Contemporary Clinical Trials Communications最新文献

{"title":"Efficacy, safety, and response predictors of Astragalus in patients with mild to moderate Alzheimer's disease: A study protocol of an assessor-blind, statistician-blind open-label randomized controlled trial","authors":"Yingzhe Cheng ,&nbsp;Lin Lin ,&nbsp;Peilin Huang ,&nbsp;Jiejun Zhang ,&nbsp;Xiaodong Pan","doi":"10.1016/j.conctc.2024.101339","DOIUrl":"10.1016/j.conctc.2024.101339","url":null,"abstract":"<div><h3>Background</h3><p>This pragmatic clinical trial aims to determine the efficacy and safety of add-on Astragalus membranaceus (AM) for cognition and non-cognition in patients with of mild to moderate Alzheimer's disease complicated with orthostatic hypotension in orthostatic hypotension, elucidate the underlying mechanisms, identify related response predictors, and explore effective drug components.</p></div><div><h3>Methods</h3><p>This is an add-on, assessor-blinded, parallel, pragmatic, randomized controlled trial. At least 66 adults with mild to moderate Alzheimer's disease (AD) and OH aged 50–85 years will be recruited. Participants will be randomized in a 1:1:1 ratio to receive 24 weeks of routine care or add-on low dose AM or add-on high dose AM group. The primary efficacy outcome will be measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale, Chinese version. Secondary efficacy outcome assessment will include neuropsychological tests, blood pressure, plasma biomarkers, multimodal electroencephalograms, and neuroimaging. Safety outcome measures will include physical examinations, vital signs, electrocardiography, laboratory tests (such as hematologic and blood chemical tests), and adverse event records.</p></div><div><h3>Ethics and dissemination</h3><p>This trial was approved and supervised by Fujian Medical University Union Hospital (2021KJCX040). Independent results, findings will be published in peer-reviewed journals and presented at national and international conferences.</p></div><div><h3>Trial registration number</h3><p>NCT05647473; <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000863/pdfft?md5=7f63c66918784b62d140cefe366f8439&pid=1-s2.0-S2451865424000863-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141848057","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":"Evaluating the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation in young female adults: Study protocol for a randomised controlled trial","authors":"Fumitake Yamaguchi ,&nbsp;Naoki Yoshinaga ,&nbsp;Miho Kuroki ,&nbsp;Rie Nakasone ,&nbsp;Hisanori Kenmotsu ,&nbsp;Toshio Ueno ,&nbsp;Yukihiro Yada ,&nbsp;Michikazu Nakai ,&nbsp;Yasuji Arimura","doi":"10.1016/j.conctc.2024.101342","DOIUrl":"10.1016/j.conctc.2024.101342","url":null,"abstract":"<div><h3>Introduction</h3><p>The essential oil of Shikuwasa (<em>Citrus depressa</em> Hayata) primarily contains limonene and γ-terpinene, which have potential applications in stress management and relaxation. However, the psychological or physiological relaxation effects of Shikuwasa essential oil on humans are still unknown. This study aims to investigate the short-term relaxation effects of Shikuwasa essential oil, one of the less-studied varieties, compared to inhaling odour-free air in young female adults.</p></div><div><h3>Methods</h3><p>and analysis: This study is a two-arm, parallel-group, open-label, randomised controlled superiority trial. Forty young female adults will be assigned with a 1:1 allocation ratio to either the Shikuwasa essential oil inhalation group or the odour-free air inhalation group. The primary outcome measure will be subjective tense arousal (subscale of the Japanese version of the University of Wales Institute of Science and Technology Mood Adjective Checklist). Secondary outcomes include objective measures: miosis rate and peripheral skin temperature for evaluating autonomic nervous activity, and cerebral blood flow (assessed using near-infrared spectroscopy) for evaluating central nervous activity. Since these objective outcome measures cannot be performed at the same time, we divide our experiment into three phases and participants will inhale sample vials for 2 min in each experiment. We will also evaluate individual preferences/impressions regarding inhaled samples and any adverse events.</p></div><div><h3>Ethics and dissemination</h3><p>The study protocol has been reviewed and approved by the Research Ethics Committee of the Faculty of Medicine, University of Miyazaki (reference no: I-0074). The findings of this study will be disseminated to academic and professional audiences via publications in peer-reviewed journals and presentations at academic conferences, and to the broader public via public talks and media/press releases. All study findings, whether negative or positive, will be reported.