Contemporary Clinical Trials Communications最新文献_第3页

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 : 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

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 : 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 : 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

Effectiveness of hippotherapy on balance performance, neurophysiological parameters and clinical symptoms of multiple sclerosis: Study protocol of a randomized controlled multicenter study (MS-HIPPO II - Movement in Balance) 海马疗法对平衡能力、神经生理参数和多发性硬化症临床症状的影响：一项随机对照多中心研究方案（MS-HIPPO II -平衡运动）

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-05 DOI: 10.1016/j.conctc.2025.101583

Isabel Stolz , Leonard Braunsmann , Franca Rosiny , Dieter Poehlau , Thomas Abel , Volker Anneken , Marion Drache , Kristel Knaepen

Background

Exercise and physical therapy have been shown to be effective in the non-pharmacological symptomatic treatment of multiple sclerosis (MS). Hippotherapy as an additive physical therapy intervention is applied in this study to promote balance and postural control, since the number of sufficiently high-quality randomized controlled trials indicating its effectiveness is limited.

Objective

This study aims to provide more in-depth insights into the effectiveness of hippotherapy in MS in terms of balance and other patient-relevant outcomes, building on the results of a preliminary study (MS-HIPPO II, evidence level 1b).

Methods

Based on a prospective, randomized, investigator-blinded, controlled multicenter study design, the primary endpoint of differences in balance will be investigated. Patients will be randomized to an intervention group (12 weeks of hippotherapy) or a control group (12 weeks of treatment as usual). Balance will be measured using the Berg Balance Scale (BBS) plus a standardized balance task on a force plate (AccuGait-Optimized, Advanced Mechanical Technology, Inc., Massachusetts, US) and a balance perturbation task on an oscillating sensorimotor therapy device (Bioswing Posturomed®, Haider, Pullenreuth, Germany). During balance tasks, electrocortical activity will be investigated using electroencephalography (EEG) (LiveAmp 32, Brain Products GmbH, Gilching, Germany). Secondary endpoints include fatigue (FSS), quality of life (MSQoL-54), pain (VAS), spasticity (NRS) and participation (WHODAS 2.0). Therapy progress will be documented via an ICF-based hippotherapy assessment-tool (EQUITEDO®, Frechen, Germany).

Results and conclusions

The results should contribute to improve the understanding of non-pharmaceutical treatment options in the field of exercise and movement therapy in MS.

Trial registration

The trial was registered at March 05, 2024 in the German Clinical Trial Register under DRKS00033449.

运动和物理治疗已被证明在多发性硬化症（MS）的非药物对症治疗中是有效的。由于高质量的随机对照试验数量有限，因此本研究将海马疗法作为一种辅助物理治疗干预来促进平衡和姿势控制。本研究旨在基于一项初步研究（MS- hippo II，证据水平1b）的结果，更深入地了解海马疗法在MS中平衡和其他患者相关结局方面的有效性。方法采用前瞻性、随机、研究者盲法、对照多中心研究设计，研究平衡差异的主要终点。患者将被随机分为干预组（接受12周的海马疗法）或对照组（照常接受12周的治疗）。平衡将使用伯格平衡量表（BBS）进行测量，外加一个在测力板上的标准化平衡任务（AccuGait-Optimized, Advanced Mechanical Technology, Inc.，马萨诸塞州，美国）和一个在振荡感觉运动治疗装置上的平衡扰动任务（Bioswing postromed®，Haider, Pullenreuth，德国）。在平衡任务期间，将使用脑电图（EEG）研究皮层电活动（LiveAmp 32, Brain Products GmbH, Gilching, Germany）。次要终点包括疲劳（FSS）、生活质量（MSQoL-54）、疼痛（VAS）、痉挛（NRS）和参与（WHODAS 2.0）。治疗进展将通过基于icf的海马治疗评估工具（EQUITEDO®，Frechen, Germany）进行记录。结果和结论该结果将有助于提高对ms运动和运动治疗领域非药物治疗选择的理解。试验注册该试验于2024年3月5日在德国临床试验注册中心注册，编号为DRKS00033449。

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引用次数: 0

Study design and protocol for a randomized clinical trial investigating a brief fear of uncertainty-focused intervention as an adjunct to project safe guard for military personnel 一项随机临床试验的研究设计和方案，调查作为军事人员安全防护项目辅助的以不确定性为重点的干预的短暂恐惧

