Trials最新文献

{"title":"\"SPHERE\" multi-component novel psychosocial intervention for people with HIV: study protocol for a randomised controlled trial.","authors":"Vasiliki Papageorgiou, Fiona C Lampe, Janey Sewell, Colette J Smith, Andrew Briggs, Ryan Ottridge, Vanessa Apea, Michael Brady, Suzanne Lockyer, David Asboe, Gabriel Schembri, Eileen Nixon, Charlie Hughes, Claire Ryan, Megan Jenkins, Shrushma Loi, Alex Sparrowhawk, Rebecca Woolley, Versha Cheed, Natalie Ives, Serena Dhir, Simon Jones, Lorraine Sherr, Marc Lipman, Andrew N Phillips, Richard Harding, Fiona Burns, Carl May, Alison J Rodger","doi":"10.1186/s13063-025-08904-9","DOIUrl":"10.1186/s13063-025-08904-9","url":null,"abstract":"<p><strong>Background: </strong>Antiretroviral therapy (ART) has transformed HIV into a manageable health condition with normal life expectancy. However, people with HIV continue to have poorer mental health compared to background populations, which may be linked to stigma, lack of social support, or socioeconomic challenges. Personalised care aims to improve the outcomes of people with long-term health conditions and the National Health Service (NHS) Long Term Plan looks to implement this (including access to health coaching and social prescribing). The SPHERE trial aims to assess whether a health and well-being coaching and social prescribing intervention improves patient-reported health and well-being among people living with HIV who have psychosocial needs.</p><p><strong>Methods: </strong>SPHERE will be conducted across seven HIV outpatient clinics in England and is a pragmatic, two-arm, parallel group randomised controlled trial (RCT) embedding a routine assessment of psychosocial needs in HIV care. Eligibility criteria are people living with HIV aged 18 or older, available for the duration of study follow-up and scoring 16 or more on an assessment of psychosocial need: \"Positive-Outcomes-11\" (PO-11), covering physical, psychological, social and socioeconomic aspects of health and well-being. The RCT requires 568 participants who will be individually randomised in a 1:1 ratio to either a health and well-being coaching and social prescribing intervention or usual care. The intervention consists of up to eight coaching sessions that will be delivered by health professionals (e.g. HIV nurses) who have received specialist training to become health and well-being coaches. The trial will also include an internal pilot phase, process evaluation (to evaluate intervention feasibility, acceptability and mechanisms of action), economic evaluation (to assess the cost-effectiveness of the intervention and impact on NHS resource use) and parallel observational study (to assess subsequent development of psychosocial needs among those not initially eligible for the trial). The primary outcome is defined as achieving a reduction in PO-11 score of at least 40% from baseline to 6 months post-randomisation. Secondary outcomes include symptoms of depression and anxiety, social support, self-stigma, coping self-efficacy, resilience, lifestyle factors and health-related quality of life.</p><p><strong>Discussion: </strong>The SPHERE trial will evaluate the effectiveness and cost-effectiveness of implementing psychosocial health and well-being coaching in a secondary HIV care setting. If effective, this model of personalised care could be transferable to other long-term health conditions.</p><p><strong>Trial registration: </strong>International Standard Randomised Controlled Trials Number (ISRCTN) Registry: ISRCTN47187932 [registered 12 July 2024].</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"337"},"PeriodicalIF":2.0,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406414/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970692","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":"BodyBalance as an exercise therapy for knee osteoarthritis in older women: a study protocol for a randomized controlled trial.","authors":"Farzaneh Saki, Parvin Safarpour, Farzaneh Ramezani, Leila Youzbashi","doi":"10.1186/s13063-025-09036-w","DOIUrl":"10.1186/s13063-025-09036-w","url":null,"abstract":"<p><strong>Background: </strong>Knee osteoarthritis (OA) is a prevalent degenerative condition among older women, frequently causing pain, decreased mobility, and reduced quality of life. As the global population ages, effective and accessible non-pharmacological interventions are urgently needed. This randomized controlled trial aims to evaluate the clinical and statistical effects of a 12-week BodyBalance exercise program on symptoms and complications associated with OA in older women.</p><p><strong>Methods: </strong>A total of 40 older women aged 60-80 years with clinically diagnosed knee OA will be randomly assigned to either the intervention group or the control group. The intervention group will participate in a supervised BodyBalance training program, while the control group will maintain their usual activities without any structured exercise. Outcomes include evaluations of knee pain, balance, postural control, lower limb muscle strength, proprioception (knee and ankle), fear of falling, and overall quality of life.