Trials最新文献

{"title":"Assessing the efficacy and safety of STOP (successful treatment for paranoia)-an app-based cognitive bias modification therapy for paranoia: a randomised clinical trial protocol.","authors":"Jenny Yiend, Rayan Taher, Carolina Fialho, Chloe Hampshire, Che-Wei Hsu, Thomas Kabir, Jeroen Keppens, Philip McGuire, Elias Mouchlianitis, Emmanuelle Peters, Tanya Ricci, Sukhwinder Shergill, Daniel Stahl, George Vamvakas, Pamela Jacobsen","doi":"10.1186/s13063-024-08570-3","DOIUrl":"10.1186/s13063-024-08570-3","url":null,"abstract":"<p><strong>Background: </strong>Paranoia, the belief that you are at risk of significant physical or emotional harm from others, is a common difficulty, which causes significant distress and impairment to daily functioning, including in psychosis-spectrum disorders. According to cognitive models of psychosis, paranoia may be partly maintained by cognitive processes, including interpretation biases. Cognitive bias modification for paranoia (CBM-pa) is an intervention targeting the bias towards interpreting ambiguous social scenarios in a way that is personally threatening. This study aims to test the efficacy and safety of a mobile app version of CBM-pa, called STOP (successful treatment of paranoia).</p><p><strong>Methods: </strong>The STOP study is a double-blind, superiority, three-arm randomised controlled trial (RCT). People are eligible for the trial if they experience persistent, distressing paranoia, as assessed by the Positive and Negative Syndrome Scales, and show evidence of an interpretation bias towards threat on standardised assessments. Participants are randomised to either STOP (two groups: 6- or 12-session dose) or text-reading control (12 sessions). Treatment as usual will continue for all participants. Sessions are completed weekly and last around 40 min. STOP is completely self-administered with no therapist assistance. STOP involves reading ambiguous social scenarios, all of which could be interpreted in a paranoid way. In each scenario, participants are prompted to consider more helpful alternatives by completing a word and answering a question. Participants are assessed at baseline, after each session, and at 6, 12, 18 and 24 weeks post-randomisation. The primary outcome is the self-reported severity of paranoid symptoms at 24 weeks, measured using the Paranoia Scale. The target sample size is 273 which is powered to detect a 15% symptom reduction on the primary outcome. The secondary outcomes are standardized measures of depression, anxiety and recovery and measures of interpretation bias. Safety is a primary outcome and measured by the Negative Effects Questionnaire and a checklist of adverse events completed fortnightly with researchers. The trial is conducted with the help of a Lived Experience Advisory Panel.</p><p><strong>Discussion: </strong>This study will assess STOP's efficacy and safety. STOP has the potential to be an accessible intervention to complement other treatments for any conditions that involve significant paranoia.</p><p><strong>Trial registration: </strong>ISRCTN registry, ISRCTN17754650. Registered on 03/08/2021.  https://doi.org/10.1186/ISRCTN17754650 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"806"},"PeriodicalIF":2.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11610111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142772633","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of mesoglycan in the acute phase of hemorrhoidal disease (the CHORMES study): study protocol for a double-blind, randomized controlled trial.","authors":"Gaetano Gallo, Arcangelo Picciariello, Alberto Realis Luc, Antonella Salvatore, Angelo Di Vittori, Marcella Rinaldi, Mario Trompetto","doi":"10.1186/s13063-024-08648-y","DOIUrl":"10.1186/s13063-024-08648-y","url":null,"abstract":"<p><strong>Background: </strong>Hemorrhoidal disease (HD) is associated with substantial economic burden and negative effects on health-related quality of life (HRQoL). The aCute HaemORrhoids treatment with MESoglycan (CHORMES) study aims to evaluate the effects of orally administered mesoglycan, a natural preparation of glycosaminoglycans with antithrombotic and profibrinolytic properties, as an acute treatment in patients with HD.</p><p><strong>Methods: </strong>CHORMES is a phase 2, double-blind, randomized controlled trial being conducted at two centers in Italy. Adults aged 18-75 years with Grade I-III HD according to Goligher classification or external thrombosed hemorrhoids, and a Hemorrhoidal Disease Symptom Score (HDSS) of ≥ 5, will be randomly allocated in a 1:1 ratio to mesoglycan or placebo and will be treated for 40 days (two capsules for the first 5 days and one capsule for the subsequent 35 days twice daily [after breakfast and dinner], equivalent to 200 mg in the first 5 days and 100 mg subsequently). Concomitant use of analgesics is permitted in both treatment groups. The trial aims to enroll 50 patients, with 25 patients in each treatment group. The primary objective of the trial is to evaluate the efficacy of mesoglycan in reducing symptoms of HD, assessed via change in HDSS from baseline (day 0) to day 40 in the intention-to-treat population. Secondary objectives include changes in HRQoL from baseline to day 40 using the Short Health Scale for Hemorrhoidal Disease, safety (adverse effects, physical assessments, vital signs and laboratory parameters in the safety population), fecal continence assessed using the Vaizey score, bleeding assessed using the Bleeding score, the amount and type of analgesic taken, and pain. Patient enrolment began on 11 December 2023, and trial completion is expected by December 2024.