Trials最新文献

{"title":"The effect of repetitive transcranial magnetic stimulation (rTMS) on perioperative neurocognitive disorders in patients after cardiac surgery: study protocol for a randomized controlled trial.","authors":"Jing Wang, Xuyang Wang, Sijie Li, Jinrong Yang, Xiang Yan, Jie Gao, Xiuqin Jia, Long Zuo, Anshi Wu, Changwei Wei","doi":"10.1186/s13063-025-08988-3","DOIUrl":"10.1186/s13063-025-08988-3","url":null,"abstract":"<p><strong>Introduction: </strong>Perioperative neurocognitive disorders (PND) is one of the most common postoperative complications among elderly patients (above 65 years old) undergoing cardiac surgery. However, thus far, there have not been any effective therapies for managing PND. Recent research has shown that repetitive transcranial magnetic stimulation (rTMS) alters brain plasticity and improves cognitive function in several neurodegenerative disorders and psychiatric disorders. However, the potential benefits of rTMS in reducing PND in patients undergoing cardiac surgery have not been investigated. Therefore, the current protocol is designed to determine whether rTMS can reduce the incidence of PND in patients undergoing cardiac surgery.</p><p><strong>Methods and analysis: </strong>The study will be a single-blinded, randomized controlled trial. Participants undergoing elective cardiac surgery will be randomized to receive either rTMS or sham stimulation with focal figure-of-eight coils over the right dorsolateral prefrontal cortex. A series of neuropsychological tests will be completed to evaluate cognitive function in surgery patients before, on day 7, and on day 30 after cardiac surgery. The primary outcome is the prevalence of PND in cardiac surgery patients. The secondary outcomes will be the incidence of postoperative delirium, pain, sleep quality, depressive symptoms, activities of daily living, length of hospital stay and ICU length of stay, and rate of complication and mortality during the hospital stay.</p><p><strong>Ethics and dissemination: </strong>Beijing Chaoyang Hospital Ethics Committee approved this study and has the number 2022-ke-487. It is registered with Clinical Trials (trial number NCT05668559). Informed consent must be provided by all participants. The study result will be published in a peer-reviewed journal.</p><p><strong>Trial registration: </strong>NCT05668559. Registered on June 6, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"253"},"PeriodicalIF":2.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12291346/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144708993","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":"Blended therapy for adolescents with chronic health conditions to increase fatigue-related self-efficacy (Booster): protocol for a single-case multiple baseline study.","authors":"Maartje D Stutvoet, Anouk Vroegindeweij, Jan Houtveen, Raphaële R L van Litsenburg, Elise van de Putte, Remco C Veltkamp, Sanne L Nijhof","doi":"10.1186/s13063-025-08960-1","DOIUrl":"10.1186/s13063-025-08960-1","url":null,"abstract":"<p><strong>Background: </strong>Fatigue is a common symptom in adolescents with a chronic health condition. Persistent fatigue and its impairments may be prevented by early intervention with Booster. Booster is a transdiagnostic blended care intervention that aims to increase fatigue-related self-efficacy (FSE). Through experience sampling methodology (ESM) via the Booster smartphone app, Booster helps users gain personalised insight into the relationship between their thoughts, feelings, activities, and fatigue. Based on this insight and shared-decision making, the participant and executive investigator set personal lifestyle goals, such as more exercise and fewer daytime naps. The previous version of Booster, PROfeel, has already been shown effective in treating persistent fatigue in youth. Booster's value as an early intervention has yet to be studied. To better suit this aim and align with user preferences, the new Booster app includes features like goal attainment assistance, daily outcome tracking, and motivating game mechanics (e.g., rewards and a minigame). This protocol describes a study to examine the effect of Booster on FSE and the other study outcomes fatigue, school participation, life satisfaction, and perceived health. The secondary aim is to explore individual differences regarding (moment of) changes in outcomes during the Booster intervention.