Trials最新文献

{"title":"Topical tacrolimus for the amelioration of breast cancer-related lymphedema (TACLE Trial): a study protocol for a randomized, double-blind, placebo-controlled phase II/III trial.","authors":"Frederik Gulmark Hansen, Mads Gustaf Jørgensen, Jørn Bo Thomsen, Jens Ahm Sørensen","doi":"10.1186/s13063-025-08829-3","DOIUrl":"https://doi.org/10.1186/s13063-025-08829-3","url":null,"abstract":"<p><strong>Background: </strong>Breast cancer-related lymphedema is a chronic condition affecting 15-30% of breast cancer patients, resulting from treatment-related inflammation and fibrosis primarily mediated by CD4 + T-cells. Tacrolimus, an immunomodulator, has shown efficacy in reducing lymphedema in both animal models and an initial clinical trial. This study aims to validate these findings in a larger cohort, hypothesizing that tacrolimus will reduce lymphedema volume, fibrosis, and fluid retention while improving quality of life.</p><p><strong>Methods: </strong>This multicenter, double-blinded, randomized placebo-controlled trial will enroll 80 women with breast cancer-related lymphedema stages I and II. Participants will be randomized 1:1 to receive either 0.1% tacrolimus ointment or a placebo ointment for 12 months. Primary outcome will be the change in lymphedema volume measured at baseline, 6 months, and 12 months. Secondary outcomes include quality of life assessed via SF- 36, DASH, and LYMPH-Q Upper Extremity questionnaires; lymphedema index via bioimpedance spectroscopy; lymphatic function and flow via indocyanine green lymphangiography; and skin fibrosis measurement. Assessments will take place at baseline, 3, 6, 9, and 12 months.</p><p><strong>Discussion: </strong>This trial will provide robust data on the efficacy of topical tacrolimus in reducing BCRL volume and improving patient quality of life. Positive results could establish tacrolimus as a standard treatment for BCRL, potentially enhancing clinical outcomes for affected patients. The findings will also contribute to understanding the role of immunomodulation in lymphedema management.</p><p><strong>Trial registration: </strong>This trial is registered with the EU Clinical Trials Information System (CTIS) under EU CT Number: 2023-503644 - 13-00 (approved 16.05.2024) and ClinicalTrials.gov under identifier NCT06306274 (registered 12.03.2024).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"127"},"PeriodicalIF":2.0,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143812321","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":"Safety and efficacy of different rotational speed during rotational atherectomy in coronary heart disease patients (RACE): study protocol for a randomized controlled trial.","authors":"Jie Xu, Yu-Wei Wang, Li-Kun Ma, Hao Hu, Hong-Wu Chen, Jing-Sheng Hua, Xiang-Yong Kong, Dan Li, Long-Wei Li, Jia-Wei Wu","doi":"10.1186/s13063-025-08834-6","DOIUrl":"10.1186/s13063-025-08834-6","url":null,"abstract":"<p><strong>Introduction: </strong>The increasing incidence of coronary heart disease, driven by socio-economic development and population aging, poses significant challenges. Coronary calcification, a major factor complicating percutaneous coronary interventions (PCI), often necessitates rotational atherectomy (RA) for lesion preparation. However, the impact of different RA rotational speeds on procedural and clinical outcomes remains unclear. While low-speed RA (LSRA) has been suggested to reduce intraoperative slow flow, evidence is inconsistent, and the benefits of combining LSRA with high-speed RA (HSRA) are not well established. This study aims to evaluate the effectiveness of different rotational speed protocols to guide clinical practice.</p><p><strong>Methods and analysis: </strong>This single-center, randomized controlled trial will target patients with severe coronary artery calcification scheduled for RA. An estimated 210 patients will be enrolled based on sample size calculation, randomly assigned in a 1:1:1 ratio to different rotational speed protocols using a random number table. These will include a continuous low-speed rotation (LSRA) group (140,000 rpm), a continuous high-speed rotation (HSRA) group (180,000 rpm), and a high-speed to low-speed rotation (HSRA + LSRA) group (initially 180,000 rpm, followed by 100,000 rpm). The primary endpoint is the incidence of complications during RA, including coronary artery spasm, slow/no reflow, dissection, burr entrapment, guidewire fracture, and perforation. Secondary outcomes encompass intravascular imaging (IVUS or OCT) assessments (detecting calcific ring disruption and measuring the target lesion's minimum lumen area (MLA) and minimum lumen diameter (MLD)); in-hospital cardiac death, acute stent thrombosis, and heart failure occurrences; and the 1-year incidence of major adverse cardiovascular and cerebrovascular events (MACCE).