Trials

A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: Design and statistical methods of the PERSEUS clinical program

Dominic J Allocco, Louis A Cannon, Amy Britt, John E Heil, Andrey Nersesov, Scott Wehrenberg, Keith D Dawkins, Dean J Kereiakes

Questionnaires in clinical trials: guidelines for optimal design and administration

Phil Edwards

Losartan therapy in adults with Marfan syndrome: study protocol of the multi-center randomized controlled COMPARE trial

Teodora Radonic, Piet de Witte, Marieke JH Baars, Aeilko H Zwinderman, Barbara JM Mulder, Maarten Groenink

Alberta Diabetes and Physical Activity Trial (ADAPT): A randomized theory-based efficacy trial for adults with type 2 diabetes - rationale, design, recruitment, evaluation, and dissemination

Ronald C Plotnikoff, Kerry S Courneya, Ronald J Sigal, Jeffrey A Johnson, Nicholas Birkett, David Lau, Kim Raine, Steven T Johnson, Nandini Karunamuni

Improving the management of non-ST elevation acute coronary syndromes: systematic evaluation of a quality improvement programme E uropean QU ality I mprovement P rogramme for A cute C oronary S yndrome: The EQUIP-ACS project protocol and design

Marcus D Flather, Jean Booth, Daphne Babalis, Hector Bueno, Philippe G Steg, Grzegorz Opolski, Filippo Ottani, Jacques Machecourt, Alfredo Bardaji, Mats Bojestig, Anthony R Brady, Bertil Lindahl

Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial

Steve Iliffe, Denise Kendrick, Richard Morris, Dawn Skelton, Heather Gage, Susie Dinan, Zoe Stevens, Mirilee Pearl, Tahir Masud

Hand sanitisers for reducing illness absences in primary school children in New Zealand: a cluster randomised controlled trial study protocol

Joanne E McKenzie, Patricia Priest, Rick Audas, Marion R Poore, Cheryl R Brunton, Lesley M Reeves

The B-VITAGE trial: A randomized trial of homocysteine lowering treatment of depression in later life

Andrew H Ford, Leon Flicker, Kieran McCaul, Frank van Bockxmeer, Sarah Hegarty, Varsha Hirani, Stephen Fenner, Osvaldo P Almeida

Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers

Iain Hrynaszkiewicz, Melissa L Norton, Andrew J Vickers, Douglas G Altman

The STRIPES Trial - Support to Rural India's Public Education System

Alex Eble, Vera Mann, Preetha Bhakta, Rashmi Lakshminarayana, Chris Frost, Diana Elbourne, Peter Boone

Feasibility study to inform the design of a randomised controlled trial to eradicate Pseudomonas aeruginosa infection in individuals with Cystic Fibrosis

Helen R Hickey, Ashley P Jones, Warren Lenney, Paula R Williamson, Rosalind L Smyth

The EVERT (effective verruca treatments) trial protocol: a randomised controlled trial to evaluate cryotherapy versus salicylic acid for the treatment of verrucae

E Sarah Cockayne

Evidence-based interventions in dementia: A pragmatic cluster-randomised trial of an educational intervention to promote earlier recognition and response to dementia in primary care (EVIDEM-ED)

Steve Iliffe, Jane Wilcock, Mark Griffin, Priya Jain, Ingela Thuné-Boyle, Tamar Koch, Frances Lefford

Effects of a mouthwash with chlorine dioxide on oral malodor and salivary bacteria: a randomized placebo-controlled 7-day trial

Kayoko Shinada, Masayuki Ueno, Chisato Konishi, Sachiko Takehara, Sayaka Yokoyama, Takashi Zaitsu, Mari Ohnuki, Fredrick Allan Clive Wright, Yoko Kawaguchi

The randomized shortened dental arch study (RaSDA): design and protocol

Ralph G Luthardt, Birgit Marré, Achim Heinecke, Joachim Gerss, Hans Aggstaller, Eckhard Busche, Paul Dressler, Ingrid Gitt, Wolfgang Hannak, Sinsa Hartmann, Guido Heydecke, Florentine Jahn, Matthias Kern, Torsten Mundt, Peter Pospiech, Helmut Stark, Bernd Wöstmann, Michael H Walter

