Trials最新文献

{"title":"Bougie versus endotracheal tube alone on first-attempt intubation success in prehospital emergency intubation in patients without predictors of difficult intubation: protocol for the BETA randomized controlled trial.","authors":"Quentin Le Bastard, Joel Jenvrin, Aurélie Gaultier, Emmanuel Montassier","doi":"10.1186/s13063-025-09046-8","DOIUrl":"10.1186/s13063-025-09046-8","url":null,"abstract":"<p><strong>Background: </strong>Prehospital airway management is a critical and high-risk procedure in emergency medicine. First-pass intubation success is essential to reduce complications such as hypoxemia, aspiration, and hemodynamic instability. Although the bougie is commonly used in inhospital settings for difficult intubations, its routine use in first-attempt prehospital intubation in patients without difficult airway predictors has not been evaluated in randomized controlled trials.</p><p><strong>Methods: </strong>The BETA study is a multicenter, randomized, controlled, single-blinded superiority trial comparing bougie-assisted intubation with standard endotracheal tube intubation in adult patients (≥ 18 years) requiring prehospital intubation without predictors of difficult airway. A total of 710 participants will be randomized (1:1) across 10 French mobile intensive care units (MICUs). The primary outcome is first-attempt intubation success. Secondary outcomes include adverse events, glottic view, procedure duration, desaturation, perceived difficulty, and airway injuries. Data will be analyzed using logistic regression with a mixed model.</p><p><strong>Discussion: </strong>This trial will be the first to assess whether the routine use of a bougie improves first-attempt intubation success in prehospital settings. If successful, the intervention could shape future airway management practices.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06307392. Registered on March 26, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"327"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403556/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970698","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":"Telemedical care system for the treatment of arterial hypertension using recommendation algorithms to support diagnostic and therapeutic decisions-study protocol for a single-center, randomized, controlled, open-label SOT-ART-HT trial.","authors":"Dawid Lipski, Katarzyna Lewandowska, Sebastian Żurek, Mateusz Wiśniewicz, Przemysław Piróg, Andrzej Tykarski, Paweł Uruski","doi":"10.1186/s13063-025-09044-w","DOIUrl":"10.1186/s13063-025-09044-w","url":null,"abstract":"<p><strong>Background: </strong>Arterial hypertension is a global issue and achieving the blood pressure control is a challenge. It has been suggested that telemonitoring benefits these patients but there is a lack of research evaluating tools to assist doctors in caring for patients with arterial hypertension. Herein, we detail a protocol for a single-center, randomized, open-label study with a control group to develop a blood pressure monitoring system with a built-in algorithm supporting the physician's decisions.</p><p><strong>Methods: </strong>Two hundred patients aged 18-80 with a confirmed diagnosis of arterial hypertension and uncontrolled blood pressure during the screening visit will be recruited for the study. Patients with suspected or diagnosed secondary hypertension and pregnant/breast-feeding women will be excluded. In the initial study phase, a system will be developed for remote blood pressure monitoring, recording measurements, and detecting situations requiring medical assessment and potential intervention to identify patients needing urgent medical attention through innovative analysis of blood pressure measurements and co-morbidity data. Next, telemetric and algorithm-supported care will be compared to the standard care of hypertensive patients. Patients will be randomized 1:1 to each group and be observed for 6 months. Pharmacotherapy will be modified, office blood pressure, home blood pressure, and 24-h ambulatory blood pressure will be measured, and the presence of organ complications will be checked during visits.</p><p><strong>Discussion: </strong>The primary endpoints include the time from study enrollment to the day of achieving blood pressure control and achieving blood pressure control within 6 months. Secondary endpoints involve some other parameters of blood pressure control and the costs analyses. The results are expected after 2026 and are anticipated to increase patient-to-physician ratios, allow the remote identification of urgent cases, reduce outpatient appointments, and achieve faster blood pressure control through telemetric observation with the algorithm compared to standard care.