Contemporary Clinical Trials Communications最新文献_第2页

Evaluation of a trauma center-based, technology enhanced stepped care intervention to promote the mental health recovery of adolescent traumatic injury survivors 评估创伤中心为基础，技术加强阶梯式护理干预，以促进青少年创伤幸存者的心理健康恢复。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-04-01 Epub Date: 2026-02-24 DOI: 10.1016/j.conctc.2026.101622

Tatiana M. Davidson , Theresa Skojec , Priscilla Li , Leigh E. Ridings , Hannah Espeleta , Sarah German , Martina Mueller , Robert Gates , David Mooney , Robert Russell , Terri deRoon-Cassini , Kenneth Ruggiero

Background

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.

Chods

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.

Conclusions

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.

Clinicaltrials.gov idNCT05086757.

背景：儿童创伤性损伤（PTI）是美国青少年住院和长期发病的主要原因，其中约30%的青少年发展为创伤后应激或抑郁症。尽管美国外科医师学会（American College of Surgeons， ACS）明确要求进行行为健康筛查和转诊，但很少有儿科创伤中心具备提供协调一致的精神卫生保健的基础设施。创伤恢复力和恢复计划（TRRP）是一个阶梯式护理，技术增强的模型，旨在促进受伤后的心理恢复。本研究评估TRRP的有效性，并确定影响其在儿科创伤设置整合的因素。方法：这项多地点、I型混合有效性实施试验将招募300名因创伤性损伤住院的青少年（12-17岁）及其护理人员，他们来自三个儿科创伤中心。参与者被随机分配到TRRP或增强常规护理（EUC）组。TRRP包括床边心理教育，风险筛查，简短的应对技能干预，基于文本的自动症状监测，30天的随访筛查，以及根据需要转介到循证精神卫生保健。主要结局（PTSD、抑郁、生活质量）在基线、3、6和12个月进行评估。在实施研究综合框架（CFIR）的指导下，对家庭和创伤人员进行定性访谈，探讨实施的障碍和促进因素。定量数据将使用混合效应模型进行分析；将对定性数据进行专题分析。结论：本研究将为青少年创伤幸存者TRRP的临床有效性和现实世界整合提供重要证据。研究结果将为将基于证据的行为卫生保健纳入儿科创伤系统提供可扩展的路线图，以改善康复和长期健康。

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引用次数: 0

Effectiveness of transoral robotic surgery of the base of the tongue vs. conservative treatment for obstructive sleep apnea, a RCT, the RAPID study protocol 经口舌底机器人手术与保守治疗阻塞性睡眠呼吸暂停的有效性，一项RCT， RAPID研究方案。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-04-01 Epub Date: 2026-02-21 DOI: 10.1016/j.conctc.2026.101619

A.G.L. Toppenberg , J. van der Maten , M. Bos , W.J. Schuiling , W.L. Lodder , L.Q. Schwandt

Background

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.

Study objective

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.

Study design

A prospective randomized controlled trial.

Population

Patients eligible for TORS and CPAP or MAD aged >18 years with moderate to severe OSA (Apnea Hypopnea Index >15) untreated before.

Interventions

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).

Outcome measures

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.

Results

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.

Discussion

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.

背景：CPAP是阻塞性睡眠呼吸暂停（OSA）的金标准治疗方法，但长期依从性较差。替代方案，如下颌推进装置（MADs）和手术，如经口机器人手术（TORS），是可用的，但其比较效果尚不清楚。研究目的：本研究旨在评价托尔托尔舌底复位在改善适合手术的中重度OSA患者的睡眠质量和生活质量方面是否等同于或优于CPAP和MADs。研究设计：前瞻性随机对照试验。人群：符合TORS和CPAP或MAD条件的患者，年龄b>8岁，既往未接受治疗的中度至重度OSA（呼吸暂停低通气指数b>5）。干预措施：总共50名患者，每个治疗组25名患者将随机接受tor或非手术治疗（CPAP或MAD取决于患者或医生的偏好）。结局指标：主要结局将包括通过呼吸暂停低通气指数（AHI）和氧去饱和指数（ODI）4%测量的睡眠呼吸暂停严重程度的改善。次要结果将评估与非手术治疗和器械依从性相比的长期生活质量。结果：数据将根据意向治疗原则（ITT）进行分析。于2023年9月获得RTPO的伦理批准。试验注册号：NL84446.099.23 METCnumber UMCG25.327。研究结果将发表在同行评议的期刊上，并在（国际）国家会议上发表。讨论：本研究的发现将解决TORS与非手术治疗OSA比较有效性的证据差距，并可能为未来的临床决策和指南制定提供信息。

