Trials最新文献

{"title":"Effects of olfactory enrichment on perioperative neurocognitive disorders in elderly patients undergoing orthopedic surgery: a study protocol of a multi-center randomized controlled trial.","authors":"Xinchun Mei, Jiayi Wang, Zihan Ni, Yanyan Wang, Binglei Zhao, Daniel I Sessler, Zhongcong Xie, Yuan Shen","doi":"10.1186/s13063-025-09109-w","DOIUrl":"10.1186/s13063-025-09109-w","url":null,"abstract":"<p><strong>Background: </strong>Neurocognitive disorders are prevalent among older surgical patients, yet their underlying mechanisms and effective interventions remain largely unknown. Studies in rodents and patients suggest a connection between olfactory impairment and perioperative neurocognitive disorder (PND). Previous work in mice demonstrates that anesthesia and surgery can lead to both olfactory impairment and cognitive deficits. Olfactory enrichment, which is also referred to as olfactory training (i.e., daily exposure to multiple odorants), may prove helpful. For example, olfactory enrichment appears to reduce PND-like behaviors in mice, possibly by mitigating anesthesia- and surgery-induced reductions in olfactory receptor neurons. Additionally, olfactory enrichment increases the volume and size of olfactory-related brain regions, such as the olfactory bulb and hippocampus, as well as changes in functional connectivity in non-surgical adults. Despite promising findings in mice, it remains unknown whether olfactory training reduces PND in surgical patients. We therefore propose a randomized clinical trial.</p><p><strong>Methods and analysis: </strong>This sham-controlled assessor-blind randomized controlled trial will enroll 686 patients aged 65 and older who are scheduled for orthopedic Surgery expected to last at least 2h under general anesthesia. Participants will be randomized 1:1 to olfactory enrichment or sham treatment. Those assigned to the olfactory enrichment group will receive twice-daily 30-min sessions involving four distinct odors, beginning on 1 day before surgery and continuing for three postoperative days during hospitalization. Patients assigned to sham treatment will follow the same schedule, but with odorless substances in the scent dispenser. The primary outcome is the incidence of postoperative delirium, assessed using the 3-min diagnostic interview for CAM-defined delirium (3D-CAM) on postoperative days 1, 2, and 3. Secondary outcomes include the incidence of delayed neurocognitive recovery and postoperative neurocognitive disorder, evaluated through cognitive function assessments using neuropsychological tests at baseline, 21 days, and 6 months after the anesthesia/surgery. Exploratory outcomes include the severity of delirium measured by the CAM-severity (CAM-S) tools, the severity of delayed neurocognitive recovery and postoperative neurocognitive disorder assessed through neuropsychological tests, evaluations of activities of daily living, plasma Tau-PT217 levels, and olfactory function.</p><p><strong>Discussion: </strong>This is the first clinical trial to evaluate the efficacy of olfactory enrichment in geriatric patients undergoing orthopedic surgery, filling an important gap in the treatment evidence for PND.</p><p><strong>Trial registration: </strong>The trail has been registered in ClinicalTrial.gov with the Trial Registration Number of NCT06488807. Date of registration in the primary registry: June 15, ","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"363"},"PeriodicalIF":2.0,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465810/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178984","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":"Coenrollment of critically ill patients in PROSPECT: characteristics and association with treatment efficacy and safety.","authors":"Alex Thabane, Diane Heels-Ansdell, Nicole Zytaruk, Jennie Johnstone, François Lauzier, Yaseen M Arabi, John Muscedere, France Clarke, Lori Hand, Irene Watpool, Rebecca Porteous, Gyan Sandu, Marlene Santos, Danae Tassy, John Marshall, Lauralyn McIntyre, Ian Ball, Bram Rochwerg, Tim Karachi, Ryan Zarychanski, Francois Marquis, Jan O Friedrich, Paul Lysecki, Deborah Cook","doi":"10.1186/s13063-025-09028-w","DOIUrl":"10.1186/s13063-025-09028-w","url":null,"abstract":"<p><strong>Introduction: </strong>Coenrollment is the enrollment of one participant into more than one study. While coenrollment can enhance research efficiency, it theoretically may result in treatment interactions that distort effect estimates. This study aimed to explore the sensitivity of safety and efficacy outcomes to coenrollment in an international, blinded randomized controlled trial evaluating probiotic use in critically ill patients (PROSPECT: Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial; [NCT02462590]).