Multicentre, randomised waitlist control trial investigating a parent-assisted social skills group programme for adolescents with brain injuries: protocol for the friends project by Rose Gilmore, Leanne Sakzewski, Jenny Ziviani, Sarah Mcintyre, Hayley Smithers Sheedy, Nicola Hilton, Tracey Williams, Kirsten Quinn, Anne Marie Sarandrea, Elizabeth Laugeson, Mark Chatfield

“…To date, there has been limited research into the efficacy of social competence interventions in this population. Research from the Program for the Education and Enrichment of Relational Skills (PEERS) has demonstrated significant improvements in social competence skills, maintained at 1-year to 5-year follow-up, for adolescents with autism spectrum disorder. …”
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Effect of adjunctive intraoral balance appliance in the usual care of patients with chronic temporomandibular joint disorders using Korean medicine in South Korea: study protocol f... by Jae-Heung Cho, Hyungsuk Kim, Woo-Chul Shin, Se yun Kim, Whisung Cho, Jaehyun Park, Won-Seok Chung, Mi-yeon Song

“…Epidemiological studies have estimated that up to 75% of the population in the USA exhibits at least one sign of TMD. …”
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Rationale and Design of the REPEAT Trial: A Multicenter Randomized Trial Comparing Redo Surgical Aortic Valve Replacement to Valve‐in‐Valve Transcatheter Aortic Valve Replacement... by Matthias Raschpichler, Suzanne de Waha, Stefan Blankenberg, Marcio A. Diniz, Emilia Bagiella, Annetine C. Gelijns, Vinicius F. Calsavara, Aakriti Gupta, Niklas Schofer, Tsuyoshi Kaneko, Mohamed Abdel‐Wahab, Holger Thiele, Raj Makkar, Michael A. Borger

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Multicentre randomised double-blind placebo controlled trial of combination vancomycin and cefazolin surgical antibiotic prophylaxis: the Australian surgical antibiotic prophylaxis... by Allen C Cheng, Catherine McDougall, Allen Cheng, An Tran-Duy, Janine Roney, Kirsty Buising, Peter Choong, Michelle Dowsey, Trisha Peel, Sarah Astbury, David Paterson, Richard S de Steiger, Ross Crawford, Richard de Steiger, Philip Clarke, Peter Rehfisch Ben Howden, Robert Molnar, Sam Adie, Glenn Boyce, Jonathon Mulford, Michael Solomon, Tiffany Harris-Brown, Anton Peleg, Jessica Wisniewski, Stephanie Pereira, Zweena Badoordeen

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Improving the adoption of a school-based nutrition program: findings from a collaborative network of randomised trials by Courtney Barnes, Rachel Sutherland, Lisa Janssen, Jannah Jones, Katie Robertson, Justine Gowland-Ella, Nicola Kerr, Aimee Mitchell, Karen Gillham, Alison L. Brown, Luke Wolfenden

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Efficiency and effectiveness of intensive multidisciplinary follow-up of patients with stroke/TIA or myocardial infarction compared to usual monitoring: protocol of a pragmatic ran... by Yannick Béjot, Marc Bardou, Mathieu Boulin, Yves Cottin, Maurice Giroud, Anne-Laure Soilly, Gauthier Duloquin, Thibaut Pommier, Gabriel Laurent, Lucie Vadot, Héloïse Adam

“…Introduction The ongoing ageing population is associated with an increase in the number of patients suffering a stroke, transient ischaemic attack (TIA) or myocardial infarction (MI). …”
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Optimal Treatment of Magnetic Seizure Therapy (MST) in Patients with Clozapine-Resistant Schizophrenia (CRS) by Xiang Q, Xu P, Zhai Z, Jia Y, Li C, Liu D

“…As a promising alternative to MECT, MST requires further research in larger clinical population.Keywords: clozapine resistant schizophrenia, CRS, modified electroconvulsive therapy, MECT, magnetic seizure therapy, MST, clinical efficacy, neurocognition…”
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Web-Based Human Papillomavirus Education and Professional Skills Intervention for Health Care Providers: Protocol for a Randomized Controlled Trial by Jacob Martinez, Jacquelin I Cordero, Meagan Whitney, Katie L LaRoche, Gabriel Frietze, Eva M Moya, Kristin Gosselink