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引用次数: 0

Rural targeted messaging, multiplex salivary measurement, and rural equity in SARS-CoV-2 antibody testing: Protocol overview of a SeroNet investigation 农村定向信息传递、多重唾液测量和SARS-CoV-2抗体检测中的农村公平性：一项SeroNet调查的方案概述

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-04-01 Epub Date: 2026-03-09 DOI: 10.1016/j.conctc.2026.101627

Leah Maschino , Kelly A. Hirko , Christopher D. Heaney , Douglas A. Granger , Steve W. Granger , Anurag Dawadi , Lindsey Rose , Monicia Summers , Nora Pisanic , Olivia Aspiras , Stefan M.M. Goetz , Todd Lucas

Background

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.

Methods

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.

Discussion

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.

农村社区受到COVID-19大流行的影响尤为严重。血清学（抗体）检测有助于农村地区当前和未来的大流行防范工作。然而，由于难以到达的农村地区能否获得血清学检测资源，以及许多农村社区可能对使用血清学检测资源犹豫不决，因此，从血清监测中获得的益处受到了挑战。需要进行试验，以评估能够提高农村对服务监测接受程度的外联和卫生传播战略。方法我们进行了一项两组随机对照试验，从密歇根州北部农村招募了N = 194名参与者。在一次持续约45分钟的在线会议中，参与者被随机分配观看一般的SARS-CoV-2抗体检测教学视频，或与农村社区咨询委员会共同制作的针对农村的教学视频，其中包含独特的农村信息。自我报告的主要结果包括对抗体检测的接受程度，以及在未来的SARS-CoV-2抗体检测中引发的医疗不信任和对农村歧视的担忧。我们还开发并提供了一个参与家庭唾液抗体筛查项目的机会。除了评估该计划的可行性和保真度外，我们还评估了对服务监测计划的兴趣和充分参与作为行为结果。讨论本研究的发现可以指导家庭筛查项目和有针对性的健康传播策略的使用，以促进农村社区更多地利用卫生资源。这样，研究结果还可以指导公共卫生战略，以减少与大流行病有关的差距和其他农村保健差距。

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引用次数: 0

The HEART-GP strategy for ruling out acute coronary syndrome in out-of-hours primary care: a diagnostic accuracy trial protocol 在非工作时间初级保健中排除急性冠状动脉综合征的HEART-GP策略：诊断准确性试验方案。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-04-01 Epub Date: 2026-02-21 DOI: 10.1016/j.conctc.2026.101624

Indra M.B. Melessen , Jelle C.L. Himmelreich , Amy Manten , Edanur Sert , Simone van den Bulk , Tobias N. Bonten , Martijn H. Rutten , Eric P. Moll van Charante , Ralf E. Harskamp

Background

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.

Methods and analysis

This multicenter prospective diagnostic accuracy trial evaluates the HEART-GP strategy, 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.

Anticipated results

We anticipate that the HEART-GP strategy 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.

Ethics

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 https://doi.org/10.1186/ISRCTN11954040).

背景：急性冠脉综合征（ACS）是一种危及生命的疾病，需要快速识别以预防发病率和死亡率。由于非特异性和重叠的症状特征，以及有限的诊断资源，在非工作时间的初级保健（oh - pc）环境中，区分ACS和良性疾病仍然很困难。目前的指南提倡低门槛的急诊科（ED）转诊。尽管采取这种谨慎的方法，ACS病例仍然被遗漏。高灵敏度肌钙蛋白（hs-troponin）即时检测（POCT）的出现可能使诊断更安全、更快、更有效。方法和分析：这项多中心前瞻性诊断准确性试验评估了HEART-GP策略，将单指肌钙蛋白检测与临床评估和可选心电图相结合。有急性胸痛或不适症状的成人（≥18岁）到四个荷兰oh - pc中心之一就诊符合条件。主要结局是6周内主要心血管不良事件的发生，包括死亡、ACS或紧急血运重建。诊断安全性（敏感性，阴性预测值）和效率（ED转诊减少）将与标准护理进行比较。二次分析将评估性别特异性截断值的价值以及与现有风险评分的整合。预期结果：我们预计HEART-GP策略将显示出oh - pc诊断安全性的提高以及效率的提高。我们直截了当的快速排除策略有望在初级保健机构广泛实施，以推进急性胸痛的评估。伦理：该研究已获得阿姆斯特丹UMC医学研究伦理委员会批准（NL82428.000.22, 02-03-2023），并在isrctn注册中心注册（ISRCTN11954040 https://doi.org/10.1186/ISRCTN11954040）。

