ARC (Australian Rotator Cuff) trial: study protocol for a randomised placebo-controlled trial comparing rotator cuff repair to no repair during arthroscopic shoulder surgery for pe... by Ian A. Harris, Richard S. Page, Rachelle Buchbinder, Ville Äärimaa, Sam Adie, Graeme Brown, Nancy Cinnadaio, Maurizio Damiani, Joseph Descallar, Manuela L. Ferreira, Nadine E. Foster, Stephen Gill, Katrina Hutchison, Teppo Järvinen, Oliver Khoo, David Lieu, Christopher G. Maher, Justine M. Naylor, Geoff Smith, Luke Spencer, Yvana Toh, Andrew Whan, Tim Yeoh

“…Methods The study is a multicentre two-parallel arm, blinded, individually randomised controlled trial (RCT). …”
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Enhancing Quadruple Health Outcomes After Thoracic Surgery: Feasibility Pilot Randomized Controlled Trial Using Digital Home Monitoring by Mahesh Nagappa, Yamini Subramani, Homer Yang, Natasha Wood, Jill Querney, Lee-Anne Fochesato, Derek Nguyen, Nida Fatima, Janet Martin, Ava John-Baptiste, Rahul Nayak, Mehdi Qiabi, Richard Inculet, Dalilah Fortin, Richard Malthaner

“…MethodsWe conducted a 2-arm parallel-group pilot RCT at a single tertiary care center. …”
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SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid by Odette Linda Kamdem, Caroline Dupre, Valdez Heugno, Amandine Baudot, Estelle Essangui, Marie Blanquet, Nina Guercon, Marie Fanget, Sasha Bayet, Marie Pierre Vericel, Pauline Oustric, Yves Mbama Biloa, Elie Shikitele Lola, Mabrouk Nekaa, Mario Debellis, François Stierlam, Ronelle Fabiola Mbia, Olivier Tatsilong, Peguy Assomo Ndemba, Williams Bell Ngan, Valérie Ndobo, Clarisse Ayina Ayina, Jerson Mekoulou, Marie Solange Ndom Ebongue, Thomas Celarier, Louise Ruiz, Veronique Regnier, Claude Bika, Françoise Ngo Sack, Judith Laure Ngondi, Nathalie Barth, Samuel Honore Mandengue, Frederic Roche, Elisabeth Botelho-nevers, Carole Else Eboumbou Moukoko, Céline Nguefeu Nkenfou, David Hupin, Bienvenu Bongue, Jessica Guyot

“…Methods To achieve our objectives, we have planned to carry out a prospective, multicentre, two-arm randomized controlled trial with a convergent parallel mixed methods design. Two countries are involved in this study: France and Cameroon. …”
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Low-added sugar dietary intervention study to mitigate glucose intolerance and improve body composition in adults with cystic fibrosis: a protocol of a double-blind, randomised stu... by Priyathama Vellanki, Kirk Easley, Terryl J Hartman, Thomas R Ziegler, Puneet Sharma, Swati Zaveri, Arlene Stecenko, William R Hunt, Amy Goss, Joshua D Chandler, Tasha M Burley, Chris Driggers, Amy Ciccarella, Heather Zhou, Kristen Narlow, Tanicia Daley, Jessica Alvarez

