Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial by Richard Leigh, Elizabeth McGinnis, Peter Vowden, Roberta Longo, James Wason, Sarah Brown, Paul Chadwick, Catherine Fernandez, Linda Sharples, Ian Chetter, Jane Nixon, Myka Ransom, Rachael Gilberts, Frances Game, Chris Bojke, Akila Chandrasekar, Howard Collier, Shervanthi Homer-Vanniasinkam, Edward Jude, Richard Lomas, David Russell

“…Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence.Methods and analysis A multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. …”
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Effectiveness of an mHealth- and School-Based Health Education Program for Salt Reduction (EduSaltS) in China: Cluster Randomized Controlled Trial Within Scale-Up by Naibo Wang, Chen Wang, Puhong Zhang, Yinghua Li, Feng J He, Li Li, Yuan Li, Rong Luo, Dezhi Wan, Lewei Xu, Lifang Deng, Lei Wu

“…ObjectiveWe evaluated the effectiveness of the real-world implementation of an mHealth- and school-based health education scale-up program to reduce salt intake (EduSaltS [mHealth and school-based education program to reduce salt intake scaling up in China]). MethodsA parallel cluster randomized controlled trial was conducted from April 2022 to July 2023 across 20 schools in 2 districts and 2 counties within Ganzhou City, Jiangxi Province, China. …”
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Telephone lifestyle intervention to prevent diabetes in women with recent gestational diabetes mellitus attending the national health system: the LINDA-Brasil clinical trial by Bruce B Duncan, Maria Inês Schmidt, Paula A Bracco, Maria A Nunes, Kadhija A Cherubini, Cristina D Castilhos, Jainara Z Spagiari, Leony M Galliano, Ruben Ladwig, Fabricio B Del Vecchio, Anelita H M Del Vecchio, Michele Drehmer, Adriana Costa Forti, Cristina Façanha, Lenita Zajdenverg, Bianca de Almeida-Pititto, Rosângela Roginski Réa, Patrícia Medici Dualib

“…The COVID-19 pandemic negatively impacted trial conduction.Trial registration number NCT02327286.…”
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Study protocol: Minimum effective low dose: anti-human thymocyte globulin (MELD-ATG): phase II, dose ranging, efficacy study of antithymocyte globulin (ATG) within 6 weeks of diagn... by Simon Bond, David Dunger, Mark Wilson, Adrian Mander, Mikael Knip, Anita Chhabra, M Loredana Marcovecchio, Charlotte S Wilhelm-Benartzi, Michael J Haller, Timothy Tree, Hilde Morobé, Sarah E Miller, Sylvaine Bruggraber, Diane Picton, Katrina Gatley, A Emile J Hendriks, Bärbel Aschemeier-Fuchs, Lut Overbergh, Jaivier Pall, Olivier Arnaud, Almut Nitsche, Anke M Schulte

“…The publication policy is set in the INNODIA (An innovative approach towards understanding and arresting Type 1 diabetes consortium) grant agreement (www.innodia.eu).Trial registration number NCT03936634; Pre-results.…”
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Digital education and exercise therapy versus minimal intervention for young people at high risk of early onset knee osteoarthritis after ACL reconstruction: a study protocol for t... by Jackie L. Whittaker, Amanda Cammalleri, Candice Archibald, Alexandra Brooks-Hill, Patrick Chin, Sarah Clark, Jennifer C. Davis, Alison M. Hoens, Michael A. Hunt, Karin Kausky, Angelina Ko, Lise Leveille, Linda C. Li, Parth Lodhia, Justin M. Losciale, Maxi Miciak, Amber D. Mosewich, Adnan Sheikh, Trish Silvester-Lee, Linda K. Truong, Dominic Wade, David R. Wilson, Hui Xie, Xian He Yan, Ewa M. Roos

