Trials试验
Trials(英文缩写 TRIALS),ISSN 1745-6215,eISSN 1745-6215,中文译名:试验 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-09-28 至 2026-09-28，按本站收录文献的发表日期统计。
期刊介绍
Trials 最新收录文献
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1. Children's participation in assent to paediatric oncology research: experiences of children, siblings and parents.
PMID:日期:2026-09-21Research is essential for improving outcomes in paediatric oncology, yet decisions about research participation often occur during emotionally vulnerable periods for families. Although children's assent is ethically required, it is not always meaningfully implemented in practice. Understanding how children, siblings and parents experience the child's involvement in the assent process, including their attitudes towards research, is crucial for promoting ethically sound research and supporting genuine child participation. The aim of this study was to describe how children with cancer, siblings and parents experience the child's assent process during research recruitment in paediatric oncology, with particular attention to its motivational and relational dimensions. A descriptive qualitative study design. Interviews were undertaken with children with cancer (n = 11), siblings (n = 17) and parents (n = 9) regarding their experiences of recruitment to various types of research in Sweden. Data was analysed using reflexive thematic analysis. Two main themes were identified: a moral and emotional commitment to research, and relational assent-trust, loyalty and parental mediation. Children, siblings and parents described research participation as meaningful and morally significant in a vulnerable situation. Children's involvement in assent ranged from active participation to limited influence, with some decisions made primarily by parents. Decisions about research participation were shaped by relational dynamics, in which trust, loyalty, and emotional vulnerability and parental mediation played central roles. Families are strongly motivated to contribute to research in paediatric oncology. However, sustaining trust and safeguarding research integrity require consistent and meaningful implementation of children's assent. Child-centred, flexible, and context-sensitive assent processes are key, alongside ethical awareness of how relational dynamics shape children's autonomy. Recognising parents as key partners is essential for upholding both ethical standards and children's rights in paediatric research.
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2. Beyond antibiotic duration in acute cholangitis: system-level determinants after biliary drainage.
PMID:日期:2026-09-16The COBRA trial addresses whether antibiotic exposure can be safely reduced after adequate biliary drainage in acute cholangitis. We argue that antibiotic duration should be interpreted within the broader care pathway in which treatment is delivered, because source control, device management, host susceptibility, local microbiological ecology, and reliability of care processes may modify clinical outcomes. Drawing on the Medical Research Council framework for complex interventions, we propose a system-level interpretation that complements, rather than replaces, the randomized comparison of antibiotic duration. A 24-month single-center quasi-experimental study in a gastroenterology unit, recently accepted for publication, provides hypothesis-generating support for this perspective: implementation of a standardized and traceable work-support intervention was associated with reductions in healthcare-associated infections, ward microbial pressure, and clinically expressed microbial burden. These findings do not establish causality or determine optimal antibiotic duration in acute cholangitis. To make care-pathway variability more explicit in future studies, we propose a Bundle Deviation Score based on six domains: timely diagnosis, timing of biliary drainage, adequacy of drainage and source control, antimicrobial strategy, device management, and standardized high-contact care. This contextual process measure could complement patient-centered outcome frameworks such as Desirability of Outcome Ranking by distinguishing treatment effects from variability in how care is delivered. The COBRA trial provides important evidence for antimicrobial stewardship after biliary drainage. Its interpretation and transferability may be strengthened by measuring the reliability of the broader care pathway alongside antibiotic duration. Prospective validation is required before the proposed Bundle Deviation Score can be used for clinical or research applications.
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3. Study protocol for a multicenter prospective randomized-controlled trial to test a systematic remote and app-based prehabilitation program in comparison to education-only before major surgery: the LUMOS Study.