</p><p><strong>Methods: </strong>It is a single-centre study with a multiple baseline single-case experimental design (SCED). We aim to include twenty adolescents ages 12 to 18 years with a chronic health condition and fatigue. Booster's effect on outcomes will be measured with a daily survey during Phase A (baseline) and B (intervention). The start of phase B will be randomised across cases. The effect will be assessed with the multiple baseline single-case randomisation test (SCRT) at the group level. Additionally, at the single-case level, we will explore change using permutation distancing tests (PDTs), single-case interrupted time series analysis (ITSA), and change point analyses. Also, we will assess participant characteristics associated with (long-term) improvements.</p><p><strong>Discussion: </strong>Booster uses innovative methods by combining tailored ESM-insight, mHealth and healthcare professional support. Group-level analysis, strengthened by single-case observational analyses, will evaluate the effectiveness of ESM-supported blended care as an early fatigue intervention and identify its potential working mechanisms. It lays the groundwork for implementing ESM tools in clinical practice.</p><p><strong>Trial registration: </strong>ClinicalTrials, NCT06562335. Registered on 24 July 2024, https://clinicaltrials.gov/study/NCT06562335 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"255"},"PeriodicalIF":2.0,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12291284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144709013","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":"PRALINE: study protocol for a phase IIb inpatient stroke rehabilitation randomized controlled trial investigating longitudinal outcomes after progressive abduction loading therapy.","authors":"Heidi R Roth, Carolina Carmona, Gina Clark, Jane E Gyarmaty, Julius P A Dewald, Elise Giblin, Richard L Harvey, Jacquelyn Jaskiewicz, Kwang-Youn A Kim, Nicola Lancki, Alexis Luhrsen, Ahalya Mandana, Deepali Manikonda, Andrew Morris, Sonia Sheth, Mary Ellen Stoykov, Amanda C Young, Donna Zielke, Michael D Ellis","doi":"10.1186/s13063-025-08969-6","DOIUrl":"10.1186/s13063-025-08969-6","url":null,"abstract":"<p><strong>Background: </strong>Stroke is the leading cause of long-term disability with paucity of evidence-based interventions for individuals with severe upper extremity impairment in the affected arm. Loss of independent joint control limits reaching distance and velocity contributing to activity and participation limitations. Emerging evidence demonstrates improved independent upper extremity joint movement with training combining shoulder abduction loading during high repetition, task-specific reaching practice. The purpose of this study is to compare outcomes for one-year post-stroke for participants who receive reaching training with vs without progressive shoulder abduction loading during upper extremity reaching training using a standardized mechantronic device.</p><p><strong>Methods: </strong>This is a phase II, double-blinded randomized clinical trial conducted at two inpatient rehabilitation hospitals. Eighty-six individuals will be recruited upon admission to acute inpatient rehabilitation and randomly allocated to either the experimental or active comparator intervention groups. Both groups will receive reaching training with the affected upper extremity in a standardized mechatronic device 4 days per week while in inpatient or day rehabilitation. Outcomes will be assessed at baseline, weekly while in inpatient and day rehabilitation, and every other month after discharge until one year post-stroke. Primary outcomes include change in reaching function of the affected upper extremity, measured by kinematic evaluation. This captures the loss of independent joint control due to flexion synergy expression. Secondary outcomes include measures of severity of flexion synergy motor impairment, Action Research Arm Test, Fugl-Meyer Assessment, and the Stroke Impact Scale.</p><p><strong>Discussion: </strong>This study will test the efficacy of progressive shoulder abduction loading during reaching training using a mechatronic device. The results of this study have the potential to inform clinical practice for upper extremity reaching training for individuals with severe upper extremity impairment post-stroke to reduce flexion synergy expression.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov, NCT04118998. Registered on 8 October 2019.