Sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: study protocol for a pragmatic randomised controlled tria... by Elizabeth Randell, Rachel McNamara, Sue Delport, Monica Busse, Richard P. Hastings, David Gillespie, Rhys Williams-Thomas, Lucy Brookes-Howell, Renee Romeo, Janet Boadu, Alka S. Ahuja, Anne Marie McKigney, Martin Knapp, Kathryn Smith, Jacqui Thornton, Gemma Warren

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Online Parent Training for The Initial Management of ADHD referrals (OPTIMA): the protocol for a randomised controlled trial of a digital parenting intervention implemented to supp... by Katarzyna Kostyrka-Allchorne, Claire Ballard, Sarah Byford, Samuele Cortese, David Daley, Johnny Downs, Blandine French, Cristine Glazebrook, Kimberley Goldsmith, Charlotte L. Hall, Ellen Hedstrom, Hanna Kovshoff, Jana Kreppner, Nancy Lean, Kapil Sayal, James Shearer, Emily Simonoff, Margaret Thompson, Edmund J. S. Sonuga-Barke

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Perimenopausal Effects of Estradiol on Anhedonia and Psychosis Study (PEEPs): study protocol for a neural and molecular mechanistic clinical trial by Melissa J. M. Walsh, Kathryn Gibson, Megan Hynd, Tory A. Eisenlohr-Moul, Erin C. Walsh, Lauren Schiff, Fred Jarskog, David Lalush, Gabriel S. Dichter, Crystal E. Schiller

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Response to the Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India” by Mounika Pillamarapu, Abhilash Mohan, Gayatri Saberwal

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Effects and mechanisms of supramaximal high-intensity interval training on extrapulmonary manifestations in people with and without chronic obstructive pulmonary disease (COPD-HIIT... by Johan Jakobsson, Chris Burtin, Mattias Hedlund, Carl-Johan Boraxbekk, Jonas Westman, Nina Karalija, Per Stål, Thomas Sandström, David Ruttens, Harry R. Gosker, Jana De Brandt, André Nyberg

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Standard requirements for GCP-compliant data management in multinational clinical trials by McPherson Gladys, Wittenberg Michael, Schade-Brittinger Carmen, Salas Nader, Lauritsen Jens, Canham Steve, Kuchinke Wolfgang, Ohmann Christian, McCourt John, Gueyffier Francois, Lorimer Andrea, Torres Ferràn

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Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo... by Benjamin Speich, Kathrin Bausch, Jan A. Roth, Lars G. Hemkens, Hannah Ewald, Deborah R. Vogt, Nicole Bruni, Stefanie Deuster, Hans-H. Seifert, Andreas F. Widmer

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A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan by Anna Heath, Juan David Rios, Sarah Williamson-Urquhart, Petros Pechlivanoglou, Martin Offringa, Christopher McCabe, Gareth Hopkin, Amy C. Plint, Andrew Dixon, Darcy Beer, Serge Gouin, Gary Joubert, Terry P. Klassen, Stephen B. Freedman, on behalf of the PERC-KIDSCAN DOSE-AGE Study Group

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Effect of the telemedicine-supported multicomponent exercise therapy in patients with knee osteoarthritis: study protocol for a randomized controlled trial by Yuan Feng, Yan Wu, Huizhen Liu, Tianjie Bao, Chongyang Wang, Zezhang Wang, Jielei Huang, Yiwei Jiang, Chengqi He, Siyi Zhu

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Protocol for a multi-phase, mixed methods study to develop and evaluate culturally adapted CBT to improve community mental health services for Canadians of south Asian origin by Farooq Naeem, Andrew Tuck, Baldev Mutta, Puneet Dhillon, Gary Thandi, Azaad Kassam, Nimo Farah, Aamna Ashraf, M. Ishrat Husain, M. Omair Husain, Helen-Maria Vasiliadis, Marcos Sanches, Tariq Munshi, Maureen Abbott, Nicholas Watters, Sean A. Kidd, Muhammad Ayub, Kwame McKenzie

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Process evaluation of a complex intervention to promote advance care planning in community-dwelling older persons (the STADPLAN study)—study protocol by Katharina Silies, Rieke Schnakenberg, Almuth Berg, Änne Kirchner, Henriette Langner, Juliane Köberlein-Neu, Gabriele Meyer, Falk Hoffmann, Sascha Köpke

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Evaluating the integration of HIV self-testing into low-resource health systems: study protocol for a cluster-randomized control trial from EQUIP Innovations by Kathryn Dovel, Frackson Shaba, Mike Nyirenda, O. Agatha Offorjebe, Kelvin Balakasi, Khumbo Phiri, Brooke Nichols, Chi-Hong Tseng, Ashley Bardon, Khumbo Ngona, Risa Hoffman

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Motivations for participating in a clinical trial on an avian influenza vaccine by Costas Laura, Bayas José M, Serrano Beatriz, Lafuente Sarah, Muñoz M-Amparo

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Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial by Kim Melchior, Ingmar Franken, Mathijs Deen, Colin van der Heiden

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Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial by Ahmed A. Abouarab, Jeremy R. Leonard, Lucas B. Ohmes, Christopher Lau, Lisa Q. Rong, Natalia S. Ivascu, Kane O. Pryor, Monica Munjal, Filippo Crea, Massimo Massetti, Tommaso Sanna, Leonard N. Girardi, Mario Gaudino

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Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide: study protocol for a randomized controlled trial in veterans by Melanie L. Bozzay, Jennifer M. Primack, Hannah R. Swearingen, Jennifer Barredo, Noah S. Philip

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Systematic Techniques to Enhance rEtention in Randomised controlled trials: the STEER study protocol by Katie Gillies, Peter Bower, Jim Elliott, Graeme MacLennan, Rumana S. N. Newlands, Margaret Ogden, Shaun P. Treweek, Mary Wells, Miles D. Witham, Bridget Young, Jill J. Francis

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Reduction of surgical site infection using a novel intervention (ROSSINI): study protocol for a randomised controlled trial by Calvert Melanie J, Bradbury Jennifer M, Gheorghe Adrian, Harrison Gareth, Futaba Kaori, Youssef Haney, Mak Tony, Hawkins William, Bartlett David C, Pinkney Thomas D, Dowswell George, Magill Laura, Redman Val, Wilson Sue, Leaper David, Morton Dion G

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Building internal capacity in pragmatic trials: a workshop for program scientists at the US National Cancer Institute by Wynne E. Norton, Merrick Zwarenstein, Susan Czajkowski, Elisabeth Kato, Ann O’Mara, Nonniekaye Shelburne, David A. Chambers, Kirsty Loudon

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OnTrack Chile for people with early psychosis: a study protocol for a Hybrid Type 1 trial by Franco Mascayano, Iruma Bello, Howard Andrews, Diego Arancibia, Tamara Arratia, María Soledad Burrone, Sarah Conover, Kim Fader, Maria Jose Jorquera, Mauricio Gomez, Sergio Malverde, Gonzalo Martínez-Alés, Jorge Ramírez, Gabriel Reginatto, Alexandra Restrepo-Henao, Robert A. Rosencheck, Sara Schilling, Thomas E. Smith, Gonzalo Soto-Brandt, Eric Tapia, Tamara Tapia, Paola Velasco, Melanie M. Wall, Lawrence H. Yang, Leopoldo J. Cabassa, Ezra Susser, Lisa Dixon, Rubén Alvarado

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