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引用次数: 0

MiBUP: A pilot randomized controlled trial of low-dose initiation of buprenorphine for opioid use disorder: Design and rationale MiBUP：一项小剂量丁丙诺啡治疗阿片类药物使用障碍的随机对照试验：设计和基本原理

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-02-01 Epub Date: 2026-01-05 DOI: 10.1016/j.conctc.2026.101594

Benjamin T. Hayes , Annika Sabado , Haruka Minami , Chenshu Zhang , Matthew Holm , Laila Khalid , Tiffany Y. Lu , Kristine Torres-Lockhart , Aaron D. Fox

Background

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.

Methods

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.

Discussion

As a pilot clinical trial this study will inform design of a fully powered RCT to test buprenorphine LDI in the ambulatory setting.

Trial registration ClinicalTrials.gov, NCT05450718: date of registration: June 22, 2022; https://clinicaltrials.gov/study/NCT05450718?term=NCT05450718&rank=1.

丁丙诺啡是一种有效的治疗阿片类药物使用障碍（OUD）的药物，然而在起始期停药是一个障碍。低剂量起始（LDI）包括开始非常小剂量的丁丙诺啡与阿片类药物重叠，以避免戒断。本初步研究旨在评估一项随机对照试验（RCT）的可行性，比较丁丙诺啡LDI和标准起始在门诊OUD患者中的应用。方法：这是一项实用的平行组开放标签试点随机对照试验，比较LDI和标准起始在门诊环境下的差异。LDI组：开始时每天服用0.5-0.125毫克舌下丁丙诺啡-纳洛酮片，8天内逐渐达到治疗剂量。标准组：受试者在开始服用4-1毫克前达到中度戒断。两组治疗目标：16-4毫克至32-8毫克。共有70名患有严重程度OUD的成年人（18岁或以上）将被招募。主要排除包括目前正在接受OUD药物治疗、严重酒精或苯二氮卓类药物使用障碍、严重精神疾病和怀孕。主要结局：招募初级保健OUD患者参加LDI临床试验的可行性，以参加研究的评估参与者的百分比来衡量。关键次要结局：LDI方案的可行性，即方案的依从性（即从少于1mg的丁丙诺啡开始，每天增加剂量）；在为期两周的研究访问中，丁丙诺啡尿检阳性证实了治疗的初步有效性；用药房配药丁丙诺啡测定6周治疗效果；以及安全结果。作为一项试点临床试验，该研究将为设计一项全功率随机对照试验提供信息，以在门诊环境中测试丁丙诺啡LDI。临床试验注册：ClinicalTrials.gov, NCT05450718；注册日期：2022年6月22日；https://clinicaltrials.gov/study/NCT05450718?term=NCT05450718&等级= 1。

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引用次数: 0

Strategic risk assessment in oncology: Utilizing single-agent activity to boost combination therapy approvals 肿瘤学的战略风险评估：利用单药活性促进联合治疗的批准

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-02-01 Epub Date: 2025-12-30 DOI: 10.1016/j.conctc.2025.101590

Adetayo Kasim , Marina Anastasiou , Evangelia Loizou , Andreas Dimakakos , Maria Georganaki , Ioannis Mourelatos , Panos Karelis , Marianna Esposito , Helen Zhou , Tai-Tsang Chen , Dimitrios Skaltsas , Paul Stockman

Background

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.

Methods

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).

Results

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.

Conclusions

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.

本研究探讨早期临床阶段的单药活性是否与肿瘤联合治疗获批的可能性相关。使用Intelligencia AI数据库，我们调查了单一治疗疗效对联合治疗成功率的影响。方法分析各种实体瘤类型的联合治疗，评估批准率和单一治疗的有效性，截止日期为2024年9月12日，评估3896个项目。我们分析了历史临床试验数据，重点关注客观缓解率（ORR）作为单药活性（SAA）的指标。结果所有适应症和阶段联合用药方案的批准率为4.2%。包括批准的单一治疗药物的项目的批准率为6.1%，而那些没有批准的单一治疗药物的项目的批准率较低，为2.7%。然而，客观缓解率超过20%的失败单药联合方案的历史批准率为5.8%。此外，来自单一治疗失败管道的批准组合显示出不同的ORR阈值，在不同的癌症类型中观察到特定的趋势。结论：当与先前显示单药活性的单药治疗药物联合使用时，联合治疗获得批准的可能性更高。这一发现与其他关于历史批准率的研究以及肿瘤药物开发的共同共识是一致的。在这里，我们建议通过利用单一治疗药物活性，可以提高抗癌药物的优先级，重新用于联合治疗，否则这些药物将因单一药物失败而被搁置。

