Ausgabe 1/2016
Inhalt (608 Artikel)
Guided, internet-based, rumination-focused cognitive behavioural therapy (i-RFCBT) versus a no-intervention control to prevent depression in high-ruminating young adults, along with an adjunct assessment of the feasibility of unguided i-RFCBT, in the REducing Stress and Preventing Depression trial (RESPOND): study protocol for a phase III randomised controlled trial
Lorna Cook, Edward Watkins
Systemic therapy for vulval Erosive Lichen Planus (the ‘hELP’ trial): study protocol for a randomised controlled trial
Rosalind C. Simpson, Ruth Murphy, Daniel J. Bratton, Matthew R. Sydes, Sally Wilkes, Helen Nankervis, Shelley Dowey, Kim S. Thomas
The efficacy and safety of the Shaoyao Shujin tablet for knee osteoarthritis: study protocol for a randomized controlled trial
Xue-Wei Cao, Da Guo, Jin-Wen Liu, Wei Niu, Jun Liu, Jian-Ke Pan, Hui Xie, Wen-Wei Ouyang, Ding-Kun Lin
A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial
Cesare Cavalera, Francesco Pagnini, Marco Rovaris, Laura Mendozzi, Luigi Pugnetti, Massimo Garegnani, Enrico Molinari
Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial
Nicolien J. Schepers, Olaf J. Bakker, Marc G. H. Besselink, Thomas L. Bollen, Marcel G. W. Dijkgraaf, Casper H. J. van Eijck, Paul Fockens, Erwin J. M. van Geenen, Janneke van Grinsven, Nora D. L. Hallensleben, Bettina E. Hansen, Hjalmar C. van Santvoort, Robin Timmer, Marie-Paule G. F. Anten, Clemens J. M. Bolwerk, Foke van Delft, Hendrik M. van Dullemen, G. Willemien Erkelens, Jeanin E. van Hooft, Robert Laheij, René W. M. van der Hulst, Jeroen M. Jansen, Frank J. G. M. Kubben, Sjoerd D. Kuiken, Lars E. Perk, Rogier J. J. de Ridder, Marno C. M. Rijk, Tessa E. H. Römkens, Erik J. Schoon, Matthijs P. Schwartz, B. W. Marcel Spanier, Adriaan C. I. T. L. Tan, Willem J. Thijs, Niels G. Venneman, Frank P. Vleggaar, Wim van de Vrie, Ben J. Witteman, Hein G. Gooszen, Marco J. Bruno
Statistical design and analysis plan for an impact evaluation of an HIV treatment and prevention intervention for female sex workers in Zimbabwe: a study protocol for a cluster randomised controlled trial
James R. Hargreaves, Elizabeth Fearon, Calum Davey, Andrew Phillips, Valentina Cambiano, Frances M. Cowan
Erratum To: Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial
Meredith A. Achey, Christopher A. Beck, Denise B. Beran, Cynthia M. Boyd, Peter N. Schmidt, Allison W. Willis, Sara S. Riggare, Richard B. Simone, Kevin M. Biglan, E. Ray Dorsey
Effectiveness of an individualized program of muscular strength and endurance with aerobic training for improving germ cell cancer-related fatigue in men undergoing chemotherapy: EFICATEST study protocol for a randomized controlled trial
Antonio Ignacio Cuesta-Vargas, Francisco Carabantes, Zaira Caracuel, Inmaculada Conejo, Emilio Alba
Assessment of the effeCt of lIfestyle iNtervention plus water-soluble ciNnAMon extract On loweriNg blood glucose in pre-diabetics, a randomized, double-blind, multicenter, placebo controlled trial: study protocol for a randomized controlled trial
Paul Crawford, Chuong Thai, Joshua Obholz, Jeffrey Schievenin, Mark True, Sachin A. Shah, John Hallgren, Jill Clark, Danny Sharon
Efficacy study of olmesartan medoxomil on coronary atherosclerosis progression and epicardial adipose tissue volume reduction in patients with coronary atherosclerosis detected by coronary computed tomography angiography: study protocol for a randomized controlled trial
Ying Zhou, Feng Tian, Jing Wang, Jun-Jie Yang, Tao Zhang, Jing Jing, Yun-Dai Chen
Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial
Matthew A. Popplewell, Huw Davies, Hugh Jarrett, Gareth Bate, Margaret Grant, Smitaa Patel, Samir Mehta, Lazaros Andronis, Tracy Roberts, Jon Deeks, Andrew Bradbury
The ethics of future trials: qualitative analysis of physicians’ decision making
Fiona Webster, Charles Weijer, Laura Todd, Jeremy M. Grimshaw, Andrea P. Marshall, Deborah Cook, Graeme MacLennan, Brian H. Cuthbertson, Jill J. Francis
Family-led rehabilitation after stroke in India: the ATTEND trial, study protocol for a randomized controlled trial
Mohammed Alim, Richard Lindley, Cynthia Felix, Dorcas Beulah Chandramathy Gandhi, Shweta Jain Verma, Deepak Kumar Tugnawat, Anuradha Syrigapu, Craig Stuart Anderson, Ramaprabhu Krishnappa Ramamurthy, Peter Langhorne, Gudlavalleti Venkata Satyanarayana Murthy, Bindiganavale Ramaswamy Shamanna, Maree Lisa Hackett, Pallab Kumar Maulik, Lisa Anne Harvey, Stephen Jan, Hueiming Liu, Marion Walker, Anne Forster, Jeyaraj Durai Pandian
Sequential learning of psychomotor and visuospatial skills for laparoscopic suturing and knot tying – study protocol for a randomized controlled trial “The shoebox study”
Jonathan D. Hendrie, Felix Nickel, Thomas Bruckner, Karl-Friedrich Kowalewski, Carly R. Garrow, Maisha Mantel, Philipp Romero, Beat P. Müller-Stich
Temperature-controlled laminar airflow in severe asthma for exacerbation reduction (The LASER Trial): study protocol for a randomised controlled trial
Will Storrar, Carole Fogg, Tom Brown, Paddy Dennison, Ly-Mee Yu, Ann Dewey, Ramon Luengo-Fernandez, Tara Dean, Najib Rahman, Adel Mansur, Peter H. Howarth, Peter Bradding, Anoop J. Chauhan
Comparative effectiveness of antihypertensive treatment for older children with primary hypertension: study protocol for a series of n-of-1 randomized trials
Joyce P. Samuel, Joshua A. Samuels, Lauren E. Brooks, Cynthia S. Bell, Claudia Pedroza, Donald A. Molony, Jon E. Tyson
Patients’ willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey
Sing Yu Moorcraft, Cheryl Marriott, Clare Peckitt, David Cunningham, Ian Chau, Naureen Starling, David Watkins, Sheela Rao
Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial
Phillip J. Tully, Deborah A. Turnbull, John D. Horowitz, John F. Beltrame, Terina Selkow, Bernhard T. Baune, Elizabeth Markwick, Shannon Sauer-Zavala, Harald Baumeister, Suzanne Cosh, Gary A. Wittert
A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project
Paola Mosconi, Gerd Antes, Giorgio Barbareschi, Amanda Burls, Jacques Demotes-Mainard, Iain Chalmers, Cinzia Colombo, Silvio Garattini, Christian Gluud, Gill Gyte, Catherine Mcllwain, Matt Penfold, Nils Post, Roberto Satolli, Maria Rosa Valetto, Brian West, Stephanie Wolff
Combining long-lasting insecticidal nets and indoor residual spraying for malaria prevention in Ethiopia: study protocol for a cluster randomized controlled trial
Wakgari Deressa, Eskindir Loha, Meshesha Balkew, Alemayehu Hailu, Taye Gari, Oljira Kenea, Hans J. Overgaard, Teshome Gebremichael, Bjarne Robberstad, Bernt Lindtjørn
Expanded Access Programme: looking for a common definition
Antonella Iudicello, Lucia Alberghini, Giulia Benini, Paola Mosconi
Is family integrated care in neonatal intensive care units feasible and good for preterm infants in China: study protocol for a cluster randomized controlled trial
Mingyan Hei, Xiangyu Gao, Xirong Gao, Shaohan Nong, Aimin Zhang, Qianshen Zhang, Shoo K. Lee
Process evaluation of a knowledge translation intervention using facilitation of local stakeholder groups to improve neonatal survival in the Quang Ninh province, Vietnam
Leif Eriksson, Tran Q. Huy, Duong M. Duc, Katarina Ekholm Selling, Dinh P. Hoa, Nguyen T. Thuy, Nguyen T. Nga, Lars-Åke Persson, Lars Wallin
The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients (The EMPOWER Trial): study protocol for a randomised controlled trial
Lisa Loughney, Malcolm A. West, Graham J. Kemp, Harry B. Rossiter, Shaunna M. Burke, Trevor Cox, Christopher P. Barben, Michael G. Mythen, Peter Calverley, Daniel H. Palmer, Michael P. W. Grocott, Sandy Jack
Effect of virtual reality exposure therapy on social participation in people with a psychotic disorder (VRETp): study protocol for a randomized controlled trial
Roos Pot-Kolder, Wim Veling, Chris Geraets, Mark van der Gaag
Culturally adaptive storytelling method to improve hypertension control in Vietnam - “We talk about our hypertension”: study protocol for a feasibility cluster-randomized controlled trial
Jeroan J. Allison, Hoa L. Nguyen, Duc A. Ha, Germán Chiriboga, Ha N. Ly, Hanh T. Tran, Ngoc T. Phan, Nguyen C. Vu, Minjin Kim, Robert J. Goldberg
Guidelines for reporting embedded recruitment trials
Vichithranie W. Madurasinghe
Simple steps to develop trial follow-up procedures
Ona McCarthy, Rebecca S. French, Ian Roberts, Caroline Free
Dipeptidyl peptidase-4 inhibition and narrow-band ultraviolet-B light in psoriasis (DINUP): study protocol for a randomised controlled trial
Maeve Lynch, Tomás B. Ahern, Irene Timoney, Cheryl Sweeney, Genevieve Kelly, Rosalind Hughes, Anne-Marie Tobin, Donal O’Shea, Brian Kirby
PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial
Christopher M. Halloran, Kellie Platt, Abbie Gerard, Fotis Polydoros, Derek A. O’Reilly, Dhanwant Gomez, Andrew Smith, John P. Neoptolemos, Zahir Soonwalla, Mark Taylor, Jane M. Blazeby, Paula Ghaneh
Characterisation of trials where marketing purposes have been influential in study design: a descriptive study
Virginia Barbour, Druin Burch, Fiona Godlee, Carl Heneghan, Richard Lehman, Rafael Perera, Joseph S. Ross, Sara Schroter
Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory
Karin E. Johnson, Gila Neta, Laura M. Dember, Gloria D. Coronado, Jerry Suls, David A. Chambers, Sean Rundell, David H. Smith, Benmei Liu, Stephen Taplin, Catherine M. Stoney, Margaret M. Farrell, Russell E. Glasgow
Effectiveness of a behavioral incentive scheme linked to goal achievement: study protocol for a randomized controlled trial
Julie Redfern, Gemma Enright, Simon Raadsma, Margaret Allman-Farinelli, Christine Innes-Hughes, Santosh Khanal, Sarah Lukeis, Chris Rissel, Alex Gyani
The role of primary tumor resection in colorectal cancer patients with asymptomatic, synchronous unresectable metastasis: Study protocol for a randomized controlled trial
Chang Woo Kim, Jeong-Heum Baek, Gyu-Seog Choi, Chang Sik Yu, Sung Bum Kang, Won Cheol Park, Bong Hwa Lee, Hyeong Rok Kim, Jae Hwan Oh, Jae-Hwang Kim, Seung-Yong Jeong, Jung Bae Ahn, Seung Hyuk Baik
Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy)
Emily Harrop, John Kelly, Gareth Griffiths, Angela Casbard, Annmarie Nelson
Spectacle wearing in children randomised to ready-made or custom spectacles, and potential cost savings to programmes: study protocol for a randomised controlled trial
Priya Morjaria, Kaushik Murali, Jennifer Evans, Clare Gilbert
Evaluation of alternative school feeding models on nutrition, education, agriculture and other social outcomes in Ghana: rationale, randomised design and baseline data
Aulo Gelli, Edoardo Masset, Gloria Folson, Anthoni Kusi, Daniel K. Arhinful, Felix Asante, Irene Ayi, Kwabena M. Bosompem, Kristie Watkins, Lutuf Abdul-Rahman, Rosanna Agble, Getrude Ananse-Baden, Daniel Mumuni, Elisabetta Aurino, Meena Fernandes, Lesley Drake
Are glucose levels, glucose variability and autonomic control influenced by inspiratory muscle exercise in patients with type 2 diabetes? Study protocol for a randomized controlled trial
ASO Schein, APS Correa, Karina Rabello Casali, Beatriz D. Schaan
Erratum to: The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction
Toni Zhong, Claire Temple-Oberle, Stefan O. P. Hofer, Brett Beber, John Semple, Mitchell Brown, Sheina Macadam, Peter Lennox, Tony Panzarella, Colleen McCarthy, Nancy Baxter
Erratum to: ‘The Memory Aid study: protocol for a randomized controlled clinical trial evaluating the effect of computer-based working memory training in elderly patients with mild cognitive impairment (MCI)’
Marianne M. Flak, Susanne S. Hernes, Linda Chang, Thomas Ernst, Vanessa Douet, Jon Skranes, Gro C. C. Løhaugen
Erratum to: ‘Effect of a high-dose target-controlled naloxone infusion on pain and hyperalgesia in patients following groin hernia repair: study protocol for a randomized controlled trial’
Manuel Pedro Pereira, Mads Utke Werner, Joergen Berg Dahl
Erratum to: ‘The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial’
Rebecca Sudore, Gem M. Le, Ryan McMahan, Mariko Feuz, Mary Katen, Deborah E. Barnes
Erratum to: ‘TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial’
Dylan R. Morris, Margaret A. Cunningham, Anna A. Ahimastos, Bronwyn A. Kingwell, Elise Pappas, Michael Bourke, Christopher M. Reid, Theo Stijnen, Ronald L. Dalman, Oliver O. Aalami, Jan H. Lindeman, Paul E. Norman, Philip J. Walker, Robert Fitridge, Bernie Bourke, Anthony E. Dear, Jenna Pinchbeck, Rene Jaeggi, Jonathan Golledge
Effects of the pattern of glucocorticoid replacement on neural processing, emotional reactivity and well-being in healthy male individuals: study protocol for a randomised controlled trial
Konstantinos Kalafatakis, Georgina M. Russell, Catherine J. Harmer, Marcus R. Munafo, Nicky Marchant, Aileen Wilson, Jonathan C. W. Brooks, Ngoc J. Thai, Stuart G. Ferguson, Kirsty Stevenson, Claire Durant, Kristin Schmidt, Stafford L. Lightman
Effects of postoperative administration of celecoxib on pain management in patients after total knee arthroplasty: study protocol for an open-label randomized controlled trial
Takeo Mammoto, Keiko Fujie, Naotaka Mamizuka, Noriko Taguchi, Atsushi Hirano, Masashi Yamazaki, Satoshi Ueno, Enbo Ma, Koichi Hashimoto
Prospective analysis of UGT1A1 promoter polymorphism for irinotecan dose escalation in metastatic colorectal cancer patients treated with bevacizumab plus FOLFIRI as the first-line setting: study protocol for a randomized controlled trial
Yung-Sung Yeh, Hsiang-Lin Tsai, Ching-Wen Huang, Jui-Ho Wang, Yi-Wen Lin, Hsiu-Chih Tang, Yung-Chuan Sung, Chang-Chieh Wu, Chien-Yu Lu, Jaw-Yuan Wang
Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients
Dieter Rixen, Eva Steinhausen, Stefan Sauerland, Rolf Lefering, Marc G. Maegele, Bertil Bouillon, Guido Grass, Edmund A. M. Neugebauer
Chitosan nerve tube for primary repair of traumatic sensory nerve lesions of the hand without a gap: study protocol for a randomized controlled trial
Florian Neubrech, Sina Heider, Leila Harhaus, Berthold Bickert, Ulrich Kneser, Thomas Kremer
Working memory and processing speed training in schizophrenia: study protocol for a randomized controlled trial
Briana D. Cassetta, Vina M. Goghari
Non-invasive programmed stimulation to identify high-risk patients with implanted cardioverter defibrillator (the NIPS-ICD study): study protocol for a randomized controlled trial
Piotr Futyma, Marian Futyma, Piotr Kułakowski
Improving delivery of secondary prophylaxis for rheumatic heart disease in remote Indigenous communities: study protocol for a stepped-wedge randomised trial
Anna P. Ralph, Clancy Read, Vanessa Johnston, Jessica L. de Dassel, Kerstin Bycroft, Alice Mitchell, Ross S. Bailie, Graeme P. Maguire, Keith Edwards, Bart J. Currie, Adrienne Kirby, Jonathan R. Carapetis
Translating knowledge for action against stroke – using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke)
Ayeesha Kamran Kamal, Adeel Khoja, Bushra Usmani, Abdul Muqeet, Fabiha Zaidi, Masood Ahmed, Saadia Shakeel, Nabila Soomro, Ambreen Gowani, Nargis Asad, Asma Ahmed, Saleem Sayani, Iqbal Azam, Sarah Saleem
PRECISE — pregabalin in addition to usual care: statistical analysis plan
Stephanie Mathieson, Laurent Billot, Christopher G. Maher, Andrew J. McLachlan, Jane Latimer, Bart W. Koes, Mark J. Hancock, Ian Harris, Richard O. Day, Justin Pik, Stephen Jan, Chung-Wei Christine Lin
Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial
Roshan das Nair, Pippa Anderson, Simon Clarke, Paul Leighton, Nadina B. Lincoln, Jacqueline R. Mhizha-Murira, Brigitte E. Scammell, David A. Walsh
The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial
Andrew H. Ford, Leon Flicker, Jurgen Passage, Bradley Wibrow, Matthew Anstey, Mark Edwards, Osvaldo P. Almeida
Stroke Treatment Associated with Rehabilitation Therapy and Transcranial DC Stimulation (START-tDCS): a study protocol for a randomized controlled trial
Suellen M. Andrade, Natanael A. Santos, Bernardino Fernández-Calvo, Paulo S. Boggio, Eliane A. Oliveira, José J. Ferreira, Amanda Sobreira, Felipe Morgan, Germana Medeiros, Gyovanna S. Cavalcanti, Ingrid D. Gadelha, Jader Duarte, Joercia Marrocos, Michele A. Silva, Thatiana Rufino, Sanmy R. Nóbrega
Polypharmacy in chronic diseases–Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial
Andreas Sönnichsen, Ulrike S. Trampisch, Anja Rieckert, Giuliano Piccoliori, Anna Vögele, Maria Flamm, Tim Johansson, Aneez Esmail, David Reeves, Christin Löffler, Jennifer Höck, Renate Klaassen-Mielke, Hans Joachim Trampisch, Ilkka Kunnamo
Perspectives on the design and methodology of periconceptional nutrient supplementation trials
Bernard J. Brabin, Sabine Gies, Stephen Owens, Yves Claeys, Umberto D’Alessandro, Halidou Tinto, Loretta Brabin
Assessing the effectiveness of enhanced psychological care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): study protocol for a pilot cluster randomised controlled trial
Suzanne H. Richards, Chris Dickens, Rob Anderson, David A. Richards, Rod S. Taylor, Obioha C. Ukoumunne, David Kessler, Katrina Turner, Willem Kuyken, Manish Gandhi, Luke Knight, Andrew Gibson, Antoinette Davey, Fiona Warren, Rachel Winder, Christine Wright, John Campbell
Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial
Alexander Miloff, Philip Lindner, William Hamilton, Lena Reuterskiöld, Gerhard Andersson, Per Carlbring
Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial
Pètra Braam, Philippe Lambin, Johan Bussink
Neural correlates of working memory training in HIV patients: study protocol for a randomized controlled trial
L Chang, GC Løhaugen, V Douet, EN Miller, J Skranes, T Ernst
Erratum to: ‘Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial
Denise A. Yardley, Adam Brufsky, Robert E. Coleman, Pierfranco F. Conte, Javier Cortes, Stefan Glück, Jean-Mark A. Nabholtz, Joyce O’Shaughnessy, Robert M. Beck, Amy Ko, Markus F. Renschler, Debora Barton, Nadia Harbeck
Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial
Chinwe Onu, Linnet Ongeri, Elizabeth Bukusi, Craig R. Cohen, Thomas C. Neylan, Patrick Oyaro, Grace Rota, Faith Otewa, Kevin L. Delucchi, Susan M. Meffert
Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial
Jennifer Wenborn, Sinéad Hynes, Esme Moniz-Cook, Gail Mountain, Fiona Poland, Michael King, Rumana Omar, Steven Morris, Myrra Vernooij-Dassen, David Challis, Susan Michie, Ian Russell, Catherine Sackley, Maud Graff, Aidan O’Keeffe, Nadia Crellin, Martin Orrell
Mirtazapine added to selective serotonin reuptake inhibitors for treatment-resistant depression in primary care (MIR trial): study protocol for a randomised controlled trial
Debbie Tallon, Nicola Wiles, John Campbell, Carolyn Chew-Graham, Chris Dickens, Una Macleod, Tim J. Peters, Glyn Lewis, Ian M. Anderson, Simon Gilbody, William Hollingworth, Simon Davies, David Kessler
National Safety Associates nutritional supplementation trial of fruit and vegetable extracts and vascular function (NNTV): study protocol for a randomised controlled trial
Marietta Sayegh, Melina Tsiountsioura, Polly Page, Dan Del Rio, Sumantra Ray
Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial
Sheri A. Lippman, Starley B. Shade, Jeri Sumitani, Julia DeKadt, Jennifer M. Gilvydis, Mary Jane Ratlhagana, Jessica Grignon, John Tumbo, Hailey Gilmore, Emily Agnew, Parya Saberi, Scott Barnhart, Wayne T. Steward
Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth – the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial
Fausto Medeiros Mendes, Laura Regina Antunes Pontes, Thais Gimenez, Juan Sebastian Lara, Lucila Basto de Camargo, Edgard Michel-Crosato, Claudio Mendes Pannuti, Daniela Prócida Raggio, Mariana Minatel Braga, Tatiane Fernandes Novaes
Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial
Christine M. Goertz, Cynthia R. Long, Robert D. Vining, Katherine A. Pohlman, Bridget Kane, Lance Corber, Joan Walter, Ian Coulter
Negotiating excess treatment costs in a clinical research trial: the good, the bad and the innovative
Rebecca Palmer, Madeleine Harrison, Elizabeth Cross, Pam Enderby
Statistical analysis and handling of missing data in cluster randomized trials: a systematic review
Mallorie H. Fiero, Shuang Huang, Eyal Oren, Melanie L. Bell
Dental practitioner recruitment for a randomized clinical trial in the field to evaluate the performance of a new glass ionomer restoration material
Thomas Klinke, Amro Daboul, Christian Schwahn, Roland Frankenberger, Reinhard Hickel, Reiner Biffar
Progressive postresection program (pPRP) after pancreatic resection: study protocol for a randomized controlled trial
Susanne Richter, Verena Uslar, Navid Tabriz, Thomas Mueser, Dirk Weyhe
Comparison of the influence of ticagrelor and clopidogrel on inflammatory biomarkers and vascular endothelial function for patients with ST-segment elevation myocardial infarction receiving emergency percutaneous coronary intervention: study protocol for a randomized controlled trial
Zhenhua Li, Yueyan Li, Tao Zhang, Wei Miao, Guohai Su
Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial
Charlotte Hanlon, Atalay Alem, Girmay Medhin, Teshome Shibre, Dawit A. Ejigu, Hanna Negussie, Michael Dewey, Lawrence Wissow, Martin Prince, Ezra Susser, Crick Lund, Abebaw Fekadu
Acceptance and commitment therapy for adults with advanced cancer (CanACT): study protocol for a feasibility randomised controlled trial
Joseph Low, Marc Serfaty, Sarah Davis, Victoria Vickerstaff, Anna Gola, Rumana Z. Omar, Michael King, Adrian Tookman, Janet St John Austen, Karen Turner, Louise Jones
Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency
Peter Doshi, Tom Jefferson
Investigating the feasibility and acceptability of a cognitive behavioural suicide prevention therapy for people in acute psychiatric wards (the ‘INSITE’ trial): study protocol for a randomised controlled trial
Gillian Haddock, Linda Davies, Emma Evans, Richard Emsley, Patricia Gooding, Lisa Heaney, Sarah Jones, James Kelly, Ailsa Munro, Sarah Peters, Daniel Pratt, Nicholas Tarrier, Kirsten Windfuhr, Yvonne Awenat
Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study): study protocol for a cluster randomised controlled trial
David Osborn, Alexandra Burton, Kate Walters, Irwin Nazareth, Samira Heinkel, Lou Atkins, Ruth Blackburn, Richard Holt, Racheal Hunter, Michael King, Louise Marston, Susan Michie, Richard Morris, Steve Morris, Rumana Omar, Robert Peveler, Vanessa Pinfold, Ella Zomer, Thomas Barnes, Tom Craig, Hazel Gilbert, Ben Grey, Claire Johnston, Judy Leibowitz, Irene Petersen, Fiona Stevenson, Sheila Hardy, Vanessa Robinson
Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial
Shinichi Amano, Arimi Fitri Mat Ludin, Rachel Clift, Masato Nakazawa, Timothy D. Law, Laura J. Rush, Todd M. Manini, James S. Thomas, David W. Russ, Brian C. Clark