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"250"},"PeriodicalIF":2.0,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12278522/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144675870","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":"Exploring the associations between intraoperative electroencephalographic depression mediated by different anaesthetic drugs and negative postoperative behavioural changes in children undergoing day surgery: a protocol for a two-centre randomised clinical trial.","authors":"Fei Sun, Fangming Shen, Weiwei Cai, Zhenqiang Si, Zhen Hu, Lu Liu, Jie Sun, Li Zhang","doi":"10.1186/s13063-025-08962-z","DOIUrl":"10.1186/s13063-025-08962-z","url":null,"abstract":"<p><strong>Background: </strong>Negative postoperative behavioural changes (NPOBCs) are among the most common complications of paediatric anaesthesia. The association between electroencephalogram (EEG) suppression and postoperative outcomes in previous clinical studies has been limited to delirium occurring early in the anaesthesia recovery room, and there are no reports of associations with negative postoperative behavioural changes in the distant postoperative period. However, this has important implications for children undergoing day surgery who are discharged on the same day after surgery.</p><p><strong>Methods: </strong>The objective of this study is to investigate the mediating effects of intraoperative EEG patterns and negative postoperative behavioural changes in children undergoing paediatric day surgery. This study is a two-centre, prospective, randomised, single-blind, controlled trial involving 854 paediatric patients undergoing day surgery at the Children's Hospital of Nanjing Medical University and Zhongda Hospital of Southeast University; these patients are randomly assigned into two groups: the propofol intravenous anaesthesia, which is induced and maintained with propofol, group (Group T) and the sevoflurane inhalation anaesthesia, which is induced and maintained with sevoflurane, group (Group S). The depth of anaesthesia is monitored for both groups of children, and the EEG characteristics of the children are extracted. The primary outcome measure is the incidence of negative behavioural changes during the first three days after surgery. The secondary outcomes include evaluating the incidence of negative behavioural changes at 1, 7, and 28 days postoperatively and investigating the relationship between intraoperative EEG patterns and NPOBCs. The study flow diagram is presented in Fig. 1.</p><p><strong>Discussion: </strong>The aim of this clinical trial is to prospectively observe the mediating effects of intraoperative EEG forms and negative postoperative behavioural changes in children undergoing paediatric day surgery and to further explore the possible mechanisms of negative postoperative behavioural changes in paediatric anaesthesia. Moreover, in paediatric day surgery, the postoperative discharge assessment of children still lacks the ability to predict negative postoperative behavioural changes, and this study will construct a prediction model of negative postoperative behavioural changes to help anaesthesiologists more comprehensively assess whether children meet the criteria for discharge and to improve the quality of postoperative rehabilitation of children.</p><p><strong>Trial registration: </strong>The study protocol was registered with the China Clinical Trial Registry ( http://www.chictr.org.cn ) on 1 July 2024 under the registration number ChiCTR2400086403. This trial is retrospectively registered.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"252"},"PeriodicalIF":2.0,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12278671/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144675869","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":"Comparison of telemedicine-assisted psychotherapy, exercise therapy, or a combination of both in patients with post-COVID-19 syndrome (TelPoCo): study protocol for a randomized controlled trial.","authors":"Sebastian Beyer, Mariel Nöhre, Isabell Pink, Sebastian Häckl, Nele Henrike Thomas, Frank Klawonn, Uwe Tegtbur, Martina de Zwaan, Sven Haufe","doi":"10.1186/s13063-025-08968-7","DOIUrl":"10.1186/s13063-025-08968-7","url":null,"abstract":"<p><strong>Background: </strong>Post-COVID-19 syndrome (PCS) presents in a multitude of ways, with fatigue, physical constraints, and diminished quality of life being common symptoms. It is becoming increasingly clear that unimodal behavioral interventions do benefit all PCS patients. Adherence to and response to isolated psychotherapy or physical activity interventions vary greatly, with certain patients benefit more from one form of therapy, or even a combination, than others do. The study aims to compare the effects of a single exercise therapy, psychotherapy, and a combination of both therapies.