The clinical rollout of a novel intervention for Veterans with persistent post-concussive symptoms: Protocol for a pragmatic 2-site trial of On-TRACC [0.03%]
针对持续性脑震荡症状的老兵开展一项新型干预措施的临床推广：On-TRACC 实用性两中心试验方案
Kathleen F Pagulayan,Holly K Rau,Rishika Das et al.
Kathleen F Pagulayan et al.
Background and objectives: Veterans with a history of mild traumatic brain injury (mTBI) often report persistent post-concussive symptoms (PPCS). Clinical care guidelines recommend psychoeducation as well as assessment an...
Andrea Bastek,Amanda Zenere,Heather Manley et al.
Andrea Bastek et al.
Background: The clinical trials industry faces a growing capacity gap driven by an increasing number of studies combined with site and staff shortages. The Site Enablement League (SEL) Task Force on Frontier Sites was est...
A Bayesian model with seasonal effects for predicting accrual in clinical trials: Application to HOBIT and BOOST-3 trials for severe traumatic brain injury [0.03%]
一种带有季节效应的贝叶斯模型可预测临床试验的入组情况：重型颅脑损伤患者的HOBIT和BOOST-3试验的应用
Mohammod Mahmudur Rahman,Md Saiful Islam Saif,Jonathan Beall et al.
Mohammod Mahmudur Rahman et al.
Background: Accurate accrual prediction is essential for initial planning and ongoing monitoring of clinical trials. Slow accrual can compromise statistical power, increase costs, or lead to premature trial termination. T...
Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease [0.03%]
VICTRIVA研究的设计与合理性：vedolizumab联合upadacitinib治疗克罗恩病的III期双盲随机试验
Silvio Danese,Bruce E Sands,Brian G Feagan et al.
Silvio Danese et al.
Introduction: Remission rates in patients with Crohn's disease (CD) suggest a therapeutic ceiling with one advanced targeted treatment, representing an unmet need. Dual targeted therapy may provide a more effective treatm...
Evaluating continuous identity cognitive therapy for veterans with a recent suicidal episode: An open-label group pilot study [0.03%]
评估连续身份认知疗法对近期有自杀行为的老兵的效果：一项开放性小组试点研究
Yosef Sokol,Sofie Glatt,Sarah Andrusier et al.
Yosef Sokol et al.
Introduction: There is a gap in effective recovery-oriented treatments for Veterans experiencing suicidal thoughts and/or behaviors, particularly those recovering from a suicidal episode. This study aimed to evaluate the ...
The Bud App: A protocol for a randomized controlled trial with an internal pilot phase targeting modifiable risk and protective factors for suicide among international students [0.03%]
Bud应用程序：一项针对国际学生自杀危险和保护因素的随机对照试验的协议（含内部试点阶段）
Samuel McKay,Christina Ng,Jennifer Nicholas et al.
Samuel McKay et al.
International students face elevated risk for mental health problems and suicide, yet encounter multiple barriers to accessing timely and culturally responsive treatments. Key challenges include high rates of psychological distress, low men...
Yogurt reintroduction and the circulating microbiome in healthy volunteers: protocol for a prospective, longitudinal, species-controlled crossover clinical trial (MAMI) [0.03%]
一项关于健康志愿者的酸奶再引入与循环微生物组关系的研究：前瞻性纵向菌种控制交叉临床试验（母乳喂养婴儿微生物群研究）方案
Junhong Su,Bettina E Hansen,Zifang Wang et al.
Junhong Su et al.
Background: Although the gut microbiome plays a crucial role for maintaining overall host homeostasis and metabolism, it is significantly influenced by dietary changes, leading to substantial temporal variations in microb...
The REST (randomised evaluation of sleeping with a toy or comfort item) trial: a protocol for an online, randomised trial of comfort item use on sleep quality in children [0.03%]
关于儿童使用安慰物对睡眠质量影响的线上随机试验REST（晚上陪伴玩具或安慰物入睡的随机评估）试验：研究方案
Simone Lepage,Laura Flight,Nikki Totton et al.
Simone Lepage et al.
Randomised controlled trials (RCTs) are the gold standard for evaluating healthcare interventions. Participatory research, in which the public is engaged in research activities, enhances their understanding of trials but requires innovative...
Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3 [0.03%]
监管指南更新对当代单纯性尿路感染临床试验结果的影响及对未来试验设计和药物开发的启示：EAGLE-2与EAGLE-3研究对比分析
Florian Wagenlehner,Keith S Kaye,David A Talan et al.
Florian Wagenlehner et al.
Aim: To understand the impact of current regulatory guidance for non-inferiority, randomized controlled trials (RCTs) in uncomplicated urinary tract infection (uUTI) on efficacy outcomes. ...
A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults [0.03%]
成人颞下颌关节紊乱病痛激光光生物调节治疗的随机对照试验方案
Selenia Rubio,Patricia Cabrera,Rory Reever et al.
Selenia Rubio et al.
Evidence-based treatments for painful temporomandibular disorders (TMD) are lacking. The most common treatments for painful TMDs, intraoral appliances and pain medication, provide suboptimal pain control, often leading to treatment-limiting...