</p><p><strong>Trial registration: </strong>Clinical Trials NCT06722625, December 6, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"330"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12403419/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970746","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":"SATURN MRI: study protocol for the statin use in intracerebral hemorrhage patients MRI ancillary study.","authors":"Sarah Marchina, Lydia D Foster, Sharon D Yeatts, Pooja Khatri, Kimberlee Bernstein, Aaron Perlmutter, Elizabeth C Heistand, Eric E Smith, Mike Sharma, Joseph P Broderick, Vasileios-Arsenios Lioutas, Joan Marti-Fabregas, Magdy Selim, Ashkan Shoamanesh","doi":"10.1186/s13063-025-09024-0","DOIUrl":"https://doi.org/10.1186/s13063-025-09024-0","url":null,"abstract":"<p><strong>Background: </strong>The benefit-risk of statins in patients with lobar intracerebral hemorrhage (ICH) is under investigation in the StATins Use in intRacerebral hemorrhage patieNts (SATURN) trial. The relationship between statin use in ICH survivors, MRI markers of cerebral small vessel disease (CSVD), and outcomes such as recurrent ICH or major adverse cardiovascular or cerebrovascular events (MACCE) is unclear. The ancillary study, SATURN-MRI, intends to evaluate the interrelationship between statin use, the progression of MRI markers of CSVD, and cognitive and functional outcomes. Additionally, SATURN-MRI aims to assess whether baseline MRI markers of CSVD interact with statin continuation for the outcomes of recurrent ICH or MACCE in patients with lobar ICH.</p><p><strong>Methods: </strong>A target of 894 SATURN participants will undergo a baseline MRI within 7 days of randomization and a repeat MRI at the end of the 24-month follow-up period. Any SATURN subject without contraindication to MRI has the option to participate in SATURN MRI. MRIs will be reviewed by blinded central raters to assess for the presence and burden of markers of CSVD and their progression. The primary outcome is new cerebral microbleeds and/or sulci with cortical superficial siderosis identified on T2*-weighted (GRE, SWI or SWAN) images between baseline and end-study MRI. Additional outcomes include the progression of white matter hyperintensity and incidence of covert infarcts.</p><p><strong>Discussion: </strong>The results will provide insights about the interrelationship between the effects of statins, progression of MRI markers of CSVD, and functional and cognitive outcomes. They might lead to the validation of MRI markers as tools to assist with individualized decision-making regarding the effects of statins continuation/discontinuation in patients with lobar ICH.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT03936361. SATURN Trial was originally registered on May 1, 2019 and modified on February 28, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"323"},"PeriodicalIF":2.0,"publicationDate":"2025-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970695","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":"Paediatric Autism Communication Therapy (PACT) versus management as usual in autistic children: a protocol for a Danish pragmatic, national, randomised clinical trial: DAN-PACT.","authors":"Sonja Martha Teresa Ziegler, Pia Jeppesen, Jens Christiansen, Charlotte Engberg Conrad, Kirstine Agnete Davidsen, Georgij Engkjær-Trautwein, Janus Engstrøm, Birgitte Fagerlund, Martin Vestergaard Gøtzsche, Lene Halling Hastrup, Janus Christian Jakobsen, Anne Mette Kirk, Marlene Birciet Lauritsen, Anne Katrine Pagsberg, Mette Agner Pedersen, Tina Røndrup Kilburn, Per Hove Thomsen, Manon Varenne, Niels Bilenberg","doi":"10.1186/s13063-025-09017-z","DOIUrl":"https://doi.org/10.1186/s13063-025-09017-z","url":null,"abstract":"<p><strong>Background: </strong>Despite autism being a lifelong developmental condition affecting approximately 2% of children and young people worldwide, interventions aimed at improving core autism features are sparse. Paediatric Autism Communication Therapy (PACT) is among the first parent-mediated developmental interventions, provided in naturalistic settings, to show promising results in core feature improvement.</p><p><strong>Methods: </strong>DAN-PACT is an investigator-initiated, independently funded, multicentre, parallel group superiority, randomised clinical trial, which aims to assess benefits and harms of PACT in 2.0-6.9-year-old children with a recent autism diagnosis, comparing PACT combined with management as usual to management as usual alone. Two hundred eighty autistic children from all regions of Denmark will be included. Primary outcome assessors, data managers, statisticians, and conclusion drawers will be blinded. The primary outcome is magnitude of autism features as measured by the ADOS-2 CSS. The sample size calculation is based on a minimal important difference of 0.66 points, corresponding to a 2-3-point difference in ADOS raw scores. Secondary outcomes are changes in child social communication skills measured with the BOSCC, child adaptive skills measured with the VABS-3, and parents' assessment of their own and their child's quality of life. Several exploratory outcomes will be assessed, including adverse events during the trial period. Trial staff will be trained to perform both PACT and enhanced management as usual, assessing manual fidelity of PACT and measuring a broad range of benefits and harms with repeated measures.