Trials最新文献

{"title":"Effects on tricuspid regurgitation by different techniques for passing permanent pacemaker leads through the tricuspid valve: a randomized, open-label, superiority clinical trial study protocol.","authors":"Jianan Hong, Zhanyi Qiu, Zhongbo Xiao, Xiaobin Ni, Yanling Fang, Shiwan Wu, Yandan Xie, Chang Chen, Yequn Chen, Muli Wu","doi":"10.1186/s13063-024-08630-8","DOIUrl":"10.1186/s13063-024-08630-8","url":null,"abstract":"<p><strong>Background: </strong>In recent years, lead-induced tricuspid regurgitation (LITR) has attracted increasing attention. At present, there are two commonly used transvalvular methods for pacing lead wires to enter the right ventricle. The first transvalvular approach involves placing the tip of the pacing lead directly through the tricuspid valve into the right ventricle, including \"direct-crossing\" and \"drop-down.\" The second transvalvular approach is to bend the pacing lead so that the reflexed lead body crosses the tricuspid valve and then enters the right ventricle, which is \"prolapsing.\" However, there are no clinical trials to evaluate or compare the effects of the above two different pacing lead transvalvular approaches on tricuspid regurgitation. In this study, we will perform a randomized clinical trial to understand the effect of different transvalvular lead wire transversal techniques on the incidence of tricuspid regurgitation.</p><p><strong>Methods: </strong>Three hundred seventy-six subjects with right ventricular single-chamber pacemaker implantation or dual-chamber pacemaker implantation were recruited in the First Affiliated Hospital of Shantou University Medical College. Participants will be randomized into the direct group (\"direct-crossing\" and \"drop-down\") or the bending group (\"prolapsing\"). The primary objective will be new tricuspid regurgitation or exacerbation of existing tricuspid regurgitation within 1 year of follow-up.</p><p><strong>Discussion: </strong>This study aims to verify whether different transvalvular approaches influence the incidence of LITR, and is expected to provide an optimized method for routine pacemaker surgery and improve the long-term prognosis and quality of life of patients.</p><p><strong>Trial registration: </strong>Chinese Clinical Trials Registry ChiCTR2100045558. Registered on April 19, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"772"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568686/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644588","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":"Intravenous versus oral iron supplementation for iron deficiency anemia in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy: a study protocol for a randomized controlled trial.","authors":"Hyeung-Min Park, Jaram Lee, Soo Young Lee, Chang Hyun Kim, Hyeong Rok Kim","doi":"10.1186/s13063-024-08624-6","DOIUrl":"10.1186/s13063-024-08624-6","url":null,"abstract":"<p><strong>Background: </strong>Numerous studies have been conducted to manage anemia in surgical patients through iron supplementation as an alternative to blood transfusion. However, patients with locally advanced rectal cancer have often been excluded from these studies, due to their standard treatment involving neoadjuvant chemoradiotherapy. This study aims to evaluate the impact of intravenous versus oral iron supplementation on iron deficiency anemia in patients with rectal cancer receiving preoperative chemoradiotherapy.</p><p><strong>Methods: </strong>This open-label, single-center, parallel, superiority, randomized trial includes patients with primary rectal cancer who are candidates for preoperative chemoradiotherapy and have confirmed iron-deficiency anemia. A total of 94 patients will be randomly assigned in a 1:1 ratio to receive either intravenous or oral iron supplementation. Stratification factors include age (> 70 vs. ≤ 70 years) and baseline serum hemoglobin levels (7-10 g/dL vs. 10-13 g/dL). The primary endpoint is the percentage of patients achieving normalized hemoglobin levels from the start of treatment to the day of admission for surgery. Secondary endpoints include changes in serum hemoglobin from baseline to postoperatively, changes in iron assay parameters, time needed to hemoglobin normalization, volume of blood transfusions required, and incidence of postoperative complications.</p><p><strong>Discussion: </strong>This study is the first randomized controlled trial investigating the effect of iron supplementation in iron-deficient patients with rectal cancer undergoing neoadjuvant chemoradiotherapy. This trial is expected to provide evidence for the benefits of administering iron supplementation in patients with rectal cancer undergoing neoadjuvant chemoradiotherapy.