Trials最新文献

{"title":"A multi-center, open-label, randomized clinical trial evaluating the preventive effect of perampanel on craniotomy-induced epileptogenesis in seizure-naive patients with supratentorial brain tumors: study protocol for a GRAMPAS trial.","authors":"Junya Yamaguchi, Fumiharu Ohka, Kazuya Motomura, Tomotaka Ishizaki, Norimoto Nakahara, Shigeru Fujitani, Tetsuya Nagatani, Masasuke Ohno, Masahiko Ando, Yachiyo Kuwatsuka, Kazuki Nishida, Ryuta Saito","doi":"10.1186/s13063-024-08693-7","DOIUrl":"https://doi.org/10.1186/s13063-024-08693-7","url":null,"abstract":"<p><strong>Background: </strong>Early seizures after craniotomy are significant perioperative complications that can adversely impact patient outcomes. Despite current guidelines advising against the routine use of antiseizure drugs for seizure after craniotomy prevention due to limited efficacy data, many clinicians continue prescribing them. This discrepancy highlights the need for robust evidence to guide clinical practice. This multi-center, randomized clinical trial was designed to investigate the efficacy of perampanel in preventing early seizures after craniotomy.</p><p><strong>Method: </strong>This multi-center, open-label, randomized clinical trial will be conducted across five hospitals in Nagoya, Japan, from February 2024 to December 2026. A total of 142 seizure-naive patients with supratentorial brain tumors will be recruited and randomized (1:1) into the treatment and control groups. The treatment group will receive 2 mg of perampanel starting 2 days preoperatively and continuing for 28 days postoperatively, while the control group will receive no antiseizure drugs. The primary outcome is the incidence of seizures within 28 days after craniotomy. Secondary outcomes are length of hospital and intensive care unit stays and postoperative complications.</p><p><strong>Discussion: </strong>This study addresses the critical need for evidence-based recommendations regarding antiseizure drug use for preventing early seizures after craniotomy. As the first multi-center, randomized trial evaluating perampanel's efficacy in this setting, the findings may significantly influence clinical guidelines and perioperative practices.</p><p><strong>Trial registration: </strong>This trial was registered with the Japan Registry of Clinical Trials (approval number: jRCTs041230117) on December 18, 2023, a member of the Primary Registry Network of the World Health Organization's International Clinical Trials Registry Platform.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"849"},"PeriodicalIF":2.0,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Application of indocyanine green-human serum albumin complex in fluorescence image-guided laparoscopic anatomical liver resection: study protocol for a randomized controlled trial.","authors":"Qingyun Xie, Fengwei Gao, Xiaoyun Ran, Xin Zhao, Manyu Yang, Kangyi Jiang, Tianyang Mao, Jiayin Yang, Kun Li, Hong Wu","doi":"10.1186/s13063-024-08695-5","DOIUrl":"https://doi.org/10.1186/s13063-024-08695-5","url":null,"abstract":"<p><strong>Background: </strong>Indocyanine green (ICG) is a near-infrared fluorescent dye widely used for intraoperative navigation during liver surgeries because of its non-radioactive nature, high safety, and minimal impact on liver function. However, variability in its dosage and concentration and its low imaging success rates have limited its widespread application. To address these issues, we developed a novel ICG-human serum albumin (ICG-HSA) complex to enhance fluorescence visualization during laparoscopic anatomical liver resection.</p><p><strong>Methods: </strong>This prospective, double-blind, single-center, randomized controlled trial will compare the fluorescence navigation effects of the novel ICG-HSA complex with the guideline-recommended ICG administration scheme. The study will involve patients aged 18 to 75 years with malignant liver tumors. The participants will undergo evaluations at specified time points, and data will be collected using an internet-based electronic data capture system. The primary outcome will be the effectiveness of intraoperative fluorescence imaging, assessed by three independent experts. The secondary outcomes will be conversion to open surgery, the total operative time, intraoperative blood loss, and long-term survival rates.</p><p><strong>Discussion: </strong>The aim of using this novel ICG-HSA complex will be to improve the success rate of fluorescence navigation in liver resection by ensuring better stability and a longer liver retention time compared with free ICG. This study seeks to validate the clinical value of ICG-HSA in enhancing surgical precision and outcomes, ultimately promoting its broader clinical application. The results are expected to provide high-level evidence supporting the safety and efficacy of this new fluorescence imaging agent.</p><p><strong>Trial registration: </strong>ClinicalTrial.gov NCT06219096. Registered on 1 December 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"847"},"PeriodicalIF":2.