Contemporary Clinical Trials Communications最新文献

{"title":"Efficacy of a non-pharmaceutical multimodal intervention program in a group setting for patients with mild cognitive impairment: A single-arm interventional study with pre-post and external control analyses","authors":"Satoshi Nakagawa ,&nbsp;Hisatomo Kowa ,&nbsp;Yumi Takagi ,&nbsp;Yasumasa Kakei ,&nbsp;Tatsuo Kagimura ,&nbsp;Shoji Sanada ,&nbsp;Yoji Nagai","doi":"10.1016/j.conctc.2024.101326","DOIUrl":"10.1016/j.conctc.2024.101326","url":null,"abstract":"<div><h3>Aim</h3><p>This study aimed to evaluate the efficacy of a non-pharmaceutical multimodal intervention program consisting of physical exercise, cognitive stimulation, and health education in a group setting to slow the progression of mild cognitive impairment (MCI).</p></div><div><h3>Methods</h3><p>A single-arm interventional study was conducted on 27 patients with MCI. To evaluate the efficacy of the intervention program, a pre-post analysis was performed using EuroQol-5 Dimension (EQ-5D), Mini-Mental State Examination (MMSE), Cognitive Function Instrument (CFI), 5 Cog test, depression, and physical performance before and after the 8-month intervention. Additionally, propensity score and the semi-Bayes analyses were performed to compare the intervention program with standard medical care, using the external control patients’ data for MMSE scores.</p></div><div><h3>Results</h3><p>Twenty-four patients completed the intervention program. During the study period, although EQ-5D and MMSE scores remained unchanged (mean change 0.02 [95 % confidence interval (CI): −0.004, 0.04], 0.5 [-0.2, 1.3]), CFI and the subcategories of 5Cog (attention and reasoning) improved (mean change −1.23 [-2.24, −0.21], 4.3 [0.9, 7.7], 3.0 [0.4, 5.6]). In the additional analysis comparing changes in MMSE scores, patients who underwent the intervention program had less decline than the external control patients (mean change −1.7 [-2.1, −1.3]) with an observed mean difference of 2.25 [1.46, 3.03], and propensity score-adjusted difference of 2.26 [1.46, 3.05]. The semi-Bayesian approach also suggested that the intervention slowed the progression of MCI.</p></div><div><h3>Conclusion</h3><p>A non-pharmaceutical multimodal intervention program could contribute to slowing cognitive decline in patients with MCI.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"40 ","pages":"Article 101326"},"PeriodicalIF":1.4,"publicationDate":"2024-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000735/pdfft?md5=759ffd8e4f8aaf04cf854ce7639bb5bd&pid=1-s2.0-S2451865424000735-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141390511","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":"Detailed description of multidisciplinary prehabilitation in patients admitted to nerve sparring radical prostatectomy – A randomized feasibility study protocol","authors":"Malene Blumenau Pedersen ,&nbsp;John M. Saxton ,&nbsp;Brigitta Rasmussen Villumsen ,&nbsp;Jørgen Bjerggaard Jensen ,&nbsp;Sara Birch","doi":"10.1016/j.conctc.2024.101319","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101319","url":null,"abstract":"<div><h3>Background</h3><p>Localized prostate cancer treated with radical prostatectomy is highly effective, though severe side-effects are common after the surgery. Prehabilitation is an approach to optimize patient's physical and mental resources before surgery, to improve postoperative outcomes. The feasibility of a multi-modal home-based prehabilitation program, delivered using telehealth in patients awaiting radical prostatectomy is unknown. This paper describes the development of a prehabilitation program for patients awaiting radical prostatectomy.</p></div><div><h3>Method</h3><p>A model by The Medical Research Council for developing and evaluating complex interventions (MRC Framework) was used in the development process. The Template for Intervention Description and Replication (TIDieR) checklist was applied for ensuring sufficient description of the interventions. A total of 40 patients will be randomized to either intervention or control group. Patients in the control group will follow standard care. The 4-week prehabilitation programme consists of exercise, pelvic floor exercise, sexual counseling, stress management and nutritional support. The interventions are home-based and delivered using telehealth. Feasibility outcomes will include recruitment, attrition rates, adherence, safety and suitability.</p></div><div><h3>Conclusion</h3><p>We have developed a multimodal prehabilitation programme, which has the potential to bring tangible health benefits to men with prostate cancer awaiting radical prostatectomy. The results of the feasibility study will inform the design of a fully powered randomized controlled trial.