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Sample records for randomized multicentre study

  1. Video-based feedback of oral clinical presentations reduces the anxiety of ICU medical students: a multicentre, prospective, randomized study

    OpenAIRE

    Schmidt, Matthieu; Freund, Yonathan; Alves, Mickael; Monsel, Antoine; Labbe, Vincent; Darnal, Elsa; Messika, Jonathan; Bokobza, Jerome; Similowski, Thomas; Duguet, Alexandre

    2014-01-01

    International audience; Background: Oral presentations of clinical cases by medical students during medical rounds in hospital wards are a source of anxiety and little is known about how this anxiety can be alleviated. The objective of this study was to investigate whether video-based feedback of public oral presentations can reduce anxiety in 4th year medical students. Methods: Multicentre randomized study conducted in six intensive care units (ICU) and emergency departments (ED) in France o...

  2. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  3. Efficacy and safety of cerivastatin in the treatment of primary hypercholesterolemia: a multicentre, randomized, double-blind study.

    Institute of Scientific and Technical Information of China (English)

    2000-01-01

    Objective: To assess the efficacy and safety of cerivastatin in Chinese with primary hypercholesterolemia. Methods: The multicentre, randomized, double-blind, placebo-controlled, parallel group trial was conducted in 3 hospitals. After a 5-week single-blind run-in period (period A), 470 patients were randomized to receive cerivastatin 0.1mg (n=119), 0.2mg (n=

  4. A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure

    NARCIS (Netherlands)

    Ponikowski, Piotr; Mitrovic, Veselin; Ruda, Mikhail; Fernandez, Alberto; Voors, Adriaan A.; Vishnevsky, Alexander; Cotter, Gad; Milo, Olga; Laessing, Ute; Zhang, Yiming; Dahlke, Marion; Zymlinski, Robert; Metra, Marco

    The aim of this study was to evaluate the haemodynamic effects of serelaxin (30 g/kg/day 20-h infusion and 4-h post-infusion period) in patients with acute heart failure (AHF). This double-blind, multicentre study randomized 71 AHF patients with pulmonary capillary wedge pressure (PCWP) 18 mmHg,

  5. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients : a prospective randomized multicentre study

    NARCIS (Netherlands)

    Scheeren, Thomas W. L.; Wiesenack, Christoph; Gerlach, Herwig; Marx, Gernot

    2013-01-01

    Perioperative hemodynamic optimisation improves postoperative outcome for patients undergoing high-risk surgery (HRS). In this prospective randomized multicentre study we studied the effects of an individualized, goal-directed fluid management based on continuous stroke volume variation (SVV) and st

  6. The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Liang Zhao-Hui

    2012-07-01

    Full Text Available Abstract Background Neck pain is one of the chief symptoms of cervical spondylosis (CS. Acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a randomized controlled trial protocol evaluating the use of acupuncture for CS neck pain, comparing the effects of the optimized acupuncture therapy in real practice compared with sham and shallow acupuncture. Methods/Design This trial uses a multicentre, parallel-group, randomized, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. 945 patients who meet inclusion criteria are randomly assigned to receive optimized acupuncture therapy, sham acupuncture or shallow acupuncture by a computerized central randomization system. The interventions past for 4 weeks with eight to ten treatments in total. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ and The Short Form (36 Health Survey (SF-36 are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA for primary and secondary outcomes of group and time differences. Adverse events (AEs will be reported if they occur. Discussion This trial is a multicentre randomized control trial (RCT on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomization in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the

  7. Azithromycin for Indigenous children with bronchiectasis: study protocol for a multi-centre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Valery Patricia C

    2012-08-01

    Full Text Available Abstract Background The prevalence of chronic suppurative lung disease (CSLD and bronchiectasis unrelated to cystic fibrosis (CF among Indigenous children in Australia, New Zealand and Alaska is very high. Antibiotics are a major component of treatment and are used both on a short or long-term basis. One aim of long-term or maintenance antibiotics is to reduce the frequency of acute pulmonary exacerbations and symptoms. However, there are few studies investigating the efficacy of long-term antibiotic use for CSLD and non-CF bronchiectasis among children. This study tests the hypothesis that azithromycin administered once a week as maintenance antibiotic treatment will reduce the rate of pulmonary exacerbations in Indigenous children with bronchiectasis. Methods/design We are conducting a multicentre, randomised, double-blind, placebo controlled clinical trial in Australia and New Zealand. Inclusion criteria are: Aboriginal, Torres Strait Islander, Maori or Pacific Island children aged 1 to 8 years, diagnosed with bronchiectasis (or probable bronchiectasis with no underlying disease identified (such as CF or primary immunodeficiency, and having had at least one episode of pulmonary exacerbation in the last 12 months. After informed consent, children are randomised to receive either azithromycin (30 mg/kg once a week or placebo (once a week for 12–24 months from study entry. Primary outcomes are the rate of pulmonary exacerbations and time to pulmonary exacerbation determined by review of patient medical records. Secondary outcomes include length and severity of pulmonary exacerbation episodes, changes in growth, school loss, respiratory symptoms, forced expiratory volume in 1-second (FEV1; for children ≥6 years, and sputum characteristics. Safety endpoints include serious adverse events. Antibiotic resistance in respiratory bacterial pathogens colonising the nasopharynx is monitored. Data derived from medical records and clinical

  8. Are minimized perfusion circuits the better heart lung machines? Final results of a prospective randomized multicentre study.

    Science.gov (United States)

    El-Essawi, A; Hajek, T; Skorpil, J; Böning, A; Sabol, F; Ostrovsky, Y; Hausmann, H; Harringer, W

    2011-11-01

    Minimized perfusion circuits (MPCs), although aiming at minimizing the adverse effects of cardiopulmonary bypass, have not yet gained popularity. This can be attributed to concerns regarding their safety, as well as lack of sufficient evidence of their benefit. Described is a randomized, multicentre study comparing the MPC - ROCsafeRX to standard cardiopulmonary bypass in patients undergoing elective coronary artery bypass grafting and/ or aortic valve replacement. Five hundred patients were included in the study (252 randomized to the ROCsafeRX group and 248 to standard cardiopulmonary bypass). Both groups were well matched for demographic characteristics and type of surgery. No operative mortality and no device-related complications were encountered. Transfusion requirement (333 ± 603 vs. 587 ± 1010 ml; p=0.001), incidence of atrial fibrillation (16.3% vs. 24.2%; p=0.03) and the incidence of major adverse events (9.1% vs. 16.5%; p=0.02) were all in favour of the MPC group. These results confirm both the safety and efficacy of the ROCsafeRX MPC for a large variety of cardiac patients. Minimized perfusion circuits should, therefore, play a greater role in daily practice so that as many patients as possible can benefit from their advantages.

  9. Roxatidine versus ranitidine in the treatment of duodenal ulcers: a randomized double-blind controlled multicentre study in Singapore.

    Science.gov (United States)

    Fock, K M; Kang, J Y; Ng, H S; Ng, T M; Gwee, K A; Lim, C C

    1995-01-01

    Roxatidine acetate, a new H2 receptor antagonist, was compared with ranitidine in the treatment of duodenal ulcers in a double-blind multicentre study. Eighty-four patients with endoscopically proven duodenal ulcer were randomized to receive 150 mg roxatidine acetate or 300 mg ranitidine at bedtime. Repeat endoscopy was performed after 4 weeks (25-33 days) and if the ulcer had not healed, another endoscopy was performed after a further 4 weeks of treatment. Using per protocol analysis 73.6% of ulcers treated with roxatidine healed at 4 weeks compared to 72.2% of ulcers treated with ranitidine (P = NS). The healing rates at 8 weeks were 92% with roxatidine and 83.3% with ranitidine (P = NS). Using equivalence tests, the healing rate of roxatidine was found to be equivalent to that of ranitidine within a 20% region. Roxatidine users took significantly less antacids than ranitidine users (P roxatidine or ranitidine. Roxatidine is a safe effective drug in the treatment of duodenal ulcers with a healing rate comparable to that of ranitidine.

  10. Wean Earlier and Automatically with New technology (the WEAN study: a protocol of a multicentre, pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lessard Martin R

    2009-09-01

    Full Text Available Abstract Background Weaning is the process during which mechanical ventilation is withdrawn and the work of breathing is transferred from the ventilator back to the patient. Prolonged weaning is associated with development of ventilator-related complications and longer stays in the Intensive Care Unit (ICU. Computerized or Automated Weaning is a novel weaning strategy that continuously measures and adapts ventilator support (by frequently measuring and averaging three breathing parameters and automatically conducts Spontaneous Breathing Trials to ascertain whether patients can resume autonomous breathing. Automated Weaning holds promise as a strategy to reduce the time spent on the ventilator, decrease ICU length of stay, and improve clinically important outcomes. Methods/Design A pilot weaning randomized controlled trial (RCT is underway in the ICUs of 8 Canadian hospitals. We will randomize 90 critically ill adults requiring invasive ventilation for at least 24 hours and identified at an early stage of the weaning process to either Automated Weaning (SmartCare™ or Protocolized Weaning. The results of a National Weaning Survey informed the design of the Protocolized Weaning arm. Both weaning protocols are operationalized in Pressure Support mode, include opportunities for Spontaneous Breathing Trials, and share a common sedation protocol, oxygen titration parameters, and extubation and reintubation criteria. The primary outcome of the WEAN study is to evaluate compliance with the proposed weaning and sedation protocols. A key secondary outcome of the pilot RCT is to evaluate clinician acceptance of the weaning and sedation protocols. Prior to initiating the WEAN Study, we conducted a run-in phase, involving two patients per centre (randomizing the first participant to either weaning strategy and assigning the second patient to the alternate strategy to ensure that participating centres could implement the weaning and sedation protocols and

  11. Measuring patient-centredness, the neglected outcome in fertility care: a random multicentre validation study.

    NARCIS (Netherlands)

    Empel, I.W.H. van; Aarts, J.W.; Cohlen, B.J.; Huppelschoten, D.; Laven, J.S.E.; Nelen, W.L.D.M.; Kremer, J.A.M.

    2010-01-01

    BACKGROUND: High-quality fertility care should be effective and safe, but also patient-centred. However, a suitable instrument for measuring patient-centredness is lacking. This study aims to develop and validate an instrument that can reliably measure patient-centredness in fertility care: patient-

  12. Measuring patient-centredness, the neglected outcome in fertility care: A random multicentre validation study

    NARCIS (Netherlands)

    I.W.H. van Empel; J.W.M. Aarts (Johanna); B.J. Cohlen (Ben); D.A. Huppelschoten (Dana); J.S.E. Laven (Joop); W.L.D.M. Nelen (Willianne); J.A.M. Kremer

    2010-01-01

    textabstractBACKGROUND: High-quality fertility care should be effective and safe, but also patient-centred. However, a suitable instrument for measuring patient-centredness is lacking. This study aims to develop and validate an instrument that can reliably measure patient-centredness in fertility ca

  13. Bovine lactoferrin for Helicobacter pylori eradication: an open, randomized, multicentre study.

    Science.gov (United States)

    Di Mario, F; Aragona, G; Dal Bó, N; Cavallaro, L; Marcon, V; Olivieri, P; Benedetti, E; Orzès, N; Marin, R; Tafner, G; Chilovi, F; De Bastiani, R; Fedrizzi, F; Franceschi, M; Salvat, M H; Monica, F; Piazzi, L; Valiante, F; Vecchiati, U; Cavestro, G M; Comparato, G; Iori, V; Maino, M; Leandro, G; Pilotto, A; Rugge, M; Franzè, A

    2006-04-15

    Cure rates for eradication of Helicobacter pylori appear to be decreasing, thus more effective therapies must be identified. To evaluate the efficacy of bovine lactoferrin in the treatment of H. pylori infection. In a multicentered prospective study, 402 (mean age 52.4, range 19-84 years) H. pylori-positive patients were assigned to one of three regimens: group A - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for 7 days; group B - lactoferrin 200 mg b.d. for 7 days followed by the same schedule of group A; group C - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. plus lactoferrin 200 mg b.d. for 7 days. Of the 402 patients, 389 completed the study. Six patients were discontinued due to side effects, one patient in group B died and six patients were lost to follow up. The eradication rate (intention-to-treat analysis) was 77% in group A (105/136), 73% in group B (97/132) and 90% in group C (120/134) (chi(2)-test P < 0.01). The incidence of side effects was 9.5% in group A, 9% in group B and 8.2% in group C (chi(2)-test P = 0.1). This study demonstrates that bovine lactoferrin is an effective adjuvant to 7-day triple therapy for eradication of H. pylori infection.

  14. The influence of review pathology on study outcome of a randomized multicentre superficial bladder cancer trial. Members of the Dutch South East Cooperative Urological Group.

    Science.gov (United States)

    Witjes, J A; Kiemeney, L A; Schaafsma, H E; Debruyn, F M

    1994-02-01

    To determine whether differences between local and review pathology in a multicentre study influence the results of treatment and results from prognostic factor analysis. A randomized multicentre study in superficial bladder cancer is reported, in which the influence of local and review pathology on the study outcome was investigated. The conformity between local and review pathology of the pT category was 79.3%, of the grade 70.2%, and the combination of both 59.7%. In local pathology, undergrading was more frequent than overgrading and overstaging more frequent than understaging. However, the risks of recurrent disease in the separate stage and grade groups remained the same after correcting the pathology result. A prognostic factor analysis with regard to the risk of recurrent disease was carried out. The Cox hazard ratios of tumour localization, multiplicity, patient age (significant factors), tumour grade, size, history and gender (not significant) remained almost the same after correction for review pathology. Only the prognostic relevance of tumour stage increased after pathology correction. We conclude that, although review pathology caused considerable changes in the pathology results, this did not change the results of treatment, and hardly altered the results of a prognostic factor analysis in this randomized study.

  15. A randomized, multicentre study of directed daylight exposure times of 11/2 vs. 21/2 h in daylight-mediated photodynamic therapy with methyl aminolaevulinate in patients with multiple thin actinic keratoses of the face and scalp

    DEFF Research Database (Denmark)

    Wiegell, S.R.; Fabricius, S.; Philipsen, P.A.

    2011-01-01

    in a randomized multicentre study. Methods: One hundred and twenty patients with a total of 1572 thin AKs of the face and scalp were randomized to either 11/2- or 21/2-h exposure groups. After gentle lesion preparation and application of a sunscreen of sun protection factor 20, MAL was applied to the entire...

  16. 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), assessor-blind

  17. 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),

  18. Efficacy of a standardized herbal preparation (Roidosanal® in the treatment of hemorrhoids: A randomized, controlled, open-label multicentre study

    Directory of Open Access Journals (Sweden)

    Kapil Aggrawal

    2014-01-01

    Full Text Available Background: Catechins and epicatechins are monomers of naturally occurring proanthocyanidins, which have been reported with free radical scavenging, antioxidant, antiinflammatory, antiallergic, and vasodilatory properties. Plant parts rich in proanthocyanidins have been used for years in treatment of various ano-rectal diseases. This study compares the efficacy of two herbal preparations, Daflon® 500 mg and Roidosanal® , in ameliorating the signs and symptoms associated with hemorrhoids. Objective: To evaluate the safety and to compare the efficacy of a herbal preparation, Roidosanal® versus Daflon® 500 mg, on signs and symptoms of hemorrhoidal disease. Materials and Methods: In this pilot, active controlled, open-labeled multicentre study, 73 patients with proctoscopy proven hemorrhoids (Grade I to III were randomly assigned to receive either Roidosanal® (Gr R; n = 37 or Daflon® 500 mg (Gr D; n = 36, for 15 days, at three centers in India. Assessment of hemorrhoidal symptoms was carried out in all patients at different time points. Intent-to-treat analysis was performed for both primary and secondary endpoints. Results: Baseline characteristics were comparable between the two groups. Both products were found to be equally effective in improving the ano-rectal conditions in Grade I and Grade II hemorrhoids; however, Roidosanal® demonstrated better efficacy in patients with Grade III hemorrhoids. Hemorrhoids associated symptoms like bleeding, pain, etc., improved in both groups, although intergroup comparisons were comparable. Conclusion: Both Roidosanal® and Daflon® 500 mg were equally effective in resolving signs and symptoms of hemorrhoids. Roidosanal® can be tried as a safe and effective treatment option for treatment of hemorrhoids. Further randomized, double-blind and large multicentre studies are recommended.

  19. Efficacy and safety of pioglitazone added to alogliptin in Japanese patients with type 2 diabetes mellitus: a multicentre, randomized, double-blind, parallel-group, comparative study.

    Science.gov (United States)

    Kaku, K; Katou, M; Igeta, M; Ohira, T; Sano, H

    2015-12-01

    A phase IV, multicentre, randomized, double-blind, parallel-group, comparative study was conducted in Japanese subjects with type 2 diabetes mellitus (T2DM) who had inadequate glycaemic control, despite treatment with alogliptin in addition to diet and/or exercise therapy. Subjects with glycated haemoglobin (HbA1c) concentrations of 6.9-10.5% were randomized to receive 16 weeks' double-blind treatment with pioglitazone 15 mg, 30 mg once daily or placebo added to alogliptin 25 mg once daily. The primary endpoint was the change in HbA1c from baseline at the end of treatment period (week 16). Both pioglitazone 15 and 30 mg combination therapy resulted in a significantly greater reduction in HbA1c than alogliptin monotherapy [-0.80 and -0.90% vs 0.00% (the least squares mean using analysis of covariance model); p Pioglitazone/alogliptin combination therapy was effective and generally well tolerated in Japanese subjects with T2DM and is considered to be useful in clinical settings.

  20. Multicentre, randomized, open-label study of on-demand treatment with two prophylaxis regimens of recombinant coagulation factor IX in haemophilia B subjects.

    Science.gov (United States)

    Valentino, L A; Rusen, L; Elezovic, I; Smith, L M; Korth-Bradley, J M; Rendo, P

    2014-05-01

    Few randomized studies have reported on the use of factor IX (FIX) for secondary prophylaxis in haemophilia B patients. This study aimed to evaluate the efficacy and safety of two secondary prophylaxis regimens of recombinant coagulation FIX, nonacog alfa, compared with on-demand therapy. Male subjects aged 6-65 years with severe or moderately severe haemophilia B (FIX:C ≤ 2, n = 50) and ≥12 bleeding episodes (including ≥6 haemarthroses episodes) within 12 months of study participation were enrolled in this multicentre, randomized, open-label, four-period crossover trial. The primary measure was the annualized bleeding rate (ABR) of two prophylactic regimens vs. on-demand therapy. In the intent-to-treat group, mean ABR values were 35.1, 2.6 and 4.6 for the first on-demand period, the 50 IU kg(-1) twice-weekly period, and the 100 IU kg(-1) once-weekly period respectively. Differences in ABR between the first on-demand period and both prophylaxis regimens were significant (P < 0.0001); no significant differences were observed between prophylaxis regimens (P = 0.22). Seven serious adverse events occurred in five subjects, none related to study drug. Results demonstrated that secondary prophylaxis therapy with nonacog alfa 50 IU kg(-1) twice weekly or 100 IU kg(-1) once weekly reduced ABR by 89.4% relative to on-demand treatment. Both prophylaxis regimens demonstrated favourable safety profiles in subjects with haemophilia B.

  1. The Norwegian dietary guidelines and colorectal cancer survival (CRC-NORDIET) study: a food-based multicentre randomized controlled trial.

    Science.gov (United States)

    Henriksen, Hege Berg; Ræder, Hanna; Bøhn, Siv Kjølsrud; Paur, Ingvild; Kværner, Ane Sørlie; Billington, Siv Åshild; Eriksen, Morten Tandberg; Wiedsvang, Gro; Erlund, Iris; Færden, Arne; Veierød, Marit Bragelien; Zucknick, Manuela; Smeland, Sigbjørn; Blomhoff, Rune

    2017-01-30

    Colorectal cancer survivors are not only at risk for recurrent disease but also at increased risk of comorbidities such as other cancers, cardiovascular disease, diabetes, hypertension and functional decline. In this trial, we aim at investigating whether a diet in accordance with the Norwegian food-based dietary guidelines and focusing at dampening inflammation and oxidative stress will improve long-term disease outcomes and survival in colorectal cancer patients. This paper presents the study protocol of the Norwegian Dietary Guidelines and Colorectal Cancer Survival study. Men and women aged 50-80 years diagnosed with primary invasive colorectal cancer (Stage I-III) are invited to this randomized controlled, parallel two-arm trial 2-9 months after curative surgery. The intervention group (n = 250) receives an intensive dietary intervention lasting for 12 months and a subsequent maintenance intervention for 14 years. The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity. Patients are followed-up at 6 months and 1, 3, 5, 7, 10 and 15 years after baseline. The study center is located at the Department of Nutrition, University of Oslo, and patients are recruited from two hospitals within the South-Eastern Norway Regional Health Authority. Primary outcomes are disease-free survival and overall survival. Secondary outcomes are time to recurrence, cardiovascular disease-free survival, compliance to the dietary recommendations and the effects of the intervention on new comorbidities, intermediate biomarkers, nutrition status, physical activity, physical function and quality of life. The current study is designed to gain a better understanding of the role of a healthy diet aimed at dampening inflammation and oxidative stress on long-term disease outcomes and survival in colorectal cancer patients. Since previous research on the role of diet for

  2. Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study).

    Science.gov (United States)

    Roulaud, M; Durand-Zaleski, I; Ingrand, P; Serrie, A; Diallo, B; Peruzzi, P; Hieu, P D; Voirin, J; Raoul, S; Page, P; Fontaine, D; Lantéri-Minet, M; Blond, S; Buisset, N; Cuny, E; Cadenne, M; Caire, F; Ranoux, D; Mertens, P; Naous, H; Simon, E; Emery, E; Gadan, B; Regis, J; Sol, J-C; Béraud, G; Debiais, F; Durand, G; Guetarni Ging, F; Prévost, A; Brandet, C; Monlezun, O; Delmotte, A; d'Houtaud, S; Bataille, B; Rigoard, P

    2015-03-01

    Many studies have demonstrated the efficacy of spinal cord stimulation (SCS) for chronic neuropathic radicular pain over recent decades, but despite global favourable outcomes in failed back surgery syndrome (FBSS) with leg pain, the back pain component remains poorly controlled by neurostimulation. Technological and scientific progress has led to the development of new SCS leads, comprising a multicolumn design and a greater number of contacts. The efficacy of multicolumn SCS lead configurations for the treatment of the back pain component of FBSS has recently been suggested by pilot studies. However, a randomized controlled trial must be conducted to confirm the efficacy of new generation multicolumn SCS. Évaluation médico-économique de la STImulation MEdullaire mulTi-colonnes (ESTIMET) is a multicentre, randomized study designed to compare the clinical efficacy and health economics aspects of mono- vs. multicolumn SCS lead programming in FBSS patients with radicular pain and significant back pain. FBSS patients with a radicular pain VAS score≥50mm, associated with a significant back pain component were recruited in 14 centres in France and implanted with multicolumn SCS. Before the lead implantation procedure, they were 1:1 randomized to monocolumn SCS (group 1) or multicolumn SCS (group 2). Programming was performed using only one column for group 1 and full use of the 3 columns for group 2. Outcome assessment was performed at baseline (pre-implantation), and 1, 3, 6 and 12months post-implantation. The primary outcome measure was a reduction of the severity of low back pain (bVAS reduction≥50%) at the 6-month visit. Additional outcome measures were changes in global pain, leg pain, paraesthesia coverage mapping, functional capacities, quality of life, neuropsychological aspects, patient satisfaction and healthcare resource consumption. Trial recruitment started in May 2012. As of September 2013, all 14 study centres have been initiated and 112

  3. The efficacy and safety of blonanserin compared with haloperidol in acute-phase schizophrenia: a randomized, double-blind, placebo-controlled, multicentre study.

    Science.gov (United States)

    Garcia, Esther; Robert, Marta; Peris, Francesc; Nakamura, Hiroshi; Sato, Noriko; Terazawa, Yoshikatsu

    2009-01-01

    Blonanserin is a novel atypical antipsychotic agent with potent dopamine D(2) and serotonin 5-HT(2) antagonist properties. It may potentially have a lower incidence of adverse events than other antipsychotic agents. To determine the efficacy and safety of three doses of blonanserin compared with placebo and haloperidol in patients with acute-phase schizophrenia. This was a 6-week, randomized, double-blind, placebo- and haloperidol-controlled, international, multicentre study. Patients with an acute exacerbation of their schizophrenia, with a Positive and Negative Syndrome Scale (PANSS) score >/=70 and a Clinical Global Impression - Severity of Illness (CGI-S) score >/=4 ('moderately ill') [with no decrease >/=20% or >/=1 point, respectively, during the wash-out period] were randomized into one of five treatment groups (blonanserin 2.5, 5 or 10 mg, haloperidol 10 mg or placebo once daily). Patients were assessed weekly for clinical efficacy, adverse events, extrapyramidal symptoms (EPS) and drug compliance, and were assessed biweekly for other safety variables. All 307 randomized patients received at least one dose of study medication and 228 (74.3%) completed the study. The mean reduction in PANSS total score at week 6 was significantly greater with all active treatments compared with placebo (-12.58; p blonanserin 10 mg was significantly superior to blonanserin 2.5 mg (-30.18 vs -20.6; p blonanserin 5 mg (-27.19) and haloperidol 10 mg (-28.16) were not. All active treatments showed greater efficacy against the positive symptoms of schizophrenia, and blonanserin (5 and 10 mg) was more effective against the negative symptoms than haloperidol. Blonanserin was well tolerated at all doses and there was no evidence of clinically important weight gain, orthostatic hypotension, corrected QT interval prolongation or clinically relevant changes in laboratory test results. Haloperidol caused persistent elevation in prolactin levels, but this was not seen with any dose of

  4. A randomized, double-blind, placebo-controlled, multicentre study to assess haemodynamic effects of serelaxin in patients with acute heart failure

    Science.gov (United States)

    Ponikowski, Piotr; Mitrovic, Veselin; Ruda, Mikhail; Fernandez, Alberto; Voors, Adriaan A.; Vishnevsky, Alexander; Cotter, Gad; Milo, Olga; Laessing, Ute; Zhang, Yiming; Dahlke, Marion; Zymlinski, Robert; Metra, Marco

    2014-01-01

    Aims The aim of this study was to evaluate the haemodynamic effects of serelaxin (30 µg/kg/day 20-h infusion and 4-h post-infusion period) in patients with acute heart failure (AHF). Methods and results This double-blind, multicentre study randomized 71 AHF patients with pulmonary capillary wedge pressure (PCWP) ≥18 mmHg, systolic blood pressure (BP) ≥115 mmHg, and estimated glomerular filtration rate ≥30 mL/min/1.73 m2 to serelaxin (n = 34) or placebo (n = 37) within 48 h of hospitalization. Co-primary endpoints were peak change from baseline in PCWP and cardiac index (CI) during the first 8 h of infusion. Among 63 patients eligible for haemodynamic analysis (serelaxin, n = 32; placebo, n = 31), those treated with serelaxin had a significantly higher decrease in peak PCWP during the first 8 h of infusion (difference vs. placebo: −2.44 mmHg, P = 0.004). Serelaxin showed no significant effect on the peak change in CI vs. placebo. Among secondary haemodynamic endpoints, a highly significant reduction in pulmonary artery pressure (PAP) was observed throughout the serelaxin infusion (largest difference in mean PAP vs. placebo: −5.17 mmHg at 4 h, P < 0.0001). Right atrial pressure, systemic/pulmonary vascular resistance, and systolic/diastolic BP decreased from baseline with serelaxin vs. placebo and treatment differences reached statistical significance at some time points. Serelaxin administration improved renal function and decreased N-terminal pro-brain natriuretic peptide levels vs. placebo. Treatment with serelaxin was well tolerated with no apparent safety concerns. Conclusion The haemodynamic effects of serelaxin observed in the present study provide plausible mechanistic support for improvement in signs and symptoms of congestion observed with this agent in AHF patients. ClinicalTrials.gov identifier NCT01543854. PMID:24255129

  5. A multicentre cluster-randomized controlled study to evaluate a train-the-trainer programme for implementing internal and external participation in medical rehabilitation.

    Science.gov (United States)

    Koerner, Mirjam; Wirtz, Markus; Michaelis, Martina; Ehrhardt, Heike; Steger, Anne-Kathrin; Zerpies, Eva; Bengel, Jürgen

    2014-01-01

    Evaluation of the effect of the train-the-trainer programme 'Fit for Shared Decision-Making' on internal (team) and external (patient) participation in medical rehabilitation from a patient and staff perspective. A multicentre, cluster-randomized controlled study. Eleven medical rehabilitation clinics, divided into intervention and control groups. A staff and a patient survey were conducted pre- and post-intervention, plus a further patient survey six months later. Train-the-trainer programme 'Fit for Shared Decision-Making' for interprofessional settings. Each survey measured internal participation with a self-compiled six-item scale (Internal Participation Scale, IPS), and external participation by means of a nine-item Shared Decision-Making Questionnaire (SDM-Q-9) for the patients and for healthcare professionals. Patient samples numbered 402 for the pre-, 463 for the post-intervention data collection period and 461 six months after the intervention. Patients' appraisal of external participation (Fperiod x group (2) = 0.256, p=0.774, η(2)=0.000) showed no change, whereas internal participation (Fperiod x group (2) = 3.785, p=0.023, η(2)=0.007) showed a significant increase. A total of 195 healthcare professionals participated in the pre- and 168 in the post-intervention staff survey. Here external participation was significantly enhanced in the intervention group (F(period x group) (1) = 4.893, p=0.028, η(2)=0.014). The train-the-trainer approach can be recommended for implementing internal and external participation in interprofessional settings such as medical rehabilitation clinics. However, there is a need for more intensive staff training for internal participation and an additional intervention for patients to achieve success in all aspects.

  6. Stop or go? Preventive cognitive therapy with guided tapering of antidepressants during pregnancy: study protocol of a pragmatic multicentre non-inferiority randomized controlled trial.

    Science.gov (United States)

    Molenaar, Nina M; Brouwer, Marlies E; Bockting, Claudi L H; Bonsel, Gouke J; van der Veere, Christine N; Torij, Hanneke W; Hoogendijk, Witte J G; Duvekot, Johannes J; Burger, Huibert; Lambregtse-van den Berg, Mijke P

    2016-03-18

    Approximately 6.2 % of women in the USA and 3.7 % of women in the UK, use Selective Serotonin Reuptake Inhibitors (SSRIs) during their pregnancies because of depression and/or anxiety. In the Netherlands, this prevalence is around 2 %. Nonetheless, SSRI use during pregnancy is still controversial. On the one hand SSRIs may be toxic to the intrauterine developing child, while on the other hand relapse or recurrence of depression during pregnancy poses risks for both mother and child. Among patients and professionals there is an urgent need for evidence from randomized studies to make rational decisions regarding continuation or tapering of SSRIs during pregnancy. At present, no such studies exist. 'Stop or Go' is a pragmatic multicentre randomized non-inferiority trial among 200 pregnant women with a gestational age of less than 16 weeks who use SSRIs without clinically relevant depressive symptoms. Women allocated to the intervention group will receive preventive cognitive therapy with gradual, guided discontinuation of SSRIs under medical management (STOP). Women in the control group will continue the use of SSRIs (GO). Primary outcome will be the (cumulative) incidence of relapse or recurrence of maternal depressive disorder (as assessed by the Structured Clinical Interview for DSM disorders) during pregnancy and up to three months postpartum. Secondary outcomes will be child outcome (neonatal outcomes and psychomotor and behavioural outcomes up to 24 months postpartum), and health-care costs. Total study duration for participants will be therefore be 30 months. We specified a non-inferiority margin of 15 % difference in relapse risk. This study is the first to investigate the effect of guided tapering of SSRIs with preventive cognitive therapy from early pregnancy onwards as compared to continuation of SSRIs during pregnancy. We will study the effects on both mother and child with a pragmatic approach. Additionally, the study examines cost effectiveness. If non

  7. Electroacupuncture at Qiuxu (GB 40) for Treatment of Migraine——A Clinical Multicentral Random Controlled Study

    Institute of Scientific and Technical Information of China (English)

    JIA Chun-sheng; MA Xiao-shun; SHI Jing; WANG Yao-min; LI Yong-fang; YUAN Jun; LI Mei; ZHENG Li-xing; ZHANG Xiang-jian; WANG Shao-jin; GAO Jian-ying; LI Xiao-feng; HUO Yong-li

    2009-01-01

    To observe the therapeutic effects of electroacupuncture (EA) at Qiuxu (GB 40) for treatment of migraine so as to provide clinical evidence for compilation of the Acupoints' Dictionary of the People's Republic of China. Methods: 275 migraine patients admitted in 3 hospitals were randomly divided into a treatment group treated by EA at Qiuxu (GB 40),and a control group treated by EA at Tianshu (ST 25). The indexes of the migraine symptoms and the 5-HT level were observed in both the groups before and after treatment. Results: There was an significant difference in VAS score between the two groups of the 3 clinical centers (P<0.01). The therapeutic effects of a 4-week treatment were much better in the treatment group than that of the control group. The 3-month follow-up survey showed that the long-term effects were in favor of the treatment group of the first and third clinical centers,though no significant difference was found in the treatment group of the second clinical center as compared with the control group. The results from the 6-month follow-up survey showed better effects in the treatment group of all the 3 clinical centers.Conclusion: EA at Qiuxu (GB 40) may show effect for migraine.

  8. A multicentre randomized controlled trial of an empowerment-inspired intervention for adolescents starting continuous subcutaneous insulin infusion--a study protocol.

    Science.gov (United States)

    Brorsson, Anna Lena; Leksell, Janeth; Viklund, Gunnel; Lindholm Olinder, Anna

    2013-12-20

    Continuous subcutaneous insulin infusion (CSII) treatment among children with type 1 diabetes is increasing in Sweden. However, studies evaluating glycaemic control in children using CSII show inconsistent results. The distribution of responsibility for diabetes self-management between children and parents is often unclear and needs clarification. There is much published support for continued parental involvement and shared diabetes management during adolescence. Guided Self-Determination (GSD) is an empowerment-based, person-centred, reflection and problem solving method intended to guide the patient to become self-sufficient and develop life skills for managing difficulties in diabetes self-management. This method has been adapted for adolescents and parents as Guided Self-Determination-Young (GSD-Y). This study aims to evaluate the effect of an intervention with GSD-Y in groups of adolescents starting on insulin pumps and their parents on diabetes-related family conflicts, perceived health and quality of life (QoL), and metabolic control. Here, we describe the protocol and plans for study enrollment. This study is designed as a randomized, controlled, prospective, multicentre study. Eighty patients between 12-18 years of age who are planning to start CSII will be included. All adolescents and their parents will receive standard insulin pump training. The education intervention will be conducted when CSII is to be started and at four appointments in the first 4 months after starting CSII. The primary outcome is haemoglobin A1c levels. Secondary outcomes are perceived health and QoL, frequency of blood glucose self-monitoring and bolus doses, and usage of carbohydrate counting. The following instruments will be used: Disabkids, 'Check your health', the Diabetes Family Conflict Scale and the Swedish Diabetes Empowerment Scale. Outcomes will be evaluated within and between groups by comparing data at baseline, and at 6 and 12 months after starting treatment. In this

  9. Reduction of relapses of atopic dermatitis with methylprednisolone aceponate cream twice weekly in addition to maintenance treatment with emollient: a multicentre, randomized, double-blind, controlled study.

    Science.gov (United States)

    Peserico, A; Städtler, G; Sebastian, M; Fernandez, R Suarez; Vick, K; Bieber, T

    2008-04-01

    The relapsing nature of atopic dermatitis (AD) presents a challenge for its long-term treatment. Efficacy and safety of corticosteroids have been proven in the acute treatment of active AD, but their long-term efficacy and potential to reduce or prevent relapses have only partially been addressed. To investigate long-term management (16 weeks) of AD with methylprednisolone aceponate (MPA) 0.1% cream twice weekly in addition to an emollient (Advabase((R))) after stabilization of an acute severe or very severe flare of AD with MPA cream. Patients > or = 12 years of age with a > or = 2-year history of moderate to severe AD were eligible for this multicentre, randomized, double-blind, controlled study if they presented with an acute flare of severe or very severe AD [Investigator's Global Assessment (IGA) score > or = 4]. After successful treatment of the flare in an acute phase (AP), patients received either MPA twice weekly plus emollient or emollient alone over a 16-week maintenance phase (MP). The primary study endpoint was time to relapse of AD. Secondary endpoints included relapse rate and disease status, the patient's assessment of intensity of itch, the Eczema Area and Severity Index, the IGA score, affected body surface area, Dermatology Life Quality Index (DLQI) and children's DLQI (CDLQI), patient's and investigator's global assessment of response and patient's assessment of quality of sleep. Two hundred and forty-nine patients entered the AP and 221 continued into the MP. Time to relapse was longer in the MPA group than in the emollient group. The probability of remaining free from relapse after 16 weeks was 87.1% in the MPA group compared with 65.8% for the emollient. Patients treated with MPA twice weekly had a 3.5-fold lower risk of experiencing a relapse than patients treated with emollient alone (hazard ratio 3.5, 95% confidence interval 1.9-6.4; P emollient for all other efficacy endpoints. Therapy with both treatments was well tolerated. MPA twice

  10. Corticosteroid contact allergy: an EECDRG multicentre study

    DEFF Research Database (Denmark)

    Dooms-Goossens, A; Andersen, Klaus Ejner; Brandäo, F M;

    1996-01-01

    This article describes the results of an EECDRG multicentre study on contact allergy to corticosteroids. A total of 7238 patients were investigated: 6238 in 13 centres in the course of 1993, and 1000 patients in 1 centre in 1993 and 1994. The 5 corticosteroids tested were budesonide 0.1% pet......., betamethasone-17-valerate 1% pet., clobetasol-17-propionate 1% pet., hydrocortisone-17-butyrate 1% eth., and tixocortol-21-pivalate 1% pet.; 189 (2.6%) gave a positive patchtest reaction (+, ++, + + +) to at least 1 of the corticosteroids. The data regarding the corticosteroid-sensitive patients, as well...

  11. Multicentre study of haemodialysis costs.

    Science.gov (United States)

    Parra Moncasi, E; Arenas Jiménez, M D; Alonso, M; Martínez, M F; Gámen Pardo, A; Rebollo, P; Ortega Montoliú, T; Martínez Terrer, T; Alvarez-Ude, F

    2011-01-01

    Previous studies to determine the cost of haemodialysis (HD) in Spain have significant limitations: they are outdated or used indirect methods. There is also a lack of analysis performed simultaneously on Public centres (PC), with direct HD services, and partially state-subsidised centres (SC). This is an important issue since the two systems coexist in Spain. To estimate the cost of HD replacement therapy for chronic renal failure in several centres. This is a prospective and publicly-funded study, which estimates the costs for 2008 using a cost accounting system with specific allocation criteria. We collected demographic and comorbidity data for each centre. Six centres participated, two PC and four SC. There were no significant differences between centres in terms of patient demographics, time on haemodialysis and the Charlson comorbidity index. The total cost per patient per year ranged between € 46, 254 and € 33,130. The cost per patient per year (excluding vascular access and hospital admission) for PC was € 42, 547 and € 39, 289 and for SC € 32 872, € 29, 786, € 35, 461 and € 35, 294 (23% more in PC than SC). Costs related to staff/patient/year and consumables/patient/year were 67% and 83% respectively, higher for PC than SC. The highest percentage cost was for staff (average 30.9%), which showed significant variability between centres, both in absolute numbers (staff cost per patient per year between € 18,151 and € 8504) and as a percentage (between 42.6 % and 25.4%). Cost variability exists among different HD centres, and this can be attributed primarily to staff and consumables costs, which is higher for PC than SC.

  12. Genitourinary brucellosis: results of a multicentric study.

    Science.gov (United States)

    Erdem, H; Elaldi, N; Ak, O; Gulsun, S; Tekin, R; Ulug, M; Duygu, F; Sunnetcioglu, M; Tulek, N; Guler, S; Cag, Y; Kaya, S; Turker, N; Parlak, E; Demirdal, T; Ataman Hatipoglu, C; Avci, A; Bulut, C; Avci, M; Pekok, A; Savasci, U; Kaya, S; Sozen, H; Tasbakan, M; Guven, T; Bolukcu, S; Cesur, S; Sahin-Horasan, E; Kazak, E; Denk, A; Gonen, I; Karagoz, G; Haykir Solay, A; Alici, O; Kader, C; Senturk, G; Tosun, S; Turan, H; Baran, A I; Ozturk-Engin, D; Bozkurt, F; Deveci, O; Inan, A; Kadanali, A; Sayar, M S; Cetin, B; Yemisen, M; Naz, H; Gorenek, L; Agalar, C

    2014-11-01

    This study reviewed the clinical, laboratory, therapeutic and prognostic data on genitourinary involvement of brucellosis in this largest case series reported. This multicentre study pooled adult patients with genitourinary brucellar involvement from 34 centres treated between 2000 and 2013. Diagnosis of the disease was established by conventional methods. Overall 390 patients with genitourinary brucellosis (352 male, 90.2%) were pooled. In male patients, the most frequent involved site was the scrotal area (n=327, 83.8%), as epididymo-orchitis (n=204, 58%), orchitis (n=112, 31.8%) and epididymitis (n=11, 3.1%). In female patients, pyelonephritis (n=33/38, 86.8%) was significantly higher than in male patients (n=11/352, 3.1%; pbrucellosis occurred in one patient. A localized scrotal infection in men or pyelonephritis in women in the absence of leucocytosis and with mild to moderate increases in inflammatory markers should signal the possibility of brucellar genitourinary disease.

  13. Effects of unstratified and centre-stratified randomization in multi-centre clinical trials.

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

    This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed.

  14. Design of a multicentre randomized trial to evaluate CT colonography versus colonoscopy or barium enema for diagnosis of colonic cancer in older symptomatic patients: The SIGGAR study

    Directory of Open Access Journals (Sweden)

    Edwards Rob

    2007-10-01

    Full Text Available Abstract Background and Aims The standard whole-colon tests used to investigate patients with symptoms of colorectal cancer are barium enema and colonoscopy. Colonoscopy is the reference test but is technically difficult, resource intensive, and associated with adverse events, especially in the elderly. Barium enema is safer but has reduced sensitivity for cancer. CT colonography ("virtual colonoscopy" is a newer alternative that may combine high sensitivity for cancer with safety and patient acceptability. The SIGGAR trial aims to determine the diagnostic efficacy, acceptability, and economic costs associated with this new technology. Methods The SIGGAR trial is a multi-centre randomised comparison of CT colonography versus standard investigation (barium enema or colonoscopy, the latter determined by individual clinician preference. Diagnostic efficacy for colorectal cancer and colonic polyps measuring 1 cm or larger will be determined, as will the physical and psychological morbidity associated with each diagnostic test, the latter via questionnaires developed from qualitative interviews. The economic costs of making or excluding a diagnosis will be determined for each diagnostic test and information from the trial and other data from the literature will be used to populate models framed to summarise the health effects and costs of alternative approaches to detection of significant colonic neoplasia in patients of different ages, prior risks and preferences. This analysis will focus particularly on the frequency, clinical relevance, costs, and psychological and physical morbidity associated with detection of extracolonic lesions by CT colonography. Results Recruitment commenced in March 2004 and at the time of writing (July 2007 5025 patients have been randomised. A lower than expected prevalence of end-points in the barium enema sub-trial has caused an increase in sample size. In addition to the study protocol, we describe our approach to

  15. Efficacy and safety of a single botulinum type A toxin complex treatment (Dysport) for the relief of upper back myofascial pain syndrome: results from a randomized double-blind placebo-controlled multicentre study.

    Science.gov (United States)

    Göbel, Hartmut; Heinze, Axel; Reichel, Gerhard; Hefter, Harald; Benecke, Reiner

    2006-11-01

    Botulinum type A toxin (BoNT-A) has antinociceptive and muscle-relaxant properties and may help relieve the symptoms of myofascial pain syndrome. In this study we evaluated the efficacy and tolerability of BoNT-A (Dysport) in patients with myofascial pain syndrome of the upper back. We conducted a prospective, randomized, double-blind, placebo-controlled, 12-week, multicentre study. Patients with moderate-to-severe myofascial pain syndrome affecting cervical and/or shoulder muscles (10 trigger points, disease duration 6-24 months) were randomized to Dysport or saline. Injections were made into the 10 most tender trigger points (40 units per site). The primary outcome was the proportion of patients with mild or no pain at week 5. Secondary outcomes included changes in pain intensity and the number of pain-free days per week. Tolerability and safety were also assessed. At week 5, significantly more patients in the Dysport group reported mild or no pain (51%), compared with the patients in the placebo group (26%; p=0.002). Compared with placebo, Dysport resulted in a significantly greater change from baseline in pain intensity during weeks 5-8 (ppain between weeks 5 and 12 (p=0.036). Treatment was well tolerated, with most side effects resolving within 8 weeks. In conclusion, in patients with upper back myofascial pain syndrome, injections of 400 Ipsen units of Dysport at 10 individualised trigger points significantly improved pain levels 4-6 weeks after treatment. Injections were well tolerated.

  16. Survival analysis of the CEAwatch multicentre clustered randomized trial

    NARCIS (Netherlands)

    Verberne, C. J.; Zhan, Z.; van den Heuvel, E. R.; Oppers, F.; de Jong, A. M.; Grossmann, Irene; Klaase, J. M.; de Bock, G. H.; Wiggers, T.

    2017-01-01

    Background: The CEAwatch randomized trial showed that follow-up with intensive carcinoembryonic antigen (CEA) monitoring (CEAwatch protocol) was better than care as usual (CAU) for early postoperative detection of colorectal cancer recurrence. The aim of this study was to calculate overall survival

  17. [Cycloferon, as an agent in the therapy and urgent prophylaxis of influenza and acute respiratory tract viral infection (multicentre randomized controlled comparative study)].

    Science.gov (United States)

    Sologub, T V; Shul'diakov, A A; Romantsov, M G; Zhekalov, A N; Petlenko, S V; Erofeeva, M K; Maksakova, V L; Isakov, V A; Zarubaev, V V; Gatsan, V V; Kovalenko, A L

    2009-01-01

    Data on the study of the efficacy of the tablets of cycloferon, an early inductor of types 1 and 2 interferon, in the treatment of influenza and acute respiratory tract viral infections in adults are presented. The study enrolled 522 patients with moderate influenza of type A (H1N1) verified in 61% of the patients and type A (H3N2) verified in 7.5% of the cases. The patients were randomized with the envelope procedure. In the patients treated with cycloferon the intensity and period of the fever were stopped earlier and averaged from 1.8 to 3 days vs. 5 days in the reference group (symptomatic therapy). The improvement signs in the general state of the patients treated with cycloferon were noted on the 2nd day. The influenza complication as pneumonia was recorded in 2.2% of the patients treated with cycloferon, whereas in the patients under the symptomatic therapy the complications as bronchitis, pneumonia, angina were stated in 21.4% of the cases. For urgent prophylaxis of the influenza and respiratory tract viral infections (epidemiologic study) a group of 3717 subjects randomized with the table of random numbers was observed. 2080 patients were treated with cycloferon and 1637 patients were under the symptomatic therapy. The results were evaluated by the efficacy index and the protection estimate (T. A. Semenenko, 1991). The total efficacy index and the protection estimate in all the patients of the group were 4.9 and 79.8% respectively. The complicated forms of the disease were recorded in 1.5% of the patients treated with cycloferon and in 10.5 and 11.3% of the patients not treated with cycloferon.

  18. Pulmonary infection control window in treatment of severe respiratory failure of chronic obstructive pulmonary diseases: a prospective, randomized controlled, multi-centred study

    Institute of Scientific and Technical Information of China (English)

    Collaborating Research Group for Noninvasive Mecha

    2005-01-01

    Background Early withdraw from invasive mechanical ventilation (MV) followed by noninvasive MV is a new strategy for changing modes of treatment. This study was conducted to estimate the feasibility and the efficacy of early extubation and sequential noninvasive MV commenced at beginning of pulmonary infection control window in patients with exacerbated hypercapnic respiratory failure caused by chronic obstructive pulmonary diseases (COPD). Methods A prospective, randomized controlled study was conducted in eleven teaching hospitals' respiratory or medical intensive care units in China. Ninety intubated COPD patients with severe hypercapnic respiratory failure triggered by pulmonary infection (pneumonia or purulent bronchitis) were involved in the study. When the pulmonary infection had been controlled by antibiotics and comprehensive therapy, the "pulmonary infection control window (PIC window)" has been reached. Each case was randomly assigned to study group (extubation and noninvasive MV via facial mask immediately) or control group (invasive MV was received continuously after PIC window by using conventional weaning technique).Results Study group (n=47) and control group (n=43) had similar clinical characteristics initially and at the time of PIC window. Compared with control group, study group had shorter duration of invasive MV [(6.4±4.4) days vs (11.3±6.2) days, P=0.000], lower rate of ventilator associated pneumonia (VAP) (3/47 vs 12/43, P=0.014), fewer days in ICU [(12±8) days vs (16±11) days, P=0.047] and lower hospital mortality (1/47 vs 7/43, P=0.025).Conclusions In COPD patients requiring intubation and invasive MV for hypercapnic respiratory failure, which is exacerbated by pulmonary infection, early extubation followed by noninvasive MV initiated at the start of PIC window may decrease significantly the duration of invasive MV, the risk of VAP and hospital mortality.

  19. Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arnaud Nicolas

    2012-09-01

    Full Text Available Abstract Background Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. Methods/design To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400 or an assessment only control group (N = 400 depending on their screening for risky substance use (using the CRAFFT. Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent–child relationship. Discussion The trial is expected to contribute to the growing literature on theory- and web-based brief interventions

  20. Switching to aripiprazole in outpatients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues with risperidone: a randomized, multicentre, open-label study.

    Science.gov (United States)

    Ryckmans, V; Kahn, J P; Modell, S; Werner, C; McQuade, R D; Kerselaers, W; Lissens, J; Sanchez, R

    2009-05-01

    This study evaluated the safety/tolerability and effectiveness of aripiprazole titrated-dose versus fixed-dose switching strategies from risperidone in patients with schizophrenia experiencing insufficient efficacy and/or safety/tolerability issues. Patients were randomized to an aripiprazole titrated-dose (starting dose 5 mg/day) or fixed-dose (dose 15 mg/day) switching strategy with risperidone down-tapering. Primary endpoint was rate of discontinuation due to adverse events (AEs) during the 12-week study. Secondary endpoints included positive and negative syndrome scale (PANSS), clinical global impressions - improvement of illness scale (CGI-I), preference of medication (POM), subjective well-being under neuroleptics (SWN-K) and GEOPTE (Grupo Español para la Optimización del Tratamiento de la Esquizofrenia) scales. Rates of discontinuations due to AEs were similar between titrated-dose and fixed-dose strategies (3.5% vs. 5.0%; p=0.448). Improvements in mean PANSS total scores were similar between aripiprazole titrated-dose and fixed-dose strategies (-14.8 vs. -17.2; LOCF), as were mean CGI-I scores (2.9 vs. 2.8; p=0.425; LOCF) and SWN-K scores (+8.6 vs.+10.3; OC,+7.8 vs.+9.8; LOCF). Switching can be effectively and safely achieved through a titrated-dose or fixed-dose switching strategy for aripiprazole, with down-titration of risperidone.

  1. Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study.

    Science.gov (United States)

    Yu, K-H; Lai, J-H; Hsu, P-N; Chen, D-Y; Chen, C-J; Lin, H-Y

    2016-07-01

    This phase IIIB study compared the efficacy and safety of febuxostat and allopurinol in gout patients with or without tophi who were HLA-B*5801 negative. Eligible patients were randomized to a febuxostat group (80 mg QD) or an allopurinol group (300 mg QD). Following an initial 2-week washout period, over the next 12 weeks we made five measurements of serum urate levels along with assessments of adverse events (AEs). Forty-three out of 152 screened subjects (28.3%) were ineligible either because of the presence of the HLA-B*5801 allele or for various other reasons. The febuxostat group (n = 54) and the allopurinol group (n = 55) had no significant differences in demographic or baseline characteristics. From week 2 to week 12, the febuxostat group had a significantly lower serum urate level than the allopurinol group (p ≤ 0.001 for all comparisons) and significantly more patients with serum urate levels less than 6.0 mg/dL. The serum urate levels of the febuxostat group declined by more than 40% from week 2 to week 12 and this decrease was greater than that in the allopurinol group (~30%). The two groups were similar in terms of AEs. Febuxostat was more effective than allopurinol in reducing the serum urate levels of Han Chinese patients with gout or tophaceous gout who were HLA-B*5801 negative, without causing any serious skin reactions. Febuxostat should be considered for treatment of Han Chinese patients with gout who are HLA-B*5801 negative.

  2. ‘Placement budgets’ for supported employment – improving competitive employment for people with mental illness: study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Nordt Carlos

    2012-10-01

    Full Text Available Abstract Background Vocational integration of people with mental illness is poor despite their willingness to work. The ‘Individual Placement and Support’ (IPS model which emphasises rapid and direct job placement and continuing support to patient and employer has proven to be the most effective vocational intervention programme. Various studies have shown that every second patient with severe mental illness was able to find competitive employment within 18 months. However, the goal of taking up employment within two months was rarely achieved. Thus, we aim to test whether the new concept of limited placement budgets increases the effectiveness of IPS. Methods/Design Six job coaches in six out-patients psychiatric clinics in the Canton of Zurich support unemployed patients of their clinic who seek competitive employment. Between June 2010 and May 2011 patients (N=100 are randomly assigned to three different placement budgets of 25h, 40h, or 55h working hours of job coaches. Support lasts two years for those who find a job. The intervention ends for those who fail to find competitive employment when the respective placement budgets run out. The primary outcome measure is the time between study inclusion and first competitive employment that lasted three months or longer. Over a period of three years interviews are carried out every six months to measure changes in motivation, stigmatization, social network and social support, quality of life, job satisfaction, financial situation, and health conditions. Cognitive and social-cognitive tests are conducted at baseline to control for confounding variables. Discussion This study will show whether the effectiveness of IPS can be increased by the new concept of limited placement budgets. It will also be examined whether competitive employment leads in the long term to an improvement of mental illness, to a transfer of the psychiatric support system to private and vocational networks, to an increase

  3. 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...

  4. Anger management for people with mild to moderate learning disabilities: Study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff

    Directory of Open Access Journals (Sweden)

    Nuttall Jacqueline

    2011-02-01

    Full Text Available Abstract Background Cognitive behaviour therapy (CBT is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision. Methods/Design This is a multi-centre cluster randomized controlled trial of a group intervention versus a 'support as usual' waiting-list control group, with randomization at the level of the group. Outcomes will be assessed at the end of the intervention and again 6-months later. After completion of the 6-month follow-up assessments, the intervention will also be delivered to the waiting-list groups. The study will include a range of anger/aggression and mental health measures, some of which will be completed by service users and also by their day service key-workers and by home carers. Qualitative data will be collected to assess the impact of the intervention on participants, lay therapists, and services, and the study will also include a service-utilization cost and consequences analysis. Discussion This will be the first trial to investigate formally how effectively staff working in services providing day activities for people with learning disabilities are able to use a therapy manual to deliver a CBT based anger management intervention, following brief training by a Clinical Psychologist. The demonstration that service staff can successfully deliver anger management to people with learning disabilities, by widening the pool of potential therapists, would have

  5. Anger management for people with mild to moderate learning disabilities: study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff.

    Science.gov (United States)

    Willner, Paul; Jahoda, Andrew; Rose, John; Stenfert-Kroese, Biza; Hood, Kerenza; Townson, Julia K; Nuttall, Jacqueline; Gillespie, David; Felce, David

    2011-02-09

    Cognitive behaviour therapy (CBT) is the treatment of choice for common mental health problems, but this approach has only recently been adapted for people with learning disabilities, and there is a limited evidence base for the use of CBT with this client group. Anger treatment is the one area where there exists a reasonable number of small controlled trials. This study will evaluate the effectiveness of a manualized 12-week CBT intervention for anger. The intervention will be delivered by staff working in the day services that the participants attend, following training to act as 'lay therapists' by a Clinical Psychologist, who will also provide supervision. This is a multi-centre cluster randomized controlled trial of a group intervention versus a 'support as usual' waiting-list control group, with randomization at the level of the group. Outcomes will be assessed at the end of the intervention and again 6-months later. After completion of the 6-month follow-up assessments, the intervention will also be delivered to the waiting-list groups. The study will include a range of anger/aggression and mental health measures, some of which will be completed by service users and also by their day service key-workers and by home carers. Qualitative data will be collected to assess the impact of the intervention on participants, lay therapists, and services, and the study will also include a service-utilization cost and consequences analysis. This will be the first trial to investigate formally how effectively staff working in services providing day activities for people with learning disabilities are able to use a therapy manual to deliver a CBT based anger management intervention, following brief training by a Clinical Psychologist. The demonstration that service staff can successfully deliver anger management to people with learning disabilities, by widening the pool of potential therapists, would have very significant benefits in relation to the current policy of

  6. Conducting a multicentre and multinational qualitative study on patient transitions.

    Science.gov (United States)

    Johnson, Julie K; Barach, Paul; Vernooij-Dassen, Myrra

    2012-12-01

    A multicentre, multinational research study requires careful planning and coordination to accomplish the aims of the study and to ensure systematic and rigorous examination of all project methods and data collected. The aim of this paper is to describe the approach we used during the HANDOVER Project to develop a multicentre, multinational research project for studying transitions of patient care while creating a community of practice for the researchers. We highlight the process used to assure the quality of a multicentre qualitative study and to create a codebook for data analysis as examples of attending to the community of practice while conducting rigorous qualitative research. Essential elements for the success of this multinational, multilanguage research project included recruiting a strong research team, explicit planning for decision-making processes to be used throughout the project, acknowledging the differences among the study settings and planning the protocols to capitalise upon those differences. Although not commonly discussed in reports of large research projects, there is an underlying, concurrent stream of activities to develop a cohesive team that trusts and respects one another's skills and that engage independent researchers in a group process that contributes to achieving study goals. We discuss other lessons learned and offer recommendations for other teams planning multicentre research.

  7. Taurolidine reduces the tumor stimulating cytokine interleukin-1beta in patients with resectable gastrointestinal cancer: a multicentre prospective randomized trial

    Directory of Open Access Journals (Sweden)

    Mueller Joachim M

    2009-03-01

    Full Text Available Abstract Background The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear. Taurolidine and Povidone-iodine have been mainly used for abdominal lavage in Germany and Europe. Methods In the settings of a multicentre (three University Hospitals prospective randomized controlled trial 120 patients were randomly allocated to receive either 0.5% taurolidine/2,500 IU heparin (TRD or 0.25% povidone-iodine (control intraperitoneally for resectable colorectal, gastric or pancreatic cancers. Due to the fact that IL-1beta (produced by macrophages is preoperatively indifferent in various gastrointestinal cancer types our major outcome criterion was the perioperative (overall level of IL-1beta in peritoneal fluid. Results Cytokine values were significantly lower after TRD lavage for IL-1beta, IL-6, and IL-10. Perioperative complications did not differ. The median follow-up was 50.0 months. The overall mortality rate (28 vs. 25, p = 0.36, the cancer-related death rate (17 vs. 19, p = .2, the local recurrence rate (7 vs. 12, p = .16, the distant metastasis rate (13 vs. 18, p = 0.2 as well as the time to relapse were not statistically significant different. Conclusion Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD. But, this study analyzed different types of cancer. Therefore, we set up a multicentre randomized trial in patients undergoing curative colorectal cancer resection. Trial registration ISRCTN66478538

  8. Taurolidine reduces the tumor stimulating cytokine interleukin-1beta in patients with resectable gastrointestinal cancer: a multicentre prospective randomized trial

    Science.gov (United States)

    Braumann, Chris; Gutt, Carsten N; Scheele, Johannes; Menenakos, Charalambos; Willems, Wilhelm; Mueller, Joachim M; Jacobi, Christoph A

    2009-01-01

    Background The effect of additional treatment strategies with antineoplastic agents on intraperitoneal tumor stimulating interleukin levels are unclear. Taurolidine and Povidone-iodine have been mainly used for abdominal lavage in Germany and Europe. Methods In the settings of a multicentre (three University Hospitals) prospective randomized controlled trial 120 patients were randomly allocated to receive either 0.5% taurolidine/2,500 IU heparin (TRD) or 0.25% povidone-iodine (control) intraperitoneally for resectable colorectal, gastric or pancreatic cancers. Due to the fact that IL-1beta (produced by macrophages) is preoperatively indifferent in various gastrointestinal cancer types our major outcome criterion was the perioperative (overall) level of IL-1beta in peritoneal fluid. Results Cytokine values were significantly lower after TRD lavage for IL-1beta, IL-6, and IL-10. Perioperative complications did not differ. The median follow-up was 50.0 months. The overall mortality rate (28 vs. 25, p = 0.36), the cancer-related death rate (17 vs. 19, p = .2), the local recurrence rate (7 vs. 12, p = .16), the distant metastasis rate (13 vs. 18, p = 0.2) as well as the time to relapse were not statistically significant different. Conclusion Reduced cytokine levels might explain a short term antitumorigenic intraperitoneal effect of TRD. But, this study analyzed different types of cancer. Therefore, we set up a multicentre randomized trial in patients undergoing curative colorectal cancer resection. Trial registration ISRCTN66478538 PMID:19309495

  9. The TRAPIST Study. A multicentre randomized placebo controlled clinical trial of trapidil for prevention of restenosis after coronary stenting, measured by 3-D intravascular ultrasound.

    NARCIS (Netherlands)

    P.W.J.C. Serruys (Patrick); D.P. Foley (David); M. Pieper (Michael); J.A. Kleijne; P.J. de Feyter (Pim)

    2001-01-01

    textabstractBACKGROUND: Studies have reported benefit of oral therapy with the phosphodiesterase inhibitor, trapidil, in reducing restenosis after coronary angioplasty. Coronary stenting is associated with improved late outcome compared with balloon angioplasty, but significant neointimal hyperplasi

  10. Pharmacological cardioversion of atrial fibrillation--a double-blind, randomized, placebo-controlled, multicentre, dose-escalation study of AZD1305 given intravenously

    DEFF Research Database (Denmark)

    Rónaszéki, Aladár; Alings, Marco; Egstrup, Kenneth

    2011-01-01

    AZD1305 is a combined ion channel blocker developed for the treatment of atrial fibrillation (AF). The aim of this study was to determine whether AZD1305 was effective in converting AF to sinus rhythm (SR)....

  11. [Multicentric prospective randomized study evaluating the interest of intravaginal electro-stimulation at home for urinary incontinence after prior perineal reeducation. Interim analysis].

    Science.gov (United States)

    Lopès, P; Levy-Toledano, R; Chiarelli, P; Rimbault, F; Marès, P

    2014-03-01

    Perineal reeducation of stress urinary incontinence is beneficial in 80% of cases. However, patients have to perform self-retraining exercises of the perineal muscles at home, in order to maintain the benefit of the physiotherapy. The aim of this study is to assess the benefit of GYNEFFIK(®), a perineal electro-stimulator, during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI) that responded to physiotherapy were included in this study in two parallel groups. The groups followed a self-reeducation program, with or without GYNEFFIK(®) electro-stimulation sessions. The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained (defined as non-worsening ICIQ and Ditrovie scales' score). According to the protocol, an interim analysis was performed on 95 patients (i.e. almost half of the expected sample size) who had had at least one evaluation under treatment, among which 44 patients had finished the study. The therapeutic benefit of the initial perineal reeducation was maintained in 87.8% of the GYNEFFIK(®) patient group, while it was maintained in 52.2% (P=0.0001) in the usual care group (i.e. who did not use electro-stimulation). Likewise, patient had a more favorable subjective impression when using GYNEFFIK(®) (83.7% versus 60.0% in the usual care group) as they felt that they improved during the study. In the GYNEFFIK(®) group, no increase in symptoms was reported, whereas almost one out of five patients in the usual care group felt that their condition had worsened. Copyright © 2014. Published by Elsevier SAS.

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

    OpenAIRE

    Kraft Matthias; Kraft Kathleen; Gärtner Simone; Mayerle Julia; Simon Peter; Weber Eckhard; Schütte Kerstin; Stieler Jens; Koula-Jenik Heide; Holzhauer Peter; Gröber Uwe; Engel Georg; Müller Cornelia; Feng You-Shan; Aghdassi Ali

    2012-01-01

    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)...

  13. Double-blind, randomized, multicentre, and active comparator controlled investigation of the effect of Pioglitazone, Metformin, and the combination of both on cardiovascular risk in patients with type 2 diabetes receiving stable basal insulin therapy: the PIOCOMB study

    Directory of Open Access Journals (Sweden)

    Kleine Iris

    2011-07-01

    Full Text Available Abstract Background We analyzed specific effects of an add-on therapy with pioglitazone compared to metformin and their combination in patients with basal insulin treatment on biomarkers of CV risk. Methods In this double-blind, randomized, multicentre, active comparator controlled trial, 121 patients with type 2 diabetes were enrolled. Inclusions: treatment with basal insulin, HbA1C 6.5% - 8.5%, age 30 - 75 years. After glargine therapy over 2 weeks for titration towards FBG ≤ 7.8 mmol/L, patients received either (A bid 850 mg metformin (n = 42, (B bid 15 mg pioglitazone (n = 40, or (C 30 mg pioglitazone plus 1.7 g metformin (n = 39 over 6 months. Matrix Metal Proteinase 9 (MMP-9 was primary objective, together with biomarkers of CV risk. Results Pioglitazone (B reduced MMP-9 versus baseline by 54.1 + 187.1 ng/mL, with metformin (A it was increased by 49.6 + 336.2 ng/mL (p = 0.0345; B vs. A, and with the combination of both (C it was decreased by 67.8 + 231.4 ng/mL (A vs. C: p = 0.0416; B vs. C: p = 0.8695. After logarithmic transformation due to high variances the exploratory results showed significance for A vs. B (p = 0.0043 and for A vs. C (p = 0.0289. Insulin dosage was reduced by 7.3 units in group B (p 1C was only significantly decreased in the combination group. No significant effects were observed for NFkB and PGFα. peripheral edema were seen in 11.9% vs. 40.0% vs. 20.5%, and weight change was -0.7 kg vs. +4.3 kg vs. +2.7 kg (A vs. B vs. C. Conclusions Addition of pioglitazone but not of metformin reduces MMP-9, hs-CRP and increased insulin sensitivity and adiponectin in this study. The combination of both had no additional effect on inflammation. Pioglitazone is suggested to be a rational add-on therapy to basal insulin in patients with high CV risk.

  14. 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

  15. An integrated approach to consumer representation and involvement in a multicentre randomized controlled trial.

    Science.gov (United States)

    Langston, Anne L; McCallum, Marilyn; Campbell, Marion K; Robertson, Clare; Ralston, Stuart H

    2005-01-01

    Although, consumer involvement in individual studies is often limited, their involvement in guiding health research is generally considered to be beneficial. This paper outlines our experiences of an integrated relationship between the organisers of a clinical trial and a consumer organisation. The PRISM trial is a UK multicentre, randomized controlled trial comparing treatment strategies for Paget's disease of the bone. The National Association for the Relief of Paget's Disease (NARPD) is the only UK support group for sufferers of Paget's disease and has worked closely with the PRISM team from the outset. NARPD involvement is integral to the conduct of the trial and specific roles have included: peer-review; trial steering committee membership; provision of advice to participants, and promotion of the trial amongst Paget's disease patients. The integrated relationship has yielded benefits to both the trial and the consumer organisation. The benefits for the trial have included: recruitment of participants via NARPD contacts; well-informed participants; unsolicited patient advocacy of the trial; and interested and pro-active collaborators. For the NARPD and Paget's disease sufferers, benefits have included: increased awareness of Paget's disease; increased access to relevant health research; increased awareness of the NARPD services; and wider transfer of diagnosis and management knowledge to/from health care professionals. Our experience has shown that an integrated approach between a trial team and a consumer organisation is worthwhile. Adoption of such an approach in other trials may yield significant improvements in recruitment and quality of participant information flow. There are, however, resource implications for both parties.

  16. A three-year follow-up on the efficacy of psychosocial interventions for patients with mild dementia and their caregivers: the multicentre, rater-blinded, randomized Danish Alzheimer Intervention Study (DAISY)

    DEFF Research Database (Denmark)

    Phung, K.T.T.; Waldorff, F.B.; Buss, D.V.

    2013-01-01

    OBJECTIVES: To examine the long-term efficacy at the 36-month follow-up of an early psychosocial counselling and support programme lasting 8-12 months for community-dwelling patients with mild Alzheimer's disease and their caregivers. DESIGN: Multicentre, randomised, controlled, rater-blinded trial...... groups had follow-up visits at 3, 6, 12 and 36 months. MAIN OUTCOME MEASURES: Primary outcomes for the patients assessed at 36-month follow-up were changes from baseline in global cognitive function (Mini-Mental State Examination), depressive symptoms (Cornell Depression Scale) and proxy-rated Euro...... of Life Scale for Alzheimer's disease (QoL-AD), Neuropsychiatric Inventory-Questionnaire, Alzheimer's disease Cooperative Study Activities of Daily Living Scale, all-cause mortality and nursing home placement. RESULTS: At a 36-month follow-up, 2 years after the completion of the Danish Alzheimer...

  17. A three-year follow-up on the efficacy of psychosocial interventions for patients with mild dementia and their caregivers: the multicentre, rater-blinded, randomized Danish Alzheimer Intervention Study (DAISY)

    DEFF Research Database (Denmark)

    Phung, K.T.T.; Waldorff, F.B.; Buss, D.V.

    2013-01-01

    OBJECTIVES: To examine the long-term efficacy at the 36-month follow-up of an early psychosocial counselling and support programme lasting 8-12 months for community-dwelling patients with mild Alzheimer's disease and their caregivers. DESIGN: Multicentre, randomised, controlled, rater-blinded trial....... SETTING: Primary care and memory clinics in five Danish districts. PARTICIPANTS: 330 home-dwelling patients with mild Alzheimer's disease and their primary caregivers (dyads). INTERVENTIONS: Dyads were randomised to receive intervention during the first year after diagnosis. Both intervention and control...... of Life Scale for Alzheimer's disease (QoL-AD), Neuropsychiatric Inventory-Questionnaire, Alzheimer's disease Cooperative Study Activities of Daily Living Scale, all-cause mortality and nursing home placement. RESULTS: At a 36-month follow-up, 2 years after the completion of the Danish Alzheimer...

  18. Randomized multicentre pilot study of sacubitril/valsartan versus irbesartan in patients with chronic kidney disease: United Kingdom Heart and Renal Protection (HARP)- III-rationale, trial design and baseline data.

    Science.gov (United States)

    2016-09-19

    Patients with chronic kidney disease (CKD) are at risk of progression to end-stage renal disease and cardiovascular disease. Data from other populations and animal experiments suggest that neprilysin inhibition (which augments the natriuretic peptide system) may reduce these risks, but clinical trials among patients with CKD are required to test this hypothesis. UK Heart and Renal Protection III (HARP-III) is a multicentre, double-blind, randomized controlled trial comparing sacubitril/valsartan 97/103 mg two times daily (an angiotensin receptor-neprilysin inhibitor) with irbesartan 300 mg one time daily among 414 patients with CKD. Patients ≥18 years of age with an estimated glomerular filtration rate (eGFR) of ≥45 but 20 mg/mmol or eGFR ≥20 but <45 mL/min/1.73 m(2) (regardless of uACR) were invited to be screened. Following a 4- to 7-week pre-randomization single-blind placebo run-in phase (during which any current renin-angiotensin system inhibitors were stopped), willing and eligible participants were randomly assigned either sacubitril/valsartan or irbesartan and followed-up for 12 months. The primary aim was to compare the effects of sacubitril/valsartan and irbesartan on measured GFR after 12 months of therapy. Important secondary outcomes include effects on albuminuria, change in eGFR over time and the safety and tolerability of sacubitril/valsartan in CKD. Between November 2014 and January 2016, 620 patients attended a screening visit and 566 (91%) entered the pre-randomization run-in phase. Of these, 414 (73%) participants were randomized (mean age 63 years; 72% male). The mean eGFR was 34.0 mL/min/1.73 m(2) and the median uACR was 58.5 mg/mmol. UK HARP-III will provide important information on the short-term effects of sacubitril/valsartan on renal function, tolerability and safety among patients with CKD. © The Author 2016. Published by Oxford University Press on behalf of ERA-EDTA.

  19. 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.

  20. Optimizing exposure-based CBT for anxiety disorders via enhanced extinction: Design and methods of a multicentre randomized clinical trial.