“…Authorship for any resulting publications will follow the guidelines established by the International Committee of Medical Journal Editors.Trial registration number This research study is registered at www.Clinicaltrials.gov (NCT05766774).…”
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Effectiveness of primary-contact physiotherapy in managing musculoskeletal conditions in emergency departments: protocol for the RESHAP-ED randomised controlled trial by Rachelle Buchbinder, Andrew Lawson, Bethan Richards, Kirsten Howard, Vasi Naganathan, Michael Dinh, Kirsten McCaffery, Thomas Lung, Laurent Billot, Ian Harris, Gustavo C Machado, James Edwards, Eileen Rogan, Andrew Wong, John Wiggers, Chris Maher, Danielle Coombs, Narcyz Ghinea, Leigh Kinsman, Christopher Williams, Tarcisio F de Campos, Chelsea Hall, Lisa Harvey, Hatem Alkhouri, Katherine Maka, Teresa Anderson, Andrew Bailey, Chathurani Sigera, Qiuzhe Chen, Alla Melman, Allison Moore, Owen Hutchings, Helen Goldsmith, John-Paul Smiles, Gabriel Lau, Peter Youseff, Ian Liang, Chantay Lenord, Ruth Perrott, Julie Penn, Stephen Spennati, Rebecca Ormerod, Samuel Folbigg, Laura Butterworth, Frederico Estermann, Sarah Attree, Samuel Boughton, Prue Neely, Amy Wigham, Angelo Efthimiou, Hui-Te Ku, Sarah Kammoun, Breanna Frendo, Patrick Law, Sharon Xu

“…Primary-contact physiotherapists could play a greater role in supporting ED physician and nursing staff in the management of patients presenting to the ED with musculoskeletal conditions.Methods and analysis The RESHAP-ED trial is a multicentre, pragmatic, open-label, two-arm, parallel randomised controlled trial with nested process and economic evaluations. …”
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Urolithin A supplementation to improve endothelial and cerebrovascular function in middle-aged adults with obesity: Study protocol for a double-blind placebo-controlled randomized... by Ana Clara da C. Pinaffi-Langley, Camila B. Pinto, Zsofia Szarvas, Anna Peterfi, Zalan Kaposzta, Peter Mukli, Mihaly Muranyi, Cameron D. Owens, Cheryl Adams, Ali Shahriari, Henry Kinnard, Jr., Bryan Ticer, Leah Anderson, Stefano Tarantini, Yan Daniel Zhao, Norman G. Hord, Andriy Yabluchanskiy

“…Methods: This study is a placebo-controlled, double-blind, randomized, parallel interventional trial. Eligible participants are between 40–64 years old and have a BMI ≥30 kg/m2. …”
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Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial by Yaseen M Arabi, Khalid Alghamdi, Eman Al Qasim, Fahad Al-Hameed, Haytham Tlayjeh, Mohammed Almaani, Zohair Al aseri, Sara Aldekhyl, Hasan M Al-Dorzi, Sheryl Ann Abdukahil, Mohammad Khulaif Al Harbi, Husain Al Haji, Mohammed Al Mutairi, Omar Al Zumai, Wedyan Al Wehaibi, Saad Al Qahtani, Jamal Chalabi, Mohammed Alshahrani, Talal Albrahim, Abdulrahman Alharthy, Ahmed Mady, Abdulhadi Bin Eshaq, Ali A Al bshabshe, Zainab Al Duhailib, Ayman Kharaba, Rakan Alqahtani, Adnan Al Ghamdi, Ali Altalag, Haifa Algethamy, Ahmad Al Aqeily, Faisal Al Baseet, Hashem Al Samannoudi, Mohammed Al Obaidi, Yassin T Ismaiel, Abdulrahman A Al-Fares

“…Our findings will be published in peer-reviewed journals and presented at relevant conferences and meetings.Trial registration number NCT04477668.…”
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Carer administration of as-needed subcutaneous medication for breakthrough symptoms in people dying at home: the CARiAD feasibility RCT by Zoë Hoare, Clare Wilkinson, Dyfrig A Hughes, Anthony Byrne, Annmarie Nelson, Julia Hiscock, Bee Wee, Marlise Poolman, Annie Hendry, Stella Wright, Paul Perkins, Anne Parkinson, Emily Holmes, Liz Reymond, Betty Foster, Julie O’Connor, Penney Lewis, Nia Goulden, Rossella Roberts, Sian Roberts