Rationale and design of the ADDITION-Leicester study, a systematic screening programme and Randomised Controlled Trial of multi-factorial cardiovascular risk intervention in people with Type 2 Diabetes Mellitus detected by screening

DR Webb, K Khunti, B Srinivasan, LJ Gray, N Taub, S Campbell, J Barnett, J Henson, S Hiles, A Farooqi, SJ Griffin, NJ Wareham, MJ Davies

A systematic review of techniques and interventions for improving adherence to inclusion and exclusion criteria during enrolment into randomised controlled trials

Fiona Simpson, Elizabeth A Sweetman, Gordon S Doig

The effectiveness of joint crisis plans for people with borderline personality disorder: protocol for an exploratory randomised controlled trial

Paul Moran, Rohan Borschmann, Clare Flach, Barbara Barrett, Sarah Byford, Joanna Hogg, Morven Leese, Kim Sutherby, Claire Henderson, Diana Rose, Mike Slade, George Szmukler, Graham Thornicroft

Prevention of depression and sleep disturbances in elderly with memory-problems by activation of the biological clock with light - a randomized clinical trial

Els IS Most, Philip Scheltens, Eus JW Van Someren

Applicability and generalisability of the results of systematic reviews to public health practice and policy: a systematic review

Nizar Ahmad, Isabelle Boutron, Agnès Dechartres, Pierre Durieux, Philippe Ravaud

Rationale and design of the randomised clinical trial comparing early medication change (EMC) strategy with treatment as usual (TAU) in patients with Major Depressive Disorder - the EMC trial

André Tadić, Stanislav Gorbulev, Norbert Dahmen, Christoph Hiemke, Dieter F Braus, Joachim Röschke, Dietrich van Calker, Daniel Wachtlin, Kai Kronfeld, Thorsten Gorbauch, Monika Seibert-Grafe, Klaus Lieb

Studying a disease with no home - lessons in trial recruitment from the PATCH II study

Kim S Thomas

Erratum to: Protocol for the PINCER trial: a cluster randomised trial comparing the effectiveness of a pharmacist-led IT-based intervention with simple feedback in reducing rates of clinically important errors in medicines management in general practices

Anthony J Avery, Sarah Rodgers, Judith A Cantrill, Sarah Armstrong, Rachel Elliott, Rachel Howard, Denise Kendrick, Caroline J Morris, Scott A Murray, Robin J Prescott, Kathrin Cresswell, Aziz Sheikh

Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach

Kristine K Westrom, Michele J Maiers, Roni L Evans, Gert Bronfort

The effectiveness of a web-based self-help intervention to reduce suicidal thoughts: A randomized controlled trial

Bregje A J van Spijker, Annemieke van Straten, Ad J F M Kerkhof

Protocol for a pilot randomised controlled clinical trial to compare the effectiveness of a graduated three layer straight tubular bandaging system when compared to a standard short stretch compression bandaging system in the management of people with venous ulceration: 3VSS2008

Carolina D Weller, Sue Evans, Christopher M Reid, Rory Wolfe, John McNeil

JinQi-Jiangtang tablet, a Chinese patent medicine, for pre-diabetes: a randomized controlled trial

Hongbo Cao, Ming Ren, Liping Guo, Hongcai Shang, Junhua Zhang, Yuzhen Song, Hui Wang, Baohe Wang, Xiantao Li, Jing Hu, Xuemei Wang, Dehui Wang, Jianzong Chen, Shuanglei Li, Liming Chen

Obstacles to researching the researchers: A case study of the ethical challenges of undertaking methodological research investigating the reporting of randomised controlled trials

Joanne E McKenzie, G Peter Herbison, Paul Roth, Charlotte Paul

Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

Patrick Jahn, Maria Kitzmantel, Petra Renz, Ene Kukk, Oliver Kuss, Anette Thoke-Colberg, Ingrid Horn, Margarete Landenberger

A single blind randomized controlled trial of cognitive behavioural therapy in a help-seeking population with an At Risk Mental State for psychosis: the Dutch Early Detection and Intervention Evaluation (EDIE-NL) trial

Judith Rietdijk, Sara Dragt, Rianne Klaassen, Helga Ising, Dorien Nieman, Lex Wunderink, Philippe Delespaul, Pim Cuijpers, Don Linszen, Mark van der Gaag