    Science.gov (United States)

    Heinig, Ingmar; Pittig, Andre; Richter, Jan; Hummel, Katrin; Alt, Isabel; Dickhöver, Kristina; Gamer, Jennifer; Hollandt, Maike; Koelkebeck, Katja; Maenz, Anne; Tennie, Sophia; Totzeck, Christina; Yang, Yunbo; Arolt, Volker; Deckert, Jürgen; Domschke, Katharina; Fydrich, Thomas; Hamm, Alfons; Hoyer, Jürgen; Kircher, Tilo; Lueken, Ulrike; Margraf, Jürgen; Neudeck, Peter; Pauli, Paul; Rief, Winfried; Schneider, Silvia; Straube, Benjamin; Ströhle, Andreas; Wittchen, Hans-Ulrich

    2017-06-01

    Exposure-based psychological interventions currently represent the empirically best established first line form of cognitive-behavioural therapy for all types of anxiety disorders. Although shown to be highly effective in both randomized clinical and other studies, there are important deficits: (1) the core mechanisms of action are still under debate, (2) it is not known whether such treatments work equally well in all forms of anxiety disorders, including comorbid diagnoses like depression, (3) it is not known whether an intensified treatment with more frequent sessions in a shorter period of time provides better outcome than distributed sessions over longer time intervals. This paper reports the methods and design of a large-scale multicentre randomized clinical trial (RCT) involving up to 700 patients designed to answer these questions. Based on substantial advances in basic research we regard extinction as the putative core candidate model to explain the mechanism of action of exposure-based treatments. The RCT is flanked by four add-on projects that apply experimental neurophysiological and psychophysiological, (epi)genetic and ecological momentary assessment methods to examine extinction and its potential moderators. Beyond the focus on extinction we also involve stakeholders and routine psychotherapists in preparation for more effective dissemination into clinical practice. Copyright © 2017 John Wiley & Sons, Ltd.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-03-15

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

  2. 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.

  3. 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...

  4. Blau syndrome : cross-sectional data from a multicentre study of clinical, radiological and functional outcomes

    NARCIS (Netherlands)

    Rose, Carlos D.; Pans, Steven; Casteels, Ingele; Anton, Jordi; Bader-Meunier, Brigitte; Brissaud, Philippe; Cimaz, Roland; Espada, Graciella; Fernandez-Martin, Jorge; Hachulla, Eric; Harjacek, Miroslav; Khubchandani, Raju; Mackensen, Friederike; Merino, Rosa; Naranjo, Antonio; Oliveira-Knupp, Sheila; Pajot, Christine; Russo, Ricardo; Thomee, Caroline; Vastert, SJ; Wulffraat, Nico; Arostegui, Juan I.; Foley, Kevin P.; Bertin, John; Wouters, Carine H.

    2015-01-01

    Objective. To report baseline articular, functional and ocular findings of the first international prospective cohort study of Blau syndrome (BS). Methods. Three-year, multicentre, observational study on articular, functional (HAQ, Childhood HAQ and VAS global and pain), ophthalmological, therapeuti

  5. [Multicentric reticulohistiocytosis: clinical and ultrastructural study of a case].

    Science.gov (United States)

    Peteiro, C; Fernández-Redondo, V; Zulaica, A; Caeiro, J L; Beiras, A; Toribio, J

    1987-01-01

    A case of multicentric reticulohistiocytosis associated with bilateral Dupuytren's disease and xanthelasmas of the eyelids is described. Ultrastructural examination showed electron-dense intracytoplasmic granules, collagen entrapment and interdigitation of adjacent cytoplasmic membranes.

  6. Early complications of stenting in patients with congenital heart disease : a multicentre study

    NARCIS (Netherlands)

    van Gameren, Menno; Witsenburg, Maarten; Takkenberg, Johanna J. M.; Boshoff, Derize; Mertens, Luc; van Oort, Anton M.; de Wolf, DanieL; Freund, Matthias; Sreeram, Narayanswani; Bokenkamp, Regina; Talsma, Melle D.; Gewillig, Marc

    2006-01-01

    Aims Stenting has become an established interventional cardiology procedure for congenital heart disease. Although most stent procedures are completed successfully, complications may occur. This multicentre study evaluated early complications after stenting in patients with congenital heart disease,

  7. Splinting after contracture release for Dupuytren's contracture (SCoRD: protocol of a pragmatic, multi-centre, randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Chojnowski Adrian J

    2008-04-01

    Full Text Available Abstract Background Splinting as part of the overall post-surgical management of patients after release of Dupuytren's contracture has been widely reported, though there is variation in practice and criteria for using it. The evidence on its effectiveness is sparse, of poor quality and contradictory with studies reporting negative and positive effects. Methods/Design A multi-centre, pragmatic, randomized, controlled trial is being conducted to evaluate the effect of static night splinting for six months on hand function, range of movement, patient satisfaction and recurrence at 1 year after fasciectomy or dermofasciectomy. Using a centrally administered computer randomization system consented patients will be allocated to one of two groups: i splint group who will be given a static splint at approximately 10 to 14 days after surgery to be worn for 6 months at night time only as well as hand therapy; ii non-splint group, who will receive hand therapy only. The primary outcome measure is the patient-reported Disabilities of the Arm, Hand and Shoulder Questionnaire (DASH. Secondary outcomes are total active flexion and extension of fingers, patient satisfaction and recurrence of contracture. Outcome measures will be collected prior to surgery, 3 months, 6 months and 1 year after surgery. Using the DASH as the primary outcome measure, where a difference of 15 points is considered to be a clinically important difference a total of 51 patients will be needed in each group for a power of 90%. An intention-to-treat analysis will be used. Discussion This pragmatic randomized controlled trial will provide much needed evidence on the clinical effectiveness of post-operative night splinting in patients who have undergone fasciectomy or dermofasciectomy for Dupuytren's contracture of the hand. Trial Registration Current Controlled Trials ISRCTN 57079614

  8. A randomized, double-blind, multicentre study comparing daily 2 and 5 mg of tropisetron for the control of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy

    NARCIS (Netherlands)

    Wymenga, ANM; vanderGraaf, WTA; Wils, JA; vanHeukelom, LS; vanderLinden, GHM; DullemondWestland, AC; Nooy, M; vanderHeul, C; deBruijn, KM; deVries, EGE

    1996-01-01

    Background: This study compares efficacy safety and tolerability of 2 and 5 mg tropisetron in prevention of nausea and vomiting induced by low-dose cisplatin- or non-cisplatin-containing chemotherapy. Patients and methods: 152 chemotherapy-naive cancer patients were randomized in a double-blind mann

  9. A cognitive behavioral based group intervention for children with a chronic illness and their parents: a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Schuengel Carlo

    2011-07-01

    Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed

  10. Captopril radionuclide test in renovascular hypertension: a European multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Fommei, E. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Ghione, S. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Hilson, A.J.W. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Mezzasalma, L. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Oei, H.Y. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Piepsz, A. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); Volterrani, D. (Inst. of Clinical Physiology, C.N.R., Multicentre Study Central Office, Pisa (Italy)); European Multicentre Study Group

    1993-07-01

    The efficacy of renal scintigraphy with technetium-99m DTPA before and after captopril was evaluated in a multicentre study. All 380 hypertensive patients in the study underwent renal arteriography; 125 had renal arterial stenosis [>=]70%, and 54 had a technically successful intervention to correct the stenosis. The post-captopril study had a sensitivity of 93% and a specificity of 100% for predicting blood pressure response to intervention, if renal function was normal and a combination of quantitative parameters was applied. In the entire population renal artery stenosis [>=]70% was detected with a sensitivity of 83% and a specificity of 93% if renal function was normal. In patients with abnormal renal function the performance of the test was worse, owing to a lower specificity which could be increased by using only time parameters. The performance of the test was optimal when the post-captopril findings were examined; no improvement was achieved by evaluation of the changes induced by captopril from the baseline. The test can thus be simplified by performing only a post-captopril study for routine use: a negative test would exclude a curable form of renovascular hypertension in right angle 80% and a positive test would predict it in right angle 90% of the patients selected for suspicion of the disease. Usefulness of the scintigraphic test for monitoring the clinical results of intervention is suggested by correlating post-intervention outcome with pre- and post-intervention scintigraphic results. (orig./MG)

  11. Neonatal Procalcitonin Intervention Study (NeoPInS): Effect of Procalcitonin-guided decision making on duration of antibiotic therapy in suspected neonatal early-onset sepsis: A multi-centre randomized superiority and non-inferiority Intervention Study.

    Science.gov (United States)

    Stocker, Martin; Hop, Wim C J; van Rossum, Annemarie M C

    2010-12-08

    Early diagnosis and treatment of the newborn infant with suspected sepsis are essential to prevent severe and life threatening complications. Diagnosis of neonatal sepsis is difficult because of the variable and nonspecific clinical presentation. Therefore, many newborns with nonspecific symptoms are started on antibiotic treatment before the presence of sepsis has been proven. With our recently published single-centre intervention study we were able to show that Procalcitonin determinations allowed to shorten the duration of antibiotic therapy in newborns with suspected early-onset sepsis. The study is designed as randomized controlled international multicenter intervention trial on the efficacy and safety of Procalcitonin guided treatment. Term and near-term infants (gestational age ≥ 34 0/7 weeks) with suspected sepsis in the first 3 days of life requiring empiric antibiotic therapy will be included. The duration of antibiotic therapy in the standard group is based on the attending physician's assessment of the likelihood of infection (infection unlikely, possible, probable or proven). In the Procalcitonin group, if infection is considered to be unlikely or possible, antibiotic therapy is discontinued when two consecutive Procalcitonin values are within the normal range. Co-primary outcome measures are the duration of antibiotic therapy (superiority aspect of the trial) and the proportion of infants with a recurrence of infection requiring additional courses of antibiotic therapy and/or death in the first month of life (safety of study intervention, non-inferiority aspect of the trial). The number of infants to be included equals 800 per arm. With these numbers the power of the study to demonstrate superiority for duration of antibiotic therapy as well as non-inferiority regarding safety, i.e. excluding a disadvantage difference larger than 2% for the experimental arm, will both be greater than 80%. Benefit of the study is a possible limitation of unnecessary

  12. A randomized comparison of balloon angioplasty versus rotational atherectomy in complex coronary lesions (COBRA study)

    National Research Council Canada - National Science Library

    Dill, T; Dietz, U; Hamm, C W; Küchler, R; Rupprecht, H J; Haude, M; Cyran, J; Ozbek, C; Kuck, K H; Berger, J; Erbel, R

    2000-01-01

    .... The Comparison of Balloon-Angioplasty versus Rotational Atherectomy study (COBRA) is a multicentre, prospective, randomized trial to compare short- and long-term effects of percutaneous transluminal coronary angioplasty (PTCA...

  13. 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.

  14. Implementation of the WHO Multicentre Growth Reference Study in Brazil.

    Science.gov (United States)

    Araújo, Cora L; Albernaz, Elaine; Tomasi, Elaine; Victora, Cesar G

    2004-03-01

    The World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) South American site was Pelotas, Brazil. The sample for the longitudinal component was drawn from three hospitals that account for approximately 90% of the city's deliveries. The cross-sectional sample was drawn from a community survey based on households that participated in the longitudinal sample. One of the criteria for site selection was the availability of a large, community based sample of children whose growth was unconstrained by socioeconomic conditions. Local work done in 1993 demonstrated that children of families with incomes at least six times the minimum wage had a stunting rate of 2.5%. Special public relations and implementation activities were designed to promote the acceptance of the study by the community and its successful completion. Among the major challenges of the site were serving as the MGRS pilot site, low baseline breastfeeding initiation and maintenance rates, and reluctance among pediatricians to acknowledge the relevance of current infant feeding recommendations to higher socioeconomic groups.

  15. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial.

    Science.gov (United States)

    Verma, Atul; Mantovan, Roberto; Macle, Laurent; De Martino, Guiseppe; Chen, Jian; Morillo, Carlos A; Novak, Paul; Calzolari, Vittorio; Guerra, Peter G; Nair, Girish; Torrecilla, Esteban G; Khaykin, Yaariv

    2010-06-01

    This multicentre, randomized trial compared three strategies of AF ablation: ablation of complex fractionated electrograms (CFE) alone, pulmonary vein isolation (PVI) alone, and combined PVI + CFE ablation, using standardized automated mapping software. Patients with drug-refractory, high-burden paroxysmal (episodes >6 h, >4 in 6 months) or persistent atrial fibrillation (AF) were enrolled at eight centres. Patients (n = 100) were randomized to one of three arms. For CFE alone (n = 34), spontaneous/induced AF was mapped using validated, automated CFE software and all sites CFE (n = 34), all four PV antra were isolated, followed by AF induction and ablation of all CFE sites until AF termination/non-inducibility. Patients were followed at 3, 6, and 12 months with a visit, ECG, 48 h Holter. Atrial fibrillation symptoms were confirmed by loop recording. Repeat procedures were allowed within the first 6 months. The primary endpoint was freedom from AF >30 s at 1 year. Patients (age 57 +/- 10 years, LA size 42 +/- 6 mm) were 35% persistent AF. In CFE, ablation terminated AF in 68%. Only 0.4 PVs per patient were isolated as a result of CFE. In PVI, 94% had all four PVs successfully isolated. In PVI + CFE, 94% had all four PVs isolated, 76% had inducible AF with additional CFE ablation, with 73% termination of AF. There were significantly more repeat procedures in the CFE arm (47%) vs. PVI (31%) or PVI + CFE (15%) (P = 0.01). After one procedure, PVI + CFE had a significantly higher freedom from AF (74%) compared with PVI (48%) and CFE (29%) (P = 0.004). After two procedures, PVI + CFE still had the highest success (88%) compared with PVI (68%) and CFE (38%) (P = 0.001). Ninety-six percent of these patients were off anti-arrhythmics. Complications were two tamponades, no PV stenosis, and no mortality. In high-burden paroxysmal/persistent AF, PVI + CFE has the highest freedom from AF vs. PVI or CFE alone after one or two procedures. Complex fractionated electrogram alone

  16. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial†

    Science.gov (United States)

    Verma, Atul; Mantovan, Roberto; Macle, Laurent; De Martino, Guiseppe; Chen, Jian; Morillo, Carlos A.; Novak, Paul; Calzolari, Vittorio; Guerra, Peter G.; Nair, Girish; Torrecilla, Esteban G.; Khaykin, Yaariv

    2010-01-01

    Aims This multicentre, randomized trial compared three strategies of AF ablation: ablation of complex fractionated electrograms (CFE) alone, pulmonary vein isolation (PVI) alone, and combined PVI + CFE ablation, using standardized automated mapping software. Methods and results Patients with drug-refractory, high-burden paroxysmal (episodes >6 h, >4 in 6 months) or persistent atrial fibrillation (AF) were enrolled at eight centres. Patients (n = 100) were randomized to one of three arms. For CFE alone (n = 34), spontaneous/induced AF was mapped using validated, automated CFE software and all sites CFE (n = 34), all four PV antra were isolated, followed by AF induction and ablation of all CFE sites until AF termination/non-inducibility. Patients were followed at 3, 6, and 12 months with a visit, ECG, 48 h Holter. Atrial fibrillation symptoms were confirmed by loop recording. Repeat procedures were allowed within the first 6 months. The primary endpoint was freedom from AF >30 s at 1 year. Patients (age 57 ± 10 years, LA size 42 ± 6 mm) were 35% persistent AF. In CFE, ablation terminated AF in 68%. Only 0.4 PVs per patient were isolated as a result of CFE. In PVI, 94% had all four PVs successfully isolated. In PVI + CFE, 94% had all four PVs isolated, 76% had inducible AF with additional CFE ablation, with 73% termination of AF. There were significantly more repeat procedures in the CFE arm (47%) vs. PVI (31%) or PVI + CFE (15%) (P = 0.01). After one procedure, PVI + CFE had a significantly higher freedom from AF (74%) compared with PVI (48%) and CFE (29%) (P = 0.004). After two procedures, PVI + CFE still had the highest success (88%) compared with PVI (68%) and CFE (38%) (P = 0.001). Ninety-six percent of these patients were off anti-arrhythmics. Complications were two tamponades, no PV stenosis, and no mortality. Conclusion In high-burden paroxysmal/persistent AF, PVI + CFE has the highest freedom from AF vs. PVI or CFE alone after one or two procedures. Complex

  17. Indigenous recombinant streptokinase Vs natural streptokinase in acute myocardial infarction patients: Phase III multicentric randomized double blind trial

    Directory of Open Access Journals (Sweden)

    Diwedi S

    2005-05-01

    Full Text Available Background : Streptokinase is the most widely used thrombolytic agent and can now be made using recombinant DNA technology. The present trial was initiated to assess an indigenous recombinant streptokinase (Shankinase, r-SK. Aim: To compare the efficacy and safety of indigenous recombinant streptokinase (Shankinase, r-SK and natural streptokinase (Streptase, n-SK. Settings and Design: Double blind, randomized, non-inferiority, multicentric, parallel study. Materials and Methods: Patients of AMI < 6 hours of chest pain and 2 mm ST elevation in 2 contiguous chest leads V1- V6 or 1 mm in limb leads were randomized to receive 1.5 miu of either r-SK or n-SK. CK Peaking and decrease of > 50% ST segment were used to assess reperfusion. Statistical analysis: Difference in the groups was assessed by chi-square or paired t test as required. Probability value Results: Overall 150 patients were recruited (96 r-SK group and 54 in n-SK group and demographic and clinical profile of the groups was comparable. Reperfusion was seen in 68.2% (58 and 69.4% (34 patients in r-SK and n-SK groups respectively. Commonly seen adverse events were fever in 7 (8.5%, hypotension in 3 (3.6%, nausea in 2 (2.4% patients. Minor bleeding were seen in 4 (4.8% of patients. Conclusion: Indigenous recombinant Streptokinase (r-SK is as efficacious as natural streptokinase (n-SK in establishing reperfusion as assessed by non-invasive parameters with comparable side effect profile..

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

    Science.gov (United States)

    Saake, Marc; Langner, Soenke; Schwenke, Carsten; Weibart, Marina; Jansen, Olav; Hosten, Norbert; Doerfler, Arnd

    2016-03-01

    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. Contrast-enhanced MRI plays a key role in the management of multiple sclerosis. Different gadolinium-based contrast agents are available. Number of visibly enhancing lesions increases over time after contrast injection. Gadobutrol and gadoterate meglumine do not differ in number of visible lesions. Gadobutrol generates higher signal intensity than gadoterate meglumine.

  19. Octatropine methyl bromide and diazepam combination (Valpinax) in patients with irritable bowel syndrome: a multicentre, randomized, placebo-controlled trial.

    Science.gov (United States)

    Pace, F; Maurano, A; Ciacci, C; Savarino, V; Attili, A; Iaquinto, G; Magni, E; Porro, G Bianchi

    2010-03-01

    To investigate the efficacy and tolerability of octatropine methyl bromide plus diazepam (Valpinax) in patients with irritable bowel syndrome (IBS). We conducted a randomized, double-blind, multicentre study in 186 patients aged 18-65 years with IBS diagnosed according to Rome II criteria. Following a 2-week washout period, patients received octatropine plus diazepam 40 mg/2.5 mg twice daily or placebo for 6 weeks. The primary efficacy endpoint was response to a weekly question: "did you have satisfactory relief of your abdominal pain and discomfort during the last week?" Other endpoints included abdominal swelling, abdominal pain and discomfort, symptom severity, and the number of bowel movements. A prespecified subgroup analysis was conducted in patients with an abdominal pain and discomfort score > or = 3. The primary efficacy endpoint showed a tendency towards a statistically significant benefit for octatropine plus diazepam over placebo among patients with a baseline abdominal pain and discomfort score of > or = 3 (3 vs. 0 patients; p = 0.059). Octatropine plus diazepam demonstrated significant improvements from baseline in all parameters assessed, but not compared with placebo. Adverse events were reported in 15.1% of patients receiving octatropine plus diazepam. Patients with IBS and an abdominal pain and discomfort score of > or = 3, who may be considered in the active phase of the disease, may derive some benefits from octatropine plus diazepam. This study highlights that Rome II criteria should be considered with particular care in the design of a clinical trial, since it does not consider disease activity level on admission.

  20. The OptiMUM-study: EMDR therapy in pregnant women with posttraumatic stress disorder after previous childbirth and pregnant women with fear of childbirth: design of a multicentre randomized controlled trial

    Science.gov (United States)

    Baas, M. A. M.; Stramrood, C. A. I.; Dijksman, L. M.; de Jongh, A.; van Pampus, M. G.

    2017-01-01

    ABSTRACT Background: Approximately 3% of women develop posttraumatic stress disorder (PTSD) after giving birth, and 7.5% of pregnant women show a pathological fear of childbirth (FoC). FoC or childbirth-related PTSD during (a subsequent) pregnancy can lead to a request for an elective caesarean section as well as adverse obstetrical and neonatal outcomes. For PTSD in general, and several subtypes of specific phobia, eye movement desensitization and reprocessing (EMDR) therapy has been proven effective, but little is known about the effects of applying EMDR during pregnancy. Objective: To describe the protocol of the OptiMUM-study. The main aim of the study is to determine whether EMDR therapy is an effective and safe treatment for pregnant women with childbirth-related PTSD or FoC. In addition, the cost-effectiveness of this approach will be analysed. Method: The single-blind OptiMUM-study consists of two two-armed randomized controlled trials (RCTs) with overlapping design. In several hospitals and community midwifery practices in Amsterdam, the Netherlands, all eligible pregnant women with a gestational age between eight and 20 weeks will be administered the Wijma delivery expectations questionnaire (WDEQ) to asses FoC. Multiparous women will also receive the PTSD checklist for DSM-5 (PCL-5) to screen for possible PTSD. The clinician administered PTSD scale (CAPS-5) will be used for assessing PTSD according to DSM-5 in women scoring above the PCL-5 cut-off value. Fifty women with childbirth-related PTSD and 120 women with FoC will be randomly allocated to either EMDR therapy carried out by a psychologist or care-as-usual. Women currently undergoing psychological treatment or women younger than 18 years will not be included. Primary outcome measures are severity of childbirth-related PTSD or FoC symptoms. Secondary outcomes are percentage of PTSD diagnoses, percentage caesarean sections, subjective childbirth experience, obstetrical and neonatal complications

  1. A European multicentre and open-label controlled randomized trial to evaluate the efficacy of Sequential treatment with TAcrolimus–Rituximab versus steroids plus cyclophosphamide in patients with primary MEmbranous Nephropathy: the STARMEN study

    Science.gov (United States)

    Rojas-Rivera, Jorge; Fernández-Juárez, Gema; Ortiz, Alberto; Hofstra, Julia; Gesualdo, Loreto; Tesar, Vladimir; Wetzels, Jack; Segarra, Alfons; Egido, Jesus; Praga, Manuel

    2015-01-01

    Background Patients with primary membranous nephropathy (MN) and persistent nephrotic syndrome have a high risk of progression to end-stage renal disease. The Ponticelli protocol (steroids with alkylating agents) is the most effective immunosuppressive therapy for this condition, but it has severe adverse effects. Tacrolimus and rituximab have demonstrated efficacy for remission of nephrotic syndrome in MN with a safer profile. However, the published evidence is largely based on small or short-term observational studies, historical cohorts, comparisons with conservative therapy or clinical trials without appropriate control groups, and there is no head-to-head comparison with the Ponticelli protocol. Methods The STARMEN randomized clinical trial will compare the efficacy of sequential tacrolimus–rituximab therapy with a modified Ponticelli protocol (steroids plus cyclophosphamide). The trial will also evaluate the role of antibodies against the M-type phospholipase A2 receptor (anti-PLA2R) and other antibodies as markers of response to treatment and long-term prognosis. Results The trial has already started with 23 patients having been enrolled as of 1 April 2015, an estimated 21.7% of the estimated sample. PMID:26413273

  2. Patterns and predictors of sitting time over ten years in a large population-based Canadian sample: Findings from the Canadian Multicentre Osteoporosis Study (CaMos)

    OpenAIRE

    Gebel, Klaus; Pont, Sarah; Ding, Ding, W.; Bauman, Adrian E.; Chau, Josephine Y; Berger, Claudie; Prior, Jerilynn C; ,

    2017-01-01

    Our objective was to describe patterns and predictors of sedentary behavior (sitting time) over 10 years among a large Canadian cohort. Data are from the Canadian Multicentre Osteoporosis Study, a prospective study of women and men randomly selected from the general population. Respondents reported socio-demographics, lifestyle behaviors and health outcomes in interviewer-administered questionnaires; weight and height were measured. Baseline data were collected between 1995 and 1997 (n = 9418...

  3. 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

  4. [Occult multicentric breast cancer].

    Science.gov (United States)

    Vtorushin, S V; Zab'ialova, M V; Glushchenko, S A; Perel'muter, V M; Slonimskaia, E M

    2009-01-01

    The study included 92 patients with invasive ductal breast cancer (T2-4N0-2M0-1). In 38 cases, tumor growth was unicentric while histologically identifiable ones as multicentric in 44. Multicentricity mostly occurred in cases of macroscopically-identifiable nodes located in the central segments of the breast. Clinically-identifiable nodes of multicentric tumor growth measured more than 3 cm. Multicentric tumors were mostly grade III, featured lower expression of sex hormone receptors and positive Her2 status.

  5. 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. Overal

  6. 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

  7. Effects of acarbose (Glucobay) in persons with type 1 diabetes : a multicentre study

    NARCIS (Netherlands)

    Sels, J P; Verdonk, H E; Wolffenbuttel, B H

    1998-01-01

    The aim of this multicentre study was to investigate the effect--in everyday life--of long term administration of acarbose on parameters of glycaemic control, daily insulin requirements, lipid parameters and tolerability in ambulant type 1 diabetic subjects insufficiently controlled with diet and in

  8. An international multicentre study on the allergenic activity of air-oxidized R-limonene

    DEFF Research Database (Denmark)

    Bråred Christensson, Johanna; Andersen, Klaus; Bruze, Magnus

    2013-01-01

    Limonene is a common fragrance terpene that, in its pure form, is not allergenic or is a very weak allergen. However, limonene autoxidizes on air exposure, and the oxidation products can cause contact allergy. Oxidized R-limonene has previously been patch tested in multicentre studies, giving 2-3...

  9. 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. Overal

  10. Psychometric Properties of the Manchester Child Attachment Story Task: An Italian Multicentre Study

    Science.gov (United States)

    Barone, Lavinia; Del Giudice, Marco; Fossati, Andrea; Manaresi, Francesca; Perinetti, Barbara Actis; Colle, Livia; Veglia, Fabio

    2009-01-01

    The paper describes a multicentre study of the psychometric properties of the Manchester Child Attachment Story Task in a sample of 230 Italian children aged 4 to 8 years. The task's internal consistency and inter-rater reliability were investigated; in addition, multiple discriminant analysis was used to explore the contribution of individual…

  11. Dislocation of the Elbow: A Retrospective Multicentre Study of 86 Patients

    NARCIS (Netherlands)

    J. de Haan (Jeroen); J.F. Zengerink; D. den Hartog (Dennis); W.E. Tuinebreijer (Wim); J. Buijtenen (Jesse van); N.W.L. Schep (Niels)

    2010-01-01

    textabstractThe objective of this retrospective multicentre cohort study was to prospectively assess the long-term functional outcomes of simple and complex elbow dislocations.We analysed the hospital and outpatient records of 86 patients between 01.03.1999 and 25.02.2009 with an elbow dislocation.

  12. Intravenous autologous bone marrow mononuclear stem cell therapy for ischemic stroke: a multicentric, randomized trial.

    Science.gov (United States)

    Prasad, Kameshwar; Sharma, Alka; Garg, Ajay; Mohanty, Sujata; Bhatnagar, Shinjini; Johri, Sharat; Singh, Kunwar Karni; Nair, Velu; Sarkar, Ravi Shankar; Gorthi, Sankar Prasad; Hassan, Kaukab Maqbool; Prabhakar, Sudesh; Marwaha, Neelam; Khandelwal, Niranjan; Misra, Usha Kant; Kalita, Jayantee; Nityanand, Soniya

    2014-12-01

    Pilot studies have suggested benefit from intravenous administration of bone marrow mononuclear stem cells (BMSCs) in stroke. We explored the efficacy and safety of autologous BMSCs in subacute ischemic stroke. This was a phase II, multicenter, parallel group, randomized trial with blinded outcome assessment that included 120 patients. Patients with subacute ischemic stroke were randomly assigned to the arm that received intravenous infusion of autologous BMSCs or to control arm. Coprimary clinical efficacy outcomes were Barthel Index score and modified Rankin scale at day 180. Secondary outcomes were change in infarct volume, National Institute of Health Stroke Scale (NIHSS) at day 90 and 180. Main safety outcomes were adverse events, any new area of (18)fluorodeoxyglucose positron emission tomography uptake in any body part over 365 days. Fifty-eight patients received a mean of 280.75 million BMSCs at median of 18.5 days after stroke onset. There was no significant difference between BMSCs arm and control arm in the Barthel Index score (63.1 versus 63.6; P=0.92), modified Rankin scale shift analysis (P=0.53) or score >3 (47.5% versus 49.2%; P=0.85), NIHSS score (6.3 versus 7.0; P=0.53), change in infarct volume (-11.1 versus -7.36; P=0.63) at day 180. Adverse events were also similar in the 2 arms, and no patient showed any new area of (18)fluorodeoxyglucose uptake. With the methods used, results of this hitherto first randomized controlled trial indicate that intravenous infusion of BMSCs is safe, but there is no beneficial effect of treatment on stroke outcome. URLs: http://ctri.nic.in/Clinicaltrials and http://www.clinicaltrials.gov. Unique identifiers: CTRI-ROVCTRI/2008/091/0004 and NCT0150177. © 2014 American Heart Association, Inc.

  13. Use of metformin before and during assisted reproductive technology in non-obese young infertile women with polycystic ovary syndrome: a prospective, randomized, double-blind, multi-centre study

    DEFF Research Database (Denmark)

    Kjøtrød, S B; Carlsen, S M; Rasmussen, P E

    2011-01-01

    To study the effect of metformin before and during assisted reproductive technology (ART) on the clinical pregnancy rate (CPR) in non-obese women with polycystic ovary syndrome (PCOS).......To study the effect of metformin before and during assisted reproductive technology (ART) on the clinical pregnancy rate (CPR) in non-obese women with polycystic ovary syndrome (PCOS)....

  14. Randomized, multicentre assessment of the efficacy and safety of ASAQ – a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria

    Directory of Open Access Journals (Sweden)

    Diallo Mouctar

    2009-06-01

    Full Text Available Abstract Background The use of artemisinin derivative-based combination therapy (ACT such as artesunate plus amodiaquine is currently recommended for the treatment of uncomplicated Plasmodium falciparum malaria. Fixed-dose combinations are more adapted to patients than regimens involving multiple tablets and improve treatment compliance. A fixed-dose combination of artesunate + amodiaquine (ASAQ was recently developed. To assess the efficacy and safety of this new combination and to define its optimum dosage regimen (once or twice daily in the treatment of uncomplicated P. falciparum malaria, a multicentre clinical study was conducted. Methods A multicentre, randomized, controlled, investigator-blinded, parallel-group study was conducted in five African centers in Cameroon, Madagascar, Mali and Senegal from March to December 2006. Efficacy and safety of ASAQ were assessed compared to those of artemether + lumefantrine (AL. The WHO protocol with a 28-day follow-up for assessing the drug therapeutic efficacy was used. Patients suffering from uncomplicated P. falciparum malaria were randomized to receive ASAQ orally once daily (ASAQ1, ASAQ twice daily (ASAQ2 or AL twice daily (AL for three days. The primary outcome was PCR-corrected parasitological cure rate and clinical response. Results Of 941 patients initially randomized and stratified into two age groups ( Conclusion The non-inferiority of ASAQ compared with AL was demonstrated. The fixed-dose combination artesunate + amodiaquine (ASAQ is safe and efficacious even in young children under 5 years of age. Whilst administration on a twice-a-day basis does not improve the efficacy of ASAQ significantly, a once-a-day intake of this new combination clearly appears as an effective and safe therapy in the treatment of uncomplicated P. falciparum malaria both in adults and children. Implications of such findings are of primary importance in terms of public health especially in African countries. As

  15. The addition of sirolimus to the graft-versus-host disease prophylaxis regimen in reduced intensity allogeneic stem cell transplantation for lymphoma: a multicentre randomized trial.

    Science.gov (United States)

    Armand, Philippe; Kim, Haesook T; Sainvil, Marie-Michele; Lange, Paulina B; Giardino, Angela A; Bachanova, Veronika; Devine, Steven M; Waller, Edmund K; Jagirdar, Neera; Herrera, Alex F; Cutler, Corey; Ho, Vincent T; Koreth, John; Alyea, Edwin P; McAfee, Steven L; Soiffer, Robert J; Chen, Yi-Bin; Antin, Joseph H

    2016-04-01

    Inhibition of the mechanistic target of rapamycin (mTOR) pathway has clinical activity in lymphoma. The mTOR inhibitor sirolimus has been used in the prevention and treatment of graft-versus-host disease (GVHD) after allogeneic haematopoietic stem cell transplantation (HSCT). A retrospective study suggested that patients with lymphoma undergoing reduced intensity conditioning (RIC) HSCT who received sirolimus as part of their GVHD prophylaxis regimen had a lower rate of relapse. We therefore performed a multicentre randomized trial comparing tacrolimus, sirolimus and methotrexate to standard regimens in adult patients undergoing RIC HSCT for lymphoma in order to assess the possible benefit of sirolimus on HSCT outcome. 139 patients were randomized. There was no difference overall in 2-year overall survival, progression-free survival, relapse, non-relapse mortality or chronic GVHD. However, the sirolimus-containing arm had a significantly lower incidence of grade II-IV acute GVHD (9% vs. 25%, P = 0·015), which was more marked for unrelated donor grafts. In conclusion, the addition of sirolimus for GVHD prophylaxis in RIC HSCT is associated with no increased overall toxicity and a lower risk of acute GVHD, although it does not improve survival; this regimen is an acceptable option for GVHD prevention in RIC HSCT. This trial is registered at clinicaltrials.gov (NCT00928018).

  16. Oral iloprost in Raynaud's phenomenon secondary to systemic sclerosis : A multicentre, placebo-controlled, dose-comparison study

    NARCIS (Netherlands)

    Black, CM; Halkier-Sorensen, L; Belch, JJF; Ullman, S; Madhok, R; Smit, AJ; Banga, JD; Watson, HR

    Objective. To identify the optimal dose of oral iloprost bn the basis of efficacy and tolerability in patients with Raynaud's phenomenon secondary to systemic sclerosis. Design. Multicentre, randomized, parallel-group comparison of two different doses of oral iloprost and placebo. Setting. European

  17. Oral iloprost in Raynaud's phenomenon secondary to systemic sclerosis : A multicentre, placebo-controlled, dose-comparison study

    NARCIS (Netherlands)

    Black, CM; Halkier-Sorensen, L; Belch, JJF; Ullman, S; Madhok, R; Smit, AJ; Banga, JD; Watson, HR

    1998-01-01

    Objective. To identify the optimal dose of oral iloprost bn the basis of efficacy and tolerability in patients with Raynaud's phenomenon secondary to systemic sclerosis. Design. Multicentre, randomized, parallel-group comparison of two different doses of oral iloprost and placebo. Setting. European

  18. A large-scale multicentre cerebral diffusion tensor imaging study in amyotrophic lateral sclerosis

    OpenAIRE

    Muller, Hans-Peter; R Turner, Martin; Grosskreutz, Julian; Abrahams, Sharon; Bede, Peter; Govind, Varan; Prudlo, Johannes; Ludolph, Albert C.; Filippi, Massimo; Kassubek, Jan

    2016-01-01

    Objective: Damage to the cerebral tissue structural connectivity associated with amyotrophic lateral sclerosis (ALS), which extends beyond the motor pathways, can be visualized by diffusion tensor imaging (DTI). The effective translation of DTI metrics as biomarker requires its application across multiple magnetic resonance imaging scanners and patient cohorts. A multi-centre study was undertaken to assess structural connectivity in ALS at a large sample size. Methods: Four-hundred-and-forty-...

  19. A prospective, randomized, multicentre trial for the treatment of refractory status epilepticus; experiences from evaluating the effect of the novel drug candidate, NS1209.

    Science.gov (United States)

    Sabers, Anne; Wolf, Peter; Møller, Arne; Rysgaard, Karen; Ben-Menachem, Elinor

    2013-09-01

    Refractory status epilepticus (RSE) is a life-threatening condition that requires immediate and aggressive treatment. Unfortunately, sometimes standard antiepileptic treatment is insufficient. Furthermore, alternative therapeutic options are limited by low evidence of efficacy. The primary objective of this study was to evaluate the effects of the novel drug candidate, NS1209 versus third-line standard treatment (phenytoin/valproate) for RSE. Having not reached the study end-points, the purpose of this paper is to discuss the challenges that are encountered in conducting a controlled study of RSE. This was a phase II, prospective, multicentre, single-blinded, randomized clinical trial and included patients to two separate protocols for convulsive and non-convulsive RSE (NS1209-006 and NS1209-007). In total, 28 patients were included and 14 patients were exposed to NS1209. At study conclusion, the study was insufficiently powered to detect any statistically significant difference between the two treatment groups. This was especially true for the convulsive RSE protocol. We conclude that high-quality studies in RSE are difficult to conduct owing to a number of ethical and practical problems associated with this critical illness. Challenges for further studies are discussed.

  20. Correcting waveform bias using principal component analysis: Applications in multicentre motion analysis studies.

    Science.gov (United States)

    Clouthier, Allison L; Bohm, Eric R; Rudan, John F; Shay, Barbara L; Rainbow, Michael J; Deluzio, Kevin J

    2017-01-01

    Multicentre studies are rare in three dimensional motion analyses due to challenges associated with combining waveform data from different centres. Principal component analysis (PCA) is a statistical technique that can be used to quantify variability in waveform data and identify group differences. A correction technique based on PCA is proposed that can be used in post processing to remove nuisance variation introduced by the differences between centres. Using this technique, the waveform bias that exists between the two datasets is corrected such that the means agree. No information is lost in the individual datasets, but the overall variability in the combined data is reduced. The correction is demonstrated on gait kinematics with synthesized crosstalk and on gait data from knee arthroplasty patients collected in two centres. The induced crosstalk was successfully removed from the knee joint angle data. In the second example, the removal of the nuisance variation due to the multicentre data collection allowed significant differences in implant type to be identified. This PCA-based technique can be used to correct for differences between waveform datasets in post processing and has the potential to enable multicentre motion analysis studies.

  1. Multicentric fibromyxoid peripheral nerve sheath tumor (multicentric schwannoma) in a dromedary camel (Camelus dromedarius): morphopathological, immunohistochemical, and electron microscopic studies.

    Science.gov (United States)

    Khodakaram-Tafti, A; Khordadmehr, M

    2011-11-01

    During postslaughter inspection of a 4-year-old male dromedary camel (Camelus dromedarius), numerous small nodules to large masses up to 4 cm in diameter were found on the serosal surfaces of forestomachs, large intestines, mesentery, liver, and spleen. Grossly, the masses were discrete, round, smooth, and white to gray that bulged from the serosal layer. Cut surfaces of the masses were discrete, round, white, and relatively homogeneous without any necrotic foci. Histopathologically, the masses were encapsulated and composed of a mixture of round and spindle-shaped cells in loose whorls of neoplastic cells with small elongated hyperchromatic wavy nuclei and a small amount of pale eosinophilic, poorly defined cytoplasm. Masson's trichrome staining showed mild amounts of collagen fibers forming an irregular, loose stroma. In immunohistochemistry, immunoreactivity for the Schwann cell marker (S100) was diffusely positive in the neoplastic cells. The immunoreactivity for CK, c-kit, and CD34 were negative. Ultrastructural examination confirmed the tumor was entirely formed of neoplastic Schwann cells. On the basis of the histopathological, immunohistochemical, and ultrastructural findings, the tumors were diagnosed as multicentric fibromyxoid peripheral nerve sheath tumor (multicentric schwannoma). This tumor has not been previously recorded in camel worldwide.

  2. Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial.

    Science.gov (United States)

    Tembe, D V; Dhavale, A; Desai, H; Mane, D N; Raut, S K; Dhingra, G; Sardesai, U; Saoji, S; Rohra, M; Shinde, V G; Padsalge, M; Paliwal, A; Abbasi, K; Devnani, P; Papinwar, S; Phadke, S; Mehta, H; Bhailume, V

    2011-01-01

    Aim. To compare the efficacy and safety of armodafinil, the R-enantiomer of modafinil, with modafinil in patients of shift work sleep disorder (SWSD). Material and Methods. This was a 12-week, randomized, comparative, double-blind, multicentric, parallel-group study in 211 patients of SWSD, receiving armodafinil (150 mg) or modafinil (200 mg) one hour prior to the night shift. Outcome Measures. Efficacy was assessed by change in stanford sleepiness score (SSS) by at least 2 grades (responder) and global assessment for efficacy. Safety was assessed by incidence of adverse events, change in laboratory parameters, ECG, and global assessment of tolerability. Results. Both modafinil and armodafinil significantly improved sleepiness mean grades as compared to baseline (P armodafinil (72.12%) and modafinil (74.29%) were comparable (P = .76). Adverse event incidences were comparable. Conclusion. Armodafinil was found to be safe and effective in the treatment of SWSD in Indian patients. The study did not demonstrate any difference in efficacy and safety of armodafinil 150 mg and modafinil 200 mg.

  3. Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial

    Directory of Open Access Journals (Sweden)

    D. V. Tembe

    2011-01-01

    Full Text Available Aim. To compare the efficacy and safety of armodafinil, the R-enantiomer of modafinil, with modafinil in patients of shift work sleep disorder (SWSD. Material and Methods. This was a 12-week, randomized, comparative, double-blind, multicentric, parallel-group study in 211 patients of SWSD, receiving armodafinil (150 mg or modafinil (200 mg one hour prior to the night shift. Outcome Measures. Efficacy was assessed by change in stanford sleepiness score (SSS by at least 2 grades (responder and global assessment for efficacy. Safety was assessed by incidence of adverse events, change in laboratory parameters, ECG, and global assessment of tolerability. Results. Both modafinil and armodafinil significantly improved sleepiness mean grades as compared to baseline (<.0001. Responder rates with armodafinil (72.12% and modafinil (74.29% were comparable (=.76. Adverse event incidences were comparable. Conclusion. Armodafinil was found to be safe and effective in the treatment of SWSD in Indian patients. The study did not demonstrate any difference in efficacy and safety of armodafinil 150 mg and modafinil 200 mg.

  4. Obstetric risk indicators for labour dystocia in nulliparous women: a multi-centre cohort study

    DEFF Research Database (Denmark)

    Kjaergaard, H.; Olsen, J.; Ottesen, Bent Smedegaard

    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......: The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix

  5. Using DTI to assess white matter microstructure in cerebral small vessel disease (SVD) in multicentre studies.

    Science.gov (United States)

    Croall, Iain D; Lohner, Valerie; Moynihan, Barry; Khan, Usman; Hassan, Ahamad; O'Brien, John T; Morris, Robin G; Tozer, Daniel J; Cambridge, Victoria C; Harkness, Kirsty; Werring, David J; Blamire, Andrew M; Ford, Gary A; Barrick, Thomas R; Markus, Hugh S

    2017-06-01

    Diffusion tensor imaging (DTI) metrics such as fractional anisotropy (FA) and mean diffusivity (MD) have been proposed as clinical trial markers of cerebral small vessel disease (SVD) due to their associations with outcomes such as cognition. However, studies investigating this have been predominantly single-centre. As clinical trials are likely to be multisite, further studies are required to determine whether associations with cognition of similar strengths can be detected in a multicentre setting. One hundred and nine patients (mean age =68 years) with symptomatic lacunar infarction and confluent white matter hyperintensities (WMH) on MRI was recruited across six sites as part of the PRESERVE DTI substudy. After handling missing data, 3T-MRI scanning was available from five sites on five scanner models (Siemens and Philips), alongside neuropsychological and quality of life (QoL) assessments. FA median and MD peak height were extracted from DTI histogram analysis. Multiple linear regressions were performed, including normalized brain volume, WMH lesion load, and n° lacunes as covariates, to investigate the association of FA and MD with cognition and QoL. DTI metrics from all white matter were significantly associated with global cognition (standardized β =0.268), mental flexibility (β =0.306), verbal fluency (β =0.376), and Montreal Cognitive Assessment (MoCA) (β =0.273). The magnitudes of these associations were comparable with those previously reported from single-centre studies found in a systematic literature review. In this multicentre study, we confirmed associations between DTI parameters and cognition, which were similar in strength to those found in previous single-centre studies. The present study supports the use of DTI metrics as biomarkers of disease progression in multicentre studies. © 2017 The Author(s).

  6. [Acupuncture and moxibustion for peripheral facial palsy at different stages: multi-central large-sample randomized controlled trial].

    Science.gov (United States)

    Li, Ying; Li, Yan; Liu, Li-an; Zhao, Ling; Hu, Ka-ming; Wu, Xi; Chen, Xiao-qin; Li, Gui-ping; Mang, Ling-ling; Qi, Qi-hua

    2011-04-01

    To explore the best intervention time of acupuncture and moxibustion for peripheral facial palsy (Bell's palsy) and the clinical advantage program of selective treatment with acupuncture and moxibustion. Multi-central large-sample randomized controlled trial was carried out. Nine hundreds cases of Bell's palsy were randomized into 5 treatment groups, named selective filiform needle group (group A), selective acupuncture + moxibustion group (group B), selective acupuncture + electroacupuncture (group C), selective acupuncture + line-up needling on muscle region of meridian group (group D) and non-selective filiform needle group (group E). Four sessions of treatment were required in each group. Separately, during the enrollment, after 4 sessions of treatment, in 1 month and 3 months of follow-up after treatment, House-Brackmann Scale, Facial Disability Index Scale and Degree of Facial Nerve Paralysis (NFNP) were adopted for efficacy assessment. And the efficacy systematic analysis was provided in view of the intervention time and nerve localization of disease separately. The curative rates of intervention in acute stage and resting stage were 50.1% (223/445) and 52.1% (162/311), which were superior to recovery stage (25.9%, 35/135) separately. There were no statistical significant differences in efficacy in comparison among 5 treatment programs at the same stage (all P > 0.05). The efficacy of intervention of group A and group E in acute stage was superior to that in recovery stage (both P < 0.01). The difference was significant statistically between the efficacy on the localization above chorda tympani nerve and that on the localization below the nerve in group D (P < 0.01). The efficacy on the localization below chorda tympani nerve was superior to the localization above the nerve. The best intervention time for the treatment of Bell's palsy is in acute stage and resting stage, meaning 1 to 3 weeks after occurrence. All of the 5 treatment programs are advantageous

  7. Comparison between repaglinide and glipizide in Type 2 diabetes mellitus: a 1-year multicentre study

    DEFF Research Database (Denmark)

    Madsbad, Sten; Kilhovd, B; Lager, I

    2001-01-01

    ) 20-35 kg/m2, HbA1c 4.2-12.8%), without signs of severe microvascular or macrovascular complications, were included in this double-blind, multicentre, parallel-group comparative trial. Patients were randomized at a 2:1 ratio to repaglinide, 1-4 mg at mealtimes, or glipizide, 5-15 mg daily. RESULTS......AIMS: To evaluate the long-term effectiveness and safety of repaglinide, a novel prandial glucose regulator, in comparison with glipizide in the treatment of patients with Type 2 diabetes. METHODS: Diet or tablet-treated patients with Type 2 diabetes (n = 256; age 40-75 years, body mass index (BMI...... with Type 2 diabetes, and is better than glipizide in controlling HbA1c and FBG levels, overall, and in OHA-naive patients....

  8. Impairment-oriented training or Bobath therapy for severe arm paresis after stroke: a single-blind, multicentre randomized controlled trial.

    Science.gov (United States)

    Platz, T; Eickhof, C; van Kaick, S; Engel, U; Pinkowski, C; Kalok, S; Pause, M

    2005-10-01

    To study the effects of augmented exercise therapy time for arm rehabilitation as either Bobath therapy or the impairment-oriented training (Arm BASIS training) in stroke patients with arm severe paresis. Single blind, multicentre randomized control trial. Three inpatient neurorehabilitation centres. Sixty-two anterior circulation ischaemic stroke patients. Random assignment to three group: (A) no augmented exercise therapy time, (B) augmented exercise therapy time as Bobath therapy and (C) augmented exercise therapy time as Arm BASIS training. Fugl-Meyer arm motor score. Secondary measure: Action Research Arm Test (ARA). Ancillary measures: Fugl-Meyer arm sensation and joint motion/pain scores and the Ashworth Scale (elbow flexors). An overall effect of augmented exercise therapy time on Fugl-Meyer scores after four weeks was not corroborated (mean and 95% confidence interval (CI) of change scores: no augmented exercise therapy time (n=20) 8.8, 5.2-12.3; augmented exercise therapy time (n=40) 9.9, 6.8-13.9; p = 0.2657). The group who received the augmented exercise therapy time as Arm BASIS training (n=20) had, however, higher gains than the group receiving the augmented exercise therapy time as Bobath therapy (n=20) (mean and 95% CI of change scores: Bobath 7.2, 2.6-11.8; BASIS 12.6, 8.4-16.8; p = 0.0432). Passive joint motion/pain deteriorated less in the group who received BASIS training (mean and 95% CI of change scores: Bobath -3.2, -5.2 to -1.1; BASIS 0.1, -1.8-2.0; p = 0.0090). ARA, Fugl-Meyer arm sensation, and Ashworth Scale scores were not differentially affected. The augmented exercise therapy time as Arm BASIS training enhanced selective motor control. Type of training was more relevant for recovery of motor control than therapeutic time spent.

  9. Neuroimaging Findings in First Unprovoked Seizures: A Multicentric Study in Tehran

    OpenAIRE

    Mohsen MOLLA MOHAMMADI; TONEKABONI, Seyed Hassan; Khatami, Alireza; Azargashb, Eznollah; Tavasoli, Azita; Javadzadeh, Mohsen; Zamani, Gholamreza

    2013-01-01

    How to Cite This Article: Molla Mohammadi M, Tonekaboni SH, Khatami AR, Azargashb E, Tavasoli A, Javadzadeh M, Zamani GR. Neuroimaging Findings in First Unprovoked Seizures: A Multicentric Study in Tehran. Iran J Child Neurol. 2013 Autumn; 7(4):24-31.ObjectiveSeizure is an emergency in pediatrics. It really matters to the parents of the involved child to have information about the causes, management and prognosis.First unprovoked seizures (FUS) are seizures that occur in patients without feve...

  10. Prospective, Controlled, Multicentre Study of Loperimide in Pregnancy

    Directory of Open Access Journals (Sweden)

    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.

  11. Severe Postpartum Hemorrhage from Uterine Atony: A Multicentric Study

    Directory of Open Access Journals (Sweden)

    Carlos Montufar-Rueda

    2013-01-01

    Full Text Available Objective. Postpartum hemorrhage (PPH is an important cause of maternal mortality (MM around the world. Seventy percent of the PPH corresponds to uterine atony. The objective of our study was to evaluate multicenter PPH cases during a 10-month period, and evaluate severe postpartum hemorrhage management. Study Design. The study population is a cohort of vaginal delivery and cesarean section patients with severe postpartum hemorrhage secondary to uterine atony. The study was designed as a descriptive, prospective, longitudinal, and multicenter study, during 10 months in 13 teaching hospitals. Results. Total live births during the study period were 124,019 with 218 patients (0.17% with severe postpartum hemorrhage (SPHH. Total maternal deaths were 8, for mortality rate of 3.6% and a MM rate of 6.45/100,000 live births (LB. Maternal deaths were associated with inadequate transfusion therapy. Conclusions. In all patients with severe hemorrhage and subsequent hypovolemic shock, the most important therapy is intravascular volume resuscitation, to reduce the possibility of target organ damage and death. Similarly, the current proposals of transfusion therapy in severe or massive hemorrhage point to early transfusion of blood products and use of fresh frozen plasma, in addition to packed red blood cells, to prevent maternal deaths.

  12. Severe Postpartum Hemorrhage from Uterine Atony: A Multicentric Study

    Science.gov (United States)

    Montufar-Rueda, Carlos; Rodriguez, Laritza; Jarquin, José Douglas; Barboza, Alejandra; Bustillo, Maura Carolina; Marin, Flor; Ortiz, Guillermo; Estrada, Francisco

    2013-01-01

    Objective. Postpartum hemorrhage (PPH) is an important cause of maternal mortality (MM) around the world. Seventy percent of the PPH corresponds to uterine atony. The objective of our study was to evaluate multicenter PPH cases during a 10-month period, and evaluate severe postpartum hemorrhage management. Study Design. The study population is a cohort of vaginal delivery and cesarean section patients with severe postpartum hemorrhage secondary to uterine atony. The study was designed as a descriptive, prospective, longitudinal, and multicenter study, during 10 months in 13 teaching hospitals. Results. Total live births during the study period were 124,019 with 218 patients (0.17%) with severe postpartum hemorrhage (SPHH). Total maternal deaths were 8, for mortality rate of 3.6% and a MM rate of 6.45/100,000 live births (LB). Maternal deaths were associated with inadequate transfusion therapy. Conclusions. In all patients with severe hemorrhage and subsequent hypovolemic shock, the most important therapy is intravascular volume resuscitation, to reduce the possibility of target organ damage and death. Similarly, the current proposals of transfusion therapy in severe or massive hemorrhage point to early transfusion of blood products and use of fresh frozen plasma, in addition to packed red blood cells, to prevent maternal deaths. PMID:24363935

  13. Harmonization process and reliability assessment of anthropometric measurements in the elderly EXERNET multi-centre study.

    Directory of Open Access Journals (Sweden)

    Alba Gómez-Cabello

    Full Text Available BACKGROUND: The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. PURPOSE: To describe the standardization process and reliability of the anthropometric measurements carried out in the pilot study and during the final workshop, examining both intra- and inter-rater errors for measurements. MATERIALS AND METHODS: A total of 98 elderly from five different regions participated in the intra-rater error assessment, and 10 different seniors living in the city of Toledo (Spain participated in the inter-rater assessment. We examined both intra- and inter-rater errors for heights and circumferences. RESULTS: For height, intra-rater technical errors of measurement (TEMs were smaller than 0.25 cm. For circumferences and knee height, TEMs were smaller than 1 cm, except for waist circumference in the city of Cáceres. Reliability for heights and circumferences was greater than 98% in all cases. Inter-rater TEMs were 0.61 cm for height, 0.75 cm for knee-height and ranged between 2.70 and 3.09 cm for the circumferences measured. Inter-rater reliabilities for anthropometric measurements were always higher than 90%. CONCLUSION: The harmonization process, including the workshop and pilot study, guarantee the quality of the anthropometric measurements in the elderly EXERNET multi-centre study. High reliability and low TEM may be expected when assessing anthropometry in elderly population.

  14. Diversity of Pneumocystis jirovecii Across Europe: A Multicentre Observational Study

    Directory of Open Access Journals (Sweden)

    Alexandre Alanio

    2017-08-01

    Our study showed the wide population diversity across Europe, with evidence of local clusters of patients harbouring a given genotype. These data suggest a specific association between genotype and underlying disease, with evidence of a different natural history of PCP in HIV patients and renal transplant recipients.

  15. European Maxillofacial Trauma (EURMAT) project: a multicentre and prospective study

    NARCIS (Netherlands)

    Boffano, P.; Roccia, F.; Zavattero, E.; Dediol, E.; Uglešić, V.; Kovačič, Ž.; Vesnaver, A.; Konstantinović, V.S.; Petrović, M.; Stephens, M.; Kanzaria, A.; Bhatti, N.; Holmes, S.; Pechalova, P.F.; Bakardjiev, A.G.; Malanchuk, V.A.; Kopchak, A.V.; Galteland, P.; Mjøen, E.; Skjelbred, P.; Koudougou, C.; Mouallem, G.; Corre, P.; Løes, S.; Lekven, N.; Laverick, S.; Gordon, P.; Tamme, T.; Akermann, S.; Karagozoglu, K.H.; Kommers, S.C.; Forouzanfar, T.

    2015-01-01

    The purpose of this study was to analyse the demographics, causes and characteristics of maxillofacial fractures managed at several European departments of oral and maxillofacial surgery over one year. The following data were recorded: gender, age, aetiology, site of facial fractures, facial injury

  16. Familial aggregation of tinnitus: a European multicentre study.

    NARCIS (Netherlands)

    Hendrickx, J.J.; Demeester, K.; Topsakal, V.; Eyken, E. van; Fransen, E.; Maki-Torkko, E.; Hannula, S.; Jensen, M.; Tropitzsch, A.; Bonaconsa, A.; Mazzoli, M.; Espeso, A.; Verbruggen, K.; Huyghe, J.; Huygen, P.L.M.; Kremer, H.; Kunst, S.J.W.; Manninen, M.; Diaz-Lacava, A.N.; Steffens, M.; Parving, A.; Pyykko, I.; Dhooge, I.J.; Stephens, D.; Orzan, E.; Pfister, M.H.; Bille, M.; Sorri, M.; Cremers, C.W.R.J.; Laer, L. van; Camp, G. van; Wienker, T.F.; Heyning, P. van de

    2007-01-01

    INTRODUCTION AND AIM: Tinnitus is a common condition affecting approximately 20% of the older population. There is increasing evidence that changes in the central auditory system following cochlear malfunctioning are responsible for tinnitus. To date, few investigators have studied the influence of

  17. Risk Factors Associated with Outcome in Liver Retransplantation : Multicentric Study

    NARCIS (Netherlands)

    Mattos, Rogerio O.; Linhares, Marcelo M.; Matos, Delcio; Adam, Rene; Bismuth, Henri; Castaing, Denis; Konietzko, Achim; Lerut, Jan; Porte, Robert J.; Neville, Jamieson; Azoulay, Daniel

    2015-01-01

    Background/Aims: To externally validate the predictive mathematical model of survival designed by Linhares et al. (2006). Methodology: This retrospective study was conducted on 217 individuals submitted to liver retransplantation from January 2000 to December 2008 in four European centers. The follo

  18. [Multicentre study of infection incidence in knee prosthesis].

    Science.gov (United States)

    Jaén, F; Sanz-Gallardo, M I; Arrazola, M P; García de Codes, A; de Juanes, A; Resines, C

    2012-01-01

    To determine the incidence of surgical site infection in knee prosthesis surgical procedure for a follow-up period of one year in twelve hospitals in Madrid region. A prospective study was carried out from January to December 2009 using a national surveillance system called Indicadores Clínicos de Mejora Continua de Calidad. Primary and revision knee joint replacements in patients operated on in the previous year were included. Criteria used to define surgical site infection and patient risk index categories were those established by the Centers for Disease Control and Prevention and National Nosocomial Infections Surveillance. The incidence rates were worked out crude and adjusted by hazard ratio. 2,088 knee prosthesis procedures were analyzed. The overall incidence of surgical site infection was 2.1%. Sixty-five percent of the infections were organ/space. Sixty percent of the infections were identified in the early postoperative period. Of all surgical site infections, 41.9% were microbiologically confirmed. Antibiotic prophylaxis was implemented correctly in 63.3% of the cases. The most important cause of inappropriate prophylaxis was an unsuitable duration in 85.7% of the cases. The presurgical preparation was carried out correctly in 50.3% of surgical operations. The incidence of knee arthroplasty infection was twice as high as in the National Healthcare Safety Network and similar to national rates. In this study, the incidence of infection was within the range of infection rates in other published European studies. Surveillance and control strategies of health care for associated infections allow us to assess trends and the impact of preventive measures. Copyright © 2011 SECOT. Published by Elsevier Espana. All rights reserved.

  19. Sleep disorders in menopause: results from an Italian Multicentric Study.

    Science.gov (United States)

    Fabbrini, Monica; AricÃ, Irene; Tramonti, Francesco; Condurso, Rosaria; Carnicelli, Luca; De Rosa, Anna; Di Perri, Caterina; Bonsignore, Maria Rosaria; Zito, Anna; Russo, Giovanna; Pagliarulo, Maria Giovanna; Guarnieri, Biancamaria; Cerroni, Gianluigi; Mennuni, Gianfranco; Della Marca, Giacomo; Bonanni, Enrica; Silvestri, Rosalia

    2015-01-01

    Menopause in the female life cycle is a special period due to important hormonal, physical and psychological changes. Sleep disruption represents a common complaint for midlife and menopausal women, related to primary sleep disorders, including insomnia, sleep disordered breathing, restless legs syndrome (RLS), mood and anxiety disorder, other medical illness, hormonal-related vasomotor symptoms, and aging per se. Aims of our study were to evaluate the prevalence of sleep disorders in a sample of pre and post menopausal women, and to investigate the relationship between sleep and other medical disorders, and life habits. Among workers in the six participant centers, we enrolled 334 women, aged between 40 and 60 years, that completed a questionnaire that included screening on menarche, menstrual cycle, fertility, parity, menopause, life habits, personal medical and sleep history and related treatment, and self-administered scales for sleep quality (PSQI), excessive daytime sleepiness [Epworth Sleepiness Scale (ESS)], mood disorder [Beck Depression Inventory (BDI)], Berlin Questionnaire for sleep disordered breathing (SDB), IRLS diagnostic interview and Rating Scale. Menopausal and perimenopausal women showed an increased prevalence of poor sleep, high risk of SDB, and mood disorder; menopausal women also reported increased RLS severity. Mood disorder had a significant impact on night sleep measures and excessive daytime sleepiness, as well as on RLS severity, and had a greater prevalence in hypertensive women. Sleep disturbances are frequent in menopausal women. Their aetiology is unclear, but probably multifactorial, and many factors contribute to the sleep disruption. Our data suggest the importance of correctly investigate and address sleep problems associated with menopause, through sleep history, and a sleep study could be obtained if clinically warranted. Pharmacological and behavioural treatment strategies should then be aimed at improving sleep and life

  20. The learning environment and medical student burnout: a multicentre study.

    Science.gov (United States)

    Dyrbye, Liselotte N; Thomas, Matthew R; Harper, William; Massie, F Stanford; Power, David V; Eacker, Anne; Szydlo, Daniel W; Novotny, Paul J; Sloan, Jeff A; Shanafelt, Tait D

    2009-03-01

    Little is known about specific personal and professional factors influencing student distress. The authors conducted a comprehensive assessment of how learning environment, clinical rotation factors, workload, demographics and personal life events relate to student burnout. All medical students (n = 3080) at five medical schools were surveyed in the spring of 2006 using a validated instrument to assess burnout. Students were also asked about the aforementioned factors. A total of 1701 medical students (response rate 55%) completed the survey. Learning climate factors were associated with student burnout on univariate analysis (odds ratio [OR] 1.36-2.07; all P personal life event had a lower frequency of burnout (OR 0.70; P personal life events did not have a higher frequency of burnout than students who did not experience a negative personal life event. On multivariate analysis personal characteristics, learning environment and personal life events were all independently related to student burnout. Although a complex array of personal and professional factors influence student well-being, student satisfaction with specific characteristics of the learning environment appears to be a critical factor. Studies determining how to create a learning environment that cultivates student well-being are needed.

  1. A multicentre prospective study of post-traumatic endophthalmitis.

    Science.gov (United States)

    Cornut, Pierre-Loïc; Youssef, El Bichara; Bron, Alain; Thuret, Gilles; Gain, Philippe; Burillon, Carole; Romanet, Jean-Paul; Vandenesch, François; Maurin, Max; Creuzot-Garcher, Catherine; Chiquet, Christophe

    2013-08-01

    Study the clinical and microbiological characteristics and the prognostic factors of post-traumatic endophthalmitis. Seventeen eyes were included between 2004 and 2010, with clinical and microbiological data collected prospectively. Conventional cultures and panbacterial PCR were performed on aqueous and vitreous samples. Clinical signs of endophthalmitis were observed soon after trauma (1.5 ± 2.5 days). Laceration with an intraocular foreign body (IOFB) was noted in 53% of the patients. At admission, all patients had aqueous humour (71%) and/or vitreous (53%) samples. Fifteen patients (88%) underwent a pars plana vitrectomy. Bacteria were identified in 77% of the cases: Staphylococcus epidermidis (n = 5), Streptococcus (n = 4), Bacillus (n = 2), Pseudomonas stuzeri (n = 1), and Streptococcus salivarius and Gemella haemolysans (multibacterial infection, n = 1). Progression toward phthisis was observed in 35% of the cases; 41% of the patients recuperated visual acuity (VA) ≥20/40. A good final visual prognosis (≥20/40) was significantly associated with initial VA better than light perception (0% versus 70%, p = 0.01) and absence of pupillary fibrin membrane (80% versus 20%, p = 0.05). There was no correlation between visual prognosis and age, the type of laceration (corneal or scleral) or presence of an IOFB. We found a statistical trend toward an association between bacterial virulence and poor final VA. This series showed that better final VA outcomes were associated with initial VA better than light perception, S. epidermidis or culture-negative cases and absence of retinal detachment during the clinical course. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

  2. Multicentre validation study of nucleic acids extraction from FFPE tissues.

    Science.gov (United States)

    Bonin, Serena; Hlubek, Falk; Benhattar, Jean; Denkert, Carsten; Dietel, Manfred; Fernandez, Pedro L; Höfler, Gerald; Kothmaier, Hannelore; Kruslin, Bozo; Mazzanti, Chiara Maria; Perren, Aurel; Popper, Helmuth; Scarpa, Aldo; Soares, Paula; Stanta, Giorgio; Groenen, Patricia J T A

    2010-09-01

    In most pathology laboratories worldwide, formalin-fixed paraffin embedded (FFPE) samples are the only tissue specimens available for routine diagnostics. Although commercial kits for diagnostic molecular pathology testing are becoming available, most of the current diagnostic tests are laboratory-based assays. Thus, there is a need for standardized procedures in molecular pathology, starting from the extraction of nucleic acids. To evaluate the current methods for extracting nucleic acids from FFPE tissues, 13 European laboratories, participating to the European FP6 program IMPACTS (www.impactsnetwork.eu), isolated nucleic acids from four diagnostic FFPE tissues using their routine methods, followed by quality assessment. The DNA-extraction protocols ranged from homemade protocols to commercial kits. Except for one homemade protocol, the majority gave comparable results in terms of the quality of the extracted DNA measured by the ability to amplify differently sized control gene fragments by PCR. For array-applications or tests that require an accurately determined DNA-input, we recommend using silica based adsorption columns for DNA recovery. For RNA extractions, the best results were obtained using chromatography column based commercial kits, which resulted in the highest quantity and best assayable RNA. Quality testing using RT-PCR gave successful amplification of 200 bp-250 bp PCR products from most tested tissues. Modifications of the proteinase-K digestion time led to better results, even when commercial kits were applied. The results of the study emphasize the need for quality control of the nucleic acid extracts with standardised methods to prevent false negative results and to allow data comparison among different diagnostic laboratories.

  3. Infectious sacroiliitis: a retrospective, multicentre study of 39 adults

    Directory of Open Access Journals (Sweden)

    Hermet Marion

    2012-11-01

    Full Text Available Abstract Background Non-brucellar and non-tuberculous infectious sacroiliitis (ISI is a rare disease, with misleading clinical signs that delay diagnosis. Most observations are based on isolated case reports or small case series. Our aim was to describe the clinical, bacteriological, and radiological characteristics of ISI, as well as the evolution of these arthritis cases under treatment. Methods This retrospective study included all ISI cases diagnosed between 1995 and 2011 in eight French rheumatology departments. ISI was diagnosed if sacroiliitis was confirmed bacteriologically or, in the absence of pathogenic agents, if clinical, biological, and radiological data was compatible with this diagnosis and evolution was favourable under antibiotic therapy. Results Overall, 39 cases of ISI were identified in adults, comprising 23 women and 16 men, with a mean age at diagnosis of 39.7 ± 18.1 years. The left sacroiliac joint (SI was affected in 59% of cases, with five cases occurring during the post-partum period. Lumbogluteal pain was the most common symptom (36/39. Manipulations of the SI joint were performed in seven patients and were always painful. Mean score for pain using the visual analogue score was 7.3/10 at admission, while 16 patients were febrile at diagnosis. No risk factor was found for 30.7% of patients. A diagnosis of ISI was only suspected in five cases at admission. The mean time to diagnosis was long, being 43.3 ± 69.1 days on average. Mean C-reactive protein was 149.7 ± 115.3 mg/l, and leukocytosis (leukocytes ≥ 10 G/l was uncommon (n = 15 (mean level of leukocytes 10.4 ± 3.5 G/l. Radiographs (n = 33 were abnormal in 20 cases, revealing lesions of SI, while an abdominopelvic computed tomography (CT scan (n = 27 was abnormal in 21 cases, suggesting arthritis of the SI joints in 13 cases (48.1% and a psoas abscess in eight. Bone scans (n = 14 showed hyperfixation of the SI in 13 cases

  4. Safety and immunogenicity of Bio Pox™, a live varicella vaccine (Oka strain) in Indian children: A comparative multicentric, randomized phase II/III clinical trial.

    Science.gov (United States)

    Dubey, Anand Prakash; Faridi, Mohammad Moonis Akbar; Mitra, Monjori; Kaur, Iqbal Rajinder; Dabas, Aashima; Choudhury, Jaydeep; Mukherjee, Mallar; Mishra, Devendra

    2017-09-02

    Varicella or chickenpox is a highly contagious disease with a high secondary attack rate. Almost 30% of Indian adolescents lack protective antibodies against varicella, emphasizing the need of routine varicella immunization. The Oka VZV is a well-established, safe and efficacious vaccine strain that is highly immunogenic and produces lifelong protective immunity. The present multicentric, open label, randomized, controlled Phase II/III study, compared the Bio Pox™ (indigenous investigational vaccine) with a licensed vaccine, Varivax™ ([a])([a]) Please note that this article refers to the product named VARIVAX as manufactured by Changchun Keygen Biological Products Ltd., China and marketed in India by VHB Life Sciences Limited, Mumbai, and not the product VARIVAX® owned by Merck Sharp & Dohme Corp., Rahway, New Jersey, USA. Merck Sharp & Dohme Corp. have asked us to make clear that the product manufactured by Changchun Keygen Biological Products Ltd. is unrelated to and is not sponsored, endorsed or otherwise authorised by Merck Sharp & Dohme Corp. , for its safety and immunogenicity profile in 252 healthy subjects in the age group of 1-12 y (cohort I: 6-12 years, II:1-6 years) in 3 tertiary medical institutions. Antibodies were measured by VZV Glycoprotein Enzyme Linked Immunoassay (IgG ELISA) kit. Seroconversion percentage in children having pre-vaccination anti VZV IgG titer <10 mIU/mL (< 5 gp ELISA units/mL) were 80% for Bio Pox™ and 77% for Varivax™ (p = 0.692). The seroconversion rate in the group receiving Bio Pox™ was non-inferior to the group that received Varivax™. There were mild local reactions for both the vaccines; none of the patient had fever or required hospitalization or medication. The Bio Pox™ was found to be safe and immunogenic in children against VZV infection.

  5. Prophylactic efficacy of lithium administered every second day: a WHO multicentre study

    DEFF Research Database (Denmark)

    Plenge, P; Amin, M; Agarwal, A K

    1999-01-01

    OBJECTIVES: To study the prophylactic efficacy of lithium administered every second day to patients with bipolar disorder or recurrent unipolar depressive disorder. METHODS: The study was carried out as a WHO multicentre study in five different psychiatric clinics: Russia (Moscow), Canada (Montreal...... of bipolar disorder and five with a diagnosis of recurrent unipolar depressive disorder, participated in the study. The number of patients from each centre ranged from six to 11. The mean lithium dose every second day was 36 mmol lithium, leading to a mean 12-h standard serum lithium concentration during......), India (Lucknow), Germany (Munich) and South Korea (Pusan), with the lithium tablets being supplied from Denmark (Copenhagen). Participation in the study was conditional on the patient having been in prophylactic lithium treatment for the preceding 2-year period and having been free of depressive...

