Trials最新文献

{"title":"Protocol of a randomized controlled trial on the effectiveness and cost-effectiveness of the PLACES intervention: a supported employment intervention aimed at enhancing work participation of unemployed and/or work-disabled cancer survivors","authors":"F. van Ommen, S. F. A. Duijts, P. Coenen, S. O. Dalton, A. Kliffen, R. van Hummel, A. G. E. M. de Boer, M. A. Greidanus","doi":"10.1186/s13063-024-08441-x","DOIUrl":"https://doi.org/10.1186/s13063-024-08441-x","url":null,"abstract":"Approximately onethird of cancer survivors encounter challenges reintegrating into the workforce, often experiencing involuntary unemployment and/or partial or full work disability following diagnosis and treatment. Returning to paid employment presents evident challenges due to uncertainties regarding work ability, perceived employer discrimination, and a lack of support, thereby risking social exclusion. However, interventions addressing return to paid employment among unemployed and/or work-disabled cancer survivors are scarce. Here, we describe the protocol of a randomized controlled trial (RCT), including a process and economic evaluation, evaluating the effectiveness and cost-effectiveness of the PLACES (unemPLoyed cAnCEr survivors Support) intervention aimed at supporting unemployed and/or work-disabled cancer survivors returning to paid employment. A two-armed RCT with a 12-month follow-up period will be conducted. Eligible participants: (1) are of working age (18–65 years), (2) are diagnosed with cancer between 6 months and 10 years ago, (3) are unemployed and/or partially or fully work-disabled, (4) have completed cancer treatment, and (5) are seeking paid employment and are motivated to initiate work immediately. Participants will primarily be identified through the Dutch Social Security Agency and the Netherlands Cancer Registry and recruited via healthcare professionals. Participants randomly allocated to the intervention group (n = 82) will receive the PLACES intervention: a tailored supported employment intervention based on the principles of Individual Placement and Support (IPS). This includes support in seeking, returning to, and maintaining paid employment. Participants allocated to the control group (n = 82) will receive care as usual. All participants will be asked to complete questionnaires, at baseline (T0), and after 3 (T1), 6 (T2), and 12 (T3) months of follow-up. The primary outcome is paid employment [yes/no]. Secondary outcomes are time until paid employment, change in working hours, work ability, quality of (working) life, and self-efficacy regarding return to work. Additionally, process and economic evaluations will be conducted. We hypothesize that the PLACES intervention will be effective in obtaining paid employment, enhancing work ability, and improving quality of life. In addition, we expect the intervention to be cost-effective. If proven effective and cost-effective, actions should be taken to implement the intervention in usual care. NCT06028048.","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142187975","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: The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials","authors":"Robin Chatters, Olivia Hawksworth, Steven Julious, Andrew Cook","doi":"10.1186/s13063-024-08453-7","DOIUrl":"https://doi.org/10.1186/s13063-024-08453-7","url":null,"abstract":"<p><b>Correction</b><b>: </b><b>Trials 25, 473 (2024)</b></p><p><b>https://doi.org/10.1186/s13063-024-08261-z</b></p><br/><p>Following the publication of the original article [1], we were notified that Additional file 2 had a few placeholders for the manuscript citation, which have now been added.</p><p>The original article has been corrected.</p><ol data-track-component=\"outbound reference\" data-track-context=\"references section\"><li data-counter=\"1.\"><p>Chatters, et al. The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials. Trials. 2024;25:473. https://doi.org/10.1186/s13063-024-08261-z.</p><p>Article PubMed PubMed Central Google Scholar </p></li></ol><p>Download references<svg aria-hidden=\"true\" focusable=\"false\" height=\"16\" role=\"img\" width=\"16\"><use xlink:href=\"#icon-eds-i-download-medium\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"></use></svg></p><h3>Authors and Affiliations</h3><ol><li><p>Shefeld Clinical Trials Research Unit (CTRU), Shefeld Centre for Health and Related Research (SCHARR), The University of Shefeld, Shefeld, UK</p><p>Robin Chatters & Olivia Hawksworth</p></li><li><p>Shefeld Centre for Health and Related Research (SCHARR), The University of Shefeld, Shefeld, UK</p><p>Steven Julious</p></li><li><p>Clinical Trials Unit, University of Southampton, Southampton, UK</p><p>Andrew Cook</p></li></ol><span>Authors</span><ol><li><span>Robin Chatters</span>View author publications<p>You can also search for this author in <span>PubMed<span> </span>Google Scholar</span></p></li><li><span>Olivia Hawksworth</span>View author publications<p>You can also search for this author in <span>PubMed<span> </span>Google Scholar</span></p></li><li><span>Steven Julious</span>View author publications<p>You can also search for this author in <span>PubMed<span> </span>Google Scholar</span></p></li><li><span>Andrew Cook</span>View author publications<p>You can also search for this author in <span>PubMed<span> </span>Google Scholar</span></p></li></ol><h3>Corresponding author</h3><p>Correspondence to Robin Chatters.