Ausgabe 1/2015
Inhalt (599 Artikel)
Selective or stepwise removal of deep caries in deciduous molars: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Falk Schwendicke, Hardy Schweigel, Marina Agathi Petrou, Ruth Santamaria, Werner Hopfenmüller, Christian Finke, Sebastian Paris
Specifying the target difference in the primary outcome for a randomised controlled trial: guidance for researchers
- Open Access
- Research
Jonathan A Cook, Jenni Hislop, Douglas G Altman, Peter Fayers, Andrew H Briggs, Craig R Ramsay, John D Norrie, Ian M Harvey, Brian Buckley, Dean Fergusson, Ian Ford, Luke D Vale
Evaluating the effects of increasing physical activity to optimize rehabilitation outcomes in hospitalized older adults (MOVE Trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Catherine M Said, Meg E Morris, Jennifer L McGinley, Cassandra Szoeke, Barbara Workman, Danny Liew, Keith Hill, Michael Woodward, Joanne E Wittwer, Leonid Churilov, Cameron Ventura, Julie Bernhardt
Effects of adaptive servo-ventilation therapy on cardiac function and remodeling in patients with chronic heart failure (SAVIOR-C): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Yoshihiko Seino, Shin-ichi Momomura, Yasuki Kihara, Hitoshi Adachi, Yoshio Yasumura, Hiroyuki Yokoyama
Improving the pre-screening of eligible patients in order to increase enrollment in cancer clinical trials
- Open Access
- Research
Boris Campillo-Gimenez, Camille Buscail, Oussama Zekri, Brigitte Laguerre, Elisabeth Le Prisé, Renaud De Crevoisier, Marc Cuggia
The natural history of conducting and reporting clinical trials: interviews with trialists
- Open Access
- Research
Rebecca MD Smyth, Ann Jacoby, Douglas G Altman, Carrol Gamble, Paula R Williamson
A primary care, electronic health record-based strategy to promote safe drug use: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Kamila Przytula, Stacy Cooper Bailey, William L Galanter, Bruce L Lambert, Neeha Shrestha, Carolyn Dickens, Suzanne Falck, Michael S Wolf
Clinical and cost effectiveness of computer treatment for aphasia post stroke (Big CACTUS): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Rebecca Palmer, Cindy Cooper, Pam Enderby, Marian Brady, Steven Julious, Audrey Bowen, Nicholas Latimer
Application time for postoperative wound dressing following breast augmentation with implants: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Denise de Almeida Mendes, Daniela Francescato Veiga, Joel Veiga-Filho, Fernando Elias Martins Fonseca, Luiz Francisley de Paiva, Neil Ferreira Novo, Ana Beatriz Alkmin Teixeira Loyola, Lydia Masako Ferreira
The effects of stimulation of the autonomic nervous system via perioperative nutrition on postoperative ileus and anastomotic leakage following colorectal surgery (SANICS II trial): a study protocol for a double-blind randomized controlled trial
- Open Access
- Study protocol
Emmeline G Peters, Boudewijn JJ Smeets, Marloes Dekkers, Marc D Buise, Wouter J de Jonge, Gerrit D Slooter, Tammo S de Vries Reilingh, Johannes A Wegdam, Grard AP Nieuwenhuijzen, Harm JT Rutten, Ignace HJT de Hingh, Mickael Hiligsmann, Wim A Buurman, Misha DP Luyer
“High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial” (HIGHLOW trial)
- Open Access
- Study protocol
Giulio Mari, Dario Maggioni, Andrea Costanzi, Angelo Miranda, Luca Rigamonti, Jacopo Crippa, Carmelo Magistro, Stefano Di Lernia, Antonello Forgione, Pietro Carnevali, Michele Nichelatti, Pierluigi Carzaniga, Francesco Valenti, Marco Rovagnati, Mattia Berselli, Eugenio Cocozza, Lorenzo Livraghi, Matteo Origi, Ildo Scandroglio, Francesco Roscio, Antonio De Luca, Giovanni Ferrari, Raffaele Pugliese
Ghana’s Ensure Mothers and Babies Regular Access to Care (EMBRACE) program: study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Kimiyo Kikuchi, Evelyn Ansah, Sumiyo Okawa, Akira Shibanuma, Margaret Gyapong, Seth Owusu-Agyei, Abraham Oduro, Gloria Quansah-Asare, Abraham Hodgson, Masamine Jimba
The efficacy of motivational counseling and SMS-reminders on daily sitting time in patients with rheumatoid arthritis: protocol for a randomized controlled trial
- Open Access
- Study protocol
Bente Appel Esbensen, Tanja Thomsen, Merete L Hetland, Nina Beyer, Julie Midtgaard, Katrine Løppenthin, Poul Jennum, Mikkel Østergaard, Jan Sørensen, Robin Christensen, Mette Aadahl
Meropenem versus piperacillin-tazobactam for definitive treatment of bloodstream infections due to ceftriaxone non-susceptible Escherichia coli and Klebsiella spp (the MERINO trial): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Patrick NA Harris, Anton Y Peleg, Jon Iredell, Paul R Ingram, Spiros Miyakis, Andrew J Stewardson, Benjamin A Rogers, Emma S McBryde, Jason A Roberts, Jeff Lipman, Eugene Athan, Sanjoy K Paul, Peter Baker, Tiffany Harris-Brown, David L Paterson
The FOCUS trial: cognitive remediation plus standard treatment versus standard treatment for patients at ultra-high risk for psychosis: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Louise B Glenthøj, Birgitte Fagerlund, Lasse Randers, Carsten R Hjorthøj, Christina Wenneberg, Kristine Krakauer, Astrid Vosgerau, Christian Gluud, Alice Medalia, David L Roberts, Merete Nordentoft
A phase II trial for the efficacy of physiotherapy intervention for early-onset hip osteoarthritis: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Joanne L Kemp, Kate Moore, Marlene Fransen, Trevor G Russell, Kay M Crossley
Progressive high-load strength training compared with general low-load exercises in patients with rotator cuff tendinopathy: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Kim G Ingwersen, Robin Christensen, Lilli Sørensen, Hans RI Jørgensen, Steen Lund Jensen, Sten Rasmussen, Karen Søgaard, Birgit Juul-Kristensen
Empirical evidence for outcome reporting bias in randomized clinical trials of acupuncture: comparison of registered records and subsequent publications
- Open Access
- Research
Chun-Xiang Su, Mei Han, Jun Ren, Wen-Yuan Li, Shu-Jin Yue, Yu-Fang Hao, Jian-Ping Liu
Pilot study to evaluate a tailored text message intervention for pregnant smokers (MiQuit): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Sue Cooper, Katharine Foster, Felix Naughton, Jo Leonardi-Bee, Stephen Sutton, Michael Ussher, Matthew Leighton, Alan Montgomery, Steve Parrott, Tim Coleman
Lignocaine/phenylephrine nasal spray vs. placebo for the pain and distress of nasogastric tube insertion in children: a study protocol for a randomized controlled trial
- Open Access
- Study protocol
Simon S Craig, Robert W Seith, John A Cheek, Adam West, Kathryn Wilson, Diana Egerton-Warburton
Effectiveness of three oral hygiene regimens on oral malodor reduction: a randomized clinical trial
- Open Access
- Research
Ei Ei Aung, Masayuki Ueno, Takashi Zaitsu, Sayaka Furukawa, Yoko Kawaguchi
Center for stroke disparities solutions community- based care transition interventions: study protocol of a randomized controlled trial
- Open Access
- Study protocol
Penny H Feldman, Margaret V McDonald, Melissa A Trachtenberg, Antoinette Schoenthaler, Noreen Coyne, Jeanne Teresi
Couplelinks - an online intervention for young women with breast cancer and their male partners: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Karen Fergus, Saunia Ahmad, Deborah L McLeod, Joanne Stephen, Sandra Gardner, Amanda Pereira, Ellen Warner, Wendy Carter
A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Chenchen Wang, Timothy McAlindon, Roger A Fielding, William F Harvey, Jeffrey B Driban, Lori Lyn Price, Robert Kalish, Anna Schmid, Tammy M Scott, Christopher H Schmid
Use of moxibustion to treat primary dysmenorrhea at two interventional times: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jie Yang, Siyi Yu, Lixing Lao, Mingxiao Yang, JianPing Chen, Xiao Luo, Yongxia Wang, Xiangzhu Chen, Juan Li, Lihua Zhu, Qianhua Zheng, Youping Hu, Xi Wu, Fanrong Liang
A mindfulness-based stress management program and treatment with omega-3 fatty acids to maintain a healthy mental state in hospital nurses (Happy Nurse Project): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Norio Watanabe, Toshi A Furukawa, Masaru Horikoshi, Fujika Katsuki, Tomomi Narisawa, Mie Kumachi, Yuki Oe, Issei Shinmei, Hiroko Noguchi, Kei Hamazaki, Yutaka Matsuoka
Effects and cost-effectiveness of pharmacogenetic screening for CYP2D6 among older adults starting therapy with nortriptyline or venlafaxine: study protocol for a pragmatic randomized controlled trial (CYSCEtrial)
- Open Access
- Study protocol
Elizabeth JJ Berm, Eelko Hak, Maarten Postma, Marjolein Boshuisen, Laura Breuning, Jacobus RBJ Brouwers, Ton Dhondt, Paul AF Jansen, Rob M Kok, Jan G Maring, Rob van Marum, Hans Mulder, Richard C Oude Voshaar, Arne J Risselada, Harry Venema, Liesbeth Vleugel, Bob Wilffert
Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial
- Open Access
- Update
Kirstine Laerum Sibilitz, Selina Kikkenborg Berg, Tina Birgitte Hansen, Signe Stelling Risom, Trine Bernholdt Rasmussen, Christian Hassager, Lars Køber, Christian Gluud, Lau Caspar Thygesen, Jane Lindschou, Jean Paul Schmid, Rod S Taylor, Ann-Dorthe Zwisler
Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Alistair Nichol, Craig French, Lorraine Little, Jeffrey Presneill, D James Cooper, Samir Haddad, Jacques Duranteau, Olivier Huet, Markus Skrifvars, Yaseen Arabi, Rinaldo Bellomo
A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Sophie Merle Kuhlmann, Arne Bürger, Günter Esser, Florian Hammerle
The Community In-Reach and Care Transition (CIRACT) clinical and cost-effectiveness study: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Alison Watson, Lisa Charlesworth, Ruth Jacob, Denise Kendrick, Philippa Logan, Fiona Marshall, Alan Montgomery, Tracey Sach, Wei Tan, Maria Walker, Justin Waring, Diane Whitham, Opinder Sahota
Immediate access arteriovenous grafts versus tunnelled central venous catheters: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Emma Aitken, Colin Geddes, Pete Thomson, Ram Kasthuri, Mohan Chandramohan, Colin Berry, David Kingsmore
Three donor site dressings in pediatric split-thickness skin grafts: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Craig A McBride, Roy M Kimble, Kellie Stockton
Effect of a diuretic adjustment algorithm and nonpharmacologic management in patients with heart failure: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Maria Karolina Echer Ferreira Feijó, Andreia Biolo, Karen Brasil Ruschel, Letícia Orlandin, Graziella Badin Aliti, Eneida Rejane Rabelo-Silva
The efficacy of electroacupuncture for the treatment of simple female stress urinary incontinence - comparison with pelvic floor muscle training: study protocol for a multicenter randomized controlled trial
- Open Access
- Study protocol
Tongsheng Su, Jing Zhou, Zhishun Liu, Yuelai Chen, Wei Zhang, Haoran Chu, Qiong Luo, Jin Lu, Junming An, Baoyan Liu
Lactose-free milk for infants with acute gastroenteritis in a developing country: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Mona Nabulsi, Nadine Yazbeck, Fatme Charafeddine
Core outcome sets for use in effectiveness trials involving people with bipolar and schizophrenia in a community-based setting (PARTNERS2): study protocol for the development of two core outcome sets
- Open Access
- Study protocol
Thomas Keeley, Humera Khan, Vanessa Pinfold, Paula Williamson, Jonathan Mathers, Linda Davies, Ruth Sayers, Elizabeth England, Siobhan Reilly, Richard Byng, Linda Gask, Mike Clark, Peter Huxley, Peter Lewis, Maximillian Birchwood, Melanie Calvert
The efficacy of indwelling pleural catheter placement versus placement plus talc sclerosant in patients with malignant pleural effusions managed exclusively as outpatients (IPC-PLUS): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Rahul Bhatnagar, Brennan C Kahan, Anna J Morley, Emma K Keenan, Robert F Miller, Najib M Rahman, Nick A Maskell
Effectiveness and cost-effectiveness of cognitive adaptation training as a nursing intervention in long-term residential patients with severe mental illness: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Annemarie PM Stiekema, Piotr J Quee, Marian Dethmers, Edwin R van den Heuvel, Jeroen E Redmeijer, Kees Rietberg, A Dennis Stant, Marte Swart, Jaap van Weeghel, André Aleman, Dawn I Velligan, Robert A Schoevers, Richard Bruggeman, Lisette van der Meer
Improving Decision making On Location of Care with the frail Elderly and their caregivers (the DOLCE study): study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
France Légaré, Nathalie Brière, Dawn Stacey, Henriette Bourassa, Sophie Desroches, Serge Dumont, Kimberly Fraser, Adriana Freitas, Louis‐Paul Rivest, Lise Roy
A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial
- Open Access
- Study protocol
Nadja Klafke, Cornelia Mahler, Cornelia von Hagens, Justine Rochon, Andreas Schneeweiss, Andreas Müller, Hans-Joachim Salize, Stefanie Joos
Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial
- Open Access
- Study protocol
René H Fortelny, Petra Baumann, Wolfgang E Thasler, Markus Albertsmeier, Stefan Riedl, Wolfgang Steurer, Jan Ludolf Kewer, Andreas Shamiyeh
Making research articles fit for purpose: structured reporting of key methods and findings
- Open Access
- Editorial
Douglas G Altman
Transfusion Indication Threshold Reduction (TITRe2) randomized controlled trial in cardiac surgery: statistical analysis plan
- Open Access
- Update
Katie Pike, Rachel L Nash, Gavin J Murphy, Barnaby C Reeves, Chris A Rogers
Thanks to all those who reviewed for Trials in 2014
- Open Access
- Reviewer acknowledgement
Douglas G Altman, Curt D Furberg, Jeremy M Grimshaw
The acute effect of beta-guanidinopropionic acid versus creatine or placebo in healthy men (ABC Trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Fares A Karamat, Deborah L Horjus, Yentl C Haan, Lisa van der Woude, Inge Oudman, Gert A van Montfrans, Joseph F Clark, Lizzy M Brewster
Is the relationship among outcome variables shown in randomized trials?
