Ausgabe 1/2014
Inhalt (514 Artikel)
A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study - Alimentation and Diabetes in Lanzarote -ADILAN
Maelán Fontes-Villalba, Tommy Jönsson, Yvonne Granfeldt, Lynda A Frassetto, Jan Sundquist, Kristina Sundquist, Pedro Carrera-Bastos, María Fika-Hernándo, Óscar Picazo, Staffan Lindeberg
The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol
Michael D Jenkinson, Carrol Gamble, John C Hartley, Helen Hickey, Dyfrig Hughes, Michaela Blundell, Michael J Griffiths, Tom Solomon, Conor L Mallucci
Clear obstacles and hidden challenges: understanding recruiter perspectives in six pragmatic randomised controlled trials
Jenny L Donovan, Sangeetha Paramasivan, Isabel de Salis, Merran Toerien
The effect of antihypertensive agents on sleep apnea: protocol for a randomized controlled trial
Fábio Tremea Cichelero, Denis Martinez, Sandra Costa Fuchs, Miguel Gus, Leila Beltrami Moreira, Flávio Danni Fuchs
The efficacy of dexamethasone on reduction in the reoperation rate of chronic subdural hematoma – the DRESH study: straightforward study protocol for a randomized controlled trial
Stephan Emich, Bernd Richling, Marc R McCoy, Rahman Abdul Al-Schameri, Feng Ling, Liyong Sun, Yabing Wang, Wolfgang Hitzl
Effectiveness of two physical therapy interventions, relative to dental treatment in individuals with bruxism: study protocol of a randomized clinical trial
Cinthia Santos Miotto Amorim, Eliete Ferreira Osses Firsoff, Glauco Fioranelli Vieira, Jecilene Rosana Costa, Amélia Pasqual Marques
The face of equipoise - delivering a structured education programme within a randomized controlled trial: qualitative study
Helen C Eborall, Helen M Dallosso, Heather Daly, Lorraine Martin-Stacey, Simon R Heller
Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial
Dawn Kingston, Sheila McDonald, Anne Biringer, Marie-Paule Austin, Kathy Hegadoren, Sarah McDonald, Rebecca Giallo, Arto Ohinmaa, Gerri Lasiuk, Glenda MacQueen, Wendy Sword, Marie Lane-Smith, Sander Veldhuyzen van Zanten
Acetaminophen for self-reported sleep problems in an elderly population (ASLEEP): study protocol of a randomized placebo-controlled double-blind trial
Esther MM van de Glind, Lotty Hooft, Linda R Tulner, Joke HM Tulen, Ingeborg MJA Kuper, Hans L Hamburger, Sophia E de Rooij, Barbara C van Munster
The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial
Cameron Lindsay, Julie Simpson, Sissi Ispoglou, Steve G Sturman, Anand D Pandyan
Advance telephone calls ahead of reminder questionnaires increase response rate in non-responders compared to questionnaire reminders only: The RECORD phone trial
Graeme MacLennan, Alison McDonald, Gladys McPherson, Shaun Treweek, Alison Avenell
A randomised controlled trial of the clinical effectiveness, safety and cost-effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis (SYCAMORE Trial)
Athimalaipet V Ramanan, Andrew D Dick, Diana Benton, Sandrine Compeyrot-Lacassagne, Dalia Dawoud, Ben Hardwick, Helen Hickey, Dyfrig Hughes, Ashley Jones, Patricia Woo, Clive Edelsten, Michael W Beresford
A European inventory of common electronic health record data elements for clinical trial feasibility
Justin Doods, Florence Botteri, Martin Dugas, Fleur Fritz
Electroacupuncture for pressure ulcer: a study protocol for a randomized controlled pilot trial
Qin-hong Zhang, Jin-huan Yue, Zhong-ren Sun
Funding source and the quality of reports of chronic wounds trials: 2004 to 2011
Robert Hodgson, Richard Allen, Ellen Broderick, J Martin Bland, Jo C Dumville, Rebecca Ashby, Sally Bell-Syer, Ruth Foxlee, Jill Hall, Karen Lamb, Mary Madden, Susan O’Meara, Nikki Stubbs, Nicky Cullum
Reporting of interventions in randomised trials: an audit of journal Instructions to Authors
Tammy Hoffmann, Thomas English, Paul Glasziou
Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–INTRANS: study protocol for a randomized controlled trial
Katja Maschuw, Christine Heinz, Elisabeth Maurer, Alexander Reuss, Carmen Schade-Brittinger, Detlef Klaus Bartsch
Tailored interventions to implement recommendations for elderly patients with depression in primary care: a study protocol for a pragmatic cluster randomised controlled trial
Eivind Aakhus, Ingeborg Granlund, Jan Odgaard-Jensen, Michel Wensing, Andrew D Oxman, Signe A Flottorp
Changing case Order to Optimise patterns of Performance in mammography Screening (CO-OPS): study protocol for a randomized controlled trial
Sian Taylor-Phillips, Matthew G Wallis, Helen Parsons, Janet Dunn, Nigel Stallard, Helen Campbell, Sarah Sellars, Ala Szczepura, Simon Gates, Aileen Clarke
The effect of febuxostat to prevent a further reduction in renal function of patients with hyperuricemia who have never had gout and are complicated by chronic kidney disease stage 3: study protocol for a multicenter randomized controlled study
Tatsuo Hosoya, Kenjiro Kimura, Sadayoshi Itoh, Masaaki Inaba, Shunya Uchida, Yasuhiko Tomino, Hirofumi Makino, Seiichi Matsuo, Tetsuya Yamamoto, Iwao Ohno, Yugo Shibagaki, Satoshi Iimuro, Naohiko Imai, Masanari Kuwabara, Hiroshi Hayakawa
Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial
Angela O’Dea, Jennifer J Infanti, Paddy Gillespie, Olga Tummon, Samuel Fanous, Liam G Glynn, Brian E McGuire, John Newell, Fidelma P Dunne
Recruitment and retention of young women into nutrition research studies: practical considerations
Alecia Leonard, Melinda Hutchesson, Amanda Patterson, Kerry Chalmers, Clare Collins
A cross-sectional analysis of HIV and hepatitis C clinical trials 2007 to 2010: the relationship between industry sponsorship and randomized study design
Neela D Goswami, Ephraim L Tsalik, Susanna Naggie, William C Miller, John R Horton, Christopher D Pfeiffer, Charles B Hicks
Methodological survey of designed uneven randomization trials (DU-RANDOM): a protocol
Darong Wu, Elie A Akl, Gordon H Guyatt, Philip J Devereaux, Romina Brignardello-Petersen, Barbara Prediger, Krupesh Patel, Namrata Patel, Taoying Lu, Yuan Zhang, Maicon Falavigna, Nancy Santesso, Reem A Mustafa, Qi Zhou, Matthias Briel, Holger J Schünemann
SMS reminders to improve the tuberculosis cure rate in developing countries (TB-SMS Cameroon): a protocol of a randomised control study
Georges Bediang, Beat Stoll, Nadia Elia, Jean-Louis Abena, Désiré Nolna, Philippe Chastonay, Antoine Geissbuhler
Cognitive behavioral therapy for insomnia in euthymic bipolar disorder: study protocol for a randomized controlled trial
Mette Kvisten Steinan, Karoline Krane-Gartiser, Knut Langsrud, Trond Sand, Håvard Kallestad, Gunnar Morken
LOCAT (low-dose computed tomography for appendicitis trial) comparing clinical outcomes following low- vs standard-dose computed tomography as the first-line imaging test in adolescents and young adults with suspected acute appendicitis: study protocol for a randomized controlled trial
Soyeon Ahn
Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial
Shelley Rhodes, David A Richards, David Ekers, Dean McMillan, Sarah Byford, Paul A Farrand, Simon Gilbody, Steven D Hollon, Willem Kuyken, Christopher Martell, Heather A O’Mahen, Emer O’Neill, Nigel Reed, Rod S Taylor, Ed R Watkins, Kim A Wright
Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial
Karen L Barker, Muhammad K Javaid, Meredith Newman, Catherine Minns Lowe, Nigel Stallard, Helen Campbell, Varsha Gandhi, Sallie Lamb
The trials methodological research agenda: results from a priority setting exercise
Catrin Tudur Smith, Helen Hickey, Mike Clarke, Jane Blazeby, Paula Williamson
Can a combined screening/treatment programme prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies: study protocol for the multicentre randomised controlled OuTSMART trial
Anthony Dorling, Irene Rebollo-Mesa, Rachel Hilton, Janet L Peacock, Robert Vaughan, Leanne Gardner, Guilherme Danzi, Richard Baker, Brendan Clark, Raj C Thuraisingham, Matthew Buckland, Michael Picton, Susan Martin, Richard Borrows, David Briggs, Robert Horne, Paul McCrone, Joanna Kelly, Caroline Murphy
Effectiveness and cost-effectiveness of a telehealth intervention to support the management of long-term conditions: study protocol for two linked randomized controlled trials
Clare L Thomas, Mei-See Man, Alicia O’Cathain, Sandra Hollinghurst, Shirley Large, Louisa Edwards, Jon Nicholl, Alan A Montgomery, Chris Salisbury
Tai Chi-based exercise program provided via telerehabilitation compared to home visits in a post-stroke population who have returned home without intensive rehabilitation: study protocol for a randomized, non-inferiority clinical trial
Michel Tousignant, Hélène Corriveau, Dahlia Kairy, Katherine Berg, Marie-France Dubois, Sylvie Gosselin, Richard H Swartz, Jean-Martin Boulanger, Cynthia Danells
Targeted rehabilitation to improve outcome after total knee replacement (TRIO): study protocol for a randomised controlled trial
A Hamish RW Simpson, David F Hamilton, David J Beard, Karen L Barker, Timothy Wilton, James D Hutchison, Chris Tuck, Andrew Stoddard, Gary J Macfarlane, Gordon D Murray
An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes - the MID-Frail study: study protocol for a randomised controlled trial
Leocadio Rodríguez-Mañas, Antony J Bayer, Mark Kelly, Andrej Zeyfang, Mikel Izquierdo, Olga Laosa, Timothy C Hardman, Alan J Sinclair
GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial
David Daniel Ebert, Dirk Lehr, Harald Baumeister, Leif Boß, Heleen Riper, Pim Cuijpers, Jo Annika Reins, Claudia Buntrock, Matthias Berking
CANABIC: CANnabis and Adolescents: effect of a Brief Intervention on their Consumption – study protocol for a randomized controlled trial
Catherine Laporte, Hélène Vaillant-Roussel, Bruno Pereira, Olivier Blanc, Gilles Tanguy, Paul Frappé, David Costa, Yoann Gaboreau, Mélanie Badin, Laurent Marty, Gilles Clément, Claude Dubray, Bruno Falissard, Pierre-Michel Llorca, Philippe Vorilhon
Developing core outcomes sets: methods for identifying and including patient-reported outcomes (PROs)
Rhiannon C Macefield, Marc Jacobs, Ida J Korfage, Joanna Nicklin, Robert N Whistance, Sara T Brookes, Mirjam AG Sprangers, Jane M Blazeby
Physical fitness training in Subacute Stroke (PHYS-STROKE) - study protocol for a randomised controlled trial
Agnes Flöel, Cordula Werner, Ulrike Grittner, Stefan Hesse, Michael Jöbges, Janet Knauss, Michael Seifert, Elisabeth Steinhagen-Thiessen, Mehmet Gövercin, Christian Dohle, Wolfgang Fischer, Regina Schlieder, Alexander Heinrich Nave, Andreas Meisel, Martin Ebinger, Ian Wellwood
Movement as Medicine for Type 2 Diabetes: protocol for an open pilot study and external pilot clustered randomised controlled trial to assess acceptability, feasibility and fidelity of a multifaceted behavioural intervention targeting physical activity in primary care
Leah Avery, Falko F Sniehotta, Sarah J Denton, Nick Steen, Elaine McColl, Roy Taylor, Michael I Trenell
Acupuncture for chronic, stable angina pectoris and an investigation of the characteristics of acupoint specificity: study protocol for a multicenter randomized controlled trial
Dehua Li, Mingxiao Yang, Ling Zhao, Hui Zheng, Ying Li, Xiaorong Chang, Jin Cui, Ruihui Wang, Jing Shi, Junling Lv, Junyan Leng, Juan Li, Fanrong Liang
Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries
Monica Taljaard, Jamie C Brehaut, Charles Weijer, Robert Boruch, Allan Donner, Martin P Eccles, Andrew D McRae, Raphael Saginur, Merrick Zwarenstein, Jeremy M Grimshaw
Pilot trial of Stop Delirium! (PiTStop) - a complex intervention to prevent delirium in care homes for older people: study protocol for a cluster randomised controlled trial
Anne Heaven, Francine Cheater, Andrew Clegg, Michelle Collinson, Amanda Farrin, Anne Forster, Mary Godfrey, Liz Graham, Anne Grice, Rachel Holt, Claire Hulme, Ernie Lloyd, David Meads, Chris North, John Young, Najma Siddiqi
Feasibility, double-blind, randomised, placebo-controlled, multi-centre trial of hand-held NB-UVB phototherapy for the treatment of vitiligo at home (HI-Light trial: Home Intervention of Light therapy)
Viktoria Eleftheriadou, Kim Thomas, Jane Ravenscroft, Maxine Whitton, Jonathan Batchelor, Hywel Williams
Effectiveness of adolescent suicide prevention e-learning modules that aim to improve knowledge and self-confidence of gatekeepers: study protocol for a randomized controlled trial
Rezvan Ghoncheh, Ad JFM Kerkhof, Hans M Koot
Aggregated n-of-1 trials of central nervous system stimulants versus placebo for paediatric traumatic brain injury – a pilot study
Catherine J Nikles, Lynne McKinlay, Geoffrey K Mitchell, Sue-Ann S Carmont, Hugh E Senior, Mary-Clare A Waugh, Adrienne Epps, Philip J Schluter, Owen T Lloyd
The GoodNight study—online CBT for insomnia for the indicated prevention of depression: study protocol for a randomised controlled trial
John A Gosling, Nick Glozier, Kathleen Griffiths, Lee Ritterband, Frances Thorndike, Andrew Mackinnon, Kanupriya Kalia Hehir, Anthony Bennett, Kylie Bennett, Helen Christensen
A primary-school-based study to reduce the prevalence of childhood obesity – the EdAl (Educació en Alimentació) study: a randomized controlled trial
Lucia Tarro, Elisabet Llauradó, Rosa Albaladejo, David Moriña, Victoria Arija, Rosa Solà, Montse Giralt
Daily interruption of sedation in critically ill children: study protocol for a randomized controlled trial
Nienke J Vet, Saskia N de Wildt, Carin WM Verlaat, Catherijne AJ Knibbe, Miriam G Mooij, Wim CJ Hop, Joost van Rosmalen, Dick Tibboel, Matthijs de Hoog
HPTN 071 (PopART): Rationale and design of a cluster-randomised trial of the population impact of an HIV combination prevention intervention including universal testing and treatment – a study protocol for a cluster randomised trial
Richard Hayes, Helen Ayles, Nulda Beyers, Kalpana Sabapathy, Sian Floyd, Kwame Shanaube, Peter Bock, Sam Griffith, Ayana Moore, Deborah Watson-Jones, Christophe Fraser, Sten H Vermund, Sarah Fidler
Coping with Persistent Pain, Effectiveness Research into Self-management (COPERS): statistical analysis plan for a randomised controlled trial
Brennan C Kahan, Karla Diaz-Ordaz, Kate Homer, Dawn Carnes, Martin Underwood, Stephanie JC Taylor, Stephen A Bremner, Sandra Eldridge
Fluoxetine in Progressive Multiple Sclerosis (FLUOX-PMS): study protocol for a randomized controlled trial
Melissa Cambron, Jop Mostert, Patrick Haentjens, Marie D’Hooghe, Guy Nagels, Barbara Willekens, Dorothea Heersema, Jan Debruyne, Wim Van Hecke, Luc Algoed, Nina De Klippel, Erwin Fosselle, Guy Laureys, Henri Merckx, Bart Van Wijmeersch, Ludo Vanopdenbosch, Wim Verhagen, Raymond Hupperts, Gerald Hengstman, Veronique Michiels, Annick Van Merhaegen-Wieleman, Jacques De Keyser
Health services changes: is a run-in period necessary before evaluation in randomised clinical trials?
Trishna Rathod, John Belcher, Alan A Montgomery, Chris Salisbury, Nadine E Foster
A smartphone intervention for adolescent obesity: study protocol for a randomised controlled non-inferiority trial
Grace O’Malley, Mike Clarke, Amanda Burls, Sinéad Murphy, Nuala Murphy, Ivan J Perry
Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation
Katie Gillies, Wan Huang, Zoë Skea, Jamie Brehaut, Seonaidh Cotton
IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial
Thomas Zeller, Iris Baumgartner, Dierk Scheinert, Marianne Brodmann, Marc Bosiers, Antonio Micari, Patrick Peeters, Frank Vermassen, Mario Landini
Uthando Lwethu (‘our love’): a protocol for a couples-based intervention to increase testing for HIV: a randomized controlled trial in rural KwaZulu-Natal, South Africa
Lynae A Darbes, Heidi van Rooyen, Victoria Hosegood, Thulani Ngubane, Mallory O Johnson, Katherine Fritz, Nuala McGrath
The drooling reduction intervention trial (DRI): a single blind trial comparing the efficacy of glycopyrronium and hyoscine on drooling in children with neurodisability
Jeremy R Parr, Emma Weldon, Lindsay Pennington, Nick Steen, Jane Williams, Charlie Fairhurst, Anne O’Hare, Raj Lodh, Allan Colver
A pilot study to evaluate the efficacy of adding a structured home visiting intervention to improve outcomes for high-risk families attending the Incredible Years Parent Programme: study protocol for a randomised controlled trial
Dianne G Lees, David M Fergusson, Christopher M Frampton, Sally N Merry
Study protocol for a comparative effectiveness trial of two parent training programs in a fee-for-service mental health clinic: can we improve mental health services to low-income families?