</p><p><strong>Methods: </strong>In this planned secondary analysis of PROSPECT, we performed Cox proportional hazards analyses to assess the sensitivity of the treatment effect of probiotics to coenrollment on the primary outcome of ventilator-associated pneumonia. Secondarily, we examined the characteristics of coenrolled patients, studies, and centers using descriptive statistics, explored factors associated with coenrollment via a multilevel logistic regression model, and conducted Fisher's exact tests to evaluate the difference in adverse event rates (defined as Lactobacillus species from a sterile site or cultured as the sole or predominant organism from a nonsterile site) by coenrollment status.</p><p><strong>Results: </strong>Of 2650 PROSPECT participants recruited across 44 centers, 568 patients (21.4%) were coenrolled a total of 680 times across 115 studies. Coenrollment did not modify the effect of probiotics on the primary outcome of ventilator-associated pneumonia (p = 0.630). Patients who were coenrolled in any other study had a higher rate of adverse events compared to non-coenrolled patients (p = 0.011); however, post hoc testing found no difference in adverse events between patients coenrolled specifically into at least one other randomized controlled trial and patients who were not coenrolled into another randomized controlled trial (i.e., coenrolled into an observational study or not coenrolled at all; p = 0.126). Multivariable analyses found more severely ill patients (p = 0.038) and patients from centers with a longer PROSPECT recruitment period (p = 0.047) were more likely to be coenrolled.</p><p><strong>Conclusion: </strong>In this international, blinded trial, one-fifth of patients enrolled were coenrolled in at least one other study, which had no influence on the effect of probiotics on the primary outcome. Coenrolled patients were more likely to have higher disease severity, and to be recruited from a center with a longer history of participation in PROSPECT.</p><p><strong>Trial registration: </strong>The PROSPECT trial was registered in ClinicalTrials.gov NCT02462590. Registered on June 2015.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"370"},"PeriodicalIF":2.0,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178983","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":"Use of routinely collected health data (England) to identify subsequent disease-related events in patients with primary breast cancer: a practical alternative to hospital-based follow-up for breast cancer clinical trials.","authors":"Lucy S Kilburn, Victoria Hinder, Sikhuphukile G Mahati, Judith M Bliss","doi":"10.1186/s13063-025-09085-1","DOIUrl":"10.1186/s13063-025-09085-1","url":null,"abstract":"<p><strong>Background: </strong>With continued improvements in breast cancer (BC) outcomes and risk of recurrence occurring until at least 20 years post-diagnosis, it is important to continue to follow up clinical trial participants to characterise long-term treatment impact. Traditionally, follow-up has been via hospitals, entailing burden on patients and site staff. Using routinely collected health datasets (RCHD) as an alternative method is attractive, but historically, cancer recurrence is poorly recorded, unlike initial cancer diagnosis. Here we use data collected prospectively from large, multi-centre BC clinical trials to develop and test a procedure to identify recurrence within RCHD.</p><p><strong>Methods: </strong>Data from four trials of early breast cancer (TACT2, POETIC, IMPORT-HIGH and FAST-Forward) where recurrence data has been collected prospectively (gold standard) was linked with RCHD (incl. cancer registry and hospital episode statistics; HES) managed by NHS England. The procedure identified episodes of clinical activity within RCHD to classify each event type (local and distant recurrence, second cancers, death) separately, then combined to derive time-to-recurrence (TTR), disease-free survival (iDFS) and overall survival (OS) outcomes. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated. Hazard ratios using Cox regression modelling, log-rank test p-values, and 3-year survival rates for the randomised treatments were reported separately for RCHD and trial data.</p><p><strong>Results: </strong>The final procedure used Cancer Registry diagnoses to identify initial BCs for quality control purposes and second primary cancers. Deaths were identified via death dates and cause. Distant recurrence was identified predominantly by direct indicators of metastases (e.g. ICD10 codes C77X-79X). Local recurrence was identified via relevant surgeries' OPCS4 codes. For TTR, iDFS and OS, agreement between study and RCHD events was reasonable. Specificity was good across all endpoints (range: 97.9-99.9% for three training datasets combined), as was NPV (range: 95.2-99.6%). Sensitivity and PPV were more variable, with sensitivity ranging between 72.9 and 97.2% and PPV ranging between 82.6 and 99.5%. Values were similar when considering the test dataset. Survival estimates for TTR, iDFS and OS were similar between study and RCHD data.</p><p><strong>Conclusion: </strong>It is possible, with reasonable accuracy, to identify cancer recurrences using RCHD in the place of hospital-based data collection after the point of primary analysis.