- Open Access
- Research
David L Schriger, Richelle J Cooper, Ana Lopez-O’Sullivan, Carter Wystrach, Douglas G Altman
RandomizEd controlled trial for pre-operAtive dose-escaLation BOOST in locally advanced rectal cancer (RECTAL BOOST study): study protocol for a randomized controlled trial
- Open Access
- Study protocol
JP Maarten Burbach, Helena M Verkooijen, Martijn Intven, Jean-Paul JE Kleijnen, Mirjam E Bosman, Bas W Raaymakers, Wilhelmina MU van Grevenstein, Miriam Koopman, Enrica Seravalli, Bram van Asselen, Onne Reerink
‘Fit Moms/Mamás Activas’ internet-based weight control program with group support to reduce postpartum weight retention in low-income women: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Suzanne Phelan, Anna Brannen, Karen Erickson, Molly Diamond, Andrew Schaffner, Karen Muñoz-Christian, Ana Stewart, Teresa Sanchez, Vanessa C Rodriguez, Dalila I Ramos, Linda McClure, Caro Stinson, Deborah F Tate
Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial
- Open Access
- Study protocol
Regina Kuhmmer, Karine Margarites Lima, Rodrigo Antonini Ribeiro, Luciano Serpa Hammes, Gisele Alsina Nader Bastos, Maria Claudia Schardosim Cotta de Souza, Carisi Anne Polanczyk, Guilherme Alcides Flores Soares Rollin, Suhelen Caon, Cátia Moreira Guterres, Leni Everson Araújo Leite, Tássia Scholante Delabary, Maicon Falavigna
Home-based tele-supervising rehabilitation for brain infarction patients (HTRBIP): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Wei Jin, Jing Chen, Fangfang Shi, Wuqing Yang, Yu Zhang, Yuan Liu, Wenshuai Dong, Yan Jin, Wenfeng Ma, Zhongju Ma, Xinli Min, Yin Jin, Yong Gu, Chuancheng Ren
Reducing suicidal thoughts in the Australian general population through web-based self-help: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Bregje AJ van Spijker, Alison L Calear, Philip J Batterham, Andrew J Mackinnon, John A Gosling, Ad JFM Kerkhof, Daniela Solomon, Helen Christensen
Combining cognitive bias modification training with motivational support in alcohol dependent outpatients: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Marilisa Boffo, Thomas Pronk, Reinout W Wiers, Stefania Mannarini
Population pharmacokinetic modeling of the Qishe pill in three major traditional Chinese medicine-defined constitutional types of healthy Chinese subjects: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Yue-li Sun, Ting Hou, Shu-fen Liu, Zhong-liang Zhang, Ning Zhang, Min Yao, Long Yang, Qi Shi, Xue-jun Cui, Yong-jun Wang
Assessing the effectiveness of a pharmacist-delivered smoking cessation program in the State of Qatar: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Maguy Saffouh El Hajj, Nadir Kheir, Ahmad Mohd Al Mulla, Daoud Al-Badriyeh, Ahmad Al Kaddour, Ziyad R Mahfoud, Mohammad Salehi, Nadia Fanous
WARRIOR-trial - is routine radiography following the 2-week initial follow-up in trauma patients with wrist and ankle fractures necessary: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Nikki L Weil, M Frank Termaat, Sidney M Rubinstein, Mostafa El Moumni, Wietse P Zuidema, Robert Jan Derksen, Pieta Krijnen, Leti van Bodegom-Vos, Klaus W Wendt, Cornelis van Kuijk, Frits R Rosendaal, Roelf S Breederveld, J Carel Goslings, Inger B Schipper, Maurits W van Tulder
The PREEMPT study - evaluating smartphone-assisted n-of-1 trials in patients with chronic pain: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Colin Barr, Maria Marois, Ida Sim, Christopher H Schmid, Barth Wilsey, Deborah Ward, Naihua Duan, Ron D Hays, Joshua Selsky, Joseph Servadio, Marc Schwartz, Clyde Dsouza, Navjot Dhammi, Zachary Holt, Victor Baquero, Scott MacDonald, Anthony Jerant, Ron Sprinkle, Richard L Kravitz
The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Seung-Yeon Cho, Dong-Hyuk Lee, Hee Sup Shin, Seung Hwan Lee, Jun Seok Koh, Woo-Sang Jung, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko, Ho Kim, Seong-Uk Park
Effect of a multifaceted educational program for care staff concerning fecal incontinence in nursing home patients: study protocol of a cluster randomized controlled trial
- Open Access
- Study protocol
Lene Elisabeth Blekken, Anne Guttormsen Vinsnes, Kari Hanne Gjeilo, Siv Mørkved, Øyvind Salvesen, Christine Norton, Sigrid Nakrem
The gametocytocidal efficacy of primaquine in malaria asymptomatic carriers treated with dihydroartemisinin-piperaquine in The Gambia (PRINOGAM): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Joseph Okebe, Teun Bousema, Muna Affara, GianLuca DiTanna, Alice C Eziefula, Musa Jawara, Davis Nwakanma, Alfred Amambua-Ngwa, Jean-Pierre Van geertruyden, Chris Drakeley, Umberto D’Alessandro
The benefit of minocycline on negative symptoms in early-phase psychosis in addition to standard care - extent and mechanism (BeneMin): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Danuta M Lisiecka, John Suckling, Thomas RE Barnes, Imran B Chaudhry, Paola Dazzan, Nusrat Husain, Peter B Jones, Eileen M Joyce, Stephen M Lawrie, Rachel Upthegrove, Bill Deakin
The Stroke Hyperglycemia Insulin Network Effort (SHINE) trial: an adaptive trial design case study
- Open Access
- Research
Jason T Connor, Kristine R Broglio, Valerie Durkalski, William J Meurer, Karen C Johnston
Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet study): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Åsmund Avdem Fretland, Airazat M Kazaryan, Bjørn Atle Bjørnbeth, Kjersti Flatmark, Marit Helen Andersen, Tor Inge Tønnessen, Gudrun Maria Waaler Bjørnelv, Morten Wang Fagerland, Ronny Kristiansen, Karl Øyri, Bjørn Edwin
Safety and feasibility of xenon as an adjuvant to sevoflurane anaesthesia in children undergoing interventional or diagnostic cardiac catheterization: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Sarah Devroe, Jurgen Lemiere, Marc Van de Velde, Marc Gewillig, Derize Boshoff, Steffen Rex
Recruiting to inpatient-based rehabilitation trials: lessons learned
- Open Access
- Commentary
Sarah F Tyson, Nessa Thomas, Andy Vail, Pippa Tyrrell
A core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey
- Open Access
- Study protocol
Steven MacLennan, Hendrika J Bekema, Paula R Williamson, Marion K Campbell, Fiona Stewart, Sara J MacLennan, James MO N’Dow, Thomas BL Lam
Pain reduction with oral methotrexate in knee osteoarthritis, a pragmatic phase iii trial of treatment effectiveness (PROMOTE): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Sarah R Kingsbury, Puvan Tharmanathan, Nigel K Arden, Michael Batley, Fraser Birrell, Kim Cocks, Michael Doherty, Chris J Edwards, Toby Garrood, Andrew J Grainger, Michael Green, Catherine Hewitt, Rod Hughes, Robert Moots, Terence W O’Neill, Edward Roddy, David L Scott, Fiona E Watt, David J Torgerson, Philip G Conaghan
Can oral corticosteroids reduce the severity or duration of an acute cough, and the associated National Health Service and societal costs, in adults presenting to primary care? Study protocol for a randomised controlled trial
- Open Access
- Study protocol
Harriet E Downing, Fran Carroll, Sara T Brookes, Sandra Hollinghurst, David Timmins, Elizabeth Orton, Kay Wang, Denise Kendrick, Paul Little, Mike V Moore, Anthony Harnden, Matthew Thompson, Margaret T May, Alastair D Hay
Recruitment and retention strategies and the examination of attrition bias in a randomised controlled trial in children’s centres serving families in disadvantaged areas of England
- Open Access
- Methodology
Paul Hindmarch, Adrian Hawkins, Elaine McColl, Mike Hayes, Gosia Majsak-Newman, Joanne Ablewhite, Toity Deave, Denise Kendrick
Does offering an incentive payment improve recruitment to clinical trials and increase the proportion of socially deprived and elderly participants?