</p><p><strong>Discussion: </strong>The CHORMES trial will evaluate the efficacy and safety of mesoglycan, in addition to its impact on HRQoL, analgesic use and pain, in patients with HD. The results of the trial will assist clinicians in determining the most effective treatment for patients with HD.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06101992. Prospectively registered on 26 October 2023 at https://clinicaltrials.gov/ct2/show/NCT06101992 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"807"},"PeriodicalIF":2.0,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613797/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142772648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Efficacy of the preformulated irrigation solution Bactisure® in acute periprosthetic joint infection debridement surgery: study protocol for a randomized controlled trial.","authors":"Rafael Oleo-Taltavull, Matías Vicente Gomà-Camps, Nayana Joshi Jubert, Pablo S Corona","doi":"10.1186/s13063-024-08663-z","DOIUrl":"https://doi.org/10.1186/s13063-024-08663-z","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"804"},"PeriodicalIF":2.0,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11608469/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142772635","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Agile monitoring dashboard for clinical research studies.","authors":"Leslie Gardner, Peggy Bylund, Sarah Robbins, Emma Holler, Fereshtehossadat Shojaei, Fatemehalsadat Shojaei, Mark Seidman, Richard J Holden, Nicole R Fowler, Ben Zarzaur, Cristina Barboi, Malaz Boustani","doi":"10.1186/s13063-024-08646-0","DOIUrl":"10.1186/s13063-024-08646-0","url":null,"abstract":"<p><strong>Background: </strong>Clinical trial success hinges on efficient participant recruitment and retention. However, slow accrual and attrition frequently hinder progress. To address these challenges, a novel dashboard tool with control charts has been developed to provide investigators on the multi-site study of Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE study) with timely information to improve trial recruitment.</p><p><strong>Methods: </strong>A quality monitoring Excel dashboard with control chart functionality developed by the principal investigator's (PI) group and implemented in a department of a large hospital was re-engineered for research study recruitment purposes. The dashboard provides the PIs and other stakeholders with timely, actionable, and unbiased information on the count of participants who have completed each stage or action within the process, the rates of completion and trends, both for the current week and cumulatively.</p><p><strong>Results: </strong>The DANE dashboard was prototyped using Microsoft Excel for accessibility and rapid development. The tool integrates with a REDCap database, simplifying data import and analysis. By facilitating informed decision-making throughout the recruitment process, the DANE dashboard has significantly enhanced clinical trial efficiency and led to changes in the eligibility criteria and improvements in the approach and consent processes.</p><p><strong>Conclusions: </strong>The DANE dashboard for monitoring participant recruitment and attrition in research studies represents a significant step towards enhancing study management and decision-making processes. It can be adapted to other clinical studies and other staged processes with attrition. The generic version, currently under development, holds promise for evolving into a valuable simulator by incorporating a spreadsheet for generating random data and accounting for resource constraints. This enhancement could further be augmented by integrating forecasting capabilities into the control charts.</p><p><strong>Trial registration: </strong>The Delirium and Neuropsychological Recovery among Emergency General Surgery Survivors (DANE) study (NCT05373017, 1R01AG076489-01) is a multi-site, two-arm, single-blinded randomized controlled clinical trial to evaluate the efficacy of the Emergency General Surgery (EGS) Delirium Recovery Model to improve the cognitive, physical, and psychological recovery of EGS delirium survivors over 65. The DANE study received approval from the University of Wisconsin-Madison/University of Wisconsin Hospitals and Clinics Institutional Review Board (IRB, no. 2022-0545, approval date September 14, 2022), and Indiana University agreed to cede IRB review to University of Wisconsin-Madison/University of Wisconsin Hospital and Clinics (September 29, 2022).