</p><p><strong>Discussion: </strong>The study is expected to demonstrate that BodyBalance significantly improves balance, reduces pain, and enhances functional mobility in older women with OA compared to no intervention. These findings may support the clinical adoption of mind-body exercise as a cost-effective strategy for improving independence and well-being in the aging population.</p><p><strong>Trial registration: </strong>https://irct.behdasht.gov.ir/trial/68467 . Registered on 15 April 2023. Retrospectively registered.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"336"},"PeriodicalIF":2.0,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970717","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":"Statistical analysis plan for a parallel group randomized clinical trial comparing schema therapy versus treatment as usual for outpatients with difficult-to-treat depression (DEPRE-ST).","authors":"Ida-Marie T P Arendt, Matthias Gondan, Sophie Juul, Lene Halling Hastrup, Carsten Hjorthøj, Stine B Moeller","doi":"10.1186/s13063-025-09012-4","DOIUrl":"10.1186/s13063-025-09012-4","url":null,"abstract":"<p><strong>Background: </strong>\"Difficult-to-treat\" depression - here operationalized as either chronic or treatment-resistant depression - encompasses about one third of all patients with depression. Despite its considerable size, the patient group is understudied, and evidence-based psychotherapeutic treatment options are currently limited. The DEPRE-ST trial therefore seeks to investigate beneficial and harmful effects of schema therapy for difficult-to-treat depression.</p><p><strong>Methods: </strong>This is a randomized multicenter parallel-group superiority clinical trial. A total of 129 patients will be randomized to receive either 30 sessions of individual schema therapy or psychotherapy according to Treatment As Usual, along with psychopharmacological treatment. Participants are assessed before randomization and at 6, 12, and 24 months after randomization. The primary outcome is depression symptoms (6-item Hamilton Rating Scale for Depression), assessed at 12 months. Secondary outcomes include health-related quality of life (European Quality of Life 5 Dimensions 5 Level Version), functional impairment (Work and Social Adjustment Scale), psychological wellbeing (WHO-5 Well-being Index), and negative effects of treatment (Negative Effects Questionnaire), alongside a range of patient-relevant exploratory outcomes. Blinding of treatment allocation is ensured for primary outcome assessors, statisticians, and the data safety and monitoring committee. The primary outcome will be analyzed with multilevel linear regression, with conservative multiple imputation for missing data, and presented as the covariate-adjusted difference between treatments' change scores with its 95% confidence intervals. Further, a health economic analysis will be performed.</p><p><strong>Discussion: </strong>This statistical analysis plan was developed and submitted before unblinding of data to ensure transparency and diminish bias in selection, analysis, and reporting of results.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05833087. Registered on 15th April 2023. https://clinicaltrials.gov/study/NCT05833087?term=depre-st&checkSpell=false&rank=1.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"334"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970675","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":"Study protocol for a prospective, randomized controlled confirmatory clinical investigation to evaluate the safety and efficacy of a multidisciplinary digital therapeutics in patients with patellofemoral pain syndrome.","authors":"Tae Hyun Park, Chan Yoon, Jae Hyeon Park, Sanghee Lee, Chi-Hyun Choi, Chong Bum Chang, Jin Goo Kim","doi":"10.1186/s13063-025-09030-2","DOIUrl":"10.1186/s13063-025-09030-2","url":null,"abstract":"<p><strong>Background: </strong>Patellofemoral pain is a prevalent knee condition affecting up to 40% of individuals, especially females aged teens to 50 s. Standard treatments, including exercise therapy, often yield insufficient long-term results, partly due to low compliance and psychological factors like depression and catastrophizing of pain. A digital therapeutics \"MORA Cure PFP,\" which combines structured progressive exercise and cognitive behavioral therapy via an app, offers a solution to overcome the limitations of conventional treatment for patellofemoral pain patients.</p><p><strong>Methods: </strong>To evaluate the safety and efficacy of MORA Cure PFP, a two-arm controlled trial will enroll 216 patients diagnosed with patellofemoral pain randomly assigned in a 1:1 ratio to treatment and control groups. The treatment group will use the app, while the control group will perform self-guided exercises using educational materials. This trial aims to determine if the treatment group shows greater reduction in usual pain intensity scores at 8 weeks compared to the control group. Additional assessments include worst pain, knee function, depression, and pain catastrophizing levels.