Reasons for participating in randomised controlled trials: conditional altruism and considerations for self

Sharon K McCann, Marion K Campbell, Vikki A Entwistle

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials

Kenneth F Schulz, Douglas G Altman, David Moher

Cars, CONSORT 2010, and Clinical Practice

Hywel C Williams

Bojungikgitang and banhabaekchulchonmatang in adult patients with tinnitus, a randomized, double-blind, three-arm, placebo-controlled trial - study protocol

Nam-Kwen Kim, Dong-Hyo Lee, Jung-Hun Lee, Yong-Leol Oh, In-Hwan Yoon, Eun-Sung Seo, Chung-Ho Lee

Rationale and design: telephone-delivered behavioral skills interventions for African Americans with type 2 diabetes

Leonard E Egede, Joni L Strom, Valerie L Durkalski, Patrick D Mauldin, William P Moran

Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial

Karen J Sherman, Daniel C Cherkin, Andrea J Cook, Rene J Hawkes, Richard A Deyo, Robert Wellman, Partap S Khalsa

Reporting bias in medical research - a narrative review

Natalie McGauran, Beate Wieseler, Julia Kreis, Yvonne-Beatrice Schüler, Heike Kölsch, Thomas Kaiser

Does a colour-coded blood pressure diary improve blood pressure control for patients in general practice: The CoCo trial

Claudia Steurer-Stey, Marco Zoller, Corinne Chmiel Moshinsky, Oliver Senn, Thomas Rosemann

The Health Informatics Trial Enhancement Project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial

Joanna McGregor, Caroline Brooks, Padmaja Chalasani, Jude Chukwuma, Hayley Hutchings, Ronan A Lyons, Keith Lloyd

The WOMAN Trial (World Maternal Antifibrinolytic Trial): tranexamic acid for the treatment of postpartum haemorrhage: an international randomised, double blind placebo controlled trial

Haleema Shakur, Diana Elbourne, Metin Gülmezoglu, Zarko Alfirevic, Carine Ronsmans, Elizabeth Allen, Ian Roberts

A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol

Brian H Cuthbertson, Marion K Campbell, Stephen A Stott, Luke Vale, John Norrie, John Kinsella, Jonathan Cook, Julie Brittenden, Adrian Grant

The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma

Mara Ozolins, Hywel C Williams, Sarah J Armstrong, Fiona J Bath-Hextall

A systematic review of clinical trials of pharmacological interventions for acute ischaemic stroke (1955-2008) that were completed, but not published in full

Lorna M Gibson, Miriam Brazzelli, Brenda M Thomas, Peter AG Sandercock

Evaluation of a toolkit to improve cardiovascular disease screening and treatment for people with type 2 diabetes: protocol for a cluster-randomized pragmatic trial

Baiju R Shah, Onil Bhattacharyya, Catherine Yu, Muhammad Mamdani, Janet A Parsons, Sharon E Straus, Merrick Zwarenstein

Comparative effectiveness research: Challenges for medical journals

Harold C Sox, Mark Helfand, Jeremy Grimshaw, Kay Dickersin, David Tovey, J André Knottnerus, Peter Tugwell

Maintenance Cognitive Stimulation Therapy (CST) for dementia: A single-blind, multi-centre, randomized controlled trial of Maintenance CST vs. CST for dementia

Elisa Aguirre, Aimee Spector, Juanita Hoe, Ian T Russell, Martin Knapp, Robert T Woods, Martin Orrell

ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial

Markus K Diener, Thomas Bruckner, Pietro Contin, Christopher Halloran, Matthias Glanemann, Hans Jürgen Schlitt, Joachim Mössner, Meinhard Kieser, Jens Werner, Markus W Büchler, Christoph M Seiler

Protocol for a randomised controlled trial investigating the effectiveness of an online e-health application compared to attention placebo or sertraline in the treatment of generalised anxiety disorder

Helen Christensen, Adam J Guastella, Andrew J Mackinnon, Kathleen M Griffiths, Claire Eagleson, Philip J Batterham, Kanupriya Kalia, Justin Kenardy, Kylie Bennett, Ian B Hickie

Multicenter data acquisition made easy

Jacob Rosenberg, Nadia Abdelaal Henriksen, Lars Nannestad Jørgensen

The SPARK Study: a phase II randomized blinded controlled trial of the effect of furosemide in critically ill patients with early acute kidney injury