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引用次数: 0

Study of Chemosensory Enhancement through Neuromodulation Training (SCENT): Design and methodology of a randomized clinical trial for COVID-related persistent smell dysfunction 通过神经调节训练增强化学感觉的研究：一项针对covid - 19相关持续性嗅觉功能障碍的随机临床试验的设计和方法

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-02-01 Epub Date: 2025-12-05 DOI: 10.1016/j.conctc.2025.101582

Nicole Cash , Mary Clare Koebel , Bashar W. Badran , Aicko Y. Schumann , Lisa M. McTeague , Thomas W. Uhde , Rodney J. Schlosser , Bernadette M. Cortese

Background

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.

Methods

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.

Conclusion

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.

针对与新冠病毒相关的持续性嗅觉功能障碍，目前几乎没有循证治疗方法。虽然嗅觉/嗅觉训练（ST）已成为一种广泛规定的一线治疗方法，但需要严格的研究来确定其对长期COVID的疗效。还需要进一步研究和开发辅助方法来提高ST的疗效。方法：本文详细介绍了一项大型、家庭、随机、对照试验的研究设计和方法，旨在确定ST和/或三叉神经刺激（TNS）增强的ST是否能改善与covid - 19相关的嗅觉功能、情绪、睡眠和认知障碍。将招募患有与新冠病毒相关的持续性嗅觉功能障碍的成年人（N = 180），并将其随机分为自我管理ST、安慰剂嗅觉训练（PBO）或tns增强的ST，持续12周。我们的主要目标是i)确定与任何自然功能增益相比，ST对嗅觉特异性缺陷的疗效，ii)确定ST对嗅觉特异性缺陷的tns增强作用，以及iii)确定与ST相比，tns增强的ST在治疗长COVID的其他症状方面是否也更有效。结论新冠肺炎后持续性嗅觉功能障碍及相关功能障碍较为常见，治疗方案较少。我们提出的研究将为进一步开发ST和TNS作为长期COVID的循证治疗奠定基础。

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引用次数: 0

The clinical rollout of a novel intervention for Veterans with persistent post-concussive symptoms: Protocol for a pragmatic 2-site trial of On-TRACC 一项针对持续脑震荡后症状的退伍军人的新型干预措施的临床推广：On-TRACC的实用2点试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-02-01 Epub Date: 2025-12-05 DOI: 10.1016/j.conctc.2025.101584

Kathleen F. Pagulayan , Holly K. Rau , Rishika Das , Jennifer K. Bambara , Jeanne M. Hoffman , Rhonda M. Williams

Background and objectives

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.

Methods

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.

Projected outcomes

The primary aim is to examine whether On-TRACC participation improves engagement in treatment of secondary conditions recommended by the CTBIE provider.

背景和目的有轻度创伤性脑损伤（mTBI）病史的退伍军人经常报告持续的脑震荡后症状（PPCS）。临床护理指南推荐心理教育以及评估和治疗常见的共病精神、睡眠和疼痛状况，这些已知会导致和加剧PPCS。这项现场随机实用试验的目的是检验一种新的5周认知康复/自我管理干预的有效性，该干预旨在提高认知性PPCS退伍军人mTBI评估后合并症的治疗参与度。方法son - tracc（康复和认知护理工具）是一种5期的人工干预，将在两个退伍军人健康管理局（VHA）的多创伤站点按随机顺序临床推广，间隔大约一年。在临床推广后完成全面创伤性脑损伤评估（CTBIE）的退伍军人，如果CTBIE临床提供者认为临床合适，将提供On-TRACC。从电子健康记录（EHR）的回顾性审查中收集的数据将用于评估CTBIE后一年或On-TRACC完成后一年参与干预的人的治疗参与模式。接受On-TRACC干预的参与者（n = 75）将与完成CTBIE但未接受On-TRACC干预的参与者（n = 75）进行比较。为了评估临床效果并尽量减少抽样偏差，不会直接从参与者那里收集数据。预期结果主要目的是检查On-TRACC的参与是否提高了CTBIE提供者推荐的继发疾病治疗的参与度。