- Open Access
- Research
Claudine G Jennings, Thomas M MacDonald, Li Wei, Morris J Brown, Lewis McConnachie, Isla S Mackenzie
Clinical trial to evaluate the performance of a flexible self-adherent absorbent dressing coated with a soft silicone layer compared to a standard wound dressing after orthopedic or spinal surgery: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jan Bredow, Johannes Oppermann, Katharina Hoffmann, Martin Hellmich, Birte Wenk, Marvin Simons, Peer Eysel, Kourosh Zarghooni
Aspiration sclerotherapy combined with pasireotide to improve reduction of large symptomatic hepatic cysts (SCLEROCYST): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Titus FM Wijnands, Tom JG Gevers, Leo J Schultze Kool, Joost PH Drenth
The INCA trial (Impact of NOD2 genotype-guided antibiotic prevention on survival in patients with liver Cirrhosis and Ascites): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Markus Casper, Martin Mengel, Christine Fuhrmann, Eva Herrmann, Beate Appenrodt, Peter Schiedermaier, Matthias Reichert, Tony Bruns, Cornelius Engelmann, Frank Grünhage, Frank Lammert
Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Francesco Cerritelli, Luca Cicchitti, Marta Martelli, Gina Barlafante, Cinzia Renzetti, Gianfranco Pizzolorusso, Mariacristina Lupacchini, Marianna D’Orazio, Benedetta Marinelli, Vincenzo Cozzolino, Paola Fusilli, Carmine D’Incecco
Comparing different dosing regimens of bevacizumab in the treatment of neovascular macular degeneration: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Alexander JE Foss, Margaret Childs, Barnaby C Reeves, Theo Empeslidis, Paul Tesha, Sushma Dhar-Munshi, Samah Mughal, Lucy Culliford, Chris A Rogers, Wei Tan, Alan Montgomery
Effective recruitment of participants to a phase I study using the internet and publicity releases through charities and patient organisations: analysis of the adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D)
- Open Access
- Research
James Heywood, Marina Evangelou, Donna Goymer, Jane Kennet, Katerina Anselmiova, Catherine Guy, Criona O’Brien, Sarah Nutland, Judy Brown, Neil M Walker, John A Todd, Frank Waldron-Lynch
Short-stretch inelastic compression bandage in knee swelling following total knee arthroplasty study (STICKS): study protocol for a randomised controlled feasibility study
- Open Access
- Study protocol
Timothy M Brock, Andrew P Sprowson, Scott Muller, Mike R Reed
A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - quanti-qualitative appointment timing
- Open Access
- Research
Sangeetha Paramasivan, Sean Strong, Caroline Wilson, Bruce Campbell, Jane M Blazeby, Jenny L Donovan
Erratum to: Acupuncture for menopausal vasomotor symptoms: study protocol for a randomised controlled trial
- Open Access
- Erratum
Marie Pirotta, Carolyn Ee, Helena Teede, Patty Chondros, Simon French, Stephen Myers, Charlie Xue
The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Ricardo Fontes-Carvalho, Francisco Sampaio, Madalena Teixeira, Vasco Gama, Adelino F Leite-Moreira
Physical ACtivity facilitation for Elders (PACE): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Gemma S Morgan, Anne M Haase, Rona Campbell, Yoav Ben-Shlomo
Pit excision with phenolisation of the sinus tract versus radical excision in sacrococcygeal pilonidal sinus disease: study protocol for a single centre randomized controlled trial
- Open Access
- Study protocol
Edgar JB Furnée, Paul HP Davids, Apollo Pronk, Niels Smakman
Erratum to: Disappointment and adherence among parents of newborns allocated to the control group: a qualitative study of a randomized clinical trial
- Open Access
- Erratum
Sandra Meinich Petersen, Vibeke Zoffmann, Jesper Kjærgaard, Lone Graff Stensballe, Gorm Greisen
Vitamin C as an adjuvant for treating major depressive disorder and suicidal behavior, a randomized placebo-controlled clinical trial
- Open Access
- Research
Ali Sahraian, Ahmad Ghanizadeh, Fereshteh Kazemeini
Sustained Aeration of Infant Lungs (SAIL) trial: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Elizabeth E Foglia, Louise S Owen, Marta Thio, Sarah J Ratcliffe, Gianluca Lista, Arjan te Pas, Helmut Hummler, Vinay Nadkarni, Anne Ades, Michael Posencheg, Martin Keszler, Peter Davis, Haresh Kirpalani
Persistent Occiput Posterior position - OUTcomes following manual rotation (POP-OUT): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Hala Phipps, Jon A Hyett, Sabrina Kuah, John Pardey, Joanne Ludlow, Andrew Bisits, Felicity Park, David Kowalski, Bradley de Vries
Comparative effectiveness of home blood pressure telemonitoring (HBPTM) plus nurse case management versus HBPTM alone among Black and Hispanic stroke survivors: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Tanya M Spruill, Olajide Williams, Jeanne A Teresi, Susan Lehrer, Liliana Pezzin, Salina P Waddy, Ronald M Lazar, Stephen K Williams, Girardin Jean-Louis, Joseph Ravenell, Sunil Penesetti, Albert Favate, Judith Flores, Katherine A Henry, Anne Kleiman, Steven R Levine, Richard Sinert, Teresa Y Smith, Michelle Stern, Helen Valsamis, Gbenga Ogedegbe
Enhancing inpatient psychotherapeutic treatment with online self-help: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Rüdiger Zwerenz, Jan Becker, Rudolf J Knickenberg, Karin Hagen, Michael Dreier, Klaus Wölfling, Manfred E Beutel
Preference-adaptive randomization in comparative effectiveness studies
- Open Access
- Methodology
Benjamin French, Dylan S Small, Julie Novak, Kathryn A Saulsgiver, Michael O Harhay, David A Asch, Kevin G Volpp, Scott D Halpern
Evaluation of the immediate effect of acupuncture on pain, cervical range of motion and electromyographic activity of the upper trapezius muscle in patients with nonspecific neck pain: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Simone Aparecida Penimpedo Calamita, Daniela Aparecida Biasotto-Gonzalez, Nivea Cristina De Melo, Douglas Meira dos Santos, Roberta de Lassa, Fabiana Sarilho de Mendonça, Claudia Santos Oliveira, César Ferreira Amorim, Tabajara Oliveira Gonzalez, Marco Antônio Fumagalli, Cid André Fidelis Paula de Gomes, Fabiano Politti
Transcutaneous electrical stimulation at auricular acupoints innervated by auricular branch of vagus nerve pairing tone for tinnitus: study protocol for a randomized controlled clinical trial
- Open Access
- Study protocol
Tian-Tian Li, Zhao-Jun Wang, Song-Bai Yang, Jun-Hong Zhu, Shi-Zhong Zhang, San-Jin Cai, Wen-Han Ma, Ding-Qi Zhang, Zhi-Gang Mei
Safety and efficacy of colistin versus meropenem in the empirical treatment of ventilator-associated pneumonia as part of a macro-project funded by the Seventh Framework Program of the European Commission studying off-patent antibiotics: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Clara Rosso-Fernández, José Garnacho-Montero, Massimo Antonelli, George Dimopoulos, José Miguel Cisneros
Early warning scoring systems versus standard observations charts for wards in South Africa: a cluster randomized controlled trial
- Open Access
- Research
Una Kyriacos, Jennifer Jelsma, Michael James, Sue Jordan
Sharing data from clinical trials: the rationale for a controlled access approach
- Open Access
- Methodology
Matthew R Sydes, Anthony L Johnson, Sarah K Meredith, Mary Rauchenberger, Annabelle South, Mahesh KB Parmar
Hypertension management in primary care: study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Birgitta Weltermann, Anja Viehmann, Christine Kersting
Evaluator-blinded trial evaluating nurse-led immunotherapy DEcision Coaching In persons with relapsing-remitting Multiple Sclerosis (DECIMS) and accompanying process evaluation: study protocol for a cluster randomised controlled trial
- Open Access
- Study protocol
Anne Christin Rahn, Sascha Köpke, Jürgen Kasper, Eik Vettorazzi, Ingrid Mühlhauser, Christoph Heesen
Development of a composite outcome score for a complex intervention - measuring the impact of Community Health Workers
- Open Access
- Research
Hilary Watt, Matthew Harris, Jane Noyes, Rhiannon Whitaker, Zoe Hoare, Rhiannon Tudor Edwards, Andy Haines
Laser therapy for onychomycosis in patients with diabetes at risk for foot complications: study protocol for a randomized, double-blind, controlled trial (LASER-1)
- Open Access
- Study protocol
Leonie Nijenhuis-Rosien, Nanne Kleefstra, Maurice J Wolfhagen, Klaas H Groenier, Henk JG Bilo, Gijs WD Landman
Advancing Survivors’ Knowledge (ASK) about skin cancer study: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Casey L Daniel, Gregory T Armstrong, Robyn R Keske, Jessica A Davine, Aaron J McDonald, Kim M Sprunck-Harrild, Catherine Coleman, Sebastien J Haneuse, Ann C Mertens, Karen M Emmons, Ashfaq A Marghoob, Elena B Elkin, Stephen W Dusza, Leslie L Robison, Alan C Geller
Combining curcumin (C3-complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer (CUFOX): study protocol for a randomised control trial
- Open Access
- Study protocol
Glen RB Irving, Chinenye OO Iwuji, Bruno Morgan, David P Berry, William P Steward, Anne Thomas, Karen Brown, Lynne M Howells
The effectiveness of Tai Chi for patients with Parkinson’s disease: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Yan Yang, Yan-lei Hao, Wen-jing Tian, Li Gong, Kui Zhang, Qi-guang Shi, Da-fang Sun, Cui-lan Li, Zhi-ling Zhao
Comparing the effectiveness of an enhanced MOtiVational intErviewing InTervention (MOVE IT) with usual care for reducing cardiovascular risk in high risk subjects: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Adam Bayley, Nicole de Zoysa, Derek G Cook, Peter H Whincup, Daniel Stahl, Katherine Twist, Katie Ridge, Paul McCrone, Janet Treasure, Mark Ashworth, Anne Greenough, Clare Blythe, Kirsty Winkley, Khalida Ismail
The AvecNet Trial to assess whether addition of pyriproxyfen, an insect juvenile hormone mimic, to long-lasting insecticidal mosquito nets provides additional protection against clinical malaria over current best practice in an area with pyrethroid-resistant vectors in rural Burkina Faso: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Alfred B Tiono, Margaret Pinder, Sagnon N’Fale, Brian Faragher, Tom Smith, Mariabeth Silkey, Hilary Ranson, Steve W Lindsay
Extended brief intervention to address alcohol misuse in people with mild to moderate intellectual disabilities living in the community (EBI-ID): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Christos Kouimtsidis, Lucy Fodor-Wynne, Katrina Scior, Rachael Hunter, Gianluca Baio, Vittoria Pezzoni, Angela Hassiotis
Thyroxine in acute myocardial infarction (ThyrAMI) - levothyroxine in subclinical hypothyroidism post-acute myocardial infarction: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Avais Jabbar, Lorna Ingoe, Simon Pearce, Azfar Zaman, Salman Razvi
Trauma-focused cognitive behaviour therapy versus treatment as usual for post traumatic stress disorder (PTSD) in young children aged 3 to 8 years: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Tim Dalgleish, Benjamin Goodall, Isobel Chadwick, Aliza Werner-Seidler, Anna McKinnon, Nicola Morant, Susanne Schweizer, Inderpal Panesar, Ayla Humphrey, Peter Watson, Louise Lafortune, Patrick Smith, Richard Meiser-Stedman
