Trials最新文献

{"title":"Guselkumab versus golimumab in patients with active psoriatic arthritis and inadequate response to an initial tumor necrosis factor inhibitor: study protocol for EVOLUTION, a pragmatic, phase 3b, open-label, randomized, controlled effectiveness trial.","authors":"Alexis Ogdie, Soumya M Reddy, Sarah H Gillespie, M Elaine Husni, Jose U Scher, Karen Salomon-Escoto, Jonathan Kay, Brent A Luedders, Jeffrey R Curtis, Alisa J Stephens Shields, Soumya D Chakravarty, Cinty Gong, Jessica A Walsh","doi":"10.1186/s13063-025-08777-y","DOIUrl":"10.1186/s13063-025-08777-y","url":null,"abstract":"<p><strong>Background: </strong>Psoriatic arthritis (PsA) is a multi-domain, inflammatory disease impacting joints, soft tissues, and skin; tumor necrosis factor inhibitors (TNFi) are typically the first biologic following inadequate response (IR) to conventional therapies. Although guidance is lacking on therapy selection after initial TNFi failure, data suggest TNFi-IR PsA patients may benefit from switching to a different mechanism of action (MOA) vs. cycling to another TNFi. Guselkumab is a fully human monoclonal antibody targeting the interleukin-23p19 subunit. Emphasizing practicality and applicability to routine clinical practice, EVOLUTION will pragmatically evaluate whether switching to guselkumab is more effective than cycling to a second TNFi (subcutaneous [SC] golimumab) in TNFi-IR PsA patients.</p><p><strong>Methods: </strong>The multicenter, longitudinal, prospective, observational Psoriatic Arthritis Research Consortium study guided eligibility criteria, outcome measures, and sample size estimates. Adults seen in clinical practice with active PsA (≥ 1 swollen joint) while receiving TNFi treatment will be eligible. Participants will be randomized (1:1:1) to guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at Week 0, Week 4, and Q8W; or SC golimumab 50 mg Q4W (no washout period). The novel primary composite endpoint is achievement of clinical Disease Activity in Psoriatic Arthritis (cDAPSA) low disease activity (≤ 13) and an Investigator's Global Assessment (IGA) of psoriasis score of 0/1 (scale: 0-4) at Month12. Secondary endpoints include cDAPSA + IGA 0/1 at Month 6; achievement of minimal disease activity, resolution of enthesitis and dactylitis (among patients affected at baseline) at Months 6/12; and mean changes at Months 6/12 in the 12-item PsA Impact of Disease, Dermatology Life Quality Index, Patient-Reported Outcomes Measurements Information System fatigue and depression questionnaires, and Bath Ankylosing Spondylitis Disease Activity Index (patients with physician-determined axial disease). The target sample size is 150 participants (50/treatment group); all analyses are considered exploratory.</p><p><strong>Discussion: </strong>EVOLUTION will employ a pragmatic approach, including a novel primary endpoint relevant to clinical practice, to assess whether switching to an alternate MOA biologic with guselkumab is more effective than cycling to a second TNFi among TNFi-IR PsA patients.</p><p><strong>Trial registration: </strong>This trial was registered at ClinicalTrials.gov, NCT05669833, on 3 January 2023, https://www.</p><p><strong>Clinicaltrials: </strong>gov/study/NCT05669833?term=%20NCT05669833&rank=1.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"96"},"PeriodicalIF":2.0,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11921613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143658810","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":"Non-invasive physical plasma for preventing radiation dermatitis in breast cancer: study protocol for a phase 3 randomised double-blind placebo-controlled trial (NIPP-RD III).","authors":"Cas Stefaan Dejonckheere, Julian Philipp Layer, Gustavo Renato Sarria, Shari Wiegreffe, Andrea Renate Glasmacher, Younèss Nour, Davide Scafa, Thomas Müdder, Teresa Anzböck, Frank Anton Giordano, Matthias Bernhard Stope, Leonard Christopher Schmeel, Eleni Gkika","doi":"10.1186/s13063-025-08806-w","DOIUrl":"10.1186/s13063-025-08806-w","url":null,"abstract":"<p><strong>Background: </strong>Radiation dermatitis (RD) is the most common side effect of breast irradiation, yet only few potent preventative and therapeutic options are available. Following encouraging results from a phase 1 and 2 trial on the topical use of non-invasive physical plasma (NIPP), a very well-tolerated physical treatment option to promote tissue regeneration generated from ambient air, we now present the study protocol for a planned phase 3 trial.