Contemporary clinical trials最新文献

{"title":"Assessing the effect of virtual navigation interventions to improve health insurance literacy and decrease financial burden in cancer survivors: The HINT II study protocol","authors":"Elyse R. Park ,&nbsp;Anne C. Kirchhoff ,&nbsp;Calli O. Mitchell ,&nbsp;Natalie Durieux ,&nbsp;Allyson Foor ,&nbsp;Karen Kuhlthau ,&nbsp;Giselle K. Perez ,&nbsp;Lakisa Ards ,&nbsp;Shani Alston ,&nbsp;Gregory T. Armstrong ,&nbsp;Perla L. Vaca Lopez ,&nbsp;Aaron McDonald ,&nbsp;Vikki G. Nolan ,&nbsp;Douglas E. Levy ,&nbsp;Wendy M. Leisenring ,&nbsp;Alison A. Galbraith ,&nbsp;Paul C. Nathan ,&nbsp;Chris Vukadinovich ,&nbsp;Christie L. Cooper ,&nbsp;Karen Donelan","doi":"10.1016/j.cct.2025.107952","DOIUrl":"10.1016/j.cct.2025.107952","url":null,"abstract":"<div><h3>Background</h3><div>Childhood cancer survivors often face high healthcare costs to monitor and manage new or lasting effects of their treatment. Enhancing survivors' health insurance literacy (HIL) – the knowledge, ability, and confidence in enrolling in and navigating health plans – is vital for minimizing financial burden. Few studies have assessed the effect of a health insurance navigation program on improving HIL among survivors. We present the protocol for an ongoing randomized controlled trial (RCT) assessing the effectiveness of two health insurance navigation programs (HINT-S and HINT-A) on improving HIL, financial burden, out-of-pocket costs, and healthcare utilization for adult survivors of childhood cancer.</div></div><div><h3>Methods</h3><div>This three-arm RCT assesses the effectiveness of two digitally delivered health insurance navigation interventions and enhanced usual care (EUC) on improving HIL at six and 12 months in a national cohort of childhood cancer survivors. While HINT-S is composed of five synchronous, navigator-led sessions, HINT-A is an asynchronous, prerecorded set of five videos. EUC participants receive only a health insurance informational booklet. Financial burden, medical out-of-pocket costs, and healthcare utilization (receipt of preventive care, recommended screenings/vaccinations, and acute care) are assessed at 12 months. Moderators to the interventions' effectiveness will be investigated, as well as implementation outcomes (feasibility, acceptability, appropriateness, fidelity, and cost-effectiveness).</div></div><div><h3>Conclusions</h3><div>There is a strong need for interventions to improve cancer survivors' HIL, helping them navigate the complexity of the U.S. healthcare system. This trial will elucidate the potential effectiveness and implementation of health insurance navigation programs that may benefit many cancer survivors.</div><div>Trial registration: <span><span>NCT05527392</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107952"},"PeriodicalIF":2.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized trial of a digital therapeutics intervention to enhance affective response during physical activity: Protocol for the eMOTION study","authors":"Genevieve F. Dunton ,&nbsp;Lori Hatzinger ,&nbsp;Rachel Crosley-Lyons ,&nbsp;Micaela Hewus ,&nbsp;Wei-Lin Wang ,&nbsp;Delfien Van Dyck ,&nbsp;Jimi Huh","doi":"10.1016/j.cct.2025.107945","DOIUrl":"10.1016/j.cct.2025.107945","url":null,"abstract":"<div><div>Physical activity interventions often fail to address features of physical activity that may lead to maintaining behavior, such as emotional experiences during behavior. Although some people experience pleasure during physical activity, it can be extremely unpleasant for others. Affective mechanisms (e.g., affective responses during behavior, anticipated affect about future behavior, affectively-charged motivations for future behavior) can influence the likelihood of engaging in future behavior. Using an experimental medicine approach, this Phase 1 trial of the eMOTION intervention aims to test whether affective mechanisms can be experimentally manipulated in real-world settings and whether affective mechanisms mediate the intervention effects on physical activity behavior. Pathways will be tested through a daily digital therapeutics intervention delivered using interactive mobile technology among physically inactive adults with