Contemporary Clinical Trials Communications最新文献

{"title":"MiBUP: A pilot randomized controlled trial of low-dose initiation of buprenorphine for opioid use disorder: Design and rationale","authors":"Benjamin T. Hayes ,&nbsp;Annika Sabado ,&nbsp;Haruka Minami ,&nbsp;Chenshu Zhang ,&nbsp;Matthew Holm ,&nbsp;Laila Khalid ,&nbsp;Tiffany Y. Lu ,&nbsp;Kristine Torres-Lockhart ,&nbsp;Aaron D. Fox","doi":"10.1016/j.conctc.2026.101594","DOIUrl":"10.1016/j.conctc.2026.101594","url":null,"abstract":"<div><h3>Background</h3><div>Buprenorphine is an effective treatment for opioid use disorder (OUD), however withdrawal during initiation is a barrier. Low-dose initiation (LDI) involves starting very small doses of buprenorphine overlapping with opioids to avoid withdrawal. This pilot study aims to evaluate the feasibility of a randomized controlled trial (RCT) comparing buprenorphine LDI versus standard initiation among ambulatory patients with OUD.</div></div><div><h3>Methods</h3><div>This is a pragmatic parallel-group open-label pilot RCT of LDI versus standard initiation in ambulatory settings. LDI arm: starts with 0.5–0.125 mg of sublingual buprenorphine-naloxone films daily, titrating to a therapeutic dose over eight days. Standard arm: participants achieve moderate withdrawal before beginning with 4–1 mg. Therapeutic target in both arms:16-4 mg to 32-8 mg. A total of 70 adults (18 years or older) with any severity of OUD will be recruited. Key exclusion includes currently taking medication treatment for OUD, severe alcohol or benzodiazepine use disorder, severe mental illness, and pregnancy. The primary outcome: feasibility of recruiting primary care patients with OUD to a clinical trial of LDI, measured as percent of assessed participants who enroll in the study. Key secondary outcomes: LDI protocol feasibility, meaning compliance to the protocol (i.e., starting with less than 1 mg of buprenorphine and taking increasing dosages daily); preliminary effectiveness of treatment uptake at a two-week study visit, confirmed by a urine drug test positive for buprenorphine; six-week treatment retention measured by pharmacy-dispensed buprenorphine; and safety outcomes.</div></div><div><h3>Discussion</h3><div>As a pilot clinical trial this study will inform design of a fully powered RCT to test buprenorphine LDI in the ambulatory setting.</div><div><em>Trial registration</em> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, NCT05450718: date of registration: June 22, 2022; <span><span>https://clinicaltrials.gov/study/NCT05450718?term=NCT05450718&amp;rank=1</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101594"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145926663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Strategic risk assessment in oncology: Utilizing single-agent activity to boost combination therapy approvals","authors":"Adetayo Kasim ,&nbsp;Marina Anastasiou ,&nbsp;Evangelia Loizou ,&nbsp;Andreas Dimakakos ,&nbsp;Maria Georganaki ,&nbsp;Ioannis Mourelatos ,&nbsp;Panos Karelis ,&nbsp;Marianna Esposito ,&nbsp;Helen Zhou ,&nbsp;Tai-Tsang Chen ,&nbsp;Dimitrios Skaltsas ,&nbsp;Paul Stockman","doi":"10.1016/j.conctc.2025.101590","DOIUrl":"10.1016/j.conctc.2025.101590","url":null,"abstract":"<div><h3>Background</h3><div>This study examines whether single-agent activity in early clinical phases correlates with the approval likelihood of combination therapies in oncology. Using the Intelligencia AI database, we investigated the impact of monotherapy efficacy on the success rates of combination therapies.</div></div><div><h3>Methods</h3><div>The analysis included combinational therapies across various solid tumor types, assessing the approval rates and the presence of monotherapy efficacy with cut-off date September 12, 2024, and an assessment of 3896 programs. We analyzed historical clinical trial data focusing on Objective Response Rate (ORR) as a metric of single-agent activity (SAA).</div></div><div><h3>Results</h3><div>Approval rate for combination programs across all indications and phases was 4.2 %. Programs that included approved monotherapy drugs had an approval rate of 6.1 %, whereas those without approved monotherapy drugs had a lower approval rate of 2.7 %. However, the historical approval rate for combination programs with failed monotherapy drug with more than 20 % objective response rate was 5.8 %. Furthermore, approved combinations derived from monotherapy-failed pipelines showed diverse ORR thresholds, with specific trends observed across different cancer types.</div></div><div><h3>Conclusions</h3><div>The likelihood of approval for combination therapies is higher when combined with monotherapy drugs that have previously shown single agent activity. This finding is consistent with other research on historical approval rates and the common consensus within oncology drug development. Here we suggest that by leveraging monotherapy drug activity there can be an enhanced prioritization of anti-cancer agents repurposed for combination therapies, which would have otherwise been shelved based on their single agent failure.