</p></div><div><h3>Trial registration</h3><p>UMIN Clinical Trials Registry (UMIN-CTR), UMIN000053914. Prospectively registered on March 20, 2024.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000899/pdfft?md5=57f5e2cf726cf19dce8cc1c7975ebb38&pid=1-s2.0-S2451865424000899-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141843662","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":"A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial","authors":"Corey R. Roos ,&nbsp;Jonathan Bricker ,&nbsp;Brian Kiluk ,&nbsp;Timothy J. Trull ,&nbsp;Sarah Bowen ,&nbsp;Katie Witkiewitz ,&nbsp;Hedy Kober","doi":"10.1016/j.conctc.2024.101338","DOIUrl":"10.1016/j.conctc.2024.101338","url":null,"abstract":"<div><h3>Background</h3><p>Poor long-term recovery outcomes after treatment (e.g., readmission to inpatient treatment) are common among individuals with substance use disorders (SUDs). In-person mindfulness-based treatments (MBTs) are efficacious for SUDs and may improve recovery outcomes. However, existing MBTs for SUD have limited public health reach, and thus scalable delivery methods are needed. A digitally-delivered MBT for SUDs may hold promise.</p></div><div><h3>Methods</h3><p>We recently developed Mindful Journey, a smartphone app-based adjunctive MBT for improving long-term recovery outcomes. In this paper, we present details on the app and describe the protocol for a single-site pilot feasibility randomized controlled trial of Mindful Journey. In this trial, individuals (n = 34) in an early phase of outpatient treatment for SUDs will be randomized to either treatment-as-usual (TAU) plus Mindful Journey, or TAU only. The trial will focus on testing the feasibility (e.g., engagement) and acceptability of the app (e.g., perceived usability and helpfulness for recovery), as well as feasibility of study procedures (e.g., assessment completion). The trial will incorporate ecological momentary assessment before and after treatment to assess mechanisms in real-time, including mindfulness, craving, difficulties with negative emotion regulation, and savoring. To examine the sensitivity to change of outcomes (substance use, substance-related problems, and psychological distress) and mechanism variables (noted above), we will test within-treatment-condition changes over time.</p></div><div><h3>Discussion</h3><p>The proposed pilot trial will provide important preliminary data on whether Mindful Journey is feasible and acceptable among individuals with SUDs.</p></div><div><h3>Trial registration</h3><p>ClinicalTrials.gov <span><span>NCT05109507</span><svg><path></path></svg></span>.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000851/pdfft?md5=8b9c39a1809d312a6431f26343de96d8&pid=1-s2.0-S2451865424000851-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141851849","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":"Music therapy with adults in the subacute phase after stroke: A study protocol","authors":"Theo Dimitriadis ,&nbsp;Mohammed A. Mudarris ,&nbsp;Dieuwke S. Veldhuijzen ,&nbsp;Andrea W.M. Evers ,&nbsp;Wendy L. Magee ,&nbsp;Rebecca S. Schaefer","doi":"10.1016/j.conctc.2024.101340","DOIUrl":"10.1016/j.conctc.2024.101340","url":null,"abstract":"<div><p>Stroke is a highly disabling condition, for which music therapy is regularly used in rehabilitation. One possible mechanism for the effects of music therapy is the motivational aspect of music, for example regarding treatment adherence based on improved mood. In this study, changes in motivation related to Neurologic Music Therapy (NMT) techniques during rehabilitation in the subacute phase after stroke will be investigated. Using a randomised within-subjects cross-over design, the effects of two NMT techniques and related motivational indices will be investigated. Data will be collected at three timepoints: baseline (TP1), after being randomised into groups and receiving NMT or standard care (TP2), and then at a third time point after the cross-over and having received both conditions (TP3). This design allows to counteract order effects, time effects due to spontaneous and/or nonlinear recovery, as well as single-subject comparisons in a relatively heterogeneous sample. Twenty adult participants who have experienced a supratentorial ischaemic or haemorrhagic stroke and are experiencing upper-limb impairments and/or cognitive deficits will be included. Behavioural measures of motor function, cognition, and quality of life will be collected, along with self-reported indices of overall motivation. The study outcomes will have implications for the understanding of the underlying mechanisms of music therapy in stroke recovery, more specifically regarding the relevance of motivational states in neurorehabilitation.