overweight or obesity. An affect-based condition will provide daily goals related to enjoyment and feeling good during physical activity. In contrast, an intensity-based condition will provide daily goals for heart rate targets to achieve during physical activity. Two enhancements to the affect-based condition are: (1) tailored activity type and context recommendations to satisfy personally important psychological needs and (2) savoring practices to increase the saliency of positive emotions during physical activity. An 18-week study will optimize the treatment effects using a factorial (within x between) cross-over design (<em>N</em> = 280). Affective mechanisms and physical activity will be measured using real-time ecological momentary assessment (EMA) and accelerometry, respectively. Overall, this study fulfills an explicit need for the systematic translation of basic behavioral science processes into health behavioral change strategies through early-stage intervention development.</div><div>Trial Registration Number: <span><span>NCT06570642</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107945"},"PeriodicalIF":2.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of Mediterranean and Western diets on fatigue in patients with autoimmune hepatitis: Protocol for a randomized crossover diet intervention trial","authors":"Craig Lammert ,&nbsp;Siri Vuppalanchi ,&nbsp;Kelsey Green ,&nbsp;Nadia Blessing ,&nbsp;Archita P Desai ,&nbsp;Timothy Stump ,&nbsp;Nana Gletsu Miller ,&nbsp;Lisa Spence ,&nbsp;Amy Wright","doi":"10.1016/j.cct.2025.107951","DOIUrl":"10.1016/j.cct.2025.107951","url":null,"abstract":"<div><h3>Background</h3><div>Fatigue is a debilitating symptom in patients with autoimmune hepatitis (AIH), and no effective treatment interventions are currently available. The anti-inflammatory properties of a Mediterranean diet (MD) may offer a potential non-pharmacological approach to reducing fatigue. This paper outlines the rationale, design, and protocol for a randomized crossover diet intervention trial to assess the effects of Mediterranean diet (MD) compared to a Western diet (WD) on fatigue levels in patients with AIH.</div></div><div><h3>Methods</h3><div>In this crossover study, 48 subjects will be randomized to start either a MD or WD arm. After completing the initial arm, participants will switch to the opposite diet. The study team (including the PI and coordinator) and patients will remain blinded to the dietary intervention. The primary outcome will be the change in the fatigue component score of the PROMIS®-29 Profile v.2.0 survey during each dietary intervention. Secondary outcomes include changes in individual PROMIS-29 domain scores, mental and physical summary scores, circulating markers of inflammation (C-reactive protein and others), key liver serum biomarker levels (alanine aminotransferase, immunoglobulin G, total protein), stool microbiome (16S) and short-chain fatty acids, liver stiffness and steatosis, serum iron studies (ferritin, total iron binding capacity, transferrin saturation, hemoglobin), and nutritional markers such as serum vitamin D and magnesium levels.</div></div><div><h3>Conclusion</h3><div>If the Mediterranean diet (MD) is associated with a statistically significant decrease in the fatigue component score of the PROMIS®-29 survey, it could serve as a promising non-pharmacological intervention to reduce fatigue in AIH patients, offering a novel approach to improve quality of life in this population.</div><div>ClinicalTrials.gov ID: <span><span>NCT06250309</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107951"},"PeriodicalIF":2.0,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized, placebo-controlled trial of injectable extended-release naltrexone and injectable extended-release buprenorphine for cocaine use disorder (CURB-2): Study rationale and design","authors":"Madhukar H. Trivedi ,&nbsp;Mariah M. Kalmin ,&nbsp;Thomas Carmody ,&nbsp;Edward M. Chongsi ,&nbsp;Udi E. Ghitza ,&nbsp;Manish K. Jha ,&nbsp;Taryn L. Mayes ,&nbsp;Angela Casey-Willingham ,&nbsp;Sangita Sethuram ,&nbsp;Elise N. Marino ,&nbsp;Maria Monastirsky ,&nbsp;Steven J. Shoptaw","doi":"10.1016/j.cct.2025.107954","DOIUrl":"10.1016/j.cct.2025.107954","url":null,"abstract":"<div><h3>Background</h3><div>Cocaine remains the most abused stimulant, causing considerable morbidity and mortality. Despite decades of research, there is no FDA-approved medication to treat cocaine use disorder (CUD). In individuals with cocaine and opioid dependence/abuse, extended-release injectable naltrexone (XR-NTX) and sublingual buprenorphine (BUP; 16 mg with naloxone; Suboxone) reduced cocaine use compared to placebo and XR-NTX in the ‘Cocaine Use Reduction with Buprenorphine’ (CURB; CTN-0048) study.