Trials最新文献

{"title":"Brain Injury and Ketamine study (BIKe): a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in severe traumatic brain injury patients.","authors":"Veerle De Sloovere, Liese Mebis, Pieter Wouters, Fabian Guïza, Eva Boonen, Marc Bourgeois, Jasperina Dubois, Didier Ledoux, Piet Lormans, Hugues Maréchal, Emmanuel Van der Hauwaert, Bart Depreitere, Geert Meyfroidt","doi":"10.1186/s13063-025-08835-5","DOIUrl":"https://doi.org/10.1186/s13063-025-08835-5","url":null,"abstract":"<p><strong>Background: </strong>In severe traumatic brain injury (TBI), sedatives are often used to control intracranial pressure (ICP), to reduce brain metabolism, to allow for other treatments such as mechanical ventilation or targeted temperature management, or to control paroxysmal sympathetic hyperactivity. Prolonged sedation is often necessary. The most commonly used sedatives in TBI are propofol and midazolam, often in combination, but both have significant side effects when used at high doses for several days. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, provides sedation and analgesia with minimal respiratory depression or haemodynamic instability. However, ketamine carries a US Food and Drug Administration (FDA) precaution regarding its use in patients with pre-anaesthetic elevated cerebrospinal fluid pressure, which discourages its use in TBI patients. Several observational studies and two large meta-analyses do not suggest that the use of ketamine as an induction agent or sedative in sedated and mechanically ventilated TBI patients would increase the ICP. Off-label use of ketamine for this indication is increasing worldwide. To date, no prospective randomized clinical trial (RCT) has demonstrated the safety of ketamine in TBI patients.</p><p><strong>Methods: </strong>The Brain Injury and Ketamine (BIKe) study is a prospective multicentre double-blind placebo-controlled RCT, to evaluate the safety, and effect on therapeutic intensity to reduce ICP, of ketamine as an adjunct to a standard sedation regimen in patients with severe TBI. Adult TBI patients, admitted to the intensive care unit (ICU), requiring sedation and ICP monitoring within 72 h of admission, will be randomized to ketamine or placebo. The study drug will be started within 6 h of randomization. The dose of the investigational medicinal product (IMP) is 1 mg/kg/h, by continuous infusion. The IMP will be stopped when the last ICP control sedative is discontinued. Data collection will stop when the patient is discharged from the ICU. All patients will be followed for 6 months post-trauma. The study is powered for the safety endpoint of detecting a clinically relevant increase of two episodes in the median number of episodes of high intracranial pressure episodes per ICU stay. A total of 100 patients are required to meet these objectives. We hypothesize a clinically relevant reduction in the therapeutic intensity level (TIL) score of at least 3 points.</p><p><strong>Discussion: </strong>This study is the first prospective RCT to investigate the safety of ketamine as an adjunct to a standard sedation regimen in TBI patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05097261. Registered on October 28, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"177"},"PeriodicalIF":2.0,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175084","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":"Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC): study protocol for a process evaluation of a complex intervention in home care service.","authors":"Ellen Thea Gjelseth Dalbak, Anette Væringstad, Bjørn Lichtwarck, Janne Myhre, Daniela Holle, Sverre Bergh, Øyvind Kirkevold","doi":"10.1186/s13063-025-08876-w","DOIUrl":"https://doi.org/10.1186/s13063-025-08876-w","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of frailty increases with older age. Frail and/or multimorbid patients are at risk for experiencing a crisis. Crises are major stressors for the patient, informal caregivers and formal caregivers and often lead to adverse events and hospitalization. The ongoing effectiveness study in the Preventing and approaching crises for frail community-dwelling patients through innovative care (PRACTIC) study is a cluster randomized controlled trial. This study will test the effectiveness of an adapted version of a biopsychosocial person-centred model, the Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME), to prevent and resolve crises for frail community-dwelling people receiving home care services. This current study protocol describes the process evaluation that will be conducted in parallel with the effectiveness study. The aims of this process evaluation are to explore factors and areas of importance in further implementation of the TIME model in home care services in Norway and to make causal assumptions about the effectiveness or lack of effectiveness of the intervention.