“…Methods The Stop OsteoARthritis (SOAR) study is a parallel, two-arm, assessor-blinded, superiority, hybrid effectiveness-implementation type 1 randomized controlled trial. …”
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Targeted heart rate control using the funny current inhibitor ivabradine to reduce morbidity in patients undergoing noncardiac surgery: study protocol for a phase 2a, triple-blind,... by Bernardo Bollen Pinto, Benjamin Shelley, Priyanthi Dias, Salma Begum, Florence Ennahdi-Elidrissi, Tom E.F. Abbott, Russell Hewson, Akshaykumar Patel, Kamran Khan, Rupert M. Pearse, Gareth L. Ackland, Bernardo Bollen Pinto, Benjamin Shelley, Priyanthi Dias, Salma Begum, Florence Ennahdi-Elidrissi, Russell Hewson, Anna Wozniak, Shaun M. May, Mareena Joseph, Agustine Miguel Saavedra, Tim Martin, Onika Ottley, Ana Santos, Fatima Seidu, Stéphanie Mulin, Stéphane Luise, Isabelle Pichon, John Daniels, Béatrice Gil-Wey, Soraya Bicher, Gaël Rais, Christene Aitken, Elizabeth Boyd, Patricia Griffen, Charlene Hamilton, Kathryn Valdeavella, Rhiannon McAreavey, Phillip McCall, Alfie Lloyd, Jocelyn Barr, Julie Buckley, Anne Marie Tiah, Henrike Janssen, Lisa Kandala, Angela Fitzpatrick, Alexander Lysomirski, Ahmed Ahltobi, Ana Gutierrez del Arroyo, Tom E.F. Abbott, Akshaykumar Patel, Kamran Khan, Rupert M. Pearse, Gareth L. Ackland

“…Methods: This triple-blind, international, multicentre, randomised, placebo-controlled, parallel group randomised trial will recruit 350 patients, aged ≥55 yr, with cardiovascular risk factors for myocardial injury during elective noncardiac surgery. …”
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Effectiveness of socioecological model-guided, smart device-based, and self-management-oriented lifestyle (3SLIFE) intervention on healthy lifestyles and metabolic syndrome risk in... by Bin Yu, Yuchen Li, Chunlan Ma, Jan D. Reinhardt, Qingyu Dou, Haojiang Zuo, Xue Yang, Ming Li, Changwei Cai, Yunzhe Fan, Zixing Huang, Tong Pang, Qi Tang, Fen Yang, Tingting Ye, Peng Jia, Shujuan Yang

“…This study applies 3SLIFE to community-dwelling adults, aiming to improve healthy lifestyles. Methods In this parallel, cluster-randomized controlled trial, 20 communities in Southwestern China were randomly assigned 1:1 to either the intervention or control group. …”
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The PIKASO trial (Preventing Injured Knees from Osteoarthritis: Severity Outcomes): Rationale and design features for a randomized controlled trial by Cale A. Jacobs, Morgan H. Jones, Jamie E. Collins, Lily M. Waddell, Xiaojuan Li, Carl S. Winalski, Brian Pietrosimone, Virginia Byers Kraus, Miguel Otero, Elizabeth Wellsandt, Laura C. Schmitt, Kurt P. Spindler, Donald D. Anderson, Scott A. Rodeo, Robert A. Magnussen, Brian R. Wolf, Joe M. Hart, Austin V. Stone, Caitlin E. Conley, Yvonne M. Golightly, Gregory D. Myer, Lynn Snyder-Mackler, Martin K. Lotz, Jason S. Kim, Michelle M. McLeod, Janet L. Huebner, Caroline Lisee, Faith Selzer, Jeffrey N. Katz, Kyna Long, Kelly C. Frier, Daniel J. Betensky, David T. Felson, Elena Losina

“…Methods: Preventing Injured Knees from OsteoArthritis: Severity Outcomes (PIKASO) is a multicenter blinded, parallel, two-arm randomized controlled trial of 512 individuals aged 18–45 years undergoing anterior cruciate ligament reconstruction (ACLR). …”
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Efficacy and safety of combined nebulization of unfractionated heparin, acetylcysteine, budesonide and ipratropium bromide in hospitalised patients with COVID-19 pneumonia: a rando... by Junhui Gong, Naifu Nie, Minrui Jiang, Xinyu Yang, Qinghua Wang, Jia Deng, Jun Kang, Xin Li, Li Zhang, Ying Zhang, Nuo Luo, Xiaoyi Du, Ling Wang, Wei Zhou, Hui Cao, Kunlin Li, Guoqiang Cao, Li Li

“…Methods This single-center, open-label, randomized, parallel-group trial was conducted at a tertiary hospital in China. …”
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Web-based mindfulness and skills-based distress reduction for patients with cancer: study protocol of the multicentre, randomised, controlled confirmatory intervention trial Reduct by Dirk Schadendorf, Peter Martus, Stephan Zipfel, Yesim Erim, Alexander Bäuerle, Martin Teufel, Caterina Schug, Johanna Graf, Wolfgang Bethge, Andreas Dinkel, Anja Neumann, Jasmin Steinbach, Jana Heinen, Julia Barbara Krakowczyk, Mirjam Damerau, Sebastian Dries, Anja Mehnert-Theuerkauf, Mitra Tewes, Jörg Wiltink, Alexander Wünsch

