Trials Journal
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Trials is an open access peer-reviewed medical journal covering performance and outcomes of randomized controlled trials. The journal is published by BioMed Central; the editors-in-chief are Jeremy Grimshaw (Ottawa Health Research Institute), Peter Jüni (University of Toronto), Tianjing Li (Johns Hopkins Bloomberg School of Public Health), and Shaun Treweek (University of Aberdeen). It also publishes study protocols. Source
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| Scope | National |
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| Language | English |
| Country | United Kingdom |
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Recent Articles
Search ArticlesInternet of Things-based pulsed electromagnetic field combined with exercise therapy in patients with knee osteoarthritis: randomized, controlled, noninferiority trial protocol | Trials | Full Text
The primary objective is to compare the therapeutic effects of IOT-BPEMFE and OT in patients with KOA, providing evidence to inform the selection of optimal community-based exercise delivery mode. The primary hypothesis is that IOT-BPEMFE will achieve pain and functional outcomes that are noninferior to those achieved with OT.
Estimating treatment effect in randomised controlled trials with continuous outcomes subject to non-compliance: a logistic regression-based multiple imputation approach | Trials | Full Text
The CACE has been one of the most commonly applied statistical methods for handling non-compliance in RCTs [27]. Owing to its flexibility, CACE has been applied to various types of study designs and outcomes, including longitudinal studies with time-dependent non-compliance [28], and RCTs with univariate binary response [29], among others. In this paper, we propose a novel CACE-based method, LMI, to estimate treatment effects on continuous outcomes when there is substantial non-compliance.
Mental health first aid training to improve depression literacy among health ambassadors in Iran: study protocol for a cluster-randomized controlled trial | Trials | Full Text
The data will be collected in two stages, preintervention (T0) and postintervention at the end of the second month (T2), using the Depression Literacy Questionnaire (2014) [53]. This questionnaire consists of two parts: depression literacy and demographic characteristics: This section of the questionnaire pertains to the assessment of depression literacy and comprises 34 questions.
Ivabradine for prevention of myocardial injury after noncardiac surgery (PREVENT-MINS trial): study protocol for a randomized controlled trial - Trials
Study personnel follow patients throughout their time in the hospital before and after surgery and evaluate their clinical status and medical records, documenting all outcomes. Troponins are measured before surgery and on postoperative days 1, 2, and 3. An ECG is obtained whenever an elevated troponin is detected, as per routine practice. A heart ultrasound and/or cardiologist consultation is ordered as needed based on the investigator’s decision.
Extended mesenteric resection in Crohn’s disease: EXCEED Study Protocol—a blinded multicenter randomized controlled clinical trial (RCT) - Trials
Crohn’s disease, marked by chronic gastrointestinal inflammation, presents challenges regarding management and due to recurrence of the disease. This study delves into the preventive potential of extended mesenteric excision in ileocecal resection to reduce disease recurrence in Crohn’s patients.
Correction: Development of a core outcome set for paediatric upper limb spasticity; a structured review protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey | Trials | Full Text
Correction: Development of a core outcome set for paediatric upper limb spasticity; a structured review protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey Correction Open access Published: 20 November 2025 Trials volume 26, Article number: 527 (2025) Cite this article The Original Article was published on 10 November 2025 Correction: Trials 26, 485 (2022) https://doi.org/10.1186/s13063-025-09141-w Following the publication of the...
Comparison of 90-90 ball and balloon exercise versus Kegel’s exercise on pelvic floor muscle strength and quality of life among postpartum women with stress urinary incontinence-a randomized clinical trial protocol | Trials | Full Text
Department of Physiotherapy and Department of Gynecology and Obstetrics, Srinivas Medical College Hospital, Mangalore, India. See Table 1. Not applicable, the study does not use any biological specimens or provisions for additional data. The comparators used in the study were chosen based on the study design, research question, and to match the objectives of the study. Control group (group A): Knack technique and Kegel’s exercises.
Correction: Elucidating treatment targets and mediators within a confirmatory efficacy trial: study protocol for a randomized controlled trial of cognitive-behavioral therapy vs. light therapy for winter depression | Trials | Full Text
Correction: Elucidating treatment targets and mediators within a confirmatory efficacy trial: study protocol for a randomized controlled trial of cognitive-behavioral therapy vs.
Supplemental choline to prevent and treat learning and memory deficits of early-life iron deficiency (The SupCHO Study): study protocol for a randomized, placebo-controlled trial in Ugandan infants with iron deficiency anemia | Trials | Full Text
Primary outcome: Elicited Imitation outcomes (number of steps correctly recalled and number of steps recalled in the correct order for both immediate and delayed recall) at age 15 months, i.e., after 9 months of daily supplementation with choline or placebo. For each of these outcomes, we will compare groups using a one-way analysis of covariance (ANCOVA).
The effect of Trehalose on inflammatory markers, oxidative stress, clinical symptoms, and mortality in patients with head trauma in Iran: a double-blind, placebo-controlled, randomized clinical trial protocol | Trials | Full Text
Our study will be conducted at Al-Zahra Hospital, a large public, university-affiliated referral center for TBI in Isfahan, Iran.