Improving access to primary care for Aboriginal babies in Western Australia: study protocol for a randomized controlled trial
Daniel McAullay, Kimberley McAuley, Rhonda Marriott, Glenn Pearson, Peter Jacoby, Chantal Ferguson, Elizabeth Geelhoed, Juli Coffin, Charmaine Green, Selina Sibosado, Barbara Henry, Dorota Doherty, Karen Edmond
Erratum to: ‘Screen-and-treat program by point-of-care of Atopobium vaginae and Gardnerella vaginalis in preventing preterm birth (AuTop trial): study protocol for a randomized controlled trial’
Florence Bretelle, Florence Fenollar, Karine Baumstarck, Cécile Fortanier, Jean François Cocallemen, Valérie Serazin, Didier Raoult, Pascal Auquier, Sandrine Loubière
Study of endothelial function response to exercise training in hypertensive individuals (SEFRET): study protocol for a randomized controlled trial
Marinei Lopes Pedralli, Gustavo Waclawovsky, Augusto Camacho, Melissa Medeiros Markoski, Iran Castro, Alexandre Machado Lehnen
Implementation of a telephone-based secondary preventive intervention after acute coronary syndrome (ACS): participation rate, reasons for non-participation and 1-year survival
Daniel Huber, Robin Henriksson, Stina Jakobsson, Nikolai Stenfors, Thomas Mooe
Thanks to all those who reviewed for Trials in 2015
Douglas G. Altman, Curt D. Furberg, Jeremy M. Grimshaw
Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial
Pierre Kalfon, Olivier Mimoz, Anderson Loundou, Marie-Agnès Geantot, Nathalie Revel, Isabelle Villard, Julien Amour, Elie Azoulay, Maïté Garrouste-Orgeas, Claude Martin, Tarek Sharshar, Karine Baumstarck, Pascal Auquier
Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial
Godfrey B. Woelk, Mary Pat Kieffer, Damilola Walker, Daphne Mpofu, Rhoderick Machekano
Erratum to: ‘Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial’
A. Solari, A. Giordano, M. G. Grasso, P. Confalonieri, F. Patti, A. Lugaresi, L. Palmisano, R. Amadeo, G. Martino, M. Ponzio, G. Casale, C. Borreani, R. Causarano, S. Veronese, P. Zaratin, M. A. Battaglia
One-stage or two-stage revision surgery for prosthetic hip joint infection – the INFORM trial: a study protocol for a randomised controlled trial
Simon Strange, Michael R. Whitehouse, Andrew D. Beswick, Tim Board, Amanda Burston, Ben Burston, Fran E. Carroll, Paul Dieppe, Kirsty Garfield, Rachael Gooberman-Hill, Stephen Jones, Setor Kunutsor, Athene Lane, Erik Lenguerrand, Alasdair MacGowan, Andrew Moore, Sian Noble, Joanne Simon, Ian Stockley, Adrian H. Taylor, Andrew Toms, Jason Webb, John-Paul Whittaker, Matthew Wilson, Vikki Wylde, Ashley W. Blom
Physical therapy aimed at self-management versus usual care physical therapy after hip arthroscopy for femoroacetabular impingement: study protocol for a randomized controlled trial
M. Tijssen, R. E. H. van Cingel, J. B. Staal, S. Teerenstra, E. de Visser, M. W. G. Nijhuis-van der Sanden
Design and rationale of the ATHENA study – A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial
Claudia Sommerer, Barbara Suwelack, Duska Dragun, Peter Schenker, Ingeborg A. Hauser, Björn Nashan, Friedrich Thaiss
Evaluation of an antenatal acupuncture intervention as an adjunct therapy for antenatal depression (AcuAnteDep): study protocol for a pragmatic randomised controlled trial
Simone M. Ormsby, Caroline A. Smith, Hannah G. Dahlen, Phillipa J. Hay, Joanne M. Lind
Interventions to improve patients’ compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions
Luciana Verçoza Viana, Marilia Brito Gomes, Lenita Zajdenverg, Elizabeth Joao Pavin, Mirela Jobim Azevedo
Erratum to: ‘Perioperative use of crystalloids in patients undergoing open radical cystectomy: balanced Ringer’s maleate versus a glucose 5 %/potassium-based balanced solution: study protocol for a randomized controlled trial’
Lukas M. Löffel, Bettina Kleeb, Fiona C. Burkhard, Patrick Y. Wuethrich
Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial
Camille Giovancarli, Eric Malbos, Karine Baumstarck, Nathalie Parola, Marie-Florence Pélissier, Christophe Lançon, Pascal Auquier, Laurent Boyer
The combined effect of subcutaneous granulocyte- colony stimulating factor and myocardial contrast echocardiography with intravenous infusion of sulfur hexafluoride on post-infarction left ventricular function, the RIGENERA 2.0 trial: study protocol for a randomized controlled trial
Antonio Maria Leone, Domenico D’Amario, Luciana Teofili, Eloisa Basile, Francesco Cannata, Francesca Graziani, Mario Marzilli, Antonio Matteo Russo, Giuseppe Tarantini, Claudio Ceconi, Giuseppe Leone, Carlo Trani, Antonio Giuseppe Rebuzzi, Filippo Crea
Intravenous magnesium sulfate for the management of severe hand, foot, and mouth disease with autonomic nervous system dysregulation in Vietnamese children: study protocol for a randomized controlled trial
Phan Tu Qui, Truong Huu Khanh, Huynh Trung Trieu, Phạm Thanh Giang, Nguyen Ngọc Bich, Le Phan Kim Thoa, Le Nguyen Thanh Nhan, Saraswathy Sabanathan, Rogier Van Doorn, Nguyen Duc Toan, Laura Merson, Nguyen Thi Phuong Dung, Lam Phung Khanh, Marcel Wolbers, Nguyen Thanh Hung, Nguyen Van Vinh Chau, Bridget Wills
Efficacy and safety of Qi-Wei-Qing-Yan aerosol in treatment of acute pharyngitis (lung-stomach excess-heat syndrome): study protocol for a randomized controlled trial
Hong-li Jiang, Bin She, Wei Liu, Bing Mao, Ju-ying Zhang
From protocol to published report: a study of consistency in the reporting of academic drug trials
Louise Berendt, Torbjörn Callréus, Lene Grejs Petersen, Karin Friis Bach, Henrik Enghusen Poulsen, Kim Dalhoff
Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial
Nancy Kentish-Barnes, Sylvie Chevret, Elie Azoulay
Impact of preoperative Vitamin D3 administration on postoperative hypocalcaemia in patients undergoing total thyroidectomy (HypoCalViD): study protocol for a randomized controlled trial
Stefanie Wolak, Mandy Scheunchen, Katharina Holzer, Mirjam Busch, Esra Trumpf, Andreas Zielke
The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial
Cynthia Pine, Pauline Adair, Louise Robinson, Girvan Burnside, Paula Moynihan, William Wade, James Kistler, Morag Curnow, Mary Henderson
Recruiting to a large-scale physical activity randomised controlled trial – experiences with the gift of hindsight
Robert J. Copeland, Kimberley Horspool, Liam Humphreys, Emma Scott
Effect of rehabilitation worker input on visual function outcomes in individuals with low vision: study protocol for a randomised controlled trial
Jennifer H. Acton, Bablin Molik, Alison Binns, Helen Court, Tom H. Margrain
Activating clinical trials: a process improvement approach
Diego A. Martinez, Athanasios Tsalatsanis, Ali Yalcin, José L. Zayas-Castro, Benjamin Djulbegovic
Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies
Louisa Edwards, Chris Salisbury, Kimberley Horspool, Alexis Foster, Katy Garner, Alan A. Montgomery
A prospective multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART Disc plus autologous disc chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disc to avoid secondary disease: study protocol for a randomized controlled trial
Anja Tschugg, Felix Michnacs, Martin Strowitzki, Hans Jörg Meisel, Claudius Thomé
Erratum to: ‘Novel patient engagement and recruitment strategies for an RCT of two NHS treatments for ankle osteoarthritis - total ankle replacement versus arthrodesis - the TARVA trial’
Andy Goldberg, Claire Thomson, Deirdre Brooking, Elin Rees, Marion Cumbers, Michelle Tetlow, Simon Skene, Suzie Cro
A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial
Simone Vigod, Neesha Hussain-Shamsy, Sophie Grigoriadis, Louise M. Howard, Kelly Metcalfe, Tim F. Oberlander, Carrie Schram, Donna E. Stewart, Valerie H. Taylor, Cindy-Lee Dennis
RiMINI – the influence of rifaximin on minimal hepatic encephalopathy (MHE) and on the intestinal microbiome in patients with liver cirrhosis: study protocol for a randomized controlled trial
Christian Schulz, Kerstin Schütte, Siegfried Kropf, Friedhelm C. Schmitt, Riccardo Vasapolli, Leon M. Kliegis, Antonia Riegger, Peter Malfertheiner
Impact of routine coronary catheterization in low extremity artery disease undergoing percutaneous transluminal angioplasty: study protocol for a multi-center randomized controlled trial
I-Chih Chen, Cheng-Han Lee, Ting-Hsing Chao, Wei-Kung Tseng, Tsung-Hsien Lin, Wen-Jung Chung, Jen-Kwan Li, Hsuan-Li Huang, Ping-Yen Liu, Ting-Kuang Chao, Chuin-Yuan Chu, Chih-Chan Lin, Po-Chao Hsu, Wen-Huang Lee, Po-Tseng Lee, Yi-Heng Li, Shih-Ya Tseng, Liang-Miin Tsai, Juey-Jen Hwang
The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial
Marc Serfaty, Michael King, Irwin Nazareth, Adrian Tookman, John Wood, Anna Gola, Trefor Aspden, Kathryn Mannix, Sarah Davis, Stirling Moorey, Louise Jones
APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial
Eva M. Conceição, Paulo P. P. Machado, Ana Rita Vaz, Ana Pinto-Bastos, Sofia Ramalho, Cátia Silva, Filipa Arrojado
Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial
Cherry-Ann Waldron, Emma Thomas-Jones, Rebecca Cannings-John, Kerenza Hood, Colin Powell, Amanda Roberts, Alun Tomkinson, Deborah Fitzsimmons, Micaela Gal, Debbie Harris, Victoria Shepherd, Christopher C Butler, Nicholas Francis
Oxford Lithium Trial (OxLith) of the early affective, cognitive, neural and biochemical effects of lithium carbonate in bipolar disorder: study protocol for a randomised controlled trial
Kate E. A. Saunders, Andrea Cipriani, Jennifer Rendell, Mary-Jane Attenburrow, Natalie Nelissen, Amy C. Bilderbeck, Sridhar R. Vasudevan, Grant Churchill, Guy M. Goodwin, Anna C. Nobre, Catherine J. Harmer, Paul J. Harrison, John R. Geddes
On-site bundled rapid HIV/HCV testing in substance use disorder treatment programs: study protocol for a hybrid design randomized controlled trial
Jemima A. Frimpong, Thomas D’Aunno, David C. Perlman, Shiela M. Strauss, Alissa Mallow, Diana Hernandez, Bruce R. Schackman, Daniel J. Feaster, Lisa R. Metsch
Sequential psychological and pharmacological therapies for comorbid and primary insomnia: study protocol for a randomized controlled trial
Charles M. Morin, Jack D. Edinger, Andrew D. Krystal, Daniel J. Buysse, Simon Beaulieu-Bonneau, Hans Ivers
A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial
Penelope Abbott, Hasantha Gunasekera, Amanda Jane Leach, Deborah Askew, Robyn Walsh, Kelvin Kong, Federico Girosi, Chelsea Bond, Peter Morris, Sanja Lujic, Wendy Hu, Tim Usherwood, Sissy Tyson, Geoffrey Spurling, Markeeta Douglas, Kira Schubert, Shavaun Chapman, Nadeem Siddiqui, Reeion Murray, Keitha Rabbitt, Bobby Porykali, Cheryl Woodall, Tina Newman, Jennifer Reath
Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial
B. Joseph Elmunzer, Jose Serrano, Amitabh Chak, Steven A. Edmundowicz, Georgios I. Papachristou, James M. Scheiman, Vikesh K. Singh, Shyam Varadurajulu, John J. Vargo, Field F. Willingham, Todd H. Baron, Gregory A. Coté, Joseph Romagnuolo, April Wood-Williams, Emily K. Depue, Rebecca L. Spitzer, Cathie Spino, Lydia D. Foster, Valerie Durkalski
Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) – study protocol for a randomized controlled trial
Ayeesha Kamran Kamal, Abdul Muqeet, Kashfa Farhat, Wardah Khalid, Anum Jamil, Ambreen Gowani, Aliya Amin Muhammad, Fabiha Zaidi, Danyal Khan, Touseef Elahi, Shahrukh Sharif, Sibtain Raz, Taha Zafar, Syedah Saira Bokhari, Nasir Rahman, Fateh Ali Tipoo Sultan, Saleem Sayani, Salim S. Virani
Clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns: study protocol for a randomized controlled trial
Zjir M. Rashaan, Pieta Krijnen, M. Elske van den Akker- van Marle, Margriet E. van Baar, Adrianus F. P. Vloemans, Jan Dokter, Fenike R. H. Tempelman, Cees H. van der Vlies, Roelf S. Breederveld
Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial
Lucy Hackshaw-McGeagh, J. Athene Lane, Raj Persad, David Gillatt, Jeff M. P. Holly, Anthony Koupparis, Edward Rowe, Lyndsey Johnston, Jenny Cloete, Constance Shiridzinomwa, Paul Abrams, Chris M. Penfold, Amit Bahl, Jon Oxley, Claire M. Perks, Richard Martin
A multicenter randomized controlled open-label trial to assess the efficacy of compound kushen injection in combination with single-agent chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer: study protocol for a randomized controlled trial
Xue-qian Wang, Jie Liu, Hong-sheng Lin, Wei Hou
The functional and clinical outcomes of exercise training following a very low energy diet for severely obese women: study protocol for a randomised controlled trial
Clint T. Miller, Steve F. Fraser, Steve E. Selig, Toni Rice, Mariee Grima, Nora E. Straznicky, Itamar Levinger, Elisabeth A. Lambert, Daniel J. van den Hoek, John B. Dixon
Erratum to: ‘Effectiveness of a behavioral incentive scheme linked to goal achievement: study protocol for a randomized controlled trial’
Julie Redfern, Gemma Enright, Simon Raadsma, Margaret Allman-Farinelli, Christine Innes-Hughes, Santosh Khanal, Sarah Lukeis, Chris Rissel, Alex Gyani
Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer (PREOPANC trial): study protocol for a multicentre randomized controlled trial
Eva Versteijne, Casper H. J. van Eijck, Cornelis J. A. Punt, Mustafa Suker, Aeilko H. Zwinderman, Miriam A. C. Dohmen, Karin B. C. Groothuis, Oliver R. C. Busch, Marc G. H. Besselink, Ignace H. J. T. de Hingh, Albert J. ten Tije, Gijs A. Patijn, Bert A. Bonsing, Judith de Vos-Geelen, Joost M. Klaase, Sebastiaan Festen, Djamila Boerma, Joris I. Erdmann, I. Quintus. Molenaar, Erwin van der Harst, Marion B. van der Kolk, Coen R. N. Rasch, Geertjan van Tienhoven
The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial
Kate Jongbloed, Anton J. Friedman, Margo E. Pearce, Mia L. Van Der Kop, Vicky Thomas, Lou Demerais, Sherri Pooyak, Martin T. Schechter, Richard T. Lester, Patricia M. Spittal
Effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial spasm compared to standard care: study protocol for a randomised controlled trial
Sadie Wickwar, Hayley McBain, Stanton P. Newman, Shashivadan P. Hirani, Catherine Hurt, Nicola Dunlop, Chris Flood, Daniel G. Ezra
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
Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention
Bethan Copsey, Sally Hopewell, Clemens Becker, Ian D. Cameron, Sarah E. Lamb
The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial
Alice M. Couwenberg, Maarten J. P. Burbach, Anke B. Smits, Marco Van Vulpen, Wilhemina M. U. Van Grevenstein, Peter G. Noordzij, Helena M. Verkooijen
Erratum to: ‘Recruitment challenges in clinical research including cancer patients and their caregivers. A randomized controlled trial study and lessons learned’
Karin Sygna, Safora Johansen, Cornelia M. Ruland
The efficacy of a new translational treatment for persecutory delusions: study protocol for a randomised controlled trial (The Feeling Safe Study)
Daniel Freeman, Felicity Waite, Richard Emsley, David Kingdon, Linda Davies, Ray Fitzpatrick, Graham Dunn
Community and District Empowerment for Scale-up (CODES): a complex district-level management intervention to improve child survival in Uganda: study protocol for a randomized controlled trial
Peter Waiswa, Thomas O’Connell, Danstan Bagenda, Pricila Mullachery, Flavia Mpanga, Dorcus Kiwanuka Henriksson, Anne Ruhweza Katahoire, Eric Ssegujja, Anthony K. Mbonye, Stefan Swartling Peterson
Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial
Kathryn Eve Lewandowski, Sarah H. Sperry, Dost Ongur, Bruce M. Cohen, Lesley A. Norris, Matcheri S. Keshavan
RECCAS - REmoval of Cytokines during CArdiac Surgery: study protocol for a randomised controlled trial
Andreas Baumann, Dirk Buchwald, Thorsten Annecke, Martin Hellmich, Peter K Zahn, Andreas Hohn
Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial
Areti Angeliki Veroniki, Sharon E. Straus, Huda Ashoor, Lesley A. Stewart, Mike Clarke, Andrea C. Tricco
Beneficial effect of xylose consumption on postprandial hyperglycemia in Korean: a randomized double-blind, crossover design
Yun Ju Jun, Jinhee Lee, Sehee Hwang, Jung Hyun Kwak, Hyeon Yeong Ahn, Youn Kyung Bak, Jihoon Koh, Jong Ho Lee
Oral PSORI-CM01, a Chinese herbal formula, plus topical sequential therapy for moderate-to-severe psoriasis vulgaris: pilot study for a double-blind, randomized, placebo-controlled trial
Dan-Ni Yao, Chuan-Jian Lu, Ze-Huai Wen, Yu-Hong Yan, Mei-Ling Xuan, Xiao-Yan Li, Geng Li, Ze-Hui He, Xiu-Li Xie, Jing-Wen Deng, Xin-Feng Guo, Ai-Hua Ou
Glutamatergic medication in the treatment of obsessive compulsive disorder (OCD) and autism spectrum disorder (ASD) – study protocol for a randomised controlled trial
Alexander Häge, Tobias Banaschewski, Jan K. Buitelaar, Rick M. Dijkhuizen, Barbara Franke, David J. Lythgoe, Konstantin Mechler, Steven C. R. Williams, Ralf W. Dittmann
Xuebijing injection in the treatment of severe pneumonia: study protocol for a randomized controlled trial
Ping Wang, Yuanlin Song, Zhi Liu, Hui Wang, Wenke Zheng, Si Liu, Zhiqiao Feng, Jingbo Zhai, Chen Yao, Ming Ren, Chunxue Bai, Hongcai Shang
Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial
Mariana Widmer, Gilda Piaggio, Hany Abdel-Aleem, Guillermo Carroli, Yap-Seng Chong, Arri Coomarasamy, Bukola Fawole, Shivaprasad Goudar, G. Justus Hofmeyr, Pisake Lumbiganon, Kidza Mugerwa, Thi My Huong Nguyen, Zahida Qureshi, Joao Paulo Souza, A. Metin Gülmezoglu
Efficacy of an educational intervention in primary health care in inhalation techniques: study protocol for a pragmatic cluster randomised controlled trial
José Leiva-Fernández, Rubén L. Vázquez-Alarcón, Virginia Aguiar-Leiva, Mireya Lobnig-Becerra, Francisca Leiva-Fernández, Pilar Barnestein-Fonseca
A behavioural change package to prevent hand dermatitis in nurses working in the national health service (the SCIN trial): study protocol for a cluster randomised controlled trial
Ira Madan, Vaughan Parsons, Barry Cookson, John English, Tina Lavender, Paul McCrone, Caroline Murphy, Georgia Ntani, Lesley Rushton, Julia Smedley, Hywel Williams, Alison Wright, David Coggon
The biomechanical effect of acupuncture for poststroke cavovarus foot: study protocol for a randomized controlled pilot trial
Yong Zhang, Hongwei Liu, Caihong Fu, Yanzhe Ning, Jiajia Zhang, Li Zhou, Zongheng Li, Peng Bai
Dorsal penile nerve block for rigid cystoscopy in men: study protocol for a randomized controlled trial
Yan Qiu, An-min Hu, Jin Liu, Gui-zhi Du
Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (The ELAIN-Trial): study protocol for a randomized controlled trial
Alexander Zarbock, Joachim Gerß, Hugo Van Aken, Andreea Boanta, John A. Kellum, Melanie Meersch
Sample size calculations in clinical research should also be based on ethical principles
Bruno Mario Cesana, Paolo Antonelli
Adaptive designs undertaken in clinical research: a review of registered clinical trials
Isabella Hatfield, Annabel Allison, Laura Flight, Steven A. Julious, Munyaradzi Dimairo
Erratum to: ‘Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial’
Chinwe Onu, Linnet Ongeri, Elizabeth Bukusi, Craig R. Cohen, Thomas C. Neylan, Patrick Oyaro, Grace Rota, Faith Otewa, Kevin L. Delucchi, Susan M. Meffert
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
Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: study protocol for a randomized controlled trial
Linda Worrall, Brooke Ryan, Kyla Hudson, Ian Kneebone, Nina Simmons-Mackie, Asaduzzaman Khan, Tammy Hoffmann, Emma Power, Leanne Togher, Miranda Rose
An Ecological Momentary Intervention for weight loss and healthy eating via smartphone and Internet: study protocol for a randomised controlled trial
Bastiaan Boh, Lotte H. J. M. Lemmens, Anita Jansen, Chantal Nederkoorn, Vincent Kerkhofs, Gerasimos Spanakis, Gerhard Weiss, Anne Roefs
Efficacy and safety of carbetocin applied as an intravenous bolus compared to as a short-infusion for caesarean section: study protocol for a randomised controlled trial
Salome Dell-Kuster, Irene Hoesli, Olav Lapaire, Esther Seeberger, Luzius A. Steiner, Heiner C. Bucher, Thierry Girard
Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): study protocol for a randomised controlled trial
Esther L. Wilkinson, Heather A. O’Mahen, Pasco Fearon, Sarah Halligan, Dorothy X. King, Geva Greenfield, Jacqueline Dunkley-Bent, Jennifer Ericksen, Jeannette Milgrom, Paul G. Ramchandani
Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS) for Diabetes
Cheryl P. Lynch, Joni S. Williams, Kenneth J. Ruggiero, Rebecca G. Knapp, Leonard E. Egede
The CORE Service Improvement Programme for mental health crisis resolution teams: study protocol for a cluster-randomised controlled trial
Brynmor Lloyd-Evans, Kate Fullarton, Danielle Lamb, Elaine Johnston, Steve Onyett, David Osborn, Gareth Ambler, Louise Marston, Rachael Hunter, Oliver Mason, Claire Henderson, Nicky Goater, Sarah A. Sullivan, Kathleen Kelly, Richard Gray, Fiona Nolan, Stephen Pilling, Gary Bond, Sonia Johnson
Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial
Marc-Olivier Fischer, Anne-Lise Fiant, Mariam Boutros, Frédéric Flais, Tzetan Filipov, Stéphane Debroczi, Léa Pasqualini, Toufiq Rhanem, Jean-Louis Gérard, Lydia Guittet, Jean-Luc Hanouz, Arnaud Alves, Jean-Jacques Parienti
Comparison of exenatide with biphasic insulin aspart 30 on glucose variability in type 2 diabetes: study protocol for a randomized controlled trial
Shaoyong Xu, Xiangyang Liu, Jie Ming, Qiuhe Ji
Morita therapy for depression and anxiety (Morita Trial): study protocol for a pilot randomised controlled trial
Holly Victoria Rose Sugg, David A. Richards, Julia Frost
Supporting Treatment Adherence Readiness through Training (START) for patients with HIV on antiretroviral therapy: study protocol for a randomized controlled trial
Glenn J. Wagner, Sebastien Linnemayr, Bonnie Ghosh-Dastidar, Judith S. Currier, Risa Hoffman, Stefan Schneider
An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis
David I. Dolling, Monica Desai, Alan McOwan, Richard Gilson, Amanda Clarke, Martin Fisher, Gabriel Schembri, Ann K. Sullivan, Nicola Mackie, Iain Reeves, Mags Portman, John Saunders, Julie Fox, Jake Bayley, Michael Brady, Christine Bowman, Charles J. Lacey, Stephen Taylor, David White, Simone Antonucci, Mitzy Gafos, Sheena McCormack, Owen N. Gill, David T. Dunn, Anthony Nardone
OpenTrials: towards a collaborative open database of all available information on all clinical trials
Ben Goldacre, Jonathan Gray
Dementia and Physical Activity (DAPA) - an exercise intervention to improve cognition in people with mild to moderate dementia: study protocol for a randomized controlled trial
Nicky Atherton, Chris Bridle, Deborah Brown, Helen Collins, Sukhdeep Dosanjh, Frances Griffiths, Susie Hennings, Kamran Khan, Ranjit Lall, Samantha Lyle, Rupert McShane, Dipesh Mistry, Vivien Nichols, Stavros Petrou, Bart Sheehan, Anne-Marie Slowther, Margaret Thorogood, Emma Withers, Peter Zeh, Sarah E. Lamb
Reconstructing communities in cluster trials?