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101590"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145926727","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study of Chemosensory Enhancement through Neuromodulation Training (SCENT): Design and methodology of a randomized clinical trial for COVID-related persistent smell dysfunction","authors":"Nicole Cash ,&nbsp;Mary Clare Koebel ,&nbsp;Bashar W. Badran ,&nbsp;Aicko Y. Schumann ,&nbsp;Lisa M. McTeague ,&nbsp;Thomas W. Uhde ,&nbsp;Rodney J. Schlosser ,&nbsp;Bernadette M. Cortese","doi":"10.1016/j.conctc.2025.101582","DOIUrl":"10.1016/j.conctc.2025.101582","url":null,"abstract":"<div><h3>Background</h3><div>Few evidence-based treatments exist for COVID-related persistent smell dysfunction. While smell/olfactory training (ST) has emerged as a widely prescribed, first line treatment, rigorous study is required to determine its efficacy in Long COVID. Additional study and development of adjunctive methods to improve the efficacy of ST is also needed.</div></div><div><h3>Methods</h3><div>This paper details the study design and methodology for a large, at-home, randomized, controlled trial designed to determine whether ST and/or trigeminal nerve stimulation (TNS)-enhanced ST improves Long COVID-related disturbances in smell function, mood, sleep, and cognition. Adults with COVID-related persistent smell dysfunction (N = 180) will be recruited and randomized to self-administer ST, placebo smell training (PBO), or TNS-enhanced ST daily for 12 weeks. Our primary objectives are to i) determine the efficacy of ST, compared to any natural gain in function, on olfactory-specific deficits, ii) determine the TNS-enhanced effects of ST on olfactory-specific deficits, and iii) determine if TNS-enhanced ST, compared to ST, is also more efficacious in the treatment of other symptoms of Long COVID.</div></div><div><h3>Conclusion</h3><div>Post COVID persistent smell dysfunction and related deficits are relatively common with very few treatment options. Our proposed study will lay the groundwork for further development of ST and TNS as evidence-based treatments for Long COVID.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101582"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145718958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The clinical rollout of a novel intervention for Veterans with persistent post-concussive symptoms: Protocol for a pragmatic 2-site trial of On-TRACC","authors":"Kathleen F. Pagulayan ,&nbsp;Holly K. Rau ,&nbsp;Rishika Das ,&nbsp;Jennifer K. Bambara ,&nbsp;Jeanne M. Hoffman ,&nbsp;Rhonda M. Williams","doi":"10.1016/j.conctc.2025.101584","DOIUrl":"10.1016/j.conctc.2025.101584","url":null,"abstract":"<div><h3>Background and objectives</h3><div>Veterans with a history of mild traumatic brain injury (mTBI) often report persistent post-concussive symptoms (PPCS). Clinical care guidelines recommend psychoeducation as well as assessment and treatment of the prevalent comorbid psychiatric, sleep, and pain conditions known to contribute to and amplify PPCS. The purpose of this site-randomized pragmatic trial is to examine the effectiveness of a novel 5-week cognitive rehabilitation/self-management intervention designed to increase engagement in treatment of comorbid conditions following mTBI evaluation in Veterans with cognitive PPCS.</div></div><div><h3>Methods</h3><div>On-TRACC (Tools for Rehabilitation and Cognitive Care), a 5-session manualized intervention, will be clinically rolled out at two Veterans Health Administration (VHA) Polytrauma sites, in randomized order, approximately a year apart. Veterans who complete a Comprehensive Traumatic Brain Injury Evaluation (CTBIE) after the clinical roll-out will be offered On-TRACC if deemed clinically appropriate by CTBIE clinical providers. Data collected from retrospective review of electronic health records (EHR) will be used to evaluate treatment engagement patterns for one year after CTBIE or one year after completion of On-TRACC for those who engage in the intervention. Participants receiving the On-TRACC intervention (n = 75) will be compared to those who complete the CTBIE but do not receive On-TRACC (n = 75). To evaluate clinical effectiveness and minimize sampling bias, no data will be gathered from participants directly.</div></div><div><h3>Projected outcomes</h3><div>The primary aim is to examine whether On-TRACC participation improves engagement in treatment of secondary conditions recommended by the CTBIE provider.