Superior Capsule vs Bridging Study
Condition: Rotator Cuff Tears Interventions: Procedure: SCR; Procedure: Bridging Sponsors: University of Calgary; Worker's Compensation Board of Alberta (funding); Canadian Orthopaedic Foundation (funding); Arthroscopy Association of North America (funding) Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - July 16, 2021 Category: Research Source Type: clinical trials
TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis
DiscussionTRAFIC is an MRC-funded trial of a re-purposed treatment demonstrating that it is possible to design, fund and implement a model-based phase I trial in a non-cancer population within conventional research funding tracks and regulatory constraints. The phase I design allows borrowing of information from previous trials, all accumulated data to be utilised in decision-making, verification of operating characteristics through simulation, improved understanding for management and oversight teams through dose transition pathways. The rolling phase II design brings efficiencies in trial conduct including site and monit...
Source: Trials - July 6, 2021 Category: Research Source Type: clinical trials
SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults —a study protocol for a prospective randomized double-blind multicenter clinical trial
DiscussionCurrently, there has been no randomized clinical trial comparing the recurrence rates between an onlay mesh repair and a simple suture repair for small umbilical hernia defects. How to best repair a small umbilical hernia continues to be debated. This trial design should allow for a good assessment of the differences in recurrence rate due to the large sample size and the adequate follow-up. Surgeons ’ concerns surrounding optimal anatomical positioning and fear for larger required dissections are understandable. A small onlay mesh may become an easy and safe method of choice to reduce recurrence rates. Guideli...
Source: Trials - June 22, 2021 Category: Research Source Type: clinical trials
Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov —evaluation of a new tracking tool for the US clinical trial registry
AbstractClinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017 –2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry (ClinicalTrials.gov). Firstly, we developed and evaluated a novel automated tracking tool (clinical-trial...
Source: Trials - June 1, 2021 Category: Research Source Type: clinical trials