</div></div><div><h3>Objectives</h3><div>The CURB-2 (CTN-0109) study aims to examine whether administering XR-NTX in combination with extended-release injectable buprenorphine (XR-BUP), thus creating a “kappa antagonist,” is an effective pharmacotherapy compared to placebo for the treatment of CUD.</div></div><div><h3>Study design</h3><div>CURB-2 is a fully powered, phase IIb, randomized, placebo-controlled trial. Approximately 426 participants will be randomized across 12 study sites in the United States. There will be a 1-week medication induction phase, an 8-week active medication phase, and a 4-week follow-up phase. XR-NTX (Day 1, Week 3, Week 6) will be administered before XR-BUP (Day 4, Week 4). With naltrexone blocking the mu-opioid receptors, the reinforcing effects of buprenorphine will be blocked while leaving the kappa antagonist effects.</div></div><div><h3>Discussion</h3><div>If this kappa antagonist approach demonstrates efficacy in reducing urine-verified cocaine use compared to placebo, XR-NTX and XR-BUP combination therapy would be an important tool in addressing cocaine use disorder.</div><div>Clinical Trials Registration: <span><span>https://clinicaltrials.gov/ct2/show/NCT05262270</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107954"},"PeriodicalIF":2.0,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143947451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A clinical trial evaluating pharmacist-guided self-management of hypertension among veterans with CKD, rationale and study design","authors":"Mary Good ,&nbsp;Rachael Hoskins ,&nbsp;Brian C. Lund ,&nbsp;Patrick Ten Eyck ,&nbsp;Bradley Dixon ,&nbsp;Jordana Cohen ,&nbsp;Heather Reisinger Schact ,&nbsp;Korey Kennelty ,&nbsp;Diana Jalal","doi":"10.1016/j.cct.2025.107950","DOIUrl":"10.1016/j.cct.2025.107950","url":null,"abstract":"<div><h3>Rationale &amp; objective</h3><div>Chronic kidney disease (CKD) associates with high morbidity and mortality due to CKD progression and cardiovascular disease (CVD). Blood pressure (BP) lowering reduces the risk of CVD and CKD progression. Despite the large number of BP medications available, a significant proportion of patients with CKD have BP above the goal. The current practice involves licensed providers performing medication titrations to achieve BP goals and is associated with limited patient engagement. Here, we evaluate the effectiveness of pharmacist-guided patient-driven titration of BP medications in CKD.</div></div><div><h3>Study design</h3><div>Randomized clinical trial.</div></div><div><h3>Setting &amp; participants</h3><div>One hundred and sixty Veterans with uncontrolled hypertension and either stage 2 CKD with albuminuria or stage 3 or 4 CKD are recruited from the Iowa City VA Healthcare system.</div></div><div><h3>Interventions</h3><div>Subjects are randomized to the pharmacist self-guided management arm or the self-monitoring arm for 12 months.</div></div><div><h3>Outcomes</h3><div>This is a mixed methods study. The primary outcome is change in standardized office systolic BP at 12 months. Secondary outcomes include change in standardized office diastolic BP, change in home systolic and diastolic BPs, change in conventional office systolic and diastolic BPs, and emergency room visits for uncontrolled hypertension or hypertensive emergency. The study team will conduct semi-structured interviews to evaluate the acceptability and the adherence to the self-management approach to Veterans and to assess potential barriers and facilitators to implementation of the self-management approach.