</p><p><b>Open Access</b> This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public D","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142188035","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: Every Newborn-Reach Up Early Education Intervention for All Children (EN-REACH)- a parent group intervention for school readiness in Bangladesh, Nepal, and Tanzania: study protocol for a cluster randomized controlled trial","authors":"Mohammad Abdul Awal Miah, Jaya Chandna, Rejina Gurung, Nahya Salim Masoud, Proma Paul, Shafqul Ameen, Omkar Basnet, Mustafa Miraji, Cally Tann, Ismat Ara Mili, A K M Tanvir Hossain, Atique Iqbal Chowdhury, Asraful Alam, Kate Mackinnon Milner, Shams El Arifeen, Ashish KC, Karim Manji, Paul Lynch, Joy E. Lawn, Jena Derakhshani Hamadani","doi":"10.1186/s13063-024-08445-7","DOIUrl":"https://doi.org/10.1186/s13063-024-08445-7","url":null,"abstract":"<p><b>Correction</b><b>: </b><b>Trials 25, 556 (2024)</b></p><p><b>https://doi.org/10.1186/s13063-024-08381-6</b></p><br/><p>Following the publication of the original article [1], we were notified that administrative box under section Author details {5a} was not adjusted as per proof feedback.</p><p><b>Incorrect sequence:</b></p><p>6. School of Public Health and Community Medicine, University of Gothenburg, Sweden</p><p>7. School of Education, University of Glasgow, Glasgow, Scotland</p><p><b>Correct sequence:</b></p><p>6. Murdoch Children’s Research Institute, Department of Paediatrics, University of Melbourne, Melbourne, Australia</p><p>7. School of Public Health and Community Medicine, University of Gothenburg, Gothenburg, Sweden</p><p>8. School of Education, University of Glasgow, Glasgow, Scotland</p><p>The original article has been corrected.</p><ol data-track-component=\"outbound reference\" data-track-context=\"references section\"><li data-counter=\"1.\"><p>Miah, et al. Every Newborn-Reach Up Early Education Intervention for All Children (EN-REACH)- a parent group intervention for school readiness in Bangladesh, Nepal, and Tanzania: study protocol for a cluster randomized controlled trial. Trials. 2024;25:556. https://doi.org/10.1186/s13063-024-08381-6.</p><p>Article PubMed PubMed Central Google Scholar </p></li></ol><p>Download references<svg aria-hidden=\"true\" focusable=\"false\" height=\"16\" role=\"img\" width=\"16\"><use xlink:href=\"#icon-eds-i-download-medium\" xmlns:xlink=\"http://www.w3.org/1999/xlink\"></use></svg></p><span>Author notes</span><ol><li><p>Mohammad Abdul Awal Miah, Jaya Chandna, Rejina Gurung, and Nahya Salim Masoud contributed equally and shared frst authorship.</p></li><li><p>Ashish KC, Karim Manji, Paul Lynch, Joy E. Lawn, and Jena Derakhshani Hamadani shared senior authorship.</p></li></ol><h3>Authors and Affiliations</h3><ol><li><p>Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh</p><p>Mohammad Abdul Awal Miah, Shafqul Ameen, Ismat Ara Mili, A K M Tanvir Hossain, Atique Iqbal Chowdhury, Asraful Alam, Shams El Arifeen & Jena Derakhshani Hamadani</p></li><li><p>Maternal, Adolescent, Reproductive and Child Health (MARCH), London School of Hygiene and Tropical Medicine, London, UK</p><p>Jaya Chandna, Proma Paul, Cally Tann & Joy E. Lawn</p></li><li><p>Golden Community, Research Division, Lalitpur, Nepal</p><p>Rejina Gurung & Omkar Basnet</p></li><li><p>Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania</p><p>Nahya Salim Masoud, Mustafa Miraji & Karim Manji</p></li><li><p>Department of Paediatrics and Child Health, Temeke Regional Referral Hospital, Dar Es Salaam, Tanzania</p><p>Mustafa Miraji</p></li><li><p>Murdoch Children’s Research Institute, Department of Paediatrics, University of Melbourne, Melbourne, Australia</p><p>Kate Mackinnon Milner</p></li><li><p>School of Public Health and Co","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.5,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142188003","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":"Effectiveness of structured, multidisciplinary long-term care for pediatric cancer survivors: protocol of the multicenter, randomized-controlled AELKI study.","authors":"Hannah Schmidt, Katja Baust, Gabriele Calaminus, Lisa Hohls, Katharina Tetzner, Nicole Griech, Henrike Haugke, Hannah Baltus, Susanne Elsner, Alexander Katalinic, Hera Becker, Chirine Cytera, Judith Gebauer, Ann-Kristin Kock-Schoppenhauer, Anke