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"802"},"PeriodicalIF":2.0,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11606209/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142751829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Optimising AVATAR therapy for people who hear distressing voices: study protocol for the AVATAR2 multi-centre randomised controlled trial.","authors":"Philippa Garety, Clementine J Edwards, Thomas Ward, Richard Emsley, Mark Huckvale, Paul McCrone, Mar Rus-Calafell, Miriam Fornells-Ambrojo, Andrew Gumley, Gillian Haddock, Sandra Bucci, Hamish McLeod, Amy Hardy, Emmanuelle Peters, Inez Myin-Germeys, Thomas Craig","doi":"10.1186/s13063-024-08549-0","DOIUrl":"10.1186/s13063-024-08549-0","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"803"},"PeriodicalIF":2.0,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11605860/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A study protocol for a multi-country cluster randomized controlled trial of the impact of a multi-component One Health strategy to eliminate Opisthorchis viverrini and soil transmitted helminths in the Lower Mekong Basin.","authors":"Mary Lorraine Mationg, Archie C A Clements, Gail M Williams, Matthew Kelly, Donald E Stewart, Catherine A Gordon, Kinley Wangdi, Sirikachorn Tangkawattana, Apiporn T Suwannatrai, Vanathom Savathdy, Visal Khieu, Sangduan Wannachart, Suji Yoo O'Connor, Simon Forsyth, Sean Gannon, Peter Odermatt, Donald P McManus, Somphou Sayasone, Virak Khieu, Banchob Sripa, Darren J Gray","doi":"10.1186/s13063-024-08616-6","DOIUrl":"10.1186/s13063-024-08616-6","url":null,"abstract":"<p><strong>Background: </strong>Opisthorchis viverrini (OV) and soil-transmitted helminths (STH) are two of the most common helminths contributing to the Neglected Tropical Disease (NTDs) burden in the Lower Mekong Basin. Although mass drug administration is the cornerstone of control programs to reduce morbidity caused by these infections, this approach has limitations in preventing re-infections. Elimination requires additional measures such as reservoir host treatment, improved hygiene and health education to reinforce MDA's impact. This study aims to examine the impact of a scalable multi-component One Health Helminth Elimination program in the Lower Mekong Basin (HELM) that combines human praziquantel (PZQ) and albendazole (ALB) treatment with a program that includes the \"Magic Glasses\" and the \"Lawa Model\" interventions with health promotion at their core.</p><p><strong>Methods: </strong>This study will employ a cluster randomized controlled trial (cRCT) in 18 rural communities (with sub-district or villages as cluster units) across Cambodia, Laos and Thailand. The control arm will receive one round of PZQ/ALB treatment, while in the intervention arm, multi-component HELM program will be implemented, which includes PZQ/ALB treatment together with the Magic Glasses and Lawa Model interventions. OV and STH infections levels will be evaluated in individuals aged 5-75 years at baseline and will be repeated at follow-up (12 months after the HELM intervention), using modified formalin ethyl-acetate concentration technique and quantitative PCR. The primary outcome of the study will be cumulative incidence of human OV and STH infections. Outcomes between the study arms will be compared using generalized linear mixed models, accounting for clustering.</p><p><strong>Discussion: </strong>Evidence from this trial will quantify the impact of a multi-component One Health control strategy in interrupting Ov and STH infections in the Lower Mekong Basin.</p><p><strong>Trial registration: </strong>Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12622000353796. Prospectively registered 28 February 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"801"},"PeriodicalIF":2.0,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603964/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142740638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparisons of efficacy and safety of 400 or 800 ml bacterial count fecal microbiota transplantation in the treatment of recurrent hepatic encephalopathy: a multicenter prospective randomized controlled trial in China.","authors":"Pengfei Zou, Yunjiao Bi, Zhaowei Tong, Tao Wu, Qiang Li, Kai Wang, Yuchen Fan, Dan Zhao, Xin Wang, Hui Shao, Haijun Huang, Suping Ma, Yunsong Qian, Guoqiang Zhang, Xiao Liu, Qiaofei Jin, Qingjing Ru, Zhiping Qian, Wei Sun, Qiang Chen, Liying You, Fang Wang, Xiaoting Zhang, ZhenXiong Qiu, Qing Lin, Jiaojian Lv, Yongping Zhang, Jiawei Geng, Richeng Mao, Jinfeng Liu, Yubao Zheng, Feng Ding, Hui Wang, Hainv Gao","doi":"10.1186/s13063-024-08578-9","DOIUrl":"10.1186/s13063-024-08578-9","url":null,"abstract":"<p><strong>Background: </strong>Hepatic encephalopathy (HE) represents a critical complications of end-stage liver disease, serving as an independent predictor of mortality among patients with cirrhosis. Despite effective treatment with rifaximin, some patients with HE still progress to recurrent episodes, posing a significant therapeutic challenge. Recurrent HE is defined as experiencing two or more episodes within a 6-month period. Previous research has suggested that FMT may emerge as a promising treatment for recurrent HE. However, there remains a critical need to explore the optimal dosage. This trial aims to abscess the efficacy and safety of two FMT dosages: 800 ml or 400 ml total bacterial count, including mortality and quality of life.