Contemporary Clinical Trials Communications最新文献

{"title":"Adjudication of a primary trial outcome: Results of a calibration exercise and protocol for a large international trial","authors":"Deborah Cook ,&nbsp;Adam Deane ,&nbsp;Joanna C. Dionne ,&nbsp;François Lauzier ,&nbsp;John C. Marshall ,&nbsp;Yaseen M. Arabi ,&nbsp;M. Elizabeth Wilcox ,&nbsp;Marlies Ostermann ,&nbsp;Abdulrahman Al-Fares ,&nbsp;Diane Heels-Ansdell ,&nbsp;Nicole Zytaruk ,&nbsp;Lehana Thabane ,&nbsp;Simon Finfer ,&nbsp;for the REVISE Investigators and the Canadian Critical Care Trials Group","doi":"10.1016/j.conctc.2024.101284","DOIUrl":"10.1016/j.conctc.2024.101284","url":null,"abstract":"<div><h3>Background</h3><p>Ascertainment of the severity of the primary outcome of upper gastrointestinal (GI) bleeding is integral to stress ulcer prophylaxis trials. This protocol outlines the adjudication process for GI bleeding events in an international trial comparing pantoprazole to placebo in critically ill patients (REVISE: <u>R</u>e-<u>Ev</u>aluating the Inhibition of <u>S</u>tress <u>E</u>rosions). The primary objective of the adjudication process is to assess episodes submitted by participating sites to determine which fulfil the definition of the primary efficacy outcome of clinically important upper GI bleeding. Secondary objectives are to categorize the bleeding severity if deemed not clinically important, and adjudicate the bleeding site, timing, investigations, and treatments.</p></div><div><h3>Methods</h3><p>Research coordinators follow patients daily for any suspected clinically important upper GI bleeding, and submit case report forms, doctors' and nurses’ notes, laboratory, imaging, and procedural reports to the methods center. An international central adjudication committee reflecting diverse specialty backgrounds conducted an initial calibration exercise to delineate the scope of the adjudication process, review components of the definition, and agree on how each criterion will be considered fulfilled. Henceforth, bleeding events will be stratified by study drug, and randomly assigned to adjudicator pairs (blinded to treatment allocation, and study center).</p></div><div><h3>Results</h3><p>Crude agreement, chance-corrected agreement, or chance-independent agreement if data have a skewed distribution will be calculated.</p></div><div><h3>Conclusions</h3><p>Focusing on consistency and accuracy, central independent blinded duplicate adjudication of suspected clinically important upper GI bleeding events will determine which events fulfil the definition of the primary efficacy outcome for this stress ulcer prophylaxis trial.</p></div><div><h3>Registration</h3><p>NCT03374800 (REVISE: <u>R</u>e-<u>Ev</u>aluating the Inhibition of <u>S</u>tress <u>E</u>rosions)</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000310/pdfft?md5=723dcea2f15ec43d36fb76712afd741c&pid=1-s2.0-S2451865424000310-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140086221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analyzing population-level trials as N-of-1 trials: An application to gait","authors":"Lin Zhou ,&nbsp;Juliana Schneider ,&nbsp;Bert Arnrich ,&nbsp;Stefan Konigorski","doi":"10.1016/j.conctc.2024.101282","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101282","url":null,"abstract":"<div><p>Studying individual causal effects of health interventions is important whenever intervention effects are heterogeneous between study participants. Conducting N-of-1 trials, which are single-person randomized controlled trials, is the gold standard for their analysis. As an alternative method, we propose to re-analyze existing population-level studies as N-of-1 trials, and use gait as a use case for illustration. Gait data were collected from 16 young and healthy participants under fatigued and non-fatigued, as well as under single-task (only walking) and dual-task (walking while performing a cognitive task) conditions. As a reference to the N-of-1 trials approach, we first computed standard population-level ANOVA models to evaluate differences in gait parameters (stride length and stride time) across conditions. Then, we estimated the effect of the interventions on gait parameters on the individual level through Bayesian repeated-measures models, viewing each participant as their own trial, and compared the results. The results illustrated that while few overall population-level effects were visible, individual-level analyses revealed differences between participants. Baseline values of the gait parameters varied largely among all participants, and the effects of fatigue and cognitive task were also heterogeneous, with some individuals showing effects in opposite directions. These differences between population-level and individual-level analyses were more pronounced for the fatigue intervention compared to the cognitive task intervention. Following our empirical analysis, we discuss re-analyzing population studies through the lens of N-of-1 trials more generally and highlight important considerations and requirements. Our work encourages future studies to investigate individual effects using population-level data.