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Trials

Ausgabe 1/2017

Inhalt (630 Artikel)

Open Access Study protocol

Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME): study protocol for a randomised controlled trial

Sophie E. Rowbotham, Doug Cavaye, Rene Jaeggi, Jason S. Jenkins, Corey S. Moran, Joseph V. Moxon, Jenna L. Pinchbeck, Frank Quigley, Christopher M. Reid, Jonathan Golledge

Open Access Study protocol

Determining the impact of 24/7 phone support on hospital readmissions after aortic valve replacement surgery (the AVRre study): study protocol for a randomised controlled trial

Irene Lie, Stein Ove Danielsen, Theis Tønnessen, Svein Solheim, Marit Leegaard, Leiv Sandvik, Torbjørn Wisløff, Jonny Vangen, Tor Henning Røsstad, Philip Moons

Open Access Study protocol

The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial

Jennifer Fleming, Tamara Ownsworth, Emmah Doig, Lauren Hutton, Janelle Griffin, Melissa Kendall, David H. K. Shum

Open Access Study protocol

Prophylactic Melatonin for Delirium in Intensive Care (Pro-MEDIC): study protocol for a randomised controlled trial

F. Eduardo Martinez, Matthew Anstey, Andrew Ford, Brigit Roberts, Miranda Hardie, Robert Palmer, Lynn Choo, David Hillman, Michael Hensley, Erin Kelty, Kevin Murray, Bhajan Singh, Bradley Wibrow

Open Access Study protocol

The effect of a novel probiotic on metabolic biomarkers in adults with prediabetes and recently diagnosed type 2 diabetes mellitus: study protocol for a randomized controlled trial

Talia Palacios, Luis Vitetta, Samantha Coulson, Claire D. Madigan, Gareth S. Denyer, Ian D. Caterson

Open Access Study protocol

Traditional Chinese medicine combination therapy for patients with steroid-dependent ulcerative colitis: study protocol for a randomized controlled trial

Kai Zheng, Hong Shen, Jia Jia, Yuelin Lu, Lei Zhu, Lu Zhang, Zhaofeng Shen

Open Access Study protocol

Improving Nursing Home Care through Feedback On PerfoRMance Data (INFORM): Protocol for a cluster-randomized trial

Matthias Hoben, Peter G. Norton, Liane R. Ginsburg, Ruth A. Anderson, Greta G. Cummings, Holly J. Lanham, Janet E. Squires, Deanne Taylor, Adrian S. Wagg, Carole A. Estabrooks

Open Access Study protocol

Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial

Seung-Yeon Cho, Seung-Bo Yang, Hee Sup Shin, Seung Hwan Lee, Jun Seok Koh, Seungwon Kwon, Woo-Sang Jung, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko, Seong-Uk Park

Open Access Study protocol

PANSAID – PAracetamol and NSAID in combination: study protocol for a randomised trial

Kasper Højgaard Thybo, Daniel Hägi-Pedersen, Jørn Wetterslev, Jørgen Berg Dahl, Henrik Morville Schrøder, Hans Henrik Bülow, Jan Gottfrid Bjørck, Ole Mathiesen

Open Access Study protocol

The SYGMA programme of phase 3 trials to evaluate the efficacy and safety of budesonide/formoterol given ‘as needed’ in mild asthma: study protocols for two randomised controlled trials

Paul M. O’Byrne, J. Mark FitzGerald, Nanshan Zhong, Eric Bateman, Peter J. Barnes, Christina Keen, Gun Almqvist, Kristine Pemberton, Carin Jorup, Stefan Ivanov, Helen K. Reddel

Open Access Study protocol

A fixed inhaled nitrous oxide/oxygen mixture as an analgesic for adult cancer patients with breakthrough pain: study protocol for a randomized controlled trial

Qiang Liu, Yu Wang, Xiang-Jiang Luo, Ning-Ju Wang, Ping Chen, Xin Jin, Guo-Xia Mu, Xiao-Min Chai, Yue-Juan Zhang, Yu-Xiang Li, Jian-Qiang Yu

Open Access Study protocol

The efficacy of varenicline in achieving abstinence among waterpipe tobacco smokers – study protocol for a randomized controlled trial

Raana Zahid, Omara Dogar, Sonia Mansoor, Amina Khan, Mona Kanaan, Mohammed Jawad, Jasjit S. Ahluwalia, Kamran Siddiqi

Open Access Study protocol

Electroacupuncture plus moxibustion therapy for patients with major depressive disorder: study protocol for a randomized controlled trial

Mikyung Kim, Eun-Ji Choi, Sung-Phil Kim, Jung-Eun Kim, Hyo-Ju Park, Ae-Ran Kim, Bok-Nam Seo, O-Jin Kwon, Jung Hyo Cho, Sun-Yong Chung, Joo-Hee Kim

Open Access Study protocol

Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial

Samuel Bulteau, Veronique Sébille, Guillemette Fayet, Veronique Thomas-Ollivier, Thibault Deschamps, Annabelle Bonnin-Rivalland, Edouard Laforgue, Anne Pichot, Pierre Valrivière, Elisabeth Auffray-Calvier, June Fortin, Yann Péréon, Jean-Marie Vanelle, Anne Sauvaget

Open Access Research

Physical activity and nutrition behaviour outcomes of a cluster-randomized controlled trial for adults with metabolic syndrome in Vietnam

Van Dinh Tran, Andy H. Lee, Jonine Jancey, Anthony P. James, Peter Howat, Le Thi Phuong Mai

Open Access Study protocol

Mailed HPV self-sampling for cervical cancer screening among underserved minority women: study protocol for a randomized controlled trial

Erin Kobetz, Julia Seay, Anthony Amofah, Larry Pierre, Jordan Baeker Bispo, Dinah Trevil, Martha Gonzalez, Martine Poitevien, Tulay Koru-Sengul, Olveen Carrasquillo

Open Access Research

A lifestyle intervention among elderly men on active surveillance for non-aggressive prostate cancer: a randomised feasibility study with whole-grain rye and exercise

Anne Kirstine Eriksen, Rikke Dalgaard Hansen, Michael Borre, Ryan Godsk Larsen, Jeppe Munthe Jensen, Kristian Overgaard, Mette Borre, Cecilie Kyrø, Rikard Landberg, Anja Olsen, Anne Tjønneland

Open Access Study protocol

Spinal versus general anaesthesia in surgery for inguinodynia (SPINASIA trial): study protocol for a randomised controlled trial

Willem A. R. Zwaans, Léon H. P. M. le Mair, Marc R. M. Scheltinga, Rudi M. H. Roumen

Open Access Study protocol

Efficacy of gabapentin for prevention of postherpetic neuralgia: study protocol for a randomized controlled clinical trial

Manuel Rullán, Oana Bulilete, Alfonso Leiva, Aina Soler, Antonia Roca, María José González-Bals, Patricia Lorente, Joan Llobera, Martí Cladera, Catalina Comas, María Antonia Mir, Apolonia Cifre, Biel Lliteras, Salvador Gestoso, Antoni Jover, Francisca Bestard, Francisca Comas, Luis López, Rosa Ortuño, Joan Peiro, María Cerdó, Violeta Ramírez, Merce Gutierrez, Rosemary Argüelles, María Dolores Gutierrrez

Open Access Study protocol

SONOlysis in prevention of Brain InfaRctions During Internal carotid Endarterectomy (SONOBIRDIE) trial – study protocol for a randomized controlled trial

Tomáš Hrbáč, David Netuka, Vladimír Beneš, Vladimír Nosáľ, Petra Kešnerová, Aleš Tomek, Táňa Fadrná, Vladimír Beneš Jr, Jiří Fiedler, Vladimír Přibáň, Miroslav Brozman, Kateřina Langová, Roman Herzig, David Školoudík

Open Access Study protocol

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study)

Byung-Cheul Shin, Me-riong Kim, Jae-Heung Cho, Jae-Young Jung, Koh-Woon Kim, Jun-Hwan Lee, Kibong Nam, Min ho Lee, Eui-Hyoung Hwang, Kwang-Ho Heo, Namkwen Kim, In-Hyuk Ha

Open Access Study protocol

Moderated online social therapy for carers of young people recovering from first-episode psychosis: study protocol for a randomised controlled trial

John Gleeson, Reeva Lederman, Helen Herrman, Peter Koval, Dina Eleftheriadis, Sarah Bendall, Sue M. Cotton, Mario Alvarez-Jimenez

Open Access Erratum

Erratum to: Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial

Dimitrios A. Koutoukidis, Rebecca J. Beeken, Ranjit Manchanda, Matthew Burnell, M. Tish Knobf, Anne Lanceley

Open Access Study protocol

The (cost-)effectiveness of a patient-tailored intervention programme to enhance adherence to antihypertensive medication in community pharmacies: study protocol of a randomised controlled trial

Danielle M. van der Laan, Petra J. M. Elders, Christel C. L. M. Boons, Judith E. Bosmans, Giel Nijpels, Jacqueline G. Hugtenburg

Open Access Study protocol

Can an educational podcast improve the ability of parents of primary school children to assess the reliability of claims made about the benefits and harms of treatments: study protocol for a randomised controlled trial

Daniel Semakula, Allen Nsangi, Matt Oxman, Astrid Austvoll-Dahlgren, Sarah Rosenbaum, Margaret Kaseje, Laetitia Nyirazinyoye, Atle Fretheim, Iain Chalmers, Andrew D. Oxman, Nelson K. Sewankambo

Open Access Review

Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features

Michael J. Grayling, James M. S. Wason, Adrian P. Mander

Open Access Editorial

Review and publication of protocol submissions to Trials – what have we learned in 10 years?

Tianjing Li, Isabelle Boutron, Rustam Al-Shahi Salman, Erik Cobo, Ella Flemyng, Jeremy M. Grimshaw, Douglas G. Altman

Open Access Study protocol

The impact of torasemide on haemodynamic and neurohormonal stress, and cardiac remodelling in heart failure – TORNADO: a study protocol for a randomized controlled trial

Paweł Balsam, Krzysztof Ozierański, Agata Tymińska, Renata Główczyńska, Michał Peller, Anna Fojt, Andrzej Cacko, Bartosz Sieradzki, Elwira Bakuła, Maciej Markulis, Robert Kowalik, Zenon Huczek, Krzysztof J. Filipiak, Grzegorz Opolski, Marcin Grabowski

Open Access Study protocol

Impact of the duration of antibiotics on clinical events in patients with Pseudomonas aeruginosa ventilator-associated pneumonia: study protocol for a randomized controlled study

Adrien Bouglé, Arnaud Foucrier, Hervé Dupont, Philippe Montravers, Alexandre Ouattara, Pierre Kalfon, Pierre Squara, Tabassome Simon, Julien Amour

Open Access Study protocol

A home-based exercise program for children with congenital heart disease following interventional cardiac catheterization: study protocol for a randomized controlled trial

Qing Du, Yasser Salem, Hao (Howe) Liu, Xuan Zhou, Sun Chen, Nan Chen, Xiaoyan Yang, Juping Liang, Kun Sun

Open Access Study protocol

Endoscopic sinus surgery in adult patients with chronic rhinosinusitis with nasal polyps (PolypESS): study protocol for a randomised controlled trial

Evelijn S. Lourijsen, Corianne A. J. M. de Borgie, Marleen Vleming, Wytske J. Fokkens

Open Access Study protocol

Effectiveness of an implementation optimisation intervention aimed at increasing parent engagement in HENRY, a childhood obesity prevention programme - the Optimising Family Engagement in HENRY (OFTEN) trial: study protocol for a randomised controlled trial

Maria Bryant, Wendy Burton, Bonnie Cundill, Amanda J. Farrin, Jane Nixon, June Stevens, Kim Roberts, Robbie Foy, Harry Rutter, Suzanne Hartley, Sandy Tubeuf, Michelle Collinson, Julia Brown

Open Access Study protocol

NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial

Friederike Blume, Justin Hudak, Thomas Dresler, Ann-Christine Ehlis, Jan Kühnhausen, Tobias J. Renner, Caterina Gawrilow

Open Access Study protocol

Telemedical support for prehospital Emergency Medical Service (TEMS trial): study protocol for a randomized controlled trial

Ana Stevanovic, Stefan Kurt Beckers, Michael Czaplik, Sebastian Bergrath, Mark Coburn, Jörg Christian Brokmann, Ralf-Dieter Hilgers, Rolf Rossaint, Marc Felzen, Frederik Hirsch, Jürgen Wolff, Nils Lapp, Lothar Albrecht, Christof Koerentz

Open Access Study protocol

Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+): study protocol for a randomised controlled trial

Emily Peckham, Catherine Arundel, Della Bailey, Stuart Brownings, Caroline Fairhurst, Paul Heron, Jinshuo Li, Steve Parrott, Simon Gilbody

Open Access Study protocol

The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial

Charlotte Mühlmann, Trine Madsen, Carsten Hjorthøj, Ad Kerkhof, Merete Nordentoft, Annette Erlangsen

Open Access Study protocol

Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC): study protocol for a randomised controlled trial

Enoch Akowuah, Andrew T. Goodwin, W. Andrew Owens, Helen C. Hancock, Rebecca Maier, Adetayo Kasim, Adrian Mellor, Khalid Khan, Gavin Murphy, James Mason

Open Access Study protocol

Targeting functional fitness, hearing and health-related quality of life in older adults with hearing loss: Walk, Talk 'n' Listen, study protocol for a pilot randomized controlled trial

Justin Lambert, Rouzbeh Ghadry-Tavi, Kate Knuff, Marc Jutras, Jodi Siever, Paul Mick, Carolyn Roque, Gareth Jones, Jonathan Little, Harry Miller, Colin Van Bergen, Donna Kurtz, Mary Ann Murphy, Charlotte Ann Jones

Open Access Research

Tranexamic acid in bleeding trauma patients: an exploration of benefits and harms

Ian Roberts, Phil Edwards, David Prieto, Miland Joshi, Abda Mahmood, Katharine Ker, Haleema Shakur

Open Access Study protocol

Effectiveness of the addition of therapeutic alliance with minimal intervention in the treatment of patients with chronic, nonspecific low back pain and low risk of involvement of psychosocial factors: a study protocol for a randomized controlled trial (TalkBack trial)

Felipe Ribeiro Cabral Fagundes, Caique de Melo do Espírito Santo, Francine Mendonça de Luna Teixeira, Thaís Vanelli Tonini, Cristina Maria Nunes Cabral

Open Access Study protocol

ASPirin Intervention for the REDuction of colorectal cancer risk (ASPIRED): a study protocol for a randomized controlled trial

David A. Drew, Samantha M. Chin, Katherine K. Gilpin, Melanie Parziale, Emily Pond, Madeline M. Schuck, Kathleen Stewart, Meaghan Flagg, Crystal A. Rawlings, Vadim Backman, Peter J. Carolan, Daniel C. Chung, Francis P. Colizzo III, Matthew Freedman, Manish Gala, John J. Garber, Curtis Huttenhower, Dmitriy Kedrin, Hamed Khalili, Douglas S. Kwon, Sanford D. Markowitz, Ginger L. Milne, Norman S. Nishioka, James M. Richter, Hemant K. Roy, Kyle Staller, Molin Wang, Andrew T. Chan

Open Access Research

The pathway to RCTs: how many roads are there? Examining the homogeneity of RCT justification

Jeffrey Tin Yu Chow, Kevin Lam, Abdul Naeem, Zarique Z. Akanda, Francie Fengqin Si, William Hodge

Open Access Study protocol

Optimizing adalimumab treatment in psoriasis with concomitant methotrexate (OPTIMAP): study protocol for a pragmatic, single-blinded, investigator-initiated randomized controlled trial

C. I. Busard, S. P. Menting, J. S. van Bezooijen, J. M. van den Reek, B. A. Hutten, E. P. Prens, E. M. de Jong, M. B. van Doorn, P. I. Spuls

Open Access Research

Investigating the effect of independent, blinded digital image assessment on the STOP GAP trial

Emily Patsko, Peter J. Godolphin, Kim S. Thomas, Trish Hepburn, Eleanor J. Mitchell, Fiona E. Craig, Philip M. Bath, Alan A. Montgomery

Open Access Letter

The COMET Initiative database: progress and activities update (2015)

E. Gargon, P. R. Williamson, D. G. Altman, J. M. Blazeby, S. Tunis, M. Clarke

Open Access Study protocol

The ACHRU-CPP versus usual care for older adults with type-2 diabetes and multiple chronic conditions and their family caregivers: study protocol for a randomized controlled trial

Maureen Markle-Reid, Jenny Ploeg, Kimberly D. Fraser, Kathryn Ann Fisher, Noori Akhtar-Danesh, Amy Bartholomew, Amiram Gafni, Andrea Gruneir, Sandra P. Hirst, Sharon Kaasalainen, Caralyn Kelly Stradiotto, John Miklavcic, Carlos Rojas-Fernandez, Cheryl A. Sadowski, Lehana Thabane, Jean A. C. Triscott, Ross Upshur

Open Access Study protocol

App-based serious gaming for training of chest tube insertion: study protocol for a randomized controlled trial

Mirco Friedrich, Christian Bergdolt, Patrick Haubruck, Thomas Bruckner, Karl-Friedrich Kowalewski, Beat Peter Müller-Stich, Michael C. Tanner, Felix Nickel

Open Access Study protocol

Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial

Aurélien Dupré, David Pérol, Ellen Blanc, Patrice Peyrat, Valéria Basso, Yao Chen, Jérémy Vincenot, Anthony Kocot, David Melodelima, Michel Rivoire

Open Access Study protocol

The WE-Study: does botulinum toxin A make walking easier in children with cerebral palsy?: Study protocol for a randomized controlled trial

Siri Merete Brændvik, Karin Roeleveld, Guro Lillemoen Andersen, Anne Elisabeth Ross Raftemo, Kjersti Ramstad, Jasmina Majkic-Tajsic, Torarin Lamvik, Bendik Lund, Turid Follestad, Torstein Vik

Open Access Research

Staff experiences of closing out a clinical trial involving withdrawal of treatment: qualitative study

Julia Lawton, David White, David Rankin, Jackie Elliott, Carolin Taylor, Cindy Cooper, Simon Heller, Nina Hallowell

Open Access Study protocol

The TECH@HOME study, a technological intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol for a randomized controlled trial

Agneta Malmgren Fänge, Steven M. Schmidt, Maria H. Nilsson, Gunilla Carlsson, Anna Liwander, Caroline Dahlgren Bergström, Paolo Olivetti, Per Johansson, Carlos Chiatti

Open Access Study protocol

Impact of a pharmacist-led medication review on hospital readmission in a pediatric and elderly population: study protocol for a randomized open-label controlled trial

Pierre Renaudin, Karine Baumstarck, Aurélie Daumas, Marie-Anne Esteve, Stéphane Gayet, Pascal Auquier, Michel Tsimaratos, Patrick Villani, Stéphane Honore

Open Access Study protocol

The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial

Barnaby Young, Sapna Sadarangani, Haur Sen Yew, Chee Fu Yung, Yee Sin Leo, Mark I-Cheng Chen, Annelies Wilder-Smith

Open Access Study protocol

Substitution of ethambutol with linezolid during the intensive phase of treatment of pulmonary tuberculosis: study protocol for a prospective, multicenter, randomized, open-label, phase II trial

Ji Yeon Lee, Deog Kyeom Kim, Jung-Kyu Lee, Ho Il Yoon, Ina Jeong, Eunyoung Heo, Young Sik Park, Jae Ho Lee, Sung Soo Park, Sang-Min Lee, Chang-Hoon Lee, Jinwoo Lee, Sun Mi Choi, Jong Sun Park, Joon-Sung Joh, Young-Jae Cho, Yeon Joo Lee, Se Joong Kim, Young Ran Hwang, Hyeonjeong Kim, Jongeun Ki, Hyungsook Choi, Jiyeon Han, Heejung Ahn, Seokyung Hahn, Jae-Joon Yim

Open Access Study protocol

Accreditation in general practice in Denmark: study protocol for a cluster-randomized controlled trial

Merethe K. Andersen, Line B. Pedersen, Volkert Siersma, Flemming Bro, Susanne Reventlow, Jens Søndergaard, Marius Brostrøm Kousgaard, Frans B. Waldorff

Open Access Study protocol

A core outcome set for evaluating self-management interventions in people with comorbid diabetes and severe mental illness: study protocol for a modified Delphi study and systematic review

Johanna Taylor, Jan R. Böhnke, Judy Wright, Ian Kellar, Sarah L. Alderson, Tom Hughes, Richard I. G. Holt, Najma Siddiqi

Open Access Commentary

Challenges to complete and useful data sharing

Lawrence Mbuagbaw, Gary Foster, Ji Cheng, Lehana Thabane

Open Access Study protocol

Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: study protocol for a randomised controlled trial

Jodie Wiseman, Megan Simons, Roy Kimble, Robert Ware, Steven McPhail, Zephanie Tyack

Open Access Study protocol

Vascular Impulse Technology versus elevation in the treatment of posttraumatic swelling of extremity fractures: study protocol for a randomized controlled trial

Marc Schnetzke, Benedict Swartman, Isabel Bonnen, Holger Keil, Svenja Schüler, Paul A. Grützner, Jochen Franke

Open Access Erratum

Erratum to: The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for A three-year cluster randomized controlled trial

Elizabeth L. Turner, Siham Sikander, Omer Bangash, Ahmed Zaidi, Lisa Bates, John Gallis, Nima Ganga, Karen O’Donnell, Atif Rahman, Joanna Maselko

Open Access Study protocol

The KiVa antibullying program in primary schools in Chile, with and without the digital game component: study protocol for a randomized controlled trial

Jorge Gaete, Daniela Valenzuela, Cristian Rojas-Barahona, Eduardo Valenzuela, Ricardo Araya, Christina Salmivalli

Open Access Study protocol

Magnetic resonance imaging for cerebral lesions during minimal invasive mitral valve surgery: study protocol for a randomized controlled trial

Cristina Barbero, Davide Ricci, Erik Cura Stura, Augusto Pellegrini, Giovanni Marchetto, Suad ElQarra, Massimo Boffini, Roberto Passera, Maria Consuelo Valentini, Mauro Rinaldi

Open Access Study protocol

Use of activity tracking in major visceral surgery—the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial

Steffen Wolk, Theresa Meißner, Sebastian Linke, Benjamin Müssle, Ann Wierick, Andreas Bogner, Dorothée Sturm, Nuh N. Rahbari, Marius Distler, Jürgen Weitz, Thilo Welsch

Open Access Research

Sample size considerations for trials using cerebral white matter hyperintensity progression as an intermediate outcome at 1 year after mild stroke: results of a prospective cohort study

Francesca M. Chappell, Maria del Carmen Valdés Hernández, Stephen D. Makin, Kirsten Shuler, Eleni Sakka, Martin S. Dennis, Paul A. Armitage, Susana Muñoz Maniega, Joanna M. Wardlaw

Open Access Study protocol

Unravelling effectiveness of a nurse-led behaviour change intervention to enhance physical activity in patients at risk for cardiovascular disease in primary care: study protocol for a cluster randomised controlled trial

Heleen Westland, Irene D. Bos-Touwen, Jaap C. A. Trappenburg, Carin D. Schröder, Niek J. de Wit, Marieke J. Schuurmans

Open Access Study protocol

Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial

Chin Kook Rhee, Hye Yun Park, Jeong-Woong Park, Ji-Hyun Lee, Tae-Hyung Kim, Sei Won Lee, Ji Ye Jung, Song Kim, Yong Il Hwang, Ki-Suck Jung

Open Access Study protocol

The effect of MElatonin on Depressive symptoms, Anxiety, CIrcadian and Sleep disturbances in patients after acute coronary syndrome (MEDACIS): study protocol for a randomized controlled trial

Michael Tvilling Madsen, Anders Isbrand, Ulla Overgaard Andersen, Lars Juel Andersen, Mustafa Taskiran, Erik Simonsen, Ismail Gögenur

Open Access Study protocol

Effectiveness of telerehabilitation programme following surgery in shoulder impingement syndrome (SIS): study protocol for a randomized controlled non-inferiority trial

Jose-Manuel Pastora-Bernal, Rocío Martín-Valero, Francisco Javier Barón-López, Oscar García-Gómez

Open Access Study protocol

Electrical somatosensory stimulation followed by motor training of the paretic upper limb in acute stroke: study protocol for a randomized controlled trial

Emma Ghaziani, Christian Couppé, Cecilie Henkel, Volkert Siersma, Mette Søndergaard, Hanne Christensen, S. Peter Magnusson

Open Access Study protocol

Thromboelastometry versus standard coagulation tests versus restrictive protocol to guide blood transfusion prior to central venous catheterization in cirrhosis: study protocol for a randomized controlled trial

Leonardo Lima Rocha, Camila Menezes Souza Pessoa, Ary Serpa Neto, Rogerio Ruscitto do Prado, Eliezer Silva, Marcio Dias de Almeida, Thiago Domingos Correa

Open Access Commentary

Clinical trial registries: more international, converging efforts are needed

Claudia Pansieri, Chiara Pandolfini, Maurizio Bonati

Open Access Study protocol

TREatment of ATopic eczema (TREAT) Registry Taskforce: protocol for an international Delphi exercise to identify a core set of domains and domain items for national atopic eczema registries

Louise A. A. Gerbens, Aaron E. Boyce, Dmitri Wall, Sebastien Barbarot, Richard J. de Booij, Mette Deleuran, Maritza A. Middelkamp-Hup, Amanda Roberts, Christian Vestergaard, Stephan Weidinger, Christian J. Apfelbacher, Alan D. Irvine, Jochen Schmitt, Paula R. Williamson, Phyllis I. Spuls, Carsten Flohr

Open Access Study protocol

The effectiveness of Robot-Assisted Gait Training versus conventional therapy on mobility in severely disabled progressIve MultiplE sclerosis patients (RAGTIME): study protocol for a randomized controlled trial

Sofia Straudi, Fabio Manfredini, Nicola Lamberti, Paolo Zamboni, Francesco Bernardi, Giovanna Marchetti, Paolo Pinton, Massimo Bonora, Paola Secchiero, Veronica Tisato, Stefano Volpato, Nino Basaglia