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101584"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145718959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Epilepsy journey 2.0 study design and methods: A randomized trial of an executive functioning intervention for adolescents with epilepsy","authors":"Angela B. Combs ,&nbsp;Janelle L. Wagner ,&nbsp;Heather Huszti ,&nbsp;Shari L. Wade ,&nbsp;Matthew Schmidt ,&nbsp;Stacy Buschhaus ,&nbsp;Jake Scherra ,&nbsp;Sara E. Wetter-Wren ,&nbsp;David Ogundairo ,&nbsp;Christopher Coffey ,&nbsp;Dixie Ecklund ,&nbsp;Emine Bayman ,&nbsp;Sonal Bhatia ,&nbsp;Tracy Glauser ,&nbsp;Kristina K. Hardy ,&nbsp;Avani C. Modi","doi":"10.1016/j.conctc.2026.101605","DOIUrl":"10.1016/j.conctc.2026.101605","url":null,"abstract":"<div><div>Epilepsy is a common neurological condition that presents unique challenges for adolescents. Executive functioning (EF) deficits contribute to suboptimal academic, social, and quality of life outcomes, yet interventions addressing EF in pediatric epilepsy are lacking. One promising intervention is Epilepsy Journey (EJ), a comprehensive e-health, multi-component problem-solving intervention that incorporates self-guided learning modules and telehealth sessions facilitated by a therapist. This paper describes the methodology, advisory board feedback, changes to the original protocol/intervention, and current progress of a multi-site Phase 3 randomized control trial (RCT; EJ 2.0) to improve EF behaviors. Prior to the RCT, an advisory board comprised of six adolescents, two caregivers, two teachers, and two healthcare providers offered feedback on recruitment/retention, measurement selection, and intervention components. For the RCT, adolescents (age 13–17 years) who meet eligibility criteria for EJ 2.0 are randomized into four groups: EJ modules only, EJ telehealth only, EJ modules with telehealth, or a usual epilepsy care group. Participants in each of the three treatment arms learn about and problem-solve aims related to positive thinking, problem-solving, working memory, organization, inhibition, initiation, task/self-monitoring, emotion regulation, and sleep/stress. The goal is to randomize 232 participants across three sites. The EJ 2.0 study has been strengthened through advisory board feedback, and subsequent protocol changes were critical in the successful launch and execution of the trial to-date. Despite a brief funding gap, the study team has made significant progress in early recruitment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101605"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146022842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exploring the efficacy and safety of Antitoxin and Antipyretic Decoction in treating acute respiratory viral infections with Wind-Heat Obstruction of the Exterior and Heat Invading the Lung Defense a study protocol for a randomized controlled trial","authors":"Wen-Han Li ,&nbsp;Dong-Chen Xu ,&nbsp;Xi-Yue Lu ,&nbsp;Jin-Ye Ma ,&nbsp;Fang-Fang Chen ,&nbsp;Hao Wang ,&nbsp;Hao Li ,&nbsp;Zhan-Fei Tan","doi":"10.1016/j.conctc.2025.101585","DOIUrl":"10.1016/j.conctc.2025.101585","url":null,"abstract":"<div><h3>Background</h3><div>Acute respiratory viral infections are the most common diseases affecting the respiratory system. Currently, there is still a lack of specific antiviral drugs targeting various viruses. Traditional Chinese herbal medicine, with its diverse components and multiple therapeutic targets, has emerged as a promising treatment option. \"Antitoxin and Antipyretic Decoction\" (AAD) is a traditional herbal formula that has been reported to effectively reduce fever and alleviate associated symptoms in clinical practice. However, there is insufficient clinical research evaluating AAD for the treatment of acute respiratory viral infections. Therefore, this study is designed to assess the efficacy of AAD in treating acute respiratory viral infections.</div></div><div><h3>Methods</h3><div>This is a single-center, randomized, double-blind, controlled trial. A total of 120 eligible patients will be randomly assigned in a 1:1 ratio to receive either AAD granules or placebo granules. The trial will last for 5 days, with follow-ups on days 3, 6, and 12. The primary outcome is the proportion of participants with complete fever resolution at Day 6. Secondary outcomes include time to complete fever resolution, time to initial fever reduction, use rate and average dose of emergency antipyretic medication, individual symptom scores (fever, fatigue, cough, muscle aches, taste and smell disturbances, diarrhea, nasal congestion, runny nose, headache, and fatigue) as both absolute values and change values, Traditional Chinese Medicine syndrome scores, and viral clearance time. Any adverse events occurring during the trial will be recorded by the researchers. A small-sample prospective pilot study was conducted from August 2024 to October 2024 to test the feasibility of the trial procedures; the main study described in this protocol has not yet commenced.