</p><p><strong>Methods: </strong>The process evaluation will use mixed methods and integrate an exploratory and convergent design. To guide the process evaluation, we will use the Practical, Robust Implementation and Sustainability Model (PRISM) and Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) frameworks for following and evaluating the intervention with TIME. Data collection from municipal staff and home care service leaders will focus on the RE-AIM dimensions. Qualitative data will be obtained through focus group interviews and local project group meetings and analysed using thematic analyses. Quantitative data will be collected by staff questionnaires and will be analysed using descriptive statistics.</p><p><strong>Discussion: </strong>The PRACTIC study will enhance innovation in the development of new knowledge and a new approach towards each patient. This process evaluation will allow for a better understanding of the intervention and implementation of the complex TIME intervention in home care services. By analysing the RE-AIM dimensions, we will make causal assumptions about the effectiveness of the intervention. The findings will provide comprehensive knowledge of areas and factors of importance for the implementation of TIME in home care services.</p><p><strong>Trial registration: </strong>Parent trial NCT05651659 (ClinicalTrials.gov), first registered on 15th December 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"178"},"PeriodicalIF":2.0,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144175086","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":"School-based enhanced hearing screening and specialty telehealth follow-up for hearing loss among children in rural Alaska: study protocol for a hybrid effectiveness-implementation stepped wedge, cluster-randomized controlled trial (North STAR trial).","authors":"Samantha Kleindienst Robler, Janet Prvu Bettger, Elizabeth Turner, Alyssa Platt, David Arthur, Philip Hofstetter, Hannah Lane, Tarika Srinivasan, Shayu Deshpande, Matthew Hirschfeld, Susan D Emmett","doi":"10.1186/s13063-025-08864-0","DOIUrl":"https://doi.org/10.1186/s13063-025-08864-0","url":null,"abstract":"<p><strong>Background: </strong>Childhood hearing loss has well-known profound implications for language development, school achievement, and future employment opportunities. School-based health programs can provide hearing screening, but access to specialists for follow-up care is limited in rural areas. This is especially problematic for children in rural Alaska who experience a disproportionately high burden of preventable childhood hearing loss. The purpose of this study will be to develop and test the effectiveness and implementation of school-based specialty telehealth follow-up to improve timely access to specialty care after school hearing screening in rural Alaska.</p><p><strong>Methods: </strong>This will be a hybrid type 1 effectiveness-implementation stepped wedge, cluster-randomized trial in three representative regions of Alaska. The trial will evaluate the STAR model, which consists of three core components: (1) enhanced school hearing screening, (2) school-based specialty telehealth follow-up, and (3) streamlined communication between schools, healthcare providers, and parents/caregivers. The trial will begin with a formative phase in the first 2 years, when qualitative data on community preferences and perspectives will be gathered to systematically adapt the STAR model and develop an implementation plan for participating regions. The adapted STAR model will be evaluated with a stepped wedge, cluster-randomized design in approximately 25 schools in three regions of rural Alaska. The primary effectiveness outcome will be the proportion of referrals resulting in specialty follow-up within 60 days of school hearing screening, measured using queries of electronic health records from the healthcare systems serving each region. Generalized estimating equations (GEE) will be used to model these cluster-period school-level proportions to obtain population-averaged intervention effects that are of public health relevance and therefore of interest in implementation trials. Secondary implementation outcomes will include fidelity, reach, acceptability, feasibility, and appropriateness. Sustainability of the STAR model will be evaluated through iterative meetings with state leaders and policymakers.</p><p><strong>Discussion: </strong>This trial will evaluate school-based specialty telehealth follow-up in diverse regions of Alaska, addressing preventable childhood hearing loss with a model that could be translated to other rural and underserved groups to bring high-value services into rural schools and alter the paradigm of prevention nationwide.</p><p><strong>Trial registration: </strong>NCT05593484. Registered on October 20, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"175"},"PeriodicalIF":2.0,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144161109","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":"Why do patients take part in research? An updated overview of systematic reviews of psychosocial barriers and facilitators.","authors":"Peter Knapp, Peter Bower, Amber Lidster, Hugh O'Hare, Laura Ferreira Sol, Su Golder, Chris Keyworth, Adwoa Parker, Rebecca Sheridan","doi":"10.1186/s13063-025-08850-6","DOIUrl":"https://doi.org/10.1186/s13063-025-08850-6","url":null,"abstract":"<p><strong>Background: </strong>Efficient, equitable health research depends on understanding why people decide to take part. The aims of this overview were to update the version published in 2020, identifying psychosocial influences on participation and mapping them to recruitment research and psychological theory.