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000292/pdfft?md5=531ced59354f9bc2fa73f904b652031b&pid=1-s2.0-S2451865424000292-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140061808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influences on clinical trial participation: Enhancing recruitment through a gender lens - A scoping review","authors":"Lyndon J. Hawke ,&nbsp;Elizabeth Nelson ,&nbsp;Penny O'Brien ,&nbsp;Kay M. Crossley ,&nbsp;Peter F. Choong ,&nbsp;Samantha Bunzli ,&nbsp;Michelle M. Dowsey","doi":"10.1016/j.conctc.2024.101283","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101283","url":null,"abstract":"<div><h3>Background</h3><p>Suboptimal clinical trial recruitment contributes to research waste. Evidence suggests there may be gender-based differences in willingness to participate in clinical research. Identifying gender-based differences impacting the willingness of trial participation may assist trial recruitment.</p></div><div><h3>Objectives</h3><p>To examine factors that influence the willingness of men and women to participate in clinical trials and to identify modifiable factors that may be targeted to optimise trial participation.</p></div><div><h3>Material and methods</h3><p>Electronic databases were searched with key words relating to ‘gender’, ‘willingness to participate’ and ‘trial’. Included studies were English language and reported gender-based differences in willingness to participate in clinical trials, or factors that influence a single gender to participate in clinical trials. Studies were excluded if they described the demographic factors of trial participants or if the majority of participants were pregnant. Extracted data were coded, categorized, analysed thematically and interpreted using Arksey and O'Malley's framework.</p></div><div><h3>Results</h3><p>Sixty-three studies were included. Two main themes were identified: trial characteristics and participant characteristics. A number of gender-based differences moderating willingness to participate were observed although only one, ‘concern for self’ was found to influence actual trial participation rates between genders.</p></div><div><h3>Conclusion</h3><p>The relationship between factors influencing willingness to participate in clinical trials is complex. The influence of gender on willingness to participate, while important, may be moderated by other factors including socioeconomic status, ethnicity and health condition. Exploring factors that influence willingness to participate specific to a study cohort likely offers the most promise to optimise trial recruitment of that cohort.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000309/pdfft?md5=d97a39bb1da01f0f8d356c083c5f4109&pid=1-s2.0-S2451865424000309-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140031065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Wearable activity tracker study exploring rheumatoid arthritis patients’ disease activity using patient-reported outcome measures, clinical measures, and biometric sensor data (the wear study)","authors":"Laura Stradford ,&nbsp;Jeffrey R. Curtis ,&nbsp;Patrick Zueger ,&nbsp;Fenglong Xie ,&nbsp;David Curtis ,&nbsp;Kelly Gavigan ,&nbsp;Cassie Clinton ,&nbsp;Shilpa Venkatachalam ,&nbsp;Esteban Rivera ,&nbsp;W. Benjamin Nowell","doi":"10.1016/j.conctc.2024.101272","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101272","url":null,"abstract":"<div><h3>Background</h3><p>Digital health studies using electronic patient reported outcomes (ePROs), wearables, and clinical data to provide a more comprehensive picture of patient health.</p></div><div><h3>Methods</h3><p>Newly initiated patients on upadacitinib or adalimumab for RA will be recruited from community settings in the Excellence NEtwork in RheumatoloGY (ENRGY) practice-based research network. Over the period of three to six months, three streams of data will be collected (1) linkable physician-derived data; (2) self-reported daily and weekly ePROs through the ArthritisPower registry app; and (3) biometric sensor data passively collected via wearable. These data will be analyzed to evaluate correlations among the three types of data and patient improvement on the newly initiated medication.</p></div><div><h3>Conclusions</h3><p>Results from this study will provide valuable information regarding the relationships between physician data, wearable data, and ePROs in patients newly initiating an RA treatment, and demonstrate the feasibility of digital data capture for Remote Patient Monitoring of patients with rheumatic disease.