Contemporary Clinical Trials Communications最新文献

{"title":"Effect of dry needling on quadriceps muscles fatigue in taekwondo players: A protocol for a triple-blinded randomized controlled trial","authors":"Reyhaneh Aghajani ,&nbsp;Elaheh Dehghani ,&nbsp;Mohammad Saeid Khonji ,&nbsp;Soofia Naghdi ,&nbsp;Noureddin Nakhostin Ansari ,&nbsp;Jan Dommerholt ,&nbsp;Amin Nakhostin-Ansari","doi":"10.1016/j.conctc.2025.101476","DOIUrl":"10.1016/j.conctc.2025.101476","url":null,"abstract":"<div><h3>Background</h3><div>A common issue among athletes is muscle fatigue, a brief and transient reduction in the potential of skeletal muscle strength after engaging in muscular activity. A high-quality clinical investigation to evaluate the impact of dry needling (DN) on athletes’ muscle fatigue is lacking. Therefore, this study aims to examine the effect of DN on quadriceps muscle fatigue in taekwondo players.</div></div><div><h3>Methods</h3><div>A triple-blind, randomized, controlled trial will be conducted to measure changes in quadriceps muscle fatigue after DN. Eighty-eight taekwondo players who meet the eligibility criteria will be selected to receive either DN or sham needling to the quadriceps muscle after exercise. Three assessments will be performed before the exercise, after exercise fatigue, and after intervention. The outcomes measured will be isometric peak torque, single-leg hop test, and vertical jump test.</div></div><div><h3>Conclusions</h3><div>The results of this study will provide preliminary evidence regarding the effectiveness of DN in improving quadriceps muscle fatigue in taekwondo players.</div></div><div><h3>Trial registration</h3><div>IRCT20210811052141N1.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101476"},"PeriodicalIF":1.4,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143737804","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":"Experience of linking to the NHS diabetic eye screening programme records in the ASCEND-eye randomized trial and recommendations for improvement","authors":"Emily Sammons ,&nbsp;Louise Bowman ,&nbsp;Marion Mafham ,&nbsp;Jane Armitage","doi":"10.1016/j.conctc.2025.101474","DOIUrl":"10.1016/j.conctc.2025.101474","url":null,"abstract":"<div><h3>Background</h3><div>The ASCEND-Eye sub-study of the large, double-blind, 2x2 factorial design, placebo-controlled ASCEND trial compared the effects of aspirin and, separately, omega-3 fatty acids on diabetic retinopathy outcomes derived from NHS Diabetic Eye Screening Programmes (DESP) in England and Wales, in adults aged 40 years or older with diabetes and no pre-existing atherosclerotic cardiovascular disease. ASCEND-Eye was unprecedented in what it set out to achieve; no previous studies had successfully obtained linked DESP data for research purposes on a national scale in England and Wales before.</div></div><div><h3>Objective</h3><div>To describe our experience of linking DESP records to help other researchers wishing to use them. We explain the application process, lead times and resources required, and how these data were governed.</div></div><div><h3>Results</h3><div>The process of gaining regulatory and ethics committee approval for ASCEND-Eye through to data acquisition took four years. Several challenges were encountered, including a lack of documentation defining the governance of the NHS screening service, the absence of a single central data repository, the inherent complexity of liaising with multiple data controllers, and a lack of responsiveness to invitations to collaborate by nearly half of the DESPs in England.</div></div><div><h3>Conclusion</h3><div>Routinely collected healthcare data is a valuable source of outcome measure information in clinical trials. However, researchers frequently face barriers to accessing these datasets despite having written informed consent from trial participants to do so. We hope to encourage more NHS DESPs to take part in research.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101474"},"PeriodicalIF":1.4,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143746326","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":"An exploratory, open-label, parallel group, randomised controlled trial evaluating the effect of gene based nutritional intervention in type 2 diabetes: The protocol for NUDGE clinical trial","authors":"Savitesh Kushwaha ,&nbsp;Poonam Khanna ,&nbsp;Sanjay Kumar Bhadada ,&nbsp;Vivek Sagar ,&nbsp;Pramod Kumar Gupta ,&nbsp;Jarnail Singh Thakur ,&nbsp;Madhu Gupta ,&nbsp;Rachana Srivastava","doi":"10.1016/j.conctc.2025.101470","DOIUrl":"10.1016/j.conctc.2025.101470","url":null,"abstract":"<div><h3>Introduction</h3><div>Type 2 diabetes mellitus (T2DM) presents significant public health challenges in India, where unique genetic and phenotypic characteristics elevate susceptibility. Recent research highlights the interaction of genetic polymorphisms and dietary factors in T2DM management, forming the basis of personalised nutrition interventions. This study outlines the protocol for NUDGE clinical trial to evaluate the efficacy of gene-based dietary strategies compared to standard recommendations in T2DM management.