Sean M Bagshaw, R T Noel Gibney, Finlay A McAlister, Rinaldo Bellomo

A randomised controlled trial of antiplatelet therapy in combination with Rt-PA thrombolysis in ischemic stroke: rationale and design of the ARTIS-Trial

SM Zinkstok, M Vermeulen, J Stam, RJ de Haan, YB Roos

Assessing the potential for outcome reporting bias in a review: a tutorial

Kerry Dwan, Carrol Gamble, Ruwanthi Kolamunnage-Dona, Shabana Mohammed, Colin Powell, Paula R Williamson

Evaluation of exercise on individuals with dementia and their carers: a randomised controlled trial

Arlinda Cerga-Pashoja, David Lowery, Rahul Bhattacharya, Mark Griffin, Steve Iliffe, James Lee, Claire Leonard, Sue Ricketts, Lyn Strother, Fiona Waters, Craig W Ritchie, James Warner

Design and implementation of a dental caries prevention trial in remote Canadian Aboriginal communities

Rosamund Harrison, Jacques Veronneau, Brian Leroux

Spatial effects should be allowed for in primary care and other community-based cluster RCTS

Paul Silcocks, Denise Kendrick

Case management for patients with chronic systolic heart failure in primary care: The HICMan exploratory randomised controlled trial

Frank Peters-Klimm, Stephen Campbell, Katja Hermann, Cornelia U Kunz, Thomas Müller-Tasch, Joachim Szecsenyi

The Chest Pain Choice trial: a pilot randomized trial of a decision aid for patients with chest pain in the emergency department

Meghan A Pierce, Erik P Hess, Jeffrey A Kline, Nilay D Shah, Maggie Breslin, Megan E Branda, Laurie J Pencille, Brent R Asplin, David M Nestler, Annie T Sadosty, Ian G Stiell, Henry H Ting, Victor M Montori

NEWHINTS cluster randomised trial to evaluate the impact on neonatal mortality in rural Ghana of routine home visits to provide a package of essential newborn care interventions in the third trimester of pregnancy and the first week of life: trial protocol

Betty R Kirkwood, Alexander Manu, Charlotte Tawiah-Agyemang, Guus ten Asbroek, Thomas Gyan, Benedict Weobong, R Eric Lewandowski, Seyi Soremekun, Samuel Danso, Catherine Pitt, Kara Hanson, Seth Owusu-Agyei, Zelee Hill

Reporting on covariate adjustment in randomised controlled trials before and after revision of the 2001 CONSORT statement: a literature review

Ly-Mee Yu, An-Wen Chan, Sally Hopewell, Jonathan J Deeks, Douglas G Altman

Taking Action Together: A YMCA-based protocol to prevent Type-2 Diabetes in high-BMI inner-city African American children

Lorrene D Ritchie, Sushma Sharma, Joanne P Ikeda, Rita A Mitchell, Aarthi Raman, Barbara S Green, Mark L Hudes, Sharon E Fleming

Fluvastatin in the first-line therapy of acute coronary syndrome: results of the multicenter, randomized, double-blind, placebo-controlled trial (the FACS-trial)

Petr Ostadal, David Alan, Jiri Vejvoda, Jiri Kukacka, Milan Macek, Petr Hajek, Martin Mates, Milan Kvapil, Jiri Kettner, Martin Wiendl, Ondrej Aschermann, Josef Slaby, Frantisek Holm, Peter Telekes, David Horak, Peter Blasko, David Zemanek, Josef Veselka, Jana Cepova

Prospective randomized trial evaluating mandatory second look surgery with HIPEC and CRS vs. standard of care in patients at high risk of developing colorectal peritoneal metastases

Robert T Ripley, Jeremy L Davis, Clinton D Kemp, Seth M Steinberg, Mary Ann Toomey, Itzhak Avital

Dementia in residential care: education intervention trial (DIRECT); protocol for a randomised controlled trial

Christopher D Beer, Barbara Horner, Osvaldo P Almeida, Samuel Scherer, Nicola T Lautenschlager, Nick Bretland, Penelope Flett, Frank Schaper, Leon Flicker

