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

... parallel, randomized controlled trial (RCT) with a 3-month post-treatment assessment (study ...this study will be an active (wait-list) control group that will receive need-based care ... See full document

... Any protocol deviations are reviewed by the PI who de- termines if modifications to the study protocol or consent form are ...capacity. Protocol deviations are reported to the DSMB as ...the ... See full document

... the study sites and have not received any adjuvant oncological treatment due to routine protocol of rectal cancer treatment will be considered for inclusion at 1-month follow-up at the outpatient department ... See full document

... Bi-TPAI trial is a national, multicenter, parallel group, open, non-inferiority, randomized controlled trial that will include 220 patients with HTG-AP, from 17 large tertiary hospitals in ... See full document

... the study coordinator or primary investigator using an online generator (ALEA ...different study sites, so stratifi- cation according to hospital can be ... See full document

... this trial is limited, there are clearly predefined safety limits of PSH incidence and complications to determine when to prematurely finish the trial as unethical to con- ...the trial is designed to ... See full document

... prospective randomized multicenter trial to determine if a retromuscular, preperitoneal mesh at the stoma site prevents parastomal hernia and does not cause unacceptable ... 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

... a randomized controlled trial studying the ef- fectiveness and prospective mechanisms of change of Narrative Exposure Therapy in the treatment of post- traumatic stress symptoms in children affected ... See full document

... training protocol has been developed so that each specific exercise can be modified to obtain three different levels of difficulty in order to provide a safe and individualized training experience for each ... See full document

... be randomized in a 1:1 ratio to receive enteral simvastatin 80 mg or placebo once daily for a maximum of 28 ...to randomized groups will be stratified with respect to hospital of recruitment and vasopressor ... 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

... The limitations of this study are mostly related to typ- ical limitations of this type of clinical trial with a longitu- dinal design, in particular, the sample size. Another limitation is that this type of ... 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

... 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

... Given the possible risks that adolescents with ASD encounter and their problems with access to reliable information resources, several studies on puberty and sexuality in adolescents with ASD emphasize the need for ... See full document

... The Children’s Responses to Trauma Inventory Revised version [90] is a self-report measure for children aged 8– 18 years and consists of 34 items. Children answer, on a 5-point Likert scale, to which extent a reaction to ... See full document

... the trial will be in accordance with CONSORT guide- lines for cluster randomized trials [46, ...as randomized without imputation of miss- ing data, and with due emphasis placed on confidence ... 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

... Every attempt will be made to collect full follow-up data on all women (unless a woman withdraws consent for follow-up data collection). In particular, women will be followed up even after protocol violation. It ... See full document