Skip to main content
main-content

Zeitschrift

Trials

Trials 1/2016

Ausgabe 1/2016

Inhaltsverzeichnis ( 608 Artikel )

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Guided, internet-based, rumination-focused cognitive behavioural therapy (i-RFCBT) versus a no-intervention control to prevent depression in high-ruminating young adults, along with an adjunct assessment of the feasibility of unguided i-RFCBT, in the REducing Stress and Preventing Depression trial (RESPOND): study protocol for a phase III randomised controlled trial

Lorna Cook, Edward Watkins

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Systemic therapy for vulval Erosive Lichen Planus (the ‘hELP’ trial): study protocol for a randomised controlled trial

Rosalind C. Simpson, Ruth Murphy, Daniel J. Bratton, Matthew R. Sydes, Sally Wilkes, Helen Nankervis, Shelley Dowey, Kim S. Thomas

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The efficacy and safety of the Shaoyao Shujin tablet for knee osteoarthritis: study protocol for a randomized controlled trial

Xue-Wei Cao, Da Guo, Jin-Wen Liu, Wei Niu, Jun Liu, Jian-Ke Pan, Hui Xie, Wen-Wei Ouyang, Ding-Kun Lin

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial

Cesare Cavalera, Francesco Pagnini, Marco Rovaris, Laura Mendozzi, Luigi Pugnetti, Massimo Garegnani, Enrico Molinari

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Early biliary decompression versus conservative treatment in acute biliary pancreatitis (APEC trial): study protocol for a randomized controlled trial

Nicolien J. Schepers, Olaf J. Bakker, Marc G. H. Besselink, Thomas L. Bollen, Marcel G. W. Dijkgraaf, Casper H. J. van Eijck, Paul Fockens, Erwin J. M. van Geenen, Janneke van Grinsven, Nora D. L. Hallensleben, Bettina E. Hansen, Hjalmar C. van Santvoort, Robin Timmer, Marie-Paule G. F. Anten, Clemens J. M. Bolwerk, Foke van Delft, Hendrik M. van Dullemen, G. Willemien Erkelens, Jeanin E. van Hooft, Robert Laheij, René W. M. van der Hulst, Jeroen M. Jansen, Frank J. G. M. Kubben, Sjoerd D. Kuiken, Lars E. Perk, Rogier J. J. de Ridder, Marno C. M. Rijk, Tessa E. H. Römkens, Erik J. Schoon, Matthijs P. Schwartz, B. W. Marcel Spanier, Adriaan C. I. T. L. Tan, Willem J. Thijs, Niels G. Venneman, Frank P. Vleggaar, Wim van de Vrie, Ben J. Witteman, Hein G. Gooszen, Marco J. Bruno, for the Dutch Pancreatitis Study Group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Statistical design and analysis plan for an impact evaluation of an HIV treatment and prevention intervention for female sex workers in Zimbabwe: a study protocol for a cluster randomised controlled trial

James R. Hargreaves, Elizabeth Fearon, Calum Davey, Andrew Phillips, Valentina Cambiano, Frances M. Cowan

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum To: Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial

Meredith A. Achey, Christopher A. Beck, Denise B. Beran, Cynthia M. Boyd, Peter N. Schmidt, Allison W. Willis, Sara S. Riggare, Richard B. Simone, Kevin M. Biglan, E. Ray Dorsey

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of an individualized program of muscular strength and endurance with aerobic training for improving germ cell cancer-related fatigue in men undergoing chemotherapy: EFICATEST study protocol for a randomized controlled trial

Antonio Ignacio Cuesta-Vargas, Francisco Carabantes, Zaira Caracuel, Inmaculada Conejo, Emilio Alba

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Assessment of the effeCt of lIfestyle iNtervention plus water-soluble ciNnAMon extract On loweriNg blood glucose in pre-diabetics, a randomized, double-blind, multicenter, placebo controlled trial: study protocol for a randomized controlled trial

Paul Crawford, Chuong Thai, Joshua Obholz, Jeffrey Schievenin, Mark True, Sachin A. Shah, John Hallgren, Jill Clark, Danny Sharon

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy study of olmesartan medoxomil on coronary atherosclerosis progression and epicardial adipose tissue volume reduction in patients with coronary atherosclerosis detected by coronary computed tomography angiography: study protocol for a randomized controlled trial

Ying Zhou, Feng Tian, Jing Wang, Jun-Jie Yang, Tao Zhang, Jing Jing, Yun-Dai Chen

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial

Matthew A. Popplewell, Huw Davies, Hugh Jarrett, Gareth Bate, Margaret Grant, Smitaa Patel, Samir Mehta, Lazaros Andronis, Tracy Roberts, Jon Deeks, Andrew Bradbury, on Behalf of the BASIL-2 Trial Investigators

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The ethics of future trials: qualitative analysis of physicians’ decision making

Fiona Webster, Charles Weijer, Laura Todd, Jeremy M. Grimshaw, Andrea P. Marshall, Deborah Cook, Graeme MacLennan, Brian H. Cuthbertson, Jill J. Francis, for the SuDDICU international group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Family-led rehabilitation after stroke in India: the ATTEND trial, study protocol for a randomized controlled trial

Mohammed Alim, Richard Lindley, Cynthia Felix, Dorcas Beulah Chandramathy Gandhi, Shweta Jain Verma, Deepak Kumar Tugnawat, Anuradha Syrigapu, Craig Stuart Anderson, Ramaprabhu Krishnappa Ramamurthy, Peter Langhorne, Gudlavalleti Venkata Satyanarayana Murthy, Bindiganavale Ramaswamy Shamanna, Maree Lisa Hackett, Pallab Kumar Maulik, Lisa Anne Harvey, Stephen Jan, Hueiming Liu, Marion Walker, Anne Forster, Jeyaraj Durai Pandian

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Sequential learning of psychomotor and visuospatial skills for laparoscopic suturing and knot tying – study protocol for a randomized controlled trial “The shoebox study”

Jonathan D. Hendrie, Felix Nickel, Thomas Bruckner, Karl-Friedrich Kowalewski, Carly R. Garrow, Maisha Mantel, Philipp Romero, Beat P. Müller-Stich

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Temperature-controlled laminar airflow in severe asthma for exacerbation reduction (The LASER Trial): study protocol for a randomised controlled trial

Will Storrar, Carole Fogg, Tom Brown, Paddy Dennison, Ly-Mee Yu, Ann Dewey, Ramon Luengo-Fernandez, Tara Dean, Najib Rahman, Adel Mansur, Peter H. Howarth, Peter Bradding, Anoop J. Chauhan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparative effectiveness of antihypertensive treatment for older children with primary hypertension: study protocol for a series of n-of-1 randomized trials

Joyce P. Samuel, Joshua A. Samuels, Lauren E. Brooks, Cynthia S. Bell, Claudia Pedroza, Donald A. Molony, Jon E. Tyson

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Patients’ willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey

Sing Yu Moorcraft, Cheryl Marriott, Clare Peckitt, David Cunningham, Ian Chau, Naureen Starling, David Watkins, Sheela Rao

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Cardiovascular Health in Anxiety or Mood Problems Study (CHAMPS): study protocol for a randomized controlled trial

Phillip J. Tully, Deborah A. Turnbull, John D. Horowitz, John F. Beltrame, Terina Selkow, Bernhard T. Baune, Elizabeth Markwick, Shannon Sauer-Zavala, Harald Baumeister, Suzanne Cosh, Gary A. Wittert

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A European multi-language initiative to make the general population aware of independent clinical research: the European Communication on Research Awareness Need project

Paola Mosconi, Gerd Antes, Giorgio Barbareschi, Amanda Burls, Jacques Demotes-Mainard, Iain Chalmers, Cinzia Colombo, Silvio Garattini, Christian Gluud, Gill Gyte, Catherine Mcllwain, Matt Penfold, Nils Post, Roberto Satolli, Maria Rosa Valetto, Brian West, Stephanie Wolff

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Combining long-lasting insecticidal nets and indoor residual spraying for malaria prevention in Ethiopia: study protocol for a cluster randomized controlled trial

Wakgari Deressa, Eskindir Loha, Meshesha Balkew, Alemayehu Hailu, Taye Gari, Oljira Kenea, Hans J. Overgaard, Teshome Gebremichael, Bjarne Robberstad, Bernt Lindtjørn

01.12.2016 | Review | Ausgabe 1/2016 Open Access

Expanded Access Programme: looking for a common definition

Antonella Iudicello, Lucia Alberghini, Giulia Benini, Paola Mosconi

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Is family integrated care in neonatal intensive care units feasible and good for preterm infants in China: study protocol for a cluster randomized controlled trial

Mingyan Hei, Xiangyu Gao, Xirong Gao, Shaohan Nong, Aimin Zhang, Qianshen Zhang, Shoo K. Lee

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Process evaluation of a knowledge translation intervention using facilitation of local stakeholder groups to improve neonatal survival in the Quang Ninh province, Vietnam

Leif Eriksson, Tran Q. Huy, Duong M. Duc, Katarina Ekholm Selling, Dinh P. Hoa, Nguyen T. Thuy, Nguyen T. Nga, Lars-Åke Persson, Lars Wallin

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients (The EMPOWER Trial): study protocol for a randomised controlled trial

Lisa Loughney, Malcolm A. West, Graham J. Kemp, Harry B. Rossiter, Shaunna M. Burke, Trevor Cox, Christopher P. Barben, Michael G. Mythen, Peter Calverley, Daniel H. Palmer, Michael P. W. Grocott, Sandy Jack

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of virtual reality exposure therapy on social participation in people with a psychotic disorder (VRETp): study protocol for a randomized controlled trial

Roos Pot-Kolder, Wim Veling, Chris Geraets, Mark van der Gaag

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Culturally adaptive storytelling method to improve hypertension control in Vietnam - “We talk about our hypertension”: study protocol for a feasibility cluster-randomized controlled trial

Jeroan J. Allison, Hoa L. Nguyen, Duc A. Ha, Germán Chiriboga, Ha N. Ly, Hanh T. Tran, Ngoc T. Phan, Nguyen C. Vu, Minjin Kim, Robert J. Goldberg

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Guidelines for reporting embedded recruitment trials

Vichithranie W. Madurasinghe, Sandra Eldridge on behalf of MRC START Group and Gordon Forbes on behalf of the START Expert Consensus Group

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Simple steps to develop trial follow-up procedures

Ona McCarthy, Rebecca S. French, Ian Roberts, Caroline Free

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Dipeptidyl peptidase-4 inhibition and narrow-band ultraviolet-B light in psoriasis (DINUP): study protocol for a randomised controlled trial

Maeve Lynch, Tomás B. Ahern, Irene Timoney, Cheryl Sweeney, Genevieve Kelly, Rosalind Hughes, Anne-Marie Tobin, Donal O’Shea, Brian Kirby

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

PANasta Trial; Cattell Warren versus Blumgart techniques of panreatico-jejunostomy following pancreato-duodenectomy: Study protocol for a randomized controlled trial

Christopher M. Halloran, Kellie Platt, Abbie Gerard, Fotis Polydoros, Derek A. O’Reilly, Dhanwant Gomez, Andrew Smith, John P. Neoptolemos, Zahir Soonwalla, Mark Taylor, Jane M. Blazeby, Paula Ghaneh

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Characterisation of trials where marketing purposes have been influential in study design: a descriptive study

Virginia Barbour, Druin Burch, Fiona Godlee, Carl Heneghan, Richard Lehman, Rafael Perera, Joseph S. Ross, Sara Schroter

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory

Karin E. Johnson, Gila Neta, Laura M. Dember, Gloria D. Coronado, Jerry Suls, David A. Chambers, Sean Rundell, David H. Smith, Benmei Liu, Stephen Taplin, Catherine M. Stoney, Margaret M. Farrell, Russell E. Glasgow

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of a behavioral incentive scheme linked to goal achievement: study protocol for a randomized controlled trial

Julie Redfern, Gemma Enright, Simon Raadsma, Margaret Allman-Farinelli, Christine Innes-Hughes, Santosh Khanal, Sarah Lukeis, Chris Rissel, Alex Gyani

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The role of primary tumor resection in colorectal cancer patients with asymptomatic, synchronous unresectable metastasis: Study protocol for a randomized controlled trial

Chang Woo Kim, Jeong-Heum Baek, Gyu-Seog Choi, Chang Sik Yu, Sung Bum Kang, Won Cheol Park, Bong Hwa Lee, Hyeong Rok Kim, Jae Hwan Oh, Jae-Hwang Kim, Seung-Yong Jeong, Jung Bae Ahn, Seung Hyuk Baik

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Why do patients decline surgical trials? Findings from a qualitative interview study embedded in the Cancer Research UK BOLERO trial (Bladder cancer: Open versus Lapararoscopic or RObotic cystectomy)

Emily Harrop, John Kelly, Gareth Griffiths, Angela Casbard, Annmarie Nelson, Published on behalf of the BOLERO Trial Management Group (TMG)

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Spectacle wearing in children randomised to ready-made or custom spectacles, and potential cost savings to programmes: study protocol for a randomised controlled trial

Priya Morjaria, Kaushik Murali, Jennifer Evans, Clare Gilbert

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Evaluation of alternative school feeding models on nutrition, education, agriculture and other social outcomes in Ghana: rationale, randomised design and baseline data

Aulo Gelli, Edoardo Masset, Gloria Folson, Anthoni Kusi, Daniel K. Arhinful, Felix Asante, Irene Ayi, Kwabena M. Bosompem, Kristie Watkins, Lutuf Abdul-Rahman, Rosanna Agble, Getrude Ananse-Baden, Daniel Mumuni, Elisabetta Aurino, Meena Fernandes, Lesley Drake

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Are glucose levels, glucose variability and autonomic control influenced by inspiratory muscle exercise in patients with type 2 diabetes? Study protocol for a randomized controlled trial

ASO Schein, APS Correa, Karina Rabello Casali, Beatriz D. Schaan

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: The Multi Centre Canadian Acellular Dermal Matrix Trial (MCCAT): study protocol for a randomized controlled trial in implant-based breast reconstruction

Toni Zhong, Claire Temple-Oberle, Stefan O. P. Hofer, Brett Beber, John Semple, Mitchell Brown, Sheina Macadam, Peter Lennox, Tony Panzarella, Colleen McCarthy, Nancy Baxter, For the MCCAT Study Group

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘The Memory Aid study: protocol for a randomized controlled clinical trial evaluating the effect of computer-based working memory training in elderly patients with mild cognitive impairment (MCI)’

Marianne M. Flak, Susanne S. Hernes, Linda Chang, Thomas Ernst, Vanessa Douet, Jon Skranes, Gro C. C. Løhaugen

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Effect of a high-dose target-controlled naloxone infusion on pain and hyperalgesia in patients following groin hernia repair: study protocol for a randomized controlled trial’

Manuel Pedro Pereira, Mads Utke Werner, Joergen Berg Dahl

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial’

Rebecca Sudore, Gem M. Le, Ryan McMahan, Mariko Feuz, Mary Katen, Deborah E. Barnes

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial’

Dylan R. Morris, Margaret A. Cunningham, Anna A. Ahimastos, Bronwyn A. Kingwell, Elise Pappas, Michael Bourke, Christopher M. Reid, Theo Stijnen, Ronald L. Dalman, Oliver O. Aalami, Jan H. Lindeman, Paul E. Norman, Philip J. Walker, Robert Fitridge, Bernie Bourke, Anthony E. Dear, Jenna Pinchbeck, Rene Jaeggi, Jonathan Golledge

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of the pattern of glucocorticoid replacement on neural processing, emotional reactivity and well-being in healthy male individuals: study protocol for a randomised controlled trial

Konstantinos Kalafatakis, Georgina M. Russell, Catherine J. Harmer, Marcus R. Munafo, Nicky Marchant, Aileen Wilson, Jonathan C. W. Brooks, Ngoc J. Thai, Stuart G. Ferguson, Kirsty Stevenson, Claire Durant, Kristin Schmidt, Stafford L. Lightman

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of postoperative administration of celecoxib on pain management in patients after total knee arthroplasty: study protocol for an open-label randomized controlled trial

Takeo Mammoto, Keiko Fujie, Naotaka Mamizuka, Noriko Taguchi, Atsushi Hirano, Masashi Yamazaki, Satoshi Ueno, Enbo Ma, Koichi Hashimoto

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Prospective analysis of UGT1A1 promoter polymorphism for irinotecan dose escalation in metastatic colorectal cancer patients treated with bevacizumab plus FOLFIRI as the first-line setting: study protocol for a randomized controlled trial

Yung-Sung Yeh, Hsiang-Lin Tsai, Ching-Wen Huang, Jui-Ho Wang, Yi-Wen Lin, Hsiu-Chih Tang, Yung-Chuan Sung, Chang-Chieh Wu, Chien-Yu Lu, Jaw-Yuan Wang

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Randomized, controlled, two-arm, interventional, multicenter study on risk-adapted damage control orthopedic surgery of femur shaft fractures in multiple-trauma patients

Dieter Rixen, Eva Steinhausen, Stefan Sauerland, Rolf Lefering, Marc G. Maegele, Bertil Bouillon, Guido Grass, Edmund A. M. Neugebauer, and members of the Damage Control Study Group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Chitosan nerve tube for primary repair of traumatic sensory nerve lesions of the hand without a gap: study protocol for a randomized controlled trial

Florian Neubrech, Sina Heider, Leila Harhaus, Berthold Bickert, Ulrich Kneser, Thomas Kremer

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Working memory and processing speed training in schizophrenia: study protocol for a randomized controlled trial

Briana D. Cassetta, Vina M. Goghari

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Non-invasive programmed stimulation to identify high-risk patients with implanted cardioverter defibrillator (the NIPS-ICD study): study protocol for a randomized controlled trial

Piotr Futyma, Marian Futyma, Piotr Kułakowski

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Improving delivery of secondary prophylaxis for rheumatic heart disease in remote Indigenous communities: study protocol for a stepped-wedge randomised trial

Anna P. Ralph, Clancy Read, Vanessa Johnston, Jessica L. de Dassel, Kerstin Bycroft, Alice Mitchell, Ross S. Bailie, Graeme P. Maguire, Keith Edwards, Bart J. Currie, Adrienne Kirby, Jonathan R. Carapetis

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Translating knowledge for action against stroke – using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke)

Ayeesha Kamran Kamal, Adeel Khoja, Bushra Usmani, Abdul Muqeet, Fabiha Zaidi, Masood Ahmed, Saadia Shakeel, Nabila Soomro, Ambreen Gowani, Nargis Asad, Asma Ahmed, Saleem Sayani, Iqbal Azam, Sarah Saleem

01.12.2016 | Update | Ausgabe 1/2016 Open Access

PRECISE — pregabalin in addition to usual care: statistical analysis plan

Stephanie Mathieson, Laurent Billot, Christopher G. Maher, Andrew J. McLachlan, Jane Latimer, Bart W. Koes, Mark J. Hancock, Ian Harris, Richard O. Day, Justin Pik, Stephen Jan, Chung-Wei Christine Lin

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Home-administered pre-surgical psychological intervention for knee osteoarthritis (HAPPiKNEES): study protocol for a randomised controlled trial

Roshan das Nair, Pippa Anderson, Simon Clarke, Paul Leighton, Nadina B. Lincoln, Jacqueline R. Mhizha-Murira, Brigitte E. Scammell, David A. Walsh

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The Healthy Heart-Mind trial: melatonin for prevention of delirium following cardiac surgery: study protocol for a randomized controlled trial

Andrew H. Ford, Leon Flicker, Jurgen Passage, Bradley Wibrow, Matthew Anstey, Mark Edwards, Osvaldo P. Almeida

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Stroke Treatment Associated with Rehabilitation Therapy and Transcranial DC Stimulation (START-tDCS): a study protocol for a randomized controlled trial

Suellen M. Andrade, Natanael A. Santos, Bernardino Fernández-Calvo, Paulo S. Boggio, Eliane A. Oliveira, José J. Ferreira, Amanda Sobreira, Felipe Morgan, Germana Medeiros, Gyovanna S. Cavalcanti, Ingrid D. Gadelha, Jader Duarte, Joercia Marrocos, Michele A. Silva, Thatiana Rufino, Sanmy R. Nóbrega

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Polypharmacy in chronic diseases–Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial

Andreas Sönnichsen, Ulrike S. Trampisch, Anja Rieckert, Giuliano Piccoliori, Anna Vögele, Maria Flamm, Tim Johansson, Aneez Esmail, David Reeves, Christin Löffler, Jennifer Höck, Renate Klaassen-Mielke, Hans Joachim Trampisch, Ilkka Kunnamo

01.12.2016 | Review | Ausgabe 1/2016 Open Access

Perspectives on the design and methodology of periconceptional nutrient supplementation trials

Bernard J. Brabin, Sabine Gies, Stephen Owens, Yves Claeys, Umberto D’Alessandro, Halidou Tinto, Loretta Brabin

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Assessing the effectiveness of enhanced psychological care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): study protocol for a pilot cluster randomised controlled trial

Suzanne H. Richards, Chris Dickens, Rob Anderson, David A. Richards, Rod S. Taylor, Obioha C. Ukoumunne, David Kessler, Katrina Turner, Willem Kuyken, Manish Gandhi, Luke Knight, Andrew Gibson, Antoinette Davey, Fiona Warren, Rachel Winder, Christine Wright, John Campbell

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial

Alexander Miloff, Philip Lindner, William Hamilton, Lena Reuterskiöld, Gerhard Andersson, Per Carlbring

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Stereotactic versus conventional radiotherapy for pain reduction and quality of life in spinal metastases: study protocol for a randomized controlled trial

Pètra Braam, Philippe Lambin, Johan Bussink

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Neural correlates of working memory training in HIV patients: study protocol for a randomized controlled trial

L Chang, GC Løhaugen, V Douet, EN Miller, J Skranes, T Ernst

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial

Denise A. Yardley, Adam Brufsky, Robert E. Coleman, Pierfranco F. Conte, Javier Cortes, Stefan Glück, Jean-Mark A. Nabholtz, Joyce O’Shaughnessy, Robert M. Beck, Amy Ko, Markus F. Renschler, Debora Barton, Nadia Harbeck

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial

Chinwe Onu, Linnet Ongeri, Elizabeth Bukusi, Craig R. Cohen, Thomas C. Neylan, Patrick Oyaro, Grace Rota, Faith Otewa, Kevin L. Delucchi, Susan M. Meffert

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Community occupational therapy for people with dementia and family carers (COTiD-UK) versus treatment as usual (Valuing Active Life in Dementia [VALID] programme): study protocol for a randomised controlled trial

Jennifer Wenborn, Sinéad Hynes, Esme Moniz-Cook, Gail Mountain, Fiona Poland, Michael King, Rumana Omar, Steven Morris, Myrra Vernooij-Dassen, David Challis, Susan Michie, Ian Russell, Catherine Sackley, Maud Graff, Aidan O’Keeffe, Nadia Crellin, Martin Orrell

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Mirtazapine added to selective serotonin reuptake inhibitors for treatment-resistant depression in primary care (MIR trial): study protocol for a randomised controlled trial

Debbie Tallon, Nicola Wiles, John Campbell, Carolyn Chew-Graham, Chris Dickens, Una Macleod, Tim J. Peters, Glyn Lewis, Ian M. Anderson, Simon Gilbody, William Hollingworth, Simon Davies, David Kessler

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

National Safety Associates nutritional supplementation trial of fruit and vegetable extracts and vascular function (NNTV): study protocol for a randomised controlled trial

Marietta Sayegh, Melina Tsiountsioura, Polly Page, Dan Del Rio, Sumantra Ray

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial

Sheri A. Lippman, Starley B. Shade, Jeri Sumitani, Julia DeKadt, Jennifer M. Gilvydis, Mary Jane Ratlhagana, Jessica Grignon, John Tumbo, Hailey Gilmore, Emily Agnew, Parya Saberi, Scott Barnhart, Wayne T. Steward

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth – the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial

Fausto Medeiros Mendes, Laura Regina Antunes Pontes, Thais Gimenez, Juan Sebastian Lara, Lucila Basto de Camargo, Edgard Michel-Crosato, Claudio Mendes Pannuti, Daniela Prócida Raggio, Mariana Minatel Braga, Tatiane Fernandes Novaes, CARDEC collaborative group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial

Christine M. Goertz, Cynthia R. Long, Robert D. Vining, Katherine A. Pohlman, Bridget Kane, Lance Corber, Joan Walter, Ian Coulter

01.12.2016 | Letter | Ausgabe 1/2016 Open Access

Negotiating excess treatment costs in a clinical research trial: the good, the bad and the innovative

Rebecca Palmer, Madeleine Harrison, Elizabeth Cross, Pam Enderby

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Statistical analysis and handling of missing data in cluster randomized trials: a systematic review

Mallorie H. Fiero, Shuang Huang, Eyal Oren, Melanie L. Bell

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Dental practitioner recruitment for a randomized clinical trial in the field to evaluate the performance of a new glass ionomer restoration material

Thomas Klinke, Amro Daboul, Christian Schwahn, Roland Frankenberger, Reinhard Hickel, Reiner Biffar

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Progressive postresection program (pPRP) after pancreatic resection: study protocol for a randomized controlled trial

