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Advances in Alzheimer’s

Keynote webinar | Spotlight on modern management of frailty

LIVE: Thursday 17th October 2024, 18:00-19:30 (CEST)

Frailty has a significant impact on health and wellbeing, especially in older adults. Join our experts to understand the factors that contribute to the development of frailty and find out how to manage the condition and reduce the risk of disability, dependency, and mortality.
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Trials

Issue 1/2023

Content (823 Articles)

Effects of Qingda granule on patients with grade 1 hypertension at low-medium risk: study protocol for a randomized, controlled, double-blind clinical trial

Lin-zi Long, Jian-feng Chu, Hua Qu, Qiao-ning Yang, Yan Lu, Chang-geng Fu, Jun Peng, Ke-ji Chen

Two-center randomized controlled trial comparing oral chloral hydrate and intranasal combination of dexmedetomidine and ketamine for procedural sedation in children: study protocol

Young-Eun Jang, Eun-Young Joo, Ji-Hyun Lee, Eun-Hee Kim, Pyoyoon Kang, Jung-Bin Park, Hee-Soo Kim, Jin-Tae Kim

  • Open Access
  • Research

The effects of adjunctive treatment with l-carnitine on monitoring laboratory variables in ICU patients: a double-blinded randomized controlled clinical trial

Farveh Yahyapoor, Mahdi Keshani, Alireza Sedaghat, Awat Feizi, Cain C. T. Clark, Mohammad Bagherniya, Mohammad Safarian, Mohaddeseh Badpeyma, Abdolreza Norouzy

Safety of AFM11 in the treatment of patients with B-cell malignancies: findings from two phase 1 studies

Max Topp, Monika Dlugosz-Danecka, Aleksander B. Skotnicki, Galina Salogub, Andreas Viardot, Andreas K. Klein, Georg Hess, Christian S. Michel, Sebastian Grosicki, Alex Gural, Sylvia E. Schwarz, Kerstin Pietzko, Ulrike Gärtner, András Strassz, Leila Alland, Jiri Mayer

  • Open Access
  • Malaria
  • Study protocol

Testing the effects of mass drug administration of azithromycin on mortality and other outcomes among 1–11-month-old infants in Mali (LAKANA): study protocol for a cluster-randomized, placebo-controlled, double-blinded, parallel-group, three-arm clinical trial

Laura Adubra, Dagmar Alber, Per Ashorn, Ulla Ashorn, Yin Bun Cheung, Elaine Cloutman-Green, Fatoumata Diallo, Camilla Ducker, Riku Elovainio, Yue-Mei Fan, Lily Gates, Gwydion Gruffudd, Tiia Haapaniemi, Fadima Haidara, Lotta Hallamaa, Rikhard Ihamuotila, Nigel Klein, Juho Luoma, Owen Martell, Samba Sow, Taru Vehmasto

Efficacy and safety of GLucocorticoid injections into InfrapaTellar faT pad in patients with knee ostEoarthRitiS: protocol for the GLITTERS randomized controlled trial

Yan Zhang, Guangfeng Ruan, Peng Zheng, Sili Huang, Xiaoni Zhou, Xuelian Liu, Wenjie Hu, Huiting Feng, Yangyang Lin, Juanjuan He, Zhenhai Wei, Jiangshan Zhang, Qing Chang, Xiaomei Wei, Tao Fan, Li Jiang, Changhai Ding

  • Open Access
  • Study Protocol

Family wellbeing in general practice: a study protocol for a cluster-randomised trial of the web-based resilience programme on early child development

Gritt Overbeck, Jakob Kragstrup, Mette Gørtz, Ida Scheel Rasmussen, Anette Hauskov Graungaard, Volkert Siersma, Sarah de Voss, Ruth Kirk Ertmann, Sinead Shahrzad, Clara Lundmark Appel, Philip Wilson

  • Open Access
  • Obesity
  • Study protocol

Randomized controlled trial evaluating a virtual parenting intervention for young children at risk of obesity: study protocol for Parenting Addressing Early Years Intervention with Coaching Visits in Toronto (PARENT) trial

Sarah Rae, Jonathon Maguire, Mary Aglipay, Melanie Barwick, Karoon Danavan, Jess Haines, Jennifer Jenkins, Marie Klaassen, Myla E. Moretti, Frank Ong, Nav Persaud, Michelle Porepa, Sharon Straus, Erika Tavares, Andrew Willan, Catherine Birken

A cluster-randomized, placebo-controlled trial to evaluate the efficacy of a spatial repellent (Mosquito Shield™) against Aedes-borne virus infection among children ≥ 4–16 years of age in the Gampaha District, Sri Lanka: study protocol (the AEGIS program)

Hasitha Tissera, D. S. Anoja F. Dheerasinghe, Neelika Malavige, H. Asita de Silva, Amy C. Morrison, Thomas W. Scott, Robert C. Reiner Jr, John P. Grieco, Nicole L. Achee

  • Open Access
  • Research

Common Clinical Trial Amendments, why they are submitted and how they can be avoided: a mixed methods study on NHS UK Sponsored Research (Amendments Assemble)

Shivam Joshi

Randomized control trial of prednisolone and doxycycline in patients with acute interstitial nephritis of unknown aetiology

Zeid Badurdeen, Neelakanthi Ratnatunga, Tilak Abeysekera, Abdul. W. M. Wazil, Premil N. Rajakrishna, Jalitha P. Thinnarachchi, Dulani D. Welagedera, Nadeeka Ratnayake, Adambarage. P. D. Alwis, Hemalika Abeysundara, Ranjith Kumarasiri, Richard Taylor, Nishantha Nanayakkara

Comparison of high-flow nasal cannula and conventional oxygen therapy for high-risk patients during bronchoscopy examination: protocol for a randomized controlled trial

Hao Qin, Guo-Qiang Jing, Wei Tan, Jun Wang, Yi-Nan Yin, Rong-Zhang Chen, Wei Zhang, Jie Li

Esketamine-based opioid-free anaesthesia alleviates postoperative nausea and vomiting in patients who underwent laparoscopic surgery: study protocol for a randomized, double-blinded, multicentre trial

Hai-yan Chen, Xiao-yan Meng, Hao Gao, Hui Liu, Hai-Bo Qiu, Jun Lu, Jin-Chao Song

  • Open Access
  • Methodology

A comparison of covariate adjustment approaches under model misspecification in individually randomized trials

Mia S. Tackney, Tim Morris, Ian White, Clemence Leyrat, Karla Diaz-Ordaz, Elizabeth Williamson

The CALM trial protocol: a randomised controlled trial of a guided self-help cognitive behavioural therapy intervention to reduce dental anxiety in children

Zoe Marshman, Helen Rodd, Caroline Fairhurst, Jenny Porritt, Bhupinder Dawett, Peter Day, Nicola Innes, Christopher Vernazza, Tim Newton, Sarah Ronaldson, Liz Cross, Jennie Ross, Sarah R. Baker, Catherine Hewitt, David Torgerson, Hannah Ainsworth

Improving patient-centered communication in breast cancer: a study protocol for a multilevel intervention of a shared treatment deliberation system (SharES) within the NCI community oncology research program (NCORP) (Alliance A231901CD)

Sarah T. Hawley, Kelley Kidwell, David Zahrieh, Anne McCarthy, Rachel Wills, Aaron Rankin, Timothy Hofer, Selina Chow, Reshma Jagsi, Heather Neuman

  • Open Access
  • Care
  • Study protocol

On Top of Everything: a study protocol for a cluster-randomised controlled trial testing a teacher training programme to teach mindfulness among students in Danish upper secondary schools and schools of health and social care

Michelle Sand Beck, Lise Juul, Morten Frydenberg, Lone Overby Fjorback

Implementation of an evidence-based management algorithm for patients with chronic pancreatitis (COMBO trial): study protocol for a stepped-wedge cluster-randomized controlled trial

Florence E. M. de Rijk, Charlotte L. van Veldhuisen, Marc G. Besselink, Jeanin E. van Hooft, Hjalmar C. van Santvoort, Erwin J. M. van Geenen, Cornelis H. van Werkhoven, Pieter Jan F. de Jonge, Marco J. Bruno, Robert C. Verdonk

Routine administration of neostigmine after recovery of spontaneous breathing versus neuromuscular monitor-guided administration of neostigmine in pediatric patients: a parallel, randomized, controlled study

Lei Yang, Na Hu, Hong Chang, Di Yang, Yunxia Zuo

TRansfusion strategies in Acute brain INjured patients (TRAIN): a prospective multicenter randomized interventional trial protocol

Fabio Silvio Taccone, Rafael Badenes, Carla Bittencourt Rynkowski, Pierre Bouzat, Anselmo Caricato, Pedro Kurtz, Kirsten Moller, Manuel Quintana Diaz, Mathieu Van Der Jagt, Walter Videtta, Jean-Louis Vincent

  • Open Access
  • Care
  • Update

Pragmatic cluster randomized trial to evaluate effectiveness and implementation of EHR-facilitated collaborative symptom control in cancer (E2C2): addendum

Jeph Herrin, Lila J. Finney Rutten, Kathryn J. Ruddy, Kurt Kroenke, Andrea L. Cheville

The effect of guselkumab on inhibiting radiographic progression in patients with active psoriatic arthritis: study protocol for APEX, a Phase 3b, multicenter, randomized, double-blind, placebo-controlled trial

Christopher T. Ritchlin, Laura C. Coates, Philip J. Mease, Désirée van der Heijde, Jiao Song, Yusang Jiang, May Shawi, Alexa P. Kollmeier, Proton Rahman

Periradicular repair after single- and two-visit root canal treatments using ultrasonic irrigant activation and calcium hydroxide dressing of teeth with apical periodontitis: study protocol for randomized controlled trials

Gustavo M. Almeida, Vitor Hugo M. Carvalho, Érika B. P. Silva, Marco Antonio F. Cançado, Leonardo S. Barroso, Erica L. Queiroz, Tien Li An, Ana Paula D. Ribeiro, Jacy R. Carvalho-Junior, André F. Leite

An AI-based patient-specific clinical decision support system for OA patients choosing surgery or not: study protocol for a single-centre, parallel-group, non-inferiority randomised controlled trial

Nanna Kastrup, Helene H. Bjerregaard, Mogens Laursen, Jan B. Valentin, Søren P. Johnsen, Cathrine E. Jensen

Intervention for Sleep and Pain in Youth (ISPY-RCT): protocol for a two-phase randomized controlled trial of sequenced cognitive-behavioral therapy for insomnia and pain management in adolescents with migraine

Emily F. Law, Lee Ritterband, Chuan Zhou, Tonya M. Palermo

Effect of cognitive behavior therapy (CBT) on lowering of blood glucose levels in gestational diabetes mellitus (GDM) patients: study protocol for a prospective, open-label, randomized controlled trial

Ying Pan, Hong-ying Liu, Shao Zhong

Knowledge mobilization activities to support decision-making by youth, parents, and adults using a systematic and living map of evidence and recommendations on COVID-19: protocol for three randomized controlled trials and qualitative user-experience studies

Rana Charide, Lisa Stallwood, Matthew Munan, Shahab Sayfi, Lisa Hartling, Nancy J. Butcher, Martin Offringa, Sarah Elliott, Dawn P. Richards, Joseph L. Mathew, Elie A. Akl, Tamara Kredo, Lawrence Mbuagbaw, Ashley Motillal, Ami Baba, Matthew Prebeg, Jacqueline Relihan, Shannon D. Scott, Jozef Suvada, Maicon Falavigna, Miloslav Klugar, Tamara Lotfi, Adrienne Stevens, Kevin Pottie, Holger J. Schünemann

Correction: Acupuncture for the treatment of diarrheal-predominant irritable bowel syndrome: study protocol for a pilot randomized controlled trial

Ling-Yu Qi, Yu Wang, Li-Qiong Wang, Yan-Fen She, Guang-Xia Shi, Ying Li, Li-Li Chi, Bang-Qi Wu, Jian-Feng Tu, Ying Lin, Fang-Ting Yu, Jing-Wen Yang, Cun-Zhi Liu

Statistical analysis plan for the motor neuron disease systematic multi-arm adaptive randomised trial (MND-SMART)

Richard A. Parker, Christopher J. Weir, Tra My Pham, Ian R. White, Nigel Stallard, Mahesh K. B. Parmar, Robert J. Swingler, Rachel S. Dakin, Suvankar Pal, Siddharthan Chandran

Comparison of the effect of modified intermittent fasting and daily calorie restriction on sleep quality, anthropometric data, and body composition in women with obesity or overweight: study protocol of a randomized controlled trial

Saeedeh Hosseini Hooshiar, Akram Yazdani, Sadegh Jafarnejad

  • Open Access
  • Ileus
  • Study protocol

Rectal stimulation with prebiotics and probiotics before ileostomy reversal: a study protocol for a randomized controlled trial

Marília Marcelino, Francisco Tustumi, Lucas Soares Gerbasi, Rafael Vaz Pandini, Rafaela de Souza Novo, Marleny Novaes Figueiredo de Araujo, Elis Oliveira, Victor Edmond Seid, Sergio Eduardo Alonso Araujo

  • Open Access
  • Care
  • Study protocol

A Sequential Multiple Assignment Randomized Trial of scalable interventions for ART delivery in South Africa: the SMART ART study

Alastair van Heerden, Adam Szpiro, Xolani Ntinga, Connie Celum, Heidi van Rooyen, Zaynab Essack, Ruanne Barnabas

The impact of different researchers to capture quality of life measures in a dementia randomised controlled trial

Rachel Evans, Paul Brocklehurst, Jean Ryan, Zoë Hoare

  • Open Access
  • Commentary

Minimum important difference is minimally important in sample size calculations

Hubert Wong

The effect of bitter almond (Amygdalus communis L. var. Amara) gum as a functional food on metabolic profile, inflammatory markers, and mental health in type 2 diabetes women: a blinded randomized controlled trial protocol

Saba Saati, Parvin Dehghan, Fatemeh Azizi-Soleiman, Majid Mobasseri

Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava

Chengguo Xing, John Malaty, Melissa Bou Malham, Anna Maria Abi Nehme, Breanne Freeman, Zhiguang Huo, Roberto Firpi-Morrel, Ramzi G. Salloum

Restoring Study PRGF: a randomized clinical trial on plasma rich in growth factors for knee osteoarthritis

Luis Carlos Saiz, Juan Erviti, Leire Leache, Marta Gutiérrez-Valencia

Phlebotomy resulting in controlled hypovolemia to prevent blood loss in major hepatic resections (PRICE-2): study protocol for a phase 3 randomized controlled trial

Guillaume Martel, Tori Lenet, Christopher Wherrett, François-Martin Carrier, Leah Monette, Aklile Workneh, Karine Brousseau, Monique Ruel, Michaël Chassé, Yves Collin, Franck Vandenbroucke-Menu, Élodie Hamel-Perreault, Michel-Antoine Perreault, Jeieung Park, Shirley Lim, Véronique Maltais, Philemon Leung, Richard W. D. Gilbert, Maja Segedi, Jad Abou-Khalil, Kimberly A. Bertens, Fady K. Balaa, Tim Ramsay, Dean A. Fergusson

Effects of physical training on functional, clinical, morphological, behavioural and psychosocial outcomes in post-COVID-19 infection: COVID-19 and REhabilitation study (CORE-study)—a study protocol for a randomised controlled clinical trial

Rodrigo Sudatti Delevatti, Angelica Danielevicz, Maria Eduarda Sirydakis, Paulo Urubatan Gama de Melo, Cíntia de la Rocha Freitas, Cassiano Ricardo Rech, Luiz Guilherme Antonacci Guglielmo, Guilherme Fleury Fina Speretta, Fernanda Hansen, Fernanda Rodrigues Fonseca, Ana Carolina Starke, Ricardo Dantas de Lucas, José Tavares de Melo Junior, Rosemeri Maurici, Aline Mendes Gerage

Effect of high-frequency repetitive transcranial magnetic stimulation under different intensities upon rehabilitation of chronic pelvic pain syndrome: protocol for a randomized controlled trial

Mengyang Wang, Rui Xia, Jiao Shi, Chunhua Yang, Yongqing Zhang, Zhengxian Xu, Cancan Yu, Ziyi Wu, Min Wang, Shangjie Chen, Hongdang Qu

  • Open Access
  • Study protocol

CANOPTIPHYS study protocol: Optimising PHYSical function before CANcer surgery: effects of pre-operative optimisation on complications and physical function after gastrointestinal cancer surgery in older people at risk—a multicentre, randomised, parallel-group study

Mikael Andersson, Monika Egenvall, Johanna Danielsson, Anders Thorell, Christian Sturesson, Mattias Soop, Malin Nygren-Bonnier, Elisabeth Rydwik

Telehealth multicomponent exercise and health education in breast cancer patients undergoing primary treatment: rationale and methodological protocol for a randomized clinical trial (ABRACE: Telehealth)

João S. Henkin, Cíntia E. Botton, Mariana S. Simon, Guilherme G. Rocha, Caroline B. Silveira, Ricardo S. Gehrke, Gabriella B. Freitas, Gabriel S. Trajano, Ronei S. Pinto, Stephanie S. Pinto

A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol

Thorsten Barnhofer, Barnaby D. Dunn, Clara Strauss, Florian Ruths, Barbara Barrett, Mary Ryan, Asha Ladwa, Frances Stafford, Roberta Fichera, Hannah Baber, Ailis McGuinness, Isabella Metcalfe, Delilah Harding, Sarah Walker, Poushali Ganguli, Shelley Rhodes, Allan Young, Fiona Warren

LessStress - how to reduce stress in school: evaluation of a universal stress prevention in schools: study protocol of a cluster-randomised controlled trial

Christin Scheiner, Andrea Daunke, Alexandra Seidel, Sabrina Mittermeier, Marcel Romanos, Michael Kölch, Arne Buerger

Efficacy of self-management program associated with a spa therapy for knee osteoarthritis patients (GETT 2): a research protocol for a randomized trial

A. Goldstein, C. Lanhers, C. Gay, K. Dubourg, L. Grange, C. F. Roques, B. Pereira, E. Coudeyre

Smartphone imaging repository: a novel method for creating a CT image bank

Adrienne N. Dula, Truman J. Milling Jr., S. Claiborne Johnston, Jayson Aydelotte, Gary W. Peil, Alec Robinson, Kaiz Asif, Stephen Pan, Sohan Parekh, Steven Warach

  • Open Access
  • Care
  • Study protocol

Enhancement of the haemostatic effect of platelets in the presence of high normal concentrations of von Willebrand factor for critically ill patients needing platelet transfusion—a protocol for the will-plate randomised controlled trial

Goetz Herrmann, Andrea Blum, Daniel Bolliger, Rita Achermann, Anna Estermann, Caroline Eva Gebhard, Anne Henn, Jan Huber, Jasprit Singh, Atanas Todorov, Tatjana Zehnder, Núria Zellweger, Andreas Buser, Dimitrios A. Tsakiris, Alexa Hollinger, Martin Siegemund

Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial

Christopher P. Dwyer, Alberto Alvarez-Iglesias, Robert Joyce, Timothy J. Counihan, Dympna Casey, Sinéad M. Hynes

The standard versus prolonged dual antiplatelet therapy after the XINSORB bioresorbable scaffold implantation (SPARTA) trial: study protocol for a randomized controlled trial

Yizhe Wu, Jiasheng Yin, Chenguang Li, Wei Zhang, Li Shen, Lei Ge, Juying Qian, Junbo Ge

PROPERTY: study protocol for a randomized, double-blind, multicenter placebo-controlled trial assessing neurotoxicity in patients with metastatic gastrointestinal cancer taking PHYCOCARE® during oxaliplatin-based chemotherapy

Christele Le Gouill-Jaijarat, Yann Péréon, Maxime Leroy, Olivier Lépine, Aymeric Loloum, Claire Peluchon, Christelle Volteau, Anne-Sophie Martineau, Simon Korner, Caroline Perrault, Asmahane Benmaziane, Paul Girot, Caroline Petorin, Clément Perret, Catherine Ligeza-Poisson, Didier Mayeur, Laurent Flet, Anne Chiffoleau, Alexandra Poinas, Jaafar Bennouna

Implementation challenges and lessons learned from the STREAM clinical trial—a survey of trial sites

Leena N. Patel, Meera Gurumurthy, Gay Bronson, Karen Sanders, I. D. Rusen

Update to the study protocol Face Your Fears: Virtual reality-based cognitive behavioral therapy (VR-CBT) versus standard CBT for paranoid ideations in patients with schizophrenia spectrum disorders: a randomized clinical trial

U. N. Jeppesen, A. S. Due, L. Mariegaard, A. Pinkham, M. Vos, W. Veling, M. Nordentoft, L. B. Glenthøj

  • Open Access
  • Research

Determining external randomised pilot trial feasibility in preparation for a definitive trial: a web-based survey of corresponding authors of external pilot trial publications

Katie Mellor, Susan J. Dutton, Sally Hopewell

Isoniazid preventive therapy completion in children under 5 years old who are contacts of tuberculosis cases in Lima, Peru: study protocol for an open-label, cluster-randomized superiority trial

L. Otero, N. Zetola, M. Campos, J. Zunt, A. Bayer, M. Curisinche, T. Ochoa, M. Reyes, V. Vega, P. Van der Stuyft, TR. Sterling

Correction: A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE)

I. W. J. M. van Goor, L. A. Daamen, M. G. Besselink, A. M. E. Bruynzeel, O. R. Busch, G. A. Cirkel, B. Groot Koerkamp, N. Haj Mohammed, H. D. Heerkens, H. W. M. van Laarhoven, G. J. Meijer, J. Nuyttens, H. C. van Santvoort, G. van Tienhoven, H. M. Verkooijen, J. W. Wilmink, I. Q. Molenaar, M. P. W. Intven

Effects of half-dose spiomet treatment in girls with early puberty and accelerated bone maturation: a multicenter, randomized, placebo-controlled study protocol

Judit Bassols, Francis de Zegher, Marta Diaz, Gemma Carreras-Badosa, Cristina Garcia-Beltran, Elsa Puerto-Carranza, Cora Oliver-Vila, Paula Casano, Céline Alicia Franco, Rita Malpique, Abel López-Bermejo, Lourdes Ibáñez

COS-Speech: protocol to develop a core outcome set for dysarthria after stroke for use in clinical practice and research

C. Mitchell, A. Bowen, P. Conroy, B. M. Whelan, S. J. Wallace, A. Dancer, K. Woodward-Nutt, J. J. Kirkham

  • Open Access
  • Review

Mapping the methodological diversity of published drug discontinuation studies—a scoping review of study topics, objectives, and designs

Nina Grede, Katrin Kuss, Ina Staudt, Norbert Donner-Banzhoff, Annika Viniol

  • Open Access
  • Study protocol

Assessing the effectiveness and cost-effectiveness of a solution-focused resource-orientated approach (DIALOG+) to improving the quality of life for people with psychosis in India and Pakistan—a cluster RCT

Victoria Jane Bird, Sana Zehra Sajun, Renata Peppl, Sara Evans-Lacko, Stefan Priebe, Swaran Singh, Lakshmi Venkatraman, Padmavati Ramachandran, Aneeta Pasha, Ashar Malik, Onaiza Qureshi

Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms (CAA) in Kawasaki disease (KD): the KD CAA prevention (KD-CAAP) trial protocol

Despina Eleftheriou, Yolanda Collaco Moraes, Cara Purvis, Molly Pursell, Marta Merida Morillas, Robin Kahn, Maria Mossberg, Filip Kucera, Robert Tulloh, Joseph F. Standing, Veronica Swallow, Rachael McCormack, Jethro Herberg, Michael Levin, Mandy Wan, Nigel Klein, Roisin Connon, Ann Sarah Walker, Paul Brogan

The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): protocol for a randomised parallel group controlled trial on behalf of the PHOSP consortium

Enya Daynes, Molly Baldwin, Neil J. Greening, Thomas Yates, Nicolette C. Bishop, George Mills, Matthew Roberts, Malik Hamrouni, Tatiana Plekhanova, Ioannis Vogiatzis, Carlos Echevarria, Rashmita Nathu, Hamish J. C. McAuley, Lorna Latimer, Jennifer Glennie, Francesca Chambers, Ruth Penfold, Emily Hume, Dimitrios Megaritis, Charikleia Alexiou, Sebastian Potthoff, Mitchell James Hogg, Catherine Haighton, Bethany Nichol, Olivia C. Leavy, Matthew Richardson, Omer Elneima, Amisha Singapuri, Marco Sereno, Ruth M. Saunders, Victoria C. Harris, Claire M. Nolan, Charlotte Bolton, Linzy Houchen-Wolloff, Ewen M. Harrison, Nazir Lone, Jennifer Quint, James D. Chalmers, Ling-Pei Ho, Alex Horsley, Michael Marks, Krisnah Poinasamy, Betty Ramen, Louise V. Wain, Christopher Brightling, William D.-C. Man, Rachael Evans, Sally J. Singh

  • Open Access
  • Study protocol

Effect of dexmedetomidine on postoperative cognitive dysfunction in elderly patients undergoing orthopaedic surgery: study protocol for a randomized controlled trial

Weihong Zhao, Huanhuan Zhang, Jianli Li

  • Open Access
  • Care
  • Study protocol

The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Linkage-to-Care Trial: rationale and design of an emergency department-based randomized clinical trial of linkage-to-care strategies for hepatitis C

Sarah E. Rowan, Jason Haukoos, Kevin F. Kamis, Emily Hopkins, Stephanie Gravitz, Carolynn Lyle, Alia A. Al-Tayyib, Edward M. Gardner, James W. Galbraith, Yu-Hsiang Hsieh, Michael S. Lyons, Richard E. Rothman, Douglas A. E. White, Jake R. Morgan, Benjamin P. Linas, Allison L. Sabel, David L. Wyles, Amy Adler, Musheng Alishahi, Gideon D. Avornu, Alexis Becerra, Erika Becerra-Ashby, Meghan Bellamy, Samantha Bot, Alexander J. Boyle, Annetta M. Bracey, Michael Breyer, Claudia Camacho, Alicia Cupelo, Gaby Dashler, Pamela Doyle, Amy Eicher, Heather Gardner, Carrie Anne de Gruiter, Sophia Henry, David Higgins, Trevor Hill, Rachel Houk, Nyah Johnson, Alex Kile, Janet Liebl, Barbara Maliszewski, Kendall Maliszewski, Robert McGoey, Catherine McKenzie, Matthew S. Minturn, Deanna Myer, Kendra Neumann, Cole Ossian, Rebekah K. Peacock, Danielle Perez, Tannishtha Pramanick, Erin P. Ricketts, Benji Riggan, Sherry Riser, Genie Roosevelt, Mustapha Saheed, Sarah Schumacher, Bradley Shy, Scott Simpson, Matthew F. Toerper, Gil Trest, Madison Unsworth, Laura Waltrous, Brooke Watson

Cannabis-opioid interaction in the treatment of fibromyalgia pain: an open-label, proof of concept study with randomization between treatment groups: cannabis, oxycodone or cannabis/oxycodone combination—the SPIRAL study

Cornelis Jan van Dam, Monique van Velzen, Cornelis Kramers, Arnt Schellekens, Erik Olofsen, Marieke Niesters, Albert Dahan

  • Open Access
  • Study protocol

Developing an Outcome Measures in Rheumatology (OMERACT) Core set of Outcome Measures for FOot and ankle disorders in RheumaTic and musculoskeletal diseases (COMFORT): core domain set study protocol

Lara S. Chapman, Anthony C. Redmond, Caroline A. Flurey, Pamela Richards, Toby O. Smith, John B. Arnold, Dorcas Beaton, Philip G. Conaghan, Yvonne M. Golightly, Marian T. Hannan, Catherine Hofstetter, Lara J. Maxwell, Hylton B. Menz, Beverley Shea, Peter Tugwell, Philip Helliwell, Heidi J. Siddle

  • Open Access
  • Review

Paediatric eye and vision research participation experiences: a systematic review

Jacqueline Miller, Katherine Curtis-Tyler, Michelle Maden, Annegret Dahlmann-Noor, Jane Chudleigh

Effect of intubation in the lateral position under general anesthesia induction on the position of double-lumen tube placement in patients undergoing unilateral video-assisted thoracic surgery: study protocol for a prospective, single-center, parallel group, randomized, controlled trial

Xi Zhang, Dong-Xu Wang, Qin Zhang, Qi-Bin Shen, Fei Tong, Yong-He Hu, Zhen-Duo Zhang, Fei-Fan Liu, Ya-Wen Tang, Juan-Li Chen, He Liu, Feng Zhou, Si-Ping Hu

Protocol for a parallel group, two-arm, superiority cluster randomised trial to evaluate a community-level complementary-food safety and hygiene and nutrition intervention in Mali: the MaaCiwara study (version 1.3; 10 November 2022)

Evans A. Asamane, Laura Quinn, Samuel I. Watson, Richard J. Lilford, Karla Hemming, Cheick Sidibe, Ryan T. Rego, Sami Bensassi, Youssouf Diarra, Samba Diop, Om Prasad Gautam, Mohammad Sirajul Islam, Louise Jackson, Kate Jolly, Kassoum Kayentao, Ousmane Koita, Buba Manjang, Susan Tebbs, Nicola Gale, Paula Griffiths, Sandy Cairncross, Ousmane Toure, Semira Manaseki-Holland

Pulmonary rehabilitation integrated coached exercise training for patients with COPD: a study protocol for a randomized controlled trial

Yuting Jing, Yuying Ma, Hongxing Zhang, Zhenhu Wu, Yongwen Li, Haoxuan Li, Minling Huang, Lin Lin, Yinji Xu

  • Open Access
  • Care
  • Study protocol

EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial

R. M. Walker, W. Chaboyer, M. Cooke, J. A. Whitty, L. Thalib, I. Lockwood, S. Latimer, J. Campbell, R. Probert, B. M. Gillespie

  • Open Access
  • Research

Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study

Mais Iflaifel, Kirsty Sprange, Jennifer Bell, Andrew Cook, Carrol Gamble, Steven A. Julious, Edmund Juszczak, Louise Linsell, Alan Montgomery, Christopher Partlett

The efficacy of intraoperatie continuous glucose monitoring in patients undergoing liver transplantation: a study protocol for a prospective randomized controlled superiority trial

Yi Duan, Zuo-Zhi Li, Pan Liu, Lei Cui, Zhifeng Gao, Huan Zhang

Comparative evaluation of the efficacy of customized maxillary oral appliance with mandibular advancement appliance as a treatment modality for moderate obstructive sleep apnea patients—a randomized controlled trial

Vikram Belkhode, Surekha Godbole, Sharayu Nimonkar, Sweta Pisulkar, Pranali Nimonkar

A NEw MOdel of individualized and patient-centered follow-up for women with gynecological cancer (the NEMO study)—protocol and rationale of a randomized clinical trial

Stinne Holm Bergholdt, Dorte Gilsaa Hansen, Anna Thit Johnsen, Bo Snedker Boman, Pernille Tine Jensen

Effectiveness and cost-effectiveness of a personalised self-management intervention for living with long COVID: protocol for the LISTEN randomised controlled trial

Claire Potter, Fiona Leggat, Rachel Lowe, Philip Pallmann, Muhammad Riaz, Christy Barlow, Adrian Edwards, Aloysius Niroshan Siriwardena, Nick Sevdalis, Bernadette Sewell, Jackie McRae, Jessica Fish, Maria Ines de Sousa de Abreu, Fiona Jones, Monica Busse

Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence—a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial)

Sven Müller, Dirk Weyhe, Florian Herrle, Philipp Horvath, Robert Bachmann, Viktor von Ehrlich-Treuenstätt, Patrick Heger, Nadir Nasir, Christina Klose, Alexander Ritz, Anja Sander, Erich Grohmann, Colette Dörr-Harim, André L. Mihaljevic

  • Open Access
  • Study protocol

A pilot randomised controlled trial of the Peer Tree digital intervention targeting loneliness in young people: a study protocol

Michelle H. Lim, Lily Thurston, Robert Eres, Thomas L. Rodebaugh, Mario Alvarez-Jimenez, David L. Penn, Vassilis Kostakos, John F. M. Gleeson

  • Open Access
  • Study protocol

Lateral compression type 1 fracture fixation in the elderly (L1FE): study protocol for a randomised controlled trial (with internal pilot) comparing the effects of INFIX surgery and non-surgical management for treating patients with lateral compression type 1 (LC-1) fragility fractures

Elizabeth Cook, Joanne Laycock, Mehool Acharya, Michael Ross Backhouse, Belen Corbacho, Laura Doherty, Daren Forward, Catherine Hewitt, Catherine Hilton, Peter Hull, Jamila Kassam, Camila Maturana, Catriona Mcdaid, Jenny Roche, Dhanupriya Sivapathasuntharam, David Torgerson, Peter Bates

Randomized double-blind, placebo-controlled study of oral gabapentin for prevention of neuropathy in patients receiving paclitaxel

Praful Pandey, Akash Kumar, Deepam Pushpam, Sachin Khurana, Prabhat Singh Malik, Ajay Gogia, Elavarasi Arunmozhimaran, Mamta Bhushan Singh, Dinu Santha Chandran, Atul Batra

  • Open Access
  • Care
  • Study protocol

A post-market cluster randomized controlled trial of the effect of the TENA SmartCare Change Indicator™ on urinary continence care efficiency and skin health in older nursing home residents

Muyibat Omotunde, Fredrik Agholme, Arne Böhling, Nicole Huige, Hardy Schweigel, Daniela Hayder-Beichel, Robert Reidy, Adrian Wagg

Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial—an update to the published protocol

Christine Norton

  • Open Access
  • Study protocol

Internet-based self-help intervention for procrastination: randomized control group trial protocol

Ying Zhou, Jianhua Wang

The impact of parent treatment preference and other factors on recruitment: lessons learned from a paediatric epilepsy randomised controlled trial

Bernie Carter, Lucy Bray, Nadia al-Najjar, Agnès Tort Piella, Catrin Tudur-Smith, Catherine Spowart, Amber Collingwood, Holly Crudgington, Janet Currier, Dyfrig A. Hughes, Eifiona Wood, Rachael Martin, Christopher Morris, Deborah Roberts, Alison Rouncefield-Swales, Heather Sutherland, Victoria Watson, Georgia Cook, Luci Wiggs, Paul Gringras, Deb Pal

  • Open Access
  • Care
  • Study protocol

Advanced practice physiotherapy care in emergency departments for patients with musculoskeletal disorders: a pragmatic cluster randomized controlled trial and cost analysis

E. Matifat, E. Berger Pelletier, R. Brison, L. J. Hébert, J.-S. Roy, L. Woodhouse, S. Berthelot, R. Daoust, M.-J. Sirois, R. Booth, R. Gagnon, J. Miller, Y. Tousignant-Laflamme, M. Emond, K. Perreault, F. Desmeules

Can multisite clinical trial results change clinical practice? Use of long-acting injectable risperidone nationally in the Veterans Health Administration

Robert Rosenheck, Sonia T. Anand, Stephen G. Kurtz, Cynthia Hau, Diane Smedberg, James F. Pontzer, Ryan E. Ferguson, Cynthia R. Davis

Multidimensional individualized nutritional therapy for individuals with severe chronic obstructive pulmonary disease: study protocol for a registry-based randomized controlled trial

Maria H. Hegelund, Christian Ritz, Thyge L. Nielsen, Mette F. Olsen, Christian Søborg, Lone Braagaard, Christian Mølgaard, Rikke Krogh-Madsen, Birgitte Lindegaard, Daniel Faurholt-Jepsen

The effect of vitamin D and magnesium supplementation on clinical symptoms and serum inflammatory and oxidative stress markers in patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial

Nahid Ramezani-Jolfaie, Ebrahim Eftekhar, Mohadese Dadinasab, Zahra Ghaeini Hesarooeyeh, Pooria Pakdaman, Farkhondeh Razmpour, Gholamali Javedan, Mahmood Khayatian, Mehdi Hassani Azad, Parivash Davoodian, Elham Brahimi, Shideh Rafati, Sara Nikoofal-Sahlabadi, Mohammad Mohammadi

Efficacy and safety of neostigmine on treating gastrointestinal dysmotility in severe acute pancreatitis patients: study protocol for a randomized controlled trial

Han Sun, Yaqi Sheng, Tiekuan Du, Huadong Zhu

  • Open Access
  • Study protocol

The COMFORT trial: a randomised control trial comparing group-based COMpassion-FOcussed therapy and breathing pattern ReTraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID

Sinead Lynch, Damien Lowry, Clodagh Finnerty, Yvonne O’Meara, Donal Brennan

  • Open Access
  • Review

Factors associated with recruitment to randomised controlled trials in general practice: a systematic mixed studies review

Keith R. Moffat, Wen Shi, Paul Cannon, Frank Sullivan

  • Open Access
  • Care
  • Study protocol

Effectiveness of an evidence-based care pathway to improve mobility and participation in older patients with vertigo and balance disorders in primary care (MobilE-PHY2): study protocol for a multicentre cluster-randomised controlled trial

Caren Horstmannshoff, Stefanie Skudlik, Jenny Petermann, Theresia Kiesel, Tobias Döringer, Alexander Crispin, Joachim Hermsdörfer, Juliane Köberlein-Neu, Klaus Jahn, Stefan Schädler, Petra Bauer, Karen Voigt, Martin Müller

  • Open Access
  • Research

“Nothing to lose and the possibility of gaining”: a qualitative study on the feasibility and acceptability of registry-based randomised controlled trials among cancer patients and clinicians

Khic-Houy Prang, Bill Karanatsios, Angela Zhang, Ebony Verbunt, Hui-li Wong, Vanessa Wong, Lucy Gately, Ben Tran, Peter Gibbs, Margaret Kelaher

Patient and Public Involvement (PPI) in outcome selection in breast cancer and nephrology trials

Ciara Buckley, Shaun Treweek, Lynn Laidlaw, Frances Shiely

  • Open Access
  • Nitrate
  • Study protocol

Nitrate-rich beet juice intake on cardiovascular performance in response to exercise in postmenopausal women with arterial hypertension: study protocol for a randomized controlled trial

Cicero Jonas R. Benjamim, Yaritza Brito Alves Sousa, Andrey Alves Porto, Yasmim Mota de Moraes Pontes, Simone Sakagute Tavares, Guilherme da Silva Rodrigues, Leonardo Santos Lopes da Silva, Leonardo da Silva Goncalves, Carolina Scoqui Guimaraes, Macário Arosti Rebelo, Andressa Crystine da Silva Sobrinho, Jose E. Tanus-Santos, Vitor Engracia Valenti, Bruno Gualano, Carlos Roberto Bueno Júnior

  • Open Access
  • Study protocol

The effects of Digital Buddy programme on older adults’ mental well-being: study protocol for a multi-centre, cluster randomized controlled trial

Rick Yiu Cho Kwan, Fowie Ng, Manfred Lai, David Wong, Sally Chan

Project T-SHARP: study protocol for a multi-site randomized controlled trial of tele-harm reduction for people with HIV who inject drugs

Hansel E. Tookes, Asa Oxner, David P. Serota, Elizabeth Alonso, Lisa R. Metsch, Daniel J. Feaster, Jessica Ucha, Edward Suarez Jr., David W. Forrest, Kathryn McCollister, Allan Rodriguez, Michael A. Kolber, Teresa A. Chueng, Sheryl Zayas, Bernice McCoy, Kyle Sutherland, Chetwyn Archer, Tyler S. Bartholomew

The AuTOMATIC trial: a study protocol for a multi-arm Bayesian adaptive randomised controlled trial of text messaging to improve childhood immunisation coverage

Grace E. Currie, James Totterdell, Grahame Bowland, Alan Leeb, Ian Peters, Chris C. Blyth, Claire Waddington, Julie A. Marsh, Thomas L. Snelling

  • Open Access
  • Correction

Correction: The effect of COVID rehabilitation for ongoing symptoms Post HOSPitalisation with COVID-19 (PHOSP-R): protocol for a randomised parallel group controlled trial on behalf of the PHOSP consortium

Enya Daynes, Molly Baldwin, Neil J. Greening, Thomas Yates, Nicolette C. Bishop, George Mills, Matthew Roberts, Malik Hamrouni, Tatiana Plekhanova, Ioannis Vogiatzis, Carlos Echevarria, Rashmita Nathu, Hamish J. C. McAuley, Lorna Latimer, Jennifer Glennie, Francesca Chambers, Ruth Penfold, Emily Hume, Dimitrios Megaritis, Charikleia Alexiou, Sebastian Potthof, Mitchell James Hogg, Catherine Haighton, Bethany Nichol, Olivia C. Leavy, Matthew Richardson, Omer Elneima, Amisha Singapuri, Marco Sereno, Ruth M. Saunders, Victoria C. Harris, Claire M. Nolan, Charlotte Bolton, Linzy Houchen-Wolloff, Ewen M. Harrison, Nazir Lone, Jennifer Quint, James D. Chalmers, Ling-Pei Ho, Alex Horsley, Michael Marks, Krisnah Poinasamy, Betty Ramen, Louise V. Wain, Christopher Brightling, William D.-C. Man, Rachael Evans, Sally J. Singh

Using a patient-centred composite endpoint in a secondary analysis of the Control of Hypertension in Pregnancy Study (CHIPS) Trial

Rebecca K. Metcalfe, Mark Harrison, Joel Singer, Mary Lewisch, Terry Lee, Peter von Dadelszen, Laura A. Magee, Nick Bansback

Biologic Abatement and Capturing Kids’ Outcomes and Flare Frequency in Juvenile Spondyloarthritis (BACK-OFF JSpA): study protocol for a randomized pragmatic trial

Pamela F. Weiss, Cora E. Sears, Timothy G. Brandon, Christopher B. Forrest, Emily Neu, Melanie Kohlheim, Jenny Leal, Rui Xiao, Daniel Lovell

Lisbon Intensive Falls Trampoline Training (LIFTT) Program for people with Parkinson’s for balance, gait, and falls: study protocol for a randomized controlled trial