PMID:日期:2026-09-10Recent studies have demonstrated significant benefits associated with prehabilitation prior to major surgery. However, digital solutions in this domain are currently lacking. Our previous study, the Protego Maxima trial, reported positively assessed usability, validity, and safety of a prehabilitation application. In this randomized-controlled multicenter study, we aim to ascertain whether a digital prehabilitation program can reduce perioperative morbidity and costs in patients undergoing major surgery. The LUMOS trial is a multicenter prospective randomized-controlled trial comparing a 3-to-6-week interventional digital prehabilitation program with a digitized informational app, against a control group receiving only the informational application. The trial seeks to enroll 382 participants who will be block-randomized based on diagnosis into either the intervention or control group. The primary endpoint is the reduction of 90-day morbidity from 60 to 45% (Dindo-Clavien I-V). Secondary objectives include the 1-year overall survival, quality of life, length of hospital stay (including ICU, IMC, and general ward), readmission rates, compliance, and program adherence, product malfunction, vigilance reporting, improvement of the 6-min walking test by at least 20%, and hospital cost assessment. The LUMOS trial aims to evaluate the effectiveness of a digital prehabilitation program compared to an informational app only, prior to major surgery. The objective is to demonstrate the significant value of a digitized remote prehabilitation program in reducing perioperative morbidity, as well as addressing cost considerations. Trial registered in the European Database on Medical Devices (EUDAMED) (CIV-24-02-046162) and German Clinical Trial Registry (DRKS00033612, 13.05.2024), DMIDS-Number: 00015083, https://drks.de/search/en/trial/DRKS00033612 . Goethe University Frankfurt: 024-1681-MDR/MPDG-zuständig multizentrisch, 06.05.2024.
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4. PrEgabalin for Treatment Resistant generalised Anxiety disorder (PETRA): study protocol for a double-blind randomised controlled trial set in the UK.
PMID:日期:2026-09-03Generalised anxiety disorder (GAD) is common and increasingly recognised in primary care. Although antidepressants and psychological therapies are first-line treatments, many patients have residual anxiety and limited access to therapy. Evidence for effective next-step pharmacological options for treatment resistant anxiety remains limited. This paper describes the protocol for the PETRA trial, which will evaluate the clinical and cost-effectiveness of adding pregabalin to antidepressant treatment, compared with placebo, for people with GAD who have not responded or partially responded to antidepressant treatment. PETRA is a multicentre, individually randomised, double-blind, placebo-controlled superiority trial conducted in UK primary care. Participants are recruited by the study team from approximately 150 General Practices and randomised in a 1:1 ratio, using minimisation, to either pregabalin or a matching placebo for 26 weeks (followed by a tapering period where their dosage is reduced over approximately 4 weeks). Sample size is 498. Eligible participants are adults aged 18-74 years, who have been taking antidepressant medication for at least 8 weeks, received treatment with at least one other antidepressant before their current antidepressant and meet ICD-11 criteria for GAD and score ≥ 12 on the revised clinical interview schedule (CIS-R) total score. Follow-up assessments are at 3, 6, 12, 26 and ~ 30 weeks. Our primary outcome measure will be anxiety symptoms measured with GAD-7 at 12 weeks (continuous score). Secondary outcomes are anxiety (GAD-7) at other time points, depressive and panic symptoms, suicidal thoughts, self-rated global improvement, adherence to study medication, serious adverse events, adverse effects, alcohol consumption and benzodiazepine use, quality of life and resources and costs used. The ~ 30-week assessment will investigate symptoms during the withdrawal from pregabalin. Exploratory analyses will include cognitive tasks. A cost-effectiveness analysis and a nested qualitative study will evaluate the implementation and intervention acceptability. The trial findings will inform primary care prescribing practice by providing an accurate and generalisable estimate of the clinical and cost-effectiveness of prescribing pregabalin to individuals with generalised anxiety who have not responded or only partially responded to antidepressant treatment. Controlled Trials ISRCTN Registry, ISRCTN 16993990, registered on 19/09/2023. First participant enrolled in January 2024.