Deborah A Gross, Harolyn ME Belcher, Mirian E Ofonedu, Susan Breitenstein, Kevin D Frick, Chakra Budhathoki
The By-Band study: gastric bypass or adjustable gastric band surgery to treat morbid obesity: study protocol for a multi-centre randomised controlled trial with an internal pilot phase
Chris A Rogers, Richard Welbourn, James Byrne, Jenny L Donovan, Barnaby C Reeves, Sarah Wordsworth, Robert Andrews, Janice L Thompson, Paul Roderick, David Mahon, Hamish Noble, Jamie Kelly, Graziella Mazza, Katie Pike, Sangeetha Paramasivan, Natalie Blencowe, Mary Perkins, Tanya Porter, Jane M Blazeby
Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design
Laura Richert, Adélaïde Doussau, Jean-Daniel Lelièvre, Vincent Arnold, Véronique Rieux, Amel Bouakane, Yves Lévy, Geneviève Chêne, Rodolphe Thiébaut
Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial
Robert B Saper, Karen J Sherman, Anthony Delitto, Patricia M Herman, Joel Stevans, Ruth Paris, Julia E Keosaian, Christian J Cerrada, Chelsey M Lemaster, Carol Faulkner, Maya Breuer, Janice Weinberg
An investigation of the impact of futility analysis in publicly funded trials
Benjamin GO Sully, Steven A Julious, Jon Nicholl
What is the ideal dose and power output of low-level laser therapy (810 nm) on muscle performance and post-exercise recovery? Study protocol for a double-blind, randomized, placebo-controlled trial
Adriano Rodrigues de Oliveira, Adriane Aver Vanin, Thiago De Marchi, Fernanda Colella Antonialli, Vanessa dos Santos Grandinetti, Paulo Roberto Vicente de Paiva, Gianna Móes Albuquerque Pontes, Larissa Aline Santos, Ivo de Oliveira Aleixo Junior, Paulo de Tarso Camillo de Carvalho, Jan Magnus Bjordal, Ernesto Cesar Pinto Leal-Junior
Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya
Vibian Angwenyi, Dorcas Kamuya, Dorothy Mwachiro, Betty Kalama, Vicki Marsh, Patricia Njuguna, Sassy Molyneux
Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol
Leila Pfaeffli Dale, Robyn Whittaker, Yannan Jiang, Ralph Stewart, Anna Rolleston, Ralph Maddison
Predicting clinical trial results based on announcements of interim analyses
Kristine R Broglio, David N Stivers, Donald A Berry
Self-management in early-stage dementia: a pilot randomised controlled trial of the efficacy and cost-effectiveness of a self-management group intervention (the SMART study)
Catherine Quinn, Daniel Anderson, Gill Toms, Rhiannon Whitaker, Rhiannon Tudor Edwards, Carys Jones, Linda Clare
Evaluation of a tailored intervention to improve management of overweight and obesity in primary care: study protocol of a cluster randomised controlled trial
Jane Krause, Shona Agarwal, Danielle H Bodicoat, Arne Ring, David Shepherd, Stephen Rogers, Michel Wensing, Richard Baker
Lack of timely accrual information in oncology clinical trials: a cross-sectional analysis
Aaron P Mitchell, Bradford R Hirsch, Amy P Abernethy
Exploring recruitment barriers and facilitators in early cancer detection trials: the use of pre-trial focus groups
Roshan das Nair, Kate Skellington Orr, Kavita Vedhara, Denise Kendrick
Consumption of whole grains and legumes modulates the genetic effect of the APOA5 -1131C variant on changes in triglyceride and apolipoprotein A-V concentrations in patients with impaired fasting glucose or newly diagnosed type 2 diabetes
Ryungwoo Kang, Minjoo Kim, Jey Sook Chae, Sang-Hyun Lee, Jong Ho Lee
CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures
Thomas Nusselt, Alexander Hofmann, Daniel Wachtlin, Stanislav Gorbulev, Pol Maria Rommens
Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study
Shelley Potter, Nicola Mills, Simon J Cawthorn, Jenny Donovan, Jane M Blazeby
Comparing high altitude treatment with current best care in Dutch children with moderate to severe atopic dermatitis (and asthma): study protocol for a pragmatic randomized controlled trial (DAVOS trial)
Karin B Fieten, Wieneke T Zijlstra, Harmieke van Os-Medendorp, Yolanda Meijer, Monica Uniken Venema, Lous Rijssenbeek-Nouwens, Monique P l’Hoir, Carla A Bruijnzeel-Koomen, Suzanne GMA Pasmans
Effect of eccentric isokinetic strengthening in the rehabilitation of patients with knee osteoarthritis: Isogo, a randomized trial
Anne-Gaëlle Jegu, Bruno Pereira, Nicolas Andant, Emmanuel Coudeyre
Launching a salt substitute to reduce blood pressure at the population level: a cluster randomized stepped wedge trial in Peru
Antonio Bernabe-Ortiz, Francisco Diez-Canseco, Robert H Gilman, María K Cárdenas, Katherine A Sacksteder, J Jaime Miranda
Antioxidant-rich dietary intervention for improving asthma control in pregnancies complicated by asthma: study protocol for a randomized controlled trial
Jessica A Grieger, Lisa G Wood, Vicki L Clifton
Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial
Daniele Regge, Gabriella Iussich, Carlo Senore, Loredana Correale, Cesare Hassan, Alberto Bert, Stefania Montemezzi, Nereo Segnan
The Stroke Oxygen Study (SO2S) - a multi-center study to assess whether routine oxygen treatment in the first 72 hours after a stroke improves long-term outcome: study protocol for a randomized controlled trial
Christine Roffe, Tracy Nevatte, Peter Crome, Richard Gray, Julius Sim, Sarah Pountain, Linda Handy, Peter Handy
HEPBURN - investigating the efficacy and safety of nebulized heparin versus placebo in burn patients with inhalation trauma: study protocol for a multi-center randomized controlled trial
Gerie J Glas, Johannes Muller, Jan M Binnekade, Berry Cleffken, Kirsten Colpaert, Barry Dixon, Nicole P Juffermans, Paul Knape, Marcel M Levi, Bert G Loef, David P Mackie, Manu Malbrain, Marcus J Schultz, Koenraad F van der Sluijs
The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials
Vikram Patel, Benedict Weobong, Abhijit Nadkarni, Helen A Weiss, Arpita Anand, Smita Naik, Bhargav Bhat, Jesina Pereira, Ricardo Araya, Sona Dimidjian, Steven D Hollon, Michael King, Jim McCambridge, David McDaid, Pratima Murthy, Richard Velleman, Christopher G Fairburn, Betty Kirkwood
Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care – study protocol for a randomized clinical trial
Andreas Eklund, Iben Axén, Alice Kongsted, Malin Lohela-Karlsson, Charlotte Leboeuf-Yde, Irene Jensen
Improving clinical trial efficiency by biomarker-guided patient selection
Ruud Boessen, Hiddo J Lambers Heerspink, Dick De Zeeuw, Diederick E Grobbee, Rolf HH Groenwold, Kit CB Roes
Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial
Xue-Qiang Wang, Yan-Lin Pi, Pei-Jie Chen, Bin-Lin Chen, Lei-Chao Liang, Xin Li, Xiao Wang, Juan Zhang
FAIRY: a randomized controlled patient-blind phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose (Ferinject®) to placebo in patients with acute isovolemic anemia after gastrectomy - study protocol for a randomized controlled trial
Daniel Reim, Young-Woo Kim, Byung Ho Nam, Mi-Jung Kim, Jeong Hwan Yook, Young Kyu Park, Sung Hoon Roh, Wan Sik Yu, Jae Moon Bae
Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial
Jochen Gensichen, Thomas S Hiller, Jörg Breitbart, Tobias Teismann, Christian Brettschneider, Ulrike Schumacher, Alexander Piwtorak, Hans-Helmut König, Heike Hoyer, Nico Schneider, Mercedes Schelle, Wolfgang Blank, Paul Thiel, Michel Wensing, Jürgen Margraf
The chronic autoimmune thyroiditis quality of life selenium trial (CATALYST): study protocol for a randomized controlled trial
Kristian Hillert Winther, Torquil Watt, Jakob Bue Bjørner, Per Cramon, Ulla Feldt-Rasmussen, Christian Gluud, Jeppe Gram, Mogens Groenvold, Laszlo Hegedüs, Nils Knudsen, Åse Krogh Rasmussen, Steen Joop Bonnema
Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial
Stella Cecchetti, Bruno Pereira, Antoine Roche, Christophe Deschaumes, Dihya Abdi, Emmanuel Coudeyre, Jean-Jacques Dubost, Sylvain Mathieu, Sandrine Malochet-Guinamand, Anne Tournadre, Marion Couderc, Marielle Vayssade, Coline Daron, Martin Soubrier
Remote ischemic preconditioning to reduce contrast-induced nephropathy: study protocol for a randomized controlled trial
Thomas B Sterenborg, Theo P Menting, Yvonne de Waal, Rogier Donders, Kimberley E Wever, M Susan Lemson, Daan JA van der Vliet, Jack F Wetzels, Leo J SchultzeKool, Michiel C Warlé
A pilot study of respiratory muscle training to improve cough effectiveness and reduce the incidence of pneumonia in acute stroke: study protocol for a randomized controlled trial
Stefan Tino Kulnik, Gerrard Francis Rafferty, Surinder S Birring, John Moxham, Lalit Kalra
A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial
Jeanne T Black, Patrick S Romano, Banafsheh Sadeghi, Andrew D Auerbach, Theodore G Ganiats, Sheldon Greenfield, Sherrie H Kaplan, Michael K Ong
Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial
Sandra Meinich Petersen, Vibeke Zoffmann, Jesper Kjærgaard, Lone Graff Steensballe, Gorm Greisen
Tailored Implementation for Chronic Diseases (TICD): a protocol for process evaluation in cluster randomized controlled trials in five European countries
Cornelia Jäger, Tobias Freund, Jost Steinhäuser, Eivind Aakhus, Signe Flottorp, Maciek Godycki-Cwirko, Jan van Lieshout, Jane Krause, Joachim Szecsenyi, Michel Wensing
Smoking Cessation and Reduction in Schizophrenia (SCARIS) with e-cigarette: study protocol for a randomized control trial
Pasquale Caponnetto, Riccardo Polosa, Roberta Auditore, Giuseppe Minutolo, Maria Signorelli, Marilena Maglia, Angela Alamo, Filippo Palermo, Eugenio Aguglia
Acupuncture for functional dyspepsia: study protocol for a two-center, randomized controlled trial
Gajin Han, Seok-Jae Ko, Jae-Woo Park, Jinsung Kim, Inkwon Yeo, Hyejung Lee, Song-Yi Kim, Hyangsook Lee
Exploring mechanisms of fatigue during repeated exercise and the dose dependent effects of carbohydrate and protein ingestion: study protocol for a randomised controlled trial
Abdullah F Alghannam, Kostas Tsintzas, Dylan Thompson, James Bilzon, James A Betts
The improving care in chronic obstructive lung disease study: CAROL improving processes of care and quality of life of COPD patients in primary care: study protocol for a randomized controlled trial
Claudia Steurer-Stey, Stefan Markun, Kaba Dalla Lana, Anja Frei, Ulrike Held, Michel Wensing, Thomas Rosemann
Primary prevention for risk factors of ischemic stroke with Baduanjin exercise intervention in the community elder population: study protocol for a randomized controlled trial
Guohua Zheng, Bai Chen, Qianying Fang, Hongmei Yi, Qiu Lin, Lidian Chen, Jing Tao, Junzhe Li, Xin Zheng, Moyi Li, Xiulu Lan
A retrospective survey of quality of reporting on randomized controlled trials of metformin for polycystic ovary syndrome
Baoying Chen, Jian Liu, Chun Zhang, Minyan Li
From assessment to improvement of elderly care in general practice using decision support to increase adherence to ACOVE quality indicators: study protocol for randomized control trial
Saeid Eslami, Marjan Askari, Stephanie Medlock, Derk L Arts, Jeremy C Wyatt, Henk CPM van Weert, Sophia E de Rooij, Ameen Abu-Hanna
Evolutionary cognitive therapy versus standard cognitive therapy for depression: a protocol for a blinded, randomized, superiority clinical trial
Cezar Giosan, Oana Cobeanu, Cristina Mogoase, Vlad Muresan, Loretta S Malta, Katarzyna Wyka, Aurora Szentagotai
Use of comparative effectiveness research for similar Chinese patent medicine for angina pectoris of coronary heart disease: a new approach based on patient-important outcomes
Hongbo Cao, Jingbo Zhai, Wei Mu, Xiang Lei, Hongxia Cao, Chunxiang Liu, Hongcai Shang
The MedSeq Project: a randomized trial of integrating whole genome sequencing into clinical medicine
Jason L Vassy, Denise M Lautenbach, Heather M McLaughlin, Sek Won Kong, Kurt D Christensen, Joel Krier, Isaac S Kohane, Lindsay Z Feuerman, Jennifer Blumenthal-Barby, J Scott Roberts, Lisa Soleymani Lehmann, Carolyn Y Ho, Peter A Ubel, Calum A MacRae, Christine E Seidman, Michael F Murray, Amy L McGuire, Heidi L Rehm, Robert C Green
Informing relatives about their hereditary or familial cancer risk: study protocol for a randomized controlled trial
Eveline de Geus, Cora M Aalfs, Mathilde GE Verdam, Hanneke CJM de Haes, Ellen MA Smets
Efficacy of pre-exercise low-level laser therapy on isokinetic muscle performance in individuals with type 2 diabetes mellitus: study protocol for a randomized controlled trial
Cid André Fidelis de Paula Gomes, Ernesto Cesar Pinto Leal-Junior, Daniela Aparecida Biasotto-Gonzalez, Yasmin El-Hage, Fabiano Politti, Tabajara de Oliveira Gonzalez, Almir Vieira Dibai-Filho, Adriano Rodrigues de Oliveira, Marcelo Frigero, Fernanda Colella Antonialli, Adriane Aver Vanin, Paulo de Tarso Camillo de Carvalho
Evaluation of the acceptability, feasibility and effectiveness of two methods of involving patients with disability in developing clinical guidelines: study protocol of a randomized pragmatic pilot trial
Marie-Eve Lamontagne, Kadija Perreault, Marie-Pierre Gagnon
Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial
Ramon RJP van Eekeren, Doeke Boersma, Suzanne Holewijn, Anco Vahl, Jean Paul PM de Vries, Clark J Zeebregts, Michel MPJ Reijnen
Using prophylactic antioxidants to prevent noise-induced hearing damage in young adults: a protocol for a double-blind, randomized controlled trial
Annick Gilles, Berina Ihtijarevic, Kristien Wouters, Paul Van de Heyning
Evaluation of computer-assisted mandibular reconstruction with vascularized iliac crest bone graft compared to conventional surgery: a randomized prospective clinical trial
Nassim Ayoub, Alireza Ghassemi, Majeed Rana, Marcus Gerressen, Dieter Riediger, Frank Hölzle, Ali Modabber
Bee venom acupuncture, NSAIDs or combined treatment for chronic neck pain: study protocol for a randomized, assessor-blind trial
Byung-Kwan Seo, Jun-Hwan Lee, Pil-Kun Kim, Yong-Hyeon Baek, Dae-Jean Jo, Sanghun Lee
Update on the Preventive Antibiotics in Stroke Study (PASS): a randomised controlled phase 3 clinical trial
Willeke F Westendorp, Jan-Dirk Vermeij, Nan van Geloven, Diederik WJ Dippel, Marcel GW Dijkgraaf, Tom van der Poll, Jan M Prins, Lodewijk Spanjaard, Frederique H Vermeij, Paul J Nederkoorn, Diederik van de Beek
One or two trainees per workplace in a structured multimodality training curriculum for laparoscopic surgery? Study protocol for a randomized controlled trial – DRKS00004675
Felix Nickel, Felix Jede, Andreas Minassian, Matthias Gondan, Jonathan D Hendrie, Tobias Gehrig, Georg R Linke, Martina Kadmon, Lars Fischer, Beat P Müller-Stich
The risks and rewards of covariate adjustment in randomized trials: an assessment of 12 outcomes from 8 studies
Brennan C Kahan, Vipul Jairath, Caroline J Doré, Tim P Morris
Fractional flow reserve or optical coherence tomography guidance to revascularize intermediate coronary stenosis using angioplasty (FORZA) trial: study protocol for a randomized controlled trial
Francesco Burzotta, Antonio Maria Leone, Giovanni Luigi De Maria, Giampaolo Niccoli, Valentina Coluccia, Giancarlo Pirozzolo, Silvia Saffioti, Cristina Aurigemma, Carlo Trani, Filippo Crea
A feasibility study to inform the design of a randomized controlled trial to identify the most clinically and cost effective Anticoagulation Length with low molecular weight heparin In the treatment of Cancer Associated Thrombosis (ALICAT): study protocol for a mixed-methods study
Joanna D Smith, Jessica Baillie, Trevor Baglin, Gareth O Griffiths, Angela Casbard, David Cohen, David A Fitzmaurice, Kerenza Hood, Peter Rose, Alexander T Cohen, Miriam Johnson, Anthony Maraveyas, John Bell, Harold Toone, Annmarie Nelson, Simon I Noble
Acupuncture for low back pain due to spondylolisthesis: study protocol for a randomized controlled pilot trial
Hyun-jong Lee, Jung-Chul Seo, Min-Ah Kwak, Sung-Hoon Park, Bo-Mi Min, Min-su Cho, ImHee Shin, Jin-yong Jung, Woon-seok Roh
Feedback versus no feedback in improving patient outcome in group psychotherapy for eating disorders (F-EAT): protocol for a randomized clinical trial
Annika Helgadóttir Davidsen, Stig Poulsen, Mette Waaddegaard, Jane Lindschou, Marianne Lau
Effectiveness of a programme of exercise on physical function in survivors of critical illness following discharge from the ICU: study protocol for a randomised controlled trial (REVIVE)
Brenda O'Neill, Kathryn McDowell, Judy Bradley, Bronagh Blackwood, Brian Mullan, Gavin Lavery, Ashley Agus, Sally Murphy, Evie Gardner, Daniel F McAuley
To investigate the prevention of OM-85 on bronchiectasis exacerbations (iPROBE) in Chinese patients: study protocol for a randomized controlled trial
Jinming Gao, Xiang Gao, Lingfei Kong
Adapted motivational interviewing to improve the uptake of treatment for glaucoma in Nigeria: study protocol for a randomized controlled trial
Mohammed M Abdull, Clare Gilbert, Jim McCambridge, Jennifer Evans
Live birth after fresh embryo transfer vs elective embryo cryopreservation/frozen embryo transfer in women with polycystic ovary syndrome undergoing IVF (FreFro-PCOS): study protocol for a multicenter, prospective, randomized controlled clinical trial
Yuhua Shi, Daimin Wei, Xiaoyan Liang, Yun Sun, Jiayin Liu, Yunxia Cao, Bo Zhang, Richard S Legro, Heping Zhang, Zi-Jiang Chen
Bortezomib in late antibody-mediated kidney transplant rejection (BORTEJECT Study): study protocol for a randomized controlled trial
Farsad Eskandary, Gregor Bond, Elisabeth Schwaiger, Zeljko Kikic, Christine Winzer, Markus Wahrmann, Lena Marinova, Helmuth Haslacher, Heinz Regele, Rainer Oberbauer, Georg A Böhmig
Motivational interviewing with American Indian mothers to prevent early childhood caries: study design and methodology of a randomized control trial
Terrence Batliner, Karen A Fehringer, Tamanna Tiwari, William G Henderson, Anne Wilson, Angela G Brega, Judith Albino
Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit
Catrin Tudur Smith, Paula Williamson, Ashley Jones, Alan Smyth, Simon Langton Hewer, Carrol Gamble
Acupuncture at local and distal points for chronic shoulder pain: study protocol for a randomized controlled trial
Qing-Nan Fu, Guang-Xia Shi, Qian-Qian Li, Tian He, Bao-Zhen Liu, San-Feng Sun, Jun Wang, Cheng Tan, Bo-Feng Yang, Cun-Zhi Liu
Evaluation of different recruitment and randomisation methods in a trial of general practitioner-led interventions to increase physical activity: a randomised controlled feasibility study with factorial design
Fiona C Warren, Kate Stych, Margaret Thorogood, Deborah J Sharp, Marie Murphy, Katrina M Turner, Tim A Holt, Aidan Searle, Susan Bryant, Caroline Huxley, Rod S Taylor, John L Campbell, Melvyn Hillsdon
Plasma fatty acid changes following consumption of dietary oils containing n-3, n-6, and n-9 fatty acids at different proportions: preliminary findings of the Canola Oil Multicenter Intervention Trial (COMIT)