Susanne Richter, Verena Uslar, Navid Tabriz, Thomas Mueser, Dirk Weyhe

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparison of the influence of ticagrelor and clopidogrel on inflammatory biomarkers and vascular endothelial function for patients with ST-segment elevation myocardial infarction receiving emergency percutaneous coronary intervention: study protocol for a randomized controlled trial

Zhenhua Li, Yueyan Li, Tao Zhang, Wei Miao, Guohai Su

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Task sharing for the care of severe mental disorders in a low-income country (TaSCS): study protocol for a randomised, controlled, non-inferiority trial

Charlotte Hanlon, Atalay Alem, Girmay Medhin, Teshome Shibre, Dawit A. Ejigu, Hanna Negussie, Michael Dewey, Lawrence Wissow, Martin Prince, Ezra Susser, Crick Lund, Abebaw Fekadu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Acceptance and commitment therapy for adults with advanced cancer (CanACT): study protocol for a feasibility randomised controlled trial

Joseph Low, Marc Serfaty, Sarah Davis, Victoria Vickerstaff, Anna Gola, Rumana Z. Omar, Michael King, Adrian Tookman, Janet St John Austen, Karen Turner, Louise Jones

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Open data 5 years on: a case series of 12 freedom of information requests for regulatory data to the European Medicines Agency

Peter Doshi, Tom Jefferson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Investigating the feasibility and acceptability of a cognitive behavioural suicide prevention therapy for people in acute psychiatric wards (the ‘INSITE’ trial): study protocol for a randomised controlled trial

Gillian Haddock, Linda Davies, Emma Evans, Richard Emsley, Patricia Gooding, Lisa Heaney, Sarah Jones, James Kelly, Ailsa Munro, Sarah Peters, Daniel Pratt, Nicholas Tarrier, Kirsten Windfuhr, Yvonne Awenat

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study): study protocol for a cluster randomised controlled trial

David Osborn, Alexandra Burton, Kate Walters, Irwin Nazareth, Samira Heinkel, Lou Atkins, Ruth Blackburn, Richard Holt, Racheal Hunter, Michael King, Louise Marston, Susan Michie, Richard Morris, Steve Morris, Rumana Omar, Robert Peveler, Vanessa Pinfold, Ella Zomer, Thomas Barnes, Tom Craig, Hazel Gilbert, Ben Grey, Claire Johnston, Judy Leibowitz, Irene Petersen, Fiona Stevenson, Sheila Hardy, Vanessa Robinson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of blood flow restricted exercise compared with standard exercise in patients with recurrent low back pain: study protocol for a randomized controlled trial

Shinichi Amano, Arimi Fitri Mat Ludin, Rachel Clift, Masato Nakazawa, Timothy D. Law, Laura J. Rush, Todd M. Manini, James S. Thomas, David W. Russ, Brian C. Clark

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Improving access to primary care for Aboriginal babies in Western Australia: study protocol for a randomized controlled trial

Daniel McAullay, Kimberley McAuley, Rhonda Marriott, Glenn Pearson, Peter Jacoby, Chantal Ferguson, Elizabeth Geelhoed, Juli Coffin, Charmaine Green, Selina Sibosado, Barbara Henry, Dorota Doherty, Karen Edmond

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Screen-and-treat program by point-of-care of Atopobium vaginae and Gardnerella vaginalis in preventing preterm birth (AuTop trial): study protocol for a randomized controlled trial’

Florence Bretelle, Florence Fenollar, Karine Baumstarck, Cécile Fortanier, Jean François Cocallemen, Valérie Serazin, Didier Raoult, Pascal Auquier, Sandrine Loubière, the Groupe de Recherche en Obstétrique et Gynécologie (GROG)

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Study of endothelial function response to exercise training in hypertensive individuals (SEFRET): study protocol for a randomized controlled trial

Marinei Lopes Pedralli, Gustavo Waclawovsky, Augusto Camacho, Melissa Medeiros Markoski, Iran Castro, Alexandre Machado Lehnen

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Implementation of a telephone-based secondary preventive intervention after acute coronary syndrome (ACS): participation rate, reasons for non-participation and 1-year survival

Daniel Huber, Robin Henriksson, Stina Jakobsson, Nikolai Stenfors, Thomas Mooe

01.12.2016 | Reviewer acknowledgement | Ausgabe 1/2016 Open Access

Thanks to all those who reviewed for Trials in 2015

Douglas G. Altman, Curt D. Furberg, Jeremy M. Grimshaw

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial

Pierre Kalfon, Olivier Mimoz, Anderson Loundou, Marie-Agnès Geantot, Nathalie Revel, Isabelle Villard, Julien Amour, Elie Azoulay, Maïté Garrouste-Orgeas, Claude Martin, Tarek Sharshar, Karine Baumstarck, Pascal Auquier

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial

Godfrey B. Woelk, Mary Pat Kieffer, Damilola Walker, Daphne Mpofu, Rhoderick Machekano, the Project ACCLAIM Study Group

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial’

A. Solari, A. Giordano, M. G. Grasso, P. Confalonieri, F. Patti, A. Lugaresi, L. Palmisano, R. Amadeo, G. Martino, M. Ponzio, G. Casale, C. Borreani, R. Causarano, S. Veronese, P. Zaratin, M. A. Battaglia

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

One-stage or two-stage revision surgery for prosthetic hip joint infection – the INFORM trial: a study protocol for a randomised controlled trial

Simon Strange, Michael R. Whitehouse, Andrew D. Beswick, Tim Board, Amanda Burston, Ben Burston, Fran E. Carroll, Paul Dieppe, Kirsty Garfield, Rachael Gooberman-Hill, Stephen Jones, Setor Kunutsor, Athene Lane, Erik Lenguerrand, Alasdair MacGowan, Andrew Moore, Sian Noble, Joanne Simon, Ian Stockley, Adrian H. Taylor, Andrew Toms, Jason Webb, John-Paul Whittaker, Matthew Wilson, Vikki Wylde, Ashley W. Blom

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Physical therapy aimed at self-management versus usual care physical therapy after hip arthroscopy for femoroacetabular impingement: study protocol for a randomized controlled trial

M. Tijssen, R. E. H. van Cingel, J. B. Staal, S. Teerenstra, E. de Visser, M. W. G. Nijhuis-van der Sanden

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Design and rationale of the ATHENA study – A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial

Claudia Sommerer, Barbara Suwelack, Duska Dragun, Peter Schenker, Ingeborg A. Hauser, Björn Nashan, Friedrich Thaiss

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluation of an antenatal acupuncture intervention as an adjunct therapy for antenatal depression (AcuAnteDep): study protocol for a pragmatic randomised controlled trial

Simone M. Ormsby, Caroline A. Smith, Hannah G. Dahlen, Phillipa J. Hay, Joanne M. Lind

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Interventions to improve patients’ compliance with therapies aimed at lowering glycated hemoglobin (HbA1c) in type 1 diabetes: systematic review and meta-analyses of randomized controlled clinical trials of psychological, telecare, and educational interventions

Luciana Verçoza Viana, Marilia Brito Gomes, Lenita Zajdenverg, Elizabeth Joao Pavin, Mirela Jobim Azevedo, On Behalf of the Brazilian Type 1 Diabetes Study Group (BrazDiab1SG)

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Perioperative use of crystalloids in patients undergoing open radical cystectomy: balanced Ringer’s maleate versus a glucose 5 %/potassium-based balanced solution: study protocol for a randomized controlled trial’

Lukas M. Löffel, Bettina Kleeb, Fiona C. Burkhard, Patrick Y. Wuethrich

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Virtual reality cue exposure for the relapse prevention of tobacco consumption: a study protocol for a randomized controlled trial

Camille Giovancarli, Eric Malbos, Karine Baumstarck, Nathalie Parola, Marie-Florence Pélissier, Christophe Lançon, Pascal Auquier, Laurent Boyer

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The combined effect of subcutaneous granulocyte- colony stimulating factor and myocardial contrast echocardiography with intravenous infusion of sulfur hexafluoride on post-infarction left ventricular function, the RIGENERA 2.0 trial: study protocol for a randomized controlled trial

Antonio Maria Leone, Domenico D’Amario, Luciana Teofili, Eloisa Basile, Francesco Cannata, Francesca Graziani, Mario Marzilli, Antonio Matteo Russo, Giuseppe Tarantini, Claudio Ceconi, Giuseppe Leone, Carlo Trani, Antonio Giuseppe Rebuzzi, Filippo Crea

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Intravenous magnesium sulfate for the management of severe hand, foot, and mouth disease with autonomic nervous system dysregulation in Vietnamese children: study protocol for a randomized controlled trial

Phan Tu Qui, Truong Huu Khanh, Huynh Trung Trieu, Phạm Thanh Giang, Nguyen Ngọc Bich, Le Phan Kim Thoa, Le Nguyen Thanh Nhan, Saraswathy Sabanathan, Rogier Van Doorn, Nguyen Duc Toan, Laura Merson, Nguyen Thi Phuong Dung, Lam Phung Khanh, Marcel Wolbers, Nguyen Thanh Hung, Nguyen Van Vinh Chau, Bridget Wills

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy and safety of Qi-Wei-Qing-Yan aerosol in treatment of acute pharyngitis (lung-stomach excess-heat syndrome): study protocol for a randomized controlled trial

Hong-li Jiang, Bin She, Wei Liu, Bing Mao, Ju-ying Zhang

01.12.2016 | Research | Ausgabe 1/2016 Open Access

From protocol to published report: a study of consistency in the reporting of academic drug trials

Louise Berendt, Torbjörn Callréus, Lene Grejs Petersen, Karin Friis Bach, Henrik Enghusen Poulsen, Kim Dalhoff

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Impact of the condolence letter on the experience of bereaved families after a death in intensive care: study protocol for a randomized controlled trial

Nancy Kentish-Barnes, Sylvie Chevret, Elie Azoulay

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Impact of preoperative Vitamin D3 administration on postoperative hypocalcaemia in patients undergoing total thyroidectomy (HypoCalViD): study protocol for a randomized controlled trial

Stefanie Wolak, Mandy Scheunchen, Katharina Holzer, Mirjam Busch, Esra Trumpf, Andreas Zielke

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial

Cynthia Pine, Pauline Adair, Louise Robinson, Girvan Burnside, Paula Moynihan, William Wade, James Kistler, Morag Curnow, Mary Henderson

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

Recruiting to a large-scale physical activity randomised controlled trial – experiences with the gift of hindsight

Robert J. Copeland, Kimberley Horspool, Liam Humphreys, Emma Scott, on behalf of the Booster trial team

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of rehabilitation worker input on visual function outcomes in individuals with low vision: study protocol for a randomised controlled trial

Jennifer H. Acton, Bablin Molik, Alison Binns, Helen Court, Tom H. Margrain

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Activating clinical trials: a process improvement approach

Diego A. Martinez, Athanasios Tsalatsanis, Ali Yalcin, José L. Zayas-Castro, Benjamin Djulbegovic

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Increasing follow-up questionnaire response rates in a randomized controlled trial of telehealth for depression: three embedded controlled studies

Louisa Edwards, Chris Salisbury, Kimberley Horspool, Alexis Foster, Katy Garner, Alan A. Montgomery

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A prospective multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART Disc plus autologous disc chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disc to avoid secondary disease: study protocol for a randomized controlled trial

Anja Tschugg, Felix Michnacs, Martin Strowitzki, Hans Jörg Meisel, Claudius Thomé

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Novel patient engagement and recruitment strategies for an RCT of two NHS treatments for ankle osteoarthritis - total ankle replacement versus arthrodesis - the TARVA trial’

Andy Goldberg, Claire Thomson, Deirdre Brooking, Elin Rees, Marion Cumbers, Michelle Tetlow, Simon Skene, Suzie Cro

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A patient decision aid for antidepressant use in pregnancy: study protocol for a randomized controlled trial

Simone Vigod, Neesha Hussain-Shamsy, Sophie Grigoriadis, Louise M. Howard, Kelly Metcalfe, Tim F. Oberlander, Carrie Schram, Donna E. Stewart, Valerie H. Taylor, Cindy-Lee Dennis

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

RiMINI – the influence of rifaximin on minimal hepatic encephalopathy (MHE) and on the intestinal microbiome in patients with liver cirrhosis: study protocol for a randomized controlled trial

Christian Schulz, Kerstin Schütte, Siegfried Kropf, Friedhelm C. Schmitt, Riccardo Vasapolli, Leon M. Kliegis, Antonia Riegger, Peter Malfertheiner

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Impact of routine coronary catheterization in low extremity artery disease undergoing percutaneous transluminal angioplasty: study protocol for a multi-center randomized controlled trial

I-Chih Chen, Cheng-Han Lee, Ting-Hsing Chao, Wei-Kung Tseng, Tsung-Hsien Lin, Wen-Jung Chung, Jen-Kwan Li, Hsuan-Li Huang, Ping-Yen Liu, Ting-Kuang Chao, Chuin-Yuan Chu, Chih-Chan Lin, Po-Chao Hsu, Wen-Huang Lee, Po-Tseng Lee, Yi-Heng Li, Shih-Ya Tseng, Liang-Miin Tsai, Juey-Jen Hwang

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The clinical and cost effectiveness of cognitive behavioural therapy plus treatment as usual for the treatment of depression in advanced cancer (CanTalk): study protocol for a randomised controlled trial

Marc Serfaty, Michael King, Irwin Nazareth, Adrian Tookman, John Wood, Anna Gola, Trefor Aspden, Kathryn Mannix, Sarah Davis, Stirling Moorey, Louise Jones

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

APOLO-Bari, an internet-based program for longitudinal support of bariatric surgery patients: study protocol for a randomized controlled trial

Eva M. Conceição, Paulo P. P. Machado, Ana Rita Vaz, Ana Pinto-Bastos, Sofia Ramalho, Cátia Silva, Filipa Arrojado

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial

Cherry-Ann Waldron, Emma Thomas-Jones, Rebecca Cannings-John, Kerenza Hood, Colin Powell, Amanda Roberts, Alun Tomkinson, Deborah Fitzsimmons, Micaela Gal, Debbie Harris, Victoria Shepherd, Christopher C Butler, Nicholas Francis

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Oxford Lithium Trial (OxLith) of the early affective, cognitive, neural and biochemical effects of lithium carbonate in bipolar disorder: study protocol for a randomised controlled trial

Kate E. A. Saunders, Andrea Cipriani, Jennifer Rendell, Mary-Jane Attenburrow, Natalie Nelissen, Amy C. Bilderbeck, Sridhar R. Vasudevan, Grant Churchill, Guy M. Goodwin, Anna C. Nobre, Catherine J. Harmer, Paul J. Harrison, John R. Geddes

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

On-site bundled rapid HIV/HCV testing in substance use disorder treatment programs: study protocol for a hybrid design randomized controlled trial

Jemima A. Frimpong, Thomas D’Aunno, David C. Perlman, Shiela M. Strauss, Alissa Mallow, Diana Hernandez, Bruce R. Schackman, Daniel J. Feaster, Lisa R. Metsch

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Sequential psychological and pharmacological therapies for comorbid and primary insomnia: study protocol for a randomized controlled trial

Charles M. Morin, Jack D. Edinger, Andrew D. Krystal, Daniel J. Buysse, Simon Beaulieu-Bonneau, Hans Ivers

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial

Penelope Abbott, Hasantha Gunasekera, Amanda Jane Leach, Deborah Askew, Robyn Walsh, Kelvin Kong, Federico Girosi, Chelsea Bond, Peter Morris, Sanja Lujic, Wendy Hu, Tim Usherwood, Sissy Tyson, Geoffrey Spurling, Markeeta Douglas, Kira Schubert, Shavaun Chapman, Nadeem Siddiqui, Reeion Murray, Keitha Rabbitt, Bobby Porykali, Cheryl Woodall, Tina Newman, Jennifer Reath

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Rectal indomethacin alone versus indomethacin and prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol for a randomized controlled trial

B. Joseph Elmunzer, Jose Serrano, Amitabh Chak, Steven A. Edmundowicz, Georgios I. Papachristou, James M. Scheiman, Vikesh K. Singh, Shyam Varadurajulu, John J. Vargo, Field F. Willingham, Todd H. Baron, Gregory A. Coté, Joseph Romagnuolo, April Wood-Williams, Emily K. Depue, Rebecca L. Spitzer, Cathie Spino, Lydia D. Foster, Valerie Durkalski, on behalf of the SVI study group and the United States Cooperative for Outcomes Research in Endoscopy (USCORE)

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Using a tailored health information technology- driven intervention to improve health literacy and medication adherence in a Pakistani population with vascular disease (Talking Rx) – study protocol for a randomized controlled trial

Ayeesha Kamran Kamal, Abdul Muqeet, Kashfa Farhat, Wardah Khalid, Anum Jamil, Ambreen Gowani, Aliya Amin Muhammad, Fabiha Zaidi, Danyal Khan, Touseef Elahi, Shahrukh Sharif, Sibtain Raz, Taha Zafar, Syedah Saira Bokhari, Nasir Rahman, Fateh Ali Tipoo Sultan, Saleem Sayani, Salim S. Virani

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns: study protocol for a randomized controlled trial

Zjir M. Rashaan, Pieta Krijnen, M. Elske van den Akker- van Marle, Margriet E. van Baar, Adrianus F. P. Vloemans, Jan Dokter, Fenike R. H. Tempelman, Cees H. van der Vlies, Roelf S. Breederveld

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Prostate cancer - evidence of exercise and nutrition trial (PrEvENT): study protocol for a randomised controlled feasibility trial

Lucy Hackshaw-McGeagh, J. Athene Lane, Raj Persad, David Gillatt, Jeff M. P. Holly, Anthony Koupparis, Edward Rowe, Lyndsey Johnston, Jenny Cloete, Constance Shiridzinomwa, Paul Abrams, Chris M. Penfold, Amit Bahl, Jon Oxley, Claire M. Perks, Richard Martin

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A multicenter randomized controlled open-label trial to assess the efficacy of compound kushen injection in combination with single-agent chemotherapy in treatment of elderly patients with advanced non-small cell lung cancer: study protocol for a randomized controlled trial

Xue-qian Wang, Jie Liu, Hong-sheng Lin, Wei Hou

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The functional and clinical outcomes of exercise training following a very low energy diet for severely obese women: study protocol for a randomised controlled trial

Clint T. Miller, Steve F. Fraser, Steve E. Selig, Toni Rice, Mariee Grima, Nora E. Straznicky, Itamar Levinger, Elisabeth A. Lambert, Daniel J. van den Hoek, John B. Dixon

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Effectiveness of a behavioral incentive scheme linked to goal achievement: study protocol for a randomized controlled trial’

Julie Redfern, Gemma Enright, Simon Raadsma, Margaret Allman-Farinelli, Christine Innes-Hughes, Santosh Khanal, Sarah Lukeis, Chris Rissel, Alex Gyani

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Preoperative radiochemotherapy versus immediate surgery for resectable and borderline resectable pancreatic cancer (PREOPANC trial): study protocol for a multicentre randomized controlled trial

Eva Versteijne, Casper H. J. van Eijck, Cornelis J. A. Punt, Mustafa Suker, Aeilko H. Zwinderman, Miriam A. C. Dohmen, Karin B. C. Groothuis, Oliver R. C. Busch, Marc G. H. Besselink, Ignace H. J. T. de Hingh, Albert J. ten Tije, Gijs A. Patijn, Bert A. Bonsing, Judith de Vos-Geelen, Joost M. Klaase, Sebastiaan Festen, Djamila Boerma, Joris I. Erdmann, I. Quintus. Molenaar, Erwin van der Harst, Marion B. van der Kolk, Coen R. N. Rasch, Geertjan van Tienhoven, for the Dutch Pancreatic Cancer Group (DPCG)

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial

Kate Jongbloed, Anton J. Friedman, Margo E. Pearce, Mia L. Van Der Kop, Vicky Thomas, Lou Demerais, Sherri Pooyak, Martin T. Schechter, Richard T. Lester, Patricia M. Spittal, The Cedar Project Partnership

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial spasm compared to standard care: study protocol for a randomised controlled trial

Sadie Wickwar, Hayley McBain, Stanton P. Newman, Shashivadan P. Hirani, Catherine Hurt, Nicola Dunlop, Chris Flood, Daniel G. Ezra

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial

Dimitrios A. Koutoukidis, Rebecca J. Beeken, Ranjit Manchanda, Matthew Burnell, M. Tish Knobf, Anne Lanceley

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Appraising the uptake and use of recommendations for a common outcome data set for clinical trials: a case study in fall injury prevention

Bethan Copsey, Sally Hopewell, Clemens Becker, Ian D. Cameron, Sarah E. Lamb

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial

Alice M. Couwenberg, Maarten J. P. Burbach, Anke B. Smits, Marco Van Vulpen, Wilhemina M. U. Van Grevenstein, Peter G. Noordzij, Helena M. Verkooijen

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Recruitment challenges in clinical research including cancer patients and their caregivers. A randomized controlled trial study and lessons learned’

Karin Sygna, Safora Johansen, Cornelia M. Ruland

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The efficacy of a new translational treatment for persecutory delusions: study protocol for a randomised controlled trial (The Feeling Safe Study)

Daniel Freeman, Felicity Waite, Richard Emsley, David Kingdon, Linda Davies, Ray Fitzpatrick, Graham Dunn

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Community and District Empowerment for Scale-up (CODES): a complex district-level management intervention to improve child survival in Uganda: study protocol for a randomized controlled trial

Peter Waiswa, Thomas O’Connell, Danstan Bagenda, Pricila Mullachery, Flavia Mpanga, Dorcus Kiwanuka Henriksson, Anne Ruhweza Katahoire, Eric Ssegujja, Anthony K. Mbonye, Stefan Swartling Peterson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Cognitive remediation versus active computer control in bipolar disorder with psychosis: study protocol for a randomized controlled trial

Kathryn Eve Lewandowski, Sarah H. Sperry, Dost Ongur, Bruce M. Cohen, Lesley A. Norris, Matcheri S. Keshavan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

RECCAS - REmoval of Cytokines during CArdiac Surgery: study protocol for a randomised controlled trial

Andreas Baumann, Dirk Buchwald, Thorsten Annecke, Martin Hellmich, Peter K Zahn, Andreas Hohn

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Contacting authors to retrieve individual patient data: study protocol for a randomized controlled trial

Areti Angeliki Veroniki, Sharon E. Straus, Huda Ashoor, Lesley A. Stewart, Mike Clarke, Andrea C. Tricco

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Beneficial effect of xylose consumption on postprandial hyperglycemia in Korean: a randomized double-blind, crossover design

Yun Ju Jun, Jinhee Lee, Sehee Hwang, Jung Hyun Kwak, Hyeon Yeong Ahn, Youn Kyung Bak, Jihoon Koh, Jong Ho Lee

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Oral PSORI-CM01, a Chinese herbal formula, plus topical sequential therapy for moderate-to-severe psoriasis vulgaris: pilot study for a double-blind, randomized, placebo-controlled trial

Dan-Ni Yao, Chuan-Jian Lu, Ze-Huai Wen, Yu-Hong Yan, Mei-Ling Xuan, Xiao-Yan Li, Geng Li, Ze-Hui He, Xiu-Li Xie, Jing-Wen Deng, Xin-Feng Guo, Ai-Hua Ou

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Glutamatergic medication in the treatment of obsessive compulsive disorder (OCD) and autism spectrum disorder (ASD) – study protocol for a randomised controlled trial

Alexander Häge, Tobias Banaschewski, Jan K. Buitelaar, Rick M. Dijkhuizen, Barbara Franke, David J. Lythgoe, Konstantin Mechler, Steven C. R. Williams, Ralf W. Dittmann, the TACTICS Consortium

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Xuebijing injection in the treatment of severe pneumonia: study protocol for a randomized controlled trial

Ping Wang, Yuanlin Song, Zhi Liu, Hui Wang, Wenke Zheng, Si Liu, Zhiqiao Feng, Jingbo Zhai, Chen Yao, Ming Ren, Chunxue Bai, Hongcai Shang

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial

Mariana Widmer, Gilda Piaggio, Hany Abdel-Aleem, Guillermo Carroli, Yap-Seng Chong, Arri Coomarasamy, Bukola Fawole, Shivaprasad Goudar, G. Justus Hofmeyr, Pisake Lumbiganon, Kidza Mugerwa, Thi My Huong Nguyen, Zahida Qureshi, Joao Paulo Souza, A. Metin Gülmezoglu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy of an educational intervention in primary health care in inhalation techniques: study protocol for a pragmatic cluster randomised controlled trial

José Leiva-Fernández, Rubén L. Vázquez-Alarcón, Virginia Aguiar-Leiva, Mireya Lobnig-Becerra, Francisca Leiva-Fernández, Pilar Barnestein-Fonseca

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A behavioural change package to prevent hand dermatitis in nurses working in the national health service (the SCIN trial): study protocol for a cluster randomised controlled trial

Ira Madan, Vaughan Parsons, Barry Cookson, John English, Tina Lavender, Paul McCrone, Caroline Murphy, Georgia Ntani, Lesley Rushton, Julia Smedley, Hywel Williams, Alison Wright, David Coggon

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The biomechanical effect of acupuncture for poststroke cavovarus foot: study protocol for a randomized controlled pilot trial

