Issue 1/2010
Content (123 Articles)
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
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
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
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
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