</p><p><strong>Discussion: </strong>The RACE study evaluates the impact of different rotational speeds in coronary rotational atherectomy, aiming to provide guidance for clinical practice. The findings may help standardize RA procedures and inform future clinical guidelines, improving procedural consistency and patient outcomes.</p><p><strong>Registration number: </strong>ChiCTR2300076194. Registered on September 27, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"126"},"PeriodicalIF":2.0,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804363","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":"Digital therapeutics approach for young children with myopia using SAT-001 (DAYS): study protocol for a randomized controlled trial.","authors":"Hae Jung Paik, Byung Joo Lee, Dong Hui Lim, So Young Han, Eun Hye Jung, Hyun Jin Shin, Hyun Kyung Kim, Ungsoo Samuel Kim, Won Jae Kim, Hee Young Choi, Jihae Park, Soolienah Rhiu, Jihye Lee, Moonjeong Kim, Kyunghee Kim","doi":"10.1186/s13063-025-08717-w","DOIUrl":"https://doi.org/10.1186/s13063-025-08717-w","url":null,"abstract":"<p><strong>Background: </strong>Myopia is a prevailing refractive disorder and rapidly increases the risk of vision-threatening conditions. Earlier intervention is crucial to suppress myopia progression; however, the pharmacological and non-pharmacological therapies currently available have limitations. SAT-001 is a novel digital therapeutic software developed for myopia control and is designed to overcome the limitations of existing therapies. The present study aims to evaluate the efficacy and safety of the software as a medical device, SAT-001, for the inhibition of myopia progression and treatment in pediatric patients with myopia.</p><p><strong>Methods: </strong>This clinical trial is a two-arm, prospective, randomized, open-label study with a duration of approximately 25 months, comprising a maximum of 52 weeks of participant participation. We will enroll 110 pediatric patients with myopia aged 5 to < 9 years, each with a spherical equivalent of - 0.75 D to - 5.75 D in each eye. Eligible participants will be randomly assigned in a 1:1 ratio to either the study group using SAT-001 with single-vision spectacles or the control group using single-vision spectacles alone. The change in the spherical equivalent refractive error (SER) at 48 weeks from baseline serves as the primary endpoint. The change in SER at 24 weeks and axial length at every 12 weeks from baseline will be the secondary endpoints. Each change will be assessed depending on the myopic severity. Treatment emergent adverse events will be evaluated for the safety analysis.</p><p><strong>Discussion: </strong>This randomized controlled trial aims to confirm the efficacy and safety of SAT-001 in slowing pediatric myopia progression. The findings of this study could establish SAT-001 as an easily accessible, convenient, and non-invasive treatment option with minimal side effects, offering long-term myopia control from an early stage. Further research is needed to validate the effectiveness of SAT-001 for moderate to high myopia and concurrent conditions like astigmatism and to improve user engagement, diversify the program, and integrate with hospital-based treatments.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT06344572 ; date of registration: April 12, 2024 (retrospectively registered).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"128"},"PeriodicalIF":2.0,"publicationDate":"2025-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143812312","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":"Evaluation of maxillary miniscrew-anchored molar distalization appliance versus clear aligners in adult with Class II malocclusion: study protocol for a randomized controlled trial.","authors":"Hao Liu, Ziyan Tang, Zhicheng Gong, Cui Ye, Haimiao Wu","doi":"10.1186/s13063-025-08827-5","DOIUrl":"10.1186/s13063-025-08827-5","url":null,"abstract":"<p><strong>Background: </strong>Angle Class II malocclusion typically presents with overbite, distal molar relationship, and crowding of the upper anterior teeth. The distal movement of the maxillary molars is considered an optimal treatment strategy, as it can circumvent the need for orthodontic extraction. Clear aligners are currently used for molar distalization. However, this approach is not without its limitations, including the loss of anterior tooth anchorage and an extended treatment duration. To address these issues, this study introduces a novel molar distalization appliance. A clinical randomized controlled trial will compare the efficacy of this appliance with clear aligners, specifically assessing differences in the rate of tooth movement.