Josefa Domingos, John Dean, Júlio B. Fernandes, Catarina Ramos, Miguel Grunho, Luís Proença, João R. Vaz, Catarina Godinho

  • Open Access
  • Nausea
  • Study protocol

Quality of recovery after day care surgery with app-controlled remote monitoring: study protocol for a randomized controlled trial

B. Thiel, M. B. Godfried, M. E. van Emst, L. M. Vernooij, L. M. van Vliet, E. Rumke, R. T. M. van Dongen, W. Gerrits, J. S. H. A. Koopman, C. J. Kalkman

  • Open Access
  • Study protocol

An innovative web-based decision-aid about birth after cesarean for shared decision making in Taiwan: study protocol for a randomized control trial

Shu Wen Chen, Allison Shorten, Chang Ching Yeh, Chien Huei Kao, Yu Ying Lu, Hsiang Wei Hu

Efficacy and tolerability of a specific blend of amino acids in patients with anorexia nervosa treated in a hospital setting: study protocol for a randomized controlled trial

Riccardo Dalle Grave, Simona Calugi, Chiara Ruocco, Mirko Chimini, Agnese Segala, Maurizio Ragni, Michele Carruba, Alessandra Valerio, Enzo Nisoli

The Michigan Genetic Hereditary Testing (MiGHT) study’s innovative approaches to promote uptake of clinical genetic testing among cancer patients: a study protocol for a 3-arm randomized controlled trial

Lynette Hammond Gerido, Jennifer J. Griggs, Ken Resnicow, Kelley M. Kidwell, Emerson Delacroix, Sarah Austin, Erika N. Hanson, Elizabeth Bacon, Erika Koeppe, Stefanie Goodall, Matthew Demerath, Elizabeth A. Rizzo, Shayna Weiner, Sarah T. Hawley, Wendy R. Uhlmann, J. Scott Roberts, Elena M. Stoffel

Comparison of posterior muscle-preserving selective laminectomy and laminectomy with fusion for treating cervical spondylotic myelopathy: study protocol for a randomized controlled trial

Anna MacDowall, Håkan Löfgren, Erik Edström, Helena Brisby, Catharina Parai, Adrian Elmi-Terander

Adjustment for baseline characteristics in randomized trials using logistic regression: sample-based model versus true model

Thomas Perneger, Christophe Combescure, Antoine Poncet

  • Open Access
  • Correction

Correction: A protocol for a randomized clinical trial assessing the efficacy of hypertonic dextrose injection (prolotherapy) in chronic ankle instability

Regina Wing Shan Sit, Ricky Wing Keung Wu, Samuel Ka Kin Ling, Bo Wang, Dicken Cheong Chun Chan, Benjamin Hon Kei Yip, Samuel Yeung Shan Wong, Kenneth Dean Reeves, David Rabago

  • Open Access
  • Research

Comparing the effects of breastfeeding in the laid-back and cradle position upon the experiences of primiparous women: a parallel randomized clinical trial

Asefe Bashiri, Leila Amiri-Farahani, Hamid Salehiniya, Sally Pezaro

  • Open Access
  • Research

Effect of resistance vs. aerobic exercise in pre-diabetes: an RCT

Xijuan Luo, Zhengzhen Wang, Bowen Li, Xianbo Zhang, Xin Li

  • Open Access
  • Correction

Correction: Prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO): study protocol for a randomized, controlled, outcome assessor-blinded trial

Stefan J. Schaller, Jörn Kiselev, Verena Loidl, Wilm Quentin, Katrin Schmidt, Rudolf Mörgeli, Tanja Rombey, Reinhard Busse, Ulrich Mansmann, Claudia Spies

A multi-center, open-label, randomized study to explore efficacy and safety of baricitinib in active primary Sjogren’s syndrome patients

Wei Bai, Fan Yang, Huji Xu, Wei Wei, Hongbin Li, Liyun Zhang, Yi Zhao, Xiaofei Shi, Yan Zhang, Xiaofeng Zeng, Xiaomei Leng

  • Open Access
  • Obesity
  • Study protocol

Design of the Building Research in CRC prevention (BRIDGE-CRC) trial: a 6-month, parallel group Mediterranean diet and weight loss randomized controlled lifestyle intervention targeting the bile acid-gut microbiome axis to reduce colorectal cancer risk among African American/Black adults with obesity

Andrew McLeod, Patricia Wolf, Robert S. Chapkin, Laurie A. Davidson, Ivan Ivanov, Michael Berbaum, Lauren R. Williams, H. Rex Gaskins, Jason Ridlon, Jen Sanchez-Flack, Lara Blumstein, Linda Schiffer, Alyshia Hamm, Kate Cares, Mirjana Antonic, Beatriz Penalver Bernabe, Marian Fitzgibbon, Lisa Tussing-Humphreys

  • Open Access
  • Care
  • Study protocol

LOFIT (Lifestyle front Office For Integrating lifestyle medicine in the Treatment of patients): a novel care model towards community-based options for lifestyle change—study protocol

Marlinde L. van Dijk, Leonie M. te Loo, Joyce Vrijsen, Inge van den Akker-Scheek, Sanne Westerveld, Marjan Annema, André van Beek, Jip van den Berg, Alexander L. Boerboom, Adrie Bouma, Martine de Bruijne, Jeroen Crasborn, Johanna M. van Dongen, Anouk Driessen, Karin Eijkelenkamp, Nies Goelema, Jasmijn Holla, Johan de Jong, Anoek de Joode, Arthur Kievit, Josine van’t Klooster, Hinke Kruizenga, Marike van der Leeden, Lilian Linders, Jenny Marks-Vieveen, Douwe Johannes Mulder, Femmy Muller, Femke van Nassau, Joske Nauta, Suzanne Oostvogels, Jessica Oude Sogtoen, Hidde P. van der Ploeg, Patrick Rijnbeek, Linda Schouten, Rhoda Schuling, Erik H. Serné, Simone Smuling, Maarten R. Soeters, Evert A. L. M. Verhagen, Johannes Zwerver, Rienk Dekker, Willem van Mechelen, Judith G. M. Jelsma

Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC)

Inger Burnett-Zeigler, Elayne Zhou, Jennifer H. Martinez, Katelyn Zumpf, Lynette Lartey, Judith T. Moskowitz, Katherine L. Wisner, Thomas McDade, C. Hendricks Brown, Jacqueline Gollan, Jody D. Ciolino, Jacob M. Schauer, Lucia C. Petito

Distance-based delivery of exercise for people treated for breast, prostate or colorectal cancer: a study protocol for a randomised controlled trial of EX-MED Cancer Sweden

Melissa Kotte, Kate A. Bolam, Sara Mijwel, Renske Altena, Prue Cormie, Yvonne Wengström

Study protocol: short against long antibiotic therapy for infected orthopedic sites — the randomized-controlled SALATIO trials

Ilker Uçkay, Stephan Wirth, Björn Zörner, Sandro Fucentese, Karl Wieser, Andreas Schweizer, Daniel Müller, Patrick Zingg, Mazda Farshad

  • Open Access
  • Caries
  • Study protocol

Impact of virtual supervised tooth brushing on caries experience and quality of life among primary school children: study protocol for a randomized controlled trial

Haya Alayadi, Areej Alsiwat, Haifa AlAkeel, Munirah Alaskar, Maram Alwadi, Wael Sabbah

Digital peer-to-peer support programme for informal caregivers of people living with motor neuron disease: study protocol for a multi-centre parallel group, single-blinded (outcome assessor) randomised controlled superiority trial

Louise Rose, Thilipan Thaventhiran, Esther Hobson, Rebecca Rogers, Kirsty James, Petrina Chu, Ben Carter, Christina Faull, Sian Saha, Jeong Su Lee, Georgios Kaltsakas, Christopher McDermott, Michelle Ramsay

Proportion of clinical holistic responders in patients with persistent spinal pain syndrome type II treated by subthreshold spinal cord stimulation compared to best medical treatment: a study protocol for a multicentric randomised controlled trial (TRADITION)

Lisa Goudman, Koen Putman, Leen Van Doorslaer, Maxime Billot, Manuel Roulaud, Philippe Rigoard, Bart Billet, Bart Bryon, Mark Plazier, Vincent Raymaekers, Johan Vangeneugden, Maarten Moens

Correction: Prophylactic abdominal drainage or no drainage after distal pancreatectomy (PANDORINA): a study protocol of a binational multicenter randomized controlled trial

F. L. Vissers, A. Balduzzi, E. A. van Bodegraven, J. van Hilst, S. Festen, M. Abu Hilal, H. J. Asbun, J. S. D. Mieog, B. Groot Koerkamp, O. R. Busch, F. Daams, M. Luyer, M. De Pastena, G. Malleo, G. Marchegiani, J. Klaase, I. Q. Molenaar, R. Salvia, H. C. van Santvoort, M. Stommel, D. Lips, M. Coolsen, C. Bassi, C. van Eijck, M. G. Besselink

  • Open Access
  • Care
  • Study Protocol

Community paramedic hospital reduction and mitigation program: study protocol for a randomized pragmatic clinical trial

Jennifer L. Ridgeway, Erin O. Wissler Gerdes, Andrew Dodge, Chad P. Liedl, Michael B. Juntunen, Wendy J. S. Sundt, Amy Glasgow, Michelle A. Lampman, Angela L. Fink, Sara B. Severson, Grace Lin, Richard R. Sampson, Robert P. Peterson, Brian M. Murley, Aaron B. Klassen, Anuradha Luke, Paul A. Friedman, Tamara E. Buechler, James S. Newman, Rozalina G. McCoy

Effect of vitamin D supplementation versus placebo on recovery delay among COVID-19 Tunisian patients: a randomized-controlled clinical trial

Hela Abroug, Amani Maatouk, Cyrine Bennasrallah, Wafa Dhouib, Manel Ben Fredj, Imen Zemni, Meriem Kacem, Salma Mhalla, Sarra Nouira, Manel Ben Belgacem, Aymen Nasri, Rim Klii, Chawki Loussaief, Nissaf Ben Alya, Ines Bouanene, Asma Belguith Sriha

Effectiveness of an 8-week overground walking with paretic lower limb loading on spatiotemporal gait parameters and motor function among chronic stroke survivors: a study protocol for a randomised controlled trial

Abdulhamid U. Maje, Aminu A. Ibrahim

Effectiveness of four deconstructive meditative practices on well-being and self-deconstruction: study protocol for an exploratory randomized controlled trial

Javier García-Campayo, Rinchen Hijar-Aguinaga, Yolanda López-Del-Hoyo, Rosa Magallón-Botaya, Selene Fernández-Martínez, Alberto Barceló-Soler, Joaquim Soler-Ribaudi, Jesus Montero-Marin

  • Open Access
  • Rape
  • Study protocol

Modified prolonged exposure therapy as Early Intervention after Rape (The EIR-study): study protocol for a multicenter randomized add-on superiority trial

Tina Haugen, Joar Øveraas Halvorsen, Oddgeir Friborg, Melanie Rae Simpson, Paul Jarle Mork, Gustav Mikkelsen, Ask Elklit, Barbara O. Rothbaum, Berit Schei, Cecilie Hagemann

  • Open Access
  • Review

Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials

Ana Teresita Mazzochi, Martin Dennis, Ho-Yan Yvonne Chun

  • Open Access
  • Malaria
  • Study protocol

BOHEMIA: Broad One Health Endectocide-based Malaria Intervention in Africa—a phase III cluster-randomized, open-label, clinical trial to study the safety and efficacy of ivermectin mass drug administration to reduce malaria transmission in two African settings

Carlos Chaccour, Aina Casellas, Felix Hammann, Paula Ruiz-Castillo, Patricia Nicolas, Julia Montaña, Mary Mael, Prashant Selvaraj, Urs Duthaler, Sigilbert Mrema, Mwaka Kakolwa, Issa Lyimo, Fredros Okumu, Achla Marathe, Roger Schürch, Eldo Elobolobo, Charfudin Sacoor, Francisco Saute, Kang Xia, Caroline Jones, Cassidy Rist, Marta Maia, N. Regina Rabinovich

Effects of N-acetylcysteine on systemic lupus erythematosus disease activity and its associated complications: a randomized double-blind clinical trial study

Mitra Abbasifard, Hossein Khorramdelazad, Abdolrahman Rostamian, Mohsen Rezaian, Pooya Saeed Askari, Gholamhosein Taghipur Khajeh Sharifi, Moein Kardoust Parizi, Mobina Taghipour Khajeh Sharifi, Seyed Reza Najafizadeh

The Skin Antiseptic agents at Vaginal dElivery (SAVE) trial: study protocol for a randomized controlled trial

Young Mi Jung, Seung Mi Lee, So Yeon Kim, Jin Hoon Chung, Hye-Sung Won, Kyung A Lee, Mi Hye Park, Geum Joon Cho, Min-Jeong Oh, Eun Saem Choi, Ki Hoon Ahn, Soon-Cheol Hong, Ji-Hee Sung, Cheong-Rae Roh, Sun Min Kim, Byoung Jae Kim, Hyeon Ji Kim, Kyung Joon Oh, Subeen Hong, In Yang Park, Joong Shin Park

Metabolomics-based Sleepiness Markers for Risk Prevention and Traffic Safety (ME-SMART): a monocentric, controlled, randomized, crossover trial

Michael Scholz, Stefan Lakaemper, Kristina Keller, Akos Dobay, Andrea Eva Steuer, Hans-Peter Landolt, Thomas Kraemer

BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy

Hilary L. Byrne, Elisabeth Steiner, Jeremy Booth, Gillian Lamoury, Marita Morgia, Kylie Richardson, Leigh Ambrose, Kuldeep Makhija, Cameron Stanton, Benjamin Zwan, Regina Bromley, John Atyeo, Shona Silvester, Natalie Plant, Paul Keall

  • Open Access
  • Study protocol

A randomised controlled trial investigating the effect of improving the cleaning and disinfection of shared medical equipment on healthcare-associated infections: the CLEaning and Enhanced disiNfection (CLEEN) study

Katrina Browne, Nicole White, Peta Tehan, Philip L Russo, Maham Amin, Andrew J. Stewardson, Allen C. Cheng, Kirsty Graham, Gabrielle O’Kane, Jennie King, Martin Kiernan, David Brain, Brett G. Mitchell

Movement and health beyond care, MoviS: study protocol for a randomized clinical trial on nutrition and exercise educational programs for breast cancer survivors

Valentina Natalucci, Carlo Ferri Marini, Mauro De Santi, Giosuè Annibalini, Francesco Lucertini, Luciana Vallorani, Andrea Rocco Panico, Davide Sisti, Roberta Saltarelli, Sabrina Donati Zeppa, Deborah Agostini, Marco Gervasi, Giulia Baldelli, Eugenio Grassi, Alessandra Nart, Massimo Rossato, Vincenzo Biancalana, Giovanni Piccoli, Piero Benelli, Anna Villarini, Matteo Somaini, Vincenzo Catalano, Stefania Guarino, Alice Pietrelli, Silvia Monaldi, Donatella Sarti, Simone Barocci, Marco Flori, Marco Bruno Luigi Rocchi, Giorgio Brandi, Vilberto Stocchi, Rita Emili, Elena Barbieri

  • Open Access
  • Study protocol

A randomised open-label trial to assess outpatient induction of labour (HOMEIND) and compare efficacy of Propess vs Dilapan-S® for induction of labour at 39 weeks’ gestation in normal risk nulliparous women: study protocol for a randomised controlled trial

Sarah M. Nicholson, Orla Smith, Susan Hatt, Zara Molphy, Patrick Dicker, Karen Flood, Fergal Malone

Case management and care expertise as a prevention approach for adults with intellectual disabilities (FaPP-MgB): study protocol for a randomized-controlled trial

Stephan Nadolny, Dirk Bruland, Marie Grunwald, Annika Gröndahl, Jessica Grammatico, Miriam Tariba Richter, Christian Grebe, Änne-Dörte Latteck

Characterizing modifications to a comparative effectiveness research study: the OPTIMIZE trial—using the Framework for Reporting Adaptations and Modifications to Evidence-based Interventions (FRAME)

Julie M. Fritz, Tom Greene, Gerard P. Brennan, Kate Minick, Elizabeth Lane, Stephen T. Wegener, Richard L. Skolasky

  • Open Access
  • Care
  • Study protocol

Child Adult Relationship Enhancement in Primary Care (PriCARE): study design/protocol for a randomized trial of a primary care-based group parenting intervention to prevent child maltreatment

Samantha Schilling, Byron J. Powell, Paul W. Stewart, Joanne N. Wood

The impact of gingivitis reduction on lung function: a randomized trial under intensified oral hygiene

Jan Kühnisch, Tianyu Zhao, Randi J. Bertelsen, Rudolf A. Jörres, Dennis Nowak, Joachim Heinrich

Modified ultrasound scalpel haemorrhoidectomy versus conventional haemorrhoidectomy for mixed haemorrhoids: a study protocol for a single-blind randomised controlled trial

Keqiang Yu, Haijun Li, Ping Xue, Zhidi Xie, Minghui Tang, Hongbo He, Jing Wu

Efficacy and auditory biomarker analysis of fronto-temporal transcranial direct current stimulation (tDCS) in targeting cognitive impairment associated with recent-onset schizophrenia: study protocol for a multicenter randomized double-blind sham-controlled trial

Clément Dondé, Julien Bastin, Arnaud Pouchon, Nicolas Costes, Eric Fakra, Filipe Galvão, Aurélia Gay, Frédéric Haesebaert, Laurent Lamalle, Inès Mérida, Maxence Rigon, Fabien Schneider, Irène Troprès, Jérôme Brunelin, Mircea Polosan

Correction: Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial

Gina Del Fabbro, Paula McKay, Lehana Thabane, Randi E. McCabe, Matilda Nowakowski, Christy Shibu, Natalie Fleming, Herman Johal, Gerard Slobogean, Roman M. Natoli, I. Leah Gitajn, Prism Schneider, P. J. Devereaux, Emil H. Schemitsch, Mohit Bhandari, Gordon H. Guyatt, Eleni Hapidou, Delia Chiaramonte, Henrick Kehlet, James Khan, Aaron Johnson, Diane Heels-Ansdell, Sofia Bzovsky, Brad A. Petrisor, Dale Williams, Bill Ristevski, Jamal Al-Asiri, Matthew Denkers, Kris Rajaratnam, Jodi L. Gallant, Sarah MacRae, Kaitlyn Pusztai, Sara Renaud, Nicki Johal, Steven Papp, Karl-Andre Lalonde, Bradley Meulenkamp, Allan Liew, Manisha Mistry, Braden Gammon, Wade Gofton, Geoffrey Wilkin, Melanie Dodd-Moher, David Puskas, Travis Marion, Tina Lefrancois, Jubin Payandeh, Claude Cullinan, Tracy Wilson, Kurt Droll, Michael Riediger, Rabail Siddiqui, Shalyn Littlefield, Simrun Chahal, Paige Wagar, Prism S. Schneider, Tosin Ogunleye, Tanya Cherppukaran, Karin Lienhard, Nicholas Smith, Sarah Anthony, Krista Butt, La Shann Selby, Murali Kovvur, Joshua Lawrence, Skyler Sampson, Kristin Turner, Todd Jaeblon, Haley K. Demyanovich, Sneh Talwar, Caroline Benzel, Theresa Chockbengboun, Devin Mullin, Logan Bateman, Melanie Christian, Peter DePalo, Paul J. Appleton, John J. Wixted, Edward K. Rodriguez, Michael F. McTague, Katiri Wagner, Kristina Brackpool, Kate Hegermiller, Nhi Nguyen, Courteney Fentz, Maricela Diaz, Jill Niceley, Kyle J. Jeray, Thomas M. Schaller, Michael S. Sridhar, John D. Adams, Richard W. Gurich Jr, Stephanie L. Tanner, Kyle Adams, Michelle Donohue, Emily Bray, Calleigh Brignull, Harper Sprouse

  • Open Access
  • Research

Effects of Ving Tsun sticking-hand training on lower limb sensorimotor performance among community-dwelling middle-aged and older adults: a randomized controlled trial

Shirley S. M. Fong, Louisa M. Y. Chung, Timothy T. T. Yam, Joanne W. Y. Chung, Young-Hyeon Bae, Yang Gao, Jessie S. M. Chan, Hsing-Kuo Wang

Esketamine combined with pregabalin on acute postoperative pain in patients undergoing resection of spinal neoplasms: study protocol for a randomized controlled trial

Wanchen Sun, Juan Wang, Jing Wang, Jingyi Fan, Yang Zhou, Yunzhen Wang, Ruquan Han

Priming locomotor training with transspinal stimulation in people with spinal cord injury: study protocol of a randomized clinical trial

Andreas Skiadopoulos, Grace O. Famodimu, Shammah K. Solomon, Parul Agarwal, Noam Y. Harel, Maria Knikou

Efficiency of probiotics in elderly patients undergoing orthopedic surgery for postoperative cognitive dysfunction: a study protocol for a multicenter, randomized controlled trial

Xiaoyi Zhang, Yuwen Chen, Ying Tang, Yizhe Zhang, Xiao Zhang, Diansan Su

  • Open Access
  • Care
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Proactive and Integrated Management and Empowerment in Parkinson’s Disease protocol for a randomised controlled trial (PRIME-UK) to evaluate a new model of care

Fiona E. Lithander, Emma Tenison, Jan Ypinga, Angelika Halteren, Matthew D. Smith, Katherine Lloyd, Edward W. Richfield, Danielle E. Brazier, Mícheál Ó Breasail , Agnes J. Smink, Chris Metcalfe, William Hollingworth, Bas Bloem, Marten Munneke, Yoav Ben-Shlomo, Sirwan K. L. Darweesh, Emily J. Henderson

Is sling immobilization necessary after open Latarjet surgery for anterior shoulder instability? A randomized control trial

Patrick Goetti, Tiago Martinho, Antoine Seurot, Hugo Bothorel, Alexandre Lädermann

  • Open Access
  • Review

Clinical research for life-threatening illnesses requiring emergency hospitalisation: a critical interpretive synthesis of qualitative data related to the experience of participants and their caregivers

David S. Lawrence, Agnes Ssali, Joseph N. Jarvis, Janet Seeley

Perimenopausal Effects of Estradiol on Anhedonia and Psychosis Study (PEEPs): study protocol for a neural and molecular mechanistic clinical trial

Melissa J. M. Walsh, Kathryn Gibson, Megan Hynd, Tory A. Eisenlohr-Moul, Erin C. Walsh, Lauren Schiff, Fred Jarskog, David Lalush, Gabriel S. Dichter, Crystal E. Schiller

  • Open Access
  • Commentary

Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action

Amy M. Russell, Victoria Shepherd, Kerry Woolfall, Bridget Young, Katie Gillies, Anna Volkmer, Mark Jayes, Richard Huxtable, Alexander Perkins, Nurulamin M. Noor, Beverley Nickolls, Julia Wade

Impact of non-muscle cutting periumbilical transverse incision on the risk of incisional hernia as compared to midline incision during laparoscopic colon cancer surgery: a study protocol for a multi-centre randomised controlled trial

Soo Yeun Park, Gi Won Ha, Soo Young Lee, Chang Hyun Kim, Gyung Mo Son

Surgical treatment versus observation in moderate intermittent exotropia (SOMIX): study protocol for a randomized controlled trial

Tao Shen, Jingchang Chen, Ying Kang, Daming Deng, Xiaoming Lin, Heping Wu, Jinrong Li, Zhonghao Wang, Xuan Qiu, Ling Jin, Jianhua Yan

Evaluation of a smartphone application for self-help for patients with social anxiety disorder: a randomized controlled study—SMASH

Jan Marius Schittenhelm, Christoph von Borell, Celina Clément, Johanna Schüller, Ulrich Stangier, Juergen Hoyer

Trial protocol for a multicenter randomized controlled trial to assess the efficacy and safety of intravenous ketamine for chronic daily headaches: the “KetHead” trial

Yasmine Hoydonckx, Mandeep Singh, Ian Gilron, James Khan, Samer Narouze, Albert Dahan, Kathryn Curtis, Xingshan Cao, Jamal Kara, Anuj Bhatia

  • Open Access
  • Opioids
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The efficacy of nalmefene on anesthetic recovery of patients: a study protocol for a multicenter randomized controlled trial

Xiaowen Ma, Jueying Liu, Ying Tang, Qiueyue Lian, Xiaorong Huai, Wanfeng Liu, Diansan Su

  • Open Access
  • Research

Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation

Louisa Lawrie, Eilidh M. Duncan, Robert Lendrum, Victoria Lebrec, Katie Gillies

  • Open Access
  • Methodology

Creating a best practice template for participant communication plans in global health clinical studies

Colleen E. Shelly, Caroline Logan, Beth Skorochod, Alison Wiyeh, Duduzile Ndwandwe, Augustine Choko, Innocent Valea, Boghuma K. Titanji

  • Open Access
  • Methodology

Participant recruitment, baseline characteristics and at-home-measurements of cardiometabolic risk markers: insights from the Supreme Nudge parallel cluster-randomised controlled supermarket trial

Josine M. Stuber, Beryl A. C. E. van Hoek, Anne L. Vos, Edith G. Smit, Jeroen Lakerveld, Joreintje D. Mackenbach, Joline W. J. Beulens, Jody C. Hoenink, Femke Rutters, Wilma E. Waterlander, Denise T. D. de Ridder, Marleen Gillebaart, Stephanie Blom, Femke E. de Boer, Gert-Jan de Bruijn, Michel C. A. Klein, Jacqueline E. W. Broerse, Tjerk-Jan Schuitmaker-Warnaar, Cédric N. H. Middel, Yvonne T. van der Schouw, Ivonne Sluijs, Marjolein C. Harbers, Elizabeth Velema

  • Open Access
  • Methodology

Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study

Tora Söderström Gaden, Christian Gold, Jörg Assmus, Ingrid Kvestad, Andreas Størksen Stordal, Łucja Bieleninik, Claire Ghetti

Efficacy and safety of selective JAK 1 inhibitor filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: comparative study with filgotinib and tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial

Toshimasa Shimizu, Shin-ya Kawashiri, Shimpei Morimoto, Yurika Kawazoe, Shohei Kuroda, Rina Kawasaki, Yasuko Ito, Rieko Kiya, Shuntaro Sato, Hiroshi Yamamoto, Atsushi Kawakami

  • Open Access
  • Study protocol

Effectiveness of the SMART training intervention on ankle joint function in patients with first-time acute lateral ankle sprain: study protocol for a randomized controlled trial

Janina Tennler, Christian Raeder, Arthur Praetorius, Tobias Ohmann, Christian Schoepp

  • Open Access
  • Care
  • Study protocol

mHealth interventions to reduce stress in healthcare workers (fitcor): study protocol for a randomized controlled trial

Hannes Baumann, Luis Heuel, Laura L. Bischoff, Bettina Wollesen

  • Open Access
  • Research

Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis

Michelle Tew, Max Catchpool, John Furler, Katie De La Rue, Philip Clarke, Jo-Anne Manski-Nankervis, Kim Dalziel

Investigation on the effect of antimicrobial photodynamic therapy as an adjunct for management of deep caries lesions—study protocol for a randomized, parallel groups, controlled clinical trial

Luiz Filipe Barbosa Martins, Leandro Rodrigues de Sena, Diego Martins de Paula, Victor Pinheiro Feitosa, Anna Carolina Ratto Tempestini Horliana, Kristianne Porta Santos Fernandes, Raquel Agnelli Mesquita-Ferrari, Lara Jansiski Motta, Marcela Leticia Leal Gonçalves, Sandra Kalil Bussadori

  • Open Access
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Effect of low-dose aspirin on urinary 11-dehydro-thromboxane B2 in the ASCEND (A Study of Cardiovascular Events iN Diabetes) randomized controlled trial

Sarah Parish, Georgina Buck, Theingi Aung, Marion Mafham, Sarah Clark, Michael R. Hill, Rory Collins, Louise Bowman, Jane Armitage

DEPROMP Trial: the additive value of PSMA-PET/CT-guided biopsy for prostate cancer management in biopsy naïve men—study protocol for a randomized trial

P. Krausewitz, R. A. Bundschuh, F. C. Gaertner, M. Essler, U. Attenberger, J. Luetkens, G. Kristiansen, M. Muders, C-H. Ohlmann, S. Hauser, J. Ellinger, M. Ritter

Safety and efficacy comparison of polyethylene glycol, hemp seed oil, and 5% sugar brine for bowel preparation in older patients: study protocol for a randomized controlled trial

Xing Wang Zhu, Jun Yan, Long Miao, Ying Li He, Hai Ping Wang, Xun Li

  • Open Access
  • Study protocol

A Smart Service System for Spatial Intelligence and Onboard Navigation for Individuals with Visual Impairment (VIS4ION Thailand): study protocol of a randomized controlled trial of visually impaired students at the Ratchasuda College, Thailand

Mahya Beheshti, Tahereh Naeimi, Todd E. Hudson, Chen Feng, Pattanasak Mongkolwat, Wachara Riewpaiboon, William Seiple, Rajesh Vedanthan, John-Ross Rizzo

Effects of an 8-week multimodal exercise program on ground reaction forces and plantar pressure during walking in boys with autism spectrum disorder

Mahrokh Dehghani, Amir Ali Jafarnezhadgero, Mohamad Abdollahpour Darvishani, Shirin Aali, Urs Granacher

  • Open Access
  • Review

Barriers and facilitators to the recruitment of disabled people to clinical trials: a scoping review

Sameed Shariq, Alexandra M Cardoso Pinto, Shyam Sundar Budhathoki, Marie Miller, Suzie Cro

Dual-task versus single-task gait rehabilitation after stroke: the protocol of the cognitive-motor synergy multicenter, randomized, controlled superiority trial (SYNCOMOT)

Sophie Tasseel-Ponche, Martine Roussel, Monica N. Toba, Thibaud Sader, Vincent Barbier, Arnaud Delafontaine, Jonathan Meynier, Carl Picard, Jean-Marc Constans, Alexis Schnitzler, Olivier Godefroy, Alain Pierre Yelnik

Implementation of offering choice of pulmonary rehabilitation location to people with COPD: a protocol for the process evaluation of a cluster randomised controlled trial

Narelle S Cox, Anne E Holland, Arwel W Jones, Christine F McDonald, Paul O’Halloran, Ajay Mahal, Graham Hepworth, Natasha A Lannin

Internet-based stress recovery intervention for adolescents: study protocol for a randomized controlled trial

Paulina Zelviene, Agniete Kairyte, Austeja Dumarkaite, Augustė Nomeikaite, Evaldas Kazlauskas

Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial

Rosa Klotz, Markus K. Diener, Thomas Schmidt, Thilo Hackert, Sandra Graf, Hans F. Fuchs, Peter Grimminger, Jan-Hendrick Egberts, Ines Gockel, Pieter C. van der Sluis, Colette Doerr-Harim, Christina Klose, Manuel Feißt, Andre L. Mihaljevic

  • Open Access
  • Commentary

Incomplete reporting of complex interventions: a call to action for journal editors to review their submission guidelines

Mairead Ryan, Tammy Hoffmann, Riikka Hofmann, Esther van Sluijs

Efficacy of silymarin in patients with non-alcoholic fatty liver disease — the Siliver trial: a study protocol for a randomized controlled clinical trial

Camila Ribeiro de Avelar, Beatriz Vieira Coelho Nunes, Betina da Silva Sassaki, Mariana dos Santos Vasconcelos, Lucivalda Pereira Magalhães de Oliveira, André Castro Lyra, Allain Amador Bueno, Rosângela Passos de Jesus

Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE

Sam Kant, Dixon B. Kaufman, Lenuta Micsa, Daniel C. Brennan

  • Open Access
  • Study protocol

Individual supported work placements (ReISE) for improving sustained return to work in unemployed people with persistent pain: study protocol for a cohort randomised controlled trial with embedded economic and process evaluations

Pål André Amundsen, Martin Underwood, Kim Burton, Margreth Grotle, Ira Malmberg-Heimonen, Adnan Kisa, Milada Cvancarova Småstuen, Thor Einar Holmgard, Amy Martinsen, Jakob Lothe, Pernille Marie Stähr Irgens, Magnus Højen, Sølvi Spilde Monsen, Robert Froud

A randomised study of rituximab and belimumab sequential therapy in PR3 ANCA-associated vasculitis (COMBIVAS): design of the study protocol

Mark E. McClure, Seerapani Gopaluni, James Wason, Robert B. Henderson, Andre Van Maurik, Caroline C.O. Savage, Charles D. Pusey, Alan D. Salama, Paul A. Lyons, Jacinta Lee, Kim Mynard, David R. Jayne, Rachel B. Jones

Evaluating the efficacy of an online, family-based intervention to promote adolescent sexual health: a study protocol for a randomized controlled trial

Vincent Guilamo-Ramos, Adam Benzekri, Marco Thimm-Kaiser

  • Open Access
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Effectiveness of structured self-evaluation of video recorded performance on peripheral intravenous catheter insertion: a randomised control trial study protocol

Orlaith Hernon, Edel McSharry, Andrew Simpkin, Iain MacLaren, Peter J. Carr

  • Open Access
  • Care
  • Methodology

Re-analysis of ventilator-free days (VFD) in acute respiratory distress syndrome (ARDS) studies

Rejina Mariam Verghis, Cliona McDowell, Bronagh Blackwood, Bohee Lee, Daniel F. McAuley, Mike Clarke

  • Open Access
  • Study protocol

Little All Children in Focus (Little ACF), evaluation of a parental support program for parents of children aged 1–2 years: study protocol for a randomized controlled trial

Lisa Blom, Anna Edenius, Pia Enebrink, Anders Hjern, Sven Arne Silfverdal, Johan Åhlén, Malin Bergström, Lene Lindberg

PROphylaxis for paTiEnts at risk of COVID-19 infecTion (PROTECT-V)

Toby J. L. Humphrey, Davinder Dosanjh, Thomas F. Hiemstra, Alex Richter, Michael Chen-Xu, Wendi Qian, Vivekanand Jha, Katrina Gatley, Rakshya Adhikari, Francis Dowling, Rona M. Smith

The effects of qigong intervention based on the Internet on quality of life and physical fitness in Chinese postoperative breast cancer patients: a protocol of randomized controlled trial

Chengxiang Li, Xiaosheng Dong, Lina Yu, Kai Yuan, Xiangren Yi, Yuanlong Shen, Hu Niu

Correction: The effect of a phytoestrogen intervention and impact of genetic factors on tumor proliferation markers among Swedish patients with prostate cancer: study protocol for the randomized controlled PRODICA trial

Rebecca Ahlin, Sanna Nybacka, Andreas Josefsson, Johan Stranne, Gunnar Steineck, Maria Hedelin

  • Open Access
  • Study protocol

The COSI trial: a study protocol for a multi-centre, randomised controlled trial to explore the clinical and cost-effectiveness of the Circle of Security-Parenting Intervention in community perinatal mental health services in England

Camilla Rosan, Kim Alyousefi-van Dijk, Zoe Darwin, Daphne Babalis, Victoria Cornelius, Rachel Phillips, Lani Richards, Hannah Wright, Steve Pilling, Pasco Fearon, Elena Pizzo, Peter Fonagy

Effects of a remote-handling-concept–based task-oriented arm training (ReHab-TOAT) on arm-hand skill performance in chronic stroke: a study protocol for a two-armed randomized controlled trial

Jule Elmanowski, Henk Seelen, Richard Geers, Melanie Kleynen, Jeanine Verbunt

  • Open Access
  • Commentary

The need for a new keyword — “Trial registry-metaresearch” — to track certain uses of clinical trial registry records

Gayatri Saberwal

  • Open Access
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Impact of a multifaceted early mobility intervention for critically ill children — the PICU Up! trial: study protocol for a multicenter stepped-wedge cluster randomized controlled trial

Razvan Azamfirei, Colleen Mennie, Victor D. Dinglas, Arooj Fatima, Elizabeth Colantuoni, Ayse P. Gurses, Michele C. Balas, Dale M. Needham, Sapna R. Kudchadkar, Mashael Alqahtani, Justin Azar, John W. Berkenbosch, Ashley R. Bjorklund, Kelly L. Corbett, Molly V. Dorfman, Andrew W. Kiragu, Matthew A. Musick, Melissa B. Porter, Charles B. Rothschild, Elizabeth E. Scarlett, Tracie C. Walker, Melvin L. Wright

Capnographic monitoring reduces hypoxia incidence in older patients undergoing gastrointestinal endoscopy under propofol sedation: study protocol for a multicenter randomized controlled trial

Qiuyue Lian, Shaoyi Chen, Xiangyang Cheng, Jie Zhang, Weifeng Yu, Renlong Zhou, Diansan Su

Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial

Kris Hage, Anders Boyd, Udi Davidovich, Paul Zantkuijl, Elske Hoornenborg, Amy Matser, Ellen Generaal, Janke Schinkel, Eve Todesco, Marc van der Valk, Hayette Rougier, Karine Lacombe, Maria Prins, S. Rebers, F. Pijnappel, H. van Eden, J. Stalenhoef, F. van Malsem, R. van Heerde, H. Nobel, W. Alers, L. Elsenburg, D. Verhagen, F. Lauw, M. van Wijk, J. den Hollander, A. Brouwer, E. Leyten, S. Wildenbeest, T. Mudrikova, M. van der Kerkhof, C. Kips, L. Flobbe, F. Mouthaan, S. Elzinga, D. Loomans, E. Ersan, K. Yap, K. de Jong, I. Peters, S. de Graaf, Ejay de Wit

  • Open Access
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The protocol for the prehabilitation for thoracic surgery study: a randomized pragmatic trial comparing a short home-based multimodal program to aerobic training in patients undergoing video-assisted thoracoscopic surgery lobectomy

Yuchao Liu, Zijia Liu, Yuelun Zhang, Yushang Cui, Lijian Pei, Yuguang Huang

Individualized flow-controlled versus conventional pressure-controlled ventilation in on-pump heart surgery (FLOWVENTIN HEARTSURG): study protocol for a randomized controlled trial

Simon Becker, Romina Schnitzler, Martin Rembecki, Johannes Geppert, Christian T. Kurz, Lisa-Marie Wichelhaus, Nina Timmesfeld, Peter K. Zahn

  • Open Access
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Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial

Meghan Mayhew, Benjamin H. Balderson, Andrea J. Cook, John F. Dickerson, Charles R. Elder, Alison J. Firemark, Irina V. Haller, Morgan Justice, Francis J. Keefe, Carmit K. McMullen, Maureen C. O’Keeffe-Rosetti, Ashli A. Owen-Smith, Christine Rini, Jennifer L. Schneider, Michael Von Korff, Laura D. Wandner, Lynn L. DeBar

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial

Natasha C. Pocovi, Petra L. Graham, Chung-Wei Christine Lin, Simon D. French, Jane Latimer, Dafna Merom, Anne Tiedemann, Christopher G. Maher, Johanna M. van Dongen, Ornella Clavisi, Mark J. Hancock

  • Open Access
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The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 1: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial

Laurel D. Sarfan, Emma R. Agnew, Marlen Diaz, Lu Dong, Krista Fisher, Julia M. Spencer, Shayna A. Howlett, Rafael Esteva Hache, Catherine A. Callaway, Amy M. Kilbourne, Daniel J. Buysse, Allison G. Harvey

Effects of repetitive functional magnetic stimulation in the sacral nerve in patients with neurogenic detrusor overactivity after suprasacral spinal cord injury: a study protocol for a randomized controlled trial

Jiyang Li, Jianxiong Wang, Yue Hu, Rui Jian, Yulu Zhao, Dan Li, Tenggang Wan, Wuga Jike, Fangyuan Xu, Maomao Huang

A comparison of different physical stimulation combined with platelet-rich plasma for the treatment of knee osteoarthritis: study protocol for a randomized controlled trial

Yan Liu, Xiao-Na Xiang, Qian Wang, Hong-Chen He

  • Open Access
  • Correction

Correction: Study protocol for a randomized controlled trial evaluating the effectiveness of an internet-based self-help intervention to cope with psychological distress due to COVID-19 in the Italian general population: the RinasciMENTE project

Vanessa Bertuzzi, Michelle Semonella, Gerhard Andersson, Gian Mauro Manzoni, Gianluca Castelnuovo, Enrico Molinari, Giada Pietrabissa

Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO)

C. McLeod, J Ramsay, K. L. Flanagan, M. Plebanski, H. Marshall, M. Dymock, J. Marsh, M. J. Estcourt, U. Wadia, P. C. M. Williams, M. C. Tjiam, C. Blyth, K. Subbarao, S. Nicholson, S. Faust, R. B. Thornton, A. Mckenzie, T. L Snelling, P. Richmond

  • Open Access
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What do we talk about when we talk about “equipoise”? Stakeholder interviews assessing the use of equipoise in clinical research ethics

Brian Dewar, Stephanie Chevrier, Julie De Meulemeester, Mark Fedyk, Rosendo Rodriguez, Simon Kitto, Raphael Saginur, Michel Shamy

Fully constrained acetabular liner vs. dual mobility hip joint in the surgical treatment of metastatic bone disease of the hip: study protocol for a randomized, open-label, two-arm, non-inferiority trial evaluating the post-operative hip dislocation rate

Afrim Iljazi, Michala Skovlund Sørensen, Kolja Sebastian Weber, Allan Villadsen, Frank Eriksson, Michael Mørk Petersen

The relationship between different bispectral index and the occurrence of dreams in elective surgery under general anesthesia: protocol for a randomized controlled clinical trial

Yufei Zhang, Bijia Song, Junchao Zhu

Eye movement desensitization and reprocessing for adolescents with major depressive disorder: study protocol for a multi-site randomized controlled trial

C. C. Paauw, C. de Roos, M. G. T. Koornneef, B. M. Elzinga, T. M. Boorsma, M. A. Verheij, A. E. Dingemans

Exhaustive drainage versus fixed-time drainage for chronic subdural hematoma after one-burr hole craniostomy (ECHO): study protocol for a multicenter randomized controlled trial