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S245186542400019X/pdfft?md5=f6c20f2fbc73fedc856f33042d174cb9&pid=1-s2.0-S245186542400019X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139999846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of a pharmacist-led, community group-based education programme in enhancing diabetes management: A multicentre randomised control trial","authors":"Kamarudin Ahmad ,&nbsp;Lawrence Anchah ,&nbsp;Chuo Yew Ting ,&nbsp;Su Ee Lim","doi":"10.1016/j.conctc.2024.101280","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101280","url":null,"abstract":"<div><h3>Aims</h3><p>This study presents a protocol for the Pharmacy Integrated Community Care (PICC) program, meticulously designed to enhance Hemoglobin A1c (HbA1c) levels and augment knowledge about diabetes mellitus (DM) among individuals diagnosed with Type 2 Diabetes Mellitus (T2DM) in the Sarawak State of Malaysia.</p></div><div><h3>Methods</h3><p>From 1 May to December 31, 2023, a prospective, multicenter, parallel-design randomised controlled trial will be conducted with two groups, each consisting of 47 participants. The intervention group will receive a structured, four-session group-based program guided by experienced pharmacists, focusing on medication adherence and diabetes management. The control group will follow the standard Diabetes Mellitus Adherence Clinic program. The primary outcomes of this study encompass enhancements in knowledge regarding diabetes medication management and adherence, followed by subsequent changes in HbA1c levels.</p></div><div><h3>Conclusions</h3><p>The successful implementation of the PICC program holds promise for enhancing health outcomes in the T2DM population, potentially leading to more effective diabetes management initiatives and better health practices in the community.</p></div><div><h3>Trial registration clinicaltrials.gov identifier</h3><p>NCT05106231.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000279/pdfft?md5=83868df506887e8e85c71818e2725397&pid=1-s2.0-S2451865424000279-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139986566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Support Through Remote Observation and Nutrition Guidance (STRONG), a digital health intervention to reduce malnutrition among pancreatic cancer patients: A study protocol for a pilot randomized controlled trial","authors":"Kea Turner ,&nbsp;Dae Won Kim ,&nbsp;Brian D. Gonzalez ,&nbsp;Laurence R. Gore ,&nbsp;Erin Gurd ,&nbsp;Jeanine Milano ,&nbsp;Diane Riccardi ,&nbsp;Margaret Byrne ,&nbsp;Mohammed Al-Jumayli ,&nbsp;Tiago Biachi de Castria ,&nbsp;Damian A. Laber ,&nbsp;Sarah Hoffe ,&nbsp;James Costello ,&nbsp;Edmondo Robinson ,&nbsp;Juskaran S. Chadha ,&nbsp;Sahana Rajasekhara ,&nbsp;Emma Hume ,&nbsp;Ryan Hagen ,&nbsp;Oliver T. Nguyen ,&nbsp;Nicole Nardella ,&nbsp;Pamela Hodul","doi":"10.1016/j.conctc.2024.101271","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101271","url":null,"abstract":"<div><h3>Background</h3><p>Malnutrition is a common and distressing condition among pancreatic cancer patients. Fewer than a quarter of pancreatic cancer patients receive medical nutrition therapy (MNT), important for improving nutritional status, weight maintenance, quality of life and survival. System, provider, and patient level barriers limit access to MNT. We propose to examine the feasibility of a 12-week multi-level, digital health intervention designed to expand MNT access among pancreatic cancer patients.</p></div><div><h3>Methods</h3><p>Individuals with advanced pancreatic cancer starting chemotherapy (N = 80) will be 1:1 randomized to the intervention or usual care. The Support Through Remote Observation and Nutrition Guidance (STRONG) intervention includes system-level (e.g., routine malnutrition and screening), provider-level (e.g., dietitian training and web-based dashboard), and patient-level strategies (e.g., individualized nutrition plan, self-monitoring of dietary intake via Fitbit, ongoing goal monitoring and feedback). Individuals receiving usual care will be referred to dietitians based on their oncologists’ discretion. Study assessments will be completed at baseline, 4-, 8-, 12-, and 16-weeks.</p></div><div><h3>Results</h3><p>Primary outcomes will be feasibility (e.g., recruitment, retention, assessment completion) and acceptability. We will collect additional implementation outcomes, such as intervention adherence, perceived usability, and feedback on intervention quality via an exit interview. We will collect preliminary data on outcomes that may be associated with the intervention including malnutrition, quality of life, treatment outcomes, and survival.</p></div><div><h3>Conclusion</h3><p>This study will advance our knowledge on the feasibility of a digital health intervention to reduce malnutrition among individuals with advanced pancreatic cancer. Trial registration: NCT05675059, registered on December 9, 2022.