Mixed methods feasibility study for a trial of blood pressure telemonitoring for people who have had stroke/transient ischaemic attack (TIA)
- Open Access
- Research
Janet Hanley, Peter Fairbrother, Ashma Krishan, Lucy McCloughan, Paul Padfield, Mary Paterson, Hilary Pinnock, Aziz Sheikh, Cathie Sudlow, Allison Todd, Brian McKinstry
Evaluating the efficacy, safety and evolution of renal function with early initiation of everolimus-facilitated tacrolimus reduction in de novo liver transplant recipients: Study protocol for a randomized controlled trial
- Open Access
- Study protocol
Bjorn Nashan, Peter Schemmer, Felix Braun, Markus Dworak, Peter Wimmer, Hans Schlitt
Electromagnetic guided bedside or endoscopic placement of nasoenteral feeding tubes in surgical patients (CORE trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Arja Gerritsen, Thijs de Rooij, Marcel G Dijkgraaf, Olivier R Busch, Jacques J Bergman, Dirk T Ubbink, Peter van Duijvendijk, G Willemien Erkelens, I Quintus Molenaar, Jan F Monkelbaan, Camiel Rosman, Adriaan C Tan, Philip M Kruyt, Dirk Jan Bac, Elisabeth M Mathus-Vliegen, Marc G Besselink
Effectiveness of dual-task functional power training for preventing falls in older people: study protocol for a cluster randomised controlled trial
- Open Access
- Study protocol
Robin M Daly, Rachel L Duckham, Jamie L Tait, Timo Rantalainen, Caryl A Nowson, Dennis R Taaffe, Kerrie Sanders, Keith D Hill, Dawson J Kidgell, Lucy Busija
Immune Function and Muscle Adaptations to Resistance exercise in Older Adults: Study Protocol for a Randomized Controlled Trial of a Nutritional Supplement
- Open Access
- Study protocol
Richard A Dennis, Usha Ponnappan, Ralph L Kodell, Kimberly K Garner, Christopher M Parkes, Melinda M Bopp, Kalpana P Padala, Charlotte A Peterson, Prasad R Padala, Dennis H Sullivan
Short-term study on risk-benefit outcomes of two spinal manipulative therapies in the treatment of acute radiculopathy caused by lumbar disc herniation: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Lei Han, Ping Zhao, Wei Guo, Jie Wei, Fei Wang, Yu Fan, Yi Li, Yaqing Min
Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jennifer Straatman, Nicole van der Wielen, Miguel A Cuesta, Suzanne S Gisbertz, Koen J Hartemink, Alfredo Alonso Poza, Jürgen Weitz, Fransico Mateo Vallejo, Khurshid Ahktar, Ismael Diez del Val, Josep Roig Garcia, Donald L van der Peet
Clinical effectiveness and micro-perfusion alteration of Jingui external lotion in patients with knee osteoarthritis: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Da Guo, Xue-Wei Cao, Jin-Wen Liu, Wei Niu, Zhen-Wei Ma, Ding-Kun Lin, Jia-Yi Chen, Wei-Dong Lian, Wen-Wei Ouyang, Jun Liu
Evaluation of a point-of-care tuberculosis test-and-treat algorithm on early mortality in people with HIV accessing antiretroviral therapy (TB Fast Track study): study protocol for a cluster randomised controlled trial
- Open Access
- Study protocol
Katherine L Fielding, Salome Charalambous, Christopher J Hoffmann, Suzanne Johnson, Mpho Tlali, Susan E Dorman, Anna Vassall, Gavin J Churchyard, Alison D Grant
Efficacy and safety of Ban-Lan-Gen granules in the treatment of seasonal influenza: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Zheng-tu Li, Li Li, Ting-ting Chen, Chu-yuan Li, De-qin Wang, Zi-feng Yang, Nan-shan Zhong
Effects of study design and allocation on self-reported alcohol consumption: randomized trial
- Open Access
- Methodology
Kypros Kypri, Amanda Wilson, John Attia, Paschal J Sheeran, Jim McCambridge
Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Felix J Hüttner, Tom Bruckner, Ingo Alldinger, Roland Hennes, Alexis Ulrich, Markus W Büchler, Markus K Diener, Phillip Knebel
The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial
- Open Access
- Study protocol
Shaikh Meshbahuddin Ahmad, Md Iqbal Hossain, Peter Bergman, Yearul Kabir, Rubhana Raqib
The POSE study - panic control treatment versus panic-focused psychodynamic psychotherapy under randomized and self-selection conditions: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Rolf Sandell, Martin Svensson, Thomas Nilsson, Håkan Johansson, Gardar Viborg, Sean Perrin
Electroacupuncture inhibits chronification of the acute pain of knee osteoarthritis: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Lin-lin Shen, Guo-fu Huang, Wen Tian, Ling-ling Yu, Xiao-cui Yuan, Zhao-qing Zhang, Jing Yin, Chao-yang Ma, Guo-wei Cai, Jian-wu Li, Ming-qiao Ding, Wei He, Xin-yan Gao, Bing Zhu, Xiang-hong Jing, Man Li
Optimizing early child development for young children with non-anemic iron deficiency in the primary care practice setting (OptEC): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Kawsari Abdullah, Kevin E Thorpe, Eva Mamak, Jonathon L Maguire, Catherine S Birken, Darcy Fehlings, Anthony J Hanley, Colin Macarthur, Stanley H Zlotkin, Patricia C Parkin
Study protocol for two randomized controlled trials examining the effectiveness and safety of current weekend allied health services and a new stakeholder-driven model for acute medical/surgical patients versus no weekend allied health services
- Open Access
- Study protocol
Terry P Haines, Lisa O’Brien, Deb Mitchell, Kelly-Ann Bowles, Romi Haas, Donna Markham, Samantha Plumb, Timothy Chiu, Kerry May, Kathleen Philip, David Lescai, Fiona McDermott, Mitchell Sarkies, Marcelle Ghaly, Leonie Shaw, Genevieve Juj, Elizabeth H Skinner
Fibromyalgia, milnacipran and experimental pain modulation: study protocol for a double blind randomized controlled trial
- Open Access
- Study protocol
Nicolas Macian, Bruno Pereira, Coralie Shinjo, Claude Dubray, Gisèle Pickering
A pilot feasibility, safety and biological efficacy multicentre trial of therapeutic hypercapnia after cardiac arrest: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Glenn M Eastwood, Antoine G Schneider, Satoshi Suzuki, Michael Bailey, Rinaldo Bellomo
Could enteral nutrition improve the outcome of patients with haematological malignancies undergoing allogeneic haematopoietic stem cell transplantation? A study protocol for a randomized controlled trial (the NEPHA study)
- Open Access
- Study protocol
Richard Lemal, Aurélie Cabrespine, Bruno Pereira, Cécile Combal, Aurélie Ravinet, Eric Hermet, Jacques-Olivier Bay, Corinne Bouteloup
Staff’s views on delivering patient-led therapy during inpatient stroke rehabilitation: a focus group study with lessons for trial fidelity
- Open Access
- Research
Maria Horne, Nessa Thomas, Andy Vail, Rudd Selles, Candy McCabe, Sarah Tyson
Assessing site performance in the Altair study, a multinational clinical trial
- Open Access
- Research
Nisha Berthon-Jones, Kymme Courtney-Vega, Anna Donaldson, Hila Haskelberg, Sean Emery, Rebekah Puls
Effect of cycle ergometer and conventional exercises on rehabilitation of older patients with total hip arthroplasty: study protocol for randomized controlled trial
- Open Access
- Study protocol
Mariana Kátia Rampazo-Lacativa, Maria José D’Elboux
SMS-based smoking cessation intervention among university students: study protocol for a randomised controlled trial (NEXit trial)
- Open Access
- Study protocol
Ulrika Müssener, Marcus Bendtsen, Nadine Karlsson, Ian R White, Jim McCambridge, Preben Bendtsen
Do clinical decision-support reminders for medical providers improve isoniazid preventative therapy prescription rates among HIV-positive adults?: study protocol for a randomized controlled trial
- Open Access
- STUDY PROTOCOL
Eric P Green, Caricia Catalani, Lameck Diero, E Jane Carter, Adrian Gardner, Charity Ndwiga, Aggrey Keny, Philip Owiti, Dennis Israelski, Paul Biondich
Surgeon, staff, and patient radiation exposure in minimally invasive transforaminal lumbar interbody fusion: impact of 3D fluoroscopy-based navigation partially replacing conventional fluoroscopy: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Ulrich Hubbe, Ronen Sircar, Christian Scheiwe, Christoph Scholz, Evangelos Kogias, Marie Therese Krüger, Florian Volz, Jan-Helge Klingler
Effects of weight management program on postural stability and neuromuscular function among obese children: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Fenghua Sun, Li-Juan Wang, Lin Wang
Action Seniors! - secondary falls prevention in community-dwelling senior fallers: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Teresa Liu-Ambrose, Jennifer C Davis, Chun Liang Hsu, Caitlin Gomez, Kelly Vertes, Carlo Marra, Penelope M Brasher, Elizabeth Dao, Karim M Khan, Wendy Cook, Meghan G Donaldson, Ryan Rhodes, Larry Dian
Effectiveness and feasibility of a software tool to help patients communicate with doctors about problems they face with their medication regimen (EMPATHy): study protocol for a randomized controlled trial
- Open Access
- Study protocol
John Billimek, Herlinda Guzman, Marco A Angulo
Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Xiao-Bing Yang, Wan-yin Wu, Shun-qin Long, Hong Deng, Zong-Qi Pan, Wen-Feng He, Yu-Shu Zhou, Gui-Ya Liao, Qiu-Ping Li, Shu-Jing Xiao, Jiao-Zhi Cai
The role of pre-existing cross-reactive antibodies in determining the efficacy of vaccination in humans: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jenny G Low, Limin Wijaya, Greg KY Li, Eleanor YL Lim, Aland KL Shum, Yin-Bun Cheung, Eng-Eong Ooi
A study protocol for a pilot randomised trial of a structured education programme for the self-management of Type 2 diabetes for adults with intellectual disabilities
- Open Access
- Study protocol
Laurence Taggart, Vivien Coates, Mike Clarke, Brendan Bunting, Melanie Davies, Marian Carey, Ruth Northway, Michael Brown, Maria Truesdale-Kennedy, Lorraine Martin-Stacey, Gillian Scott, Thanos Karatzias
Investigating the non-specific effects of BCG vaccination on the innate immune system in Ugandan neonates: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Sarah Prentice, Emily L Webb, Hazel M Dockrell, Pontiano Kaleebu, Alison M Elliott, Stephen Cose
Attention placebo control in randomized controlled trials of psychosocial interventions: theory and practice
- Open Access
- Letter
Lukka Popp, Silvia Schneider
The quantity-effect relationship and physiological mechanisms of different acupuncture manipulations on posterior circulation ischemia with vertigo: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Shi-Zhe Deng, Xiao-Feng Zhao, Ling-Hui Huang, Si He, Yan Wen, Chao Zhang, Guang Tian, Tian Wang, Fen-Fen Wu, Zhi-Hong Meng, Xue-Min Shi
Online parent-targeted cognitive-behavioural therapy intervention to improve quality of life in families of young cancer survivors: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Claire E Wakefield, Ursula M Sansom-Daly, Brittany C McGill, Maria McCarthy, Afaf Girgis, Martha Grootenhuis, Belinda Barton, Pandora Patterson, Michael Osborn, Cherie Lowe, Antoinette Anazodo, Gordon Miles, Richard J Cohn
Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Fredrika Norlund, Erik MG Olsson, Gunilla Burell, Emma Wallin, Claes Held
SMART: physical activity and cerebral metabolism in older people: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Johannes Fleckenstein, Silke Matura, Tobias Engeroff, Eszter Füzéki, Valentina A Tesky, Ulrich Pilatus, Elke Hattingen, Ralf Deichmann, Lutz Vogt, Winfried Banzer, Johannes Pantel
Quality of randomized controlled trials reporting in the treatment of melasma conducted in China
- Open Access
- Research
Zhiwei Chen, Yuchi Chen, Jingchun Zeng, Yang Wang, Teng Ye, Qiaochu Zhou, Xiaojing Du, Wenting Su, Zhishan Ding
Evaluating the effect of innovative motivation and supervision approaches on community health worker performance and retention in Uganda and Mozambique: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Karin Källander, Daniel Strachan, Seyi Soremekun, Zelee Hill, Raghu Lingam, James Tibenderana, Frida Kasteng, Anna Vassall, Sylvia Meek, Betty Kirkwood
Acupuncture for the treatment of phantom limb pain in lower limb amputees: study protocol for a randomized controlled feasibility trial
- Open Access
- Study protocol
Esmé G Trevelyan, Warren A Turner, Nicola Robinson
Vertebroplasty for acute painful osteoporotic fractures (VAPOUR): study protocol for a randomized controlled trial
- Open Access
- Study protocol
William Clark, Paul Bird, Terrence Diamond, Peter Gonski
A phase II study in advanced cancer patients to evaluate the early transition to palliative care (the PREPArE trial): protocol study for a randomized controlled trial
- Open Access
- Study protocol
Thamires Monteiro do Carmo, Bianca Sakamoto Ribeiro Paiva, Milena Ruas de Siqueira, Luciana de Toledo Bernardes da Rosa, Cleyton Zanardo de Oliveira, Maria Salete de Angelis Nascimento, Carlos Eduardo Paiva
Cognitive behavioral therapy for adults with attention-deficit hyperactivity disorder: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Fang Huang, Qiujin Qian, Yufeng Wang
Cardiac rehabilitation versus standard care after aortic aneurysm repair (Aneurysm CaRe): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Sandeep S Bahia, Peter J Holt, Kausik K Ray, Michael Ussher, Jan D Poloniecki, Rajan Sharma, Matthew J Bown, Robert J Hinchliffe, Matthew M Thompson, Alan Karthikesalingam
Study protocol for a randomised controlled trial of insulin delivery by continuous subcutaneous infusion compared to multiple daily injections
- Open Access
- Study protocol
Jo Blair, John W Gregory, Dyfrig Hughes, Colin H Ridyard, Carrol Gamble, Andrew McKay, Mohammed Didi, Keith Thornborough, Emma Bedson, Lola Awoyale, Emma Cwiklinski, Matthew Peak
Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Alonso Carrasco-Labra, Romina Brignardello-Petersen, Nancy Santesso, Ignacio Neumann, Reem A Mustafa, Lawrence Mbuagbaw, Itziar Etxeandia Ikobaltzeta, Catherine De Stio, Lauren J McCullagh, Pablo Alonso-Coello, Joerg J Meerpohl, Per Olav Vandvik, Jan L Brozek, Elie A Akl, Patrick Bossuyt, Rachel Churchill, Claire Glenton, Sarah Rosenbaum, Peter Tugwell, Vivian Welch, Gordon Guyatt, Holger Schünemann
Self-Help And Recovery guide for Eating Disorders (SHARED): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Valentina Cardi, Suman Ambwani, Ross Crosby, Pamela Macdonald, Gill Todd, Jinhong Park, Sara Moss, Ulrike Schmidt, Janet Treasure
Retention in physically demanding jobs of individuals with low back pain: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Bjarke Brandt Hansen, Lilli Kirkeskov, Robin Christensen, Luise Mølenberg Begtrup, Ellen Bøtker Pedersen, Jakob Falk Teilya, Mikael Boesen, Gilles Ludger Fournier, Henning Bliddal, Ann Isabel Kryger
Mindfulness-based exposure and response prevention for obsessive compulsive disorder: study protocol for a pilot randomised controlled trial
- Open Access
- Study protocol
Clara Strauss, Claire Rosten, Mark Hayward, Laura Lea, Elizabeth Forrester, Anna-Marie Jones
Exposure to persons with symptoms of respiratory or gastrointestinal infection and relative risk of disease: self-reported observations by controls in a randomized intervention trial
- Open Access
- Research
Tapani Hovi, Jukka Ollgren, Jaason Haapakoski, Ali Amiryousefi, Carita Savolainen-Kopra
Fibrinogen concentrate versus placebo for treatment of postpartum haemorrhage: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Nadine Aawar, Raza Alikhan, Daniel Bruynseels, Rebecca Cannings-John, Rachel Collis, John Dick, Christopher Elton, Roshan Fernando, Judith Hall, Kerry Hood, Nicki Lack, Shuba Mallaiah, Helena Maybury, Jacqueline Nuttall, Shantini Paranjothy, Rachel Rayment, Alexandra Rees, Julia Sanders, Julia Townson, Andrew Weeks, Peter Collins
Comparison of two strategies for initiating renal replacement therapy in the intensive care unit: study protocol for a randomized controlled trial (AKIKI)
- Open Access
- Study protocol
Stéphane Gaudry, David Hajage, Fréderique Schortgen, Laurent Martin-Lefevre, Florence Tubach, Bertrand Pons, Eric Boulet, Alexandre Boyer, Nicolas Lerolle, Guillaume Chevrel, Dorothée Carpentier, Alexandre Lautrette, Anne Bretagnol, Julien Mayaux, Marina Thirion, Philippe Markowicz, Guillemette Thomas, Jean Dellamonica, Jack Richecoeur, Michael Darmon, Nicolas de Prost, Hodane Yonis, Bruno Megarbane, Yann Loubières, Clarisse Blayau, Julien Maizel, Benjamin Zuber, Saad Nseir, Naïke Bigé, Isabelle Hoffmann, Jean-Damien Ricard, Didier Dreyfuss
DEFENS - Drug Exposure Feedback and Education for Nurses’ Safety: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Christopher R Friese, Kari Mendelsohn-Victor, Bo Wen, Duxin Sun, Kathleen Sutcliffe, James J Yang, David L Ronis, Marjorie C McCullagh
Quality of reporting on randomized controlled trials on recurrent spontaneous abortion in China
- Open Access
- Research
Jie Gao, Gaopi Deng, Yunyun Hu, Yanxi Huang, Liming Lu, Dandan Huang, Yadi Li, Lin Zhu, Xiaojing Liu, Xin Jin, Songping Luo
Bacteremia Antibiotic Length Actually Needed for Clinical Effectiveness (BALANCE): study protocol for a pilot randomized controlled trial
- Open Access
- Study protocol
Nick Daneman, Asgar H Rishu, Wei Xiong, Sean M Bagshaw, Deborah J Cook, Peter Dodek, Richard Hall, Anand Kumar, Francois Lamontagne, Francois Lauzier, John C Marshall, Claudio M Martin, Lauralyn McIntyre, John Muscedere, Steven Reynolds, Henry T Stelfox, Robert A Fowler
Neurofeedback as a nonpharmacological treatment for adults with attention-deficit/hyperactivity disorder (ADHD): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Kerstin Mayer, Sarah Nicole Wyckoff, Andreas J Fallgatter, Ann-Christine Ehlis, Ute Strehl
Weight bearing or non-weight bearing after surgically fixed ankle fractures, the WOW! Study: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jan Paul Briet, Roderick M Houwert, Diederik PJ Smeeing, Janity S Pawiroredjo, Johannes C Kelder, Koen W Lansink, Luke PH Leenen, Peer van der Zwaal, Stephan WAM van Zutphen, Jochem M Hoogendoorn, Mark van Heijl, Egbert JMM Verleisdonk, Guus W van Lammeren, Michiel J Segers, Falco Hietbrink
Tailored approaches to stroke health education (TASHE): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Joseph Ravenell, Ellyn Leighton-Herrmann, Amparo Abel-Bey, Alexandra DeSorbo, Jeanne Teresi, Lenfis Valdez, Madeleine Gordillo, William Gerin, Michael Hecht, Mildred Ramirez, James Noble, Elizabeth Cohn, Giardin Jean-Louis, Tanya Spruill, Salina Waddy, Gbenga Ogedegbe, Olajide Williams
Ketamine/propofol admixture (ketofol) at induction in the critically ill against etomidate (KEEP PACE trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Nathan J Smischney, Sumedh S Hoskote, Alice Gallo de Moraes, Carlos J Racedo Africano, Perliveh M Carrera, Rudy Tedja, Jasleen K Pannu, Elizabeth C Hassebroek, Dereddi Raja S Reddy, Richard F Hinds, Lokendra Thakur
Impact of a magnetic resonance imaging-guided treat-to-target strategy on disease activity and progression in patients with rheumatoid arthritis (the IMAGINE-RA trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Signe Møller-Bisgaard, Kim Hørslev-Petersen, Bo Jannik Ejbjerg, Mikael Boesen, Merete Lund Hetland, Robin Christensen, Jakob Møller, Niels Steen Krogh, Kristian Stengaard-Pedersen, Mikkel Østergaard
Adding a treatment arm to an ongoing clinical trial: a review of methodology and practice
- Open Access
- Review
Dena R Cohen, Susan Todd, Walter M Gregory, Julia M Brown
Person-centered care planning and service engagement: a study protocol for a randomized controlled trial
- Open Access
- Study protocol
Victoria Stanhope, Janis Tondora, Larry Davidson, Mimi Choy-Brown, Steven C Marcus
Investigating the effect of remote ischaemic preconditioning on biomarkers of stress and injury-related signalling in patients having isolated coronary artery bypass grafting or aortic valve replacement using cardiopulmonary bypass: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Francesca Fiorentino, Gianni D Angelini, M-Saadeh Suleiman, Alima Rahman, Jon Anderson, Alan J Bryan, Lucy A Culliford, Marco Moscarelli, Prakash P Punjabi, Barnaby C Reeves
Pulsed oral sirolimus in advanced autosomal-dominant polycystic kidney disease (Vienna RAP Study): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Markus Riegersperger, Harald Herkner, Gere Sunder-Plassmann
Sphenopalatine ganglion stimulation with one acupuncture needle for moderate-severe persistent allergic rhinitis: study protocol for a multicenter randomized controlled trial
- Open Access
- Study protocol
Lu Zhang, Lei Li, Da-Zhuo Shi, Lu-Quan Chen, Kai-Min Zheng, Kai Cheng, Ye Tao, Hai-Yan Guo, Shu-Liang Li, Jing Liu, Feng Xu, Jian-Wu Shen
Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Alessandra Solari, Andrea Giordano, Maria Grazia Grasso, Paolo Confalonieri, Francesco Patti, Alessandra Lugaresi, Lucia Palmisano, Roberta Amadeo, Giovanni Martino, Michela Ponzio, Giuseppe Casale, Claudia Borreani, Renzo Causarano, Simone Veronese, Paola Zaratin, Mario Alberto Battaglia
Preconditioning Shields Against Vascular Events in Surgery (SAVES), a multicentre feasibility trial of preconditioning against adverse events in major vascular surgery: study protocol for a randomised control trial
- Open Access
- Study protocol
Donagh Healy, Mary Clarke-Moloney, Brendan Gaughan, Siobhan O’Daly, Derek Hausenloy, Faisal Sharif, John Newell, Martin O’Donnell, Pierce Grace, John F Forbes, Walter Cullen, Eamon Kavanagh, Paul Burke, Simon Cross, Joseph Dowdall, Morgan McMonagle, Greg Fulton, Brian J Manning, Elrasheid AH Kheirelseid, Austin Leahy, Daragh Moneley, Peter Naughton, Emily Boyle, Seamus McHugh, Prakash Madhaven, Sean O’Neill, Zenia Martin, Donal Courtney, Muhammed Tubassam, Sherif Sultan, Damian McCartan, Mekki Medani, Stewart Walsh
Evaluation of a home-based transcranial direct current stimulation (tDCS) treatment device for chronic pain: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Francis O’Neill, Paul Sacco, Turo Nurmikko
