Issue 1/2013
Content (446 Articles)
The NAILED stroke risk factor trial (Nurse based Age independent Intervention to Limit Evolution of Disease after stroke): study protocol for a randomized controlled trial
Thomas Mooe, Lisa Bergström, Anna-Lotta Irewall, Joachim Ögren
Practical health co-operation - the impact of a referral template on quality of care and health care co-operation: study protocol for a cluster randomized controlled trial
Henrik Wåhlberg, Per Christian Valle, Siri Malm, Ann Ragnhild Broderstad
Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D): study protocol for a randomised controlled trial
Matthew P Leighton, Ching Lam, Samir Mehta, Robin C Spiller
The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial
Hans Gustav Thyregod, Lars Søndergaard, Nikolaj Ihlemann, Olaf Franzen, Lars Willy Andersen, Peter Bo Hansen, Peter Skov Olsen, Henrik Nissen, Per Winkel, Christian Gluud, Daniel Andreas Steinbrüchel
Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial
Hadar Lev-Tov, Chin-Shang Li, Sara Dahle, Roslyn Rivkah Isseroff
Improving the application of a practice guideline for the assessment and treatment of suicidal behavior by training the full staff of psychiatric departments via an e-learning supported Train-the-Trainer program: study protocol for a randomized controlled trial
Derek P de Beurs, Marieke H de Groot, Jos de Keijser, Bastiaan Verwey, Jan Mokkenstorm, Jos WR Twisk, Erik van Duijn, Albert M van Hemert, Lia Verlinde, Jan Spijker, Bert van Luijn, Jan Vink, Ad JFM Kerkhof
Introduction to a generalized method for adaptive randomization in trials
Zoë SJ Hoare, Christopher J Whitaker, Rhiannon Whitaker
Collaborative Care for Older Adults with low back pain by family medicine physicians and doctors of chiropractic (COCOA): study protocol for a randomized controlled trial
Christine M Goertz, Stacie A Salsbury, Robert D Vining, Cynthia R Long, Andrew A Andresen, Mark E Jones, Kevin J Lyons, Maria A Hondras, Lisa Z Killinger, Fredric D Wolinsky, Robert B Wallace
Rotterdam Aphasia Therapy Study (RATS) – 3: “The efficacy of intensive cognitive-linguistic therapy in the acute stage of aphasia”; design of a randomised controlled trial
Femke Nouwens, Diederik WJ Dippel, Marjolein de Jong-Hagelstein, Evy G Visch-Brink, Peter J Koudstaal, Lonneke M L de Lau
Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis
Andrew D McRae, Carol Bennett, Judith Belle Brown, Charles Weijer, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Allan Donner, Martin Eccles, Jeremy Grimshaw, Merrick Zwarenstein, Monica Taljaard
The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial
Christine M Freitag, Hannah Cholemkery, Leyla Elsuni, Anne K Kroeger, Stephan Bender, Cornelia Ursula Kunz, Meinhard Kieser
Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial
Byung-Kwan Seo, Jun-Hwan Lee, Won-Suk Sung, Eun-Mo Song, Dae-Jean Jo
Use of the ‘patient journey’ model in the internet-based pre-fitting counseling of a person with hearing disability: study protocol for a randomized controlled trial
Vinaya KC Manchaiah, Dafydd Stephens, Gerhard Andersson, Jerker Rönnberg, Thomas Lunner
Early treatment of posterior crossbite - a randomised clinical trial
Carsten Lippold, Thomas Stamm, Ulrich Meyer, András Végh, Tatjana Moiseenko, Gholamreza Danesh
An oral preparation of Lactobacillus acidophilus for the treatment of uncomplicated acute watery diarrhoea in Vietnamese children: study protocol for a multicentre, randomised, placebo-controlled trial
Marion-Eliëtte Kolader, Ha Vinh, Pham Thi Ngoc Tuyet, Corinne Thompson, Marcel Wolbers, Laura Merson, James I Campbell, Tran Thi Ngoc Dung, Ha Manh Tuan, Nguyen Van Vinh Chau, Jeremy Farrar, H Rogier van Doorn, Stephen Baker
Evaluating the effectiveness of reasoning training in military and civilian chronic traumatic brain injury patients: study protocol
Daniel C Krawczyk, Carlos Marquez de la Plata, Guido F Schauer, Asha K Vas, Molly Keebler, Stephanie Tuthill, Claire Gardner, Tiffani Jantz, Weikei Yu, Sandra B Chapman
Use of the PiCCO system in critically ill patients with septic shock and acute respiratory distress syndrome: a study protocol for a randomized controlled trial
Zhongheng Zhang, Xiao Xu, Min Yao, Huilan Chen, Hongying Ni, Haozhe Fan
Optimal schedule of adjuvant chemotherapy with S-1 for stage III colon cancer: study protocol for a randomized controlled trial
Kenichi Yoshimura, Keisuke Uehara, Yuichiro Tojima, Satoru Kawai, Yasuji Mokuno, Atsuyuki Maeda, Takanori Kyokane, Satoshi Kobayashi, Yuichiro Yoshioka, Masato Nagino
Long-term consistent use of a vaginal microbicide gel among HIV-1 sero-discordant couples in a phase III clinical trial (MDP 301) in rural south-west Uganda
Andrew Abaasa, Angela Crook, Mitzy Gafos, Zacchaeus Anywaine, Jonathan Levin, Symon Wandiembe, Ananta Nanoo, Andrew Nunn, Sheena McCormack, Richard Hayes, Anatoli Kamali
The effectiveness and cost-effectiveness of telephone triage of patients requesting same day consultations in general practice: study protocol for a cluster randomised controlled trial comparing nurse-led and GP-led management systems (ESTEEM)
John L Campbell, Nicky Britten, Colin Green, Tim A Holt, Valerie Lattimer, Suzanne H Richards, David A Richards, Chris Salisbury, Rod S Taylor, Emily Fletcher
The effects on depression of Internet-administered behavioural activation and physical exercise with treatment rationale and relapse prevention: study protocol for a randomised controlled trial
Per Carlbring, Philip Lindner, Christopher Martell, Peter Hassmén, Lars Forsberg, Lars Ström, Gerhard Andersson
Effects of acupuncture treatment on depression insomnia: a study protocol of a multicenter randomized controlled trial
Yuan-Fang Chen, Jian-Hua Liu, Neng-Gui Xu, Zhao-Hui Liang, Zhen-Hua Xu, Shu-Jun Xu, Wen-Bin Fu
Can a core outcome set improve the quality of systematic reviews? – a survey of the Co-ordinating Editors of Cochrane review groups
Jamie J Kirkham, Elizabeth Gargon, Mike Clarke, Paula R Williamson
Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial
Morten Vester-Andersen, Tina Waldau, Jørn Wetterslev, Morten Hylander Møller, Jacob Rosenberg, Lars Nannestad Jørgensen, Inger Gillesberg, Henrik Loft Jakobsen, Egon Godthåb Hansen, Lone Musaeus Poulsen, Jan Skovdal, Ellen Kristine Søgaard, Morten Bestle, Jesper Vilandt, Iben Rosenberg, Rasmus Ehrenfried Berthelsen, Jens Pedersen, Mogens Rørbæk Madsen, Thomas Feurstein, Malene Just Busse, Johnny D H Andersen, Christian Maschmann, Morten Rasmussen, Christian Jessen, Lasse Bugge, Helle Ørding, Ann Merete Møller
Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study)
Gianfranco Parati, Stefano Omboni, Angelo Compare, Enzo Grossi, Edward Callus, Achille Venco, Maurizio Destro, Giuseppe Villa, Paolo Palatini, Enrico Agabiti Rosei, Simonetta Scalvini, Stefano Taddei, Dario Manfellotto, Stefano Favale, Carmine De Matteis, Michele Guglielmi
Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial
Katrine B Buggeskov, Jørn Wetterslev, Niels H Secher, Lars W Andersen, Thomas Jonassen, Daniel A Steinbrüchel
The impact of hotspot-targeted interventions on malaria transmission: study protocol for a cluster-randomized controlled trial
Teun Bousema, Jennifer Stevenson, Amrish Baidjoe, Gillian Stresman, Jamie T Griffin, Immo Kleinschmidt, Edmond J Remarque, John Vulule, Nabie Bayoh, Kayla Laserson, Meghna Desai, Robert Sauerwein, Chris Drakeley, Jonathan Cox
A nurse- and peer-led support program to assist women in gynaecological oncology receiving curative radiotherapy, the PeNTAGOn study (Peer and nurse support trial to assist women in gynaecological oncology): study protocol for a randomised controlled trial
Penelope Schofield, Ilona Juraskova, Rebecca Bergin, Karla Gough, Linda Mileshkin, Meinir Krishnasamy, Kate White, David Bernshaw, Sylvia Penberthy, Sanchia Aranda
Sentinel node in ovarian cancer: study protocol for a phase 1 study
Marjolein Kleppe, Toon Van Gorp, Brigitte FM Slangen, Arnold J Kruse, Boudewijn Brans, Ivo NA Pooters, Koen K Van de Vijver, Roy FPM Kruitwagen
Bronchiectasis exacerbation study on azithromycin and amoxycillin-clavulanate for respiratory exacerbations in children (BEST-2): study protocol for a randomized controlled trial
Anne B Chang, Keith Grimwood, Andrew C Wilson, Peter P van Asperen, Catherine A Byrnes, Kerry-Ann F O’Grady, Theo P Sloots, Colin F Robertson, Paul J Torzillo, Gabrielle B McCallum, Ian B Masters, Helen M Buntain, Ian M Mackay, Jacobus Ungerer, Joanne Tuppin, Peter S Morris
Evaluation of an internet-based aftercare program to improve vocational reintegration after inpatient medical rehabilitation: study protocol for a cluster-randomized controlled trial
Rüdiger Zwerenz, Katharina Gerzymisch, Jens Edinger, Martin Holme, Rudolf J Knickenberg, Sieglinde Spörl-Dönch, Ulrich Kiwus, Manfred E Beutel
The Melbourne Diabetes Prevention Study (MDPS): study protocol for a randomized controlled trial
Nathalie Davis-Lameloise, Andrea Hernan, Edward D Janus, Elizabeth Stewart, Rob Carter, Catherine M Bennett, Sharleen O’Reilly, Benjamin Philpot, Erkki Vartiainen, James A Dunbar
A 12-week multidomain intervention versus active control to reduce risk of Alzheimer’s disease: study protocol for a randomized controlled trial
Kaarin J Anstey, Alex Bahar-Fuchs, Pushpani Herath, George W Rebok, Nicolas Cherbuin
Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial
Sang-Don Park, Chang-Hwan Yoon, Il-Young Oh, Jung-Won Suh, Young-Suk Cho, Tae-Jin Youn, Dong-Ju Choi, In-Ho Chae
The addition of a goal-based motivational interview to treatment as usual to enhance engagement and reduce dropouts in a personality disorder treatment service: results of a feasibility study for a randomized controlled trial
Mary McMurran, W Miles Cox, Diane Whitham, Lucy Hedges
The effectiveness and cost-effectiveness of spinal cord stimulation for refractory angina (RASCAL study): study protocol for a pilot randomized controlled trial
Sam Eldabe, John Raphael, Simon Thomson, Andrea Manca, Mark de Belder, Rajesh Aggarwal, Matthew Banks, Morag Brookes, Susan Merotra, Rashidat Adeniba, Ed Davies, Rod S Taylor
Comparison of prasugrel and clopidogrel reloading on high platelet reactivity in clopidogrel-loaded patients undergoing percutaneous coronary intervention (PRAISE-HPR): a study protocol for a prospective randomized controlled clinical trial
Dong-Hyun Lee, Moo Hyun Kim, Tae-Ho Park, Jong Sung Park, Kyungil Park, Hong-Zhe Zhang, Jeong-Min Seo, Michael S Lee
Study protocol for a randomized controlled trial for anterior inguinal hernia repair: transrectus sheath preperitoneal mesh repair compared to transinguinal preperitoneal procedure
M Wiesje Prins, Giel G Koning, Eric F Keus, Patrick WHE Vriens, Roland MHG Mollen, Willem L Akkersdijk, Cees JHM van Laarhoven
Evaluation of the efficacy of memantine in the treatment of fibromyalgia: study protocol for a doubled-blind randomized controlled trial with six-month follow-up
Bárbara Olivan-Blázquez, Marta Puebla, Bárbara Masluk, Mari-Cruz Pérez-Yus, Raquel Arcega, Eva Andrés, Yolanda López-del-Hoyo, Rosa Magallon, Miquel Roca, Javier Garcia-Campayo
A proposal for reducing the effect of one of many causes of publication bias
Sue M Richards, Julie A Burrett
Phenylephrine versus ephedrine on cerebral perfusion during carotid endarterectomy (PEPPER): study protocol for a randomized controlled trial
Claire WA Pennekamp, Rogier V Immink, Wolfgang F Buhre, Frans L Moll, Gert Jan de Borst
Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial
Gérard Helft, Claude Le Feuvre, Jean Louis Georges, Didier Carrie, Florence Leclercq, Hélène Eltchaninoff, Alain Furber, Fabrice Prunier, Laurent Sebagh, Simon Cattan, Guillaume Cayla, Eric Vicaut, Jean-Philippe Metzger
Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome
Babak Choodari-Oskooei, Mahesh KB Parmar, Patrick Royston, Jack Bowden
The clinical and cost-effectiveness of the BRinging Information and Guided Help Together (BRIGHT) intervention for the self-management support of people with stage 3 chronic kidney disease in primary care: study protocol for a randomized controlled trial
Christian Blickem, Tom Blakeman, Anne Kennedy, Peter Bower, David Reeves, Caroline Gardner, Victoria Lee, Carolyn Chew-Graham, Gerry Richardson, Helen Brooks, Shoba Dawson, Rahena Mossabir, Praksha Jariwala, Angela Swallow, Evan Kontopantelis, Hannah Gaffney, Nicola Small, Eldon Spackman, Anne Rogers
Effectiveness of occupational therapy in Parkinson’s disease: study protocol for a randomized controlled trial
Ingrid HWM Sturkenboom, Maud J Graff, George F Borm, Eddy MM Adang, Maria WG Nijhuis-van der Sanden, Bastiaan R Bloem, Marten Munneke
Assessing the effectiveness and safety of liposomal paclitaxel in combination with cisplatin as first-line chemotherapy for patients with advanced NSCLC with regional lymph-node metastasis: study protocol for a randomized controlled trial (PLC-GC trial)
Luo Hu, Gong Liang, Wang Yuliang, Zhu Bingjing, Zhou Xiangdong, Xu Rufu
Dressing wear time after breast reconstruction: study protocol for a randomized controlled trial
Daniela Francescato Veiga, Joel Veiga-Filho, Carlos Américo Veiga Damasceno, Edilaine Maria Leci Sales, Thiago Bezerra Morais, Wânia Eliza Almeida, Neil Ferreira Novo, Lydia Masako Ferreira
Exploring effective core drug patterns in primary insomnia treatment with Chinese herbal medicine: study protocol for a randomized controlled trial
Shiyan Yan, Runshun Zhang, Xuezhong Zhou, Peng Li, Liyun He, Baoyan Liu
Sustained lung inflation in the delivery room in preterm infants at high risk of respiratory distress syndrome (SLI STUDY): study protocol for a randomized controlled trial
Carlo Dani, Gianluca Lista, Simone Pratesi, Luca Boni, Massimo Agosti, Paolo Biban, Antonio Del Vecchio, Diego Gazzolo, Camilla Gizzi, Rosario Magaldi, Hubert Messner, Fabio Mosca, Fabrizio Sandri, Fabio Scopesi, Daniele Trevisanuto, Giovanni Vento
Commentary: Why we should report results from clinical trial pilot studies
Lawrence Friedman
A pilot study of intraocular use of intensive anti-inflammatory; triamcinolone acetonide to prevent proliferative vitreoretinopathy in eyes undergoing vitreoretinal surgery for open globe trauma; the adjuncts in ocular trauma (AOT) trial: study protocol for a randomised controlled trial
Philip J Banerjee, Malcolm G Woodcock, Catey Bunce, Robert Scott, David G Charteris
Improving adherence to web-based cessation programs: a randomized controlled trial study protocol
Amanda L Graham, Sarah Cha, George D Papandonatos, Nathan K Cobb, Aaron Mushro, Ye Fang, Raymond S Niaura, David B Abrams
Qualitative research within trials: developing a standard operating procedure for a clinical trials unit
Frances Rapport, Mel Storey, Alison Porter, Helen Snooks, Kerina Jones, Julie Peconi, Antonio Sánchez, Stefan Siebert, Kym Thorne, Clare Clement, Ian Russell
Clinical effect of catgut implantation at acupoints for allergic rhinitis: study protocol for a randomized controlled trial
Xinrong Li, Qinxiu Zhang, Luyun Jiang, Tao Li, Min Liu, Huanxing Liu, Xiaopei Wang, Fubing Zhang
Improving community development by linking agriculture, nutrition and education: design of a randomised trial of “home-grown” school feeding in Mali
Edoardo Masset, Aulo Gelli
Pylorus resection or pylorus preservation in partial pancreatico-duodenectomy (PROPP study): study protocol for a randomized controlled trial
Thilo Hackert, Thomas Bruckner, Colette Dörr-Harim, Markus K Diener, Phillip Knebel, Werner Hartwig, Oliver Strobel, Stefan Fritz, Lutz Schneider, Jens Werner, Markus W Büchler
Task-oriented training with computer gaming in people with rheumatoid arthritis or osteoarthritis of the hand: study protocol of a randomized controlled pilot trial
Cynthiav Swarnalatha Srikesavan, Barbara Shay, David B Robinson, Tony Szturm
Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening
Arthur D Wong, John Kirby, Gordon H Guyatt, Paul Moayyedi, Parag Vora, John J You
Zinc supplementation in pre-diabetes: study protocol for a randomized controlled trial
Priyanga Ranasinghe, Ranil Jayawardena, ASAD Pigera, Prasad Katulanda, Godwin R Constantine, Priyadarshani Galappaththy
A phase II, sham-controlled, double-blinded study testing the safety and efficacy of the coronary sinus reducer in patients with refractory angina: study protocol for a randomized controlled trial
E Marc Jolicœur, Shmuel Banai, Timothy D Henry, Marc Schwartz, Serge Doucet, Christopher J White, Elazer Edelman, Stefan Verheye
Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting
Aileen Grant, Shaun Treweek, Tobias Dreischulte, Robbie Foy, Bruce Guthrie
Should I eXtract Every Six dental trial (SIXES): study protocol for a randomized controlled trial
Nicola Innes, Felicity Borrie, David Bearn, Dafydd Evans, Petra Rauchhaus, Steve McSwiggan, Lyndie Foster Page, Fiona Hogarth
Piloting a manualised weight management programme (Shape Up-LD) for overweight and obese persons with mild-moderate learning disabilities: study protocol for a pilot randomised controlled trial
Rebecca J Beeken, Dimitrios Spanos, Sally Fovargue, Rachael Hunter, Rumana Omar, Angela Hassiotis, Michael King, Jane Wardle, Helen Croker
Plasma exchange and glucocorticoid dosing in the treatment of anti-neutrophil cytoplasm antibody associated vasculitis (PEXIVAS): protocol for a randomized controlled trial
Michael Walsh, Peter A Merkel, Chen Au Peh, Wladimir Szpirt, Loïc Guillevin, Charles D Pusey, Janak deZoysa, Natalie Ives, William F Clark, Karen Quillen, Jeffrey L Winters, Keith Wheatley, David Jayne
Evaluation of surgically assisted rapid maxillary expansion with piezosurgery versus oscillating saw and chisel osteotomy - a randomized prospective trial
Majeed Rana, Nils-Claudius Gellrich, Madiha Rana, Jozsef Piffkó, Wolfgang Kater
‘TXT2BFiT’ a mobile phone-based healthy lifestyle program for preventing unhealthy weight gain in young adults: study protocol for a randomized controlled trial
Lana Hebden, Kate Balestracci, Kevin McGeechan, Elizabeth Denney-Wilson, Mark Harris, Adrian Bauman, Margaret Allman-Farinelli
Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial
Wendy Robertson, Sarah Stewart-Brown, Nigel Stallard, Stavros Petrou, Frances Griffiths, Margaret Thorogood, Douglas Simkiss, Rebecca Lang, Kate Reddington, Fran Poole, Gloria Rye, Kamran A Khan, Thomas Hamborg, Joanna Kirby
Intermediate outcomes in randomized clinical trials: an introduction
Armando H Seuc, Alexander Peregoudov, Ana Pilar Betran, Ahmet Metin Gulmezoglu
Procalcitonin, pyuria and proadrenomedullin in the management of urinary tract infections – ‘triple p in uti’: study protocol for a randomized controlled trial
Daniel Drozdov, Anja Thomer, Marc Meili, Stefanie Schwarz, Rita Bossart Kouegbe, Katharina Regez, Merih Guglielmetti, Ursula Schild, Antoinette Conca, Petra Schäfer, Barbara Reutlinger, Cornelia Ottiger, Florian Buchkremer, Alexander Litke, Philipp Schuetz, Andreas Huber, Ulrich Bürgi, Christoph A Fux, Andreas Bock, Beat Müller, Werner C Albrich
Feasibility study of an optimised person-centred intervention to improve mental health and reduce antipsychotics amongst people with dementia in care homes: study protocol for a randomised controlled trial
Rhiannon Whitaker, Clive Ballard, Jane Stafford, Martin Orrell, Esme Moniz-Cook, Robert T Woods, Joanna Murray, Martin Knapp, Barbara Woodward Carlton, Jane Fossey
Falls prevention advice and visual feedback to those at risk of falling: study protocol for a pilot randomized controlled trial
Stephen Uzor, Lynne Baillie, Dawn A Skelton, Phillip J Rowe
Study of Optimal Replacement of Thyroxine in the ElDerly (SORTED): protocol for a mixed methods feasibility study to assess the clinical utility of lower dose thyroxine in elderly hypothyroid patients: study protocol for a randomized controlled trial
Scott Wilkes, Simon Pearce, Vicky Ryan, Tim Rapley, Lorna Ingoe, Salman Razvi
When enough is enough: how the decision was made to stop the FEAST trial: data and safety monitoring in an African trial of Fluid Expansion As Supportive Therapy (FEAST) for critically ill children
Jim Todd, Robert S Heyderman, Philippa Musoke, Tim Peto
Combining attention training with cognitive-behavior therapy in Internet-based self-help for social anxiety: study protocol for a randomized controlled trial
Johanna Boettcher, Gerhard Andersson, Per Carlbring
The Y-Worri Project: study protocol for a randomised controlled trial
Alison L Calear, Helen Christensen, Kathleen M Griffiths, Andrew Mackinnon
Keratinocyte growth factor in acute lung injury to reduce pulmonary dysfunction – a randomised placebo-controlled trial (KARE): study protocol
Laurence JM Cross, Cecilia M O’Kane, Cliona McDowell, Jospeh J Elborn, Michael A Matthay, Daniel F McAuley
Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomized trial (OPTI-SCRIPT study protocol)
Barbara Clyne, Marie C Bradley, Susan M Smith, Carmel M Hughes, Nicola Motterlini, Daniel Clear, Ronan McDonnell, David Williams, Tom Fahey
An educational intervention to reduce the use of potentially inappropriate medications among older adults (EMPOWER study): protocol for a cluster randomized trial
Philippe Martin, Robyn Tamblyn, Sara Ahmed, Cara Tannenbaum
Screening for colorectal cancer with FOBT, virtual colonoscopy and optical colonoscopy: study protocol for a randomized controlled trial in the Florence district (SAVE study)
Lapo Sali, Grazia Grazzini, Francesca Carozzi, Guido Castiglione, Massimo Falchini, Beatrice Mallardi, Paola Mantellini, Leonardo Ventura, Daniele Regge, Marco Zappa, Mario Mascalchi, Stefano Milani
Randomized clinical trials to identify optimal antibiotic treatment duration
C Robert Horsburgh, Kimberly M Shea, Patrick Phillips, Michael LaValley
Effect of variations in depth of neuromuscular blockade on rating of surgical conditions by surgeon and anesthesiologist in patients undergoing laparoscopic renal or prostatic surgery (BLISS trial): study protocol for a randomized controlled trial
Martijn Boon, Christian H Martini, Leon PHJ Aarts, Rob FM Bevers, Albert Dahan
Fluoxetine for motor recovery after acute intracerebral hemorrhage (FMRICH): study protocol for a randomized, double-blind, placebo-controlled, multicenter trial
Juan Manuel Marquez-Romero, Antonio Arauz, José Luis Ruiz-Sandoval, Erick de la Cruz-Estrada, Maria Raquel Huerta-Franco, Gerónimo Aguayo-Leytte, Angélica Ruiz-Franco, Humberto Silos
Investigating the relationship between predictability and imbalance in minimisation: a simulation study
Gladys C McPherson, Marion K Campbell, Diana R Elbourne
Randomized trial of Legflow® paclitaxel eluting balloon and stenting versus standard percutaneous transluminal angioplasty and stenting for the treatment of intermediate and long lesions of the superficial femoral artery (RAPID trial): study protocol for a randomized controlled trial
Amine Karimi, Sanne W de Boer, Daniël AF van den Heuvel, Bram Fioole, Dammis Vroegindeweij, Jan MM Heyligers, Paul NM Lohle, Otto Elgersma, Rudolf PT Nolthenius, Jan Albert Vos, Jean-Paul PM de Vries
Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial
Giovanni Mistraletti, Elena S Mantovani, Paolo Cadringher, Barbara Cerri, Davide Corbella, Michele Umbrello, Stefania Anania, Elisa Andrighi, Serena Barello, Alessandra Di Carlo, Federica Martinetti, Paolo Formenti, Paolo Spanu, Gaetano Iapichino
SWIVIT - Swiss video-intubation trial evaluating video-laryngoscopes in a simulated difficult airway scenario: study protocol for a multicenter prospective randomized controlled trial in Switzerland
Lorenz Theiler, Kristina Hermann, Patrick Schoettker, Georges Savoldelli, Natalie Urwyler, Maren Kleine-Brueggeney, Kristopher L Arheart, Robert Greif
Use of biological mesh versus standard wound care in infected incisional ventral hernias, the SIMBIOSE study: a study protocol for a randomized multicenter controlled trial
Christophe Mariette, Nicolas Briez, Fanette Denies, Benoît Dervaux, Alain Duhamel, Marie Guilbert, Emilie Bruyère, William B Robb, Guillaume Piessen
A genotype-specific, randomized controlled behavioral intervention to improve the neuroemotional outcome of cardiac surgery: study protocol for a randomized controlled trial
Daniela Hauer, Iris-Tatjana Kolassa, Rüdiger Paul Laubender, Ulrich Mansmann, Christian Hagl, Benno Roozendaal, Dominique J-F de Quervain, Gustav Schelling
A pilot study of the effect of spironolactone therapy on exercise capacity and endothelial dysfunction in pulmonary arterial hypertension: study protocol for a randomized controlled trial
Jason M Elinoff, J Eduardo Rame, Paul R Forfia, Mary K Hall, Junfeng Sun, Ahmed M Gharib, Khaled Abd-Elmoniem, Grace Graninger, Bonnie Harper, Robert L Danner, Michael A Solomon
Mobile phone text message intervention to reduce binge drinking among young adults: study protocol for a randomized controlled trial
Brian Suffoletto, Clifton W Callaway, Jeffrey Kristan, Peter Monti, Duncan B Clark
The Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children: study protocol for a randomised controlled trial
Katrina M Wyatt, Jennifer J Lloyd, Charles Abraham, Siobhan Creanor, Sarah Dean, Emma Densham, Wendy Daurge, Colin Green, Melvyn Hillsdon, Virginia Pearson, Rod S Taylor, Richard Tomlinson, Stuart Logan
Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial
Michael Teut, Joern Dahler, Ute Hirschberg, Rainer Luedtke, Henning Albrecht, Claudia M Witt
Revising the ECRIN standard requirements for information technology and data management in clinical trials
Christian Ohmann, Steve Canham, Catherine Cornu, Jochen Dreß, François Gueyffier, Wolfgang Kuchinke, Enrico B Nicolis, Michael Wittenberg
A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial
Christina Irene Günter, Augustinus Bader, Ulf Dornseifer, Silvia Egert, Sebastian Dunda, Gerrit Grieb, Thomas Wolter, Norbert Pallua, Tobias von Wild, Frank Siemers, Peter Mailänder, Oliver Thamm, Carsten Ernert, Michael Steen, Reiner Sievers, Bert Reichert, Afshin Rahmanian-Schwarz, Hans Schaller, Bernd Hartmann, Max Otte, Victoria Kehl, Christian Ohmann, Wolfgang Jelkmann, Hans-Günther Machens
Effects of light-emitting diodes on muscle fatigue and exercise tolerance in patients with COPD: study protocol for a randomized controlled trial
Eduardo Foschini Miranda, Ernesto Cesar Pinto Leal-Junior, Paulo Henrique Marchetti, Simone Dal Corso
Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial
Catherine Malboeuf-Hurtubise, Marie Achille, Serge Sultan, Majorie Vadnais
Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: statistical analysis plan
Martin Dennis, Peter Sandercock, Gordon Murray, John Forbes
Effects of nurse-led motivational interviewing of patients with chronic musculoskeletal pain in preparation of rehabilitation treatment (PREPARE) on societal participation, attendance level, and cost-effectiveness: study protocol for a randomized controlled trial
Vera-Christina Mertens, Mariëlle E J B Goossens, Jeanine A Verbunt, Albere J Köke, Rob J E M Smeets
Model-driven diabetes care: study protocol for a randomized controlled trial
Stein Olav Skrøvseth, Eirik Årsand, Fred Godtliebsen, Ragnar M Joakimsen
Innovative interventions to promote positive dental health behaviors and prevent dental caries in preschool children: study protocol for a randomized controlled trial
Xiaoli Gao, Edward Chin Man Lo, Colman McGrath, Samuel Mun Yin Ho
Update on the collaborative interventions for circulation and depression (COINCIDE) trial: changes to planned methodology of a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease
Peter A Coventry, Karina Lovell, Chris Dickens, Peter Bower, Carolyn Chew-Graham, Andrea Cherrington, Charlotte Garrett, Chris J Gibbons, Clare Baguley, Kate Roughley, Isabel Adeyemi, Chris Keyworth, Waquas Waheed, Mark Hann, Linda Davies, Farheen Jeeva, Chris Roberts, Sarah Knowles, Linda Gask
Treatment of traumatized refugees with Sertraline versus Venlafaxine in combination with psychotherapy – study protocol for a randomized clinical trial
Charlotte Sonne, Jessica Carlsson, Ask Elklit, Erik Lykke Mortensen, Morten Ekstrøm
Ultra-early tranexamic acid after subarachnoid hemorrhage (ULTRA): study protocol for a randomized controlled trial
Menno R Germans, René Post, Bert A Coert, Gabriël JE Rinkel, W Peter Vandertop, Dagmar Verbaan
Efficacy of a dilemma-focused intervention for unipolar depression: study protocol for a multicenter randomized controlled trial
Guillem Feixas, Arturo Bados, Eugeni García-Grau, Adrián Montesano, Gloria Dada, Victoria Compañ, Mari Aguilera, Marta Salla, Joan Miquel Soldevilla, Adriana Trujillo, Clara Paz, Lluís Botella, Sergi Corbella, Luis Ángel Saúl-Gutiérrez, José Cañete, Miquel Gasol, Montserrat Ibarra, Leticia Medeiros-Ferreira, José Soriano, Eugénia Ribeiro, Franz Caspar, David Winter
Challenges for consent and community engagement in the conduct of cluster randomized trial among school children in low income settings: experiences from Kenya
George Okello, Caroline Jones, Maureen Bonareri, Sarah N Ndegwa, Carlos Mcharo, Juddy Kengo, Kevin Kinyua, Margaret M Dubeck, Katherine E Halliday, Matthew CH Jukes, Sassy Molyneux, Simon J Brooker
Methods of creatine kinase-MB analysis to predict mortality in patients with myocardial infarction treated with reperfusion therapy
Renato D Lopes, Yuliya Lokhnygina, Victor Hasselblad, Kristin L Newby, Eric Yow, Christopher B Granger, Paul W Armstrong, Judith S Hochman, James S Mills, Witold Ruzyllo, Kenneth W Mahaffey
Acceptance and Commitment Therapy for anxious children and adolescents: study protocol for a randomized controlled trial
Jessica Swain, Karen Hancock, Angela Dixon, Siew Koo, Jenny Bowman
Efficacy and safety of active negative pressure peritoneal therapy for reducing the systemic inflammatory response after damage control laparotomy (the Intra-peritoneal Vacuum Trial): study protocol for a randomized controlled trial
Derek J Roberts, Craig N Jenne, Chad G Ball, Corina Tiruta, Caroline Léger, Zhengwen Xiao, Peter D Faris, Paul B McBeth, Christopher J Doig, Christine R Skinner, Stacy G Ruddell, Paul Kubes, Andrew W Kirkpatrick
Effectiveness of off-the-shelf footwear in reducing foot pain in Australian Department of Veterans’ Affairs recipients not eligible for medical grade footwear: study protocol for a randomized controlled trial
Hylton B Menz, Nicoletta Frescos, Shannon E Munteanu
The clinical relevance of axillary reverse mapping (ARM): study protocol for a randomized controlled trial
Elisabeth G Klompenhouwer, Paul D Gobardhan, Martinus A Beek, Adri C Voogd, Ernest JT Luiten
Tongue pressure profile training for dysphagia post stroke (TPPT): study protocol for an exploratory randomized controlled trial
Catriona M Steele, Mark A Bayley, Melanie Péladeau-Pigeon, Shauna L Stokely
Translating comparative effectiveness of depression medications into practice by comparing the depression medication choice decision aid to usual care: study protocol for a randomized controlled trial
Annie LeBlanc, Amy E Bodde, Megan E Branda, Kathleen J Yost, Jeph Herrin, Mark D Williams, Nilay D Shah, Holly Van Houten, Kari L Ruud, Laurie J Pencille, Victor M Montori
Comparing the effects of individualized, standard, sham and no acupuncture in the treatment of knee osteoarthritis: a multicenter randomized controlled trial
Eun-Jung Kim, Chi-Yeon Lim, Eun-Yong Lee, Seung-Deok Lee, Kap-Sung Kim
Randomized controlled pilot study of a SystemCHANGE™ weight management intervention in stroke survivors: rationale and protocol
Matthew Plow, Shirley M Moore, John P Kirwan, Fredrick Frost, Irene Katzan, Sue Jaeger, Jay Alberts