Yong Zhang, Hongwei Liu, Caihong Fu, Yanzhe Ning, Jiajia Zhang, Li Zhou, Zongheng Li, Peng Bai

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Dorsal penile nerve block for rigid cystoscopy in men: study protocol for a randomized controlled trial

Yan Qiu, An-min Hu, Jin Liu, Gui-zhi Du

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (The ELAIN-Trial): study protocol for a randomized controlled trial

Alexander Zarbock, Joachim Gerß, Hugo Van Aken, Andreea Boanta, John A. Kellum, Melanie Meersch

01.12.2016 | Letter | Ausgabe 1/2016 Open Access

Sample size calculations in clinical research should also be based on ethical principles

Bruno Mario Cesana, Paolo Antonelli

01.12.2016 | Review | Ausgabe 1/2016 Open Access

Adaptive designs undertaken in clinical research: a review of registered clinical trials

Isabella Hatfield, Annabel Allison, Laura Flight, Steven A. Julious, Munyaradzi Dimairo

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial’

Chinwe Onu, Linnet Ongeri, Elizabeth Bukusi, Craig R. Cohen, Thomas C. Neylan, Patrick Oyaro, Grace Rota, Faith Otewa, Kevin L. Delucchi, Susan M. Meffert

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Cognitive rehabiliation for Parkinson's disease dementia: a study protocol for a pilot randomised controlled trial

John V Hindle, Tamlyn J Watermeyer, Julie Roberts, Anthony Martyr, Huw Lloyd-Williams, Andrew Brand, Petra Gutting, Zoe Hoare, Rhiannon Tudor Edwards, Linda Clare

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Reducing the psychosocial impact of aphasia on mood and quality of life in people with aphasia and the impact of caregiving in family members through the Aphasia Action Success Knowledge (Aphasia ASK) program: study protocol for a randomized controlled trial

Linda Worrall, Brooke Ryan, Kyla Hudson, Ian Kneebone, Nina Simmons-Mackie, Asaduzzaman Khan, Tammy Hoffmann, Emma Power, Leanne Togher, Miranda Rose

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

An Ecological Momentary Intervention for weight loss and healthy eating via smartphone and Internet: study protocol for a randomised controlled trial

Bastiaan Boh, Lotte H. J. M. Lemmens, Anita Jansen, Chantal Nederkoorn, Vincent Kerkhofs, Gerasimos Spanakis, Gerhard Weiss, Anne Roefs

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy and safety of carbetocin applied as an intravenous bolus compared to as a short-infusion for caesarean section: study protocol for a randomised controlled trial

Salome Dell-Kuster, Irene Hoesli, Olav Lapaire, Esther Seeberger, Luzius A. Steiner, Heiner C. Bucher, Thierry Girard

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Adapting and testing a brief intervention to reduce maternal anxiety during pregnancy (ACORN): study protocol for a randomised controlled trial

Esther L. Wilkinson, Heather A. O’Mahen, Pasco Fearon, Sarah Halligan, Dorothy X. King, Geva Greenfield, Jacqueline Dunkley-Bent, Jennifer Ericksen, Jeannette Milgrom, Paul G. Ramchandani

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Tablet-Aided BehavioraL intervention EffecT on Self-management skills (TABLETS) for Diabetes

Cheryl P. Lynch, Joni S. Williams, Kenneth J. Ruggiero, Rebecca G. Knapp, Leonard E. Egede

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The CORE Service Improvement Programme for mental health crisis resolution teams: study protocol for a cluster-randomised controlled trial

Brynmor Lloyd-Evans, Kate Fullarton, Danielle Lamb, Elaine Johnston, Steve Onyett, David Osborn, Gareth Ambler, Louise Marston, Rachael Hunter, Oliver Mason, Claire Henderson, Nicky Goater, Sarah A. Sullivan, Kathleen Kelly, Richard Gray, Fiona Nolan, Stephen Pilling, Gary Bond, Sonia Johnson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Perioperative hemodynamic optimization using the photoplethysmography in colorectal surgery (the PANEX3 trial): study protocol for a randomized controlled trial

Marc-Olivier Fischer, Anne-Lise Fiant, Mariam Boutros, Frédéric Flais, Tzetan Filipov, Stéphane Debroczi, Léa Pasqualini, Toufiq Rhanem, Jean-Louis Gérard, Lydia Guittet, Jean-Luc Hanouz, Arnaud Alves, Jean-Jacques Parienti, For the PANEX3 study group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparison of exenatide with biphasic insulin aspart 30 on glucose variability in type 2 diabetes: study protocol for a randomized controlled trial

Shaoyong Xu, Xiangyang Liu, Jie Ming, Qiuhe Ji

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Morita therapy for depression and anxiety (Morita Trial): study protocol for a pilot randomised controlled trial

Holly Victoria Rose Sugg, David A. Richards, Julia Frost

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Supporting Treatment Adherence Readiness through Training (START) for patients with HIV on antiretroviral therapy: study protocol for a randomized controlled trial

Glenn J. Wagner, Sebastien Linnemayr, Bonnie Ghosh-Dastidar, Judith S. Currier, Risa Hoffman, Stefan Schneider

01.12.2016 | Research | Ausgabe 1/2016 Open Access

An analysis of baseline data from the PROUD study: an open-label randomised trial of pre-exposure prophylaxis

David I. Dolling, Monica Desai, Alan McOwan, Richard Gilson, Amanda Clarke, Martin Fisher, Gabriel Schembri, Ann K. Sullivan, Nicola Mackie, Iain Reeves, Mags Portman, John Saunders, Julie Fox, Jake Bayley, Michael Brady, Christine Bowman, Charles J. Lacey, Stephen Taylor, David White, Simone Antonucci, Mitzy Gafos, Sheena McCormack, Owen N. Gill, David T. Dunn, Anthony Nardone, On behalf of the PROUD Study Group

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

OpenTrials: towards a collaborative open database of all available information on all clinical trials

Ben Goldacre, Jonathan Gray

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Dementia and Physical Activity (DAPA) - an exercise intervention to improve cognition in people with mild to moderate dementia: study protocol for a randomized controlled trial

Nicky Atherton, Chris Bridle, Deborah Brown, Helen Collins, Sukhdeep Dosanjh, Frances Griffiths, Susie Hennings, Kamran Khan, Ranjit Lall, Samantha Lyle, Rupert McShane, Dipesh Mistry, Vivien Nichols, Stavros Petrou, Bart Sheehan, Anne-Marie Slowther, Margaret Thorogood, Emma Withers, Peter Zeh, Sarah E. Lamb

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Reconstructing communities in cluster trials?

Sapfo Lignou, Sushmita Das, Jigna Mistry, Glyn Alcock, Neena Shah More, David Osrin, Sarah J. L. Edwards

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Effects of indexes of consciousness (IoC1 and IoC2) monitoring on remifentanil dosage in modified radical mastectomy: a randomized trial

Guisheng Wu, Lei Zhang, Xuxiang Wang, Ailan Yu, Zongwang Zhang, Jingui Yu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of transcutaneous electrical nerve stimulation (TENS) on arterial stiffness and blood pressure in resistant hypertensive individuals: study protocol for a randomized controlled trial

José Fernando Vilela-Martin, Luiz Tadeu Giollo-Junior, Gaspar Rogério Chiappa, Gerson Cipriano-Junior, Paulo José Cardoso Vieira, Fábio dos Santos Ricardi, Manoel Ildefonso Paz-Landim, Days Oliveira de Andrade, Elizabeth do Espírito Santo Cestário, Luciana Neves Cosenso-Martin, Juan Carlos Yugar-Toledo, José Paulo Cipullo

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Atraumatic Restorative Treatment compared to the Hall Technique for occluso-proximal cavities in primary molars: study protocol for a randomized controlled trial

Daniela Hesse, Mariana Pinheiro de Araujo, Isabel Cristina Olegário, Nicola Innes, Daniela Prócida Raggio, Clarissa Calil Bonifácio

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

CAMERA2 – combination antibiotic therapy for methicillin-resistant Staphylococcus aureus infection: study protocol for a randomised controlled trial

Steven Y. C. Tong, Jane Nelson, David L. Paterson, Vance G. Fowler Jr, Benjamin P. Howden, Allen C. Cheng, Mark Chatfield, Jeffrey Lipman, Sebastian Van Hal, Matthew O’Sullivan, James O. Robinson, Dafna Yahav, David Lye, Joshua S. Davis, for the CAMERA2 study group and the Australasian Society for Infectious Diseases Clinical Research Network

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial

Christina Hunger, Rebecca Hilzinger, Theresa Koch, Johannes Mander, Anja Sander, Hinrich Bents, Jochen Schweitzer

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

An Internet-based self-help intervention for people with HIV and depressive symptoms: study protocol for a randomized controlled trial

Sanne van Luenen, Vivian Kraaij, Philip Spinhoven, Nadia Garnefski

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of a transitional palliative care model on patients with end-stage heart failure: study protocol for a randomized controlled trial

Alina Yee Man Ng, Frances Kam Yuet Wong, Paul Hong Lee

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A randomized clinical trial to determine the effectiveness of CO-oximetry and anti-smoking brief advice in a cohort of kidney transplant patients who smoke: study protocol for a randomized controlled trial

Salvador Pita-Fernández, Rocío Seijo-Bestilleiro, Sonia Pértega-Díaz, Ángel Alonso-Hernández, Constantino Fernández-Rivera, Mercedes Cao-López, Teresa Seoane-Pillado, Beatriz López-Calviño, Cristina González-Martín, Francisco Valdés-Cañedo

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial

Gillian Watson, James O’Hara, Paul Carding, Jan Lecouturier, Deborah Stocken, Tony Fouweather, Janet Wilson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Supervised progressive cross-continuum strength training compared with usual care in older medical patients: study protocol for a randomized controlled trial (the STAND-Cph trial)

Mette Merete Pedersen, Janne Petersen, Nina Beyer, Lars Damkjær, Thomas Bandholm

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Engaging adolescents in tuberculosis and clinical trial research through drama

Bey-Marrié Schmidt, Amber Abrams, Michele Tameris

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Exploring non-participation in primary care physical activity interventions: PACE-UP trial interview findings

Rebecca Normansell, Rebecca Holmes, Christina Victor, Derek G Cook, Sally Kerry, Steve Iliffe, Michael Ussher, Julia Fox-Rushby, Peter Whincup, Tess Harris

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial

Rosie Dobson, Robyn Whittaker, Yannan Jiang, Matthew Shepherd, Ralph Maddison, Karen Carter, Richard Cutfield, Catherine McNamara, Manish Khanolkar, Rinki Murphy

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of communication training with the MAAS-Global-D instrument on the antibiotic prescribing for respiratory infections in primary care: study protocol of a randomised controlled trial

Friederike Hammersen, Katja Goetz, Andreas Soennichsen, Timo Emcke, Jost Steinhaeuser

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of pharmaceutical care for drug treatment adherence in patients with systemic lupus erythematosus in Rio de Janeiro, Brazil: study protocol for a randomized controlled trial

Marise Oliveira-Santos, José Fernando de Souza Verani, Luiz Antônio Bastos Camacho, Carlos Augusto Ferreira de Andrade, Rosele Ferrante-Silva, Evandro Mendes Klumb

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy and safety of intravenous paracetamol in comparison to ibuprofen for the treatment of patent ductus arteriosus in preterm infants: study protocol for a randomized control trial

Carlo Dani, Chiara Poggi, Fabio Mosca, Federico Schena, Gianluca Lista, Luca Ramenghi, Costantino Romagnoli, Enrica Salvatori, Maria Teresa Rosignoli, Paola Lipone, Alessandro Comandini

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of acupuncture and its influence on cerebral activity in functional dyspepsia patients: study protocol for a randomized controlled trial

Seok-Jae Ko, Kyungmo Park, Jieun Kim, Minji Kim, Joo-Hee Kim, Jeungchan Lee, Abdalla Z. Mohamed, Inkwon Yeo, Jinsung Kim, Sun-Mi Choi, Honggeol Kim, Jae-Woo Park, Jun-Hwan Lee

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluating a computer aid for assessing stomach symptoms (ECASS): study protocol for a randomised controlled trial

Helen J. Moore, Catherine Nixon, Anisah Tariq, Jon Emery, Willie Hamilton, Zoë Hoare, Anne Kershenbaum, Richard D. Neal, Obioha C. Ukoumunne, Juliet Usher-Smith, Fiona M. Walter, Sophie Whyte, Greg Rubin

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The clinical and cost effectiveness of a Breathlessness Intervention Service for patients with advanced non-malignant disease and their informal carers: mixed findings of a mixed method randomised controlled trial

Morag C. Farquhar, A. Toby Prevost, Paul McCrone, Barbara Brafman-Price, Allison Bentley, Irene J. Higginson, Chris J. Todd, Sara Booth

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial

Christina Kruse, Sascha A. Müller, René Warschkow, Cornelia Lüthi, Walter Brunner, Lukas Marti, Michael Christian Sulz, Bruno M. Schmied, Ignazio Tarantino, Ulrich Beutner

01.12.2016 | Research | Ausgabe 1/2016 Open Access

When are clinical trials registered? An analysis of prospective versus retrospective registration

Stephanie L. Harriman, Jigisha Patel

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effectiveness of Technology-assisted Cascade Training and Supervision of community health workers in delivering the Thinking Healthy Program for perinatal depression in a post-conflict area of Pakistan – study protocol for a randomized controlled trial

Shamsa Zafar, Siham Sikander, Syed Usman Hamdani, Najia Atif, Parveen Akhtar, Huma Nazir, Joanna Maselko, Atif Rahman

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain

Robert N. Girandola, Shalini Srivastava, Costas C. Loullis

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial

David Pickham, Betsy Ballew, Kristi Ebong, Julie Shinn, Mary E. Lough, Barbara Mayer

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Sublobar resection versus lobectomy in Surgical Treatment of Elderly Patients with early-stage non-small cell lung cancer (STEPS): study protocol for a randomized controlled trial

Fan Yang, Xizhao Sui, Xiuyuan Chen, Lixue Zhang, Xun Wang, Shaodong Wang, Jun Wang

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Aspirin in venous leg ulcer study (ASPiVLU): study protocol for a randomised controlled trial

Carolina D. Weller, Anna Barker, Ian Darby, Terrence Haines, Martin Underwood, Stephanie Ward, Pat Aldons, Elizabeth Dapiran, Jason J. Madan, Paula Loveland, Sankar Sinha, Mauro Vicaretti, Rory Wolfe, Michael Woodward, John McNeil

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

E-care 4 caregivers – an online intervention for nonprofessional caregivers of patients with depression: study protocol for a pilot randomized controlled trial

L. Bijker, A. Kleiboer, H. Riper, P. Cuijpers, T. Donker

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Intravenous versus epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy (the PAKMAN trial, DRKS 00007784): study protocol for a randomized controlled trial

Rosa Klotz, Stefan Hofer, Alexander Schellhaaß, Colette Dörr-Harim, Solveig Tenckhoff, Thomas Bruckner, Christina Klose, Markus K. Diener, Markus A. Weigand, Markus W. Büchler, Phillip Knebel

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals

Julia Lawton, Claire Snowdon, Susan Morrow, Jane E. Norman, Fiona C. Denison, Nina Hallowell

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Postoperative intravenously administered iron sucrose versus postoperative orally administered iron to treat post-bariatric abdominoplasty anaemia (ISAPA): the study protocol for a randomised controlled trial

Juan Carlos Montano-Pedroso, Elvio Bueno Garcia, Neil Ferreira Novo, Daniela Francescato Veiga, Lydia Masako Ferreira

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Electroacupuncture versus sham electroacupuncture for urinary retention in poststroke patients: study protocol for a multicenter, randomized controlled trial

Seungwon Shin, Jiwon Lee, Junghee Yoo, Sung Min Lim, Euiju Lee

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparing endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) versus fine needle biopsy (FNB) in the diagnosis of solid lesions: study protocol for a randomized controlled trial

Jinlin Wang, Xiaoli Wu, Ping Yin, Qiaozhen Guo, Wei Hou, Yawen Li, Yun Wang, Bin Cheng

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 U.S. Food and Drug Administration approvals

Nicholas S. Downing, Nilay D. Shah, Joseph H. Neiman, Jenerius A. Aminawung, Harlan M. Krumholz, Joseph S. Ross

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Acetyl-L-carnitine (ALCAR) to enhance nerve regeneration in carpal tunnel syndrome: study protocol for a randomized, placebo-controlled trial

Matthew W. T. Curran, Jaret Olson, Michael Morhart, Dory Sample, K. Ming Chan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of a clinical guideline to improve dental health among orthodontically treated patients: study protocol for a cluster randomized controlled trial

Barbara C. M. Oosterkamp, Afzal Wafae, Jan G. J. H. Schols, Wil J. M. van der Sanden, Michel Wensing

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Improving maternity care using a personal health record: study protocol for a stepped-wedge, randomised, controlled trial

Carola J. M. Groenen, Marjan J. Faber, Jan A. M. Kremer, Frank P. H. A. Vandenbussche, Noortje T. L. van Duijnhoven

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

“FIND Technology”: investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial

M. L. Bird, J. Cannell, M. L. Callisaya, E. Moles, A. Rathjen, K. Lane, A. Tyson, S. Smith

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effects of improved sanitation on diarrheal prevalence, incidence, and duration in children under five in the SNNPR State, Ethiopia: study protocol for a randomized controlled trial

Sunghoon Jung, Young-Ah Doh, Dawit Belew Bizuneh, Habtamu Beyene, Jieun Seong, Hyunjin Kwon, Yongwhan Kim, Girma Negussie Habteyes, Yigrem Tefera, Seungman Cha

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Stress ulcer prophylaxis with a proton pump inhibitor versus placebo in critically ill patients (SUP-ICU trial): study protocol for a randomised controlled trial

Mette Krag, Anders Perner, Jørn Wetterslev, Matt P. Wise, Mark Borthwick, Stepani Bendel, Paolo Pelosi, Frederik Keus, Anne Berit Guttormsen, Joerg C. Schefold, Morten Hylander Møller, the SUP-ICU investigators

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Implementation of foot thermometry plus mHealth to prevent diabetic foot ulcers: study protocol for a randomized controlled trial

Maria Lazo-Porras, Antonio Bernabe-Ortiz, Katherine A. Sacksteder, Robert H. Gilman, German Malaga, David G. Armstrong, J. Jaime Miranda

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Reporting of harms outcomes: a comparison of journal publications with unpublished clinical study reports of orlistat trials

Alex Hodkinson, Carrol Gamble, Catrin Tudur Smith

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effects of prolonged wear of textured shoe insoles on gait, foot sensation and proprioception in people with multiple sclerosis: study protocol for a randomised controlled trial

Anna L. Hatton, John Dixon, Keith Rome, Sandra G. Brauer, Katrina Williams, Graham Kerr

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effectiveness of mindfulness-based stress reduction (MBSR) for survivors of breast cancer: study protocol for a randomized controlled trial

Jiayan Huang, Lu Shi

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluation of a novel information resource for patients with bronchiectasis: study protocol for a randomised controlled trial

Katy L. M. Hester, Julia Newton, Tim Rapley, Anthony De Soyza

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Quantity, topics, methods and findings of randomised controlled trials published by German university departments of general practice – systematic review

Stefan Heinmüller, Antonius Schneider, Klaus Linde, for the DFG Network Clinical Trials in General Practice

01.12.2016 | Research | Ausgabe 1/2016 Open Access

‘The trial is owned by the team, not by an individual’: a qualitative study exploring the role of teamwork in recruitment to randomised controlled trials in surgical oncology

Sean Strong, Sangeetha Paramasivan, Nicola Mills, Caroline Wilson, Jenny L. Donovan, Jane M. Blazeby

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Dependability of results in conference abstracts of randomized controlled trials in ophthalmology and author financial conflicts of interest as a factor associated with full publication

Ian J. Saldanha, Roberta W. Scherer, Isabel Rodriguez-Barraquer, Henry D. Jampel, Kay Dickersin

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Interim pressure garment therapy (4–6 mmHg) and its effect on donor site healing in burn patients: study protocol for a randomised controlled trial

Michelle L. Donovan, Michael J. Muller, Claire Simpson, Michael Rudd, Jennifer Paratz

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial

Jutta K. H. Skau, Awatef Binti Amer Nordin, Julius C. H. Cheah, Roslinah Ali, Ramli Zainal, Tahir Aris, Zainudin Mohd Ali, Priya Matzen, Regien Biesma, Jens Aagaard-Hansen, Mark A. Hanson, Shane A. Norris

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Pipelle for Pregnancy (PIP): study protocols for three randomised controlled trials

Sarah Lensen, Wellington Martins, Carolina Nastri, Lynn Sadler, Cindy Farquhar

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: CASPER plus (CollAborative care in screen-positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial

Karen Overend, Helen Lewis, Della Bailey, Kate Bosanquet, Carolyn Chew-Graham, David Ekers, Samantha Gascoyne, Deborah Hems, John Holmes, Ada Keding, Dean McMillan, Shaista Meer, Jodi Meredith, Natasha Mitchell, Sarah Nutbrown, Steve Parrott, David Richards, Gemma Traviss, Dominic Trépel, Rebecca Woodhouse, Simon Gilbody

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A high-selenium lentil dietary intervention in Bangladesh to counteract arsenic toxicity: study protocol for a randomized controlled trial

Regina M. Krohn, Rubhana Raqib, Evana Akhtar, Albert Vandenberg, Judit E. G. Smits

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A qualitative exploration of trial-related terminology in a study involving Deaf British Sign Language users

Alys Young, Rosemary Oram, Claire Dodds, Catherine Nassimi-Green, Rachel Belk, Katherine Rogers, Linda Davies, Karina Lovell

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial

Christopher Williams, Carrie-Anne McClay, Rebeca Martinez, Jill Morrison, Caroline Haig, Ray Jones, Paul Farrand

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials

Eva O. Melin, Ralph Svensson, Sven-Åke Gustavsson, Agneta Winberg, Ewa Denward-Olah, Mona Landin-Olsson, Hans O. Thulesius

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Modelling variable dropout in randomised controlled trials with longitudinal outcomes: application to the MAGNETIC study

Ruwanthi Kolamunnage-Dona, Colin Powell, Paula Ruth Williamson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of medical hypnosis for pain reduction and faster wound healing in pediatric acute burn injury: study protocol for a randomized controlled trial

Stephen J. Chester, Kellie Stockton, Alexandra De Young, Belinda Kipping, Zephanie Tyack, Bronwyn Griffin, Ralph L. Chester, Roy M. Kimble

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial

Robert B. Saper, Chelsey M. Lemaster, A. Rani Elwy, Ruth Paris, Patricia M. Herman, Dorothy N. Plumb, Karen J. Sherman, Erik J. Groessl, Susan Lynch, Shihwe Wang, Janice Weinberg

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Dedicated call center (SOS-HAE) for hereditary angioedema attacks: study protocol for a randomised controlled trial

Nicolas Javaud, Olivier Fain, Isabelle Durand-Zaleski, David Launay, Laurence Bouillet, Anne Gompel, Alain Sobel, Maguy Woimant, Hasina Rabetrano, Tomislav Petrovic, Frédéric Lapostolle, Isabelle Boccon-Gibod, Paul-Georges Reuter, Philippe Bertrand, Brigitte Coppere, Bernard Floccard, Gisele Kanny, Ludovic Martin, Eric Vicaut, Frédéric Adnet

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effect of providing feedback on inhaler technique and adherence from an electronic audio recording device, INCA®, in a community pharmacy setting: study protocol for a randomised controlled trial

Susan Mary O’Dwyer, Elaine MacHale, Imran Sulaiman, Martin Holmes, Cian Hughes, Shona D’Arcy, Viliam Rapcan, Terence Taylor, Fiona Boland, Sinthia Bosnic-Anticevich, Richard B. Reilly, Sheila A. Ryder, Richard W. Costello

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

Sharing raw data from clinical trials: what progress since we first asked “Whose data set is it anyway?”