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"359"},"PeriodicalIF":2.0,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465273/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179132","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":"Why do common sense trials fail in the UK? Lessons learned from a trial which tested the effectiveness and cost-effectiveness of a community falls prevention programme (the Firefli study).","authors":"Joy Adamson, Arabella Scantlebury, Avril Drummond, Caroline Fairhurst, Sarah Cockayne","doi":"10.1186/s13063-025-09116-x","DOIUrl":"10.1186/s13063-025-09116-x","url":null,"abstract":"<p><strong>Background: </strong>The Firefli study was funded from a commissioned call to conduct a individually randomised controlled trial to assess the effectiveness and cost-effectiveness of Home Fire Safety Visits (also known as Safe and Well Visits) in their ability to reduce falls and improve quality of life in older adults living in the community. These visits are routinely carried out by fire and rescue services in England and aim to reduce risk of fire, support independent living and improve quality of life. In this paper, we reflect on our experience of attempting to deliver a definitive trial within the fire service, with the aim of informing future commissioning and methodological practice for non-National Health Service hosted trials in the UK.</p><p><strong>Lesson learned: </strong>It proved impossible to conduct the trial as planned in the current research landscape, randomising only 63 participants from a target of 1156. Whilst there were challenges associated with the COVID-19 pandemic, it was key issues pertaining to current regulatory requirements, the acquisition of data and lack of research culture and infrastructure with the fire service which were fundamental barriers to successful research delivery. Specifically, these barriers meant it was not feasible to implement the trial as designed to reflect actual service delivery. The adapted trial design had very low recruitment and resulted in differences between the target population and the trial population.</p><p><strong>Conclusions: </strong>Conducting trials outside of health is extremely challenging in the UK. We recommend an urgent review of research governance processes which are primarily designed for health-related research in the National Health Service and are not fit for purpose when conducting research within other sectors. Many of the challenges identified are not exclusive to delivering trials in the fire service and have wider implications as the scope for evidence-based practice expands outside of health.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT04717258.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"365"},"PeriodicalIF":2.0,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465928/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179143","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":"Hypothermic oxygenated perfusion (HOPE) against cancer recurrence after liver transplantation for hepatocellular carcinoma-study protocol for an international multicenter randomized controlled trial (HOPE4Cancer).","authors":"Janina Eden, Philip C Müller, Christoph Kuemmerli, Florian Peters, Tanja Litke, Anne Kranich, Andreas E Kremer, Stefanie von Felten, Philipp Dutkowski","doi":"10.1186/s13063-025-09120-1","DOIUrl":"10.1186/s13063-025-09120-1","url":null,"abstract":"<p><strong>Background: </strong>A frequent and increasing indication for liver transplantation (LT) is hepatocellular carcinoma (HCC). However, despite strict selection criteria, HCC recurrence after LT occurs in a relevant proportion of patients and is associated with an unfavorable prognosis. Hypothermic oxygenated perfusion (HOPE) is a novel machine liver perfusion approach to optimize liver grafts before implantation and has been suggested to decrease graft inflammation with potential anti-cancer effects.</p><p><strong>Methods: </strong>HOPE4Cancer is an international, multicentric, parallel group, randomized controlled trial comparing HOPE performed after initial cold storage (intervention) with conventional cold storage alone (control) in a 1:1 allocation ratio. Adult recipients with proven HCC will be included for transplantation of a DBD (donation after brain death) Liver graft. The minimum perfusion duration is defined at 2 h and perfusion is generally continued until the recipient hepatectomy is completed. The conventional cold storage at 4 °C will be performed with a precooled preservation solution according to the local standard of care. The primary endpoint is defined as post-transplant HCC recurrence-free survival, i.e., the time interval a patient is alive without HCC recurrence after transplantation. Secondary endpoints are the single components of the events considered for the primary outcome (i.e., HCC recurrence, HCC-related death, death from any other causes than HCC), circulating tumor DNA, high-mobility-group-protein B1 in the blood, the Rejection Activity index, and the number of liver-related complications experienced by the patient.