</p><p><strong>Methods: </strong>The study will be conducted as a prospective, randomized controlled, open-label trial with 3 treatment arms (exercise therapy, psychotherapy, and combined therapy). According to the sample size calculation, 65 participants will be enrolled in each group. The primary outcome is the change of PCS fatigue symptoms from baseline to 3 months, estimated by the Fatigue Assessment Scale. Secondary endpoints include changes in further measures of fatigue (Chalder Fatigue Skala, Multidimensional Fatigue Inventory, Post-exertional Malaise Scale, Bell Scale), health-related quality of life (Short Form-36 and Brief Illness Perception Questionnaire), anxiety and depression (Hospital Anxiety and Depression Scale), and work ability (Work Ability Index). The intervention lasts for 3 months and includes online therapy sessions of 50 min every 2 weeks or in case of lack of concentration or fatigue this could be split to two 25-min sessions (all equating to a total of 300 min of specialist care). The psychotherapy adopts a short-term and coping-oriented approach based on the unique requirements of each patient from a psychotherapeutic perspective. Exercise therapy involves a personalized physical activity plan customized to suit the patient's requirements, with tracking day-to-day physical activity along with daily moderate endurance and strengthening workouts. An ANCOVA model, including the stratification factors sex and BMI, will be used for the primary analysis of Fatigue Assessment Scale. Significance tests will be based on the group differences in least square means and corresponding 95% CIs.</p><p><strong>Discussion: </strong>Due to the current relevance of the issue, the unclear evidence so far, and the lack of appropriately powered randomized studies, it is crucial to assess potentially effective concepts for treating patients with PCS. Future therapy decisions will benefit from answering the question of whether combined therapies hold a significant advantage over unimodal therapeutic approaches, as well as identifying predictors that indicate an advantage of certain therapies for particular patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06042751 . Registered on 21 September 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"251"},"PeriodicalIF":2.0,"publicationDate":"2025-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12278562/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144675868","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":"Implementing a new model of primary care for stroke survivors living in the community: a mixed-methods process evaluation.","authors":"Maria Raisa Jessica Aquino, Grace Turner, Elizabeth Kreit, Emily G Blatchford, Julie Grant, Vicki Johnson, Ricky Mullis, Jonathan Mant","doi":"10.1186/s13063-025-08957-w","DOIUrl":"10.1186/s13063-025-08957-w","url":null,"abstract":"<p><strong>Background: </strong>Survival after stroke is improving, leading to increased demand on primary care and community services to meet the long-term care needs of people living with stroke. Improving Primary Care After Stroke (IPCAS) is a novel model of primary care for stroke survivors living in the community. IPCAS was a complex intervention, with intervention components aimed at stroke survivors and healthcare professionals. This process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention.</p><p><strong>Methods: </strong>The process evaluation was underpinned by the National Institute of Health's Behaviour Change Consortium fidelity framework. A mixed methods design was used to assess fidelity of design, training, delivery and engagement. Methods included questionnaires, video- and audio-recordings, observations, and interviews with staff and participants.</p><p><strong>Results: </strong>The IPCAS intervention reflected its theoretical underpinnings and was substantially different from usual care. Most components of the intervention were delivered with high or moderate fidelity and training fidelity was high. In particular, the checklist was considered useful. However, other components were less valued, in particular, the direct point of contact service which was hardly used by participants and the local directory of services which had variable take up by healthcare professionals. It was not possible to facilitate communication between primary and secondary care as originally planned. Furthermore, some practices used a GP or healthcare assistant to deliver the reviews, rather than a practice nurse as planned. Several participants did not feel the intervention was relevant for them due to their recovery and the time that had passed since their stroke.</p><p><strong>Conclusions: </strong>This mixed-methods process evaluation provided novel insights into the design, delivery and engagement with a new model of primary care for stroke survivors. Despite high or moderate fidelity for delivery of most components of the intervention and high training fidelity, some components, such as the direct point of contact, were not valued and several participants did not feel the intervention was relevant for them.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03353519. Registered on November 27, 2017.