</p><p><strong>Methods: </strong>In this randomised double-blind placebo-controlled trial, patients with breast cancer will be randomised (1:1) to receive either 120 s of NIPP or sham treatment with an identical device daily during hypofractionated breast irradiation following breast-conserving surgery. Standard skin care with urea lotion will be applied twice daily to the whole breast by all patients. Acute skin toxicity will be assessed weekly and includes clinician- (CTCAE v5.0) and patient-reported (modified RISRAS), and objective (spectrophotometry) assessments. The trial has started enrolment in the first quarter of 2024 and is projected to recruit 140 patients over 36 months.</p><p><strong>Discussion: </strong>This randomised controlled trial will recruit a homogeneous patient collective in terms of RD risk and aims to unequivocally establish the impact of NIPP on RD by employing a robust trial design, incorporating both the patient's perspective and validated objective outcome measures. If the addition of NIPP proves useful, it might reduce both physical and psychological distress caused by RD in numerous breast cancer patients and beyond.</p><p><strong>Trial registration: </strong>German Clinical Trial Registry DRKS00032560 (January 9th 2024).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"97"},"PeriodicalIF":2.0,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11921611/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664694","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":"Improving the capture and reporting of adverse events in clinical trials of non-pharmacological interventions: learnings from the PaCCSC/CST membership.","authors":"Rayan Saleh Moussa, Jack Power, Vanessa Yenson, Belinda Fazekas, Celia Marston, Annmarie Hosie, Layla Edwards, Domenica Disalvo, Linda Brown, Imelda Gilmore, John Stubbs, Andrea Cross, Sally Fielding, Meera R Agar","doi":"10.1186/s13063-025-08801-1","DOIUrl":"10.1186/s13063-025-08801-1","url":null,"abstract":"<p><strong>Background: </strong>Accurate capture and reporting of adverse events (AEs) in clinical trials is critical to understanding the potential harms of prospective interventions. Current AE-reporting frameworks are specifically constructed for pharmacological interventions and adaptation of these frameworks imparts the risk of excluding AEs unique to non-pharmacological interventions that have not yet been defined. As a result, clinical trials of non-pharmacological interventions seldom include a systematic method to capturing and reporting AEs, often using no method at all. These gaps make it likely that AEs in trials of non-pharmacological interventions are underreported, providing insufficient information about the safety of such interventions prior to their implementation in clinical practice. In addition, clinical trials focus primarily on participants receiving the intervention, with current AE-reporting frameworks not designed to capture potential harms to other personnel involved (i.e. family/carers, and clinical and research staff). A series of collaborative group discussions with consumers and interdisciplinary clinical trialists, and case study analyses were conducted to explore gaps in the capture and reporting of AEs specific to non-pharmacological trials, and their mitigation.</p><p><strong>Main body: </strong>Two case examples are provided. The first case example highlights that current methods are inadequate, resulting in inconsistencies in capturing AEs, influenced by the environmental context of the clinical trial. The second case example highlights the need for both systematic and simplified AE-reporting frameworks, particularly for clinical trials conducted in medically complex populations where participants may be at high risk of experiencing AEs. We recommend future trials of non-pharmacological interventions adopt a four-step framework that incorporates: (1) enhanced trial protocol development to define the participant, environmental context in which the intervention is taking place and identify other personnel involved; (2) pre-specify anticipated AEs in trial protocol; (3) selection of the most appropriate measurement system to define, report and grade AEs; and (4) develop corrective and preventative action plans.</p><p><strong>Conclusion: </strong>We provide recommendations for an AE-reporting framework for future trials that encompass risks unique to non-pharmacological interventions and all individuals involved. By focusing on these directions, we can streamline the process of capturing and reporting AEs and contribute to more impactful and sustainable outcomes.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"95"},"PeriodicalIF":2.