  6. A human post-mortem brain model for the standardization of multi-centre MRI studies.

    Science.gov (United States)

    Droby, Amgad; Lukas, Carsten; Schänzer, Anne; Spiwoks-Becker, Isabella; Giorgio, Antonio; Gold, Ralf; De Stefano, Nicola; Kugel, Harald; Deppe, Michael; Wiendl, Heinz; Meuth, Sven G; Acker, Till; Zipp, Frauke; Deichmann, Ralf

    2015-04-15

    Multi-centre MRI studies of the brain are essential for enrolling large and diverse patient cohorts, as required for the investigation of heterogeneous neurological and psychiatric diseases. However, the multi-site comparison of standard MRI data sets that are weighted with respect to tissue parameters such as the relaxation times (T1, T2) and proton density (PD) may be problematic, as signal intensities and image contrasts depend on site-specific details such as the sequences used, imaging parameters, and sensitivity profiles of the radiofrequency (RF) coils. Water or gel phantoms are frequently used for long-term and/or inter-site quality assessment. However, these phantoms hardly mimic the structure, shape, size or tissue distribution of the human brain. The goals of this study were: (1) to validate the long-term stability of a human post-mortem brain phantom, performing quantitative mapping of T1, T2, and PD, and the magnetization transfer ratio (MTR) over a period of 18months; (2) to acquire and analyse data for this phantom and the brain of a healthy control (HC) in a multi-centre study for MRI protocol standardization in four centres, while conducting a voxel-wise as well as whole brain grey (GM) and white matter (WM) tissue volume comparison. MTR, T2, and the quotient of PD in WM and GM were stable in the post-mortem brain with no significant changes. T1 was found to decrease from 267/236ms (GM/WM) to 234/216ms between 5 and 17weeks post embedment, stabilizing during an 18-month period following the first scan at about 215/190ms. The volumetric measures, based on T1-weighted MP-RAGE images obtained at all participating centres, revealed inter- and intra-centre variations in the evaluated GM and WM volumes that displayed similar trends in both the post-mortem brain as well as the HC. At a confidence level of 95%, brain regions such as the brainstem, deep GM structures as well as boundaries between GM and WM tissues were found to be less reproducible than

  7. Retrospective exposure assessment and quality control in an international multi-centre case-control study

    DEFF Research Database (Denmark)

    Tinnerberg, H; Heikkilä, P; Huici-Montagud, A;

    2003-01-01

    The paper presents the exposure assessment method and quality control procedure used in an international, multi-centre case-control study within a joint Nordic and Italian cohort. This study was conducted to evaluate whether occupational exposure to carcinogens influenced the predictivity of high...... frequency of chromosomal aberrations (CA) in peripheral lymphocytes for increased cancer risk. Occupational hygienists assessed exposures in each participating country: Denmark, Finland, Italy, Norway and Sweden. The exposure status to a carcinogen or a clastogen was coded in the cohort according...... country-specific differences, differences in information available to the home assessor and the others and misunderstandings or difficulties in translation of information. To ensure the consistency of exposure assessments in international retrospective case-control studies it is important to have a well...

  8. Attachment Styles of Dermatological Patients in Europe: A Multi-centre Study in 13 Countries.

    Science.gov (United States)

    Szabó, Csanád; Altmayer, Anita; Lien, Lars; Poot, Françoise; Gieler, Uwe; Tomas-Aragones, Lucía; Kupfer, Jörg; Jemec, Gregor B E; Misery, Laurent; Linder, M Dennis; Sampogna, Francesca; Middendorp, Henriët van; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek C; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Dalgard, Florence

    2017-01-25

    Attachment styles of dermatological outpatients and satisfaction with their dermatologists were investigated within the framework of a multicentre study conducted in 13 European countries, organized by the European Society for Dermatology and Psychiatry. Attachment style was assessed with the Adult Attachment Scale. Patient satisfaction with the dermatologist was assessed with an 11-degree scale. A total of 3,635 adult outpatients and 1,359 controls participated in the study. Dermatological outpatients were less able to depend on others, were less comfortable with closeness and intimacy, and experienced similar rates of anxiety in relationships as did the controls. Participants who had secure attachment styles reported stressful life events during the last 6 months significantly less often than those who had insecure attachment styles. Patients with secure attachment styles tended to be more satisfied with their dermatologist than did insecure patients. These results suggest that secure attachment of dermatological outpatients may be a protective factor in the management of stress.

  9. Early use of non-invasive positive pressure ventilation for acute exacerbations of chronic obstructive pulmonary disease: a multicentre randomized controlled trial

    Institute of Scientific and Technical Information of China (English)

    Collaborative Research Group of Noninvasive Mechan

    2005-01-01

    Background Respiratory muscle fatigue plays an important role in acute exacerbations of chronic obstructive pulmonary disease (AECOPD). In previous clinical studies, non-invasive positive pressure ventilation (NPPV) was proved to be successful only for AECOPD patients with severe respiratory failure. We hypothesized that, the outcomes of AECOPD would be improved if NPPV is early (within 24 to 48 hours of admission) administered in those patients with respiratory muscle fatigue and mild respiratory insufficiency, especially in patients without fulfilling the conventional criteria of mechanical ventilatory support. Methods A prospective multicentre randomized controlled trial was conducted in 19 hospitals in China over 16 months. Three hundred and forty-two AECOPD patients with pH≥7.25 and PaCO2>45 mmHg were recruited on general ward and randomly assigned to standard medical treatment (control group) or early administration of additional NPPV (NPPV group).Results The characteristics of two groups on admission were similar. The number of AECOPD patients requiring intubations in NPPV group was much fewer than that of the control group (8/171 vs 26/71, P=0.002). Subgroup analysis showed the needs for intubation in mildly (pH≥7.35) and severe (pH<7.30) acidotic patients in NPPV group were both decreased (9/80 vs 2/71, P=0.047 and 8/30 vs 3/43, P=0.048, respectively). The mortality in hospital was reduced slightly by NPPV but with no significant difference (7/171 vs 12/171, P=0.345). Respiratory rate (RR),scale for accessory muscle use and arterial pH improved rapidly at the first 2 hours only in patients of NPPV group. After 24 hours, the differences of pH, PaO2, scale for accessory muscle use and RR in NPPV group [(7.36±0.06) mmHg, (72±22) mmHg, (2.5±0.9)/min, (22±4)/min] were statistically significant compared with control group (7.37±0.05) mmHg, (85±34) mmHg, (2.3±1.1)/min, (21±4)/min, P<0.01 for all comparisons].Conclusions The early use of NPPV on

  10. 度洛西汀与帕罗西汀治疗抑郁症的多中心双盲对照研究%Duloxetine versus paroxetine in the treatment of major depressive disorder: a randomized double-blind multicentre controlled study

    Institute of Scientific and Technical Information of China (English)

    原岩波; 张鸿燕; 黄薛冰; 舒良; 李华芳; 王传跃; 吴文源; 赵靖平; 李鸣; 许秀峰

    2011-01-01

    Objective: To evaluate the efficacy and safety of duloxetine in comparison with paroxetine in patients who met Diagnostic and Statistical Manual fourth edition (DSM-IV) criteria of major depressive disorder.Methods: A randomized, double-blind, controlled multicentre clinical trial was conducted.All subjects (n = 244) were treated with either duloxetine 60 mg·d -1 ( n = 121 ) or paroxetine 20 mg·d -1 ( n = 123 ) for 8 weeks.The main efficacy measure was the change in total score of the Hamilton Depression Scale 17 item (HAMD17) from baseline to endpoint.Results: The response rates were 71.1% (duloxetine) and 71.5% (paroxetine).There were no significant differences between 2 groups.The efficacy of duloxetine was non-inferiority of paroxetine's in treatment of MDD.There were significantly higher adverse events in the duloxetine group (75.0%) than in the paroxetine group (62.3% , P = 0.038 1 ).Conclusion: Duloxetine and paroxetine have similar therapeutic effect in treatment of patients with major depressive disorder, but duloxetine causes more adverse events.%目的:以帕罗西汀为对照,评价度洛西汀治疗抑郁症的疗效和安全性.方法:采用随机双盲多中心对照研究方法,244例患者纳入研究,度洛西汀组121例(60 mg·d-1),帕罗西汀组123例(20 mg·d-1),疗程8周.以汉密尔顿抑郁评定量表17项作为主要疗效评价指标.结果:度洛西汀组与帕罗西汀组的有效率分别为71.1%和71.5%(P>0.05).度洛西汀的不良事件发生率(75.0%)高于帕罗西汀组(62.3%),差异有统计学意义(P=0.0381).结论:度洛西汀治疗抑郁症的疗效与帕罗西汀相当,个别不良事件发生率度洛西汀高于帕罗西汀.

  11. Comparison between repaglinide and glipizide in Type 2 diabetes mellitus: a 1-year multicentre study

    DEFF Research Database (Denmark)

    Madsbad, Sten; Kilhovd, B; Lager, I

    2001-01-01

    AIMS: To evaluate the long-term effectiveness and safety of repaglinide, a novel prandial glucose regulator, in comparison with glipizide in the treatment of patients with Type 2 diabetes. METHODS: Diet or tablet-treated patients with Type 2 diabetes (n = 256; age 40-75 years, body mass index (BMI......) 20-35 kg/m2, HbA1c 4.2-12.8%), without signs of severe microvascular or macrovascular complications, were included in this double-blind, multicentre, parallel-group comparative trial. Patients were randomized at a 2:1 ratio to repaglinide, 1-4 mg at mealtimes, or glipizide, 5-15 mg daily. RESULTS......: Changes in fasting blood glucose (FBG) and HbA1c during the 12 months of treatment showed a significant difference in favour of repaglinide. In oral hypoglycaemic agents (OHA)-naive patients, HbA1c decreased in the repaglinide and glipizide groups by 1.5% and 0.3%, respectively (P

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

    Directory of Open Access Journals (Sweden)

    Timothy H Rainer

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

  13. Breast density as indicator for the use of mammography or MRI to screen women with familial risk for breast cancer (FaMRIsc: a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Saadatmand Sepideh

    2012-10-01

    Full Text Available Abstract Background To reduce mortality, women with a family history of breast cancer often start mammography screening at a younger age than the general population. Breast density is high in over 50% of women younger than 50 years. With high breast density, breast cancer incidence increases, but sensitivity of mammography decreases. Therefore, mammography might not be the optimal method for breast cancer screening in young women. Adding MRI increases sensitivity, but also the risk of false-positive results. The limitation of all previous MRI screening studies is that they do not contain a comparison group; all participants received both MRI and mammography. Therefore, we cannot empirically assess in which stage tumours would have been detected by either test. The aim of the Familial MRI Screening Study (FaMRIsc is to compare the efficacy of MRI screening to mammography for women with a familial risk. Furthermore, we will assess the influence of breast density. Methods/Design This Dutch multicentre, randomized controlled trial, with balanced randomisation (1:1 has a parallel grouped design. Women with a cumulative lifetime risk for breast cancer due to their family history of ≥20%, aged 30–55 years are eligible. Identified BRCA1/2 mutation carriers or women with 50% risk of carrying a mutation are excluded. Group 1 receives yearly mammography and clinical breast examination (n = 1000, and group 2 yearly MRI and clinical breast examination, and mammography biennially (n = 1000. Primary endpoints are the number and stage of the detected breast cancers in each arm. Secondary endpoints are the number of false-positive results in both screening arms. Furthermore, sensitivity and positive predictive value of both screening strategies will be assessed. Cost-effectiveness of both strategies will be assessed. Analyses will also be performed with mammographic density as stratification factor. Discussion Personalized breast cancer screening

  14. Alcohol and Tobacco Use Among Undergraduate and Postgraduate Medical Students in India: A Multicentric Cross-sectional Study

    Directory of Open Access Journals (Sweden)

    Nidhi Goel

    2015-02-01

    Full Text Available Background: Substance use among medical fraternity is a well-known phenomenon among both undergraduate (UG and postgraduate (PG medical students. Yet, there have been very few multi-centric studies to estimate the actual burden of this problem in this important population group in India. This study was conducted to estimate the prevalence of alcohol and tobacco use, assess the knowledge and attitudes towards this issue, and identify factors associated with substance use among UG and PG medical students in India.Methods: A pre-tested, self-report, anonymous questionnaire was administered to medical undergraduates and post graduate medical residents of eight medical colleges across India. This study used a convenience sample of medical colleges with random selection of study participants within each college for each group, UG and PG.Results: Prevalence of alcohol and tobacco use among UG students was 16.6%, 95% CI [14.5, 18.9] and 8.0%, 95% CI [6.4, 9.6], respectively, whereas prevalence was 31.5%, 95% CI [26.3, 37.0] and 14.5%, 95% CI [10.7, 18.9], respectively for PGs. For both substances, males had a higher prevalence of use compared to females in both groups (p < 0.001. Positive family history of substance use (p < 0.001 for both groups and early age of initiation (p = 0.011 for tobacco; p > 0.05 for alcohol were associated with a greater difficulty to quit the habit. Over 90% of study participants felt that substance use adversely affected their skills and reported not using substances prior to managing their patients.Conclusions: Since substance use is a relatively common phenomenon among UG and PG medical students in India, future prospective studies and interventions are required to better understand the pattern of substance use and reduce its prevalence. 

  15. Home telemonitoring study for Japanese patients with heart failure (HOMES-HF): protocol for a multicentre randomised controlled trial.

    Science.gov (United States)

    Kotooka, Norihiko; Asaka, Machiko; Sato, Yasunori; Kinugasa, Yoshiharu; Nochioka, Kotaro; Mizuno, Atsushi; Nagatomo, Daisuke; Mine, Daigo; Yamada, Yoko; Eguchi, Kazuo; Hanaoka, Hideki; Inomata, Takayuki; Fukumoto, Yoshihiro; Yamamoto, Kazuhiro; Tsutsui, Hiroyuki; Masuyama, Tohru; Kitakaze, Masafumi; Inoue, Teruo; Shimokawa, Hiroaki; Momomura, Shin-Ichi; Seino, Yoshihiko; Node, Koichi

    2013-06-20

    Despite the encouraging results from several randomised controlled trials (RCTs) and meta-analyses, the ability of home telemonitoring for heart failure (HF) to improve patient outcomes remains controversial as a consequence of the two recent large-scale RCTs. However, it has been suggested that there is a subgroup of patients with HF who may benefit from telemonitoring. The aim of the present study was to investigate whether an HF management programme using telemonitoring could improve outcomes in patients with HF under the Japanese healthcare system. The Home Telemonitoring Study for Japanese Patients with Heart Failure (HOMES-HF) study is a prospective, multicentre RCT to investigate the effectiveness of home telemonitoring on the primary composite endpoint of all-cause death and rehospitalisation due to worsening HF in recently admitted HF patients (aged 20 and older, New York Heart Association classes II-III). The telemonitoring system is an automated physiological monitoring system including body weight, blood pressure and pulse rate by full-time nurses 7 days a week. Additionally, the system was designed to make it a high priority to support patient's self-care instead of an early detection of HF decompensation. A total sample size of 420 patients is planned according to the Schoenfeld and Richter method. Eligible patients are randomly assigned via a website to either the telemonitoring group or the usual care group by using a minimisation method with biased-coin assignment balancing on age, left ventricular ejection fraction and a history of ischaemic heart disease. Participants will be enrolled until August 2013 and followed until August 2014. Time to events will be estimated using the Kaplan-Meier method, and HRs and 95% CIs will be calculated using the Cox proportional hazards models with stratification factors. The study is registered at UMIN Clinical Trials Registry (UMIN000006839).

  16. Antidepressant use and 10-year incident fracture risk: the population-based Canadian Multicentre Osteoporosis Study (CaMoS)

    Science.gov (United States)

    Bernatsky, S.; Abrahamowicz, M.; Papaioannou, A.; Bessette, L.; Adachi, J.; Goltzman, D.; Prior, J.; Kreiger, N.; Towheed, T.; Leslie, W. D.; Kaiser, S.; Ioannidis, G.; Pickard, L.; Fraser, L.-A.; Rahme, E.

    2016-01-01

    Summary We used data from a large, prospective Canadian cohort to assess the association between selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) and fracture. We found an increased risk of fractures in individuals who used SSRI or SNRI, even after controlling for multiple risk factors. Introduction Previous studies have suggested an association between SSRIs and increasing risk of fragility fractures. However, the majority of these studies were not long-term analyses or were performed using administrative data and, thus, could not fully control for potential confounders. We sought to determine whether the use of SSRIs and SNRIs is associated with increased risk of fragility fracture, in adults aged 50+. Methods We used data from the Canadian Multicentre Osteoporosis Study (CaMos), a prospective randomly selected population-based community cohort; our analyses focused on subjects aged 50+. Time to event methodology was used to assess the association between SSRI/SNRI use, modeled time-dependently, and fragility fracture. Results Among 6,645 subjects, 192 (2.9 %) were using SSRIs or/and SNRIs at baseline. During the 10-year study period, 978 (14.7 %) participants experienced at least one fragility fracture. In our main analysis, SSRI/SNRI use was associated with increased risk of fragility fracture (hazard ratio (HR), 1.88; 95 % confidence intervals (CI), 1.48–2.39). After controlling for multiple risk factors, including Charlson score, previous falls, and bone mineral density hip and lumbar bone density, the adjusted HR for current SSRI/SNRI use remained elevated (HR, 1.68; 95 % CI, 1.32–2.14). Conclusions Our results lend additional support to an association between SSRI/SNRI use and fragility fractures. Given the high prevalence of antidepressants use, and the impact of fractures on health, our findings may have a significant clinical impact. PMID:24566587

  17. Myomectomy at the Time of Cesarean Section: A Prospective Multicentre Study

    Directory of Open Access Journals (Sweden)

    Nargis Akhter

    2011-09-01

    Full Text Available Objectives: To assess the safety and efficacy of myomectomy during cesarean section. Methods : The study design was a prospective multicentre study done in three tertiary care hospitals in Dhaka city. The subject were 30 pregnant women underwent elective or emergency myomectomy during cesarean section. All cesarean section myomectomy were performed by consultant. Intra-operative and post-operative complications such as change in haematocrit, length of operation, blood loss were estimated. Length of hospital stay was also recorded. Results : 50 Fibroid of various sizes (2-6cm were removed from 30 women. Fibroid were on the anterior uterine wall with most being subserous and intramural. Four patients had one unit of whole blood transfusion in post-operative period. No hysterectomy was done at the time of cesarean section. There was no significant frequency of blood transfusion; incidence of post- operative fever and duration of operation. The mean duration of post operative hospital study was 7.3±1.2 days. Two patients subsequently became pregnant, were also underwent repeated cesarean section in the study period. Conclusion : In selected cases myomectomy during cesarean section does not appear to result in an increased risk of intrapartum or short-term postpartum morbidity if performed by an experienced practitioner. Cesarean myomectomy is a safe surgical options with no significant complications. Keywords : Cesarean section; myomectomy; uterine myoma. DOI: http://dx.doi.org/10.3329/bsmmuj.v4i2.8639 BSMMU J 2011; 4(2:102-105

  18. Efficacy and safety of tolterodine in subjects with symptoms of overactive bladder: An open label, noncomparative, prospective, multicentric study

    OpenAIRE

    Anant Kumar

    2002-01-01

    Objective: To evaluate the clinical efficacy and safety of Tolterodine 2 mg twice daily in Indian subjects with symptoms of overactive bladder including frequency, ur-gency with or without urge incontinence. Methods: This multicentric open-label, noncompara-tive, prospective study was conducted at 7 centers across India. Eligible patients were assigned to treatment with Tab. Tolterodine 2 mg twice daily for 8 weeks. Subjects were seen at visit ](day 3 to 10), visit 2 (day 1) and after 8...

  19. Efficacy and safety of drotaverine hydrochloride in irritable bowel syndrome: A randomized double-blind placebo-controlled study

    OpenAIRE

    Ramesh R Rai; Manisha Dwivedi; Nirmal Kumar

    2014-01-01

    Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl) 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS). Patients and Methods: The study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of 180 patients with IBS were randomized to drotaverine and placebo tre...

  20. Therapy of uncomplicated falciparum malaria in Europe: MALTHER – a prospective observational multicentre study

    Directory of Open Access Journals (Sweden)

    Bouchaud Olivier

    2012-06-01

    Full Text Available Abstract Background Malaria continues to be amongst the most frequent infectious diseases imported to Europe. Whilst European treatment guidelines are based on data from studies carried out in endemic areas, there is a paucity of original prospective treatment data. The objective was to summarize data on treatments to harmonize and optimize treatment for uncomplicated malaria in Europe. Methods A prospective observational multicentre study was conducted, assessing tolerance and efficacy of treatment regimens for imported uncomplicated falciparum malaria in adults amongst European centres of tropical and travel medicine. Results Between December 2003 and 2009, 504 patients were included in 16 centres from five European countries. Eighteen treatment regimens were reported, the top three being atovaquone-proguanil, mefloquine, and artemether-lumefantrine. Treatments significantly differed with respect to the occurrence of treatment changes (p = 0.005 and adverse events (p = 0.001, parasite and fever clearance times (p  Conclusions This study highlights the heterogeneity of standards of care within Europe. A consensus discussion at European level is desirable to foster a standardized management of imported falciparum malaria.

  1. Creating probabilistic maps of the face network in the adolescent brain: a multicentre functional MRI study.

    Science.gov (United States)

    Tahmasebi, Amir M; Artiges, Eric; Banaschewski, Tobias; Barker, Gareth J; Bruehl, Ruediger; Büchel, Christian; Conrod, Patricia J; Flor, Herta; Garavan, Hugh; Gallinat, Jürgen; Heinz, Andreas; Ittermann, Bernd; Loth, Eva; Mareckova, Klara; Martinot, Jean-Luc; Poline, Jean-Baptiste; Rietschel, Marcella; Smolka, Michael N; Ströhle, Andreas; Schumann, Gunter; Paus, Tomáš

    2012-04-01

    Large-scale magnetic resonance (MR) studies of the human brain offer unique opportunities for identifying genetic and environmental factors shaping the human brain. Here, we describe a dataset collected in the context of a multi-centre study of the adolescent brain, namely the IMAGEN Study. We focus on one of the functional paradigms included in the project to probe the brain network underlying processing of ambiguous and angry faces. Using functional MR (fMRI) data collected in 1,110 adolescents, we constructed probabilistic maps of the neural network engaged consistently while viewing the ambiguous or angry faces; 21 brain regions responding to faces with high probability were identified. We were also able to address several methodological issues, including the minimal sample size yielding a stable location of a test region, namely the fusiform face area (FFA), as well as the effect of acquisition site (eight sites) and scanner (four manufacturers) on the location and magnitude of the fMRI response to faces in the FFA. Finally, we provided a comparison between male and female adolescents in terms of the effect sizes of sex differences in brain response to the ambiguous and angry faces in the 21 regions of interest. Overall, we found a stronger neural response to the ambiguous faces in several cortical regions, including the fusiform face area, in female (vs. male) adolescents, and a slightly stronger response to the angry faces in the amygdala of male (vs. female) adolescents. Copyright © 2011 Wiley Periodicals, Inc.

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

    Directory of Open Access Journals (Sweden)

    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.

  3. A multicentre study on LMW-heparin effectiveness in preventing postsurgical thrombosis.

    Science.gov (United States)

    Verardi, S; Casciani, C U; Nicora, E; Forzano, F; Origone, A; Valle, I; Catania, G; Salanitri, G; Salcuni, P; Azzarone, M

    1988-01-01

    A multicentric study was carried out involving six italian departments of general surgery to assess the efficacy of a low molecular weight (LMW) heparin called Fluxum compared to standard calcium heparin in low doses for prevention of postoperative thromboembolic complications (deep vein thrombosis and pulmonary embolism). 610 patients were treated; 308 (50.5%) of whom were treated with Fluxum at doses of 4,000 or 8,000 I.U. Axa once a day by subcutaneous injection and 302 (49.5%) with heparin calcium at doses of 5,000 I.U. two or three times a day by subcutaneous injection. We observed a total of 29 deep vein thrombosis (4.7%); 10 (3.2%) from the group treated with LMW heparin and 19 (6.3%) from the comparative group. During the study 4 (0.65%) pulmonary embolism were found, 1 (0.32%) in the group treated with LMW heparin and 3 (1%) in the group treated with calcium heparin. None serious hemorrhagic accident was reported during the study. The antithrombotic prophy laxis carried out with Fluxum was on the whole better tolerated than the treatment of the other group, registering a lower frequency of hematomas at the injection and surgical wound sites.

  4. Apolipoprotein E and alpha brain rhythms in mild cognitive impairment: a multicentric electroencephalogram study.

    Science.gov (United States)

    Babiloni, Claudio; Benussi, Luisa; Binetti, Giuliano; Cassetta, Emanuele; Dal Forno, Gloria; Del Percio, Claudio; Ferreri, Florinda; Ferri, Raffaele; Frisoni, Giovanni; Ghidoni, Roberta; Miniussi, Carlo; Rodriguez, Guido; Romani, Gian Luca; Squitti, Rosanna; Ventriglia, Maria Carla; Rossini, Paolo M

    2006-02-01

    Relationships between the apolipoprotein E epsilon4 allele and electroencephalographic (EEG) rhythmicity have been demonstrated in Alzheimer's disease (AD) patients but not in the preclinical stage prodromic to it, namely, mild cognitive impairment (MCI). The present multicentric EEG study tested the hypothesis that presence of epsilon4 affects sources of resting EEG rhythms in both MCI and AD subjects. We enrolled 89 MCI subjects (34.8% with epsilon4) and 103 AD patients (50.4% with epsilon4). Resting eyes-closed EEG data were recorded for all subjects. EEG rhythms of interest were delta (2-4 Hz), theta (4-8 Hz), alpha 1 (8-10.5 Hz), alpha 2 (10.5-13Hz), beta 1 (13-20 Hz), and beta 2 (20-30 Hz). EEG cortical sources were estimated by low-resolution brain electromagnetic tomography. Results showed that amplitude of alpha 1 and 2 sources in occipital, temporal, and limbic areas was lower in subjects carrying the epsilon4 allele than in those not carrying the epsilon4 allele (p neurophysiological phenotype (ie, cortical alpha rhythmicity) in a preclinical AD condition, MCI, in addition to clinically manifest AD. Such a demonstration motivates future genotype-EEG phenotype studies for the early prediction of AD conversion in individual MCI subjects.

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

    Directory of Open Access Journals (Sweden)

    Dijkgraaf Marcel G

    2010-03-01

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

  6. Management of pelvic lymphoceles after radical prostatectomy: A multicentre community based study

    Directory of Open Access Journals (Sweden)

    Khoder WY

    2011-06-01

    Full Text Available Abstract Introduction Pelvic lymphoceles (LC following radical prostatectomy (LC-RP have an incidence up to 27%. LC-managements constitute 50% of surgical interventions performed in post-RP patients. Objectives To describe a therapeutic algorithm for LC-managements based on a community based representative retrospective study. Patients and methods: Multicentre data from 304 patients with LC-RP were retrospectively examined for LC-managements. RPs were performed by various surgeons from 67 urological departments. All patients had undergone 3 weeks rehabilitation in a specialized hospital where the data base was generated. Indications and results of therapeutic manoeuvres were used to develop a general concept for planning therapy decisions. Results Median age was 64 years. Complications occurred in 9% (28/304 of patients. Median LC-volume was 36 ml (range 20-1800 ml. There were more complications for LCs with ≥100 ml volume than those Conclusions This study based treatment algorithm provides a rationale approach with an accurate LC-classification as regard the indications and decision making for the available LC-RP-therapies. This could facilitate management decisions. Evaluation of this concept prospectively in large patient cohort is mandatory.

  7. Clinical features of primary headache in children: a multicentre hospital-based study in France.

    Science.gov (United States)

    Cuvellier, J-C; Donnet, A; Guégan-Massardier, E; Nachit-Ouinekh, F; Parain, D; Vallée, L

    2008-11-01

    The aim of this study was to evaluate the concordance between clinical diagnosis and the International Classification of Headache Disorders, 2nd edn (ICHD-II) in children and adolescents with primary headaches. This 6-month prospective multicentre study of 486 patients (mean 9.8 +/- 3.1 years; 52.6% girls) assessed the headache features through a structured questionnaire. In 398 patients with a single type of headache, headaches were bilateral (78.1%), frontal (62.4%), pulsatile (56.1%), with associated symptoms in 84.4%. The most frequently assigned diagnoses were migraine without aura (50.8%), probable migraine (14.1%), migraine with aura (11.1%) and frequent episodic tension-type headache (7.5%). For most of the diagnostic categories, the consistency of the investigator's diagnosis with the ICHD-II criteria was good (kappa > 0.6 and 0.8). We conclude that migraine was predominant with regard to headache diagnoses repartition and that the ICHD-II seems usable in practice for evaluation of primary headache in French children and adolescents.

  8. Chikungunya Infection in India: Results of a Prospective Hospital Based Multi-Centric Study

    Science.gov (United States)

    Ray, Pratima; Ratagiri, Vinod H.; Kabra, Sushil K.; Lodha, Rakesh; Sharma, Sumit; Sharma, B. S.; Kalaivani, Mani; Wig, Naveet

    2012-01-01

    Background Chikungunya (CHIKV) has recently seen a re-emergence in India with high morbidity. However, the epidemiology and disease burden remain largely undetermined. A prospective multi-centric study was conducted to evaluate clinical, epidemiological and virological features of chikugunya infection in patients with acute febrile illness from various geographical regions of India. Methods and Findings A total of 540 patients with fever of up to 7days duration were enrolled at Karnataka Institute of Medical Sciences (KIMS), Karnataka (South); Sawai Man Singh Medical College (SMS) Rajasthan (West), and All India Institute of Medical Sciences (AIIMS) New Delhi (North) from June 2008 to May 2009. Serum specimens were screened for chikungunya infection concurrently through RT-PCR and serology (IgM). Phylogenetic analysis was performed using Bioedit and Mega2 programs. Chikungunya infection was detected in 25.37% patients by RT-PCR and/or IgM-ELISA. Highest cases were detected in south (49.36%) followed by west (16.28%) and north (0.56%) India. A difference in proportion of positives by RT-PCR/ELISA with regard to duration of fever was observed (pchikungunya confirmed cases (pchikungunya in high frequencies and severe morbidity in south and west India but rare in north. The study emphasizes the need for continuous surveillance for disease burden using multiple diagnostic tests and also warrants the need for an appropriate molecular diagnostic for early detection of chikungunya virus. PMID:22363413

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

    Directory of Open Access Journals (Sweden)

    Heeley Emma L

    2011-01-01

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

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

    LENUS (Irish Health Repository)

    Rashid, F

    2011-03-01

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

  11. A multicentric study to evaluate the use of relative retention times in targeted proteomics.

    Science.gov (United States)

    Vialas, Vital; Colomé-Calls, Núria; Abian, Joaquín; Aloria, Kerman; Alvarez-Llamas, Gloria; Antúnez, Oreto; Arizmendi, Jesus M; Azkargorta, Mikel; Barceló-Batllori, Silvia; Barderas, María G; Blanco, Francisco; Casal, J Ignacio; Casas, Vanessa; de la Torre, Carolina; Chicano-Gálvez, Eduardo; Elortza, Felix; Espadas, Guadalupe; Estanyol, Josep M; Fernandez-Irigoyen, Joaquín; Fernandez-Puente, Patricia; Fidalgo, María José; Fuentes, Manuel; Gay, Marina; Gil, Concha; Hainard, Alexandre; Hernaez, Maria Luisa; Ibarrola, Nieves; Kopylov, Arthur T; Lario, Antonio; Lopez, Juan Antonio; López-Lucendo, María; Marcilla, Miguel; Marina-Ramírez, Anabel; Marko-Varga, Gyorgy; Martín, Luna; Mora, Maria I; Morato-López, Esperanza; Muñoz, Javier; Odena, Maria Antonia; de Oliveira, Eliandre; Orera, Irene; Ortea, Ignacio; Pasquarello, Carla; Ray, Kevin B; Rezeli, Melinda; Ruppen, Isabel; Sabidó, Eduard; Del Pino, Manuel M Sanchez; Sancho, Jaime; Santamaría, Enrique; Vazquez, Jesus; Vilaseca, Marta; Vivanco, Fernando; Walters, James J; Zgoda, Victor G; Corrales, Fernando J; Canals, Francesc; Paradela, Alberto

    2017-01-30

    Despite the maturity reached by targeted proteomic strategies, reliable and standardized protocols are urgently needed to enhance reproducibility among different laboratories and analytical platforms, facilitating a more widespread use in biomedical research. To achieve this goal, the use of dimensionless relative retention times (iRT), defined on the basis of peptide standard retention times (RT), has lately emerged as a powerful tool. The robustness, reproducibility and utility of this strategy were examined for the first time in a multicentric setting, involving 28 laboratories that included 24 of the Spanish network of proteomics laboratories (ProteoRed-ISCIII). According to the results obtained in this study, dimensionless retention time values (iRTs) demonstrated to be a useful tool for transferring and sharing peptide retention times across different chromatographic set-ups both intra- and inter-laboratories. iRT values also showed very low variability over long time periods. Furthermore, parallel quantitative analyses showed a high reproducibility despite the variety of experimental strategies used, either MRM (multiple reaction monitoring) or pseudoMRM, and the diversity of analytical platforms employed.

  12. Iatrogenic facial nerve injuries during chronic otitis media surgery: a multicentre retrospective study.

    Science.gov (United States)

    Linder, T; Mulazimoglu, S; El Hadi, T; Darrouzet, V; Ayache, D; Somers, T; Schmerber, S; Vincent, C; Mondain, M; Lescanne, E; Bonnard, D

    2017-06-01

    To give an insight into why, when and where iatrogenic facial nerve (FN) injuries may occur and to explain how to deal with them in an emergency setting. Multicentre retrospective study in eight tertiary referral hospitals over 17 years. Twenty patients with partial or total FN injury during surgery for chronic otitis media (COM) were revised. Indication and type of surgery, experience of the surgeon, intra- and postoperative findings, value of CT scanning, patient management and final FN outcome were recorded. In 12 cases, the nerve was completely transected, but the surgeon was unaware in 11 cases. A minority of cases occurred in academic teaching hospitals. Tympanic segment, second genu and proximal mastoid segments were the sites involved during injury. The FN was not deliberately identified in 18 patients at the time of injury, and nerve monitoring was only applied in one patient. Before revision surgery, CT scanning correctly identified the lesion site in 11 of 12 cases and depicted additional lesions such as damage to the lateral semicircular canal. A greater auricular nerve graft was interposed in 10 cases of total transection and in one partially lesioned nerve: seven of them resulted in an HB III functional outcome. In two of the transected nerves, rerouting and direct end-to-end anastomosis was applied. A simple FN decompression was used in four cases of superficially traumatised nerves. We suggest checklists for preoperative, intraoperative and postoperative management to prevent and treat iatrogenic FN injury during COM surgery. © 2016 John Wiley & Sons Ltd.

  13. A prospective naturalistic multicentre study of intravenous medications in behavioural emergencies: haloperidol versus flunitrazepam.

    Science.gov (United States)

    Hatta, Kotaro; Nakamura, Mitsuru; Yoshida, Kenichi; Hamakawa, Hiroshi; Wakejima, Toru; Nishimura, Takao; Furuta, Ko; Kawabata, Toshitaka; Hirata, Toyoaki; Usui, Chie; Nakamura, Hiroyuki; Sawa, Yutaka

    2010-06-30

    A prospective naturalistic multicentre study for deep sedation was conducted in intensive care with continuous electrocardiogram (ECG) monitoring. Clinical purpose was enough sedation, which made uncooperative and disrupted patients receive brain computed tomography (CT), magnetic resonance imaging (MRI), or fluid therapy, with minimum drug doses. A first infusion was either haloperidol (HAL group) or flunitrazepam (FNP group). If enough sedation was not achieved, a second infusion, which was the opposite drug to the first infusion, was given. The proportion requiring a second infusion was higher in the HAL group than in the FNP group (82% vs. 36%, PFNP first group (FNP+HAL group) than the HAL first group (HAL+FNP group) (68% [S.D. 17] vs. 54% [S.D. 31], P=0.02). The mean dose of flunitrazepam in the HAL+FNP group was significantly lower than that in the FNP+HAL-group (1.3 mg vs. 3.5 mg, P=0.0003). Thus, in terms of monotherapy and speed of action, flunitrazepam has advantages over haloperidol as a first infusion for deep sedation. Regarding drug dosages, haloperidol has an advantage over flunitrazepam as a first infusion in safety.

  14. Occult cancer in specimens of reduction mammaplasty aimed at symmetrization. A multicentric study of 2718 patients.

    Science.gov (United States)

    Sorin, T; Fyad, J P; Delay, E; Rouanet, P; Rimareix, F; Houpeau, J L; Classe, J M; Garrido, I; Tunon De Lara, C; Dauplat, J; Bendavid, C; Houvenaeghel, G; Clough, K B; Sarfati, I; Leymarie, N; Trudel, M; Salleron, J; Guillemin, F; Oldrini, G; Brix, M; Dolivet, G; Simon, E; Verhaeghe, J L; Marchal, F

    2015-06-01

    Women who have undergone surgical treatment for breast cancer often benefit from a contralateral reduction mammaplasty (CRM) aimed at symmetrization of the contralateral breast unaffected by the initial cancer. In our 7-year multicentric study (12 centers) of 2718 patients, incidence of CRM cancers (CRMc) was 1.47% (n = 40) [95% CI 1.05%-2.00%]. The CRMc group had significantly more initial mammary cancers of invasive lobular carcinoma (ILC, 22.5% vs 12.0%) and ductal carcinoma in situ (DCIS, 35.0% vs 21.6%) types than the healthy CRM group (p = 0.017). 35.0% (n = 14) of patients had en bloc resection; 25.0% (n = 10) of surgical specimens were correctly oriented. En bloc resection and orientation of surgical specimens enable precise pinpointing of the CRMc. A salvage lumpectomy may be proposed as an option when margins are invaded. The histological distribution of the 40 CRMc (mean size 12.7 mm) was carcinoma in situ (CIS) 70%, ILC 12.5%, invasive ductal carcinoma (IDC) 12.5% and tubular carcinoma (TC) 5.0%. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Jose C. Flores-González

    2017-01-01

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

  16. Variability in drug use among newborns admitted to NICUs: a proposal for a European multicentre study

    Directory of Open Access Journals (Sweden)

    Laura Cuzzolin

    2014-01-01

    Full Text Available The use of drugs in newborns admitted to NICUs is characterized by a great variability. This widespread phenomenon, observed both within and between different countries, has been highlighted by reporting data on the treatment of neonatal sepsis and PDA throughout Europe: the dosages and the intervals between administrations of ciprofloxacin and fluconazole varied significantly and a wide variation was also observed as regards the use of NSAIDs to treat PDA. Given the unique characteristics of the neonatal population, the use of drugs on an individual basis could be sometimes justified. However, other factors such as the lack of evidence-based guidelines and the common use of drugs in an off-label manner (more than 80% of newborns receive this kind of treatment could contribute to the variability in medicine use, making the neonatal population vulnerable to adverse drug reactions (ADRs and medication errors: the potential ADRs rate, 3 times higher in pediatric wards, is more significantly higher in NICUs and the frequency of medication errors (mostly dose errors widely exceeds the medium value. The differences in clinical practices observed between NICUs need to be addressed at a European level and a multicentre study could be useful to harmonize drug use in newborns.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2012-07-15

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

  18. Ebrotidine versus ranitidine in the treatment of acute duodenal ulcer. A multicentre, randomized, double-blind, controlled clinical trial.

    Science.gov (United States)

    Matov, V; Metchkov, G; Krastev, Z; Tchernev, K; Mitova, R; Márquez, M; Torres, J; Herrero, E; Fillat, O; Ortiz, J A

    1997-04-01

    A total of 478 patients with endoscopically confirmed duodenal ulcer entered this randomized, parallel, double-blind trial. Patients were randomly assigned to receive ebrotidine (N-[(E)-[[2-[[[2-[(diaminomethylene)amino]- 4-thiazolyl]methyl]thio]ethyl]amino]methylene]-4-bromo-benzenesulfona mid e, CAS 100981-43-9, FI-3542) 400 mg or ranitidine 300 mg tablets (4:1) respectively, administered in single evening doses. Endoscopy, clinical examination and symptom assessment were performed at baseline and at weeks 4 and 8. Safety evaluations including laboratory tests, treatment compliance and antacid consumption checks were conducted at the beginning and/or at the 4 and 8 week visits. Patients whose ulcer showed endoscopic healing at the 4-week control left the study. Both groups were matched in all parameters studied. The healing rates at 4 weeks were 76.4% and 75.3% for ebrotidine and ranitidine respectively, while at 8 weeks the final rates were 95% and 91.8% respectively. Accompanying symptoms disappeared rapidly and the patients returned to normal. Smoking proved to be a highly significant negative risk factor, since healing rates were 83.4% and 71.2% at 4 weeks and 97.4% and 92.3% at 8 weeks in non-smokers and smokers respectively (p = 0.0046). Smokers treated with ranitidine showed significantly lower final healing rates than non-smokers (86% vs 100%; p = 0.0358), while the healing rates among patients treated with ebrotidine were similar regardless of whether they were smokers or not (93.9% and 96.7% N.S.). Ebrotidine (94%) proved to be more effective than ranitidine (86%) in smokers with higher healing rates (p < 0.05). Alcohol intake showed no significant relationship with the healing rates. Both drugs demonstrated an excellent safety. There were no changes in blood parameters, and no significant adverse events were reported.

  19. Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis: a multicentre randomized non-inferiority trial.

    Directory of Open Access Journals (Sweden)

    Luca Massacesi

    Full Text Available For almost three decades in many countries azathioprine has been used to treat relapsing-remitting multiple sclerosis. However its efficacy was usually considered marginal and following approval of β interferons for this indication it was no longer recommended as first line treatment, even if presently no conclusive direct β interferon-azathioprine comparison exists. To compare azathioprine efficacy versus the currently available β interferons in relapsing-remitting multiple sclerosis, a multicenter, randomized, controlled, single-blinded, non-inferiority trial was conducted in 30 Italian multiple sclerosis centers. Eligible patients (relapsing-remitting course; ≥ 2 relapses in the last 2 years were randomly assigned to azathioprine or β interferons. The primary outcome was annualized relapse rate ratio (RR over 2 years. Key secondary outcome was number of new brain MRI lesions. Patients (n = 150 were randomized in 2 groups (77 azathioprine, 73 β interferons. At 2 years, clinical evaluation was completed in 127 patients (62 azathioprine, 65 β interferons. Annualized relapse rate was 0.26 (95% Confidence Interval, CI, 0.19-0.37 in the azathioprine and 0.39 (95% CI 0.30-0.51 in the interferon group. Non-inferiority analysis showed that azathioprine was at least as effective as β interferons (relapse RRAZA/IFN 0.67, one-sided 95% CI 0.96; p<0.01. MRI outcomes were analyzed in 97 patients (50 azathioprine and 47 β interferons. Annualized new T2 lesion rate was 0.76 (95% CI 0.61-0.95 in the azathioprine and 0.69 (95% CI 0.54-0.88 in the interferon group. Treatment discontinuations due to adverse events were higher (20.3% vs. 7.8%, p = 0.03 in the azathioprine than in the interferon group, and concentrated within the first months of treatment, whereas in the interferon group discontinuations occurred mainly during the second year. The results of this study indicate that efficacy of azathioprine is not inferior to that of β interferons for

  20. Azathioprine versus Beta Interferons for Relapsing-Remitting Multiple Sclerosis: A Multicentre Randomized Non-Inferiority Trial

    Science.gov (United States)

    Massacesi, Luca; Tramacere, Irene; Amoroso, Salvatore; Battaglia, Mario A.; Benedetti, Maria Donata; Filippini, Graziella; La Mantia, Loredana; Repice, Anna; Solari, Alessandra; Tedeschi, Gioacchino; Milanese, Clara

    2014-01-01

    For almost three decades in many countries azathioprine has been used to treat relapsing-remitting multiple sclerosis. However its efficacy was usually considered marginal and following approval of β interferons for this indication it was no longer recommended as first line treatment, even if presently no conclusive direct β interferon-azathioprine comparison exists. To compare azathioprine efficacy versus the currently available β interferons in relapsing-remitting multiple sclerosis, a multicenter, randomized, controlled, single-blinded, non-inferiority trial was conducted in 30 Italian multiple sclerosis centers. Eligible patients (relapsing-remitting course; ≥2 relapses in the last 2 years) were randomly assigned to azathioprine or β interferons. The primary outcome was annualized relapse rate ratio (RR) over 2 years. Key secondary outcome was number of new brain MRI lesions. Patients (n = 150) were randomized in 2 groups (77 azathioprine, 73 β interferons). At 2 years, clinical evaluation was completed in 127 patients (62 azathioprine, 65 β interferons). Annualized relapse rate was 0.26 (95% Confidence Interval, CI, 0.19–0.37) in the azathioprine and 0.39 (95% CI 0.30–0.51) in the interferon group. Non-inferiority analysis showed that azathioprine was at least as effective as β interferons (relapse RRAZA/IFN 0.67, one-sided 95% CI 0.96; p<0.01). MRI outcomes were analyzed in 97 patients (50 azathioprine and 47 β interferons). Annualized new T2 lesion rate was 0.76 (95% CI 0.61–0.95) in the azathioprine and 0.69 (95% CI 0.54–0.88) in the interferon group. Treatment discontinuations due to adverse events were higher (20.3% vs. 7.8%, p = 0.03) in the azathioprine than in the interferon group, and concentrated within the first months of treatment, whereas in the interferon group discontinuations occurred mainly during the second year. The results of this study indicate that efficacy of azathioprine is not inferior to that of

  1. Poison prevention practices and medically attended poisoning in young children: multicentre case-control study.

    Science.gov (United States)

    Kendrick, Denise; Majsak-Newman, Gosia; Benford, Penny; Coupland, Carol; Timblin, Clare; Hayes, Mike; Goodenough, Trudy; Hawkins, Adrian; Reading, Richard

    2017-04-01

    Childhood poisonings are common, placing a substantial burden on health services. Case-control studies have found inconsistent evidence about modifiable risk factors for poisonings among children aged 0-4 years. This study quantifies associations between poison prevention practices and medically attended poisonings in children aged 0-4 years. Multicentre case-control study conducted at hospitals, minor injury units and family practices from four study centres in England between 2010 and 2013. Participants comprised 567 children presenting with unintentional poisoning occurring at home and 2320 community control participants matched on age, sex, date of event and study centre. Parents/caregivers provided data on safety practices, safety equipment use, home hazards and potential confounders by means of self-completion questionnaires. Data were analysed using conditional logistic regression. Compared with community controls, parents of poisoned children were significantly more likely not to store medicines out of reach (adjusted OR (AOR) 1.59; 95% CI 1.21 to 2.09; population attributable fraction (PAF) 15%), not to store medicines safely (locked or out of reach (AOR 1.83; 95% CI 1.38 to 2.42; PAF 16%) and not to have put all medicines (AOR 2.11; 95% CI 1.54 to 2.90; PAF 20%) or household products (AOR 1.79, 95% CI 1.29 to 2.48; PAF 11%) away immediately after use. Not storing medicines out of reach or locked away and not putting medicines and household products away immediately after use increased the odds of secondary care attended poisonings in children aged 0-4 years. If associations are causal, implementing these poison prevention practices could each prevent between 11% and 20% of poisonings. 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/.

  2. BariSurg trial: Sleeve gastrectomy versus Roux-en-Y gastric bypass in obese patients with BMI 35–60 kg/m2 – a multi-centre randomized patient and observer blind non-inferiority trial

    OpenAIRE

    2015-01-01

    Background: Roux-en-Ygastric bypass (RYGB) and sleeve gastrectomy (SG) rank among the most frequently applied bariatric procedures worldwide due to their positive risk/benefit correlation. A systematic review revealed a similar excess weight loss (EWL) 2 years postoperatively between SG and RYGB. However, there is a lack of randomized controlled multi-centre trials comparing SG and RYGB, not only concerning EWL, but also in terms of remission of obesity-related co-morbidities, gastroesophagea...

  3. Exposure assessment for a multicentric cohort study of cancer risk among European asphalt workers

    NARCIS (Netherlands)

    Burstyn, I.

    2001-01-01

    There is a long-standing controversy about the health effects of fumes and vapors generated during paving and waterproofing with bitumen. Such emissions may be carcinogenic. To address this question, a historical multicentric cohort of asphalt workers was assembled by in eight coun

  4. Perception and use of massive open online courses among medical students in a developing country: multicentre cross-sectional study

    Science.gov (United States)

    Aboshady, Omar A; Radwan, Ahmed E; Eltaweel, Asmaa R; Azzam, Ahmed; Aboelnaga, Amr A; Hashem, Heba A; Darwish, Salma Y; Salah, Rehab; Kotb, Omar N; Afifi, Ahmed M; Noaman, Aya M; Salem, Dalal S; Hassouna, Ahmed

    2015-01-01

    Objectives To assess the prevalence of awareness and use of massive open online courses (MOOCs) among medical undergraduates in Egypt as a developing country, as well as identifying the limitations and satisfaction of using these courses. Design A multicentre, cross-sectional study using a web-based, pilot-tested and self-administered questionnaire. Settings Ten out of 19 randomly selected medical schools in Egypt. Participants 2700 undergraduate medical students were randomly selected, with an equal allocation of participants in each university and each study year. Primary and secondary outcome measures Primary outcome measures were the percentages of students who knew about MOOCs, students who enrolled and students who obtained a certificate. Secondary outcome measures included the limitations and satisfaction of using MOOCs through five-point Likert scale questions. Results Of 2527 eligible students, 2106 completed the questionnaire (response rate 83.3%). Of these students, 456 (21.7%) knew the term MOOCs or websites providing these courses. Out of the latter, 136 (29.8%) students had enrolled in at least one course, but only 25 (18.4%) had completed courses earning certificates. Clinical year students showed significantly higher rates of knowledge (p=0.009) and enrolment (p<0.001) than academic year students. The primary reasons for the failure of completion of courses included lack of time (105; 77.2%) and slow Internet speed (73; 53.7%). Regarding the 25 students who completed courses, 21 (84%) were satisfied with the overall experience. However, there was less satisfaction regarding student–instructor (8; 32%) and student–student (5; 20%) interactions. Conclusions About one-fifth of Egyptian medical undergraduates have heard about MOOCs with only about 6.5% actively enrolled in courses. Students who actively participated showed a positive attitude towards the experience, but better time-management skills and faster Internet connection speeds are required

  5. Relationship between radiological grading and clinical status in knee osteoarthritis. a multicentric study

    Directory of Open Access Journals (Sweden)

    Hernández-Vaquero Daniel

    2012-10-01

    Full Text Available Abstract Background Controversy exists regarding the relationship between radiographic findings and clinical status in knee osteoarthritis. Although the surgical indication for total knee arthroplasty (TKA should be based on pain, clinical status, and the deterioration of quality of life, the radiographic study is the most commonly used criterion for preoperative evaluation. The objective of this study is to find out the relationship between the Ahlbäck classification and clinical status in patients undergoing TKA. Methods 1329 protocols were collected from preoperative studies in four multicentric working groups (the Interax, Duracon, Scorpio, and Triathlon Spanish groups in 30 Spanish hospitals. Mean age was 70.4 years (SD: 6.8; range: 35 to 98; 76.3% of patients were women. Patients entered the study whenever the surgeon found that medical treatment was insufficient to control pain and functional limitation. Data were collected using electronic Case Report Forms, and included Ahlbäck grading scores, Hospital for Special Surgery Knee Score (HSS, SF-12, and other clinical and epidemiologic variables. Results According to the Ahlbäck grading system, patients were divided as follows: 243 grade I (18.3%, 358 grade II (26.9%, 416 grade III (31.3%, 241 grade IV (18.1%, and 71 grade V (5.3%. As for HSS, the following scores were obtained: Conclusions We found a relationship between Ahlbäck grading and the preoperative clinical score. The range of variability of the HSS score between the different Ahlbäck grades is small.

  6. 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.

  7. The RESPIRE trials: Two phase III, randomized, multicentre, placebo-controlled trials of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in non-cystic fibrosis bronchiectasis.

    Science.gov (United States)

    Aksamit, Timothy; Bandel, Tiemo-Joerg; Criollo, Margarita; De Soyza, Anthony; Elborn, J Stuart; Operschall, Elisabeth; Polverino, Eva; Roth, Katrin; Winthrop, Kevin L; Wilson, Robert

    2017-07-01

    The primary goals of long-term disease management in non-cystic fibrosis bronchiectasis (NCFB) are to reduce the number of exacerbations, and improve quality of life. However, currently no therapies are licensed for this. Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) has potential to be the first long-term intermittent therapy approved to reduce exacerbations in NCFB patients. The RESPIRE programme consists of two international phase III prospective, parallel-group, randomized, double-blinded, multicentre, placebo-controlled trials of the same design. Adult patients with idiopathic or post-infectious NCFB, a history of ≥2 exacerbations in the previous 12months, and positive sputum culture for one of seven pre-specified pathogens, undergo stratified randomization 2:1 to receive twice-daily Ciprofloxacin DPI 32.5mg or placebo using a pocket-sized inhaler in one of two regimens: 28days on/off treatment or 14days on/off treatment. The treatment period is 48weeks plus an 8-week follow-up after the last dose. The primary efficacy endpoints are time to first exacerbation after treatment initiation and frequency of exacerbations using a stringent definition of exacerbation. Secondary endpoints, including frequency of events using different exacerbation definitions, microbiology, quality of life and lung function will also be evaluated. The RESPIRE trials will determine the efficacy and safety of Ciprofloxacin DPI. The strict entry criteria and stratified randomization, the inclusion of two treatment regimens and a stringent definition of exacerbation should clarify the patient population best positioned to benefit from long-term inhaled antibiotic therapy. Additionally RESPIRE will increase understanding of NCFB treatment and could lead to an important new therapy for sufferers. The RESPIRE trials are registered in ClinicalTrials.gov, ID number NCT01764841 (RESPIRE 1; date of registration January 8, 2013) and NCT02106832 (RESPIRE 2; date of registration

  8. The prevalence and specific characteristics of hospitalised pressure ulcer patients: A multicentre cross-sectional study.

    Science.gov (United States)

    Zhou, Qing; Yu, Ting; Liu, Yuan; Shi, Ruifen; Tian, Suping; Yang, Chaoxia; Gan, Huaxiu; Zhu, Yanying; Liang, Xia; Wang, Ling; Wu, Zhenhua; Huang, Jinping; Hu, Ailing

    2017-08-17

    The present study aimed to ascertain the pressure ulcer prevalence in secondary and tertiary general hospitals in different areas of Guangdong Province in China and explore the possible risk factors that are related to pressure ulcers. Few multicentre studies have been conducted on pressure ulcer prevalence in Chinese hospitals. A cross-sectional study design was used. Data from a total of 25,264 patients were included in the analysis at 25 hospitals in China. The investigators were divided into two groups. The investigators in Group 1 examined the patients' skin. When a pressure ulcer was found, a pressure ulcers assessment form was completed. The investigators in group 2 provided guidance to the nurses, who assessed all patients and completed another questionnaire. A multivariate logistic regression analysis was used to analyse the relationship between the possible risk factors and pressure ulcer. The overall prevalence rate of pressure ulcers in the 25 hospitals ranged from 0% to 3.49%, with a mean of 1.26%. The most common stage of the pressure ulcers was stage II (41.4%), most common anatomical locations were sacrum (39.5%) and the feet (16.4%). Braden score (ppressure ulcers from the multivariate logistic regression analysis. The overall prevalence rate of pressure ulcers in Chinese hospitals was lower than that reported in previous investigations. Specific characteristics of pressure ulcer patients were: low Braden score, longer expected length of stay, double incontinence, an ICU and a medical ward, hospital location in the Pearl River Delta, a university hospital, and an elderly patient. The survey could make managers know their prevalence level of pressure ulcers and provide priorities for clinical nurses. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  9. Knowledge, Attitudes, and Smoking Behaviours among Physicians Specializing in Public Health: A Multicentre Study

    Directory of Open Access Journals (Sweden)

    Giuseppe La Torre

    2014-01-01

    Full Text Available Background. Healthcare professionals have an important role to play both as advisers—influencing smoking cessation—and as role models. However, many of them continue to smoke. The aims of this study were to examine smoking prevalence, knowledge, attitudes, and behaviours among four cohorts physicians specializing in public health, according to the Global Health Profession Students Survey (GHPSS approach. Materials and Methods. A multicentre cross-sectional study was carried out in 24 Italian schools of public health. The survey was conducted between January and April 2012 and it was carried out a census of students in the selected schools for each years of course (from first to fourth year of attendance, therefore among four cohorts of physicians specializing in Public Health (for a total of n. 459 medical doctors. The GHPSS questionnaires were self-administered via a special website which is created ad hoc for the survey. Logistic regression model was used to identify possible associations with tobacco smoking status. Hosmer-Lemeshow test was performed. The level of significance was P≤0.05. Results. A total of 388 answered the questionnaire on the website (85%, of which 81 (20.9% declared to be smokers, 309 (79.6% considered health professionals as behavioural models for patients, and 375 (96.6% affirmed that health professionals have a role in giving advice or information about smoking cessation. Although 388 (89.7% heard about smoking related issues during undergraduate courses, only 17% received specific smoking cessation training during specialization. Conclusions. The present study highlights the importance of focusing attention on smoking cessation training, given the high prevalence of smokers among physicians specializing in public health, their key role both as advisers and behavioural models, and the limited tobacco training offered in public health schools.

  10. Knowledge, attitudes, and smoking behaviours among physicians specializing in public health: a multicentre study.

    Science.gov (United States)

    La Torre, Giuseppe; Saulle, Rosella; Unim, Brigid; Angelillo, Italo Francesco; Baldo, Vincenzo; Bergomi, Margherita; Cacciari, Paolo; Castaldi, Silvana; Del Corno, Giuseppe; Di Stanislao, Francesco; Panà, Augusto; Gregorio, Pasquale; Grillo, Orazio Claudio; Grossi, Paolo; La Rosa, Francesco; Nante, Nicola; Pavia, Maria; Pelissero, Gabriele; Quarto, Michele; Ricciardi, Walter; Romano, Gabriele; Schioppa, Francesco Saverio; Fallico, Roberto; Siliquini, Roberta; Triassi, Maria; Vitale, Francesco; Boccia, Antonio

    2014-01-01

    Healthcare professionals have an important role to play both as advisers-influencing smoking cessation-and as role models. However, many of them continue to smoke. The aims of this study were to examine smoking prevalence, knowledge, attitudes, and behaviours among four cohorts physicians specializing in public health, according to the Global Health Profession Students Survey (GHPSS) approach. A multicentre cross-sectional study was carried out in 24 Italian schools of public health. The survey was conducted between January and April 2012 and it was carried out a census of students in the selected schools for each years of course (from first to fourth year of attendance), therefore among four cohorts of physicians specializing in Public Health (for a total of n. 459 medical doctors). The GHPSS questionnaires were self-administered via a special website which is created ad hoc for the survey. Logistic regression model was used to identify possible associations with tobacco smoking status. Hosmer-Lemeshow test was performed. The level of significance was P ≤ 0.05. A total of 388 answered the questionnaire on the website (85%), of which 81 (20.9%) declared to be smokers, 309 (79.6%) considered health professionals as behavioural models for patients, and 375 (96.6%) affirmed that health professionals have a role in giving advice or information about smoking cessation. Although 388 (89.7%) heard about smoking related issues during undergraduate courses, only 17% received specific smoking cessation training during specialization. The present study highlights the importance of focusing attention on smoking cessation training, given the high prevalence of smokers among physicians specializing in public health, their key role both as advisers and behavioural models, and the limited tobacco training offered in public health schools.

  11. Multicentric observational study of pain after the use of a self-gripping lightweight mesh.

    Science.gov (United States)

    García Ureña, M Á; Hidalgo, M; Feliu, X; Velasco, M Á; Revuelta, S; Gutiérrez, R; Utrera, A; Porrero, J L; Marín, M; Zaragoza, C

    2011-10-01

    Investigation in the field of inguinal hernia surgery is now focused on postoperative pain. The extended use of lightweight meshes and alternative methods of fixation may play a relevant role in the reduction of pain. In this study, a new self-gripping lightweight polypropylene mesh is tested. A multicentric, observational study was scheduled to prospectively evaluate this new mesh. Ten centers agreed to participate. Only primary, type 1 or 2 uncomplicated hernias in adults were included. The mesh was placed as a Lichtenstein procedure without any fixation. A complete pain questionnaire was followed at 1 week, and at 1, 3 and 6 months postoperatively. The principal goal of the study was to evaluate maximum pain score at 6 months. Pain was assessed by a visual analog scale. A total of 256 patients were operated. Mean operative time was 35.6 min; 76.2% of patients were operated in an ambulatory setting. There were a few postoperative complications: 2 wound infections, 17 seromas, 21 hematomas, 6 orchitis. The incidence of acute pain was 27.3% at week 1 and 7.5% at month 1. The incidence of chronic pain was 3.6% at month 3 and 2.8% at month 6. No recurrences or long-term complications were observed. This self-gripping mesh can be used safely in type 1 and 2 primary, uncomplicated inguinal hernia with minimal morbidity and most patients under ambulatory setting. The registered incidence of chronic pain is lower than 3%.

  12. Analysis of GPR101 and AIP genes mutations in acromegaly: a multicentric study.

    Science.gov (United States)

    Ferraù, Francesco; Romeo, P D; Puglisi, S; Ragonese, M; Torre, M L; Scaroni, C; Occhi, G; De Menis, E; Arnaldi, G; Trimarchi, F; Cannavò, S

    2016-12-01

    This multicentric study aimed to investigate the prevalence of the G protein-coupled receptor 101 (GPR101) p.E308D variant and aryl hydrocarbon receptor interacting protein (AIP) gene mutations in a representative cohort of Italian patients with acromegaly. 215 patients with GH-secreting pituitary adenomas, referred to 4 Italian referral centres for pituitary diseases, have been included. Three cases of gigantism were present. Five cases were classified as FIPA. All the patients have been screened for germline AIP gene mutations and GPR101 gene p.E308D variant. Heterozygous AIP gene variants have been found in 7 patients (3.2 %). Five patients carried an AIP mutation (2.3 %; 4 females): 3 patients harboured the p.R3O4Q mutation, one had the p.R304* mutation and the last one the IVS3+1G>A mutation. The prevalence of AIP mutations was 3.3 % and 2.8 % when considering only the patients diagnosed when they were <30 or <40-year old, respectively. Furthermore, 2.0 % of the patients with a pituitary macroadenoma and 4.2 % of patients resistant to somatostatin analogues treatment were found to harbour an AIP gene mutation. None of the patients was found to carry the GPR101 p.E308D variant. The prevalence of AIP gene mutations among our sporadic and familial acromegaly cases was similar to that one reported in previous studies, but lower when considering only the cases diagnosed before 40 years of age. The GPR101 p.E308D change is unlikely to have a role in somatotroph adenomas tumorigenesis, since none of our sporadic or familial patients tested positive for this variant.

  13. Quality of bowel cleansing in hospitalized patients undergoing colonoscopy: A multicentre prospective regional study.

    Science.gov (United States)

    Rotondano, Gianluca; Rispo, Antonio; Bottiglieri, Maria E; De Luca, Leonardo; Lamanda, Roberto; Orsini, Luigi; Bruzzese, Dario; Galloro, Giuseppe; Romano, Marco; Miranda, Agnese; Loguercio, Carmelina; Esposito, Pasquale; Nardone, Gerardo; Compare, Debora; Magno, Luca; Ruggiero, Simona; Imperatore, Nicola; De Palma, Giovanni D; Gennarelli, Nicola; Cuomo, Rosario; Passananti, Valentina; Cirillo, Michele; Cattaneo, Domenico; Bozzi, Rosa Maria; D'Angelo, Valentina; Marone, Piero; Riccio, Elisabetta; De Nucci, Claudio; Monastra, Santo; Caravelli, Giancarlo; Verde, Clelia; Di Giorgio, Pietro; Giannattasio, Francesco; Capece, Giuseppe; Taranto, Domenico; De Seta, Massimiliano; Spinosa, Giuseppe; De Stefano, Salvatore; Familiari, Valeria; Cipolletta, Livio; Bianco, Maria Antonia; Sansone, Stefano; Galasso, Giovanni; De Colibus, Patrizia; Romano, Maurizio; Borgheresi, Patrizia; Ricco, Giovanni; Martorano, Marco; Gravina, Antonietta Gerarda; Marmo, Riccardo; Rea, Matilde; Maurano, Attilio; Labianca, Orazio; Colantuoni, Enrico; Iuliano, Donato; Trovato, Claudio; Fontana, Aldo; Pasquale, Luigi; Morante, Aristide; Perugini, Bruno; Scaglione, Giuseppe; Mauro, Biagio

    2015-08-01

    Quality of bowel cleansing in hospitalized patients undergoing colonoscopy is often unsatisfactory. No study has investigated the inpatient or outpatient setting as cause of inadequate cleansing. To assess degree of bowel cleansing in inpatients and outpatients and to identify possible predictors of poor bowel preparation in the two populations. Prospective multicentre study on consecutive colonoscopies in 25 regional endoscopy units. Univariate and multivariate analysis with odds ratio estimation were performed. Data from 3276 colonoscopies were analyzed (2178 outpatients, 1098 inpatients). Incomplete colonoscopy due to inadequate cleansing was recorded in 369 patients (11.2%). There was no significant difference in bowel cleansing rates between in- and outpatients in both colonic segments. In the overall population, independent predictors of inadequate cleansing both at the level of right and left colon were: male gender (odds ratio, 1.20 [1.02-1.43] and 1.27 [1.05-1.53]), diabetes mellitus (odds ratio, 2.35 [1.68-3.29] and 2.12 [1.47-3.05]), chronic constipation (odds ratio, 1.60 [1.30-1.97] and 1.55 [1.23-1.94]), incomplete purge intake (odds ratio, 2.36 [1.90-2.94] and 2.11 [1.68-2.65]) and a runway time >12h (odds ratio, 3.36 [2.40-4.72] and 2.53 [1.74-3.67]). We found no difference in the rate of inadequate bowel preparation between hospitalized patients and outpatients. Copyright © 2015 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  14. Linezolid-resistant staphylococcal bacteraemia: A multicentre case-case-control study in Italy.

    Science.gov (United States)

    Russo, Alessandro; Campanile, Floriana; Falcone, Marco; Tascini, Carlo; Bassetti, Matteo; Goldoni, Paola; Trancassini, Maria; Della Siega, Paola; Menichetti, Francesco; Stefani, Stefania; Venditti, Mario

    2015-03-01

    The aim of this multicentre study was to analyse the characteristics of patients with bloodstream infections due to staphylococcal strains resistant to linezolid. This was a retrospective case-case-control study of patients hospitalised in three large teaching hospitals in Italy. A linezolid-resistant (LIN-R) Staphylococcus spp. group and a linezolid-susceptible (LIN-S) Staphylococcus spp. group were compared with control patients to determine the clinical features and factors associated with isolation of LIN-R strains. All LIN-R Staphylococcus spp. strains underwent molecular typing. Compared with the LIN-S group, central venous catheters were the main source of infection in the LIN-R group. The LIN-R and LIN-S groups showed a similar incidence of severe sepsis or septic shock, and both showed a higher incidence of these compared with the control group. Overall, patients in the LIN-R group had a higher 30-day mortality rate. Multivariate analysis found previous linezolid therapy, linezolid therapy >14 days, antibiotic therapy in the previous 30 days, antibiotic therapy >14 days, previous use of at least two antibiotics and hospitalisation in the previous 90 days as independent risk factors associated with isolation of a LIN-R strain. The G2576T mutation in domain V of 23S rRNA was the principal mechanism of resistance; only one strain of Staphylococcus epidermidis carried the cfr methylase gene (A2503), together with L4 insertion (71GGR72) and L3 substitution (H146Q). LIN-R strains are associated with severe impairment of clinical conditions and unfavourable patient outcomes. Reinforcement of infection control measures may have an important role in preventing these infections.

  15. Blunt Cardiac Injury in the Severely Injured - A Retrospective Multicentre Study.

    Directory of Open Access Journals (Sweden)

    Marc Hanschen

    Full Text Available Blunt cardiac injury is a rare trauma entity. Here, we sought to evaluate the relevance and prognostic significance of blunt cardiac injury in severely injured patients.In a retrospective multicentre study, using data collected from 47,580 patients enrolled to TraumaRegister DGU (1993-2009, characteristics of trauma, prehospital / hospital trauma management, and outcome analysis were correlated to the severity of blunt cardiac injury. The severity of cardiac injury was assessed according to the abbreviated injury score (AIS score 1-6, the revised injury severity score (RISC allowed comparison of expected outcome with injury severity-dependent outcome. N = 1.090 had blunt cardiac trauma (AIS 1-6 (2.3% of patients.Predictors of blunt cardiac injury could be identified. Sternal fractures indicate a high risk of the presence of blunt cardiac injury (AIS 0 [control]: 3.0%; AIS 1: 19.3%; AIS 2-6: 19.1%. The overall mortality rate was 13.9%, minor cardiac injury (AIS 1 and severe cardiac injury (AIS 2-6 are associated with higher rates. Severe blunt cardiac injury (AIS 4 and AIS 5-6 is associated with a higher mortality (OR 2.79 and 4.89, respectively as compared to the predicted average mortality (OR 2.49 of the study collective.Multiple injured patients with blunt cardiac trauma are at high risk to be underestimated. Careful evaluation of trauma patients is able to predict the presence of blunt cardiac injury. The severity of blunt cardiac injury needs to be stratified according to the AIS score, as the patients' outcome is dependent on the severity of cardiac injury.

  16. Assessing structure, process and outcome in palliative day care: a pilot study for a multicentre trial.

    Science.gov (United States)

    Douglas, Hannah-Rose; Higginson, Irene J.; Myers, Kathryn; Normand, Charles

    2000-09-01

    Palliative day care is an expanding service which remains under-researched. Study designs need to be developed to evaluate the costs and outcomes of the service in ways which are meaningful to patients, clinicians and policy-makers. At the same time, these must be open to the same criteria for rigour and reliability as techniques used elsewhere in health and social service evaluation. To this end, a developmental stage of exploratory research was undertaken at the start of a major multicentre trial of palliative day care to meet two clear aims: to understand more about the structure and processes of palliative day care, and to identify ways in which service outcomes could be evaluated and measured. In-depth observations at five palliative day care centres were undertaken across one health region. This provided a better understanding of the models, outcomes and processes of palliative day care in five different environments. Centres represented the spectrum of medical and social care models and findings were analysed using an organisational systems approach. The findings showed that, despite the lack of a national strategic approach to developing the service, the centres all provided a core set of services which were broadly similar. However, differences in philosophy, ownership, and organisation affected how the services were provided and may have an impact on the costs of the service. The study has provided a more in-depth understanding of palliative day care services in order to design an effective research strategy for evaluating a service which crosses the boundaries of health and social care.

  17. An Italian multicentre validation study of the coma recovery scale-revised.

    Science.gov (United States)

    Estraneo, A; Moretta, P; De Tanti, A; Gatta, G; Giacino, J T; Trojano, L

    2015-10-01

    Rate of misdiagnosis of disorders of consciousness (DoC) can be reduced by employing validated clinical diagnostic tools, such as the Coma Recovery Scale-Revised (CRS-R). An Italian version of the CRS-R has been recently developed, but its applicability across different clinical settings, and its concurrent validity and diagnostic sensitivity have not been estimated yet. To perform a multicentre validation study of the Italian version of the Coma Recovery Scale-Revised (CRS-R). Analysis of inter-rater reliability, concurrent validity and diagnostic sensitivity of the scale. One Intensive Care Unit, 8 Post-acute rehabilitation centres and 2 Long-term facilities Twenty-seven professionals (physicians, N.=11; psychologists, N.=5; physiotherapists, N.=3; speech therapists, N.=6; nurses, N.=2) from 11 Italian Centres. CRS-R and Disability Rating Scale (DRS) applied to 122 patients with clinical diagnosis of Vegetative State (VS) or Minimally Conscious State (MCS). CRS-R has good-to-excellent inter-rater reliability for all subscales, particularly for the communication subscale. The Italian version of the CRS-R showed a high sensitivity and specificity in detecting MCS with reference to clinical consensus diagnosis. The CRS-R showed good concurrent validity with the Disability Rating Scale, which had very low specificity with reference to clinical consensus diagnosis. The Italian version of the CRS-R is a valid scale for use from the sub-acute to chronic stages of DoC. It can be administered reliably by all members of the rehabilitation team with different specialties, levels of experience and settings. The present study promote use of the Italian version of the CRS-R to improve diagnosis of DoC patients, and plan tailored rehabilitation treatment.

  18. Lifelong vegetarianism and breast cancer risk: a large multicentre case control study in India.

    Science.gov (United States)

    Gathani, Toral; Barnes, Isobel; Ali, Raghib; Arumugham, Rajkumar; Chacko, Raju; Digumarti, Raghunadharao; Jivarajani, Parimal; Kannan, Ravi; Loknatha, Dasappa; Malhotra, Hemant; Mathew, Beela S

    2017-01-18

    The lower incidence of breast cancer in Asian populations where the intake of animal products is lower than that of Western populations has led some to suggest that a vegetarian diet might reduce breast cancer risk. Between 2011 and 2014 we conducted a multicentre hospital based case-control study in eight cancer centres in India. Eligible cases were women aged 30-70 years, with newly diagnosed invasive breast cancer (ICD10 C50). Controls were frequency matched to the cases by age and region of residence and chosen from the accompanying attendants of the patients with cancer or those patients in the general hospital without cancer. Information about dietary, lifestyle, reproductive and socio-demographic factors were collected using an interviewer administered structured questionnaire. Multivariate logistic regression models were used to estimate the odds ratio (OR) and 95% confidence intervals for the risk of breast cancer in relation to lifelong vegetarianism, adjusting for known risk factors for the disease. The study included 2101 cases and 2255 controls. The mean age at recruitment was similar in cases (49.7 years (SE 9.7)) and controls (49.8 years (SE 9.1)). About a quarter of the population were lifelong vegetarians and the rates varied significantly by region. On multivariate analysis, with adjustment for known risk factors for the disease, the risk of breast cancer was not decreased in lifelong vegetarians (OR 1.09 (95% CI 0.93-1.29)). Lifelong exposure to a vegetarian diet appears to have little, if any effect on the risk of breast cancer.