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000875/pdfft?md5=b7c677fe85551fb8754862db21b5f323&pid=1-s2.0-S2451865424000875-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141962053","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":"Adjunctive methylphenidate extended release in patients with schizophrenia: Protocol of a single-centre fixed dose cross-over open-label trial to improve functional and cognitive outcomes","authors":"Naista Zhand ,&nbsp;David Attwood ,&nbsp;Alain Labelle ,&nbsp;Ridha Joober ,&nbsp;Carrie Robertson ,&nbsp;Philip D. Harvey","doi":"10.1016/j.conctc.2024.101337","DOIUrl":"10.1016/j.conctc.2024.101337","url":null,"abstract":"<div><h3>Background</h3><p>Cognitive symptoms, among the core symptoms of schizophrenia, are associated with poor functional outcome and burden of illness. To date, there is no effective pharmacological treatment for these symptom clusters. Augmentation with psychostimulants has been proposed as a potential treatment option.</p></div><div><h3>Objectives</h3><p>The present study aims to assess off-label use of adjunctive methylphenidate extended release (ER) in patients with schizophrenia who are stable on antipsychotic medications, and to assess its efficacy on functioning and cognitive outcome.</p></div><div><h3>Methods</h3><p>This is a single centre study at the Royal Ottawa Mental Health Centre. An open-label fixed dose controlled cross-over trial is planned. Eligible participants will be randomized into one of two arms of the study: 1) four weeks of add-on methylphenidate ER 36 mg, or 2) four weeks of treatment as usual. At 4 weeks, participants will switch arms. The duration of the study includes 8 weeks of treatment and a follow-up visit at 12 weeks. Primary outcome measures include tablet-based tests of functioning and cognition (VRFCAT and BAC) and will be administered at baseline and every 4 weeks. We are aiming to recruit a total of 24 participants.</p></div><div><h3>Expected outcomes</h3><p>The proposed project intends to assess a potential treatment option for cognitive deficits of schizophrenia, for which there are no recommendations by current treatment guidelines. The novelty and significance of the current study is that it investigates this intervention and assess applicability of it in a “real world setting” in a tertiary care hospital.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S245186542400084X/pdfft?md5=1b3b0f652acc51442c994db7050a36ff&pid=1-s2.0-S245186542400084X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141849428","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":"A clinical randomized trial: Effects of early application of sacubitril/valsartan on ventricular remodeling and prognosis in acute myocardial infarction patients","authors":"Zhengfeng Liu ,&nbsp;Kun Cui ,&nbsp;Guangdong Wang ,&nbsp;Wenqing Jin ,&nbsp;Qiong Yao ,&nbsp;Yuanzheng Zhang","doi":"10.1016/j.conctc.2024.101303","DOIUrl":"10.1016/j.conctc.2024.101303","url":null,"abstract":"<div><h3>Objectives</h3><div>To explore the effects of early application of sacubitril/valsartan on ventricular remodeling and prognosis in patients with acute myocardial infarction (AMI).</div></div><div><h3>Methods</h3><div>Total of 295 patients with AMI admitted to the hospital were enrolled between August 2019 and August 2021. According to different treatment methods, they were divided into observation group (sacubitril/valsartan sodium tables combined with standard treatment, 132 patients) and control group (benazepril hydrochloride tablets combined with standard treatment, 163 patients). The levels of plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), creatinine (Cr) and serum K⁺ before and at 6 months after treatment, standard deviation of all normal-to-normal intervals (SDNN), standard deviation of the average all normal-to-normal intervals (SDANN), root mean square of differences between adjacent normal-to-normal intervals/root mean square differences of successive R-R (RMSSD), left ventricular end-diastolic volume (LVEDV), left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV) in the two groups were compared. The adverse reactions during treatment and major adverse cardiac events (MACE) during 6 months of follow-up in both groups were statistically analyzed.</div></div><div><h3>Results</h3><div>The levels of NT-proBNP, Cr and K⁺, LVEDV and LVESV in observation group were significantly lower than those in control group (<em>P</em> &lt; 0.05), while LVEF, SDNN, SDANN and RMSSD were significantly higher than those in control group (<em>P</em> &lt; 0.05). The incidence of MACE in observation group was lower than that in control group during 6 months of follow-up (7.58 % <em>vs</em> 27.61 %, <em>P</em> &lt; 0.05), but there was no significant difference in the incidence of adverse reactions (9.85 % <em>vs</em> 12.88 %, <em>P</em> &gt; 0.05).