Trials最新文献

{"title":"Antisecretory factor as add-on treatment for newly diagnosed glioblastoma, IDH wildtype: study protocol for a randomized double-blind placebo-controlled trial.","authors":"Erik Ehinger, Anna Darabi, Edward Visse, Charlotte Edvardsson, Gregor Tomasevic, David Cederberg, Sara Kinhult, Anna Rydelius, Christer Nilsson, Mattias Belting, Johan Bengzon, Peter Siesjö","doi":"10.1186/s13063-025-08792-z","DOIUrl":"10.1186/s13063-025-08792-z","url":null,"abstract":"<p><strong>Background: </strong>Glioblastoma, IDH wildtype is the most common primary malignant brain tumor in adults. Despite best available treatment, prognosis remains poor. Current standard therapy consists of surgical tumor removal followed by radiotherapy and chemotherapy with the alkylating agent temozolomide. Antisecretory factor (AF), an endogenous protein, may potentiate the effect of temozolomide and alleviate cerebral edema. Salovum® is an egg-yolk powder enriched for AF and is classified as a medical food in the European Union. Salovum® has shown preliminary clinical effect on glioblastoma in a recent pilot study. Here, we aim to assess if add-on Salovum® to temozolomide therapy can improve outcomes in patients with newly diagnosed glioblastoma.</p><p><strong>Methods: </strong>This is a multi-center, double-blinded, randomized, placebo-controlled phase II-III clinical trial to investigate superiority of Salovum® over placebo as add-on treatment for glioblastoma during concomitant and adjuvant temozolomide therapy. Patients with newly diagnosed glioblastoma that are planned for temozolomide treatment are screened for eligibility and randomized to receive Salovum® (n = 150) or placebo (n = 150). An interim analysis will be performed after 80 included patients to guide whether to continue or terminate. Primary endpoint is 12-month overall survival. Secondary outcome is 24-month overall survival.</p><p><strong>Discussion: </strong>This study will likely produce high-grade evidence to support or reject Salovum® as add-on treatment for glioblastoma.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05669820 . Registered on January 3, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"86"},"PeriodicalIF":2.0,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11905463/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626067","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Mentalization for Offending Adult Males (MOAM): study protocol for a randomized controlled trial to evaluate mentalization-based treatment for antisocial personality disorder in male offenders on community probation.","authors":"Peter Fonagy, Jessica Yakeley, Tessa Gardner, Elizabeth Simes, Mary McMurran, Paul Moran, Mike Crawford, Alison Frater, Barbara Barrett, Angus Cameron, James Wason, Stephen Pilling, Stephen Butler, Anthony Bateman","doi":"10.1186/s13063-025-08729-6","DOIUrl":"10.1186/s13063-025-08729-6","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"87"},"PeriodicalIF":2.0,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907891/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626074","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of platelet-rich plasma as an adjunct therapy to split thickness skin graft in burn patients with granulating raw wounds: a prospective, randomized, double-blind study-study protocol.","authors":"Susmita Behera, Biswajit Mishra, Jerin Jose Cherian, Gunjan Kumar, Smita Mahapatra, Aparna Mukherjee, Sudipto Roy, Bhavani Shankara Bagepally, Binay Bhusan Sahoo, Madan Mohan Majhi, S ShoganRaj, Vijay Kumar, Arindam Sarkar, P Nellaiappar","doi":"10.1186/s13063-025-08757-2","DOIUrl":"10.1186/s13063-025-08757-2","url":null,"abstract":"<p><strong>Background: </strong>Burn wounds are commonly encountered in clinical settings and the management aims at the prevention of mortality and morbidity due to disability. The platelet-rich plasma (PRP) is blood-derived biomaterial that is enriched with growth factors and cytokines that facilitate wound healing. The PRP has proven its efficacy in various other wounds, but its role in post-burn raw areas and graft take has not been validated. This proposed multicentre randomized controlled trial aims to evaluate the efficacy and safety of platelet-rich plasma as an adjunct therapy to split-thickness skin graft in burn patients with granulating raw wounds.