Liang Wu, Yunwei Ou, Bingcheng Zhu, Xufei Guo, Xiaofan Yu, Long Xu, Jinping Li, Enshan Feng, Huaqing Li, Xiaodong Wang, Huaqun Chen, Zhaosheng Sun, Zaofu Liu, Dawei Yang, Hongbing Zhang, Zhigang Liu, Jie Tang, Shangfeng Zhao, Guobin Zhang, Jiemin Yao, Dongming Ma, Zelin Sun, Hui Zhou, Baiyun Liu, Weiming Liu

Correction: The clinical evaluation of electroacupuncture combined with mindfulness meditation for overweight and obesity: study protocol for a randomized sham-controlled clinical trial

Ching Yee Chung, Angela Wei Hong Yang, Alexander De Foe, Mingdi Li, George Binh Lenon

Efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing percutaneous coronary intervention: study protocol for a non-inferiority randomized controlled trial

Tienan Zhou, Yinghui Gong, Jingyuan Li, Yasong Wang, Xiaozeng Wang

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Strengthening primary care for diabetes and hypertension in Eswatini: study protocol for a nationwide cluster-randomized controlled trial

Michaela Theilmann, Ntombifuthi Ginindza, John Myeni, Sijabulile Dlamini, Bongekile Thobekile Cindzi, Dumezweni Dlamini, Thobile L. Dlamini, Maike Greve, Harsh Vivek Harkare, Mbuso Hleta, Philile Khumalo, Lutz M. Kolbe, Simon Lewin, Lisa-Rufaro Marowa, Sakhile Masuku, Dumsile Mavuso, Marjan Molemans, Nyasatu Ntshalintshali, Nomathemba Nxumalo, Brianna Osetinsky, Christopher Pell, Ria Reis, Fortunate Shabalala, Bongumusa R. Simelane, Lisa Stehr, Fabrizio Tediosi, Frank van Leth, Jan-Walter De Neve, Till Bärnighausen, Pascal Geldsetzer

BEAT CF pulmonary exacerbations core protocol for evaluating the management of pulmonary exacerbations in people with cystic fibrosis

Andre Schultz, Charlie McLeod, Scott Berry, Julie Marsh, Anne McKenzie, Mitch Messer, Jamie Wood, Ben Saville, Adam Jaffe, Sarath Ranganathan, Steve Stick, Peter Wark, Steve Webb, Tom Snelling

Comparing the effects of smartphone-based and face-to-face pulmonary rehabilitation education on caregiver burden and quality of life among the family caregivers of patients with chronic obstructive pulmonary disease: a randomized controlled field trial

Mobina Bahadori, Ramin Sami, Shahla Abolhassani, Vajihe Atashi

A multicentre, patient- and assessor-blinded, non-inferiority, randomised and controlled phase II trial to compare standard and torque teno virus-guided immunosuppression in kidney transplant recipients in the first year after transplantation: TTVguideIT

Frederik Haupenthal, Jette Rahn, Fabrizio Maggi, Fanny Gelas, Philippe Bourgeois, Christian Hugo, Bernd Jilma, Georg A. Böhmig, Harald Herkner, Michael Wolzt, Konstantin Doberer, Matthias Vossen, Daniele Focosi, Hannes Neuwirt, Miriam Banas, Bernhard Banas, Klemens Budde, Ondrej Viklicky, Paolo Malvezzi, Lionel Rostaing, Joris I. Rotmans, Stephan J. L. Bakker, Kathrin Eller, Daniel Cejka, Alberto Molina Pérez, David Rodriguez-Arias, Franz König, Gregor Bond, Georg Melzer, Martha del Alamo, Isabel Beneyto, David Navarro, Sophie Ohlmann

Influence of CReatine supplementation on mUScle mass and strength after stroke (ICaRUS Stroke Trial): study protocol for a randomized controlled trial

Juli Thomaz de Souza, Marcos F. Minicucci, Natália C. Ferreira, Bertha F. Polegato, Marina Politi Okoshi, Gabriel P. Modolo, Bethan E. Phillips, Philip J. Atherton, Kenneth Smith, Daniel Wilkinson, Adam Gordon, Suzana E. Tanni, Vladimir Eliodoro Costa, Maria Fernanda P. Fernandes, Silméia G. Zanati Bazan, Leonardo A. M. Zornoff, Rodrigo Bazan, Sérgio A. Rupp de Paiva, Paula Schmidt Azevedo

  • Open Access
  • Methodology

A retrospective analysis of conditional power assumptions in clinical trials with continuous or binary endpoints

Julia M. Edwards, Stephen J. Walters, Steven A. Julious

Patient-tailored transcranial direct current stimulation to improve stroke rehabilitation: study protocol of a randomized sham-controlled trial

Mia Kolmos, Mads Just Madsen, Marie Louise Liu, Anke Karabanov, Katrine Lyders Johansen, Axel Thielscher, Karen Gandrup, Henrik Lundell, Søren Fuglsang, Esben Thade, Hanne Christensen, Helle Klingenberg Iversen, Hartwig Roman Siebner, Christina Kruuse

Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trial

Claudina Rudolph, Beate Rikken Lindberg, Timothy Resch, Kevin Mani, Patrick Björkman, Elín Hanna Laxdal, Henrik Støvring, Henriette Margrethe Beck, Gunnar Eriksson, Jacob Budtz-Lilly

Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare): an updated study protocol for a parallel arm cluster randomised controlled trial

Carina King, Malini Pires, Naveed Ahmed, Kohenour Akter, Abdul Kuddus, Andrew Copas, Hassan Haghparast-Bidgoli, Joanna Morrison, Tasmin Nahar, Sanjit Kumer Shaha, AKAzad Khan, Kishwar Azad, Edward Fottrell

Leukocyte- and platelet-rich fibrin in cranial surgery: study protocol for a prospective, parallel-group, single-blinded randomized controlled non-inferiority trial {1}

Birgit Coucke, Anaïs Van Hoylandt, Johannes van Loon, Frank Van Calenbergh, Laura Van Gerven, Tom Theys

Promoting mental health and well-being in schools: examining mindfulness, relaxation and strategies for safety and well-being in English primary and secondary schools—study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)

Daniel Hayes, Anna Moore, Emily Stapley, Neil Humphrey, Rosie Mansfield, Joao Santos, Emma Ashworth, Praveetha Patalay, Eva-Maria Bonin, Sara Evans-Lacko, Bettina Moltrecht, Kirsty Nisbet, Emma Thornton, Aurelie Lange, Paul Stallard, Abigail Thompson, Jan Rasmus Boehnke, Jessica Deighton

Effect of focused power ultrasound-mediated perirenal fat modification on primary hypertension: protocol of a multicenter, randomized, double-blinded, sham-controlled study

Menghuan Li, Jing Shi, Yanhui Sheng, Yuqing Zhang, Tingting Wu, Jiaming Yang, Kerui Zhang, Wei Sun, Xiangqing Kong

HOPPSA update: changes in the study protocol of Hysterectomy and OPPortunistic SAlpingectomy, a registry-based randomized controlled trial

Annika Idahl, Per Liv, Anna Darelius, Elin Collins, Karin Sundfeldt, Mathias Pålsson, Annika Strandell

Development of core outcome sets of Food for Special Medical Purposes designed for type 2 diabetes mellitus: a study protocol

Dongyu Mu, Jie Gong, Yaoyao Wei, Muxi Chen, Jiajie Yu, Liang Du, Wen Hu

  • Open Access
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Suture-tape augmentation of anterior cruciate ligament reconstruction: a prospective, randomised controlled trial (STACLR)

Lachlan Huntington, Andrew Griffith, Libby Spiers, Rebecca Pile, Lachlan Batty, Scott Tulloch, Phong Tran

  • Open Access
  • Update

Serial prophylactic exchange blood transfusion in pregnant women with sickle cell disease (TAPS-2): statistical and qualitative analysis plan for a randomised controlled feasibility trial

Paul T. Seed, Sarah B. Brien, Laura L. Oakley, Vicky Robinson, Joseph Sharif, Hilary Thompson, Jeannine Joseph, Eugene Oteng-Ntim

  • Open Access
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Effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients (CONFIDENCE): protocol for a multicentre randomised controlled trial

Siebe G. Blok, Amne Mousa, Michelle G. Brouwer, Harm-Jan de Grooth, Ary Serpa Neto, Michiel J. Blans, Sylvia den Boer, Tom Dormans, Henrik Endeman, Timo Roeleveld, Harm Scholten, Eline R. van Slobbe-Bijlsma, Erik Scholten, Hugo Touw, Fleur Stefanie L. I. M. van der Ven, Evert-Jan Wils, David J. van Westerloo, Leo M. A. Heunks, Marcus J. Schultz, Frederique Paulus, Pieter R. Tuinman

The integration of rapid qualitative research in clinical trials: reflections from the ward-based goal-directed fluid therapy (GDFT) in acute pancreatitis feasibility trial

Cecilia Vindrola-Padros, Farid Froghi, Vignesh Gopalan, Sachan Maruthan, Helder Filipe, Margaret McNeil, Sara Mingo Garcia, Brian Davidson

  • Open Access
  • Commentary

Commentary on my personal experience of patient and public involvement in the TOPSY trial

Margaret Graham, Kirsteen Goodman

Arthroscopic synovectomy versus intra-articular injection of corticosteroids for the management of refractory psoriatic or rheumatoid arthritis of the wrist: study protocol for a randomized controlled trial (ARCTIC trial)

P. N. d’Ailly, C. Deugd, N. W. L. Schep, T. M. Kuijper, M. R. Kok, A. Willemze, J. H. Coert, P. H. P. de Jong, W. K. Lam-Tse, A. H. M. van der Helm-van Mil, I. Tchetverikov, A. E. A. M. Weel-Koenders, R. J. Bisoendial

Adjuvant melatonin for uveal melanoma (AMUM): protocol for a randomized open-label phase III study

Ruba Kal Omar, Anna Hagström, Gustav Stålhammar

  • Open Access
  • Care
  • Study protocol

Impact of corticosteroids on the duration of ventilatory support during severe acute exacerbations of chronic obstructive pulmonary disease in patients in the intensive care unit: a study protocol for a multicentre, randomized, placebo-controlled, double-blind trial

Alexis Ferré, Arnaud W. Thille, Armand Mekontso-Dessap, Thomas Similowski, Stéphane Legriel, Philippe Aegerter, Alexandre Demoule

  • Open Access
  • Study protocol

Study protocol for a randomized controlled trial of Proportional Assist Ventilation for Minimizing the Duration of Mechanical Ventilation: the PROMIZING study

Karen J. Bosma, Claudio M. Martin, Karen E. A. Burns, Jordi Mancebo Cortes, Juan Carlos Suárez Montero, Yoanna Skrobik, Kevin E. Thorpe, Andre Carlos Kajdacsy-Balla Amaral, Yaseen Arabi, John Basmaji, Gaëtan Beduneau, Francois Beloncle, Guillaume Carteaux, Emmanuel Charbonney, Alexandre Demoule, Martin Dres, Vito Fanelli, Anna Geagea, Ewan Goligher, François Lellouche, Tommaso Maraffi, Alain Mercat, Pablo O. Rodriguez, Jason Shahin, Stephanie Sibley, Savino Spadaro, Katerina Vaporidi, M. Elizabeth Wilcox, Laurent Brochard

  • Open Access
  • Commentary

Changing patient preferences toward better trial recruitment: an ethical analysis

Pepijn Al, Spencer Hey, Charles Weijer, Katie Gillies, Nicola McCleary, Mei-Lin Yee, Juliette Inglis, Justin Presseau, Jamie Brehaut

Chemoembolization combined radiofrequency ablation vs. chemoembolization alone for treatment of beyond the Milan criteria viable hepatocellular carcinoma (CERFA): study protocol for a randomized controlled trial

Soon Kyu Lee, Hyun Yang, Jung Hyun Kwon, Dong Jae Shim, Doyoung Kim, Soon Woo Nam, Sun Hong Yoo, Si Hyun Bae, Ahlim Lee, Young Joon Lee, Changho Jeon, Jeong Won Jang, Pil Soo Sung, Ho Jong Chun, Su Ho Kim, Joon-Il Choi, Jung Suk Oh, Yun-Jung Yang

  • Open Access
  • Study protocol

A structured, telephone-delivered intervention to reduce methamphetamine use: study protocol for a parallel-group randomised controlled trial

Dan I. Lubman, Victoria Manning, Shalini Arunogiri, Kate Hall, John Reynolds, Peta Stragalinos, Rachel Petukhova, Robyn Gerhard, Jonathan Tyler, Anna Bough, Anthony Harris, Jasmin Grigg

Study protocol for a randomised controlled trial to evaluate the use of melanoma surveillance photography to the Improve early detection of MelanomA in ultra-hiGh and high-risk patiEnts (the IMAGE trial)

Mabel K. Yan, Anne E. Cust, H. Peter Soyer, Monika Janda, Katja Loewe, Gabrielle Byars, Paul Fishburn, Paul White, Rashidul Alam Mahumud, Robyn P. M. Saw, Alan Herschtal, Pablo Fernandez-Penas, Pascale Guitera, Rachael L. Morton, John Kelly, Rory Wolfe, Victoria J. Mar

Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder

Samuel C. Peter, James G. Murphy, Katie Witkiewitz, Sarah B. Hand, Fridtjof Thomas, Karen Chandler Johnson, Ronald Cowan, Matt Harris, Karen J. Derefinko

  • Open Access
  • Opioids
  • Study protocol

A double-blinded, placebo-controlled, randomized study to evaluate the efficacy of perioperative dextromethorphan compared to placebo for the treatment of postoperative pain: a study protocol

Ian A. Jones, Amit S. Piple, Pui Yuk Yan, Donald B. Longjohn, Paul K. Gilbert, Jay R. Lieberman, Gligor V. Gucev, Daniel A. Oakes, Christina E. Ratto, Alexander B. Christ, Nathanael D. Heckmann

Randomized controlled trial protocol of health coaching for veterans with complex chronic pain

Sarah Crosky, Mikhaela McFarlin, Nicole Sullivan, Darren Winograd, David Litke, Robin M. Masheb, Shou-En Lu, Michelle Costanzo, Nicole Anastasides, Christina Gonzalez, Jaineel Doshi, Fiona Graff, Linda Khatib, Scott Thien, Lisa M. McAndrew

Effect of Remote Peer-Counsellor- delivered Behavioral Activation and Peer-support for Antenatal Depression on Gestational Age at Delivery: a single-blind, randomized control trial

Kathleen H. Chaput, Makayla Freeman, Carly McMorris, Amy Metcalfe, Emily E. Cameron, James Jung, Suzanne Tough, Laurel M. Hicks, Sona Dimidjian, Lianne M. Tomfohr-Madsen

Effects of a biomechanical-based Tai Chi program on gait and posture in people with Parkinson’s disease: study protocol for a randomized controlled trial

Nok-Yeung Law, Jing Xian Li, Qingguang Zhu, Julie Nantel

  • Open Access
  • Commentary

The importance of NOT being Other: Time to address the invisibility of nuanced gender and sexuality in clinical trials

Adam D. N. Williams, Kerenza Hood, Karen Bracken, Gillian W. Shorter

  • Open Access
  • Research

A DELPHI study priority setting the remaining challenges for the use of routinely collected data in trials: COMORANT-UK

Adam D. N. Williams, Gwyneth Davies, Amanda J. Farrin, Marion Mafham, Michael Robling, Matthew R. Sydes, Fiona V. Lugg-Widger

  • Open Access
  • Care
  • Methodology

Electronic health records to capture primary outcome measures: two case studies in HIV prevention research

David Dunn, Leanne McCabe, Ellen White, Valerie Delpech, Peter D. Kirwan, Jameel Khawam, Sara Croxford, Denise Ward, Elizabeth Brodnicki, Alison Rodger, Sheena McCormack

A randomised controlled trial assessing the potential of palmitoylethanolamide (PEA) to act as an adjuvant to resistance training in healthy adults: a study protocol

Zoya Huschtscha, Jackson J. Fyfe, Simon A. Feros, Andrew C. Betik, Christopher S. Shaw, Luana C. Main, Gavin Abbott, Sze-Yen Tan, Martin C. Refalo, Michael Gerhardy, Emma Grunwald, Anthony May, Jessica Silver, Craig M. Smith, Matthew White, D. Lee Hamilton

Clinical decision support to Optimize Care of patients with Atrial Fibrillation or flutter in the Emergency department: protocol of a stepped-wedge cluster randomized pragmatic trial (O’CAFÉ trial)

David R. Vinson, Adina S. Rauchwerger, Chandu A. Karadi, Judy Shan, E. Margaret Warton, Jennifer Y. Zhang, Dustin W. Ballard, Dustin G. Mark, Erik R. Hofmann, Dale M. Cotton, Edward J. Durant, James S. Lin, Dana R. Sax, Luke S. Poth, Stephen H. Gamboa, Meena S. Ghiya, Mamata V. Kene, Anuradha Ganapathy, Patrick M. Whiteley, Sean C. Bouvet, Leon Babakhanian, Edward W. Kwok, Matthew D. Solomon, Alan S. Go, Mary E. Reed

BISCIT: Biliary interventions in critically ill patients with secondary sclerosing cholangitis—a study protocol for a multicenter, randomized, controlled parallel group trial

Klaus Stahl, Friederike Klein, Torsten Voigtländer, Anika Großhennig, Thorsten Book, Tobias Müller, Alexander Wree, Armin Kuellmer, Jochen Weigt, Alexander Dechene, Edris Wedi, Arne Kandulski, Christian M. Lange, Dennis Holzwart, Dorothee von Witzendorff, Kristina I. Ringe, Heiner Wedemeyer, Benjamin Heidrich, Paul Schirmer, Henrike Lenzen, Ute Denkena, Christoph Schindler, Christian M. Lange

Evidence of secular trends during the COVID-19 pandemic in a stepped wedge cluster randomized trial examining sexual and reproductive health outcomes among Indigenous youth

Michael Anastario, Elizabeth Rink, Paula Firemoon, Nicole Carnegie, Olivia Johnson, Malory Peterson, Ana Maria Rodriguez

Effects of 10 Hz individualized repetitive transcranial magnetic stimulation on patients with disorders of consciousness: a study protocol for an exploratory double-blind crossover randomized sham-controlled trial

Chengwei Xu, Zhaohua Zhu, Wanchun Wu, Xiaochun Zheng, Haili Zhong, Xiyan Huang, Qiuyou Xie, Xinyi Qian

Lenient rate control versus strict rate control for atrial fibrillation: a statistical analysis plan for the Danish Atrial Fibrillation (DanAF) randomized clinical trial

Isak Mazanti Cold, Joshua Buron Feinberg, Axel Brandes, Ulla Davidsen, Ulrik Dixen, Helena Dominguez, Uffe Jakob Ortved Gang, Christian Gluud, Rakin Hadad, Kit Engedal Kristensen, Doan Tuyet van Le, Emil Eik Nielsen, Michael Hecht Olsen, Ole Dyg Pedersen, Ilan Esra Raymond, Ahmad Sajadieh, Anne Merete Boas Soja, Janus Christian Jakobsen

Coordinating smoking cessation treatment with menstrual cycle phase to improve quit outcomes (MC-NRT): study protocol for a randomized controlled trial

Laurie Zawertailo, Tina Kabir, Sabrina Voci, Elise Tanzini, Sophia Attwells, Liliana Malat, Scott Veldhuizen, Nadia Minian, Rosa Dragonetti, Osnat C. Melamed, Elad Mei-Dan, Peter Selby

IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a cluster randomised controlled implementation trial

Kirstie McClatchey, Vicky Hammersley, Liz Steed, Jessica Sheringham, Viv Marsh, Atena Barat, Brigitte Delaney, Thomas Hamborg, Deborah Fitzsimmons, Steve Holmes, Tracy Jackson, Elisabeth Ehrlich, Noelle Morgan, Ann Saxon, Megan Preston, David Price, Stephanie J. C. Taylor, Hilary Pinnock

  • Open Access
  • Study protocol

A cluster randomised, 16-week, parallel-group multicentre trial to compare the effectiveness of a digital school-based cognitive behavioural resilience/wellbeing-building intervention targeting emotional and behavioural problems in vulnerable Year 4 primary school children in whole classes, to the usual school curriculum: a study protocol to the “CUES for Schools” trial

S. Jolley, J. Lord, D. Plant, E. Wood, K. Bracegirdle, S. Browning, B. Carter, K. James

Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries

Kelsey McDonald, Earl Seltzer, Mary Lu, Stefan Diaz Gaisenband, Cassandra Fletcher, Patrick McLeroth, Kamal S Saini

  • Open Access
  • Opioids
  • Study protocol

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial

Ronald G. Thompson Jr., Mary Bollinger, Michael J. Mancino, Deborah Hasin, Xiaotong Han, Keith A. Bush, Clint D. Kilts, G. Andrew James

Unicompartmental knee arthroplasty vs. high tibial osteotomy for medial knee osteoarthritis (UNIKORN): a study protocol of a randomized controlled trial

Juuso Siren, Lasse Rämö, Mikko Rantasalo, Olli Komulainen, Noora Skants, Aleksi Reito, Jussi Kosola, Jan Lindahl

  • Open Access
  • Malaria
  • Study protocol

Dihydroartemisinin-piperaquine or sulphadoxine-pyrimethamine for the chemoprevention of malaria in children with sickle cell anaemia in eastern and southern Africa (CHEMCHA): a protocol for a multi-centre, two-arm, double-blind, randomised, placebo-controlled superiority trial

Thandile Nkosi-Gondwe, Bjarne Robberstad, Robert Opoka, Dennis Kalibbala, Joseph Rujumba, Lufina Tsirizani Galileya, Pamela Akun, Winnie Nambatya, John Ssenkusu, Feiko TerKuile, Kamija Phiri, Richard Idro

Liver-HERO: hepatorenal syndrome-acute kidney injury (HRS-AKI) treatment with transjugular intrahepatic portosystemic shunt in patients with cirrhosis—a randomized controlled trial

Cristina Ripoll, Stephanie Platzer, Philipp Franken, Rene Aschenbach, Andreas Wienke, Ulrike Schuhmacher, Ulf Teichgräber, Andreas Stallmach, Jörg Steighardt, Alexander Zipprich, Philipp Reuken, Marina Reljic, Florian Bürckenmeyer, Kathleen Lange, Robin Greinert, Marco Damm, Christian Lange, Paul Jamme, Max Seidensticker, Moritz Wildgruber, Dominik Bettinger, Michael Schultheiss, Marco Berning, Stefan Sulk, Jens-Peter Kühn, Ralf-Thorsten Hoffmann, Christoph Radosa, Thomas Hofmockel, Tony Bruns, Theresa Wirtz, Philipp Bruners, Karel Caca, Andreas Wannhoff, Benjamin Massoumy, Katja Deterding, Jan Hinrichs, Kerstin Port, Jonel Trebicka, Michael Praktiknjo, Cornelius Engelmann, Andreas Drolz

Strategies to minimise and monitor biases and imbalances by arm in surgical cluster randomised trials: evidence from ChEETAh, a trial in seven low- and middle-income countries

Didier Ahogni, Aristide Ahounou, K. Alassan Boukari, Oswald Gbehade, Thierry K. Hessou, Sinama Nindopa, M. J. Bienvenue Nontonwanou, Nafissatou Orou Guessou, Arouna Sambo, Sorekou Victoire Tchati, Affisatou Tchogo, Semevo Romaric Tobome, Parfait Yanto, Isidore Gandaho, Armel Hadonou, Simplice Hinvo, Montcho Adrien Hodonou, Sambo Bio Tamou, Souliath Lawani, Covalic Melic Bokossa Kandokponou, Francis Moise Dossou, Antoine Gaou, Roland Goudou, Marie-Claire Kouroumta, Ismail Lawani, Enrif Malade, Anne Stredy Mkoh Dikao, Joel Nzuwa Nsilu, Pencome Ogouyemi, Marcelin Akpla, Nathan Bisimwa Mitima, Blaise Kovohouande, Cyrille Kpangon, Stephane Laurent Loupeda, Mamonde Victorin Agbangla, Sena Emmanuel Hedefoun, Thierry Mavoha, Juvenal Ngaguene, Janvier Rugendabanga, Rish Romaric Soton, Martin Totin, Mouhamed Agbadebo, Irene Akpo, Hubert Dewamon, Martin Djeto, Aissatou Hada, Monsede Hollo, Albert Houndji, Anasthasie Houndote, Sylvestre Hounsa, Expedit Kpatchassou, Hugues Yome, Mohamed Moussa Alidou, Eric Jerry Bara, B. T. Bonheur Dossou Yovo, Robert Guinnou, Souleymane Hamadou, H. Pauline Kola, Nabil Moussa, Boniface Cakpo, Lolyta Etchisse, Emery Hatangimana, Moise Muhindo, Katia Sanni, Agossou Barthelemy Yevide, Hermann Agossou, Fiston Basirwa Musengo, Hulrich Behanzin, Djifid Morel Seto, Bill Armstrong Alia, Arnaud Alitonou, Y. Edith Mehounou, Lucien Agbanda, Julien Attinon, Marcel Gbassi, Nounagnon Rene Hounsou, Regina Acquah, Charles Banka, Derick Esssien, Romeo Hussey, Yakubu Mustapha, Kojo Nunoo-Ghartey, Grace Yeboah, Luke A. Aniakwo, Margarey N. M. Adjei, Yvonne Adofo-Asamoah, Meshach M. Agyapong, Thomas Agyen, Baba A. B. Alhassan, Mabel P. Amoako-Boateng, Anthony Baffour Appiah, Josephine Ashong, Joseph K. Awindaogo, Benjamin B. Brimpong, Makafui S. C. J. K. Dayie, Donald Enti, Wendy W. Ghansah, Jude E. Gyamfi, Patience Koggoh, Richard Kpankpari, Vincent Kudoh, Samuel Mensah, Philip Mensah, Isabella N. Morkor Opandoh, Martin T. Morna, Michael Nortey, Emelia Odame, Emmanuel O. Ofori, Sandra Quaicoo, Elizabert M. Quartson, Cynthia Teye-Topey, Makafui Yigah, Safia Yussif, Esther Adjei-Acquah, Vera O. Agyekum-Gyimah, Eric Agyemang, Arko Akoto-Ampaw, Forster Amponsah-Manu, Temitope E. Arkorful, Moses A. Dokurugu, Nanabanyin Essel, Aja Ijeoma, Emmanuel L. Obiri, Richard Ofosu-Akromah, Karen N. D. Quarchey, Leslie Adam-Zakariah, Aaron B. Andoh, Esther Asabre, Ruby A. Boateng, Barbara Koomson, Atta Kusiwaa, Adeline Naah, Ato Oppon-Acquah, Benjamin A. Oppong, Emma A. Agbowada, Ameley Akosua, Ralph Armah, Christopher Asare, Lawrence K. B. Awere-Kyere, Amanda Bruce-Adjei, Nana Ama Christian, Delali A. Gakpetor, Korankye K. Kennedy, Jacqueline Mends-Odro, Ambe Obbeng, Doris Ofosuhene, Dorcas Osei-Poku, Zelda Robertson, Dorcas O. Acheampong, Jane Acquaye, Juliana Appiah, Joshua Arthur, Jonathan Boakye-Yiadom, Anita Eseenam Agbeko, Frank E. Gyamfi, Bertina B. Nyadu, Samira Abdulai, Nii A. Adu-Aryee, Nelson Agboadoh, Erica Akoto, Joachim K. Amoako, Nicholas T. Aperkor, Wilfred K. Asman, Godsway S. Attepor, Antoinette A. Bediako-Bowan, Kwaku Boakye-Yiadom, George D. Brown, Florence Dedey, Victor K. Etwire, Benjamin S. Fenu, Philemon K. Kumassah, Linda A. Larbi-Siaw, Josephine Nsaful, David O. Olatola, Sandra E. Tsatsu, Theodore Wordui, Iddrisu I. A. Abdul-Aziz, Fatao Abubakari, Johnson Akunyam, Gilbert A. G. Anasara, Cletus Ballu, Charles G. Barimah, Guy C. Boateng, Ponala W. Kwabena, Seidu M. Kwarteng, Prosper T. Luri, Kennedy Ngaaso, David K. D. Ogudi, Vivian Adobea, Amos Bennin, Stanley Doe, Ruth Sarfo Kantanka, Ephraim Kobby, Collins Kyeremeh, Edwin Osei, Prince Yeboah Owusu, Frank Owusu, Clement Sie-Broni, Marshall Zume, Saba Abdul-Hafiz, Daniel K. Acquah, Shamsudeen M. Adams, Mohammed S. Alhassan, Munira Amadu, Samuel A. Asirifi, Martin Awe, Millicent Azanlerigu, Mathias K. Dery, Yenli Edwin, Abantanga Atindaana Francis, Gbana Limann, Aloysius Maalekuu, Hawa Malechi, Sheriff Mohammed, Ibrahim Mohammed, Kareem Mumuni, Bernard A. Ofori, Jonathan I. K. Quansah, Anwar S. Seidu, Stephen Tabiri, Shekira Yahaya, Emmanuel Kojo Acquah, Jaabir Alhassan, Percy Boakye, Christian L. Coompson, Addo K. Gyambibi, Ametepe Jeffery-Felix, Bismark E. Kontor, Ruth Manu, Elijah Mensah, Gifty Naah, Carmen Noufuentes, Abraham Sakyi, Ramkaran Chaudhary, Sanjeev Misra, Puneet Pareek, Manish Pathak, Dharma R. Poonia, Kirti K. Rathod, Mahaveer S. Rodha, Naveen Sharma, Nivedita Sharma, Subhash C. Soni, Vaibhav K. Varsheney, Jeevan R. Vishnoi, Deepak K. Garnaik, Farhanul Huda, Manoj J. Lokavarapu, Neha Mishra, Rohit Ranjan, Rajkumar K. Seenivasagam, Shanky Singh, Pratik Solanki, Raunak Verma, Enono Yhoshu, Suzan John, Jeffery A. Kalyanapu, Ananta Kutma, Sanish Philips, Arun K. Gautham, Alice Hepzibah, Grace Mary, Deepak S. Singh, Eunice S. Abraham, Chetana Chetana, Amos Dasari, Prashant Dummala, Chinta S. Gold, Jurgen Jacob, Jeremiah N. Joseph, Elizabeth N. Kurien, Priya Mary, Arpit J. Mathew, Amy E. Mathew, Danita D. Prakash, Oliver Samuel, Ashwin Sukumar, Niyah Syam, Rose Varghese, Alisha Bhatt, William Bhatti, Tapasya Dhar, Dhruva N. Ghosh, Ankush Goyal, Sunita Goyal, Monika A. Hans, Parvez D. Haque, Deepak Jain, Rita Jain, Jyoti Jyoti, Savleen Kaur, Karan Kumar, Anil Luther, Amit Mahajan, Kavita Mandrelle, Vishal Michael, Partho Mukherjee, Reuben Rajappa, Vivin Daniel Sam, Prashant Singh, Atul Suroy, Ravinder Singh Thind, Sreejith K. Veetil, Rahul Williams, D. Sreekar, Esther R. Daniel, Smitha E. Jacob, Mark R. Jesudason, Pushplatha Kumari, Rohin Mittal, Soosan Prasad, Vasanth Mark Samuel, Bharat Shankar, Srujan Sharma, Moonish V. Sivakumar, Suraj Surendran, Anita Thomas, Paul Trinity, Sudheer Kanchodu, K. Leshiini, Sundeep S. Saluja, Ashok K. Attri, Ishan Bansal, Sanjay Gupta, Monika Gureh, Simran Kapoor, Manisha Aggarwal, Vinoth Kanna, Harmanjot Kaur, Ashwani Kumar, Simrandeep Singh, Gurtaj Singh, Viju John, Mohammed Adnan, Nivesh Agrawal, Uttkarsh Kumar, Pardeep Kumar, S. Abhishek, Vikram Sehrawat, Deepak Singla, Gaurav Thami, Vijay Kumar, Stanley Mathew, Murlidhar V. Pai, P. S. Prabhu, P. T. Sundeep, Naseem Akhtar, Arun Chaturvedi, Sameer Gupta, Vijay Kumar, Puneet Prakash, Shiv Rajan, Mohit Singh, Abhilasha Tripathi, Philip V. Alexander, Josy Thomas, Pradeep Zechariah, Vijay A. Ismavel, Moloti Kichu, Carolin V. Solomi, Rahul A. Alpheus, Ashish Victor Choudhrie, Rashmi Jacob Gunny, Susan Joseph, Muneer A. Malik, Nitin J. Peters, Neha Pundir, Ram Samujh, Hafsa I. Ahmed, Gowhar Aziz, Nisar A. Chowdri, Rayees A. Dar, Robindera Kour, Imtiyaz Mantoo, Asif Mehraj, Fazl Q. Parray, Najmus Saqib, Zamir A. Shah, Rauf A. Wani, Subrat Raul, Komal Rautela, Rajeev Sharma, Nishu Singh, Rakesh Vakil, Priyanka Chowdhury, Sona Chowdhury, Sonia Mathai, Pragyanmai Nayak, Bipradas Roy, Andrea S. Alvarez Villaseñor, Kriscia V. Ascencio Díaz, Victor J. Avalos Herrera, Francisco J. Barbosa Camacho, Aldo Bernal Hernández, Elyoenai Bonilla Ahumada, Irma V. Brancaccio Pérez, Miguel A. Calderón Llamas, Guadalupe Castillo Cardiel, Guillermo A. Cervantes Cardona, Gabino Cervantes Guevara, Enrique Cervantes Perez, Maria Chávez, Jonathan M. Chejfec Ciociano, Luis R. Cifuentes Andrade, Ana O. Cortés Flores, Edgar J. Cortes Torres, Tania A. Cueto Valadez, Andrea E. Cueto Valadez, Esteban Cueva Martinez, Paulina Domínguez Barradas, Isaac Esparza Estrada, Paola Flores Becerril, Jose A. Flores Cardoza, Clotilde Fuentes Orozco, Luis A. García González, Benjamín García Reyna, Eduardo Gómez Sánchez, Jaime L. González Bojorquez, Eduardo González Espinoza, Alejandro González Ojeda, Fanny Y. González Ponce, Cristhian S. Guerrero Ramírez, José A. Guzmán Barba, Bertha G. Guzmán Ramírez, Mario J. Guzmán Ruvalcaba, Daniel A. Hérnandez Alva, Silvia A. Ibarra Camargo, Juan C. Ibarrola Peña, Martin Islas Torres, Jorge Jiménez Tornero, Zayra M. Lara Pérez, Roberto Mares País, Mel P. Mellado Tellez, Roberto C. Miranda Ackerman, Damián Mora Santana, Gilberto Morgan Villela, Rodrigo Nájar Hinojosa, Cesar Nuño Escobar, Itzel Ochoa Rodríguez, Oscar Olvera Flores, Angelica Ortega Barreiro, Jacqueline Osuna Rubio, Luis R. Pacheco Vallejo, Víctor H. Pérez Bocanegra, Jose V. Pérez Navarro, Francisco J. Plascencia Posada, María A. Quirarte Hernández, Luis R. Ramirez Gonzalez, Emilio A. Reyes Elizalde, Evelia V. Romo Ascencio, Cornelio Ruelas Bravo, Carlos B. Ruiz Velasco, José A. Sánchez Martínez, Guillermo Sanchez Villaseñor, José I. Sandoval Pulido, Alejandro G. Serrano García, Luis O. Suárez Carreón, Juan J. Tijerina Ávila, Jesus O. Vega Gastelum, Melissa L. Vicencio Ramirez, Maria F. Zarate Casas, Carlos J. Zuloaga Fernández del Valle, Jesus Antonion Aguilar Mata, Miguel Antonio Calderon Vanegas, Rocio Guadalupe Cano Arias, Carlos Colunga Tinajero, Fernanda Diaz Samano, Fernando Duque Zepeda, Brenda Vanessa Enriquez Barajas, Gerardo Gallardo Banuelos, Marijose De Cristo Gonzalez Calvillo, Francisco Ibanez Ortiz, Maryzela Lazo Ramirez, Gerardo Lopez Arroyo, Laura Olivia Montano Angeles, David Giovanny I. Morales Iriarte, Angelo Fernando Mortola Lomeli, Jose Esteban Orozco Navarro, Jaime Orozco Perez, Damaris Orozco Ramirez, Laura Gabriela Pena Baolboa, Jesus Pizarro Lozano, Guillermo Yanowsky Reyes, Monica N. Castillo, Ana Camille G. Dominguez, Dorihela H. Mellado, Jesus Flavio M. Morales, Luz del Carmen H Namur, Jose Alberto A. Pesquera, Laura Martinez Perez Maldonado, Antonio Ramos De la Medina, Katya Bozada-Gutierrez, Ana Florencia Casado-Zarate, Roberto Delano-Alonso, Jose Herrera-Esquivel, Mucio Moreno-Portillo, Mario Trejo-Avila, Roland Kevin Cethorth Fonseca, Edgard Efren Lozada Hernandez, Bruno Crocco Quiros, Jairo Arturo Rodriguez Ramirez, Gabriela Ambriz-González, Mitzi R. Becerra Moscoso, Ishtar Cabrera-Lozano, Ana B. Calderón-Alvarado, Francisco J. León-Frutos, Erick E. Villanueva-Martínez, Aisha Abdullahi, Maimuna Abubakar, Mohammed S. Aliyu, Mudi Awaisu, Fadimatu Bakari, Abigail Olajumoke Balogun, Mohammed Bashir, Ahmad Bello, Muhammad Daniyan, Kehinde Michael Duromola, Stephen G. Gana, Mukoro Duke George, Justina Gimba, Isaac Gundu, Lambert Onahi Iji, Aminat O. Jimoh, Afolabi K. Koledade, Ahmad T. Lawal, Bilkisu  K Lawal, Aisha Mustapha, Stanley Emeka Nwabuoku, Oluseyi O. Ogunsua, Ifeanyi Fidelis Okafor, Ethos Ike Okorie, Nasir Oyelowo, Ibrahim A. Saidu, Tunde T. Sholadoye, Ibrahim Sufyan, Musliu Adetola Tolani, Aliyu Muhammad Tukur, Ahmad Shehu Umar, Aminatu M. Umar, Hajara Umaru-Sule, Mohammed Usman, Anisah Yahya, Alfa Yakubu, Salisu Abeku Yusuf, Abdulhafiz A. Abdulkarim, Lawal Barau Abdullahi, Muzzammil Abdullahi, Khadija A. Ado, Nura U. Aliyu, Lofty-John Chukwuemeka Anyanwu, Sulaiman M. Daneji, Mahmoud Kawu Magashi, Mohammad A. Mohammad, Abubakar Bala Muhammad, Saminu S. Muhammad, Bello Abodunde Muideen, Calistus U. Nwachukwu, Suleiman B. Sallau, Abdulrahman A. Sheshe, Abdulmajeed Soladoye, Idris Usman Takai, Garzali I. Umar, Abubakar Yahaya, Lubabatu Abdulrasheed, Joel A. Adze, Lydia R. Airede, Bashiru Aminu, Stephen B. Bature, Firdaws Bello-Tukur, Damai Chinyio, Sharon A. N. Duniya, Moses C. Galadima, Babatunde K. Hamza, Samaila Joshua, Stephen A. Kache, Williams Y. Kagomi, Ifeanyi A. Kene, Jamila Lawal, Jerry G. Makama, Caleb Mohammed, Amina A. Mohammed-Durosinlorun, Deborah Nuwam, Danjuma Sale, Abdulrasheed Sani, Salome Tabara, Mathew C. Taingson, Emmanuel Usam, Josiah Yakubu, Folasade Adegoke, Oluwasuyi Ige, Tunde A. Odunafolabi, Chukwuma E. Okereke, Oluwafemi O. Oladele, Oluwaseun H. Olaleye, Oyetunde O. Olubayo, Olukayode P. Abiola, Henry O. Abiyere, Idowu O. Adebara, Gbadebo T. C. Adeleye, Adebayo A. Adeniyi, Olumide E. Adewara, Olabisi T. Adeyemo, Ademola A. Adeyeye, Abimbola L. Ariyibi, Babatunde S. Awoyinka, Olumide M. Ayankunle, Olakunle F. Babalola, Adewumi Bakare, Tajudeen I. B. Bakare, Oluseyi O. Banjo, Peter A. Egharevba, Oluwafemi S. Fatudimu, John A. Obateru, Oluremi J. Odesanya, Owolabi D. Ojo, Abiodun I. Okunlola, Cecilia K. Okunlola, Adewale T. Olajide, Tesleem O. Orewole, Adedayo I. Salawu, Moruf A. Abdulsalam, Aderinsola T. Adelaja, Olalekan T. Ajai, Olukemi Akande, Noble Anyanwu, Kazeem M. Atobatele, Oludayo Oluwaseyi Bakare, Grace Eke, Omolara M. Faboya, Zainab O. Imam, Francisca C. Nwaenyi, Ayokunle A. Ogunyemi, Mobolaji A. Oludara, Olufunmilade A. Omisanjo, Chinonso U. Onyeka, Olabode A. Oshodi, Yusuf A. Oshodi, Yemisi Oyewole, Omotade S. Salami, Omolara M. Williams, Esther Abunimye, Adesoji O. Ademuyiwa, Adebunmi Adeoluwa, Adedotun Adesiyakan, Victoria Ibukunoluwa Adeyeye, Moses Vincent Agbulu, Opeyemi Rebecca Akinajo, David O. Akinboyewa, Felix M. Alakaloko, Iyabo O. Alasi, Michael Amao, Christiana Ashley-Osuzoka, Oluwole A. Atoyebi, Olanrewaju S. Balogun, Christopher O. Bode, Maryam Oluwatobi Busari, Nnamdi Jonathan Duru, Glory Bassey Edet, Olumide A. Elebute, Francis Chinonso Ezenwankwo, Adedeji L. Fatuga, Christianah Gbenga-Oke, George C. Ihediwa, Emmanuel Sylvester Inyang, Adesola I. Jimoh, Jubril Oladayo Kuku, Oluwaseun A. Ladipo-Ajayi, Abdulrazzaq O. Lawal, Ayomide Makanjuola, Christian Chigoze Makwe, Chinelo Victoria Mgbemena, Samuel U. Nwokocha, Moses Adebisi Ogunjimi, Ephraim Okwudiri Ohazurike, Rufus W. Ojewola, Moyosoluwa Eunice Badedale, Chike J. Okeke, Adeyemi A. Okunowo, Abraham T. Oladimeji, Thomas O. Olajide, Olabisi Olanrewaju, Olawunmi Olayioye, Oluwaseun O. Oluseye, Stephen Olutola, Kenneth Onyekachi, Adeola Ayoola Orowale, Emili Osariemen, Adedapo Olumide Osinowo, Benedetto Osunwusi, Emmanuel Owie, Christianah Bidemi Oyegbola, Justina O. Seyi-Olajide, Adaiah P. Soibi-Harry, Manuella Talla Timo, Aloy Okechukwu Ugwu, Emmanuel Ojo Williams, Innocent O. Duruewuru, Ochonma A. Egwuonwu, Okechukwu Hyginus Ekwunife, James J. Emeka, Victor Ifeanyichukwu Modekwe, Chimdiebele Daisy Nwosu, Sylvester O. Obiechina, Ahuizechukwu E. Obiesie, Celestine I. Okafor, Theophilus O. Okonoboh, Chukwuemeka Okoro, Odili A. Okoye, Onyekachi A. Onu, Chukwudubem C. Onyejiaka, Chisom Faith Uche, Joseph O. Ugboajah, Jideofor Okechukwu Ugwu, Kenneth Ugwuanyi, Chuka Ugwunne, Akeem A. Adeleke, Akinfolarin C. Adepiti, Adewale A. Aderounmu, Abdulhafiz O. Adesunkanmi, Adewale O. Adisa, Samuel C. Ajekwu, Olusegun K. Ajenifuja, Olusegun I. Alatise, Tajudeen A. Badmus, Tajudeen O. Mohammed, Olalekan Olasehinde, Abdulkadir A. Salako, Oludayo A. Sowande, Ademola O. Talabi, Funmilola O. Wuraola, Paul Aderemi Adegoke, Abidemi Akinloye, Ayodeji Akinniyi, Joseph Ejimogu, Ideyonbe Samuel Eseile, Olakayode Olaolu Ogundoyin, Amos Okedare, Dare Isaac Olulana, Omolara Omotola, Francis Sanwo, Collins C. Adumah, Adewale O. Ajagbe, Olugbenga P. Akintunde, Opeyemi Q. Asafa, Kehinde Awodele, Amogu K. Eziyi, Adeniyi O. Fasanu, Olufemi O. Ojewuyi, Abiodun R. Ojewuyi, Abisola E. Oyedele, Oluwaseun A. Taiwo, Habiba I. Abdullahi, Nathaniel D. Adewole, Teddy E. Agida, Eunice E. Ailunia, Oseremen Aisuodionoe-Shadrach, Godwin O. Akaba, Janet Alfred, Terkaa Atim, Kehinde G. Bawa, John Y. Chinda, Esther B. Daluk, Sefiu B. Eniola, Augusta O. Ezenwa, Stephen E. Garba, Ndubuisi Mbajiekwe, Philip M. Mshelbwala, Ngozi O. Ndukwe, Idoko P. Ogolekwu, Alexander A. Ohemu, Samson Olori, Olabisi O. Osagie, Samuel A. Sani, Salisu Suleiman, Helen Sunday, Nancy O. Tabuanu, Aminu M. Umar, Peter I. Agbonrofo, Alexander I. Arekhandia, Morrison E. Edena, Raymond A. Eghonghon, Joel E. Enaholo, Genesis Ida, Stanley N. Ideh, Oseihie I. Iribhogbe, Omorodion O. Irowa, Maradona E. Isikhuemen, Oluwatomi R. Odutola, Kester O. Okoduwa, Scott O. Omorogbe, David Oruade, Osasumwen T. Osagie, Osarenkhoe Osemwegie, Rukiyat A. Abdus-Salam, Sikiru Adekola Adebayo, Oluwasanmi A. Ajagbe, Akinlabi E. Ajao, Gboyega Ajibola, Omobolaji O. Ayandipo, Kelvin I. Egbuchulem, Hyginus O. Ekwuazi, Peter Elemile, Adegbolahan Fakoya, Oluwasegun C. Idowu, David O. Irabor, Taiwo A. Lawal, Olatunji O. Lawal, Olakayode O. Ogundoyin, Oluwabukade Ojediran, Naomi Olagunju, Akinsola T. Sanusi, Augustine O. Takure, Lukman Olajide Abdur-Rahman, Mary Oluwadamilola Adebisi, Nurudeen Abiola Adeleke, Rafiat Tinuola Afolabi, Isiaka Ishola Aremu, Jibril Oyekunle Bello, Robiat Bello, Abdulwahab Lawal, Saheed Abolade Lawal, Adeolu Ojajuni, Sabur Oyewale, Hadijat Olaide Raji, Olayinka Sayomi, Asimiyu Shittu, Victor Abhulimen, Patrick O. Igwe, Ikechukwu Enyinnaya Iweha, Raphael E. John, Nnyonno Okoi, Philemon E. Okoro, Vaduneme Kingsley Oriji, Ibiene T. Oweredaba, Japhet Mizero, Immaculee Mutimamwiza, Francoise Nirere, Irenee Niyongombwa, Jean Paul Majyabere, Anastase Byaruhanga, Rongin Dukuzimana, Jean Aimable Habiyakare, Marie Gloriose Nabada, Marcel Uwizeye, Mathias Ruhosha, Joselyne Igiraneza, Faustine Ingabire, Aloys Karekezi, Jean Pierre Masengesho, Christophe Mpirimbanyi, Lydia Mukamazera, Clemence Mukangabo, Jean Paul Niyomuremyi, Gabriel Ntwari, Celestin Seneza, Divine Umuhoza, Sosthene Habumuremyi, Alphonsine Imanishimwe, Salathiel Kanyarukiko, Francine Mukaneza, Deborah Mukantibaziyaremye, Aphrodis Munyaneza, Gibert Ndegamiye, Pierrine Nyirangeri, Ronald Tubasiime, Jean Claude Uwimana, Moses Dusabe, Emelyne Izabiriza, Hope Lydia Maniraguha, Christophe Mpirimbanyi, Josiane Mutuyimana, Olivier Mwenedata, Elisee Rwagahirima, Job Zirikana, Isaie Sibomana, Desire Rubanguka, Josine Umuhoza, Roda Uwayezu, Leoncie Uzikwambara, Aime Dieudonne Hirwa, Elysee Kabanda, Salomee Mbonimpaye, Christine Mukakomite, Piolette Muroruhirwe, Herbert Butana, Moise Dusabeyezu, Athanasie Mukasine, Jean N. Utumatwishima, Mediatrice Batangana, Georges Bucyibaruta, Sosthene Habumuremyi, Jean de Dieu Haragirimana, Alphonsine Imanishimwe, Allen J. C. Ingabire, Violette Mukanyange, Emmanuel Munyaneza, Emmanuel Mutabazi, Espoir Mwungura, Isaie Ncogoza, Faustin Ntirenganya, Jeannette Nyirahabimana, Dancilla Nyirasebura, Christian Jean Urimubabo, Anaclet Dusabimana, Sam Kanyesigye, Robert Munyaneza, Jean Yves Shyirakera, Maria Fourtounas, Mary Augusta Adams, Chikwendu Jeffrey Ede, Gabriella Hyman, Mpho Nosipho Mathe, Rachel Moore, Ncamsile Anthea Nhlabathi, Hlengiwe Samkelisiwe Nxumalo, Nnosa Sentholang, Mmule Evelyn Sethoana, Paul Wondoh, Zain Ally, Aimee Domingo, Philip Munda, Chido Nyatsambo, Victor Ojo, Rudo Pswarayi

