Ausgabe 1/2011
Inhalt (266 Artikel)
A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol
Jesia G Berry, Philip Ryan, Annette J Braunack-Mayer, Katherine M Duszynski, Vicki Xafis, Michael S Gold
Project Masihambisane: a cluster randomised controlled trial with peer mentors to improve outcomes for pregnant mothers living with HIV
Mary-Jane Rotheram-Borus, Linda Richter, Heidi Van Rooyen, Alastair van Heerden, Mark Tomlinson, Alan Stein, Tamsen Rochat, Julia de Kadt, Nonhle Mtungwa, Lungile Mkhize, Lindo Ndlovu, Lungile Ntombela, W Scott Comulada, Katherine A Desmond, Erin Greco
A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization
Elsayed Z Soliman, Shanthi Mendis, Wasantha P Dissanayake, Noel P Somasundaram, Padma S Gunaratne, I Kumudini Jayasingne, Curt D Furberg
International Study to Predict Optimized Treatment for Depression (iSPOT-D), a randomized clinical trial: rationale and protocol
Leanne M Williams, A John Rush, Stephen H Koslow, Stephen R Wisniewski, Nicholas J Cooper, Charles B Nemeroff, Alan F Schatzberg, Evian Gordon
The cameroon mobile phone sms (CAMPS) trial: a protocol for a randomized controlled trial of mobile phone text messaging versus usual care for improving adherence to highly active anti-retroviral therapy
Lawrence Mbuagbaw, Lahana Thabane, Pierre Ongolo-Zogo, Richard T Lester, Edward Mills, Jimmy Volmink, David Yondo, Marie José Essi, Renée-Cecile Bonono-Momnougui, Robert Mba, Jean Serge Ndongo, Francois C Nkoa, Henri Atangana Ondoa
Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot
Deborah A Fitzsimmons, Jill Thompson, Mark Hawley, Gail A Mountain
Accrual and drop out in a primary prevention randomised controlled trial: qualitative study
Helen C Eborall, Marlene CW Stewart, Sarah Cunningham-Burley, Jackie F Price, F Gerry R Fowkes
European society of intensive care medicine study of therapeutic hypothermia (32-35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial)
Peter JD Andrews, Helen Louise Sinclair, Claire G Battison, Kees H Polderman, Giuseppe Citerio, Luciana Mascia, Bridget A Harris, Gordon D Murray, Nino Stocchetti, David K Menon, Haleema Shakur, Daniel De Backer
Investigator experiences with financial conflicts of interest in clinical trials
Paula A Rochon, Melanie Sekeres, John Hoey, Joel Lexchin, Lorraine E Ferris, David Moher, Wei Wu, Sunila R Kalkar, Marleen Van Laethem, Andrea Gruneir, Jennifer Gold, James Maskalyk, David L Streiner, Nathan Taback, An-Wen Chan
Study design and rationale of "Synergistic Effect of Combination Therapy with Cilostazol and ProbUcol on Plaque Stabilization and Lesion REgression (SECURE)" study: a double-blind randomised controlled multicenter clinical trial
Young-Guk Ko, Byeong-Keuk Kim, Byoung Kwon Lee, Woong Chol Kang, Seung Hyuk Choi, Sang Wook Kim, Jong Ho Lee, Myoungsook Lee, Yasuhiro Honda, Peter J Fitzerald, Won-Heum Shim
Protocol for a randomised controlled trial investigating self-help email messages for sub-threshold depression: the Mood Memos study
Amy J Morgan, Anthony F Jorm, Andrew J Mackinnon
Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial
Sudipto Chatterjee, Morven Leese, Mirja Koschorke, Paul McCrone, Smita Naik, Sujit John, Hamid Dabholkar, Kimberley Goldsmith, Madhumitha Balaji, Mathew Varghese, Rangaswamy Thara, Vikram Patel, Graham Thornicroft
Main results of the Ouabain and Adducin for Specific Intervention on Sodium in Hypertension Trial (OASIS-HT): a randomized placebo-controlled phase-2 dose-finding study of rostafuroxin
Jan A Staessen, Lutgarde Thijs, Katarzyna Stolarz-Skrzypek, Antonella Bacchieri, John Barton, Ezio degli Espositi, Peter W de Leeuw, Mirosław Dłużniewski, Nicola Glorioso, Andrzej Januszewicz, Paolo Manunta, Viktor Milyagin, Yuri Nikitin, Miroslav Souček, Chiara Lanzani, Lorena Citterio, Mario Timio, Andrzej Tykarski, Patrizia Ferrari, Giovanni Valentini, Kalina Kawecka-Jaszcz, Giuseppe Bianchi
Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial
Lisa A Harvey, Sarah A Dunlop, Leonid Churilov, Ya-Seng Arthur Hsueh, Mary P Galea
Protocol for a randomized controlled study of Iyengar yoga for youth with irritable bowel syndrome
Subhadra Evans, Laura Cousins, Jennie CI Tsao, Beth Sternlieb, Lonnie K Zeltzer
Effects on patients of their healthcare practitioner's or institution's participation in clinical trials: a systematic review
Mike Clarke, Kirsty Loudon
Does treatment of subsyndromal depression improve depression and diabetes related outcomes: protocol for a randomised controlled comparison of psycho-education, physical exercise and treatment as usual
Mirjana Pibernik-Okanović, Dea Ajduković, Marijana Vučić Lovrenčić, Norbert Hermanns
Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - The SOSTRA trial protocol
Ole Jakob Storebø, Jesper Pedersen, Maria Skoog, Per Hove Thomsen, Per Winkel, Christian Gluud, Erik Simonsen
A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol
Subhadra Evans, Laura Cousins, Jennie CI Tsao, Saskia Subramanian, Beth Sternlieb, Lonnie K Zeltzer
Dutch randomized trial comparing standard catheter-directed thrombolysis versus Ultrasound-accElerated Thrombolysis for thromboembolic infrainguinal disease (DUET): design and rationale
A Marjolein Schrijver, Michel MPJ Reijnen, Jacques A van Oostayen, Rudolf PJ Tutein Nolthenius, Pieter HM van der Valk, Arjan WJ Hoksbergen, Rutger J Lely, Bram Fioole, Dammis Vroegindeweij, Marc van Leersum, Jean-Paul PM de Vries
Impact of early parenteral nutrition completing enteral nutrition in adult critically ill patients (EPaNIC trial): a study protocol and statistical analysis plan for a randomized controlled trial
Michaël P Casaer, Greet Hermans, Alexander Wilmer, Greet Van den Berghe
Design, baseline characteristics, and retention of African American light smokers into a randomized trial involving biological data
Lisa Sanderson Cox, Babalola Faseru, Matthew S Mayo, Ron Krebill, Tricia S Snow, Carrie A Bronars, Nicole L Nollen, Won S Choi, Kolawole S Okuyemi, Gary A Salzman, Neal L Benowitz, Rachel F Tyndale, Jasjit S Ahluwalia
Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening
Michel M Lièvre, Philippe Moulin, Charles Thivolet, Michel Rodier, Vincent Rigalleau, Alfred Penfornis, Alain Pradignac, Michel Ovize
Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S - Scandinavian Starch for Severe Sepsis/Septic Shock trial): Study protocol, design and rationale for a double-blinded, randomised clinical trial
Anders Perner, Nicolai Haase, Jørn Wetterslev, Anders Åneman, Jyrki Tenhunen, Anne Berit Guttormsen, Gudmundur Klemenzson, Frank Pott, Karen Doris Bødker, Per Martin Bådstøløkken, Asger Bendtsen, Peter Søe-Jensen, Hamid Tousi, Morten Bestle, Malgorzata Pawlowicz, Robert Winding, Hans-Henrik Bülow, Claude Kancir, Morten Steensen, Jonas Nielsen, Bjarne Fogh, Kristian R Madsen, Nils H Larsen, Marcela Carlsson, Jørgen Wiis, John Asger Petersen, Susanne Iversen, Ole Schøidt, Siv Leivdal, Pawel Berezowicz, Ville Pettilä, Esko Ruokonen, Pål Klepstad, Sari Karlsson, Maija Kaukonen, Juha Rutanen, Sigurbergur Karason, Anne Lene Kjældgaard, Lars Broksø Holst, Jan Wernerman
Sample size requirements for separating out the effects of combination treatments: Randomised controlled trials of combination therapy vs. standard treatment compared to factorial designs for patients with tuberculous meningitis
Marcel Wolbers, Dorothee Heemskerk, Tran Thi Hong Chau, Nguyen Thi Bich Yen, Maxine Caws, Jeremy Farrar, Jeremy Day
The OPERA trial: protocol for a randomised trial of an exercise intervention for older people in residential and nursing accommodation
Martin Underwood, Sandra Eldridge, Sallie Lamb, Rachel Potter, Bartley Sheehan, Anne-Marie Slowther, Stephanie Taylor, Margaret Thorogood, Scott Weich
The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation
David R Ellard, Stephanie JC Taylor, Suzanne Parsons, Margaret Thorogood
Empowerment of personal injury victims through the internet: design of a randomized controlled trial
Nieke A Elbers, Arno J Akkermans, Pim Cuijpers, David J Bruinvels
Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial
Colin D Chue, Jonathan N Townend, Richard P Steeds, Charles J Ferro
Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial
Thorsten Löffler, Christoph M Seiler, Inga Rossion, Thomas Kijak, Oliver Thomusch, Renè Hodina, Matthias Krüger, Thomas Simon, Thomas Bruckner, Meinhard Kieser, Markus W Büchler, Jürgen Weitz
The incredible years therapeutic dinosaur programme to build social and emotional competence in welsh primary schools: study protocol for a randomised controlled trial
Tracey Bywater, Judy Hutchings, Christopher Whitaker, Ceri Evans, Laura Parry
Reducing the environmental impact of trials: a comparison of the carbon footprint of the CRASH-1 and CRASH-2 clinical trials