</p><p><strong>Method/design: </strong>This trial is an investigator-initiated, double-blind multicentre, randomized controlled parallel arm trial alongside trial cost-effectiveness analysis. Granulating deep second-degree and third-degree burns affecting 3-20% of total body surface area (TBSA) at 10-14th post-burn day will be included in the study. A total of 550 patients (275 in each group) will be randomized to receive either standard skin graft or allogenic PRP with skin graft treatment. The primary endpoint will be the mean percentage of graft-take on the 14th postoperative day. The result will be analyzed by two independent assessors who are blinded to the study. Secondary endpoints include (a) time taken for complete wound healing; (b) frequency of adverse events; (c) follow-up with scar index at 3 months, 6 months, and 1 year using the Patient and Observer Scar Assessment Scale (POSAS) score; (d) cost-effectiveness analysis of the intervention compared to the comparator; and (e) to estimate in a subset of participants the association between growth factor levels (PDGF BB and TGF ß-1) of activated PRP and clinical response.</p><p><strong>Discussion: </strong>The proposed trial will be expected to verify the efficacy and safety of PRP for split-thickness skin graft (STSG) in deep second-degree or third-degree granulating wounds of burn patients based on the outcome of the study.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"83"},"PeriodicalIF":2.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11900483/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Participant and trial characteristics reported in predictive analyses of trial attrition: an umbrella review of systematic reviews of randomised controlled trials across multiple conditions.","authors":"Ryan McChrystal, Jennifer Lees, Katie Gillies, David McAllister, Peter Hanlon","doi":"10.1186/s13063-025-08794-x","DOIUrl":"10.1186/s13063-025-08794-x","url":null,"abstract":"<p><strong>Background: </strong>Trial attrition poses several risks for the validity of randomised controlled trials (RCTs). To better understand attrition, studies have explored and identified predictors among participant and trial characteristics. Reviews of these have so far been limited to single conditions. We performed an umbrella review to explore which participant and trial characteristics are reported in predictive analyses of trial attrition in systematic reviews of RCTs across multiple conditions.</p><p><strong>Methods: </strong>We searched MEDLINE, Embase, Web of Science and the Online Resource for Research in Clinical TriAls for systematic reviews of RCTs that evaluated associations between participant/trial characteristics and attrition. We included quantitative systematic reviews of adult populations that evaluated any participant/trial characteristic and any attrition outcome. Review quality was appraised using R-AMSTAR. A review-level narrative synthesis was conducted.</p><p><strong>Results: </strong>We identified 88 reviews of RCTs evaluating characteristics associated with attrition. Included reviews encompassed 33 different conditions. Over half (50/88, 56.8%) were of RCTs for psychological conditions. All but one examined trial characteristics (87/88, 98.9%) and fewer than half (42/88, 47.7%) evaluated participant characteristics. Reviews typically reported on participant age (33/42, 78.6%), sex (29/42, 69.1%) and the type (13/42, 31%) or severity (10/42, 23.8%) of an index condition. Trial characteristics typically reported on were intervention type (56/87, 64.4%), intervention frequency/intensity (29/87, 33.3%), intervention delivery/format (26/87, 29.9%), trial duration (16/87, 18.4%), publication/reporting year (15/87, 17.2%) and sample size (15/87, 31.9%). Retention strategies were rarely reported (2/87, 2.3%). No characteristic was examined for every condition. Some reviews of certain conditions found that age (12/33, 36.4%), intervention type (29/56, 51.8%) and trial duration (9/16, 56.3%) were associated with attrition, but no characteristic was reportedly associated across multiple conditions.</p><p><strong>Conclusions: </strong>Across conditions, reviews conducting predictive analyses of attrition in RCTs typically report on several characteristics. These are participant age, sex and the type or severity of index condition, as well as the type, frequency or intensity and delivery or format of a trial intervention, trial duration, publication/reporting year and sample size. Future studies should consider exploring these characteristics as a core set when evaluating predictive factors of attrition in RCTs across multiple conditions.</p><p><strong>Registration: </strong>PROSPERO CRD42023398276.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"84"},"PeriodicalIF":2.