Ausgabe 1/2020
Inhalt (1011 Artikel)
Pre-operative anxiolysis in children through a combined pharmacological therapy with hydroxyzine and a non-pharmacological distraction technique with a clown (SONRISA): study protocol for randomised double-blind clinical trial
Esther Aleo Luján, Amanda Lopez-Picado, Ana Rivas, Belén Joyanes Abancens, Marina Laura Rodríguez Rojo, Patricia Fernández García, Carmen Soto Beauregard, Jaime Rodríguez Alarcón, Carlos González Perrino, Borja San Pedro de Urquiza, Eva Arias, Diamelis Rodriguez, Carmen Esteban Polonio, Maria José Torrejón
A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study
Aliza Werner-Seidler, Kit Huckvale, Mark E. Larsen, Alison L. Calear, Kate Maston, Lara Johnston, Michelle Torok, Bridianne O’Dea, Philip J. Batterham, Susanne Schweizer, S. Rachel Skinner, Katharine Steinbeck, Julie Ratcliffe, Ju-Lee Oei, George Patton, Iana Wong, Joanne Beames, Quincy J. J. Wong, Raghu Lingam, Katherine Boydell, Allison M. Salmon, Nicole Cockayne, Andrew Mackinnon, Helen Christensen
Ketogenic diet and fasting diet as Nutritional Approaches in Multiple Sclerosis (NAMS): protocol of a randomized controlled study
Lina Samira Bahr, Markus Bock, Daniela Liebscher, Judith Bellmann-Strobl, Liane Franz, Alexandra Prüß, Dania Schumann, Sophie K. Piper, Christian S. Kessler, Nico Steckhan, Andreas Michalsen, Friedemann Paul, Anja Mähler
Corticosteroid injection plus exercise versus exercise, beyond advice and a heel cup for patients with plantar fasciopathy: protocol for a randomised clinical superiority trial (the FIX-Heel trial)
Henrik Riel, Bill Vicenzino, Jens Lykkegaard Olesen, Martin Bach Jensen, Lars Holger Ehlers, Michael Skovdal Rathleff
Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) randomized controlled trial for children and young people
K. Khan, C. Hollis, C. L. Hall, E. B. Davies, D. Mataix-Cols, P. Andrén, T. Murphy, B. J. Brown, E. Murray, C. Glazebrook
Treatment of Middle East respiratory syndrome with a combination of lopinavir/ritonavir and interferon-β1b (MIRACLE trial): statistical analysis plan for a recursive two-stage group sequential randomized controlled trial
Yaseen M. Arabi, Ayed Y. Asiri, Abdullah M. Assiri, Hani A. Aziz Jokhdar, Adel Alothman, Hanan H. Balkhy, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Ziad A. Memish, Sameeh Ghazal, Sarah Al Faraj, Fahad Al-Hameed, Asim AlSaedi, Yasser Mandourah, Ghaleb A. Al Mekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Abdullah Almotairi, Ali Al Bshabshe, Ayman Kharaba, Jesna Jose, Abdulrahman Al Harthy, Mohammed Al Sulaiman, Ahmed Mady, Robert A. Fowler, Frederick G. Hayden, Abdulaziz Al-Dawood, Mohamed Abdelzaher, Wail Bajhmom, Mohamed A. Hussein
Behavioral Economics Incentives to Support HIV Treatment Adherence (BEST): Protocol for a randomized controlled trial in Uganda
Sebastian Linnemayr, Chad Stecher, Uzaib Saya, Sarah MacCarthy, Zachary Wagner, Larissa Jennings, Barbara Mukasa
Estimating dose-response for time to remission with instrumental variable adjustment: the obscuring effects of drug titration in Genome Based Therapeutic Drugs for Depression Trial (GENDEP): clinical trial data
Jennifer Hellier, Richard Emsley, Andrew Pickles
Danish Evaluation of Your Heart Forecast (DANY): study protocol for a cluster randomised controlled trial on an interactive risk-communication tool aimed at improving adherence of patients with high blood pressure
Anders Elkær Jensen, Jens Søndergaard, Niels Kristian Kjær, Rod Jackson, Jesper Bo Nielsen
Effects of sang-qi granules on blood pressure and endothelial dysfunction in stage I or II hypertension: study protocol for a randomized double-blind double-simulation controlled trial
Haoyue Shi, Deshuang Yang, Jiajun Qiao, Rui Sun, Ruihan Li, Chunlin Zhu, Ruiqing Jing, Liping Liu, Li Huang, Lin Li
Therapeutic drug monitoring of infliximab compared to standard clinical treatment with infliximab: study protocol for a randomised, controlled, open, parallel-group, phase IV study (the NOR-DRUM study)
Silje W Syversen, Guro L Goll, Kristin K Jørgensen, Inge C Olsen, Øystein Sandanger, Johanna E Gehin, David J Warren, Joseph Sexton, Cato Mørk, Jørgen Jahnsen, Tore K Kvien, Nils Bolstad, Espen A Haavardsholm
Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial
Fiona Gaughran, Dominic Stringer, Michael Berk, Shubulade Smith, David Taylor, Eromona Whiskey, Sabine Landau, Robin Murray, Philip McGuire, Poonam Gardner-Sood, Gabriella Wojewodka, Simone Ciufolini, Harriet Jordan, Jessie Clarke, Lauren Allen, Amir Krivoy, Brendon Stubbs, Philippa Lowe, Maurice Arbuthnott, Shanaya Rathod, Andrew Boardman, Mudasir Firdosi, John J. McGrath
Pharmacological conditioning in the treatment of recent-onset rheumatoid arthritis: a randomized controlled trial study protocol
Meriem Manaï, Henriët van Middendorp, Dieuwke S. Veldhuijzen, Joy A. van der Pol, Tom W. J. Huizinga, Andrea W. M. Evers
Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder
J. Santiago, E. Akeman, N. Kirlic, A. N. Clausen, K. T. Cosgrove, T. J. McDermott, B. Mathis, M. Paulus, M. G. Craske, J. Abelson, C. Martell, K. Wolitzky-Taylor, J. Bodurka, W. K. Thompson, Robin L. Aupperle
Tailored, psychological intervention for anxiety or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): protocol for a randomised controlled trial
Ratna Sohanpal, Hilary Pinnock, Liz Steed, Karen Heslop Marshall, Claire Chan, Moira Kelly, Stefan Priebe, C. Michael Roberts, Sally Singh, Melanie Smuk, Sarah Saqi-Waseem, Andy Healey, Martin Underwood, Patrick White, Chris Warburton, Stephanie J. C. Taylor
Blood biomarkers as surrogate endpoints of treatment responses to aerobic exercise and cognitive training (ACT) in amnestic mild cognitive impairment: the blood biomarkers study protocol of a randomized controlled trial (the ACT Trial)
Danni Li, Michelle M. Mielke, W. Robert Bell, Cavan Reilly, Lin Zhang, Feng Vankee Lin, Fang Yu
Metta-based group meditation and individual cognitive behavioral therapy (MeCBT) for chronic depression: study protocol for a randomized controlled trial
Artjom Frick, Isabel Thinnes, Ulrich Stangier
Comparing how patients value and respond to information on risk given in three different forms during dental check-ups: the PREFER randomised controlled trial
R. Harris, V. Lowers, L. Laverty, C. Vernazza, G. Burnside, S. Brown, L. Ternent
Effects of school-based physical activity and multi-micronutrient supplementation intervention on growth, health and well-being of schoolchildren in three African countries: the KaziAfya cluster randomised controlled trial protocol with a 2 × 2 factorial design
Markus Gerber, Serge A. Ayekoé, Johanna Beckmann, Bassirou Bonfoh, Jean T. Coulibaly, Dao Daouda, Rosa du Randt, Lina Finda, Stefanie Gall, Getrud J. Mollel, Christin Lang, Kurt Z. Long, Sebastian Ludyga, Honorati Masanja, Ivan Müller, Siphesihle Nqweniso, Fredros Okumu, Nicole Probst-Hensch, Uwe Pühse, Peter Steinmann, Sylvain G. Traoré, Cheryl Walter, Jürg Utzinger
Health Pregnancy, Healthy Baby: testing the added benefits of pregnancy ultrasound scan for child development in a randomised control trial
Linda Richter, Wiedaad Slemming, Shane A. Norris, Alan Stein, Lucilla Poston, Dharmintra Pasupathy
Effect and associated factors of a clinical pharmacy model in the incidence of medication errors (EACPharModel) in the Hospital Pablo Tobón Uribe: study protocol for a stepped wedge randomized controlled trial (NCT03338725)
J. Granados, A. Salazar-Ospina, J. P. Botero-Aguirre, A. F. Valencia-Quintero, N. Ortiz, P. Amariles
Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects, 1-year follow-up: a cluster-randomised trial
Allen Nsangi, Daniel Semakula, Andrew D. Oxman, Astrid Austvoll-Dahlgren, Matt Oxman, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Yunpeng Ding, Nelson K. Sewankambo
Exploring the recruitment, ethical considerations, conduct and information dissemination of an audiology trial: a pretrial qualitative study (q-COACH)
Emilie Francis-Auton, Chris Warren, Jeffrey Braithwaite, Frances Rapport
Acupuncture treatment on the motor area of the scalp for motor dysfunction in children with cerebral palsy: study protocol for a multicenter randomized controlled trial
Jun Wang, Wei Shi, Dhiaedin Khiati, Bingpei Shi, Xiaojuan Shi, Dandan Luo, Yin Wang, Rencai Deng, Huayu Huang, Jian Li, Weili Yan, Hong Yang
A call for consensus in defining efficacy in clinical trials for opioid addiction: combined results from a systematic review and qualitative study in patients receiving pharmacological assisted therapy for opioid use disorder
Brittany B. Dennis, Nitika Sanger, Monica Bawor, Leen Naji, Carolyn Plater, Andrew Worster, Julia Woo, Anuja Bhalerao, Natasha Baptist-Mohseni, Alannah Hillmer, Danielle Rice, Kim Corace, Brian Hutton, Peter Tugwell, Lehana Thabane, Zainab Samaan
Effects of lutein supplementation on inflammatory biomarkers and metabolic risk factors in adults with central obesity: study protocol for a randomised controlled study
Juan Zhou, Dan Zhao, Ning Wang, Zhiwei Zeng, Changyi Wang, Liping Hao, Xiaolin Peng
Trial Forge Guidance 2: how to decide if a further Study Within A Trial (SWAT) is needed
Shaun Treweek, Simon Bevan, Peter Bower, Matthias Briel, Marion Campbell, Jacquie Christie, Clive Collett, Seonaidh Cotton, Declan Devane, Adel El Feky, Sandra Galvin, Heidi Gardner, Katie Gillies, Kerenza Hood, Jan Jansen, Roberta Littleford, Adwoa Parker, Craig Ramsay, Lynne Restrup, Frank Sullivan, David Torgerson, Liz Tremain, Erik von Elm, Matthew Westmore, Hywel Williams, Paula R. Williamson, Mike Clarke
Global mapping of randomised trials related articles published in high-impact-factor medical journals: a cross-sectional analysis
Ferrán Catalá-López, Rafael Aleixandre-Benavent, Lisa Caulley, Brian Hutton, Rafael Tabarés-Seisdedos, David Moher, Adolfo Alonso-Arroyo
Efficacy and safety of two Ayurvedic dosage forms for allergic rhinitis: Study protocol for an open-label randomized controlled trial
Jeevani Maheshika Dahanayake, Pathirage Kamal Perera, Priyadarshani Galappaththy, Dulani Samaranayake
Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”
Mohua Maulik, Jyotsna Gupta, Atul Juneja, Tulsi Adhikari, Saurabh Sharma, Yashmin Panchal, Neha Yadav, Mendu Vishnu Vardhana Rao
Response to the Letter on: “An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry – India”
Mounika Pillamarapu, Abhilash Mohan, Gayatri Saberwal
The effects of if-then plans on weight loss: results of the 24-month follow-up of the McGill CHIP Healthy Weight Program randomized controlled trial
Bärbel Knäuper, Huma Shireen, Kimberly Carrière, Mallory Frayn, Elena Ivanova, Zhen Xu, Ilka Lowensteyn, Gentiana Sadikaj, Aleksandra Luszczynska, Steven Grover, Anaïs Ames-Bull, Shannon Caron, Melodie Chamandy, Farah Islam, Jenna Morris, Constanza Rosemary Lempereur de Saint Pierre, Julia Lévy-Ndejuru, Virginia Rogers, Anna Saint-Martin, Michelle Sasson, Anastasiya Voloshyn
Personalising psychotherapies for depression using a novel mixed methods approach: an example from Morita therapy
Holly Victoria Rose Sugg, Julia Frost, David A. Richards
Lessening Organ dysfunction with VITamin C (LOVIT): protocol for a randomized controlled trial
Marie-Hélène Masse, Julie Ménard, Sheila Sprague, Marie-Claude Battista, Deborah J. Cook, Gordon H. Guyatt, Daren K. Heyland, Salmaan Kanji, Ruxandra Pinto, Andrew G. Day, Dian Cohen, Djillali Annane, Shay McGuinness, Rachael Parke, Anitra Carr, Yaseen Arabi, Bharath Kumar Tirupakuzhi Vijayaraghavan, Frédérick D’Aragon, Élaine Carbonneau, David Maslove, Miranda Hunt, Bram Rochwerg, Tina Millen, Michaël Chassé, Martine Lebrasseur, Patrick Archambault, Estel Deblois, Christine Drouin, François Lellouche, Patricia Lizotte, Irene Watpool, Rebecca Porteous, France Clarke, Nicole Marinoff, Émilie Belley-Côté, Brigitte Bolduc, Scott Walker, John Iazzetta, Neill K. J. Adhikari, François Lamontagne
Early intervention for children at risk of visual processing dysfunctions from 1 year of age: a randomized controlled trial protocol
Marlou J. G. Kooiker, Yoni van der Linden, Jenneke van Dijk, Ymie J. van der Zee, Renate M. C. Swarte, Liesbeth S. Smit, Sanny van der Steen-Kant, Sjoukje E. Loudon, Irwin K. M. Reiss, Kees Kuyper, Johan J. M. Pel, Johannes van der Steen
Online-group intervention after suicide bereavement through the use of webinars: study protocol for a randomized controlled trial
Birgit Wagner, Laura Hofmann, Ulrike Maaß
Evaluating the effects of an exercise program (Staying UpRight) for older adults in long-term care on rates of falls: study protocol for a randomised controlled trial
Lynne Taylor, John Parsons, Denise Taylor, Elizabeth Binns, Sue Lord, Richard Edlin, Lynn Rochester, Silvia Del Din, Jochen Klenk, Christopher Buckley, Alana Cavadino, Simon A. Moyes, Ngaire Kerse
The PROMOTE study (High-protein and resistance-training combination in overweight and obesity) for short-term weight loss and long-term weight maintenance for Chinese people: a protocol for a pilot randomized controlled trial
Shaoyong Xu, Juan Zhang, Yuxiang Dong, Ruikun Chen, Wenlei Xu, Zhijun Tan, Ling Gao, Lei Shang
Measurement of cerebrovascular reserve by multimodal imaging for cerebral arterial occlusion or stenosis patients: protocol of a prospective, randomized, controlled clinical study
Zhi-peng Xiao, ke Jin, Jie-qing Wan, Yong Lin, Yao-hua Pan, Yi-chao Jin, Xiao-hua Zhang
Study protocol for a randomized controlled trial to evaluate a web-based comprehensive sexual health and media literacy education program for high school students
Tracy M. Scull, Christina V. Malik, Abigail Morrison, Elyse M. Keefe
Is there an interest in repeating the vaginal administration of dinoprostone (Propess®), to promote induction of labor of pregnant women at term? (RE-DINO): study protocol for a randomized controlled trial
P. Coste Mazeau, M. Hessas, R. Martin, J.-L. Eyraud, F. Margueritte, Y. Aubard, C. Sallee, F. Sire, T. Gauthier
Community youth teams facilitating participatory adolescent groups, youth leadership activities and livelihood promotion to improve school attendance, dietary diversity and mental health among adolescent girls in rural eastern India: protocol for a cluster-randomised controlled trial
Suchitra Rath, Audrey Prost, Subhashree Samal, Hemanta Pradhan, Andrew Copas, Sumitra Gagrai, Shibanand Rath, Raj Kumar Gope, Nirmala Nair, Prasanta Tripathy, Komal Bhatia, Kelly Rose-Clarke
Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: study protocol of a randomized controlled trial—the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study
Ximena Cid, David Canty, Alistair Royse, Andrea B. Maier, Douglas Johnson, Doa El-Ansary, Sandy Clarke-Errey, Timothy Fazio, Colin Royse
Optimization of the antibiotic management of diabetic foot infections: protocol for two randomized controlled trials
Felix Waibel, Martin Berli, Sabrina Catanzaro, Kati Sairanen, Madlaina Schöni, Thomas Böni, Jan Burkhard, Dominique Holy, Tanja Huber, Maik Bertram, Karin Läubli, Dario Frustaci, Andrea Rosskopf, Sander Botter, Ilker Uçkay
Evaluation of the effectiveness and tolerance of tetracosactide in the treatment of post-dural puncture headaches (ESYBRECHE): a study protocol for a randomised controlled trial
Célia Depaulis, Nadia Steer, Léa Garessus, Dominique Chassard, Frédéric Aubrun
Individualised stepwise adaptive treatment for 3–6-year-old preschool children impaired by attention-deficit/hyperactivity disorder (ESCApreschool): study protocol of an adaptive intervention study including two randomised controlled trials within the consortium ESCAlife
Katja Becker, Tobias Banaschewski, Daniel Brandeis, Christina Dose, Christopher Hautmann, Martin Holtmann, Thomas Jans, Lea Jendreizik, Carolin Jenkner, Katja John, Johanna Ketter, Sabina Millenet, Ursula Pauli-Pott, Tobias Renner, Marcel Romanos, Anne-Katrin Treier, Elena von Wirth, Anne-Kathrin Wermter, Manfred Döpfner
A brief transdiagnostic psychological intervention for Afghan asylum seekers and refugees in Austria: a randomized controlled trial
Matthias Knefel, Viktoria Kantor, Andrew A. Nicholson, Jennifer Schiess-Jokanovic, Dina Weindl, Ingo Schäfer, Brigitte Lueger-Schuster
Effect of temperature-control liner materials on long-term outcomes of lower limb prosthesis use: a randomized controlled trial protocol
Goeran Fiedler, Anita Singh, Xueyi Zhang
A prospective, randomized, single-blind, multicentre, phase III study on organ preservation with Custodiol-N solution compared with Custodiol® solution in organ transplantation (kidney, liver and pancreas)
Daniela Kniepeiss, Philipp Houben, Philipp Stiegler, Andrea Berghold, Regina Riedl, Judith Kahn, Peter Schemmer
Evaluation of the Teaching Recovery Techniques community-based intervention for unaccompanied refugee youth experiencing post-traumatic stress symptoms (Swedish UnaccomPanied yOuth Refugee Trial; SUPpORT): study protocol for a randomised controlled trial
Anna Sarkadi, Georgina Warner, Raziye Salari, Karin Fängström, Natalie Durbeej, Elin Lampa, Zaruhi Baghdasaryan, Fatumo Osman, Sandra Gupta Löfving, Anna Perez Aronsson, Inna Feldman, Filipa Sampaio, Richard Ssegonja, Rachel Calam, Anna Bjärtå, Anna Leiler, Elisabet Rondung, Elisabet Wasteson, Brit Oppedal, Brooks Keeshin
Implementing complaint-directed mini-interventions for depressive complaints in primary care to increase participation among patients with a lower socioeconomic status: design of a cluster randomised controlled trial
Stephanie S. Leone, Suzanne Lokman, Brigitte Boon, Agnes van der Poel, Filip Smit, Moniek Zijlstra-Vlasveld, Odile Smeets
The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments
Bethany M. Kwan, L. Miriam Dickinson, Russell E. Glasgow, Martha Sajatovic, Mark Gritz, Jodi Summers Holtrop, Don E. Nease Jr., Natalie Ritchie, Andrea Nederveld, Dennis Gurfinkel, Jeanette A. Waxmonsky
Study protocol of a randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity
Daniela Mercado, Jessica Werthmann, Iain C. Campbell, Ulrike Schmidt
Clinician–researchers and custodians of scarce resources: a qualitative study of health professionals’ views on barriers to the involvement of teenagers and young adults in cancer trials
Ruth I. Hart, Nina Hallowell, Jeni Harden, Angela B. Jesudason, Julia Lawton
A systematic review of the efficiency of recruitment to stroke rehabilitation randomised controlled trials
Kris McGill, Catherine M. Sackley, Jon Godwin, Jodie McGarry, Marian C. Brady
Acupuncture of fascia points to relieve hand spasm after stroke: a study protocol for a multicenter randomized controlled trial
Zeng-Qiao Zhang, Kun-Peng Li, Jing He, Li-Ming Jiang, Wu Wang, Xiao-Shen Hu, Wei Feng
Acute severe paediatric asthma: study protocol for the development of a core outcome set, a Pediatric Emergency Research Networks (PERN) study
Simon Craig, Franz E. Babl, Stuart R. Dalziel, Charmaine Gray, Colin Powell, Khalid Al Ansari, Mark D. Lyttle, Damian Roland, Javier Benito, Roberto Velasco, Julia Hoeffe, Diana Moldovan, Graham Thompson, Suzanne Schuh, Joseph J. Zorc, Maria Kwok, Prashant Mahajan, Michael D. Johnson, Robert Sapien, Kajal Khanna, Pedro Rino, Javier Prego, Adriana Yock, Ricardo M. Fernandes, Indumathy Santhanam, Baljit Cheema, Gene Ong, Shu-Ling Chong, Andis Graudins, Nathan Kupperman, Stuart Dalziel, Franz Babl, Jim Chamberlain, David Johnson, Mark Lyttle, Santiago Mintegi, Rakesh Mistry, Lise Nigrovic, Amy Plint, Damian Roland, Patrick Van de Van de Voorde
Study protocol for a randomized controlled trial on the effect of the Diabetic Foot Guidance System (SOPeD) for the prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial I
J. S. S. P. Ferreira, R. H. Cruvinel Junior, E. Q. Silva, J. L. Veríssimo, R. L. Monteiro, D. S. Pereira, E. Y. Suda, C. D. Sartor, I. C. N. Sacco
Swiss chocolate and free beverages to increase the motivation for scientific work amongst residents: a prospective interventional study in a non-academic teaching hospital in Switzerland
Annika Rühle, Florian Oehme, Björn-Christian Link, Jürg Metzger, Henning Fischer, Michael Stickel, Dimitri E. Delagrammaticas, Reto Babst, Frank J. P. Beeres
Efficacy and safety of Guhong injection for treating coronary microvascular disease: study protocol for a randomized controlled trial
Zhuang Jieqin, Liu Shuling, Cai Hairong, Dai Xingzhen, Chen Yanhong, Jin Zilin, Chen Bojun
Efficacy of compatible acupoints and single acupoint versus sham acupuncture for functional dyspepsia: study protocol for a randomized controlled trial
Le Guo, Xin Huang, Li-Juan Ha, Jing-Zhou Zhang, Jia Mi, Ping-Hui Sun, Xi-Ying Han, Ying Wang, Jing-Lin Hu, Fu-Chun Wang, Tie Li
Double-chamber syringe versus classic syringes for peripheral intravenous drug administration and catheter flushing: a study protocol for a randomised controlled trial
Pedro Parreira, Liliana B. Sousa, Inês A. Marques, Paulo Santos-Costa, Luciene M. Braga, Arménio Cruz, Anabela Salgueiro-Oliveira
KARAOKE: Krill oil versus placebo in the treatment of knee osteoarthritis: protocol for a randomised controlled trial
L. L. Laslett, B. Antony, A. E. Wluka, C. Hill, L. March, H. I. Keen, P. Otahal, F. M. Cicuttini, G. Jones
Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebo-controlled, randomised, double blind, multi-centre study
Frank Tegtmeier, Reinhard Schinzel, Ronny Beer, Diederik Bulters, Jean-Yves LeFrant, Joan Sahuquillo, Andreas Unterberg, Peter Andrews, Antonio Belli, Javier Ibanez, Alfonso Lagares, Michael Mokry, Harald Willschke, Charlotte Flüh, Erich Schmutzhard
Virtual Reality Social Prediction Improvement and Rehabilitation Intensive Training (VR-SPIRIT) for paediatric patients with congenital cerebellar diseases: study protocol of a randomised controlled trial
Niccolò Butti, Emilia Biffi, Chiara Genova, Romina Romaniello, Davide Felice Redaelli, Gianluigi Reni, Renato Borgatti, Cosimo Urgesi
Bayesian group sequential designs for phase III emergency medicine trials: a case study using the PARAMEDIC2 trial
Elizabeth G. Ryan, Nigel Stallard, Ranjit Lall, Chen Ji, Gavin D. Perkins, Simon Gates
A study protocol for a randomised trial of adjunct computerised memory specificity training (c-MeST) for major depression in youth: targeting cognitive mechanisms to enhance usual care outcomes in mental health settings
D. J. Hallford, A. M. Carmichael, D. W. Austin, K. Takano, F. Raes, M. Fuller-Tyszkiewicz
Evaluating a digital tool for supporting breast cancer patients: a randomized controlled trial protocol (ADAPT)
Emma Lidington, Sophie E McGrath, Jillian Noble, Susannah Stanway, Amanda Lucas, Kabir Mohammed, Winette van der Graaf, Olga Husson
High-frequency spinal cord stimulation at 10 kHz for the treatment of painful diabetic neuropathy: design of a multicenter, randomized controlled trial (SENZA-PDN)
Nagy A. Mekhail, Charles E. Argoff, Rod S. Taylor, Christian Nasr, David L. Caraway, Bradford E. Gliner, Jeyakumar Subbaroyan, Elizabeth S. Brooks
The cost-effectiveness of specialized nursing interventions for people with Parkinson’s disease: the NICE-PD study protocol for a randomized controlled clinical trial
Danique L. M. Radder, Herma H. Lennaerts, Hester Vermeulen, Thies van Asseldonk, Cathérine C. S. Delnooz, Rob H. Hagen, Marten Munneke, Bastiaan R. Bloem, Nienke M. de Vries
CApecitabine plus Radium-223 (Xofigo™) in breast cancer patients with BONe metastases (CARBON): study protocol for a phase IB/IIA randomised controlled trial
Rob Coleman, Janet Brown, Emma Rathbone, Louise Flanagan, Amber Reid, Jessica Kendall, Sacha Howell, Chris Twelves, Carlo Palmieri, Anjana Anand, Iain MacPherson, Sarah Brown
Dose reduction and withdrawal strategy for TNF-inhibitors in psoriatic arthritis and axial spondyloarthritis: design of a pragmatic open-label, randomised, non-inferiority trial
Celia A. J. Michielsens, Nadine Boers, Nathan den Broeder, Mark H. Wenink, Aatke van der Maas, Elien A. M. Mahler, Michelle L. M. Mulder, Désirée van der Heijde, Frank H. J. van den Hoogen, Lise M. Verhoef, Alfons A. den Broeder
Moderators of the effectiveness of an intervention to increase colorectal cancer screening through mailed fecal immunochemical test kits: results from a pragmatic randomized trial
Elizabeth A. O’Connor, William M. Vollmer, Amanda F. Petrik, Beverly B. Green, Gloria D. Coronado
A pilot randomized controlled trial of 7 versus 14 days of antibiotic treatment for bloodstream infection on non-intensive care versus intensive care wards
Nick Daneman, Asgar H. Rishu, Ruxandra Pinto, Yaseen Arabi, Emilie P. Belley-Cote, Robert Cirone, Mark Downing, Deborah J. Cook, Richard Hall, Shay McGuinness, Lauralyn McIntyre, John Muscedere, Rachael Parke, Steven Reynolds, Benjamin A. Rogers, Yahya Shehabi, Phillip Shin, Richard Whitlock, Robert A. Fowler
Impact of omega-3 fatty acid oral therapy on healing of chronic venous leg ulcers in older adults: Study protocol for a randomized controlled single-center trial
Jodi C. McDaniel, Jamie Rausch, Alai Tan
Efficacy and safety of Jianpishengsui for chemotherapy-related fatigue in patients with non-small cell lung cancer: study protocol for a randomized placebo-controlled clinical trial
Zhiwei Xiao, Leihao Hu, Jietao Lin, Liming Lu, Xuewu Huang, Xiaoshu Zhu, Chiahshean Teo, Lizhu Lin
A study protocol for a randomized controlled trial evaluating vibration therapy as an intervention for postural training and fall prevention after distal radius fracture in elderly patients
Ronald Man Yeung WONG, Wing-Tung HO, Ning TANG, Chi Yin TSO, Wai Kit Raymond Ng, Simon Kwoon-Ho CHOW, Wing-Hoi CHEUNG
International randomised controlled trial for the treatment of newly diagnosed EWING sarcoma family of tumours – EURO EWING 2012 Protocol
Jennifer Anderton, Veronica Moroz, Perrine Marec-Bérard, Nathalie Gaspar, Valerie Laurence, Javier Martín-Broto, Ana Sastre, Hans Gelderblom, Cormac Owens, Sophie Kaiser, Melissa Fernández-Pinto, Nicola Fenwick, Abigail Evans, Sandra Strauss, Jeremy Whelan, Keith Wheatley, Bernadette Brennan
Testing non-inferiority of blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis and the effectiveness of blended booster sessions aimed at improving long-term outcome following both therapies: study protocol for two observer-blinded randomized clinical trials
Marieke Houniet-de Gier, Heleen Beckerman, Kimberley van Vliet, Hans Knoop, Vincent de Groot
A prospective randomized controlled study of auricular point acupressure to manage chronic low back pain in older adults: study protocol
Chao Hsing Yeh, Cuicui Li, Ronald Glick, Elizabeth A. Schlenk, Kathryn Albers, Lorna Kwai-Ping Suen, Nada Lukkahatai, Nicole Salen, Sonaali Pandiri, Weixia Ma, Nancy Perrin, Natalia E. Morone, Paul J. Christo
Comparison of the effectiveness of a tailored cognitive behavioural therapy with a supportive listening intervention for depression in those newly diagnosed with multiple sclerosis (the ACTION-MS trial): protocol of an assessor-blinded, active comparator, randomised controlled trial
Litza Kiropoulos, Trevor Kilpatrick, Tomas Kalincek, Leonid Cherulov, Elizabeth McDonald, Tissa Wijeratne, Jennifer Threader, Vanja Rozenblat, Neil Simpson-O’Brien, Anneke Van Der Walt, Lisa Taylor
Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study
Christine M. Bond, Richard Holland, David P. Alldred, Antony Arthur, Garry Barton, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris, Fiona M. Poland, Lee Shepstone, David Turner, Arnold Zermansky, David Wright
Letter on “Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK”
Sarah Griffiths, Lorna Manger, Rebecca Chapman, Lauren Weston, Ian Sherriff, Cath Quinn, Paul Clarkson, Caroline Sutcliffe, Karen Davies, Richard Byng
Cross-sectoral rehabilitation intervention for patients with intermittent claudication versus usual care for patients in non-operative management - the CIPIC Rehab Study: study protocol for a randomised controlled trial
Maj Siercke, Lise Pyndt Jørgensen, Malene Missel, Lau Caspar Thygesen, Pernille Peppercorn Blach, Henrik Sillesen, Selina Kikkenborg Berg
The efficacy and safety of 'antianxiety granule' for anxiety disorder: a multicentre, randomized, double-blind, placebo-controlled, parallel-group trial
Zhongwei Sha, Yiping Hou, Chunchun Xue, Ou Li, Zhimin Li, Huiru Wang, Wenjing Zhang, Jian Xu
Improving risk perception and uptake of voluntary medical male circumcision with peer-education sessions and incentives, in Manicaland, East Zimbabwe: study protocol for a pilot randomised trial
Ranjeeta Thomas, Morten Skovdal, Matteo M. Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B. Hallett, Simon Gregson
Point OutWords: protocol for a feasibility randomised controlled trial of a motor skills intervention to promote communicative development in non-verbal children with autism
Ailbhe McKinney, Kathryn L. Hotson, Alicia Rybicki, Emma J. L. Weisblatt, Claudia Días, Juliet Foster, Sofía S. Villar, Suzanne Murphy, Matthew K. Belmonte
Efficacy of acupuncture at three nasal acupoints plus acupoint application for perennial allergic rhinitis: A multicenter, randomized controlled trial protocol
Yin Shou, Li Hu, Cuihong Zhang, Shifen Xu, Qi Jin, Li Huang, Bingrong Li, Long Yuan, Siwei Xu, Kaiyong Zhang, Huiru Jiang, Bimeng Zhang
Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol
Adnan Al-Kaisy, Jonathan Royds, Stefano Palmisani, David Pang, Samuel Wesley, Rod S. Taylor, Andrew Cook, Sam Eldabe, Lance McCracken, Rui Duarte, Jeremy Fairbank
Pelvic floor rehabilitation to improve functional outcome and quality of life after surgery for rectal cancer: study protocol for a randomized controlled trial (FORCE trial)
A.J. Kalkdijk-Dijkstra, J.A.G. van der Heijden, H.L. van Westreenen, P.M.A. Broens, M. Trzpis, J.P.E.N. Pierie, B.R. Klarenbeek, M. W. J. Stommel, J. H. W. de Wilt, A. J. A. Bremers, C. Rosman, P. R. de Reuver, S. A. W. Bouwense, B. M. van der Kolk, L. M. Garms, K. Meerten-van den Belt, M. R. M. Olde Hartman-Hofsté, J. W. M. Peters, L. Olsder, I. Huizing, E. J. B. Furnée, K. Havenga, P. H. J. Hemmer, B. van Etten, A. Koop, L. van der Heide, D. Kamphuis, S. A. Koopal, C. Hoff, H. Eker, H. H. M. Junte, I. J. H. Schoenaker, S. Quaedackers, M. J. Bos, H. Gardien, T. C. van Sprundel, P. D. de Vries, J. F. Ashruf, L. Geurts, I. Nielen, J. Pfeil, M. van Ark, S. W. Polle, B. Hansson, F. Polat, H. de Vries, E. ten Berge-Groen, A. K. Talsma, R. Bosker, E. Veurink, M. Papa, A. J. G. Maaskant-Braat, F. J. C. van den Broek, W. K. G. Leclercq, G. D. Slooter, F. Caers, M. Boeijen, R. van den Broek, K. van Schaik, D. K. Wasowicz-Kemps, B. S. Langenhoff, M. J. van den Bogaard, J. van der Sluis, D. Arisz, S. Bruinsma, D. A. Hess, E. J. Mulder, B. Wiering, S. Kok, J. Woltering, B. Raap-van Sleuwen, L. Schoonderwoerd, D. Hendriks, N. van den Elzen, I. van de Laak, M. Valk, W. van der Meij, B. J. van Wely, M. J. van Hoogstraten, M. van der Sluis, I. Paulusma, M. J. W. Möllers, R. Looijen, H. C. J. van der Mijle, I. T. A. Pereboom, P. M. C. Tijink-Callenbach, R. A. Schasfoort, W. van de Meer, M. Lubberink, M. van Haskera, F. Wit, M. Jeeninga, R. ten Hoeve, F. C. W. Slootmans, B. Inberg, L. de Nes, Dianne Toonen, M. A. Wilmsen, O. Buyne, F. Ferenschild, C. Adamse, B. L. Hettema-Beets, M. K. Goudswaard, M. van der Velde, D. W. Elving, R. E. Arends-Smit, J. R. Buiter, I. van der Witte-van Aerle, K. Jansma, L. Kooistra, S. Lohof-Venema, M. R. Kruijer, G. Dijkstra, M. A. van der Werf-Elling, V. Kats-de Boer, A. M. Rinsema, M. Haarlemmer - Lutjeboer, A. Van der Vegt, S. M. H. Berends-Pors, A. J. Ponstein, G. Klaassen, A. M. Nieuwint, M. Veninga-Jansen, V. Dries-Jansen, F. J. Arends, N. E. Stellingwerf-Goinga, N. W. G. Overmars, H. Van Asma, K. Beverdam, M. J. A. C. Ploumen, M. Tijhuis, A. H. Visser Duiven, M. Former, M. A. L. Smans-Kaal, C. M. J. Vorsterman van Oijen-Linthorst, N. N. Hövels-Kamp, L. R. Vorsteveld, N. Vermeulen, A. Alkemade- van Veghel, L. J. W. Steentjes, H. G. M. Cornelisse-Theunissen, J. Strijbosch, S. Sniekers, J. M. A. Oerlemans-van Oijen, H. M. J. Hoefnagels, C. J. D. A. Sniekers, S. Biemans, Y. Bomert-Wendt, H. G. M. van Gaal, A. H. C. W. Smulders, W. Adams, J. M. Kappen, A. M. Vermeltfoort-Jansen, M. G. C. Zegger, C. Vrielink, H. M. Slotman, N. J. H. Claessens, A. W. M. Manders-de Groot, C. T. P. G. van Beuzekom- van der Vorst, M. W. C. Swinkels- Nijssen, P. van Oeveren, J. P. F. van Leeuwen-Nellestijn, M. Bleijenberg, J. J. F. Valenteyn-Hidden, M. G. van Rutten-de Groot, M. van den Nieuwenhuizen, P. G. Boorsma, N. Broodman, M. E. Elling, E. Bokkers-Engelen, G. H. Hilhorst-Droppers, H. J. C. Mein
Clinical evaluation of ultrasonic subgingival debridement versus ultrasonic subgingival scaling combined with manual root planing in the treatment of periodontitis: study protocol for a randomized controlled trial
Yue Yan, Yalin Zhan, Xian’e Wang, Jianxia Hou
Does a mindfulness-augmented version of the German Strengthening Families Program reduce substance use in adolescents? Study protocol for a randomized controlled trial
Nicolas Arnaud, Christiane Baldus, Léa Josette Laurenz, Sonja Bröning, Maja Brandt, Sabrina Kunze, Maria Austermann, Linda Zimmermann, Anne Daubmann, Rainer Thomasius, Frauke Nees, Maren Prignitz, Stella Guldner, Herta Flor, Peter-Michael Sack, Karl Wegscheider, Antonia Zapf, Petra Meibert, Johannes Michalak, Virginia Molgaard, Kathy Hockaday, Lindsey Coombs
Streamlining and cycle time reduction of the startup phase of clinical trials
Amani Abu-Shaheen, Ahmad Al Badr, Isamme Al Fayyad, Adel Al Qutub, Eissa Ali Faqeih, Mohamad Al-Tannir
Challenges in the design, planning and implementation of trials evaluating group interventions
Katie Biggs, Daniel Hind, Rebecca Gossage-Worrall, Kirsty Sprange, David White, Jessica Wright, Robin Chatters, Katherine Berry, Diana Papaioannou, Mike Bradburn, Stephen J. Walters, Cindy Cooper
Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors
Franziska Holtdirk, Anja Mehnert, Mario Weiss, Björn Meyer, Carsten Watzl
Efficacy and safety of Ojeok-san plus Saengmaek-san for gastroesophageal reflux-induced chronic cough: protocol for a pilot, randomized, double-blind, placebo-controlled trial
Yeon Hee Bhang, Kwan-Il Kim, Jaehyo Kim, Junmo Ahn, Hwan-Su Jung, Changsop Yang, Seok-Jae Ko, Youngmin Bu, Jae-Woo Park, Kyoung Sun Park, Hee-Jae Jung, Jun-Hwan Lee, Beom-Joon Lee
An integrated intervention for chronic care management in rural Nepal: protocol of a type 2 hybrid effectiveness-implementation study
Dan Schwarz, Santosh Dhungana, Anirudh Kumar, Bibhav Acharya, Pawan Agrawal, Anu Aryal, Aaron Baum, Nandini Choudhury, David Citrin, Binod Dangal, Meghnath Dhimal, Bikash Gauchan, Tula Gupta, Scott Halliday, Biraj Karmacharya, Sandeep Kishore, Bhagawan Koirala, Uday Kshatriya, Erica Levine, Sheela Maru, Pragya Rimal, Sabitri Sapkota, Ryan Schwarz, Archana Shrestha, Aradhana Thapa, Duncan Maru
Aspirin for metal stent in malignant distal common bile duct obstruction (AIMS): study protocol for a multicenter randomized controlled trial
Jin Ho Choi, Woo Hyun Paik, Min Su You, Kyong Joo Lee, Young Hoon Choi, Bang-sup Shin, Sang Hyub Lee, Ji Kon Ryu, Yong-Tae Kim
Early universal use of oral progesterone for prevention of preterm births in singleton pregnancy (SINPRO study): protocol of a multicenter, randomized, double-blind, placebo-controlled trial
Ka Wang Cheung, Mimi Tin Yan Seto, Ernest Hung Yu Ng
Randomised, double-blind, placebo controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults
Anu Kemppinen, Carol Howell, Victoria Allgar, Matthew Dodd, John Gregson, Charles Knowles, John McLaughlin, Preeti Pandya, Peter Whorwell, Elena Markaryan, Yan Yiannakou
Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE) – Study protocol from a randomized controlled trial
Josefin Sundh, Anders Magnuson, Scott Montgomery, Pontus Andell, Gustaf Rindler, Ole Fröbert, Malgorzata Przybyszewska, Anders Blomberg, Magnus Widmark, Andreas Palm, Wolfgang Greger, Jens Ellingsen, Lennart Råhlén, Taivo Kipper, Mikael Hasselgren, Carolina Smith, Florim Delijaj, Kaj Possler, Johanna Nilsson, Niklas Stenersen, Han Nguyen, Dan Curiac, Lowie E. G. W. Vanfleteren, Lars Johansson, Folke Sjöberg, Magnus Ekström, Johan Sanmartin Berglund, Anders Lökke
Efficacy and cost-utility of the eHealth self-management application 'Oncokompas', helping partners of patients with incurable cancer to identify their unmet supportive care needs and to take actions to meet their needs: a study protocol of a randomized controlled trial
Anouk S. Schuit, Karen Holtmaat, Nienke Hooghiemstra, Femke Jansen, Birgit I. Lissenberg-Witte, Veerle M. H. Coupé, Irma M. Verdonck-de Leeuw
Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial)
Xian Wu, Yunqiu Xia, Ou Zhou, Yan Song, Xianhong Zhang, Daiyin Tian, Qubei Li, Chang Shu, Enmei Liu, Xiaoping Yuan, Ling He, Chengjun Liu, Jing Li, Xiaohua Liang, Ke Yang, Zhou Fu, Lin Zou, Lei Bao, Jihong Dai
Operationalising kangaroo Mother care before stabilisation amongst low birth Weight Neonates in Africa (OMWaNA): protocol for a randomised controlled trial to examine mortality impact in Uganda
Melissa M. Medvedev, Victor Tumukunde, Ivan Mambule, Cally J. Tann, Peter Waiswa, Ruth R. Canter, Christian H. Hansen, Elizabeth Ekirapa-Kiracho, Kenneth Katumba, Catherine Pitt, Giulia Greco, Helen Brotherton, Diana Elbourne, Janet Seeley, Moffat Nyirenda, Elizabeth Allen, Joy E. Lawn
Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India
Sunita Taneja, Ranadip Chowdhury, Neeta Dhabhai, Sarmila Mazumder, Ravi Prakash Upadhyay, Sitanshi Sharma, Rupali Dewan, Pratima Mittal, Harish Chellani, Rajiv Bahl, Maharaj Kishan Bhan, Nita Bhandari, Farhana Rafiqui, Jasmine Kaur, Gunjan Aggarwal, Nikita Arya, Anita Kate, Medha Shekhar, Shruti Verma, Ratan Shekhawat, Neelam Kaur, Richa Chauhan, Kaavya Singh, Geeta Mehto, Runa Ghosh, Neha Tyagi, Payal Chakraborty, Ramanjit Kaur, Kunal Kishore, Navneet Mehra, Anuradha Tamaria, Ritu Chaudhary, Aparna Singh, Priyanka Singh, Dolly Jain, Gulafshan Ansari, Tivendra Kumar, Savita Sapra, Afifa Khatun, Kiran Bhatia, Manisha Gupta, Girish Chand Pant, Tarun Shankar Choudhary, Ankita Dutta, Deepak More, K. C. Aggarwal, Sujata Das, Pradeep Debata, Anita Yadav, Reeta Bansiwal, Abhinav Jain, Nitika
Effect of Daesiho-tang on obesity with non-alcoholic fatty liver disease: a study protocol for a randomised, double-blind, placebo-controlled pilot trial
Kyungsun Han, Ojin Kwon, Hyo-ju Park, So-Young Jung, Changsop Yang, Chang-Gue Son
Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I)
Henrik Fox, Andrea Hetzenecker, Stefan Stadler, Olaf Oldenburg, Okka W. Hamer, Florian Zeman, Leonhard Bruch, Mirko Seidel, Stefan Buchner, Michael Arzt
Model-based PEEP titration versus standard practice in mechanical ventilation: a randomised controlled trial
Kyeong Tae Kim, Sophie Morton, Sarah Howe, Yeong Shiong Chiew, Jennifer L. Knopp, Paul Docherty, Christopher Pretty, Thomas Desaive, Balazs Benyo, Akos Szlavecz, Knut Moeller, Geoffrey M. Shaw, J. Geoffrey Chase
Statistical analysis plan for the randomized controlled trial CardioCare MV investigating a novel integrated care concept (NICC) for patients suffering from chronic cardiovascular disease
Andreas Ziegler, Miriam Mann, Bernard Brandewiede, Hermann Dittrich, Sissy Hintz, Katja Krockenberger, Alper Öner, Marcos Oliviera de Sousa, Christian Schmidt
Aim2Be mHealth intervention for children with overweight and obesity: study protocol for a randomized controlled trial
Louise C. Mâsse, Janae Vlaar, Janice Macdonald, Jennifer Bradbury, Tom Warshawski, E. Jean Buckler, Jill Hamilton, Josephine Ho, Annick Buchholz, Katherine M. Morrison, Geoff D. C. Ball
Doll therapy intervention for women with dementia living in nursing homes: a randomized single-blind controlled trial protocol
Roberta Vaccaro, Roberta Ballabio, Valentina Molteni, Laura Ceppi, Benedetta Ferrari, Marco Cantù, Daniele Zaccaria, Carla Vandoni, Rita Bianca Ardito, Mauro Adenzato, Barbara Poletti, Antonio Guaita, Rita Pezzati
Financial incentives for hypertension control: rationale and study design
Liqiang Zheng, Yali Wang, Sitong Liu, Rui Zheng, Dongmei Pei, Yingxian Sun, Zhaoqing Sun
Intratympanic versus intravenous corticosteroid treatment for sudden sensorineural hearing loss in diabetic patients: proposed study protocol for a prospective, randomized superiority trial
Weiqiang Yang, Xiaoling Li, Jiatao Zhong, Xueshuang Mei, Hongyu Liu, Le Yang, Liming Lu, Hongyi Hu
Randomized Efficacy and Safety Trial with Oral S 44819 after Recent ischemic cerebral Event (RESTORE BRAIN study): a placebo controlled phase II study
Hugues Chabriat, Claudio L. Bassetti, Ute Marx, Françoise Picarel-Blanchot, Aurore Sors, Celine Gruget, Barbara Saba, Marine Wattez, Marie-Laure Audoli, Dirk M. Hermann
Prevention of doxorubicin-induced Cardiotoxicity by pharmacological non-hypoxic myocardial preconditioning based on Docosahexaenoic Acid (DHA) and carvedilol direct antioxidant effects: study protocol for a pilot, randomized, double-blind, controlled trial (CarDHA trial)
Rodrigo Carrasco, María Cristina Ramirez, Kjersti Nes, Andrés Schuster, Rubén Aguayo, Marcelo Morales, Cristobal Ramos, Daniel Hasson, Camilo G. Sotomayor, Pablo Henriquez, Ignacio Cortés, Marcia Erazo, Claudio Salas, Juan G. Gormaz
Intravenous versus subcutaneous route pharmacokinetics of paracetamol (acetaminophen) in palliative care patients: study protocol for a randomized trial (ParaSCIVPallia)
Marine Vernant, Marie Lepoupet, Christian Creveuil, Antoine Alix, Charlotte Gourio, Laure Peyro-Saint-Paul, Veronique Lelong-Boulouard, Cyril Guillaumé
Rugby Fans in Training New Zealand (RUFIT-NZ): protocol for a randomized controlled trial to assess the effectiveness and cost-effectiveness of a healthy lifestyle program for overweight men delivered through professional rugby clubs in New Zealand
Ralph Maddison, Elaine Anne Hargreaves, Yannan Jiang, Amanda Jane Calder, Sally Wyke, Cindy M. Gray, Kate Hunt, David Lubans, Helen Eyles, Nick Draper, Ihirangi Heke, Stephen Kara, Gerhard Sundborn, Claire Arandjus, Matthew Jenkins, Samantha Marsh
Preventing early childhood caries with silver diamine fluoride: study protocol for a randomised clinical trial
Sherry Shiqian Gao, Kitty Jieyi Chen, Duangporn Duangthip, May Chun Mei Wong, Edward Chin Man Lo, Chun Hung Chu
Intra-arterial versus standard intravenous administration of lutetium-177-DOTA-octreotate in patients with NET liver metastases: study protocol for a multicenter, randomized controlled trial (LUTIA trial)
Sander C. Ebbers, Arthur J. A. T. Braat, Adriaan Moelker, Marcel P. M. Stokkel, Marnix G. E. H. Lam, Maarten W. Barentsz
Anterior quadratus lumborum block for postoperative recovery after total hip arthroplasty: a study protocol for a single-center, double-blind, randomized controlled trial
Masaru Kikuchi, Takahiro Mihara, Yusuke Mizuno, Hiroko Fujimoto, Sachiko Arai, Takeshi Nomura, Takahisa Goto
Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial
Yunxuan Huang, Jiabi Zhang, Buhui Xiong, Ruina Huang, Wenjing Zhao, Mengxue Zhou, Qi Chen, Danghan Xu, Xinghua Chen
Short postsurgical antibiotic therapy for spinal infections: protocol of prospective, randomized, unblinded, noninferiority trials (SASI trials)
Michael Betz, Ilker Uçkay, Regula Schüpbach, Tanja Gröber, Sander M. Botter, Jan Burkhard, Dominique Holy, Yvonne Achermann, Mazda Farshad
Handling an uncertain control group event risk in non-inferiority trials: non-inferiority frontiers and the power-stabilising transformation
Matteo Quartagno, A. Sarah Walker, Abdel G. Babiker, Rebecca M. Turner, Mahesh K. B. Parmar, Andrew Copas, Ian R. White
Protocol for a randomised controlled trial of a co-produced, complex, health promotion intervention for women with prior gestational diabetes and their families: the Face-it study
Karoline Kragelund Nielsen, Inger Katrine Dahl-Petersen, Dorte Møller Jensen, Per Ovesen, Peter Damm, Nanna Husted Jensen, Maja Thøgersen, Anne Timm, Line Hillersdal, Ulla Kampmann, Christina Anne Vinter, Elisabeth Reinhardt Mathiesen, Helle Terkildsen Maindal
To continue or not to continue? Antipsychotic medication maintenance versus dose-reduction/discontinuation in first episode psychosis: HAMLETT, a pragmatic multicenter single-blind randomized controlled trial
Marieke J. H. Begemann, Ilse A. Thompson, Wim Veling, Shiral S. Gangadin, Chris N. W. Geraets, Erna van ‘t Hag, Sanne J. Müller-Kuperus, Priscilla P. Oomen, Alban E. Voppel, Mark van der Gaag, Martijn J. Kikkert, Jim Van Os, H. Filip E. Smit, Rikus H. Knegtering, Sybren Wiersma, Luyken H. Stouten, Harm J. Gijsman, Lex Wunderink, Anton B. P. Staring, Selene R. T. Veerman, Amrita G. S. Mahabir, Jörg Kurkamp, Gerdina H. M. Pijnenborg, Natalie D. Veen, Machteld Marcelis, Koen P. Grootens, Gunnar Faber, Nico J. van Beveren, Agaath Been, Truus van den Brink, Maarten Bak, Therese A. M. J. van Amelsvoort, Andrea Ruissen, Christine Blanke, Karin Groen, Lieuwe de Haan, Iris E. C. Sommer
The mixed model for repeated measures for cluster randomized trials: a simulation study investigating bias and type I error with missing continuous data
Melanie L. Bell, Brooke A. Rabe
The effects of protective lung ventilation on regional cerebral oxygen saturation in intracranial tumor operation during dura opening: study protocol for a randomized controlled trial
Jinlu Li, Xuemei Wu, Hairui Liu, Ying Huang, Yueqin Liu, Hong Xie, Jun Dong
Online randomized controlled experiments at scale: lessons and extensions to medicine
Ron Kohavi, Diane Tang, Ya Xu, Lars G. Hemkens, John P. A. Ioannidis
Effectiveness of Checklist-Based Box System Interventions (CBBSI) versus routine care on improving utilization of maternal health services in Northwest Ethiopia: study protocol for a cluster randomized controlled trial
Netsanet Belete Andargie, Mulusew Gerbaba Jebena, Gurmesa Tura Debelew
Impact of a paediatric-adult care transition programme on the health status of patients with sickle cell disease: study protocol for a randomised controlled trial (the DREPADO trial)
Delphine Hoegy, Nathalie Bleyzac, Alexandra Gauthier-Vasserot, Giovanna Cannas, Angélique Denis, Arnaud Hot, Yves Bertrand, Pauline Occelli, Sandrine Touzet, Claude Dussart, Audrey Janoly-Dumenil, C. Pivot, C. Pondarre, F. Galactéros, E. Fois, M. De Montalembert, J. B. Arlet, G. Elana, K. Michaux, C. Guitton, C. Chantalat, S. Eyssette-Guerreau, L. Blum
Emotion regulation training in the treatment of obesity in young adolescents: protocol for a randomized controlled trial
Taaike Debeuf, Sandra Verbeken, Elisa Boelens, Brenda Volkaert, Eva Van Malderen, Nathalie Michels, Caroline Braet
Sinako, a study on HIV competent households in South Africa: a cluster-randomised controlled trial protocol
Caroline Masquillier, Lucia Knight, Linda Campbell, Neo Sematlane, Anton Delport, Tanyaradzwa Dube, Edwin Wouters
Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis: protocol of a randomized, placebo-controlled, double-blind clinical trial (COMPLETE-PsA)
Michelle L. M. Mulder, Johanna E. Vriezekolk, Nathan den Broeder, Elien A. M. Mahler, Philip S. Helliwell, Frank H. J. van den Hoogen, Alfons A. den Broeder, Mark H. Wenink
Machine learning analysis plans for randomised controlled trials: detecting treatment effect heterogeneity with strict control of type I error
James A. Watson, Chris C. Holmes
A randomised, double-blind, active placebo-controlled, parallel groups, dose-response study of scopolamine hydrobromide (4–6 μg/kg) in patients with major depressive disorder
Joseph C. C. Chen, Rachael L. Sumner, Venkat Krishnamurthy Naga, Nicholas Hoeh, Hafis Adetokunbo Ayeni, Vikrant Singh, Frederick Sundram, Douglas Campbell, Suresh Muthukumaraswamy
A randomised placebo controlled trial of anakinra for treating pustular psoriasis: statistical analysis plan for stage two of the APRICOT trial
Suzie Cro, Prakash Patel, Jonathan Barker, David A. Burden, Christopher E. M. Griffiths, Helen J. Lachmann, Nick J. Reynolds, Richard B. Warren, Francesca Capon, Catherine Smith, Victoria Cornelius
Comparison of two techniques used in routine care for the treatment of inflammatory macular oedema, subconjunctival triamcinolone injection and intravitreal dexamethasone implant: medical and economic importance of this randomized controlled trial
Chloé Couret, Alexandra Poinas, Christelle Volteau, Valery-Pierre Riche, Marie-Laure Le Lez, Marie-Hélène Errera, Catherine Creuzot-Garcher, Stéphanie Baillif, Laurent Kodjikian, Catherine Ivan, Laurence Mathilde Le Jumeau de Kergaradec, Anne Chiffoleau, Alexandra Jobert, Julie Jaulin, Laetitia Biron, Elisabeth Hervouet, Michel Weber
Direct-to-Implant Extracellular Matrix Hammock-based Breast Reconstruction; Prepectoral or Subpectoral?