Neumann, Christian Denzer, Michael M Schündeln, Jörg Faber, Conny Sattler, Michael C Frühwald, Anja Borgmann-Staudt, Anke Barnbrock, Markus Metzler, Gabriele Escherich, Inke R König, Ingo Menrath, Thorsten Langer","doi":"10.1186/s13063-024-08377-2","DOIUrl":"10.1186/s13063-024-08377-2","url":null,"abstract":"<p><strong>Background: </strong>In Germany, around 2.250 children and adolescents are diagnosed with cancer each year. Despite generally positive long-term survival rates, many patients must cope with late effects of the disease and its treatment. This highlights the need for a well-structured, long-term approach addressing both physical and mental health issues. Currently, the German healthcare system lacks such comprehensive structures. Our study aims to evaluate the effectiveness of a structured, multidisciplinary long-term approach compared to conventional \"treatment as usual\" (TAU).</p><p><strong>Methods: </strong>A prospective, multicenter study with ten pediatric university clinics in Germany will be conducted. The cluster-randomization takes place at the clinic level. Children and adolescents who completed their cancer treatment at least five years ago and their parents will be eligible to participate. While the control group (CG) receives TAU, the intervention group (IG) participates in a structured program. This program includes risk-based medical treatment and psychosocial interventions tailored to each patient's individual needs within a two-month timeframe. The primary outcome is the improvement of self-efficacy. Secondary outcomes are satisfaction with health care, improvement of health-related quality of life (HRQoL), reduction of mental health problems, and improvement of transition readiness.</p><p><strong>Discussion: </strong>This approach has the potential to optimize the health care for individuals who survived cancer during childhood or adolescence. It addresses the challenges of overuse, underuse, and misuse of health care resources. By considering both medical and psychosocial factors and promoting increased self-efficacy, independent from parental involvement, it may facilitate a smoother transition to adult medicine and enhance adherence to lifelong aftercare. If proven successful, this approach will contribute to the integration of multidisciplinary strategies into standard healthcare practice.</p><p><strong>Trial registration: </strong>German Clinical Trials Register DRKS00029269. Registered on December 23, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11382442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154987","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":"A phase II trial examining the safety and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) for people living with multiple sclerosis.","authors":"Natasha Stevens, Chigozie Ezegbe, Valery Fuh-Ngwa, Kalina Makowiecki, Amin Zarghami, Phuong Tram Nguyen, Julie Sansom, Kate Smith, Laura L Laslett, Meg Denham, Carlie L Cullen, Michael H Barnett, Mark R Hinder, Monique Breslin, Kaylene M Young, Bruce V Taylor","doi":"10.1186/s13063-024-08425-x","DOIUrl":"10.1186/s13063-024-08425-x","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) is a chronic neurological condition and the leading cause of non-traumatic disability in young adults. MS pathogenesis leads to the death of oligodendrocytes, demyelination, and progressive central nervous system neurodegeneration. Endogenous remyelination occurs in people with MS (PwMS) but is insufficient to repair the damage. Our preclinical studies in mice indicate that endogenous remyelination can be supported by the delivery of repetitive transcranial magnetic stimulation (rTMS). Our phase I trial concluded that 20 sessions of rTMS, delivered over 5 weeks, are safe and feasible for PwMS. This phase II trial aims to investigate the safety and preliminary efficacy of rTMS for PwMS.</p><p><strong>Methods: </strong>Participants must be aged 18-65 years, diagnosed with MS by a neurologist, stable and relapse free for 6 months, have an Extended Disability Status Scale (EDSS) between 1.5 and 6 (inclusive), willing to travel to a study site every weekday for 4 consecutive weeks, and able to provide informed consent and access the internet. Participants from multiple centres will be randomised 2:1 (rTMS to sham) stratified by sex. The intervention will be delivered with a Magstim Rapid2 stimulator device and circular 90-mm coil or MagVenture MagPro stimulator device with C100 circular coil, positioned to stimulate a broad area including frontal and parietal cortices. For the rTMS group, pulse intensity will be set at 18% (MagVenture) or 25% (Magstim) of maximum stimulator output (MSO), and rTMS applied as intermittent theta burst stimulation (iTBS) (~ 3 min per side; 600 pulses). For the sham group, the procedure will be the same, but the intensity is set at 0%. Each participant will attend 20 intervention sessions over a maximum of 5 weeks. Outcome measures include MS Functional Composite Score (primary), Fatigue Severity Scale, Hospital Anxiety and Depression Scale, Quality of Life, and Pittsburgh Sleep Quality Index/Numeric Rating Scale and adverse events (secondary) and advanced MRI metrics (tertiary). Outcomes will be measured at baseline and after completing the intervention.