</p><p><strong>Trial registration: </strong>Clinical Research Information Service (CRIS) of Republic of Korea, KCT0009260, Registered on March 21, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"771"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644830","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Normal saline versus lactated Ringer's solution for acute pancreatitis resuscitation, an open-label multicenter randomized controlled trial: the WATERLAND trial study protocol.","authors":"Lucía Guilabert, Karina Cárdenas-Jaén, Alicia Vaillo-Rocamora, Ana García García de Paredes, Ankit Chhoda, Sunil G Sheth, Carlos López-Valero, Pedro Zapater, Eva M Navarrete-Muñoz, Patrick Maisonneuve, Yasmin G Hernández-Barco, Gabriele Capurso, James L Buxbaum, Enrique de-Madaria","doi":"10.1186/s13063-024-08581-0","DOIUrl":"10.1186/s13063-024-08581-0","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"769"},"PeriodicalIF":2.0,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566695/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644659","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":"Theoretically-informed vs standard cover letter to improve participant response to mailed questionnaire: results of an embedded randomised retention trial.","authors":"Colin C Everett, Sarah T Brown, Joanna L Dennett, Howard Collier, Claire L Davies, Frances Game, E Andrea Nelson","doi":"10.1186/s13063-024-08565-0","DOIUrl":"10.1186/s13063-024-08565-0","url":null,"abstract":"<p><strong>Background: </strong>Participant non-response is a source of bias in all research, especially in randomised controlled trials. Participants followed up remotely can have high non-response rates. Four such trials have been conducted of a cover letter with content informed by behaviour change theory to overcome hypothesised barriers to responding to a mailed questionnaire. Pooled results to date have suggested further research to be worthwhile. We conducted an embedded randomised study within a trial of such cover letters in the hope that we would improve response rates to our postal quality of life questionnaires.</p><p><strong>Methods: </strong>One hundred forty-eight participants in the CODIFI2 diabetic foot ulcer sampling trial were randomised 1:1 to receive one of two different cover letters at follow-up timepoints: either a standard cover letter accompanying their postal follow-up questionnaires or to an 'enhanced' (theory-informed) cover letter. Questionnaires were mailed at 39, 52 and (for some participants) 104 weeks post randomisation. Outcome measures were response to mailing at each timepoint. Analysis was restricted to those for whom a questionnaire and letter was issued. Owing to limited recruitment, a reduced analysis plan, comprising solely observed response rates and 95% confidence intervals for difference in response rates was followed. Post hoc, we added our week 52 results to an already-published meta-analysis.</p><p><strong>Results: </strong>Sixty-seven out of 74 enhanced cover letter group (Enhanced) and 67/74 standard cover letter group (Standard) participants who had not already died or withdrawn were sent their first mailing at 39 weeks. The 39-week response rates were 47/67 (70.1%) and 39/67 (58.2%) for Enhanced and Standard participants, respectively. At week 52, the response rates were 45/64 (70.3%) and 35/63 (55.6%) for Enhanced and Standard participants, respectively. At week 104, the response rates were 24/33 (72.7%) and 19/33 (57.6%) for the Enhanced and Standard participants, respectively. Adding our week 52 results to a published meta-analysis increased the pooled estimate of differences in response rates to 0.04 (- 0.01 to 0.09) favouring enhanced letters.</p><p><strong>Conclusion: </strong>While this embedded randomised controlled trial observed greater response rates at all times among those randomised to the enhanced letter, the reduced sample size meant that these results are imprecise.</p><p><strong>Trial registration: </strong>ISRCTN registry ISRCTN74929588. Registered on 5 March 2019.