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"249"},"PeriodicalIF":2.0,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12276669/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144668604","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":"REVERSE model: a novel approach in medical research.","authors":"Luca Saba, Gianluca De Rubeis, Francesco Pisu","doi":"10.1186/s13063-025-08974-9","DOIUrl":"10.1186/s13063-025-08974-9","url":null,"abstract":"<p><strong>Background: </strong>Randomized controlled trials are considered the gold standard but they are limited by high costs and external validity. The REVERSE model is introduced to address these challenges.</p><p><strong>Methods: </strong>The REVERSE model encompasses two sequential phases. First, in the data mining phase, compatible datasets are identified and merged by using matching or stricter inclusion/exclusion criteria, thereby reducing selection bias. Second, a randomization phase addresses the inherent biases of the selected datasets. For a dichotomous scenario, the data are organized into four sub-cohorts according to the concordance with the original and new assignments: two concordant and two non-concordant. New decision factors are tested in concordant groups. Patients in non-concordant cohorts were excluded. ROMICAT-II was used to reproduce the findings from both the ROMICAT-II and ROMICAT-I trials, with results reported as the median of 10,000 applications.</p><p><strong>Findings: </strong>The REVERSE model successfully replicated the results of ROMICAT-II and ROMICAT-I using only ROMICAT-II data. For ROMICAT-II, the median (interquartile range) of all median differences between length of hospitalization stay with cardiac computed tomography angiography (CCTA) and standard diagnostic strategy after 10,000 applications matched the trial's findings 100% of the time (18.06 h [17.76-18.32] vs. 18.1 h; p < 0.05). For ROMICAT-I, median of all REVERSE plaque prevalence (PP) at CCTA matched the observed PP at CCTA from ROMICAT-I (49.63% [48.2-51.2] vs. 49.7%). The REVERSE PP fell within 49.63% ± 5% in 9733 (97.33%) applications.</p><p><strong>Conclusion: </strong>The REVERSE model allows repurposing existing datasets to explore novel research questions while mitigating inherent biases through stringent inclusion criteria matching and randomization.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"248"},"PeriodicalIF":2.0,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12275234/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144668605","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 recombinant human granulocyte colony-stimulating factor in patients with unexplained recurrent pregnancy loss: a protocol for a multicenter, randomized, double-blind, controlled trial.","authors":"Fangxiang Mu, Zhuhua Cai, Lirong Du, Xianghui Zeng, Qi Zhou, Yaolong Chen, Fang Wang","doi":"10.1186/s13063-025-08951-2","DOIUrl":"10.1186/s13063-025-08951-2","url":null,"abstract":"<p><strong>Background: </strong>Unexplained recurrent pregnancy loss (uRPL), defined as the loss of two or more pregnancies without an identified cause, affects approximately 1-2% of women trying to conceive. Emerging evidence suggests that an imbalance in maternal-fetal immunological tolerance may play a key role in its pathogenesis. Granulocyte colony-stimulating factor (G-CSF), a glycosylated polypeptide chain cell growth factor, has shown promise in improving pregnancy outcomes in uRPL, although findings from previous clinical trials are inconsistent. High-quality, adequately powered studies are urgently needed to determine its clinical utility. This study aims to evaluate the efficacy and safety of G-CSF in Chinese women with uRPL, providing a more theoretical basis for clinical practice.</p><p><strong>Methods: </strong>A randomized, double-blind, placebo-controlled, multicenter clinical trial will enroll 528 eligible participants, assigned to test group (n = 264, G-CSF 150 μg, subcutaneously every other day) and control group (n = 264, placebo), starting after confirmation of early pregnancy and ending at 10 weeks + 0 days of gestation. All participants will also receive dydrogesterone and aspirin as supportive care. The primary endpoint is fetal survival to 24 weeks, and secondary endpoints are early pregnancy loss, clinically confirmed pregnancy, ongoing pregnancy, fetal survival to 28 weeks, ectopic pregnancy, preterm birth, stillbirth, and pregnancy complications (preeclampsia, gestational diabetes mellitus, HELLP syndrome, placental abruption). The trial will also explore subgroup effects based on research centers (4 centers), age, number of pregnancy losses, and body mass index.