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000188/pdfft?md5=b7ffcf443fdc62d0a44a11f7b9572a87&pid=1-s2.0-S2451865424000188-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139992698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Muscle activity and rehabilitation in spinal stenosis (MARSS) after conservative therapy and surgical decompression with or without fusion: Protocol for a partially randomized patient preference trial on rehabilitation timing","authors":"Eduard Kurz ,&nbsp;Philipp Schenk ,&nbsp;Florian Brakopp ,&nbsp;Moritz Diers ,&nbsp;Oliver Klingel ,&nbsp;Stefan Bone ,&nbsp;Hans Jörg Meisel ,&nbsp;Karl-Stefan Delank ,&nbsp;Bernhard W. Ullrich","doi":"10.1016/j.conctc.2024.101273","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101273","url":null,"abstract":"<div><h3>Background</h3><p>Patients affected by lumbar spinal stenosis (LSS) suffer from a multifactorial degeneration of the lumbar spine resulting in narrowing of the neuroforamina and spinal canal, leading to various functional limitations. It remains unclear whether LSS patients after surgery would benefit from early post-operative rehabilitation, or if a delayed rehabilitation would be more advantageous. The purpose of this partially randomized patient preference trial is to evaluate the impact of post-operative rehabilitation timing as well as surgical intervention type on psychometric properties and functional outcomes in patients with LSS.</p></div><div><h3>Methods</h3><p>Data for this patient preference trial are collected before and after surgical (decompression only or decompression and fusion) and rehabilitative interventions as well as six, 12 and 24 months after completing rehabilitation. The study participants are patients diagnosed with LSS who are at least 18 years old. After a medical check-up, participants will complete patient-reported outcome measures (PAREMO-20, SIBAR, FREM-8, SF-12, SFI, ODI) and different functional assessments (functional reach test, loaded reach test, handgrip strength, standing balance control, 6-min walk test).</p></div><div><h3>Ethics and dissemination</h3><p>The results of this study will be published through peer-reviewed publications and scientific contributions at national and international conferences. This research has been approved by the Institutional Review Board of Martin Luther University Halle-Wittenberg (reference number: 2022-128).</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000206/pdfft?md5=84da957ce7ce49f9a35bd56e7ea1994c&pid=1-s2.0-S2451865424000206-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139944997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Using Bayesian hierarchical modeling for performance evaluation of clinical trial accrual for a cancer center","authors":"Xiaosong Shi ,&nbsp;Dinesh Pal Mudaranthakam ,&nbsp;Jo A. Wick ,&nbsp;David Streeter ,&nbsp;Jeffrey A. Thompson ,&nbsp;Natalie R. Streeter ,&nbsp;Tara L. Lin ,&nbsp;Joseph Hines II ,&nbsp;Matthew S. Mayo ,&nbsp;Byron J. Gajewski","doi":"10.1016/j.conctc.2024.101281","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101281","url":null,"abstract":"<div><h3>Introduction</h3><p>Slow patient accrual in cancer clinical trials is always a concern. In 2021, the University of Kansas Comprehensive Cancer Center (KUCC), an NCI-designated comprehensive cancer center, implemented the Curated Cancer Clinical Outcomes Database (C3OD) to perform trial feasibility analyses using real-time electronic medical record data. In this study, we proposed a Bayesian hierarchical model to evaluate annual cancer clinical trial accrual performance.</p></div><div><h3>Methods</h3><p>The Bayesian hierarchical model uses Poisson models to describe the accrual performance of individual cancer clinical trials and a hierarchical component to describe the variation in performance across studies. Additionally, this model evaluates the impacts of the C3OD and the COVID-19 pandemic using posterior probabilities across evaluation years. The performance metric is the ratio of the observed accrual rate to the target accrual rate.</p></div><div><h3>Results</h3><p>Posterior medians of the annual accrual performance at the KUCC from 2018 to 2023 are 0.233, 0.246, 0.197, 0.150, 0.254, and 0.340. The COVID-19 pandemic partly explains the drop in performance in 2020 and 2021. The posterior probability that annual accrual performance is better with C3OD in 2023 than pre-pandemic (2019) is 0.935.</p></div><div><h3>Conclusions</h3><p>This study comprehensively evaluates the annual performance of clinical trial accrual at the KUCC, revealing a negative impact of COVID-19 and an ongoing positive impact of C3OD implementation. Two sensitivity analyses further validate the robustness of our model. Evaluating annual accrual performance across clinical trials is essential for a cancer center. The performance evaluation tools described in this paper are highly recommended for monitoring clinical trial accrual.