Legislation for trial registration and data transparency

Zhao-Xiang Bian, Tai-Xiang Wu

The BRACELET Study: surveys of mortality in UK neonatal and paediatric intensive care trials

Claire Snowdon, Sheila E Harvey, Peter Brocklehurst, Robert C Tasker, Martin P Ward Platt, Elizabeth Allen, Diana Elbourne

Etoricoxib - preemptive and postoperative analgesia (EPPA) in patients with laparotomy or thoracotomy - design and protocols

Johannes Fleckenstein, Sybille Kramer, Martin Offenbächer, Gabriel Schober, Herbert Plischke, Matthias Siebeck, Thomas Mussack, Rudolf Hatz, Lukas Lehmeyer, Philip M Lang, Bernhard Heindl, Peter Conzen, Dominik Irnich

The Viborg vascular (VIVA) screening trial of 65-74 year old men in the central region of Denmark: study protocol

Nikolaj Grøndal, Rikke Søgaard, Eskild W Henneberg, Jes S Lindholt

Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice

STOPFLU: is it possible to reduce the number of days off in office work by improved hand-hygiene?

Carita Savolainen-Kopra, Jaason Haapakoski, Piia A Peltola, Thedi Ziegler, Terttu Korpela, Pirjo Anttila, Ali Amiryousefi, Pentti Huovinen, Markku Huvinen, Heikki Noronen, Pia Riikkala, Merja Roivainen, Petri Ruutu, Juha Teirilä, Erkki Vartiainen, Tapani Hovi

Effects of the dose of erythropoiesis stimulating agents on cardiovascular events, quality of life, and health-related costs in hemodialysis patients: the clinical evaluation of the dose of erythropoietins (C.E. DOSE) trial protocol

Giovanni FM Strippoli

P3MC: A double blind parallel group randomised placebo controlled trial of Propranolol and Pizotifen in preventing migraine in children

Paul Silcocks, Diane Whitham, William Patrick Whitehouse

LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder

Rodolfo N Campos, Luis F Costa, Danielle S Bio, Márcio G Soeiro de Souza, Carla RL Garcia, Frederico N Demétrio, Doris H Moreno, Ricardo A Moreno

Development of an awareness-based intervention to enhance quality of life in severe dementia: trial platform

Linda Clare, Robert T Woods, Rhiannon Whitaker, Barbara A Wilson, Murna Downs

Study protocol: home-based telehealth stroke care: a randomized trial for veterans

Neale R Chumbler, Dorian K Rose, Patricia Griffiths, Patricia Quigley, Nancy McGee-Hernandez, Katherine A Carlson, Phyllis Vandenberg, Miriam C Morey, Jon Sanford, Helen Hoenig

Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine

Ling Wang, Yulin Li, Jing Li, Mingming Zhang, Lin Xu, Wenming Yuan, Gang Wang, Sally Hopewell

A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study

Charity D Evans, Dean T Eurich, Jeff G Taylor, Alfred J Remillard, Yvonne M Shevchuk, David F Blackburn

Problems in the reporting of acne clinical trials: a spot check from the 2009 Annual Evidence Update on Acne Vulgaris

John R Ingram, Douglas JC Grindlay, Hywel C Williams

Managing clinical trials

Barbara Farrell, Sara Kenyon, Haleema Shakur

Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres

Wolfgang Kuchinke, Christian Ohmann, Qin Yang, Nader Salas, Jens Lauritsen, Francois Gueyffier, Alan Leizorovicz, Carmen Schade-Brittinger, Michael Wittenberg, Zoltán Voko, Siobhan Gaynor, Margaret Cooney, Peter Doran, Aldo Maggioni, Andrea Lorimer, Ferràn Torres, Gladys McPherson, Jim Charwill, Mats Hellström, Stéphane Lejeune

Protocol for a phase 1 homeopathic drug proving trial

Michael Teut, Ute Hirschberg, Rainer Luedtke, Cristoph Schnegg, Joern Dahler, Henning Albrecht, Claudia M Witt

Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer - a randomized controlled trial

Anna M Sawka, Sharon Straus, James D Brierley, Richard W Tsang, Lorne Rotstein, Gary Rodin, Amiram Gafni, Shereen Ezzat, Lehana Thabane, Kevin E Thorpe, David P Goldstein