</p><p><strong>Discussion: </strong>DAN-PACT aims to minimise risks of bias, anchor the trial in a naturalistic clinical setting, and extend the scope of outcome measures used in previous PACT studies, achieved by blinding raters to all observational outcomes, including a large sample of young autistic children, and using an enhanced management as usual control sample. Trial limitations are the risk of missing data and the inability to blind parent participants to their group allocation and their rating of several secondary and exploratory outcomes. In addition, there is no consensus on the magnitude of the minimal important difference on ADOS-2 CSS or BOSCC, which are therefore estimated pragmatically.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05673096. Registered on December 22, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"322"},"PeriodicalIF":2.0,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970728","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 blood flow restriction training combined with postoperative continuous passive motion in elderly patients after total knee arthroplasty: study protocol for a randomized controlled trial.","authors":"Xinming Tian, Shuang Wang, Tengfei Zhou, Qiheng Zhao","doi":"10.1186/s13063-025-09071-7","DOIUrl":"https://doi.org/10.1186/s13063-025-09071-7","url":null,"abstract":"<p><strong>Background: </strong>Postoperative rehabilitation is essential for functional recovery following total knee arthroplasty (TKA), a surgical treatment frequently used to treat knee joint problems. By briefly limiting blood supply to the limbs, blood flow restriction (BFR) training is a new and widely used rehabilitation technique that improves muscle strength and endurance. In the context of postoperative recovery after total knee arthroplasty (TKA), it has recently drawn a lot of attention. The purpose of this study is to assess how well postoperative continuous passive motion (CPM) and preoperative BFR training can enhance rehabilitation results for older patients having total knee arthroplasty. If successful, this strategy could provide a novel supplement to traditional rehabilitation methods for this population.</p><p><strong>Methods: </strong>This study is a randomized controlled trial comprising 160 TKA patients, who will be randomly allocated to either the combined intervention group or the CPM group, with 80 individuals in each cohort. All patients will have standard preoperative treatment. The intervention group will also undergo preoperative BFR training twice daily for 2-3 days before surgery, in conjunction with postoperative CPM therapy. Joint range of motion (ROM), visual analog scale (VAS) score, activities of daily living (ADL) score, hospital for special surgery (HSS) knee score, postoperative swelling (change in knee joint circumference), C-reactive protein (CRP) levels, and 30-s chair stand test (30s-CST) performance are among the outcome measures. At baseline, on postoperative day 1, day 5, month 1, and month 3, data will be gathered.</p><p><strong>Discussion: </strong>This study introduces an innovative rehabilitation approach that, to our knowledge, uniquely integrates preoperative blood flow restriction training with postoperative continuous passive motion in patients having total knee arthroplasty. This combined method aims to use the muscle-building benefits of BFR along with the movement-supporting benefits of CPM, which could lead to faster recovery and better strength improvement. If a short-term solution is effective, it will be more effectively implemented in hospitals.</p><p><strong>Trial registration: </strong>The Ethics Committee of the Third Bethune Hospital of Jilin University accepted this study, with reference number (2024) Clinical Research Application No. 2024112815, on November 28, 2024. China Clinical Trial Registry (ChiCTR) ChiCTR2400094134. Registered on November 28, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"320"},"PeriodicalIF":2.0,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12395669/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970648","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 motor imagery training on gait and muscle synergy after total knee arthroplasty: study protocol for a randomized controlled trial.","authors":"Junyang Lu, Xiaoguang Chen, Thanaporn Tunprasert, Weiguo Liu, Haowen Tuo","doi":"10.1186/s13063-025-09053-9","DOIUrl":"https://doi.org/10.1186/s13063-025-09053-9","url":null,"abstract":"<p><strong>Background: </strong>Total knee arthroplasty has proven to be an effective method for treating severe osteoarthritis, but this procedure may induce abnormal symptoms of gait and muscle synergy after surgery. Motor imagery is a special means of training that can heighten cortical-spinal excitability and spinal transmission efficiency. The training method can fortify muscle strength, enhance joint range of motion, and ameliorate gait and muscle synergy control patterns, all while avoiding postoperative intense pain resulting from high-intensity exercise. This study aims to investigate whether motor imagery training can improve patients' gait function and muscle synergy patterns, and to establish the effectiveness of motor imagery training in fostering postoperative knee joint function recovery in total knee arthroplasty patients.