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5. Efficacy and cost-effectiveness of Internet-delivered cognitive-behavior therapy for children and adolescents with body dysmorphic disorder: study protocol for a randomized controlled trial.
PMID:日期:2026-08-31Body dysmorphic disorder (BDD) is a prevalent and impairing mental disorder that typically onsets in adolescence. Cognitive-behavior therapy (CBT) may be effective for adolescent BDD, although the supporting evidence is currently limited. CBT for BDD is a highly specialized treatment, creating a considerable gap in access to care for young people. Therapist-guided Internet-delivered CBT (ICBT) may help bridge this gap. The primary aim of this study is to determine the efficacy of a therapist-guided ICBT program for children and adolescents with BDD versus an active comparator. Secondary aims are to examine the 6-month durability of the treatment effects and to evaluate its relative cost-effectiveness from multiple perspectives. This is a 3-site superiority randomized controlled trial including 154 young people (12-17 years) with BDD recruited throughout Sweden. Participants are randomized 1:1 to 12 weekly modules of either therapist-supported ICBT primarily based on exposure with response prevention or an active comparator consisting of therapist-supported Internet-delivered relaxation training. Data will be collected at baseline, mid-treatment, post-treatment, and 1 month (primary endpoint), 3 months, and 6 months post-treatment. The primary outcome is BDD symptom severity measured with the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version. All study personnel who can be blinded to study aims/hypotheses and group allocation will be blinded. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blinded to study aims/hypotheses and group allocation at all assessment points. Analyses will be conducted according to the intention-to-treat principle and will follow a pre-specified statistical and health economic analysis plan. Participant recruitment started on 22 February 2024 and is currently ongoing. Data analysis for the primary aim will commence after the last participant reaches the primary endpoint. ClinicalTrials.gov NCT06262412. Registered on 16 February 2024, https://clinicaltrials.gov/study/NCT06262412 .
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6. The effects of norepinephrine infusion combined with goal-directed fluid therapy on delayed graft function in patients undergoing kidney transplantations: study protocol for a multicenter randomized controlled trial.
PMID:日期:2026-08-29Chronic kidney disease presents a formidable challenge to global healthcare systems. With ongoing advancements in surgical techniques, kidney transplantation has emerged as a principal therapeutic modality for individuals afflicted with end-stage renal disease, markedly enhancing their long-term prognosis and overall quality of life postoperatively. Nevertheless, the occurrence of delayed graft function represents a prevalent early complication following kidney transplantations, mainly stemming from the ischemia-reperfusion injury incurred by the transplanted kidneys and the utilization of extended criteria donor organs. The manifestation of delayed graft function can precipitate primary allograft nonfunction, acute rejection episodes, and potentially fatal outcomes. Vigilant attention to perioperative fluid management emerges as a cornerstone in mitigating the risk of delayed graft function. Recent strides in Goal-directed fluid therapy have garnered substantial attention within critical care contexts, with empirical evidence underscoring its favorable impact on postoperative outcomes in critically ill cohorts. However, the efficacy of Goal-directed fluid therapy specifically in the context of kidney transplantation remains a subject of ongoing debate and scrutiny. Hence, the imperative arises to investigate potential strategies aimed at attenuating the incidence of delayed graft function in this patient demographic. A multicenter, randomized, single-blind, two-arm parallel-group, controlled trial will be undertaken to assess the efficacy of norepinephrine in conjunction with Goal-directed fluid therapy on graft function recovery among individuals slated for kidney transplantations. Patients will be allocated randomly to either a control or intervention arm, wherein conventional fluid management or the administration of norepinephrine infusion combined with Goal-directed fluid therapy will be administered, respectively. The primary objective of this study is to investigate the potential efficacy of norepinephrine infusion in conjunction with goal-directed fluid therapy in mitigating the occurrence of delayed graft function among individuals undergoing kidney transplantations. The findings of this investigation have the potential to advance the field of perioperative care in kidney transplantations by providing insights into optimized management strategies. ClinicalTrials.gov NCT06367205. Registered on April 16, 2024.