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11921533/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143658799","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":"Circuit training intervention for cognitive function, gut microbiota, and aging control: study protocol for a longitudinal, open-label randomized controlled trial.","authors":"Keishi Soga, Michio Takahashi, Akari Uno, Takamitsu Sinada, Kentaro Oba, Keisei Kawashima, Yasuko Tatewaki, Taizen Nakase, Yasuyuki Taki","doi":"10.1186/s13063-025-08807-9","DOIUrl":"10.1186/s13063-025-08807-9","url":null,"abstract":"<p><strong>Background: </strong>Long-term exercise is increasingly considered an effective strategy to counteract cognitive decline associated with aging. Previous studies have indicated that circuit training exercises integrating aerobic and resistance modalities positively affect cognitive function. Furthermore, a growing body of evidence suggests that long-term exercise alters the gut microbiota, leading to an optimal environment for cognitive enhancement. Recent empirical evidence suggests that exercise plays a significant role in modulating aging-control factors at the protein level. Although the interaction between exercise and cognitive function is multifaceted, most studies have only examined a direct pathway from exercise to cognitive function. Therefore, this study aims to elucidate the effects of long-term circuit training on cognitive function through a comprehensive analysis of factors such as gut microbiota and proteins related to aging control.</p><p><strong>Methods: </strong>A total of fifty-one participants will be randomly assigned to either the circuit training or waitlist control group. The intervention group will participate in a circuit training program developed by Curves Japan Co., Ltd. two to three times weekly for 16 weeks. The control group will continue their usual daily routines without participating in any new active lifestyle program. The participants will undergo cognitive assessments at baseline and after the intervention. Fecal and blood samples for protein analysis will be collected before and after the intervention. The effect of exercise on cognition will be analyzed by comparing the measured outcomes before and after the intervention. The associations among these outcomes will be assessed using a linear mixed model and structural equation modeling approaches.</p><p><strong>Discussion: </strong>This study aims to provide the first insights into the comprehensive effects of exercise on cognitive function from the perspectives of gut microbiota and aging control. The findings are expected to contribute to improving brain health and combating age-related cognitive decline. Furthermore, the findings may help establish new guidelines for future studies on the relationship between exercise and cognitive function.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"94"},"PeriodicalIF":2.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11917102/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143658807","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":"Lack of reproducibility of trial sequential analyses: a meta-epidemiological study.","authors":"Xing Xing, Yining Wang, Yipeng Wang, Mohammad Hassan Murad, Lifeng Lin","doi":"10.1186/s13063-025-08799-6","DOIUrl":"10.1186/s13063-025-08799-6","url":null,"abstract":"<p><p>Systematic reviews and meta-analyses are essential tools for synthesizing evidence from multiple studies. Recently, trial sequential analyses (TSAs) have gained popularity as a component of meta-analyses, helping researchers dynamically monitor evidence as new studies are incorporated. This article introduces a meta-epidemiological study aimed at evaluating the reproducibility of TSAs within systematic reviews published in 2023. Two independent investigators assessed and reproduced the main TSA for each included systematic review. Our search in PubMed yielded a convenience sample of 98 systematic reviews. Only 28% (27/98) of the included TSAs provided sufficient data to calculate the required information size, an essential element for assessing statistical power and conducting TSAs. Among these, 81% (22/27) provided the necessary data to determine decision boundaries and Z-curves in TSAs. Overall, full reproducibility was achieved for only 13% (13/98) of TSAs. Specifically, for binary outcomes, 65% (47/72) of TSAs failed to report event rates in control groups, and 44% (32/72) did not report relative risk reductions. For continuous outcomes, 53% (17/32) failed to report minimally relevant differences, and 72% (23/32) did not report variances. These elements are crucial for TSA reproducibility. Moreover, the reproducibility of TSAs was associated with journal impact factors and adherence to the PRISMA guidelines. A collective effort is needed from systematic review authors, peer reviewers, and journal editors to improve the reproducibility of TSAs.