</p><p><strong>Discussion: </strong>Key design elements of the clinical trial, such as control group selection, inclusion/exclusion criteria, number of patients, and primary endpoint, were designed with consideration for not only medical perspectives but also regulatory aspects of software as a medical device, including device approval and health technology assessment.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov., NCT06260865, registered 15th February 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"328"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403444/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970726","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":"Preoperative focused echocardiography on patients with fractured neck of femur. ECHONOF-III trial: study protocol for a multicenter randomized controlled trial.","authors":"Ximena Cid-Serra, Alistair Royse, Andrea Bowyer, David Canty, Daniel Sessler, Sandy Clarke-Errey, Andre Denault, Dina LoGiudice, Guy Ludbrook, D-Yin Lin, Yang Yang, Kavi Haji, Lisa Zucherrelli, Andrew J Palmer, Benjamin Piper, Thar Nyan Lwin, Stefan Dieleman, David Eccleston, Alwin Chuan, Richard Cooper, Gregory Henderson, Colin Royse","doi":"10.1186/s13063-025-09060-w","DOIUrl":"10.1186/s13063-025-09060-w","url":null,"abstract":"<p><strong>Background: </strong>Hip fractures are common in older people and are associated with high perioperative mortality. Prompt surgical intervention within the first 48 h of fraction reduces complications; however, surgical urgency often precludes a comprehensive preoperative cardiac evaluation. Preliminary data suggests that performing a focused cardiac ultrasound (FCU) before surgery may reduce postoperative complications. We therefore propose to test the primary hypothesis that FCU reduces a 30-day composite of mortality and serious complications.</p><p><strong>Methods: </strong>We plan a definitive multicenter pragmatic randomized trial that will enroll 2000 adults with hip fractures. Participants will be randomized before surgery to either receive FCU as part of their preoperative assessment or to routine care without FCU. FCU is a brief, 10-min, goal-directed echocardiography performed at the patient's bedside. FCU will be conducted by physicians trained in FCU and the information gathered will be shared immediately with all clinicians involved in the patient's care (anesthesiologists, orthopedic surgeons, geriatricians). The primary outcome will be a 30-day composite of all-cause mortality, hospital readmission, acute kidney injury, cardiac failure, and myocardial injury after noncardiac surgery. Secondary and exploratory outcomes include hospital length of stay, days to return to original residence, postoperative recovery, and quality of life. Additionally, a health cost analysis will be conducted to weigh costs against benefits.</p><p><strong>Discussion: </strong>Our large RCT aims to determine whether preoperative focused ultrasound examinations of hip fracture patients reduce serious postoperative complications, improves the quality of recovery, improves life quality, and is cost-effective.</p><p><strong>Trial registration: </strong>Registration number: ACTRN12622001546741. Date registered 14/12/2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"333"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403293/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970708","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":"Combining mental health and climate-smart agricultural interventions to improve food security in humanitarian settings: study protocol for the THRIVE cluster-randomized controlled trial with mothers in Nakivale refugee settlement, Uganda.","authors":"Jonathan Hall, Herbert E Ainamani, Phaidon T B Vassiliou, Stefan Döring, Gustaf Gredebäck, Kirsi Peltonen, Florian Scharpf, Umay Sen, Matthias Sutter, James I Walsh, Tobias Hecker","doi":"10.1186/s13063-025-09042-y","DOIUrl":"10.1186/s13063-025-09042-y","url":null,"abstract":"<p><strong>Background: </strong>Climate extremes in Africa threaten the food security of war-affected refugees, who often experience mental health challenges that hinder their capacity for agricultural adaptation. Cost-effective, climate-smart farming interventions are crucial for addressing food insecurity in humanitarian contexts, yet evidence on their effectiveness is limited, and the potential benefits of integrating them with mental health interventions remain unexplored. We hypothesize that the success of agricultural interventions, especially under adversity, is influenced by mental health and psychological functioning.