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11900635/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Scientific review of protocols to enhance informativeness of global health clinical trials.","authors":"B Burford, T Norman, S Dolley","doi":"10.1186/s13063-025-08763-4","DOIUrl":"10.1186/s13063-025-08763-4","url":null,"abstract":"<p><strong>Background: </strong>Trial informativeness describes the likelihood of a clinical trial to have a meaningful impact on clinical practice, research, or policy decisions. A dedicated scientific review process for protocols at the post-funding stage is not common, yet is an opportunity to enhance trial informativeness. The Bill and Melinda Gates Foundation (BMGF), one of the largest funders of clinical trials, created a group called Design, Analyze, Communicate (DAC). DAC's first completion of an expert scientific review of a grantee's trial protocol was in 2020. We categorized and quantified areas of scientific review feedback provided for 52 clinical trial protocols submitted to DAC over a 3-year period. Most trials planned to study treatment interventions and included at least one trial site in a low- and middle-income country. Feedback themes offer insight into areas of trial design weakness.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of protocol review feedback provided by DAC to grantees. Reviews were completed by BMGF between 2020 and 2022. A qualitative content analysis was conducted by developing a codebook of clinical trial methodology topics and subtopics and systematically coding free-text review feedback. Manual text classification of individual feedback statements enabled quantification and frequency analysis of review feedback.</p><p><strong>Results: </strong>A total of 1537 individual recommendations were made across all 52 protocols. The median number of recommendations per protocol was 28 (range: 13 to 52), covering a wide range of issues related to clinical trial design, implementation, analysis, and impact. Nearly half of all recommendations (47%) were characterized by the review team as high priority. The areas with the highest frequency of recommendations were statistics and data analysis, trial procedures, and intervention/dose.</p><p><strong>Conclusions: </strong>This study provides a taxonomy of scientific review feedback topic areas that can be used to categorize clinical trial design topics. The high number of recommendations per protocol review across several distinct topic areas highlights the need for a scientific review to enhance trial informativeness. This review must take place prior to trial initiation and review teams should include statistical and trial design expertise with additional expertise tailored to the trial/intervention type and phase.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"85"},"PeriodicalIF":2.0,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11899556/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143617457","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA).","authors":"Jaideep C Menon, Denny John, Aswathy Sreedevi, Chandrasekhar Janakiram, Akshaya R, Sumithra S, Aravind M S, Mathews Numpeli, Bipin Gopal, Renjini B A, Sajeev P K, Ravivarman Lakshmanasamy, Abhishek Kunwar","doi":"10.1186/s13063-025-08789-8","DOIUrl":"10.1186/s13063-025-08789-8","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"82"},"PeriodicalIF":2.0,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895169/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606365","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of combining a proximal strengthening exercise program and foot orthosis on pain and performance among women with patellofemoral pain syndrome and a pronated foot: study protocol for a randomized clinical trial.","authors":"Mansoureh Barati Ashtiani, Hassan Daneshmandi, Zahra Raeisi","doi":"10.1186/s13063-025-08787-w","DOIUrl":"10.1186/s13063-025-08787-w","url":null,"abstract":"<p><strong>Backgrounds: </strong>Patellofemoral pain syndrome (PFPS) is one of the most frequent musculoskeletal disorders. Flatfoot and weakness of the hip and core muscles have been introduced as distal and proximal factors associated with this syndrome, respectively. The aim of this study is to investigate the effectiveness of a combination of a proximal strengthening exercise (PSE) program and a foot orthosis (PSEFO) on pain and function in women with PFPS and a pronated foot (PF).