The effects of a muscle resistance program on the functional capacity, knee extensor muscle strength and plasma levels of IL-6 and TNF-α in pre-frail elderly women: a randomized crossover clinical trial - a study protocol

Lygia P Lustosa, Fernanda M Coelho, Juscelio P Silva, Daniele S Pereira, Adriana N Parentoni, João MD Dias, Rosangela C Dias, Leani SM Pereira

Banha-sasim-tang as an herbal formula for the treatment of functional dyspepsia: a randomized, double-blind, placebo-controlled, two-center trial

Jae-Woo Park, Bongha Ryu, Inkwon Yeo, Ui-Min Jerng, Gajin Han, Sunghwan Oh, Jinsoo Lee, Jinsung Kim

Protocol for the adolescent hayfever trial: cluster randomised controlled trial of an educational intervention for healthcare professionals for the management of school-age children with hayfever

Victoria S Hammersley, Samantha Walker, Rob Elton, Aziz Sheikh

Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

David M Kent, Peter M Rothwell, John PA Ioannidis, Doug G Altman, Rodney A Hayward

A randomised controlled trial to evaluate the efficacy of a 6 month dietary and physical activity intervention for prostate cancer patients receiving androgen deprivation therapy

Farhana Haseen, Liam J Murray, Roisin F O'Neill, Joe M O'Sullivan, Marie M Cantwell

Study design and rationale of 'Influence of Cilostazol-based triple anti-platelet therapy on ischemic complication after drug-eluting stent implantation (CILON-T)' study: A multicenter randomized trial evaluating the efficacy of Cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease

Seung-Pyo Lee, Jung-Won Suh, Kyung Woo Park, Hae-Young Lee, Hyun-Jae Kang, Bon-Kwon Koo, In-Ho Chae, Dong-Ju Choi, Seung-Woon Rha, Jang-Whan Bae, Myeong-Chan Cho, Taek-Geun Kwon, Jang-Ho Bae, Hyo-Soo Kim

A cluster randomised controlled trial of the community effectiveness of two interventions in rural Malawi to improve health care and to reduce maternal, newborn and infant mortality

Sonia Lewycka, Charles Mwansambo, Peter Kazembe, Tambosi Phiri, Andrew Mganga, Mikey Rosato, Hilda Chapota, Florida Malamba, Stefania Vergnano, Marie-Louise Newell, David Osrin, Anthony Costello

Rationale and design of EXPLORE: a randomized, prospective, multicenter trial investigating the impact of recanalization of a chronic total occlusion on left ventricular function in patients after primary percutaneous coronary intervention for acute ST-elevation myocardial infarction

René J van der Schaaf, Bimmer E Claessen, Loes P Hoebers, Niels J Verouden, Jacques J Koolen, Maarten J Suttorp, Emanuele Barbato, Matthijs Bax, Bradley H Strauss, Göran K Olivecrona, Vegard Tuseth, Dietmar Glogar, Truls Råmunddal, Jan G Tijssen, Jan J Piek, José PS Henriques

Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration

Andrew J Vickers, Angel M Cronin, Alexandra C Maschino, George Lewith, Hugh Macpherson, Norbert Victor, Karen J Sherman, Claudia Witt, Klaus Linde

A randomized, placebo-controlled, double-blind, prospective trial to evaluate the effect of vildagliptin in new-onset diabetes mellitus after kidney transplantation

Michael Haidinger, Johannes Werzowa, Hans-Christian Voigt, Johannes Pleiner, Gunar Stemer, Manfred Hecking, Dominik Döller, Walter H Hörl, Thomas Weichhart, Marcus D Säemann

Exercise rehabilitation on home-dwelling patients with Alzheimer's disease - a randomized, controlled trial. Study protocol

Kaisu H Pitkala, Minna M Raivio, Marja-Liisa Laakkonen, Reijo S Tilvis, Hannu Kautiainen, Timo E Strandberg

Improving educational achievement and anaemia of school children: design of a cluster randomised trial of school-based malaria prevention and enhanced literacy instruction in Kenya

Simon Brooker, George Okello, Kiambo Njagi, Margaret M Dubeck, Katherine E Halliday, Hellen Inyega, Matthew CH Jukes

Trial Protocol: Randomised controlled trial of the effects of very low calorie diet, modest dietary restriction, and sequential behavioural programme on hunger, urges to smoke, abstinence and weight gain in overweight smokers stopping smoking