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引用次数: 0

Epilepsy journey 2.0 study design and methods: A randomized trial of an executive functioning intervention for adolescents with epilepsy 癫痫之旅2.0研究设计和方法：一项针对青少年癫痫患者的执行功能干预的随机试验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-02-01 Epub Date: 2026-01-21 DOI: 10.1016/j.conctc.2026.101605

Angela B. Combs , Janelle L. Wagner , Heather Huszti , Shari L. Wade , Matthew Schmidt , Stacy Buschhaus , Jake Scherra , Sara E. Wetter-Wren , David Ogundairo , Christopher Coffey , Dixie Ecklund , Emine Bayman , Sonal Bhatia , Tracy Glauser , Kristina K. Hardy , Avani C. Modi

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.

癫痫是一种常见的神经系统疾病，给青少年带来了独特的挑战。执行功能（EF）缺陷会导致学业、社交和生活质量不理想的结果，但目前缺乏针对儿童癫痫患者EF的干预措施。一种很有前景的干预措施是癫痫之旅（EJ），这是一种全面的电子卫生、多组件解决问题的干预措施，包括由治疗师促进的自学学习模块和远程医疗会议。本文描述了改善EF行为的多站点3期随机对照试验（RCT; ej2.0）的方法学、咨询委员会反馈、对原始方案/干预措施的修改以及当前进展。在RCT之前，由6名青少年、2名看护人、2名教师和2名医疗保健提供者组成的咨询委员会提供了关于招募/保留、测量选择和干预成分的反馈。在随机对照试验中，符合ej2.0资格标准的青少年（13-17岁）被随机分为四组：仅EJ模块组、仅EJ远程医疗组、EJ模块与远程医疗组或常规癫痫护理组。三个治疗组的参与者分别学习与积极思考、解决问题、工作记忆、组织、抑制、启动、任务/自我监控、情绪调节和睡眠/压力相关的问题解决目标。目标是在三个地点随机抽取232名参与者。通过咨询委员会的反馈，ej2.0研究得到了加强，随后的方案变更对迄今为止试验的成功启动和执行至关重要。尽管存在短暂的资金缺口，但研究小组在早期招募方面取得了重大进展。

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引用次数: 0

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 探讨抗毒素解热汤治疗风热阻外热侵肺急性呼吸道病毒感染的疗效和安全性——随机对照试验的研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2026-02-01 Epub Date: 2025-12-12 DOI: 10.1016/j.conctc.2025.101585

Wen-Han Li , Dong-Chen Xu , Xi-Yue Lu , Jin-Ye Ma , Fang-Fang Chen , Hao Wang , Hao Li , Zhan-Fei Tan

Background

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.

Methods

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.

Discussion

This study aims to provide evidence on the efficacy and safety of AAD in the treatment of acute respiratory viral infections.

急性呼吸道病毒感染是影响呼吸系统的最常见疾病。目前，还缺乏针对各种病毒的特异性抗病毒药物。传统中草药具有多种成分和多种治疗靶点，已成为一种有前途的治疗选择。“抗毒素解热汤”（AAD）是一种传统的中药方剂，在临床实践中已被报道能有效地退烧和缓解相关症状。然而，评价AAD治疗急性呼吸道病毒感染的临床研究不足。因此，本研究旨在评估AAD治疗急性呼吸道病毒感染的疗效。方法单中心、随机、双盲、对照试验。总共120名符合条件的患者将按1:1的比例随机分配接受AAD颗粒或安慰剂颗粒。试验为期5天，第3、6、12天随访。主要结果是受试者在第6天完全退烧的比例。次要结局包括完全退烧时间、首次退烧时间、紧急解热药物的使用率和平均剂量、个体症状评分（发热、疲劳、咳嗽、肌肉疼痛、味觉和嗅觉障碍、腹泻、鼻塞、流鼻涕、头痛和疲劳）的绝对值和变化值、中医证候评分和病毒清除时间。试验期间发生的任何不良事件均由研究人员记录。于2024年8月至2024年10月进行了小样本前瞻性试点研究，以测试试验程序的可行性；本议定书所述的主要研究尚未开始。本研究旨在为AAD治疗急性呼吸道病毒感染的有效性和安全性提供证据。

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引用次数: 0