Trials最新文献

{"title":"Ultrashort wave therapy for chronic rhinosinusitis with nasal polyps: protocol for a randomized, double-blind, sham-controlled trial.","authors":"Ling Kong, Jinlong Zhang, Chuanmei Zhu","doi":"10.1186/s13063-025-09167-0","DOIUrl":"https://doi.org/10.1186/s13063-025-09167-0","url":null,"abstract":"<p><strong>Background: </strong>Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by persistent sinonasal inflammation and substantially impairs quality of life. Current treatments, including corticosteroids, surgery, and biologics, are limited by side effects and high recurrence rates. Ultrashort wave (USW) therapy, a non-invasive modality with purported anti-inflammatory effects, lacks robust evidence for its efficacy in CRSwNP.</p><p><strong>Methods: </strong>This single-center, double-blind, sham-controlled trial will randomize 150 patients with CRSwNP to receive either active USW therapy (50 mA, 27.12 MHz) or sham treatment for 20 min daily over 2 weeks, alongside standard medical care. The sole primary outcome is the change in the 22-item Sino-Nasal Outcome Test (SNOT-22) score from baseline to the 12-month follow-up. Key secondary outcomes include the change in the Lund-Kennedy endoscopic score at the 12-month follow-up. The primary outcome will be analyzed using a linear mixed-effects model, and sensitivity analyses will be conducted to handle missing data.</p><p><strong>Discussion: </strong>This trial aims to address a critical evidence gap regarding the efficacy of USW therapy for CRSwNP. If effective, USW therapy could offer a non-invasive adjunct, potentially reducing the burden of corticosteroids, surgery, and biologics while improving long-term patient outcomes. The findings will provide crucial evidence to inform clinical guidelines and direct future research.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry (ChiCTR2400092411). Registered on November 16, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"391"},"PeriodicalIF":2.0,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial.","authors":"Scott L Weiss, Fran Balamuth, Elliot Long, Graham C Thompson, Katie L Hayes, Hannah Katcoff, Marlena Cook, Elena Tsemberis, Christopher P Hickey, Amanda Williams, Sarah Williamson-Urquhart, Meredith L Borland, Stuart R Dalziel, Ben Gelbart, Stephen B Freedman, Franz E Babl, Jing Huang, Nathan Kuppermann","doi":"10.1186/s13063-025-09164-3","DOIUrl":"https://doi.org/10.1186/s13063-025-09164-3","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"390"},"PeriodicalIF":2.0,"publicationDate":"2025-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145245378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The CAM-P-OS study protocol: a prospective randomized multicenter trial evaluating an active controlled motion device in the rehabilitation of surgically treated, isolated ankle fractures of Weber types B and C.","authors":"Michael Nienhaus, Kai Kronfeld, Olga Schulowski, Claudia Wolf, Juergen Konradi, Ulrich Betz, Erol Gercek","doi":"10.1186/s13063-025-09169-y","DOIUrl":"https://doi.org/10.1186/s13063-025-09169-y","url":null,"abstract":"<p><strong>Background: </strong>Displaced ankle fractures classified as Weber types B and C are common across all age groups. The standard treatment involves open reduction and internal fixation, followed by a rehabilitation program that includes 6 weeks of partial weightbearing. During this period, both passive and active range-of-motion exercises are performed under the supervision of a physiotherapist. Recently, a new device has become available, allowing active controlled motion of the ankle joint at home on top of the normal rehabilitation protocol. The purpose of this controlled randomized trial was to evaluate the superiority of this device as a supplement in standard rehabilitation protocols after distal fibular fractures.</p><p><strong>Methods: </strong>This prospective controlled multicenter trial will include a minimum of 58 patients who have undergone surgical treatment for isolated distal fibular fractures of Weber types B and C. These patients will be randomized into 2 groups: Group 1 will undergo a standardized rehabilitation protocol with active and passive physiotherapy under partial weightbearing for 6 weeks with the active controlled motion device at home on top. Group 2 will receive the same rehabilitation without the device. Three German hospitals with different levels of care and 6 rehabilitation centers are involved in this study. The estimated study duration of 12 months started in October 2024. The follow-up will last 6 months after the recruitment of the last patient. The following assessments are performed: baseline after surgery; after 6 weeks; at 3 and 6 months; and with check-in calls after 2 and 4 weeks. The evaluation of effectiveness is based on FAOS, NRS, and SF-36 scores; changes in employment during the study; return-to-work; return-to-sports; and time-to-unrestricted weightbearing.</p><p><strong>Discussion: </strong>This trial aims to collect valid data to determine whether the use of an active controlled motion device as a supplement to a standardized physiotherapy protocol after surgical treatment of ankle fractures leads to significantly improved outcomes. After evaluation of the results by the German Joint Federal Committee, a final assessment is made to make this device part of a future treatment protocol in the aftercare of surgically treated distal fibular fractures of Weber types B and C.