“…Tailored web-based educational programs for health care professionals, designed to address regional and patient population characteristics, may be a promising approach to enhancing the real-world implementation of clinical practice guidelines. …”
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Transition from child to adult health services for young people with cerebral palsy in Ireland; implications from a mixed-methods study [version 2; peer review: 2 approved] by Owen Hensey, Amanda Breen, Aisling Walsh, Mary Owens, Claire Kerr, Sebastian Koppe, Grace Lavelle, Meriel Norris, Michael Walsh, Jennifer M. Ryan, Thilo Kroll, Jennifer Fortune

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Randomised controlled trial comparing low doses of aspirin in the prevention of pre-eclampsia (ASAPP): a study protocol by Phyllis August, Paul Christos, Amrin Khander, Kathy Matthews, Charlene Thomas, Tanvir Alam, Claire Alcus, Leah Bush, Emmaneul Edusei, Line Malha

“…Low dose aspirin (ASA) is currently the only prophylactic therapy known to decrease PEC in this patient population. However, currently, there is no prospective literature comparing various low-dose ASA formulations in the risk reduction of PEC. …”
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Evaluation of a personalised adherence intervention to improve photoprotection in adults with Xeroderma Pigmentosum (XP): protocol for the trial of XPAND by John Weinman, Sam Norton, Jessica Walburn, Robert Sarkany, Vera Araujo-Soares, Paul McCrone, Kirby Sainsbury, Martha Canfield, Lesley Foster, Jakob Heydenreich, Adrian Mander, Falko F Sniehotta, Hans Christian Wulf

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“Youth 2.0 project”: Multi-professional Intervention to Protect Adolescents from NPS and Other Drug Use by V. Rapaccini, S. Biscontini, A. Molinaro, G.P. Di Loreto, A. Pasini, O. Corazza, A. Metastasio

“…Whereas heroin and cocaine were the most widespread substances, NPS, expecially cannabinoids, remained the preferred drug of choice in the population under 20 years of age. For what concern Youth 2.0 project, we noticed a significant decrease in cannabinoids use among adolescents in charge at the Usl Umbria 2 Addiction Department (from 3.9% in 2019 to 2.9% in 2022) with a parallel exponential growth (from 1.3% in 2019 to 5.2% in 2022) in adolescents monitored with Youth 2.0 Project. …”
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Bayesian Analysis of Time-To-Event Data in a Cluster-Randomized Trial: Major Outcomes With Personalized Dialysate TEMPerature (MyTEMP) Trial by Yongdong Ouyang, Bin Luo, Stephanie N. Dixon, Ahmed A. Al-Jaishi, P.J. Devereaux, Michael Walsh, Ron Wald, Merrick Zwarenstein, Sierra Anderson, Amit X. Garg

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Gubi Decoction Ameliorates Porous Cartilage Endplate in an Intervertebral Disc Degeneration Model Mouse Through Inhibition of NF-κB Activity and Pyroptosis by Yao S, Li Y, Ruan H, Wu L, Zeng H

“…After 8 weeks of LSI modeling, the therapeutic efficacy on IVDD was evaluated through changes in lumbar spine function, histopathological morphology, extracellular matrix (ECM) metabolism, nucleus pulposus (NP) cell viability, and cartilage endplate (CEP) cell pyroptosis; at 4 weeks after modeling, the activation of NF-κB signaling was detected.Results: GBD can attenuate the progression of IVDD in mice, resulting in substantially increases disc height index (DHI) and NP matrix, reduced the degree of annulus fibrosus (AF) tear and the formation of cavity in CEP. In parallel, GBD significantly improved the matrix metabolism-related indexes of IVD at 8 weeks after modeling. …”
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The VIP trial: a randomised controlled trial of the clinical effectiveness of a Victim Improvement Package (VIP) for the reduction of continued symptoms of depression or anxiety in... by Victoria Vickerstaff, Vari M Drennan, Marta Buszewicz, Anthony Kessel, Gerard Leavey, Jonathan Cooke, Chris Brewin, Teresa Lee, Marc Serfaty, Jessica Satchell, Gloria Laycock