Drug-eluting stents or coronary artery bypass grafting for unprotected left main coronary artery disease: a meta-analysis of four randomized trials and seventeen observational studies
Qing Li, Zhi Zhang, Rui-Xing Yin
Evaluation and development of a novel binocular treatment (I-BiT™) system using video clips and interactive games to improve vision in children with amblyopia (‘lazy eye’): study protocol for a randomised controlled trial
Alexander J Foss, Richard M Gregson, Daisy MacKeith, Nicola Herbison, Isabel M Ash, Sue V Cobb, Richard M Eastgate, Trish Hepburn, Anthony Vivian, Diane Moore, Stephen M Haworth
Active ingredients are reported more often for pharmacologic than non-pharmacologic interventions: an illustrative review of reporting practices in titles and abstracts
Nicola McCleary, Eilidh M Duncan, Fiona Stewart, Jill J Francis
An open-label study of effects of acupuncture on chronic fatigue syndrome and idiopathic chronic fatigue: study protocol for a randomized controlled trial
Jung-Eun Kim, Kwon-Eui Hong, Hyeong-Jun Kim, Jin-Bong Choi, Yong-Hyeon Baek, Byung-Kwan Seo, Sanghun Lee, Kyung-Won Kang, Min-Hee Lee, Joo-Hee Kim, Seunghoon Lee, So-Young Jung, Hee-Jung Jung, Mi-Suk Shin, Sun-Mi Choi
A pharmacist-led system-change smoking cessation intervention for smokers admitted to Australian public hospitals (GIVE UP FOR GOOD): study protocol for a randomised controlled trial
Dennis Thomas, Michael J Abramson, Billie Bonevski, Simone Taylor, Susan Poole, Gregory R Weeks, Michael J Dooley, Johnson George
Comparative effectiveness of a complex Ayurvedic treatment and conventional standard care in osteoarthritis of the knee – study protocol for a randomized controlled trial
Claudia M Witt, Andreas Michalsen, Stephanie Roll, Antonio Morandi, Shivnarain Gupta, Mark Rosenberg, Ludwig Kronpaß, Elmar Stapelfeldt, Syed Hissar, Matthias Müller, Christian Kessler
A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis
Paul AJM de Bont, David PG van den Berg, Berber M van der Vleugel, Carlijn de Roos, Cornelis L Mulder, Eni S Becker, Ad de Jongh, Mark van der Gaag, Agnes van Minnen
Community resource centres to improve the health of women and children in Mumbai slums: study protocol for a cluster randomized controlled trial
Neena Shah More, Sushmita Das, Ujwala Bapat, Mahesh Rajguru, Glyn Alcock, Wasundhara Joshi, Shanti Pantvaidya, David Osrin
P6 acupoint stimulation for prevention of postoperative nausea and vomiting in patients undergoing craniotomy: study protocol for a randomized controlled trial
Jian-qin Lv, Rui-zhi Feng, Ning Li
The UP-TECH project, an intervention to support caregivers of Alzheimer’s disease patients in Italy: study protocol for a randomized controlled trial
Carlos Chiatti, Filippo Masera, Joseph M Rimland, Antonio Cherubini, Osvaldo Scarpino, Liana Spazzafumo, Fabrizia Lattanzio
An oral health intervention for people with serious mental illness (Three Shires Early Intervention Dental Trial): study protocol for a randomised controlled trial
Hannah F Jones, Clive E Adams, Andrew Clifton, Jayne Simpson, Graeme Tosh, Peter F Liddle, Patrick Callaghan, Min Yang, Boliang Guo, Vivek Furtado
Accumulating Evidence and Research Organization (AERO) model: a new tool for representing, analyzing, and planning a translational research program
Spencer Phillips Hey, Charles M Heilig, Charles Weijer
Clinical drug trials in general practice: a 10-year overview of protocols
Anja Maria Brænd, Kaspar Buus Jensen, Atle Klovning, Jørund Straand
The MOSAIC study - comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified, anorexia nervosa type: study protocol for a randomized controlled trial
Ulrike Schmidt, Beth Renwick, Anna Lose, Martha Kenyon, Hannah DeJong, Hannah Broadbent, Rachel Loomes, Charlotte Watson, Shreena Ghelani, Lucy Serpell, Lorna Richards, Eric Johnson-Sabine, Nicky Boughton, Linette Whitehead, Jennifer Beecham, Janet Treasure, Sabine Landau
Transfusion requirements in septic shock (TRISS) trial - comparing the effects and safety of liberal versus restrictive red blood cell transfusion in septic shock patients in the ICU: protocol for a randomised controlled trial
Lars B Holst, Nicolai Haase, Jørn Wetterslev, Jan Wernerman, Anders Åneman, Anne B Guttormsen, Pär I Johansson, Sari Karlsson, Gudmundur Klemenzson, Robert Winding, Lars Nebrich, Carsten Albeck, Marianne L Vang, Hans-Henrik Bülow, Jeanie M Elkjær, Jane S Nielsen, Peter Kirkegaard, Helle Nibro, Anne Lindhardt, Ditte Strange, Katrin Thormar, Lone M Poulsen, Pawel Berezowicz, Per M Bådstøløkken, Kristian Strand, Maria Cronhjort, Elsebeth Haunstrup, Omar Rian, Anders Oldner, Asger Bendtsen, Susanne Iversen, Jørn-Åge Langva, Rasmus B Johansen, Niklas Nielsen, Ville Pettilä, Matti Reinikainen, Dorte Keld, Siv Leivdal, Jan-Michael Breider, Inga Tjäder, Nanna Reiter, Ulf Gøttrup, Jonathan White, Jørgen Wiis, Lasse Høgh Andersen, Morten Steensen, Anders Perner
Clinical assessment of complementary treatment with Qishen Yiqi dripping pills on ischemic heart failure: study protocol for a randomized, double-blind, multicenter, placebo-controlled trial (CACT-IHF)
Ya Zhu Hou, Shuai Wang, Zhi Qiang Zhao, Xian Liang Wang, Bin Li, Shan Bin Soh, Jing Yuan Mao
Economic support to improve tuberculosis treatment outcomes in South Africa: a pragmatic cluster-randomized controlled trial
Elizabeth Lutge, Simon Lewin, Jimmy Volmink, Irwin Friedman, Carl Lombard
International subarachnoid aneurysm trial – ISAT Part II: Study protocol for a randomized controlled trial
Tim E Darsaut, Andrew S Jack, Richard S Kerr, Jean Raymond
SMART MOVE - a smartphone-based intervention to promote physical activity in primary care: study protocol for a randomized controlled trial
Liam G Glynn, Patrick S Hayes, Monica Casey, Fergus Glynn, Alberto Alvarez-Iglesias, John Newell, Gearóid ÓLaighin, David Heaney, Andrew W Murphy
Oral flucloxacillin and phenoxymethylpenicillin versus flucloxacillin alone for the emergency department outpatient treatment of cellulitis: study protocol for a randomised controlled trial
Michael Quirke, Abel Wakai, Peadar Gilligan, Ronan O’Sullivan
The key role of Shenyan Kangfu tablets, a Chinese patent medicine for diabetic nephropathy: study protocol for a randomized, double-blind and placebo-controlled clinical trial
Hui Wang, Wei Mu, Jingbo Zhai, Dongmei Xing, Shujie Miao, Jia Wang, Yueyi Deng, Niansong Wang, Hongyu Chen, Hongtao Yang, Xuehong He, Hongcai Shang
Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT)
Linda Clare, Antony Bayer, Alistair Burns, Anne Corbett, Roy Jones, Martin Knapp, Michael Kopelman, Aleksandra Kudlicka, Iracema Leroi, Jan Oyebode, Jackie Pool, Bob Woods, Rhiannon Whitaker
Rationale and design of the HepZero study: a prospective, multicenter, international, open, randomized, controlled clinical study with parallel groups comparing heparin-free dialysis with heparin-coated dialysis membrane (Evodial) versus standard care: study protocol for a randomized controlled trial
Patrick Rossignol, Marc Dorval, Renaud Fay, Joan Fort Ros, Nathalie Loughraieb, Frédérique Moureau, Maurice Laville
Acupuncture for lateral epicondylitis (tennis elbow): study protocol for a randomized, practitioner-assessor blinded, controlled pilot clinical trial
Kyung-Min Shin, Joo-Hee Kim, Seunghoon Lee, Mi-Suk Shin, Tae-Hun Kim, Hyo-Ju Park, Min-Hee Lee, Kwon-Eui Hong, Seungdeok Lee, Sun-Mi Choi
Effects of emotion recognition training on mood among individuals with high levels of depressive symptoms: study protocol for a randomised controlled trial
Sally Adams, Ian S Penton-Voak, Catherine J Harmer, Emily A Holmes, Marcus R Munafò
PARot – assessing platelet-rich plasma plus arthroscopic subacromial decompression in the treatment of rotator cuff tendinopathy: study protocol for a randomized controlled trial
Andrew Carr, Cushla Cooper, Richard Murphy, Bridget Watkins, Kim Wheway, Ines Rombach, David Beard
Impact of a novel molecular TB diagnostic system in patients at high risk of TB mortality in rural South Africa (Uchwepheshe): study protocol for a cluster randomised trial
Richard J Lessells, Graham S Cooke, Nuala McGrath, Mark P Nicol, Marie-Louise Newell, Peter Godfrey-Faussett
Investigating the effectiveness of the Mediterranean diet in pregnant women for the primary prevention of asthma and allergy in high-risk infants: protocol for a pilot randomised controlled trial
Dean A Sewell, Victoria S Hammersley, Graham Devereux, Ann Robertson, Andrew Stoddart, Chris Weir, Allison Worth, Aziz Sheikh
Confronting diversity in the production of clinical evidence goes beyond merely including under-represented groups in clinical trials
Karien Stronks, Nicolien F Wieringa, Anita Hardon
Morning light therapy for juvenile depression and severe mood dysregulation: study protocol for a randomized controlled trial
Sarah Bogen, Tanja Legenbauer, Thorsten Bogen, Stephanie Gest, Thomas Jensch, Silvia Schneider, Martin Holtmann
Testing the credibility, feasibility and acceptability of an optimised behavioural intervention (OBI) for avoidant chronic low back pain patients: protocol for a randomised feasibility study
Tamar Pincus, Shamaila Anwar, Lance McCracken, Alison McGregor, Liz Graham, Michelle Collinson, Amanda J Farrin
A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies
Ben G O Sully, Steven A Julious, Jon Nicholl
Quinolone prophylaxis for the prevention of BK virus infection in kidney transplantation: study protocol for a randomized controlled trial
Atul Humar, John Gill, Olwyn Johnston, Dean Fergusson, Andrew A House, Louise Lebel, Sandra Cockfield, S Joseph Kim, Jeff Zaltzman, Marcelo Cantarovich, Martin Karpinski, Tim Ramsay, Greg A Knoll
Using qualitative evidence on patients’ views to help understand variation in effectiveness of complex interventions: a qualitative comparative analysis
Bridget Candy, Michael King, Louise Jones, Sandy Oliver
ULTIMATE-SHF trial (UdenafiL Therapy to Improve symptoMAtology, exercise Tolerance and hEmodynamics in patients with chronic systolic heart failure): study protocol for a randomized, placebo-controlled, double-blind trial
Kyung-Hee Kim, Hyung-Kwan Kim, In-Chang Hwang, Seung-Pyo Lee, Hyun-Jai Cho, Hyun-Jae Kang, Yong-Jin Kim, Dae-Won Sohn
Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom
Eleanor M Dinnett, Sharon Kean, Elizabeth P Tolmie, Elizabeth S Ronald, Allan Gaw
DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m2: study protocol of a randomized controlled multicenter trial - DRKS00004550
Hannes G Kenngott, Gabriella Clemens, Matthias Gondan, Jonas Senft, Markus K Diener, Gottfried Rudofsky, Peter P Nawroth, Markus W Büchler, Lars Fischer, Beat P Müller-Stich
Exercise to preserve beta cell function in recent-onset type 1 diabetes mellitus (EXTOD) - a study protocol for a pilot randomized controlled trial
Nadia Lascar, Amy Kennedy, Nikki Jackson, Amanda Daley, George Dowswell, Dylan Thompson, Keith Stokes, Sheila Greenfield, Roger Holder, Rob Andrews, Parth Narendran
The effect of covariate adjustment for baseline severity in acute stroke clinicaltrials with responder analysis outcomes
Kyra M Garofolo, Sharon D Yeatts, Viswanathan Ramakrishnan, Edward C Jauch, Karen C Johnston, Valerie L Durkalski
Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone: using stakeholder engagement to design a pragmatic randomized trial and study protocol
Susanne Blödt, Lena Schützler, Wenjing Huang, Daniel Pach, Benno Brinkhaus, Josef Hummelsberger, Barbara Kirschbaum, Kirsten Kuhlmann, Lixing Lao, Fanrong Liang, Anna Mietzner, Nadine Mittring, Sabine Müller, Anna Paul, Carolina Pimpao-Niederle, Stephanie Roll, Huangan Wu, Jiang Zhu, Claudia M Witt
Vitamin D to prevent acute lung injury following oesophagectomy (VINDALOO): study protocol for a randomised placebo controlled trial
Dhruv Parekh, Rachel C A Dancer, Sian Lax, Mark S Cooper, Adrian R Martineau, William D Fraser, Olga Tucker, Derek Alderson, Gavin D Perkins, Fang Gao-Smith, David R Thickett
Ondansetron and simvastatin added to treatment as usual in patients with schizophrenia: study protocol for a randomized controlled trial
Imran B Chaudhry, Nusrat Husain, Mohammad O Husain, Jamie Hallak, Richard Drake, Ajmal Kazmi, Raza ur Rahman, Mohammad M Hamirani, Tayyaba Kiran, Nasir Mehmood, John Stirling, Graham Dunn, Bill Deakin
Data sharing among data monitoring committees and responsibilities to patients and science
Iain Chalmers, Douglas G Altman, Hazel McHaffie, Nancy Owens, Richard WI Cooke
Overshadowing as prevention of anticipatory nausea and vomiting in pediatric cancer patients: study protocol for a randomized controlled trial
Friedemann Geiger, Levke Wolfgram
Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial
Kirstine Laerum Sibilitz, Selina Kikkenborg Berg, Tina Birgitte Hansen, Signe Stelling Risom, Trine Bernholdt Rasmussen, Christian Hassager, Lars Køber, Daniel Steinbrüchel, Christian Gluud, Per Winkel, Lau Caspar Thygesen, Jane Lindschou Hansen, Jean Paul Schmid, Viviane Conraads, Barbara Christina Brocki, Ann-Dorthe Zwisler
Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial
Emma del Carmen Macías-Cortés, Leopoldo Aguilar-Faisal, Juan Asbun-Bojalil
Feasibility of omega-3 fatty acid supplementation as an adjunct therapy for people with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial
Ashley S Fulton, Alison M Hill, Marie T Williams, Peter RC Howe, Peter A Frith, Lisa G Wood, Manohar L Garg, Alison M Coates
Influence of time after extraction on the development of gingival invagination: study protocol for a multicenter pilot randomized controlled clinical trial
Christoph Reichert, Eric Kutschera, Manuel Nienkemper, Sven Scharf, Martin Mengel, Rolf Fimmers, Christine Fuhrmann, Christina Plötz, Lina Gölz, Dieter Drescher, Bert Braumann, Andreas Jäger
Home-based reach-to-grasp training for people after stroke: study protocol for a feasibility randomized controlled trial
Ailie J Turton, Paul Cunningham, Emma Heron, Frederike van Wijck, Cath Sackley, Chris Rogers, Keith Wheatley, Sue Jowett, Steven L Wolf, Paulette van Vliet
Thrombus Aspiration in ThrOmbus containing culpRiT lesions in Non-ST-Elevation Myocardial Infarction (TATORT-NSTEMI): study protocol for a randomized controlled trial
Suzanne de Waha, Ingo Eitel, Steffen Desch, Bruno Scheller, Michael Böhm, Bernward Lauer, Meinrad Gawaz, Tobias Geisler, Oliver Gunkel, Leonhard Bruch, Norbert Klein, Dietrich Pfeiffer, Gerhard Schuler, Uwe Zeymer, Holger Thiele
Trichuris suis ova in relapsing-remitting multiple sclerosis and clinically isolated syndrome (TRIOMS): study protocol for a randomized controlled trial
Berit Rosche, Klaus-Dieter Wernecke, Stephanie Ohlraun, Jan-Markus Dörr, Friedemann Paul
Empiric versus imaging guided left ventricular lead placement in cardiac resynchronization therapy (ImagingCRT): study protocol for a randomized controlled trial
Anders Sommer, Mads Brix Kronborg, Steen Hvitfeldt Poulsen, Morten Böttcher, Bjarne Linde Nørgaard, Kirsten Bouchelouche, Peter Thomas Mortensen, Christian Gerdes, Jens Cosedis Nielsen
Comparison of four skin preparation strategies to prevent catheter-related infection in intensive care unit (CLEAN trial): a study protocol for a randomized controlled trial
Véronique Goudet, Jean-François Timsit, Jean-Christophe Lucet, Alain Lepape, Dorothée Balayn, Sabrina Seguin, Olivier Mimoz
Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose
Kirsty Loudon, Merrick Zwarenstein, Frank Sullivan, Peter Donnan, Shaun Treweek
Examining the challenges of family recruitment to behavioral intervention trials: factors associated with participation and enrollment in a multi-state colonoscopy intervention trial