</p><p><strong>Methods: </strong>Searches were undertaken in February 2024. Qualitative, quantitative, and mixed-methods systematic reviews were identified, without language or date limits. Methodological quality was rated using AMSTAR-2, and low-quality reviews were excluded. Barriers and facilitators were identified inductively and mapped to the Theoretical Domains Framework (TDF) and COM-B model, and to empirical recruitment research.</p><p><strong>Results: </strong>The update included 70 reviews, including 44 new reviews, covering a breadth of populations and settings, and drawing on 1940 primary studies (1428 unique). We identified 15 facilitators, most commonly: altruism, potential for personal benefit and trust. Incentives and convenient, low-burden research were also facilitators. Another 10 facilitators were new to this update. There were 16 barriers, most commonly: perceived risk, practical difficulties, and distrust of researchers. Many barriers applied to specific designs, particularly randomised trials. Factors that were barriers or facilitators include the influence of others and information quality. Barriers and facilitators were coded to the Motivation and Opportunity components of the TDF, particularly knowledge and social influences; only two factors were coded to a Capability. Psychosocial influences and empirical recruitment research had some overlap, but some barriers and facilitators had not been evaluated.</p><p><strong>Conclusions: </strong>Common barriers and facilitators to research participation were identified, some new to this update, which could be addressed through targeted recruitment strategies to increase the efficiency and generalisability of primary research. Factors affecting participation are not only personal; they are also normative and social. The priorities are to change the ways we recruit to research (perhaps tested in SWATs) and identify barriers and facilitators in areas not well covered in current research.</p><p><strong>Trial registration: </strong>PROSPERO CRD42017062738. Registered on April 2017.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"174"},"PeriodicalIF":2.0,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144161111","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":"Fentanyl or esketamine for traumatic pain (FORE-PAIN) trial: study protocol for a double-blind multi-arm randomized non-inferiority trial.","authors":"Midas N de Grunt, Nurseda Risvanoglu, Johannes A Siegers, Maurice A G M Kroon, Maruschka P Merkus, Markus W Hollmann, Milan L Ridderikhof, Robert P Weenink","doi":"10.1186/s13063-025-08869-9","DOIUrl":"https://doi.org/10.1186/s13063-025-08869-9","url":null,"abstract":"<p><strong>Background: </strong>Although fentanyl and esketamine, administered intravenously (IV) or intranasally (IN), are standard of care for treatment of acute traumatic pain in the prehospital setting in the Netherlands, comparative evidence regarding their efficacy and safety is lacking. Therefore, this study aims to assess the efficacy and safety of fentanyl IN, esketamine IV and esketamine IN as compared to fentanyl IV for management of acute traumatic pain in the prehospital setting.</p><p><strong>Methods: </strong>This is a double-blind, monocenter, multi-arm, randomized non-inferiority trial in the prehospital setting in the Netherlands. Adult subjects receiving emergency care from Emergency Medical Services Ambulance Amsterdam and suffering from acute severe traumatic pain are randomized in an 1:1:1:1 ratio to receive fentanyl IV (1.0 µg/kg), fentanyl IN (1.25 µg/kg), esketamine IV (0.2 mg/kg), or esketamine IN (0.625 mg/kg). The primary endpoint is the reduction in Numeric Rating Scale (NRS, 0-10) score at 10 min after first administration of study medication. The prespecified non-inferiority margin is 1.0 for the between-group absolute difference in primary outcome. The primary endpoint is analyzed according to the intention-to-treat and per-protocol principles conforming to recommendations for non-inferiority analysis. Other endpoints include reduction in NRS score at other timepoints, need for additional analgesia, patient satisfaction, and adverse events.</p><p><strong>Discussion: </strong>This trial is one of few double-blind randomized controlled trials in the prehospital setting and aims to answer questions that have relevance to prehospital practice. Research in a prehospital emergency setting also comes with challenges, including concerns about prehospital data quality, limited research experience among personnel and a limited timeframe for data collection and follow-up. Also, informed consent needs to be deferred.