  19. Occupational factors and risk of adult bone sarcomas: a multicentric case-control study in Europe.

    Science.gov (United States)

    Merletti, Franco; Richiardi, Lorenzo; Bertoni, Franco; Ahrens, Wolfgang; Buemi, Antoine; Costa-Santos, Cristina; Eriksson, Mikael; Guénel, Pascal; Kaerlev, Linda; Jöckel, Karl-Heinz; Llopis-Gonzalez, Agustin; Merler, Enzo; Miranda, Ana; Morales-Suárez-Varela, Maria M; Olsson, Håkan; Fletcher, Tony; Olsen, Jorn

    2006-02-01

    We investigated the association between occupational factors and risk of bone sarcoma, a rare tumor with a largely unknown aetiology. A multicentric case-control study was conducted in 7 European countries in 1995-97. Ninety-six cases aged 35-69 years with a centrally reviewed diagnosis of bone sarcoma (68 chondrosarcomas and 28 osteosarcomas) were compared to 2,632 population (68%) or colon cancer (32%) controls. Subjects were interviewed to obtain information on occupational, medical and reproductive history, smoking and alcohol consumption and selected exposures including use of pesticides. Response proportions were 90% among cases and 66% among controls. Odds ratios (OR) and 95% confidence intervals (CI) were estimated for selected categories of job titles and branches of industry and for use of pesticides. We found an increased OR for bone sarcoma among blacksmiths, toolmakers, machine-tool operators (OR = 2.14, 95% CI 1.08-4.26), woodworkers (OR = 2.68, 95% CI 1.36-5.29) and construction workers (OR = 1.62, 95% CI 0.92-2.87). Ever users of pesticide had an OR of 2.33 (95% CI 1.31-4.13), with similar risks for exposure to insecticides and exposure to herbicides. Neither duration of employment in any of the analyzed occupational categories nor duration of use of pesticides showed an increasing trend in the risk of bone sarcoma. ORs of bone sarcoma were 1.03 (95% CI 0.23-4.57), 3.13 (95% CI 1.26-7.76) and 1.44 (95% CI 0.43-4.85) for the first, second and third tertile of days of use of pesticides. Our study suggests that novel and previously reported (woodworking) occupational factors play a role in the aetiology of bone sarcomas.

  20. Incidence of nutritional support complications in patient hospitalized in wards. multicentric study

    Directory of Open Access Journals (Sweden)

    Gloria María Agudelo Ochoa

    2012-06-01

    Full Text Available Introduction: Nutritional support generates complications that must be detected and treated on time. Objective: To estimate the incidence of some complications of nutritional support in patients admitted to general hospital wards who received nutritional support in six high-complexity institutions. Methods: Prospective, descriptive and multicentric study in patients with nutritional support; the variables studied were medical diagnosis, nutritional condition, nutritional support duration, approach, kind of formula, and eight complications. Results: A total of 277 patients were evaluated; 83% received enteral nutrition and 17% received parenteral nutrition. Some 69.3% presented risk of malnourishment or severe malnourishment at admittance. About 35.4% of those receiving enteral nutrition and 39.6% of the ones who received parenteral nutrition had complications; no significant difference per support was found (p = 0.363. For the enteral nutrition, the most significant complication was the removal of the catheter (14%, followed by diarrhea (8.3%; an association between the duration of the enteral support with diarrhea, constipation and removal of the catheter was found (p < 0.05. For parenteral nutrition, hyperglycemia was the complication of highest inci­dence (22.9%, followed by hypophosphatemia (12.5%; all complications were associated with the duration of the support (p < 0.05. Nutritional support was suspended in 24.2% of the patients. Conclusions: Complications with nutritional support in hospital-ward patients were frequent, with the removal of the catheter and hyperglycemia showing the highest incidence. Duration of the support was the variable that revealed an asso­ciation with complications. Strict application of protocols could decrease the risk for complications and boost nutritional support benefits.

  1. Oral iloprost as a treatment for Raynaud's syndrome: a double blind multicentre placebo controlled study.

    Science.gov (United States)

    Belch, J J; Capell, H A; Cooke, E D; Kirby, J D; Lau, C S; Madhok, R; Murphy, E; Steinberg, M

    1995-01-01

    OBJECTIVE--To compare the efficacy, tolerance and safety of 50-150 micrograms orally administered iloprost given twice a day versus placebo in patients with Raynaud's syndrome. METHODS--The study was multicentre (n = 3), double blind and placebo controlled. Sixty three patients who had eight or more vasospastic attacks per week were enrolled. After a one week run-in period, all patients received either iloprost or placebo treatment to a maximum tolerated dose of 150 micrograms twice a day for 10 days. Diary cards assessed the duration and severity of the vasospastic attacks. Side effects were monitored by direct questioning. A global assessment of treatment efficacy was made by the patient at the end of treatment and two weeks later. RESULTS--Patient opinion tended to favour iloprost at the end of the 10 day treatment phase (p = 0.09) and this was significant at day 24 (the follow up visit) (p = 0.011). Although the duration and severity of attacks tended to decrease in the iloprost treated group, these results tended not to reach statistical significance (for severity p = 0.06 at end of treatment, p = 0.09 on day 24). CONCLUSION--Iloprost administered intravenously has been shown to be of benefit in the treatment of the Raynaud's syndrome associated with systemic sclerosis, but this route of administration is inconvenient. This study evaluated the use of iloprost administered orally to patients with Raynaud's syndrome. Patient documented improvement was significantly improved by iloprost. Diary card analysis showed a trend in favour of iloprost, but these results did not reach statistical significance. PMID:7538285

  2. Results of collagen plug occlusion of anal fistula: a multicentre study of 126 patients.

    Science.gov (United States)

    Blom, J; Husberg-Sellberg, B; Lindelius, A; Gustafsson, U-M; Carlens, S; Oppelstrup, H; Bragmark, M; Yin, L; Nyström, P-O

    2014-08-01

    The Biodesign(®) anal fistula plug was introduced as a means of obliterating the fistula tract and promoting healing through biocompatibility. The results demonstrated unexplained variations from good to bad. This report analysed the results of a retrospective multicentre study. All plug procedures performed in four Stockholm hospitals between June 2006 and June 2010 were identified and studied using a common protocol. The outcome after the first plug-insertion procedure was assessed by chart review performed a minimum of 8 months after plug insertion. Cox proportional-hazards models were used to assess the associations of various factors with fistula healing. One-hundred and twenty-six patients (mean age 47 years) were deemed suitable for the plug procedure. Eighty-five per cent of fistulae were cryptoglandular, 64% of patients were male and a mean of 2.9 previous fistulae procedures had been performed. All patients, except four, had an indwelling seton at the time of the plug procedure, which was performed in accordance with previously established principles of day surgery. After a median of 13 months, 30 (24%) fistulae had closed with no discomfort or secretion reported. The outcome in the four hospitals varied from 13% to 33% with similar numbers of patients in each hospital. A success rate of 12% was observed for patients with anterior fistula compared with 32% for those with posterior tracks [hazard ratio (HR) for successful healing = 2.98; 95% CI: 1.01-8.78) and 41% for those with a lateral internal opening (HR = 3.76; 95% CI: 1.03-13.75). Age, sex and number of previous procedures were not associated with healing. Four independent patient groups showed low success rates after the first plug-insertion procedure. Anterior fistulae were much less likely to heal compared with fistulae in other locations. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  3. [Effect of acupuncture on early cerebral palsy infants with parafunctional sitting position: a multi-centre, randomized, control research].

    Science.gov (United States)

    Zhang, Hong-yun; Sun, Qun-ying; Yang, Kun-peng; Chen, Yu-xia; Wang, Qi; Wang, Xi; Liu, Yuan

    2015-02-01

    To study the clinical effect of development theory based acupuncture on early cerebral palsy (CP) infants with parafunctional sitting position. Totally 120 early CP infants were randomly assigned to two groups equally, the treatment group and the control group. All received acupuncture combined with training rehabilitation. Patients in the treatment group adopted acupuncture based on infants development theory, while those in the control group were treated by head acupuncture. Sitting functional points in Gross motor function measure (GMFM) 88 were observed in different groups and infant patients of various types before and after treatment. Root mean square (RMS) signals of sitting correlated muscles (latissimus dorsi, erector spinae, rectus abdominis) were recorded by surface electromyography (sEMG). The effective rate was evaluated by Nimodipine method. Compared with before treatment, sitting functional points were significantly improved in the two groups (Ptreatment, it was higher in the treatment group than in the control group (Ptreatment group after treatment (all Ptreatment group than in the control group (89.29% vs. 77.78%, P<0.05). Infants development theory based acupuncture could effectively elevate dorsi-extensor muscles force, improve sitting position of 8 months to 1 year old CP infants with parafunctional sitting position.

  4. Post-partum weight change patterns in the WHO Multicentre Growth Reference Study.

    Science.gov (United States)

    Onyango, Adelheid W; Nommsen-Rivers, Laurie; Siyam, Amani; Borghi, Elaine; de Onis, Mercedes; Garza, Cutberto; Lartey, Anna; Baerug, Anne; Bhandari, Nita; Dewey, Kathryn G; Araújo, Cora Luiza; Mohamed, Ali Jaffer; Van den Broeck, Jan

    2011-07-01

    The interplay of factors that affect post-partum loss or retention of weight gained during pregnancy is not fully understood. The objective of this paper is to describe patterns of weight change in the six sites of the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) and explore variables that explain variation in weight change within and between sites. Mothers of 1743 breastfed children enrolled in the MGRS had weights measured at days 7, 14, 28 and 42 post-partum, monthly from 2 to 12 months and bimonthly thereafter until 24 months post-partum. Height, maternal age, parity and employment status were recorded and breastfeeding was monitored throughout the follow-up. Weight change patterns varied significantly among sites. Ghanaian and Omani mothers lost little or gained weight post-partum. In Brazil, India, Norway and USA, mothers on average lost weight during the first year followed by stabilization in the second year. Lactation intensity and duration explained little of the variation in weight change patterns. In most sites, obese mothers tended to lose less weight than normal-weight mothers. In Brazil and Oman, primiparous mothers lost about 1 kg more than multiparous mothers in the first 6 months. In India and Ghana, multiparous mothers lost about 0.6 kg more than primiparas in the second 6 months. Culturally defined mother-care practices probably play a role in weight change patterns among lactating women. This hypothesis should stimulate investigation into gestational weight gain and post-partum losses in different ethnocultural contexts.

  5. Role of capsule endoscopy in suspected celiac disease: A European multi-centre study

    Science.gov (United States)

    Luján-Sanchis, Marisol; Pérez-Cuadrado-Robles, Enrique; García-Lledó, Javier; Juanmartiñena Fernández, José-Francisco; Elli, Luca; Jiménez-García, Victoria-Alejandra; Egea-Valenzuela, Juan; Valle-Muñoz, Julio; Carretero-Ribón, Cristina; Fernández-Urién-Sainz, Ignacio; López-Higueras, Antonio; Alonso-Lázaro, Noelia; Sanjuan-Acosta, Mileidis; Sánchez-Ceballos, Francisco; Rosa, Bruno; González-Vázquez, Santiago; Branchi, Federica; Ruano-Díaz, Lucía; Prieto-de-Frías, César; Pons-Beltrán, Vicente; Borque-Barrera, Pilar; González-Suárez, Begoña; Xavier, Sofía; Argüelles-Arias, Federico; Herrerías-Gutiérrez, Juan-Manuel; Pérez-Cuadrado-Martínez, Enrique; Sempere-García-Argüelles, Javier

    2017-01-01

    AIM To analyze the diagnostic yield (DY), therapeutic impact (TI) and safety of capsule endoscopy (CE). METHODS This is a multi-centre, observational, analytical, retrospective study. A total of 163 patients with suspicion of celiac disease (CD) (mean age = 46.4 ± 17.3 years, 68.1% women) who underwent CE from 2003 to 2015 were included. Patients were divided into four groups: seronegative CD with atrophy (Group-I, n = 19), seropositive CD without atrophy (Group-II, n = 39), contraindication to gastroscopy (Group-III, n = 6), seronegative CD without atrophy, but with a compatible context (Group-IV, n = 99). DY, TI and the safety of CE were analysed. RESULTS The overall DY was 54% and the final diagnosis was villous atrophy (n = 65, 39.9%), complicated CD (n = 12, 7.4%) and other enteropathies (n = 11, 6.8%; 8 Crohn’s). DY for groups I to IV was 73.7%, 69.2%, 50% and 44.4%, respectively. Atrophy was located in duodenum in 24 cases (36.9%), diffuse in 19 (29.2%), jejunal in 11 (16.9%), and patchy in 10 cases (15.4%). Factors associated with a greater DY were positive serology (68.3% vs 49.2%, P = 0.034) and older age (P = 0.008). On the other hand, neither sex nor clinical presentation, family background, positive histology or HLA status were associated with DY. CE results changed the therapeutic approach in 71.8% of the cases. Atrophy was associated with a greater TI (92.3% vs 45.3%, P disease. CE is safe procedure with a high degree of concordance with histology and it helps in the differential diagnosis of CD. PMID:28216978

  6. Blunt traumatic aortic injuries of the ascending aorta and aortic arch: a clinical multicentre study.

    Science.gov (United States)

    Mosquera, Victor X; Marini, Milagros; Muñiz, Javier; Gulias, Daniel; Asorey-Veiga, Vanesa; Adrio-Nazar, Belen; Herrera, José M; Pradas-Montilla, Gonzalo; Cuenca, José J

    2013-09-01

    To report the clinical and radiological characteristics, management and outcomes of traumatic ascending aorta and aortic arch injuries. Historic cohort multicentre study including 17 major trauma patients with traumatic aortic injury from January 2000 to January 2011. The most common mechanism of blunt trauma was motor-vehicle crash (47%) followed by motorcycle crash (41%). Patients sustaining traumatic ascending aorta or aortic arch injuries presented a high proportion of myocardial contusion (41%); moderate or greater aortic valve regurgitation (12%); haemopericardium (35%); severe head injuries (65%) and spinal cord injury (23%). The 58.8% of the patients presented a high degree aortic injury (types III and IV). Expected in-hospital mortality was over 50% as defined by mean TRISS 59.7 (SD 38.6) and mean ISS 48.2 (SD 21.6) on admission. Observed in-hospital mortality was 53%. The cause of death was directly related to the ATAI in 45% of cases, head and abdominal injuries being the cause of death in the remaining 55% cases. Long-term survival was 46% at 1 year, 39% at 5 years, and 19% at 10 years. Traumatic aortic injuries of the ascending aorta/arch should be considered in any major thoracic trauma patient presenting cardiac tamponade, aortic valve regurgitation and/or myocardial contusion. These aortic injuries are also associated with a high incidence of neurological injuries, which can be just as lethal as the aortic injury, so treatment priorities should be modulated on an individual basis. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. One year follow-up of the multi-centre European PARTNER transcatheter heart valve study

    Science.gov (United States)

    Lefèvre, Thierry; Kappetein, Ari Pieter; Wolner, Ernst; Nataf, Patrick; Thomas, Martyn; Schächinger, Volker; De Bruyne, Bernard; Eltchaninoff, Hélène; Thielmann, Matthias; Himbert, Dominique; Romano, Mauro; Serruys, Patrick; Wimmer-Greinecker, Gerhard

    2011-01-01

    Background Transcatheter aortic valve implantation (TAVI) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis. Aims PARTNER EU is the first study to evaluate prospectively the procedural and mid-term outcomes of transfemoral (TF) or transapical (TA) implantation of the Edwards SAPIEN® valve involving a multi-disciplinary approach. Methods and results Primary safety endpoints were 30 days and 6 months mortality. Primary efficacy endpoints were haemodynamic and functional improvement at 12 months. One hundred and thirty patients (61 TF, 69 TA), aged 82.1 ± 5.5 years were included. TA patients had higher logistic EuroSCORE (33.8 vs. 25.7%, P = 0.0005) and more peripheral disease (49.3 vs. 16.4%, P< 0.0001). Procedures were aborted in four TA (5.8%) and six TF cases (9.8%). Valve implantation was successful in the remaining patients in 95.4 and 96.4%, respectively. Thirty days and 6 months survival were 81.2 and 58.0% (TA) and 91.8 and 90.2% (TF). In both groups, mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI. In total, 78.1 and 84.8% of patients experienced significant improvement in New York Heart Association (NYHA) class, whereas 73.9 and 72.7% had improved Kansas City Cardiomyopathy Questionnaire (KCCQ) scores in TA and TF cohorts, respectively. Conclusion This first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery. Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort. Optimal patient screening, approach selection, and device refinement may improve outcomes. PMID:21075775

  8. Prevalence of β-thalassemia and other haemoglobinopathies in six cities in India: a multicentre study.

    Science.gov (United States)

    Mohanty, D; Colah, R B; Gorakshakar, A C; Patel, R Z; Master, D C; Mahanta, J; Sharma, S K; Chaudhari, U; Ghosh, M; Das, S; Britt, R P; Singh, S; Ross, C; Jagannathan, L; Kaul, R; Shukla, D K; Muthuswamy, V

    2013-01-01

    The population of India is extremely diverse comprising of more than 3,000 ethnic groups who still follow endogamy. Haemoglobinopathies are the commonest hereditary disorders in India and pose a major health problem. The data on the prevalence of β-thalassemias and other haemoglobinopathies in different caste/ethnic groups of India is scarce. Therefore the present multicentre study was undertaken in six cities of six states of India (Maharashtra, Gujarat, West Bengal, Assam, Karnataka and Punjab) to determine the prevalence of haemoglobinopathies in different caste/ethnic groups using uniform methodology. Fifty-six thousand seven hundred eighty individuals (college students and pregnant women) from different caste/ethnic groups were screened. RBC indices were measured on an automated haematology counter while the percentage of HbA(2), HbF and other abnormal Hb variants were estimated by HPLC on the Variant Hemoglobin Testing System. The overall prevalence of β-thalassemia trait was 2.78 % and varied from 1.48 to 3.64 % in different states, while the prevalence of β-thalassemia trait in 59 ethnic groups varied from 0 to 9.3 %. HbE trait was mainly seen in Dibrugarh in Assam (23.9 %) and Kolkata in West Bengal (3.92 %). In six ethnic groups from Assam, the prevalence of HbE trait varied from 41.1 to 66.7 %. Few subjects with δβ-thalassemia, HPFH, HbS trait, HbD trait, HbE homozygous and HbE β-thalassemia as well as HbS homozygous and HbS-β-thalassemia (India.

  9. Is testis-sparing surgery safe in small testicular masses? Results of a multicentre study

    Science.gov (United States)

    Keske, Murat; Canda, Abdullah Erdem; Yalcin, Serdar; Kilicarslan, Aydan; Kibar, Yusuf; Tuygun, Can; Onder, Evrim; Atmaca, Ali Fuat; Yildirim, Asif; Ozkanli, Sidika Seyma; Kandemir, Olcay; Kargi, Taner; Sar, Mehmet; Tugcu, Volkan; Resorlu, Berkan; Aslan, Yilmaz; Sarikaya, Selcuk; Boylu, Ugur; Cicek, Ali Fuat; Basar, Halil; Tuncel, Altug; Balbay, Mevlana Derya

    2017-01-01

    Introduction Our goal was to evaluate benign and malignant lesions and testicular intraepithelial neoplasia (TIN) in the neighbouring normal-appearing testis tissue in men who underwent radical orchiectomy for testicular mass with a pathologic tumour size of ≤3cm. Methods In this retrospective, multicentre study, data of 252 patients from 11 different institutions were included. Patients were divided into three groups based on tumour size: Group 1 (0–1 cm; n=35), Group 2 (1.1–2cm; n=99), and Group 3 (2.1–3 cm; n=118). Benign lesions and TIN were sought in the neighbouring testicular tissue and compared between groups. Results Mean patient age was 32.3 years. Benign lesions were reported in 54.3%, 33.3%, and 14.4% of Groups 1, 2, and 3, respectively (p0.05 for Groups 2 vs. 3). Multifocality was detected in 8.6%, 4%, and 0% of Groups 1, 2, and 3, respectively (p0.05 for Group 1 vs. Group 2). A tumour cutoff size of 1.5 cm was found to be significant for detecting benign tumour. TIN and multifocality rates were similar in patients with a tumour size of ≤1.5 vs. >1.5 cm (p>0.05). Conclusions Benign lesions and TIN in the neighbouring testis were significantly decreased and multifocality was increased in patients with a tumour mass size of ≤1 cm. Testis-sparing surgery should be performed with caution and a safety rim of normal tissue should also be excised.

  10. Tolerability and efficacy of paliperidone ER compared to olanzapine in the treatment of schizophrenia: A randomized, double-blind, multicentric trial

    Directory of Open Access Journals (Sweden)

    Sandip Shah

    2011-01-01

    Full Text Available Background: Paliperidone is an active metabolite of risperidone and actss through a combination of central dopamine Type 2 (D2 and serotonin Type 2 (5HT2A receptor antagonism. Aim: The present randomized, double-blind, multicentric trial was designed to determine the safety and efficacy of paliperidone extended release (ER compared to olanzapine in the treatment of acute schizophrenia. Materials and Methods: A total of 214 patients with diagnosis of schizophrenia were randomized to paliperidone ER (n=109 and olanzapine (n=106 treatment groups. Totally 206 patients were evaluated for efficacy parameters using Positive and negative syndrome scale (PANSS score and Clinical Global Impression-severity of illness (CGI-S and Clinical Global Impression-improvement of illness (CGI-I scales. Safety was assessed by treatment-emergent adverse events and movement disorders. Results: All patients showed significant reduction in PANSS scores at the end of treatment. However, the results were comparable and there was no significant difference at the end of the trial between paliperidone ER group and olanzapine group. Both the treatment groups showed decrease in the severity of illness and improvement in symptomatology. The most common adverse events reported in paliperidone ER versus olanzapine group were Extra Pyramidal Syndrome (EPS (13.7% vs. 15.6%, headache (12.7% vs. 8.9%, increased appetite (8.8% vs. 10.0% and drowsiness (4.9% vs. 303%. There was no clinically relevant difference in change from baseline to the end of the trial in abnormal involuntary movement scale (AIMS and barnes akathisia rating scale (BARS total scores between both the groups. Conclusion: Paliperidone ER is effective in controlling schizophrenic symptoms as well as exhibits comparable tolerability profile. Thus, paliperidone ER has the potential to be a useful new treatment option for patients with schizophrenia.

  11. Recombinant streptokinase suppositories in the treatment of acute haemorrhoidal disease. Multicentre randomized double-blind placebo-controlled trial (THERESA-2).

    Science.gov (United States)

    Hernández-Bernal, F; Valenzuela-Silva, C M; Quintero-Tabío, L; Castellanos-Sierra, G; Monterrey-Cao, D; Aguilera-Barreto, A; López-Saura, P

    2013-11-01

    A four-arm multicentre randomized double-blind placebo-controlled trial was undertaken to assess the effect and safety of suppositories containing recombinant streptokinase (rSK) at two dose levels (100,000 IU and 200,000 IU) with sodium salicylate (SS) compared with placebo and SS for the treatment of acute haemorrhoidal disease. Patients with acute symptoms of haemorrhoids were randomized to four treatment groups: (I) placebo, (II) SS, (III) SS + rSK 100,000 IU and (IV) SS + rSK 200,000 IU per suppository. Inpatient treatment was by four suppositories given every 6 h to discharge at 24 h. Evaluations were made at the time of discharge (24 h) and at 3, 5 and 20 days later. The main end-point was the degree of relief of pain, oedema and reduction in the size of the lesion by 90% on day 5. Adverse events and the occurrence of anti-SK antibodies were also determined. Eighty patients were included. Respective response rates in the four groups were 16%, 30%, 25% and 52%. In the last group there was a significant difference (36.8%) compared with control (95% CI 7.0-58.4%). The time to response was significantly shorter (median 5 days) in the 200,000 IU rSK group with respect to the others. There were no adverse events attributable to the treatment. No increase in anti-SK antibodies was detected 20 days after treatment. Suppositories with 200,000 IU rSK showed a significant improvement in symptoms of acute haemorrhoids, with an adequate safety profile. Colorectal Disease © 2013 The Association of Coloproctology of Great Britain and Ireland.

  12. Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial.

    Science.gov (United States)

    Kim, Joo-Hee; Jung, Hyun Jung; Kim, Tae-Hun; Lee, Seunghoon; Kim, Jung-Eun; Kang, Kyung-Won; Jung, So-Young; Kim, Ae-Ran; Park, Hyo-Ju; Shin, Mi-Suk; Shin, Kyung-Min; Jung, Hee-Jung; Lee, Seung-Deok; Hong, Kwon-Eui; Choi, Sun-Mi

    2013-09-22

    Hypertension, a worldwide public health problem, is a major risk factor for cardiovascular and kidney disease, and the medical and economic burden of hypertension is increasing. Auricular acupuncture has been used to treat various diseases, including hypertension. Several studies have shown that auricular acupuncture treatment decreases blood pressure in patients with hypertension; however, the scientific evidence is still insufficient. Therefore, we aimed to perform a randomised controlled clinical trial in patients with prehypertension and stage 1 hypertension to evaluate the effect and safety of auricular acupuncture. This on-going study is a two parallel arm, assessor-blinded, randomised controlled trial. Sixty participants with prehypertension and stage 1 hypertension will be recruited and randomly allocated into two groups in a 1:1 ratio. Participants in the auricular acupuncture group will receive auricular acupuncture treatment two times per week for 4 weeks. Participants in the usual care group will not receive any acupuncture treatment during the study period. All participants in both groups will be provided with verbal and written educational materials regarding the dietary and physical activity habits for controlling high blood pressure, and they will self-manage their lifestyle, including diet and exercise, during the study. The primary outcome is the 24-h average systolic and diastolic blood pressure, as measured with an ambulatory monitor. The secondary outcomes are the mean change in the average systolic and diastolic blood pressure during day- and night-time, the circadian rhythm of blood pressure, the mean arterial pressure, the change in blood pressure before and after auricular acupuncture treatment, the EuroQOL-5D (EQ-5D), heart rate variability (HRV), body mass index (BMI) and laboratory examination, including lipid profile and high sensitivity C-reactive protein (hs-CRP). Safety will be assessed at every visit. This pilot multicentre

  13. First episode psychosis and outcome : Findings from a swedish multi-centre study

    OpenAIRE

    Mattsson, Maria

    2007-01-01

    The Parachute Project was a Swedish multi-centre project that included 175 First Episode Psychosis patients who were followed over five years. The aim was to provide need adapted care with low medication and based on out-patient support in order to positively affect long-term outcome. One historical and one prospective treatment-as-usual group provided comparison follow-up data. The aim of this thesis is to describe outcome from various perspectives in FEP patients. Stud...

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

    DEFF Research Database (Denmark)

    Haaverstad, Rune; Vitale, Nicola; Karevold, Asbjørn

    2006-01-01

    OBJECTIVE: The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis. METHODS: From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received...... echocardiography. CONCLUSIONS: Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use....

  15. Chasing the effects of Pre-analytical Confounders - a Multicentre Study on CSF-AD biomarkers

    Directory of Open Access Journals (Sweden)

    Maria Joao Leitao

    2015-07-01

    Full Text Available Core cerebrospinal fluid (CSF biomarkers-Aβ42, Tau and pTau–have been recently incorporated in the revised criteria for Alzheimer’s disease (AD. However, their widespread clinical application lacks standardization. Pre-analytical sample handling and storage play an important role in the reliable measurement of these biomarkers across laboratories. In this study, we aim to surpass the efforts from previous studies, by employing a multicentre approach to assess the impact of less studied CSF pre-analytical confounders in AD-biomarkers quantification. Four different centres participated in this study and followed the same established protocol. CSF samples were analysed for three biomarkers (Aβ42, Tau and pTau and tested for different spinning conditions (temperature: Room temperature (RT vs. 4oC; speed: 500g vs. 2000g vs. 3000g, storage volume variations (25%, 50% and 75% of tube total volume as well as freezing-thaw cycles (up to 5 cyles. The influence of sample routine parameters, inter-centre variability and relative value of each biomarker (reported as normal/abnormal, was analysed. Centrifugation conditions did not influence biomarkers levels, except for samples with a high CSF total protein content, where either non centrifugation or centrifugation at RT, compared to 4ºC, led to higher Aβ42 levels. Reducing CSF storage volume from 75% to 50% of total tube capacity, decreased Aβ42 concentration (within analytical CV of the assay, whereas no change in Tau or pTau was observed. Moreover, the concentration of Tau and pTau appears to be stable up to 5 freeze-thaw cycles, whereas Aβ42 levels decrease if CSF is freeze-thawed more than 3 times. This systematic study reinforces the need for CSF centrifugation at 4ºC prior to storage and highlights the influence of storage conditions in Aβ42 levels. This study contributes to the establishment of harmonized standard operating procedures that will help reducing inter-lab variability of CSF

  16. Some case studies of random walks in dynamic random environments

    NARCIS (Netherlands)

    Soares dos Santos, Renato

    2012-01-01

    This thesis is dedicated to the study of random walks in dynamic random environments. These are models for the motion of a tracer particle in a disordered medium, which is called a static random environment if it stays constant in time, or dynamic otherwise. The evolution of the random walk is defi

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

    DEFF Research Database (Denmark)

    Jacobsen, Søren; Petersen, J; Ullman, S;

    1998-01-01

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

  18. Early Lupus Project - A multicentre Italian study on systemic lupus erythematosus of recent onset.

    Science.gov (United States)

    Sebastiani, G D; Prevete, I; Piga, M; Iuliano, A; Bettio, S; Bortoluzzi, A; Coladonato, L; Tani, C; Spinelli, F R; Fineschi, I; Mathieu, A

    2015-10-01

    Systemic lupus erythematosus (SLE) is an autoimmune disease with a high degree of variability at onset that is problematic for a correct and prompt diagnosis. We undertook this project with the purpose of collecting an inception cohort of Italian patients with recent-onset SLE, in order to obtain information on the main clinical and serological characteristics at the beginning of the disease. In this first report we describe the characteristics of this cohort at study entry. All patients with a diagnosis of SLE (1997 ACR criteria) and a disease duration less than 12 months were consecutively enrolled between 1 January 2012 and 31 December 2013 in a multicentre prospective study. Information on clinical and serological characteristics at study entry and then every six months was collected into a specific electronic database. Statistical analysis was performed by means of the Openstat program. Among 122 patients enrolled (103 F) 94.3% were Caucasians. Mean age (SD) of patients at study entry was 37.3 (14.3) years, mean age at disease onset was 34.8 (14.3) years, mean age at diagnosis was 36.9 (14.3) years, and mean disease duration was 2.9 (3.9) months. The frequency of the manifestations included in the 1997 ACR criteria was as follows: ANA 97.5%, immunologic disorders (anti-dsDNA, anti-Sm, antiphospholipid antibodies) 85.2%, arthritis 61.8%, haematologic disorders 55.7%, malar rash 31.1%, photosensitivity 29.5%, serositis 27%, renal disorders 27%, oral/nasal ulcers 11.5%, neurologic disorders 8.2%, and discoid rash 5.7%. The cumulative frequency of mucocutaneous symptoms was 77.8%. At enrolment, autoantibody frequency was: ANA 100%, anti-dsDNA 83.6%, anti-SSA 28%, anticardiolipin 24.5%, anti-nRNP 20.4%, anti-beta2GPI 17.2%, lupus anticoagulant 16.3%, anti-Sm 16%, and anti-SSB 13.1%. In this paper we describe the main clinical and serological characteristics of an Italian inception cohort of patients with recent-onset SLE. At disease onset, mucocutaneous

  19. MD-Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial.

    Science.gov (United States)

    Nimri, Revital; Bratina, Natasa; Kordonouri, Olga; Avbelj Stefanija, Magdalena; Fath, Maryam; Biester, Torben; Muller, Ido; Atlas, Eran; Miller, Shahar; Fogel, Aviel; Phillip, Moshe; Danne, Thomas; Battelino, Tadej

    2017-04-01

    To evaluate the safety, efficacy and need for remote monitoring of the MD-Logic closed-loop system during short-term overnight use at home. Seventy-five patients (38 male; aged 10-54 years; average A1c, 7.8% ± 0.7%, 61.8 ± 7.2 mmol/mol) were enrolled from 3 clinical sites. Patients were randomly assigned to participate in 2 overnight crossover periods, each including 4 consecutive nights, 1 under closed-loop control and 1 under sensor-augmented pump (SAP) therapy in the patient's home. Both study arms were supervised using a remote-monitoring system in a blinded manner. Primary endpoints were time spent with glucose levels below 70 mg/dL and percentage of nights in which mean overnight glucose levels were within 90 to 140 mg/dL. The median [interquartile range] percentage of time spent in hypoglycaemia was significantly lower on nights when MD-Logic was used, compared to SAP therapy (2.07 [0, 4.78] and 2.6 [0, 10.34], respectively; P = .004) and the percentage of individual nights with a mean overnight glucose level in target was significantly greater (75 [42, 75] and 50 [25,75], respectively; P = .008). The time spent in target range was increased by a median of 28% (P = .001), with the same amount of insulin (10.69 [7.28, 13.94] and 10.41[6.9, 14.07], respectively; P = .087). The remote monitoring triggered calls for hypoglycaemia at twice the rate during SAP therapy compared to closed-loop control (62 and 29, respectively; P = .002). The MD-Logic system demonstrated a safe and efficient profile during overnight use by children, adolescents and adults with type 1 diabetes and, therefore, provides an effective means of mitigating the risk of nocturnal hypoglycaemia. © 2016 John Wiley & Sons Ltd.

  20. Chikungunya infection in India: results of a prospective hospital based multi-centric study.

    Directory of Open Access Journals (Sweden)

    Pratima Ray

    Full Text Available BACKGROUND: Chikungunya (CHIKV has recently seen a re-emergence in India with high morbidity. However, the epidemiology and disease burden remain largely undetermined. A prospective multi-centric study was conducted to evaluate clinical, epidemiological and virological features of chikugunya infection in patients with acute febrile illness from various geographical regions of India. METHODS AND FINDINGS: A total of 540 patients with fever of up to 7 days duration were enrolled at Karnataka Institute of Medical Sciences (KIMS, Karnataka (South; Sawai Man Singh Medical College (SMS Rajasthan (West, and All India Institute of Medical Sciences (AIIMS New Delhi (North from June 2008 to May 2009. Serum specimens were screened for chikungunya infection concurrently through RT-PCR and serology (IgM. Phylogenetic analysis was performed using Bioedit and Mega2 programs. Chikungunya infection was detected in 25.37% patients by RT-PCR and/or IgM-ELISA. Highest cases were detected in south (49.36% followed by west (16.28% and north (0.56% India. A difference in proportion of positives by RT-PCR/ELISA with regard to duration of fever was observed (p<0.05. Rashes, joint pain/swelling, abdominal pain and vomiting was frequently observed among chikungunya confirmed cases (p<0.05. Adults were affected more than children. Anti-CHIK antibodies (IgM were detected for more than 60 days of fever onset. Phylogenetic analysis based on E1 gene from KIMS patients (n = 15 revealed ∼99% homology clustering with Central/East African genotype. An amino acid change from lysine to glutamine at position 132 of E1 gene was frequently observed among strains infecting children. CONCLUSIONS: The study documented re-emergence of chikungunya in high frequencies and severe morbidity in south and west India but rare in north. The study emphasizes the need for continuous surveillance for disease burden using multiple diagnostic tests and also warrants the need for an appropriate

  1. Optimisation of metabolic criteria in the prognostic assessment in patients with lymphoma. A multicentre study.

    Science.gov (United States)

    Del Puig Cózar-Santiago, M; García-Garzón, J R; Moragas-Freixa, M; Soler-Peter, M; Bassa Massanas, P; Sánchez-Delgado, M; Sanchez-Jurado, R; Aguilar-Barrios, J E; Sanz-Llorens, R; Ferrer-Rebolleda, J

    To compare sensitivity, specificity and predictive value of Deauville score (DS) vs. ΔSUVmax in interim-treatment PET (iPET) and end-treatment PET (ePET), in patients with diffuse large B cell lymphoma (DLBCL), Hodgkin lymphoma (HL), and follicular lymphoma (FL). Retrospective longitudinal multicentre study including 138 patients (46 DLBCL, 46 HL, 46 FL), on whom 3 (18)F-FDG PET/CT were performed: baseline, iPET, and ePET. Visual (DS) and semi-quantitative (ΔSUVmax) parameters were determined for iPET and ePET. Predictive value was determined in relation to disease-free interval. Statistical analysis. iPET for DLBCL, HL, and FL: 1) sensitivity of DS: 76.92/83.33/61.53%; specificity: 78.78/85/81.81%; 2) sensitivity of ΔSUVmax: 53.84/83.33/61.53%; specificity: 87.87/87.50/78.78%. ePET for DLBCL, HL and FL: 1) sensitivity of DS: 61.53/83.33/69.23%; specificity: 90.90/85/87.87%; 2) sensitivity of ΔSUVmax: 69.23/83.33/69.23%; specificity: 90.90/87.50/84.84%. Predictive assessment. iPET study: in DLBCL, DS resulted in 10.3% recurrence of negative iPET, and 17.1% in ΔSUVmax at disease-free interval; in HL, both parameters showed a 2.8% recurrence of negative iPET; in FL, DS resulted in 15.6% recurrence of negative iPET, and 16.1% in ΔSUVmax, with no statistical significance. ePET study: in DLBCL, DS resulted in 14.3% recurrence of negative ePET, and 11.8% in ΔSUVmax at disease-free interval; in HL and FL, both methods showed 2.8 and 12.5% recurrence in negative ePET, respectively. DS and ΔSUVmax did not show significant differences in DLBCL, HL and FL. Their predictive value also did not show significant differences in HL and FL. In DLBCL, DS was higher in iPET, and ΔSUVmax in ePET. Copyright © 2017 Elsevier España, S.L.U. y SEMNIM. All rights reserved.

  2. IgA anti-actin antibodies ELISA in coeliac disease: a multicentre study.

    Science.gov (United States)

    Carroccio, A; Brusca, I; Iacono, G; Alessio, M G; Sonzogni, A; Di Prima, L; Barrale, M; Ottomano, C; Ambrosiano, G; Teresi, S; D'Angelo, A; Pirrone, G; Cefalù, B; Scalici, C; La Chiusa, S M

    2007-09-01

    Previous studies have demonstrated that serum anti-actin antibodies are a reliable marker of intestinal damage severity in coeliac disease. To validate in a multicentre study the clinical usefulness of serum IgA anti-actin antibody ELISA and its possible use in monitoring intestinal mucosa lesions during gluten-free diet. Four centres recruited 205 newly diagnosed coeliac disease patients with villous atrophy, 80 healthy controls and 81 "disease" controls. Twelve coeliac disease patients on gluten-free diet but with persistent symptoms underwent serum IgA anti-actin antibody assay and intestinal histology evaluation. IgA anti-actin antibody ELISA was performed with a commercial kit. All coeliac disease patients underwent intestinal histology study. IgA anti-actin antibodies showed a sensitivity of 80% and a specificity of 85% in the diagnosis of coeliac disease patients with villous atrophy. The area under the receiving operator curve for anti-actin antibodies was 0.873 [95% C.I. 0.805-0.899]. Serum anti-actin antibodies values were significantly higher in coeliac disease patients than in healthy or "disease" controls (P<0.0001). Serum anti-actin antibodies were positive in 41 of the 60 coeliac disease patients with mild intestinal histology lesions (69%) and in 123 of the 145 with severe lesions (85.3%) (P<0.05). There was a significant inverse correlation between anti-actin antibody values and the villi/crypts ratio (r=-0.423; P<0.0001). In the 12 coeliac disease patients on gluten-free diet who underwent re-evaluation as they were persistently symptomatic, intestinal histology showed three cases with persistent villous atrophy: all of these were positive for serum anti-actin antibodies ELISA, whereas both serum anti-tTG and EmAs were negative. The other nine patients showed normal intestinal villi and were negative for serum anti-actin antibodies. Anti-actin antibodies are a reliable marker of severe intestinal mucosa damage in coeliac disease patients and a

  3. Recruitment and retention in a multicentre randomised controlled trial in Bell's palsy: A case study

    Directory of Open Access Journals (Sweden)

    Daly Fergus

    2007-03-01

    Full Text Available Abstract Background It is notoriously difficult to recruit patients to randomised controlled trials in primary care. This is particularly true when the disease process under investigation occurs relatively infrequently and must be investigated during a brief time window. Bell's palsy, an acute unilateral paralysis of the facial nerve is just such a relatively rare condition. In this case study we describe the organisational issues presented in setting up a large randomised controlled trial of the management of Bell's palsy across primary and secondary care in Scotland and how we managed to successfully recruit and retain patients presenting in the community. Methods Where possible we used existing evidence on recruitment strategies to maximise recruitment and retention. We consider that the key issues in the success of this study were; the fact that the research was seen as clinically important by the clinicians who had initial responsibility for recruitment; employing an experienced trial co-ordinator and dedicated researchers willing to recruit participants seven days per week and to visit them at home at a time convenient to them, hence reducing missed patients and ensuring they were retained in the study; national visibility and repeated publicity at a local level delivered by locally based principal investigators well known to their primary care community; encouraging recruitment by payment to practices and reducing the workload of the referring doctors by providing immediate access to specialist care; good collaboration between primary and secondary care and basing local investigators in the otolarnygology trial centres Results Although the recruitment rate did not meet our initial expectations, enhanced retention meant that we exceeded our planned target of recruiting 550 patients within the planned time-scale. Conclusion While difficult, recruitment to and retention within multi-centre trials from primary care can be successfully

  4. Posttraumatic stress among women after induced abortion: a Swedish multi-centre cohort study

    Science.gov (United States)

    2013-01-01

    Background Induced abortion is a common medical intervention. Whether psychological sequelae might follow induced abortion has long been a subject of concern among researchers and little is known about the relationship between posttraumatic stress disorder (PTSD) and induced abortion. Thus, the aim of the study was to assess the prevalence of PTSD and posttraumatic stress symptoms (PTSS) before and at three and six months after induced abortion, and to describe the characteristics of the women who developed PTSD or PTSS after the abortion. Methods This multi-centre cohort study included six departments of Obstetrics and Gynaecology in Sweden. The study included 1457 women who requested an induced abortion, among whom 742 women responded at the three-month follow-up and 641 women at the six-month follow-up. The Screen Questionnaire-Posttraumatic Stress Disorder (SQ-PTSD) was used for research diagnoses of PTSD and PTSS, and anxiety and depressive symptoms were evaluated by the Hospital Anxiety and Depression Scale (HADS). Measurements were made at the first visit and at three and six months after the abortion. The 95% confidence intervals for the prevalence of lifetime or ongoing PTSD and PTSS were calculated using the normal approximation. The chi-square test and the Student’s t-test were used to compare data between groups. Results The prevalence of ongoing PTSD and PTSS before the abortion was 4.3% and 23.5%, respectively, concomitant with high levels of anxiety and depression. At three months the corresponding rates were 2.0% and 4.6%, at six months 1.9% and 6.1%, respectively. Dropouts had higher rates of PTSD and PTSS. Fifty-one women developed PTSD or PTSS during the observation period. They were young, less well educated, needed counselling, and had high levels of anxiety and depressive symptoms. During the observation period 57 women had trauma experiences, among whom 11 developed PTSD or PTSS and reported a traumatic experience in relation to the

  5. Clinical intervals and diagnostic characteristics in a cohort of prostate cancer patients in Spain: a multicentre observational study.

    Science.gov (United States)

    Bonfill, Xavier; Martinez-Zapata, María José; Vernooij, Robin W M; Sánchez, María José; Suárez-Varela, María Morales; de la Cruz, Javier; Emparanza, José Ignacio; Ferrer, Montserrat; Pijoán, José Ignacio; Ramos-Goñi, Juan M; Palou, Joan; Schmidt, Stefanie; Abraira, Víctor; Zamora, Javier

    2015-07-02

    Little is known about the healthcare process for patients with prostate cancer, mainly because hospital-based data are not routinely published. The main objective of this study was to determine the clinical characteristics of prostate cancer patients, the, diagnostic process and the factors that might influence intervals from consultation to diagnosis and from diagnosis to treatment. We conducted a multicentre, cohort study in seven hospitals in Spain. Patients' characteristics and diagnostic and therapeutic variables were obtained from hospital records and patients' structured interviews from October 2010 to September 2011. We used a multilevel logistic regression model to examine the association between patient care intervals and various variables influencing these intervals (age, BMI, educational level, ECOG, first specialist consultation, tumour stage, PSA, Gleason score, and presence of symptoms) and calculated the odds ratio (OR) and the interquartile range (IQR). To estimate the random inter-hospital variability, we used the median odds ratio (MOR). 470 patients with prostate cancer were included. Mean age was 67.8 (SD: 7.6) years and 75.4% were physically active. Tumour size was classified as T1 in 41.0% and as T2 in 40% of patients, their median Gleason score was 6.0 (IQR:1.0), and 36.1% had low risk cancer according to the D'Amico classification. The median interval between first consultation and diagnosis was 89 days (IQR:123.5) with no statistically significant variability between centres. Presence of symptoms was associated with a significantly longer interval between first consultation and diagnosis than no symptoms (OR:1.93, 95%CI 1.29-2.89). The median time between diagnosis and first treatment (therapeutic interval) was 75.0 days (IQR:78.0) and significant variability between centres was found (MOR:2.16, 95%CI 1.45-4.87). This interval was shorter in patients with a high PSA value (p = 0.012) and a high Gleason score (p = 0.026). Most

  6. Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial.

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    Raquel González

    2014-09-01

    Full Text Available Intermittent preventive treatment in pregnancy (IPTp with sulfadoxine-pyrimethamine (SP is recommended by WHO to prevent malaria in African pregnant women. The spread of SP parasite resistance has raised concerns regarding long-term use for IPT. Mefloquine (MQ is the most promising of available alternatives to SP based on safety profile, long half-life, and high efficacy in Africa. We evaluated the safety and efficacy of MQ for IPTp compared to those of SP in HIV-negative women.A total of 4,749 pregnant women were enrolled in an open-label randomized clinical trial conducted in Benin, Gabon, Mozambique, and Tanzania comparing two-dose MQ or SP for IPTp and MQ tolerability of two different regimens. The study arms were: (1 SP, (2 single dose MQ (15 mg/kg, and (3 split-dose MQ in the context of long lasting insecticide treated nets. There was no difference on low birth weight prevalence (primary study outcome between groups (360/2,778 [13.0%] for MQ group and 177/1,398 (12.7% for SP group; risk ratio [RR], 1.02 (95% CI 0.86-1.22; p=0.80 in the ITT analysis. Women receiving MQ had reduced risks of parasitemia (63/1,372 [4.6%] in the SP group and 88/2,737 [3.2%] in the MQ group; RR, 0.70 [95% CI 0.51-0.96]; p=0.03 and anemia at delivery (609/1,380 [44.1%] in the SP group and 1,110/2743 [40.5%] in the MQ group; RR, 0.92 [95% CI 0.85-0.99]; p=0.03, and reduced incidence of clinical malaria (96/551.8 malaria episodes person/year [PYAR] in the SP group and 130/1,103.2 episodes PYAR in the MQ group; RR, 0.67 [95% CI 0.52-0.88]; p=0.004 and all-cause outpatient attendances during pregnancy (850/557.8 outpatients visits PYAR in the SP group and 1,480/1,110.1 visits PYAR in the MQ group; RR, 0.86 [0.78-0.95]; p=0.003. There were no differences in the prevalence of placental infection and adverse pregnancy outcomes between groups. Tolerability was poorer in the two MQ groups compared to SP. The most frequently reported related adverse events were dizziness

  7. Brazilian multicentre study on preterm birth (EMIP: prevalence and factors associated with spontaneous preterm birth.

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    Renato Passini

    Full Text Available BACKGROUND: Preterm birth rate is increasing and is currently a worldwide concern. The purpose of this study was to estimate the prevalence of preterm birth in a sample of health facilities in Brazil and to identify the main risk factors associated with spontaneous preterm births. METHODS AND FINDINGS: This was a multicentre cross sectional study on preterm births in 20 referral obstetric hospitals with a case-control component to identify factors associated with spontaneous preterm birth. Surveillance was implemented at all centres to identify preterm births. For eligible consenting women, data were collected through a post-delivery questionnaire completed with information from all mother-newborn medical records until death or discharge or at a maximum of 60 days post-delivery, whichever came first. The risk of spontaneous preterm birth was estimated with OR and 95%CI for several predictors. A non-conditional logistic regression analysis was then performed to identify independently associated factors. The overall prevalence of preterm birth was 12.3%. Among them, 64.6% were spontaneous and 35.4% therapeutic. In the case-control component, 2,682 spontaneous preterm births were compared to a sample of 1,146 term births. Multivariate analyses identified the following as risk factors for spontaneous preterm birth among women with at least one previous birth: a previous preterm birth (ORadj = 3.19, 2.30-4.43, multiple pregnancy (ORadj = 29.06, 8.43-100.2, cervical insufficiency (ORadj = 2.93, 1.07-8.05, foetal malformation (ORadj = 2.63, 1.43-4.85, polyhydramnios (ORadj = 2.30, 1.17-4.54, vaginal bleeding (ORadj = 2.16, 1.50-3.11, and previous abortion (ORadj = 1.39, 1.08-1.78. High BMI (ORadj = 0.94, 0.91-0.97 and weight gain during gestation (ORadj = 0.92, 0.89-0.95 were found to be protective factors. CONCLUSIONS: The preterm birth rate in these health facilities in Brazil is high and spontaneous preterm births

  8. Acute ischaemic brain lesions in intracerebral haemorrhage: multicentre cross-sectional magnetic resonance imaging study.

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    Gregoire, Simone M; Charidimou, Andreas; Gadapa, Naveen; Dolan, Eamon; Antoun, Nagui; Peeters, Andre; Vandermeeren, Yves; Laloux, Patrice; Baron, Jean-Claude; Jäger, Hans R; Werring, David J

    2011-08-01

    Subclinical acute ischaemic lesions on brain magnetic resonance imaging have recently been described in spontaneous intracerebral haemorrhage, and may be important to understand pathophysiology and guide treatment. The underlying mechanisms are uncertain. We tested the hypothesis that ischaemic lesions are related to magnetic resonance imaging markers of the severity and type of small-vessel disease (hypertensive arteriopathy or cerebral amyloid angiopathy) in a multicentre, cross-sectional study. We studied consecutive patients with intracerebral haemorrhage from four specialist stroke centres, and age-matched stroke service referrals without intracerebral haemorrhage. Acute ischaemic lesions were assessed on magnetic resonance imaging (imaging. White matter changes and cerebral microbleeds were rated with validated scales. We investigated associations between diffusion-weighted imaging lesions, clinical and radiological characteristics. We included 114 patients with intracerebral haemorrhage (39 with clinically probable cerebral amyloid angiopathy) and 47 age-matched controls. The prevalence of diffusion-weighted imaging lesions was 9/39 (23%) in probable cerebral amyloid angiopathy-related intracerebral haemorrhage versus 6/75 (8%) in the remaining patients with intracerebral haemorrhage (P = 0.024); no diffusion-weighted imaging lesions were found in controls. Diffusion-weighted imaging lesions were mainly cortical and were associated with mean white matter change score (odds ratio 1.14 per unit increase, 95% confidence interval 1.02-1.28, P = 0.024) and the presence of strictly lobar cerebral microbleeds (odds ratio 3.85, 95% confidence interval 1.15-12.93, P = 0.029). Acute, subclinical ischaemic brain lesions are frequent but previously underestimated after intracerebral haemorrhage, and are three times more common in cerebral amyloid angiopathy-related intracerebral haemorrhage than in other intracerebral haemorrhage types. Ischaemic brain lesions are

  9. 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

  10. Musculoskeletal trauma and all-cause mortality in India: a multicentre prospective cohort study.

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    Foote, Clary Jefferson; Mundi, Raman; Sancheti, Parag; Gopalan, Hitesh; Kotwal, Prakash; Shetty, Vijay; Dhillon, Mandeep; Devereaux, Philip; Thabane, Lehana; Aleem, Ilyas; Ivers, Rebecca Q; Bhandari, Mohit

    2015-04-27

    There is little data in low-income and middle-income countries (LMICs) quantifying the burden of fractures and describing current practices. The aim of the study was describe the severity of musculoskeletal injuries in LMICS and identify modifiable factors that predict subsequent early all-cause mortality. We did a multicentre, prospective, observational study of patients who presented to 14 hospitals across India for musculoskeletal trauma (fractures or dislocations). Patients were recruited during an 8-week period, between November, 2011, and June, 2012, and were followed for 30-days or hospital discharge, whichever occurred first. Primary outcome was all-cause mortality with secondary outcomes of reoperation and infection. Logistic regression analyses were conducted to identify factors associated with all-cause mortality. We enrolled 4822 patients, but restricted analyses to 4612 (96%) patients who had complete follow-up. The majority (56·2% younger than 40 years old) of trauma patients were young (mean age 40·9 years [SD 16·9]) and 3148 (68%) were men. 2344 (518%) patients sustained trauma as a result of a road traffic accident. The most common musculoskeletal injury was a fracture (4514 [98%]) and 707 patients (15%) incurred an open fracture. Less than a third of musculoskeletal trauma patients (1374 [29%]) were transported to hospital by ambulance, and one in six patients (18%) arrived at the hospital later than 24 h after sustaining their injury. Over a third (239 [35%] of 707) of open fractures were definitively stabilised later than 24 h. 30-day mortality was 1·7% (95% CI 1·4-2·2) for all patients and 2·1% (95% CI 1·5-2·7) among road traffic victims (p=0·005). Musculoskeletal trauma severity including the number of fractures (3·1 [95% CI 2·4-3·9]) and presence of an open fracture (2·1 [95% CI 1·2-3·4]) significantly increased the odds of all-cause mortality. Musculoskeletal trauma severity, particularly road related, is a key predictor of

  11. Patient’s satisfaction after 2-piece inflatable penile prosthesis implantation: An Italian multicentric study

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    Giorgio Gentile

    2016-03-01

    Full Text Available Introduction: Penile prosthesis implant represents a valuable solution for pts with severe erectile dysfunction (ED, non-responders to medical management. The aim of our study was to evaluate the satisfaction of patients (pts after 2-pieces inflatable penile prosthesis (IPP. Aim of the study: to evaluate safety, reliability and post-operative patient’s satisfaction after implantation of two-pieces IPP. Materials and Methods: This retrospective multicentric analysis concerns a group of 42 patients undergone 2-pieces IPP implantation from November 2005 to November 2013, in four Centers of proven experience. As a first step, a detailed review of all clinical reports was performed. Secondly, every patient was asked to fill the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS specifically modified, in order to assess their own satisfaction after surgery and, its impact on patient’s quality of sexual life. Results: 42 pts were evaluated (AMS-Ambicor: 28; Coloplast- Excell: 14; mean age, at time of operation: 60,7 years; mean follow up: 27,6 months; etiology of ED: vascular 23,8%, diabetes 19%, La Peyronie D. 7,1%, consequence of radical prostatectomy 31%, consequence of other pelvic surgery 11,9%, spinal trauma 7%. Mean operative time: 117 ± 58 min, mean postoperative hospital stay 3 ± 1,6 days. Post operative short-term complications: 4 pts (9,5%. Post operative long-term complications: 4 pts (9,5%. Long-term functional results (Questionnaire: 71% of pts (30 reported regular use of the prosthesis, at least 1 time/week, the satisfaction was good in 42% of pts (18, quite good in 33,3% (14, quite bad in 2,4% (1, very bad in 7,1% (3, 6 pts (14,4% didn’t answer. Conclusions: 2 pieces IPP appears to be associated with a low complication rate and good satisfaction of pts especially in the elderly. It also assures satisfactory rates of aesthetics and functional results.

  12. Job satisfaction and turnover intention among Iraqi doctors--a descriptive cross-sectional multicentre study.

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    Ali Jadoo, Saad Ahmed; Aljunid, Syed Mohamed; Dastan, Ilker; Tawfeeq, Ruqiya Subhi; Mustafa, Mustafa Ali; Ganasegeran, Kurubaran; AlDubai, Sami Abdo Radman

    2015-04-19

    During the last two decades, the Iraqi human resources for health was exposed to an unprecedented turnover of trained and experienced medical professionals. This study aimed to explore prominent factors affecting turnover intentions among Iraqi doctors. A descriptive cross-sectional multicentre study was carried out among 576 doctors across 20 hospitals in Iraq using multistage sampling technique. Participants completed a self-administered questionnaire, which included socio-demographic information, work characteristics, the 10-item Warr-Cook-Wall job satisfaction scale, and one question on turnover intention. Descriptive and bivariate and multiple logistic regression analyses were conducted to identify significant factors affecting turnover intentions. More than one half of Iraqi doctors (55.2%) were actively seeking alternative employment. Factors associated with turnover intentions among doctors were low job satisfaction score (odds ratio (OR) = 0.97; 95% confidence interval (CI): 0.95, 0.99), aged 40 years old or less (OR = 2.9; 95% CI: 1.74, 4.75), being male (OR = 4.2; 95% CI: 2.54, 7.03), being single (OR = 5.0; 95% CI: 2.61, 9.75), being threatened (OR = 3.5; 95% CI: 1.80, 6.69), internally displaced (OR = 3.1; 95% CI: 1.43, 6.57), having a perception of unsafe medical practice (OR = 4.1; 95% CI: 1.86, 9.21), working more than 40 h per week, (OR = 2.3; 95% CI: 1.27, 4.03), disagreement with the way manager handles staff (OR = 2.2; 95% CI: 1.19, 4.03), being non-specialist, (OR = 3.9, 95% CI: 2.08, 7.13), and being employed in the government sector only (OR = 2.0; 95% CI: 1.09, 3.82). The high-turnover intention among Iraqi doctors is significantly associated with working and security conditions. An urgent and effective strategy is required to prevent doctors' exodus.

  13. 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

  14. A toolbox for tuberculosis diagnosis: an Indian multicentric study (2006-2008: microbiological results.

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    Philippe H Lagrange

    Full Text Available BACKGROUND: The aim of this multicentric prospective study in India was to assess the value of several microbiological tools that contribute to the diagnosis of tuberculosis (TB according to HIV status. METHODS: Standard microbiological tools on individual specimens were analyzed. RESULTS: Among the 807 patients with active TB, 131 were HIV-infected, 316 HIV-uninfected and 360 had HIV-unknown status. Among the 980 non-active TB subjects, 559 were at low risk and 421 were at high risk of M. tuberculosis (Mtb exposure. Sensitivity of smear microscopy (SM was significantly lower in HIV-infected (42.2% than HIV-uninfected (75.9% (p = 0.0001 and HIV-unknown pulmonary TB patients (61.4% (p = 0.004. Specificity was 94.5% in non-TB patients and 100% in health care workers (HCW and healthy family contacts. Automated liquid culture has significantly higher diagnostic performances than solid culture, measured by sensitivity (74.7% vs. 55.9% (p = 0.0001 and shorter median time to detection (TTD (12.0 vs. 34.0 days (p = 0.0001. Specificity was 100% in HCW and cured-TB patients, but was lower in non-TB patients (89% due to isolation of Mycobacteria other than tuberculosis (MOTT. TTD by both methods was related to AFB score. Contamination rate was low (1.4%. AccuProbe hybridization technique detected Mtb in almost all culture-positive specimens, but MOTT were found in 4.7% with a significantly higher frequency in HIV-infected (15% than HIV-uninfected TB patients (0.5% (p = 0.0007. Pre-test classification significantly increased the diagnostic value of all microbiological tests in pulmonary TB patients (p<0.0001 but to a lesser degree in extrapulmonary TB patients. CONCLUSIONS: Conventional microbiological tools led to results similar to those already described in India special features for HIV-infected TB patients included lower detection by SM and culture. New microbiological assays, such as the automated liquid culture system, showed increased accuracy and

  15. β blockers and mortality after myocardial infarction in patients without heart failure: multicentre prospective cohort study

    Science.gov (United States)

    Riant, Elisabeth; Aissoui, Nadia; Soria, Angèle; Ducrocq, Gregory; Coste, Pierre; Cottin, Yves; Aupetit, Jean François; Bonnefoy, Eric; Blanchard, Didier; Cattan, Simon; Steg, Gabriel; Schiele, François; Ferrières, Jean; Juillière, Yves; Simon, Tabassome; Danchin, Nicolas

    2016-01-01

    Objective To assess the association between early and prolonged β blocker treatment and mortality after acute myocardial infarction. Design Multicentre prospective cohort study. Setting Nationwide French registry of Acute ST- and non-ST-elevation Myocardial Infarction (FAST-MI) (at 223 centres) at the end of 2005. Participants 2679 consecutive patients with acute myocardial infarction and without heart failure or left ventricular dysfunction. Main outcome measures Mortality was assessed at 30 days in relation to early use of β blockers (≤48 hours of admission), at one year in relation to discharge prescription, and at five years in relation to one year use. Results β blockers were used early in 77% (2050/2679) of patients, were prescribed at discharge in 80% (1783/2217), and were still being used in 89% (1230/1383) of those alive at one year. Thirty day mortality was lower in patients taking early β blockers (adjusted hazard ratio 0.46, 95% confidence interval 0.26 to 0.82), whereas the hazard ratio for one year mortality associated with β blockers at discharge was 0.77 (0.46 to 1.30). Persistence of β blockers at one year was not associated with lower five year mortality (hazard ratio 1.19, 0.65 to 2.18). In contrast, five year mortality was lower in patients continuing statins at one year (hazard ratio 0.42, 0.25 to 0.72) compared with those discontinuing statins. Propensity score and sensitivity analyses showed consistent results. Conclusions Early β blocker use was associated with reduced 30 day mortality in patients with acute myocardial infarction, and discontinuation of β blockers at one year was not associated with higher five year mortality. These findings question the utility of prolonged β blocker treatment after acute myocardial infarction in patients without heart failure or left ventricular dysfunction. Trial registration Clinical trials NCT00673036. PMID:27650822

  16. Disease-Specific Regions Outperform Whole-Brain Approaches in Identifying Progressive Supranuclear Palsy: A Multicentric MRI Study

    Science.gov (United States)

    Mueller, Karsten; Jech, Robert; Bonnet, Cecilia; Tintěra, Jaroslav; Hanuška, Jaromir; Möller, Harald E.; Fassbender, Klaus; Ludolph, Albert; Kassubek, Jan; Otto, Markus; Růžička, Evžen; Schroeter, Matthias L.

    2017-01-01

    To identify progressive supranuclear palsy (PSP), we combined voxel-based morphometry (VBM) and support vector machine (SVM) classification using disease-specific features in multicentric magnetic resonance imaging (MRI) data. Structural brain differences were investigated at four centers between 20 patients with PSP and 20 age-matched healthy controls with T1-weighted MRI at 3T. To pave the way for future application in personalized medicine, we applied SVM classification to identify PSP on an individual level besides group analyses based on VBM. We found a major decline in gray matter density in the brainstem, insula, and striatum, and also in frontomedian regions, which is in line with current literature. Moreover, SVM classification yielded high accuracy rates above 80% for disease identification in imaging data. Focusing analyses on disease-specific regions-of-interest (ROI) led to higher accuracy rates compared to a whole-brain approach. Using a polynomial kernel (instead of a linear kernel) led to an increased sensitivity and a higher specificity of disease detection. Our study supports the application of MRI for individual diagnosis of PSP, if combined with SVM approaches. We demonstrate that SVM classification provides high accuracy rates in multicentric data—a prerequisite for potential application in diagnostic routine. PMID:28326008

  17. Effectiveness of different modalities of psychotherapeutic treatment for patients with cluster C personality disorder: results of a large prospective multicentre study

    NARCIS (Netherlands)

    Bartak, A.; Spreeuwenberg, M.D.; Andrea, H.; Holleman, H.; Rijnierse, P.; Rossum, B.V.; Hamers, E.F.M; Meerman, A.M.M.A.; Aerts, J.; Busschbach, J.J.V.; Verheul, R.; Stijnen, T.; Emmelkamp, P.M.G.

    2010-01-01

    Background: No previous studies have compared the effectiveness of different modalities of psychotherapeutic treatment, as defined by different settings and durations, for patients with cluster C personality disorders. The aim of this multicentre study was to compare the effectiveness of 5 treatment

  18. Effectiveness of different modalities of psychotherapeutic treatment for patients with cluster C personality disorders: results of a large prospective multicentre study.

    NARCIS (Netherlands)

    A. Bartak (Anna); M.D. Spreeuwenberg (Marieke); H. Andrea (Helene); L. Holleman (Lot); P. Rijnierse (Piet); B. van Rossum (Bert); E.F.M. Hamers (Elisabeth); A.M.M.A. Meerman (Anke); J. Aerts (Janneke); J.J. van Busschbach (Jan); R. Verheul (Roel); Th. Stijnen (Theo); P.M.G. Emmelkamp (Paul)

    2011-01-01

    textabstractAbstract BACKGROUND: No previous studies have compared the effectiveness of different modalities of psychotherapeutic treatment, as defined by different settings and durations, for patients with cluster C personality disorders. The aim of this multicentre study was to compare the effect

  19. Effectiveness of different modalities of psychotherapeutic treatment for patients with cluster C personality disorder: results of a large prospective multicentre study

    NARCIS (Netherlands)

    A. Bartak; M.D. Spreeuwenberg; H. Andrea; H. Holleman; P. Rijnierse; B.V. Rossum; E.F.M Hamers; A.M.M.A. Meerman; J. Aerts; J.J.V. Busschbach; R. Verheul; T. Stijnen; P.M.G. Emmelkamp

    2010-01-01

    Background: No previous studies have compared the effectiveness of different modalities of psychotherapeutic treatment, as defined by different settings and durations, for patients with cluster C personality disorders. The aim of this multicentre study was to compare the effectiveness of 5 treatment

  20. 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:

  1. Spanish multicentre PIBHE study: Prevalence and immunization of chronic hepatitis B in haemodialysis patients in Spain.

    Science.gov (United States)

    García Agudo, Rebeca; Aoufi Rabih, Sami; Barril Cuadrado, Guillermina; Proy Vega, Beatriz; Arias Arias, Ángel; Herruzo Gallego, José Antonio

    2016-01-01

    The PIBHE study, promoted by the Spanish Liver and Kidney Association and the Dialysis Virus Group of the Spanish Society of Nephrology, is the first study to determine the status of haemodialysis patients with chronic HBV infection and the immunisation against the vaccine. The study has a national multicentre, observational, cross-sectional design and was carried out between January 2013 and 2014. A data collection folder was sent to all the nephrology departments and outpatient haemodialysis units in Spain, to be completed based on patient medical files after informed consent. The data were recorded in a central database. A total of 215 centres participated (15,645 patients), with an HBV prevalence of 1.03%. HCV or HIV was present in 7.2% of the HBV(+) patients. Viral load was below 2,000 IU/ml in 80%. GOT and GPT levels were 19.1±10.1 and 15.9±9.6 IU/ml, respectively. Liver biopsy was performed in 7.1%. Antiviral treatment was prescribed in 30% and suspended in 12.5%: entecavir (13.3%), lamivudine (10%), adefovir and tenofovir (6.7%), and interferon (3.3%). A total of 34.5% were candidates for renal transplantation and 6.9% had not been evaluated; 64.3% were followed up by a gastroenterologist; 27.2% of HBV(-) patients without immunisation had not been vaccinated. Fourteen different immunisation schedules had been used, with an immunisation rate of 58.8%. Mean anti-HBs stood at 165.7±297.8mIU/ml. A total of 72.7% of patients had received a vaccination course; 26.4%, 2 cycles; 1.0%, 3 cycles; and 11.6%, a booster dose. A total of 28.3% had a poor response (anti-HBs 10-99mIU/ml); 22.4%, an optimal response (anti-HBs 100-999mIU/ml); and 7.9%, an excellent response (anti-HBs ≥ 1,000mIU/ml). Age was significantly associated with response to vaccination; the mean age of nonresponders was significantly higher than patients who had a response of any kind (P<.05). The highest probability of an immune response was achieved with 4 doses of 40 mcg of adjuvanted vaccine

  2. Test for CCR5 tropism and treatment with maraviroc in Sicily: an observational retrospective multicentre study

    Directory of Open Access Journals (Sweden)

    B Celesia

    2012-11-01

    Full Text Available Purpose of the study: Maraviroc (MVC is the first CCR5 inhibitor licensed for clinical use. A pre-treatment test is mandatory to identify R5 tropic patients. Aim of this study is to detect indications and results of tropism test and to evaluate efficacy and tolerability of MVC-based regimen. Methods: An observational retrospective multicentre study was performed in Sicily in 15 Infectious Diseases Units. Clinical records of 213 screened for tropism HIV+ subjects were reviewed for age, sex, risk, clinical stage (CDC, CD4 cell count, HIV RNA viral load, therapeutic line, indication and result of test for tropism; within subjects treated with MVC, HIV RNA, CD4 cell count and metabolic parameters trend and adverse events were analysed. Summary of results: Median age 44 (IQR 30–50 years, 67.1% males; 46.3% heterosexuals, 28.6% MSMs, 21.4% IVDUs; 23.7% CDC A, 32.1% CDC B, 44.2% CDC C; median CD4 was 217 (IQR 121–374 cells/µl and mean of HIV RNA was 4.72 (Cl 95% 4.07–4.67 log10 copies/ml; median therapeutic line was 4 (IQR 2–7. 80.8% were submitted to Trofile™ test, 19.2% to genotypic test, 75.5% after a therapeutic failure. 56.8% of subjects screened were R5, 7.5% X4, 21.6% DM, 14% undefined. All X4 patients were tested after a therapeutic failure; patients screened for toxicity were more frequently R5 (75% (p<0.01. 76 (35.7% multi-experienced (at baseline 8% HIV RNA<50 copies/ml, median CD4 cell count 219 (IQR 124–345 cells/µl subjects were treated with MVC plus an optimized background treatment: MVC was associated in 74% of cases with a protease inhibitors (56% darunavir/ritonavir, in 42% with raltegravir, in 56% with a NUC-sparing regimen. After 12 months of treatment 56.8% (ITT analysis and 61.7% (AT of patients had HIV RNA<50 copies/ml; median CD4 cell count was 387 (IQR 222–455 cells/µl. After 24 months 64.8% (ITT 80% (AT had HIV-RNA<50 copies/ml. Median CD4 cell count was 381 (IQR 218.515 cells/µl with a median increase of 168

  3. Management of postoperative pain in abdominal surgery in Spain. A multicentre drug utilization study

    Science.gov (United States)

    Vallano, Antonio; Aguilera, Cristina; Arnau, Josep Maria; Baños, Josep-Eladi; Laporte, Joan-Ramon

    1999-01-01

    Participating centres: Hospital Universitario San Juan, Alicante: Maria Jesús Olaso, Javier Agulló, Clara Faura. Hospital Torrecárdenas, Almería: Carmen Fernández Sánchez, Miguel Lorenzo Campos, Juan Manuel Rodríguez Alonso. Hospital Quirúrgic Adriano, Barcelona: Carmen Alerany Pardo, Paquita Alvarez González, Teresa Martín Benito. Hospital Universitari del Mar-IMIM, Barcelona: Magí Farré, Maite Terán. Corporació Sanitària Parc Taulí, Sabadell: Montserrat Cañellas, Sergio Zavala, Josep Planell. Hospital Universitari de la Santa Creu i Sant Pau: Gonzalo Calvo, Rosa Morros, Silvia Mateo. Hospital General Vall d’Hebron, Barcelona: Carmen Bosch, María José Martínez. Hospital Universitario Virgen de la Victoria, Málaga: Maribel Lucena, José Antonio González, Gabriel Carranque. Hospital Clínico Universitario San Carlos, Madrid: Emilio Vargas, Amparo Gil López-Oliva, Míriam García Mateos. Hospital Universitario Marqués de Valdecilla, Santander: Mario González, Antonio Cuadrado. Hospital Universitario Virgen de la Macarena, Sevilla: Juan Antonio Durán, Pilar Máyquez, María Isabel Serrano. Hospital Universitario Virgen del Rocío, Sevilla: Jaume Torelló, Juan Ramón Castillo, María de las Nieves Merino. Aims Postoperative pain is common in hospital-admitted patients. Its management is determined by different therapeutic traditions and by the attitudes of health professionals in each hospital. The aim of this study was to describe the patterns of prescription and administration of analgesic drugs used for postoperative pain after abdominal surgery in Spanish hospitals, to know the prevalence and the severity of postoperative pain, and to determine the extent of variability in the management of postoperative pain among the participating centres. Methods The study was a multicentre descriptive cross-sectional drug utilization study in 12 Spanish hospitals. The subjects were an unselected sample of consecutive patients undergoing abdominal

  4. An open label randomized multicentre phase IIIb trial comparing parenteral substitution versus best supportive nutritional care in subjects with pancreatic adenocarcinoma receiving 5-FU plus oxaliplatin as 2nd or higher line chemotherapy regarding clinical benefit - PANUSCO

    Directory of Open Access Journals (Sweden)

    Rötzer Ingeborg

    2009-11-01

    Full Text Available Abstract Background Pancreatic cancer is an extremely aggressive malignancy. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia. Recent data indicate that the outcome of oncological patients suffering from cancer cachexia could be improved by parenteral nutrition and that parenteral nutrition results in an improvement of quality of life and in prolonged survival. Currently, there is no recommendation of routine use of parenteral nutrition. Furthermore, there is no clear recommendation for 2nd line therapy (or higher for pancreatic adenocarcinoma but often asked for. Methods/Design PANUSCO is an open label, controlled, prospective, randomized, multicentre phase IIIb trial with two parallel arms. All patients will be treated with 5-fluorouracil, folinic acid and oxaliplatin on an outpatient basis at the study sites. Additionally, all patients will receive best supportive nutritional care (BSNC. In the experimental group BSNC will be expanded with parenteral nutrition (PN. In contrast, patients in the control group obtain solely BSNC. Parenteral nutrition will be applied overnight and at home by experienced medical staff. A total of 120 patients are planned to be enrolled. Primary endpoint is the comparison of the treatment groups with respect to event-free survival (EFS, defined as the time from randomization till time to development of an event defined as either an impairment (change from baseline of at least ten points in EORTC QLQ-C30, functional domain total score or withdrawal due to fulfilling the special defined stopping criteria for chemotherapy as well as for nutritional intervention (NI or death from any cause (whichever occurs first. Discussion The aim of this clinical trial is to evaluate whether parenteral nutrition in combination with defined 2nd line or higher chemotherapy has an impact on quality of life for patients suffering from pancreatic adenocarcinoma. Trial registration Current

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

    Directory of Open Access Journals (Sweden)

    Aladar Bruno Ianes

    2017-05-01

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

  6. 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

    2015-01-01

    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 l

  7. 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...