</div></div><div><h3>Methods</h3><div>The NUDGE trial is an exploratory, open-label, parallel-group, randomised controlled clinical trial conducted across healthcare settings in Chandigarh, India. A total of 300 participants diagnosed with T2DM will be randomised into intervention and control groups. The intervention group will receive personalised diet plans based on genetic polymorphisms (<em>TCF7L2</em> and <em>PPARG</em>), anthropometric, and lifestyle data, while the control group follows standard dietary advice. Baseline and endline assessments will measure fasting blood glucose, HbA1c, anthropometric parameters, and adherence.</div></div><div><h3>Discussion</h3><div>Primary outcomes focus on changes in FBG, while secondary outcomes include weight and blood pressure. Statistical analyses will evaluate gene-diet interactions and adherence to dietary plans. The trial aims to establish evidence for precision nutrition in T2DM by leveraging gene-diet interactions to tailor interventions. Findings will provide insights into the role of personalised nutrition in improving glycemic control.</div></div><div><h3>Conclusion</h3><div>The NUDGE trial seeks to advance precision nutrition in T2DM management, paving the way for individualised dietary recommendations to mitigate disease progression and complications.</div></div><div><h3>Ctri reg no</h3><div>CTRI/2021/09/036121 Clinical Trial Registry of India.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101470"},"PeriodicalIF":1.4,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143684415","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":"Beta-testing the feasibility of a family-based financial incentives smoking cessation intervention with Alaska Native families: Phase 2 of the Aniqsaaq (to breathe) Study","authors":"Brianna N. Tranby ,&nbsp;Antonia M. Young ,&nbsp;Anne I. Roche ,&nbsp;Flora R. Lee ,&nbsp;Ashley R. Brown ,&nbsp;Barb J. Stillwater ,&nbsp;Judith J. Prochaska ,&nbsp;Diane K. King ,&nbsp;Paul A. Decker ,&nbsp;Bijan J. Borah ,&nbsp;Michael G. McDonell ,&nbsp;Timothy K. Thomas ,&nbsp;Christi A. Patten","doi":"10.1016/j.conctc.2025.101472","DOIUrl":"10.1016/j.conctc.2025.101472","url":null,"abstract":"<div><h3>Background</h3><div>Alaska Native and American Indian (ANAI) communities in Alaska have disproportionately high commercial tobacco smoking rates and face barriers to accessing cessation treatment. We beta-tested the feasibility of a remotely delivered, ANAI family-based financial incentive cessation intervention.</div></div><div><h3>Methods</h3><div>We enrolled 10 “dyads” (i.e., one adult ANAI person who smokes [PWS] and one adult family member of their choice) across Alaska into a culturally tailored 6-month intervention (NCT05209451). PWS completed expired carbon monoxide, salivary cotinine, and self-reported abstinence measures at home during six smoking status check-ins. Both dyad members received financial incentives in escalating amounts for confirmed PWS abstinence. Participants completed baseline and end-of-study surveys.</div></div><div><h3>Results</h3><div>Eight of the 10 PWS were women, their average age was 45 years (range = 34–57), and mean daily cigarettes smoked was 13 (range = 3–20). Five of the 10 family members were women, and four currently also smoked. Of the 60 check-ins possible among PWS participants, 41 (68 %) were completed; five (50 %) completed all check-ins. Despite minor difficulties with PWS internet connection, lost test kits, and delayed payment receipt, all participants were able to complete check-ins and received payments earned. Five PWS were abstinent at the final 6-month check-in, and two PWS were abstinent at all check-ins. Five PWS completed the end-of-study survey; four reported the intervention was helpful and would recommend it to others.</div></div><div><h3>Conclusion</h3><div>A family-based financial incentive intervention for smoking cessation with ANAI families appears feasible. Next, a randomized controlled trial will be conducted statewide to evaluate effectiveness and inform future implementation needs.