Individual psychotherapy for cluster-C personality disorders: protocol of a pragmatic RCT comparing short-term psychodynamic supportive psychotherapy, affect phobia therapy and schema therapy (I-FORCE)

Martine Daniëls, Henricus L. Van, Birre van den Heuvel, Jack J. M. Dekker, Jaap Peen, Judith Bosmans, Arnoud Arntz, Marcus J. H. Huibers

The HAVEN study—hydroxychloroquine in ANCA vasculitis evaluation—a multicentre, randomised, double-blind, placebo-controlled trial: study protocol and statistical analysis plan

Annastazia E. Learoyd, Lauren Arnold, Fiona Reid, Nicholas Beckley-Hoelscher, Alina Casian, Shirish Sangle, Neil Morton, Louise Nel, Angela Cape, Susan John, Sangmi Kim, Dharshene Shivapatham, Raashid Luqmani, David Jayne, James Galloway, Abdel Douiri, David D’Cruz

The Canadian Healthy Life Trajectories Initiative (HeLTI) Trial: a study protocol for monitoring fidelity of a preconception-lifestyle behaviour intervention

Cindy-Lee Dennis, Flavia Marini, Alessandra Prioreschi, Justine Dol, Catherine Birken, Rhonda C. Bell

  • Open Access
  • Commentary

Specific recommendations to improve the design and conduct of clinical trials

Mark J. Kupersmith, Nathalie Jette

  • Open Access
  • Opioids
  • Study protocol

COMMunity of Practice And Safety Support for Navigating Pain (COMPASS-NP): study protocol for a randomized controlled trial with home care workers

Ryan Olson, Jennifer A. Hess, Dennis Turk, Miguel Marino, Leah Greenspan, Lindsey Alley, Courtney Donovan, Sean P.M. Rice

  • Open Access
  • Care
  • Study protocol

Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study

E. A. Adejuyigbe, I. Agyeman, P. Anand, H. C. Anyabolu, S. Arya, E. N. Assenga, S. Badhal, N. W. Brobby, H. K. Chellani, N. Chopra, P. K. Debata, Q. Dube, T. Dua, L. Gadama, R. Gera, C. K. Hammond, S. Jain, F. Kantumbiza, K. Kawaza, E. N. Kija, P. Lal, M. Mallewa, M. K. Manu, A. Mehta, T. Mhango, H. E. Naburi, S. Newton, I. Nyanor, P. A. Nyako, O. J. Oke, A. Patel, G. Phlange-Rhule, R. Sehgal, R. Singhal, N. Wadhwa, A. B. Yiadom

Effect of EIT-guided PEEP titration on prognosis of patients with moderate to severe ARDS: study protocol for a multicenter randomized controlled trial

Xueyan Yuan, Rui Zhang, Yuxuan Wang, Dongyu Chen, Yali Chao, Jingyuan Xu, Lanqi Guo, Airan Liu, Jianfeng Xie, Chun Pan, Yi Yang, Haibo Qiu, Ling Liu

SupportPrim—a computerized clinical decision support system for stratified care for patients with musculoskeletal pain complaints in general practice: study protocol for a randomized controlled trial

Lars Christian Naterstad Lervik, Ottar Vasseljen, Bjarne Austad, Kerstin Bach, Anita Formo Bones, Fredrik Granviken, Jonathan C. Hill, Pål Jørgensen, Torbjørn Øien, Paola Marin Veites, Danielle A. Van der Windt, Ingebrigt Meisingset

Effects of prebiotic supplement on gut microbiota, drug bioavailability, and adverse effects in patients with colorectal cancer at different primary tumor locations receiving chemotherapy: study protocol for a randomized clinical trial

Ya Chen, Xiaowei Liao, Yanmin Li, Hong Cao, Feng Zhang, Bojian Fei, Chuanqing Bao, Huaxiang Cao, Yong Mao, Xiaoping Chen, Xiang Gao, Wei Zhao, Jianmin Xu

Internet-delivered cognitive behavioral therapy for tinnitus compared to Internet-delivered mindfulness for tinnitus: a study protocol of a randomized controlled trial

Jonas Eimontas, Goda Gegieckaitė, Irena Asačiova, Nikol Stičinskaitė, Livija Arcimavičiūtė, Dovilė Savickaitė, Donata Vaitiekūnaitė-Zubriakovienė, Marius Polianskis, Jennifer Gans, Eldre Beukes, Vinaya Manchaiah, Gerhard Andersson, Eugenijus Lesinskas

  • Open Access
  • Study protocol

Reverse shoulder arthroplasty versus hemiarthroplasty versus non-surgical treatment for older adults with acute 3- or 4-part fractures of the proximal humerus: study protocol for a randomised controlled trial (PROFHER-2: PROximal Fracture of Humerus Evaluation by Randomisation – Trial Number 2)

Amar Rangan, Stephen Gwilym, Ada Keding, Belen Corbacho, Lucksy Kottam, Catherine Arundel, Elizabeth Coleman, Livio DiMascio, Catherine Hewitt, Valerie Jones, Jamila Kassam, Catriona McDaid, Natasha Mitchell, Andrew Mott, Grace O’Carroll, Puvan Tharmanathan, David Torgerson

Impact of the COVID-19 pandemic on a clinical trial of pneumococcal vaccine scheduling (PVS) in rural Gambia

Ilias Hossain, Isaac Osei, Galega Lobga, Baleng M. Wutor, Yekini Olatunji, Williams Adefila, Banjo Adeshola, Yasir Isa, Cattram Nguyen, Kemo Sonko, Lamin Ceesay, Bubacarr Baldeh, Omar Barrow, Benjamin Young, Saidina Ceesay, Abdoullah Nyassi, Golam Sarwar, Ousman Barjo, Momodou M.Drammeh, Rasheed Salaudeen, Grant Mackenzie

  • Open Access
  • Study protocol

Efficacy of selenium supplementation for mild-to-moderate Graves’ ophthalmopathy in a selenium-sufficient area (SeGOSS trial): study protocol for a phase III, multicenter, open-label, randomized, controlled intervention trial

Chae Won Chung, Kyong Yeun Jung, Eun Hye Jung, Min Joung Lee, Young Joo Park, Jeong Kyu Lee, Hwa Young Ahn, Sun Wook Cho

  • Open Access
  • Study protocol

Arthroscopic versus open cancellous bone grafting for scaphoid delayed/nonunion in adults (SCOPE-OUT): study protocol for a randomized clinical trial

Morten Kjaer, Jeppe Vejlgaard Rasmussen, Robert Gvozdenovic

Effectiveness and implementation of mPATH™-CRC: a mobile health system for colorectal cancer screening

Anna C. Snavely, Kristie Foley, Ajay Dharod, Mark Dignan, Holly Brower, Elena Wright, David P. Miller Jr.

  • Open Access
  • Care
  • Research

A comparative study of the effects of Kangaroo care by mothers and maternal grandmothers on the vital signs of hospitalized preterm newborns: a randomized controlled clinical trial study

Zahra Dargahiyan, Fatemeh Ghasemi, Kimia Karami, Fatemeh Valizadeh, Rasool Mohammadi

EffEx-HN trial: study protocol for a randomized controlled trial on the EFFectiveness and feasibility of a comprehensive supervised EXercise program during radiotherapy in Head and Neck cancer patients on health-related quality of life

Kaat Van Aperen, An De Groef, Nele Devoogdt, Tessa De Vrieze, Thierry Troosters, Heleen Bollen, Sandra Nuyts

EXCHANGE-2: investigating the efficacy of add-on plasma exchange as an adjunctive strategy against septic shock—a study protocol for a randomized, prospective, multicenter, open-label, controlled, parallel-group trial

Sascha David, Christian Bode, Klaus Stahl, Julius Schmidt, Benjamin Seeliger, Thorben Pape, Bernhard Schmidt, Marius M. Hoeper, Heiner Wedemeyer, Tobias Welte, Kai Schmidt-Ott, Pedro David Wendel Garcia, Daniel A. Hofmänner, Rea Andermatt, Reto Schuepbach, Andriyana Bankova, Hans-Joerg Gillmann, Thomas Stueber, Carolin Jung, Andre Gerdes, Christian Putensen, Andrea Sauer, Lennart Wild, Felix Lehmann, Markus A. Weigand, Christian Nusshag, Judith Schenz, Sebastian O. Decker, Mascha O. Fiedler, Florian Uhle, Michael Bauer, Julia Leonhardt, Frank Bloos, Silke Rummler, Philipp Enghard, Abakar Magomedov, Daniel Zickler, Julius Kunz, Jochen Dutzmann, Alexander Vogt, Matthias Girndt, Silke Markau, Mathias Kochanek, Jan-Hendrik Naendrup, Alexander Zarbock, Melanie Meersch, Thilo von Groote, Mahan Sadjadi, Carola Wempe, Steffen Mitzner, Markus Heim, Stefanie Pilge, Nicolas Bubendorfer, Gerhard Schneider, Tobias Lahmer, Sebastian Rasch, Thorsten Brenner, Marc M. Berger, Jens Brands, Florian Espeter, Julius Freytag, Stefan Kluge, Dominik Jarczak, Axel Nierhaus, Jan T. Kielstein, M. Winkler, Thomas Fühner, Jan Schmieszek, Jan Menne, Martin Sauer, Georg Richter, Ingmar Lautenschläger, David Radke, Ansgar Reising, Alexander Keil, Joern Bramstedt, Mustafa Fahham, Carsten Willam, Larissa Herbst, Karl Bihlmaier, Christoph Buettner, Peter Schellongowski, Elisabeth Lobmeyr-Längle, Gürgkan Sengölge, Thomas Staudinger, Joerg C. Schefold, Philipp Venetz, Jan Waskowski, Carmen A. Pfortmueller, Michael Joannidis, Gert Mayer, Romuald Bellmann, Armin Koch, Xiaofei Liu

  • Open Access
  • Study protocol

VR-SOAP, a modular virtual reality treatment for improving social activities and participation of young people with psychosis: a study protocol for a single-blind multi-centre randomized controlled trial

Ivo Alexander Meins, Dauw Catharina Muijsson-Bouwman, Saskia Anne Nijman, Kirstin Greaves-Lord, Wim Veling, Gerdina Hendrika Maria Pijnenborg, Elisabeth Christine Dorothée van der Stouwe

A cluster randomised trial to evaluate the effectiveness of household alcohol-based hand rub for the prevention of sepsis, diarrhoea, and pneumonia in Ugandan infants (the BabyGel trial): a study protocol

Martin Chebet, David Mukunya, Kathy Burgoine, Melf-Jakob Kühl, Duolao Wang, Antonieta Medina-Lara, Eric Brian Faragher, Amos Odiit, Peter Olupot-Olupot, Ingunn Marie Stadskleiv Engebretsen, John Baptist Waniaye, Julius Wandabwa, Thorkild Tylleskär, Andrew Weeks

Postoperative awake prone position in geriatric patients with hip fractures: a protocol for a randomized controlled trial on the efficacy of postoperative prone position in reducing pulmonary complications and improving oxygenation

Yu-cheng Gao, Liu Shi, Yuan-wei Zhang, Wang Gao, Xie Tian, Mu-min Cao, Ying-juan Li, Hui Chen, Yun-feng Rui

Safety and effectiveness of standardized exercise training in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (TRAIN-HFpEF-PH): study protocol for a randomized controlled multicenter trial

Eglė Palevičiūtė, Jelena Čelutkienė, Toma Šimbelytė, Lina Gumbienė, Elena Jurevičienė, Diana Zakarkaitė, Sigitas Čėsna, Christina A. Eichstaedt, Nicola Benjamin, Ekkehard Grünig

  • Open Access
  • Gout
  • Study protocol

Urate-lowering therapy following a treat-to-target continuation strategy compared to a treat-to-avoid-symptoms discontinuation strategy in gout patients in remission (GO TEST Finale): study protocol of a multicentre pragmatic randomized superiority trial

Iris Rose Peeters, Alfons A. den Broeder, William J Taylor, Nathan den Broeder, Marcel Flendrie, Noortje van Herwaarden

  • Open Access
  • Obesity
  • Study protocol

Effectiveness and safety of Daixie Decoction granules combined with metformin for the treatment of T2DM patients with obesity: study protocol for a randomized, double-blinded, placebo-controlled, multicentre clinical trial

Zhidong Liu, Kepei Zhang, Jianpin Zhang, Fei Wang, Yang Zhou, Lin Wang, Miao Wang, Yi Zhang, Shigao Zhou

Glucagon-like peptide-1 analogues: a new way to quit smoking? (SKIP)—a structured summary of a study protocol for a randomized controlled study

Sophia Lengsfeld, Thilo Burkard, Andrea Meienberg, Nica Jeanloz, David Coynel, Deborah R. Vogt, Lars G. Hemkens, Benjamin Speich, Davide Zanchi, Tobias E. Erlanger, Mirjam Christ-Crain, Bettina Winzeler

  • Open Access
  • Care
  • Study protocol

Effect of a customized digital adherence tool on retention in care and adherence to antiretroviral treatment in breastfeeding women, children and adolescents living with HIV in Tanzania: a mixed-methods study followed by clinical trials

I. Marion Sumari-de Boer, Kennedy M. Ngowi, Iraseni U. Swai, Lyidia V. Masika, Rehema A. Maro, Alan E. Mtenga, Benson A. Mtesha, Pythia T. Nieuwkerk, Ria Reis, Tobias F. Rinke de Wit, Rob E. Aarnoutse

  • Open Access
  • Study protocol

Statistical analyses of ordinal outcomes in randomised controlled trials: protocol for a scoping review

Chris J. Selman, Katherine J. Lee, Clare L. Whitehead, Brett J. Manley, Robert K. Mahar

TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, double-blinded, randomized, 3-arm trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older women

Alison J. Huang, Louise C. Walter, Kristine Yaffe, Eric Vittinghoff, Erica Kornblith, Michael Schembri, Ann Chang, Leslee L. Subak

  • Open Access
  • Care
  • Research

Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis

Douglas Zatzick, Lawrence Palinkas, David A. Chambers, Lauren Whiteside, Kathleen Moloney, Allison Engstrom, Laura Prater, Joan Russo, Jin Wang, Khadija Abu, Matt Iles-Shih, Eileen Bulger

  • Open Access
  • Methodology

DMC reports in the 21st century: towards better tools for decision-making

Marc Vandemeulebroecke, Mark Baillie, Ardalan Mirshani, Emmanuel Lesaffre

  • Open Access
  • Study protocol

Smell and taste of milk during tube feeding of preterm infants: neurodevelopmental follow-up of the randomized TASTE trial, study protocol

Friederike Beker, Ian P. Hughes, Sue Jacobs, Helen G. Liley, Samudragupta Bora, Gabrielle Simcock, Peter G. Davis

  • Open Access
  • Study protocol

A study protocol for the randomized controlled trial SAFIR FAMILY TALK: a selective primary preventive intervention vs. service as usual for children of parents with mental illness

Signe S. Nielsen, Lisbeth J. Mikkelsen, Nikolaj Quaade, Tracy R. G. Gladstone, William R. Beardslee, Katrina Bonnemose, Nicole K. Rosenberg, Carsten Hjorthøj, Anne A. E. Thorup, Merete Nordentoft, Anne Ranning

Evaluating the equity impact and cost-effectiveness of digital adherence technologies with differentiated care to support tuberculosis treatment adherence in Ethiopia: protocol and analysis plan for the health economics component of a cluster randomised trial

Nicola Foster, Amare W. Tadesse, Christopher Finn McQuaid, Lara Gosce, Tofik Abdurhman, Demelash Assefa, Ahmed Bedru, Rein M. G. J. Houben, Kristian van Kalmthout, Taye Letta, Zemedu Mohammed, Job van Rest, Demekech G. Umeta, Gedion T. Weldemichael, Hiwot Yazew, Degu Jerene, Matthew Quaife, Katherine L. Fielding

The rationale and study design of two phase II trials examining the effects of BI 685509, a soluble guanylyl cyclase activator, on clinically significant portal hypertension in patients with compensated cirrhosis

Thomas Reiberger, Annalisa Berzigotti, Jonel Trebicka, Judith Ertle, Isabella Gashaw, Ros Swallow, Andrea Tomisser

  • Open Access
  • Commentary

Surgical trial design for incorporating the effects of learning: what is the current methodological guidance, and is it sufficient?

Neil Corrigan, Julia M. Brown, Richard Emsley, David G. Jayne, Rebecca E. A. Walwyn

Does an app designed to reduce repetitive negative thinking decrease depression and anxiety in young people? (RETHINK): a randomized controlled prevention trial

Julia Funk, Johannes Kopf-Beck, Edward Watkins, Thomas Ehring

  • Open Access
  • Research

Developing strategies to address disparities in retention communication during the consent discussion: development of a behavioural intervention

Taylor Coffey, Eilidh Duncan, Heather Morgan, Katie Gillies

  • Open Access
  • Research

Exploring implementation outcomes in the clinical trial context: a qualitative study of physician trial stakeholders

Kristian D. Stensland, Anne E. Sales, Varsha K. Vedapudi, Laura J. Damschroder, Ted A. Skolarus

ESTIMation of the ABiLity of prophylactic central compartment neck dissection to modify outcomes in low-risk differentiated thyroid cancer: a prospective randomized trial

Dana Hartl, Yann Godbert, Xavier Carrat, Stéphane Bardet, Audrey Lasne-Cardon, Pierre Vera, Elena Ilies, Slimane Zerdoud, Jérôme Sarini, Mohamad Zalzali, Luigi La Manna, Olivier Schneegans, Antony Kelly, Philppe Kauffmann, Patrice Rodien, Laurent Brunaud, Solange Grunenwald, Elie Housseau, Salim Laghouati, Nathalie Bouvet, Elodie Lecerf, Julien Hadoux, Livia Lamartina, Martin Schlumberger, Isabelle Borget

  • Open Access
  • Methodology

Using re-randomisation designs to increase the efficiency and applicability of retention studies within trials: a case study

Beatriz Goulao, Anne Duncan, Karen Innes, Craig R. Ramsay, Brennan C. Kahan

G-FORCE: the effectiveness of group psychotherapy for Cluster-C personality disorders: protocol of a pragmatic RCT comparing psychodynamic and two forms of schema group therapy

Birre B. van den Heuvel, Jack J. M. Dekker, M. Daniëls, Henricus L. Van, Jaap Peen, Judith Bosmans, Arnoud Arntz, Marcus J. H. Huibers

Effects of a peripherally acting µ-opioid receptor antagonist for the prevention of recurrent acute pancreatitis: study protocol for an investigator-initiated, randomized, placebo-controlled, double-blind clinical trial (PAMORA-RAP trial)

Mathias E. Cook, Cecilie S. Knoph, Camilla A. Fjelsted, Jens B. Frøkjær, Anders E. Bilgrau, Srdan Novovic, Maiken Thyregod Jørgensen, Michael B. Mortensen, Liv B. J. Nielsen, Amer Hadi, Mark Berner-Hansen, Wiktor Rutkowski, Miroslav Vujasinovic, Matthias Löhr, Asbjørn M. Drewes, Søren S. Olesen

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Evaluation of the efficacy of HEMO2life®, a marine OXYgen carrier for Organ Preservation (OxyOp2) in renal transplantation: study protocol for a multicenter randomized trial

Yannick Le Meur, Emmanuel Nowak, Benoit Barrou, Antoine Thierry, Lionel Badet, Matthias Buchler, Jean-Philippe Rerolle, Leonard Golbin, Agnès Duveau, Jacques Dantal, Pierre Merville, Nassim Kamar, Leïla Demini, Franck Zal

Drainless robot-assisted minimally invasive oesophagectomy—randomized controlled trial (RESPECT)

B. Müssle, J. Kirchberg, N. Buck, O. Radulova-Mauersberger, D. Stange, T. Richter, B. Müller-Stich, R. Klotz, J. Larmann, S. Korn, A. Klimova, X. Grählert, E. Trips, J. Weitz, T. Welsch

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Surgical treatments for postamputation pain: study protocol for an international, double-blind, randomised controlled trial

Emily Pettersen, Paolo Sassu, Carina Reinholdt, Peter Dahm, Ola Rolfson, Anders Björkman, Marco Innocenti, Francesca Alice Pedrini, Juan Manuel Breyer, Aidan Roche, Andrew Hart, Lorraine Harrington, Adil Ladak, Hollie Power, Jacqueline Hebert, Max Ortiz-Catalan

  • Open Access
  • Methodology

Informed consent in randomised controlled trials: further development and evaluation of the participatory and informed consent (PIC) measure

Julia Wade, Elka Humphrys, Alba X Realpe, Daisy M Gaunt, Jenni Burt, James P. Sheppard, Mark Lown, Eleanor Temple, Rebecca Lowe, Rosalyn Fraser, Julie Allen, Gary A Ford, Carl Heneghan, F. D. Richard Hobbs, Sue Jowett, Shahela Kodabuckus, Paul Little, Jonathan Mant, Jill Mollison, Rupert A. Payne, Marney Williams, Ly-Mee Yu, Richard J. McManus, Carmel Conefrey, Jenny Donovan, Nicola Farrar, Marcus Jepson, Ava Lorenc, Nicola Mills, Sangeetha Paramasivan, Leila Rooshena

Efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSC PLEB001) for the treatment of grade II–IV steroid-refractory acute graft-versus-host disease: a study protocol for a multicenter, randomized, double-blind, placebo-controlled, phase II trial

Donglin Yang, Xiaoqiang Hou, Kun Qian, Yuhang Li, Liangding Hu, Liang Li, Mingzhe Han, Chen Yao, Daihong Liu

Stereotactic Body radiotherapy and pedicLE screw fixatioN During one hospital visit for patients with symptomatic unstable spinal metastases: a randomized trial (BLEND RCT) using the Trials within Cohorts (TwiCs) design

E. H. Huele, J. M. van der Velden, N. Kasperts, W. S. C. Eppinga, J. P. C. Grutters, B. B. M. Suelmann, A. A. Weening, D. Delawi, S. C. C. M. Teunissen, H. M. Verkooijen, J. J. Verlaan, R. Gal

A Study of Individualized Diagnosis and Treatment for Depression with Atypical Features (iDoT-AFD): study protocol for a randomized clinical trial and prognosis study

Rubai Zhou, Huifeng Zhang, Shen He, Yi Li, Guiyun Xu, Jinsong Huang, Huaning Wang, Qian Wang, Biao Li, Xuemei Wang, Ningning Chen, Fang Li, Xiaosa Li, Mengjun Liu, Daihui Peng

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Correction: Effect of focused power ultrasound-mediated perirenal fat modification on primary hypertension: protocol of a multicenter, randomized, double-blinded, sham-controlled study

Menghuan Li, Jing Shi, Yanhui Sheng, Yuqing Zhang, Tingting Wu, Jiaming Yang, Kerui Zhang, Wei Sun, Xiangqing Kong

Protocol for an evaluation of adherence monitoring and support interventions among people initiating antiretroviral therapy in Cape Town, South Africa—a multiphase optimization strategy (MOST) approach using a fractional factorial design

Lauren Jennings, Rebecca L. West, Nafisa Halim, Jeanette L. Kaiser, Marya Gwadz, William B. MacLeod, Allen L. Gifford, Jessica E. Haberer, Catherine Orrell, Lora L. Sabin

The effect on incisional hernia of absorbable barbed suture for midline fascial closure in minimally invasive surgery for colorectal and gastric cancers: study protocol for a randomized controlled trial

Sejin Lee, Se Wung Han, Min Ro Lee, Chan-Young Kim, Gi Won Ha

The influence of shunting left/right portal vein branch on post-TIPS hepatic encephalopathy: a study protocol for multicenter randomized blinded controlled trial

Jingqin Ma, Jianjun Luo, Wen Zhang, Yongjie Zhou, Zihan Zhang, Minjie Yang, Zhiquan Zhuang, Li Ma, Jiaze Yu, Xin Zhou, Zhiping Yan

Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial: study protocol for a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery

Mark R. Edwards, Gordon Forbes, Neil Walker, Dion G. Morton, Monty G. Mythen, Dave Murray, Iain Anderson, Borislava Mihaylova, Ann Thomson, Matt Taylor, Marianne Hollyman, Rachel Phillips, Keith Young, Brennan C. Kahan, Rupert M. Pearse, Michael P. W. Grocott, Alexandra Skubala, Patrick Tapley, Suzanne Kellett, Clare Bolger, Rachel Burnish, Nikki Collings, Andrew Cumpstey, Hannah Wong, Vic Rehnberg, Jessica Lees, Karen Salmon, Naomi Wee, Sarah Harrison, Li Ping Gan, Claire Halloran, Georgios Tsiopanis, Said Seifalian, Richard Webster, Martin Knight, Hannah Theobald, Anna Clark, Thomas Nicholls, James Willey, Sophia Beeby, Luke Bracegirdle, Kate Stoddard, Belinda Roberts, Alice Baker, Norma Diaper, Jonathan Biss, Michael Carter, Francesca Riccio, James Green, Lucy Johnstone, Jade Rand, Kasia Wisniewska, Grant Gibson, Hannah Bateson, Michelle Beveridge, Martyna Marani, Isabel Monger, Agnieszka Burtt, Gary Minto, Iain Christie, Anna Fergusson, Abigail Patrick, Stuart Cleland, Charlotte Eglinton, Natasha Wilmshurst, Fiona Reed, Joanne Smith, Anna Ratcliffe, Elizabeth Freeman, Jennie Kingdon, James Humphreys, Sarah Nelson, Adrian Jennings, Angela Watts, Andrew Moores, Lucy Smith, Jenny Wright, Julian Sonksen, Caroline Moody, Philip Harrington, Jack Lee, Nadim Kozman, Zoe Riddell, Catherine Brennan, Shakira Nathoo, Vikram Anumakonda, Andrea Gait, Richard Pierson, Raj Patel, Lee Plant, Nipun Agarwal, Hadassah Ihlenfeldt, James Heggie, Rachel Olive, Joseph Pick, Sally Hinsley, Nicola Calthorpe, Julie Matthews, Wendy Gardner, Charlotte Topham, Edward Jones, Elliot Yates, Sachin Sekhsaria, Mohamed Amer, Phil Pemberton, Nicholas Coffin, Halden Hutchinson-Bazely, Karen June Pearson, Tracy Edwards, Beth Fitzmaurice, Anna Pierson, Katie Archer, Omar Ahmed, Sajid Khan Mohammed, Alex Hollis, Stephanie Weedon, David Hillier, Joanna Lau, Vishal Amin, Laura Dixon, Joseph Seager, Joe Tyler, Stacey Forsey, N. Parry, Aamer Mughal, Jialuen Goh, Rose Tiller, Daniel Taylor, Hasini Rallage, Alexandra Leech, John Harris, Claire Gabriel, Sheron Clarke, Katherine Pagett, Thomas Rudnick, Nick Brown, Sarah Hare, Eimhear Lusby, Edward Bayliss, Christopher Ward, Rahul Bandopadhyay, Kerrie Wilson, Theodore Floyd, Iram Ahmed, Tom Hatton, Malgorzata Szeszo, Thyra Kyere-Diabour, Daniel Sumner, Tessa Lawrence, Emma Sutton, Winston Ng, Ioannis Kapsokalyuas, Anthony Carter, Anamika Kansal, Leon Bernard, Siew-Ling Harrison, Andrew Feneley, Owen Cooke, Jennifer Hawley, Sophie Berry, Laura Adams, Thomas Hansen, Pieter Bothma, Julie North, Teresa Ferreira, Karan Verma, Karthik Surendran, Aruthy Arumugam, Sunil Jamadarkhana, Carina Cruz, Pearl Baker, Naomi Brice, Antony Ashton, McDonald Mupudzi, Juliette Kemp, Ajay Rahl, Denise Griffin, Aaron Stokes, Keith Ritchie, Arcot Venkatasubramaniam, Robert Cheek, Madonna Brown, Dawn Trodd, Caroline Wrey Brown, Jane Martin, Sam Hammond, Louisa Mason, Nycola Muchenje, Hamish Breach, Amanda Colston, Malcolm Watters, Edwards Miles, Emma Marshall, Madeleine Storey, Victoria Hawley, Edward Gomm, Claire Potter, Melanie Knowles, Edward Beech, Peter van Breda, Helen Langton, Nicholas Suarez, Matthew Rowe, Andrei Tanase, Jonathan Barnes, David Earl, Lorraine Stephenson, Tracy Burdett, Martin Huntley, Emma Cottrell, Hao Ern Tan, Joyce Yeung, Jasraj Kailey, Teresa Melody, Jo Gresty, Julia Sampson, Katie Atterbury, Peter Sutton, Natalie Carling, Eleanor Reeves, Carl Groves, Daniel Crossmann, Sarah Ballinger, Rachel Smith, Marie Thomas, Will Rook, Mohamed Mooradun, Qasim Khan, Arif Qureshi, Llewellyn Fenton-May, Adam Boulton, Daniel Whitney, Shilpa Sannakki, Manekar Avinash, Nikiesha Lee, Neha Sharma, Srinivas Magham, Gareth Moncaster, Rebecca Boulton, Terri-Ann Sewell, Wayne Lovegrove, John Tansley, Nick Watson, Sarah Shelton, Cheryl Heeley, Philip Buckley, Katie Slack, Rebecca Holmes, Andrea Palfreman, Christopher Smith, Mandy Gill, Sue Smith, Tracy Brear, Jill Kirk, Megan Holmes, Camelia Goodwin, Margaret Flynn, Inez Wynter, Kaytie Bennett, Stephen Harris, Corrine Pawley, Patricia Doble, Moira Tait, Richard Gibbs, Tom Edwards, Paul Mackey, Miss Louise Hunt, Jo Hutter, Ed Smyth, Hamish Noble, Thomas Judd, Rose Arkell, Owen Thomas, Karen Watura, Marius Vaida, Suehana Rahman, Saaidullah Sufi, Helder Filipe, Christine Eastgate, Margaret McNeil, Stephen Howey, Glykeria Pakou, Sara Mingo, Amitaa Maharajh, Irina Grecu, Samantha Hammond, Susan Hanson, Julia Ottaway, Victoria Burgess, James Fry, Geoff Watson, Francois Wessels, Hugh Cutler, Arthur Goldsmith, Mark Howes, Subash Sivasubramaniam, Julie Colley, Jenny Porter, K. P. Krishnan, Kerrie Aldridge, Sylvia Willetts, Carol Zullo, Christopher Thompson, Pradeep Shanmugasundaram, Judith Abrams, Katarina Manso, Jamil Razzaque, Sally Scott, Geraldine Hambrook, Elizabeth McKerrow, Tahir Ali, Alastair Ankers, Mohan Ranganathan, Sunil Bellam, Sophie Mason, Paul Marriott, Richard Robley, Bridget Campbell, Penny Parsons, Sean Ramcharan, Susanne Mohamed Anver, Valerie Page, Elaine Walker, Xiaobei Zhao, Laura Osborne, Beena Parker, Rupinder Kaur, Gitana Kulakauskaite-Rasteniene, Mehul Patel, Alastair Lowe, Emma Edmunds, Kieran Hills, Michail Klimovskij, Christopher Ranns, Radha Ganesh, David Jones, Jamie Gibson, Janet Sinclair, Karen Burton, Toni De Freitas, Leon Dryden, Amelia Robinson, Nnamdi Udezue, Tim Faccini, Moon-Moon Majumdar, Kelly Death, Hide Baba, Jaydraman Narendran, Bret Claxton, Andrew Brennan, Louise Akeroyd, Sarah Cooper, Catherine Farrow, Carl Ilyas, James Morgan, Craig Montgomery, Brian Wilkinson, John Dereix, Karen Eaves-Lai, Kate Pye, David Craske, Paul Panesar, Peter Hart, Mark Stubbington, Kim Storton, Kelvin Stewart, Laura Graham, Shereen Bano, Robert Neal, Declan Ryan-Wakeling, Varun Chauhan, Michael Shaw, Maame Aduse-Poku, Soo Jin Kang, Gill Arbane, Kariem El-Boghdadly, Paul Kelly, Jaimin Patel, Marcin Sicinski, Martin John, Mark Ibrahim, Emad Aziz, Sohini Sengupta, Melissa Baldwin, Toby Dixson, Leslie D’souza, Charlotte Taylor, Suneil Rameseur, Heena Bidd, Guy Glover, Andrew Morley, Asta Lukosiute, Anna Janowicz, Tamara Alexander, Joe Lipton, Rathai Anandanadan, Dale Seddon, Alexander Phillips, Louise Davies, Sanjoy Bhattacharyya, Soo Yoon, Sian Fraser, Alex Stilwell, Karin Shoeman, Justin Hews, Sivanth Sivakumar, Floju Chin, Declan Dudley, Gary Colville, Abegail Sawana, Jakob Dudziak, Britta O’Carroll-Kuehn, Chandran Jeganathan, Nicole Richards, Andrew Swain, Charlotte Quamina, Indu Sivanandan, Simon Whiteley, Elizabeth Wilby, Charlotte Quamina, Charlotte Trumper, Kate Varley, Sharmeen Lotia, Eugene Henry, Claire Schofield, Ntima Ntima, Omar Jundi, Amelia Schorah, Luke McMenamin, Robert Jackson, John Jones, Suzie Colquhoun, Joana Faria, Nora Youngs, Aneesha Qadeer, Judith Sharp, Rosie Wragg, Michelle Naylor, Beverley Jackson, Catherine Moriarty, Louise White, Laura Wade, Brian White, Samuel Craven, Coralie Carle, Alan Pope, Mark Chen, Nicola Butterworth-Cowin, Rajneesh Sachdeva, Karen Ellis, Colin Bergin, Emma Reeves, Amy Bamford, Maximina Ventura, Tony Whitehouse, Ronald Carrera, Elaine Spruce, Liesl Despy, Samantha Harkett, Morgan Foster, Antonios Athanasiou, Kamran Malik, Stephanie Porter, Randeep Mullhi, Craig Sadler, James Gasbey, Christopher McGhee, Jignesh Patel, Tracy Mason, Hazel Smith, Alexandra Efimov, Aoife Neal, Stephanie Goundry, Davina Ross-Anderson, Kath MacGloin, James Pennington, Tim Martin, Edyta Niebrzegowska, Mevan Gooneratne, Chhaya Sharma, Neil MacDonald, Jan Whalley, Priyanthi Dias, Gareth Ackland, Peter Shirley, Tim Stephens, Parjam Zolfaghari, Steven Dunkley, Toby Reynolds, Henry Walton, Matthew Smith, Shreya Bali, Sara Hui, Ravi Bhatia, Hew Torrance, Maria Fernandez, Ruzena Uddin, Filipa Santos, Amaia Arrieta, Stephen Barrett, Richard Cashmore, Eleanor Richards, Fatima Seidu, Edward McIlroy, Thomas Urwin, John Samuel, Katherine Brooks, Natalie Gravell, Douglas Blackwood, Tanj Sanghera, Mareena Joseph, Aisha Jalaly, Hannah Nugent, Ben Goodman, Ashley Scott, Ian Clement, Leigh Dunn, Abigail Harrison, Carole Hays, Maite Babio-Galan, Sarah Todd, Lindsay Dawson, Stephanie Henderson, Kapil Arora, Subramani Diwaker, Sam Marcangelo, James Harvey, Mark Dalton, Jeremy Hyams, Tara Shrestha, Kimberley Zwiggelaar, Laura Heggie, Rhona Sinclair, Ben Brown, Sean Cope, Steven Traill, James Durrand, Julie Sheriff, Ashley Allan, Lindsey Woods, Erin Chuter, Rebecca Betts, Rossalyn Thistlethwaite, Elizabeth Turnbull, Monojit Paul, Pete Campbell, Vlad Bashlijski, Charlotte Foley, Amy Ginn, Adam Cookson, Sarah Cornell, Janaki Pearson, Kimberley Rogerson, Ben Eden-Green, Marthin Mostert, Maria Leong, Daniel James Kirkin, Rosie Reece-Anthony, Fatima Ali, Michaela Heller, George Mathew, Beenu Madhavan, Katherine Powell, Noelene Dasey, Waqas Khaliq, Babita Gurung, Cristina Alkhadra, Tarek Mostafa, James Winchester, Megan Thomas, Amit Soodan, Alfa Cresia Nilo, Matthew Bridge, Colette Jones-Criddle, Laura Wilding, Ian Turner-Bone, Ben Morton, Tim Gilbert, Nathan Littley, Natasha Clarke, Greg Moore, Tamryn Miller, Tom Rudnick, Tom Miller, Manab Haldar, Ashok Nair, Michael Jarvis, Precious Basvi, Gillian Bell, Michelle Edwards, Clare Mewies, Stelios Vakis, Emily Burton, Kiran Yelamati, Amit Das, Abhimanyu Bhattacharya, Daniel Massey, Ramkumar Kalaiyarasan, Amro Katary, Win Maung, Dave Robinson, Beth Frost, Samuel Besant, Sunita Gurung, Agah Isguzar, Mina Amirhom, Muhammad Javid, Ashok Raj, Gabrielle Adkins, Rahim Nadeem Ahmed, Josphine Cashman, Elizabeth Smee, Clare Ivermee, Charlotte Cobain, Ana Robles, Yin Choo, Reena Khade, Narayanan Suresh, Lynne Williams, Michele Clark, Pam Race, Anil Agarwal, Rakesh Bhandary, Valasubramaniam Mahadevan, Michael Courtney, James Walker, Susan Hayward, Luke Vamplew, Sally Pitts, Debbie Branney, Andrew Bates, Katie Molloy, Nina Barratt, Sarah Turle, Doug Tunney, Erica Jolly, Tallulah Webb, Katie Bowman, Jessica Kelly, Rebecca Miln, Juan Graterol, Fiona Hammonds, Jessica Summers, Belinda Wroath, Gabbie Young, Benita Adams, Nicki Devooght-Johnson, Eve Fletcher, Michele Wall, Kelly O’Toole, Allwyn Cota, Richard Hunt, Toby Nisbett, Sam Spinney, Tanuja Shah, Brett Doleman, Laura Carrick, Nagendra Prasad, Kathleen Holding, Lianne Hufton, William Speake, Philip Herod, James Nayyar, Daniel Stolady, Shuing Wei, David Daly, Corinne Paxton, Tauseef Ahmed, Anwar ul Huda, Christopher Goddard, Paul Ainsworth, Thomas James Murphy, Barry Jones, Anna Morris, Helen Terrett, John Kirby, Ann Holden, Mark Spiliopoulos, James Hammond, Iain Cummings, Helen Melsom, Louise Duncan, Sameer Somanath, Andrea Kay, Melanie Kent, Michelle Wood, Sarah Clark, Liam O’Hare, Lewis Schofield, Ami Laidlaw, Jordan Minns, James Roe, Stefanie Hobson, Suzanne Naylor, Vicki Atkinson, Phoebe Syme, Lisa Grimmer, Kate Driver, Libby Cole, Denise Webster, John Hickman, Carly Webb, Katie Sweet, Edward Mew, Sarah Warwicker, Susan Tetlow, Alex Middleton, Jonathan Rees, Chris Gough, Sam Howell, Chloe Searles, Shelley Barnes, Louise Seller, Jim Dunham, Alastair Brown, Zoe Garland, Adam Duffen, Thomas Renninson, Anna Chillingworth, Paul Watson, Alex Jones, Rebekah Johnson, Krisztina Kenesey, Thomas Cope, Samuel Fitzpatrick, Annie Amphlett, Christopher Sajoler, James Matthams, Natalie Constable, Jo Poole, Hannah Wilson, Liz Hood, Ruth Greer, James Self, Katherine Nickell, William Headdon, Charlotte Earnshaw, Katie Samuel, Richard Pugh, Jill Andrews, Sarah Evans, Zain Habib, Claudia Variu, Mohammed Zardab, Amy Ellison, Victoria Garvey, Richard Morgan, Shobna Ramakrishnan, Shrisha Shenoy, Michael Kriger, Hefin Llewellyn, Sophie Horrocks, Sam McBride, Rachel Mawley, Alexander Pereiradelima, Tim Cook, Emira Kursumovic, Sarah Hierons, Lucy Howie, Stuart Younie, Lidia Ramos, Tom Cloke, Sara-Catrin Cook, Ben Savage, Alex Dunn, Mark Sheils, Sarah Mitchard, Matthew Gibbins, Olivia Cheetham, Neil Choudhuri, Amelia Davies, Peter Steed, Abigail Harper, Dipayan Choudhuri, Ben Ballisat, Carrie Demetriou, Tim Cominos, Rebecca Powell, Gabrielle Evans, Johannes Retief, Thomas Clark, Jane Montgomery, Rachel Remnant, Ciska Uys, Gabrielle de Selincourt, Sally Ward-Booth, Simon George, Omar Islam, Adam Revill, Daniel Paul, David Portch, Pauline Mercer, Elaine Vandecandelaere, Lorraine Thornton, Victoria Field, Ken Almedilla, Natalie Smith, Jennifer Moran, Thomas Hunt, James Womersley, Raine Thornton, Anne McCarthy, Fleur Rogers, Julie Merizouris, Will Hare, Jonathan Carter, Katie Flower, Greg Warren, Ben Whatley, Virginia Francis, Julie Wollaston, Alex Redome, Louise Cossey, William Spencer, Mike McGovern, Vicky Lewis, Matthew Boyd, Christopher Newell, Sethina Watson, Beverley Faulkner, Emma Gendall, Kati Hayes, Ruth Worner, Elizabeth Goff, Tim Howes, David Cronin, Jacques Carver, Daragh Lehane, Kath Jenkins, Matthew Townsend, Helen Williams, Gemma Nickols, Jodie Garrett, Alexander Jones, Benjamin Savage, Swati Gupta, Mark Dorrance, Edward Lent, Kerry Smith, Dragos Dragnea, Rebecca Williams, Emma Jenkins, Richard Mason, Lydia Osborne, Matt Thomas, Agnieszka Kubisz-Pudelko, Mohamed Gheith, Joanna Allison, Alison Lewis, Kate Beesley, Lucy Pippard, Andrew Shrimpton, Tressy Pitt-Kerby, Jeremy Reid, Nigel Beer, Jess Perry, Matthew Garner, Harriet Noble, Sian Saha, Eleanor Corcoran, John Smith, Evita Pappa, Louise Greig, James Bland, Gudrun Kunst, Elena Stanton, Emma Clarey, Joe Macmillan, Tamsin Rope, John Shenouda, Thomas O’Dell, Hannah Matthews, Temi Adedoyin, Nicola Schunke, Rebecca Mersh, Rosie May, Ashraf Mohammed, Cara Lewis, Eoin Harty, Jonny R. Stephens, Abigail Richardson, Roger Sharpe, Chima Oti, Palitha Bopitiya, James Read, Kiran Chima, Maria Henriksson, Alexa Prichard, Fei Long, John Brandreth, Puvan Suppiah, Winnie Anunda, Kathryn Singh, Claire Ruck, Eleanor Roderick, Isabelle Kamenou, Najwa Soussi, Putul Sarkar, Stefan Wiebe, Yadullah Syed, Aishi Lim, Kerry Barnes, Kwabena Mensah, Aidan Fullbrook, Larry Mulleague, Matt Varier, Viplaw Shukla, Ravi Srinivasan, Najam Pervez, Natasha Schneider, Jasmin Shahnavaz, Duncan Bailey, Rosavic Chicano, Neringa Vilimiene, Shahzaib Ahmad, Neil Richardson, Youssef Mahmoud, Shanni McDonald, Natasha Schumacher, Svetlana Velinova-Teron, Rohit Silhi, Guy Chivers, Julie-Ann Davies, Tracey Cosier, Barry Featherstone, James Rand, Esther Cook, Diana Neely, John Coombes, Harpreet Sodhi, Thomas Burr, Mark Oliver, Michelle Walters, Kim Jemmett, Claudia Dulea, Lucy Cooper, Sam Mcferran, Maxime Rigaudy, Kim Jennett, Heather Weston, Reanne Solly, Emma Ignall, Cathy Praman, Vincent Hamlyn, Gayathri Chinnappa-Srinivas, Angie Organ, Tudor Vlad Moisin, Julia Parnell, Matthew Whitehead, Olivia Hayward, Rosie Malkin, Zoe Bennetton, Anne Devine, Tim Green, Joanna Hubert, Sam Andrews, Deborah Ward, Pauline Brown, Nick Vallotton, Jon Glass, Susan O’Connell, Alice Bevan, Tom Brougham, Lawrie Kidd, Sian Hughes, Jeannine Stone, Deborah Mann, Helen Murray, Fiona Davis, Mark Eveleigh, Jake Hartford-Beynon, Katherine Stratton, Kat Yan Yee Ng, Mandeep Phull, George Joseph, Kalyani Gorrela, Viraj Weerasekera, Nazneen Sudhan, Ayub Khan, Louis Chalmers, Ben Huntley, Sandra Chipperfield, Aparna George, Lace Paulyn Rosario, Tatiana Pogreban, Robert Buhain, Alia Hussain, Asya Veluso Costa, Eleanor Richards, Charles Gibson, Sandeep Kusre, Melanie Hutchings, Sinéad Kelly, Rebecca Pugsley, Hamza Malik, Alec Beaney, Tom Woodward, Zahra Essackjee, Kangni Chen, Bruce McCormick, Cath Matthews, Michelle Walter, Elizabeth Gordon, Sadie Heddon, Timothy Warrener, Peter Valentine, Joel Prescott, Samantha Keenan, Emily Johnson, Eleanor Higgs, Jessica Thrush, Laura Tulloch, Fiona Osborne, Victoria Poyntz, Pooja Takhar, Connie Rowlands, Michael Mcalindon, Victoria Lacey, Nicholas Cowley, Stephanie Chamberlain, Sally Rudge, Sian Bhardwaj, David Freeman, Brendan Spooner, Satinder Dalay, Nick Fitton, Rebecca Davies, Kay Fisher, Laura Naumann, Elma Wong, Simon Leach, Helen Moore, Rebecca Wilcox, Rhys Parry, Alison Magness, Mandy Carnahan, Matthew Travis, Colene Adams, Samuel Passey, Richard Colebrook, David Elcock, Priscilla Mhembere, Jayne Rankin, Yee Yin Cheng, Chris Clulow, Jo Stickley, Anne Carter, Alison Stephens, Elizabeth Buckingham, Laura Price, Ryan Jones, Andy Taylor, Maria Ochoa-Ferraro, Harriette Beard, Jeremy Corfe, Jocelyn Keshet-Price, Deidre Fottrell-Gould, Gill Foot, Lisa Hudig, Karen Convery, Martyn Oliver, Hannah Neil, Georgina Randell, Melanie Maxwell, Kavitha Kuntumalla, Pushpaj Gajendragadkar, James Wu, Danielle Huckle, Stephen Petley, Nadine Jones, Karen Rahilly, Gail Williams, Margaret Coakley, Laura Jones, Dominic Manetta-Jones, Sara Churchill, Laura Fulton, Suyogi Jigajinni, Emma Collins, Fillipa Santos, Noah John, Abhilash Das, Christopher Manville, Tom Abbott, Hester Carter, Lina Kanapeckaite, Gavin Stead, Jonathan Holmes, Amy Ireson, Edward Gill, Stephanie Kwok, Alastair Duncan, Hannah Greenlee, Ian Venables, Rose Jama, Iain Moppett, Cecilia Peters, Lucy Ryan, Louise Conner, Megan Meredith, Amy Clark, Abi Noah, Louise Potter, Will Lindsay, Jaina Parmar, Dan Harvey, David Evans, Marc Chikhani, Ben Lowe, Kevin O’Donoghue, Avninder Chana, Rachel Roke, Ioannis Tsagurnis, Harvey Dymond, David Sleep, Kristina Owens, Rachel Beer, Dawn Simmons, Donna Cotterill, Ime Eka, Sandra Beech, Pei Jean Ong, David Ritchie, Susan Wilkinson, Matthew Butler, David Crossley, Victoria Van Der Schyff, Irum Ghazanfar, Andrew Mawer, Ana Almeida, Lucy Duggal, Jonathan Lightfoot, Anna Simpson, Susan O’Connell, Tom Rennison, Robert Thompson, Susan Fowler, Sandra Pirie, Patricia Cochrane, David Nesvadba, Patrice Forget, Pauline Ganley, Jennifer Noble, Amanda Coutts, Sue Jackson, Tim Prescott, William Smith, Anne Harrison, Emily Omuwie, Rachel Johnson, Jennifer Evans, Rebecca Rudd, Isobel Loeffler, Catarina Veiga, Poh Choo Teoh, Samuel Chambers, Oleg Bumbac, Ross Holcombe-Law, Alexandria Page, Paul Jackson, Daniel George, Tess Wilkinson, Daniel Kirkin, Michaela Lloyd, Leanne Smith, Amie Reddy, William McCaig, Harriet Murrant, Ammara Masoud, Mia Davis, Debasis Pradhan, Joanne Rudkin, Matthew Byrne, Georgios Tsinaslaniois, Vasileios Bafitis, Christopher Black, Cassandra George, Marketa Keltos, Maria Letts, Victoria Allinson, Angela Foulds, Sophie Gittus, Lakshmi Aneesh, Ayman Nash, Prathiban Kumar, James Graham, Andrew Donnaly, Martin Grigg, Ariana Singh, Aastha Chawla, Calum McGrady, Nicola Walker, Christopher Brennan

General improvements versus interruptive or non-interruptive alerts in the blood order set: study protocol for a randomized control trial to improve packed red blood cell utilization

Neelam Mistry, Vanessa Richardson, Evan Carey, Samuel Porter, Sharon Pincus, Sylvie Novins-Montague, Megan Elmer, Chen-Tan Lin, P. Michael Ho, Tyler Anstett

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Evaluation of a community-based integrated care model (CIE) for frail older people in rural Foshan, China: study protocol for a stepped-wedge cluster randomized controlled trial {1}

Fengjiao Xie, Shuang Wen, Aiwen Deng, Jianhao Chen, Ribo Xiong

Statistical analysis plan for HOMESIDE: a randomised controlled trial for home-based family caregiver-delivered music and reading interventions for people living with dementia

Vanessa Pac Soo, Felicity A. Baker, Tanara Vieira Sousa, Helen Odell-Miller, Karette Stensæth, Thomas Wosch, Anna A. Bukowska, Jeanette Tamplin, Nicola Lautenschlager, Sabine Braat, Karen E. Lamb

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Fukushima study for Engaging people with type 2 Diabetes in Behaviour Associated Change (FEEDBACK): study protocol for a cluster randomised controlled trial

Thomas Rouyard, Mei Endo, Ryota Nakamura, Michiko Moriyama, Maham Stanyon, Satoshi Kanke, Koki Nakamura, Cynthia Chen, Yasushi Hara, Masako Ii, Ryuki Kassai

Efficacy of dapagliflozin in the treatment of HFrEF with obstructive sleep apnea syndrome (DAHOS study): study protocol for a multicentric, prospective, randomized controlled clinical trial

Liang Xie, Songsong Song, Shengnan Li, Qin Wei, Hong Liu, Chao Zhao, Fuchao Yu, Jiayi Tong

Effectiveness of motor control exercise, aerobic walking, and muscle strengthening programs in improving outcomes in a subgroup of population with chronic low back pain positive for central sensitization: a study protocol for a randomized controlled trial

G. Shankar Ganesh, Abdur Raheem Khan, Sakti Prasad Das, Ashfaque Khan, Raee S. Alqhtani, Adel Alshahrani, Mohammad Abdulrehman Mohammad Jarrar, Hashim Ahmed

Intratracheal budesonide mixed with surfactant to increase survival free of bronchopulmonary dysplasia in extremely preterm infants: study protocol for the international, multicenter, randomized PLUSS trial

Brett J. Manley, C. Omar F. Kamlin, Susan Donath, Li Huang, Pita Birch, Jeanie L. Y. Cheong, Peter A. Dargaville, Jennifer A. Dawson, Lex W. Doyle, Susan E. Jacobs, Rodney Wilson, Peter G. Davis, Christopher J. D. McKinlay

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The impact of the COVID-19 pandemic on ICU clinical trials: a description of one research team’s experience

Linda L. Chlan, Mary Fran Tracy, Jessica Ask, Amos Lal, Jay Mandrekar

A health-system-embedded deprescribing intervention targeting patients and providers to prevent falls in older adults (STOP-FALLS trial): study protocol for a pragmatic cluster-randomized controlled trial

Benjamin H. Balderson, Shelly L. Gray, Monica M. Fujii, Kanichi G. Nakata, Brian D. Williamson, Andrea J. Cook, Robert Wellman, Mary Kay Theis, Cara C. Lewis, Dustin Key, Elizabeth A. Phelan

The effectiveness of a computer-aided system in improving the detection rate of gastric neoplasm and early gastric cancer: study protocol for a multi-centre, randomized controlled trial

Zehua Dong, Yijie Zhu, Hongliu Du, Junxiao Wang, Xiaoquan Zeng, Xiao Tao, Ting Yang, Jiamin Wang, Mei Deng, Jun Liu, Lianlian Wu, Honggang Yu

Effects of programmed flexor–extensor alternating electrical acupoint stimulation on upper limb motor functional reconstruction after stroke: study protocol for a double-blind, randomized controlled trial

Yang Liu, Xu Dong, Hong Huo, Liyuan Feng, Dan Tong, Jiahui Liu, Hongyan Zhang, Yingkang Zheng, Shuai Wang, Dongyan Wang

EnGraft: a multicentre, open-label, randomised, two-arm, superiority study protocol to assess bioavailability and practicability of Envarsus® versus Advagraf™ in liver transplant recipients

D. S. Wöhl, B. James, M. Götz, F. Brennfleck, I. Holub-Hayles, I. Mutzbauer, S. Baccar, S. M. Brunner, E. K. Geissler, H. J. Schlitt, Florian W. R. Vondran, Uta Herden, Jens Mittler, Ulf Peter Neumann, Silvio Nadalin, Andreas A. Schnitzbauer, Falk Rauchfuß, Felix Braun, Katharina Willuweit, Johann Pratschke, Thomas Berg, Thomas Vogel, Uta Merle, Roland Croner

Comparing adherence to MDR-TB treatment among patients on self-administered therapy and those on directly observed therapy: non-inferiority randomized controlled trial

Clara Wekesa, Christine Sekaggya-Wiltshire, Stella Zawedde Muyanja, Ivan Lume, Maria Sarah Nabaggala, Rosalind Parkes-Ratanshi, Susan Adakun Akello

Central venous stenosis after subclavian versus internal jugular dialysis catheter insertion (CITES) in adults in need of a temporary central dialysis catheter: study protocol for a two-arm, parallel-group, non-inferiority randomised controlled trial

Ola Borgquist, Leila Naddi, Gracijela Božović, Matthias Hellberg, Martin Annborn, Fredrik Sjövall, Maria Adrian, Eva Hettinger, Pia Sjöberg, Thomas Kander

Cardiovascular implications and physical activity in middle-aged and older adults with a history of COVID-19 (CV COVID): a protocol for a randomised controlled trial

Mushidur Rahman, Sophie L. Russell, Nduka C. Okwose, Olivia M. A. Hood, Amy E. Harwood, Gordon McGregor, Stuart M. Raleigh, Hardip Sandhu, Laura C. Roden, Helen Maddock, Prithwish Banerjee, Djordje G. Jakovljevic

Implementation of a batched stepped wedge trial evaluating a quality improvement intervention for surgical teams to reduce anastomotic leak after right colectomy

Mary L. Venn, Charles H. Knowles, Elizabeth Li, James Glasbey, Dion G. Morton, Richard Hooper

  • Open Access
  • Care
  • Study protocol

Concept and study protocol of the process evaluation of a pragmatic randomized controlled trial to promote physical activity in outpatients with heterogeneous mental disorders—the ImPuls study

David Victor Fiedler, Stephanie Rosenstiel, Johanna-Marie Zeibig, Britta Seiffer, Jana Welkerling, Anna Katharina Frei, Thomas Studnitz, Julia Baur, Florian Helmhold, Andreas Ray, Eva Herzog, Keisuke Takano, Tristan Nakagawa, Saskia Kropp, Sebastian Franke, Stefan Peters, Anna Lena Flagmeier, Lena Zwanzleitner, Leonie Sundmacher, Ander Ramos-Murguialday, Martin Hautzinger, Thomas Ehring, Gorden Sudeck, Sebastian Wolf

  • Open Access
  • Care
  • Study protocol

Virtual family-centered hospital rounds in the neonatal intensive care unit: protocol for a cluster randomized controlled trial

Jennifer L. Rosenthal, Daniel J. Tancredi, James P. Marcin, Audriana Ketchersid, Elva T. Horath, Erika N. Zerda, Trevor R. Bushong, Daniel S. Merriott, Patrick S. Romano, Heather M. Young, Kristin R. Hoffman

Comparison of postoperative analgesic effects of erector spinae plane block and quadratus lumborum block in laparoscopic liver resection: study protocol for a randomized controlled trial

Yu Jeong Bang, Ji-Hye Kwon, RyungA Kang, Gaab Soo Kim, Ji Seon Jeong, Myungsuk Kim, Gyu-Seong Choi, Jong Man Kim, Justin Sangwook Ko

  • Open Access
  • Opioids
  • Study protocol

The Child Healthcare at MATER Pediatric Study (CHAMPS): a 2-arm cluster randomized control trial of group well child care for mothers in treatment for opioid use disorder and their children

Vanessa L. Short, Diane J. Abatemarco, Erica Sood, Dennis J. Hand, Meghan Gannon, Jobayer Hossain, Neera K. Goyal

Remote blood pressure monitoring in high risk pregnancy — study protocol for a randomised controlled trial (REMOTE CONTROL trial)

Theepika Rajkumar, Jill Freyne, Marlien Varnfield, Kenny Lawson, Kaley Butten, Renuka Shanmugalingam, Annemarie Hennessy, Angela Makris

Correction: An international, stepped wedge, cluster-randomized trial investigating the 0/1-h algorithm in suspected acute coronary syndrome in Asia: the rational of the DROP-Asian ACS study

Kenji Inoue, Jack Tan Wei Chieh, Lim Chiw Yeh, Shuo-Ju Chiang, Arintaya Phrommintikul, Pannipa Suwanasom, Sazzli Kasim, Bakhtiar Ahmad, Alzamani Mohammad Idrose, Farina Mohd Salleh, Shunsuke Oyamada, Yohei Hirano, Shohei Ouchi, Moriyuki Terakura, Naoyuki Yokoyama, Ken Kozuma, Mamoru Nanasato, Ryosuke Higuchi, Kazuhiko Yumoto, Tomoyuki Fukuzawa, Issei Shimada, Evangelos Giannitsis, Raphael Twerenbold, Tohru Minamino

The effectiveness of the serious game “Broodles” for siblings of children with intellectual disabilities and/or visual impairment: study protocol for a randomized controlled trial

Linda K. M. Veerman, Agnes M. Willemen, Suzanne D. M. Derks, Anjet A. J. Brouwer-van Dijken, Paula S. Sterkenburg

Establishing the safety of selective digestive decontamination within the ICU population: a bridge too far?

James C. Hurley

PRECYCLE: multicenter, randomized phase IV intergroup trial to evaluate the impact of eHealth-based patient-reported outcome (PRO) assessment on quality of life in patients with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer treated with palbociclib and an aromatase inhibitor or palbociclib and fulvestrant

Tom Degenhardt, Peter A. Fasching, Diana Lüftner, Volkmar Müller, Christoph Thomssen, Christian Schem, Isabell Witzel, Thomas Decker, Hans Tesch, Sherko Kümmel, Christoph Uleer, Rachel Wuerstlein, Oliver Hoffmann, Mathias Warm, Norbert Marschner, Timo Schinköthe, Ronald E. Kates, Johannes Schumacher, Burkhard Otremba, Matthias Zaiss, Nadia Harbeck, Marcus Schmidt

The effects of an e-health brisk walking intervention in increasing moderate-to-vigorous physical activity in physically inactive older people with cognitive frailty: study protocol for a randomized controlled trial

Rick Yiu Cho Kwan, Justina Yat Wa Liu, Paul Hong Lee, Olive Suk Kan Sin, Julia Sze Wing Wong, Mei Rosemary Fu, Lorna Kwai Ping Suen

Oral nicotinamide mononucleotide (NMN) to treat chronic insomnia: protocol for the multicenter, randomized, double-blinded, placebo-controlled trial

Xiangyang Gao, Junhua Li, Sanping Xu, Xueying Li, Xicheng Wang, Yongli Li, Yan Huang, Shaohui Liu, Qiang Zeng

Quick Epidural Top-up with Alkalinized Lidocaine for emergent caesarean delivery (QETAL study): protocol for a randomized, controlled, bicentric trial

Thomas Lechat, Thomas d’Aprigny, Jérémy Henriot, Jill Arthur, Dienabou Sylla, Antoine Bénard, Karine Nouette-Gaulain

The PRESIDE (PhaRmacogEnomicS In DEpression) Trial: a double-blind randomised controlled trial of pharmacogenomic-informed prescribing of antidepressants on depression outcomes in patients with major depressive disorder in primary care

Sibel Saya, Patty Chondros, Anastasia Abela, Cathrine Mihalopolous, Mary Lou Chatterton, Jane Gunn, Timothy F. Chen, Thomas M. Polasek, Elise Dettmann, Rachel Brooks, Michelle King, Luke Spencer, Pavithran Alphonse, Shakira Milton, Georgia Ramsay, Zoe Siviour, Jamie Liew, Philip Ly, Matthew Thoenig, Raushaan Seychell, Floriana La Rocca, Luke B. Hesson, Nydia Mejias, Terri Sivertsen, Melanie Anne Galea, Chad Bousman, Jon Emery

  • Open Access
  • Study protocol

Statistical analysis plans for two randomised controlled trials of the Narrative Experiences Online (NEON) Intervention: impact of receiving recorded mental health recovery narratives on quality of life in people experiencing psychosis (NEON) and people experiencing non-psychosis mental health problems (NEON-O)

Clare Robinson, Chris Newby, Stefan Rennick-Egglestone, Joy Llewellyn-Beardsley, Fiona Ng, Rachel A. Elliott, Mike Slade

Optimization of smartphone psychotherapy for depression and anxiety among patients with cancer using the multiphase optimization strategy (MOST) framework and decentralized clinical trial system (SMartphone Intervention to LEssen depression/Anxiety and GAIN resilience: SMILE AGAIN project): a protocol for a randomized controlled trial

Megumi Uchida, Toshiaki A Furukawa, Takuhiro Yamaguchi, Fuminobu Imai, Kanae Momino, Fujika Katsuki, Naomi Sakurai, Tempei Miyaji, Masaru Horikoshi, Hiroji Iwata, Sadamoto Zenda, Tsuguo Iwatani, Asao Ogawa, Akira Inoue, Masakazu Abe, Tatsuya Toyama, Yosuke Uchitomi, Hiromichi Matsuoka, Hisashi Noma, Tatsuo Akechi

  • Open Access
  • Methodology

How to reach agreement: the impact of different analytical approaches to Delphi process results in core outcomes set development

James Webbe, Benjamin Allin, Marian Knight, Neena Modi, Chris Gale

  • Open Access
  • Study protocol

A randomized controlled trial evaluating the effects of motivational interviewing in new hearing aid users (MI-HAT): study protocol for a randomized controlled trial

Alice Q. Liu, Printha Wijesinghe, Melissa Lee, Carol Lau, Jane Sun, Desmond A Nunez

  • Open Access
  • Correction

Correction: Favipiravir and/or nitazoxanide: a randomized, double-blind, placebo-controlled trial of early therapy in COVID-19 in health workers, their household members, and patients treated at IMSS (FANTAZE)

Tania A. Smith, Carlos Hoyo-Vadillo, Akosua Agyeman Adom, Liliana Favari-Perozzi, Silke Gastine, Hakim-Moulay Dehbi, Beatriz Villegas-Lara, Eduardo Mateos, Yessica Sara Pérez González, Maria D. Navarro-Gualito, Alejandra S. Cruz-Carbajal, Miguel A. Cortes-Vazquez, Carolina Bekker-Méndez, Charmina Aguirre-Alvarado, Gisela Aguirre-Gil, Lucero Delgado-Pastelin, Andrew Owen, David Lowe, Joseph Standing, Jorge Escobedo

Mechanical hyperinflation maneuver and intracranial compliance of critical neurological patients: protocol for a randomized controlled equivalence trial

Daniela de Almeida Souza, Marina Wolff Branco, Hipólito Carraro Junior, Ana Márcia Delattre Zocolotti, Sibele Yoko Mattozo Takeda, Silvia Valderramas

  • Open Access
  • Study protocol

Regulating effect of virtual reality restorative environment on prefrontal cortex dysfunction after night shifts in medical staff: an fNIRS study protocol for a randomized controlled trial in Dalian, China

Xiaofeng Huang, Cuiyan Song, Yingjun Jiang, Zhanhua Liang, Xiaotong Qu, Shaoyan Fu

Low-Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN): protocol for a hybrid type 1 effectiveness implementation trial

Edith E. Holloway, Shikha Gray, Cathrine Mihalopoulos, Vincent L. Versace, Roslyn Le Gautier, Mary Lou Chatterton, Virginia Hagger, Jennifer Halliday, Kim Henshaw, Benjamin Harrap, Sarah Manallack, Taryn Black, Natasha Van Bruggen, Carolyn Hines, Adrienne O’Neil, Timothy C. Skinner, Jane Speight, Christel Hendrieckx

Efficacy of stretching exercises versus transcranial direct current stimulation (tDCS) on task performance, kinematic and electroencephalography (EEG) spectrum in subjects with slump posture: a study protocol

Zahra Abdollahzade, Mohammad Reza Hadian, Roya Khanmohammadi, Saeed Talebian

WONDER-01: immediate necrosectomy vs. drainage-oriented step-up approach after endoscopic ultrasound-guided drainage of walled-off necrosis—study protocol for a multicentre randomised controlled trial

Tatsuya Sato, Tomotaka Saito, Mamoru Takenaka, Takuji Iwashita, Hideyuki Shiomi, Toshio Fujisawa, Nobuhiko Hayashi, Keisuke Iwata, Akinori Maruta, Tsuyoshi Mukai, Atsuhiro Masuda, Saburo Matsubara, Tsuyoshi Hamada, Tadahisa Inoue, Hiroshi Ohyama, Masaki Kuwatani, Hideki Kamada, Shinichi Hashimoto, Toshiyasu Shiratori, Reiko Yamada, Hirofumi Kogure, Takeshi Ogura, Kazunari Nakahara, Shinpei Doi, Kenji Chinen, Hiroyuki Isayama, Ichiro Yasuda, Yousuke Nakai

Comparison of landiolol and amiodarone for the treatment of new-onset atrial fibrillation after cardiac surgery (FAAC) trial: study protocol for a randomized controlled trial

Edouard Caspersen, Pierre-Grégoire Guinot, Bertrand Rozec, Jean-Ferréol Oilleau, Jean-Luc Fellahi, Philippe Gaudard, Emmanuel Lorne, Yazine Mahjoub, Emmanuel Besnier, Mouhamed Djahoum Moussa, Nicolas Mongardon, Jean-Luc Hanouz, Anaïs R. Briant, Laure Peyro Saint Paul, Clémence Tomadesso, Jean-Jacques Parienti, Richard Descamps, Alina Denisenko, Marc-Olivier Fischer

  • Open Access
  • Malaria
  • Study protocol

Evaluation of the protective efficacy of Olyset®Plus ceiling net on reducing malaria prevalence in children in Lake Victoria Basin, Kenya: study protocol for a cluster-randomized controlled trial

Wataru Kagaya, Chim W. Chan, James Kongere, Bernard N. Kanoi, Mtakai Ngara, Protus Omondi, Ashley Osborne, Laura Barbieri, Achyut Kc, Noboru Minakawa, Jesse Gitaka, Akira Kaneko

Study protocol for a randomised controlled trial to determine the effectiveness of a mHealth application as a family supportive tool in paediatric otolaryngology perioperative process (TONAPP)

Raffaella Dobrina, Andrea Cassone, Margherita Dal Cin, Luca Ronfani, Manuela Giangreco, Silvana Schreiber, Sara Zanchiello, Anja Starec, Laura Brunelli, Liza Vecchi Brumatti, Livia Bicego

HELP — Heidelberg decision aid for lung cancer patients: a randomized controlled clinical trial

Nicole Deis, Laura Unsöld, Anja Siegle, Johannes Krisam, Michael Thomas, Matthias Villalobos

A randomised controlled trial of compression therapies for the treatment of venous leg ulcers (VenUS 6): study protocol for a pragmatic, multicentre, parallel-group, three-arm randomised controlled trial

C. E. Arundel, C. Welch, P. Saramago, U. Adderley, R. Atkinson, I. Chetter, N. Cullum, T. Davill, J. Griffiths, C. Hewitt, C. Hirst, M. Kletter, J. Mullings, G. Roberts, B. Smart, M. Soares, P. Stather, L. Strachan, N. Stubbs, D. J. Torgerson, J. Watson, S. Zahra, J. Dumville

  • Open Access
  • Cough
  • Study protocol

Effect of continuous measurement and adjustment of endotracheal tube cuff pressure on postoperative sore throat in patients undergoing gynecological laparoscopic surgery: study protocol for a randomized controlled trial

Chen Wang, Xiang Yan, Chao Gao, Simeng Liu, Di Zhang, Jia Jiang, Anshi Wu

Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. coli Infection: a multinational embedded cluster crossover randomized trial (the HIKO STEC trial)

Stephen B. Freedman, David Schnadower, Myka Estes, T. Charles Casper, Stuart L. Goldstein, Silviu Grisaru, Andrew T. Pavia, Benjamin S. Wilfond, Melissa Metheney, Kadyn Kimball, Phillip I. Tarr

  • Open Access
  • Study protocol

Evaluating the effectiveness of lateral postural management for breech presentation: study protocol for a randomized controlled trial (BRLT study)

Hiroki Shinmura, Takashi Matsushima, Asako Watanabe, Honglian Shi, Asako Nagashima, Ayako Takizawa, Mayu Yamada, Eika Harigane, Youhei Tsunoda, Ryuhei Kurashina, Go Ichikawa, Shunji Suzuki

  • Open Access
  • Study protocol

N-acetyl-L-leucine for Niemann-Pick type C: a multinational double-blind randomized placebo-controlled crossover study

T Fields, T M. Bremova, I Billington, GC Churchill, W Evans, C Fields, A Galione, R Kay, T Mathieson, K Martakis, M Patterson, F Platt, M Factor, M Strupp

The impact of Hafnia alvei HA4597™ on weight loss and glycaemic control after bariatric surgery — study protocol for a triple-blinded, blocked randomized, 12-month, parallel-group, placebo-controlled clinical trial

Shámila Ismael, Carlos Vaz, Catarina Durão, Marta P. Silvestre, Conceição Calhau, Diana Teixeira, Cláudia Marques

Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers—study protocol for the randomised controlled TRIANGLE trial

Patrick Heger, Thilo Hackert, Markus K. Diener, Manuel Feißt, Christina Klose, Colette Dörr-Harim, Friedhelm Möhlenbrock, Markus W. Büchler, André L. Mihaljevic

Biomarker-guided duration of antibiotic treatment in children hospitalised with confirmed or suspected bacterial infection: statistical analysis plan for the BATCH trial and PRECISE sub-study

Simon M. Schoenbuchner, Chao Huang, Cherry-Ann Waldron, Emma Thomas-Jones, Kerenza Hood, Enitan D. Carrol, Philip Pallmann

Study protocol for The GOAL Trial: comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals—a cluster randomised controlled trial

B Logan, AK Viecelli, DW Johnson, EM Aquino, J Bailey, TA Comans, LC Gray, CM Hawley, LE Hickey, M Janda, A Jaure, MD Jose, E Kalaw, C Kiriwandeniya, M Matsuyama, G Mihala, KH Nguyen, E Pascoe, JD Pole, KR Polkinghorne, D Pond, R Raj, DM Reidlinger, N Scholes-Robertson, J Varghese, G Wong, RE Hubbard, Graham Buckle, Phil Carswell, Joanne Cerni, Michael G. Collins, Amanda Elms, John Fanning, Karen Fischer, Adam Flavell, Emily H. Gordon, Natalie Grainer, Stella Green, Chandana Guha, Samantha Hand, Moira Hibbs, Bronwyn Hockley, Rachael Irvine, Ibrahim Ismail, Shilpanjali Jesudason, George Kan, Debbie Kennedy, Vinod Khelgi, Shannon Kokoszka, Anoushka Krishnan, Janelle Leadbitter, Diana Leary, Angela Makris, Khalilah Katherine Marquez, David McIntyre, Penelope Murie, Karina Murphy, Nancye Peel, Xiaodan Qiu, Madeleine Rapisardi, Matthew A. Roberts, Simon D. Roger, Mona Saade, Shaundeep Sen, Gerald Tataro, Brioney Weaver, Paul A. Yates, Belinda Yip

Ultrasound-guided supraclavicular block versus Bier block for emergency reduction of upper limb injuries: a protocol for an open-label, non-inferiority, randomised controlled trial

Henry Tsao, Christopher Tang, Mark Trembath, Philip Jones, Peter J. Snelling

  • Open Access
  • Study protocol

Development of an international core outcome set for treatment trials in necrotizing enterocolitis—a study protocol

Daphne H. Klerk, Otis C. van Varsseveld, Martin Offringa, Neena Modi, Martin Lacher, Augusto Zani, Mikko P. Pakarinen, Antti Koivusalo, Ingo Jester, Marie Spruce, Joep P. M. Derikx, Roel Bakx, Amine Ksia, Marijn J. Vermeulen, Elisabeth M. W. Kooi, Jan B. F. Hulscher

Euthyroidectomy under local versus general anesthesia in health camp settings in Uganda: a protocol for randomized prospective equivalence single-blind controlled trial

Umaru Kabuye, Jane Odubu Fualal, Herman Lule

Transnasal Humidified Rapid Insufflation Ventilatory Exchange in children requiring emergent intubation (Kids THRIVE): a statistical analysis plan for a randomised controlled trial

Shane George, Kristen Gibbons, Tara Williams, Susan Humphreys, Ben Gelbart, Renate Le Marsney, Simon Craig, David Tingay, Arjun Chavan, Andreas Schibler, Joanna Cronin, Kylie Pearson, Katie Rasmussen, Jason Acworth, Leah Hickey, Carmel Delzoppo, Elizabeth Perkins, Felix Oberender, Jessica Waghorn, Courtney McCahill, Nitesh Singhal, Gail Harper, Subodh Ganu, Georiga Letton, Simon Erikson, Hannah Thomson, Luregn J. Schlapbach, Juerg Burren, Elisa Zimmerman, Anusha Ganeshalingham, Stuart Dalziel, Clarie Sherring

  • Open Access
  • Review

Reporting of PPI and the MCID in phase III/IV randomised controlled trials—a systematic review

Joseph Brennan, Michael T. C. Poon, Edward Christopher, Olivia Fulton, Carol Porteous, Paul M. Brennan

Publisher Correction: Effectiveness of motor control exercise, aerobic walking, and muscle strengthening programs in improving outcomes in a subgroup of population with chronic low back pain positive for central sensitization: a study protocol for a randomized controlled trial

G. Shankar Ganesh, Abdur Raheem Khan, Sakti Prasad Das, Ashfaque Khan, Raee S. Alqhtani, Adel Alshahrani, Mohammad Abdulrehman Mohammad Jarrar, Hashim Ahmed

The clinical effects of modified tinnitus relieving sound (MTRS) for chronic tinnitus: protocol for a randomized controlled trial

Dongmei Tang, Jinghan Wang, Xiaopei Yu, Huiqian Yu

  • Open Access
  • Research

Cross-sectional analysis characterizing the use of rank preserving structural failure time in oncology studies: changes to hazard ratio and frequency of inappropriate use