Diana L. Dyrberg, Gudjon L. Gunnarsson, Camilla Bille, Jens A. Sørensen, Jørn B. Thomsen
Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial
Gara Arteaga-Henríquez, Silvia Karina Rosales-Ortiz, Alejandro Arias-Vásquez, Istvan Bitter, Ylva Ginsberg, Pol Ibañez-Jimenez, Tünde Kilencz, Catharina Lavebratt, Silke Matura, Andreas Reif, Janos Rethelyi, Vanesa Richarte, Nanda Rommelse, Anne Siegl, J. Antoni Ramos-Quiroga
Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol
Mahsa Malekahmadi, Omid Moradi Moghaddam, Sheikh Mohammed Shariful Islam, Kiarash Tanha, Mohsen Nematy, Naseh Pahlavani, Safieh Firouzi, Mohammad Reza Zali, Abdolreza Norouzy
Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial
Shanshan Li, Qing Zhang, Xuan Yin, Hongyu Yue, Wei Zhang, Lixing Lao, Zhangjin Zhang, Huangan Wu, Shifen Xu
Instant analgesic effect of radial extracorporeal shock wave therapy on primary dysmenorrhoea according to functional magnetic resonance imaging: study protocol for a randomised placebo-controlled trial
Shanshan Liu, Lezheng Wang, Jian Yang
Comments to “PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial.”
Janusz Maciej Strzelczyk
Different electrode positioning for transcutaneous electrical nerve stimulation in the treatment of urgency in women: a study protocol for a randomized controlled clinical trial
Juliana Falcão Padilha, Mariana Arias Avila, Enio Júnior Seidel, Patricia Driusso
Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence
John Marsden, Paul Anders, Helen Clark, Kyriacos Colocassis, Brian Eastwood, Jonathan Knight, Alexandra Melaugh, David Quinn, Virginia Wright, Jez Stannard
Anticipatory care planning intervention for older adults at risk of functional decline: study protocol for a primary care cluster feasibility randomised trial
Kevin Brazil, David Scott, Emma Wallace, Mike Clarke, Tom Fahey, Patrick Gillespie, Peter O’Halloran, Christopher Cardwell, Gillian Carter, Kieran McGlade, Frank Doyle
Improving the accuracy and efficacy of diagnosing polycystic ovary syndrome by integrating metabolomics with clinical characteristics: study protocol for a randomized controlled trial
Cheng-Ming Ni, Wen-Long Huang, Yan-Min Jiang, Juan Xu, Ru Duan, Yun-Long Zhu, Xu-Ping Zhu, Xue-Mei Fan, Guo-An Luo, Yi-Ming Wang, Yan-Yu Li, Qing He, Lan Xu
A randomized controlled trial protocol comparing the feeds of fresh versus frozen mother’s own milk for preterm infants in the NICU
Huiqing Sun, Yun Cao, Shuping Han, Rui Cheng, Ling Liu, Jiangqin Liu, Shiwen Xia, Jiajie Zhang, Zhankui Li, Xiuyong Cheng, Chuanzhong Yang, Xinnian Pan, Long Li, Xin Ding, Rensheng Wang, Mingyuan Wu, Xiaoying Li, Liping Shi, Falin Xu, Fengqin Yu, Jiahua Pan, Xiaolan Zhang, Li Li, Jie Yang, Mingxia Li, Changhong Yan, Qi Zhou, Jiao Lu, Mou Wei, Laishuan Wang, Ling Yang, Xiang Y. Ye, Sharon Unger, Foteini Kakulas, Shoo K. Lee
A randomized controlled trial to reduce sedentary time in rheumatoid arthritis: protocol and rationale of the Take a STAND for Health study
Ana Jessica Pinto, Tiago Peçanha, Kamila Meireles, Fabiana Braga Benatti, Karina Bonfiglioli, Ana Lúcia de Sá Pinto, Fernanda Rodrigues Lima, Rosa Maria Rodrigues Pereira, Maria Claudia Costa Irigoyen, James Edward Turner, John P. Kirwan, Neville Owen, David W. Dunstan, Hamilton Roschel, Bruno Gualano
Correction to: Efficacy of Ronopterin (VAS203) in Patients with Moderate and Severe Traumatic Brain Injury (NOSTRA phase III trial): study protocol of a confirmatory, placebocontrolled, randomised, double blind, multi-centre study
Frank Tegtmeier, Reinhard Schinzel, Ronny Beer, Diederik Bulters, Jean-Yves LeFrant, Joan Sahuquillo, Andreas Unterberg, Peter Andrews, Antonio Belli, Javier Ibanez, Alfonso Lagares, Michael Mokry, Harald Willschke, Charlotte Flüh, Erich Schmutzhard
Evaluating a couple-based intervention addressing sexual concerns for breast cancer survivors: study protocol for a randomized controlled trial
Jennifer Barsky Reese, Lauren A. Zimmaro, Stephen J. Lepore, Kristen A. Sorice, Elizabeth Handorf, Mary B. Daly, Leslie R. Schover, Deborah Kashy, Kelly Westbrook, Laura S. Porter
My Bridge (Mi Puente), a care transitions intervention for Hispanics/Latinos with multimorbidity and behavioral health concerns: protocol for a randomized controlled trial
Linda C. Gallo, Addie L. Fortmann, Julia I. Bravin, Taylor L. Clark, Kimberly L. Savin, Duvia Lara Ledesma, Johanna Euyoque, Haley Sandoval, Scott C. Roesch, Todd Gilmer, Gregory A. Talavera, Athena Philis-Tsimikas
Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection
Achim J. Kaasch, Anna Rommerskirchen, Martin Hellmich, Gerd Fätkenheuer, Reinhild Prinz-Langenohl, Siegbert Rieg, Winfried V. Kern, Harald Seifert
Add-on effect of kinesiotape in patients with acute lateral ankle sprain: a randomized controlled trial
Jeong-Cheol Shin, Jae-Hong Kim, Dongwoo Nam, Gwang-Cheon Park, Jeong-Soon Lee
Effects of taichi on grade 1 hypertension: A study protocol for a randomized controlled trial
Sang-Hyun Lee, Byung-Jun Kim, In-Hwa Park, Eui-Hyoung Hwang, Eun Ju Park, Insoo Jang, Man-Suk Hwang
Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial
Roman Trepp, Raphaela Muri, Stephanie Abgottspon, Lenka Bosanska, Michel Hochuli, Johannes Slotboom, Christian Rummel, Roland Kreis, Regula Everts
Nasal Airway Obstruction Study (NAIROS): a phase III, open-label, mixed-methods, multicentre randomised controlled trial of septoplasty versus medical management of a septal deviation with nasal obstruction
Katherine J. Rennie, James O’Hara, Nikki Rousseau, Deborah Stocken, Denise Howel, Laura Ternent, Mike Drinnan, Alison Bray, Leila Rooshenas, David W. Hamilton, Alison Steel, Tony Fouweather, Ann-Marie Hynes, Eva-Maria Holstein, Yemi Oluboyede, Alaa Abouhajar, Janet A. Wilson, Sean Carrie, Quentin Gardiner, Paul Nix, Samuel Leong, Naveed Kara, Jillian Morrison, Sadie Khwaja, Sangeeta Maini, Jemima Dooley, Caroline Wilson, Ian Campbell, Maria Allen, Lyndsey Lindley, Joan Mackintosh
Effect of an educational booklet for prevention and treatment of foot musculoskeletal dysfunctions in people with diabetic neuropathy: the FOotCAre (FOCA) trial II, a study protocol of a randomized controlled trial
E. Q. Silva, E. Y. Suda, D. P. Santos, J. L. Veríssimo, J. S. S. P. Ferreira, R. H. Cruvinel Júnior, R. L. Monteiro, C. D. Sartor, I. C. N. Sacco
Pharmacokinetics, SAfety/tolerability, and EFficacy of high-dose RIFampicin in tuberculosis-HIV co-infected patients on efavirenz- or dolutegravir-based antiretroviral therapy: study protocol for an open-label, phase II clinical trial (SAEFRIF)
Ruth Nabisere, Joseph Musaazi, Paolo Denti, Florence Aber, Mohammed Lamorde, Kelly E. Dooley, Rob Aarnoutse, Derek J. Sloan, Christine Sekaggya-Wiltshire
Sustainable, healthy cities: protocol of a mixed methods evaluation of a cluster randomized controlled trial for Aedes control in Brazil using a community mobilization approach
Kate Zinszer, Andrea Caprara, Antonio Lima, Stéphanie Degroote, Monica Zahreddine, Kellyanne Abreu, Mabel Carabali, Katia Charland, Mayana Azevedo Dantas, José Wellington, Beatriz Parra, Florence Fournet, Emmanuel Bonnet, Denis Pérez, Emilie Robert, Christian Dagenais, Tarik Benmarhnia, Neil Andersson, Valéry Ridde
The smoking cessation in pregnancy incentives trial (CPIT): study protocol for a phase III randomised controlled trial
Lesley Sinclair, Margaret McFadden, Helen Tilbrook, Alex Mitchell, Ada Keding, Judith Watson, Linda Bauld, Frank Kee, David Torgerson, Catherine Hewitt, Jennifer McKell, Pat Hoddinott, Fiona M. Harris, Isabelle Uny, Kathleen Boyd, Nicola McMeekin, Michael Ussher, David M. Tappin
Addition of proprioceptive neuromuscular facilitation to cardiorespiratory training in patients poststroke: study protocol for a randomized controlled trial
Renata Janaína Pereira de Souza, Daniella Cunha Brandão, José Vicente Martins, Juliana Fernandes, Armele Dornelas de Andrade
The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a treatment for traumatized young refugees versus treatment as usual: study protocol for a multi-center randomized controlled trial (YOURTREAT)
Sarah Wilker, Claudia Catani, Jasmin Wittmann, Melissa Preusse, Telja Schmidt, Theodor May, Verena Ertl, Bettina Doering, Rita Rosner, Areej Zindler, Frank Neuner
Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial
Aldo Ferreira-Hermosillo, Mario Antonio Molina-Ayala, Diana Molina-Guerrero, Ana Pamela Garrido-Mendoza, Claudia Ramírez-Rentería, Victoria Mendoza-Zubieta, Etual Espinosa, Moisés Mercado
Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess the trustworthiness of claims about treatment effects: one-year follow up of a randomised trial
Daniel Semakula, Allen Nsangi, Andrew D. Oxman, Matt Oxman, Astrid Austvoll-Dahlgren, Sarah Rosenbaum, Angela Morelli, Claire Glenton, Simon Lewin, Laetitia Nyirazinyoye, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Christopher J. Rose, Nelson K. Sewankambo
Use of cannabinoid-based medicine among older residential care recipients diagnosed with dementia: study protocol for a double-blind randomised crossover trial
Amanda Timler, Caroline Bulsara, Max Bulsara, Alistair Vickery, Jill Smith, Jim Codde
Identifying treatment effects of an informal caregiver education intervention to increase days in the community and decrease caregiver distress: a machine-learning secondary analysis of subgroup effects in the HI-FIVES randomized clinical trial
Megan Shepherd-Banigan, Valerie A. Smith, Jennifer H. Lindquist, Michael Paul Cary Jr., Katherine E. M. Miller, Jennifer G. Chapman, Courtney H. Van Houtven
Outpatient balloon catheter vs inpatient prostaglandin for induction of labour (OBLIGE): a randomised controlled trial
Michelle R. Wise, Joy Marriott, Malcolm Battin, John M. D. Thompson, Michael Stitely, Lynn Sadler
Smartphone-based secondary prevention intervention for university students with unhealthy alcohol use identified by screening: study protocol of a parallel group randomized controlled trial
Nicolas Bertholet, Elodie Schmutz, Véronique S. Grazioli, Mohamed Faouzi, Jennifer McNeely, Gerhard Gmel, Jean-Bernard Daeppen, John A. Cunningham
Ticagrelor and preconditioning in patients with stable coronary artery disease (TAPER-S): a randomized pilot clinical trial
D. D’Amario, A. Restivo, A. M. Leone, R. Vergallo, S. Migliaro, F. Canonico, M. Galli, C. Trani, F. Burzotta, C. Aurigemma, G. Niccoli, A. Buffon, R. A. Montone, A. Flex, F. Franceschi, G. Tinelli, U. Limbruno, F. Francese, I. Ceccarelli, J. A. Borovac, I. Porto, F. Crea
Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial
Soobin Jang, Hyun Kyung Sung, Mi Mi Ko, Seon Mi Shin, Ho-Yeon Go, Jeeyoun Jung
A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty
Babar Kayani, Sujith Konan, Jenni Tahmassebi, Sam Oussedik, Peter D. Moriarty, Fares S. Haddad
Correction to: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments
Bethany M. Kwan, L. Miriam Dickinson, Russell E. Glasgow, Martha Sajatovic, Mark Gritz, Jodi Summers Holtrop, Don E. Nease Jr, Natalie Ritchie, Andrea Nederveld, Dennis Gurfinkel, Jeanette A. Waxmonsky
Correction to: Multicenter randomized controlled trial on the comparison of multi-family therapy (MFT) and systemic single-family therapy (SFT) in young patients with anorexia nervosa: study protocol of the THERAFAMBEST study
Benjamin Carrot, Jeanne Duclos, Caroline Barry, Leslie Radon, Anne-Solène Maria, Irène Kaganski, Zorica Jeremic, Vesper Barton-Clegg, Maurice Corcos, Malaïka Lasfar, Priscille Gerardin, Aurélie Harf, Marie-Rose Moro, Corinne Blanchet, Stéphane Bahrami, Nathalie Godart
A randomised, multi-centre trial of total ankle replacement versus ankle arthrodesis in the treatment of patients with end stage ankle osteoarthritis (TARVA): statistical analysis plan
Patrick Muller, Simon S. Skene, Kashfia Chowdhury, Suzie Cro, Andrew J. Goldberg, Caroline J. Doré, Stephen Bendall, Andrew Bing, Chris Blundell, Rick Brown, Clifford Butcher, Michael Butler, Tim Clough, Paul Cooke, Nick Cullen, James Davenport, Mark Davies, Sunil Dhar, Andy Goldberg, Paul Halliwell, Bill Harries, Stephen Hepple, Raj Kakwani, Mike Karski, David Loveday, Nilesh Makwana, Steve Milner, Viren Mishra, Andrew Molloy, An Murty, Martin Raglan, Benedict Rogers, Mark Rogers, Malik Siddique, Dishan Singh, Rob Smith, Rhys Thomas, Paulo Torres, Dave Townshend, Matt Welck, Ian Winson
Driving Pressure During General Anesthesia for Open Abdominal Surgery (DESIGNATION): study protocol of a randomized clinical trial
Liselotte Hol, Sunny G. L. H. Nijbroek, Ary Serpa Neto, Marcelo Gama de Abreu, Paolo Pelosi, Sabrine N. T. Hemmes, Leon P. H. J. Aarts, Ronald D. L. Akkerman, Juliette J. E. Albersen, Caterina Aurilio, Denise Battaglini, Hans D. de Boer, Annemieke Boom, Christa Boer, Tammo Brouwer, Wolfgang F. F. A. Buhre, Carolina S. E. Bulte, Gitara M. Edward-Rutten, Marc B. Godfried, Hendrik J. F. Helmerhorst, Jan Hofland, Hester Hoogenboom, W. Ten Hoope, Bernard M. Houweling, Ragnar Huhn, Wanda Konijn, Ankie W. M. M. Koopman–van Gemert, Dianne J. de Korte-de Boer, Minke C. Kortekaas, Felix van Lier, Benedikt Preckel, Mandana Rad, Pasquale Sansone, André Stamkot, Robert Jan Stolker, Bram Thiel, Johannes F. H. Ubben, Michel M. R. F. Struys, Bastiaan A. in ‘t Veld, Hermann Wrigge, Miriam Zeillemaker-Hoekstra, Tim van der Zwan, Johannes H. M. J. Zwijsen, Markus W. Hollmann, Marcus J. Schultz
Update of the ULtra-early TRranexamic Acid after Subarachnoid Hemorrhage (ULTRA) trial: statistical analysis plan
René Post, Menno R. Germans, Bert A. Coert, Gabriël J. E. Rinkel, W. Peter Vandertop, Dagmar Verbaan
Evaluating the re-identification risk of a clinical study report anonymized under EMA Policy 0070 and Health Canada Regulations
Janice Branson, Nathan Good, Jung-Wei Chen, Will Monge, Christian Probst, Khaled El Emam
A randomized controlled trial investigating the effect of a diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols on the intestinal microbiome and inflammation in patients with ulcerative colitis: study protocol for a randomized controlled trial
Alireza Milajerdi, Omid Sadeghi, Seyed Davar Siadat, Seyed Ali Keshavarz, Alireza Sima, Homayoon Vahedi, Peyman Adibi, Ahmad Esmaillzadeh
Examining the benefits and harms of Alzheimer’s disease screening for family members of older adults: study protocol for a randomized controlled trial
Nicole R. Fowler, Katharine J. Head, Anthony J. Perkins, Sujuan Gao, Christopher M. Callahan, Tamilyn Bakas, Shelley D. Suarez, Malaz A. Boustani
Effect of transcranial direct current stimulation and multicomponent training on functional capacity in older adults: protocol for a randomized, controlled, double-blind clinical trial
Glaucio Carneiro Costa, João Carlos Ferrari Corrêa, Soraia Micaela Silva, Simone Dal Corso, Stefany Ferreira da Cruz, Micaelly de Souza Cunha, Paulo Henrique Leite Souza, Marcella Leiva Saldanha, Fernanda Ishida Corrêa
The effectiveness of additional thoracic paravertebral block in improving the anesthetic effects of regional anesthesia for proximal humeral fracture surgery in elderly patients: study protocol for a randomized controlled trial
Xiaofeng Wang, Hui Zhang, Zhenwei Xie, Qingfu Zhang, Wei Jiang, Junfeng Zhang
Primary or secondary wound healing of the pin sites after removal of the external fixator: study protocol for a prospective, randomized controlled, monocenter trial
Franz Roth, Flavio Cagienard, Björn C. Link, Sandro Hodel, Dirk Lehnick, Reto Babst, Frank J. P. Beeres
Initiating renal replacement therapy through incremental haemodialysis: Protocol for a randomized multicentre clinical trial
M. Fernández Lucas, G. Ruíz-Roso, J. L. Merino, R. Sánchez, H. Bouarich, J. A. Herrero, A. Muriel, J. Zamora, A. Collado
The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi
Maria H. Kim, Tapiwa A. Tembo, Alick Mazenga, Xiaoying Yu, Landon Myer, Rachael Sabelli, Robert Flick, Miriam Hartig, Elizabeth Wetzel, Katie Simon, Saeed Ahmed, Rose Nyirenda, Peter N. Kazembe, Mtisunge Mphande, Angella Mkandawire, Mike J. Chitani, Christine Markham, Andrea Ciaranello, Elaine J. Abrams
Can learning about trials be child’s play? A qualitative exploration of the ‘Schools Teaching Awareness of Randomised Trials’ (START) initiative
Linda Biesty, Sandra Galvin, Elaine Finucane, Patricia Healy, Declan Devane, Tom Conway
Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial
A. Hamish R. W. Simpson, Colin R. Howie, Elaine Kinsella, David F. Hamilton, Philip G. Conaghan, Catherine Hankey, Sharon Anne Simpson, Anna Bell-Higgs, Peter Craig, Nicholas D. Clement, Catriona Keerie, Sarah R. Kingsbury, Anthony R. Leeds, Hazel M. Ross, Hemant G. Pandit, Chris Tuck, John Norrie
Mesenteric excision surgery or conservative limited resection in Crohn’s disease: study protocol for an international, multicenter, randomized controlled trial
Yi Li, Helen Mohan, Nan Lan, Xiaojian Wu, Wei Zhou, Jianfeng Gong, Bo Shen, Luca Stocchi, J. Calvin Coffey, Weiming Zhu
Jakyakgamcho-tang in the relief of delayed-onset muscle soreness in healthy adults: study protocol for a randomized, double-blind, placebo-controlled, crossover design clinical trial
Kyungsun Han, Ojin Kwon, So-Young Jung, In-hwa Park, Man-Suk Hwang, Sun-Young Park, Eui-Hyoung Hwang, Jun-Hwan Lee
Atmiyata, a community-led intervention to address common mental disorders: Study protocol for a stepped wedge cluster randomized controlled trial in rural Gujarat, India
Kaustubh Joag, Jasmine Kalha, Deepa Pandit, Susmita Chatterjee, Sadhvi Krishnamoorthy, Laura Shields-Zeeman, Soumitra Pathare
Assessing effective interventions to improve trial retention: do they contain behaviour change techniques?
Eilidh M. Duncan, Tina Bennett, Katie Gillies
GERiatric Screening in the treatment of elderly patients with Ovarian Carcinoma (GERSOC): study protocol for a pragmatic, cluster randomised controlled trial
Neeltje J. van Soolingen, Carolina H. Smorenburg, Marije E. Hamaker, Wim G. Groen, Valesca P. Retèl, Christianne A. R. Lok, Lonneke V. van de Poll-Franse, Johannes W. Trum
What influenced people with chronic or refractory breathlessness and advanced disease to take part and remain in a drug trial? A qualitative study
N. Lovell, S. N. Etkind, S. Bajwah, M. Maddocks, I. J. Higginson
Randomized trial comparing low-pressure versus standard-pressure pneumoperitoneum in laparoscopic colectomy: PAROS trial
S. Celarier, S. Monziols, M. O. Francois, V. Assenat, P. Carles, M. Capdepont, C. Fleming, E. Rullier, G. Napolitano, Q. Denost
Study protocol of the multi-centre, randomised controlled trial of the Frankfurt Early Intervention Programme A-FFIP versus early intervention as usual for toddlers and preschool children with Autism Spectrum Disorder (A-FFIP study)
Janina Kitzerow, Matthes Hackbusch, Katrin Jensen, Meinhard Kieser, Michele Noterdaeme, Ulrike Fröhlich, Regina Taurines, Julia Geißler, Nicole Wolff, Veit Roessner, Nico Bast, Karoline Teufel, Ziyon Kim, Christine M. Freitag
Neuromuscular exercise and pain neuroscience education compared with pain neuroscience education alone in patients with chronic pain after primary total knee arthroplasty: study protocol for the NEPNEP randomized controlled trial
Jesper Bie Larsen, Søren T. Skou, Lars Arendt-Nielsen, Ole Simonsen, Pascal Madeleine
Comparison of the efficacy and safety of tacrolimus monotherapy and cyclophosphamide combined with glucocorticoid in the treatment of adult primary membranous nephropathy: protocol of a multicenter, randomized, controlled, open study
Shasha Chen, Song Ren, Amanda Y. Wang, Hieu Tran, Zheng Li, Xiaoyun Cheng, Manli Liu, Guisen Li, Li Wang, Daqing Hong
Effect of community active case-finding strategies for detection of tuberculosis in Cambodia: study protocol for a pragmatic cluster randomized controlled trial
Alvin Kuo Jing Teo, Kiesha Prem, Konstantin Evdokimov, Chetra Ork, Sothearith Eng, Sovannary Tuot, Monyrath Chry, Tan Eang Mao, Li Yang Hsu, Siyan Yi
Effects of synbiotic supplementation on energy and macronutrients homeostasis and muscle wasting of critical care patients: study protocol and a review of previous studies
Najmeh Seifi, Mohammad Safarian, Mohsen Nematy, Reza Rezvani, Majid Khadem-Rezaian, Alireza Sedaghat
CAPAbility: comparison of the JOURNEY II Bi-Cruciate Stabilised and GENESIS II total knee arthroplasty in performance and functional ability: protocol of a randomised controlled trial
Celia Clarke, Valerie Pomeroy, Allan Clark, Graham Creelman, Nicola Hancock, Simon Horton, Anne Killett, Charles Mann, Estelle Payerne, Andoni Toms, Gareth Roberts, Toby Smith, Ann Marie Swart, Iain McNamara
A randomised controlled trial of hearing and vision support in dementia: Protocol for a process evaluation in the SENSE-Cog trial
Iracema Leroi, Christopher J. Armitage, Fidéline Collin, Eric Frison, Mark Hann, Emma Hooper, David Reeves, Zoe Simkin, Lucas Wolski, Harvey Abrams, Nathalie Chaghil-Boissière, Anna Pavlina Charalambous, Fidéline Collin, Fofi Constantinidou, Lisa Crosby, Piers Dawes, Eric Frison, Camille Gilbert, Mark Hann, Emma Hooper, Ines Himmelsbach, Evangelia Kontogianni, Brian Lawlor, Iracema Leroi, Sarah Marie, Susana Montecelo, Antonios Politis, Otilia Postea, David Reeves, David Renaud, Zoe Simkin, Monique Termote, Chryssoula Thodi, Lucas Wolski
Efficacy of electroacupuncture on acute abdomen emergency care: study protocol for a randomized controlled trial
Yuan Ya Chang, Chih Wen Chiu, Chia Yun Chen, Chin Fu Chang, Tsung Chieh Lee, Lun Chien Lo, Chia Ying Lee, Kai Chang, Po Wei Chen, Chang Ju Hsieh, Yu Jun Chang, Sung Yen Huang
Effects of vitamin D and/or magnesium supplementation on mood, serum levels of BDNF, inflammatory biomarkers, and SIRT1 in obese women: a study protocol for a double-blind, randomized, placebo-controlled trial
Behnaz Abiri, Mohammadreza Vafa
Self-cut titanium-coated polypropylene mesh versus pre-cut mesh-kit for transvaginal treatment of severe pelvic organ prolapse: study protocol for a multicenter non-inferiority trial
Juan Chen, Jiajie Yu, Abraham Morse, Christian Fünfgeld, Kuanhui Huang, Jian Gong, Guangshi Tao, Binan Wang, Yuling Wang, Xiangyang Jiang, Gulina Ababaikeli, Peishu Liu, Hatiguli Nisier, Xiaowei Zhang, Ping Wang, Xin Sun, Lan Zhu
Promoting smoking abstinence in smokers willing to quit smoking through virtual reality-approach bias retraining: a study protocol for a randomized controlled trial
Alla Machulska, Tanja Joan Eiler, Armin Grünewald, Rainer Brück, Katharina Jahn, Björn Niehaves, Heiko Ullrich, Tim Klucken
Exclusion rates in randomized controlled trials of treatments for physical conditions: a systematic review
Jinzhang He, Daniel R. Morales, Bruce Guthrie
Effects of moving cupping therapy for plaque psoriasis: study protocol for a randomized multicenter clinical trial
Meng Xing, Xiaoning Yan, Suqing Yang, Linge Li, Liping Gong, Hongxia Liu, Rong Xu, Jie Chen, Luo Ying, Yiding Zhao, Yuepeng An, Yang Liu, Gang Huang, Fei Guo, Qingfeng Yin, Ruiping Wang, Bin Li, Xin Li
Promoting sport participation during early parenthood: a randomized controlled trial protocol
Stina J. Grant, Mark R. Beauchamp, Chris M. Blanchard, Valerie Carson, Ryan E. Rhodes
Responding to the challenge of Adolescent Perinatal Depression (RAPiD): protocol for a cluster randomized hybrid trial of psychosocial intervention in primary maternal care
Oye Gureje, Lola Kola, Bibilola D. Oladeji, Jibril Abdulmalik, Olatunde Ayinde, Phyllis Zelkowitz, Ian Bennett
Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trial
Jian Zhou, Chengwu Liu, Shulei Man, Mengyuan Lyu, Hu Liao, Nan Chen, Yuhui Cheng, Lunxu Liu
Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden
Erik Lundström, Eva Isaksson, Per Näsman, Per Wester, Björn Mårtensson, Bo Norrving, Håkan Wallén, Jörgen Borg, Martin Dennis, Gillian Mead, Graeme J. Hankey, Maree L. Hackett, Katharina S. Sunnerhagen, Ann Charlotte Laska, Bjarni Gudmundsson, Björn Cederin, Magnus Esbjörnsson, Bernice Wiberg, Maria Lantz, Jörg Teichert, Magnus Bergmann, Lennart Welin, Ulrika Löfmark, Sven-Erik Bysell, Xiaolei Hu, Axel Andersson, Moa Gunnarsson, Pernilla Sandgren, Eva Ask, Peter Thomasson Sommer, Bo Danielsson, Liisa Hopia, Andreas Arvidsson, Fredrik Björck, Anke Brederlau, Trandur Ulfarsson, Mehran Taklif, Magnus Gibson, Brita Eklund, Björn Hedström, Ellinore Richardsson, Daniel Merrick, Per Broman, Max Mademyr-Larsson, Andreas Ranhem, Camilla Ronnheden, Martin Johansson, Anette Onkenhout
Scaling up Quality Improvement for Surgical Teams (QIST) – avoiding surgical site infection and anaemia at the time of surgery: protocol for a cluster randomised controlled trial
Ashley B Scrimshire, Alison Booth, Caroline Fairhurst, Mike Reed, Win Tadd, Annie Laverty, Belen Corbacho, David Torgerson, Catriona McDaid
Effect and safety of 4% albumin in the treatment of cardiac surgery patients: study protocol for the randomized, double-blind, clinical ALBICS (ALBumin In Cardiac Surgery) trial
Hanna Vlasov, Tatu Juvonen, Seppo Hiippala, Raili Suojaranta, Markku Peltonen, Alexey Schramko, Kaapo Arvonen, Ulla-Stina Salminen, Ilona Kleine Budde, Tiina Eränen, Maxim Mazanikov, Mihkel Meinberg, Tommi Vähäsilta, Erika Wilkman, Ville Pettilä, Eero Pesonen
Mindfulness-based resilience training for aggression, stress and health in law enforcement officers: study protocol for a multisite, randomized, single-blind clinical feasibility trial
Michael Christopher, Sarah Bowen, Katie Witkiewitz
Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial)
Margot Baudelet, Leen Van den Steen, Fréderic Duprez, Marc De Bodt, Sarah Deschuymer, Ann Goeleven, Isabel Hutsebaut, Steven Mariën, Sabine Meersschout, Daan Nevens, Sandra Nuyts, Marc Peeters, Pol Specenier, Michiel Van den Brekel, Lisette van der Molen, Caroline Vandenbruaene, Olivier Vanderveken, Joost Van Dinther, Carl Van Laer, Tom Vauterin, Hilde Verstraete, Gwen Van Nuffelen
Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey
Roulla Katiri, Deborah A. Hall, Nora Buggy, Nicholas Hogan, Adele Horobin, Paul van de Heyning, Jill B. Firszt, Iain A. Bruce, Pádraig T. Kitterick
A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome
Shiya Huang, Min Hu, Ernest Hung Yu Ng, Elisabet Stener-Victorin, Yanhua Zheng, Qidan Wen, Cong Wang, Maohua Lai, Juan Li, Xingcheng Gao, Xinhua Wang, Zhenxing Hu, Tian Xia, Rongkui Hu, Jianping Liu, Xiaohui Wen, Shuna Li, Kewei Quan, Xingyan Liang, Hongcai Shang, Hongxia Ma, Jie Qiao
A nurse-led health coaching intervention for stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China: a study protocol for a randomized controlled trial
Shuanglan Lin, Lily Dongxia Xiao, Diane Chamberlain
Verifying participant-reported clinical outcomes: challenges and implications
Suzanne Breeman, Lynda Constable, Anne Duncan, Kath Starr, Alison McDonald, Samantha Wileman, Seonaidh Cotton
Therapeutic iloprost for the treatment of acute respiratory distress syndrome (ARDS) (the ThIlo trial): a prospective, randomized, multicenter phase II study
Helene Haeberle, Stefanie Prohaska, Peter Martus, Andreas Straub, Alexander Zarbock, Gernot Marx, Manola Zago, Martin Giera, Michael Koeppen, Peter Rosenberger
A Community-based Assessment of Skin Care, Allergies, and Eczema (CASCADE): an atopic dermatitis primary prevention study using emollients—protocol for a randomized controlled trial
Brian Eichner, Le Ann C. Michaels, Kelsey Branca, Katrina Ramsey, Julie Mitchell, Cynthia D. Morris, Lyle J. Fagnan, Rowena J. Dolor, Nancy Elder, David L. Hahn, Donald E. Nease, Jodi Lapidus, Ricardo Cibotti, Julie Block, Eric L. Simpson
Recruitment of low-income pregnant women into a dietary and dental care intervention: lessons from a feasibility trial
Amanda Rodrigues Amorim Adegboye, Paula G. Cocate, Camila Benaim, Maria Claudia da Veiga Soares Carvalho, Michael M. Schlüssel, Maria Beatriz T. de Castro, Gilberto Kac, Berit L. Heitmann
Effects of Transcranial Direct Current Stimulation (tDCS) and Approach Bias Modification (ABM) training on food cravings in people taking antipsychotic medication
Luiza Grycuk, Gemma Gordon, Fiona Gaughran, Iain C. Campbell, Ulrike Schmidt
Patient experience of the informed consent process during acute myocardial infarction: a sub-study of the VALIDATE-SWEDEHEART trial
Anneli Olsson, Camilla Ring, Johan Josefsson, Annika Eriksson, Rebecca Rylance, Ole Fröbert, Stefan James, David Sparv, David Erlinge
Protocol for a randomised trial of early kangaroo mother care compared to standard care on survival of pre-stabilised preterm neonates in The Gambia (eKMC)
Helen Brotherton, Abdou Gai, Cally J. Tann, Ahmadou Lamin Samateh, Anna C. Seale, Syed M. A. Zaman, Simon Cousens, Anna Roca, Joy E. Lawn
The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain
Travis Cleland, Nitin B. Jain, John Chae, Kristine M. Hansen, Terri Z. Hisel, Douglas D. Gunzler, Victoria C. Whitehair, Chong H. Kim, Richard D. Wilson
A study of capecitabine metronomic chemotherapy is non-inferior to conventional chemotherapy as maintenance strategy in responders after induction therapy in metastatic colorectal cancer
Min Shi, Tao Ma, Wenqi Xi, Jinling Jiang, Junwei Wu, Chenfei Zhou, Chen Yang, Zhenggang Zhu, Jun Zhang
Correction to: Effectiveness of Gyejibongnyeong-Hwan for shoulder pain: study protocol for a randomised, wait-list controlled pilot trial
Soobin Jang, Hyun Kyung Sung, Mi Mi Ko, Seon Mi Shin, Ho-Yeon Go, Jeeyoun Jung
Designs for adding a treatment arm to an ongoing clinical trial
Maxine Bennett, Adrian P. Mander
How can health economics be used in the design and analysis of adaptive clinical trials? A qualitative analysis
Laura Flight, Steven Julious, Alan Brennan, Susan Todd, Daniel Hind
Effectiveness and cost-effectiveness of guided Internet- and mobile-based CBT for adolescents and young adults with chronic somatic conditions and comorbid depression and anxiety symptoms (youthCOACHCD): study protocol for a multicentre randomized controlled trial
Frederike Lunkenheimer, Matthias Domhardt, Agnes Geirhos, Reinhold Kilian, Annabel S. Mueller-Stierlin, Reinhard W. Holl, Thomas Meissner, Kirsten Minden, Morten Moshagen, Ramona Ranz, Cedric Sachser, Doris Staab, Petra Warschburger, Harald Baumeister
Effectiveness of LiuZiJue Qigong versus traditional core stability training for poststroke patients complicated with abnormal trunk postural control: study protocol for a single-center randomized controlled trial
Chen Wang, Long Yu, Jian Yang, Ren Wei Wang, Ya Nan Zheng, Ying Zhang
The effectiveness of a comprehensive corrective exercises program and subsequent detraining on alignment, muscle activation, and movement pattern in men with upper crossed syndrome: protocol for a parallel-group randomized controlled trial
Mohammad Bayattork, Foad Seidi, Hooman Minoonejad, Lars Louis Andersen, Phil Page
Improved recording of work relatedness during patient consultations in occupational primary health care: a cluster randomized controlled trial using routine data
Salla Atkins, Tiia Reho, Nina Talola, Markku Sumanen, Mervi Viljamaa, Jukka Uitti
Correction to: 3D vs. 4 K Display System - Influence of “State-of-the-art”-Display Technique On Surgical Performance (IDOSP-Study) in minimally invasive surgery: protocol for a randomized cross-over trial
Roger Wahba, Rabi Raj Datta, Andrea Hedergott, Jana Bußhoff, Thomas Bruns, Robert Kleinert, Georg Dieplinger, Hans Fuchs, Caroline Gietzelt, Desdemona Möller, Martin Hellmich, Christiane J. Bruns, Dirk L. Stippel
CareConekta: study protocol for a randomized controlled trial of a mobile health intervention to improve engagement in postpartum HIV care in South Africa
Kate Clouse, Tamsin K. Phillips, Carol Camlin, Sandisiwe Noholoza, Phepo Mogoba, Julian Naidoo, Richard Langford, Martin Weiss, Christopher J. Seebregts, Landon Myer
Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators
Rebecca Sheridan, Jacqueline Martin-Kerry, Joanna Hudson, Adwoa Parker, Peter Bower, Peter Knapp
Acupoint combination effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in treating insomnia: study protocol for a randomized controlled trial
Pei Wu, Cisong Cheng, Xiaojun Song, Ling Yang, Dandan Deng, Zhenrong Du, Xingyu Chen, Tingting Zou, Ling Qiao, Na Li, Pingping Zhou, Li Du, Yihui Zhu
A phase 2 randomised controlled trial of serelaxin to lower portal pressure in cirrhosis (STOPP)
Fiona J. Gifford, Philip D. J. Dunne, Graeme Weir, Hamish Ireland, Catriona Graham, Sharon Tuck, Peter C. Hayes, Jonathan A. Fallowfield
Outcome reporting in neonates experiencing withdrawal following opioid exposure in pregnancy: a systematic review
Flora Shan, Sonya MacVicar, Karel Allegaert, Martin Offringa, Lauren M. Jansson, Sarah Simpson, Wendy Moulsdale, Lauren E. Kelly
Transcranial direct current stimulation (tDCS) as an intervention to improve empathic abilities and reduce violent behavior in forensic offenders: study protocol for a randomized controlled trial
Carmen S. Sergiou, Adam J. Woods, Ingmar H. A. Franken, Josanne D. M. van Dongen
Different kinds of acupuncture treatments for knee osteoarthritis: a multicentre, randomized controlled trial
Qifei Zhang, Jianqiao Fang, Lifang Chen, Jiayao Wu, Jing Ni, Fang Liu, Jing Sun
Treating anxiety in autistic adults: study protocol for the Personalised Anxiety Treatment–Autism (PAT-A©) pilot randomised controlled feasibility trial
Jeremy R. Parr, Samuel Brice, Patrick Welsh, Barry Ingham, Ann Le Couteur, Gemma Evans, Alexander Monaco, Mark Freeston, Jacqui Rodgers
Efficacy and safety of Shu-gan-qing-re formula for generalized anxiety disorder: study protocol for a multi-center, prospective, double-blind, double-dummy, randomized controlled trial
Pei Chen, Hong Zhu, Yanzhe Ning, Dongqing Yin, Hongxiao Jia
Effects of Astragalus injection and Salvia Miltiorrhiza injection on serum inflammatory markers in patients with stable coronary heart disease: a randomized controlled trial protocol
Zhihao Luo, Yuntao Liu, Zhen Zhao, Xia Yan, Dawei Wang, Qing Liu
Protocol for a mixed methods process evaluation of a hybrid implementation-effectiveness trial of a scaled-up whole-school physical activity program for adolescents: Physical Activity 4 Everyone (PA4E1)
Matthew Mclaughlin, Jed Duff, Rachel Sutherland, Elizabeth Campbell, Luke Wolfenden, John Wiggers
Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): protocol for a feasibility cluster-randomised controlled trial
Christopher P. Dwyer, Alberto Alvarez-Iglesias, Robert Joyce, Timothy J. Counihan, Dympna Casey, Sinéad M. Hynes
Positive deviance for dual-method promotion among women in Uganda: study protocol for a cluster randomized controlled trial
Hodaka Kosugi, Akira Shibanuma, Junko Kiriya, Ken Ing Cherng Ong, Stephen Mucunguzi, Conrad Muzoora, Masamine Jimba
Efficacy of Tuina in patients with chronic low back pain: study protocol for a randomized controlled trial
Shuaipan Zhang, Lingjun Kong, Qingguang Zhu, Zhiwei Wu, Jianhua Li, Min Fang, Wuquan Sun, Yanbin Cheng, Shanda Xu, Guangxin Guo, Xin Zhou, Zhizhen Lv
Correction to: Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey
Roulla Katiri, Deborah A. Hall, Nora Buggy, Nicholas Hogan, Adele Horobin, Paul van de Heyning, Jill B. Firszt, Iain A. Bruce, Pádraig T. Kitterick
Correction to: Protocol and baseline data for a prospective open-label explorative randomized singlecenter comparative study to determine the effects of various intravenous iron preparations on markers of oxidative stress and kidney injury in chronic kidney disease (IRON-CKD)
Ahmed Ziedan, Xenophon Kassianides, Sunil Bhandari
Protocol for TRAUMADORNASE: a prospective, randomized, multicentre, double-blinded, placebo-controlled clinical trial of aerosolized dornase alfa to reduce the incidence of moderate-to-severe hypoxaemia in ventilated trauma patients
Julien Pottecher, Eric Noll, Marie Borel, Gérard Audibert, Sébastien Gette, Christian Meyer, Elisabeth Gaertner, Vincent Legros, Raphaël Carapito, Béatrice Uring-Lambert, Erik Sauleau, Walter G. Land, Seiamak Bahram, Alain Meyer, Bernard Geny, Pierre Diemunsch
Implementation of the patient version of the evidence-based (S3) guideline for psychosocial interventions for patients with severe mental illness (IMPPETUS): study protocol for a cluster randomised controlled trial
Johanna Breilmann, Reinhold Kilian, Steffi G. Riedel-Heller, Uta Gühne, Alkomiet Hasan, Peter Falkai, Andreas Allgöwer, Rainer Muche, Thomas Becker, Klemens Ajayi, Peter Brieger, Karel Frasch, Stephan Heres, Markus Jäger, Andreas Küthmann, Albert Putzhammer, Max Schmauß, Bertram Schneeweiß, Michael Schwarz, Markus Kösters
Standardized patients in psychotherapy training and clinical supervision: study protocol for a randomized controlled trial
Franziska Kühne, Peter Eric Heinze, Florian Weck
Protocol for a randomized control trial of the caregiver support intervention with Syrian refugees in Lebanon
Kenneth E. Miller, Maguy Arnous, Fadila Tossyeh, Alexandra Chen, Ioannis Bakolis, Gabriela V. Koppenol-Gonzalez, Nayla Nahas, Mark J. D. Jordans
Ginger in patients with active ulcerative colitis: a study protocol for a randomized controlled trial
Forough Shayesteh, Fatemeh Haidari, Ali Akbar Shayesteh, Javad Mohammadi-Asl, Kambiz Ahmadi-Angali
Evaluating the myopia progression control efficacy of defocus incorporated multiple segments (DIMS) lenses and Apollo progressive addition spectacle lenses (PALs) in 6- to 12-year-old children: study protocol for a prospective, multicenter, randomized controlled trial
Yan Li, Yafei Fu, Kai Wang, Zhiming Liu, Xiaoqing Shi, Mingwei Zhao
Impact of continuous Kangaroo Mother Care initiated immediately after birth (iKMC) on survival of newborns with birth weight between 1.0 to < 1.8 kg: study protocol for a randomized controlled trial
Ebunoluwa Aderonke Adejuyigbe, Pratima Anand, Daniel Ansong, Chineme Henry Anyabolu, Sugandha Arya, Evelyne Assenga, Ibraheem Awowole, Monika Bahl, Rajiv Bahl, Jill Bergman, Nils Bergman, Adwoa Boakye-Yiadom, Rahul Chauhan, Harish Chellani, Nidhi Chopra, Rupali Dewan, Queen Dube, Luis Gadama, Harsh Vardhan Jaiswal, Kondwani Kawaza, Bankole Peter Kuti, Oluwafemi Kuti, Roderick Larsen-Reindorf, Agnes Linnér, Alexander Manu, Augustine Massawe, Nicole Minckas, Pratima Mittal, Ausbert Msusa, Helga Naburi, Sam Newton, Matilda Ngarina, Ayodele Olanrewaju Oladele, Gyikua Phlange-Rhule, Cynthia Pillegi-Castro, Nisha Rani, P. N. Suman Rao, Siren Rettedal, Isha Saini, Vincent Samuel, Richa Singhal, Jyotsana Suri, Nitya Wadhwa, Björn Westrup, Naana Wireko-Brobby, Sachiyo Yoshida
How pragmatic are the randomised trials used in recommendations for control of glycosylated haemoglobin levels in type 2 diabetic patients in general practice: an application of the PRECIS II tool
Isabelle Ettori-Ajasse, Elise Tatin, Gordon Forbes, Sandra Eldridge, Clarisse Dibao-Dina
Correction to: Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial
Karen M. Benzies, Vibhuti Shah, Khalid Aziz, Wanrudee Isaranuwatchai, Luz Palacio-Derflingher, Jeanne Scotland, Jill Larocque, Kelly Mrklas, Esther Suter, Christopher Naugler, Henry T. Stelfox, Radha Chari, Abhay Lodha
Protocol for a randomized controlled trial: peer-to-peer Group Problem Management Plus (PM+) for adult Syrian refugees in Turkey
Ersin Uygun, Zeynep Ilkkursun, Marit Sijbrandij, A. Tamer Aker, Richard Bryant, Pim Cuijpers, Daniela C. Fuhr, Anne M. de Graaff, Joop de Jong, David McDaid, Naser Morina, A-La Park, Bayard Roberts, Peter Ventevogel, Taylan Yurtbakan, Ceren Acarturk
Correction to: Comparison of the effectiveness of a tailored cognitive behavioural therapy with a supportive listening intervention for depression in those newly diagnosed with multiple sclerosis (the ACTION-MS trial): protocol of an assessor-blinded, active comparator, randomised controlled trial
Litza Kiropoulos, Trevor Kilpatrick, Tomas Kalincik, Leonid Churilov, Elizabeth McDonald, Tissa Wijeratne, Jennifer Threader, Vanja Rozenblat, Neil O’Brien-Simpson, Anneke Van Der Walt, Lisa Taylor
Family conferences and shared prioritisation to improve patient safety in the frail elderly (COFRAIL): study protocol of a cluster randomised intervention trial in primary care
Achim Mortsiefer, Stefan Wilm, Sara Santos, Susanne Löscher, Anja Wollny, Eva Drewelow, Manuela Ritzke, Petra Thürmann, Nina-Kristin Mann, Gabriele Meyer, Jens Abraham, Andrea Icks, Joseph Montalbo, Birgitt Wiese, Attila Altiner, Johanna Bensch, Madaida Lemke, Henrik Wiegelmann, Marjan van den Akker, Christoph Ostgathe, Vera Kalitzkus, Sven Schmiedl, Veronika Bencheva, Steffen Fleischer, Markus Vomhof
When assessing generalisability, focusing on differences in population or setting alone is insufficient
Helen E. D. Burchett, Dylan Kneale, Laurence Blanchard, James Thomas
Tongmai Yangxin intervening in myocardial remodeling after PCI for coronary heart disease: study protocol for a double-blind, randomized controlled trial
Yongxia Wang, Xinlu Wang, Jianru Wang, Bin Li, Rui Yu, Yucai Hu, Xingyuan Li, Guangcao Peng, Mengmeng Zhang, Mingjun Zhu
Adjunct low-dose ketamine infusion vs standard of care in mechanically ventilated critically ill patients at a Tertiary Saudi Hospital (ATTAINMENT Trial): study protocol for a randomized, prospective, pilot, feasibility trial
Mohammed Bawazeer, Marwa Amer, Khalid Maghrabi, Kamel Alshaikh, Rashid Amin, Muhammad Rizwan, Mohammad Shaban, Edward De Vol, Mohammed Hijazi
Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study
Jennifer F. Bobb, Hongxiang Qiu, Abigail G. Matthews, Jennifer McCormack, Katharine A. Bradley
A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: study protocol of a three-group randomized controlled trial
Katleen Van der Gucht, Michelle Melis, Soumaya Ahmadoun, Anneleen Gebruers, Ann Smeets, Mathieu Vandenbulcke, Hans Wildiers, Patrick Neven, Peter Kuppens, Filip Raes, Stefan Sunaert, Sabine Deprez
Efficacy and safety of PERIOdontal treatment versus usual care for Nonalcoholic liver disease: protocol of the PERION multicenter, two-arm, open-label, randomized trial
Yohei Kamata, Takaomi Kessoku, Tomoko Shimizu, Takashi Kobayashi, Takeo Kurihashi, Satsuki Sato, Syotaro Kuraji, Norio Aoyama, Tomoyuki Iwasaki, Shogo Takashiba, Nobushiro Hamada, Toshiro Kodama, Toshiyuki Tamura, Satoshi Ino, Takuma Higurashi, Masataka Taguri, Takeharu Yamanaka, Masato Yoneda, Haruki Usuda, Koichiro Wada, Atsushi Nakajima, Masato Minabe
An international, Delphi consensus study to identify priorities for methodological research in behavioral trials in health research
Molly Byrne, Jenny McSharry, Oonagh Meade, Kim L. Lavoie, Simon L. Bacon
Postoperative complications and mobilisation following major abdominal surgery with vs. without fitness tracker-based feedback (EXPELLIARMUS): study protocol for a student-led multicentre randomised controlled trial (CHIR-Net SIGMA study group)
Marius Schwab, Niall Brindl, Alexander Studier-Fischer, Thomas Tu, Julia Gsenger, Max Pilgrim, Mirco Friedrich, Pia-Elena Frey, Christina Achilles, Alexander Leuck, Thore Bürgel, Manuel Feisst, Christina Klose, Solveig Tenckhoff, Colette Dörr-Harim, André L. Mihaljevic
Traumatic brain injury—needs and treatment options in the chronic phase: Study protocol for a randomized controlled community-based intervention
Ida Maria H. Borgen, Marianne Løvstad, Nada Andelic, Solveig Hauger, Solrun Sigurdardottir, Helene L. Søberg, Unni Sveen, Marit V. Forslund, Ingerid Kleffelgård, Marte Ørud Lindstad, Laraine Winter, Cecilie Røe
Light-enhanced cognitive behavioural therapy for sleep and fatigue: study protocol for a randomised controlled trial during chemotherapy for breast cancer
Helena R. Bean, Lesley Stafford, Ruth Little, Justine Diggens, Maria Ftanou, Marliese Alexander, Prudence A. Francis, Bei Bei, Joshua F. Wiley
Correction to: Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study
Yuqin Chen, Wenjun He, Haiping Ouyang, Chunli Liu, Cheng Hong, Tao Wang, Kai Yang, Wenju Lu, Jian Wang
Correction to: Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial
Ling Zhu, Xiao Shi, Suqing Yin, Jiemin Yin, Ziyu Zhu, Xiong Gao, Yingfu Jiao, Weifeng Yu, Liqun Yang
Phase II, open-label, multicenter trial of crizotinib in Japanese patients with advanced non-small cell lung cancer harboring a MET gene alteration: Co-MET study
Mototsugu Shimokawa, Kaname Nosaki, Takashi Seto, Kadoaki Ohashi, Masahiro Morise, Hidehito Horinouchi, Jun Sakakibara, Haruyasu Murakami, Seiji Yano, Miyako Satouchi, Shingo Matsumoto, Koichi Goto, Kiyotaka Yoh
Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine
Xiaoying Sun, Xiaoyong Zhou, Yuegang Wei, Wenxin Yang, Ning Huang, Yangfeng Ding, Rongyi Hu, Shun Guo, Chunyan Yang, Huilan Weng, Ying Zhang, Xi Chen, Xiaojie Ding, Liu Liu, Qingfeng Yin, Ruiping Wang, Xin Li, Bin Li
Development of a Core Outcome Set for Studies on Cardiac Disease in Pregnancy (COSCarP): a study protocol
Rohan D’Souza, Chelsea Hall, Mathew Sermer, Samuel Siu, Candice Silversides
Sample size calculation in randomised phase II selection trials using a margin of practical equivalence
Hakim-Moulay Dehbi, Allan Hackshaw
Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2)
Mark Hayward, Clio Berry, Ben Cameron, Kate Arnold, Katherine Berry, Stephen Bremner, Kate Cavanagh, David Fowler, Heather Gage, Kathryn Greenwood, Cassie Hazell, Anna-Marie Jones, Sam Robertson, Clara Strauss
PALLiON – PALLiative care Integrated in ONcology: study protocol for a Norwegian national cluster-randomized control trial with a complex intervention of early integration of palliative care
Marianne Jensen Hjermstad, Nina Aass, Sigve Andersen, Cinzia Brunelli, Olav Dajani, Herish Garresori, Hanne Hamre, Ellinor C. Haukland, Mats Holmberg, Frode Jordal, Hilde Krogstad, Tonje Lundeby, Erik Torbjørn Løhre, Svein Mjåland, Arve Nordbø, Ørnulf Paulsen, Erik Schistad Staff, Torunn Wester, Stein Kaasa, Jon Håvard Loge
Using digital tools in the recruitment and retention in randomised controlled trials: survey of UK Clinical Trial Units and a qualitative study
Amanda Blatch-Jones, Jacqueline Nuttall, Abby Bull, Louise Worswick, Mark Mullee, Robert Peveler, Stephen Falk, Neil Tape, Jeremy Hinks, Athene J. Lane, Jeremy C. Wyatt, Gareth Griffiths
Music to improve sleep quality in adults with depression-related insomnia (MUSTAFI): study protocol for a randomized controlled trial
Helle Nystrup Lund, Inge Nygaard Pedersen, Søren Paaske Johnsen, Agnieszka M. Heymann-Szlachcinska, Maryla Tuszewska, Gustav Bizik, Jens Ivar Larsen, Eszter Kulhay, Anelia Larsen, Bettina Grønbech, Helle Østermark, Heidi Borup, Jan Brink Valentin, Jan Mainz
Robotic radical antegrade modular pancreatosplenectomy (RAMPS) versus standard retrograde pancreatosplenectomy (SRPS): study protocol for a randomized controlled trial
Gong Zhang, Yuhao Kang, Haifeng Zhang, Fei Wang, Rong Liu
Prospective evaluation of hydroxychloroquine in pediatric interstitial lung diseases: Study protocol for an investigator-initiated, randomized controlled, parallel-group clinical trial
Matthias Griese, Meike Köhler, Sabine Witt, Daniela Sebah, Matthias Kappler, Martin Wetzke, Nicolaus Schwerk, Nagehan Emiralioglu, Nural Kiper, Kai Kronfeld, Christian Ruckes, Hans Rock, Gisela Anthony, Elias Seidl
Reporting of health equity considerations in cluster and individually randomized trials
Jennifer Petkovic, Janet Jull, Manosila Yoganathan, Omar Dewidar, Sarah Baird, Jeremy M. Grimshaw, Kjell Arne Johansson, Elizabeth Kristjansson, Jessie McGowan, David Moher, Mark Petticrew, Bjarne Robberstad, Beverley Shea, Peter Tugwell, Jimmy Volmink, George A. Wells, Margaret Whitehead, Luis Gabriel Cuervo, Howard White, Monica Taljaard, Vivian Welch
The effect of comprehensive rehabilitation program plus chemotherapy on quality of life in patients with postoperative non-small-cell lung cancer: study protocol of a multicenter randomized clinical trial
Jialin Yao, Lijing Jiao, Yiqing Yao, Yan Lu, Jun Shi, Jiaqi Li, Peiqi Chen, Ling Xu, Yabin Gong
Effect of xenon and dexmedetomidine as adjuncts for general anesthesia on postoperative emergence delirium after elective cardiac catheterization in children: study protocol for a randomized, controlled, pilot trial
Sarah Devroe, Lisa Devriese, Frederik Debuck, Steffen Fieuws, Bjorn Cools, Marc Gewillig, Marc Van de Velde, Steffen Rex
The EMPOWER-SUSTAIN e-Health Intervention to improve patient activation and self-management behaviours among individuals with Metabolic Syndrome in primary care: study protocol for a pilot randomised controlled trial
Maryam Hannah Daud, Anis Safura Ramli, Suraya Abdul-Razak, Mohamad Rodi Isa, Fakhrul Hazman Yusoff, Noorhida Baharudin, Mohamed Syarif Mohamed-Yassin, Siti Fatimah Badlishah-Sham, Azlina Wati Nikmat, Nursuriati Jamil, Hapizah Mohd-Nawawi
Cost-utility analysis of curative and maintenance repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant unipolar depression: a randomized controlled trial protocol
Samuel Bulteau, Andrew Laurin, Christelle Volteau, Cécile Dert, Lydie Lagalice, Solène Schirr-Bonnans, Nicolas Bukowski, Marie Guitteny, Luc Simons, Clémence Cabelguen, Anne Pichot, Fabienne Tessier, Annabelle Bonnin, Adeline Lepage, Jérôme Attal, Jean-Marie Batail, René Benadhira, Djamila Bennabi, Caroline Berjamin, Maxime Bonnin, Noomane Bouaziz, Jérôme Brunelin, Maxime Bubrovszky, Benjamin Calvet, Irina-Alexandra Catana, Macarena Cuenca, Gaelle Dall’ Igna, Dominique Drapier, Laurine Egreteau, Wissam El-Hage, Filipe Galvao, Ghina Germaneau, Bénédicte Gohier, Emmanuel Haffen, Ghassan Harika, Guillaume Ifrah, Némat Jaafari, Isabelle Jalenques, Dominique Januel, Redwan Maatoug, Bruno Millet, Clément Nathou, Benjamin Petit, Damien Pierre, Marion Plaze, Emmanuel Poulet, Gabriel Robert, Maud Rotharmel, Marine Rozet, David Szekely, Simon Taib, Benoît Trojak, Antoine Yrondi, Jean-Marie Vanelle, Anne Sauvaget, Valery-Pierre Riche
Effectiveness of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease-modifying antirheumatic drugs (TOPIRA): study protocol for a pragmatic trial
Matthijs S. van der Leeuw, Paco M. J. Welsing, Maria J. H. de Hair, Johannes W. G. Jacobs, Anne C. A. Marijnissen, Suzanne P. Linn-Rasker, Faouzia Fodili, Reinhard Bos, Janneke Tekstra, Jacob M. van Laar
A simulation study comparing the power of nine tests of the treatment effect in randomized controlled trials with a time-to-event outcome
Patrick Royston, Mahesh K. B. Parmar
Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study
Gareth Davies, Nicola Mills, Chris Holcombe, Shelley Potter, N. L. P. Barnes, J. M. Blazeby, O. A. Branford, R. I. Cutress, M. D. Gardiner, C. Holcombe, A. Jain, K. McEvoy, N. Mills, S. Mylvaganam, S. Potter, J. M. Skillman, E. M. Teasdale, S. Thrush, Z. Tolkien, L. J. Whisker
Correction to: Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
Silje Haukenes Stavestrand, Kristine Sirevåg, Inger Hilde Nordhus, Trond Sjøbø, Trygve Bruun Endal, Hans M. Nordahl, Karsten Specht, Åsa Hammar, Anne Halmøy, Egil W. Martinsen, Eva Andersson, Helene Hjelmervik, Jan Mohlman, Julian F. Thayer, Anders Hovland
Mother And late Preterm Lactation Study (MAPLeS): a randomised controlled trial testing the use of a breastfeeding meditation by mothers of late preterm infants on maternal psychological state, breast milk composition and volume, and infant behaviour and growth
Sarah Dib, Jonathan C. K. Wells, Mary Fewtrell
Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation
Abhimanyu Sud, Michelle L. A. Nelson, Darren K. Cheng, Alana Armas, Kirk Foat, Michelle Greiver, Fardous Hosseiny, Joel Katz, Rahim Moineddin, Benoit H. Mulsant, Ronnie I. Newman, Leon Rivlin, Akshya Vasudev, Ross Upshur
Upfront radical surgery with total mesorectal excision followed by adjuvant FOLFOX chemotherapy for locally advanced rectal cancer (TME-FOLFOX): an open-label, multicenter, phase II randomized controlled trial
Jii Bum Lee, Han Sang Kim, Inkyung Jung, Sang Joon Shin, Seung Hoon Beom, Jee Suk Chang, Woong Sub Koom, Tae Il Kim, Hyuk Hur, Byung Soh Min, Nam Kyu Kim, Sohee Park, Seung-Yong Jeong, Jeong-Heum Baek, Seon Hahn Kim, Joon Seok Lim, Kang Young Lee, Joong Bae Ahn
Contact-Force-Sensing-Based Radiofrequency Catheter Ablation in Paroxysmal Supraventricular Tachycardias (COBRA-PATH): a randomized controlled trial
Tamas Geczy, Nawin L. Ramdat Misier, Tamas Szili-Torok
The use of digitally collected patient-reported outcome measures for newly operated patients with total knee and hip replacements to improve post-treatment recovery: study protocol for a randomized controlled trial
David Kuklinski, Laura Oschmann, Christoph Pross, Reinhard Busse, Alexander Geissler
Methods for safety and endpoint ascertainment: identification of adverse events through scrutiny of negatively adjudicated events
Alexander C. Fanaroff, Ghazala Haque, Betsy Thomas, Allegra E. Stone, Lynn M. Perkins, Matthew Wilson, W. Schuyler Jones, Chiara Melloni, Kenneth W. Mahaffey, Karen P. Alexander, Renato D. Lopes
Effects of synbiotic supplementation on gut microbiome, serum level of TNF-α, and expression of microRNA-126 and microRNA-146a in patients with type 2 diabetes mellitus: study protocol for a double-blind controlled randomized clinical trial
Fahime Zeinali, Seyed Mohsen Aghaei Zarch, Mohammad Yahya Vahidi Mehrjardi, Seyed Mehdi Kalantar, Alireza Jahan-mihan, Elham Karimi-Nazari, Hossein Fallahzadeh, Mahdieh Hosseinzadeh-Shamsi-Anar, Masoud Rahmanian, Mohammad Reza Fazeli, Hassan Mozaffari-Khosravi
Goal-Focused Emotion-Regulation Therapy (GET) for young adult survivors of testicular cancer: a pilot randomized controlled trial of a biobehavioral intervention protocol
Michael A. Hoyt, Ashley Wei-Ting Wang, Sean J. Ryan, Elizabeth C. Breen, Jennifer S. Cheavens, Christian J. Nelson
Response to the letter on “Comments to ‘PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial’ by Janusz Strzelczyk”
T. Auer, D. Kniepeiss, P. Schemmer
COVID-19 randomised trial protocols: rapid publication without barriers
Shaun Treweek, Peter Jüni, Tianjing Li, Jonathan Collin, Matthias Briel, An-Wen Chan, Karla Hemming, William J. Meurer, Matthew R. Sydes, Jeremy M. Grimshaw
Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II superiority clinical trial
D. Molina-Morant, M. L. Fernández, P. Bosch-Nicolau, E. Sulleiro, M. Bangher, F. Salvador, A. Sanchez-Montalva, A. L. P. Ribeiro, A. M. B. de Paula, S. Eloi, R. Correa-Oliveira, J. C. Villar, S. Sosa-Estani, I. Molina
Can hypnosis and virtual reality reduce anxiety, pain and fatigue among patients who undergo cardiac surgery: a randomised controlled trial
Floriane Rousseaux, Marie-Elisabeth Faymonville, Anne-Sophie Nyssen, Nadia Dardenne, Didier Ledoux, Paul B. Massion, Audrey Vanhaudenhuyse
An optimised dosing regimen versus a standard dosing regimen of vancomycin for the treatment of late onset sepsis due to Gram-positive microorganisms in neonates and infants aged less than 90 days (NeoVanc): study protocol for a randomised controlled trial
Louise F. Hill, Mark A. Turner, Irja Lutsar, Paul T. Heath, Pollyanna Hardy, Louise Linsell, Evelyne Jacqz-Aigrain, Emmanuel Roilides, Mike Sharland, Carlo Giaquinto, Davide Bilardi, Mike Sharland, Paul T. Heath, Louise F. Hill, Timothy Planche, Tatiana Munera Huertas, Mark A. Turner, William Hope, Irja Lutsar, Emmanuel Roilides, Evelyne Jacqz-Aigrain, Wei Zhao, Louise Linsell, Peter Ghazal, Andrea Dotta, Javier de la Cruz, Clara Alonso Díaz, Susan Conroy, Louise Rawcliffe, Donato Bonifazi, Cristina Manfredi, Mariagrazia Felisi
Bronchiectasis Information and Education: a randomised, controlled feasibility trial
Katy L. M. Hester, Vicky Ryan, Julia Newton, Tim Rapley, Anthony De Soyza
Protocol for a stepped-wedge, cluster randomized controlled trial of the LifeSpan suicide prevention trial in four communities in New South Wales, Australia
Fiona Shand, Michelle Torok, Nicole Cockayne, Philip J. Batterham, Alison L. Calear, Andrew Mackinnon, Dean Martin, Isabel Zbukvic, Katherine Mok, Nicola Chen, Lauren McGillivray, Matthew Phillips, Henry Cutler, Brian Draper, Grant Sara, Helen Christensen
The clinical and cost-effectiveness of a Victim Improvement Package (VIP) for the reduction of chronic symptoms of depression or anxiety in older victims of common crime (the VIP trial): study protocol for a randomised controlled trial
Marc Serfaty, Trefor Aspden, Jessica Satchell, Anthony Kessel, Gloria Laycock, Chris R. Brewin, Marta Buszewicz, Aidan O’Keeffe, Rachael Hunter, Gerard Leavey, Jon Cuming-Higgs, Vari Drennan, Monica Riveros, David Andrew, Martin Blanchard
Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): a multicenter stepped-wedge cluster randomized controlled trial
T. M. Mackay, F. J. Smits, A. E. J. Latenstein, A. Bogte, B. A. Bonsing, H. Bos, K. Bosscha, L. A. A. Brosens, L. Hol, O. R. C. Busch, G. J. Creemers, W. L. Curvers, M. den Dulk, S. van Dieren, L. M. J. W. van Driel, S. Festen, E. J. M. van Geenen, L. G. van der Geest, D. J. A. de Groot, J. W. B. de Groot, N. Haj Mohammad, B. C. M. Haberkorn, J. T. Haver, E. van der Harst, G. J. M. Hemmink, I. H. de Hingh, C. Hoge, M. Y. V. Homs, N. C. van Huijgevoort, M. A. J. M. Jacobs, E. D. Kerver, M. S. L. Liem, M. Los, H. Lubbinge, S. A. C. Luelmo, V. E. de Meijer, L. Mekenkamp, I. Q. Molenaar, M. G. H. van Oijen, G. A. Patijn, R. Quispel, L. B. van Rijssen, T. E. H. Römkens, H. C. van Santvoort, J. M. J. Schreinemakers, H. Schut, T. Seerden, M. W. J. Stommel, A. J. ten Tije, N. G. Venneman, R. C. Verdonk, J. Verheij, F. G. I. van Vilsteren, J. de Vos-Geelen, A. Vulink, C. Wientjes, F. Wit, F. J. Wessels, B. Zonderhuis, C. H. van Werkhoven, J. E. van Hooft, C. H. J. van Eijck, J. W. Wilmink, H. W. M. van Laarhoven, M. G. Besselink
Mechanisms of change in brief treatments for borderline personality disorder: a protocol of a randomized controlled trial
Ueli Kramer, Loris Grandjean, Hélène Beuchat, Stéphane Kolly, Philippe Conus, Yves de Roten, Bogdan Draganski, Jean-Nicolas Despland
Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial
Nancy A. Rigotti, Kristina Schnitzer, Esa M. Davis, Susan Regan, Yuchiao Chang, Jennifer H. K. Kelley, Anna E. Notier, Karen Gilliam, Antoine Douaihy, Douglas E. Levy, Daniel E. Singer, Hilary A. Tindle
Hypotheses, rationale, design, and methods for prognostic evaluation of a randomized comparison between patients with coronary artery disease associated with ischemic cardiomyopathy who undergo medical or surgical treatment: MASS-VI (HF)
Paulo Cury Rezende, Whady Hueb, Edimar Alcides Bocchi, Michael Farkouh, Carlos Vicente Serrano Junior, Eduardo Gomes Lima, Expedito Eustáquio Ribeiro Silva, Luis Alberto Oliveira Dallan, Fabio Antonio Gaiotto, Cibele Larrosa Garzillo, Carlos Eduardo Rochitte, Cesar Higa Nomura, Thiago Luis Scudeler, Paulo Rogério Soares, Fabio Biscegli Jatene, José Antonio Franchini Ramires, Roberto Kalil Filho
Combined extracorporeal shock wave lithotripsy and endoscopic treatment for pain in chronic pancreatitis (SCHOKE trial): study protocol for a randomized, sham-controlled trial
Søren S. Olesen, Asbjørn M. Drewes, Rajesh Gaud, Manu Tandan, Sundeep Lakhtakia, Mohan Ramchandani, G. V. Rao, D. Nageshwar Reddy, Rupjyoti Talukdar
Correction to: Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial
Marijke Dieltjens, Marc J. Braem, Sara Op de Beeck, Anneclaire V. M. T. Vroegop, Elahe Kazemeini, Eli Van de Perck, Jolien Beyers, Chloé Kastoer, Kristien Wouters, Marc Willemen, Johan A. Verbraecken, Olivier M. Vanderveken
Supporting caregivers of veterans with Alzheimer’s disease and traumatic brain injury: study protocol for a randomized controlled trial
Jennifer L. Carnahan, Katherine S. Judge, Joanne K. Daggy, James E. Slaven, Nicki Coleman, Emily L. Fortier, Christopher Suelzer, Nicole R. Fowler
Effectiveness of steroids versus placebo in preventing upper airway obstruction after extubation in critically ill children: rationale and design of a multicentric, double-blind, randomized study
Gema Manrique, Laura Butragueño-Laiseca, Rafael González, Corsino Rey, Zuriñe Martínez de Compañon, Javier Gil, Antonio Rodríguez-Núñez, Cecilia Martínez, Silvia Manrique, Jesús López-Herce
Discontinuing statins or not in the elderly? Study protocol for a randomized controlled trial
Fabrice Bonnet, Antoine Bénard, Pierre Poulizac, Mélanie Afonso, Aline Maillard, Francesco Salvo, Driss Berdaï, Nathalie Salles, Nicolas Rousselot, Sébastien Marchi, Nathalie Hayes, Jean-Philippe Joseph
Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises in Nepal: study protocol for a cluster randomized controlled trial
Edith van’t Hof, Manaswi Sangraula, Nagendra P. Luitel, Elizabeth L. Turner, Kedar Marahatta, Mark van Ommeren, Pragya Shrestha, Richard Bryant, Brandon A. Kohrt, Mark J. D. Jordans
ATLANTIS: a randomised multi-arm phase II biomarker-directed umbrella screening trial of maintenance targeted therapy after chemotherapy in patients with advanced or metastatic urothelial cancer
Ben Fulton, Robert Jones, Thomas Powles, Simon Crabb, James Paul, Alison Birtle, Simon Chowdhury, Syed Hussain, Anna Morris, Eileen Soulis, Paula Morrison
Correction to: Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial
A. Hamish R. W. Simpson, Colin R. Howie, Elaine Kinsella, David F. Hamilton, Philip G. Conaghan, Catherine Hankey, Sharon Anne Simpson, Anna Bell-Higgs, Peter Craig, Nicholas D. Clement, Catriona Keerie, Sarah R. Kingsbury, Anthony R. Leeds, Hazel M. Ross, Hemant G. Pandit, Chris Tuck, John Norrie
Lifestyle changes and glycemic control in type 1 diabetes mellitus: a trial protocol with factorial design approach
Sobiya Sawani, Amna Rehana Siddiqui, Syed Iqbal Azam, Khadija Humayun, Asma Ahmed, Aysha Habib, Sabahat Naz, Mayera Tufail, Romaina Iqbal
Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): study protocol for a randomised controlled feasibility trial
Laura L. Oakley, Moji Awogbade, Sarah Brien, Annette Briley, Maria Chorozoglou, Emma Drasar, Jemma Johns, Elizabeth Rhodes, Vicky Robinson, Paul Seed, Joseph Sharif, Claire Singh, Paul Telfer, Hilary Thompson, Ingrid Watt-Coote, Jo Howard, Eugene Oteng-Ntim
Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention
Arabella Scantlebury, Sarah Cockayne, Caroline Fairhurst, Sara Rodgers, David Torgerson, Catherine Hewitt, Joy Adamson
Design and implementation of an intelligent monitoring system for household added salt consumption in China based on a real-world study: a randomized controlled trial
Jinli Xian, Mao Zeng, Rui Zhu, Zhengjie Cai, Zumin Shi, Abu S. Abdullah, Yong Zhao
Letter on Update to the Vitamin C, Thiamine, and Steroids in Sepsis (VICTAS) Protocol
Mark A. Frommelt, Pierre Kory, Micah T. Long
In response: Letter on update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol
Christopher J. Lindsell, Anna McGlothlin, Samuel Nwosu, Todd W. Rice, Alex Hall, Gordon R. Bernard, Laurence W. Busse, E. Wesley Ely, Alpha A. Fowler, David F. Gaieski, Jeremiah S. Hinson, Michael H. Hooper, James C. Jackson, Gabor D. Kelen, Mark Levine, Greg S. Martin, Richard E. Rothman, Jonathan E. Sevransky, Kert Viele, David W. Wright, David N. Hager
Durvalumab in frail and elderly patients with stage four non-small cell lung cancer: Study protocol of the randomized phase II DURATION trial
Jonas Kuon, Adriane Hommertgen, Johannes Krisam, Felix Lasitschka, Albrecht Stenzinger, Miriam Blasi, Farastuk Bozorgmehr, Martin Maenz, Meinhard Kieser, Marc Schneider, Michael Thomas
Design and rationale of a randomized control trial testing the effectiveness of combined therapy with STAtin plus FENOfibrate and statin alone in non-diabetic, combined dyslipidemia patients with non-intervened intermediate coronary artery disease - STAFENO study
Taek-Geun Kwon, Albert Youngwoo Jang, Sang Wook Kim, Young Joon Hong, Jang-Ho Bae, Sung Yun Lee, Sang-Hyun Kim, Seung Hwan Han
A double-blind, randomized, crossover trial protocol of whole hemp seed protein and hemp seed protein hydrolysate consumption for hypertension
Maryam Samsamikor, Dylan Mackay, Rebecca C. Mollard, Rotimi E. Aluko
A randomised controlled trial of therapist-assisted online psychological therapies for posttraumatic stress disorder (STOP-PTSD): trial protocol
Anke Ehlers, Jennifer Wild, Emma Warnock-Parkes, Nick Grey, Hannah Murray, Alice Kerr, Alexander Rozental, Esther T. Beierl, Apostolos Tsiachristas, Rafael Perera-Salazar, Gerhard Andersson, David M. Clark
Pilot test of an online training module on near-infrared spectroscopy monitoring for the randomised clinical trial SafeBoosC-III
Mathias Lühr Hansen, Marie Isabel Rasmussen, Snorre Rubin, Adelina Pellicer, Guoqiang Cheng, Xin Xu, Yin Zhaoqing, Vibeke Zoffmann, Gorm Greisen
Efficacy of digital cognitive behavioural therapy for symptoms of generalised anxiety disorder: a study protocol for a randomised controlled trial
J. Gu, C. B. Miller, A. L. Henry, C. A. Espie, M. L. Davis, R. Stott, R. Emsley, J. A. J. Smits, M. Craske, K. E. A. Saunders, G. Goodwin, J. R. Carl
Proactive versus standard support of labour in nulliparous women; study protocol for a randomized, controlled trial
Møyfrid Brenne Fehn, Raija Dahlø, Renate Nielsen, Ingebjørg Laache, Eszter Vanky
Effectiveness of a multi-level intervention to reduce men’s perpetration of intimate partner violence: a cluster randomised controlled trial
Nicola J. Christofides, Abigail M. Hatcher, Dumisani Rebombo, Ruari-Santiago McBride, Shehnaz Munshi, Angelica Pino, Nada Abdelatif, Dean Peacock, Jonathan Levin, Rachel K. Jewkes
Acupressure to improve sleep quality of older people in residential aged care: a randomised controlled trial protocol
Nant Thin Thin Hmwe, Graeme Browne, Lyndall Mollart, Viv Allanson, Sally Wai-Chi Chan
Intense versus standard regimens of intermittent occlusion therapy for unilateral moderate amblyopia in children: study protocol for a randomized controlled trial
Jingyun Wang, Ayesha Malik, Jing Jin, Yi Pang, Kelly Yin, Megan Allen, Adriana Grigorian, Brandy Scombordi, Joann Bailey, Saeed Aljohani, Katharine Funari, Ruth Shoge, Siva Meiyeppen, Jenny Myung, Ajay Soni, Daniel E. Neely
Protocol for a randomized multicenter study for isolated skin vasculitis (ARAMIS) comparing the efficacy of three drugs: azathioprine, colchicine, and dapsone
Robert G. Micheletti, Christian Pagnoux, Roy N. Tamura, Peter C. Grayson, Carol A. McAlear, Renee Borchin, Jeffrey P. Krischer, Peter A. Merkel
The MiLES intervention targeting employers to promote successful return to work of employees with cancer: design of a pilot randomised controlled trial
Michiel A. Greidanus, Angela G. E. M. de Boer, Angelique E. de Rijk, Monique H. W. Frings-Dresen, Sietske J. Tamminga
Relapse after conservative surgery combined with triptorelin acetate versus conservative surgery only in women with focal adenomyosis: study protocol for a multicenter, prospective, randomized controlled trial
Wenwen Wang, Xiangyi Ma, Wei Zhang, Zhiying Li, Yan Wang, Zhiying Yu, Chunlian Zhang, Li Hong, Ruoyu Luo, Hui Xing, Wuliang Wang, Qingfen Yue, Jia Wei, Minli Zhang, Shixuan Wang
Effect of nutritional interventions on discharged older patients: study protocol for a randomized controlled trial
Tina Munk, Jonas Anias Svendsen, Anne Wilkens Knudsen, Tanja Bak Østergaard, Anne Marie Beck
Peer support during in vivo exposure homework to reverse attrition from prolonged exposure therapy for posttraumatic stress disorder (PTSD): description of a randomized controlled trial
Melba A. Hernandez-Tejada, Wendy Muzzy, Matthew Price, Stephanie Hamski, Stephanie Hart, Edna Foa, Ron Acierno
Lay-therapist-delivered, low-intensity, psychosocial intervention for refugees and asylum seekers (PROSPER): protocol for a pilot randomised controlled trial
Rebecca Rawlinson, Rabeea’h W. Aslam, Girvan Burnside, Anna Chiumento, Malena Eriksson-Lee, Amy Humphreys, Naila Khan, Daniel Lawrence, Rachel McCluskey, Annette Mackinnon, Lois Orton, Atif Rahman, Ewan Roberts, Anna Rosala-Hallas, Rhiannon Tudor Edwards, Philomene Uwamaliya, Ross G. White, Eira Winrow, Christopher Dowrick
Increasing uptake of evidence-based screening services though a community health worker-delivered multimodality program: study protocol for a randomized pragmatic trial
Olveen Carrasquillo, Julia Seay, Vasanti Jhaveri, Timothy Long, Sonjia Kenya, Emmanuel Thomas, Daniel Sussman, Dinah Trevil, Tulay Koru-Sengul, Erin Kobetz
Effects of perioperative enhanced recovery after surgery pathway management versus traditional management on the clinical outcomes of laparoscopic-assisted radical resection of distal gastric cancer: study protocol for a randomized controlled trial
Yulong Tian, Shougen Cao, Leping Li, Qingsi He, Lijian Xia, Lixin Jiang, Yinlu Ding, Xinjian Wang, Hao Wang, Weizheng Mao, Xizeng Hui, Yiran Shi, Huanhu Zhang, Xianqun Chu, Henrik Kehlet, Yanbing Zhou
Efficacy and safety of Shengjiang Xiexin decoction in prophylaxis of chemotherapy-related diarrhea in small cell lung cancer patients: study protocol for a multicenter randomized controlled trial
Chao Deng, Yanni Lou, Yu Gao, Bo Deng, Fei Su, Liqun Jia
Peer support for people with severe mental illness versus usual care in high-, middle- and low-income countries: study protocol for a pragmatic, multicentre, randomised controlled trial (UPSIDES-RCT)
Galia S. Moran, Jasmine Kalha, Annabel S. Mueller-Stierlin, Reinhold Kilian, Silvia Krumm, Mike Slade, Ashleigh Charles, Candelaria Mahlke, Rebecca Nixdorf, David Basangwa, Juliet Nakku, Richard Mpango, Grace Ryan, Donat Shamba, Mary Ramesh, Fileuka Ngakongwa, Alina Grayzman, Soumitra Pathare, Benjamin Mayer, Bernd Puschner
Evaluation of a ketogenic diet for improvement of neurological recovery in individuals with acute spinal cord injury: study protocol for a randomized controlled trial
Aynur Demirel, Jia Li, Casey Morrow, Stephen Barnes, Jan Jansen, Barbara Gower, Keneshia Kirksey, David Redden, Ceren Yarar-Fisher
The HOME Study: Statistical and economic analysis plan for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the time spent in hospital by older acute hospital inpatients
Nicholas Magill, Ian R. White, Jane Walker, Katy Burke, Mark Toynbee, Maike van Niekerk, Fan Yang, Simon Walker, Mark Sculpher, Michael Sharpe, Chris Frost
Low-Intensity Guided Help Through Mindfulness (LIGHTMIND): study protocol for a randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help to supported cognitive behavioural therapy self-help for adults experiencing depression
Clara Strauss, Amy Arbon, Michael Barkham, Sarah Byford, Rebecca Crane, Richard de Visser, Margaret Heslin, Anna-Marie Jones, Fergal Jones, Laura Lea, Glenys Parry, Claire Rosten, Kate Cavanagh
Correction to: Comparative effectiveness of post-discharge strategies for hospitalized smokers: Study protocol for the Helping HAND 4 randomized controlled trial
Nancy A. Rigotti, Kristina Schnitzer, Esa M. Davis, Susan Regan, Yuchiao Chang, Jennifer H. K. Kelley, Anna E. Notier, Karen Gilliam, Antoine Douaihy, Douglas E. Levy, Daniel E. Singer, Hilary A. Tindle
A study protocol for a cluster randomised controlled trial on mindfulness-based stress reduction: studying effects of mindfulness-based stress reduction and an additional organisational health intervention on mental health and work-related perceptions of teachers in Dutch secondary vocational schools
Math Janssen, Yvonne Heerkens, Beatrice Van der Heijden, Hubert Korzilius, Pascale Peters, Josephine Engels
Implementation of an intervention to improve the adoption of asthma self-management practices in Peru: Asthma Implementation Research (AIRE) randomized trial study protocol
Elisa D. Romani, Trishul Siddharthan, Nair Lovatón, Carol C. Alvítez-Luna, Oscar Flores-Flores, Suzanne L. Pollard
Does asymmetry in patient recruitment in large critical care trials follow the Pareto principle?
Mahesh Ramanan, Laurent Billot, Dorrilyn Rajbhandari, John Myburgh, Simon Finfer, Rinaldo Bellomo, Balasubramanian Venkatesh
The effect of luseogliflozin on bone microarchitecture in older patients with type 2 diabetes: study protocol for a randomized controlled pilot trial using second-generation, high-resolution, peripheral quantitative computed tomography (HR-pQCT)
Ai Haraguchi, Riyoko Shigeno, Ichiro Horie, Shimpei Morimoto, Ayako Ito, Ko Chiba, Yurika Kawazoe, Shigeki Tashiro, Junya Miyamoto, Shuntaro Sato, Hiroshi Yamamoto, Makoto Osaki, Atsushi Kawakami, Norio Abiru
Is natural (6S)-5-methyltetrahydrofolic acid as effective as synthetic folic acid in increasing serum and red blood cell folate concentrations during pregnancy? A proof-of-concept pilot study
Kelsey M. Cochrane, Chantal Mayer, Angela M. Devlin, Rajavel Elango, Jennifer A. Hutcheon, Crystal D. Karakochuk
Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): study protocol for a randomized controlled trial
Niti Shrestha, Liang Wu, Xiaodi Wang, Wenqing Jia, Fang Luo
Neurofeedback for tinnitus: study protocol for a randomised controlled trial assessing the specificity of an alpha/delta neurofeedback training protocol in alleviating both sound perception and psychological distress in a cohort of chronic tinnitus sufferers
Martin Jensen, Eva Hüttenrauch, Jennifer Schmidt, Gerhard Andersson, Mira-Lynn Chavanon, Cornelia Weise
Electronic pillbox-enabled self-administered therapy versus standard directly observed therapy for tuberculosis medication adherence and treatment outcomes in Ethiopia (SELFTB): protocol for a multicenter randomized controlled trial
Tsegahun Manyazewal, Yimtubezinash Woldeamanuel, David P. Holland, Abebaw Fekadu, Henry M. Blumberg, Vincent C. Marconi
Where do we go from here? – Opportunities and barriers to the career development of trial managers: a survey of UK-based trial management professionals
Eleanor Mitchell, Kirsteen Goodman, Suzanne Hartley, Helen Hickey, Alison M. McDonald, Helen M. Meadows, Shelley Rhodes, Jodi Taylor, Natalie Wakefield, Barbara Farrell
Opposing needling for analgesia and rehabilitation after unilateral total knee arthroplasty: a randomized, sham-controlled trial protocol
Hai Huang, Xiuling Song, Ling Zhao, Lin Zheng, Lianbo Xiao, Yuelai Chen
Graphing and reporting heterogeneous treatment effects through reference classes
James A. Watson, Chris C. Holmes
Educational strategy for the development of skills in exchange transfusion: a randomized clinical trial protocol
María José Maldonado, Sergio Iván Agudelo, Juan David Suarez, Oscar Gamboa
Correction to: Update on the EFFECTS study of fluoxetine for stroke recovery: a randomised controlled trial in Sweden
Erik Lundström, Eva Isaksson, Per Näsman, Per Wester, Björn Mårtensson, Bo Norrving, Håkan Wallén, Jörgen Borg, Martin Dennis, Gillian Mead, Graeme J. Hankey, Maree L. Hackett, Katharina S. Sunnerhagen
Care after pancreatic resection according to an algorithm for early detection and minimally invasive management of pancreatic fistula versus current practice (PORSCH-trial): design and rationale of a nationwide stepped-wedge cluster-randomized trial
F. Jasmijn Smits, Anne Claire Henry, Casper H. van Eijck, Marc G. Besselink, Olivier R. Busch, Mark Arntz, Thomas L. Bollen, Otto M. van Delden, Daniel van den Heuvel, Christiaan van der Leij, Krijn P. van Lienden, Adriaan Moelker, Bert A. Bonsing, Inne H. M. Borel Rinkes, Koop Bosscha, R. M. van Dam, Sebastiaan Festen, B. Groot Koerkamp, Erwin van der Harst, Ignace H. de Hingh, Geert Kazemier, Mike Liem, B. Marion van der Kolk, Vincent E. de Meijer, Gijs A. Patijn, Daphne Roos, Jennifer M. Schreinemakers, Fennie Wit, C. Henri van Werkhoven, I. Quintus Molenaar, Hjalmar C. van Santvoort
Survive and Thrive in Brazil: The Boa Vista Early Childhood Program: study protocol of a stepped-wedge, randomized controlled trial
Alexandra Brentani, Ana Paula Scolezze Ferrer, Luana Bessa, Susan Chang, Susan Walker, Christine Powell, Jena Hamadani, Sandra Grisi, Günther Fink
Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD)
Toshinari Yamashita, Norikazu Masuda, Shigehira Saji, Kazuhiro Araki, Yoshinori Ito, Toshimi Takano, Masato Takahashi, Junji Tsurutani, Kei Koizumi, Masahiro Kitada, Yasuyuki Kojima, Yasuaki Sagara, Hiroshi Tada, Tsutomu Iwasa, Takayuki Kadoya, Tsuguo Iwatani, Hiroki Hasegawa, Satoshi Morita, Shinji Ohno
Usual care including home exercise with versus without spa therapy for chronic low back pain: protocol for the LOMBATHERM’ study, a multicentric randomised controlled trial
Romain Forestier, Carey Suehs, Alain Françon, Marc Marty, Stéphane Genevay, Jérémie Sellam, Claire Chauveton, Fatma Begüm Erol Forestier, Nicolas Molinari
Retaining participants in community-based health research: a case example on standardized planning and reporting
Nicole L. A. Catherine, Rosemary Lever, Lenora Marcellus, Corinne Tallon, Debbie Sheehan, Harriet MacMillan, Andrea Gonzalez, Susan M. Jack, Charlotte Waddell
An antibiotic stewardship programme to reduce inappropriate antibiotic prescribing for acute respiratory infections in rural Chinese primary care facilities: study protocol for a clustered randomised controlled trial
Chao Zhuo, Xiaolin Wei, Zhitong Zhang, Joseph Paul Hicks, Jinkun Zheng, Zhixu Chen, Victoria Haldane, John Walley, Yubao Guan, Hongyan Xu, Nanshan Zhong
Normalization of a conversation tool to promote shared decision making about anticoagulation in patients with atrial fibrillation within a practical randomized trial of its effectiveness: a cross-sectional study
Gabriela Spencer-Bonilla, Anjali Thota, Paige Organick, Oscar J. Ponce, Marleen Kunneman, Rachel Giblon, Megan E. Branda, Angela L. Sivly, Emma Behnken, Carl R. May, Victor M. Montori, Victor Montori, Megan E. Branda, Juan Pablo Brito, Marleen Kunneman, Ian Hargraves, Angela L. Sivly, Kirsten Fleming, Bruce Burnett, Mark Linzer, Haeshik Gorr, Elizabeth Jackson, Erik Hess, Takeki Suzuki, James Hamilton IV, Peter A. Noseworthy, Haeshik Gorr, Alexander Haffke, Mark Linzer, Jule Muegge, Sara Poplau, Benjamin Simpson, Miamoua Vang, Mike Wambua, Joel Anderson, Emma Behnken, Fernanda Bellolio, Renee Cabalka, Michael Ferrara, Rachel Giblon, Jonathan Inselman, Annie LeBlanc, Peter Noseworthy, Marc Olive, Paige Organick, Nilay Shah, Gabriela Spencer-Bonilla, Amy Stier, Anjali Thota, Henry Ting, Derek Vanmeter, Claudia Zeballos-Palacios, Park Nicollet-HealthPartners, Carol Abullarde, Lisa Harvey, Shelly Keune, Timothy Smith, Shannon Stephens, Bryan Barksdale, Theresa Hickey, Roma Peters, Memrie Price, Connie Watson, Douglas Wolfe, Gordon Guyatt, Brian Haynes, George Tomlinson, Paul Daniels, Bernard Gersh, Thomas Jaeger, Robert McBane
Modified Sijunzi decoction in the treatment of ulcerative colitis in the remission phase: study protocol for a series of N-of-1 double-blind, randomised controlled trials
Yi-ming Chen, Jie-min Deng, Yi Wen, Bin Chen, Jiang-tao Hou, Bin Peng, Shi-jing Zhang, Hong Mi, Qi-long Jiang, Xia-lin Wu, Feng-bin Liu, Xin-lin Chen
Clinical efficacy of potassium canreonate-canrenone in sinus rhythm restoration among patients with atrial fibrillation - a protocol of a pilot, randomized, double -blind, placebo-controlled study (CANREN-AF trial)
Rafał Dąbrowski, Paweł Syska, Justyna Mączyńska, Michał Farkowski, Stefan Sawicki, Agata Kubaszek-Kornatowska, Piotr Michałek, Ilona Kowalik, Hanna Szwed, Tomasz Hryniewiecki
Access to routinely collected health data for clinical trials – review of successful data requests to UK registries
Sarah Lensen, Archie Macnair, Sharon B. Love, Victoria Yorke-Edwards, Nurulamin M. Noor, Meredith Martyn, Alexandra Blenkinsop, Carlos Diaz-Montana, Graham Powell, Elizabeth Williamson, James Carpenter, Matthew R. Sydes
Individualized treatment for acute Achilles tendon rupture based on the Copenhagen Achilles Rupture Treatment Algorithm (CARTA): a study protocol for a multicenter randomized controlled trial
Maria Swennergren Hansen, Marianne Toft Vestermark, Per Hölmich, Morten Tange Kristensen, Kristoffer Weisskirchner Barfod
The effect of supplemental oxygen on perioperative brain natriuretic peptide concentration in cardiac risk patients – a protocol for a prosprective randomized clinical trial
Christian Reiterer, Barbara Kabon, Markus Falkner von Sonnenburg, Patrick Starlinger, Alexander Taschner, Oliver Zotti, Julius Goshin, Gregor Drlicek, Edith Fleischmann
Propranolol for familial cerebral cavernous malformation (Treat_CCM): study protocol for a randomized controlled pilot trial
Silvia Lanfranconi, Elisa Scola, Giulio Andrea Bertani, Barbara Zarino, Roberto Pallini, Giorgio d’Alessandris, Emanuela Mazzon, Silvia Marino, Maria Rita Carriero, Emma Scelzo, Giuseppe Faragò, Marco Castori, Carmela Fusco, Antonio Petracca, Leonardo d’Agruma, Laura Tassi, Piergiorgio d’Orio, Maria Grazia Lampugnani, Enrico Bjorn Nicolis, Antonella Vasamì, Deborah Novelli, Valter Torri, Jennifer Marie Theresia Anna Meessen, Rustam Al-Shahi Salman, Elisabetta Dejana, Roberto Latini, R. Pallini, G. d’Alessandris, F. Pignotti, C. Sturiale, A. Albanese, S. Lanfranconi, E. Scola, G. A. Bertani, B. Zarino, G. Valcamonica, D. Ronchi, M. R. Carriero, E. Scelzo, G. Faragò, S. Pogliani, U. de Grazia, C. Bossi, E. Mazzon, S. Marino, R. Ciurleo, C. Fusco, A. Petracca, L. D’Agruma, P. Raggi, A. Simeone, P. d’Orio, M. G. Lampugnani, E. Dejana, E. B. Nicolis, A. Vasamì, D. Novelli, V. Torri, J. M. T. A. Meessen, R. Latini, G. Balconi, A. Foresta, M. G. Buratti, M. Carrara, M. L. Ojeda Fernandez, R. Al-Shahi Salman, R. Treglia, A. P. Maggioni, E. Beghi, M. Tettamanti, C. Regna-Gladin, A. Prelle, M. Mangiavacchi, Marco Poloni, F. Lazzaroni, M. Malinverno, D. Novelli, E. B. Nicolis, M. G. Buratti, A. Vasami, C. Ungaro, F. Raucci, M. Castori, L. Tassi
Reducing sitting at work: process evaluation of the SMArT Work (Stand More At Work) intervention
Stuart J. H. Biddle, Sophie E. O’Connell, Melanie J. Davies, David Dunstan, Charlotte L. Edwardson, Dale W. Esliger, Laura J. Gray, Thomas Yates, Fehmidah Munir
Effects of multidomain versus single-domain training on executive control and memory in older adults: study protocol for a randomized controlled trial
Soledad Ballesteros, Jennifer A. Rieker, Julia Mayas, Antonio Prieto, Pilar Toril, María Pilar Jiménez, José Manuel Reales
Comparison of the clinical and cost effectiveness of two management strategies (rehabilitation versus surgical reconstruction) for non-acute anterior cruciate ligament (ACL) injury: study protocol for the ACL SNNAP randomised controlled trial
Loretta Davies, Jonathan Cook, Jose Leal, Carlos Morgado Areia, Beverly Shirkey, William Jackson, Helen Campbell, Heidi Fletcher, Andrew Carr, Karen Barker, Sarah E. Lamb, Paul Monk, Sean O’Leary, Fares Haddad, Chris Wilson, Andrew Price, David Beard
Effect of acupuncture and its influence on cerebral activity in patients with persistent asthma: study protocol for a randomized controlled clinical trial
Siyi Yu, Xiaohui Dong, Ruirui Sun, Zhaoxuan He, Chuantao Zhang, Mei Chen, Xiaojuan Hong, Lei Lan, Fang Zeng
OPTimal IMAging strategy in patients suspected of non-traumatic pulmonary disease at the emergency department: chest X-ray or ultra-low-dose chest CT (OPTIMACT) trial—statistical analysis plan
Maadrika M. N. P. Kanglie, Shandra Bipat, Inge A. H. van den Berk, Tjitske S. R. van Engelen, Marcel G. W. Dijkgraaf, Jan M. Prins, Jaap Stoker, Patrick M. M. Bossuyt
Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial
Zeng Congcong, Liu Xi, Hu Lufeng, Feng Yuan, Xia Nengzhi, Zeng Haihuan, Luo Lin, Ye Ren, Yuan Zhengzhong
Steps to recovery: body weight-supported treadmill training for critically ill patients: a randomized controlled trial
Robin C. H. Kwakman, Juultje Sommers, Janneke Horn, Frans Nollet, Raoul H. H. Engelbert, Marike van der Schaaf
Efficacy and safety of Onkyeong-tang in treating cold hypersensitivity in the feet of Korean women: protocol for a double-blind, randomized, placebo-controlled, parallel-group, multicenter clinical study
Kyou-Young Lee, In-Sik Han, Ho-Yeon Go, Dong-Nyung Lee, Jun-Sang Yu, Seung-Ho Sun
Effect of an interprofessional care concept on the hospitalization of nursing home residents: study protocol for a cluster-randomized controlled trial
Alexandra Piotrowski, Martha Meyer, Iris Burkholder, Dagmar Renaud, Markus Alexander Müller, Thorsten Lehr, Sonja Laag, Joachim Meiser, Lisa Manderscheid, Juliane Köberlein-Neu
Efficacy of extended infusion of β-lactam antibiotics for the treatment of febrile neutropenia in haematologic patients: protocol for a randomised, multicentre, open-label, superiority clinical trial (BEATLE)
J. Laporte-Amargos, C. Gudiol, M. Arnan, P. Puerta-Alcalde, F. Carmona-Torre, M. Huguet, A. Albasanz-Puig, R. Parody, C. Garcia-Vidal, J. L. del Pozo, M. Batlle, C. Tebé, R. Rigo-Bonnin, C. Muñoz, A. Padullés, F. Tubau, S. Videla, A. Sureda, J. Carratalà
The design and statistical aspects of VIETNARMS: a strategic post-licensing trial of multiple oral direct-acting antiviral hepatitis C treatment strategies in Vietnam
Leanne McCabe, Ian R. White, Nguyen Van Vinh Chau, Eleanor Barnes, Sarah L. Pett, Graham S. Cooke, A. Sarah Walker, Eleanor Barnes, Graham S. Cooke, Jeremy N. Day, Nguyen Thanh Dung, Barnaby Flower, Tim Hallett, Le Manh Hung, Evelyne Kestelyn, Dao Bach Khoa, Leanne McCabe, Sarah L. Pett, Le Thanh Phuong, Motiur Rahman, Joel Tarning, Hugo C. Turner, Guy E. Thwaites, Nguyen Van Vinh Chau, A. Sarah Walker, Nicholas J. White
Supervised exercise protocol for lower limbs in subjects with chronic venous disease: an evaluator-blinded, randomized clinical trial
Esther Fernandes Tinoco Volpe, Vanessa R. Resqueti, Ana Aline Marcelino da Silva, Lucien Peroni Gualdi, Guilherme A. F. Fregonezi
Design and rationale of the Danish trial of beta-blocker treatment after myocardial infarction without reduced ejection fraction: study protocol for a randomized controlled trial
Anna Meta Dyrvig Kristensen, Ann Bovin, Ann Dorthe Zwisler, Charlotte Cerquira, Christian Torp-Pedersen, Hans Erik Bøtker, Ida Gustafsson, Karsten Tange Veien, Kristian Korsgaard Thomsen, Michael Hecht Olsen, Mogens Lytken Larsen, Olav Wendelboe Nielsen, Per Hildebrandt, Sussie Foghmar, Svend Eggert Jensen, Theis Lange, Thomas Sehested, Tomas Jernberg, Dan Atar, Borja Ibanez, Eva Prescott
Efficacy of Liu-zi-jue in Patients with 2019 Novel Coronavirus Pneumonia (COVID-19): structured summary of a study protocol for a randomized controlled trial
Shuaipan Zhang, Zhizhen Lv, Qingguang Zhu, Wuquan Sun, Fei Yao, Lei Fang, Yanbin Cheng, Zhiwei Wu, Min Fang
The Disruptive bEhavior manageMEnt ANd prevention in hospitalized patients using a behaviORal intervention team (DEMEANOR) study protocol: a pragmatic, cluster, crossover trial
Jay Morrison, Michele Hasselblad, Ruth Kleinpell, Reagan Buie, Deborah Ariosto, Erin Hardiman, Stephen W. Osborn, Christopher J. Lindsell
Comparison of the therapeutic effects of 15 mg and 30 mg initial dosage of prednisolone daily in patients with subacute thyroiditis: protocol for a multicenter, randomized, open, parallel control study
Shaoyong Xu, Yuxin Jiang, Aihua Jia, Juan Zhang, Bin Gao, Jing Xu, Xiaorui Jing, Yang Jiao, Jia Wei, Wenlei Xu, Ruikun Chen, Ling Gao, Lei Shang
REDUCE (Reviewing long-term antidepressant use by careful monitoring in everyday practice) internet and telephone support to people coming off long-term antidepressants: protocol for a randomised controlled trial
Tony Kendrick, Adam W. A. Geraghty, Hannah Bowers, Beth Stuart, Geraldine Leydon, Carl May, Guiqing Yao, Wendy O’Brien, Marta Glowacka, Simone Holley, Samantha Williams, Shihua Zhu, Rachel Dewar-Haggart, Bryan Palmer, Margaret Bell, Sue Collinson, Imogen Fry, Glyn Lewis, Gareth Griffiths, Simon Gilbody, Joanna Moncrieff, Michael Moore, Una Macleod, Paul Little, Christopher Dowrick
Combined use of apatinib mesylate and vinorelbine versus vinorelbine alone in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial
Shuo Wu, Liang Zhang, Huan Li, Junnan Xu, Cui Jiang, Tao Sun
The effectiveness of an electronic pain management programme for the working population with chronic pain: study protocol for a randomized controlled trial
Shuk Kwan Tang, Mimi Mun Yee Tse, Sau Fong Leung, Theofanis Fotis
Evaluation of the efficacy and safety of intravenous remdesivir in adult patients with severe COVID-19: study protocol for a phase 3 randomized, double-blind, placebo-controlled, multicentre trial
Yeming Wang, Fei Zhou, Dingyu Zhang, Jianping Zhao, Ronghui Du, Yi Hu, Zhenshun Cheng, Ling Gao, Yang Jin, Guangwei Luo, Shouzhi Fu, Qiaofa Lu, Guanhua Du, Ke Wang, Yang Lu, Guohui Fan, Yi Zhang, Ying Liu, Shunan Ruan, Wen Liu, Thomas Jaki, Frederick G. Hayden, Peter W. Horby, Bin Cao, Chen Wang
Efficacy and safety of Bujing Yishi tablet for glaucoma with controlled IOP: study protocol for a multi-centre randomized controlled trial
Hongji Liu, Xiang Li, Zongduan Zhang, Jieping Zeng, Yan Dai, Chao Wang, Zhao Xie, Lin Cheng, Linru Cui