“…Background Older crime victims may be particularly vulnerable to psychological distress.Objectives To compare the clinical effectiveness of a Victim Improvement Package (VIP) to treatment as usual (TAU) for reducing continued crime-associated distress.Design A three-step parallel-group single-blind randomised controlled trial.Setting Police-reported victims of community crime aged 65 and over were recruited from 12 local authority areas in a major urban city in England, UK.Participants Selection criteria—inclusion: victims of community crime aged 65 years or more, with significant Generalised Anxiety Disorder (GAD-2) and Patient Health Questionnaire (PHQ-2) distress associated with the crime. …”
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Rehabilitation after bone marrow transplant compared with usual care to improve patient outcomes (REBOOT): protocol for a randomised controlled trial by Linda Denehy, Shaza Abo, Christopher Swain, Camille E. Short, Nicole Kiss, Amit Khot, Eric Wong, Duncan Purtill, Clare O’Donnell, Marlena Klaic, Catherine L. Granger, Michelle Tew, Tim Spelman, Vinicius Cavalheri, Lara Edbrooke, on behalf on the REBOOT research team

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Effect of fecal microbiota transplantation on patients with sporadic amyotrophic lateral sclerosis: a randomized, double-blind, placebo-controlled trial by Renyi Feng, Qingyong Zhu, Ao Wang, Hanzhen Wang, Jiuqi Wang, Pei Chen, Rui Zhang, Dongxiao Liang, Junfang Teng, Mingming Ma, Xuebing Ding, Xuejing Wang

“…Methods Conducted as a double-blind, placebo-controlled, parallel-group, randomized clinical trial, the study enrolled 27 participants from October 2022 to April 2023. …”
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A nutritional biomarker score of the Mediterranean diet and incident type 2 diabetes: Integrated analysis of data from the MedLey randomised controlled trial and the EPIC-InterAct... by Jakub G Sobiecki, Fumiaki Imamura, Courtney R Davis, Stephen J Sharp, Albert Koulman, Jonathan M Hodgson, Marcela Guevara, Matthias B Schulze, Ju-Sheng Zheng, Claudia Agnoli, Catalina Bonet, Sandra M Colorado-Yohar, Guy Fagherazzi, Paul W Franks, Thomas E Gundersen, Franziska Jannasch, Rudolf Kaaks, Verena Katzke, Esther Molina-Montes, Peter M Nilsson, Domenico Palli, Salvatore Panico, Keren Papier, Olov Rolandsson, Carlotta Sacerdote, Anne Tjønneland, Tammy Y N Tong, Yvonne T van der Schouw, John Danesh, Adam S Butterworth, Elio Riboli, Karen J Murphy, Nicholas J Wareham, Nita G Forouhi

“…<h4>Methods and findings</h4>We derived a biomarker score based on 5 circulating carotenoids and 24 fatty acids that discriminated between the Mediterranean or habitual diet arms of a parallel design, 6-month partial-feeding randomised controlled trial (RCT) conducted between 2013 and 2014, the MedLey trial (128 participants out of 166 randomised). …”
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Dynamic history of the Central Plain and Haidai region inferred from Late Neolithic to Iron Age ancient human genomes by Hui Fang, Fawei Liang, Hao Ma, Rui Wang, Haifeng He, Limin Qiu, Le Tao, Kongyang Zhu, Weihua Wu, Long Ma, Huazhen Zhang, Shuqing Chen, Chao Zhu, Haodong Chen, Yu Xu, Yongsheng Zhao, Haiwang Liu, Chuan-Chao Wang

“…We provide a genetic parallel to the observation of a significant increase in rice farming in the middle and lower YR in the Longshan period. …”
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Task-sharing with lay counsellors to deliver a stepped care intervention to improve depression, antiretroviral therapy adherence and viral suppression in people living with HIV: a... by Kimberley Goldsmith, Barbara M Barrett, Dixon Chibanda, Melanie Abas, Conall O’Cleirigh, Walter Mangezi, Primrose Nyamayaro, Rebecca Jopling, Tarisai Bere, Samantha M McKetchnie, Calvin Fitch, Emily Saruchera, Thabani Muronzie, Denford Gudyanga, James Hakim, Steven A Safren

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