Andrew J. Vickers

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Time-differentiated target temperature management after out-of-hospital cardiac arrest: a multicentre, randomised, parallel-group, assessor-blinded clinical trial (the TTH48 trial): study protocol for a randomised controlled trial

Hans Kirkegaard, Bodil S Rasmussen, Inge de Haas, Jørgen Feldbæk Nielsen, Susanne Ilkjær, Anne Kaltoft, Anni Nørregaard Jeppesen, Anders Grejs, Christophe Henri Valdemar Duez, Alf Inge Larsen, Ville Pettilä, Valdo Toome, Urmet Arus, Fabio Silvio Taccone, Christian Storm, Markus B. Skrifvars, Eldar Søreide

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Figure-of-eight bandage versus arm sling for treating middle-third clavicle fractures in adults: study protocol for a randomised controlled trial

Mario Lenza, Luiz Fabiano Presente Taniguchi, Mario Ferretti

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

The use of qualitative methods to inform Delphi surveys in core outcome set development

T. Keeley, P. Williamson, P. Callery, L. L. Jones, J. Mathers, J. Jones, B. Young, M. Calvert

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of the blended care self-management program “Partner in Balance” for early-stage dementia caregivers: study protocol for a randomized controlled trial

Lizzy M. M. Boots, Marjolein E. de Vugt, Gertrudis I. J. M. Kempen, Frans R. J. Verhey

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

Ethnographic methods for process evaluations of complex health behaviour interventions

Sarah Morgan-Trimmer, Fiona Wood

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial

Francesco Sofi, Monica Dinu, Giuditta Pagliai, Francesca Cesari, Rossella Marcucci, Alessandro Casini

01.12.2016 | Letter | Ausgabe 1/2016 Open Access

Sample size calculations for stepped wedge trials using design effects are only approximate in some circumstances

Karla Hemming

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Tranexamic Acid in Chronic Subdural Hematomas (TRACS): study protocol for a randomized controlled trial

Christian Iorio-Morin, Jocelyn Blanchard, Maxime Richer, David Mathieu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Activities and participation of children and adolescents after mild traumatic brain injury and the effectiveness of an early intervention (Brains Ahead!): study protocol for a cohort study with a nested randomised controlled trial

M. Irene Renaud, Suzanne A. M. Lambregts, Arend J. de Kloet, Coriene E. Catsman-Berrevoets, Ingrid G. L. van de Port, Caroline M. van Heugten

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The feasibility and acceptability of a preventive intervention programme for children with depressed parents: study protocol for a randomised controlled trial

Valeria de Angel, Fernanda Prieto, Tracy R. G. Gladstone, William R. Beardslee, Matías Irarrázaval

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial

Katharine O’Hearn, Dayre McNally, Karen Choong, Anand Acharya, Hector R. Wong, Margaret Lawson, Tim Ramsay, Lauralyn McIntyre, Elaine Gilfoyle, Marisa Tucci, David Wensley, Ronald Gottesman, Gavin Morrison, Kusum Menon, On behalf of the Canadian Critical Care Trials Group

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Clinical performance during 48 months of two current glass ionomer restorative systems with coatings: a randomized clinical trial in the field

Thomas Klinke, Amro Daboul, Anita Turek, Roland Frankenberger, Reinhard Hickel, Reiner Biffar

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

Stopping guidelines for an effectiveness trial: what should the protocol specify?

Jon E. Tyson, Claudia Pedroza, Dennis Wallace, Carl D’Angio, Edward F. Bell, Abhik Das

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial

Narayan Karunanithy, Irene Rebollo Mesa, Anthony Dorling, Francis Calder, Konstantinos Katsanos, Vikki Semik, Emily Robinson, Janet Peacock, Neelanjan Das, Colin Forman, Sarah Lawman, Kate Steiner, C Jason Wilkins, Michael G Robson

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A case study of SMART attributes: a qualitative assessment of generalizability, retention rate, and trial quality

Erica E. M. Moodie, James C. Karran, Susan M. Shortreed

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy of transcranial direct-current stimulation (tDCS) in women with provoked vestibulodynia: study protocol for a randomized controlled trial

Annie Morin, Guillaume Léonard, Véronique Gougeon, Guy Waddell, Yves-André Bureau, Isabelle Girard, Mélanie Morin

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Process-based approach to modeling recurrent-event data explicated on the basis of occurrences of tooth losses in two different prosthetic treatment concepts

Hans H. Diebner, Birgit Marré, Ingo Roeder, Michael H. Walter

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Epidermal grafting versus split-thickness skin grafting for wound healing (EPIGRAAFT): study protocol for a randomised controlled trial

Muholan Kanapathy, Nadine Hachach-Haram, Nicola Bystrzonowski, Keith Harding, Afshin Mosahebi, Toby Richards

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Electroacupuncture to treat gastroesophageal reflux disease: study protocol for a randomized controlled trial

Gajin Han, Jungtae Leem, Hojung Lee, Junhee Lee

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Perfusion Pressure Cerebral Infarct (PPCI) trial - the importance of mean arterial pressure during cardiopulmonary bypass to prevent cerebral complications after cardiac surgery: study protocol for a randomised controlled trial

Anne G. Vedel, Frederik Holmgaard, Lars Simon Rasmussen, Olaf B. Paulson, Carsten Thomsen, Else Rubæk Danielsen, Annika Langkilde, Jens P. Goetze, Theis Lange, Hanne Berg Ravn, Jens C. Nilsson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial

Wai Kun, Linda L. D. Zhong, Liang Dai, Chung-Wah Cheng, Ai-Ping Lu, Zhao-Xiang Bian

01.12.2016 | Update | Ausgabe 1/2016 Open Access

The effect of tranexamic acid on the risk of death and hysterectomy in women with post-partum haemorrhage: statistical analysis plan for the WOMAN trial

Haleema Shakur, Ian Roberts, Philip Edwards, Diana Elbourne, Zarko Alfirevic, Carine Ronsmans

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy of transcranial direct current stimulation (tDCS) in reducing consumption in patients with alcohol use disorders: study protocol for a randomized controlled trial

Benoit Trojak, Agnès Soudry-Faure, Nicolas Abello, Maud Carpentier, Lysiane Jonval, Coralie Allard, Foroogh Sabsevari, Emilie Blaise, Eddy Ponavoy, Bernard Bonin, Vincent Meille, Jean-Christophe Chauvet-Gelinier

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The evaluation of three treatments for plantar callus: a three-armed randomised, comparative trial using biophysical outcome measures

Farina Hashmi, Christopher J. Nester, Ciaran R.F. Wright, Sharon Lam

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘“FIND Technology”: investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial’

M. L. Bird, J. Cannell, M. L. Callisaya, E. Moles, A. Rathjen, K. Lane, A. Tyson, S. Smith

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Mediterranean versus vegetarian diet for cardiovascular disease prevention (the CARDIVEG study): study protocol for a randomized controlled trial’

Francesco Sofi, Monica Dinu, Giuditta Pagliai, Francesca Cesari, Rossella Marcucci, Alessandro Casini

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Type-2 diabetes primary prevention program implemented in routine primary care: a process evaluation study

Alvaro Sánchez, Carmen Silvestre, Natalia Campo, Gonzalo Grandes, on behalf of the PreDE research group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial

Christophe Rignon-Bret, Alain Hadida, Alexis Aidan, Thien-Huong Nguyen, Gerard Pasquet, Helene Fron-Chabouis, Claudine Wulfman

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial

Jiao Chen, Shuwei Feng, Jiuzhi Zeng, Xi Wu, Mingxiao Yang, Hongzhi Tang, Huaying Fan, Jie Yang, Fanrong Liang

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Digital Cognitive Behavioural Therapy for Insomnia versus sleep hygiene education: the impact of improved sleep on functional health, quality of life and psychological well-being. Study protocol for a randomised controlled trial

Colin A. Espie, Annemarie I. Luik, John Cape, Christopher L. Drake, A. Niroshan Siriwardena, Jason C. Ong, Christopher Gordon, Sophie Bostock, Peter Hames, Mhairi Nisbet, Bryony Sheaves, Russell G Foster, Daniel Freeman, Joan Costa-Font, Richard Emsley, Simon D. Kyle

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy and mechanisms of behavioral therapy components for insomnia coexisting with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial

Mary C. Kapella, James J. Herdegen, Franco Laghi, Alana D. Steffen, David W. Carley

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Chinese herbal medicine Tangshen Formula treatment of patients with type 2 diabetic kidney disease with macroalbuminuria: study protocol for a randomized controlled trial

Meihua Yan, Yumin Wen, Liping Yang, Xi’ai Wu, Xiaoguang Lu, Bingxuan Zhang, Weiping Huang, Ping Li

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (The ELAIN-Trial): study protocol for a randomized controlled trial’

Alexander Zarbock, Joachim Gerß, Hugo Van Aken, Andreea Boanta, John A. Kellum, Melanie Meersch

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Magnesium nebulization utilization in management of pediatric asthma (MagNUM PA) trial: study protocol for a randomized controlled trial

Suzanne Schuh, Judy Sweeney, Stephen B. Freedman, Allan L. Coates, David W. Johnson, Graham Thompson, Jocelyn Gravel, Francine M. Ducharme, Roger Zemek, Amy C. Plint, Darcy Beer, Terry Klassen, Sarah Curtis, Karen Black, Darcy Nicksy, Andrew R. Willan, on behalf of Pediatric Emergency Research Canada Group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Danish study of Non-Invasive testing in Coronary Artery Disease (Dan-NICAD): study protocol for a randomised controlled trial

Louise Nissen, Simon Winther, Christin Isaksen, June Anita Ejlersen, Lau Brix, Grazina Urbonaviciene, Lars Frost, Lene Helleskov Madsen, Lars Lyhne Knudsen, Samuel Emil Schmidt, Niels Ramsing Holm, Michael Maeng, Mette Nyegaard, Hans Erik Bøtker, Morten Bøttcher

01.12.2016 | Review | Ausgabe 1/2016 Open Access

A review of approaches to improve participation of culturally and linguistically diverse populations in clinical trials

Jo-anne Hughson, Robyn Woodward-Kron, Anna Parker, John Hajek, Agnese Bresin, Ute Knoch, Tuong Phan, David Story

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Building a recruitment database for asthma trials: a conceptual framework for the creation of the UK Database of Asthma Research Volunteers

Bright I. Nwaru, Ireneous N. Soyiri, Colin R. Simpson, Chris Griffiths, Aziz Sheikh

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Is a woolen cap effective in maintaining normothermia in low-birth-weight infants during kangaroo mother care? Study protocol for a randomized controlled trial

Daniele Trevisanuto, Giovanni Putoto, Damiano Pizzol, Tiziana Serena, Fabio Manenti, Silvia Varano, Eleonora Urso, William Massavon, Ademe Tsegaye, Oliver Wingi, Emanuel Onapa, Giulia Segafredo, Francesco Cavallin

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Assessment of learning curves in complex surgical interventions: a consecutive case-series study

Olympia Papachristofi, David Jenkins, Linda D. Sharples

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The role of therapeutic optimism in recruitment to a clinical trial in a peripartum setting: balancing hope and uncertainty

Nina Hallowell, Claire Snowdon, Susan Morrow, Jane E. Norman, Fiona C. Denison, Julia Lawton

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Exercise prior to assisted fertilization in overweight and obese women (FertilEX): study protocol for a randomized controlled trial

Kari Margrethe Lundgren, Liv Bente Romundstad, Vidar von Düring, Siv Mørkved, Sigrun Kjøtrød, Trine Moholdt

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Non-sedation versus sedation with a daily wake-up trial in critically ill patients recieving mechanical ventilation - effects on long-term cognitive function: Study protocol for a randomized controlled trial, a substudy of the NONSEDA trial

Helene Korvenius Nedergaard, Hanne Irene Jensen, Mette Stylsvig, Jørgen T. Lauridsen, Palle Toft

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults

Deborah A. Hall, Haula Haider, Agnieszka J. Szczepek, Pia Lau, Sarah Rabau, Julie Jones-Diette, Alain Londero, Niklas K. Edvall, Christopher R. Cederroth, Marzena Mielczarek, Thomas Fuller, Angel Batuecas-Caletrio, Petra Brueggemen, Dean M. Thompson, Arnaud Norena, Rilana F. F. Cima, Rajnikant L. Mehta, Birgit Mazurek

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial

Ary I. Savitri, Nikmah S. Idris, Wahyuni Indawati, Siti Rizny F. Saldi, Dwirani Amelia, Mohammad Baharuddin, Sudigdo Sastroasmoro, Diederick E. Grobbee, Cuno S. P. M. Uiterwaal

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes

Fowzia Ibrahim, Brian D. M. Tom, David L. Scott, Andrew Toby Prevost

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial

Ana Howarth, Linda Perkins-Porras, Jared G. Smith, Jeevakan Subramaniam, Claire Copland, Mike Hurley, Iain Beith, Muhammad Riaz, Michael Ussher

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of a medication-adherence tool: study protocol for a randomized controlled trial

Mirrian Hilbink, Joyca Lacroix, Linda Bremer - van der Heiden, Aart van Halteren, Martina Teichert, Jan van Lieshout

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The RooPfs study to assess whether improved housing provides additional protection against clinical malaria over current best practice in The Gambia: study protocol for a randomized controlled study and ancillary studies

Margaret Pinder, Lesong Conteh, David Jeffries, Caroline Jones, Jakob Knudsen, Balla Kandeh, Musa Jawara, Elisa Sicuri, Umberto D’Alessandro, Steve W. Lindsay

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Antibiotic treatment for intermittent bladder catheterisation with once daily prophylaxis (the AnTIC study): Study protocol for a randomised controlled trial

Catherine Brennand, Alexander von Wilamowitz-Moellendorff, Sarah Dunn, Jennifer Wilkinson, Thomas Chadwick, Laura Ternent, Yemi Oluboyede, Ruth Wood, Katherine Walton, Mandy Fader, James N’Dow, Mohamed Abdel-Fattah, Doreen McClurg, Paul Little, Paul Hilton, Anthony Timoney, Nicola Morris, Nikesh Thiruchelvam, James Larcombe, Simon Harrison, Heather Armstrong, Elaine McColl, Robert Pickard

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Shared care management of patients with type 2 diabetes across the primary and secondary healthcare sectors: study protocol for a randomised controlled trial

Lene Munch, Birgitte Bennich, Anne B. Arreskov, Dorthe Overgaard, Hanne Konradsen, Filip K. Knop, Tina Vilsbøll, Michael E. Røder

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Design of trials for interrupting the transmission of endemic pathogens

Mariabeth Silkey, Tobias Homan, Nicolas Maire, Alexandra Hiscox, Richard Mukabana, Willem Takken, Thomas A. Smith

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The impact of albendazole treatment on the incidence of viral- and bacterial-induced diarrhea in school children in southern Vietnam: study protocol for a randomized controlled trial

Jacqueline M. Leung, Chau Tran Thi Hong, Nghia Ho Dang Trung, Hoa Nhu Thi, Chau Nguyen Ngoc Minh, Thuy Vu Thi, Dinh Thanh Hong, Dinh Nguyen Huy Man, Sarah C. L. Knowles, Marcel Wolbers, Nhat Le Thanh Hoang, Guy Thwaites, Andrea L. Graham, Stephen Baker

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy and safety of auricular point acupressure treatment for gastrointestinal dysfunction after laparoscopic cholecystectomy: study protocol for a randomized controlled trial

Yuhua Tan, Ye Zhao, Tian He, Yueshen Ma, Wang Cai, Yandong Wang

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The efficacy and safety of Fufangdanshen tablets (Radix Salviae miltiorrhizae formula tablets) for mild to moderate vascular dementia: a study protocol for a randomized controlled trial

Jinzhou Tian, Jing Shi, Mingqing Wei, Renan Qin, Jingnian Ni, Xuekai Zhang, Ting Li, Yongyan Wang

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Recruitment of young adults for weight gain prevention: randomized comparison of direct mail strategies

Melissa M. Crane, Jessica Gokee LaRose, Mark A. Espeland, Rena R. Wing, Deborah F. Tate

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI)

Jenny L. Donovan, Leila Rooshenas, Marcus Jepson, Daisy Elliott, Julia Wade, Kerry Avery, Nicola Mills, Caroline Wilson, Sangeetha Paramasivan, Jane M. Blazeby

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The influence of a home-based exercise intervention on human health indices in individuals with chronic spinal cord injury (HOMEX-SCI): study protocol for a randomised controlled trial

Tom E. Nightingale, Jean-Philippe Walhin, James E. Turner, Dylan Thompson, James L. J. Bilzon

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial

Chetna Malhotra, David Kheng Leng Sim, Fazlur Jaufeerally, Nivedita Nadkarni Vikas, Genevieve Wong Cheng Sim, Boon Cheng Tan, Clarice Shu Hwa Ng, Pei Leng Tho, Jingfen Lim, Claire Ya-Ting Chuang, Florence Hui Mei Fong, Joy Liu, Eric A. Finkelstein

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND)

Theingi Aung, Richard Haynes, Jill Barton, Jolyon Cox, Aleksandra Murawska, Kevin Murphy, Michael Lay, Jane Armitage, Louise Bowman, ASCEND Study Collaborative Group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial

Jan Becker, Manfred E. Beutel, Katharina Gerzymisch, Dirk Schulz, Martin Siepmann, Rudolf J. Knickenberg, Stefan Schmädeke, Peter Ferdinand, Rüdiger Zwerenz

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effect of fines on nonattendance in public hospital outpatient clinics: study protocol for a randomized controlled trial

Emely Ek Blæhr, Thomas Kristensen, Ulla Væggemose, Rikke Søgaard

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement for osteoarthritis: study protocol for a randomised controlled trial

Vikki Wylde, Neil Artz, Elsa Marques, Erik Lenguerrand, Samantha Dixon, Andrew D. Beswick, Amanda Burston, James Murray, Tarique Parwez, Ashley W. Blom, Rachael Gooberman-Hill

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

An organisational change intervention for increasing the delivery of smoking cessation support in addiction treatment centres: study protocol for a randomized controlled trial

Billie Bonevski, Ashleigh Guillaumier, Anthony Shakeshaft, Michael Farrell, Flora Tzelepis, Scott Walsberger, Catherine D’Este, Chris Paul, Adrian Dunlop, Andrew Searles, Peter Kelly, Rae Fry, Robert Stirling, Carrie Fowlie, Eliza Skelton

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy and safety of Yirui capsule in patients with hyperlipidemia: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial

Liang Dai, Linda L. D. Zhong, Yan Cao, Wei Chen, Ying Cheng, Xiu-Fang Lin, Zhao-Xiang Bian, Ai-Ping Lu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial

Dinesh Neupane, Craig S. McLachlan, Bo Christensen, Arjun Karki, Henry B. Perry, Per Kallestrup

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA1- or BRCA2-mutated HER2-negative advanced breast cancer as first line treatment (REVIVAL): study protocol for a randomized controlled trial

Philip C. Schouten, Gwen M. H. E. Dackus, Serena Marchetti, Harm van Tinteren, Gabe S. Sonke, Jan H. M. Schellens, Sabine C. Linn

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Identifying the participant characteristics that predict recruitment and retention of participants to randomised controlled trials involving children: a systematic review

Louise Robinson, Pauline Adair, Margaret Coffey, Rebecca Harris, Girvan Burnside

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Vitamin D and omega-3 fatty acid supplements in children with autism spectrum disorder: a study protocol for a factorial randomised, double-blind, placebo-controlled trial

Hajar Mazahery, Cathryn Conlon, Kathryn L. Beck, Marlena C. Kruger, Welma Stonehouse, Carlos A. Camargo Jr., Barbara J. Meyer, Bobby Tsang, Owen Mugridge, Pamela R. von Hurst

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The efficacy of resveratrol in controlling hypertension: study protocol for a randomized, crossover, double-blinded, placebo-controlled trial

Ali Movahed, Afshin Ostovar, Daryoush Iranpour, Sijo Joseph Thandapilly, Pema Raj, Xavier Lieben Louis, James Michael Smoliga, Thomas Netticadan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial

Howard Ring, Nakita Gilbert, Roxanne Hook, Adam Platt, Christopher Smith, Fiona Irvine, Cam Donaldson, Elizabeth Jones, Joanna Kelly, Adrian Mander, Caroline Murphy, Mark Pennington, Angela Pullen, Marcus Redley, Simon Rowe, James Wason

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): study protocol for a randomised controlled trial

Robinson Ramírez-Vélez, Alejandra Hernandez, Karem Castro, Alejandra Tordecilla-Sanders, Katherine González-Ruíz, Jorge Enrique Correa-Bautista, Mikel Izquierdo, Antonio García-Hermoso

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial

Laura Asher, Mary De Silva, Charlotte Hanlon, Helen A. Weiss, Rahel Birhane, Dawit A. Ejigu, Girmay Medhin, Vikram Patel, Abebaw Fekadu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluating the effectiveness and cost-effectiveness of Dementia Care Mapping™ to enable person-centred care for people with dementia and their carers (DCM-EPIC) in care homes: study protocol for a randomised controlled trial

Claire A. Surr, Rebecca E. A. Walwyn, Amanda Lilley-Kelly, Robert Cicero, David Meads, Clive Ballard, Kayleigh Burton, Lynn Chenoweth, Anne Corbett, Byron Creese, Murna Downs, Amanda J. Farrin, Jane Fossey, Lucy Garrod, Elizabeth H. Graham, Alys Griffiths, Ivana Holloway, Sharon Jones, Baber Malik, Najma Siddiqi, Louise Robinson, Graham Stokes, Daphne Wallace

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Update on the endorsement of CONSORT by high impact factor journals: a survey of journal “Instructions to Authors” in 2014

Larissa Shamseer, Sally Hopewell, Douglas G. Altman, David Moher, Kenneth F. Schulz

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Study design and rationale of the ‘Balloon-Expandable Cobalt Chromium SCUBA Stent versus Self-Expandable COMPLETE-SE Nitinol Stent for the Atherosclerotic ILIAC Arterial Disease (SENS-ILIAC Trial) Trial’: study protocol for a randomized controlled trial

Woong Gil Choi, Seung Woon Rha, Cheol Ung Choi, Eung Ju Kim, Dong Joo Oh, Yoon Hyung Cho, Sang Ho Park, Seung Jin Lee, Ae Yong Hur, Young Guk Ko, Sang Min Park, Ki Chang Kim, Joo Han Kim, Min Woong Kim, Sang Min Kim, Jang Ho Bae, Jung Min Bong, Won Yu Kang, Jae Bin Seo, Woo Yong Jung, Jang Hyun Cho, Do Hoi Kim, Ji Hoon Ahn, Soo Hyun Kim, Ji Yong Jang, SENS-ILIAC Investigators

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness and cost-effectiveness of a very brief physical activity intervention delivered in NHS Health Checks (VBI Trial): study protocol for a randomised controlled trial

Joanna Mitchell, Wendy Hardeman, Sally Pears, Joana C. Vasconcelos, A. Toby Prevost, Ed Wilson, Stephen Sutton, On behalf of the VBI Research Team

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

GLP-1 analogues for neuroprotection after out-of-hospital cardiac arrest: study protocol for a randomized controlled trial

Sebastian Wiberg, Christian Hassager, Jakob Hartvig Thomsen, Martin Frydland, Dan Eik Høfsten, Thomas Engstrøm, Lars Køber, Henrik Schmidt, Jacob Eifer Møller, Jesper Kjaergaard

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial

Yuxiu Sun, Hong Zhao, Yongming Ye, Wenbin Nie, Wenjing Bai, Jia Liu, Sinuo Li, Fang Wang, Mingjuan Han, Liyun He

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy, safety, and tolerability of lacosamide in patients with gain-of-function Nav1.7 mutation-related small fiber neuropathy: study protocol of a randomized controlled trial–the LENSS study

Bianca T. A. de Greef, Ingemar S. J. Merkies, Margot Geerts, Catharina G. Faber, Janneke G. J. Hoeijmakers

01.12.2016 | Research | Ausgabe 1/2016 Open Access

What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges

Anne Daykin, Lucy E. Selman, Helen Cramer, Sharon McCann, Gillian W. Shorter, Matthew R. Sydes, Carrol Gamble, Rhiannon Macefield, J. Athene Lane, Alison Shaw

01.12.2016 | Study Protocol | Ausgabe 1/2016 Open Access

Rationale and design of the Baptist Employee Healthy Heart Study: a randomized trial assessing the efficacy of the addition of an interactive, personalized, web-based, lifestyle intervention tool to an existing health information web platform in a high-risk employee population

Janisse M. Post, Shozab S. Ali, Lara L. Roberson, Ehimen C. Aneni, Sameer Shaharyar, Adnan Younus, Omar Jamal, Rameez Ahmad, Muhammad A. Aziz, Rehan Malik, Erica S. Spatz, Theodore Feldman, Jonathan Fialkow, Emir Veledar, Ricardo C. Cury, Arthur S. Agatston, Khurram Nasir

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes

Daniel J. Bratton, Mahesh K. B. Parmar, Patrick P. J. Phillips, Babak Choodari-Oskooei

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Accounting for treatment by center interaction in sample size determinations and the use of surrogate outcomes in the pessary for the prevention of preterm birth trial: a simulation study

Andrew R. Willan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A phase II trial comparing pazopanib with doxorubicin as first-line treatment in elderly patients with metastatic or advanced soft tissue sarcoma (EPAZ): study protocol for a randomized controlled trial

Annika Karch, Armin Koch, Viktor Grünwald

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

Can “realist” randomised controlled trials be genuinely realist?

