- Enhancing reach and effectiveness of recruitment through email: a study within a trial (SWAT). [Journal Article]Trials. 2026 Aug 06; 27(1).T
- CONCLUSIONS: Veterans who received an email subject line with an institutional reference to the VA were more likely to open the email and enroll in a clinical trial than veterans who received an incentive or altruistic subject line. This study did not detect clear evidence of a substantial benefit for recruitment to sending prenotification emails.
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- Reporting of justifications for withholding established effective interventions in randomised placebo-controlled trials: a systematic review. [Systematic Review]Trials. 2026 Aug 01; 27(1).T
- CONCLUSIONS: In this sample of protocols published in Trials in 2022, 10% withheld an established effective intervention without a reported justification, and this mostly related to withholding effective concomitant medications from both study arms. The majority of studies do not make their participant facing material available and so it cannot be determined what information is provided to study participants.
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- Effect of coffee bean chlorogenic acid on peripheral skin temperature and skin blood flow in healthy Japanese women with cold sensitivity: a placebo-controlled, randomized, double-blind, study. [Randomized Controlled Trial]Trials. 2026 Aug 06; 27(1).T
- CONCLUSIONS: These results suggest that the ingestion of coffee bean CGA can suppress the decrease in SkT and SkBF in a cold environment.
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- Effectiveness of virtual reality exposure therapy in improving body dissatisfaction and shape-related concerns in adolescent girls with anorexia nervosa: a controlled, randomized, superiority trial. [Randomized Controlled Trial]Trials. 2026 Aug 06; 27(1).T
- CONCLUSIONS: The study hypothesizes that VRET is more effective than a body-first psychomotricity approach in improving BD-SRC and that this improvement is stable in the long term, even after treatment has stopped. If this hypothesis is confirmed, VRET could offer an interesting new therapeutic alternative to the traditional European approach of body-first psychomotricity for adolescent girls with AN.
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- INTENSIFY-a randomized, controlled trial to investigate the effect of an early intensified pharmacological treatment for major psychiatric disorders after treatment failure in the current episode: a study protocol. [Journal Article]
- CONCLUSIONS: Should the current study show clinical evidence that the use of third-line treatment is efficacious and safe earlier to treat severe mental illness, the results could impact treatment guidelines in due course. In addition, the study will contribute to the identification of clinical, digital and blood-based markers that are associated with treatment response to early and intensified treatments.
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- STABILOOP, a cohort trial to assess automated insulin delivery in the management of patients living with type 1 diabetes who are eligible for islet transplantation. [Multicenter Study]
- CONCLUSIONS: This first study of AID in patients eligible for islet transplantation includes clinical, psychosocial, and economic outcomes. Its strengths are the comprehensive evaluation and real-world design. Findings will support evidence-based guidance for treating severe glycemic instability in T1D.
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- Efficacy of a training program to support the application of the Guideline Evidence-based Health Information: a randomized controlled trial and process evaluation. [Randomized Controlled Trial]
- CONCLUSIONS: We did not achieve the targeted sample size of 26 providers. A lack of resources was one of the main barriers to recruitment. Although our study did not provide conclusive evidence regarding the primary outcome, the participants rated the training program as relevant. Therefore, the training program will be made available to health information providers upon request.
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- Teacher-delivered transdiagnostic child mental healthcare in rural Indian primary schools (Tealeaf): study protocol for a batched stepped-wedge cluster randomized controlled trial with a hybrid effectiveness-implementation-context design. [Journal Article]
- CONCLUSIONS: This study will generate rigorous evidence on the effectiveness of teacher-delivered, transdiagnostic mental health care in under-resourced school settings, while elucidating how implementation processes and context shape real-world impact.
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- Transdiagnostic metacognitive therapy compared to disorder-specific cognitive behavioral therapy for anxiety disorders: a study protocol for a randomized controlled superiority trial. [Journal Article]
- CONCLUSIONS: Considering the potential of MCT, further research is needed to evaluate its effectiveness compared to CBT, particularly MCT in a transdiagnostic format. Results from this trial will add to the evidence base for tMCT and inform treatment development, decision-making and implementation of effective treatment for anxiety disorders in routine care.
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- The cardiac intervention imaging clinical trial of an intracardiac ultrasound catheter and ultrasound system: the multicenter, randomized, INTELICE trial protocol. [Journal Article]
- CONCLUSIONS: The INTELICE trial will provide high-quality comparative evidence on ICE image performance and procedural safety between a novel ICE catheter system and an established commercial device. In addition, this study aims to establish standardized criteria for ICE image quality assessment and to explore differences between operator-based and sonographer-based evaluations, which may improve the consistency and reliability of ICE-guided cardiac interventions.
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- Lanreotide for the prevention of postoperative pancreatic fistula (S2408): study protocol for a multicenter randomized controlled trial. [Journal Article]
- CONCLUSIONS: S2408 is a multicenter clinical trial designed to evaluate the hypothesis that a single dose of preoperative lanreotide will reduce the incidence of POPF in patients undergoing DP compared to placebo.
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- Effects of mechanical thrombectomy combined with anticoagulation vs anticoagulation monotherapy for acute intermediate-high risk pulmonary embolism: study protocol for a randomized controlled trial (CAPE study, ChiCTR2500095253, https://www.medicalresearch.org.cn/clinicalResearch/researchInfo?id=c57630b7-51ec-4b24-83e1-85b9c0a835d6). [Journal Article]
- CONCLUSIONS: CAPE is a RCT to compare the short and long efficacy of MT combined with anticoagulation and anticoagulation monotherapy for acute intermediate-high pulmonary embolism. The result will give more evidence for selection of different strategies for physicians.
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- PROMISE: a PROspective randomised double-blind parallel group placebo-controlled multicentre trial of faecal MIcrobiota tranSplantation to improve outcomEs in patients with cirrhosis over 24 months-study protocol for a clinical trial. [Journal Article]
- CONCLUSIONS: The PROMISE study will assess the efficacy and evaluate the mechanisms of action of FMT in patients with ALD, MASLD and MetALD cirrhosis. FMT may provide an alternative non-antibiotic treatment for these patients through ecological reconstitution of microbial balance.
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- Remote vs. In-Person Study Evaluation (RISE) Trial 1 of 3 to examine the impact of decentralized trial methods on accrual efficiency, retention, biospecimen capture, and treatment utilization: study protocol for a multi-center randomized controlled trial in the context of smoking cessation (RISE Above Smoking). [Journal Article]
- CONCLUSIONS: The RISE RCTs will provide novel, rigorous evidence regarding the impact of remote trial methods on trial efficiency and rigor, including the degree to which these effects generalize across clinical contexts and participant characteristics.
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- Low cost app-based intervention DIALOG+ for anxiety and depression in outpatient psychiatric settings: a pragmatic multisite cluster randomized controlled trial. [Journal Article]
- CONCLUSIONS: If feasible, acceptable, and effective, DIALOG+ for clinically diagnosed persons with anxiety and depressive disorders could represent a transformative, scalable solution for improving mental health outcomes in India and similar LMIC contexts.
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