</div></div><div><h3>Discussion</h3><div>This study aims to provide evidence on the efficacy and safety of AAD in the treatment of acute respiratory viral infections.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101585"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145791853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacokinetics, safety and preliminary efficacy study of montelukast in critically ill infants with developing bronchopulmonary dysplasia (PRISM)","authors":"Jason E. Lang ,&nbsp;Daniel Gonzalez ,&nbsp;Chi D. Hornik ,&nbsp;Rachel Greenberg ,&nbsp;Michael O'Shea ,&nbsp;Daniel K. Benjamin Jr. ,&nbsp;Karen Chiswell ,&nbsp;Sophia Waymers ,&nbsp;Matthew Laughon","doi":"10.1016/j.conctc.2026.101609","DOIUrl":"10.1016/j.conctc.2026.101609","url":null,"abstract":"<div><div>Bronchopulmonary dysplasia (BPD) is an inflammatory disease stemming from premature birth and iatrogenic lung injury. BPD is relatively common and frequently fatal; despite this, there are no FDA-approved therapies. Montelukast is increasingly used to treat developing BPD despite scant safety and efficacy data. Infants with developing BPD have high levels of inflammatory leukotrienes; montelukast blocks the cysteinyl leukotriene receptor. Montelukast shows promise due to results from several small BPD studies. For this <em><u>P</u>harmacokinetic and pha<u>r</u>macodynam<u>i</u>c <u>s</u>tudy of <u>m</u>ontelukast in infants with developing BPD (PRISM)</em> trial, we chose the smallest dose and shortest treatment duration that maintained a prospect for direct benefit. PRISM is a randomized, double-blind, placebo-controlled trial (5 sites, n = 28) of 0.75 mg/kg enteral montelukast dosed every 24 h for up to 7 days. Eligible infants (&lt;28 weeks’ gestation, birthweight &lt;1000 g) require mechanical ventilation and supplemental oxygen (FiO2 ≥30%) at age 7 to 28 days of life. The primary outcome will be apparent clearance of montelukast from a population pharmacokinetic analysis; we will also estimate the apparent volume of distribution, half-life, and exposure metrics. Safety will be assessed by comparing all-cause and neuropsychiatric adverse events and laboratory evaluations between treatment and placebo groups. Comprehensive neurodevelopmental evaluations will occur periodically to 24 months of age. Preliminary efficacy will be measured by oxygen saturation index and time on respiratory supports. These data are intended to demonstrate a reassuring initial risk-benefit profile to justify a dose-escalating PRISM2 trial involving a larger cohort of infants with developing BPD.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101609"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146229020","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Plans4Care, a web application providing caregivers personalized solutions to manage dementia-related care challenges: Proof of concept and efficacy trial","authors":"Laura N. Gitlin ,&nbsp;Eric Jutkowitz ,&nbsp;Catherine Piersol ,&nbsp;Sokha Koeuth ,&nbsp;Taylor Sivori ,&nbsp;Melinda J. Webster ,&nbsp;Rachel N. Barnett ,&nbsp;David L. Roth","doi":"10.1016/j.conctc.2026.101603","DOIUrl":"10.1016/j.conctc.2026.101603","url":null,"abstract":"<div><h3>Objective</h3><div>Few dementia caregivers have access to evidence-based support programs. Web applications (app) may address this gap. Plans4Care, a web app, provides caregivers with on-demand personalized solutions to address care challenges. We present results of a proof-of-concept study and describe a trial protocol to test efficacy.</div></div><div><h3>Methods</h3><div>To use Plans4Care, caregivers respond to brief onboarding questions, assess dementia patients’ cognitive function, identify care challenges, and generate “action plans” (personalized strategies). Telehealth sessions with dementia-trained care advisors are available. A proof-of-concept study evaluated a clickable prototype using standardized technology scales to determine if &gt;75 % scored positively on four criteria (acceptability, feasibility, appropriateness, ease-of-use). The fully developed app will be tested in a prospective randomized trial (n = 160 caregivers). Caregivers will be assigned to an immediate treatment or 6-month delayed control group to evaluate short (3, 6-months) and long-term (12-month) outcomes on caregiver wellbeing and healthcare utilization of caregivers and people with dementia. App use patterns and care advisor interactions will be evaluated.</div></div><div><h3>Findings/results</h3><div>Proof-of-concept testing (N = 25 caregivers) resulted in high ratings (100 % achieved for acceptability and feasibility; 80 % for appropriateness; 96 % for usability), supporting full app development. The app contains &gt;100 care challenges, &gt;2700 nonpharmacological strategies, 60+ education-oriented guidance documents, brief how-to videos, novel assessment of cognitive function, an algorithm personalizing strategies to cognitive function and care context, and a care advisor portal. The trial will yield outcome data and utilization patterns to inform commercialization and scaling.