Saleena Subaiya, Euan Hogg, Ian Roberts
The effects of centralised and specialised combined pharmacological and psychological intervention compared with decentralised and non-specialised treatment in the early course of severe unipolar and bipolar affective disorders - design of two randomised clinical trials
Lars Vedel Kessing, Hanne Vibe Hansen, Ellen Margrethe Christensen, Henrik Dam, Christian Gluud, Jørn Wetterslev
A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'
Hyun-Jae Kang, Min-Kyung Kim, Myung-Gon Kim, Dong-Ju Choi, Jung-Han Yoon, Young-Bae Park, Hyo-Soo Kim
Cognitive training plus a comprehensive psychosocial programme (OPUS) versus the comprehensive psychosocial programme alone for patients with first-episode schizophrenia (the NEUROCOM trial): A study protocol for a centrally randomised, observer-blinded multi-centre clinical trial
Lone Vesterager, Torben Ø Christensen, Birthe B Olsen, Gertrud Krarup, Hysse B Forchhammer, Marianne Melau, Christian Gluud, Merete Nordentoft
Anger management for people with mild to moderate learning disabilities: Study protocol for a multi-centre cluster randomized controlled trial of a manualized intervention delivered by day-service staff
Paul Willner, Andrew Jahoda, John Rose, Biza Stenfert-Kroese, Kerenza Hood, Julia K Townson, Jacqueline Nuttall, David Gillespie, David Felce
Effectiveness of a structured education reminiscence-based programme for staff on the quality of life of residents with dementia in long-stay units: A study protocol for a cluster randomised trial
Eamon O'Shea, Declan Devane, Kathy Murphy, Adeline Cooney, Dympna Casey, Fionnuala Jordan, Andrew Hunter, Edel Murphy
Effects of Study Design and Allocation on participant behaviour - ESDA: study protocol for a randomized controlled trial
Kypros Kypri, Jim McCambridge, Amanda Wilson, John Attia, Paschal Sheeran, Steve Bowe, Tina Vater
Homeopathy for Depression - DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study
Ubiratan C Adler, Stephanie Krüger, Michael Teut, Rainer Lüdtke, Iris Bartsch, Lena Schützler, Friedericke Melcher, Stefan N Willich, Klaus Linde, Claudia M Witt
A method to study the effect of bronchodilators on smoke retention in COPD patients: study protocol for a randomized controlled trial
WD van Dijk, PTJ Scheepers, R Cremers, JWM Lenders, W Klerx, C van Weel, TRJ Schermer, Y Heijdra
The efficacy and safety study of dietary supplement PURIAM110 on non-insulin taking Korean adults in the stage of pre-diabetes and diabetes mellitus: protocol for a randomized, double-blind, placebo-controlled, and multicenter trial-pilot study
Sunju Park, Jeong-Su Park, Hoyeon Go, Bo-Hyoung Jang, Yongcheol Shin, Seong-Gyu Ko
Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): protocol for the ICEPOC study
Pilar Barnestein-Fonseca, José Leiva-Fernández, Francisca Vidal-España, Antonio García-Ruiz, Daniel Prados-Torres, Francisca Leiva-Fernández
Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial
Giovanni Luca Botto, Giuseppe Boriani, Stefano Favale, Maurizio Landolina, Giulio Molon, Claudio Tondo, Mauro Biffi, Giuseppe Grandinetti, Paolo De Filippo, Giovanni Raciti, Luigi Padeletti
Efficacy of a family practice-based lifestyle intervention program to increase physical activity and reduce clinical and physiological markers of vascular health in patients with high normal blood pressure and/or high normal blood glucose (SNAC): study protocol for a randomized controlled trial
Robert J Petrella, Kuni Aizawa, Kevin Shoemaker, Tom Overend, Len Piche, Mauricio Marin, Sheree Shapiro, Sophie Atkin
Canadian-led capacity-building in biostatistics and methodology in cardiovascular and diabetes trials: the CANNeCTIN Biostatistics and Methodological Innovation Working Group
Lehana Thabane, George Wells, Richard Cook, Robert Platt, Janice Pogue, Eleanor Pullenayegum, David Matthews, Tara McCready, Philip J Devereaux, John A Cairns, Salim Yusuf
Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol
P Knebel, K Schwan, T Bruckner, CM Seiler, K Plaschke, K Streitberger, A Schaible, C Bopp
Conservative management versus open reduction and internal fixation for mid-shaft clavicle fractures in adults - The Clavicle Trial: study protocol for a multicentre randomized controlled trial
Umile Giuseppe Longo, Sughran Banerjee, Julie Barber, Andrew Chambler, Carlos Cobiella, Steven Corbett, Mark Crowther, Steven Drew, Andrea Francis, Marcus Lee, Nicholas Garlick, Iain Packham, Yemi Pearse, Andrew Richards, Chris Roberts, Duncan Tennent, Emily Tims, Philip Michael Ahrens
Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study
Alessandro Montedori, Maria Isabella Bonacini, Giovanni Casazza, Maria Laura Luchetta, Piergiorgio Duca, Francesco Cozzolino, Iosief Abraha
Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial
Jorge Vas, Manuela Modesto, Inmaculada Aguilar, Koldo Santos-Rey, Nicolás Benítez-Parejo, Francisco Rivas-Ruiz
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): study protocol for a randomized double-blind controlled trial
Flávio D Fuchs, Sandra C Fuchs, Leila B Moreira, Miguel Gus, Antônio C Nóbrega, Carlos E Poli-de-Figueiredo, Décio Mion, Luiz Bortolotto, Fernanda Consolim-Colombo, Fernando Nobre, Eduardo Barbosa Coelho, José F Vilela-Martin, Heitor Moreno Jr, Evandro José Cesarino, Roberto Franco, Andréa Araujo Brandão, Marcos R de Sousa, Antônio Luiz Pinho Ribeiro, Paulo Cesar Jardim, Abrahão Afiune Neto, Luiz César N Scala, Marco Mota, Hilton Chaves, João Guilherme Alves, Dario C Sobral Filho, Ricardo Pereira e Silva, José A Figueiredo Neto, Maria Cláudia Irigoyen, Iran Castro, André Avelino Steffens, Rosane Schlatter, Renato Bandeira de Mello, Francisca Mosele, Flávia Ghizzoni, Otávio Berwanger
Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design
Ahmed A Khattab, Stephan Windecker, Peter Jüni, David Hildick-Smith, Dariusz Dudek, Henning R Andersen, Reda Ibrahim, Gerhard Schuler, Antony S Walton, Andreas Wahl, Heinrich P Mattle, Bernhard Meier
Impact on mortality and cancer incidence rates of using random invitation from population registers for recruitment to trials
Matthew Burnell, Aleksandra Gentry-Maharaj, Andy Ryan, Sophia Apostolidou, Mariam Habib, Jatinderpal Kalsi, Steven Skates, Mahesh Parmar, Mourad W Seif, Nazar N Amso, Keith Godfrey, David Oram, Jonathan Herod, Karin Williamson, Howard Jenkins, Tim Mould, Robert Woolas, John Murdoch, Stephen Dobbs, Simon Leeson, Derek Cruickshank, Stuart Campbell, Lesley Fallowfield, Ian Jacobs, Usha Menon
Effect of a single dose of pregabalin on herpes zoster pain
Christina Jensen-Dahm, Michael C Rowbotham, Haatem Reda, Karin Lottrup Petersen
A factorial randomized controlled trial to evaluate the effect of micronutrients supplementation and regular aerobic exercise on maternal endothelium-dependent vasodilatation and oxidative stress of the newborn
Robinson Ramírez-Vélez, Miryam Romero, Isabella Echeverri, José Guillermo Ortega, Mildrey Mosquera, Blanca Salazar, Sandra Lorena Girón, Wilmar Saldarriaga, Ana Cecilia Aguilar de Plata, Julio Cesar Mateus
The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments
Peter Connick, Madhan Kolappan, Rickie Patani, Michael A Scott, Charles Crawley, Xiao-Ling He, Karen Richardson, Kelly Barber, Daniel J Webber, Claudia AM Wheeler-Kingshott, Daniel J Tozer, Rebecca S Samson, David L Thomas, Ming-Qing Du, Shi L Luan, Andrew W Michell, Daniel R Altmann, Alan J Thompson, David H Miller, Alastair Compston, Siddharthan Chandran
An intervention to promote physical activity and self-management in people with stable chronic heart failure The Home-Heart-Walk study: study protocol for a randomized controlled trial
Hui Y Du, Phillip J Newton, Robert Zecchin, Robert Denniss, Yenna Salamonson, Bronwyn Everett, David C Currow, Peter S Macdonald, Patricia M Davidson
A trial on unruptured intracranial aneurysms (the TEAM trial): results, lessons from a failure and the necessity for clinical care trials
Jean Raymond, Tim E Darsaut, Andrew J Molyneux
Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial
Flávio D Fuchs, Sandra C Fuchs, Leila B Moreira, Miguel Gus, Antônio C Nóbrega, Carlos E Poli-de-Figueiredo, Décio Mion, Luiz Bortoloto, Fernanda Consolim-Colombo, Fernando Nobre, Eduardo Barbosa Coelho, José F Vilela-Martin, Heitor Moreno Jr, Evandro José Cesarino, Roberto Franco, Andréa Araujo Brandão, Marcos R de Sousa, Antônio Luiz Pinho Ribeiro, Paulo Cesar Jardim, Abrahão Afiune Neto, Luiz César N Scala, Marco Mota, Hilton Chaves, João Guilherme Alves, Dario C Sobral Filho, Ricardo Pereira e Silva, José A Figueiredo Neto, Maria Cláudia Irigoyen, Iran Castro, André Avelino Steffens, Rosane Schlatter, Renato Bandeira de Mello, Francisca Mosele, Flávia Ghizzoni, Otávio Berwanger