Vijitha K Senanayake, Shuaihua Pu, David A Jenkins, Benoît Lamarche, Penny M Kris-Etherton, Sheila G West, Jennifer A Fleming, Xiaoran Liu, Cindy E McCrea, Peter J Jones
‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial
Gail A Mountain, Daniel Hind, Rebecca Gossage-Worrall, Stephen J Walters, Rosie Duncan, Louise Newbould, Saleema Rex, Carys Jones, Ann Bowling, Mima Cattan, Angela Cairns, Cindy Cooper, Rhiannon Tudor Edwards, Elizabeth C Goyder
Optimizing linkage and retention to hypertension care in rural Kenya (LARK hypertension study): study protocol for a randomized controlled trial
Rajesh Vedanthan, Jemima H Kamano, Violet Naanyu, Allison K Delong, Martin C Were, Eric A Finkelstein, Diana Menya, Constantine O Akwanalo, Gerald S Bloomfield, Cynthia A Binanay, Eric J Velazquez, Joseph W Hogan, Carol R Horowitz, Thomas S Inui, Sylvester Kimaiyo, Valentin Fuster
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, Jon Skranes, Gro CC Løhaugen
Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial
Maciek Godycki-Cwirko, Izabela Zakowska, Katarzyna Kosiek, Michel Wensing, Jaroslaw Krawczyk, Anna Kowalczyk
Low-intensity internet-delivered treatment for generalized anxiety symptoms in routine care: protocol for a randomized controlled trial
Derek Richards, Ladislav Timulak, Gavin Doherty, John Sharry, Orla McLoughlin, Chuck Rashleigh, Amy Colla, Ciara Joyce
Efficacy and cost-effectiveness of an experimental short-term inpatient Dialectical Behavior Therapy (DBT) program: study protocol for a randomized controlled trial
Louisa M C van den Bosch, Roland Sinnaeve, Leona Hakkaart-van Roijen, Eric F van Furth
Comparison of conventional medicine, TCM treatment, and combination of both conventional medicine and TCM treatment for patients with chronic obstructive pulmonary disease: study protocol of a randomized comparative effectiveness research trial
Jian-sheng Li, Yang Xie, Su-yun Li, Xue-qing Yu
Supported cognitive-behavioural self-help versus treatment-as-usual for depressed informal carers of stroke survivors (CEDArS): study protocol for a feasibility randomized controlled trial
Joanne Woodford, Paul Farrand, Edward R Watkins, David A Richards, David J Llewellyn
Preoperative inspiratory muscle training to prevent postoperative pulmonary complications in patients undergoing esophageal resection (PREPARE study): study protocol for a randomized controlled trial
Karin Valkenet, Jaap CA Trappenburg, Rik Gosselink, Meindert N Sosef, Jerome Willms, Camiel Rosman, Heleen Pieters, Joris JG Scheepers, Saskia C de Heus, John V Reynolds, Emer Guinan, Jelle P Ruurda, Els HE Rodrigo, Philippe Nafteux, Marianne Fontaine, Ewout A Kouwenhoven, Margot Kerkemeyer, Donald L van der Peet, Sylvia W Hania, Richard van Hillegersberg, Frank JG Backx
Spironolactone to prevent cardiovascular events in early-stage chronic kidney disease (STOP-CKD): study protocol for a randomized controlled pilot trial
Khai P Ng, Poorva Jain, Gurdip Heer, Val Redman, Odette L Chagoury, George Dowswell, Sheila Greenfield, Nick Freemantle, Jonathan N Townend, Paramjit S Gill, Richard J McManus, Charles J Ferro
The effect of mannitol on intraoperative brain relaxation in patients undergoing supratentorial tumor surgery: study protocol for a randomized controlled trial
Yuming Peng, Xiaoyuan Liu, Aidong Wang, Ruquan Han
Study protocol for a randomized controlled trial comparing the efficacy of a specialist and a generic parenting programme for the treatment of preschool ADHD
Donna C McCann, Margaret Thompson, David Daley, Joanne Barton, Cathy Laver-Bradbury, Judy Hutchings, David Coghill, Louise Stanton, Tom Maishman, Liz Dixon, Josh Caddy, Maria Chorozoglou, James Raftery, Edmund Sonuga-Barke
Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial–a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial
Nathan R Hill, Daniel Lasserson, Ben Thompson, Rafael Perera-Salazar, Jane Wolstenholme, Peter Bower, Thomas Blakeman, David Fitzmaurice, Paul Little, Gene Feder, Nadeem Qureshi, Maarten Taal, Jonathan Townend, Charles Ferro, Richard McManus, FD Richard Hobbs
Early specific cognitive-behavioural psychotherapy in subjects at high risk for bipolar disorders: study protocol for a randomised controlled trial
Andrea Pfennig, Karolina Leopold, Andreas Bechdolf, Christoph U Correll, Martin Holtmann, Martin Lambert, Carolin Marx, Thomas D Meyer, Steffi Pfeiffer, Andreas Reif, Maren Rottmann-Wolf, Natalie M Schmitt, Thomas Stamm, Georg Juckel, Michael Bauer
The effect of transcutaneous electrical acupoint stimulation on pregnancy rates in women undergoing in vitro fertilization: a study protocol for a randomized controlled trial
Cui Hong Zheng, Juan Zhang, Jing Wu, Ming Min Zhang
MIDSHIPS: Multicentre Intervention Designed for Self-Harm using Interpersonal Problem-Solving: protocol for a randomised controlled feasibility study
Michelle Collinson, David Owens, Paul Blenkiron, Kayleigh Burton, Liz Graham, Simon Hatcher, Allan House, Katie Martin, Louise Pembroke, David Protheroe, Sandy Tubeuf, Amanda Farrin
The CONSENSUS study: protocol for a mixed methods study to establish which outcomes should be included in a core outcome set for oropharyngeal cancer
Aoife MI Waters, Catrin Tudur Smith, Bridget Young, Terry M Jones
Combining motivational and volitional strategies to promote unsupervised walking in patients with fibromyalgia: study protocol for a randomized controlled trial
María-Ángeles Pastor, Sofía López-Roig, Ana Lledó, Cecilia Peñacoba, Lilian Velasco, Inge Schweiger-Gallo, Margarita Cigarán, Carmen Écija, Ramón Limón, Yolanda Sanz
Variable versus conventional lung protective mechanical ventilation during open abdominal surgery: study protocol for a randomized controlled trial
Peter M Spieth, Andreas Güldner, Christopher Uhlig, Thomas Bluth, Thomas Kiss, Marcus J Schultz, Paolo Pelosi, Thea Koch, Marcelo Gama de Abreu
Optimization of the viability of stem cells derived from umbilical cord blood after maternal supplementation with DHA during the second or third trimester of pregnancy: study protocol for a randomized controlled trial
Irene Martini, Enea Gino Di Domenico, Roberta Scala, Francesca Caruso, Carla Ferreri, Filippo M Ubaldi, Andrea Lenzi, Herbert Valensise
The challenge of recruiting patients into a placebo-controlled surgical trial
Kristoffer B Hare, L Stefan Lohmander, Ewa M Roos
Short course daily prednisolone therapy during an upper respiratory tract infection in children with relapsing steroid-sensitive nephrotic syndrome (PREDNOS 2): protocol for a randomised controlled trial
Nicholas J A Webb, Emma Frew, Elizabeth A Brettell, David V Milford, Detlef Bockenhauer, Moin A Saleem, Martin Christian, Angela S Hall, Ania Koziell, Heather Maxwell, Shivram Hegde, Eric R Finlay, Rodney D Gilbert, Jenny Booth, Caroline Jones, Karl McKeever, Wendy Cook, Natalie J Ives
Effects of the traditional Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: a study protocol for a multicenter, randomized, controlled clinical trial
Nan Peng, Yi Zhang, Cong Ma, Ming-Wei Yu, Guo-Wang Yang, Qi Fu, Wei-Ru Xu, Xiao-Min Wang
Detailed statistical analysis plan for the difficult airway management (DIFFICAIR) trial
Anders Kehlet Nørskov, Lars Hyldborg Lundstrøm, Charlotte Vallentin Rosenstock, Jørn Wetterslev
Comparing the effect of clopidogrel versus ticagrelor on coronary microvascular dysfunction in acute coronary syndrome patients (TIME trial): study protocol for a randomized controlled trial
Sang-Don Park, Yong-Soo Baek, Seong-Ill Woo, Soo-Han Kim, Sung-Hee Shin, Dae-Hyeok Kim, Jun Kwan, Keum-Soo Park
Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial
Ryan T Anderson, Victor M Montori, Nilay D Shah, Henry H Ting, Laurie J Pencille, Michel Demers, Jeffrey A Kline, Deborah B Diercks, Judd E Hollander, Carlos A Torres, Jason T Schaffer, Jeph Herrin, Megan Branda, Annie Leblanc, Erik P Hess
Guidance and examination by ultrasound versus landmark and radiographic method for placement of subclavian central venous catheters: study protocol for a randomized controlled trial
Sébastien Perbet, Bruno Pereira, Florian Grimaldi, Christian Dualé, Jean-Etienne Bazin, Jean-Michel Constantin
Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial
Vikki Wylde, Elsa Marques, Neil Artz, Ashley Blom, Rachael Gooberman-Hill
Comparison of face-to-face versus email guided self-help for binge eating: study protocol for a randomised controlled trial
Paul E Jenkins, Amy Luck, Alison Burrows, Nicky Boughton
Impact of emergency department probiotic treatment of pediatric gastroenteritis: study protocol for the PROGUT (Probiotic Regimen for Outpatient Gastroenteritis Utility of Treatment) randomized controlled trial
Stephen B Freedman, Sarah Williamson-Urquhart, Suzanne Schuh, Philip M Sherman, Ken J Farion, Serge Gouin, Andrew R Willan, Ron Goeree, David W Johnson, Karen Black, David Schnadower, Marc H Gorelick
Could digital patient communities be the launch pad for patient-centric trial design?
Paul Wicks
PAHA study: Psychological Active and Healthy Aging: psychological wellbeing, proactive attitude and happiness effects of whole-body vibration versus Multicomponent Training in aged women: study protocol for a randomized controlled trial
Angelo Compare, Cristina Zarbo, Elena Marín, Alessia Meloni, Jacobo A Rubio-Arias, Rosendo Berengüí, Enzo Grossi, Edo Shonin, Gianmaria Martini, Pedro E Alcaraz
Effectiveness and cost-effectiveness of telehealthcare for chronic obstructive pulmonary disease: study protocol for a cluster randomized controlled trial
Flemming Witt Udsen, Pernille Heyckendorff Lilholt, Ole Hejlesen, Lars Holger Ehlers
Effectiveness of mechanical traction as a non-surgical treatment for carpal tunnel syndrome compared to care as usual: study protocol for a randomized controlled trial
Margreet Meems, Brenda Den Oudsten, Berend-Jan Meems, Victor Pop
Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial
Jane M Robertson, Gerard J Molloy, Prasad R Bollina, Daniel M Kelly, S Alan McNeill, Liz Forbat
Changing cluster composition in cluster randomised controlled trials: design and analysis considerations
Neil Corrigan, Michael J G Bankart, Laura J Gray, Karen L Smith
Six weeks of home enteral nutrition versus standard care after esophagectomy or total gastrectomy for cancer: study protocol for a randomized controlled trial
David J Bowrey, Melanie Baker, Vanessa Halliday, Anne L Thomas, Ruth Pulikottil-Jacob, Karen Smith
Processes to manage analyses and publications in a phase III multicenter randomized clinical trial
Kristin K Snow, Margaret C Bell, Anne M Stoddard, Teresa M Curto, Elizabeth C Wright, Jules L Dienstag
Single dental implant retained mandibular complete dentures – influence of the loading protocol: study protocol for a randomized controlled trial
Nicole Passia, Miha Brezavšček, Elfriede Fritzer, Stefanie Kappel, Thomas Kern, Ralph G Luthardt, Nadine Frfr von Maltzahn, Torsten Mundt, Michael Rädel, Axel von Stein-Lausnitz, Matthias Kern
Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial
Edin Mujagic, Tibor Zwimpfer, Walter R Marti, Marcel Zwahlen, Henry Hoffmann, Christoph Kindler, Christoph Fux, Heidi Misteli, Lukas Iselin, Andrea Kopp Lugli, Christian A Nebiker, Urs von Holzen, Fabrizio Vinzens, Marco von Strauss, Stefan Reck, Marko Kraljević, Andreas F Widmer, Daniel Oertli, Rachel Rosenthal, Walter P Weber
Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document
Claudia M Witt, Mikel Aickin, Daniel Cherkin, Chun Tao Che, Charles Elder, Andrew Flower, Richard Hammerschlag, Jian-Ping Liu, Lixing Lao, Steve Phurrough, Cheryl Ritenbaugh, Lee Hullender Rubin, Rosa Schnyer, Peter M Wayne, Shelly Rafferty Withers, Bian Zhao-Xiang, Jeanette Young, Brian M Berman
Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial
Andrea Salazar-Ospina, Pedro Amariles, Dora M Benjumea, Francisco Gutierrez, Maria J Faus, Luis F Rodriguez
Effectiveness of the Epley’s maneuver performed in primary care to treat posterior canal benign paroxysmal positional vertigo: study protocol for a randomized controlled trial
José Luis Ballve Moreno, Ricard Carrillo Muñoz, Iván Villar Balboa, Yolanda Rando Matos, Olga Lucia Arias Agudelo, Asha Vasudeva, Olga Bigas Aguilera, Jesús Almeda Ortega, Alicia Capella Guillén, Clara Johanna Buitrago Olaya, Xavier Monteverde Curto, Estrella Rodero Perez, Carles Rubio Ripollès, Pamela Catalina Sepulveda Palacios, Noemí Moreno Farres, Anabella María Hernández Sánchez, Carlos Martin Cantera, Rafael Azagra Ledesma
The effectiveness of antioxidant vitamins C and E in reducing myocardial infarct size in patients subjected to percutaneous coronary angioplasty (PREVEC Trial): study protocol for a pilot randomized double-blind controlled trial
Ramón Rodrigo, Daniel Hasson, Juan C Prieto, Gastón Dussaillant, Cristóbal Ramos, Lucio León, Javier Gárate, Nicolás Valls, Juan G Gormaz
Femoral nerve block Intervention in Neck of Femur fracture (FINOF): study protocol for a randomized controlled trial
Opinder Sahota, Martin Rowlands, Jim Bradley, Gerrie Van de Walt, Nigel Bedforth, Sarah Armstrong, Iain Moppett
Internet-based cognitive bias modification for obsessive compulsive disorder: study protocol for a randomized controlled trial
Alishia D Williams, Rosanna Pajak, Kathleen O’Moore, Gavin Andrews, Jessica R Grisham
The ENHANCES study—Enhancing Head and Neck Cancer patients’ Experiences of Survivorship: study protocol for a randomized controlled trial
Jane Turner, Patsy Yates, Lizbeth Kenny, Louisa G Gordon, Bryan Burmeister, Damien Thomson, Brett Hughes, Alexandra L McCarthy, Chris Perry, Raymond J Chan, Alana Fraser, Helen Skerman, Martin Batstone, Kathryn Carswell
METFORMIN: an efficacy, safety and pharmacokinetic study on the short-term and long-term use in obese children and adolescents – study protocol of a randomized controlled study
Marloes P van der Aa, Marieke AJ Elst, Edgar GAH van Mil, Catherijne AJ Knibbe, Marja MJ van der Vorst
Comparison of complementary and alternative medicine with conventional mind–body therapies for chronic back pain: protocol for the Mind–body Approaches to Pain (MAP) randomized controlled trial
Daniel C Cherkin, Karen J Sherman, Benjamin H Balderson, Judith A Turner, Andrea J Cook, Brenda Stoelb, Patricia M Herman, Richard A Deyo, Rene J Hawkes
A Randomized trial of an Asthma Internet Self-management Intervention (RAISIN): study protocol for a randomized controlled trial
Deborah Morrison, Sally Wyke, Neil C Thomson, Alex McConnachie, Karolina Agur, Kathryn Saunderson, Rekha Chaudhuri, Frances S Mair
Developmentally adapted cognitive processing therapy for adolescents and young adults with PTSD symptoms after physical and sexual abuse: study protocol for a randomized controlled trial
Rita Rosner, Hans-Helmut König, Frank Neuner, Ulrike Schmidt, Regina Steil
Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial
Ying Li, Hui Zheng, Qianhua Zheng, Ling Zhao, Erqi Qin, Yu Wang, Qian Zeng, Huabin Zheng, Yu Zhao, Wei Sun, Xiaoxia Zhang, Zhishun Liu, Baoyan Liu
Using marketing theory to inform strategies for recruitment: a recruitment optimisation model and the txt2stop experience
Leandro Galli, Rosemary Knight, Steven Robertson, Elizabeth Hoile, Olubukola Oladapo, David Francis, Caroline Free
The DiaS trial: dialectical behavior therapy versus collaborative assessment and management of suicidality on self-harm in patients with a recent suicide attempt and borderline personality disorder traits - study protocol for a randomized controlled trial
Kate Andreasson, Jesper Krogh, Bent Rosenbaum, Christian Gluud, David A Jobes, Merete Nordentoft
Incorporating external evidence in trial-based cost-effectiveness analyses: the use of resampling methods
Mohsen Sadatsafavi, Carlo Marra, Shawn Aaron, Stirling Bryan
WELLFOCUS PPT – modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial
Beate Schrank, Simon Riches, Tony Coggins, Tayyab Rashid, Andre Tylee, Mike Slade
Peer volunteers in an integrative pain management program for frail older adults with chronic pain: study protocol for a randomized controlled trial
Mimi Mun Yee Tse, Paul Hong Lee, Sheung Mei Ng, Bik Kwan Tsien-Wong, Suey Shuk Yu Yeung
Examination of mechanisms (E-MECHANIC) of exercise-induced weight compensation: study protocol for a randomized controlled trial
Candice A Myers, William D Johnson, Conrad P Earnest, Jennifer C Rood, Catrine Tudor-Locke, Neil M Johannsen, Shannon Cocreham, Melissa Harris, Timothy S Church, Corby K Martin
Acupuncture for acute stroke: study protocol for a multicenter, randomized, controlled trial
Lifang Chen, Jianqiao Fang, Ruijie Ma, Ronen Froym, Xudong Gu, Jianhua Li, Lina Chen, Shouyu Xu, Conghua Ji
Pilot study evaluating broccoli sprouts in advanced pancreatic cancer (POUDER trial) - study protocol for a randomized controlled trial
Vladimir J Lozanovski, Philipp Houben, Ulf Hinz, Thilo Hackert, Ingrid Herr, Peter Schemmer
The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: study protocol for a randomised controlled trial
Michelle M Dowsey, David J Castle, Simon R Knowles, Kaveh Monshat, Michael R Salzberg, Peter F M Choong
The STRIDE (Strategies to Increase confidence, InDependence and Energy) study: cognitive behavioural therapy-based intervention to reduce fear of falling in older fallers living in the community - study protocol for a randomised controlled trial
Steve W Parry, Vincent Deary, Tracy Finch, Claire Bamford, Neil Sabin, Peter McMeekin, John O’Brien, Alma Caldwell, Nick Steen, Susan L Whitney, Claire Macdonald, Elaine McColl
Lee Silverman voice treatment versus standard NHS speech and language therapy versus control in Parkinson’s disease (PD COMM pilot): study protocol for a randomized controlled trial
Catherine M Sackley, Christina H Smith, Caroline Rick, Marian C Brady, Natalie Ives, Ramilla Patel, Helen Roberts, Francis Dowling, Sue Jowett, Keith Wheatley, Smitaa Patel, Debbie Kelly, Gina Sands, Carl Clarke
Getting added value from using qualitative research with randomized controlled trials: a qualitative interview study
Alicia O’Cathain, Jackie Goode, Sarah J Drabble, Kate J Thomas, Anne Rudolph, Jenny Hewison
Furosemide and albumin for diuresis of edema (FADE): a study protocol for a randomized controlled trial
Simon JW Oczkowski, Ian Mazzetti, Maureen O Meade, Cindy Hamielec
Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study
Jason W Busse, Mohit Bhandari, Thomas A Einhorn, James D Heckman, Kwok-Sui Leung, Emil Schemitsch, Paul Tornetta III, Stephen D Walter, Gordon H Guyatt
Comparison of an interactive with a didactic educational intervention for improving the evidence-based practice knowledge of occupational therapists in the public health sector in South Africa: a randomised controlled trial
