[PDF] Top 20 Chimney Trial: study protocol for a randomized controlled trial

... the study group ac- cording to a computer-generated list, compiled by a bio- statistician who is not involved in the clinical care of trial ...the study is used to randomize the ... See full document

... The efficacy of betamethasone will be assessed by com- paring the primary and secondary outcomes of each group. Efficacy analysis will be conducted based on intention-to-treat and per-protocol principle. ... See full document

... previous study in Nigeria found that about four out of five persons with severe mental disorders, particularly depression, had re- ceived no treatment in the previous year and that, among those who did, only about ... See full document

... the trial through regular review of adverse event ...the randomized comparisons have provided both (i) 'proof beyond reasonable doubt' that for all, or some, the treatment is clearly indicated or clearly ... See full document

... present study aims to test the relative efficacy of two components added to TF- CBT focussing on parent-related aspects of IPV, namely parenting and parent-child interactions, and thereby pro- vides crucial ... See full document

... the trial through regular review of adverse event ...the randomized comparisons have provided both (i) 'proof beyond reasonable doubt' that for all, or some, the treatment is clearly indicated or clearly ... See full document

... no randomized controlled trials (RCTs) have been ...a protocol for an RCT comparing a standard suture closure to mesh reinforcement with biological intra-abdominal mesh after stoma closure ... See full document

... this trial will provide evidence for the effectiveness of NET in treating trauma-related symptoms in immigrant children affected by ...The trial will also generate insights into the complex relationships ... See full document

... each study site. Study site is the stratification vari- able for this randomization ...each study site, a 1:1 allocation ...Each study site has a predefined set of patients to ...each ... See full document

... The study has been approved by the Institutional Review Broad of the University of Hong Kong/Hospital Authority Hong Kong West Cluster and has been registered under Clinical Trials Registry (trial number ... See full document

... All trainers that provide the TTT program in the study have a Bachelor or Master in psychology or social ser- vices and experience in working with people with ASD. They have taken the 2 day train-the-trainer ... See full document

... a trial involv- ing women considerably leaner [9] and higher rates found in two trials: a trial of a very high risk postpartum group (36 %) [8] and another trial involving older women, enrolled a ... See full document

... This study is approved by the Ethics Committee of Ren Ji Hospital, Shanghai Jiao Tong University School of Medi- ...this trial to interested potential participants in detail and pro- vide them with the ... See full document

... a trial statistician who is not directly involved in the ...the trial statistician will be used to produce randomized allocation ...a randomized permuted block design with block size of 4, 6, ... See full document

... Safety will be monitored through weekly contact: tele- phone calls during weeks 1 and 3 and office visits during weeks 2 and 4. All adverse events will be recorded. The investigator will determine both the severity of ... See full document

... Primary Outcome: The primary analysis will compare the treatment groups on the 24-week HbA1c for the pre-pregnant cohort and on the 34-week HbA1c for the pregnant cohort, controlling for baseline HbA1c in an analysis of ... See full document

... Patients allocated to the dydrogesterone group will receive dydrogesterone 40 mg per os, followed by 10 mg per os three times a day, and an identical-looking pla- cebo will be used in the control group accordingly. Con- ... See full document

... Perioperative management, discharge, and follow-up Perioperative thrombosis prophylaxis will be performed according to current German guidelines [13]. Single- shot antibiotics (ampicillin/sulbactam) will be given 30 ... See full document

... All data will be collected in personal CRFs, which will be stored in the patient’s own hospital. Copies of the completed forms will be sent to our coordinating center (Canisius-Wilhelmina Hospital, Nijmegen). All data ... See full document

... The rates for the primary endpoint: major morbidity, re- intervention and mortality for PC were 6.2, 13.1 and 12.7% respectively in the review and 22.2, 18.5 and 14.8% in our own series. We believe that the 6.2% ... See full document