Sapfo Lignou, Sushmita Das, Jigna Mistry, Glyn Alcock, Neena Shah More, David Osrin, Sarah J. L. Edwards
Effects of indexes of consciousness (IoC1 and IoC2) monitoring on remifentanil dosage in modified radical mastectomy: a randomized trial
Guisheng Wu, Lei Zhang, Xuxiang Wang, Ailan Yu, Zongwang Zhang, Jingui Yu
Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals: study protocol for a randomized controlled trial
José Fernando Vilela-Martin, Luiz Tadeu Giollo-Junior, Gaspar Rogério Chiappa, Gerson Cipriano-Junior, Paulo José Cardoso Vieira, Fábio dos Santos Ricardi, Manoel Ildefonso Paz-Landim, Days Oliveira de Andrade, Elizabeth do Espírito Santo Cestário, Luciana Neves Cosenso-Martin, Juan Carlos Yugar-Toledo, José Paulo Cipullo
Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial
Daniela Hesse, Mariana Pinheiro de Araujo, Isabel Cristina Olegário, Nicola Innes, Daniela Prócida Raggio, Clarissa Calil Bonifácio
CAMERA2 – combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: study protocol for a randomised controlled trial
Steven Y. C. Tong, Jane Nelson, David L. Paterson, Vance G. Fowler Jr, Benjamin P. Howden, Allen C. Cheng, Mark Chatfield, Jeffrey Lipman, Sebastian Van Hal, Matthew O’Sullivan, James O. Robinson, Dafna Yahav, David Lye, Joshua S. Davis
Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial
Christina Hunger, Rebecca Hilzinger, Theresa Koch, Johannes Mander, Anja Sander, Hinrich Bents, Jochen Schweitzer
An Internet-based self-help intervention for people with HIV and depressive symptoms: study protocol for a randomized controlled trial
Sanne van Luenen, Vivian Kraaij, Philip Spinhoven, Nadia Garnefski
Effects of a transitional palliative care model on patients with end-stage heart failure: study protocol for a randomized controlled trial
Alina Yee Man Ng, Frances Kam Yuet Wong, Paul Hong Lee
A randomized clinical trial to determine the effectiveness of CO-oximetry and anti-smoking brief advice in a cohort of kidney transplant patients who smoke: study protocol for a randomized controlled trial
Salvador Pita-Fernández, Rocío Seijo-Bestilleiro, Sonia Pértega-Díaz, Ángel Alonso-Hernández, Constantino Fernández-Rivera, Mercedes Cao-López, Teresa Seoane-Pillado, Beatriz López-Calviño, Cristina González-Martín, Francisco Valdés-Cañedo
TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial
Gillian Watson, James O’Hara, Paul Carding, Jan Lecouturier, Deborah Stocken, Tony Fouweather, Janet Wilson
Supervised progressive cross-continuum strength training compared with usual care in older medical patients: study protocol for a randomized controlled trial (the STAND-Cph trial)
Mette Merete Pedersen, Janne Petersen, Nina Beyer, Lars Damkjær, Thomas Bandholm
Engaging adolescents in tuberculosis and clinical trial research through drama
Bey-Marrié Schmidt, Amber Abrams, Michele Tameris
Exploring non-participation in primary care physical activity interventions: PACE-UP trial interview findings
Rebecca Normansell, Rebecca Holmes, Christina Victor, Derek G Cook, Sally Kerry, Steve Iliffe, Michael Ussher, Julia Fox-Rushby, Peter Whincup, Tess Harris
Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial
Rosie Dobson, Robyn Whittaker, Yannan Jiang, Matthew Shepherd, Ralph Maddison, Karen Carter, Richard Cutfield, Catherine McNamara, Manish Khanolkar, Rinki Murphy
Effects of communication training with the MAAS-Global-D instrument on the antibiotic prescribing for respiratory infections in primary care: study protocol of a randomised controlled trial
Friederike Hammersen, Katja Goetz, Andreas Soennichsen, Timo Emcke, Jost Steinhaeuser
Effectiveness of pharmaceutical care for drug treatment adherence in patients with systemic lupus erythematosus in Rio de Janeiro, Brazil: study protocol for a randomized controlled trial
Marise Oliveira-Santos, José Fernando de Souza Verani, Luiz Antônio Bastos Camacho, Carlos Augusto Ferreira de Andrade, Rosele Ferrante-Silva, Evandro Mendes Klumb
Efficacy and safety of intravenous paracetamol in comparison to ibuprofen for the treatment of patent ductus arteriosus in preterm infants: study protocol for a randomized control trial
Carlo Dani, Chiara Poggi, Fabio Mosca, Federico Schena, Gianluca Lista, Luca Ramenghi, Costantino Romagnoli, Enrica Salvatori, Maria Teresa Rosignoli, Paola Lipone, Alessandro Comandini
Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial
Seok-Jae Ko, Kyungmo Park, Jieun Kim, Minji Kim, Joo-Hee Kim, Jeungchan Lee, Abdalla Z. Mohamed, Inkwon Yeo, Jinsung Kim, Sun-Mi Choi, Honggeol Kim, Jae-Woo Park, Jun-Hwan Lee
Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial
Helen J. Moore, Catherine Nixon, Anisah Tariq, Jon Emery, Willie Hamilton, Zoë Hoare, Anne Kershenbaum, Richard D. Neal, Obioha C. Ukoumunne, Juliet Usher-Smith, Fiona M. Walter, Sophie Whyte, Greg Rubin
The clinical and cost effectiveness of a Breathlessness Intervention Service for patients with advanced non-malignant disease and their informal carers: mixed findings of a mixed method randomised controlled trial
Morag C. Farquhar, A. Toby Prevost, Paul McCrone, Barbara Brafman-Price, Allison Bentley, Irene J. Higginson, Chris J. Todd, Sara Booth
Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial
Christina Kruse, Sascha A. Müller, René Warschkow, Cornelia Lüthi, Walter Brunner, Lukas Marti, Michael Christian Sulz, Bruno M. Schmied, Ignazio Tarantino, Ulrich Beutner
When are clinical trials registered? An analysis of prospective versus retrospective registration
Stephanie L. Harriman, Jigisha Patel
The effectiveness of Technology-assisted Cascade Training and Supervision of community health workers in delivering the Thinking Healthy Program for perinatal depression in a post-conflict area of Pakistan – study protocol for a randomized controlled trial
Shamsa Zafar, Siham Sikander, Syed Usman Hamdani, Najia Atif, Parveen Akhtar, Huma Nazir, Joanna Maselko, Atif Rahman
A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain
Robert N. Girandola, Shalini Srivastava, Costas C. Loullis
Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial
David Pickham, Betsy Ballew, Kristi Ebong, Julie Shinn, Mary E. Lough, Barbara Mayer
Sublobar resection versus lobectomy in Surgical Treatment of Elderly Patients with early-stage non-small cell lung cancer (STEPS): study protocol for a randomized controlled trial
Fan Yang, Xizhao Sui, Xiuyuan Chen, Lixue Zhang, Xun Wang, Shaodong Wang, Jun Wang
Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial
Carolina D. Weller, Anna Barker, Ian Darby, Terrence Haines, Martin Underwood, Stephanie Ward, Pat Aldons, Elizabeth Dapiran, Jason J. Madan, Paula Loveland, Sankar Sinha, Mauro Vicaretti, Rory Wolfe, Michael Woodward, John McNeil
E-care 4 caregivers – an online intervention for nonprofessional caregivers of patients with depression: study protocol for a pilot randomized controlled trial
L. Bijker, A. Kleiboer, H. Riper, P. Cuijpers, T. Donker
Intravenous versus epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy (the PAKMAN trial, DRKS 00007784): study protocol for a randomized controlled trial
Rosa Klotz, Stefan Hofer, Alexander Schellhaaß, Colette Dörr-Harim, Solveig Tenckhoff, Thomas Bruckner, Christina Klose, Markus K. Diener, Markus A. Weigand, Markus W. Büchler, Phillip Knebel
Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals
Julia Lawton, Claire Snowdon, Susan Morrow, Jane E. Norman, Fiona C. Denison, Nina Hallowell
Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial
Juan Carlos Montano-Pedroso, Elvio Bueno Garcia, Neil Ferreira Novo, Daniela Francescato Veiga, Lydia Masako Ferreira
Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial
Seungwon Shin, Jiwon Lee, Junghee Yoo, Sung Min Lim, Euiju Lee
Comparing endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) versus fine needle biopsy (FNB) in the diagnosis of solid lesions: study protocol for a randomized controlled trial
Jinlin Wang, Xiaoli Wu, Ping Yin, Qiaozhen Guo, Wei Hou, Yawen Li, Yun Wang, Bin Cheng
Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals
Nicholas S. Downing, Nilay D. Shah, Joseph H. Neiman, Jenerius A. Aminawung, Harlan M. Krumholz, Joseph S. Ross
Acetyl-L-carnitine (ALCAR) to enhance nerve regeneration in carpal tunnel syndrome: study protocol for a randomized, placebo-controlled trial
Matthew W. T. Curran, Jaret Olson, Michael Morhart, Dory Sample, K. Ming Chan
Effectiveness of a clinical guideline to improve dental health among orthodontically treated patients: study protocol for a cluster randomized controlled trial
Barbara C. M. Oosterkamp, Afzal Wafae, Jan G. J. H. Schols, Wil J. M. van der Sanden, Michel Wensing
Improving maternity care using a personal health record: study protocol for a stepped-wedge, randomised, controlled trial
Carola J. M. Groenen, Marjan J. Faber, Jan A. M. Kremer, Frank P. H. A. Vandenbussche, Noortje T. L. van Duijnhoven
“FIND Technology”: investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial
M. L. Bird, J. Cannell, M. L. Callisaya, E. Moles, A. Rathjen, K. Lane, A. Tyson, S. Smith
The effects of improved sanitation on diarrheal prevalence, incidence, and duration in children under five in the SNNPR State, Ethiopia: study protocol for a randomized controlled trial
Sunghoon Jung, Young-Ah Doh, Dawit Belew Bizuneh, Habtamu Beyene, Jieun Seong, Hyunjin Kwon, Yongwhan Kim, Girma Negussie Habteyes, Yigrem Tefera, Seungman Cha
Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial
Mette Krag, Anders Perner, Jørn Wetterslev, Matt P. Wise, Mark Borthwick, Stepani Bendel, Paolo Pelosi, Frederik Keus, Anne Berit Guttormsen, Joerg C. Schefold, Morten Hylander Møller
Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial
Maria Lazo-Porras, Antonio Bernabe-Ortiz, Katherine A. Sacksteder, Robert H. Gilman, German Malaga, David G. Armstrong, J. Jaime Miranda
Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials
Alex Hodkinson, Carrol Gamble, Catrin Tudur Smith
The effects of prolonged wear of textured shoe insoles on gait, foot sensation and proprioception in people with multiple sclerosis: study protocol for a randomised controlled trial
Anna L. Hatton, John Dixon, Keith Rome, Sandra G. Brauer, Katrina Williams, Graham Kerr
The effectiveness of mindfulness-based stress reduction (MBSR) for survivors of breast cancer: study protocol for a randomized controlled trial
Jiayan Huang, Lu Shi
Evaluation of a novel information resource for patients with bronchiectasis: study protocol for a randomised controlled trial
Katy L. M. Hester, Julia Newton, Tim Rapley, Anthony De Soyza
Quantity, topics, methods and findings of randomised controlled trials published by German university departments of general practice – systematic review
Stefan Heinmüller, Antonius Schneider, Klaus Linde
‘The trial is owned by the team, not by an individual’: a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology
Sean Strong, Sangeetha Paramasivan, Nicola Mills, Caroline Wilson, Jenny L. Donovan, Jane M. Blazeby
Dependability of results in conference abstracts of randomized controlled trials in ophthalmology and author financial conflicts of interest as a factor associated with full publication
Ian J. Saldanha, Roberta W. Scherer, Isabel Rodriguez-Barraquer, Henry D. Jampel, Kay Dickersin
Interim pressure garment therapy (4–6 mmHg) and its effect on donor site healing in burn patients: study protocol for a randomised controlled trial
Michelle L. Donovan, Michael J. Muller, Claire Simpson, Michael Rudd, Jennifer Paratz
A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial
Jutta K. H. Skau, Awatef Binti Amer Nordin, Julius C. H. Cheah, Roslinah Ali, Ramli Zainal, Tahir Aris, Zainudin Mohd Ali, Priya Matzen, Regien Biesma, Jens Aagaard-Hansen, Mark A. Hanson, Shane A. Norris
Pipelle for Pregnancy (PIP): study protocols for three randomised controlled trials
Sarah Lensen, Wellington Martins, Carolina Nastri, Lynn Sadler, Cindy Farquhar
Erratum to: CASPER plus (CollAborative care in screen-positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial
Karen Overend, Helen Lewis, Della Bailey, Kate Bosanquet, Carolyn Chew-Graham, David Ekers, Samantha Gascoyne, Deborah Hems, John Holmes, Ada Keding, Dean McMillan, Shaista Meer, Jodi Meredith, Natasha Mitchell, Sarah Nutbrown, Steve Parrott, David Richards, Gemma Traviss, Dominic Trépel, Rebecca Woodhouse, Simon Gilbody
A high-selenium lentil dietary intervention in Bangladesh to counteract arsenic toxicity: study protocol for a randomized controlled trial
Regina M. Krohn, Rubhana Raqib, Evana Akhtar, Albert Vandenberg, Judit E. G. Smits
A qualitative exploration of trial-related terminology in a study involving Deaf British Sign Language users
Alys Young, Rosemary Oram, Claire Dodds, Catherine Nassimi-Green, Rachel Belk, Katherine Rogers, Linda Davies, Karina Lovell
Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial
Christopher Williams, Carrie-Anne McClay, Rebeca Martinez, Jill Morrison, Caroline Haig, Ray Jones, Paul Farrand
Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials
Eva O. Melin, Ralph Svensson, Sven-Åke Gustavsson, Agneta Winberg, Ewa Denward-Olah, Mona Landin-Olsson, Hans O. Thulesius
Modelling variable dropout in randomised controlled trials with longitudinal outcomes: application to the MAGNETIC study
Ruwanthi Kolamunnage-Dona, Colin Powell, Paula Ruth Williamson
Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial
Stephen J. Chester, Kellie Stockton, Alexandra De Young, Belinda Kipping, Zephanie Tyack, Bronwyn Griffin, Ralph L. Chester, Roy M. Kimble
Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial
Robert B. Saper, Chelsey M. Lemaster, A. Rani Elwy, Ruth Paris, Patricia M. Herman, Dorothy N. Plumb, Karen J. Sherman, Erik J. Groessl, Susan Lynch, Shihwe Wang, Janice Weinberg
Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial
Nicolas Javaud, Olivier Fain, Isabelle Durand-Zaleski, David Launay, Laurence Bouillet, Anne Gompel, Alain Sobel, Maguy Woimant, Hasina Rabetrano, Tomislav Petrovic, Frédéric Lapostolle, Isabelle Boccon-Gibod, Paul-Georges Reuter, Philippe Bertrand, Brigitte Coppere, Bernard Floccard, Gisele Kanny, Ludovic Martin, Eric Vicaut, Frédéric Adnet
The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA®, in a community pharmacy setting: study protocol for a randomised controlled trial
Susan Mary O’Dwyer, Elaine MacHale, Imran Sulaiman, Martin Holmes, Cian Hughes, Shona D’Arcy, Viliam Rapcan, Terence Taylor, Fiona Boland, Sinthia Bosnic-Anticevich, Richard B. Reilly, Sheila A. Ryder, Richard W. Costello
Sharing raw data from clinical trials: what progress since we first asked “Whose data set is it anyway?”
Andrew J. Vickers
Time-differentiated target temperature management after out-of-hospital cardiac arrest: a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial
Hans Kirkegaard, Bodil S Rasmussen, Inge de Haas, Jørgen Feldbæk Nielsen, Susanne Ilkjær, Anne Kaltoft, Anni Nørregaard Jeppesen, Anders Grejs, Christophe Henri Valdemar Duez, Alf Inge Larsen, Ville Pettilä, Valdo Toome, Urmet Arus, Fabio Silvio Taccone, Christian Storm, Markus B. Skrifvars, Eldar Søreide
Figure-of-eight bandage versus arm sling for treating middle-third clavicle fractures in adults: study protocol for a randomised controlled trial
Mario Lenza, Luiz Fabiano Presente Taniguchi, Mario Ferretti
The use of qualitative methods to inform Delphi surveys in core outcome set development
T. Keeley, P. Williamson, P. Callery, L. L. Jones, J. Mathers, J. Jones, B. Young, M. Calvert
Effectiveness of the blended care self-management program “Partner in Balance” for early-stage dementia caregivers: study protocol for a randomized controlled trial
Lizzy M. M. Boots, Marjolein E. de Vugt, Gertrudis I. J. M. Kempen, Frans R. J. Verhey
Ethnographic methods for process evaluations of complex health behaviour interventions
Sarah Morgan-Trimmer, Fiona Wood
Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial
Francesco Sofi, Monica Dinu, Giuditta Pagliai, Francesca Cesari, Rossella Marcucci, Alessandro Casini
Sample size calculations for stepped wedge trials using design effects are only approximate in some circumstances
Karla Hemming
Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial
Christian Iorio-Morin, Jocelyn Blanchard, Maxime Richer, David Mathieu
Activities and participation of children and adolescents after mild traumatic brain injury and the effectiveness of an early intervention (Brains Ahead!): study protocol for a cohort study with a nested randomised controlled trial
M. Irene Renaud, Suzanne A. M. Lambregts, Arend J. de Kloet, Coriene E. Catsman-Berrevoets, Ingrid G. L. van de Port, Caroline M. van Heugten
The feasibility and acceptability of a preventive intervention programme for children with depressed parents: study protocol for a randomised controlled trial
Valeria de Angel, Fernanda Prieto, Tracy R. G. Gladstone, William R. Beardslee, Matías Irarrázaval
Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial
Katharine O’Hearn, Dayre McNally, Karen Choong, Anand Acharya, Hector R. Wong, Margaret Lawson, Tim Ramsay, Lauralyn McIntyre, Elaine Gilfoyle, Marisa Tucci, David Wensley, Ronald Gottesman, Gavin Morrison, Kusum Menon
Clinical performance during 48 months of two current glass ionomer restorative systems with coatings: a randomized clinical trial in the field
Thomas Klinke, Amro Daboul, Anita Turek, Roland Frankenberger, Reinhard Hickel, Reiner Biffar
Stopping guidelines for an effectiveness trial: what should the protocol specify?
