Efficacy of silymarin in patients with non-alcoholic fatty liver disease — the Siliver trial: a study protocol for a randomized controlled clinical trial
This study has been approved by the Research Ethics Committee of the Professor Edgard Santos University Hospital Complex, Salvador BA, Brazil, under protocol 2.635.954. The study is carried out according to guidelines and regulatory standards for research involving humans, as set out in Brazilian legislation. Trial registration - ClinicalTrials.gov : NCT03749070. November 21, 2018 (Source: Trials)
Source: Trials - March 10, 2023 Category: Research Source Type: clinical trials

Barriers and facilitators to the recruitment of disabled people to clinical trials: a scoping review
ConclusionsBoth barriers and facilitators were often highly specific to disability type and context. Assumptions should be minimised, and study design should prioritise principles of co-design and be informed by a data-driven assessment of needs for the study population. Person-centred approaches to consent that empower disabled people to exercise their right to choose should be adopted in inclusive practice. Implementing these recommendations stands to improve inclusive practices in clinical trial research, serving to produce a well-rounded and comprehensive evidence base. (Source: Trials)
Source: Trials - March 8, 2023 Category: Research Source Type: clinical trials

Effects of an 8-week multimodal exercise program on ground reaction forces and plantar pressure during walking in boys with autism spectrum disorder
ConclusionsOur results suggest that a joyful and multimodal exercise program has positive effects on kinetic walking characteristics of autism spectrum disorder boys. Accordingly, we recommend to implement this type of exercise in prepubertal autism spectrum disorder boys to improve gait kinetics.Trial registrationIranian Registry of Clinical Trials IRCT20170806035517N4. Registered on November 8, 2021. This study was approved by the Ethical Committee of the University of Mohaghegh Ardabili, Ardabil, Iran (IR.UMA.REC.1400.019). The study was conducted in accordance with the latest version of the Declaration of Helsinki. (Source: Trials)
Source: Trials - March 8, 2023 Category: Research Source Type: clinical trials

Creating a best practice template for participant communication plans in global health clinical studies
ConclusionThe use of communication plans in global health clinical trials is lacking. To our knowledge, this is the first in-depth analysis of communication plans in clinical trials to date. We recommend that researchers utilize the developed communication plan template throughout the entire research process to ensure a human-centered approach to participant communication. This communication plan should apply to all phases of a research trial, with a particular emphasis on plans to share results in an accessible and engaging manner once the trial has been completed. (Source: Trials)
Source: Trials - March 2, 2023 Category: Research Source Type: clinical trials

The efficacy of nalmefene on anesthetic recovery of patients: a study protocol for a multicenter randomized controlled trial
AbstractIntroductionSo far, the recovery quality after general anesthesia is still unsatisfied. Nalmefene is a drug to treat opioid overdose and reverse opioid actions. We aim to investigate the efficacy of nalmefene on optimizing the recovery quality of patients after general anesthesia.MethodsIt is a prospective, placebo-controlled, two-arm parallel groups, multicentre, double-blind, randomized (PPPMDR) clinical trial. The participants (n = 520) will be randomly assigned into two groups. Each patient will receive either: a single dose of nalmefene 0.25 µg/kg in the intervention group, or the same volume of 0.9% NaC...
Source: Trials - March 1, 2023 Category: Research Source Type: clinical trials

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action
ConclusionCollaboration across disciplines, sectors, organisations, and countries is essential if the ethical and methodological challenges surrounding trials involving complex and alternate consent pathways are to be addressed. Explicating these challenges, sharing resources, and identifying gaps for future research is an essential first step. We hope that doing so will serve as a call to action for others seeking ways to address the current consent-based exclusion of underserved populations from trials. (Source: Trials)
Source: Trials - February 28, 2023 Category: Research Source Type: clinical trials

Is sling immobilization necessary after open Latarjet surgery for anterior shoulder instability? A randomized control trial
This study is a single-center, randomized control trial. Sixty-eight patients will be instructed with the same standardized immediate postoperative self-rehabilitation protocol. Patients will be allocated 1:1 between a sling immobilization group for the first three postoperative weeks and no sling group without postoperative immobilization. The primary endpoint will be functional outcome at 6  months postoperative evaluated by the disease-specific Rowe score. Secondary endpoints will include baseline, 1.5-, 6-, and 12-month single assessment numeric evaluation (SANE) of instability score and visual analog pain scale (VAS)...
Source: Trials - February 27, 2023 Category: Research Source Type: clinical trials

Modified ultrasound scalpel haemorrhoidectomy versus conventional haemorrhoidectomy for mixed haemorrhoids: a study protocol for a single-blind randomised controlled trial
DiscussionThe study was approved by the ethics committee. The first patient was registered on July 1 2021. The purpose of this trial will be to evaluate the clinical efficacy and safety of the modified ultrasonic scalpel haemorrhoidectomy procedure for the treatment of mixed haemorrhoids and to provide an evidence base for the clinical promotion and application of the procedure. A limitation of this study is that only the patients will be single-blinded because the researchers and the patients cannot be blinded at the same time, which may produce certain bias in the results. In addition, the sample size of this study will ...
Source: Trials - February 24, 2023 Category: Research Source Type: clinical trials