Helen Buchanan, Nandi Siegfried, Jennifer Jelsma, Carl Lombard
A written self-help intervention for depressed adults comparing behavioural activation combined with physical activity promotion with a self-help intervention based upon behavioural activation alone: study protocol for a parallel group pilot randomised controlled trial (BAcPAc)
Paul Farrand, Claire Pentecost, Colin Greaves, Rod S Taylor, Fiona Warren, Colin Green, Melvyn Hillsdon, Phil Evans, Jo Welsman, Adrian H Taylor
An efficacy and mechanism evaluation study of Levosimendan for the Prevention of Acute oRgan Dysfunction in Sepsis (LeoPARDS): protocol for a randomized controlled trial
Robert M L’E Orme, Gavin D Perkins, Daniel F McAuley, Kathleen D Liu, Alexina J Mason, Andrea Morelli, Mervyn Singer, Deborah Ashby, Anthony C Gordon
Toward onset prevention of cognitive decline in adults with Down syndrome (the TOP-COG study): study protocol for a randomized controlled trial
Sally-Ann Cooper, Muriel Caslake, Jonathan Evans, Angela Hassiotis, Andrew Jahoda, Alex McConnachie, Jill Morrison, Howard Ring, John Starr, Ciara Stiles, Frank Sullivan
Cluster randomized trials utilizing primary care electronic health records: methodological issues in design, conduct, and analysis (eCRT Study)
Martin C Gulliford, Tjeerd P van Staa, Lisa McDermott, Gerard McCann, Judith Charlton, Alex Dregan
A feasible strategy for preventing blood clots in critically ill patients with acute kidney injury (FBI): study protocol for a randomized controlled trial
Sian Robinson, Aleksander Zincuk, Ulla Lei Larsen, Claus Ekstrøm, Palle Toft
Staged transthoracic approach to persistent atrial fibrillation (TOP-AF): study protocol for a randomized trial
Claudio Pragliola, Pasquale Mastroroberto, Mario Gaudino, Massimo Chello, Elvio Covino
The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of dementia screening (CHOICE) study: study protocol for a randomized controlled trial
Nicole R Fowler, Amanda Harrawood, Amie Frame, Anthony J Perkins, Sujuan Gao, Christopher M Callahan, Greg A Sachs, Dustin D French, Malaz A Boustani
Update to the study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment depressive relapse/recurrence: the PREVENT trial
Willem Kuyken, Sarah Byford, Richard Byng, Tim Dalgleish, Glyn Lewis, Rod Taylor, Edward R Watkins, Rachel Hayes, Paul Lanham, David Kessler, Nicola Morant, Alison Evans
The EUPHRATES trial (Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic shock): study protocol for a randomized controlled trial
David J Klein, Debra Foster, Christa A Schorr, Kazem Kazempour, Paul M Walker, R Phillip Dellinger
Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial
Marie Pirotta, Carolyn Ee, Helena Teede, Patty Chondros, Simon French, Stephen Myers, Charlie Xue
Telephone-delivered behavioral intervention among blacks with sleep apnea and metabolic syndrome: study protocol for a randomized controlled trial
Natasha J Williams, Girardin Jean-Louis, Clinton D Brown, Samy I McFarlane, Carla Boutin-Foster, Gbenga Ogedegbe
Effects of continuous prostacyclin infusion on regional blood flow and cerebral vasospasm following subarachnoid haemorrhage: statistical analysis plan for a randomized controlled trial
Rune Rasmussen, Marianne Juhler, Jørn Wetterslev
Statistical analysis plan for the Stroke Oxygen Study (SO2S): a multi-center randomized controlled trial to assess whether routine oxygen supplementation in the first 72 hours after a stroke improves long-term outcome
Julius Sim, Richard Gray, Tracy Nevatte, Andrew Howman, Natalie Ives, Christine Roffe
Fluoxetine for Autistic Behaviors (FAB trial): study protocol for a randomized controlled trial in children and adolescents with autism
Anissa Mouti, Dinah Reddihough, Catherine Marraffa, Philip Hazell, John Wray, Katherine Lee, Michael Kohn
Eradication strategy for persistent methicillin-resistant Staphylococcus aureus infection in individuals with cystic fibrosis—the PMEP trial: study protocol for a randomized controlled trial
Mark T Jennings, Michael P Boyle, David Weaver, Karen A Callahan, Elliott C Dasenbrook
A multi-site single-blind clinical study to compare the effects of STAIR Narrative Therapy to treatment as usual among women with PTSD in public sector mental health settings: study protocol for a randomized controlled trial
Marylene Cloitre, Clare Henn-Haase, Judith L Herman, Christie Jackson, Nadine Kaslow, Constance Klein, Michaela Mendelsohn, Eva Petkova
Cost effectiveness of group follow-up after structured education for type 1 diabetes: a cluster randomised controlled trial
Paddy Gillespie, Eamon O'Shea, Mary Clare O’Hara, Sean F Dinneen
The HYPERFlax trial for determining the anti-HYPERtensive effects of dietary flaxseed in newly diagnosed stage 1 hypertensive patients: study protocol for a randomized, double-blinded, controlled clinical trial
Stephanie PB Caligiuri, Brian Penner, Grant N Pierce
The efficacy of a behavioral activation intervention among depressed US Latinos with limited English language proficiency: study protocol for a randomized controlled trial
Anahi Collado, Katherine E Long, Laura MacPherson, Carl W Lejuez
National Adolescent Treatment Trial for Obesity in Kuwait (NATTO): project design and results of a randomised controlled trial of a good practice approach to treatment of adolescent obesity in Kuwait
Shurooq A Boodai, John H McColl, John J Reilly
Intervention to reduce excessive alcohol consumption and improve comorbidity outcomes in hypertensive or depressed primary care patients: two parallel cluster randomized feasibility trials
Graeme B Wilson, Catherine Wray, Ruth McGovern, Dorothy Newbury-Birch, Elaine McColl, Ann Crosland, Chris Speed, Paul Cassidy, Dave Tomson, Shona Haining, Denise Howel, Eileen FS Kaner
Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial
Zhishun Liu, Yang Wang, Huanfang Xu, Jiani Wu, Liyun He, John Yi Jiang, Shiyan Yan, Ruosang Du, Baoyan Liu
Continuous intra-articular infusion anesthesia for pain control after total knee arthroplasty: study protocol for a randomized controlled trial
Da Guo, Xue-Wei Cao, Jin-Wen Liu, Wen-Wei Ouyang, Jian-Ke Pan, Jun Liu
Comparison of a standard CO2 pressure pneumoperitoneum insufflator versus AirSeal™: study protocol of a randomized controlled trial
Ruzica Rosalia Luketina, Michael Knauer, Gernot Köhler, Oliver Owen Koch, Klaus Strasser, Margot Egger, Klaus Emmanuel
Medial open transversus abdominis plane (MOTAP) catheters for analgesia following open liver resection: study protocol for a randomized controlled trial
Paul Karanicolas, Sean Cleary, Paul McHardy, Stuart McCluskey, Jason Sawyer, Salima Ladak, Calvin Law, Alice Wei, Natalie Coburn, Raynauld Ko, Joel Katz, Alex Kiss, James Khan, Srinivas Coimbatore, Jenny Lam-McCulloch, Hance Clarke
Vancomycin versus daptomycin for the treatment of methicillin-resistant Staphylococcus aureus bacteremia due to isolates with high vancomycin minimum inhibitory concentrations: study protocol for a phase IIB randomized controlled trial
Shirin Kalimuddin, Rachel Phillips, Mihir Gandhi, Nurun Nisa de Souza, Jenny GH Low, Sophia Archuleta, David Lye, Thuan Tong Tan
Mobile phone text messaging intervention to improve alertness and reduce sleepiness and fatigue during shiftwork among emergency medicine clinicians: study protocol for the SleepTrackTXT pilot randomized controlled trial
Paul Daniel Patterson, Charity G Moore, Matthew D Weaver, Daniel J Buysse, Brian P Suffoletto, Clifton W Callaway, Donald M Yealy
Effectiveness of the head CT choice decision aid in parents of children with minor head trauma: study protocol for a multicenter randomized trial
Erik P Hess, Kirk D Wyatt, Anupam B Kharbanda, Jeffrey P Louie, Peter S Dayan, Leah Tzimenatos, Sandra L Wootton-Gorges, James L Homme, Laurie Pencille RN, Annie LeBlanc, Jessica J Westphal, Kathy Shepel, Nilay D Shah, Megan Branda, Jeph Herrin, Victor M Montori, Nathan Kuppermann
Evaluation of a corticotropin releasing hormone type 1 receptor antagonist in women with posttraumatic stress disorder: study protocol for a randomized controlled trial
Boadie W Dunlop, Barbara O Rothbaum, Elisabeth B Binder, Erica Duncan, Philip D Harvey, Tanja Jovanovic, Mary E Kelley, Becky Kinkead, Michael Kutner, Dan V Iosifescu, Sanjay J Mathew, Thomas C Neylan, Clinton D Kilts, Charles B Nemeroff, Helen S Mayberg
Practice network-based care management for patients with type 2 diabetes and multiple comorbidities (GEDIMAplus): study protocol for a randomized controlled trial
Kayvan Bozorgmehr, Joachim Szecsenyi, Dominik Ose, Werner Besier, Manfred Mayer, Johannes Krisam, Christian O Jacke, Hans-Joachim Salize, Ralf Brandner, Sandra Schmitt, Marion Kiel, Martina Kamradt, Tobias Freund
Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’
Cecilia A C Prinsen, Sunita Vohra, Michael R Rose, Susanne King-Jones, Sana Ishaque, Zafira Bhaloo, Denise Adams, Caroline B Terwee
The effect of ‘sleep high and train low’ on weight loss in overweight Chinese adolescents: study protocol for a randomized controlled trial
Ru Wang, Dongmei Liu, Xueqiang Wang, Weihua Xiao, Nana Wu, Binghong Gao, Peijie Chen
Compliance of mothers following recommendations to breastfeed or withhold breast milk during rotavirus vaccination in North India: a randomized clinical trial
Temsunaro Rongsen-Chandola, Brita Askeland Winje, Nidhi Goyal, Sudeep Singh Rathore, Madhu Mahesh, Rajat Ranjan, Alok Arya, Farhana Afzal Rafiqi, Nita Bhandari, Tor A Strand
The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial
Kerry NL Avery, Chris Metcalfe, Richard Berrisford, C Paul Barham, Jenny L Donovan, Jackie Elliott, Stephen J Falk, Rob Goldin, George Hanna, Andrew A Hollowood, Richard Krysztopik, Sian Noble, Grant Sanders, Christopher G Streets, Dan R Titcomb, Tim Wheatley, Jane M Blazeby
INtegration of DEPression Treatment into HIV Care in Uganda (INDEPTH-Uganda): study protocol for a randomized controlled trial
Glenn J Wagner, Victoria Ngo, Peter Glick, Ekwaro A Obuku, Seggane Musisi, Dickens Akena
Prognosis after ST-elevation myocardial infarction: a study on cardiac magnetic resonance imaging versus clinical routine
Suzanne de Waha, Ingo Eitel, Steffen Desch, Georg Fuernau, Philipp Lurz, Thomas Stiermaier, Stephan Blazek, Gerhard Schuler, Holger Thiele
Corticosteroid treatment for community-acquired pneumonia - the STEP trial: study protocol for a randomized controlled trial
Claudine A Blum, Nicole Nigro, Bettina Winzeler, Isabelle Suter-Widmer, Philipp Schuetz, Matthias Briel, Roland Bingisser, Werner Zimmerli, Elke Ullmer, Hanno Elsaesser, Philip Tarr, Sebastian Wirz, Robert Thomann, Eveline Hofmann, Nicolas Rodondi, Hervé Duplain, Dieter Burki, Beat Mueller, Mirjam Christ-Crain
Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial
Sophy TF Shih, Nathalie Davis-Lameloise, Edward D Janus, Carol Wildey, Vincent L Versace, Virginia Hagger, Dino Asproloupos, Sharleen L O’Reilly, Paddy A Phillips, Michael Ackland, Timothy Skinner, Jeremy Oats, Rob Carter, James D Best, James A Dunbar
Economic support to improve tuberculosis treatment outcomes in South Africa: a qualitative process evaluation of a cluster randomized controlled trial
Elizabeth Lutge, Simon Lewin, Jimmy Volmink
Forced diuresis with matched hydration in reducing acute kidney injury during transcatheter aortic valve implantation (Reduce-AKI): study protocol for a randomized sham-controlled trial
Yaron Arbel, Eyal Ben-Assa, Amir Halkin, Gad Keren, Arie Lorin Schwartz, Ofer Havakuk, Eran Leshem-Rubinow, Maayan Konigstein, Arie Steinvil, Yigal Abramowitz, Ariel Finkelstein, Shmuel Banai
A review of the handling of missing longitudinal outcome data in clinical trials
Matthew Powney, Paula Williamson, Jamie Kirkham, Ruwanthi Kolamunnage-Dona
Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial
Sam McClinton, Kathryn Starr, Ruth Thomas, Graeme McLennan, Gladys McPherson, Alison McDonald, Thomas Lam, James N’Dow, Mary Kilonzo, Robert Pickard, Ken Anson, Jennifer Burr
Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial
Brandon Kandarian, R Sean Morrison, Lynne D Richardson, Joanna Ortiz, Corita R Grudzen
Evaluating the efficacy of an integrated smoking cessation intervention for mental health patients: study protocol for a randomised controlled trial
Alexandra P Metse, Jenny A Bowman, Paula Wye, Emily Stockings, Maree Adams, Richard Clancy, Margarett Terry, Luke Wolfenden, Megan Freund, John Allan, Judith J Prochaska, John Wiggers
The effects of two Chinese herbal medicinal formulae vs. placebo controls for treatment of allergic rhinitis: a randomised controlled trial
Rose YP Chan, Wai Tong Chien
Stoma-Const - the technical aspects of stoma construction: study protocol for a randomised controlled trial
Adiela Correa Marinez, Sofia Erestam, Eva Haglind, Jan Ekelund, Ulf Angerås, Jacob Rosenberg, Frederik Helgstrand, Eva Angenete
Cognitive bias modification to prevent depression (COPE): study protocol for a randomised controlled trial
Osvaldo P Almeida, Colin MacLeod, Andrew Ford, Ben Grafton, Varsha Hirani, David Glance, Emily Holmes
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
The effects of a brief CBT intervention, delivered by frontline mental health staff, to promote recovery in people with psychosis and comorbid anxiety or depression (the GOALS study): study protocol for a randomized controlled trial
Helen Waller, Tom Craig, Sabine Landau, Miriam Fornells-Ambrojo, Nedah Hassanali, Catherine Iredale, Suzanne Jolley, Paul McCrone, Philippa Garety
Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial
Alison T Brenner, Christina M Getrich, Michael Pignone, Robert L Rhyne, Richard M Hoffman, Andrew McWilliams, Brisa Urquieta de Hernandez, Mark A Weaver, Hazel Tapp, Khalil Harbi, Daniel Reuland
Traditional Chinese medicine (Shun-Qi-Tong-Xie Granule) for irritable bowel syndrome: study protocol for a randomised controlled trial
Xiao-xiang Wang, Rui-jie Luo, Bin She, Yan Chen, Jia Guo
Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial
Marije Bosch, Joanne E McKenzie, Duncan Mortimer, Emma J Tavender, Jill J Francis, Sue E Brennan, Jonathan C Knott, Jennie L Ponsford, Andrew Pearce, Denise A O’Connor, Jeremy M Grimshaw, Jeffrey V Rosenfeld, Russell L Gruen, Sally E Green
The COMET Initiative database: progress and activities from 2011 to 2013
Elizabeth Gargon, Paula R Williamson, Douglas G Altman, Jane M Blazeby, Mike Clarke
Plain packaging of cigarettes and smoking behavior: study protocol for a randomized controlled study
Olivia M Maynard, Ute Leonards, Angela S Attwood, Linda Bauld, Lee Hogarth, Marcus R Munafò
Do children with cerebral palsy benefit from computerized working memory training? Study protocol for a randomized controlled trial
Gro CC Løhaugen, Harald Beneventi, Guro L Andersen, Cato Sundberg, Heidi Furre Østgård, Ellen Bakkan, Geir Walther, Torstein Vik, Jon Skranes
Sample size calculations in pediatric clinical trials conducted in an ICU: a systematic review
Stavros Nikolakopoulos, Kit C B Roes, Johanna H van der Lee, Ingeborg van der Tweel
Improving Well-being and Health for People with Dementia (WHELD): study protocol for a randomised controlled trial
Rhiannon Whitaker, Jane Fossey, Clive Ballard, Martin Orrell, Esme Moniz-Cook, Robert T Woods, Joanna Murray, Jane Stafford, Martin Knapp, Renee Romeo, Barbara Woodward Carlton, Ingelin Testad, Zunera Khan
Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial
Jorge Vas, José Manuel Aranda-Regules, Manuela Modesto, Inmaculada Aguilar, Mercedes Barón-Crespo, María Ramos-Monserrat, Manuel Quevedo-Carrasco, Francisco Rivas-Ruiz
Impact of drug reconciliation at discharge and communication between hospital and community pharmacists on drug-related problems: study protocol for a randomized controlled trial
Xavier Pourrat, Clarisse Roux, Brigitte Bouzige, Valérie Garnier, Armelle Develay, Benoit Allenet, Martial Fraysse, Jean-Michel Halimi, Jacqueline Grassin, Bruno Giraudeau
Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study
Bernard Schachtel, Sue Aspley, Adrian Shephard, Timothy Shea, Gary Smith, Emily Schachtel
Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study
M Dawn Teare, Munyaradzi Dimairo, Neil Shephard, Alex Hayman, Amy Whitehead, Stephen J Walters
Development and testing of culturally sensitive patient information material for Turkish, Polish, Russian and Italian migrants with depression or chronic low back pain (KULTINFO): study protocol for a double-blind randomized controlled trial
Lars P Hölzel, Zivile Ries, Jördis M Zill, Levente Kriston, Jörg Dirmaier, Martin Härter, Isaac Bermejo
Impact on mortality of the timing of renal replacement therapy in patients with severe acute kidney injury in septic shock: the IDEAL-ICU study (initiation of dialysis early versus delayed in the intensive care unit): study protocol for a randomized controlled trial
Saber Davide Barbar, Christine Binquet, Mehran Monchi, Rémi Bruyère, Jean-Pierre Quenot
The efficacy and safety of Jian-Wei-Qu-Tong Pills for the treatment of chronic non-atrophic gastritis (spleen and stomach qi deficiency with damp-heat stasis syndrome): study protocol for a phase II, randomized controlled trial
Xiao-xin Zhang, Wei-wei Chen, Bin She, Rui-jie Luo, Na Shi, Ping Xue, Xiao-nan Yang, Qing Xia
Antibiotic rotation strategies to reduce antimicrobial resistance in Gram-negative bacteria in European intensive care units: study protocol for a cluster-randomized crossover controlled trial
Pleun J van Duijn, Marc JM Bonten
Five questions that need answering when considering the design of clinical trials
Timothy Clark, Hugh Davies, Ulrich Mansmann
A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial
Ruben Tavares, Karen Anne Beattie, William George Bensen, Raja S Bobba, Alfred A Cividino, Karen Finlay, Ron Goeree, Lawrence Errol Hart, Erik Jurriaans, Maggie J Larche, Naveen Parasu, Jean-Eric Tarride, Colin E Webber, Jonathan D Adachi
Obsessive Compulsive Treatment Efficacy Trial (OCTET) comparing the clinical and cost effectiveness of self-managed therapies: study protocol for a randomised controlled trial
Judith Gellatly, Peter Bower, Dean McMillan, Christopher Roberts, Sarah Byford, Penny Bee, Simon Gilbody, Catherine Arundel, Gillian Hardy, Michael Barkham, Shirley Reynolds, Lina Gega, Patricia Mottram, Nicola Lidbetter, Rebecca Pedley, Emily Peckham, Janice Connell, Jo Molle, Neil O’Leary, Karina Lovell
Using a partially randomized patient preference study design to evaluate the therapeutic effect of acupuncture and cupping therapy for fibromyalgia: study protocol for a partially randomized controlled trial