Sara Van Belle, Geoff Wong, Gill Westhorp, Mark Pearson, Nick Emmel, Ana Manzano, Bruno Marchal

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Mentalization-based treatment in groups for adolescents with borderline personality disorder (BPD) or subthreshold BPD versus treatment as usual (M-GAB): study protocol for a randomized controlled trial

Emma Beck, Sune Bo, Matthias Gondan, Stig Poulsen, Liselotte Pedersen, Jesper Pedersen, Erik Simonsen

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparison of coronary computed tomography angiography image quality with high- and low-concentration contrast agents (CONCENTRATE): study protocol for a randomized controlled trial

Dong Jin Im, Yun-Hyeon Kim, Ki Seok Choo, Joon-Won Kang, Jung Im Jung, Yoodong Won, Hyo Rim Kim, Myung Hee Chung, Kyunghwa Han, Byoung Wook Choi

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Study on Incentives for Glaucoma Medication Adherence (SIGMA): study protocol for a randomized controlled trial to increase glaucoma medication adherence using value pricing

Marcel Bilger, Tina T. Wong, Kaye L. Howard, Jia Yi Lee, Ai Nee Toh, Geraldine John, Ecosse L. Lamoureux, Eric A. Finkelstein

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Prevention of the development of psychological distress following a motor vehicle crash: study protocol for a randomized controlled trial

Rebecca Guest, Yvonne Tran, Bamini Gopinath, Ian D. Cameron, Ashley Craig

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2): study protocol for a randomised controlled trial

Thomas P. Hellyer, Niall H. Anderson, Jennie Parker, Paul Dark, Tina Van Den Broeck, Suveer Singh, Ronan McMullan, Ashley M. Agus, Lydia M. Emerson, Bronagh Blackwood, Savita Gossain, Tim S. Walsh, Gavin D. Perkins, Andrew Conway Morris, Daniel F. McAuley, A. John Simpson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparative effects of Yi Jin Jing versus Tai Chi exercise training on benign prostatic hyperplasia-related outcomes in older adults: study protocol for a randomized controlled trial

XiangYun Liu, Guoyuan Huang, Peijie Chen, Yong Li, JiuLin Xiang, Ting Chen, Ru Wang

01.12.2016 | Research | Ausgabe 1/2016 Open Access

No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals

Nicole B. Gabler, Naihua Duan, Eli Raneses, Leah Suttner, Michael Ciarametaro, Elizabeth Cooney, Robert W. Dubois, Scott D. Halpern, Richard L. Kravitz

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Biases affecting injected doses of an experimental drug during clinical trials

Nancy Perrottet, Françoise Brunner-Ferber, Eric Grouzmann, François Spertini, Jérôme Biollaz, Thierry Buclin, Nicolas Widmer

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

TSCQ study: a randomized, controlled, open-label trial of daily trimethoprim-sulfamethoxazole or weekly chloroquine among adults on antiretroviral therapy in Malawi: study protocol for a randomized controlled trial

Matthew B. Laurens, Randy G. Mungwira, Osward M. Nyirenda, Titus H. Divala, Maxwell Kanjala, Francis Muwalo, Felix A. Mkandawire, Lufina Tsirizani, Wongani Nyangulu, Edson Mwinjiwa, Terrie E. Taylor, Jane Mallewa, William C. Blackwelder, Christopher V. Plowe, Miriam K. Laufer, Joep J. van Oosterhout

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluation of differential effects of metformin treatment in obese children according to pubertal stage and genetic variations: study protocol for a randomized controlled trial

Belén Pastor-Villaescusa, Javier Caballero-Villarraso, M. Dolores Cañete, Raúl Hoyos, José Maldonado, Gloria Bueno, Rosaura Leis, Ángel Gil, Ramón Cañete, Concepción M. Aguilera

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): study protocol

Caroline Greenan, Lynn Murphy, Ly-Mee Yu, Patrick G. Kehoe, Elizabeth Coulthard, Philip Bath, Robert Stewart, Rob Jones, Anne Corbett, Alan Thomas, Peter Connelly, Frank Arrojo, Rachel Canning, Sylvia Wallach, Catherine Henderson, Bernadette McGuinness, Mike O’Sullivan, Clive Holmes, Martin Knapp, Clive Ballard, Peter Passmore, AFFECT Investigators

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Expectations, effect and experiences of an easily accessible self-management intervention for people with chronic pain: study protocol for a randomised controlled trial with embedded qualitative study

Torunn Hatlen Nøst, Aslak Steinsbekk, Ola Bratås, Kjersti Grønning

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Concurrent transcranial direct current stimulation and progressive resistance training in Parkinson’s disease: study protocol for a randomised controlled trial

Ashlee M. Hendy, Alex Tillman, Timo Rantalainen, Makii Muthalib, Liam Johnson, Dawson J. Kidgell, Daniel Wundersitz, Peter G. Enticott, Wei-Peng Teo

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Pilot Randomized trial of Fibrinogen in Trauma Haemorrhage (PRooF-iTH): study protocol for a randomized controlled trial

Jacob Steinmetz, Hanne Hee Henriksen, Anne Marie Sørensen, Theis Lange, Claus Falck Larsen, Pär I. Johansson, Jakob Stensballe

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A parenting programme to prevent abuse of adolescents in South Africa: study protocol for a randomised controlled trial

Lucie Cluver, Franziska Meinck, Yulia Shenderovich, Catherine L. Ward, Rocio Herrero Romero, Alice Redfern, Carl Lombard, Jenny Doubt, Janina Steinert, Ricardo Catanho, Camille Wittesaele, Sachin De Stone, Nasteha Salah, Phelisa Mpimpilashe, Jamie Lachman, Heidi Loening, Frances Gardner, Daphnee Blanc, Mzuvekile Nocuza, Meryn Lechowicz

01.12.2016 | Research | Ausgabe 1/2016 Open Access

“I didn’t really understand it, I just thought it’d help”: exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non-placebo clinical IMP trial

Emily Harrop, Simon Noble, Michelle Edwards, Stephanie Sivell, Barbara Moore, Annmarie Nelson, on behalf of the FRAGMATIC Trial Management Group (TMG)

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Intravenous immunoglobulin therapy for small fiber neuropathy: study protocol for a randomized controlled trial

Bianca T. A. de Greef, Margot Geerts, Janneke G. J. Hoeijmakers, Catharina G. Faber, Ingemar S. J. Merkies

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Improving treatment and liver fibrosis outcomes with metformin in HCV-HIV co-infected and HCV mono-infected patients with insulin resistance: study protocol for a randomized controlled trial

Mary-Anne Doyle, Joel Singer, Terry Lee, Miriam Muir, Curtis Cooper

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

Improving the operational efficiency of Phase 2 and 3 trials

Jitendra Ganju

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Effectiveness and cost-effectiveness of a patient-initiated botulinum toxin treatment model for blepharospasm and hemifacial spasm compared to standard care: study protocol for a randomised controlled trial’

Sadie Wickwar, Hayley McBain, Stanton P. Newman, Shashivadan P. Hirani, Catherine Hurt, Nicola Dunlop, Chris Flood, Daniel G. Ezra

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The beneficial effects of cognitive training with simple calculation and reading aloud in an elderly postsurgical population: study protocol for a randomized controlled trial

Kay Kulason, Rui Nouchi, Yasushi Hoshikawa, Masafumi Noda, Yoshinori Okada, Ryuta Kawashima

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Advantages of Bayesian monitoring methods in deciding whether and when to stop a clinical trial: an example of a neonatal cooling trial

Claudia Pedroza, Jon E. Tyson, Abhik Das, Abbot Laptook, Edward F. Bell, Seetha Shankaran, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Bayesian accrual prediction for interim review of clinical studies: open source R package and smartphone application

Yu Jiang, Peter Guarino, Shuangge Ma, Steve Simon, Matthew S. Mayo, Rama Raghavan, Byron J. Gajewski

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Kunxian capsules in the treatment of patients with ankylosing spondylitis: a randomized placebo-controlled clinical trial

Qiuxia Li, Li Li, Liqi Bi, Changhong Xiao, Zhiming Lin, Shuangyan Cao, Zetao Liao, Jieruo Gu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Valaciclovir to prevent Cytomegalovirus mediated adverse modulation of the immune system in ANCA-associated vasculitis (CANVAS): study protocol for a randomised controlled trial

Dimitrios Chanouzas, Lovesh Dyall, Peter Nightingale, Charles Ferro, Paul Moss, Matthew David Morgan, Lorraine Harper

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): study protocol for a phase III, multi-centre, double-masked randomised controlled trial

Philip J. Banerjee, Victoria R. Cornelius, Rachel Phillips, Jessica W. Lo, Catey Bunce, Joanna Kelly, Caroline Murphy, Rhiannon Tudor Edwards, Elizabeth L. Robertson, David G. Charteris

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Dietary supplementation with Bifidobacterium longum subsp. infantis (B. infantis) in healthy breastfed infants: study protocol for a randomised controlled trial

Smita Awasthi, Reason Wilken, Forum Patel, J. Bruce German, David A. Mills, Carlito B. Lebrilla, Kyoungmi Kim, Samara L. Freeman, Jennifer T. Smilowitz, April W. Armstrong, Emanual Maverakis

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Is using multiple imputation better than complete case analysis for estimating a prevalence (risk) difference in randomized controlled trials when binary outcome observations are missing?

Mavuto Mukaka, Sarah A. White, Dianne J. Terlouw, Victor Mwapasa, Linda Kalilani-Phiri, E. Brian Faragher

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluating the efficacy of dexamethasone in the treatment of patients with persistent acute respiratory distress syndrome: study protocol for a randomized controlled trial

Jesús Villar, Javier Belda, José Manuel Añón, Jesús Blanco, Lina Pérez-Méndez, Carlos Ferrando, Domingo Martínez, Juan Alfonso Soler, Alfonso Ambrós, Tomás Muñoz, Rosana Rivas, Ruth Corpas, Francisco J. Díaz-Dominguez, Marina Soro, Miguel Angel García-Bello, Rosa Lidia Fernández, Robert M. Kacmarek, the DEXA-ARDS Network

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Service-integration approaches for families with low income: a Families First Edmonton, community-based, randomized, controlled trial

Jane Drummond, Natasha Wiebe, Sylvia So, Laurie Schnirner, Jeffrey Bisanz, Deanna L. Williamson, Maria Mayan, Laura Templeton, Konrad Fassbender, for the Community-University Partnership for the Study of Children, Youth, and Families

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Trial outcomes and information for clinical decision-making: a comparative study of opinions of health professionals

Angus G. K. McNair, Sara T. Brookes, Robert N. Whistance, Rachael O. Forsythe, Rhiannon Macefield, Jonathan Rees, James Jones, George Smith, Anne M. Pullyblank, Kerry N. L. Avery, Michael G. Thomas, Paul A. Sylvester, Anne Russell, Alfred Oliver, Dion Morton, Robin Kennedy, David G. Jayne, Richard Huxtable, Rowland Hackett, Susan J. Dutton, Mark G. Coleman, Mia Card, Julia Brown, Jane M. Blazeby, On behalf of the CONSENSUS-CRC (Core Outcomes and iNformation SEts iN SUrgical Studies – ColoRectal Cancer) working group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial

Ivo N. van Schaik, Nan van Geloven, Vera Bril, Hans-Peter Hartung, Richard A. Lewis, Gen Sobue, John-Philip Lawo, Orell Mielke, David R. Cornblath, Ingemar S. J. Merkies, on behalf of the PATH study group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The combination effects of body acupuncture and auricular acupressure compared to sham acupuncture for body weight control: study protocol for a randomized controlled trial

Linda L. D. Zhong, Wai Kun, Tsz Fung Lam, Shi Ping Zhang, Jun Jun Yang, Tat Chi Ziea, Bacon Ng, Zhao Xiang Bian

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of prebiotic intake on gut microbiota, intestinal permeability and glycemic control in children with type 1 diabetes: study protocol for a randomized controlled trial

Josephine Ho, Raylene A. Reimer, Manpreet Doulla, Carol Huang

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Varied flushing frequency and volume to prevent peripheral intravenous catheter failure: a pilot, factorial randomised controlled trial in adult medical-surgical hospital patients

Samantha Keogh, Julie Flynn, Nicole Marsh, Gabor Mihala, Karen Davies, Claire Rickard

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The Sources of Strength Australia Project: study protocol for a cluster randomised controlled trial

Alison L. Calear, Jacqueline L. Brewer, Philip J. Batterham, Andrew Mackinnon, Peter A. Wyman, Mark LoMurray, Fiona Shand, Dominique Kazan, Helen Christensen

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy in patients without systemic sedation: results of a single-center, double-blinded, randomized controlled trial (DRKS00000164)

Anja Schaible, Katja Schwan, Thomas Bruckner, Konstanze Plaschke, Markus W. Büchler, Markus Weigand, Peter Sauer, Christian Bopp, Phillip Knebel

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Guided self-help cognitive behavioral intervention for VoicEs (GiVE): study protocol for a pilot randomized controlled trial

Cassie M. Hazell, Mark Hayward, Kate Cavanagh, Anna-Marie Jones, Clara Strauss

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Guided Internet-delivered cognitive behavioural therapy in patients with non-cardiac chest pain – a pilot randomized controlled study

Ghassan Mourad, Anna Strömberg, Egil Jonsbu, Mikael Gustafsson, Peter Johansson, Tiny Jaarsma

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Vitamin D intervention in preschoolers with viral-induced asthma (DIVA): a pilot randomised controlled trial

Megan E. Jensen, Genevieve Mailhot, Nathalie Alos, Elizabeth Rousseau, John H. White, Ali Khamessan, Francine M. Ducharme

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial

Jie-shu You, Jian-ping Chen, Jessie S.M. Chan, Ho-fun Lee, Mei-kuen Wong, Wing-Fai Yeung, Li-xing Lao

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Motivating smokers at outdoor public smoking hotspots to have a quit attempt with a nicotine replacement therapy sample: study protocol for a randomized controlled trial

Yee Tak Derek Cheung, Jessica Pui Kei Leung, Chelsia Ka Ching Cheung, William Ho Cheung Li, Man Ping Wang, Tai Hing Lam

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Mass mosquito trapping for malaria control in western Kenya: study protocol for a stepped wedge cluster-randomised trial

Alexandra Hiscox, Tobias Homan, Collins K. Mweresa, Nicolas Maire, Aurelio Di Pasquale, Daniel Masiga, Prisca A. Oria, Jane Alaii, Cees Leeuwis, Wolfgang R. Mukabana, Willem Takken, Thomas A. Smith

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: 'Chinese medicine combined with calcipotriol betamethasone and calcipotriol ointment for Psoriasis vulgaris (CMCBCOP): study protocol for a randomized controlled trial'

Ze-Huai Wen, Mei-Ling Xuan, Yu-Hong Yan, Xiao-Yan Li, Dan-Ni Yao, Geng Li, Xin-Feng Guo, Ai-Hua Ou, Chuan-Jian Lu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Standardised Chinese herbal treatment delivered by GPs compared with individualised treatment administered by practitioners of Chinese herbal medicine for women with recurrent urinary tract infections (RUTI): study protocol for a randomised controlled trial

Andrew Flower, Kim Harman, George Lewith, Michael Moore, Felicity L. Bishop, Beth Stuart, Nicholas Lampert

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Tong Luo Hua Shi capsule, a modernized Tibetan medicine, in patients with rheumatoid arthritis

Wei Liu, Yuan-Hao Wu, Si-Yuan Hu, Cheng-Liang Zhong, Ming-Li Gao, Dong-Wu Liu, Hai-Yun Wang, Mu-Zhi Chen, Yue-Jin Song, Ben-Zha-Xi Yang, Qing-Shan Zheng, Hua Yao, Xue-Bing Qi, Gang Li

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Development of a core outcome set for use in determining the overall success of gastroschisis treatment

Benjamin Allin, Andrew Ross, Sean Marven, Nigel J Hall, Marian Knight

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A phase I, placebo-controlled, randomized, double-blind, single ascending dose-ranging study to evaluate the safety and tolerability of a novel biophysical bronchodilator (S-1226) administered by nebulization in healthy volunteers

Francis H. Y. Green, Richard Leigh, Morenike Fadayomi, Gurkeet Lalli, Andrea Chiu, Grishma Shrestha, Sharif G. ElShahat, David Evan Nelson, Tamer Y. El Mays, Cora A. Pieron, John H. Dennis

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Coping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: study protocol for two randomised controlled trials

Alexandra C. De Young, Ann-Christin Haag, Justin A. Kenardy, Roy M. Kimble, Markus A. Landolt

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Promoting weight loss through diet and exercise in overweight or obese breast cancer survivors (InForma): study protocol for a randomized controlled trial

Patrizia Gnagnarella, Daniele Dragà, Federica Baggi, Maria Claudia Simoncini, Annarita Sabbatini, Ketti Mazzocco, Fabio Domenico Bassi, Gabriella Pravettoni, Patrick Maisonneuve

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The experience of adolescents participating in a randomised clinical trial in the field of mental health: a qualitative study

Nick Midgley, Danny Isaacs, Katharina Weitkamp, Mary Target

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Recruiting faith- and non-faith-based schools, adolescents and parents to a cluster randomised sexual-health trial: experiences, challenges and lessons from the mixed-methods Jack Feasibility Trial

Áine Aventin, Maria Lohan, Lisa Maguire, Mike Clarke

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Hepatitis C – Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial

Kirsty Roberts, John Macleod, Chris Metcalfe, Joanne Simon, Jeremy Horwood, William Hollingworth, Sharon Marlowe, Fiona H. Gordon, Peter Muir, Barbara Coleman, Peter Vickerman, Graham I. Harrison, Cherry-Ann Waldron, William Irving, Matthew Hickman

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Happy Family Kitchen II: a cluster randomized controlled trial of a community-based positive psychology family intervention for subjective happiness and health-related quality of life in Hong Kong

Henry C. Y. Ho, Moses Mui, Alice Wan, Yin-lam Ng, Sunita M. Stewart, Carol Yew, Tai Hing Lam, Sophia S. Chan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of lifestyle intervention in BRCA1/2 mutation carriers on nutrition, BMI, and physical fitness (LIBRE study): study protocol for a randomized controlled trial

Marion Kiechle, Christoph Engel, Anika Berling, Katrin Hebestreit, Stephan C. Bischoff, Ricarda Dukatz, Michael Siniatchkin, Katharina Pfeifer, Sabine Grill, Maryam Yahiaoui-Doktor, Ellen Kirsch, Uwe Niederberger, Ute Enders, Markus Löffler, Alfons Meindl, Kerstin Rhiem, Rita Schmutzler, Nicole Erickson, Martin Halle

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy of ultra-micronized palmitoylethanolamide (um-PEA) in geriatric patients with chronic pain: study protocol for a series of N-of-1 randomized trials

Maura Marcucci, Federico Germini, Anna Coerezza, Luca Andreinetti, Lorenzo Bellintani, Alessandro Nobili, Paolo Dionigi Rossi, Daniela Mari

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Towards onset prevention of cognition decline in adults with Down syndrome (The TOP-COG study): A pilot randomised controlled trial

Sally-Ann Cooper, Temitope Ademola, Muriel Caslake, Elizabeth Douglas, Jonathan Evans, Nicola Greenlaw, Caroline Haig, Angela Hassiotis, Andrew Jahoda, Alex McConnachie, Jill Morrison, Howard Ring, John Starr, Ciara Stiles, Chammy Sirisena, Frank Sullivan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The Cognitive Remediation in Bipolar (CRiB) pilot study: study protocol for a randomised controlled trial

Rebecca Strawbridge, Jessica Fish, Rozmin Halari, John Hodsoll, Clare Reeder, Karine Macritchie, Paul McCrone, Til Wykes, Allan H. Young

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial

Itxaso González-Ortega, Enrique Echeburúa, Adriana García-Alocén, Patricia Vega, Ana González-Pinto

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project

William J. Meurer, Laurie Legocki, Samkeliso Mawocha, Shirley M. Frederiksen, Timothy C. Guetterman, William Barsan, Roger Lewis, Donald Berry, Michael Fetters

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Randomized controlled trials: who fails run-in?

Judy R. Rees, Leila A. Mott, Elizabeth L. Barry, John A. Baron, Jane C. Figueiredo, Douglas J. Robertson, Robert S. Bresalier, Janet L. Peacock

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Melatonin in Youth: N-of-1 trials in a stimulant-treated ADHD Population (MYNAP): study protocol for a randomized controlled trial

Salima Punja, Catherine J. Nikles, Hugh Senior, Geoffrey Mitchell, Christopher H. Schmid, Helen Heussler, Manisha Witmans, Sunita Vohra

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies

Annabelle South, Bec Hanley, Mitzy Gafos, Ben Cromarty, Richard Stephens, Kate Sturgeon, Karen Scott, William J. Cragg, Conor D. Tweed, Jacqueline Teera, Claire L. Vale

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial—PROSPECT: a pilot trial

Deborah J. Cook, Jennie Johnstone, John C. Marshall, Francois Lauzier, Lehana Thabane, Sangeeta Mehta, Peter M. Dodek, Lauralyn McIntyre, Joe Pagliarello, William Henderson, Robert W. Taylor, Rodrigo Cartin-Ceba, Eyal Golan, Margaret Herridge, Gordon Wood, Daniel Ovakim, Tim Karachi, Michael G. Surette, Dawn M. E. Bowdish, Daphnee Lamarche, Chris P. Verschoor, Erick H. Duan, Diane Heels-Ansdell, Yaseen Arabi, Maureen Meade, For the PROSPECT Investigators and the Canadian Critical Care Trials Group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Endothelial Dysfunction in Resuscitated Cardiac Arrest (ENDO-RCA): safety and efficacy of low-dose prostacyclin administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac arrest syndrome patients: study protocol for a randomized controlled trial

Anna Sina P. Meyer, Sisse R. Ostrowski, Jesper Kjaergaard, Pär I. Johansson, Christian Hassager

01.12.2016 | Update | Ausgabe 1/2016 Open Access

Statistical analysis plan for the PlAtelet Transfusion in Cerebral Haemorrhage (PATCH) trial: a multicentre randomised controlled trial

M. Irem Baharoglu, Rustam Al-Shahi Salman, Charlotte Cordonnier, Rob J. de Haan, Yvo B. W. E. M. Roos

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Transcranial direct current stimulation in post-stroke sub-acute aphasia: study protocol for a randomized controlled trial

Kerstin Spielmann, W. Mieke E. van de Sandt-Koenderman, Majanka H. Heijenbrok-Kal, Gerard M. Ribbers

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Exercise strategies to protect against the impact of short-term reduced physical activity on muscle function and markers of health in older men: study protocol for a randomised controlled trial

Oliver J. Perkin, Rebecca L. Travers, Javier T. Gonzalez, James E. Turner, Fiona Gillison, Cassie Wilson, Polly M. McGuigan, Dylan Thompson, Keith A. Stokes

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial

Simone Regina Posser, Carine Cristina Callegaro, Marina Beltrami-Moreira, Leila Beltrami Moreira

01.12.2016 | Update | Ausgabe 1/2016 Open Access

A phase III, multi-centre, double-masked randomised controlled trial of adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): statistical analysis plan

Jessica W. Lo, Catey Bunce, David Charteris, Philip Banerjee, Rachel Phillips, Victoria R. Cornelius

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Targeted tissue perfusion versus macrocirculation-guided standard care in patients with septic shock (TARTARE-2S): study protocol and statistical analysis plan for a randomized controlled trial

Ville Pettilä, Tobias Merz, Erika Wilkman, Anders Perner, Sari Karlsson, Theis Lange, Johanna Hästbacka, Peter Buhl Hjortrup, Anne Kuitunen, Stephan M. Jakob, Jukka Takala

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A single-blind, dose escalation, phase I study of high-fluence light-emitting diode-red light (LED-RL) on human skin: study protocol for a randomized controlled trial

Derek Ho, Ekaterina Kraeva, Ted Wun, R. Rivkah Isseroff, Jared Jagdeo

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A process evaluation of a cluster randomised trial to reduce potentially inappropriate prescribing in older people in primary care (OPTI-SCRIPT study)

Barbara Clyne, Janine A. Cooper, Carmel M. Hughes, Tom Fahey, Susan M. Smith, on behalf of the OPTI-SCRIPT study team

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries

Annet Kleiboer, Jan Smit, Judith Bosmans, Jeroen Ruwaard, Gerhard Andersson, Naira Topooco, Thomas Berger, Tobias Krieger, Cristina Botella, Rosa Baños, Karine Chevreul, Ricardo Araya, Arlinda Cerga-Pashoja, Roman Cieślak, Anna Rogala, Christiaan Vis, Stasja Draisma, Anneke van Schaik, Lise Kemmeren, David Ebert, Matthias Berking, Burkhardt Funk, Pim Cuijpers, Heleen Riper

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Cool Runnings – an app-based intervention for reducing hot drink scalds: study protocol for a randomised controlled trial

J. D. Burgess, C. M. Cameron, K. Watt, R. M. Kimble

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Treatment with l-citrulline and metformin in Duchenne muscular dystrophy: study protocol for a single-centre, randomised, placebo-controlled trial

Patricia Hafner, Ulrike Bonati, Daniela Rubino, Vanya Gocheva, Thomas Zumbrunn, Nuri Gueven, Dirk Fischer

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial

Yaseen M Arabi, Sami Alsolamy, Abdulaziz Al-Dawood, Awad Al-Omari, Fahad Al-Hameed, Karen E. A. Burns, Mohammed Almaani, Hani Lababidi, Ali Al Bshabshe, Sangeeta Mehta, Abdulsalam M. Al-Aithan, Yasser Mandourah, Ghaleb Almekhlafi, Simon Finfer, Sheryl Ann I. Abdukahil, Lara Y. Afesh, Maamoun Dbsawy, Musharaf Sadat

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of medication timing on anticoagulation stability in users of warfarin (the INRange RCT): study protocol for a randomized controlled trial

Balraj S. Heran, G. Michael Allan, Lee Green, Christina Korownyk, Michael Kolber, Nicole Olivier, Mary Flesher, Scott Garrison