Single-dose liposomal amphotericin B (AmBisome®) for the treatment of Visceral Leishmaniasis in East Africa: study protocol for a randomized controlled trial
Tansy Edwards, Raymond Omollo, Eltahir AG Khalil, Sisay Yifru, Brima Musa, Ahmed Musa, Monique Wasunna, Peter G Smith, Catherine Royce, Sally Ellis, Manica Balasegaram, Asrat Hailu
Recruitment of high risk women for HIV prevention trials: baseline HIV prevalence and sexual behavior in the CAPRISA 004 tenofovir gel trial
Quarraisha Abdool Karim, Ayesha BM Kharsany, Janet A Frohlich, Cheryl Baxter, Nonhlanhla Yende, Leila E Mansoor, Koleka P Mlisana, Silvia Maarschalk, Natasha Arulappan, Anneke Grobler, Sengeziwe Sibeko, Zaheen Omar, Tanuja N Gengiah, Mukelisiwe Mlotshwa, Natasha Samsunder, Salim S Abdool Karim
Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: Study protocol for a pilot randomised controlled trial
Nicola J Hancock, Lee Shepstone, Philip Rowe, Phyo Kyaw Myint, Valerie Pomeroy
A prospective, double-blind, randomized, controlled clinical trial comparing standard wound care with adjunctive hyperbaric oxygen therapy (HBOT) to standard wound care only for the treatment of chronic, non-healing ulcers of the lower limb in patients with diabetes mellitus: a study protocol
Daria O'Reilly, Ron Linden, Ludwik Fedorko, Jean-Eric Tarride, Wilhelmine Giffening Jones, James M Bowen, Ron Goeree
A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial
Karen EA Burns, Clarence Chant, Orla Smith, Brian Cuthbertson, Robert Fowler, Deborah J Cook, Peter Kruger, Steve Webb, Jamal Alhashemi, Guillermo Dominguez-Cherit, Carlos Zala, Gordon D Rubenfeld, John C Marshall
Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol
Hyo-Jung Kwon, Jong-In Kim, Myeong Soo Lee, Jun-Yong Choi, Sungkeel Kang, Jie-Yoon Chung, Young-Jin Kim, Seung-Hoon Lee, Sanghoon Lee, Dongwoo Nam, Yong-Suk Kim, Jae-Dong Lee, Do-Young Choi
Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial
Olaf J Bakker, Hjalmar C van Santvoort, Sandra van Brunschot, Usama Ahmed Ali, Marc G Besselink, Marja A Boermeester, Thomas L Bollen, Koop Bosscha, Menno A Brink, Cornelis H Dejong, Erwin J van Geenen, Harry van Goor, Joos Heisterkamp, Alexander P Houdijk, Jeroen M Jansen, Thom M Karsten, Eric R Manusama, Vincent B Nieuwenhuijs, Bert van Ramshorst, Alexander F Schaapherder, George P van der Schelling, Marcel BM Spanier, Adriaan Tan, Juda Vecht, Bas L Weusten, Ben J Witteman, Louis M Akkermans, Hein G Gooszen
Using a business model approach and marketing techniques for recruitment to clinical trials
Alison M McDonald, Shaun Treweek, Haleema Shakur, Caroline Free, Rosemary Knight, Chris Speed, Marion K Campbell
The effects of an Internet based self-help course for reducing panic symptoms - Don't Panic Online: study protocol for a randomised controlled trial
Wouter van Ballegooijen, Heleen Riper, Annemieke van Straten, Jeannet Kramer, Barbara Conijn, Pim Cuijpers
The effectiveness of simple psychological and exercise interventions for high prevalence mental health problems in young people: a factorial randomised controlled trial
Alexandra G Parker, Sarah E Hetrick, Anthony F Jorm, Alison R Yung, Patrick D McGorry, Andrew Mackinnon, Bridget Moller, Rosemary Purcell
A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION): Rationale and design
Tracey W Tsang, Michael R Kohn, Daniel F Hermens, Simon D Clarke, C Richard Clark, Daryl Efron, Noel Cranswick, Chris Lamb, Leanne M Williams
Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011)
Sangeetha Paramasivan, Robert Huddart, Emma Hall, Rebecca Lewis, Alison Birtle, Jenny L Donovan
The Beta Agonist Lung Injury TrIal (BALTI) - prevention trial protocol
Gavin D Perkins, Daniel Park, Derek Alderson, Matthew W Cooke, Fang Gao, Simon Gates, Sarah E Lamb, Dipesh Mistry, David R Thickett
Interaction and efficacy of Keigai-rengyo-to extract and acupuncture in male patients with acne vulgaris: A study protocol for a randomized controlled pilot trial
Kyu Seok Kim, Yoon-Bum Kim
"Flogging dead horses": evaluating when have clinical trials achieved sufficiency and stability? A case study in cardiac rehabilitation
Louise Dent, Rod Taylor, Kate Jolly, James Raftery
Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial
Christoph Bartl, Dirk Stengel, Thomas Bruckner, Inga Rossion, Steffen Luntz, Christoph Seiler, Florian Gebhard
Standard requirements for GCP-compliant data management in multinational clinical trials
Christian Ohmann, Wolfgang Kuchinke, Steve Canham, Jens Lauritsen, Nader Salas, Carmen Schade-Brittinger, Michael Wittenberg, Gladys McPherson, John McCourt, Francois Gueyffier, Andrea Lorimer, Ferràn Torres
Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia
Marc Buyse, Pierre Squifflet, Kathryn J Lucchesi, Mats L Brune, Sylvie Castaigne, Jacob M Rowe
Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China
Ling Zhao, Fu-wen Zhang, Ying Li, Xi Wu, Hui Zheng, Lin-hao Cheng, Fan-rong Liang
Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery
Richard G Kyle, Bill Culbard, Josie Evans, Nicola M Gray, Dolapo Ayansina, Gill Hubbard
Use of deferred consent for severely ill children in a multi-centre phase III trial
Kathryn Maitland, Sassy Molyneux, Mwamvua Boga, Sarah Kiguli, Trudie Lang
The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial
Marianne Melau, Pia Jeppesen, Anne Thorup, Mette Bertelsen, Lone Petersen, Christian Gluud, Gertrud Krarup, Merete Nordentoft
Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit
Patrick Royston, Friederike M-S Barthel, Mahesh KB Parmar, Babak Choodari-Oskooei, Valerie Isham
Mums 4 Mums: structured telephone peer-support for women experiencing postnatal depression. Pilot and exploratory RCT of its clinical and cost effectiveness
Isabela Caramlau, Jane Barlow, Sukhdev Sembi, Kirstie McKenzie-McHarg, Chris McCabe
Practices, patients and (im)perfect data - feasibility of a randomised controlled clinical drug trial in German general practices
Ildikó Gágyor, Jutta Bleidorn, Karl Wegscheider, Eva Hummers-Pradier, Michael M Kochen
A Meta-analysis of the effects of Exercise Training on Left Ventricular Remodeling Following Myocardial Infarction: Start early and go longer for greatest exercise benefits on remodeling
Mark Haykowsky, Jessica Scott, Ben Esch, Don Schopflocher, Jonathan Myers, Ian Paterson, Darren Warburton, Lee Jones, Alexander M Clark
A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)
Cristina Firanescu, Paul NM Lohle, Jolanda de Vries, Caroline A Klazen, Job R Juttmann, William Clark, Willem Jan van Rooij
Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: rationale and protocol
Anne B Chang, Keith Grimwood, Andrew V White, Carolyn Maclennan, Theo P Sloots, Alan Sive, Gabrielle B McCallum, Ian M Mackay, Peter S Morris
Resources for authors of reports of randomized trials: harnessing the wisdom of authors, editors, and readers
David Moher, Sally Hopewell, Kenneth F Schulz, Douglas G Altman
Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases
Hiroshi Sawata, Kenji Ueshima, Kiichiro Tsutani
Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial
Christopher E Ramsden, J Douglas Mann, Keturah R Faurot, Chanee Lynch, Syed Taha Imam, Beth A MacIntosh, Joseph R Hibbeln, James Loewke, Sunyata Smith, Rebecca Coble, Chirayath Suchindran, Susan A Gaylord
A pseudo-randomised clinical trial of in situ gels of fluconazole for the treatment of oropharngeal candidiasis
Harish M Nairy, Narayana R Charyulu, Veena A Shetty, Prabhu Prabhakara
A Dep ression Re cognition and T reatment package for families living with Stroke (DepReT-Stroke): study protocol for a randomised controlled trial
Richard J Gray, Phyo K Myint, Frances Elender, Garry Barton, Michael Pfeil, Gill Price, Niki Wyatt, Garth Ravenhill, Ester Thomas, Jenny Jagger, Amelia Hursey, Kelly Waterfield, Sheila Hardy
Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study)
Martin C Gulliford, Tjeerd van Staa, Lisa McDermott, Alex Dregan, Gerard McCann, Mark Ashworth, Judith Charlton, Andrew P Grieve, Paul Little, Michael V Moore, Lucy Yardley
Cognitive behaviour therapy (CBT) for anxiety and depression in adults with mild intellectual disabilities (ID): a pilot randomised controlled trial
Angela Hassiotis, Marc Serfaty, Kiran Azam, Andre Strydom, Sue Martin, Charles Parkes, Robert Blizard, Michael King
The methodology for developing a prospective meta-analysis in the family planning community
David K Turok, Eve Espey, Alison B Edelman, Pamela S Lotke, Eva H Lathrop, Stephanie B Teal, Janet C Jacobson, Sara E Simonsen, Kenneth F Schulz
Te Ira Tangata: A Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm
Simon Hatcher, Nicole Coupe, Mason Durie, Hinemoa Elder, Rees Tapsell, Karen Wikiriwhi, Varsha Parag
The International Stroke Trial database
Peter AG Sandercock, Maciej Niewada, Anna Członkowska