</p><p><strong>Methods: </strong>This study employs a three-arm, parallel-group, cluster-randomized controlled trial (cRCT) in the Nakivale refugee settlement, Uganda. Thirty villages within the settlement will be randomized in a 1:1:1 allocation ratio to one of three conditions: Enhanced Usual Care, a Home Gardening Intervention (HGI) or HGI combined with the peer-delivered psychosocial intervention Self-Help Plus (SH + HGI). A total of 900 refugee mothers and their children (aged 3-4 years) will be enrolled, with 30 dyads per village. The primary outcome is food insecurity at 12 months post-intervention, assessed using the Food Insecurity Experience Scale (FIES). Secondary outcomes include dietary diversity, child malnutrition and mothers' psychological distress. Data will be collected at baseline, 3-month and 12-month follow-ups. Primary analyses will use an intention-to-treat (ITT) approach.</p><p><strong>Discussion: </strong>This study will shed light on the role of mental health in agricultural adaptation for food security, evaluating the efficacy of scalable, cost-effective interventions in a refugee setting. The findings will have implications for the design and implementation of integrated food security and mental health programs in humanitarian and other resource-constrained settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06425523. Registered on 24 May 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"331"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970280","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":"Sensor-controlled digital game for Native American adults in the Lumbee Tribe with hypertension self-management: study protocol for a randomized controlled trial.","authors":"Kavita Radhakrishnan, Cheongin Rachel Im, Jada L Brooks, Gail Currin Fallon, Angelica Rangel, Christine Julien, Matthew O'Hair, Huigang Liang, John Lowe","doi":"10.1186/s13063-025-09026-y","DOIUrl":"10.1186/s13063-025-09026-y","url":null,"abstract":"<p><strong>Background: </strong>Hypertension is a major risk factor for cardiovascular (CV) health in Native Americans (NAs), contributing to disparities in mortality, hospitalizations, and complications that include stroke and kidney diseases. However, despite the benefits of lifestyle modifications for CV health, systemic and cultural barriers hinder their adoption. To promote self-care behaviors, interventions must be culturally tailored and sustainable. Digital games (DGs) offer a promising, community-based approach to enhance self-care for hypertension (HTN) in NAs, aligning with traditional NA practices in which games foster skill-building and engagement. This study focuses on the Lumbee NA community, which faces significant HTN-related disparities. Using community-based participatory research, we are developing a culturally tailored, native-sensor-controlled digital game (N-SCDG) to support HTN self-care behaviors.</p><p><strong>Methods: </strong>This is a prospective, randomized (1:1) controlled clinical trial with two groups, to evaluate the impact of a culturally tailored N-SCDG on engagement in HTN self-care behaviors and related health outcomes among Lumbee adults at 3 and 6 months. Adults aged ≥ 18 years from the Lumbee tribal community in Robeson County and diagnosed with HTN will be randomized into an N-SCDG intervention group or a sensor-only control group. Both groups will receive a Fitbit activity tracker to monitor physical activity (PA). The N-SCDG group will engage in the game, which incorporates evidence-based HTN education, while the control group will receive the same HTN education in written format. The primary outcome is the mean daily step count, recorded by the activity tracker at 3 and 6 months. Secondary outcomes include systolic blood pressure (SBP), diastolic blood pressure (DBP), BP control, HTN knowledge, self-efficacy, motivation for self-care, quality of life (QoL), and cardiac hospitalization rates.</p><p><strong>Discussion: </strong>This evaluation of an N-SCDG to enhance HTN self-care in Lumbee adults will integrate culturally relevant design with evidence-based education and thus address a gap in use of digital health tools for NAs. The findings will provide vital data on the impact of digital health interventions to improve HTN outcomes and advance health equity in underserved NA communities.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05671406. Registered on January 9, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"329"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403476/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970653","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":"Optimizing short-term antibiotic treatment in patients with acute cholangitis: study protocol for an open-label randomized controlled trial (the BOLT-P3 trial).","authors":"Sakue Masuda, Yoshinori Imamura, Karen Kimura, Makomo Makazu, Jun Kubota, Hiroshi Takihara, Ryuhei Jinushi, Tomoaki Fujikawa, Kyohei Maejima, Aya Kawanishi, Ryuichi Yamamoto, Shogo Noda, Taiji Koyama, Ayumu Sugitani, Shomei Ryozawa, Kazuya Koizumi","doi":"10.1186/s13063-025-09077-1","DOIUrl":"10.1186/s13063-025-09077-1","url":null,"abstract":"<p><strong>Background: </strong>Acute cholangitis (AC) frequently presents as a community-acquired infection and is associated with a high prevalence of antibiotic use among infectious diseases. The Tokyo Guidelines 2018 (TG18) recommend 4-7 days of antibiotic administration after biliary drainage. However, this recommendation lacks strong evidence of its effectiveness and is primarily based on heterogeneous clinical findings and expert opinions. Recent retrospective studies have advocated a shorter 1- to 3-day antibiotic course as effective for AC treatment, prompting the need to reassess the treatment duration to achieve therapeutic efficacy while minimizing resistance and adverse effects.