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Study protocol   Open Access

Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial

Guillem Feixas, Arturo Bados, Eugeni García-Grau, Adrián Montesano, Gloria Dada, Victoria Compañ, Mari Aguilera, Marta Salla, Joan Miquel Soldevilla, Adriana Trujillo, Clara Paz, Lluís Botella, Sergi Corbella, Luis Ángel Saúl-Gutiérrez, José Cañete, Miquel Gasol, Montserrat Ibarra, Leticia Medeiros-Ferreira, José Soriano, Eugénia Ribeiro, Franz Caspar, David Winter Trials 2013, 14:144 (17 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Ultra-early tranexamic acid after subarachnoid hemorrhage (ULTRA): study protocol for a randomized controlled trial

Menno R Germans, René Post, Bert A Coert, Gabriël JE Rinkel, W Peter Vandertop, Dagmar Verbaan Trials 2013, 14:143 (16 May 2013)

Abstract | Provisional PDF

Research   Open Access

Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya

George Okello, Caroline Jones, Maureen Bonareri, Sarah N Ndegwa, Carlos Mcharo, Juddy Kengo, Kevin Kinyua, Margaret M Dubeck, Katherine E Halliday, Matthew CH Jukes, Sassy Molyneux, Simon J Brooker Trials 2013, 14:142 (16 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Efficacy and safety of active negative pressure peritoneal therapy for reducing the systemic inflammatory response after damage control laparotomy (the Intra-peritoneal Vacuum Trial): study protocol for a randomized controlled trial

Derek J Roberts, Craig N Jenne, Chad G Ball, Corina Tiruta, Caroline Léger, Zhengwen Xiao, Peter D Faris, Paul B McBeth, Christopher J Doig, Christine R Skinner, Stacy G Ruddell, Paul Kubes, Andrew W Kirkpatrick Trials 2013, 14:141 (16 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Acceptance and Commitment Therapy for anxious children and adolescents: study protocol for a randomized controlled trial

Jessica Swain, Karen Hancock, Angela Dixon, Siew Koo, Jenny Bowman Trials 2013, 14:140 (15 May 2013)

Abstract | Provisional PDF | PubMed

Study protocol   Open Access

Model-driven diabetes care: study protocol for a randomized controlled trial

Stein Olav Skrøvseth, Eirik Årsand, Fred Godtliebsen, Ragnar M Joakimsen Trials 2013, 14:139 (14 May 2013)

Abstract | Full text | PDF | PubMed

Study protocol   Open Access

Clinical assessment of complementary treatment with Qishen Yiqi dripping pills on ischemic heart failure: study protocol for a randomized, double-blind, multicenter, placebo-controlled trial (CACT-IHF)

Shuai Wang, Ya Zhu Hou, Zhi Qiang Zhao, Xian Liang Wang, Bin Li, Shan Bin Soh, Jing Yuan Mao Trials 2013, 14:138 (14 May 2013)

Abstract | Provisional PDF | PubMed

Study protocol   Open Access

Treatment of traumatized refugees with Sertraline versus Venlafaxine in combination with psychotherapy -- study protocol for a randomized clinical trial

Charlotte Sonne, Jessica Carlsson, Ask Elklit, Erik Lykke Mortensen, Morten Ekstrøm Trials 2013, 14:137 (11 May 2013)

Abstract | Provisional PDF | PubMed

Update   Open Access

Update on the collaborative interventions for circulation and depression (COINCIDE) trial: changes to planned methodology of a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease

Peter A Coventry, Karina Lovell, Chris Dickens, Peter Bower, Carolyn Chew-Graham, Andrea Cherrington, Charlotte Garrett, Chris J Gibbons, Clare Baguley, Kate Roughley, Isabel Adeyemi, Chris Keyworth, Waquas Waheed, Mark Hann, Linda Davies, Farheen Jeeva, Chris Roberts, Sarah Knowles, Linda Gask Trials 2013, 14:136 (11 May 2013)

Abstract | Provisional PDF | PubMed

Study protocol   Open Access

Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial

Catherine Malboeuf-Hurtubise, Marie Achille, Serge Sultan, Majorie Vadnais Trials 2013, 14:135 (10 May 2013)

Abstract | Full text | PDF | PubMed

Study protocol   Open Access

Effects of light-emitting diodes on muscle fatigue and exercise tolerance in patients with COPD: study protocol for a randomized controlled trial

Eduardo Foschini Miranda, Ernesto Cesar Pinto Leal-Junior, Paulo Henrique Marchetti, Simone Dal Corso Trials 2013, 14:134 (10 May 2013)

Abstract | Full text | PDF | PubMed

Research   Open Access

Drug-eluting stents or coronary artery bypass grafting for unprotected left main coronary artery disease: a meta-analysis of four randomized trials and seventeen observational studies

Qing Li, Zhi Zhang, Rui-Xing Yin Trials 2013, 14:133 (8 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Community resource centres to improve the health of women and children in Mumbai slums: study protocol for a cluster randomized controlled trial

Neena Shah More, Sushmita Das, Ujwala Bapat, Mahesh Rajguru, Glyn Alcock, Wasundhara Joshi, Shanti Pantvaidya, David Osrin Trials 2013, 14:132 (8 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Use of biological mesh versus standard wound care in infected incisional ventral hernias, the SIMBIOSE study: a study protocol for a randomized multicenter controlled trial