Hui-Juan Cao, Jian-Ping Liu, Hui Hu, Nissi S Wang
Improving adolescent mental health and resilience through a resilience-based intervention in schools: study protocol for a randomised controlled trial
Julia Dray, Jenny Bowman, Megan Freund, Elizabeth Campbell, Luke Wolfenden, Rebecca K Hodder, John Wiggers
Sepsis survivors monitoring and coordination in outpatient health care (SMOOTH): study protocol for a randomized controlled trial
Konrad Schmidt, Paul Thiel, Friederike Mueller, Katja Schmuecker, Susanne Worrack, Juliane Mehlhorn, Christoph Engel, Katja Brenk-Franz, Stephan Kausche, Ursula Jakobi, Anne Bindara-Klippel, Nico Schneider, Antje Freytag, Dimitry Davydow, Michel Wensing, Frank Martin Brunkhorst, Jochen Gensichen
LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial
Daniele Trevisanuto, Francesco Cavallin, Veronica Mardegan, Nguyen Ngoc Loi, Nguyen Viet Tien, Tran Dieu Linh, Tran Dinh Chien, Nicoletta Doglioni, Lino Chiandetti, Luciano Moccia
A comparison of MEmory Specificity Training (MEST) to education and support (ES) in the treatment of recurrent depression: study protocol for a cluster randomised controlled trial
Tim Dalgleish, Anna Bevan, Anna McKinnon, Lauren Breakwell, Viola Mueller, Isobel Chadwick, Susanne Schweizer, Caitlin Hitchcock, Peter Watson, Filip Raes, Laura Jobson, Aliza Werner-Seidler
Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial
Nicola Lindson-Hawley, Tim Coleman, Graeme Docherty, Peter Hajek, Sarah Lewis, Deborah Lycett, Andy McEwen, Hayden McRobbie, Marcus R Munafò, Steve Parrott, Paul Aveyard
Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial
Johannes Fleckenstein, Petra I Baeumler, Caroline Gurschler, Tobias Weissenbacher, Michael Simang, Thorsten Annecke, Thomas Geisenberger, Dominik Irnich
Physical therapy treatment in patients suffering from cervicogenic somatic tinnitus: study protocol for a randomized controlled trial
Sarah Michiels, Willem De Hertogh, Steven Truijen, Paul Van de Heyning
Feasibility and pilot study of the effects of microfinance on mortality and nutrition in children under five amongst the very poor in India: study protocol for a cluster randomized controlled trial
Shalini Ojha, Lisa Szatkowski, Ranjeet Sinha, Gil Yaron, Andrew Fogarty, Stephen Allen, Sunil Choudhary, Alan R Smyth
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
Activity Begins in Childhood (ABC) – inspiring healthy active behaviour in preschoolers: study protocol for a cluster randomized controlled trial
Kristi B Adamo, Nick Barrowman, Patti Jean Naylor, Sanni Yaya, Alysha Harvey, Kimberly P Grattan, Gary S Goldfield
Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions
Mary J De Silva, Erica Breuer, Lucy Lee, Laura Asher, Neerja Chowdhary, Crick Lund, Vikram Patel
A pilot study to assess the feasibility and impact of a brief motivational intervention on problem drug and alcohol use in adult mental health inpatient units: study protocol for a randomized controlled trial
Hermine L Graham, Max Birchwood, Emma Griffith, Nick Freemantle, Paul McCrone, Chrysi A Stefanidou, Kathryn Walsh, Latoya Clarke, Arsal Rana, Alex Copello
Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial
Anthony K Mbonye, Pascal Magnussen, Clare IR Chandler, Kristian S Hansen, Sham Lal, Bonnie Cundill, Caroline A Lynch, Siân E Clarke
Rationale and design of the research project of the South Florida Center for the Reduction of Cancer Health Disparities (SUCCESS): study protocol for a randomized controlled trial
Olveen Carrasquillo, Sheila McCann, Antony Amofah, Larry Pierre, Brendaly Rodriguez, Yisel Alonzo, Kumar Ilangovan, Martha Gonzalez, Dinah Trevil, Margaret M Byrne, Tulay Koru-Sengul, Erin Kobetz
The effect of primary delivery of the anterior compared with the posterior shoulder on perineal trauma: a study protocol for a randomized controlled trial
Hanne Willer, Anna JM Aabakke, Lone Krebs
Baclofen for stroke patients with persistent hiccups: a randomized, double-blind, placebo-controlled trial
Cuie Zhang, Ruifen Zhang, Shuangyan Zhang, Meiling Xu, Shuyan Zhang
A pilot randomised controlled trial of a Telehealth intervention in patients with chronic obstructive pulmonary disease: challenges of clinician-led data collection
Claire L Bentley, Gail A Mountain, Jill Thompson, Deborah A Fitzsimmons, Kinga Lowrie, Stuart G Parker, Mark S Hawley
Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials
Katie Gillies, Glyn Elwyn, Jonathan Cook
The percutaneous coronary intervention prior to transcatheter aortic valve implantation (ACTIVATION) trial: study protocol for a randomized controlled trial
Muhammed Zeeshan Khawaja, Duolao Wang, Stuart Pocock, Simon Robert Redwood, Martyn Rhys Thomas
Grip on challenging behavior: process evaluation of the implementation of a care program
Sandra A Zwijsen, Martin Smalbrugge, Jan A Eefsting, Debby L Gerritsen, Cees MPM Hertogh, Anne Margriet Pot
Automated real-time text messaging as a means for rapidly identifying acute stroke patients for clinical trials
Kati Jegzentis, Tim Nowe, Peter Brunecker, Matthias Endres, Bernd Haferkorn, Christoph Ploner, Jens Steinbrink, Gerhard Jan Jungehulsing
Computer-assisted cognitive-behavioral therapy for adolescent depression in primary care clinics in Santiago, Chile (YPSA-M): study protocol for a randomized controlled trial
Vania Martínez, Pablo Martínez, Paul A Vöhringer, Ricardo Araya, Graciela Rojas
Selective internal radiotherapy (SIRT) versus transarterial chemoembolization (TACE) for the treatment of intrahepatic cholangiocellular carcinoma (CCC): study protocol for a randomized controlled trial
Roman Kloeckner, Christian Ruckes, Kai Kronfeld, Marcus Alexander Wörns, Arndt Weinmann, Peter Robert Galle, Hauke Lang, Gerd Otto, Waltraud Eichhorn, Mathias Schreckenberger, Christoph Dueber, Michael Bernhard Pitton
Community-applied research of a traditional Chinese medicine rehabilitation scheme on Broca’s aphasia after stroke: study protocol for a randomized controlled trial
Jing Tao, Yunhua Fang, Zhenkai Wu, Ting Rao, Yusheng Su, Lili Lin, Wei Liu, Jinsong Wu, Shanli Yang, Guohua Zheng, Lidian Chen
Effectiveness of strengthened stimulation during acupuncture for the treatment of allergic rhinitis: study protocol for a randomized controlled trial
Qing Chen, Qinxiu Zhang, Luyun Jiang, Xinrong Li, Yang Liu, Yan Xie, Shan Mu, Ying Liu, Xiaopei Wang, Yunzhi Yu, Min Li
An approach to trial design and analysis in the era of non-proportional hazards of the treatment effect
Patrick Royston, Mahesh KB Parmar
Evaluation of a nurse mentoring intervention to family caregivers in the management of delirium after cardiac surgery (MENTOR_D): a study protocol for a randomized controlled pilot trial
Tanya Mailhot, Sylvie Cossette, Anne Bourbonnais, José Côté, André Denault, Marie-Claude Côté, Yoan Lamarche, Marie-Claude Guertin
Assessing the external validity of a randomized controlled trial of anthelminthics in mothers and their children in Entebbe, Uganda
James D Millard, Lawrence Muhangi, Moses Sewankambo, Juliet Ndibazza, Alison M Elliott, Emily L Webb
The DARS (Dopamine Augmented Rehabilitation in Stroke) trial: protocol for a randomised controlled trial of Co-careldopa treatment in addition to routine NHS occupational and physical therapy after stroke
Bipin B Bhakta, Suzanne Hartley, Ivana Holloway, J Alastair Couzens, Gary A Ford, David Meads, Catherine M Sackley, Marion F Walker, Sharon P Ruddock, Amanda J Farrin
Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial
Roger Olofsson, Lars Ny, Malin Sternby Eilard, Magnus Rizell, Christian Cahlin, Ulrika Stierner, Ulf Lönn, Johan Hansson, Ingrid Ljuslinder, Lotta Lundgren, Gustav Ullenhag, Jens Folke Kiilgaard, Jonas Nilsson, Per Lindnér
Feasibility of a randomized controlled trial of functional strength training for people between six months and five years after stroke: FeSTivaLS trial
Kathryn Mares, Jane Cross, Allan Clark, Susan Vaughan, Garry R Barton, Fiona Poland, Kate McGlashan, Martin Watson, Phyo K Myint, Marie-Luce O’Driscoll, Valerie M Pomeroy
Training recruiters to randomized trials to facilitate recruitment and informed consent by exploring patients' treatment preferences
Nicola Mills, Jane M Blazeby, Freddie C Hamdy, David E Neal, Bruce Campbell, Caroline Wilson, Sangeetha Paramasivan, Jenny L Donovan
Effect evaluation of two types of dementia-specific case conferences in German nursing homes (FallDem) using a stepped-wedge design: study protocol for a randomized controlled trial
Sven Reuther, Daniela Holle, Ines Buscher, Olga Dortmann, René Müller, Sabine Bartholomeyczik, Margareta Halek
Intratympanic gentamicin treatment for Ménière’s disease: a randomized, double-blind, placebo-controlled trial on dose efficacy - results of a prematurely ended study
Hendrik G Bremer, Ingrid van Rooy, Bas Pullens, Carla Colijn, Inge Stegeman, Hester J van der Zaag-Loonen, Peter Paul van Benthem, Sjaak F L Klis, Wilko Grolman, Tjasse D Bruintjes
Left ventricular remodeling after acute myocardial infarction: the influence of viability and revascularization - an echocardiographic substudy of the VIAMI-trial
Ramon B van Loon, Gerrit Veen, Otto Kamp, Leo HB Baur, Albert C van Rossum
Reducing depression during the menopausal transition: study protocol for a randomised controlled trial
Osvaldo P Almeida, Kylie Marsh, Leon Flicker, Martha Hickey, Andrew Ford, Moira Sim
Multifamily psychoeducation for improvement of mental health among relatives of patients with major depressive disorder lasting more than one year: study protocol for a randomized controlled trial
Fujika Katsuki, Hiroshi Takeuchi, Norio Watanabe, Nao Shiraishi, Tohru Maeda, Yosuke Kubota, Masako Suzuki, Atsurou Yamada, Tatsuo Akechi
A multicenter, randomized, open-labeled study to steer immunosuppressive and antiviral therapy by measurement of virus (CMV, ADV, HSV)-specific T cells in addition to determination of trough levels of immunosuppressants in pediatric kidney allograft recipients (IVIST01-trial): study protocol for a randomized controlled trial
Thurid Ahlenstiel-Grunow, Armin Koch, Anika Großhennig, Cornelia Frömke, Martina Sester, Urban Sester, Christoph Schröder, Lars Pape
Phototherapy 660 nm for the prevention of radiodermatitis in breast cancer patients receiving radiation therapy: study protocol for a randomized controlled trial
Marina Moreira Costa, Sidney Benedito Silva, Ana Luiza Pereira Quinto, Priscilla Furtado Souza Pasquinelli, Vanessa de Queiroz dos Santos, Gabriela de Cássia Santos, Daniela Francescato Veiga
Prevention of post-mastectomy neuropathic pain with memantine: study protocol for a randomized controlled trial
Gisèle Pickering, Véronique Morel, Dominique Joly, Christine Villatte, Delphine Roux, Claude Dubray, Bruno Pereira
Relating therapy for voices (the R2V study): study protocol for a pilot randomized controlled trial
Mark Hayward, Clara Strauss, Leanne Bogen-Johnston
Recruitment of young adults into a randomized controlled trial of weight gain prevention: message development, methods, and cost
Deborah F Tate, Jessica G LaRose, Leah P Griffin, Karen E Erickson, Erica F Robichaud, Letitia Perdue, Mark A Espeland, Rena R Wing
The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials
Conor Duggan, Glenys Parry, Mary McMurran, Kate Davidson, Jane Dennis
Understanding of chest pain in microvascular disease proved by cardiac magnetic resonance image (UMPIRE): study protocol for a randomized controlled trial
Sung-Ji Park, Jin Joo Park, Dong-Ju Choi, Eun Ju Chun, Sang Il Choi, Sung Mok Kim, Shin Yi Jang, Soyeon Ahn, Yeon Hyeon Choe
Comparing exercise interventions to increase persistence with physical exercise and sporting activity among people with hypertension or high normal blood pressure: study protocol for a randomised controlled trial
Chris Fife-Schaw, Simon de Lusignan, Joe Wainwright, Hannah Sprake, Suzannah Laver, Victoria Heald, Julian Orton, Matt Prescott, Helen Carr, Mark O’Neill
Impact of oral melatonin on critically ill adult patients with ICU sleep deprivation: study protocol for a randomized controlled trial
Huawei Huang, Li Jiang, Ling Shen, Guobin Zhang, Bo Zhu, Jiajia Cheng, Xiuming Xi
Negative pressure wound therapy versus standard wound care in chronic diabetic foot wounds: study protocol for a randomized controlled trial
Dörthe Seidel, Tim Mathes, Rolf Lefering, Martin Storck, Holger Lawall, Edmund A M Neugebauer
Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial
Gloria Y Yeh, Peter M Wayne, Daniel Litrownik, David H Roberts, Roger B Davis, Marilyn L Moy
Community-based scheduled screening and treatment of malaria in pregnancy for improved maternal and infant health in The Gambia, Burkina Faso and Benin: study protocol for a randomized controlled trial
Susana Scott, Petra F Mens, Halidou Tinto, Alain Nahum, Esmée Ruizendaal, Franco Pagnoni, Koen Peeters Grietens, Lindsay Kendall, Kalifa Bojang, Henk Schallig, Umberto D’Alessandro
Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial
Alice S Forster, Caroline Burgess, Lisa McDermott, Alison J Wright, Hiten Dodhia, Mark Conner, Jane Miller, Caroline Rudisill, Victoria Cornelius, Martin C Gulliford
Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial
Juliana Martinez-Atienza, Clara Rosso-Fernández, Cristina Roca, Teresa A Aydillo, Joan Gavaldà, Asunción Moreno, Jose M Montejo, Julian Torre-Cisneros, M Carmen Fariñas, Jesus Fortun, Nuria Sabé, Patricia Muñoz, Marino Blanes-Julia, Alejandro Suárez-Benjumea, Francisco López-Medrano, Pilar Pérez-Romero, Elisa Cordero
Effectiveness of the population-based Check your health preventive programme conducted in primary care with 4 years follow-up [the CORE trial]: study protocol for a randomised controlled trial
Helle Terkildsen Maindal, Henrik Støvring, Annelli Sandbaek
MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: study protocol for a randomized controlled trial
Puck SS Fransen, Debbie Beumer, Olvert A Berkhemer, Lucie A van den Berg, Hester Lingsma, Aad van der Lugt, Wim H van Zwam, Robert J van Oostenbrugge, Yvo BWEM Roos, Charles B Majoie, Diederik WJ Dippel
Meta-analysis of randomized phase II trials to inform subsequent phase III decisions
Danielle L Burke, Lucinda J Billingham, Alan J Girling, Richard D Riley
Effect of fluid and dietary sodium restriction in the management of patients with heart failure and preserved ejection fraction: study protocol for a randomized controlled trial
Karina SM d’Almeida, Eneida R Rabelo-Silva, Gabriela C Souza, Melina M Trojahn, Sofia LS Barilli, Jessica V Mansson, Andreia Biolo, Luis EP Rohde, Nadine Clausell, Luís Beck-da-Silva
Use of ivabradine and atorvastatin in emergent orthopedic lower limb surgery and computed tomography coronary plaque imaging and novel biomarkers of cardiovascular stress and lipid metabolism for the study and prevention of perioperative myocardial infarction: study protocol for a randomized controlled trial
Nima Rudd, Ivan Subiakto, Muhammad Asrar ul Haq, Vivek Mutha, William J Van Gaal
Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled trial
Berglind Libungan, Geir Hirlekar, Per Albertsson
Evaluation of a standardized treatment regimen of anti-tuberculosis drugs for patients with multi-drug-resistant tuberculosis (STREAM): study protocol for a randomized controlled trial
Andrew J Nunn, ID Rusen, Armand Van Deun, Gabriela Torrea, Patrick PJ Phillips, Chen-Yuan Chiang, S Bertel Squire, Jason Madan, Sarah K Meredith
Using mixed methods to evaluate efficacy and user expectations of a virtual reality–based training system for upper-limb recovery in patients after stroke: a study protocol for a randomised controlled trial
Corina Schuster-Amft, Kynan Eng, Isabelle Lehmann, Ludwig Schmid, Nagisa Kobashi, Irène Thaler, Martin L Verra, Andrea Henneke, Sandra Signer, Michael McCaskey, Daniel Kiper
A combination of ascorbic acid and α-tocopherol to test the effectiveness and safety in the fragile X syndrome: study protocol for a phase II, randomized, placebo-controlled trial
Yolanda de Diego-Otero, Rocio Calvo-Medina, Carolina Quintero-Navarro, Lourdes Sánchez-Salido, Francisco García-Guirado, Ignacio del Arco-Herrera, Isabel Fernández-Carvajal, Teresa Ferrando-Lucas, Rafaela Caballero-Andaluz, Lucia Pérez-Costillas
Acupuncture in subjects with cold hands sensation: study protocol for a randomized controlled trial
Jung-Chul Seo, Hyun-jong Lee, Min-Ah Kwak, Sung-Hoon Park, ImHee Shin, Woo-Sung Yun, Kihyuk Park
Deep brain stimulation of the basolateral amygdala for treatment-refractory combat post-traumatic stress disorder (PTSD): study protocol for a pilot randomized controlled trial with blinded, staggered onset of stimulation
Ralph J Koek, Jean-Philippe Langevin, Scott E Krahl, Hovsep J Kosoyan, Holly N Schwartz, James WY Chen, Rebecca Melrose, Mark J Mandelkern, David Sultzer
Efficacy of two different self-expanding nitinol stents for atherosclerotic femoropopliteal arterial disease (SENS-FP trial): study protocol for a randomized controlled trial
Sang Ho Park, Seung Woon Rha, Cheol Ung Choi, Eung Ju Kim, Dong Joo Oh, Yun Hyeong Cho, Woong Gil Choi, Seung Jin Lee, Yong Hoon Kim, Seung Hyuk Choi, Won Ho Kim, Ki Chang Kim, Jang Hyun Cho, Joo Han Kim, Sang Min Kim, Jang Ho Bae, Jung Min Bong, Won Yu Kang, Ju Yeol Baek, Jae Bin Seo, Woo Young Chung, Mahn Won Park, Sung Ho Her, Jon Suh, Min Woong Kim, Yeo Joo Kim, Hwan Jun Choi, Jae Wan Soh
Stop the pain: study protocol for a randomized-controlled trial
Petra Warschburger, Claudia Calvano, Sebastian Becker, Michael Friedt, Christian Hudert, Carsten Posovszky, Maike Schier, Karl Wegscheider
The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial
Brian C Focht, Alexander R Lucas, Elizabeth Grainger, Christina Simpson, Jennifer M Thomas-Ahner, Steven K Clinton
Influence of early goal-directed therapy using arterial waveform analysis on major complications after high-risk abdominal surgery: study protocol for a multicenter randomized controlled superiority trial
Leonard Montenij, Eric de Waal, Michael Frank, Paul van Beest, Ardine de Wit, Cas Kruitwagen, Wolfgang Buhre, Thomas Scheeren
Effectiveness of patient feedback as an educational intervention to improve medical student consultation (PTA Feedback Study): study protocol for a randomized controlled trial
Michelle Mei Yee Lai, Noel Roberts, Jenepher Martin
Cross-sectional analysis of the reporting of continuous outcome measures and clinical significance of results in randomized trials of non-pharmacological interventions
Tammy C Hoffmann, Sarah T Thomas, Paul Ng Hung Shin, Paul P Glasziou
Correcting for multiple-testing in multi-arm trials: is it necessary and is it done?