</div></div><div><h3>Conclusion</h3><div>Early application of sacubitril/valsartan sodium can effectively delay ventricular remodeling, improve cardiac function and heart rate variability indexes, reduce NT-proBNP level and improve prognosis in AMI patients.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141851822","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":"Design and methodology of the first open-label trial of MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder: Considerations for a randomized controlled trial","authors":"Erica Eaton ,&nbsp;Christy Capone ,&nbsp;Brian J. Gully ,&nbsp;Zoe E. Brown ,&nbsp;Mollie Monnig ,&nbsp;Michael S. Worden ,&nbsp;Robert M. Swift ,&nbsp;Carolina L. Haass-Koffler","doi":"10.1016/j.conctc.2024.101333","DOIUrl":"10.1016/j.conctc.2024.101333","url":null,"abstract":"<div><h3>Background</h3><p>Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) commonly co-occur and are associated with more severe symptomatology than either disorder alone, increased risk of suicide, and poorer response to existing treatments. A promising therapeutic intervention is the integration of 3,4-methylenedioxymethamphetamine (MDMA) and psychotherapy. The Food and Drug Administration (FDA) designated MDMA- assisted therapy (MDMA-AT) as a Breakthrough Therapy for PTSD based on results from six Phase 2 clinical trials. Case data from the first study evaluating MDMA-AT study for AUD found the treatment was well tolerated and alcohol use was significantly reduced post treatment.</p></div><div><h3>Methods</h3><p>This manuscript reports the premise, design, and methodology of the first open-label trial of MDMA-AT for military veterans (<em>N</em> = 12) with PTSD and AUD. Neuroimaging and biomarker data are included to evaluate brain changes, and neuroinflammation, pre-post treatment.</p></div><div><h3>Conclusions</h3><p>The clinical component (comorbidity) and the regulatory processes (Schedule I drug) for setting up this clinical trial are long and complex. The research community will benefit from this work to establish common clinical trial outcomes, standardized protocols, and risk assessments for FDA approval.</p></div><div><h3>Clinicaltrials.gov</h3><p>NCT05943665.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000802/pdfft?md5=7b5c8a5a2fd718ced065c24d5ea121be&pid=1-s2.0-S2451865424000802-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141846431","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":"Balance chiropractic therapy for cervical spondylotic radiculopathy: A randomized controlled trial","authors":"Wenxiong Li ,&nbsp;Yaxin Chang ,&nbsp;Qi Feng ,&nbsp;Yan Cheng ,&nbsp;Jichao Yin ,&nbsp;Yindi Sun ,&nbsp;Feng Yang","doi":"10.1016/j.conctc.2024.101323","DOIUrl":"10.1016/j.conctc.2024.101323","url":null,"abstract":"<div><h3>Objective</h3><p>To assess the clinical effectiveness of the balance chiropractic therapy (BCT) compared with traction therapy (TT) for patients with cervical spondylotic radiculopathy.</p></div><div><h3>Methods</h3><p>Subjects were enrolled from four hospitals. Eligible patients will be randomized to one of the two arms: the treatment group and the control group. In the treatment group, patients received the BCT for 20 days, while patients in the control group received TT. Patients visited the physician at 1- and 3-month follow-up. The primary outcome was pain severity measured with a Visual Analog Scale (VAS). Secondary outcomes included cervical curvature measured using the Borden method, a composite of functional status measured by the Neck Disability Index (NDI), patient health status (evaluated by the SF-36 health survey) and adverse events (AEs) as reported in the trial.</p></div><div><h3>Results</h3><p>Of the 240 randomly assigned patients, 120 participants were assigned to the BCT and 120 to the TT. 231 (96.3 %) provided follow-up data at 1 and 3 months. There were no significant differences in baseline data between the two groups (P &gt; 0.05), indicating good comparability. According to the results, after BCT and TT treatment, the pain VAS score, cervical curvature, NDI scores and SF-36 scores of two groups was significantly improved (P &lt; 0.05). Furthermore, at 20 days of treatment and 1 and 3 months of follow-up, the participants in the BCT group showed superior treatment outcomes on both primary and secondary measures.</p></div><div><h3>Conclusion</h3><p>The BCT may be a novel strategy for the treatment of the cervical spondylotic radiculopathy.