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000280/pdfft?md5=ff6bd5871d7cd8a61545f17f41326812&pid=1-s2.0-S2451865424000280-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139936198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of power training in older patients with multiple sclerosis on neurodegeneration, neuromuscular function, and physical function. A study protocol for the “power training in older multiple sclerosis patients (PoTOMS) randomized control trial","authors":"Tobias Gaemelke ,&nbsp;Christoffer Laustsen ,&nbsp;Peter Feys ,&nbsp;Lars Folkestad ,&nbsp;Marianne Skovsager Andersen ,&nbsp;Niklas Rye Jørgensen ,&nbsp;Marie-Louise Jørgensen ,&nbsp;Sune Nørhøj Jespersen ,&nbsp;Steffen Ringgaard ,&nbsp;Simon F. Eskildsen ,&nbsp;Ulrik Dalgas ,&nbsp;Lars G. Hvid","doi":"10.1016/j.conctc.2024.101279","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101279","url":null,"abstract":"<div><h3>Introduction</h3><p>Approximately one-third of all persons with multiple sclerosis (pwMS) are older, i.e., having an age ≥60 years. Whilst ageing and MS separately elicit deteriorating effects on brain morphology, neuromuscular function, and physical function, the combination of ageing and MS may pose a particular challenge. To counteract such detrimental changes, power training (i.e., a type of resistance exercise focusing on moderate-to-high loading at maximal intended movement velocity) presents itself as a viable and highly effective solution. Power training is known to positively impact physical function, neuromuscular function, as well as brain morphology. Existing evidence is promising but limited to young and middle-aged pwMS, with the effects of power training remaining to be elucidated in older pwMS.</p></div><div><h3>Methods</h3><p>The presented ‘Power Training in Older MS patients (PoTOMS)’ trial is a national, multi-center, parallel-group, randomized controlled trial. The trial compares 24 weeks of usual care(n = 30) to 24 weeks of usual care and power training (n = 30). The primary outcome is whole brain atrophy rate. The secondary outcomes include changes in brain micro and macro structures, neuromuscular function, physical function, cognitive function, bone health, and patient-reported outcomes.</p></div><div><h3>Ethics and dissemination</h3><p>The presented study is approved by The Regional Ethics Committee (reference number 1-10-72-222-20) and registered at the Danish Data Protection Agency (reference number 2016-051-000001). All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences independent of the results. The <span>www.clinicaltrials.gov</span><svg><path></path></svg> identifier is NCT04762342.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000267/pdfft?md5=58c93e642fe3b5f24ccf00dbbda3e87a&pid=1-s2.0-S2451865424000267-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139999873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Vitamin D and prebiotics for intestinal health in cystic fibrosis: Rationale and design for a randomized, placebo-controlled, double-blind, 2 x 2 trial of administration of prebiotics and cholecalciferol (vitamin D3) (Pre-D trial) in adults with cystic fibrosis","authors":"Alisa K. Sivapiromrat ,&nbsp;Pichatorn Suppakitjanusant ,&nbsp;Yanling Wang ,&nbsp;Chengcheng Hu ,&nbsp;Jose Binongo ,&nbsp;William R. Hunt ,&nbsp;Samuel Weinstein ,&nbsp;Ishaan Jathal ,&nbsp;Jessica A. Alvarez ,&nbsp;Benoit Chassaing ,&nbsp;Thomas R. Ziegler ,&nbsp;Andrew T. Gewirtz ,&nbsp;Vin Tangpricha","doi":"10.1016/j.conctc.2024.101278","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101278","url":null,"abstract":"<div><p>Individuals with cystic fibrosis (CF) have dysfunctional intestinal microbiota and increased gastrointestinal (GI) inflammation also known as GI dysbiosis. It is hypothesized that administration of high-dose cholecalciferol (vitamin D₃) together with a prebiotic (inulin) will be effective, and possibly additive or synergistic, in reducing CF-related GI and airway dysbiosis. Thus, a 2 x 2 factorial design, placebo-controlled, double-blinded, pilot and feasibility, clinical trial was proposed to test this hypothesis. Forty adult participants with CF were block-randomized into one of four groups: 1) high-dose oral vitamin D₃ (50,000 IU weekly) plus oral prebiotic placebo daily; 2) oral prebiotic (12 g inulin daily) plus oral placebo vitamin D₃ weekly; 3) combined oral vitamin D₃ weekly and oral prebiotic inulin daily; and 4) oral vitamin D₃ placebo weekly and oral prebiotic placebo. The primary endpoints included 12-week changes in the microbial bacterial communities, gut and airway microbiota richness and diversity before and after the intervention. This pilot study examined whether vitamin D₃ with or without prebiotics supplementation was feasible, changed airway and gut microbiota, and reduced dysbiosis, which in turn, may improve health outcomes and quality of life of patients with CF.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.5,"publicationDate":"2024-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000255/pdfft?md5=48749da6fdd0a776620d006d7aa6aca7&pid=1-s2.0-S2451865424000255-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139942309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}