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101577

Samantha E. Daruwala , Kayley Stratton , Grace Y. Cho , Michael D. Anestis , Craig J. Bryan , Nicholas P. Allan

Background

In the United States (US), the proportion of firearm suicide deaths are higher among military personnel compared to the general population. Secure firearm storage practices (e.g., gun safe, unloaded) can reduce the risk of firearm suicide. A randomized controlled trial, called Project Safe Guard (PSG) found that providing lethal means counseling (LMC) to firearm-owning service members increased secure firearm storage practices; however, some still stored at least one firearm unsecurely. Intolerance of uncertainty (IU) may be a barrier to secure firearm storage that decreases the effectiveness of LMC. This study will examine the impact of a brief intervention that targets IU (i.e., Cognitive behavioral therapy for Uncertainty Enhanced; CUE) on improving the effectiveness of PSG-LMC on secure firearm storage practices among firearm-owning service members. In this protocol paper, we describe the rationale and methodology for this study.

Methods

This study uses a counterbalanced design with two conditions to test the acceptability, feasibility, and potential efficacy of both interventions with 100 current or recently discharged service members who report elevated IU and storing at least one firearm unsecurely. Participants are randomized to either receive CUE or PSG-LMC first, and then receive the second intervention approximately two weeks later. Participants will complete a baseline assessment, ecological momentary assessment (EMA) via their mobile devices, and follow-ups at 1-, 3-, 6-, 9-, and 12-months post-baseline. All interventions will be delivered remotely.

Conclusions

This study aims to inform how to improve firearm safety in military personnel with elevated IU.

背景在美国，军事人员因枪支自杀死亡的比例高于普通民众。安全的枪支储存做法（例如，枪支安全，没有子弹）可以减少枪支自杀的风险。一项名为“安全保卫项目”（PSG）的随机对照试验发现，向拥有枪支的服役人员提供致命手段咨询（LMC）可以增加枪支储存的安全性；然而，一些人仍将至少一支枪存放在不安全的地方。不确定性不耐受（IU）可能是安全枪支储存的障碍，降低了LMC的有效性。本研究将检验针对IU的简短干预（即，不确定性增强认知行为疗法；CUE）对提高PSG-LMC在拥有枪支的服役人员中安全枪支储存实践中的有效性的影响。在这份协议文件中，我们描述了这项研究的基本原理和方法。方法本研究采用两种条件下的平衡设计，对100名报告IU升高和至少有一支枪支存放不安全的现役或最近退伍的军人进行了两种干预措施的可接受性、可行性和潜在疗效的测试。参与者首先随机接受CUE或PSG-LMC，然后在大约两周后接受第二次干预。参与者将通过他们的移动设备完成基线评估、生态瞬时评估（EMA），并在基线后1、3、6、9和12个月进行随访。所有干预措施都将远程提供。结论本研究旨在探讨如何提高高IU军人的枪支安全。

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引用次数: 0

Yogurt reintroduction and the circulating microbiome in healthy volunteers: protocol for a prospective, longitudinal, species-controlled crossover clinical trial (MAMI) 健康志愿者重新引入酸奶和循环微生物组：一项前瞻性、纵向、物种对照的交叉临床试验（MAMI）方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101579

Junhong Su , Bettina E. Hansen , Zifang Wang , Abylaikhan Sharmenov , Xueshan Xia , Michelle Broekhuizen , Zhongren Ma , Maikel P. Peppelenbosch

Background

Although the gut microbiome plays a crucial role for maintaining overall host homeostasis and metabolism, it is significantly influenced by dietary changes, leading to substantial temporal variations in microbial composition within and between individuals. Despite this, incidental fecal sampling remains the standard method for microbiome assessment. Recently, the blood microbiome, defined by microbial DNA (cmDNA) circulating in the bloodstream, has emerged as a potentially more stable and integrated alternative. Preliminary data suggest that blood microbiome analysis may offer more consistent insights than fecal-based approaches, although the methodological validity of the approach has been questioned.