Open Access Study protocol

Rigorous evaluation of a pregnancy prevention program for American Indian youth and adolescents: study protocol for a randomized controlled trial

Lauren Tingey, Rachel Chambers, Novalene Goklish, Francene Larzelere, Angelita Lee, Rosemarie Suttle, Summer Rosenstock, Kristin Lake, Allison Barlow

Open Access Study protocol

A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study)

Henrik Eshoj, Sten Rasmussen, Lars Henrik Frich, Inge Hvass, Robin Christensen, Steen Lund Jensen, Jens Søndergaard, Karen Søgaard, Birgit Juul-Kristensen

Open Access Study protocol

Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly (ReShAPE trial) : study protocol for a multicentre combined randomised controlled and observational trial

Geoffrey C. S. Smith, Ed Bateman, Ben Cass, Maurizio Damiani, Wade Harper, Hugh Jones, David Lieu, Jeff Petchell, Minas Petrelis, Kalman Piper, Doron Sher, Christopher J. Smithers, John Trantalis, Sindy Vrancic, Ian A. Harris

Open Access Study protocol

A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED): Study protocol for a randomised controlled trial

David Saxon, Kate Ashley, Lindsey Bishop-Edwards, Janice Connell, Phillippa Harrison, Sally Ohlsen, Gillian E. Hardy, Stephen Kellett, Clara Mukuria, Toni Mank, Peter Bower, Mike Bradburn, John Brazier, Robert Elliott, Lynne Gabriel, Michael King, Stephen Pilling, Sue Shaw, Glenn Waller, Michael Barkham

Open Access Erratum

Erratum to: START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a clusterrandomised controlled trial

Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine M. Freitag, Robert L. Trestman, Christina Stadler

Open Access Study protocol

A mobile technology intervention to reduce sedentary behaviour in 2- to 4-year-old children (Mini Movers): study protocol for a randomised controlled trial

Katherine L. Downing, Jo Salmon, Trina Hinkley, Jill A. Hnatiuk, Kylie D. Hesketh

Open Access Study protocol

Radiation-induced toxicity after image-guided and intensity-modulated radiotherapy versus external beam radiotherapy for patients with spinal bone metastases (IRON-1): a study protocol for a randomized controlled pilot trial

Eva Meyerhof, Tanja Sprave, Stefan Ezechiel Welte, Nils H. Nicolay, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Jürgen Debus, Harald Rief

Open Access Study protocol

Effectiveness of deep versus moderate muscle relaxation during laparoscopic donor nephrectomy in enhancing postoperative recovery: study protocol for a randomized controlled study

Moira H. D. Bruintjes, Andries E. Braat, Albert Dahan, Gert-Jan Scheffer, Luuk B. Hilbrands, Frank C. H. d’Ancona, Rogier A. R. T. Donders, Cornelis J. H. M. van Laarhoven, Michiel C. Warlé

Open Access Study protocol

School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial

Bente Storm Mowatt Haugland, Solfrid Raknes, Aashild Tellefsen Haaland, Gro Janne Wergeland, Jon Fauskanger Bjaastad, Valborg Baste, Joe Himle, Ron Rapee, Asle Hoffart

Open Access Methodology

Analysis of cluster randomised stepped wedge trials with repeated cross-sectional samples

Karla Hemming, Monica Taljaard, Andrew Forbes

Open Access Study protocol

Mobile Exergaming for Health—Effects of a serious game application for smartphones on physical activity and exercise adherence in type 2 diabetes mellitus—study protocol for a randomized controlled trial

Christoph Höchsmann, Steffen P. Walz, Juliane Schäfer, Jussi Holopainen, Henner Hanssen, Arno Schmidt-Trucksäss

Open Access Study protocol

Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial)

Thomas Cayton, Amy E. Harwood, George E. Smith, Joshua P. Totty, Daniel Carradice, Ian C. Chetter

Open Access Research

The feasibility of the Prostate cancer: Evidence of Exercise and Nutrition Trial (PrEvENT) dietary and physical activity modifications: a qualitative study

Ellie Shingler, Lucy Hackshaw-McGeagh, Luke Robles, Raj Persad, Anthony Koupparis, Edward Rowe, Constance Shiridzinomwa, Amit Bahl, Richard M. Martin, J. Athene Lane

Open Access Review

Methods of defining the non-inferiority margin in randomized, double-blind controlled trials: a systematic review

Turki A. Althunian, Anthonius de Boer, Olaf H. Klungel, Widya N. Insani, Rolf H. H. Groenwold

Open Access Study protocol

First-in-man mesenchymal stem cells for radiation-induced xerostomia (MESRIX): study protocol for a randomized controlled trial

Christian Grønhøj, David H. Jensen, Peter V. Glovinski, Siri Beier Jensen, Allan Bardow, Roberto S. Oliveri, Lena Specht, Carsten Thomsen, Sune Darkner, Katalin Kiss, Anne Fischer-Nielsen, Christian von Buchwald

Open Access Study protocol

Randomized trial of acupressure to improve patient satisfaction and quality of recovery in hospitalized patients: study protocol for a randomized controlled trial

Eric Noll, Shivam Shodhan, Maria Cecilia Madariaga, Christopher R. Page, Diane Santangelo, Xiaojun Guo, Ehab Al Bizri, Aurora D. Pryor, Jamie Romeiser, Elliott Bennett-Guerrero

Open Access Study protocol

Tropomyosin Receptor Antagonism in Cylindromatosis (TRAC), an early phase trial of a topical tropomyosin kinase inhibitor as a treatment for inherited CYLD defective skin tumours: study protocol for a randomised controlled trial

Amy Cranston, Deborah D. Stocken, Elaine Stamp, David Roblin, Julia Hamlin, James Langtry, Ruth Plummer, Alan Ashworth, John Burn, Neil Rajan

Open Access Study protocol

Rituximab versus azathioprine as therapy for maintenance of remission for anti-neutrophil cytoplasm antibody-associated vasculitis (RITAZAREM): study protocol for a randomized controlled trial

Seerapani Gopaluni, Rona M. Smith, Michelle Lewin, Carol A. McAlear, Kim Mynard, Rachel B. Jones, Ulrich Specks, Peter A. Merkel, David R. W. Jayne

Open Access Erratum

Erratum to: Optimizing adalimumab treatment in psoriasis with concomitant methotrexate (OPTIMAP): study protocol for a pragmatic, single-blinded, investigator-initiated randomized controlled trial

Celine Busard, Stef Menting, SJ van Bezooijen, Juul van den Reek, Barbara Hutten, Errol Prens, Elke de Jong, Martijn van Doorn, Phyllis Spuls

Open Access Study protocol

Acute effects of foam rolling on passive tissue stiffness and fascial sliding: study protocol for a randomized controlled trial

Frieder Krause, Jan Wilke, Daniel Niederer, Lutz Vogt, Winfried Banzer

Open Access Study protocol

Acupuncture treatment for insulin sensitivity of women with polycystic ovary syndrome and insulin resistance: a study protocol for a randomized controlled trial

Juan Li, Ernest Hung Yu Ng, Elisabet Stener-Victorin, Zhenxing Hu, Xiaoguang Shao, Haiyan Wang, Meifang Li, Maohua Lai, Changcai Xie, Nianjun Su, Chuyi Yu, Jia Liu, Taixiang Wu, Hongxia Ma

Open Access Study protocol

Treatment with L-citrulline in patients with post-polio syndrome: study protocol for a single-center, randomised, placebo-controlled, double-blind trial

Simone Schmidt, Vanya Gocheva, Thomas Zumbrunn, Daniela Rubino-Nacht, Ulrike Bonati, Dirk Fischer, Patricia Hafner

Open Access Research

The use of randomisation-based efficacy estimators in non-inferiority trials

David Gillespie, Daniel Farewell, Peter Barrett-Lee, Angela Casbard, Anthony Barney Hawthorne, Chris Hurt, Nick Murray, Chris Probert, Rachel Stenson, Kerenza Hood

Open Access Study protocol

The Benefits of Early Book Sharing (BEBS) for child cognitive and socio-emotional development in South Africa: study protocol for a randomised controlled trial

Nicholas Dowdall, Peter J. Cooper, Mark Tomlinson, Sarah Skeen, Frances Gardner, Lynne Murray

Open Access Research

Preventing recurrence of endometriosis by means of long-acting progestogen therapy (PRE-EMPT): report of an internal pilot, multi-arm, randomised controlled trial incorporating flexible entry design and adaption of design based on feasibility of recruitment

Lee J. Middleton, Jane P. Daniels, Annalise Weckesser, Siladitya Bhattacharya, Tracy Roberts, Hilary O. D. Critchley, Christian Becker, Kevin Cooper, Janesh Gupta, Ertan Saridogan, Andrew Horne, Justin Clark, Andrew Prentice, Georgina Jones, Elaine Denny, Catherine Whittall

Open Access Commentary

Why clinical trial outcomes fail to translate into benefits for patients

Carl Heneghan, Ben Goldacre, Kamal R. Mahtani

Open Access Study protocol

Addition of Propranolol in Resistant Arterial hypertension Treatment (APROPRIATE study): study protocol for a randomized double-blind placebo-controlled trial

G. R. Constantine, P. Ranasinghe, P. Weeratunga, C. Weeraratne, P. Galappatthy, S. Rajapakse, U. Senarath, P. Katulanda

Open Access Study protocol

The Ghent Psychotherapy Study (GPS) on the differential efficacy of supportive-expressive and cognitive behavioral interventions in dependent and self-critical depressive patients: study protocol for a randomized controlled trial

Reitske Meganck, Mattias Desmet, Claudi Bockting, Ruth Inslegers, Femke Truijens, Melissa De Smet, Rosa De Geest, Kimberly Van Nieuwenhove, Vicky Hennissen, Goedele Hermans, Tom Loeys, Ufuoma Angelica Norman, Chris Baeken, Stijn Vanheule

Open Access Study protocol

Frailty Related to Anesthesia guided by the Index “bispectraL” (FRAIL) study: study protocol for a randomized controlled trial

Morgan Le Guen, Marie Herr, Antoine Bizard, Caroline Bichon, Nathalie Boichut, Thierry Chazot, Ngai Liu, Joel Ankri, Marc Fischler

Open Access Study protocol

A prospective, randomised, placebo-controlled, double-masked, three-armed, multicentre phase II/III trial for the Study of a Topical Treatment of Ischaemic Central Retinal Vein Occlusion to Prevent Neovascular Glaucoma – the STRONG study: study protocol for a randomised controlled trial

Katrin Lorenz, Yvonne Scheller, Katharina Bell, Franz Grus, Katharina A. Ponto, Felix Bock, Claus Cursiefen, Jens Flach, Marta Gehring, Tunde Peto, Rufino Silva, Yossi Tal, Norbert Pfeiffer

Open Access Study protocol

Balanced crystalloids versus saline in the intensive care unit: study protocol for a cluster-randomized, multiple-crossover trial

Matthew W. Semler, Wesley H. Self, Li Wang, Daniel W. Byrne, Jonathan P. Wanderer, Jesse M. Ehrenfeld, Joanna L. Stollings, Avinash B. Kumar, Antonio Hernandez, Oscar D. Guillamondegui, Addison K. May, Edward D. Siew, Andrew D. Shaw, Gordon R. Bernard, Todd W. Rice, Gordon R. Bernard, Jonathan D. Casey, Matthew W. Semler, Michael J. Noto, Todd W. Rice, Daniel W. Byrne, Henry J. Domenico, Li Wang, Jesse M. Ehrenfeld, Jonathan P. Wanderer, Andrew D. Shaw, Antonio Hernandez, Avinash B. Kumar, Christopher G. Hughes, Emily Holcombe, Jayme Gibson, Lisa Weavind, Mias Pretorius, William T. Costello, Wesley H. Self, Edward D. Siew, Debra F. Dunlap, Joanna L. Stollings, Kelli A. Rumbaugh, Leanne Atchison, Mark Sullivan, Matthew Felbinger, Molly Knostman, Susan E. Hamblin, Addison K. May, Jason B. Young, Julie Y. Valenzuela, Oscar D. Guillamondegui, David P. Mulherin, Fred R. Hargrove, Seth Strawbridge

Open Access Study protocol

Laser peripheral iridotomy versus laser peripheral iridotomy plus laser peripheral iridoplasty in the treatment of multi-mechanism angle closure: study protocol for a randomized controlled trial

Shida Chen, Jianhua Lv, Sujie Fan, Hong Zhang, Lin Xie, Ling Xu, Bing Jiang, Huipin Yuan, Yuanbo Liang, Shuning Li, Pingyan Chen, Xiulan Zhang, Ningli Wang

Open Access Study protocol

Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health (“NiPPeR”): study protocol for a randomised controlled trial

Keith M. Godfrey, Wayne Cutfield, Shiao-Yng Chan, Philip N. Baker, Yap-Seng Chong, Izzuddin Bin Mohamad Aris, Sheila J. Barton, Jonathan Y. Bernard, Veronica Boyle, Graham C. Burdge, Christopher D. Byrne, Shirong Cai, Philip C. Calder, Claudia Chi, Caroline E. Childs, Mary F. Chong, Cathryn Conlon, Cyrus Cooper, Marilou Ebreo, Sarah El-Heis, Marielle Fortier, Lisa R. Fries, Nicholas C. Harvey, Joanna D. Holbrook, Richard Holt, Hazel M. Inskip, Neerja Karnani, Timothy Kenealy, Yung Seng Lee, Karen Lillycrop, See Ling Loy, Katherine Macé, Pamela A. Mahon, Min Gong, Falk Müller-Riemenschneider, Sharon Ng, Heidi Nield, Justin M. O’Sullivan, Wei Wei Pang, Charles Peebles, Anne Rifkin-Graboi, Lesley McCowan, Allan Sheppard, Nick Macklon, Tinu Mary Samuel, Shu E. Soh, Lynette Pei-Chi Shek, Irma Silva-Zolezzi, Rachael Taylor, Sagar K. Thakkar, Mya Thway Tint, Clare Wall, Wei Ying

Open Access Study protocol

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2) photographic validation sub-study: study protocol for a randomised controlled trial

Elizabeth McGinnis, Sarah Brown, Howard Collier, Phil Faulks, Rachael Gilberts, Clare Greenwood, Valerie Henderson, Delia Muir, Andrea Nelson, Jane Nixon, Isabelle Smith, Nikki Stubbs, Kay Walker, Lyn Wilson, Susanne Coleman

Open Access Commentary

The possibility of critical realist randomised controlled trials

Sam Porter, Tracey McConnell, Joanne Reid

Open Access Study protocol

Does rating the operation videos with a checklist score improve the effect of E-learning for bariatric surgical training? Study protocol for a randomized controlled trial

Javier Rodrigo De La Garza, Karl-Friedrich Kowalewski, Mirco Friedrich, Mona Wanda Schmidt, Thomas Bruckner, Hannes Götz Kenngott, Lars Fischer, Beat-Peter Müller-Stich, Felix Nickel

Open Access Study protocol

Effect of Guizhifulingwan (Keishibukuryogan) on climacteric syndrome: study protocol for a randomized controlled pilot trial

Jung-Eun Kim, Junghyo Cho, Ojin Kwon, Ae-Ran Kim, Hyo-Ju Park, So-Young Jung, Joo-Hee Kim, Mikyung Kim, Hye-Yoon Lee, Jun-Hwan Lee

Open Access Study protocol

Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT): the role of anti-IgE in severe paediatric eczema: study protocol for a randomised controlled trial

Susan Chan, Victoria Cornelius, Tao Chen, Suzana Radulovic, Mandy Wan, Rahi Jahan, Gideon Lack

Open Access Research

Poor uptake of an online intervention in a cluster randomised controlled trial of online diabetes education for rural general practitioners

Christine L. Paul, Leon Piterman, Jonathan E. Shaw, Catherine Kirby, Kristy L. Forshaw, Jennifer Robinson, Isaraporn Thepwongsa, Robert W. Sanson-Fisher

Open Access Erratum

Erratum to: Cognitive rehabiliation for Parkinson’s disease dementia: a study protocol for a pilot randomised controlled trial

John V. Hindle, Tamlyn J. Watermeyer, Julie Roberts, Anthony Martyr, Huw Lloyd-Williams, Andrew Brand, Petra Gutting, Zoe Hoare, Rhiannon Tudor Edwards, Linda Clare

Open Access Study protocol

Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: study protocol for a randomised controlled trial

Christine Norton, Anton Emmanuel, Natasha Stevens, S. Mark Scott, Ugo Grossi, Sybil Bannister, Sandra Eldridge, James M. Mason, Charles H. Knowles

Open Access Research

Equipoise across the patient population: optimising recruitment to a randomised controlled trial

Paul Whybrow, Robert Pickard, Susan Hrisos, Tim Rapley

Open Access Study protocol

Efficacy of orally administered prednisolone versus partial endodontic treatment on pain reduction in emergency care of acute irreversible pulpitis of mandibular molars: study protocol for a randomized controlled trial

Olivia Kérourédan, Léonard Jallon, Paul Perez, Christine Germain, Jean-François Péli, Dominique Oriez, Jean-Christophe Fricain, Elise Arrivé, Raphaël Devillard

Open Access Study protocol

Cognitive-behavioral rehabilitation vs. treatment as usual for bipolar patients: study protocol for a randomized controlled trial

Bernardo Carramão Gomes, Cristiana Castanho Rocca, Gabriel Okawa Belizario, Beny Lafer

Open Access Commentary

Why prudence is needed when interpreting articles reporting clinical trial results in mental health

Rafael Dal-Ré, Julio Bobes, Pim Cuijpers

Open Access Research

An optimised patient information sheet did not significantly increase recruitment or retention in a falls prevention study: an embedded randomised recruitment trial

Sarah Cockayne, Caroline Fairhurst, Joy Adamson, Catherine Hewitt, Robin Hull, Kate Hicks, Anne-Maree Keenan, Sarah E. Lamb, Lorraine Green, Caroline McIntosh, Hylton B. Menz, Anthony C. Redmond, Sara Rodgers, David J. Torgerson, Wesley Vernon, Judith Watson, Peter Knapp, Jo Rick, Peter Bower, Sandra Eldridge, Vichithranie W. Madurasinghe, Jonathan Graffy

Open Access Study protocol

Effect of Pycnogenol® on attention-deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial

Annelies A. J. Verlaet, Berten Ceulemans, Helene Verhelst, Dirk Van West, Tess De Bruyne, Luc Pieters, Huub F. J. Savelkoul, Nina Hermans

Open Access Study protocol

Efficacy and safety of rapid intermittent correction compared with slow continuous correction with hypertonic saline in patients with moderately severe or severe symptomatic hyponatremia: study protocol for a randomized controlled trial (SALSA trial)

Anna Lee, You Hwan Jo, Kyuseok Kim, Soyeon Ahn, Yun Kyu Oh, Huijai Lee, Jonghwan Shin, Ho Jun Chin, Ki Young Na, Jung Bok Lee, Seon Ha Baek, Sejoong Kim

Open Access Study protocol

Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER — Abdominal Massage for Bowel Dysfunction Effectiveness Research): study protocol for a randomised controlled trial

Doreen McClurg, Kirsteen Goodman, Suzanne Hagen, Fional Harris, Sean Treweek, Anton Emmanuel, Christine Norton, Maureen Coggrave, Selina Doran, John Norrie, Peter Donnan, Helen Mason, Sarkis Manoukian

Open Access Study protocol

Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial

Christopher Emmett, Helen Close, James Mason, Shiva Taheri, Natasha Stevens, Sandra Eldridge, Christine Norton, Charles Knowles, Yan Yiannakou

Open Access Study protocol

Early versus late BCG vaccination in HIV-1-exposed infants in Uganda: study protocol for a randomized controlled trial

Victoria Nankabirwa, James K. Tumwine, Olive Namugga, Thorkild Tylleskär, Grace Ndeezi, Bjarne Robberstad, Mihai G. Netea, Halvor Sommerfelt

Open Access Study protocol

Measuring the impact of ambulatory red blood cell transfusion on home functional status: study protocol for a pilot randomized controlled trial

Dennis H. Murphree, Theresa N. Kinard, Nandita Khera, Curtis B. Storlie, Che Ngufor, Sudhindra Upadhyaya, Jyotishman Pathak, Emma Fortune, Eapen K. Jacob, Rickey E. Carter, Karl A. Poterack, Daryl J. Kor

Open Access Research

Alcohol-free essential oils containing mouthrinse efficacy on three-day supragingival plaque regrowth: a randomized crossover clinical trial

Enrico Marchetti, Simona Tecco, Eleonora Caterini, Fabio Casalena, Vincenzo Quinzi, Antonella Mattei, Giuseppe Marzo

Open Access Study protocol

Differentiated resistance training of the paravertebral muscles in patients with unstable spinal bone metastasis under concomitant radiotherapy: study protocol for a randomized pilot trial

Stefan Ezechiel Welte, Joachim Wiskemann, Friederike Scharhag-Rosenberger, Robert Förster, Tilman Bostel, Thomas Bruckner, Ingmar Schlampp, Eva Meyerhof, Tanja Sprave, Nils H. Nicolay, Jürgen Debus, Harald Rief

Open Access Study protocol

Short message service (SMS)-based intervention targeting alcohol consumption among university students: study protocol of a randomized controlled trial

Kristin Thomas, Marcus Bendtsen, Catharina Linderoth, Nadine Karlsson, Preben Bendtsen, Ulrika Müssener

Open Access Study protocol

The effect of a clinical decision-making mHealth support system on maternal and neonatal mortality and morbidity in Ghana: study protocol for a cluster randomized controlled trial

Hannah Brown Amoakoh, Kerstin Klipstein-Grobusch, Mary Amoakoh-Coleman, Irene Akua Agyepong, Gbenga A. Kayode, Charity Sarpong, Diederick E. Grobbee, Evelyn K. Ansah

Open Access Study protocol

A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial

Amy McAndrew, Will Lawn, Tobias Stevens, Lilla Porffy, Brigitta Brandner, Celia J. A. Morgan

Open Access Study protocol

Eye movement desensitization and reprocessing therapy versus supportive therapy in affective relapse prevention in bipolar patients with a history of trauma: study protocol for a randomized controlled trial

Ana Moreno-Alcázar, Joaquim Radua, Ramon Landín-Romero, Laura Blanco, Mercè Madre, Maria Reinares, Mercè Comes, Esther Jiménez, Jose Manuel Crespo, Eduard Vieta, Victor Pérez, Patricia Novo, Marta Doñate, Romina Cortizo, Alicia Valiente-Gómez, Walter Lupo, Peter J. McKenna, Edith Pomarol-Clotet, Benedikt L. Amann

Open Access Study protocol

Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study

Daniel Glinatsi, Marte S. Heiberg, Anna Rudin, Dan Nordström, Espen A. Haavardsholm, Bjorn Gudbjornsson, Mikkel Østergaard, Till Uhlig, Gerdur Grondal, Kim Hørslev-Petersen, Ronald van Vollenhoven, Merete L. Hetland

Open Access Research

Reasons for non-recruitment of eligible patients to a randomised controlled trial of secondary prevention after intracerebral haemorrhage: observational study

Amy E. Maxwell, Mary Joan MacLeod, Anu Joyson, Sharon Johnson, Hawraman Ramadan, Ruth Bellfield, Anthony Byrne, Caroline McGhee, Anthony Rudd, Fiona Price, Evangelos Vasileiadis, Melinda Holden, Jonathan Hewitt, Michael Carpenter, Ann Needle, Stacey Valentine, Farzana Patel, Frances Harrington, Paul Mudd, Hedley Emsley, Bindu Gregary, Ingrid Kane, Keith Muir, Divya Tiwari, Peter Owusu-Agyei, Natalie Temple, Lakshmanan Sekaran, Suzanne Ragab, Timothy England, Amanda Hedstrom, Phil Jones, Sarah Jones, Mandy Doherty, Mark O. McCarron, David L. Cohen, Sharon Tysoe, Rustam Al-Shahi Salman

Open Access Research

The pancreatic surgery registry (StuDoQ|Pancreas) of the German Society for General and Visceral Surgery (DGAV) – presentation and systematic quality evaluation

Ulrich F. Wellner, Carsten Klinger, Kai Lehmann, Heinz Buhr, Edmund Neugebauer, Tobias Keck

Open Access Erratum

Erratum to: Measurement of HbA1c in multicentre diabetes trials – should blood samples be tested locally or sent to a central laboratory: an agreement analysis

Barbara N. Arch, Joanne Blair, Andrew McKay, John W. Gregory, Paul Newland, Carrol Gamble

Open Access Study protocol

The efficacy of sodium benzoate as an adjunctive treatment in early psychosis - CADENCE-BZ: study protocol for a randomized controlled trial

Alex Ryan, Andrea Baker, Frances Dark, Sharon Foley, Anne Gordon, Sean Hatherill, Stephen Stathis, Sukanta Saha, George Bruxner, Martin Beckman, Drew Richardson, Michael Berk, Olivia Dean, John McGrath, Cadence Working Group, James Scott

Open Access Study protocol

Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial

Thijs de Rooij, Jony van Hilst, Jantien A. Vogel, Hjalmar C. van Santvoort, Marieke T. de Boer, Djamila Boerma, Peter B. van den Boezem, Bert A. Bonsing, Koop Bosscha, Peter-Paul Coene, Freek Daams, Ronald M. van Dam, Marcel G. Dijkgraaf, Casper H. van Eijck, Sebastiaan Festen, Michael F. Gerhards, Bas Groot Koerkamp, Jeroen Hagendoorn, Erwin van der Harst, Ignace H. de Hingh, Cees H. Dejong, Geert Kazemier, Joost Klaase, Ruben H. de Kleine, Cornelis J. van Laarhoven, Daan J. Lips, Misha D. Luyer, I. Quintus Molenaar, Vincent B. Nieuwenhuijs, Gijs A. Patijn, Daphne Roos, Joris J. Scheepers, George P. van der Schelling, Pascal Steenvoorde, Rutger-Jan Swijnenburg, Jan H. Wijsman, Moh’d Abu Hilal, Olivier R. Busch, Marc G. Besselink