Radiotherapy-related skin toxicity (RAREST-02): A randomized trial testing the effect of a mobile application reminding head-and-neck cancer patients to perform skin care (reminder app) on radiation dermatitis
Dirk Rades, Carlos Andres Narvaez, Claudia Doemer, Stefan Janssen, Denise Olbrich, Soeren Tvilsted, Antonio J. Conde-Moreno, Jon Cacicedo
Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial
Julia Lühnen, Birte Berger-Höger, Burkhard Haastert, Jana Hinneburg, Jürgen Kasper, Anke Steckelberg
Comparison of blogshots with plain language summaries of Cochrane systematic reviews: a qualitative study and randomized trial
Ivan Buljan, Ružica Tokalić, Marija Roguljić, Irena Zakarija-Grković, Davorka Vrdoljak, Petra Milić, Livia Puljak, Ana Marušić
Analysis of responder-based endpoints: improving power through utilising continuous components
James Wason, Martina McMenamin, Susanna Dodd
Study Protocol for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a pragmatic, registry-based, multi-center, double-blind, randomized controlled trial evaluating the effect of intravenous fluid therapy with Plasma-Lyte 148 versus 0.9% saline on delayed graft function in deceased donor kidney transplantation
Michael G. Collins, Magid A. Fahim, Elaine M. Pascoe, Kathryn B. Dansie, Carmel M. Hawley, Philip A. Clayton, Kirsten Howard, David W. Johnson, Colin J. McArthur, Rachael C. McConnochie, Peter F. Mount, Donna Reidlinger, Laura Robison, Julie Varghese, Liza A. Vergara, Laurence Weinberg, Steven J. Chadban
Update to the AWED (Applying Wolbachia to Eliminate Dengue) trial study protocol: a cluster randomised controlled trial in Yogyakarta, Indonesia
Katherine L. Anders, Citra Indriani, Riris Andono Ahmad, Warsito Tantowijoyo, Eggi Arguni, Bekti Andari, Nicholas P. Jewell, Suzanne M. Dufault, Peter A. Ryan, Stephanie K. Tanamas, Edwige Rancès, Scott L. O’Neill, Cameron P. Simmons, Adi Utarini
The COVIRL-001 Trial: A multicentre, prospective, randomised trial comparing standard of care (SOC) alone, SOC plus hydroxychloroquine monotherapy or SOC plus a combination of hydroxychloroquine and azithromycin in the treatment of non- critical, SARS-CoV-2 PCR-positive population not requiring immediate resuscitation or ventilation but who have evidence of clinical decline: A structured summary of a study protocol for a randomised controlled trial
Eoin Feeney, Deborah Wallace, Aoife Cotter, Willard Tinago, Cormac McCarthy, David Keane, Rabia Hussain, Elena Alvarez Barco, Peter Doran, Patrick Mallon
Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial
Caroline Forde, Ronan McMullan, Mike Clarke, Richard H. Wilson, Ruth Plummer, Margaret Grayson, Cliona McDowell, Ashley Agus, Annmarie Doran, Danny F. McAuley, Anne L. Thomas, Rosemary A. Barnes, Richard Adams, Ian Chau, Vicky Coyle
A combined individual and group-based stabilization and skill training intervention versus treatment as usual for patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care – a study protocol for a randomized controlled trial
K. H. Holgersen, I. Brønstad, M. Jensen, H. Brattland, S. K. Reitan, A. M. Hassel, M. Arentz, M. Lara-Cabrera, A. E. Skjervold
Managing clustering effects and learning effects in the design and analysis of multicentre randomised trials: a survey to establish current practice
Elizabeth J. Conroy, Jane M. Blazeby, Girvan Burnside, Jonathan A. Cook, Carrol Gamble
Glioma patients in outpatient care—optimization of psychosocial care in neuro-oncological patients (GLIOPT): Protocol for a cluster randomized controlled trial
Mirjam Renovanz, Melina Hippler, Martin Voss, Jens Wehinger, Almuth F. Keßler, Jens Gempt, Minou Nadji-Ohl, Carolin Weiß Lucas, Marion Rapp, Martin Misch, Jan Coburger, Marcus Mehlitz, Jürgen Meixensberger, Naureen Keric, Ghazaleh Tabatabai, Maria Blettner, Melanie Schranz, Susanne Singer
Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial
Stephen B. Freedman, Sarah Williamson-Urquhart, Anna Heath, Petros Pechlivanoglou, Gareth Hopkin, Serge Gouin, Amy C. Plint, Andrew Dixon, Darcy Beer, Gary Joubert, Christopher McCabe, Yaron Finkelstein, Terry P. Klassen
A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial
C. M. Sackley, C. Rick, P. Au, M. C. Brady, G. Beaton, C. Burton, M. Caulfield, S. Dickson, F. Dowling, M. Hughes, N. Ives, S. Jowett, P. Masterson-Algar, A. Nicoll, S. Patel, C. H. Smith, R. Woolley, C. E. Clarke, A. Church, A. Davey, C. Gallagher, A. Conroy, S. Bailey, B. Done, D. Davies, S. Sveinbjornsdottir, M. Kasti, K. Allen, J. Colnet, J. Riches, L. Kittridge, L. Morris, C. Waszkiewicz, V. Lyell, V. Page, N. Bassford, H. Rayner, E. Henderson, S. Abraham, J. V. Hindle, S. Jones, P. Martin-Forbes, C. Watkins, A. Roberts, E. Newcombe, L. Bibby, L. Matthews, J. Roberts, S. Thomas, H. Hawthorne, K. Clewley, S. Lord, J. Roberts, G. Bretag, S. Noble, D. McGhee, H. Mcclure, A. Ling Zhi Teo, R. Wheeldon, C. Wilkinson, M. Oprea, G. Van Duyvenvoorde, N. Wilson, L. Evans, R. Belshaw, A. Clarke, M. Turner, C. Thompson, R. Saha, J. Aram, D. Mullan, J. Newman, K. Micabel, H. Robinson, K. Chick, J. Gaylard, J. Cochrane, E. C. Thomas, A. Kissick, P. Wright, B. Mohamed, S. Mahon, T. Williams, S. Appleton, N. Elliott, L. Evans, J. Ridley, A. Funaki, P. Daly, J. Hackworth, K. Timms, L. Evison, A. Bajracharya, M. Silverdale, K. Andrews, A. Davies, R. Bedford, A. Jones, D. Mournfield, L. Howieson, V. Price, J. Hunter, A. Baggs, L. Evans, R. Norton, M. Holland, K. Pointon, S. Kulkarni, S. Bobeldijk, S. Beames, J. Cavanagh, S. Sudlow, G. Lennox, R. Whittaker, D. Nelson, S. Pegler, C. Drayson, P. Turner, J. Stockwell, T. Andrews, E. White, E. Turner, T. Burnay, C. Hickey, S. Warner, R. Buccoliero, C. Isles, C. Stemp, J. Guy, C. Bennett, S. Smith, P. Randall, L. Ware, J. Cann, L. Sautin, S. Grobler, S. Adjei, A. Hankin, D. Ovayolu, M. Dobbs, O. Joyce, R. Humphreys, A. Jha, C. Holbrook, K. Rowsell, F. Johnson, H. Thornley, S. Conway, C. James, S. Murrow, M. Hughes, K. Pope, C. MacPhee, E. Williams, R. Hughes, A. Evans, A. Richmond, K. Pilborough, K. Campbell, S. E. Davies, A. Taylor, S. Thomas, D. Asandei, T. Majeed, J. Dawber, S. Furey, A. Oppetit, J. Birt, M. Hare, V. Fleming, A. Timoroksa, H. Al-Nufoury, S. Sharp, L. Freimann, I. Mavroudis, J. Alty, E. Richfield, J. Harrison, V. Smith, T. Joyce, J. Bamford, S. Jamieson, J. Cosgrove, S. Butterworth, E. Sacre, L. Makawa, P. Duggan-Carter, C. Arnold, K. Brown, P. Mpofu, C. Joyce, S. Henderson, C. Wiseman, L. Hyne, B. Stevens, A. Wood, D. Holland, V. Smith, J. Juada, S. Molloy, C. Pavel, M. Dhanarante, T. Adedoyin, C. Rowbottom, L. Little, R. Choudhury, L. Prados, A. Kelly, R. Eggers, T. Saifee, P. Poku, L. Niepage, D. Ahearn, A. Fountain, A. Curran, A. Watt, M. Wilson, A. Anderson, M. Graham, J. Taylor, P. Hewat, S. Donaldson, H. Moores-Poole, C. Angus, S. Coull, R. Davy, A. Gilmour-Graham, T. Mcilroy, A. Kendall, S. Pal, E. Messeder, D. Thomson, V. Johnston, P. Raby, S. Kinnear, P. F. Smith, S. Wishart, D. Grosset, J. Burns, A. L. Cunnington, E. Newman, C. Vennard, C. Dalton, T. Murphy, G. Ralph, A. Ritchie, C. Nelson, A. McEntee, P. Fowley, H. Hare, G. Beaton, M. Wilson, D. McDonald, J. Finlayson, A. Donaldson, S. Sutherland, S. Bramley, C. Dunn, M. Wallis, S. Hewitt, H. Morgan, A. Falconer, L. Peacock, A. McAlpine, C. McBrearty, A. Lowe, N. Findlay, A. Adam, C. Tearney, J. Picken, K. MacKenzie, L. McCallum, L. Smith, M. Sidney, P. Downie, L. Donnelly, R. McAllister, S. Campbell, S. Maclachlan, L. Shearer, K. Campbell, G. Duncan, S. Marrinan, M. Dewar, J. Kerr, L. Killin, A. Peters, A. Stewart, T. Daniels, A. Darbyshire, I. McCoy, U. Duff, F. Young, S. Orr, C. Telford, D. Fraser, S. Borthwick, H. Bailey, L. Karbownicki, E. McLeod, D. Sutherland, E. Sammler, L. Whyte, C. Young, L. Gillies, L. Gall, J. Dallas, L. Cassidy, E. Letham, V. Salisbury, L. Anderson, C. Hutton, S. Waggett, D. Anderson, A. Mcgee, S. Cooper, G. Mamutse, A. Niruban, A. Bath, A. Wiltshire, M. Harmer, C. Wright, J. Graham, K. Richardson, J. Tyler, L. Isaacs, N. Crow, S. Pinnell, W. Neale, L. Maloney, R. Weller, K. Young, C. Squire, A. Whone, Y. Hernandez, H. Findlay, K. King, L. Gethin, S. Ticehurst, A. Swift, J. Short, J. Dean, C. Westcott, K. Thomas, S. Cottrell, D. Kruszynska, S. Kamath, Q. Ma, J. Hall, R. Wilson, H. Goodhand, K. Mellows, L. J. Cottam, T. Behan, J. Gibson, E. Lomas, J. Kirk, L. Smith, J. Benson, J. Raw, P. Mulligan, A. Ansari, R. Irving, A. Javed, S. Hussain, L. Johnson, R. Joseph, J. Brooke, J. Melville, M. McCormack, J. Stockley, D. Ganderton, A. Cherriman, J. Price, C. Douglas, C. Cooter, J. Bushell, R. Sheridan, C. Browning, K. Polverino, T. Malone, S. Jackson, A. Foden, R. James, S. Hayes, L. Roberts, E. Davis, C. Clarke, D. Nicholl, A. Majeed, M. T. Oo, K. Blachford, A. Boughey, J. Kaur, S. Kaur, M. Awan, S. Rahman, J. Round, D. Gandecha, S. Williams, S. Dealing, H. Moss, L. Talbot, S. Cooper, R. Sophia, J. Allen, S. Cox, C. Moreira, D. Woolven, D. Sharratt, E. Foster, H. Hurren, J. Watson, S. Northover, D. Green, A. Treloggen, C. Pawley, K. Beesley, K. Milne, L. Howard, S. Craw, A. Lewis, A. Whitcher, C. Vickers, T. Russell, A. Sykes, H. Meikle, N. Loraine, M. Steiger, H. Treloar, L. Roebuck, M. Taylor, R. Nashed, J. Garfield-Smith, S. Mills, H. Griffin, C. Marshall, G. De Selincourt, V. Queen, M. Stone, M. Farrow-Jones, E. Sturdy, K. Almedilla, F. Fitzsimmons, M. Alison, F. Rogers, B. Reed, M. Pinkney, S. Jones, S. Muzerengi, M. Johnson, S. Stafford, E. Parmar, J. Albutt, S. Kaur, M. Awan, S. Rahman, K. Leahy, T. Allain, M. Sritharan, A. Daniell, K. Kunsteinaite, S. Slade, F. Pimbblet, C. Killourhey, E. Wales, C. Hughes, G. Horsfield, L. Mercer, Z. Roberts, K. Stock, M. Evans, S. Boyd, L. King, J. Birch, S. Anderson, C. Evans, N. Stapleton, U. Magennis, R. Vernall
Core outcome set measurement for future clinical trials in acute myeloid leukemia: the HARMONY study protocol using a multi-stakeholder consensus-based Delphi process and a final consensus meeting
Katharina M. Lang, Kathryn L. Harrison, Paula R. Williamson, Brian J. P. Huntly, Gert Ossenkoppele, Jan Geissler, Tamàs Bereczky, Jesús M. Hernández-Rivas, Hélène Chevrou-Séverac, Rory Goodbody, Renate Schulze-Rath, Lars Bullinger
Correction to: Effects of robot-assisted gait training in patients with Parkinson’s disease: study protocol for a randomized controlled trial
Min-Gu Kang, Seo Jung Yun, Hyun Iee Shin, Eunkyung Kim, Hyun Haeng Lee, Byung-Mo Oh, Han Gil Seo
Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study
Christine M. Bond, Richard Holland, David P. Alldred, Antony Arthur, Garry Barton, Linda Birt, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel M. Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris, Fiona M. Poland, Lee Shepstone, Arnold Zermansky, David Wright, Laura Watts, Joanna Williams, Bronwen Harry, Jeanette Blacklock, Caroline Hill, Frances Johnston, Jacqueline Inch, Frances Notman, Lindsay Dalgarno, Amrit Daffu O’Reilly, Mairead McGrattan
Cognitive behavioural therapy for insomnia in patients with rheumatoid arthritis: protocol for the randomised, single-blinded, parallel-group Sleep-RA trial
K. M. Latocha, K. B. Løppenthin, M. Østergaard, P. J. Jennum, R. Christensen, M. Hetland, H. Røgind, T. Lundbak, J. Midtgaard, B. A. Esbensen
Patient-reported outcome measures for monitoring primary care patients with depression (PROMDEP): study protocol for a randomised controlled trial
Tony Kendrick, Michael Moore, Geraldine Leydon, Beth Stuart, Adam W. A. Geraghty, Guiqing Yao, Glyn Lewis, Gareth Griffiths, Carl May, Rachel Dewar-Haggart, Samantha Williams, Shihua Zhu, Christopher Dowrick
NUrse-led COntinuum of care for people with Diabetes and prediabetes (NUCOD) in Nepal: study protocol for a cluster randomized controlled trial
Dong ( Roman) Xu, Rubee Dev, Abha Shrestha, Lingling Zhang, Archana Shrestha, Pushpanjali Shakya, James P. Hughes, Prabin Raj Shakya, Jinghua Li, Jing Liao, Biraj Man Karmacharya
Evaluation of an intervention to support decisions on disclosure in the employment setting (DECIDES): study protocol of a longitudinal cluster-randomized controlled trial
K. M. E. Janssens, J. van Weeghel, C. Henderson, M. C. W. Joosen, E. P. M. Brouwers
High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography in high risk cases (OTHER): study protocol of a randomised multicentric trial
Venkatesan Thiruvenkatarajan, Ashok Dharmalingam, Gilberto Arenas, Medhat Wahba, Reinhard Steiner, Vasanth Rao Kadam, Andre Tran, John Currie, Roelof Van Wijk, Anthony Quail, Guy Ludbrook
An under-represented and underserved population in trials: methodological, structural, and systemic barriers to the inclusion of adults lacking capacity to consent
Victoria Shepherd
Resistance training combined with blood flow restriction in cirrhosis: study protocol for a randomized controlled trial
Sanmy Rocha Nóbrega, Silvana Gama Florencio Chachá, Cleiton Augusto Libardi
Safety and efficacy of direct Cardiac Shockwave Therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial
Leo Pölzl, Felix Nägele, Michael Graber, Jakob Hirsch, Daniela Lobenwein, Martina Mitrovic, Agnes Mayr, Markus Theurl, Michael Schreinlechner, Matthias Pamminger, Christian Dorfmüller, Michael Grimm, Can Gollmann-Tepeköylü, Johannes Holfeld
Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study)
Caroline Gronnier, Cécile Chambrier, Alain Duhamel, Benoît Dervaux, Denis Collet, Delphine Vaudoyer, Jean-Marc Régimbeau, Jacques Jougon, Jérémie Théréaux, Gil Lebreton, Julie Veziant, Alain Valverde, Pablo Ortega-Deballon, François Pattou, Muriel Mathonnet, Julie Perinel, Laura Beyer-Berjot, David Fuks, Philippe Rouanet, Jérémie H. Lefevre, Pierre Cattan, Sophie Deguelte, Bernard Meunier, Jean-Jacques Tuech, Patrick Pessaux, Nicolas Carrere, Ephrem Salame, Eleonor Benaim, Bertrand Dousset, Simon Msika, Christophe Mariette, Guillaume Piessen
The value of post-operative antibiotic therapy after laparoscopic appendectomy for complicated acute appendicitis: a prospective, randomized, double-blinded, placebo-controlled phase III study (ABAP study)
C. Sabbagh, N. Siembida, H. Dupont, M. Diouf, J. L. Schmit, S. Boddaert, J. M. Regimbeau
Genetic basis for prediction of non-responders to dietary plant sterol intervention (GenePredict-PS): a study protocol for a double-blind, placebo-controlled, randomized two-period crossover study
Maryam Shamloo, Matthew J. Granger, Elke A. Trautwein, James D. House, Dylan MacKay
The Stop-Tabac smartphone application for smoking cessation: study protocol for a randomized controlled trial in the general population
Jean-François Etter, Yasser Khazaal
Study of Medical Ultrasound for Rhizarthrosis (SUR): study protocol for a randomized controlled single-center pilot-trial
Markus Bock, Andreas Eisenschenk, Heiko Lorenzen, Martin Lautenbach
Comparing the effectiveness of magnesium oxide and naldemedine in preventing opioid-induced constipation: a proof of concept, single institutional, two arm, open-label, phase II, randomized controlled trial: the MAGNET study
Anna Ozaki, Takaomi Kessoku, Michihiro Iwaki, Takashi Kobayashi, Tsutomu Yoshihara, Takayuki Kato, Yasushi Honda, Yuji Ogawa, Kento Imajo, Takuma Higurashi, Masato Yoneda, Masataka Taguri, Takeharu Yamanaka, Hiroto Ishiki, Noritoshi Kobayashi, Satoru Saito, Yasushi Ichikawa, Atsushi Nakajima
Problem solving therapy (PST) tailored for intimate partner violence (IPV) versus standard PST and enhanced usual care for pregnant women experiencing IPV in rural Ethiopia: protocol for a randomised controlled feasibility trial
Roxanne C. Keynejad, Tesera Bitew, Katherine Sorsdahl, Bronwyn Myers, Simone Honikman, Girmay Medhin, Negussie Deyessa, Nick Sevdalis, Wietse A. Tol, Louise Howard, Charlotte Hanlon
Impact of fecal microbiota transplantation on chronic recurrent pouchitis in ulcerative colitis with ileo-anal anastomosis: study protocol for a prospective, multicenter, double-blind, randomized, controlled trial
Caroline Trang-Poisson, Elise Kerdreux, Alexandra Poinas, Lucie Planche, Harry Sokol, Pascale Bemer, Karine Cabanas, Eliane Hivernaud, Laetitia Biron, Laurent Flet, Emmanuel Montassier, Ghislaine Le Garcasson, Anne Chiffoleau, Alexandra Jobert, Didier Lepelletier, Jocelyne Caillon, Patrice Le Pape, Berthe-Marie Imbert, Arnaud Bourreille
Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial
William J. Meurer, Mackenzie Dinh, Kelley M. Kidwell, Adam Flood, Emily Champoux, Candace Whitfield, Deborah Trimble, Joan Cowdery, Dominic Borgialli, Sacha Montas, Rebecca Cunningham, Lorraine R. Buis, Devin Brown, Lesli Skolarus
Changes to aspects of ongoing randomised controlled trials with fixed designs
Xanthi Coskinas, John Simes, Manjula Schou, Andrew James Martin
MOdified DIagnostic strateGy to safely ruLe-out pulmonary embolism In the emergency depArtment: study protocol for the Non-Inferiority MODIGLIANI cluster cross-over randomized trial
Anne-Laure Philippon, Margaux Dumont, Sonia Jimenez, Sarah Salhi, Marine Cachanado, Isabelle Durand-Zaleski, Tabassome Simon, Yonathan Freund
Evaluating the efficacy and safety of GKT137831 in adults with type 1 diabetes and persistently elevated urinary albumin excretion: a statistical analysis plan
Alysha M. De Livera, Anne Reutens, Mark Cooper, Merlin Thomas, Karin Jandeleit-Dahm, Jonathan E. Shaw, Agus Salim
CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins
Sungsin Cho, Hyung Sub Park, Taeseung Lee, Seung Jae Byun, Woo-Sung Yun, Shin-Seok Yang, Hyangkyoung Kim, Woo-Shik Kim, Jin Hyun Joh, In Mok Jung
Effect of transcranial direct current stimulation on sports performance for two profiles of athletes (power and endurance) (COMPETE): a protocol for a randomised, crossover, double blind, controlled exploratory trial
Yohan Grandperrin, Sidney Grosprêtre, Magali Nicolier, Philippe Gimenez, Chrystelle Vidal, Emmanuel Haffen, Djamila Bennabi
Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trial
Ellen Gorman, Manu Shankar-Hari, Phil Hopkins, William S. Tunnicliffe, Gavin D. Perkins, Jonathan Silversides, Peter McGuigan, Colette Jackson, Roisin Boyle, Jamie McFerran, Cliona McDowell, Christina Campbell, Margaret McFarland, Jon Smythe, Jacqui Thompson, Barry Williams, Gerard Curley, John G. Laffey, Mike Clarke, Cecilia O’Kane, Daniel F. McAuley
A multi-centre, pragmatic, three-arm, individually randomised, non-inferiority, open trial to compare immediate orally administered, immediate topically administered or delayed orally administered antibiotics for acute otitis media with discharge in children: The Runny Ear Study (REST): study protocol
Kathryn Curtis, Michael Moore, Christie Cabral, Vasa Curcin, Jeremey Horwood, Richard Morris, Vibhore Prasad, Anne Schilder, Nicholas Turner, Scott Wilkes, Alastair D. Hay, Jodi Taylor
The efficacy of the novel zinc-containing desensitizer CAREDYNE Shield on dentin hypersensitivity: a study protocol for a pilot randomized controlled trial
Takashi Matsuura, Megumi Mae, Masayuki Ohira, Yasunori Yamashita, Ayako Nakazono, Kouji Sugimoto, Kajiro Yanagiguchi, Shizuka Yamada
Overall adjustment acupuncture for postmenopausal osteoporosis (PMOP): a study protocol for a randomized sham-controlled trial
Z. Q. Ren, Y. F. Wang, G. F. Ao, H. X. Chen, M. Huang, M. X. Lai, H. D. Zhao, R. Zhao
A randomized multicenter clinical trial to evaluate the efficacy of melatonin in the prophylaxis of SARS-CoV-2 infection in high-risk contacts (MeCOVID Trial): A structured summary of a study protocol for a randomised controlled trial
Irene García García, Miguel Rodriguez-Rubio, Amelia Rodríguez Mariblanca, Lucía Martínez de Soto, Lucía Díaz García, Jaime Monserrat Villatoro, Javier Queiruga Parada, Enrique Seco Meseguer, María J. Rosales, Juan González, José R. Arribas, Antonio J. Carcas, Pedro de la Oliva, Alberto M. Borobia
Effect of hydroxychloroquine on prevention of COVID-19 virus infection among healthcare professionals: a structured summary of a study protocol for a randomised controlled trial
Reihaneh Pirjani, Tahereh Soori, Ahmad Reza Dehpour, Mahdi Sepidarkish, Ashraf Moini, Arshia Shizarpour, Razieh Mohammad Jafari
Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial
Bastiaan Maes, Cedric Bosteels, Elisabeth De Leeuw, Jozefien Declercq, Karel Van Damme, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart Lambrecht
A short, animated video to improve good COVID-19 hygiene practices: a structured summary of a study protocol for a randomized controlled trial
Alain Vandormael, Maya Adam, Merlin Greuel, Till Bärnighausen
A prospective, randomised, double blind placebo-controlled trial to evaluate the efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia (TOC-COVID): A structured summary of a study protocol for a randomised controlled trial
Jonathan Rilinger, Winfried V. Kern, Daniel Duerschmied, Alexander Supady, Christoph Bode, Dawid L. Staudacher, Tobias Wengenmayer
Correction to: Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial
B. Joseph Elmunzer, Jose Serrano, Amitabh Chak, Steven A. Edmundowicz, Georgios I. Papachristou, James M. Scheiman, Vikesh K. Singh, Shyam Varadarajulu, John J. Vargo, Field F. Willingham, Todd H. Baron, Gregory A. Coté, Joseph Romagnuolo, April Wood-Williams, Emily K. Depue, Rebecca L. Spitzer, Cathie Spino, Lydia D. Foster, Valerie Durkalski
Controlled, double-blind, randomized trial to assess the efficacy and safety of hydroxychloroquine chemoprophylaxis in SARS CoV2 infection in healthcare personnel in the hospital setting: A structured summary of a study protocol for a randomised controlled trial
Antonio Cuadrado-Lavín, José Manuel Olmos, José Manuel Cifrian, Teresa Gimenez, Marco Antonio Gandarillas, Mar García-Saiz, Maria Henar Rebollo, Victor Martínez-Taboada, Marcos López-Hoyos, María Carmen Fariñas, Javier Crespo
Effectiveness of Interferon Beta 1a, compared to Interferon Beta 1b and the usual therapeutic regimen to treat adults with moderate to severe COVID-19: structured summary of a study protocol for a randomized controlled trial
Seyed Sina Naghibi Irvani, Maryam Golmohammadi, Mohamad Amin Pourhoseingholi, Shervin Shokouhi, Ilad Alavi Darazam
Umbilical cord blood therapy to prevent progression of COVID-19 related pneumonia: a structured summary of a study protocol for a pilot randomised controlled trial
Atul Malhotra, David Ernest, Benjamin A. Rogers, David Haylock, Ashalyn Watt, Guy Moeneclaey, Graham Jenkin
Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial
Ruanne V. Barnabas, Elizabeth Brown, Anna Bershteyn, R. Scott Miller, Mark Wener, Connie Celum, Anna Wald, Helen Chu, David Wesche, Jared M. Baeten
Digital tools for trial recruitment and retention—plenty of tools but rigorous evaluation is in short supply
Shaun Treweek, Matthias Briel
Cluster randomised trials of prescribing policy: an ethical approach to generating drug safety evidence? A discussion of the ethical application of a new research method
Amy Rogers, Gillian Craig, Angela Flynn, Isla Mackenzie, Thomas MacDonald, Alexander Doney
Digital tools for the recruitment and retention of participants in randomised controlled trials: a systematic map
Geoff K. Frampton, Jonathan Shepherd, Karen Pickett, Gareth Griffiths, Jeremy C. Wyatt
The clinical and cost effectiveness of surgical interventions for stones in the lower pole of the kidney: the percutaneous nephrolithotomy, flexible ureterorenoscopy and extracorporeal shockwave lithotripsy for lower pole kidney stones randomised controlled trial (PUrE RCT) protocol
Sam McClinton, Kathryn Starr, Ruth Thomas, Graeme MacLennan, Thomas Lam, Rodolfo Hernandez, Robert Pickard, Ken Anson, Terry Clark, Steven MacLennan, David Thomas, Daron Smith, Ben Turney, Alison McDonald, Sarah Cameron, Oliver Wiseman
Pragmatic cluster randomized trial to evaluate effectiveness and implementation of enhanced EHR-facilitated cancer symptom control (E2C2)
Lila J. Finney Rutten, Kathryn J. Ruddy, Linda L. Chlan, Joan M. Griffin, Jeph Herrin, Aaron L. Leppin, Deirdre R. Pachman, Jennifer L. Ridgeway, Parvez A. Rahman, Curtis B. Storlie, Patrick M. Wilson, Andrea L. Cheville
Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials
Thijs ten Doesschate, Simone J. C. F. M. Moorlag, Thomas W. van der Vaart, Esther Taks, Priya Debisarun, Jaap ten Oever, Chantal P. Bleeker-Rovers, Patricia Bruijning Verhagen, Arief Lalmohamed, Rob ter Heine, Reinout van Crevel, Janneke van de Wijgert, Axel B. Janssen, Marc J. Bonten, Cornelis H. van Werkhoven, Mihai G. Netea
Efficacy and safety of YinQiSanHuang-antiviral decoction in chronic hepatitis B: study protocol for a randomized, placebo-controlled, double-blinded trial
Qing-Juan Wu, Wen-Liang Lv, Juan-Mei Li, Ting-Ting Zhang, Wen-hui Zhou, Qiang Zhang, Jiu-Chong Wang, Qing-Nan Wang, Ruo-Xuan Zhang, Xin Zhao, Si-Tong Chen, Shuang Liu, Gao-Hui Li, Zheng-Min Cao, Lei Xu, Jing Chen
The effects of Anethum graveolens (dill) powder supplementation on clinical and metabolic status in patients with type 2 diabetes
Fatemeh Haidari, Mehrnoosh Zakerkish, Fatemeh Borazjani, Kambiz Ahmadi Angali, Golnaz Amoochi Foroushani
Optimisation of the ActWELL lifestyle intervention programme for women attending routine NHS breast screening clinics
Annie S. Anderson, Angela M. Craigie, Stephanie Gallant, Chloe McAdam, E. Jane Macaskill, Jennifer McKell, Nanette Mutrie, Ronan E. O’Carroll, Naveed Sattar, Martine Stead, Shaun Treweek
Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial
Magnus Nakrem Lyngbakken, Jan-Erik Berdal, Arne Eskesen, Dag Kvale, Inge Christoffer Olsen, Anbjørg Rangberg, Christine Monceyron Jonassen, Torbjørn Omland, Helge Røsjø, Olav Dalgard
Evidencing the impact of cancer trials: insights from the 2014 UK Research Excellence Framework
Catherine R. Hanna, Lauren P. Gatting, Kathleen Anne Boyd, Kathryn A. Robb, Rob J. Jones
Does a ketogenic diet as an adjuvant therapy for drug treatment enhance chemotherapy sensitivity and reduce target lesions in patients with locally recurrent or metastatic Her-2-negative breast cancer? Study protocol for a randomized controlled trial
Yan Wang, Ming-Xi Jing, Lei Jiang, Yu-Feng Jia, E. Ying, Hui Cao, Xiang-Yu Guo, Tao Sun
The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial
Jiawen Li, Chi Zhang, Zhao Wu, Guiqiang Wang, Hong Zhao
Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial
Nooshin Dalili, Alireza Kashefizadeh, Mohsen Nafar, Fatemeh Poorrezagholi, Ahmad Firouzan, Fariba Samadian, Shiva Samavat, Shadi Ziaie, Somayeh Fatemizadeh
Efficacy of Parent-Infant-Psychotherapy with mothers with postpartum mental disorder: study protocol of the randomized controlled trial as part of the SKKIPPI project
J. Mattheß, M. Eckert, K. Richter, G. Koch, T. Reinhold, P. Vienhues, A. Berghöfer, S. Roll, T. Keil, F. Schlensog-Schuster, K. von Klitzing, C. Ludwig-Körner, L. Kuchinke
Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial
Cedric Bosteels, Bastiaan Maes, Karel Van Damme, Elisabeth De Leeuw, Jozefien Declercq, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart Lambrecht
Prednisolone versus placebo addition in the treatment of patients with recent-onset psychotic disorder: a trial design
Lyliana G. Nasib, Iris E. Sommer, Inge Winter - van Rossum, Jacqueline de Vries, Shiral S. Gangadin, Priscilla P. Oomen, Gurmeet Judge, Renske E. Blom, Jurjen J. Luykx, Nico J. M. van Beveren, Natalie D. Veen, Rune A. Kroken, Erik L. Johnsen
Study protocol for prognosis and treatment strategy of peripheral persistent avascular retina after intravitreal anti-VEGF therapy in retinopathy of prematurity
Ying Yu, Jianxun Wang, Feng Chen, Wensi Chen, Nan Jiang, Daoman Xiang
Quality, scope and reporting standards of randomised controlled trials in Irish Health Research: an observational study
Barbara Clyne, Fiona Boland, Norah Murphy, Edel Murphy, Frank Moriarty, Alan Barry, Emma Wallace, Tatyana Devine, Susan M. Smith, Declan Devane, Andrew Murphy, Tom Fahey
Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial
Chi Zhang, Jiawen Li, Zhao Wu, He Wang, Chengli Que, Hong Zhao, Guiqiang Wang
Beta-adrenergic antagonist for the healing of chronic diabetic foot ulcers: study protocol for a prospective, randomized, double-blinded, controlled and parallel-group study
Ramanjot Kaur, Catherine Tchanque-Fossuo, Kaitlyn West, Yasmin Hadian, Anthony Gallegos, Daniel Yoon, Ligia Ismailyan, Saul Schaefer, Sara E. Dahle, R. Rivkah Isseroff
Elbow hemiarthroplasty versus open reduction and internal fixation for AO/OTA type 13 C2 and C3 fractures of distal humerus in patients aged 50 years or above: a randomized controlled trial
Ali Al-Hamdani, Jeppe V. Rasmussen, Kenneth Holtz, Bo S. Olsen
The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial
Carlos Chaccour, Paula Ruiz-Castillo, Mary-Ann Richardson, Gemma Moncunill, Aina Casellas, Francisco Carmona-Torre, Miriam Giráldez, Juana Schwartz Mota, José Ramón Yuste, José Ramón Azanza, Miriam Fernández, Gabriel Reina, Carlota Dobaño, Joe Brew, Belen Sadaba, Felix Hammann, Regina Rabinovich
Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial
Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz, Steven L. Spitalnik, Andrew Eisenberger, Eldad A. Hod, Jessica Justman, Ken Cheung, W. Ian Lipkin, Max R. O’Donnell
Does internal limiting membrane peeling during epiretinal membrane surgery induce microscotomas on microperimetry? Study protocol for PEELING, a randomized controlled clinical trial
Jean-Baptiste Ducloyer, Juliette Ivan, Alexandra Poinas, Olivier Lebreton, Alexandre Bonissent, Paul Fossum, Christelle Volteau, Ramin Tadayoni, Catherine Creuzot-Garchet, Yannick Le Mer, Julien Perol, June Fortin, Anne Chiffoleau, Fanny Billaud, Catherine Ivan, Michel Weber
Implementation and evaluation of a nurse-led decision-coaching program for healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers: a study protocol for the randomized controlled EDCP-BRCA study
A. Isselhard, M. Töpper, B. Berger-Höger, A. Steckelberg, H. Fischer, F. Vitinius, K. Beifus, J. Köberlein-Neu, R. Wiedemann, K. Rhiem, R. Schmutzler, S. Stock
A group- and smartphone-based psychological intervention to increase and maintain physical activity in patients with musculoskeletal conditions: study protocol for a randomized controlled trial (“MoVo-App”)
Jiaxi Lin, Ramona Wurst, Sarah Paganini, Vivien Hohberg, Stephan Kinkel, Wiebke Göhner, Christina Ramsenthaler, Reinhard Fuchs
Correction to: Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD)
Toshinari Yamashita, Norikazu Masuda, Shigehira Saji, Kazuhiro Araki, Yoshinori Ito, Toshimi Takano, Masato Takahashi, Junji Tsurutani, Kei Koizumi, Masahiro Kitada, Yasuyuki Kojima, Yasuaki Sagara, Hiroshi Tada, Tsutomu Iwasa, Takayuki Kadoya, Tsuguo Iwatani, Hiroki Hasegawa, Satoshi Morita, Shinji Ohno
Treatment with Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide in COVID-19 patients with risk factors for poor prognosis: A structured summary of a study protocol for a randomised controlled trial
José Meneses Calderón, Hugo Mendieta Zerón, Srivatsan Padmanabhan
Antioxidant dressing therapy versus standard wound care in chronic wounds (the REOX study): study protocol for a randomized controlled trial
Inés María Comino-Sanz, María Dolores López-Franco, Begoña Castro, Pedro Luis Pancorbo-Hidalgo
A pilot study of therapeutic plasma exchange for serious SARS CoV-2 disease (COVID-19): A structured summary of a randomized controlled trial study protocol
Fahad Faqihi, Abdulrahman Alharthy, Mohammed Alodat, Daood Asad, Waleed Aletreby, Demetrios J. Kutsogiannis, Peter G. Brindley, Dimitrios Karakitsos
Methods for assessment of patient adherence to removable orthoses used after surgery or trauma to the appendicular skeleton: a systematic review
Gareth Davies, Daniel Yeomans, Zoe Tolkien, Irene A. Kreis, Shelley Potter, Matthew D. Gardiner, Abhilash Jain, James Henderson, Jane M. Blazeby
Implementing self-management: a mixed methods study of women’s experiences of a postpartum hypertension intervention (SNAP-HT)
Alexandra E. Cairns, Katherine L. Tucker, Carole Crawford, Richard J. McManus, John Powell
Evaluating a multicomponent program to improve hypertension control in Guatemala: study protocol for an effectiveness-implementation cluster randomized trial
Alejandra Paniagua-Avila, Meredith P. Fort, Russell E. Glasgow, Pablo Gulayin, Diego Hernández-Galdamez, Kristyne Mansilla, Eduardo Palacios, Ana Lucia Peralta, Dina Roche, Adolfo Rubinstein, Jiang He, Manuel Ramirez-Zea, Vilma Irazola
LIVE@Home.Path—innovating the clinical pathway for home-dwelling people with dementia and their caregivers: study protocol for a mixed-method, stepped-wedge, randomized controlled trial
Bettina Sandgathe Husebo, Heather Allore, Wilco Achterberg, Renira Corinne Angeles, Clive Ballard, Frøydis Kristine Bruvik, Stein Erik Fæø, Marie Hidle Gedde, Eirin Hillestad, Frode Fadnes Jacobsen, Øyvind Kirkevold, Egil Kjerstad, Reidun Lisbeth Skeide Kjome, Janne Mannseth, Mala Naik, Rui Nouchi, Nathalie Puaschitz, Rune Samdal, Oscar Tranvåg, Charalampos Tzoulis, Ipsit Vihang Vahia, Maarja Vislapuu, Line Iden Berge
Modulation of gut microbiota through nutritional interventions in Behçet’s syndrome patients (the MAMBA study): study protocol for a randomized controlled trial
Giuditta Pagliai, Monica Dinu, Claudia Fiorillo, Matteo Becatti, Silvia Turroni, Giacomo Emmi, Francesco Sofi
Traditional Chinese medicine Lingguizhugan decoction treating non-alcoholic fatty liver disease with spleen-yang deficiency pattern: Study protocol for a multicenter randomized controlled trial
Jingjuan Xu, Ruirui Wang, Shengfu You, Lei Zhang, Peiyong Zheng, Guang Ji, Baocheng Liu
Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial
Pradeesh Sivapalan, Charlotte Suppli Ulrik, Rasmus Dahlin Bojesen, Therese Sophie Lapperre, Josefin Viktoria Eklöf, Kjell Erik Julius Håkansson, Andrea Browatzki, Casper Tidemansen, Jon Torgny Wilcke, Julie Janner, Vibeke Gottlieb, Howraman Meteran, Celeste Porsbjerg, Birgitte Lindegaard Madsen, Mia Moberg, Lars Pedersen, Thomas Lars Benfield, Jens Dilling Lundgren, Filip Krag Knop, Tor Biering-Sørensen, Muzhda Ghanizada, Tine Peick Sonne, Uffe Christian Steinholtz Bødtger, Sidse Graff Jensen, Daniel Bech Rasmussen, Eva Brøndum, Oliver Djurhuus Tupper, Susanne Wiemann Sørensen, Gitte Alstrup, Christian Borbjerg Laursen, Ulla Weinrich Møller, Asger Sverrild, Jens-Ulrik Stæhr Jensen
Do investigator meetings improve recruitment rates in clinical trials? A retrospective before-and-after study of data from nine multi-centre clinical trials
E. J. Mitchell, P. J. Godolphin, G. Meakin, K. Sprange
Achieving blood pressure control targets in hypertensive patients of rural China – a pilot randomized trial
Xiao Huang, Lishun Liu, Yun Song, Lan Gao, Min Zhao, Huihui Bao, Xianhui Qin, Yanqing Wu, Qinghua Wu, Chonglei Bi, Aiping Yue, Chongqian Fang, Hai Ma, Yimin Cui, Genfu Tang, Ping Li, Yan Zhang, Jianping Li, Binyan Wang, Xiping Xu, Hong Wang, Gianfranco Parati, J. David Spence, Xiaobin Wang, Yong Huo, Guangliang Chen, Xiaoshu Cheng
Less invasive surfactant administration versus endotracheal surfactant instillation followed by limited peak pressure ventilation in preterm infants with respiratory distress syndrome in China: study protocol for a randomized controlled trial
Jiajun Zhu, Yingying Bao, Lizhong Du, Huafei Huang, Qin lv, Yejun Jiang, Yuxuan Dai, Zhijun Chen, Jingyun Shi, Yongyan Shi, Chuangzhong Yang, Hua Mei, Hong Jiang, Yanhui Sun, Xuemei Sun
Enhanced care planning and clinical-community linkages versus usual care to address basic needs of patients with multiple chronic conditions: a clinician-level randomized controlled trial
Alex H. Krist, Kristen O’Loughlin, Steven H. Woolf, Roy T. Sabo, Jennifer Hinesley, Anton J. Kuzel, Bruce D. Rybarczyk, Paulette Lail Kashiri, E. Marshall Brooks, Russel E. Glasgow, Amy G. Huebschmann, Winston R. Liaw
A feasibility study of a WhatsApp-delivered Transtheoretical Model-based intervention to promote healthy eating habits for firefighters in Hong Kong: a cluster randomized controlled trial
Wing Man Ng, Kin Cheung
Effectiveness of inspiratory muscle training associated with a cardiac rehabilitation program on sympathetic activity and functional capacity in patients with heart failure: a study protocol for a randomized controlled trial
Jéssica Costa Leite, Daniella Cunha Brandão, Simone Cristina Soares Brandão, Helen Kerlen Bastos Fuzari, Tainá Maria Vidal, Jasiel Frutuoso, Maria Inês Remígio, Bruna Thays Santana de Araújo, Shirley Lima Campos, Armele Dornelas de Andrade
Safety and efficacy assessment of allogeneic human dental pulp stem cells to treat patients with severe COVID-19: structured summary of a study protocol for a randomized controlled trial (Phase I / II)
Qingsong Ye, Hua Wang, Xia Xia, Chenliang Zhou, Zhiming Liu, Zun-en Xia, Zhan Zhang, Yang Zhao, Jun Yehenala, Si Wang, Gangqiao Zhou, Ke Hu, Bin Wu, Chu-Tse Wu, Songling Wang, Yan He
Ropivacaine 75 mg versus placebo in perineal infiltration for analgesic efficacy at mid- and long-term for episiotomy repair in postpartum women – the ROPISIO study: a two-center, randomized, double-blind, placebo-controlled trials
Claire Cardaillac, Stéphane Ploteau, Aurélie Le Thuaut, Vincent Dochez, Norbert Winer, Guillaume Ducarme
Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial
Maisa S. Ziadni, Abby L. Chen, Tyler Winslow, Sean C. Mackey, Beth D. Darnall
Corneal cross-linking versus standard care in children with keratoconus – a randomised, multicentre, observer-masked trial of efficacy and safety (KERALINK): a statistical analysis plan
Kashfia Chowdhury, Caroline J. Doré, Catey Bunce, Daniel F. P. Larkin
Opportunistic treatment of hepatitis C virus infection (OPPORTUNI-C): study protocol for a pragmatic stepped wedge cluster randomized trial of immediate versus outpatient treatment initiation among hospitalized people who inject drugs
H. Midgard, A. K. Finbråten, K. B. Malme, R. M. Berg-Pedersen, L. Tanum, I. C. Olsen, R. Bjørnestad, O. Dalgard
Efficacy, safety, and economic assessment of hominis placental pharmacopuncture for chronic temporomandibular disorder: a protocol for a multicentre randomised controlled trial
Jongho Kim, Kyoung Sun Park, Yoon Jae Lee, Koh-Woon Kim, Jae-Heung Cho, In-Hyuk Ha
Correction to: Effectiveness of a multi-level intervention to reduce men’s perpetration of intimate partner violence: a cluster randomised controlled trial
Nicola J. Christofides, Abigail M. Hatcher, Dumisani Rebombo, Ruari-Santiago McBride, Shehnaz Munshi, Angelica Pino, Nada Abdelatif, Dean Peacock, Jonathan Levin, Rachel K. Jewkes
Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial
Ariane Mamguem Kamga, Cyril Di Martino, Amelie Anota, Sophie Paget-Bailly, Charles Coutant, Patrick Arveux, Isabelle Desmoulins, Tienhan Sandrine Dabakuyo-Yonli
The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design
Munyaradzi Dimairo, Philip Pallmann, James Wason, Susan Todd, Thomas Jaki, Steven A. Julious, Adrian P. Mander, Christopher J. Weir, Franz Koenig, Marc K. Walton, Jon P. Nicholl, Elizabeth Coates, Katie Biggs, Toshimitsu Hamasaki, Michael A. Proschan, John A. Scott, Yuki Ando, Daniel Hind, Douglas G. Altman, Munyaradzi Dimairo, Toshimitsu Hamasaki, Susan Todd, Christopher J. Weir, Adrian P. Mander, James Wason, Franz Koenig, Steven A. Julious, Daniel Hind, Jon Nicholl, Douglas G. Altman, William J. Meurer, Christopher Cates, Matthew Sydes, Yannis Jemiai, Deborah Ashby, Christina Yap, Frank Waldron-Lynch, James Roger, Joan Marsh, Olivier Collignon, David J. Lawrence, Catey Bunce, Tom Parke, Gus Gazzard, Elizabeth Coates, Marc K. Walton, Sally Hopewell, Philip Pallmann, Thomas Jaki, Katie Biggs, Michael A. Proschan, John A. Scott, Yuki Ando
Two-by-two factorial randomised study within a trial (SWAT) to evaluate strategies for follow-up in a randomised prevention trial
Lucy E. Bradshaw, Alan A. Montgomery, Hywel C. Williams, Joanne R. Chalmers, Rachel H. Haines
Intra-cluster correlation coefficients in primary care patients with type 2 diabetes and hypertension
Yi Lin Lee, Yvonne Mei Fong Lim, Kian Boon Law, Sheamini Sivasampu
Study protocol for daiobotanpito combined with antibiotic therapy for treatment of acute diverticulitis: a study protocol for a randomized controlled trial
Keiko Ogawa-Ochiai, Kenichi Yoshimura, Akiko Shirai, Seisho Sakai, Hideki Moriyama, Keishi Nakamura, Toshinori Murayama, Hideki Ishikawa
IMPROVEjob – Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises – a study protocol of a cluster-randomised controlled trial
Birgitta M. Weltermann, Christine Kersting, Claudia Pieper, Tanja Seifried-Dübon, Annegret Dreher, Karen Linden, Esther Rind, Claudia Ose, Karl-Heinz Jöckel, Florian Junne, Brigitte Werners, Verena Schroeder, Jean-Marie Bois, Achim Siegel, Anika Thielmann, Monika A. Rieger, Stefanie Kasten, M. A. Rieger, E. Rind, A. Siegel, A. Wagner, E. Tsarouha, B. Weltermann, S. Kasten, K. Linden, L. Degen, A. Thielmann, F. Junne, T. Seifried-Dübon, A. Hermann-Werners, F. Stuber, S. Zipfel, B. Werners, M. Grot, K-H Jöckel, C. Pieper, V. Schröder, J-M Bois, A-L Eilerts, M. Brinkmann, C. Kersting, S. Emerich, S. Burgess, M. Hippler, A. Dreher, C. Ose, L. Koppka, J. Block
Fast-track- recovery surgery with a whey-protein-infused carbohydrate-loading drink pre-operatively and early oral feeding post-operatively among surgical gynaecological cancer patients: study protocol of an open-labelled, randomised controlled trial
Chiou Yi Ho, Zuriati Ibrahim, Zalina Abu Zaid, Zulfitri ‘Azuan Mat Daud, Nor Baizura Md Yusop
Non-specific effects of rabies vaccine on the incidence of common infectious disease episodes: study protocol for a randomized controlled trial
Darryn Knobel, Christianah Ibironke Odita, Anne Conan, Donna Barry, Marshalette Smith-Anthony, Juliet Battice, Shianne England, Bradford D. Gessner
Using systematic data categorisation to quantify the types of data collected in clinical trials: the DataCat project
Evelyn Crowley, Shaun Treweek, Katie Banister, Suzanne Breeman, Lynda Constable, Seonaidh Cotton, Anne Duncan, Adel El Feky, Heidi Gardner, Kirsteen Goodman, Doris Lanz, Alison McDonald, Emma Ogburn, Kath Starr, Natasha Stevens, Marie Valente, Gordon Fernie
Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial
Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz, Steven L. Spitalnik, Andrew Eisenberger, Eldad A. Hod, Jessica Justman, Ken Cheung, W. Ian Lipkin, Max R. O’Donnell
Using targeting to recruit men and women of color into a behavioral weight loss trial
Melissa M. Crane, Elisabeth M. Seburg, Rona L. Levy, Robert W. Jeffery, Nancy E. Sherwood
Acupuncture for primary fibromyalgia: Study protocol of a randomized controlled trial
Man Han, Jiakang Cui, Yuya Xiao, Donghong Xiao, Juan Jiao, Qiuwei Peng, Feng Tian, Xiaopo Tang, Jianyong Zhang, Quan Jiang
Statistical analysis plan for a cluster-randomised trial assessing the effectiveness of implementation of a bedside evidence-based checklist for clinical management of brain-dead potential organ donors in intensive care units: DONORS (Donation Network to Optimise Organ Recovery Study)
Natalia Elis Giordani, Caroline Cabral Robinson, Glauco Adrieno Westphal, Regis Goulart Rosa, Daniel Sganzerla, Alexandre Biasi Cavalcanti, Flávia Ribeiro Machado, Luciano Cesar Pontes Azevedo, Fernando Augusto Bozza, Cassiano Teixeira, Joel de Andrade, Cristiano Augusto Franke, Cátia Moreira Guterres, Itiana Cardoso Madalena, Adriane Isabel Rohden, Sabrina Souza da Silva, Luiza Vitelo Andrighetto, Gabriela Soares Rech, Bruna dos Passos Gimenes, Luciano Serpa Hammes, Daniela Ferreira Salomão Pontes, Maureen O. Meade, Maicon Falavigna
Stakeholder perspectives on adaptive clinical trials: a scoping review
Tina Madani Kia, John C. Marshall, Srinivas Murthy
The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study
Kim I. Albers, Fatih Polat, Ivo F. Panhuizen, Marc M. J. Snoeck, Gert-Jan Scheffer, Hans D. de Boer, Michiel C. Warlé
The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial
E. A. Bayliss, S. M. Shetterly, M. L. Drace, J. Norton, A. R. Green, E. Reeve, L. A. Weffald, L. Wright, M. L. Maciejewski, O. C. Sheehan, J. L. Wolff, K. S. Gleason, C. Kraus, M. Maiyani, M. Du Vall, C. M. Boyd
Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials
K. D. Coulman, A. Nicholson, A. Shaw, A. Daykin, L. E. Selman, R. Macefield, G. W. Shorter, H. Cramer, M. R. Sydes, C. Gamble, M. E. Pick, G. Taylor, J. A. Lane
AGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial
Gareth Griffiths, Richard Fitzgerald, Thomas Jaki, Andrea Corkhill, Ellice Marwood, Helen Reynolds, Louise Stanton, Sean Ewings, Susannah Condie, Emma Wrixon, Andrea Norton, Mike Radford, Sara Yeats, Jane Robertson, Rachel Darby-Dowman, Lauren Walker, Saye Khoo
Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, cluster-randomized controlled trial
Mauricio Ceballos, Andrea Salazar-Ospina, Daniel Sabater-Hernández, Pedro Amariles
The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial
Babar Kayani, Sujith Konan, Jenni Tahmassebi, Atif Ayuob, Fares S. Haddad
Efficacy and safety of Zihua Wenfei granules in treatment of postinfectious cough (wind-cold invading lungs syndrome): study protocol for a randomized controlled trial
Huanan Wang, Bin She, Bing Mao, Hongli Jiang
Efficacy and safety of aerosolized intra-tracheal dornase alfa administration in patients with SARS-CoV-2-induced acute respiratory distress syndrome (ARDS): a structured summary of a study protocol for a randomised controlled trial
J. P. Desilles, C. Gregoire, C. Le Cossec, J. Lambert, O. Mophawe, M. R. Losser, F. Lambiotte, S. Le Tacon, M. Cantier, N. Engrand, P. Trouiller, J. Pottecher
Letter to the editor: efficacy of different methods of combination regimen administrations including dexamethasone, intravenous immunoglobulin, and interferon-beta to treat critically ill COVID-19 patients: a structured summary of a study protocol for a randomized controlled trial
Nafiseh Abdolahi, Effat Kaheh, Roghieh Golsha, Behnaz Khodabakhshi, Alireza Norouzi, Mahmoud Khandashpoor, Sima Besharat, Samane Tavassoli, Somayeh Livani, Sadegh Ali Azimi, Mohammad Hadi Gharib, Babak Peivandi, Abdolreza Fazel, Hesamaddin Shirzad-Aski, Gholamreza Roshandel
Efficacy and safety of Dingkun pill for female infertility patients with low prognosis undergoing in vitro fertilization-embryo transfer: study protocol for a multicenter, double-blind, randomized, placebo-controlled trial
Jingyan Song, Ting Ma, Yanlin Liang, Xianling Cao, Zhengao Sun
Timing of antiretroviral therapy for HIV-infected patients with moderate to severe Pneumocystis pneumonia: study protocol for a multi-centre prospective randomised controlled trial
Yuanyuan Qin, Yanqiu Lu, Yihong Zhou, Vijay Harypursat, Feng Sun, Sen Yang, Shengquan Tang, Yao Li, Xiaoqing He, Yanming Zeng, Yaokai Chen
Defining key design elements of registry-based randomised controlled trials: a scoping review
Bill Karanatsios, Khic-Houy Prang, Ebony Verbunt, Justin M. Yeung, Margaret Kelaher, Peter Gibbs
The PRINTEMPS study: protocol of a cluster-randomized controlled trial of the local promotion of a smartphone application and associated website for the prevention of suicidal behaviors in the adult general population in France
Coralie Gandré, Anaïs Le Jeannic, Marie-Amélie Vinet, Kathleen Turmaine, Philippe Courtet, Jean-Luc Roelandt, Guillaume Vaiva, Bruno Giraudeau, Corinne Alberti, Karine Chevreul
Correction to: Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial
Cedric Bosteels, Bastiaan Maes, Karel Van Damme, Elisabeth De Leeuw, Jozefien Declercq, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart N. Lambrecht
Correction to: Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials
Thijs ten Doesschate, Simone J. C. F. M. Moorlag, Thomas W. van der Vaart, Esther Taks, Priya Debisarun, Jaap ten Oever, Chantal P. Bleeker-Rovers, Patricia Bruijning Verhagen, Arief Lalmohamed, Rob ter Heine, Reinout van Crevel, Janneke van de Wijgert, Axel B. Janssen, Marc J. Bonten, Cornelis H. van Werkhoven, Mihai G. Netea
Correction to: Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial
Bastiaan Maes, Cedric Bosteels, Elisabeth De Leeuw, Jozefien Declercq, Karel Van Damme, Anja Delporte, Bénédicte Demeyere, Stéfanie Vermeersch, Marnik Vuylsteke, Joren Willaert, Laura Bollé, Yuri Vanbiervliet, Jana Decuypere, Frederick Libeer, Stefaan Vandecasteele, Isabelle Peene, Bart N. Lambrecht
Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength
Ebaa Al Ozairi, Dalal Alsaeed, Dennis Taliping, Mohamad Jalali, Abeer El Samad, Anant Mashankar, Etab Taghadom, Nicola Guess, Jason M. R. Gill, Naveed Sattar, Cindy Gray, Paul Welsh, Stuart R. Gray
Transcutaneous electrical acupoint stimulation for stage 1 hypertension: protocol for a randomized controlled pilot trial
Zhong-Xue Tian, Cun-Zhi Liu, You-Sheng Qi, Jian-Feng Tu, Ying Lin, Yu Wang, Jing-Wen Yang, Guang-Xia Shi, Jun-Hong Liu, Li-Qiong Wang
Clinical efficacy of ceramic versus resin-based composite endocrowns in Chinese adults: study protocol for a randomized controlled trial
Jilei Wang, Zhiting Ling, Ziting Zheng, Chunqing Zheng, Yawen Gai, Yuting Zeng, Xiaoxia Zhu, Liya Chen, Buling Wu, Wenjuan Yan
Clinical efficacy evaluation of a traditional Miao technique of crossbow needle therapy in the treatment of knee osteoarthritis: a multi-center randomized controlled trial
Jing Fu, Hong-Cai Shang, Li-Ying Wang, Chen Zhao, Xiao-Fang Yang, Wei-Wei Guo, Chun-Xia Lu, Jin Cui, Yan-Ping Wang
Correction to: Impact of phenylalanine on cognitive, cerebral, and neurometabolic parameters in adult patients with phenylketonuria (the PICO study): a randomized, placebo-controlled, crossover, noninferiority trial
Roman Trepp, Raphaela Muri, Stephanie Abgottspon, Lenka Bosanska, Michel Hochuli, Johannes Slotboom, Christian Rummel, Roland Kreis, Regula Everts
Efficacy of a short-term residential smoking cessation therapy versus standard outpatient group therapy (‘START-Study’): study protocol of a randomized controlled trial
Jonas Dickreuter, Claudia Schmoor, Jürgen Bengel, Andreas Jähne, Jens A. Leifert
Efficacy of acupuncture in improving the symptoms and the quality of life of patients with moderate or severe acne vulgaris: study protocol for a randomized controlled trial
Ruimin Jiao, Man Huang, Weina Zhang, Zhishun Liu
Evaluating hearing performance with cochlear implants within the same patient using daily randomization and imaging-based fitting - The ELEPHANT study
L. J. G. Lambriks, M. van Hoof, J. A. Debruyne, M. Janssen, J. Chalupper, K. A. van der Heijden, J. R. Hof, C. A. Hellingman, E. L. J. George, E. M. J. Devocht
The cerebral mechanism of the specific and nonspecific effects of acupuncture based on knee osteoarthritis: study protocol for a randomized controlled trial
Na Zhang, Jin-Ling Li, Chao-Qun Yan, Xu Wang, Lu-Lu Lin, Jian-Feng Tu, You-Sheng Qi, Jun-Hong Liu, Cun-Zhi Liu, Li-Qiong Wang
Effects of soy milk consumption on gut microbiota, inflammatory markers, and disease severity in patients with ulcerative colitis: a study protocol for a randomized clinical trial
Omid Sadeghi, Alireza Milajerdi, Seyed Davar Siadat, Seyed Ali Keshavarz, Ali Reza Sima, Homayoon Vahedi, Peyman Adibi, Ahmad Esmaillzadeh
The relationship between hyperuricemia and contrast-induced acute kidney injury undergoing primary percutaneous coronary intervention: secondary analysis protocol for the ATTEMPT RESCIND-1 study
Wei Guo, Feier Song, Shiqun Chen, Li Zhang, Guoli Sun, Jin Liu, Jiyan Chen, Yong Liu, Ning Tan
Shenhuang granule in the treatment of severe coronavirus disease 2019 (COVID-19): study protocol for an open-label randomized controlled clinical trial
Bangjiang Fang, Wen Zhang, Xinxin Wu, Tingrong Huang, Huacheng Li, You Zheng, Jinhua Che, Shuting Sun, Chao Jiang, Shuang Zhou, Jun Feng
Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2)
Arjun Agarwal, Rukmini Banerji, Peter Boone, Diana Elbourne, Ila Fazzio, Chris Frost, Madan Gopal, Sridevi Karnati, Rakhi Nair, Harshavardhan Reddy, Padmanabh Reddy, Dropti Sharma, Sajjan Singh Shekhawat, Siddharudha Shivalli
Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus
Susanna Dodd, Nicola Harman, Nichole Taske, Mark Minchin, Toni Tan, Paula R. Williamson
FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial
Alexandra Poinas, Marie Lemoigne, Sarah Le Naour, Jean-Michel Nguyen, Solène Schirr-Bonnans, Valery-Pierre Riche, Florence Vrignaud, Laurent Machet, Jean-Paul Claudel, Marie-Thérèse Leccia, Ewa Hainaut, Nathalie Beneton, Cécile Dert, Aurélie Boisrobert, Laurent Flet, Anne Chiffoleau, Stéphane Corvec, Amir Khammari, Brigitte Dréno
Evaluation of the SPIRIT Integrated Suicide Prevention Programme: study protocol for a cluster-randomised controlled trial in rural Gujarat, India
Soumitra Pathare, Laura Shields-Zeeman, Lakshmi Vijayakumar, Deepa Pandit, Renuka Nardodkar, Susmita Chatterjee, Jasmine Kalha, Sadhvi Krishnamoorthy, Nikhil Jain, Arjun Kapoor, Mohammad Shahjahan, Ajay Chauhan, Filip Smit
Triiodothyronine for the treatment of critically ill patients with COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial
Constantinos Pantos, Georgia Kostopanagiotou, Apostolos Armaganidis, Athanasios Trikas, Ioulia Tseti, Iordanis Mourouzis
Randomised controlled trial comparing efficacy and safety of high versus low Low-Molecular Weight Heparin dosages in hospitalized patients with severe COVID-19 pneumonia and coagulopathy not requiring invasive mechanical ventilation (COVID-19 HD): a structured summary of a study protocol
Marco Marietta, Paola Vandelli, Pasquale Mighali, Roberto Vicini, Valeria Coluccio, Roberto D’Amico, Daniela Aschieri, Lucio Brugioni, Enrico Clini, Mauro Codeluppi, Davide Imberti, Andrea Magnacavallo, Marianna Meschiari, Cristina Mussini, Sergio Orlando, Giovanni Pinelli, Antonello Pietrangelo, Luca Sarti, Matteo Silva
Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: a structured summary of a study protocol for a randomised controlled trial
Abolghasem Allahyari, Hossein Rahimi, Majid Khadem-Rezaiyan, Zahra Mozaheb, Mohsen Seddigh-Shamsi, Alireza Bary, Mostafa Kamandi, Sajad Ataei Azimi, Saeed Eslami HasanAbadi, Alireza Noferesti, Somayeh Sadat Shariatmaghani, Houshang Rafatpanah, Shohreh Khatami, Afshin Jabbar Imani, Hassan Mortazi, Mohammad Moeini Nodeh
A prospective, randomized, controlled study assessing vagus nerve stimulation using the gammaCore®-Sapphire device for patients with moderate to severe CoViD-19 Respiratory Symptoms (SAVIOR): A structured summary of a study protocol for a randomised controlled trial”
Carlos Tornero, Ricardo Vallejo, David Cedeño, Jorge Orduña, Ernesto Pastor, Moncef Belaouchi, Benigno Escamilla, Marisa Laredo, María del Mar Garzando
CytoResc – “CytoSorb” Rescue for critically ill patients undergoing the COVID-19 Cytokine Storm: A structured summary of a study protocol for a randomized controlled trial
Helena Stockmann, Theresa Keller, Stefan Büttner, Achim Jörres, Detlef Kindgen-Milles, Julius Valentin Kunz, Josef Leebmann, Claudia Spies, Karl Träger, Sascha Treskatsch, Alexander Uhrig, Carsten Willam, Philipp Enghard, Torsten Slowinski
A novel method for interpreting survival analysis data: description and test on three major clinical trials on cardiovascular prevention
Alessandro Mengozzi, Domenico Tricò, Andrea Natali
The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer
Alessio Crippa, Bram De Laere, Andrea Discacciati, Berit Larsson, Jason T. Connor, Erin E. Gabriel, Camilla Thellenberg, Elin Jänes, Gunilla Enblad, Anders Ullen, Marie Hjälm-Eriksson, Jan Oldenburg, Piet Ost, Johan Lindberg, Martin Eklund, Henrik Grönberg
Postoperative analgesia of scalp nerve block with ropivacaine in pediatric craniotomy patients: a protocol for a prospective, randomized, placebo-controlled, double-blinded trial
Wei Xiong, Lu Li, Di Bao, Yaxin Wang, Yi Liang, Pengwei Lu, Di Zhang, Gaifen Liu, Lanxin Qiao, Na Zheng, Xu Jin
Transmuscular quadratus lumborum (TQL) block for laparoscopic colorectal surgery: study protocol for a double-blind, prospective randomized placebo-controlled trial
Steve Coppens, Steffen Rex, Steffen Fieuws, Arne Neyrinck, Andre D’Hoore, Geertrui Dewinter
Study design of the DAS-OLT trial: a randomized controlled trial to evaluate the impact of dexmedetomidine on early allograft dysfunction following liver transplantation
Chenlu Ni, Joe Masters, Ling Zhu, Weifeng Yu, Yingfu Jiao, Yuting Yang, Cui Cui, Suqing Yin, Liqun Yang, Bo Qi, Daqing Ma
INdividual Vocational and Educational Support Trial (INVEST) for young people with borderline personality disorder: study protocol for a randomised controlled trial
Andrew M. Chanen, Katie Nicol, Jennifer K. Betts, Gary R. Bond, Cathrine Mihalopoulos, Henry J. Jackson, Katherine N. Thompson, Martina Jovev, Hok Pan Yuen, Gina Chinnery, Judith Ring, Kelly Allott, Louise McCutcheon, Ashleigh P. Salmon, Eoin Killackey
Impact of pantoprazole on absorption and disposition of hydroxychloroquine, a drug used in Corona Virus Disease-19 (Covid-19): A structured summary of a study protocol for a randomised controlled trial
Felicitas Stoll, Antje Blank, Gerd Mikus, David Czock, Kathrin I. Foerster, Simon Hermann, Katja Häußler, Amin Muhareb, Simone Hummler, Johanna Weiss, Jürgen Burhenne, Walter E. Haefeli
Effect of pneumoperitoneum pressure and the depth of neuromuscular block on renal function in patients with diabetes undergoing laparoscopic pelvic surgery: study protocol for a double-blinded 2 × 2 factorial randomized controlled trial
Xiaohan Xu, Yahong Gong, Yuelun Zhang, Jiaxin Lang, Yuguang Huang
T-tube drainage versus choledochojejunostomy in hepatolithiasis patients with sphincter of Oddi laxity: study protocol for a randomized controlled trial
Jiang-ming Chen, Xi-yang Yan, Tao Zhu, Zi-xiang Chen, Yi-jun Zhao, Kun Xie, Fu-bao Liu, Xiao-ping Geng
Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study)
Jakob Mechler, Karin Lindqvist, Per Carlbring, Peter Lilliengren, Fredrik Falkenström, Gerhard Andersson, Naira Topooco, Robert Johansson, Nick Midgley, Julian Edbrooke-Childs, Hanne-Sofie J. Dahl, Rolf Sandell, Agneta Thorén, Randi Ulberg, Katja Lindert Bergsten, Björn Philips
Therapeutic pulmonary telerehabilitation protocol for patients affected by COVID-19, confined to their homes: study protocol for a randomized controlled trial
Juan Jose Gonzalez-Gerez, Carlos Bernal-Utrera, Ernesto Anarte-Lazo, Jose Antonio Garcia-Vidal, Jose Martin Botella-Rico, Cleofas Rodriguez-Blanco
The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardised exercise programme or usual care for patients with plantar fasciopathy: study protocol for a double-blind, randomised, sham-controlled trial
Marte Heide, Marianne Mørk, Cecilie Røe, Jens Ivar Brox, Aasne Fenne Hoksrud
Stress ulcer prophylaxis versus placebo—a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD)
Kimberly I. Mills, Ben D. Albert, Lori J. Bechard, Christopher P. Duggan, Aditya Kaza, Seth Rakoff-Nahoum, Hera Vlamakis, Lynn A. Sleeper, Jane W. Newburger, Gregory P. Priebe, Nilesh M. Mehta
The TOTEM RRMS (Testosterone Treatment on neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis) trial: study protocol for a randomized, double-blind, placebo-controlled trial
Katline Metzger-Peter, Laurent Daniel Kremer, Gilles Edan, Paulo Loureiro De Sousa, Julien Lamy, Dominique Bagnard, Ayikoe-Guy Mensah-Nyagan, Thibault Tricard, Guillaume Mathey, Marc Debouverie, Eric Berger, Anne Kerbrat, Nicolas Meyer, Jérôme De Seze, Nicolas Collongues
Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial
Laurie Zawertailo, Christian S. Hendershot, Rachel F. Tyndale, Bernard Le Foll, Andriy V. Samokhvalov, Kevin E. Thorpe, Andrew Pipe, Robert D. Reid, Peter Selby
Folic acid supplementation in children with sickle cell disease: study protocol for a double-blind randomized cross-over trial
Brock A. Williams, Heather McCartney, Erin Adams, Angela M. Devlin, Joel Singer, Suzanne Vercauteren, John K. Wu, Crystal D. Karakochuk
The Melanoma Genomics Managing Your Risk Study randomised controlled trial: statistical analysis plan
Serigne N. Lo, Amelia K. Smit, David Espinoza, Anne E. Cust, Anne E. Cust, Ainsley J. Newson, Rachael L. Morton, Michael Kimlin, Louise Keogh, Matthew H. Law, Judy Kirk, Suzanne J. Dobbinson, Peter A. Kanetsky, Graham J. Mann, Hugh Dawkins, Jacqueline Savard, Kate Dunlop, Lyndal Trevena, Mark Jenkins, Martin Allen, Phyllis Butow, Sarah Wordsworth, Serigne N. Lo, Cynthia Low, Amelia Smit, David Espinoza
The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular retrognathia: study protocol for a multicenter randomized controlled trial
Yuanyuan Li, Jiali Wu, Jinghan Guo, Liming Yu, Jing Wang, Xiaoyan Li, Shuhua Xu, Min Zhu, Jinqiu Feng, Yuehua Liu
E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan
Jennifer L. Bell, Pollyanna Hardy, Melanie Greenland, Edmund Juszczak, Christina Cole, Abha Maheshwari, Siladitya Bhattacharya, Louise Linsell
The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: protocol for a randomized, double-blind, placebo-controlled, multicenter trial
Tao Bai, Haoyu Zeng, Yanqin Long, Xiaoqing Li, Xiaohong Sun, Yu Lan, Lingling Gao, Lu Zhang, Zenghui Feng, Xiaohua Hou
Effectiveness and cost-effectiveness of a community-based mental health care programme (GBV) for people with severe mental illness in Germany: study protocol for a randomised controlled trial
Annabel Sandra Mueller-Stierlin, Friedrich Meixner, Anne Kohlmann, Mara Schumacher, Anke Hänsel, Melanie Pouwels, Nicole Bias, Sabrina Hartl, Jessica Reichstein, Elke Prestin, Nils Greve, Thomas Becker, Reinhold Kilian
Development of a core outcome set for oral health services research involving dependent older adults (DECADE): a study protocol
Sinead Watson, Julie McMullan, Paul Brocklehurst, Georgios Tsakos, Richard G. Watt, Rebecca R. Wassall, Andrea Sherriff, Sheena E. Ramsay, Anup J. Karki, Sayaka Tada, Caroline Lappin, Michael Donaldson, Gerald McKenna
TILT: Time-Lapse Imaging Trial—a pragmatic, multi-centre, three-arm randomised controlled trial to assess the clinical effectiveness and safety of time-lapse imaging in in vitro fertilisation treatment
Priya Bhide, Arasaratnam Srikantharajah, Doris Lanz, Julie Dodds, Bonnie Collins, Javier Zamora, David Chan, Shakila Thangaratinam, Khalid S. Khan
The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial—study protocol for a randomized controlled trial
Matthieu Legrand, Hafid Ait Oufella, Daniel De Backer, Jacques Duranteau, Marc Leone, Bruno Levy, Patrick Rossignol, Eric Vicaut, François Dépret, François Depret, Jean-Michel Constantin, Hafid Ait Oufella, Daniel De Backer, Bruno Levy, Marc Leone, Jacques Dureanteau, Samuel Gaugain, Jules Audart, Jean-Yves Lefrant, Bruno Megarbane, Julien Pottecher, Romain Sonneville, Thomas Rimmele, Carole Ichai, Antoine Vieillard, Alexy Tran Dinh, Cécile Aubron, Arnaud Mari, Vincent Labbe, Gaetan Plantefeve, Anne Laure Fedou, Damien Barraud, Stéphane Gaudry, Helene Nougue
Effect of voluntary breathing exercises on stable coronary artery disease in heart rate variability and rate-pressure product: a study protocol for a single-blind, prospective, randomized controlled trial
Qing Wu, Lin Liu, Xin Jiang, Yao-Yao Hu, Qiu-Shi Liang, Zhi-Song He, Yuan Xue, Wei Zhu, Zai-Xiang Tang, Yun-Ying Hou, Qi Zhao, Xiao-Hua Wang
Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial)
Yang Yang, Yuchen Su, Xiaobin Zhang, Jun Liu, Hong Zhang, Bin Li, Rong Hua, Lijie Tan, Hezhong Chen, Zhigang Li
ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial
Carmel M. McEniery, Marie Fisk, Karen Miles, Fotini Kaloyirou, Annette Hubsch, Jane Smith, Ian B. Wilkinson, Joseph Cheriyan
Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial
Daniela Francescato Veiga, Edgard da Silva Garcia, José Wilson Moreira-Filho, Evelyne Borges de Mattos Andrade, Yara Juliano, Joel Veiga-Filho, Lydia Masako Ferreira
Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study
Julian Doll, Stefan Waizenegger, Thomas Bruckner, Gerhard Schmidmaier, Sebastian I. Wolf, Christian Fischer
Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial
Raquel González, Laura García-Otero, Clara Pons-Duran, Elena Marbán-Castro, Anna Goncé, Elisa Llurba, Maria del Mar Gil, Miguel Ángel Rodríguez-Zambrano, Haily Chen, Máximo Ramírez, Azucena Bardají, Clara Menendez
Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial
Mohamad Hadi El Charif, Zeina Hassan, Jamal Hoballah, Mohamad Khalife, Eman Sbaity
The curative effects of shortwave diathermy on treating Novel coronavirus (COVID-19) pneumonia: A structured summary of a study protocol for a randomised controlled trial
Mohammad Nasb, Zulfiqar Ali Sayed Shah, Liangjiang Huang, Qian Li, Hong Chen
Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial
Atsushi Kawaguchi, Gabrielle Bernier, Jacques Lacroix, Saly El Salti, Matthew P. Cheng, Todd C. Lee, Kosar Khwaja, Philippe Jouvet
Oral medicinal cannabinoids to relieve symptom burden in the palliative care of patients with advanced cancer: a double-blind, placebo-controlled, randomised clinical trial of efficacy and safety of 1:1 delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
Janet Hardy, Alison Haywood, Gauri Gogna, Jennifer Martin, Patsy Yates, Ristan Greer, Phillip Good
Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: study protocol for a randomized controlled trial
Delphine Meier-Girard, Karin Ribi, Gisa Gerstenberg, Thomas Ruhstaller, Ursula Wolf
Impact of vitamins A, B, C, D, and E supplementation on improvement and mortality rate in ICU patients with coronavirus-19: a structured summary of a study protocol for a randomized controlled trial
Mohammad Taghi Beigmohammadi, Sama Bitarafan, Azin Hoseindokht, Alireza Abdollahi, Laya Amoozadeh, Maedeh Mahmoodi Ali Abadi, Morteza Foroumandi
Registration of phase 3 crossover trials on ClinicalTrials.gov
Lijuan Zeng, Riaz Qureshi, Shilpa Viswanathan, Lea Drye, Tianjing Li
Brief educational video plus telecare to enhance recovery for older emergency department patients with acute musculoskeletal pain: study protocol for the BETTER randomized controlled trial
Timothy F. Platts-Mills, Samuel A. McLean, Morris Weinberger, Sally C. Stearns, Montika Bush, Brittni B. Teresi, Karen Hurka-Richardson, Kurt Kroenke, Robert D. Kerns, Mark A. Weaver, Francis J. Keefe
Effects of a novel nutraceutical combination (BruMeChol™) in subjects with mild hypercholesterolemia: study protocol of a randomized, double-blind, controlled trial
Anna Rita Bonfigli, Olga Protic, Fabiola Olivieri, Alberto Montesanto, Gelsomina Malatesta, Raffaele Di Pillo, Roberto Antonicelli
Transcutaneous electrical acupuncture stimulation (TEAS) for gastrointestinal dysfunction in adults undergoing abdominal surgery: study protocol for a prospective randomized controlled trial
Ya-Fan Bai, Chao Gao, Wen-Jing Li, Yi Du, Li-Xin An
Effects of intraoperative individualized PEEP on postoperative atelectasis in obese patients: study protocol for a prospective randomized controlled trial
Chen Zhu, Jing-Wen Yao, Li-Xin An, Ya-Fan Bai, Wen-Jing Li
Stepped-wedge cluster randomised trial of a smoking cessation counselling training programme for midwives treating women with functional health illiteracy and low socioeconomic status (PROMISE): a study protocol
Jeroen Bommelé, Linda Springvloet, Naïma Abouri, Karianne Djoyoadhiningrat-Hol, Margriet van Laar, Matthijs Blankers
Outcome reporting recommendations for clinical trial protocols and reports: a scoping review
Nancy J. Butcher, Emma J. Mew, Andrea Monsour, An-Wen Chan, David Moher, Martin Offringa
Association between recipient survival and blood donor age after blood transfusion in a surgery intensive care unit: a multicenter randomized controlled trial study protocol
Xianfei Zeng, Yan Liao, Xiaoshuang Wu, Jinmei Xu, Chenxing Da, Zhijun Tan, Fan Feng, Wen Yin, Dongjian Wang, Xingbin Hu
Efficacy of chloroquine versus lopinavir/ritonavir in mild/general COVID-19 infection: a prospective, open-label, multicenter, randomized controlled clinical study
Xi Liu, Huili Chen, Yuqi Shang, Hongqiong Zhu, Gongqi Chen, Yuanli Chen, Shaoxuan Liu, Yaoyong Zhou, Mingxing Huang, Zhongsi Hong, Jinyu Xia
Evaluating interventions to improve test, treat, and track (T3) malaria strategy among over-the-counter medicine sellers (OTCMS) in some rural communities of Fanteakwa North district, Ghana: study protocol for a cluster randomized controlled trial
Olajoju Temidayo Soniran, Benjamin Abuaku, Collins Stephen Ahorlu
Protocol for a randomized controlled trial to assess two procedures of vaginal native tissue repair for pelvic organ prolapse at the time of the questioning on vaginal prosthesis: the TAPP trial
A. Lacorre, F. Vidal, S. Campagne-Loiseau, B. Marin, Y. Aubard, F. Siegerth, C. Mesnard, E. Chantalat, C. Hocke, T. Gauthier
Generate-Boost: study protocol for a prospective, multicenter, randomized controlled, double-blinded phase II trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis
Jonathan Wickel, Ha-Yeun Chung, Stephanie Platzer, Thomas Lehmann, Harald Prüss, Frank Leypoldt, Albrecht Günther, André Scherag, Christian Geis
Repurposed immunomodulatory drugs for Covid-19 in pre-ICu patients - mulTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19 – Repurposed Drugs (TACTIC-R): A structured summary of a study protocol for a randomised controlled trial
Spoorthy Kulkarni, Marie Fisk, Michalis Kostapanos, Edward Banham-Hall, Simon Bond, Elena Hernan-Sancho, Sam Norton, Joseph Cheriyan, Andrew Cope, James Galloway, Frances Hall, David Jayne, Ian B. Wilkinson
Impacts of chest compression cycle length and real-time feedback with a CPRmeter® on chest compression quality in out-of-hospital cardiac arrest: study protocol for a multicenter randomized controlled factorial plan trial
Clément Buléon, Jean-Jacques Parienti, Elodie Morilland-Lecoq, Laurent Halbout, Eric Cesaréo, Pierre-Yves Dubien, Benoit Jardel, Christophe Boyer, Kévin Husson, Florian Andriamirado, Xavier Benet, Emmanuel Morel-Marechal, Antoine Aubrion, Catalin Muntean, Erwan Dupire, Eric Roupie, Hervé Hubert, Christian Vilhelm, Pierre-Yves Gueugniaud
Effect of preoperative immunonutrition on outcomes of colon cancer surgery: study protocol for a randomized controlled trial
Soo Young Lee, Seung-Seop Yeom, Chang Hyun Kim, Hyeong Rok Kim
The implementation and utility of patient screening logs in a multicentre randomised controlled oncology trial
Rebecca Lewis, Rachel Todd, Michelle Newton, Robert J. Jones, Caroline Wilson, Jenny L. Donovan, Richard T. Bryan, Alison Birtle, Emma Hall
Efficacy and safety of the extracorporeal shockwave therapy in patients with postherpetic neuralgia: study protocol of a randomized controlled trial
Lu Chen, Ruihao Zhou, Fuguo Sun, Yan Weng, Ling Ye, Pingliang Yang
Azithromycin added to hydroxychloroquine for patients admitted to intensive care due to coronavirus disease 2019 (COVID-19)—protocol of randomised controlled trial AZIQUINE-ICU
František Duška, Petr Waldauf, Milada Halačová, Václav Zvoníček, Jakub Bala, Martin Balík, Jan Beneš, Olga Klementová, Irena Kozáková, Viktor Kubricht, Anne Le Roy, Tomáš Vymazal, Veronika Řehořová, Vladimír Černý
Outpatient treatment of COVID-19 with steroids in the phase of mild pneumonia without the need for admission as an opportunity to modify the course of the disease: A structured summary of a randomised controlled trial
Miriam Saiz-Rodríguez, Teresa Peña, Lourdes Lázaro, Ángel González, Andrés Martínez, José A. Cordero, Juan T. Vicente, Fernando Richard, María Jesús Coma, Martín de Frutos, Jorge Labrador, Ana Pueyo
Effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes mellitus: study protocol for a randomized controlled trial
George Asimakopoulos, Vasilios Pergialiotis, Eleni Anastasiou, Panagiotis Antsaklis, Mariana Theodora, Evangelia Vogiatzi, Aggela Kallergi, Michael Sindos, Dimitrios Loutradis, George Daskalakis
Using metagenomic analysis to assess the effectiveness of oral health promotion interventions in reducing risk for pneumonia among patients with stroke in acute phase: study protocol for a randomized controlled trial
Juncang Wu, Yuanchang Dai, Edward C. M. Lo, Yinliang Qi, Ya Zhang, Quan-li Li, Ruoxi Dai
Test and treat COVID 65 plus - Hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of older patients with COVID19: A structured summary of a study protocol for a randomised controlled trial
Siri Göpel, Wolfgang Bethge, Peter Martus, Florian Kreth, Thomas Iftner, Stefanie Joos, Stefanie Döbele, Benjamin Mordmüller, Peter Kremsner, Thomas Ettrich, Thomas Seufferlein, Michael Bitzer, Nisar Malek
Impact of a smartphone application (KAIA COPD app) in combination with Activity Monitoring as a maintenance prOgram following PUlmonary Rehabilitation in COPD: the protocol for the AMOPUR Study, an international, multicenter, parallel group, randomized, controlled study
Marc Spielmanns, Tobias Boeselt, Stephan Huber, Pawandeep Kaur Bollinger, Bernhard Ulm, Anna-Maria Peckaka-Egli, Inga Jarosch, Tessa Schneeberger, Sabine Schoendorf, Rainer Gloeckl, A. Rembert Koczulla
Effects of high-protein diet combined with exercise to counteract frailty in pre-frail and frail community-dwelling older adults: study protocol for a three-arm randomized controlled trial
Sussi F. Buhl, Anne Marie Beck, Britt Christensen, Paolo Caserotti
The effect of a pre- and post-operative exercise programme versus standard care on physical fitness of patients with oesophageal and gastric cancer undergoing neoadjuvant treatment prior to surgery (The PERIOP-OG Trial): Study protocol for a randomised controlled trial
Roisin Tully, Lisa Loughney, Jarlath Bolger, Jan Sorensen, Oliver McAnena, Chris G. Collins, Paul A. Carroll, Mayilone Arumugasamy, Tomas J. Murphy, William B. Robb, Wendy Hickey, Claire Coleman, Louise Buckley, Eileen Lombard, Noel McCaffrey, Pamela Gallagher, Claire Timon, Patricia Kearney, Aoife Quinn, Emma Houlihan, D. J. O’Dwyer, Catherine Woods, Raymond O’Connor, Sinead Kelly, Brona Kehoe, Mark McManus, Austin Twomey
A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome: A structured summary of a study protocol for a randomised controlled trial
Keisha Smith, Amy Pace, Stephan Ortiz, Shamsah Kazani, Scott Rottinghaus
Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial
Junhao Zhu, Chao Tang, Zixiang Cong, Jin Yang, Xiangming Cai, Yuxiu Liu, Chiyuan Ma
Correction to: ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial
Carmel M. McEniery, Marie Fisk, Karen Miles, Fotini Kaloyirou, Annette Hubsch, Jane Smith, Ian B. Wilkinson, Joseph Cheriyan
Where is an emotion? Using targeted visceroception as a method of improving emotion regulation in healthy participants to inform suicide prevention initiatives: a randomised controlled trial
Steven Davey, Elliot Bell, Jamin Halberstadt, Sunny Collings
Randomized placebo-controlled clinical trial investigating the effect of antioxidants and a vasodilator on overall safety and residual hearing preservation in cochlear implant patients
Verena Scheper, Melanie Schmidtheisler, Florian Lasch, Heiko von der Leyen, Armin Koch, Jana Schwieger, Andreas Büchner, Anke Lesinski-Schiedat, Thomas Lenarz
Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design
Vicky Chalos, Rob A. van de Graaf, Bob Roozenbeek, Adriaan C. G. M. van Es, Heleen M. den Hertog, Julie Staals, Lukas van Dijk, Sjoerd F.M. Jenniskens, Robert J. van Oostenbrugge, Wim H. van Zwam, Yvo B.W.E.M. Roos, Charles B.L.M. Majoie, Hester F. Lingsma, Aad van der Lugt, Diederik W.J. Dippel, Diederik Dippel, Aad van der Lugt, Bob Roozenbeek, Vicky Chalos, Rob van de Graaf, Wouter van der Steen, Adriaan van Es, Jonathan Coutinho, Bart Emmer, Inger de Ridder, Wim van Zwam, Bart van der Worp, Rob Lo, Koos Keizer, Rob Gons, Lonneke Yo, Jelis Boiten, Ido van den Wijngaard, Jeanette Hofmeijer, Jasper Martens, Wouter Schonewille, Jan Albert Vos, Anil M. Tuladhar, Sjoerd Jenniskens, Karlijn de Laat, Lukas van Dijk, Heleen den Hertog, Boudewijn van Hasselt, Paul Brouwers, Emiel Sturm, Michel Remmers, Thijs de Jong, Anouk Rozeman, Otto Elgersma, Maarten Uyttenboogaart, Reinoud P. H. Bokkers, Julia van Tuijl, Issam Boukrab, Julie Staals, Yvo Roos, Charles Majoie, Robert van Oostenbrugge, Peter Rothwell, Andrew Molyneux, Joanna Moschandreas, Daan Nieboer, Gregory del Zoppo, Rick van Nuland, Alida Annechien Postma, René van den Berg, Ludo Beenen, Pieter-Jan van Doormaal, Geert Lycklama, Albert Yoo, Sebastiaan Hammer, Stefan Roosendaal, Anton Meijer, Menno Krietemeijer, Anouk van der Hoorn, Dick Gerrits, Ben Jansen, Sanne Manschot, Henk Kerkhoff, Peter Koudstaal, Hester Lingsma, Olvert Berkhemer, Adriaan Versteeg, Lennard Wolff, Jiahang Su, Hugo ten Cate, Moniek de Maat, Samantha Donkel, Heleen van Beusekom, Aladdin Taha, Kilian Treurniet, Sophie van den Berg, Natalie LeCouffe, Robert-Jan Goldhoorn, Wouter Hinsenveld, Anne Pirson, Lotte Sondag, Manon Kappelhof, Rik Reinink, Manon Tolhuisen, Josje Brouwer, Sabine Collette, Simone Uniken Venema, Susan Olthuis, Floor Pinkaers, Martin Sterrenberg, Naziha El Ghannouti, Sabrina Verheesen, Rita Sprengers, Wilma Pellikaan, Yvonne Drabbe, Joke de Meris, Michelle Simons, Hester Bongenaar, Anja van Loon, Eva Ponjee, Rieke Eilander, Suze Kooij, Marieke de Jong, Esther Santegoets, Friedus van der Minne, Leontien Heiligers, Yvonne Martens
Effect of intraoperative dexmedetomidine infusion on delirium in adult patients following cardiac valve surgery: a protocol of a randomized, double-blinded, and placebo-controlled study
Hong-Bai Wang, Liang Zhang, Zhe Zhang, Su Yuan, Fu-Xia Yan, Qi-Peng Luo
The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial
Justin T. Denholm, Joshua Davis, David Paterson, Jason Roberts, Susan Morpeth, Thomas Snelling, Dominica Zentner, Megan Rees, Matthew O’Sullivan, David Price, Asha Bowen, Steven Y. C. Tong, Joshua Davis, Justin Denholm, Steven Tong, Megan Rees, David Paterson, David Price, Susan Morpeth, Matthew O’Sullivan, Jason Roberts, Thomas Snelling, Sue Anderson, Zoe McQuilton, Bala Venkatesh, Naomi Hammond, Vivekanend Jha, Victoria John Burston, James McMahon, Patrick Charles, Robert Commons, Daniel O’Brien, Andrew Mahoney, David Sheffield, Lyn-Li Lim, Brad Gardiner, Thomas Schulz, Joseph Torresi, Roy Chean, Joseph Sasadeusz, Ben Rogers, Craig Aboltins, Kasha Singh, Michelle Yong, David Lister, Kumar Visvanathan, James Molton, Alex Tai, Rachel Chalmers, Marianne Martinello, Paul Wilson, Timothy Gray, Sarah Coghill, Hong Foo, Archana Sud, Jacob Williams, Nilar Lwin, Jeffrey Post, Sebastian van Haal, Richard Sullivan, Gail Matthews, Benjamin Chi Hin Kwan, Andrew Slack, Omar Shum, Belinda Cochrane, Ravindra Dotel, Timothy Gray, Timothy Gilbey, Michael Mina, Yuen Su, Chris Trethewy, Bernie Hudson, Arunavo Chatterji, Christaan Mostert, David New, Edward Raby, Sionh Hui, Owen Robinson, Julie Hart, Shu Jin Tan, Astrid Arellano, Jonathan Chambers, Jane Davis, Nastaran Rafiei, Simon Smith, Marjoree Sehu, Janath da Silva, Paul Griffin, Andrew Henderson, Khin Chaw, Keat Choong, Andrew Burke, Christopher Heather, Sanjaya Senanayake, Mark Boyd, Emily Rowe, Mick Anagnostou, Ali Trad, Alison Ratcliff, Susan Morpeth, Jack Dummer, Hassan Bhally, Massimo Giola, Kate Grimwade, Catharina Li-Lin Chang, Ayesha Verrall, Stephen Hogg, Dalilah Restropo, Michael Maze, Stephen Ritchie, Craig Gedye, Judy Chang, Michael Maze, Priyanka Pillai, Katie Flanagan, Jocelyn Mora, Jenny Post, Eileen Lam, Roberta Littleford, Naomi Knoblauch, Sandy Slow
Protecting Frontline Health Care Workers from COVID-19 with Hydroxychloroquine Pre-exposure Prophylaxis: A structured summary of a study protocol for a randomised placebo-controlled multisite trial in Toronto, Canada
Julie K. Wright, Darrell H. S. Tan, Sharon L. Walmsley, Jennifer Hulme, Erin O’Connor, Carolyn Snider, Ivy Cheng, Adrienne K. Chan, Bjug Borgundvaag, Shelley McLeod, Michael H. Gollob, Rosemarie J. Clarke, Linda Dresser, Fatima Haji, Tony Mazzulli, Samira Mubareka, Peter Jüni, Dominic Lee, George Tomlinson, Kevin C. Kain, Megan Landes
Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial
Ka Sing Paris Lai, Christine Watt, Emily Ionson, Imants Baruss, Cheryl Forchuk, Javeed Sukhera, Amer M. Burhan, Akshya Vasudev
Effects of Supervised Early Resistance Training versus standard care on cognitive recovery following cardiac surgery via median sternotomy (the SEcReT study): protocol for a randomised controlled pilot study
Jacqueline M. S. Pengelly, Alistair G. Royse, Adam L. Bryant, Gavin P. Williams, Lynda J. Tivendale, Timothy J. Dettmann, David J. Canty, Colin F. Royse, Doa A. El-Ansary
Correction to: Protocol for a randomised controlled trial to investigate the effect of home- and gym-based resistance exercise training on glycaemic control, body composition and muscle strength
Ebaa Al Ozairi, Dalal Alsaeed, Dennis Taliping, Mohamad Jalali, Abeer El Samad, Anant Mashankar, Etab Taghadom, Nicola Guess, Jason M. R. Gill, Naveed Sattar, Cindy Gray, Paul Welsh, Stuart R. Gray
A Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly (CROSSFIRE): a statistical analysis plan
Andrew Lawson, Justine Naylor, Rachelle Buchbinder, Rebecca Ivers, Zsolt Balogh, Paul Smith, Rajat Mittal, Wei Xuan, Kirsten Howard, Arezoo Vafa, Piers Yates, Bertram Rieger, Geoff Smith, Ilia Elkinson, Woosung Kim, Jai Sungaran, Kim Latendresse, James Wong, Sameer Viswanathan, Keith Landale, Herwig Drobetz, Phong Tran, Richard Page, Raphael Hau, Jonathan Mulford, Ian Incoll, Michael Kale, Bernard Schick, Andrew Higgs, Andrew Oppy, Diana Perriman, Ian Harris
Safety and efficacy of belimumab after B cell depletion therapy in systemic LUPUS erythematosus (BEAT-LUPUS) trial: statistical analysis plan
Patrick Muller, Kashfia Chowdhury, Caroline Gordon, Michael R. Ehrenstein, Caroline J. Doré
Process evaluation of a complex intervention to promote advance care planning in community-dwelling older persons (the STADPLAN study)—study protocol
Katharina Silies, Rieke Schnakenberg, Almuth Berg, Änne Kirchner, Henriette Langner, Juliane Köberlein-Neu, Gabriele Meyer, Falk Hoffmann, Sascha Köpke
eTest: a limited-interaction, longitudinal randomized controlled trial of a mobile health platform that enables real-time phone counseling after HIV self-testing among high-risk men who have sex with men
Tyler B. Wray, Philip A. Chan, Jeffrey D. Klausner, Leandro A. Mena, James B. Brock, Erik M. Simpanen, Lori M. Ward, Stafylis Chrysovalantis
A trauma medical home, evaluating collaborative care for the older injured patient: study protocol for a randomized controlled trial
Damaris Ortiz, Ashley D. Meagher, Heidi Lindroth, Emma Holler, Sujuan Gao, Babar Khan, Sue Lasiter, Malaz Boustani, Ben Zarzaur
Report of a Delphi exercise to inform the design of a research programme on screening for thoracic aortic disease
R. G. Abbasciano, J. Barwell, R. Sayers, M. Bown, D. Milewicz, G. Cooper, G. Mariscalco, N. Wheeldon, C. Fowler, G. Owens, G. J. Murphy, Graham Cooper, Catherine Fowler, Mark Callaway, Rajesh Chelliah, Aparna Deshpande, Jeffrey Khoo, Gerry McCann, Praveen Rao, Matthew Bown, Dianna Milewicz, Huw Dorkins, Mark Field, Catherine Fletcher-Francis, Cliff Grover, Giovanni Mariscalco, Toru Suzuki, Amy Yasbeck, Julian Barwell, Karen English, Noelle Robertson, Anne Cotton, Sarah Gunn, Victoria McKay, Aung Oo, Deborah Osio, Nora Shannon, Saba Sharif, Nigel Wheeldon, Rob Sayers, Gareth Owens, Michael Sweeting, Cassandra Brookes, Tracy Kumar, Florence Lai, Gavin Murphy
Whey protein supplementation reducing fasting levels of anandamide and 2-AG without weight loss in pre-menopausal women with obesity on a weight-loss diet
Fatemeh Haidari, Vahideh Aghamohammadi, Majid Mohammadshahi, Kambiz Ahmadi-Angali, Mohammad Asghari-Jafarabadi
Nocebo effects and participant information leaflets: evaluating information provided on adverse effects in UK clinical trials
Nigel Kirby, Victoria Shepherd, Jeremey Howick, Sophie Betteridge, Kerenza Hood
Clinical study protocol for a low-interventional study in intermediate age-related macular degeneration developing novel clinical endpoints for interventional clinical trials with a regulatory and patient access intention—MACUSTAR
Jan H. Terheyden, Frank G. Holz, Steffen Schmitz-Valckenberg, Anna Lüning, Matthias Schmid, Gary S. Rubin, Hannah Dunbar, Adnan Tufail, David P. Crabb, Alison Binns, Clara I. Sánchez, Carel Hoyng, Philippe Margaron, Nadia Zakaria, Mary Durbin, Ulrich Luhmann, Parisa Zamiri, José Cunha-Vaz, Cecília Martinho, Sergio Leal, Robert P. Finger, P. Basile, C. Behning, M. Berger, A. Binns, M. Böttger, C. Bouchet, J. E. Brazier, T. Butt, C. Carapezzi, J. Carlton, A. Charil, R. Coimbra, S. Nunes, D. Crabb, J. Cunha-Vaz, H. Dunbar, M. Durbin, R. Finger, F. Holz, C. Hoyng, J. Krätzschmar, S. Leal, U. Luhmann, A. Lüning, Ph. Margaron, C. Martinho, B. Melício, S. Mohand-Saïd, D. Rowen, G. S. Rubin, J. Sahel, C. I. Sánchez, D. Sanches Fernandes, M. Schmid, S. Schmitz-Valckenberg, A. Skelly, L. Stöhr, D. Taylor, J. Terheyden, A. Tufail, L. Vieweg, L. Wintergerst, C. Wojek, N. Zakaria, P. Zamiri
Correction to: Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer’s disease: study protocol for a randomised controlled trial (ELAD study)
Grazia Daniela Femminella, Eleni Frangou, Sharon B. Love, Gail Busza, Clive Holmes, Craig Ritchie, Robert Lawrence, Brady McFarlane, George Tadros, Basil H. Ridha, Carol Bannister, Zuzana Walker, Hilary Archer, Elizabeth Coulthard, Ben R. Underwood, Aparna Prasanna, Paul Koranteng, Salman Karim, Kehinde Junaid, Bernadette McGuinness, Ramin Nilforooshan, Ajay Macharouthu, Andrew Donaldson, Simon Thacker, Gregor Russell, Naghma Malik, Vandana Mate, Lucy Knight, Sajeev Kshemendran, John Harrison, Christian Hölscher, David J. Brooks, Anthony Peter Passmore, Clive Ballard, Paul Edison
Impact of receiving recorded mental health recovery narratives on quality of life in people experiencing psychosis, people experiencing other mental health problems and for informal carers: Narrative Experiences Online (NEON) study protocol for three randomised controlled trials
Stefan Rennick-Egglestone, Rachel Elliott, Melanie Smuk, Clare Robinson, Sylvia Bailey, Roger Smith, Jeroen Keppens, Hannah Hussain, Kristian Pollock, Pim Cuijpers, Joy Llewellyn-Beardsley, Fiona Ng, Caroline Yeo, James Roe, Ada Hui, Lian van der Krieke, Rianna Walcott, Mike Slade
Use of olanzapine to treat agitation in traumatic brain injury: study protocol for a randomised controlled trial
Ruby K Phyland, Adam McKay, John Olver, Mark Walterfang, Malcolm Hopwood, Amelia J Hicks, Duncan Mortimer, Jennie L Ponsford
Effectiveness of the level of personal relevance of visual autobiographical stimuli in the induction of positive emotions in young and older adults: pilot study protocol for a randomized controlled trial
Dolores Fernández, Laura Ros, Roberto Sánchez-Reolid, Jorge Javier Ricarte, José Miguel Latorre
Internet-based cognitive rehabilitation for WORking Cancer survivors (i-WORC): study protocol of a randomized controlled trial
Kete M. Klaver, Saskia F. A. Duijts, Chantal A. V. Geusgens, Maureen J. B. Aarts, Rudolf W. H. M. Ponds, Allard J. van der Beek, Sanne B. Schagen
Adaptive interventions for optimizing malaria control: an implementation study protocol for a block-cluster randomized, sequential multiple assignment trial
Guofa Zhou, Ming-chieh Lee, Harrysone E. Atieli, John I. Githure, Andrew K. Githeko, James W. Kazura, Guiyun Yan
Efficacy of local budesonide therapy in the management of persistent hyposmia in COVID-19 patients without signs of severity: A structured summary of a study protocol for a randomised controlled trial
Mary Daval, Alain Corré, Clement Palpacuer, Juliette Housset, Guillaume Poillon, Michael Eliezer, Benjamin Verillaud, Dorsaf Slama, Denis Ayache, Philippe Herman, Clement Jourdaine, Camille Hervé, Wissame El Bakkouri, Dominique Salmon, Charlotte Hautefort
Better Outcomes for Older people with Spinal Trouble (BOOST) trial: statistical analysis plan for a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication
Ioana R. Marian, Esther Williamson, Angela Garrett, Sarah E. Lamb, Susan J. Dutton
Overrunning in clinical trials: some thoughts from a methodological review
Ileana Baldi, Danila Azzolina, Nicola Soriani, Beatrice Barbetta, Paola Vaghi, Giampaolo Giacovelli, Paola Berchialla, Dario Gregori
Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial
Weiming Hao, Liping Zhao, Huiqian Yu, Huawei Li
Treatment fidelity in the Tinnitus Retraining Therapy Trial
Roberta W. Scherer, Sue Ann Erdman, Susan Gold, Craig Formby
A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?