</p><p><strong>Trial registration: </strong>The trial is registered in the International Clinical Trials Registry Platform of the World Health Organization with the Main-ID DRKS00034202 on July 22nd, 2024 ( https://trialsearch.who.int/Trial2.aspx ?TrialID=DRKS00034202).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"388"},"PeriodicalIF":2.0,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145239737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of remote treatment on medical provider creative thinking and patient disclosure: protocol for the MED-CREATE trial.","authors":"Ayoub Bouguettaya, Elias Aboujaoude","doi":"10.1186/s13063-025-09121-0","DOIUrl":"https://doi.org/10.1186/s13063-025-09121-0","url":null,"abstract":"<p><strong>Background: </strong>Open doctor-patient communication is essential for accurate diagnosis and effective treatment. However, the communication modality (video consultation vs. in-person visit) may impact the process and create tradeoffs. Previous research suggests that while online communication negatively affects creative thinking, it can also enhance disclosure. This study seeks to investigate how the communication modality utilized in medical settings influences both creative idea generation on the part of clinicians and disclosure on the part of patients. Drawing upon established frameworks in health literacy, social identity theory, and cognitive psychology, we aim to examine how different communication modalities impact doctors' ability to generate solutions to clinical problems and patients' willingness to open up about these problems.</p><p><strong>Methods/design: </strong>This open-label, randomized controlled trial will recruit a sample of medical students in their final year and actors simulating patients. Participants will be randomly assigned to either online video consultations or in-person visits. During these consultations, medical students will be presented with patient cases involving participants told to act out conditions (i.e., real people given a script and told to pretend it represents their story and their symptoms) and tasked with interviewing the patients and generating potential diagnoses. The primary outcomes of the study will be threefold: (1) the number of ideas generated by medical students regarding the diagnosis (\"differential diagnosis\"-regardless of being correct or incorrect), (2) whether or not the accurate diagnosis is reached, and (3) patients' tendency toward disclosure.</p><p><strong>Discussion: </strong>This study will contribute insights into the impact of communication modality on the balance between creative problem-solving and disclosure in medical settings. By examining the complex links between communication modality, creativity, and disclosure, the findings can have implications for the rapidly growing telehealth field and help inform the design and implementation of effective communication strategies that enhance patient care.</p><p><strong>Trial registration: </strong>Trial is registered on ClinicalTrials.gov (Number NCT06784635). We also aim to pre-register this study on the Open Science Framework, as this is a behavioral science study.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"389"},"PeriodicalIF":2.0,"publicationDate":"2025-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145239808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early implantation of a transjugular intrahepatic portosystemic shunt (TIPS) in patients with liver cirrhosis and ascites (eTIPS): a multicentre, randomised controlled trial.","authors":"Dominik Bettinger, Marco Janoschke, Carolin Jenkner, Margit Kaufmann, Julia van Gessel, Hans-Heinrich Otter, Michael Schultheiss, Robert Thimme","doi":"10.1186/s13063-025-09038-8","DOIUrl":"10.1186/s13063-025-09038-8","url":null,"abstract":"<p><strong>Background: </strong>Portal hypertension is a major complication in patients with liver cirrhosis, leading to severe outcomes such as variceal bleeding and ascites. Transjugular intrahepatic portosystemic shunt (TIPS) has emerged as an effective interventional treatment of recurrent ascites and variceal bleeding. However, up to 30% of patients with recurrent ascites show TIPS refractory ascites, and prior data have shown that the frequency of paracenteses before TIPS implantation predicts ascites clearance indicating that TIPS implantation may be too late in some patients. Especially, patients with grade 2 ascites and a MELD score ≥ 15, or grade 3 ascites irrespective of MELD score at first decompensation with ascites face a high risk of further decompensation and mortality. Therefore, these patients may benefit from early TIPS implantation in order to improve post-TIPS mortality. We hypothesise that early TIPS implantation in these selected patients at the time of the first decompensation may improve transplantation-free survival compared to standard medical treatment (SMT).</p><p><strong>Methods: </strong>The eTIPS study is a prospective, randomised, open, multicenter interventional, superiority trial. Patients will be randomised 1:1 in the intervention group with TIPS implantation and in the SMT group. The primary endpoint is transplantation-free survival. Secondary endpoints include the time to ascites with need for paracentesis and quality of life assessed six and 12 months after randomisation.