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"93"},"PeriodicalIF":2.0,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11917100/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143658879","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":"Effectiveness of community-based intervention using PATCH on disease perception, empowerment, and self-care in hypertension: a community trial protocol.","authors":"Hassan Heydari, Roya Sadeghi, Ensiyeh Jamshidi, Abbas Rahimiforoushani, Hossein Ali Nikbakht, Mohammad Reza Adel Mashhadsari","doi":"10.1186/s13063-025-08743-8","DOIUrl":"10.1186/s13063-025-08743-8","url":null,"abstract":"<p><strong>Background: </strong>Hypertension plays a significant role in the global burden of cardiovascular diseases. The planned approach to community health (PATCH), as a community-based framework, highlights community participation in decision-making. This study aimed to determine the effectiveness of a community-based intervention using the PATCH on disease perception, empowerment, self-care behaviors, and blood pressure in patients with hypertension.</p><p><strong>Methods: </strong>This study will be a parallel randomized community trial. Twelve comprehensive rural health service centers (CRHSCs) are randomly selected as clusters. A total sample size of 428 individuals (214 in the intervention group and 214 in the control group) with hypertension covered by CRHSCs will be selected through cluster random sampling. The PATCH framework, developed by the Centers for Disease Control, will be employed to organize the community and empower it to address the issue in the intervention group. The control group will receive only the routine programs provided by the health system. Three months after the intervention, the outcome of hypertension perception will be assessed via the Disease Perception Questionnaire developed by Kamran et al., and empowerment will be measured via the Perceived Control Scale designed by Israel. Six months after the intervention, self-care behaviors will be evaluated through the Self-Care Behavior Assessment Questionnaire created by Han et al., and blood pressure will be assessed using a standard sphygmomanometer. Data analysis will be conducted via SPSS software version 20, which applies univariate and multivariate linear regression tests.</p><p><strong>Discussion: </strong>The protocol aligns with health policies in the domain of noncommunicable diseases, emphasizing sustainable and participatory approaches. If proven effective, the findings can be utilized in educational programs and policymaking efforts, paving the way for the broader implementation of community-based interventions. Moreover, this framework can empower social groups to take an active role in combating noncommunicable diseases, and if effective, its application could yield long-term health benefits for individuals and communities.</p><p><strong>Trial registration: </strong>Iranian Registry of Clinical Trials (IRCT), IRCT20231213060354N1. Registered on December 24, 2023. https://irct.behdasht.gov.ir/trial/74453.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"91"},"PeriodicalIF":2.0,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11912653/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143650627","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":"Efficacy and safety of PCA-assisted continuous paravertebral block in subacute herpes zoster-associated pain: study protocol for a randomized, controlled, double-blind superiority trial.","authors":"Bo Yang, Xiaohan Shi, Yanan Xu, Qing Wang, Zhaojun Meng, Lin Lv, Jin Xu, Jing Qi, Yan Lu, Hailong Dong, Nan Gu","doi":"10.1186/s13063-025-08798-7","DOIUrl":"10.1186/s13063-025-08798-7","url":null,"abstract":"<p><strong>Background: </strong>Pain management for herpes zoster-associated pain (ZAP) is essential to improve patients' daily lives and potentially intervene in the chronicity. Long-lasting, repetitive painful stimuli might lead to central sensitization and neuropathic pain generation. The subacute phase is the main period for ZAP patients to seek medical attention, and it is also a critical treatment time window for the transformation of ZAP to chronic pathological changes. Although there is still a lack of rigorous considerable sample evidence, the pain degree of ZAP and the incidence of postherpetic neuralgia (PHN) may decrease accordingly with increasing adequate analgesia. Compared to repeated paravertebral nerve block (PVB), patient-controlled analgesia (PCA)-assisted continuous PVB provides more prolonged and comprehensive pain relief according to patient needs. Given this, we intend to test the hypothesis that PCA-assisted continuous PVB delivers a safe and better analgesic effect and reduces PHN incidence in subacute ZAP patients.