Rebecca G Simmons, Yuan-Chin Amy Lee, Antoinette M Stroup, Sandra L Edwards, Amy Rogers, Christopher Johnson, Charles L Wiggins, Deirdre A Hill, Rosemary D Cress, Jan Lowery, Scott T Walters, Kory Jasperson, John C Higginbotham, Marc S Williams, Randall W Burt, Marc D Schwartz, Anita Y Kinney
An alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting (ADAPTA): study protocol for a randomized, controlled pilot trial
Judith Watson, Gillian Tober, Duncan Raistrick, Noreen Mdege, Veronica Dale, Helen Crosby, Christine Godfrey, Charlie Lloyd, Paul Toner, Steve Parrott
Selenium supplementation for patients with Graves’ hyperthyroidism (the GRASS trial): study protocol for a randomized controlled trial
Torquil Watt, Per Cramon, Jakob Bue Bjorner, Steen Joop Bonnema, Ulla Feldt-Rasmussen, Christian Gluud, Jeppe Gram, Jane Lindschou Hansen, Laszlo Hegedüs, Nils Knudsen, Pernille Bach-Mortensen, Runa Nolsøe, Birte Nygaard, Flemming Pociot, Maria Skoog, Per Winkel, Åse Krogh Rasmussen
A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial
Simon Hyttel-Sorensen, Topun Austin, Frank van Bel, Manon Benders, Olivier Claris, Eugene Dempsey, Monica Fumagalli, Gorm Greisen, Berit Grevstad, Cornelia Hagmann, Lena Hellström-Westas, Petra Lemmers, Jane Lindschou, Gunnar Naulaers, Wim van Oeveren, Adelina Pellicer, Gerhard Pichler, Claudia Roll, Maria Skoog, Per Winkel, Martin Wolf, Christian Gluud
An evaluation of Croí MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial
Jennifer J Infanti, Fidelma P Dunne, Angela O’Dea, Paddy Gillespie, Irene Gibson, Liam G Glynn, Eoin Noctor, John Newell, Brian E McGuire
Action 3:30: protocol for a randomized feasibility trial of a teaching assistant led extracurricular physical activity intervention
Russell Jago, Mark J Edwards, Ashley R Cooper, Kenneth R Fox, Jane Powell, Simon J Sebire, Melissa Spears, Janice L Thompson, Alan A Montgomery
Medication adherence and tolerability of Alzheimer’s disease medications: study protocol for a randomized controlled trial
Noll L Campbell, Paul Dexter, Anthony J Perkins, Sujuan Gao, Lang Li, Todd C Skaar, Amie Frame, Hugh C Hendrie, Chris M Callahan, Malaz A Boustani
Case management vocational rehabilitation for women with breast cancer after surgery: a feasibility study incorporating a pilot randomised controlled trial
Gill Hubbard, Nicola M Gray, Dolapo Ayansina, Josie M M Evans, Richard G Kyle
Slimming World in Stop Smoking Services (SWISSS): study protocol for a randomized controlled trial
Deborah Lycett, Paul Aveyard, Andrew Farmer, Amanda Lewis, Marcus Munafò
RESTORE: an exploratory trial of an online intervention to enhance self-efficacy to manage problems associated with cancer-related fatigue following primary cancer treatment: study protocol for a randomized controlled trial
Chloe Grimmett, Jo Armes, Matthew Breckons, Lynn Calman, Jessica Corner, Deborah Fenlon, Claire Hulme, Christine M May, Carl R May, Emma Ream, Alison Richardson, Peter W F Smith, Lucy Yardley, Claire Foster
Improving stroke prevention in patients with atrial fibrillation
Derk L Arts, Ameen Abu-Hanna, Harry R Büller, Ron JG Peters, Saeid Eslami, Henk CPM van Weert
Renal sympathetic denervation versus antiarrhythmic drugs for drug-resistant hypertension and symptomatic atrial fibrillation (RSDforAF) trial: study protocol for a randomized controlled trial
Min Qiu, Yuehui Yin, Qijun Shan
Log in and breathe out: efficacy and cost-effectiveness of an online sleep training for teachers affected by work-related strain - study protocol for a randomized controlled trial
Hanne Thiart, Dirk Lehr, David Daniel Ebert, Bernhard Sieland, Matthias Berking, Heleen Riper
Effectiveness of acupuncture intervention for neck pain caused by cervical spondylosis: study protocol for a randomized controlled trial
Qinghui Que, Xiaode Ye, Quangui Su, Yan Weng, Jianfeng Chu, Lijuan Mei, Wenwen Huang, Renhui Lu, Guohua Zheng
Telehealth system (e-CUIDATE) to improve quality of life in breast cancer survivors: rationale and study protocol for a randomized clinical trial
Noelia Galiano-Castillo, Angelica Ariza-García, Irene Cantarero-Villanueva, Carolina Fernández-Lao, Lourdes Díaz-Rodríguez, Marta Legerén-Alvarez, Carmen Sánchez-Salado, Rosario Del-Moral-Avila, Manuel Arroyo-Morales
Assessing the effectiveness and cost effectiveness of subcutaneous nerve stimulation in patients with predominant back pain due to failed back surgery syndrome (SubQStim study): study protocol for a multicenter randomized controlled trial
Sam Eldabe, Michael Kern, Wilco Peul, Colin Green, Kristi Winterfeldt, Rod S Taylor
Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial
Federica Pallavicini, Andrea Gaggioli, Simona Raspelli, Pietro Cipresso, Silvia Serino, Cinzia Vigna, Alessandra Grassi, Luca Morganti, Margherita Baruffi, Brenda Wiederhold, Giuseppe Riva
The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial
Zhishun Liu, Jia Liu, Ye Zhao, Yuying Cai, Liyun He, Huanfang Xu, Xiaohua Zhou, Shiyan Yan, Lixing Lao, Baoyan Liu
Auto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ): study protocol for a randomized controlled trial
David J Berlowitz, Najib Ayas, Maree Barnes, Douglas J Brown, Peter A Cistulli, Tim Geraghty, Alison Graham, Gerard A Kennedy, Bonsan Bonne Lee, Meg Morris, Fergal O’Donoghue, Peter D Rochford, Jack Ross, Balraj Singhal, Jo Spong, Brooke Wadsworth, Robert J Pierce
The ARIQUELI study: potentiation of quetiapine in bipolar I nonresponders with lithium versus aripiprazole
Giovani Missio, Doris Hupfeld Moreno, Fernando Fernandes, Danielle Soares Bio, Márcio Gehardt Soeiro-de-Souza, Domingos Rodrigues dos Santos Jr, Denise Petresco David, Luis Felipe Costa, Frederico Navas Demétrio, Ricardo Alberto Moreno
Lessons learnt during a complex, multicentre cluster randomised controlled trial: the ProAct65+ trial
Zoe Stevens, Hannah Carpenter, Sheena Gawler, Carolyn Belcher, Deborah Haworth, Denise Kendrick, Richard Morris, Tahir Masud, Dawn A Skelton, Steve Iliffe
Effects of probiotics in patients with diabetes mellitus type 2: study protocol for a randomized, double-blind, placebo-controlled trial
Majed S Alokail, Shaun Sabico, Yousef Al-Saleh, Nasser M Al-Daghri, Khalid M Alkharfy, Paul M Vanhoutte, Philip G McTernan
Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial
Jennica Platt, Nancy Baxter, Jennifer Jones, Kelly Metcalfe, Natalie Causarano, Stefan OP Hofer, Anne ONeill, Terry Cheng, Elizabeth Starenkyj, Toni Zhong
The effectiveness of Multidimensional Treatment Foster Care for Preschoolers (MTFC-P) for young children with severe behavioral disturbances: study protocol for a randomized controlled trial
Caroline S Jonkman, Carlo Schuengel, Robert Lindeboom, Mirjam Oosterman, Frits Boer, Ramon JL Lindauer
The impact of supported telemetric monitoring in people with type 2 diabetes: study protocol for a randomised controlled trial
Sarah Wild, Janet Hanley, Stephanie Lewis, John McKnight, Lucy McCloughan, Paul Padfield, Mary Paterson, Hilary Pinnock, Brian McKinstry
Evaluation of the acoustic coordinated reset (CR ®) neuromodulation therapy for tinnitus: study protocol for a double-blind randomized placebo-controlled trial
Derek J Hoare, Robert H Pierzycki, Holly Thomas, David McAlpine, Deborah A Hall
Lifestyle referral assessment in an acute cardiology setting: study protocol for a randomized controlled feasibility trial
Kate M Hill, Rebecca EA Walwyn, Diana C Camidge, David M Meads, Jenni Y Murray, Greg Reynolds, Amanda J Farrin, Allan O House
Evaluation and implementation of graded in vivo exposure for chronic low back pain in a German outpatient setting: a study protocol of a randomized controlled trial
Jenny Riecke, Sebastian Holzapfel, Winfried Rief, Julia Anna Glombiewski
The effect of nebulized salbutamol or isotonic saline on exercise-induced bronchoconstriction in elite skaters following a 1,500-meter race: study protocol for a randomized controlled trial
Jean MM Driessen, Margryt Gerritsma, Jaap Westbroek, Nick HT ten Hacken, Frans HC de Jongh
PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial
Stephanie Mathieson, Christopher G Maher, Andrew J McLachlan, Jane Latimer, Bart W Koes, Mark J Hancock, Ian Harris, Richard O Day, Justin Pik, Stephen Jan, Laurent Billot, Chung-Wei Christine Lin
Hydroxychloroquine effectiveness in reducing symptoms of hand osteoarthritis (HERO): study protocol for a randomized controlled trial
Sarah R Kingsbury, Puvan Tharmanathan, Joy Adamson, Nigel K Arden, Fraser Birrell, Sarah Cockayne, John Dickson, Michael Doherty, Krysia S Dziedzic, Andrew Grainger, Catherine E Hewitt, Terence W O’Neill, David L Scott, Tonia L Vincent, Richard J Wakefield, Fiona E Watt, David J Torgerson, Philip G Conaghan
MOMENT – Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey
Nicola L Harman, Iain A Bruce, Peter Callery, Stephanie Tierney, Mohammad Owaise Sharif, Kevin O’Brien, Paula R Williamson
RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial
Duncan Edwards, Kate Fletcher, Rachel Deller, Richard McManus, Daniel Lasserson, Matthew Giles, Don Sims, John Norrie, Graham McGuire, Simon Cohn, Fiona Whittle, Vikki Hobbs, Christopher Weir, Jonathan Mant
Value of information: interim analysis of a randomized, controlled trial of goal-directed hemodynamic treatment for aged patients
Erzsebet Bartha, Thomas Davidson, Thor-Henrik Brodtkorb, Per Carlsson, Sigridur Kalman
The PICHFORK (Pain InCHildren Fentanyl OR Ketamine) trial comparing the efficacy of intranasal ketamine and fentanyl in the relief of moderate to severe pain in children with limb injuries: study protocol for a randomized controlled trial
Andis Graudins, Robert Meek, Diana Egerton-Warburton, Robert Seith, Trentham Furness, Rose Chapman
An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness
Jane Barlow, Sukhdev Sembi, Frances Gardner, Geraldine Macdonald, Stavros Petrou, Helen Parsons, Paul Harnett, Sharon Dawe
An explanatory randomised placebo controlled trial of levothyroxine supplementation for babies born <28 weeks’ gestation: results of the TIPIT trial
Sze M Ng, Mark A Turner, Carrol Gamble, Mohammed Didi, Suresh Victor, Donal Manning, Paul Settle, Richa Gupta, Paul Newland, Alan Michael Weindling
'In situ simulation' versus 'off site simulation' in obstetric emergencies and their effect on knowledge, safety attitudes, team performance, stress, and motivation: study protocol for a randomized controlled trial
Jette Led Sørensen, Cees Van der Vleuten, Jane Lindschou, Christian Gluud, Doris Østergaard, Vicki LeBlanc, Marianne Johansen, Kim Ekelund, Charlotte Krebs Albrechtsen, Berit Woetman Pedersen, Hanne Kjærgaard, Pia Weikop, Bent Ottesen
Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial
Brennan C Kahan, Vipul Jairath, Michael F Murphy, Caroline J Doré
An educational intervention to reduce pain and improve pain management for Malawian people living with HIV/AIDS and their family carers: study protocol for a randomised controlled trial
Kennedy Nkhoma, Jane Seymour, Antony Arthur
The postcard intervention against depression among community-dwelling older adults: study protocol for a randomized controlled trial
Hissei Imai, Toshiaki A Furukawa, Kiyohito Okumiya, Taizo Wada, Eriko Fukutomi, Ryota Sakamoto, Michiko Fujisawa, Yasuko Ishimoto, Yumi Kimura, Wen-ling Chen, Mire Tanaka, Kozo Matsubayashi
The effects of using cognitive behavioural therapy to improve sleep for patients with delusions and hallucinations (the BEST study): study protocol for a randomized controlled trial
Daniel Freeman, Helen Startup, Elissa Myers, Allison Harvey, John Geddes, Ly-Mee Yu, Zenobia Zaiwalla, Ramon Luengo-Fernandez, Russell Foster, Rachel Lister
Psychological advocacy toward healing (PATH): study protocol for a randomized controlled trial
Gwen Brierley, Roxane Agnew-Davies, Jayne Bailey, Maggie Evans, Morgan Fackrell, Giulia Ferrari, Sandra Hollinghurst, Louise Howard, Emma Howarth, Alice Malpass, Carol Metters, Tim J Peters, Fayeza Saeed, Lynnmarie Sardhina, Debbie Sharp, Gene S Feder
Six pairs of things to celebrate on International Clinical Trials Day
David L Sackett
Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial
Hugh MacPherson, Helen E Tilbrook, Stewart J Richmond, Karl Atkin, Kathleen Ballard, Martin Bland, Janet Eldred, Holly N Essex, Ann Hopton, Harriet Lansdown, Usman Muhammad, Steve Parrott, David Torgerson, Aniela Wenham, Julia Woodman, Ian Watt
Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial
Seunghoon Lee, Joo-Hee Kim, Kyung-Min Shin, Jung-Eun Kim, Tae-Hun Kim, Kyung-Won Kang, Minhee Lee, So-Young Jung, Mi-Suk Shin, Ae-Ran Kim, Hyo-Ju Park, Kwon-Eui Hong, Sun-Mi Choi
‘Help for Hay Fever’, a goal-focused intervention for people with intermittent allergic rhinitis, delivered in Scottish community pharmacies: study protocol for a pilot cluster randomized controlled trial
Terry Porteous, Sally Wyke, Sarah Smith, Christine Bond, Jill Francis, Amanda J Lee, Richard Lowrie, Graham Scotland, Aziz Sheikh, Mike Thomas, Lorraine Smith
Comparison of high and low intensity contact between secondary and primary care to detect people at ultra-high risk for psychosis: study protocol for a theory-based, cluster randomized controlled trial
Jesus Perez, Debra A Russo, Jan Stochl, Sarah Byford, Jorge Zimbron, Jonathan P Graffy, Michelle Painter, Tim J Croudace, Peter B Jones
Effect of berberine on insulin resistance in women with polycystic ovary syndrome: study protocol for a randomized multicenter controlled trial
Yan Li, Hongli Ma, Yuehui Zhang, Hongying Kuang, Ernest Hung Yu Ng, Lihui Hou, Xiaoke Wu
Effectiveness of a web-based intervention for injured claimants: a randomized controlled trial
Nieke A Elbers, Arno J Akkermans, Pim Cuijpers, David J Bruinvels
A phase 3 tRial comparing capecitabinE in combination with SorafenIb or pLacebo for treatment of locally advanced or metastatIc HER2-Negative breast CancEr (the RESILIENCE study): study protocol for a randomized controlled trial
José Baselga, Frederico Costa, Henry Gomez, Clifford A Hudis, Bernardo Rapoport, Henri Roche, Lee S Schwartzberg, Oana Petrenciuc, Minghua Shan, William J Gradishar
‘Huang Qi Elixir’ for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial
Xiang Tu, Fang Liu, James B Jordan, Xue Feng Ye, Ping Fu, Fei Wang, Sen Zhong
Involving service users in trials: developing a standard operating procedure
Bridie Angela Evans, Emma Bedson, Philip Bell, Hayley Hutchings, Lesley Lowes, David Rea, Anne Seagrove, Stefan Siebert, Graham Smith, Helen Snooks, Marie Thomas, Kym Thorne, Ian Russell
A cognitive-behavioral intervention for emotion regulation in adults with high-functioning autism spectrum disorders: study protocol for a randomized controlled trial
Miho Kuroda, Yuki Kawakubo, Hitoshi Kuwabara, Kazuhito Yokoyama, Yukiko Kano, Yoko Kamio
Effects of Anma massage therapy (Japanese massage) for gynecological cancer survivors: study protocol for a randomized controlled trial
Nozomi Donoyama, Toyomi Satoh, Tetsutaro Hamano
The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial
Erik JRJ van der Hoeven, Wouter J Schonewille, Jan Albert Vos, Ale Algra, Heinrich J Audebert, Eivind Berge, Alfonso Ciccone, Mikael Mazighi, Patrik Michel, Keith W Muir, Víctor Obach, Volker Puetz, Cristanne AC Wijman, Andrea Zini, Jaap L Kappelle
Three-dimensional evaluation of postoperative swelling in treatment of zygomatic bone fractures using two different cooling therapy methods: a randomized, observer-blind, prospective study
Ali Modabber, Madiha Rana, Alireza Ghassemi, Marcus Gerressen, Nils-Claudius Gellrich, Frank Hölzle, Majeed Rana
Effect of oral sodium bicarbonate supplementation on progression of chronic kidney disease in patients with chronic metabolic acidosis: study protocol for a randomized controlled trial (SoBic-Study)
Martina Gaggl, Daniel Cejka, Max Plischke, Georg Heinze, Melanie Fraunschiel, Alice Schmidt, Walter H Hörl, Gere Sunder-Plassmann