</p><p><strong>Discussion: </strong>Expanding the concept of early TIPS implantation to ascites management may offer significant survival benefits and may significantly change the treatment algorithm of patients with ascites.</p><p><strong>Trial registration: </strong>German Registry for Clinical Studies DRKS00034545. Registered on 20/02/2025. Clinical trials NCT06576934. Registered on 04/12/2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"385"},"PeriodicalIF":2.0,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12490027/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145213698","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":"A flexible module-based cognitive behavioral therapy for gaming disorder: study protocol of a randomized controlled trial.","authors":"Elin Arvidson, Annika Hofstedt, Anna Söderpalm Gordh","doi":"10.1186/s13063-025-09147-4","DOIUrl":"10.1186/s13063-025-09147-4","url":null,"abstract":"<p><strong>Background: </strong>Knowledge about gaming disorder has increased in recent years. However, more research is needed regarding treatment options for gaming disorder. The most studied treatment option today is cognitive behavioral therapy (CBT). However, due to the low number of high-quality trials, the certainty in the evidence is low. Only a handful of previous studies are randomized controlled trials, further affecting the evidence level. Many previously studied treatments are also resource-intensive, making it difficult to implement in routine care. In addition, few treatment studies so far include adults. Therefore, we aim to evaluate a flexible manual-based CBT-program for gaming disorder in a randomized controlled trial, including both adults and adolescents.</p><p><strong>Methods: </strong>A total of 160 patients will be recruited. Participants will be randomized to an intervention group receiving CBT treatment for approximately 12 weeks or to a waitlist control group. The primary outcome measure is the score on the Internet Gaming Disorder Scale 9- Short form. The questionnaire measures severity of gaming disorder before and after treatment. Assessments will be made at five time points, from the first visit to a 3-month follow-up. The participants randomized to the control group will remain on a waitlist for 12 weeks. During this time, the participants in the control group will receive the same questionnaires at the same time points as the intervention group. After 12 weeks, the control group will be offered the same treatment as participants in the intervention group. In an additional study, all participants will be followed up until 24 months after treatment.</p><p><strong>Discussion: </strong>This trial will evaluate the effects of a 12-week CBT-treatment for patients with gaming disorder, compared to no treatment. Increasing the knowledge of the effectiveness of CBT for gaming disorder will improve the ability to offer evidence-based care for this group of patients.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov NCT05328596. Registered on April 22, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"386"},"PeriodicalIF":2.0,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12490166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145213730","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 effectiveness of adding Braun anastomosis to standard Child reconstruction to reduce delayed gastric emptying after pancreatoduodenectomy (REMBRANDT): study protocol for a multicentre randomised-controlled trial.","authors":"B T M Strijbos, J S Hopstaken, C Endo, M de Vries, F Atsma, E Adang, P van der Wees, M G H Besselink, H van Santvoort, M den Dulk, B Groot Koerkamp, J S D Mieog, S Zeverijn, C J H M van Laarhoven, M W J Stommel","doi":"10.1186/s13063-025-09051-x","DOIUrl":"10.1186/s13063-025-09051-x","url":null,"abstract":"<p><strong>Background: </strong>Pancreatoduodenectomy (PD) is associated with a high risk of complications, such as delayed gastric emptying (DGE) (19-45%). Patients with DGE experience symptoms of nausea, vomiting, inability to tolerate solid food and prolonged dependence on a nasogastric tube (> 7 days), leading to extended hospital stay. A potential mean to reduce DGE is reconstruction after PD with addition of Braun's enteroenterostomy (BE), an anastomosis between the afferent and efferent jejunal limbs distal to the gastrojejunostomy (GJ). Previous prospective-cohort studies and few small randomised controlled studies demonstrated a beneficial effect of BE in reducing DGE. Aim of this study is to obtain robust evidence for the effectiveness of BE in reducing DGE in patients undergoing PD.</p><p><strong>Methods: </strong>The REMBRANDT trial is a multicentre, patient-observer blinded, randomised controlled trial. Adult patients undergoing open PD are recruited in 12 participating centres. Primary outcome is the incidence of DGE. Secondary outcomes include postoperative complications, such as postoperative pancreatic fistula, anastomotic leakage and mortality. Additionally, the study will assess length of hospital stay, patient-reported outcomes, functional outcomes after 12 months and costs. Randomisation is performed intraoperatively (1:1) with stratification of groups by centre, with a sample size of 128 patients per arm.