The Lake Victoria island intervention study on worms and allergy-related diseases (LaVIISWA): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Margaret Nampijja, Emily L Webb, James Kaweesa, Robert Kizindo, Milly Namutebi, Esther Nakazibwe, Gloria Oduru, Prossy Kabuubi, Joyce Kabagenyi, Dennison Kizito, Lawrence Muhangi, Mirriam Akello, Jaco J Verweij, Barbara Nerima, Edridah Tukahebwa, Alison M Elliott
Effect of diuretics and sodium-restricted diet on sleep apnea severity: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Cintia Zappe Fiori, Denis Martinez, Sandro Cadaval Gonçalves, Carolina Caruccio Montanari, Flavio Danni Fuchs
Personalized versus standardized dosing strategies for the treatment of childhood amblyopia: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Merrick J Moseley, Michael P Wallace, David A Stephens, Alistair R Fielder, Laura C Smith, Catherine E Stewart
A little more conversation please? Qualitative study of researchers’ and patients’ interview accounts of training for patient and public involvement in clinical trials
- Open Access
- Research
Louise Dudley, Carrol Gamble, Alison Allam, Philip Bell, Deborah Buck, Heather Goodare, Bec Hanley, Jennifer Preston, Alison Walker, Paula Williamson, Bridget Young
The effect of an information and communication technology (ICT) on older adults’ quality of life: study protocol for a randomized control trial
- Open Access
- Study protocol
David H Gustafson Sr., Fiona McTavish, David H Gustafson Jr., Jane E Mahoney, Roberta A Johnson, John D Lee, Andrew Quanbeck, Amy K Atwood, Andrew Isham, Raj Veeramani, Lindy Clemson, Dhavan Shah
Effects of traditional Chinese medicine Shu Gan Jian Pi granules on patients with breast cancer and cancer-related fatigue: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Chen Li, GuoWang Yang, MingWei Yu, YongMei Xu, Na Xue, Nan Nan, XiaoMin Wang
Rationale and study design for an individualized perioperative open lung ventilatory strategy (iPROVE): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Carlos Ferrando, Marina Soro, Jaume Canet, Ma Carmen Unzueta, Fernando Suárez, Julián Librero, Salvador Peiró, Alicia Llombart, Carlos Delgado, Irene León, Lucas Rovira, Fernando Ramasco, Manuel Granell, César Aldecoa, Oscar Diaz, Jaume Balust, Ignacio Garutti, Manuel de la Matta, Alberto Pensado, Rafael Gonzalez, Mª Eugenia Durán, Lucia Gallego, Santiago García del Valle, Francisco J Redondo, Pedro Diaz, David Pestaña, Aurelio Rodríguez, Javier Aguirre, Jose M García, Javier García, Elena Espinosa, Pedro Charco, Jose Navarro, Clara Rodríguez, Gerardo Tusman, Francisco Javier Belda
Muscular and functional effects of partitioning exercising muscle mass in patients with chronic obstructive pulmonary disease - a study protocol for a randomized controlled trial
- Open Access
- Study protocol
Andrè Nyberg, Didier Saey, Mickaël Martin, François Maltais
To assess whether addition of pyriproxyfen to long-lasting insecticidal mosquito nets increases their durability compared to standard long-lasting insecticidal mosquito nets: study protocol for a randomised controlled trial
- Open Access
- Study protocol
N’Fale Sagnon, Margaret Pinder, Emile FS Tchicaya, Alfred B Tiono, Brian Faragher, Hilary Ranson, Steve W Lindsay
PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Jan Cameron, Peter G Rendell, Chantal F Ski, Christina E Kure, Skye N McLennan, Nathan S Rose, David L Prior, David R Thompson
Peanut oral immunotherapy in adolescents: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Elodie Michaud, Bertrand Evrard, Bruno Pereira, Emmanuelle Rochette, Lise Bernard, Paul-Olivier Rouzaire, Nelly Gourdon-Dubois, Etienne Merlin, Jean-Luc Fauquert
Influence of Morphine on Pharmacokinetics and Pharmacodynamics of Ticagrelor in Patients with Acute Myocardial Infarction (IMPRESSION): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jacek Kubica, Piotr Adamski, Małgorzata Ostrowska, Marek Koziński, Karolina Obońska, Ewa Laskowska, Ewa Obońska, Grzegorz Grześk, Piotr Winiarski, Przemysław Paciorek
The efficacy and safety of the Chinese herbal medicine Di-Tan decoction for treating Alzheimer’s disease: protocol for a randomized controlled trial
- Open Access
- Study protocol
Ka-Kit Chua, Adrian Wong, Pauline Wing-Lam Kwan, Ju-Xian Song, Lei-Lei Chen, Andrew Lung-Tat Chan, Jia-Hong Lu, Vincent Mok, Min Li
Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Ying-Ying Leung, Julian Thumboo, Bak Siew Wong, Ben Haaland, Balram Chowbay, Bibhas Chakraborty, Mann Hong Tan, Virginia B Kraus
BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jiang-ming Chen, Wei Geng, Fu-bao Liu, Hong-chuan Zhao, Sheng-xue Xie, Hui Hou, Yi-jun Zhao, Guo-bin Wang, Xiao-ping Geng
Impact of withholding early parenteral nutrition completing enteral nutrition in pediatric critically ill patients (PEPaNIC trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Tom Fivez, Dorian Kerklaan, Sascha Verbruggen, Ilse Vanhorebeek, Sören Verstraete, Dick Tibboel, Gonzalo Garcia Guerra, Pieter J Wouters, Ari Joffe, Koen Joosten, Dieter Mesotten, Greet Van den Berghe
An internet-based adolescent depression preventive intervention: study protocol for a randomized control trial
- Open Access
- Study protocol
Tracy G Gladstone, Monika Marko-Holguin, Phyllis Rothberg, Jennifer Nidetz, Anne Diehl, Daniela T DeFrino, Mary Harris, Eumene Ching, Milton Eder, Jason Canel, Carl Bell, William R Beardslee, C Hendricks Brown, Kathleen Griffiths, Benjamin W Van Voorhees
Criteria for Reporting the Development and Evaluation of Complex Interventions in healthcare: revised guideline (CReDECI 2)
- Open Access
- Methodology
Ralph Möhler, Sascha Köpke, Gabriele Meyer
Evaluating an extended rehabilitation service for stroke patients (EXTRAS): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Helen Rodgers, Lisa Shaw, Robin Cant, Avril Drummond, Gary A Ford, Anne Forster, Katie Hills, Denise Howel, Anne-Marie Laverty, Christopher McKevitt, Peter McMeekin, Christopher Price
Challenges to undertaking randomised trials with looked after children in social care settings
- Open Access
- Research
Gillian Mezey, Fiona Robinson, Rona Campbell, Steve Gillard, Geraldine Macdonald, Deborah Meyer, Chris Bonell, Sarah White
DRAPA trial – closed-suction drains versus closed gravity drains in pancreatic surgery: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Filip Čečka, Martin Loveček, Bohumil Jon, Pavel Skalický, Zdeněk Šubrt, Alexander Ferko
ALIFE2 study: low-molecular-weight heparin for women with recurrent miscarriage and inherited thrombophilia - study protocol for a randomized controlled trial
- Open Access
- Study protocol
Paulien G de Jong, Siobhan Quenby, Kitty WM Bloemenkamp, Babette AM Braams-Lisman, Jan Peter de Bruin, Arri Coomarasamy, Michele David, Maria T DeSancho, Olivier WH van der Heijden, Annemieke Hoek, Barbara A Hutten, Kristin Jochmans, Carolien AM Koks, Walter KH Kuchenbecker, Ben Willem J Mol, Helen L Torrance, Hubertina CJ Scheepers, Mary D Stephenson, Harold R Verhoeve, Jantien Visser, Johanna IP de Vries, Mariëtte Goddijn, Saskia Middeldorp
Testing the feasibility of a mobile technology intervention promoting healthy gestational weight gain in pregnant women (txt4two) - study protocol for a randomised controlled trial
- Open Access
- Study protocol
Jane Catherine Willcox, Karen Jane Campbell, Elizabeth Anne McCarthy, Shelley Ann Wilkinson, Martha Lappas, Kylie Ball, Brianna Fjeldsoe, Anne Griffiths, Robyn Whittaker, Ralph Maddison, Alexis Shub, Deborah Pidd, Elise Fraser, Nelly Moshonas, David Andrew Crawford
The CSAW Study (Can Shoulder Arthroscopy Work?) – a placebo-controlled surgical intervention trial assessing the clinical and cost effectiveness of arthroscopic subacromial decompression for shoulder pain: study protocol for a randomised controlled trial
- Open Access
- Study protocol
David Beard, Jonathan Rees, Ines Rombach, Cushla Cooper, Jonathan Cook, Naomi Merritt, Alastair Gray, Stephen Gwilym, Andrew Judge, Julian Savulescu, Jane Moser, Jenny Donovan, Marcus Jepson, Caroline Wilson, Irene Tracey, Karolina Wartolowska, Benjamin Dean, Andrew Carr
SWAT-1: The effectiveness of a ‘site visit’ intervention on recruitment rates in a multi-centre randomised trial
- Open Access
- Research
Valerie Smith, Mike Clarke, Cecily Begley, Declan Devane
Efficacy and safety of electroacupuncture with different acupoints for chemotherapy-induced nausea and vomiting: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Bo Chen, Shu-xiang Hu, Bao-hu Liu, Tian-yi Zhao, Bo Li, Yan Liu, Ming-yue Li, Xing-fang Pan, Yong-ming Guo, Ze-lin Chen, Yi Guo
A sample size planning approach that considers both statistical significance and clinical significance
- Open Access
- Methodology
Bin Jia, Henry S Lynn
Successful knowledge translation intervention in long-term care: final results from the vitamin D and osteoporosis study (ViDOS) pilot cluster randomized controlled trial
- Open Access
- Research
Courtney C Kennedy, George Ioannidis, Lehana Thabane, Jonathan D Adachi, Sharon Marr, Lora M Giangregorio, Suzanne N Morin, Richard G Crilly, Robert G Josse, Lynne Lohfeld, Laura E Pickard, Mary-Lou van der Horst, Glenda Campbell, Jackie Stroud, Lisa Dolovich, Anna M Sawka, Ravi Jain, Lynn Nash, Alexandra Papaioannou
What is the effect of a formalised trauma tertiary survey procedure on missed injury rates in multi-trauma patients? Study protocol for a randomised controlled trial
- Open Access
- Study protocol
Gerben B Keijzers, Chris Del Mar, Leo M G Geeraedts Jr, Joshua Byrnes, Elaine M Beller
Effect of laser acupuncture on obesity: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Chi-Chuan Tseng, Alan Tseng, Chia-Hao Chang
Evaluating early administration of the hydroxymethylglutaryl-CoA reductase inhibitor simvastatin in the prevention and treatment of delirium in critically ill ventilated patients (MoDUS trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Annalisa Casarin, Daniel F McAuley, Timothy M Alce, Xiaobei Zhao, E Wesley Ely, Jim C Jackson, Cliona McDowell, Ashley Agus, Lynn Murphy, Valerie J Page
Efficacy and safety of Gantong Granules in the treatment of common cold with wind-heat syndrome: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jie Min, Xiao-qiang Li, Bin She, Yan Chen, Bing Mao
Evaluating the safety and efficacy of recombinant human thrombopoietin among severe sepsis patients with thrombocytopenia: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Qin Wu, Jianan Ren, Gefei Wang, Guosheng Gu, Dong Hu, Song Liu, Gunawei Li, Jun Chen, Ranran Li, Zhiwu Hong, Huajian Ren, Xiuwen Wu, Yuan Li, Min Yao, Yunzhao Zhao, Jieshou Li
A pilot effectiveness study of the Enhancing Parenting Skills (EPaS) 2014 programme for parents of children with behaviour problems: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Margiad Elen Williams, Judy Hutchings
Clinical assessment of Shenfu injection loading in the treatment of patients with exacerbation of chronic heart failure due to coronary heart disease: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Chunxiang Liu, Yazhu Hou, Xianliang Wang, Zhiqiang Zhao, Zhi Liu, Jingbo Zhai, Jingyuan Mao, Hongcai Shang