Alternative Imaging Modalities in Ischemic Heart Failure (AIMI-HF) IMAGE HF Project I-A: study protocol for a randomized controlled trial
Eileen O’Meara, Lisa M Mielniczuk, George A Wells, Robert A deKemp, Ran Klein, Doug Coyle, Brian Mc Ardle, Ian Paterson, James A White, Malcolm Arnold, Matthias G Friedrich, Eric Larose, Alexander Dick, Benjamin Chow, Carole Dennie, Haissam Haddad, Terrence Ruddy, Heikki Ukkonen, Gerald Wisenberg, Bernard Cantin, Philippe Pibarot, Michael Freeman, Eric Turcotte, Kim Connelly, James Clarke, Kathryn Williams, Normand Racine, Linda Garrard, Jean-Claude Tardif, Jean DaSilva, Juhani Knuuti, Rob Beanlands
Brain imaging predictors and the international study to predict optimized treatment for depression: study protocol for a randomized controlled trial
Stuart M Grieve, Mayuresh S Korgaonkar, Amit Etkin, Anthony Harris, Stephen H Koslow, Stephen Wisniewski, Alan F Schatzberg, Charles B Nemeroff, Evian Gordon, Leanne M Williams
Evaluation of effect of low-level laser therapy on adolescents with temporomandibular disorder: study protocol for a randomized controlled trial
Camila Haddad Leal de Godoy, Paula Fernanda da Costa Silva, Deise Sales de Araujo, Lara Jansiski Motta, Daniela Aparecida Biasotto-Gonzalez, Fabiano Politti, Raquel Agnelli Mesquita-Ferrari, Kristianne Porta Santos Fernandes, Regiane Albertini, Sandra Kalil Bussadori
A randomized controlled trial of eicosapentaenoic acid and/or aspirin for colorectal adenoma prevention during colonoscopic surveillance in the NHS Bowel Cancer Screening Programme (The seAFOod Polyp Prevention Trial): study protocol for a randomized controlled trial
Mark A Hull, Anna C Sandell, Alan A Montgomery, Richard FA Logan, Gayle M Clifford, Colin J Rees, Paul M Loadman, Diane Whitham
The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial
Karen M Devries, Elizabeth Allen, Jennifer C Child, Eddy Walakira, Jenny Parkes, Diana Elbourne, Charlotte Watts, Dipak Naker
Deep brain stimulation of the ventral striatum/anterior limb of the internal capsule in thalamic pain syndrome: study protocol for a pilot randomized controlled trial
Ela B Plow, Donald A Malone Jr, Andre Machado
Developing a reporting guideline for social and psychological intervention trials
Evan Mayo-Wilson, Sean Grant, Sally Hopewell, Geraldine Macdonald, David Moher, Paul Montgomery
It’s plain and simple: transparency is good for science and in the public interest
Simon Denegri, Helene Faure
Protocol for assessing the hypotensive effect of evening administration of acetylsalicylic acid: study protocol for a randomized, cross-over controlled trial
Mª Victoria Ruíz-Arzalluz, Mª Cruz Gómez Fernández, Natalia Burgos-Alonso, Ernest Vinyoles, Ricardo San Vicente Blanco, Gonzalo Grandes
Effectiveness of scalpel debridement for painful plantar calluses in older people: a randomized trial
Karl B Landorf, Adam Morrow, Martin J Spink, Chelsey L Nash, Anna Novak, Julia Potter, Hylton B Menz
Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI
Sean A Coady, Elizabeth Wagner
Effects of exercise and diet interventions on obesity-related sleep disorders in men: study protocol for a randomized controlled trial
Xiao Tan, Antti Saarinen, Tuija M Mikkola, Jarkko Tenhunen, Samu Martinmäki, Aki Rahikainen, Shumei Cheng, Niklas Eklund, Satu Pekkala, Petri Wiklund, Eveliina Munukka, Xinfei Wen, Fengyu Cong, Xi Wang, Yajun Zhang, Ina Tarkka, Yining Sun, Markku Partinen, Markku Alen, Sulin Cheng
Treatment of the humeral shaft fractures - minimally invasive osteosynthesis with bridge plate versus conservative treatment with functional brace: study protocol for a randomised controlled trial
Fabio T Matsunaga, Marcel J S Tamaoki, Marcelo H Matsumoto, João B G dos Santos, Flavio Faloppa, João C Belloti
Optimal treatment for Spinal Cord Injury associated with cervical canal Stenosis (OSCIS): a study protocol for a randomized controlled trial comparing early versus delayed surgery
Hirotaka Chikuda, Hiroshi Ohtsu, Toru Ogata, Shurei Sugita, Masahiko Sumitani, Yurie Koyama, Morio Matsumoto, Yoshiaki Toyama
Consent, including advanced consent, of older adults to research in care homes: a qualitative study of stakeholders’ views in South Wales
Fiona Wood, Hayley Prout, Antony Bayer, Donna Duncan, Jacqueline Nuttall, Kerenza Hood, Christopher C Butler
Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial
Collins C Iwuji, Joanna Orne-Gliemann, Frank Tanser, Sylvie Boyer, Richard J Lessells, France Lert, John Imrie, Till Bärnighausen, Claire Rekacewicz, Brigitte Bazin, Marie-Louise Newell, François Dabis
IDEAS for a healthy baby - reducing disparities in use of publicly reported quality data: study protocol for a randomized controlled trial
Sarah L Goff, Penelope S Pekow, Katharine O White, Tara Lagu, Kathleen M Mazor, Peter K Lindenauer
Reversal of the neurological deficit in acute stroke with the signal of efficacy trial of auto-BPAP to limit damage from suspected sleep apnea (Reverse-STEAL): study protocol for a randomized controlled trial
Jessica Kepplinger, Kristian Barlinn, Stanislava Kolieskova, Reza Bavarsad Shahripour, Lars-Peder Pallesen, Wiebke Schrempf, Xina Graehlert, Uta Schwanebeck, April Sisson, Charlotte Zerna, Volker Puetz, Heinz Reichmann, Karen C Albright, Anne W Alexandrov, Milan Vosko, Robert Mikulik, Ulf Bodechtel, Andrei V Alexandrov
Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial
Joo-Hee Kim, Eun-Jung Kim, Byung-Kwan Seo, Sanghun Lee, Seunghoon Lee, So-Young Jung, Min-Hee Lee, Ae-Ran Kim, Hyo-Ju Park, Mi-Suk Shin, Sun-Mi Choi
Use of dexmedetomidine for prophylactic analgesia and sedation in delayed extubation patients after craniotomy: a study protocol and statistical analysis plan for a randomized controlled trial
Li-Hong Zhao, Zhong-Hua Shi, Ning-Ning Yin, Jian-Xin Zhou
Comparison of mailed invitation strategies to improve fecal occult blood test participation in men: protocol for a randomized controlled trial
Amy Duncan, Ian Zajac, Ingrid Flight, Benjamin JR Stewart, Carlene Wilson, Deborah Turnbull
PACE – the first placebo controlled trial of paracetamol for acute low back pain: statistical analysis plan
Christopher M Williams, Chris G Maher, Jane Latimer, Andrew J McLachlan, Mark J Hancock, Richard O Day, Laurent Billot, Chung-Wei Christine Lin
Effect of periodontal treatment on the clinical parameters of patients with rheumatoid arthritis: study protocol of the randomized, controlled ESPERA trial
Paul Monsarrat, Jean-Noël Vergnes, Alain Cantagrel, Nadège Algans, Sarah Cousty, Philippe Kémoun, Caroline Bertrand, Elise Arrivé, Christophe Bou, Cyril Sédarat, Thierry Schaeverbeke, Cathy Nabet, Michel Sixou
Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group
Menno Pradhan, Sally A Brinkman, Amanda Beatty, Amelia Maika, Elan Satriawan, Joppe de Ree, Amer Hasan
A self-management program for employees with complaints of the arm, neck, or shoulder (CANS): study protocol for a randomized controlled trial
Nathan Hutting, J Bart Staal, Yvonne F Heerkens, Josephine A Engels, Maria WG Nijhuis-van der Sanden
Evaluating a nurse-led survivorship care package (SurvivorCare) for bowel cancer survivors: study protocol for a randomized controlled trial
Michael Jefford, Sanchia Aranda, Karla Gough, Kerryann Lotfi-Jam, Phyllis Butow, Mei Krishnasamy, Jane Young, Jo Phipps-Nelson, Lahiru Russell, Dorothy King, Penelope Schofield
Does regional compared to local anaesthesia influence outcome after arteriovenous fistula creation?
Alan James Robert Macfarlane, Rachel Joyce Kearns, Emma Aitken, John Kinsella, Marc James Clancy
Pilot study of a social network intervention for heroin users in opiate substitution treatment: study protocol for a randomized controlled trial
Edward Day, Alex Copello, Jennifer L Seddon, Marilyn Christie, Deborah Bamber, Charlotte Powell, Sanju George, Andrew Ball, Emma Frew, Nicholas Freemantle
Effectiveness of two antifolate prophylactic strategies against malaria in HIV-positive pregnant women in Bangui, Central African Republic: study protocol for a randomized controlled trial (MACOMBA)
Alexandre Manirakiza, Abdoulaye Sepou, Eugène Serdouma, Samuel Gondje, Ghislain Géraud Banthas Bata, Sandrine Moussa, Aude Boulay, Jean Methode Moyen, Olga Sakanga, Lenaig Le-Fouler, Mirdad Kazanji, Muriel Vray
Transcranial pulsed electromagnetic fields for multiple chemical sensitivity: study protocol for a randomized, double-blind, placebo-controlled trial
Marie Thi Dao Tran, Sine Skovbjerg, Lars Arendt-Nielsen, Karl Bang Christensen, Jesper Elberling
Dexamethasone reduces emesis after major gastrointestinal surgery (DREAMS)
Emma Hamilton, Reena Ravikumar, David Bartlett, Elizabeth Hepburn, Mei-Ju Hwang, Nazzia Mirza, Sandeep S Bahia, Anthony Wilkey, Helen Bodenham Chilton, Kelly Handley, Laura Magill, Dion Morton
Lessons learned from the conduct of a multisite cluster randomized practical trial of decision aids in rural and suburban primary care practices
Kari L Ruud, Annie LeBlanc, Rebecca J Mullan, Laurie J Pencille, Kristina Tiedje, Megan E Branda, Holly K Van Houten, Sara R Heim, Margary Kurland, Nilay D Shah, Barbara P Yawn, Victor M Montori
Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial)
Christine Fink, Markus K Diener, Thomas Bruckner, Gisela Müller, Lisa Paulsen, Monika Keller, Markus W Büchler, Phillip Knebel
Combination of inositol and alpha lipoic acid in metabolic syndrome-affected women: a randomized placebo-controlled trial
Immacolata Capasso, Emanuela Esposito, Nicola Maurea, Maurizio Montella, Anna Crispo, Michelino De Laurentiis, Massimiliano D’Aiuto, Giuseppe Frasci, Gerardo Botti, Maria Grimaldi, Ernesta Cavalcanti, Giuseppe Esposito, Alfredo Fucito, Giuseppe Brillante, Giuseppe D’Aiuto, Gennaro Ciliberto
Evaluation of multisystemic therapy pilot services in the Systemic Therapy for At Risk Teens (START) trial: study protocol for a randomised controlled trial
Peter Fonagy, Stephen Butler, Ian Goodyer, David Cottrell, Stephen Scott, Stephen Pilling, Ivan Eisler, Peter Fuggle, Abdullah Kraam, Sarah Byford, James Wason, Rachel Haley
Reporting characteristics of non-primary publications of results of randomized trials: a cross-sectional review
Sally Hopewell, Gary S Collins, Allison Hirst, Shona Kirtley, Abdelouahid Tajar, Stephen Gerry, Douglas G Altman
Evaluation of two prevention programs ‘Early Steps’ and ‘Faustlos’ in daycare centers with children at risk: the study protocol of a cluster randomized controlled trial
Katrin Luise Laezer, Marianne Leuzinger-Bohleber, Bernhard Rüger, Tamara Fischmann
Composite versus conventional coronary artery bypass grafting strategy for the anterolateral territory: study protocol for a randomized controlled trial
Ariane Drouin, Nicolas Noiseux, Carl Chartrand-Lefebvre, Gilles Soulez, Samer Mansour, Jan-Alexis Tremblay, Fadi Basile, Ignacio Prieto, Louis-Mathieu Stevens
HIV prevention in favour of the choice-disabled in southern Africa: study protocol for a randomised controlled trial
Neil Andersson, Anne Cockcroft, Lehana Thabane, Nobantu Marokoane, Ditiro Laetsang, Mokgweetsi Masisi
Effect of beraprost sodium on arterial stiffness in patients with type 2 diabetic nephropathy
Ki Young Na, Dong Ki Kim, Sung Gyun Kim, Young-Ki Lee, Chun Soo Lim
WSG ADAPT – adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer: study protocol for a prospective, multi-center, controlled, non-blinded, randomized, investigator initiated phase II/III trial
Daniel Hofmann, Ulrike Nitz, Oleg Gluz, Ronald E Kates, Timo Schinkoethe, Peter Staib, Nadia Harbeck
The effectiveness of aerobic training, cognitive behavioural therapy, and energy conservation management in treating MS-related fatigue: the design of the TREFAMS-ACE programme
Heleen Beckerman, Lyan JM Blikman, Martin Heine, Arjan Malekzadeh, Charlotte E Teunissen, Johannes BJ Bussmann, Gert Kwakkel, Jetty van Meeteren, Vincent de Groot
Steroids or pentoxifylline for alcoholic hepatitis (STOPAH): study protocol for a randomised controlled trial
Ewan Forrest, Jane Mellor, Louise Stanton, Megan Bowers, Priscilla Ryder, Andrew Austin, Christopher Day, Dermot Gleeson, John O’Grady, Steven Masson, Anne McCune, David Patch, Paul Richardson, Paul Roderick, Stephen Ryder, Mark Wright, Mark Thursz
Comparing single-site with multisite rTMS for the treatment of chronic tinnitus – clinical effects and neuroscientific insights: study protocol for a randomized controlled trial
Astrid Lehner, Martin Schecklmann, Peter M Kreuzer, Timm B Poeppl, Rainer Rupprecht, Berthold Langguth
Dose-related effects of vitamin D on immune responses in patients with clinically isolated syndrome and healthy control participants: study protocol for an exploratory randomized double- blind placebo-controlled trial
Karen O’Connell, Siobhan Kelly, Katie Kinsella, Sinead Jordan, Orla Kenny, David Murphy, Eric Heffernan, Risteard O’Laoide, Donal O’Shea, Carmel McKenna, Lorraine Cassidy, Jean Fletcher, Cathal Walsh, Jennifer Brady, Christopher McGuigan, Niall Tubridy, Michael Hutchinson
Study of therapeutic hypothermia (32 to 35°C) for intracranial pressure reduction after traumatic brain injury (the Eurotherm3235Trial): outcome of the pilot phase of the trial
Peter J D Andrews, Louise H Sinclair, Bridget Harris, Melissa J Baldwin, Claire G Battison, Jonathan K J Rhodes, Gordon Murray, Daniel De Backer
A culturally adapted lifestyle intervention addressing a Middle Eastern immigrant population at risk of diabetes, the MEDIM (impact of Migration and Ethnicity on Diabetes In Malmö): study protocol for a randomized controlled trial
Sanjib Saha, Matti Leijon, Ulf Gerdtham, Kristina Sundquist, Jan Sundquist, Daniel Arvidsson, Louise Bennet
The effect of periodontal therapy on C-reactive protein, endothelial function, lipids and proinflammatory biomarkers in patients with stable coronary artery disease: study protocol for a randomized controlled trial
Marco Aurélio Lumertz Saffi, Mariana Vargas Furtado, Márlon Munhoz Montenegro, Ingrid Webb Josephson Ribeiro, Cassio Kampits, Eneida Rejane Rabelo-Silva, Carisi Anne Polanczyk, Cassiano Kuchenbecker Rösing, Alex Nogueira Haas
Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial
Hélène Fron Chabouis, Caroline Prot, Cyrille Fonteneau, Karim Nasr, Olivier Chabreron, Stéphane Cazier, Christian Moussally, Alexandre Gaucher, Inès Khabthani Ben Jaballah, Renaud Boyer, Jean-François Leforestier, Aurore Caumont-Prim, Florence Chemla, Louis Maman, Cathy Nabet, Jean-Pierre Attal
Does a 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine prevent respiratory exacerbations in children with recurrent protracted bacterial bronchitis, chronic suppurative lung disease and bronchiectasis: protocol for a randomised controlled trial
Kerry-Ann F O’Grady, Keith Grimwood, Allan Cripps, Edward K Mulholland, Peter Morris, Paul J Torzillo, Nicholas Wood, Heidi Smith-Vaughan, Amber Revell, Andrew Wilson, Peter Van Asperen, Peter Richmond, Ruth Thornton, Sheree Rablin, Anne B Chang
A novel community-based study to address disparities in hypertension and colorectal cancer: a study protocol for a randomized control trial
Joseph Ravenell, Hayley Thompson, Helen Cole, Jordan Plumhoff, Gia Cobb, Lola Afolabi, Carla Boutin-Foster, Martin Wells, Marian Scott, Gbenga Ogedegbe
Study to assess the effect of a structured communication approach on quality of life in secure mental health settings (Comquol): study protocol for a pilot cluster randomized trial
Douglas MacInnes, Catherine Kinane, Dominic Beer, Janet Parrott, Tom Craig, Sandra Eldridge, Ian Marsh, Joanna Krotofil, Stefan Priebe
Hospital-admitted COPD patients treated at home using telemedicine technology in The Virtual Hospital Trial: methods of a randomized effectiveness trial
Anna Svarre Jakobsen, Lars C Laursen, Birte Østergaard, Susan Rydahl-Hansen, Klaus V Phanareth