Challenges of maintaining research protocol fidelity in a clinical care setting: A qualitative study of the experiences and views of patients and staff participating in a randomized controlled trial
Julia Lawton, Nicholas Jenkins, Julie L Darbyshire, Rury R Holman, Andrew J Farmer, Nina Hallowell
Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery
Sabrine NT Hemmes, Paolo Severgnini, Samir Jaber, Jaume Canet, Hermann Wrigge, Michael Hiesmayr, Edda M Tschernko, Markus W Hollmann, Jan M Binnekade, Göran Hedenstierna, Christian Putensen, Marcelo Gama de Abreu, Paolo Pelosi, Marcus J Schultz
Depression care management for late-life depression in China primary care: Protocol for a randomized controlled trial
Shulin Chen, Yeates Conwell, Baihua Xu, Helen Chiu, Xin Tu, Yan Ma
Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) Protocol
A David Mendelow, Barbara A Gregson, Patrick M Mitchell, Gordon D Murray, Elise N Rowan, Anil R Gholkar
Ethical issues posed by cluster randomized trials in health research
Charles Weijer, Jeremy M Grimshaw, Monica Taljaard, Ariella Binik, Robert Boruch, Jamie C Brehaut, Allan Donner, Martin P Eccles, Antonio Gallo, Andrew D McRae, Raphael Saginur, Merrick Zwarenstein
A cluster-randomized, placebo-controlled, maternal vitamin a or beta-carotene supplementation trial in bangladesh: design and methods
Alain B Labrique, Parul Christian, Rolf DW Klemm, Mahbubur Rashid, Abu Ahmed Shamim, Allan Massie, Kerry Schulze, Andre Hackman, Keith P West Jr
Case management in oncology rehabilitation (CAMON): The effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. A study protocol for a randomized controlled clinical trial in oncology rehabilitation
Irene Bachmann-Mettler, Claudia Steurer-Stey, Oliver Senn, Mathyas Wang, Katarina Bardheci, Thomas Rosemann
Through the looking glass: understanding non-inferiority
Jennifer Schumi, Janet T Wittes
The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data
Alison J Dunkley, Melanie J Davies, Margaret A Stone, Nicholas A Taub, Jacqui Troughton, Thomas Yates, Kamlesh Khunti
Treatment success in pragmatic randomised controlled trials: a review of trials funded by the UK Health Technology Assessment programme
Louise Dent, James Raftery
The effect of family-based multidisciplinary cognitive behavioral treatment in children with obesity: study protocol for a randomized controlled trial
Rimke C Vos, Jan M Wit, Hanno Pijl, Carolien C Kruyff, Euphemia CAM Houdijk
Beta Agonist Lung Injury TrIal-2 (BALTI-2) trial protocol: A randomised, double-blind, placebo-controlled of intravenous infusion of salbutamol in the acute respiratory distress syndrome
Gavin D Perkins, Simon Gates, Sarah E Lamb, Chris McCabe, Duncan Young, Fang Gao
The STRATOB study: design of a randomized controlled clinical trial of Cognitive Behavioral Therapy and Brief Strategic Therapy with telecare in patients with obesity and binge-eating disorder referred to residential nutritional rehabilitation
Gianluca Castelnuovo, Gian Mauro Manzoni, Valentina Villa, Gian Luca Cesa, Giada Pietrabissa, Enrico Molinari
Does clinical equipoise apply to cluster randomized trials in health research?
Ariella Binik, Charles Weijer, Andrew D McRae, Jeremy M Grimshaw, Robert Boruch, Jamie C Brehaut, Allan Donner, Martin P Eccles, Raphael Saginur, Monica Taljaard, Merrick Zwarenstein
Study protocol for the recreational stimulation for elders as a vehicle to resolve delirium superimposed on dementia (Reserve For DSD) trial
Ann M Kolanowski, Donna M Fick, Mark S Litaker, Linda Clare, Doug Leslie, Malaz Boustani
Design paper: A phase II study of Bevacizumab and Erlotinib in patients with non-Squamous non-small cell lung cancer that is refractory or relapsed after 1-2 previous Treatment (BEST)
Shiro Tanaka, Yuichi Sakamori, Miyuki Niimi, Megumi Hazama, Young H Kim, Kazuhiro Yanagihara
Study protocol: ICONS: Identifying continence options after stroke: A randomised trial
Lois H Thomas, Caroline L Watkins, Beverley French, Christopher Sutton, Denise Forshaw, Francine Cheater, Brenda Roe, Michael J Leathley, Christopher Burton, Elaine McColl, Jo Booth
Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial
Laura B Allen, Jennie CI Tsao, Loran P Hayes, Lonnie K Zeltzer
Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional chinese medicine RCTs: A review of 3159 RCTs identified from 260 systematic reviews
Jia He, Liang Du, Guanjian Liu, Jin Fu, Xiangyu He, Jiayun Yu, Lili Shang
Study Protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease
Morag C Farquhar, A Toby Prevost, Paul McCrone, Irene J Higginson, Jennifer Gray, Barbara Brafman-Kennedy, Sara Booth
Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial
Elizabeth P Tolmie, Eleanor M Dinnett, Elizabeth S Ronald, Allan Gaw
Evaluation of a Medical and Mental Health Unit compared with standard care for older people whose emergency admission to an acute general hospital is complicated by concurrent 'confusion': a controlled clinical trial. Acronym: TEAM: Trial of an Elderly Acute care Medical and mental health unit
Rowan H Harwood, Sarah E Goldberg, Kathy H Whittamore, Catherine Russell, John RF Gladman, Rob G Jones, Davina Porock, Sarah A Lewis, Lucy E Bradshaw, Rachel A Elliot
Culturally-Tailored Smoking Cessation for American Indians: Study protocol for a randomized controlled trial
Won S Choi, Babalola Faseru, Laura A Beebe, Allen K Greiner, Hung-Wen Yeh, Theresa I Shireman, Myrietta Talawyma, Lance Cully, Baljit Kaur, Christine M Daley
The ACCESS study a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in people who present to hospital after self-harm: study protocol for a randomised controlled trial
Simon Hatcher, Cynthia Sharon, Allan House, Sunny Collings, Varsha Parag, Nicola Collins
Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial
Jeremy L Davis, Prakash Pandalai, R Taylor Ripley, Russell C Langan, Seth M Steinberg, Melissa Walker, Mary Ann Toomey, Elliot Levy, Itzhak Avital
Strategic use of new generation antidepressants for depression: SUN(^_^)D study protocol
Toshi A Furukawa, Tatsuo Akechi, Shinji Shimodera, Mitsuhiko Yamada, Kazuhira Miki, Norio Watanabe, Masatoshi Inagaki, Naohiro Yonemoto
Community mobilisation and health management committee strengthening to increase birth attendance by trained health workers in rural Makwanpur, Nepal: study protocol for a cluster randomised controlled trial
Joanna Morrison, Kirti Man Tumbahangphe, Bharat Budhathoki, Rishi Neupane, Aman Sen, Kunta Dahal, Rita Thapa, Reema Manandhar, Dharma Manandhar, Anthony Costello, David Osrin
The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE): study protocol for a randomized controlled trial
Augusto Azuara-Blanco, Jennifer M Burr, Claire Cochran, Craig Ramsay, Luke Vale, Paul Foster, David Friedman, Zahidul Quayyum, Jimmy Lai, Winnie Nolan, Tin Aung, Paul Chew, Gladys McPherson, Alison McDonald, John Norrie
The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial
Andrew Clegg, Sally Barber, John Young, Anne Forster, Steve Iliffe
To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial
Margaret Pinder, Musa Jawara, Lamin BS Jarju, Ballah Kandeh, David Jeffries, Manuel F Lluberas, Jenny Mueller, David Parker, Kalifa Bojang, David J Conway, Steve W Lindsay
A traditional Chinese medicine versus Western combination therapy in the treatment of rheumatoid arthritis: two-stage study protocol for a randomized controlled trial
Chi Zhang, Miao Jiang, Aiping Lu
Improving delirium care in the intensive care unit: The design of a pragmatic study
Noll L Campbell, Babar A Khan, Mark Farber, Tiffany Campbell, Anthony J Perkins, Siu L Hui, Greg Abernathy, John Buckley, Regg Sing, Jason Tricker, Mohammad Zawahiri, Malaz A Boustani
Transfer of manualized Short Term Psychodynamic Psychotherapy (STPP) for social phobia into clinical practice: study protocol for a cluster-randomised controlled trial
Jörg Wiltink, Christian Ruckes, Antje Haselbacher, Marco Canterino, Falk Leichsenring, Peter Joraschky, Frank Leweke, Karin Pöhlmann, Manfred E Beutel
Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial
Roger M Beadle, Lynne K Williams, Khaild Abozguia, Kiran Patel, Francisco Leyva Leon, Zaheer Yousef, Anton Wagenmakers, Michael P Frenneaux
Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication
Roger J Lewis, Jason T Connor, John R Teerlink, James R Murphy, Leslie T Cooper, William R Hiatt, Eric P Brass
Comparison of early-, late-, and non-participants in a school-based asthma management program for urban high school students
Christine LM Joseph, Jacquelyn Saltzgaber, Suzanne L Havstad, Christine C Johnson, Dayna Johnson, Edward L Peterson, Gwen Alexander, Mick P Couper, Dennis R Ownby
The UK clinical research network - has it been a success for dermatology clinical trials?