</p><p><strong>Methods: </strong>This study will utilize a single-blind randomized clinical trial methodology. The research will aim to recruit forty patients from Guilin Medical College Affiliated Hospital who have undergone total knee arthroplasty and who meet the trial criteria. Random allocation to either the experimental group or the control group will be conducted for these patients. Participants in both the experimental and control groups will receive a 6-week conventional training intervention beginning on the first day after surgery and 5 sessions of rehabilitation training per week. In addition, the participants in the experimental group will receive motor imagery training alongside the conventional training programme. The parameters of gait, muscle synergy, lower limb kinematics and kinetics, isokinetic muscle strength, proprioception, and knee joint scoring will be measured one week before surgery and at 3, 6, and 12 weeks after surgery.</p><p><strong>Discussion: </strong>This protocol is to evaluate the function of motor imagery training after total knee arthroplasty by analysing the parameters of gait and muscle synergy. The outcomes of this trial are expected to affirm the utility of motor imagery training in the postoperative rehabilitation of total knee arthroplasty patients.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2400082292. Registered on March 26, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"321"},"PeriodicalIF":2.0,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12395707/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970659","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":"Sugammadex or Neostigmine for prevention of post-operative pulmonary complications after major abdominal or thoracic surgery: study protocol for the SINFONIA (Sugammadex for preventioN oF pOst-operative pulmonary complIcAtions) randomised controlled superiority trial.","authors":"Jonathan A Silversides, Louise Savic, Louise Hiller, Amy Hopkins, Katie Booth, Jennifer Dorey, Richard Smithson, James Mason, Samuel Frempong, Christina May, Ramani Moonesinghe, Ciara M O'Donnell, Benedict Creagh-Brown, Rebecca Kandiyali, Joyce Yeung, Rupert Pearse","doi":"10.1186/s13063-025-08987-4","DOIUrl":"https://doi.org/10.1186/s13063-025-08987-4","url":null,"abstract":"<p><strong>Background: </strong>Post-operative pulmonary complications (PPCs) are an important source of morbidity and mortality after major abdominal and thoracic surgery. The use of neuromuscular blocking drugs in general anaesthesia is an important risk factor for PPCs. The incomplete reversal of this neuromuscular blockade at the end of surgery leads to residual weakness of respiratory muscles and predisposes to aspiration of pharyngeal contents, hypoventilation, and thus to PPCs such as atelectasis and pneumonia. Two reversal drugs for neuromuscular blocking agents are available: neostigmine and sugammadex. Compared with neostigmine, sugammadex use results in more rapid reversal of neuromuscular blockade, and small clinical efficacy studies have suggested an associated lower incidence of PPCs. The comparative clinical effectiveness of the two drugs in reducing length of hospital stay or mortality is uncertain. Moreover, a potential safety concern with sugammadex is the relatively high incidence of life-threatening allergic reactions in countries where this drug has been widely used over the last decade.</p><p><strong>Methods: </strong>SINFONIA is a pragmatic, randomised, open-label, parallel group, superiority trial with an internal pilot which aims to compare the clinical and cost effectiveness of the two available drugs for reversal of neuromuscular blockade, sugammadex and neostigmine, in patients aged 50 years or older undergoing major abdominal or non-cardiac thoracic surgery. The trial will randomise 2500 patients from approximately 40 centres in the UK. The primary outcome will be days alive and out of hospital at 30 days (DAH-30), with key secondary outcomes of PPC incidence, quality of life, and mortality up to 180 days. An embedded observational study will investigate the rate of allergic sensitisation following exposure to sugammadex.</p><p><strong>Discussion: </strong>The SINFONIA trial addresses an important question for anaesthetists and for patients undergoing major abdominal and thoracic surgery. The choice of reversal agent for neuromuscular blockade between sugammadex and neostigmine is currently largely a matter of anaesthetist preference. A growing body of evidence suggests that sugammadex may reduce the incidence of post-operative pulmonary complications relative to neostigmine. This pragmatic clinical effectiveness trial will provide robust evidence as to the effects of the two drugs on patient-centred outcomes such as DAH-30, as well as on cost effectiveness and the incidence of allergic sensitisation.