</div></div><div><h3>Trial Registration</h3><div><span><span>NCT05546099</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107950"},"PeriodicalIF":2.0,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Brain-targeted goal-directed therapy in high-risk patients undergoing major elective surgery: Study protocol for the BRAIN-PROMISE randomized trial","authors":"Massimiliano Greco ,&nbsp;Giulio Calgaro ,&nbsp;Mattia Cavallo ,&nbsp;Sara Pugliese ,&nbsp;Marta Mascari ,&nbsp;Fabio Piccirillo ,&nbsp;Andrea Pradella ,&nbsp;Federico Piccioni ,&nbsp;Maurizio Cecconi","doi":"10.1016/j.cct.2025.107940","DOIUrl":"10.1016/j.cct.2025.107940","url":null,"abstract":"<div><h3>Background</h3><div>Perioperative complications can lead to increased morbidity and mortality, diminished patient's quality of life, and substantial economic burden. Elderly and frail patients are particularly vulnerable, facing higher risks of postoperative cognitive dysfunction and delirium.</div><div>Perioperative choices and anaesthesia management, including hemodynamic monitoring, anaesthesia depth, and fluid therapy can significantly impact long-term outcomes. Near-infrared spectroscopy (NIRS) is a technique for measuring regional oxygen saturation of brain tissue (rSO2) during surgery. Monitoring cerebral perfusion through rSO2 could estimate perfusion changes, identify early tissue hypoxia, and mitigate postoperative complications. Nonetheless, there is a lack of studies exploring NIRS-based hemodynamic optimization protocols in high-risk surgical populations.</div></div><div><h3>Object</h3><div>This prospective randomized controlled trial has been designed to evaluate whether NIRS-targeted goal-directed therapy can reduce rSO2 drop episodes and improve outcomes in high-risk elderly patients undergoing major surgery.</div></div><div><h3>Methods</h3><div>This randomized controlled trial will enroll hypertensive elderly patients aged ≥65 or with a clinical frailty score ≥ 5, undergoing moderate to high-risk surgery under general anaesthesia. Participants will be randomized 1:1 to either NIRS-targeted management or standard care, with NIRS monitoring applied to both groups but only guiding intervention in the experimental group, and with anesthesiologist blinded to NIRS value in control group. Primary outcomes include the overall incidence of perioperative complications at 30 days, secondary outcomes assess cognitive dysfunction, delirium, length of stay and mortality at 90 days.</div></div><div><h3>Conclusions</h3><div>This study presents an innovative approach on the effectiveness of NIRS-targeted goal directed for improving perioperative outcomes in high-risk elderly patients undergoing general anaesthesia.</div><div>Trial registration: <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> registration, n. <span><span>NCT04266574</span><svg><path></path></svg></span>,</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107940"},"PeriodicalIF":2.0,"publicationDate":"2025-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143912586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing the role of correlation between efficacy and toxicity endpoints in the performance of Bayesian optimal phase II design","authors":"Xun Xu ,&nbsp;Ying Yuan ,&nbsp;J. Jack Lee","doi":"10.1016/j.cct.2025.107939","DOIUrl":"10.1016/j.cct.2025.107939","url":null,"abstract":"<div><div>Bayesian optimal phase II (BOP2) design serves to screen the efficacy and/or toxicity of a new treatment, determining whether it warrants further development. When employing the BOP2 design to jointly monitor the efficacy-toxicity tradeoff, the correlation between them plays an important role in achieving good performance on the statistical power while controlling Type I error. However, in practice, this correlation is usually unknown, posing challenges in the trial design and data analysis. In this study, the phi coefficient is chosen to measure the correlation. The influence of the efficacy-toxicity tradeoff on the power of BOP2 designs is first evaluated in the design stage and the data analysis stage, separately, then, overall considerations are given. In the design stage, we observe that the power increases as phi increases. Upon performing the sensitivity analysis in the data analysis stage, we find that the power