</p><p><strong>Discussion: </strong>This trial is designed to evaluate the effectiveness of Braun anastomosis in reducing delayed gastric emptying after open pancreatoduodenectomy. Throughout the trial, semi-structured interviews will be conducted with surgeons in order to perform a barrier-facilitator analysis, allowing for successful implementation of BE if proven effective.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05709197. Registered on January 24, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"387"},"PeriodicalIF":2.0,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12490083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145213677","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":"Testing the effectiveness of the Responsible, Engaged, and Loving Fathers (REAL Fathers) intervention for improving early childhood development and reducing family violence in Uganda: Study protocol for a cluster-randomized controlled trial.","authors":"Kathryn M Barker, Symon Wandiembe, Anslem Wandega, Joshua Jeong, Dickens Ojamuge, Rebecka Lundgren, Deogratias Yiga, Dennis Nabembezi","doi":"10.1186/s13063-025-09061-9","DOIUrl":"10.1186/s13063-025-09061-9","url":null,"abstract":"<p><strong>Background: </strong>Witnessing and experiencing violence impedes children's healthy development and learning, inhibits positive relationships, provokes low self-esteem and emotional distress, and can lead to self-harm and aggressive behavior across the life course. Evidence-based programs are needed that incorporate violence prevention strategies alongside methods to improve wellbeing and healthy development for children and their families. This trial evaluates the Responsible, Engaged, and Loving Fathers (REAL Fathers) intervention, a Ugandan-led multilevel community-based mentoring program for young fathers (ages 16-25) with children below the age of three years.</p><p><strong>Methods: </strong>To assess the REAL Fathers intervention, we use a cluster-randomized controlled trial design within 48 sub-counties randomly sampled from 24 districts in six regions of Uganda. Sub-counties were randomly allocated to treatment or control arms at baseline. Study participants are fathers ages 16-25 years and their cohabitating wives whose eldest child is below the age of 3 years (n = 3744 couple dyads). Primary outcomes are the following: (1) reduced intimate partner violence; (2) reduced violent discipline of children; (3) increased father-child engagement and play; (4) improved early childhood development. Secondary outcomes include the following: (1) father's knowledge of and (2) attitudes towards positive parenting and discipline; (3) father's use of positive parenting and discipline; (4) father's use of emotional engagement with child; (5) couple communication and conflict resolution; (6) gender equitable household and caregiving decision-making and behaviors; (7) father engagement in child health-promoting activities; (8) improved knowledge of family planning methods; (9) reduced unmet need for family planning; (10) reduced problem alcohol use; and (11) supportive community norms for father-child engagement and play. Longitudinal survey data will be collected by trained enumerators using KoboCollect in six local languages at three time points: one month before the intervention (baseline); one month after the intervention (endline); and nine months after the intervention (follow-up). Intervention effects on primary and secondary outcomes will be assessed using difference-in-differences (DiD) mixed-effects models that account for the clustered design.</p><p><strong>Discussion: </strong>This trial will examine the impacts of a multilevel community-based intervention for young fathers and their families in Uganda on positive parenting, childhood development, and violence reduction. Overall, successful completion of this study will contribute to the evidence-based on context-informed multilevel approaches that reduce harm and promote wellbeing in families with very young children.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov #NCT06100679. Registered on October 24, 2023. https://clinicaltrials.gov/study/NCT06100679 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"372"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482192/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193112","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 CoolCot trial: active methods of therapeutic hypothermia for newborns with hypoxic ischaemic encephalopathy (HIE) during neonatal transport: a study protocol for a randomised controlled trial comparing battery-enabled servo-controlled cooling blankets and ice-gel pack methods.","authors":"Adam Heathcote, Kate Hooper, Matt Cooper, Sebastian Lee, Fan Tang, Vamsi Batta, Saumil Desai, Jacqueline Gardiner, Alex Wilson, Kylie McDonald, Alysha Timoney, Tess Watson, Jonathan Davis","doi":"10.1186/s13063-025-09111-2","DOIUrl":"10.1186/s13063-025-09111-2","url":null,"abstract":"<p><strong>Background: </strong>Impaired oxygen delivery or blood flow to the brain around the time of birth can cause injury. Hypoxic ischaemic encephalopathy (HIE) is a leading cause of death and disability in term and near-term infants. Therapeutic hypothermia (TH) (reducing body temperature to 33-34 °C for 72 h after birth) is the only intervention available for infants with moderate-to-severe encephalopathy. TH should be initiated within 6 h of birth for maximum benefit. Many infants worldwide are not born in a centre where TH is possible, and transport is required for active TH. In Australia, the current method of active TH during transport involves ice-gel packs. There have been no prospective studies comparing active methods of TH in neonatal transport reporting short- and long-term outcomes. We aim to compare two active TH modalities: a battery servo-controlled cooling device and infant wrap (Criticool Mini and Cruewrap (Belmont Medical Technologies, MA, USA)) and standard care (ice-gel packs) for TH during the transport of newborns with HIE.