</p><p><strong>Discussion: </strong>HOPE4Cancer investigates if cold storage plus end-ischemically applied HOPE in DBD LT is superior to conventional cold storage of liver grafts in terms of post-transplant HCC recurrence-free survival. The results will indicate for the first time whether ex situ HOPE before transplant has an anti-cancer potential compared to transplantation of un-perfused livers.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06717919. Registered on December 5, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"369"},"PeriodicalIF":2.0,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465341/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179005","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 randomized controlled trial of Internet-delivered guided and unguided cognitive behaviour therapy for treating depression and anxiety in UK university students: study protocol for the Nurture-U Internet CBT trial.","authors":"E R Watkins, D Phillips, H Choueiri, A Ford, H Cook, G Taylor, R C Kessler","doi":"10.1186/s13063-025-09023-1","DOIUrl":"10.1186/s13063-025-09023-1","url":null,"abstract":"<p><strong>Background: </strong>Tackling poor mental health in university students is a priority in higher education. Although major depressive disorder and generalized anxiety disorder are highly prevalent among university students and predict impaired university and later life outcomes, most students do not receive evidence-based treatment. Internet-delivered cognitive-behavioural therapy (iCBT) is increasingly offered to UK university students in guided or unguided formats. Our aim is to compare the effects of guided versus unguided scalable iCBT for university students with elevated symptoms of depression and/or anxiety and to investigate the feasibility of creating individual treatment rules (ITR) to predict for whom which variant of iCBT is more effective as well as for whom neither is effective.</p><p><strong>Methods: </strong>An online single-blind, two-arm parallel-group randomized controlled trial to examine symptoms of depression and anxiety across 3 months in university students aged over 16 who screen into the study with self-reported high levels of anxiety (GAD-7 > 9) and/or depression (PHQ-9 > 9). Eligible participants will be randomized to guided transdiagnostic iCBT supported by a psychological wellbeing practitioner or to the same transdiagnostic iCBT content as unguided self-help. In total, 720 participants with no current bipolar disorder or psychosis will be recruited from UK universities. Assessments will take place at baseline (pre-randomization) and 3 months post-randomization. Primary endpoints and outcomes are self-reported depression and anxiety symptoms at 3-month follow-up, adjusting for baseline scores. Well-being, health-related quality of life, functioning and academic outcomes are secondary outcomes. Compliance, adverse events, and potentially mediating variables will be monitored. We will use machine learning to estimate heterogeneity of treatment effects and develop an ITR to optimize the allocation of students to either unguided or guided iCBT.</p><p><strong>Discussion: </strong>The trial aims to provide a better understanding of the relative benefits of guided and unguided iCBT for anxiety and depression in university students with considerable implications for treatment coverage and service planning and delivery. We will provide innovative information to optimize treatment assignment, guide university mental health treatment planning and support evidence-based and scalable interventions for the most common mental health problems in university students.</p><p><strong>Trial registration: </strong>ISRCTN: 56784470, https://www.isrctn.com/ISRCTN56784470 . Registered on 27 October 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"366"},"PeriodicalIF":2.0,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465736/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145178985","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":"PReventing Injury in Skilled nursing facilities through optimizing Medications (PRISM), a protocol for a cluster randomized trial to reduce injurious falls in post-acute care.","authors":"Sarah D Berry, Mark Toles, Thomas G Travison, Eleanor S McConnell, Andrew R Zullo, Milta O Little, Lisa Gwyther, Cara McDermott, Richard Lee, Michael Cary, Maggie Syme, Stephanie Kissam, Emily Hecker, Kylee G MacLean, Cathleen Colón-Emeric","doi":"10.1186/s13063-025-09122-z","DOIUrl":"10.1186/s13063-025-09122-z","url":null,"abstract":"<p><strong>Background: </strong>Patients who receive post-acute care in a skilled nursing facility (SNF) following a fracture are at high risk for subsequent fall-related injuries. Optimizing medication management may mitigate this risk. This manuscript describes the protocol for a cluster crossover randomized controlled trial titled, PReventing Injury in Skilled Nursing Facilities through optimizing Medications (PRISM), designed to compare the effectiveness of three care models on the rates of injurious falls and other patient-centered outcomes.