decreases as phi increases given the pre-determined stopping boundaries. Simulations demonstrate instances of overpowering with inflated Type I error when the assumed phi in the design stage exceeds the true phi in the data analysis stage. Conversely, underpowering occurs with controlled Type I error when the assumed phi is lower than the true phi in the data analysis stage. To obtain the power under controlled Type I error in design, we recommend the use of independent correlation when the efficacy and toxicity are likely to be positively correlated. Conversely, for cases of likely negative correlation, taking a phi value close to the lower bound is advisable.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107939"},"PeriodicalIF":2.0,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143935760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Promoting mental health treatment initiation of veterans with PTSD using internet-based family training and telephone coaching: Protocol for a randomized controlled trial","authors":"Eric Kuhn ,&nbsp;Steven Sayers ,&nbsp;Lindsey Zimmerman ,&nbsp;Margaret-Anne Mackintosh ,&nbsp;Jason E. Owen ,&nbsp;Craig S. Rosen ,&nbsp;Laura A. Meis ,&nbsp;Hildi J. Hagedorn ,&nbsp;Christopher R. Erbes","doi":"10.1016/j.cct.2025.107929","DOIUrl":"10.1016/j.cct.2025.107929","url":null,"abstract":"<div><h3>Background</h3><div>Many veterans with posttraumatic stress disorder (PTSD) do not seek mental health care. Their significant others, including spouses and intimate partners, could be helpful in encouraging them to enter treatment. Community reinforcement and family training (CRAFT) has been shown to increase uptake in care among treatment-resistant individuals with alcohol and substance use disorders. We have adapted CRAFT for family members of veterans with PTSD and self-guided web-delivery with telephone coaching. A pilot study of this program showed promising results.</div></div><div><h3>Methods</h3><div>This paper describes a randomized controlled trial of the Veterans Affairs-CRAFT (VA-CRAFT) web program coupled with four telephone coaching calls from VA's Coaching Into Care (CIC) program compared to CIC as usual. Assessments will occur at baseline, posttreatment (3-mos.), and follow-up (6-mos.). Spouses and intimate partners of veterans with perceived, untreated PTSD (<em>N</em> = 230) will be randomized (1:1) to study conditions. We hypothesize that compared to CIC as usual, CIC + VA-CRAFT will result in more veterans initiating mental health care (Aim 1) without compromising CIC's existing high client satisfaction (Aim 2). We also will explore if participants show improved benefits in wellbeing in CIC + VA-CRAFT relative to CIC as usual (Exploratory Aim 1). Lastly, we will explore potential mediators and moderators of intervention effects (Exploratory Aim 2).</div></div><div><h3>Conclusion</h3><div>We expect results of this innovative trial will provide efficacy evidence for VA-CRAFT plus telephone coaching. If successful, findings can help support implementation efforts of VA-CRAFT into family services for veterans with PTSD who are reluctant to seek care.</div><div>Clinical Trial Registration Number: <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT04501328</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107929"},"PeriodicalIF":2.0,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143955687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of cyclic daytime versus continuous enteral nutrition on circadian rhythms in critical illness (CIRCLES): Study protocol for a randomized controlled trial","authors":"Floor W. Hiemstra ,&nbsp;Marit F. van Gent ,&nbsp;Evert de Jonge ,&nbsp;David J. van Westerloo ,&nbsp;Laura Kervezee","doi":"10.1016/j.cct.2025.107927","DOIUrl":"10.1016/j.cct.2025.107927","url":null,"abstract":"<div><h3>Background</h3><div>Circadian rhythms and sleep are often disrupted in critically ill patients in the intensive care unit (ICU), which has been linked to poor clinical outcomes. Feeding-fasting cycles serve as a synchronizing cue for the circadian timing system, indicating that optimizing these cycles in the ICU could reinforce circadian rhythms. The CIRCLES trial evaluates whether cyclic daytime enteral nutrition improves 24-h rhythms in critically ill patients compared to continuous enteral nutrition.