“…This will help to ascertain if there are unanswered questions to be studied in a trial.Trial registration number ISRCTN11211024.…”
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A holistic approach to promoting early child development: a cluster randomised trial of a group-based, multicomponent intervention in rural Bangladesh by Stephen P Luby, Mahbubur Rahman, Fahmida Tofail, Lia CH Fernald, Esther O Chung, Helen O Pitchik, Fahmida Akter, Jesmin Sultana, Abul Kasham Shoab, Tarique Md. Nurul Huda, Tania Jahir, Md Ruhul Amin, Md Khobair Hossain, Jyoti Bhushan Das, Kendra A Byrd, Farzana Yeasmin, Laura H Kwong, Jenna E Forsyth, Malay K Mridha, Peter J Winch

“…We evaluated a multicomponent, group-based early child development intervention including behavioural recommendations on responsive stimulation, nutrition, water, sanitation, hygiene, mental health and lead exposure prevention.Methods We conducted a 9-month, parallel, multiarm, cluster-randomised controlled trial in 31 rural villages in Kishoreganj District, Bangladesh. …”
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Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, int... by Anne B Chang, Keith Grimwood, Yuejen Zhao, Gabrielle B McCallum, Catherine A Byrnes, Heidi Smith-Vaughan, Peter S Morris, Christine Connors, Adrian Trenholme, Shirley Lawrence, Joshua Francis, Kobi L Schutz, Mark D Chatfield, Nevio Sarmento, Robyn L. Marsh, Emily R Bowden, Nicholas Fancourt, Adriano Vieira, Kim M Hare, Dennis Bonney, Felicity Marwick, Bronwyn Karvonen, Carolyn Maclennan, Milena Santos Lay, Endang Soares da Silva

“…Our primary hypothesis is that children receiving long-term azithromycin will have fewer medically attended ALRIs over the intervention period than those receiving placebo.Methods and analysis We will recruit 160 Australian and New Zealand First Nations and Timorese children aged <2 years to a parallel, superiority RCT across four hospitals from three countries (Australia, New Zealand and Timor-Leste). …”
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Selective neoadjuvant therapy of rectal cancer patients (SELREC): study protocol for a European randomised controlled, open, multicentre non-inferiority trial by Markus W Büchler, Lukas Baumann, Peter Schirmacher, Christoph W Michalski, Markus K Diener, Dirk Jäger, Pascal Probst, Mohammed Al-Saeedi, Martin Schneider, Alexis Ulrich, Constantin Schwab, Anja Sander, Christina Klose, Christoph Kahlert, Hans-Ulrich Kauczor, Jürgen Debus, Rosa Klotz, Solveig Tenckhoff, Cosima Engerer, Kristin Uzun-Lang, Caroline Wild, Bruno C Köhler

“…That treatment approach may show fewer adverse effects and be more cost-effective.Methods and analysis Selective neoadjuvant therapy of rectal cancer patients (SELREC) is a randomised controlled, parallel-group, open, multicentre, non-inferiority trial. …”
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Safe shortening of antibiotic treatment duration for complicated Staphylococcus aureus bacteraemia (SAFE trial): protocol for a randomised, controlled, open-label, non-inferiority... by N Roescher, JM Prins, JTM van der Meer, HI Bax, R Soetekouw, MGJ de Boer, LBS Gelinck, JJ Oosterheert, MA van Agtmael, M Berrevoets, DTP Buis, CH van Werkhoven, MJM Bonten, JE Bosmans, J Branger, S Douiyeb, E Jong, AJJ Lammers, E Sieswerda, JE Stalenhoef, TW Van der Vaart, EA Bij de Vaate, NJ Verkaik, MGA Van Vonderen, PJ De Vries, KCE Sigaloff, E Botman, A Van den Broek, L Buitenhuis, E Buitenwerf, A S Cents, N Engels, J L J Hanssen, A J Meinders, F P N Mollema, L Nagelmaker, M L M van Doorn-Schepens, P Thomopoulos, M Timmer, B van der Wiel