MEDUCATE trial: effectiveness of an intensive EDUCATional intervention for IT-mediated MEDication management in the outpatient clinic – study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
F. van Stiphout, J.E.F Zwart-van Rijkom, J.E.C.M. Aarts, H. Koffijberg, E. Klarenbeek-deJonge, M. Krulder, K.C.B. Roes, A.C.G. Egberts, E.W.M.T. ter Braak
Comparison of two surgical methods for the treatment of CIN: classical LLETZ (large-loop excision of the transformation zone) versus isolated resection of the colposcopic apparent lesion – study protocol for a randomized controlled trial
- Open Access
- Study protocol
Theresa M. Schwarz, Thomas Kolben, Julia Gallwas, Alexander Crispin, Christian Dannecker
PReVENT - protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Fabienne D. Simonis, Jan M. Binnekade, Annemarije Braber, Harry P. Gelissen, Jeroen Heidt, Janneke Horn, Gerard Innemee, Evert de Jonge, Nicole P. Juffermans, Peter E. Spronk, Lotte M. Steuten, Pieter Roel Tuinman, Marijn Vriends, Gwendolyn de Vreede, Rob B. de Wilde, Ary Serpa Neto, Marcelo Gama de Abreu, Paolo Pelosi, Marcus J. Schultz
Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Marlos Rodrigues Domingues, Diego Garcia Bassani, Shana Ginar da Silva, Carolina de Vargas Nunes Coll, Bruna Gonçalves Cordeiro da Silva, Pedro Curi Hallal
Evaluation of a hospital-based day-structuring exercise programme on exacerbated behavioural and psychological symptoms in dementia - the exercise carrousel: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Tim Fleiner, Wiebren Zijlstra, Hannah Dauth, Peter Haussermann
Antimicrobial photodynamic therapy combined with periodontal treatment for metabolic control in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Erika Elisabeth Evangelista, Cristiane Miranda França, Priscila Veni, Tamires de Oliveira Silva, Rafael Moredo Gonçalves, Verônica Franco de Carvalho, Alessandro Melo Deana, Kristianne P S Fernandes, Raquel A Mesquita-Ferrari, Cleber P Camacho, Sandra Kalil Bussadori, Letícia Heineck Alvarenga, Renato Araujo Prates
A mother-child intervention program in adolescent mothers and their children to improve maternal sensitivity, child responsiveness and child development (the TeeMo study): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Christine Firk, Brigitte Dahmen, Christin Lehmann, Anke Niessen, Julia Koslowski, Geraldine Rauch, Reinhild Schwarte, Kerstin Stich, Kerstin Konrad, Beate Herpertz-Dahlmann
Impact of a web-based treatment decision aid for early-stage prostate cancer on shared decision-making and health outcomes: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Maarten Cuypers, Romy E. D. Lamers, Paul J. M. Kil, Lonneke V. van de Poll-Franse, Marieke de Vries
Electroacupuncture for older adults with mild cognitive impairment: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Albert Wing Nang Leung, Linda Chiu Wa Lam, Andrew Ka Lun Kwan, Celia Lai Lin Tsang, Hong Wei Zhang, Yuan Qi Guo, Chuan Shan Xu
Effect of manual versus mechanically assisted manipulations of the thoracic spine in neck pain patients: study protocol of a randomized controlled trial
- Open Access
- Study protocol
Anke Langenfeld, B. Kim Humphreys, Rob A. de Bie, Jaap Swanenburg
CON-COUR study: Interferential therapy in the treatment of chronic constipation in adults: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Véronique Vitton, Alban Benezech, Stéphane Honoré, Patrick Sudour, Nathalie Lesavre, Pascal Auquier, Karine Baumstarck
Reliability of photographic analysis of wound epithelialization assessed in human skin graft donor sites and epidermolysis bullosa wounds
- Open Access
- Research
Hans-Oliver Rennekampff, Rolf Fimmers, Hans-Robert Metelmann, Hauke Schumann, Mayer Tenenhaus
Effects of cognitive behavioural therapy for insomnia on the mental health of university students: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Daniel Freeman, Bryony Sheaves, Guy M. Goodwin, Ly-Mee Yu, Paul J. Harrison, Richard Emsley, Sophie Bostock, Russell G. Foster, Vanashree Wadekar, Christopher Hinds, Colin A. Espie
An oral health education video game for high caries risk children: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Ahmad Aljafari, Colm Rice, Jennifer Elizabeth Gallagher, Marie Therese Hosey
Low-dose capecitabine adjuvant chemotherapy in elderly stage II/III colorectal cancer patients (LC-ACEC): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Yazhou He, Ping Liu, Yuanchuan Zhang, Xiangbing Deng, Wenjian Meng, Mingtian Wei, Tinghan Yang, Ziqiang Wang, Meng Qiu
Effects of a DPP4 inhibitor on cisplatin-induced acute kidney injury: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Seon Ha Baek, Se Hyun Kim, Jin Won Kim, Yu Jung Kim, Keun-Wook Lee, Ki Young Na
Intraoperative brief electrical stimulation (BES) for prevention of shoulder dysfunction after oncologic neck dissection: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Brittany Barber, Margaret McNeely, K. Ming Chan, Rhys Beaudry, Jaret Olson, Jeffrey Harris, Hadi Seikaly, Daniel O’Connell
A systematic review of the use of an expertise-based randomised controlled trial design
- Open Access
- Methodology
Jonathan A. Cook, Andrew Elders, Charles Boachie, Ted Bassinga, Cynthia Fraser, Doug G. Altman, Isabelle Boutron, Craig R. Ramsay, Graeme S. MacLennan
Explaining high and low performers in complex intervention trials: a new model based on diffusion of innovations theory
- Open Access
- Research
Heather McMullen, Chris Griffiths, Werner Leber, Trisha Greenhalgh
CONSORT in China: past development and future direction
- Open Access
- Review
Tian-Jiao Song, Hou-Fu Leng, Linda LD Zhong, Tai-Xiang Wu, Zhao-Xiang Bian
Telephone-based goal management training for adults with mild traumatic brain injury: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Kristin R Archer, Rogelio A Coronado, Lori R Haislip, Christine M Abraham, Susan W Vanston, Anthony E Lazaro, James C Jackson, E Wesley Ely, Oscar D Guillamondegui, William T Obremskey
Evaluating processes of care and outcomes of children in hospital (EPOCH): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Christopher S. Parshuram, Karen Dryden-Palmer, Catherine Farrell, Ronald Gottesman, Martin Gray, James S. Hutchison, Mark Helfaer, Elizabeth Hunt, Ari Joffe, Jacques Lacroix, Vinay Nadkarni, Patricia Parkin, David Wensley, Andrew R Willan
Acupuncture for the sequelae of Bell’s palsy: a randomized controlled trial
- Open Access
- Research
Hyo-Jung Kwon, Jun-Yong Choi, Myeong Soo Lee, Yong-Suk Kim, Byung-Cheul Shin, Jong-In Kim
The Beyond Ageing Project Phase 2 - a double-blind, selective prevention, randomised, placebo-controlled trial of omega-3 fatty acids and sertraline in an older age cohort at risk for depression: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Nicole L. Cockayne, Shantel L. Duffy, Rosalind Bonomally, Amelia English, Paul G. Amminger, Andrew Mackinnon, Helen M. Christensen, Sharon L. Naismith, Ian B. Hickie
Electro-acupuncture for treatment of knee pain from osteoarthritis and the possible endocrinology changes: a study protocol for a randomized controlled trial
- Open Access
- Study protocol
Javier Mata, Sandra Cabrera, Pilar Sanchís, Pedro Valentí, Patricia Hernández, Regina Fortuny, Serafin Lirola, Jose Luis Aguilar
Titanium versus absorbable tacks comparative study (TACS): a multicenter, non-inferiority prospective evaluation during laparoscopic repair of ventral and incisional hernia: study protocol for randomized controlled trial
- Open Access
- Study protocol
Gianfranco Silecchia, Giuseppe Cavallaro, Luigi Raparelli, Stefano Olmi, Gianandrea Baldazzi, Fabio Cesare Campanile
Mixed response and time-to-event endpoints for multistage single-arm phase II design
- Open Access
- Research
Xin Lai, Benny Chung-Ying Zee
Evaluating rehabilitation following lumbar fusion surgery (REFS): study protocol for a randomised controlled trial
- Open Access
- Study protocol
James Greenwood, Alison McGregor, Fiona Jones, Michael Hurley
Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Mariana Moreira da Silva, Regiane Albertini, Ernesto Cesar Pinto Leal-Junior, Paulo de Tarso Camillo de Carvalho, José Antonio Silva Jr, Sandra Kalil Bussadori, Luis Vicente Franco de Oliveira, Cezar Augusto Souza Casarin, Erinaldo Luiz Andrade, Danilo Sales Bocalini, Andrey Jorge Serra
Improving quality of care and long-term health outcomes through continuity of care with the use of an electronic or paper patient-held portable health file (COMMUNICATE): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Marissa Nichole Lassere, Sue Baker, Andrew Parle, Anthony Sara, Kent Robert Johnson
PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Toby Richards, Ben Clevenger, Jane Keidan, Tim Collier, Andrew A. Klein, Stefan D. Anker, John D. Kelly
Patterned feeding experience for preterm infants: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Rita H. Pickler, Paul A. Wetzel, Jareen Meinzen-Derr, Heather L. Tubbs-Cooley, Margo Moore
Head Position in Stroke Trial (HeadPoST) – sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial
- Open Access
- Study protocol
Paula Muñoz-Venturelli, Hisatomi Arima, Pablo Lavados, Alejandro Brunser, Bin Peng, Liying Cui, Lily Song, Laurent Billot, Elizabeth Boaden, Maree L. Hackett, Stephane Heritier, Stephen Jan, Sandy Middleton, Verónica V. Olavarría, Joyce Y. Lim, Richard I. Lindley, Emma Heeley, Thompson Robinson, Octavio Pontes-Neto, Lkhamtsoo Natsagdorj, Ruey-Tay Lin, Caroline Watkins, Craig S. Anderson
Newborn Infection Control and Care Initiative for health facilities to accelerate reduction of newborn mortality (NICCI): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Chivorn Var, Alessandra N Bazzano, Sudesh K. Srivastav, James C Welty, Navapol Iv Ek, Richard A Oberhelman
Who does not participate in telehealth trials and why? A cross-sectional survey
- Open Access
- Research
Alexis Foster, Kimberley A Horspool, Louisa Edwards, Clare L Thomas, Chris Salisbury, Alan A Montgomery, Alicia O’Cathain
Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain
- Open Access
- Research
M. Ram Gudavalli, Stacie A. Salsbury, Robert D. Vining, Cynthia R. Long, Lance Corber, Avinash G. Patwardhan, Christine M. Goertz
Clinical effectiveness of an ultra-brief intervention for common mental health syndromes in primary care: study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Sunny Collings, Fiona Mathieson, Anthony Dowell, James Stanley, Simon Hatcher, Felicity Goodyear-Smith, Brigitte Lane, Amy Munsterman
Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform
- Open Access
- Methodology
Shaun Treweek, Doug G. Altman, Peter Bower, Marion Campbell, Iain Chalmers, Seonaidh Cotton, Peter Craig, David Crosby, Peter Davidson, Declan Devane, Lelia Duley, Janet Dunn, Diana Elbourne, Barbara Farrell, Carrol Gamble, Katie Gillies, Kerry Hood, Trudie Lang, Roberta Littleford, Kirsty Loudon, Alison McDonald, Gladys McPherson, Annmarie Nelson, John Norrie, Craig Ramsay, Peter Sandercock, Daniel R Shanahan, William Summerskill, Matt Sydes, Paula Williamson, Mike Clarke
