Study protocol  

The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial

Nathalie Davis-Lameloise, Andrea Hernan, Edward D Janus, Elizabeth Stewart, Rob Carter, Catherine M Bennett, Sharleen O’Reilly, Benjamin Philpot, Erkki Vartiainen, James A Dunbar, and on behalf of the Melbourne Diabetes Prevention Study (MDPS) research group Trials 2013, 14:31 (31 January 2013)

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Study protocol  

Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial

Katrine B Buggeskov, Jørn Wetterslev, Niels H Secher, Lars W Andersen, Thomas Jonassen, Daniel A Steinbrüchel Trials 2013, 14:30 (31 January 2013)

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Study protocol  

Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol

Daniel C Krawczyk, Carlos Marquez de la Plata, Guido F Schauer, Asha K Vas, Molly Keebler, Stephanie Tuthill, Claire Gardner, Tiffani Jantz, Weikei Yu, Sandra B Chapman Trials 2013, 14:29 (30 January 2013)

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Study protocol  

The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial

Christian Blickem, Tom Blakeman, Anne Kennedy, Peter Bower, David Reeves, Caroline Gardner, Victoria Lee, Carolyn Chew-Graham, Gerry Richardson, Helen Brooks, Shoba Dawson, Rahena Mossabir, Praksha Jariwala, Angela Swallow, Evan Kontopantelis, Hannah Gaffney, Nicola Small, Eldon Spackman, Anne Rogers Trials 2013, 14:28 (28 January 2013)

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Study protocol  

An oral preparation of Lactobacillus acidophilus for the treatment of uncomplicated acute watery diarrhoea in Vietnamese children: study protocol for a multicentre, randomised, placebo-controlled trial

Marion-Eliëtte Kolader, Ha Vinh, Pham Thi Ngoc Tuyet, Corinne Thompson, Marcel Wolbers, Laura Merson, James I Campbell, Tran Thi Ngoc Dung, Ha Manh Tuan, Nguyen Van Vinh Chau, Jeremy Farrar, H Rogier van Doorn, Stephen Baker Trials 2013, 14:27 (28 January 2013)

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Study protocol  

Evaluation of an internet-based aftercare program to improve vocational reintegration after inpatient medical rehabilitation: study protocol for a cluster-randomized controlled trial

Rüdiger Zwerenz, Katharina Gerzymisch, Jens Edinger, Martin Holme, Rudolf J Knickenberg, Sieglinde Spörl-Dönch, Ulrich Kiwus, Manfred E Beutel Trials 2013, 14:26 (25 January 2013)

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Study protocol  

Use of the ‘patient journey’ model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial

Vinaya KC Manchaiah, Dafydd Stephens, Gerhard Andersson, Jerker Rönnberg, Thomas Lunner Trials 2013, 14:25 (24 January 2013)

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Study protocol  

Rotterdam Aphasia Therapy Study (RATS) – 3: “The efficacy of intensive cognitive-linguistic therapy in the acute stage of aphasia”; design of a randomised controlled trial

Femke Nouwens, Diederik WJ Dippel, Marjolein de Jong-Hagelstein, Evy G Visch-Brink, Peter J Koudstaal, Lonneke M L de Lau, RATS-3 investigators Trials 2013, 14:24 (23 January 2013)

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Methodology  

Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome

Babak Choodari-Oskooei, Mahesh KB Parmar, Patrick Royston, Jack Bowden Trials 2013, 14:23 (23 January 2013)

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Study protocol  

Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study)

Gianfranco Parati, Stefano Omboni, Angelo Compare, Enzo Grossi, Edward Callus, Achille Venco, Maurizio Destro, Giuseppe Villa, Paolo Palatini, Enrico Agabiti Rosei, Simonetta Scalvini, Stefano Taddei, Dario Manfellotto, Stefano Favale, Carmine De Matteis, Michele Guglielmi, on behalf of the TELEBPMET Study Group Trials 2013, 14:22 (23 January 2013)

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Research  

Can a core outcome set improve the quality of systematic reviews? – a survey of the Co-ordinating Editors of Cochrane review groups

Jamie J Kirkham, Elizabeth Gargon, Mike Clarke, Paula R Williamson Trials 2013, 14:21 (22 January 2013)

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Research  

Early treatment of posterior crossbite - a randomised clinical trial

Carsten Lippold, Thomas Stamm, Ulrich Meyer, András Végh, Tatjana Moiseenko, Gholamreza Danesh Trials 2013, 14:20 (22 January 2013)

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Methodology  

Introduction to a generalized method for adaptive randomization in trials

Zoë SJ Hoare, Christopher J Whitaker, Rhiannon Whitaker Trials 2013, 14:19 (17 January 2013)

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Study protocol  

Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial

Christine M Goertz, Stacie A Salsbury, Robert D Vining, Cynthia R Long, Andrew A Andresen, Mark E Jones, Kevin J Lyons, Maria A Hondras, Lisa Z Killinger, Fredric D Wolinsky, Robert B Wallace Trials 2013, 14:18 (16 January 2013)

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Study protocol  

Optimal schedule of adjuvant chemotherapy with S-1 for stage III colon cancer: study protocol for a randomized controlled trial