Open Access Study protocol

ForgIng New paths in DIabetes PrevenTion (FINDIT): Study Protocol for a Randomized Controlled Trial

Jeffrey T. Kullgren, Bradley Youles, Shaina Shetty, Caroline Richardson, Angela Fagerlin, Michele Heisler

Open Access Study protocol

Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial

Priya Morjaria, Andrew Bastawrous, Gudlavalleti Venkata Satyanarayana Murthy, Jennifer Evans, Clare Gilbert

Open Access Methodology

Advancing engagement methods for trials: the CORE study relational model of engagement for a stepped wedge cluster randomised controlled trial of experience-based co-design for people living with severe mental illnesses

Lauralie Richard, Donella Piper, Wayne Weavell, Rosemary Callander, Rick Iedema, John Furler, David Pierce, Kali Godbee, Jane Gunn, Victoria J. Palmer

Open Access Study protocol

Abelmoschus manihot – a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial

Ping Li, Yi-zhi Chen, Hong-li Lin, Zhao-hui Ni, Yong-li Zhan, Rong Wang, Hong-tao Yang, Jing-ai Fang, Nian-song Wang, Wen-ge Li, Xue-feng Sun, Xiang-mei Chen

Open Access Study protocol

MYPLAN –mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial

Kate Andreasson, Jesper Krogh, Per Bech, Hanne Frandsen, Niels Buus, Barbara Stanley, Ad Kerkhof, Merete Nordentoft, Annette Erlangsen

Open Access Study protocol

Intranasal sedation using ketamine and midazolam for pediatric dental treatment (NASO): study protocol for a randomized controlled trial

Heloisa Sousa Gomes, Analya Rodrigues Miranda, Karolline Alves Viana, Aline Carvalho Batista, Paulo Sucasas Costa, Anelise Daher, Geovanna de Castro Morais Machado, Joji Sado-Filho, Liliani Aires Candido Vieira, Patrícia Corrêa-Faria, Marie Therese Hosey, Luciane Rezende Costa

Open Access Study protocol

Prospective clinical study of rehabilitation interventions with multisensory interactive training in patients with cerebral infarction: study protocol for a randomised controlled trial

Wai Leung Ambrose Lo, Yu Rong Mao, Le Li, Ai Hua Lin, Jiang Li Zhao, Ling Chen, Qiang Lin, Hai Li, Dong Feng Huang

Open Access Study protocol

PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: study protocol for a randomized controlled trial

Elodie Crétel-Durand, Emilie Nouguerède, Hervé Le Caer, Frédérique Rousseau, Frédérique Retornaz, Olivier Guillem, Anne-Laure Couderc, Laurent Greillier, Emmanuelle Norguet, Maud Cécile, Rabia Boulahssass, Francoise Le Caer, Sandrine Tournier, Chantal Butaud, Pierre Guillet, Sophie Nahon, Laure Poudens, Sylvie Kirscher, Sandrine Loubière, Nadine Diaz, Jean Dhorne, Pascal Auquier, Karine Baumstarck

Open Access Research

Development of a core outcome set for effectiveness trials aimed at optimising prescribing in older adults in care homes

Anna N. Millar, Amrit Daffu-O’Reilly, Carmel M. Hughes, David P. Alldred, Garry Barton, Christine M. Bond, James A. Desborough, Phyo K. Myint, Richard Holland, Fiona M. Poland, David Wright, Annie Blyth, Kate Massey, Vivienne Maskrey, Clare Symms, Arnold Zermansky

Open Access Study protocol

Topical application of Jaungo in atopic dermatitis patients: study protocol for a randomized, controlled trial

Younghee Yun, Youme Ko, Jin-Hyang Ahn, Bo-Hyoung Jang, Kyuseok Kim, Seong-Gyu Ko, Inhwa Choi

Open Access Study protocol

Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial

Sung-Phil Kim, Joo-Hee Kim, Bo-Kyung Kim, Hyeong-Jun Kim, In Chul Jung, Jung Hyo Cho, Jung-Eun Kim, Mi-Kyung Kim, O-Jin Kwon, Ae-Ran Kim, Hyo-Ju Park, Bok-Nam Seo

Open Access Study protocol

Saline versus balanced crystalloids for intravenous fluid therapy in the emergency department: study protocol for a cluster-randomized, multiple-crossover trial

Wesley H. Self, Matthew W. Semler, Jonathan P. Wanderer, Jesse M. Ehrenfeld, Daniel W. Byrne, Li Wang, Leanne Atchison, Matthew Felbinger, Ian D. Jones, Stephan Russ, Andrew D. Shaw, Gordon R. Bernard, Todd W. Rice

Open Access Research

Do images of a personalised future body shape help with weight loss? A randomised controlled study

Gemma Ossolinski, Moyez Jiwa, Alexandra McManus, Richard Parsons

Open Access Study protocol

Optimizing veteran-centered prostate cancer survivorship care: study protocol for a randomized controlled trial

Ted A. Skolarus, Tabitha Metreger, Soohyun Hwang, Hyungjin Myra Kim, Robert L. Grubb III, Jeffrey R. Gingrich, Sarah T. Hawley

Open Access Study protocol

Research Exploring Physical Activity in Care Homes (REACH): study protocol for a randomised controlled trial

Anne Forster, Jennifer Airlie, Karen Birch, Robert Cicero, Bonnie Cundill, Alison Ellwood, Mary Godfrey, Liz Graham, John Green, Claire Hulme, Rebecca Lawton, Vicki McLellan, Nicola McMaster, Amanda Farrin, Anne Forster, Karen Birch, David R. Ellard, Amanda Farrin, Joan Firth, Beverley Gallagher, Mary Godfrey, Liz Graham, John Green, Rebecca Hawkins, Claire Hulme, Rebecca Lawton, Najma Siddiqi, John Young

Open Access Study protocol

A multicenter randomized controlled trial of surgery alone or surgery with atrial natriuretic peptide in lung cancer surgery: study protocol for a randomized controlled trial

Takashi Nojiri, Haruko Yamamoto, Toshimitsu Hamasaki, Kaori Onda, Kikuko Ohshima, Yasushi Shintani, Meinoshin Okumura, Kenji Kangawa, Meinoshin Okumura, Jun Nakajima, Masahiro Tsuboi, Yasuhiro Hida, Yoshimasa Maniwa, Hiroyuki Oizumi, Masahiko Higashiyama, Yukiyasu Takeuchi, Yoshihisa Kadota, Satoshi Shiono

Open Access Study protocol

Optimising conservative management of chronic low back pain: study protocol for a randomised controlled trial

Katherine J. Simson, Clint T. Miller, Jon Ford, Andrew Hahne, Luana Main, Timo Rantalainen, Wei-Peng Teo, Megan Teychenne, David Connell, Guy Trudel, Guoyan Zheng, Gary Thickbroom, Daniel L. Belavy

Open Access Study protocol

Effect of acupuncture in prevention and treatment of chemotherapy-induced nausea and vomiting in patients with advanced cancer: study protocol for a randomized controlled trial

Qi-wei Li, Ming-wei Yu, Guo-wang Yang, Xiao-min Wang, Huan Wang, Chen-xi Zhang, Na Xue, Wei-ru Xu, Qi Fu, Zhong Yang, Lin Yang

Open Access Study protocol

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial

Eldré W. Beukes, David M. Baguley, Peter M. Allen, Vinaya Manchaiah, Gerhard Andersson

Open Access Study protocol

The effect of vitamin B12 supplementation in Nepalese infants on growth and development: study protocol for a randomized controlled trial

Tor A. Strand, Manjeswori Ulak, Ram K. Chandyo, Ingrid Kvestad, Mari Hysing, Merina Shrestha, Sudha Basnet, Suman Ranjitkar, Laxman Shrestha, Prakash S. Shrestha

Open Access Study protocol

Comparison of the efficacy between conventional moxibustion and smoke-free moxibustion on knee osteoarthritis: study protocol of a randomized controlled trial

Lin-lin Zhu, Jian-ying Zhou, Ling Luo, Xiang Wang, Jia-xi Peng, Sha-sha Chen, Hai-Yan Yin, Qiao-Feng Wu, Cheng-shun Zhang, Peng Lv, Yong Tang, Shu-guang Yu

Open Access Study protocol

Forced fluid removal versus usual care in intensive care patients with high-risk acute kidney injury and severe fluid overload (FFAKI): study protocol for a randomised controlled pilot trial

Rasmus E. Berthelsen, Theis Itenov, Anders Perner, Jens-Ulrik Jensen, Michael Ibsen, Andreas Emil Kryger Jensen, Morten Bestle

Open Access Study protocol

Evaluating effectiveness and cost-effectiveness of a group psychological intervention using cognitive behavioural strategies for women with common mental disorders in conflict-affected rural Pakistan: study protocol for a randomised controlled trial

Anna Chiumento, Syed Usman Hamdani, Muhammad Naseem Khan, Katie Dawson, Richard A. Bryant, Marit Sijbrandij, Huma Nazir, Parveen Akhtar, Aqsa Masood, Duolao Wang, Mark van Ommeren, Atif Rahman

Open Access Study protocol

Metformin to Augment Strength Training Effective Response in Seniors (MASTERS): study protocol for a randomized controlled trial

Doug E. Long, Bailey D. Peck, Jenny L. Martz, S. Craig Tuggle, Heather M. Bush, Gerald McGwin, Philip A. Kern, Marcas M. Bamman, Charlotte A. Peterson

Open Access Erratum

Erratum to: The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial

U. Teichgräber, R. Aschenbach, D. Scheinert, T. Zeller, K. Brechtel, M. Thieme, E. Blessing, M. Treitl, M. Lichtenberg, P. von Flotow, B. Vogel, M. Werk, V. Riambau, A. Wienke, T. Lehmann, S. Sixt

Open Access Study protocol

The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial

Willem Kuyken, Elizabeth Nuthall, Sarah Byford, Catherine Crane, Tim Dalgleish, Tamsin Ford, Mark T. Greenberg, Obioha C. Ukoumunne, Russell M. Viner, J. Mark G. Williams, Daniel Brett, Liz Lord, Lucy Palmer, Anna Sonley, Laura Taylor, Anam Raja, Triona Casey

Open Access Study protocol

Ketogenic diet in the treatment of epilepsy in children under the age of 2 years: study protocol for a randomised controlled trial

Siobhan Titre-Johnson, Natasha Schoeler, Christin Eltze, Ruth Williams, Katharina Vezyroglou, Helen McCullagh, Nick Freemantle, Simon Heales, Rachel Kneen, Louise Marston, Tim Martland, Irwin Nazareth, Elizabeth Neal, Andrew Lux, Alasdair Parker, Shakti Agrawal, Penny Fallon, J. Helen Cross

Open Access Research

Clinicians’ views and experiences of offering two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

Celine Y. Chhoa, Alexandra Sawyer, Susan Ayers, Angela Pushpa-Rajah, Lelia Duley

Open Access Study protocol

Case Method in COPD education for primary care physicians: study protocol for a cluster randomised controlled trial

Hanna Sandelowsky, Ingvar Krakau, Sonja Modin, Björn Ställberg, Anna Nager

Open Access Study protocol

Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis (the SIMPLE trial): study protocol for a randomised controlled trial

Shannon E. Munteanu, Karl B. Landorf, Jodie A. McClelland, Edward Roddy, Flavia M. Cicuttini, Alan Shiell, Maria Auhl, Jamie J. Allan, Andrew K. Buldt, Hylton B. Menz

Open Access Study protocol

Lymphoma InterVEntion (LIVE) – patient-reported outcome feedback and a web-based self-management intervention for patients with lymphoma: study protocol for a randomised controlled trial

Lindy P. J. Arts, Lonneke V. van de Poll-Franse, Sanne W. van den Berg, Judith B. Prins, Olga Husson, Floortje Mols, Angelique V. M. Brands-Nijenhuis, Lidwine Tick, Simone Oerlemans

Open Access Study protocol

Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial

Dina Visca, Vicky Tsipouri, Letizia Mori, Ashi Firouzi, Sharon Fleming, Morag Farquhar, Elizabeth Leung, Toby M. Maher, Paul Cullinan, Nick Hopkinson, Athol U. Wells, Winston Banya, Jennifer A. Whitty, Huzaifa Adamali, Lisa G. Spencer, Piersante Sestini, Elisabetta A. Renzoni

Open Access Study protocol

Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

T. Bluth, R. Teichmann, T. Kiss, I. Bobek, J. Canet, G. Cinnella, L. De Baerdemaeker, C. Gregoretti, G. Hedenstierna, S. N. Hemmes, M. Hiesmayr, M. W. Hollmann, S. Jaber, J. G. Laffey, M. J. Licker, K. Markstaller, I. Matot, G. Müller, G. H. Mills, J. P. Mulier, C. Putensen, R. Rossaint, J. Schmitt, M. Senturk, A. Serpa Neto, P. Severgnini, J. Sprung, M. F. Vidal Melo, H. Wrigge, M. J. Schultz, P. Pelosi, M. Gama de Abreu, Andreas Güldner, Robert Huhle, Christopher Uhlig, Luigi Vivona, Alice Bergamaschi, Rolf Rossaint, Ana Stevanovic, Tanja Treschan, Maximilian Schaefer, Peter Kienbaum, Rita Laufenberg-Feldmann, Lars Bergmann, Felix Ebner, Luisa Robitzky, Patrick Mölders, Matthias Unterberg, Cornelius Busch, Marc Achilles, Angelika Menzen, Harbert Freesemann, Christian Putensen, Humberto Machado, Carla Cavaleiro, Cristina Ferreira, Daniela Pinho, Marta Carvalho, Sílvia Pinho, Maria Soares, Diogo Sousa Castro, Fernando Abelha, Rui Rabico, Ellise Delphin, Juraj Sprung, Toby N. Weingarten, Todd A. Kellogg, Yvette N. Martin, Travis J. McKenzie, Sorin J. Brull, J. Ross Renew, Harish Ramakrishna, Ana Fernandez-Bustamante, Konstantin Balonov, Harris R. Baig, Aalok Kacha, Juan C. Pedemonte, Fernando Altermatt, Marcia A. Corvetto, Sebastian Paredes, Javiera Carmona, Augusto Rolle, Elke Bos, Charlotte Beurskens, B. Veering, Harry Zonneveldt, Christa Boer, Marc Godfried, Bram Thiel, Barbara Kabon, Christian Reiterer, Jaume Canet, Raquel Tolós, Mar Sendra, Miriam González, Noemí Gómez, Carlos Ferrando, Tania Socorro, Ana Izquierdo, Marina Soro, Manuel Granell Gil, María José Hernández Cádiz, Elena Biosca Pérez, Alejandro Suarez-de-la-Rica, Mercedes Lopez-Martinez, Iván Huercio, Emilio Maseda, Julio Yagüe, Alba Cebrian Moreno, Eva Rivas, Manuel Lopez-Baamonde, Hamed Elgendy, Mohamed Sayedalahl, Abdul Razak SIibai, Aysen Yavru, Nukhet Sivrikoz, Meltem Karadeniz, Pelin Corman Dincer, Hilmi Omer Ayanoglu, Gulbin Tore Altun, Ayse Duygu Kavas, Bora Dinc, Bahar Kuvaki, Sule Ozbilgin, Dilek Erdogan, Ceren Koksal, Suheyla Abitagaglu, Caterina Aurilio, Pasquale Sansone, Caterina Maria Pace, Valerio Donatiello, Silvana Mattera, Palange Nazareno, Salvatore Di Colandrea, Savino Spadaro, Carlo Alberto Volta, Riccardo Ragazzi, Stefano Ciardo, Luca Gobbi, Paolo Severgnini, Alessandro Bacuzzi, Elisa Brugnoni, Angelo Gratarola, Camilla Micalizzi, Francesca Simonassi, Patrizia Malerbi, Adrea Carboni, Marc-Joseph Licker, Alexander Dullenkopf, Nicolai Goettel, Visnja Nesek Adam, Maja Karaman Ilić, Vlasta Klaric, Bibiana Vitkovic, Morena Milic, Miro Zupcic, Luc De Baerdemaeker, Stefan De Hert, Bjorn Heyse, Jurgen Van Limmen, Yves Van Nieuwenhove, Els Mertens, Arne Neyrinck, Jan Mulier, David Kahn, Daniela Godoroja, Martin Martin-Loeches, Sergiy Vorotyntsev, Valentyna Fronchko, Idit Matot, Or Goren, Lilach Zac, Thomasz Gaszynski, Jon Laffey, Gary Mills, Pramod Nalwaya, Mark Mac Gregor, Jonathan Paddle, Packianathaswamy Balaji, Francesca Rubulotta, Afeez Adebesin, Mike Margarson, Simon Davies, Desikan Rangarajan, Christopher Newell, Mirjana Shosholcheva, Fotios Papaspyros, Vasiliki Skandalou, Paula Dzurňáková

Open Access Research

Comparative costs and activity from a sample of UK clinical trials units

Daniel Hind, Barnaby C. Reeves, Sarah Bathers, Christopher Bray, Andrea Corkhill, Christopher Hayward, Lynda Harper, Vicky Napp, John Norrie, Chris Speed, Liz Tremain, Nicola Keat, Mike Bradburn

Open Access Research

Subversion of allocation concealment in a randomised controlled trial: a historical case study

Andrew D. M. Kennedy, David J. Torgerson, Marion K. Campbell, Adrian M. Grant

Open Access Research

Assessing the quality of reports about randomized controlled trials of scalp acupuncture treatment for vascular dementia

Young-Nim You, Myung-Rae Cho, Ju-Hyung Park, Gwang-Cheon Park, Min-Yeong Song, Jin-Bong Choi, Chang-Su Na, Jae-Young Han, Jeong-cheol Shin, Jae-Hong Kim

Open Access Study protocol

The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial

Kate Sitnikova, Stephanie S. Leone, Lyonne N. L. Zonneveld, Harm W. J. van Marwijk, Judith E. Bosmans, Johannes C. van der Wouden, Henriëtte E. van der Horst

Open Access Methodology

Sequence balance minimisation: minimising with unequal treatment allocations

Vichithranie W. Madurasinghe

Open Access Study protocol

Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial

Michele Brignole, Marco Tomaino, Arnaud Aerts, Fabrizio Ammirati, Félix Alejandro Ayala-Paredes, Jean-Claude Deharo, Attilio Del Rosso, Mohamed H. Hamdan, Maurizio Lunati, Angel Moya, Alessio Gargaro

Open Access Study protocol

Effect of supervised exercise in groups on psychological well-being among pregnant women at risk of depression (the EWE Study): study protocol for a randomized controlled trial

Lotte Broberg, Mette Backhausen, Peter Damm, Per Bech, Ann Tabor, Hanne Kristine Hegaard

Open Access Study protocol

Improving practice guidelines for the treatment of denture-related erythematous stomatitis: a study protocol for a randomized controlled trial

Raphael F. de Souza, Muhammad Faheem Khiyani, Carolina A. L. Chaves, Jocelyne Feine, Jean Barbeau, Ramón Fuentes, Eduardo Borie, Luciana C. Crizostomo, Claudia H. Silva-Lovato, Pierre Rompre, Elham Emami

Open Access Study protocol

The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial

Aron Onerup, Eva Angenete, David Bock, Mats Börjesson, Monika Fagevik Olsén, Elin Grybäck Gillheimer, Stefan Skullman, Sven-Egron Thörn, Eva Haglind, Hanna Nilsson

Open Access Erratum

Erratum to: Keratinocyte growth factor in acute lung injury to reduce pulmonary dysfunction – a randomised placebo-controlled trial (KARE): study protocol

Laurence J. M. Cross, Cecilia M. O’Kane, Cliona McDowell, Jospeh J. Elborn, Michael A. Matthay, Daniel F. McAuley

Open Access Study protocol

Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial

Cezar Giosan, Oana Cobeanu, Cristina Mogoaşe, Aurora Szentagotai, Vlad Mureşan, Rareș Boian

Open Access Research

A feasibility randomised controlled trial of extended brief intervention for alcohol misuse in adults with mild to moderate intellectual disabilities living in the community; The EBI-LD study

Christos Kouimtsidis, Alessandro Bosco, Katrina Scior, Gianluca Baio, Rachael Hunter, Vittoria Pezzoni, Eileen Mcnamara, Angela Hassiotis

Open Access Study protocol

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial

Hants Williams, Susan Silva, Leigh Ann Simmons, Paula Tanabe

Open Access Research

The INVEST project: investigating the use of evidence synthesis in the design and analysis of clinical trials

Gemma L. Clayton, Isabelle L. Smith, Julian P. T. Higgins, Borislava Mihaylova, Benjamin Thorpe, Robert Cicero, Kusal Lokuge, Julia R. Forman, Jayne F. Tierney, Ian R. White, Linda D. Sharples, Hayley E. Jones

Open Access Research

HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients

Noor Heim, Henk F. van Stel, Roelof G. Ettema, Roos C. van der Mast, Sharon K. Inouye, Marieke J. Schuurmans

Open Access Study protocol

The SITLESS project: exercise referral schemes enhanced by self-management strategies to battle sedentary behaviour in older adults: study protocol for a randomised controlled trial

Maria Giné-Garriga, Laura Coll-Planas, Míriam Guerra, Àlex Domingo, Marta Roqué, Paolo Caserotti, Michael Denkinger, Dietrich Rothenbacher, Mark A. Tully, Frank Kee, Emma McIntosh, Carme Martín-Borràs, Guillermo R. Oviedo, Javier Jerez-Roig, Marta Santiago, Oriol Sansano, Guillermo Varela, Mathias Skjødt, Katharina Wirth, Dhayana Dallmeier, Jochen Klenk, Jason J. Wilson, Nicole E. Blackburn, Manuela Deidda, Guillaume Lefebvre, Denise González, Antoni Salvà

Open Access Study protocol

Effects of nurse telesupport on transition between specialized and primary care in diabetic patients: study protocol for a randomized controlled trial

Ana Marina Moreira, Roberta Marobin, Dimitris Varvaki Rados, Camila Bergonsi de Farias, Sabrina Coelli, Bárbara Luiza Bernardi, Lívia de Almeida Faller, Laura Ferraz dos Santos, Ana Maria Matzenbacher, Natan Katz, Erno Harzheim, Sandra Pinho Silveiro

Open Access Study protocol

Does the use of the Informed Healthcare Choices (IHC) primary school resources improve the ability of grade-5 children in Uganda to assess the trustworthiness of claims about the effects of treatments: protocol for a cluster-randomised trial

Allen Nsangi, Daniel Semakula, Andrew D. Oxman, Matthew Oxman, Sarah Rosenbaum, Astrid Austvoll-Dahlgren, Laetitia Nyirazinyoye, Margaret Kaseje, Iain Chalmers, Atle Fretheim, Nelson K. Sewankambo

Open Access Study protocol

BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial

Benjamin D. Hunt, Matthew A. Popplewell, Huw Davies, Lewis Meecham, Hugh Jarrett, Gareth Bate, Margaret Grant, Smitaa Patel, Catherine Hewitt, Lazaros Andronis, Jonathan J. Deeks, Andrew Bradbury

Open Access Study protocol

A multimodal day treatment program for multi-problem young adults: study protocol for a randomized controlled trial

Marie-Jolette A. Luijks, Floor Bevaart, Josjan Zijlmans, Laura van Duin, Reshmi Marhe, Theo A. H. Doreleijers, Henning Tiemeier, Jessica J. Asscher, Arne Popma

Open Access Study protocol

Laparoscopic Roux-en-Y gastric bypass versus laparoscopic mini gastric bypass in the treatment of obesity: study protocol for a randomized controlled trial

Marko Kraljević, Tarik Delko, Thomas Köstler, Elena Osto, Thomas Lutz, Sarah Thommen, Raoul A. Droeser, Lincoln Rothwell, Daniel Oertli, Urs Zingg

Open Access Research

Barriers and facilitators to healthcare professional behaviour change in clinical trials using the Theoretical Domains Framework: a case study of a trial of individualized temperature-reduced haemodialysis

Justin Presseau, Brittany Mutsaers, Ahmed A. Al-Jaishi, Janet Squires, Christopher W. McIntyre, Amit X. Garg, Manish M. Sood, Jeremy M. Grimshaw, Amit Bagga, Andre Charest, Andrew Steele, Arsh Jain, Charmaine Lok, David Berry, David Perkins, Rebecca Harvey, Davinder Wadehra, Derek Benjamin, Eduard Iliescu, Eli Rabin, Garth Hanson, Gihad Nesrallah, Joanna Sasal, Jessica M. Sontrop, Laura Gregor, Leo Lam, Malvinder Parmar, Matthew Oliver, Michael Walsh, Nicole Delbrouck, Patricia Chan, Paul Tam, Paul Watson, Peter Blake, Phillip Zager, PJ Devereaux, Reem Mustafa, Rey Acedillo, Richard Goluch, Ron Wald, Sanjay Pandeya, Stephanie Dixon, Tanya Schulman, Walter Wodchis

Open Access Study protocol

Efficacy, cost-utility and reach of an eHealth self-management application 'Oncokompas' that helps cancer survivors to obtain optimal supportive care: study protocol for a randomised controlled trial

Anja van der Hout, Cornelia F. van Uden-Kraan, Birgit I. Witte, Veerle M. H. Coupé, Femke Jansen, C. René Leemans, Pim Cuijpers, Lonneke V. van de Poll-Franse, Irma M. Verdonck-de Leeuw

Open Access Study protocol

Perfusion by Arterial Spin labelling following Single dose Tadalafil In Small vessel disease (PASTIS): study protocol for a randomised controlled trial

Mathilde M. H. Pauls, Natasha Clarke, Sarah Trippier, Shai Betteridge, Franklyn A. Howe, Usman Khan, Christina Kruuse, Jeremy B. Madigan, Barry Moynihan, Anthony C. Pereira, Debbie Rolfe, Egill Rostrup, Caroline E. Haig, Thomas R. Barrick, Jeremy D. Isaacs, Atticus H. Hainsworth

Open Access Study protocol

Fibrates for the treatment of cholestatic itch (FITCH): study protocol for a randomized controlled trial

