Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs
Without surgical repair, flexor tendon injuries do not heal and patients ’ ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There... (Source: Trials)
Source: Trials - March 16, 2024 Category: General Medicine Authors: Emma Bamford, Hannah Berntsson, Suzanne Beale, Lauren Desoysa, Joseph Dias, Sienna Hamer-Kiwacz, Daniel Hind, Nick Johnson, Amanda Loban, Kaye Molloy, Emma Morvan, Ines Rombach, Anna Selby, Praveen Thokala, Chris Turtle, Stephen Walters & hellip; Tags: Study protocol Source Type: research

Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs
DiscussionFIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes.Trial registrationISRCTN: 10236011 (Source: Trials)
Source: Trials - March 16, 2024 Category: Research Source Type: clinical trials

Heart rate and breathing effects on attention and memory (HeartBEAM): study protocol for a randomized controlled trial in older adults
In healthy people, the “fight-or-flight” sympathetic system is counterbalanced by the “rest-and-digest” parasympathetic system. As we grow older, the parasympathetic system declines as the sympathetic system b... (Source: Trials)
Source: Trials - March 15, 2024 Category: General Medicine Authors: Kaoru Nashiro, Hyun Joo Yoo, Christine Cho, Andy Jeesu Kim, Padideh Nasseri, Jungwon Min, Martin J. Dahl, Noah Mercer, Jeiran Choupan, Paul Choi, Hye Rynn J. Lee, David Choi, Kalekirstos Alemu, Alexandra Ycaza Herrera, Nicole F. Ng, Julian F. Thayer & hel Tags: Study protocol Source Type: research

Mean Arterial Pressure (MAP) Trial: study protocol for a multicentre, randomized, controlled trial to compare three different strategies of mean arterial pressure management during cardiopulmonary bypass
One of the main goals of cardiopulmonary bypass (CPB) is targeting an adequate mean arterial pressure (MAP) during heart surgery, in order to maintain appropriate perfusion pressures in all end-organs. As inhe... (Source: Trials)
Source: Trials - March 15, 2024 Category: General Medicine Authors: Alessandra Francica, Gina Mazzeo, Antonella Galeone, Daniele Linardi, Livio San Biagio, Giovanni Battista Luciani and Francesco Onorati Tags: Study protocol Source Type: research

Correction: Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)
(Source: Trials)
Source: Trials - March 15, 2024 Category: General Medicine Authors: Corinna Engel, Mario R üdiger, Manon J. N. L. Benders, Frank van Bel, Karel Allegaert, Gunnar Naulaers, Dirk Bassler, Katrin Klebermaß-Schrehof, Maximo Vento, Ana Vilan, Mari Falck, Isabella Mauro, Marjo Metsäranta, Sampsa Vanhatalo, Jan Mazela, Tuuli Tags: Correction Source Type: research

Heart rate and breathing effects on attention and memory (HeartBEAM): study protocol for a randomized controlled trial in older adults
DiscussionOur HRV-ER trial was groundbreaking in demonstrating that a behavioral intervention can reduce plasma A β levels relative to a randomized control group. We aim to reproduce these findings while testing effects on brain clearance pathways and cognition.Trial registration ClinicalTrials.gov NCT05602220. Registered on January 12, 2023. (Source: Trials)
Source: Trials - March 15, 2024 Category: Research Source Type: clinical trials

Mean Arterial Pressure (MAP) Trial: study protocol for a multicentre, randomized, controlled trial to compare three different strategies of mean arterial pressure management during cardiopulmonary bypass
We described herein the methodology of a multicentre, randomized, controlled trial comparing three different approaches to MAP management during CPB in patients undergoing elective cardiac surgery: the historically accepted “standard MAP” (50–60 mmHg), the “high MAP” (70–80 mmHg) and the “patient-tailored MAP” (comparable to the patient’s preoperative MAP). It is the aim of the study to find the most suitable management in order to obtain the most adequate perfusion of end-organs during cardiac surger y. For this purpose, the primary endpoint will be the peak of serum lactate (Lmax) released during CPB, a...
Source: Trials - March 15, 2024 Category: Research Source Type: clinical trials

Correction: Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)
(Source: Trials)
Source: Trials - March 15, 2024 Category: Research Source Type: clinical trials

Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): study protocol for a five-arm, cluster-randomized trial
Globally, 144 million children under 5 years are undernourished and 250 million do not meet their developmental potential. Multi-input interventions, such as bundled nutrition and parenting interventions, are ... (Source: Trials)
Source: Trials - March 14, 2024 Category: General Medicine Tags: Study protocol Source Type: research

Trials that turn from retrospectively registered to prospectively registered: a cohort study of “retroactively prospective” clinical trial registration using history data
Prospective registration of clinical trials is mandated by various regulations. However, clinical trial registries like ClinicalTrials.gov allow registry entries to be updated at any time, and key study elemen... (Source: Trials)
Source: Trials - March 14, 2024 Category: General Medicine Authors: Martin Holst and Benjamin Gregory Carlisle Tags: Research Source Type: research

Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): study protocol for a five-arm, cluster-randomized trial
DiscussionEFFECTS will generate evidence on the effects of bundled nutrition and parenting interventions on child nutrition, growth, and development outcomes; determine the benefits of engaging fathers on child, caregiving, and caregiver outcomes; and investigate common and unique pathways between treatments and child outcomes.Trial registrationClinicalTrials.gov NCT03759821. Registered on November 30, 2018 (Source: Trials)
Source: Trials - March 14, 2024 Category: Research Source Type: clinical trials

Trials that turn from retrospectively registered to prospectively registered: a cohort study of “retroactively prospective” clinical trial registration using history data
ConclusionsRetroactively prospective trial registration happens in one in 50 trials. While these changes to the start date could be mistakes or legitimate edits based on the most up-to-date information, they could also indicate a retrospectively registered trial that has been made to appear as a prospectively registered trial, which would lead to biases unapparent to reviewers. Our results point to the need for more transparent reporting of changes to a trial ’s details and have implications for the review and conduct of clinical trials, with our fully automated and freely available tools allowing reviewers or editors to...
Source: Trials - March 14, 2024 Category: Research Source Type: clinical trials

Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial
Traumatic brain injury (TBI) is a leading cause of disability in children. Cognitive rehabilitation for this population is critical for their long-term health outcomes. This trial aims to evaluate the efficacy... (Source: Trials)
Source: Trials - March 13, 2024 Category: General Medicine Authors: Jiabin Shen, Yan Wang, Susan Quinn, Stacy J. Suskauer, Julia Birch, Tyler Busch, Adrian Svingos, Roger Crawfis, Keith Owen Yeates and H. Gerry Taylor Tags: Study protocol Source Type: research

Correction: Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial
(Source: Trials)
Source: Trials - March 13, 2024 Category: General Medicine Authors: Nick Birk, Laura L. Oakley, Poppy A. C. Mallinson, Deepa R, Giridhara R. Babu, Mofat Nyirenda and Sanjay Kinra Tags: Correction Source Type: research

The clinical effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: results from a multicenter, pragmatic randomized controlled trial
Persistent depressive disorder (PDD) is prevalent and debilitating. For patients with PDD, psychiatric rehabilitation using self-management interventions is advised as the next therapeutic step after multiple ... (Source: Trials)
Source: Trials - March 13, 2024 Category: General Medicine Authors: Ericka C. Solis, Ingrid V. E. Carlier, No ëlle G. A. Kamminga, Erik J. Giltay and Albert M. van Hemert Tags: Research Source Type: research