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The efficacy of Cognitive training in patients with VAsCular Cognitive Impairment, No dEmentia (the Cog-VACCINE study): study protocol for a randomized controlled trial

Yi Tang, Zude Zhu, Qing Liu, Fang Li, Jianwei Yang, Fangyu Li, Yi Xing, Jianping Jia

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A school-based health promotion programme to increase help-seeking for substance use and mental health problems: study protocol for a randomised controlled trial

Dan I. Lubman, Bonita J. Berridge, Fiona Blee, Anthony F. Jorm, Coralie J. Wilson, Nicholas B. Allen, Lisa McKay-Brown, Jenny Proimos, Ali Cheetham, Rory Wolfe

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

ACEMg-mediated hearing preservation in cochlear implant patients receiving different electrode lengths (PROHEARING): study protocol for a randomized controlled trial

Verena Scheper, Melanie Leifholz, Heiko von der Leyen, Miriam Keller, Ute Denkena, Armin Koch, Annika Karch, Josef Miller, Thomas Lenarz

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The Post-Anaesthesia N-acetylcysteine Cognitive Evaluation (PANACEA) trial: study protocol for a randomised controlled trial

David R. Skvarc, Olivia M. Dean, Linda K. Byrne, Laura J. Gray, Kathryn Ives, Stephen E. Lane, Matthew Lewis, Cameron Osborne, Richard Page, Douglas Stupart, Alyna Turner, Michael Berk, Andrew J. Marriott

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

The role of qualitative research in adding value to a randomised controlled trial: lessons from a pilot study of a guided e-learning intervention for managers to improve employee wellbeing and reduce sickness absence

Jill Russell, Lee Berney, Stephen Stansfeld, Doris Lanz, Sally Kerry, Tarani Chandola, Kamaldeep Bhui

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Counteracting Age-related Loss of Skeletal Muscle Mass: a clinical and ethnological trial on the role of protein supplementation and training load (CALM Intervention Study): study protocol for a randomized controlled trial

Rasmus Leidesdorff Bechshøft, Søren Reitelseder, Grith Højfeldt, Josué Leonardo Castro-Mejía, Bekzod Khakimov, Hajar Fauzan Bin Ahmad, Michael Kjær, Søren Balling Engelsen, Susanne Margrete Bølling Johansen, Morten Arendt Rasmussen, Aske Juul Lassen, Tenna Jensen, Nina Beyer, Anja Serena, Frederico Jose Armando Perez-Cueto, Dennis Sandris Nielsen, Astrid Pernille Jespersen, Lars Holm

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The use of everolimus in the treatment of neurocognitive problems in tuberous sclerosis (TRON): study protocol for a randomised controlled trial

Elizabeth Randell, Rachel McNamara, D. Mark Davies, Eleri Owen-Jones, Nigel Kirby, Lianna Angel, Cheney Drew, Rebecca Cannings-John, Michelle Smalley, Anurag Saxena, Emer McDermott, Laura Stockwell, Petrus J. de Vries, Kerry Hood, Julian R. Sampson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The preventative role of exogenous melatonin administration to patients with advanced cancer who are at risk of delirium: study protocol for a randomized controlled trial

Shirley Harvey Bush, Nathalie Lacaze-Masmonteil, Marie Theresa McNamara-Kilian, Alistair Richard MacDonald, Sallyanne Tierney, Franco Momoli, Meera Agar, David Christopher Currow, Peter Gerard Lawlor

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Opportunities and challenges in incorporating ancillary studies into a cancer prevention randomized clinical trial

Phyllis J. Goodman, Catherine M. Tangen, Amy K. Darke, Kathryn B. Arnold, JoAnn Hartline, Monica Yee, Karen Anderson, Allison Caban-Holt, William G. Christen, Patricia A. Cassano, Peter Lance, Eric A. Klein, John J. Crowley, Lori M. Minasian, Frank L. Meyskens

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Standardised Outcomes in Nephrology—Children and Adolescents (SONG-Kids): a protocol for establishing a core outcome set for children with chronic kidney disease

Allison Tong, Susan Samuel, Michael Zappitelli, Allison Dart, Susan Furth, Allison Eddy, Jaap Groothoff, Nicholas J. A. Webb, Hui-Kim Yap, Detlef Bockenhauer, Aditi Sinha, Stephen I. Alexander, Stuart L. Goldstein, Debbie S. Gipson, Camilla S. Hanson, Nicole Evangelidis, Sally Crowe, Tess Harris, Brenda R. Hemmelgarn, Braden Manns, John Gill, Peter Tugwell, Wim Van Biesen, David C. Wheeler, Wolfgang C. Winkelmayer, Jonathan C. Craig, on behalf of the SONG-Kids Investigators

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Intra-cluster and inter-period correlation coefficients for cross-sectional cluster randomised controlled trials for type-2 diabetes in UK primary care

James Martin, Alan Girling, Krishnarajah Nirantharakumar, Ronan Ryan, Tom Marshall, Karla Hemming

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of early, combined endurance and resistance training in mechanically ventilated, critically ill patients: a study protocol for a randomised controlled trial

Sabrina Eggmann, Martin L. Verra, Gere Luder, Jukka Takala, Stephan M. Jakob

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial

Cyril Villat, Jean-Pierre Attal, Nathalie Brulat, Franck Decup, Sophie Doméjean, Elisabeth Dursun, Hélène Fron-Chabouis, Bruno Jacquot, Michèle Muller Bolla, Nelly Plasse-Pradelle, Laurent Roche, Delphine Maucort-Boulch, Patrice Nony, Kerstin Gritsch, Pierre Millet, François Gueyffier, Brigitte Grosgogeat

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Transcranial direct current stimulation combined with upper limb functional training in children with spastic, hemiparetic cerebral palsy: study protocol for a randomized controlled trial

Renata Calhes Franco Moura, Cibele Almeida Santos, Luanda André Collange Grecco, Roberta Delasta Lazzari, Arislander Jonathan Lopes Dumont, Natalia Carvalho de Almeida Duarte, Luiz Alfredo Braun, Jamile Benite Palma Lopes, Ligia Abram dos Santos, Eliane Lopes Souza Rodrigues, Giorgio Albertini, Veronica Cimolin, Manuela Galli, Claudia Santos Oliveira

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice

Cylie M. Williams, Elizabeth H. Skinner, Alicia M. James, Jill L. Cook, Steven M. McPhail, Terry P. Haines

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

One-layer versus two-layer duct-to-mucosa pancreaticojejunostomy after pancreaticoduodenectomy: study protocol for a randomized controlled trial

Shu-bo Pan, Wei Geng, Da-chen Zhou, Jiang-ming Chen, Hong-chuan Zhao, Fu-bao Liu, Sheng-xue Xie, Hui Hou, Yi-jun Zhao, Kun Xie, Guo-bin Wang, Xiao-ping Geng

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A randomized double-blind controlled trial of the use of dydrogesterone in women with threatened miscarriage in the first trimester: study protocol for a randomized controlled trial

Diana Man Ka Chan, Ka Wang Cheung, Sofie Shuk Fei Yung, Vivian Chi Yan Lee, Raymond Hang Wun Li, Ernest Hung Yu Ng

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Three nested randomized controlled trials of peer-only or multiple stakeholder group feedback within Delphi surveys during core outcome and information set development

Sara T. Brookes, Rhiannon C. Macefield, Paula R. Williamson, Angus G. McNair, Shelley Potter, Natalie S. Blencowe, Sean Strong, Jane M. Blazeby

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Modafinil In Debilitating fatigue After Stroke (MIDAS): study protocol for a randomised, double-blinded, placebo-controlled, crossover trial

Thomas Lillicrap, Venkatesh Krishnamurthy, John Attia, Michael Nilsson, Christopher R. Levi, Mark W. Parsons, Andrew Bivard

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Stability of Unicortical versus Bicortical Metacarpal Fracture Internal Fixation Trial (SUBMIT): study protocol for a randomized controlled trial

Feiran Wu, Katie Young, Mohammad Shahid, Peter Nightingale, Surabhi Choudhary, Michael Craigen, Rajive Jose, Mark Foster

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of Xinyue capsules on patients with coronary heart disease after percutaneous coronary intervention: study protocol for a randomized controlled trial

Ming Guo, Ming-jie Zi, Rui-xi Xi, Qiao-ning Yang, Rui-na Bai, Yi-sheng Zhang, Yu-hua Wang, Pei-li Wang, Da-zhuo Shi

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of a high-intensity interval training program versus a moderate-intensity continuous training program on maximal oxygen uptake and blood pressure in healthy adults: study protocol for a randomized controlled trial

Víctor Hugo Arboleda Serna, Elkin Fernando Arango Vélez, Rubén Darío Gómez Arias, Yuri Feito

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy of a new technique – INtubate-RECruit-SURfactant-Extubate – “IN-REC-SUR-E” – in preterm neonates with respiratory distress syndrome: study protocol for a randomized controlled trial

Giovanni Vento, Roberta Pastorino, Luca Boni, Francesco Cota, Virgilio Carnielli, Filip Cools, Carlo Dani, Fabio Mosca, Jane Pillow, Graeme Polglase, Paolo Tagliabue, Anton H. van Kaam, Maria Luisa Ventura, Milena Tana, Chiara Tirone, Claudia Aurilia, Alessandra Lio, Cinzia Ricci, Alessandro Gambacorta, Chiara Consigli, Danila D’Onofrio, Camilla Gizzi, Luca Massenzi, Viviana Cardilli, Alessandra Casati, Roberto Bottino, Federica Pontiggia, Elena Ciarmoli, Stefano Martinelli, Laura Ilardi, Mariarosa Colnaghi, Piero Giuseppe Matassa, Valentina Vendettuoli, Paolo Villani, Francesca Fusco, Diego Gazzolo, Alberto Ricotti, Federica Ferrero, Ilaria Stasi, Rosario Magaldi, Gianfranco Maffei, Giuseppe Presta, Roberto Perniola, Francesco Messina, Giovanna Montesano, Chiara Poggi, Lucio Giordano, Enza Roma, Carolina Grassia, Gaetano Ausanio, Fabrizio Sandri, Giovanna Mescoli, Francesco Giura, Giampaolo Garani, Agostina Solinas, Maria Lucente, Gabriella Nigro, Antonello Del Vecchio, Flavia Petrillo, Luigi Orfeo, Lidia Grappone, Lorenzo Quartulli, Antonio Scorrano, Hubert Messner, Alex Staffler, Giancarlo Gargano, Eleonora Balestri, Stefano Nobile, Caterina Cacace, Valerio Meli, Sara Dallaglio, Betta Pasqua, Loretta Mattia, Eloisa Gitto, Marcello Vitaliti, Maria Paola Re, Stefania Vedovato, Alessandra Grison, Alberto Berardi, Francesco Torcetta, Isotta Guidotti, Sandra di Fabio, Eugenia Maranella, Isabella Mondello, Stefano Visentin, Francesca Tormena

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Baclofen to prevent agitation in alcohol-addicted patients in the ICU: study protocol for a randomised controlled trial

Mickael Vourc’h, Fanny Feuillet, Pierre-Joachim Mahe, Véronique Sebille, Karim Asehnoune, The BACLOREA trial group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Using discrete choice experiments as a decision aid in total knee arthroplasty: study protocol for a randomised controlled trial

Michelle M. Dowsey, Anthony Scott, Elizabeth A. Nelson, Jinhu Li, Vijaya Sundararajan, Mandana Nikpour, Peter F. M. Choong

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial

Joanne Wilcox, Chantelle Waite, Lyndsey Tomlinson, Joanne Driscoll, Asra Karim, Edward Day, Adnan Sharif

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluation of the anti-fatigue effects of a traditional herbal drug, Gongjin-dan, under insufficient sleep conditions: study protocol for a randomised controlled trial

Mi Ju Son, Hwi-Jin Im, Young-Eun Kim, Boncho Ku, Jun-Hwan Lee, Chang-Gue Son

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Stakeholders’ views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs

Shona Kalkman, Ghislaine J. M. W. van Thiel, Diederick E. Grobbee, Anna-Katharina Meinecke, Mira G. P. Zuidgeest, Johannes J. M. van Delden, on behalf of Work Package 3 of the IMI GetReal Consortium

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial

Yaseen M. Arabi, Sami Alsolamy, Abdulaziz Al-Dawood, Awad Al-Omari, Fahad Al-Hameed, Karen E. A. Burns, Mohammed Almaani, Hani Lababidi, Ali Al Bshabshe, Sangeeta Mehta, Abdulsalam M. Al-Aithan, Yasser Mandourah, Ghaleb Almekhlafi, Simon Finfer, Sheryl Ann I. Abdukahil, Lara Y. Afesh, Maamoun Dbsawy, Musharaf Sadat

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Endovenous laser ablation versus mechanochemical ablation with ClariVein® in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial

Clement C. M. Leung, Daniel Carradice, Tom Wallace, Ian C. Chetter

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluation of the vascular protective effects of new oral anticoagulants in high-risk patients with atrial fibrillation (PREFER-AF): study protocol for a randomized controlled trial

Jin-Bae Kim, Hyun Jun Joung, Jung Myung Lee, Jong Shin Woo, Woo-shik Kim, Kwon Sam Kim, Kyung Hye Lee, Weon Kim

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The impact of long-lasting microbial larvicides in reducing malaria transmission and clinical malaria incidence: study protocol for a cluster randomized controlled trial

Guofa Zhou, Virginia Wiseman, Harrysone E. Atieli, Ming-Chieh Lee, Andrew K. Githeko, Guiyun Yan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial

Peter A. Coventry, Peter Bower, Amy Blakemore, Liz Baker, Mark Hann, Angela Paisley, Charlotte Renwick, Jinshuo Li, Atushi Ugajin, Martin Gibson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Walking adaptability therapy after stroke: study protocol for a randomized controlled trial

Celine Timmermans, Melvyn Roerdink, Marielle W. van Ooijen, Carel G. Meskers, Thomas W. Janssen, Peter J. Beek

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Representativeness of the participants in the smoking Cessation in Pregnancy Incentives Trial (CPIT): a cross-sectional study

Barnabas Bessing, Linda Bauld, Lesley Sinclair, Daniel F. Mackay, William Spence, David M. Tappin

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Family psychoeducation for major depressive disorder – study protocol for a randomized controlled trial

Nina Timmerby, Stephen F. Austin, Kristian Ussing, Per Bech, Claudio Csillag

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization

Alexandra R. Brown, Byron J. Gajewski, Lauren S. Aaronson, Dinesh Pal Mudaranthakam, Suzanne L. Hunt, Scott M. Berry, Melanie Quintana, Mamatha Pasnoor, Mazen M. Dimachkie, Omar Jawdat, Laura Herbelin, Richard J. Barohn

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Development of a core outcome set for clinical trials in rosacea: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Sanjana Iyengar, Paula R. Williamson, Jochen Schmitt, Lena Johannsen, Ian A. Maher, Joseph F. Sobanko, Todd V. Cartee, Daniel Schlessinger, Emily Poon, Murad Alam

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish

Paola Rosati, Franz Porzsolt, Gabriella Ricciotti, Giuseppina Testa, Rita Inglese, Ferruccio Giustini, Ersilia Fiscarelli, Marco Zazza, Cecilia Carlino, Valerio Balassone, Roberto Fiorito, Roberto D’Amico

01.12.2016 | Research | Ausgabe 1/2016 Open Access

How informed is declared altruism in clinical trials? A qualitative interview study of patient decision-making about the QUEST trials (Quality of Life after Mastectomy and Breast Reconstruction)

Natalie Bidad, Lindsay MacDonald, Zoë E. Winters, Sarah J. L. Edwards, Marie Emson, Clare L. Griffin, Judith Bliss, Rob Horne

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluation of low-level laser at auriculotherapy points to reduce postoperative pain in inferior third molar surgery: study protocol for a randomized controlled trial

Hélio Sampaio-Filho, Juliane Sotto-Ramos, Erika Horácio Pinto, Marcia Regina Cabral, Priscila Larcher Longo, Isabel Peixoto Tortamano, Rodrigo Labat Marcos, Daniela Fátima Teixeira Silva, Christine Pavani, Anna Carolina Ratto Tempestini Horliana

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of physical exercise training in patients with Chagas heart disease: study protocol for a randomized controlled trial (PEACH study)

Fernanda de Souza Nogueira Sardinha Mendes, Andréa Silvestre Sousa, Fernando Cesar de Castro Cesar Souza, Vivian Liane Mattos Pinto, Paula Simplicio Silva, Roberto Magalhães Saraiva, Sergio Salles Xavier, Henrique Horta Veloso, Marcelo Teixeira Holanda, Andréa Rodrigues Costa, Fernanda Martins Carneiro, Gilberto Marcelo Sperandio Silva, Juliana Pereira Borges, Eduardo Tibirica, Roberta Olmo Pinheiro, Flávio Alves Lara, Alejandro Marcel Hasslocher-Moreno, Pedro Emmanuel Alvarenga Americano Brasil, Mauro Felippe Felix Mediano

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Practice facilitation for improving cardiovascular care: secondary evaluation of a stepped wedge cluster randomized controlled trial using population-based administrative data

Catherine Deri Armstrong, Monica Taljaard, William Hogg, Amy E. Mark, Clare Liddy

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

EMBalance - validation of a decision support system in the early diagnostic evaluation and management plan formulation of balance disorders in primary care: study protocol of a feasibility randomised controlled trial

Laura Rammazzo, Dimitris Kikidis, Amal Anwer, Nora Macdonald, Efthymios Kyrodimos, Christoph Maurer, Floris Wuyts, Linda Luxon, Athanasios Bibas, Doris-Eva Bamiou

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Phone-based Intervention under Nurse Guidance after Stroke (PINGS): study protocol for a randomized controlled trial

Fred Stephen Sarfo, Frank Treiber, Carolyn Jenkins, Sachin Patel, Mulugeta Gebregziabher, Arti Singh, Osei Sarfo-Kantanka, Raelle Saulson, Lambert Appiah, Eunice Oparebea, Bruce Ovbiagele

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of polymorphisms in the CD36 and STAT3 genes on different dietary interventions among patients with coronary artery disease: study protocol for a randomized controlled trial

Vera Lucia Portal, Melissa Medeiros Markoski, Alexandre Schaan de Quadros, Sílvia Garofallo, Julia Lorenzon dos Santos, Aline Oliveira, Camila Wechenfelder, Viviane Paiva de Campos, Priscilla Azambuja Lopes de Souza, Luana Machado, Aline Marcadenti

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Increased risk of type I errors in cluster randomised trials with small or medium numbers of clusters: a review, reanalysis, and simulation study

Brennan C. Kahan, Gordon Forbes, Yunus Ali, Vipul Jairath, Stephen Bremner, Michael O. Harhay, Richard Hooper, Neil Wright, Sandra M. Eldridge, Clémence Leyrat

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The impact of a knowledge translation intervention employing educational outreach and a point-of-care reminder tool vs standard lay health worker training on tuberculosis treatment completion rates: study protocol for a cluster randomized controlled trial

Lisa M. Puchalski Ritchie, Monique van Lettow, Austine Makwakwa, Adrienne K. Chan, Jemila S. Hamid, Harry Kawonga, Alexandra L. C. Martiniuk, Michael J. Schull, Vanessa van Schoor, Merrick Zwarenstein, Jan Barnsley, Sharon E. Straus

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Models and impact of patient and public involvement in studies carried out by the Medical Research Council Clinical Trials Unit at University College London: findings from ten case studies’

Annabelle South, Bec Hanley, Mitzy Gafos, Ben Cromarty, Richard Stephens, Kate Sturgeon, Karen Scott, William J. Cragg, Conor D. Tweed, Jacqueline Teera, Claire L. Vale

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial

Cathryn Glazener, Lynda Constable, Christine Hemming, Suzanne Breeman, Andrew Elders, Kevin Cooper, Robert Freeman, Anthony R. B. Smith, Suzanne Hagen, Alison McDonald, Gladys McPherson, Isobel Montgomery, Mary Kilonzo, Dwayne Boyers, Beatriz Goulao, John Norrie

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effectiveness of the peer delivered Thinking Healthy Plus (THPP+) Programme for maternal depression and child socio-emotional development in Pakistan: study protocol for a three-year cluster randomized controlled trial

Elizabeth L. Turner, Siham Sikander, Omer Bangash, Ahmed Zaidi, Lisa Bates, John Gallis, Nima Ganga, Karen O’Donnell, Atif Rahman, Joanna Maselko

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research

Christopher Megone, Eleanor Wilman, Sandy Oliver, Lelia Duley, Gill Gyte, Judy Wright

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The Mental Health in Diabetes Service (MINDS) to enhance psychosocial health: study protocol for a randomized controlled trial

Casey L. O’Brien, Chantal F. Ski, David R. Thompson, Gaye Moore, Serafino Mancuso, Alicia Jenkins, Glenn Ward, Richard J. MacIsaac, Margaret Loh, Simon R. Knowles, Susan L. Rossell, David J. Castle

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

Trialling of an optimal health programme (OHP) across chronic disease

Chantal F. Ski, David R. Thompson, David J. Castle

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The Stroke and Carer Optimal Health Program (SCOHP) to enhance psychosocial health: study protocol for a randomized controlled trial

Catherine Brasier, Chantal F. Ski, David R. Thompson, Jan Cameron, Casey L. O’Brien, Nicola T. Lautenschlager, Graeme Gonzales, Ya-seng Arthur Hsueh, Gaye Moore, Simon R. Knowles, Susan L. Rossell, Rachel Haselden, David J. Castle

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Design and protocol for the Dialysis Optimal Health Program (DOHP) randomised controlled trial

Simon R. Knowles, Chantal F. Ski, Robyn Langham, Emmet O’Flaherty, David R. Thompson, Susan L. Rossell, Gaye Moore, Ya-seng (Arthur) Hsueh, David J. Castle

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Prevention of catheter-related bladder discomfort – pudendal nerve block with ropivacaine versus intravenous tramadol: study protocol for a randomized controlled trial

Jing-yi Li, Ren Liao

01.12.2016 | Research | Ausgabe 1/2016 Open Access

How to select outcome measurement instruments for outcomes included in a “Core Outcome Set” – a practical guideline

Cecilia A. C. Prinsen, Sunita Vohra, Michael R. Rose, Maarten Boers, Peter Tugwell, Mike Clarke, Paula R. Williamson, Caroline B. Terwee

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of a musical intervention on tolerance and efficacy of non-invasive ventilation in the ICU: study protocol for a randomized controlled trial (MUSique pour l’Insuffisance Respiratoire Aigue - Mus-IRA)

Jonathan Messika, David Hajage, Nataly Panneckoucke, Serge Villard, Yolaine Martin, Emilie Renard, Annie Blivet, Jean Reignier, Natacha Maquigneau, Annabelle Stoclin, Christelle Puechberty, Stéphane Guétin, Aline Dechanet, Amandine Fauquembergue, Stéphane Gaudry, Didier Dreyfuss, Jean-Damien Ricard

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Qing-Xin-Jie-Yu Granules in addition to conventional treatment for patients with stable coronary artery disease (QUEST Trial): study protocol for a randomized controlled trial

Shengyao Li, Ming Guo, Huimin Mao, Zhuye Gao, Hao Xu, Dazhuo Shi

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial

Gregory E. Simon, Arne Beck, Rebecca Rossom, Julie Richards, Beth Kirlin, Deborah King, Lisa Shulman, Evette J. Ludman, Robert Penfold, Susan M. Shortreed, Ursula Whiteside

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Cancer@Work — a nurse-led, stepped-care, e-health intervention to enhance the return to work of patients with cancer: study protocol for a randomized controlled trial

Sietske J. Tamminga, Jan L. Hoving, Monique H. W. Frings-Dresen, Angela G. E. M. de Boer

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Hughes Abdominal Repair Trial (HART) – Abdominal wall closure techniques to reduce the incidence of incisional hernias: study protocol for a randomised controlled trial

J. Cornish, R. L. Harries, D. Bosanquet, B. Rees, J. Ansell, N. Frewer, P. K. Dhruva Rao, C. Parry, R. Ellis-Owen, S. M. Phillips, C. Morris, J. Horwood, M. L. Davies, M. M. Davies, R. Hargest, Z. Davies, J. Hilton, D. Harris, A. Ben-Sassi, R. Rajagopal, D. Hanratty, S. Islam, A. Watkins, N. Bashir, S. Jones, I. R. Russell, J. Torkington, on behalf of the HART Trial Management Group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Guided Act and Feel Indonesia (GAF-ID) – Internet-based behavioral activation intervention for depression in Indonesia: study protocol for a randomized controlled trial

Retha Arjadi, Maaike H. Nauta, Willem F. Scholte, Steven D. Hollon, Neerja Chowdhary, Angela O. Suryani, Claudi L. H. Bockting

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Chemotherapy plus Ofatumumab at Standard or Mega dose in relapsed CLL (COSMIC) trial: study protocol for a phase II randomised controlled trial

Dena R. Howard, Talha Munir, Anna Hockaday, Andy C. Rawstron, Laura Collett, Jamie B. Oughton, David Allsup, Adrian Bloor, David Phillips, Peter Hillmen

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effect of chiropractic treatment on the reaction and response times of special operation forces military personnel: study protocol for a randomized controlled trial