Deborah Lycett, Peter Hajek, Paul Aveyard

Study protocol: The Adherence and Intensification of Medications (AIM) study - a cluster randomized controlled effectiveness study

Michele Heisler, Timothy P Hofer, Mandi L Klamerus, Julie Schmittdiel, Joe Selby, Mary M Hogan, Hayden B Bosworth, Adam Tremblay, Eve A Kerr

Brief cognitive behavioral therapy compared to general practitioners care for depression in primary care: a randomized trial

Kim D Baas, Maarten WJ Koeter, Henk C van Weert, Peter Lucassen, Claudi LH Bockting, Karin A Wittkampf, Aart H Schene

Effects of erythropoietin on depressive symptoms and neurocognitive deficits in depression and bipolar disorder

Kamilla W Miskowiak, Maj Vinberg, Catherine J Harmer, Hannelore Ehrenreich, Gitte M Knudsen, Julian Macoveanu, Allan R Hansen, Olaf B Paulson, Hartwig R Siebner, Lars V Kessing

The addition of a goal-based motivational interview to standardised treatment as usual to reduce dropouts in a service for patients with personality disorder: a feasibility study

Mary McMurran, W Miles Cox, Stephen Coupe, Diane Whitham, Lucy Hedges

Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of 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

Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

Sally A Brinkman, Sarah E Johnson, David Lawrence, James P Codde, Michael B Hart, Judith AY Straton, Sven Silburn

Guided self-help on the internet for turkish migrants with depression: the design of a randomized controlled trial

Burçin Ünlü, Heleen Riper, Annemieke van Straten, Pim Cuijpers

CRIMSON [CRisis plan IMpact: Subjective and Objective coercion and eNgagement] Protocol: A randomised controlled trial of joint crisis plans to reduce compulsory treatment of people with psychosis

Graham Thornicroft, Simone Farrelly, Max Birchwood, Max Marshall, George Szmukler, Waquas Waheed, Sarah Byford, Graham Dunn, Claire Henderson, Helen Lester, Morven Leese, Diana Rose, Kim Sutherby

Can a management pathway for chronic cough in children improve clinical outcomes: protocol for a multicentre evaluation

AB Chang, CF Robertson, PP van Asperen, NJ Glasgow, IB Masters, CM Mellis, LI Landau, L Teoh, PS Morris

Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries

Kate Whitfield, Karl-Heinz Huemer, Diana Winter, Steffen Thirstrup, Christian Libersa, Béatrice Barraud, Christine Kubiak, Lea Stankovski, Xina Grählert, Gabriele Dreier, Sebastian Geismann, Wolfgang Kuchinke, Anke Strenge-Hesse, Zsuza Temesvari, Gyorgy Blasko, Gabriella Kardos, Timothy O'Brien, Margaret Cooney, Siobhan Gaynor, Arrigo Schieppati, Mariantonia Serrano, Fernando de Andres, Nuria Sanz, Raquel Hernández, Germán Kreis, Charlotte Asker-Hagelberg, Hanna Johansson, Adeeba Asghar, Jean-Marc Husson, Jacques Demotes, Christian Gluud

Physical activity as a treatment for depression: the TREAD randomised trial protocol

Helen Baxter, Rachel Winder, Melanie Chalder, Christine Wright, Sofie Sherlock, Anne Haase, Nicola J Wiles, Alan A Montgomery, Adrian H Taylor, Ken R Fox, Debbie A Lawlor, Tim J Peters, Deborah J Sharp, John Campbell, Glyn Lewis

The influence of a biopsychosocial-based treatment approach to primary overt hypothyroidism: a protocol for a pilot study

Benjamin T Brown, Rod Bonello, Henry Pollard, Petra Graham

Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol

Tae-Hun Kim, Jung Won Kang, Kun Hyung Kim, Kyung-Won Kang, Mi-Suk Shin, So-Young Jung, Ae-Ran Kim, Hee-Jung Jung, Seung-Deok Lee, Jin-Bong Choi, Sun-Mi Choi

Statistical design of personalized medicine interventions: The Clarification of Optimal Anticoagulation through Genetics (COAG) trial