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7. Process evaluation of the randomized trial-"Care management for older people with cognitive impairment during and after hospitalisation in Germany (intersec-CM)".
PMID:日期:2026-08-29Effective care of people with cognitive impairment and their families depends, among other things, on the cooperation of the professionals involved in their care. An effective dementia care management support model for people with dementia and their families for the outpatient sector has been further developed for ambulatory and hospital settings. The intersec-CM randomized controlled trial (RCT) implemented this intersectoral care management (iCM) model into routine care in three hospitals in Bielefeld and Greifswald (Germany). Care managers (CMs) trained in advance for the study used a computer-based information management system (IMS) to assess patients' health and care needs and to develop individualized care plans. The iCM aimed to improve hospital-to-primary-care transitions and ensure cross-sectoral care. This was accompanied by a process evaluation to complement the data collected in the RCT. The aim was to understand how the complex intervention works in the selected real-world setting. This paper presents the results of this process evaluation. For the process evaluation, a mixed-method design was chosen and applied. The evaluation was based on the guidelines of the British Medical Research Council for the implementation and process evaluation of complex interventions (MRC framework). A method triangulation was conducted consisting of several successive phases (t1: qualitative, t2: quantitative, t3: qualitative). The sample (t1: individual interviews n = 30, t2: survey n = 177, t3: individual interviews n = 33) consisted of patients and their relatives, clinical physicians, social workers, carers, general practitioners, care managers (CMs), and project management. The process evaluation showed that intersectoral iCM could be implemented in the hospitals. The CMs were partially successful in assessing needs, developing individual treatment plans, and coordinating and monitoring the needs of people with cognitive impairment and their families. They found it difficult to work with the different actors in the healthcare system because of the rigid daily routines and lack of time in the clinics. Overall, the results show that (1) people with cognitive impairment and their families can benefit from the intervention and (2) iCM can help with the flow of information between health professionals. The present process evaluation underlines the necessity and meaningfulness of process evaluations to understand the functionality and procedural feasibility of an RCT. Through the study, significant insights into the "black box" of the implementation of the iCM intervention could be gained. ClinicalTrials.gov NCT03359408. The trial was registered on December 2, 2017.
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8. Metacognitive Training for Negative Symptoms (MCT-Minus) in schizophrenia: study protocol for a pragmatic randomized controlled trial.
PMID:日期:2026-08-28Negative symptoms are experienced by up to 60% of the individuals with schizophrenia and represent a stronger indicator of current and future functioning than positive symptoms. These symptoms respond poorly to pharmacological and existing psychosocial interventions, highlighting the need for targeted treatments. Previous research suggests that defeatist performance beliefs, combined with metacognitive deficits, may contribute to negative symptoms. A recent pilot study, adapting the cognitive intervention metacognitive training (MCT) to address negative symptoms, found symptom reduction, primarily due to improved reflective functioning and reduced perceived stigma. The current study aims to further assess the efficacy of this intervention and to explore potential mechanisms of change in negative symptoms. Ninety participants aged 18 and older with a psychotic disorder will be recruited from psychiatric care settings in Sweden. Participants will be randomly assigned to either the intervention group (MCT-Minus) or a control group receiving supportive counselling (SC). Data will be collected at baseline, post-intervention, and at 12-week and 12-month follow-ups. Magnetic resonance imaging (MRI) will be performed at baseline and post-intervention. Exit interviews will be held after completing the intervention. The primary outcome is change in negative symptom, measured by the Clinical Assessment Interview for Negative Symptoms (CAINS), across all time points. Repeated measures ANCOVA will be used to evaluate primary outcomes. Additional analyses will address changes in positive symptoms and potential mechanisms of change, including metacognition and internalized stigma. Qualitative data from exit interviews will be analyzed using reflexive thematic analysis. This study is designed to evaluate the efficacy of MCT-Minus compared to supportive counselling. Given the limited treatment options for negative symptoms in schizophrenia, the findings may have important clinical implications. This study was registered on the 6th of November 2023 on Clinical Trials with the trial registration number NCT06127004. Statistical analyses will be preregistered on the Open Science Framework.