Christophe Mariette, Nicolas Briez, Fanette Denies, Benoît Dervaux, Alain Duhamel, Marie Guilbert, Emilie Bruyère, William B Robb, Guillaume Piessen, on behalf of FRENCH Trials 2013, 14:131 (7 May 2013)

Abstract | Full text | PDF

Study protocol   Open Access

Randomized controlled pilot study of a SystemCHANGETM weight management intervention in stroke survivors: rationale and protocol

Matthew Plow, Shirley M Moore, John P Kirwan, Fredrick Frost, Irene Katzan, Sue Jaeger, Jay Alberts Trials 2013, 14:130 (7 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Comparing the effects of individualized, standard, sham and no acupuncture in the treatment of knee osteoarthritis: a multicenter randomized controlled trial

Eun-Jung Kim, Chi-Yeon Lim, Eun-Yong Lee, Seung-Deok Lee, Kap-Sung Kim Trials 2013, 14:129 (7 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial

Annie LeBlanc, Amy E Bodde, Megan E Branda, Kathleen J Yost, Jeff Herrin, Mark D Williams, Nilay D Shah, Holly Houten, Kari L Ruud, Laurie J Pencille, Victor M Montori Trials 2013, 14:127 (7 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial

Catriona M Steele, Mark A Bayley, Melanie Péladeau-Pigeon, Shauna L Stokely Trials 2013, 14:126 (7 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Medication adherence and tolerability of Alzheimer’s disease medications: study protocol for a randomized controlled trial

Noll L Campbell, Paul Dexter, Anthony J Perkins, Sujuan Gao, Lang Li, Todd C Skaar, Amie Frame, Hugh C Hendrie, Chris M Callahan, Malaz A Boustani Trials 2013, 14:125 (4 May 2013)

Abstract | Full text | PDF

Study protocol   Open Access

A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial

Christina Günter, Augustinus Bader, Ulf Dornseifer, Silvia Egert, Sebastian Dunda, Gerrit Grieb, Thomas Wolter, Norbert Pallua, Tobias von Wild, Frank Siemers, Peter Mailänder, Oliver Thamm, Carsten Ernert, Michael Steen, Reiner Sievers, Bert Reichert, Afshin Rahmanian-Schwarz, Hans Schaller, Bernd Hartmann, Max Otte, Victoria Kehl, Christian Ohmann, Wolfgang Jelkmann, Hans-Günther Machens Trials 2013, 14:124 (3 May 2013)

Abstract | Full text | PDF

Research   Open Access

Methods of creatine kinase-MB analysis to predict mortality in patients with myocardial infarction treated with reperfusion therapy

Renato D Lopes, Yuliya Lokhnygina, Victor Hasselblad, Kristin L Newby, Eric Yow, Christopher B Granger, Paul W Armstrong, Judith S Hochman, James S Mills, Witold Ruzyllo, Kenneth W Mahaffey Trials 2013, 14:123 (2 May 2013)

Abstract | Provisional PDF

Study protocol   Open Access

Action 3:30: protocol for a randomized feasibility trial of a teaching assistant led extracurricular physical activity intervention

Russell Jago, Mark J Edwards, Ashley R Cooper, Kenneth R Fox, Jane Powell, Simon J Sebire, Melissa Spears, Janice L Thompson, Alan A Montgomery Trials 2013, 14:122 (2 May 2013)

Abstract | Full text | PDF

Study protocol   Open Access

An evaluation of Croí MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial

Jennifer J Infanti, Fidelma P Dunne, Angela O’Dea, Paddy Gillespie, Irene Gibson, Liam G Glynn, Eoin Noctor, John Newell, Brian E McGuire Trials 2013, 14:121 (2 May 2013)

Abstract | Full text | PDF

Study protocol   Open Access

A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial

Simon Hyttel-Sorensen, Topun Austin, Frank van Bel, Manon Benders, Olivier Claris, Eugene Dempsey, Monica Fumagalli, Gorm Greisen, Berit Grevstad, Cornelia Hagmann, Lena Hellström-Westas, Petra Lemmers, Jane Lindschou, Gunnar Naulaers, Wim van Oeveren, Adelina Pellicer, Gerhard Pichler, Claudia Roll, Maria Skoog, Per Winkel, Martin Wolf, Christian Gluud Trials 2013, 14:120 (1 May 2013)

Abstract | Full text | PDF

Study protocol   Open Access

Selenium supplementation for patients with Graves’ hyperthyroidism (the GRASS trial): study protocol for a randomized controlled trial

Torquil Watt, Per Cramon, Jakob Bjorner, Steen Bonnema, Ulla Feldt-Rasmussen, Christian Gluud, Jeppe Gram, Jane Hansen, Laszlo Hegedüs, Nils Knudsen, Pernille Bach-Mortensen, Runa Nolsøe, Birte Nygaard, Flemming Pociot, Maria Skoog, Per Winkel, Åse Rasmussen Trials 2013, 14:119 (30 April 2013)

Abstract | Full text | PDF

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