Vinay Prasad, Myung Sun Kim, Alyson Haslam

Treatment of haemorrhoids: rubber band ligation or sclerotherapy (THROS)? Study protocol for a multicentre, non-inferiority, randomised controlled trial

J. Y. van Oostendorp, T. C. Sluckin, I. J. M. Han-Geurts, S. van Dieren, R. Schouten

Effects of adjuvant application of corticosteroid and ozone after ultrasound-guided puncture and lavage for the treatment of rotator cuff calcific tendinitis: study protocol for a non-inferiority randomized controlled trial

Jing Dong, Lan Zhang, Haibin Jia, Yuanjiang Zhu, Rui Xiang, Peiyu Li

Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery — protocol of a randomized controlled trial

Pauliana C. S. Mendes, Tatiana B. Fretta, Milena F. C. Camargo, Patricia Driusso, Cristine Homsi Jorge

  • Open Access
  • Study protocol

Effectiveness of a theory-based educational intervention on work-related musculoskeletal disorders preventive behaviors among assembly-line female workers: a study protocol for a randomized controlled trial

Zakieh Sadat Hosseini, Sedigheh Sadat Tavafian, Omran Ahmadi, Reza Maghbouli

Minocycline for sporadic and hereditary cerebral amyloid angiopathy (BATMAN): study protocol for a placebo-controlled randomized double-blind trial

S. Voigt, E. A. Koemans, I. Rasing, E. S. van Etten, G. M. Terwindt, F. Baas, K. Kaushik, A. C. G. M. van Es, M. A. van Buchem, M. J. P. van Osch, M. A. A. van Walderveen, C. J. M. Klijn, M. M. Verbeek, L. van der Weerd, M. J. H. Wermer

End-ischemic hypothermic oxygenated perfusion for extended criteria donors in liver transplantation: a multicenter, randomized controlled trial—HOPExt

Pierre Pradat, Solene Pantel, Marianne Maynard, Laure Lalande, Sylvie Thevenon, Rene Adam, Marc-Antoine Allard, Fabien Robin, Michel Rayar, Emmanuel Boleslawski, Olivier Scatton, Mircea Chirica, François Faitot, Philippe Bachellier, Olivier Soubrane, Kayvan Mohkam, Jean-Yves Mabrut, Mickaël Lesurtel

More efficient and inclusive time-to-event trials with covariate adjustment: a simulation study

Raphaëlle Momal, Honghao Li, Paul Trichelair, Michael G. B. Blum, Félix Balazard

  • Open Access
  • Study protocol

Providing office workers with height-adjustable workstation to reduce and interrupt workplace sitting time: protocol for the Stand Up for Healthy Aging (SUFHA) cluster randomized controlled trial

Pedro B. Júdice, Hélio Silva, Sabrina C. Teno, Patrícia Monteiro, Marlene N. Silva, Eliana V. Carraça, Inês Santos, Sara Pereira, Filipe Luz, Patrícia C. Viegas, Jorge Oliveira, Isabel F. Santos, António L. Palmeira

A phase IIb, open-label, randomized controlled dose ranging multi-centre trial to evaluate the safety, tolerability, pharmacokinetics and exposure-response relationship of different doses of delpazolid in combination with bedaquiline delamanid moxifloxacin in adult subjects with newly diagnosed, uncomplicated, smear-positive, drug-sensitive pulmonary tuberculosis

A Dierig, M Hoelscher, S Schultz, L Hoffmann, A Jarchow-MacDonald, EM Svensson, L Te Brake, R Aarnoutse, M Boeree, TD McHugh, LM Wildner, X Gong, PPJ Phillips, LT Minja, N Ntinginya, S Mpagama, A Liyoyo, RS Wallis, M Sebe, FA Mhimbira, B Mbeya, M Rassool, L Geiter, YL Cho, N Heinrich

Improvement of synaptic plasticity and cognitive function in RASopathies—a monocentre, randomized, double-blind, parallel-group, placebo-controlled, cross-over clinical trial (SynCoRAS)

Nikolai H. Jung, Silvia Egert-Schwender, Beate Schossow, Victoria Kehl, Ute Wahlländer, Louisa Brich, Viktoria Janke, Christiane Blankenstein, Martin Zenker, Volker Mall

Global posture reeducation compared with segmental muscle stretching exercises in the treatment of fibromyalgia: a randomized controlled trial

Luciana Akemi Matsutani, Adriana de Sousa do Espírito Santo, Marina Ciscato, Susan Lee King Yuan, Amelia Pasqual Marques

Whose knowledge counts? Involving communities in intervention and trial design using community conversations

Rochelle A. Burgess, Funmilayo Shittu, Agnese Iuliano, Ibrahim Haruna, Paula Valentine, Ayobami Adebayo Bakare, Tim Colbourn, Hamish R. Graham, Eric D. McCollum, Adegoke G. Falade, Carina King, Tahlil Ahmed, Samy Ahmar, Christine Cassar, Adamu Isah, Adams Osebi, Abdullahi Magama, Ibrahim Seriki, Temitayo Folorunso Olowookere, Matt McCalla, Obioma Uchendu, Julius Salako, Damola Bakare, Omotayo Olojede

Effects of dexmedetomidine at different dosages on perioperative haemodynamics and postoperative recovery quality in elderly patients undergoing hip replacement surgery under general anaesthesia: a randomized controlled trial

Haitong Liu, Mingjie Gao, Yongfeng Zheng, Caixia Sun, Qinyuan Lu, Donghua Shao

Protocol of a prospective multicenter randomized controlled trial of robot-assisted stereotactic lesioning in the treatment of focal drug-resistant epilepsy

Mingkun Gong, Ke Xu, Yongzhi Shan, Yihe Wang, Chao Zhang, Xiongfei Wang, Jian Zhou, Yuguang Guan, Tianfu Li, Guoming Luan

Safety and efficacy in pediatric secondary intraocular lens implantation, in-the-bag versus sulcus implantation: a multicenter, single-blinded randomized controlled trial

Yingshi Zou, Ling Jin, Bo Qu, Hui Chen, Mingbing Zeng, Xia Li, Xinhua Liu, Lixia Luo, Zhenzhen Liu, Yizhi Liu

Efficacy of low-intensity pulsed ultrasound for the treatment of viral pneumonia: study protocol for a randomized controlled trial

Xiao Li, Wen Li, Lianjie Sun, Junyi Ren, Ying Xu, Yuanyi Zheng, Wenkun Bai

  • Open Access
  • Study protocol

A short, animated storytelling video about sodium intake as a major cardiovascular risk factor and recommendations for a healthy diet: an online, randomized, controlled trial

A Supady, K Nguyen, M Abd El Aziz, C Überreiter, T Bärnighausen, M Adam

  • Open Access
  • Commentary

Further considerations for placebo controls in surgical trials

Marion K. Campbell, David J. Beard, Jane M. Blazeby, Sian Cousins, Ahmed Ahmed, Rasha Al-Lamee, David B. Anderson, Natalie Blencowe, Jonathan Cook, Brian H. Cuthbertson, Manuela Ferreira, Matt Gardiner, Katie Gillies, José Miola, John Norrie, Tom Pinkney, Jonathan Pugh, Maroeska Rovers, Deborah Stocken, Matt Westmore

Effect of interscalene brachial plexus block with dexmedetomidine and ropivacaine on postoperative analgesia in patients undergoing arthroscopic shoulder surgery: a randomized controlled clinical trial

Hengfei Luan, Conghui Hao, Han Li, Xiaobao Zhang, Zhibin Zhao, Pin Zhu

Compassion-focused therapy (CFT) for the reduction of the self-stigma of mental disorders: the COMpassion for Psychiatric disorders, Autism and Self-Stigma (COMPASS) study protocol for a randomized controlled study

M. Riebel, O. Rohmer, E. Charles, F. Lefebvre, S. Weibel, L. Weiner

Clinical effectiveness of pulsed electromagnetic field therapy as an adjunct treatment to eccentric exercise for Achilles tendinopathy: a randomised controlled trial

Violet Man-Chi Ko, Xin He, Sai-Chuen Fu, Patrick Shu-Hang Yung, Samuel Ka-Kin Ling

Differential target multiplexed spinal cord stimulation using a paddle-type lead placed at the appropriate site for neuropathic pain after spinal cord injury in patients with past spinal surgical histories: study protocol for an exploratory clinical trial

Takafumi Tanei, Satoshi Maesawa, Yusuke Nishimura, Yoshitaka Nagashima, Tomotaka Ishizaki, Masahiko Ando, Yachiyo Kuwatsuka, Atsushi Hashizume, Shimon Kurasawa, Ryuta Saito

Effect of post-extubation high-flow nasal cannula combined with respiratory training versus conventional oxygen therapy on postoperative pulmonary complications in patients after major abdominal surgery: protocol for a single-centre randomized controlled trial

Biao Jin, Mengjing Yao, Wenjuan Shen, Le Fu, Ping Liu, Xu Zheng, Tiexiang Zhan, Liang Luo

Comparison of the pathological response to 2 or 4 cycles of neoadjuvant CAPOX in II/III rectal cancer patients with low/intermediate risks: study protocol for a prospective, non-inferior, randomized control trial (COPEC trial)

Yu Shen, Wanyue Shi, Cui Huang, Xiaoling Gong, Mingtian Wei, Wenjian Meng, Xiangbing Deng, Ziqiang Wang

Effect of aerobic exercise training on the fat fraction of the liver in persons with chronic hepatitis B and hepatic steatosis: Trial protocol for a randomized controlled intervention trial— The FitLiver study

Sofie Jespersen, Peter Plomgaard, Sten Madsbad, Adam Espe Hansen, Thomas Bandholm, Bente Klarlund Pedersen, Christian Ritz, Nina Weis, Rikke Krogh-Madsen

  • Open Access
  • Correction

Correction: Internet-based stress recovery intervention for adolescents: study protocol for a randomized controlled trial

Paulina Zelviene, Agniete Kairyte, Austeja Dumarkaite, Augustė Nomeikaite, Evaldas Kazlauskas

  • Open Access
  • Research

Patient communication and experiences in cancer clinical drug trials: a mixed-method study at a specialist clinical trials unit

Rowan Forbes Shepherd, Ashleigh Bradford, Marian Lieschke, Kylie Shackleton, Amelia Hyatt

  • Open Access
  • Study protocol

The effect of combined β-lactoglobulin supplementation and resistance exercise training prior to limb immobilisation on muscle protein synthesis rates in healthy young adults: study protocol for a randomised controlled trial

Alix Hughes, Thomas Francis, Lindsey Marjoram, Jessica H. Rooney, Georgina Ellison-Hughes, Ross Pollock, Michael J. Curtis, Angela Cape, Mads Larsen, Bethan E. Phillips, Philip J. Atherton, Kenneth Smith, Oliver C. Witard

Troponin in acute chest pain to risk stratify and guide effective use of computed tomography coronary angiography (TARGET-CTCA): a randomised controlled trial

Kuan Ken Lee, David Lowe, Rachel O’Brien, Ryan Wereski, Anda Bularga, Caelan Taggart, Matthew T. H. Lowry, Amy V. Ferry, Michelle C. Williams, Giles Roditi, John Byrne, Chris Tuck, Denise Cranley, Praveen Thokala, Steve Goodacre, Catriona Keerie, John Norrie, David E. Newby, Alasdair J. Gray, Nicholas L. Mills

  • Open Access
  • Review

Participant retention in paediatric randomised controlled trials published in six major journals 2015–2019: systematic review and meta-analysis

Daisy M. Gaunt, Cat Papastavrou Brooks, Hugo Pedder, Esther Crawley, Jeremy Horwood, Chris Metcalfe

  • Open Access
  • Study protocol

Does closed-loop automated oxygen control reduce the duration of supplementary oxygen treatment and the amount of time spent in hyperoxia? A randomised controlled trial in ventilated infants born at or near term

Ourania Kaltsogianni, Theodore Dassios, Allan Jenkinson, Anne Greenough

  • Open Access
  • Study protocol

Continuous monitoring of patients in and after the acute admission ward to improve clinical pathways: study protocol for a randomized controlled trial (Optimal-AAW)

Sjoerd H. Garssen, Niels Kant, Carlijn A. Vernooij, Gert-Jan Mauritz, Mark V. Koning, Frank H. Bosch, Carine J. M. Doggen

GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures

Billy T. Haonga, Jamieson M. O’Marr, Patrick Ngunyale, Joshua Ngahyoma, Justin Kessey, Ibrahim Sasillo, Patricia Rodarte, Tigist Belaye, Eleni Berhaneselase, Edmund Eliezer, Travis C. Porco, Saam Morshed, David W. Shearer

Bipolar haemostatic forceps versus standard therapy by haemoclip + / − epinephrine injection as initial endoscopic treatment in active non-variceal upper GI bleeding: study protocol for a prospective, randomized multicentre trial (BeBop-Trial)

Daniel Schmitz, Lucas Thielemann, Felix Grassmann

  • Open Access
  • Review

On the use of non-concurrent controls in platform trials: a scoping review

Marta Bofill Roig, Cora Burgwinkel, Ursula Garczarek, Franz Koenig, Martin Posch, Quynh Nguyen, Katharina Hees

  • Open Access
  • Study protocol

Cervical collar use following anterior cervical hybrid surgery: protocol for a prospective randomized, time-controlled trial

Junbo He, Qingyu Liu, Zijiao Yang, Hao Liu, Tingkui Wu, Chen Ding, Kangkang Huang, Beiyu Wang

Intermittent theta-burst stimulation combined with physical therapy as an optimal rehabilitation in Parkinson’s disease: study protocol for a randomised, double-blind, controlled trial

Zhao-hui Jin, Yi-xuan Wang, De-tao Meng, Yi Qin, Yi-nan Duan, Jin-ping Fang, Rui-dan Wang, Yan-jun Liu, Cui Liu, Ping Wang, Hong-jiao Yan, Yi Zhen, Xia An, Ke-ke Chen, Xin Yu, Diyang Lyu, Xiao-Yan Yan, Bo-yan Fang

Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial

Xinyi Xia, Miao Xu, Yunjie Gu, Yangxue Li, Li Li, Jun Yin

PYloroplasty versus No Intervention in GAstric REmnant REconstruction after Oesophagectomy: study protocol for the PYNI-GAREREO phase III randomized controlled trial

Naoya Okada, Yoshihiro Kinoshita, Shoji Nishihara, Takuma Kurotaki, Aya Sato, Kotaro Kimura, Hiroki Kushiya, Kazufumi Umemoto, Shotaro Furukawa, Takumi Yamabuki, Minoru Takada, Kentaro Kato, Yoshiyasu Ambo, Fumitaka Nakamura

Susceptibility‐guided sequential strategy versus empirical therapy for Helicobacter pylori infection: study protocol for a randomised controlled trial

Kemei Lu, Cuicui Lang, Xuefei Zou, Lina Zang, WeiWei Sang, Qian Feng, Ying Mu, Lifeng Liu, Chunhong Xu, Jingrun Zhao

The value of pre-symptomatic genetic risk assessment for age-related macular degeneration: the Moran AMD Genetic Testing Assessment (MAGENTA) study—a study protocol for a randomized controlled trial

Emmanuel K. Addo, M. Elizabeth Hartnett, Paul S. Bernstein

Postprandial effects of dietary protein source on metabolic responses, appetite, and arterial stiffness indices in overweight and obese men: the study protocol for a randomized crossover clinical trial

Zahra Dehnavi, Ali Jafarzadeh Esfehani, Omolbanin Hajhoseini, Hanieh Barghchi, Aliyeh Ghannadzadeh Yazdi, Zahra Khorasanchi, Mahdi Shadnoush, Reza Rezvani, Habibollah Esmaily, Mohammad Safarian

The impact of high versus standard enteral protein provision on functional recovery following intensive care admission (PRECISE trial): study protocol for a randomized controlled, quadruple blinded, multicenter, parallel group trial in mechanically ventilated patients

Rob J. J. van Gassel, Julia L. M. Bels, Katrien Tartaglia, Bas C. T. van Bussel, Sander M. J. van Kuijk, Adam M. Deane, Zudin Puthucheary, Peter J. M. Weijs, Lilian Vloet, Bert Beishuizen, Ashley De Bie Dekker, Vincent Fraipont, Stoffel Lamote, Didier Ledoux, Clarissa Scheeren, Elisabeth De Waele, Arthur R. H. van Zanten, Dieter Mesotten, Marcel C. G. van de Poll

Effect of xenon on brain injury, neurological outcome, and survival in patients after aneurysmal subarachnoid hemorrhage—study protocol for a randomized clinical trial

Mikael Laaksonen, Jaakko Rinne, Melissa Rahi, Jussi P. Posti, Ruut Laitio, Juri Kivelev, Ilkka Saarenpää, Dan Laukka, Juhana Frösen, Antti Ronkainen, Stepani Bendel, Jaakko Långsjö, Marika Ala-Peijari, Jani Saunavaara, Riitta Parkkola, Mikko Nyman, Ilkka K. Martikainen, Alex M. Dickens, Juha Rinne, Mika Valtonen, Teijo I. Saari, Timo Koivisto, Paula Bendel, Timo Roine, Antti Saraste, Tero Vahlberg, Juha Tanttari, Timo Laitio

Effect of an intraoperative periradicular application of platelet-rich fibrin (PRF) on residual post-surgical neuropathic pain after disc herniation surgery: study protocol for NeuroPRF, a randomized controlled trial

Julien Todeschi, Guillaume Dannhoff, Andres Hugo Coca, Daniel Ionut Timbolschi, François Proust, François Lefebvre, Vincent Lelievre, Pierrick Poisbeau, Laurent Vallat, Eric Salvat, Yohann Bohren

Rivaroxaban in patients with abdominal aortic aneurysm and high-sensitivity C-reactive protein elevation (BANBOO): study protocol for a randomized, controlled trial

Jingyuan Li, Sicong Ma, Xiu Jia, Yingzhen Bu, Tienan Zhou, Lei Zhang, Miaohan Qiu, Xiaozeng Wang

A single-blind, parallel-group randomised trial of a Technology-assisted and remotely delivered Cognitive Behavioural Therapy intervention (Tech-CBT) versus usual care to reduce anxiety in people with mild cognitive impairment and dementia: study protocol for a randomised trial

Nadeeka Dissanayaka, Deborah Brooks, Peter Worthy, Leander Mitchell, Nancy A. Pachana, Gerard Byrne, Syed Afroz Keramat, Tracy Comans, Sally Bennett, Jacki Liddle, Mark D. Chatfield, Annette Broome, Joanne Oram, Kanaganayagam Appadurai, Elizabeth Beattie, Tiffany Au, Teagan King, Kimberley Welsh, Ann Pietsch

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial

Debbie Tallon, Laura Thomas, Sally Brabyn, Brian Chi Fung Ching, Jane Sungmin Hahn, Berry Jude, Mekeda X Logan, Alex Burrage, Fiona Fox, Simon Gilbody, Paul Lanham, Glyn Lewis, Jinshuo Li, Stephanie J. MacNeill, Irwin Nazareth, Steve Parrott, Tim J. Peters, Roz Shafran, Katrina Turner, Chris Williams, David Kessler, Nicola Wiles

Pregabalin as an effective treatment for acute postoperative pain following spinal surgery without major side effects: protocol for a prospective, randomized controlled, double-blinded trial

Ki-Hoon Park, Nam-Su Chung, Hee-Woong Chung, Tae Young Kim, Han-Dong Lee

  • Open Access
  • Care
  • Research

Evaluating the completeness of the reporting of abstracts since the publication of the CONSORT extension for abstracts: an evaluation of randomized controlled trial in ten nursing journals

Yan He, Rong Zhang, Wenjing Shan, Yuhuan Yin, Xiaoli Zhang, Yiyin Zhang, Xiaoping Wang

Non-COVID-19 UK clinical trials and the COVID-19 pandemic: impact, challenges and possible solutions

Ava Lorenc, Leila Rooshenas, Carmel Conefrey, Julia Wade, Nicola Farrar, Nicola Mills, Sangeetha Paramasivan, Alba Realpe, Marcus Jepson

Effectiveness of laparoscopic removal of isolated superficial peritoneal endometriosis for the management of chronic pelvic pain in women (ESPriT2): protocol for a multi-centre randomised controlled trial

Scott C. Mackenzie, Jacqueline Stephen, Linda Williams, Jane Daniels, John Norrie, Christian M. Becker, Dominic Byrne, Ying Cheong, T. Justin Clark, Kevin G. Cooper, Emma Cox, Ann M. Doust, Priscilla Fernandez, Jeremy Hawe, Tom Holland, Lone Hummelshoj, Louise J. Jackson, Kathleen King, Abha Maheshwari, Dan C. Martin, Lauren Sutherland, Jim Thornton, Katy Vincent, Sanjay Vyas, Andrew W. Horne, Lucy H. R. Whitaker

  • Open Access
  • Methodology

The small trial problem

Jean Raymond, Tim E. Darsaut, Johanna Eneling, Miguel Chagnon

The effectiveness and health-economic evaluation of “Partner in Balance,” a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial

Sander L. Osstyn, Ron Handels, Lizzy M. M. Boots, Sanne C. E. Balvert, Silvia M. A. A. Evers, Marjolein E. de Vugt

  • Open Access
  • Study protocol

Impact of a recognition package as an incentive to strengthen the motivation, performance, and retention of village health teams in Uganda: a study protocol for a cluster randomized controlled trial

Smisha Agarwal, Raymond Tweheyo, Shivani Pandya, Emmanuel Obuya, Arisa Kiyomoto, Paloma Mitra, Meike Schleiff, Tanvi Nagpal, Mario Macis, Elizeus Rutebemberwa

Effect of probiotic supplementation on in-hospital mortality in patients with acute myocardial infarction: a study protocol for an open-label, randomized, controlled, superiority clinical trial

Yequn Chen, Rongbing Chen, Xin Wang, Yan Zhou, Liekai Hong, Nianling Xiong, Jinxiu Zhu, Shu Ye, Xuerui Tan

Photoaging and theory-based intervention to improve sun protection behaviors in students in Zahedan: study protocol for a randomized controlled trial

Hassan Okati-Aliabad, Esmat Sadat Hosseini, Mohammad Ali Morowati Sharifabad, Mahdi Mohammadi, Mohamad Ebrahimzadeh Ardakani, Amir Hossein Talebrouhi

  • Open Access
  • Research

Clinical reasoning in pragmatic trial randomization: a qualitative interview study

Justin T. Clapp, Cassandra Dinh, Monica Hsu, Mark D. Neuman

Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn’s disease (ENDOCIR study): an open-label, multicentre, randomized trial

Carme Loras, Pablo Ruiz-Ramirez, Juan Romero, Xavier Andújar, Josep Bargallo, Esther Bernardos, Marta Maia Boscá-Watts, Carlo Brugiotti, Eduard Brunet, David Busquets, Elena Cerrillo, Francisco Javier Cortina, Juan Antonio Díaz-Milanés, Carmen Dueñas, Ramón Farrés, Thomas Golda, Ferran González-Huix, Joan B. Gornals, Jordi Guardiola, David Julià, Alba Lira, Jordina Llaó, Miriam Mañosa, Ingrid Marin, Mónica Millán, David Monfort, David Moro, Josep Mullerat, Mercè Navarro, Francisco Pérez Roldán, Eva Pijoan, Vicente Pons, José Reyes, María Rufas, Empar Sainz, Vicente Sanchiz, Anna Serracant, Eva Sese, Cristina Soto, Jose Troya, Natividad Zaragoza, Cristian Tebé, Marta Paraira, Emma Sudrià-Lopez, Vicenç Mayor, Fernando Fernández-Bañares, Maria Esteve

Reading intervention for students with intellectual disabilities without functional speech who require augmentative and alternative communication: a multiple single-case design with four randomized baselines

Line Britt Ulriksen, Marthe Bilet-Mossige, Hugo Cogo Moreira, Kenneth Larsen, Anders Nordahl-Hansen

Predictors of participant retention in a community-based HIV prevention cohort: perspectives from the HPTN 071 (PopART) study

Nomtha Bell-Mandla, Ethan Wilson, Deeksha Sharma, Rosa Sloot, Justin Bwalya, Ab Schaap, Deborah Donnell, Estelle Piwowar-Manning, Sian Floyd, Nozizwe Makola, Lungiswa Nkonki, Musonda Simwinga, Ayana Moore, Richard Hayes, Sarah Fidler, Helen Ayles, Peter Bock

SMA-TB: study protocol for the phase 2b randomized double-blind, placebo-controlled trial to estimate the potential efficacy and safety of two repurposed drugs, acetylsalicylic acid and ibuprofen, for use as adjunct therapy added to, and compared with, the standard WHO recommended TB regimen

Lilibeth Arias, Kennedy Otwombe, Ziyaad Waja, Nestani Tukvadze, Tamta Korinteli, Tumelo Moloantoa, Kaori L Fonseca, Natasha Pillay, Thabiso Seiphetlo, Dan Ouchi-Vernet, Adrian Siles, Lidia Carabias, Carles Quiñones, Sergo Vashakidze, Neil Martinson, Cristina Vilaplana

  • Open Access
  • Study protocol

Efficacy of DigiKnowItNews: Teen, a multimedia educational website for adolescents about pediatric clinical trials: study protocol for a randomized controlled trial

Alison E. Parker, Tracy M. Scull, Kathryn L. Kennedy

  • Open Access
  • Methodology

Meta-research on pragmatism of randomized trials: rationale and design of the PragMeta database

Julian Hirt, Perrine Janiaud, Pascal Düblin, Lars G. Hemkens

Advanced practice nurse intervention versus usual care for hypertension control: study protocol for an open-label randomized controlled trial

Juliette Vay-Demouy, Alexandre Cinaud, Nathan Malka, Baptiste Mion, Sandrine Kretz, Hélène Lelong, Jacques Blacher

The CBIT + TMS trial: study protocol for a two-phase randomized controlled trial testing neuromodulation to augment behavior therapy for youth with chronic tics

Christine Conelea, Deanna J. Greene, Jennifer Alexander, Kerry Houlihan, Sarah Hodapp, Brianna Wellen, Sunday Francis, Bryon Mueller, Tim Hendrickson, Angela Tseng, Mo Chen, Mark Fiecas, Kelvin Lim, Alexander Opitz, Suma Jacob

Enhancing educational and vocational recovery in adolescents and young adults with early psychosis through Supported Employment and Education (SEEearly): study protocol for a multicenter randomized controlled trial

D. Jäckel, A. Willert, A. Brose, K. Leopold, D. Nischk, S. Senner, O. Pogarell, S. Sachenbacher, M. Lambert, A. Rohenkohl, P. Kling-Lourenco, N. Rüsch, F. Bermpohl, M. Schouler-Ocak, V. Disselhoff, U. Skorupa, A. Bechdolf

Community-based lifestyle intervention for diabetes (Co-LID study) management in rural Nepal: study protocol for a clustered randomized controlled trial

Lal Rawal, Padam Dahal, Grish Paudel, Tuhin Biswas, Rabina Shrestha, Deepa Makaju, Abha Shrestha, Uday Yadav, Berhe W Sahle, Hanako Iwashita, Gaku Masuda, Andre Renzaho, Prabin Shakya, Archana Shrestha, Biraj Karmacharya, Haruka Sakamoto, Rajendra Koju, Tomohiko Sugishita

The effects of functional foods mixture on inflammatory cytokines and biochemical findings in hospitalized patients with COVID-19: a randomized double-blind controlled trial

Hadi Esmaeili Gouvarchinghaleh, Fateme Kiany, Karim Parastouei, Gholamhosein Alishiri, Nematollah Jonaidi Jafari, Abbas Ali Imani Fooladi, Afsaneh Pargar, Ali Ghazvini, Reza Mirnejad, Mehdi Raei, Ahmadreza Sharifi Olounabadi, Mansour Babaei, Soleyman Heydari, Hosein Rostami, Alireza Shahriary, Gholamreza Farnoosh, Vahid Sobhani, Mohammad Mahdi Mazhari, Farshad NajjarAsiabani

  • Open Access
  • Methodology

Starting a conversation about estimands with public partners involved in clinical trials: a co-developed tool

Suzie Cro, Brennan C Kahan, Akshaykumar Patel, Ania Henley, Joanna C, Paul Hellyer, Manos Kumar, Yasmin Rahman, Beatriz Goulão

Effect of superficial and deep parasternal blocks on recovery after cardiac surgery: study protocol for a randomized controlled trial

Audrey Jeanneteau, Achille Demarquette, Aymeric Blanchard-Daguet, Olivier Fouquet, Sigismond Lasocki, Jérémie Riou, Emmanuel Rineau, Maxime Léger

  • Open Access
  • Review

Informed consent in cancer clinical drug trials in China: a narrative literature review of the past 20 years

Xing Liu, Xiaoran Lu, Wei Zhou, Jessica Hahne, Kaveh Khoshnood, Xiaoting Shi, Yuqiong Zhong, Xiaomin Wang

  • Open Access
  • Anxiety
  • Study protocol

The effect of a parental preparation video (Take5) on child and parent anxiety during anaesthetic induction: a protocol for a randomised controlled trial

Krittika Vongkiatkajorn, Erin A. Brown, Alexandra Donaldson, Vanessa Rich, Rebecca Paterson, Justin Kenardy, Cameron Graydon, Paul Lee-Archer

  • Open Access
  • Heparin
  • Study protocol

Effects of low-dose intravenous heparin therapy in aneurysmal subarachnoid hemorrhage: a randomized controlled clinical trial protocol

Yifan Zhang, Jiangang Hu

Efficacy of mHealth and education-led peer counseling for patients with hypertension and coronary artery disease in Pakistan: study protocol for a double-blinded pragmatic randomized-controlled trial with factorial design

Muhammad Arshed, Rubeena Zakar, Muhammad Farooq Umer, Mehwish Kiran, Najeeb Ullah, Ghazala Iftikhar, Florian Fischer

Randomized double-blind personalized N-of-1 clinical trial to test the safety and potential efficacy of TJ-68 for treating muscle cramps in amyotrophic lateral sclerosis (ALS): study protocol for a TJ-68 trial

Hiroshi Mitsumoto, Ken Cheung, Björn Oskarsson, Howard F. Andrews, Grace E. Jang, Jinsy A. Andrews, Jaimin S. Shah, Joseph Americo Fernandes, Martin McElhiney, Regina M. Santella

A multicentre randomised controlled trial of a guided self-help cognitive behavioural therapy to MANage the impact of hot flushes and night sweats in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2)

Simon Crabb, Alannah Morgan, Myra S. Hunter, Evgenia Stefanopoulou, Gareth Griffiths, Alison Richardson, Deborah Fenlon, Louisa Fleure, James Raftery, Cherish Boxall, Sam Wilding, Jacqueline Nuttall, Zina Eminton, Emma Tilt, Alice O’Neill, Roger Bacon, Jonathan Martin

Necessity of fusion following decompression surgery in patients with single-level lumbar stenosis: study protocol for an open-label multicentre non-inferiority randomized controlled clinical trial

Andrey Grin, Ivan Lvov, Aleksandr Talypov, Vladimir Smirnov, Anton Kordonskiy, Valeriy Lebedev, Andrey Zuev, Ilya Senko, Iren Pogonchenkova, Vladimir Krylov

Correction: ESTIMation of the ABiLity of prophylactic central compartment neck dissection to modify outcomes in low-risk differentiated thyroid cancer: a prospective randomized trial

Dana Hartl, Yann Godbert, Xavier Carrat, Stéphane Bardet, Audrey Lasne-Cardon, Pierre Vera, Elena Ilies, Slimane Zerdoud, Jérôme Sarini, Mohamad Zalzali, Luigi La Manna, Olivier Schneegans, Antony Kelly, Philppe Kaufmann, Patrice Rodien, Laurent Brunaud, Solange Grunenwald, Elie Housseau, Salim Laghouati, Nathalie Bouvet, Elodie Lecerf, Julien Hadoux, Livia Lamartina, Martin Schlumberger, Isabelle Borget

  • Open Access
  • Study protocol

A self-guided Internet-based intervention for individuals with chronic pain and depressive symptoms: study protocol of a randomized controlled trial

Swantje Borsutzky, Steffen Moritz, Birgit Hottenrott, Josefine Gehlenborg

Randomised controlled trials of behavioural nudges delivered through text messages to increase influenza and COVID-19 vaccines among pregnant women (the EPIC study): study protocol

Prabha H. Andraweera, Bing Wang, Margie Danchin, Christopher Blyth, Ivo Vlaev, Jason Ong, Jodie Dodd, Jennifer Couper, Thomas R. Sullivan, Jonathan Karnon, Nicola Spurrier, Michael Cusack, Dylan Mordaunt, Dimi Simatos, Gus Dekker, Samantha Carlson, Jane Tuckerman, Nicholas Wood, Lisa Whop, Helen S. Marshall

  • Open Access
  • Study protocol

Effectiveness of individualized counseling on the duration of exclusive breastfeeding: study protocol for a multicenter, randomized, parallel, and open clinical trial

Mariana Torreglosa Ruiz, Elisa da Conceição Rodrigues, Karine Emanuelle Peixoto Oliveira da Silva, Cynthya Viana de Resende, Michele Curcino Cavalcanti, Luciano Marques dos Santos, Monika Wernet, Ana Letícia Monteiro Gomes, Marialda Moreira Christoffel, Maria Beatriz Guimarães Raponi, Jéssica Aparecida da Silva, Jacqueline Faria de Oliveira, Divanice Contim, Ana Maria Linares

  • Open Access
  • Commentary

Why do older adults decline participation in research? Results from two deprescribing clinical trials

Thomas E. Strayer, Emily K. Hollingsworth, Avantika S. Shah, Eduard E. Vasilevskis, Sandra F. Simmons, Amanda S. Mixon

Individualized lifestyle intervention in PCOS women (IPOS): a study protocol for a multicentric randomized controlled trial for evaluating the effectiveness of an individualized lifestyle intervention in PCOS women who wish to conceive

Neena Malhotra, Taruna Arora, Vanita Suri, Saubhagya Kumar Jena, Asha Verma, Mahasampath Gowri, Nitin Kapoor, Manjeet Singh Chalga, Bharati Kulkarni, Mohan S. Kamath

  • Open Access
  • Research

Clinical research nurse predictions of trial failure, recruitment and retention: a case for their early inclusion in trial design

Frances Shiely, Danielle Murphy, Seán R. Millar

Evaluating the efficacy and safety of acotiamide in patients with esophagogastric junction outflow obstruction: study protocol for an investigator-initiated, multi-center, randomized, double-blind, placebo-controlled phase II trial

Mitsuru Esaki, Eikichi Ihara, Noriaki Manabe, Noriyuki Kawami, Katsuhiko Iwakiri, Junichi Akiyama, Shiko Kuribayashi, Toshio Uraoka, Haruei Ogino, Takatoshi Chinen, Akiko Misumi, Hiroko Watanabe, Maya Suzuki, Junji Kishimoto, Yoshihiro Ogawa

  • Open Access
  • Nitrate
  • Study protocol

A prospective double-blinded randomized study on drug-eluting stent implantation into nitrate-induced maximally dilated vessels in patients with coronary artery disease

Gwang-Seok Yoon, Seong-Huan Choi, Sung Woo Kwon, Sang-Don Park, Seong-Ill Woo

  • Open Access
  • Research

Multi-Round versus Real-Time Delphi survey approach for achieving consensus in the COHESION core outcome set: a randomised trial

Fiona A. Quirke, Malcolm R. Battin, Caitlin Bernard, Linda Biesty, Frank H. Bloomfield, Mandy Daly, Elaine Finucane, David M. Haas, Patricia Healy, Tim Hurley, Sarah Koskei, Shireen Meher, Eleanor J. Molloy, Maira Niaz, Elaine Ní Bhraonáin, Christabell Omukagah Okaronon, Farhana Tabassum, Karen Walker, James R. H. Webbe, Matthew J. Parkes, Jamie J. Kirkham, Declan Devane

Parent coaching via telerehabilitation for young children with autism spectrum disorder (ASD): study protocol for a randomised controlled trial

Isaac Kwee Mien Sia, Ying Qi Kang, Philina LiXuan Lai, Mythra Mahesh, Shang Chee Chong

Protocol for a randomized controlled trial comparing a very low-carbohydrate diet or moderate-carbohydrate plate-method diet for type 2 diabetes: the LEGEND (Lifestyle Education about Nutrition for Diabetes) trial

Laura R. Saslow, Adriana Eslamian, Patricia Moran, Wendy Hartogensis, Ashley E. Mason, Sarah Kim, Douglas C. Bauer, Dina Hafez Griauzde, Veronica Goldman, Vivian Liu, Pam Stephens, Kate Raymond, George Yeung, Cindy Leung, Frederick M. Hecht

Success and complications in lumbar punctures of pediatric patients with leukemia: a study protocol for a randomized clinical crossover trial of a bioimpedance needle system versus conventional procedure

Harri Sievänen, Juho Kari, Henri Aarnivala, Stefan Becker, Anu Huurre, Satu Långström, Sauli Palmu

Optimising DTwP-containing vaccine infant immunisation schedules (OptImms) — a protocol for two parallel, open-label, randomised controlled trials

Sarah Kelly, Xinxue Liu, Katherine Theiss-Nyland, Merryn Voysey, Sarah Murphy, Grace Li, Mary Nyantaro, Meeru Gurung, Sudha Basnet, Bhishma Pokhrel, Sanjeev M. Bijukchhe, Agnes Eordogh, Ben Gombe, Ayoub Kakande, Simon Kerridge, Geofrey Kimbugwe, Sylvia Kusemererwa, Lawrence Lubyayi, Henry Luzze, Olga Mazur, Yama F. Mujadidi, Shamim Nabukenya, Walter-Rodney Nagumo, Tryphena Nareeba, Rabiullah Noristani, Peter O’Reilly, Andrew Roberts, Ganesh Shah, Sonu Shrestha, Laxman P. Shrestha, Surya B. Thapa, Freddie M. Kibengo, Arun K. Sharma, Alison Elliott, Shrijana Shrestha, Andrew J. Pollard

  • Open Access
  • Opioids
  • Study protocol

Pragmatic, randomized, blinded trial to shorten pharmacologic treatment of newborns with neonatal opioid withdrawal syndrome (NOWS)

Adam Czynski, Abbot Laptook, Abhik Das, Brian Smith, Alan Simon, Rachel Greenberg, Robert Annett, Jeannette Lee, Jessica Snowden, Claudia Pedroza, Barry Lester, Barry Eggleston, Drew Bremer, Elisabeth McGowan

Comparison of ultrasound-guided and palpation-inserted peripheral venous cannula in -patients before primary hip or knee arthroplasty: study protocol for a randomized controlled trial

Jakub Hlasny, Roman Alberty, Marian Hlavac, Ivan Grgac, Michael Teodor Grey, Michal Venglarcik

Efficacy of a smartphone application for helping individuals with type 2 diabetes mellitus manage their blood glucose: a protocol for factorial design trial

Hongxia Tang, Hua Qin, Mingjiao Zhang, Jihong Zhang, Huiwen Tan, Mengjie Chen, Laixi Kong, Maoting Guo, Fenghui Hu, Qin Wang, Xiaoxia Wang, Kun Zhang, Zhenzhen Xiong

  • Open Access
  • Update

Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2)

Suzanne Keddie, Ila Fazzio, Siddharudha Shivalli, Nicholas Magill, Diana Elbourne, Dropti Sharma, Sajjan Singh Shekhawat, Rukmini Banerji, Sridevi Karnati, Harshavardhan Reddy, Alex Eble, Peter Boone, Chris Frost

Anal fistulotomy with one-stage shaped skin grafting for intersphincter anal fistulas: study protocol on a multicentre randomised controlled trial

Yongchang Zhao, Wei Xie, Xiaoshuo Wu, Xiaolan Li, Jinyan Guo, Qiurui Cao, Jiadi Liang, Xin-lin Chen, Wentao Zhao, Feng Sun, Hongjie Li, Weimin Luo, Yuying Li

  • Open Access
  • Study protocol

Assisted ambulation to improve health outcomes for older medical inpatients (AMBULATE): study protocol for a randomized controlled trial

Joshua K. Johnson, Aaron C. Hamilton, Bo Hu, Quinn R. Pack, Peter K. Lindenauer, Robert J. Fox, Ardeshir Hashmi, Lee Anne Siegmund, Christian N. Burchill, Glen B. Taksler, Toyomi Goto, Mary Stilphen, Michael B. Rothberg

The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT)

Jorge Piano Simoes, Stefan Schoisswohl, Winfried Schlee, Laura Basso, Alberto Bernal-Robledano, Benjamin Boecking, Rilana Cima, Sam Denys, Milena Engelke, Alba Escalera-Balsera, Alvaro Gallego-Martinez, Silvano Gallus, Dimitris Kikidis, Jose A. López-Escámez, Steven C. Marcrum, Nikolaos Markatos, Juan Martin-Lagos, Marta Martinez-Martinez, Birgit Mazurek, Evgenia Vassou, Carlotta Micaela Jarach, Nicolas Mueller-Locatelli, Patrick Neff, Uli Niemann, Hafez Kader Omar, Clara Puga, Miro Schleicher, Vishnu Unnikrishnan, Patricia Perez-Carpena, Rüdiger Pryss, Paula Robles-Bolivar, Matthias Rose, Martin Schecklmann, Tabea Schiele, Johannes Schobel, Myra Spiliopoulou, Sabine Stark, Carsten Vogel, Nina Wunder, Zoi Zachou, Berthold Langguth

  • Open Access
  • Study protocol

The impact of a blend of Pistacia atlantica seed and canola oil compared with a blend of corn-canola oil with synthetic antioxidant and corn-canola oil without synthetic antioxidant on oxidative stress markers in patients with metabolic syndrome: protocol for a triple-blind, randomized, three-way cross-over clinical trial

Bahareh Sasanfar, Arezoo sadat Emrani, Faezeh Zademohammadi, Bita Forootani, Solaleh Emamgholipour, Sara Jambarsang, Sayyed Saeid Khayyatzadeh, Fatemeh Pourrajab, Seyed Ali Yasini Ardakani, Ahmad Esmaillzadeh, Amin Salehi-Abarghouei