</p><p><strong>Methods: </strong>This study will recruit 30 patients aged 18-35 with Angle Class II malocclusion, characterized by distal molar relationship, mild to moderate crowding, or protrusion of anterior teeth. Patients will be randomly divided into two groups: the experimental group using a novel molar distalization appliance, and the control group using clear aligners for molar distalization. Both groups will use orthodontic miniscrews as an anchorage, with elastic traction for molar distalization. Cone-beam CT and digital dental models will be collected before orthodontic intervention and after molar distalization for all samples. This study will register pre- and post-treatment images using maxillary bone structures and then analyze three-dimensional tooth movement. The study will further calculate the distance of molar distal movement per unit time as the tooth movement rate and compare whether there is a difference between the experimental and control groups.</p><p><strong>Discussion: </strong>This randomized controlled trial will serve as evidence that the novel molar distalization device, compared to clear aligners, whether offers advantages such as shorter treatment duration and superior control of tooth movement. It can provide a novel method for orthodontic clinical treatment of patients with Angle Class II malocclusion.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ChiCTR2300069122. Registered on 7 March 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"123"},"PeriodicalIF":2.0,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804362","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":"Effects of the Informed Health Choices secondary school intervention on the ability of lower secondary students in Kenya to think critically about health choices: 1-year follow-up of a cluster-randomized trial.","authors":"Faith Chesire, Margaret Kaseje, Violet Gisore, Michael Mugisha, Ronald Ssenyonga, Matt Oxman, Allen Nsangi, Daniel Semakula, Christopher James Rose, Laetitia Nyirazinyoye, Simon Lewin, Nelson K Sewankambo, Sarah Rosenbaum, Jenny Moberg, Andrew D Oxman","doi":"10.1186/s13063-025-08810-0","DOIUrl":"10.1186/s13063-025-08810-0","url":null,"abstract":"<p><strong>Introduction: </strong>The Informed Health Choices (IHC) secondary school intervention aimed to teach students to assess claims about treatments. This follow-up of a cluster randomized trial assessed the retention of knowledge and the application of the nine prioritized IHC key concepts 1 year after the intervention.</p><p><strong>Methods: </strong>We conducted a random assignment of 80 secondary schools in Western Kenya into either the intervention (n = 40) or control (n = 40) group. Both groups adhered to the standard curriculum. Teachers from the intervention group were invited to participate in a 2-day training workshop and were granted access to \"Be Smart About Your Health\" digital resources, comprising 10 lessons. These lessons, focused on nine prioritized IHC concepts, delivered over a single school term from May to August 2022. The digital resources were accessible online via smartphones or computers and could also be downloaded for offline use. The primary outcome measure, assessed at the end of the school term and again after 1 year, was the percentage of students achieving a passing score (defined as ≥ 9 out of 18 correct answers) on the \"Critical Thinking about Health\" test.</p><p><strong>Results: </strong>Out of the total 3360 students involved in the trial, 2446 (72.8%) completed the test after 1 year. Within the intervention group, 728 out of 1369 students (53.2%) achieved a passing score after 1 year, compared to 61.7% immediately post-intervention. In contrast, in the control group, 347 out of 1077 students (32.2%) had a passing score after 1 year. The adjusted difference in passing rates between the intervention and control groups after 1 year was 20.8% (with a 95% confidence interval of 13.6 to 28.0%), compared to 27.3% (with a 95% confidence interval of 19.6 to 34.9%) immediately after the intervention.