“…Results will be published in peer-reviewed journals, conference presentations, the project website, and among self-help organisations.Trial registration number German Clinical Trial Register (DRKS); DRKS-ID: DRKS00025213.…”
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CTN 328: immunogenicity outcomes in people living with HIV in Canada following vaccination for COVID-19 (HIV-COV): protocol for an observational cohort study by Cecilia T Costiniuk, Jean-Pierre Routy, Shari Margolese, Enrico Mandarino, Joel Singer, Mohammad-Ali Jenabian, Mario Ostrowski, Jonathan B Angel, Ann Burchell, Darrell Tan, Colin Kovacs, Mark Hull, Mark Brockman, Sharon Walmsley, Aslam H Anis, Marianne Harris, Curtis Cooper, Marc-André Langlois, Iva Kulic, Judy Needham, Zabrina Brumme

“…Data for 1000 HIV-negative controls will be obtained via a parallel cohort study (Stop the Spread Ottawa), using similar time points and methods. …”
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A legume-enriched diet improves metabolic health in prediabetes mediated through gut microbiome: a randomized controlled trial by Xiaorong Wu, Alvin Surya Tjahyo, Vera Sergeyevna Brok Volchanskaya, Long Hui Wong, Xianning Lai, Yi Ning Yong, Farhana Osman, Shia Lyn Tay, Priya Govindharajulu, Shalini Ponnalagu, Rachel Tso, Hwee Sze Teo, Kaijie Khoo, Huan Fan, Chew Chan Goh, Clara Poh Lian Yap, Melvin Khee-Shing Leow, Christiani Jeyakumar Henry, Sumanto Haldar, Kevin Junliang Lim

“…The study was a 16-week, single-blind, parallel-design, randomized controlled trial (n = 63 intervention group (IG), n = 64 control group (CG); mean ± SD age 62.2 ± 6.3 years, BMI 23.8 ± 2.6 kg/m2). …”
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The SmartNTx-study: a prospective, randomized controlled trial to investigate additional interventional telemedical management versus standard aftercare in kidney transplant recipi... by Mario Schiffer, Lars Pape, Julia K. Wolff, Julia K. Wolff, Raoul Gertges, Vanessa Visconti, Karen Reichert, Anja Pfau, Anne Dieterle, Katja Sauerstein, Andreas Kribben, Kristina Boss, Sinem Karaterzi, Felix Nensa, Philipp Winneckens, Mario Cypko, Mario Cypko, Wiebke Duettmann, Bianca Zukunft, Eva Schrezenmeier, Marcel G. Naik, Fabian Halleck, Roland Roller, Sebastian Möller, Sebastian Möller, Oliver Amft, Oliver Amft, Klemens Budde

“…However, stand-alone apps have limitations and ideally, the mHealth solutions are embedded in a holistic treatment approach, including healthcare professionals.MethodsWe will conduct a 1-year, prospective, randomized, 2-armed, parallel group multicenter trial in three German Kidney Transplant Centers (KTCs) to demonstrate that additional and continuous interventional telemedical management will improve health after kidney transplantation in patients of all ages. …”
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Results of a feasibility study of the FReSH START intervention to improve quality of life and other outcomes in people who repeatedly self-harm (Function REplacement in repeated Se... by Bethan Copsey, Alexandra Wright-Hughes, Amanda Farrin, Cara Gates, Kate Farley, Cathy Brennan, Dean McMillan, Christopher D. Graham, Chris Bojke, Richard Mattock, Adam Martin, Petra Bijsterveld, Judith Horrocks, Suzanne Hartley, Marsha McAdam, Dafydd Hammond-Jones, Louise D. Bryant, Allan House, Elspeth Guthrie, the FReSH START lived experience group

“…Follow-up was via participant reported outcomes using postal questionnaires at 6 months and monthly text messages. A parallel qualitative study interviewed a sample of therapists and participants to refine the intervention and logic model ahead of a definitive RCT. …”
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Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial by Ingrid Muller, Miriam Santer, Beth Stuart, Paul Little, Matthew J Ridd, Karen Thomas, Nick Francis, Kim S Thomas, Gareth Griffiths, Natalia V Permyakova, Jacqui Nuttall, Irene Soulsby, Alison M Layton, Tracey H Sach, Sarah Pyne, Susanne Renz, Zina Eminton, Megan Lawrence