Ruth Bolier, Elsemieke S. de Vries, Albert Parés, Jeltje Helder, E. Marleen Kemper, Koos Zwinderman, Ronald P. Oude Elferink, Ulrich Beuers, Henk R. van Buuren, Joost P. Drenth, Karel J. van Erpecum, Bart van Hoek, Peter L. M. Jansen, Karin M. van Nieuwkerk, J. Marleen de Vree

Open Access Erratum

Erratum to: Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial

Sang-Don Park, Chang-Hwan Yoon, Il-Young Oh, Jung-Won Suh, Young-Suk Cho, Tae-Jin Youn, Dong-Ju Choi, In-Ho Chae

Open Access Study protocol

The effect of a mindfulness-based intervention in cognitive functions and psychological well-being applied as an early intervention in schizophrenia and high-risk mental state in a Chilean sample: study protocol for a randomized controlled trial

Álvaro I. Langer, Carlos Schmidt, Rocío Mayol, Marcela Díaz, Javiera Lecaros, Edwin Krogh, Aída Pardow, Carolina Vergara, Guillermo Vergara, Bernardita Pérez-Herrera, María José Villar, Alejandro Maturana, Pablo A. Gaspar

Open Access Study protocol

Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial

Sarah Ballou, Ted J. Kaptchuk, William Hirsch, Judy Nee, Johanna Iturrino, Kathryn T. Hall, John M. Kelley, Vivian Cheng, Irving Kirsch, Eric Jacobson, Lisa Conboy, Anthony Lembo, Roger B. Davis

Open Access Study protocol

Feasibility of a Systematic, Comprehensive, One-to-One Training (SCOOT) program for new scooter users: study protocol for a randomized control trial

W. Ben Mortenson, Sharon Jang, Charlie H. Goldsmith, Laura Hurd Clarke, Sandra Hobson, Richelle Emery

Open Access Research

A focused ethnography of a Child and Adolescent Mental Health Service: factors relevant to the implementation of a depression trial

C. E. W. Kitchen, S. Lewis, P. A. Tiffin, P. R. Welsh, L. Howey, D. Ekers

Open Access Update

Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol

Chris Bonell, Anne Mathiot, Elizabeth Allen, Leonardo Bevilacqua, Deborah Christie, Diana Elbourne, Adam Fletcher, Richard Grieve, Rosa Legood, Stephen Scott, Emily Warren, Meg Wiggins, Russell M. Viner

Open Access Study protocol

The Shared Health Appointments and Reciprocal Enhanced Support (SHARES) study: study protocol for a randomized trial

Michele Heisler, Jennifer Burgess, Jeffrey Cass, John F. Chardos, Alexander B. Guirguis, Sean M. Jeffery, Lorrie A. Strohecker, Adam S. Tremblay, Wen-Chih Wu, Donna M. Zulman

Open Access Study protocol

Anesthetic management of cesarean section in cases of placenta accreta, with versus without abdominal aortic balloon occlusion: study protocol for a randomized controlled trial

Qinjun Chu, Dan Shen, Long He, Hongwei Wang, Xianlan Zhao, Zhimin Chen, Yanli Wang, Wei Zhang

Open Access Study protocol

Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial

James Winearls, Martin Wullschleger, Elizabeth Wake, Catherine Hurn, Jeremy Furyk, Glenn Ryan, Melita Trout, James Walsham, Anthony Holley, Jeremy Cohen, Megan Shuttleworth, Wayne Dyer, Gerben Keijzers, John F Fraser, Jeffrey Presneill, Don Campbell

Open Access Letter

Response to letter to editor: ‘Comment on Arch et al., Trials. 2016;17:517’

B. N. Arch, J. Blair, A. McKay, J. W. Gregory, P. Newland, C. Gamble

Open Access Study protocol

The effects of a psychological intervention directed at optimizing immune function: study protocol for a randomized controlled trial

Lemmy Schakel, Dieuwke S. Veldhuijzen, Henriët van Middendorp, Corine Prins, Simone A. Joosten, Tom H. M. Ottenhoff, Leo G. Visser, Andrea W. M. Evers

Open Access Erratum

Erratum to Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial

T. Bluth, R. Teichmann, T. Kiss, I. Bobek, J. Canet, G. Cinnella, L. De Baerdemaeker, C. Gregoretti, G. Hedenstierna, S. N. Hemmes, M. Hiesmayr, M. W. Hollmann, S. Jaber, J. G. Laffey, M. J. Licker, K. Markstaller, I. Matot, G. Müller, G. H. Mills, J. P. Mulier, C. Putensen, R. Rossaint, J. Schmitt, M. Senturk, A. Serpa Neto, P. Severgnini, J. Sprung, M. F. Vidal Melo, H. Wrigge, M. J. Schultz, P. Pelosi, Marcelo Gama de Abreu

Open Access Erratum

Erratum to Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial

Caroline A. Smith, Sheryl de Lacey, Michael Chapman, Julie Ratcliffe, Robert J. Norman, Neil Johnson, Gavin Sacks, Jane Lyttleton, Clare Boothroyd

Open Access Study protocol

Effectiveness of additional trunk exercises on gait performance: study protocol for a randomized controlled trial

Tamaya Van Criekinge, Wim Saeys, Ann Hallemans, Luc Vereeck, Willem De Hertogh, Patricia Van de Walle, Nathalie Vaes, Christophe Lafosse, Steven Truijen

Open Access Study protocol

Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial

LS Nascimento, AC Santos, JMS Lucena, LGO Silva, AEM Almeida, MS Brasileiro-Santos

Open Access Study protocol

Influences of De Qi induced by acupuncture on immediate and accumulated analgesic effects in patients with knee osteoarthritis: study protocol for a randomized controlled trial

Min Li, Hongwen Yuan, Pei Wang, Siyuan Xin, Jie Hao, Miaomiao Liu, Jinfeng Li, Man Yu, Xinrui Zhang

Open Access Study protocol

Steroids in chronic subdural hematomas (SUCRE trial): study protocol for a randomized controlled trial

Pierre-Louis Henaux, Pierre-Jean Le Reste, Bruno Laviolle, Xavier Morandi

Open Access Study protocol

Live birth after fresh versus frozen single blastocyst transfer (Frefro-blastocyst): study protocol for a randomized controlled trial

Daimin Wei, Yun Sun, Jiayin Liu, Xiaoyan Liang, Yimin Zhu, Yuhua Shi, Zi-Jiang Chen

Open Access Study protocol

Fatigue mitigation with SleepTrackTXT2 in air medical emergency care systems: study protocol for a randomized controlled trial

P. Daniel Patterson, Charity G. Moore, Frank X. Guyette, Jack M. Doman, Denisse Sequeira, Howard A. Werman, Doug Swanson, David Hostler, Joshua Lynch, Lindsey Russo, Linda Hines, Karen Swecker, Michael S. Runyon, Daniel J. Buysse

Open Access Study protocol

A double-blind randomised controlled investigation into the efficacy of Mirococept (APT070) for preventing ischaemia reperfusion injury in the kidney allograft (EMPIRIKAL): study protocol for a randomised controlled trial

Theodoros Kassimatis, Anass Qasem, Abdel Douiri, Elizabeth G. Ryan, Irene Rebollo-Mesa, Laura L. Nichols, Roseanna Greenlaw, Jonathon Olsburgh, Richard A. Smith, Steven H. Sacks, Martin Drage

Open Access Study protocol

Hypertension with unsatisfactory sleep health (HUSH): study protocol for a randomized controlled trial

Jessica C. Levenson, Bruce L. Rollman, Lee M. Ritterband, Patrick J. Strollo, Kenneth J. Smith, Jonathan G. Yabes, Charity G. Moore, Allison G. Harvey, Daniel J. Buysse

Open Access Update

COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial

Emily J. Robinson, Laura H. Goldstein, Paul McCrone, Iain Perdue, Trudie Chalder, John D. C. Mellers, Mark P. Richardson, Joanna Murray, Markus Reuber, Nick Medford, Jon Stone, Alan Carson, Sabine Landau

Open Access Study protocol

The effects of green cardamom on blood glucose indices, lipids, inflammatory factors, paraxonase-1, sirtuin-1, and irisin in patients with nonalcoholic fatty liver disease and obesity: study protocol for a randomized controlled trial

Milad Daneshi-Maskooni, Seyed Ali Keshavarz, Siavash Mansouri, Mostafa Qorbani, Seyed Moayed Alavian, Mahtab Badri-Fariman, Seyed Ali Jazayeri-Tehrani, Gity Sotoudeh

Open Access Study protocol

Impact of community-initiated Kangaroo Mother Care on survival of low birth weight infants: study protocol for a randomized controlled trial

Sarmila Mazumder, Sunita Taneja, Suresh Kumar Dalpath, Rakesh Gupta, Brinda Dube, Bireshwar Sinha, Kiran Bhatia, Sachiyo Yoshida, Ole Frithjof Norheim, Rajiv Bahl, Halvor Sommerfelt, Nita Bhandari, Jose Martines

Open Access Study protocol

Real versus sham proximal biofield therapy in the treatment of warts of the hands and feet in adults: study protocol for a randomized controlled trial (MAGNETIK study)

Cathy Gaillard, Laure Allain, Hélène Legros, Sylvie Brucato, Yohann Desgue, Christophe Rouillon, Laure Peyro-Saint-Paul, Anne Dompmartin

Open Access Study protocol

Different strategies for mechanical VENTilation during CardioPulmonary Bypass (CPBVENT 2014): study protocol for a randomized controlled trial

Elena Bignami, Marcello Guarnieri, Francesco Saglietti, Enivarco Massimo Maglioni, Sabino Scolletta, Stefano Romagnoli, Stefano De Paulis, Gianluca Paternoster, Cinzia Trumello, Roberta Meroni, Antonio Scognamiglio, Alessandro Maria Budillon, Vincenzo Pota, Alberto Zangrillo, Ottavio Alfieri

Open Access Study protocol

Developing and evaluating multimedia information resources to improve engagement of children, adolescents, and their parents with trials (TRECA study): Study protocol for a series of linked randomised controlled trials

Jacqueline Martin-Kerry, Peter Bower, Bridget Young, Jonathan Graffy, Rebecca Sheridan, Ian Watt, Paul Baines, Catherine Stones, Jennifer Preston, Steven Higgins, Carrol Gamble, Peter Knapp

Open Access Methodology

A comparison of approaches for adjudicating outcomes in clinical trials

Brennan C. Kahan, Brian Feagan, Vipul Jairath

Open Access Study protocol

A multicentre, randomised intervention study of the Paediatric Early Warning Score: study protocol for a randomised controlled trial

Claus Sixtus Jensen, Hanne Aagaard, Hanne Vebert Olesen, Hans Kirkegaard

Open Access Study protocol

The efficacy and safety of Danggui-Sayuk-Ga-Osuyu-Saenggang-tang on Korean patients with cold hypersensitivity in the hands: study protocol for a pilot, double-blind, randomized, placebo-controlled, parallel-group clinical trial

Youme Ko, Ho-Yeon Go, Yoon-Young Cho, Ji-Hye Shin, Tae-Hoon Kim, Dong-Jun Choi, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seong-Gyu Ko, Seung-Ho Sun, Chan-Yong Jeon

Open Access Erratum

Erratum to Benefit of dual-chamber pacing with Closed Loop Stimulation in tilt-induced cardio-inhibitory reflex syncope (BIOSync trial): study protocol for a randomized controlled trial

Michele Brignole, Marco Tomaino, Arnaud Aerts, Fabrizio Ammirati, Félix Alejandro Ayala-Paredes, Jean-Claude Deharo, Attilio Del Rosso, Mohamed H. Hamdan, Maurizio Lunati, Angel Moya, Alessio Gargaro

Open Access Study protocol

Choosing the target difference (‘effect size’) for a randomised controlled trial - DELTA2 guidance protocol

Jonathan A. Cook, Steven A. Julious, William Sones, Joanne C. Rothwell, Craig R. Ramsay, Lisa V. Hampson, Richard Emsley, Stephen J. Walters, Catherine Hewitt, Martin Bland, Dean A. Fergusson, Jesse A. Berlin, Doug Altman, Luke D. Vale

Open Access Study protocol

Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial

Tazeen H. Jafar, Imtiaz Jehan, H. Asita de Silva, Aliya Naheed, Mihir Gandhi, Pryseley Assam, Eric A. Finkelstein, Helena Legido Quigley, Marcel Bilger, Aamir Hameed Khan, John David Clemens, Shah Ebrahim, Elizabeth L. Turner, Anuradhani Kasturiratne

Open Access Research

BADERI: an online database to coordinate handsearching activities of controlled clinical trials for their potential inclusion in systematic reviews

Hector Pardo-Hernandez, Gerard Urrútia, Leticia A. Barajas-Nava, Diana Buitrago-Garcia, Julieth Vanessa Garzón, María José Martínez-Zapata, Xavier Bonfill

Open Access Update

Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial

Lauren Bell, Richard Hooper, Catey Bunce, Saruban Pasu, James Bainbridge

Open Access Study protocol

Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL): study protocol for a randomised controlled trial

Peter Saunders, Vicky Tsipouri, Gregory J. Keir, Deborah Ashby, Marcus D. Flather, Helen Parfrey, Daphne Babalis, Elisabetta A. Renzoni, Christopher P. Denton, Athol U. Wells, Toby M. Maher

Open Access Study protocol

Evaluating the effectiveness of a healthy lifestyle clinician in addressing the chronic disease risk behaviours of community mental health clients: study protocol for a randomised controlled trial

Caitlin Fehily, Kate Bartlem, John Wiggers, Paula Wye, Richard Clancy, David Castle, Sonia Wutzke, Chris Rissel, Andrew Wilson, Paul McCombie, Fionna Murphy, Jenny Bowman

Open Access Study protocol

Reducing the rate and duration of Re-ADMISsions among patients with unipolar disorder and bipolar disorder using smartphone-based monitoring and treatment – the RADMIS trials: study protocol for two randomized controlled trials

Maria Faurholt-Jepsen, Mads Frost, Klaus Martiny, Nanna Tuxen, Nicole Rosenberg, Jonas Busk, Ole Winther, Jakob Eyvind Bardram, Lars Vedel Kessing

Open Access Study protocol

Effects of digital Cognitive Behavioural Therapy for Insomnia on cognitive function: study protocol for a randomised controlled trial

Simon D. Kyle, Madeleine E. D. Hurry, Richard Emsley, Annemarie I. Luik, Ximena Omlin, Kai Spiegelhalder, Colin A. Espie, Claire E. Sexton

Open Access Study protocol

Emergency treatment with levetiracetam or phenytoin in status epilepticus in children—the EcLiPSE study: study protocol for a randomised controlled trial

Mark D. Lyttle, Carrol Gamble, Shrouk Messahel, Helen Hickey, Anand Iyer, Kerry Woolfall, Amy Humphreys, Naomi E. A. Bacon, Louise Roper, Franz E. Babl, Stuart R. Dalziel, Mary Ryan, Richard E. Appleton

Open Access Study protocol

Improving child nutrition and development through community-based childcare centres in Malawi – The NEEP-IE study: study protocol for a randomised controlled trial

Aulo Gelli, Amy Margolies, Marco Santacroce, Katie Sproule, Sophie Theis, Natalie Roschnik, Aisha Twalibu, George Chidalengwa, Amrik Cooper, Tyler Moorhead, Melissa Gladstone, Patricia Kariger, Mangani Kutundu

Open Access Study protocol

Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial

Jun Wang, Jian Pei, Dhiaedin Khiati, Qinhui Fu, Xiao Cui, Yi Song, Minghang Yan, Lijun Shi, Yiwen Cai, Yuhong Ma

Open Access Research

Current globalization of drug interventional clinical trials: characteristics and associated factors, 2011–2013

Sohyun Jeong, Minji Sohn, Jae Hyun Kim, Minoh Ko, Hee-won Seo, Yun-Kyoung Song, Boyoon Choi, Nayoung Han, Han-Sung Na, Jong Gu Lee, In-Wha Kim, Jung Mi Oh, Euni Lee

Open Access Study protocol

Euiiyin-tang in the treatment of obesity: study protocol for a randomised controlled trial

Chunhoo Cheon, Soobin Jang, Jeong-Su Park, Youme Ko, Doh Sun Kim, Byung Hoon Lee, Hyun Jong Song, Yun-Kyung Song, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko

Open Access Study protocol

The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) – standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial

Md Ali Katijjahbe, Linda Denehy, Catherine L. Granger, Alistair Royse, Colin Royse, Rebecca Bates, Sarah Logie, Sandy Clarke, Doa El-Ansary

Open Access Study protocol

Effect of acupuncture on cerebrovascular reserve in patients with acute cerebral infarction: protocol for a randomized controlled pilot study

Shaosong Wang, Tingting Ma, Linpeng Wang, Lu Liu, Huilin Liu, Bin Li, Yuanbo Fu

Open Access Study protocol

Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial

Michael H. Livingston, Sanjay Mahant, Felix Ratjen, Bairbre L. Connolly, Kevin Thorpe, Muhammad Mamdani, Ian Maclusky, Sophie Laberge, Lucy Giglia, J. Mark Walton, Connie L. Yang, Ashley Roberts, Anna C. Shawyer, Mary Brindle, Simon J. Parsons, Cristina A. Stoian, Eyal Cohen

Open Access Study protocol

Ciprofloxacin for contacts of cases of meningococcal meningitis as an epidemic response: study protocol for a cluster-randomized trial

Matthew E. Coldiron, Gabriel Alcoba, Iza Ciglenecki, Matt Hitchings, Ali Djibo, Anne-Laure Page, Celine Langendorf, Rebecca F. Grais

Open Access Study protocol

The Risk of Oxygen during Cardiac Surgery (ROCS) trial: study protocol for a randomized clinical trial

Marcos G. Lopez, Mias Pretorius, Matthew S. Shotwell, Robert Deegan, Susan S. Eagle, Jeremy M. Bennett, Bantayehu Sileshi, Yafen Liang, Brian J. Gelfand, Adam J. Kingeter, Kara K. Siegrist, Frederick W. Lombard, Tiffany M. Richburg, Dane A. Fornero, Andrew D. Shaw, Antonio Hernandez, Frederic T. Billings IV

Open Access Study protocol

Acupuncture paired with herbal medicine for prediabetes: study protocol for a randomized controlled trial

Xinger Li, Haiyan Liu, Huiping Feng, Zhongren Xian, Yanhong Chen, Jianping Chen, Chunzhi Tang, Xinsheng Lai, Xiaoling Lan, Huanzhen Huang, Dongdong Yu

Open Access Study protocol

Cognitive Bias Modification for paranoia (CBM-pa): study protocol for a randomised controlled trial

Jenny Yiend, Antonella Trotta, Christopher Meek, Ilvana Dzafic, Nora Baldus, Bryony Crane, Thomas Kabir, Daniel Stahl, Margaret Heslin, Sukhwinder Shergill, Philip McGuire, Emmanuelle Peters

Open Access Study protocol

Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Nicolle M. Krebs, Sophia I. Allen, Susan Veldheer, Diane J. Martinez, Kimberly Horn, Craig Livelsberger, Jennifer Modesto, Robin Kuprewicz, Ashley Wilhelm, Shari Hrabovsky, Abid Kazi, Alyse Fazzi, Jason Liao, Junjia Zhu, Emily Wasserman, Samantha M. Reilly, Lisa Reinhart, Neil Trushin, Robinn E. Moyer, Rebecca Bascom, Jonathan Foulds, John P. Richie Jr., Joshua E. Muscat

Open Access Research

A red yeast rice-olive extract supplement reduces biomarkers of oxidative stress, OxLDL and Lp-PLA2, in subjects with metabolic syndrome: a randomised, double-blind, placebo-controlled trial

Nina Hermans, Anastasia Van der Auwera, Annelies Breynaert, Annelies Verlaet, Tess De Bruyne, Luc Van Gaal, Luc Pieters, Veronique Verhoeven

Open Access Study protocol

Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial

Florence Leclercq, Pierre Robert, Jessica Labour, Benoit Lattuca, Mariama Akodad, Jean-Christophe Macia, Richard Gervasoni, Francois Roubille, Thomas Gandet, Laurent Schmutz, Erika Nogue, Nicolas Nagot, Bernard Albat, Guillaume Cayla

Open Access Study protocol

Effectiveness of an intervention to improve supportive care for family caregivers of patients with lung cancer: study protocol for a randomized controlled trial

Michèle Aubin, Lucie Vézina, René Verreault, Sébastien Simard, Jean-François Desbiens, Lise Tremblay, Serge Dumont, Lise Fillion, Maman Joyce Dogba, Pierre Gagnon

Open Access Methodology

Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned

Olamide Ojo-Fati, Anne M. Joseph, Jed Ig-Izevbekhai, Janet L. Thomas, Susan A. Everson-Rose, Rebekah Pratt, Nancy Raymond, Ned L. Cooney, Xianghua Luo, Kolawole S. Okuyemi

Open Access Study protocol

Evaluation of the clinical benefit of an electromagnetic navigation system for CT-guided interventional radiology procedures in the thoraco-abdominal region compared with conventional CT guidance (CTNAV II): study protocol for a randomised controlled trial

RC. Rouchy, A. Moreau-Gaudry, E. Chipon, S. Aubry, L. Pazart, B. Lapuyade, M. Durand, M. Hajjam, S. Pottier, B. Renard, R. Logier, X. Orry, A. Cherifi, E. Quehen, G. Kervio, O. Favelle, F. Patat, E. De Kerviler, C. Hughes, M. Medici, J. Ghelfi, A. Mounier, I. Bricault

Open Access Study protocol

Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial

Claudia Hanson, Andrea B. Pembe, Fadhlun Alwy, Susan Atuhairwe, Sebalda Leshabari, Jessica Morris, Frank Kaharuza, Gaetano Marrone

Open Access Erratum

Erratum to: Effectiveness of a novel mobile health education intervention (Peek) on spectacle wear among children in India: study protocol for a randomized controlled trial

Priya Morjaria, Andrew Bastawrous, Gudlavalleti Venkata Satyanarayana Murthy, Jennifer Evans, Clare Gilbert

Open Access Study protocol

Warm-needling acupuncture and medicinal cake-separated moxibustion for hyperlipidemia: study protocol for a randomized controlled trial

Mailan Liu, Qian Zhang, Shan Jiang, Mi Liu, Guoshan Zhang, Zenghui Yue, Qin Chen, Jie Zhou, Yifan Zou, Dan Li, Mingzhu Ma, Guobin Dai, Huan Zhong, Zhihong Wang, Xiaorong Chang

Open Access Study protocol

The efficacy of traditional acupuncture on patients with chronic neck pain: study protocol of a randomized controlled trial

Yiling Yang, Xiaoxia Yan, Hongmei Deng, Dian Zeng, Jianpeng Huang, Wenbin Fu, Nenggui Xu, Jianhua Liu

Open Access Study protocol

The impact of phosphate-balanced crystalloid infusion on acid-base homeostasis (PALANCE study): study protocol for a randomized controlled trial

Judith-Irina Pagel, Nikolai Hulde, Tobias Kammerer, Michaela Schwarz, Daniel Chappell, Alexander Burges, Klaus Hofmann-Kiefer, Markus Rehm

Open Access Study protocol

Prevention and treatment of long-term social disability amongst young people with emerging severe mental illness with social recovery therapy (The PRODIGY Trial): study protocol for a randomised controlled trial

David Fowler, Paul French, Robin Banerjee, Garry Barton, Clio Berry, Rory Byrne, Timothy Clarke, Rick Fraser, Brioney Gee, Kathryn Greenwood, Caitlin Notley, Sophie Parker, Lee Shepstone, Jon Wilson, Alison R. Yung, Joanne Hodgekins

Open Access Study protocol

The impact of the time of drug administration on the effectiveness of combined treatment of hypercholesterolemia with Rosuvastatin and Ezetimibe (RosEze): study protocol for a randomized controlled trial

Karolina Obońska, Michał Kasprzak, Joanna Sikora, Ewa Obońska, Krzysztof Racki, Natalia Goździkiewicz, Magdalena Krintus, Jacek Kubica

Open Access Study protocol

Effect of aquatic physical therapy on pain perception, functional capacity and quality of life in older people with knee osteoarthritis: study protocol for a randomized controlled trial

Guilherme Eleutério Alcalde, Ana Carolina Fonseca, Thais Fernanda Bôscoa, Mirella Regina Gonçalves, Gabriele Candido Bernardo, Bruna Pianna, Bianca Ferdin Carnavale, Camila Gimenes, Silvia Regina Barrile, Eduardo Aguilar Arca

Open Access Research

Resource implications of preparing individual participant data from a clinical trial to share with external researchers

Catrin Tudur Smith, Sarah Nevitt, Duncan Appelbe, Richard Appleton, Pete Dixon, Janet Harrison, Anthony Marson, Paula Williamson, Elizabeth Tremain

Open Access Study protocol

Development of a core outcome set for clinical trials in squamous cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Daniel I. Schlessinger, Sanjana Iyengar, Arianna F. Yanes, Sarah G. Chiren, Victoria Godinez-Puig, Brian R. Chen, Anastasia O. Kurta, Jochen Schmitt, Stefanie Deckert, Karina C. Furlan, Emily Poon, Todd V. Cartee, Ian A. Maher, Murad Alam, Joseph F. Sobanko

Open Access Study protocol

Efficacy of umbilical cord cleansing with a single application of 4% chlorhexidine for the prevention of newborn infections in Uganda: study protocol for a randomized controlled trial

Victoria Nankabirwa, Thorkild Tylleskär, Josephine Tumuhamye, James K. Tumwine, Grace Ndeezi, José C. Martines, Halvor Sommerfelt

Open Access Update

A meta-analysis of temporal changes of response in the placebo arm of surgical randomized controlled trials: an update

Karolina A. Wartolowska, Stephen Gerry, Benjamin G. Feakins, Gary S. Collins, Jonathan Cook, Andrew Judge, Andrew J. Carr

Open Access Study protocol

Art therapy and music reminiscence activity in the prevention of cognitive decline: study protocol for a randomized controlled trial