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101472"},"PeriodicalIF":1.4,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143703928","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":"Impact of a digital platform and flare risk blood biomarker index on lupus: A study protocol design for evaluating self efficacy and disease management","authors":"Eldon R. Jupe ,&nbsp;Mohan Purushothaman ,&nbsp;Bruce Wang ,&nbsp;Gerald Lushington ,&nbsp;Sandeep Nair ,&nbsp;Vijay R. Nadipelli ,&nbsp;Bernard Rubin ,&nbsp;Melissa E. Munroe ,&nbsp;Jessica Crawley ,&nbsp;Sneha Nair ,&nbsp;Georg Armstrong ,&nbsp;Arif Sorathia ,&nbsp;Brett Adelman","doi":"10.1016/j.conctc.2025.101471","DOIUrl":"10.1016/j.conctc.2025.101471","url":null,"abstract":"<div><div>We report the design of a pilot study employing clinic visits and a synergized digital, health coaching, and biomarker platform (aiSLE® MGMT [Management]) aimed at improving patient self-efficacy and patient-physician interactions to mitigate heightened disease activity, curtail clinical flares, and reduce potential long-term organ damage in systemic lupus erythematosus (SLE). This 12-month study will utilize a longitudinal cross-over design. Adult participants with confirmed SLE will be recruited and appropriately consented at five community-based US rheumatology clinics. Board certified rheumatologists will perform an exam, documenting the SLE Physician Global assessment (PGA) at Baseline, 3-, 6- and 9-month visits. Blood samples will be collected for completion of a newly developed and validated Lupus Flare Risk Index (L-FRI) that predicts the risk of developing a clinical flare in the next 12 weeks. The digital component of the study will be initiated following the 3-month visit. Participants will be given a mobile study app interfaced with a smartwatch to record activity, heart rate, and sleep quality. The app will be used to administer patient-reported outcome (PRO) surveys and health coaching. In the first three months participants and their rheumatologists will be blinded to L-FRI results; all L-FRI and digital results will be available starting in month four. This prospective pilot study will assess the impact of a comprehensive disease management platform employing a novel blood biomarker test, a mobile app interfaced with a smartwatch to collect biometric data, and app-based video health coaching on self-efficacy, clinical decisions, and outcomes in SLE disease management.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101471"},"PeriodicalIF":1.4,"publicationDate":"2025-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143684416","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":"Reducing inequalities through greater diversity in clinical trials – As important for medical devices as for drugs and therapeutics","authors":"Laurence S.J. Roope ,&nbsp;Jessica Walsh ,&nbsp;Maddie Welland ,&nbsp;Gabrielle Samuel ,&nbsp;Heidi Johansen-Berg ,&nbsp;Anna C. Nobre ,&nbsp;Stuart Clare ,&nbsp;Helen Higham ,&nbsp;Jon Campbell ,&nbsp;Tim Denison ,&nbsp;Karla L. Miller ,&nbsp;Seena Fazel ,&nbsp;Matthew L. Costa ,&nbsp;Andrew Farmer ,&nbsp;Marian Knight ,&nbsp;Rachel Taylor ,&nbsp;Lorna R. Henderson ,&nbsp;Angeli Vaid ,&nbsp;John Geddes ,&nbsp;Vasiliki Kiparoglou ,&nbsp;Philip M. Clarke","doi":"10.1016/j.conctc.2025.101467","DOIUrl":"10.1016/j.conctc.2025.101467","url":null,"abstract":"<div><div>In medicine and public health, the randomised controlled trial (RCT) is generally considered the key generator of ‘gold standard’ evidence. However, basic and clinical research and trials are often unrepresentative of real-world populations. Recruiting insufficiently diverse cohorts of participants in trials (e.g. in terms of socioeconomic status, racial and ethnic background, or sex and gender) may not only overstate the general effectiveness of a technology; it may also actively increase health inequalities. We highlight some general issues in this domain, before discussing several specific illustrative examples in the context of medical devices. High quality evidence on factors that would improve trial recruitment is extremely limited. There is a clear need for research on candidate strategies for improving recruitment of under-represented groups in RCTs. These could include, for example, offering various forms of financial incentives; non-monetary incentives, such as preferential access to the technologies that are being tested if they are found to be effective; and various types of informational messages and nudges; as well as involvement of community partners and champions in the recruitment process. Ideally, recruitment practices should ultimately be based on evidence generated from RCTs. Studies Within a Trial (SWAT), where randomised experiments are built into the actual recruitment processes in RCTs, are an ideal way to gain this evidence. SWAT studies are seeing an increase in traction, as indicated by funding streams in bodies such as the UK-based NIHR. Making greater funding available for studies of this kind is needed to improve the evidence base on how best to improve diversity in trial recruitment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101467"},"PeriodicalIF":1.4,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143746331","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 impact of a partnership care model on self-efficacy and self-care in hemodialysis patients: A quasi-experimental study","authors":"Khodayar Oshvandi ,&nbsp;Hossein Moradi ,&nbsp;Salman Khazaei ,&nbsp;Azim Azizi","doi":"10.1016/j.conctc.2025.101459","DOIUrl":"10.1016/j.conctc.2025.101459","url":null,"abstract":"<div><h3>Introduction and objective</h3><div>Self-care and self-efficacy are crucial in managing kidney failure requiring hemodialysis. However, traditional education methods have not effectively improved self-care and self-efficacy. Therefore, utilizing more effective models, such as the partnership care model, is essential. This study aimed to determine the impact of the partnership care model on self-care and self-efficacy in hemodialysis patients.