Jon E. Tyson, Claudia Pedroza, Dennis Wallace, Carl D’Angio, Edward F. Bell, Abhik Das
Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial
Narayan Karunanithy, Irene Rebollo Mesa, Anthony Dorling, Francis Calder, Konstantinos Katsanos, Vikki Semik, Emily Robinson, Janet Peacock, Neelanjan Das, Colin Forman, Sarah Lawman, Kate Steiner, C Jason Wilkins, Michael G Robson
A case study of SMART attributes: a qualitative assessment of generalizability, retention rate, and trial quality
Erica E. M. Moodie, James C. Karran, Susan M. Shortreed
Efficacy of transcranial direct-current stimulation (tDCS) in women with provoked vestibulodynia: study protocol for a randomized controlled trial
Annie Morin, Guillaume Léonard, Véronique Gougeon, Guy Waddell, Yves-André Bureau, Isabelle Girard, Mélanie Morin
Process-based approach to modeling recurrent-event data explicated on the basis of occurrences of tooth losses in two different prosthetic treatment concepts
Hans H. Diebner, Birgit Marré, Ingo Roeder, Michael H. Walter
Epidermal grafting versus split-thickness skin grafting for wound healing (EPIGRAAFT): study protocol for a randomised controlled trial
Muholan Kanapathy, Nadine Hachach-Haram, Nicola Bystrzonowski, Keith Harding, Afshin Mosahebi, Toby Richards
Electroacupuncture to treat gastroesophageal reflux disease: study protocol for a randomized controlled trial
Gajin Han, Jungtae Leem, Hojung Lee, Junhee Lee
Perfusion Pressure Cerebral Infarct (PPCI) trial - the importance of mean arterial pressure during cardiopulmonary bypass to prevent cerebral complications after cardiac surgery: study protocol for a randomised controlled trial
Anne G. Vedel, Frederik Holmgaard, Lars Simon Rasmussen, Olaf B. Paulson, Carsten Thomsen, Else Rubæk Danielsen, Annika Langkilde, Jens P. Goetze, Theis Lange, Hanne Berg Ravn, Jens C. Nilsson
Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial
Wai Kun, Linda L. D. Zhong, Liang Dai, Chung-Wah Cheng, Ai-Ping Lu, Zhao-Xiang Bian
The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial
Haleema Shakur, Ian Roberts, Philip Edwards, Diana Elbourne, Zarko Alfirevic, Carine Ronsmans
Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial
Benoit Trojak, Agnès Soudry-Faure, Nicolas Abello, Maud Carpentier, Lysiane Jonval, Coralie Allard, Foroogh Sabsevari, Emilie Blaise, Eddy Ponavoy, Bernard Bonin, Vincent Meille, Jean-Christophe Chauvet-Gelinier
The evaluation of three treatments for plantar callus: a three-armed randomised, comparative trial using biophysical outcome measures
Farina Hashmi, Christopher J. Nester, Ciaran R.F. Wright, Sharon Lam
Erratum to: ‘“FIND Technology”: investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial’
M. L. Bird, J. Cannell, M. L. Callisaya, E. Moles, A. Rathjen, K. Lane, A. Tyson, S. Smith
Erratum to: ‘Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial’
Francesco Sofi, Monica Dinu, Giuditta Pagliai, Francesca Cesari, Rossella Marcucci, Alessandro Casini
Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study
Alvaro Sánchez, Carmen Silvestre, Natalia Campo, Gonzalo Grandes
Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial
Christophe Rignon-Bret, Alain Hadida, Alexis Aidan, Thien-Huong Nguyen, Gerard Pasquet, Helene Fron-Chabouis, Claudine Wulfman
Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial
Jiao Chen, Shuwei Feng, Jiuzhi Zeng, Xi Wu, Mingxiao Yang, Hongzhi Tang, Huaying Fan, Jie Yang, Fanrong Liang
Digital Cognitive Behavioural Therapy for Insomnia versus sleep hygiene education: the impact of improved sleep on functional health, quality of life and psychological well-being. Study protocol for a randomised controlled trial
Colin A. Espie, Annemarie I. Luik, John Cape, Christopher L. Drake, A. Niroshan Siriwardena, Jason C. Ong, Christopher Gordon, Sophie Bostock, Peter Hames, Mhairi Nisbet, Bryony Sheaves, Russell G Foster, Daniel Freeman, Joan Costa-Font, Richard Emsley, Simon D. Kyle
Efficacy and mechanisms of behavioral therapy components for insomnia coexisting with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial
Mary C. Kapella, James J. Herdegen, Franco Laghi, Alana D. Steffen, David W. Carley
Chinese herbal medicine Tangshen Formula treatment of patients with type 2 diabetic kidney disease with macroalbuminuria: study protocol for a randomized controlled trial
Meihua Yan, Yumin Wen, Liping Yang, Xi’ai Wu, Xiaoguang Lu, Bingxuan Zhang, Weiping Huang, Ping Li
Erratum to: ‘Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (The ELAIN-Trial): study protocol for a randomized controlled trial’
Alexander Zarbock, Joachim Gerß, Hugo Van Aken, Andreea Boanta, John A. Kellum, Melanie Meersch
Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial
Suzanne Schuh, Judy Sweeney, Stephen B. Freedman, Allan L. Coates, David W. Johnson, Graham Thompson, Jocelyn Gravel, Francine M. Ducharme, Roger Zemek, Amy C. Plint, Darcy Beer, Terry Klassen, Sarah Curtis, Karen Black, Darcy Nicksy, Andrew R. Willan
Danish study of Non-Invasive testing in Coronary Artery Disease (Dan-NICAD): study protocol for a randomised controlled trial
Louise Nissen, Simon Winther, Christin Isaksen, June Anita Ejlersen, Lau Brix, Grazina Urbonaviciene, Lars Frost, Lene Helleskov Madsen, Lars Lyhne Knudsen, Samuel Emil Schmidt, Niels Ramsing Holm, Michael Maeng, Mette Nyegaard, Hans Erik Bøtker, Morten Bøttcher
A review of approaches to improve participation of culturally and linguistically diverse populations in clinical trials
Jo-anne Hughson, Robyn Woodward-Kron, Anna Parker, John Hajek, Agnese Bresin, Ute Knoch, Tuong Phan, David Story
Building a recruitment database for asthma trials: a conceptual framework for the creation of the UK Database of Asthma Research Volunteers
Bright I. Nwaru, Ireneous N. Soyiri, Colin R. Simpson, Chris Griffiths, Aziz Sheikh
Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial
Daniele Trevisanuto, Giovanni Putoto, Damiano Pizzol, Tiziana Serena, Fabio Manenti, Silvia Varano, Eleonora Urso, William Massavon, Ademe Tsegaye, Oliver Wingi, Emanuel Onapa, Giulia Segafredo, Francesco Cavallin
Assessment of learning curves in complex surgical interventions: a consecutive case-series study
Olympia Papachristofi, David Jenkins, Linda D. Sharples
The role of therapeutic optimism in recruitment to a clinical trial in a peripartum setting: balancing hope and uncertainty
Nina Hallowell, Claire Snowdon, Susan Morrow, Jane E. Norman, Fiona C. Denison, Julia Lawton
Exercise prior to assisted fertilization in overweight and obese women (FertilEX): study protocol for a randomized controlled trial
Kari Margrethe Lundgren, Liv Bente Romundstad, Vidar von Düring, Siv Mørkved, Sigrun Kjøtrød, Trine Moholdt
Non-sedation versus sedation with a daily wake-up trial in critically ill patients recieving mechanical ventilation - effects on long-term cognitive function: Study protocol for a randomized controlled trial, a substudy of the NONSEDA trial
Helene Korvenius Nedergaard, Hanne Irene Jensen, Mette Stylsvig, Jørgen T. Lauridsen, Palle Toft
Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults
Deborah A. Hall, Haula Haider, Agnieszka J. Szczepek, Pia Lau, Sarah Rabau, Julie Jones-Diette, Alain Londero, Niklas K. Edvall, Christopher R. Cederroth, Marzena Mielczarek, Thomas Fuller, Angel Batuecas-Caletrio, Petra Brueggemen, Dean M. Thompson, Arnaud Norena, Rilana F. F. Cima, Rajnikant L. Mehta, Birgit Mazurek
BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial
Ary I. Savitri, Nikmah S. Idris, Wahyuni Indawati, Siti Rizny F. Saldi, Dwirani Amelia, Mohammad Baharuddin, Sudigdo Sastroasmoro, Diederick E. Grobbee, Cuno S. P. M. Uiterwaal
A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes
Fowzia Ibrahim, Brian D. M. Tom, David L. Scott, Andrew Toby Prevost
Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial
Ana Howarth, Linda Perkins-Porras, Jared G. Smith, Jeevakan Subramaniam, Claire Copland, Mike Hurley, Iain Beith, Muhammad Riaz, Michael Ussher
Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial
Mirrian Hilbink, Joyca Lacroix, Linda Bremer - van der Heiden, Aart van Halteren, Martina Teichert, Jan van Lieshout
The RooPfs study to assess whether improved housing provides additional protection against clinical malaria over current best practice in The Gambia: study protocol for a randomized controlled study and ancillary studies
Margaret Pinder, Lesong Conteh, David Jeffries, Caroline Jones, Jakob Knudsen, Balla Kandeh, Musa Jawara, Elisa Sicuri, Umberto D’Alessandro, Steve W. Lindsay
Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study): Study protocol for a randomised controlled trial
Catherine Brennand, Alexander von Wilamowitz-Moellendorff, Sarah Dunn, Jennifer Wilkinson, Thomas Chadwick, Laura Ternent, Yemi Oluboyede, Ruth Wood, Katherine Walton, Mandy Fader, James N’Dow, Mohamed Abdel-Fattah, Doreen McClurg, Paul Little, Paul Hilton, Anthony Timoney, Nicola Morris, Nikesh Thiruchelvam, James Larcombe, Simon Harrison, Heather Armstrong, Elaine McColl, Robert Pickard
Shared care management of patients with type 2 diabetes across the primary and secondary healthcare sectors: study protocol for a randomised controlled trial
Lene Munch, Birgitte Bennich, Anne B. Arreskov, Dorthe Overgaard, Hanne Konradsen, Filip K. Knop, Tina Vilsbøll, Michael E. Røder
Design of trials for interrupting the transmission of endemic pathogens
Mariabeth Silkey, Tobias Homan, Nicolas Maire, Alexandra Hiscox, Richard Mukabana, Willem Takken, Thomas A. Smith
The impact of albendazole treatment on the incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam: study protocol for a randomized controlled trial
Jacqueline M. Leung, Chau Tran Thi Hong, Nghia Ho Dang Trung, Hoa Nhu Thi, Chau Nguyen Ngoc Minh, Thuy Vu Thi, Dinh Thanh Hong, Dinh Nguyen Huy Man, Sarah C. L. Knowles, Marcel Wolbers, Nhat Le Thanh Hoang, Guy Thwaites, Andrea L. Graham, Stephen Baker
Efficacy and safety of auricular point acupressure treatment for gastrointestinal dysfunction after laparoscopic cholecystectomy: study protocol for a randomized controlled trial
Yuhua Tan, Ye Zhao, Tian He, Yueshen Ma, Wang Cai, Yandong Wang
The efficacy and safety of Fufangdanshen tablets (Radix Salviae miltiorrhizae formula tablets) for mild to moderate vascular dementia: a study protocol for a randomized controlled trial
Jinzhou Tian, Jing Shi, Mingqing Wei, Renan Qin, Jingnian Ni, Xuekai Zhang, Ting Li, Yongyan Wang
Recruitment of young adults for weight gain prevention: randomized comparison of direct mail strategies
Melissa M. Crane, Jessica Gokee LaRose, Mark A. Espeland, Rena R. Wing, Deborah F. Tate
Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI)
Jenny L. Donovan, Leila Rooshenas, Marcus Jepson, Daisy Elliott, Julia Wade, Kerry Avery, Nicola Mills, Caroline Wilson, Sangeetha Paramasivan, Jane M. Blazeby
The influence of a home-based exercise intervention on human health indices in individuals with chronic spinal cord injury (HOMEX-SCI): study protocol for a randomised controlled trial
Tom E. Nightingale, Jean-Philippe Walhin, James E. Turner, Dylan Thompson, James L. J. Bilzon
Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial
Chetna Malhotra, David Kheng Leng Sim, Fazlur Jaufeerally, Nivedita Nadkarni Vikas, Genevieve Wong Cheng Sim, Boon Cheng Tan, Clarice Shu Hwa Ng, Pei Leng Tho, Jingfen Lim, Claire Ya-Ting Chuang, Florence Hui Mei Fong, Joy Liu, Eric A. Finkelstein
Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND)
Theingi Aung, Richard Haynes, Jill Barton, Jolyon Cox, Aleksandra Murawska, Kevin Murphy, Michael Lay, Jane Armitage, Louise Bowman
Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial
Jan Becker, Manfred E. Beutel, Katharina Gerzymisch, Dirk Schulz, Martin Siepmann, Rudolf J. Knickenberg, Stefan Schmädeke, Peter Ferdinand, Rüdiger Zwerenz
The effect of fines on nonattendance in public hospital outpatient clinics: study protocol for a randomized controlled trial
Emely Ek Blæhr, Thomas Kristensen, Ulla Væggemose, Rikke Søgaard
Effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement for osteoarthritis: study protocol for a randomised controlled trial
Vikki Wylde, Neil Artz, Elsa Marques, Erik Lenguerrand, Samantha Dixon, Andrew D. Beswick, Amanda Burston, James Murray, Tarique Parwez, Ashley W. Blom, Rachael Gooberman-Hill
An organisational change intervention for increasing the delivery of smoking cessation support in addiction treatment centres: study protocol for a randomized controlled trial
Billie Bonevski, Ashleigh Guillaumier, Anthony Shakeshaft, Michael Farrell, Flora Tzelepis, Scott Walsberger, Catherine D’Este, Chris Paul, Adrian Dunlop, Andrew Searles, Peter Kelly, Rae Fry, Robert Stirling, Carrie Fowlie, Eliza Skelton
Efficacy and safety of Yirui capsule in patients with hyperlipidemia: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial
Liang Dai, Linda L. D. Zhong, Yan Cao, Wei Chen, Ying Cheng, Xiu-Fang Lin, Zhao-Xiang Bian, Ai-Ping Lu
Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial
Dinesh Neupane, Craig S. McLachlan, Bo Christensen, Arjun Karki, Henry B. Perry, Per Kallestrup
A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA1- or BRCA2-mutated HER2-negative advanced breast cancer as first line treatment (REVIVAL): study protocol for a randomized controlled trial
Philip C. Schouten, Gwen M. H. E. Dackus, Serena Marchetti, Harm van Tinteren, Gabe S. Sonke, Jan H. M. Schellens, Sabine C. Linn
Identifying the participant characteristics that predict recruitment and retention of participants to randomised controlled trials involving children: a systematic review
Louise Robinson, Pauline Adair, Margaret Coffey, Rebecca Harris, Girvan Burnside
Vitamin D and omega-3 fatty acid supplements in children with autism spectrum disorder: a study protocol for a factorial randomised, double-blind, placebo-controlled trial
Hajar Mazahery, Cathryn Conlon, Kathryn L. Beck, Marlena C. Kruger, Welma Stonehouse, Carlos A. Camargo Jr., Barbara J. Meyer, Bobby Tsang, Owen Mugridge, Pamela R. von Hurst
The efficacy of resveratrol in controlling hypertension: study protocol for a randomized, crossover, double-blinded, placebo-controlled trial
Ali Movahed, Afshin Ostovar, Daryoush Iranpour, Sijo Joseph Thandapilly, Pema Raj, Xavier Lieben Louis, James Michael Smoliga, Thomas Netticadan
Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial
Howard Ring, Nakita Gilbert, Roxanne Hook, Adam Platt, Christopher Smith, Fiona Irvine, Cam Donaldson, Elizabeth Jones, Joanna Kelly, Adrian Mander, Caroline Murphy, Mark Pennington, Angela Pullen, Marcus Redley, Simon Rowe, James Wason
High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): study protocol for a randomised controlled trial
Robinson Ramírez-Vélez, Alejandra Hernandez, Karem Castro, Alejandra Tordecilla-Sanders, Katherine González-Ruíz, Jorge Enrique Correa-Bautista, Mikel Izquierdo, Antonio García-Hermoso
Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial
Laura Asher, Mary De Silva, Charlotte Hanlon, Helen A. Weiss, Rahel Birhane, Dawit A. Ejigu, Girmay Medhin, Vikram Patel, Abebaw Fekadu
Evaluating the effectiveness and cost-effectiveness of Dementia Care Mapping™ to enable person-centred care for people with dementia and their carers (DCM-EPIC) in care homes: study protocol for a randomised controlled trial
Claire A. Surr, Rebecca E. A. Walwyn, Amanda Lilley-Kelly, Robert Cicero, David Meads, Clive Ballard, Kayleigh Burton, Lynn Chenoweth, Anne Corbett, Byron Creese, Murna Downs, Amanda J. Farrin, Jane Fossey, Lucy Garrod, Elizabeth H. Graham, Alys Griffiths, Ivana Holloway, Sharon Jones, Baber Malik, Najma Siddiqi, Louise Robinson, Graham Stokes, Daphne Wallace
Update on the endorsement of CONSORT by high impact factor journals: a survey of journal “Instructions to Authors” in 2014
Larissa Shamseer, Sally Hopewell, Douglas G. Altman, David Moher, Kenneth F. Schulz
Study design and rationale of the ‘Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial’: study protocol for a randomized controlled trial
Woong Gil Choi, Seung Woon Rha, Cheol Ung Choi, Eung Ju Kim, Dong Joo Oh, Yoon Hyung Cho, Sang Ho Park, Seung Jin Lee, Ae Yong Hur, Young Guk Ko, Sang Min Park, Ki Chang Kim, Joo Han Kim, Min Woong Kim, Sang Min Kim, Jang Ho Bae, Jung Min Bong, Won Yu Kang, Jae Bin Seo, Woo Yong Jung, Jang Hyun Cho, Do Hoi Kim, Ji Hoon Ahn, Soo Hyun Kim, Ji Yong Jang
Effectiveness and cost-effectiveness of a very brief physical activity intervention delivered in NHS Health Checks (VBI Trial): study protocol for a randomised controlled trial
Joanna Mitchell, Wendy Hardeman, Sally Pears, Joana C. Vasconcelos, A. Toby Prevost, Ed Wilson, Stephen Sutton
GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest: study protocol for a randomized controlled trial
Sebastian Wiberg, Christian Hassager, Jakob Hartvig Thomsen, Martin Frydland, Dan Eik Høfsten, Thomas Engstrøm, Lars Køber, Henrik Schmidt, Jacob Eifer Møller, Jesper Kjaergaard
Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial
Yuxiu Sun, Hong Zhao, Yongming Ye, Wenbin Nie, Wenjing Bai, Jia Liu, Sinuo Li, Fang Wang, Mingjuan Han, Liyun He
Efficacy, safety, and tolerability of lacosamide in patients with gain-of-function Nav1.7 mutation-related small fiber neuropathy: study protocol of a randomized controlled trial–the LENSS study
Bianca T. A. de Greef, Ingemar S. J. Merkies, Margot Geerts, Catharina G. Faber, Janneke G. J. Hoeijmakers
What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges
Anne Daykin, Lucy E. Selman, Helen Cramer, Sharon McCann, Gillian W. Shorter, Matthew R. Sydes, Carrol Gamble, Rhiannon Macefield, J. Athene Lane, Alison Shaw
Rationale and design of the Baptist Employee Healthy Heart Study: a randomized trial assessing the efficacy of the addition of an interactive, personalized, web-based, lifestyle intervention tool to an existing health information web platform in a high-risk employee population
Janisse M. Post, Shozab S. Ali, Lara L. Roberson, Ehimen C. Aneni, Sameer Shaharyar, Adnan Younus, Omar Jamal, Rameez Ahmad, Muhammad A. Aziz, Rehan Malik, Erica S. Spatz, Theodore Feldman, Jonathan Fialkow, Emir Veledar, Ricardo C. Cury, Arthur S. Agatston, Khurram Nasir
Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes
Daniel J. Bratton, Mahesh K. B. Parmar, Patrick P. J. Phillips, Babak Choodari-Oskooei
A phase II trial comparing pazopanib with doxorubicin as first-line treatment in elderly patients with metastatic or advanced soft tissue sarcoma (EPAZ): study protocol for a randomized controlled trial
Annika Karch, Armin Koch, Viktor Grünwald
Can “realist” randomised controlled trials be genuinely realist?