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06051227. Registered on 9 September 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"172"},"PeriodicalIF":2.0,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144152094","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 use of remimazolam versus propofol for anesthesia induction in video-assisted thoracoscopic surgery: study protocol for a multicenter randomized controlled trial.","authors":"Lu Zhang, Juan Yang, Lu Zhou, Hong Yu, Bin Liu, Leng Zhou","doi":"10.1186/s13063-025-08833-7","DOIUrl":"https://doi.org/10.1186/s13063-025-08833-7","url":null,"abstract":"<p><strong>Background: </strong>Intraoperative hypotension may result in a higher incidence of postoperative myocardial injury, acute kidney injury, and stroke. Notably, more than half of intraoperative hypotension cases occur immediately after induction of general anesthesia. Although intraoperative hypotension has multiple causes, post-induction hypotension is primarily due to the effects of anesthetic drugs. Propofol is the most widely used agent for anesthesia induction. However, propofol can induce hemodynamic instability, potentially leading to adverse postoperative outcomes. Remimazolam, a novel ultra-short-acting intravenous sedative-hypnotic, may promote stable hemodynamics. Studies have reported that remimazolam is associated with less hypotension compared to propofol. Therefore, this study aims to compare the hemodynamic effects of remimazolam and propofol during anesthesia induction in patients undergoing video-assisted thoracoscopic surgery.</p><p><strong>Methods: </strong>This is a prospective, multicenter randomized controlled trial. A total of 172 patients aged 45 to 65 years undergoing video-assisted thoracoscopic surgery will be randomly allocated to receive remimazolam or propofol during anesthetic induction. The primary outcome is the incidence of hypotension occurring within 20 min after anesthesia induction. Hypotension is defined as systolic blood pressure (SBP) of less than 90 mmHg, or a reduction of more than 30% in SBP from baseline, or the administration of vasoactive medication. Secondary outcomes include the rate of successful sedation, time to successful sedation, coughing during the induction period, postoperative delirium within 7 days after surgery, and postoperative in-hospital mortality.</p><p><strong>Discussion: </strong>To date, remimazolam has rarely been used for anesthesia induction in video-assisted thoracoscopic surgery. This study will provide important information on hemodynamic stability and anesthesia efficacy of remimazolam in this surgical setting.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2400085556. Registered on 12 th June 2024, http://www.chictr.org.cn/ .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"173"},"PeriodicalIF":2.0,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144151341","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":"Community-based promotion of physical activity in Nepal: study protocol for a cluster-randomized controlled trial.","authors":"Rajan Shrestha, Tara Ballav Adhikari, Bijay Khatri, Dinesh Neupane, Susan Paudel, Rasmus Østergaard Nielsen, Sebastian Deisting Skejø, Abhinav Vaidya, Per Kallestrup","doi":"10.1186/s13063-025-08885-9","DOIUrl":"10.1186/s13063-025-08885-9","url":null,"abstract":"<p><strong>Background: </strong>Globally, one in four adults does not meet the WHO-recommended at least 150 min of moderate intensity physical activity per week. Insufficient physical activity is the fourth-leading risk factor, contributing to 9% of global premature mortality. Physical activity is effective in weight management, cardiorespiratory fitness, and enhancing the quality of life. A high proportion (43.1%) of people living in semi-urban areas of Nepal have insufficient physical activity. Limited evidence shows a lack of knowledge and motivation as major barriers to physical activity in Nepal. Female Community Health Volunteers (FCHVs) in Nepal are effectively contributing to community-based maternal, neonatal, child, and reproductive health and the detection and management of non-communicable diseases. They could potentially contribute to physical activity promotion in community settings.</p><p><strong>Methods and design: </strong>The study aims to evaluate the effectiveness of a FCHV-led community-based intervention on change in daily moderate to vigorous physical activity (MVPA) minutes. We plan to conduct an open-label cluster-randomized controlled trial with 1:1 allocation in semi-urban areas of Pokhara Municipality, Nepal. In this trial, we will recruit 264 adults 18-69 years from 14 included clusters. Axivity AX3 accelerometer and the Global Physical Activity Questionnaire (GPAQ) will be used to measure physical activity before and after the six-month intervention. FCHVs will deliver community-based educational intervention through household visits for three months, to motivate participants for physical activity through interactive health education sessions. The primary outcome is the mean change in MVPA minutes per day. Secondary outcomes include changes in physical activity intention, health-related quality of life, stress, anxiety, depression, cardiometabolic health indicators, and sleep quality.