“…Results of the study will be published in a peer-reviewed journal.Trial registration number NL8347 (the Netherlands Trial Register).…”
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Effectiveness of biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: the BATCH RCT by Cherry-Ann Waldron, Philip Pallmann, Simon Schoenbuchner, Debbie Harris, Lucy Brookes-Howell, Céu Mateus, Jolanta Bernatoniene, Katrina Cathie, Saul N Faust, Josie Henley, Lucy Hinds, Kerry Hood, Chao Huang, Sarah Jones, Sarah Kotecha, Sarah Milosevic, Helen Nabwera, Sanjay Patel, Stéphane Paulus, Colin VE Powell, Jenny Preston, Huasheng Xiang, Emma Thomas-Jones, Enitan D Carrol

“…Design A pragmatic, multicentre, open-label, parallel two-arm, individually randomised controlled trial with internal pilot phase, qualitative study and health economic evaluations. …”
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Assessing dual use risks in AI research: necessity, challenges and mitigation strategies by Andreas Brenneis

“…The need for tailored ethics review processes is articulated, drawing parallels with medical research ethics committees.…”
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Efficacy and safety of intensive triglyceride-lowering therapy on reducing recurrence of hypertriglyceridemia-associated pancreatitis (REDUCE): protocol for a multicentre, randomis... by Tao Chen, Weiqin Li, Chunping Zhu, Na Liu, Xin Xu, Lihui Deng, Dong Wu, Yao Wu, Jianhua Wan, Xin Huang, Lu Ke, Wenhua He, Hongwei Zhang, Duan Wang, Nong-Hua Lu, Yin Zhu, Ling Ding, Jianing Li, Jianwen Sheng, Nonghua Lu, Huifang Xiong, Liang Xia, Gaifang Liu, Jinyi Sheng, Lingyu Luo, Yupeng Lei, Huajing Ke, Lanting Wang, Shihang Zhang, Zhihua Tang, Youshun Liu, Guan Gui, Yingjie Chen, Yinyu Pan

“…The results of this study will be published in peer-reviewed journals and reported at international conferences.Trial registration number ChiCTR2300073483 (Chinese Clinical Trial Registry)Protocol version V.4.0 (2024).…”
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The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial [version 2; peer review: 1 approved, 2 approved wit... by Paul Leighton, Wei Chern Gavin Fong, Ingrid Muller, Laura Howells, Arabella Baker, Eleanor J Mitchell, Eleanor Harrison, Leila Thuma, Yimin Jiang, Lucy Bradshaw, Alan Montgomery, Fiona Cowdel, Matthew J Ridd, Jane Ravenscroft, Reiko J Tanaka, Miriam Santer, Richard Swinden, Nicholas Hilken, Carron Layfield, Richard Dooley, Sophia Collins, Clare Upton, Tracy Owen, Firoza Davies, Devin Patel, Mars Eddis-Finbow, Hywel C Williams, Goldie Putrym, Kim S Thomas, Amanda Roberts

“…Methods This is an online, two-arm, parallel-group superiority RCT with internal pilot phase. …”
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CD22-targeted chimeric antigen receptor-modified T cells for children and adults with relapse of B-cell acute lymphoblastic leukemia after CD19-directed immunotherapy by Clare Taylor, Carl H June, Joseph A Fraietta, Boris Engels, Gabriela Plesa, Marco Ruella, Stephan A Grupp, Hongyan Liu, Colleen Callahan, Shannon L Maude, Regina M Myers, Caroline Diorio, Yimei Li, Vanessa Gonzalez, Julie K Jadlowsky, Amanda M DiNofia, Gerald Wertheim, Donald L Siegel, Emma Iannone, Laura Shinehouse, Jennifer L Brogdon, Elizabeth O Hexner, Diane Baniewicz, Richard Aplenc, Allison Barz Leahy, Susan E McClory, Susan R Rheingold, Lisa Wray, Noelle V Frey