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9. Efficacy and safety of SP16 in preventing acute kidney injury in at-risk subjects with chronic kidney disease undergoing elective cardiac surgery using the heart-lung-machine (EASE-AKI): study protocol for a prospective, randomised, double-blind, placebo-controlled clinical trial.
PMID:日期:2026-08-28Cardiac surgery using cardiopulmonary bypass uses controlled hypoperfusion which leads to relative organ damage. Acute kidney injury is the most frequent and most important organ failure, in particular in patients with chronic kidney disease. To date, there are no approved drug treatments that could effectively prevent acute kidney injury. SP16, an agonist of the low-density lipoprotein receptor-related protein 1, has been shown to exert both kidney- and cardioprotective effects in preclinical trials. Early clinical use of SP16 in phase I trials was safe. Administration of SP16 had beneficial trends on inflammatory response and infarct size in patients with ST-segment elevation myocardial infarction. The primary objective of this phase IIa trial is to demonstrate that injection of SP16 is safe and superior to placebo in preventing cardiac surgery-associated acute kidney injury within 7 days after surgery. This randomised, double-blinded, placebo-controlled, single-centre study evaluates the efficacy and safety of SP16 in 120 high-risk chronic kidney disease patients with disease stage G2-G3b undergoing cardiac surgery who are randomised into one of two treatment groups in a 1:1 ratio: SP16 (12 mg) or placebo. The study medication is administered via two subcutaneous injections, with the first dose given before surgery, followed by an additional dose after 9 h. Primary endpoints are the incidence of acute kidney injury during 7 days post-surgery and the frequency of adverse events within 72 h after index surgery. Important secondary endpoints include the incidence of major adverse kidney events at day 90 and impact on cardiac function. Safety assessments encompass adverse events, vital signs, electrocardiograms and routine safety laboratory tests. Additional evaluations include pharmacokinetics and immunological biomarkers. This single-centre phase IIa trial will assess the incidence of cardiac surgery-associated acute kidney injury, describing the kidney-protective potential of SP16 and its safety profile in patients undergoing cardiac surgery. EUCT, EUCT number 2025-522491-89-00. Registered on February 2, 2026, https://euclinicaltrials.eu/ctis-public/view/2025-522491-89-00 . Patient recruitment is planned to start on August 1, 2026.
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10. Interim analysis in clinical trials: caution against premature conclusions-the SWOG multiple myeloma S0777 case study.
PMID:日期:2026-08-27Interim monitoring for efficacy and futility provides critical decision-making boundaries on early termination of randomized clinical trials. Such analyses can accelerate access to effective therapies and limit exposure to ineffective ones, but this must be weighed against premature closure that can risk obscuring a true treatment benefit. We discuss these considerations and present a case study highlighting the importance of following a well-designed interim analysis plan. SWOG Cancer Research Network (SWOG) S0777 was a randomized phase III study of bortezomib, lenalidomide, and dexamethasone (VRd) versus Rd in newly diagnosed multiple myeloma that incorporated two pre-planned interim analyses. At both interim analyses, while the futility stopping boundaries were not crossed, the accumulating data suggested a limited or diminishing benefit in progression-free survival (PFS). In contrast, at final analysis, VRd demonstrated significant improvement in both PFS (hazard ratio (HR) = 0.71, p = 0.0018) and overall survival (HR = 0.71, p = 0.025) compared to Rd, helping establish VRd as standard of care. Retrospective analysis shows that use of common alternative futility stopping rules would have also not been crossed, despite the lack of positive results at the interim analysis. S0777's success underscores the importance of pre-specified interim monitoring plans and cautions against premature trial termination.