</p><p><strong>Discussion: </strong>This study will determine if rTMS can improve functional outcomes or other MS symptoms and determine whether rTMS has the potential to promote remyelination in PwMS.</p><p><strong>Trial registration: </strong>Registered with Australian New Zealand Clinical Trials Registry, 20 January 2022; ACTRN12622000064707.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11382484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142154986","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":"Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study.","authors":"Mais Iflaifel, Charlotte L Hall, Heidi R Green, Andrew Willis, Stefan Rennick-Egglestone, Edmund Juszczak, Mark Townsend, Jennifer Martin, Kirsty Sprange","doi":"10.1186/s13063-024-08435-9","DOIUrl":"10.1186/s13063-024-08435-9","url":null,"abstract":"<p><strong>Background: </strong>Ensuring diversity in clinical trials can be a challenge, which may be exacerbated when recruiting vulnerable populations, such as participants with mental health illness. As recruitment continues to be the major cause of trial delays, researchers are turning to online recruitment strategies, e.g. social media, to reach a wider population and reduce recruitment time and costs. There is mixed evidence for the use of online recruitment strategies; therefore, the REcruitment in Mental health trials: broadening the 'net', opportunities for INclusivity through online methoDs (RE-MIND) study aimed to identify evidence and provide guidance for use of online strategies in recruitment to mental health trials, with a focus on whether online strategies can enhance inclusivity. This commentary, as part of the RE-MIND study, focusses on providing recommendations for recruitment strategy selection in future research with the aim to improve trial efficiency. A mixed-methods approach was employed involving three work packages: (I) an evidence review of a cohort of 97 recently published randomised controlled trials/feasibility or pilot studies in mental health to assess the impact of online versus offline recruitment; (II) a qualitative study investigating the experiences of n = 23 key stakeholders on use of an online recruitment approach in mental health clinical trials; (III) combining the results of WP1 and WP2 to produce recommendations on the use of an online recruitment strategy in mental health clinical trials. The findings from WP1 and 2 have been published elsewhere; this commentary represents the results of the third work package.</p><p><strong>Conclusion: </strong>For external validity, clinical trial participants should reflect the populations that will ultimately receive the interventions being tested, if proven effective. To guide researchers on their options for inclusive recruitment strategies, we have developed a list of considerations and practical recommendations on how to maximise the use of online recruitment methods.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142146403","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":"SPIDOL study protocol for the assessment of intrathecal ziconotide antalgic efficacy for severe refractory neuropathic pain due to spinal cord lesions.","authors":"Andrei Brinzeu, Julien Berthiller, Nathalie Perreton, Fabien Subtil, Caroline Gervaise, Jacques Luaute, Patrick Mertens","doi":"10.1186/s13063-024-08387-0","DOIUrl":"10.1186/s13063-024-08387-0","url":null,"abstract":"<p><strong>Rationale: </strong>Central neuropathic pain resulting from spinal cord injury is notoriously debilitating and difficult to treat with few currently available treatments. A novel molecule with intrathecal administration: Ziconotide has been approved for treatment of refractory neuropathic pain in general. It acts as a presynaptic calcium channel blocker. A pilot study has shown its potential in SCI neuropathic pain patients.</p><p><strong>Objective: </strong>The aim of this study is to determine the long-term (6 months) efficacy of chronic intrathecal ziconotide for the treatment of neuropathic SCI pain.</p><p><strong>Study design: </strong>Multicenter, Randomized, Comparative, Placebo controlled, Double blind clinical trial, with a crossover of random alternated periods of 6 months (placebo or ITZ) for a total of 15 months including a total of 44 patients.</p><p><strong>Study population: </strong>• Patients with SCI of various etiologies exhibiting neuropathic pain refractory to non-invasive treatments. • > 18 years.</p><p><strong>Intervention: </strong>Intrathecal administration of ziconotide via an implanted pump.