Contemporary Clinical Trials Communications最新文献

{"title":"Evaluation of a trauma center-based, technology enhanced stepped care intervention to promote the mental health recovery of adolescent traumatic injury survivors","authors":"Tatiana M. Davidson ,&nbsp;Theresa Skojec ,&nbsp;Priscilla Li ,&nbsp;Leigh E. Ridings ,&nbsp;Hannah Espeleta ,&nbsp;Sarah German ,&nbsp;Martina Mueller ,&nbsp;Robert Gates ,&nbsp;David Mooney ,&nbsp;Robert Russell ,&nbsp;Terri deRoon-Cassini ,&nbsp;Kenneth Ruggiero","doi":"10.1016/j.conctc.2026.101622","DOIUrl":"10.1016/j.conctc.2026.101622","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric traumatic injury (PTI) is a leading cause of hospitalization and long-term morbidity among U.S. youth, with approximately 30% developing posttraumatic stress or depression. Despite clear mandates from the American College of Surgeons (ACS) for behavioral health screening and referral, few pediatric trauma centers have the infrastructure to deliver coordinated mental health care. The Trauma Resilience and Recovery Program (TRRP) is a stepped-care, technology-enhanced model designed to promote psychological recovery following injury. This study evaluates the effectiveness of TRRP and identifies factors influencing its integration within pediatric trauma settings.</div></div><div><h3>Chods</h3><div>This multi-site, Type I hybrid effectiveness–implementation trial will recruit 300 adolescents (ages 12–17) hospitalized for traumatic injury and their caregivers across three pediatric trauma centers. Participants are randomized to TRRP or Enhanced Usual Care (EUC). TRRP includes bedside psychoeducation, risk screening, a brief coping skills intervention, automated text-based symptom monitoring, 30-day follow-up screening, and referral to evidence-based mental health care as needed. Primary outcomes (PTSD, depression, quality of life) are assessed at baseline, 3, 6, and 12 months. Qualitative interviews with families and trauma personnel, guided by the Consolidated Framework for Implementation Research (CFIR), will explore barriers and facilitators to implementation. Quantitative data will be analyzed using mixed-effects models; qualitative data will undergo thematic analysis.</div></div><div><h3>Conclusions</h3><div>This study will provide critical evidence on the clinical effectiveness and real-world integration of TRRP for adolescent trauma survivors. Findings will inform a scalable roadmap for embedding evidence-based behavioral health care into pediatric trauma systems to improve recovery and long-term well-being.</div><div>Clinicaltrials.gov idNCT05086757.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101622"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147356915","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":"Effectiveness of transoral robotic surgery of the base of the tongue vs. conservative treatment for obstructive sleep apnea, a RCT, the RAPID study protocol","authors":"A.G.L. Toppenberg ,&nbsp;J. van der Maten ,&nbsp;M. Bos ,&nbsp;W.J. Schuiling ,&nbsp;W.L. Lodder ,&nbsp;L.Q. Schwandt","doi":"10.1016/j.conctc.2026.101619","DOIUrl":"10.1016/j.conctc.2026.101619","url":null,"abstract":"<div><h3>Background</h3><div>CPAP is the gold standard treatment for obstructive sleep apnea (OSA) but suffers from poor long-term compliance. Alternatives like mandibular advancement devices (MADs) and surgery, such as transoral robotic surgery (TORS), are available, but their comparative efficacy is unclear.</div></div><div><h3>Study objective</h3><div>This study aims to evaluate whether base of the tongue (BOT) reduction using TORS is equal or superior to CPAP and MADs in improving quality of sleep and life in patients with moderate to severe OSA eligible for surgery.</div></div><div><h3>Study design</h3><div>A prospective randomized controlled trial.</div></div><div><h3>Population</h3><div>Patients eligible for TORS and CPAP or MAD aged &gt;18 years with moderate to severe OSA (Apnea Hypopnea Index &gt;15) untreated before.</div></div><div><h3>Interventions</h3><div>In total 50 patients, 25 in each treatment arm will be randomized to either TORS or non-surgical therapy (CPAP or MAD depending on preference of patient or physician).</div></div><div><h3>Outcome measures</h3><div>Primary outcomes will include improvement in sleep apnea severity measured through the apnea hypopnea index (AHI) and oxygen desaturation index (ODI)4%. Secondary outcomes will assess long-term quality of life compared to non-surgical therapy and adherence to devices.</div></div><div><h3>Results</h3><div>The data will be analysed on an Intention-To-Treat principle (ITT). Ethical approval was obtained from RTPO in September of 2023. Trial registration number: NL84446.099.23 METCnumber UMCG25.327. Outcomes will be published in peer reviewed journals and presented at (inter)national conferences.</div></div><div><h3>Discussion</h3><div>Findings of this study will address the evidence gap in the comparative effectiveness of TORS versus non-surgical therapies for OSA and may inform future clinical decision making and guideline development.