</p><p><strong>Trial registration: </strong>The trial was registered on the ISRCTN database ( https://www.isrctn.com ) prior to opening to recruitment (registration no 15109717).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"319"},"PeriodicalIF":2.0,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392639/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970723","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The \"SleepWell\" intervention for patients with insomnia and persistent pain: a study protocol for a randomised waiting-list controlled trial of a cognitive behavioural group therapy programme.","authors":"Jan H Rosenvinge, Svein Bergvik, Karin Abeler, Kristin Tvedt, Torkil Berge, Nina Lang, Maja Wilhelmsen, Lena Danielsson, Gunn Pettersen, Oddgeir Friborg","doi":"10.1186/s13063-025-09041-z","DOIUrl":"10.1186/s13063-025-09041-z","url":null,"abstract":"<p><strong>Background: </strong>Patients with persistent pain and comorbid insomnia often experience a dual burden with significant day- and nighttime impairments. This comorbidity is associated with health problems like depression and a self-perpetuating vicious circle in which pain and insomnia symptoms mutually reinforce each other. Cognitive behavioural therapy for insomnia (CBT-i) has demonstrated efficacy in facilitating the behavioural and psychological changes necessary to improve sleep. However, its applicability to patients with the insomnia-pain comorbidity condition is underexplored. We will expand the knowledge base of CBT-i to this patient group by examining the effects on core insomnia symptoms, including sleep onset, the frequency and duration of nightly and early morning awakenings, sleep efficiency and daytime impairments at post-test and follow-up. Secondary outcomes include reductions in pain intensity and interference, depression and fatigue; improved pain acceptance and quality of life; and more adaptive sleep-related beliefs. This study also explores mediators of the expected effects, patient experiences of the feasibility and acceptability of the intervention and how these experiences relate to individual differences in treatment benefits.</p><p><strong>Methods: </strong>The study includes hospital patients with a chronic pain condition according to the criteria from the International Association for the Study of Pain and a DSM-5 diagnosis of insomnia. The study will recruit 106 patients based on a power analysis that accounts for 20% dropout, and block-randomise them to a group-based CBT-i intervention or treatment as usual (TAU). The latter consists of consultations and potential pain- and sleep medication. The participant timeline includes a baseline registration, seven sessions of the CBT-i within a 10-week period, a post-test and two follow-up measurements at 4 and 12 months, respectively. The statistical analyses will be intention-to-treat and include random factors to adjust for data dependencies. Patients' experiences of feasibility and acceptability will be analysed using a reflexive thematic approach.</p><p><strong>Discussion: </strong>This study addresses a knowledge gap by evaluating the effectiveness of CBT-i adapted for patients with insomnia and non-malignant, persistent pain. Given positive findings, the study may support clinical recommendations by providing empirical evidence for implementing psychological sleep interventions for somatic hospital patients having comorbid sleep issues.</p><p><strong>Trial registration: </strong>Clinical Trials.gov ID NCT06351839. Registered 08 April 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"314"},"PeriodicalIF":2.0,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392562/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970299","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":"StOPping Hypertension and imprOving Children's Lives after KidnEy TranSplantation (SOPHOCLES): study protocol for a randomized controlled multicenter trial.","authors":"Carl Grabitz, Nima Memaran, Rizky I Sugianto, Jeanine von der Born, Mila Bukova, Elena Lehmann, Ann-Kathrin Konuhov, Dennis Holzwart, Anika Großhennig, Elke Wühl, Bernhard M W Schmidt, Anette Melk","doi":"10.1186/s13063-025-09033-z","DOIUrl":"10.1186/s13063-025-09033-z","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular disease is a major morbidity in children after kidney transplantation, limiting life expectancy and impairing graft function. Arterial hypertension is the dominant cardiovascular risk factor and highly abundant in this patient group. Arterial hypertension can cause left ventricular hypertrophy, which is predictive of cardiovascular death. Left ventricular hypertrophy can be non-invasively assessed by measuring left ventricular mass. Observational data indicated that intensified blood pressure control was associated with a significant reduction of left ventricular mass. Based on evidence from the randomized controlled ESCAPE trial, intensified blood pressure control is recommended in children with chronic kidney disease prior to kidney replacement therapy. However, current treatment recommendations for pediatric kidney transplant patients follow the recommendations for otherwise healthy children and adolescents with arterial hypertension, i.e., suggesting a blood pressure target < 90th percentile.