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of Sarcomeal® oral supplementation plus vitamin D3 on muscle parameters and metabolic factors in diabetic sarcopenia patients: study protocol of a randomized controlled clinical trial.","authors":"Ramin Abdi Dezfouli, Narges Zargar Balajam, Sara Shirazi, Ramin Heshmat, Gita Shafiee","doi":"10.1186/s13063-024-08700-x","DOIUrl":"https://doi.org/10.1186/s13063-024-08700-x","url":null,"abstract":"<p><strong>Background: </strong>Diabetes is a significant risk factor for sarcopenia, a muscle dystrophy affecting older individuals. Sarcopenia management typically involves resistance exercise and oral supplements. Given the limitations of resistance training for many elderly individuals, oral supplements play a crucial role in treatment. This study is a protocol for evaluating the efficacy of the Sarcomeal® supplement, a mixture of whey protein, creatine, branch-chained amino acids (BCAAs), glutamine, and hydroxyl-methyl-butyrate (HMB) in diabetic people who also have sarcopenia. METHODS AND ANALYSIS: This study is a randomized clinical trial, in which sixty diabetic sarcopenia patients who meet the inclusion criteria will be randomly assigned to the control or the intervention group with a 1:1 allocation. The intervention group will receive one Sarcomeal® supplement sachet plus 1000 IU of vitamin D daily and both groups will be recommended to consume protein-rich food, be educated about the disease, and perform light exercises for 12 weeks. Anthropometric measurements, body composition analysis, muscle strength assessments, and blood tests will be conducted at the trial's start and end.</p><p><strong>Discussion: </strong>It is hypothesized that the Sarcomeal® supplement plus vitamin D may be beneficial for the management of diabetic sarcopenia by reducing inflammation, oxidative stress, and glucose metabolism. The outcome of this trial will provide a basis for prescribing sarcomeal to patients with diabetic sarcopenia.</p><p><strong>Ethics and dissemination: </strong>This protocol is registered at the Iranian Registry of Clinical Trials (IRCT20230831059311N1) and also is approved by the ethics committee of Tehran University of Medical Sciences (September 2023, IR.TUMS.EMRI.REC.1402.071).</p><p><strong>Trial registration: </strong>Iranian Registry of Clinical Trials (ID: IRCT20230831059311N1).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"848"},"PeriodicalIF":2.0,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142883058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation of a parent training intervention (SPARCK) to prevent childhood mental health problems: study protocol for a pragmatic implementation trial in Norwegian municipalities.","authors":"Anette Arnesen Grønlie, Agathe Backer-Grøndahl, Ragnhild Bang Nes, Maria Begoña Gomez, Truls Tømmerås","doi":"10.1186/s13063-024-08704-7","DOIUrl":"https://doi.org/10.1186/s13063-024-08704-7","url":null,"abstract":"<p><strong>Background: </strong>Effective evidence-based interventions (EBI) are necessary to prevent and avoid negative life trajectories for children with mental health problems. Even though many EBIs prove effective when tested, few are successfully implemented and used in real-world clinical practice. As a result, many children and families do not receive the best care in due time or at all. To reduce this research-practice gap, a combined RCT and implementation study of Supportive Parents-Coping Kids (SPARCK), a parent training intervention to prevent childhood mental health problems, will be performed. This study protocol concerns the implementation part of the larger effectiveness-implementation project.</p><p><strong>Methods: </strong>The study is a correlational multi-site implementation study of SPARCK performed alongside a two-armed RCT, in 24 Norwegian municipalities. A quantitative three-wave longitudinal web-based data collection will be conducted among SPARCK practitioners and leaders in relevant services. We will investigate the relations between theory-driven and empirical implementation determinants and implementation outcomes, measured by fidelity, acceptability, appropriateness, and feasibility. In addition, we will examine how these implementation determinants and outcomes are associated with the clinical outcomes of SPARCK.</p><p><strong>Discussion: </strong>The current study will investigate implementation determinants and their relation to indicators of implementation success, while simultaneously investigating effectiveness of an intervention optimized to the needs of both the target group and relevant stakeholders. Together, this may improve clinical effect, contextual fit, implementation success, and reduce the time lag between research findings and application in real-world settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05800522. Registered on 2023.03.23.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"846"},"PeriodicalIF":2.0,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872867","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors associated with male recruitment in a multi-site randomized behavioral clinical trial targeting the metabolic syndrome: analysis of screening and recruitment data from the ELM trial.","authors":"Chen Yeh, Melissa M Crane, Bryce Daniels, Barbara Lohse, Kelly Karavolos, Tami Olinger, Jacinda Nicklas, Lynda H Powell, Sumihiro Suzuki","doi":"10.1186/s13063-024-08703-8","DOIUrl":"https://doi.org/10.1186/s13063-024-08703-8","url":null,"abstract":"<p><strong>Background: </strong>Males are underrepresented in behavioral clinical trials of lifestyle. The aim of this exploratory study was to investigate factors associated with trial interest in males at different stages of recruitment and overall, into a multi-site behavioral trial targeting lifestyle change and remission of the metabolic syndrome. Similar analyses were performed for female participation to investigate the uniqueness or consistency with the findings for males.