  8. A multicentre study of patient survival, disability, quality of life and cost of care - Among patients with AIDS in northern Italy

    NARCIS (Netherlands)

    Tramarin, A; Campostrini, S; Postma, MJ; Calleri, G; Tolley, K; Parise, N; de Lalla, F

    2004-01-01

    Objective: To describe the epidemiological, clinical and economic changes that occurred in the HIV epidemic in Italy prior to and after the introduction of highly active antiretroviral therapy (HAART). Design: A prospective, observational, multicentre case-control study was conducted comparing data,

  9. Contact sensitisation in hand eczema patients-relation to subdiagnosis, severity and quality of life: a multi-centre study

    DEFF Research Database (Denmark)

    Agner, Tove; Andersen, Klaus Ejner; Brandao, Francisco M;

    2009-01-01

    BACKGROUND: Contact sensitisation has been identified as a factor associated with poor prognosis for patients with hand eczema. OBJECTIVES: To study implications of contact sensitisation with respect to severity, quality of life (QoL) and subdiagnosis of hand eczema. METHODS: The study...... was performed as a multi-centre, cross-sectional study from 10 European clinics. All patients were patch tested, and severity of hand eczema assessed by Hand Eczema Severity Index. A multi-variate analysis was performed to explore which factors influenced severity, QoL and sick leave. RESULTS: A total 416...... eczema and presence of contact sensitisation were independent risk factors for increased severity as measured by Hand Eczema Severity Index. Furthermore, the severity of hand eczema increased by the number of contact sensitisations detected (P = 0.023). High age and personal history of atopic eczema were...

  10. [Dynamics of functional parameters in different schemes for bronchial asthma therapy: results of the STRELA-ACT multicentre study].

    Science.gov (United States)

    Ogorodova, L M; Kulikov, E S; Deev, I A; Cherniak, B A; Fassakhov, R S

    2011-01-01

    Different strategies for disease control in real clinical practice are compared in terms of dynamics of functional parameters in patients with persistent bronchial asthma. This prospective multicentre surveillance study was carried out in 19 Russian clinics using the common protocol. The patients were divided in 3 groups in accordance with the changes of basal antiinflammatory therapy during the study period. Group A--stepwise increase in the extent of combined salmoterol/fluticason therapy, group B--long-term stable-dose salmoterol/fluticason therapy, group C--salmoterol/fluticason therapy with gradual decrease of the dose and/or transition to an alternative variant. Statistical analysis using Statistica 6.0 program included data from 543 patients. The results suggest that the two first modalities increased the level of control (ACT test) and improved characteristics of external respiration throughout the study period. Strategy 3 was associated with a decrease in the external respiration function and the level of control.

  11. Contact sensitisation in hand eczema patients-relation to subdiagnosis, severity and quality of life: a multi-centre study

    DEFF Research Database (Denmark)

    Agner, T.; Andersen, K.E.; Brandao, F.M.

    2009-01-01

    Background Contact sensitisation has been identified as a factor associated with poor prognosis for patients with hand eczema. Objectives To study implications of contact sensitisation with respect to severity, quality of life (QoL) and subdiagnosis of hand eczema. Methods The study was performed...... as a multi-centre, cross-sectional study from 10 European clinics. All patients were patch tested, and severity of hand eczema assessed by Hand Eczema Severity Index. A multi-variate analysis was performed to explore which factors influenced severity, QoL and sick leave. Results A total 416 patients were...... and presence of contact sensitisation were independent risk factors for increased severity as measured by Hand Eczema Severity Index. Furthermore, the severity of hand eczema increased by the number of contact sensitisations detected (P = 0.023). High age and personal history of atopic eczema were independent...

  12. 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.

  13. A 3-year multicentre randomized controlled trial of etonogestrel- and levonorgestrel-releasing contraceptive implants, with non-randomized matched copper-intrauterine device controls.

    Science.gov (United States)

    Bahamondes, Luis; Brache, Vivian; Meirik, Olav; Ali, Moazzam; Habib, Ndema; Landoulsi, Sihem

    2015-11-01

    Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight

  14. The effect of two cognitive aid designs on team functioning during intra-operative anaphylaxis emergencies: a multi-centre simulation study.

    Science.gov (United States)

    Marshall, S D; Sanderson, P; McIntosh, C A; Kolawole, H

    2016-04-01

    This multi-centre repeated measures study was undertaken to determine how contrasting designs of cognitive aids affect team performance during simulated intra-operative anaphylaxis crises. A total of 24 teams consisting of a consultant anaesthetist, an anaesthetic trainee and anaesthetic assistant managed three simulated intra-operative anaphylaxis emergencies. Each team was assigned at random to a counterbalanced order of: no cognitive aid; a linear cognitive aid; and a branched cognitive aid, and scored for team functioning. Scores were significantly higher with a linear compared with either a branched version of the cognitive aid or no cognitive aid for 'Team Overall Behavioural Performance', difference between study groups (F-value) 5.8, p = 0.01. Aggregate scores were higher with the linear compared with the branched aid design (p = 0.03). Cognitive aids improve co-ordination of the team's activities and support team members to verbalise their actions. A linear design of cognitive aid improves team functioning more than a branched design.

  15. A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis

    OpenAIRE

    Fan, Stanley; Ross, Calum; Mitra, Sandip; Kalra, Philip; Heaton, Jeremy; Hunter, John; Plone, Melissa; Pritchard, Nick

    2009-01-01

    Background. Sevelamer carbonate is an improved, buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphataemia in CKD patients. Sevelamer carbonate formulated as a powder for oral suspension presents a novel, patient-friendly alternative to tablet phosphate binders. This study compared the safety and efficacy of sevelamer carbonate powder with sevelamer hydrochloride tablets in CKD patients on haemodialysis. Methods. This was a multi-centre, open-label, randomized,...

  16. Crenobalneotherapy (spa therapy) in patients with knee and generalized osteoarthritis: a post-hoc subgroup analysis of a large multicentre randomized trial.

    Science.gov (United States)

    Forestier, R; Genty, C; Waller, B; Françon, A; Desfour, H; Rolland, C; Roques, C-F; Bosson, J-L

    2014-06-01

    To determine whether the addition of spa therapy to home exercises provides any benefit over exercises and the usual treatment alone in the management of generalised osteoarthritis associated with knee osteoarthritis. This study was a post-hoc subgroup analysis of our randomised multicentre trial (www.clinicaltrial.gov: NCT00348777). Participants who met the inclusion criteria of generalized osteoarthritis (Kellgren, American College of Rheumatology, or Dougados criteria) were extracted from the original randomised controlled trial. They had been randomised using Zelen randomisation. The treatment group received 18days of spa treatment in addition to a home exercise programme. Main outcome was number of patients achieving minimal clinically important improvement at six months (MCII) (≥-19.9mm on the VAS pain scale and/or ≥-9.1 points in a WOMAC function subscale), and no knee surgery. Secondary outcomes included the "patient acceptable symptom state" (PASS) defined as VAS pain ≤32.3mm and/or WOMAC function subscale ≤31 points. From the original 462 participants, 214 patients could be categorized as having generalised osteoarthritis. At sixth month, 182 (88 in control and 94 in SA group) patients, were analysed for the main criteria. MCII was observed more often in the spa group (n=52/94 vs. 38/88, P=0.010). There was no difference for the PASS (n=19/88 vs. 26/94, P=0.343). This study indicates that spa therapy with home exercises may be superior to home exercise alone in the management of patients with GOA associated with knee OA. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

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

    DEFF Research Database (Denmark)

    Jacobsen, S; Petersen, J; Ullman, S

    1998-01-01

    influence on survival related to mortality caused by infections. Diffuse central nervous system disease and myocarditis were related to increased SLE-related mortality, whereas photosensitivity predicted a decreased mortality. Non-fatal infections and thrombotic events predicted a decreased overall survival......In this Danish multicentre study, predictive clinical factors of mortality and survival were calculated for 513 patients with systemic lupus erythematosus (SLE), 122 of whom died within a mean observation period of 8.2 years equalling a mortality rate of 2.9% per year. Survival rates were 97%, 91......%, 76% and 64% after 1, 5, 10 and 15 years, respectively. The direct causes of death included SLE (n = 35), infections (n = 25), malignancy (n = 9), cardiovascular disease (n = 32) and other causes (n = 21). Uni- and multivariate analyses of survival and mortality were performed for all deaths...

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

    Directory of Open Access Journals (Sweden)

    Devroe Johanna

    2011-09-01

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

  19. A multi-centric prospective study: Anxiety and associated factors among parents of children undergoing mild surgery in ENT

    Directory of Open Access Journals (Sweden)

    Mehmet Akdağ

    2014-06-01

    Full Text Available Objective: The aim of this study to evaluate the anxiety and expectancy among parents of children undergoing surgery in the multi-centric surgery units. Methods: Following approval from the ethics committee, a questionnaire was given to the parents of 123 children who were undergoing surgery in the multi-centric surgery units. The parents were informed that their answers would not affect the care given to their children. The questionnaire was evaluated using the State-Trait Anxiety Inventory (STAI-I and STAI-II. Results: The STAI results indicated that the parents’ anxiety level increased before their children underwent surgery. In addition, there was a negative correlation between STAI-II scores and high levels of wealth (p= 0.004. Also, those with steady employment and higher levels of education had lower anxiety levels and difference was significant (p=0.001. The state anxiety levels were unaffected by family income and education, but the trait anxiety levels decreased with increasing income and education. Mothers were less anxious if their child had undergone surgery in the past, while this result was not significant statistically (p>0.05. Parents were most commonly concerned with possible complications from the surgery and/or anesthesia. Conclusion: Results of our study indicate that parents of children undergoing surgery that have steady employment, to be informed, previously has been administered anesthesia or surgery, high level of wealth and education was observed less anxiety than others. J Clin Exp Invest 2014; 5 (2: 206-210

  20. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Benítez Mència

    2008-05-01

    Full Text Available Abstract Background Influenza vaccines are recommended for administration by the intramuscular route. However, many physicians use the subcutaneous route for patients receiving an oral anticoagulant because this route is thought to induce fewer hemorrhagic side effects. Our aim is to assess the safety of intramuscular administration of influenza vaccine in patients on oral anticoagulation therapy. Methods Design: Randomised, controlled, single blinded, multi-centre clinical trial. Setting: 4 primary care practices in Barcelona, Spain. Participants: 229 patients on oral anticoagulation therapy eligible for influenza vaccine during the 2003–2004 season. Interventions: intramuscular administration of influenza vaccine in the experimental group (129 patients compared to subcutaneous administration in the control group (100 patients. Primary outcome: change in the circumference of the arm at the site of injection at 24 hours. Secondary outcomes: appearance of local reactions and pain at 24 hours and at 10 days; change in INR (International Normalized Ratio at 24 hours and at 10 days. Analysis was by intention to treat using the 95% confidence intervals of the proportions or mean differences. Results Baseline variables in the two groups were similar. No major side effects or major haemorrhage during the follow-up period were reported. No significant differences were observed in the primary outcome between the two groups. The appearance of local adverse reactions was more frequent in the subcutaneous administration group (37,4% vs. 17,4%, 95% confidence interval of the difference 8,2% to 31,8%. Conclusion This study shows that the intramuscular administration route of influenza vaccine in patients on anticoagulant therapy does not have more side effects than the subcutaneous administration route. Registration number NCT00137579 at clinicaltrials.gov

  1. Neuroimaging Findings in First Unprovoked Seizures: A Multicentric Study in Tehran

    Directory of Open Access Journals (Sweden)

    Mohsen MOLLA MOHAMMADI

    2013-11-01

    Full Text Available How to Cite This Article: Molla Mohammadi M, Tonekaboni SH, Khatami AR, Azargashb E, Tavasoli A, Javadzadeh M, Zamani GR. Neuroimaging Findings in First Unprovoked Seizures: A Multicentric Study in Tehran. Iran J Child Neurol. 2013 Autumn; 7(4:24-31.ObjectiveSeizure is an emergency in pediatrics. It really matters to the parents of the involved child to have information about the causes, management and prognosis.First unprovoked seizures (FUS are seizures that occur in patients without fever, trauma or infection. Due to the rapid improvement in diagnostic techniques in the last few decades, the etiology will be revealed and this term will no longer exist. This Study was designed to evaluate brain imaging findings in FUS patients. Materials & MethodsNinety-six children with FUS, who were admitted in three major children’s hospitals in Tehran, underwent brain imaging and were enrolled into the study.The decision about the type of imaging (CT or MRI was based on the patient’s medical and financial conditions. An expert radiologist in the field of pediatric neuroimaging interpreted the images. ResultsAltogether, 27.1% had abnormal findings of which 29.2% were in the brain MRI group and 14.3% were in the brain CT scan group.Abnormal results were gliosis (10.4%, hemorrhage (4.2%, dysgenesis (2.1%, dysmyelination (7.3%, encephalomalacy (1%, atrophy (5.2% and infarction (2.1%. In some patients, the lesions were in 2 or 3 sites and some had more than one type of lesion.There was no association between the duration, age and type of seizure and imaging abnormlities. However, we found an association between the location of the lesion and the type of seizure. ConclusionWe recommend brain imaging in all patients with FUS and apart from some exceptions, brain MRI is superior to CT. ReferencesJohnston MV. Siezure in childhood. In: Kliegman RM, Behrman RE, editors. Nelson text book of pediatrics. 18th ed. Philadelphia: Saunders; 2010. p. 2457

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2014-11-15

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

  3. Determinants of Attrition to Follow-Up in a Multicentre Cohort Study in Children-Results from the IDEFICS Study

    Directory of Open Access Journals (Sweden)

    Sabrina Hense

    2013-01-01

    Full Text Available Cohort participant retention is a crucial element and may depend on several factors. Based on data from a multicentre cohort of European children, the effect of baseline participation on attrition and the association with and the impact of single determinants in relation to the extent of attrition were investigated. Data was available for 16,225 children from the IDEFICS baseline survey (2007/2008. Attrition was defined as nonparticipation in the first follow-up examination (2009/2010. Determinants of attrition were analysed by logistic regression. The statistical significance level was set at α=0.01 to account for the large sample size. The strongest associations were seen for baseline item non-response, especially when information on migration background (odds ratio (OR = 1.55; 99% confidence interval (CI: 1.04, 2.31, single parenthood (OR = 1.37; 99% CI: 1.12, 1.67, or well-being (OR = 1.46; 99% CI: 1.19, 1.79 was lacking. Drop-out proportion rose with the number of missing items. Overweight, low education, single parenthood and low well-being scores were independent determinants of attrition. Baseline participation, and the individual determinant effects seemed unrelated to the variation of the extent of attrition between study centres. A high level of item nonresponse as well as overweight and disadvantageous sociodemographic conditions were identified as main attrition determinants, suggesting the consideration of these aspects in conduct and analysis of cohort studies in childhood obesity research.

  4. The Australian Multiple Sclerosis (MS immunotherapy study: a prospective, multicentre study of drug utilisation using the MSBase platform.

    Directory of Open Access Journals (Sweden)

    Vilija G Jokubaitis

    Full Text Available OBJECTIVE: To prospectively characterise treatment persistence and predictors of treatment discontinuation in an Australian relapsing-remitting multiple sclerosis (RRMS population. METHODS: Tertiary MS treatment centres participating in the MSBase registry prospectively assessed treatment utilisation, persistence, predictors of treatment discontinuation and switch rates. Multivariable survival analyses were used to compare treatment persistence between drugs and to identify predictors of treatment discontinuation. RESULTS: 1113 RRMS patients were studied. Patients persisted on their first disease-modifying therapy (DMT for a median of 2.5 years. Treatment persistence on GA was shorter than on all IFNβ products (p<0.03. Younger age at treatment initiation and higher EDSS were predictive of DMT discontinuation. Patients persisted on subsequent DMTs, for 2.3 years. Patients receiving natalizumab (NAT as a subsequent DMT persisted longer on treatment than those on IFNβ or GA (p<0.000. The primary reason for treatment discontinuation for any drug class was poor tolerability. Annualised switch or cessation rates were 9.5-12.5% for individual IFNβ products, 11.6% for GA and 4.4% for NAT. CONCLUSION: This multicentre MS cohort study is the first to directly compare treatment persistence on IFNβ and GA to NAT. We report that treatment persistence in our Australian RRMS population is short, although patients receiving IFNβ as a first DMT persisted longer on treatment than those on GA. Additionally, patients receiving NAT as a subsequent DMT were more likely to persist on treatment than those switched to IFNβ or GA. EDSS and age at DMT initiation were predictive of DMT discontinuation. Treatment intolerance was the principal reason for treatment cessation.

  5. EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA): a protocol of a European multicentre observational study

    Science.gov (United States)

    Gutiérrez-Gutiérrez, Belén; Sojo-Dorado, Jesús; Bravo-Ferrer, José; Cuperus, Nienke; de Kraker, Marlieke; Kostyanev, Tomislav; Raka, Lul; Daikos, George; Feifel, Jan; Folgori, Laura; Pascual, Alvaro; Goossens, Herman; O'Brien, Seamus; Bonten, Marc J M; Rodríguez-Baño, Jesús

    2017-01-01

    Introduction The rapid worldwide spread of carbapenem-resistant Enterobacteriaceae (CRE) constitutes a major challenge. The aim of the EUropean prospective cohort study on Enterobacteriaceae showing REsistance to CArbapenems (EURECA), which is part of the Innovative Medicines Initiative Joint Undertaking (IMI JU) funded COMBACTE-CARE project, is to investigate risk factors for and outcome determinants of CRE infections to inform randomised clinical trial designs and to provide a historical cohort that could eventually be used for future comparisons with new drugs targeting CRE. Methods A multicentre (50 sites), multinational (11 European countries), analytical observational project was designed, comprising 3 studies. The aims of study 1 (a prospective cohort study) include characterising the features, clinical management and outcomes of hospitalised patients with intra-abdominal infection, pneumonia, complicated urinary tract infections and bloodstream infections caused by CRE (202 patients in each group). The main outcomes will be 30-day all-cause mortality and clinical response. Study 2 (a nested case–control study) will identify the risk factors for target infections caused by CRE; 248 selected patients from study 1 will be matched with patients with carbapenem-susceptible Enterobacteriaceae (1:1) and with hospitalised patients (1:3) and will provide a historical cohort of patients with CRE infections. Study 3 (a matched cohort study) will follow patients in study 2 in order to assess mortality, length of stay and hospital costs associated with CRE. All patients will be followed for 30 days. Different, up-to-date statistical methods will be applied to come to unbiased estimates for all 3 studies. Ethics and dissemination Before-study sites will be initiated, approval will be sought from appropriate regulatory agencies and local Ethics Committees of Research or Institutional Review Boards (IRBs) to conduct the study in accordance with regulatory requirements

  6. Reappraisal of known malaria resistance loci in a large multi-centre study

    Science.gov (United States)

    Rockett, Kirk A.; Clarke, Geraldine M.; Fitzpatrick, Kathryn; Hubbart, Christina; Jeffreys, Anna E.; Rowlands, Kate; Craik, Rachel; Jallow, Muminatou; Conway, David J.; Bojang, Kalifa A.; Pinder, Margaret; Usen, Stanley; Sisay-Joof, Fatoumatta; Sirugo, Giorgio; Toure, Ousmane; Thera, Mahamadou A.; Konate, Salimata; Sissoko, Sibiry; Niangaly, Amadou; Poudiougou, Belco; Mangano, Valentina D.; Bougouma, Edith C.; Sirima, Sodiomon B.; Modiano, David; Amenga-Etego, Lucas N.; Ghansah, Anita; Koram, Kwadwo A.; Wilson, Michael D.; Enimil, Anthony; Evans, Jennifer; Amodu, Olukemi; Olaniyan, Subulade; Apinjoh, Tobias; Mugri, Regina; Ndi, Andre; Ndila, Carolyne M.; Uyoga, Sophie; Macharia, Alexander; Peshu, Norbert; Williams, Thomas N.; Manjurano, Alphaxard; Riley, Eleanor; Drakeley, Chris; Reyburn, Hugh; Nyirongo, Vysaul; Kachala, David; Molyneux, Malcolm; Dunstan, Sarah J.; Phu, Nguyen Hoan; Ngoc Quyen, Nguyen Thi; Thai, Cao Quang; Hien, Tran Tinh; Manning, Laurens; Laman, Moses; Siba, Peter; Karunajeewa, Harin; Allen, Steve; Allen, Angela; Davis, Timothy M. E.; Michon, Pascal; Mueller, Ivo; Green, Angie; Molloy, Sile; Johnson, Kimberly J.; Kerasidou, Angeliki; Cornelius, Victoria; Hart, Lee; Vanderwal, Aaron; SanJoaquin, Miguel; Band, Gavin; Le, Si Quang; Pirinen, Matti; Sepúlveda, Nuno; Spencer, Chris C.A.; Clark, Taane G.; Agbenyega, Tsiri; Achidi, Eric; Doumbo, Ogobara; Farrar, Jeremy; Marsh, Kevin; Taylor, Terrie; Kwiatkowski, Dominic P.

    2015-01-01

    Many human genetic associations with resistance to malaria have been reported but few have been reliably replicated. We collected data on 11,890 cases of severe malaria due to Plasmodium falciparum and 17,441 controls from 12 locations in Africa, Asia and Oceania. There was strong evidence of association with the HBB, ABO, ATP2B4, G6PD and CD40LG loci but previously reported associations at 22 other loci did not replicate in the multi-centre analysis. The large sample size made it possible to identify authentic genetic effects that are heterogeneous across populations or phenotypes, a striking example being the main African form of G6PD deficiency, which reduced the risk of cerebral malaria but increased the risk of severe malarial anaemia. The finding that G6PD deficiency has opposing effects on different fatal complications of P. falciparum infection indicates that the evolutionary origins of this common human genetic disorder are more complex than previously supposed. PMID:25261933

  7. [Effectivity and satisfaction with the treatment for dyslipidemia with pitavastatin. Multicentric, descriptive, post authorised and observational study (REINA study)].

    Science.gov (United States)

    Rodríguez Arroyo, Luis Alberto; Díaz Rodríguez, Angel; Pintó Sala, Xavier; Coca Payeras, Antonio; Rius Tarruella, Joan

    2014-01-01

    Evaluating the therapeutical adherence as well as the patient' satisfaction with the treatment should be considered to optimize lipidic control. The REINA Study evaluates the grade of satisfaction in dyslipidemic patients treated with pitavastatin. The current study was observational, descriptive, transversal and multi-centric with patients from our country only. The following data were collected in each case: Morisky-Green test and TSQM-9 for patients older than 18 years old, with dyslipidemia treated with pitavastatin in the last 12 weeks. We studied 6,489 patients (60.0% males) from Primary Health (52.7%) and Specialised Health (47.3%), with age (mean) = 60.9 ± 11.2 years by aleatory sampling. 72.3% of patients achieved an adequate control with 2mg/day of pitavastatin. General satisfaction with the treatment was 73.20 points (95% CI: 58.17-87.23). Patients who followed the treatment (65%) showed better data of satisfaction with the drug (77.70 [95% CI: 65.20-90.20]), of global satisfaction (75.00 [95% CI: 61.50-88.50]) and their satisfaction with the drug efficiency was higher (72.50 [95% CI: 57.70-87.30]) than in the patients who did not finish the treatment (72.70 [95% CI: 59.30-85.74]; 68.5 [95% CI: 53.20-83.80] and 67.80 [95% CI: 53.70-81.90], respectively), P < .0001, without any difference between the two primary care systems. The validation of the satisfaction is a crucial indicator in the evaluation of the services offered in health. Patients with the highest grade of satisfaction present better therapeutical adherence, and such a relation is bidirectional. The individuals who are satisfied and who followed the treatment obtained better clinical results. Pitavastatin is an effective therapeutic alternative for patients with dyslipidemia. Copyright © 2013 Sociedad Española de Arteriosclerosis. Published by Elsevier España. All rights reserved.

  8. Efficacy and safety of a nano-emulsion gel formulation of adapalene 0.1% and clindamycin 1% combination in acne vulgaris: A randomized, open label, active-controlled, multicentric, phase IV clinical trial

    Directory of Open Access Journals (Sweden)

    Siva Prasad

    2012-01-01

    Full Text Available Background: Acne vulgaris is a very common skin disease with a significant detrimental effect on the quality of life of the patients. Aims: To assess the comparative efficacy and safety of a nano-emulsion gel formulation of adapalene and clindamycin combination with its conventional formulation in the treatment of acne vulgaris of the face. It was a prospective, randomized, open label, active-controlled, multicentric, clinical trial. Methods: Eligible patients suffering from acne vulgaris of the face were randomized to receive once-daily treatment with a nano-emulsion gel or conventional gel formulation of adapalene 0.1% and clindamycin (as phosphate 1% combination for 12 weeks. Total, inflammatory and noninflammatory lesion counts, with grading of acne severity were carried out on a monthly basis. Safety assessments were done to determine the comparative local and systemic tolerability. Two-tailed significance testing was carried out with appropriate statistical tests, and P-values < 0.05 were considered as significant. Results: 209/212 patients enrolled in the study were eligible for efficacy and safety assessments in both nano-emulsion gel (118/119 patients and conventional gel (91/93 patients groups. Significantly better reductions in total (79.7% vs. 62.7%, inflammatory (88.7% vs. 71.4% and noninflammatory (74.9% vs. 58.4% lesions were reported with the nano-emulsion gel as compared to the conventional gel (P < 0.001 for all. Mean acne severity score also reduced significantly more with the nano-emulsion formulation (1.9 ± 0.9 vs. 1.4 ± 1.0; P < 0.001 than the comparator. Significantly lower incidence and lesser intensity of adverse events like local irritation (4.2% vs. 19.8%; P < 0.05 and erythema (0.8% vs. 9.9%; P < 0.05 were recorded with the nano-emulsion gel. Conclusions: The nano-emulsion gel formulation of adapalene and clindamycin combination appears to be more efficacious and better tolerated than the conventional formulation

  9. Antibiotic resistance and population structure of cystic fibrosis Pseudomonas aeruginosa isolates from a Spanish multi-centre study.

    Science.gov (United States)

    López-Causapé, Carla; de Dios-Caballero, Juan; Cobo, Marta; Escribano, Amparo; Asensio, Óscar; Oliver, Antonio; Del Campo, Rosa; Cantón, Rafael; Solé, Amparó; Cortell, Isidoro; Asensio, Oscar; García, Gloria; Martínez, María Teresa; Cols, María; Salcedo, Antonio; Vázquez, Carlos; Baranda, Félix; Girón, Rosa; Quintana, Esther; Delgado, Isabel; de Miguel, María Ángeles; García, Marta; Oliva, Concepción; Prados, María Concepción; Barrio, María Isabel; Pastor, María Dolores; Olveira, Casilda; de Gracia, Javier; Álvarez, Antonio; Escribano, Amparo; Castillo, Silvia; Figuerola, Joan; Togores, Bernat; Oliver, Antonio; López, Carla; de Dios Caballero, Juan; Tato, Marta; Máiz, Luis; Suárez, Lucrecia; Cantón, Rafael

    2017-07-20

    The first Spanish multi-centre study on the microbiology of cystic fibrosis (CF) was conducted from 2013 to 2014. The study involved 24 CF units from 17 hospitals, and recruited 341 patients. The aim of this study was to characterise Pseudomonas aeruginosa isolates, 79 of which were recovered from 75 (22%) patients. The study determined the population structure, antibiotic susceptibility profile and genetic background of the strains. Fifty-five percent of the isolates were multi-drug-resistant, and 16% were extensively-drug-resistant. Defective mutS and mutL genes were observed in mutator isolates (15.2%). Considerable genetic diversity was observed by pulsed-field gel electrophoresis (70 patterns) and multi-locus sequence typing (72 sequence types). International epidemic clones were not detected. Fifty-one new and 14 previously described array tube (AT) genotypes were detected by AT technology. This study found a genetically unrelated and highly diverse CF P. aeruginosa population in Spain, not represented by the epidemic clones widely distributed across Europe, with multiple combinations of virulence factors and high antimicrobial resistance rates (except for colistin). Copyright © 2017 Elsevier B.V. and International Society of Chemotherapy. All rights reserved.

  10. Patterns and predictors of sitting time over ten years in a large population-based Canadian sample: Findings from the Canadian Multicentre Osteoporosis Study (CaMos).

    Science.gov (United States)

    Gebel, Klaus; Pont, Sarah; Ding, Ding; Bauman, Adrian E; Chau, Josephine Y; Berger, Claudie; Prior, Jerilynn C

    2017-03-01

    Our objective was to describe patterns and predictors of sedentary behavior (sitting time) over 10 years among a large Canadian cohort. Data are from the Canadian Multicentre Osteoporosis Study, a prospective study of women and men randomly selected from the general population. Respondents reported socio-demographics, lifestyle behaviors and health outcomes in interviewer-administered questionnaires; weight and height were measured. Baseline data were collected between 1995 and 1997 (n = 9418; participation rate = 42%), and at 5- (n = 7648) and 10-year follow-ups (n = 5567). Total sitting time was summed across domain-specific questions at three time points and dichotomized into "low" (≤ 7 h/day) and "high" (> 7 h/day), based on recent meta-analytic evidence on time sitting and all-cause mortality. Ten-year sitting patterns were classified as "consistently high", "consistently low", "increased", "decreased", and "mixed". Predictors of sedentary behavior patterns were explored using chi-square tests, ANOVA and logistic regression. At baseline (mean age = 62.1 years ± 13.4) average sitting was 6.9 h/day; it was 7.0 at 5- and 10-year follow-ups (p for trend = 0.12). Overall 23% reported consistently high sitting time, 22% consistently low sitting, 14% decreased sitting, 17% increased sitting with 24% mixed patterns. Consistently high sitters were more likely to be men, university educated, full-time employed, obese, and to report consistently low physical activity levels. This is one of the first population-based studies to explore patterns of sedentary behavior (multi-domain sitting) within men and women over years. Risk classification of sitting among many adults changed during follow-up. Thus, studies of sitting and health would benefit from multiple measures of sitting over time.

  11. Diclofenac epolamine plus heparin plaster versus diclofenac epolamine plaster in mild to moderate ankle sprain: a randomized, double-blind, parallel-group, placebo-controlled, multicentre, phase III trial.

    Science.gov (United States)

    Costantino, Cosimo; Kwarecki, Jacek; Samokhin, Anatoly V; Mautone, Giuseppe; Rovati, Stefano

    2011-01-01

    In general sports, ankle sprain is the most frequently reported ankle injury and can cause chronic lateral ankle pain and tenderness. Treatment with NSAIDs is preferred, and several topical NSAID formulations are now available, helping to avoid the systemic adverse events typically associated with oral preparations. To compare the efficacy and tolerability of a newly developed fixed-dose diclofenac epolamine (diclofenac hydroxyethylpyrrolidine, DHEP)/heparin plaster (Flectoparin® Tissugel) with that of a DHEP (Flector EP Tissugel®) or placebo plaster in the treatment of mild to moderate ankle sprain in adults. This was a randomized, double-blind, parallel-group, placebo-controlled, multicentre, phase III study conducted in the emergency medical centres of hospitals or private clinics in Europe. Outpatients aged 18-65 years who had suffered an acute ankle sprain (O'Donoghue grade I or II in severity, with external lateral ligament involvement) within the previous 48 hours and had peri-malleolar oedema were eligible for inclusion. A total of 430 patients were randomized to receive a DHEP/heparin 1.3%/5600 IU (n = 142), DHEP 1.3% (n = 146) or placebo (n = 142) plaster, applied once daily to the injured ankle for a total of 7 days. The primary endpoint was the mean change from baseline in pain on movement on day 3, as measured by a visual analogue scale (VAS). The DHEP/heparin plaster was associated with a significantly (p = 0.002) greater mean reduction from baseline in pain on movement after 3 days of treatment than the DHEP plaster (-24.2 vs -18.8 mm VAS), with each active treatment providing significantly (p ≤ 0.005) greater pain relief than placebo (-13.7 mm VAS). Both DHEP/heparin and DHEP were also effective in relieving other measures of pain, with DHEP/heparin recipients experiencing significantly less daily pain while leaning on the injured limb than DHEP recipients (p plaster and DHEP plaster were both well tolerated, with

  12. Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

    Directory of Open Access Journals (Sweden)

    Grant Adrian M

    2006-12-01

    Full Text Available Abstract Background Securing and managing finances for multicentre randomised controlled trials is a highly complex activity which is rarely considered in the research literature. This paper describes the process of financial negotiation and the impact of financial considerations in four UK multicentre trials. These trials had met, or were on schedule to meet, recruitment targets agreed with their public-sector funders. The trials were considered within a larger study examining factors which might be associated with trial recruitment (STEPS. Methods In-depth semi-structured telephone interviews were conducted in 2003–04 with 45 individuals with various responsibilities to one of the four trials. Interviewees were recruited through purposive and then snowball sampling. Interview transcripts were analysed with the assistance of the qualitative package Atlas-ti. Results The data suggest that the UK system of dividing funds into research, treatment and NHS support costs brought the trial teams into complicated negotiations with multiple funders. The divisions were somewhat malleable and the funding system was used differently in each trial. The fact that all funders had the potential to influence and shape the trials considered here was an important issue as the perspectives of applicants and funders could diverge. The extent and range of industry involvement in non-industry-led trials was striking. Three broad periods of financial work (foundation, maintenance, and resourcing completion were identified. From development to completion of a trial, the trialists had to be resourceful and flexible, adapting to changing internal and external circumstances. In each period, trialists and collaborators could face changing costs and challenges. Each trial extended the recruitment period; three required funding extensions from MRC or HTA. Conclusion This study highlights complex financial aspects of planning and conducting trials, especially where multiple

  13. Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: A national multicentre study

    DEFF Research Database (Denmark)

    Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole

    2012-01-01

    Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely...... unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning....

  14. The effect of core stability training on balance and mobility in ambulant individuals with multiple sclerosis: a multi-centre series of single case studies.

    Science.gov (United States)

    Freeman, J A; Gear, M; Pauli, A; Cowan, P; Finnigan, C; Hunter, H; Mobberley, C; Nock, A; Sims, R; Thain, J

    2010-11-01

    Core stability training is popular in the management of people with multiple sclerosis (MS); however, scientific evidence to support its effectiveness is scarce. To explore the effectiveness of core stability training on balance and mobility. A multi-centre series of eight single case studies was undertaken. Eight ambulant individuals with stable MS participated in 16 face-to-face core stability training sessions, delivered by a neurophysiotherapist, plus a daily home exercise programme. A range of outcomes were measured: 10-m timed walk, 12-item MS walking scale, timed get up and go, functional reach tests, timed single leg stance, visual analogue scales of two activities, and the Activities-specific Balance Confidence Scale. Visual analysis of trend, level and slope demonstrated improvement in five subjects (62%) in seven measures. This was confirmed by the two standard deviation band method of analysis for six measures. Analysis of group data (repeated measures within subjects analysis of variance) indicated significant improvement between baseline and intervention phases for timed walk (p = 0.019), MSWS-12 Scale (p = 0.041), forward (p = 0.015) and lateral reach (p = 0.012). In general, no further improvements were made following withdrawal of the intervention. This study provides preliminary evidence of the effectiveness of an 8-week core stability training programme in improving balance and mobility in ambulant people with MS. Variations in response to intervention are evident. Assessor-blinded randomized controlled studies are required to confirm these findings and determine patient characteristics which identify those who benefit most from this intervention.

  15. Predicting arterial blood gas and lactate from central venous blood analysis in critically ill patients: a multicentre, prospective, diagnostic accuracy study.

    Science.gov (United States)

    Boulain, T; Garot, D; Vignon, P; Lascarrou, J-B; Benzekri-Lefevre, D; Dequin, P-F

    2016-09-01

    The estimation of arterial blood gas and lactate from central venous blood analysis and pulse oximetry [Formula: see text] readings has not yet been extensively validated. In this multicentre, prospective study performed in 590 patients with acute circulatory failure, we measured blood gases and lactate in simultaneous central venous and arterial blood samples at 6 h intervals during the first 24 h after insertion of central venous and arterial catheters. The study population was randomly divided in a 2:1 ratio into model derivation and validation sets. We derived predictive models of arterial pH, carbon dioxide partial pressure, oxygen saturation, and lactate, using clinical characteristics, [Formula: see text], and central venous blood gas values as predictors, and then tested their performance in the validation set. In the validation set, the agreement intervals between predicted and actual values were -0.078/+0.084 units for arterial pH, -1.32/+1.36 kPa for arterial carbon dioxide partial pressure, -5.15/+4.47% for arterial oxygen saturation, and -1.07/+1.05 mmol litre(-1) for arterial lactate (i.e. around two times our predefined clinically tolerable intervals for all variables). This led to ∼5% (or less) of extreme-to-extreme misclassifications, thus giving our predictive models only marginal agreement. Thresholds of predicted variables (as determined from the derivation set) showed high predictive values (consistently >94%), to exclude abnormal arterial values in the validation set. Using clinical characteristics, [Formula: see text], and central venous blood analysis, we predicted arterial blood gas and lactate values with marginal accuracy in patients with circulatory failure. Further studies are required to establish whether the developed models can be used with acceptable safety. © The Author 2016. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  16. Visceral leishmaniasis on the Indian sub-continent: a multi-centre study of the costs of three interventions for the control of the sandfly vector, Phlebotomus argentipes.

    Science.gov (United States)

    Das, M; Banjara, M; Chowdhury, R; Kumar, V; Rijal, S; Joshi, A; Akhter, S; Das, P; Kroeger, A

    2008-12-01

    The sandflies that transmit the parasites causing human visceral leishmaniasis (VL) can be controlled by several methods, including indoor residual spraying (IRS), the use of long-lasting insecticidal nets (LLIN) and ecological vector management (EVM). The financial costs of each of these three methods of sandfly control have recently been assessed and compared, in a multi-centre study based on the Indian sub-continent. In each of the four study sites (two in Nepal and one each in India and Bangladesh), 24 neighbourhoods were randomly selected in districts with high incidences of VL. The costs of the three interventions were then prospectively assessed in each study neighbourhood, in the local currency, and then converted to U.S. dollars at the prevailing exchange rate in the country concerned. The costs of IRS, which ranged from U.S.$2.4-11.7 (mean = U.S.$5.9) per household-year, were greater than those of LLIN (U.S.$3.5-5.1/household-year, with a mean of U. S.$4.5) but less than those of EVM (U. S.$5.0- 14.0/household-year, with a mean of U.S.$8.7). These results indicate that LLIN and IRS may be the cheaper options for the control of sandflies on the Indian sub-continent, and that EVM should perhaps only be taken up as a complimentary and voluntary method. Various combinations of these interventions (based on country-specific social and economic factors) may, however, be the best and most cost-effective choice.

  17. A pollen extract (Cernilton) in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome: a multicentre, randomised, prospective, double-blind, placebo-controlled phase 3 study.

    Science.gov (United States)

    Wagenlehner, Florian M E; Schneider, Henning; Ludwig, Martin; Schnitker, Jörg; Brähler, Elmar; Weidner, Wolfgang

    2009-09-01

    National Institutes of Health (NIH) category III prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent condition for which no standardised treatment exists. To assess the safety and efficacy of a standardised pollen extract in men with inflammatory CP/CPPS. We conducted a multicentre, prospective, randomised, double-blind, placebo-controlled phase 3 study comparing the pollen extract (Cernilton) to placebo in men with CP/CPPS (NIH IIIA) attending urologic centres. Participants were randomised to receive oral capsules of the pollen extract (two capsules q8h) or placebo for 12 wk. The primary endpoint of the study was symptomatic improvement in the pain domain of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI individual domains and total score, the number of leukocytes in post-prostatic massage urine (VB3), the International Prostate Symptom Score (IPSS), and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 wk. In the intention-to-treat analysis, 139 men were randomly allocated to the pollen extract (n=70) or placebo (n=69). The individual domains pain (p=0.0086) and quality of life (QoL; p=0.0250) as well as the total NIH-CPSI score (p=0.0126) were significantly improved after 12 wk of treatment with pollen extract compared to placebo. Response, defined as a decrease of the NIH-CPSI total score by at least 25% or at least 6 points, was seen in the pollen extract versus placebo group in 70.6% and 50.0% (p=0.0141), respectively. Adverse events were minor in all patients studied. Compared to placebo, the pollen extract significantly improved total symptoms, pain, and QoL in patients with inflammatory CP/CPPS without severe side-effects.

  18. Impact of attenuation correction and gated acquisition in SPECT myocardial perfusion imaging: results of the multicentre SPAG (SPECT Attenuation Correction vs Gated) study

    Energy Technology Data Exchange (ETDEWEB)

    Genovesi, Dario; Giorgetti, Assuero; Gimelli, Alessia; Kusch, Annette; D' Aragona Tagliavia, Irene; Casagranda, Mirta; Marzullo, Paolo [Fondazione CNR-Regione Toscana ' ' G. Monasterio' ' , Nuclear Medicine, Pisa (Italy); Cannizzaro, Giorgio [A.O.V. Cervello, Nuclear Medicine, Palermo (Italy); Giubbini, Raffaele; Bertagna, Francesco [Spedali Civili, Nuclear Medicine, Brescia (Italy); Fagioli, Giorgio; Rossi, Massimiliano; Romeo, Annadina [Ospedale Maggiore, Nuclear Medicine, Bologna (Italy); Bertolaccini, Pietro; Bonini, Rita [Ospedale SS Giacomo e Cristoforo, Nuclear Medicine, Massa (Italy)

    2011-10-15

    In clinical myocardial single photon emission computed tomography (SPECT), attenuation artefacts may cause a loss of specificity in the identification of diseased vessels that can be corrected by means of gated SPECT (GSPECT) acquisition or CT attenuation correction (AC). The purpose of this multicentre study was to assess the impact of GSPECT and AC on the diagnostic performance of myocardial scintigraphy, according to patient's sex, body mass index (BMI) and site of coronary artery disease (CAD). We studied a group of 104 patients who underwent coronary angiography within 1 month before or after the SPECT study. Patients with a BMI > 27 were considered ''overweight''. Attenuation-corrected and standard GSPECT early images were randomly interpreted by three readers blinded to the clinical data. In the whole group, GSPECT and AC showed a diagnostic accuracy of 86.5% (sensitivity 82%, specificity 93%) and 77% (sensitivity 75.4%, specificity 81.4%), respectively (p < 0.05). In women, when anterior ischaemia was matched with CAD, AC failed to show any increase in specificity (AC 63.6% vs GSPECT 63.6%) with evident loss of sensitivity (AC 72.7% vs GSPECT 90.9%). AC significantly improved SPECT specificity in the identification of right CAD in overweight men (AC 100% vs GSPECT 66.7%, p <0.05). AC improved specificity in the evaluation of right CAD in overweight men. In the other evaluable subgroups specificity was not significantly affected while sensitivity was frequently reduced. (orig.)

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

    Directory of Open Access Journals (Sweden)

    Krämer Jürgen

    2004-03-01

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

  20. Management of dental extraction in patients undergoing anticoagulant treatment. Results from a large, multicentre, prospective, case-control study.

    Science.gov (United States)

    Bacci, Christian; Maglione, Michele; Favero, Lorenzo; Perini, Alessandro; Di Lenarda, Roberto; Berengo, Mario; Zanon, Ezio

    2010-11-01

    Following favourable results from a previous study, a large, multicentre, prospective, case-control study was performed to further assess the incidence of bleeding complications after dental extraction in patients taking oral anticoagulant therapy (OAT). Four hundred fifty-one patients being treated with warfarin who required dental extraction were compared with a control group of 449 non-anticoagulated subjects undergoing the same procedure. In the warfarin-treated group, the oral anticoagulant regimen was maintained unchanged, such that the patients had an International Normalised Ratio ranging between 1.8 and 4, and local haemostatic measures (i.e. fibrin sponges, silk sutures and gauzes saturated with tranexamic acid) were adopted. All the procedures were performed in an outpatient setting. Seven bleeding complications occurred in the OAT group and four in the control group; the difference in the number of bleeding events between the two groups was not statistically significant (OR=1.754; 95% CI 0.510 - 6.034; p=0.3727). No post-operative late bleeds requiring hospitalisation and/or blood transfusions were recorded, and the adjunctive local haemostatic measures were adequate to stop the bleeding. The results of our protocol applied in this large, multicenter study show that dental extractions can be performed easily and safely in anticoagulated outpatients without any modification of the ongoing anticoagulant therapy, thus minimising costs and reducing discomfort for patients.

  1. Erythropoietin in amyotrophic lateral sclerosis: a multicentre, randomised, double blind, placebo controlled, phase III study

    Science.gov (United States)

    Lauria, Giuseppe; Dalla Bella, Eleonora; Antonini, Giovanni; Borghero, Giuseppe; Capasso, Margherita; Caponnetto, Claudia; Chiò, Adriano; Corbo, Massimo; Eleopra, Roberto; Fazio, Raffaella; Filosto, Massimiliano; Giannini, Fabio; Granieri, Enrico; La Bella, Vincenzo; Logroscino, Giancarlo; Mandrioli, Jessica; Mazzini, Letizia; Monsurrò, Maria Rosaria; Mora, Gabriele; Pietrini, Vladimiro; Quatrale, Rocco; Rizzi, Romana; Salvi, Fabrizio; Siciliano, Gabriele; Sorarù, Gianni; Volanti, Paolo; Tramacere, Irene; Filippini, Graziella

    2015-01-01

    Objective To assess the efficacy of recombinant human erythropoietin (rhEPO) in amyotrophic lateral sclerosis (ALS). Methods Patients with probable laboratory-supported, probable or definite ALS were enrolled by 25 Italian centres and randomly assigned (1:1) to receive intravenous rhEPO 40 000 IU or placebo fortnightly as add-on treatment to riluzole 100 mg daily for 12 months. The primary composite outcome was survival, tracheotomy or >23 h non-invasive ventilation (NIV). Secondary outcomes were ALSFRS-R, slow vital capacity (sVC) and quality of life (ALSAQ-40) decline. Tolerability was evaluated analysing adverse events (AEs) causing withdrawal. The randomisation sequence was computer-generated by blocks, stratified by centre, disease severity (ALSFRS-R cut-off score of 33) and onset (spinal or bulbar). The main outcome analysis was performed in all randomised patients and by intention-to-treat for the entire population and patients stratified by severity and onset. The study is registered, EudraCT 2009-016066-91. Results We randomly assigned 208 patients, of whom 5 (1 rhEPO and 4 placebo) withdrew consent and 3 (placebo) became ineligible (retinal thrombosis, respiratory insufficiency, SOD1 mutation) before receiving treatment; 103 receiving rhEPO and 97 placebo were eligible for analysis. At 12 months, the annualised rate of death (rhEPO 0.11, 95% CI 0.06 to 0.20; placebo: 0.08, CI 0.04 to 0.17), tracheotomy or >23 h NIV (rhEPO 0.16, CI 0.10 to 0.27; placebo 0.18, CI 0.11 to 0.30) did not differ between groups, also after stratification by onset and ALSFRS-R at baseline. Withdrawal due to AE was 16.5% in rhEPO and 8.3% in placebo. No differences were found for secondary outcomes. Conclusions RhEPO 40 000 IU fortnightly did not change the course of ALS. PMID:25595151

  2. Pediatricians' attitudes and costs of bronchiolitis in the emergency department: a prospective multicentre study.

    Science.gov (United States)

    Garcia-Marcos, Luis; Valverde-Molina, José; Pavlovic-Nesic, Svetlana; Claret-Teruel, Gemma; Peñalba-Citores, Ana C; Nehme-Álvarez, Daniel; Korta-Murua, Javier; Sánchez-Etxaniz, Jesus; Alonso-Salas, Maria T; Campos-Calleja, Carmen; Fernández-Villar, Andrés; Rodríguez-Suarez, Julian

    2014-10-01

    How pediatricians manage bronchiolitis and the derived total costs (direct and indirect) in the emergency department (ED) have not been fully characterized. The aim of the present study is to calculate those costs in a European country. A prospective and observational study, including 10 EDs of tertiary hospitals throughout Spain and during the bronchiolitis season 2010-2011, was performed. Every ED recruited children on random days of the week (3 days per week; always including one non-working day per every week). Recruitment aimed at a total sample size of 600 children. Direct (diagnostic procedures, time spent in the ED and medication) and indirect costs (work hours lost by parents, babysitting, travels, and meals) were collected. Comparisons between bronchiolitis caused by respiratory syncytial virus (RSV) and non-RSV bronchiolitis, as well as costs across severity categories were performed with the Kruskal-Wallis test. A multiple regression model was built to assess the influence of several of the studied factors on the total costs, including a RSV positive test and episode severity as independent variables; and gender, age, attending nursery school, preterm birth, low birth weight, smoker mother during pregnancy, and current smoker father as covariates. From the 664 recruited children, direct mean costs were €213.2 ± 91.8 and indirect ones were €35.9 ± 55.3; the total costs being €249.2 ± 122.9. Costs were significantly higher in children positive to RSV and rose with increased severity. Those associations were maintained in the multiple regression analysis. Although relatively low at the individual level (€249.2, mean total cost) the costs for just the ED expenses of bronchiolitis in Spain would add up to about €20 million per year. © 2013 Wiley Periodicals, Inc.

  3. Efficacy and safety of telmisartan vs. losartan in control of mild-to-moderate hypertension: a multicentre, randomised, double-blind study.

    Science.gov (United States)

    Zhu, J R; Bai, J; Cai, N S; Tang, B; Fan, W H; Guo, J Z; Ke, Y N; Guo, J X; Sheng, L H; Lu, Z Y; Cheng, N N

    2004-12-01

    This multicentre, randomised, double-blind, double-dummy, parallel-group study compared the efficacy and safety of telmisartan with those of losartan after 8 weeks' treatment. In total, 330 patients with mild-to-moderate hypertension (systolic blood pressure [SBP] mmHg; diastolic blood pressure [DBP] 95-109 mmHg) were randomly assigned to receive once-daily treatment with telmisartan 40 mg (n = 164) or losartan 50 mg (n = 166). After 4 weeks' treatment, if a patient's DBP was > or = 90 mmHg, the dose was increased to telmisartan 80 mg or losartan 100 mg, respectively. The results show that mean trough seated blood pressure was reduced significantly more in the telmisartan group than that in the losartan group (SBP 12.5 mmHg vs. 9.4 mmHg, p = 0.037; DBP 10.9 mmHg vs. 9.3 mmHg, p = 0.030). The overall DBP response rate (reduction from baseline in mean seated DBP > or = 10 mmHg and/or a mean seated DBP mmHg) at the end of the study in the telmisartan group was higher than that in losartan group (70.1% vs. 58.7%, p = 0.020). At both the low and high doses, the DBP response rates for telmisartan were significantly higher than those for losartan (telmisartan 40 mg vs. losartan 50 mg: 46.3% vs. 32.5%, p = 0.010; telmisartan 80 mg vs. losartan 100 mg: 79.3% vs. 65.3%, p = 0.008). Adverse events with the two treatments were comparable (telmisartan vs. losartan 23.2% vs. 22.9%, p = 0.952). Most events were mild in intensity and abated within 72 h. Thus, telmisartan 40 mg or 80 mg administered once daily can reduce SBP and DBP effectively and safely.

  4. Pressure ulcer knowledge of registered nurses, assistant nurses and student nurses: a descriptive, comparative multicentre study in Sweden.

    Science.gov (United States)

    Gunningberg, Lena; Mårtensson, Gunilla; Mamhidir, Anna-Greta; Florin, Jan; Muntlin Athlin, Åsa; Bååth, Carina

    2015-08-01

    The aim of this study was to describe and compare the knowledge of registered nurses (RNs), assistant nurses (ANs) and student nurses (SNs) about preventing pressure ulcers (PUs). PU prevention behaviours in the clinical practice of RNs and ANs were also explored. A descriptive, comparative multicentre study was performed. Hospital wards and universities from four Swedish county councils participated. In total, 415 participants (RN, AN and SN) completed the Pressure Ulcer Knowledge Assessment Tool. The mean knowledge score for the sample was 58·9%. The highest scores were found in the themes 'nutrition' (83·1%) and 'risk assessment' (75·7%). The lowest scores were found in the themes 'reduction in the amount of pressure and shear' (47·5%) and 'classification and observation' (55·5%). RNs and SNs had higher scores than ANs on 'aetiology and causes'. SNs had higher scores than RNs and ANs on 'nutrition'. It has been concluded that there is a knowledge deficit in PU prevention among nursing staff in Sweden. A major educational campaign needs to be undertaken both in hospital settings and in nursing education.

  5. Coffee, tea and decaffeinated coffee in relation to hepatocellular carcinoma in a European population: multicentre, prospective cohort study.

    Science.gov (United States)

    Bamia, Christina; Lagiou, Pagona; Jenab, Mazda; Trichopoulou, Antonia; Fedirko, Veronika; Aleksandrova, Krasimira; Pischon, Tobias; Overvad, Kim; Olsen, Anja; Tjønneland, Anne; Boutron-Ruault, Marie-Christine; Fagherazzi, Guy; Racine, Antoine; Kuhn, Tilman; Boeing, Heiner; Floegel, Anna; Benetou, Vasiliki; Palli, Domenico; Grioni, Sara; Panico, Salvatore; Tumino, Rosario; Vineis, Paolo; Bueno-de-Mesquita, H B; Dik, Vincent K; Bhoo-Pathy, Nirmala; Uiterwaal, Cuno S P M; Weiderpass, Elisabete; Lund, Eiliv; Quirós, J Ramón; Zamora-Ros, Raul; Molina-Montes, Esther; Chirlaque, Maria-Dolores; Ardanaz, Eva; Dorronsoro, Miren; Lindkvist, Björn; Wallström, Peter; Nilsson, Lena Maria; Sund, Malin; Khaw, Kay-Tee; Wareham, Nick; Bradbury, Kathryn E; Travis, Ruth C; Ferrari, Pietro; Duarte-Salles, Talita; Stepien, Magdalena; Gunter, Marc; Murphy, Neil; Riboli, Elio; Trichopoulos, Dimitrios

    2015-04-15

    Inverse associations of coffee and/or tea in relation to hepatocellular carcinoma (HCC) risk have been consistently identified in studies conducted mostly in Asia where consumption patterns of such beverages differ from Europe. In the European Prospective Investigation into Cancer and nutrition (EPIC), we identified 201 HCC cases among 486,799 men/women, after a median follow-up of 11 years. We calculated adjusted hazard ratios (HRs) for HCC incidence in relation to quintiles/categories of coffee/tea intakes. We found that increased coffee and tea intakes were consistently associated with lower HCC risk. The inverse associations were substantial, monotonic and statistically significant. Coffee consumers in the highest compared to the lowest quintile had lower HCC risk by 72% [HR: 0.28; 95% confidence intervals (CIs): 0.16-0.50, p-trend coffee intake with HCC were apparent for caffeinated (p-trend = 0.009), but not decaffeinated (p-trend = 0.45) coffee for which, however, data were available for a fraction of subjects. Results from this multicentre, European cohort study strengthen the existing evidence regarding the inverse association between coffee/tea and HCC risk. Given the apparent lack of heterogeneity of these associations by HCC risk factors and that coffee/tea are universal exposures, our results could have important implications for high HCC risk subjects.

  6. Positron emission tomography changes management and prognostic stratification in patients with oesophageal cancer: results of a multicentre prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Chatterton, B.E. [Royal Adelaide Hospital, Department of Nuclear Medicine and PET, Adelaide, SA (Australia); Ho Shon, I. [Liverpool Hospital, Department of Nuclear Medicine and PET, Sydney (Australia); Baldey, A. [MIA at Monash Medical Centre, Melbourne (Australia); Lenzo, N.; Patrikeos, A. [Sir Charles Gairdner Hospital, WA PET/Cyclotron Service, Perth (Australia); Kelley, B.; Wong, D. [The Wesley Hospital, Southern X-Ray Clinics, Brisbane (Australia); Ramshaw, J.E. [Australian and New Zealand Association of Physicians in Nuclear Medicine, Melbourne (Australia); Scott, A.M. [Austin Hospital, Centre for PET, and Ludwig Institute for Cancer Research, Melbourne (Australia)

    2009-03-15

    The aims of this study were (1) to determine the incremental information provided by {sup 18}F-FDG positron emission tomography (PET) in staging patients with oesophageal cancer, and (2) to determine the impact of PET staging on post-PET clinical management of oesophageal cancer, and on prognosis. In a multicentre, single-arm open study, patients with proved oesophageal cancer without definite distant metastases and regarded as suitable for potentially curative treatment were examined by PET. Clinicians were requested to supply a management plan before and another plan after being supplied with the PET scan results. Patients were followed for at least 1 year for outcome analysis. A total of 129 patients (104 men, mean age 67 y) were recruited. PET detected additional sites of disease in 53 patients (41%). Significant changes in management (high or medium impact) were observed in 38% of patients, primarily as a result of identifying additional sites of disease and/or confirming previously equivocal regional and distant metastases. Progression-free survival was significantly shorter in patients found to have additional lesions on PET (p < 0.05), but was not related to SUV{sub max}. These findings demonstrate the significant impact of PET on the clinical management of patients with newly diagnosed oesophageal carcinoma, and on prognostic stratification of these patients. (orig.)

  7. Etiology of newly-diagnosed cases of chronic liver disease in Southern Italy: results of a prospective multicentric study

    Directory of Open Access Journals (Sweden)

    Antonio Ascione

    2013-11-01

    Full Text Available The pattern of liver diseases has radically changed in our country over the last few decades. We prospectively collected data on the newly-diagnosed cases of chronic liver diseases in a region of southern Italy after about a decade from the last epidemiological study. We conducted a multicentric prospective study that enrolled 631 patients from 21 Liver Centers of the Campania region (Southern Italy at their first hospital admission or at their first outpatient visit. In our cohort of 631 patients (367 males, 263 females, 397 (62.9% were hepatitis C virus (HCV positive, 75 (11.9% were hepatitis B virus (HBV positive, 8 (1.3% were co-infected by HBV and HCV, 73 (11.6% had an alcoholic liver disease and 64 (10.1% had a nonalcoholic fatty liver disease. HBV infection was present in young people with a higher-than-expected prevalence, despite the vaccination program which should have involved this population. HCV chronic hepatitis still remains the most common cause of liver disease in our region. HBV infection still continues to represent a health problem in young people, despite the vaccination program.

  8. Changing prevalence patterns in endoscopic and histological diagnosis of gastritis? Data from a cross-sectional Central European multicentre study.

    Science.gov (United States)

    Wolf, Eva-Maria; Plieschnegger, Wolfgang; Geppert, Michael; Wigginghaus, Bernd; Höss, Gabriele M; Eherer, Andreas; Schneider, Nora I; Hauer, Almuthe; Rehak, Peter; Vieth, Michael; Langner, Cord

    2014-05-01

    Traditionally, Helicobacter infection is considered to be the most common cause of gastritis. In the cross-sectional Central European histoGERD trial, we assessed the prevalence of different types of gastritis, correlating histological and endoscopic diagnoses. A total of 1123 individuals participated in an observational multicentre study. Endoscopists classified individuals as positive or negative for gastritis and rendered the putative cause. Pathologists evaluated biopsy specimens based upon the Updated Sydney System. Histological diagnosis of gastritis was made in 639 (56.9%) participants. In all, 210 (18.7%) individuals were diagnosed with Helicobacter gastritis, 215 (19.1%) with post Helicobacter gastritis, 234 (20.8%) with reactive gastropathy, 26 (2.3%) with autoimmune gastritis, and 6 (0.5%) with focally enhanced gastritis related to Crohn's disease. In 46 out of 639 (7.2%) individuals diagnosed with gastritis, combinations of different histological subtypes were noted the most common being reactive gastropathy and post Helicobacter gastritis. Endoscopic diagnosis of gastritis was made in 534 (47.6%) individuals. Reactive gastropathy was more common than active Helicobacter gastritis, and the majority of cases attributable to Helicobacter infection were no longer ongoing, i.e. post Helicobacter gastritis. Agreement between histological and endoscopic diagnoses was better in reactive gastropathy than in Helicobacter gastritis. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  9. Patch test reactions to cosmetic allergens in 1995-1997 and 2000-2002 in Finland--a multicentre study.

    Science.gov (United States)

    Hasan, T; Rantanen, T; Alanko, K; Harvima, R J; Jolanki, R; Kalimo, K; Lahti, A; Lammintausta, K; Lauerma, A I; Laukkanen, A; Luukkaala, T; Riekki, R; Turjanmaa, K; Varjonen, E; Vuorela, A-M

    2005-07-01

    Contact sensitivity to cosmetics is common, but the sensitizing chemicals vary between countries and study periods. The present survey aimed at revealing the recent trends in patch test sensitivity with cosmetic chemicals in Finland. We report a retrospective multicentre survey of patch test reactions focusing on cosmetic-related substances and comparing the test results in 1995-97 with those in 2000-02. The most striking increases in the frequency of the patch test sensitivity were found with balsam of Peru and propolis from 4.0% to 6.2% (P methyldibromo glutaronitrile increased, although not significantly, from 1.0% to 1.5%. An increasing tendency was also found with hair dye chemicals 4-aminophenol and toluene-2,5-diamine or toluene-2,5-diamine sulfate from 1.3% to 3.8% and from 1.4% to 5.2%, respectively, while such a tendency was not found among permanent wave chemicals. The sensitivity level of fragrance mix remained the same (6% - 7%). We conclude that surveys revealing the state of sensitivity to cosmetic chemicals should be performed periodically in different countries.

  10. Designed sound and music environment in postanaesthesia care units--a multicentre study of patients and staff.

    Science.gov (United States)

    Thorgaard, Per; Ertmann, Ellen; Hansen, Vibeke; Noerregaard, Anni; Hansen, Vibeke; Spanggaard, Lene

    2005-08-01

    A multicentre study in five postanaesthesia care units (PACUs) was performed to investigate patient and staff opinion of a specially designed music environment (DME), related to geographical location. Patients (325) and staff (91) described their opinion by means of a questionnaire-anonymously in the case of staff. Patients were not asked beforehand for permission to play music. Amongst patients 267 (83%) found the sound environment with DME pleasant or very pleasant, 26 (6%) found it unpleasant, whereas 32 (11%) answered "no opinion". The opinion of the patients did not differ significantly with geographical location. A strong correlation (P<0.05) between a positive attitude towards DME and degree of relaxation and satisfaction with stay was found. The staff had an equally positive attitude towards the DME; but theirs varied significantly with location. The opinion of the staff was more similar concerning the beneficial effect on working conditions and distress, but varied still significantly. The opinion of the staff had no demonstrable impact on that of the patients.

  11. Live birth after artificial oocyte activation using a ready-to-use ionophore: a prospective multicentre study.

    Science.gov (United States)

    Ebner, Thomas; Montag, Markus; Montag, M; Van der Ven, K; Van der Ven, H; Ebner, T; Shebl, O; Oppelt, P; Hirchenhain, J; Krüssel, J; Maxrath, B; Gnoth, C; Friol, K; Tigges, J; Wünsch, E; Luckhaus, J; Beerkotte, A; Weiss, D; Grunwald, K; Struller, D; Etien, C

    2015-04-01

    Artificial oocyte activation has been proposed as a suitable means to overcome the problem of failed or impaired fertilization after intracytoplasmic sperm injection (ICSI). In a multicentre setting artificial oocyte activation was applied to 101 patients who were diagnosed with fertilization abnormalities (e.g. less than 50% fertilized oocytes) in a previous conventional ICSI cycle. Female gametes were activated for 15 min immediately after ICSI using a ready-to-use Ca(2+)-ionophore solution (A23187). Fertilization, pregnancy and live birth rates were compared with the preceding cycle without activation. The fertilization rate of 48% in the study cycles was significantly higher compared with the 25% in the control cycles (P splitting of the historical control group into failed (0%), low (1-30%) and moderate fertilization rate (31-50%) showed that all groups significantly benefitted (P embryo transfer cancelled compared with their previous treatments (1/101 versus 15/101). In total, 99% of the patients had an improved outcome with A23187 application resulting in a 28% live birth rate (35 babies). These data suggest that artificial oocyte activation using a ready-to-use compound is an efficient method.

  12. Study protocol of a multicentre randomised controlled trial of self-help cognitive behaviour therapy for working women with menopausal symptoms (MENOS@Work).

    Science.gov (United States)

    Hunter, Myra S; Hardy, Claire; Norton, Sam; Griffiths, Amanda

    2016-10-01

    Hot flushes and night sweats (HFNS) - the main symptoms of the menopause transition - can reduce quality of life and are particularly difficult to manage at work. A cognitive behaviour therapy (CBT) intervention has been developed specifically for HFNS that is theoretically based and shown to reduce significantly the impact of HFNS in several randomised controlled trials (RCTs). Self-help CBT has been found to be as effective as group CBT for these symptoms, but these interventions are not widely available in the workplace. This paper describes the protocol of an RCT aiming to assess the efficacy of CBT for menopausal symptoms implemented in the workplace, with a nested qualitative study to examine acceptability and feasibility. One hundred menopausal working women, aged 45-60 years, experiencing bothersome HFNS for two months will be recruited from several (2-10) large organisations into a multicentre randomised controlled trial. Women will be randomly assigned to either treatment (a self-help CBT intervention lasting 4 weeks) or to a no treatment-wait control condition (NTWC), following a screening interview, consent, and completion of a baseline questionnaire. All participants will complete follow-up questionnaires at 6 weeks and 20 weeks post-randomisation. The primary outcome is the rating of HFNS; secondary measures include HFNS frequency, mood, quality of life, attitudes to menopause, HFNS beliefs and behaviours, work absence and presenteeism, job satisfaction, job stress, job performance, disclosure to managers and turnover intention. Adherence, acceptability and feasibility will be assessed at 20 weeks post-randomisation in questionnaires and qualitative interviews. Upon trial completion, the control group will also be offered the intervention. This is the first randomised controlled trial of a self-management intervention tailored for working women who have troublesome menopausal symptoms. Clin.Gov NCT02623374. Copyright © 2016 Elsevier Ireland Ltd. All

  13. Oxygen therapy multicentric study--a nationwide audit to oxygen therapy procedures in internal medicine wards.

    Science.gov (United States)

    Neves, J T; Lobão, M J

    2012-01-01

    Oxygen therapy is a common and important treatment in Internal Medicine wards, however, several studies report that it isn't provided accordingly with the best of care. The goal of this work is to evaluate oxygen therapy procedures in Portuguese Internal Medicine wards, comparing them to the standards established by the British Thoracic Society (BTS) in its consensus statement "BTS guideline for emergency oxygen use in adult patients". Between September 3rd and 23rd 2010, each one of the 24 enrolled hospitals audited the oxygen therapy procedures for one randomly chosen day. All Internal Medicine inpatients under oxygen therapy or with oxygen prescription were included. Data was collected regarding oxygen prescription, administration and monitoring. Of the 1549 inpatients, 773 met inclusion criteria. There was an oxygen prescription in 93,4%. Most prescriptions were by a fixed dose (82,4%), but only 11,6% of those stated all the required parameters. Absence of oxygen therapy duration and monitoring were the most frequent errors. Oxygen was administered to only 77,0% of the patients with fixed dose prescriptions. FiO(2) or flow rate and the delivery device were the same as prescribed in 70,9 and 89,2% of the patients, respectively. Out of the 127 patients with oxygen therapy prescriptions by target SatO(2) range, 82,7% were on the prescribed SatO(2) objective range. Several errors were found in oxygen therapy procedures, particularly regarding fixed dose prescriptions, jeopardizing the patients. Although recommended by BTS, oxygen therapy prescriptions by target SatO(2) range are still a minority.

  14. The impact of occupational therapy in Parkinson's disease: a randomized controlled feasibility study

    NARCIS (Netherlands)

    Sturkenboom, I.H.W.M.; Graff, M.J.L.; Borm, G.F.; Veenhuizen, Y.; Bloem, B.R.; Munneke, M.; Nijhuis-Van der Sanden, M.W.G.

    2013-01-01

    AIM: To evaluate the feasibility of a randomized controlled trial including process and potential impact of occupational therapy in Parkinson's disease. DESIGN: Process and outcome were quantitatively and qualitatively evaluated in an exploratory multicentre, two-armed randomized controlled trial at

  15. Evaluation of an algorithm for the treatment of persistent diarrhoea: a multicentre study. International Working Group on Persistent Diarrhoea.

    Science.gov (United States)

    1996-01-01

    Described are the findings of a multicentre cohort study to test an algorithm for the treatment of persistent diarrhoea relying on the use of locally available, inexpensive foods, vitamin and mineral supplementation, and the selective use of antibiotics to treat associated infections. The initial diet (A) contained cereals, vegetable oil, and animal milk or yoghurt. The diet (B) offered when the patient did not improve with the initial regimen was lactose free, and the energy from cereals was partially replaced by simple sugars. A total of 460 children with persistent diarrhoea, aged 4-36 months, were enrolled at study centres in Bangladesh, India, Mexico, Pakistan, Peru, and Viet Nam. The study population was young (11.5 +/- 5.7 months) and malnourished (mean weight-for-age Z-score, -3.03 +/- 0.86), and severe associated conditions were common (45% required rehydration or treatment of severe infections on admission). The overall success rate of the treatment algorithm was 80% (95% CI, 76-84%). The recovery rate among all children with only diet A was 65% (95% CI, 61-70%), and was 71% (95% CI, 62-81%) for those evaluated after receiving diet B. The children at the greatest risk for treatment failure were those who had acute associated illnesses (including cholera, septicaemia, and urinary tract infections), required intravenous antibiotics, and had the highest initial purging rates. Our results indicate that the short-term treatment of persistent diarrhoea can be accomplished safely and effectively, in the majority of patients, using an algorithm relying primarily on locally available foods and simple clinical guidelines. This study should help establish rational and effective treatment for persistent diarrhoea.

  16. Validity and reliability of the braden scale and the influence of other risk factors: a multi-centre prospective study.