</p><p><strong>Study outcomes: </strong>Primary study outcome Difference in pain intensity for all patients between effective treatment and placebo periods. Secondary study outcomes 1. Continuous evaluation of pain intensity. 2. Percentage of patients with at least 30% of pain reduction. 3. Satisfaction level of the patient pain relief. 4. Declarations of serious adverse events. 5. Duration and intensity of spontaneous and provoked pain. 6. Quality of life. 7. Patient global impression of change. 8. Quantification of daily dosages of analgesic drug intake. 9. Long term memory and neurocognitive effects. 10. Assessment of the patient's physical and emotional distress. NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT, AND GROUP RELATEDNESS: Participation in this study is in accordance with current treatment protocols for SCI neuropathic pain in France therefore it proposes a treatment that would currently be considered regular practice even though no RCT evidence is yet available. The study gives patients the advantage of directly testing versus placebo a treatment that otherwise entails significant constraints. A Data Safety Monitoring board (DSMB) will be created for continuous safety analysis. Furthermore, patients will be followed in specialized pain centers offering the possibility of continuing their treatment after the study period.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142146401","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":"Thromboprophylaxis in oesophageal cancer patients-a study protocol for a randomised, controlled trial (TOP-RCT).","authors":"Tua Gyldenholm, Nina Madsen, Niels Katballe, Daniel Willy Kjær, Thomas Decker Christensen, Anne-Mette Hvas","doi":"10.1186/s13063-024-08408-y","DOIUrl":"10.1186/s13063-024-08408-y","url":null,"abstract":"<p><strong>Background: </strong>The purpose of the study is to examine if prolonged thromboprophylaxis decreases the risk of thrombosis after intended curative surgery for oesophageal cancer. Study results are expected to inform a guideline for thromboprophylaxis after oesophageal cancer surgery. The perspective is to reduce morbidity and mortality in this critically ill patient group. Thrombosis is the second-most common cause of cancer death after the cancer itself. The risk of thrombosis depends on the cancer type, and upper gastrointestinal cancers are considered high risk. This risk is further increased when patients undergo surgery. However, only few studies have investigated the peri- and postoperative coagulation profile in oesophageal cancer patients. Due to this lack of knowledge, prophylaxis is currently restricted to 5000 IU (international units) low-molecular weight heparin daily from surgery until discharge from hospital (approximately 10 days), whereas patients with gastric cancer receive 30 days of treatment. The present study examines whether a 30-day treatment is superior and safe, compared with the current standard treatment.</p><p><strong>Methods: </strong>The study is a randomised controlled trial. Inclusion is ongoing, and we aim to include 100 patients. Blood samples are drawn before and after surgery, and the coagulation is extensively examined. The primary endpoint is the difference in plasma levels of prothrombin fragment 1 + 2 (F1 + 2) 30 days after surgery between the intervention and the standard group. Furthermore, patients are examined with ultrasound to screen for asymptomatic venous thrombotic events (VTE). Secondary endpoints are incidence of bleeding, symptomatic and asymptomatic VTE and mortality 30 days 1 one year after surgery.</p><p><strong>Discussion: </strong>The study will provide valuable information on the perioperative coagulation profile and VTE risk of oesophageal cancer patients. The study seeks to aid in optimising the postoperative thromboprophylaxis, and the perspective is to reduce morbidity and mortality in this at-risk patient population.</p><p><strong>Trials registration: </strong>The trial was prospectively registered at the EU Clinical Trials Register with ID 2021-001335-24 on 30 June 2021 and at ClinicalTrials.gov with study identifier NCT05067153.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11378618/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142146402","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":"Formulation-based cognitive behavioral therapy compared to an active control and a waitlist in adult inmates with ADHD: study protocol for a randomized controlled trial.","authors":"Carlos López-Pinar, Sonia Martínez-Sanchís, Enrique Carbonell-Vayà, Jose Martínez-Raga, Wolfgang Retz","doi":"10.1186/s13063-024-08434-w","DOIUrl":"10.1186/s13063-024-08434-w","url":null,"abstract":"<p><strong>Background: </strong>Recent literature suggests that ADHD is a risk factor for the development of antisocial behavior that is more severe and persistent than in community and other psychiatric populations. The combination of stimulant medication and psychotherapy (particularly cognitive behavioral therapy, CBT) is considered an evidence-based intervention for adults with ADHD. In contrast, few studies have evaluated the efficacy of medication in adult prisoners with ADHD, and the literature on the efficacy of psychotherapy is virtually nonexistent. Therefore, this article presents the protocol of a trial that will assess the efficacy of a formulation-based CBT program for inmates with ADHD.