James M S Wason, Lynne Stecher, Adrian P Mander
Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial
Simone Vigod, Cindy-Lee Dennis, Zafiris Daskalakis, Kellie Murphy, Joel Ray, Tim Oberlander, Sarah Somerton, Neesha Hussain-Shamsy, Daniel Blumberger
The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial
Elham Emami, Phan The Huy Nguyen, Fernanda R Almeida, Jocelyne S Feine, Igor Karp, Gilles Lavigne, Nelly Huynh
The INTERVAL trial to determine whether intervals between blood donations can be safely and acceptably decreased to optimise blood supply: study protocol for a randomised controlled trial
Carmel Moore, Jennifer Sambrook, Matthew Walker, Zoe Tolkien, Stephen Kaptoge, David Allen, Susan Mehenny, Jonathan Mant, Emanuele Di Angelantonio, Simon G Thompson, Willem Ouwehand, David J Roberts, John Danesh
‘On Your Feet to Earn Your Seat’, a habit-based intervention to reduce sedentary behaviour in older adults: study protocol for a randomized controlled trial
Benjamin Gardner, Ingela Thuné-Boyle, Steve Iliffe, Kenneth R Fox, Barbara J Jefferis, Mark Hamer, Nick Tyler, Jane Wardle
A multicentre non-blinded randomised controlled trial to assess the impact of regular early specialist symptom control treatment on quality of life in malignant mesothelioma (RESPECT-MESO): study protocol for a randomised controlled trial
Samal Gunatilake, Fraser JH Brims, Carole Fogg, Iain Lawrie, Nick Maskell, Karen Forbes, Najib Rahman, Steve Morris, Reuben Ogollah, Stephen Gerry, Mick Peake, Liz Darlison, Anoop J Chauhan
Participants’ understanding of a randomized controlled trial (RCT) through informed consent procedures in the RCT for breast cancer screening, J-START
Yoko Narikawa Shiono, Ying-Fang Zheng, Masahiro Kikuya, Masaaki Kawai, Takanori Ishida, Shinichi Kuriyama, Noriaki Ohuchi
Oral corticosteroid use for clinical and cost-effective symptom relief of sore throat: study protocol for a randomized controlled trial
Johanna Cook, Gail Hayward, Matthew Thompson, Alastair D Hay, Michael Moore, Paul Little, Kim Harman, Jane Wolstenholme, Rafael Perera, Merryn Voysey, Julie Allen, Maria Breen, Carl Heneghan
Linked publications from a single trial: a thread of evidence
Douglas G Altman, Curt D Furberg, Jeremy M Grimshaw, Daniel R Shanahan
The REFLO-STEMI trial comparing intracoronary adenosine, sodium nitroprusside and standard therapy for the attenuation of infarct size and microvascular obstruction during primary percutaneous coronary intervention: study protocol for a randomised controlled trial
Sheraz A Nazir, Jamal N Khan, Islam Z Mahmoud, John P Greenwood, Daniel J Blackman, Vijay Kunadian, Martin Been, Keith R Abrams, Robert Wilcox, AA Jennifer Adgey, Gerry P McCann, Anthony H Gershlick
Early non-invasive ventilation for acute respiratory failure in immunocompromised patients (IVNIctus): study protocol for a multicenter randomized controlled trial
Virginie Lemiale, Matthieu Resche-Rigon, Elie Azoulay
Role of vitamin D3 in Treatment of Lumbar Disc Herniation—Pain and Sensory Aspects: Study Protocol for a Randomized Controlled Trial
Mahsa Sedighi, Ali Haghnegahdar
Detailed statistical analysis plan for the Danish Palliative Care Trial (DanPaCT)
Anna Thit Johnsen, Morten Aagaard Petersen, Christian Gluud, Jane Lindschou, Peter Fayers, Per Sjøgren, Lise Pedersen, Mette Asbjoern Neergaard, Tove Bahn Vejlgaard, Anette Damkier, Jan Bjoern Nielsen, Annette S Strömgren, Irene J Higginson, Mogens Groenvold
Accounting for center in the Early External Cephalic Version trials: an empirical comparison of statistical methods to adjust for center in a multicenter trial with binary outcomes
Angela Reitsma, Rong Chu, Julia Thorpe, Sarah McDonald, Lehana Thabane, Eileen Hutton
The challenges of long-term follow-up data collection in non-commercial, academically-led breast cancer clinical trials: the UK perspective
Lucy S Kilburn, Jane Banerji, Judith M Bliss
Feasibility study of the effects of art as a creative engagement intervention during stroke rehabilitation on improvement of psychosocial outcomes: study protocol for a single blind randomized controlled trial: the ACES study
Jacqui H Morris, Chris Kelly, Madalina Toma, Thilo Kroll, Sara Joice, Gillian Mead, Peter Donnan, Brian Williams
Predictors of clinical trial data sharing: exploratory analysis of a cross-sectional survey
Vinay K Rathi, Kelly M Strait, Cary P Gross, Iain Hrynaszkiewicz, Steven Joffe, Harlan M Krumholz, Kristina Dzara, Joseph S Ross
Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency
Amelie Elsäßer, Jan Regnstrom, Thorsten Vetter, Franz Koenig, Robert James Hemmings, Martina Greco, Marisa Papaluca-Amati, Martin Posch
Efficacy and safety of the C-Qur™ Film Adhesion Barrier for the prevention of surgical adhesions (CLIPEUS Trial): study protocol for a randomized controlled trial
Martijn WJ Stommel, Chema Strik, Richard PG ten Broek, Harry van Goor
Update of the Preventive Antibiotics in Stroke Study (PASS): statistical analysis plan
Willeke F Westendorp, Jan-Dirk Vermeij, Diederik W J Dippel, Marcel G W Dijkgraaf, Tom van der Poll, Jan M Prins, Frederique H Vermeij, Yvo B W E M Roos, Matthijs C Brouwer, Aeilko H Zwinderman, Diederik van de Beek, Paul J Nederkoorn
Early intervention to protect the mother-infant relationship following postnatal depression: study protocol for a randomised controlled trial
Jeannette Milgrom, Charlene Holt
Effects of varenicline and cognitive bias modification on neural response to smoking-related cues: study protocol for a randomized controlled study
Angela S Attwood, Tim Williams, Sally Adams, Francis J McClernon, Marcus R Munafò
Effect of percutaneous assisted approach on functional rehabilitation for total hip replacement compared to anterolateral approach: study protocol for a randomized controlled trial
Claudia Hendrickx, Willem De Hertogh, Ulrike Van Daele, Peter Mertens, Gaetane Stassijns
Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial
Chris Bonell, Elizabeth Allen, Deborah Christie, Diana Elbourne, Adam Fletcher, Richard Grieve, Rosa LeGood, Anne Mathiot, Stephen Scott, Meg Wiggins, Russell M Viner
Selenium Treatment and Chagasic Cardiopathy (STCC): study protocol for a double-blind randomized controlled trial
Pedro Emmanuel Alvarenga Americano do Brasil, Andréa Pereira de Souza, Alejandro Marcel Hasslocher-Moreno, Sérgio Salles Xavier, Sonia Regina Lambert Passos, Maria de Fátima Ramos Moreira, Marília Santini de Oliveira, Gilberto Marcelo Sperandio da Silva, Roberto Magalhães Saraiva, Claudia Santos de Aguiar Cardoso, Andréa Silvestre de Sousa, Mauro Felippe Felix Mediano, Maria da Gloria Bonecini de Almeida, Otacílio da Cruz Moreira, Constança Britto, Tania Cremonini de Araújo-Jorge
Comparing the effectiveness of the 0.018-inch versus the 0.022-inch bracket slot system in orthodontic treatment: study protocol for a randomized controlled trial
Ahmed MF El-Angbawi, David R Bearn, Grant T McIntyre
Early intervention program reduces stress in parents of preterms during childhood, a randomized controlled trial
Inger Pauline Landsem, Bjørn Helge Handegård, Jorunn Tunby, Stein Erik Ulvund, John A Rønning
Tooth whitening with hydrogen peroxide in adolescents: study protocol for a randomized controlled trial
Marcelo Mendes Pinto, Camila Haddad Leal de Godoy, Carolina Carvalho Bortoletto, Silvia Regina Garcia Olivan, Lara Jansiski Motta, Olga Maria Altavista, Katia Lumi, Ana Paula Taboada Sobral, Sandra Kalil Bussadori
Effectiveness of De Qi during acupuncture for the treatment of tinnitus: study protocol for a randomized controlled trial
Hui Xie, Xinrong Li, Jiaqin Lai, Yanan Zhou, Caiying Wang, Jiao Liang
Sleep to lower elevated blood pressure: study protocol for a randomized controlled trial
Emer R McGrath, Colin A Espie, Andrew W Murphy, John Newell, Alice Power, Sarah Madden, Molly Byrne, Martin J O’Donnell
The Tinnitus Retraining Therapy Trial (TRTT): study protocol for a randomized controlled trial
Roberta W Scherer, Craig Formby, Susan Gold, Sue Erdman, Charles Rodhe, Michele Carlson, Dave Shade, Melanie Tucker, Lee McCaffrey Sensinger, Gordon Hughes, George S Conley, Naomi Downey, Cynthia Eades, Margaret Jylkka, Ada Haber-Perez, Courtney Harper, Shoshannah Kantor Russell, Benigno Sierra-Irizarry, Mark Sullivan
The DiReCT study - improving recruitment into clinical trials: a mixed methods study investigating the ethical acceptability, feasibility and recruitment yield of the cohort multiple randomised controlled trials design
David A Richards, Sarah Ross, Sarah Robens, Gunilla Borglin
Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities
Peter Bower, Valerie Brueton, Carrol Gamble, Shaun Treweek, Catrin Tudur Smith, Bridget Young, Paula Williamson
Effect of acupuncture on patients with insomnia: study protocol for a randomized controlled trial
Kyung-Hun Han, Sang-Young Kim, Sun-Yong Chung
Effectiveness of group reminiscence for improving wellbeing of institutionalized elderly adults: study protocol for a randomized controlled trial
Andrea Gaggioli, Chiara Scaratti, Luca Morganti, Marco Stramba-Badiale, Monica Agostoni, Chiara A. M. Spatola, Enrico Molinari, Pietro Cipresso, Giuseppe Riva
Acupressure for agitation in nursing home residents with dementia: study protocol for a randomized controlled trial
Rick Yiu Cho Kwan, Mason Chin Pang Leung, Claudia Kam Yuk Lai
Process evaluation of a multicomponent dyadic intervention study with exercise and support for people with dementia and their family caregivers
Anna-Eva Prick, Jacomine de Lange, Netta van ‘t Leven, Anne Margriet Pot
A novel cognitive behaviour therapy for bipolar disorders (Think Effectively About Mood Swings or TEAMS): study protocol for a randomized controlled trial
Warren Mansell, Sara Tai, Alexandra Clark, Savas Akgonul, Graham Dunn, Linda Davies, Heather Law, Richard Morriss, Neil Tinning, Anthony P Morrison
Hydroxychloroquine in patients with inflammatory and erosive osteoarthritis of the hands (OA TREAT): study protocol for a randomized controlled trial
Jacqueline Detert, Pascal Klaus, Joachim Listing, Vera Höhne-Zimmer, Tanja Braun, Siegfried Wassenberg, Rolf Rau, Frank Buttgereit, Gerd R. Burmester
Integrated treatment of first episode psychosis with online training (e-learning): study protocol for a randomised controlled trial
Sara Barbeito, Patricia Vega, Sonia Ruiz de Azua, Vicent Balanza- Martinez, Francesc Colom, Esther Lorente, Ana Luengo, Ester Cerrillo, José Manuel Crespo, Ana González Pinto
Implementing comprehensive prevention of mother-to-child transmission and HIV prevention for South African couples: study protocol for a randomized controlled trial
Deborah Jones, Karl Peltzer, Stephen M Weiss, Sibusiso Sifunda, Ntabozuko Dwane, Shandir Ramlagan, Ryan Cook, Gladys Matseke, Vincent Maduna, Andrew Spence
Eligibility determination for clinical trials: development of a case review process at a chiropractic research center
Robert D. Vining, Stacie A. Salsbury, Katherine A. Pohlman
Cerclage outcome by the type of suture material (COTS): study protocol for a pilot and feasibility randomised controlled trial
Fidan Israfil-Bayli, Philip Toozs-Hobson, Christoph Lees, Mark Slack, Khaled Ismail
Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial
Kate M Wilkinson, Anton Krige, Sarah G Brearley, Steven Lane, Michael Scott, Anthony C Gordon, Gordon L Carlson
The effect of work-based mentoring on patient outcome in musculoskeletal physiotherapy: study protocol for a randomised controlled trial
Aled L Williams, Ceri J. Phillips, Alan Watkins, Alison B. Rushton
Impact of remote ischemic preconditioning preceding coronary artery bypass grafting on inducing neuroprotection (RIPCAGE): study protocol for a randomized controlled trial
Hrvoje Gasparovic, Tomislav Kopjar, Milan Rados, Alan Anticevic, Marko Rados, Branko Malojcic, Visnja Ivancan, Tea Fabijanic, Maja Cikes, Davor Milicic, Vladimir Gasparovic, Bojan Biocina
Palliative radiotherapy in addition to self-expanding metal stent for improving dysphagia and survival in advanced oesophageal cancer (ROCS: Radiotherapy after Oesophageal Cancer Stenting): study protocol for a randomized controlled trial
Douglas Adamson, Jane Blazeby, Annmarie Nelson, Chris Hurt, Lisette Nixon, Jim Fitzgibbon, Tom Crosby, John Staffurth, Mim Evans, Noreen Hopewell Kelly, David Cohen, Gareth Griffiths, Anthony Byrne
Low-dose intravenous immunoglobulin treatment for complex regional pain syndrome (LIPS): study protocol for a randomized controlled trial
Andreas Goebel, Nicholas Shenker, Nick Padfield, Karim Shoukrey, Candida McCabe, Mick Serpell, Mark Sanders, Caroline Murphy, Amaka Ejibe, Holly Milligan, Joanna Kelly, Gareth Ambler
The COMmunity of Practice And Safety Support (COMPASS) total worker health™ study among home care workers: study protocol for a randomized controlled trial
Ryan Olson, Diane Elliot, Jennifer Hess, Sharon Thompson, Kristy Luther, Brad Wipfli, Robert Wright, Annie Mancini Buckmaster
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
Bare metal stent versus paclitaxel eluting stent for intermediate length femoropopliteal arterial lesions (BATTLE trial): study protocol for a randomized controlled trial
Yann Gouëffic, Adrien Kaladji, Béatrice Guyomarch, Carine Montagne, Damien Fairier, Simon Gestin, Valéry-Pierre Riche, Pierre Alexandre Vent, Philippe Chaillou, Alain Costargent, Philippe Patra
Effectiveness of Chinese massage therapy (Tui Na) for chronic low back pain: study protocol for a randomized controlled trial
Mingxiao Yang, Yue Feng, Hong Pei, Shufang Deng, Minyu Wang, Xianjun Xiao, Hui Zheng, Zhenhong Lai, Jiao Chen, Xiang Li, Xiaoguo He, Fanrong Liang
Mechanochemical endovenous ablation versus radiofrequency ablation in the treatment of primary small saphenous vein insufficiency (MESSI trial): study protocol for a randomized controlled trial
Doeke Boersma, Ramon RJP van Eekeren, Hans JC Kelder, Debora AB Werson, Suzanne Holewijn, Michiel A Schreve, Michel MPJ Reijnen, Jean Paul PM de Vries
The addition of fluoxetine to cognitive behavioural therapy for youth depression (YoDA-C): study protocol for a randomised control trial
Christopher G Davey, Andrew M Chanen, Sue M Cotton, Sarah E Hetrick, Melissa J Kerr, Michael Berk, Olivia M Dean, Kally Yuen, Mark Phelan, Aswin Ratheesh, Miriam R Schäfer, G Paul Amminger, Alexandra G Parker, Danijela Piskulic, Susy Harrigan, Andrew J Mackinnon, Ben J Harrison, Patrick D McGorry
Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
Jo Rick, Jonathan Graffy, Peter Knapp, Nicola Small, David J. Collier, Sandra Eldridge, Anne Kennedy, Chris Salisbury, Shaun Treweek, David Torgerson, Paul Wallace, Vichithranie Madurasinghe, Adwoa Hughes-Morley, Peter Bower
Manualised Cognitive Remediation Therapy for adult obesity: study protocol for a randomised controlled trial
Jayanthi Raman, Phillipa Hay, Evelyn Smith
The Global Consortium for Drug-resistant Tuberculosis Diagnostics (GCDD): design of a multi-site, head-to-head study of three rapid tests to detect extensively drug-resistant tuberculosis
Naomi Hillery, Erik J Groessl, Andre Trollip, Donald Catanzaro, Lynn Jackson, Timothy C Rodwell, Richard S Garfein, S-Y Grace Lin, Kathleen Eisenach, Theodore G Ganiats, Daniel Park, Faramarz Valafar, Camilla Rodrigues, Valeriu Crudu, Thomas C Victor, Antonino Catanzaro
Traditional Chinese medicine for stable angina pectoris via TCM pattern differentiation and TCM mechanism: study protocol of a randomized controlled trial
Zhe Zhang, Fan Zhang, Yang Wang, Yi Du, Huiyong Zhang, Dezhao Kong, Yue Liu, Guanlin Yang
Effects of vildagliptin compared with glibenclamide on glucose variability after a submaximal exercise test in patients with type 2 diabetes: study protocol for a randomized controlled trial, DIABEX VILDA
Aline Fofonka, Jorge Pinto Ribeiro, Karina Rabello Casali, Beatriz D Schaan
VITamin D supplementation in renAL transplant recipients (VITALE): a prospective, multicentre, double-blind, randomized trial of vitamin D estimating the benefit and safety of vitamin D3 treatment at a dose of 100,000 UI compared with a dose of 12,000 UI in renal transplant recipients: study protocol for a double-blind, randomized, controlled trial
Marie Courbebaisse, Corinne Alberti, Sandra Colas, Dominique Prié, Jean-Claude Souberbielle, Jean-Marc Treluyer, Eric Thervet
A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery
Stéphane V. Berdah, Christophe Mariette, Christine Denet, Yves Panis, Christophe Laurent, Eddy Cotte, Nöel Huten, Eliane Le Peillet Feuillet, Jean-Jacques Duron
Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study
Paul Gillard, Didier Giet, Stéphane Heijmans, Mamadou Dramé, Karl Walravens, François Roman
Efficacy of a hybrid online training for panic symptoms and agoraphobia: study protocol for a randomized controlled trial
Lara Ebenfeld, Stefan Kleine Stegemann, Dirk Lehr, David Daniel Ebert, Hooria Jazaieri, Wouter van Ballegooijen, Burkhardt Funk, Heleen Riper, Matthias Berking
The effects of progressive resistance training combined with a whey-protein drink and vitamin D supplementation on glycaemic control, body composition and cardiometabolic risk factors in older adults with type 2 diabetes: study protocol for a randomized controlled trial
Robin M Daly, Eliza G Miller, David W Dunstan, Deborah A Kerr, Vicky Solah, David Menzies, Caryl A Nowson
Control of fluid balance guided by body composition monitoring in patients on peritoneal dialysis (COMPASS): study protocol for a randomized controlled trial
Seon Ha Baek, Kook-Hwan Oh, Sejoong Kim, Dong Ki Kim, Kwon-Wook Joo, Yun Kyu Oh, Byoung Geun Han, Jae Hyun Chang, Wookyung Chung, Yon Su Kim, Ki Young Na