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"763"},"PeriodicalIF":2.0,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11562673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628645","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":"Impact of different weaning strategies of high-frequency ventilation (HFV) on neonatal cerebral oxygen saturation and hemodynamics: protocol for a prospective randomized controlled trial.","authors":"Wenli Liu, Tao Xiong, Jun Tang, Jing Shi, Chao Chen, Yi Huang, Ke Tian, Rong Zhou, Zhu Yuan, Aoyu Wang, Jun Zhu","doi":"10.1186/s13063-024-08621-9","DOIUrl":"10.1186/s13063-024-08621-9","url":null,"abstract":"<p><strong>Background: </strong>High-frequency ventilation (HFV) is commonly used in neonatal intensive care units to provide respiratory support for critically ill neonates. Currently, there is no standardized procedure for weaning from HFV. Two commonly used strategies are transitioning from HFV to conventional mechanical ventilation (CMV) before extubation (HFV-CMV) and extubation after decreasing mean airway pressure during HFV (HFV-HFV). The impact of these strategies on neonatal cerebral oxygenation and hemodynamics remains incompletely understood.</p><p><strong>Methods: </strong>We will conduct a prospective, single-center, randomized controlled trial to investigate the effects of two different HFV weaning strategies (HFV-CMV, HFV-HFV) on neonatal cerebral oxygenation and hemodynamics. The patients enrolled in the trial will be randomly allocated to either the HFV-CMV group or the HFV-HFV group in a 1:1 ratio. The primary outcome will be cerebral oxygen saturation (S_cO₂) before and after the intervention. Second outcomes are cerebral fractional tissue oxygen extraction, heart rate, blood pressure, and the incidence and severity of intraventricular hemorrhage and periventricular leukomalacia. We hypothesize that HFV-CMV results in positive impact on neonatal cerebral oxygenation compared to HFV-HFV. This study aims to identify a better weaning strategy for HFV and contribute evidence-based data to enhance its clinical application in newborns, potentially improving the care and outcomes for neonates receiving HFV.</p><p><strong>Discussion: </strong>This study aims to assessing the impact of different HFV weaning strategies on neonatal cerebral oxygenation and hemodynamics, as well as the relationship between the duration of HFV under different strategies and neurological complications, to identify better weaning methods for HFV. We hope to contribute evidence-based data to enhance clinical application of HFV in newborns, potentially improving the care and outcomes for neonates receiving HFV.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry: ChiCTR2400088628. Registered on August 22, 2024, https://www.chictr.org.cn/bin/project/edit?pid=235926 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"765"},"PeriodicalIF":2.0,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566609/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142627884","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":"Identification and transfer to stepped care of depressed and psychosocially stressed parents during peri- and postpartum-UPlusE: study protocol for cluster randomized trial of a screening intervention.","authors":"Ulrike Stentzel, Neeltje van den Berg, Freya Lanczik, Andrea Gehrmann, Ina Nehring, Volker Mall, Anna Friedmann, Carolin Seivert, Stefanie Schade, Christoph Fusch, Sarah Kittel-Schneider, Susanne Simen","doi":"10.1186/s13063-024-08610-y","DOIUrl":"10.1186/s13063-024-08610-y","url":null,"abstract":"<p><strong>Background: </strong>Perinatal depression affects 10-15% of mothers and approximately 5% of fathers. However, only a small number of affected individuals seek treatment. If left unrecognized and untreated, it can have negative long-term consequences for the family's health, leading to subsequent high costs. Early treatment is crucial, yet there is a notable underdiagnosis and undertreatment. Affected individuals are often seen during this time, e.g. in paediatric practices, but not by specialists in mental health. Consequently, this study aims to increase detection and treatment rates of affected individuals by implementing a screening for depression and psychosocial stress in perinatal and postpartum parents within routine obstetric and paediatric care with subsequent advice and-if necessary-further referral to a mental health specialist.