    Science.gov (United States)

    Halfens, R J; Van Achterberg, T; Bal, R M

    2000-08-01

    The Braden scale is one of the most intensively studied risk assessment scales used in identifying the risk of developing pressure sores. However, not all studies show that the sensitivity and specificity of this scale is sufficient. This study, therefore, investigated whether adding new risk factors can enhance the sensitivity and specificity of the Braden scale. The Braden scale was tested in a prospective multi-centre design. The nurses of 11 wards filled in the Braden scale every 5 days for each patient who was admitted without pressure sores and who had a probable stay of at least 10 days. Based on a literature study and in-depth interviews with experts, the Braden scale was extended by the risk factor blood circulation. In addition, other risk factors, which are more or less stable patient characteristics, were measured during the admission of the patient. Independent research assistants measured the presence of pressure sores twice a week. As the external criterion for the risk of developing pressure sores, the presence of pressure sores and/or the use of preventive activities was used. Results showed that the original Braden scale was a reliable instrument and that the sensitivity and specificity was sufficient. However, reformulating the factors moisture and nutrition, and adding the risk factor age could enhance the sensitivity and specificity. Furthermore, results showed that the factors sensory perception, and friction and shear were especially important risk factors for the Braden scale. In fact, using only the factors sensory perception, friction and shear, moisture (a reformulated factor) and age give the highest explained variance of the risk of developing pressure sores. The added risk factor blood circulation, did not enhance the sensitivity and specificity of the original Braden scale. Suggestions are given on how to use risk assessment scales in practice.

  17. 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.

  18. A multi-centre cohort study shows no association between experienced violence and labour dystocia in nulliparous women at term

    Directory of Open Access Journals (Sweden)

    Dykes Anna-Karin

    2011-02-01

    Full Text Available Abstract Background Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. Methods A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1% met the protocol criteria for dystocia. Results Among the total cohort, 940 (35.4% women reported experience of violence, and among these, 66 (2.5% women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26 of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08, OR 0.90, 95% CI (0.54-1.50, respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96. Conclusions Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia.

  19. Screening for diabetes mellitus among tuberculosis patients in Southern Nigeria: a multi-centre implementation study under programme settings

    Science.gov (United States)

    Ekeke, Ngozi; Ukwaja, Kingsley N.; Chukwu, Joseph N.; Nwafor, Charles C.; Meka, Anthony O.; Egbagbe, Eruke E.; Soyinka, Festus O.; Alobu, Isaac; Agujiobi, Ifeanyi; Akingbesote, Samuel; Igbinigie, Osagie; Offor, Job B.; Madichie, Nelson O.; Alphonsus, Chukwuka; Anyim, Moses C.; Mbah, Obinna K.; Oshi, Daniel C.

    2017-01-01

    Implementation studies are recommended to assess the feasibility and effectiveness of programmes. In Nigeria, little is known about the burden of diabetes mellitus (DM) among tuberculosis (TB) patients. The objective of this study was to determine screening efficacy, prevalence of DM and determinants of DM among TB patients. We report on a multi-centre implementation study carried-out in 13 health facilities in six States of Southern Nigeria. All newly diagnosed TB patients registered from March to October 2015 were screened for DM using current World Health Organisation guidelines. Overall, 2094 TB patients were evaluated, 196 (9.4%) were found to have DM. The prevalence of newly diagnosed DM was 5.5% (115/2094). DM prevalence varied according to age group; occurring in 2.2% of patients aged ≤ 25 years and 16.9% in patients aged (56–65) years. The additional yield of DM was 59% while the number needed to screen to detect a new case of DM was 18. Factors associated with DM were; age >40 years (aOR2.8, CI 2.1–3.9), rural residence (aOR2.3, 1.6–3.2), private health facility care (aOR2.0, 1.4–2.7), and having an occupation that engages in vigorous activity (aOR0.6, 0.4–0.9). The burden of DM among TB patients is high. Prioritization of DM screening for TB patients is indicated. PMID:28281682

  20. A multi-centre randomised controlled trial of rehabilitation aimed at improving outdoor mobility for people after stroke: Study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Logan Pip A

    2012-06-01

    Full Text Available Abstract Background Up to 42% of all stroke patients do not get out of the house as much as they would like. This can impede a person’s quality of life. This study is testing the clinical effectiveness and cost effectiveness of a new outdoor mobility rehabilitation intervention by comparing it to usual care. Methods/design This is a multi-centre parallel group individually randomised, controlled trial. At least 506 participants will be recruited through 15 primary and secondary care settings and will be eligible if they are over 18 years of age, have had a stroke and wish to get out of the house more often. Participants are being randomly allocated to either the intervention group or the control group. Intervention group participants receive up to 12 rehabilitation outdoor mobility sessions over up to four months. The main component of the intervention is repeated practice of outdoor mobility with a therapist. Control group participants are receiving the usual intervention for outdoor mobility limitations: verbal advice and provision of leaflets provided over one session. Outcome measures are being collected using postal questionnaires, travel calendars and by independent assessors. The primary outcome measure is the Social Function domain of the SF36v2 quality of life assessment six months after recruitment. The secondary outcome measures include: functional ability, mobility, the number of journeys (monthly travel diaries, satisfaction with outdoor mobility, mood, health-related quality of life, resource use of health and social care. Carer mood information is also being collected. The mean Social Function score of the SF-36v2 will be compared between treatment arms using a multiple membership form of mixed effects multiple regression analysis adjusting for centre (as a fixed effect, age and baseline Social Function score as covariates and therapist as a multiple membership random effect. Regression coefficients and 95% confidence

  1. Determinants of Attrition to Follow-Up in a Multicentre Cohort Study in Children-Results from the IDEFICS Study

    DEFF Research Database (Denmark)

    Hense, Sabrina; Pohlabeln, Hermann; Michels, Nathalie;

    2013-01-01

    at 훼 = 0 . 0 1 to account for the large sample size. The strongest associations were seen for baseline item non-response, especially when information on migration background (odds ratio (OR) = 1.55; 99% confidence interval (CI): 1.04, 2.31), single parenthood (OR = 1.37; 99% CI: 1.12, 1.67), or well......-being (OR = 1.46; 99% CI: 1.19, 1.79) was lacking. Drop-out proportion rose with the number of missing items. Overweight, low education, single parenthood and low well-being scores were independent determinants of attrition. Baseline participation, and the individual determinant effects seemed unrelated......Cohort participant retention is a crucial element and may depend on several factors. Based on data from a multicentre cohort of European children, the effect of baseline participation on attrition and the association with and the impact of single determinants in relation to the extent of attrition...

  2. Parental height and child growth from birth to 2 years in the WHO Multicentre Growth Reference Study.

    Science.gov (United States)

    Garza, Cutberto; Borghi, Elaine; Onyango, Adelheid W; de Onis, Mercedes

    2013-09-01

    Linear growth from birth to 2 years of children enrolled in the World Health Organization Multicentre Growth Reference Study was similar despite substantial parental height differences among the six study sites. Within-site variability in child length attributable to parental height was estimated by repeated measures analysis of variance using generalized linear models. This approach was also used to examine relationships among selected traits (e.g. breastfeeding duration and child morbidity) and linear growth between 6 and 24 months of age. Differences in intergenerational adult heights were evaluated within sites by comparing mid-parental heights (average of the mother's and father's heights) to the children's predicted adult height. Mid-parental height consistently accounted for greater proportions of observed variability in attained child length than did either paternal or maternal height alone. The proportion of variability explained by mid-parental height ranged from 11% in Ghana to 21% in India. The average proportion of between-child variability accounted for by mid-parental height was 16% and the analogous within-child estimate was 6%. In the Norwegian and US samples, no significant differences were observed between mid-parental and children's predicted adult heights. For the other sites, predicted adult heights exceeded mid-parental heights by 6.2-7.8 cm. To the extent that adult height is predicted by height at age 2 years, these results support the expectation that significant community-wide advances in stature are attainable within one generation when care and nutrition approximate international recommendations, notwithstanding adverse conditions likely experienced by the previous generation.

  3. Is lesional stability in vitiligo more important than disease stability for performing surgical interventions? results from a multicentric study

    Directory of Open Access Journals (Sweden)

    Imran Majid

    2016-01-01

    Full Text Available Background: Ensuring stability of the disease process is essential for undertaking surgical intervention in vitiligo. However, there is no consensus regarding the minimum duration of stability or the relative importance of disease and lesional stability in selecting patients for vitiligo grafting. Aim: This multicentric study aims to assess the relative importance of lesional and disease stability on selecting patients for vitiligo grafting. Materials and Methods: One hundred seventy patients were recruited into the study and divided into two groups: Group A with lesional stability of >1 year but overall disease stability of only 6-11 months and Group B with overall disease stability of >1 year. Patients underwent either tissue or cellular vitiligo grafting on the selected lesions and the repigmentation achieved was scored from 0 (no repigmentation to 6 (100% repigmentation. Repigmentation achieved on different sites of the body was compared between the two groups. Adverse effects at both the donor and the recipient sites were also compared. Results: Of the 170 patients who were enrolled, 82 patients were placed in Group A and 88 patients in Group B. Average repigmentation achieved (on scale of 0 to 6 was 3.8 and 4.04 in Group A and Group B, respectively. In Group A, ≥90% repigmentation was achieved in 36.6% (30/82 patients, while 37.5% (33/88 achieved similar results in Group B. Additionally, 47.6% (39/82 and 53.4% (47/88 of cases achieved partial repigmentation in Group A and Group B, respectively. Perigraft halo was the commonest adverse effect observed in both groups. Statistical analysis revealed no significant differences between the two groups with respect to the repigmentation achieved or adverse effects observed. Repigmentation achieved was the best on the face and neck area, while acral areas responded the least. Conclusions: Lesional stability seems to be as relevant as the overall disease stability in selecting patients for

  4. The outcome of fistulotomy for anal fistula at 1 year: a prospective multicentre French study.

    Science.gov (United States)

    Abramowitz, L; Soudan, D; Souffran, M; Bouchard, D; Castinel, A; Suduca, J M; Staumont, G; Devulder, F; Pigot, F; Ganansia, R; Varastet, M

    2016-03-01

    The study aimed to evaluate outcome at 1 year of one- and two-stage fistulotomy for anal fistula in a large group of patients. A prospective multicentre observational study was designed to include patients with anal fistula treated by one- or two-stage fistulotomy. Data were collected using a self-administered questionnaire before surgery, during healing and at 1 year after surgery. Group A (133 patients) with a low anal fistula underwent a one-stage fistulotomy. The median Wexner scores before and after surgery were 1.0 (0-11) and 2.0 (0-18) (P = 0.032) and the median Vaizey scores were 2.0 (0-14) and 3.0 (0-21) (P = 0.055). The Wexner scores and percentage of patients before and after fistulotomy were as follows: 0-5: 88%, 86%; 6-10: 10.7%, 10.7%; 11-15: 1.0%, 2.6%; and 16-20: 0%, 2%. Eighty-seven per cent of the patients were satisfied. Group B (62 patients) underwent two-stage fistulotomy for a high transsphincteric fistula. The Wexner scores and percentage of patients before the first stage and 1 year after the second stage were as follows: 0-5: 86%, 66%; 6-10: 4.5%, 20%; 11-15: 9%, 11%; and 16-20: 0%, 2%. The median Wexner scores before the first stage and after the second stage were 1 (0-14) vs. 4 (0-19) (P fistula can be treated by fistulotomy without clinically significant continence disturbance. Treating high transsphincteric anal fistulae with two-stage fistulotomy is followed by mild continence disturbance. Satisfaction rates were high. Colorectal Disease © 2015 The Association of Coloproctology of Great Britain and Ireland.

  5. Assessment and validation of prognostic models for poor functional recovery 12 months after whiplash injury: a multicentre inception cohort study.

    Science.gov (United States)

    Sterling, Michele; Hendrikz, Joan; Kenardy, Justin; Kristjansson, Eythor; Dumas, Jean-Pierre; Niere, Ken; Cote, Julie; Deserres, Sophie; Rivest, Karine; Jull, Gwendolen

    2012-08-01

    Uncertainty surrounds prognostic factors after whiplash injury. Previously we identified a prognostic model for 6-month pain-related disability in a cohort of 80 participants with acute whiplash. Predictors included initial disability, older age, decreased cold pain thresholds, decreased neck rotation movement, posttraumatic stress symptoms and decreased sympathetic vasoconstriction. The objective of this study was to externally validate this model. In a multicentre inception cohort study, 286 participants with acute whiplash (I, II or III) were assessed at <3 weeks and 12 months after injury. The Neck Disability Index (NDI) was the outcome. Observed and predicted NDI scores were generated using the published equation of the original model. Model discrimination between participants with no or mild disability from those with moderate to severe disability was examined by receiver operating characteristic curves. Initial NDI and cold pain threshold predicted current observed 12-month NDI scores (r(2) = 0.50, 95% confidence interval 0.42 to 0.58). There was a significant site effect, and the estimated marginal mean ± SE of 12-month NDI for Iceland (27.6 ± 1.79%) was higher than the other 3 sites (Melbourne 11.2 ± 5.03%, Canada 16.4 ± 2.36%, Brisbane 16.8 ± 1.17%). After adjusting for site, age and Impact of Events Scale scores regained significance (r(2) = 0.56, 95% confidence interval 0.48 to 0.64). The tested model was not precise in predicting NDI as a continuous variable. However, it found good accuracy to discriminate participants with moderate to severe disability at 12 months (area under the receiver operating characteristic curve 0.89 [95% confidence interval 0.84-0.94], P<.001) which is clinically useful.

  6. Multicentre study highlighting clinical relevance of new high-throughput methodologies in molecular epidemiology of Pneumocystis jirovecii pneumonia.

    Science.gov (United States)

    Esteves, F; de Sousa, B; Calderón, E J; Huang, L; Badura, R; Maltez, F; Bassat, Q; de Armas, Y; Antunes, F; Matos, O

    2016-06-01

    Pneumocystis jirovecii causes severe interstitial pneumonia (PcP) in immunosuppressed patients. This multicentre study assessed the distribution frequencies of epidemiologically relevant genetic markers of P. jirovecii in different geographic populations from Portugal, the USA, Spain, Cuba and Mozambique, and the relationship between the molecular data and the geographical and clinical information, based on a multifactorial approach. The high-throughput typing strategy for P. jirovecii characterization consisted of DNA pooling using quantitative real-time PCR followed by multiplex-PCR/single base extension. The frequencies of relevant P. jirovecii single nucleotide polymorphisms (mt85, SOD110, SOD215, DHFR312, DHPS165 and DHPS171) encoded at four loci were estimated in ten DNA pooled samples representing a total of 182 individual samples. Putative multilocus genotypes of P. jirovecii were shown to be clustered due to geographic differences but were also dependent on clinical characteristics of the populations studied. The haplotype DHFR312T/SOD110C/SOD215T was associated with severe AIDS-related PcP and high P. jirovecii burdens. The frequencies of this genetic variant of P. jirovecii were significantly higher in patients with AIDS-related PcP from Portugal and the USA than in the colonized patients from Portugal, and Spain, and children infected with P. jirovecii from Cuba or Mozambique, highlighting the importance of this haplotype, apparently associated with the severity of the disease and specific clinical groups. Patients from the USA and Mozambique showed higher rates of DHPS mutants, which may suggest the circulation of P. jirovecii organisms potentially related with trimethoprim-sulfamethoxazole resistance in those geographical regions. This report assessed the worldwide distribution of P. jirovecii haplotypes and their epidemiological impact in distinct geographic and clinical populations.

  7. Non-adherence to subcutaneous biological medication in patients with rheumatoid arthritis: a multicentre, non-interventional study.

    Science.gov (United States)

    Calvo-Alén, Jaime; Monteagudo, Indalecio; Salvador, Georgina; Vázquez-Rodríguez, Tomás R; Tovar-Beltrán, Juan V; Vela, Paloma; Maceiras, Francisco; Bustabad, Sagrario; Román-Ivorra, José A; Díaz-Miguel, Consuelo; Rosas, José; Raya, Enrique; Carmona, Loreto; Cea-Calvo, Luis; Arteaga, María J; Fernández, Sabela; Marras, Carlos

    2017-01-01

    To evaluate non-adherence to prescribed subcutaneous biologicals in rheumatoid arthritis (RA) patients in Spain. ARCO (Study on Adherence of Rheumatoid Arthritis patients to SubCutaneous and Oral Drugs) was a multicentre, non-interventional retrospective study involving 42 rheumatology clinics from representative hospitals throughout Spain. The primary objective was to assess the percentage of patients (aged ≥18 years with an established RA diagnosis) with non-adherence to prescribed subcutaneous biologicals using clinical records and hospital pharmacy dispensing logs as the primary information sources. Adherence was assessed using the Medication Possession Ratio (MPR). Additionally, patients completed the Morisky-Green Medication Adherence Questionnaire. A total of 364 patients (77.5% females, mean age 54.9 years, median RA duration since diagnosis 7.8 years) were enrolled in ARCO. Non-adherence (MPR ≤80%) was reported in 52/363 evaluable patients (14.3%), and was lower in patients receiving initial monthly drug administration (6.4%) than with weekly (17.4%; p=0.034) or every two weeks (14.4%; p=0.102) administration. By multivariate analysis, non-adherence was positively associated with RA duration above the median and with using induction doses. Monthly administration, compared to weekly administration, was inversely associated with non-adherence. Age, gender, order of administration, and changes in the interval of administration, showed no association with non-adherence. Compared with the MPR, the Morisky-Green questionnaire performed poorly in detecting non-adherence. Non-adherence to the prescribed subcutaneous biological drug occurred in 14.3% of patients with RA. Patients using the most convenient administration period (i.e. monthly) had better adherence than those using more frequent dosing schedules.

  8. A Multicentre Study of CLa Implant and Sino-implant Expanded Application (two-year follow-up)

    Institute of Scientific and Technical Information of China (English)

    方可娟; 关艳敏; 范慧民; 高尔生; 杨丹; 薜丽; 韩耀玲; 刘宝

    1997-01-01

    A multicentre comparative clinical study of CLa implant and Sino-implant was carried out at 100 subcentres in 11 provinces, and a total of 19673 subjects were recruited. Two year follow up has been finished. The follow-up rate at the end of two years was 94,29%. Two-year cumulative continuation rate per 100 women for Sino-implant(89.93) was significantly higher than that for CLa implant (88.89). Two-year cumulative pregnancy rates per 100 women were 0.0462(CLa implant) and 0.281(Sino-implant) respectively; there was statistically significant difference between them. No ectopic pregnancy was recorded among CLa implant users and three ectopic pregnancies were reported among Sino implant users,resulting in an ectopic pregnancy rate of 0.163 per 1000 women years. The incidence of side-effects appeared to diminish with time. The major side effects were the menstrual disturbances, which accounted for more than 90% of the total sideeffects, and the incidence of frequent menstruation, irregular bleeding and spotring was higher than that of infrequentjscanty menstruation and amenorrhea. Use of CLa implant had higher incidence of amenorrhea and infrequentjscanty menstruation than that of Sin-imptant. During two-year follow-up, the number of discontinuation due to menstrual problems contributed 78% of the total number of discontinuation; two year menstrual-related cumulative discontinuation rates were 8.96 per 100 women for CLa implant and 7.84 for Sino-implant; there was statistically significant difference(P< 0.01). Two-year study shows that the two types of implant are similar to Norplant in the incidence of side-effects and contraceptive efficacy as well as two year continuation rates.

  9. Effect of educational intervention on antibiotic prescription practices for upper respiratory infections in children: a multicentre study.

    Science.gov (United States)

    Razon, Yaron; Ashkenazi, Shai; Cohen, Avner; Hering, Eli; Amzel, Shlomo; Babilsky, Hanan; Bahir, Arie; Gazala, Eli; Levy, Itzhak

    2005-11-01

    To evaluate the impact of an educational intervention on judicious antibiotic prescription for upper respiratory diseases in children. A multicentre before-and-after study was conducted in five major community child healthcentres in Israel. Antibiotic prescription data were collected for all visits of patients aged 3 months to 18 years with a diagnosis of acute otitis media, tonsillopharyngitis, sinusitis or upper respiratory tract infection from November 1999 through February 2000 (pre-intervention period) and from November 2000 through February 2001 (post-intervention period). The intervention consisted of a 1 day seminar on the diagnosis and judicious treatment of respiratory tract infections in children according to the recommendations of the Centers of Disease Control and Prevention. The patient files were reviewed for patient characteristics, specific respiratory disease, and specific antibiotics prescribed. The main outcome measures were the rates and appropriateness of antibiotic prescribing for the different respiratory diseases before and after an educational intervention for practising paediatricians. A total of 4580 clinic visits were eligible for analysis in the pre-intervention period and 4364 in the post-intervention period. From the pre- to the post-intervention period, the odds ratio for appropriate antibiotic treatment was 1.8 for acute otitis media (95% CI 1.52-2.11, P < 0.01) and 1.35 for pharyngitis (95% CI 1.13-1.61, P < 0.01). Overall, use of antibiotics for acute otitis media decreased from 93% to 87.4% (P < 0.05), and for upper respiratory tract infection, from 13.8% to 11.5% (P < 0.05). There were no significant changes in these factors for sinusitis. A targeted educational intervention can improve antibiotic prescription practices for respiratory infections in children and decrease unnecessary antibiotic use. Such studies can also pinpoint areas that require further attention.

  10. Combined treatment with low-dose methotrexate and initial short-term superpotent topical steroids in bullous pemphigoid: an open, multicentre, retrospective study.

    Science.gov (United States)

    Du-Thanh, A; Merlet, S; Maillard, H; Bernard, P; Joly, P; Estève, E; Richard, M A; Pauwels, C; Ingen-Housz-Oro, S; Guillot, B; Dereure, O

    2011-12-01

    The interest of long-term superpotent topical steroids (STS) in bullous pemphigoid (BP) has been supported by randomized controlled trials. However, inadequate compliance, poor cutaneous tolerance and nursing difficulties are potential drawbacks. Open-label studies on limited series of patients suggested that low-dose methotrexate (MTX) may be useful, permitting long-term maintenance of a clinical remission obtained by initial, short-term STS. Open, clinical records-based retrospective analysis of a multicentre series of patients receiving a combined regimen of initial, short-term STS and MTX followed by long-term MTX alone. The primary objective was evaluation of the clinical efficiency of this strategy based on initial clinical remission and subsequent clinical maintenance. The secondary objective was evaluation of the tolerance (type and rating of adverse events) of this combined regimen. Seventy patients with BP (mean age 82·7 years) were included. Treatment consisted of an initial combination of STS and MTX for a mean duration of 12·3 weeks followed by long-term MTX alone for a mean duration of 8·48 months with a mean and median MTX dosage of 10 mg per week. One hundred per cent of the patients showed an initial, complete clinical remission after a mean time interval of 21·9 days. The overall rate of long-term disease control was 76%, whereas 24% of patients experienced at least one relapse during subsequent treatment with MTX alone. Drug-related adverse effects were mainly haematological and gastrointestinal and resulted in treatment discontinuation in 11 patients (16%). Six patients (9%) died during the follow-up period with one death (1%) most likely to be related to treatment. Long-term low-dose MTX combined with short-term STS may result in protracted control of BP in carefully selected patients. These results should prompt randomized controlled trials comparing this treatment with the more usual regimen of long-term STS alone. © 2011 The Authors

  11. Entecavir plus tenofovir combination therapy in patients with multidrug-resistant chronic hepatitis B: results of a multicentre, prospective study.

    Science.gov (United States)

    Park, Jun Yong; Kim, Chang Wook; Bae, Si Hyun; Jung, Kyu Sik; Kim, Hee Yeon; Yoon, Seung Kew; Han, Kwang-Hyub; Ahn, Sang Hoon

    2016-08-01

    Sequential therapy posed a high risk of emergence of multidrug resistance and presented a management issue in chronic hepatitis B (CHB) treatment. We evaluated the antiviral efficacy and safety of entecavir (ETV) plus tenofovir (TDF) combination therapy in multidrug-resistant (MDR) CHB patients. In this prospective, multicentre study, MDR CHB patients, defined as measurable serum HBV DNA (≥60 IU/ml) while on any rescue treatment regimen for at least 24 weeks and the presence of documented prior genotypic resistance to both nucleoside analogue(s) and nucleotide analogue, were treated with ETV 1.0 mg and TDF 300 mg combination therapy for 48 weeks. A total of 64 eligible patients who had previously failed to a median three lines of antiviral therapy (range, 2-6) were included. At baseline, median age was 47.0 years, 89.1% were HBeAg(+), and median HBV DNA was 4.24 (range, 2.11-6.73) log10 IU/ml. By week 4, 12, 24 and 48, 15/64 (23.4%), 36/64 (56.3%), 43/64 (67.2%) and 55/64 (85.9%) patients achieved a HBV DNA <60 IU/ml respectively. The mean reduction of HBV DNA from baseline to 4 and 48 weeks was 1.23 log10 IU/ml and 2.38 log10 IU/ml respectively. Although five patients experienced virological breakthrough, all were transient and no resistant mutation to TDF or novel mutation was detected in any patients. In difficult-to-treat MDR CHB patients with a high exposure to multiple antiviral drugs, ETV plus TDF combination therapy can provide a very high rate of viral suppression through 48 weeks of treatment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    Directory of Open Access Journals (Sweden)

    Stefanie L De Buyser

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

  13. 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.

  14. Assessment of apixaban plasma levels by laboratory tests: suitability of three anti-Xa assays. A multicentre French GEHT study.

    Science.gov (United States)

    Gouin-Thibault, Isabelle; Flaujac, Claire; Delavenne, Xavier; Quenet, Sara; Horellou, Marie-Hélenè; Laporte, Silvy; Siguret, V; Lecompte, T

    2014-02-01

    While laboratory monitoring is not required in patients treated with apixaban, a direct factor-Xa inhibitor, assessment of its concentration is useful in some critical situations. However, few data are available on its effect on coagulation tests and on the suitability of anti-Xa assays for its quantification. It was the objective of this study to identify laboratory tests suitable for apixaban concentration assessment. Coagulation tests - PT and aPTT- and anti-Xa assays were performed in apixaban-spiked plasma samples. To evaluate the sensitivity of PT and aPTT to apixaban, we conducted a first monocenter part, with a wide range of concentrations (50-1,000 ng/ml), a large panel of reagents (20 reagents), and two coagulometers (STAR®, Stago and ACL TOP®, IL), and a second multicenter part involving 13 laboratories using either a common PT reagent (RecombiPlastin2G®) or the local PT and aPTT reagents. In the multicentre part, five blinded apixaban-spiked plasma samples (0/100/200/400/800 ng/ml - checked by HPLC-MS/MS) were used; apixaban concentrations were measured with three anti-Xa assays, apixaban calibrators and controls (Stago). PT and aPTT tests using a large panel of reagents displayed a low sensitivity to a wide range of apixaban concentrations. The concentrations to double PT ranged from 400 to >1,000 ng/ml with the 10 reagents. With the three anti-Xa assays, inter-laboratory precision and accuracy were below 11% and 12%, respectively. In conclusion, whereas PT and aPTT tests were not sensitive enough to detect apixaban, the three anti-Xa assays tested using lyophilised apixaban calibrators and controls allowed to reliably quantify a wide range of apixaban concentrations.

  15. Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.

    Science.gov (United States)

    Friedl, Alexander; Mühlstädt, Sandra; Zachoval, Roman; Giammò, Alessandro; Kivaranovic, Danijel; Rom, Maximilian; Fornara, Paolo; Brössner, Clemens

    2017-05-01

    To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS(®) , Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting. In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

  16. Prevalence of thrombocytosis in critically ill patients and its association with symptomatic acute pulmonary embolism. A multicentre registry study.

    Science.gov (United States)

    Ho, Kwok M; Chavan, Shaila

    2013-02-01

    It is uncertain whether thrombocytosis without underlying myeloproliferative diseases is associated with an increased risk of acute pulmonary embolism (PE). We investigated the relationship between thrombocytosis and risk of symptomatic acute PE, and whether Pulmonary Embolism Severity Index (PESI) was reliable in predicting mortality of acute PE. This multicentre registry study involved a total of 609,367 critically ill patients admitted to 160 intensive care units (ICUs) in Australia or New Zealand between 2006 and 2011. Forward stepwise logistic regression was used to assess the relationship between risk of acute PE and platelet counts on intensive care unit (ICU) admission. Acute PE (n=3387) accounted for 0.9% of all emergency ICU admissions. Over 20% of all PE required mechanical ventilation, 4.2% had cardiac arrest, and the mortality was high (14.8%). Thrombocytosis, defined by a platelet count >500x10⁹ per litre, occurred in 2.1% of the patients and was more common in patients with acute PE than other diagnoses (3.4 vs. 2.0%). The platelet counts explained about 4.5% of the variability and had a linear relationship with the risk of acute PE (odds ratio 1.19 per 100x10⁹ per litre increment in platelet count, 95% confidence interval 1.06-1.34), after adjusting for other covariates. The PESI had a reasonable discriminative ability (area under receiver-operating-characteristic curve = 0.78) and calibration to predict mortality across a wide range of severity of acute PE. In summary, thrombocytosis was associated with an increased risk of symptomatic acute PE. PESI was useful in predicting mortality across a wide range of severity of acute PE.

  17. Multi-centre evaluation of accuracy and reproducibility of planar and SPECT image quantification. An IAEA phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Zimmermann, Brian E. [National Institute of Standards and Technology, Gaithersburg, MD (United States); Grosev, Darko [Univ. Hospital Centre Zagreb (Croatia); Buvat, Irene [Service Hospitalier Frederic Joliot, Paris (France); and others

    2017-08-01

    Accurate quantitation of activity provides the basis for internal dosimetry of targeted radionuclide therapies. This study investigated quantitative imaging capabilities at sites with a variety of experience and equipment and assessed levels of errors in activity quantitation in Single-Photon Emission Computed Tomography (SPECT) and planar imaging. Participants from 9 countries took part in a comparison in which planar, SPECT and SPECT with X ray computed tomography (SPECT-CT) imaging were used to quantify activities of four epoxy-filled cylinders containing {sup 133}Ba, which was chosen as a surrogate for {sup 131}I. The sources, with nominal volumes of 2, 4, 6 and 23 mL, were calibrated for {sup 133}Ba activity by the National Institute of Standards and Technology, but the activity was initially unknown to the participants. Imaging was performed in a cylindrical phantom filled with water. Two trials were carried out in which the participants first estimated the activities using their local standard protocols, and then repeated the measurements using a standardized acquisition and analysis protocol. Finally, processing of the imaging data from the second trial was repeated by a single centre using a fixed protocol. In the first trial, the activities were underestimated by about 15% with planar imaging. SPECT with Chang's first order attenuation correction (Chang-AC) and SPECT-CT overestimated the activity by about 10%. The second trial showed moderate improvements in accuracy and variability. Planar imaging was subject to methodological errors, e.g., in the use of a transmission scan for attenuation correction. The use of Chang-AC was subject to variability from the definition of phantom contours. The project demonstrated the need for training and standardized protocols to achieve good levels of quantitative accuracy and precision in a multicentre setting. Absolute quantification of simple objects with no background was possible with the strictest protocol to

  18. [Yeast urinary tract infections. Multicentre study in 14 hospitals belonging to the Buenos Aires City Mycology Network].

    Science.gov (United States)

    Maldonado, Ivana; Arechavala, Alicia; Guelfand, Liliana; Relloso, Silvia; Garbasz, Claudia

    2016-01-01

    Urinary tract infections are a frequent ailment in patients in intensive care units. Candida and other yeasts cause 5-12% of these infections. The value of the finding of any yeast is controversial, and there is no consensus about which parameters are adequate for differentiating urinary infections from colonization or contamination. To analyse the epidemiological characteristics of patients with funguria, to determine potential cut-off points in cultures (to distinguish an infection from other conditions), to identify the prevalent yeast species, and to determine the value of a second urine sample. A multicentre study was conducted in intensive care units of 14 hospitals in the Buenos Aires City Mycology Network. The first and second samples of urine from every patient were cultured. The presence of white cells and yeasts in direct examination, colony counts, and the identification of the isolated species, were evaluated. Yeasts grew in 12.2% of the samples. There was no statistical correlation between the number of white cells and the fungal colony-forming units. Eighty five percent of the patients had indwelling catheters. Funguria was not prevalent in women or in patients over the age of 65. Candida albicans, followed by Candida tropicalis, were the most frequently isolated yeasts. Candida parapsilosis and Candida glabrata appeared less frequently. The same species were isolated in 70% of second samples, and in 23% of the cases the second culture was negative. It was not possible to determine a useful cut-off point for colony counts to help in the diagnosis of urinary infections. As in other publications, C. albicans, followed by C. tropicalis, were the most prevalent species. Copyright © 2015 Asociación Española de Micología. Published by Elsevier Espana. All rights reserved.

  19. Cross-centre replication of suppressed burrowing behaviour as an ethologically relevant pain outcome measure in the rat: a prospective multicentre study

    Science.gov (United States)

    Wodarski, Rachel; Delaney, Ada; Ultenius, Camilla; Morland, Rosie; Andrews, Nick; Baastrup, Catherine; Bryden, Luke A.; Caspani, Ombretta; Christoph, Thomas; Gardiner, Natalie J.; Huang, Wenlong; Kennedy, Jeffrey D.; Koyama, Suguru; Li, Dominic; Ligocki, Marcin; Lindsten, Annika; Machin, Ian; Pekcec, Anton; Robens, Angela; Rotariu, Sanziana M.; Voß, Sabrina; Segerdahl, Marta; Stenfors, Carina; Svensson, Camilla I.; Treede, Rolf-Detlef; Uto, Katsuhiro; Yamamoto, Kazumi; Rutten, Kris; Rice, Andrew S.C.

    2016-01-01

    Abstract Burrowing, an ethologically relevant rodent behaviour, has been proposed as a novel outcome measure to assess the global impact of pain in rats. In a prospective multicentre study using male rats (Wistar, Sprague-Dawley), replication of suppressed burrowing behaviour in the complete Freund adjuvant (CFA)-induced model of inflammatory pain (unilateral, 1 mg/mL in 100 µL) was evaluated in 11 studies across 8 centres. Following a standard protocol, data from participating centres were collected centrally and analysed with a restricted maximum likelihood-based mixed model for repeated measures. The total population (TP—all animals allocated to treatment; n = 249) and a selected population (SP—TP animals burrowing over 500 g at baseline; n = 200) were analysed separately, assessing the effect of excluding “poor” burrowers. Mean baseline burrowing across studies was 1113 g (95% confidence interval: 1041-1185 g) for TP and 1329 g (1271-1387 g) for SP. Burrowing was significantly suppressed in the majority of studies 24 hours (7 studies/population) and 48 hours (7 TP, 6 SP) after CFA injections. Across all centres, significantly suppressed burrowing peaked 24 hours after CFA injections, with a burrowing deficit of −374 g (−479 to −269 g) for TP and −498 g (−609 to −386 g) for SP. This unique multicentre approach first provided high-quality evidence evaluating suppressed burrowing as robust and reproducible, supporting its use as tool to infer the global effect of pain on rodents. Second, our approach provided important informative value for the use of multicentre studies in the future. PMID:27643836

  20. Lafutidine 10 mg versus Rabeprazole 20 mg in the Treatment of Patients with Heartburn-Dominant Uninvestigated Dyspepsia: A Randomized, Multicentric Trial

    Directory of Open Access Journals (Sweden)

    Bhupesh Dewan

    2011-01-01

    Full Text Available Background. Empirical therapy with antisecretory agents like PPIs and H2RAs has long been the traditional approach in the initial management of uninvestigated dyspepsia. Aim. The objective of the study was to examine relief of dyspepsia with lafutidine, a second-generation H2-RA, and rabeprazole and to compare their efficacy. Methods. This was a randomized, open, comparative trial in adult uninvestigated dyspeptic patients, who had at least moderate severity of symptoms, defined as a score of ≥4 on a 7-point global overall symptom (GOS scale, and were randomized to receive once daily either lafutidine 10 mg or rabeprazole 20 mg for 4 weeks. Results. A total of 236 patients were enrolled, out of which 194 patients were included in the analysis. At the end of week 4, a significant difference was observed for symptom relief (lafutidine 89.90% versus rabeprazole 65.26%, P<.01 and symptom resolution (lafutidine 70.71% versus rabeprazole 25.26%, P<.01. Both the drugs were well tolerated. Conclusion. Both lafutidine and rabeprazole provide symptom relief in patients with heartburn-dominant uninvestigated dyspepsia. The present study confirms the appropriateness of lafutidine as an empiric treatment and superior efficacy for primary care practice patients with dyspepsia.

  1. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

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    Jimenez Carmen

    2005-10-01

    Full Text Available Abstract Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. The patients will be randomised into two groups: 1 experimental (acupuncture + physiotherapy; 2 control (TENS-placebo + physiotherapy; the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA Scale

  2. Patterns and predictors of sitting time over ten years in a large population-based Canadian sample: Findings from the Canadian Multicentre Osteoporosis Study (CaMos

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    Klaus Gebel

    2017-03-01

    Full Text Available Our objective was to describe patterns and predictors of sedentary behavior (sitting time over 10 years among a large Canadian cohort. Data are from the Canadian Multicentre Osteoporosis Study, a prospective study of women and men randomly selected from the general population. Respondents reported socio-demographics, lifestyle behaviors and health outcomes in interviewer-administered questionnaires; weight and height were measured. Baseline data were collected between 1995 and 1997 (n = 9418; participation rate = 42%, and at 5- (n = 7648 and 10-year follow-ups (n = 5567. Total sitting time was summed across domain-specific questions at three time points and dichotomized into “low” (≤7 h/day and “high” (>7 h/day, based on recent meta-analytic evidence on time sitting and all-cause mortality. Ten-year sitting patterns were classified as “consistently high”, “consistently low”, “increased”, “decreased”, and “mixed”. Predictors of sedentary behavior patterns were explored using chi-square tests, ANOVA and logistic regression. At baseline (mean age = 62.1 years ± 13.4 average sitting was 6.9 h/day; it was 7.0 at 5- and 10-year follow-ups (p for trend = 0.12. Overall 23% reported consistently high sitting time, 22% consistently low sitting, 14% decreased sitting, 17% increased sitting with 24% mixed patterns. Consistently high sitters were more likely to be men, university educated, full-time employed, obese, and to report consistently low physical activity levels. This is one of the first population-based studies to explore patterns of sedentary behavior (multi-domain sitting within men and women over years. Risk classification of sitting among many adults changed during follow-up. Thus, studies of sitting and health would benefit from multiple measures of sitting over time.

  3. 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

  4. Association of tobacco use and other determinants with pregnancy outcomes: a multicentre hospital-based case–control study in Karachi, Pakistan

    Science.gov (United States)

    Rozi, Shafquat; Butt, Zahid Ahmad; Zahid, Nida; Wasim, Saba; Shafique, Kashif

    2016-01-01

    Objectives The study aimed to identify the effects of maternal tobacco consumption during pregnancy and other factors on birth outcomes and obstetric complications in Karachi, Pakistan. Design A multicentre hospital-based case–control study. Setting Four leading maternity hospitals of Karachi. Participants A random sample of 1275 women coming to the gynaecology and obstetric department of selected hospitals for delivery was interviewed within 48 hours of delivery from wards. Cases were women with adverse birth outcomes and obstetric complications, while controls were women who had normal uncomplicated delivery. Primary and secondary outcome measures Adverse birth outcomes (preterm delivery, low birth weight, stillbirth, low Apgar score) and obstetric complications (antepartum haemorrhage, caesarean section, etc). Results Final multiple logistic regression analysis revealed that with every 1 year increase in age the odds of being a case was 1.03 times as compared with being a control. Tobacco use (adjusted OR (aOR): 2.24; 95% CI 1.56 to 3.23), having no slits in the kitchen (proxy indicator for indoor air pollution) (aOR=1.90; 95% CI 1.05 to 3.43), gravidity (aOR=0.83; 95% CI 0.73 to 0.93), non-booked hospital cases (aOR=1.87; 95% CI 1.38 to 2.74), history of stillbirth (aOR=4.06; 95% CI 2.36 to 6.97), miscarriages (aOR=1.91; 95% CI 1.27 to 2.85) and preterm delivery (aOR=6.04; 95% CI 2.52 to 14.48) were significantly associated with being a case as compared with control. Conclusions This study suggests that women who had adverse pregnancy outcomes were more likely to have exposure to tobacco, previous history of adverse birth outcomes and were non-booked cases. Engagement of stakeholders in tobacco control for providing health education, incorporating tobacco use in women in the tobacco control policy and designing interventions for tobacco use cessation is warranted. Prenatal care and health education might help in preventing such adverse events. PMID

  5. Predictors of participation of adolescents with cerebral palsy: A European multi-centre longitudinal study.

    Science.gov (United States)

    Dang, Van Mô; Colver, Allan; Dickinson, Heather O; Marcelli, Marco; Michelsen, Susan I; Parkes, Jackie; Parkinson, Kathryn; Rapp, Marion; Arnaud, Catherine; Nystrand, Malin; Fauconnier, Jérôme

    2014-11-14

    We investigated whether childhood factors that are amenable to intervention (parenting stress, child psychological problems and pain) predicted participation in daily activities and social roles of adolescents with cerebral palsy (CP). We randomly selected 1174 children aged 8-12 years from eight population-based registers of children with CP in six European countries; 743 (63%) agreed to participate. One further region recruited 75 children from multiple sources. These 818 children were visited at home at age 8-12 years, 594 (73%) agreed to follow-up at age 13-17 years. We used the following measures: parent reported stress (Parenting Stress Index Short Form), their child's psychological difficulties (Strength and Difficulties Questionnaire) and frequency and severity of pain; either child or parent reported the child's participation (LIFE Habits questionnaire). We fitted a structural equation model to each of the participation domains, regressing participation in childhood and adolescence on parenting stress, child psychological problems and pain, and regressing adolescent factors on the corresponding childhood factors; models were adjusted for impairment, region, age and gender. Pain in childhood predicted restricted adolescent participation in all domains except Mealtimes and Communication (standardized total indirect effects β -0.05 to -0.18, 0.01

  6. Problem solving ability and repetition of deliberate self-harm: a multicentre study.

    NARCIS (Netherlands)

    McAuliffe, C.; Corcoran, P.; Keeley, H.S.; Arensman, E.; Bille Brahe, U.; Leio, de D.; Fekete, S.; Hawton, K.; Hjelmeland, H.; Kelleher, M.; Kerkhof, A.J.F.M.; Lonnqvist, J.; Michel, K.; Salander Renberg, E.; Schmidtke, A.; Heeringen, van K.; Wasserman, D.

    2006-01-01

    Background. While recent studies have found problem-solving impairments in individuals who engage in deliberate self-harm (DSH), few studies have examined repeaters and non-repeaters separately. The aim of the present study was to investigate whether specific types of problem-solving are associated

  7. Does cataract surgery alleviate poverty? Evidence from a multi-centre intervention study conducted in Kenya, the Philippines and Bangladesh.

    Directory of Open Access Journals (Sweden)

    Hannah Kuper

    Full Text Available BACKGROUND: Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. METHODOLOGY/PRINCIPAL FINDINGS: A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh. Poverty data (household per capita expenditure--PCE, asset ownership and self-rated wealth were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuity<6/24 in the better eye and age-sex matched controls with normal vision. Cases were offered free/subsidised cataract surgery. Approximately one year later participants were re-interviewed about poverty. 466 cases and 436 controls were examined at both baseline and follow-up (Follow up rate: 78% for cases, 81% for controls, of which 263 cases had undergone cataract surgery ("operated cases". At baseline, operated cases were poorer compared to controls in terms of PCE (Kenya: $22 versus £35 p = 0.02, Bangladesh: $16 vs $24 p = 0.004, Philippines: $24 vs 32 p = 0.0007, assets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68. There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. CONCLUSIONS/SIGNIFICANCE: This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may help to alleviate

  8. Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial

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    Adang Eddy

    2009-06-01

    Full Text Available Abstract Background Care for people with dementia and their informal caregivers is a challenging aim in healthcare. There is an urgent need for cost-effective support programs that prevent informal caregivers of people with dementia from becoming overburdened, which might result in a delay or decrease of patient institutionalization. For this reason, we have developed the Systematic Care Program for Dementia (SCPD. The SCPD consists of an assessment of caregiver's sense of competence and suggestions on how to deal with competence deficiencies. The efficiency of the SCPD will be evaluated in our study. Methods and design In our ongoing, cluster, randomized, single-blind, controlled trial, the participants in six mental health services in four regions of the Netherlands have been randomized per service. Professionals of the ambulatory mental health services (psychologists and social psychiatric nurses have been randomly allocated to either the intervention group or the control group. The study population consists of community-dwelling people with dementia and their informal caregivers (patient-caregiver dyads coming into the health service. The dyads have been clustered to the professionals. The primary outcome measure is the patient's admission to a nursing home or home for the elderly at 12 months of follow-up. This measure is the most important variable for estimating cost differences between the intervention group and the control group. The secondary outcome measure is the quality of the patient's and caregiver's lives. Discussion A novelty in the SCPD is the pro-active and systematic approach. The focus on the caregiver's sense of competence is relevant to economical healthcare, since this sense of competence is an important determinant of delay of institutionalization of people with dementia. The SCPD might be able to facilitate this with a relatively small cost investment for caregivers' support, which could result in a major decrease in

  9. Single daily dose of moxifloxacin versus ofloxacin plus metronidazole as a new treatment approach to uncomplicated pelvic inflammatory disease: a multicentre prospective randomized trial.

    Science.gov (United States)

    Aşicioğlu, Osman; Gungorduk, Kemal; Ozdemir, Aykut; Ertas, Ibrahim Egemen; Yildirim, Gökhan; Sanci, Muzaffer; Ark, Cemal

    2013-11-01

    To evaluate the efficacy and safety of moxifloxacin versus ofloxacin plus metronidazole in patients with uncomplicated pelvic inflammatory disease (uPID; defined as PID symptoms and signs, but no complications such as septicemia, perihepatitis, and tubo-ovarian abscess) in Turkey. This was a multicenter, prospective, randomized, parallel-group study conducted between June 2010 and March 2013 in four hospitals in Turkey. Women received a 14-day course of either oral moxifloxacin at 400mg once daily (n = 560) or oral ofloxacin at 400mg twice daily plus oral metronidazole at 500 mg twice daily (n = 543). A total of 1156 women were randomized to the study. Total compliance was achieved in 1103 patients. For the primary measure of efficacy (clinical cure), moxifloxacin showed no difference compared with ofloxacin plus metronidazole (445/560 [79.5%] vs. 449/543 [82.7%]; p = 0.172). Bacteriological cure rates were high and comparable between treatment arms (99/119 [83.2%] vs. 93/110 [84.5%]; p = 0.781). Drug-related adverse events occurred less frequently with moxifloxacin than with ofloxacin plus metronidazole (210/560 [37.5%] vs. 252/543 [46.4%]; p = 0.003). Furthermore, moxifloxacin treatment was lower in cost and achieved higher patient compliance compared with ofloxacin plus metronidazole (31.4 Euros vs. 23.4 Euros and 7/578 (1.2%) vs. 22/578 (3.8%), respectively; p = 0.005). In patients with uPID, once-daily moxifloxacin monotherapy was clinically and microbiologically as efficacious as twice-daily ofloxacin plus metronidazole therapy and was associated with fewer drug-related adverse events, lower patient non-compliance, and a lower treatment cost. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  10. A multicentre, double-blind, randomised, controlled, parallel-group study of the effectiveness of a pharmacist-acquired medication history in an emergency department

    Science.gov (United States)

    2013-01-01

    Background Admission to an emergency department (ED) is a key vulnerable moment when patients are at increased risk of medication discrepancies and medication histories are an effective way of ensuring that fewer errors are made. This study measured whether a pharmacist-acquired medication history in an ED focusing on a patient’s current home medication regimen, and available to be used by a doctor when consulting in the ED, would reduce the number of patients having at least 1 medication discrepancy related to home medication. Methods This multicentre, double-blind, randomised, controlled parallel-group study was conducted at 3 large teaching hospitals. Two hundred and seventy participants were randomly allocated to an intervention (n = 134) or a standard care (n = 136) arm. All consecutive patients >18 years old admitted through the ED were eligible. The intervention consisted of pharmacists conducting a standardised comprehensive medication history interview focusing on a patient’s current home medication regimen, prior to being seen by a doctor. Data recorded on the admission medication order form was available to be used by a doctor during consultation in the ED. The admission medication order form was given to doctors at a later stage in the control arm for them to amend prescriptions. The effect of the intervention was assessed primarily by comparing the number of patients having at least 1 admission medication discrepancy regarding medication being taken at home. Secondary outcomes concerned the characteristics and clinical severity of such medication discrepancies. Results The intervention reduced discrepancies occurring by 33% (p medication occurred most frequently (55.1%) and most discrepancies (42.7%) were judged to have the potential to cause moderate discomfort or clinical deterioration. Conclusions A pharmacist-acquired medication history in an ED focusing on a patient’s current home medication regimen available to be used by a doctor

  11. A multicentre weight loss study using a low-calorie diet over 8 weeks

    DEFF Research Database (Denmark)

    Papadaki, Angeliki; Linardakis, Manolis; Plada, Maria

    2013-01-01

    The efficacy of low-calorie diets (LCDs) has not been investigated in large-scale studies or among people from different regions, who are perhaps unaccustomed to such methods of losing weight. The aim of the present study was to investigate changes in obesity measures among overweight/obese adults...

  12. Computers and internet in dental education system of Kerala, South India: A multicentre study

    Directory of Open Access Journals (Sweden)

    Kanakath Harikumar

    2015-01-01

    Full Text Available Computers and internet have exerted a tremendous effect on dental education programs all over the world. A multicenter study was done to assess trends in computer and internet usage among the dental students and faculty members across the South Indian state, Kerala. A total of 347 subjects participated in the study. All participants were highly competent with the use of computers and internet. 72.3% of the study subjects preferred hard copy textbooks to PDF format books. 81.3% of the study subjects thought that internet was a useful adjunct to dental education. 73.8% of the study subjects opined that computers and internet could never be a replacement to conventional classroom teaching. Efforts should be made to provide greater infrastructure with regard to computers and internet such as Wi-Fi, free, unlimited internet access to all students and faculty members.

  13. The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study: protocol for an international multicentre randomised controlled trial.

    Science.gov (United States)

    Avidan, Michael S; Fritz, Bradley A; Maybrier, Hannah R; Muench, Maxwell R; Escallier, Krisztina E; Chen, Yulong; Ben Abdallah, Arbi; Veselis, Robert A; Hudetz, Judith A; Pagel, Paul S; Noh, Gyujeong; Pryor, Kane; Kaiser, Heiko; Arya, Virendra Kumar; Pong, Ryan; Jacobsohn, Eric; Grocott, Hilary P; Choi, Stephen; Downey, Robert J; Inouye, Sharon K; Mashour, George A

    2014-09-17

    Postoperative delirium is one of the most common complications of major surgery, affecting 10-70% of surgical patients 60 years and older. Delirium is an acute change in cognition that manifests as poor attention and illogical thinking and is associated with longer intensive care unit (ICU) and hospital stay, long-lasting cognitive deterioration and increased mortality. Ketamine has been used as an anaesthetic drug for over 50 years and has an established safety record. Recent research suggests that, in addition to preventing acute postoperative pain, a subanaesthetic dose of intraoperative ketamine could decrease the incidence of postoperative delirium as well as other neurological and psychiatric outcomes. However, these proposed benefits of ketamine have not been tested in a large clinical trial. The Prevention of Delirium and Complications Associated with Surgical Treatments (PODCAST) study is an international, multicentre, randomised controlled trial. 600 cardiac and major non-cardiac surgery patients will be randomised to receive ketamine (0.5 or 1 mg/kg) or placebo following anaesthetic induction and prior to surgical incision. For the primary outcome, blinded observers will assess delirium on the day of surgery (postoperative day 0) and twice daily from postoperative days 1-3 using the Confusion Assessment Method or the Confusion Assessment Method for the ICU. For the secondary outcomes, blinded observers will estimate pain using the Behavioral Pain Scale or the Behavioral Pain Scale for Non-Intubated Patients and patient self-report. The PODCAST trial has been approved by the ethics boards of five participating institutions; approval is ongoing at other sites. Recruitment began in February 2014 and will continue until the end of 2016. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement and popular media. The study is registered at clinicaltrials.gov, NCT01690988 (last updated March 2014). The

  14. Multicentre study of posaconazole delayed-release tablet serum level and association with hepatotoxicity and QTc prolongation.

    Science.gov (United States)

    Pettit, Natasha N; Miceli, Marisa H; Rivera, Christina G; Narayanan, Prasanna P; Perissinotti, Anthony J; Hsu, Meier; Delacruz, Jennifer; Gedrimaite, Zivile; Han, Zhe; Steinbeck, Jennifer; Pisano, Jennifer; Seo, Susan K; Paskovaty, Alla

    2017-08-01

    The association of posaconazole serum concentrations and toxicity is unclear. An assessment of whether levels obtained with the delayed-release tablet (DRT) formulation are correlated with abnormal liver function test (LFT) results and/or QTc prolongation was undertaken. This was a multicentre, retrospective, observational study of adult patients with cancer between 26 November 2013 and 14 November 2014. Patients were included if they received posaconazole DRT with a posaconazole level obtained between days 5 and 14. Clinical data, including demographics, hepatotoxic medications, posaconazole levels, LFTs and QTc intervals, were obtained. Association of factors with changes in LFTs and QTc prolongation was assessed using linear and logistic regression. One hundred and sixty-six study patients were included. The median posaconazole level was 1250 (range 110-4220) ng/mL and the median time until level was 6 (range 5-14) days. There was a statistically significant increase in AST ( P  <   0.001), ALT ( P  <   0.001), alkaline phosphatase (ALK) ( P  <   0.001), total bilirubin (TBILI) ( P  <   0.001) and QTc ( P  =   0.05) from baseline. Posaconazole levels were not associated with increases in AST [β (SE) = -0.33 (2.2), P  =   0.88], log ALT [β (SE) = -0.02 (0.03), P  =   0.63], ALK [β (SE) = 2.2 (2.9), P  =   0.46] and TBILI [β (SE) = -0.01 (0.04), P  =   0.88]. For each additional hepatotoxic medication, there was a mean change in TBILI of 0.13 mg/dL ( P  =   0.02) and ALK of 7.1 U/L ( P  =   0.09). No statistically significant association between posaconazole level and QTc interval prolongation was found. We did not identify an association between posaconazole serum concentrations and LFT elevations or QTc prolongation. However, some LFTs were found to increase with more hepatotoxic medications administered.

  15. Characterization of methicillin-susceptible and -resistant staphylococci in the clinical setting: a multicentre study in Nigeria

    Directory of Open Access Journals (Sweden)

    Shittu Adebayo

    2012-11-01

    Full Text Available Abstract Background The staphylococci are implicated in a variety of human infections; however, many clinical microbiology laboratories in Nigeria do not identify staphylococci (in particular coagulase negative staphylococci - CNS to the species level. Moreover, data from multi-centre assessment on antibiotic resistance and epidemiology of the staphylococci are not available in Nigeria. This study investigated 91 non-duplicate staphylococcal isolates obtained from the microbiology laboratories of eight hospitals in Nigeria during the period January to April 2010. Methods Identification and antibiotic susceptibility testing was performed using the VITEK 2 system, detection of resistance genes by PCR, and molecular characterization was determined by SCCmec typing, spa and multilocus sequence typing (MLST. Results All the isolates were susceptible to mupirocin, tigecycline, vancomycin and linezolid, but 72.5% of CNS and 82.3% of Staphylococcus aureus were resistant to cotrimoxazole, while multiresistance was observed in 37 of the 40 CNS isolates. Untypeable SCCmec types (ccrC/Class A mec and ccr-negative/Class C2 mec gene complex in two methicillin-resistant S. aureus (MRSA were identified. Additionally, ccr-negative/Class A mec and ccr type 4/Class C2 mec gene complex was detected in one isolate each of S. sciuri and S. haemolyticus, respectively. The S. aureus isolates were classified into 21 spa types including two new types (t8987, t9008 among the methicillin-susceptible S. aureus (MSSA isolates. Two (CC8-SCCmecnon-typeable and CC88-SCCmec IV and four (CC8-SCCmec III/IV/V; CC30-SCCmec II/III; CC88-SCCmec IV; and ST152-SCCmecnon-typeable MRSA clones were identified in Maiduguri (North-East Nigeria and South-West Nigeria, respectively. The proportion of Panton-Valentine leukocidin (PVL-positive MSSA was high (44.4% and 56.3% of these strains were associated with sequence type (ST 152. Conclusions The identification of multiresistant mecA positive

  16. Evaluation of Clensia(®), a new low-volume PEG bowel preparation in colonoscopy: Multicentre randomized controlled trial versus 4L PEG.

    Science.gov (United States)

    Spada, Cristiano; Cesaro, Paola; Bazzoli, Franco; Saracco, Giorgio Maria; Cipolletta, Livio; Buri, Luigi; Crosta, Cristiano; Petruzziello, Lucio; Ceroni, Liza; Fuccio, Lorenzo; Giordanino, Chiara; Elia, Chiara; Rotondano, Gianluca; Bianco, Maria A; Simeth, Catrin; Consalvo, Danilo; De Roberto, Giuseppe; Fiori, Giancarla; Campanale, Mariachiara; Costamagna, Guido

    2017-06-01

    Success of colonoscopy is linked to the adequacy of bowel cleansing. Polyethylene glycol 4L (PEG 4L) solutions are widely used for colonic cleansing but with limitations concerning tolerability and acceptability. To demonstrate the equivalence of a new low-volume PEG containing citrates and simeticone (Clensia) versus a standard PEG 4L. In this, multicentre, randomised, observer-blind trial, patients received either Clensia 2L or PEG 4L solution. Primary endpoint was the proportion of patients with colon cleansing evaluated as excellent or good. 422 patients received Clensia (n=213) or PEG 4L (n=209). Rate of excellent/good bowel cleansing was 73.6% and 72.3% in Clensia and PEG 4L group respectively. Clensia was demonstrated to be equivalent to PEG 4L. No SAEs were observed. Clensia showed better gastrointestinal tolerability (37.0% vs 25.4%). The acceptability was significantly better with Clensia in terms of proportion of subjects who felt no distress (Clensia 72.8% vs PEG 4L 63%, P=0.0314) and willingness-to-repeat (93.9% vs 82.2%, P=0.0002). The rate of optimal compliance was similar with both formulations (91.1% for Clensia vs 90.9% for PEG 4L, P=0.9388). The low-volume Clensia is equally effective and safe in bowel cleansing compared to the standard PEG 4L, with better gastrointestinal tolerability and acceptability. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  17. A Multicentre, Observational Study of Sodium Picosulfate and Magnesium Citrate as a Precolonoscopy Bowel Preparation

    Directory of Open Access Journals (Sweden)

    Jonathan Love

    2009-01-01

    Full Text Available BACKGROUND: Sodium picosulfate with magnesium citrate (PSMC has been available as a precolonoscopy bowel preparation in Canada since 2005. A high patient acceptability and preference appears to have contributed to its wide adoption across the country. Despite its frequent use, there are relatively few published studies of this product, especially reports regarding its use in routine clinical practice. Moreover, to date, there have been no Canadian studies of any kind.

  18. A large Italian observational multicentre study on vascular ulcers of the lower limbs (Studio Ulcere Vascolari).

    Science.gov (United States)

    Apollonio, Alessandro; Antignani, Pier L; Di Salvo, Michelangelo; Failla, Giacomo; Guarnera, Giorgio; Mosti, Giovanni; Ricci, Elia

    2016-02-01

    An observational study of 2 years was promoted by the Italian Association for Cutaneous Ulcers (AIUC) in order to monitor the epidemiology of leg ulcers, the trend of healing and the more frequent therapeutic approaches in lower limb ulcers. Fifty-nine sites in 14 different Italian regions involved in the study, with 1333 enrolled patients (1163 patients fully evaluated and followed up for 9 months). A prevalence of females (62%) was observed with a mean age of 70 years and a high rate of hypertension (62%), diabetes (38%) and obesity (29%). Venous ulcer was most frequent (55%), followed by mixed (25%) and diabetic (8·3%) ulcers. Basically, all patients received a local therapy (LT) (compression and advanced local therapies), while 63% of patients have an associated systemic pharmaceutical treatment. Ulcer healing rates progressively increased throughout the study and despite the type of observational study does not allow conclusions on the treatment, it was observed that the patients receiving additional systemic drugs were associated with a more rapid acceleration of healing rates of ulcers compared to LT alone (3 months: 39·7% versus 29·2%; 6 months: 62·0% versus 47·0%; 9 months: 74·7% versus 63·8%). In particular, the Studio Ulcere Vascolari (SUV) study showed that a combination treatment with sulodexide and compression therapy allows for a greater increase in the healing rates in venous ulcers.

  19. Low incidence but poor prognosis of complicated coeliac disease: a retrospective multicentre study.

    Science.gov (United States)

    Biagi, Federico; Gobbi, Paolo; Marchese, Alessandra; Borsotti, Edoardo; Zingone, Fabiana; Ciacci, Carolina; Volta, Umberto; Caio, Giacomo; Carroccio, Antonio; Ambrosiano, Giuseppe; Mansueto, Pasquale; Corazza, Gino R

    2014-03-01

    Coeliac disease is a chronic enteropathy characterized by an increased mortality caused by its complications, mainly refractory coeliac disease, small bowel carcinoma and abdominal lymphoma. Aim of the study was to study the epidemiology of complications in patients with coeliac disease. Retrospective multicenter case-control study based on collection of clinical and laboratory data. The incidence of complicated coeliac disease was studied among coeliac patients directly diagnosed in four Italian centres. Patients referred to these centres after a diagnosis of coeliac disease and/or complicated coeliac disease in other hospitals were therefore excluded. Between 1/1999 and 10/2011, 1840 adult coeliac patients were followed up for 7364.3 person-years. Fourteen developed complications. Since five patients died, at the end of the observation period (10/2011), the prevalence of complicated coeliac disease was 9/1835 (1/204, 0.49%, 95% CI 0.2-0.9%). The annual incidence of complicated coeliac disease in the study period was 14/7364 (0.2%, 95% CI 0.1-0.31%). Although complications tend to occur soon after the diagnosis of coeliac disease, Kaplan-Meier curve analysis showed that they can actually occur at any time after the diagnosis of coeliac disease. Complications of coeliac disease in our cohort were quite rare, though characterised by a very high mortality. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  20. Effects of nebivolol on artery hypertension--multicentre study Bosnia and Herzegovina.

    Science.gov (United States)

    Kusljugić, Zumreta; Divković, Katarina; Baraković, Fahir; Smajić, Elnur; Arslanagić, Amila; Hadziomerović, Mustafa; Fazlibegović, Emir; Midzić, Zlatko; Abdović, Enes; Krneta, Milenko; Celik, Radenko; Basić, Hajro; Avdić, Bajro; Delić, Adnan; Macić-Dzanković, Amra; Keco, Nedzad; Boskailo, Hajra

    2005-02-01

    Hypertension is a major risk factor for cardiovascular diseases; drugs that reduce blood pressure and simultaneously improve or reverse endothelian dysfunction, as nebivolol, may be advantageous in terms of cardiovascular protection. The objective of this study is to show the anti-hypertensive efficacy and safety of nebivolol (5 mg once a day) given to patients with arterial hypertension for 3 months. It should also provide information about drug's influence on laboratory tests--fasting blood glucose and serum cholesterol, triglyceride and creatinine concentrations. Six centers--Tuzla, Sarajevo, Mostar, Bihac, Zenica and Banja Luka participated in this prospective study with follow-up period of 3 months that included 3 visits. The study group consisted of 328 hypertensic patients. Results showed a significant decrease in both systolic and diastolic blood pressure and heart rate at the end of the study. Fasting blood glucose level and serum cholesterol, triglyceride and creatinine changed significantly during the study, with lower levels of all the tests. Nebivolol seems to be free from some of the problems that generally accompany not only the classical beta- blockers but sometimes also newer classes of antihypertensive drugs. With its high anti-hypertensive efficiency and safety, and presence of statically significant difference in laboratory tests and beneficial effects, absence of adverse interaction with glucose and lipid metabolism, patients treated with Nebivolol may show an optimal adherence to therapy.

  1. Association between CASP8 -652 6N del polymorphism (rs3834129) and colorectal cancer risk: results from a multi-centric study.

    Science.gov (United States)

    Pardini, Barbara; Verderio, Paolo; Pizzamiglio, Sara; Nici, Carmela; Maiorana, Maria Valeria; Naccarati, Alessio; Vodickova, Ludmila; Vymetalkova, Veronika; Veneroni, Silvia; Daidone, Maria Grazia; Ravagnani, Fernando; Bianchi, Tiziana; Bujanda, Luis; Carracedo, Angel; Castells, Antoni; Ruiz-Ponte, Clara; Morreau, Hans; Howarth, Kimberley; Jones, Angela; Castellví-Bel, Sergi; Li, Li; Tomlinson, Ian; Van Wezel, Tom; Vodicka, Pavel; Radice, Paolo; Peterlongo, Paolo

    2014-01-01

    The common -652 6N del variant in the CASP8 promoter (rs3834129) has been described as a putative low-penetrance risk factor for different cancer types. In particular, some studies suggested that the deleted allele (del) was inversely associated with CRC risk while other analyses failed to confirm this. Hence, to better understand the role of this variant in the risk of developing CRC, we performed a multi-centric case-control study. In the study, the variant -652 6N del was genotyped in a total of 6,733 CRC cases and 7,576 controls recruited by six different centers located in Spain, Italy, USA, England, Czech Republic and the Netherlands collaborating to the international consortium COGENT (COlorectal cancer GENeTics). Our analysis indicated that rs3834129 was not associated with CRC risk in the full data set. However, the del allele was under-represented in one set of cases with a family history of CRC (per allele model OR = 0.79, 95% CI = 0.69-0.90) suggesting this allele might be a protective factor versus familial CRC. Since this multi-centric case-control study was performed on a very large sample size, it provided robust clarification of the effect of rs3834129 on the risk of developing CRC in Caucasians.

  2. Association between CASP8 -652 6N del polymorphism (rs3834129 and colorectal cancer risk: results from a multi-centric study.

    Directory of Open Access Journals (Sweden)

    Barbara Pardini

    Full Text Available The common -652 6N del variant in the CASP8 promoter (rs3834129 has been described as a putative low-penetrance risk factor for different cancer types. In particular, some studies suggested that the deleted allele (del was inversely associated with CRC risk while other analyses failed to confirm this. Hence, to better understand the role of this variant in the risk of developing CRC, we performed a multi-centric case-control study. In the study, the variant -652 6N del was genotyped in a total of 6,733 CRC cases and 7,576 controls recruited by six different centers located in Spain, Italy, USA, England, Czech Republic and the Netherlands collaborating to the international consortium COGENT (COlorectal cancer GENeTics. Our analysis indicated that rs3834129 was not associated with CRC risk in the full data set. However, the del allele was under-represented in one set of cases with a family history of CRC (per allele model OR = 0.79, 95% CI = 0.69-0.90 suggesting this allele might be a protective factor versus familial CRC. Since this multi-centric case-control study was performed on a very large sample size, it provided robust clarification of the effect of rs3834129 on the risk of developing CRC in Caucasians.

  3. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: A multicentre study of 175 patients

    Directory of Open Access Journals (Sweden)

    Jarius Sven

    2012-01-01

    Full Text Available Abstract Background The diagnostic and pathophysiological relevance of antibodies to aquaporin-4 (AQP4-Ab in patients with neuromyelitis optica spectrum disorders (NMOSD has been intensively studied. However, little is known so far about the clinical impact of AQP4-Ab seropositivity. Objective To analyse systematically the clinical and paraclinical features associated with NMO spectrum disorders in Caucasians in a stratified fashion according to the patients' AQP4-Ab serostatus. Methods Retrospective study of 175 Caucasian patients (AQP4-Ab positive in 78.3%. Results Seropositive patients were found to be predominantly female (p 1 myelitis attacks in the first year were identified as possible predictors of a worse outcome. Conclusion This study provides an overview of the clinical and paraclinical features of NMOSD in Caucasians and demonstrates a number of distinct disease characteristics in seropositive and seronegative patients.

  4. Liraglutide efficacy and action in non-alcoholic steatohepatitis (LEAN): study protocol for a phase II multicentre, double-blinded, randomised, controlled trial.

    Science.gov (United States)

    Armstrong, Matthew J; Barton, Darren; Gaunt, Piers; Hull, Diana; Guo, Kathy; Stocken, Deborah; Gough, Stephen C L; Tomlinson, Jeremy W; Brown, Rachel M; Hübscher, Stefan G; Newsome, Philip N

    2013-11-04

    Non-alcoholic steatohepatitis (NASH) is now the commonest cause of chronic liver disease. Despite this, there are no universally accepted pharmacological therapies for NASH. Liraglutide (Victoza), a human glucagon-like peptide-1 (GLP-1) analogue, has been shown to improve weight loss, glycaemic control and liver enzymes in type 2 diabetes. There is currently a lack of prospective-controlled studies investigating the efficacy of GLP-1 analogues in patients with NASH. Liraglutide efficacy and action in NASH (LEAN) is a phase II, multicentre, double-blinded, placebo-controlled, randomised clinical trial designed to investigate whether a 48-week treatment with 1.8 mg liraglutide will result in improvements in liver histology in patients with NASH. Adult, overweight (body mass index ≥25 kg/m(2)) patients with biopsy-confirmed NASH were assessed for eligibility at five recruitment centres in the UK. Patients who satisfied the eligibility criteria were randomly assigned (1:1) to receive once-daily subcutaneous injections of either 1.8 mg liraglutide or liraglutide-placebo (control). Using A'Hern's single stage phase II methodology (significance level 0.05; power 0.90) and accounting for an estimated 20% withdrawal rate, a minimum of 25 patients were randomised to each treatment group. The primary outcome measure will be centrally assessed using an intention-to-treat analysis of the proportion of evaluable patients achieving an improvement in liver histology between liver biopsies at baseline and after 48 weeks of treatment. Histological improvement will be defined as a combination of the disappearance of active NASH and no worsening in fibrosis. The protocol was approved by the National Research Ethics Service (East Midlands-Northampton committee; 10/H0402/32) and the Medicines and Healthcare products Regulatory Agency. Recruitment into the LEAN started in August 2010 and ended in May 2013, with 52 patients randomised. The treatment follow-up of LEAN participants is

  5. Hormonal treatment of cryptorchidism--hCG or GnRH--a multicentre study

    DEFF Research Database (Denmark)

    Christiansen, P; Müller, J; Buhl, S;

    1992-01-01

    In a modified, double-blind controlled study, 163 prepubertal boys (aged 1.8-13.0 years) with bilateral and 94 (aged 1.5-13.1 years) with unilateral cryptorchidism were allocated to treatment with either human chorionic gonadotrophin (im), gonadotrophin releasing hormone (intranasally) or placebo...

  6. Maverick total disc replacement in a real-world patient population: a prospective, multicentre, observational study.

    Science.gov (United States)

    Assaker, Richard; Ritter-Lang, Karsten; Vardon, Dominique; Litrico, Stéphane; Fuentes, Stéphane; Putzier, Michael; Franke, Jörg; Jarzem, Peter; Guigui, Pierre; Nakach, Gérard; Le Huec, Jean-Charles

    2015-09-01

    Controlled trials have shown that total disc replacement (TDR) can provide pain and disability relief to patients with degenerative disc disease; however, whether these outcomes can also be achieved for patients treated in normal surgical practice has not been well documented. This prospective, international study observed changes in disability and back pain in 134 patients who were implanted with Maverick TDR within the framework of routine clinical practice and followed for 2 years post-surgery. Primary and secondary outcomes were the differences from baseline to 6 months post-surgery in the means of the Oswestry Disability Index and the change in back pain intensity assessed on a 10-cm visual analogue scale, respectively. Mean patient age at surgery was 43 years, but ranged up to 65 years. One hundred twenty-three patients had an implant at one level, 10 patients at two levels, and one patient at three levels. Statistically significant improvements in mean disability (-25.4) and low back pain intensity (-4.0) scores were observed at 6 months postoperatively (P 10 TDRs per centre). During the study, 56 patients (42 %) experienced a complication or adverse event. This is the first international observational study to report outcomes of TDR in real-world clinical settings. We showed statistically significant improvements in disability and pain scores at 6 months following Maverick TDR, which were maintained for 2 years alongside an acceptable rate of perioperative complications. The safety and tolerability shown in this observational study were comparable to those from controlled trials.

  7. Obstacles to Gaining Ethical Approval for a Multi-Centre Study of Family Support

    Science.gov (United States)

    MacPherson, Kristen; Lattin-Rawstrone, Rebekah; Senior, Rob; Barnes, Jacqueline

    2005-01-01

    The NHS has emphasised the need for rigorous evaluations of preventative home-visiting support (Bull and others, 2004) in building a public health evidence base. Interdisciplinary studies involving the NHS in any capacity are subject to ethical review by NHS Research Ethics Committees. However, the current process of ethical review does not…

  8. Patch testing with methyldibromo glutaronitrile, a multicentre study within the EECDRG

    DEFF Research Database (Denmark)

    Gruvberger, B; Andersen, Klaus Ejner; Brandão, F M

    2005-01-01

    Contact allergy to and allergic contact dermatitis from methyldibromo glutaronitrile (MDBGN) have frequently been reported. As there has been no agreement on which MDBGN test preparation to use, a study was initiated to help determine the optimal patch test preparation for MDBGN. 2661 consecutive...