</p><p><strong>Methods: </strong>We designed a multicenter, non-blinded, randomized trial to evaluate the efficacy of short-course therapy compared to standard-course therapy for AC management. The short-course therapy group will receive 1-3 days of intravenous (IV) antibiotic treatment after successful biliary drainage compared to 4-7 days of IV antibiotics after successful biliary drainage for the standard-course therapy group. The primary outcome is the clinical cure rate within 14 days from the endoscopic retrograde cholangiopancreatography (ERCP) procedure. Participants will be allocated to either treatment course using a minimization method in a non-blinded, randomized manner, with stratification factors including condition severity and facility. We determined that 210 participants would be required to achieve a statistical power of 90% with a one-sided significance threshold of 2.5% and a non-inferiority limit of 10%.</p><p><strong>Discussion: </strong>This phase 3 trial aims to determine the non-inferiority of short-course therapy over standard-course therapy. Shortening the duration of antibiotic administration may mitigate the emergence of resistant bacteria, adverse events, and reduce hospital stay length and healthcare costs. https://jrct.niph.go.jp/re/reports/detail/73862 TRIAL REGISTRATION: This study was registered at the Japan Registry of Clinical Trials under registry number jRCT1031230709. Registered on 14 March 2024, https://jrct.niph.go.jp/re/reports/detail/73862.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"324"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12400583/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970677","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: Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men.","authors":"Corina Lelutiu-Weinberger, Mircea L Filimon, Anna M Zavodszky, Mihai Lixandru, Lucian Hanu, Cristina Fierbinteanu, Raluca Patrascu, Adrian Streinu-Cercel, Sergiu Luculescu, Maria Bora, Irina Filipescu, Cristian Jianu, Lisa B Hightow-Weidman, Aimee Rochelle, Brian Yi, Nickie Buckner, Sarit A Golub, Ilana Seager van Dyk, Julian Burger, Fan Li, John E Pachankis","doi":"10.1186/s13063-025-09106-z","DOIUrl":"10.1186/s13063-025-09106-z","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"332"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403586/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970376","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":"Optimizing bevacizumab dosing in first-line ovarian cancer treatment: the PGOG-ov1 trial.","authors":"Marta Ostrowska-Leśko, Radosław Mądry, Marcin Bobiński","doi":"10.1186/s13063-025-09062-8","DOIUrl":"10.1186/s13063-025-09062-8","url":null,"abstract":"<p><p>The management of advanced ovarian cancer has significantly developed with the integration of bevacizumab into standard therapeutic regimens. While the efficacy of bevacizumab has been established in trials such as GOG218, ICON7, and PAOLA-1, there remains a gap in understanding the advantages of the 7.5 mg/kg dose over the 15 mg/kg regimen. This study addresses this gap by evaluating the efficacy, safety, and cost effectiveness of these two dosing strategies, considering the heterogeneity of patient profiles, including BRCA mutation status and homologous recombination deficiency (HRD). This multicenter, randomized clinical trial will recruit patients with newly diagnosed, advanced-stage (FIGO III/IV) ovarian, fallopian tube, or primary peritoneal cancer. Participants will undergo three cycles of neoadjuvant chemotherapy with bevacizumab, followed by interval debulking surgery and randomization into four treatment arms stratified by BRCA and HRD status. Patients will receive either 7.5 mg/kg or 15 mg/kg bevacizumab in combination with chemotherapy during the adjuvant treatment phase and continue with maintenance therapy for up to 64 weeks, with or without the addition of olaparib. The primary endpoint is progression-free survival. The secondary endpoints include the overall response rate, quality of life, and safety profile. Data analysis focuses on subgroup evaluation of the influence of BRCA and HRD status on treatment outcomes. This study is expected to provide critical insights into optimizing bevacizumab dosing, potentially enabling the inclusion of cost-effective and safer treatment protocols without compromising efficacy. TRIAL REGISTRATION: EUCT number: 2023-509659-15-00. Registered on 09.07.2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"325"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12400637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970742","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}