James W. DeVocht, Dean L. Smith, Cynthia R. Long, Lance Corber, Bridget Kane, Thomas M. Jones, Christine M. Goertz

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Recruitment and representativeness of blood donors in the INTERVAL randomised trial assessing varying inter-donation intervals

Carmel Moore, Thomas Bolton, Matthew Walker, Stephen Kaptoge, David Allen, Michael Daynes, Susan Mehenny, Jennifer Sambrook, Nicholas A. Watkins, Gail Miflin, Emanuele Di Angelantonio, Willem H. Ouwehand, David J. Roberts, John Danesh, Simon G. Thompson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Lapatinib-capecitabine versus capecitabine alone as radiosensitizers in RAS wild-type resectable rectal cancer, an adaptive randomized phase II trial (LaRRC trial): study protocol for a randomized controlled trial

Nuno Sousa, Olga Sousa, Lúcio Lara Santos, Rui Henrique, Manuel R. Teixeira, Mário Dinis-Ribeiro, Armando Teixeira-Pinto

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A home-based exercise intervention for caregivers of persons with dementia: study protocol for a randomised controlled trial

Wai Chi Chan, Nicola Lautenschlager, Briony Dow, Suk Ling Ma, Corine Sau Man Wong, Linda Chiu Wa Lam

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness and cost-effectiveness of telephone consultations for fever or gastroenteritis using a formalised procedure in general practice: study protocol of a cluster randomised controlled trial

Paul-Georges Reuter, Thibaut Desmettre, Sabine Guinemer, Olivier Ducros, Stéphane Begey, Agnès Ricard-Hibon, Laurianne Billier, Océane Grignon, Isabelle Megy-Michoux, Jean-Noël Latouff, Adeline Sourbes, Julien Latier, Isabelle Durand-Zaleski, Frédéric Lapostolle, Eric Vicaut, Frédéric Adnet

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A multidisciplinary telehealth program in patients with combined chronic obstructive pulmonary disease and chronic heart failure: study protocol for a randomized controlled trial

Palmira Bernocchi, Simonetta Scalvini, Tiziana Galli, Mara Paneroni, Doriana Baratti, Ottavia Turla, Maria Teresa La Rovere, Maurizio Volterrani, Michele Vitacca

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Exploring methods the for selection and integration of stakeholder views in the development of core outcome sets: a case study in reconstructive breast surgery

Shelley Potter, Sara T. Brookes, Christopher Holcombe, Joseph A. Ward, Jane M. Blazeby

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A feasibility study to prevent falls in older people who are sight impaired: the VIP2UK randomised controlled trial

Heather Waterman, Claire Ballinger, Caroline Brundle, Sebastien Chastin, Heather Gage, Robert Harper, David Henson, Bob Laventure, Lisa McEvoy, Mark Pilling, Nicky Olleveant, Dawn A Skelton, Penelope Stanford, Chris Todd

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: ‘Effectiveness of biomarker-based exclusion of ventilator-acquired pneumonia to reduce antibiotic use (VAPrapid-2): study protocol for a randomised controlled trial’

Thomas P. Hellyer, Niall H. Anderson, Jennie Parker, Paul Dark, Tina Van Den Broeck, Suveer Singh, Ronan McMullan, Ashley M. Agus, Lydia M. Emerson, Bronagh Blackwood, Savita Gossain, Tim S. Walsh, Gavin D. Perkins, Andrew Conway Morris, Daniel F. McAuley, A. John Simpson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The ABBA study – approach bias modification in bulimia nervosa and binge eating disorder: study protocol for a randomised controlled trial

Timo Brockmeyer, Ulrike Schmidt, Hans-Christoph Friederich

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial

Eliza G. Miller, Caryl A. Nowson, David W. Dunstan, Deborah A. Kerr, Vicky Solah, David Menzies, Robin M. Daly

01.12.2016 | Research | Ausgabe 1/2016 Open Access

How to design clinical rehabilitation trials for the upper paretic limb early post stroke?

Caroline Winters, Martijn W. Heymans, Erwin E. H. van Wegen, Gert Kwakkel

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy and mechanisms of imagery rescripting and imaginal exposure for nightmares: study protocol for a randomized controlled trial

Anna E. Kunze, Jaap Lancee, Nexhmedin Morina, Merel Kindt, Arnoud Arntz

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Assessment of three fasting plasma glucose targets for insulin glargine-based therapy in people with type 2 diabetes mellitus in China: study protocol for a randomized controlled trial

Wenying Yang, Zhaojun Yang, Jing Zhao, Hai Lu, Tianhong Luo

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Metamizole versus ibuprofen at home after day surgery: study protocol for a randomised controlled trial

Björn Stessel, Michiel Boon, Elbert A. Joosten, Jean-Paul Ory, Stefan Evers, Sander M. J. van Kuijk, Jasperina Dubois, Daisy Hoofwijk, Luc Jamaer, Wolfgang F. F. A. Buhre

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Improving GHB withdrawal with baclofen: study protocol for a feasibility study for a randomised controlled trial

Anne Lingford-Hughes, Yash Patel, Owen Bowden-Jones, Mike J. Crawford, Paul I. Dargan, Fabiana Gordon, Steve Parrott, Tim Weaver, David M. Wood

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Citation bias favoring positive clinical trials of thrombolytics for acute ischemic stroke: a cross-sectional analysis

Benjamin S. Misemer, Timothy F. Platts-Mills, Christopher W. Jones

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Prevention of nosocomial infections in critically ill patients with lactoferrin (PREVAIL study): study protocol for a randomized controlled trial

John Muscedere, David Maslove, John Gordon Boyd, Nicole O’Callaghan, Francois Lamontagne, Steven Reynolds, Martin Albert, Rick Hall, Danielle McGolrick, Xuran Jiang, Andrew G. Day

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

STEPWISE – STructured lifestyle Education for People WIth SchizophrEnia: a study protocol for a randomised controlled trial

Rebecca Gossage-Worrall, Richard I. G. Holt, Katharine Barnard, Marian E. Carey, Melanie J. Davies, Chris Dickens, Yvonne Doherty, Charlotte Edwardson, Paul French, Fiona Gaughran, Kathryn Greenwood, Sridevi Kalidindi, Daniel Hind, Kamlesh Khunti, Paul McCrone, Jonathan Mitchell, John Pendlebury, Shanaya Rathod, David Shiers, Najma Siddiqi, Lizzie Swaby, Stephen Wright

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Deep brain stimulation of the posterior subthalamic area and the thalamus in patients with essential tremor: study protocol for a randomized controlled pilot trial

Michael T. Barbe, Jeremy Franklin, Daria Kraus, Paul Reker, Till A. Dembek, Niels Allert, Jochen Wirths, Jürgen Voges, Lars Timmermann, Veerle Visser-Vandewalle

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Gait training assisted by multi-channel functional electrical stimulation early after stroke: study protocol for a randomized controlled trial

Maijke van Bloemendaal, Sicco A. Bus, Charlotte E. de Boer, Frans Nollet, Alexander C. H. Geurts, Anita Beelen

01.12.2016 | Letter | Ausgabe 1/2016 Open Access

Realist trials and the testing of context-mechanism-outcome configurations: a response to Van Belle et al.

Chris Bonell, Emily Warren, Adam Fletcher, Russell Viner

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Treatment of unilateral spatial neglect after stroke using transcranial direct current stimulation (ELETRON trial): study protocol for a randomized controlled trial

Gustavo José Luvizutto, Gabriela Rizzo Soares Rizzati, Marcelo Ortolani Fogaroli, Rodrigo Thomazi Rodrigues, Priscila Watson Ribeiro, Hélio Rubens de Carvalho Nunes, Gabriel Pereira Braga, Rafael Dalle Molle da Costa, Silméia Garcia Zanati Bazan, Luiz Antônio de Lima Resende, Adriana Bastos Conforto, Rodrigo Bazan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial

W. Miles Cox, Leena Subramanian, David E. J. Linden, Michael Lührs, Rachel McNamara, Rebecca Playle, Kerenza Hood, Gareth Watson, Joseph R. Whittaker, Raman Sakhuja, Niklas Ihssen

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Collaborative Assessment and Management of Suicidality (CAMS) compared to treatment as usual (TAU) for suicidal patients: study protocol for a randomized controlled trial

Wenche Ryberg, Roar Fosse, Per Henrik Zahl, Inge Brorson, Paul Møller, Nils Inge Landrø, David Jobes

01.12.2016 | Update | Ausgabe 1/2016 Open Access

A statistical analysis plan for the efficiency and safety of Chinese herbal medicine used concurrently with topical therapy for psoriasis vulgaris

Liming Lu, Meiling Xuan, Yuhong Yan, Geng Li, Li Zhou, Zehuai Wen, Chuanjian Lu

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Assessment of clinical trial participant patient satisfaction: a call to action

Bethann Mangel Pflugeisen, Stacie Rebar, Anne Reedy, Roslyn Pierce, Paul J. Amoroso

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: Simple steps to develop trial follow-up procedures

Ona McCarthy, Rebecca S. French, Ian Roberts, Caroline Free

01.12.2016 | Commentary | Ausgabe 1/2016 Open Access

Risk of selection bias in randomized trials: further insight

Vance W. Berger

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The NSPCC UK Minding the Baby® (MTB) home-visiting programme, supporting young mothers (aged 14–25) in the first 2 years of their baby's life: study protocol for a randomised controlled trial

Elena Longhi, Lynne Murray, Rachael Hunter, David Wellsted, Samantha Taylor-Colls, Kathryn MacKenzie, Gwynne Rayns, Richard Cotmore, Peter Fonagy, Richard M. Pasco Fearon

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Group schema therapy versus group cognitive behavioral therapy for social anxiety disorder with comorbid avoidant personality disorder: study protocol for a randomized controlled trial

Astrid Baljé, Anja Greeven, Anne van Giezen, Kees Korrelboom, Arnoud Arntz, Philip Spinhoven

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial

Xixue Zhang, Jionglin Wei, Xiaoxing Song, Yuhao Zhang, Weiqing Qian, Lu Sheng, Zhoujun Shen, Lvjun Yang, Rong Dong, Weidong Gu

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Optimising the validity and completion of adherence diaries: a multiple case study and randomised crossover trial

Rachael Frost, Doreen McClurg, Marian Brady, Brian Williams

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Scalp acupuncture and electromagnetic convergence stimulation for patients with cerebral infarction: study protocol for a randomized controlled trial

Jae-Young Han, Jae-Hong Kim, Ju-Hyung Park, Min-Yeong Song, Min-Keun Song, Dong-Joo Kim, Young-Nim You, Gwang-Cheon Park, Jin-Bong Choi, Myung-Rae Cho, Jeong-Cheol Shin, Ji-Hyun Cho

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of probiotics (Vivomixx®) in obese pregnant women and their newborn: study protocol for a randomized controlled trial

Sofie Ingdam Halkjaer, Lisbeth Nilas, Emma Malchau Carlsen, Dina Cortes, Thórhallur Ingi Halldórsson, Sjúrdur Frodi Olsen, Anders Elm Pedersen, Karen Angeliki Krogfelt, Andreas Munk Petersen

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Perioperative and long-term outcomes of liver resection for hepatitis B virus-related hepatocellular carcinoma without versus with hepatic inflow occlusion: study protocol for a prospective randomized controlled trial

Yinzhe Xu, Jiye Chen, Hongguang Wang, Hui Zheng, Dan Feng, Aiqun Zhang, Jianjun Leng, Weidong Duan, Zhanyu Yang, Mingyi Chen, Xianjie Shi, Shouwang Cai, Wenbin Ji, Kai Jiang, Wenzhi Zhang, Yongliang Chen, Wanqing Gu, Jiahong Dong, Shichun Lu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Southampton PRegnancy Intervention for the Next Generation (SPRING): protocol for a randomised controlled trial

Janis Baird, Mary Barker, Nicholas C. Harvey, Wendy Lawrence, Christina Vogel, Megan Jarman, Rufia Begum, Tannaze Tinati, Pamela Mahon, Sofia Strommer, Taylor Rose, Hazel Inskip, Cyrus Cooper

01.12.2016 | Research | Ausgabe 1/2016 Open Access

What can we learn from trial decliners about improving recruitment? Qualitative study

Adwoa Hughes-Morley, Bridget Young, Roelie J. Hempel, Ian T. Russell, Waquas Waheed, Peter Bower

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effects of linagliptin on endothelial function and global arginine bioavailability ratio in coronary artery disease patients with early diabetes: study protocol for a randomized controlled trial

Norbert J. Tripolt, Felix Aberer, Regina Riedl, Barbara Hutz, Jasmin Url, Gudrun Dimsity, Andreas Meinitzer, Tatjana Stojakovic, Ronald Hödl, Marianne Brodmann, Franz Hafner, Harald Sourij

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial

Valery S. Effoe, Jeffrey A. Katula, Julienne K Kirk, Carolyn F Pedley, Linda Y. Bollhalter, W. Mark Brown, Margaret R. Savoca, Stedman T. Jones, Janet Baek, Alain G. Bertoni, the LIFT Diabetes Research Team

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Characteristics of men responding to an invitation to undergo testing for prostate cancer as part of a randomised trial

Eleanor I. Walsh, Emma L. Turner, J. Athene Lane, Jenny L. Donovan, David E. Neal, Freddie C. Hamdy, Richard M. Martin, and the CAP & ProtecT Trial Groups, Investigators, Research staff, Management Committee, CAP & ProtecT Trial Steering Committee, Data Monitoring Committee, Administrative staff

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial

Lianne M. Tomfohr-Madsen, Tavis S. Campbell, Gerald F. Giesbrecht, Nicole L. Letourneau, Linda E. Carlson, Joshua W. Madsen, Sona Dimidjian

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

FourFold Asthma Study (FAST): a study protocol for a randomised controlled trial evaluating the clinical cost-effectiveness of temporarily quadrupling the dose of inhaled steroid to prevent asthma exacerbations

Andrew Skeggs, Tricia McKeever, Lelia Duley, Eleanor Mitchell, Lucy Bradshaw, Kevin Mortimer, Samantha Walker, Steve Parrott, Andrew Wilson, Ian Pavord, Chris Brightling, Mike Thomas, David Price, Graham Devereux, Bernard Higgins, Tim Harrison, Rebecca Haydock

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Neurally adjusted ventilatory assist in patients with acute respiratory failure: study protocol for a randomized controlled trial

Jesús Villar, Javier Belda, Jesús Blanco, Fernando Suarez-Sipmann, José Manuel Añón, Lina Pérez-Méndez, Carlos Ferrando, Dácil Parrilla, Raquel Montiel, Ruth Corpas, Elena González-Higueras, David Pestaña, Domingo Martínez, Lorena Fernández, Marina Soro, Miguel Angel García-Bello, Rosa Lidia Fernández, Robert M. Kacmarek, the NAVa In Acute respiraTORy failure (NAVIATOR) Network

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): study protocol for a randomised controlled trial

Karen L. Barker, David Beard, Andrew Price, Francine Toye, Martin Underwood, Avril Drummond, Gary Collins, Susan Dutton, Helen Campbell, Nicola Kenealy, Jon Room, Sarah E. Lamb

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of a pharmacist-driven intervention in COPD (EPIC): study protocol for a randomized controlled trial

Erin Davis, Carlo Marra, John-Michael Gamble, Jamie Farrell, Joe Lockyer, J. Mark FitzGerald, Waseem Abu-Ashour, Charlie Gillis, John Hawboldt

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Depression: an exploratory parallel-group randomised controlled trial of Antenatal guided self help for WomeN (DAWN): study protocol for a randomised controlled trial

Kylee Trevillion, Jill Domoney, Andrew Pickles, Debra Bick, Sarah Byford, Margaret Heslin, Jeannette Milgrom, Rachel Mycroft, Carmine Pariante, Elizabeth Ryan, Myra Hunter, Louise Michele Howard

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial

Cindy X. Guo, Raiju J. Babu, Joanna M. Black, William R. Bobier, Carly S. Y. Lam, Shuan Dai, Tina Y. Gao, Robert F. Hess, Michelle Jenkins, Yannan Jiang, Lionel Kowal, Varsha Parag, Jayshree South, Sandra Elfride Staffieri, Natalie Walker, Angela Wadham, Benjamin Thompson, on behalf of the BRAVO study team

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Intrathoracic versus Cervical ANastomosis after minimally invasive esophagectomy for esophageal cancer: study protocol of the ICAN randomized controlled trial

Frans van Workum, Stefan A. W. Bouwense, Misha D. P. Luyer, Grard A. P. Nieuwenhuijzen, Donald L. van der Peet, Freek Daams, Ewout A. Kouwenhoven, Marc J van Det, Frits J. H. van den Wildenberg, Fatih Polat, Suzanne S. Gisbertz, Mark I. van Berge Henegouwen, Joos Heisterkamp, Barbara S. Langenhoff, Ingrid S. Martijnse, Janneke P. Grutters, Bastiaan R. Klarenbeek, Maroeska M. Rovers, Camiel Rosman

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial

Suguru Kimoto, Yasuhiko Kawai, Atsuko Gunji, Hisatomo Kondo, Taro Nomura, Tomohiko Murakami, Akito Tsuboi, Guang Hong, Shunsuke Minakuchi, Yusuke Sato, Gaku Ohwada, Tetsuya Suzuki, Katsuhiko Kimoto, Noriyuki Hoshi, Makiko Saita, Yoshikazu Yoneyama, Yohei Sato, Masakazu Morokuma, Joji Okazaki, Takeshi Maeda, Kenichiro Nakai, Tetsuo Ichikawa, Kan Nagao, Keiko Fujimoto, Hiroshi Murata, Tadafumi Kurogi, Kazuhiro Yoshida, Masahiro Nishimura, Yasuhiro Nishi, Mamoru Murakami, Toshio Hosoi, Taizo Hamada

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Medicine in spine exercise (MiSpEx) for nonspecific low back pain patients: study protocol for a multicentre, single-blind randomized controlled trial

Daniel Niederer, Lutz Vogt, Pia-Maria Wippert, Anne-Katrin Puschmann, Ann-Christin Pfeifer, Marcus Schiltenwolf, Winfried Banzer, Frank Mayer

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Wristband Accelerometers to motiVate arm Exercise after Stroke (WAVES): study protocol for a pilot randomized controlled trial

Sarah A. Moore, Ruth Da Silva, Madelaine Balaam, Lianne Brkic, Dan Jackson, Dan Jamieson, Thomas Ploetz, Helen Rodgers, Lisa Shaw, Frederike van Wijck, Christopher Price

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18–30 years) exposed to a high familial breast/ovarian cancer risk: study protocol for a randomized controlled trial

Fabrice Kwiatkowski, Pascal Dessenne, Claire Laquet, Jean-Pierre Daures, Mathilde Gay-Bellile, Yves-Jean Bignon

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of oily fish intake on cardiovascular risk markers, cognitive function, and behavior in school-aged children: study protocol for a randomized controlled trial

Camilla T. Damsgaard, Lotte Lauritzen, Hanne Hauger, Stine Vuholm, Marie N. Teisen, Christian Ritz, Max Hansen, Janni Niclasen, Christian Mølgaard

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparing the effectiveness of the BPMAP (Blood Pressure Management Application) and usual care in self-management of primary hypertension and adherence to treatment in patients aged 30–60 years: study protocol for a randomized controlled trial

Mahnaz Ashoorkhani, Ali Bozorgi, Reza Majdzadeh, Hamed Hosseini, Ali Yoonessi, Ali Ramezankhani, Hassan Eftekhar

01.12.2016 | Update | Ausgabe 1/2016 Open Access

The effect of berberine on insulin resistance in women with polycystic ovary syndrome: detailed statistical analysis plan (SAP) for a multicenter randomized controlled trial

Ying Zhang, Jin Sun, Yun-Jiao Zhang, Qian-Yun Chai, Kang Zhang, Hong-Li Ma, Xiao-Ke Wu, Jian-Ping Liu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Balance chiropractic therapy for cervical spondylotic radiculopathy: study protocol for a randomized controlled trial

Feng Yang, Wen-xiong Li, Zhu Liu, Li Liu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Is low-dose amitriptyline effective in the management of chronic low back pain? Study protocol for a randomised controlled trial

Donna M. Urquhart, Anita E. Wluka, Malcolm R. Sim, Maurits van Tulder, Andrew Forbes, Stephen J. Gibson, Carolyn Arnold, Chris Fong, Shane N. Anthony, Flavia M. Cicuttini

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention compared to treatment as usual for reduction of cannabis use and of relapse in early psychosis (CIRCLE): a study protocol for a randomised controlled trial

Sonia Johnson, Luke Sheridan Rains, Steven Marwaha, John Strang, Thomas Craig, Tim Weaver, Paul McCrone, Michael King, David Fowler, Stephen Pilling, Louise Marston, Rumana Z. Omar, Meghan Craig, Mark Hinton

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Postprandial effect of breakfast glycaemic index on vascular function, glycaemic control and cognitive performance (BGI study): study protocol for a randomised crossover trial

Natalia Sanchez-Aguadero, Luis Garcia-Ortiz, Maria C. Patino-Alonso, Sara Mora-Simon, Manuel A. Gomez-Marcos, Rosario Alonso-Dominguez, Benigna Sanchez-Salgado, Jose I. Recio-Rodriguez

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Measurement of HbA1c in multicentre diabetes trials – should blood samples be tested locally or sent to a central laboratory: an agreement analysis

Barbara N. Arch, Joanne Blair, Andrew McKay, John W. Gregory, Paul Newland, Carrol Gamble

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Sequential Hybrid CryoMaze Ablation versus Surgical CryoMaze Alone for the Treatment of Atrial Fibrillation (SurHyb): study protocol for a randomized controlled trial

Martin Eisenberger, Alan Bulava, Josef Kautzner, Petr Neuzil, Ales Mokracek, Jiri Hanis, Ladislav Dusek

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Acupuncture for the treatment of phantom limb syndrome in lower limb amputees: a randomised controlled feasibility study

Esmé G. Trevelyan, Warren A. Turner, Lynn Summerfield-Mann, Nicola Robinson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Surefire infusion system versus standard microcatheter use during holmium-166 radioembolization: study protocol for a randomized controlled trial

Andor F. van den Hoven, Jip F. Prince, Rutger C. G. Bruijnen, Helena M. Verkooijen, Gerard C. Krijger, Marnix G. E. H. Lam, Maurice A. A. J. van den Bosch

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effect of skin-to-skin contact at birth, early versus immediate, on the duration of exclusive human lactancy in full-term newborns treated at the Clínica Universidad de La Sabana: study protocol for a randomized clinical trial

Sergio Agudelo, Oscar Gamboa, Fabio Rodríguez, Sandra Cala, Nathalie Gualdrón, Evelyn Obando, María Lucía Padrón

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Understanding variations in patient screening and recruitment in a multicentre pilot randomised controlled trial: a vignette-based study

Paul Hilton, Brian S. Buckley, Elaine McColl, Denise Howel, Douglas G. Tincello, Catherine Brennand, on behalf of the INVESTIGATE studies group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Visually-guided gait training in paretic patients during the first rehabilitation phase: study protocol for a randomized controlled trial

Cathia Rossano, Philippe Terrier

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Factors associated with study attrition in a pilot randomised controlled trial to explore the role of exercise-assisted reduction to stop (EARS) smoking in disadvantaged groups

T. P. Thompson, C. J. Greaves, R. Ayres, P. Aveyard, F. C. Warren, R. Byng, R. S. Taylor, J. L. Campbell, M. Ussher, S. Michie, R. West, A. H. Taylor

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Internet-based self-help therapy with FearFighter™ versus no intervention for anxiety disorders in adults: study protocol for a randomised controlled trial

Morten Fenger, Jane Lindschou, Christian Gluud, Per Winkel, Lise Jørgensen, Sten Kruse-Blinkenberg, Marianne Lau

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evolving methods to combine cognitive and physical training for individuals with mild cognitive impairment: study protocol for a randomized controlled study

Ya-yun Lee, Ching-yi Wu, Ching-hung Teng, Wen-chuin Hsu, Ku-chou Chang, Poyu Chen

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

High-dose intravenously administered iron versus orally administered iron in blood donors with iron deficiency: study protocol for a randomised, controlled trial

Susanne Macher, Camilla Drexler, Ines Lindenau, Nazanin Sareban, Peter Schlenke, Karin Amrein

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial

U. Teichgräber, R. Aschenbach, D. Scheinert, T. Zeller, K. Brechtel, M. Thieme, E. Blessing, M. Treitl, M. Lichtenberg, P. von Flowtow, B. Vogel, M. Werk, V. Riambau, A. Wienke, T. Lehmann, S. Sixt

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy of naloxone in reducing postictal central respiratory dysfunction in patients with epilepsy: study protocol for a double-blind, randomized, placebo-controlled trial

Sylvain Rheims, Luc Valton, Véronique Michel, Louis Maillard, Vincent Navarro, Philippe Convers, Fabrice Bartolomei, Arnaud Biraben, Arielle Crespel, Philippe Derambure, Bertrand de Toffol, Edouard Hirsch, Philippe Kahane, Martine Lemesle Martin, Didier Tourniaire, Sébastien Boulogne, Catherine Mercier, Pascal Roy, Philippe Ryvlin, on behalf of ENALEPSY study group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Comparative effects of nebivolol and carvedilol on left ventricular diastolic function in older heart failure patients with preserved ejection fraction: study protocol for a randomized controlled trial