</p><p><strong>Methods: </strong>A total of 82 eligible subacute herpes zoster (SHZ) patients will be recruited and randomly assigned to the PCA-assisted continuous PVB group (Group PCA) and the repeated PVB group (Group rPVB) at a 1:1 ratio. All enrolled patients will undergo thoracic paravertebral space (TPVS) catheterization and receive similar doses of medication for 7 days. The main intervention factor lies in the different drug administration manners. PCA-assisted continuous PVB treatment will be achieved by pumping, while repeated PVB treatment will be conducted by injecting other therapeutic solutions. The participants and investigators will be both blinded to group allocation. The primary outcome is the VAS scores 1 month after treatment. The secondary outcomes include the incidence of PHN and the adverse events during treatment and follow-up.</p><p><strong>Discussion: </strong>The results from this study will provide clinical evidence on the efficacy and safety of PCA-assisted continuous PVB for subacute ZAP patients.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2300068158. Registered on 9 February 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"92"},"PeriodicalIF":2.0,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11912600/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143650693","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":"Reduced anticoagulation targets in extracorporeal life support (RATE): protocol for a pre-planned secondary Bayesian analysis of the rate trial.","authors":"Olivier van Minnen, Maximilian Linde, Annemieke Oude Lansink-Hartgring, Bas van den Boogaard, Jeroen J H Bunge, Thijs S R Delnoij, Carlos V Elzo Kraemer, Marijn Kuijpers, Jacinta J Maas, Jesse de Metz, Marcel van de Poll, Dinis Dos Reis Miranda, Alexander P J Vlaar, Don van Ravenzwaaij, Walter M van den Bergh","doi":"10.1186/s13063-025-08737-6","DOIUrl":"10.1186/s13063-025-08737-6","url":null,"abstract":"<p><strong>Background: </strong>The RATE trial is a three-arm non-inferiority randomized controlled trial in adult patients treated with extracorporeal membrane oxygenation (ECMO) on the effect of anticoagulation levels on mortality, hemorrhagic, and thrombotic complications. The current protocol presents the rationale and analysis plan for evaluating the primary and secondary outcomes under the Bayesian framework.</p><p><strong>Methods: </strong>This protocol was drafted and submitted before study completion and, thus, the primary analysis. The primary outcome of the Bayesian analysis is mortality at 6 months. The secondary outcomes are severe hemorrhagic and thrombotic complications. We will use an uninformative prior for the primary analysis. Sensitivity analyses will be performed using a skeptical prior and an evidence-based informative prior.</p><p><strong>Conclusion: </strong>The proposed secondary, pre-planned Bayesian analysis of the RATE trial will provide additional information on the effect of different anticoagulation strategies during ECMO on complication rates. This additional Bayesian analysis will likely increase the validity of our results and complement the interpretation of the primary and several secondary outcomes.</p><p><strong>Trial registration: </strong>This trial is registered at https://clinicaltrials.gov/ (NCT04536272), registration date September 2, 2020. This trial is also registered at the Dutch trial register (NL7976).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"90"},"PeriodicalIF":2.0,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11909967/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143634834","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":"Empowerment and mobile technology in the detection and treatment of main cardiovascular risk factors of patients with ischemic stroke or transient ischemic attack: a protocol for a multicenter randomized controlled trial (CARDIOSTROKE).","authors":"T Lumikari, J Putaala, J Pirinen, A Kerola, G Sibolt, Hanna Granroth-Wilding, S Pakarinen, M Lehto, T Nieminen","doi":"10.1186/s13063-025-08778-x","DOIUrl":"10.1186/s13063-025-08778-x","url":null,"abstract":"<p><strong>Background: </strong>Hypertension and atrial fibrillation (AF) are major treatable risk factors for ischemic stroke and transient ischemic attack (TIA). However, most of the patients with an ischemic stroke or TIA fail to reach desired blood pressure (BP) control and AF remains underdiagnosed with standard ECG monitoring. The aim of the CARDIOSTROKE study is to (1) test the effect of 3-week non-invasive ECG monitoring combined with (2) self-monitoring of BP and (3) patient-controlled titration of antihypertensives over 12 months in patients with recent non-cardioembolic ischemic stroke or TIA.