</p><p><strong>Methods: </strong>The study has a multicenter randomized controlled trial design. After screening and recruitment, participants will be randomly assigned to the CBT intervention, a general offender treatment program, or a waitlist. Pre- and post-treatment self-report and clinician-report assessments, as well as 6- and 12-month follow-up assessments will be conducted. These will include both clinical (e.g., ADHD symptoms, depression and anxiety symptoms, self-esteem, alcohol/drug abuse, treatment adherence, quality of life) and criminological (e.g., recidivism and risk of recidivism) measures. Linear mixed models will be used to assess differences between groups.</p><p><strong>Discussion: </strong>This study may be the first to evaluate the efficacy of a psychotherapy intervention in adult inmates with ADHD. It is expected that addressing the specific needs of ADHD would not only result in the previously reported clinical improvements (e.g., reduction in ADHD and comorbidity symptoms), but also reduce the risk and rate of recidivism compared to the general intervention or no intervention. However, the design may be limited by the difficulties inherent in the prison setting and in following up the sample after release.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06080373. Registered on October 12, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11380400/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142146400","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of a soft exosuit on daily life gait performance in people with incomplete spinal cord injury: study protocol for a randomized controlled trial.","authors":"L Visch, B E Groen, A C H Geurts, I J W van Nes, N L W Keijsers","doi":"10.1186/s13063-024-08412-2","DOIUrl":"10.1186/s13063-024-08412-2","url":null,"abstract":"<p><strong>Background: </strong>People with incomplete spinal cord injury (iSCI) often have gait impairments that negatively affect daily life gait performance (i.e., ambulation in the home and community setting) and quality of life. They may benefit from light-weight lower extremity exosuits that assist in walking, such as the Myosuit (MyoSwiss AG, Zurich, Switzerland). A previous pilot study showed that participants with various gait disorders increased their gait speed with the Myosuit in a standardized environment. However, the effect of a soft exosuit on daily life gait performance in people with iSCI has not yet been evaluated.</p><p><strong>Objective: </strong>The primary study objective is to test the effect of a soft exosuit (Myosuit) on daily life gait performance in people with iSCI. Second, the effect of Myosuit use on gait capacity and the usability of the Myosuit in the home and community setting will be investigated. Finally, short-term impact on both costs and effects will be evaluated.</p><p><strong>Methods: </strong>This is a two-armed, open label, randomized controlled trial (RCT). Participants will be randomized (1:1) to the intervention group (receiving the Myosuit program) or control group (initially receiving the conventional program). Thirty-four people with chronic iSCI will be included. The Myosuit program consists of five gait training sessions with the Myosuit at the Sint Maartenskliniek. Thereafter, participants will have access to the Myosuit for home use during 6 weeks. The conventional program consists of four gait training sessions, followed by a 6-week home period. After completing the conventional program, participants in the control group will subsequently receive the Myosuit program. The primary outcome is walking time per day as assessed with an activity monitor at baseline and during the first, third, and sixth week of the home periods. Secondary outcomes are gait capacity (10MWT, 6MWT, and SCI-FAP), usability (D-SUS and D-QUEST questionnaires), and costs and effects (EQ-5D-5L).</p><p><strong>Discussion: </strong>This is the first RCT to investigate the effect of the Myosuit on daily life gait performance in people with iSCI.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov NCT05605912. Registered on November 2, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":null,"pages":null},"PeriodicalIF":2.0,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11378477/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142146399","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}