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101619"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378888","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":"Rural targeted messaging, multiplex salivary measurement, and rural equity in SARS-CoV-2 antibody testing: Protocol overview of a SeroNet investigation","authors":"Leah Maschino ,&nbsp;Kelly A. Hirko ,&nbsp;Christopher D. Heaney ,&nbsp;Douglas A. Granger ,&nbsp;Steve W. Granger ,&nbsp;Anurag Dawadi ,&nbsp;Lindsey Rose ,&nbsp;Monicia Summers ,&nbsp;Nora Pisanic ,&nbsp;Olivia Aspiras ,&nbsp;Stefan M.M. Goetz ,&nbsp;Todd Lucas","doi":"10.1016/j.conctc.2026.101627","DOIUrl":"10.1016/j.conctc.2026.101627","url":null,"abstract":"<div><h3>Background</h3><div>Rural communities were disproportionately impacted by the COVID-19 pandemic. Current and future pandemic preparedness in rural areas could be aided by serological (antibody) testing. However, benefits to be gained from serosurveillance are challenged both by the accessibility of serological testing resources in hard-to-reach rural areas, and by likely hesitancy towards their use in many rural communities. Trials are needed to evaluate outreach and health communication strategies that can increase rural receptivity towards serosurveillance.</div></div><div><h3>Methods</h3><div>We conducted a two-arm randomized controlled trial that recruited N = 194 participants from rural northern Michigan. In a single online session lasting approximately 45 min, participants were randomly assigned to view either a general SARS-CoV-2 antibody testing didactic video, or a rural targeted didactic video co-created with a rural community advisory board and containing unique rural messaging. Primary self-report outcomes included receptivity to antibody testing, as well as activation of medical mistrust and concern for rural-discrimination in future SARS-CoV-2 antibody testing. We also developed and provided an opportunity to participate in a home-based salivary antibody screening program. In addition to assessing the feasibility and fidelity of this program, we assessed interest and full participation in the serosurveillance program as behavioral outcomes.</div></div><div><h3>Discussion</h3><div>Findings from this study can guide the use of home-based screening programs and targeted health communication strategies to promote greater uptake of health resources in rural communities. In doing so, study results can also guide public health strategies to reduce pandemic-related and other rural health disparities.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101627"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147386262","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 HEART-GP strategy for ruling out acute coronary syndrome in out-of-hours primary care: a diagnostic accuracy trial protocol","authors":"Indra M.B. Melessen ,&nbsp;Jelle C.L. Himmelreich ,&nbsp;Amy Manten ,&nbsp;Edanur Sert ,&nbsp;Simone van den Bulk ,&nbsp;Tobias N. Bonten ,&nbsp;Martijn H. Rutten ,&nbsp;Eric P. Moll van Charante ,&nbsp;Ralf E. Harskamp","doi":"10.1016/j.conctc.2026.101624","DOIUrl":"10.1016/j.conctc.2026.101624","url":null,"abstract":"<div><h3>Background</h3><div>Acute coronary syndrome (ACS) is a life-threatening condition that requires rapid identification to prevent morbidity and mortality. Differentiating ACS from benign conditions remains difficult in out-of-hours primary care (OOH-PC) settings due to non-specific and overlapping symptom profiles, and limited diagnostic resources. Current guidelines promote a low threshold for emergency department (ED) referral. Despite this cautious approach, ACS cases are still missed. The arrival of high-sensitivity troponin (hs-troponin) point-of-care testing (POCT) may enable safer, faster, and more efficient diagnosis.</div></div><div><h3>Methods and analysis</h3><div>This multicenter prospective diagnostic accuracy trial evaluates the <em>HEART-GP strategy</em>, combining a single fingerstick hs-troponin test with clinical assessment and optional ECG. Adults (≥18 years) presenting with acute chest pain or discomfort to one of four participating Dutch OOH-PC centers are eligible. The primary outcome is the occurrence of major adverse cardiovascular events a composite of death, ACS, or urgent revascularization within six weeks. Diagnostic safety (sensitivity, negative predictive value) and efficiency (ED referral reduction) will be compared against standard care. Secondary analyses will assess the value of sex-specific cut-offs and integration with existing risk scores.</div></div><div><h3>Anticipated results</h3><div>We anticipate that the <em>HEART-GP strategy</em> will demonstrate improved diagnostic safety along with efficiency gains in OOH-PC. Our straightforward rapid rule-out strategy holds promise to be widely implemented in primary care settings to advance the evaluation of acute chest pain.</div></div><div><h3>Ethics</h3><div>The study was approved by the Medical Research Ethics Committee of the Amsterdam UMC (NL82428.000.22, 02-03-2023) and registered in the ISRCTN-registry (ISRCTN11954040 <span><span>https://doi.org/10.1186/ISRCTN11954040</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101624"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147356931","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":"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}