M. Mitroiu, K. Oude Rengerink, S. Teerenstra, F. Pétavy, K. C. B. Roes
Community Tele-pal: A community-developed, culturally based palliative care tele-consult randomized controlled trial for African American and White Rural southern elders with a life-limiting illness
Kristen Allen Watts, Shena Gazaway, Emily Malone, Ronit Elk, Rodney Tucker, Susan McCammon, Michele Goldhagen, Jacob Graham, Veronica Tassin, Joshua Hauser, Sidney Rhoades, Marjorie Kagawa-Singer, Eric Wallace, James McElligott, Richard Kennedy, Marie Bakitas
Efficacy of brief dynamic interpersonal therapy in patients with major depressive disorder: a prospective, multicenter randomized controlled trial protocol
Lanlan Wang, Qian Wang, Wenhui Jiang, Jianfeng Luo, Jun Tong, Xiaosi Li, Fang Fang, Hongyan Wang, Wenqing Zhao, Diana Koszycki, Jianyin Qiu
Communities for Healthy Living (CHL) A Community-based Intervention to Prevent Obesity in Low-Income Preschool Children: Process Evaluation Protocol
Jacob P. Beckerman-Hsu, Alyssa Aftosmes-Tobio, Adam Gavarkovs, Nicole Kitos, Roger Figueroa, Z. Begum Kalyoncu, Kindra Lansburg, Xinting Yu, Crystal Kazik, Adrienne Vigilante, Jessie Leonard, Merieka Torrico, Janine M. Jurkowski, Kirsten K. Davison
Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
Ramtin Talebi, Rita F. Redberg, Joseph S. Ross
Ursodeoxycholic acid for the prevention of symptomatic gallstone disease after bariatric surgery: statistical analysis plan for a randomised controlled trial (UPGRADE trial)
Sylke Haal, Maimoena S. S. Guman, L. Maurits de Brauw, Ruben N. van Veen, Ruben Schouten, Paul Fockens, Victor E. A. Gerdes, Marcel G. W. Dijkgraaf, Rogier P. Voermans
Rationale and design of individualized quality improvement based on the Computer Analysing system to improve Stroke management quality Evaluation (CASE): a multicenter historically controlled study
Yi Chen, Wansi Zhong, Xiaoxian Gong, Haitao Hu, Shenqiang Yan, Xuting Zhang, Zhicai Chen, Ying Zhou, Min Lou
Expression levels of circulating miRNAs as biomarkers during multimodal treatment of rectal cancer - TiMiSNAR-mirna: a substudy of the TiMiSNAR Trial (NCT03962088)
Igor Monsellato, Elisabetta Garibaldi, Elisa Cassinotti, Ludovica Baldari, Luigi Boni, Ugo Elmore, Roberto Delpini, Riccardo Rosati, Roberto Perinotti, Filippo Alongi, Elisa Bertocchi, Stefania Gori, Giacomo Ruffo, Graziano Pernazza, Fabio Pulighe, Carlo De Nisco, Emilio Morpurgo, Tania Contardo, Enzo Mammano, Federico Perna, Benedetta Menegatti, Andrea Coratti, Piero Buccianti, Riccardo Balestri, Cristina Ceccarelli, Davide Cavaliere, Leonardo Solaini, Giorgio Ercolani, Elena Traverso, Vittorio Fusco, Valter Torri, Sara Orecchia
Efficacy of acupuncture for treatment of intermittent claudication in patients with degenerative lumbar spinal stenosis: protocol for a randomized controlled trial
Jing Zhou, Sixing Liu, Yuanjie Sun, Weiming Wang, Zhishun Liu
Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study
Neema Toto, Elaine Douglas, Markus Gmeiner, Lynn K. Barrett, Robert Lindblad, Lumbani Makhaza, Wilfred Nedi, Jacob Phulusa, Gerald V. Quinnan, Leigh A. Sawyer, Herbert Thole, Wesley C. Van Voorhis, Pui-Ying Iroh Tam
Accuracy of time to treatment estimates in the CRASH-3 clinical trial: impact on the trial results
Raoul Mansukhani, Lauren Frimley, Haleema Shakur-Still, Linda Sharples, Ian Roberts
Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial
Carlos Bernal-Utrera, Juan Jose Gonzalez-Gerez, Ernesto Anarte-Lazo, Cleofas Rodriguez-Blanco
Intermittent theta burst stimulation (iTBS) combined with working memory training to improve cognitive function in schizophrenia: study protocol for a randomized controlled trial
Jiaqi Song, Dan Liu, Meng Zhang, Huiqiu Wang, Shuping Tan
Sanfu herbal patch applied at acupoints in patients with bronchial asthma: study protocol for a randomized controlled trial
Xiaoyan Xie, Danghan Xu, Lixing Zhuang, Hui Liu, Sui Tan, Yanqing Lu, Meiyi Su, Jie Chen, Haihua Pan, Lu Lu, Yiming Xu, Muxi Liao, Zhanqiong Xu, Jun He
Efficacy of high-dose versus low-dose vitamin D supplementation on serum levels of inflammatory factors and mortality rate in severe traumatic brain injury patients: study protocol for a randomized placebo-controlled trial
Seyed Mostafa Arabi, Alireza Sedaghat, Mohammad Reza Ehsaei, Mohammad Safarian, Golnaz Ranjbar, Hamid Rezaee, Reza Rezvani, Hamed Tabesh, Abdolreza Norouzy
Research on allergic rhinitis improvement in asthmatic children after dust mite exposure reduction: a randomized, double-blind, cross-placebo study protocol
Ming Chen, YuFen Wu, Shuhua Yuan, Jiande Chen, Luanluan Li, Jinhong Wu, Jing Zhang, Yong Yin
RECOVERY- Respiratory Support: Respiratory Strategies for patients with suspected or proven COVID-19 respiratory failure; Continuous Positive Airway Pressure, High-flow Nasal Oxygen, and standard care: A structured summary of a study protocol for a randomised controlled trial
Gavin D. Perkins, Keith Couper, Bronwen Connolly, J. Kenneth Baillie, Judy M. Bradley, Paul Dark, Anthony De Soyza, Ellen Gorman, Alasdair Gray, Louisa Hamilton, Nicholas Hart, Chen Ji, Ranjit Lall, Nicola McGowan, Scott Regan, Anita K. Simonds, Emma Skilton, Nigel Stallard, Emily Stimpson, Joyce Yeung, Daniel F. McAuley
Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial
Berta Grau-Pujol, Daniel Camprubí, Helena Marti-Soler, Marc Fernández-Pardos, Caterina Guinovart, Jose Muñoz
PROTECT Trial: A cluster-randomized study with hydroxychloroquine versus observational support for prevention or early-phase treatment of Coronavirus disease (COVID-19): A structured summary of a study protocol for a randomized controlled trial
Oriana Nanni, Pierluigi Viale, Bernadette Vertogen, Claudia Lilli, Chiara Zingaretti, Caterina Donati, Carla Masini, Manuela Monti, Patrizia Serra, Roberto Vespignani, Veruska Grossi, Annibale Biggeri, Emanuela Scarpi, Francesca Galardi, Lucia Bertoni, Americo Colamartini, Fabio Falcini, Mattia Altini, Ilaria Massa, Raffaella Gaggeri, Giovanni Martinelli
muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial
Ing Ni Lu, Spoorthy Kulkarni, Marie Fisk, Michalis Kostapanos, Edward Banham-Hall, Sonakshi Kadyan, Simon Bond, Sam Norton, Andrew Cope, James Galloway, Frances Hall, David Jayne, Ian B. Wilkinson, Joseph Cheriyan
ACCORD: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients: A structured summary of a study protocol for a randomised controlled trial
Tom Wilkinson, Rupert Dixon, Clive Page, Miles Carroll, Gareth Griffiths, Ling-Pei Ho, Anthony De Soyza, Timothy Felton, Keir E. Lewis, Karen Phekoo, James D. Chalmers, Anthony Gordon, Lorcan McGarvey, Jillian Doherty, Robert C. Read, Manu Shankar-Hari, Nuria Martinez-Alier, Michael O’Kelly, Graeme Duncan, Roelize Walles, James Sykes, Charlotte Summers, Dave Singh
Brief motivational therapy versus enhanced usual care for alcohol use disorders in primary care in Chile: study protocol for an exploratory randomized trial
Nicolas A. Barticevic, Fernando Poblete, Soledad M. Zuzulich, Victoria Rodriguez, Laura Bradshaw
The role of vaginal palpation in motor learning of the pelvic floor muscles for women with stress urinary incontinence: study protocol for a randomized controlled trial
Letícia de Azevedo Ferreira, Fátima Faní Fitz, Márcia Maria Gimenez, Mayanni Magda Pereira Matias, Maria Augusta Tezelli Bortolini, Rodrigo Aquino Castro
Developing a roadmap to improve trial delivery for under-served groups: results from a UK multi-stakeholder process
Miles D. Witham, Eleanor Anderson, Camille Carroll, Paul M. Dark, Kim Down, Alistair S. Hall, Joanna Knee, Rebecca H. Maier, Gail A. Mountain, Gary Nestor, Laurie Oliva, Sarah R. Prowse, Amanda Tortice, James Wason, Lynn Rochester
Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial
Giovanni Ostuzzi, Chiara Gastaldon, Angelo Barbato, Barbara D’Avanzo, Mauro Tettamanti, Igor Monti, Andrea Aguglia, Eugenio Aguglia, Maria Chiara Alessi, Mario Amore, Francesco Bartoli, Massimo Biondi, Paola Bortolaso, Camilla Callegari, Giuseppe Carrà, Rosangela Caruso, Simone Cavallotti, Cristina Crocamo, Armando D’Agostino, Pasquale De Fazio, Chiara Di Natale, Laura Giusti, Luigi Grassi, Giovanni Martinotti, Michela Nosé, Davide Papola, Marianna Purgato, Alessandro Rodolico, Rita Roncone, Lorenzo Tarsitani, Giulia Turrini, Elisa Zanini, Francesco Amaddeo, Mirella Ruggeri, Corrado Barbui
Comparison of conventional, burst and high-frequency spinal cord stimulation on pain relief in refractory failed back surgery syndrome patients: study protocol for a prospective randomized double-blinded cross-over trial (MULTIWAVE study)
Maxime Billot, Nicolas Naiditch, Claire Brandet, Bertille Lorgeoux, Sandrine Baron, Amine Ounajim, Manuel Roulaud, Aline Roy-Moreau, Géraldine de Montgazon, Elodie Charrier, Lorraine Misbert, Benjamin Maillard, Tanguy Vendeuvre, Philippe Rigoard
Who knew? The misleading specificity of “double-blind” and what to do about it
Thomas A. Lang, Donna F. Stroup
Does propolis affect the quality of life and complications in subjects with irritable bowel syndrome (diagnosed with Rome IV criteria)? A study protocol of the randomized, double-blinded, placebo-controlled clinical trial
Mahsa Miryan, Pezhman Alavinejad, Mohammadreza Abbaspour, Davood Soleimani, Alireza Ostadrahimi
A phase II, single-center, double-blind, randomized placebo-controlled trial to explore the efficacy and safety of intravenous melatonin in patients with COVID-19 admitted to the intensive care unit (MelCOVID study): a structured summary of a study protocol for a randomized controlled trial
Miguel Rodríguez-Rubio, Juan Carlos Figueira, Darío Acuña-Castroviejo, Alberto M. Borobia, Germaine Escames, Pedro de la Oliva
Correction to: A nurse-led health coaching intervention for stroke survivors and their family caregivers in hospital to home transition care in Chongqing, China: a study protocol for a randomized controlled trial
Shuanglan Lin, Lily Dongxia Xiao, Diane Chamberlain
Fire needle plus cupping for acute herpes zoster: study protocol for a randomized controlled trial
Ying Zhang, Zuohui Liang, Shihua Li, Ling Yang, Taipin Guo, Yan Xu, Juanjuan Yang, Qiannan Xu, Qing Zhang, Jian Zhao, Cailian Li, Xiuhong Liu
Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial
Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif, Khalid Saeed Khan
Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial
Abdulrahman E. Koshak, Emad A. Koshak, Abdullah F. Mobeireek, Mazen A. Badawi, Siraj O. Wali, Husam M. Malibary, Ali F. Atwah, Meshari M. Alhamdan, Reem A. Almalki, Tariq A. Madani
Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic (Sleep COVID-19): structured summary of a study protocol for a randomised controlled trial
Greg J. Elder, Pamela Alfonso-Miller, William C. M. Atkinson, Nayantara Santhi, Jason G. Ellis
Using electroacupuncture to recover muscle strength in patients with knee osteoarthritis after total knee arthroplasty: a study protocol for a double-blinded, randomized, and placebo-controlled trial
Hui Xu, Bingxin Kang, Yulin Li, Jun Xie, Songtao Sun, Sheng Zhong, Chenxin Gao, Xirui Xu, Chi Zhao, Guowei Qiu, Lianbo Xiao
Recruitment and retention of mothers of preschoolers and school-aged children in a social media-delivered healthy eating intervention: lessons learned from a randomized controlled trial
Audrée-Anne Dumas, Simone Lemieux, Annie Lapointe, Véronique Provencher, Julie Robitaille, Sophie Desroches
Correction to: Investigating the non-specific effects of BCG vaccination on the innate immune system in Ugandan neonates: study protocol for a randomised controlled trial
Sarah Prentice, Emily L. Webb, Hazel M. Dockrell, Pontiano Kaleebu, Alison M. Elliott, Stephen Cose
Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multi-center, double-blind, randomized controlled trial in China
Xiaoke Li, Ludan Zhang, Mei Qiu, Yi Huang, Huanming Xiao, Bingjiu Lu, Yuyong Jiang, Fuli Long, Hui Lin, Jinyu He, Qikai Wu, Mingxiang Zhang, Li Wang, Xiaoning Zhu, Man Gong, Xuehua Sun, Jianguang Sun, Fengxia Sun, Wei Lu, Weihua Xu, Guang Chen, Zhiguo Li, Danan Gan, Xianzhao Yang, Hongbo Du, Yong’an Ye
Effects of “Thursdays at the Museum” at the Montreal Museum of Fine Arts on the mental and physical health of older community dwellers: the art-health randomized clinical trial protocol
Olivier Beauchet, Liam Cooper-Brown, Yoko Hayashi, Kevin Galery, Christine Vilcocq, Thomas Bastien
Resident-to-resident elder mistreatment (R-REM) intervention for direct care staff in assisted living residences: study protocol for a cluster randomized controlled trial
Jeanne A. Teresi, Stephanie Silver, Mildred Ramirez, Jian Kong, Joseph P. Eimicke, Gabriel D. Boratgis, Rhoda Meador, Leslie Schultz, Mark S. Lachs, Karl A. Pillemer
IMMPACT-recommended outcome measures and tools of assessment in burning mouth syndrome RCTs: an international Delphi survey protocol
B. Carey, A. M. Farag, C. Nasri-Heir, G. D. Klasser, A. Ariyawardana, M. Chmieliauskaite, A. Sardella, C. R. Carlson, C. S. Miller, L. Mejia, F. E. O’Neill, R. Albuquerque
Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials
Sheila Sprague, Taryn Scott, Shannon Dodds, David Pogorzelski, Paula McKay, Anthony D. Harris, Amber Wood, Lehana Thabane, Mohit Bhandari, Samir Mehta, Greg Gaski, Christina Boulton, Francesc Marcano-Fernández, Ernesto Guerra-Farfán, Joan Hebden, Lyndsay M. O’Hara, Gerard P. Slobogean
The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial
Alon Kalron, Anat Achiron, Massimiliano Pau, Eleonora Cocco
Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation
Dee Mangin, Larkin Lamarche, Doug Oliver, Sivan Bomze, Sayem Borhan, Tracy Browne, Tracey Carr, Julie Datta, Lisa Dolovich, Michelle Howard, Sarah Marentette-Brown, Cathy Risdon, Samina Talat, Jean-Eric Tarride, Lehana Thabane, Ruta Valaitis, David Price
Evaluation of Mental Health First Aid from the Perspective Of Workplace End UseRs—EMPOWER: protocol of cluster randomised trial phase
Opeyemi Atanda, Patrick Callaghan, Tim Carter, Graham Durcan, Nick O’Shea, Steve D. Brown, Paula Reavey, Eleni Vangeli, Sarah White, Kerry V. Wood
Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population
Kiley B. Vander Wyst, Micah L. Olson, Elva Hooker, Erica G. Soltero, Yolando P. Konopken, Colleen S. Keller, Felipe G. Castro, Allison N. Williams, Arlene D. R. Fernández, Donald L. Patrick, Stephanie L. Ayers, Houchun H. Hu, Armando Peña, Janiel Pimentel, William C. Knowler, Gabriel Q. Shaibi
Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial
Jesús Villar, José M. Añón, Carlos Ferrando, Gerardo Aguilar, Tomás Muñoz, José Ferreres, Alfonso Ambrós, César Aldecoa, Fernando Suárez-Sipmann, Kevin E. Thorpe, Peter Jüni, Arthur S. Slutsky, Carlos Ferrando, Ricard Mellado-Artigas, Javier Fernández, María Hernández, Manuel Castellá, Pedro Castro, Joan Ramón Badia, Gerardo Aguilar, José A. Carbonell, Rafael Badenes, Carlos Tornero, José Ferreres, María L. Blasco, Nieves Carbonell, Ainhoa Serrano, Mar Juan, José I. Gómez-Herreras, Mario Lorenzo López, Alfonso Ambrós, Carmen Martín, Rafael del Campo, Jaume Puig-Bernabeu, Carolina Ferrer, José de Andrés, Tomás Muñoz, Pablo Serna-Grande, Gonzalo Tamayo, Alberto Martínez-Ruíz, Iñaki Bilbao-Villasante, Jesús Villar, Rosa L. Fernández, César Pérez Calvo, Ánxela Vidal, José M. Añón, Juan Carlos Figueira, María José Asensio, Emilio Maseda, Fernando Suárez-Sipmann, Fernando Ramasco, Marina Varela-Durán, Pilar Díaz-Parada, Josep Trenado-Álvarez, María M. Fernández, César Aldecoa, Jesús Rico-Feijoo, Lorena Fernández, Jesús Sánchez-Ballesteros, Pablo Blanco-Schweizer, Domingo Martínez, Juan A. Soler, Arthur S. Slutsky, Peter Jüni, Kevin E. Thorpe, Rekha Thomas, Kosma Wysocki, Pamela de Verno, Gurpreet Lakhanpal, Clara Juando-Prats
A multi-centre open-label two-arm randomised superiority clinical trial of azithromycin versus usual care in ambulatory COVID-19: study protocol for the ATOMIC2 trial
Timothy S. C. Hinks, Vicki S. Barber, Joanna Black, Susan J. Dutton, Maisha Jabeen, James Melhorn, Najib M Rahman, Duncan Richards, Daniel Lasserson, Ian D. Pavord, Mona Bafadhel
Prednisone for patients with recurrent implantation failure: study protocol for a double-blind, multicenter, randomized, placebo-controlled trial
Yao Lu, Junhao Yan, Jiayin Liu, Jichun Tan, Yan Hong, Daimin Wei, Zi-jiang Chen, Yun Sun
The efficacy of ball blankets on insomnia in depression in outpatient clinics: study protocol for a randomized crossover multicentre trial
Sanne Toft Kristiansen, Poul Videbech, Merete Bender Bjerrum, Erik Roj Larsen
Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial
Babar Kayani, Sujith Konan, Jenni Tahmassebi, Atif Ayuob, Peter D. Moriarty, Fares S. Haddad
An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus streptomycin + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial
Rindra Vatosoa Randremanana, Mihaja Raberahona, Mamy Jean de Dieu Randria, Minoarisoa Rajerison, Voahangy Andrianaivoarimanana, Agathe Legrand, Tsinjo Fehizoro Rasoanaivo, Ravaka Randriamparany, Théodora Mayouya-Gamana, Reziky Mangahasimbola, Josie Bourner, Alex Salam, Annelies Gillesen, Tansy Edwards, Matthieu Schoenhals, Laurence Baril, Peter Horby, Piero Olliaro
Integrative medicine rehabilitation for children with cerebral palsy: a study protocol for a multicenter pragmatic randomized controlled trial
Mi-Joo Lee, Young-Ju Yun, Sun-ae Yu, Yong-Beom Shin, Soo-Yeon Kim, Jun-hee Han
Multi-centre, three arm, randomized controlled trial on the use of methylprednisolone and unfractionated heparin in critically ill ventilated patients with pneumonia from SARS-CoV-2 infection: A structured summary of a study protocol for a randomised controlled trial
Stefano Busani, Martina Tosi, Pasquale Mighali, Paola Vandelli, Roberto D’Amico, Marco Marietta, Francesco Forfori, Abele Donati, Gilda Cinnella, Amato De Monte, Daniela Pasero, Giacomo Bellani, Carlo Tascini, Giuseppe Foti, Marco Ranieri, Massimo Girardis
Periacetabular osteotomy with or without arthroscopic management in patients with hip dysplasia: study protocol for a multicenter randomized controlled trial
Geoffrey P. Wilkin, Stéphane Poitras, John Clohisy, Etienne Belzile, Ira Zaltz, George Grammatopoulos, Gerd Melkus, Kawan Rakhra, Tim Ramsay, Kednapa Thavorn, Paul E. Beaulé
Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial
Stefan J. Schaller, Kristina Fuest, Bernhard Ulm, Sebastian Schmid, Catherina Bubb, Rüdiger von Eisenhart-Rothe, Helmut Friess, Chlodwig Kirchhoff, Thomas Stadlbauer, Peter Luppa, Manfred Blobner, Bettina Jungwirth
Effect of albumin administration on outcomes in hypoalbuminemic patients hospitalized with community-acquired pneumonia (ALBUCAP): a prospective, randomized, phase III clinical controlled trial—a trial protocol
Alexander Rombauts, Gabriela Abelenda-Alonso, Antonella Francesca Simonetti, Guillermo Verdejo, Yolanda Meije, Lucia Ortega, Mercedes Clemente, Jordi Niubó, Yolanda Ruiz, Carlota Gudiol, Cristian Tebé, Sebastian Videla, Jordi Carratalà
The effect of on-site CT-derived fractional flow reserve on the management of decision making for patients with stable chest pain (TARGET trial): objective, rationale, and design
Junjie Yang, Dongkai Shan, Mei Dong, Zhiqiang Wang, Xiang Ma, Xinyang Hu, Hesong Zeng, Yundai Chen
The effect of ear acupressure (auriculotherapy) on sexual function of lactating women: protocol of a randomized sham controlled trial
Sanaz Barghamadi, Zainab Alimoardi, Terry Oleson, Nasim Bahrami
TOB-STOP-COP (TOBacco STOP in COPd trial): study protocol—a randomized open-label, superiority, multicenter, two-arm intervention study of the effect of “high-intensity” vs. “low-intensity” smoking cessation intervention in active smokers with chronic obstructive pulmonary disease
Mohamad Isam Saeed, Pradeesh Sivapalan, Josefin Eklöf, Charlotte Suppli Ulrik, Charlotta Pisinger, Therese Lapperre, Philip Tønnesen, Nils Hoyer, Julie Janner, Marie Lavesen Karlsson, Charlotte Sandau Bech, Kristoffer Marså, Nina Godtfredsen, Eva Brøndum, Birgit Munk, Merete Raaschou, Andrea Browatzski, Pernille Lütken, Jens-Ulrik Stæhr Jensen
Prediction of RECRUITment In randomized clinical Trials (RECRUIT-IT)—rationale and design for an international collaborative study
Benjamin Kasenda, Junhao Liu, Yu Jiang, Byron Gajewski, Cen Wu, Erik von Elm, Stefan Schandelmaier, Giusi Moffa, Sven Trelle, Andreas Michael Schmitt, Amanda K. Herbrand, Viktoria Gloy, Benjamin Speich, Sally Hopewell, Lars G. Hemkens, Constantin Sluka, Kris McGill, Maureen Meade, Deborah Cook, Francois Lamontagne, Jean-Marc Tréluyer, Anna-Bettina Haidich, John P. A. Ioannidis, Shaun Treweek, Matthias Briel
Development of a Core outcome set for fetal Myelomeningocele (COSMiC): study protocol
Samar Altoukhi, Clare L. Whitehead, Greg Ryan, Jan Deprest, Luc Joyeux, Katie Gallagher, James Drake, Paige Church, Daphne Horn, Yenge Diambomba, Jose C. A. Carvalho, Tim Van Mieghem
Correction to: Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection: A structured summary of a study protocol for a randomized controlled trial
Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif, Khalid Saeed Khan
Corticosteroid therapy for critically ill patients with COVID-19: A structured summary of a study protocol for a prospective meta-analysis of randomized trials
Jonathan A. C. Sterne, Janet Diaz, Jesús Villar, Srinivas Murthy, Arthur S. Slutsky, Anders Perner, Peter Jüni, Derek C. Angus, Djillali Annane, Luciano Cesar Pontes Azevedo, Bin Du, Pierre-Francois Dequin, Anthony C. Gordon, Cameron Green, Julian P. T. Higgins, Peter Horby, Martin J. Landray, Giuseppe Lapadula, Amelie Le Gouge, Marie Leclerc, Jelena Savović, Bruno Tomazini, Balasubramanian Venkatesh, Steve Webb, John C. Marshall
A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan
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, Stephen Freedman, Sarah Williamson-Urquhart, Terry Klassen, Tannis Erickson, Rick Watts, Pam Marples, Anna Heath, David Rios, Petros Pechlivanoglou, Chris McCabe, Gareth Hopkin, Amy Plint, Tremaine Rowe, Gary Joubert, Leslie Boisvert, Serge Gouin, Marie-Christine Auclair, Andrew Dixon, Manasi Rajagopal, Mithra Sivakumar, Darcy Beer, Jeannine Schellenberg
The effectiveness of a web-based decision aid for patients with hip osteoarthritis: study protocol for a randomized controlled trial
Lilisbeth Perestelo-Pérez, Yolanda Álvarez-Pérez, Amado Rivero-Santana, Vanesa Ramos-García, Andrea Duarte-Díaz, Alezandra Torres-Castaño, Ana Toledo-Chávarri, Mario Herrera-Perez, José Luis País-Brito, José Carlos del Castillo, José Ramón Vázquez, Carola Orrego, Pedro Serrano-Aguilar
Impact of the Maternal and Child Health handbook in Angola for improving continuum of care and other maternal and child health indicators: study protocol for a cluster randomised controlled trial
Olukunmi Omobolanle Balogun, Caroline Kaori Tomo, Keiji Mochida, Masashi Mikami, Henda da Rosa Vasconcelos, Isilda Neves, Hisakazu Hiraoka, Hirotsugu Aiga, Rintaro Mori, Kenji Takehara
Impact of Shenfu injection on a composite of organ dysfunction development in critically ill patients with coronavirus disease 2019 (COVID-19): A structured summary of a study protocol for a randomized controlled trial
Zong-Yu Wang, Shou-Zhi Fu, Liang Xu, Shu-Sheng Li, Ke-Jian Qian, Xian-Di He, Guo-Chao Zhu, Liang-Hai Li, Jun Zhang, Wen-Fang Li, Bing-Yu Qin, Chen-Liang Zhou, Peng-Lin Ma
Efficacy and safety of fire needle therapy for blood stasis syndrome of plaque psoriasis: protocol for a randomized, single-blind, multicenter clinical trial
Liu Liu, Yi Lu, Xiao-ning Yan, Su-qing Yang, Li-ping Gong, Ling-e Li, Yi-ding Zhao, Qing-feng Yin, Rui-ping Wang, Yue-peng An, Gang Huang, Jin-fang Zhang, Xiao-ying Sun, Xin Li, Bin Li
Protein delivery in intermittent and continuous enteral nutrition with a protein-rich formula in critically ill patients—a protocol for the prospective randomized controlled proof-of-concept Protein Bolus Nutrition (Pro BoNo) study
Simona Reinhold, Desirée Yeginsoy, Alexa Hollinger, Atanas Todorov, Lionel Tintignac, Michael Sinnreich, Caroline Kiss, Caroline E. Gebhard, Balázs Kovács, Bianca Gysi, Lara Imwinkelried, Martin Siegemund
The ORVAC trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis: a statistical analysis plan
Mark A Jones, Todd Graves, Bianca Middleton, James Totterdell, Thomas L Snelling, Julie A Marsh
Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial
Veronika Markova, Rebecka Hansen, Lars Lykke Thomsen, Anja Pinborg, Torben Moos, Charlotte Holm
High dose dexamethasone treatment for Acute Respiratory Distress Syndrome secondary to COVID-19: a structured summary of a study protocol for a randomised controlled trial
Luis Patricio Maskin, Gabriel Leonardo Olarte, Fernando Palizas Jr, Agostina E. Velo, María Fernanda Lurbet, Ignacio Bonelli, Natalio D. Baredes, Pablo Oscar Rodríguez
“Protocol for a phase 2, randomized, double-blind, placebo-controlled, safety and efficacy study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction”: study protocol for a randomized controlled trial
Dirk von Lewinski, Joseph B. Selvanayagam, Richard A. Schatz, Bernd Jilma, Jacek Kubica, Thomas J. Povsic, Darrell Nix, Stephan Henauer, Markus Wallner
Delivery of a Mental Health First Aid training package and staff peer support service in secondary schools: a process evaluation of uptake and fidelity of the WISE intervention
Harriet Fisher, Sarah Harding, Sarah Bell, Lauren Copeland, Rhiannon Evans, Jillian Powell, Ricardo Araya, Rona Campbell, Tamsin Ford, David Gunnell, Simon Murphy, Judi Kidger
The effect of prostacyclin (Iloprost) infusion at a dose of 1 ng/kg/min for 72 hours compared to placebo in mechanically ventilated patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial
Pär Ingemar Johansson, Morten Bestle, Peter Søe-Jensen, Klaus Tjelle Kristiansen, Jakob Stensballe, Niels Erikstrup Clausen, Anders Perner
The effect of psychoeducational intervention, based on a self-regulation model on menstrual distress in adolescents: a protocol of a randomized controlled trial
Somayeh Asgari, Zainab Alimoardi, Mohammad Ali Soleimani, Kelly-Ann Allen, Nasim Bahrami
Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial
Madunil A. Niriella, Dileepa S. Ediriweera, Arjuna P. De Silva, Ranjan Premarathne, Priyantha Balasooriya, Kaluthanthri D. Duminda, Neelika G. Malavige, Kamani Wanigasuriya, Sarath Lekamwasam, Senanayake A. Kularathne, Sisira Siribaddana, Hithanadura J. de Silva, Saroj Jayasinghe
Rivaroxaban compared to no treatment in ER-negative stage I–III early breast cancer patients (the TIP Trial): study protocol for a phase II preoperative window-of-opportunity study design randomised controlled trial
John Castle, Emma Blower, Nigel J. Bundred, James R. Harvey, Jecko Thachil, Andrea Marshall, Karina Cox, Silvia Cicconi, Chris Holcombe, Carlos Palmieri, Cliona C. Kirwan
Efficacy of Hwangryunhaedok-tang (Huang-lian-jie-du-tang, Oren-gedoku-to) for patients with hyperlipidemia: a study protocol for a randomized, double-blind, placebo-controlled, parallel, investigator-initiated clinical trial
Boram Lee, Kyungsun Han, Hyo-Ju Park, Ae-Ran Kim, O-Jin Kwon, Changsop Yang, Chung-Sik Cho
Acupressure therapy and Liu Zi Jue Qigong for pulmonary function and quality of life in patients with severe novel coronavirus pneumonia (COVID-19): a study protocol for a randomized controlled trial
Shuaipan Zhang, Qingguang Zhu, Chao Zhan, Wei Cheng, Xiao Mingfang, Min Fang, Lei Fang
Reporting of key methodological and ethical aspects of cluster trials in hemodialysis require improvement: a systematic review
Ahmed A. Al-Jaishi, Kelly Carroll, Cory E. Goldstein, Stephanie N. Dixon, Amit X. Garg, Stuart G. Nicholls, Jeremy M. Grimshaw, Charles Weijer, Jamie Brehaut, Lehana Thabane, P. J. Devereaux, Monica Taljaard
Evaluation of the efficacy and safety of the use of acupuncture for the adjuvant treatment of patients with post-stroke cognitive impairment: protocol for a randomized controlled trial
Ruijia Liu, Xudong Yu, Jisheng Wang, Ye Liu, Bowen Liu, Xinwei Li, Yue Wang, Tianyu Cao, Hongwei Yuan
Hydroxychloroquine plus personal protective equipment versus standard personal protective equipment alone for the prevention of COVID-19 infections among frontline healthcare workers: the HydrOxychloroquine Prophylaxis Evaluation(HOPE) trial: A structured summary of a study protocol for a randomized controlled trial
Bharath Kumar Tirupakuzhi Vijayaraghavan, Vivekanand Jha, Dorrilyn Rajbhandari, Sheila Nainan Myatra, Oommen John, Arpita Ghosh, Abhinav Bassi, Sumaiya Arfin, Mallikarjuna Kunigari, Rohina Joshi, Lachlan Donaldson, Naomi Hammond, Balasubramanian Venkatesh, Bharath Kumar Tirupakuzhi Vijayaraghavan, Vivekanand Jha, Balasubramanian Venkatesh, Vivekanand Jha, Sheila Nainan Myatra, Dorrilyn Rajbhandari, Oommen John, Arpita Ghosh, Abhinav Bassi, Sumaiya Arfin, Mallikarjuna Kunigari, Rohina Joshi, Lachlan Donaldson, Naomi Hammond, Santosh Kumar Nag, Syed Haider Mehdi Husaini, Viny Kantro, Ashita Singh, Arpit Mathew
Efficacy, safety and cost-effectiveness of a web-based platform delivering the results of a biomarker-based predictive model of biotherapy response for rheumatoid arthritis patients: a protocol for a randomized multicenter single-blind active controlled clinical trial (PREDIRA)
Dalifer Freites-Núñez, Athan Baillet, Luis Rodriguez-Rodriguez, Minh Vu Chuong Nguyen, Isidoro Gonzalez, Jose Luis Pablos, Alejandro Balsa, Monica Vazquez, Philippe Gaudin, Benjamín Fernandez-Gutierrez
Nutritional support for lactating women with or without azithromycin for infants compared to breastfeeding counseling alone in improving the 6-month growth outcomes among infants of peri-urban slums in Karachi, Pakistan—the protocol for a multiarm assessor-blinded randomized controlled trial (Mumta LW trial)
Ameer Muhammad, Yasir Shafiq, Muhammad Imran Nisar, Benazir Baloch, Amna Tanweer Yazdani, Nida Yazdani, Fyezah Jehan
Feasibility and acceptability of a brief routine weight management intervention for postnatal women embedded within the national child immunisation programme in primary care: randomised controlled cluster feasibility trial
A. J. Daley, K. Jolly, H. Bensoussane, N. Ives, S. A. Jebb, S. Tearne, S. M. Greenfield, L. Yardley, P. Little, N. Tyldesley-Marshall, R. V. Pritchett, E. Frew, H. M. Parretti
The COVIRL002 Trial-Tocilizumab for management of severe, non-critical COVID-19 infection: A structured summary of a study protocol for a randomised controlled trial
Aoife Cotter, Deborah Wallace, Cormac McCarthy, Eoin Feeney, Lorraine O’Neill, John Stack, Geraldine McCarthy, Rabia Hussain, Elena Alvarez Barco, Peter Doran, Patrick Mallon
Non-steroidal or opioid analgesia use for children with musculoskeletal injuries (the No OUCH study): statistical analysis plan
Anna Heath, Maryna Yaskina, Gareth Hopkin, Terry P. Klassen, Christopher McCabe, Martin Offringa, Petros Pechlivanoglou, Juan David Rios, Naveen Poonai, Samina Ali, Dennis Cote, Garth Meckler, Mark Roback, Anupam Kharbanda, Eyal Cohen, Lise Nigrovic, Geert W. ‘t Jong, Samina Ali, Naveen Poonai, Manasi Rajagopal, Lawrence Richer, Jennifer Thull-Freedman, Patrick McGrath, Timothy A. D. Graham, Lisa Hartling, Serge Gouin, Antonia Stang, Scott Sawyer, Maala Bhatt, Marie Christine Auclair, Kelly Kim, Lise Bourrier, Lauren Dawson, Kamary Coriolano DaSilva, Christopher McCabe, Gareth Hopkin, Jeff Round, Andy Willan, Maryna Yaskina, Anna Heath, David Rios, Martin Offringa, Petros Pechlivanoglou, Eleanor Pullenayegum, Pamela Marples, Rick Watts, Terry Klassen, Tannis Erickson, Brendon Foot, Serena Hickes, Kurt Schreiner, Julie Leung, Amy Drendel
Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial
Qing Kong, Shuming Mo, Wenqian Wang, Zihui Tang, Ying Wei, Yijie Du, Baojun Liu, Lingwen Kong, Yubao Lv, Jingcheng Dong
Implementation of strength-based case management for opioid-dependent patients presenting in medical emergency departments: rationale and study design of a randomized trial
Amber Regis, Sarah E. Meyers-Ohki, Sarah E. Mennenga, Peter P. Greco, Richard Glisker, Rhonda Kolaric, Ryan P. McCormack, Richard C. Rapp, Michael P. Bogenschutz
Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial
Yuan He, Yong Zhang, Shuqiang Gao, Xiaoling Wang, Na He, Deshuang Zhang, Wenbin Dong, Christian Wieg, Xiaoping Lei
Protocol for the measurement of changes in knowledge and engagement in the stepped wedge cluster randomised trial for childhood obesity prevention in Australia: (Reflexive Evidence and Systems interventions to Prevent Obesity and Non-communicable Disease (RESPOND))
Jillian Whelan, Claudia Strugnell, Steven Allender, Ariella R. Korn, Andrew D. Brown, Liliana Orellana, Josh Hayward, Vicki Brown, Colin Bell, Marj Moodie, Anna Peeters, Melanie Nichols
Effect of chemoprevention by low-dose aspirin of new or recurrent colorectal adenomas in patients with Lynch syndrome (AAS-Lynch): study protocol for a multicenter, double-blind, placebo-controlled randomized controlled trial
Adil Soualy, David Deutsch, Mourad Benallaoua, Amal Ait-Omar, Florence Mary, Sabine Helfen, Marouane Boubaya, Vincent Levy, Robert Benamouzig, Robert Benamouzig, Florence Mary, Amal Aït Omar, Mourad Benallaoua, Sabine Helfen, Semaher Al-Khafaji, Noémie Demare, Géraldine Perkins, Pierre Laurent-Puig, Jean-Christophe Saurin, Naouele Raby, Laurence Venat-Bouvet, Corinne Penaud, Delphine Bonnet, Virginie Sicart, Chloé Pomes, Thierry Lecomte, Claire Jollivet, Morgane Caulet, Stanislas Chaussade, Marion Dhooge, Fanny Maksimovic, Philippe Grandval, Sylvie Olschwang, Maud Saussereau, Jérôme Bellanger, Anne Netter-Coti, Hélène Delhomelle, Bruno Buecher, Lydia Mehdi, Sophie Lejeune, Afane Brahimi, Stéphane Cattan, Laurence Bellengier, David Tougeron, Sandrine Rafert, Emmanuelle Barouk Simonet, François Cornelis, Anna Serova-Erard, David Malka, Paul Gesta, Jeanne Oddoz, Véronique Mari, Samuel Lesourd, Gaëlle Kergoat, Louise Crivelli, Iradj Sobhani, Aurélien Amiot, Côme Lepage, Laurence Faivre-Olivier, Jean-Louis Jouve, Antoine Drouillard, Nora Perot, Marc Bardou, Sophie Nambot, Nadia Mekahli, Alain Lortholary, Carole Lenne, Jean-Paul Lagasse, Brahim Ouahrani, Thierry Frebourg, Nathalie Parodi, Maud Branchaud, Françoise Desseigne, Elodie Grinand, Olivier Ingster, Benoit Semelin, Francine Fein, Nelson Lourenco, Thomas Aparicio, Mathilde Brasseur, Anthony Lopez
How to deal with a temporary suspension and restarting your trial: our experiences and lessons learnt
Lynda Constable, Tracey Davidson, Suzanne Breeman, Seonaidh Cotton, Alison McDonald, Samantha Wileman, John Norrie
Potential Role of Acacia Senegal (Gum Arabic) as Immunomodulatory Agent among newly diagnosed COVID 19 Patients: A structured summary of a protocol for a randomised, controlled, clinical trial
Lamis Kaddam, Rasha Babiker, Sara Ali, Shahinaz Satti, Nour Ali, Maha Elamin, Mowaia Mukhtar, Mustafa Elnimeiri, Amal Saeed
Progressive exercise compared with best practice advice, with or without corticosteroid injection, for the treatment of rotator cuff disorders: statistical analysis plan for the Getting it Right: Addressing Shoulder Pain (GRASP) 2 × 2 factorial multicentre randomised controlled trial
Ioana R. Marian, Sally Hopewell, David J. Keene, Lucy Cureton, Sarah E. Lamb, Susan J. Dutton
Acupuncture treatment for carotid atherosclerotic plaques: study protocol for a pilot randomized, single blinded, controlled clinical trial
Junhe Zhou, Lin Zhao, Lingcui Meng, Huitao Liang, Ting Zhou, Siting Ye, Zhiqi Qi, Xichang Huang, Peng Zhou, Wenbin Fu
Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial
Nadir Kharma, Stefan Roehrig, Ahmed Atef Shible, Moustafa Sayed Elshafei, Dema Osman, Ingi Mohamed Elsaid, Salma Faisal Mustafa, Asjad Aldabi, Osamah A.M. Smain, Marcus D. Lance
Enoxaparin for primary thromboprophylaxis in ambulatory patients with coronavirus disease-2019 (the OVID study): a structured summary of a study protocol for a randomized controlled trial
Stefano Barco, Roland Bingisser, Giuseppe Colucci, André Frenk, Bernhard Gerber, Ulrike Held, Francois Mach, Lucia Mazzolai, Marc Righini, Thomas Rosemann, Tim Sebastian, Rebecca Spescha, Stefan Stortecky, Stephan Windecker, Nils Kucher
A three-arm, multicenter, open-label randomized controlled trial of hydroxychloroquine and low-dose prednisone to treat recurrent pregnancy loss in women with undifferentiated connective tissue diseases: protocol for the Immunosuppressant regimens for LIving FEtuses (ILIFE) trial
Shaoying Yang, Ruoning Ni, Yikang Lu, Suli Wang, Feng Xie, Chunyan Zhang, Liangjing Lu
Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial
Rosario Garcia-Vicuña, Francisco Abad-Santos, Isidoro González-Alvaro, Francisco Ramos-Lima, Jesús Sanz Sanz
Developing consensus on core outcome domains and measurement instruments for assessing effectiveness in perioperative pain management after sternotomy, breast cancer surgery, total knee arthroplasty, and surgery related to endometriosis
Ulrike Kaiser, Hiltrud Liedgens, Winfried Meissner, Claudia Weinmann, Peter Zahn, Esther Pogatzki-Zahn
Using qualitative research to explore intervention mechanisms: findings from the trial of the Learning Together whole-school health intervention
Emily Warren, G. J. Melendez-Torres, Russell Viner, Chris Bonell
Effect of acupuncture on women with poor ovarian response: a study protocol for a multicenter randomized controlled trial
Huanfang Xu, Chensi Zheng, Liyun He, Tongsheng Su, Huidan Wang, Yu Li, Cui Zhao, Cuilian Zhang, Yang Bai, Guoqing Tong, Li Chen, Fang Zhao, Huisheng Yang, Mingzhao Hao, Yaqian Yin, Li Yang, Yigong Fang, Baoyan Liu
Computerised tomography-based planning with conventional total hip arthroplasty versus robotic-arm assisted total hip arthroplasty: study protocol for a prospective randomised controlled trial
Babar Kayani, Sujith Konan, Jenni Tahmassebi, Atif Ayuob, Fares S. Haddad
A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol
Pablo Rodríguez-Sánchez-Laulhé, Luis Gabriel Luque-Romero, Jesús Blanquero, Alejandro Suero-Pineda, Ángela Biscarri-Carbonero, Francisco José Barrero-García, Alberto Marcos Heredia-Rizo
Correction to: Intra-cluster correlation coefficients in primary care patients with type 2 diabetes and hypertension
Yi Lin Lee, Yvonne Mei Fong Lim, Kian Boon Law, Sheamini Sivasampu
Ibudilast for alcohol use disorder: study protocol for a phase II randomized clinical trial
Elizabeth M. Burnette, Wave-Ananda Baskerville, Erica N. Grodin, Lara A. Ray
High-dose N-acetylcysteine for long-term, regular treatment of early-stage chronic obstructive pulmonary disease (GOLD I–II): study protocol for a multicenter, double-blinded, parallel-group, randomized controlled trial in China
Heshen Tian, Yumin Zhou, Longhui Tang, Fan Wu, Zhishan Deng, Bijia Lin, Peiyu Huang, Shaodan Wei, Dongxing Zhao, Jingping Zheng, Nanshan Zhong, Pixin Ran
Flow controlled ventilation in Acute Respiratory Distress Syndrome associated with COVID-19: A structured summary of a study protocol for a randomised controlled trial
Stefan Roehrig, Ali Ait Hssain, Nabil Al Hamid Shallik, Ingi Mohamed A. Elsaid, Salma Faisal Mustafa, Osama A. M. Smain, Ashraf Abdulla Molokhia, Marcus D. Lance
VeSpAR trial: a randomized controlled trial comparing vessel-sparing anastomotic repair and transecting anastomotic repair in isolated short bulbar urethral strictures
Wesley Verla, Marjan Waterloos, Mieke Waterschoot, Benjamin Van Parys, Anne-Françoise Spinoit, Nicolaas Lumen
Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multicentre, parallel group, double-blind, randomised, placebo-controlled clinical trial (MISTRAL)
Kathrin Wode, Johanna Hök Nordberg, Gunver S. Kienle, Nils O. Elander, Britt-Marie Bernhardson, Berit Sunde, Lena Sharp, Roger Henriksson, Per Fransson
It is unprecedented: trial management during the COVID-19 pandemic and beyond
Eleanor J. Mitchell, Khaled Ahmed, Suzanne Breeman, Seonaidh Cotton, Lynda Constable, Gillian Ferry, Kirsteen Goodman, Helen Hickey, Garry Meakin, Katy Mironov, Niamh Quann, Natalie Wakefield, Alison McDonald
A quadruple blind, randomised controlled trial of gargling agents in reducing intraoral viral load among hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial
Farhan Raza Khan, Syed Murtaza Raza Kazmi, Najeeha Talat Iqbal, Junaid Iqbal, Syed Tariq Ali, Syed Akbar Abbas
An online-based intervention to promote healthy eating through self-regulation among children: study protocol for a randomized controlled trial
Paula Magalhães, Cátia Silva, Beatriz Pereira, Gabriela Figueiredo, Ana Guimarães, Armanda Pereira, Pedro Rosário
A comparison of hydrophobic polyurethane and polyurethane peripherally inserted central catheter: results from a feasibility randomized controlled trial
Nicole C. Gavin, Tricia M. Kleidon, Emily Larsen, Catherine O’Brien, Amanda Ullman, Sarah Northfield, Gabor Mihala, Naomi Runnegar, Nicole Marsh, Claire M. Rickard
Efficacy and safety of electro-acupuncture (EA) on insomnia in patients with lung cancer: study protocol of a randomized controlled trial
Hongyu Yue, Shuang Zhou, Huangan Wu, Xuan Yin, Shanshan Li, Tingting Liang, Yan Li, Zhihong Fang, Xufeng Zhang, Linglin Wang, Min Han, Xiaolei Chen, Ming Zhang, Wei Zhang, Zhangjin Zhang, Shifen Xu
Meaningful Activities and Recovery (MA&R): the effect of a novel rehabilitation intervention among persons with psychiatric disabilities on activity engagement—study protocol for a randomized controlled trial
Siv Therese Bogevik Bjørkedal, Ulrika Bejerholm, Lene Falgaard Eplov, Tom Møller
Effects of Licorice on clinical symptoms and laboratory signs in moderately ill patients with pneumonia from COVID-19: A structured summary of a study protocol for a randomized controlled trial
Omid Safa, Mehdi Hassani-Azad, Mehdi Farashahinejad, Parivash Davoodian, Habib Dadvand, Soheil Hassanipour, Mohammad Fathalipour
The effect of graded activity and pain education (GAPE): an early post-surgical rehabilitation programme after lumbar spinal fusion—study protocol for a randomized controlled trial
Heidi Tegner, Bente Appel Esbensen, Marius Henriksen, Rachid Bech-Azeddine, Mari Lundberg, Louise Nielsen, Nanna Rolving
Effects of yoga, aerobic, and stretching and toning exercises on cognition in adult cancer survivors: protocol of the STAY Fit pilot randomized controlled trial
Neha P. Gothe, Emily D. Erlenbach, Samuel L. Streeter, Linda Lehovec
Long-term physical activity on prescription intervention for patients with insufficient physical activity level—a randomized controlled trial
Stefan Lundqvist, Mats Börjesson, Åsa Cider, Lars Hagberg, Camilla Bylin Ottehall, Johan Sjöström, Maria E. H. Larsson
Sarilumab versus standard of care for the early treatment of COVID-19 pneumonia in hospitalized patients: SARTRE: a structured summary of a study protocol for a randomised controlled trial
Antonio F. Caballero Bermejo, Belén Ruiz-Antorán, Ana Fernández Cruz, Elena Diago Sempere, Alejandro Callejas Díaz, Elena Múñez Rubio, Cristina Avendaño-Solá, Antonio Ramos Martínez, Aránzazu Sancho López
Can low-dose methotrexate reduce effusion-synovitis and symptoms in patients with mid- to late-stage knee osteoarthritis? Study protocol for a randomised, double-blind, and placebo-controlled trial
Zhaohua Zhu, Qinghong Yu, Xiaomei Leng, Weiyu Han, Zhanguo Li, Cibo Huang, Jieruo Gu, Yi Zhao, Kang Wang, Tianwang Li, Yifang Mei, Jianhua Xu, Zhiyi Zhang, David Hunter, Flavia Cicuttini, Xiaofeng Zeng, Changhai Ding
Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence
Kim Donoghue, Abigail Rose, Simon Coulton, Rachel Coleman, Joanna Milward, Thomas Philips, Colin Drummond, Hilary Little
Assessment of the efficacy of a fatigue management therapy in schizophrenia: study protocol for a randomized, controlled multi-centered study (ENERGY)
Stéphane Raffard, Nicolas Rainteau, Sophie Bayard, Yasmine Laraki, Joanna Norton, Delphine Capdevielle
Patient and healthcare professional experiences of the Salford Lung Studies: qualitative insights for future effectiveness trials
Kim Gemzoe, Rebecca Crawford, Ann Caress, Sheila McCorkindale, Rebecca Conroy, Susan Collier, Lynda Doward, Renu M. Vekaria, Sally Worsley, David A. Leather, Elaine Irving
Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial in Denmark
Anne Marie Rosendahl Madsen, Frederik Schaltz-Buchholzer, Thomas Benfield, Morten Bjerregaard-Andersen, Lars Skov Dalgaard, Christine Dam, Sisse Bolm Ditlev, Gulia Faizi, Isik Somuncu Johansen, Poul-Erik Kofoed, Gitte Schultz Kristensen, Ellen Christine Leth Loekkegaard, Christian Backer Mogensen, Libin Mohamed, Anne Ostenfeld, Emilie Sundhaugen Oedegaard, Marcus Kjaer Soerensen, Christian Wejse, Aksel Karl Georg Jensen, Sebastian Nielsen, Tyra Grove Krause, Mihai G. Netea, Peter Aaby, Christine Stabell Benn