</p><p><strong>Methods: </strong>UPlusE is a prospective, cluster-randomized controlled trial conducted in an outpatient setting. Obstetric and paediatric practices will be randomized into an intervention and control group (1:1 ratio). Practices and enrolling patients will be required to use specific smartphone apps (practice apps) for interaction. The screening will occur with the apps at each paediatric checkup up to the child's age of 12 months, using the Edinburgh Postnatal Depression Scale (EPDS), KID-PROTEKT questionnaire, and the scale 1 (impaired bonding) of the Postpartum Bonding Questionnaire (PBQ-1). The goal is to screen 10,000 patients across Germany. Gynaecologists and paediatricians will receive certified training on peripartum depression. Participants in the intervention group with scores above cut-offs (EPDS ≥ 10, KID-PROTEKT ≥ 1, PBQ-1 ≥ 12) will receive counselling through their treating gynaecologists/paediatricians and will be provided with regional addresses for psychiatrists, psychotherapists, and \"Frühe Hilfen\" (early prevention) as well as family counselling centres, depending on symptom severity. At each screening, participants will be asked whether they sought support, where, and with whom (utilization). Utilization is the primary outcome.</p><p><strong>Discussion: </strong>The screening is designed to reduce underdiagnosis to enable suitable support at an early stage (especially for those often overlooked, such as individuals with \"high-functioning depression\") and hence to avoid manifestation of mental health problems in the whole family, especially infants who are exceptionally dependent on their parents and their well-being will benefit from this program.</p><p><strong>Trial registration: </strong>German Clinical Trials Register, DRKS00033385. Registered on 15 January 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"766"},"PeriodicalIF":2.0,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142627485","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":"Supporting diversity in clinical trials: the equitable breakthroughs in medicine site maturity model.","authors":"Tesheia Harris, Marcella Nunez-Smith, Sakinah C Suttiratana, Samantha L Fretz, Savannah Leonard, Erika Linnander, Leslie A Curry","doi":"10.1186/s13063-024-08594-9","DOIUrl":"10.1186/s13063-024-08594-9","url":null,"abstract":"<p><strong>Background: </strong>Among the most powerful barriers to broader inclusion of diverse participants in clinical trials are social determinants of health, trustworthiness of health care providers and research institutions, and competing pressures on potential participants. Nevertheless, current tools to assess organizational capabilities for clinical trial diversity focus primarily on trial infrastructure, rely solely on quantitative self-reported data, and lack meaningful assessment of capabilities related to community engagement.</p><p><strong>Methods: </strong>The Equitable Breakthroughs in Medicine (EQBMED) initiative developed a holistic, collaborative, site-driven formative model and accompanying assessment to catalog sites' current capabilities and identify opportunities for growth in both conducting industry-sponsored clinical trials and enriching diversity of those trials. The model builds upon prior work and reflects unification of two historically distinct components-research operations and community engagement-since sustainable clinical trial diversity efforts must overcome these silos. Here we present the methodology we used to develop the model and accompanying assessment, describe how findings can support clinical trial diversity efforts, and report findings from early field testing at three U.S. sites.</p><p><strong>Results: </strong>The first three sites were diverse in size (e.g., < 250-1 K beds), with varying levels of clinical trial capabilities and community engagement. The maturity assessment laid the foundation for sites to identify and prioritize key areas to advance clinical trial diversity capabilities, and each has made tangible progress. In parallel to completing the assessment with these early sites to understand their maturity and set actionable goals, we also collected their feedback on content validity (e.g., clarity, comprehensiveness, terminology) and feasibility (e.g., ability to collect needed information and data, time required). We describe refinements made to improve the assessment and streamline the process. The EQBMED program will deploy the assessment across various site types (e.g., FQHCs, safety net hospitals) and make further refinements as warranted.</p><p><strong>Conclusions: </strong>Strategic investment in clinical trial diversity requires structured assessment of site maturity as a starting point for collaborative action. We propose the EQBMED maturity model as a first step toward informing efforts to increase representation of diverse populations in clinical research.