</p><p><strong>Methods: </strong>In this randomized clinical trial (RCT), 117 female patients aged 18-40 years will be recruited through online announcements on cyberspace as well as those installed in rehabilitation and healthcare centers and gyms. Considering the inclusion criteria, the participants will be randomized into three groups of 39 (group I: practicing PSEs and wearing PSEFO; group II: practicing only PSEs; and group III: control group [CG]). Randomization will be conducted using the sequentially numbered, opaque, sealed envelope (SNOSE) technique. The intervention groups (groups I and II) will perform PSEs at gyms for 2 months at the rate of three sessions per week (each session lasting 45-60 min) under the guidance of a trainer. In addition to the PSE, group I participants will receive prefabricated polyurethane FOs with an 8° varus wedge. They will be asked to wear the orthosis for 2 h a day and then slowly increase their wearing time to a full day. The CG participants will follow their routine lives during this study. Pain, as the primary outcome, will be measured by the visual analog scale before and after the 8-week intervention program. Additionally, quality of life, disability, Q angle, performance, and dynamic balance will be evaluated as secondary outcomes using the 36-item Short Form Health Survey, the Kujala score, a goniometer, the step-down test, the unilateral squat test, the anteromedial lunge test, the bilateral squat test, and the Y-balance test, respectively.</p><p><strong>Discussion: </strong>In this RCT, the effectiveness of PSEs focusing on the hip and core muscles, with and without FOs, on pain and performance among women with PFPS and PF will be investigated and compared.</p><p><strong>Trial registration: </strong>The present study was approved by the Research Ethics Committee of Guilan University of Medical Sciences, Rasht, Iran (code: IR.GUILAN.REC.1402.021) and registered on the Iranian Registry of Clinical Trials (IRCT, code: IRCT20230604058380N1) at 28 July 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"81"},"PeriodicalIF":2.0,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11895253/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143597911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Polysomnographic titration of non-invasive ventilation in motor neurone disease (3TLA): protocol for a process evaluation of a clinical trial.","authors":"Marnie Graco, David J Berlowitz, Abbey Sawyer, Anne E Holland, Kate A Carey, Yasmin Ahamed, Anna Ridgers, Natasha A Lannin","doi":"10.1186/s13063-025-08784-z","DOIUrl":"10.1186/s13063-025-08784-z","url":null,"abstract":"<p><strong>Background: </strong>We are undertaking a multicentre randomised controlled trial to determine the effectiveness of including a sleep study (polysomnography (PSG)) to assist the commencement of non-invasive ventilation (NIV) in people with motor neurone disease (MND): the Polysomnographic titration of non-invasive ventilation in motor neurone disease (PSG4NIVinMND; 3-three letter acronym; 3TLA) trial. A process evaluation will be conducted alongside the clinical trial to understand: (1) the implementation of the 3TLA intervention in the trial sites, including barriers and enablers, and (2) the mechanisms through which the 3TLA intervention produces change. This protocol paper describes the rationale, aims and methods of the 3TLA process evaluation.</p><p><strong>Methods: </strong>To guide the design of the process evaluation, a logic model representing the 3TLA intervention, the likely mechanisms of impact, potential external contextual factors and assumptions, and the anticipated outcomes was developed by the researchers in collaboration with the 3TLA Trial Steering Committee. From this, five key process evaluation research questions were identified, a priori. The mixed-methods design is guided by three implementation frameworks: the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, the Theoretical Domains Framework (TDF), and the Theoretical Framework of Acceptability (TFA). We will conduct semi-structured interviews with approximately 20-30 clinical trial participants (people with MND) and their carers, and focus groups and surveys with approximately 60 health professionals involved in delivering the intervention at each site. Quantitative process data will also be collected from the main clinical trial. Qualitative and quantitative data will be analysed iteratively throughout the trial, independent of the main trial outcome analyses. Process evaluation findings will be triangulated with the results of the clinical trial.