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"40 ","pages":"Article 101319"},"PeriodicalIF":1.5,"publicationDate":"2024-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000668/pdfft?md5=5b701a1ae676fcea469c582f854c3f1e&pid=1-s2.0-S2451865424000668-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141314657","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":"Protocol for a feasibility randomized controlled trial of gentle yoga in older patients discharged from phase II cardiac rehabilitation","authors":"Geunyeong Cha ,&nbsp;Misook L. Chung ,&nbsp;Nicholas R. Heebner ,&nbsp;Ulf G. Bronas ,&nbsp;Martha J. Biddle ,&nbsp;Chin-Yen Lin ,&nbsp;JungHee Kang ,&nbsp;Jia-Rong Wu ,&nbsp;Jessica H. Thompson ,&nbsp;Ashmita Thapa ,&nbsp;Debra K. Moser","doi":"10.1016/j.conctc.2024.101320","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101320","url":null,"abstract":"<div><h3>Background</h3><p>Physical activity (PA) is essential following an acute cardiac event. Cardiac rehabilitation (CR) is commonly prescribed, and PA after CR is recommended. Because of age-related changes in functional ability and multi-comorbidity, many older cardiac patients struggle to continue performing PA at home after CR. Depressive symptoms and anxiety are prevalent in cardiac patients and associated with poor self-care, including lack of daily PA. Yoga has been demonstrated to improve psychological and physical health outcomes in cardiac patients, but it is unknown whether yoga, modified for older CR patients – Gentle Yoga – is beneficial in managing psychological distress and maintaining PA following phase II CR. Our specific aims are to:1) determine the feasibility and acceptability of a modified gentle yoga intervention delivered via video conferencing for older cardiac patients; 2) compare, at 3-month follow-up, the effects and determine effect sizes of a gentle yoga intervention versus control on psychological health and physical health.</p></div><div><h3>Methods</h3><p>We are conducting a 2-group (intervention versus control) randomized controlled pilot study. The intervention is a 12-week gentle yoga program delivered via video conference. Short-term effects will be evaluated at 3-month.</p></div><div><h3>Conclusion</h3><p>This study is designed to be suited for older cardiac patients who would not have access to supervised PA opportunities after facility-based CR to enhance PA. This study will provide data about the feasibility and acceptability of the protocol for older cardiac patients and will offer effect sizes to determine sample size for a fully powered randomized controlled trial.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"40 ","pages":"Article 101320"},"PeriodicalIF":1.5,"publicationDate":"2024-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S245186542400067X/pdfft?md5=3b01db9a44ae2f411ab5773253073135&pid=1-s2.0-S245186542400067X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141291347","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 IRIS clinic: A Protocol for a mixed-methods study evaluating the management of Hyperemesis Gravidarum","authors":"Eileen C. O'Brien ,&nbsp;Jean Doherty ,&nbsp;Sarah Louise Killeen ,&nbsp;Melanie Bennett ,&nbsp;Lillian Murtagh ,&nbsp;Sinead Curran ,&nbsp;Suzanne Murphy ,&nbsp;Helen McHale ,&nbsp;Lucille Sheehy","doi":"10.1016/j.conctc.2023.101227","DOIUrl":"10.1016/j.conctc.2023.101227","url":null,"abstract":"<div><h3>Background</h3><p>Hyperemesis Gravidarum (HG) is a severe form of nausea and vomiting in pregnancy that affects 0.3–3% of women and has profound nutritional, physical and psychological consequences. Research is lacking regarding the most effective management of the condition. In response to patient feedback, a multidisciplinary HG day-case service (IRIS Clinic) was launched in 2020 at The National Maternity Hospital, Ireland. The clinic provides routine, day-case care in a comfortable space with pre-booked appointments. The MDT involves midwives, dietitians, perinatal mental health, obstetrics and pharmacy, and the nature of the clinic enables peer-to-peer support. As this clinic is the first of its kind in Ireland, we aim to assess its effectiveness and feasibility, and suggest recommendations for improvement.</p></div><div><h3>Methods</h3><p>This is a sequential, mixed-methods study that commenced in August 2021. The prospective arm of the study is ongoing and involves enrolling women (n = 50) who are attending the IRIS clinic. Data are collected on first admission (pre-intervention) and approximately 8 weeks' later (post-intervention) relating to symptoms of HG, well-being, food tolerances, quality of life and nutritional intake. Qualitative, semi-structured interviews will be conducted to evaluate women's experiences of attending the clinic. The retrospective arm of the study will be a chart review (n = 200) of women diagnosed with HG to describe assessments, treatments and pregnancy and birth outcomes.</p></div><div><h3>Conclusion</h3><p>The IRIS clinic has the potential to improve pregnancy outcomes and nutritional status among women with HG. If found to be effective and feasible, the model for this clinic could be replicated elsewhere.