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"764"},"PeriodicalIF":2.0,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566401/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628638","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":"The BrEasT cancer afTER-CARE (BETTER-CARE) programme to improve breast cancer follow-up: design and feasibility study results of a cluster-randomised complex intervention trial.","authors":"Anna Horn, Julia Wendel, Isabella Franke, Armin Bauer, Harald Baumeister, Eileen Bendig, Sara Y Brucker, Thomas M Deutsch, Patricia Garatva, Kirsten Haas, Lorenz Heil, Klemens Hügen, Helena Manger, Rüdiger Pryss, Viktoria Rücker, Jessica Salmen, Andrea Szczesny, Carsten Vogel, Markus Wallwiener, Achim Wöckel, Peter U Heuschmann","doi":"10.1186/s13063-024-08614-8","DOIUrl":"10.1186/s13063-024-08614-8","url":null,"abstract":"<p><strong>Background: </strong>The risk of breast cancer patients for long-term side effects of therapy such as neurotoxicity and cardiotoxicity as well as late effects regarding comorbidities varies from individual to individual. Personalised follow-up care concepts that are tailored to individual needs and the risk of recurrences, side effects and late effects are lacking in routine care in Germany.</p><p><strong>Methods: </strong>We describe the methodology of BETTER-CARE, a parallel-arm cluster-randomised controlled trial conducted at 15 intervention and 15 control centres, aiming to recruit 1140 patients, and the results of the pilot phase. The needs- and risk-adapted complex intervention, based on existing development frameworks, includes a multidisciplinary network and digital platforms for symptom and need documentation and just-in-time adaptive interventions. The control group comprises usual care according to clinical guidelines. The primary outcome is health-related quality of life (EORTC QLQ-C30 global health), and secondary outcomes include treatment adherence.</p><p><strong>Results: </strong>The 2-month pilot phase comprising 16 patients in one intervention and one control pilot centre demonstrated the feasibility of the BETTER-CARE approach.</p><p><strong>Discussion: </strong>BETTER-CARE is a feasible intervention and study concept, investigating individualised needs- and risk-adapted breast cancer follow-up care in Germany. If successful, the approach could be implemented in German routine care.</p><p><strong>Trial registration: </strong>German Clinical Trial Register DRKS00028840. Registered on April 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"767"},"PeriodicalIF":2.0,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628690","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":"Induction of Cure in Early Arthritis (I CEA): study protocol for an investigator-initiated randomized single-blind clinical trial with open-label extension to compare three treatment strategies in patients with newly diagnosed undifferentiated arthritis.","authors":"S A Bergstra, L van Ouwerkerk, I S Nevins, J A van der Pol, G S Helmich, I Hest, A van Veen, R Bos, Y P M Goekoop-Ruiterman, H E Vonkeman, J Bijsterbosch, P H P de Jong, M Güler-Yüksel, S Böhringer, T W J Huizinga, F A van Gaalen","doi":"10.1186/s13063-024-08609-5","DOIUrl":"10.1186/s13063-024-08609-5","url":null,"abstract":"<p><strong>Background: </strong>Undifferentiated arthritis (UA) is a term used to describe patients with inflammatory arthritis that has not differentiated into a specific rheumatic disease. UA may be a pre-stage of rheumatoid arthritis (RA) or another inflammatory disease or remain undifferentiated, but a substantial proportion of patients may also achieve spontaneous remission. As UA may be an early presentation of RA, rheumatologists often start methotrexate (or another csDMARD) as early as possible. There are however very little data on the potential benefits of early DMARD treatment, and longitudinal data suggests that long-term outcomes such as physical functioning hardly improved in these patients in the past decades. In the I CEA trial, we investigate if it is beneficial to start early treatment with MTX or baricitinib, a more rapidly acting drug with a broader mechanism of action, compared to waiting for spontaneous remission with symptomatic therapy in patients with UA.