Comparison of patient-led, fibromyalgia-orientated physical activity and a non-specific, standardised 6-month physical activity program on quality of life in individuals with fibromyalgia: a protocol for a randomised controlled trial
T. Rulleau, L. Planche, F. Etcheverrigaray, A. Dorion, N. Kacki, M. Miot, A. Liaigre, Y. Ganem, A. Schmidt, F. Taddéi, S. Acapo, J. Nizard, Y. M. Pluchon
Does immediate smart feedback on therapy adherence and inhalation technique improve asthma control in children with uncontrolled asthma? A study protocol of the IMAGINE I study
Esther T. Sportel, Martijn J. Oude Wolcherink, Job van der Palen, Anke Lenferink, Boony J. Thio, Kris L. L. Movig, Marjolein G. J. Brusse-Keizer
Overlap between adverse events (AEs) and serious adverse events (SAEs): a case study of a phase III cancer clinical trial
Elizabeth C. James, David Dunn, Adrian D. Cook, Andrew R. Clamp, Matthew R. Sydes
The effect of physiotherapy including frequent changes of body position and stimulation to physical activity for infants hospitalised with acute airway infections. Study protocol for a randomised controlled trial
Sonja Andersson-Marforio, Annika Lundkvist Josenby, Eva Ekvall Hansson, Christine Hansen
A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial
Gladys E. Ibañez, Kristopher Fennie, Linda Larkey, Nan Hu, Angel B. Algarin, Chelsea Valdivia, Helen Lavretsky
Neuroplasticity induced by general anaesthesia: study protocol for a randomised cross-over clinical trial exploring the effects of sevoflurane and propofol on the brain – A 3-T magnetic resonance imaging study of healthy volunteers
Signe Sloth Madsen, Kirsten Møller, Karsten Skovgaard Olsen, Mark Bitsch Vestergaard, Ulrich Lindberg, Henrik Bo Wiberg Larsson, Johan Mårtensson, Mads U. Werner, Sofia Alexandra Gaspar Santos, Mohammad Sohail Asghar
Correction to: Using qualitative research to explore intervention mechanisms: findings from the trial of the learning together whole-school health intervention
Emily Warren, G. J. Melendez-Torres, Russell Viner, Chris Bonell
Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)
Deirdre A. Hurley, Isabelle Jeffares, Amanda M. Hall, Alison Keogh, Elaine Toomey, Danielle McArdle, Suzanne M. McDonough, Suzanne Guerin, Ricardo Segurado, James Matthews
Motivational nondirective resonance breathing versus transcutaneous vagus nerve stimulation in the treatment of fibromyalgia: study protocol for a randomized controlled trial
Charles Ethan Paccione, Lien My Diep, Audun Stubhaug, Henrik Børsting Jacobsen
Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial
Bálint Erőss, Zsolt Molnár, Zsolt Szakács, Noémi Zádori, Lajos Szakó, Szilárd Váncsa, Márk Félix Juhász, Klementina Ocskay, Nóra Vörhendi, Katalin Márta, Andrea Szentesi, Andrea Párniczky, Péter J. Hegyi, Szabolcs Kiss, Mária Földi, Fanni Dembrovszky, Anna Kanjo, Piroska Pázmány, András Varró, Árpád Csathó, Zsuzsanna Helyes, Zoltán Péterfi, László Czopf, István Kiss, Antal Zemplényi, Dóra Czapári, Eszter Hegyi, Dalma Dobszai, Emőke Miklós, Attila Márta, Dominika Tóth, Richard Farkas, Nelli Farkas, Béla Birkás, Erika Pintér, Gábor Pethő, Borbála Zsigmond, Andrea Sárközi, Anikó Nagy, Péter Hegyi
An efficacy and safety study of rivaroxaban for the prevention of deep vein thrombosis in patients with left iliac vein compression treated with stent implantation (PLICTS): study protocol for a prospective randomized controlled trial
Miaomiao Li, Libin Zhang, Kaijie Zhang, Yuefeng Zhu, Zhenyu Shi, Wan Zhang, Bin Gao, Lubin Li, Zhengdong Fang, Li Yin, Bing Chen, Zhenjie Liu
Randomised controlled trial of Compensatory Cognitive Training and a Computerised Cognitive Remediation programme
Frances Dark, Ellie Newman, Victoria Gore-Jones, Veronica De Monte, Marta I. Garrido, Ilvana Dzafic
Prophylactic prednisolone for the prevention of early and intermediate adverse effects of radioactive iodine therapy in patients with thyroid cancer: study protocol for a single-centre, phase II/III, randomized, double-blinded, placebo-controlled clinical trial
Umesh Jayarajah, Mahilal Wijekoon, Sanjeewa A. Seneviratne
Effect of medically lowering intraocular pressure in glaucoma suspects with high myopia (GSHM study): study protocol for a randomized controlled trial
Feng Bin Lin, Shi Da Chen, Yun He Song, Wei Wang, Ling Jin, Bing Qian Liu, Yu Hong Liu, Mei Ling Chen, Kai Gao, David S. Friedman, Jost B. Jonas, Tin Aung, Lin Lv, Yi Zhi Liu, Xiu Lan Zhang, Xiu Lan Zhang, Yi Zhi Liu, Lin Lv, David S. Friedman, Jost B. Jonas, Tin Aung, Shi Da Chen, Wei Wang, Feng Bin Lin, Yun He Song, Fei Li, Kai Gao, Bing Qian Liu, Yu Hong Liu, Mei Ling Chen, Neil M. Bressler, Ki Ho Park, Ming Guang He, Ching-yu Cheng, Paul Healey, Xiang Chen, Guang Xian Tang, Ling Jin
Cognitive-behavioral family therapy as psychoeducation for adolescents with high-functioning autism spectrum disorders: Aware and Care for my Autistic Traits (ACAT) program study protocol for a pragmatic multisite randomized controlled trial
Fumiyo Oshima, Mandy William, Noriko Takahashi, Aki Tsuchiyagaito, Hitoshi Kuwabara, Akihiro Shiina, Mikuko Seto, Minako Hongo, Yui Iwama, Yoshiyuki Hirano, Chihiro Sutoh, Kayoko Taguchi, Tokiko Yoshida, Yohei Kawasaki, Yoshihito Ozawa, Jiro Masuya, Noriyuki Sato, Shizuka Nakamura, Masaru Kuno, Jumpei Takahashi, Toshiyuki Ohtani, Daisuke Matsuzawa, Naoko Inada, Miho Kuroda, Mika Ando, Arinobu Hori, Akiko Nakagawa, Eiji Shimizu
Moving fast but going slow: coordination challenges for trials of COVID-19 post-exposure prophylaxis
Darrell H. S. Tan, Rupesh Agrawal, Ruanne V. Barnabas, Jon T. Giles, Peter Dull
Randomized controlled clinical trial evaluating the efficacy of hyperbaric oxygen therapy in facilitating the healing of chronic foot ulcers in diabetic patients: the study protocol
Jocefábia Reika Alves Lopes, Mariza D’Agostino Dias, João Antonio Correa, Maria Alice Bragagnolo Batalha, Luanda Karla Dantas Guerra
Comparison of endoscopic ultrasound-guided hepaticogastrostomy and the antegrade technique in the management of unresectable malignant biliary obstruction: study protocol for a prospective, multicentre, randomised controlled trial
Ye Liao, Marc Giovannini, Ning Zhong, Tingyue Xiao, Shiyun Sheng, Yufan Wu, Jingjing Zhang, Sheng Wang, Xiang Liu, Siyu Sun, Jintao Guo
Manual acupuncture versus sham acupuncture and usual care for the prevention of primary dysmenorrhea (PD): study protocol for a randomized controlled trial
Lingling Yu, Shiqin Liu, Cuihong Zheng, Wenhua Liu, Hua Wang, Fengxia Liang, Wei Lu, Shabei Xu, Wei Wang
Hypofractionated radiation therapy comparing a standard radiotherapy schedule (over 3 weeks) with a novel 1-week schedule in adjuvant breast cancer: an open-label randomized controlled study (HYPORT-Adjuvant)—study protocol for a multicentre, randomized phase III trial
Sanjoy Chatterjee, Santam Chakraborty, Santam Chakraborty, Selvamani Backianathan, Punita Lal, Subhash Gupta, Rosina Ahmed, Shagun Misra, Patricia Solomon, Rajesh Balakrishan, Debashree Guha, K. J. Maria Das, Anurupa Mahata, Samar Mandal, Abha Kumari, Henry Finlay Godson, Sandip Ganguly, Debdeep Dey, Sanjoy Chatterjee
Evaluation of the effect of Cooled HaEmodialysis on Cognitive function in patients suffering with end-stage KidnEy Disease (E-CHECKED): feasibility randomised control trial protocol
Indranil Dasgupta, Aghogho Odudu, Jyoti Baharani, Niall Fergusson, Helen Griffiths, John Harrison, Paul Maruff, G Neil Thomas, Gavin Woodhall, Samir Youseff, George Tadros
Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials
Sheila Sprague, Taryn Scott, Shannon Dodds, David Pogorzelski, Paula McKay, Anthony D. Harris, Amber Wood, Lehana Thabane, Mohit Bhandari, Samir Mehta, Greg Gaski, Christina Boulton, Francesc Marcano-Fernández, Ernesto Guerra-Farfán, Joan Hebden, Lyndsay M. O’Hara, Gerard P. Slobogean, Gerard P. Slobogean, Sheila Sprague, Jeffrey Wells, Mohit Bhandari, Jean-Claude D’Alleyrand, Anthony D. Harris, Daniel C. Mullins, Lehana Thabane, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas Marchand, Lyndsay M. O’Hara, Robert Zura, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, P. J. Devereaux, Gordon H. Guyatt, Diane Heels-Ansdell, Debra Marvel, Jana Palmer, Jeff Friedrich, Nathan N. O’Hara, Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O’Toole, Bradley A. Petrisor, Megan Camara, Franca Mossuto, Manjari G. Joshi, Justin Fowler, Jessica Rivera, Max Talbot, Shannon Dodds, Alisha Garibaldi, Silvia Li, Uyen Nguyen, David Pogorzelski, Alejandra Rojas, Taryn Scott, Gina Del Fabbro, Olivia Paige Szasz, Paula McKay, Andrea Howe, Joshua Rudnicki, Haley Demyanovich, Kelly Little, C. Daniel Mullins, Michelle Medeiros, Eric Kettering, Diamond Hale, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Theodore Manson, Jason Nascone, Ebrahim Paryavi, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Haley K. Demyanovich, Katherine Joseph, Brad A. Petrisor, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jordan Leonard, Francesc A. Marcano-Fernández, Jodi Gallant, Federico Persico, Marko Gjorgjievski, Annie George, Roman M. Natoli, Greg E. Gaski, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Joseph R. Baele, Brian H. Mullis, Lauren C. Hill, Andrea Hudgins, Patrick Osborn, Sarah Pierrie, Eric Martinez, Joseph Kimmel, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich Jr, David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill Jr, Michael J. Garitty, Andrew S. Poole, Michael L. Sims, Clark M. Walker, Robert M. Carlisle II, Erin Adams Hofer, Brandon S. Huggins, Michael D. Hunter, William A. Marshall, Shea Bielby Ray, Cory D. Smith, Kyle M. Altman, Julia C. Bedard, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Stephanie L. Tanner, Rebecca G. Snider, Christine E. Townsend, Kayla H. Pham, Abigail Martin, Emily Robertson, Theodore Miclau, Utku Kandemir, Meir Marmor, Amir Matityahu, R. Trigg McClellan, Eric Meinberg, David Shearer, Paul Toogood, Anthony Ding, Erin Donohue, Tigist Belaye, Eleni Berhaneselase, Alexandra Paul, Kartik Garg, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. “ Chip” Routt, Mayank Rao, Guillermo Pechero, Adam Miller, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Kalia Sadasivan, Chris Koenig, Daniel Bailey, Daniel Wentworth, Chi Van, Justin Schwartz, Niloofar Dehghan, Clifford B. Jones, J. Tracy Watson, Michael McKee, Ammar Karim, Michael Talerico, Debra L. Sietsema, Alyse Williams, Tayler Dykes, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Andres Rodriguez, Vamshi Gajari, Elsa Rodriguez, Charles Pritchett, Christina Boulton, Jason Lowe, Jason Wild, John T. Ruth, Michel Taylor, Andrea Seach, Sabina Saeed, Hunter Culbert, Alejandro Cruz, Thomas Knapp, Colin Hurkett, Maya Lowney, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Francesc Marcano-Fernández, Montsant Jornet-Gibert, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Guillem Graells-Alonso, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Ernesto Guerra-Farfán, Yaiza García, Nicholas M. Romeo, Heather A. Vallier, Mary A. Breslin, Joanne Fraifogl, Eleanor S. Wilson, Leanne K. Wadenpfuhl, Paul G. Halliday, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Mauri Zomar, Ella Spicer, Chen “Brenda” Fan, Kyrsten Payne, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Claire Bartel, Robert Miles Mayberry, Maggie Brownrigg, Cara Girardi, Ada Mayfield, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, Lolita Ramsey, James S. Ahn, Farhanaz Panjshiri, Sharmistha Das, Antoinisha D. English, Sharon M. Haaser, Jaslynn A. N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Debra Bullard, Wendy Williams, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Mark Russell, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Clifford A. Reilly, Peter DePalo, Amy E. Hall, Marilyn Heng, Mitchel B. Harris, R. Malcolm Smith, David W. Lhowe, John G. Esposito, Mira Bansal, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Heather K. Champion, Leslie N. Johnson, Sheketha L. McGee, Eldrin L. Bhanat, Samir Mehta, Derek Donegan, Jaimo Ahn, Annamarie Horan, Mary Dooley, Ashley Kuczinski, Ashley Iwu, David Potter, Robert VanDemark III, Branden Pfaff, Troy Hollinsworth, Michael J. Weaver, Arvind G. von Keudell, Michael F. McTague, Elizabeth M. Allen, Todd Jaeblon, Robert Beer, Mark J. Gage, Rachel M. Reilly, Cindy Sparrow
Application of two different nasal CPAP levels for the treatment of respiratory distress syndrome in preterm infants—“The OPTTIMMAL-Trial”—Optimizing PEEP To The IMMAture Lungs: study protocol of a randomized controlled trial
Markus Waitz, Corinna Engel, Rolf Schloesser, Ulrich Rochwalsky, Sascha Meyer, Alexander Larsen, Paul Hoffmann, Michael Zemlin, Bettina Bohnhorst, Corinna Peter, Marc Hoppenz, Thomas Pabst, Klaus-Peter Zimmer, Axel R. Franz, Christoph Haertel, Eric Frieauff, Julia Sandkötter, Katja Masjosthusmann, Philipp Deindl, Dominique Singer, Melanie Heidkamp, Annesuse Schmidt, Harald Ehrhardt
Ferritin measurement IN Donors—Effectiveness of iron Monitoring to diminish iron deficiency and low haemoglobin in whole blood donors (FIND’EM): study protocol for a stepped wedge cluster randomised trial
Maike G. Sweegers, Saurabh Zalpuri, Franke A. Quee, Elisabeth M. J. Huis in ‘t Veld, Femmeke J. Prinsze, Emiel O. Hoogendijk, Jos W. R. Twisk, Anton W. M. van Weert, Wim L. A. M. de Kort, Katja van den Hurk
Research transparency promotion by surgical journals publishing randomised controlled trials: a survey
N. Lombard, A. Gasmi, L. Sulpice, K. Boudjema, F. Naudet, D. Bergeat
Uptake of Task-Strengthening Strategy for Hypertension (TASSH) control within Community-Based Health Planning Services in Ghana: study protocol for a cluster randomized controlled trial
Kwaku Poku Asante, Juliet Iwelunmor, Kingsley Apusiga, Joyce Gyamfi, Solomon Nyame, Kezia Gladys Amaning Adjei, Angela Aifah, Kwame Adjei, Deborah Onakomaiya, William F. Chaplin, Gbenga Ogedegbe, Jacob Plange-Rhule
The MUK eight protocol: a randomised phase II trial of cyclophosphamide and dexamethasone in combination with ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and a proteasome inhibitor
Samantha Hinsley, Katrina Walker, Debbie Sherratt, Lucy Bailey, Sadie Reed, Louise Flanagan, Sophie McKee, Fiona Brudenell Straw, Bryony Dawkins, David Meads, Holger W. Auner, Martin F. Kaiser, Mark Cook, Sarah Brown, Gordon Cook
A multi-center, randomized controlled trial by the Integrative Management in Japan for Epidemic Disease (IMJEDI study-RCT) on the use of Kampo medicine, kakkonto with shosaikotokakikyosekko, in mild-to-moderate COVID-19 patients for symptomatic relief and prevention of severe stage: a structured summary of a study protocol for a randomized controlled trial
Shin Takayama, Takao Namiki, Takashi Ito, Ryutaro Arita, Hajime Nakae, Seiichi Kobayashi, Tetsuhiro Yoshino, Tomoaki Ishigami, Koichiro Tanaka, Mosaburo Kainuma, Kotaro Nochioka, Airi Takagi, Masaru Mimura, Takuhiro Yamaguchi, Tadashi Ishii
A Randomized Open label Phase-II Clinical Trial with or without Infusion of Plasma from Subjects after Convalescence of SARS-CoV-2 Infection in High-Risk Patients with Confirmed Severe SARS-CoV-2 Disease (RECOVER): A structured summary of a study protocol for a randomised controlled trial
Maike Janssen, Ulrike Schäkel, Carine Djuka Fokou, Johannes Krisam, Jacek Stermann, Katharina Kriegsmann, Isabella Haberbosch, Jan Philipp Novotny, Stefan Weber, Maria Vehreschild, Martin Bornhäuser, Lars Bullinger, Michael Schmitt, Tobias Liebregts, Peter Dreger, Hanns-Martin Lorenz, Anna Plaszczyca, Ralf Bartenschlager, Barbara Müller, Hans-Georg Kräusslich, Niels Halama, Dirk Jäger, Richard F. Schlenk, Albrecht Leo, Stefan Meuer, Markus A. Weigand, Johann Motsch, Uta Merle, Claudia M. Denkinger, Carsten Müller-Tidow
Correction to: Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial
Charlotte Hanlon, Atalay Alem, Girmay Medhin, Teshome Shibre, Dawit A. Ejigu, Hanna Negussie, Michael Dewey, Lawrence Wissow, Martin Prince, Ezra Susser, Crick Lund, Abebaw Fekadu
Early migration of stemless and stemmed humeral components after total shoulder arthroplasty for osteoarthritis—study protocol for a randomized controlled trial
Marc Randall Kristensen Nyring, Bo S. Olsen, Müjgan Yilmaz, Michael M. Petersen, Gunnar Flivik, Jeppe V. Rasmussen
Targeted hypothermia versus targeted normothermia after out-of-hospital cardiac arrest: a statistical analysis plan
Janus Christian Jakobsen, Josef Dankiewicz, Theis Lange, Tobias Cronberg, Gisela Lilja, Helena Levin, Jan Bělohlávek, Clifton Callaway, Alain Cariou, David Erlinge, Jan Hovdenes, Michael Joannidis, Per Nordberg, Mauro Oddo, Paolo Pelosi, Hans Kirkegaard, Glenn Eastwood, Christian Rylander, Manoj Saxena, Christian Storm, Fabio Silvio Taccone, Matthew P. Wise, Matt P. G. Morgan, Paul Young, Alistair Nichol, Hans Friberg, Susann Ullén, Niklas Nielsen
‘Mothers moving towards empowerment’ intervention to reduce stigma and improve treatment adherence in pregnant women living with HIV in Botswana: study protocol for a pragmatic clinical trial
Ohemaa B. Poku, Ari R. Ho-Foster, Patlo Entaile, Supriya Misra, Haitisha Mehta, Shathani Rampa, Melody Goodman, Tonya Arscott-Mills, Evan Eschliman, Valerie Jackson, Tadele Melese, Timothy D. Becker, Marlene Eisenberg, Bruce Link, Vivian Go, Philip Renison Opondo, Michael B. Blank, Lawrence H. Yang
Should the nail plate be replaced or discarded after nail bed repair in children? Nail bed INJury Analysis (NINJA) randomised controlled trial: a health economic and statistical analysis plan
Jamie R. Stokes, May Ee Png, Abhilash Jain, Aina V. H. Greig, Beverly A. Shirkey, Melina Dritsaki, Jonathan A. Cook
Spinal cord stimulation for chronic intractable trunk or limb pain: study protocol for a Chinese multicenter randomized withdrawal trial (CITRIP study)
Yang Lu, Peng Mao, Guihuai Wang, Wei Tao, Donglin Xiong, Ke Ma, Rongchun Li, Dan Feng, Wanru Duan, Shun Li, Zhijian Fu, Zhiying Feng, Yi Jin, Li Wan, Yan Lu, Daying Zhang, Bifa Fan, James Jin Wang, Luming Li
Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial
Ryan Bradley, Blake O. Langley, Jennifer J. Ryan, John Phipps, Douglas A. Hanes, Emily Stack, Janet K. Jansson, Thomas O. Metz, Jan Frederik Stevens
The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation
Carol Bugge, Rohna Kearney, Melanie Dembinsky, Aethele Khunda, Margaret Graham, Wael Agur, Suzanne Breeman, Lucy Dwyer, Andrew Elders, Mark Forrest, Kirsteen Goodman, Karen Guerrero, Christine Hemming, Helen Mason, Doreen McClurg, Lynn Melone, John Norrie, Ranee Thakar, Suzanne Hagen
Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial
Suzanne Hagen, Rohna Kearney, Kirsteen Goodman, Lynn Melone, Andrew Elders, Sarkis Manoukian, Wael Agur, Catherine Best, Suzanne Breeman, Melanie Dembinsky, Lucy Dwyer, Mark Forrest, Margaret Graham, Karen Guerrero, Christine Hemming, Aethele Khunda, Helen Mason, Doreen McClurg, John Norrie, Anastasia Karachalia-Sandri, Ranee Thakar, Carol Bugge
Effects of visualization of successful revascularization on chest pain and quality of life in chronic coronary syndrome: study protocol for the multi-center, randomized, controlled PLA-pCi-EBO-pilot-trial
Michael Wester, Franziska Koll, Florian Zeman, Astrid Dempfle, Michael Koller, Norbert Frey, Lars S. Maier, Samuel Sossalla
The TIRS trial: protocol for a cluster randomized controlled trial assessing the efficacy of preventive targeted indoor residual spraying to reduce Aedes-borne viral illnesses in Merida, Mexico
Pablo Manrique-Saide, Natalie E. Dean, M. Elizabeth Halloran, Ira M. Longini, Matthew H. Collins, Lance A. Waller, Hector Gomez-Dantes, Audrey Lenhart, Thomas J. Hladish, Azael Che-Mendoza, Oscar D. Kirstein, Yamila Romer, Fabian Correa-Morales, Jorge Palacio-Vargas, Rosa Mendez-Vales, Pilar Granja Pérez, Norma Pavia-Ruz, Guadalupe Ayora-Talavera, Gonzalo M. Vazquez-Prokopec
Correction to: Why do patients take part in research? An overview of systematic reviews of psychosocial barriers and facilitators
Rebecca Sheridan, Jacqueline Martin-Kerry, Joanna Hudson, Adwoa Parker, Peter Bower, Peter Knapp
Effects of Ginger on clinical manifestations and paraclinical features of patients with Severe Acute Respiratory Syndrome due to COVID-19: A structured summary of a study protocol for a randomized controlled trial
Omid Safa, Mehdi Hassaniazad, Mehdi Farashahinejad, Parivash Davoodian, Habib Dadvand, Soheil Hassanipour, Mohammad Fathalipour
Efficacy of one-stage cartilage repair using allogeneic mesenchymal stromal cells and autologous chondron transplantation (IMPACT) compared to nonsurgical treatment for focal articular cartilage lesions of the knee: study protocol for a crossover randomized controlled trial
J. V. Korpershoek, L. A. Vonk, E. C. Kester, L. B. Creemers, T. S. de Windt, M. M. A. Kip, D. B. F. Saris, R. J. H. Custers
Treating depression with a smartphone-delivered self-help cognitive behavioral therapy for insomnia: study protocol for a parallel group randomized controlled trial
Victoria Ka-Ying Hui, Christy Yim-Fan Wong, Eric Ka-Yiu Ma, Fiona Yan-Yee Ho, Christian S. Chan
The prophylactic and therapeutic effects of moxibustion combined with traditional Chinese medicine decoction for treating chemotherapy-induced myelosuppression in early-stage breast cancer: study protocol for a randomized controlled trial
Yajie Ji, Siyu Li, Xinyue Zhang, Yu Liu, Qing Lu, Qiong Li, Weili Chen, Jiayu Sheng, Ke Jiang, Hongli Liang, Shanyan Sha, Mengting Li, Zongxin Chen, Peiyi Zheng, Minhong Wang, Yuanyuan Feng, Lei Wang, Huangan Wu, Huirong Liu, Yan Huang, Zhiguang Yin, Xiaohong Xue
Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial
Thomas J. Stamm, Julia C. Zwick, Grace O’Malley, Lene-Marie Sondergeld, Martin Hautzinger
Home Treatment of Older People with Symptomatic SARS-CoV-2 Infection (COVID-19): A structured Summary of a Study Protocol for a Multi-Arm Multi-Stage (MAMS) Randomized Trial to Evaluate the Efficacy and Tolerability of Several Experimental Treatments to Reduce the Risk of Hospitalisation or Death in outpatients aged 65 years or older (COVERAGE trial)
Alexandre Duvignaud, Edouard Lhomme, Thierry Pistone, Racha Onaisi, Rémi Sitta, Valérie Journot, Duc Nguyen, Nathan Peiffer-Smadja, Antoine Crémer, Stéphane Bouchet, Thomas Darnaud, Delphine Poitrenaud, Lionel Piroth, Christine Binquet, Jean-François Michel, Benjamin Lefèvre, David Lebeaux, Josselin Lebel, Julie Dupouy, Caroline Roussillon, Anne Gimbert, Linda Wittkop, Rodolphe Thiébaut, Joanna Orne-Gliemann, Jean-Philippe Joseph, Laura Richert, Xavier Anglaret, Denis Malvy
An adaptive randomised placebo controlled phase II trial of antivirals for COVID-19 infection (VIRCO): A structured summary of a study protocol for a randomised controlled trial
James H. McMahon, Jillian S. Y. Lau, Janine Roney, Benjamin A. Rogers, Jason Trubiano, Joseph Sasadeusz, James S. Molton, Bradley Gardiner, Sue J. Lee, Jennifer F. Hoy, Allen Cheng, Anton Y. Peleg
The Efficacy of Famotidine in improvement of outcomes in Hospitalized COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial
Hamid Reza Samimagham, Mehdi Hassani Azad, Maryam Haddad, Mohsen Arabi, Dariush Hooshyar, Mitra KazemiJahromi
Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial
Lisa M. Wintner, Johannes M. Giesinger, Monika Sztankay, Andrew Bottomley, Bernhard Holzner
Effect of probiotics on nasal and intestinal microbiota in people with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study
Yongcan Wu, Caixia Pei, Xiaomin Wang, Mingjie Wang, Demei Huang, Fei Wang, Wei Xiao, Zhenxing Wang
Group intervention for siblings and parents of children with chronic disorders (SIBS-RCT): study protocol for a randomized controlled trial
Krister W. Fjermestad, Wendy K. Silverman, Torun M. Vatne
Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial
Chiara Busso, Gabriele Castorina, Marco Di Monaco, Daniel Rodriguez, Hadis Mahdavi, Simone Balocco, Marco Trucco, Marco Conti, Alessandro Castagna, Marco Alessandro Minetto
Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac – PROFISCOV: A structured summary of a study protocol for a randomised controlled trial
Ricardo Palacios, Elizabeth González Patiño, Roberta de Oliveira Piorelli, Monica Tilli Reis Pessoa Conde, Ana Paula Batista, Gang Zeng, Qianqian Xin, Esper G. Kallas, Jorge Flores, Christian F. Ockenhouse, Christopher Gast
Short-term fasting accompanying chemotherapy as a supportive therapy in gynecological cancer: protocol for a multicenter randomized controlled clinical trial
Daniela Koppold-Liebscher, Christian S. Kessler, Nico Steckhan, Vanessa Bähr, Cornelia Kempter, Manfred Wischnewsky, Marisa Hübner, Barbara Kunz, Marion Paul, Stefanie Zorn, Sophia Sari, Michael Jeitler, Rainer Stange, Andreas Michalsen
Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a study protocol for a phase II randomised controlled trial (the EMINENT trial)
Raymond Javan Chan, Jon Emery, Katharine Cuff, Laisa Teleni, Camilla Simonsen, Jane Turner, Monika Janda, Daniel Mckavanagh, Lee Jones, Emma McKinnell, Melissa Gosper, Juanita Ryan, Ria Joseph, Bethany Crowe, Jennifer Harvey, Marissa Ryan, Christine Carrington, Rebecca Nund, Megan Crichton, Steven McPhail
Does a video clip enhance recruitment into a parenting trial? Learnings from a study within a trial
Holly C. Mattock, Rachael Ryan, Christine O’Farrelly, Daphne Babalis, Paul G. Ramchandani
Equine-assisted biographical work (EABW) with individuals in the second half of life: study protocol of a multicentre randomised controlled trial
Julia Schmidt, Andrea Wartenberg-Demand, Simon Forstmeier
Tailored, psychological intervention for anxiety and/or depression in people with chronic obstructive pulmonary disease (COPD), TANDEM (Tailored intervention for ANxiety and DEpression Management in COPD): statistical analysis plan for a randomised controlled trial
Claire L. Chan, Melanie Smuk, Ratna Sohanpal, Hilary Pinnock, Stephanie J. C. Taylor
Engaging adolescents in changing behaviour (EACH-B): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity
Sofia Strömmer, Millie Barrett, Kathryn Woods-Townsend, Janis Baird, David Farrell, Joanne Lord, Leanne Morrison, Sarah Shaw, Christina Vogel, Wendy Lawrence, Donna Lovelock, Lisa Bagust, Judit Varkonyi-Sepp, Patsy Coakley, Lyall Campbell, Ross Anderson, Tina Horsfall, Neelam Kalita, Olu Onyimadu, John Clarke, Cyrus Cooper, Debbie Chase, Danielle Lambrick, Paul Little, Mark Hanson, Keith Godfrey, Hazel Inskip, Mary Barker
Improving adherence to an online intervention for low mood with a virtual coach: study protocol of a pilot randomized controlled trial
Simon Provoost, Annet Kleiboer, José Ornelas, Tibor Bosse, Jeroen Ruwaard, Artur Rocha, Pim Cuijpers, Heleen Riper
A blended eHealth intervention for insomnia following acquired brain injury: study protocol for a randomized controlled trial
Marthe E. Ford, Gert J. Geurtsen, Erny Groet, Coen A. M. Van Bennekom, Eus J. W. Van Someren
TREAT Early Arthralgia to Reverse or Limit Impending Exacerbation to Rheumatoid arthritis (TREAT EARLIER): a randomized, double-blind, placebo-controlled clinical trial protocol
Ellis Niemantsverdriet, Yousra J. Dakkak, Leonie E. Burgers, Femke Bonte-Mineur, Gerda M. Steup-Beekman, Sjoerd M. van der Kooij, Hido D. Boom, Cornelia F. Allaart, Pascal H. P. de Jong, Annette H. M. van der Helm-van Mil
Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program
Susan N. Hastings, Karen M. Stechuchak, Ashley Choate, Elizabeth P. Mahanna, Courtney Van Houtven, Kelli D. Allen, Virginia Wang, Nina Sperber, Leah Zullig, Hayden B. Bosworth, Cynthia J. Coffman
Therapeutic benefits of music-based synchronous finger tapping in Parkinson’s disease—an fNIRS study protocol for randomized controlled trial in Dalian, China
Lanlan Pu, Nauman Khalid Qureshi, Joanne Ly, Bingwei Zhang, Fengyu Cong, William C. Tang, Zhanhua Liang
Correction to: Graphing and reporting heterogeneous treatment effects through reference classes
James A. Watson, Chris C. Holmes
Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised controlled trial (SEV-COVID Trial): A structured summary of a study protocol for a randomized controlled trial
Prasan Kumar Panda, Arkapal Bandyopadhyay, Budha Charan Singh, Bikram Moirangthem, Gaurav Chikara, Sarama Saha, Yogesh Arvind Bahurupi
Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan
Pradeesh Sivapalan, Charlotte Suppli Ulrik, Therese Sophie Lappere, Josefin Viktoria Eklöf, Saher Burhan Shaker, Uffe Christian Steinholtz Bødtger, Andrea Browatzki, Christian Niels Meyer, Ulla Møller Weinreich, Christian B. Laursen, Tor Biering-Sørensen, Filip Krag Knop, Jens D. Lundgren, Jens-Ulrik Stæhr Jensen
Interleukin-6 Receptor Antibodies for Modulating the Systemic Inflammatory Response after Out-of-Hospital Cardiac Arrest (IMICA): study protocol for a double-blinded, placebo-controlled, single-center, randomized clinical trial
Martin A. S. Meyer, Sebastian Wiberg, Johannes Grand, Jesper Kjaergaard, Christian Hassager
Effectiveness and safety of tenosynovitis of the long head of the biceps brachii with acupuncture: a protocol for a systematic review and meta-analysis
Rongrong Li, Yongliang Jiang, Renjie Hu, Xiaofen He, Jianqiao Fang
Efficacy of an online cognitive behavioral therapy program developed for healthcare workers during the COVID-19 pandemic: the REduction of STress (REST) study protocol for a randomized controlled trial
Luisa Weiner, Fabrice Berna, Nathalie Nourry, François Severac, Pierre Vidailhet, Amaury C. Mengin
Suicide Reduction in Schizophrenia via Exercise (SUnRISE): study protocol for a multi-site, single-blind, randomized clinical trial of aerobic exercise for suicide risk reduction in individuals with schizophrenia
Katie Beck-Felts, Marianne Goodman, Luz H. Ospina, Melanie Wall, Joseph McEvoy, Lars F. Jarskog, Jacob S. Ballon, Matthew N. Bartels, Richard Buchsbaum, Richard P. Sloan, T. Scott Stroup, David Kimhy
Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial
Jane R. Montealegre, Matthew L. Anderson, Susan G. Hilsenbeck, Elizabeth Y. Chiao, Scott B. Cantor, Susan L. Parker, Maria Daheri, Shaun Bulsara, Betsy Escobar, Ashish A. Deshmukh, Maria L. Jibaja-Weiss, Mohammed Zare, Michael E. Scheurer
Letter on Predicting the number of sites needed to deliver a multicentre clinical trial within a limited time frame in the UK
Rosemary Greenwood, Julie Pell, Paula Foscarini-Craggs, Katharine Wale, Ian Thomas, Charlotte Bradbury
Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial
Maria Aparecida Andrade Moreira Machado, Tássia Carina Stafuzza, Luciana Lourenço Ribeiro Vitor, Silgia Aparecida da Costa, Sirlene Maria da Costa, Natalino Lourenço Neto, Thais Marchini Oliveira
“Early transfusion of convalescent plasma in older patients with COVID-19 to prevent disease progression: A structured summary of a study protocol for a randomised controlled trial”
Luciana Teofili, Raffaele Landolfi, Antonella Cingolani, Andrea Antinori, Jacopo Vecchiet, Maurizio Sanguinetti, Antonio Gasbarrini, Tina Pasciuto, Nicoletta Orlando, Silvia Lamonica
The clinical effect of Nano micelles containing curcumin as a therapeutic supplement in patients with COVID-19 and the immune responses balance changes following treatment: A structured summary of a study protocol for a randomised controlled trial
Mehdi Hassaniazad, Behnaz Rahnama Inchehsablagh, Hossein Kamali, Abdolali Tousi, Ebrahim Eftekhar, Mahmoud Reza Jaafari, Mohammad Fathalipour, Sara Nikoofal-Sahlabadi, Hamed Gouklani, Hesam Alizade, Amin Reza Nikpoor
Respiratory support in COPD patients after acute exacerbation with monitoring the quality of support (Rescue2-monitor): an open-label, prospective randomized, controlled, superiority clinical trial comparing hospital- versus home-based acute non-invasive ventilation for patients with hypercapnic chronic obstructive pulmonary disease
J. Gonzalez-Bermejo, D. Hajage, I. Durand-Zaleski, J. M. Arnal, A. Cuvelier, L. Grassion, S. Jaffre, B. Lamia, S. Pontier, A. Prigent, C. Rabec, C. Raherison-Semjen, C. Saint Raymond, J. Soler, W. Trzepizur, J. C. Winck, M. Aguiar, H. Chaves, B. Conde, M. J. Guimarães, P. Lopes, A. Mineiro, S. Moreira, P. Pamplona, C. M. Rodrigues, S. Sousa, A. Antón, A. Córdoba-Izquierdo, C. Embid, C. Esteban González, F. Ezzine, P. Garcia, M. González, I. Guerassimova, D. López, M. Lujan, S. Martí Beltran, J. M. Martinez, F. Masa, N. Pascual, N. Peñacoba, P. Resano, L. Rey, F. Rodríguez Jerez, A. Roncero, Je. Sancho Chinesta, Ja Sayas Catalán
NOn-invasive Vagus nerve stimulation in acute Ischemic Stroke (NOVIS): a study protocol for a randomized clinical trial
Anne van der Meij, Marianne A. A. van Walderveen, Nyika D. Kruyt, Erik W. van Zwet, Eric J. Liebler, Michel D. Ferrari, Marieke J. H. Wermer
Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial
Haiping Deng, Yu Shu, Peiran Lv, Ling Zhao, Ke Cheng, Tingting Zhang, Yi Song, Hua Yang, Hong Tang, Jian Pei, Xueyong Shen
An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial
Ilad Alavi Darazam, Firouze Hatami, Mohammad Mahdi Rabiei, Mohamad Amin Pourhoseingholi, Omid Moradi, Shervin Shokouhi, Mohammad Reza Hajesmaeili, Minoosh Shabani, Seyed Sina Naghibi Irvani
BCG revaccination of health workers in Brazil to improve innate immune responses against COVID-19: A structured summary of a study protocol for a randomised controlled trial
Ana Paula Junqueira-Kipnis, Laura Raniere Borges dos Anjos, Lília Cristina de Souza Barbosa, Adeliane Castro da Costa, Kellen Christina Malheiros Borges, Amanda da Rocha Oliveira Cardoso, Kaio Mota Ribeiro, Sarah Brena Aparecida Rosa, Carine de Castro Souza, Rogério Coutinho das Neves, Guylherme Saraiva, Sueli Meira da Silva, Erika Aparecida Silveira, Marcelo Fouad Rabahi, Marcus Barreto Conte, André Kipnis
Evaluation of the efficacy and safety of Melatonin in moderately ill patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial
Ava Ziaei, Parivash Davoodian, Habib Dadvand, Omid Safa, Soheil Hassanipour, Mahmoud Omidi, Moein Masjedi, Fahime Mahmoudikia, Bahareh Rafiee, Mohammad Fathalipour
Convalescent plasma transfusion therapy in severe COVID-19 patients- a safety, efficacy and dose response study: A structured summary of a study protocol of a phase II randomized controlled trial
Fazle Rabbi Chowdhury, Ashraful Hoque, Forhad Uddin Hasan Chowdhury, Md. Ruhul Amin, Abdur Rahim, M. Mujibur Rahman, Rubina Yasmin, Md. Robed Amin, Md. Titu Miah, Md. Abul Kalam, Md. Sayedur Rahman
PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke—statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment
Jeroen C. de Jonge, Lisa J. Woodhouse, Hendrik Reinink, H. Bart van der Worp, Philip M. Bath
Correction to: Xanthohumol microbiome and signature in healthy adults (the XMaS trial): a phase I triple-masked, placebo-controlled clinical trial
Ryan Bradley, Blake O. Langley, Jennifer J. Ryan, John Phipps, Douglas A. Hanes, Emily Stack, Janet K. Jansson, Thomas O. Metz, Jan Frederik Stevens
Evaluation of the efficacy and safety of favipiravir and interferon compared to lopinavir/ritonavir and interferon in moderately ill patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial
Mehdi Hassaniazad, Ali Bazram, Soheil Hassanipour, Mohammad Fathalipour
Discontinuing adalimumab in patients with controlled juvenile idiopathic arthritis-associated uveitis (ADJUST—Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial): study protocol for a randomised controlled trial
Nisha R. Acharya, Caleb D. Ebert, Nicole K. Kelly, Travis C. Porco, Athimalaipet V. Ramanan, Benjamin F. Arnold, Nisha R. Acharya, Travis C. Porco, Benjamin F. Arnold, Thuy Doan, John A. Gonzales, Emily von Scheven, Shelia T. Angeles-Han, Virginia Miraldi Utz, Albert T. Vitale, Aimee O. Hersh, Rebecca S. Overbury, Erin D. Stahl, Ashley M. Cooper, Melissa A. Lerman, Stefanie L. Davidson, Jennifer E. Thorne, Ekemini A. Ogbu, Kabita Nanda, Erin P. Herlihy, Michelle T. Cabrera, Mark S. Dacey, Katharine F. Moore, Catherine Guly, Andrew D. Dick, Harry Petrushkin, Elena Moraitis, Ameenat L. Solebo, Gavin Cleary, Jose A. Gonzalez-Martin, Sharmila Jandial, Michael P. Clarke, Kristina May, Alice Leahy, Jessy Choi, Daniel Hawley, Narman Puvanachandra, Kate Armon, William D. Renton, Robyn Troutbeck
The effects of exercise training on hypothalamic-pituitary-adrenal axis reactivity and autonomic response to acute stress—a randomized controlled study
Elin Arvidson, Anna Sjörs Dahlman, Mats Börjesson, Lennart Gullstrand, Ingibjörg H. Jonsdottir
Group Post-Admission Cognitive Therapy for Suicidality vs Individual Supportive Therapy for the prevention of repeat suicide attempts: a randomized controlled trial
Laurent S. Chaïb, Jorge Lopez-Castroman, Mocrane Abbar
Explaining the mixed findings of a randomised controlled trial of telehealth with centralised remote support for heart failure: multi-site qualitative study using the NASSS framework
Chrysanthi Papoutsi, Christine A’Court, Joseph Wherton, Sara Shaw, Trisha Greenhalgh
Assessment of boron-containing compounds and oleoylethanolamide supplementation on the recovery trend in patients with COVID-19: A structured summary of a study protocol for a randomized controlled trial
Helda Tutunchi, Majid Mobasseri, Samira Pourmoradian, Hamid Soleimanzadeh, Behnam Kafil, Neda Akbari, Alireza Monshikarimi, Alireza Ostadrahimi
The efficacy of Siddha Medicine, Kabasura Kudineer (KSK) compared to Vitamin C & Zinc (CZ) supplementation in the management of asymptomatic COVID-19 cases: A structured summary of a study protocol for a randomised controlled trial
S. Natarajan, C. Anbarasi, P. Sathiyarajeswaran, P. Manickam, S. Geetha, R. Kathiravan, P. Prathiba, M. Pitchiahkumar, P. Parthiban, K. Kanakavalli, P. Balaji
Tailored implementation of internet-based cognitive behavioural therapy in the multinational context of the ImpleMentAll project: a study protocol for a stepped wedge cluster randomized trial
Leah Bührmann, Josien Schuurmans, Jeroen Ruwaard, Margot Fleuren, Anne Etzelmüller, Jordi Piera-Jiménez, Tracy Finch, Tim Rapley, Sebastian Potthoff, Bruno Aouizerate, Philip J. Batterham, Alison Calear, Helen Christensen, Claus Duedal Pedersen, David Daniel Ebert, Erik Van der Eycken, Naim Fanaj, Claire van Genugten, Denise Hanssen, Ulrich Hegerl, Juliane Hug, Annet Kleiboer, Kim Mathiasen, Carl May, Sevim Mustafa, Caroline Oehler, Arlinda Cerga-Pashoja, Catherine Pope, Gentiana Qirjako, Judith Rosmalen, Ylenia Sacco, Ludovic Samalin, Mette Maria Skjøth, Kristine Tarp, Ingrid Titzler, Enrico Zanalda, Isabel Zbukvic, Johannes H. Smit, Heleen Riper, Christiaan Vis, Alison Calear, Andia Meksi, Anna Sofie Rømer, Anne Etzelmüller, Antoine Yrondi, Arlinda Cerga-Pashoja, Bridianne O’Dea, Bruno Aouizerate, Carl May, Carmen Ceinos, Caroline Oehler, Catherine Pope, Christiaan Vis, Claire van Genugten, Claus Duedal Pedersen, Corinna Gumbmann, David Daniel Ebert, Denise Hanssen, Els Dozeman, Enrico Zanalda, Erik Van der Eycken, Eva Fris, Gentiana Qirjako, Géraldine Visentin, Heleen Riper, Helen Christensen, Ingrid Titzler, Isabel Zbukvic, Jeroen Ruwaard, Johanna Freund, Johannes H. Smit, Jordi Piera-Jiménez, Josep Penya, Josien Schuurmans, Judith Rosmalen, Juliane Hug, Kim Mathiasen, Kristian Kidholm, Kristine Tarp, Leah Bührmann, Ludovic Samalin, Maite Arrillaga, Margot Fleuren, Marion Leboyeer, Martine Pool, Mette Atipei Craggs, Mette Maria Skjøth, Naim Fanaj, Philip J. Batterham, Pia Driessen, Robin Kok, Sebastian Potthoff, Sergi García Redondo, Sevim Mustafa, Tim Rapley, Tracy Finch, Ulrich Hegerl, Ylenia Sacco
Early recognition and response to increases in surgical site infections using optimized statistical process control charts—the Early 2RIS Trial: a multicenter cluster randomized controlled trial with stepped wedge design
Deverick J. Anderson, Iulian Ilieş, Katherine Foy, Nicole Nehls, James C. Benneyan, Yuliya Lokhnygina, Arthur W. Baker
A technology-enhanced model of care for transitional palliative care versus attention control for adult family caregivers in rural or medically underserved areas: study protocol for a randomized controlled trial
Diane E. Holland, Catherine E. Vanderboom, Jay Mandrekar, Bijan J. Borah, Ann Marie Dose, Cory J. Ingram, Joan M. Griffin
Rationale and design of repeated cross-sectional studies to evaluate the reporting quality of trial protocols: the Adherence to SPIrit REcommendations (ASPIRE) study and associated projects
Dmitry Gryaznov, Ayodele Odutayo, Belinda von Niederhäusern, Benjamin Speich, Benjamin Kasenda, Elena Ojeda-Ruiz, Anette Blümle, Stefan Schandelmaier, Dominik Mertz, Yuki Tomonaga, Alain Amstutz, Christiane Pauli-Magnus, Viktoria Gloy, Karin Bischoff, Katharina Wollmann, Laura Rehner, Szimonetta Lohner, Joerg J. Meerpohl, Alain Nordmann, Katharina Klatte, Nilabh Ghosh, Ala Taji Heravi, Jacqueline Wong, Ngai Chow, Patrick Jiho Hong, Kimberly Mc Cord, Sirintip Sricharoenchai, Jason W. Busse, Arnav Agarwal, Ramon Saccilotto, Matthias Schwenkglenks, Giusi Moffa, Lars G. Hemkens, Sally Hopewell, Erik von Elm, Matthias Briel
Safety and Efficacy of Imatinib for Hospitalized Adults with COVID-19: A structured summary of a study protocol for a randomised controlled trial
Ashkan Emadi, Joel V. Chua, Rohit Talwani, Søren M. Bentzen, John Baddley
Prospective reporting of statistical analysis plans for randomised controlled trials
Karla Hemming, Anna Kearney, Carrol Gamble, Tianjing Li, Peter Jüni, An-Wen Chan, Matthew R. Sydes
Practicing outcome-based medical care using pragmatic care trials
Tim E. Darsaut, Jean Raymond
Combined HIV Adolescent Prevention Study (CHAPS): comparison of HIV pre-exposure prophylaxis regimens for adolescents in sub-Saharan Africa—study protocol for a mixed-methods study including a randomised controlled trial
S. Nash, J. Dietrich, A. S. Ssemata, C. Herrera, K. O’Hagan, L. Else, F. Chiodi, C. Kelly, R. Shattock, M. Chirenje, L. Lebina, S. Khoo, L-G Bekker, H. A. Weiss, C. Gray, L. Stranix-Chibanda, P. Kaleebu, J. Seeley, N. Martinson, J. Fox, Nadia Ahmed, Bernice Alinde, Alieu Amara, Millicent Atujuna, Linda-Gail Bekker, Francesca Chiodi, Mike Chirenje, Janan Dietrich, Jeffrey Dorfman, Laura Else, Julie Fox, Clive Gray, Christian Holm Hansen, Carolina Herrera, Stefanie Hornschuh, Ayoub Kakande, Pontiano Kaleebu, Charles Kelly, Saye Khoo, Mamkiri Khunwane, Limaktso Lebina, Joseph Makhura, Nomvuyo Mangxilana, Neil Martinson, Richard Muhumuza, Freddie Mukasa Kibengo, Gertrude Mutonyi, Stephen Nash, Teacler Nematadzira, Lumka Nobula, Kyle O’Hagan, Geoffrey Odoch, Natasha Pilay, Elzette Rousseau, Eugene Ruzagira, Ntombexolo Seatlholo, Janet Seeley, Thabiso Seiphetlo, Jennifer Serwanga, Robin Shattock, Andrew S. Ssemata, Lynda Stranix-Chibanda, Gugulethu Tshabalala, Helen Weiss
Stuck-moving needle acupuncture myofascial trigger point to treat idiopathic frozen shoulder: study protocol for a randomized controlled trial
Yang Bai, Ying Wang, Bo Chen, Yinan Qin, Qianqian Lei, Hailong Zhao, Jingbao Lu, Qian Fan, Yali Wang, Hongbo Song, Maomao Cheng, Wei Wang, Shengen Hu, Yuan Hao Du, Tian Xia
Atorvastatin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection: A structured summary of a study protocol for a randomised controlled trial
Nirmal Ghati, Ambuj Roy, Sushma Bhatnagar, Sumit Bhati, Sudha Bhushan, Manjit Mahendran, Abhishek Thakur, Pawan Tiwari, Tanima Dwivedi, Kalaivani Mani, Ritu Gupta, Anant Mohan, Rakesh Garg, Anita Saxena, Randeep Guleria, Siddharthan Deepti
First-line support for assistance in breathing in children: statistical and health economic analysis plan for the FIRST-ABC trial
Izabella Orzechowska, M. Zia Sadique, Karen Thomas, Peter Davis, Kevin P. Morris, Paul R. Mouncey, Mark J. Peters, Alvin Richards-Belle, Lyvonne N. Tume, Padmanabhan Ramnarayan, David A. Harrison
A Trial of Favipiravir and Hydroxychloroquine combination in Adults Hospitalized with moderate and severe Covid-19: A structured summary of a study protocol for a randomised controlled trial
Mohammad Bosaeed, Ebrahim Mahmoud, Mohammad Hussein, Ahmad Alharbi, Abdulrahman Alsaedy, Adel Alothman, Majed Aljeraisy, Hajar Alqahtani, Marwan Nashabat, Badriah Almutairi, Manar Almaghaslah, Omar Aldibasi, Sameera AlJohani, Abderrezak Bouchama, Yaseen Arabi, Ahmad Alaskar