  9. Repeated open application test with methyldibromo glutaronitrile, a multicentre study within the EECDRG

    DEFF Research Database (Denmark)

    Gruvberger, B; Andersen, Klaus Ejner; Brandão, F M

    2005-01-01

    Contact allergy to and allergic contact dermatitis from methyldibromo glutaronitrile (MDBGN) have frequently been reported. This study was initiated to help determine the optimal patch test preparation for MDBGN. In 51 patients with a doubtful or a positive patch test reaction to at least 1 of 4 ...

  10. Short-term outcomes of the prospective multicentre 'Prostate Cancer Research International : Active Surveillance' study

    NARCIS (Netherlands)

    van den Bergh, Roderick C. N.; Vasarainen, Hanna; van der Poel, Henk G.; Vis-Maters, Jenneke J.; Rietbergen, John B.; Pickles, Tom; Cornel, Erik B.; Valdagni, Riccardo; Jaspars, Joris J.; van der Hoeven, John; Staerman, Frederic; Oomens, Eric H. G. M.; Rannikko, Antti; Roemeling, Stijn; Steyerberg, Ewout W.; Roobol, Monique J.; Schroder, Fritz H.; Bangma, Chris H.

    2010-01-01

    OBJECTIVE To evaluate the short-term outcomes of the prospective international Prostate Cancer Research International: Active Surveillance ('PRIAS') study (Dutch Trial Register NTR1718), as active surveillance (AS) for early prostate cancer might provide a partial solution to the current overtreatme

  11. EC multicentre study on small area variations in air quality and health (SAVIAH)

    Energy Technology Data Exchange (ETDEWEB)

    Lebret, E. [National Inst. of Public Health and Environmental Protection (Netherlands); Elliott, P. [London School of Hygiene and Tropical Medicine (United Kingdom); Briggs, D. [Huddersfield Univ. (United Kingdom). Inst. of Environmental and Policy Analysis; Gorynski, P. [National Inst. of Hygiene, Warsaw (Poland); Kriz, B. [National Inst. of Public Health, Prague (Czech Republic)

    1995-12-31

    SAVIAH is an EC-funded methodological study coordinated by Dr. Paul Elliott at the LSHTM (London School of Hygiene and Tropical Medicine). The project aims to apply, test and evaluate new and emerging methodologies in the fields of epidemiology, geography, air pollution modelling and small area health statistics, and to bring the data together in a consistent geographic framework. The study was carried out in the U.K., The Netherlands, Poland and the Czech Republic, using the example of childhood wheeze and outdoor air pollution. Specific aims of the study were, in each centre, (1) to carry out a questionnaire survey among parents of guardians of around 4000 to 5000 children aged between 7 and 11, (2) to carry out a series of air pollution surveys for NO{sub 2} as a proxy for the complex of traffic-related pollutants, and SO{sub 2} (PL), using a dense network of passive samplers, (3) to build up a detailed Geographical Information System (GIS) for each of the study areas; (4) to construct an air pollution `map` based on the NO{sub 2} and SO{sub 2} measurements and a health `map` based on `map smoothing` techniques and (5) to explore methods to examine relationships between health, pollution, socio-economic and other data. (author)

  12. National pholcodine consumption and prevalence of IgE-sensitization: a multicentre study

    DEFF Research Database (Denmark)

    Johansson, S G O; Florvaag, E; Oman, H

    2010-01-01

    The aim of this study was to test, on a multinational level, the pholcodine (PHO) hypothesis, i.e. that the consumption of PHO-containing cough mixtures could cause higher prevalence of IgE antibodies to PHO, morphine (MOR) and suxamethonium (SUX). As a consequence the risk of anaphylaxis...

  13. Evaluation of the therapeutic use of antibiotics in Aegean Region hospitals of Turkey: A multicentric study

    Directory of Open Access Journals (Sweden)

    O Ozgenç

    2011-01-01

    Full Text Available Purpose: The antibiotic restriction policy has been validated nationwide since February 2003 by the Ministry of Health because the excessive consumption of antimicrobials causes a high cost. The aim of this study was to evaluate the therapeutic use of antibiotics in Aegean Region hospitals and to assess the impact of this nationwide antibiotic restriction policy. This new policy is based on justification that the infectious disease (ID physicians should be primarily responsible for the prescription of antimicrobials. Materials and Methods: Eight university and government hospitals were included in the study. The criteria of the Council for Appropriate and Rational Antibiotic Therapy (CARAT were considered. Both patient-based and antibiotic-based analyses were performed. For the analysis of inappropriate use, logistic regression was modeled. Results: Therapeutic use was determined in 540 patients by a total of 29 ID physicians.In the study, 30.2% of the patients were given antimicrobials and empirically started antibiotics accounted for 79% cases of therapeutic antibiotic use, and 60% of those were inappropriate (P = 0.001. The appropriate use of ID level antibiotics (P = 0.000 were very compatible with other antimicrobial groups. Conclusion: The study shows that the Turkish government′s new intervention policy on antimicrobial prescribing has been effective.

  14. A multicentre epidemiological study on sunbed use and cutaneous melanoma in Europe

    NARCIS (Netherlands)

    V. Bataille (Veronique); M. Boniol; E.G.E. de Vries (Elisabeth); G. Severi (Gianluca); Y. Brandberg (Yvonne); P. Sasieni (Peter); J. Cuzick (Jack); A.M.M. Eggermont (Alexander); U. Ringborg; A.-R. Grivegnée (André-Robert); J.W.W. Coebergh (Jan Willem); M.C. Chignol (Marie Christine); J.F. Doré; P.J.M. Autier (Philippe)

    2005-01-01

    textabstractA large European case-control study investigated the association between sunbed use and cutaneous melanoma in an adult population aged between 18 and 49 years. Between 1999 and 2001 sun and sunbed exposure was recorded in 597 newly diagnosed melanoma cases and 622 controls in Belgium, Fr

  15. How patients would like to improve medical consultations: insights from a multicentre European study.

    NARCIS (Netherlands)

    Mazzi, M.A.; Rimondini, M.; Boerma, W.G.W.; Zimmermann, C.; Bensing, J.M.

    2016-01-01

    Objective: In a previous qualitative study (GULiVer-I), a series of lay-people derived recommendations (‘tips’) was listed for doctor and patient on ‘How to make medical consultation more effective from the patient’s perspective’. This work (GULiVer-II) aims to find evidence whether these tips can b

  16. Patch testing with corticosteroid mixes in Europe. A multicentre study of the EECDRG

    DEFF Research Database (Denmark)

    Isaksson, M; Andersen, Klaus Ejner; Brandão, F M;

    2000-01-01

    This study investigated whether a corticosteroid mix containing tixocortol pivalate, budesonide, and hydrocortisone-17-butyrate could detect contact allergy to corticosteroids. 2 corticosteroid mixes, 1 with a high (mix I) and 1 with a low (mix II) concentration and the 3 individual constituents...... allergy to corticosteroid markers was missed....

  17. A multicentre study of air pollution exposure and childhood asthma prevalence: the ESCAPE project

    NARCIS (Netherlands)

    Mölter, Anna; Simpson, Angela; Berdel, Dietrich; Brunekreef, Bert; Custovic, Adnan; Cyrys, Josef; de Jongste, Johan; de Vocht, Frank; Fuertes, Elaine; Gehring, Ulrike; Gruzieva, Olena; Heinrich, Joachim; Hoek, Gerard; Hoffmann, Barbara; Klümper, Claudia; Korek, Michal; Kuhlbusch, Thomas A J; Lindley, Sarah; Postma, Dirkje; Tischer, Christina; Wijga, Alet; Pershagen, Göran; Agius, Raymond

    2015-01-01

    The aim of this study was to determine the effect of six traffic-related air pollution metrics (nitrogen dioxide, nitrogen oxides, particulate matter with an aerodynamic diameter <10 μm (PM10), PM2.5, coarse particulate matter and PM2.5 absorbance) on childhood asthma and wheeze prevalence in five E

  18. Developmental trajectories of social participation in individuals with cerebral palsy : A multicentre longitudinal study

    NARCIS (Netherlands)

    Tan, Siok Swan; Wiegerink, Diana J H G; Vos, Rimke C.; Smits, Dirk Wouter; Voorman, Jeanine M.; Twisk, Jos W R; Ketelaar, Marjolijn; Roebroeck, Marij E.; Dallmeijer, A. J.; Vos, R. C.; Van Eck, M.; Van Schie, P.; Voorman, J. M.; Becher, J. G.; Schuengel, C.; Ketelaar, M.; Smits, D. W.; Lindeman, E.; Jongmans, M.; Roebroeck, M. E.; Tan, S. S.; Wiegerink, D. J H G; Van Meeteren, J.; Reinders-Messelink, H. A.; Gorter, J. W.; Verheijden, J.

    2014-01-01

    Aim: This study aimed to determine the developmental trajectories of social participation, by level of gross motor function and intellectual disability, in a Dutch population of individuals with cerebral palsy (CP) aged 1 to 24 years. Method: As part of the Pediatric Rehabilitation Research in the N

  19. Adherence to MRI protocol consensus guidelines in multiple sclerosis: an Australian multi-centre study.

    Science.gov (United States)

    Curley, Michael; Josey, Lawrence; Lucas, Robyn; Dear, Keith; Taylor, Bruce V; Coulthard, Alan; Chapman, Caron; Coulthard, Alan; Dear, Keith; Dwyer, Terry; Kilpatrick, Trevor; Lucas, Robyn; McMichael, Tony; Pender, Michael P; Ponsonby, Anne-Louise; Taylor, Bruce; Valery, Patricia; van der Mei, Ingrid; Williams, David

    2012-12-01

    Multiple sclerosis (MS) is a debilitating disease that causes significant morbidity within a young demographic. Diagnostic guidelines for MS have evolved, and imaging has played an increasingly important role in diagnosis over the last two decades. For imaging to contribute to diagnosis in a meaningful way, it must be reproducible. Consensus guidelines for MRI in MS exist to define correct sequence type and imaging technique, but it is not clear to what extent they are followed. This study reviewed MRI studies performed on Australian individuals presenting with a first clinical diagnosis of central nervous system demyelination (FCD) for adherence to published guidelines and discussed practical implementation of MS guidelines in light of recent updates. The Ausimmune study was a prospective case control study of Australian participants presenting with FCD from 2003 to 2006. Baseline cranial and spinal cord MRI studies of 226 case participants from four separate Australian regions were reviewed. MRI sequences were classified according to anatomical location, slice plane, tissue weighting and use of gadolinium-containing contrast media. Results were compared with the 2003 Consortium of Multiple Sclerosis Centres MRI protocol for the diagnosis of MS. The composition of core cranial MRI sequences performed varied across the 226 scans. Of the studies, 91% included sagittal fluid attenuated inversion recovery (FLAIR) sequences. Cranial axial T2-weighted, axial FLAIR and axial proton density-weighted sequences were performed in 88%, 60% and 16% (respectively) of scans. Only 25% of the studies included a T1-weighted contrast-enhanced sequence. Concordance with the guidelines in all sequences was very low (2). Only a small number of MRI investigations performed included all of the sequences stipulated by consensus guidelines. This is likely due to poor awareness in the imaging community of the guidelines and the rationale behind certain sequences. Radiologists with a sub

  20. Nonvariceal upper gastrointestinal bleeding in Portugal: a multicentric retrospective study in twelve Portuguese hospitals.

    Science.gov (United States)

    Fonseca, Jorge; Alves, Carlos C; Neto, Rosa; Arroja, Bruno; Vidal, Rosário; Macedo, Guilherme; Nunes, Ana A; Rego, Ana; Carvalho, Joao; Banhudo, António; Curado, António; Lima, Paula N; Baranda, Joao; Ribeiro, Filipe

    2012-01-01

    Nonvariceal upper gastrointestinal bleeding (NVUGIB) is associated with important mortality. More information is needed in order to improve NVUGIB management. The aims of this study were: (a) characterizing Portuguese patients and clinical approaches used in NVUGIB, (b) comparing management used in Portugal with management globally used in European countries, (c) identify factors associated with management options, and (d) identify factors associated with adverse outcome. ENERGiB was an observational, retrospective cohort study, on NVUGIB with endoscopic evaluation, carried across Europe. This study focuses on Portuguese patients of the ENERGiB study. Patients were managed according to routine care. Later, data were collected from files. Multivariate/univariate analyses were conducted on predictive factors of poor outcome and clinical decisions. Patients (n=404) were mostly men (66.8%), mean age 68, with co-morbidities (72%), frequently on NSAIDs/aspirin. Most were assisted by general medical (57.8%) or surgical team (20.6%), only 19.4% by gastroenterology/GI-bleeding team. PPI was largely used. Gastric/duodenal ulcers, erosive gastritis and esophagitis were the main bleeding causes. 10% had bleeding persistence/recurrence. Death occurred in 24 patients, 20 from a non-bleeding related cause. Poor outcomes were related with age >65, co-morbidities, fresh blood haematemesis, shock/syncope, bleeding through previous nasogastric tube, massive fluid replacement or transfusions besides erythrocytes. This study contributed to characterization of Portuguese patients and NVUGIB episodes in real clinical setting and identified factors associated with a poor outcome. It also identified differences, especially in the organization of GI bleeding teams, which might help us to improve the management of these patients. Copyright © 2011 Elsevier España, S.L. and AEEH y AEG. All rights reserved.

  1. A multi-centre study of interactional style in nurse specialist- and physician-led Rheumatology clinics in the UK.

    Science.gov (United States)

    Vinall-Collier, Karen; Madill, Anna; Firth, Jill

    2016-07-01

    Nurse-led care is well established in Rheumatology in the UK and provides follow-up care to people with inflammatory arthritis including treatment, monitoring, patient education and psychosocial support. The aim of this study is to compare and contrast interactional style with patients in physician-led and nurse-led Rheumatology clinics. A multi-centre mixed methods approach was adopted. Nine UK Rheumatology out-patient clinics were observed and audio-recorded May 2009-April 2010. Eighteen practitioners agreed to participate in clinic audio-recordings, researcher observations, and note-taking. Of 9 nurse specialists, 8 were female and 5 of 9 physicians were female. Eight practitioners in each group took part in audio-recorded post-clinic interviews. All patients on the clinic list for those practitioners were invited to participate and 107 were consented and observed. In the nurse specialist cohort 46% were female; 71% had a diagnosis of Rheumatoid Arthritis (RA). The physician cohort comprised 31% female; 40% with RA and 16% unconfirmed diagnosis. Nineteen (18%) of the patients observed were approached for an audio-recorded telephone interview and 15 participated (4 male, 11 female). Forty-four nurse specialist and 63 physician consultations with patients were recorded. Roter's Interactional Analysis System (RIAS) was used to code this data. Thirty-one semi-structured interviews were conducted (16 practitioner, 15 patients) within 24h of observed consultations and were analyzed using thematic analysis. RIAS results illuminated differences between practitioners that can be classified as 'socio-emotional' versus 'task-focussed'. Specifically, nurse specialists and their patients engaged significantly more in the socio-emotional activity of 'building a relationship'. Across practitioners, the greatest proportion of 'patient initiations' were in 'giving medical information' and reflected what patients wanted the practitioner to know rather than giving insight into

  2. Results of Ponseti Brasil Program: Multicentric Study in 1621 Feet: Preliminary Results.

    Science.gov (United States)

    Nogueira, Monica P; Queiroz, Ana C D B F; Melanda, Alessandro G; Tedesco, Ana P; Brandão, Antonio L G; Beling, Claudio; Violante, Francisco H; Brandão, Gilberto F; Ferreira, Laura F A; Brambila, Leandro S; Leite, Leopoldina M; Zabeu, Jose L; Kim, Jung H; Fernandes, Kalyana E; Arima, Marcia A S; Aguilar, Maria D P Q; Farias Filho, Orlando C D; Oliveira Filho, Oscar B D A; Pinho, Solange D S; Moulin, Paulo; Volpi, Reinaldo; Fox, Mark; Greenwald, Miles F; Lyle, Brandon; Morcuende, Jose A

    The Ponseti method has been shown to be the most effective treatment for congenital clubfoot. The current challenge is to establish sustainable national clubfoot treatment programs that utilize the Ponseti method and integrate it within a nation's governmental health system. The Brazilian Ponseti Program (Programa Ponseti Brasil) has increased awareness of the utility of the Ponseti method and has trained >500 Brazilian orthopaedic surgeons in it. A group of 18 of those surgeons had been able to reproduce the Ponseti clubfoot treatment, and compiled their initial results through structured spreadsheet. The study compiled 1040 patients for a total of 1621 feet. The average follow-up time was 2.3 years with an average correction time of approximately 3 months. Patients required an average of 6.40 casts to achieve correction. This study demonstrates that good initial correction rates are reproducible after training; from 1040 patients only 1.4% required a posteromedial release. Level IV.

  3. Complications and functional outcome after fixation of distal tibia fractures with locking plate - A multicentre study

    DEFF Research Database (Denmark)

    Viberg, Bjarke; Kleven, Silje; Hamborg-Petersen, Ellen

    2016-01-01

    and X-ray images for 6 hospitals (1 level 1, 5 level 2) in the Region of Southern Denmark. Between January 2007 and April 2011 70 consecutive patients with 71 distal tibia fractures were treated with low-profile locking plate were included. The proportion of post-operative complications, classified......INTRODUCTION: The aim of this study was to evaluate the proportion of complications and the functional outcome following ORIF with low-profile locking plates in patients with distal tibia fractures. METHOD: Retrospective data was retrieved using county databases, operation books, health record...... score was 73. Thirty-three percent of working patients had not returned to work as a result of the fracture. CONCLUSIONS: Our study suggest that treatment of distal tibia fractures with low-profile locking plates might have a higher proportion of complications and worse functional outcome than...

  4. Odontostomatologic management of patients receiving oral anticoagulant therapy: a retrospective multicentric study.

    Science.gov (United States)

    Inchingolo, Francesco; Tatullo, Marco; Abenavoli, Fabio M; Marrelli, Massimo; Inchingolo, Alessio D; Scacco, Salvatore; Papa, Francesco; Inchingolo, Angelo M; Dipalma, Gianna

    2011-07-19

    Today, we frequently find patients taking oral anticoagulant therapy (OAT), a prophylaxis against the occurrence of thromboembolic events. An oral surgeon needs to know how to better manage such patients, in order to avoid hemorrhagic and thromboembolic complications. A group of 193 patients (119 men aged between 46 and 82 and 74 women aged between 54 and 76) undergoing OAT for more than 5 years were managed with a standardized management protocol and a 2-months follow-up. The aim of the present study was to apply a protocol, which could provide a safe intra- and postoperative management of patients on OAT. Among the 193 patients, only 2 had postoperative complications. We think that the protocol used in the present study can be used for complete safety in the treatment of this type of patients.

  5. Odontostomatologic management of patients receiving oral anticoagulant therapy: a retrospective multicentric study

    Directory of Open Access Journals (Sweden)

    Scacco Salvatore

    2011-07-01

    Full Text Available Abstract Introduction Today, we frequently find patients taking oral anticoagulant therapy (OAT, a prophylaxis against the occurrence of thromboembolic events. An oral surgeon needs to know how to better manage such patients, in order to avoid hemorrhagic and thromboembolic complications. Materials and methods A group of 193 patients (119 men aged between 46 and 82 and 74 women aged between 54 and 76 undergoing OAT for more than 5 years were managed with a standardized management protocol and a 2-months follow-up. The aim of the present study was to apply a protocol, which could provide a safe intra- and postoperative management of patients on OAT. Results Among the 193 patients, only 2 had postoperative complications. Conclusions We think that the protocol used in the present study can be used for complete safety in the treatment of this type of patients.

  6. ABO and Rh (D group distribution and gene frequency; the first multicentric study in India

    Directory of Open Access Journals (Sweden)

    Amit Agrawal

    2014-01-01

    Full Text Available Background and Objectives: The study was undertaken with the objective to provide data on the ABO and Rh(D blood group distribution and gene frequency across India. Materials and Methods: A total of 10,000 healthy blood donors donating in blood banks situated in five different geographical regions of the country (North, South, East and Center were included in the study. ABO and Rh (D grouping was performed on all these samples. Data on the frequency of ABO and Rh(D blood groups was reported in simple numbers and percentages. Results: The study showed that O was the most common blood group (37.12% in the country closely followed by B at 32.26%, followed by A at 22.88% while AB was the least prevalent group at 7.74%. 94.61% of the donor population was Rh positive and the rest were Rh negative. Regional variations were observed in the distribution. Using the maximum likelihood method, the frequencies of the I A , I B and I O alleles were calculated and tested according to the Hardy Weinberg law of Equilibrium. The calculated gene frequencies are 0.1653 for I A (p, 0.2254 for I B (q and 0.6093 for I O (r. In Indian Population, O (r records the highest value followed by B (q and A (p; O > B > A. Conclusion: The study provides information about the relative distribution of various alleles in the Indian population both on a pan-India basis as well as region-wise. This vital information may be helpful in planning for future health challenges, particularly planning with regards to blood transfusion services.

  7. ABO and Rh (D) group distribution and gene frequency; the first multicentric study in India

    Science.gov (United States)

    Agrawal, Amit; Tiwari, Aseem Kumar; Mehta, Nidhi; Bhattacharya, Prasun; Wankhede, Ravi; Tulsiani, Sunita; Kamath, Susheela

    2014-01-01

    Background and Objectives: The study was undertaken with the objective to provide data on the ABO and Rh(D) blood group distribution and gene frequency across India. Materials and Methods: A total of 10,000 healthy blood donors donating in blood banks situated in five different geographical regions of the country (North, South, East and Center) were included in the study. ABO and Rh (D) grouping was performed on all these samples. Data on the frequency of ABO and Rh(D) blood groups was reported in simple numbers and percentages. Results: The study showed that O was the most common blood group (37.12%) in the country closely followed by B at 32.26%, followed by A at 22.88% while AB was the least prevalent group at 7.74%. 94.61% of the donor population was Rh positive and the rest were Rh negative. Regional variations were observed in the distribution. Using the maximum likelihood method, the frequencies of the IA, IB and IO alleles were calculated and tested according to the Hardy Weinberg law of Equilibrium. The calculated gene frequencies are 0.1653 for IA (p), 0.2254 for IB (q) and 0.6093 for IO (r). In Indian Population, O (r) records the highest value followed by B (q) and A (p); O > B > A. Conclusion: The study provides information about the relative distribution of various alleles in the Indian population both on a pan-India basis as well as region-wise. This vital information may be helpful in planning for future health challenges, particularly planning with regards to blood transfusion services. PMID:25161353

  8. Efficacy and safety of pallidal stimulation in primary dystonia: results of the Spanish multicentric study

    OpenAIRE

    Valldeoriola, Francesc; Regidor, Ignacio; Mínguez-Castellanos, Adolfo; Lezcano, Elena; García-Ruiz, Pedro; Rojo, Ana; Salvador, Antonio; Castro, Alfonso; Grandas, Francisco; Martí, Maria José; Martínez-Martín, Pablo; Kulisevsky, Jaime; Relova, Luis; Rumià, Jordi; Cámara, Ana

    2009-01-01

    Abstract We report the results of a prospective, multicenter study with open-label, blinded, as well as self-assessed evaluations to investigate the efficacy and safety of bilateral GPi DBS in patients with primary dystonia. Twenty-four patients from ten different hospitals were included and followed for one year. Clinical assessments were done through blinded scoring of video recordings, open-label evaluations, and self-assessment scales. One year after surgery, baseline motor sco...

  9. Occupation and risk of lymphoma: a multicentre prospective cohort study (EPIC).

    Science.gov (United States)

    Neasham, David; Sifi, Ahlem; Nielsen, Kaspar Rene; Overvad, Kim; Raaschou-Nielsen, Ole; Tjønneland, Anne; Barricarte, Aurelio; González, Carlos A; Navarro, Carmen; Rodriguez Suarez, Laudina; Travis, Ruth C; Key, Tim; Linseisen, Jakob; Kaaks, Rudolf; Crosignani, Paolo; Berrino, Franco; Rosso, Stefano; Mattiello, Amalia; Vermeulen, R C H; Bueno-de-Mesquita, H Bas; Berglund, Göran; Manjer, Jonas; Zackrisson, Sophia; Hallmans, Goran; Malmer, Beatrice; Bingham, Sheila; Khaw, Kay Tee; Bergmann, Manuela M; Boeing, Heiner; Trichopoulou, Antonia; Masala, Giovanna; Tumino, Rosario; Lund, Eiliv; Slimani, Nadia; Ferrari, Pietro; Boffetta, Paolo; Vineis, Paolo; Riboli, Elio

    2011-01-01

    Evidence suggests that certain occupations and related exposures may increase the risk of malignant lymphoma. Farming, printing and paper industry, wood processing, meat handling and processing, welding, shoe and leather manufacturing and teaching profession are among the categories that have been implicated in previous studies. The relationship between occupation and malignant lymphoma has been investigated in a large European prospective study. We investigated occupational risks for lymphomas in the European Prospective Investigation into Cancer and Nutrition (EPIC). The mean follow-up time for 348,555 subjects was 9 years (SD: 2 years). The analysis was based on 866 and 48 newly diagnosed cases of non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma (HL). These were identified in the EPIC subcohorts with occupational data. Data on 52 occupations were collected through standardised questionnaires. Cox proportional hazard models were used to explore the association between occupation and risk of malignant lymphoma. The following occupations were positively associated with malignant NHL after adjustment for study centre, age, sex, socioeconomic status (SES), smoking and alcohol: butchers (HR=1.53, 95% CI 1.05 to 2.48, including multiple myeloma/plasmacytoma; HR=1.30, 95% CI 1.00 to 2.66, excluding multiple myeloma/plasmacytoma) and car repair workers (HR=1.50, 95% CI 1.01 to 2.00, including multiple myeloma/plasmacytoma; HR=1.51, 95% CI 1.01 to 2.31, excluding multiple myeloma/plasmacytoma). HL was associated with gasoline station occupation (HR=4.59, 95% CI 1.08 to 19.6). The findings in this current study of a higher risk of NHL among car repair workers and butchers and a higher risk of HL among gasoline station workers suggest a possible role from occupationally related exposures, such as solvents and zoonotic viruses, as risk factors for malignant lymphoma.

  10. Community and healthcare providers' perspectives on male circumcision: a multi-centric qualitative study in India.

    Directory of Open Access Journals (Sweden)

    Seema Sahay

    Full Text Available Although male circumcision (MC is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs about adult MC as an HIV prevention option in India.This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai cities of India. Of these, 62 respondents were the members of circumcising (CC/non-circumcising communities (NCC; including medically and traditionally circumcised men, parents of circumcised children, spouses of circumcised men, and religious clerics. Additionally, 58 registered healthcare providers (RHCPs such as general and pediatric surgeons, pediatricians, skin and venereal disease specialists, general practitioners, and operation theatre nurses were interviewed. Fourteen traditional circumcisers were also interviewed. The data were coded and analyzed in QSR NUD*IST ver. 6.0. The study has not explored the participants' views about neonatal versus adult circumcision.Members of CC/NCC, traditional circumcisers and RCHPs expressed sharp religious sensitivities around the issue of MC. Six themes emerged: Male circumcision as the religious rite; Multiple meanings of MC: MC for 'religious identity/privilege/sacrifice' or 'hygiene'; MC inflicts pain and cost; Medical indications outweigh faith; Hesitation exists in accepting 'foreign' evidence supporting MC; and communication is the key for acceptance of MCs. Medical indications could make members of NCC accept MC following appropriate counseling. Majority of the RHCPs demanded local in-country evidence.HCPs must educate high-risk groups regarding the preventive and therapeutic role of MC. Communities need to discuss and create new social norms about male circumcision for better societal acceptance especially among the NCC. Feasibility

  11. A controlled multi-centre study of herbal versus synthetic secretolytic drugs for acute bronchitis.

    Science.gov (United States)

    Ernst, E; März, R; Sieder, C

    1997-12-01

    Herbal expectorants and secretolytic drugs hold a sizeable share of the European market. Therefore it is essential to test their clinical effectiveness and safety. The aim of the present study was to compare the herbal medication Bronchipret(®) with various other pharmacotherapeutical options for acute bronchitis. The study was designed as a matched-pair comparison of 7783 patients. Clinical outcomes of bronchitis and adverse reactions were documented. The data were evaluated by comparing the treatment success of the test medication and 3 control groups using ordinal regression. The results suggest that clinical effectiveness of Bronchipret(®) was not less than with synthetic drugs. There was a tendency for better results with Bronchipret(®), particularly in the treatment of adults. Similar results were obtained with respect to adverse reactions. Particularly in the adult sub-group, these were markedly less with herbals as compared to synthetic drugs. These findings imply that a risk/benefit evaluation would favour Bronchipret(®) over synthetic drugs for acute bronchitis. Their interpretation is limited through the fact that this study could not be randomised nor blinded. The results therefore require confirmation through randomised, double-blind trials.

  12. Multi-centred mixed-methods PEPFAR HIV care & support public health evaluation: study protocol

    Directory of Open Access Journals (Sweden)

    Fayers Peter

    2010-09-01

    Full Text Available Abstract Background A public health response is essential to meet the multidimensional needs of patients and families affected by HIV disease in sub-Saharan Africa. In order to appraise curret provision of HIV care and support in East Africa, and to provide evidence-based direction to future care programming, and Public Health Evaluation was commissioned by the PEPFAR programme of the US Government. Methods/Design This paper described the 2-Phase international mixed methods study protocol utilising longitudinal outcome measurement, surveys, patient and family qualitative interviews and focus groups, staff qualitative interviews, health economics and document analysis. Aim 1 To describe the nature and scope of HIV care and support in two African countries, including the types of facilities available, clients seen, and availability of specific components of care [Study Phase 1]. Aim 2 To determine patient health outcomes over time and principle cost drivers [Study Phase 2]. The study objectives are as follows. 1 To undertake a cross-sectional survey of service configuration and activity by sampling 10% of the facilities being funded by PEPFAR to provide HIV care and support in Kenya and Uganda (Phase 1 in order to describe care currently provided, including pharmacy drug reviews to determine availability and supply of essential drugs in HIV management. 2 To conduct patient focus group discussions at each of these (Phase 1 to determine care received. 3 To undertake a longitudinal prospective study of 1200 patients who are newly diagnosed with HIV or patients with HIV who present with a new problem attending PEPFAR care and support services. Data collection includes self-reported quality of life, core palliative outcomes and components of care received (Phase 2. 4 To conduct qualitative interviews with staff, patients and carers in order to explore and understand service issues and care provision in more depth (Phase 2. 5 To undertake document

  13. Phenylketonuria patients' and their parents' knowledge and attitudes to the daily diet - multi-centre study.

    Science.gov (United States)

    Witalis, Ewa; Mikoluc, Bozena; Motkowski, Radoslaw; Sawicka-Powierza, Jolanta; Chrobot, Agnieszka; Didycz, Bozena; Lange, Agata; Mozrzymas, Renata; Milanowski, Andrzej; Nowacka, Maria; Piotrowska-Depta, Mariola; Romanowska, Hanna; Starostecka, Ewa; Wierzba, Jolanta; Skorniewska, Magdalena; Wojcicka-Bartlomiejczyk, Barbara Iwona; Gizewska, Maria; Car, Halina

    2017-01-01

    The aim of the study was to assess both patients' and their parents' knowledge of phenylketonuria (PKU) treatment and compliance with PKU diet. The study included 173 PKU patients aged 10-19 and 110 parents of PKU children who were enrolled in the study on the basis of questionnaire data. The study also included 45 patients aged ≥20. Our study demonstrated that only 45% (n = 74) of PKU patients knew daily Phe intake recommendations, 27% of patients (n = 41) knew the Phe content in a minimum of three out of four researched food products. Patients' knowledge concerning Phe intake (p = 0.0181) and the knowledge of selected food products (p = 0.041819) improved with age. We did not establish such a correlation in the group of PKU children's parents. Approximately 31% of patients and 22% of parents reported helplessness, which increased with the child's age, associated with the necessity to adhere to the diet; 30% of patients reported feeling ashamed of the fact that they could not eat all food products. Regardless of age, children were more likely than parents to report helplessness (p = 0.032005). Among patients, 41.40% declared that they would wish to select products unassisted but their parents did not permit them to do so. The question of whether parents teach children self-reliance in meal preparation was answered affirmatively by 98% of parents and only 81% of children (p = 0.0001). Our data demonstrated that parents' and children's knowledge concerning treatment recommendations and food products does not have a direct impact on attitude to the PKU diet. Limiting children's independence in meal selection, growing helplessness in the face of dietary adherence and shame resulting from the necessity to follow a different diet observed in PKU families are responsible for shaping and perpetuating a consistently negative attitude to the diet. The care of PKU paediatric patients requires consistent, long-term family and individual therapy which may

  14. Vasopressor Use for Severe Hypotension—A Multicentre Prospective Observational Study

    Science.gov (United States)

    Cook, Deborah J.; Meade, Maureen O.; Seely, Andrew; Day, Andrew G.; Charbonney, Emmanuel; Serri, Karim; Skrobik, Yoanna; Hebert, Paul; St-Arnaud, Charles; Quiroz-Martinez, Hector; Mayette, Michaël; Heyland, Daren K.

    2017-01-01

    Background The optimal approach to titrate vasopressor therapy is unclear. Recent sepsis guidelines recommend a mean arterial pressure (MAP) target of 65 mmHg and higher for chronic hypertensive patients. As data emerge from clinical trials comparing blood pressure targets for vasopressor therapy, an accurate description of usual care is required to interpret study results. Our aim was to measure MAP values during vasopressor therapy in Canadian intensive care units (ICUs) and to compare these with stated practices and guidelines. Method In a multicenter prospective cohort study of critically ill adults with severe hypotension, we recorded MAP and vasopressor doses hourly. We investigated variability across patients and centres using multivariable regression models and Analysis of variance (ANOVA), respectively. Results We included data from 56 patients treated in 6 centers. The mean (standard deviation [SD]) age and Acute Physiology and Chronic Health Evaluation (APACHE) II score were 64 (14) and 25 (8). Half (28 of 56) of the patients were at least 65 years old, and half had chronic hypertension. The patient-averaged MAP while receiving vasopressors was 75 mm Hg (6) and the median (1st quartile, 3rd quartile) duration of vasopressor therapy was 43 hours (23, 84). MAP achieved was not associated with history of underlying hypertension (p = 0.46) but did vary by center (p<0.001). Conclusions In this multicenter, prospective observational study, the patient-level average MAP while receiving vasopressors for severe hypotension was 75 mmHg, approximately 10 mmHg above current recommendations and stated practices. Moreover, our results do not support the notion that clinicians tailor vasopressor therapy to individual patient characteristics such as underlying chronic hypertension but MAP achieved while receiving vasopressors varied by site. PMID:28107357

  15. Social disadvantages associated with myasthenia gravis and its treatment: a multicentre cross-sectional study

    Science.gov (United States)

    Nagane, Yuriko; Murai, Hiroyuki; Imai, Tomihiro; Yamamoto, Daisuke; Tsuda, Emiko; Minami, Naoya; Suzuki, Yasushi; Kanai, Tetsuya; Uzawa, Akiyuki; Kawaguchi, Naoki; Masuda, Masayuki; Konno, Shingo; Suzuki, Hidekazu; Aoki, Masashi; Utsugisawa, Kimiaki

    2017-01-01

    Objectives To clarify the social disadvantages associated with myasthenia gravis (MG) and examine associations with its disease and treatment. Design Cross-sectional study. Setting and participants We evaluated 917 consecutive cases of established MG seen at 13 neurological centres in Japan over a short duration. Outcome measures All patients completed a questionnaire on social disadvantages resulting from MG and its treatment and a 15-item MG-specific quality of life scale at study entry. Clinical severity at the worst condition was graded according to the MG Foundation of America classification, and that at the current condition was determined according to the quantitative MG score and MG composite. Maximum dose and duration of dose ≥20 mg/day of oral prednisolone during the disease course were obtained from the patients' medical records. Achievement of the treatment target (minimal manifestation status with prednisolone at ≤5 mg/day) was determined at 1, 2 and 4 years after starting treatment and at study entry. Results We found that 27.2% of the patients had experienced unemployment, 4.1% had been unwillingly transferred and 35.9% had experienced a decrease in income, 47.1% of whom reported that the decrease was ≥50% of their previous total income. In addition, 49.0% of the patients reported feeling reduced social positivity. Factors promoting social disadvantages were severity of illness, dose and duration of prednisolone, long-term treatment, and a depressive state and change in appearance after treatment with oral steroids. Early achievement of the treatment target was a major inhibiting factor. Conclusions Patients with MG often experience unemployment, unwilling job transfers and a decrease in income. In addition, many patients report feeling reduced social positivity. To inhibit the social disadvantages associated with MG and its treatment, greater focus needs to be placed on helping patients with MG resume a normal lifestyle as soon as

  16. Satisfaction of oncologic patients hospitalized in centers with and without service of palliative cares: multicentric study

    Directory of Open Access Journals (Sweden)

    Fernando Campaña Castillo

    2013-09-01

    Full Text Available The aim of this study is to determine the satisfaction regarding care of patients suffering advanced stage cancer admitted in Hospital Sant Jaume de Calella, Sant Rafael de Barcelona and San Lorenzo de Viladecans, subject to the presence or absence of Palliative Care Unit during 2012. An observational, descriptive and transversal study will be conducted.The assessed population are patients admitted to these centers that meet the requirements for inclusion and exclusion.In the Hospital Sant Jaume de Calella, which provides Palliative Care service, patients will be check into the Internal Medicine unit and the Medium-Stay unit. In the other two hospitals, there isn’t any Palliative Care Service and patients will be admitted in the Internal Medicine units of both hospitals. Data will be collected during one year with a sample of 200 patients and non-probably sampling case row.The main variables to consider are the presence or absence of palliative service, satisfaction of care and quality of life of patients to be studied. The secondaries are sex, age, pap score, reason for admission, cancer diagnosis and origin. For the collection of the data we used the questionnaire EORTC IN-PASAT32 modified by the research team and the EORTC QLQ C-15 PAL.The analysis of the quantitative variables will be done through centralization and dispersal parameters. Categorical variables satisfaction of care and quality of life will be analysed using frequencies and joined together by the Chi square. The statistical program SPSS v 16.0 will be used.

  17. Genetic determinants of anti-malarial acquired immunity in a large multi-centre study.

    Science.gov (United States)

    Shelton, Jennifer M G; Corran, Patrick; Risley, Paul; Silva, Nilupa; Hubbart, Christina; Jeffreys, Anna; Rowlands, Kate; Craik, Rachel; Cornelius, Victoria; Hensmann, Meike; Molloy, Sile; Sepulveda, Nuno; Clark, Taane G; Band, Gavin; Clarke, Geraldine M; Spencer, Christopher C A; Kerasidou, Angeliki; Campino, Susana; Auburn, Sarah; Tall, Adama; Ly, Alioune Badara; Mercereau-Puijalon, Odile; Sakuntabhai, Anavaj; Djimdé, Abdoulaye; Maiga, Boubacar; Touré, Ousmane; Doumbo, Ogobara K; Dolo, Amagana; Troye-Blomberg, Marita; Mangano, Valentina D; Verra, Frederica; Modiano, David; Bougouma, Edith; Sirima, Sodiomon B; Ibrahim, Muntaser; Hussain, Ayman; Eid, Nahid; Elzein, Abier; Mohammed, Hiba; Elhassan, Ahmed; Elhassan, Ibrahim; Williams, Thomas N; Ndila, Carolyne; Macharia, Alexander; Marsh, Kevin; Manjurano, Alphaxard; Reyburn, Hugh; Lemnge, Martha; Ishengoma, Deus; Carter, Richard; Karunaweera, Nadira; Fernando, Deepika; Dewasurendra, Rajika; Drakeley, Christopher J; Riley, Eleanor M; Kwiatkowski, Dominic P; Rockett, Kirk A

    2015-08-28

    Many studies report associations between human genetic factors and immunity to malaria but few have been reliably replicated. These studies are usually country-specific, use small sample sizes and are not directly comparable due to differences in methodologies. This study brings together samples and data collected from multiple sites across Africa and Asia to use standardized methods to look for consistent genetic effects on anti-malarial antibody levels. Sera, DNA samples and clinical data were collected from 13,299 individuals from ten sites in Senegal, Mali, Burkina Faso, Sudan, Kenya, Tanzania, and Sri Lanka using standardized methods. DNA was extracted and typed for 202 Single Nucleotide Polymorphisms with known associations to malaria or antibody production, and antibody levels to four clinical grade malarial antigens [AMA1, MSP1, MSP2, and (NANP)4] plus total IgE were measured by ELISA techniques. Regression models were used to investigate the associations of clinical and genetic factors with antibody levels. Malaria infection increased levels of antibodies to malaria antigens and, as expected, stable predictors of anti-malarial antibody levels included age, seasonality, location, and ethnicity. Correlations between antibodies to blood-stage antigens AMA1, MSP1 and MSP2 were higher between themselves than with antibodies to the (NANP)4 epitope of the pre-erythrocytic circumsporozoite protein, while there was little or no correlation with total IgE levels. Individuals with sickle cell trait had significantly lower antibody levels to all blood-stage antigens, and recessive homozygotes for CD36 (rs321198) had significantly lower anti-malarial antibody levels to MSP2. Although the most significant finding with a consistent effect across sites was for sickle cell trait, its effect is likely to be via reducing a microscopically positive parasitaemia rather than directly on antibody levels. However, this study does demonstrate a framework for the feasibility of

  18. A multicentric observational study to evaluate the role of homoeopathic therapy in vitiligo

    Directory of Open Access Journals (Sweden)

    P S Chakraborty

    2015-01-01

    Results: The changes in the mean VSS at intervals of every 6 months was found to be statistically significant. Homoeopathic treatment was found to be useful in relieving vitiligo in varying degrees in 126 patients, out of which 4 (2.94% cases showed marked improvement, 15 (11.03% cases showed moderate improvement, 77 (56.62% cases showed mild improvement, and 30 patients although improved, fell in the category of not significant improvement group (below 25% improvement. Ten homoeopathic medicines were found useful in the study of which Sulphur (n = 27, Arsenicum album (n = 19, Phosphorus (n = 19, and Lycopodium clavatum (n = 10 were the most commonly indicated and useful medicines.

  19. Shortening of treatment duration in patients with chronic hepatitis C genotype 2 and 3 - impact of ribavirin dose - a randomized multicentre trial

    Directory of Open Access Journals (Sweden)

    Bischof Martin

    2011-06-01

    Full Text Available Abstract Background Chronic hepatitis C (CHC Patients, infected with genotype (GT 2 or 3 are treated with Peg-IFN and ribavirin (RBV (800 mg/day for 24 weeks. Treatment duration can be shortened to 12-16 weeks if a higher dose of RBV (1.000/1.200 mg/day was used without considerable loss of responsiveness or increased risk of relapse. Previously we have shown that in patients with CHC, GT 2/3 RBV can be reduced to 400 mg/day if administered for 24 weeks without an increase in relapse rates. Therefore we investigated the efficacy of a reduced RBV dosage of 400 mg/day with shorter treatment duration (16 weeks. Methods Treatment naïve patients with CHC, GT 2/3 were randomized to receive 180 μg peginterferonα2a/week in combination with either 800 (group C or 400 mg/d (group D for 16 weeks. The primary endpoint was SVR. Results 12 months after the first patient was randomized a inferior outcome of group D as compared to group C was noted, therefore the study was terminated. At study termination 89 patients were enrolled (group C: 31, D: 51. The SVR rate was statistically different in the two study groups with 51.6% in group C and 28.4% in group D (p = 0.038. Patients with low viral load had higher SVR rates (C: 67%, D: 33% than those with high viral load (C: 33%, D: 21%. Conclusion Both treatment duration and the dose of RBV play a major role to optimize outcome of patients with GT3. If one intends to shorten the treatment weight based RBV dose should be used, if lower RBV doses are used patients should be treated for at least 24 weeks as. A treatment regimen with a reduced RBV dosage and shortened treatment duration is associated with low SVR rates due to high relapse rates. Trial registration NCT01258101

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

    Directory of Open Access Journals (Sweden)

    Thomas W Kallert

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

  1. Profile of diabetic foot complications and its associated complications--a multicentric study from India.

    Science.gov (United States)

    Viswanathan, V; Thomas, N; Tandon, N; Asirvatham, A; Rajasekar, Seena; Ramachandran, A; Senthilvasan, K; Murugan, V S; Muthulakshmi

    2005-11-01

    The aims of this study were to determine. The prevalence of foot complications such as neuropathy, peripheral vascular disease (PVD), amputations and infections and the associated diabetic complications and practice of foot care among these subjects. A total of 1319 type 2 diabetic patients, were selected from four different centres across India. The centres were Diabetes Research Centre (DRC), Chennai, Government Rajaji Hospital (GRH), Madurai, Christian Medical College (CMC), Vellore and All India Institute of Medical Science (AIIMS), Delhi. Details were collected regarding foot problems and associated complications. The prevalence of neuropathy was 15% (n=193) and PVD was 5% (n=64). Infections were present in 7.6% (n=100) of patients. The infection rate varied from 6-11% in the different centres. Nearly 3% of subjects had undergone a minor or major amputation. This study found that the prevalence of infection was 6-11% and prevalence of amputation was 3% in type 2 diabetic patients. Neuropathy (15%) was found to be an important risk factor for diabetic foot infections. Effective foot care advice should be propagated to reduce the burden imposed by diabetic foot complication particularly in developing countries like India.

  2. Repeated open application test with methyldibromo glutaronitrile, a multicentre study within the EECDRG.

    Science.gov (United States)

    Gruvberger, B; Andersen, K E; Brandão, F M; Bruynzeel, D P; Bruze, M; Frosch, P J; Goossens, A; Lahti, A; Maibach, H I; Menné, T; Orton, D; Seidenari, S

    2005-01-01

    Contact allergy to and allergic contact dermatitis from methyldibromo glutaronitrile (MDBGN) have frequently been reported. This study was initiated to help determine the optimal patch test preparation for MDBGN. In 51 patients with a doubtful or a positive patch test reaction to at least 1 of 4 test preparations with MDBGN in petrolatum at 1.0% w/w, 0.5%, 0.3% and 0.1%, a repeated open application test (ROAT) with moisturizers with and without MDBGN at 0.03% w/w was performed on the upper arms for 2 weeks. 18 of the 51 (35.3%) patients developed a positive ROAT. In all patients, there was a positive ROAT only to the moisturizer with MDBGN (P < 0.001). A statistically significant association was also found between the patch test reactivity (PTRL) and the outcome of the ROAT (P < 0.001). If only considering those with a PTRL above 0.3%, thus with negative or doubtful test reactions to 0.1% and 0.3%, there were still statistically significantly more patients with a positive ROAT to the moisturizer with MDBGN than to the moisturizer without MDBGN. The study demonstrates that patch testing with MDBGN at 0.3% and 0.1% will miss clinically relevant patch test reactions to MDBGN.

  3. National pholcodine consumption and prevalence of IgE-sensitization: a multicentre study.

    Science.gov (United States)

    Johansson, S G O; Florvaag, E; Oman, H; Poulsen, L K; Mertes, P M; Harper, N J N; Garvey, L H; Gerth van Wijk, R; Metso, T; Irgens, A; Dybendal, T; Halsey, J; Seneviratne, S L; Guttormsen, A B

    2010-04-01

    The aim of this study was to test, on a multinational level, the pholcodine (PHO) hypothesis, i.e. that the consumption of PHO-containing cough mixtures could cause higher prevalence of IgE antibodies to PHO, morphine (MOR) and suxamethonium (SUX). As a consequence the risk of anaphylaxis to neuromuscular blocking agents (NMBA) will be increased. National PHO consumptions were derived from the United Nations International Narcotics Control Board (INCB) database. IgE and IgE antibodies to PHO, MOR, SUX and P-aminophenyl-phosphoryl choline (PAPPC) were measured in sera from atopic individuals, defined by a positive Phadiatop test (>0.35 kU(A)/l), collected in nine countries representing high and low PHO-consuming nations. There was a significant positive association between PHO consumption and prevalences of IgE-sensitization to PHO and MOR, but not to SUX and PAPPC, as calculated both by exposure group comparisons and linear regression analysis. The Netherlands and the USA, did not have PHO-containing drugs on the markets, although the former had a considerable PHO consumption. Both countries had high figures of IgE-sensitization. This international prevalence study lends additional support to the PHO hypothesis and, consequently, that continued use of drugs containing this substance should be seriously questioned. The results also indicate that other, yet unknown, substances may lead to IgE-sensitization towards NMBAs.

  4. Review of Van earthquakes form an orthopaedic perspective: a multicentre retrospective study.

    Science.gov (United States)

    Guner, Savas; Guner, Sukriye Ilkay; Isik, Yasemin; Gormeli, Gokay; Kalender, Ali Murat; Turktas, Ugur; Gokalp, Mehmet Ata; Gozen, Abdurrahim; Isik, Mustafa; Ozkan, Sezai; Turkozu, Tulin; Karadas, Sevdegul; Ceylan, Mehmet Fethi; Ediz, Levent; Bulut, Mehmet; Gunes, Yusuf; Gormeli, Ayse; Erturk, Cemil; Eseoglu, Metehan; Dursun, Recep

    2013-01-01

    This is a descriptive analysis, of victims of Turkey's October 23, 2011 and November 21, 2011 Van earthquakes. The goal of this study is investigated the injury profile of the both earthquakes in relation to musculoskeletal trauma. We retrospectively reviewed medical records of 3,965 patients admitted to in seven hospitals. A large share of these injuries were soft tissue injuries, followed by fractures, crush injuries, crush syndromes, nerve injuries, vascular injuries, compartment syndrome and joint dislocations. A total of 73 crush injuries were diagnosed and 31 of them were developed compartment syndrome. The patients with closed undisplaced fractures were treated with casting braces. For closed unstable fractures with good skin and soft-tissue conditions, open reduction and internal fixation was performed. All patients with open fracture had an external fixator applied after adequate debridement. Thirty one of 40 patients with compartment syndrome were treated by fasciotomy. For twelve of them, amputation was necessary. The most common procedure performed was debridement, followed by open reduction and internal fixation and closed reduction-casting, respectively. The results of this study may provide the basis for future development of strategy to optimise attempts at rescue and plan treatment of survivors with musculoskeletal injuries after earthquakes.

  5. A cross-sectional, multicentre study of the therapeutic management of multiple sclerosis relapses in Italy.

    Science.gov (United States)

    Annovazzi, Pietro; Tomassini, Valentina; Bodini, Benedetta; Boffa, Laura; Calabrese, Massimiliano; Cocco, Eleonora; Cordioli, Cinzia; De Luca, Giovanna; Frisullo, Giovanni; Gallo, Antonio; Malucchi, Simona; Paolicelli, Damiano; Pesci, Ilaria; Radaelli, Marta; Ragonese, Paolo; Roccatagliata, Luca; Tortorella, Carla; Vercellino, Marco; Zipoli, Valentina; Gasperini, Claudio; Rodegher, Mariaemma; Solaro, Claudio

    2013-02-01

    Despite the existence of therapeutic guidelines, management of multiple sclerosis relapse remains heterogeneous. Optimisation of relapse outcome demands an improved understanding of the neurologist's therapeutic attitude towards relapse management, which is the aim of this study. Neurologists from 13 multiple sclerosis centres completed a questionnaire every time they assessed multiple sclerosis relapses. The questionnaire requested a guided description of the relapse's clinical characteristics and an indication of the prescribed therapy, supported with up to 3 out of 20 suggested reasons. Over 3 months, 368 questionnaires were collected. Median percentage (%) of 21 relapses resulting in a prescription was 88.9%. Corticosteroids represented the most frequent prescription. A short-course of high-dose intravenous methylprednisolone was the most used corticosteroid (73.7%). Treatment was administrated mainly in day case unit (80.0%) and at home (13.6%). A tapered therapy was prescribed to 28.8% of patients. Neurologists' therapeutic decisions were driven mainly by relapse severity (45.3%) and symptom evolution (24.2%). Our study confirms the therapeutic attitude of multiple sclerosis specialists in treating relapses with high-dose intravenous corticosteroids in a day hospital setting, with a tapering in a proportion of cases. The main reasons for prescription are relapse severity and symptom evolution.

  6. Interobserver agreement in describing video capsule endoscopy findings: a multicentre prospective study.

    Science.gov (United States)

    Pezzoli, Alessandro; Cannizzaro, Renato; Pennazio, Marco; Rondonotti, Emanuele; Zancanella, Laura; Fusetti, Nadia; Simoni, Marzia; Cantoni, Franco; Melina, Raffaele; Alberani, Angela; Caravelli, Giancarlo; Villa, Federica; Chilovi, Fausto; Casetti, Tino; Iaquinto, Gaetano; D'imperio, Nicola; Gullini, Sergio

    2011-02-01

    Few studies have specifically addressed interobserver agreement in describing lesions identified during capsule endoscopy. The aim of our study is to evaluate interobserver agreement in the description of capsule endoscopy findings. Consecutive short segments of capsule endoscopy were prospectively observed by 8 investigators. Seventy-five videos were prepared by an external investigator (gold standard). The description of the findings was reported by the investigators using the same validated and standardized capsule endoscopy structured terminology. The agreement was assessed using Cohen's kappa statistic. As concerns the ability to detect a lesion, the agreement with the gold standard was moderate (kappa 0.48), as well as the agreement relating to the final diagnosis (κ 0.45). The best agreement was observed in identifying the presence of active bleeding (κ 0.72), whereas the poorest agreement concerned the lesion size (κ 0.32). The agreement with the GS was significantly better in endoscopists with higher case/volume of capsule endoscopy per year. Diagnostic concordance was better in the presence of angiectasia than in the presence of polyps or ulcers/erosions. Correct lesion identification and diagnosis seem more likely to occur in presence of angiectasia, and for readers with more experience in capsule endoscopy reading. Published by Elsevier Ltd.

  7. Health promoting lifestyle behaviour in medical students: a multicentre study from Turkey.

    Science.gov (United States)

    Nacar, Melis; Baykan, Zeynep; Cetinkaya, Fevziye; Arslantas, Didem; Ozer, Ali; Coskun, Ozlem; Bati, Hilal; Karaoglu, Nazan; Elmali, Ferhan; Yilmaze, Gulay

    2014-01-01

    The aim of this study was to determine the predictors of health promoting lifestyle behaviour among medical students attending seven of the medical schools in Turkey. This cross- sectional descriptive study was performed during the second semester of the first and last (sixth) years of study from March to May 2011. A questionnaire with two sections was specifically designed. The first section contained questions on demographic characteristics; the second consisted of the Health Promoting Lifestyle Profile II (HPLP) Scale. From a total of 2,309 medical students, 2,118 (response rate 91.7%) completed the questionnaire. Data were analyzed using descriptive statistics, t, Anova, Tukey test and binary logistic regression analysis. The research was approved by the Ethics Committee of Erciyes University. The mean age was 20.7±2.9 years and it was found that 55.1% were men, 62.3% were in the first year. The overall prevalence of smoking was 19.1%, and for drinking alcohol was 19.4%. HPLP point averages of the first year students were 129.2±17.7, and for last year 125.5±19.0. The overall mean score for the HPLP II was 2.5±0.4. They scored highest on the spiritual growth subscale (2.9±0.5), interpersonal relations (2.8±0.5), health responsibility subscale (2.3±0.5), nutrition subscale (2.3±0.5), stress management subscale (2.3±0.4), and the lowest subscale physical activity (2.0±0.5). It is established that student's grade, educational level of parents, economic status of family, marital status, smoking and general health perception of the students resulted in a significant difference in HPLP Scale total score average and the mean score of majority of subscales.There was no statistically significant difference between the total HPLP when evaluated for gender, chronic disease, alcohol drinking status and BMI. Based on these results, particularly in the curriculum of medical students in order to increase positive health behaviours including physical activity, health

  8. Complications and functional outcome after fixation of distal tibia fractures with locking plate - A multicentre study

    DEFF Research Database (Denmark)

    Viberg, Bjarke; Kleven, Silje; Hamborg-Petersen, Ellen;

    2016-01-01

    INTRODUCTION: The aim of this study was to evaluate the proportion of complications and the functional outcome following ORIF with low-profile locking plates in patients with distal tibia fractures. METHOD: Retrospective data was retrieved using county databases, operation books, health record...... as minor and major complications, was retrieved from electronic health records and patient interviews. Long-term functional outcome assessed by EuroQol EQ-5D-5L questionnaire, AOFAS Ankle-Hindfoot scale, and return to pre-injury job function through patient interview and examination. RESULTS: There were 32...... 43A, 5 43B and 34 43C-fractures, 12 open and 10 high-energy fractures. Forty-nine cases (69%) experienced complications during the follow-up time, of which 34 were minor complications and 15 were major complications. Median EQ-5D-5L index value was 0.76, median EQ VAS-score was 80, and median AOFAS...

  9. Spasmodic Torticollis—A Multicentre Study on Behavioural Aspects II: Signs, Symptoms and Course

    Directory of Open Access Journals (Sweden)

    F. Heinen

    1996-01-01

    Full Text Available This paper deals with signs, symptoms and course in spasmodic torticollis (ST. Two hundred and fifty-six patients were included in the study, 59.3% women, 40.7% men. The mean age was 49.1 years. Rotating torticollis out-numbered latero- and antero-retrocollis. A family history of ST occurred in 3.1% of the total sample. First degree relatives were affected in 2.3%. Thirty-four per cent of the patients had additional dystonic symptoms. Most frequently these affected the upper extremities (13%, and less often the legs. Of the patients 19.1% had experienced a period of complete remission. The correlations between the severity of the signs and the neurological symptoms are surprisingly weak.

  10. Multiple myeloma in Nigeria: a multi-centre epidemiological and biomedical study

    Science.gov (United States)

    Nnonyelum, Odunukwe Nkiruka; Anazoeze, Madu Jude; Eunice, Nnodu Obigeli; Emmanuel, Okocha Onyichide; Stella, Akingbola Titilola; Marcus, Asuquo Inyama; Taiwo, Balogun Modupe; Olufela, Kalejaiye Olufunto; Chinawaeze, Aneke John; Orkuma, Joseph Aondowase; Dalhat, Gwarzo Gwarzo; Otobo, Ujah Innocent

    2015-01-01

    Introduction Myelomatosis is a malignant proliferation of plasma cells in the bone marrow, with relatively high prevalence in African populations. Variation in genetic mutations has been observed in individual patients and may be responsible for differences in disease pattern and treatment outcomes. This study described the presentations and treatment outcomes of multiple myeloma in nigerian. Methods The data was obtained retrospectively from the case notes of 135 patients diagnosed with multiple myeloma from eight tertiary health institutions across the six geopolitical zones of Nigeria from 2005 to 2014. Data analysis was carried out using SPSS 17.0. Results The predominant presentations were bone pain in 97 (74%), nephropathy in 47 (35.9%) and pathological fractures in 58 (44.3%). Sixty-seven percent (67%) of the patients were less than 60 years, and 35% had Bence Jones proteinuria. The overall survival beyond 6 months was 91.3%, mean duration of survival rate was 7.4 months. Majority (66.2%) were on Melphalan alone or on melphalan-containing combinations. A higher packed cell volume (PCV) and total serum protein levels at presentation were associated with increased survival, p=0.033 and 0.036, respectively. Conclusion This study portrayed the importance of detail investigation on the causes of bone pain and anaemia in person's aged 40 years and above. There is a high prevalence of nephropathy in this cohort of patients which needs to be further investigated. Majority of the patients, though < 65 years of age were placed on melphalan-containing combinations, which foreclosed chances of future autologous bone marrow transplantation. PMID:26966488

  11. [Hemolysis interferences on frequently required stat analysis: a French multicentric study].

    Science.gov (United States)

    Poupon, Carole; Lefèvre, Guillaume; Ngo-François, Sandrine; Alibeu, Catherine; Barbé, Françoise; Bourbonneux, Valery; Cartier, Régine; Morin, Christine; Szymanowicz, Anton; Vuillaume, Isabelle

    2015-01-01

    Hemolysis should lead to changes in test results. Our study evaluated the impact of hemolysis on 26 blood measurements of stat biochemistry markers (sodium, potassium, chloride, urea, creatinine, glucose, total protein, calcium, magnesium, inorganic phosphorus, uric acid, C-reactive protein, total bilirubin, ASAT, ALAT, LDH, creatine kinase, alkaline phosphatase, γ glutamyl-transferase, lipase, alcohol, iron, β hCG, troponins, natriuretic peptides) determined with 13 different types of instruments in 17 hospital laboratories. Four pools of samples (collected from lithium heparin or EDTA or sodium fluoride tubes, according to the measured parameters) were overloaded with five increasing concentrations of whole blood lysate (final concentration from 0 to 2.000 mg/dL). Replication was performed for each assay, average values were calculated and differences between results with and without lysate were analyzed. A difference exceeding the square root of the sum of both squared analytic and biologic imprecisions for each analyte, was judged to be significant. Except homogeneous and expected impact of hemolysis on certain parameters like potassium, LDH... (due to their intra-erythrocyte concentration) a heterogeneous effect was found for other parameters, according to the analyzer and/or to the methodology. In summary, this study confirms the importance of mastering the measurement of the hemolysis and leads to several recommendations: (i) biologists should have a good knowledge of the impact of hemolysis on the measurements they perform, depending on their chosen analyzers; (ii) if an interference is noticed, it is recommended to add to the result a relevant comment and to check that the comment is properly edited in the laboratory computer software and appears on printed and transmitted results.

  12. Premorbid nutrition and short term outcome of stroke: a multicentre study from India.

    Science.gov (United States)

    Pandian, Jeyaraj Durai; Jyotsna, Rashmi; Singh, Ruma; Sylaja, Padmavati N; Vijaya, Pamidimukkala; Padma, Madakasira Vasantha; Venkateswaralu, Kolichana; Sukumaran, Sajith; Radhakrishnan, Kurupath; Sarma, Prabhakaran S; Mathew, Robert; Singh, Yashpal

    2011-10-01

    Little is known about the impact of premorbid undernutrition on stroke outcome in developing countries. To study the impact of premorbid undernutrition status, measured by the Subjective Global Assessment (SGA) tool, on short term stroke outcome. First ever stroke patients admitted to six major hospitals in North and South India participated in this study from 1 March 2008 to 30 September 2009. The SGA tool was administered within 48 h of stroke onset, and 6 months premorbid nutritional status was rated as well nourished (A rating) and undernourished (B and C ratings) using this tool. Stroke outcome was assessed after 30 days using the modified Rankin scale (mRs), and a mRs score >3 was defined as a poor outcome. Statistical analyses were performed using SPSS Statistics V.17.0. Of 477 patients enrolled, 448 patients were included in the analyses. Mean age was 58.1±13.7 years (range 16-96) and 281 (62.7%) patients were men. At admission, premorbid undernutrition was found in 121 (27.2%) patients. Older age (OR 4.99, CI 1.26 to 19.64, p=0.021), hypertension (OR 1.99, CI 1.04 to 3.79, p=0.037) and patients from Andhra Pradesh State (OR 1.87, CI 1.05 to 3.32, p=0.032) were predictors of undernutrition in multiple logistic regression analysis. Premorbid undernutrition (OR 1.99, CI 1.20 to 3.31, p=0.007) and length of hospital stay (OR 3.41, CI 1.91 to 6.06, pstroke patients were found. Age, hypertension and patients from Andhra Pradesh State were predictors of premorbid undernutrition. Premorbid undernutrition was associated with poor stroke outcome. The results provide opportunities for primary prevention and improving stroke outcome.

  13. Incidence of complications in bronchoscopy. Multicentre prospective study of 20,986 bronchoscopies.

    Science.gov (United States)

    Facciolongo, N; Patelli, M; Gasparini, S; Lazzari Agli, L; Salio, M; Simonassi, C; Del Prato, B; Zanoni, P

    2009-03-01

    To evaluate the frequency of complications in bronchoscopy from data compiled between 1/2/2002 to 1/2/2003. Nineteen Italian centres of thoracic endoscopy participated in the study, for a total of 20,986 bronchoscopies (FBS), including 10,658 explorative bronchoscopies (EB) (50.79%), 5,520 bronchial biopsies (BB) (26.30%), 1,660 transbronchial biopsies (TBB) (7.91%), 1,127 broncho-alveolar lavages (BAL) (5.37%), 930 transbronchial needle-aspirates (TBNA) (4.43%), 1.091 therapeutic bronchoscopies (TB), comprising ND-YAG Laser, argon-plasma, electrocautery knife, stent insertion (5.20%). 82.4% of the procedures involved the use of a flexible bronchoscope, 16.3% were carried out using a rigid bronchoscope and 1.3% using the mixed technique. The total number of complications recorded was 227 (1.08% of the cases examined), including 20 (0.09%) during local anesthesia and pre-medication, 195 (0.92%) during the endoscopic procedures and 12 (0.05%) in the two hours following FBS. The total number of deaths was 4 (0.02%), due to cardiac arrest, pulmonary edema, delayed respiratory failure and shock in pre-medication, respectively. 68.28% of the complications were treated medically, 25.99% by means of endoscopy and 5.72% with surgery. The healing percentage was 98.2%. This study has shown that bronchoscopy is a safe method with low incidence of mortality and complications. The preparation, experience and continuous training of the operators of the medical and nursing team seem to play a fundamental role in reducing the incidence of complications at least in certain procedures such as BB and TBB.

  14. [Chondromatose of the temporomandibular joint: Multicentric study and clarification from 14 cases].

    Science.gov (United States)

    Massereau, E; Cheynet, F; Bénateau, H; Veyssière, A; Bencheman, Y; Gallucci, A; Hammoutène, S; Chossegros, C

    2016-09-01

    The aim of our study was to analyse a series of patients suffering from temporomandibular joint (TMJ) chondromatosis treated in 2 departments of stomatology and maxillofacial surgery (University hospitals of the Conception in Marseille and of Caen) and to make a general review of this disease. We conducted a retrospective study including all the patients treated for a TMJ chondromatosis in one of these 2 departments. Following parameters were analyzed: sex, ages at discovery and at surgery, symptoms, side, imaging, histology, recurrence and any other events considered as relevant. Fourteen patients could be included: 85.7 % were women. Average age at diagnosis was 40.14 (σ = 13.82; IC95: 32.90-47.38) (41 for women [σ = 14.74; IC95: 33.28-48.72] and 35 years for men [σ = 5.66, IC95: 27.16-42.84]). Average age at surgery was 40.86 (σ = 14.18; IC95: 33.43-48.28). There was no predominance of side; 57.14 % of the patients had a joint syndrome, 57.14 % a tumor syndrome, 28.57 % had pain and 14.29 % had headaches. Panoramic X-ray was informative in 3 cases only. CT scan showed intra-articular calcifications in half of the cases only but arthrosic modifications in all the cases. Magnetic resonance imaging (MRI) constantly showed intra-articular cartilage fragments. When histology was performed, it found the synovial to be normal in one case and multiple nodules with clear cartilaginous differentiation in another case. One patient suffered from a second contralateral localization 10 years later. Chondromatosis has a slow evolution and is asymptomatic for a long time. MRI allows to evoke the diagnosis and to locate precisely the osteochondromas. Diagnosis is confirmed by histology that highlights a synovial metaplasia and more or less calcified chondromas. The main differential diagnosis to be eliminated because of prognostic reasons is the synovial chondrosarcoma. Treatment consists in surgical removing of the chondromas. Evolution is usually

  15. Spectrum of hemoglobinopathies among the primitive tribes: a multicentric study in India.

    Science.gov (United States)

    Mohanty, Dipika; Mukherjee, Malay B; Colah, Roshan B; Wadia, Mahrukh; Ghosh, Kanjaksha; Chottray, Guru Prasad; Jain, Dipty; Italia, Yazdi; Ashokan, Kumar S; Kaul, Rajni; Shukla, Deepak K; Muthuswamy, Vasantha

    2015-03-01

    We evaluated the spectrum of hemoglobinopathies among the primitive tribal groups from 4 states in India. A total of 15,200 individuals from 14 primitive tribal groups were studied by automated high-performance liquid chromatography. The hemoglobin S (HbS) allele frequency varied from 0.011 to 0.120 and the β-thalassemia allele frequency from 0.005 to 0.024. It is interesting to note that a very high HbS allele frequency was observed among the Dravidian (0.060-0.120) and Indo-European (0.060-0.076) as compared with Austro-Asiatic (0.011-0.022) speaking tribal groups. Although statistical analysis of the data did not show any ethnic differences within the states, regional differences were observed between the states for both HbS and β-thalassemia traits. HbS was found to be the most common hemoglobinopathy followed by β-thalassemia. A health plan for identifying sickle-cell homozygotes in the neonatal period with proper medical intervention is desirable.

  16. [Results of a multicentric study for the prevention of atopic allergy. 48 months of follow up].

    Science.gov (United States)

    Bruno, G; Giampietro, P G; Businco, L

    1996-10-01

    With the cooperation of 12 Maternity Hospitals we have started a prospective study to evaluate the effect of dietary and environmental measures in the development of atopic disease in "at risk" newborns. The preventive measures included: exclusive breast feeding for the first 6 months of life, soy milk supplement when breast milk is not sufficient, elimination of house dust, no smoking in the house, etc. All infants were seen at the age of 1, 3, 6, 9, 12 months and twice-a-year afterwards. 1213 babies have been enrolled. At the last follow-up of 48 months 531 children are 4 year old. The cumulative prevalence of atopic disease was 20%: 11 (2%) children developed atopic dermatitis, 69 (13%) asthma, 21 (4%) rinithis, 5 (1%) urticaria. The low prevalence of atopic disease and the trivial course of the allergic manifestations in the children who followed the preventive measures (78/444 = 18%) and the higher (28/87 = 32%) in these who did not (p < 0.01) stressed the importance of such manipulations for the prevention of atopy in "at risk" babies.

  17. The average body surface area of adult cancer patients in the UK: a multicentre retrospective study.

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    Joseph J Sacco

    Full Text Available The majority of chemotherapy drugs are dosed based on body surface area (BSA. No standard BSA values for patients being treated in the United Kingdom are available on which to base dose and cost calculations. We therefore retrospectively assessed the BSA of patients receiving chemotherapy treatment at three oncology centres in the UK between 1(st January 2005 and 31(st December 2005.A total of 3613 patients receiving chemotherapy for head and neck, ovarian, lung, upper GI/pancreas, breast or colorectal cancers were included. The overall mean BSA was 1.79 m(2 (95% CI 1.78-1.80 with a mean BSA for men of 1.91 m(2 (1.90-1.92 and 1.71 m(2 (1.70-1.72 for women. Results were consistent across the three centres. No significant differences were noted between treatment in the adjuvant or palliative setting in patients with breast or colorectal cancer. However, statistically significant, albeit small, differences were detected between some tumour groups.In view of the consistency of results between three geographically distinct UK cancer centres, we believe the results of this study may be generalised and used in future costings and budgeting for new chemotherapy agents in the UK.

  18. Patch testing with methyldibromo glutaronitrile, a multicentre study within the EECDRG.

    Science.gov (United States)

    Gruvberger, B; Andersen, K E; Brandão, F M; Bruynzeel, D P; Bruze, M; Frosch, P J; Goossens, A; Lahti, A; Lindberg, M; Menné, T; Orton, D; Seidenari, S

    2005-01-01

    Contact allergy to and allergic contact dermatitis from methyldibromo glutaronitrile (MDBGN) have frequently been reported. As there has been no agreement on which MDBGN test preparation to use, a study was initiated to help determine the optimal patch test preparation for MDBGN. 2661 consecutively patch tested patients at 11 test clinics representing 9 European countries participated. Petrolatum preparations with MDBGN at 1.0%, 0.5%, 0.3% and 0.1% were inserted in the standard series. Contact allergy rates were noted in the range 4.4-1.1% following decreasing test concentrations. Reactions not fulfilling all criteria to be classified as allergic reactions could represent either weak allergic or irritant reactions, and such reactions were noted in the range 8.2-0.5% with decreasing concentrations. A significant number of these reactions represented weak allergic reactions, as allergic reactions were obtained to higher patch test concentrations in the same individual. Morphologically irritant reactions were noted only for the highest test concentrations. In summary, the contact allergy rates and frequencies of doubtful and irritant reactions vary with the patch test concentration. The final decision on patch test concentration for MDBGN should not only rely on these factors but also include information on patch test concentrations required to diagnose individual cases with allergic contact dermatitis from MDBGN as well as results of repeated open application tests.