  • Open Access
  • Study protocol

Continuous Positive Airway Pressure plus Mandibular Advancement Therapy (PAPMAT): study protocol for an adaptive randomised crossover trial comparing the benefits and costs of combining two established treatments for obstructive sleep apnoea

Martin Law, Sofia Villar, Nicholas Oscroft, Victoria Stoneman, Julia Fox-Rushby, Yi-Da Chiu, Jo Steele, Thomas Devine, Claire Francis, Thomas Claydon, Graham Hill, Ka Keat Lim, Joanna Rayner, Mandy Williams, Emma Spires, Timothy Quinnell

Pragmatic cluster-randomized trial of home-based preventive treatment for TB in Ethiopia and South Africa (CHIP-TB)

Akash Malhotra, Bareng Aletta Sanny Nonyane, Evan Shirey, Christiaan Mulder, Piotr Hippner, Fiseha Mulatu, Andani Ratshinanga, Petros Mitiku, Silvia Cohn, Gideon Conradie, Violet Chihota, Richard E. Chaisson, Gavin J. Churchyard, Jonathan Golub, David Dowdy, Hojoon Sohn, Salome Charalambous, Ahmed Bedru, Nicole Salazar-Austin

  • Open Access
  • Correction

Correction: Enhancing educational and vocational recovery in adolescents and young adults with early psychosis through Supported Employment and Education (SEEearly): study protocol for a multicenter randomized controlled trial

D. Jäckel, A. Willert, A. Brose, K. Leopold, D. Nischk, S. Senner, O. Pogarell, S. Sachenbacher, M. Lambert, A. Rohenkohl, P. Kling-Lourenco, N. Rüsch, F. Bermpohl, M. Schouler-Ocak, V. Disselhof, U. Skorupa, A. Bechdolf

  • Open Access
  • Research

Pre-notifications increase retention in a 17-year follow-up of adolescents born very preterm

Minttu Helin, Max Karukivi, Päivi Rautava, Milka Hirvonen, Mira Huhtala, Sirkku Setänen, Mikael Ekblad, Satu Ekblad, Eeva Ekholm, Linda Grönroos, Leena Haataja, Laura Haveri, Eveliina Joensuu, Pentti Kero, Riikka Korja, Katri Lahti, Helena Lapinleimu, Liisa Lehtonen, Tuomo Lehtonen, Marika Leppänen, Annika Lind, Jonna Maunu, Petriina Munck, Eeva Mäkilä, Anna Nyman, Riitta Parkkola, Katriina Saarinen, Tiina Saarinen, Susanna Salomäki, Virva Saunavaara, Matti Sillanpää, Suvi Stolt, Karoliina Uusitalo, Milla Ylijoki

Comparing conventional treatment, single-target rTMS, or dual-target rTMS for the treatment of post-stroke cognitive impairment — clinical effects and neuroscientific insights: study protocol for a randomized controlled trial

Bingshan Xu, Chunrong Lin, Cailian Guo, Hong Wang

Correction: OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain—a statistical analysis plan

Caitlin M. P. Jones, Chung-Wei Christine Lin, Richard O. Day, Bart W. Koes, Jane Latimer, Chris G. Maher, Andrew McLachlan, Laurent Billot

Effectiveness of a community health worker-led low-sodium salt intervention to reduce blood pressure in rural Bangladesh: protocol for a cluster randomized controlled trial

Andrew Y. Chang, Mushfiqur Rahman, Animesh Talukder, Humyra Shah, Malay Kanti Mridha, Mehedi Hasan, Malabika Sarker, Pascal Geldsetzer

Analysis of the relationship between EEG burst suppression and poor prognosis in children under general anaesthesia: study protocol for a prospective, observational, single-centre study

Qian Xu, Jianmin Zhang, Zhengzheng Gao, Shanshan Li, Gan Li

  • Open Access
  • Nitrate
  • Study protocol

Efficacy of beetroot juice on reducing blood pressure in hypertensive adults with autosomal dominant polycystic kidney disease (BEET-PKD): study protocol for a double-blind, randomised, placebo-controlled trial

Priyanka S. Sagar, Alexandra Munt, Sayanthooran Saravanabavan, Farnoosh Asghar Vahedi, James Elhindi, Beatrice Nguyen, Katrina Chau, David C. Harris, Vincent Lee, Kamal Sud, Nikki Wong, Gopala K. Rangan

Study protocol for a randomized controlled trial of in-home decluttering augmentation of group cognitive-behavioral therapy for hoarding disorder: the Joining Forces Trial

Sofia Jägholm, Sara Lindstedt, Erik Andersson, David Mataix-Cols, Lorena Fernández de la Cruz, Christian Rück, Volen Z. Ivanov

  • Open Access
  • Study protocol

The effect of the leisure activities based on chess and cards for improving cognition of older adults: study protocol for a cluster randomized controlled trial

Xiaojuan Shi, Yanrong wang, Yueping Wu, Jiangping Li

Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: the REPLENISH randomized clinical trial protocol

Yaseen M. Arabi, Hasan M. Al-Dorzi, Musharaf Sadat, Dina Muharib, Haifa Algethamy, Fahad Al-Hameed, Ahmed Mady, Adnan AlGhamdi, Ghaleb. A. Almekhlafi, Abdulrahman A. Al-Fares, Ayman Kharaba, Ali Al Bshabshe, Khalid Maghrabi, Khalid Al Ghamdi, Ghulam Rasool, Jamal Chalabi, Haifaa Ibrahim AlHumedi, Maram Hasan Sakkijha, Norah Khalid Alamrey, Rabeah Hamad Alhutail, Kaouthar Sifaoui, Mohammed Almaani, Rakan Alqahtani, Ahmad S. Qureshi, Mohammed Moneer Hejazi, Hatim Arishi, Samah AlQahtani, Amro Mohamed Ghazi, Saleh T. Baaziz, Abeer Othman Azhar, Sara Fahad Alabbas, Mohammed AlAqeely, Ohoud AlOrabi, Aliaa Al-Mutawa, Maha AlOtaibi, Omar Aldibaasi, Jesna Jose, Joel Starkopf, Jean-Charles Preiser, Anders Perner, Abdulaziz Al-Dawood, Amal Almatroud, Brintha Naidu, Vicki Burrow, Salha Al Zayer, Haseena Banu Khan, Afonso Varela, Mohamed Ali Alodat, Rayan Alshayeh, AbdulRehman AlHarthi, Naif Al Qahtani, Yasmeen Ayed AlHejiely, Mada Muzhir AlZahrani, Mohammed Haddad Lhmdi, Katrina Baguisa, Huda Mhawisg, Liyakat Khan, Moataz Gabr, Shehla Nuzhat, Madiha ElGhannam, Beverly Bcuizon, Bander AlAnezi, Christine Joy Anaud, Sawsan Albalawi, Manar Alahmadi, Mohammed AlHumaid, Samar Talal Nouri, Rozeena Huma, Khawla Farhan, Samahar Alamoudi, Milyn L. Ansing, Raghad Malabari, Kholoud Shobragi, Shaymaa Asaas, Ahmed Quadri, Khalid Idrees, Arwa AlHusseini, Shahinaz Bashir, Mohamed Hussein, Olfa Baji, Abdulrehman Alerw, Khloud Johani, Monera AlEnezi, Ismail Boudrar, Rabiah Atiq, Maali Junid, Maram Yusef, Mona Bin Mabkoot, Munir AlDammad, Yahia Otaif, Osama Hakami, Mariam Ehab Kenawy, Dalal Ali Alkhamees, Tasneem Abdullah Behbehani

  • Open Access
  • Publisher Correction

Publisher Correction: Individualized lifestyle intervention in PCOS women (IPOS): a study protocol for a multicentric randomized controlled trial for evaluating the effectiveness of an individualized lifestyle intervention in PCOS women who wish to conceive

Neena Malhotra, Taruna Arora, Vanita Suri, Saubhagya Kumar Jena, Asha Verma, Mahasampath Gowri, Nitin Kapoor, Manjeet Singh Chalga, Bharati Kulkarni, Mohan S. Kamath

Correction: A multi-center, open-label, randomized study to explore efficacy and safety of baricitinib in active primary Sjogren’s syndrome patients

Wei Bai, Fan Yang, Huji Xu, Wei Wei, Hongbin Li, Liyun Zhang, Yi Zhao, Xiaofei Shi, Yan Zhang, Xiaofeng Zeng, Xiaomei Leng

  • Open Access
  • Study protocol

Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial

Birgit Coucke, Anaïs Van Hoylandt, Mark Jorissen, Jeroen Meulemans, Thomas Decramer, Johannes van Loon, Vincent Vander Poorten, Tom Theys, Laura Van Gerven

  • Open Access
  • Obesity
  • Study protocol

The effects of sodium butyrate supplementation on the expression levels of PGC-1α, PPARα, and UCP-1 genes, serum level of GLP-1, metabolic parameters, and anthropometric indices in obese individuals on weight loss diet: a study protocol for a triple-blind, randomized, placebo-controlled clinical trial

Parichehr Amiri, Seyed Ahmad Hosseini, Neda Roshanravan, Maryam Saghafi-Asl, Mitra Tootoonchian

Effect of 12-week intermittent calorie restriction compared to standard of care in patients with nonalcoholic fatty liver disease: a randomized controlled trial

Han Ah Lee, Hyeyoung Moon, Yuri Kim, Hye Ah Lee, Hwi Young Kim

Efficacy and safety of pentoxifylline for chronic venous leg ulcers: study protocol for a multicenter randomized controlled trial in China (ESPECT study)

Lihong Chen, Yun Gao, Ming Liu, Qiu Li, Chunmao Han, Yue Zhao, Binghui Li, Jun Xu, Yan Dai, Pei Li, Jianli Li, Yuanyuan Li, Xingwu Ran

An observer-blinded, cluster randomised trial of a typhoid conjugate vaccine in an urban South Indian cohort

Nikhil Sahai, Dilesh Kumar Arunachalam, Tim Morris, Andrew Copas, Prasanna Samuel, Venkata Raghava Mohan, Vinod Abraham, Joshua Anish Selwyn, Praveen Kumar, Winsley Rose, Veeraraghavan Balaji, Gagandeep Kang, Jacob John

Study on self-management of real-time and individualized support in stroke patients based on resilience: a protocol for a randomized controlled trial

N. Jiang, Y. Xv, X. Sun, L. Feng, Y. B. Wang, X. L. Jiang

  • Open Access
  • Research

The detection and management of attempted fraud during an online randomised trial

Thomas A. Willis, Alexandra Wright-Hughes, Clare Skinner, Amanda J. Farrin, Suzanne Hartley, Rebecca Walwyn, Ana Weller, Mohamed Althaf, Stephanie Wilson, Chris P. Gale, Robbie Foy

  • Open Access
  • Commentary

The importance of clinical importance when determining the target difference in sample size calculations

Richard A. Parker, Jonathan A. Cook

Early endovascular intervention for unfavorable remodeling of the thoracic aorta after open surgery for acute DeBakey type I aortic dissection: study protocol for a multicenter, randomized, controlled trial

Yu Liu, Ling Li, Zhenghua Xiao, Liqing Peng, Peng Yang, Chen Lu, Yu Zhang, Haiyue Wang, Jia Hu

  • Open Access
  • Study protocol

Duroplasty for injured cervical spinal cord with uncontrolled swelling: protocol of the DISCUS randomized controlled trial

Samira Saadoun, Lukas Grassner, Maurizio Belci, Jonathan Cook, Ruth Knight, Lucy Davies, Hasan Asif, Ravindran Visagan, Mathew J. Gallagher, Claudius Thomé, Peter J. Hutchinson, Argyro Zoumprouli, Julia Wade, Nicola Farrar, Marios C. Papadopoulos

  • Open Access
  • Study protocol

Efficacy of five-step shoulder manipulation for rotator cuff-related shoulder pain: protocol for a multicenter randomized controlled trial

Shuang Liu, Jin-Tao Liu, Lin Chen, Tian-You Fan, Xue-Jun Cui, Shao-Dan Cheng, Yan-Jiao Chen, Qi Shi, Chun-Chun Xue, Xiao-Feng Li

Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial

Mikko Alanen, Susanna Stjernberg-Salmela, Eero Waris, Teemu Karjalainen, Jouko Miettunen, Jorma Ryhänen, Samuli Aspinen

Impact of simulation-based training in addition to theoretical training versus theoretical training of nurses alone in the occurrence of adverse events related to arteriovenous fistula puncture in chronic hemodialysis patients: study for a cluster randomized controlled trial (SIMFAV2)

Erwan Guillouet, Clémence Tomadesso, Bibiana Acevedo Flores, Patrick Henri, Antoine Lanot, Rémy Morello, Sonia Guillouet

The effect of selenium supplementation on sonographic findings of salivary glands in papillary thyroid cancer (PTC) patients treated with radioactive iodine: study protocol for a double-blind, randomized, placebo-controlled clinical trial

Sepide Amini, Marjan Golshani, Masoud Moslehi, Somayeh Hajiahmadi, Gholamreza Askari, Bijan Iraj, Mohammad Bagherniya

Effects of remote ischemic conditioning on conditioned pain modulation and cardiac autonomic modulation in women with knee osteoarthritis: placebo-controlled randomized clinical trial protocol

Taíse Mendes Biral, Allysiê Priscilla de Souza Cavina, Eduardo Pizzo Junior, Carlos Alberto Toledo Teixeira Filho, Franciele Marques Vanderlei

  • Open Access
  • Study protocol

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 2: study protocol for a hybrid type 2 effectiveness-implementation cluster-randomized trial using train-the-trainer

Catherine A. Callaway, Laurel D. Sarfan, Emma R. Agnew, Lu Dong, Julia M. Spencer, Rafael Esteva Hache, Marlen Diaz, Shayna A. Howlett, Krista R. Fisher, Heather E. Hilmoe Yates, Eric Stice, Amy M. Kilbourne, Daniel J. Buysse, Allison G. Harvey

Do hospitals that participate in COVID-19 research differ from non-trial hospitals? A cross-sectional study of US hospitals

Daniel Kang, Cher X. Huang, Alexander D. Yuen, Keith C. Norris, Tara Vijayan

Can dexamethasone improve postoperative sleep and postoperative delirium in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy? Protocol for a prospective, randomized, double-blind, controlled study

Yaping Shi, Qingyu Sun, Yue Wang, Chunting Chen, Jianfei Jin, Wei Wang, Yuting Lu, Yi Hua, Jianming Liu, Jinjun Bian, Zhou Yi

Is equipoise a useful concept to justify randomised controlled trials in the cultural context of Pakistan? A survey of clinicians in relation to a trial of talking therapy for young people who self-harm

Rakhshi Memon, Muqaddas Asif, Alexandra Pitman, Nasim Chaudhry, Nusrat Husain, Sarah J. L. Edwards

Effect of Tan Tui combined with kinesio taping on the posture control of patients with PFPS: protocol for a randomized controlled trial

Youhua Li, Shuai Tian, Lu Jin, Jixin Li, Xianfa Liu, Jingjing Ji

  • Open Access
  • Anxiety
  • Study protocol

A randomized controlled trial on using predictive algorithm to adapt level of psychological care for community college students: STAND triaging and adapting to level of care study protocol

Alainna Wen, Kate Wolitzky-Taylor, Robert D. Gibbons, Michelle Craske

A comparison of the portfolio low-carbohydrate diet and the ketogenic diet in overweight and obese women with polycystic ovary syndrome: study protocol for a randomized controlled trial

Maryam Sharifi Najafabadi, Jalal Moludi, Yahya Salimi, Amir Saber

A community-based intervention to improve screening, referral and follow-up of non-communicable diseases and anaemia amongst pregnant and postpartum women in rural India: study protocol for a cluster randomised trial

Jane Elizabeth Hirst, Nicole Votruba, Laurent Billot, Varun Arora, Eldho Rajan, Sudhir Raj Thout, David Peiris, Anushka Patel, Robyn Norton, Edward Mullins, Ankita Sharma, Stephen Kennedy, Vivekanand Jha, Devarsetty Praveen

Goals for Adherence with Low-cost Incentives (GOALS): a protocol for a randomized controlled trial evaluating the impact of small airtime incentives on ART adherence among young people living with HIV in Kampala, Uganda

Sebastian Linnemayr, Haijing Crystal Huang, Zachary Wagner, Faith Kemunto Onkundi, Barbara Mukasa, Mary Odiit

  • Open Access
  • Study protocol

Evaluation of interventions to prevent vasovagal reactions among whole blood donors: rationale and design of a large cluster randomised trial

Amy McMahon, Stephen Kaptoge, Matthew Walker, Susan Mehenny, Philippe T Gilchrist, Jennifer Sambrook, Naim Akhtar, Michael Sweeting, Angela M Wood, Kathleen Stirrups, Ryan Chung, Sarah Fahle, Elisha Johnson, Donna Cullen, Rosemary Godfrey, Shannon Duthie, Louise Allen, Paul Harvey, Michael Berkson, Elizabeth Allen, Nicholas A Watkins, John R Bradley, Nathalie Kingston, Gail Miflin, Jane Armitage, David J Roberts, John Danesh, Emanuele Di Angelantonio

Organisational models supported by technology for the management of diabetic disease and its complications in a diabetic clinic setting: study protocol for a randomised controlled trial targeting type 2 diabetes individuals with non-ideal glycaemic values (Telemechron study)

Alexia Giovanazzi, Lorenzo Gios, Marina Mastellaro, Maria Adalgisa Gentilini, Francesca Valent, Sara Condini, Giorgia Bincoletto, Alessandro Bacchiega, Andrea Zorzi, Giulia Malfatti, Francesca Perini, Claudio Eccher, Michele Marchesoni, Marlene Dall’Alda, Massimo Orrasch, Diego Conforti, Sandro Inchiostro

The effects of esketamine and treatment expectation in acute major depressive disorder (Expect): study protocol for a pharmacological fMRI study using a balanced placebo design

Irina Falkenberg, Florian Bitsch, Wei Liu, Alexandros Matsingos, Laila Noor, Christoph Vogelbacher, Cüneyt Yildiz, Tilo Kircher

A multicenter double-blind, placebo-controlled randomized trial to evaluate the safety and efficacy of bovine colostrum in the treatment of severe alcoholic hepatitis (SAH)

S. S. Sidhu, A Dusseja, Shalimar, S Nijhawan, D Kapoor, O Goyal, H Kishore

  • Open Access
  • Care
  • Study protocol

Rotational ThromboElastometry-guided blood component administration versus standard of care in patients with Cirrhosis and coagulopathy undergoing Invasive ProcEdures (RECIPE): study protocol for a randomised controlled trial

Natasha Janko, Ammar Majeed, William Kemp, Chris Hogan, Harshal Nandurkar, Stuart K. Roberts

  • Open Access
  • Study protocol

Potential cognitive and neural benefits of a computerised cognitive training programme based on Structure Learning in healthy adults: study protocol for a randomised controlled trial

Chia-Lun Liu, Xiaoqin Cheng, Boon Linn Choo, Min Hong, Jia Li Teo, Wei Ler Koo, Jia Yuan Janet Tan, Marisha Barth Ubrani, John Suckling, Balázs Gulyás, Victoria Leong, Zoe Kourtzi, Barbara Sahakian, Trevor Robbins, Annabel Shen-Hsing Chen

Prospective, randomized, double-blind, double-dummy, active-controlled, phase 3 clinical trial comparing the safety and efficacy of intranasal dexmedetomidine to oral midazolam as premedication for propofol sedation in pediatric patients undergoing magnetic resonance imaging: the MIDEX MRI trial

Olivia Nzungu Wabelo, Denis Schmartz, Mario Giancursio, Françoise De Pooter, Giulia Caruso, Jean-François Fils, Philippe Van der Linden

Effect of concurrent resistance-aerobic training on inflammatory factors and growth hormones in children with type 1 diabetes: a randomized controlled clinical trial

Marzieh Nazari, Ramin Shabani, Afagh Hassanzadeh-Rad, Mohammad Ali Esfandiari, Setila Dalili

Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial

Nick Birk, Laura L. Oakley, Poppy A. C. Mallinson, Deepa R, Giridhara R. Babu, Moffat Nyirenda, Sanjay Kinra

Efficacy of an Internet-based intervention with self-applied exposure therapy in virtual reality for people with panic disorder: study protocol for a randomized controlled trial

Josephine Schultz, Anna Baumeister, Stella Schmotz, Steffen Moritz, Lena Jelinek

  • Open Access
  • Study protocol

The NightLife study — the clinical and cost-effectiveness of thrice-weekly, extended, in-centre nocturnal haemodialysis versus daytime haemodialysis using a mixed methods approach: study protocol for a randomised controlled trial

Katherine L. Hull, Kate Bramham, Cassandra L. Brookes, Victoria Cluley, Carmel Conefrey, Nicola J. Cooper, Helen Eborall, James Fotheringham, Matthew P. M. Graham-Brown, Laura J. Gray, Patrick B. Mark, Sandip Mitra, Gavin J. Murphy, Niamh Quann, Leila Rooshenas, Madeleine Warren, James O. Burton

  • Open Access
  • Study protocol

The effect of a multi-component behavior change technique intervention on medication adherence among individuals on primary prevention statin therapy: a dose-finding protocol

Mark J. Butler, Anne-Marie N. Romain, Rumisha Augustin, Patrick Robles, Ciaran P. Friel, Thevaa Chandereng, Jerry M. Suls, Elizabeth A. Vrany, Frank Vicari, Ying Kuen Cheung, Karina W. Davidson

A technology-enabled multi-disciplinary team-based care model for the management of Long COVID and other fatiguing illnesses within a federally qualified health center: protocol for a two-arm, single-blind, pragmatic, quality improvement professional cluster randomized controlled trial

Job G. Godino, Jane C. Samaniego, Sydney P. Sharp, Douglas Taren, Alexandra Zuber, Amy J. Armistad, Amanda M. Dezan, Azure J. Leyba, Janna L. Friedly, Aaron E. Bunnell, Eva Matthews, Maureen J. Miller, Elizabeth R. Unger, Jeanne Bertolli, Alison Hinckley, Jin-Mann S. Lin, John D. Scott, Bruce B. Struminger, Christian Ramers

  • Open Access
  • Letter

A response to Al et al. Trials 2023;24:233

Jon F. Merz

  • Open Access
  • Anxiety
  • Study protocol

Testing pathways to scale: study protocol for a three-arm randomized controlled trial of a centralized and a decentralized (“Train the Trainers”) dissemination of a mental health program for Kenyan adolescents

Brenda Ochuku, Tom L. Osborn, Daisy Nerima, Afra van der Markt, Thomas Rusch, Herman Omune, Solace Akello, David M. Ndetei, Katherine E. Venturo-Conerly

  • Open Access
  • Care
  • Study protocol

A pragmatic, open-label, multi-center, randomized controlled clinical trial on the rotational use of interfaces vs standard of care in patients treated with noninvasive positive pressure ventilation for acute hypercapnic respiratory failure: the ROTAtional-USE of interface STUDY (ROTA-USE STUDY)

Rosanna Vaschetto, Cesare Gregoretti, Lorenza Scotti, Nello De Vita, Annalisa Carlucci, Andrea Cortegiani, Claudia Crimi, Alessio Mattei, Raffaele Scala, Eduardo Rocca, Federico Longhini, Gianmaria Cammarota, Giovanni Misseri, Alberto Dal Molin, Sabino Scolletta, Stefano Nava, Salvatore Maurizio Maggiore, Paolo Navalesi

Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial

Victoria Gómez-Dos-Santos, José Antonio López-Plaza, José Manuel Molina-Villar, Luis Blázquez-Hernando, Víctor Diez-Nicolás, Miguel Jiménez-Cidre, Belén Porrero-Guerrero, Rafael Rodríguez-Patrón, Fernando Arias-Fúnez, Alfonso Muriel-García, José María Fernández-Cebrián, Francisco Javier Burgos-Revilla

  • Open Access
  • Correction

Correction: The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS‑C) for serious mental illness in community mental health part 1: study protocol for a hybrid type 2 effectiveness‑implementation cluster‑randomized trial

Laurel D. Sarfan, Emma R. Agnew, Marlen Diaz, Lu Dong, Krista Fisher, Julia M. Spencer, Shayna A. Howlett, Rafael Esteva Hache, Catherine A. Callaway, Amy M. Kilbourne, Daniel J. Buysse, Allison G. Harvey

Correction: End-ischemic hypothermic oxygenated perfusion for extended criteria donors in liver transplantation: a multicenter, randomized controlled trial—HOPExt

Pierre Pradat, Solene Pantel, Marianne Maynard, Laure Lalande, Sylvie Thevenon, Rene Adam, Marc-Antoine Allard, Fabien Robin, Michel Rayar, Emmanuel Boleslawski, Olivier Scatton, Mircea Chirica, François Faitot, Philippe Bachellier, Olivier Soubrane, Kayvan Mohkam, Jean-Yves Mabrut, Mickaël Lesurtel

  • Open Access
  • Study protocol

Gamified family-based health exercise intervention to improve adherence to 24-h movement behaviors recommendations in children: “3, 2, 1 Move on Study”

Alicia M. Alonso-Martínez, Gaizka Legarra-Gorgoñon, Yesenia García-Alonso, Robinson Ramírez-Vélez, Loreto Alonso-Martínez, Blanca Erice-Echegaray, Mikel Izquierdo

Effects of multimodal exercise program on postural balance in patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

Tamires Daros dos Santos, Adriane Schmidt Pasqualoto, Dannuey Machado Cardoso, Ivana Beatrice Mânica Da Cruz, Rafael Noal Moresco, Aron Ferreira da Silveira, Isabella Martins de Albuquerque

  • Open Access
  • Study protocol

Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial

Carolin Steinmetz, Stephanie Heinemann, Ingo Kutschka, Gerd Hasenfuß, Thomas Asendorf, Bjoern Andrew Remppis, Ernst Knoglinger, Clemens Grefe, Johannes Maximilian Albes, Hassina Baraki, Christian Baumbach, Susanne Brunner, Susann Ernst, Wolfgang Harringer, Dirk Heider, Daniela Heidkamp, Christoph Herrmann-Lingen, Eva Hummers, Thomas Kocar, Hans-Helmut König, Simone Krieger, Andreas Liebold, Andreas Martens, Marcus Matzeder, Friedrich Mellert, Christiane Müller, Miriam Puls, Nils Reiss, Martin Schikora, Thomas Schmidt, Martin Vestweber, Monika Sadlonova, Christine A. F. von Arnim, Michael Denkinger, Oliver Dewald, Michael Don, Julia Frankenhauser-Manuß, Christine Kleber-Peukert, Anna-Maria Kloidt, Tim Matthes, Annemieke Munderloh, Elisabeth Schieffer

Continuous passive paracentesis versus large-volume paracentesis in the prevention and treatment of intra-abdominal hypertension in the critically ill cirrhotic patient with ascites (COPPTRIAHL): study protocol for a randomized controlled trial

Rui Antunes Pereira, Daniel Virella, Rui Perdigoto, Paulo Marcelino, Faouzi Saliba, Nuno Germano

The effect of a customised digital adherence tool on HIV treatment outcomes in young people living with HIV (YPLHIV) in Blantyre, Malawi: a protocol for a randomised controlled trial

Takondwa Charles Msosa, Iraseni Swai, Marion Sumari-de Boer, Kennedy Ngowi, Tobias F. Rinke de Wit, Rob Aarnoutse, Marriott Nliwasa

  • Open Access
  • Study protocol

Volume-targeted ventilation vs pressure-controlled ventilation for very low birthweight infants: a protocol of a randomized controlled trial

Jun Tang, Lingyue Gong, Tao Xiong, Chao Chen, Ke Tian, Aoyu Wang, Yi Huang, Wenli Liu, Rong Zhou, Jun Zhu, Dezhi Mu

  • Open Access
  • Commentary

What is the role of randomised trials in implementation science?

Robbie Foy, Noah M. Ivers, Jeremy M. Grimshaw, Paul M. Wilson

  • Open Access
  • Opioids
  • Study protocol

Sickle Cell Disease Treatment with Arginine Therapy (STArT): study protocol for a phase 3 randomized controlled trial

Chris A. Rees, David C. Brousseau, Daniel M. Cohen, Anthony Villella, Carlton Dampier, Kathleen Brown, Andrew Campbell, Corrie E. Chumpitazi, Gladstone Airewele, Todd Chang, Christopher Denton, Angela Ellison, Alexis Thompson, Fahd Ahmad, Nitya Bakshi, Keli D. Coleman, Sara Leibovich, Deborah Leake, Dunia Hatabah, Hagar Wilkinson, Michelle Robinson, T. Charles Casper, Elliott Vichinsky, Claudia R. Morris

Statistical analysis plan for a randomized controlled trial examining pedometer-based walking intervention in patients with heart failure with reduced ejection fraction: the WATCHFUL trial

Tomas Vetrovsky, Michal Siranec, Tereza Frybova, Iulian Gant, Miroslav Semerad, Marie Miklikova, Vaclav Bunc, Jiri Vesely, Jiri Stastny, Martin Griva, Jan Precek, Radek Pelouch, Jiri Parenica, Jiri Jarkovsky, Jan Belohlavek

The role of the communicated treatment rationale on treatment outcome: study protocol for a randomized controlled trial

Liv Henrich, Marcel Wilhelm, Philipp Lange, Winfried Rief

Radical antegrade modular pancreatosplenectomy (RAMPS) versus standard retrograde pancreatosplenectomy (SRPS) for resectable body and tail pancreatic adenocarcinoma: protocol of a multicenter, prospective, randomized phase III control trial (CSPAC-3)

Jialin Li, Si Shi, Jiang Liu, Chen Liang, Jie Hua, Qingcai Meng, Hang Xu, Miaoyan Wei, Bo Zhang, Jin Xu, Wei Wang, Xianjun Yu

A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial

Xin Wu, Hailin Yu, Yongrui Bai, Yanli Hou, Weihua Lou, Xipeng Wang, Tao Zhu, Yuyang Zhang, Weiguo Hu, Xiaohong Xue, Zhiling Zhu, Libing Xiang, Jiarui Li, Xuhong Fang, Shujun Gao, Hua Feng, Wenjing Diao, Hongwei Zhang, Ming Du, Weili Yan, Ling Qiu, Hao Feng, Shurong Zhu, Yan Du, Hua Jiang

  • Open Access
  • Research

Rating versus ranking in a Delphi survey: a randomized controlled trial

Claudio Del Grande, Janusz Kaczorowski

MyKid’sNutrition mobile application trial: a randomized controlled trial to promote mothers’ nutritional knowledge and nutritional status of preschool children with undernutrition—a study protocol

Ali Hojati, Sogol Alesaeidi, Saeideh Izadi, Alireza Nikniaz, Mahdieh Abbasalizad Farhangi

Clinical trial protocol for P-NeLoP: a randomized controlled trial comparing the feasibility and outcomes of robot-assisted partial nephrectomy with low insufflation pressure using AirSeal versus standard insufflation pressure (UroCCR no. 85 study)

Gaelle Margue, Pierre Bigot, Alexandre Ingels, Morgan Roupret, Thibaut Waeckel, Jean-Alexandre Long, Géraldine Pignot, Karim Bensalah, Hervé Lang, Jonathan Olivier, Franck Bruyere, Matthieu Durand, Jean-Baptiste Beauval, Richard Mallet, Bastien Parier, Alexandre De La Taille, Jean-Christophe Bernhard

Effect of postoperative application of esketamine on postoperative depression and postoperative analgesia in patients undergoing pancreatoduodenectomy: a randomized controlled trial protocol

Kaili Yu, Zhenguo Song, Bowen Zhang, Qian Pan, Shan Gan, Shaoyong Yang, Quanyong Yang, Xinhua Zuo, Yiqing Yin

  • Open Access
  • Study protocol

Effects of a remotely supervised physical training program combined with cognitive training for older individuals at increased risk of clinical-functional vulnerability: study protocol for a randomized clinical trial

Franciele Costa Berní, Ana Carolina Kanitz, Camila Miranda, Dener Budziarek de Oliveira, Marco Bergamin, Valentina Bullo, Gustavo Zaccaria Schaun, Cristine Lima Alberton

  • Open Access
  • Study protocol

The Growth Hormone Deficiency (GHD) Reversal Trial: effect on final height of discontinuation versus continuation of growth hormone treatment in pubertal children with isolated GHD—a non-inferiority Randomised Controlled Trial (RCT)

Elizabeth Brettell, Wolfgang Högler, Rebecca Woolley, Carole Cummins, Jonathan Mathers, Raymond Oppong, Laura Roy, Adam Khan, Charmaine Hunt, Mehul Dattani, Ken Ong, Malcolm Donaldson, Victoria Harris, Mohamad Maghnie, John Gregory, Peter Auguste, Gerhard Binder, Carrol Gambol, Poonam Dhamaraj, Evelien Gevers, Vrinda Saraff, Peter Clayton, Tabitha Randell, Talat Mushtaq, Timothy Cheetham, Justin Davies, Noina Abid, Ranna El Khairi, Klaus Kapelari, Elena Gottardi-Butturini, Elke Reiterer-Fröhlich, Walter Bonfig

Complex physical therapy employing self-adjusting garment (ReadyWrap®) in breast cancer-related lymphedema cases in Brazilian women: a protocol for a randomized controlled trial

Jéssica Malena Pedro da Silva, Raul Denner Duarte Araújo, Francisca Cristina da Silva Santos, Erica Alves Nogueira Fabro, Marcus Vinicius de Mello Pinto, Suzana Sales de Aguiar, Luiz Claudio Santos Thuler, Anke Bergmann

  • Open Access
  • Care
  • Study protocol

Community-based integrated care for patients with diabetes and depression (CIC-PDD): study protocol for a cluster randomized controlled trial

Yanshang Wang, Dan Guo, Ming Wang, Mingzheng Hu, Dawei Zhu, Qianqian Yu, Zhansheng Li, Xiaoyi Zhang, Ruoxi Ding, Miaomiao Zhao, Ping He

A randomized control trial to support smoke-free policy compliance in public housing

Diana Hernandez, Farzana Khan, David Albert, Daniel Giovenco, Charles Branas, Linda Valeri, Ana Navas-Acien

Protocol of a multicenter, single-blind, randomized, parallel controlled trial evaluating the effect of microbiological rapid on-site evaluation (M-ROSE) guiding anti-infection treatment in patients with severe hospital-acquired pneumonia

Xiuli Wang, Kaifei Wang, Fei Xie, Zhihai Han, Yuhong Liu, Lei Pan, Guangfa Zhu, Zhixin Cao, Peng Yan, Li Xiao, Zhimei Duan, Ye Hu, Kun Xiao, Xuxin Chen, Han Fu, Yinghan Shi, Yuwei Song, Xiaobo Han, Wuxiang Xie, Lixin Xie

Study protocol: effects of treatment expectation toward repetitive transcranial magnetic stimulation (rTMS) in major depressive disorder—a randomized controlled clinical trial

Katharina M. Steiner, Dagmar Timmann, Ulrike Bingel, Angelika Kunkel, Tamas Spisak, Manfred Schedlowski, Sven Benson, Harald Engler, Norbert Scherbaum, Katja Koelkebeck

Safety and efficacy of camrelizumab combined with radiotherapy as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma: a prospective single-arm phase II clinical trial protocol

Maohui Chen, Yizhou Huang, Shuliang Zhang, Taidui Zeng, Guanglei Huang, Chun Chen, Bin Zheng

Technology-assisted cognitive-behavior therapy delivered by peers versus standard cognitive behavior therapy delivered by community health workers for perinatal depression: study protocol of a cluster randomized controlled non-inferiority trial

Atif Rahman, Abid Malik, Najia Atif, Huma Nazir, Ahmed Zaidi, Anum Nisar, Ahmed Waqas, Maria Sharif, Tao Chen, Duolao Wang, Siham Sikander

  • Open Access
  • Methodology

The Smooth Away From Expected (SAFE) non-inferiority frontier: theory and implementation with an application to the D3 trial

Matteo Quartagno, Man Chan, Anna Turkova, Deborah Ford, Ian R. White

Effectiveness of group arts therapies (art therapy, dance movement therapy and music therapy) compared to group counselling for diagnostically heterogeneous psychiatric community patients: study protocol for a randomised controlled trial in mental health services (the ERA study)

Catherine E. Carr, Emma Medlicott, Richard Hooper, Yan Feng, Borislava Mihaylova, Stefan Priebe

  • Open Access
  • Care
  • Study protocol

The effects of therapeutic virtual reality experience to promote mental well-being in older people living with physical disabilities in long-term care facilities

Rick Yiu Cho Kwan, Fowie Ng, Linda Chiu Wa Lam, Rebecca Choy Yung, Olive Shuk Kan Sin, Sally Chan

The With Or Without Olecranon K-wire (WOW OK) Trial of tension band wire fixation versus cerclage fixation without K-wires in displaced stable olecranon fractures: study protocol for a randomized controlled trial

Gustav Cornefjord, Ioannis Kostogiannis, Cecilia Rogmark, Daniel Jerrhag, Daniel Wenger

Effect of preoperative coronary CT for planning of percutaneous coronary intervention for complex chronic total occlusion (CTS-C-CTOPCI): study protocol for an open-label randomised controlled trial

Eugenio La Scala, Jean-Pascal Peyre, Eric Maupas, Jacobus H. Muller, Mo Saffarini, Alfredo Galassi, Giuseppe Vadalà, Luca Grancini, Daniele Andreini, Antoine Boge, Jerome Brunet

Proton pump inhibitors in critically ill mechanically ventilated patients with COVID-19: protocol for a substudy of the Re-EValuating the Inhibition of Stress Erosions (REVISE) Trial

Brittany B. Dennis, Lehana Thabane, Diane Heels-Ansdell, Joanna C. Dionne, Alexandra Binnie, Jennifer Tsang, Gordon Guyatt, Aijaz Ahmed, François Lauzier, Adam Deane, Yaseen Arabi, John Marshall, Nicole Zytaruk, Lois Saunders, Simon Finfer, John Myburgh, John Muscedere, Shane English, Marlies Ostermann, Miranda Hardie, Serena Knowles, Deborah Cook

  • Open Access
  • Methodology

Evaluation of randomized controlled trials: a primer and tutorial for mental health researchers

Mathias Harrer, Pim Cuijpers, Lea K. J. Schuurmans, Tim Kaiser, Claudia Buntrock, Annemieke van Straten, David Ebert

  • Open Access
  • Laser
  • Study protocol

Effect of high-intensity laser therapy in patients with non-specific chronic neck pain: study protocol for a randomized controlled trial

Hernán Andrés de la Barra Ortiz, Mariana Arias Avila, Luis Gómez Miranda, Richard Eloin Liebano

Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trial and preliminary baseline data

Kristen Lantis, Patrick Schnell, Courtney R. Bland, Jacqueline Wilder, Karen Hock, Craig Vargo, Nelson A. Glover, Madeleine E. Hackney, Maryam B. Lustberg, Lise Worthen-Chaudhari

  • Open Access
  • Commentary

Time for a proper career pathway for clinical trial managers?