</p><p><strong>Methods: </strong>This multicenter, prospective, randomized controlled trial will enroll 100 eligible patients from 31 hospitals in China. Participants will be randomly assigned in a 1:1 ratio to either the high-dose group (800 ml total bacterial count) or the low-dose group (400 ml total bacterial count). The primary objective is to assess the efficacy and safety of both dosages on outcomes at 24 and 48 weeks, including mortality and quality of life.</p><p><strong>Discussion: </strong>If either or both dosages of FMT demonstrate safe and effective treatment of recurrent HE, leading to improve quality of life and survival at 24 and 48 weeks, this trial would address a significant gap in the management of recurrent HE, carrying innovative and clinically significant implications.</p><p><strong>Trial registration: </strong>NCT05669651 on ClinicalTrials.gov. Registered on 29 December 2022. CHiCTR2200067135 on China Registered Clinical Trial Registration Center. Registered on 27 December 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"799"},"PeriodicalIF":2.0,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11600821/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142740641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation and evaluation of a navigation program for people with cancer in old age and their family caregivers: study protocol for the EU NAVIGATE International Pragmatic Randomized Controlled Trial.","authors":"Tinne Smets, Lara Pivodic, Rose Miranda, Fien Van Campe, Chelsea Vinckier, Barbara Pesut, Wendy Duggleby, Andrew N Davies, Amanda Lavan, Peter May, Barbara Gomes, Maja Furlan de Brito, Vitor Rodrigues, Katarzyna Szczerbińska, Violetta Kijowska, Ilona Barańska, Stefanie De Buyser, Davide Ferraris, Sara Alfieri, Bianca Scacciati, Helena Du Cheyne, Kenneth Chambaere, Joni Gilissen, Annicka G M van der Plas, Roeline H Pasman, Bregje D Onwuteaka-Philipsen, Lieve Van den Block","doi":"10.1186/s13063-024-08633-5","DOIUrl":"10.1186/s13063-024-08633-5","url":null,"abstract":"<p><strong>Background: </strong>Cancer navigation programs aim to support, educate, and empower patients and families, addressing barriers to diagnostics, treatment, and care. Navigators engage with people to ensure timely access to services and resources. While promising for older people with cancer, these programs are scarce in Europe, and research on their effectiveness and implementation is limited. We describe the protocol of the EU NAVIGATE randomized controlled trial, aimed to evaluate (1) effectiveness and cost-effectiveness of NavCare-EU, an intervention that aims to support older people with cancer throughout their illness trajectory, spanning the continuum of supportive, palliative, and end-of-life care, and (2) the intervention's implementation processes and feasibility of its integration into different health care systems in Europe, contextual barriers and facilitators for effective and sustainable implementation, and mechanisms involved in reaching the outcomes.</p><p><strong>Methods: </strong>We will conduct a multisite pragmatic fast-track randomized controlled trial with embedded convergent mixed-method process evaluation in Belgium, Ireland, Italy, Netherlands, Poland, and Portugal. The study targets people with cancer and declining health, 70 years or older, and their close family caregivers. The trial compares the NavCare-EU intervention plus standard care with standard care alone. We will perform a baseline measurement prior to randomization and follow-up measurements at 12 weeks, 24 weeks, and 48 weeks in intervention and control group, and an additional measurement at 72 weeks in the control group. Primary outcomes, measured at 24 weeks are (1) the older person's global health status/quality of life, a 2-item subscale from EORTC-QLQ-C30 (revised) measuring health-related quality of life, (2) level of social support measured with Medical Outcomes Study Social Support Survey (MOS-SSS scale). The study will include at least 246 older persons with completed global health status/quality of life at 24 weeks.</p><p><strong>Discussion: </strong>The EU NAVIGATE trial will cross-nationally test the effectiveness and cost-effectiveness of a navigation intervention for older people with cancer and their family caregivers, and its implementation in different health care systems in Europe. As continuity and access to health, social, and community care is a priority for patients and caregivers, the trial is timely and critically needed.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov: identifier NCT06110312 (2023/10/31).