Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial —statistical analysis plan for a multicenter randomized controlled trial
DiscussionThe findings of this trial will provide evidence for future clinical guidelines on optimal cord clamping management at birth.Trial registrationClinicalTrials.gov NCT03808051. Registered on 17 January 2019. (Source: Trials)
Source: Trials - March 4, 2024 Category: Research Source Type: clinical trials
Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators
ConclusionsRecording harms or adverse events in behaviour change intervention trials is complex and challenging; multi-disciplinary experts in trial design and implementation welcome forthcoming guidance on this topic. Issues include the high burden of recording irrelevant harms and use of definitions originally designed for drug trials. Proportionate recording of harms focused on events with a strong plausible link to the intervention and multi-disciplinary team input into decision making are essential. (Source: Trials)
Source: Trials - March 4, 2024 Category: Research Source Type: clinical trials
A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment or mild Alzheimer ’s disease dementia (ROMEMA): study protocol of a double-blind, randomized, placebo-controlled, between-subjects trial
DiscussionThe outcomes of the present study aim to elucidate the significance of the PDE4 inhibition mechanism as a prospective therapeutic target for enhancing cognitive function in individuals with (a)MCI and mild AD dementia. Identifying positive effects within these patient cohorts could extend the relevance of this treatment to encompass a broader spectrum of neurological disorders.Trial registrationThe Medical Ethics Committee of MUMC + granted ethics approval for the 4th version of the protocol on September 10th, 2020. The trial was registered at the European Drug Regulatory Affairs Clinical Trials (EudraCT) re...
Source: Trials - March 4, 2024 Category: Research Source Type: clinical trials
Evaluation of a financial incentive intervention on malaria prevalence among the residents in Lake Victoria basin, Kenya: study protocol for a cluster-randomized controlled trial
This study will aim to develop a demand-side policy tool to encourage local residents ’ active malaria prevention and early treatment-seeking behaviors. We examine the causal impact of a financial incentive intervention complemented with malaria education to residents in malaria-prone areas. A cluster-randomized controlled trial is designed to assess the effect of the financial inc entive intervention on reducing malaria prevalence in residents of Suba South in Homa Bay County, Kenya. The intervention includes two components. The first component is the introduction of a financial incentive scheme tied to negative RDT res...
Source: Trials - March 4, 2024 Category: Research Source Type: clinical trials
Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial
DiscussionThis randomized clinical trial is expected to verify the hypothesis that postoperative prolonged sedation with DEX after successful reperfusion may promote the long-term prognosis of patients with AIS and may reduce the related socio-economic burden.Trial registrationClinicalTrials.gov NCT04916197. Prospectively registered on 7 June 2021. (Source: Trials)
Source: Trials - March 4, 2024 Category: Research Source Type: clinical trials
A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment or mild Alzheimer ’s disease dementia (ROMEMA): study protocol of a double-blind, randomized, placebo-controlled, between-subjects trial
Research into the neurobiological underpinnings of learning and memory has demonstrated the cognitive-enhancing effects associated with diverse classes of phosphodiesterase (PDE) inhibitors. Specific PDE inhib... (Source: Trials)
Source: Trials - March 4, 2024 Category: General Medicine Authors: Nina Possemis, Frans Verhey, Jos Prickaerts, Arjan Blokland and Inez Ramakers Tags: Study protocol Source Type: research
Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators
Harms, also known as adverse events (AEs), are recorded and monitored in randomised controlled trials (RCTs) to ensure participants ’ safety. Harms are recorded poorly or inconsistently in RCTs of Behaviour Cha... (Source: Trials)
Source: Trials - March 4, 2024 Category: General Medicine Authors: Diana Papaioannou, Kirsty Sprange, Sienna Hamer-Kiwacz, Cara Mooney, Gwenllian Moody and Cindy Cooper Tags: Research Source Type: research
Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10 –17-year-olds presenting at police custody: a randomised controlled trial
Within England, children and young people (CYP) who come into police custody are referred to Liaison and Diversion (L&D) teams. L&D teams have responsibility for liaising with healthcare and other support serv... (Source: Trials)
Source: Trials - March 2, 2024 Category: General Medicine Authors: Gwenllian Moody, Elinor Coulman, Emma Crocker-White, Kylie Gray, Richard P. Hastings, Andrea Longman, Fiona Lugg-Widger, Rebecca Playle, Jeremy Segrott, Paul Thompson, Julia Badger, Peter E. Langdon and Samantha Flynn Tags: Study protocol Source Type: research
Coenzyme Q10 supplementation in burn patients: a double-blind placebo-controlled randomized clinical trial
Burn injuries are important medical problems that, aside from skin damage, cause a systemic response including inflammation, oxidative stress, endocrine disorders, immune response, and hypermetabolic and catab... (Source: Trials)
Source: Trials - March 2, 2024 Category: General Medicine Authors: Zahra Kiani, Nadereh Khorsand, Fahimeh Beigi, Gholamreza Askari, Manoj Sharma and Mohammad Bagherniya Tags: Research Source Type: research
Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials
(Source: Trials)
Source: Trials - March 2, 2024 Category: General Medicine Authors: Jonathan A. Cook and Richard A. Parker Tags: Letter Source Type: research
Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10 –17-year-olds presenting at police custody: a randomised controlled trial
DiscussionThis two-arm individually RCT will evaluate the effectiveness of SFBT in reducing offending behaviours in CYP presenting at police custody suites within the area served by LSCFT. Our process evaluation will assess the fidelity of delivery of SFBT, the factors affecting implementation, the acceptability of SFBT in CYP aged 10 –17 years and recruitment and reach. We will also examine systems and structures for future delivery, therefore assessing overall scalability.Trial registrationClinicalTrials.gov ISRCTN14195235. Registered on June 16, 2023. (Source: Trials)
Source: Trials - March 2, 2024 Category: Research Source Type: clinical trials
Coenzyme Q10 supplementation in burn patients: a double-blind placebo-controlled randomized clinical trial
ConclusionResults showed that in patients with burn injury, CoQ10 administration had no effect on inflammatory markers and oxidative stress, although serum albumin levels were improved after supplementation. Further studies with albumin as the primary outcome are needed to confirm this finding. (Source: Trials)
Source: Trials - March 2, 2024 Category: Research Source Type: clinical trials
Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials
(Source: Trials)
Source: Trials - March 2, 2024 Category: Research Source Type: clinical trials
Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients
Outcome assessment in perioperative exercise trials for lung cancer is heterogeneous, often omitting those that are important and patient-relevant. This heterogeneity hinders the synthesis of evidence. To addr... (Source: Trials)
Source: Trials - March 1, 2024 Category: General Medicine Authors: Wanjun Zhou, Yawen Zhang, Zhiwei Wang, Liang Zhang and Xinqiong Zhang Tags: Study protocol Source Type: research
Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial
Emerging adulthood is often associated with mental health problems. About one in three university students report symptoms of depression and anxiety that can negatively affect their developmental trajectory co... (Source: Trials)
Source: Trials - March 1, 2024 Category: General Medicine Authors: Anne H. Berman, Naira Topooco, Petra Lindfors, Marcus Bendtsen, Philip Lindner, Olof Molander, Martin Kraepelien, Christopher Sundstr öm, Nooshin Talebizadeh, Karin Engström, George Vlaescu, Gerhard Andersson and Claes Andersson Tags: Study protocol Source Type: research