Method/design

This study aims to establish or rule-out cmDNA as a representative of the gut microbiome. In a prospective, single-arm crossover trial, effects of dairy product withdrawal and reintroduction of a yoghurt with a known consortium of bacteria will be assessed in healthy volunteers aged 18–65. Participants will first abstain from all dairy products, a phase expected to reduce yogurt-associated cmDNA in the bloodstream. Yogurt will then be reintroduced, during which reappearance of cmDNA of specific bacteria (especially LGG, LA-5 and BB-12) is anticipated. Shotgun metagenomic sequencing will be used to track cmDNA dynamics over time. This longitudinal sampling approach will provide experimental evidence supporting the existence and responsiveness of the circulating microbiome, while also revalidating the bioinformatic pipeline used for its analysis.

Conclusion

This pilot study will test whether blood-derived microbial DNA can serve as a valid surrogate for gut microbiome composition. If successful, this approach may provide a more stable and integrative alternative to fecal sampling and support future biomarker development and mechanistic research.

Clinical trial registration

NCT06944002.

虽然肠道微生物组在维持宿主整体稳态和代谢方面起着至关重要的作用，但它受到饮食变化的显著影响，导致个体内部和个体之间微生物组成的实质性时间变化。尽管如此，偶然的粪便取样仍然是微生物组评估的标准方法。最近，血液微生物组，由血液循环中的微生物DNA （cmDNA）定义，已经成为一种潜在的更稳定和综合的替代方案。初步数据表明，血液微生物组分析可能比基于粪便的方法提供更一致的见解，尽管该方法的方法学有效性受到质疑。方法/设计本研究旨在确定或排除cmDNA作为肠道微生物组的代表。在一项前瞻性单臂交叉试验中，将在18-65岁的健康志愿者中评估停用乳制品和重新引入含有已知细菌联合体的酸奶的影响。参与者首先将戒掉所有乳制品，这一阶段有望减少血液中与酸奶相关的cmDNA。然后重新引入酸奶，在此期间预计会出现特定细菌（特别是LGG， LA-5和BB-12）的cmDNA。霰弹枪宏基因组测序将用于跟踪cmDNA随时间的动态。这种纵向采样方法将提供实验证据，支持循环微生物组的存在和响应性，同时也重新验证用于其分析的生物信息学管道。结论本初步研究将检验血液来源的微生物DNA是否可以作为肠道微生物组组成的有效替代物。如果成功，这种方法可能为粪便取样提供更稳定、更综合的替代方法，并支持未来生物标志物的开发和机制研究。临床试验注册号nct06944002。

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引用次数: 0

A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults 光生物调节治疗成人颞下颌紊乱性疼痛的随机对照试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101571

Selenia Rubio , Patricia Cabrera , Rory Reever , Cesar Migliorati , Richard Ohrbach , Frank C. Gibson III , Zhigang Li , Angela Mickle , Rosalynn R.Z. Conic , Roger B. Fillingim , Margarete Ribeiro Dasilva

Evidence-based treatments for painful temporomandibular disorders (TMD) are lacking. The most common treatments for painful TMDs, intraoral appliances and pain medication, provide suboptimal pain control, often leading to treatment-limiting adverse effects. Photobiomodulation therapy (PBM) shows substantial potential for the management of pain in people with a TMD; however, its efficacy for TMD pain reduction has not been rigorously tested. We will conduct a double-blind, randomized, placebo-controlled clinical trial of multimodal PBM for TMD pain. This single-site trial will randomize 130 participants, aged 18 years and older, with chronic painful TMD. Individuals will complete a detailed medical history to confirm eligibility criteria, followed by a clinical exam to confirm TMD case status according to the Diagnostic Criteria for TMD (DC/TMD). Eligible participants will be randomized to either active or sham PBM treatment. Participants will complete eight treatment visits scheduled 2–5 days apart. This will be followed by a post-intervention visit that will include symptom questionnaires, TMD exam, pressure pain threshold (PPT) measures, and blood draw. A 6-month follow-up visit will include a TMD exam, questionnaires, and pressure pain threshold measures. Analyses will determine intervention effects on the primary outcome (pain intensity) and multiple secondary outcomes and will examine whether changes in inflammation and pain sensitivity are associated with the intervention response.

