Trial Methodology

Cross-source consensus on Trial Methodology from 2 sources and 12 claims.

2 sources · 12 claims

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Highlighted claims

The pilot trial targets 40 participants, with 20 participants per arm. — Pilot multicentre open-label randomised controlled trial assessing prevention of recurrent DIverticulitis through the use of pelvic floor PHYSIOtherapy: DIPHYSIO study protocol
The study is a single-site, double-blind, randomized controlled trial conducted at UNC-CH under FDA Investigational New Drug provisions. — Efficacy of the serogroup B Neisseria meningitidis vaccine (4CMenB) in preventing experimental Neisseria gonorrhoeae urethral infection: a double-blind randomised controlled human challenge study protocol
The primary endpoint is the proportion of participants in each arm with laboratory-confirmed N. gonorrhoeae infection during the 10-day post-inoculation period. — Efficacy of the serogroup B Neisseria meningitidis vaccine (4CMenB) in preventing experimental Neisseria gonorrhoeae urethral infection: a double-blind randomised controlled human challenge study protocol
The analysis uses Stata/SE V.18.0. — Pilot multicentre open-label randomised controlled trial assessing prevention of recurrent DIverticulitis through the use of pelvic floor PHYSIOtherapy: DIPHYSIO study protocol
Participants are randomized 1:1 with computer-generated block randomization in blocks of four. — Efficacy of the serogroup B Neisseria meningitidis vaccine (4CMenB) in preventing experimental Neisseria gonorrhoeae urethral infection: a double-blind randomised controlled human challenge study protocol
The trial targets 140 enrolled participants to yield 120 evaluable participants, with 60 per arm. — Efficacy of the serogroup B Neisseria meningitidis vaccine (4CMenB) in preventing experimental Neisseria gonorrhoeae urethral infection: a double-blind randomised controlled human challenge study protocol
Eligible patients are approached using consecutive sampling. — Pilot multicentre open-label randomised controlled trial assessing prevention of recurrent DIverticulitis through the use of pelvic floor PHYSIOtherapy: DIPHYSIO study protocol
Randomisation occurs at discharge using a 1:1 allocation with a maximum tolerated imbalance of three. — Pilot multicentre open-label randomised controlled trial assessing prevention of recurrent DIverticulitis through the use of pelvic floor PHYSIOtherapy: DIPHYSIO study protocol
No a priori power calculation was performed because the study is explicitly a pilot study. — Pilot multicentre open-label randomised controlled trial assessing prevention of recurrent DIverticulitis through the use of pelvic floor PHYSIOtherapy: DIPHYSIO study protocol
The analysis reports confidence intervals rather than p-values to convey precision and uncertainty. — Pilot multicentre open-label randomised controlled trial assessing prevention of recurrent DIverticulitis through the use of pelvic floor PHYSIOtherapy: DIPHYSIO study protocol