Hyperimmune anti-COVID-19 IVIG (C-IVIG) Therapy for Passive Immunization of Severe and Critically Ill COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial
Shaukat Ali, Shobha Luxmi, Fatima Anjum, Sheikh Muhammad Muhaymin, Syed Muneeb Uddin, Ayesha Ali, Mir Rashid Ali, Sohaib Tauheed, Mujtaba Khan, Mohsin Bajwa, Saif Ullah Baig, Elisha Shalim, Iqra Ahmed, Abdul Samad Khan, Saeed Quraishy
Salivary and Nasal Detection of the SARS-CoV-2 Virus After Antiviral Mouthrinses (BBCovid): A structured summary of a study protocol for a randomised controlled trial
Florence Carrouel, Stéphane Viennot, Martine Valette, Jean-Marie Cohen, Claude Dussart, Denis Bourgeois
Parental perspectives long term after neonatal clinical trial participation: a survey
Thomas Salaets, Emilie Lavrysen, Anne Smits, Sophie Vanhaesebrouck, Maissa Rayyan, Els Ortibus, Jaan Toelen, Laurence Claes, Karel Allegaert
Efficacy of Tong-Xie-Yao-Fang granule and its impact on whole transcriptome profiling in diarrhea-predominant irritable bowel syndrome patients: study protocol for a randomized controlled trial
Yan Wang, Yong-quan Huang, Shui-lian Zhu, Chang-rong Zhang, Xin-lin Chen, Qiu-ke Hou, Feng-bin Liu
A study protocol for HEalth-Related quality of life-intervention in survivors of Breast and other cancers experiencing cancer-related fatigue using TraditionAL Chinese Medicine: the HERBAL trial
Ning Yi Yap, Wei Sheng Loo, Huang Fang Zheng, Quan Ming Tan, Tze Kiat Tan, Leona Yan Peng Quek, Chia Jie Tan, Yi Long Toh, Chiu Chin Ng, Seng Kok Ang, Veronique Kiak Mien Tan, Han Kiat Ho, Lita Chew, Kiley Wei-Jen Loh, Tira Jing Ying Tan, Alexandre Chan
Effectiveness of theta and gamma electroacupuncture for post-stroke patients on working memory and electrophysiology: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial
Jing-Jing Xu, Meng Ren, Jing-Jun Zhao, Jia-Jia Wu, Si-Cong Zhang, Yan-Biao Zhong, Shu-Tian Xu, Zhong-Yao Cao, Zhi-Qing Zhou, Yuan-Li Li, Chun-Lei Shan
Evaluation of the efficacy and safety of fire needle compared to filiform needle on knee osteoarthritis: study protocol for a randomized controlled trial
Yuanjie Gao, Lu Liu, Bin Li, Jing Guo, Huilin Liu, Shaosong Wang, Fan Zhang, Xu Ji, Yuanbo Fu, Yizhan Wang, Jingqing Sun, Fang Yuan
The rescue intervention strategy for asthma patients under severe air pollution: a protocol for a single-centre prospective randomized controlled trial
Xiaoyu Yang, Junjun Huang, Yan Hu, Cuiyan Guo, Xi Wang, Zhao Yang, Tianyu Zhou, Guangfa Wang
Effects of strategies to improve general practitioner-nurse collaboration and communication in regard to hospital admissions of nursing home residents (interprof ACT): study protocol for a cluster randomised controlled trial
Christiane Müller, Berit Hesjedal-Streller, Nina Fleischmann, Britta Tetzlaff, Tina Mallon, Martin Scherer, Sascha Köpke, Katrin Balzer, Linda Gärtner, Indre Maurer, Tim Friede, Hans-Helmut König, Eva Hummers
A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE cluster randomised controlled trial protocol
Marcia Scazufca, Carina Akemi Nakamura, Tim J. Peters, Maiara Garcia Henrique, Antônio Seabra, Ehidee Gomez La Rotta, Renato M. Franzin, Daniele Ferreira Martins, Pepijn Van de Ven, William Hollingworth, Ricardo Araya
Acupuncture for chronic stable angina pectoris based on the theory of Meridian-Viscera Association: study protocol for a multicenter randomized controlled trial
Zhaoxuan He, Yi Yang, Qiao Wen, Tao Yin, Zhengjie Li, Peihong Ma, Hui Zheng, Yunhong Yang, Yongliang Jiang, Jianqiao Fang, Lei Lan, Fang Zeng
Process evaluation within pragmatic randomised controlled trials: what is it, why is it done, and can we find it?—a systematic review
Caroline French, Hilary Pinnock, Gordon Forbes, Imogen Skene, Stephanie J. C. Taylor
Analysis of multicenter clinical trials with very low event rates
Jiyu Kim, Andrea B. Troxel, Scott D. Halpern, Kevin G. Volpp, Brennan C. Kahan, Tim P. Morris, Michael O. Harhay
Negative pressure wound therapy (NPWT) on closed incisions to prevent surgical site infection in high-risk patients in hepatopancreatobiliary surgery: study protocol for a randomized controlled trial—the NP-SSI trial
Frank W. Brennfleck, Lena Linsenmeier, Henrik H.G. Junger, Katharina M. Schmidt, Jens M. Werner, Daniel Woehl, Florian Zeman, Ingrid Mutzbauer, James A. Hutchinson, Edward K. Geissler, Hans J. Schlitt, Stefan M. Brunner
The effect of surfactant on clinical outcome of patients with COVID-19 under mechanical ventilation: A structured summary of a study protocol for a randomised controlled trial
Ali Dabbagh, Samira Rajaei, Mehdi Ghahremani, Mohammad Fathi, Nilofar Massoudi, Sasan Tavana, Kamal Fani, Navid Nooraee, Nasser Malekpour Alamdari, Sara Besharat, Arash Najafi Abrandabadi, Ali Pirsalehi, Mohammad Ali Khabiri Khatiri
Cov-hep study: heparin in standard anticoagulation based on citrate for continuous veno-venous hemodialysis in patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial
Paulo Ricardo Gessolo Lins, Claudia Coimbra César de Albuquerque, Camila Fernandes Assis, Bruna Cristine Duarte Rodrigues, Beatriz Pinto e Siqueira Campos, Eduardo de Oliveira Valle, Carla Paulina Sandoval Cabrera, Jeison de Oliveira Gois, Gabriela Cardoso Segura, Fernando Louzada Strufaldi, Lorena Catelan Mainardes, Rayra Gomes Ribeiro, Daniela Del Pilar Via Reque Cortes, Luciana Gil Lutf, Márcia Fernanda Arantes de Oliveira, Gabriel Teixeira Montezuma Sales, Igor Smolentzov, Bernardo Vergara Reichert, Lucia Andrade, Victor Faria Seabra, Camila Eleuterio Rodrigues
Measuring effects on intima-media thickness: an evaluation of rosuvastatin in Chinese subjects with subclinical atherosclerosis—design, rationale, and methodology of the METEOR-China study
Yilong Wang, Anxin Wang, Hongwei Li, Zhanquan Li, Bo Hu, Xiaogang Li, Huaguang Zheng, Lu Fu, Hongtao Hu, Zhiyu Nie, Yulin Qin, Bilian Zhao, Di Wei, Björn W. Karlson, Michiel L. Bots, Yundai Chen, Yongjun Wang
A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©
Klajdi Puka, Karen Bax, Andrea Andrade, Margo Devries-Rizzo, Hema Gangam, Simon Levin, Maryam N. Nouri, Asuri N. Prasad, Mary Secco, Guangyong Zou, Kathy N. Speechley
Effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine: a single-centre, randomised, double-blind, sham-controlled phase 2 trial (Magnet-EM)
Nabil Izzaatie Mohamad Safiai, Nur Ain Amir, Hamidon Basri, Liyana Najwa Inche Mat, Fan Kee Hoo, Abdul Hanif Khan Yusof Khan, Wei Chao Loh, Peck Kee Chia, Vasudevan Ramachandran, Hazwan Mat Din, Intan Nureslyna Samsudin, Aaron Fernandez, Mohd Hazmi Mohamed, Siew Mooi Ching, Hasnur Zaman Hashim, Wan Aliaa Wan Sulaiman
Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide: study protocol for a randomized controlled trial in veterans
Melanie L. Bozzay, Jennifer M. Primack, Hannah R. Swearingen, Jennifer Barredo, Noah S. Philip
The BEACON study: protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario
Simon Hatcher, Marnin Heisel, Oyedeji Ayonrinde, Julie K. Campbell, Ian Colman, Daniel J. Corsi, Nicole E. Edgar, Lindsay Gillett, Sidney H. Kennedy, Sophia Lakatoo Hunt, Paul Links, Sarah MacLean, Viraj Mehta, Christopher Mushquash, Alicia Raimundo, Sakina J. Rizvi, Refik Saskin, Ayal Schaffer, Alaaddin Sidahmed, Mark Sinyor, Claudio Soares, Monica Taljaard, Valerie Testa, Kednapa Thavorn, Venkatesh Thiruganasambandamoorthy, Christian Vaillancourt
Assessing effectiveness and implementation of a perioperative enhanced recovery protocol for children undergoing surgery: study protocol for a prospective, stepped-wedge, cluster, randomized, controlled clinical trial
Mehul V. Raval, Erin Wymore, Martha-Conley E. Ingram, Yao Tian, Julie K. Johnson, Jane L. Holl
Correction to: Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial
Christina M. Eckhardt, Matthew J. Cummings, Kartik N. Rajagopalan, Sarah Borden, Zachary C. Bitan, Allison Wolf, Alex Kantor, Thomas Briese, Benjamin J. Meyer, Samuel D. Jacobson, Dawn Scotto, Nischay Mishra, Neena M. Philip, Brie A. Stotler, Joseph Schwartz, Beth Shaz, Steven L. Spitalnik, Andrew Eisenberger, Eldad A. Hod Jessica Justman, Ken Cheung, W. Ian Lipkin, Max R. O’Donnell
Case management after acquired brain injury compared to care as usual: study protocol for a 2-year pragmatic randomized controlled superiority trial with two parallel groups
Annemarie P. M. Stiekema, Christine Resch, Mireille Donkervoort, Natska Jansen, Kitty H. M. Jurrius, Judith M. Zadoks, Caroline M. van Heugten
CovEMERALD: Assessing the feasibility and preliminary effectiveness of remotely delivered Eye Movement Desensitisation and Reprocessing following Covid-19 related critical illness: A structured summary of a study protocol for a randomised controlled trial
Andrew Bates, Sophie Rushbrook, Elan Shapiro, Michael Grocott, Rebecca Cusack
Analysis and reporting of stratified cluster randomized trials—a systematic survey
Sayem Borhan, Alexandra Papaioannou, Jinhui Ma, Jonathan Adachi, Lehana Thabane
Digital crowdsourced intervention to promote HIV testing among MSM in China: study protocol for a cluster randomized controlled trial
Ci Ren, Joseph D. Tucker, Weiming Tang, Xiaorun Tao, Meizhen Liao, Guoyong Wang, Kedi Jiao, Zece Xu, Zhe Zhao, Yu Yan, Yuxi Lin, Chuanxi Li, Lin Wang, Yijun Li, Dianmin Kang, Wei Ma
Clinical trials with cannabis medicines—guidance for ethics committees, governance officers and researchers to streamline ethics applications and ensuring patient safety: considerations from the Australian experience
Jennifer H. Martin, Courtney Hill, Anna Walsh, Daryl Efron, Kaitlyn Taylor, Michael Kennedy, Rachel Galettis, Paul Lightfoot, Julie Hanson, Helen Irving, Meera Agar, Judith Lacey
Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention (eMBI) on maternal mental health during pregnancy: the mindmom study protocol for a randomized controlled clinical trial
Mitho Müller, Lina Maria Matthies, Maren Goetz, Harald Abele, Sara Yvonne Brucker, Armin Bauer, Johanna Graf, Stephan Zipfel, Lena Hasemann, Markus Wallwiener, Stephanie Wallwiener
Zilucoplan in patients with acute hypoxic respiratory failure due to COVID-19 (ZILU-COV): A structured summary of a study protocol for a randomised controlled trial
Jozefien Declercq, Cedric Bosteels, Karel Van Damme, Elisabeth De Leeuw, Bastiaan Maes, Ans Vandecauter, Stefanie Vermeersch, Anja Delporte, Bénédicte Demeyere, Marnik Vuylsteke, Marianna Lalla, Trevor Smart, Laurent Detalle, René Bouw, Johannes Streffer, Thibo Degeeter, Marie Vergotte, Tanguy Guisez, Eva Van Braeckel, Catherine Van Der Straeten, Bart N. Lambrecht
Glasgow Early Treatment Arm Favirpiravir (GETAFIX) for adults with early stage COVID-19: A structured summary of a study protocol for a randomised controlled trial
Catherine R. Hanna, Kevin G. Blyth, Glenn Burley, Samantha Carmichael, Carol Evans, Samantha Hinsley, Ibrahim Khadra, Saye Khoo, Liz-Anne Lewsley, Robert R. Jones, Raman Sharma, Andrea Taladriz-Sender, Emma C. Thomson, Janet T. Scott
Effects of tibial and parasacral nerve electrostimulation techniques on women with poststroke overactive bladder: study protocol for a randomized controlled trial
Thais Alves Candido, Bruna Miranda Ribeiro, Cristiane Rodrigues Cardoso de Araújo, Rogério de Melo Costa Pinto, Ana Paula Magalhães Resende, Vanessa Santos Pereira-Baldon
Developing and testing the effectiveness of a novel online integrated treatment for problem gambling and tobacco smoking: a protocol for an open-label randomized controlled trial
Elena Bilevicius, Alanna Single, Chris Baumgartner, Van Bui, Tyler Kempe, Michael P. Schaub, Sherry H. Stewart, James MacKillop, David C. Hodgins, Jeffrey D. Wardell, Roisin O’Connor, Jennifer Read, Heather Hadjistavropoulos, Christopher Sundstrom, Matthew T. Keough
The Shamiri group intervention for adolescent anxiety and depression: study protocol for a randomized controlled trial of a lay-provider-delivered, school-based intervention in Kenya
Tom L. Osborn, Katherine E. Venturo-Conerly, Akash R. Wasil, Micaela Rodriguez, Elizabeth Roe, Rediet Alemu, Susana Arango G., Jenny Gan, Christine Wasanga, Jessica L. Schleider, John R. Weisz
Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial
Emanuele Bosi, Carlo Bosi, Patrizia Rovere Querini, Nicasio Mancini, Giliola Calori, Annalisa Ruggeri, Cecilia Canzonieri, Luciano Callegaro, Massimo Clementi, Francesco De Cobelli, Massimo Filippi, Marco Bregni
Prone positioning in non-intubated patients with COVID-19 associated acute respiratory failure, the PRO-CARF trial: A structured summary of a study protocol for a randomised controlled trial
Miguel Á. Ibarra-Estrada, Miguel Marín-Rosales, Roxana García-Salcido, Sara A. Aguirre-Díaz, Alexandra Vargas-Obieta, Quetzalcóatl Chávez-Peña, José A. López-Pulgarín, Julio C. Mijangos-Méndez, Guadalupe Aguirre-Avalos
Comparison of four COVID-19 screening strategies to facilitate early case identification within the homeless shelter population: A structured summary of a study protocol for a randomised controlled trial
Timothy O’Shea, Lawrence Mbuagbaw, Vaibhav Mokashi, David Bulir, Jodi Gilchrist, Nicole Smieja, Sylvia Chong, Sarah Marttala, Valentina Vera, Anna Cvetkovic, Marek Smieja
Letter to the editor: Study Summary - Randomized Control Trial of Omega-3 Fatty Acid Supplementation for the Treatment of COVID-19 Related Olfactory Dysfunction
David Lerner, Katherine Garvey, Annie Arrighi-Allisan, Andrey Filimonov, Peter Filip, Katherine Liu, Sen Ninan, Madeleine Schaberg, Patrick Colley, Anthony Del Signore, Satish Govindaraj, Alfred Marc Iloreta
Safety and efficacy of herbal extracts to restore respiratory health and improve innate immunity in COVID-19 positive patients with mild to moderate severity: A structured summary of a study protocol for a randomised controlled trial
Hrishikesh Rangnekar, Suresh Patankar, Kishor Suryawanshi, Pravin Soni
An automated structured education intervention based on a smartphone app in Chinese patients with type 1 diabetes: a protocol for a single-blinded randomized controlled trial
Fansu Huang, Xinyin Wu, Yuting Xie, Fang Liu, Juan Li, Xia Li, Zhiguang Zhou
Effect of targeted vs standard fortification of breast milk on growth and development of preterm infants (≤ 32 weeks): study protocol for a randomized controlled trial
Joanna Seliga-Siwecka, Anna Chmielewska, Katarzyna Jasińska
One Plus One Equals Two—will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma
M. Edqvist, H. G. Dahlen, C. Häggsgård, H. Tern, K. Ängeby, G. Tegerstedt, P. Teleman, G. Ajne, C. Rubertsson
A novel human laboratory model for screening medications for alcohol use disorder
Diana Ho, Brandon Towns, Erica N. Grodin, Lara A. Ray
Anakinra: efficacy in the management of fever during neutropenia and mucositis in autologous stem cell transplantation (AFFECT-2)—study protocol for a multicenter randomized double-blind placebo-controlled trial
Charlotte E. M. de Mooij, Lenneke F. J. van Groningen, Anton F. J. de Haan, Bart J. Biemond, Martijn Bakker, Walter J. F. M. van der Velden, Nicole M. A. Blijlevens
Oral corticosteroids for post-infectious cough in adults: study protocol for a double-blind randomized placebo-controlled trial in Swiss family practices (OSPIC trial)
Christoph Merlo, Stefan Essig, D. Oana Brancati-Badarau, Jörg Daniel Leuppi, Benjamin Speich, Tobias E. Erlanger, Lars G. Hemkens, Andreas Zeller
Postoperative controls of ventilation tubes in children by general practitioner or otolaryngologist? Study protocol for a multicenter randomized non-inferiority study (The ConVenTu study)
Bjarne Austad, Ann Helen Nilsen, Anne-Sofie Helvik, Grethe Albrektsen, Ståle Nordgård, Wenche Moe Thorstensen
Effects of Keluoxin capsule combined with losartan potassium on diabetic kidney disease: study protocol for a randomized double-blind placebo-controlled multicenter clinical trial
Rui Wu, Fan Wei, Lianlian Qu, Litao Bai, Jun Li, Fei Li, Weitian Yan, Qiuhong Wang, Junping Wei
Intralipid postconditioning in patients of cardiac surgery undergoing cardiopulmonary bypass (iCPB): study protocol for a randomized controlled trial
Yuan Yuan, Hui Xiong, Yan Zhang, Hong Yu, Rong-Hua Zhou
Parents’ understanding and motivation to take part in a randomized controlled trial in the field of adolescent mental health: a qualitative study
Sally O’Keeffe, Katharina Weitkamp, Danny Isaacs, Mary Target, Virginia Eatough, Nick Midgley
Hemoperfusion with HA380 in acute type A aortic dissection patients undergoing aortic arch operation (HPAO): a randomized, controlled, double-blind clinical trial
Jing Yang, Dong Ji, Yue-Qian Zhu, Yun Ren, Xun Zhang, Hong-Yu Dai, Xu Sun, Yi Zhou, Zhi-Yuan Chen, Qing-Guo Li, Hao Yao
Comparison of continuous versus intermittent enteral nutrition in critically ill patients (COINN): study protocol for a randomized comparative effectiveness trial
Ondrej Hrdy, Kamil Vrbica, Eva Strazevska, Petr Suk, Lenka Souckova, Radka Stepanova, Igor Sas, Roman Gal
Point-of-care molecular testing and antiviral treatment of influenza in residents of homeless shelters in Seattle, WA: study protocol for a stepped-wedge cluster-randomized controlled trial
Kira L. Newman, Julia H. Rogers, Denise McCulloch, Naomi Wilcox, Janet A. Englund, Michael Boeckh, Timothy M. Uyeki, Michael L. Jackson, Lea Starita, James P. Hughes, Helen Y. Chu
Corticosteroids versus clobazam in epileptic encephalopathy with ESES: a European multicentre randomised controlled clinical trial (RESCUE ESES*)
Bart van den Munckhof, Alexis Arzimanoglou, Emilio Perucca, Heleen C. van Teeseling, Frans S. S. Leijten, Kees P. J. Braun, Floor E. Jansen, Anna Jansen, Patrick van Bogaert, Lieven Lagae, Guido Rubboli, Eija Gaily, Pierangelo Veggiotti, Gaetano Cantalupo, Giuseppe Gobbi, Dana Craiu, Petia Dimova, Thomas Bast, Julia Jacobs, Sarah von Spiczak, Anja Lübbig, Stéphane Auvin, Anne de Saint-Martin, J. Helen Cross, Richard Chin, Sameer Zuberi, Irene Garcia Morales, Georgia Ramantani
Individualized hemodynamic optimization guided by indirect measurement of the respiratory exchange ratio in major surgery: study protocol for a randomized controlled trial (the OPHIQUE study)
Stéphane Bar, Pierre Boivin, Younes El Amine, Richard Descamps, Mouhamed Moussa, Osama Abou Arab, Marc-Olivier Fischer, Hervé Dupont, Emmanuel Lorne, Pierre-Grégoire Guinot
UVR-sensor wearable device intervention to improve sun behaviors and reduce sunburns in melanoma survivors: study protocol of a parallel-group randomized controlled trial
Rachel I. Vogel, Rebekah H. Nagler, Rehana L. Ahmed, Katherine Brown, Xianghua Luo, Brian C. Martinson, DeAnn Lazovich
Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low- and middle-income setting: study protocol for a randomised controlled trial (CRADLE-4 Trial)
Alice Beardmore-Gray, Nicola Vousden, Umesh Charantimath, Geetanjali Katageri, Mrutyunjaya Bellad, Kunda Kapembwa, Sebastian Chinkoyo, Bellington Vwalika, Matthew Clark, Rachael Hunter, Paul Seed, Shivaprasad Goudar, Lucy C. Chappell, Andrew Shennan
An investigation into the factors affecting investigator-initiated trial start-up in Ireland
Lauren Leddy, Prasanth Sukumar, Lydia O’Sullivan, Fionnuala Keane, Declan Devane, Peter Doran
Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial
Rupesh Kotecha, Brian J. Schiro, Justin Sporrer, Muni Rubens, Haley R. Appel, Kathleen S. Calienes, Belinda Boulanger, Marietsy V. Pujol, Deborah T. Suarez, Ashley Pena, Alex Kudryashev, Minesh P. Mehta
Optimizing the efficiency and implementation of cash transfers to improve adherence to antiretroviral therapy: study protocol for a cluster randomized controlled trial
Laura Packel, Prosper Njau, Carolyn Fahey, Angela Ramadhani, William H. Dow, Nicholas P. Jewell, Sandra McCoy
Ivermectin to prevent hospitalizations in patients with COVID-19 (IVERCOR-COVID19): a structured summary of a study protocol for a randomized controlled trial
Julio Vallejos, Rodrigo Zoni, Maria Bangher, Silvina Villamandos, Angelina Bobadilla, Fabian Plano, Claudia Campias, Evangelina Chaparro Campias, Fernando Achinelli, Hector A. Guglielmone, Jorge Ojeda, Fernanda Medina, Diego Farizano Salazar, Gerardo Andino, Natalia E. Ruiz Diaz, Pablo Kawerin, Elba Meza, Silvana Dellamea, Antonia Aquino, Victor Flores, Carolina N. Martemucci, María Mercedes Vernengo, Silvina María Martinez, Juan Emanuel Segovia, María Gabriela Aguirre
Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial
Giuseppe Tarantini, Marco Mojoli, Ferdinando Varbella, Roberto Caporale, Stefano Rigattieri, Giuseppe Andò, Plinio Cirillo, Simona Pierini, Andrea Santarelli, Paolo Sganzerla, Nicoletta De Cesare, Ugo Limbruno, Alessandro Lupi, Roberto Ricci, Carlo Cernetti, Luca Favero, Francesco Saia, Loris Roncon, Valeria Gasparetto, Marco Ferlini, Federico Ronco, Luca Ferri, Daniela Trabattoni, Alessandra Russo, Vincenzo Guiducci, Carlo Penzo, Fabio Tarantino, Ciro Mauro, Alfredo Marchese, Battistina Castiglioni, Alessio La Manna, Matteo Martinato, Dario Gregori, Dominick J. Angiolillo, Giuseppe Musumeci
Correction to: BCG revaccination of health workers in Brazil to improve innate immune responses against COVID-19: A structured summary of a study protocol for a randomised controlled trial
Ana Paula Junqueira-Kipnis, Laura Raniere Borges dos Anjos, Lília Cristina de Souza Barbosa, Adeliane Castro da Costa, Kellen Christina Malheiros Borges, Amanda da Rocha Oliveira Cardoso, Kaio Mota Ribeiro, Sarah Brena Aparecida Rosa, Carine de Castro Souza, Rogério Coutinho das Neves, Guylherme Saraiva, Sueli Meira da Silva, Erika Aparecida Silveira, Marcelo Fouad Rabahi, Marcus Barreto Conte, André Kipnis
Remote continuous glucose monitoring during the COVID-19 pandemic in quarantined hospitalized patients in Denmark: A structured summary of a study protocol for a randomized controlled trial
Carina Kirstine Klarskov, Birgitte Lindegaard, Ulrik Pedersen-Bjergaard, Peter Lommer Kristensen
CompLement C5 Antibodies for decreasing brain injury after aneurysmal Subarachnoid Haemorrhage (CLASH): study protocol for a randomised controlled phase II clinical trial
Inez Koopman, Gabriel J. E. Rinkel, Mervyn D. I. Vergouwen, I. Koopman, R. W. P. Tack, H. F. Wunderink, A. H. W. Bruns, I. van der Schaaf, K. A. Gelderman, J. P. Greving, A. J. C. Slooter, A. van der Zwan, M. Bartels, G. J. E. Rinkel, M. D. I. Vergouwen
Effect of “motivational interviewing” and “information, motivation, and behavioral skills” counseling interventions on choosing the mode of delivery in pregnant women: a study protocol for a randomized controlled trial
Mahboubeh Shirzad, Elham Shakibazadeh, Abbas Rahimi Foroushani, Mehrandokht Abedini, Hamid Poursharifi, Sohrab Babaei
Update to the FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical analysis plan for the trials and for the individual patient data meta-analysis
Gillian Elizabeth Mead, Catriona Graham, Laurent Billot, Per Näsman, Erik Lundström, Steff Lewis, Graeme J. Hankey, Maree L. Hackett, John Forbes, Martin Dennis
Feasibility and initial efficacy of a high-intensity interval training program using adaptive equipment in persons with multiple sclerosis who have walking disability: study protocol for a single-group, feasibility trial
Elizabeth A. Hubbard, Robert W. Motl, David J. Elmer
The A2B trial, antibiotic prophylaxis for excision-graft surgery in burn patients: a multicenter randomized double-blind study
François Dépret, Boris Farny, Mathieu Jeanne, Kada Klouche, Thomas Leclerc, Karine Nouette-Gaulain, Olivier Pantet, Francis Rémerand, Antoine Roquilly, Anne-Françoise Rousseau, Simon Sztajnic, Sandrine Wiramus, Eric Vicaut, Matthieu Legrand, François Dépret, Matthieu Legrand, Thomas Leclerc, Boris Farny, Sandrine Wiramus, Antoine Roquilly, Mathieu Jeanne, Francis Rémerand, Kada Klouche, Simon Sztajnic, Karine Nouette, Barraud Damien, Anne-Françoise Rousseau, Olivier Pantet
Impact of a package of diagnostic tools, clinical algorithm, and training and communication on outpatient acute fever case management in low- and middle-income countries: protocol for a randomized controlled trial
Olawale Salami, Philip Horgan, Catrin E. Moore, Abhishek Giri, Asadu Sserwanga, Ashish Pathak, Buddha Basnyat, Francois Kiemde, Frank Smithuis, Freddy Kitutu, Gajanan Phutke, Halidou Tinto, Heidi Hopkins, James Kapisi, Myo Maung Maung Swe, Neelam Taneja, Rita Baiden, Shanta Dutta, Adelaide Compaore, David Kaawa-Mafigiri, Rashida Hussein, Summita Udas Shakya, Vida Kukula, Stefano Ongarello, Anjana Tomar, Sarabjit S. Chadha, Kamini Walia, Cassandra Kelly-Cirino, Piero Olliaro
StudiCare mindfulness—study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and “on demand” guidance
Ann-Marie Küchler, Dana Schultchen, Olga Pollatos, Morten Moshagen, David D. Ebert, Harald Baumeister
A randomized clinical trial of a theory-based fentanyl overdose education and fentanyl test strip distribution intervention to reduce rates of opioid overdose: study protocol for a randomized controlled trial
Brendan P. Jacka, Jacqueline E. Goldman, Jesse L. Yedinak, Edward Bernstein, Scott E. Hadland, Jane A. Buxton, Susan G. Sherman, Katie B. Biello, Brandon D. L. Marshall
DOuble SEquential External Defibrillation for Refractory Ventricular Fibrillation (DOSE VF): study protocol for a randomized controlled trial
Ian R. Drennan, Paul Dorian, Shelley McLeod, Ruxandra Pinto, Damon C. Scales, Linda Turner, Michael Feldman, P. Richard Verbeek, Laurie J. Morrison, Sheldon Cheskes
Comparison of peri-implant submucosal microbiota in arches with zirconia or titanium implant-supported fixed complete dental prostheses: a study protocol for a randomized controlled trial
Pingyi Jia, Jingwen Yang, Zhaoguo Yue, Jianzhang Liu, Qi Liu, Zhongning Liu, Lin Tang, Jianxia Hou
Assessing the effect of hyperbaric oxygen therapy in breast cancer patients with late radiation toxicity (HONEY trial): a trial protocol using a trial within a cohort design
M. C. T. Batenburg, H. J. G. D. van den Bongard, C. E. Kleynen, W. Maarse, A. Witkamp, M. Ernst, A. Doeksen, T. van Dalen, M. Sier, E. J. P. Schoenmaeckers, I. O. Baas, H. M. Verkooijen
A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial
Timothy Devos, Tatjana Geukens, Alexander Schauwvlieghe, Kevin K. Ariën, Cyril Barbezange, Myriam Cleeren, Veerle Compernolle, Nicolas Dauby, Daniël Desmecht, David Grimaldi, Bart N. Lambrecht, Anne Luyten, Piet Maes, Michel Moutschen, Marta Romano, Lucie Seyler, Michel Toungouz Nevessignsky, Katleen Vandenberghe, Johan van Griensven, Geert Verbeke, Erika Vlieghe, Jean Cyr Yombi, Laurens Liesenborghs, Peter Verhamme, Geert Meyfroidt
Designing process evaluations using case study to explore the context of complex interventions evaluated in trials
Aileen Grant, Carol Bugge, Mary Wells
Hydroxyurea Optimization through Precision Study (HOPS): study protocol for a randomized, multicenter trial in children with sickle cell anemia
Emily R. Meier, Susan E. Creary, Matthew M. Heeney, Min Dong, Abena O. Appiah-Kubi, Stephen C. Nelson, Omar Niss, Connie Piccone, Maa-Ohui Quarmyne, Charles T. Quinn, Kay L. Saving, John P. Scott, Ravi Talati, Teresa S. Latham, Amanda Pfeiffer, Lisa M. Shook, Alexander A. Vinks, Adam Lane, Patrick T. McGann
Platelet-rich plasma versus corticosteroid injection for treatment of trigger finger: study protocol for a prospective randomized triple-blind placebo-controlled trial
Samuli Aspinen, Panu H. Nordback, Turkka Anttila, Susanna Stjernberg-Salmela, Jorma Ryhänen, Jussi Kosola
Conquering hypertension in Vietnam—solutions at grassroots level: study protocol of a cluster randomized controlled trial
Duc A. Ha, Oanh T. Tran, Hoa L. Nguyen, Germán Chiriboga, Robert J. Goldberg, Van H. Phan, Cuc T. Nguyen, Giang H. Nguyen, Hien V. Pham, Thang T. Nguyen, Thanh T. Le, Jeroan J. Allison
Effect of barberry (Berberis vulgaris) consumption on blood pressure, plasma lipids, and inflammation in patients with hypertension and other cardiovascular risk factors: study protocol for a randomized clinical trial
Hadi Emamat, Ali Zahedmehr, Sanaz Asadian, Hadith Tangestani, Javad Nasrollahzadeh
Test evaluation trials present different challenges for trial managers compared to intervention trials
Caroline Rick, Sue Mallett, James Brown, Ryan Ottridge, Andrew Palmer, Victoria Parker, Lee Priest, Jonathan J. Deeks
Comparative effectiveness of direct admission and admission through emergency departments for children: a randomized stepped wedge study protocol
JoAnna K. Leyenaar, Corrie E. McDaniel, Stephanie C. Acquilano, Andrew P. Schaefer, Martha L. Bruce, A. James O’Malley
Neurological and psychological mechanisms of the specific and nonspecific effects of acupuncture on knee osteoarthritis: study protocol for a randomized, controlled, crossover trial
Jin-Ling Li, Cun-Zhi Liu, Na Zhang, Chao-Qun Yan, Jian-Feng Tu, Li-Qiong Wang, You-Sheng Qi, Jun-Hong Liu, Xu Wang
Comparison of GlideScope™ visualization and neck flexion with lateral neck pressure nasogastric tube insertion techniques in anesthetized patients: a randomized clinical study
Pitchaporn Purngpipattrakul, Suttasinee Petsakul, Sunisa Chatmonkolchart, Kanjana Nuanjun, Somrutai Boonchuduang
Evaluation of the effect of curcumin and zinc co-supplementation on glycemic measurements, lipid profiles, and inflammatory and antioxidant biomarkers in overweight or obese prediabetic patients: a study protocol for a randomized double-blind placebo-controlled phase 2 clinical trial
Majid Karandish, Hassan Mozaffari-khosravi, Seyed Mohammad Mohammadi, Maryam Azhdari, Bahman Cheraghian
A randomised controlled trial of heavy shoulder strengthening exercise in patients with hypermobility spectrum disorder or hypermobile Ehlers-Danlos syndrome and long-lasting shoulder complaints: study protocol for the Shoulder-MOBILEX study
Behnam Liaghat, Søren T. Skou, Jens Søndergaard, Eleanor Boyle, Karen Søgaard, Birgit Juul-Kristensen
Correction to: One Plus One Equals Two—will that do? A trial protocol for a Swedish multicentre randomised controlled trial to evaluate a clinical practice to reduce severe perineal trauma
M. Edqvist, H. G. Dahlen, C. Häggsgård, H. Tern, K. Ängeby, G. Tegerstedt, P. Teleman, G. Ajne, C. Rubertsson
Helmet continuous positive airway pressure versus high-flow nasal cannula in COVID-19: a pragmatic randomised clinical trial (COVID HELMET)
Jonas Tverring, Anna Åkesson, Niklas Nielsen
The effectiveness of battlefield acupuncture in addition to standard physical therapy treatment after shoulder surgery: a protocol for a randomized clinical trial
Michael S. Crowell, Richard A. Brindle, John S. Mason, Will Pitt, Erin M. Miller, Matthew A. Posner, Kenneth L. Cameron, Donald L. Goss
The effect of propolis supplementation on clinical symptoms in patients with coronavirus (COVID-19): A structured summary of a study protocol for a randomised controlled trial
Mahsa Miryan, Davood Soleimani, Leila Dehghani, Karim Sohrabi, Farzin Khorvash, Mohammad Bagherniya, Sayed Mazaher Sayedi, Gholamreza Askari
Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership’s home visiting program in South Carolina on maternal and child health outcomes
Margaret A. McConnell, R. Annetta Zhou, Michelle W. Martin, Rebecca A. Gourevitch, Maria Steenland, Mary Ann Bates, Chloe Zera, Michele Hacker, Alyna Chien, Katherine Baicker
Postoperative analgesic effect of acupotomy combined with patient-controlled analgesia in patients undergoing video-assisted thoracoscopic surgery: a study protocol for a randomized controlled trial
Cai Jiang, Yinyan Li, Xiaomei Li, Jinhua Guo, Miaomiao Guo, Shengxian Yu, Zhonghua Lin
Safety and Efficacy of Ixekizumab and Antiviral Treatment for Patients with COVID-19: A structured summary of a study protocol for a Pilot Randomized Controlled Trial
Panpan Liu, Zhijun Huang, Mingzhu Yin, Chun Liu, Xiang Chen, Pinhua Pan, Yehong Kuang
A systematic review of the “promising zone” design
Julia M. Edwards, Stephen J. Walters, Cornelia Kunz, Steven A. Julious
Mentalization for Offending Adult Males (MOAM): study protocol for a randomized controlled trial to evaluate mentalization-based treatment for antisocial personality disorder in male offenders on community probation
Peter Fonagy, Jessica Yakeley, Tessa Gardner, Elizabeth Simes, Mary McMurran, Paul Moran, Mike Crawford, Alison Frater, Barbara Barrett, Angus Cameron, James Wason, Stephen Pilling, Stephen Butler, Anthony Bateman
Randomized controlled multicentre study of albumin replacement therapy in septic shock (ARISS): protocol for a randomized controlled trial
Yasser Sakr, Michael Bauer, Axel Nierhaus, Stefan Kluge, Ulricke Schumacher, Christian Putensen, Falk Fichtner, Sirak Petros, Christian Scheer, Ulrich Jaschinski, Ivan Tanev, David Jacob, Norbert Weiler, P. Christian Schulze, Fritz Fiedler, Barbara Kapfer, Frank Brunkhorst, Ingmar Lautenschlaeger, Katja Wartenberg, Stefan Utzolino, Josef Briegel, Onnen Moerer, Petra Bischoff, Alexander Zarbock, Michael Quintel, Luciano Gattinoni, C. Schulze, J. G. Westphal, R. Pfeifer, M. Frizenwanger, F. Fichtner, P. Simon, S. Rasche, S. Schering, S. Petros, L. Weidhase, B. Pasieka, P. Appelt, K. Wartenberg, Dominik Michalski, A. Nierhaus, D. Jarczak, S. Kluge, A. Zarbock, M. Meersch, N. Weiler, I. Lautenschläger, G. Elke, T. Becher, M. Kott, F. Roghmann, M. Senkal, U. Hermann Frey, P. Bischof, U. Jaschinski, P. Deetjen, O. Mörer, M. Quintel, L. Gattinoni, J. Briegel, M. Rehm, B. Kapfer, J. Martin, S. Utzolino, L. Kousoulas, C. Scheer, S. O. Kuhn, J. Lehmke, J. Ebbinghaus, I. Tanev, A. Schmeisser, M. Holubek, J. Handerer, D. Jacob, U. Lodes, A. Weyland, U. Günther, C. Putensen, C. Weissbrich, J. C. Schewe, S. Ehrentraut, F. Fiedler, P. Tepaß
Effect of acupuncture for methadone maintenance treatment patients: study protocol of a randomized clinical trial
Hao Wen, Shichao Xu, Jingchun Zeng, Shuqi Ge, Yuan Liao, Chunzhi Tang, Songhua Xiao, Liming Lu
Correction to: IMPROVEjob – Participatory intervention to improve job satisfaction of general practice teams: a model for structural and behavioural prevention in small and medium-sized enterprises – a study protocol of a cluster-randomised controlled trial
Birgitta M. Weltermann, Christine Kersting, Claudia Pieper, Tanja Seifried-Dübon, Annegret Dreher, Karen Linden, Esther Rind, Claudia Ose, Karl-Heinz Jöckel, Florian Junne, Brigitte Werners, Verena Schroeder, Jean-Marie Bois, Achim Siegel, Anika Thielmann, Monika A. Rieger, Stefanie Kasten, M. A. Rieger, E. Rind, A. Siegel, A. Wagner, E. Tsarouha, B. Weltermann, S. Kasten, K. Linden, L. Degen, A. Thielmann, F. Junne, T. Seifried-Dübon, A. Hermann-Werners, F. Stuber, S. Zipfel, B. Werners, M. Grot, K-H Jöckel, C. Pieper, V. Schröder, J-M Bois, A-L Eilerts, M. Brinkmann, C. Kersting, S. Emerich, S. Burgess, M. Hippler, A. Dreher, C. Ose, L. Koppka, J. Block
A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19: the DAWn-Antico study
T. Vanassche, M. M. Engelen, Q. Van Thillo, J. Wauters, J. Gunst, C. Wouters, C. Vandenbriele, S. Rex, L. Liesenborghs, A. Wilmer, P. Meersseman, G. Van den Berghe, D. Dauwe, G. Verbeke, M. Thomeer, T. Fivez, D. Mesotten, D. Ruttens, L. Heytens, I. Dapper, S. Tuyls, B. De Tavernier, P. Verhamme, Iwein Gyselinck, Laure-Anne Teuwen, Vincent Geldhof, Ewout Landeloos, Tatjana Geukens, Helga Ceunen, Barbara Debaveye, Caroline Devooght, Anna Ockerman, Veerle Servaes, Ann Belmans
Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial
Katherine T. O’Donnell, Melanie Dunbar, Diana L. Speelman
Effects of football versus aerobic exercise training on muscle architecture in healthy men adults: a study protocol of a two-armed randomized controlled trial
Guevar Alkhateeb, Lars Donath
Assessing the effect of an evidence-based patient online educational tool for people with multiple sclerosis called UMIMS—understanding magnetic resonance imaging in multiple sclerosis: study protocol for a double-blind, randomized controlled trial
Insa Schiffmann, Magalie Freund, Eik Vettorazzi, Jan-Patrick Stellmann, Susanne Heyer-Borchelt, Marie D’Hooghe, Vivien Häußler, Anne Christin Rahn, Christoph Heesen
Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis
Shivani N. Mehta, Chrysovalantis Stafylis, David M. Tellalian, Pamela L. Burian, Cliff M. Okada, Carl E. Millner, Christopher M. Mejia, Jeffrey D. Klausner
An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial
Kathryn A. Radford, Kristelle Craven, Vicki McLellan, Tracey H. Sach, Richard Brindle, Ivana Holloway, Suzanne Hartley, Audrey Bowen, Rory O’Connor, Judith Stevens, Julie Philips, Marion Walker, Jain Holmes, Christopher McKevitt, John Murray, Caroline Watkins, Katie Powers, Angela Shone, Amanda Farrin
Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people
Charlotte L. Hall, Charlotte Sanderson, Beverly J. Brown, Per Andrén, Sophie Bennett, Liam R. Chamberlain, E. Bethan Davies, Kareem Khan, Natalie Kouzoupi, David Mataix-Cols, Caitlin McKenzie, Tara Murphy, Mark Townsend, Chris Hollis, Elizabeth Murray
Improving mental health care for unaccompanied young refugees through a stepped-care approach versus usual care+: study protocol of a cluster randomized controlled hybrid effectiveness implementation trial
Rita Rosner, Cedric Sachser, Fabienne Hornfeck, Reinhold Kilian, Heinz Kindler, Rainer Muche, Lauritz Rudolf Floribert Müller, Jonathan Thielemann, Tamara Waldmann, Ute Ziegenhain, Johanna Unterhitzenberger, Elisa Pfeiffer
Effect of duloxetine premedication for postherpetic neuralgia within 72 h of herpes zoster reactivation [PROCESS]: a study protocol for a randomized controlled trial
Zheng Chen, Niti Shrestha, Chunmei Zhao, Bifa Fan, Fang Luo
Nebulised surfactant for the treatment of severe COVID-19 in adults (COV-Surf): A structured summary of a study protocol for a randomized controlled trial
Ahilanandan Dushianthan, Howard Clark, Jens Madsen, Robin Mogg, Lewis Matthews, Lee Berry, Jorge Bernardino de la Serna, James Batchelor, David Brealey, Tracy Hussell, Joanna Porter, Ratko Djukanovic, Martin Feelisch, Anthony Postle, Michael P. W. Grocott
Measles-mumps-rubella vaccine at 6 months of age, immunology, and childhood morbidity in a high-income setting: study protocol for a randomized controlled trial
Dorthe Maria Vittrup, Anne Cathrine Lund Laursen, Michelle Malon, Jesper Kiehn Soerensen, Jakob Hjort, Soren Buus, Jannet Svensson, Lone Graff Stensballe
A pilot protocol to assess the feasibility of a virtual multiple crossover, randomized controlled trial design using methylphenidate in mild cognitive impairment
DesRuisseaux Libby A., Victoria J. Williams, Alison J. McManus, Anoopum S. Gupta, Becky C. Carlyle, Hamed Azami, Jessica A. Gerber, Anna M. Bolling, Carolyn L. Cook, Rebecca A. Betensky, Steven E. Arnold
Developing a core outcome set for the treatment of pregnant women with pregestational diabetes—a study protocol
Oratile Kgosidialwa, Delia Bogdanet, Aoife Egan, Paula M. O’Shea, Linda Biesty, Declan Devane, Fidelma Dunne
Vitamin D for prevention of sternotomy healing complications: REINFORCE-D trial
Michal Čečrle, Dalibor Černý, Eva Sedláčková, Barbora Míková, Vlasta Dudková, Eva Drncová, Michala Pokusová, Ivo Skalský, Jana Tamášová, Milada Halačová
Death Cafés for prevention of burnout in intensive care unit employees: study protocol for a randomized controlled trial (STOPTHEBURN)
Marjorie E. Bateman, Rachel Hammer, Abigail Byrne, Nithya Ravindran, Jennifer Chiurco, Sasha Lasky, Rebecca Denson, Margo Brown, Leann Myers, Yuanhao Zu, Joshua L. Denson
Quantitative response of healthy muscle following the induction of capsaicin: an exploratory randomized controlled trial
Valerie Evans, Michael Behr, Kei Masani, Dinesh Kumbhare
Strategy for addressing research-site overlap in pragmatic clinical trials: lessons learned from the NIH-DOD-VA Pain Management Collaboratory (PMC)
Mary Geda, Steven Z. George, Diana J. Burgess, Dylan V. Scarton, William T. Roddy, Kirsha S. Gordon, Paul F. Pasquina, Cynthia A. Brandt, Robert D. Kerns, Peter Peduzzi
Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China
Xiaopei Chao, Lei Li, Ming Wu, Huanwen Wu, Shuiqing Ma, Xianjie Tan, Sen Zhong, Jinghe Lang
Efficacy of a web application for stress management among Iranian college students during COVID-19 outbreak: a study protocol for randomized controlled trials
Fatemeh Khademian, Azam Aslani, Ramin Ravangard, Peivand Bastani, Mohammad Nami, Peyman Jafari
Correction to: A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial
Timothy Devos, Tatjana Geukens, Alexander Schauwvlieghe, Kevin K. Ariën, Cyril Barbezange, Myriam Cleeren, Veerle Compernolle, Nicolas Dauby, Daniël Desmecht, David Grimaldi, Bart N. Lambrecht, Anne Luyten, Piet Maes, Michel Moutschen, Marta Romano, Lucie Seyler, Michel Toungouz Nevessignsky, Katleen Vandenberghe, Johan van Griensven, Geert Verbeke, Erika Vlieghe, Jean Cyr Yombi, Laurens Liesenborghs, Peter Verhamme, Geert Meyfroidt
An entertainment-education approach to prevent COVID-19 spread: study protocol for a multi-site randomized controlled trial
Alain Vandormael, Maya Adam, Merlin Greuel, Till Bärnighausen
Correction to: A collaborative care psychosocial intervention to improve late life depression in socioeconomically deprived areas of Guarulhos, Brazil: the PROACTIVE cluster randomised controlled trial protocol
Marcia Scazufca, Carina Akemi Nakamura, Tim J. Peters, Maiara Garcia Henrique, Antônio Seabra, Ehidee Gomez La Rotta, Renato M. Franzin, Daniele Ferreira Martins, Pepijn Van de Ven, William Hollingworth, Ricardo Araya
Effects of curcumin-piperine co-supplementation on clinical signs, duration, severity, and inflammatory factors in patients with COVID-19: a structured summary of a study protocol for a randomised controlled trial
Mahsa Miryan, Mohammad Bagherniya, Amirhossein Sahebkar, Davood Soleimani, Mohammad Hossein Rouhani, Bijan Iraj, Gholamreza Askari
Advantages of visualisations to evaluate and communicate adverse event information in randomised controlled trials
Victoria Cornelius, Suzie Cro, Rachel Phillips
Efficacy of Traditional Chinese Medicine, Maxingshigan-Weijing in the management of COVID-19 patients with severe acute respiratory syndrome: A structured summary of a study protocol for a randomized controlled trial
Congcong Zeng, Zhengzhong Yuan, Xiaoqiong Pan, Jizhou Zhang, Jiahui Zhu, Fan Zhou, Zhuocheng Shan, Ye Yuan, Ren Ye, Jinguo Cheng
Correction to: The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial
Aron Onerup, Eva Angenete, David Bock, Mats Börjesson, Monika Fagevik Olsén, Elin Grybäck Gillheimer, Stefan Skullman, Sven-Egron Thörn, Eva Haglind, Hanna Nilsson
COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for a randomized controlled trial
Cédric Annweiler, Mélinda Beaudenon, Jennifer Gautier, Romain Simon, Vincent Dubée, Justine Gonsard, Elsa Parot-Schinkel, Amal Aidoud, Guillaume Albaret, Cédric Annweiler, Alexandra Audemard-Verger, Marine Asfar, Jean Barré, Florian Berteau, Gaëlle Bertoletti, Jean-Baptiste Beuscart, Adrien Bigot, Sophie Boucher, Elisabeth Botelho-Nevers, Isabelle Bourdel-Marchasson, Anne Sophie Boureau, Antoine Brangier, Céline Brouessard, Marie Laure Bureau, Noëlle Cardinaud, Michel Carles, Karine Castro-Lionard, Thomas Celarier, Guillaume Chapelet, David Chirio, Emilie Clabé, Philippe Codron, Johan Courjon, Éric Cua, Marie Danet-Lamasou, Alexiane Decorbez, Marine De La Chapelle, Elisa Demonchy, Edouard Desvaux, Monique D’Hautefeuille, Vincent Dubée, Guillaume Duval, Bertrand Fougère, Paul Gassie, Nicolas Giroult, Olivier Guérin, Régis Hankard, Marjorie Houvet, Stéphanie Jobard, Carole Lacout, Aurélie Lafargue, Cécile Laubarie-Mouret, Maxime Le Floch, Sylvain Le Gentil, Sébastien Lléonart, Jocelyne Loison, Rafaël Mahieu, François Maillot, Laure Martinez, Marie Mathieu, Anthony Mauclere, Pierre Ménager, Emeline Michel, Thai Binh Nguyen, Romain Ordonez, Marie Otekpo, Virginie Pichon, Fanny Poitau, Gary Pommier, Valérie Rabier, Karine Risso, Hélène Rivière, Agnès Rouaud, Claire Roubaud-Baudron, Guillaume Sacco, Frédéric Scholastique, Etienne Seronie-Doutriaux, Achille Tchalla, Wojciech Trzepizur, Yves-Marie Vandamme
Effect of a probiotic on blood pressure in grade 1 hypertension (HYPRO): protocol of a randomized controlled study
Anja Mähler, Nicola Wilck, Geraldine Rauch, Ralf Dechend, Dominik N. Müller
Correction to: A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19: the DAWn-Antico study
T. Vanassche, M. M. Engelen, Q. Van Thillo, J. Wauters, J. Gunst, C. Wouters, C. Vandenbriele, S. Rex, L. Liesenborghs, A. Wilmer, P. Meersseman, G. Van den Berghe, D. Dauwe, G. Verbeke, M. Thomeer, T. Fivez, D. Mesotten, D. Ruttens, L. Heytens, I. Dapper, S. Tuyls, B. De Tavernier, P. Verhamme