Clinicaltrials.gov identifier

NCT05916235

目前缺乏针对疼痛性颞下颌疾病（TMD）的循证治疗方法。对于疼痛的颞下颌关节痛，最常见的治疗方法，口腔内矫治器和止痛药，提供了次优的疼痛控制，往往导致治疗限制的不良反应。光生物调节疗法（PBM）显示出治疗TMD患者疼痛的巨大潜力；然而，其减轻TMD疼痛的功效尚未经过严格的测试。我们将进行一项双盲、随机、安慰剂对照的多模式PBM治疗TMD疼痛的临床试验。这项单点试验将随机抽取130名18岁及以上的慢性疼痛性TMD患者。个人将完成详细的病史以确认资格标准，然后根据TMD诊断标准（DC/TMD）进行临床检查以确认TMD病例状态。符合条件的参与者将随机接受积极或假PBM治疗。参与者将完成8次治疗访问，间隔2-5天。随后将进行干预后随访，包括症状问卷调查、TMD检查、压痛阈值（PPT）测量和抽血。6个月的随访将包括TMD检查、问卷调查和压力痛阈测量。分析将确定干预对主要结局（疼痛强度）和多个次要结局的影响，并将检查炎症和疼痛敏感性的变化是否与干预反应相关

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引用次数: 0

Frontier sites in clinical trials: Opportunities, challenges, and models 临床试验的前沿地点：机遇、挑战和模式

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101581

Andrea Bastek , Amanda Zenere , Heather Manley , Camille Finkle , Chad Jaeger , Janet Matthews , Kristie Moffett , Megan Solomon , Paula Underhill

Background

The clinical trials industry faces a growing capacity gap driven by an increasing number of studies combined with site and staff shortages. The Site Enablement League (SEL) Task Force on Frontier Sites was established to explore the potential of non-traditional research sites—termed "frontier sites"—to address these issues by expanding access to underserved populations and embedding clinical research in community settings.

Methods

The task force defined frontier sites and conducted a survey to gather perspectives on their benefits, challenges, and support needs. Twenty-nine valid survey responses were collected. Respondents self-identified as having direct experience with frontier sites (“experienced respondents”) or answered based on their perception of working with frontier sites (“perception respondents”). Free-text responses were coded into categories and analyzed qualitatively and quantitatively.

Results

Access to new participant populations was the most cited benefit, and experienced respondents noted additional gains in site engagement and education. Operational infrastructure deficiencies were the primary challenge identified by both experienced and perception respondents. Experienced respondents highlighted greater concerns about compliance and community resistance. The primary support need identified was enhanced operational support and quality oversight. Differences between experienced and perception respondent groups suggested the need for broader industry education.

Conclusion

Frontier sites offer significant promise for increasing research capacity and diversity, but require substantial operational, educational, and community engagement support. These survey findings provide a foundation for shared understanding across the industry. From that foundation the industry can work to develop a playbook to guide the successful integration of frontier sites into clinical trial operations.

临床试验行业面临着越来越大的能力缺口，原因是研究数量不断增加，加上场地和人员短缺。前沿站点启用联盟（SEL）工作组的成立是为了探索非传统研究站点（称为“前沿站点”）的潜力，通过扩大对服务不足人群的访问和在社区环境中嵌入临床研究来解决这些问题。方法工作组确定了前沿站点，并进行了一项调查，以收集对其利益、挑战和支持需求的看法。收集了29份有效的调查回复。受访者自我认定有直接的边境工作经验（“有经验的受访者”），或根据他们对边境工作的感知来回答（“感知受访者”）。对自由文本回复进行分类，并进行定性和定量分析。结果获得新的参与者群体是被引用最多的好处，有经验的受访者注意到在现场参与和教育方面的额外收益。运营基础设施不足是经验丰富的受访者和有经验的受访者都认为的主要挑战。经验丰富的受访者强调了对合规性和社区阻力的更大担忧。确定的主要支助需要是加强业务支助和质量监督。有经验的受访者和有经验的受访者之间的差异表明，需要进行更广泛的行业教育。前沿站点为提高研究能力和多样性提供了巨大的希望，但需要大量的运营、教育和社区参与支持。这些调查结果为整个行业的共识提供了基础。在此基础上，该行业可以制定一份指南，指导将前沿站点成功整合到临床试验操作中。

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引用次数: 0

Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3 更新的监管指南对当代无并发症尿路感染临床试验研究结果的影响以及对试验进行和药物开发的影响：EAGLE-2和EAGLE-3的比较分析

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101572

Florian Wagenlehner , Keith S. Kaye , David A. Talan , Amanda J. Sheets , Nicole E. Scangarella-Oman , Emily Jarvis , Jeremy Dennison , Salim Janmohamed , Matthew Helgeson , Caroline Perry

Aim

To understand the impact of current regulatory guidance for non-inferiority, randomized controlled trials (RCTs) in uncomplicated urinary tract infection (uUTI) on efficacy outcomes.