Kyungil Park, Tae-Ho Park

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial

Astrid Pozet, Catherine Lejeune, Magalie Bonnet, Sandrine Dabakuyo, Michèle Dion, Philippe Fagnoni, Maryse Gaimard, Geneviève Imbert, Virginie Nerich, Audrey Foubert, Morgane Chotard, Marie Bonin, Amélie Anota, Franck Bonnetain

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Guided self-help interventions for mental health disorders in children with neurological conditions: study protocol for a pilot randomised controlled trial

Sophie Bennett, Isobel Heyman, Anna Coughtrey, Jess Simmonds, Sophia Varadkar, Terence Stephenson, Margaret DeJong, Roz Shafran

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

Túlio Eduardo Nogueira, Shahrokh Esfandiari, Cláudio Rodrigues Leles

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effects of zinc supplementation on obesity: study protocol for a randomized controlled clinical trial

Kumari M. Rathnayake, KDRR Silva, Ranil Jayawardena

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Negative pressure wound therapy versus usual care for Surgical Wounds Healing by Secondary Intention (SWHSI trial): study protocol for a randomised controlled pilot trial

Catherine Arundel, Hannah Buckley, Emma Clarke, Nicky Cullum, Stephen Dixon, Jo Dumville, Caroline Fairhurst, Anna Firth, Eileen Henderson, Karen Lamb, Elizabeth McGinnis, Angela Oswald, Pedro Saramago Goncalves, Marta Soares, Nikki Stubbs, David Torgerson, Ian Chetter

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A core outcome set for neonatal abstinence syndrome: study protocol for a systematic review, parent interviews and a Delphi survey

Lauren E. Kelly, Lauren M. Jansson, Wendy Moulsdale, Jodi Pereira, Sarah Simpson, Astrid Guttman, Karel Allegaert, Lisa Askie, Henry Roukema, Thierry Lacaze, Jonathan M. Davis, Loretta Finnegan, Paula Williamson, Martin Offringa

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Cornerstone program for transition-age youth with serious mental illness: study protocol for a randomized controlled trial

Michelle R. Munson, Andrea Cole, Victoria Stanhope, Steven C. Marcus, Mary McKay, James Jaccard, Shelly Ben-David

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Improving early childhood care and development, HIV-testing, treatment and support, and nutrition in Mokhotlong, Lesotho: study protocol for a cluster randomized controlled trial

Mark Tomlinson, Sarah Skeen, Marguerite Marlow, Lucie Cluver, Peter Cooper, Lynne Murray, Shoeshoe Mofokeng, Nathene Morley, Moroesi Makhetha, Sarah Gordon, Tonya Esterhuizen, Lorraine Sherr

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Combined effect of new complete dentures and simple dietary advice on nutritional status in edentulous patients: study protocol for a randomized controlled trial

Yuriko Komagamine, Manabu Kanazawa, Maiko Iwaki, Ayami Jo, Hiroyuki Suzuki, Noriko Amagai, Shunsuke Minakuchi

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial

Tim G. A. Calon, Marc van Hoof, Herbert van den Berge, Arthur J. G. de Bruijn, Joost van Tongeren, Janny R. Hof, Jan Wouter Brunings, Sofia Jonhede, Lucien J. C. Anteunis, Miranda Janssen, Manuela A. Joore, Marcus Holmberg, Martin L. Johansson, Robert J. Stokroos

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

How can we optimise inhaled beta2 agonist dose as ‘reliever’ medicine for wheezy pre-school children? Study protocol for a randomised controlled trial

Somnath Mukhopadhyay, Paul Seddon, Gemma Earl, Emma Wileman, Liz Symes, Cathy Olden, Corinne Alberti, Stephen Bremner, Alison Lansley, Colin N. A. Palmer, Nicole Beydon

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Regional Anesthesia for Painful Injuries after Disasters (RAPID): study protocol for a randomized controlled trial

Adam C. Levine, Carrie Teicher, Adam R. Aluisio, Tess Wiskel, Pola Valles, Miguel Trelles, Justin Glavis-Bloom, Rebecca F. Grais

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

PRONTOX – proton therapy to reduce acute normal tissue toxicity in locally advanced non-small-cell lung carcinomas (NSCLC): study protocol for a randomised controlled trial

Sebastian Zschaeck, Monique Simon, Steffen Löck, Esther G. C. Troost, Kristin Stützer, Patrick Wohlfahrt, Steffen Appold, Sebastian Makocki, Rebecca Bütof, Christian Richter, Michael Baumann, Mechthild Krause

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The Carotid and Middle cerebral artery Occlusion Surgery Study (CMOSS): a study protocol for a randomised controlled trial

Yan Ma, Yuxiang Gu, Xiaoguang Tong, Jiyue Wang, Dong Kuai, Donghai Wang, Jun Ren, Lian Duan, Aili Maimaiti, Yiling Cai, Yujie Huang, Xiaojian Wang, Yi Cao, Chao You, Jiasheng Yu, Liqun Jiao, Feng Ling

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Development of a prognostic model based on demographic, environmental and lifestyle information for predicting incidences of symptomatic respiratory or gastrointestinal infection in adult office workers

Tapani Hovi, Jukka Ollgren, Jaason Haapakoski, Carita Savolainen-Kopra

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect of acupuncture on insomnia following stroke: study protocol for a randomized controlled trial

Yan Cao, Xuan Yin, Francisca Soto-Aguilar, Yiping Liu, Ping Yin, Junyi Wu, Bochang Zhu, Wentao Li, Lixing Lao, Shifen Xu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

An illness-focused interactive booklet to optimise management and medication for childhood fever and infections in out-of-hours primary care: study protocol for a cluster randomised trial

Eefje G. P. M. de Bont, Geert-Jan Dinant, Gijs Elshout, Gijs van Well, Nick A. Francis, Bjorn Winkens, Jochen W. L. Cals

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A pilot and feasibility randomised controlled study of Prolonged Exposure Treatment and supportive counselling for post-traumatic stress disorder in adolescents: a third world, task-shifting, community-based sample

Jaco Rossouw, Elna Yadin, Debra Alexander, Irene Mbanga, Tracy Jacobs, Soraya Seedat

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The NOURISHED randomised controlled trial comparing mentalisation-based treatment for eating disorders (MBT-ED) with specialist supportive clinical management (SSCM-ED) for patients with eating disorders and symptoms of borderline personality disorder

Paul Robinson, Jennifer Hellier, Barbara Barrett, Daiva Barzdaitiene, Anthony Bateman, Alexandra Bogaardt, Ajay Clare, Nadia Somers, Aine O’Callaghan, Kimberley Goldsmith, Nikola Kern, Ulrike Schmidt, Sara Morando, Catherine Ouellet-Courtois, Alice Roberts, Finn Skårderud, Peter Fonagy

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Exceeding the recruitment target in a primary care paediatric trial: an evaluation of the Choice of Moisturiser for Eczema Treatment (COMET) feasibility randomised controlled trial

Kingsley Powell, Victoria J. Wilson, Niamh M. Redmond, Daisy M. Gaunt, Matthew J. Ridd

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Integrating technology into complex intervention trial processes: a case study

Cheney J. G. Drew, Vincent Poile, Rob Trubey, Gareth Watson, Mark Kelson, Julia Townson, Anne Rosser, Kerenza Hood, Lori Quinn, Monica Busse

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Recruiting to Clinical Trials on the Telephone – a randomized controlled trial

Kim Thestrup Foss, Jesper Kjærgaard, Lone Graff Stensballe, Gorm Greisen

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Glycopyrrolate in comparison to hyoscine hydrobromide and placebo in the treatment of hypersalivation induced by clozapine (GOTHIC1): study protocol for a randomised controlled feasibility study

Inti Qurashi, Simon Chu, Nusrat Husain, Richard J. Drake, Imran Chaudhry, J. F. W. Deakin

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Suprascapular neuropathy in the setting of rotator cuff tears: study protocol for a double-blinded randomized controlled trial

Nikolaos Platon Sachinis, Achilleas Boutsiadis, Sotirios Papagiannopoulos, Konstantinos Ditsios, Anastasios Christodoulou, Pericles Papadopoulos

01.12.2016 | Update | Ausgabe 1/2016 Open Access

Two-year clinical follow-up of the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in The Netherlands (MR CLEAN): design and statistical analysis plan of the extended follow-up study

Lucie A. van den Berg, Marcel G. W. Dijkgraaf, Olvert A. Berkhemer, Puck S. S. Fransen, Debbie Beumer, Hester Lingsma, Charles B. M. Majoie, Diederik W. J. Dippel, Aad J. van der Lugt, Robert J. van Oostenbrugge, Wim H. van Zwam, Yvo B. W. E. M. Roos, for the MR CLEAN invesigators

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A trial to determine whether septic shock-reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy versus usual care (SQUEEZE): study protocol for a pilot randomized controlled trial

Melissa J. Parker, Lehana Thabane, Alison Fox-Robichaud, Patricia Liaw, Karen Choong, For the Canadian Critical Care Trials Group and the Canadian Critical Care Translational Biology Group

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

A metadata schema for data objects in clinical research

Steve Canham, Christian Ohmann

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Gentamicin versus ceftriaxone for the treatment of gonorrhoea (G-TOG trial): study protocol for a randomised trial

Clare Brittain, Margaret Childs, Lelia Duley, Jan Harding, Trish Hepburn, Garry Meakin, Alan A. Montgomery, Wei Tan, Jonathan D. C. Ross

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Fitness and mobility training in patients with Intensive Care Unit-acquired muscle weakness (FITonICU): study protocol for a randomised controlled trial

Jan Mehrholz, Simone Thomas, Jane H. Burridge, André Schmidt, Bettina Scheffler, Ralph Schellin, Stefan Rückriem, Daniel Meißner, Katja Mehrholz, Wolfgang Sauter, Ulf Bodechtel, Bernhard Elsner

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial

James E. Neffendorf, Riti Desai, Yanzhong Wang, Joanna Kelly, Caroline Murphy, Barnaby C. Reeves, Usha Chakravarthy, Sarah Wordsworth, Cornelius Lewis, Janet Peacock, Shahir Uddin, Joe M. O’Sullivan, Timothy L. Jackson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Lateral pelvic lymph node dissection after neoadjuvant chemo-radiation for preoperative enlarged lateral nodes in advanced low rectal cancer: study protocol for a randomized controlled trial

Mingtian Wei, Qingbin Wu, Chuanwen Fan, Yan Li, Xiangzheng Chen, Zongguang Zhou, Junhong Han, Ziqiang Wang

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effects of water lubrication of tracheal tubes on post-intubation airway complications: study protocol for a randomized controlled trial

Eugene Kim, Seong Mi Yang, So Jeong Yoon, Jae-Hyon Bahk, Jeong-Hwa Seo

01.12.2016 | Letter | Ausgabe 1/2016 Open Access

Adjuvant therapies in advanced hepatocellular carcinoma: moving forward from the STORM

Mohamed Bouattour, Olivier Soubrane, Armand de Gramont, Sandrine Faivre

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Efficacy of early controlled motion of the ankle compared with no motion after non-operative treatment of an acute Achilles tendon rupture: study protocol for a randomized controlled trial

Kristoffer Weisskirchner Barfod, Maria Swennergren Hansen, Per Holmich, Anders Troelsen, Morten Tange Kristensen

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Curcumin and long-chain Omega-3 polyunsaturated fatty acids for Prevention of type 2 Diabetes (COP-D): study protocol for a randomised controlled trial

Rohith N. Thota, Shamasunder H. Acharya, Kylie A. Abbott, Manohar L. Garg

01.12.2016 | Methodology | Ausgabe 1/2016 Open Access

Design of case report forms based on a public metadata registry: re-use of data elements to improve compatibility of data

Martin Dugas

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial

Edgard Silva Garcia, Daniela Francescato Veiga, Joel Veiga-Filho, Isaías Vieira Cabral, Natália Lana Larcher Pinto, Neil Ferreira Novo, Miguel Sabino Neto, Lydia Masako Ferreira

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial

Linda Kersten, Martin Prätzlich, Sandra Mannstadt, Katharina Ackermann, Gregor Kohls, Helena Oldenhof, Daniel Saure, Katrin Krieger, Beate Herpertz-Dahlmann, Arne Popma, Christine M. Freitag, Robert L. Trestman, Christina Stadler

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Tonic and burst spinal cord stimulation waveforms for the treatment of chronic, intractable pain: study protocol for a randomized controlled trial

Konstantin V. Slavin, Richard B. North, Timothy R. Deer, Peter Staats, Kristina Davis, Roni Diaz

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effects of computer-based mindfulness training on Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains in a healthy student population (SMASH): study protocol for a randomized controlled trial

Zarah Rowland, Mario Wenzel, Thomas Kubiak

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effect on attendance by including focused information on spirometry in preventive health checks: study protocol for a randomized controlled trial

Lene Maria Ørts, Anders Løkke, Anne-Louise Bjerregaard, Helle Terkildsen Maindal, Annelli Sandbæk

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Multipoint Pacing versus conventional ICD in Patients with a Narrow QRS complex (MPP Narrow QRS trial): study protocol for a pilot randomized controlled trial

Maurizio Gasparini, Paola Galimberti, Renato Bragato, Stefano Ghio, Claudia Raineri, Maurizio Landolina, Enrico Chieffo, Maurizio Lunati, Ederina Mulargia, Alessandro Proclemer, Domenico Facchin, Roberto Rordorf, Alessandro Vicentini, Lina Marcantoni, Francesco Zanon, Catherine Klersy

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of enhanced cognitive behavioral therapy (CBT-E) for eating disorders: study protocol for a randomized controlled trial

Martie de Jong, Kees Korrelboom, Iris van der Meer, Mathijs Deen, Hans W. Hoek, Philip Spinhoven

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A randomised, patient-assessor blinded, sham-controlled trial of external non-invasive peripheral nerve stimulation for chronic neuropathic pain following peripheral nerve injury (EN-PENS trial): study protocol for a randomised controlled trial

Selina Johnson, Roberta Richey, Emily Holmes, Dyfrig Hughes, Andreas Goebel

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The quality of reporting in cluster randomised crossover trials: proposal for reporting items and an assessment of reporting quality

Sarah J. Arnup, Andrew B. Forbes, Brennan C. Kahan, Katy E. Morgan, Joanne E. McKenzie

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial

Katherine E. A. Semrau, Lisa R. Hirschhorn, Bhala Kodkany, Jonathan M. Spector, Danielle E. Tuller, Gary King, Stuart Lipsitz, Narender Sharma, Vinay Pratap Singh, Bharath Kumar, Neelam Dhingra-Kumar, Rebecca Firestone, Vishwajeet Kumar, Atul A. Gawande

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

NETS1HD: study protocol for development of a core outcome set for use in determining the overall success of Hirschsprung’s disease treatment

Benjamin Allin, Timothy Bradnock, Simon Kenny, Gregor Walker, Marian Knight

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery – AIR: study protocol for a randomised controlled trial

Svajunas Statkevicius, Johan Bonnevier, Björn P. Bark, Erik Larsson, Carl M. Öberg, Päivi Kannisto, Bobby Tingstedt, Peter Bentzer

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The RAPID-CTCA trial (Rapid Assessment of Potential Ischaemic Heart Disease with CTCA) — a multicentre parallel-group randomised trial to compare early computerised tomography coronary angiography versus standard care in patients presenting with suspected or confirmed acute coronary syndrome: study protocol for a randomised controlled trial

Alasdair J. Gray, Carl Roobottom, Jason E. Smith, Steve Goodacre, Katherine Oatey, Rachel O’Brien, Robert F. Storey, Lumine Na, Steff C. Lewis, Praveen Thokala, David E. Newby

01.12.2016 | Research | Ausgabe 1/2016 Open Access

What is the impact of obtaining medical clearance to participate in a randomised controlled trial examining a physical activity intervention on the socio-demographic and risk factor profiles of included participants?

Mitch J. Duncan, Richard R. Rosenkranz, Corneel Vandelanotte, Cristina M. Caperchione, Amanda L. Rebar, Anthony J. Maeder, Rhys Tague, Trevor N. Savage, Anetta van Itallie, W. Kerry Mummery, Gregory S. Kolt

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The citation of relevant systematic reviews and randomised trials in published reports of trial protocols

Nikolaos Pandis, Padhraig S. Fleming, Despina Koletsi, Sally Hopewell

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The Radical Extent of lymphadenectomy — D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial

Jun-Yang Lu, Lai Xu, Hua-Dan Xue, Wei-Xun Zhou, Tao Xu, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Yi Xiao

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Feasibility of an online intervention (STAK-D) to promote physical activity in children with type 1 diabetes: protocol for a randomised controlled trial

Holly Blake, Helen Quirk, Paul Leighton, Tabitha Randell, James Greening, Boliang Guo, Cris Glazebrook

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Achieving Good Outcomes for Asthma Living (GOAL): mixed methods feasibility and pilot cluster randomised controlled trial of a practical intervention for eliciting, setting and achieving goals for adults with asthma

Gaylor Hoskins, Brian Williams, Purva Abhyankar, Peter Donnan, Edward Duncan, Hilary Pinnock, Marjon van der Pol, Petra Rauchhaus, Anne Taylor, Aziz Sheikh

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Tailored approach to sleep health education (TASHE): study protocol for a web-based randomized controlled trial

Natasha J. Williams, Rebecca Robbins, David Rapoport, John P. Allegrante, Alwyn Cohall, Gbenga Ogedgebe, Girardin Jean-Louis

01.12.2016 | Research | Ausgabe 1/2016 Open Access

The impact of advertising patient and public involvement on trial recruitment: embedded cluster randomised recruitment trial

Adwoa Hughes-Morley, Mark Hann, Claire Fraser, Oonagh Meade, Karina Lovell, Bridget Young, Chris Roberts, Lindsey Cree, Donna More, Neil O’Leary, Patrick Callaghan, Waquas Waheed, Peter Bower

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Abdominal Septic Shock – Endotoxin Adsorption Treatment (ASSET) – endotoxin removal in abdominal and urogenital septic shock with the Alteco® LPS Adsorber: study protocol for a double-blinded, randomized placebo-controlled trial

Miklos Lipcsey, Jyrki Tenhunen, Jan Sjölin, Robert Frithiof, Stepani Bendel, Hans Flaatten, Rafael Kawati, Anne Kuitunen, Tor Inge Tønnessen, Sten Rubertsson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Effectiveness of a girls’ empowerment programme on early childbearing, marriage and school dropout among adolescent girls in rural Zambia: study protocol for a cluster randomized trial

Ingvild Fossgard Sandøy, Mweetwa Mudenda, Joseph Zulu, Ecloss Munsaka, Astrid Blystad, Mpundu C. Makasa, Ottar Mæstad, Bertil Tungodden, Choolwe Jacobs, Linda Kampata, Knut Fylkesnes, Joar Svanemyr, Karen Marie Moland, Richard Banda, Patrick Musonda

01.12.2016 | Review | Ausgabe 1/2016 Open Access

The magnitude and temporal changes of response in the placebo arm of surgical randomized controlled trials: a systematic review and meta-analysis

Karolina A. Wartolowska, Benjamin G. Feakins, Gary S. Collins, Jonathan Cook, Andrew Judge, Ines Rombach, Benjamin J. F. Dean, James A. Smith, Andrew J. Carr

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Health effectiveness and cost-effectiveness of telehealthcare for heart failure: study protocol for a randomized controlled trial

Simon Lebech Cichosz, Lars Holger Ehlers, Ole Hejlesen

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The RESPITE trial: remifentanil intravenously administered patient-controlled analgesia (PCA) versus pethidine intramuscular injection for pain relief in labour: study protocol for a randomised controlled trial

Matthew Wilson, Christine MacArthur, Fang Gao Smith, Leanne Homer, Kelly Handley, Jane Daniels, On behalf of the RESPITE Collaborative Group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial

David H. Gustafson Sr, Gina Landucci, Fiona McTavish, Rachel Kornfield, Roberta A. Johnson, Marie-Louise Mares, Ryan P. Westergaard, Andrew Quanbeck, Esra Alagoz, Klaren Pe-Romashko, Chantelle Thomas, Dhavan Shah

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Early skin-to-skin contact or incubator for very preterm infants: study protocol for a randomized controlled trial

Laila Kristoffersen, Ragnhild Støen, Hilde Rygh, Margunn Sognnæs, Turid Follestad, Hilde S. Mohn, Ingrid Nissen, Håkon Bergseng

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

‘Walk This Way’ – a pilot of a health coaching intervention to reduce sedentary behaviour and increase low intensity exercise in people with serious mental illness: study protocol for a randomised controlled trial

Julie Williams, Brendon Stubbs, Fiona Gaughran, Tom Craig

01.12.2016 | Research | Ausgabe 1/2016 Open Access

Using re-randomization to increase the recruitment rate in clinical trials – an assessment of three clinical areas

Brennan C. Kahan

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Impact of communication strategies to increase knowledge, acceptability, and uptake of a new Woman’s Condom in urban Lusaka, Zambia: study protocol for a randomized controlled trial

Jessie Pinchoff, Rachna Nag Chowdhuri, Noah Taruberekera, Thoai D. Ngo

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial

Ling Cui, Yu Shi, GN Zhang

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Increasing engagement with, and effectiveness of, an online CBT-based stress management intervention for employees through the use of an online facilitated bulletin board: study protocol for a pilot randomised controlled trial

Stephany Carolan, Peter R. Harris, Kathryn Greenwood, Kate Cavanagh

01.12.2016 | Update | Ausgabe 1/2016 Open Access

Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children

Siobhan Creanor, Jenny Lloyd, Melvyn Hillsdon, Sarah Dean, Colin Green, Rod S. Taylor, Emma Ryan, Katrina Wyatt, on behalf of the HeLP Trial Management Group

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The effect of community groups and mobile phone messages on the prevention and control of diabetes in rural Bangladesh: study protocol for a three-arm cluster randomised controlled trial

Edward Fottrell, Hannah Jennings, Abdul Kuddus, Naveed Ahmed, Joanna Morrison, Kohenour Akter, Sanjit Kumar Shaha, Badrun Nahar, Tasmin Nahar, Hassan Haghparast-Bidgoli, A. K. Azad Khan, Anthony Costello, Kishwar Azad

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

The incidence of training responsiveness to cardiorespiratory fitness and cardiometabolic measurements following individualized and standardized exercise prescription: study protocol for a randomized controlled trial

Ryan M. Weatherwax, Nigel K. Harris, Andrew E. Kilding, Lance C. Dalleck

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Fostering Effective Early Learning (FEEL) through a professional development programme for early childhood educators to improve professional practice and child outcomes in the year before formal schooling: study protocol for a cluster randomised controlled trial

Edward Melhuish, Steven J. Howard, Iram Siraj, Cathrine Neilsen-Hewett, Denise Kingston, Marc de Rosnay, Elisabeth Duursma, Betty Luu

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): study protocol for a randomized controlled trial

Andrew McWilliams, Jason Roberge, Charity G. Moore, Avery Ashby, Whitney Rossman, Stephanie Murphy, Stephannie McCall, Ryan Brown, Shannon Carpenter, Scott Rissmiller, Scott Furney

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial

Sarah Brown, Isabelle L. Smith, Julia M. Brown, Claire Hulme, Elizabeth McGinnis, Nikki Stubbs, E. Andrea Nelson, Delia Muir, Claudia Rutherford, Kay Walker, Valerie Henderson, Lyn Wilson, Rachael Gilberts, Howard Collier, Catherine Fernandez, Suzanne Hartley, Moninder Bhogal, Susanne Coleman, Jane E. Nixon

01.12.2016 | Erratum | Ausgabe 1/2016 Open Access

Erratum to: Evaluating the PRASE patient safety intervention - a multi-centre, cluster trial with a qualitative process evaluation: study protocol for a randomised controlled trial

Laura Sheard, Jane O’Hara, Gerry Armitage, John Wright, Kim Cocks, Rosemary McEachan, Ian Watt, Rebecca Lawton

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

A transdiagnostic sleep and circadian treatment to improve severe mental illness outcomes in a community setting: study protocol for a randomized controlled trial

Allison G. Harvey, Kerrie Hein, Lu Dong, Freddie L. Smith, Michael Lisman, Stephanie Yu, Sophia Rabe-Hesketh, Daniel J. Buysse

01.12.2016 | Research | Ausgabe 1/2016 Open Access

A survey of facilitators and barriers to recruitment to the MAGNETIC trial

Geetinder Kaur, Rosalind L. Smyth, Colin V. E. Powell, Paula Williamson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Attention training for infants at familial risk of ADHD (INTERSTAARS): study protocol for a randomised controlled trial

Amy Goodwin, Simona Salomone, Patrick Bolton, Tony Charman, Emily J. H. Jones, Andrew Pickles, Emily Robinson, Tim Smith, Edmund J. S. Sonuga-Barke, Sam Wass, Mark H. Johnson

01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial

Cezar Giosan, Oana Cobeanu, Cristina Mogoaşe, Aurora Szentágotai Tătar, Vlad Mureşan, Rareș Boian