Coronary Artery Disease Evaluation in Rheumatoid Arthritis (CADERA): study protocol for a randomized controlled trial
Bara Erhayiem, Sue Pavitt, Paul Baxter, Jacqueline Andrews, John P Greenwood, Maya H Buch, Sven Plein
Characteristics of clinical trial websites: information distribution between ClinicalTrials.gov and 13 primary registries in the WHO registry network
Daisuke Ogino, Kunihiko Takahashi, Hajime Sato
Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial
Jianhui Qu, Zujiang Yu, Qin Li, Yongping Chen, Dedong Xiang, Lin Tan, Chunliang Lei, Wenlin Bai, Hongyan Li, Qinghua Shang, Liang Chen, Xiaoyu Hu, Wei Lu, Zhiqin Li, Da Chen, Xiaodong Wang, Changjiang Zhang, Guangming Xiao, Xun Qi, Jing Chen, Li Zhou, Guofeng Chen, Yonggang Li, Zhen Zeng, Guanghua Rong, Zheng Dong, Yan Chen, Min Lou, Chunping Wang, Yinying Lu, Cuihong Zhang, Yongping Yang
MObile Technology for Improved Family Planning: update to randomised controlled trial protocol
Chris Smith, Thoai D Ngo, Phil Edwards, Caroline Free
Endorsement for improving the quality of reports on randomized controlled trials of traditional medicine journals in Korea: a systematic review
Jiae Choi, Ji Hee Jun, Byoung Kab Kang, Kun Hyung Kim, Myeong Soo Lee
Photodynamic therapy as a novel treatment for halitosis in adolescents: study protocol for a randomized controlled trial
Rubia Garcia Lopes, Camila Haddad Leal de Godoy, Alessandro Melo Deana, Maria Eugenia Simões Onofre de Santi, Renato Araujo Prates, Cristiane Miranda França, Kristianne Porta Santos Fernandes, Raquel Agnelli Mesquita-Ferrari, Sandra Kalil Bussadori
Treatment of electroencephalographic status epilepticus after cardiopulmonary resuscitation (TELSTAR): study protocol for a randomized controlled trial
Barry J Ruijter, Michel JAM van Putten, Janneke Horn, Michiel J Blans, Albertus Beishuizen, Anne-Fleur van Rootselaar, Jeannette Hofmeijer
The effect on knee-joint load of instruction in analgesic use compared with neuromuscular exercise in patients with knee osteoarthritis: study protocol for a randomized, single-blind, controlled trial (the EXERPHARMA trial)
Brian Clausen, Anders Holsgaard-Larsen, Jens Søndergaard, Robin Christensen, Thomas P Andriacchi, Ewa M Roos
Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial
Bo-Feng Yang, Xiang-Hong Zeng, Yan Liu, Qing-Nan Fu, Tian He, Fang Li, Guang-Xia Shi, Bao-Zhen Liu, San-Feng Sun, Jun Wang, Lei Xiao, Yan-Mei Deng, Cun-Zhi Liu
Right versus left atrial pacing in patients with sick sinus syndrome and paroxysmal atrial fibrillation (Riverleft study): study protocol for randomized controlled trial
Tanwier TTK Ramdjan, Lisette JME van der Does, Paul Knops, Jan CJ Res, Natasja MS de Groot
Publication practices and standards: recommendations from GSK Vaccines’ author survey
Isabelle Camby, Véronique Delpire, Laurence Rouxhet, Thomas Morel, Christine Vanderlinden, Nancy Van Driessche, Tatjana Poplazarova
The transvaginal hybrid NOTES versus conventionally assisted laparoscopic sigmoid resection for diverticular disease (TRANSVERSAL) trial: study protocol for a randomized controlled trial
Jonas D Senft, Rene Warschkow, Markus K Diener, Ignazio Tarantino, Daniel C Steinemann, Sebastian Lamm, Thomas Simon, Andreas Zerz, Beat P Müller-Stich, Georg R Linke
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, Natasha Mitchell, Sarah Nutbrown, Steve Parrott, David Richards, Gemma Traviss, Dominic Trépel, Rebecca Woodhouse, Simon Gilbody
Developing stepped care treatment for depression (STEPS): study protocol for a pilot randomised controlled trial
Jacqueline J Hill, Willem Kuyken, David A Richards
Reducing bias in open-label trials where blinded outcome assessment is not feasible: strategies from two randomised trials
Brennan C Kahan, Suzie Cro, Caroline J Doré, Daniel J Bratton, Sunita Rehal, Nick A Maskell, Najib Rahman, Vipul Jairath
Efficacy of lidocaine in patients receiving palliative care with opioid-refractory cancer pain with a neuropathic component: study protocol for a randomized controlled study
Sébastien Salas, Pascal Auquier, Florence Duffaud, Stéphanie Ranque Garnier, Mélanie Deschamps, Stéphane Honoré, Patrick Sudour, Karine Baumstarck
Effect of guided self-determination youth intervention integrated into outpatient visits versus treatment as usual on glycemic control and life skills: a randomized clinical trial in adolescents with type 1 diabetes
Gitte R Husted, Birger Thorsteinsson, Bente Appel Esbensen, Christian Gluud, Per Winkel, Eva Hommel, Vibeke Zoffmann
Simvastatin to modify neutrophil function in older patients with septic pneumonia (SNOOPI): study protocol for a randomised placebo-controlled trial
Hannah Greenwood, Jaimin Patel, Rahul Mahida, Qian Wang, Dhruv Parekh, Rachel CA Dancer, Heena Khiroya, Elizabeth Sapey, David R Thickett
SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients
Christian Stoppe, Bernard McDonald, Steffen Rex, William Manzanares, Richard Whitlock, Stephen Fremes, Robert Fowler, Yoan Lamarche, Patrick Meybohm, Christoph Haberthür, Rolf Rossaint, Andreas Goetzenich, Gunnar Elke, Andrew Day, Daren K Heyland
Comparison of the efficacy and safety of two starting dosages of prednisolone in early active rheumatoid arthritis (CORRA): study protocol for a randomized controlled trial
Ulrike S Trampisch, Dietmar Krause, Hans J Trampisch, Renate Klaassen-Mielke, Xenofon Baraliakos, Jürgen Braun
Collaborative treatment of late-life depression in primary care (GermanIMPACT): study protocol of a cluster-randomized controlled trial
Iris Wernher, Frederike Bjerregaard, Iris Tinsel, Christiane Bleich, Sigrid Boczor, Thomas Kloppe, Martin Scherer, Martin Härter, Wilhelm Niebling, Hans-Helmut König, Michael Hüll
Evaluation of a community health worker intervention and the World Health Organization’s Option B versus Option A to improve antenatal care and PMTCT outcomes in Dar es Salaam, Tanzania: study protocol for a cluster-randomized controlled health systems implementation trial
David Sando, Pascal Geldsetzer, Lucy Magesa, Irene Andrew Lema, Lameck Machumi, Mary Mwanyika-Sando, Nan Li, Donna Spiegelman, Ester Mungure, Hellen Siril, Phares Mujinja, Helga Naburi, Guerino Chalamilla, Charles Kilewo, Anna Mia Ekström, Wafaie W Fawzi, Till W Bärnighausen
Parenteral nutrition at the palliative phase of advanced cancer: the ALIM-K study protocol for a randomized controlled trial
Lionel Pazart, Elodie Cretin, Ghislain Grodard, Cecile Cornet, Florence Mathieu-Nicot, Franck Bonnetain, Mariette Mercier, Patrice Cuynet, Carole Bouleuc, Regis Aubry
Occupational Therapy in HomEcare Re-ablement Services (OTHERS): study protocol for a randomized controlled trial
Phillip J Whitehead, Avril ER Drummond, Marion F Walker, Ruth H Parry, Ian D McGeorge, Zaid Latif
HALT-IT - tranexamic acid for the treatment of gastrointestinal bleeding: study protocol for a randomised controlled trial
Ian Roberts, Timothy Coats, Phil Edwards, Ian Gilmore, Vipul Jairath, Katharine Ker, Daniela Manno, Haleema Shakur, Simon Stanworth, Andrew Veitch
Post-Exercise Protein Trial: Interactions between Diet and Exercise (PEPTIDE): study protocol for randomized controlled trial
Abdullah F Alghannam, Kostas Tsintzas, Dylan Thompson, James Bilzon, James A Betts
New proposal of silver diamine fluoride use in arresting approximal caries: study protocol for a randomized controlled trial
Juliana Mattos-Silveira, Isabela Floriano, Fernanda R Ferreira, Maria E F Viganó, M A Frizzo, Alessandra Reyes, Tatiane F Novaes, Caroline M Moriyama, Daniela P Raggio, José C P Imparato, Fausto M Mendes, Mariana M Braga
A multicentre phase III randomised controlled single-masked clinical trial evaluating the cl inical e fficacy and safety o f light-masks at p reventing dark-a daptation in the tr eatment of ea rly diabetic macular oedema (CLEOPATRA): study protocol for a randomised controlled trial
Sobha Sivaprasad, Geoffrey Arden, A Toby Prevost, Roxanne Crosby-Nwaobi, Helen Holmes, Joanna Kelly, Caroline Murphy, Gary Rubin, Joanna Vasconcelos, Philip Hykin
Recruitment results among families contacted for an obesity prevention intervention: the Obesity Prevention Tailored for Health Study
Nirupa R Ghai, Kim D Reynolds, Anny H Xiang, Kimberly Massie, Sabrina Rosetti, Lyzette Blanco, Mayra P Martinez, Virginia P Quinn
THE SAAF STUDY: evaluation of the Safeguarding Children Assessment and Analysis Framework (SAAF), compared with management as usual, for improving outcomes for children and young people who have experienced, or are at risk of, maltreatment: study protocol for a randomised controlled trial
Geraldine Macdonald, Jane Lewis, Kenneth Macdonald, Evie Gardner, Lynn Murphy, Catherine Adams, Deborah Ghate, Richard Cotmore, Jonathan Green
Measuring the impact of methodological research: a framework and methods to identify evidence of impact
Valerie C Brueton, Claire L Vale, Babak Choodari-Oskooei, Rachel Jinks, Jayne F Tierney
A randomised trial of treating fibroids with either embolisation or myomectomy to measure the effect on quality of life among women wishing to avoid hysterectomy (the FEMME study): study protocol for a randomised controlled trial
Klim McPherson, Isaac Manyonda, Mary-Ann Lumsden, Anna-Maria Belli, Jon Moss, Olivia Wu, Lee Middleton, Jane Daniels
Ethical and scientific considerations for patient enrollment into concurrent clinical trials
Paul S Myles, Elizabeth Williamson, Justin Oakley, Andrew Forbes
Remifentanil versus fentanyl during cardiac surgery on the incidence of chronic thoracic pain (REFLECT): study protocol for a randomized controlled trial
Sjoerd de Hoogd, Sabine JGM Ahlers, Eric PA van Dongen, Dick Tibboel, Albert Dahan, Catherijne AJ Knibbe
Internet-based cognitive behavioural self-help for premenstrual syndrome: study protocol for a randomised controlled trial
Johanna N Kues, Carolyn Janda, Maria Kleinstäuber, Cornelia Weise
Radioembolisation with yttrium‒90 microspheres versus sorafenib for treatment of advanced hepatocellular carcinoma (SARAH): study protocol for a randomised controlled trial
Valérie Vilgrain, Mohamed Abdel-Rehim, Annie Sibert, Maxime Ronot, Rachida Lebtahi, Laurent Castéra, Gilles Chatellier
Smartphone- and internet-assisted self-management and adherence tools to manage Parkinson’s disease (SMART-PD): study protocol for a randomised controlled trial (v7; 15 August 2014)
Rashmi Lakshminarayana, Duolao Wang, David Burn, K Ray Chaudhuri, Gemma Cummins, Clare Galtrey, Bruce Hellman, Suvankar Pal, Jon Stamford, Malcolm Steiger, Adrian Williams
Comparison of the rhythm control treatment strategy versus the rate control strategy in patients with permanent or long-standing persistent atrial fibrillation and heart failure treated with cardiac resynchronization therapy - a pilot study of Cardiac Resynchronization in Atrial Fibrillation Trial (Pilot-CRAfT): study protocol for a randomized controlled trial
Jan Ciszewski, Aleksander Maciag, Ilona Kowalik, Pawel Syska, Michal Lewandowski, Michal M Farkowski, Anna Borowiec, Tomasz Chwyczko, Mariusz Pytkowski, Hanna Szwed, Maciej Sterlinski
The role of extended-release niacin on immune activation and neurocognition in HIV-infected patients treated with antiretroviral therapy – CTN PT006: study protocol for a randomized controlled trial
Bertrand Lebouché, Mohammad-Ali Jenabian, Joel Singer, Gina M Graziani, Kim Engler, Benoit Trottier, Réjean Thomas, Marie-Josée Brouillette, Jean-Pierre Routy
Effects of aerobic exercise on cognition and hippocampal volume in Alzheimer’s disease: study protocol of a randomized controlled trial (The FIT-AD trial)
Fang Yu, Ulf G Bronas, Suma Konety, Nathaniel W Nelson, Maurice Dysken, Clifford Jack Jr, Jean F Wyman, David Vock, Glenn Smith
Comparison of heparin to citrate as a catheter locking solution for non-tunneled central venous hemodialysis catheters in patients requiring renal replacement therapy for acute renal failure (VERROU-REA study): study protocol for a randomized controlled trial
Rémi Bruyère, Agnès Soudry-Faure, Gilles Capellier, Christine Binquet, Abdelouaid Nadji, Stephane Torner, Gilles Blasco, Maria Yannaraki, Saber Davide Barbar, Jean-Pierre Quenot
Wordless intervention for epilepsy in learning disabilities (WIELD): study protocol for a randomized controlled feasibility trial
Marie-Anne Durand, Bob Gates, Georgina Parkes, Asif Zia, Karin Friedli, Garry Barton, Howard Ring, Linda Oostendorp, David Wellsted
Task sharing of a psychological intervention for maternal depression in Khayelitsha, South Africa: study protocol for a randomized controlled trial
Crick Lund, Marguerite Schneider, Thandi Davies, Memory Nyatsanza, Simone Honikman, Arvin Bhana, Judith Bass, Paul Bolton, Michael Dewey, John Joska, Ashraf Kagee, Landon Myer, Inge Petersen, Martin Prince, Dan J Stein, Graham Thornicroft, Mark Tomlinson, Atalay Alem, Ezra Susser
Acupuncture for adolescents with mild-to-moderate myopia: study protocol for a randomized controlled trial
Yan Wang, Yun-xian Gao, Qi Sun, Qian Bu, Jing Shi, Ya-ni Zhang, Qin Xu, Yan Ji, Min Tong, Guang-li Jiang
Implementing an early childhood school-based mental health promotion intervention in low-resource Ugandan schools: study protocol for a cluster randomized controlled trial
Keng-Yen Huang, Janet Nakigudde, Esther Calzada, Michael J Boivin, Gbenga Ogedegbe, Laurie Miller Brotman
Expanding Paramedicine in the Community (EPIC): study protocol for a randomized controlled trial
Ian R Drennan, Katie N Dainty, Paul Hoogeveen, Clare L Atzema, Norm Barrette, Gillian Hawker, Jeffrey S Hoch, Wanrudee Isaranuwatchai, Jane Philpott, Chris Spearen, Walter Tavares, Linda Turner, Melissa Farrell, Tom Filosa, Jennifer Kane, Alex Kiss, Laurie J Morrison
Pre-Operative nutrition In Neck of femur Trial (POINT) - carbohydrate loading in patients with fragility hip fracture: study protocol for a randomised controlled trial
Iain K Moppett, Paul L Greenhaff, Ben J Ollivere, Theophillus Joachim, Dileep N Lobo, Martin Rowlands
Transversus abdominis plane block versus perioperative intravenous lidocaine versus patient-controlled intravenous morphine for postoperative pain control after laparoscopic colorectal surgery: study protocol for a prospective, randomized, double-blind controlled clinical trial
Geertrui Dewinter, Marc Van de Velde, Steffen Fieuws, Andre D’Hoore, Steffen Rex
Efficacy and safety of Shenyankangfu tablets for primary glomerulonephritis: study protocol for a randomized controlled trial
Jia Kou, Jie Wu, Hong-tao Yang, Ya-ni He, Jing-ai Fang, Yue-yi Deng, Yuan-sheng Xie, Li-fang Nie, Hong-li Lin, Guang-yan Cai, Xiang-mei Chen
Guided (VENTRI-GUIDE) versus freehand ventriculostomy: study protocol for a randomized controlled trial
Asita Sarrafzadeh, Nicolas Smoll, Karl Schaller
Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial
Joni S Williams, Cheryl P Lynch, Rebecca G Knapp, Leonard E Egede
The effect of changing stool collection processes on compliance in nationwide organized screening using a fecal occult blood test (FOBT) in Korea: study protocol for a randomized controlled trial
Hye Young Shin, Mina Suh, Hyung Won Baik, Kui Son Choi, Boyoung Park, Jae Kwan Jun, Chan Wha Lee, Jae Hwan Oh, You Kyoung Lee, Dong Soo Han, Do-Hoon Lee
Evaluation of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: study protocol for a randomised controlled trial
William Jeffcoate, Frances Game, Patricia Price, Ceri Phillips, Vivienne Turtle-Savage
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
Building clinical trial priorities at the University of Rwanda
Jeanine Condo, Brenda Kateera, Eugene Mutimura, Francine Birungi, Albert Ndagijimana, Stefan Jansen, Julius Kamwesiga, Jamie I Forrest, Edward J Mills, Agnes Binagwaho
Afatinib versus placebo as adjuvant therapy after chemoradiation in a double-blind, phase III study (LUX-Head & Neck 2) in patients with primary unresected, clinically intermediate-to-high-risk head and neck cancer: study protocol for a randomized controlled trial
Barbara Burtness, Jean P Bourhis, Jan B Vermorken, Kevin J Harrington, Ezra EW Cohen
Comparison of posterior foraminotomy and anterior foraminotomy with fusion for treating spondylotic foraminal stenosis of the cervical spine: study protocol for a randomized controlled trial (ForaC)
Anja Tschugg, Sabrina Neururer, Kai Michael Scheufler, Hanno Ulmer, Claudius Thomé, Aldemar Andres Hegewald
The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial
Margaret Thorogood, Jane Goudge, Melanie Bertram, Tobias Chirwa, Sandra Eldridge, Francesc Xavier Gómez-Olivé, Felix Limbani, Eustasius Musenge, Nokuzola Myakayaka, Stephen Tollman, Rhian Twine
A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial
Angus J M Watson, Hanne Bruhn, Kathleen MacLeod, Alison McDonald, Gladys McPherson, Mary Kilonzo, John Norrie, Malcolm A Loudon, Kirsty McCormack, Brian Buckley, Steven Brown, Finlay Curran, David Jayne, Ramesh Rajagopal, Jonathan A Cook
CryptoDex: A randomised, double-blind, placebo-controlled phase III trial of adjunctive dexamethasone in HIV-infected adults with cryptococcal meningitis: study protocol for a randomised control trial
Jeremy Day, Darma Imran, Ahmed Rizal Ganiem, Natriana Tjahjani, Retno Wahyuningsih, Robiatul Adawiyah, David Dance, Mayfong Mayxay, Paul Newton, Rattanaphone Phetsouvanh, Sayaphet Rattanavong, Adrienne K Chan, Robert Heyderman, Joep J van Oosterhout, Wirongrong Chierakul, Nick Day, Anatoli Kamali, Freddie Kibengo, Eugene Ruzagira, Alastair Gray, David G Lalloo, Justin Beardsley, Tran Quang Binh, Tran Thi Hong Chau, Nguyen Van Vinh Chau, Ngo Thi Kim Cuc, Jeremy Farrar, Tran Tinh Hien, Nguyen Van Kinh, Laura Merson, Lan Phuong, Loc Truong Tho, Pham Thanh Thuy, Guy Thwaites, Heiman Wertheim, Marcel Wolbers