</p><p><strong>Conclusion: </strong>This study demonstrates that students were able to retain knowledge and the ability to apply the IHC key concepts, 1 year after the intervention. But fewer students in the intervention group had a passing score after 1 year compared to just after the intervention. Highlighting follow-up training is likely necessary to reinforce these skills over time.</p><p><strong>Trial registration: </strong>Pan African Clinical Trial Registry, trial identifier: PACTR202204883917313. Registered on 05/04/2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"125"},"PeriodicalIF":2.0,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804361","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":"Correction: Effects and mechanisms of supramaximal high-intensity interval training on extrapulmonary manifestations in people with and without chronic obstructive pulmonary disease (COPD-HIIT): study protocol for a multi-centre, randomized controlled trial.","authors":"Johan Jakobsson, Chris Burtin, Mattias Hedlund, Carl-Johan Boraxbekk, Jonas Westman, Nina Karalija, Per Stål, Thomas Sandström, David Ruttens, Harry R Gosker, Jana De Brandt, André Nyberg","doi":"10.1186/s13063-025-08830-w","DOIUrl":"10.1186/s13063-025-08830-w","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"124"},"PeriodicalIF":2.0,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804360","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":"Effects of opioid-free anesthesia combined with iliofascial nerve block on perioperative neurocognitive deficits in elderly patients undergoing hip fracture surgery: study protocol for a prospective, multicenter, parallel-group, randomized controlled trial.","authors":"Tong Zhi, Shirong Wei, Jiao Kuang, Sitong Zhou, Danhong Yu, Tesheng Gao, Long Lei, Chengfei Xu, Liang Cheng, Qinghe Zhou, Ming Yao, Huadong Ni","doi":"10.1186/s13063-025-08828-4","DOIUrl":"10.1186/s13063-025-08828-4","url":null,"abstract":"<p><strong>Background: </strong>Perioperative neurocognitive dysfunction (PND), a prevalent complication affecting elderly surgical patients, poses substantial challenges to postoperative rehabilitation and long-term functional independence. Despite growing awareness of its clinical significance, current evidence regarding effective neuroprotective anesthetic strategies remains inconclusive. Where emerging evidence suggests opioid-free anesthesia (OFA) strategies could maintain analgesic efficacy while potentially attenuating opioid-associated neuroinflammatory mechanisms implicated in PND pathogenesis. This multicenter trial investigates the efficacy of OFA combined with ultrasound-guided iliofascial nerve block in mitigating PND among geriatric patients undergoing hip fracture surgery.</p><p><strong>Methods: </strong>This multicenter, randomized controlled trial will enroll 348 patients, who will be randomly assigned to receive either OFA combined with iliofascial nerve block or opioid-based anesthesia (OBA) combined with iliofascial nerve block. All patients will undergo hip fracture surgery under general anesthesia with tracheal intubation. The primary outcome will be the change in composite neurocognitive scores, assessed through a battery of neuropsychological tests from baseline to 3 months postoperatively. Secondary outcomes include alterations in serum protein and inflammatory markers, extubation time, postoperative pain incidence, intraoperative hemodynamic stability, and postoperative recovery parameters. The safety profile of OFA in hip surgery will also be assessed.</p><p><strong>Discussion: </strong>Effective prevention of PND is crucial for optimizing postoperative recovery and long-term functional outcomes in elderly patients. This trial aims to refine and optimize anesthesia management strategies to reduce the incidence of PND, improve postoperative quality of life, and ultimately enhance perioperative neurocognitive outcomes.</p><p><strong>Trial registration: </strong>This trial protocol was registered with the China Clinical Trial Registry on December 14, 2023, under the registration number: ChiCTR2300078647.