  19. The proximity between hallucination and delusion dimensions: An observational, analytic, cross-sectional, multicentre study

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    Diogo Telles-correia

    2016-11-01

    Full Text Available 5.In the current psychiatric classifications, hallucinations (mainly auditory hallucinations are one of the fundamental criteria for establishing a schizophrenia diagnosis or any of the related psychotic disorder’s diagnoses.6.Throughout the history of Psychiatry the conceptual proximity between delusions and hallucinations in the psychiatric patient was maintained until the end of the XIX century,with several supporters during the XX century. Their frontier was not yet definitely defined in terms of Descriptive Psychopathology, and much less so in terms of biochemical and anatomical models.7.In this article we aimed to analyse the dimensions of both hallucinations and delusions in a sample of patients with schizophrenia and schizoaffective disorder. We also intend to find the determinants of the main dimensions of hallucinations.8.One hundred patients with schizophrenia or schizoaffective disorder from both the outpatient and inpatient units of the Psychiatry Department of Hospital of Santa Maria and the Centro Hospitalar Psiquiátrico de Lisboa were assessed by means of the Psychotic Symptom Rating Scales (PSYRATS. 9.In this study we found an empirical based model, where the main dimensions of hallucinations are determined by the central dimensions of delusions. 10.Keywords: Psyrats, Hallucinations, Psychopathology, Psychosis, delusions

  20. [Multi-centric clinical study of trial of labor after cesarean section].

    Science.gov (United States)

    Yu, L; Su, C H; Wang, X Y; Gong, J J; Chen, P; Du, H M; Quan, Q H; Li, L L; Chen, D J

    2016-08-25

    To study the feasibility and safety of trial of labor after cesarean section (TOLAC). Retrospective analysis of five medical center of Guangdong province from January 2011 to December 2015 hospitalized delivery information, compare the same scar TOLAC (research group) with the scar pregnancy (control group) pregnancy outcomes, to study the feasibility and safety of TOLAC. (1) During 2011-2015, total delivery 95 600 cases in five medical center, 13 824 cases of thme with uterine scar pregnancy, including 12 027 cases elective repeat cesarean section and 1 797 cases (13.00%, 1 797/13 824) with scar uterus vaginal trial of labor. Among 1 308 cases of vaginal delivery, the success for trial of labor rate was 72.79% (1 308/1 797). From 2011 to 2015, there were increased rate of pregnancy after cesarean section, which were respectively 10.71%, 13.28%, 14.45%, 15.54% and 16.98%. The will of vaginal birth were rising and the rate were respectively 11.85%, 12.25%, 13.49%, 13.82% and 12.93%. (2) There were 489 (27.21%, 489/1 797) cases of scar uterus maternal emergency cesarean section in the trial of labor, reason for "social factors" require for cesarean delivery have 68 cases, the percentage was 13.91% (68/489), compared with control group (7.18%, 206/2 869), the difference was statistically significant difference (χ(2)=27.356, P=0.000). Doctors diagnosed as "aura uterine rupture" in the labor was 11.86% (58/489), compared with that in control group (1.43%, 41/2 869), the differences were statistically significant difference (χ(2)=1 578.223, P=0.000). (3) The incidence of uterine rupture of the research group (0.74%, 9/1 211) was significantly higher than that of control group (0.01%,2/31 200; χ(2)> 2 000, P=0.000). The incidence of postpartum hemorrhage in research group was 6.94% (84/1 211), compared with that in the control group (3.05%, 951/31 200), there was statistically significant difference (χ(2)=16.328, P=0.000). While, there were no statistical

  1. Bullying and Victimization in Overweight and Obese Outpatient Children and Adolescents: An Italian Multicentric Study.

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    Dario Bacchini

    Full Text Available Being overweight or obese is one of the most common reasons that children and adolescents are teased at school. We carried out a study in order to investigate: i the relation between weight status and school bullying and ii the relation between weight status categories and types of victimization and bullying in an outpatient sample of Italian children and adolescents with different degrees of overweight from minimal overweight up to severe obesity.Nine-hundred-forty-seven outpatient children and adolescents (age range 6.0-14.0 years were recruited in 14 hospitals distributed over the country of Italy. The participants were classified as normal-weight (N = 129, overweight (N = 126, moderately obese (N = 568, and severely obese (N = 124. The nature and extent of verbal, physical and relational bullying and victimization were assessed with an adapted version of the revised Olweus bully-victim questionnaire. Each participant was coded as bully, victim, bully-victim, or not involved.Normal-weight and overweight participants were less involved in bullying than obese participants; severely obese males were more involved in the double role of bully and victim. Severely obese children and adolescents suffered not only from verbal victimization but also from physical victimization and exclusion from group activities. Weight status categories were not directly related to bullying behaviour; however severely obese males perpetrated more bullying behaviour compared to severely obese females.Obesity and bullying among children and adolescents are of ongoing concern worldwide and may be closely related. Common strategies of intervention are needed to cope with these two social health challenges.

  2. Additional erythrocytic and reticulocytic parameters helpful for diagnosis of hereditary spherocytosis: results of a multicentre study.

    Science.gov (United States)

    Mullier, François; Lainey, Elodie; Fenneteau, Odile; Da Costa, Lydie; Schillinger, Françoise; Bailly, Nicolas; Cornet, Yvan; Chatelain, Christian; Dogne, Jean-Michel; Chatelain, Bernard

    2011-07-01

    Hereditary spherocytosis (HS) is characterised by weakened vertical linkages between the membrane skeleton and the red blood cell's lipid bilayer, leading to the release of microparticles. All the reference tests suffer from specific limitations. The aim of this study was to develop easy to use diagnostic tool for screening of hereditary spherocytosis based on routinely acquired haematological parameters like percentage of microcytes, percentage of hypochromic cells, reticulocyte counts, and percentage of immature reticulocytes. The levels of haemoglobin, mean cell volume, mean corpuscular haemoglobin concentration, reticulocytes (Ret), immature reticulocytes fraction (IRF), hypochromic erythrocytes (Hypo-He) and microcytic erythrocytes (MicroR) were determined on EDTA samples on Sysmex instruments from a cohort of 45 confirmed SH. The HS group was then compared with haemolytical disorders, microcytic anaemia, healthy individuals and routine samples (n = 1,488). HS is characterised by a high Ret count without an equally elevated IRF. All 45 HS have Ret >80,000/μl and Ret(10(9)/L)/IRF (%) greater than 7.7 (rule 1). Trait and mild HS had a Ret/IRF ratio greater than 19. Moderate and severe HS had increased MicroR and MicroR/Hypo-He (rule 2). Combination of both rules gave predictive positive value and negative predictive value of respectively 75% and 100% (n=1,488), which is much greater than single parameters or existing rules. This simple and fast diagnostic method could be used as an excellent screening tool for HS. It is also valid for mild HS, neonates and ABO incompatibilities and overcomes the lack of sensitivity of electrophoresis in ankyrin deficiencies.

  3. Cardiac complications and diabetes in thalassaemia major: a large historical multicentre study.

    Science.gov (United States)

    Pepe, Alessia; Meloni, Antonella; Rossi, Giuseppe; Caruso, Vincenzo; Cuccia, Liana; Spasiano, Anna; Gerardi, Calogera; Zuccarelli, Angelo; D'Ascola, Domenico G; Grimaldi, Salvatore; Santodirocco, Michele; Campisi, Saveria; Lai, Maria E; Piraino, Basilia; Chiodi, Elisabetta; Ascioti, Claudio; Gulino, Letizia; Positano, Vincenzo; Lombardi, Massimo; Gamberini, Maria R

    2013-11-01

    The relationship between diabetes mellitus (DM) and cardiac complications has never been systematically studied in thalassaemia major (TM). We evaluated a large retrospective historical cohort of TM to determine whether DM is associated with a higher risk of heart complications. We compared 86 TM patients affected by DM with 709 TM patients without DM consecutively included in the Myocardial Iron Overload in Thalassaemia database where clinical/instrumental data are recorded from birth to the first cardiovascular magnetic resonance (CMR) exam. All of the cardiac events considered were developed after the DM diagnosis. In DM patients versus non-DM patients we found a significantly higher frequency of cardiac complications (46.5% vs. 16.9%, P < 0.0001), heart failure (HF) (30.2% vs. 11.7%, P < 0.0001), hyperkinetic arrhythmias (18.6% vs. 5.5%, P < 0.0001) and myocardial fibrosis assessed by late gadolinium enhancement (29.9% vs. 18.4%, P = 0.008). TM patients with DM had a significantly higher risk of cardiac complications [odds ratio (OR) 2.84, P < 0.0001], HF (OR 2.32, P = 0.003), hyperkinetic arrhythmias (OR 2.21, P = 0.023) and myocardial fibrosis (OR 1.91, P = 0.021), also adjusting for the absence of myocardial iron overload assessed by T2* CMR and for the covariates (age and/or endocrine co-morbidity). In conclusion, DM significantly increases the risk for cardiac complications, HF, hyperkinetic arrhythmias and myocardial fibrosis in TM patients.

  4. Assessing the therapeutic usefulness of Ricinus communis: A multicentric observational clinical verification study

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    P S Chakraborty

    2014-01-01

    Full Text Available Introduction: Clinical verification is an ongoing research programme of the Central Council for Research in Homoeopathy, under which many symptoms of Indian and rarely used drugs in Homoeopathy have been clinically verified. Objectives: To clinically verify the symptomatology of Ricinus communis as observed during its proving conducted by Council and also to ascertain the clinical symptoms relieved in the process of verification. Materials and Methods: Two hundred and twenty-five patients from all age-groups and both sexes were enrolled from the outpatient departments (OPDs of the institutes and units of the Council following the exclusion and inclusion criteria as per protocol and obtaining written consent. The presenting signs and symptoms were recorded in a predefined case recording proforma and if Ricinus communis was found very closely similar to the symptoms of the patient, the patients were enrolled in the study. The medicine was prescribed in different potencies as per the need of the case and in accordance with homoeopathic principles. The progress was noted in a follow-up sheet to determine the effects of the medicine, in relieving the symptoms of the patient. Result: Forty eight out of fifty three symptoms obtained from proving of Ricinus communis could be clinically verified. The characteristic indications were left-sided affinity, aggravation from sun, amelioration in open air, dryness of mucous membrane of gastrointestinal tract, dissatisfaction leading to irritability and anger. The usefulness of the medicine was mostly marked in relieving headache, coryza, aphthae, gastritis, diarrhoea, constipation and acne. All the verified symptoms indicated the scope of its therapeutic action. Conclusion: Ricinus communis can be considered as an important medicine for the management of acne, aphthae, backache, colic, constipation, coryza, cough, diarrhoea, dyspepsia, fever, gastritis, headache and irritability.

  5. MIRU-VNTR Genotyping of Mycobacterium tuberculosis Strains Using QIAxcel Technology: A Multicentre Evaluation Study.

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    Vladyslav Nikolayevskyy

    Full Text Available Molecular genotyping of M.tuberculosis is an important laboratory tool in the context of emerging drug resistant TB. The standard 24-loci MIRU-VNTR typing includes PCR amplification followed by the detection and sizing of PCR fragments using capillary electrophoresis on automated sequencers or using agarose gels. The QIAxcel Advanced system might offer a cost-effective medium-throughput alternative.Performance characteristics of the QIAxcel Advanced platform for the standard 24 VNTR loci panel was evaluated at two centres on a total of 140 DNA specimens using automated capillary electrophoresis as a reference method. Additionally 4 hypervariable MIRU-VNTR loci were evaluated on 53 crude DNA extracts. The sizing accuracy, interlaboratory reproducibility and overall instrument's performance were assessed during the study.An overall concordance with the reference method was high reaching 98.5% and 97.6% for diluted genomic and crude DNA extracts respectively. 91.4% of all discrepancies were observed in fragments longer than 700bp. The concordance for hypervariable loci was lower except for locus 4120 (96.2%. The interlaboratory reproducibility agreement rates were 98.9% and 91.3% for standard and hypervariable loci, respectively. Overall performance of the QIAxcel platform for M.tuberculosis genotyping using a panel of standard loci is comparable to that of established methods for PCR fragments up to 700bp. Inaccuracies in sizing of longer fragments could be resolved through using in-house size markers or introduction of offset values. To conclude, the QiaXcel system could be considered an effective alternative to existing methods in smaller reference and regional laboratories offering good performance and shorter turnaround times.

  6. Risk of facial splashes in four major surgical specialties in a multicentre study.

    Science.gov (United States)

    Endo, S; Kanemitsu, K; Ishii, H; Narita, M; Nemoto, T; Yaginuma, G; Mikami, Y; Unno, M; Hen, R; Tabayashi, K; Matsushima, T; Kunishima, H; Kaku, M

    2007-09-01

    This study analyses the results of face-shield blood spatter contamination at six medical facilities to determine exposure risk when facial protection is not used. Blood spatter exposure was evaluated on the basis of overall incidence, location of spatter on face shields, surgical specialty, risk for operating room staff, length of surgery and volume of blood loss. Six hundred face shields were evaluated for blood spatter contamination by visual inspection as well as by staining with leucomalachite green. The face shield was divided into three regions: Orbital (O-region), Paraorbital (P-region) and Mask (M-region). Visual examination detected blood spatter contamination in 50.5% (303/600) of the face shields, whereas leucomalachite green staining detected blood contamination in 66.0% (396/600). Blood contamination was 36.6% (220/600) in the O-region, 37.8% (227/600) in the P-region and 57.0% (342/600) in the M-region. Among operating room staff, the incidence of blood spatter was greatest among lead surgeons at 83.5% (167/200), followed by the first assistant at 68.5% (137/200) and the scrub nurse at 46.0% (92/200). By specialty, cardiovascular surgery was at highest risk with an incidence of 75.3% (113/150) followed by neurosurgery at 69.3% (104/150), gastrointestinal at 60.0% (90/150) and orthopaedic surgery at 60.0% (90/150).

  7. Bronchopulmonary Carcinoids causing Cushing Syndrome: Results from a Multicentric Study Suggesting a More Aggressive Behavior.

    Science.gov (United States)

    Lococo, Filippo; Margaritora, Stefano; Cardillo, Giuseppe; Filosso, Perluigi; Novellis, Pierluigi; Rapicetta, Cristian; Carleo, Francesco; Bora, Giulia; Cesario, Alfredo; Stefani, Alessandro; Rossi, Giulio; Paci, Massimiliano

    2016-03-01

    Cushing syndrome (CS) caused by bronchopulmonary carcinoids (BCs) is a very rare entity. The aim of this study was to revisit the features of a multicenter clinical series to identify significant prognostic factors. From January 2002 to December 2013, the clinical and pathological data of 23 patients (treated in five different institutions) were retrospectively reviewed. Survival analysis was performed to explore the relative weight of potential prognostic factors. Median age and male/female ratio were 48 years and 14/9, respectively. Most (> 80%) of the patients presented with CS-related symptoms at diagnosis. Tumor location was peripheral in 13 patients (57%) and central in 10 (43%). All patients but two (treated with chemotherapy) underwent surgical resection with curative intent. Definitive cyto/histology was indicative of typical carcinoid (TC) in 16 cases (70%) and atypical carcinoid (AC) in 7 cases (30%). A complete remission of CS was obtained in 16 cases (70%). Lymph nodal involvement was detected in 11 cases (48%), with N2 disease occurring in 7 (∼ 30% of all cases). Four patients (22%) experienced a relapse of the disease after radical surgery. Overall 5-year survival (long-term survival, LTS) was 60%, better in TCs when compared with AC (LTS: 66 v s. 48%, p = 0.28). Log-rank analysis identified ECOG performance status, cTNM and cN staging, pTNM and pN staging, persistence of CS and relapses (local p = 0.006; distant p = 0.001) as significant prognostic factors in this cohort of patients. BCs causing CS are characterized by a high rate of lymph-nodal involvement, a suboptimal prognosis (5-year survival = 60%, 66% in TCs) and a remarkable risk of relapse even after radical resection. Advanced stage, lymph-nodal involvement and the persisting of the CS after treatment correlate with a poor prognosis. Georg Thieme Verlag KG Stuttgart · New York.

  8. Faculty perspective on competency-based research education: A multi-centre study from Saudi Arabia

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    Hamza Naji

    2017-01-01

    Full Text Available Introduction: Research is becoming indispensable in today's medical education and clinical practice. Engaging medical students in research activities and producing clinically competent and research-oriented medical students are essential demands of today's modern medicine. Incorporating research-based competencies and designing research-oriented medical curricula are challenging and need more attention, especially in developing countries. The aim of this study was to identify research competencies for medical students and the best instructional modality for their integration in the medical curricula. Methodology: A list of research competencies needed to be acquired by medical students during their undergraduate level have been proposed and classified under the following categories: general research skills, biostatistics, basic biomedical research and clinical research and epidemiology. The competencies were further reviewed by academicians of different fields. Afterwards, a questionnaire was prepared targeting researchers who have mentored undergraduate medical students in Riyadh, Saudi Arabia. Research mentors were asked to rate the importance of the competencies listed using a 5-point Likert scale and to determine how they should be delivered into the medical curricula. Results: Results showed that Likert scale mean score ranged from 3.44 to 4.71, illustrating mentors' agreement to the importance of the competencies listed. Around 52% and 58% of mentors choose 'compulsory component' in case of 'general research skills' and 'biostatistics', respectively. On the other hand, 75% and 66% of mentors choose 'non-compulsory component' in case of 'basic research' and 'clinical research and epidemiology', respectively. Conclusion: Standardisation of competencies might help to better integrate research competencies in medical curricula.

  9. 'You're judged all the time!' Students' views on professionalism: a multicentre study.

    Science.gov (United States)

    Finn, Gabrielle; Garner, Jayne; Sawdon, Marina

    2010-08-01

    This study describes how medical students perceive professionalism and the context in which it is relevant to them. An understanding of how Phase 1 students perceive professionalism will help us to teach this subject more effectively. Phase 1 medical students are those in the first 2 years of a 5-year medical degree. Seventy-two undergraduate students from two UK medical schools participated in 13 semi-structured focus groups. Focus groups, carried out until thematic saturation occurred, were recorded and transcribed verbatim. Data were analysed and coded using NVivo 8, using a grounded theory approach with constant comparison. From the analysis, seven themes regarding professionalism emerged: the context of professionalism; role-modelling; scrutiny of behaviour; professional identity; 'switching on' professionalism; leniency (for students with regard to professional standards), and sacrifice (of freedom as an individual). Students regarded professionalism as being relevant in three contexts: the clinical, the university and the virtual. Students called for leniency during their undergraduate course, opposing the guidance from Good Medical Practice. Unique findings were the impact of clothing and the online social networking site Facebook on professional behaviour and identity. Changing clothing was described as a mechanism by which students 'switch on' their professional identity. Students perceived society to be struggling with the distinction between doctors as individuals and professionals. This extended to the students' online identities on Facebook. Institutions' expectations of high standards of professionalism were associated with a feeling of sacrifice by students caused by the perception of constantly 'being watched'; this perception was coupled with resentment of this intrusion. Students described the significant impact that role-modelling had on their professional attitudes. This research offers valuable insight into how Phase 1 medical students

  10. Suboptimal management of central nervous system infections in children: a multi-centre retrospective study

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    Kelly Christine

    2012-09-01

    Full Text Available Abstract Objective We aimed to audit the regional management of central nervous system (CNS infection in children. Methods The study was undertaken in five district general hospitals and one tertiary paediatric hospital in the Mersey region of the UK. Children admitted to hospital with a suspected CNS infection over a three month period were identified. Children were aged between 4 weeks and 16 years old. Details were recorded from the case notes and electronic records. We measured the appropriateness of management pathways as outlined by national and local guidelines. Results Sixty-five children were identified with a median age of 6 months (range 1 month to 15 years. Ten had a CNS infection: 4 aseptic meningitis, 3 purulent meningitis, 3 encephalitis [2 with herpes simplex virus (HSV type 1]. A lumbar puncture (LP was attempted in 50 (77% cases but only 43 had cerebrospinal fluid (CSF available for analysis. Of these 24 (57% had a complete standard set of tests performed. Fifty eight (89% received a third generation cephalosporin. Seventeen (26% also received aciclovir with no obvious indication in 9 (53%. Only 11 (65% of those receiving aciclovir had CSF herpes virus PCR. Seventeen had cranial imaging and it was the first management step in 14. Treatment lengths of both antibiotics and aciclovir were highly variable: one child with HSV encephalitis was only treated with aciclovir for 7 days. Conclusions The clinical management of children with suspected CNS infections across the Mersey region is heterogeneous and often sub-optimal, particularly for the investigation and treatment of viral encephalitis. National guidelines for the management of viral encephalitis are needed.

  11. Bullying and Victimization in Overweight and Obese Outpatient Children and Adolescents: An Italian Multicentric Study

    Science.gov (United States)

    Garrasi, Alessandra; Corciulo, Nicola; Driul, Daniela; Tanas, Rita; Fiumani, Perla Maria; Di Pietro, Elena; Pesce, Sabino; Crinò, Antonino; Maltoni, Giulio; Iughetti, Lorenzo; Sartorio, Alessandro; Deiana, Manuela; Lombardi, Francesca

    2015-01-01

    Objective Being overweight or obese is one of the most common reasons that children and adolescents are teased at school. We carried out a study in order to investigate: i) the relation between weight status and school bullying and ii) the relation between weight status categories and types of victimization and bullying in an outpatient sample of Italian children and adolescents with different degrees of overweight from minimal overweight up to severe obesity. Participants/Methods Nine-hundred-forty-seven outpatient children and adolescents (age range 6.0–14.0 years) were recruited in 14 hospitals distributed over the country of Italy. The participants were classified as normal-weight (N = 129), overweight (N = 126), moderately obese (N = 568), and severely obese (N = 124). The nature and extent of verbal, physical and relational bullying and victimization were assessed with an adapted version of the revised Olweus bully-victim questionnaire. Each participant was coded as bully, victim, bully-victim, or not involved. Results Normal-weight and overweight participants were less involved in bullying than obese participants; severely obese males were more involved in the double role of bully and victim. Severely obese children and adolescents suffered not only from verbal victimization but also from physical victimization and exclusion from group activities. Weight status categories were not directly related to bullying behaviour; however severely obese males perpetrated more bullying behaviour compared to severely obese females. Conclusions Obesity and bullying among children and adolescents are of ongoing concern worldwide and may be closely related. Common strategies of intervention are needed to cope with these two social health challenges. PMID:26606393

  12. Image reporting and characterization system for ultrasound features of thyroid nodules: Multicentric Korean retrospective study

    Energy Technology Data Exchange (ETDEWEB)

    Kwak, Jin Young [Dept. of Radiology, Severance Hospital, Research Institute of Radiological Science, Yonsei University College of Medicine, Seoul (Korea, Republic of); Jung, In Kyung [Dept. of Biostatistics, Yonsei University College of Medicine, Seoul (Korea, Republic of); Beak, Jung Hwan [Dept. of Radiology and Research Institute of Radiology, Asan Medical Center, University of Ulsan College of Medicine, Seou (Korea, Republic of); and others

    2013-01-15

    The objective of this retrospective study was to develop and validate a simple diagnostic prediction model by using ultrasound (US) features of thyroid nodules obtained from multicenter retrospective data. Patient data were collected from 20 different institutions and the data included 2000 thyroid nodules from 1796 patients. For developing a diagnostic prediction model to estimate the malignant risk of thyroid nodules using suspicious malignant US features, we developed a training model in a subset of 1402 nodules from 1260 patients. Several suspicious malignant US features were evaluated to create the prediction model using a scoring tool. The scores for such US features were estimated by calculating odds ratios, and the risk score of malignancy for each thyroid nodule was defined as the sum of these individual scores. Later, we verified the usefulness of developed scoring system by applying into the remaining 598 nodules from 536 patients. Among 2000 tumors, 1268 were benign and 732 were malignant. In our multiple regression analysis models, the following US features were statistically significant for malignant nodules when using the training data set: hypoechogenicity, marked hypoechogenicity, non-parallel orientation, microlobulated or spiculated margin, ill-defined margins, and microcalcifications. The malignancy rate was 7.3% in thyroid nodules that did not have suspicious-malignant features on US. Area under the receiver operating characteristic (ROC) curve was 0.867, which shows that the US risk score help predict thyroid malignancy well. In the test data set, the malignancy rates were 6.2% in thyroid nodules without malignant features on US. Area under the ROC curve of the test set was 0.872 when using the prediction model. The predictor model using suspicious malignant US features may be helpful in risk stratification of thyroid nodules.

  13. Febrile morbidity in severe and critical ovarian hyperstimulation syndrome: a multicentre study.

    Science.gov (United States)

    Abramov, Y; Elchalal, U; Schenker, J G

    1998-11-01

    The objective of this study was to define the incidence of febrile morbidity and its causes in severe and critical ovarian hyperstimulation syndrome (OHSS). For this purpose, we reviewed the medical records of all OHSS patients hospitalized in 16 out of 19 tertiary medical centres in Israel between January 1987 and December 1996. Febrile morbidity was defined as at least one episode of temperature rise above 38 degrees C lasting > or =24 h. A total of 2902 patients (3305 hospitalizations) with OHSS was identified, of whom 196 had severe, and 13 critical, OHSS. Among the 209 patients investigated the incidence of febrile morbidity was 82.3%, of which 20.5% was attributed to urinary tract infection, 3.8% to pneumonia, 3.3% to upper respiratory tract infection, 2.0% to intravenous line phlebitis, 1.0% to cellulitis at an abdominal puncture site, 1.0% to postoperative wound infections and 0.5 % to gluteal abscess at the site of progesterone injection. Non-typical organisms were frequently isolated, such as Pseudomonas, Proteus, Klebsiella and Enterobacter species. No infectious aetiology was found in 105 patients (50.2%). Hypoglobulinaemia was recorded in most patients, while ascitic and pleural fluids aspirated from these patients contained high globulin concentrations. We conclude that infection-related febrile morbidity in severe and critical OHSS is high, and may be attributed to some degree of immunodeficiency associated with loss of plasma globulins to the third space. However, non-infection-related febrile morbidity is even higher and may be attributed to endogenous pyrogenic mechanisms.

  14. A multicentre study of Shigella diarrhoea in six Asian countries: disease burden, clinical manifestations, and microbiology.

    Directory of Open Access Journals (Sweden)

    Lorenz von Seidlein

    2006-09-01

    Full Text Available The burden of shigellosis is greatest in resource-poor countries. Although this diarrheal disease has been thought to cause considerable morbidity and mortality in excess of 1,000,000 deaths globally per year, little recent data are available to guide intervention strategies in Asia. We conducted a prospective, population-based study in six Asian countries to gain a better understanding of the current disease burden, clinical manifestations, and microbiology of shigellosis in Asia.Over 600,000 persons of all ages residing in Bangladesh, China, Pakistan, Indonesia, Vietnam, and Thailand were included in the surveillance. Shigella was isolated from 2,927 (5% of 56,958 diarrhoea episodes detected between 2000 and 2004. The overall incidence of treated shigellosis was 2.1 episodes per 1,000 residents per year in all ages and 13.2/1,000/y in children under 60 months old. Shigellosis incidence increased after age 40 years. S. flexneri was the most frequently isolated Shigella species (1,976/2,927 [68%] in all sites except in Thailand, where S. sonnei was most frequently detected (124/146 [85%]. S. flexneri serotypes were highly heterogeneous in their distribution from site to site, and even from year to year. PCR detected ipaH, the gene encoding invasion plasmid antigen H in 33% of a sample of culture-negative stool specimens. The majority of S. flexneri isolates in each site were resistant to amoxicillin and cotrimoxazole. Ciprofloxacin-resistant S. flexneri isolates were identified in China (18/305 [6%], Pakistan (8/242 [3%], and Vietnam (5/282 [2%].Shigella appears to be more ubiquitous in Asian impoverished populations than previously thought, and antibiotic-resistant strains of different species and serotypes have emerged. Focusing on prevention of shigellosis could exert an immediate benefit first by substantially reducing the overall diarrhoea burden in the region and second by preventing the spread of panresistant Shigella strains. The

  15. Comparative assessment of image quality for coronary CT angiography with iobitridol and two contrast agents with higher iodine concentrations: iopromide and iomeprol. A multicentre randomized double-blind trial

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    Achenbach, Stephan [Friedrich-Alexander-Universitaet Erlangen-Nuernberg, Department of Cardiology, Erlangen (Germany); Paul, Jean-Francois [Centre Chirurgical Marie Lannelongue, Department of Radiology, Le Plessis Robinson (France); Laurent, Francois [University of Bordeaux, Centre de Recherche Cardio-Thoracique de Bordeaux, U1045, Bordeaux (France); CHU de Bordeaux, Service d' Imagerie Thoracique et Cardiovasculaire, Pessac (France); Becker, Hans-Christoph [University Hospital Grosshadern, Department of Clinical Radiology, Munich (Germany); Rengo, Marco [Sapienza - University of Rome, ICOT Hospital, Department of Radiological Sciences, Oncology and Pathology, Latina (Italy); Caudron, Jerome [University Hospital of Rouen, Department of Radiology, Rouen (France); Leschka, Sebastian [Saint Gallen Hospital, Department of Radiology, Saint Gallen (Switzerland); Vignaux, Olivier [Cochin Hospital, Department of Radiology, Paris (France); Knobloch, Gesine [La Charite, Department of Radiology, Berlin (Germany); Benea, Giorgio [Ospedale del Delta, Ferrara (Italy); Schlosser, Thomas [Elisabeth-Krankenhaus Hospital, Essen (Germany); Andreu, Jordi [Hospital Vall d' Hebron, Barcelona (Spain); Cabeza, Beatriz [Hospital Clinico San Carlos, Madrid (Spain); Jacquier, Alexis [La Timone Adult Hospital, Department of Radiology, Marseille (France); Souto, Miguel [Complejo Hospitalario Universitario, Santiago de Compostela (Spain); Revel, Didier [Louis Pradel Hospital, Department of Radiology, Lyon (France); Qanadli, Salah Dine [University of Lausanne, Department of Radiology, Lausanne (Switzerland); Cademartiri, Filippo [Giovanni XXIII Hospital, Department of Radiology, Monastier di Treviso (Italy); Collaboration: X-ACT Study Group

    2017-02-15

    To demonstrate non-inferiority of iobitridol 350 for coronary CT angiography (CTA) compared to higher iodine content contrast media regarding rate of patients evaluable for the presence of coronary artery stenoses. In this multicentre trial, 452 patients were randomized to receive iobitridol 350, iopromide 370 or iomeprol 400 and underwent coronary CTA using CT systems with 64-detector rows or more. Two core lab readers assessed 18 coronary segments per patient regarding image quality (score 0 = non diagnostic to 4 = excellent quality), vascular attenuation, signal and contrast to noise ratio (SNR, CNR). Patients were considered evaluable if no segment had a score of 0. Per-patient, the rate of fully evaluable CT scans was 92.1, 95.4 and 94.6 % for iobitridol, iopromide and iomeprol, respectively. Non-inferiority of iobitridol over the best comparator was demonstrated with a 95 % CI of the difference of [-8.8 to 2.1], with a pre-specified non-inferiority margin of -10 %. Although average attenuation increased with higher iodine concentrations, average SNR and CNR did not differ between groups. With current CT technology, iobitridol 350 mg iodine/ml is not inferior to contrast media with higher iodine concentrations in terms of image quality for coronary stenosis assessment. (orig.)

  16. Actual performance of mechanical ventilators in ICU: a multicentric quality control study

    Directory of Open Access Journals (Sweden)

    Govoni L

    2012-12-01

    Full Text Available Leonardo Govoni,1 Raffaele L Dellaca,1 Oscar Peñuelas,2,3 Giacomo Bellani,4,5 Antonio Artigas,3,6 Miquel Ferrer,3,7 Daniel Navajas,3,8,9 Antonio Pedotti,1 Ramon Farré3,81TBM-Lab, Dipartimento di Bioingegneria, Politecnico di Milano University, Milano, Italy; 2Hospital Universitario de Getafe – CIBERES, Madrid, Spain; 3CIBER de Enfermedades Respiratorias, Bunyola, Spain; 4Department of Experimental Medicine, University of Milan, Bicocca, Italy; 5Department of Perioperative Medicine and Intensive Care, San Gerardo Hospital, Monza (MI, Italy; 6Critical Care Center, Sabadell Hospital, Corporació Sanitaria Universitaria Parc Tauli, Universitat Autonoma de Barcelona, CIBERES, Spain; 7Department of Pneumology, Hospital Clinic, IDIBAPS, Barcelona, Spain; 8Unitat de Biofísica i Bioenginyeria, Facultat de Medicina, Universidad de Barcelona-IDIBAPS, Barcelona, Spain; 9Institut de Bioenginyeria de Catalunya, Barcelona, SpainAbstract: Even if the performance of a given ventilator has been evaluated in the laboratory under very well controlled conditions, inappropriate maintenance and lack of long-term stability and accuracy of the ventilator sensors may lead to ventilation errors in actual clinical practice. The aim of this study was to evaluate the actual performances of ventilators during clinical routines. A resistance (7.69 cmH2O/L/s – elastance (100 mL/cmH2O test lung equipped with pressure, flow, and oxygen concentration sensors was connected to the Y-piece of all the mechanical ventilators available for patients in four intensive care units (ICUs; n = 66. Ventilators were set to volume-controlled ventilation with tidal volume = 600 mL, respiratory rate = 20 breaths/minute, positive end-expiratory pressure (PEEP = 8 cmH2O, and oxygen fraction = 0.5. The signals from the sensors were recorded to compute the ventilation parameters. The average ± standard deviation and range (min–max of the ventilatory parameters were the following: inspired

  17. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability

    Directory of Open Access Journals (Sweden)

    Bartels Ronald HMA

    2013-01-01

    Full Text Available Abstract Background Incomplete cervical cord syndrome without spinal instability is a very devastating event for the patient and the family. It is estimated that up to 25% of all traumatic spinal cord lesions belong to this category. The treatment for this type of spinal cord lesion is still subject of discussion. From a biological point of view early surgery could prevent secondary damage due to ongoing compression of the already damaged spinal cord. Historically, however, conservative treatment was propagated with good clinical results. Proponents for early surgery as well those favoring conservative treatment are still in debate. The proposed trial will contribute to the discussion and hopefully also to a decrease in the variability of clinical practice. Methods/Design A randomized controlled trial is designed to compare the clinical outcome of early surgical strategy versus a conservative approach. The primary outcome is clinical outcome according to mJOA. This also measured by ASIA score, DASH score and SCIM III score. Other endpoints are duration of the stay at a high care department (medium care, intensive care, duration of the stay at the hospital, complication rate, mortality rate, sort of rehabilitation, and quality of life. A sample size of 36 patients per group was calculated to reach a power of 95%. The data will be analyzed as intention-to-treat at regular intervals, but the end evaluation will take place at two years post-injury. Discussion At the end of the study, clinical outcomes between treatments attitudes can be compared. Efficacy, but also efficiency can be determined. A goal of the study is to determine which treatment will result in the best quality of life for the patients. This study will certainly contribute to more uniformity of treatment offered to patients with a special sort of spinal cord injury. Trial Registration Gov: NCT01367405

  18. Metachronous multicentric giant-cell tumor of the bone in the lower limb. Case report and Ki-67 immunohistochemistry study.

    Science.gov (United States)

    Rousseau, Marc-Antoine; Handra-Luca, Adriana; Lazennec, Jean-Yves; Catonné, Yves; Saillant, Gérard

    2004-07-01

    Multicentric giant-cell tumors of the bone (GCTs) are rare. Little is known about the mechanisms by which these tumors spread and how 1% of GCT turn out to be multicentric. We report the case of a 19-year-old woman with metachronous multiple and recurrent GCTs that were unusual in their pattern of progression along the right lower limb over a 23-year period. Histology showed no evidence of malignant transformation. The treatment was repeated curettage and packing with cement. This did not permit a wide surgical margin, but avoided amputation and preserved full limb function. We tested the proliferation index marker Ki-67 in the tumor specimens. Ki-67 expression was limited to the mononuclear cell component of the tumors. The proliferation index was similar in each new tumor and higher in recurrences for each location. In this case, proliferation was initially low in the new tumor location, despite the time difference and independent from the initial clone evolution. Proliferation index increased in recurrent GCTs after marginal margin resection.

  19. Improving the economic value of photographic screening for optical coherence tomography-detectable macular oedema: a prospective, multicentre, UK study.

    Science.gov (United States)

    Olson, J; Sharp, P; Goatman, K; Prescott, G; Scotland, G; Fleming, A; Philip, S; Santiago, C; Borooah, S; Broadbent, D; Chong, V; Dodson, P; Harding, S; Leese, G; Styles, C; Swa, K; Wharton, H

    2013-11-01

    To determine the best photographic surrogate markers for detecting sight-threatening macular oedema (MO) in people with diabetes attending UK national screening programmes. A multicentre, prospective, observational cohort study of 3170 patients with photographic signs of diabetic retinopathy visible within the macular region [exudates within two disc diameters, microaneurysms/dot haemorrhages (M/DHs) and blot haemorrhages (BHs)] who were recruited from seven study centres. All patients were recruited and imaged at one of seven study centres in Aberdeen, Birmingham, Dundee, Dunfermline, Edinburgh, Liverpool and Oxford. Subjects with features of diabetic retinopathy visible within the macular region attending one of seven diabetic retinal screening programmes. Alternative referral criteria for suspected MO based on photographic surrogate markers; an optical coherence tomographic examination in addition to the standard digital retinal photograph. (1) To determine the best method to detect sight-threatening MO in people with diabetes using photographic surrogate markers. (2) Sensitivity and specificity estimates to assess the costs and consequences of using alternative strategies. (3) Modelled long-term costs and quality-adjusted life-years (QALYs). Prevalence of MO was strongly related to the presence of lesions and was roughly five times higher in subjects with exudates or BHs or more than two M/DHs within one disc diameter. Having worse visual acuity was associated with about a fivefold higher prevalence of MO. Current manual screening grading schemes that ignore visual acuity or the presence of M/DHs could be improved by taking these into account. Health service costs increase substantially with more sensitive/less specific strategies. A fully automated strategy, using the automated detection of patterns of photographic surrogate markers, is superior to all current manual grading schemes for detecting MO in people with diabetes. The addition of optical coherence

  20. Treating KSHV-Associated Multicentric Castleman Disease

    Science.gov (United States)

    In this study, patients with KSHV-associated multicentric Castleman disease will receive IV tocilizumab every other week for up to 12 weeks. Patients who do not benefit may go on to receive high-dose AZT and valganciclovir as well.

  1. [Haemorrhage and morbidity associated with the use of tranexamic acid in cardiac surgery: a retrospective, multicentre cohort study].

    Science.gov (United States)

    Peña, J J; Mateo, E; Martín, E; Llagunes, J; Carmona, P; Blasco, L

    2013-03-01

    Postoperative bleeding is common complication, affecting up to 20% of patients, after cardiac bypass surgery. Fibrinolysis is one of the causes of this excessive bleeding, and for this reason the use of tranexamic acid is recommended. The problem with using this is that there are numerous guidelines and differences in the dose to be administered. Our aim was to evaluate whether there were any differences in postoperative bleeding and morbidity after cardiac surgery with the administering of different tranexamic acid doses in three university hospitals. A retrospective, multicentre cohort study was conducted. A total of 146 patients who were subjected to elective cardiac bypass surgery according to the anaesthetic-surgical protocol of each hospital were included in the study. The clinical histories were reviewed, and they were divided into two groups according to the tranexamic acid dose: Group A (high doses), initial dose of 20mg/kg and continuous infusion of 4 mg/kg/hour until closure of the sternotomy. A further 100mg was added to prime the bypass machine. Group B (low doses), initial dose of 10mg/kg followed by a continuous infusion of 2mg/kg/hour until closure of the sternotomy. A further 50mg was added to prime the bypass machine. Variables, such as age, sex, weight, height, type of surgical procedure (valvular, coronary or mixed), haematocrit, INR, and preoperative platelet count, time and temperature of the bypass machine, and haematocrit on sternum closure, were recorded. Among the post-operative variables collected were: debit due to drainage at 6, 12 and 24 hours after surgery, number and type of blood products transfused in the first 24 hours, need for further surgery due to haemorrhage, CVA, TIA, or a new acute myocardial infarction, convulsions, and mortality. The incidence of increased bleeding (patients in the 90 percentile) was higher in Group B at all the study evaluation times (P<.05). The incidence of further surgery due to bleeding, and the need

  2. Atypical multicentric reticulohistiocytosis

    Directory of Open Access Journals (Sweden)

    Mittal R

    1998-01-01

    Full Text Available A 38-year-old male had arthritis since 8 years and erythematous papules, plaques, cutaneous and subcutaneous nodules over face, ears, trunk, and extensors of arms since 2 years, Histopathologically, presence of multiple foreign body giant cells confirmed the clinical diagnosis of multicentric reticulohistiocytosis. Unusual associations were: tapered fingers with depressed scars on their tips, low ESR - (5mm 1st hour. Raynaud′s phenomenon and exaggeration of lesions after methotrexate.

  3. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns.

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

    Abstract Background The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit\\/hyperactivity disorder (ADHD-CT) and 1446 \\'unselected\\' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres) and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities). A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS) interview and the DSM-IV items of the Conners\\' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands) were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband\\/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive

  4. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

    Full Text Available Abstract Background The International Multi-centre ADHD Genetics (IMAGE project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined type of attention deficit/hyperactivity disorder (ADHD-CT and 1446 'unselected' siblings. The aim was to analyse the IMAGE sample with respect to demographic features (gender, age, family status, and recruiting centres and psychopathological characteristics (diagnostic subtype, symptom frequencies, age at symptom detection, and comorbidities. A particular focus was on the effects of the study design and the diagnostic procedure on the homogeneity of the sample in terms of symptom-based behavioural data, and potential consequences for further analyses based on these data. Methods Diagnosis was based on the Parental Account of Childhood Symptoms (PACS interview and the DSM-IV items of the Conners' teacher questionnaire. Demographics of the full sample and the homogeneity of a subsample (all probands were analysed by using robust statistical procedures which were adjusted for unequal sample sizes and skewed distributions. These procedures included multi-way analyses based on trimmed means and winsorised variances as well as bootstrapping. Results Age and proband/sibling ratios differed between participating centres. There was no significant difference in the distribution of gender between centres. There was a significant interaction between age and centre for number of inattentive, but not number of hyperactive symptoms. Higher ADHD symptom frequencies were reported by parents than teachers. The diagnostic symptoms differed from each other in their frequencies. The face-to-face interview was more sensitive than the questionnaire. The differentiation between ADHD-CT probands and unaffected siblings was mainly due to differences in hyperactive

  5. Los implantes MG-OSSEOUS: Estudio multicéntrico retrospectivo MG-OSSEOUS implants: A multicentric retrospective study

    Directory of Open Access Journals (Sweden)

    E. Serrano Caturla

    2006-12-01

    commercial implants. Material and methodology. This is a retrospective multicentric study coordinated by a company called Scientific Management in O&SS (Barcelona, Spain. 1001 dental implants were placed in 247 patients and 328 prostheses were designed between 2004 and 2005, with a follow-up of two years. All implants were loaded with prostheses. We detail and analyze each implant, according to the diameter, length, position, surgical timing, loadings, design and types of prostheses and complementary surgical procedures, either synchronic or metachronic. Results. After the statistical method was homogenized, we were able to report an overall implant survival rate of 97.8% with monitoring of two years. The failures depending on the peculiarities of each clinical case are provided. No prosthetic failures are reported. Discussion. The criteria and indications applied by the professionals to the MG-OSSEOUS implants are standardized depending on the clinical case. Our results are compared with the international scientific literature, past and present, with these procedures totally agreeing with those found in the history of implantology. Finally, our survey is compared with those published by the Branemark team. Conclusion. The mixture between the quality of the MGOSSEOUS implants and the scientifically supported criteria regarding the implants, reveals an implant failure of 2.2% over two years, with a survival of 100% of both the replaced implants and the loaded prostheses.

  6. Ferroquine and artesunate in African adults and children with Plasmodium falciparum malaria: a phase 2, multicentre, randomised, double-blind, dose-ranging, non-inferiority study.

    Science.gov (United States)

    Held, Jana; Supan, Christian; Salazar, Carmen L O; Tinto, Halidou; Bonkian, Léa N; Nahum, Alain; Moulero, Bancole; Sié, Ali; Coulibaly, Boubacar; Sirima, Sodiomon B; Siribie, Mohamadou; Otsyula, Nekoye; Otieno, Lucas; Abdallah, Ahmed M; Kimutai, Robert; Bouyou-Akotet, Marielle; Kombila, Maryvonne; Koiwai, Kimiko; Cantalloube, Cathy; Din-Bell, Chantal; Djeriou, Elhadj; Waitumbi, John; Mordmüller, Benjamin; Ter-Minassian, Daniel; Lell, Bertrand; Kremsner, Peter G

    2015-12-01

    Artemisinin-based combination therapies (ACTs) are the recommended first-line treatment for uncomplicated Plasmodium falciparum malaria. Ferroquine is a new combination partner for fast-acting ACTs such as artesunate. We aimed to assess different doses of ferroquine in combination with artesunate against uncomplicated P falciparum malaria in a heterogeneous population in Africa. We did a phase 2, multicentre, parallel-group, double-blind, randomised, dose-ranging non-inferiority trial at eight African hospitals (two in Gabon, three in Burkina Faso, one in Benin, and two in Kenya). We recruited patients presenting with acute P falciparum monoinfection (1000-200,000 parasites per μL), and a central body temperature of at least 37·5°C or history of fever in the past 24 h. We assessed patients in two sequential cohorts: cohort 1 contained adults (bodyweight >50 kg) and adolescents (aged ≥14 years, >30 kg), and cohort 2 contained children (aged 2-13 years, 15-30 kg). We randomly assigned patients (1:1:1:1) to receive artesunate 4 mg/kg per day plus ferroquine 2 mg/kg, 4 mg/kg, or 6 mg/kg, given double-blind once per day for 3 days, or ferroquine monotherapy 4 mg/kg per day given single-blind (ie, allocation was only masked from the patient) once per day for 3 days. We did 14 patient visits (screening, 3 treatment days and 48 h post-treatment surveillance, a visit on day 7, then one follow-up visit per week until day 63). The primary endpoint was non-inferiority of treatment in terms of PCR-corrected cure rate against a reference value of 90%, with a 10% non-inferiority margin, assessed in patients treated without major protocol deviations for parasitologically confirmed malaria. We assessed safety in all treated patients. This study is registered with ClinicalTrials.gov, number NCT00988507, and is closed. Between Oct 16, 2009, and Sept 22, 2010, we randomly assigned 326 eligible patients to treatment groups, with last follow-up visit on Dec 1, 2010. 284 patients

  7. Re-evaluation and modification of the Stuivenberg Hospital Acute Renal Failure (SHARF) scoring system for the prognosis of acute renal failure: an independent multicentre, prospective study.

    Science.gov (United States)

    Lins, R L; Elseviers, M M; Daelemans, R; Arnouts, P; Billiouw, J-M; Couttenye, M; Gheuens, E; Rogiers, P; Rutsaert, R; Van der Niepen, P; De Broe, M E

    2004-09-01

    A prognostic scoring system for hospital mortality in acute renal failure (Stuivenberg Hospital Acute Renal Failure, SHARF score) was developed in a single-centre study. The scoring system consists of two scores, for the time of diagnosis of acute renal failure (ARF) and for 48 h later, each originally based on four parameters (age, serum albumin, prothrombin time and heart failure). The scoring system was now tested and adapted in a prospective study. The study involved eight intensive care units. We studied 293 consecutive patients with ARF in 6 months. Their mortality was 50.5%. The causes of ARF were medical in 184 (63%) patients and surgical in 108 (37%). In the latter group, 74 (69%) patients underwent cardiac and 19 (18%) vascular surgery. As the performance of the original SHARF scores was much lower in the multicentre study than in the original single-centre study, we re-analysed the multicentre data to customize the original model for the population studied. The independent variables were the score developed in the original study plus all additonal parameters that were significant on univariate analysis. The new multivariate analysis revealed an additional subset of three parameters for inclusion in the model (serum bilirubin, sepsis and hypotension). For the modified SHARF II score, r(2) was 0.27 at 0 and 0.33 at 48 h, respectively, the receiver operating characteristic (ROC) values were 0.82 and 0.83, and the Hosmer-Lemeshow goodness-of-fit P values were 0.19 and 0.05. After customizing and by using two scoring moments, this prediction model for hospital mortality in ARF is useful in different settings for comparing groups of patients and centres, quality assessment and clinical trials. We do not recommend its use for individual patient prognosis.

  8. Multicentre study evaluating the non-inferiority of the new paediatric formulation of artesunate/amodiaquine versus artemether/lumefantrine for the management of uncomplicated Plasmodium falciparum malaria in children in Cameroon, Ivory Coast and Senegal.

    Science.gov (United States)

    Faye, Babacar; Kuété, Thomas; Kiki-Barro, Christiane P; Tine, Roger C; Nkoa, Thérèse; Ndiaye, Jean Louis A; Kakpo, Claude A; Sylla, Khadime; El Menan, Hervé; Gaye, Oumar; Faye, Oumar; Same-Ekobo, Albert; Moussa, Koné

    2012-12-27

    This multicentre study was carried out in Cameroon, Ivory Coast and Senegal to evaluate the non-inferiority of the new paediatric formulation of artesunate/amodiaquine (AS+AQ)(Camoquin-Plus Paediatric®) in suspension form versus artemether/lumefantrine (AL)(Coartem®) in the management of African children with uncomplicated falciparum malaria. It was an open randomized trial including children aged between 7 months and 7 years. The endpoints were Adequate Clinical and Parasitological Response (ACPR) at day 28, the clinical and biological tolerability. Statistical analyses were done in Intention To Treat (ITT) and in Per protocol (PP). At the end of the study 481 patients were enrolled in the three countries (249 in the AS+AQ arm and 232 in the AL arm). ACRP in ITT after PCR correction did not show any statistical difference between the two groups with 97.6% for AS+AQ versus 94.8% for AL. In the PP analysis, the corrected ACRP were respectively 98.7% and 96.9% for the two regimens. The clinical tolerance was good without significant difference. Anaemia was significantly higher at D7 in the two groups compared to D0. This study demonstrates the non-inferiority of AS+AQ versus AL, its efficacy and tolerance in the management of uncomplicated Plasmodium falciparum malaria in African children.

  9. 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.)

  10. Multicentre evaluation of multidisciplinary team meeting agreement on diagnosis in diffuse parenchymal lung disease: a case-cohort study

    DEFF Research Database (Denmark)

    Walsh, Simon L F; Wells, Athol U; Desai, Sujal R;

    2016-01-01

    . This difference is of particular importance, because accurate and consistent diagnoses of IPF are needed if clinical outcomes are to be optimised. Inter-multidisciplinary team agreement for a diagnosis of hypersensitivity pneumonitis is low, highlighting an urgent need for standardised diagnostic guidelines......-multidisciplinary team agreement for the diagnosis of diffuse parenchymal lung disease. METHODS: We did a multicentre evaluation of clinical data of patients who presented to the interstitial lung disease unit of the Royal Brompton and Harefield NHS Foundation Trust (London, UK; host institution) and required...... multidisciplinary team meeting (MDTM) characterisation between March 1, 2010, and Aug 31, 2010. Only patients whose baseline clinical, radiological, and, if biopsy was taken, pathological data were undertaken at the host institution were included. Seven MDTMs, consisting of at least one clinician, radiologist...

  11. Randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse

    DEFF Research Database (Denmark)

    Nyström, P-O; Qvist, N; Raahave, D;

    2010-01-01

    BACKGROUND: : This multicentre randomized clinical trial studied how symptoms improved after either stapled anopexy or diathermy excision of haemorrhoids. METHODS: : The study involved 18 hospitals in Sweden, Denmark and the UK. Some 207 patients were randomized to either anopexy or Milligan-Morg...

  12. Randomized controlled observer-blinded treatment of chronic foot eczema with iontophoresis and bath-PUVA

    NARCIS (Netherlands)

    Tupker, Ron A; Coenraads, Pieter Jan; Zanen, Pieter; Schuttelaar, Marielouise

    2013-01-01

    The aim of this study was to investigate the effect of iontophoresis combined with local psoralen plus ultraviolet A (PUVA) therapy in chronic foot eczema. A randomized, observer-blinded, multi-centre study was conducted in 48 patients with chronic moderate-to-severe foot eczema randomized to one of

  13. 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...... (PMS). Methods: Femal, 160 mg twice-daily, was given for four menstrual cycles to 50 women, and placebo to 51 women. PSD were evaluated on a visual analogue scale prior to and after the four cycles. The effect on overall PMS symptoms was assessed with the Steiner premenstrual tension syndrome (PMTS......) self-rating questionnaire. The results were analysed statistically based on intention to treat. Results: Femal treatment resulted in a significant reduction in PSD (P 0.05). In a subgroup analysis of women with irritability as their main PMS...

  14. Intra-articular hyaluronan is without clinical effect in knee osteoarthritis: a multicentre, randomised, placebo-controlled, double-blind study of 337 patients followed for 1 year

    DEFF Research Database (Denmark)

    Jørgensen, Anette; Stengaard-Pedersen, Kristian; Simonsen, Lars Ole;

    2010-01-01

    Objective To examine the long-term efficacy and safety of five intra-articular injections with hyaluronan in knee osteoarthritis. Methods A multicentre, randomised, placebo-controlled double-blind study of 337 patients fulfilling the American College of Rheumatology (ACR) criteria for knee...... efficacy parameter. LFI, pain on walking 50 m based on visual analogue scale (VAS pain 50 m), paracetamol consumption, patients' global assessment, Nottingham health profile, joint effusion and number of responders were secondary efficacy parameters. The efficacy parameters were analysed by intention...... to treat (ITT) and per protocol (PP). All adverse events (AE) were recorded as safety parameters. Results Time to recurrence showed no significant treatment effect (ITT analysis, p = 0.26). Change from baseline in LFI and VAS pain 50 m for the ITT population showed no treatment effect. Paracetamol...

  15. Increased incidence of hypotension in elderly patients who underwent emergency airway management: an analysis of a multi-centre prospective observational study.

    Science.gov (United States)

    Hasegawa, Kohei; Hagiwara, Yusuke; Imamura, Taichi; Chiba, Takuyo; Watase, Hiroko; Brown, Calvin A; Brown, David Fm

    2013-01-01

    Although the number of elderly increases disproportionately throughout the industrialised nations and intubation-related cardiovascular compromise is associated with hospital mortality, no emergency medicine literature has reported the direction and magnitude of effect of advanced age on post-intubation hypotension. We seek to determine whether advanced age is associated with an increased rate of hypotension at airway management in emergency departments (EDs). We conducted an analysis of a multi-centre prospective observational study of 13 Japanese EDs from April 2010 to March 2012. Inclusion criteria were all adult non-cardiac-arrest patients who underwent emergency intubation. We excluded patients in whom airway management was performed for shock or status asthmaticus as the principal indication. Patients were divided into two groups defined a priori: age ≥ 65 years old (elderly group) and age airway management at 13 EDs. Among these, the database recorded 3,872 intubations (capture rate 96%). Of 1,903 eligible patients, 975 patients were age ≥ 65 years (51%) and 928 patients were age advanced age had an adjusted OR for post-intubation hypotension of 2.6 (95% CI, 1.3-5.6; P = 0.01). In this large multi-centre study of ED patients who underwent emergent airway management, we found that elderly patients have a significantly higher risk of post-intubation hypotension. These data provide implications for the education and practice of ED airway management that may lead to better clinical outcomes and improved patient safety.

  16. Postradiation multicentric osteosarcoma

    Energy Technology Data Exchange (ETDEWEB)

    Tillotson, C.; Rosenberg, A.; Gebhardt, M.; Rosenthal, D.I.

    1988-07-01

    The oncogenic effects of radiation are well-established. Osteosarcomas and fibrosarcomas are the two most common histologic types of secondary sarcoma. In this article a case of postradiation osteosarcoma is presented in which four discrete foci of sarcomatous transformation have occurred in the tibia and fibula after irradiation for a rhabdomyosarcoma of the calf 8 years earlier. A review of the literature reveals no similar case. Although synchronous, multifocal osteosarcoma without prior radiation has been described, this case differs in clinical, radiographic, and pathologic features; it best fits the description of postradiation multicentric osteosarcoma.

  17. Postradiation multicentric osteosarcoma.

    Science.gov (United States)

    Tillotson, C; Rosenberg, A; Gebhardt, M; Rosenthal, D I

    1988-07-01

    The oncogenic effects of radiation are well-established. Osteosarcomas and fibrosarcomas are the two most common histologic types of secondary sarcoma. In this article a case of postradiation osteosarcoma is presented in which four discrete foci of sarcomatous transformation have occurred in the tibia and fibula after irradiation for a rhabdomyosarcoma of the calf 8 years earlier. A review of the literature reveals no similar case. Although synchronous, multifocal osteosarcoma without prior radiation has been described, this case differs in clinical, radiographic, and pathologic features; it best fits the description of postradiation multicentric osteosarcoma.

  18. Diagnostic accuracy of MRI in adults with suspect brachial plexus lesions: A multicentre retrospective study with surgical findings and clinical follow-up as reference standard

    Energy Technology Data Exchange (ETDEWEB)

    Tagliafico, Alberto, E-mail: alberto.tagliafico@unige.it [Institute of Anatomy, Department of Experimental Medicine, University of Genoa, Largo Rosanna Benzi 8, 16132 Genoa (Italy); Succio, Giulia; Serafini, Giovanni [Department of Radiology, Santa Corona Hospital, Pietra Ligure, Italy via XXV Aprile, 38- Pietra Ligure, 17027 Savona (Italy); Martinoli, Carlo [Radiology Department, DISC, Università di Genova, Largo Rosanna Benzi 8, 16138 Genova (Italy)

    2012-10-15

    Objective: To evaluate brachial plexus MRI accuracy with surgical findings and clinical follow-up as reference standard in a large multicentre study. Materials and methods: The research was approved by the Institutional Review Boards, and all patients provided their written informed consent. A multicentre retrospective trial that included three centres was performed between March 2006 and April 2011. A total of 157 patients (men/women: 81/76; age range, 18–84 years) were evaluated: surgical findings and clinical follow-up of at least 12 months were used as the reference standard. MR imaging was performed with different equipment at 1.5 T and 3.0 T. The patient group was divided in five subgroups: mass lesion, traumatic injury, entrapment syndromes, post-treatment evaluation, and other. Sensitivity, specificity with 95% confidence intervals (CIs), positive predictive value (PPV), pre-test-probability (the prevalence), negative predictive value (NPV), pre- and post-test odds (OR), likelihood ratio for positive results (LH+), likelihood ratio for negative results (LH−), accuracy and post-test probability (post-P) were reported on a per-patient basis. Results: The overall sensitivity and specificity with 95% CIs were: 0.810/0.914; (0.697–0.904). Overall PPV, pre-test probability, NPV, LH+, LH−, and accuracy: 0.823, 0.331, 0.905, 9.432, 0.210, 0.878. Conclusions: The overall diagnostic accuracy of brachial plexus MRI calculated on a per-patient base is relatively high. The specificity of brachial plexus MRI in patients suspected of having a space-occupying mass is very high. The sensitivity is also high, but there are false-positive interpretations as well.

  19. The impact of study design and diagnostic approach in a large multi-centre ADHD study: Part 2: Dimensional measures of psychopathology and intelligence

    NARCIS (Netherlands)

    Muller, U.C.; Asherson, P.; Banaschewski, T.; Buitelaar, J.K.; Ebstein, R.P.; Eisenberg, J.; Gill, M.; Manor, I.; Miranda, A.; Oades, R.D.; Roeyers, H.; Rothenberger, A.; Sergeant, J.A.; Sonuga-Barke, E.J.S.; Thompson, M.; Faraone, S.V.; Steinhausen, H.C.

    2011-01-01

    BACKGROUND: The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with ADHD and 1446 un

  20. The impact of study design and diagnostic approach in a large multi-centre ADHD study. Part 1: ADHD symptom patterns

    NARCIS (Netherlands)

    Muller, U.C.; Asherson, P.; Banaschewski, T.; Buitelaar, J.K.; Ebstein, R.P.; Eisenberg, J.; Gill, M.; Manor, I.; Miranda, A.; Oades, R.D.; Roeyers, H.; Rothenberger, A.; Sergeant, J.A.; Sonuga-Barke, E.J.S.; Thompson, M.; Faraone, S.V.; Steinhausen, H.C.

    2011-01-01

    BACKGROUND: The International Multi-centre ADHD Genetics (IMAGE) project with 11 participating centres from 7 European countries and Israel has collected a large behavioural and genetic database for present and future research. Behavioural data were collected from 1068 probands with the combined typ

  1. Providing effective trauma care: the potential for service provider views to enhance the quality of care (qualitative study nested within a multicentre longitudinal quantitative study).

    Science.gov (United States)

    Beckett, Kate; Earthy, Sarah; Sleney, Jude; Barnes, Jo; Kellezi, Blerina; Barker, Marcus; Clarkson, Julie; Coffey, Frank; Elder, Georgina; Kendrick, Denise

    2014-07-08

    To explore views of service providers caring for injured people on: the extent to which services meet patients' needs and their perspectives on factors contributing to any identified gaps in service provision. Qualitative study nested within a quantitative multicentre longitudinal study assessing longer term impact of unintentional injuries in working age adults. Sampling frame for service providers was based on patient-reported service use in the quantitative study, patient interviews and advice of previously injured lay research advisers. Service providers' views were elicited through semistructured interviews. Data were analysed using thematic analysis. Participants were recruited from a range of settings and services in acute hospital trusts in four study centres (Bristol, Leicester, Nottingham and Surrey) and surrounding areas. 40 service providers from a range of disciplines. Service providers described two distinct models of trauma care: an 'ideal' model, informed by professional knowledge of the impact of injury and awareness of best models of care, and a 'real' model based on the realities of National Health Service (NHS) practice. Participants' 'ideal' model was consistent with standards of high-quality effective trauma care and while there were examples of services meeting the ideal model, 'real' care could also be fragmented and inequitable with major gaps in provision. Service provider accounts provide evidence of comprehensive understanding of patients' needs, awareness of best practice, compassion and research but reveal significant organisational and resource barriers limiting implementation of knowledge in practice. Service providers envisage an 'ideal' model of trauma care which is timely, equitable, effective and holistic, but this can differ from the care currently provided. Their experiences provide many suggestions for service improvements to bridge the gap between 'real' and 'ideal' care. Using service provider views to inform service design

  2. WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: results of an open label, non-comparative, multi-centric, post marketing observational study.

    Science.gov (United States)

    Kumbla, D K; Kumar, S; Reddy, Y V; Trailokya, A; Naik, M

    2014-01-01

    Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management. To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to olmesartan. All reported adverse events were recorded. A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study. Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  3. WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: Results of an open label, non-comparative, multi-centric, post marketing observational study

    Science.gov (United States)

    Kumbla, D.K.; Kumar, S.; Reddy, Y.V.; Trailokya, A.; Naik, M.

    2014-01-01

    Background Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management. Objective To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. Material and methods An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140 mmHg and diastolic BP (DBP) to <90 mmHg at 3 and 6 months after initiation of treatment with olmesartan. All reported adverse events were recorded. Results A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p < 0.0001) with olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study. Conclusion Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. PMID:24973841

  4. Eficacia del dipéptido N(2-L-Alanil-L-glutamina en los pacientes traumáticos ingresados en la UCI: estudio prospectivo, multicéntrico, aleatorizado y doble ciego; hipótesis y protocolo Efficacy of the dipeptide N(2-L-Alanyl-L-glutamine in traumatic patients admitted to the ICU: a prospective, randomized, double-blind, multicentre study

    Directory of Open Access Journals (Sweden)

    J. Pérez-Bárcena

    2012-02-01

    in different groups of patients according to the severity and the plasma levels of glutamine. 2 Record all the adverse events due to the intravenous administration of glutamine. Methods: prospective, randomized, doble-blind and multicenter study with two parallel groups: placebo and treatment group. The patients who fulfill the inclusion criteria will receive either glutamine or placebo, independently of the type on nutrition. Glutamine will be administered as a pharmaconutrient at 0.5 g/kg/day during 5 days as a continous perfusion.

  5. Quantification of FDG PET studies using standardised uptake values in multi-centre trials : effects of image reconstruction, resolution and ROI definition parameters

    NARCIS (Netherlands)

    Westerterp, Marinke; Pruim, Jan; Oyen, Wim; Hoekstra, Otto; Paans, Anne; Visser, Eric; van Lanschot, Jan; Sloof, Gerrit; Boellaard, Ronald

    2007-01-01

    Purpose: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multicentre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of diffe

  6. Collaborative Depression Trial (CADET: multi-centre randomised controlled trial of collaborative care for depression - study protocol

    Directory of Open Access Journals (Sweden)

    Kessler David

    2009-10-01

    Full Text Available Abstract Background Comprising of both organisational and patient level components, collaborative care is a potentially powerful intervention for improving depression treatment in UK primary Care. However, as previous models have been developed and evaluated in the United States, it is necessary to establish the effect of collaborative care in the UK in order to determine whether this innovative treatment model can replicate benefits for patients outside the US. This Phase III trial was preceded by a Phase II patient level RCT, following the MRC Complex Intervention Framework. Methods/Design A multi-centre controlled trial with cluster-randomised allocation of GP practices. GP practices will be randomised to usual care control or to "collaborative care" - a combination of case manager coordinated support and brief psychological treatment, enhanced specialist and GP communication. The primary outcome will be symptoms of depression as assessed by the PHQ-9. Discussion If collaborative care is demonstrated to be effective we will have evidence to enable the NHS to substantially improve the organisation of depressed patients in primary care, and to assist primary care providers to deliver a model of enhanced depression care which is both effective and acceptable to patients. Trial Registration Number ISRCTN32829227

  7. Cost-effectiveness of the Australian Medical Sheepskin for the prevention of pressure ulcers in somatic nursing home patients: study protocol for a prospective multi-centre randomised controlled trial (ISRCTN17553857

    Directory of Open Access Journals (Sweden)

    Montgomery Ken

    2008-01-01

    Full Text Available Abstract Background Pressure ulcers are a major problem, especially in nursing home patients, although they are regarded as preventable and there are many pressure relieving methods and materials. One such pressure relieving material is the recently developed Australian Medical Sheepskin, which has been shown in two randomized controlled trials 12 to be an effective intervention in the prevention of sacral pressure ulcers in hospital patients. However, the use of sheepskins has been debated and in general discouraged by most pressure ulcer working groups and pressure ulcer guidelines, but these debates were based on old forms of sheepskins. Furthermore, nothing is yet known about the (cost-effectiveness of the Australian Medical sheepskin in nursing home patients. The objective of this study is to assess the effects and costs of the use of the Australian Medical Sheepskin combined with usual care with regard to the prevention of sacral pressure ulcers in somatic nursing home patients, versus usual care only. Methods/Design In a multi-centre randomised controlled trial 750 patients admitted for a primarily somatic reason to one of the five participating nursing homes, and not having pressure ulcers on the sacrum at admission, will be randomized to either usual care only or usual care plus the use of the Australian Medical Sheepskin as an overlay on the mattress. Outcome measures are: incidence of sacral pressure ulcers in the first month after admission; sacrum pressure ulcer free days; costs; patient comfort; and ease of use. The skin of all the patients will be observed once a day from admission on for 30 days. Patient characteristics and pressure risk scores are assessed at admission and at day 30 after it. Additional to the empirical phase, systematic reviews will be performed in order to obtain data for economic weighting and modelling. The protocol is registered in the Controlled Trial Register as ISRCTN17553857.

  8. Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R B; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John

    2016-09-08

    One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation

  9. 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...

  10. Goal-directed fluid management based on stroke volume variation and stroke volume optimization during high-risk surgery : a pilot multicentre randomized controlled trial

    NARCIS (Netherlands)

    Scheeren, Thomas; Wiesenack, Christoph; Gerlach, H.; Marx, G.

    2011-01-01

    Introduction: Perioperative hemodynamic optimization has been shown to be useful to improve the postoperative outcome of patients undergoing major surgery. We designed a pilot study in patients undergoing major abdominal, urologic or vascular surgery to investigate the effects of a goal-directed (GD

  11. Factors which influence treatment initiation for pulmonary non-tuberculous mycobacterium infection in HIV negative patients; a multicentre observational study.

    Science.gov (United States)

    Rawson, Timothy M; Abbara, Aula; Kranzer, Katharina; Ritchie, Andrew; Milburn, James; Brown, Tim; Adeboyeku, David; Buckley, Jim; Davidson, Robert N; Berry, Matthew; Kon, Onn Min; John, Laurence

    2016-11-01

    Clinical, radiological and microbiological criteria inform diagnosis of pulmonary Non-Tuberculous Mycobacteria (NTM) disease and treatment decisions. This multicentre, review aims to characterise NTM disease meeting ATS/IDSA criteria and define factors associated with initiation of treatment. Sputum samples growing NTM from 5 London hospitals between 2010 and 2014 were identified. Data for HIV-negative individuals meeting ATS/IDSA guidelines for pulmonary NTM disease were extracted. Associations between clinical variables and treatment decision were investigated using Chi-squared, Fishers-exact or Mann Whitney tests. Factors associated with treatment in univariate analysis (p < 0.150) were included in a multivariate logistic regression model. NTM were identified from 817 individuals' sputum samples. 108 met ATS/IDSA criteria. 42/108 (39%) were initiated on treatment. Median age was 68 (56-78) in the cohort. On multivariate analysis, factors significantly associated with treatment of pulmonary NTM infection were: Cavitation on HRCT (OR: 6.49; 95% CI: 2.36-17.81), presenting with night sweats (OR 4.18; 95% CI: 1.08-16.13), and presenting with weight loss (OR 3.02; 95% CI: 1.15-7.93). Of those treated, 18(43%) have completed treatment, 9(21%) remain on treatment, 10(24%) stopped due to side effects, 5(12%) died during treatment. Mortality was 31% (n = 13) in treated versus 21% (n = 14) in the non-treated cohort. Subgroup analysis of individual NTM species did not observe any differences in treatment initiation or outcomes between groups. Decision to treat pulmonary NTM infection requires clinical judgement when interpreting clinical guidelines. Factors independently associated with decision to treat in this HIV-negative cohort include cavitation on HRCT and presenting with night sweats or weight loss. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2014-07-01

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

  13. 中药参松养心胶囊改善冠心病患者异位心律的随机双盲、阳性药对照、多中心临床研究%A random double blind,positive medication control and multi-centre clinical study on the effects of traditional Chinese medicine Shensong Yangxin capsule in improving ectopic cardiac rhythm in coronary heart disease patients

    Institute of Scientific and Technical Information of China (English)

    徐贵成; 霍保民; 吴以岭; 高学东; 王秋风; 尹倚艰; 齐晓琳; 杨立波

    2004-01-01

    OBJECTIVE: To discuss the clinical therapeutic effectiveness and safety of Ginseng-spikenard heart nourishing capsule to ventricular extrasystole in coronary heart disease. METHODS:206 cases of patients accorded with inclusive criteria from outpatient or inpatient department were randomly allocated with randomly double blind double analogue into therapy group with 103 cases and treated with the capsule(4 capsules,3 times a day). 103 cases were allocated into control group and treated with Xinluning(2 tablets,3 times a day). Therapeutic effectiveness and toxic side effects on ventricular extrasystole,main symptoms,and electrocardiogram were assessed after 4 weeks. RESULTS:The effective rate of ventricular extrasystole in the therapy group was 35.0% (36/103) and the total effective rate was 69.0% (71/103), which were markedly higher than those of the control group[18.4% (19/103) and 48.5% (50/103) respectively](Z=3.261,P=0.001). CONCLUSION:The therapeutic effectiveness of the capsule in the treatment of ventricular extrasystole in coronary heart disease was obviously better than that of Xinluning,and the side effects was not found in the routine test of blood,urine,stool and liver,and kidney functions.%目的:探讨参松养心胶囊对冠心病室性期前收缩的临床疗效和安全性. 方法:对符合纳入标准的 206例门诊或住院患者,采用随机双盲双模拟对照,按 1:1随机分为治疗组 103例,给予参松养心胶囊( 4粒, 3次 /d),对照组 103例给予心律宁片( 2片, 3次 /d). 4周后进行室性期前收缩、主要症状、心电图等疗效及毒副作用的评估. 结果:治疗组室性期前收缩显效率 35.0%( 36/103),总有效率 69.0%( 71/103),明显优于对照组显效率 18.4%( 19/103)与总有效率 48.5%( 50/103)( Z=- 3.261, P=0.001). 结论:参松养心胶囊治疗冠心病室性期早搏明显优于心律宁片,未见对血、尿、便常规,肝、肾功能等的不良影响.

  14. Efficacy and safety of tonabersat, a gap-junction modulator, in the acute treatment of migraine: a double-blind, parallel-group, randomized study