Adolescent Cancer Education (ACE) to increase adolescent and parent cancer awareness and communication: study protocol for a cluster randomised controlled trial
Richard G Kyle, Iona Macmillan, Petra Rauchhaus, Ronan O’Carroll, Richard D Neal, Liz Forbat, Sally Haw, Gill Hubbard
Goal-setting intervention in patients with active asthma: protocol for a pilot cluster-randomised controlled trial
Gaylor Hoskins, Purva Abhyankar, Anne D Taylor, Edward Duncan, Aziz Sheikh, Hilary Pinnock, Marjon van der Pol, Peter T Donnan, Brian Williams
Assessment of Truflex™ articulating stylet versus conventional rigid Portex™ stylet as an intubation guide with the D-blade of C-Mac™ videolaryngoscope during elective tracheal intubation: study protocol for a randomized controlled trial
Aida Al-Qasmi, Wafa Al-Alawi, Azharuddin Mohammed Malik, Rashid Manzoor Khan, Naresh Kaul
Vitamin D supplementation in older people (VDOP): Study protocol for a randomised controlled intervention trial with monthly oral dosing with 12,000 IU, 24,000 IU or 48,000 IU of vitamin D3
Inez Schoenmakers, Roger M Francis, Elaine McColl, Thomas Chadwick, Gail R Goldberg, Christine Harle, Alison Yarnall, Jennifer Wilkinson, Jennie Parker, Ann Prentice, Terence Aspray
Detailed statistical analysis plan for the target temperature management after out-of-hospital cardiac arrest trial
Niklas Nielsen, Per Winkel, Tobias Cronberg, David Erlinge, Hans Friberg, Yvan Gasche, Christian Hassager, Janneke Horn, Jan Hovdenes, Jesper Kjaergaard, Michael Kuiper, Tommaso Pellis, Pascal Stammet, Michael Wanscher, Matt P Wise, Anders Åneman, Jørn Wetterslev
Nitrates and bone turnover (NABT) - trial to select the best nitrate preparation: study protocol for a randomized controlled trial
Roxana C Bucur, Lauren S Reid, Celeste J Hamilton, Steven R Cummings, Sophie A Jamal
The effect of intravenous iron on postoperative transfusion requirements in hip fracture patients: study protocol for a randomized controlled trial
Martin Rowlands, Daren P Forward, Opinder Sahota, Iain K Moppett
Effectiveness of a cognitive behavioural therapy-based rehabilitation programme (Progressive Goal Attainment Program) for patients who are work-disabled due to back pain: study protocol for a multicentre randomised controlled trial
Miriam N Raftery, Andrew W Murphy, Eamon O’Shea, John Newell, Brian E McGuire
Intensive exercise program after spinal cord injury (“Full-On”): study protocol for a randomized controlled trial
Mary P Galea, Sarah A Dunlop, Glen M Davis, Andrew Nunn, Timothy Geraghty, Ya-seng (Arthur) Hsueh, Leonid Churilov
Total or Partial Knee Arthroplasty Trial - TOPKAT: study protocol for a randomised controlled trial
David Beard, Andrew Price, Jonathan Cook, Ray Fitzpatrick, Andrew Carr, Marion Campbell, Helen Doll, Helen Campbell, Nigel Arden, Cushla Cooper, Loretta Davies, David Murray
Short-term psychotherapeutic treatment in adolescents engaging in non-suicidal self-injury: a randomized controlled trial
Gloria Fischer, Romuald Brunner, Peter Parzer, Franz Resch, Michael Kaess
Muslim communities learning about second-hand smoke (MCLASS): study protocol for a pilot cluster randomised controlled trial
Hannah Ainsworth, Sarwat Shah, Faraz Ahmed, Amanda Amos, Ian Cameron, Caroline Fairhurst, Rebecca King, Ghazala Mir, Steve Parrott, Aziz Sheikh, David Torgerson, Heather Thomson, Kamran Siddiqi
Auricular acupuncture for prehypertension and stage 1 hypertension: study protocol for a pilot multicentre randomised controlled trial
Joo-Hee Kim, Hyun Jung Jung, Tae-Hun Kim, Seunghoon Lee, Jung-Eun Kim, Kyung-Won Kang, So-Young Jung, Ae-Ran Kim, Hyo-Ju Park, Mi-Suk Shin, Kyung-Min Shin, Hee-Jung Jung, Seung-Deok Lee, Kwon-Eui Hong, Sun-Mi Choi
Psychodynamic Motivation and Training program (PMT) for the secondary prevention in patients with stable coronary heart disease: study protocol for a randomized controlled trial of feasibility and effects
Matthias Michal, Perikles Simon, Tommaso Gori, Jochem König, Philipp S Wild, Jörg Wiltink, Suzan Tug, Björn Sterzing, Josef Unterrainer, Thomas Münzel, Manfred E Beutel
Impact of retreatment with an artemisinin-based combination on malaria incidence and its potential selection of resistant strains: study protocol for a randomized controlled clinical trial
Hypolite Muhindo Mavoko, Carolyn Nabasumba, Halidou Tinto, Umberto D’Alessandro, Martin Peter Grobusch, Pascal Lutumba, Jean-Pierre Van Geertruyden
TRialing individualized interventions to prevent functional decline in at-risk older adults (TRIIFL): study protocol for a randomized controlled trial nested in a longitudinal observational study
Karen Grimmer, Julie Luker, Kate Beaton, Saravana Kumar, Alan Crockett, Kay Price
Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial
Kristen L Hollands, Trudy Pelton, Andrew Wimperis, Diane Whitham, Sue Jowett, Catherine Sackley, Wing Alan, Paulette van Vliet
Predictive risk stratification model: a progressive cluster-randomised trial in chronic conditions management (PRISMATIC) research protocol
Hayley A Hutchings, Bridie A Evans, Deborah Fitzsimmons, Jane Harrison, Martin Heaven, Peter Huxley, Mark-Rhys Kingston, Leo Lewis, Ceri Phillips, Alison Porter, Ian T Russell, Bernadette Sewell, Daniel Warm, Alan Watkins, Helen A Snooks
Lifestyle Matters for maintenance of health and wellbeing in people aged 65 years and over: study protocol for a randomised controlled trial
Kirsty Sprange, Gail A Mountain, John Brazier, Sarah P Cook, Claire Craig, Daniel Hind, Stephen J Walters, Gill Windle, Robert Woods, Anju D Keetharuth, Tim Chater, Kath Horner
The cost-effectiveness of a family meetings intervention to prevent depression and anxiety in family caregivers of patients with dementia: a randomized trial
Karlijn J Joling, Judith E Bosmans, Harm W J van Marwijk, Henriëtte E van der Horst, Philip Scheltens, Janet L MacNeil Vroomen, Hein P J van Hout
Managing executive dysfunction following acquired brain injury and stroke using an ecologically valid rehabilitation approach: a study protocol for a randomized, controlled trial
Deirdre R Dawson, Nicole D Anderson, Malcolm A Binns, Carolina Bottari, Thecla Damianakis, Anne Hunt, Helene J Polatajko, Merrick Zwarenstein
LIHNCS - Lugol’s iodine in head and neck cancer surgery: a multicentre, randomised controlled trial assessing the effectiveness of Lugol’s iodine to assist excision of moderate dysplasia, severe dysplasia and carcinoma in situ at mucosal resection margins of oral and oropharyngeal squamous cell carcinoma: study protocol for a randomised controlled trial
James A McCaul, James A Cymerman, Stuart Hislop, Chris McConkey, Jeremy McMahon, Hisham Mehanna, Richard Shaw, David N Sutton, Janet Dunn
A randomized blinded controlled trial of mobile phone reminders on the follow-up medical care of HIV-exposed and HIV-infected children in Cameroon: study protocol (MORE CARE)
Jean Joel R Bigna, Charles Kouanfack, Jean Jacques N Noubiap, Claudia S Plottel, Sinata Koulla-Shiro
Effects of a multifaceted intervention on cardiovascular risk factors in high-risk hypertensive patients: the ESCAPE trial, a pragmatic cluster randomized trial in general practice
Denis Pouchain, Michel Lièvre, Dominique Huas, Jean-Pierre Lebeau, Vincent Renard, Eric Bruckert, Xavier Girerd, Florent Boutitie
First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse
Jacqueline Barnes, Dipti Aistrop, Elizabeth Allen, Jane Barlow, Diana Elbourne, Geraldine Macdonald, Edward Melhuish, Stavros Petrou, Joshua Pink, Claire Snowdon, Helen Spiby, Jane Stuart, Joanna Sturgess
Effect of mandibular mobilization on electromyographic signals in muscles of mastication and static balance in individuals with temporomandibular disorder: study protocol for a randomized controlled trial
Yasmin El Hage, Fabiano Politti, Dowglas F Magalhães de Sousa, Carolina Marciela Herpich, Igor Phillip dos Santos Gloria, Cid André Fidelis de Paula Gomes, Ana Paula Amaral, Nívea Cristina de Melo, Thais Correa da Silva, Eric Edmur Camargo Arruda, Cesar Ferreira Amorim, Inaê Caroline Gadotti, Tabajara Oliveira Gonzalez, Fausto Berzin, Sandra Kalil Bussadori, Marília Barbosa Santos Garcia, Bruno Roberto Borges Barbosa, Daniela Aparecida Biasotto-Gonzalez
Intravenous transplantation of mesenchymal stem cells preconditioned with early phase stroke serum: current evidence and study protocol for a randomized trial
Suk Jae Kim, Gyeong Joon Moon, Won Hyuk Chang, Yun-Hee Kim, Oh Young Bang
Cognitive-behavioral therapy for binge eating disorder in adolescents: study protocol for a randomized controlled trial
Anja Hilbert
Yukmijihwang-tang for the treatment of xerostomia in the elderly: study protocol for a randomized, double-blind, placebo-controlled, two-center trial
Gajin Han, Jae-Woo Park, Seok-Jae Ko, Jihee Son, Jongki Seon, Juyeon Kim, Seulki Kim, Inkwon Yeo, Bongha Ryu, Jinsung Kim
Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial
Aurelie Tinland, Cecile Fortanier, Vincent Girard, Christian Laval, Benjamin Videau, Pauline Rhenter, Tim Greacen, Bruno Falissard, Themis Apostolidis, Christophe Lançon, Laurent Boyer, Pascal Auquier
The efficacy and safety of electroacupuncture for women with pure stress urinary incontinence: study protocol for a multicenter randomized controlled trial
Zhishun Liu, Huanfang Xu, Yuelai Chen, Liyun He, Jia Liu, Shiyan Yan, Ruosang Du, Jiani Wu, Baoyan Liu
FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial
Annette Baumgaertner, Tanja Grewe, Wolfram Ziegler, Agnes Floel, Luise Springer, Peter Martus, Caterina Breitenstein
Effects of different information brochures on women’s decision-making regarding mammography screening: study protocol for a randomized controlled questionnaire study
Elisabeth Gummersbach, Jürgen in der Schmitten, Heinz-Harald Abholz, Karl Wegscheider, Michael Pentzek
Standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI): study protocol for a randomized controlled trial
Orla M Smith, Ron Wald, Neill KJ Adhikari, Karen Pope, Matthew A Weir, Sean M Bagshaw
QUALZICE: A QUALitative exploration of the experiences of the participants from the ZICE clinical trial (metastatic breast cancer) receiving intravenous or oral bisphosphonates
Annmarie Nelson, Debbie Fenlon, Jenny Morris, Cathy Sampson, Emily Harrop, Nick Murray, Duncan Wheatley, Kerenza Hood, Gareth Griffiths, Peter Barrett-Lee
Postoperative pain and perioperative outcomes after laparoscopic radical hysterectomy and abdominal radical hysterectomy in patients with early cervical cancer: a randomised controlled trial
Luciana Silveira Campos, Leo Francisco Limberger, Airton Tetelbom Stein, Antonio Nocchi Kalil
Land-based versus aquatic resistance therapeutic exercises for older women with sarcopenic obesity: study protocol for a randomised controlled trial
Karina Simone de Souza Vasconcelos, João Marcos Domingues Dias, Marília Caixeta de Araújo, Ana Cisalpino Pinheiro, Marcela Machado Maia, Rosângela Corrêa Dias
Does continuous endurance exercise in water elicit a higher release of ANP and BNP and a higher plasma concentration of FFAs in pre-obese and obese men than high intensity intermittent endurance exercise? – Study protocol for a randomized controlled trial
Klaus Karner-Rezek, Beat Knechtle, Matthias Fenzl, Joeri Gredig, Thomas Rosemann
Myocardial Infarction - Stress PRevention INTervention (MI-SPRINT) to reduce the incidence of posttraumatic stress after acute myocardial infarction through trauma-focused psychological counseling: study protocol for a randomized controlled trial
Rebecca Meister, Mary Princip, Jean-Paul Schmid, Ulrich Schnyder, Jürgen Barth, Hansjörg Znoj, Claudia Herbert, Roland von Känel
Outcome measures in rheumatoid arthritis randomised trials over the last 50 years
Jamie J Kirkham, Maarten Boers, Peter Tugwell, Mike Clarke, Paula R Williamson
Effectiveness and neural mechanisms associated with tDCS delivered to premotor cortex in stroke rehabilitation: study protocol for a randomized controlled trial
Ela B Plow, David A Cunningham, Erik Beall, Stephen Jones, Alexandria Wyant, Corin Bonnett, Guang H Yue, Mark Lowe, Xiao-Feng Wang, Ken Sakaie, Andre Machado
“Pre-schoolers in the playground” an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial
Sally E Barber, Cath Jackson, Shaheen Akhtar, Daniel D Bingham, Hannah Ainsworth, Catherine Hewitt, Gerry Richardson, Carolyn D Summerbell, Kate E Pickett, Helen J Moore, Ash C Routen, Claire L O’Malley, Shirley Brierley, John Wright
Feasibility intervention trial of two types of improved cookstoves in three resource-limited settings: study protocol for a randomized controlled trial
Elizabeth Klasen, J Jaime Miranda, Subarna Khatry, Diana Menya, Robert H Gilman, James M Tielsch, Caitlin Kennedy, Robert Dreibelbis, Neha Naithani, Sylvester Kimaiyo, Marilu Chiang, E Jane Carter, Charles B Sherman, Patrick N Breysse, William Checkley
Cardiovascular rehabilitation soon after stroke using feedback-controlled robotics-assisted treadmill exercise: study protocol of a randomised controlled pilot trial
Oliver Stoller, Eling D de Bruin, Corina Schuster-Amft, Matthias Schindelholz, Rob A de Bie, Kenneth J Hunt
Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial
Sophy TF Shih, Nathalie Davis-Lameloise, Edward D Janus, Carol Wildey, Vincent L Versace, Virginia Hagger, Dino Asproloupos, Sharleen O’Reilly, Paddy A Phillips, Michael Ackland, Timothy Skinner, Jeremy Oats, Rob Carter, James D Best, James A Dunbar
An Internet-based intervention for eating disorders consisting of automated computer-tailored feedback with or without supplemented frequent or infrequent support from a coach: study protocol for a randomized controlled trial
Jiska J Aardoom, Alexandra E Dingemans, Philip Spinhoven, Leona Hakkaart-van Roijen, Eric F Van Furth
Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial
Anne Barzel, Gesche Ketels, Britta Tetzlaff, Heike Krüger, Kerstin Haevernick, Anne Daubmann, Karl Wegscheider, Martin Scherer
Electro-acupuncture with different current intensities to treat functional constipation: a study protocol for a randomized controlled trial
Cui Hong Zheng, Guang Ying Huang, Xiao Hu Xu, Ying Wang, Ming Min Zhang, Wei Wang, Xiang Hong Jing, Bing Zhu
Household contact investigation for tuberculosis in Vietnam: study protocol for a cluster randomized controlled trial
Gregory J Fox, Nguyen Viet Nhung, Dinh Ngoc Sy, Warwick J Britton, Guy B Marks
Review of the registration of clinical trials in UMIN-CTR from 2 June 2005 to 1 June 2010 - focus on Japan domestic, academic clinical trials
Wentao Tang, Manabu Fukuzawa, Hirono Ishikawa, Kiichiro Tsutani, Takahiro Kiuchi
Cardiovascular disease risk reduction in rural China: a clustered randomized controlled trial in Zhejiang
Xiaolin Wei, Guanyang Zou, Weiwei Gong, Jia Yin, Yunxian Yu, John Walley, Zhitong Zhang, Rebecca King, Kun Chen, Marc Ka Chun Chong, Benny Chung Ying Zee, Su Liu, Jinling Tang, Sian Griffiths, Min Yu
Telephone-based health coaching for chronically ill patients: study protocol for a randomized controlled trial
Sarah Dwinger, Jörg Dirmaier, Lutz Herbarth, Hans-Helmut König, Matthias Eckardt, Levente Kriston, Isaac Bermejo, Martin Härter
Efficacy of in-service nutrition training for mid-level providers to improve feeding practices among HIV-positive children in Tanga, Tanzania: study protocol for a cluster randomized controlled trial
Bruno F Sunguya, Krishna C Poudel, Linda B Mlunde, David P Urassa, Masamine Jimba, Junko Yasuoka
Sustaining Transfers through Affordable Research Translation (START): study protocol to assess knowledge translation interventions in continuing care settings
Susan E Slaughter, Carole A Estabrooks, C Allyson Jones, Adrian S Wagg, Misha Eliasziw
Does telecare prolong community living in dementia? A study protocol for a pragmatic, randomised controlled trial