Benjamin French, Jungnam Joo, Nancy L Geller, Stephen E Kimmel, Yves Rosenberg, Jeffrey L Anderson, Brian F Gage, Julie A Johnson, Jonas H Ellenberg

Comparison of the collagen haemostat Sangustop® versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study

Christian Moench, Wolf O Bechstein, Valentin Hermanutz, Godehard Hoexter, Hanns-Peter Knaebel

Interaction between drug and placebo effects: a cross-over balanced placebo design trial

Muhammad M Hammami, Eman A Al-Gaai, Syed Alvi, Muhammad B Hammami

The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial

Kris Vanhaecht, Walter Sermeus, Jan Peers, Cathy Lodewijckx, Svin Deneckere, Fabrizio Leigheb, Marc Decramer, Massimiliano Panella

Sharing clinical research data in the United States under the health insurance portability and accountability act and the privacy rule

James D Miller

Can herpes simplex virus type 2 suppression slow HIV disease progression: a study protocol for the VALacyclovir In Delaying Antiretroviral Treatment Entry (VALIDATE) trial

Darrell H S Tan, Janet M Raboud, Rupert Kaul, Beatriz Grinsztejn, Pedro Cahn, Sharon L Walmsley

Protocol for a randomised controlled trial of a school based cognitive behaviour therapy (CBT) intervention to prevent depression in high risk adolescents (PROMISE)

Paul Stallard, Alan A Montgomery, Ricardo Araya, Rob Anderson, Glynn Lewis, Kapil Sayal, Rhiannon Buck, Abigail Millings, John A Taylor

A GP caregiver needs toolkit versus usual care in the management of the needs of caregivers of patients with advanced cancer: a randomized controlled trial

Geoffrey Mitchell, Afaf Girgis, Moyez Jiwa, David Sibbritt, Letitia Burridge

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey

Stephen Brealey, Lazaros Andronis, Laura Dennis, Christine Atwell, Stirling Bryan, Simon Coulton, Helen Cox, Ben Cross, Fiona Fylan, Andrew Garratt, Fiona Gilbert, Maureen Gillan, Maggie Hendry, Kerenza Hood, Helen Houston, David King, Veronica Morton, Michael Robling, Ian Russell, Clare Wilkinson

A study of the perceived risks, benefits and barriers to the use of SDD in adult critical care units (The SuDDICU study)

BH Cuthbertson, J Francis, MK Campbell, L MacIntyre, I Seppelt, J Grimshaw

Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial

Michael J Schull, Hastings Banda, Damson Kathyola, Lara Fairall, Alexandra Martiniuk, Barry Burciul, Merrick Zwarenstein, Sumeet Sodhi, Sandy Thompson, Martias Joshua, Martha Mondiwa, Eric Bateman

PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies

Serge Briançon, Emilie Bonsergent, Nelly Agrinier, Sabrina Tessier, Karine Legrand, Edith Lecomte, Evelyne Aptel, Serge Hercberg, Jean-François Collin

The fitness for the Ageing Brain Study II (FABS II): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer's disease

Elizabeth V Cyarto, Kay L Cox, Osvaldo P Almeida, Leon Flicker, David Ames, Gerard Byrne, Keith D Hill, Christopher D Beer, Dina LoGiudice, Kana Appadurai, Muireann Irish, Emma Renehan, Nicola T Lautenschlager

Comparison of heat-sensitive moxibustion versus fluticasone/salmeterol (seretide) combination in the treatment of chronic persistent asthma: design of a multicenter randomized controlled trial

Rixin Chen, Mingren Chen, Jun Xiong, Fan Yi, Zhenhai Chi, Bo Zhang

The prevention of contrast induced nephropathy by sarpogrelate in patients with chronic kidney disease: a study protocol for a prospective randomized controlled clinical trial

Kyungil Park, Woo-Young Chung, Jae-Bin Seo, Sang-Hyun Kim, Joo-Hee Zo, Myung-A Kim, Young-Bae Park

Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

Stefan Klingberg, Andreas Wittorf, Christoph Meisner, Wolfgang Wölwer, Georg Wiedemann, Jutta Herrlich, Andreas Bechdolf, Bernhard W Müller, Gudrun Sartory, Michael Wagner, Tilo Kircher, Hans-Helmut König, Corinna Engel, Gerhard Buchkremer