</p><p><strong>Methods: </strong>We will enroll 42 SNFs that are sharing electronic health record data with the Long-Term Care Data Cooperative (LTCDC). Matched control facilities will be identified at a ratio of 3:1 based on rural/urban location, profit status, and annual number of post-acute care admissions. Over 6-month periods, in random order, the participating SNFs will sequentially implement three evidence-based care models in a random order: a Deprescribing model, a Bone Health model, and a combined model (referred to as an Injury Prevention model). Patients with recent fractures admitted to participating SNFs for post-acute care during the intervention period will be eligible (target n = 3780). A remote nurse fracture consultant will review medical records, engage in shared decision-making, develop and coordinate a medication optimization plan with SNF and primary care providers, and follow up with the patient and primary care provider upon discharge. The primary outcome is incident injurious falls, measured using Medicare claims data (mean 2-year follow-up). Secondary outcomes include process measures (e.g., adherence with recommendations) and patient-reported outcomes ascertained by telephone survey at 90 days (e.g., medication burden, anxiety, depression, pain, sleep). Safety outcomes will be compared between the three models using Medicare claims data to identify events.</p><p><strong>Discussion: </strong>This cluster crossover trial aims to compare patient outcomes between each of the three care models and against matched control facilities. Results will inform patients, payors, health systems, and SNF chains of the most effective model to improve outcomes for older adults receiving post-acute care following a fracture.</p><p><strong>Trial registration: </strong>NCT06304428. Registered on February 25, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"367"},"PeriodicalIF":2.0,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465586/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179047","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 low-dose esketamine on hypoxemia during gastroscopy in patients with moderate-to-high risk obstructive sleep apnea: protocol for a prospective, randomized, controlled trial.","authors":"Xin-Ming Li, Si-Qi Hao, Xiu-Ru Qi, Dan-Dan Hao, Ying Li, Li-Xin An","doi":"10.1186/s13063-025-09098-w","DOIUrl":"10.1186/s13063-025-09098-w","url":null,"abstract":"<p><strong>Background: </strong>Propofol sedation in patients with Obstructive Sleep Apnea (OSA) frequently induces hypoxemia, posing significant clinical risks. Esketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, may reduce propofol requirements while preserving respiratory stability, but its efficacy in OSA patients remains unproven. At the studied dose (0.25 mg/kg), esketamine's potential side effects (transient hypertension) are expected to be mild and self-limited. Therefore, we aimed to test whether low-dose esketamine (0.25 mg/kg) can reduce the incidence of hypoxemia in moderate-to-high risk OSA patients during propofol-based painless gastroscopy.</p><p><strong>Methods: </strong>This single-center, double-blind, randomized controlled superiority trial will enroll 294 patients (STOP-Bang score ≥ 3, 18-90 years, STOP-Bang = Snoring, Tiredness, Observed apnea, Pressure [blood], Body Mass Index [BMI], Age, Neck size, Gender.) undergoing gastroscopy. Participants will be randomized 1:1 to receive either esketamine (0.25 mg/kg) plus propofol or saline placebo plus propofol, stratified by age (18-65 vs. > 65 years) and OSA severity (STOP-Bang 5-6 vs. ≥ 7). The primary outcome is the incidence of hypoxemia (Peripheral Oxygen Saturation [SpO₂] < 90% for > 10 s). Secondary outcomes include severe hypoxemia (SpO₂ ≤ 75% or ≤ 90% for ≥ 60 s), duration of hypoxemia, emergency airway management, propofol consumption, hemodynamic stability, involuntary body movements, procedure/recovery times, and clinician satisfaction (measured via 10-cm Visual Analog Scale [VAS]).</p><p><strong>Discussion: </strong>This protocol rigorously evaluates esketamine's potential to improve sedation safety in OSA patients, addressing a critical gap in peri-procedural care.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry (ChiCTR2500099420). Registered on March 24, 2025 (Supplementary File 2). Si-Qi Hao is a co-first author with the same contribution as the first author. The corresponding author is Li-Xin An.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"364"},"PeriodicalIF":2.0,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145179035","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":"Base curves of bandage contact lenses and their effects on post Trans-PRK vision and pain: the study protocol for a randomized clinical trial.","authors":"Gengmin Tong, Yuanhui Jin, Hangshuai Zhou, Yanhua Jin","doi":"10.1186/s13063-025-09115-y","DOIUrl":"10.1186/s13063-025-09115-y","url":null,"abstract":"<p><strong>Background: </strong>Transepithelial photorefractive keratectomy (Trans-PRK) is an effective and safe laser surgery for myopia. Following this procedure, a bandage contact lens is used to promote epithelial healing, reduce postoperative pain, and improve visual recovery. The base curve of these lenses may affect vision post-surgery, particularly in patients with steep corneas and high myopia. This study aims to investigate the impact of using bandage contact lenses with base curves of 8.4 mm versus 8.8 mm on visual recovery after Trans-PRK in patients with steep corneas and high myopia.