</p><p><strong>Discussion: </strong>This trial aims to provide high-quality evidence on the efficacy and safety of G-CSF in the treatment of uRPL, particularly in the Chinese population where existing data are limited. The findings may support evidence-based recommendations and inform treatment decisions in a population where therapeutic options remain limited and controversial.</p><p><strong>Trial registration: </strong>ChiCTR2300077436. Prospectively registered on 2023-11-08.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"245"},"PeriodicalIF":2.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12257775/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144638173","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":"Clinical trials with interim analyses: standardizing terminology to increase clarity.","authors":"Elina Asikanius, Benjamin Hofner, Lisa V Hampson, Gernot Wassmer, Christopher Jennison, Tobias Mielke, Cornelia Ursula Kunz, Kaspar Rufibach","doi":"10.1186/s13063-025-08942-3","DOIUrl":"10.1186/s13063-025-08942-3","url":null,"abstract":"<p><p>Interim analyses for group-sequential decision-making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. Still, confusions and uncertainties on aspects of how to operationalize and interpret interim analyses exist for many stakeholders. In this paper, a team of statisticians from the pharmaceutical industry, academia, and regulatory agencies provide a multi-stakeholder perspective on the key concepts behind interim analyses, with the aim to introduce standard terminology to mitigate misunderstandings and facilitate clearer discussions.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"247"},"PeriodicalIF":2.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12261654/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144638171","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 SGLT2 inhibitors on cardiac autonomic activity and ventricular remodeling in patients with acute myocardial infarction: study protocol for a clinical trial.","authors":"Jun Wan, Qinglong Zhang, Feng Xu, Xin Jiang, Cai Chen, Xiaodong Pan, Jinglin Cheng, He Li","doi":"10.1186/s13063-025-08956-x","DOIUrl":"10.1186/s13063-025-08956-x","url":null,"abstract":"<p><strong>Background: </strong>Sodium-glucose co-transporter 2 inhibitors (SGLT2-I) exhibit significant cardiovascular protective effects in patients with acute myocardial infarction (AMI) complicated with type 2 diabetes mellitus (T2DM), mainly through enhancing cardiac function and reducing malignant arrhythmias. However, limited evidence exists regarding their efficacy in non-diabetic AMI patients. Moreover, the relationship between these benefits and improvements in cardiac autonomic function and left ventricular remodeling remains contentious, hindering a comprehensive understanding of their mechanisms of action. This study aims to fill this knowledge gap regarding dapagliflozin's effects on cardiac autonomic activity and ventricular remodeling in AMI patients.</p><p><strong>Methods: </strong>This study is a prospective, randomized, open-label, assessor-blinded, single-center trial in AMI patients in China. A total of 110 participants will be randomly allocated in a 1:1 ratio to either receive standardized treatment alone or receive standardized treatment along with 10 mg of dapagliflozin taken once daily. The primary endpoint is the change from the baseline to 24 weeks in heart rate variability (HRV) and deceleration capacity (DC) measured by 24-h ambulatory Holter monitoring. Secondary endpoints include changes in the left ventricular remodeling index (a relative change of LV end-diastolic volume, LVRI) as measured from baseline, along with the incidence of major adverse cardiovascular events throughout the follow-up period. Changes in various variables from the baseline will also be analyzed, encompassing glucose and lipid levels, blood pressure, body weight, and biomarkers linked to diagnostic and functional parameters of AMI, such as creatine kinase, troponin I (TnI) level, and N terminal pro B type natriuretic peptide (NT-proBNP) level.</p><p><strong>Discussion: </strong>This will be the first trial to evaluate the effects of dapagliflozin on cardiac autonomic function and ventricular remodeling in AMI patients. This study seeks to elucidate the mechanisms underlying dapagliflozin's cardioprotective effects, potentially informing future therapeutic strategies for improving outcomes in this population.</p><p><strong>Trial registration: </strong>Clinical trial ID: ChiCTR2400084050. Registration date: May 9, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"246"},"PeriodicalIF":2.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12257681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144638172","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}