine surveillance variables, operative duration, and three additional variables (manual removal of the placenta, uterine exteriorization, and/or cleaning of the parieto-colic gutter) were collected. Multiple logistic regression analysis was used to identify independent risk factors for infection. The overall nosocomial infection and endometritis rates were higher for the Joel-Cohen than Pfannenstiel incision (4.5% vs. 3.3%, 0.8% vs. 0.3%, respectively). The higher rate of nosocomial infections with the Joel-Cohen incision was due to a greater proportion of patients presenting risk factors (i.e., emergency delivery, primary cesarean, blood loss > or =800 mL, no manual removal of the placenta and no uterine exteriorization). However, the Joel-Cohen technique was an independent risk factor for endometritis. The Joel-Cohen technique is faster than the Pfannenstiel technique but is associated with a higher incidence of endometritis.

Multidisciplinary training in perineal care during labor and delivery for the reduction of anal sphincter injuries.

Science.gov (United States)

Frost, Jonathan; Gundry, Rowan; Young, Helen; Naguib, Adel

2016-08-01

To determine whether the introduction of a multidisciplinary intrapartum perineal-care training program reduced the rate of obstetric anal sphincter injuries in patients undergoing vaginal deliveries. A prospective observational cohort study enrolled women undergoing vaginal deliveries at a district general hospital maternity unit in the United Kingdom between April 1, 2012 and March 31, 2014. All women experiencing obstetric anal sphincter injuries during the study period were identified and the rate of obstetric anal sphincter injuries before (2012-2013) a multidisciplinary training program was implemented was compared with the rate after (2013-2014) implementation using logistic regression analysis. The study enrolled 4920 patients. Following the implementation of the training program, the rate of obstetric anal sphincter injuries decreased from 4.8% to 3.1% of vaginal deliveries (odds ratio 0.66; 95% confidence interval 0.493-0.899; P = 0.008). The integration of intrapartum perineal-care training into mandatory annual staff training was associated with a statistically and clinically significant reduction in the rate of obstetric anal sphincter injuries. Copyright © 2016 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.