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"122"},"PeriodicalIF":2.0,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11972513/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143789242","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":"Time, money, and weight loss: a qualitative study exploring patients' perspectives on randomization for bariatric surgery vs. an intensive non-surgical weight loss program.","authors":"Sofie Amalie Tomova-Olsen, Marius Brostrøm Kousgaard, Katrine Tranberg Jensen, Susanne Reventlow, Ann-Kathrin Lindahl Christiansen, Kirstine Nyvold Bojsen-Møller, Carsten Dirksen, Gritt Overbeck","doi":"10.1186/s13063-025-08816-8","DOIUrl":"10.1186/s13063-025-08816-8","url":null,"abstract":"<p><strong>Background: </strong>Randomized controlled trials (RCTs) are foundational in advancing medical knowledge and patient care, offering high-quality evidence on the comparative effectiveness of healthcare interventions. However, a common challenge for RCTs is the recruitment of trial participants. To understand and overcome potential obstacles in recruitment for a clinical trial (the LightBAR trial, NCT06309238) comparing the effectiveness of bariatric surgery versus an intensive weight loss program, a qualitative study was conducted.</p><p><strong>Methods: </strong>Nine patients from the public bariatric surgery waiting list participated in focus groups at a hospital in the Capital Region of Denmark. Vignette scenarios were utilized to prompt participants to reflect on barriers and facilitators for participation. Three patients participated in a follow-up interview. Data was analyzed using thematic analysis.</p><p><strong>Results: </strong>Analysis revealed four main themes: (1) having waited long for surgery reduced participants' willingness to be randomized; (2) the cost of weight loss medication was a major concern for participants; (3) participants were concerned about the extra work involved in program participation; and (4) participants weighed the efficacy and potential negative side effects of surgery against those of an intensive weight loss program based on personal beliefs and experiences.</p><p><strong>Conclusions: </strong>Tailoring the recruitment strategy to patients' circumstances and concerns, and providing clear, patient-centered communication about the nature and potential implications of participating in the trial may improve recruitment success.</p><p><strong>Trial registration: </strong>The LightBAR trial (NCT06309238). Registered on ClinicalTrials.gov on May 2, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"121"},"PeriodicalIF":2.0,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11971855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143789243","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":"Pragmatic clustered randomised control trial to evaluate a self-regulated learning intervention to be implemented in South Australian primary schools-study protocol.","authors":"S A Brinkman, B Lam, S Dawson, R Marrone, D Schunk, K Winkel, H Hermes, F Gabriel, S Fowler, D Engelhardt","doi":"10.1186/s13063-025-08814-w","DOIUrl":"10.1186/s13063-025-08814-w","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Self-regulated learning (SRL) is described as a process whereby learners actively take control of their learning by setting goals, planning, monitoring, evaluating, and adjusting their learning strategies to improve performance and achieve desired outcomes Panadero (Front Psychol 8:422, 2017). SRL proficiency has been shown to predict educational success and lifelong outcomes, such as income and health. While SRL is recognised as a key lifelong competency, there remain questions regarding how educators can best develop and promote SRL in school settings. A scalable, low-cost intervention targeted at grade 1 students (6-7 years old) in Germany was found to have substantial effects on impulse control and self-regulated learning, with sustained impacts on long-term academic success Schunk (Nat Hum Behav 6(12):1680-90, 2022). This study protocol seeks to adapt the Schunk et al. (2022) randomised trial to the Australian content and extend it to grades levels 2, 4 and 6.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We will use a standard pragmatic clustered (by school) randomised controlled superiority trial with an additional population-wide matched parallel control arm. Effectively, we will conduct three trials-one for each age/grade level. Each trial will be powered to assess the impact of the intervention on the age/grade groups independently: grade 2 (early primary, 7-8 years), grade 4 (mid primary, 9-10 years), and grade 6 (late primary, 11-12 years). Schools assigned to the treatment group will have all three grade levels (grades 2, 4, and 6) receiving the treatment (at least one class per grade); no classes in the schools assigned to the control group will receive