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"39 ","pages":"Article 101227"},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865423001734/pdfft?md5=c01f5bf612dc3e7a6524833598a4e915&pid=1-s2.0-S2451865423001734-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135566920","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":"Sevoflurane multiple Wash In/Wash Out at the end of anesthesia to reduce agitation: A multicenter double-blind randomized controlled trial","authors":"Giovanni Landoni ,&nbsp;Valery V. Likhvantsev ,&nbsp;Levan B. Berikashvili ,&nbsp;Andrey G. Yavorovsky ,&nbsp;Pavel S. Bagdasarov ,&nbsp;Anastasia V. Smirnova ,&nbsp;Tatiana S. Serkova ,&nbsp;Valery V. Subbotin ,&nbsp;Kristina K. Kadantseva ,&nbsp;Alexey M. Ovezov ,&nbsp;Mikhail Ya Yadgarov ,&nbsp;Alexey A. Yakovlev ,&nbsp;Andrea Lamacchia ,&nbsp;Lorenzo Gallo ,&nbsp;Nadezhda D. Gracheva ,&nbsp;Pavel V. Ryzhkov ,&nbsp;Rachele Zilocchi ,&nbsp;Jessica De Vecchi ,&nbsp;Maksim A. Aleinikov ,&nbsp;Pavel S. Mayuk ,&nbsp;Maria M. Shemetova","doi":"10.1016/j.conctc.2024.101316","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101316","url":null,"abstract":"<div><h3>Background</h3><p>Postoperative agitation is common after non-cardiac surgery. It is associated with postoperative delirium and cognitive dysfunction, leading to prolonged hospital stay and delayed social readjustment. Prevention and treatment strategies are lacking. We assessed the efficacy of a novel approach, the Wash In/Wash Out procedure, in reducing post-anesthetic agitation.</p></div><div><h3>Methods</h3><p>This multicenter, parallel-group, double-blind randomized controlled trial is enrolling 200 patients undergoing open abdominal surgery. Participants are randomly assigned to either a control group receiving standard recovery methods or an investigational group undergoing the Wash In/Wash Out procedure. In the Wash In/Wash Out procedure group, sevoflurane is stopped and then promptly restarted when the patient shows the first signs of awakening to achieve an end-tidal concentration of 1 minimum alveolar concentration (MAC) for 5 min. This stop-and-restart cycle is performed three times. The trial's primary outcome is the rate of postoperative agitation. Secondary outcomes include rate of postoperative delirium and cognitive dysfunction, postoperative nausea and vomiting, and length of intensive care and hospital stay.</p></div><div><h3>Discussion</h3><p>The OPERA trial investigates the effect of the Wash In/Wash Out procedure to reduce post-anesthetic agitation in non-cardiac surgery. This study could offer a significant contribution to improving patient outcomes and optimizing recovery protocols in surgical settings.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"39 ","pages":"Article 101316"},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000632/pdfft?md5=e6edf3c960e2f8f6c8502ee65605d40e&pid=1-s2.0-S2451865424000632-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141242614","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 multidisciplinary approach on music induced-analgesia differentiated by socio-cultural background in healthy volunteers (MOSART): A cross-over randomized controlled trial protocol","authors":"Antonia S. Becker ,&nbsp;Emy S. van der Valk Bouman ,&nbsp;Julian Schaap ,&nbsp;Cecile C. de Vos ,&nbsp;Koen van Eijck ,&nbsp;Hans Jeekel ,&nbsp;Markus Klimek","doi":"10.1016/j.conctc.2024.101313","DOIUrl":"10.1016/j.conctc.2024.101313","url":null,"abstract":"<div><h3>Background</h3><p>Integrating music into pain treatment demonstrates significant benefits, effectively reducing subjective pain levels and perioperative opioid requirements. Currently, the relationship between the impact of specific types of music and listeners’ socio-cultural background is still unclear. This is especially relevant given that sociological research indicates that these factors can have a notable influence on music preference and perception. Current evidence suggests that individuals who choose their own music may experience greater benefits. However, additional research is needed to comprehensively grasp whether the effect of (preferred) music on pain endurance remains consistent across different socio-cultural backgrounds.</p></div><div><h3>Methods</h3><p>In this study, a collaborative effort between medical and sociological researchers aims to investigate music-induced analgesia differentiated by socio-cultural background in healthy volunteers. Participants (n = 84) will listen to self-, and researcher-chosen music and a podcast as a control condition in a cross-over study design. The primary outcome of this study is pain endurance measured by electric stimuli of increasing intensity. Detailed sociological validated questionnaires will be utilized. Considering the notable influence of educational level on music taste formation found in previous research and its crucial role as a source of socio-cultural differentiation, participants will be stratified based on their level of education.