“…Novel immunotherapeutic strategies for this patient population are urgently needed.Methods We tested a novel, fully human anti-CD22/4-1BB CAR T-cell construct, CART22-65s, in parallel phase I studies for pediatric and adult B-ALL. …”
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Six months of hybrid closed-loop therapy improves diabetes-specific positive well-being, and reduces diabetes distress and fear of hypoglycemia: secondary analysis of a randomized... by Anthony C Keech, Vijaya Sundararajan, Bruce R King, Sara Vogrin, Richard J MacIsaac, Leon A Bach, Jane Speight, Alicia J Jenkins, Christel Hendrieckx, David O’Neal, Sybil A McAuley, Geoff R Ambler, Fergus J Cameron, Jan M Fairchild, Elizabeth A Davis, Timothy W Jones, Morton G Burt, Philip M Clarke, Neale D Cohen, Peter G Colman, Joey Kaye, Kavita Kumareswaran, Melissa H Lee, Roland W Mccallum, Barbora Paldus, Stephen N Stranks, Steven Trawley, Glenn M Ward, David N O’Neal, Sienna Russell-Green, Deborah Jane Holmes-Walker, Benjamin Lam, Jennifer A Halliday, Glenn Ward, Catriona M Sims, D Jane Holmes-Walker, Andrzej Januszewski, Hanafi Mohammed Husin, Martin I de Bock, Mary B Abraham

“…Introduction This analysis aimed to investigate diabetes-specific psychological outcomes among adults with type 1 diabetes (T1D) using hybrid closed-loop (HCL) versus standard therapy.Research design and methods In this multicenter, open-label, randomized, controlled, parallel-group clinical trial, adults with T1D were allocated to 26 weeks of HCL (MiniMed™ 670G) or standard therapy (insulin pump or multiple daily injections without real-time continuous glucose monitoring). …”
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Effectiveness of Kushal Maa, a group-based mhealth interactive education and social support intervention for maternal and neonatal health outcomes: study protocol for a multisite r... by Praveen Kumar, Lakshmi Gopalakrishnan, Nadia Diamond-Smith, Azaz Khan, Abhishek Singh, Rashmi Bagga, Alison M El Ayadi, Anant Bhan, Alka Ahuja, Pushpendra Singh, Mona Duggal, Jasmeet Kaur, Deepak Tugnawat, Tracy Lin, Sujata Saunik, Garima Singh Verma, Shailendrakumar Gujarathi, Dinesh Chandke, Shashi Kant Dhir, Supriya Dhakne-Palwe, Mrunal Patil, Sonam Kumar, Nitin Vasaikar, Laura Weil

“…Results will be published in academic journals and presented at conferences.Trial registration number ClinicalTrials.gov: NCT05268588 Clinical Trials Registry – India: CTRI/2022/07/043889.…”
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Neurological outcomes with hypothermia versus normothermia in patients with moderate initial illness severity following resuscitation from out-of-hospital cardiac arrest: protocol... by Takeyuki Kiguchi, Taku Iwami, Yohei Okada, Tadashi Ishihara, Yusuke Ito, Yoshitaka Ogata, Takayuki Ogura, Tetsuya Yumoto, Hiromichi Narumiya, Hiroyuki Honda, Hisashi Dote, Hiromichi Naito, Takashi Yorifuji, Hiroki Maeyama, Atsunori Nakao, Hiroyuki Tanaka, Yuichi Okano, Hidetada Fukushima, Kei Nishiyama, YASUHIRO KURODA, Tetsuro Nikai, Taka-aki Nakada, Akihito Tampo, Mitsuaki Nishikimi, Ryosuke Ishida, Naofumi Bunya, Takayuki Otani, Masaaki Sakuraya, Kazuki Nishida, Shigeyuki Matsui, Tsuruta Ryosuke, Koichi Hayakawa, Toshihiro Sakurai, Shota Nakao, Ryuhei Igeta, Shoichiro Nohara, Junichi Maruyama, Midori Tsuchiya, Nao Tsukamoto, Tomoko Sato, Chikaaki Nakamichi, Tatsuya Miyakoshi, Satoshi Kikuchi, Futoshi Nagashima, Jun Sato

“…Results will be disseminated via publications and presentations.Trial registration number jRCT1062220035.…”
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