</p><p><strong>Methods: </strong>CARDIOSTROKE is an investigator-initiated, multicenter, open, prospective trial aiming to randomize patients with recent (within 1 month) ischemic stroke or TIA to receive in a 2:1 fashion either (1) standard diagnostic work-up and follow-up (control arm) or (2) 3-week ECG monitoring combined with self-monitoring of BP and mobile-device-assisted self-titration of antihypertensives (intervention arm). The co-primary outcomes are (1) mean reduction in systolic BP and (2) detection of new AF at 12 months.</p><p><strong>Discussion: </strong>Mobile technology assisted control of the two major risk factors of stroke recurrence has not previously been studied in patients with recent stroke or TIA, which supports conducting a randomized trial in this patient population.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03710902. Registered on October 16, 2018.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"89"},"PeriodicalIF":2.0,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11907936/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626130","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":"Standard versus Pre-emptive Antibiotic Treatment to Reduce the Rate of Infectious Outcomes after Whipple resection (SPARROW): a study protocol for a multicentre, open-label, randomised controlled trial.","authors":"D H M Droogh, M G J de Boer, J van Prehn, H Putter, B A Bonsing, K Bosscha, S A W Bouwense, J P B M Braak, F J H Hoogwater, D J Lips, M D P Luyer, M W J Stommel, J H Wijsman, M G Besselink, H C van Santvoort, B Groot Koerkamp, A L Vahrmeijer, J S D Mieog","doi":"10.1186/s13063-024-08574-z","DOIUrl":"10.1186/s13063-024-08574-z","url":null,"abstract":"<p><strong>Background: </strong>Consensus and evidence on the impact of pre-emptive antibiotic treatment after pancreatoduodenectomy is lacking, which is reflected by contradictory recommendations in (inter)national guidelines and current clinical practice. Pre-emptive antibiotic treatment may reduce the risk of abdominal surgical site infections in patients with a high risk of contaminated bile undergoing pancreatoduodenectomy. This pertains mostly patients with preoperative biliary drainage or an ampullary malignancy. The SPARROW trial will evaluate the effect of pre-emptive antibiotic treatment in patients with preoperative biliary drainage or an ampullary malignancy undergoing pancreatoduodenectomy.</p><p><strong>Methods: </strong>The SPARROW trial is a multicentre, open-label, randomised controlled trial evaluating the effect of pre-emptive antibiotic treatment in patients with a high risk of contaminated bile undergoing pancreatoduodenectomy. A total of 366 evaluable patients will be included in twelve centres in the Netherlands. Patients will be randomly allocated to either the perioperative antibiotic prophylaxis and pre-emptive antibiotic treatment (intervention) arm and the perioperative antibiotic prophylaxis (control) arm. In both study arms, the perioperative antibiotic prophylaxis consists of cefazolin, metronidazole and a single-dose of gentamicin, which is discontinued after surgery. In the pre-emptive antibiotic treatment arm, an additional antibiotic course of 5 days of cefuroxime and metronidazole is started postoperatively. The primary outcome is a clinically relevant organ/space surgical site infection (OSI) up to 90 days after surgery. Secondary outcomes include other clinically relevant complications (such as isolated OSI, superficial incisional surgical site infections, postoperative pancreatic fistula, ICU admission, readmission, and in-hospital and 90-day mortality), use of therapeutic antibiotics, and concordance between perioperative obtained bile cultures and cultures obtained from infectious complications.</p><p><strong>Discussion: </strong>The SPARROW trial will provide evidence on the effect of pre-emptive antibiotic treatment in patients with a high risk of contaminated bile undergoing pancreatoduodenectomy to provide recommendations for an improved and standardised antimicrobial policy.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT0578431. Registered on March 23, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"88"},"PeriodicalIF":2.0,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11908089/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143626148","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}