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"800"},"PeriodicalIF":2.0,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603903/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142740599","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High-concentrated platelet-rich plasma (PRP) versus placebo in osteoarthritis in the thumb base: study protocol for an assessor-blinded randomized controlled trial.","authors":"Johanna von Kieseritzky, Maria Wilcke","doi":"10.1186/s13063-024-08636-2","DOIUrl":"10.1186/s13063-024-08636-2","url":null,"abstract":"<p><strong>Background: </strong>Osteoarthritis in the thumb base (trapeziometacarpal joint, CMC-1 joint) is prevalent, particularly among middle-aged and elderly women, causing significant disability. Conservative treatments, including steroid injections, have been questioned for their efficacy, prompting exploration into alternative therapies such as platelet-rich plasma (PRP) injections. This randomized, double-blinded, controlled trial aims to evaluate the effectiveness of high-concentration PRP (platelet-rich plasma) injection compared to saline (placebo) in reducing pain and disability in patients with thumb base osteoarthritis.</p><p><strong>Methods: </strong>Patients meeting inclusion criteria will be randomized and blinded, with injections administered under sterile conditions and radiological guidance. With a planned sample size of 90 patients recruited from the Department of Hand Surgery at Södersjukhuset, Stockholm, the study will assess pain relief and functional improvement at 3, 6, and 12 months post-injection. The primary outcome measure is pain on load (numerical rating scale) at 6 months, with secondary outcomes including patient-reported outcomes, key pinch, grip strength, abduction of the thumb, and time to intervention within 1 year. Statistical analyses will employ non-parametric tests, chi-square tests, and generalized estimating equations to compare outcomes between the PRP and placebo groups.</p><p><strong>Discussion: </strong>The study aims to provide evidence regarding the efficacy of high-concentration PRP injections for thumb base osteoarthritis. If PRP proves superior to saline in reducing pain and improving function, it could offer a promising alternative treatment. Conversely, if PRP does not demonstrate significant benefits over placebo, its use for this condition is not justified. This study seeks to address the current gap in evidence regarding the efficacy of PRP injections for thumb base osteoarthritis.</p><p><strong>Trial registration: </strong>The study has been approved by the Swedish Ethical Review Authority (2023-06860-01 and 2024-01238-02) and is registered on ClinicalTrials.gov (NCT06193499) 2024-01-04.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"797"},"PeriodicalIF":2.0,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11590339/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142717298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of prebiotics on microbial diversity and abundance in young children with acute malnutrition: study protocol for a multi-centered, double-blinded randomized controlled trial.","authors":"Javeria Saleem, Rubeena Zakar, Sanaullah Iqbal, Muhammad Arshad, Ruhma Shahzad, Munazza Batool, Muhammad Nawaz, Muhammad Salman Butt, Florian Fischer","doi":"10.1186/s13063-024-08647-z","DOIUrl":"10.1186/s13063-024-08647-z","url":null,"abstract":"<p><strong>Background: </strong>The anti-inflammatory and antimicrobial benefits of prebiotics may present an affordable and cost-effective strategy for not only the prevention but also treatment of malnutrition. Therefore, the present trial has been designed with the aim to evaluate the role of prebiotics on the gut microbiome of severe acute malnourished (SAM) children.</p><p><strong>Methods: </strong>The study is designed as a prospective, double-blinded, triple-armed, multi-centered randomized controlled trial, with 6-59 months old uncomplicated SAM children recruited to the experimental group receiving ready-to-use therapeutic food (RUTF) plus prebiotics and the active comparator group receiving RUTF plus starch for 2 months duration (8 weeks). Healthy children with matching age and gender will be recruited to placebo comparator group and will receive starch as a placebo during the study period. A total of 58 participants will be recruited to each arm with 1:1:1 allocation ratio following a pre-defined inclusion and exclusion criteria. The results of the gut microbiome diversity will serve as the primary outcome, while weight-for-height/length z-score, mid-upper-arm circumference, neurodevelopment assessment, and body mass accumulation will serve as the secondary outcome. Data collection and evaluations will be conducted at baseline and at the end of the trial (week 8), while the safety monitoring will be conducted at every second week. For analysis, the principles of intention-to-treat will be followed.</p><p><strong>Conclusions: </strong>Conclusively, the results of the present trial would provide useful insights and high-quality data for the treatment and management of SAM children by evaluating the effect of RUTF plus prebiotic on the gut microbiome diversity of children, leading to medical evidence for designing the large-scale studies.</p><p><strong>Trial registration: </strong>The present trial is registered at ClinicalTrials.gov with identifier No: NCT06155474 and registration date 4 December 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"25 1","pages":"798"},"PeriodicalIF":2.0,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11590257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142732463","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}