</p></div><div><h3>Discussion</h3><p>This experimental study represents one of the first efforts to gain a socio-culturally differentiated understanding of the therapeutic potential of music. Consequently, this could pave the way to purposefully and inclusively implement personalized music in healthcare settings.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"39 ","pages":"Article 101313"},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000607/pdfft?md5=04cd782c585f91e29a4d57b4052689ba&pid=1-s2.0-S2451865424000607-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141139199","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":"Corrigendum to “Design of a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of prucalopride in pediatric patients with functional constipation” [Contemp. Clin. Trials Commun. 33 (2023) 101144]","authors":"Carmen Cuffari ,&nbsp;William Spalding ,&nbsp;Heinrich Achenbach ,&nbsp;Manoj Thakur ,&nbsp;André Gabriel","doi":"10.1016/j.conctc.2024.101302","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101302","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"39 ","pages":"Article 101302"},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000498/pdfft?md5=4137f10c22df2a6c934a8909a4b6104d&pid=1-s2.0-S2451865424000498-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141314156","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":"Implementing regular physical activity for older individuals in the family strategy program using the RE-AIM framework to ensure feasibility and sustainability: EISI study protocol","authors":"Saulo Vasconcelos Rocha ,&nbsp;Clarice Alves dos Santos ,&nbsp;Ariani França Conceição ,&nbsp;Bruna Maria Palotino-Ferreira ,&nbsp;Danilo Barbosa Morais ,&nbsp;Félix Salvador Chavane ,&nbsp;Carolina Rego Chaves Dias ,&nbsp;André Luís Lacerda Bachi ,&nbsp;Rui Mendes ,&nbsp;Sónia Brito-Costa ,&nbsp;Sofia Silva ,&nbsp;Guilherme Eustáquio Furtado","doi":"10.1016/j.conctc.2024.101311","DOIUrl":"10.1016/j.conctc.2024.101311","url":null,"abstract":"<div><p>The EISI study protocol aims to address the low participation rate in physical exercise programs among older individuals, emphasizing its significance as a non-pharmacological therapeutic approach for overall health and increased physical activity. The objectives include implementing physical activity (PA) and educational health programs in Jequié, Bahia, Brazil, targeting the Family Health Strategy population to enhance local physical activity levels among older individuals. The study also seeks to evaluate the program's feasibility, safety, and sustainability for large-scale implementation, along with assessing its impact on immune and inflammatory response biomarkers to the SARS-CoV virus, as well as physical-functional and brain health. Participants, aged 60 or above, will be divided into two groups: multicomponent exercise (MCE) and behavioral change interventions (BCI). The study employs a mixed-method approach, utilizing a non-randomized controlled short-term pathway model for a 4–8 weeks of pilot study and 16-week intervention impact assessment. Data collection encompasses various aspects such as sociodemographic information, mental health, physical fitness, fall risk, functional capacity, anthropometric measurements, hemodynamic assessment, habitual physical activity, and health-related quality of life. Blood and saliva samples are collected for cytokine and antibody biomarker analysis related to SARS-CoV immunity. Pre- and post-intervention evaluations for both groups will be conducted, with the hypothesis that MCE will yield more favorable responses compared to BCI. The study's holistic approach, including the assessment of feasibility, safety, and sustainability, aims to contribute to achieving Sustainable Development Goals (SDG) 3 and SDG 9 b y promoting accessible and sustainable healthcare initiatives for older individuals. This research aligns with global efforts to enhance health and well-being, emphasizing the importance of regular exercise in the aging population.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"39 ","pages":"Article 101311"},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000589/pdfft?md5=c660e05ba5e11776c7d74c38a8dd6795&pid=1-s2.0-S2451865424000589-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141142351","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 mechanism of Sangdantongluo granule in treating post-stroke spasticity based on multimodal fMRI combined with TMS: Study protocol","authors":"Jie Tang ,&nbsp;Yao Xie ,&nbsp;Rui Fang ,&nbsp;Huizhong Tan ,&nbsp;Shanshan Zeng ,&nbsp;Zan Wen ,&nbsp;Xiongxing Sun ,&nbsp;Ting Yao ,&nbsp;Shiliang Wang ,&nbsp;Le Xie ,&nbsp;Dahua Wu","doi":"10.1016/j.conctc.2024.101317","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101317","url":null,"abstract":"<div><h3>Introduction</h3><p>Post-stroke spasticity (PSS) is among the prevalent complications of stroke, greatly affecting motor function recovery and reducing patients' quality of life without timely treatment. Sangdantongluo granule, a modern traditional Chinese patent medicine, has significant clinical efficacy in treating PSS. However, the mechanism of Sangdantongluo granule in treating PSS is still unknown. We designed this study to explore the mechanism of Sangdantongluo granule in treating PSS through multimodal functional magnetic resonance imaging (fMRI) combined with transcranial magnetic stimulation (TMS).