E. J. Mitchell, E. Campbell, K. Goodman, J. Taylor, N. F. J. Youssouf, N. Wakefield, Claire Cochran, Sarah Cockayne, Riti Desai, Lucy Fletcher, Sarah A. Lawton, Ryonfa Lee, Kat Oatey, Joshua Savage

  • Open Access
  • Commentary

Optimizing data integration in trials that use EHR data: lessons learned from a multi-center randomized clinical trial

Sudha R. Raman, Laura G. Qualls, Bradley G. Hammill, Adam J. Nelson, Ester Kim Nilles, Keith Marsolo, Emily C. O’Brien

  • Open Access
  • Study protocol

Effectiveness and safety of mesenchymal stem/stromal cell for radiation-induced hyposalivation and xerostomia in previous head and neck cancer patients (MESRIX-III): a study protocol for a single-centre, double-blinded, randomised, placebo-controlled, phase II study

Kathrine Kronberg Jakobsen, Amanda-Louise Fenger Carlander, Christian Grønhøj, Tobias Todsen, Jacob Melchiors, Natasja Paaske, Anne Kathrine Østergaard Madsen, Jens Kastrup, Annette Ekblond, Mandana Haack-Sørensen, Mohammad Farhadi, Christian Maare, Jeppe Friborg, Charlotte Duch Lynggard, Christian von Buchwald

Pivmecillinam with Amoxicillin/Clavulanic acid as step down oral therapy in febrile Urinary Tract Infections caused by ESBL-producing Enterobacterales (PACUTI)

Jonas Tverring, Emeli Månsson, Vigith Andrews, Oskar Ljungquist

The effect of perioperative of dexamethasone on postoperative complications after pancreaticoduodenectomy (PANDEX): a study protocol for a pragmatic multicenter randomized controlled trial

Haoda Chen, Ying Wang, Chao Wang, Xiaojian Lu, Yilong Li, Bei Sun, Kuirong Jiang, Yudong Qiu, Rufu Chen, Liping Cao, Shi Chen, Yan Luo, Baiyong Shen

The impact of PECS II blockade in patients undergoing minimally invasive cardiac surgery—a prospective, randomized, controlled, and triple-blinded trial

Elisabeth Hoerner, Ottokar Stundner, Felix Naegele, Anna Fiala, Nikolaos Bonaros, Peter Mair, Johannes Holfeld, Lukas Gasteiger

Comparison of three regimens with inhalational methoxyflurane versus intranasal fentanyl versus intravenous morphine in pre-hospital acute pain management: study protocol for a randomized controlled trial (PreMeFen)

Randi Simensen, Lars Olav Fjose, Marius Rehn, Jostein Hagemo, Kjetil Thorsen, Fridtjof Heyerdahl

MEsh FIxation in Laparoendsocopic Repair of Large M3 inguinal hernias: multicenter, double-blinded, randomized controlled trial—study protocol for a MEFI Trial

Mateusz Zamkowski, Maciej Śmietański

The effect of patient-led goal setting approach combined with pain neuroscience education or manual therapy in patients with chronic low back pain: protocol for a parallel-group randomized controlled trial

Sahar Soheili, Amir Letafatkar, Mahdi Hosseinzadeh

Motivations for paediatric vaccine trial participation

Kushalinii Hillson, Jonathan Kantor, Marta Valente Pinto, Andrew J. Pollard, Dominic Kelly, Samantha Vanderslott

PHaLIR: prevent hernia after loop ileostomy reversal—a study protocol for a randomized controlled multicenter study

Karolina Eklöv, Sven Bringman, Jenny Löfgren, Jonas Nygren, Åsa H. Everhov

Protocol for a randomized controlled trial of endoscopic ultrasound guided celiac plexus neurolysis (EUS-CPN) with vs without bupivacaine

Eslam Esmail, Sarto C Paquin, Anand V Sahai

Concordance of a decision algorithm and multidisciplinary team meetings for patients with liver cancer—a study protocol for a randomized controlled trial

Sharlyn S. T. Ng, Robert Oehring, Nikitha Ramasetti, Roland Roller, Philippe Thomas, Yuxuan Chen, Simon Moosburner, Axel Winter, Max-Magnus Maurer, Timo A. Auer, Can Kamali, Johann Pratschke, Christian Benzing, Felix Krenzien

A small clinical trial of vaporized cannabis for PTSD: suggestive results and directions for future study

Zach Walsh, Ian Mitchell, Kim Crosby, Michelle St. Pierre, Drew DeClerck, Kaye Ong, Philippe Lucas

  • Open Access
  • Letter

The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023

Richard A. Parker

Precise management system for chronic intractable pain patients implanted with spinal cord stimulation based on a remote programming platform: study protocol for a randomized controlled trial (PreMaSy study)

Yuanchen Cheng, Duo Xie, Yan Han, Siying Guo, Zhenxing Sun, Linkai Jing, Weitao Man, Dongkang Liu, Kaiyuan Yang, Dan Lei, Zhe Meng, Huifang Zhang, Guoqin Wang, Weiwei Wu, Guihuai Wang, Yang Lu

Effect of the clinical decision assessment system on clinical outcomes of delirium in hospitalized older adults: study protocol for a pair-matched, parallel, cluster randomized controlled superiority trial

Jiamin Wang, Sen Niu, Ying Wu

Effect of integrating traditional care with modern healthcare to improve tuberculosis control programs in Ethiopia: a protocol for a cluster-randomized controlled trial

Desalegne Amare, Fentie Ambaw, Kefyalew Addis Alene

  • Open Access
  • Study protocol

The effect of smartphone-based monitoring and treatment including clinical feedback versus smartphone-based monitoring without clinical feedback in bipolar disorder: the SmartBipolar trial—a study protocol for a randomized controlled parallel-group trial

Maria Faurholt-Jepsen, Natacha Blauenfeldt Kyster, Malene Schwarz Dyreholt, Ellen Margrethe Christensen, Pernille Bondo-Kozuch, Anna Skovgaard Lerche, Birte Smidt, Ulla Knorr, Kim Brøndmark, Anne-Marie Bangsgaard Cardoso, Anja Mathiesen, Rene Sjælland, Henrik Nørbak-Emig, Lotte Linnemann Sponsor, Darius Mardosas, Ida Palmblad Sarauw-Nielsen, Jens Drachmann Bukh, Trine Vøgg Heller, Mads Frost, Nanna Iversen, Jakob Eyvind Bardram, Jonas Busk, Maj Vinberg, Lars Vedel Kessing

A treatment strategy with nifedipine versus labetalol for women with pregnancy hypertension: study protocol for a randomised controlled trial (Giant PANDA)

Danielle Ashworth, Cheryl Battersby, Debra Bick, Marcus Green, Pollyanna Hardy, Lisa Leighton, Laura A. Magee, Alisha Maher, Richard J. McManus, Catherine Moakes, R. Katie Morris, Catherine Nelson-Piercy, Jenie Sparkes, Oliver Rivero-Arias, Andrew Webb, Hannah Wilson, Jenny Myers, Lucy C. Chappell

  • Open Access
  • CABG
  • Study protocol

Glycaemic control using mobile-based intervention in patients with diabetes undergoing coronary artery bypass—study protocol for a randomized controlled trial

Yangwu Song, Yifeng Nan, Wei Feng

Managing non-acute subdural hematoma using liquid materials: a Chinese randomized trial of middle meningeal artery treatment (MAGIC-MT)—protocol

Qiao Zuo, Wei Ni, Pengfei Yang, Yuxiang Gu, Ying Yu, Heng Yang, Charles B. L. M. Majoie, Mayank Goyal, Jianmin Liu, Ying Mao

Protocol of the process evaluation of cluster randomised control trial for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FluCare)

Linda Birt, Thando Katangwe-Chigamba, Sion Scott, David J Wright, Adam P. Wagner, Erika Sims, Veronica Bion, Carys Seeley, Faisal Alsaif, Allan Clarke, Alys Griffiths, Liz Jones, Alison Bryant, Amrish Patel

  • Open Access
  • Study protocol

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3)

Mark Hayward, Katherine Berry, Stephen Bremner, Kate Cavanagh, Guy Dodgson, David Fowler, Heather Gage, Kathryn Greenwood, Cassie Hazell, Anna-Marie Bibby-Jones, Sam Robertson, Morro Touray, Natalie Dailey, Clara Strauss

SPIOMET4HEALTH—efficacy, tolerability and safety of lifestyle intervention plus a fixed dose combination of spironolactone, pioglitazone and metformin (SPIOMET) for adolescent girls and young women with polycystic ovary syndrome: study protocol for a multicentre, randomised, double-blind, placebo-controlled, four-arm, parallel-group, phase II clinical trial

Cristina Garcia-Beltran, Rita Malpique, Marianne S. Andersen, Firdevs Bas, Judit Bassols, Feyza Darendeliler, Marta Díaz, Barbara Dieris, Flaminia Fanelli, Elke Fröhlich-Reiterer, Alessandra Gambineri, Dorte Glintborg, Abel López-Bermejo, Christopher Mann, Silvia Marin, Barbara Obermayer-Pietsch, Rønnaug Ødegård, Pernille Ravn, Thomas Reinehr, Matteo Renzulli, Cristina Salvador, Viola Singer, Eszter Vanky, Juan Vicente Torres, Melek Yildiz, Francis de Zegher, Lourdes Ibáñez

  • Open Access
  • Care
  • Study protocol

CRADLE-5: a stepped-wedge type 2 hybrid implementation-effectiveness cluster randomised controlled trial to evaluate the real-world scale-up of the CRADLE Vital Signs Alert intervention into routine maternity care in Sierra Leone—study protocol

Alexandra E. Ridout, Francis L. Moses, Simren Herm-Singh, Cristina Fernandez Turienzo, Paul T. Seed, Venetia Goodhart, Nicola Vousden, Betty Sam, Mariama Momoh, Daniel Kamara, Katy Kuhrt, Sorie Samura, Candace Beoku-Betts, Alice Hurrell, Kate Bramham, Sartie Kenneh, Francis Smart, Lucy Chappell, Jane Sandall, Andrew Shennan

Q-HAM: a multicenter upfront randomized phase II trial of quizartinib and high-dose Ara-C plus mitoxantrone in relapsed/refractory AML with FLT3-ITD

Sonia Jaramillo, Lucian Le Cornet, Markus Kratzmann, Johannes Krisam, Martin Görner, Mathias Hänel, Christoph Röllig, Maxi Wass, Sebastian Scholl, Mark Ringhoffer, Alexander Reichart, Björn Steffen, Sabine Kayser, Jan-Henrik Mikesch, Kerstin Schaefer-Eckart, Jörg Schubert, Thomas Geer, Sonja Martin, Meinhard Kieser, Tim Sauer, Katharina Kriegsmann, Michael Hundemer, Hubert Serve, Martin Bornhäuser, Carsten Müller-Tidow, Richard F. Schlenk

  • Open Access
  • Study protocol

A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention “mStress-IHD” trial

Julia Lortz, Tienush Rassaf, Christoph Jansen, Ramtin Knuschke, Adam Schweda, Lenka Schnaubert, Christos Rammos, Juliane Köberlein-Neu, Eva-Maria Skoda, Martin Teufel, Alexander Bäuerle

  • Open Access
  • Nitrate
  • Study protocol

A double-blind, randomised, placebo-controlled parallel study to investigate the effect of sex and dietary nitrate on COVID-19 vaccine-induced vascular dysfunction in healthy men and women: protocol of the DiNOVasc-COVID-19 study

Asad Shabbir, Ismita Chhetri, Rayomand S. Khambata, Tipparat Parakaw, Clement Lau, Muhammad A. B. N. Aubdool, Gianmichele Massimo, Nicki Dyson, Vikas Kapil, Thomas Godec, Vanessa Apea, Jan Flint, Chloe Orkin, Krishnaraj S. Rathod, Amrita Ahluwalia

Prospective randomized study on the efficacy of three-dimensional reconstructions of bronchovascular structures on preoperative chest CT scan in patients who are candidates for pulmonary segmentectomy surgery: the PATCHES (Prospective rAndomized sTudy efficaCy of tHree-dimensional rEconstructions Segmentecomy) study protocol

Francesco Zaraca, Andreas Kirschbaum, Marco Damiano Pipitone, Luca Bertolaccini, Firas Abu Akar, Giorgio Cannone, Mahmoud Ismail, Marcelo Jiménez, Marko Kostic, Calvin S.H. Ng, Reinhold Perkmann, Elena Priscindaro, Lorenzo Spaggiari, Paula Ugalde

Reducing antimicrobial overuse through targeted therapy for patients with community-acquired pneumonia: a study protocol for a cluster-randomized factorial controlled trial (CARE-CAP)

Abhishek Deshpande, Ramara Walker, Rebecca Schulte, Andrea M. Pallotta, Larisa G. Tereshchenko, Bo Hu, Sameer S. Kadri, Michael Klompas, Michael B. Rothberg

The anesthetic efficacy of ultrasound-guided lumbar plexus combined with quadratus lumborum block with Shamrock approach in total hip arthroplasty: study protocol for a randomized controlled trial

Xiaofeng Wang, Hui Zhang, Yongzhu Chen, Zhenwei Xie, Moxi Chen, Yonglin Chen, Junfeng Zhang

Protocol for a randomized control trial of the Building Regulation in Dual Generations Program (BRIDGE): preventing the intergenerational transmission of mental illness in at-risk preschool children

Lara Penner-Goeke, Madeline Belows, Amanda Kristjanson, Brendan F. Andrade, Emily E. Cameron, Ryan Giuliano, Laurence Y. Katz, Lauren E. Kelly, Nicole Letourneau, Natalie Mota, Kristin Reynolds, Maureen Zalewski, Ashley Pharazyn, Leslie E. Roos

  • Open Access
  • Correction

Correction: Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments

Caroline Cake, Emma Ogburn, Heather Pinches, Garry Coleman, David Seymour, Fran Woodard, Sinduja Manohar, Marjia Monsur, Martin Landray, Gaynor Dalton, Andrew D. Morris, Patrick F. Chinnery, F. D. Richard Hobbs, Christopher Butler

Comparison of video laryngoscope, video stylet, and flexible videoscope for transoral endotracheal intubation in patients with difficult airways: a randomized, parallel-group study

Tao Zhang, Kai-Yuan Zhao, Ping Zhang, Ren-Hu Li

Effectiveness of neuromuscular electrical stimulation in severe acute pancreatitis complicated patients with acute respiratory distress syndrome: study protocol for a randomized controlled trial

Feng Zhou, Dingrong Fan, Yan Feng, Cuijuan Zhou, Xiaodong Chen, Xiaoyun Ran, Botao Tan

Protocol for a single-blind randomized clinical trial to test the efficacy of bilateral transcranial magnetic stimulation on upper extremity motor function in patients recovering from stroke

Yuan Huang, Ruizhu Lin, Hongyu Li, Yujuan Xu, Fubao Tian, Liangchen Ma, Xiaoli Liu, Shuming Ma, Xiaolong Li, Zheying Lai, Chuanping Bai, Weichun He, Qi Ma, Jingkai Wang, Ning Zhu

New ways to cope with depression—study protocol for a randomized controlled mixed methods trial of bouldering psychotherapy (BPT) and mental model therapy (MMT)

Leona Kind, Katharina Luttenberger, Vivien Leßmann, Lisa Dorscht, Christiane Mühle, Christian P. Müller, Eva-Maria Siegmann, Sophia Schneider, Johannes Kornhuber

  • Open Access
  • Study protocol

Prospective identification of variables as outcomes for treatment (PIVOT): study protocol for a randomised, placebo-controlled trial of hydroxyurea for Ghanaian children and adults with haemoglobin SC disease

Luke R. Smart, Catherine I. Segbefia, Teresa S. Latham, Susan E. Stuber, Kwesi N. Amissah-Arthur, Klenam Dzefi-Tettey, Adam C. Lane, Yvonne A. Dei-Adomakoh, Russell E. Ware

Efficacy of the latest new stimulation patterns of spinal cord stimulation for intractable neuropathic pain compared to conventional stimulation: study protocol for a clinical trial

Takafumi Tanei, Satoshi Maesawa, Yusuke Nishimura, Yoshitaka Nagashima, Tomotaka Ishizaki, Masahiko Ando, Yachiyo Kuwatsuka, Atsushi Hashizume, Shimon Kurasawa, Ryuta Saito

A monocenter, patient-blinded, randomized, parallel-group, non-inferiority study to compare cochlear implant receiver/stimulator device fixation techniques (COMFIT) with and without drilling in adults eligible for primary cochlear implantation

Laura M. Markodimitraki, Timen C. ten Harkel, Edwin Bennink, Inge Stegeman, Hans G. X. M. Thomeer

Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial

M. Toles, C. Kistler, F. C. Lin, M. Lynch, K. Wessell, S. L. Mitchell, L. C. Hanson

Effect of dexmedetomidine on postoperative delirium in patients undergoing awake craniotomies: study protocol of a randomized controlled trial

Muhan Li, Minying Liu, Qianyu Cui, Min Zeng, Shu Li, Liyong Zhang, Yuming Peng

Endoscopic ultrasonography-guided gastroenterostomy versus surgical gastrojejunostomy for palliation of malignant gastric outlet obstruction (ENDURO): study protocol for a randomized controlled trial

Janine B. Kastelijn, Yorick L. van de Pavert, Marc G. Besselink, Paul Fockens, Rogier P. Voermans, Roy L. J. van Wanrooij, Thomas R. de Wijkerslooth, Wouter L. Curvers, Ignace H. J. T. de Hingh, Marco J. Bruno, Bas Groot Koerkamp, Gijs A. Patijn, Alexander C. Poen, Jeanin E. van Hooft, Akin Inderson, J. Sven D. Mieog, Jan-Werner Poley, Alderina Bijlsma, Daan J. Lips, Niels G. Venneman, Robert C. Verdonk, Hendrik M. van Dullemen, Frederik J. H. Hoogwater, Geert W. J. Frederix, I. Quintus Molenaar, Paco M. J. Welsing, Leon M. G. Moons, Hjalmar C. van Santvoort, Frank P. Vleggaar

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs

Jemima A. Frimpong, Carrigan L. Parish, Daniel J. Feaster, Lauren K. Gooden, Mindy C. Nelson, Tim Matheson, Karolynn Siegel, Louise Haynes, Benjamin P. Linas, Sabrina A. Assoumou, Susan Tross, Tiffany Kyle, Terri K. Liguori, Oliene Toussaint, Debra Annane, Lisa R. Metsch

A comparison of the effects of occupation-based interventions with and without responsibility feedback and conventional interventions on participation in people with idiopathic Parkinson’s disease: study protocol for a randomized controlled trial

Mahsa Meimandi, Akram Azad, Jafar Haj Ghani, Fatemeh HojabriFard, Philip von Rosen, Naeeme Haji Alizadeh, Ghorban Taghizadeh

Decreasing consumption of sugar-sweetened beverages and Raising tap water consumption through Interventions based on Nutrition and sustainability for Kids: study protocol of the “DRINK” cluster randomised controlled trial

Katia Castetbon, Wassila Assakali, Isabelle Thiébaut, Lucille Desbouys

  • Open Access
  • Study protocol

A randomised controlled trial in preterm infants comparing prophylactic with selective “less invasive surfactant administration” (pro.LISA)

Wolfgang Göpel, Tanja K. Rausch, Barbara Mitschdörfer, Silke Mader, Egbert Herting, Inke R. König, Guido Stichtenoth, Thomas Höhn, Anja Stein, Hagen Bayer, Susanne Schmidtke, Barabara Naust, Claudia Roll, Axel Franz, Moritz Wolff, Anna Siemes, Katja Schneider, Jana Katharina Dieks, Hans Fuchs, Thorsten Körner, Michael Schroth, Frank Dohle, Thomas Völkl, Christoph Härtel, Levente Bejo, Welfhard Schneider

Evaluation of negative binomial and zero-inflated negative binomial models for the analysis of zero-inflated count data: application to the telemedicine for children with medical complexity trial

Kyung Hyun Lee, Claudia Pedroza, Elenir B. C. Avritscher, Ricardo A. Mosquera, Jon E. Tyson

  • Open Access
  • Correction

Correction: Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection

M. Masiá, S. Padilla, G. Estañ, J. Portu, A. Silva, A. Rivero, A. González-Cordón, L. García-Fraile, O. Martínez, E. Bernal, C. Galera, V. Boix Martínez, J. Macias, M. Montero, D. García-Rosado, M. J. Vivancos-Gallego, J. Llenas-García, M. Torralba, J. A. García, V. Agulló, M. Fernández-González, F. Gutiérrez, E. Martínez

RELEASE (REdressing Long-tErm Antidepressant uSE): protocol for a 3-arm pragmatic cluster randomised controlled trial effectiveness-implementation hybrid type-1 in general practice

Katharine A. Wallis, Maria Donald, Mark Horowitz, Joanna Moncrieff, Robert S. Ware, Joshua Byrnes, Karen Thrift, MaryAnne Cleetus, Idin Panahi, Nicholas Zwar, Mark Morgan, Chris Freeman, Ian Scott

Effect of a telerehabilitation exercise program versus a digital booklet with self-care for patients with chronic non-specific neck pain: a protocol of a randomized controlled trial assessor-blinded, 3 months follow-up

Juliene Corrêa Barbosa, Josielli Comachio, Amelia Pasqual Marques, Bruno Tirotti Saragiotto, Mauricio Oliveira Magalhaes

The effectiveness and cost-effectiveness of a group domestic abuse perpetrator programme: protocol for a randomised controlled trial

Karen Morgan, Mei-See Man, Rachael Bloomer, Madeleine Cochrane, Melissa Cole, Sandi Dheensa, Nathan Eisenstadt, Gene Feder, Daisy M. Gaunt, Rwth Leach, Rebecca Kandiyali, Sian Noble, Tim J. Peters, Beverly A. Shirkey, Helen Cramer

  • Open Access
  • Correction

Correction: A cross-sectional survey of potential factors, motivations, and barriers influencing research participation and retention among people who use drugs in the rural USA

Angela T. Hetrick, April M. Young, Miriam R. Elman, Sarann Bielavitz, Rhonda L. Alexander, Morgan Brown, Elizabeth Needham Waddell, P. Todd Korthuis, Kathryn E. Lancaster

  • Open Access
  • Cough
  • Methodology

Assessment of radio(chemo)therapy-related dysphagia in head and neck cancer patients based on cough-related acoustic features: a prospective phase II national clinical trial (ACCOUGH-P/A trial)

Sofiana Mootassim-Billah, Gwen Van Nuffelen, Jean Schoentgen, Marc De Bodt, Dirk Van Gestel

Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial

Hannah E. Frank, Laura Evans, Gary Phillips, RPhillip Dellinger, Jessyca Goldstein, Lori Harmon, David Portelli, Nima Sarani, Christa Schorr, Kathleen M. Terry, Sean R. Townsend, Mitchell M. Levy

Implementation and evaluation of a multi-level mental health promotion intervention for the workplace (MENTUPP): study protocol for a cluster randomised controlled trial

Ella Arensman, Mallorie Leduc, Cliodhna O’Brien, Paul Corcoran, Eve Griffin, Caleb Leduc, Evelien Coppens, Fotini Tsantila, Victoria Ross, Kahar Abdulla, Pia Hauck, Benedikt L. Amann, Birgit Aust, Arlinda Cerga Pashoja, Johanna Cresswell-Smith, Luigia D’Alessandro, Naim Fanaj, Birgit A. Greiner, Jeroen Luyten, Sharna Mathieu, Margaret Maxwell, Gentiana Qirjako, Hanna Reich, Sarita Sanches, Monika Ditta Tóth, Joseph Kilroy, Karen Michell, Nicola Reavley, David McDaid, Chantal Van Audenhove, Ainslie O’Connor, Ana Moreno-Alcázar, Andia Meksi, Andras Szekely, Anthony LaMontagne, Ariel Como, Arilda Dushaj, Asmae Doukani, Azucena Justicia, Bridget Hogg, Carolyn Holland, Charlotte Paterson, Chris Lockwood, Daniel Guinart, Doireann Ní Dhálaigh, Dooyoung Kim, Eileen Williamson, Eva Zsak, Genc Burazeri, Grace Cully, Grace Davey, György Purebl, Ilinca Serbanescu, Jaap van Weeghel, Juan Carlos Medina Alcaraz, Joe Eustace, Juliane Hug, Kairi Kõlves, Karen Mulcahy, Katherine Thomson, Kristian Wahlbeck, Lars de Winter, Laura Cox, Marta Fontana, Peter Trembeczky, Pia Driessen, Rebecca Lohmann-Devantier, Reiner Rugulies, Ruth Benson, Saara Rapeli, Sarah Ihinonvien, Sevim Mustafa, Stefan Hackel, Susan Alexander, Tanya King, Ulrich Hegerl, Vanda Scott, Wendy Orchard

Correction: Can dexamethasone improve postoperative sleep and postoperative delirium in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy? Protocol for a prospective, randomized, double-blind, controlled study

Yaping Shi, Qingyu Sun, Yue Wang, Chunting Chen, Jianfei Jin, Wei Wang, Yuting Lu, Yi Hua, Jianming Liu, Jinjun Bian, Yi Zhou

A novel shared decision-making (SDM) tool for anticoagulation management in atrial fibrillation: protocol for a prospective, cluster randomized controlled trial

Mang-Mang Pan, Chi Zhang, Long Shen, Jing-Jing Sha, Hui Shen, Yi-Dan Yan, Jia Wang, Xin Wang, Hou-Wen Lin, Zhi-Chun Gu

Dual tracer navigation for lymph node dissection in laparoscopic radical gastrectomy (DANCE trial): a protocol for a prospective, randomized clinical trial

Yanjun Lu, Shichao Ai, Peng Song, Yan Sun, Xiaofei Shen, Feng Sun, Qiongyuan Hu, Zhiyan Li, Meng Wang, Xiaofeng Lu, Wenxian Guan, Song Liu

The impact of an oral nutritional supplement on body weight gain in older adults with malnutrition: an open-label randomized controlled trial

Ranil Jayawardena, Prasani Wickramawardhane, Chamila Dalpatadu, Andrew P. Hills, Priyanga Ranasinghe

Frequency of screening and SBT Technique Trial—North American Weaning Collaboration (FAST-NAWC): an update to the protocol and statistical analysis plan

Karen E. A. Burns, Myriam Lafrienier-Roula, Nicholas S. Hill, Deborah J. Cook, Andrew J. E. Seely, Bram Rochwerg, Michael Mayette, Frederick D’Aragon, John W. Devlin, Peter Dodek, Maged Tanios, Audrey Gouskos, Alexis F. Turgeon, Pierre Aslanian, Ying Tung Sia, Jeremy R. Beitler, Robert Hyzy, Gerard J. Criner, Elias Baedorf Kassis, Jennifer L. Y. Tsang, Maureen O. Meade, Janice M. Liebler, Jessica T. Y. Wong, Kevin E. Thorpe

The antidepressant effect of intermittent theta burst stimulation (iTBS): study protocol for a randomized double-blind sham-controlled trial

Marte Christine Ørbo, Ole K. Grønli, Camilla Larsen, Torgil R. Vangberg, Oddgeir Friborg, Zsolt Turi, Matthias Mittner, Gabor Csifcsak, Per M. Aslaksen

A self-managed exercise therapy program for wrist osteoarthritis: study protocol for a randomized controlled trial

Sara L. Larsson, Elisabeth Ekstrand, Lars B. Dahlin, Anders Björkman, Elisabeth Brogren

  • Open Access
  • Correction

Correction: Prospective randomized study on the efficacy of three-dimensional reconstructions of bronchovascular structures on preoperative chest CT scan in patients who are candidates for pulmonary segmentectomy surgery: the PATCHES (Prospective rAndomized sTudy efficaCy of tHree-dimensional rEconstructions Segmentecomy) study protocol

Francesco Zaraca, Andreas Kirschbaum, Marco Damiano Pipitone, Luca Bertolaccini

Correction: Effects of half-dose spiomet treatment in girls with early puberty and accelerated bone maturation: a multicenter, randomized, placebo-controlled study protocol

Judit Bassols, Francis de Zegher, Marta Diaz, Gemma Carreras‑Badosa, Cristina Garcia‑Beltran, Elsa Puerto‑Carranza, Cora Oliver‑Vila, Paula Casano, Celine Alicia Franco, Rita Malpique, Abel Lopez‑Bermejo, Lourdes Ibanez

  • Open Access
  • Rape
  • Correction

Correction: Modified prolonged exposure therapy as Early Intervention after Rape (The EIR-study): study protocol for a multicenter randomized add-on superiority trial

Tina Haugen, Joar Øveraas Halvorsen, Oddgeir Friborg, Melanie Rae Simpson, Paul Jarle Mork, Gustav Mikkelsen, Ask Elklit, Barbara O. Rothbaum, Berit Schei, Cecilie Hagemann

  • Open Access
  • Correction

Correction: Efect of Tan Tui combined with kinesio taping on the posture control of patients with PFPS: protocol for a randomized controlled trial

Youhua Li, Shuai Tian, Lu Jin, Jixin Li, Xianfa Liu, Jingjing Ji

Effectiveness and safety of digital rectal stimulation and abdominal massage for neurogenic bowel dysfunction in stroke patients: a randomized controlled trial protocol

Sumin Ma, Xiaoyan Fan, Ying He, Chengjuan Li, Dandan Qu, Yanli Man

Delirium and neuropsychological recovery among emergency general surgery survivors (DANE): study protocol for a randomized controlled trial and collaborative care intervention

Sanjay Mohanty, Emma Holler, Damaris Ortiz, Ashley Meagher, Anthony Perkins, Peggy Bylund, Babar Khan, Frederick Unverzagt, Hupuing Xu, Angela Ingraham, Malaz Boustani, Ben Zarzaur

Community-based management of a five-arm randomised clinical trial in COVID-19 outpatients in South Africa: challenges and opportunities

Nomathemba Chandiwana, Chelsea Kruger, Naomi Richardson, Sibongiseni Nxumalo, Nkoleleng Mashilo, Yengiwe Dineka, Ntanganedzeni Mudau, Hilary Johnstone, Wookyung Kim, Chung Ju, Sarah Arbe-Barnes, Anne Claire Marrast, Julia Flynn, Willem D. Francois Venter

Bacillus Calmette-Guérin vaccination as defense against SARS-CoV-2 (BADAS): a randomized controlled trial to protect healthcare workers in the USA by enhanced trained immune responses

Andrew R. DiNardo, Moshe Arditi, Ashish M. Kamat, Kent J. Koster, Santiago Carrero, Tomoki Nishiguchi, Maxim Lebedev, Aaron B. Benjamin, Pablo Avalos, Marisa Lozano, Madeleine G. Moule, Brittany McCune, Baysia Herron, Malik Ladki, Daanish Sheikh, Matthew Spears, Ivan A. Herrejon, Courtney Dodge, Sathish Kumar, Robert W. Hutchison, Theresa U. Ofili, Lynne A. Opperman, Jessica A. Bernard, Seth P. Lerner, George Udeani, Gabriel Neal, Mihai G. Netea, Jeffrey D. Cirillo

The effect of a tailored message package for reducing antibiotic use among respiratory tract infection patients in rural Anhui, China: a cluster randomized controlled trial protocol

Rong Liu, Qun Xue, Xiaoqin Guan, Guocheng Li, Tingting Zhang, Debin Wang, Linhai Zhao, Xingrong Shen

Preconditioning of the motor network with repetitive navigated transcranial magnetic stimulation (rnTMS) to improve oncological and functional outcome in brain tumor surgery: a study protocol for a randomized, sham-controlled, triple-blind clinical trial

Melina Engelhardt, Ulrike Grittner, Sandro Krieg, Thomas Picht

Mobile phone text messaging plus motivational interviewing versus usual care: study protocol for a randomized controlled trial to evaluate effects on breastfeeding, child health, and survival outcomes, among women living with HIV (MTI-MI)

Moleen Zunza, Lehana Thabane, Louise Kuhn, Christine Els, Mark F. Cotton, Taryn Young

  • Open Access
  • Commentary

Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing

Martin Law, Dominique-Laurent Couturier, Babak Choodari-Oskooei, Phillip Crout, Carrol Gamble, Peter Jacko, Philip Pallmann, Mark Pilling, David S. Robertson, Michael Robling, Matthew R. Sydes, Sofía S. Villar, James Wason, Graham Wheeler, S. Faye Williamson, Christina Yap, Thomas Jaki

COMPASS: deCOMPressing stomA and two-Stage elective resection vs. emergency reSection in patients with left-sided obstructive colon cancer

Mathieu Pecqueux, Marius Distler, Olga Radulova-Mauersberger, Ulrike Neckmann, Sandra Korn, Christian Praetorius, Johannes Fritzmann, Anna Klimova, Jürgen Weitz, Christoph Kahlert

  • Open Access
  • Obesity
  • Study protocol

The (cost) effectiveness of a very low-energy diet intervention with the use of eHealth in patients with type 2 diabetes and obesity: study protocol for a randomised controlled non-inferiority trial (E-diet trial)

Karlijn A. M. Geurts, Behiye Ozcan, Mandy van Hoek, Roel van de Laar, Jolande van Teeffelen, Joost van Rosmalen, Elisabeth F. C. van Rossum, Kirsten A. Berk

Prednisolone Versus Colchicine for Acute Gout in Primary Care (COPAGO): protocol for a two-arm multicentre, pragmatic, prospective, randomized, double-blind, controlled clinical trial of prednisolone and colchicine for non-inferiority with a parallel group design

Julia Truthmann, Julia Freyer Martins Pereira, Adrian Richter, Franziska Schuster, Amelie Witte, Susanne Böhm, Alexandra Greser, Petra Kamin, Sylvia Stracke, Marcus Dörr, Robin Bülow, Stefan Engeli, Ildikó Gágyor, Eva Hummers, Jean-François Chenot

Testing the combination of Feeling Safe and peer counselling against formulation-based cognitive behaviour therapy to promote psychological wellbeing in people with persecutory delusions: study protocol for a randomized controlled trial (the Feeling Safe-NL Trial)

Eva Tolmeijer, Felicity Waite, Louise Isham, Laura Bringmann, Robin Timmers, Arjan van den Berg, Hanneke Schuurmans, Anton B. P. Staring, Paul de Bont, Rob van Grunsven, Gert Stulp, Ben Wijnen, Mark van der Gaag, Daniel Freeman, David van den Berg

Empagliflozin and colchicine in patients with reduced left ventricular ejection fraction following ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: a study protocol for a randomized, double-blinded, three-arm parallel-group, controlled trial

Sajad Khiali, Mohammadreza Taban-Sadeghi, Parvin Sarbakhsh, Naser Khezerlouy-Aghdam, Hossein Namdar, Rezvanieh Salehi, Afra Rezagholizadeh, Taher Entezari-Maleki

Antidepressants for the prevention of depression following first-episode psychosis (ADEPP): study protocol for a multi-centre, double-blind, randomised controlled trial

Edward R. Palmer, Siân Lowri Griffiths, Ben Watkins, Tyler Weetman, Ryan Ottridge, Smitaa Patel, Rebecca Woolley, Sarah Tearne, Pui Au, Eleanor Taylor, Zara Sadiq, Hareth Al-Janabi, Barnaby Major, Charlotte Marriott, Nusrat Husain, Mohammad Zia Ul Haq Katshu, Domenico Giacco, Nicholas M. Barnes, James T. R. Walters, Thomas R. E. Barnes, Max Birchwood, Richard Drake, Rachel Upthegrove

  • Open Access
  • Study protocol

High-flow nasal cannula (HFNC) vs continuous positive airway pressure (CPAP) vs nasal intermittent positive pressure ventilation as primary respiratory support in infants of ≥ 32 weeks gestational age (GA): study protocol for a three-arm multi-center randomized controlled trial

Rong Zhou, Tao Xiong, Jun Tang, Yi Huang, Wenli Liu, Jun Zhu, Chao Chen, Lingyue Gong, Ke Tian, Aoyu Wang, Dezhi Mu

Digital CBTI hubs as a treatment augmentation strategy in military clinics: study protocol for a pragmatic randomized clinical trial

Anne Germain, Megan Wolfson, Matthew S. Brock, Brian O’Reilly, Hunter Hearn, Shelley Knowles, Vincent Mysliwiec, Meredith L. Wallace

  • Open Access
  • Letter

Response to Merz

Pepijn Al, Jamie Brehaut, Charles Weijer

Study protocol for a randomized, controlled, multicentre, pragmatic trial with Rehabkompassen®—a digital structured follow-up tool for facilitating patient-tailored rehabilitation in persons after stroke

Xiaolei Hu, Per Liv, Erik Lundström, Fredrik Norström, Olof Lindahl, Kristian Borg, Katharina S. Sunnerhagen

MITIG.RA: study protocol of a tailored psychological intervention for managing fatigue in rheumatoid arthritis randomized controlled trial

Cátia Duarte, Ruben L. F. Spilker, Cláudia Paiva, Ricardo J. O. Ferreira, José A. Pereira da Silva, Ana M. Pinto

Randomised controlled trial of the Community Navigator programme to reduce loneliness and depression for adults with treatment-resistant depression in secondary community mental health services: trial protocol

Theodora Stefanidou, Gareth Ambler, Gergely Bartl, Nick Barber, Jo Billings, Tumelo Bogatsu, Richard Carroll, Beverley Chipp, Maev Conneely, Anne-Marie Downey, Gamze Evlat, Rachael Hunter, Marie Le Novere, Glyn Lewis, Tanya Mackay, Steven Marwaha, Zubair Matin, Georgia Naughton, Chandani Nekitsing, Millie O’Sullivan, Vanessa Pinfold, Shengning Pan, Angela Sobers, Keith J. Thompson, Jerusaa Vasikaran, Martin Webber, Sonia Johnson, Brynmor Lloyd-Evans

  • Open Access
  • Care
  • Study protocol

Cerebral oximetry monitoring versus usual care for extremely preterm infants: a study protocol for the 2-year follow-up of the SafeBoosC-III randomised clinical trial

Marie Isabel Rasmussen, Mathias Lühr Hansen, Adelina Pellicer, Christian Gluud, Eugene Dempsey, Jonathan Mintzer, Simon Hyttel-Sørensen, Anne Marie Heuchan, Cornelia Hagmann, Ebru Ergenekon, Gabriel Dimitriou, Gerhard Pichler, Gunnar Naulaers, Guoqiang Cheng, Jakub Tkaczyk, Hans Fuchs, Monica Fumagalli, Saudamini Nesargi, Siv Fredly, Tomasz Szczapa, Anne Mette Plomgaard, Bo Mølholm Hansen, Janus Christian Jakobsen, Gorm Greisen

Correction: Surgical treatments for postamputation pain: study protocol for an international, double-blind, randomised controlled trial

Emily Pettersen, Paolo Sassu, Carina Reinholdt, Peter Dahm, Ola Rolfson, Anders Björkman, Marco Innocenti, Francesca Alice Pedrini, Juan Manuel Breyer, Aidan Roche, Andrew Hart, Lorraine Harrington, Adil Ladak, Hollie Power, Jacqueline Hebert, Max Ortiz-Catalan

A web-based educational therapy intervention associated with physical exercise to promote health in fibromyalgia in Brazil: the Amigos De Fibro (Fibro Friends) study protocol

Mateus Dias Antunes, Felipe Cayres Nogueira da Rocha Loures, Ingred Merllin Batista de Souza, Ariela Torres Cruz, Priscila de Oliveira Januário, Mara Maria Lisboa Santana Pinheiro, Ana Carolina Basso Schmitt, Elisa Frutos-Bernal, Ana María Martín-Nogueras, Amélia Pasqual Marques

  • Open Access
  • Study protocol

Doxapram versus placebo in preterm newborns: a study protocol for an international double blinded multicentre randomized controlled trial (DOXA-trial)

Jarinda A. Poppe, Robert B. Flint, Anne Smits, Sten P. Willemsen, Kelly K. Storm, Debbie H. Nuytemans, Wes Onland, Marten J. Poley, Willem P. de Boode, Katherine Carkeek, Vincent Cassart, Luc Cornette, Peter H. Dijk, Marieke A. C. Hemels, Isabelle Hermans, Matthias C. Hütten, Dorottya Kelen, Ellen H. M. de Kort, André A. Kroon, Julie Lefevere, Katleen Plaskie, Breanne Stewart, Michiel Voeten, Mirjam M. van Weissenbruch, Olivia Williams, Inge A. Zonnenberg, Thierry Lacaze-Masmonteil, Arjan B.te Pas, Irwin K. M. Reiss, Anton H. van Kaam, Karel Allegaert, G. Jeroen Hutten, Sinno H. P. Simons

  • Open Access
  • Research

e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence

E. J. Mitchell, D. Appelbe, A. Bravery, L. Culliford, H. Evans, A. J. Farrin, K. Gillies, K. Hood, S. B. Love, M. R. Sydes, P. R. Williamson, N. Wakefield

Sleep Technology Intervention to Target Cardiometabolic Health (STITCH): a randomized controlled study of a behavioral sleep extension intervention compared to an education control to improve sleep duration, blood pressure, and cardiometabolic health among adults with elevated blood pressure/hypertension

Kelly Glazer Baron, Jennifer Duffecy, Sara Simonsen, Adam Bress, Molly B. Conroy, Tom Greene, Chelsea Allen, Sofia Vallejo

  • Open Access
  • Study protocol

OCOSO2: study protocol for a single-blinded, multicentre, randomised controlled trial assessing a central venous oxygen saturation-based goal-directed therapy to reduce postoperative complications in high-risk patients after elective major surgery

Bruno Pastene, Matthieu Bernat, Karine Baumstark, Karine Bezulier, Yann Gricourt, Jean-Manuel De Guibert, Aude Charvet, Manon Colin, Marc Leone, Laurent Zieleskiewicz

  • Open Access
  • Study protocol

Is a preoperative multidisciplinary team meeting (cost)effective to improve outcome for high-risk adult patients undergoing noncardiac surgery: the PREPARATION study—a multicenter stepped-wedge cluster randomized trial

Jacqueline E. M. Vernooij, Romijn M. Boerlage, Carine J. M. Doggen, Benedikt Preckel, Carmen D. Dirksen, Barbara L. van Leeuwen, Rutger J. Spruit, Suzanne Festen, Hanneke van der Wal-Huisman, Jean P. van Basten, Cor J. Kalkman, Nick J. Koning, Koene van der Sloot, Esther M. Dias, Jasper E. Kal, Marjolein C. O. van den Nieuwenhuyzen, Manuela di Biase, Martin Hagenaars, Bies Oedairadjsingh, Taco van den Ende, Michel Timmerman, Zjuul Segers, Dominique H. P. A. M. Schoester, Kristy M. J. Vons, A. Filius, Wim van Harten, Rudolf W. Poolman, Michel M. P. J. Reijnen, Peter G. Noordzij, Barbara C. van Munster

  • Open Access
  • Acne
  • Research

Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial

Cherish Boxall, Susanne Renz, Zina Eminton, Jacqueline Nuttall, Alan Saji, Charlotte Cluff, Christopher Wilcox, Ingrid Muller, Alison M. Layton, Irene Soulsby, Miriam Santer

Effect of music breathing, a program based on mindful breathing and music listening therapy for promoting sense of coherence in young people: study protocol for a randomized controlled trial

Winnie Lai-Sheung Cheng, Anson Chui-Yan Tang, Mark Cheuk-Man Tsang, Lokki Lok-Ki Wong, Dag Körlin

An integrated personalized assistive devices approach to reduce the risk of foot ulcer recurrence in diabetes (DIASSIST): study protocol for a multicenter randomized controlled trial

Lisa E. Vossen, Jaap J. van Netten, Chantal D. Bakker, Heleen A. Berendsen, Tessa E. Busch-Westbroek, Edgar J. G. Peters, Louise W. E. Sabelis, Marcel G. W. Dijkgraaf, Sicco A. Bus

Randomized phase III trial evaluating motivational interviewing and text interventions to optimize adherence to breast cancer endocrine therapy (Alliance A191901): the GETSET protocol

Joannie Ivory, Stephanie B. Wheeler, Sarah Drier, Heather Gunn, David Zahrieh, Electra Paskett, Michelle Naughton, Rachel Wills, Kayla Swetel, Selina Chow, Katherine Reeder-Hayes

Minimally invasive versus open pancreatoduodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): study protocol for an international multicenter patient-blinded randomized controlled trial

Nine de Graaf, Anouk M. L. H. Emmen, Marco Ramera, Bergthor Björnsson, Ugo Boggi, Caro L. Bruna, Olivier R. Busch, Freek Daams, Giovanni Ferrari, Sebastiaan Festen, Jony van Hilst, Mathieu D’Hondt, Benedetto Ielpo, Tobias Keck, Igor E.