</p><p><strong>Methods: </strong>The CoolCot study will be conducted in the Newborn Emergency Transport Service of Western Australia (NETS WA), a single state-wide transport service. Eligible infants with confirmed or suspected HIE will be referred to NETS WA from healthcare facilities without tertiary health (TH) capacity in Western Australia. Following the arrival of the transport team, infants with informed consent will be randomly assigned to battery-enabled servo-controlled TH or standard care (ice-gel packs). The primary outcome will be the proportion of patients with a temperature in the range of 33.0-34.0 °C on arrival at the receiving unit. The secondary outcomes include the time to achieve the therapeutic temperature, the time spent out of the temperature range, the degree of temperature fluctuation and safety. Long-term measures: MRI brain findings (days 5-10 of life) and Bayley Scales of Infant Development assessment at 2 years.</p><p><strong>Discussion: </strong>The CoolCot study is the first RCT to prospectively compare the effectiveness of active cooling methods in neonatal emergency transport. Reducing the time needed to achieve the target temperature is crucial in optimising neurodevelopmental outcomes. A key feature of this study is the neurodevelopmental assessment conducted at age two.</p><p><strong>Trial registration: </strong>WHO ICTRP Registry/Australian New Zealand Clinical Trials Registry: ACTRN12623001298606p. The CoolCot trial was prospectively registered on 13th December 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"375"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482170/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193128","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":"DIZZiness treatment through implementation and clinical strategy Tactics-2 (DIZZTINCT-2) project-a clinical trial protocol.","authors":"William J Meurer, Stacy Park, Huong Nguyen, Silvia R Paz, Molly O Jancis, Julliane Bacerdo, Aileen S Baecker, Prasanth Manthena, Navdeep S Sangha, Chengyi Zheng, Lawrence C An, Terry D Fife, Adam L Sharp, James F Burke, Kevin A Kerber","doi":"10.1186/s13063-025-09055-7","DOIUrl":"10.1186/s13063-025-09055-7","url":null,"abstract":"<p><strong>Background: </strong>The evaluation and management of acute vertigo presentations is challenging for both patients and physicians. Benign paroxysmal positional vertigo (BPPV), acute unilateral vestibulopathy (e.g., vestibular neuritis), and stroke are priority diagnostic considerations in this circumstance. Existing evidence can be used to guide the diagnosis and treatment, however high value care opportunities-such as the Dix-Hallpike test (DHT), canalith repositioning maneuver (CRM), and gaze stabilization exercises (GSE)-are often underused, while neuroimaging studies are often overused.</p><p><strong>Methods: </strong>This trial contains a health system focused stepped wedge intervention and an embedded individually patient randomized clinical trial. The study will start with a 6-month pre-intervention period. This will be followed by staggered intervention at the engaged EDs in 11 waves and then an approximately 6-month post-intervention period. Concurrently, patients will be recruited before and after the physician level intervention is implemented at each ED. Enrolled participants will complete baseline survey and then be randomized individually, stratified by sex, age, and medical center, to the intervention or control arm patient materials using central computerized randomization. The intervention arm will be sent intervention materials and the control arm will be sent the hospital's standard post-discharge materials. The primary outcome of the physician-based part of the trial is use of evidence-based care practices during the index ED visit. The primary outcome of the patient focused part of the trial is the dizziness handicap index over 4 weeks.</p><p><strong>Discussion: </strong>The DIZZTINCT-2 trial addresses key areas of uncertainty in how to improve the care of emergency department patients with acute vertigo. In addition, follow up data on how much and how fast patients improved was needed. DIZZTINCT-2 will address these key knowledge gaps efficiently.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov NCT05634902. Registered on November 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"378"},"PeriodicalIF":2.0,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482680/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145193028","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}