Iracema Leroi, John Woolham, Rebecca Gathercole, Robert Howard, Barbara Dunk, Chris Fox, John O’Brien, Andrew Bateman, Fiona Poland, Peter Bentham, Alistair Burns, Anna Davies, Kirsty Forsyth, Richard Gray, Martin Knapp, Stanton Newman, Rupert McShane, Craig Ritchie
Initiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design
Gabriela J Prutsky, Juan Pablo Domecq, Patricia J Erwin, Matthias Briel, Victor M Montori, Elie A Akl, Joerg J Meerpohl, Dirk Bassler, Stefan Schandelmaier, Stephen D Walter, Qi Zhou, Pablo Alonso Coello, Lorenzo Moja, Martin Walter, Kristian Thorlund, Paul Glasziou, Regina Kunz, Ignacio Ferreira-Gonzalez, Jason Busse, Xin Sun, Annette Kristiansen, Benjamin Kasenda, Osama Qasim-Agha, Gennaro Pagano, Hector Pardo-Hernandez, Gerard Urrutia, Mohammad Hassan Murad, Gordon Guyatt
Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial
Edward M Giesbrecht, William C Miller, Janice J Eng, Ian M Mitchell, Roberta L Woodgate, Charles H Goldsmith
Implementation of personalized self-management support using the self-management screening questionnaire SeMaS; a study protocol for a cluster randomized trial
Nathalie Eikelenboom, Jan van Lieshout, Michel Wensing, Ivo Smeele, Annelies E Jacobs
Ozurdex® (a slow-release dexamethasone implant) in proliferative vitreoretinopathy: study protocol for a randomised controlled trial
Philip J Banerjee, Catey Bunce, David G Charteris
Target dIsease-Guided placEbo-contRolled (TIGER) design: a novel method for clinical trials of acupuncture
Wenke Zheng, Hui Wang, Li Zhang, Zhaoxiang Bian, Hongcai Shang
The development of a standard training toolkit for research studies that recruit pregnant women in labour
Sara Kenyon, Jackie Sears, Hannah Reay
Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial
Jiao Chen, Ling Zhao, Hui Zheng, Ying Li, Mingxiao Yang, Xiaorong Chang, Biao Gong, Yinlan Huang, Yanqin Liu, Fanrong Liang
A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse
Carol Bugge, Brian Williams, Suzanne Hagen, Janet Logan, Cathryn Glazener, Stewart Pringle, Lesley Sinclair
Effectiveness of olive oil for the prevention of pressure ulcers caused in immobilized patients within the scope of primary health care: study protocol for a randomized controlled trial
Inmaculada Lupiáñez-Pérez, Juan Carlos Morilla-Herrera, Leovigildo Ginel-Mendoza, Francisco Javier Martín-Santos, Francisco Javier Navarro-Moya, Rafaela Pilar Sepúlveda-Guerra, Rosa Vázquez-Cerdeiros, Magdalena Cuevas-Fernández-Gallego, Isabel María Benítez-Serrano, Yolanda Lupiáñez-Pérez, José Miguel Morales-Asencio
Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial
Xue-Jun Cui, Yue-Li Sun, Sheng-Fu You, Wen Mo, Sheng Lu, Qi Shi, Yong-Jun Wang
Laparoscopic bridging vs. anatomic open reconstruction for midline abdominal hernia mesh repair [LABOR]: single-blinded, multicenter, randomized, controlled trial on long-term functional results
Cesare Stabilini, Umberto Bracale, Giusto Pignata, Marco Frascio, Marco Casaccia, Paolo Pelosi, Alessio Signori, Tommaso Testa, Gian Marco Rosa, Nicola Morelli, Rosario Fornaro, Denise Palombo, Serena Perotti, Maria Santina Bruno, Mikaela Imperatore, Carolina Righetti, Stefano Pezzato, Fabrizio Lazzara, Ezio Gianetta
The food choice at work study: effectiveness of complex workplace dietary interventions on dietary behaviours and diet-related disease risk - study protocol for a clustered controlled trial
Fiona Geaney, Jessica Scotto Di Marrazzo, Clare Kelly, Anthony P Fitzgerald, Janas M Harrington, Ann Kirby, Ken McKenzie, Birgit Greiner, Ivan J Perry
Effects of tai chi program on neuromuscular function for patients with knee osteoarthritis: study protocol for a randomized controlled trial
Xue-Qiang Wang, Ling-Yan Huang, Yu Liu, Jing-Xian Li, Xie Wu, Hai-Peng Li, Lin Wang
Effects of cognitive remediation on cognitive dysfunction in partially or fully remitted patients with bipolar disorder: study protocol for a randomized controlled trial
Kirsa M Demant, Glennie Marie Almer, Maj Vinberg, Lars Vedel Kessing, Kamilla W Miskowiak
The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan
Debbie A Lawlor, Tim J Peters, Laura D Howe, Sian M Noble, Ruth R Kipping, Russell Jago
Chinese herbal medicine (Ma Zi Ren Wan) for functional constipation: study protocol for a prospective, double-blinded, double-dummy, randomized controlled trial
Linda LD Zhong, Chung Wah Cheng, Yawen Chan, King Hong Chan, Ting Wa Lam, Xiao Rui Chen, Chi Tak Wong, Justin CY Wu, Zhao Xiang Bian
Effects of omega-3 polyunsaturated fatty acid supplementation in patients with chronic chagasic cardiomyopathy: study protocol for a randomized controlled trial
Paula S Silva, Gilberto Marcelo Sperandio da Silva, Andréa P de Souza, Claudia SA Cardoso, Cristiane A Fonseca, Patricia D Brito, Roberto M Saraiva, Pedro EA Brasil, Roberta O Pinheiro, Alejandro M Hasslocher-Moreno, Sérgio S Xavier, Andréa S Sousa
Acupuncture for patients with mild hypertension: study protocol of an open-label multicenter randomized controlled trial
Juan Li, Hui Zheng, Ling Zhao, Ying Li, Yan Zhang, Xiao-rong Chang, Rui-hui Wang, Jing Shi, Jin Cui, Yin-lan Huang, Xiang Li, Jie Chen, De-hua Li, Fan-rong Liang
Cervical auscultation in the diagnosis of oropharyngeal aspiration in children: a study protocol for a randomised controlled trial
Thuy T Frakking, Anne B Chang, Kerry-Ann F O’Grady, Katie Walker-Smith, Kelly A Weir
Vancouver At Home: pragmatic randomized trials investigating Housing First for homeless and mentally ill adults
Julian M Somers, Michelle L Patterson, Akm Moniruzzaman, Lauren Currie, Stefanie N Rezansoff, Anita Palepu, Karen Fryer
Rehabilitation for the management of knee osteoarthritis using comprehensive traditional Chinese medicine in community health centers: study protocol for a randomized controlled trial
Hu Yan, Youxin Su, Lidian Chen, Guohua Zheng, Xueyi Lin, Baojun Chen, Bihong Zhou, Qing Zhang
Is there excess mortality in women screened with mammography: a meta-analysis of non-breast cancer mortality
Sylvie Erpeldinger, Laure Fayolle, Rémy Boussageon, Marie Flori, Xavier Lainé, Alain Moreau, François Gueyffier
Comparison of error-based and errorless learning for people with severe traumatic brain injury: study protocol for a randomized control trial
Tamara Ownsworth, Jennifer Fleming, Robyn Tate, David HK Shum, Janelle Griffin, Julia Schmidt, Amanda Lane-Brown, Melissa Kendall, Mathilde Chevignard
Reducing patients’ suicide ideation through training mental health teams in the application of the Dutch multidisciplinary practice guideline on assessment and treatment of suicidal behavior: study protocol of a randomized controlled trial
Derek P de Beurs, Marieke H de Groot, Judith E Bosmans, Jos de Keijser, Jan Mokkenstorm, Bas Verwey, Erik van Duijn, Remco FP de Winter, Ad JFM Kerkhof
Spinal cord stimulation for predominant low back pain in failed back surgery syndrome: study protocol for an international multicenter randomized controlled trial (PROMISE study)
Philippe Rigoard, Mehul J Desai, Richard B North, Rod S Taylor, Lieven Annemans, Christine Greening, Ye Tan, Carine Van den Abeele, Jane Shipley, Krishna Kumar
Golden plaster for pain therapy in patients with knee osteoarthritis: study protocol for a multicenter randomized, double-blind, placebo-controlled trial
Jin-Tao Liu, De-Zhi Tang, Xiao-Feng Li, Zhi-Gang Zhang, Wan-Bo Ji, Shuai Tao, Yong-Jun Wang, Hong Jiang
A new model of integrated primary-secondary care for complex diabetes in the community: study protocol for a randomised controlled trial
Jianzhen Zhang, Letitia Burridge, Kimberley A Baxter, Maria Donald, Michele M Foster, Samantha A Hollingworth, Robert S Ware, Anthony W Russell, Claire L Jackson
Porvoo sarcopenia and nutrition trial: effects of protein supplementation on functional performance in home-dwelling sarcopenic older people - study protocol for a randomized controlled trial
Mikko P Bjorkman, Merja H Suominen, Kaisu H Pitkälä, Harriet U Finne-Soveri, Reijo S Tilvis
Effect of oral nitrates on pulse pressure and arterial elasticity in patients aged over 65 years with refractory isolated systolic hypertension: study protocol for a randomized controlled trial
Daniel Abad-Pérez, Blanca Novella-Arribas, Francisco J Rodríguez-Salvanés, Luis M Sánchez-Gómez, Iluminada García-Polo, Carmen Verge-González, Carmen Suárez-Fernández
Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings
Sylvia Dickson, Janet Logan, Suzanne Hagen, Diane Stark, Cathryn Glazener, Alison M McDonald, Gladys McPherson
Response to: Practical methods for incorporating summary time-to-event data into meta-analysis
Yu Wang, Tingting Zeng
Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial
Masahito Jimbo, Karen Kelly-Blake, Ananda Sen, Sarah T Hawley, Mack T Ruffin IV
Angiographic and clinical comparison of novel Orsiro Hybrid sirolimus-eluting stents and Resolute Integrity zotarolimus-eluting stents in all-comers with coronary artery disease (ORIENT trial): study protocol for a randomized controlled trial
Joo Myung Lee, Sang-Don Park, Sang Yup Lim, Joon-Hyung Doh, Jin Man Cho, Ki-Seok Kim, Jang-Whan Bae, Woo-Young Chung, Tae-Jin Youn
Adolescent depressive disorders and family based interventions in the family options multicenter evaluation: study protocol for a randomized controlled trial
Andrew J Lewis, Melanie D Bertino, Joanna Skewes, Lyndel Shand, Nina Borojevic, Tess Knight, Dan I Lubman, John W Toumbourou
A brief intervention for weight management in primary care: study protocol for a randomized controlled trial
Amanda Lewis, Kate Jolly, Peymane Adab, Amanda Daley, Amanda Farley, Susan Jebb, Deborah Lycett, Sarah Clarke, Anna Christian, Jing Jin, Ben Thompson, Paul Aveyard
Effects of an aquatic physical exercise program on glycemic control and perinatal outcomes of gestational diabetes: study protocol for a randomized controlled trial
José Roberto da Silva Jr, Paulo Sérgio Borges, Karine F Agra, Isabelle Albuquerque Pontes, João Guilherme Bezerra Alves
The effectiveness of Grief-Help, a cognitive behavioural treatment for prolonged grief in children: study protocol for a randomised controlled trial
Mariken Spuij, Peter Prinzie, Maja Dekovic, Jan van den Bout, Paul A Boelen
The effectiveness of a suicide prevention app for indigenous Australian youths: study protocol for a randomized controlled trial
Fiona L Shand, Rebecca Ridani, Joe Tighe, Helen Christensen
Treatment of subcutaneous abdominal wound healing impairment after surgery without fascial dehiscence by vacuum assisted closure™ (SAWHI-V.A.C.®-study) versus standard conventional wound therapy: study protocol for a randomized controlled trial
Dörthe Seidel, Rolf Lefering, Edmund AM Neugebauer
EMPIRICUS micafungin versus placebo during nosocomial sepsis in Candida multi-colonized ICU patients with multiple organ failures: study protocol for a randomized controlled trial
Jean-François Timsit, Elie Azoulay, Muriel Cornet, Jean-Pierre Gangneux, Vincent Jullien, Aurélien Vésin, Edith Schir, Michel Wolff
AUtomated Risk Assessment for Stroke in Atrial Fibrillation (AURAS-AF) - an automated software system to promote anticoagulation and reduce stroke risk: study protocol for a cluster randomised controlled trial
Tim A Holt, David A Fitzmaurice, Tom Marshall, Matthew Fay, Nadeem Qureshi, Andrew R H Dalton, F D Richard Hobbs, Daniel S Lasserson, Karen Kearley, Jenny Hislop, Jing Jin
Prevention of Decline in Cognition after Stroke Trial (PODCAST): a study protocol for a factorial randomised controlled trial of intensive versus guideline lowering of blood pressure and lipids
Daniel J Blackburn, Kailash Krishnan, Lydia Fox, Clive Ballard, Alistair Burns, Gary A Ford, Jonathan Mant, Peter Passmore, Stuart Pocock, John Reckless, Nikola Sprigg, Rob Stewart, Joanna Wardlaw, Philip MW Bath
Novel design for a phase IIa placebo-controlled, double-blind randomized withdrawal study to evaluate the safety and efficacy of CNV1014802 in patients with trigeminal neuralgia
Joanna M Zakrzewska, Joanne Palmer, Dominik A Ettlin, Mark Obermann, Gerard MP Giblin, Valerie Morisset, Simon Tate, Kevin Gunn
Comparison of three different dressings for partial thickness burns in children: study protocol for a randomised controlled trial
Emma Gee Kee, Roy M Kimble, Leila Cuttle, Kellie Stockton
A randomized controlled trial investigating the neurocognitive effects of Lacprodan® PL-20, a phospholipid-rich milk protein concentrate, in elderly participants with age-associated memory impairment: the Phospholipid Intervention for Cognitive Ageing Reversal (PLICAR): study protocol for a randomized controlled trial
Andrew B Scholey, David A Camfield, Matthew E Hughes, Will Woods, Con K K Stough, David J White, Shakuntla V Gondalia, Pernille D Frederiksen
A feasibility study examining the effect on lung cancer diagnosis of offering a chest X-ray to higher-risk patients with chest symptoms: protocol for a randomized controlled trial
Christopher N Hurt, Kirsty Roberts, Trevor K Rogers, Gareth O Griffiths, Kerry Hood, Hayley Prout, Annmarie Nelson, Jim Fitzgibbon, Allan Barham, Emma Thomas-Jones, Rhiannon Tudor Edwards, Seow Tien Yeo, William Hamilton, Angela Tod, Richard D Neal
Adjuvant therapy with minocycline for schizophrenia (The MINOS Trial): study protocol for a double-blind randomized placebo-controlled trial
Abebaw Fekadu, Miraf Mesfin, Girmay Medhin, Atalay Alem, Solomon Teferra, Tsehaysina Gebre-Eyesus, Teshale Seboxa, Abraham Assefa, Jemal Hussein, Martha T Lemma, Christina Borba, David C Henderson, Charlotte Hanlon, Teshome Shibre
A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan
Rebecca Walwyn, Laura Potts, Paul McCrone, Anthony L Johnson, Julia C DeCesare, Hannah Baber, Kimberley Goldsmith, Michael Sharpe, Trudie Chalder, Peter D White
Tailored educational intervention for primary care to improve the management of dementia: the EVIDEM-ED cluster randomized controlled trial
Jane Wilcock, Steve Iliffe, Mark Griffin, Priya Jain, Ingela Thuné-Boyle, Frances Lefford, David Rapp
Prevention of ICU delirium and delirium-related outcome with haloperidol: a study protocol for a multicenter randomized controlled trial
Mark van den Boogaard, Arjen J Slooter, Roger JM Brüggemann, Lisette Schoonhoven, Michael A Kuiper, Peter HJ van der Voort, Marga E Hoogendoorn, Albert Beishuizen, Jeroen A Schouten, Peter E Spronk, Saskia Houterman, Johannes G van der Hoeven, Peter Pickkers
A community-based intervention for primary prevention of cardiovascular diseases in the slums of Nairobi: the SCALE UP study protocol for a prospective quasi-experimental community-based trial
Samuel O Oti, Steven JM van de Vijver, Catherine Kyobutungi, Gabriela B Gomez, Charles Agyemang, Eric P Moll van Charante, Lizzy M Brewster, Marleen E Hendriks, Constance Schultsz, Remare Ettarh, Alex Ezeh, Joep Lange
Platelet-rich plasma (PRP) in chronic epicondylitis: study protocol for a randomized controlled trial
Jose I Martin, Josu Merino, Leire Atilano, Luis M Areizaga, Maria C Gomez-Fernandez, Natalia Burgos-Alonso, Isabel Andia
Surgical trials and trial registers: a cross-sectional study of randomized controlled trials published in journals requiring trial registration in the author instructions
Julia LS Hardt, Maria-Inti Metzendorf, Joerg J Meerpohl
Effectiveness and cost effectiveness of guided online treatment for patients with major depressive disorder on a waiting list for psychotherapy: study protocol of a randomized controlled trial
Robin Maria Francisca Kenter, Annemieke van Straten, Sabine Heleen Hobbel, Filip Smit, Judith Bosmans, Aartjan Beekman, Pim Cuijpers
Trial-based clinical and economic analyses: the unhelpful quest for conformity
David GT Whitehurst, Stirling Bryan