</p></div><div><h3>Trial registration</h3><p>Clinical <span><span>Trials.gov</span><svg><path></path></svg></span> Identifier: NCT02705131. Registered on March 10, 2016, <span><span>https://clinicaltrials.gov/study/NCT02705131?cond=NCT02705131&amp;rank=1&amp;tab=table</span><svg><path></path></svg></span>.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S245186542400070X/pdfft?md5=24e909b508fe76faab05185e8d3f0ff4&pid=1-s2.0-S245186542400070X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141692684","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":"The role of intermediaries in connecting individuals to local physical activity – protocol for a pilot feasibility trial","authors":"Megan O'Grady ,&nbsp;Deirdre Connolly ,&nbsp;Emer Barrett","doi":"10.1016/j.conctc.2024.101332","DOIUrl":"10.1016/j.conctc.2024.101332","url":null,"abstract":"<div><h3>Background</h3><p>Intermediaries are health-related workers who facilitate connections to local physical activities. Intermediaries deliver interventions by receiving referrals, conducting assessments, connecting referred individuals to activities and/or services in the community, and following up with them over time. However, it is unclear whether individuals who are referred to physical activities by an intermediary improve their physical activity levels, and what their perspectives and experiences are of participating in this intervention. To date there has been a lack of studies investigating the effect of this intervention on physical activity using appropriate outcome measures.</p></div><div><h3>Methods</h3><p>This will be a mixed methods pilot feasibility study. Participants will be individuals referred or self-referred to an intermediary and connected to local physical activities. Participants will be recruited through two types of intermediary services in Ireland; social prescribing and local sports partnerships. A total of 30 participants will be recruited (15 per service). Baseline demographic information will be taken upon enrolment to the study and three questionnaires will be completed: the International Physical Activity Questionnaire - Short Form, Self-Efficacy for Exercise Scale and Short Warwick Edinburgh Mental Well-being Scale. The questionnaires will be repeated after 12 weeks and in addition semi-structured interviews will be carried out to explore intervention content and delivery, as well as acceptability of the intervention and evaluation design.</p></div><div><h3>Discussion</h3><p>This overall aim of this proposed study is to investigate the feasibility of an intervention delivered by an intermediary to improve physical activity and health-related outcomes of community-dwelling individuals.</p></div><div><h3>Registration</h3><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT06260995).</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000796/pdfft?md5=5bc782ede55f24f14e41d4762450e826&pid=1-s2.0-S2451865424000796-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141709925","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":"Regulatory landscape with U.S. patient requirements and Clinical Trial Diversity expectations","authors":"Elizabeth George ,&nbsp;Alicia Baker McDowell ,&nbsp;Melissa Vozza ,&nbsp;Talley Mitchell ,&nbsp;Ben Quartley ,&nbsp;Cassandra S. Kennedy ,&nbsp;Bill Hanlon","doi":"10.1016/j.conctc.2024.101331","DOIUrl":"10.1016/j.conctc.2024.101331","url":null,"abstract":"<div><p>The Food and Drug Administration (FDA) has an expectation that products filed for marketing authorization have to include data that are representative of the US patient population. Any foreign clinical data that is submitted has to represent an ethnically diverse population that is generated utilizing qualified Principal Investigators (PIs) and conducted according to Good Clinical Practices (GCP) requirements outlined in 21 CFR 312.120, Foreign clinical studies not conducted under an IND. With the recent passing of the Omnibus Legislation, FDA now also has the authority to require Diversity Plans for all Phase 3 clinical trials of new drugs or “as appropriate, another pivotal study of a new drug.” The FDA has released a guidance document, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials” (April 2022), for the industry with expectations to update the document in 2023 now that legislation is passed. This whitepaper discusses the FDA guidance and expectations of sponsors with regards to foreign clinical data and the intersection with enrolling ethnically diverse populations in clinical studies.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":null,"pages":null},"PeriodicalIF":1.4,"publicationDate":"2024-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000784/pdfft?md5=4d1a90edb7c97686bc943dc17349a5f6&pid=1-s2.0-S2451865424000784-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141694919","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}