Kim S Thomas, Karin Koller, Katharine Foster, Jo Perdue, Lisa Charlesworth, Joanne R Chalmers
Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions
Sarah E Lamb, Clemens Becker, Lesley D Gillespie, Jessica L Smith, Susanne Finnegan, Rachel Potter, Klaus Pfeiffer
Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in uganda: study protocol
Nicola J Robertson, Cornelia F Hagmann, Dominique Acolet, Elizabeth Allen, Natasha Nyombi, Diana Elbourne, Anthony Costello, Ian Jacobs, Margaret Nakakeeto, Frances Cowan
Analysis and design of randomised clinical trials involving competing risks endpoints
Bee-Choo Tai, Joseph Wee, David Machin
Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial
Bhim P Shrestha, Bishnu Bhandari, Dharma S Manandhar, David Osrin, Anthony Costello, Naomi Saville
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
Prevention of: self harm in British South Asian women: study protocol of an exploratory RCT of culturally adapted manual assisted Problem Solving Training (C- MAP)
Nusrat Husain, Nasim Chaudhry, Steevart V Durairaj, Imran Chaudhry, Sarah Khan, Meher Husain, Diwaker Nagaraj, Farooq Naeem, Waquas Waheed
The challenges and opportunities of conducting a clinical trial in a low resource setting: The case of the Cameroon mobile phone SMS (CAMPS) trial, an investigator initiated trial
Lawrence Mbuagbaw, Lehana Thabane, Pierre Ongolo-Zogo, Trudie Lang
Social validity of randomised controlled trials in health services research and intellectual disabilities: a qualitative exploration of stakeholder views
Dan Robotham, Michael King, Anton Canagasabey, Sophie Inchley-Mort, Angela Hassiotis
Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial
Jong-In Kim, Tae-Hun Kim, Myeong Soo Lee, Jung Won Kang, Kun Hyung Kim, Jun-Yong Choi, Kyung-Won Kang, Ae-Ran Kim, Mi-Suk Shin, So-Young Jung, Sun-mi Choi
A post-trial survey to assess the impact of dissemination of results and unmasking on participants in a 13-year randomised controlled trial on age-related cataract
Sally L Williams, Luigina Ferrigno, Giovanni Maraini, Francesco Rosmini, Robert D Sperduto
Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial
Wendy V Norman, Janusz Kaczorowski, Judith A Soon, Rollin Brant, Stirling Bryan, Konia J Trouton, Lyda Dicus
Effectiveness, relapse prevention and mechanisms of change of cognitive therapy vs. interpersonal therapy for depression: Study protocol for a randomised controlled trial
Lotte HJM Lemmens, Arnoud Arntz, Frenk PML Peeters, Steven D Hollon, Anne Roefs, Marcus JH Huibers
Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications
Christina Pagel, Audrey Prost, Sonia Lewycka, Sushmita Das, Tim Colbourn, Rajendra Mahapatra, Kishwar Azad, Anthony Costello, David Osrin
Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial
Lisa Shaw, Christopher Price, Sally McLure, Denise Howel, Elaine McColl, Gary A Ford
Evaluation of the Frails' Fall Efficacy by Comparing Treatments (EFFECT) on reducing fall and fear of fall in moderately frail older adults: study protocol for a randomised control trial
Boon Chong Kwok, Kaysar Mamun, Manju Chandran, Chek Hooi Wong
Individually integrated traditional chinese medicine approach in the management of knee osteoarthritis: study protocol for a randomized controlled trial
Cao Yuelong, Zhan Hongsheng, Pang Jian, Li Feiyue, Xu Shaojian, Gao Jinghua, Xu Zhanwang, Li Gang, Liu Ting, Guo Chaoqing, Shi Yinyu
Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]
Tobias Freund, Frank Peters-Klimm, Justine Rochon, Cornelia Mahler, Jochen Gensichen, Antje Erler, Martin Beyer, Annika Baldauf, Ferdinand M Gerlach, Joachim Szecsenyi
PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES): study protocol for a randomised controlled trial
Judith L Meijer, Claudi LH Bockting, Chantal Beijers, Tjitte Verbeek, A Dennis Stant, Johan Ormel, Ronald P Stolk, Peter de Jonge, Mariëlle G van Pampus, Huibert Burger
Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: Study protocol for a randomized controlled trial
Aurélie Beslot-Neveu, Eric Bonte, Bruno Baune, Raphaël Serreau, Fawzia Aissat, Laurent Quinquis, Sophie Grabar, Jean-Jacques Lasfargues
LigaSure Impact™ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial
Tobias Gehrig, Phillip Knebel, Verena Scheel, Ulf Hinz, Christoph M Seiler, Beat P Müller-Stich, Markus W Büchler, Carsten N Gutt
Bath Breakfast Project (BBP) - Examining the role of extended daily fasting in human energy balance and associated health outcomes: Study protocol for a randomised controlled trial [ISRCTN31521726]
James A Betts, Dylan Thompson, Judith D Richardson, Enhad A Chowdhury, Matthew Jeans, Geoffrey D Holman, Kostas Tsintzas
Exercise Training in Pregnancy for obese women (ETIP): study protocol for a randomised controlled trial
Trine T Moholdt, Kjell Salvesen, Charlotte B Ingul, Torstein Vik, Emily Oken, Siv Mørkved
Comprehensive early intervention for patients with first-episode psychosis in Japan (J-CAP): study protocol for a randomised controlled trial
Shinsuke Koike, Atsushi Nishida, Syudo Yamasaki, Kayo Ichihashi, Sanae Maegawa, Tatsunobu Natsubori, Hirohiko Harima, Kiyoto Kasai, Izumi Fujita, Masanori Harada, Yuji Okazaki
Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial
David G Wilder, Robert D Vining, Katherine A Pohlman, William C Meeker, Ting Xia, James W DeVocht, R Maruti Gudavalli, Cynthia R Long, Edward F Owens, Christine M Goertz
The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial
Jacquie White, Richard J Gray, Louise Swift, Garry R Barton, Martin Jones
Acupuncture for attention deficit hyperactivity disorder (ADHD): study protocol for a randomised controlled trial
Soon-Sang Hong, Seung-Hun Cho
Improving mood with psychoanalytic and cognitive therapies (IMPACT): a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial
Ian M Goodyer, Sonya Tsancheva, Sarah Byford, Bernadka Dubicka, Jonathan Hill, Raphael Kelvin, Shirley Reynolds, Christopher Roberts, Robert Senior, John Suckling, Paul Wilkinson, Mary Target, Peter Fonagy
Panax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD): study protocol for a randomised controlled trial
Charlie C Xue, Johannah L Shergis, Anthony L Zhang, Christopher Worsnop, Harry Fong, David Story, Cliff Da Costa, Francis CK Thien
INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing
Megan Murdoch, Elaine McColl, Denise Howel, Mark Deverill, Brian S Buckley, Malcolm Lucas, Christopher R Chapple, Douglas G Tincello, Natalie Armstrong, Cath Brennand, Jing Shen, Luke Vale, Paul Hilton
Stepped care treatment for depression and anxiety in primary care. a randomized controlled trial
Wike Seekles, Annemieke van Straten, Aartjan Beekman, Harm van Marwijk, Pim Cuijpers
Inhaled nitric oxide for the adjunctive therapy of severe malaria: Protocol for a randomized controlled trial
Michael Hawkes, Robert O Opoka, Sophie Namasopo, Christopher Miller, Kevin E Thorpe, James V Lavery, Andrea L Conroy, W Conrad Liles, Chandy C John, Kevin C Kain
TREC-SAVE: a randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people: study protocol for a randomised controlled trial
Gisele Huf, Evandro SF Coutinho, Marco AV Ferreira, Silvana Ferreira, Flavia Mello, Clive E Adams
Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke
Marian C Brady, David J Stott, John Norrie, Campbell Chalmers, Bridget St George, Petrina M Sweeney, Peter Langhorne
Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics: study protocol for a randomised controlled trial - The PINOCCHIO trial
Federico Bilotta, Andrea Doronzio, Elisabetta Stazi, Luca Titi, Ivan Orlando Zeppa, Antonella Cianchi, Giovanni Rosa, Francesca Paola Paoloni, Sergio Bergese, Irene Asouhidou, Polimnia Ioannou, Apolonia Elisabeth Abramowicz, Allison Spinelli, Ellise Delphin, Eugenia Ayrian, Vladimir Zelman, Philip Lumb
Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial
Raymond Omollo, Neal Alexander, Tansy Edwards, Eltahir AG Khalil, Brima M Younis, Abuzaid A Abuzaid, Monique Wasunna, Njenga Njoroge, Dedan Kinoti, George Kirigi, Thomas PC Dorlo, Sally Ellis, Manica Balasegaram, Ahmed M Musa
SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial
Mare MA Lensvelt, Suzanne Holewijn, Wilbert M Fritschy, Otmar RM Wikkeling, Laurens A van Walraven, Bas M Wallis de Vries, Clark J Zeebregts, Michel MPJ Reijnen
Reporting of factorial trials of complex interventions in community settings: a systematic review
Alan A Montgomery, Margaret P Astin, Tim J Peters
The Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial: study protocol for a randomized controlled trial
Debbie A Lawlor, Russell Jago, Sian M Noble, Catherine R Chittleborough, Rona Campbell, Julie Mytton, Laura D Howe, Tim J Peters, Ruth R Kipping
minSKIN Does a m ultifaceted in tervention improve the competence in the diagnosis of skin cancer by general practitioners? Study protocol for a randomised controlled trial
Nina Badertscher, Thomas Rosemann, Ryan Tandjung, Ralph P Braun
Rationale and design of the plate or pin (pop) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial
Frans JG Wijdicks, R Marijn Houwert, Marcel GW Dijkgraaf, Diederik H De Lange, Sven AG Meylaerts, Michiel HJ Verhofstad, Egbert JJM Verleisdonk
Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs) to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial
Prasanta Tripathy, Nirmala Nair, Rajendra Mahapatra, Shibanand Rath, Raj Kumar Gope, Suchitra Rath, Aparna Bajpai, Vijay Singh, Vikash Nath, Sarfraz Ali, Alok Kumar Kundu, Dibarkar Choudhury, Sanjib Ghosh, Swati Sarbani, Rajesh Sinha, Christina Pagel, Anthony Costello, Tanja AJ Houweling, Audrey Prost
Who is the research subject in cluster randomized trials in health research?
Andrew D McRae, Charles Weijer, Ariella Binik, Angela White, Jeremy M Grimshaw, Robert Boruch, Jamie C Brehaut, Allan Donner, Martin P Eccles, Raphael Saginur, Merrick Zwarenstein, Monica Taljaard
A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda
Lubega Muhamadi, Nazarius M Tumwesigye, Daniel Kadobera, Gaetano Marrone, Fred Wabwire-Mangen, George Pariyo, Stefan Peterson, Anna Mia Ekström
The Risk of Paradoxical Embolism (RoPE) Study: Developing risk models for application to ongoing randomized trials of percutaneous patent foramen ovale closure for cryptogenic stroke
David M Kent, David E Thaler
Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial
Feng Yang, De-Zhi Tang, Xue-Jun Cui, Jonathan D Holz, Qin Bian, Qi Shi, Yong-Jun Wang
Response to: Pre-referral rectal artesunate in severe malaria: a flawed trial
Melba F Gomes
Erratum to: 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
Effectiveness of an online group course for adolescents and young adults with depressive symptoms: study protocol for a randomized controlled trial
Rianne AP van der Zanden, Jeannet JAM Kramer, Pim Cuijpers
Between-centre differences and treatment effects in randomized controlled trials: A case study in traumatic brain injury
Hester F Lingsma, Bob Roozenbeek, Pablo Perel, Ian Roberts, Andrew IR Maas, Ewout W Steyerberg
Pre-referral rectal artesunate in severe malaria: flawed trial
Karim F Hirji, Zulfiqarali G Premji
Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: A pragmatic multi-site community-based randomised clinical trial
Mary McMurran, Mike J Crawford, Joseph G Reilly, Paul McCrone, Paul Moran, Hywel Williams, Clive E Adams, Conor Duggan, Juan Delport, Diane Whitham, Florence Day
Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial
Anders Thornell, Eva Angenete, Elisabeth Gonzales, Jane Heath, Per Jess, Zoltan Läckberg, Henrik Ovesen, Jacob Rosenberg, Stefan Skullman, Eva Haglind
Can an online clinical data management service help in improving data collection and data quality in a developing country setting?
Maarten A Wildeman, Jeroen Zandbergen, Andrew Vincent, Camelia Herdini, Jaap M Middeldorp, Renske Fles, Otilia Dalesio, Emile van der Donk, I Bing Tan
Randomized, double-blind, placebo-controled clinical trial of sublingual immunotherapy in natural rubber latex allergic patients
Gabriel Gastaminza, Jaime Algorta, Olga Uriel, Maria T Audicana, Eduardo Fernandez, Maria L Sanz, Daniel Muñoz
A meta-review of evidence on heart failure disease management programs: the challenges of describing and synthesizing evidence on complex interventions
Lori A Savard, David R Thompson, Alexander M Clark
Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers
Rachna A Begh, Paul Aveyard, Penney Upton, Raj S Bhopal, Martin White, Amanda Amos, Robin J Prescott, Raman Bedi, Pelham Barton, Monica Fletcher, Paramjit Gill, Qaim Zaidi, Aziz Sheikh
Simultaneous use of traditional Chinese medicine (Si-Ni-Tang) to treat septic shock patients: study protocol for a randomized controlled trial
Huang-Chi Chen, Wen-Chi Chen, Kai-Huang Lin, Yung-Hsiang Chen, Lun-Chien Lo, Tsung-Chieh Lee, Te-Chun Hsia, Chu-Hsien Wang, Shin-Hwar Wu, Hsin-Whae Hsu, Yu-Jun Chang, Yu-Chuen Huang, Tien-Hsiung Ku, Ming-Hwarng Horng
Illness management and recovery (IMR) in Danish community mental health centres
Helle Stentoft Dalum, Lisa Korsbek, John Hagel Mikkelsen, Karin Thomsen, Kristen Kistrup, Mette Olander, Jane Lindschou Hansen, Merete Nordentoft, Lene Falgaard Eplov
EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial
Jürgen Bardutzky, Jens Witsch, Eric Jüttler, Stefan Schwab, Peter Vajkoczy, Stefan Wolf
Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial
Georgina Charlesworth, Karen Burnell, Jennifer Beecham, Zoë Hoare, Juanita Hoe, Jennifer Wenborn, Martin Knapp, Ian Russell, Bob Woods, Martin Orrell
Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial
Julius Kamwesiga, Vincent Mutabazi, Josephine Kayumba, Jean-Claude K Tayari, Richard Smyth, Heather Fay, Alice Umurerwa, Marcel Baziruwiha, Christian Ntizimira, Antoinette Murebwayire, Jean Pierre Haguma, Julienne Nyiransabimana, Donatille Habarurema, Veneranda Mukarukundo, Jean Bosco Nzabandora, Pascal Nzamwita, Ernestine Mukazayire, Edward J Mills, Dugald Seely, Douglas J McCready, Don Warren
Cardiac magnetic resonance imaging parameters as surrogate endpoints in clinical trials of acute myocardial infarction
Steffen Desch, Ingo Eitel, Suzanne de Waha, Georg Fuernau, Philipp Lurz, Matthias Gutberlet, Gerhard Schuler, Holger Thiele
Acute medical unit comprehensive geriatric assessment intervention study (AMIGOS)
Judi Edmans, Simon Conroy, Rowan Harwood, Sarah Lewis, Rachel A Elliott, Philippa Logan, Lucy Bradshaw, Matthew Franklin, John Gladman
When is informed consent required in cluster randomized trials in health research?