</p><p><strong>Discussion: </strong>This process evaluation incorporates a mixed-methods design and is informed by three theoretical frameworks. It will provide insights into how the 3TLA intervention was implemented, for whom and how the 3TLA intervention was (and was not) effective, and what adaptations may be needed to facilitate future implementation into routine clinical practice.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05136222. Registered on November 25, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"79"},"PeriodicalIF":2.0,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11884123/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143574224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of group-based nutritional education combined with individual standard care for outpatients with type 2 diabetes: study protocol for a randomized clinical trial {1}.","authors":"Aline Busanello, Vanessa Machado Menezes, Olivia Garbin Koller, Ândria Völz Andreia, Jussara Carnevale de Almeida","doi":"10.1186/s13063-025-08720-1","DOIUrl":"10.1186/s13063-025-08720-1","url":null,"abstract":"<p><strong>Background: </strong>Diabetes remains a significant contributor to global morbidity and mortality in the twenty-first century. Lifestyle modification strategies are widely recommended for effective diabetes management. Research suggests that a person-centered approach, implemented in either group or individual settings, offers considerable potential for improving long-term disease outcomes. Nutritional counseling using the operative group model has been tested and shown to yield positive health outcomes across diverse populations affected by diabetes. This study aims to evaluate the impact of group-based nutritional education, combined with individual standard care, compared to individual standard care alone, on health outcomes among patients diagnosed with type 2 diabetes.</p><p><strong>Methods: </strong>This study is a 12-month, parallel-group, randomized superiority controlled trial. Individuals diagnosed with type 2 diabetes will be randomized in a 1:1 ratio into one of two treatment arms: (1) individual usual care alone or (2) usual care supplemented with group-based nutritional education. The group nutritional education will consist of three sessions addressing the following themes: \"Let's Go Shopping,\" \"Healthy Plate,\" and \"Hunger and Satiety.\" The primary outcome will be the change in HbA1c levels. Secondary outcomes will include fasting glucose, lipid profile, body mass, dinapenic abdominal obesity, blood pressure, eating behavior, adherence to nutritional counseling, and diabetes-related complications. All outcomes will be assessed at baseline and at 4, 8, and 12 months, except diabetes-related complications that will be assessed at baseline and 12 months. Sample size calculations were based on an estimated mean difference of 0.59 ± 1.39% in HbA1c with the intervention (patient-centered group), using a type I error rate of 5% and a type II error rate of 20%. It was determined that 88 participants per group (1:1 randomization; n = 176) would provide sufficient statistical power. Accounting for an anticipated dropout rate of 30%, a total of 252 participants will be recruited to ensure the necessary sample size is maintained throughout the study period.</p><p><strong>Discussion: </strong>The American Diabetes Association recommends interventions for patients with diabetes lasting more than 10 h over a period of 6 to 12 months to optimize health outcomes. Therefore, this study hypothesizes that integrating group-based nutritional education into standard treatment within a nutrition-specialized outpatient clinic may lead to further improvements in health parameters among individuals diagnosed with type 2 diabetes mellitus. TRIAL REGISTRATION {2A AND 2B}: Clinicaltrials.gov identifier, NCT05598203. Registered on 13 October 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"78"},"PeriodicalIF":2.0,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11884081/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143574204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience.","authors":"Sergio Buccheri, Stefan James, Marion Mafham, Martin Landray, Tom Melvin, Jonas Oldgren, Richard Bulbulia, Louise Bowman, Lotje Anna Hoogervorst, Perla J Marang-van de Mheen, Peter Juni, Peter McCulloch, Alan G Fraser","doi":"10.1186/s13063-025-08783-0","DOIUrl":"10.1186/s13063-025-08783-0","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"80"},"PeriodicalIF":2.0,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883905/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143574198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}