Sara Van Belle, Geoff Wong, Gill Westhorp, Mark Pearson, Nick Emmel, Ana Manzano, Bruno Marchal
Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial
Emma Beck, Sune Bo, Matthias Gondan, Stig Poulsen, Liselotte Pedersen, Jesper Pedersen, Erik Simonsen
Comparison of coronary computed tomography angiography image quality with high- and low-concentration contrast agents (CONCENTRATE): study protocol for a randomized controlled trial
Dong Jin Im, Yun-Hyeon Kim, Ki Seok Choo, Joon-Won Kang, Jung Im Jung, Yoodong Won, Hyo Rim Kim, Myung Hee Chung, Kyunghwa Han, Byoung Wook Choi
Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing
Marcel Bilger, Tina T. Wong, Kaye L. Howard, Jia Yi Lee, Ai Nee Toh, Geraldine John, Ecosse L. Lamoureux, Eric A. Finkelstein
Prevention of the development of psychological distress following a motor vehicle crash: study protocol for a randomized controlled trial
Rebecca Guest, Yvonne Tran, Bamini Gopinath, Ian D. Cameron, Ashley Craig
Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2): study protocol for a randomised controlled trial
Thomas P. Hellyer, Niall H. Anderson, Jennie Parker, Paul Dark, Tina Van Den Broeck, Suveer Singh, Ronan McMullan, Ashley M. Agus, Lydia M. Emerson, Bronagh Blackwood, Savita Gossain, Tim S. Walsh, Gavin D. Perkins, Andrew Conway Morris, Daniel F. McAuley, A. John Simpson
Comparative effects of Yi Jin Jing versus Tai Chi exercise training on benign prostatic hyperplasia-related outcomes in older adults: study protocol for a randomized controlled trial
XiangYun Liu, Guoyuan Huang, Peijie Chen, Yong Li, JiuLin Xiang, Ting Chen, Ru Wang
No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals
Nicole B. Gabler, Naihua Duan, Eli Raneses, Leah Suttner, Michael Ciarametaro, Elizabeth Cooney, Robert W. Dubois, Scott D. Halpern, Richard L. Kravitz
Biases affecting injected doses of an experimental drug during clinical trials
Nancy Perrottet, Françoise Brunner-Ferber, Eric Grouzmann, François Spertini, Jérôme Biollaz, Thierry Buclin, Nicolas Widmer
TSCQ study: a randomized, controlled, open-label trial of daily trimethoprim-sulfamethoxazole or weekly chloroquine among adults on antiretroviral therapy in Malawi: study protocol for a randomized controlled trial
Matthew B. Laurens, Randy G. Mungwira, Osward M. Nyirenda, Titus H. Divala, Maxwell Kanjala, Francis Muwalo, Felix A. Mkandawire, Lufina Tsirizani, Wongani Nyangulu, Edson Mwinjiwa, Terrie E. Taylor, Jane Mallewa, William C. Blackwelder, Christopher V. Plowe, Miriam K. Laufer, Joep J. van Oosterhout
Evaluation of differential effects of metformin treatment in obese children according to pubertal stage and genetic variations: study protocol for a randomized controlled trial
Belén Pastor-Villaescusa, Javier Caballero-Villarraso, M. Dolores Cañete, Raúl Hoyos, José Maldonado, Gloria Bueno, Rosaura Leis, Ángel Gil, Ramón Cañete, Concepción M. Aguilera
A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): study protocol
Caroline Greenan, Lynn Murphy, Ly-Mee Yu, Patrick G. Kehoe, Elizabeth Coulthard, Philip Bath, Robert Stewart, Rob Jones, Anne Corbett, Alan Thomas, Peter Connelly, Frank Arrojo, Rachel Canning, Sylvia Wallach, Catherine Henderson, Bernadette McGuinness, Mike O’Sullivan, Clive Holmes, Martin Knapp, Clive Ballard, Peter Passmore, Peter Passmore, Eric Jackson, Roy Soiza, Peter Connelly, Rob G. Jones, Vanessa Raymont, Latha Velayudhan, Alan Thomas, Rohan Vanderputt, Stephen Pearson, Robert Lawrence, Clive Ballard, Frances Harrington
Expectations, effect and experiences of an easily accessible self-management intervention for people with chronic pain: study protocol for a randomised controlled trial with embedded qualitative study
Torunn Hatlen Nøst, Aslak Steinsbekk, Ola Bratås, Kjersti Grønning
Concurrent transcranial direct current stimulation and progressive resistance training in Parkinson’s disease: study protocol for a randomised controlled trial
Ashlee M. Hendy, Alex Tillman, Timo Rantalainen, Makii Muthalib, Liam Johnson, Dawson J. Kidgell, Daniel Wundersitz, Peter G. Enticott, Wei-Peng Teo
Pilot Randomized trial of Fibrinogen in Trauma Haemorrhage (PRooF-iTH): study protocol for a randomized controlled trial
Jacob Steinmetz, Hanne Hee Henriksen, Anne Marie Sørensen, Theis Lange, Claus Falck Larsen, Pär I. Johansson, Jakob Stensballe
A parenting programme to prevent abuse of adolescents in South Africa: study protocol for a randomised controlled trial
Lucie Cluver, Franziska Meinck, Yulia Shenderovich, Catherine L. Ward, Rocio Herrero Romero, Alice Redfern, Carl Lombard, Jenny Doubt, Janina Steinert, Ricardo Catanho, Camille Wittesaele, Sachin De Stone, Nasteha Salah, Phelisa Mpimpilashe, Jamie Lachman, Heidi Loening, Frances Gardner, Daphnee Blanc, Mzuvekile Nocuza, Meryn Lechowicz
“I didn’t really understand it, I just thought it’d help”: exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non-placebo clinical IMP trial
Emily Harrop, Simon Noble, Michelle Edwards, Stephanie Sivell, Barbara Moore, Annmarie Nelson
Intravenous immunoglobulin therapy for small fiber neuropathy: study protocol for a randomized controlled trial
Bianca T. A. de Greef, Margot Geerts, Janneke G. J. Hoeijmakers, Catharina G. Faber, Ingemar S. J. Merkies
Improving treatment and liver fibrosis outcomes with metformin in HCV-HIV co-infected and HCV mono-infected patients with insulin resistance: study protocol for a randomized controlled trial
Mary-Anne Doyle, Joel Singer, Terry Lee, Miriam Muir, Curtis Cooper
Erratum to: ‘Effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial spasm compared to standard care: study protocol for a randomised controlled trial’
Sadie Wickwar, Hayley McBain, Stanton P. Newman, Shashivadan P. Hirani, Catherine Hurt, Nicola Dunlop, Chris Flood, Daniel G. Ezra
The beneficial effects of cognitive training with simple calculation and reading aloud in an elderly postsurgical population: study protocol for a randomized controlled trial
Kay Kulason, Rui Nouchi, Yasushi Hoshikawa, Masafumi Noda, Yoshinori Okada, Ryuta Kawashima
Advantages of Bayesian monitoring methods in deciding whether and when to stop a clinical trial: an example of a neonatal cooling trial
Claudia Pedroza, Jon E. Tyson, Abhik Das, Abbot Laptook, Edward F. Bell, Seetha Shankaran
Bayesian accrual prediction for interim review of clinical studies: open source R package and smartphone application
Yu Jiang, Peter Guarino, Shuangge Ma, Steve Simon, Matthew S. Mayo, Rama Raghavan, Byron J. Gajewski
Kunxian capsules in the treatment of patients with ankylosing spondylitis: a randomized placebo-controlled clinical trial
Qiuxia Li, Li Li, Liqi Bi, Changhong Xiao, Zhiming Lin, Shuangyan Cao, Zetao Liao, Jieruo Gu
Valaciclovir to prevent Cytomegalovirus mediated adverse modulation of the immune system in ANCA-associated vasculitis (CANVAS): study protocol for a randomised controlled trial
Dimitrios Chanouzas, Lovesh Dyall, Peter Nightingale, Charles Ferro, Paul Moss, Matthew David Morgan, Lorraine Harper
Adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): study protocol for a phase III, multi-centre, double-masked randomised controlled trial
Philip J. Banerjee, Victoria R. Cornelius, Rachel Phillips, Jessica W. Lo, Catey Bunce, Joanna Kelly, Caroline Murphy, Rhiannon Tudor Edwards, Elizabeth L. Robertson, David G. Charteris
Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial
Smita Awasthi, Reason Wilken, Forum Patel, J. Bruce German, David A. Mills, Carlito B. Lebrilla, Kyoungmi Kim, Samara L. Freeman, Jennifer T. Smilowitz, April W. Armstrong, Emanual Maverakis
Is using multiple imputation better than complete case analysis for estimating a prevalence (risk) difference in randomized controlled trials when binary outcome observations are missing?
Mavuto Mukaka, Sarah A. White, Dianne J. Terlouw, Victor Mwapasa, Linda Kalilani-Phiri, E. Brian Faragher
Evaluating the efficacy of dexamethasone in the treatment of patients with persistent acute respiratory distress syndrome: study protocol for a randomized controlled trial
Jesús Villar, Javier Belda, José Manuel Añón, Jesús Blanco, Lina Pérez-Méndez, Carlos Ferrando, Domingo Martínez, Juan Alfonso Soler, Alfonso Ambrós, Tomás Muñoz, Rosana Rivas, Ruth Corpas, Francisco J. Díaz-Dominguez, Marina Soro, Miguel Angel García-Bello, Rosa Lidia Fernández, Robert M. Kacmarek
Service-integration approaches for families with low income: a Families First Edmonton, community-based, randomized, controlled trial
Jane Drummond, Natasha Wiebe, Sylvia So, Laurie Schnirner, Jeffrey Bisanz, Deanna L. Williamson, Maria Mayan, Laura Templeton, Konrad Fassbender
Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals
Angus G. K. McNair, Sara T. Brookes, Robert N. Whistance, Rachael O. Forsythe, Rhiannon Macefield, Jonathan Rees, James Jones, George Smith, Anne M. Pullyblank, Kerry N. L. Avery, Michael G. Thomas, Paul A. Sylvester, Anne Russell, Alfred Oliver, Dion Morton, Robin Kennedy, David G. Jayne, Richard Huxtable, Rowland Hackett, Susan J. Dutton, Mark G. Coleman, Mia Card, Julia Brown, Jane M. Blazeby
Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial
Ivo N. van Schaik, Nan van Geloven, Vera Bril, Hans-Peter Hartung, Richard A. Lewis, Gen Sobue, John-Philip Lawo, Orell Mielke, David R. Cornblath, Ingemar S. J. Merkies
The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial
Linda L. D. Zhong, Wai Kun, Tsz Fung Lam, Shi Ping Zhang, Jun Jun Yang, Tat Chi Ziea, Bacon Ng, Zhao Xiang Bian
Effect of prebiotic intake on gut microbiota, intestinal permeability and glycemic control in children with type 1 diabetes: study protocol for a randomized controlled trial
Josephine Ho, Raylene A. Reimer, Manpreet Doulla, Carol Huang
Varied flushing frequency and volume to prevent peripheral intravenous catheter failure: a pilot, factorial randomised controlled trial in adult medical-surgical hospital patients
Samantha Keogh, Julie Flynn, Nicole Marsh, Gabor Mihala, Karen Davies, Claire Rickard
The Sources of Strength Australia Project: study protocol for a cluster randomised controlled trial
Alison L. Calear, Jacqueline L. Brewer, Philip J. Batterham, Andrew Mackinnon, Peter A. Wyman, Mark LoMurray, Fiona Shand, Dominique Kazan, Helen Christensen
Acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy in patients without systemic sedation: results of a single-center, double-blinded, randomized controlled trial (DRKS00000164)
Anja Schaible, Katja Schwan, Thomas Bruckner, Konstanze Plaschke, Markus W. Büchler, Markus Weigand, Peter Sauer, Christian Bopp, Phillip Knebel
Guided self-help cognitive behavioral intervention for VoicEs (GiVE): study protocol for a pilot randomized controlled trial
Cassie M. Hazell, Mark Hayward, Kate Cavanagh, Anna-Marie Jones, Clara Strauss
Guided Internet-delivered cognitive behavioural therapy in patients with non-cardiac chest pain – a pilot randomized controlled study
Ghassan Mourad, Anna Strömberg, Egil Jonsbu, Mikael Gustafsson, Peter Johansson, Tiny Jaarsma
Vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomised controlled trial
Megan E. Jensen, Genevieve Mailhot, Nathalie Alos, Elizabeth Rousseau, John H. White, Ali Khamessan, Francine M. Ducharme
Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial
Jie-shu You, Jian-ping Chen, Jessie S.M. Chan, Ho-fun Lee, Mei-kuen Wong, Wing-Fai Yeung, Li-xing Lao
Motivating smokers at outdoor public smoking hotspots to have a quit attempt with a nicotine replacement therapy sample: study protocol for a randomized controlled trial
Yee Tak Derek Cheung, Jessica Pui Kei Leung, Chelsia Ka Ching Cheung, William Ho Cheung Li, Man Ping Wang, Tai Hing Lam
Mass mosquito trapping for malaria control in western Kenya: study protocol for a stepped wedge cluster-randomised trial
Alexandra Hiscox, Tobias Homan, Collins K. Mweresa, Nicolas Maire, Aurelio Di Pasquale, Daniel Masiga, Prisca A. Oria, Jane Alaii, Cees Leeuwis, Wolfgang R. Mukabana, Willem Takken, Thomas A. Smith
Erratum to: 'Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial'
Ze-Huai Wen, Mei-Ling Xuan, Yu-Hong Yan, Xiao-Yan Li, Dan-Ni Yao, Geng Li, Xin-Feng Guo, Ai-Hua Ou, Chuan-Jian Lu
Standardised Chinese herbal treatment delivered by GPs compared with individualised treatment administered by practitioners of Chinese herbal medicine for women with recurrent urinary tract infections (RUTI): study protocol for a randomised controlled trial
Andrew Flower, Kim Harman, George Lewith, Michael Moore, Felicity L. Bishop, Beth Stuart, Nicholas Lampert
A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis
Wei Liu, Yuan-Hao Wu, Si-Yuan Hu, Cheng-Liang Zhong, Ming-Li Gao, Dong-Wu Liu, Hai-Yun Wang, Mu-Zhi Chen, Yue-Jin Song, Ben-Zha-Xi Yang, Qing-Shan Zheng, Hua Yao, Xue-Bing Qi, Gang Li
Development of a core outcome set for use in determining the overall success of gastroschisis treatment
Benjamin Allin, Andrew Ross, Sean Marven, Nigel J Hall, Marian Knight
A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers
Francis H. Y. Green, Richard Leigh, Morenike Fadayomi, Gurkeet Lalli, Andrea Chiu, Grishma Shrestha, Sharif G. ElShahat, David Evan Nelson, Tamer Y. El Mays, Cora A. Pieron, John H. Dennis
Coping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: study protocol for two randomised controlled trials
Alexandra C. De Young, Ann-Christin Haag, Justin A. Kenardy, Roy M. Kimble, Markus A. Landolt
Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial
Patrizia Gnagnarella, Daniele Dragà, Federica Baggi, Maria Claudia Simoncini, Annarita Sabbatini, Ketti Mazzocco, Fabio Domenico Bassi, Gabriella Pravettoni, Patrick Maisonneuve
The experience of adolescents participating in a randomised clinical trial in the field of mental health: a qualitative study
Nick Midgley, Danny Isaacs, Katharina Weitkamp, Mary Target
Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial
Áine Aventin, Maria Lohan, Lisa Maguire, Mike Clarke
Hepatitis C – Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial
Kirsty Roberts, John Macleod, Chris Metcalfe, Joanne Simon, Jeremy Horwood, William Hollingworth, Sharon Marlowe, Fiona H. Gordon, Peter Muir, Barbara Coleman, Peter Vickerman, Graham I. Harrison, Cherry-Ann Waldron, William Irving, Matthew Hickman
Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong
Henry C. Y. Ho, Moses Mui, Alice Wan, Yin-lam Ng, Sunita M. Stewart, Carol Yew, Tai Hing Lam, Sophia S. Chan
Effects of lifestyle intervention in BRCA1/2 mutation carriers on nutrition, BMI, and physical fitness (LIBRE study): study protocol for a randomized controlled trial
Marion Kiechle, Christoph Engel, Anika Berling, Katrin Hebestreit, Stephan C. Bischoff, Ricarda Dukatz, Michael Siniatchkin, Katharina Pfeifer, Sabine Grill, Maryam Yahiaoui-Doktor, Ellen Kirsch, Uwe Niederberger, Ute Enders, Markus Löffler, Alfons Meindl, Kerstin Rhiem, Rita Schmutzler, Nicole Erickson, Martin Halle
Efficacy of ultra-micronized palmitoylethanolamide (um-PEA) in geriatric patients with chronic pain: study protocol for a series of N-of-1 randomized trials
Maura Marcucci, Federico Germini, Anna Coerezza, Luca Andreinetti, Lorenzo Bellintani, Alessandro Nobili, Paolo Dionigi Rossi, Daniela Mari
Towards onset prevention of cognition decline in adults with Down syndrome (The TOP-COG study): A pilot randomised controlled trial
Sally-Ann Cooper, Temitope Ademola, Muriel Caslake, Elizabeth Douglas, Jonathan Evans, Nicola Greenlaw, Caroline Haig, Angela Hassiotis, Andrew Jahoda, Alex McConnachie, Jill Morrison, Howard Ring, John Starr, Ciara Stiles, Chammy Sirisena, Frank Sullivan
The Cognitive Remediation in Bipolar (CRiB) pilot study: study protocol for a randomised controlled trial
Rebecca Strawbridge, Jessica Fish, Rozmin Halari, John Hodsoll, Clare Reeder, Karine Macritchie, Paul McCrone, Til Wykes, Allan H. Young
Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial
Itxaso González-Ortega, Enrique Echeburúa, Adriana García-Alocén, Patricia Vega, Ana González-Pinto
Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project
William J. Meurer, Laurie Legocki, Samkeliso Mawocha, Shirley M. Frederiksen, Timothy C. Guetterman, William Barsan, Roger Lewis, Donald Berry, Michael Fetters
Randomized controlled trials: who fails run-in?