</p><p><strong>Discussion: </strong>This study will objectively explore physical activity among adults in a Nepali community and provide evidence on the effectiveness of a FCHV-led community-based intervention on physical activity promotion in Nepal.</p><p><strong>Trial registration: </strong>ClinicalTrial.gov NCT06386692. Registered on 26 April 2024.</p><p><strong>Trial registration in nepal: </strong>Ethical Review Board, Nepal Health Research Council, Protocol number 726/2023, approved on 8th February 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"170"},"PeriodicalIF":2.0,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12102969/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143634","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":"Polyacrylic acid-polyvinylpyrrolidone complex for achieving hemostasis after hemodialysis: study protocol for an open-label crossover randomized controlled trial (PAA-PVP study).","authors":"Ryohei Terashima, Mototsugu Tanaka, Atsushi Hashimoto, Daiki Omori, Takahiro Tanaka, Haruna Miyazawa, Masahiro Ishizawa, Yoshihiko Tomita, Tomoko Ito, Yoshiyuki Koyama, Kokichi Saito, Suguru Yamamoto, Shin Goto, Ichiei Narita","doi":"10.1186/s13063-025-08877-9","DOIUrl":"10.1186/s13063-025-08877-9","url":null,"abstract":"<p><strong>Background: </strong>Achieving rapid and secure hemostasis of the vascular access point is important for patients undergoing maintenance hemodialysis (HD). We developed a polyacrylic acid-polyvinylpyrrolidone (PAA-PVP) complex that absorbs moisture such as blood or sterilizing solution, forms a hydrogel, and adheres to the body's surface, thereby exerting a powerful hemostatic effect. This study aims to compare the effect of PAA-PVP complex versus a conventional non-woven fabric pad on hemostasis at the needle puncture vascular access site in patients on HD.</p><p><strong>Methods: </strong>This open-label crossover randomized controlled trial will include 50 participants who undergo thrice-weekly HD. Participants in whom hemostasis requires more than 10 min by compression using a conventional pad or who have a severe skin problem at the needle puncture vascular access site will be excluded from the study. Participants will be randomized in a 1:1 ratio to receive either the PAA-PVP complex or conventional pads. Three consecutive weekly hemostatic tests will be performed at 11, 9, 7, 5, 3, and 1 min. The study will employ an individual 3+3 design in which participants in whom hemostasis is achieved in all three sessions in a week will be challenged to a shorter time in the three sessions of the next week. Those in whom hemostasis is achieved in two of three sessions will be tested at the same time point in the three sessions of the next week. The study treatment will be terminated if hemostasis is achieved in only one or none of the sessions, and the minimum time with three consecutive successes will be recorded as the hemostasis time. The primary endpoint, the hemostasis time on the arterial side of the vascular access, will be analyzed using mixed-effect models for repeated measures and include the hemostatic technique and group, period, and individual effects as covariates.</p><p><strong>Discussion: </strong>The study will provide evidence on whether the PAA-PVP complex reduces hemostasis time of the vascular access compared to conventional pad in patients on HD.</p><p><strong>Trial registration: </strong>jRCTs032220597 (Japan Registry of Clinical Trials; registered on January 30, 2023, https://jrct.niph.go.jp/latest-detail/jRCTs032220597 ).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"171"},"PeriodicalIF":2.0,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12103747/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144143641","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":"Rationale and design for a community-engaged intervention addressing the intergenerational transmission of adverse childhood experiences (ACEs): a hybrid implementation-effectiveness study protocol.","authors":"Jini E Puma, Dave LaRocca, Betsy Risendal, Sharon Scarbro, Beth McManus, Danielle Varda, Jenn A Leiferman","doi":"10.1186/s13063-025-08881-z","DOIUrl":"10.1186/s13063-025-08881-z","url":null,"abstract":"<p><strong>Background: </strong>Adverse childhood experiences (ACEs) are traumatic experiences (e.g., abuse) that can have a profound negative effect on a child's developing brain and body with lasting deleterious impacts on a person's mental health and chronic disease risk throughout the lifespan. Exposure to ACEs is often repeated generation to generation. STANCE (Supporting Trauma Awareness and Nurturing Children's Environments) was developed, in partnership with a rural community in Colorado, to prevent the intergenerational transmission of ACEs. STANCE is employing community-based participatory research (CBPR) principles to develop and test a multi-level community intervention to promote socioemotional development in young children, enhance parenting skills, and strengthen a comprehensive system of care to meet the needs of young families who have experienced ACEs.