</p><p><strong>Methods: </strong>Data collected at various stages of recruitment in an ongoing multi-site behavioral clinical trial were used. A series of logistic regressions compared respondents who moved forward to the next step of the screening process versus those who did not. These analyses were stratified by sex. A chi-squared test was used to directly compare proportions of men and women who chose to advance to the next step.</p><p><strong>Results: </strong>Males who showed interest in the trial were more likely to be self-aware of their current health risk. Comparison of males and females showed that men tended to lose interest earlier in the recruitment process (58.3% of men vs. 66.5% of women attended an in-person information session, p < 0.001), but the proportion that moved forward among those who demonstrated initial interest was similar in men and women.</p><p><strong>Conclusion: </strong>Efforts to increase male enrollment in behavioral clinical trials will benefit from a focus on early stages of recruitment, aiming to increase potential participants' initial levels of interest and awareness of their health risk. As men and women differ in the reasons they choose to participate in a behavioral trial, recruitment should be tailored to sex to maximize trial participation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT04036006. Registered on July 29, 2019. https://clinicaltrials.gov/study/NCT04036006.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"844"},"PeriodicalIF":2.0,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"International workshop: what is needed to ensure outcome measures for Rett syndrome are fit-for-purpose for clinical trials? June 7, 2023, Nashville, USA.","authors":"Jenny Downs, Dominique C Pichard, Walter E Kaufmann, Joseph P Horrigan, Melissa Raspa, Gillian Townend, Eric D Marsh, Helen Leonard, Kathleen Motil, Andrew C Dietz, Nupur Garg, Amitha Ananth, Breanne Byiers, Sarika Peters, Christopher Beatty, Frank Symons, Aleksandra Jacobs, James Youakim, Bernhard Suter, Paramola Santosh, Jeffrey L Neul, Tim A Benke","doi":"10.1186/s13063-024-08678-6","DOIUrl":"https://doi.org/10.1186/s13063-024-08678-6","url":null,"abstract":"<p><strong>Introduction: </strong>The clinical, research and advocacy communities for Rett syndrome are striving to achieve clinical trial readiness, including having fit-for-purpose clinical outcome assessments. This study aimed to (1) describe psychometric properties of clinical outcome assessment for Rett syndrome and (2) identify what is needed to ensure that fit-for-purpose clinical outcome assessments are available for clinical trials.</p><p><strong>Methods: </strong>Clinical outcome assessments for the top 10 priority domains identified in the Voice of the Patient Report for Rett syndrome were compiled and available psychometric data were extracted. The clinical outcome assessments measured clinical severity, functional abilities, comorbidities and quality of life, and electrophysiological biomarkers. An international and multidisciplinary panel of 29 experts with clinical, research, psychometric, biostatistical, industry and lived experience was identified through International Rett Syndrome Foundation networks, to discuss validation of the clinical outcome assessments, gaps and next steps, during a workshop and in a follow-up questionnaire. The identified gaps and limitations were coded using inductive content analysis.</p><p><strong>Results: </strong>Variable validation profiles across 26 clinical outcome assessments of clinical severity, functional abilities, and comorbidities were discussed. Reliability, validity, and responsiveness profiles were mostly incomplete; there were limited content validation data, particularly parent-informed relevance, comprehensiveness and comprehensibility of items; and no data on meaningful change or cross-cultural validity. The panel identified needs for standardised administration protocols and systematic validation programmes.</p><p><strong>Conclusion: </strong>A pipeline of collaborative clinical outcome assessment development and validation research in Rett syndrome can now be designed, aiming to have fit-for-purpose measures that can evaluate meaningful change, to serve future clinical trials and clinical practice.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"845"},"PeriodicalIF":2.0,"publicationDate":"2024-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Time to look beyond (and before) journal reporting requirements: a review of ethnicity reporting in UK clinical trial results publications in three high-impact journals.","authors":"Mahwar Khanum, Shoba Dawson, Jhulia Dos Santos, Huda Hajinur, Carmel Conefrey, Sangeetha Paramasivan","doi":"10.1186/s13063-024-08596-7","DOIUrl":"https://doi.org/10.1186/s13063-024-08596-7","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"843"},"PeriodicalIF":2.0,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872914","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Irregular assessment times in pragmatic randomized clinical trials.","authors":"Andrea Apter, Frances K Barg, Sanjib Basu, Alex Federman, Winifred J Hamilton, Jerry A Krishnan, Tianjing Li, Russell Localio, Christine Pindle, Daniel O Scharfstein, Justin D Smith, Kaharu Sumino","doi":"10.1186/s13063-024-08676-8","DOIUrl":"https://doi.org/10.1186/s13063-024-08676-8","url":null,"abstract":"<p><p>Deviation from protocolized assessment times is commonplace in pragmatic randomized clinical trials. Working with a stakeholder advisory board for a Patient-Centered Outcomes Research Institute®-funded project on statistical methods for handling potential biases introduced by irregular assessment times, we identified reasons for off-schedule or missed assessments. We used the Consolidated Framework for Implementation Research 2.0 to organize our findings. We conjectured that timely completion of outcome assessments is a function of multiple determinants, only some related to participants' health status. We identified potential determinants that can be modified during the protocol design stage and can be reassessed and mitigated during trial implementation stage. Research to more formally evaluate our findings is warranted as well as studies to evaluate multi-level strategies that reduce off-schedule or missed assessments.