the intervention. A minimum of 56 schools with an average cluster size of 19 children/class will be required to detect a minimum impact of 0.25 SD effect size at 80% power taking into account the clustered design with an intraclass correlation coefficient (ICC) of 0.05. This results in a total sample of 1064 per grade and thus 3192 students in total (56 schools per arm × 19 students in an average-sized class × three grade levels). Randomisation will occur on a 1:1 ratio, such that half of the schools (n = 28), and effectively about half of the students (n = 1596) will receive the intervention. The primary outcome will be improved self-regulation assessed at 6 weeks, 6 months and 12 months post the intervention. Longer-term secondary outcomes will include academic and wellbeing measures obtained through administrative data linkage to the National Assessment Program in Literacy and Numeracy (NAPLAN) outcomes and the Wellbeing and Engagement Collection (WEC) outcomes measures in the year following implementation (grades 3, 5, and 7). Follow-up via the South Australia Data Linkage Systems will allow for longer-term academic outcomes, mental health, school completion, criminal justice, and tax data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;This protocol paper provides a detail","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"120"},"PeriodicalIF":2.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11967115/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143781235","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":"Immunoadsorption study Mainz in adults with post-COVID syndrome (IAMPOCO)-a single-blinded sham-controlled crossover trial to evaluate the effect of immunoadsorption on post-COVID syndrome.","authors":"Marco Stortz, Pascal Klimpke, Andreas Kommer, Philipp Gründer, Livia Steenken, Christian Dresel, Daniel Kraus, Irene Schmidtmann, Arndt Weinmann, Julia Weinmann-Menke","doi":"10.1186/s13063-025-08825-7","DOIUrl":"10.1186/s13063-025-08825-7","url":null,"abstract":"<p><strong>Background: </strong>Post-COVID syndrome (PCS) affects up to 43% of all SARS-CoV-2-infected persons and describes ongoing symptoms months after the acute infection. Despite the large number of affected people, there is still very little evidence about therapeutic options. Some studies suggest at least partially a role of autoantibody-mediated autoimmunity. Immunoadsorption is an extracorporeal therapy to remove circulating antibodies which is used successfully in several autoimmune diseases. We conceived the IAMPOCO trial to evaluate the therapeutic effect of immunoadsorption in patients with PCS.</p><p><strong>Methods: </strong>IAMPOCO is a single-center randomized sham-controlled trial with a crossover design which will enroll 40 participants with PCS and a symptom severity of at least 2 on post-COVID functional scale. All participants will undergo 5 immunoadsorption treatments and after a washout period of 8 weeks 5 sham treatments or vice versa. Which modality is conducted first will be randomized. Patients but not providers of therapy are blinded for which modality is conducted. Primary outcome is the efficacy of IA to the severity of PCS measured by the change of several symptom scores and hand grip strength. Secondary outcomes are the frequency of adverse events and the prevalence of relevant autoantibodies in participants with PCS as well as the concentration of autoantibodies before and after therapy and sham treatment.</p><p><strong>Discussion: </strong>The trial addresses the lack of evidence for treatment options in PCS. By using a crossover design and including a sham treatment arm, the study aims to compare the effects of immunoadsorption and sham therapy within the same patients. The trial also benefits from recruiting participants from a cohort study on PCS prevalence, ensuring a thorough evaluation of symptoms. Objective assessments of symptoms are challenging due to their subjective nature, but various scoring systems and tests are being utilized. Despite the lack of data from RCTs, the results of this study have the potential to significantly improve PCS therapy and support evidence-based treatment decisions.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05841498. Registered on May 3, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"119"},"PeriodicalIF":2.0,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11966871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143773462","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}