</p><p><strong>Methods: </strong>The I CEA is a multicenter single-blind (independent assessor) randomized clinical trial with a 3-month interventional and 9-month observational follow-up period. The study includes patients with early (< 1 year symptom duration) DMARD-naïve undifferentiated arthritis. Patients with an increased risk of AEs with baricitinib treatment are excluded. Participants are randomized 1:1:1 to (1) symptom relief with NSAIDs and a single injection of glucocorticoids and (waiting for spontaneous remission); (2) methotrexate and a single injection of glucocorticoids, and NSAIDs are optional; and (3) baricitinib and a single injection of glucocorticoids and NSAIDs are optional. During the observational follow-up period, patients are treated in shared decision with their rheumatologist. The primary outcome will be the change in DAS at 3 months. Secondary outcomes include radiographic progression, physical functioning, patient-reported outcomes, cost utilities, safety, progression to classifiable RA, and disease activity over time.</p><p><strong>Discussion: </strong>The 12-month I CEA trial studies early treatment of patients with UA with methotrexate, baricitinib, or NSAIDs. The study initially had a more complex design. Emerging safety warnings about baricitinib necessitated adjustment of the trial protocol including more extensive exclusion criteria. The number of included patients was lower than initially planned, supported by an updated sample size calculation.</p><p><strong>Trial registration: </strong>Dutch trial register NL73202.058.20, EudraCT 2019-004359-35, registered 10-06-2020. Protocol version 1Q, 06-05-2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"758"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11558825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142627939","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":"Effects of melatonin supplementation on metabolic parameters, oxidative stress, and inflammatory biomarkers in diabetic patients with chronic kidney disease: study protocol for a double-blind, randomized controlled trial.","authors":"Sara Sadeghi, Monir Sadat Hakemi, Fatemeh Pourrezagholie, Fatemeh Naeini, Hossein Imani, Hamed Mohammadi","doi":"10.1186/s13063-024-08584-x","DOIUrl":"10.1186/s13063-024-08584-x","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic kidney disease (CKD) is a pervasive disease of the current century that usually affects the adult population, especially people with diabetes and hypertension. According to the recent studies, inflammation, oxidative stress, apoptosis, and mitochondrial dysfunction are determining risk factors in the pathogenesis of CKD. Melatonin as a strong antioxidant is produced in various tissues including the kidneys. The present clinical trial aims to examine the efficacy of melatonin supplementation on metabolic parameters, oxidative stress, and inflammatory biomarkers in diabetic patients with CKD.</p><p><strong>Methods: </strong>This is a double-blind, randomized, placebo-controlled clinical study that will be investigated the impacts of melatonin supplementation in diabetic patients with CKD. Laboratory findings will be applied to diagnose diabetic CKD. Forty-eight eligible diabetic subjects with CKD will be selected and randomly assigned to receive 5 mg melatonin tablets or identical placebo twice daily for 10 weeks. Participants will be asked to remain on their usual diet and physical activity. The primary outcome of this study is changes in oxidative stress and inflammatory biomarkers. The secondary outcomes include changes in lipid profile, renal function indicators, fasting blood sugar and serum insulin, systolic and diastolic blood pressure (SBP and DBP), serum phosphorous concentration, sleep quality, body weight, body mass index (BMI), and waist circumference (WC). Statistical analysis will be conducted using the SPSS software (version 25).</p><p><strong>Discussion: </strong>We hypothesize that melatonin administration may be useful for treating diabetic CKD by modulating oxidative stress, inflammation, regulating lipid metabolism, and increasing insulin sensitivity through different mechanisms. The current trial will exhibit the effects of melatonin, whether negative or positive, on diabetic CKD status.</p><p><strong>Ethical aspects: </strong>The current trial received approval from Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.SHARIATI.REC.1402.072).</p><p><strong>Trial registration: </strong>This study had been registered in Iranian Registry of Clinical Trials.</p><p><strong>Registration number: </strong>IRCT20170202032367N9 on 11 August 2023. https://www.irct.ir/trial/70709 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"757"},"PeriodicalIF":2.0,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11559127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142629302","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}