</div></div><div><h3>Materials and methods</h3><div>This quasi-experimental study was conducted with 74 hemodialysis patients at Shahid Beheshti Hospital in Hamadan. Patients were divided into control and intervention groups. The control group received only routine care, while the intervention group received nursing care based on the partnership care model in addition to routine care. This included eight educational sessions over one month, with two sessions per week. Data were collected using self-care and Sherer self-efficacy questionnaires before and two months after the intervention. Data were analyzed using SPSS version 16.</div></div><div><h3>Results</h3><div>The study demonstrated significant improvements in self-care and self-efficacy among hemodialysis patients following the collaborative care intervention. Post-intervention, the experimental group showed substantial benefits with an effect size of 1.41 for self-care (95 % CI: 0.87–1.95, p &lt; 0.001) and an effect size of 1.55 for self-efficacy (95 % CI: 0.99–2.10, p &lt; 0.001), highlighting the effectiveness of the intervention.</div></div><div><h3>Conclusion</h3><div>The study demonstrated that the partnership care model, through comprehensive education and social and motivational support, significantly improved self-care and self-efficacy in hemodialysis patients. Therefore, it is recommended that hospitals and nurses adopt this model to enhance the health and quality of life of patients.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101459"},"PeriodicalIF":1.4,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143591623","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":"TRANSMIT: Utilizing discarded livers from donors with a history of cancer for patients lacking access to standard allocation - A compassionate use exploratory study","authors":"Dominik Thomas Koch ,&nbsp;Malte Schirren ,&nbsp;Severin Jacobi ,&nbsp;Christian Lange ,&nbsp;Jens Werner ,&nbsp;Dionysios Koliogiannis ,&nbsp;Markus Guba","doi":"10.1016/j.conctc.2025.101465","DOIUrl":"10.1016/j.conctc.2025.101465","url":null,"abstract":"<div><h3>Background</h3><div>A substantial number of viable donor livers are discarded due to the donor's underlying malignancy. Concurrently, patients with certain liver malignancies – such as unresectable colorectal cancer liver metastases (CRC-LM), unresectable intrahepatic or perihilar cholangiocarcinoma (iCCC/phCCC), or unresectable hepatocellular carcinoma (HCC) responding to immunotherapy – often face poor survival outcomes and are deemed ineligible for potentially curative liver transplantation. In this context, a rational risk-benefit analysis suggests that transplanting an organ with a theoretical risk of tumor transmission may be justifiable for these patients facing otherwise short-term fatal outcomes.</div></div><div><h3>Methods</h3><div>The TRANSMIT study is a compassionate use exploratory study aimed at assessing the utility and safety of using donor organs from individuals with a current or past history of cancer for liver transplantation in patients with liver malignancies (CRC-LM, i/phCCC, HCC) who are not eligible for regular organ allocation. The study will evaluate the utilization rate of donor organs that would otherwise be discarded, overall survival, progression-free survival, and tumor transmission rates at one and three years, stratified by indication.</div></div><div><h3>Discussion</h3><div>Donor organs from individuals with a current or past history of cancer may represent a valuable and safe resource for expanding the limited donor pool, particularly for patients who lack access to standard organ allocation.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101465"},"PeriodicalIF":1.4,"publicationDate":"2025-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143548489","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":"Curcumin supplementation combined with high intensity interval training modulates serum irisin and lipid profile in obese women: \"A randomized double-blind clinical trial\"","authors":"Bahram Jamali Gharakhanlou ,&nbsp;Solmaz Babaei Bonab ,&nbsp;Akram Amaghani ,&nbsp;Mohammad Reza Shiri-Shahsavar","doi":"10.1016/j.conctc.2025.101464","DOIUrl":"10.1016/j.conctc.2025.101464","url":null,"abstract":"<div><h3>Background</h3><div>Curcumin is the most widely known active substance of turmeric extract, which attributed numerous functional properties, including anti-inflammatory and cardioprotective properties. Inactivity and changes in lifestyle and subsequent overweight/obesity are becoming major health risk factors.