Judy R. Rees, Leila A. Mott, Elizabeth L. Barry, John A. Baron, Jane C. Figueiredo, Douglas J. Robertson, Robert S. Bresalier, Janet L. Peacock
Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial
Salima Punja, Catherine J. Nikles, Hugh Senior, Geoffrey Mitchell, Christopher H. Schmid, Helen Heussler, Manisha Witmans, Sunita Vohra
Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies
Annabelle South, Bec Hanley, Mitzy Gafos, Ben Cromarty, Richard Stephens, Kate Sturgeon, Karen Scott, William J. Cragg, Conor D. Tweed, Jacqueline Teera, Claire L. Vale
Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial—PROSPECT: a pilot trial
Deborah J. Cook, Jennie Johnstone, John C. Marshall, Francois Lauzier, Lehana Thabane, Sangeeta Mehta, Peter M. Dodek, Lauralyn McIntyre, Joe Pagliarello, William Henderson, Robert W. Taylor, Rodrigo Cartin-Ceba, Eyal Golan, Margaret Herridge, Gordon Wood, Daniel Ovakim, Tim Karachi, Michael G. Surette, Dawn M. E. Bowdish, Daphnee Lamarche, Chris P. Verschoor, Erick H. Duan, Diane Heels-Ansdell, Yaseen Arabi, Maureen Meade
Endothelial Dysfunction in Resuscitated Cardiac Arrest (ENDO-RCA): safety and efficacy of low-dose prostacyclin administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac arrest syndrome patients: study protocol for a randomized controlled trial
Anna Sina P. Meyer, Sisse R. Ostrowski, Jesper Kjaergaard, Pär I. Johansson, Christian Hassager
Statistical analysis plan for the PlAtelet Transfusion in Cerebral Haemorrhage (PATCH) trial: a multicentre randomised controlled trial
M. Irem Baharoglu, Rustam Al-Shahi Salman, Charlotte Cordonnier, Rob J. de Haan, Yvo B. W. E. M. Roos
Transcranial direct current stimulation in post-stroke sub-acute aphasia: study protocol for a randomized controlled trial
Kerstin Spielmann, W. Mieke E. van de Sandt-Koenderman, Majanka H. Heijenbrok-Kal, Gerard M. Ribbers
Exercise strategies to protect against the impact of short-term reduced physical activity on muscle function and markers of health in older men: study protocol for a randomised controlled trial
Oliver J. Perkin, Rebecca L. Travers, Javier T. Gonzalez, James E. Turner, Fiona Gillison, Cassie Wilson, Polly M. McGuigan, Dylan Thompson, Keith A. Stokes
Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial
Simone Regina Posser, Carine Cristina Callegaro, Marina Beltrami-Moreira, Leila Beltrami Moreira
A phase III, multi-centre, double-masked randomised controlled trial of adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): statistical analysis plan
Jessica W. Lo, Catey Bunce, David Charteris, Philip Banerjee, Rachel Phillips, Victoria R. Cornelius
Targeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S): study protocol and statistical analysis plan for a randomized controlled trial
Ville Pettilä, Tobias Merz, Erika Wilkman, Anders Perner, Sari Karlsson, Theis Lange, Johanna Hästbacka, Peter Buhl Hjortrup, Anne Kuitunen, Stephan M. Jakob, Jukka Takala
A single-blind, dose escalation, phase I study of high-fluence light-emitting diode-red light (LED-RL) on human skin: study protocol for a randomized controlled trial
Derek Ho, Ekaterina Kraeva, Ted Wun, R. Rivkah Isseroff, Jared Jagdeo
A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study)
Barbara Clyne, Janine A. Cooper, Carmel M. Hughes, Tom Fahey, Susan M. Smith
European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries
Annet Kleiboer, Jan Smit, Judith Bosmans, Jeroen Ruwaard, Gerhard Andersson, Naira Topooco, Thomas Berger, Tobias Krieger, Cristina Botella, Rosa Baños, Karine Chevreul, Ricardo Araya, Arlinda Cerga-Pashoja, Roman Cieślak, Anna Rogala, Christiaan Vis, Stasja Draisma, Anneke van Schaik, Lise Kemmeren, David Ebert, Matthias Berking, Burkhardt Funk, Pim Cuijpers, Heleen Riper
Cool Runnings – an app-based intervention for reducing hot drink scalds: study protocol for a randomised controlled trial
J. D. Burgess, C. M. Cameron, K. Watt, R. M. Kimble
Treatment with l-citrulline and metformin in Duchenne muscular dystrophy: study protocol for a single-centre, randomised, placebo-controlled trial
Patricia Hafner, Ulrike Bonati, Daniela Rubino, Vanya Gocheva, Thomas Zumbrunn, Nuri Gueven, Dirk Fischer
Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial
Yaseen M Arabi, Sami Alsolamy, Abdulaziz Al-Dawood, Awad Al-Omari, Fahad Al-Hameed, Karen E. A. Burns, Mohammed Almaani, Hani Lababidi, Ali Al Bshabshe, Sangeeta Mehta, Abdulsalam M. Al-Aithan, Yasser Mandourah, Ghaleb Almekhlafi, Simon Finfer, Sheryl Ann I. Abdukahil, Lara Y. Afesh, Maamoun Dbsawy, Musharaf Sadat
Effect of medication timing on anticoagulation stability in users of warfarin (the INRange RCT): study protocol for a randomized controlled trial
Balraj S. Heran, G. Michael Allan, Lee Green, Christina Korownyk, Michael Kolber, Nicole Olivier, Mary Flesher, Scott Garrison
The efficacy of Cognitive training in patients with VAsCular Cognitive Impairment, No dEmentia (the Cog-VACCINE study): study protocol for a randomized controlled trial
Yi Tang, Zude Zhu, Qing Liu, Fang Li, Jianwei Yang, Fangyu Li, Yi Xing, Jianping Jia
A school-based health promotion programme to increase help-seeking for substance use and mental health problems: study protocol for a randomised controlled trial
Dan I. Lubman, Bonita J. Berridge, Fiona Blee, Anthony F. Jorm, Coralie J. Wilson, Nicholas B. Allen, Lisa McKay-Brown, Jenny Proimos, Ali Cheetham, Rory Wolfe
ACEMg-mediated hearing preservation in cochlear implant patients receiving different electrode lengths (PROHEARING): study protocol for a randomized controlled trial
Verena Scheper, Melanie Leifholz, Heiko von der Leyen, Miriam Keller, Ute Denkena, Armin Koch, Annika Karch, Josef Miller, Thomas Lenarz
The Post-Anaesthesia N-acetylcysteine Cognitive Evaluation (PANACEA) trial: study protocol for a randomised controlled trial
David R. Skvarc, Olivia M. Dean, Linda K. Byrne, Laura J. Gray, Kathryn Ives, Stephen E. Lane, Matthew Lewis, Cameron Osborne, Richard Page, Douglas Stupart, Alyna Turner, Michael Berk, Andrew J. Marriott
The role of qualitative research in adding value to a randomised controlled trial: lessons from a pilot study of a guided e-learning intervention for managers to improve employee wellbeing and reduce sickness absence
Jill Russell, Lee Berney, Stephen Stansfeld, Doris Lanz, Sally Kerry, Tarani Chandola, Kamaldeep Bhui
Counteracting Age-related Loss of Skeletal Muscle Mass: a clinical and ethnological trial on the role of protein supplementation and training load (CALM Intervention Study): study protocol for a randomized controlled trial
Rasmus Leidesdorff Bechshøft, Søren Reitelseder, Grith Højfeldt, Josué Leonardo Castro-Mejía, Bekzod Khakimov, Hajar Fauzan Bin Ahmad, Michael Kjær, Søren Balling Engelsen, Susanne Margrete Bølling Johansen, Morten Arendt Rasmussen, Aske Juul Lassen, Tenna Jensen, Nina Beyer, Anja Serena, Frederico Jose Armando Perez-Cueto, Dennis Sandris Nielsen, Astrid Pernille Jespersen, Lars Holm
The use of everolimus in the treatment of neurocognitive problems in tuberous sclerosis (TRON): study protocol for a randomised controlled trial
Elizabeth Randell, Rachel McNamara, D. Mark Davies, Eleri Owen-Jones, Nigel Kirby, Lianna Angel, Cheney Drew, Rebecca Cannings-John, Michelle Smalley, Anurag Saxena, Emer McDermott, Laura Stockwell, Petrus J. de Vries, Kerry Hood, Julian R. Sampson
The preventative role of exogenous melatonin administration to patients with advanced cancer who are at risk of delirium: study protocol for a randomized controlled trial
Shirley Harvey Bush, Nathalie Lacaze-Masmonteil, Marie Theresa McNamara-Kilian, Alistair Richard MacDonald, Sallyanne Tierney, Franco Momoli, Meera Agar, David Christopher Currow, Peter Gerard Lawlor
Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial
Phyllis J. Goodman, Catherine M. Tangen, Amy K. Darke, Kathryn B. Arnold, JoAnn Hartline, Monica Yee, Karen Anderson, Allison Caban-Holt, William G. Christen, Patricia A. Cassano, Peter Lance, Eric A. Klein, John J. Crowley, Lori M. Minasian, Frank L. Meyskens
Standardised Outcomes in Nephrology—Children and Adolescents (SONG-Kids): a protocol for establishing a core outcome set for children with chronic kidney disease
Allison Tong, Susan Samuel, Michael Zappitelli, Allison Dart, Susan Furth, Allison Eddy, Jaap Groothoff, Nicholas J. A. Webb, Hui-Kim Yap, Detlef Bockenhauer, Aditi Sinha, Stephen I. Alexander, Stuart L. Goldstein, Debbie S. Gipson, Camilla S. Hanson, Nicole Evangelidis, Sally Crowe, Tess Harris, Brenda R. Hemmelgarn, Braden Manns, John Gill, Peter Tugwell, Wim Van Biesen, David C. Wheeler, Wolfgang C. Winkelmayer, Jonathan C. Craig
Intra-cluster and inter-period correlation coefficients for cross-sectional cluster randomised controlled trials for type-2 diabetes in UK primary care
James Martin, Alan Girling, Krishnarajah Nirantharakumar, Ronan Ryan, Tom Marshall, Karla Hemming
Effects of early, combined endurance and resistance training in mechanically ventilated, critically ill patients: a study protocol for a randomised controlled trial
Sabrina Eggmann, Martin L. Verra, Gere Luder, Jukka Takala, Stephan M. Jakob
One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial
Cyril Villat, Jean-Pierre Attal, Nathalie Brulat, Franck Decup, Sophie Doméjean, Elisabeth Dursun, Hélène Fron-Chabouis, Bruno Jacquot, Michèle Muller Bolla, Nelly Plasse-Pradelle, Laurent Roche, Delphine Maucort-Boulch, Patrice Nony, Kerstin Gritsch, Pierre Millet, François Gueyffier, Brigitte Grosgogeat
Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial
Renata Calhes Franco Moura, Cibele Almeida Santos, Luanda André Collange Grecco, Roberta Delasta Lazzari, Arislander Jonathan Lopes Dumont, Natalia Carvalho de Almeida Duarte, Luiz Alfredo Braun, Jamile Benite Palma Lopes, Ligia Abram dos Santos, Eliane Lopes Souza Rodrigues, Giorgio Albertini, Veronica Cimolin, Manuela Galli, Claudia Santos Oliveira
Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice
Cylie M. Williams, Elizabeth H. Skinner, Alicia M. James, Jill L. Cook, Steven M. McPhail, Terry P. Haines
One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial
Shu-bo Pan, Wei Geng, Da-chen Zhou, Jiang-ming Chen, Hong-chuan Zhao, Fu-bao Liu, Sheng-xue Xie, Hui Hou, Yi-jun Zhao, Kun Xie, Guo-bin Wang, Xiao-ping Geng
A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial
Diana Man Ka Chan, Ka Wang Cheung, Sofie Shuk Fei Yung, Vivian Chi Yan Lee, Raymond Hang Wun Li, Ernest Hung Yu Ng
Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development
Sara T. Brookes, Rhiannon C. Macefield, Paula R. Williamson, Angus G. McNair, Shelley Potter, Natalie S. Blencowe, Sean Strong, Jane M. Blazeby
Modafinil In Debilitating fatigue After Stroke (MIDAS): study protocol for a randomised, double-blinded, placebo-controlled, crossover trial
Thomas Lillicrap, Venkatesh Krishnamurthy, John Attia, Michael Nilsson, Christopher R. Levi, Mark W. Parsons, Andrew Bivard
Stability of Unicortical versus Bicortical Metacarpal Fracture Internal Fixation Trial (SUBMIT): study protocol for a randomized controlled trial
Feiran Wu, Katie Young, Mohammad Shahid, Peter Nightingale, Surabhi Choudhary, Michael Craigen, Rajive Jose, Mark Foster
Effect of Xinyue capsules on patients with coronary heart disease after percutaneous coronary intervention: study protocol for a randomized controlled trial
Ming Guo, Ming-jie Zi, Rui-xi Xi, Qiao-ning Yang, Rui-na Bai, Yi-sheng Zhang, Yu-hua Wang, Pei-li Wang, Da-zhuo Shi
Effects of a high-intensity interval training program versus a moderate-intensity continuous training program on maximal oxygen uptake and blood pressure in healthy adults: study protocol for a randomized controlled trial
Víctor Hugo Arboleda Serna, Elkin Fernando Arango Vélez, Rubén Darío Gómez Arias, Yuri Feito
Efficacy of a new technique – INtubate-RECruit-SURfactant-Extubate – “IN-REC-SUR-E” – in preterm neonates with respiratory distress syndrome: study protocol for a randomized controlled trial
Giovanni Vento, Roberta Pastorino, Luca Boni, Francesco Cota, Virgilio Carnielli, Filip Cools, Carlo Dani, Fabio Mosca, Jane Pillow, Graeme Polglase, Paolo Tagliabue, Anton H. van Kaam, Maria Luisa Ventura, Milena Tana, Chiara Tirone, Claudia Aurilia, Alessandra Lio, Cinzia Ricci, Alessandro Gambacorta, Chiara Consigli, Danila D’Onofrio, Camilla Gizzi, Luca Massenzi, Viviana Cardilli, Alessandra Casati, Roberto Bottino, Federica Pontiggia, Elena Ciarmoli, Stefano Martinelli, Laura Ilardi, Mariarosa Colnaghi, Piero Giuseppe Matassa, Valentina Vendettuoli, Paolo Villani, Francesca Fusco, Diego Gazzolo, Alberto Ricotti, Federica Ferrero, Ilaria Stasi, Rosario Magaldi, Gianfranco Maffei, Giuseppe Presta, Roberto Perniola, Francesco Messina, Giovanna Montesano, Chiara Poggi, Lucio Giordano, Enza Roma, Carolina Grassia, Gaetano Ausanio, Fabrizio Sandri, Giovanna Mescoli, Francesco Giura, Giampaolo Garani, Agostina Solinas, Maria Lucente, Gabriella Nigro, Antonello Del Vecchio, Flavia Petrillo, Luigi Orfeo, Lidia Grappone, Lorenzo Quartulli, Antonio Scorrano, Hubert Messner, Alex Staffler, Giancarlo Gargano, Eleonora Balestri, Stefano Nobile, Caterina Cacace, Valerio Meli, Sara Dallaglio, Betta Pasqua, Loretta Mattia, Eloisa Gitto, Marcello Vitaliti, Maria Paola Re, Stefania Vedovato, Alessandra Grison, Alberto Berardi, Francesco Torcetta, Isotta Guidotti, Sandra di Fabio, Eugenia Maranella, Isabella Mondello, Stefano Visentin, Francesca Tormena
Baclofen to prevent agitation in alcohol-addicted patients in the ICU: study protocol for a randomised controlled trial
Mickael Vourc’h, Fanny Feuillet, Pierre-Joachim Mahe, Véronique Sebille, Karim Asehnoune
Using discrete choice experiments as a decision aid in total knee arthroplasty: study protocol for a randomised controlled trial
Michelle M. Dowsey, Anthony Scott, Elizabeth A. Nelson, Jinhu Li, Vijaya Sundararajan, Mandana Nikpour, Peter F. M. Choong
Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial
Joanne Wilcox, Chantelle Waite, Lyndsey Tomlinson, Joanne Driscoll, Asra Karim, Edward Day, Adnan Sharif
Evaluation of the anti-fatigue effects of a traditional herbal drug, Gongjin-dan, under insufficient sleep conditions: study protocol for a randomised controlled trial
Mi Ju Son, Hwi-Jin Im, Young-Eun Kim, Boncho Ku, Jun-Hwan Lee, Chang-Gue Son
Stakeholders’ views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs
Shona Kalkman, Ghislaine J. M. W. van Thiel, Diederick E. Grobbee, Anna-Katharina Meinecke, Mira G. P. Zuidgeest, Johannes J. M. van Delden
Erratum to: Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial
Yaseen M. Arabi, Sami Alsolamy, Abdulaziz Al-Dawood, Awad Al-Omari, Fahad Al-Hameed, Karen E. A. Burns, Mohammed Almaani, Hani Lababidi, Ali Al Bshabshe, Sangeeta Mehta, Abdulsalam M. Al-Aithan, Yasser Mandourah, Ghaleb Almekhlafi, Simon Finfer, Sheryl Ann I. Abdukahil, Lara Y. Afesh, Maamoun Dbsawy, Musharaf Sadat
Endovenous laser ablation versus mechanochemical ablation with ClariVein® in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial
Clement C. M. Leung, Daniel Carradice, Tom Wallace, Ian C. Chetter
Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial
Jin-Bae Kim, Hyun Jun Joung, Jung Myung Lee, Jong Shin Woo, Woo-shik Kim, Kwon Sam Kim, Kyung Hye Lee, Weon Kim
The impact of long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence: study protocol for a cluster randomized controlled trial
Guofa Zhou, Virginia Wiseman, Harrysone E. Atieli, Ming-Chieh Lee, Andrew K. Githeko, Guiyun Yan
Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial
Peter A. Coventry, Peter Bower, Amy Blakemore, Liz Baker, Mark Hann, Angela Paisley, Charlotte Renwick, Jinshuo Li, Atushi Ugajin, Martin Gibson
Walking adaptability therapy after stroke: study protocol for a randomized controlled trial
Celine Timmermans, Melvyn Roerdink, Marielle W. van Ooijen, Carel G. Meskers, Thomas W. Janssen, Peter J. Beek
Representativeness of the participants in the smoking Cessation in Pregnancy Incentives Trial (CPIT): a cross-sectional study
Barnabas Bessing, Linda Bauld, Lesley Sinclair, Daniel F. Mackay, William Spence, David M. Tappin
Family psychoeducation for major depressive disorder – study protocol for a randomized controlled trial
Nina Timmerby, Stephen F. Austin, Kristian Ussing, Per Bech, Claudio Csillag
A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization
Alexandra R. Brown, Byron J. Gajewski, Lauren S. Aaronson, Dinesh Pal Mudaranthakam, Suzanne L. Hunt, Scott M. Berry, Melanie Quintana, Mamatha Pasnoor, Mazen M. Dimachkie, Omar Jawdat, Laura Herbelin, Richard J. Barohn
Development of a core outcome set for clinical trials in rosacea: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey
Sanjana Iyengar, Paula R. Williamson, Jochen Schmitt, Lena Johannsen, Ian A. Maher, Joseph F. Sobanko, Todd V. Cartee, Daniel Schlessinger, Emily Poon, Murad Alam
Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish
Paola Rosati, Franz Porzsolt, Gabriella Ricciotti, Giuseppina Testa, Rita Inglese, Ferruccio Giustini, Ersilia Fiscarelli, Marco Zazza, Cecilia Carlino, Valerio Balassone, Roberto Fiorito, Roberto D’Amico
How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction)
Natalie Bidad, Lindsay MacDonald, Zoë E. Winters, Sarah J. L. Edwards, Marie Emson, Clare L. Griffin, Judith Bliss, Rob Horne
Evaluation of low-level laser at auriculotherapy points to reduce postoperative pain in inferior third molar surgery: study protocol for a randomized controlled trial
Hélio Sampaio-Filho, Juliane Sotto-Ramos, Erika Horácio Pinto, Marcia Regina Cabral, Priscila Larcher Longo, Isabel Peixoto Tortamano, Rodrigo Labat Marcos, Daniela Fátima Teixeira Silva, Christine Pavani, Anna Carolina Ratto Tempestini Horliana
Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study)
Fernanda de Souza Nogueira Sardinha Mendes, Andréa Silvestre Sousa, Fernando Cesar de Castro Cesar Souza, Vivian Liane Mattos Pinto, Paula Simplicio Silva, Roberto Magalhães Saraiva, Sergio Salles Xavier, Henrique Horta Veloso, Marcelo Teixeira Holanda, Andréa Rodrigues Costa, Fernanda Martins Carneiro, Gilberto Marcelo Sperandio Silva, Juliana Pereira Borges, Eduardo Tibirica, Roberta Olmo Pinheiro, Flávio Alves Lara, Alejandro Marcel Hasslocher-Moreno, Pedro Emmanuel Alvarenga Americano Brasil, Mauro Felippe Felix Mediano
Practice facilitation for improving cardiovascular care: secondary evaluation of a stepped wedge cluster randomized controlled trial using population-based administrative data
Catherine Deri Armstrong, Monica Taljaard, William Hogg, Amy E. Mark, Clare Liddy
EMBalance - validation of a decision support system in the early diagnostic evaluation and management plan formulation of balance disorders in primary care: study protocol of a feasibility randomised controlled trial
Laura Rammazzo, Dimitris Kikidis, Amal Anwer, Nora Macdonald, Efthymios Kyrodimos, Christoph Maurer, Floris Wuyts, Linda Luxon, Athanasios Bibas, Doris-Eva Bamiou
Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial
Fred Stephen Sarfo, Frank Treiber, Carolyn Jenkins, Sachin Patel, Mulugeta Gebregziabher, Arti Singh, Osei Sarfo-Kantanka, Raelle Saulson, Lambert Appiah, Eunice Oparebea, Bruce Ovbiagele
Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial
Vera Lucia Portal, Melissa Medeiros Markoski, Alexandre Schaan de Quadros, Sílvia Garofallo, Julia Lorenzon dos Santos, Aline Oliveira, Camila Wechenfelder, Viviane Paiva de Campos, Priscilla Azambuja Lopes de Souza, Luana Machado, Aline Marcadenti
Increased risk of type I errors in cluster randomised trials with small or medium numbers of clusters: a review, reanalysis, and simulation study
Brennan C. Kahan, Gordon Forbes, Yunus Ali, Vipul Jairath, Stephen Bremner, Michael O. Harhay, Richard Hooper, Neil Wright, Sandra M. Eldridge, Clémence Leyrat
The impact of a knowledge translation intervention employing educational outreach and a point-of-care reminder tool vs standard lay health worker training on tuberculosis treatment completion rates: study protocol for a cluster randomized controlled trial
Lisa M. Puchalski Ritchie, Monique van Lettow, Austine Makwakwa, Adrienne K. Chan, Jemila S. Hamid, Harry Kawonga, Alexandra L. C. Martiniuk, Michael J. Schull, Vanessa van Schoor, Merrick Zwarenstein, Jan Barnsley, Sharon E. Straus
Erratum to: ‘Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies’
Annabelle South, Bec Hanley, Mitzy Gafos, Ben Cromarty, Richard Stephens, Kate Sturgeon, Karen Scott, William J. Cragg, Conor D. Tweed, Jacqueline Teera, Claire L. Vale
Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial
Cathryn Glazener, Lynda Constable, Christine Hemming, Suzanne Breeman, Andrew Elders, Kevin Cooper, Robert Freeman, Anthony R. B. Smith, Suzanne Hagen, Alison McDonald, Gladys McPherson, Isobel Montgomery, Mary Kilonzo, Dwayne Boyers, Beatriz Goulao, John Norrie
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
The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research
Christopher Megone, Eleanor Wilman, Sandy Oliver, Lelia Duley, Gill Gyte, Judy Wright
The Mental Health in Diabetes Service (MINDS) to enhance psychosocial health: study protocol for a randomized controlled trial
Casey L. O’Brien, Chantal F. Ski, David R. Thompson, Gaye Moore, Serafino Mancuso, Alicia Jenkins, Glenn Ward, Richard J. MacIsaac, Margaret Loh, Simon R. Knowles, Susan L. Rossell, David J. Castle
Trialling of an optimal health programme (OHP) across chronic disease
Chantal F. Ski, David R. Thompson, David J. Castle
The Stroke and Carer Optimal Health Program (SCOHP) to enhance psychosocial health: study protocol for a randomized controlled trial
Catherine Brasier, Chantal F. Ski, David R. Thompson, Jan Cameron, Casey L. O’Brien, Nicola T. Lautenschlager, Graeme Gonzales, Ya-seng Arthur Hsueh, Gaye Moore, Simon R. Knowles, Susan L. Rossell, Rachel Haselden, David J. Castle
Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial
Simon R. Knowles, Chantal F. Ski, Robyn Langham, Emmet O’Flaherty, David R. Thompson, Susan L. Rossell, Gaye Moore, Ya-seng (Arthur) Hsueh, David J. Castle
Prevention of catheter-related bladder discomfort – pudendal nerve block with ropivacaine versus intravenous tramadol: study protocol for a randomized controlled trial
Jing-yi Li, Ren Liao
How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline
Cecilia A. C. Prinsen, Sunita Vohra, Michael R. Rose, Maarten Boers, Peter Tugwell, Mike Clarke, Paula R. Williamson, Caroline B. Terwee
Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l’Insuffisance Respiratoire Aigue - Mus-IRA)
Jonathan Messika, David Hajage, Nataly Panneckoucke, Serge Villard, Yolaine Martin, Emilie Renard, Annie Blivet, Jean Reignier, Natacha Maquigneau, Annabelle Stoclin, Christelle Puechberty, Stéphane Guétin, Aline Dechanet, Amandine Fauquembergue, Stéphane Gaudry, Didier Dreyfuss, Jean-Damien Ricard
Qing-Xin-Jie-Yu Granules in addition to conventional treatment for patients with stable coronary artery disease (QUEST Trial): study protocol for a randomized controlled trial
Shengyao Li, Ming Guo, Huimin Mao, Zhuye Gao, Hao Xu, Dazhuo Shi
Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial
Gregory E. Simon, Arne Beck, Rebecca Rossom, Julie Richards, Beth Kirlin, Deborah King, Lisa Shulman, Evette J. Ludman, Robert Penfold, Susan M. Shortreed, Ursula Whiteside
Cancer@Work — a nurse-led, stepped-care, e-health intervention to enhance the return to work of patients with cancer: study protocol for a randomized controlled trial
Sietske J. Tamminga, Jan L. Hoving, Monique H. W. Frings-Dresen, Angela G. E. M. de Boer
Hughes Abdominal Repair Trial (HART) – Abdominal wall closure techniques to reduce the incidence of incisional hernias: study protocol for a randomised controlled trial
J. Cornish, R. L. Harries, D. Bosanquet, B. Rees, J. Ansell, N. Frewer, P. K. Dhruva Rao, C. Parry, R. Ellis-Owen, S. M. Phillips, C. Morris, J. Horwood, M. L. Davies, M. M. Davies, R. Hargest, Z. Davies, J. Hilton, D. Harris, A. Ben-Sassi, R. Rajagopal, D. Hanratty, S. Islam, A. Watkins, N. Bashir, S. Jones, I. R. Russell, J. Torkington
Guided Act and Feel Indonesia (GAF-ID) – Internet-based behavioral activation intervention for depression in Indonesia: study protocol for a randomized controlled trial
Retha Arjadi, Maaike H. Nauta, Willem F. Scholte, Steven D. Hollon, Neerja Chowdhary, Angela O. Suryani, Claudi L. H. Bockting
Chemotherapy plus Ofatumumab at Standard or Mega dose in relapsed CLL (COSMIC) trial: study protocol for a phase II randomised controlled trial
Dena R. Howard, Talha Munir, Anna Hockaday, Andy C. Rawstron, Laura Collett, Jamie B. Oughton, David Allsup, Adrian Bloor, David Phillips, Peter Hillmen
The effect of chiropractic treatment on the reaction and response times of special operation forces military personnel: study protocol for a randomized controlled trial
James W. DeVocht, Dean L. Smith, Cynthia R. Long, Lance Corber, Bridget Kane, Thomas M. Jones, Christine M. Goertz
Recruitment and representativeness of blood donors in the INTERVAL randomised trial assessing varying inter-donation intervals
Carmel Moore, Thomas Bolton, Matthew Walker, Stephen Kaptoge, David Allen, Michael Daynes, Susan Mehenny, Jennifer Sambrook, Nicholas A. Watkins, Gail Miflin, Emanuele Di Angelantonio, Willem H. Ouwehand, David J. Roberts, John Danesh, Simon G. Thompson
Lapatinib-capecitabine versus capecitabine alone as radiosensitizers in RAS wild-type resectable rectal cancer, an adaptive randomized phase II trial (LaRRC trial): study protocol for a randomized controlled trial
Nuno Sousa, Olga Sousa, Lúcio Lara Santos, Rui Henrique, Manuel R. Teixeira, Mário Dinis-Ribeiro, Armando Teixeira-Pinto
A home-based exercise intervention for caregivers of persons with dementia: study protocol for a randomised controlled trial
Wai Chi Chan, Nicola Lautenschlager, Briony Dow, Suk Ling Ma, Corine Sau Man Wong, Linda Chiu Wa Lam
Effectiveness and cost-effectiveness of telephone consultations for fever or gastroenteritis using a formalised procedure in general practice: study protocol of a cluster randomised controlled trial
Paul-Georges Reuter, Thibaut Desmettre, Sabine Guinemer, Olivier Ducros, Stéphane Begey, Agnès Ricard-Hibon, Laurianne Billier, Océane Grignon, Isabelle Megy-Michoux, Jean-Noël Latouff, Adeline Sourbes, Julien Latier, Isabelle Durand-Zaleski, Frédéric Lapostolle, Eric Vicaut, Frédéric Adnet
A multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: study protocol for a randomized controlled trial
Palmira Bernocchi, Simonetta Scalvini, Tiziana Galli, Mara Paneroni, Doriana Baratti, Ottavia Turla, Maria Teresa La Rovere, Maurizio Volterrani, Michele Vitacca
Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery
Shelley Potter, Sara T. Brookes, Christopher Holcombe, Joseph A. Ward, Jane M. Blazeby
A feasibility study to prevent falls in older people who are sight impaired: the VIP2UK randomised controlled trial
Heather Waterman, Claire Ballinger, Caroline Brundle, Sebastien Chastin, Heather Gage, Robert Harper, David Henson, Bob Laventure, Lisa McEvoy, Mark Pilling, Nicky Olleveant, Dawn A Skelton, Penelope Stanford, Chris Todd
Erratum to: ‘Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2): study protocol for a randomised controlled trial’
Thomas P. Hellyer, Niall H. Anderson, Jennie Parker, Paul Dark, Tina Van Den Broeck, Suveer Singh, Ronan McMullan, Ashley M. Agus, Lydia M. Emerson, Bronagh Blackwood, Savita Gossain, Tim S. Walsh, Gavin D. Perkins, Andrew Conway Morris, Daniel F. McAuley, A. John Simpson
The ABBA study – approach bias modification in bulimia nervosa and binge eating disorder: study protocol for a randomised controlled trial
Timo Brockmeyer, Ulrike Schmidt, Hans-Christoph Friederich
Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial
Eliza G. Miller, Caryl A. Nowson, David W. Dunstan, Deborah A. Kerr, Vicky Solah, David Menzies, Robin M. Daly
How to design clinical rehabilitation trials for the upper paretic limb early post stroke?