Andrew D McRae, Charles Weijer, Ariella Binik, Jeremy M Grimshaw, Robert Boruch, Jamie C Brehaut, Allan Donner, Martin P Eccles, Raphael Saginur, Angela White, Monica Taljaard
Transfusion of red cells in hematopoietic stem cell transplantation (TRIST): study protocol for a randomized controlled trial
Jason Tay, Alan Tinmouth, Dean Fergusson, David Allan
Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial
Madhukar H Trivedi, Tracy L Greer, Bruce D Grannemann, Timothy S Church, Eugene Somoza, Steven N Blair, Jose Szapocznik, Mark Stoutenberg, Chad Rethorst, Diane Warden, Kolette M Ring, Robrina Walker, David W Morris, Andrzej S Kosinski, Tiffany Kyle, Bess Marcus, Becca Crowell, Neal Oden, Edward Nunes
The use of LiDCO based fluid management in patients undergoing hip fracture surgery under spinal anaesthesia: Neck of femur optimisation therapy - targeted stroke volume (NOTTS): study protocol for a randomized controlled trial
Matthew D Wiles, William JD Whiteley, Chris G Moran, Iain K Moppett
Efficacy of electroacupuncture at Zhongliao point (BL33) for mild and moderate benign prostatic hyperplasia: study protocol for a randomized controlled trial
Yang Wang, Zhishun Liu, Jinna Yu, Yulong Ding, Xuan Liu
Failure to report protocol violations in clinical trials: a threat to internal validity?
Elizabeth A Sweetman, Gordon S Doig
Meropenem vs standard of care for treatment of late onset sepsis in children of less than 90 days of age: study protocol for a randomised controlled trial
Irja Lutsar, Ursula MT Trafojer, Paul T Heath, Tuuli Metsvaht, Joseph Standing, Susanna Esposito, Vincent Meiffredy de Cabre, Clarissa Oeser, Jean-Pierre Aboulker
DIABRISK - SL Prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's - study protocol for a randomized controlled trial
Mahen Wijesuriya, Martin Gulliford, Laksha Vasantharajah, Giancarlo Viberti, Luigi Gnudi, Janaka Karalliedde
The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial
Tanja AJ Houweling, Kishwar Azad, Layla Younes, Abdul Kuddus, Sanjit Shaha, Bedowra Haq, Tasmin Nahar, James Beard, Edward F Fottrell, Audrey Prost, Anthony Costello
Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial
Seok-Jae Ko, Bongha Ryu, Jinsung Kim, Beom-Gi Hong, Inkwon Yeo, Beom-Joon Lee, Jin-Moo Lee, Jae-Woo Park
The effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur fracture - The CAESAR study: study protocol for a randomized controlled trial
Marjolein Heeres, Tjaakje Visser, Karlijn JP van Wessem, Anky HL Koenderman, Paul FW Strengers, Leo Koenderman, Luke PH Leenen
Reduction of surgical site infection using a novel intervention (ROSSINI): study protocol for a randomised controlled trial
Thomas D Pinkney, David C Bartlett, William Hawkins, Tony Mak, Haney Youssef, Kaori Futaba, Gareth Harrison, Adrian Gheorghe, Jennifer M Bradbury, Melanie J Calvert, George Dowswell, Laura Magill, Val Redman, Sue Wilson, David Leaper, Dion G Morton
Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians)
Anne Douglas, Raj S Bhopal, Ruby Bhopal, John F Forbes, Jason MR Gill, Julia Lawton, John McKnight, Gordon Murray, Naveed Sattar, Anu Sharma, Jaakko Tuomilehto, Sunita Wallia, Sarah H Wild, Aziz Sheikh
A randomised evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER): study protocol for a randomized controlled trial
Natasha Mitchell, Catherine Hewitt, Joy Adamson, Steve Parrott, David Torgerson, David Ekers, John Holmes, Helen Lester, Dean McMillan, David Richards, Karen Spilsbury, Christine Godfrey, Simon Gilbody
Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery
Lukasz J Krzych, Belinda Lees, Fiona Nugara, Winston Banya, Andrzej Bochenek, Jo Cook, David Taggart, Marcus D Flather
Multi-professional clinical medication reviews in care homes for the elderly: study protocol for a randomised controlled trial with cost effectiveness analysis
James Desborough, Julie Houghton, John Wood, David Wright, Richard Holland, Tracey Sach, Sue Ashwell, Val Shaw
Combined STN/SNr-DBS for the treatment of refractory gait disturbances in Parkinson's disease: study protocol for a randomized controlled trial
Daniel Weiss, Tobias Wächter, Christoph Meisner, Melanie Fritz, Alireza Gharabaghi, Christian Plewnia, Sorin Breit, Rejko Krüger
Effectiveness of heat-sensitive moxibustion in the treatment of lumbar disc herniation: study protocol for a randomized controlled trial
Mingren Chen, Rixin Chen, Jun Xiong, Fan Yi, Zhenhai Chi, Bo Zhang
Alzheimer's disease - input of vitamin D with mEmantine assay (AD-IDEA trial): study protocol for a randomized controlled trial
Cédric Annweiler, Bruno Fantino, Elsa Parot-Schinkel, Samuel Thiery, Jennifer Gautier, Olivier Beauchet
Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial
Dionne Kessing, Johan Denollet, Jos Widdershoven, Nina Kupper
Effectiveness evaluation of an integrated automatic termomechanic massage system (SMATH® system) in non-specific sub-acute and chronic low back pain - a randomized double-blinded controlled trial, comparing SMATH therapy versus sham therapy: study protocol for a randomized controlled trial
Paolo Buselli, Roberto Bosoni, Gabriella Busè, Paola Fasoli, Elide La Scala, Rita Mazzolari, Federica Zanetti, Sara Messina
The chronic care for age-related macular degeneration study (CHARMED): Study protocol for a randomized controlled trial
Anja Frei, Katja Woitzek, Mathyas Wang, Ulrike Held, Thomas Rosemann
Oxygen persufflation as adjunct in liver preservation (OPAL): Study protocol for a randomized controlled trial
Thomas Minor, Carolin Pütter, Anja Gallinat, Claudia Ose, Gernot Kaiser, Andre Scherag, Jürgen Treckmann, Andreas Paul
Which dressing do donor site wounds need?: study protocol for a randomized controlled trial
Anne M Eskes, Fleur E Brölmann, Louise AA Gerbens, Dirk T Ubbink, Hester Vermeulen
Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial
Leonard E Egede, Joni L Strom, Jyotika Fernandes, Rebecca G Knapp, Adebola Rojugbokan
The efficacy of a brief intervention in reducing hazardous drinking in working age men in Russia: the HIM (Health for Izhevsk men) individually randomised parallel group exploratory trial
Elizabeth Allen, Olga Polikina, Lyudmila Saburova, Jim McCambridge, Diana Elbourne, Sergey Pakriev, Nadezhda Nekrasova, Maxim Vasilyev, Keith Tomlin, Alexey Oralov, Artyom Gil, Martin McKee, Nikolay Kiryanov, David A Leon
Collaborative research between academia and industry using a large clinical trial database: a case study in Alzheimer's disease
Roy Jones, David Wilkinson, Oscar L Lopez, Jeffrey Cummings, Gunhild Waldemar, Richard Zhang, Joan Mackell, Serge Gauthier
Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial
Bruce F Walker, Barrett Losco, Brenton R Clarke, Jeff Hebert, Simon French, Norman J Stomski
Corticotherapy for traumatic brain-injured Patients - The Corti-TC trial: study protocol for a randomized controlled trial
Karim Asehnoune, Antoine Roquilly, Véronique Sebille
The use of carer assisted adherence therapy for people with Parkinson's disease and their carers (CAAT-PARK): study protocol for a randomised controlled trial
David J Daley, Katherine HO Deane, Richard J Gray, Paul F Worth, Allan B Clark, Kanagasabesan Sabanathan, Michael Pfeil, Phyo K Myint
Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction (EXAMI): study protocol for a randomized controlled trial
Martijn Scholte, Leo Timmers, Flip JP Bernink, Robert N Denham, Aernout M Beek, Otto Kamp, Michaela Diamant, Anton JG Horrevoets, Hans WM Niessen, Weena JY Chen, Albert C van Rossum, Niels van Royen, Pieter A Doevendans, Yolande Appelman
Everolimus and long acting octreotide as a volume reducing treatment of polycystic livers (ELATE): study protocol for a randomized controlled trial
Melissa Chrispijn, Joost PH Drenth
The impact of dose of the angiotensin-receptor blocker valsartan on the post-myocardial infarction ventricular remodeling: study protocol for a randomized controlled trial
Young-Rak Cho, Young-Dae Kim, Tae-Ho Park, Kyungil Park, Jong-Sung Park, Heekyung Baek, Sun-Young Choi, Kee-Sik Kim, Taek-Jong Hong, Tae-Hyun Yang, Jin-Yong Hwang, Jong-Seon Park, Seung-Ho Hur, Sang-Gon Lee
Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial
Conor Doyle, Pradeep Panda, Ellen Van de Poel, Ralf Radermacher, David M Dror
An effectiveness study of an integrated, community-based package for maternal, newborn, child and HIV care in South Africa: study protocol for a randomized controlled trial