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"841"},"PeriodicalIF":2.0,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142865593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perioperative methadone compared to placebo in elderly hip fracture patients: a study protocol for a randomized controlled trial (MetaHip trial).","authors":"Kevin Heebøll Nygaard, Thomas Strøm, Kirsten Specht, Sofie Ronja Petersen, Jesper Ougaard Schønnemann","doi":"10.1186/s13063-024-08694-6","DOIUrl":"https://doi.org/10.1186/s13063-024-08694-6","url":null,"abstract":"<p><strong>Background: </strong>Hip fractures are a source of severe pain among the elderly population and pose challenges due to limited analgesic tolerance. Perioperative methadone has shown promise in our pilot study suggesting a safe dose of 0.10 mg/kg, prompting further investigation into its benefits for elderly hip fracture patients.</p><p><strong>Methods: </strong>This study employs a double-blinded randomized controlled trial to assess the analgesic effects of a single dose of methadone during hip fracture surgery. Patients aged ≥ 60 years are consecutively enrolled and randomized to receive either perioperative methadone (treatment group) or a saline solution (placebo group). A sample size of 130 patients is required for 88% statistical power. The medication is administered intravenously at anesthesia induction and monitored until discharge. A follow-up observation is conducted 3 months post-surgery.</p><p><strong>Discussion: </strong>Primary outcome: Daily consumption of opioids within the first 3 days after surgery. Secondary outcomes include pain, mobility, nausea, vomiting, time to discharge, need for antidote, delirium, and constipation. The 3-month follow-up includes opioid use, pain, EQ-5D-5L scores, mobility, and persistent side effects. If statistically significant advantages are found in the treatment group, perioperative methadone could be considered as standard care for hip fracture patients, potentially enhancing their pain management. The study's outcomes will provide insights into the feasibility and effectiveness of incorporating methadone into routine clinical practices for this patient group.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT06086171, submitted 4. October 2023.</p><p><strong>Eu-ct: </strong>2023-506252-24-00, UTN: U1111-1294-6125.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"842"},"PeriodicalIF":2.0,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Process-based therapy vs. routine-CBT for difficult-to-treat mood and anxiety disorders: study protocol for a randomized controlled trial.","authors":"Ulrich Stangier, Viktoria Kohl, Nora Görg, Lucie Sendig, Bettina Hufschmidt, Desiree Bonarius, Arwin Nemani, Mareike Ebert, Stefan G Hofmann","doi":"10.1186/s13063-024-08689-3","DOIUrl":"https://doi.org/10.1186/s13063-024-08689-3","url":null,"abstract":"<p><strong>Background: </strong>Process-based therapy (PBT) is a new framework to intervention planning, based on the use of ecological momentary assessment (EMA) data and dynamic and idiographic network analyses. Support for its applicability has been reported from a single-case studies. Here, we examine the feasibility and effectiveness of PBT in a larger clinical sample. We have translated a training manual of PBT and modified for delivery of CBT in mental health service. The aim of this study is to test the relative efficacy of PBT compared to traditional CBT delivered in routine practice (r-CBT) for difficult-to-treat mood and anxiety disorders.</p><p><strong>Methods: </strong>The study is a randomized controlled trial (RCT) of PBT vs r-CBT for difficult-to-treat unipolar depression and anxiety disorders. In total, 80 patients are recruited at an outpatient clinic and included in two intervention arms. Primary outcome is emotional distress; secondary outcomes include psychological well-being and quality of life, adaptive behavior, psychological flexibility, and reflective functioning. Assessments of outcome variables are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes are collected for every session to investigate process of change. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and adherence with manual will be monitored using self-report.</p><p><strong>Discussion: </strong>The current study will be the first RCT of PBT in a health care setting. The planned moderator and mediator analyses will clarify the mechanisms of change in psychotherapy and the association between personalized assessment based on dynamic network analysis and treatment effect.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06517589. Registered 24 July 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"838"},"PeriodicalIF":2.0,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142865594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}