Kenichi Yoshimura, Keisuke Uehara, Yuichiro Tojima, Satoru Kawai, Yasuji Mokuno, Atsuyuki Maeda, Takanori Kyokane, Satoshi Kobayashi, Yuichiro Yoshioka, Masato Nagino Trials 2013, 14:17 (15 January 2013)

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Study protocol  

Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial

Byung-Kwan Seo, Jun-Hwan Lee, Won-Suk Sung, Eun-Mo Song, Dae-Jean Jo Trials 2013, 14:16 (14 January 2013)

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Methodology  

Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting

Aileen Grant, Shaun Treweek, Tobias Dreischulte, Robbie Foy, Bruce Guthrie Trials 2013, 14:15 (12 January 2013)

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Commentary  

Commentary: Why we should report results from clinical trial pilot studies

Lawrence Friedman Trials 2013, 14:14 (11 January 2013)

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Study protocol  

Feasibility study of an optimised person-centred intervention to improve mental health and reduce antipsychotics amongst people with dementia in care homes: study protocol for a randomised controlled trial

Rhiannon Whitaker, Clive Ballard, Jane Stafford, Martin Orrell, Esme Moniz-Cook, Robert T Woods, Joanna Murray, Martin Knapp, Barbara Woodward Carlton, Jane Fossey Trials 2013, 14:13 (10 January 2013)

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Study protocol  

Clinical effect of catgut implantation at acupoints for allergic rhinitis: study protocol for a randomized controlled trial

Xinrong Li, Qinxiu Zhang, Luyun Jiang, Tao Li, Min Liu, Huanxing Liu, Xiaopei Wang, Fubing Zhang Trials 2013, 14:12 (10 January 2013)

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Study protocol  

The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

Hans Gustav Thyregod, Lars Søndergaard, Nikolaj Ihlemann, Olaf Franzen, Lars Willy Andersen, Peter Bo Hansen, Peter Skov Olsen, Henrik Nissen, Per Winkel, Christian Gluud, Daniel Andreas Steinbrüchel Trials 2013, 14:11 (9 January 2013)

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Study protocol  

Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D): study protocol for a randomised controlled trial

Matthew P Leighton, Ching Lam, Samir Mehta, Robin C Spiller Trials 2013, 14:10 (9 January 2013)

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Study protocol  

Improving the application of a practice guideline for the assessment and treatment of suicidal behavior by training the full staff of psychiatric departments via an e-learning supported Train-the-Trainer program: study protocol for a randomized controlled trial

Derek P de Beurs, Marieke H de Groot, Jos de Keijser, Bastiaan Verwey, Jan Mokkenstorm, Jos WR Twisk, Erik van Duijn, Albert M van Hemert, Lia Verlinde, Jan Spijker, Bert van Luijn, Jan Vink, Ad JFM Kerkhof Trials 2013, 14:9 (9 January 2013)

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Study protocol  

Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial

Hadar Lev-Tov, Chin-Shang Li, Sara Dahle, Roslyn Rivkah Isseroff Trials 2013, 14:8 (9 January 2013)

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Study protocol  

Practical health co-operation - the impact of a referral template on quality of care and health care co-operation: study protocol for a cluster randomized controlled trial

Henrik Wåhlberg, Per Christian Valle, Siri Malm, Ann Ragnhild Broderstad Trials 2013, 14:7 (7 January 2013)

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Study protocol  

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

Christine M Freitag, Hannah Cholemkery, Leyla Elsuni, Anne K Kroeger, Stephan Bender, Cornelia Ursula Kunz, Meinhard Kieser Trials 2013, 14:6 (7 January 2013)

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Study protocol  

The NAILED stroke risk factor trial (Nurse based Age independent Intervention to Limit Evolution of Disease after stroke): study protocol for a randomized controlled trial

Thomas Mooe, Lisa Bergström, Anna-Lotta Irewall, Joachim Ögren Trials 2013, 14:5 (5 January 2013)

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Study protocol  

The effectiveness and cost-effectiveness of telephone triage of patients requesting same day consultations in general practice: study protocol for a cluster randomised controlled trial comparing nurse-led and GP-led management systems (ESTEEM)

John L Campbell, Nicky Britten, Colin Green, Tim A Holt, Valerie Lattimer, Suzanne H Richards, David A Richards, Chris Salisbury, Rod S Taylor, Emily Fletcher Trials 2013, 14:4 (4 January 2013)

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Study protocol  

Evaluation of the efficacy of memantine in the treatment of fibromyalgia: study protocol for a doubled-blind randomized controlled trial with six-month follow-up

Bárbara Olivan-Blázquez, Marta Puebla, Bárbara Masluk, Mari-Cruz Pérez-Yus, Raquel Arcega, Eva Andrés, Yolanda López-del-Hoyo, Rosa Magallon, Miquel Roca, Javier Garcia-Campayo Trials 2013, 14:3 (3 January 2013)

Abstract | Full text | PDF | PubMed

Study protocol  

Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial

Yuan-Fang Chen, Jian-Hua Liu, Neng-Gui Xu, Zhao-Hui Liang, Zhen-Hua Xu, Shu-Jun Xu, Wen-Bin Fu Trials 2013, 14:2 (3 January 2013)

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Research  

Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis

Andrew D McRae, Carol Bennett, Judith Belle Brown, Charles Weijer, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Allan Donner, Martin Eccles, Jeremy Grimshaw, Merrick Zwarenstein, Monica Taljaard Trials 2013, 14:1 (3 January 2013)

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