Rathi Mahendran, Iris Rawtaer, Johnson Fam, Jonathan Wong, Alan Prem Kumar, Mihir Gandhi, Kenny Xu Jing, Lei Feng, Ee Heok Kua

Open Access Study protocol

Twin–Twin Transfusion Syndrome: study protocol for developing, disseminating, and implementing a core outcome set

Asma Khalil, Helen Perry, James Duffy, Keith Reed, Ahmet Baschat, Jan Deprest, Kurt Hecher, Liesbeth Lewi, Enrico Lopriore, Dick Oepkes

Open Access Study protocol

The effects of Cognitive Bias Modification training and oxytocin administration on trust in maternal support: study protocol for a randomized controlled trial

Martine W. F. T. Verhees, Eva Ceulemans, Marian J. Bakermans-Kranenburg, Marinus H. van IJzendoorn, Simon de Winter, Guy Bosmans

Open Access Research

Informed consent in randomised controlled trials: development and preliminary evaluation of a measure of Participatory and Informed Consent (PIC)

Julia Wade, Daisy Elliott, Kerry N. L. Avery, Daisy Gaunt, Grace J. Young, Rebecca Barnes, Sangeetha Paramasivan, W Bruce Campbell, Jane M. Blazeby, Alison J Birtle, Rob C. Stein, David J Beard, Alison W Halliday, Jenny L. Donovan

Open Access Study protocol

RETRACTED ARTICLE: Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial

Christoph Schnelle, Steffen Messerschmidt, Eunice J. Minford, Kate Greenaway-Twist, Maxine Szramka, Marianna Masiorski, Michelle Sheldrake, Mark Jones

Open Access Letter

Short-term impact of celebrating the international clinical trial day: experience from Ethiopia

Abebaw Fekadu, Asrat Hailu, Eyasu Makonnen, Anteneh Belete, Getnet Yimer

Open Access Review

Association of the FDA Amendment Act with trial registration, publication, and outcome reporting

Adam T. Phillips, Nihar R. Desai, Harlan M. Krumholz, Constance X. Zou, Jennifer E. Miller, Joseph S. Ross

Open Access Commentary

Blockchain technology for improving clinical research quality

Mehdi Benchoufi, Philippe Ravaud

Open Access Study protocol

Creation of a core outcome set for clinical trials of people with shoulder pain: a study protocol

Joel J. Gagnier, Matthew J. Page, Hsiaomin Huang, Arianne P. Verhagen, Rachelle Buchbinder

Open Access Study protocol

Effect of insulin therapy and dietary adjustments on safety and performance during simulated soccer tests in people with type 1 diabetes: study protocol for a randomized controlled trial

Javier Calvo-Marín, Gabriel Torrealba-Acosta, Matthew Campbell, Jesse Gaboury, Ajmol Ali, Chih Hao Chen-Ku

Open Access Study protocol

Patient-oriented education and medication management intervention for people with decompensated cirrhosis: study protocol for a randomized controlled trial

Kelly L. Hayward, Jennifer H. Martin, W. Neil Cottrell, Antara Karmakar, Leigh U. Horsfall, Preya J. Patel, David D. Smith, Katharine M. Irvine, Elizabeth E. Powell, Patricia C. Valery

Open Access Study protocol

Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial

Helen Rodgers, Lisa Shaw, Helen Bosomworth, Lydia Aird, Natasha Alvarado, Sreeman Andole, David L. Cohen, Jesse Dawson, Janet Eyre, Tracy Finch, Gary A. Ford, Jennifer Hislop, Steven Hogg, Denise Howel, Niall Hughes, Hermano Igo Krebs, Christopher Price, Lynn Rochester, Elaine Stamp, Laura Ternent, Duncan Turner, Luke Vale, Elizabeth Warburton, Frederike van Wijck, Scott Wilkes

Open Access Study protocol

Target-D: a stratified individually randomized controlled trial of the diamond clinical prediction tool to triage and target treatment for depressive symptoms in general practice: study protocol for a randomized controlled trial

Jane Gunn, Caroline Wachtler, Susan Fletcher, Sandra Davidson, Cathrine Mihalopoulos, Victoria Palmer, Kelsey Hegarty, Amy Coe, Elizabeth Murray, Christopher Dowrick, Gavin Andrews, Patty Chondros

Open Access Study protocol

Effectiveness and cost-effectiveness of daily all-over-body application of emollient during the first year of life for preventing atopic eczema in high-risk children (The BEEP trial): protocol for a randomised controlled trial

Joanne R. Chalmers, Rachel H. Haines, Eleanor J. Mitchell, Kim S. Thomas, Sara J. Brown, Matthew Ridd, Sandra Lawton, Eric L. Simpson, Michael J. Cork, Tracey H. Sach, Lucy E. Bradshaw, Alan A. Montgomery, Robert J. Boyle, Hywel C. Williams

Open Access Study protocol

Collaborative care for depression in general practice: study protocol for a randomised controlled trial

Ursula Ødum Brinck-Claussen, Nadja Kehler Curth, Annette Sofie Davidsen, John Hagel Mikkelsen, Marianne Engelbrecht Lau, Merete Lundsteen, Claudio Csillag, Kaj Sparle Christensen, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov

Open Access Study protocol

Effectiveness and cost-effectiveness of embedded simulation in occupational therapy clinical practice education: study protocol for a randomised controlled trial

Christine Imms, Eli Mang Yee Chu, Stephen Guinea, Loretta Sheppard, Elspeth Froude, Rob Carter, Susan Darzins, Samantha Ashby, Susan Gilbert-Hunt, Nigel Gribble, Kelli Nicola-Richmond, Merrolee Penman, Elena Gospodarevskaya, Erin Mathieu, Mark Symmons

Open Access Study protocol

Retroclavicular approach vs infraclavicular approach for plexic bloc anesthesia of the upper limb: study protocol randomized controlled trial

PL Langlois, AF Gil-Blanco, D Jessop, Y Sansoucy, F D’Aragon, N Albert, P Echave

Open Access Study protocol

The effectiveness of an educational intervention for sodium restriction in patients with hypertension: study protocol for a randomized controlled trial

Marcela Perdomo Rodrigues, Luciana Kaercher John dos Santos, Flavio Danni Fuchs, Sandra Costa Fuchs, Leila Beltrami Moreira

Open Access Study protocol

Investigating interventions to increase uptake of HIV testing and linkage into care or prevention for male partners of pregnant women in antenatal clinics in Blantyre, Malawi: study protocol for a cluster randomised trial

Augustine T. Choko, Katherine Fielding, Nigel Stallard, Hendramoorthy Maheswaran, Aurelia Lepine, Nicola Desmond, Moses K. Kumwenda, Elizabeth L. Corbett

Open Access Study protocol

Impact of improved recording of work-relatedness in primary care visits at occupational health services on sickness absences: study protocol for a randomised controlled trial

Salla Atkins, Ulla Ojajärvi, Nina Talola, Mervi Viljamaa, Jaakko Nevalainen, Jukka Uitti

Open Access Study protocol

GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) trial: study protocol for a phase II/III randomised controlled trial

Jamie B. Oughton, Laura Collett, Dena R. Howard, Anna Hockaday, Talha Munir, Kathryn McMahon, Lucy McParland, Claire Dimbleby, David Phillips, Andy C. Rawstron, Peter Hillmen

Open Access Study protocol

A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial

Xuyang Yang, Qingbin Wu, Chengwu Jin, Wanbin He, Meng Wang, Tinghan Yang, Mingtian Wei, Xiangbing Deng, Wenjian Meng, Ziqiang Wang

Open Access Study protocol

The intervention process in the European Fans in Training (EuroFIT) trial: a mixed method protocol for evaluation

I. van de Glind, C. Bunn, C. M. Gray, K. Hunt, E. Andersen, J. Jelsma, H. Morgan, H. Pereira, G. Roberts, J. Rooksby, Ø. Røynesdal, M. Silva, M. Sorensen, S. Treweek, T. van Achterberg, H. van der Ploeg, F. van Nassau, M. Nijhuis-van der Sanden, S. Wyke

Open Access Study protocol

Magnetic resonance Adenosine perfusion imaging as Gatekeeper of invasive coronary intervention (MAGnet): study protocol for a randomized controlled trial

Dominik Buckert, Simon Witzel, Maciej Cieslik, Raid Tibi, Wolfgang Rottbauer, Peter Bernhardt

Open Access Study protocol

Development of a core outcome set for clinical trials in facial aging: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Daniel I. Schlessinger, Sanjana Iyengar, Arianna F. Yanes, Jill K. Henley, Hovik J. Ashchyan, Anastasia O. Kurta, Payal M. Patel, Umar A. Sheikh, Matthew J. Franklin, Courtney C. Hanna, Brian R. Chen, Sarah G. Chiren, Jochen Schmitt, Stefanie Deckert, Karina C. Furlan, Emily Poon, Ian A. Maher, Todd V. Cartee, Joseph F. Sobanko, Murad Alam

Open Access Review

Barriers to the conduct of randomised clinical trials within all disease areas

Snezana Djurisic, Ana Rath, Sabrina Gaber, Silvio Garattini, Vittorio Bertele, Sandra-Nadia Ngwabyt, Virginie Hivert, Edmund A. M. Neugebauer, Martine Laville, Michael Hiesmayr, Jacques Demotes-Mainard, Christine Kubiak, Janus C. Jakobsen, Christian Gluud

Open Access Research

‘We knew it was a totally at random thing’: parents’ experiences of being part of a neonatal trial

Merryl Harvey, Phumza Nongena, David Edwards, Maggie Redshaw

Open Access Study protocol

Pulsed radiofrequency or anterior neurectomy for anterior cutaneous nerve entrapment syndrome (ACNES) (the PULSE trial): study protocol of a randomized controlled trial

Robbert C. Maatman, Monique A. H. Steegers, Oliver B. A. Boelens, Toine C. Lim, Hans J. van den Berg, Sandra A. S. van den Heuvel, Marc R. M. Scheltinga, Rudi M. H. Roumen

Open Access Study protocol

Jail-to-community treatment continuum for adults with co-occurring substance use and mental disorders: study protocol for a pilot randomized controlled trial

Richard A. Van Dorn, Sarah L. Desmarais, Candalyn B. Rade, Elizabeth N. Burris, Gary S. Cuddeback, Kiersten L. Johnson, Stephen J. Tueller, Megan L. Comfort, Kim T. Mueser

Open Access Study protocol

Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study

Aliki Tsichlaki, Kevin O’Brien, Ama Johal, Zoe Marshman, Philip Benson, Fiorella B. Colonio Salazar, Padhraig S. Fleming

Open Access Study protocol

Determining the efficacy of guppies and pyriproxyfen (Sumilarv® 2MR) combined with community engagement on dengue vectors in Cambodia: study protocol for a randomized controlled trial

John Hustedt, Dyna Doum, Vanney Keo, Sokha Ly, BunLeng Sam, Vibol Chan, Neal Alexander, John Bradley, Didot Budi Prasetyo, Agus Rachmat, Shafique Muhammad, Sergio Lopes, Rithea Leang, Jeffrey Hii

Open Access Study protocol

To evaluate if increased supervision and support of South African Government health workers’ home visits improves maternal and child outcomes: study protocol for a randomized control trial

Mary Jane Rotheram-Borus, Karl Le Roux, Ingrid M. Le Roux, Joan Christodoulou, Christina Laurenzi, Nokwanele Mbewu, Mark Tomlinson

Open Access Study protocol

Effectiveness of a low-fructose and/or low-sucrose diet in decreasing insulin resistance (DISFRUTE study): study protocol for a randomized controlled trial

Santiago Domínguez Coello, Lourdes Carrillo Fernández, Jesús Gobierno Hernández, Manuel Méndez Abad, Carlos Borges Álamo, José Antonio García Dopico, Armando Aguirre Jaime, Antonio Cabrera de León, Nieves Expósito Álvarez, Fátima Fúster Jorge, Juan Carlos Marquez García, Juliana Martín Conde, Laura Moreno Calvo, Juan José Pérez Valencia, Ana Plasencia Barrera, Rafael Valcárcel López, Jorge Conde Pérez, José A. Fernández Hernández, Raquel García Álvarez, Manuel Ramos Fuentes, Concepción Ramos Ramos, Alicia Rodríguez Díaz, Myriam Sánchez Pérez, María J. Brito Cabrera, Mercedes Dorta Espiñero, Oscar Ginovés Sierra, Ana González Licerán, Javier Lorenzo Toledo, Rosa A. Marrero Delgado, Eva M. Morales Medina, Nayra Negrín Torres, Eduardo Orihuela Cabrera, Betty Pérez González, Oscar Guillermo Pérez Martín, Andrés Ramos Hernández, Soraya Sotto Rodríguez, Gilberto Gorrín Vargas, Candelaria Correa Hernández, Maite Díez Martín, Beatriz García Sanchez-Real, Alicia A. López Díaz, Francisco Rodríguez López, María C. Rodríguez Santos, María Candelaria García Méndez, Daisy Herrera Hernández, José. R. Hernández Lorenzo, José Martín Hernández, Antonio M. Reyes Rodríguez, José M. Rodríguez Hage, Inmaculada Sanz Sánchez, Luisa María Fernández Palacio, Piedad González Torrado, Tomás Higueras Linares, Alberto Martel Martell, Marta Pérez Souto, Nélida Olivares Hernández, Teresa Valdés Bilbao, Olga T. Gómez López, Ubaldo González Rodríguez, Mariana Morales López, María Calviño Oliver, Sara Farrais Villalba, Ascención C. García Morín, María D. Marrero Díaz, José A. Milena Jiménez, María P. Morales García, María V. Muñoz Fernández, Dulce E. Carmona Piñero, María R. García Marrero, Genoveva Pérez Pérez, Eduardo Puerta del Castillo, Juan L. Delgado Estévez, María T. Diestre Ortín, Carlos J. Fernández Barreto, María J. Pérez Hernández, Carmen Fuertes Valencia, Almudena Hernández Vázquez, Carmen Jiménez Velado, Carmen Afonso Navarro, Ana D. Dorta León, Blanca González González, Jose M. Afonso Luis, María J. García Roger, Antonia M. Pérez Cejas, Luz M. Pérez Hernández, José M. Salamanca Hernández, Rosa M. Suárez Díaz, Miguel Pico Picos, Dácil Díaz Gómez

Open Access Study protocol

A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)

Louise K. Hoeffding, Maria Haahr Nielsen, Morten A. Rasmussen, Anne Norup, Juan Carlos Arango-Lasprilla, Ulrikka K. Kjær, Kristoffer Sølvsten Burgdorf, Kirsten Jensen Quas, Trine Schow

Open Access Study protocol

Prevention of diabetes in overweight/obese children through a family based intervention program including supervised exercise (PREDIKID project): study protocol for a randomized controlled trial

Lide Arenaza, María Medrano, María Amasene, Beatriz Rodríguez-Vigil, Ignacio Díez, Manuel Graña, Ignacio Tobalina, Edurne Maiz, Edurne Arteche, Eider Larrarte, Inge Huybrechts, Catherine L. Davis, Jonatan R. Ruiz, Francisco B. Ortega, Javier Margareto, Idoia Labayen

Open Access Study protocol

Effects of intraoperative PEEP optimization on postoperative pulmonary complications and the inflammatory response: study protocol for a randomized controlled trial

Zoltán Ruszkai, Erika Kiss, Ildikó László, Fanni Gyura, Erika Surány, Péter Töhötöm Bartha, Gergely Péter Bokrétás, Edit Rácz, István Buzogány, Zoltán Bajory, Erzsébet Hajdú, Zsolt Molnár

Open Access Study protocol

The influence of 3 months of physical exercises and verbal stimulation on functional efficiency and use of free time in an older population under institutional care: study protocol for a randomized controlled trial

Agnieszka Wiśniowska-Szurlej, Agnieszka Ćwirlej-Sozańska, Anna Wilmowska-Pietruszyńska, Natalia Milewska, Bernard Sozański

Open Access Study protocol

Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial

Babalola Faseru, Edward F. Ellerbeck, Delwyn Catley, Byron J. Gajewski, Taneisha S. Scheuermann, Theresa I. Shireman, Laura M. Mussulman, Niaman Nazir, Terry Bush, Kimber P. Richter

Open Access Methodology

Understanding the cluster randomised crossover design: a graphical illustration of the components of variation and a sample size tutorial

Sarah J. Arnup, Joanne E. McKenzie, Karla Hemming, David Pilcher, Andrew B. Forbes

Open Access Study protocol

Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials

Nadja Kehler Curth, Ursula Ødum Brinck-Claussen, Annette Sofie Davidsen, Marianne Engelbrecht Lau, Merete Lundsteen, John Hagel Mikkelsen, Claudio Csillag, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov

Open Access Study protocol

Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland’s public sector health system: study protocol for a stepped-wedge randomized trial

Fiona J. Walsh, Till Bärnighausen, Wim Delva, Yvette Fleming, Gavin Khumalo, Charlotte L. Lejeune, Sikhathele Mazibuko, Charmaine Khudzie Mlambo, Ria Reis, Donna Spiegelman, Mandisa Zwane, Velephi Okello

Open Access Study protocol

High-speed resistance training and balance training for people with knee osteoarthritis to reduce falls risk: study protocol for a pilot randomized controlled trial

Pazit Levinger, Jeremy Dunn, Nancy Bifera, Michael Butson, George Elias, Keith D. Hill

Open Access Study protocol

Oral hygiene in intensive care unit patients with photodynamic therapy: study protocol for randomised controlled trial

Gabriela Alves Da Collina, Anna Carolina Ratto Tempestini-Horliana, Daniela de Fátima Teixeira da Silva, Priscila Larcher Longo, Maria Luisa Faria Makabe, Christiane Pavani

Open Access Study protocol

Assessment of ibrutinib plus rituximab in front-line CLL (FLAIR trial): study protocol for a phase III randomised controlled trial

Laura Collett, Dena R. Howard, Talha Munir, Lucy McParland, Jamie B. Oughton, Andy C. Rawstron, Anna Hockaday, Claire Dimbleby, David Phillips, Kathryn McMahon, Claire Hulme, David Allsup, Adrian Bloor, Peter Hillmen

Open Access Research

Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access

G. A. Powell, L. J. Bonnett, C. Tudur-Smith, D. A. Hughes, P. R. Williamson, A. G. Marson

Open Access Study protocol

Perioperative antibiotic prophylaxis in the treatment of acute cholecystitis (PEANUTS II trial): study protocol for a randomized controlled trial

Charlotte S. Loozen, Hjalmar C. van Santvoort, Antoinette A. W. van Geloven, Grard A. P. Nieuwenhuijzen, Philip R. de Reuver, Mark H. G. Besselink, Bart Vlaminckx, Johannes C. Kelder, Catherijne A. J. Knibbe, Djamila Boerma

Open Access Update

The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP)

Fiona Boland, Michael Quirke, Brenda Gannon, Sinead Plunkett, John Hayden, John McCourt, Ronan O’Sullivan, Joseph Eustace, Conor Deasy, Abel Wakai

Open Access Study protocol

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (HAND-1): study protocol for a randomised controlled trial

Eleanor Harrison, Wei Tan, Nicola Mills, Alexia Karantana, Kirsty Sprange, Lelia Duley, Daisy Elliott, Jane Blazeby, William Hollingworth, Alan A. Montgomery, Tim Davis

Open Access Research

A large cluster randomized trial of outcome-based pathways to improve home-based wound care

Merrick Zwarenstein, Salimah Shariff, Nicole Mittmann, Anita Stern, Katie N. Dainty

Open Access Study protocol

A rectal cancer feasibility study with an embedded phase III trial design assessing magnetic resonance tumour regression grade (mrTRG) as a novel biomarker to stratify management by good and poor response to chemoradiotherapy (TRIGGER): study protocol for a randomised controlled trial

Nick J. Battersby, Mit Dattani, Sheela Rao, David Cunningham, Diana Tait, Richard Adams, Brendan J. Moran, Shelize Khakoo, Paris Tekkis, Shahnawaz Rasheed, Alex Mirnezami, Philip Quirke, Nicholas P. West, Iris Nagtegaal, Irene Chong, Anguraj Sadanandam, Nicola Valeri, Karen Thomas, Michelle Frost, Gina Brown

Open Access Study protocol

Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial

Alieske E. H. Dam, Marjolein E. de Vugt, Martin P. J. van Boxtel, Frans R. J. Verhey

Open Access Study protocol

Effects of a brief, pedometer-based behavioral intervention for individuals with COPD during inpatient pulmonary rehabilitation on 6-week and 6-month objectively measured physical activity: study protocol for a randomized controlled trial

Wolfgang Geidl, Jana Semrau, René Streber, Nicola Lehbert, Silke Wingart, Alexander Tallner, Michael Wittmann, Rupert Wagner, Konrad Schultz, Klaus Pfeifer

Open Access Study protocol

The PD COMM trial: a protocol for the process evaluation of a randomised trial assessing the effectiveness of two types of SLT for people with Parkinson’s disease

Patricia Masterson-Algar, Christopher R. Burton, Marian C. Brady, Avril Nicoll, Carl E. Clarke, Caroline Rick, Max Hughes, Pui Au, Christina H. Smith, Catherine M. Sackley

Open Access Study protocol

Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial

Rebecca Asadpour, Kerstin A. Kessel, Tom Bruckner, Serkan Sertel, Stephanie E. Combs

Open Access Study protocol

REstricted Fluid REsuscitation in Sepsis-associated Hypotension (REFRESH): study protocol for a pilot randomised controlled trial

Stephen P. J. Macdonald, David McD Taylor, Gerben Keijzers, Glenn Arendts, Daniel M. Fatovich, Frances B. Kinnear, Simon G. A. Brown, Rinaldo Bellomo, Sally Burrows, John F. Fraser, Edward Litton, Juan Carlos Ascencio-Lane, Matthew Anstey, David McCutcheon, Lisa Smart, Ioana Vlad, James Winearls, Bradley Wibrow

Open Access Study protocol

Influence of motor skills training on children’s development evaluated in the Motor skills in PreSchool (MiPS) study-DK: study protocol for a randomized controlled trial, nested in a cohort study

Lise Hestbaek, Sarah Thurøe Andersen, Thomas Skovgaard, Line Groenholt Olesen, Mette Elmose, Dorthe Bleses, Simon Calmar Andersen, Henrik Hein Lauridsen

Open Access Study protocol

A mixed-methods feasibility and external pilot study to inform a large pragmatic randomised controlled trial of the effects of surgical wound dressing strategies on surgical site infections (Bluebelle Phase B): study protocol for a randomised controlled trial

Barnaby C. Reeves, Lazaros Andronis, Jane M. Blazeby, Natalie S. Blencowe, Melanie Calvert, Joanna Coast, Tim Draycott, Jenny L. Donovan, Rachael Gooberman-Hill, Robert J. Longman, Laura Magill, Jonathan M. Mathers, Thomas D. Pinkney, Chris A. Rogers, Leila Rooshenas, Andrew Torrance, Nicky J. Welton, Mark Woodward, Kate Ashton, Katarzyna D. Bera, Gemma L. Clayton, Lucy A. Culliford, Jo C. Dumville, Daisy Elliott, Lucy Ellis, Hannah Gould-Brown, Rhiannon C. Macefield, Christel McMullan, Caroline Pope, Dimitrios Siassakos, Sean Strong, Helen Talbot

Open Access Study protocol

Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial

Roderick W. Treskes, Willem Gielen, Marieke J. Wermer, Robert W. Grauss, Anouk P. van Alem, Reza Alizadeh Dehnavi, Charles J. Kirchhof, Enno T. van der Velde, Arie C. Maan, Ron Wolterbeek, Onno M. Overbeek, Martin J. Schalij, Serge A. Trines

Open Access Study protocol

Ultra-low dose of rituximab in rheumatoid arthritis: study protocol for a randomised controlled trial

Alfons A. den Broeder, Lise M. Verhoef, Jaap Fransen, Rogier Thurlings, Bart J. F. van den Bemt, Steven Teerenstra, Nadine Boers, Nathan den Broeder, Frank H. J. van den Hoogen

Open Access Study protocol

Synergistic effects of aerobic exercise and cognitive training on cognition, physiological markers, daily function, and quality of life in stroke survivors with cognitive decline: study protocol for a randomized controlled trial

Ting-ting Yeh, Ching-yi Wu, Yu-wei Hsieh, Ku-chou Chang, Lin-chien Lee, Jen-wen Hung, Keh-chung Lin, Ching-hung Teng, Yi-han Liao

Open Access Research

Identifying research priorities for effective retention strategies in clinical trials

Anna Kearney, Anne Daykin, Alison R. G. Shaw, Athene J. Lane, Jane M. Blazeby, Mike Clarke, Paula Williamson, Carrol Gamble

Open Access Erratum

Erratum to Development of a core outcome set for orthodontic trials using a mixed-methods approach: protocol for a multicentre study

Aliki Tsichlaki, Kevin O’Brien, Ama Johal, Zoe Z. Marshman, Philip P. Benson, Fiorella B. Colonio Salazar, Padhraig S. Fleming

Open Access Erratum

Erratum to: Thermotherapy. An alternative for the treatment of American cutaneous leishmaniasis

Liliana López, Martha Robayo, Margarita Vargas, Iván D. Vélez

Open Access Study protocol

Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial

Zhibao Mi, Kousick Biswas, J. Kaci Fairchild, Anne Davis-Karim, Ciaran S. Phibbs, Steven D. Forman, Michael Thase, Gerald Georgette, Tamara Beale, David Pittman, Margaret Windy McNerney, Allyson Rosen, Grant D. Huang, Mark George, Art Noda, Jerome A. Yesavage

Open Access Study protocol

Intraoperative wound irrigation to prevent surgical site infection after laparotomy (IOWISI): study protocol for a randomized controlled trial

Tara C. Mueller, Ulrich Nitsche, Victoria Kehl, Rebekka Schirren, Beate Schossow, Ruediger Goess, Helmut Friess, Daniel Reim

Open Access Study protocol

Effect of maternal vitamin D3 supplementation on maternal health, birth outcomes, and infant growth among HIV-infected Tanzanian pregnant women: study protocol for a randomized controlled trial