Caroline Winters, Martijn W. Heymans, Erwin E. H. van Wegen, Gert Kwakkel
Efficacy and mechanisms of imagery rescripting and imaginal exposure for nightmares: study protocol for a randomized controlled trial
Anna E. Kunze, Jaap Lancee, Nexhmedin Morina, Merel Kindt, Arnoud Arntz
Assessment of three fasting plasma glucose targets for insulin glargine-based therapy in people with type 2 diabetes mellitus in China: study protocol for a randomized controlled trial
Wenying Yang, Zhaojun Yang, Jing Zhao, Hai Lu, Tianhong Luo
Metamizole versus ibuprofen at home after day surgery: study protocol for a randomised controlled trial
Björn Stessel, Michiel Boon, Elbert A. Joosten, Jean-Paul Ory, Stefan Evers, Sander M. J. van Kuijk, Jasperina Dubois, Daisy Hoofwijk, Luc Jamaer, Wolfgang F. F. A. Buhre
Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial
Anne Lingford-Hughes, Yash Patel, Owen Bowden-Jones, Mike J. Crawford, Paul I. Dargan, Fabiana Gordon, Steve Parrott, Tim Weaver, David M. Wood
Citation bias favoring positive clinical trials of thrombolytics for acute ischemic stroke: a cross-sectional analysis
Benjamin S. Misemer, Timothy F. Platts-Mills, Christopher W. Jones
Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial
John Muscedere, David Maslove, John Gordon Boyd, Nicole O’Callaghan, Francois Lamontagne, Steven Reynolds, Martin Albert, Rick Hall, Danielle McGolrick, Xuran Jiang, Andrew G. Day
STEPWISE – STructured lifestyle Education for People WIth SchizophrEnia: a study protocol for a randomised controlled trial
Rebecca Gossage-Worrall, Richard I. G. Holt, Katharine Barnard, Marian E. Carey, Melanie J. Davies, Chris Dickens, Yvonne Doherty, Charlotte Edwardson, Paul French, Fiona Gaughran, Kathryn Greenwood, Sridevi Kalidindi, Daniel Hind, Kamlesh Khunti, Paul McCrone, Jonathan Mitchell, John Pendlebury, Shanaya Rathod, David Shiers, Najma Siddiqi, Lizzie Swaby, Stephen Wright
Deep brain stimulation of the posterior subthalamic area and the thalamus in patients with essential tremor: study protocol for a randomized controlled pilot trial
Michael T. Barbe, Jeremy Franklin, Daria Kraus, Paul Reker, Till A. Dembek, Niels Allert, Jochen Wirths, Jürgen Voges, Lars Timmermann, Veerle Visser-Vandewalle
Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial
Maijke van Bloemendaal, Sicco A. Bus, Charlotte E. de Boer, Frans Nollet, Alexander C. H. Geurts, Anita Beelen
Realist trials and the testing of context-mechanism-outcome configurations: a response to Van Belle et al.
Chris Bonell, Emily Warren, Adam Fletcher, Russell Viner
Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial
Gustavo José Luvizutto, Gabriela Rizzo Soares Rizzati, Marcelo Ortolani Fogaroli, Rodrigo Thomazi Rodrigues, Priscila Watson Ribeiro, Hélio Rubens de Carvalho Nunes, Gabriel Pereira Braga, Rafael Dalle Molle da Costa, Silméia Garcia Zanati Bazan, Luiz Antônio de Lima Resende, Adriana Bastos Conforto, Rodrigo Bazan
Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial
W. Miles Cox, Leena Subramanian, David E. J. Linden, Michael Lührs, Rachel McNamara, Rebecca Playle, Kerenza Hood, Gareth Watson, Joseph R. Whittaker, Raman Sakhuja, Niklas Ihssen
Collaborative Assessment and Management of Suicidality (CAMS) compared to treatment as usual (TAU) for suicidal patients: study protocol for a randomized controlled trial
Wenche Ryberg, Roar Fosse, Per Henrik Zahl, Inge Brorson, Paul Møller, Nils Inge Landrø, David Jobes
A statistical analysis plan for the efficiency and safety of Chinese herbal medicine used concurrently with topical therapy for psoriasis vulgaris
Liming Lu, Meiling Xuan, Yuhong Yan, Geng Li, Li Zhou, Zehuai Wen, Chuanjian Lu
Assessment of clinical trial participant patient satisfaction: a call to action
Bethann Mangel Pflugeisen, Stacie Rebar, Anne Reedy, Roslyn Pierce, Paul J. Amoroso
Erratum to: Simple steps to develop trial follow-up procedures
Ona McCarthy, Rebecca S. French, Ian Roberts, Caroline Free
The NSPCC UK Minding the Baby® (MTB) home-visiting programme, supporting young mothers (aged 14–25) in the first 2 years of their baby's life: study protocol for a randomised controlled trial
Elena Longhi, Lynne Murray, Rachael Hunter, David Wellsted, Samantha Taylor-Colls, Kathryn MacKenzie, Gwynne Rayns, Richard Cotmore, Peter Fonagy, Richard M. Pasco Fearon
Group schema therapy versus group cognitive behavioral therapy for social anxiety disorder with comorbid avoidant personality disorder: study protocol for a randomized controlled trial
Astrid Baljé, Anja Greeven, Anne van Giezen, Kees Korrelboom, Arnoud Arntz, Philip Spinhoven
Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial
Xixue Zhang, Jionglin Wei, Xiaoxing Song, Yuhao Zhang, Weiqing Qian, Lu Sheng, Zhoujun Shen, Lvjun Yang, Rong Dong, Weidong Gu
Optimising the validity and completion of adherence diaries: a multiple case study and randomised crossover trial
Rachael Frost, Doreen McClurg, Marian Brady, Brian Williams
Scalp acupuncture and electromagnetic convergence stimulation for patients with cerebral infarction: study protocol for a randomized controlled trial
Jae-Young Han, Jae-Hong Kim, Ju-Hyung Park, Min-Yeong Song, Min-Keun Song, Dong-Joo Kim, Young-Nim You, Gwang-Cheon Park, Jin-Bong Choi, Myung-Rae Cho, Jeong-Cheol Shin, Ji-Hyun Cho
Effects of probiotics (Vivomixx®) in obese pregnant women and their newborn: study protocol for a randomized controlled trial
Sofie Ingdam Halkjaer, Lisbeth Nilas, Emma Malchau Carlsen, Dina Cortes, Thórhallur Ingi Halldórsson, Sjúrdur Frodi Olsen, Anders Elm Pedersen, Karen Angeliki Krogfelt, Andreas Munk Petersen
Perioperative and long-term outcomes of liver resection for hepatitis B virus-related hepatocellular carcinoma without versus with hepatic inflow occlusion: study protocol for a prospective randomized controlled trial
Yinzhe Xu, Jiye Chen, Hongguang Wang, Hui Zheng, Dan Feng, Aiqun Zhang, Jianjun Leng, Weidong Duan, Zhanyu Yang, Mingyi Chen, Xianjie Shi, Shouwang Cai, Wenbin Ji, Kai Jiang, Wenzhi Zhang, Yongliang Chen, Wanqing Gu, Jiahong Dong, Shichun Lu
Southampton PRegnancy Intervention for the Next Generation (SPRING): protocol for a randomised controlled trial
Janis Baird, Mary Barker, Nicholas C. Harvey, Wendy Lawrence, Christina Vogel, Megan Jarman, Rufia Begum, Tannaze Tinati, Pamela Mahon, Sofia Strommer, Taylor Rose, Hazel Inskip, Cyrus Cooper
What can we learn from trial decliners about improving recruitment? Qualitative study
Adwoa Hughes-Morley, Bridget Young, Roelie J. Hempel, Ian T. Russell, Waquas Waheed, Peter Bower
The effects of linagliptin on endothelial function and global arginine bioavailability ratio in coronary artery disease patients with early diabetes: study protocol for a randomized controlled trial
Norbert J. Tripolt, Felix Aberer, Regina Riedl, Barbara Hutz, Jasmin Url, Gudrun Dimsity, Andreas Meinitzer, Tatjana Stojakovic, Ronald Hödl, Marianne Brodmann, Franz Hafner, Harald Sourij
The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial
Valery S. Effoe, Jeffrey A. Katula, Julienne K Kirk, Carolyn F Pedley, Linda Y. Bollhalter, W. Mark Brown, Margaret R. Savoca, Stedman T. Jones, Janet Baek, Alain G. Bertoni
Characteristics of men responding to an invitation to undergo testing for prostate cancer as part of a randomised trial
Eleanor I. Walsh, Emma L. Turner, J. Athene Lane, Jenny L. Donovan, David E. Neal, Freddie C. Hamdy, Richard M. Martin, Richard Martin, Jenny Donovan, David Neal, Freddie Hamdy, Emma Turner, Chris Metcalfe, Jonathan Sterne, Sian Noble, Liz Hill, Siaw Yein Ng, Naomi Williams, Liz Down, Eleanor Walsh, Joanna Thorn, Charlotte Davies, Laura Hughes, Mari-Anne Rowlands, Lindsey Bell, Emma Turner, Richard Martin, Jenny Donovan, Chris Metcalfe, Jonathan Sterne, Sian Noble, Yoav Ben-Shlomo, Athene Lane, Steven Oliver, Peter Brindle, Simon Evans, Michael Baum, Peter Albertsen, Tracy Roberts, Mary Robinson, Jan Adolfsson, David Dearnaley, Anthony Zeitman, Fritz Schröder, Tim Peters, Peter Holding, Teresa Lennon, Sue Bonnington, Malcolm Mason, Jon Oxley, Richard Martin, Jenny Donovan, David Neal, Freddie Hamdy, Emma Turner, Athene Lane, Lars Holmberg, Robert Pickard, Simon Thompson, Usha Menon, Peter Albertsen, Colette Reid, Jon McFarlane, Jon Oxley, Mary Robinson, Jan Adolfsson, Michael Baum, Anthony Zeitman, Amit Bahl, Anthony Koupparis, Marta Tazewell, Genevieve Hatton-Brown
Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial
Lianne M. Tomfohr-Madsen, Tavis S. Campbell, Gerald F. Giesbrecht, Nicole L. Letourneau, Linda E. Carlson, Joshua W. Madsen, Sona Dimidjian
FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations
Andrew Skeggs, Tricia McKeever, Lelia Duley, Eleanor Mitchell, Lucy Bradshaw, Kevin Mortimer, Samantha Walker, Steve Parrott, Andrew Wilson, Ian Pavord, Chris Brightling, Mike Thomas, David Price, Graham Devereux, Bernard Higgins, Tim Harrison, Rebecca Haydock
Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial
Jesús Villar, Javier Belda, Jesús Blanco, Fernando Suarez-Sipmann, José Manuel Añón, Lina Pérez-Méndez, Carlos Ferrando, Dácil Parrilla, Raquel Montiel, Ruth Corpas, Elena González-Higueras, David Pestaña, Domingo Martínez, Lorena Fernández, Marina Soro, Miguel Angel García-Bello, Rosa Lidia Fernández, Robert M. Kacmarek
COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): study protocol for a randomised controlled trial
Karen L. Barker, David Beard, Andrew Price, Francine Toye, Martin Underwood, Avril Drummond, Gary Collins, Susan Dutton, Helen Campbell, Nicola Kenealy, Jon Room, Sarah E. Lamb
Effectiveness of a pharmacist-driven intervention in COPD (EPIC): study protocol for a randomized controlled trial
Erin Davis, Carlo Marra, John-Michael Gamble, Jamie Farrell, Joe Lockyer, J. Mark FitzGerald, Waseem Abu-Ashour, Charlie Gillis, John Hawboldt
Depression: an exploratory parallel-group randomised controlled trial of Antenatal guided self help for WomeN (DAWN): study protocol for a randomised controlled trial
Kylee Trevillion, Jill Domoney, Andrew Pickles, Debra Bick, Sarah Byford, Margaret Heslin, Jeannette Milgrom, Rachel Mycroft, Carmine Pariante, Elizabeth Ryan, Myra Hunter, Louise Michele Howard
Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial
Cindy X. Guo, Raiju J. Babu, Joanna M. Black, William R. Bobier, Carly S. Y. Lam, Shuan Dai, Tina Y. Gao, Robert F. Hess, Michelle Jenkins, Yannan Jiang, Lionel Kowal, Varsha Parag, Jayshree South, Sandra Elfride Staffieri, Natalie Walker, Angela Wadham, Benjamin Thompson, Taina Von Blaramberg, Stephen J. Boswell, Arijit Chakraborty, Lily Chan, Simon Clavagnier, Patrick W. C. Ho, Colin Howe, Michelle H. Jen, Lisa Kearns, Joanna Michie, Colleen Ng, John Faafetai Faatui, Peter Pang, Roberto Pieri, Rajkumar Nallour Raveendren, Daniel Spiegel, Stuart L. Uren
Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial
Frans van Workum, Stefan A. W. Bouwense, Misha D. P. Luyer, Grard A. P. Nieuwenhuijzen, Donald L. van der Peet, Freek Daams, Ewout A. Kouwenhoven, Marc J van Det, Frits J. H. van den Wildenberg, Fatih Polat, Suzanne S. Gisbertz, Mark I. van Berge Henegouwen, Joos Heisterkamp, Barbara S. Langenhoff, Ingrid S. Martijnse, Janneke P. Grutters, Bastiaan R. Klarenbeek, Maroeska M. Rovers, Camiel Rosman
Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial
Suguru Kimoto, Yasuhiko Kawai, Atsuko Gunji, Hisatomo Kondo, Taro Nomura, Tomohiko Murakami, Akito Tsuboi, Guang Hong, Shunsuke Minakuchi, Yusuke Sato, Gaku Ohwada, Tetsuya Suzuki, Katsuhiko Kimoto, Noriyuki Hoshi, Makiko Saita, Yoshikazu Yoneyama, Yohei Sato, Masakazu Morokuma, Joji Okazaki, Takeshi Maeda, Kenichiro Nakai, Tetsuo Ichikawa, Kan Nagao, Keiko Fujimoto, Hiroshi Murata, Tadafumi Kurogi, Kazuhiro Yoshida, Masahiro Nishimura, Yasuhiro Nishi, Mamoru Murakami, Toshio Hosoi, Taizo Hamada
Medicine in spine exercise (MiSpEx) for nonspecific low back pain patients: study protocol for a multicentre, single-blind randomized controlled trial
Daniel Niederer, Lutz Vogt, Pia-Maria Wippert, Anne-Katrin Puschmann, Ann-Christin Pfeifer, Marcus Schiltenwolf, Winfried Banzer, Frank Mayer
Wristband Accelerometers to motiVate arm Exercise after Stroke (WAVES): study protocol for a pilot randomized controlled trial
Sarah A. Moore, Ruth Da Silva, Madelaine Balaam, Lianne Brkic, Dan Jackson, Dan Jamieson, Thomas Ploetz, Helen Rodgers, Lisa Shaw, Frederike van Wijck, Christopher Price
BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18–30 years) exposed to a high familial breast/ovarian cancer risk: study protocol for a randomized controlled trial
Fabrice Kwiatkowski, Pascal Dessenne, Claire Laquet, Jean-Pierre Daures, Mathilde Gay-Bellile, Yves-Jean Bignon
Effects of oily fish intake on cardiovascular risk markers, cognitive function, and behavior in school-aged children: study protocol for a randomized controlled trial
Camilla T. Damsgaard, Lotte Lauritzen, Hanne Hauger, Stine Vuholm, Marie N. Teisen, Christian Ritz, Max Hansen, Janni Niclasen, Christian Mølgaard
Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30–60 years: study protocol for a randomized controlled trial
Mahnaz Ashoorkhani, Ali Bozorgi, Reza Majdzadeh, Hamed Hosseini, Ali Yoonessi, Ali Ramezankhani, Hassan Eftekhar
The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial
Ying Zhang, Jin Sun, Yun-Jiao Zhang, Qian-Yun Chai, Kang Zhang, Hong-Li Ma, Xiao-Ke Wu, Jian-Ping Liu
Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial
Feng Yang, Wen-xiong Li, Zhu Liu, Li Liu
Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial
Donna M. Urquhart, Anita E. Wluka, Malcolm R. Sim, Maurits van Tulder, Andrew Forbes, Stephen J. Gibson, Carolyn Arnold, Chris Fong, Shane N. Anthony, Flavia M. Cicuttini
A randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention compared to treatment as usual for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised controlled trial
Sonia Johnson, Luke Sheridan Rains, Steven Marwaha, John Strang, Thomas Craig, Tim Weaver, Paul McCrone, Michael King, David Fowler, Stephen Pilling, Louise Marston, Rumana Z. Omar, Meghan Craig, Mark Hinton
Postprandial effect of breakfast glycaemic index on vascular function, glycaemic control and cognitive performance (BGI study): study protocol for a randomised crossover trial
Natalia Sanchez-Aguadero, Luis Garcia-Ortiz, Maria C. Patino-Alonso, Sara Mora-Simon, Manuel A. Gomez-Marcos, Rosario Alonso-Dominguez, Benigna Sanchez-Salgado, Jose I. Recio-Rodriguez
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
Sequential Hybrid CryoMaze Ablation versus Surgical CryoMaze Alone for the Treatment of Atrial Fibrillation (SurHyb): study protocol for a randomized controlled trial
Martin Eisenberger, Alan Bulava, Josef Kautzner, Petr Neuzil, Ales Mokracek, Jiri Hanis, Ladislav Dusek
Acupuncture for the treatment of phantom limb syndrome in lower limb amputees: a randomised controlled feasibility study
Esmé G. Trevelyan, Warren A. Turner, Lynn Summerfield-Mann, Nicola Robinson
Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial
Andor F. van den Hoven, Jip F. Prince, Rutger C. G. Bruijnen, Helena M. Verkooijen, Gerard C. Krijger, Marnix G. E. H. Lam, Maurice A. A. J. van den Bosch
The effect of skin-to-skin contact at birth, early versus immediate, on the duration of exclusive human lactancy in full-term newborns treated at the Clínica Universidad de La Sabana: study protocol for a randomized clinical trial
Sergio Agudelo, Oscar Gamboa, Fabio Rodríguez, Sandra Cala, Nathalie Gualdrón, Evelyn Obando, María Lucía Padrón
Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study
Paul Hilton, Brian S. Buckley, Elaine McColl, Denise Howel, Douglas G. Tincello, Catherine Brennand
Visually-guided gait training in paretic patients during the first rehabilitation phase: study protocol for a randomized controlled trial
Cathia Rossano, Philippe Terrier
Factors associated with study attrition in a pilot randomised controlled trial to explore the role of exercise-assisted reduction to stop (EARS) smoking in disadvantaged groups
T. P. Thompson, C. J. Greaves, R. Ayres, P. Aveyard, F. C. Warren, R. Byng, R. S. Taylor, J. L. Campbell, M. Ussher, S. Michie, R. West, A. H. Taylor
Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial
Morten Fenger, Jane Lindschou, Christian Gluud, Per Winkel, Lise Jørgensen, Sten Kruse-Blinkenberg, Marianne Lau
Evolving methods to combine cognitive and physical training for individuals with mild cognitive impairment: study protocol for a randomized controlled study
Ya-yun Lee, Ching-yi Wu, Ching-hung Teng, Wen-chuin Hsu, Ku-chou Chang, Poyu Chen
High-dose intravenously administered iron versus orally administered iron in blood donors with iron deficiency: study protocol for a randomised, controlled trial
Susanne Macher, Camilla Drexler, Ines Lindenau, Nazanin Sareban, Peter Schlenke, Karin Amrein
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 Flowtow, B. Vogel, M. Werk, V. Riambau, A. Wienke, T. Lehmann, S. Sixt
Efficacy of naloxone in reducing postictal central respiratory dysfunction in patients with epilepsy: study protocol for a double-blind, randomized, placebo-controlled trial
Sylvain Rheims, Luc Valton, Véronique Michel, Louis Maillard, Vincent Navarro, Philippe Convers, Fabrice Bartolomei, Arnaud Biraben, Arielle Crespel, Philippe Derambure, Bertrand de Toffol, Edouard Hirsch, Philippe Kahane, Martine Lemesle Martin, Didier Tourniaire, Sébastien Boulogne, Catherine Mercier, Pascal Roy, Philippe Ryvlin
Comparative effects of nebivolol and carvedilol on left ventricular diastolic function in older heart failure patients with preserved ejection fraction: study protocol for a randomized controlled trial
Kyungil Park, Tae-Ho Park
Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial
Astrid Pozet, Catherine Lejeune, Magalie Bonnet, Sandrine Dabakuyo, Michèle Dion, Philippe Fagnoni, Maryse Gaimard, Geneviève Imbert, Virginie Nerich, Audrey Foubert, Morgane Chotard, Marie Bonin, Amélie Anota, Franck Bonnetain
Guided self-help interventions for mental health disorders in children with neurological conditions: study protocol for a pilot randomised controlled trial
Sophie Bennett, Isobel Heyman, Anna Coughtrey, Jess Simmonds, Sophia Varadkar, Terence Stephenson, Margaret DeJong, Roz Shafran
Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial
Túlio Eduardo Nogueira, Shahrokh Esfandiari, Cláudio Rodrigues Leles
Effects of zinc supplementation on obesity: study protocol for a randomized controlled clinical trial
Kumari M. Rathnayake, KDRR Silva, Ranil Jayawardena
Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial
Catherine Arundel, Hannah Buckley, Emma Clarke, Nicky Cullum, Stephen Dixon, Jo Dumville, Caroline Fairhurst, Anna Firth, Eileen Henderson, Karen Lamb, Elizabeth McGinnis, Angela Oswald, Pedro Saramago Goncalves, Marta Soares, Nikki Stubbs, David Torgerson, Ian Chetter
A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey
Lauren E. Kelly, Lauren M. Jansson, Wendy Moulsdale, Jodi Pereira, Sarah Simpson, Astrid Guttman, Karel Allegaert, Lisa Askie, Henry Roukema, Thierry Lacaze, Jonathan M. Davis, Loretta Finnegan, Paula Williamson, Martin Offringa
Cornerstone program for transition-age youth with serious mental illness: study protocol for a randomized controlled trial