</div></div><div><h3>Conclusions</h3><div>Plans4Care addresses a critical gap in dementia care with potential for commercialization and scalability.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101603"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146022746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The exercise and concussion health study (TECHS): Pilot and feasibility protocol","authors":"Emma M. Tinney ,&nbsp;Mark C. Nwakamma ,&nbsp;Goretti España-Irla ,&nbsp;Madeleine Perko ,&nbsp;Ryan Luke Sodemann ,&nbsp;Jacqueline Caefer ,&nbsp;Julia Manczurowsky ,&nbsp;Charles H. Hillman ,&nbsp;Alexandra Stillman ,&nbsp;Timothy P. Morris","doi":"10.1016/j.conctc.2026.101608","DOIUrl":"10.1016/j.conctc.2026.101608","url":null,"abstract":"<div><div>Mild traumatic brain injury (mTBI) is a prevalent neurological condition, affecting millions worldwide, and frequently resulting in persistent cognitive impairment that significantly impacts daily functioning. Current clinical management and recommendations lack evidence based therapeutic interventions, with treatment approaches limited to symptom monitoring and activity modification. Non-pharmaceutical interventions are needed to promote cognitive recovery and mitigate long-term consequences of mTBI. The goal of this randomized control pilot study is to evaluate the feasibility and preliminary efficacy of a symptom-guided and virtually delivered aerobic exercise intervention for improving cognitive function following mTBI. We are conducting a 12-week pilot randomized control trial of exercise to promote recovery from mTBI, which aims to recruit 24 participants who have suffered an mTBI within the last year and are between the ages of 18–55 years old. Participants are randomly assigned to one of two groups: an intervention group receiving 90 min of virtually-delivered, symptom-guided aerobic exercise weekly for 12 weeks, or a control group receiving 90 min of virtually-delivered balance exercises weekly for 12 weeks. Comprehensive assessments, including cognitive testing and multimodal neuroimaging, were conducted pre and post intervention. We implement physical activity monitoring during weeks 1, 6, and 12 using accelerometry to measure behavior changes. This study will establish the feasibility of virtual exercise delivery in mTBI populations and preliminary evidence regarding cognitive and brain health benefits of aerobic exercise in mTBI. Results will inform future large-scale trials and contribute to an accessible, evidence-based intervention for cognitive recovery after mTBI.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101608"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146167071","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Type I error control and interim monitoring for co-primary hypotheses involving a subgroup in the Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) trial","authors":"Jiayi Hu ,&nbsp;Abdel G. Babiker ,&nbsp;Cavan S. Reilly ,&nbsp;Jason V. Baker ,&nbsp;Lianne K. Siegel ,&nbsp;STRIVE OTAC Study Group","doi":"10.1016/j.conctc.2025.101592","DOIUrl":"10.1016/j.conctc.2025.101592","url":null,"abstract":"<div><div>The recent growth of immunoglobulin-based therapies has motivated clinical trials testing primary endpoints both in the overall cohort and in subgroups of patients, such as in patients without specific antibodies at baseline. Multiple testing methods in clinical trials often ignore the natural correlation between test statistics in such contexts, resulting in overly conservative type I error control. The Outpatient Treatment with Anti-Coronavirus Immunoglobulin (OTAC) trial, is an ongoing Phase III trial evaluating the effect of a single infusion of anti-COVID-19 hyperimmune intravenous immunoglobulin (hIVIG), in outpatient adults with recently diagnosed SARS-CoV-2 infection, in both the overall cohort and in the subgroup of participants who had not received monoclonal antibodies or antiviral treatments. We present the method used to control the type I error at a predetermined rate while taking the estimated correlation into account, thus increasing efficiency. We evaluated the operating characteristics of this method in both fixed and group-sequential scenarios through extensive simulation studies. Our findings indicate that this approach controls the type I error at the desired rate, improves power, and reduces the expected sample size compared to a Bonferroni correction. <strong>Trial Registration</strong>: This study was registered on clinicaltrials.gov under NCT0491026 on 1 June 2021.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"49 ","pages":"Article 101592"},"PeriodicalIF":1.4,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145926662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}