Christopher R. Sudfeld, Karim P. Manji, Christopher P. Duggan, Said Aboud, Alfa Muhihi, David M. Sando, Fadhlun M. Alwy Al-beity, Molin Wang, Wafaie W. Fawzi

Open Access Study protocol

Improving diets and nutrition through an integrated poultry value chain and nutrition intervention (SELEVER) in Burkina Faso: study protocol for a randomized trial

Aulo Gelli, Elodie Becquey, Rasmane Ganaba, Derek Headey, Melissa Hidrobo, Lieven Huybregts, Hans Verhoef, Romain Kenfack, Sita Zongouri, Hannah Guedenet

Open Access Study protocol

Effect of an intensive nutrition intervention of a high protein and low glycemic-index diet on weight of kidney transplant recipients: study protocol for a randomized clinical trial

Elis Forcellini Pedrollo, Bruna Bellincanta Nicoletto, Larissa Salomoni Carpes, Júlia de Melo Cardoso de Freitas, Julia Roberta Buboltz, Cristina Carra Forte, Andrea Carla Bauer, Roberto Ceratti Manfro, Gabriela Corrêa Souza, Cristiane Bauermann Leitão

Open Access Erratum

Erratum to: A manual-based vocational rehabilitation program for patients with an acquired brain injury: study protocol of a pragmatic randomized controlled trial (RCT)

Louise K. Hoeffding, Maria Haahr Nielsen, Morten A. Rasmussen, Anne Norup, Juan Carlos Arango-Lasprilla, Ulrikka K. Kjær, Kristoffer Sølvsten Burgdorf, Kirsten Jensen Quas, Trine Schow

Open Access Study protocol

Jigsaw Puzzles As Cognitive Enrichment (PACE) - the effect of solving jigsaw puzzles on global visuospatial cognition in adults 50 years of age and older: study protocol for a randomized controlled trial

Patrick Fissler, Olivia C. Küster, Laura S. Loy, Daria Laptinskaya, Martin J. Rosenfelder, Christine A. F. von Arnim, Iris-Tatjana Kolassa

Open Access Methodology

Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India

Jonathon D. Gass Jr., Anamika Misra, Mahendra Nath Singh Yadav, Fatima Sana, Chetna Singh, Anup Mankar, Brandon J. Neal, Jennifer Fisher-Bowman, Jenny Maisonneuve, Megan Marx Delaney, Krishan Kumar, Vinay Pratap Singh, Narender Sharma, Atul Gawande, Katherine Semrau, Lisa R. Hirschhorn

Open Access Erratum

Erratum to: Attention training for infants at familial risk of ADHD (INTERSTAARS): study protocol for a randomised controlled trial

Amy Goodwin, Simona Salomone, Patrick Bolton, Tony Charman, Emily J.H. Jones, Luke Mason, Andrew Pickles, Emily Robinson, Tim Smith, Edmund J.S. Sonuga-Barke, Sam Wass, Mark H. Johnson

Open Access Methodology

Bayesian dose selection design for a binary outcome using restricted response adaptive randomization

Caitlyn Meinzer, Renee Martin, Jose I. Suarez

Open Access Study protocol

Uva-ursi extract and ibuprofen as alternative treatments of adult female urinary tract infection (ATAFUTI): study protocol for a randomised controlled trial

Jeanne Trill, Catherine Simpson, Frances Webley, Mike Radford, Louise Stanton, Tom Maishman, Angeliki Galanopoulou, Andrew Flower, Caroline Eyles, Merlin Willcox, Alastair Hay, Gareth Griffiths, Paul Little, George Lewith, Michael Moore

Open Access Research

Women’s views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

Alexandra Sawyer, Celine Chhoa, Susan Ayers, Angela Pushpa-Rajah, Lelia Duley

Open Access Research

Perceived barriers and facilitators to Risk Based Monitoring in academic-led clinical trials: a mixed methods study

Caroline Hurley, Carol Sinnott, Mike Clarke, Patricia Kearney, Emmy Racine, Joseph Eustace, Frances Shiely

Open Access Study protocol

MOnitored supplementation of VItamin D in preterm infants (MOSVID trial): study protocol for a randomised controlled trial

Alicja Kołodziejczyk, Maria K. Borszewska-Kornacka, Joanna Seliga-Siwecka

Open Access Review

Evidence-based practice within nutrition: what are the barriers for improving the evidence and how can they be dealt with?

Martine Laville, Berenice Segrestin, Maud Alligier, Cristina Ruano-Rodríguez, Lluis Serra-Majem, Michael Hiesmayr, Annemie Schols, Carlo La Vecchia, Yves Boirie, Ana Rath, Edmund A. M. Neugebauer, Silvio Garattini, Vittorio Bertele, Christine Kubiak, Jacques Demotes-Mainard, Janus C. Jakobsen, Snezana Djurisic, Christian Gluud

Open Access Study protocol

The effect of information about the benefits and harms of mammography on women’s decision-making: study protocol for a randomized controlled trial

Misericòrdia Carles, Montserrat Martínez-Alonso, Anna Pons, Maria José Pérez-Lacasta, Lilisbeth Perestelo-Pérez, Maria Sala, Carmen Vidal, Montse Garcia, Ana Toledo-Chávarri, Núria Codern, Maria Feijoo-Cid, Anabel Romero, Roger Pla, Jorge Soler-González, Xavier Castells, Montserrat Rué, Àngels Cardona, Núria Codern, Lilisbeth Perestelo-Pérez, Ana Toledo, Maria Feijoo, Montse Garcia, Carmen Vidal, Sara Buil, Clara Viñals, Laia Viñals, Montserrat Martínez-Alonso, Marta Ortega, Sandra Pla, Anna Pons-Rodríguez, Montserrat Rué, Jorge Soler, Misericòrdia Carles, Maria José Pérez, Roger Pla, Andrea Burón, Xavier Castells, Anabel Romero, Maria Sala

Open Access Review

Specific barriers to the conduct of randomised clinical trials on medical devices

Edmund A. M. Neugebauer, Ana Rath, Sunya-Lee Antoine, Michaela Eikermann, Doerthe Seidel, Carsten Koenen, Esther Jacobs, Dawid Pieper, Martine Laville, Séverine Pitel, Cecilia Martinho, Snezana Djurisic, Jacques Demotes-Mainard, Christine Kubiak, Vittorio Bertele, Janus C. Jakobsen, Silvio Garattini, Christian Gluud

Open Access Study protocol

Acupuncture lowering blood pressure for secondary prevention of stroke: a study protocol for a multicenter randomized controlled trial

Yu-zheng Du, Xin-xin Gao, Cheng-Ting Wang, Hai-zhen Zheng, Yun Lei, Meng-han Wu, Xue-min Shi, Hai-peng Ban, Wen-long Gu, Xiang-gang Meng, Mao-ti Wei, Chun-xiao Hu

Open Access Study protocol

A randomized phase II study to assess the effect of adjuvant immunotherapy using α-GalCer-pulsed dendritic cells in the patients with completely resected stage II–IIIA non-small cell lung cancer: study protocol for a randomized controlled trial

Hideo Saka, Chiyoe Kitagawa, Yukito Ichinose, Mitsuhiro Takenoyama, Hidenori Ibata, Tatsuo Kato, Koji Takami, Motohiro Yamashita, Tadashi Maeda, Sadanori Takeo, Hitoshi Ueda, Kan Okabayashi, Seiji Nagashima, Tadayuki Oka, Hidenori Kouso, Seiichi Fukuyama, Kentaro Yoshimoto, Mototsugu Shimokawa, Akiko M. Saito, Suminobu Ito

Open Access Study protocol

TIGA-CUB – manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5–11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial

Elizabeth Edginton, Rebecca Walwyn, Kayleigh Burton, Robert Cicero, Liz Graham, Sadie Reed, Sandy Tubeuf, Maureen Twiddy, Alex Wright-Hughes, Lynda Ellis, Dot Evans, Tom Hughes, Nick Midgley, Paul Wallis, David Cottrell

Open Access Study protocol

Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial

Sudhin Thayyil, Vania Oliveira, Peter J. Lally, Ravi Swamy, Paul Bassett, Mani Chandrasekaran, Jayashree Mondkar, Sundaram Mangalabharathi, Naveen Benkappa, Arasar Seeralar, Mohammod Shahidullah, Paolo Montaldo, Jethro Herberg, Swati Manerkar, Kumutha Kumaraswami, Chinnathambi Kamalaratnam, Vinayagam Prakash, Rema Chandramohan, Prathik Bandya, Mohammod Abdul Mannan, Ranmali Rodrigo, Mohandas Nair, Siddarth Ramji, Seetha Shankaran, Seetha Shankaran, Gaurav Atreja, Mani Chandrasekaran, Jethro Herberg, Pete Lally, Josephine Mendoza, Paolo Montaldo, Vania Oliveira, Ravi Swamy, Sudhin Thayyil, Neil Sebire, Nigel Klein, Kshitij Mankad, Arjun Chandra Dey, Sanjoy Kumer Dey, Mohammed Tariqul Islam, Ismat Jahan, Mohammed Abdul Mannan, Sadeka Chowdhury Moni, Kamrul Hasan Shabuj, Mohammod Shahidullah, Mohammed Nazrul Islam, Mst. Nazmun Nahar, Ashish Jain, Siddarth Ramji, Swati Manerkar, Jayashree Mondkar, Kapil Dewang, Swapnil Bhiskar, Chinnathambi Kamalaratnam, Kumutha Kumaraswami, Sundaram Mangalabharathi, Padmesh Vadekepad, Monica Sebastian, Naveen Benkappa, Prathik Bandya, Usha Kantharajanna, Sowmya Krishnappa, Jagdish Somanna, Niranjan Hunsanhalli Shivanna, Arasar Seeralar, Vinayagam Prakash, Mythilli Babu, Mohamed Sajjid, Babu Peter Sathyanathan, Kailasanathan Natarajan, Senthil Kumaran, Anusha Rohit, Indrani Karunasagar, Vijaykumar Madhavan, Mohandas Nair, Ranmali Rodrigo, Shaman Rajindrajith, Jithangi Wanigasinghe, Samanmali Sumanasena, Radika Karunaratne, Sanjeewa Munasinghe, Kalpani Chathirangika

Open Access Study protocol

A primary school active break programme (ACTI-BREAK): study protocol for a pilot cluster randomised controlled trial

Amanda Watson, Anna Timperio, Helen Brown, Kylie D. Hesketh

Open Access Study protocol

A cluster-randomized trial to reduce major perinatal morbidity among women with one prior cesarean delivery in Québec (PRISMA trial): study protocol for a randomized controlled trial

N. Chaillet, E. Bujold, B. Masse, W. A. Grobman, P. Rozenberg, J. C. Pasquier, A. Shorten, M. Johri, F. Beaudoin, H. Abenhaim, S. Demers, W. Fraser, M. Dugas, S. Blouin, E. Dubé, R. Gauthier, Nils Chaillet, Emmanuel Bujold, Suzanne Demers, Marylène Dugas, Bruno Piedboeuf, Mira Johri, François Beaudoin, Robert Gauthier, Benoit Masse, François Audibert, Louise Duperron, Marie Josée Bédard, François Champagne, Diane Francoeur, William D. Fraser, Jean-Charles Pasquier, Haim Abenhaim, Robert Gagnon, Patricia Monnier, Isabelle Girard, Guy-Paul Gagné, William A. Grobman, Allison Shorten, Patrick Rozenberg, Jennifer Blake, Isabelle Girard, Diane Francoeur, Andrée Gagnon, Luisa Ciofani, Marie-Eve St Laurent, Daniel Riverin, Benoit Masse, Eric Dubé, Simon Blouin, Robert Platt, Shiliang Liu, Fernando Althabe

Open Access Study protocol

Topiramate’s effectiveness on weight reduction in overweight/obese persons with schizophrenia: study protocol for a randomized controlled trial

Miyuru Chandradasa, Layani Champika, Silumini de Silva, K. A. L. A. Kuruppuarachchi

Open Access Study protocol

Core outcomes in periodontal trials: study protocol for core outcome set development

Thomas J. Lamont, Jan E. Clarkson, David N. J. Ricketts, Peter A. Heasman, Craig R. Ramsay

Open Access Study protocol

Effectiveness of an interactive telerehabilitation system with home-based exercise training in patients after total hip or knee replacement: study protocol for a multicenter, superiority, no-blinded randomized controlled trial

Sarah Eichler, Sophie Rabe, Annett Salzwedel, Steffen Müller, Josefine Stoll, Nina Tilgner, Michael John, Karl Wegscheider, Frank Mayer, Heinz Völler

Open Access Study protocol

SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial

Sanghyun Ahn, Joongyub Lee, Seung-Kee Min, Jongwon Ha, Sang-il Min, Song-Yi Kim, Min-Ji Cho, Sungsin Cho

Open Access Commentary

Conducting non-commercial international clinical trials: the ICR-CTSU experience

Lisa Fox, Christy Toms, Sarah Kernaghan, Claire Snowdon, Judith M. Bliss

Open Access Study protocol

General practitioner use of a C-reactive protein point-of-care test to help target antibiotic prescribing in patients with acute exacerbations of chronic obstructive pulmonary disease (the PACE study): study protocol for a randomised controlled trial

Janine Bates, Nick A. Francis, Patrick White, David Gillespie, Emma Thomas-Jones, Rachel Breen, Nigel Kirby, Kerry Hood, Micaela Gal, Rhiannon Phillips, Gurudutt Naik, Jochen Cals, Carl Llor, Hasse Melbye, Mandy Wootton, Evgenia Riga, Ann Cochrane, Robin Howe, Deborah Fitzsimmons, Bernadette Sewell, Mohammed Fasihul Alam, Christopher C. Butler

Open Access Study protocol

Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial

Marleen Kunneman, Megan E. Branda, Peter A. Noseworthy, Mark Linzer, Bruce Burnett, Sara Dick, Gabriela Spencer-Bonilla, Cara A. Fernandez, Haeshik Gorr, Mike Wambua, Shelly Keune, Claudia Zeballos-Palacios, Ian Hargraves, Nilay D. Shah, Victor M. Montori

Open Access Research

Clinical features of Parkinson’s disease patients are associated with therapeutic misconception and willingness to participate in clinical trials

Emmi Reijula, Anna-Maija Pietilä, Arja Halkoaho, Tuomas Selander, Kirsti Martikainen, Reetta Kälviäinen, Tapani Keränen

Open Access Study protocol

TAILOR – tapered discontinuation versus maintenance therapy of antipsychotic medication in patients with newly diagnosed schizophrenia or persistent delusional disorder in remission of psychotic symptoms: study protocol for a randomized clinical trial

Anne Emilie Stürup, Heidi Dorthe Jensen, Signe Dolmer, Merete Birk, Nikolai Albert, Mai Nielsen, Carsten Hjorthøj, Lene Eplov, Bjørn H. Ebdrup, Ole Mors, Merete Nordentoft

Open Access Study protocol

Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: study protocol for a randomized controlled trial

Priyanga Ranasinghe, Priyadarshani Galappaththy, Godwin Roger Constantine, Ranil Jayawardena, Hasitha Dhananjaya Weeratunga, Sirimal Premakumara, Prasad Katulanda

Open Access Study protocol

Crowdsourcing to promote HIV testing among MSM in China: study protocol for a stepped wedge randomized controlled trial

Barry Bayus, Bolin Cao, Zihuang Chen, Maya Durvasula, Kevin Fenton, Rong Fu, David Glidden, Larry Han, Lisa Hightow-Weidman, Wenqi Hu, Shujie Huang, Michael Hudgens, Dianmin Kang, Haochu Li, Meizhen Liao, Chuncheng Liu, Wei Ma, Jessica Mao, Kate Mitchell, Katie Mollan, Jason Ong, Stephen Pan, Rosanna Peeling, Yilu Qin, Adam Saffer, Kumi Smith, Gabriella Stein, Songyuan Tang, Weiming Tang, Fern Terris-Prestholt, Joseph D. Tucker, Peter Vickerman, Cheng Wang, Chongyi Wei, Li Xue, Bin Yang, Ligang Yang, Wei Zhang, Tiange P. Zhang, Ye Zhang, Heping Zheng, Joseph D. Tucker

Open Access Study protocol

Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial

Dziedzom K. de Souza, Collins S. Ahorlu, Susan Adu-Amankwah, Joseph Otchere, Sedzro K. Mensah, Irene A. Larbi, George E. Mensah, Nana-Kwadwo Biritwum, Daniel A. Boakye

Open Access Commentary

Health research participants are not receiving research results: a collaborative solution is needed

Christopher R. Long, M. Kathryn Stewart, Pearl A. McElfish

Open Access Study protocol

Co-trimoxazole versus azithromycin for the treatment of undifferentiated febrile illness in Nepal: study protocol for a randomized controlled trial

Sunil Pokharel, Buddha Basnyat, Amit Arjyal, Saruna Pathak Mahat, Raj Kumar KC, Abhusani Bhuju, Buddhi Poudyal, Evelyne Kestelyn, Ritu Shrestha, Dung Nguyen Thi Phuong, Rajkumar Thapa, Manan Karki, Sabina Dongol, Abhilasha Karkey, Marcel Wolbers, Stephen Baker, Guy Thwaites

Open Access Study protocol

The long-term effect of acupuncture for patients with chronic tension-type headache: study protocol for a randomized controlled trial

Lingyun Lu, Hui Zheng, Qianhua Zheng, Xinyu Hao, Siyuan Zhou, Shusen Zhang, Tao Wei, Tao Gao, Duoxi Duan, Ling Zhao, Ning Li, Ying Li

Open Access Study protocol

An intervention delivered by text message to increase the acceptability of effective contraception among young women in Palestine: study protocol for a randomised controlled trial

Ona L McCarthy, Ola Wazwaz, Iman Jado, Baptiste Leurent, Phil Edwards, Samia Adada, Amina Stavridis, Caroline Free

Open Access Update

Statistical analysis plan for the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM)

Grace J. Young, Amanda L. Lewis, J. Athene Lane, Helen L. Winton, Marcus J. Drake, Peter S. Blair

Open Access Study protocol

The ExPeCT (Examining Exercise, Prostate Cancer and Circulating Tumour Cells) trial: study protocol for a randomised controlled trial

Gráinne Sheill, Lauren Brady, Emer Guinan, Brian Hayes, Orla Casey, John Greene, Tatjana Vlajnic, Fidelma Cahill, Mieke Van Hemelrijck, Nicola Peat, Sarah Rudman, Juliette Hussey, Moya Cunningham, Liam Grogan, Thomas Lynch, Rustom P. Manecksha, John McCaffrey, Lorelei Mucci, Orla Sheils, John O’Leary, Dearbhaile M. O’Donnell, Ray McDermott, Stephen Finn

Open Access Research

Central venous Access device SeCurement And Dressing Effectiveness for peripherally inserted central catheters in adult acute hospital patients (CASCADE): a pilot randomised controlled trial

Raymond J. Chan, Sarah Northfield, Emily Larsen, Gabor Mihala, Amanda Ullman, Peter Hancock, Nicole Marsh, Nicole Gavin, David Wyld, Anthony Allworth, Emily Russell, Md Abu Choudhury, Julie Flynn, Claire M. Rickard

Open Access Study protocol

Effects of action observation therapy and mirror therapy after stroke on rehabilitation outcomes and neural mechanisms by MEG: study protocol for a randomized controlled trial

Tsai-yu Shih, Ching-yi Wu, Keh-chung Lin, Chia-hsiung Cheng, Yu-wei Hsieh, Chia-ling Chen, Chih-jou Lai, Chih-chi Chen

Open Access Study protocol

Efficacy and safety of a balanced salt solution versus a 0.9% saline infusion for the prevention of contrast-induced acute kidney injury (BASIC trial): a study protocol for a randomized controlled trial

Hyung Ah Jo, Sehoon Park, Chan-Duck Kim, Hee-Yeon Jung, Jang-Hee Cho, Ran-hui Cha, Ea Wha Kang, Tae Ik Chang, Sejoong Kim, Hyung-Jong Kim, Byung Ha Chung, Jung Pyo Lee, Jung Tak Park, Seung Hyeok Han, Tae-Hyun Yoo, Dong-Ryeol Ryu, Sung Jin Moon, Jae Hyun Chang, Dong Ki Kim, Kwon Wook Joo

Open Access Study protocol

COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial

Oye Gureje, Victor Makanjuola, Lola Kola, Bidemi Yusuf, Leshawndra Price, Oluyomi Esan, Bibilola D. Oladeji, John Appiah-Poku, Benjamin Haris, Caleb Othieno, Soraya Seedat

Open Access Study protocol

Development of an infant feeding core outcome set for childhood obesity interventions: study protocol

Karen Matvienko-Sikar, Molly Byrne, Colette Kelly, Elaine Toomey, Marita Hennessy, Declan Devane, Caroline Heary, Janas Harrington, Niamh McGrath, Michelle Queally, Patricia M. Kearney

Open Access Research

Mechanical wrist traction as a non-invasive treatment for carpal tunnel syndrome: a randomized controlled trial

Margreet Meems, Viola Spek, Willem J. Kop, Berend-Jan Meems, Leo H. Visser, Victor J. M. Pop

Open Access Update

PANSAID—PAracetamol and NSAID in combination: detailed statistical analysis plan for a randomised, blinded, parallel, four-group multicentre clinical trial

Kasper Højgaard Thybo, Janus Christian Jakobsen, Daniel Hägi-Pedersen, Niels Anker Pedersen, Jørgen Berg Dahl, Henrik Morville Schrøder, Hans Henrik Bülow, Jan Gottfrid Bjørck, Søren Overgaard, Ole Mathiesen, Jørn Wetterslev

Open Access Study protocol

Family Integrated Care (FICare) in Level II Neonatal Intensive Care Units: study protocol for a cluster randomized controlled trial

Karen M. Benzies, Vibhuti Shah, Khalid Aziz, Wanrudee Isaranuwatchai, Luz Palacio-Derflingher, Jeanne Scotland, Jill Larocque, Kelly Mrklas, Esther Suter, Christopher Naugler, Henry T. Stelfox, Radha Chari, Abhay Lodha

Open Access Study protocol

Safety and efficacy of Qishen granules in patients with chronic heart failure: study protocol for a randomized controlled trial

Jinping Wang, Jun Shi, Jiawei Wei, Juan Wang, Kuo Gao, Xueli Li, Jianxin Chen, Shaojing Li, Huihui Zhao, Wei Wang

Open Access Study protocol

The LeucoPatch® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomised controlled trial

Frances Game, William Jeffcoate, Lise Tarnow, Florence Day, Deborah Fitzsimmons, Judith Jacobsen

Open Access Study protocol

The Swedish study of Irrigation-fluid temperature in the evacuation of Chronic subdural hematoma (SIC!): study protocol for a multicenter randomized controlled trial

Andreas Bartley, Asgeir S. Jakola, Jiri Bartek Jr, Jimmy Sundblom, Petter Förander, Niklas Marklund, Magnus Tisell

Open Access Study protocol

Sedation with propofol during ERCP: is the combination with esketamine more effective and safer than with alfentanil? Study protocol for a randomized controlled trial

Susanne Eberl, Lena Koers, Jeanin E. van Hooft, Edwin de Jong, Thomas Schneider, Markus W. Hollmann, Benedikt Preckel

Open Access Study protocol

CXCR2 Inhibition – a novel approach to treating CoronAry heart DiseAse (CICADA): study protocol for a randomised controlled trial

Jubin P. Joseph, Eliana Reyes, Josephine Guzman, Jim O’Doherty, Hannah McConkey, Satpal Arri, Rahul Kakkar, Nicholas Beckley, Abdel Douiri, Sally F. Barrington, Simon R. Redwood, Albert Ferro

Open Access Research

Willingness to participate in pragmatic dialysis trials: the importance of physician decisional autonomy and consent approach

Katherine R. Courtright, Scott D. Halpern, Steven Joffe, Susan S. Ellenberg, Jason Karlawish, Vanessa Madden, Nicole B. Gabler, Stephanie Szymanski, Kuldeep N. Yadav, Laura M. Dember

Open Access Study protocol

The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial

Victoria Hardy, Yvonne O’Connor, Ciara Heavin, Nikolaos Mastellos, Tammy Tran, John O’Donoghue, Annette L. Fitzpatrick, Nicole Ide, Tsung-Shu Joseph Wu, Griphin Baxter Chirambo, Adamson S. Muula, Moffat Nyirenda, Sven Carlsson, Bo Andersson, Matthew Thompson

Open Access Study protocol

Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial

Risa Hoffman, Ashley Bardon, Sydney Rosen, Matthew Fox, Thoko Kalua, Thembi Xulu, Angela Taylor, Ian Sanne

Open Access Study protocol

Efficacy differences of electroacupuncture with single acupoint or matching acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial

Bo Chen, Yang Guo, Xue Zhao, Li-li Gao, Bo Li, Tian-yi Zhao, Qi-wen Zhang, Jin-xing Zou, Ming-yue Li, Yong-ming Guo, Yi Guo, Xing-fan Pan

Open Access Study protocol

Evaluating a multi-component, community-based program to improve adherence and retention in care among adolescents living with HIV in Zimbabwe: study protocol for a cluster randomized controlled trial

Webster Mavhu, Nicola Willis, Juliet Mufuka, Collin Mangenah, Kudzanayi Mvududu, Sarah Bernays, Walter Mangezi, Tsitsi Apollo, Ricardo Araya, Helen A. Weiss, Frances M. Cowan

Open Access Study protocol

Xingnaojing for Moderate-to-severe Acute ischemic Stroke (XMAS): study protocol for a randomized controlled trial

Xinxing Lai, Kegang Cao, Lingbo Kong, Qiang Liu, Ying Gao

Open Access Study protocol

The efficacy and stability of an information and communication technology-based centralized monitoring system of adherence to immunosuppressive medication in kidney transplant recipients: study protocol for a randomized controlled trial

Hee-Yeon Jung, Sook Jin Seong, Ji-Young Choi, Jang-Hee Cho, Sun-Hee Park, Chan-Duck Kim, Young-Ran Yoon, Hyung-Kee Kim, Seung Huh, Se-Hee Yoon, Jong Soo Lee, Yong-Lim Kim