</p><p><strong>Methods: </strong>This is a randomized, double-blind, binocularly controlled, single-center trial. The study subjects are myopic patients scheduled for Trans-PRK. Both eyes in each patient will be treated consecutively with single-step Trans-PRK. After surgery, a contact lens with an 8.8-mm base curve will be placed on one eye, and a lens with an 8.4-mm base curve will be placed on the other. The primary objective is to determine the difference in early postoperative uncorrected visual acuity between the two eyes of patients with steep corneas and high myopia. Randomization will be conducted using a computer-generated random allocation sequence without blocks or restrictions. The sequence will be recorded in sealed opaque envelopes, maintained by the principal investigator until the trial's conclusion. In this double-masked trial, subjects will not know which treatment each eye receives.</p><p><strong>Discussion: </strong>This novel trial will provide information on how bandage contact lenses with different base curves promote epithelial healing and visual recovery after Trans-PRK, thus offering evidence for clinical practice.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06393855. Registered on May 1, 2024. https://clinicaltrials.gov/study/NCT06393855 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"357"},"PeriodicalIF":2.0,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465201/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145150772","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":"Effect of a continuous care model-based program on fatigue, self-efficacy, and quality of life in patients with Parkinson's disease: study protocol for a randomized controlled trial.","authors":"Mahshid Ebrahimiyan Tadi, Shahla Abolhassani, Fatemeh Nazari, Ahmad Chitsaz","doi":"10.1186/s13063-025-09057-5","DOIUrl":"10.1186/s13063-025-09057-5","url":null,"abstract":"<p><strong>Background: </strong>Neurological disorders, including Parkinson's disease (PD), are among the leading causes of disability worldwide. One of the major challenges of this disease is chronic fatigue, which is considered one of the most common and debilitating non-motor symptoms. Increased fatigue in these patients reduces their self-efficacy, which directly correlates with decreased quality of life (QOL) and worsening motor and non-motor symptoms. Given the profound impact of PD on patients' daily lives, adopting effective approaches to improve their QOL is essential. The continuous care model (CCM), designed as an indigenous approach based on Iran's cultural and social characteristics, can serve as an effective strategy for managing complications associated with PD.</p><p><strong>Methods: </strong>This study is a clinical trial aimed at evaluating the effect of the CCM on fatigue, self-efficacy, and QOL in patients with PD in Isfahan, Iran. A total of 80 patients will be selected through convenience sampling and randomly assigned to either the intervention or control group. Data will be collected using standardized questionnaires at three time points: before the intervention, immediately after, and 1 month later. In the intervention group, the CCM will be implemented over a nine-week period in four stages: familiarization, sensitization, control, and evaluation. The control group will receive only routine pharmacological care. Data will be analyzed using descriptive statistics (mean and standard deviation), followed by repeated measures ANCOVA to compare changes in outcomes across three time points between groups, controlling for covariates. Normality and homogeneity of variances will be assessed using the Kolmogorov-Smirnov and Levene's tests, respectively.</p><p><strong>Discussion: </strong>Various approaches have been proposed to manage fatigue, enhance self-efficacy, and improve QOL in patients with PD; however, many of these strategies face challenges, including the lack of a comprehensive approach. The CCM focuses on the care of patients with chronic conditions, emphasizing education and empowerment for both patients and their families. By placing the patient at the center of care, this holistic approach plays a crucial role in the management of chronic diseases.</p><p><strong>Trial registration: </strong>It is registered in the Iranian Registry of Clinical Trials (IRCT) with the registration number IRCT20190712044181N7.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"355"},"PeriodicalIF":2.0,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465541/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145150982","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}