Effect of a structured psycho-oncological screening and treatment model on mental health in cancer patients (STEPPED CARE): study protocol for a cluster randomized controlled trial
Susanne Singer, Helge Danker, Susanne Briest, Arne Dietrich, Andreas Dietz, Jens Einenkel, Kirsten Papsdorf, Florian Lordick, Jürgen Meixensberger, Joachim Mössner, Dietger Niederwieser, Torsten Prietzel, Franziska Schiefke, Jens-Uwe Stolzenburg, Hubert Wirtz, Anette Kersting
Comparison of anticipated and actual control group outcomes in randomised trials in paediatric oncology provides evidence that historically controlled studies are biased in favour of the novel treatment
Veronica Moroz, Jayne S Wilson, Pamela Kearns, Keith Wheatley
Supporting physical activity engagement in people with Huntington’s disease (ENGAGE-HD): study protocol for a randomized controlled feasibility trial
Monica Busse, Lori Quinn, Helen Dawes, Carys Jones, Mark Kelson, Vincent Poile, Rob Trubey, Julia Townson, Rhiannon Tudor Edwards, Anne Rosser, Kerenza Hood
In search of justification for the unpredictability paradox
Jeremy Howick, Alexander Mebius
Ultrafiltration biofeedback guided by blood volume monitoring to reduce intradialytic hypotensive episodes in hemodialysis: study protocol for a randomized controlled trial
Kelvin CW Leung, Robert R Quinn, Pietro Ravani, Jennifer M MacRae
Applying Tai Chi as a rehabilitation program for stroke patients in the recovery phase: study protocol for a randomized controlled trial
Yong Zhang, Hongwei Liu, Li Zhou, Kai Chen, He Jin, Yihuai Zou, Zongheng Li
Process evaluation of the implementation of dementia-specific case conferences in nursing homes (FallDem): study protocol for a randomized controlled trial
Daniela Holle, Martina Roes, Ines Buscher, Sven Reuther, René Müller, Margareta Halek
The Calcineurin Inhibitor-Sparing (CIS) Trial - individualised calcineurin-inhibitor treatment by immunomonitoring in renal allograft recipients: protocol for a randomised controlled trial
Claudia Sommerer, Matthias Schaier, Christian Morath, Vedat Schwenger, Geraldine Rauch, Thomas Giese, Martin Zeier
Effectiveness of app-based relaxation for patients with chronic low back pain (Relaxback) and chronic neck pain (Relaxneck): study protocol for two randomized pragmatic trials
Susanne Blödt, Daniel Pach, Stephanie Roll, Claudia M Witt
Effects of phototherapy on muscle activity and pain in individuals with temporomandibular disorder: a study protocol for a randomized controlled trial
Carolina Marciela Herpich, Ernesto Cesar Pinto Leal-Junior, Ana Paula Amaral, Juliana de Paiva Tosato, Igor Phillip dos Santos Glória, Marília Barbosa Santos Garcia, Bruno Roberto Borges Barbosa, Yasmin El Hage, Éric Edmur Camargo Arruda, Cid Ándre Fidelis de Paula Gomes, Monique Sampaio Rodrigues, Dowglas Fernando Magalhães de Sousa, Paulo de Tarso Camillo de Carvalho, Sandra Kalil Bussadori, Tabajara de Oliveira Gonzalez, Fabiano Politti, Daniela Aparecida Biasotto-Gonzalez
Weekly low-dose methotrexate for reduction of Global Initiative for Asthma Step 5 treatment in severe refractory asthma: study protocol for a randomized controlled trial
Riccardo Polosa, Salvatore Bellinvia, Massimo Caruso, Rosalia Emma, Angela Alamo, Marek Leszek Kowalski, Christian Domingo
International Clinical Trial Day and clinical trials in Ethiopia and Africa
Abebaw Fekadu, Solomon Teferra, Asrat Hailu, Tsige Gebre-Mariam, Adamu Addissie, Wakgari Deressa, Getnet Yimer, Ahmed Reja
Oral granulated Chinese herbal medicine (YXBCM01) plus topical calcipotriol for psoriasis vulgaris: study protocol for a double-blind, randomized placebo controlled trial
Shefton Parker, Anthony Lin Zhang, Claire Shuiqing Zhang, Greg Goodman, Zehuai Wen, Chuanjian Lu, Charlie Changlie Xue
Assessing the implementation effectiveness and safety of 1% tenofovir gel provision through family planning services in KwaZulu-Natal, South Africa: study protocol for an open-label randomized controlled trial
Leila E Mansoor, Quarraisha Abdool Karim, Kathryn T Mngadi, Sarah Dlamini, Carl Montague, Nelisiwe Nkomonde, Nomzamo Mvandaba, Cheryl Baxter, Tanuja N Gengiah, Natasha Samsunder, Halima Dawood, Anneke Grobler, Janet A Frohlich, Salim S Abdool Karim
Polidocanol versus hypertonic glucose for sclerotherapy treatment of reticular veins of the lower limbs: study protocol for a randomized controlled trial
Matheus Bertanha, Marcone Lima Sobreira, Carlos Eduardo Pinheiro Lúcio Filho, Jamil Victor de Oliveira Mariúba, Rafael Elias Farres Pimenta, Rodrigo Gibin Jaldin, Andrei Moroz, Regina Moura, Hamilton Almeida Rollo, Winston Bonetti Yoshida
Empowering pharmacists in asthma management through interactive SMS (EmPhAsIS): study protocol for a randomized controlled trial
Mary A De Vera, Mohsen Sadatsafavi, Nicole W Tsao, Larry D Lynd, Richard Lester, Louise Gastonguay, Jessica Galo, J Mark FitzGerald, Penelope Brasher, Carlo A Marra
Constraint-induced movement therapy: trial sequential analysis applied to Cochrane collaboration systematic review results
Greta Castellini, Silvia Gianola, Rita Banzi, Davide Corbetta, Roberto Gatti, Valeria Sirtori, Christian Gluud, Lorenzo Moja
Characteristics associated with willingness to participate in a randomized controlled behavioral clinical trial using home-based personal computers and a webcam
Hiroko H Dodge, Yuriko Katsumata, Jian Zhu, Nora Mattek, Molly Bowman, Mattie Gregor, Katherine Wild, Jeffrey A Kaye
Improved self-management skills in Chinese diabetes patients through a comprehensive health literacy strategy: study protocol of a cluster randomized controlled trial
Wang Hong Xu, Russell L Rothman, Rui Li, Yingyao Chen, Qinghua Xia, Hong Fang, Junling Gao, Yujie Yan, Peng Zhou, Yu Jiang, Yinan Liu, Fangjia Zhou, Wei Wang, Minling Chen, Xiao Yu Liu, Xiao Na Liu
Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial): study protocol for a randomised controlled trial
Palle Toft, Hanne Tanghus Olsen, Helene Korvenius Jørgensen, Thomas Strøm, Helle Lykkeskov Nibro, Jacob Oxlund, Karl-Andre Wian, Lars Marius Ytrebø, Bjørn Anders Kroken, Michelle Chew
A Bayesian prediction model between a biomarker and the clinical endpoint for dichotomous variables
Zhiwei Jiang, Yang Song, Qiong Shou, Jielai Xia, William Wang
A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set
Alessandro Chiarotto, Caroline B Terwee, Richard A Deyo, Maarten Boers, Chung-Wei Christine Lin, Rachelle Buchbinder, Terry P Corbin, Leonardo OP Costa, Nadine E Foster, Margreth Grotle, Bart W Koes, Francisco M Kovacs, Chris G Maher, Adam M Pearson, Wilco C Peul, Mark L Schoene, Dennis C Turk, Maurits W van Tulder, Raymond W Ostelo
An experienced physiotherapist prescribing and administering corticosteroid and local anaesthetic injections to the shoulder in an Australian orthopaedic service, a non-inferiority randomised controlled trial and economic analysis: study protocol for a randomised controlled trial
Darryn Marks, Leanne Bisset, Michael Thomas, Shaun O’Leary, Tracy Comans, Shu Kay Ng, Philip G Conaghan, Paul Scuffham
Identifying continence options after stroke (ICONS): a cluster randomised controlled feasibility trial
Lois H Thomas, Caroline L Watkins, Christopher J Sutton, Denise Forshaw, Michael J Leathley, Beverley French, Christopher R Burton, Francine Cheater, Brenda Roe, David Britt, Joanne Booth, Elaine McColl
A comparison of cognitive-behavioral couple therapy and lidocaine in the treatment of provoked vestibulodynia: study protocol for a randomized clinical trial
Serena Corsini-Munt, Sophie Bergeron, Natalie O Rosen, Marc Steben, Marie-Hélène Mayrand, Isabelle Delisle, Pierre McDuff, Leen Aerts, Marie Santerre-Baillargeon
Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2)
Laurent Brisard, Amélie Le Gouge, Jean-Baptiste Lascarrou, Hervé Dupont, Pierre Asfar, Michel Sirodot, Gael Piton, Hoang-Nam Bui, Olivier Gontier, Ali Ait Hssain, Stéphane Gaudry, Jean-Philippe Rigaud, Jean-Pierre Quenot, Virginie Maxime, Carole Schwebel, Didier Thévenin, Saad Nseir, Erika Parmentier, Ahmed El Kalioubie, Mercé Jourdain, Véronique Leray, Nathalie Rolin, Frédéric Bellec, Vincent Das, Frédérique Ganster, Christophe Guitton, Karim Asehnoune, Anne Bretagnol, Nadia Anguel, Jean-Paul Mira, Emmanuel Canet, Bertrand Guidet, Michel Djibre, Benoit Misset, René Robert, Frédéric Martino, Philippe Letocart, Daniel Silva, Michael Darmon, Vlad Botoc, Jean Etienne Herbrecht, Ferhat Meziani, Jérôme Devaquet, Emmanuelle Mercier, Jack Richecoeur, Stéphanie Martin, Emilie Gréau, Bruno Giraudeau, Jean Reignier
Out & Online; effectiveness of a tailored online multi-symptom mental health and wellbeing program for same-sex attracted young adults: study protocol for a randomised controlled trial
Jo-Anne M Abbott, Britt Klein, Suzanne McLaren, David W Austin, Mari Molloy, Denny Meyer, Bronte McLeod
Detailed statistical analysis plan for the pulmonary protection trial
Katrine B Buggeskov, Janus C Jakobsen, Niels H Secher, Thomas Jonassen, Lars W Andersen, Daniel A Steinbrüchel, Jørn Wetterslev
Short-term influence of cataract surgery on circadian biological rhythm and related health outcomes (CLOCK-IOL trial): study protocol for a randomized controlled trial
Keigo Saeki, Kenji Obayashi, Tomo Nishi, Kimie Miyata, Shinji Maruoka, Tetsuo Ueda, Masahiro Okamoto, Taiji Hasegawa, Toyoaki Matsuura, Nobuhiro Tone, Nahoko Ogata, Norio Kurumatani
A mobile phone intervention to reduce binge drinking among disadvantaged men: study protocol for a randomised controlled cost-effectiveness trial
Iain K Crombie, Linda Irvine, Brian Williams, Falko F Sniehotta, Dennis Petrie, Josie MM Evans, Carol Emslie, Claire Jones, Ian W Ricketts, Gerry Humphris, John Norrie, Peter Rice, Peter W Slane
The TRANSNephro-study examining a new transition model for post-kidney transplant adolescents and an analysis of the present health care: study protocol for a randomized controlled trial
Martin Kreuzer, Jenny Prüfe, Dirk Bethe, Charlotte Vogel, Anika Großhennig, Armin Koch, Martina Oldhafer, Marie-Luise Dierks, Urs-Vito Albrecht, Silvia Müther, Reinhard Brunkhorst, Lars Pape
Comparison of everolimus-eluting and biolimus-eluting coronary stents with everolimus-eluting bioresorbable scaffold: study protocol of the randomized controlled EVERBIO II trial
Diego Arroyo, Mario Togni, Serban Puricel, Baeriswyl Gerard, Lehmann Sonja, Noé Corpataux, Hélène Villeneuve, Estelle Boute, Jean-Christophe Stauffer, Jean-Jacques Goy, Stéphane Cook
Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study
Marquis S Hawkins, Linda J Hough, Marie A Berger, Maria K Mor, Ann R Steenkiste, Shasha Gao, Roslyn A Stone, Kelly H Burkitt, Bess H Marcus, Joseph T Ciccolo, Andrea M Kriska, Deborah T Klinvex, Mary A Sevick
A rehabilitation intervention to promote physical recovery following intensive care: a detailed description of construct development, rationale and content together with proposed taxonomy to capture processes in a randomised controlled trial
Pam Ramsay, Lisa G Salisbury, Judith L Merriweather, Guro Huby, Janice E Rattray, Alastair M Hull, Stephen J Brett, Simon J Mackenzie, Gordon D Murray, John F Forbes, Timothy Simon Walsh
Study protocol for a randomized, controlled, superiority trial comparing the clinical and cost- effectiveness of integrated online mental health assessment-referral-care in pregnancy to usual prenatal care on prenatal and postnatal mental health and infant health and development: the Integrated Maternal Psychosocial Assessment to Care Trial (IMPACT)
Dawn Kingston, Marie-Paule Austin, Kathy Hegadoren, Sheila McDonald, Gerri Lasiuk, Sarah McDonald, Maureen Heaman, Anne Biringer, Wendy Sword, Rebecca Giallo, Tejal Patel, Marie Lane-Smith, Sander Veldhuyzen van Zanten
The prevention of anxiety in children through school-based interventions: study protocol for a 24-month follow-up of the PACES project
Paul Stallard, Gordon Taylor, Rob Anderson, Harry Daniels, Neil Simpson, Rhiannon Phillips, Elena Skryabina
Implementation of observational pain management protocol to improve pain management for long-term institutionalized older care residents with dementia: study protocol for a cluster-randomized controlled trial
Justina Yat Wa Liu, Claudia Lai
First metatarsophalangeal joint arthrodesis versus proximal phalanx hemiarthroplasty for hallux rigidus: feasibility study for a randomised controlled trial
Hiren Maganlal Divecha, Aamir I Zubairy, James L Barrie, Shivashanker Aithal, Benjamin Fischer, Thomas Fanshawe, Asim Rajpura
Can virtual nature improve patient experiences and memories of dental treatment? A study protocol for a randomized controlled trial
Karin Tanja-Dijkstra, Sabine Pahl, Mathew P White, Jackie Andrade, Jon May, Robert J Stone, Malcolm Bruce, Ian Mills, Melissa Auvray, Rhys Gabe, David R Moles
The effectiveness of Tai Chi on the physical and psychological well-being of college students: a study protocol for a randomized controlled trial
Guohua Zheng, Xiulu Lan, Moyi Li, Kun Ling, Hui Lin, Lidian Chen, Jing Tao, Junzhe Li, Xin Zheng, Bai Chen, Qianying Fang
Endoscopic versus open radial artery harvest and mammario-radial versus aorto-radial grafting in patients undergoing coronary artery bypass surgery: protocol for the 2 × 2 factorial designed randomised NEO trial
Christian L Carranza, Martin Ballegaard, Mads U Werner, Philip Hasbak, Andreas Kjær, Klaus F Kofoed, Jane Lindschou, Janus Christian Jakobsen, Christian Gluud, Peter Skov Olsen, Daniel A Steinbrüchel
Low-level night-time light therapy for age-related macular degeneration (ALight): study protocol for a randomized controlled trial
Claire McKeague, Tom H Margrain, Clare Bailey, Alison M Binns
Improving access to preparatory information for children undergoing general anaesthesia for tooth extraction and their families: study protocol for a Phase III randomized controlled trial
Marie Therese Hosey, Ana Nora Donaldson, Corinne Huntington, Christina Liossi, Patricia A Reynolds, Reham Alharatani, J Timothy Newton
Effectiveness of phototherapy incorporated into an exercise program for osteoarthritis of the knee: study protocol for a randomized controlled trial
Carly de Faria Coelho, Ernesto Cesar Pinto Leal-Junior, Daniela Aparecida Biasotto-Gonzalez, André Serra Bley, Paulo de Tarso de Camillo de Carvalho, Fabiano Politti, Tabajara de Oliveira Gonzalez, Adriano Rodrigues de Oliveira, Marcelo Frigero, Marilia Barbosa Santos Garcia, Almir Vieira Dibai-Filho, Cid André Fidelis de Paula Gomes
Cord pilot trial - immediate versus deferred cord clamping for very preterm birth (before 32 weeks gestation): study protocol for a randomized controlled trial
Angela Pushpa-Rajah, Lucy Bradshaw, Jon Dorling, Gill Gyte, Eleanor J Mitchell, Jim Thornton, Lelia Duley
A double-blind, placebo-controlled intervention trial of 3 and 10 mg sublingual melatonin for post-concussion syndrome in youths (PLAYGAME): study protocol for a randomized controlled trial
Karen M Barlow, Brian L Brooks, Frank P MacMaster, Adam Kirton, Trevor Seeger, Michael Esser, Susan Crawford, Alberto Nettel-Aguirre, Roger Zemek, Mikrogianakis Angelo, Valerie Kirk, Carolyn A Emery, David Johnson, Michael D Hill, Jeff Buchhalter, Brenda Turley, Lawrence Richer, Robert Platt, Jamie Hutchison, Deborah Dewey
A systematic review of factors affecting children’s right to health in cluster randomized trials in Kenya
Elizabeth Oduwo, Sarah JL Edwards
Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials
Beena G Sood, Martin Keszler, Meena Garg, Jonathan M Klein, Robin Ohls, Namasivayam Ambalavanan, C Michael Cotten, Monica Malian, Pablo J Sanchez, Satyan Lakshminrusimha, Leif D Nelin, Krisa P Van Meurs, Rebecca Bara, Shampa Saha, Abhik Das, Dennis Wallace, Rosemary D Higgins, Seetha Shankaran
Statistical analysis plan for the Erythropoietin in Traumatic Brain Injury trial: a randomised controlled trial of erythropoietin versus placebo in moderate and severe traumatic brain injury
Jeffrey Presneill, Lorraine Little, Alistair Nichol, Craig French, D James Cooper, Samir Haddad, Jacques Duranteau, Olivier Huet, Markus Skrifvars, Yaseen Arabi, Rinaldo Bellomo
Economic evaluation of the prophylaxis for thromboembolism in critical care trial (E-PROTECT): study protocol for a randomized controlled trial
Robert A Fowler, Nicole Mittmann, William H Geerts, Diane Heels-Ansdell, Michael K Gould, Gordon Guyatt, Murray Krahn, Simon Finfer, Ruxandra Pinto, Brian Chan, Orges Ormanidhi, Yaseen Arabi, Ismael Qushmaq, Marcelo G Rocha, Peter Dodek, Lauralyn McIntyre, Richard Hall, Niall D Ferguson, Sangeeta Mehta, John C Marshall, Christopher James Doig, John Muscedere, Michael J Jacka, James R Klinger, Nicholas Vlahakis, Neil Orford, Ian Seppelt, Yoanna K Skrobik, Sachin Sud, John F Cade, Jamie Cooper, Deborah Cook
A web-based support for pregnant women and new mothers with type 1 diabetes mellitus in Sweden (MODIAB-Web): study protocol for a randomized controlled trial
Annsofie Adolfsson, Karolina Linden, Carina Sparud-Lundin, Per-Göran Larsson, Marie Berg
Erratum to: comparing single-site with multisite rTMS for the treatment of chronic tinnitus - clinical effects and neuroscientific insights: study protocol for a randomized controlled trial
Astrid Lehner, Martin Schecklmann, Peter M Kreuzer, Timm B Poeppl, Rainer Rupprecht, Berthold Langguth
Erratum to: Prednisolone and acupuncture in Bell’s palsy: study protocol for a randomized, controlled trial
Feng Xia, Junliang Han, Xuedong Liu, Jingcun Wang, Zhao Jiang, Kangjun Wang, Songdi Wu, Gang Zhao