Open Access Correction

Correction to: Anti-inflammatory and immune regulatory effects of acupuncture after craniotomy: study protocol for a parallel-group randomized controlled trial

Seung-Yeon Cho, Seung-Bo Yang, Hee Sup Shin, Seung Hwan Lee, Jun Seok Koh, Seungwon Kwon, Woo-Sang Jung, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko, Seong-Uk Park

Open Access Study protocol

Combined cognitive and vocational interventions after mild to moderate traumatic brain injury: study protocol for a randomized controlled trial

Emilie I. Howe, Knut-Petter S. Langlo, Hans Christoffer Aargaard Terjesen, Cecilie Røe, Anne-Kristine Schanke, Helene L. Søberg, Unni Sveen, Eline Aas, Heidi Enehaug, Daniele E. Alves, Pål Klethagen, Kjersti Sagstad, Christine M. Moen, Karin Torsteinsbrend, Anne-Margrethe Linnestad, Tonje Haug Nordenmark, Birte Sand Rismyhr, Grete Wangen, Juan Lu, Jennie Ponsford, Elizabeth W. Twamley, Helene Ugelstad, Øystein Spjelkavik, Marianne Løvstad, Nada Andelic

Open Access Study protocol

The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial

Ben Darlow, James Stanley, Sarah Dean, J. Haxby Abbott, Sue Garrett, Fiona Mathieson, Anthony Dowell

Open Access Study protocol

The efficacy of the Kampo medicine rikkunshito for chemotherapy-induced anorexia (RICH trial): study protocol for a randomized controlled trial

Takuya Inoue, Hironori Takagi, Yuki Owada, Yuzuru Watanabe, Takumi Yamaura, Mitsuro Fukuhara, Satoshi Muto, Naoyuki Okabe, Yuki Matsumura, Takeo Hasegawa, Jun Osugi, Mika Hoshino, Mitsunori Higuchi, Yutaka Shio, Hiroshi Yokouchi, Kenya Kanazawa, Katsuya Ohbuchi, Takahisa Fukushima, Mitsuru Munakata, Hiroyuki Suzuki

Open Access Study protocol

iTACTIC – implementing Treatment Algorithms for the Correction of Trauma-Induced Coagulopathy: study protocol for a multicentre, randomised controlled trial

Kjersti Baksaas-Aasen, Lewis Gall, Simon Eaglestone, Claire Rourke, Nicole. P. Juffermans, J. Carel Goslings, Paal Aksel Naess, Susan van Dieren, Sisse Rye Ostrowski, Jakob Stensballe, Marc Maegele, Simon J. Stanworth, Christine Gaarder, Karim Brohi, Per I. Johansson

Open Access Study protocol

POWERS forID: Personalized Online Weight and Exercise Response System for Individuals with Intellectual Disability: study protocol for a randomized controlled trial

William H. Neumeier, Nichole Guerra, Mohanraj Thirumalai, Betty Geer, David Ervin, James H. Rimmer

Open Access Study protocol

Effect of strength training on sleep apnea severity in the elderly: study protocol for a randomized controlled trial

Roberto Pacheco da Silva, Denis Martinez, Pedro Lopez, Eduardo Lusa Cadore

Open Access Study protocol

Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Daniel I. Schlessinger, Sanjana Iyengar, Arianna F. Yanes, Jake M. Lazaroff, Victoria Godinez-Puig, Brian R. Chen, Anastasia O. Kurta, Jill K. Henley, Sarah G. Chiren, Karina C. Furlan, Jochen Schmitt, Stefanie Deckert, Emily Poon, Joseph F. Sobanko, Todd V. Cartee, Murad Alam, Ian A. Maher

Open Access Study protocol

A multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission

Sasha Shepperd, Andrea Cradduck-Bamford, Chris Butler, Graham Ellis, Mary Godfrey, Alastair Gray, Anthony Hemsley, Pradeep Khanna, Peter Langhorne, Patricia McCaffrey, Lubena Mirza, Maj Pushpangadan, Scott Ramsay, Rebekah Schiff, David Stott, John Young, Ly-Mee Yu

Open Access Study protocol

The Community Navigator Study: a feasibility randomised controlled trial of an intervention to increase community connections and reduce loneliness for people with complex anxiety or depression

Brynmor Lloyd-Evans, Jessica K. Bone, Vanessa Pinfold, Glyn Lewis, Jo Billings, Johanna Frerichs, Kate Fullarton, Rebecca Jones, Sonia Johnson

Open Access Study protocol

Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial

Larry W. Chang, Ismail Mbabali, Xiangrong Kong, Heidi Hutton, K. Rivet Amico, Caitlin E. Kennedy, Fred Nalugoda, David Serwadda, Robert C. Bollinger, Thomas C. Quinn, Steven J. Reynolds, Ronald Gray, Maria Wawer, Gertrude Nakigozi

Open Access Study protocol

A randomised controlled trial assessing the severity and duration of depressive symptoms associated with a clinically significant response to sertraline versus placebo, in people presenting to primary care with depression (PANDA trial): study protocol for a randomised controlled trial

George Salaminios, Larisa Duffy, Anthony Ades, Ricardo Araya, Katherine S. Button, Rachel Churchill, Tim Croudace, Catherine Derrick, Padraig Dixon, Christopher Dowrick, Simon Gilbody, William Hollingworth, Vivien Jones, Tony Kendrick, David Kessler, Daphne Kounali, Paul Lanham, Alice Malpass, Tim J. Peters, Derek Riozzie, Jude Robinson, Debbie Sharp, Laura Thomas, Nicky J. Welton, Nicola Wiles, Glyn Lewis

Open Access Study protocol

Safety of tubal ligation by minilaparotomy provided by clinical officers versus assistant medical officers: study protocol for a noninferiority randomized controlled trial in Tanzanian women

Mark A. Barone, Zuhura Mbuguni, Japhet Ominde Achola, Carmela Cordero, Joseph Kanama, Projestine S. Muganyizi, Jamilla Mwanga, Caitlin Shannon, Leopold Tibyehabwa

Open Access Research

Participant recruitment and retention in longitudinal preconception randomized trials: lessons learnt from the Calcium And Pre-eclampsia (CAP) trial

Theresa A. Lawrie, Ana Pilar Betrán, Mandisa Singata-Madliki, Alvaro Ciganda, G. Justus Hofmeyr, José M. Belizán, Tina Dannemann Purnat, Sarah Manyame, Catherine Parker, Gabriela Cormick

Open Access Study protocol

Long-term Effects of high-doSe pitavaStatin on Diabetogenicity in comparison with atorvastatin in patients with Metabolic syndrome (LESS-DM): study protocol for a randomized controlled trial

Jun-Bean Park, Ji-Hyun Jung, Yeonyee E. Yoon, Hack-Lyong Kim, Seung-Pyo Lee, Hyung-Kwan Kim, Yong-Jin Kim, Goo-Yeong Cho, Dae-Won Sohn

Open Access Study protocol

Improving oxygen therapy for children and neonates in secondary hospitals in Nigeria: study protocol for a stepped-wedge cluster randomised trial

Hamish R. Graham, Adejumoke I. Ayede, Ayobami A. Bakare, Oladapo B. Oyewole, David Peel, Amy Gray, Barbara McPake, Eleanor Neal, Shamim Qazi, Rasa Izadnegahdar, Adegoke G. Falade, Trevor Duke

Open Access Research

Lessons from the field: the conduct of randomized controlled trials in Botswana

Janice M. Bonsu, Rosemary Frasso, Allison E. Curry

Open Access Study protocol

The effects of exercise on the quality of life of patients with breast cancer (the UMBRELLA Fit study): study protocol for a randomized controlled trial

Roxanne Gal, Evelyn M. Monninkhof, Rolf H. H. Groenwold, Carla H. van Gils, Desiree H. J. G. van den Bongard, Petra H. M. Peeters, Helena M. Verkooijen, Anne M. May

Open Access Study protocol

Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project)

Ana Isabel González-González, Carola Orrego, Lilisbeth Perestelo-Perez, Carlos Jesús Bermejo-Caja, Nuria Mora, Débora Koatz, Marta Ballester, Tasmania del Pino, Jeannet Pérez-Ramos, Ana Toledo-Chavarri, Noemí Robles, Francisco Javier Pérez-Rivas, Ana Belén Ramírez-Puerta, Yolanda Canellas-Criado, Yolanda del Rey-Granado, Marcos José Muñoz-Balsa, Beatriz Becerril-Rojas, David Rodríguez-Morales, Luis Sánchez-Perruca, José Ramón Vázquez, Armando Aguirre

Open Access Study protocol

SCORE: Shared care of Colorectal cancer survivors: protocol for a randomised controlled trial

Michael Jefford, Jon Emery, Eva Grunfeld, Andrew Martin, Paula Rodger, Alexandra M. Murray, Richard De Abreu Lourenco, Alexander Heriot, Jo Phipps-Nelson, Lisa Guccione, Dorothy King, Karolina Lisy, Niall Tebbutt, Adele Burgess, Ian Faragher, Rodney Woods, Penelope Schofield

Open Access Study protocol

Targeting low- or high-normal Carbon dioxide, Oxygen, and Mean arterial pressure After Cardiac Arrest and REsuscitation: study protocol for a randomized pilot trial

Pekka Jakkula, Matti Reinikainen, Johanna Hästbacka, Ville Pettilä, Pekka Loisa, Sari Karlsson, Raili Laru-Sompa, Stepani Bendel, Tuomas Oksanen, Thomas Birkelund, Marjaana Tiainen, Jussi Toppila, Antti Hakkarainen, Markus B. Skrifvars

Open Access Research

Randomized controlled trial and economic evaluation of nurse-led group support for young mothers during pregnancy and the first year postpartum versus usual care

Jacqueline Barnes, Jane Stuart, Elizabeth Allen, Stavros Petrou, Joanna Sturgess, Jane Barlow, Geraldine Macdonald, Helen Spiby, Dipti Aistrop, Edward Melhuish, Sung Wook Kim, Diana Elbourne

Open Access Study protocol

SlowMo, a digital therapy targeting reasoning in paranoia, versus treatment as usual in the treatment of people who fear harm from others: study protocol for a randomised controlled trial

Philippa A. Garety, Thomas Ward, Daniel Freeman, David Fowler, Richard Emsley, Graham Dunn, Elizabeth Kuipers, Paul Bebbington, Helen Waller, Kathryn Greenwood, Mar Rus-Calafell, Alison McGourty, Amy Hardy

Open Access Study protocol

Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial

Yang-Yang Qian, Hui Chen, Xin-Ying Tang, Xi Jiang, Wei Qian, Wen-Bin Zou, Lei Xin, Bo Li, Yan-Fen Qi, Liang-Hao Hu, Duo-Wu Zou, Zhen-Dong Jin, Dong Wang, Yi-Qi Du, Luo-Wei Wang, Feng Liu, Zhao-Shen Li, Zhuan Liao

Open Access Study protocol

VASO (Vitamin D and Arthroplasty Surgery Outcomes) study - supplementation of vitamin D deficiency to improve outcomes after total hip or knee replacement: study protocol for a randomised controlled feasibility trial

Rory J. M. Morrison, Deborah Bunn, William K. Gray, Paul N. Baker, Craig White, Amar Rangan, Kenneth S. Rankin, Mike R. Reed

Open Access Review

Outcomes in randomised controlled trials in prevention and management of carious lesions: a systematic review

Colin Levey, Nicola Innes, Falk Schwendicke, Thomas Lamont, Gerd Göstemeyer

Open Access Research

Minimal sufficient balance randomization for sequential randomized controlled trial designs: results from the ESCAPE trial

Tolulope T. Sajobi, Gurbakhshash Singh, Mark W. Lowerison, Jordan Engbers, Bijoy K. Menon, Andrew M. Demchuk, Mayank Goyal, Michael D. Hill

Open Access Study protocol

Effect of ketamine combined with magnesium sulfate in neuropathic pain patients (KETAPAIN): study protocol for a randomized controlled trial

Noémie Delage, Véronique Morel, Pascale Picard, Fabienne Marcaillou, Bruno Pereira, Gisèle Pickering

Open Access Study protocol

Effects of a liquefied petroleum gas stove intervention on pollutant exposure and adult cardiopulmonary outcomes (CHAP): study protocol for a randomized controlled trial

Magdalena Fandiño-Del-Rio, Dina Goodman, Josiah L. Kephart, Catherine H. Miele, Kendra N. Williams, Mitra Moazzami, Elizabeth C. Fung, Kirsten Koehler, Victor G. Davila-Roman, Kathryn A. Lee, Saachi Nangia, Steven A. Harvey, Kyle Steenland, Gustavo F. Gonzales, William Checkley

Open Access Study protocol

Autologous-cell-derived, tissue-engineered cartilage for repairing articular cartilage lesions in the knee: study protocol for a randomized controlled trial

Ning Ma, Hongxia Wang, Xian Xu, Yiqun Wan, Yufeng Liu, Mingjie Wang, Wen Yu, Yongjing Dai, Jiang Peng, Quanyi Guo, Changlong Yu, Shibi Lu

Open Access Study protocol

Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial

Hinuga Sandahl, Poul Jennum, Lone Baandrup, Ida Sophie Poschmann, Jessica Carlsson

Open Access Study protocol

Impact of radiographer immediate reporting of chest X-rays from general practice on the lung cancer pathway (radioX): study protocol for a randomised control trial

Nick Woznitza, Anand Devaraj, Samuel M. Janes, Stephen W. Duffy, Angshu Bhowmik, Susan Rowe, Keith Piper, Sue Maughn, David R. Baldwin

Open Access Study protocol

Effects of high-frequency transcranial magnetic stimulation on functional performance in individuals with incomplete spinal cord injury: study protocol for a randomized controlled trial

Amanda Vitória Lacerda de Araújo, Valéria Ribeiro Nogueira Barbosa, Gilma Serra Galdino, Felipe Fregni, Thais Massetti, Sara Lynn Fontes, Danilo de Oliveira Silva, Talita Dias da Silva, Carlos Bandeira de Mello Monteiro, James Tonks, Fernando Henrique Magalhães

Open Access Study protocol

Lactoferrin and lysozyme to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for a randomized controlled trial

William D. Cheng, Karl J. Wold, Nicole S. Benzoni, Chrissie Thakwalakwa, Kenneth M. Maleta, Mark J. Manary, Indi Trehan

Open Access Study protocol

A randomised, double-blind, placebo-controlled trial of minocycline and/or omega-3 fatty acids added to treatment as usual for at-risk mental states (NAYAB): study protocol

Inti Qurashi, Imran B. Chaudhry, Ameer B. Khoso, Sana Farooque, Steve Lane, Mohammad Omair Husain, Simon Chu, Jane Sarginson, Munir Hamarani, Haider A. Naqvi, Bushra Razzaque, Fareed A. Minhas, Alison R. Yung, J. F. W. Deakin, Nusrat Husain

Open Access Study protocol

Efficacy of Banha-sasim-tang on functional dyspepsia classified as excess pattern: study protocol for a randomized controlled trial

Yun Hee Kim, Jun Young Kim, So Young Jung, O-Jin Kwon, Jun-Hwan Lee, Chang-Gue Son

Open Access Study protocol

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial

Jordan Miller, David Barber, Catherine Donnelly, Simon French, Michael Green, Jonathan Hill, Joy MacDermid, Jacquelyn Marsh, Kathleen Norman, Julie Richardson, Monica Taljaard, Timothy Wideman, Lynn Cooper, Colleen McPhee

Open Access Study protocol

A multicomponent intervention for the management of chronic pain in older adults: study protocol for a randomized controlled trial

Sheung-Tak Cheng, Ka Long Chan, Rosanna W. L. Lau, Monique H. T. Mok, Phoon Ping Chen, Yu Fat Chow, Joanne W. Y. Chung, Alexander C. B. Law, Jenny S. W. Lee, Edward M. F. Leung, Cindy W. C. Tam

Open Access Study protocol

Platelet inhibition during ticagrelor monotherapy versus ticagrelor plus aspirin in patients with coronary artery disease (TEMPLATE study): study protocol for a randomised controlled trial

Sarah Baos, Wendy Underwood, Lucy Culliford, Barnaby C. Reeves, Chris A. Rogers, Ruth Bowles, Tom Johnson, Andreas Baumbach, Andrew Mumford

Open Access Study protocol

Adjunctive use of physostigmine salicylate (Anticholium®) in perioperative sepsis and septic shock: study protocol for a randomized, double-blind, placebo-controlled, monocentric trial (Anticholium® per Se)

Johannes B. Zimmermann, Nadine Pinder, Thomas Bruckner, Monika Lehmann, Johann Motsch, Thorsten Brenner, Torsten Hoppe-Tichy, Stefanie Swoboda, Markus A. Weigand, Stefan Hofer

Open Access Commentary

Advancing ‘real-world’ trials that take account of social context and human volition

Anders Blædel Gottlieb Hansen, Allan Jones

Open Access Research

Framing the conversation: use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains

Paula Darby Lipman, Kirsty Loudon, Leanora Dluzak, Rachael Moloney, Donna Messner, Catherine M. Stoney

Open Access Methodology

Impact of a deferred recruitment model in a randomised controlled trial in primary care (CREAM study)

Victoria Shepherd, Emma Thomas-Jones, Matthew J. Ridd, Kerenza Hood, Katy Addison, Nick A. Francis

Open Access Study protocol

Early screening for Chlamydia trachomatis in young women for primary prevention of pelvic inflammatory disease (i-Predict): study protocol for a randomised controlled trial

Jeanne Tamarelle, Anne C. M. Thiébaut, Bénédicte Sabin, Cécile Bébéar, Philippe Judlin, Arnaud Fauconnier, Delphine Rahib, Layidé Méaude-Roufai, Jacques Ravel, Servaas A. Morré, Bertille de Barbeyrac, Elisabeth Delarocque-Astagneau, Elisabeth Delarocque-Astagneau, Anne Thiébaut, Jeanne Tamarelle, Bertille de Barbeyrac, Cécile Bébéar, Servaas Morré, Jacques Ravel, Emmanuelle Mathiot-Vicaigne, Christian Régnier, Philippe Aoussou, Raphaelle Badie-Perez, Karine Rebouillat, Christophe Tzourio, Anne-Cécile Rahis, Arnaud Fauconnier, Antoine Bourret, Jean-Luc Brun, André Bongain, Philippe Aegerter, Layidé Méaude-Roufai, Delphine Rahib, Nathalie Lydié

Open Access Study protocol

INfluence of Successful Periodontal Intervention in REnal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial

Praveen Sharma, Paul Cockwell, Thomas Dietrich, Charles Ferro, Natalie Ives, Iain L. C. Chapple

Open Access Study protocol

Comparison of the efficacy and safety of FP-1201-lyo (intravenously administered recombinant human interferon beta-1a) and placebo in the treatment of patients with moderate or severe acute respiratory distress syndrome: study protocol for a randomized controlled trial

Geoff Bellingan, David Brealey, Jordi Mancebo, Alain Mercat, Nicolò Patroniti, Ville Pettilä, Michael Quintel, Jean-Louis Vincent, Mikael Maksimow, Markku Jalkanen, Ilse Piippo, V. Marco Ranieri

Open Access Study protocol

Acupuncture for postprandial distress syndrome (APDS): study protocol for a randomized controlled trial

Jing-Wen Yang, Li-Wen Zhang, Guang-Xia Shi, Yi Du, Jun Wang, Jing-Jie Zhao, Yan Cao, Jian-Feng Tu, Shuai Zhang, Cheng Tan, San-San Chen, Cun-Zhi Liu

Open Access Study protocol

Trial of Acute Femoral Fracture Fixation (TrAFFix): study protocol for a randomised controlled feasibility trial

Xavier L. Griffin, Matthew L. Costa, Juul Achten, Melina Dritsaki, Janis Baird, Nicholas Parsons

Open Access Study protocol

Can integrating the Memory Support Intervention into cognitive therapy improve depression outcome? Study protocol for a randomized controlled trial

Allison G. Harvey, Lu Dong, Jason Y. Lee, Nicole B. Gumport, Steven D. Hollon, Sophia Rabe-Hesketh, Kerrie Hein, Kirsten Haman, Mary E. McNamara, Claire Weaver, Armando Martinez, Haruka Notsu, Garret Zieve, Courtney C. Armstrong

Open Access Research

The marketing plan and outcome indicators for recruiting and retaining parents in the HomeStyles randomized controlled trial

Carol Byrd-Bredbenner, Colleen Delaney, Jennifer Martin-Biggers, Mallory Koenings, Virginia Quick

Open Access Study protocol

The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs

Maïté Garrouste-Orgeas, Cécile Flahault, Léonor Fasse, Stéphane Ruckly, Nora Amdjar-Badidi, Laurent Argaud, Julio Badie, Amélie Bazire, Naike Bige, Eric Boulet, Lila Bouadma, Cédric Bretonnière, Bernard Floccard, Alain Gaffinel, Xavier de Forceville, Hubert Grand, Rebecca Halidfar, Olfa Hamzaoui, Mercé Jourdain, Paul-Henri Jost, Eric Kipnis, Audrey Large, Alexandre Lautrette, Olivier Lesieur, Virginie Maxime, Emmanuelle Mercier, Jean Paul Mira, Yannick Monseau, Erika Parmentier-Decrucq, Jean-Philippe Rigaud, Antoine Rouget, François Santoli, Georges Simon, Fabienne Tamion, Nathalie Thieulot-Rolin, Marina Thirion, Sandrine Valade, Isabelle Vinatier, Christel Vioulac, Sebastien Bailly, Jean-François Timsit

Open Access Study protocol

Preventing enduring behavioural problems in young children through early psychological intervention (Healthy Start, Happy Start): study protocol for a randomized controlled trial

Paul G. Ramchandani, Christine O’Farrelly, Daphne Babalis, Marian J. Bakermans-Kranenburg, Sarah Byford, Ellen S. R. Grimas, Jane E. Iles, Marinus H. van IJzendoorn, Julia McGinley, Charlotte M. Phillips, Alan Stein, Jane Warwick, Hillary C. Watt, Stephen Scott

Open Access Study protocol

Group physiotherapy compared to individual physiotherapy to treat urinary incontinence in aging women: study protocol for a randomized controlled trial

Chantale Dumoulin, Mélanie Morin, Marie-Hélène Mayrand, Michel Tousignant, Michal Abrahamowicz

Open Access Study protocol

Allogeneic mesenchymal stem cell as induction therapy to prevent both delayed graft function and acute rejection in deceased donor renal transplantation: study protocol for a randomized controlled trial

Qipeng Sun, Liangqing Hong, Zhengyu Huang, Ning Na, Xuefeng Hua, Yanwen Peng, Ming Zhao, Ronghua Cao, Qiquan Sun

Open Access Research

Improving readiness for recruitment through simulated trial activation: the Adjuvant Steroids in Adults with Pandemic influenza (ASAP) trial

Wei Shen Lim, Garry Meakin, Clare Brittain, Thomas Bewick, Lelia Duley

Open Access Study protocol

Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN): study protocol for a randomised controlled trial

Sophie E. Rowbotham, Jenna L. Pinchbeck, Georgina Anderson, Bernie Bourke, Michael Bourke, T. Christian Gasser, Rene Jaeggi, Jason S. Jenkins, Corey S. Moran, Susan K. Morton, Christopher M. Reid, Ramesh Velu, Lisan Yip, Joseph V. Moxon, Jonathan Golledge

Open Access Research

Quality of intervention delivery in a cluster randomised controlled trial: a qualitative observational study with lessons for fidelity

Karen James, Alan Quirk, Sue Patterson, Geoff Brennan, Duncan Stewart

Open Access Study protocol

Concomitant, sequential, and 7-day triple therapy in first-line treatment of Helicobacter pylori infection in Korea: study protocol for a randomized controlled trial

Hyuk Lee, Beom Jin Kim, Sang Gyun Kim, Jin Il Kim, Il Ju Choi, Yong Chan Lee, Jae G. Kim, Jae J. Kim

Open Access Study protocol

The Kusamala Program for primary caregivers of children 6–59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial

Allison I. Daniel, Meta van den Heuvel, Wieger P. Voskuijl, Melissa Gladstone, Mike Bwanali, Isabel Potani, Celine Bourdon, Jenala Njirammadzi, Robert H. J. Bandsma

Open Access Study protocol

Trial to Incentivise Adherence for Diabetes (TRIAD): study protocol for a randomised controlled trial

Marcel Bilger, Mitesh Shah, Ngiap Chuan Tan, Kaye Louise Howard, Hui Yan Xu, Ecosse Luc Lamoureux, Eric Andrew Finkelstein

Open Access Study protocol

The PREVENT study to evaluate the effectiveness and acceptability of a community-based intervention to prevent childhood tuberculosis in Lesotho: study protocol for a cluster randomized controlled trial

Yael Hirsch-Moverman, Andrea A. Howard, Koen Frederix, Limakatso Lebelo, Anneke Hesseling, Sharon Nachman, Joanne E. Mantell, Tsepang Lekhela, Llang Bridget Maama, Wafaa M. El-Sadr

Open Access Study protocol

Effect of Daikenchuto (TJ-100) on gastrointestinal symptoms following laparoscopic colectomy in patients with colon cancer: study protocol for a randomized controlled trial

Nobuaki Hoshino, Kenji Kawada, Koya Hida, Toshiaki Wada, Ryo Takahashi, Mami Yoshitomi, Yoshiharu Sakai

Open Access Study protocol

Comparison of the effect of high versus low mean arterial pressure levels on clinical outcomes and complications in elderly patients during non-cardiothoracic surgery under general anesthesia: study protocol for a randomized controlled trial

Anmin Hu, Yan Qiu, Peng Zhang, Bailong Hu, Yali Yang, Shutao Li, Rui Zhao, Zhongjun Zhang, Yaoxian Zhang, Zihao Zheng, Chen Qiu, Furong Li, Xiaolei Gong

Open Access Study protocol

Text messages to increase attendance to follow-up cervical cancer screening appointments among HPV-positive Tanzanian women (Connected2Care): study protocol for a randomised controlled trial

Ditte S. Linde, Marianne S. Andersen, Julius D. Mwaiselage, Rachel Manongi, Susanne K. Kjaer, Vibeke Rasch

Open Access Review

A systematic literature review of evidence-based clinical practice for rare diseases: what are the perceived and real barriers for improving the evidence and how can they be overcome?