The effect of Baduanjin exercise for physical and psychological wellbeing of college students: study protocol for a randomized controlled trial
Guohua Zheng, Moyi Li, Xiulu Lan, Xinghui Yan, Qiu Lin, Lidian Chen, Jing Tao, Xin Zheng, Junzhe Li, Bai Chen, Qianying Fang
A prospective, randomized, placebo-controlled, double-blind, multicenter study of the effects of irbesartan on aortic dilatation in Marfan syndrome (AIMS trial): study protocol
Michael J Mullen, Marcus D Flather, Xu Yu Jin, William G Newman, Guliz Erdem, David Gaze, Oswaldo Valencia, Winston Banya, Claire E Foley, Anne Child
PACE-UP (Pedometer and consultation evaluation - UP) – a pedometer-based walking intervention with and without practice nurse support in primary care patients aged 45–75 years: study protocol for a randomised controlled trial
Tess Harris, Sally M Kerry, Christina R Victor, Sunil M Shah, Steve Iliffe, Michael Ussher, Ulf Ekelund, Julia Fox-Rushby, Peter Whincup, Lee David, Debbie Brewin, Judith Ibison, Stephen DeWilde, Elizabeth Limb, Nana Anokye, Cheryl Furness, Emma Howard, Rebecca Dale, Derek G Cook
A community-based group-guided self-help intervention for low mood and stress: study protocol for a randomized controlled trial
Carrie-Anne McClay, Jill Morrison, Alex McConnachie, Christopher Williams
Comparison between three types of stented pericardial aortic valves (Trivalve trial): study protocol for a randomized controlled trial
Kasra Azarnoush, Bruno Pereira, Christian Dualé, Enrica Dorigo, Mehdi Farhat, Andrea Innorta, Nicolas Dauphin, Etienne Geoffroy, Pascal Chabrot, Lionel Camilleri
The feasibility and acceptability of conducting a trial of specialist medical care and the Lightning Process in children with chronic fatigue syndrome: feasibility randomized controlled trial (SMILE study)
Esther Crawley, Nicola Mills, Lucy Beasant, Debbie Johnson, Simon M Collin, Zuzana Deans, Kate White, Alan Montgomery
Working memory training for adult hearing aid users: study protocol for a double-blind randomized active controlled trial
Helen Henshaw, Melanie A Ferguson
Evidence-based new service package vs. routine service package for smoking cessation to prevent high risk patients from cardiovascular diseases (CVD): study protocol for randomized controlled trial
Myo Nyein Aung, Motoyuki Yuasa, Thaworn Lorga, Saiyud Moolphate, Hiroshi Fukuda, Tsutomu Kitajima, Hirohide Yokokawa, Kazuo Minematsu, Susumu Tanimura, Yoshimune Hiratsuka, Koichi Ono, Prissana Naunboonruang, Payom Thinuan, Sachio Kawai, Yaoyanee Suya, Somboon Chumvicharana, Eiji Marui
A tailored implementation intervention to implement recommendations addressing polypharmacy in multimorbid patients: study protocol of a cluster randomized controlled trial
Cornelia Jäger, Tobias Freund, Jost Steinhäuser, Stefanie Joos, Michel Wensing, Joachim Szecsenyi
The correlation between the number of eligible patients in routine clinical practice and the low recruitment level in clinical trials: a retrospective study using electronic medical records
Eriko Sumi, Satoshi Teramukai, Keiichi Yamamoto, Motohiko Satoh, Kenya Yamanaka, Masayuki Yokode
“läuft.” - a school-based multi-component program to establish a physically active lifestyle in adolescence: study protocol for a cluster-randomized controlled trial
Vivien Suchert, Barbara Isensee, Julia Hansen, Maike Johannsen, Claus Krieger, Katrin Müller, Ingeborg Sauer, Burkhard Weisser, James D Sargent, Reiner Hanewinkel
MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial
Chris Smith, Uk Vannak, Ly Sokhey, Thoai D Ngo, Judy Gold, Khemrin Khut, Phil Edwards, Tung Rathavy, Caroline Free
Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England
Matthew Boyd, Justin Waring, Nick Barber, Rajnikant Mehta, Antony Chuter, Anthony J Avery, Nde-Eshimuni Salema, James Davies, Asam Latif, Lukasz Tanajewski, Rachel A Elliott
An intervention to improve mental health care for conflict-affected forced migrants in low-resource primary care settings: a WHO MhGAP-based pilot study in Sri Lanka (COM-GAP study)
Chesmal Siriwardhana, Anushka Adikari, Tine Van Bortel, Paul McCrone, Athula Sumathipala
Guided Application of Ventricular Catheters (GAVCA) - multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail
Andreas Schaumann, Ulrich-Wilhelm Thomale
Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial
Shane M McClinton, Timothy W Flynn, Bryan C Heiderscheit, Thomas G McPoil, Daniel Pinto, Pamela A Duffy, John D Bennett
DISCOVER trial– Distal resection of the pancreas with or without coverage of the pancreatic remnant: study protocol of a randomised controlled trial
Matthias Hassenpflug, Thomas Bruckner, Philip Knebel, Markus K Diener, Markus W Büchler, Jens Werner
Transversus abdominis plane block following abdominally based breast reconstruction: study protocol for a randomized controlled trial
Toni Zhong, Marie Ojha, Shaghayegh Bagher, Kate Butler, Anne C O’Neill, Stuart A McCluskey, Hance Clarke, Stefan OP Hofer, Coimbatore Srinivas
Corticosteroid injection for shoulder pain: single-blind randomized pilot trial in primary care
Tim A Holt, David Mant, Andrew Carr, Stephen Gwilym, David Beard, Christy Toms, Ly-Mee Yu, Jonathan Rees
Efficacy and safety of acupuncture for chronic dizziness: study protocol for a randomized controlled trial
Zhe Xue, Cun-Zhi Liu, Guang-Xia Shi, Yan Liu, Zhao-Xin Li, Zhen-Hua Zhang, Lin-Peng Wang
The use of mindfulness-based cognitive therapy for improving quality of life for inflammatory bowel disease patients: study protocol for a pilot randomised controlled trial with embedded process evaluation
Mariyana Schoultz, Iain M Atherton, Gill Hubbard, Angus JM Watson
Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial
Mark A Buhagiar, Justine M Naylor, Ian A Harris, Wei Xuan, Friedbert Kohler, Rachael J Wright, Renee Fortunato
Physiotherapy to improve physical activity in community-dwelling older adults with mobility problems (Coach2Move): study protocol for a randomized controlled trial
Nienke M de Vries, J Bart Staal, Steven Teerenstra, Eddy MM Adang, Marcel GM Olde Rikkert, Maria WG Nijhuis-van der Sanden
Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients
Pedro Beraldo de Andrade, Luiz Alberto Piva e Mattos, Marden André Tebet, Fábio Salerno Rinaldi, Vinícius Cardozo Esteves, Ederlon Ferreira Nogueira, João Ítalo Dias França, Mônica Vieira Athanazio de Andrade, Robson Alves Barbosa, André Labrunie, Alexandre Antônio Cunha Abizaid, Amanda Guerra de Moraes Rego Sousa
Effect of Korean red ginseng on cold hypersensitivity in the hands and feet: study protocol for a randomized controlled trial
Kyoung-Sun Park, Jin-Woo Kim, Jun-Young Jo, Deok-Sang Hwang, Chang-Hoon Lee, Jun-Bock Jang, Kyung-Sub Lee, Inkwon Yeo, Jin-Moo Lee
Guided and unguided CBT for social anxiety disorder and/or panic disorder via the Internet and a smartphone application: study protocol for a randomised controlled trial
Philip Lindner, Ekaterina Ivanova, Kien Hoa Ly, Gerhard Andersson, Per Carlbring
The efficacy and safety of Baoji Tablets for treating common cold with summer-heat and dampness syndrome: study protocol for a randomized controlled trial
Rui-zhi Feng, Jian-qin Lv, Angela K Johnson, Juan D Montoya, Bing Mao
Intralesional cryotherapy versus excision and corticosteroids or brachytherapy for keloid treatment: study protocol for a randomised controlled trial
Eveline Bijlard, Reinier Timman, Gerda M Verduijn, Frank B Niessen, Johan W van Neck, Jan J V Busschbach, Marc A M Mureau
The effect of IPS-modified, an early intervention for people with mood and anxiety disorders: study protocol for a randomised clinical superiority trial
Lone Hellström, Per Bech, Merete Nordentoft, Jane Lindschou, Lene Falgaard Eplov
Comparing specialist medical care with specialist medical care plus the Lightning Process® for chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME): study protocol for a randomised controlled trial (SMILE Trial)
Esther Crawley, Nicola Mills, Will Hollingworth, Zuzana Deans, Jonathan A Sterne, Jenny L Donovan, Lucy Beasant, Alan Montgomery
Effectiveness of personalised, home-based nutritional counselling on infant feeding practices, morbidity and nutritional outcomes among infants in Nairobi slums: study protocol for a cluster randomised controlled trial
Elizabeth W Kimani-Murage, Catherine Kyobutungi, Alex C Ezeh, Frederick Wekesah, Milka Wanjohi, Peterrock Muriuki, Rachel N Musoke, Shane A Norris, Paula Griffiths, Nyovani J Madise
Treatment of neonatal jaundice with filtered sunlight in Nigerian neonates: study protocol of a non-inferiority, randomized controlled trial
Tina M Slusher, Bolajoko O Olusanya, Hendrik J Vreman, Ronald J Wong, Ann M Brearley, Yvonne E Vaucher, David K Stevenson
Meeting the challenges of recruitment to multicentre, community-based, lifestyle-change trials: a case study of the BeWEL trial
Shaun Treweek, Erna Wilkie, Angela M Craigie, Stephen Caswell, Joyce Thompson, Robert JC Steele, Martine Stead, Annie S Anderson
Supporting the improvement and management of prescribing for urinary tract infections (SIMPle): protocol for a cluster randomized trial
Sinead Duane, Aoife Callan, Sandra Galvin, Andrew W Murphy, Christine Domegan, Eamon O’Shea, Martin Cormican, Kathleen Bennett, Martin O’Donnell, Akke Vellinga
Effectiveness of a tailored intervention to improve cardiovascular risk management in primary care: study protocol for a randomised controlled trial
Elke Huntink, Naomi Heijmans, Michel Wensing, Jan van Lieshout
Computed tomographic coronary angiography for patients with heart failure (CTA-HF): a randomized controlled trial (IMAGE HF Project 1-C)
Benjamin JW Chow, Rachel E Green, Doug Coyle, Mika Laine, Helena Hanninen, Hanna Leskinen, Miroslav Rajda, Eric Larose, Juha Hartikainen, Marja Hedman, Lisa Mielniczuk, Eileen O’Meara, Robert A deKemp, Ran Klein, Ian Paterson, James A White, Seppo Yla-Herttuala, Alex Leber, Vikas Tandon, Ting Lee, Abdul Al-Hesayen, Renee Hessian, Taylor Dowsley, Malek Kass, Cathy Kelly, Linda Garrard, Jean-Claude Tardif, Juhani Knuuti, Rob S Beanlands, George A Wells
Cognitive-behavioral therapy vs. light therapy for preventing winter depression recurrence: study protocol for a randomized controlled trial
Kelly J Rohan, Maggie Evans, Jennifer N Mahon, Lilya Sitnikov, Sheau-Yan Ho, Yael I Nillni, Teodor T Postolache, Pamela M Vacek
Acupuncture as prophylaxis for menstrual-related migraine: study protocol for a multicenter randomized controlled trial
Xiao-Zhe Zhang, Lei Zhang, Jia Guo, Lin Zeng, Yi Yang, Tao Zhang, Guang-Xia Shi, Hui-Lin Liu, Lin-Peng Wang
Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial
Simone Oliveira Sierra, Alessandro Melo Deana, Raquel Agnelli Mesquita Ferrari, Priscilla Maia Albarello, Sandra Kalil Bussadori, Kristianne Porta Santos Fernandes
“Spin” in wound care research: the reporting and interpretation of randomized controlled trials with statistically non-significant primary outcome results or unspecified primary outcomes
Suzanne Lockyer, Rob Hodgson, Jo C Dumville, Nicky Cullum
Oral versus intravenous antibiotics for patients with Klebsiella pneumoniae liver abscess: study protocol for a randomized controlled trial
James Molton, Rachel Phillips, Mihir Gandhi, Joanne Yoong, David Lye, Thuan Tong Tan, Dale Fisher, Sophia Archuleta
Rationale and study design of ViPS – variable pressure support for weaning from mechanical ventilation: study protocol for an international multicenter randomized controlled open trial
Thomas Kiss, Andreas Güldner, Thomas Bluth, Christopher Uhlig, Peter Markus Spieth, Klaus Markstaller, Roman Ullrich, Samir Jaber, Jose Alberto Santos, Jordi Mancebo, Luigi Camporota, Richard Beale, Guilherme Schettino, Felipe Saddy, Immaculada Vallverdú, Bärbel Wiedemann, Thea Koch, Marcus Josephus Schultz, Paolo Pelosi, Marcelo Gama de Abreu
Electroacupuncture at Jing-jiaji points for neck pain caused by cervical spondylosis: a study protocol for a randomized controlled pilot trial
Zhong-ren Sun, Jin-huan Yue, Qin-hong Zhang
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 Hofer, Brett Beber, John Semple, Mitchell Brown, Sheina Macadam, Peter Lennox, Tony Panzarella, Colleen McCarthy, Nancy Baxter
Acupuncture for dry eye syndrome after refractive surgery: study protocol for a randomized controlled trial
Hyesun Jang, Sanghun Lee, Tae-Hun Kim, Ae-Ran Kim, Minhee Lee, Jun-Hwan Lee
Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment: the DIFFICAIR trial – trial protocol for a cluster randomized clinical trial
Anders Kehlet Nørskov, Charlotte Valentin Rosenstock, Jørn Wetterslev, Lars Hyldborg Lundstrøm
Development and feasibility testing of decision support for patients who are candidates for a prophylactic implantable defibrillator: a study protocol for a pilot randomized controlled trial
Sandra L Carroll, Michael McGillion, Dawn Stacey, Jeff S Healey, Gina Browne, Heather M Arthur, Lehana Thabane
Randomised controlled trial of a brief alcohol intervention in a general hospital setting
Celia J Shiles, Una P Canning, Sandra A Kennell-Webb, Caroline M Gunstone, E Jane Marshall, Timothy J Peters, Simon C Wessely
Cognitive-reminiscence therapy and usual care for depression in young adults: study protocol for a randomized controlled trial
David J Hallford, David Mellor
The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial
Emmanuel Futier, Catherine Paugam-Burtz, Jean-Michel Constantin, Bruno Pereira, Samir Jaber
Efficacy of repetitive transcranial magnetic stimulation in the prevention of relapse of depression: study protocol for a randomized controlled trial
Huaning Wang, Yunyun Xue, Yunchun Chen, Ruiguo Zhang, Huaihai Wang, Yahong Zhang, Jingli Gan, Liyi Zhang, Qingrong Tan
Routine versus selective cardiac magnetic resonance in non-ischemic heart failure – OUTSMART-HF: study protocol for a randomized controlled trial (IMAGE-HF (heart failure) project 1-B)
Ian Paterson, George A Wells, Justin A Ezekowitz, James A White, Matthias G Friedrich, Lisa M Mielniczuk, Eileen O’Meara, Benjamin Chow, Rob A deKemp, Ran Klein, Carole Dennie, Alexander Dick, Doug Coyle, Girish Dwivedi, Miroslaw Rajda, Graham A Wright, Mika Laine, Helena Hanninen, Eric Larose, Kim A Connelly, Howard Leong-Poi, Andrew G Howarth, Ross A Davies, Lloyd Duchesne, Seppo Yla-Herttuala, Antti Saraste, Paul Farand, Linda Garrard, Jean-Claude Tardif, Malcolm Arnold, Juhani Knuuti, Rob Beanlands, Kwan L Chan
Evaluation of ergonomic and education interventions to reduce occupational sitting in office-based university workers: study protocol for a randomized controlled trial
Antonia Radas, Martin Mackey, Andrew Leaver, Anna-Louise Bouvier, Josephine Y Chau, Debra Shirley, Adrian Bauman
Study on psychoeducation enhancing results of adherence in patients with schizophrenia (SPERA-S): study protocol for a randomized controlled trial
Donatella Rita Petretto, Antonio Preti, Carlo Zuddas, Franco Veltro, Marco Bruno Luigi Rocchi, Davide Sisti, Valentina Martinelli, Mauro Giovanni Carta, Carmelo Masala
Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial
Lieve M Roets-Merken, Maud JL Graff, Sytse U Zuidema, Pieter GJM Hermsen, Steven Teerenstra, Gertrudis IJM Kempen, Myrra JFJ Vernooij-Dassen
Intermittent preventive treatment: efficacy and safety of sulfadoxine-pyrimethamine and sulfadoxine-pyrimethamine plus piperaquine regimens in schoolchildren of the Democratic Republic of Congo: a study protocol for a randomized controlled trial
Joachim Yorokpa Doua, Junior Matangila, Pascal Lutumba, Jean-Pierre Van geertruyden
Preventing and lessening exacerbations of asthma in school-age children associated with a new term (PLEASANT): study protocol for a cluster randomised control trial
Michelle J Horspool, Steven A Julious, Jonathan Boote, Mike J Bradburn, Cindy L Cooper, Sarah Davis, Heather Elphick, Paul Norman, W Henry Smithson, Tjeerd vanStaa