</p><p><strong>Methods: </strong>An effectiveness-implementation hybrid study of STANCE is being conducted in the San Luis Valley of Colorado, a rural community with a majority Hispanic population. The primary effectiveness outcomes are being evaluated in a pragmatic public health trial using a stepped-wedge cluster randomized design that includes 16 early childhood education centers. A mixed-methods, prospective case study with a social network analysis approach will inform the primary implementation outcomes which were drawn from the Consolidated Framework for Implementation Research (CFIR).</p><p><strong>Discussion: </strong>This study evaluates the effectiveness and implementation of an ACEs prevention intervention for young children and families living in a rural community. If successful, this trial will inform the use of evidence-based intervention strategies to address ACEs and provide a framework for dissemination and implementation to other rural communities.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"169"},"PeriodicalIF":2.0,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12103003/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144133253","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":"Staged Turnbull-Cutait pull-through anastomosis comparing with direct anastomosis plus prophylactic ileostomy in the treatment of low rectal cancer after internal sphincter resection (STAR-TAR): study protocol for a randomized controlled trial.","authors":"Wenhao Chen, Jianhua Ding, Jianbin Xiang, Yanlei Wang, Jiagang Han, Hui Ye, Donghua Wang, Binghu Lin, Junping Lei, Xiangbai Wu, Maojun Di, Yan Fu, Guiyi Yang, Chuanhui Qin, Aijun Chen, Jun Xu, Wenming Liu, Congqing Jiang","doi":"10.1186/s13063-025-08845-3","DOIUrl":"10.1186/s13063-025-08845-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Recent advancements in the understanding of lower rectum anatomy, rectal cancer biology, and surgical techniques have emphasized the importance of radical surgery for low rectal cancer that balances oncological safety and anal function preservation. After total mesorectal excision (TME) and coloanal anastomosis, participants face high risks of anastomotic leakage and infection, often requiring a protective ileostomy. However, ileostomies themselves lead to significant complications, such as dehydration and chronic renal failure, and many participants cannot have their stomas reversed as planned. The Turnbull-Cutait procedure, involving delayed transanal pull-through rectal resection, has emerged as a safer alternative, reducing leakage complications and avoiding the need for a protective stoma. Recent studies support its use in challenging rectal cases, showing comparable or better outcomes than standard techniques. Despite these promising results, limited data exists on its application to intersphincteric resection (ISR) or intersphincteric dissection (ISD), which itself has higher complication rates. Therefore, further research is needed to evaluate this Turnbull-Cutait anastomosis procedure (delayed transanal pull-through) in ISR, comparing its complications, oncological outcomes, and functional results to those of traditional methods (direct anastomosis). This study is a prospective, multicenter, 1:1, non-inferiority, randomized controlled trial with 110 participants, divided into two groups: the staged Turnbull-Cutait pull-through anastomosis group (n = 55) and the direct anastomosis group (n = 55). The control group will undergo ISR with traditional anastomosis plus protective ileostomy, while the experimental group will receive the transanal pull-through and delayed anastomosis without ileostomy. The primary outcome is the 30-day overall postoperative complication rate, including anastomotic leakage, infection, and other complications. Secondary outcomes include long-term complications, total surgery time, anorectal function (measured by LARS and Wexner scores), urinary and sexual function, quality of life (EORTC QLQ-CR29 and FIQL), and 3-year disease-free survival (DFS) and overall survival (OS).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;Currently, there is a lack of systematic studies exploring the use of delayed pull-through anastomosis in intersphincteric resection (ISR) procedures. Existing research on this technique in low rectal cancer is limited to small, single-center, retrospective studies with low levels of evidence. Therefore, a multicenter, prospective, randomized controlled trial is needed to determine whether delayed pull-through anastomosis can serve as a viable alternative to ISR-coloanal anastomosis, offering comparable or lower rates of postoperative complications, as well as similar oncological outcomes and defecatory function. This study aims to provide higher-quality evidence through a larger,","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"168"},"PeriodicalIF":2.0,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12096633/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144128939","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}