Ana Rath, Valérie Salamon, Sandra Peixoto, Virginie Hivert, Martine Laville, Berenice Segrestin, Edmund A. M. Neugebauer, Michaela Eikermann, Vittorio Bertele, Silvio Garattini, Jørn Wetterslev, Rita Banzi, Janus C. Jakobsen, Snezana Djurisic, Christine Kubiak, Jacques Demotes-Mainard, Christian Gluud

Open Access Research

The Treatment In Morning versus Evening (TIME) study: analysis of recruitment, follow-up and retention rates post-recruitment

David A. Rorie, Robert W. V. Flynn, Isla S. Mackenzie, Thomas M. MacDonald, Amy Rogers

Open Access Study protocol

The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients: study protocol for a randomised controlled trial

Jonathan Kingslake, Rebecca Dias, Gerard R. Dawson, Judit Simon, Guy M. Goodwin, Catherine J. Harmer, Richard Morriss, Susan Brown, Boliang Guo, Colin T. Dourish, Henricus G. Ruhé, Anne G. Lever, Dick J. Veltman, Anneke van Schaik, Jürgen Deckert, Andreas Reif, Michael Stäblein, Andreas Menke, Philip Gorwood, Géraldine Voegeli, Victor Pérez, Michael Browning

Open Access Methodology

Network methods to support user involvement in qualitative data analyses: an introduction to Participatory Theme Elicitation

Paul Best, Jennifer Badham, Rekesh Corepal, Roisin F. O’Neill, Mark A. Tully, Frank Kee, Ruth F. Hunter

Open Access Study protocol

Standardised Outcomes in Nephrology—Polycystic Kidney Disease (SONG-PKD): study protocol for establishing a core outcome set in polycystic kidney disease

Yeoungjee Cho, Benedicte Sautenet, Gopala Rangan, Jonathan C. Craig, Albert C. M. Ong, Arlene Chapman, Curie Ahn, Dongping Chen, Helen Coolican, Juliana Tze-Wah Kao, Ron Gansevoort, Ronald Perrone, Tess Harris, Vicente Torres, York Pei, Peter G. Kerr, Jessica Ryan, Talia Gutman, Martin Howell, Angela Ju, Karine E. Manera, Armando Teixeira-Pinto, Lorraine A. Hamiwka, Allison Tong

Open Access Study protocol

Guided self-determination-young versus standard care in the treatment of young females with type 1 diabetes: study protocol for a multicentre randomized controlled trial

Josephine Haas, Martina Persson, Anna Lena Brorsson, Eva Hagström Toft, Anna Lindholm Olinder

Open Access Study protocol

An optimized background regimen design to evaluate the contribution of levofloxacin to multidrug-resistant tuberculosis treatment regimens: study protocol for a randomized controlled trial

Tara C. Bouton, Patrick P. J. Phillips, Carole D. Mitnick, Charles A. Peloquin, Kathleen Eisenach, Ramonde F. Patientia, Leonid Lecca, Eduardo Gotuzzo, Neel R. Gandhi, Donna Butler, Andreas H. Diacon, Bruno Martel, Juan Santillan, Kathleen Robergeau Hunt, Dante Vargas, Florian von Groote-Bidlingmaier, Carlos Seas, Nancy Dianis, Antonio Moreno-Martinez, C. Robert Horsburgh Jr.

Open Access Study protocol

Herbst appliance with skeletal anchorage versus dental anchorage in adolescents with Class II malocclusion: study protocol for a randomised controlled trial

Klaus Barretto dos Santos Lopes Batista, Tatiana Lima, Nathália Palomares, Felipe de Assis Carvalho, Cátia Quintão, José Augusto Mendes Miguel, Yin-Ling Lin, Ting-Li Su, Kevin O’Brien

Open Access Study protocol

Cost evaluation, quality of life and pelvic organ function of three approaches to hysterectomy for benign uterine conditions: study protocol for a randomized controlled trial

Chanil Ekanayake, Arunasalam Pathmeswaran, Sanjeewa Kularatna, Rasika Herath, Prasantha Wijesinghe

Open Access Study protocol

The influence of surface EMG-triggered multichannel electrical stimulation on sensomotoric recovery in patients with lumbar disc herniation: study protocol for a randomized controlled trial (RECO)

Sara Lener, Christoph Wipplinger, Sebastian Hartmann, Wolfgang N. Löscher, Sabrina Neururer, Matthias Wildauer, Claudius Thomé, Anja Tschugg

Open Access Study protocol

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial

Amanda L. Graham, Michael V. Burke, Megan A. Jacobs, Sarah Cha, Ivana T. Croghan, Darrell R. Schroeder, James P. Moriarty, Bijan J. Borah, Donna F. Rasmussen, M. Jody Brookover, Dale B. Suesse, David E. Midthun, J. Taylor Hays

Open Access Study protocol

The effect of an intensive smoking cessation intervention on disease activity in patients with rheumatoid arthritis: study protocol for a randomised controlled trial

Ida Kristiane Roelsgaard, Thordis Thomsen, Mikkel Østergaard, Robin Christensen, Merete Lund Hetland, Søren Jacobsen, Lena Andersen, Hanne Tønnesen, Silvia Rollefstad, Anne Grete Semb, Bente Appel Esbensen

Open Access Study protocol

Prophylactic penehyclidine inhalation for prevention of postoperative pulmonary complications in high-risk patients: study protocol of a randomized controlled trial

Ting Yan, Xin-Quan Liang, Tong Wang, Wei-Ou Li, Hui-Juan Li, Sai-Nan Zhu, Dong-Xin Wang

Open Access Study protocol

Core Health Outcomes In Childhood Epilepsy (CHOICE): protocol for the selection of a core outcome set

Christopher Morris, Colin Dunkley, Frances M. Gibbon, Janet Currier, Deborah Roberts, Morwenna Rogers, Holly Crudgington, Lucy Bray, Bernie Carter, Dyfrig Hughes, Catrin Tudur Smith, Paula R. Williamson, Paul Gringras, Deb K. Pal

Open Access Update

Statistical analysis plan for the EuroHYP-1 trial: European multicentre, randomised, phase III clinical trial of the therapeutic hypothermia plus best medical treatment versus best medical treatment alone for acute ischaemic stroke

Per Winkel, Philip M. Bath, Christian Gluud, Jane Lindschou, H. Bart van der Worp, Malcolm R. Macleod, Istvan Szabo, Isabelle Durand-Zaleski, Stefan Schwab

Open Access Study protocol

Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial

Sikandar H. Khan, Sophia Wang, Amanda Harrawood, Stephanie Martinez, Annie Heiderscheit, Linda Chlan, Anthony J. Perkins, Wanzhu Tu, Malaz Boustani, Babar Khan

Open Access Study protocol

Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial

Katherine A. Pohlman, Linda Carroll, Ross T. Tsuyuki, Lisa Hartling, Sunita Vohra

Open Access Study protocol

COSUMO: study protocol for the development of a core outcome set for efficacy and effectiveness trials in posterior segment-involving uveitis

Mohammad O. Tallouzi, Jonathan M. Mathers, David J. Moore, Philip I. Murray, Nicholas Bucknall, Jane M. Blazeby, Melanie Calvert, Alastair K. Denniston

Open Access Study protocol

Does motivation matter in upper-limb rehabilitation after stroke? ArmeoSenso-Reward: study protocol for a randomized controlled trial

Mario Widmer, Jeremia P. Held, Frieder Wittmann, Olivier Lambercy, Kai Lutz, Andreas R. Luft

Open Access Study protocol

Timing of oral anticoagulant therapy in acute ischemic stroke with atrial fibrillation: study protocol for a registry-based randomised controlled trial

Signild Åsberg, Ziad Hijazi, Bo Norrving, Andreas Terént, Patrik Öhagen, Jonas Oldgren

Open Access Study protocol

Low tidal volume mechanical ventilation against no ventilation during cardiopulmonary bypass heart surgery (MECANO): study protocol for a randomized controlled trial

Lee S. Nguyen, Messaouda Merzoug, Philippe Estagnasie, Alain Brusset, Jean-Dominique Law Koune, Stephane Aubert, Thierry Waldmann, Jean-Michel Grinda, Hadrien Gibert, Pierre Squara

Open Access Study protocol

PERFECTED enhanced recovery (PERFECT-ER) care versus standard acute care for patients admitted to acute settings with hip fracture identified as experiencing confusion: study protocol for a feasibility cluster randomized controlled trial

Simon P. Hammond, Jane L. Cross, Lee Shepstone, Tamara Backhouse, Catherine Henderson, Fiona Poland, Erika Sims, Alasdair MacLullich, Bridget Penhale, Robert Howard, Nigel Lambert, Anna Varley, Toby O. Smith, Opinder Sahota, Simon Donell, Martyn Patel, Clive Ballard, John Young, Martin Knapp, Stephen Jackson, Justin Waring, Nick Leavey, Gregory Howard, Chris Fox

Open Access Study protocol

Nutrition education for cardiovascular disease prevention in individuals with spinal cord injuries: study protocol for a randomized controlled trial

Jesse A. Lieberman, Jacquelyn W. McClelland, David C. Goff Jr., Elizabeth Racine, Michael F. Dulin, William A. Bauman, Janet Niemeier, Mark A. Hirsch, H. James Norton, Charity G. Moore

Open Access Study protocol

Coping with Unusual ExperienceS for 12–18 year olds (CUES+): a transdiagnostic randomised controlled trial of the effectiveness of cognitive therapy in reducing distress associated with unusual experiences in adolescent mental health services: study protocol for a randomised controlled trial

Suzanne Jolley, Sophie Browning, Richard Corrigall, Kristin R. Laurens, Colette Hirsch, Karen Bracegirdle, Kimberley Gin, Francesca Muccio, Catherine Stewart, Partha Banerjea, Elizabeth Kuipers, Philippa Garety, Majella Byrne, Juliana Onwumere, Evanthia Achilla, Paul McCrone, Richard Emsley

Open Access Study protocol

A novel Family Dignity Intervention (FDI) for enhancing and informing holistic palliative care in Asia: study protocol for a randomized controlled trial

Andy Hau Yan Ho, Josip Car, Moon-Ho Ringo Ho, Geraldine Tan-Ho, Ping Ying Choo, Paul Victor Patinadan, Poh Heng Chong, Wah Ying Ong, Gilbert Fan, Yee Pin Tan, Robert A. Neimeyer, Harvey M. Chochinov

Open Access Study protocol

Testing the 4Rs and 2Ss Multiple Family Group intervention: study protocol for a randomized controlled trial

Mary Acri, Emily Hamovitch, Maria Mini, Elene Garay, Claire Connolly, Mary McKay

Open Access Study protocol

Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial

Corinna Nerz, Lars Schwickert, Clemens Becker, Stefan Studier-Fischer, Janina Anna Müßig, Peter Augat

Open Access Research

A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials

Elizabeth J. Conroy, Barbara Arch, Nicola L. Harman, J. Athene Lane, Steff C. Lewis, John Norrie, Matthew R. Sydes, Carrol Gamble

Open Access Study protocol

Does intensive management improve remission rates in patients with intermediate rheumatoid arthritis? (the TITRATE trial): study protocol for a randomised controlled trial

Naomi H. Martin, Fowzia Ibrahim, Brian Tom, James Galloway, Allan Wailoo, Jonathan Tosh, Heidi Lempp, Louise Prothero, Sofia Georgopoulou, Jackie Sturt, David L. Scott, Heidi Lempp, Jackie Sturt, Sofia Georgopoulou, Louise Prothero, Naomi Martin, Richard Jenner, Isabel Neatrour, Rhiannon Baggott, Fowzia Ibrahim, Brian Tom, Allan Wailoo, Jonathan Tosh, James Galloway, Gabrielle Kingsley, David Scott, Brian Tom, Fowzia Ibrahim, Yujie Zhong, Aneela Mian, James Galloway, David L. Scott

Open Access Study protocol

Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial

Ahmed A. Abouarab, Jeremy R. Leonard, Lucas B. Ohmes, Christopher Lau, Lisa Q. Rong, Natalia S. Ivascu, Kane O. Pryor, Monica Munjal, Filippo Crea, Massimo Massetti, Tommaso Sanna, Leonard N. Girardi, Mario Gaudino

Open Access Study protocol

Adolescent Coordinated Transition (ACT) to improve health outcomes among young people living with HIV in Nigeria: study protocol for a randomized controlled trial

Nadia A. Sam-Agudu, Jennifer R. Pharr, Tamara Bruno, Chad L. Cross, Llewellyn J. Cornelius, Prosper Okonkwo, Bolanle Oyeledun, Hadiza Khamofu, Ayodotun Olutola, Salome Erekaha, William Nii Ayitey Menson, Echezona E. Ezeanolue

Open Access Study protocol

Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial

Kjersti Storheim, Ansgar Espeland, Lars Grøvle, Jan Sture Skouen, Jörg Aßmus, Audny Anke, Anne Froholdt, Linda M. Pedersen, Anne Julsrud Haugen, Terese Fors, Elina Schistad, Olav Lutro, Gunn Hege Marchand, Thomas Kadar, Nils Vetti, Sigrun Randen, Øystein Petter Nygaard, Jens Ivar Brox, Margreth Grotle, John-Anker Zwart

Open Access Review

SCORE-IT (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes): a systematic review of registered trials

Nicola L. Harman, Rebecca James, John Wilding, Paula R. Williamson, ᅟ Serena, ᅟ Battaglia, Jacques Demotes-Mainard, Valerie Gailus-Durner, Silvio Garattini, Cecilia A. C. Prinsen, Michael Raess, Patricia da Silva-Buttkus, Caroline B. Terwee

Open Access Correction

Correction to Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial

Nicolle M. Krebs, Sophia I. Allen, Susan Veldheer, Diane J. Martinez, Kimberly Horn, Craig Livelsberger, Jennifer Modesto, Robin Kuprewicz, Ashley Wilhelm, Shari Hrabovsky, Abid Kazi, Alyse Fazzi, Jason Liao, Junjia Zhu, Emily Wasserman, Samantha M. Reilly, Lisa Reinhart, Neil Trushin, Robinn E. Moyer, Rebecca Bascom, Jonathan Foulds, John P. Richie Jr, Joshua E. Muscat

Open Access Correction

Correction to: Concomitant, sequential, and 7-day triple therapy in first-line treatment of Helicobacter pylori infection in Korea: study protocol for a randomized controlled trial

Hyuk Lee, Beom Jin Kim, Sang Gyun Kim, Jin Il Kim, Il Ju Choi, Yong Chan Lee, Jae G. Kim, Jae J. Kim

Open Access Study protocol

Intraoperative oxygen concentration and neurocognition after cardiac surgery: study protocol for a randomized controlled trial

Shahzad Shaefi, Edward R. Marcantonio, Ariel Mueller, Valerie Banner-Goodspeed, Simon C. Robson, Kyle Spear, Leo E. Otterbein, Brian P. O’Gara, Daniel S. Talmor, Balachundhar Subramaniam

Open Access Study protocol

Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial

Francisco A. H. Fonseca, Maria Cristina Izar, Ieda M. L. Maugeri, Otavio Berwanger, Lucas P. Damiani, Ibraim M. Pinto, Gilberto Szarf, Carolina N. França, Henrique T. Bianco, Flavio T. Moreira, Adriano Caixeta, Claudia M. R. Alves, Aline Soriano Lopes, Aline Klassen, Marina F. M. Tavares, Henrique A. Fonseca, Antonio C. C. Carvalho

Open Access Research

A core outcomes set for clinical trials of interventions for young adults with type 1 diabetes: an international, multi-perspective Delphi consensus study

Molly Byrne, Anthony O’Connell, Aoife M. Egan, Sean F. Dinneen, Lisa Hynes, Mary Clare O’Hara, Richard I. G. Holt, Ingrid Willaing, Michael Vallis, Christel Hendrieckx, Imelda Coyne

Open Access Study protocol

Establishing core outcome sets for phenylketonuria (PKU) and medium-chain Acyl-CoA dehydrogenase (MCAD) deficiency in children: study protocol for systematic reviews and Delphi surveys

Beth K. Potter, Brian Hutton, Tammy J. Clifford, Nicole Pallone, Maureen Smith, Sylvia Stockler, Pranesh Chakraborty, Pauline Barbeau, Chantelle M. Garritty, Michael Pugliese, Alvi Rahman, Becky Skidmore, Laure Tessier, Kylie Tingley, Doug Coyle, Cheryl R. Greenberg, Lawrence Korngut, Alex MacKenzie, John J. Mitchell, Stuart Nicholls, Martin Offringa, Andreas Schulze, Monica Taljaard

Open Access Study protocol

Cost-benefit and extended cost-effectiveness analysis of a comprehensive adolescent pregnancy prevention program in Zambia: study protocol for a cluster randomized controlled trial

Amani Thomas Mori, Linda Kampata, Patrick Musonda, Kjell Arne Johansson, Bjarne Robberstad, Ingvild Sandøy

Open Access Study protocol

The effect of Danshen extract on lipoprotein-associated phospholipase A2 levels in patients with stable angina pectoris: study protocol for a randomized controlled trial - the DOLPHIN study

A-Di Chen, Chun-Ling Wang, Yang Qin, Liang Tian, Li-Bin Chen, Xiao-Ming Yuan, Lin-Xiu Ma, Yu-Feng Wang, Ji-Rong Sun, Hao-Sen Wang, Neng Dai

Open Access Update

Statistical analysis plan for the ‘Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage’ (TICH-2) trial

Katie Flaherty, Philip M. Bath, Robert Dineen, Zhe Law, Polly Scutt, Stuart Pocock, Nikola Sprigg

Open Access Study protocol

Additive effect of tDCS combined with Peripheral Electrical Stimulation to an exercise program in pain control in knee osteoarthritis: study protocol for a randomized controlled trial

Cleber Luz-Santos, Janine Ribeiro Camatti, Alaí Barbosa Paixão, Katia Nunes Sá, Pedro Montoya, Michael Lee, Abrahão Fontes Baptista

Open Access Study protocol

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry

Alvin H. Li, Amit X. Garg, Versha Prakash, Jeremy M. Grimshaw, Monica Taljaard, Joanna Mitchell, Danny Matti, Stefanie Linklater, Kyla L. Naylor, Stephanie Dixon, Cathy Faulds, Rachel Bevan, Leah Getchell, Greg Knoll, S. Joseph Kim, Jessica Sontrop, Lise M. Bjerre, Allison Tong, Justin Presseau

Open Access Study protocol

The ‘Outcome Reporting in Brief Intervention Trials: Alcohol’ (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention

G. W. Shorter, N. Heather, Jeremy W. Bray, E. L. Giles, A. Holloway, C. Barbosa, A. H. Berman, A. J. O’Donnell, M. Clarke, K. J. Stockdale, D. Newbury-Birch

Open Access Research

‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact

Anne Daykin, Lucy E. Selman, Helen Cramer, Sharon McCann, Gillian W. Shorter, Matthew R. Sydes, Carrol Gamble, Rhiannon Macefield, J. Athene Lane, Alison Shaw

Open Access Study protocol

United Kingdom Frozen Shoulder Trial (UK FROST), multi-centre, randomised, 12 month, parallel group, superiority study to compare the clinical and cost-effectiveness of Early Structured Physiotherapy versus manipulation under anaesthesia versus arthroscopic capsular release for patients referred to secondary care with a primary frozen shoulder: study protocol for a randomised controlled trial

Stephen Brealey, Alison L. Armstrong, Andrew Brooksbank, Andrew Jonathan Carr, Charalambos P. Charalambous, Cushla Cooper, Belen Corbacho, Joseph Dias, Iona Donnelly, Lorna Goodchild, Catherine Hewitt, Ada Keding, Lucksy Kottam, Sarah E. Lamb, Catriona McDaid, Matthew Northgraves, Gerry Richardson, Sara Rodgers, Sarwat Shah, Emma Sharp, Sally Spencer, David Torgerson, Francine Toye, Amar Rangan

Open Access Commentary

Undertaking a randomised controlled trial in the police setting: methodological and practical challenges

Arabella Scantlebury, Catriona McDaid, Alison Booth, Caroline Fairhurst, Adwoa Parker, Rebecca Payne, Helen Reed, William J. Scott, David Torgerson, Catherine Hewitt

Open Access Study protocol

Acupuncture for chronic prostatitis/chronic pelvic pain syndrome: study protocol for a randomized controlled trial

Zongshi Qin, Yan Liu, Kehua Zhou, Jiani Wu, Ran Pang, Ning Li, Chang Xu, Joey S. W. Kwong, Zhishun Liu

Open Access Study protocol

Nitrous oxide (N2O) and subsequent open-label SSRI treatment of adolescents with depression (NOTAD): study protocol for a randomised controlled trial

Richard M. Stewart, Janice W. Y. Wong, Kevin C. Runions, Pradeep Rao, Julia K. Moore, Simon R. Davies, Britta S. von Ungern-Sternberg, David Sommerfield, Florian Daniel Zepf

Open Access Study protocol

Simulated patient encounters to improve adolescent retention in HIV care in Kenya: study protocol of a stepped-wedge randomized controlled trial

Kate S. Wilson, Cyrus Mugo, David Bukusi, Irene Inwani, Anjuli D. Wagner, Helen Moraa, Tamara Owens, Joseph B. Babigumira, Barbra A. Richardson, Grace C. John-Stewart, Jennifer A. Slyker, Dalton C. Wamalwa, Pamela K. Kohler

Open Access Commentary

Challenges in implementing model-based phase I designs in a grant-funded clinical trials unit

Eleni Frangou, Jane Holmes, Sharon Love, Naomi McGregor, Maria Hawkins

Open Access Study protocol

Azithromycin versus placebo for the treatment of HIV-associated chronic lung disease in children and adolescents (BREATHE trial): study protocol for a randomised controlled trial

Carmen Gonzalez-Martinez, Katharina Kranzer, Grace McHugh, Elizabeth L. Corbett, Hilda Mujuru, Mark P. Nicol, Sarah Rowland-Jones, Andrea M. Rehman, Tore J. Gutteberg, Trond Flaegstad, Jon O. Odland, Rashida A. Ferrand, Tsitsi Bandason, Pauline Cavanagh, Ethel Dauya, Edith Majonga, Beauty Makamure, Gugulethu Newton Mapurisa, Slee Mbhele, Brewster Wisdom Moyo, Lucky Gift Ngwira, Jamie Rylance, Victoria Simms, Evgeniya Sovershaeva, Helen Anne Weiss, Louis-Marie Yindom

Open Access Research

Promoting Recruitment using Information Management Efficiently (PRIME): a stepped-wedge, cluster randomised trial of a complex recruitment intervention embedded within the REstart or Stop Antithrombotics Randomised Trial

Amy E. Maxwell, Richard A. Parker, Jonathan Drever, Anthony Rudd, Martin S. Dennis, Christopher J. Weir, Rustam Al-Shahi Salman

Open Access Review

Reporting quality of randomized controlled trials in patients with HIV on antiretroviral therapy: a systematic review

Kaori Nagai, Akiko M. Saito, Toshiki I. Saito, Noriyo Kaneko

Open Access Research

Safety and efficacy of inspiratory muscle training for preventing adverse outcomes in patients at risk of prolonged hospitalisation

Balbino Rivail Ventura Nepomuceno Jr., Mayana de Sá Barreto, Naniane Cidreira Almeida, Caroline Ferreira Guerreiro, Eveline Xavier-Souza, Mansueto Gomes Neto

Open Access Update

The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis

Catriona Graham, Steff Lewis, John Forbes, Gillian Mead, Maree L. Hackett, Graeme J. Hankey, John Gommans, Huy Thang Nguyen, Erik Lundström, Eva Isaksson, Per Näsman, Ann-Sofie Rudberg, Martin Dennis

Open Access Study protocol

Development of a core outcome set for studies involving patients undergoing major lower limb amputation for peripheral arterial disease: study protocol for a systematic review and identification of a core outcome set using a Delphi survey

Graeme K. Ambler, David C. Bosanquet, Lucy Brookes-Howell, Emma Thomas-Jones, Cherry-Ann Waldron, Adrian G. K. Edwards, Christopher P. Twine

Open Access Study protocol

Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT): study protocol for a randomised controlled pilot study

David C. Bosanquet, Graeme K. Ambler, Cherry-Ann Waldron, Emma Thomas-Jones, Lucy Brookes-Howell, Mark Kelson, Tim Pickles, Debbie Harris, Deborah Fitzsimmons, Neeraj Saxena, Christopher P. Twine

Open Access Study protocol

Exercise intervention for unilateral amputees with low back pain: study protocol for a randomised, controlled trial

Joseph G. Wasser, Daniel C. Herman, MaryBeth Horodyski, Jason L. Zaremski, Brady Tripp, Phillip Page, Kevin R. Vincent, Heather K. Vincent

Open Access Study protocol

Chinese herbal medicine TangBi Formula treatment of patients with type 2 diabetic distal symmetric polyneuropathy disease: study protocol for a randomized controlled trial

De Jin, Wen-jing Huang, Xiang Meng, Fan Yang, Yu-jiao Zheng, Qi Bao, Mei-zhen Zhang, Ya-nan Yang, Qing Ni, Feng-mei Lian, Xiao-lin Tong

Open Access Study protocol

FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial

Jang-Young Kim, Jung-Woo Son, Sungha Park, Tea-Hyun Yoo, Yong-Jin Kim, Dong-Ryeol Ryu, Ho Jun Chin

Open Access Study protocol

The NAPRESSIM trial: the use of low-dose, prophylactic naloxone infusion to prevent respiratory depression with intrathecally administered morphine in elective hepatobiliary surgery: a study protocol and statistical analysis plan for a randomised controlled trial

David Cosgrave, Marie Galligan, Era Soukhin, Victoria McMullan, Siobhan McGuinness, Anand Puttappa, Niamh Conlon, John Boylan, Rabia Hussain, Peter Doran, Alistair Nichol