</p><p><strong>Methods: </strong>In the proposed multicenter, randomized, parallel group trial with blinded endpoint evaluation, we aim to include 170 pediatric patients who underwent a kidney transplantation more than 12 months ago. Patients will be randomly assigned 1:1 to an intensified blood pressure management group (blood pressure target ≤ 60th percentile) and a standard blood pressure management group (blood pressure target < 90th percentile). The primary endpoint is left ventricular mass after 24 months. Secondary endpoints are pulse wave velocity, intima media thickness, estimated glomerular filtration rate, and albuminuria. Achievement of blood pressure targets will be facilitated through blood pressure telemonitoring. Blood pressure values will be transmitted in real time to the treating physician and the trial's centralized study office allowing timely responses in case blood pressure values lie outside target range.</p><p><strong>Discussion: </strong>The proposed study will result in an evidence-based definition of blood pressure targets and will therefore have direct implications for the care of children after kidney transplantation. In case intensified blood pressure targets are effective, this should eventually lead to lower cardiovascular morbidity and subsequently lower cardiovascular mortality of pediatric kidney transplant recipients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06589947. Registered on September 6, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"315"},"PeriodicalIF":2.0,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392664/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970718","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":"Social media recruitment enhances participant diversity in dermatology clinical trial: findings from the SAFA trial.","authors":"Cherish Boxall, Susanne Renz, Beth Stuart, Ingrid Muller, Irene Soulsby, Jacqueline Nuttall, Karen Thomas, Kim S Thomas, Tracey H Sach, Megan Lawrence, Matthew J Ridd, Nick Francis, Paul Little, Zina Eminton, Gareth Griffiths, Alison M Layton, Alan Saji, Charlotte Cluff, Miriam Santer","doi":"10.1186/s13063-025-08994-5","DOIUrl":"10.1186/s13063-025-08994-5","url":null,"abstract":"<p><p>Recruitment and retention of participants remain critical challenges in clinical trials, often requiring innovative approaches to ensure sufficient enrolment and sustained engagement. Social media advertising offers the potential to reach target populations quickly by leveraging demographic, geographic and interest-based targeting. This mixed-methods observational study evaluates participant experiences and the effectiveness of various recruitment routes within a trial of a treatment for acne. Demographic variables, including age, ethnicity, acne severity and acne duration, were stratified primary care, secondary care, community and social media recruitment routes and 12 participant interviews were analysed using reflexive thematic analysis. Social media recruitment accounted for over half of participants (53.9%). It was particularly effective in recruiting individuals with higher acne severity (IGA ≥ 3; 57.5% of its recruits, n = 127), longer duration of disease (> 5 years history of acne; 60.2% of its recruits, n = 133) and from ethnic minority groups (9.0% of its recruits, n = 20), the latter being notably higher than the proportion recruited via primary care (1.5% of its recruits, n = 1). Slight variations in retention by recruitment route were observed, with social media (85%) and primary care (84%) achieving the highest retention rate at the 12-week follow-up. All routes lost between 25 and 32% of participants by the 24-week follow-up, signifying the importance of implementing effective retention strategies to keep participants engaged. Overall, participants found targeted social media advertisements to be an acceptable and convenient recruitment approach; initial signals of trust were provided by high-quality graphics and recognisable NHS and university logos, which coupled with responsive trial staff, were suggested to provide a seamless enrolment experience. This study demonstrates that social media recruitment can be an effective and acceptable component of a multi-route strategy for clinical trial enrolment.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"318"},"PeriodicalIF":2.0,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392518/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970680","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}