</div></div><div><h3>Objective</h3><div>the aim of this study was to determine the effect of curcumin supplementation combined with high intensity interval trainings (HIIT) exercise on serum irisin and lipid profile in obese women.</div></div><div><h3>Methods</h3><div>40 inactive women (aged 30–35 years, and body mass index 30 and above) allocated in four groups (10 in each) as followed; curcumin (C), exercise plus curcumin (EC), placebo (P), and exercise plus placebo (EP). All subjects completed an eight-week HIIT program. The C and EC groups received one capsule containing 80 mg curcumin nanomicelle daily throughout study. Blood samples were taken in the beginning and after eight weeks to measure changes in the study variables (irisin and lipid profile). The ANCOVA and Bonferroni's post hoc test was used to compare variables between 4 groups and pairwise at a significance level of ≤0.05 using SPSS-22.</div></div><div><h3>Results</h3><div>The results revealed that mean serum irisin (p = 0.023), cholesterol (p = 0.019), triglyceride (p = 0.022), high-density lipoprotein (p = 0.009) and low-density lipoprotein (p = 0.011) were significantly changed in all intervention groups compared to the placebo group.</div></div><div><h3>Conclusion</h3><div>Based on these results, it can be concluded that HIIT training with curcumin consumption has a greater significancy on obesity reduction in women; Therefore, curcumin and HIIT exercise can be considered as a therapeutic approach to reduce the negative outcomes of obesity.</div></div><div><h3>Clinical trial registry number</h3><div>IRCT20141004019397N2, link.</div></div><div><h3>Statement of significance</h3><div>This study investigated the effects of curcumin supplementation combined with high-intensity interval training (HIIT) on human serum Irisin levels for the first time, in a clinical randomized trial. This suggests that HIIT training alongside curcumin consumption may be a promising therapeutic approach to reduce the negative health consequences of obesity in women.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101464"},"PeriodicalIF":1.4,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143488308","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":"Investigation of the improvement of swallowing function with low-frequency pulse waves or interference waves delivered via cervical electrical stimulation in patients with Parkinson's disease: A randomized controlled study protocol","authors":"Masahiro Nakamori ,&nbsp;Ryotaro Matsuyama ,&nbsp;Megumi Toko ,&nbsp;Hidetada Yamada ,&nbsp;Yuki Hayashi ,&nbsp;Kohei Yoshikawa ,&nbsp;Mineka Yoshikawa ,&nbsp;Toshikazu Nagasaki ,&nbsp;Yoshitaka Shimizu ,&nbsp;Hirofumi Maruyama","doi":"10.1016/j.conctc.2025.101463","DOIUrl":"10.1016/j.conctc.2025.101463","url":null,"abstract":"<div><div>Parkinson's disease (PD) is associated with a high rate of swallowing dysfunction, which may lead to aspiration pneumonia. This randomized controlled trial aims to investigate the effects of cervical electrical stimulation interventions (interferential current or low-frequency pulse wave stimulation) on swallowing dysfunction in patients with PD. The study will include patients with PD with Hoehn–Yahr stages 2–4 and will assess the swallowing function in a multifaceted manner using tools such as the 1 % citric acid cough test, videofluoroscopic swallowing study (VFSS), Functional Oral Intake Scale score, and Eating Assessment Tool-10 score. The primary endpoint is an improvement in the cough reflex, as measured by the citric acid cough test, whereas the secondary endpoints include changes in the swallowing function, including the VFSS, tongue pressure, and salivary substance P levels. Participants will receive 30 min of cervical stimulation daily for 2 weeks. This study also explores the use of novel instruments such as multichannel surface electromyography and electronic stethoscopes for the detailed assessment of swallowing physiology. By investigating these two electrical stimulation techniques, this study seeks to provide insights into the pathophysiology of swallowing dysfunction in PD and to evaluate the efficacy and safety of these interventions.</div></div><div><h3>Trial registration number</h3><div>jRCTs062240041; pre-results.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"44 ","pages":"Article 101463"},"PeriodicalIF":1.4,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143510231","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}