Michelle R. Munson, Andrea Cole, Victoria Stanhope, Steven C. Marcus, Mary McKay, James Jaccard, Shelly Ben-David
Improving early childhood care and development, HIV-testing, treatment and support, and nutrition in Mokhotlong, Lesotho: study protocol for a cluster randomized controlled trial
Mark Tomlinson, Sarah Skeen, Marguerite Marlow, Lucie Cluver, Peter Cooper, Lynne Murray, Shoeshoe Mofokeng, Nathene Morley, Moroesi Makhetha, Sarah Gordon, Tonya Esterhuizen, Lorraine Sherr
Combined effect of new complete dentures and simple dietary advice on nutritional status in edentulous patients: study protocol for a randomized controlled trial
Yuriko Komagamine, Manabu Kanazawa, Maiko Iwaki, Ayami Jo, Hiroyuki Suzuki, Noriko Amagai, Shunsuke Minakuchi
Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial
Tim G. A. Calon, Marc van Hoof, Herbert van den Berge, Arthur J. G. de Bruijn, Joost van Tongeren, Janny R. Hof, Jan Wouter Brunings, Sofia Jonhede, Lucien J. C. Anteunis, Miranda Janssen, Manuela A. Joore, Marcus Holmberg, Martin L. Johansson, Robert J. Stokroos
How can we optimise inhaled beta2 agonist dose as ‘reliever’ medicine for wheezy pre-school children? Study protocol for a randomised controlled trial
Somnath Mukhopadhyay, Paul Seddon, Gemma Earl, Emma Wileman, Liz Symes, Cathy Olden, Corinne Alberti, Stephen Bremner, Alison Lansley, Colin N. A. Palmer, Nicole Beydon
Regional Anesthesia for Painful Injuries after Disasters (RAPID): study protocol for a randomized controlled trial
Adam C. Levine, Carrie Teicher, Adam R. Aluisio, Tess Wiskel, Pola Valles, Miguel Trelles, Justin Glavis-Bloom, Rebecca F. Grais
PRONTOX – proton therapy to reduce acute normal tissue toxicity in locally advanced non-small-cell lung carcinomas (NSCLC): study protocol for a randomised controlled trial
Sebastian Zschaeck, Monique Simon, Steffen Löck, Esther G. C. Troost, Kristin Stützer, Patrick Wohlfahrt, Steffen Appold, Sebastian Makocki, Rebecca Bütof, Christian Richter, Michael Baumann, Mechthild Krause
The Carotid and Middle cerebral artery Occlusion Surgery Study (CMOSS): a study protocol for a randomised controlled trial
Yan Ma, Yuxiang Gu, Xiaoguang Tong, Jiyue Wang, Dong Kuai, Donghai Wang, Jun Ren, Lian Duan, Aili Maimaiti, Yiling Cai, Yujie Huang, Xiaojian Wang, Yi Cao, Chao You, Jiasheng Yu, Liqun Jiao, Feng Ling
Development of a prognostic model based on demographic, environmental and lifestyle information for predicting incidences of symptomatic respiratory or gastrointestinal infection in adult office workers
Tapani Hovi, Jukka Ollgren, Jaason Haapakoski, Carita Savolainen-Kopra
Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial
Yan Cao, Xuan Yin, Francisca Soto-Aguilar, Yiping Liu, Ping Yin, Junyi Wu, Bochang Zhu, Wentao Li, Lixing Lao, Shifen Xu
An illness-focused interactive booklet to optimise management and medication for childhood fever and infections in out-of-hours primary care: study protocol for a cluster randomised trial
Eefje G. P. M. de Bont, Geert-Jan Dinant, Gijs Elshout, Gijs van Well, Nick A. Francis, Bjorn Winkens, Jochen W. L. Cals
A pilot and feasibility randomised controlled study of Prolonged Exposure Treatment and supportive counselling for post-traumatic stress disorder in adolescents: a third world, task-shifting, community-based sample
Jaco Rossouw, Elna Yadin, Debra Alexander, Irene Mbanga, Tracy Jacobs, Soraya Seedat
The NOURISHED randomised controlled trial comparing mentalisation-based treatment for eating disorders (MBT-ED) with specialist supportive clinical management (SSCM-ED) for patients with eating disorders and symptoms of borderline personality disorder
Paul Robinson, Jennifer Hellier, Barbara Barrett, Daiva Barzdaitiene, Anthony Bateman, Alexandra Bogaardt, Ajay Clare, Nadia Somers, Aine O’Callaghan, Kimberley Goldsmith, Nikola Kern, Ulrike Schmidt, Sara Morando, Catherine Ouellet-Courtois, Alice Roberts, Finn Skårderud, Peter Fonagy
Exceeding the recruitment target in a primary care paediatric trial: an evaluation of the Choice of Moisturiser for Eczema Treatment (COMET) feasibility randomised controlled trial
Kingsley Powell, Victoria J. Wilson, Niamh M. Redmond, Daisy M. Gaunt, Matthew J. Ridd
Integrating technology into complex intervention trial processes: a case study
Cheney J. G. Drew, Vincent Poile, Rob Trubey, Gareth Watson, Mark Kelson, Julia Townson, Anne Rosser, Kerenza Hood, Lori Quinn, Monica Busse
Recruiting to Clinical Trials on the Telephone – a randomized controlled trial
Kim Thestrup Foss, Jesper Kjærgaard, Lone Graff Stensballe, Gorm Greisen
Glycopyrrolate in comparison to hyoscine hydrobromide and placebo in the treatment of hypersalivation induced by clozapine (GOTHIC1): study protocol for a randomised controlled feasibility study
Inti Qurashi, Simon Chu, Nusrat Husain, Richard J. Drake, Imran Chaudhry, J. F. W. Deakin
Suprascapular neuropathy in the setting of rotator cuff tears: study protocol for a double-blinded randomized controlled trial
Nikolaos Platon Sachinis, Achilleas Boutsiadis, Sotirios Papagiannopoulos, Konstantinos Ditsios, Anastasios Christodoulou, Pericles Papadopoulos
Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study
Lucie A. van den Berg, Marcel G. W. Dijkgraaf, Olvert A. Berkhemer, Puck S. S. Fransen, Debbie Beumer, Hester Lingsma, Charles B. M. Majoie, Diederik W. J. Dippel, Aad J. van der Lugt, Robert J. van Oostenbrugge, Wim H. van Zwam, Yvo B. W. E. M. Roos
A trial to determine whether septic shock-reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy versus usual care (SQUEEZE): study protocol for a pilot randomized controlled trial
Melissa J. Parker, Lehana Thabane, Alison Fox-Robichaud, Patricia Liaw, Karen Choong
A metadata schema for data objects in clinical research
Steve Canham, Christian Ohmann
Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial
Clare Brittain, Margaret Childs, Lelia Duley, Jan Harding, Trish Hepburn, Garry Meakin, Alan A. Montgomery, Wei Tan, Jonathan D. C. Ross
Fitness and mobility training in patients with Intensive Care Unit-acquired muscle weakness (FITonICU): study protocol for a randomised controlled trial
Jan Mehrholz, Simone Thomas, Jane H. Burridge, André Schmidt, Bettina Scheffler, Ralph Schellin, Stefan Rückriem, Daniel Meißner, Katja Mehrholz, Wolfgang Sauter, Ulf Bodechtel, Bernhard Elsner
StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial
James E. Neffendorf, Riti Desai, Yanzhong Wang, Joanna Kelly, Caroline Murphy, Barnaby C. Reeves, Usha Chakravarthy, Sarah Wordsworth, Cornelius Lewis, Janet Peacock, Shahir Uddin, Joe M. O’Sullivan, Timothy L. Jackson
Lateral pelvic lymph node dissection after neoadjuvant chemo-radiation for preoperative enlarged lateral nodes in advanced low rectal cancer: study protocol for a randomized controlled trial
Mingtian Wei, Qingbin Wu, Chuanwen Fan, Yan Li, Xiangzheng Chen, Zongguang Zhou, Junhong Han, Ziqiang Wang
The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial
Eugene Kim, Seong Mi Yang, So Jeong Yoon, Jae-Hyon Bahk, Jeong-Hwa Seo
Adjuvant therapies in advanced hepatocellular carcinoma: moving forward from the STORM
Mohamed Bouattour, Olivier Soubrane, Armand de Gramont, Sandrine Faivre
Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial
Kristoffer Weisskirchner Barfod, Maria Swennergren Hansen, Per Holmich, Anders Troelsen, Morten Tange Kristensen
Curcumin and long-chain Omega-3 polyunsaturated fatty acids for Prevention of type 2 Diabetes (COP-D): study protocol for a randomised controlled trial
Rohith N. Thota, Shamasunder H. Acharya, Kylie A. Abbott, Manohar L. Garg
Design of case report forms based on a public metadata registry: re-use of data elements to improve compatibility of data
Martin Dugas
Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial
Edgard Silva Garcia, Daniela Francescato Veiga, Joel Veiga-Filho, Isaías Vieira Cabral, Natália Lana Larcher Pinto, Neil Ferreira Novo, Miguel Sabino Neto, Lydia Masako Ferreira
START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised 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
Tonic and burst spinal cord stimulation waveforms for the treatment of chronic, intractable pain: study protocol for a randomized controlled trial
Konstantin V. Slavin, Richard B. North, Timothy R. Deer, Peter Staats, Kristina Davis, Roni Diaz
The effects of computer-based mindfulness training on Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains in a healthy student population (SMASH): study protocol for a randomized controlled trial
Zarah Rowland, Mario Wenzel, Thomas Kubiak
Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial
Lene Maria Ørts, Anders Løkke, Anne-Louise Bjerregaard, Helle Terkildsen Maindal, Annelli Sandbæk
Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial
Maurizio Gasparini, Paola Galimberti, Renato Bragato, Stefano Ghio, Claudia Raineri, Maurizio Landolina, Enrico Chieffo, Maurizio Lunati, Ederina Mulargia, Alessandro Proclemer, Domenico Facchin, Roberto Rordorf, Alessandro Vicentini, Lina Marcantoni, Francesco Zanon, Catherine Klersy
Effectiveness of enhanced cognitive behavioral therapy (CBT-E) for eating disorders: study protocol for a randomized controlled trial
Martie de Jong, Kees Korrelboom, Iris van der Meer, Mathijs Deen, Hans W. Hoek, Philip Spinhoven
A randomised, patient-assessor blinded, sham-controlled trial of external non-invasive peripheral nerve stimulation for chronic neuropathic pain following peripheral nerve injury (EN-PENS trial): study protocol for a randomised controlled trial
Selina Johnson, Roberta Richey, Emily Holmes, Dyfrig Hughes, Andreas Goebel
The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality
Sarah J. Arnup, Andrew B. Forbes, Brennan C. Kahan, Katy E. Morgan, Joanne E. McKenzie
Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial
Katherine E. A. Semrau, Lisa R. Hirschhorn, Bhala Kodkany, Jonathan M. Spector, Danielle E. Tuller, Gary King, Stuart Lipsitz, Narender Sharma, Vinay Pratap Singh, Bharath Kumar, Neelam Dhingra-Kumar, Rebecca Firestone, Vishwajeet Kumar, Atul A. Gawande
NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung’s disease treatment
Benjamin Allin, Timothy Bradnock, Simon Kenny, Gregor Walker, Marian Knight
The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery – AIR: study protocol for a randomised controlled trial
Svajunas Statkevicius, Johan Bonnevier, Björn P. Bark, Erik Larsson, Carl M. Öberg, Päivi Kannisto, Bobby Tingstedt, Peter Bentzer
The RAPID-CTCA trial (Rapid Assessment of Potential Ischaemic Heart Disease with CTCA) — a multicentre parallel-group randomised trial to compare early computerised tomography coronary angiography versus standard care in patients presenting with suspected or confirmed acute coronary syndrome: study protocol for a randomised controlled trial
Alasdair J. Gray, Carl Roobottom, Jason E. Smith, Steve Goodacre, Katherine Oatey, Rachel O’Brien, Robert F. Storey, Lumine Na, Steff C. Lewis, Praveen Thokala, David E. Newby
What is the impact of obtaining medical clearance to participate in a randomised controlled trial examining a physical activity intervention on the socio-demographic and risk factor profiles of included participants?
Mitch J. Duncan, Richard R. Rosenkranz, Corneel Vandelanotte, Cristina M. Caperchione, Amanda L. Rebar, Anthony J. Maeder, Rhys Tague, Trevor N. Savage, Anetta van Itallie, W. Kerry Mummery, Gregory S. Kolt
The citation of relevant systematic reviews and randomised trials in published reports of trial protocols
Nikolaos Pandis, Padhraig S. Fleming, Despina Koletsi, Sally Hopewell
The Radical Extent of lymphadenectomy — D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial
Jun-Yang Lu, Lai Xu, Hua-Dan Xue, Wei-Xun Zhou, Tao Xu, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Yi Xiao
Feasibility of an online intervention (STAK-D) to promote physical activity in children with type 1 diabetes: protocol for a randomised controlled trial
Holly Blake, Helen Quirk, Paul Leighton, Tabitha Randell, James Greening, Boliang Guo, Cris Glazebrook
Achieving Good Outcomes for Asthma Living (GOAL): mixed methods feasibility and pilot cluster randomised controlled trial of a practical intervention for eliciting, setting and achieving goals for adults with asthma
Gaylor Hoskins, Brian Williams, Purva Abhyankar, Peter Donnan, Edward Duncan, Hilary Pinnock, Marjon van der Pol, Petra Rauchhaus, Anne Taylor, Aziz Sheikh
Tailored approach to sleep health education (TASHE): study protocol for a web-based randomized controlled trial
Natasha J. Williams, Rebecca Robbins, David Rapoport, John P. Allegrante, Alwyn Cohall, Gbenga Ogedgebe, Girardin Jean-Louis
The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial
Adwoa Hughes-Morley, Mark Hann, Claire Fraser, Oonagh Meade, Karina Lovell, Bridget Young, Chris Roberts, Lindsey Cree, Donna More, Neil O’Leary, Patrick Callaghan, Waquas Waheed, Peter Bower
Abdominal Septic Shock – Endotoxin Adsorption Treatment (ASSET) – endotoxin removal in abdominal and urogenital septic shock with the Alteco® LPS Adsorber: study protocol for a double-blinded, randomized placebo-controlled trial
Miklos Lipcsey, Jyrki Tenhunen, Jan Sjölin, Robert Frithiof, Stepani Bendel, Hans Flaatten, Rafael Kawati, Anne Kuitunen, Tor Inge Tønnessen, Sten Rubertsson
Effectiveness of a girls’ empowerment programme on early childbearing, marriage and school dropout among adolescent girls in rural Zambia: study protocol for a cluster randomized trial
Ingvild Fossgard Sandøy, Mweetwa Mudenda, Joseph Zulu, Ecloss Munsaka, Astrid Blystad, Mpundu C. Makasa, Ottar Mæstad, Bertil Tungodden, Choolwe Jacobs, Linda Kampata, Knut Fylkesnes, Joar Svanemyr, Karen Marie Moland, Richard Banda, Patrick Musonda
The magnitude and temporal changes of response in the placebo arm of surgical randomized controlled trials: a systematic review and meta-analysis
Karolina A. Wartolowska, Benjamin G. Feakins, Gary S. Collins, Jonathan Cook, Andrew Judge, Ines Rombach, Benjamin J. F. Dean, James A. Smith, Andrew J. Carr
Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial
Simon Lebech Cichosz, Lars Holger Ehlers, Ole Hejlesen
The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial
Matthew Wilson, Christine MacArthur, Fang Gao Smith, Leanne Homer, Kelly Handley, Jane Daniels, Linda Bradley, Seetharama Dinesh, Teresa Melody, Cody Allen, Karen Davies, Jennie Kerr, Philip Moore, Diane Whitehouse, Rebecca Chana, Deborah Horner, Aongola Ngenda, Jennifer Syson, Lesley Brittain, Kodaganallur Krishnan, Sarah Potter, Sarah Armstrong, Alexandra Oatley, Carol Snipe, Sandur Naresh, Sarah Davenport, Laurie Deeks, Sebastian Murray, Priya Krishnan, Maines Msiska, Jeremy Corfe, Elizabeth Turner, Elaine Johnson, Nuala Lucas, Jules Allt, Anna Fleming, Amanda Redford, Maria Okoisor, Julie Tebbutt, Jane Hillen, Angela Polanco, Megha Reddy, Zoe D’Souza, Anna Guy, Peter Rose, Holly Alcock, Samantha Roche, Suzanne Taylor
The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial
David H. Gustafson Sr, Gina Landucci, Fiona McTavish, Rachel Kornfield, Roberta A. Johnson, Marie-Louise Mares, Ryan P. Westergaard, Andrew Quanbeck, Esra Alagoz, Klaren Pe-Romashko, Chantelle Thomas, Dhavan Shah
Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial
Laila Kristoffersen, Ragnhild Støen, Hilde Rygh, Margunn Sognnæs, Turid Follestad, Hilde S. Mohn, Ingrid Nissen, Håkon Bergseng
‘Walk This Way’ – a pilot of a health coaching intervention to reduce sedentary behaviour and increase low intensity exercise in people with serious mental illness: study protocol for a randomised controlled trial
Julie Williams, Brendon Stubbs, Fiona Gaughran, Tom Craig
Using re-randomization to increase the recruitment rate in clinical trials – an assessment of three clinical areas
Brennan C. Kahan
Impact of communication strategies to increase knowledge, acceptability, and uptake of a new Woman’s Condom in urban Lusaka, Zambia: study protocol for a randomized controlled trial
Jessie Pinchoff, Rachna Nag Chowdhuri, Noah Taruberekera, Thoai D. Ngo
Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial
Ling Cui, Yu Shi, GN Zhang
Increasing engagement with, and effectiveness of, an online CBT-based stress management intervention for employees through the use of an online facilitated bulletin board: study protocol for a pilot randomised controlled trial
Stephany Carolan, Peter R. Harris, Kathryn Greenwood, Kate Cavanagh
Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children
Siobhan Creanor, Jenny Lloyd, Melvyn Hillsdon, Sarah Dean, Colin Green, Rod S. Taylor, Emma Ryan, Katrina Wyatt
The effect of community groups and mobile phone messages on the prevention and control of diabetes in rural Bangladesh: study protocol for a three-arm cluster randomised controlled trial
Edward Fottrell, Hannah Jennings, Abdul Kuddus, Naveed Ahmed, Joanna Morrison, Kohenour Akter, Sanjit Kumar Shaha, Badrun Nahar, Tasmin Nahar, Hassan Haghparast-Bidgoli, A. K. Azad Khan, Anthony Costello, Kishwar Azad
The incidence of training responsiveness to cardiorespiratory fitness and cardiometabolic measurements following individualized and standardized exercise prescription: study protocol for a randomized controlled trial
Ryan M. Weatherwax, Nigel K. Harris, Andrew E. Kilding, Lance C. Dalleck
Fostering Effective Early Learning (FEEL) through a professional development programme for early childhood educators to improve professional practice and child outcomes in the year before formal schooling: study protocol for a cluster randomised controlled trial
Edward Melhuish, Steven J. Howard, Iram Siraj, Cathrine Neilsen-Hewett, Denise Kingston, Marc de Rosnay, Elisabeth Duursma, Betty Luu
Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): study protocol for a randomized controlled trial
Andrew McWilliams, Jason Roberge, Charity G. Moore, Avery Ashby, Whitney Rossman, Stephanie Murphy, Stephannie McCall, Ryan Brown, Shannon Carpenter, Scott Rissmiller, Scott Furney
Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial
Sarah Brown, Isabelle L. Smith, Julia M. Brown, Claire Hulme, Elizabeth McGinnis, Nikki Stubbs, E. Andrea Nelson, Delia Muir, Claudia Rutherford, Kay Walker, Valerie Henderson, Lyn Wilson, Rachael Gilberts, Howard Collier, Catherine Fernandez, Suzanne Hartley, Moninder Bhogal, Susanne Coleman, Jane E. Nixon
Erratum to: Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial
Laura Sheard, Jane O’Hara, Gerry Armitage, John Wright, Kim Cocks, Rosemary McEachan, Ian Watt, Rebecca Lawton
A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial
Allison G. Harvey, Kerrie Hein, Lu Dong, Freddie L. Smith, Michael Lisman, Stephanie Yu, Sophia Rabe-Hesketh, Daniel J. Buysse
A survey of facilitators and barriers to recruitment to the MAGNETIC trial
Geetinder Kaur, Rosalind L. Smyth, Colin V. E. Powell, Paula Williamson
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, Andrew Pickles, Emily Robinson, Tim Smith, Edmund J. S. Sonuga-Barke, Sam Wass, Mark H. Johnson
Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial
Cezar Giosan, Oana Cobeanu, Cristina Mogoaşe, Aurora Szentágotai Tătar, Vlad Mureşan, Rareș Boian