“…Compared with no active systemic treatment, spironolactone was estimated to be marginally cost-effective where multiple imputation was performed but was not cost-effective in complete case analysis.Trial registration number ISRCTN registry (ISRCTN12892056).…”
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Future Proofing Study: a cluster randomised controlled trial evaluating the effectiveness of a universal school-based cognitive–behavioural programme for adolescent depression by Maree Teesson, Helen Christensen, Svetha Venkatesh, Aliza Werner-Seidler, Lara Johnston, Bridianne O’Dea, Michelle Torok, Katharine Steinbeck, Raghu Lingam, Andrew Mackinnon, Yael Perry, Kit Huckvale, Joanne R Beames, Alison L Calear, Kate Maston, Philip J Batterham, Ju Lee Oei, Mark E Larsen, Jennifer L Hudson, Lyndsay Brown, Hiroko Fujimoto, Alexandra Batholomew, Debopriyo Bal, Susan Rachel Skinner, Katherine M Boydell, Susanne Schweizer

“…However, high-quality, large-scale trials are lacking.Objective The aim was to examine whether a digital cognitive–behavioural programme (‘SPARX’), delivered at scale in schools, would reduce depressive symptoms 12 months later.Methods A cluster randomised controlled trial with parallel arms (intervention; control) was conducted in Australian schools, between August 2019 and December 2022. …”
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Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence in Type 2 Diabetes (MOTIVATE-T2D): a decentralised feasibility randomised controlled trial delivered ac... by Joel Singer, Helen Jones, Céu Mateus, Charlotte A Jones, Jonathan Little, Victoria S Sprung, Mary E Jung, Robert Andrews, Alison M McManus, Richard Pulsford, Katie Hesketh, Jonathan Low, Matthew Cocks, Benjamin Buckley, Sandra Blitz, Kaja Falkenhain, Jennifer Job, Sarah L Percival, Catherine L Russon

“…Objectives Assess the feasibility of a mobile health (mHealth)-supported home-delivered physical activity (PA) intervention (MOTIVATE-T2D) in people with recently diagnosed type 2 diabetes (T2D).Design Feasibility multicentre, parallel group, randomised controlled trial (RCT).Setting Participants were recruited from England and Canada using a decentralised design.Participants Adults (40–75 years) recently diagnosed with T2D (5–24 months).Interventions Participants were randomised 1:1 to intervention (MOTIVATE-T2D) or active control groups. …”
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mHealth Social Support Versus Standard Support for Diabetes Management in Safety-Net Emergency Department Patients: Randomized Phase-III Trial by Elizabeth Burner, Danielle Hazime, Michael Menchine, Wendy Mack, Janisse Mercado, Adriana Aleman, Antonio Hernandez Saenz, Sanjay Arora, Shinyi Wu

“…ObjectiveWe assessed outcomes of an unblinded, parallel, equal-allocation randomized phase-III trial that tested a social support mHealth intervention to improve emergency department patients’ diabetes self-management. …”
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Effect of communicating genetic risk of type 2 diabetes and wearable technologies on wearable device-measured behavioural outcomes in East Asians: protocol of a randomised controll... by Youngwon Kim, Shan Lou, Brian Chung, Simon Griffin, Ziyuan Chen, Job G Godino, Flora Lai Tung Cheung, Michael Multhaup, Derwin King Chung K C Chan, Harrison Hin Sheung Ho, Tsz Him Timothy Tse, Shiu Lun Ryan Au Yeung, Joni H Zhang, Mengyao Wang

“…We aim to assess the effects of communicating genetic risk for T2D alone or in combination with wearable device functions on wearable device-measured PA among overweight or obese East Asians.Methods and analysis In a parallel group, randomised controlled trial, 355 overweight or obese East Asian individuals aged 40–60 years are allocated into one of three groups: one control and two intervention groups. …”
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Prospective multicentre randomised clinical trial comparing survival rates, quality of life and nutritional status between advanced gastric cancer patients with different follow-up... by Hyuk-Joon Lee, Moon-Won Yoo, Min-Hee Ryu, Bang Wool Eom, Dong-Hoe Koo, Ji Yeong An, Han Hong Lee, Hyoung-Il Kim, Hoon Hur, Su Mi Kim, Ji-Ho Park, Jae Seok Min, Kyung Won Seo, Sang-Ho Jeong, Oh Jeong, Oh Kyoung Kwon, Seung Wan Ryu, Chang Hak Yoo, Jae Moon Bae, Keun Won Ryu

“…This study will be disseminated through peer-reviewed publications, national or international conferences.Trial registration number NCT04740346.…”
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