Mark Tomlinson, Tanya Doherty, Debra Jackson, Joy E Lawn, Petrida Ijumba, Mark Colvin, Lungiswa Nkonki, Emmanuelle Daviaud, Ameena Goga, David Sanders, Carl Lombard, Lars Åke Persson, Thoko Ndaba, Gail Snetro, Mickey Chopra
Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial
Ulrike Heger, Sabine Voss, Phillip Knebel, Colette Doerr-Harim, Jens Neudecker, Christoph Schuhmacher, Eugen Faist, Markus K Diener, Meinhard Kieser, Christoph M Seiler, Markus W Büchler
The impact of clinical data on the evaluation of tibial fracture healing
Bernadette G Dijkman, Jason W Busse, Stephen D Walter, Mohit Bhandari
A trial for the use of qigong in the treatment of pre and mild essential hypertension: a study protocol for a randomized controlled trial
Ji-Eun Park, Yan Liu, Taeseob Park, Sanghoon Hong, Jung-Eun Kim, Tae-Hun Kim, Ae-Ran Kim, So-Young Jung, Hyoju Park, Sun-Mi Choi
Five years of Trials
Douglas G Altman, Iain Hrynaszkiewicz, Curt D Furberg, Jeremy M Grimshaw, Peter M Rothwell
Self Management Activation Randomised Trial for Prostatitis (SMART-P): study protocol for a randomised controlled trial
Mark Rochester, James Armitage, Mark Sanders, Paula Christmas
Reporting of participant flow diagrams in published reports of randomized trials
Sally Hopewell, Allison Hirst, Gary S Collins, Sue Mallett, Ly-Mee Yu, Douglas G Altman
Visualisation to enhance biomechanical tuning of ankle-foot orthoses (AFOs) in stroke: study protocol for a randomised controlled trial
Bruce Carse, Roy J Bowers, Barry C Meadows, Philip J Rowe
Endoscopic Saphenous harvesting with an Open CO2 System (ESOS) trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial
Antonio Campanella, Laura Bergamasco, Luigia Macri, Sofia Asioli, Roger Devotini, Serenella Scipioni, Silvana Barbaro, Pietro Rispoli, Mauro Rinaldi
A comparison of specialist rehabilitation and care assistant support with specialist rehabilitation alone and usual care for people with Parkinson's living in the community: study protocol for a randomised controlled trial
Heather Gage, Sharlene Ting, Peter Williams, Karen Bryan, Julie Kaye, Beverly Castleton, Patrick Trend, Derick Wade
A statistical framework for quantifying clinical equipoise for individual cases during randomized controlled surgical trials
Nicholas R Parsons, Yuri Kulikov, Alan Girling, Damian Griffin
A randomised controlled trial of probiotics for the prevention of spontaneous preterm delivery associated with bacterial vaginosis: preliminary results
Leticia Krauss-Silva, Maria Elizabeth L Moreira, Mariane B Alves, Alcione Braga, Karla G Camacho, Maria Rosa R Batista, Antonio Almada-Horta, Maria R Rebello, Fernando Guerra
Why we need easy access to all data from all clinical trials and how to accomplish it
Peter C Gøtzsche
A practice-based trial of blood pressure control in African Americans (TLC-Clinic): study protocol for a randomized controlled trial
Antoinette Schoenthaler, Leanne Luerassi, Jeanne A Teresi, Stephanie Silver, Jian Kong, Taiye Odedosu, Samantha Trilling, Anna Errico, Oshevire Uvwo, Kimberly Sebek, Adetutu Adekoya, Gbenga Ogedegbe
Investigating a training supporting shared decision making (IT'S SDM 2011): study protocol for a randomized controlled trial
Friedemann Geiger, Katrin Liethmann, Frauke Hoffmann, Jutta Paschedag, Jürgen Kasper
Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial
Sara Ahmed, Susan J Bartlett, Pierre Ernst, Guy Paré, Maria Kanter, Robert Perreault, Roland Grad, Laurel Taylor, Robyn Tamblyn
Computerised cognitive behavioural therapy for the treatment of depression in people with multiple sclerosis: external pilot trial
Cindy L Cooper, Daniel Hind, Glenys D Parry, Claire L Isaac, Munyaradzi Dimairo, Alicia O'Cathain, Anita Rose, Jennifer V Freeman, Leonie Martin, Eva C Kaltenthaler, Anna Thake, Basil Sharrack
The utility of Aspirin in dukes C and high risk dukes B colorectal cancer - The ASCOLT study: study protocol for a randomized controlled trial
Raghib Ali, Han-Chong Toh, Whay-Kuang Chia
Transfusion of fresh frozen plasma in non-bleeding ICU patients -TOPIC TRIAL: study protocol for a randomized controlled trial
Marcella CA Müller, Evert de Jonge, M Sesmu Arbous, Angelique ME Spoelstra -de Man, Atilla Karakus, Margreeth B Vroom, Nicole P Juffermans
Single blind randomized Phase III trial to investigate the benefit of a focal lesion ablative microboost in prostate cancer (FLAME-trial): study protocol for a randomized controlled trial
Irene M Lips, Uulke A van der Heide, Karin Haustermans, Emile NJT van Lin, Floris Pos, Stefan PG Franken, Alexis NTJ Kotte, Carla H van Gils, Marco van Vulpen
Comparisons against baseline within randomised groups are often used and can be highly misleading
J Martin Bland, Douglas G Altman
Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: Study protocol for a randomized controlled trial
Marc Cohen, Shefton Parker, David Taylor, De Villiers Smit, Michael Ben-Meir, Peter Cameron, Charlie Xue
The impact of a cancer Survivorship Care Plan on gynecological cancer patient and health care provider reported outcomes (ROGY Care): study protocol for a pragmatic cluster randomized controlled trial
Lonneke V van de Poll-Franse, Kim AH Nicolaije, Maria C Vos, Johanna MA Pijnenborg, Dorry Boll, Olga Husson, Nicole PM Ezendam, Erik A Boss, Ralph HM Hermans, Karin CM Engelhart, Joke E Haartsen, Brenda M Pijlman, Harrie WH Feijen, Helena JMM Mertens, Willem E Nolting, Johannes J van Beek, Jan A Roukema, Roy FPM Kruitwagen
Efficacy of essential oil mouthwash with and without alcohol: a 3-Day plaque accumulation model
Enrico Marchetti, Stefano Mummolo, Jonathan Di Mattia, Fabio Casalena, Salvatore Di Martino, Antonella Mattei, Giuseppe Marzo
Effects of an exercise programme for chronically ill and mobility-restricted elderly with structured support by the general practitioner's practice (HOMEfit) - study protocol of a randomised controlled trial
Timo Hinrichs, Anna Moschny, Michael Brach, Stefan Wilm, Renate Klaaßen-Mielke, Matthias Trampisch, Petra Platen
Intensified treatment with high dose Rifampicin and Levofloxacin compared to standard treatment for adult patients with Tuberculous Meningitis (TBM-IT): protocol for a randomized controlled trial
Dorothee Heemskerk, Jeremy Day, Tran Thi Hong Chau, Nguyen Huy Dung, Nguyen Thi Bich Yen, Nguyen Duc Bang, Laura Merson, Piero Olliaro, Thomas Pouplin, Maxine Caws, Marcel Wolbers, Jeremy Farrar
Assessing the efficacy of the healthy eating and lifestyle programme (HELP) compared with enhanced standard care of the obese adolescent in the community: study protocol for a randomized controlled trial
Deborah Christie, Lee Hudson, Anne Mathiot, Tim J Cole, Saffron Karlsen, Anthony Kessel, Sanjay Kinra, Steve Morris, Irwin Nazareth, Ulla Sovio, Ian CK Wong, Russell M Viner
Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited
Peter Sandercock, Richard Lindley, Joanna Wardlaw, Martin Dennis, Karen Innes, Geoff Cohen, Will Whiteley, David Perry, Vera Soosay, David Buchanan, Graham Venables, Anna Czlonkowska, Adam Kobayashi, Eivind Berge, Karsten Bruins Slot, Veronica Murray, Andre Peeters, Graeme J Hankey, Karl Matz, Michael Brainin, Stefano Ricci, Teresa A Cantisani, Gordon Gubitz, Stephen J Phillips, Arauz Antonio, Manuel Correia, Phillippe Lyrer, Ingrid Kane, Erik Lundstrom
Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial
Jorge H Ramírez, Roger M Arce, Adolfo Contreras
Cognitive activity for the treatment of older adults with mild Alzheimer's Disease (AD) - PACE AD: study protocol for a randomised controlled trial
Mandy R Vidovich, Josephine Shaw, Leon Flicker, Osvaldo P Almeida
School-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile (YPSA): study protocol for a randomized controlled trial
Ricardo Araya, Alan A Montgomery, Rosemarie Fritsch, David Gunnell, Paul Stallard, Sian Noble, Vania Martinez, Sergio Barroilhet, Paul Vohringer, Viviana Guajardo, Felix Cova, Jorge Gaete, Alejandro Gomez, Graciela Rojas
Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility
MK Campbell, VA Entwistle, BH Cuthbertson, ZC Skea, AG Sutherland, AM McDonald, JD Norrie, RV Carlson, S Bridgman
Intrathecal opioid versus ultrasound guided fascia iliaca plane block for analgesia after primary hip arthroplasty: study protocol for a randomised, blinded, noninferiority controlled trial
Rachel J Kearns, Alan JR Macfarlane, Keith J Anderson, John Kinsella
A primary-school-based study to reduce prevalence of childhood obesity in Catalunya (Spain) - EDAL-Educació en alimentació: study protocol for a randomised controlled trial
Montse Giralt, Rosa Albaladejo, Lucia Tarro, David Moriña, Victoria Arija, Rosa Solà