</p></div><div><h3>Methods and analysis</h3><p>In a single-center, randomized, double-blind, parallel placebo-controlled study, 60 PSS patients will be recruited in China and randomly assigned to either the experimental or control groups at a ratio of 1:1. For eight weeks, Sangdantongluo granule or placebo will be utilized for intervention. The main outcome is the Modified Ashworth Scale (MAS), the secondary outcome includes the Fugl-Meyer Assessment Scale-upper Extremity (FMA-UE), National Institute of Health Stroke Scale (NIHSS), and Modified Rankin Scale (mRS), the mechanism measure is the changes in cortical excitability and multimodal fMRI at baseline and after eight weeks.</p></div><div><h3>Ethics and dissemination</h3><p>This study was approved by the Ethics Committee of the Affiliated Hospital of Hunan Academy of Traditional Chinese Medicine (approval number: [202364]).</p></div><div><h3>Clinical trial registration</h3><p>Chinese Clinical Trial Registry, identifier: ChiCTR2300074793. Registered on 16 August 2023.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"39 ","pages":"Article 101317"},"PeriodicalIF":1.5,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000644/pdfft?md5=1e9e021fab917dfcc2f4fd055b1555a4&pid=1-s2.0-S2451865424000644-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141249726","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":"Redefining feasibility in clinical trials: Collaborative approaches for improved site selection","authors":"Beau Bruneau ,&nbsp;Kristin Surdam ,&nbsp;Amy Bland ,&nbsp;Amy Krueger ,&nbsp;Andrew Wise ,&nbsp;Ani Cotarlan ,&nbsp;Asher Leviton ,&nbsp;Elena Jouravleva ,&nbsp;Grace Fitzgerald ,&nbsp;Heather N. Frost ,&nbsp;Honora F. Cutler ,&nbsp;Joshua Buddle ,&nbsp;Luis G. Diaz ,&nbsp;Michele Cohen ,&nbsp;Nancy A. Sacco ,&nbsp;Ryan Washington ,&nbsp;Susan Mauermann ,&nbsp;Victor Chen ,&nbsp;Andrea Bastek","doi":"10.1016/j.conctc.2024.101291","DOIUrl":"https://doi.org/10.1016/j.conctc.2024.101291","url":null,"abstract":"<div><h3>Background</h3><p>This Site Feasibility Task Force convened to assess the complex and burdensome process of site feasibility in clinical trials. The objective was to create mutual understanding of challenges and provide suggestions for improving collaboration among sponsors, contract research organizations (CROs), and sites.</p></div><div><h3>Methods</h3><p>The task force was composed of representatives from sponsors, CROs and sites (43 % Sites, 20 % Site Networks, 10 % Small/mid-size sponsors, 10 % Small/mid-size CROs, 10 % Large sponsors, 7 % Large CROs). The group collaborated to define the scope of the problem, identify challenges in the current process, and provide suggestions for improving the process.</p></div><div><h3>Results</h3><p>The group found there is a need for better differentiation between the three main stages of feasibility, and the four sub-phases of Site Feasibility. The discussion brought to light emerging trends like early initiation of Site Feasibility and premature engagement of sites by CROs. To fully explain these challenges, the group analyzed the current practices and documented their downstream impact on clinical trial execution for all stakeholders. A list of best practices emerged naturally from this analysis. These findings are aggregated into short and actionable best practice guides.</p></div><div><h3>Conclusion</h3><p>The task force suggests practical changes for the feasibility process and raises awareness of emerging trends and their associated risks. This awareness can begin to drive change in the site feasibility process, although industry-wide transformation will require new levels of collaboration, data standardization and automation tools. The potential benefits of evolving this process are significant and meaningful for more efficient and successful clinical trials.</p></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"40 ","pages":"Article 101291"},"PeriodicalIF":1.4,"publicationDate":"2024-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2451865424000383/pdfft?md5=1a790ad586aa6b1ed7ed1bb2d0816420&pid=1-s2.0-S2451865424000383-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141607967","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}