</div></div><div><h3>Objective</h3><div>To describe the study protocol for the CIRCLES study.</div></div><div><h3>Study design</h3><div>The CIRCLES study is an investigator-initiated randomized controlled trial in a tertiary care ICU in the Netherlands. Patients (aged ≥18 years) admitted to the ICU with an expected stay ≥48 h receiving or with intention to start enteral nutrition are eligible for inclusion. Patients (<em>n</em> = 60) are randomized to the <em>continuous</em> enteral nutrition (nutrition around the clock) or <em>cyclic</em> daytime enteral nutrition group (nutrition between 08:00 h to 20:00 h).</div></div><div><h3>Main outcome measures</h3><div>The primary outcome is the amplitude of 24-h rhythms in core body temperature. Secondary outcomes include 24-h rhythms in heart rate, mean blood pressure heart rate variability, melatonin and gene expression, glucose regulation, insulin administration, caloric intake and feeding intolerance.</div></div><div><h3>Conclusion</h3><div>We hypothesize that a cyclic daytime feeding strategy will result in a higher amplitude of 24-h rhythms in vital signs, heart rate variability, and melatonin, compared to continuous feeding, thereby suggesting improved circadian rhythm strength. This study aims to provide insight into strategies to optimize circadian rhythms in ICU patients.</div></div><div><h3>Trial registration</h3><div>Registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT05795881</span><svg><path></path></svg></span>), April 2023.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107927"},"PeriodicalIF":2.0,"publicationDate":"2025-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143899630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving data credibility in online recruitment: Signs and strategies for detecting fraudulent participants when using ResearchMatch","authors":"Lauren M. Pageau,&nbsp;Jiying Ling","doi":"10.1016/j.cct.2025.107925","DOIUrl":"10.1016/j.cct.2025.107925","url":null,"abstract":"<div><h3>Introduction</h3><div>Online recruitment platforms are valuable tools that allow researchers to efficiently reach large pools of potential participants for clinical trials and observational studies. However, challenges associated with fraudulent respondents and bots threaten data credibility. This paper discusses signs we identified for recognizing potentially fraudulent respondents when using one online recruitment tool, ResearchMatch, to recruit study participants.</div></div><div><h3>Methods</h3><div>Participants were recruited via ResearchMatch for a study focused on stress and coping among U.S. young, low-income parents. Participants completed an online survey via Qualtrics. To screen for fraudulent respondents, we compared reports generated from Qualtrics with those from ResearchMatch.</div></div><div><h3>Results</h3><div>We identified six signs of fraudulent respondents, including 1) suspicious metadata, 2) fake addresses listed in ResearchMatch profile, 3) a common Western name for both first and last names, 4) inconsistent and duplicate data, 5) extensive list of medications and/or medical conditions, and 6) short survey completion time. We contacted 63,284 accounts through ResearchMatch and received 928 survey responses. About 46 % (<em>n</em> = 425) of responses were deemed fraudulent.</div></div><div><h3>Conclusions</h3><div>Fraudulent respondents and bots undermine the integrity of data, which may result in adverse implications for research, policy, and patient health. Given that nearly half of the survey respondents in our study were deemed fraudulent, it is evident that this is a significant issue for recruiting research participants via online recruitment platforms. To ensure reliability and accuracy of study findings, it is critical for researchers to thoroughly examine their data for signs of fraudulence.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"154 ","pages":"Article 107925"},"PeriodicalIF":2.0,"publicationDate":"2025-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143886426","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}