Methods

EAGLE-2 and EAGLE-3 were phase 3, non-inferiority RCTs of oral gepotidacin (1500 mg twice daily for 5 days) vs nitrofurantoin (100 mg BID for 5 days) in females with uUTI. The composite (clinical and microbiological) primary endpoint, therapeutic response (success or failure), was assessed at test-of-cure (day 10–13) in participants with nitrofurantoin-susceptible uropathogens (≥10⁵ colony forming units/mL). Success required symptom resolution plus microbiological eradication; missing data or additional antibacterial use were considered failure. EAGLE-2/-3 results were compared with historic nitrofurantoin RCTs and exploratory endpoints – symptom “resolution or near resolution” (one mild symptom remaining) and investigator-assessed clinical response (IACR) – were used as alternative measures of clinical success.

Results

Nitrofurantoin therapeutic success was substantially lower in EAGLE-2/-3 (47 %/44 %) than historic studies (61–94 %) using different endpoints. Clinical success rates based on “resolution or near resolution” of symptoms were: 78.3 %/77.2 % (EAGLE-2) and 75.7 %/75.3 % (EAGLE-3) for gepotidacin/nitrofurantoin, respectively. IACR rates were: 84.5 %/82.6 % (EAGLE-2) and 75.5 %/76.4 % (EAGLE-3) (post hoc analysis).

Conclusion

Differences in primary endpoint success criteria need to be considered when comparing contemporary and historic uUTI RCTs.

The trials are registered at Clinicaltrials.gov (EAGLE-2, NCT04020341; EAGLE-3, NCT04187144).

目的了解现行非劣效性随机对照试验（RCTs）对非复杂性尿路感染（uUTI）疗效结局的影响。方法seagle -2和EAGLE-3为临床3期非劣效性随机对照试验，对uUTI女性患者口服吉波替达素（1500mg，每日2次，连用5天）与呋喃妥因（100mg BID，连用5天）进行对照。复合（临床和微生物学）主要终点，治疗反应（成功或失败），在治愈试验（10-13天）对呋喃妥英敏感尿路病原体（≥105菌落形成单位/mL）的参与者进行评估。成功需要症状的解决和微生物的根除；缺少数据或额外使用抗菌药物被认为是失败的。EAGLE-2/ 3结果与历史呋喃妥因随机对照试验进行比较，探索性终点-症状“缓解或接近缓解”（仅剩下一种轻微症状）和研究者评估的临床反应(IACR) -被用作临床成功的替代指标。结果在不同终点的EAGLE-2/ 3组中，硝基呋喃妥英治疗成功率（47% / 44%）明显低于历史研究（61% - 94%）。基于症状“缓解或接近缓解”的临床成功率，吉波替达星/呋喃妥英分别为78.3% / 77.2% （EAGLE-2）和75.7% / 75.3% （EAGLE-3）。IACR率分别为84.5% / 82.6% （EAGLE-2）和75.5% / 76.4% (EAGLE-3)（事后分析）。结论：在比较当代和历史uUTI随机对照试验时，需要考虑主要终点成功标准的差异。这些试验已在Clinicaltrials.gov上注册（EAGLE-2, NCT04020341; EAGLE-3, NCT04187144）。

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引用次数: 0

Corrigendum to “Peer delivered, emotion regulation-focused mental health prevention training for fire fighter trainees: Design and methodology of a randomized controlled trial” [Contempor. Clinic. Trial. Commun. 47 (2025) 101537] 对“同伴提供的，以情绪调节为重点的消防员培训生心理健康预防培训：随机对照试验的设计和方法”的更正[当代]。诊所。审判。common . 47 (2025) 101537]

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101568

Eric C. Meyer , Todd Farchione , Nathan A. Kimbrel , Oi-Man Kwok , Michelle L. Pennington , Jessica Rostockyj , Suzy B. Gulliver

引用次数: 0