A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Juliane Menting, Stephanie Nikolaus, Jan-Frederic Wiborg, Ellen Bazelmans, Martine M. Goedendorp, Arianne C. van Bon, Joop P. van den Bergh, Marc JTM. Mol, Cees J. Tack, Hans Knoop
The NAtional randomised controlled Trial of Tonsillectomy IN Adults (NATTINA): a clinical and cost-effectiveness study: study protocol for a randomised control trial
- Open Access
- Study protocol
Isabel Rubie, Catherine Haighton, James O’Hara, Nikki Rousseau, Nick Steen, Deborah D. Stocken, Frank Sullivan, Luke Vale, Scott Wilkes, Janet Wilson
High-dose single-fraction IMRT versus fractionated external beam radiotherapy for patients with spinal bone metastases: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Harald Rief, Sonja Katayama, Thomas Bruckner, Stefan Rieken, Tilman Bostel, Robert Förster, Ingmar Schlampp, Robert Wolf, Jürgen Debus, Florian Sterzing
Pulsed electromagnetic fields for postmenopausal osteoporosis and concomitant lumbar osteoarthritis in southwest China using proximal femur bone mineral density as the primary endpoint: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Hui-Fang Liu, Hong-Chen He, Lin Yang, Zhou-Yuan Yang, Ke Yao, Yuan-Chao Wu, Xi-Biao Yang, Cheng-Qi He
A consumer-targeted, pharmacist-led, educational intervention to reduce inappropriate medication use in community older adults (D-PRESCRIBE trial): study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Philippe Martin, Robyn Tamblyn, Sara Ahmed, Andrea Benedetti, Cara Tannenbaum
Use of low-dose oral theophylline as an adjunct to inhaled corticosteroids in preventing exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Graham Devereux, Seonaidh Cotton, Peter Barnes, Andrew Briggs, Graham Burns, Rekha Chaudhuri, Henry Chrystyn, Lisa Davies, Anthony De Soyza, Shona Fielding, Simon Gompertz, John Haughney, Amanda J. Lee, Kirsty McCormack, Gladys McPherson, Alyn Morice, John Norrie, Anita Sullivan, Andrew Wilson, David Price
Development of an internationally agreed minimal dataset for juvenile dermatomyositis (JDM) for clinical and research use
- Open Access
- Study protocol
Liza J. McCann, Jamie J. Kirkham, Lucy R. Wedderburn, Clarissa Pilkington, Adam M. Huber, Angelo Ravelli, Duncan Appelbe, Paula R. Williamson, Michael W. Beresford
Self-management education for adults with poorly controlled epilepsy (SMILE (UK)): statistical, economic and qualitative analysis plan for a randomised controlled trial
- Open Access
- Update
Nicholas Magill, Leone Ridsdale, Laura H. Goldstein, Paul McCrone, Myfanwy Morgan, Adam J. Noble, Gus Baker, Mark Richardson, Stephanie Taylor, Sabine Landau
Effects of motivational interviewing-based adherence therapy for schizophrenia spectrum disorders: a randomized controlled trial
- Open Access
- Research
Wai Tong Chien, Jolene HC Mui, Eric FC Cheung, Richard Gray
Comparing the efficacy of a web-assisted calprotectin-based treatment algorithm (IBD-live) with usual practices in teenagers with inflammatory bowel disease: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Anke Heida, Alie Dijkstra, Henk Groen, Anneke Muller Kobold, Henkjan Verkade, Patrick van Rheenen
The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jia Huang, Zhengkun Lin, Qin Wang, Feiwen Liu, Jiao Liu, Yunhua Fang, Shanjia Chen, Xiaoxuan Zhou, Wenjun Hong, Jinsong Wu, Natalia Madrigal-Mora, Guohua Zheng, Shanli Yang, Jing Tao, Lidian Chen
Does pragmatically structured outpatient dietary counselling reduce sodium intake in hypertensive patients? Study protocol for a randomized controlled trial
- Open Access
- Study protocol
Marcel Ruzicka, Tim Ramsay, Ann Bugeja, Cedric Edwards, George Fodor, Anne Kirby, Peter Magner, Brendan McCormick, Gigi van der Hoef, Jessica Wagner, Swapnil Hiremath
TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial
- Open Access
- Study protocol
Dylan R. Morris, Margaret A. Cunningham, Anna A. Ahimastos, Bronwyn A. Kingwell, Elise Pappas, Michael Bourke, Christopher M. Reid, Theo Stijnen, Ronald L. Dalman, Oliver O. Aalami, Jan H. Lindeman, Paul E. Norman, Philip J. Walker, Robert Fitridge, Bernie Bourke, Anthony E. Dear, Jenna Pinchbeck, Rene Jaeggi, Jonathan Golledge
Outcome reporting in randomised controlled trials and meta-analyses of appendicitis treatments in children: a systematic review
- Open Access
- Research
Nigel J. Hall, Mufiza Z. Kapadia, Simon Eaton, Winnie W. Y. Chan, Cheri Nickel, Agostino Pierro, Martin Offringa
AMBITION-cm: intermittent high dose AmBisome on a high dose fluconazole backbone for cryptococcal meningitis induction therapy in sub-Saharan Africa: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Mooketsi Molefi, Awilly A. Chofle, Síle F. Molloy, Samuel Kalluvya, John M. Changalucha, Francesca Cainelli, Tshepo Leeme, Nametso Lekwape, Drew W. Goldberg, Miriam Haverkamp, Gregory P. Bisson, John R. Perfect, Emili Letang, Lukas Fenner, Graeme Meintjes, Rosie Burton, Tariro Makadzange, Chiratidzo E. Ndhlovu, William Hope, Thomas S. Harrison, Joseph N. Jarvis
Rehab-let: touchscreen tablet for self-training impaired dexterity post stroke: study protocol for a pilot randomized controlled trial
- Open Access
- Study protocol
Debbie Rand, Gabi Zeilig, Rachel Kizony
Population-centered Risk- and Evidence-based Dental Interprofessional Care Team (PREDICT): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Joana Cunha-Cruz, Peter Milgrom, R. Michael Shirtcliff, Howard L. Bailit, Colleen E. Huebner, Douglas Conrad, Sharity Ludwig, Melissa Mitchell, Jeanne Dysert, Gary Allen, JoAnna Scott, Lloyd Mancl
Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Renly Lim, Men Long Liong, Wing Seng Leong, Nurzalina Abdul Karim Khan, Kah Hay Yuen
Individual Placement and Support supplemented with cognitive remediation and work-related social skills training in Denmark: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Thomas Nordahl Christensen, Iben Gammelgaard Nielsen, Elsebeth Stenager, Britt Reuter Morthorst, Jane Lindschou, Merete Nordentoft, Lene Falgaard Eplov
People-centered tuberculosis care versus standard directly observed therapy: study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Vahe Khachadourian, Nune Truzyan, Arusyak Harutyunyan, Michael E. Thompson, Tsovinar Harutyunyan, Varduhi Petrosyan
PREventing Delayed Graft Function by Driving Immunosuppressive InduCtion Treatment (PREDICT-DGF): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Marion Chapal, Yohann Foucher, Monique Marguerite, Karine Neau, Emmanuelle Papuchon, Pascal Daguin, Emmanuel Morélon, Georges Mourad, Elisabeth Cassuto, Marc Ladrière, Christophe Legendre, Magali Giral
BEWARE: Body awareness training in the treatment of wearing-off related anxiety in patients with Parkinson’s disease: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Ires Ghielen, Odile A. van den Heuvel, Cees J. T. de Goede, Marieke Houniet-de Gier, Emma H. Collette, Ingrid A. L. Burgers-Bots, Sonja Rutten, Gert Kwakkel, Kees Vermunt, Bep van Vliet, Henk W. Berendse, Erwin E. H. van Wegen
Improving care after colon cancer treatment in The Netherlands, personalised care to enhance quality of life (I CARE study): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Laura A.M. Duineveld, Thijs Wieldraaijer, Kristel M. van Asselt, Ineke C. Nugteren, Sandra C. Donkervoort, Anthony W.H. van de Ven, Anke B. Smits, Anna A.W. van Geloven, Willem A. Bemelman, Frederique H. Beverdam, Willem F. van Tets, Marc J.P.M. Govaert, Judith E. Bosmans, Irma M. Verdonck-de Leeuw, Cornelia F. van Uden-Kraan, Henk C.P.M. van Weert, Jan Wind
Effect of heating and cooling combination therapy on patients with chronic low back pain: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Eun-Jung Kim, Young-Doo Choi, Chi-Yeon Lim, Kyung-Ho Kim, Seung-Deok Lee
Impact of an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes on decisional conflict – study protocol for a randomized controlled trial
- Open Access
- Study protocol
Catherine H. Yu, Noah M. Ivers, Dawn Stacey, Jeremy Rezmovitz, Deanna Telner, Kevin Thorpe, Susan Hall, Marc Settino, David M. Kaplan, Michael Coons, Sumeet Sodhi, Joanna Sale, Sharon E. Straus
Immediate help through group therapy for patients with somatic diseases and depressive or adjustment disorders in outpatient care: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Miriam Ruesch, Almut Wiebke Helmes, Juergen Bengel
Passive movement and active exercise for very young infants with congenital heart disease: a study protocol for a randomized controlled trial
- Open Access
- Study protocol
Qing Du, Xuan Zhou, Xueqiang Wang, Sun Chen, Xiaoyan Yang, Nan Chen, Juping Liang, Weiwei Deng, Kun Sun
PRomotion Of Physical activity through structured Education with differing Levels of ongoing Support for people at high risk of type 2 diabetes (PROPELS): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Tom Yates, Simon Griffin, Danielle H Bodicoat, Gwen Brierly, Helen Dallosso, Melanie J Davies, Helen Eborall, Charlotte Edwardson, Mike Gillett, Laura Gray, Wendy Hardeman, Sian Hill, Katie Morton, Stephen Sutton, Jacqui Troughton, Kamlesh Khunti
A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Antoinette Schoenthaler, Franzenith De La Calle, Miguel Barrios-Barrios, Aury Garcia, Maria Pitaro, Audrey Lum, Milagros Rosal
Effect of non-surgical periodontal treatment on glycemic control of patients with diabetes: a meta-analysis of randomized controlled trials
- Open Access
- Review
Quan Li, Sha Hao, Jie Fang, Jing Xie, Xiang-Hui Kong, Jian-Xin Yang
Effectiveness of internet-supported cognitive behavioral and chronobiological interventions and effect moderation by insomnia subtype: study protocol of a randomized controlled trial
- Open Access
- Study protocol
Kim Dekker, Jeroen S. Benjamins, Annemieke Van Straten, Winni F. Hofman, Eus J. W. Van Someren
Adding smartphone-based cognitive-behavior therapy to pharmacotherapy for major depression (FLATT project): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Norio Watanabe, Masaru Horikoshi, Mitsuhiko Yamada, Shinji Shimodera, Tatsuo Akechi, Kazuhira Miki, Masatoshi Inagaki, Naohiro Yonemoto, Hissei Imai, Aran Tajika, Yusuke Ogawa, Nozomi Takeshima, Yu Hayasaka, Toshi A. Furukawa
Chinese herbal medicine granules (PTQX) for children with moderate to severe atopic eczema: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Sherman X. Gu, Anthony L. Zhang, Meaghan E. Coyle, Xiumei Mo, George B. Lenon, Noel E. Cranswick, DaCan Chen, Charlie C. Xue
SMS text pre-notification and delivery of reminder e-mails to increase response rates to postal questionnaires in the SUSPEND trial: a factorial design, randomised controlled trial
- Open Access
- Research
Kathryn Starr, Gladys McPherson, Mark Forrest, Seonaidh C. Cotton
Virtual colonoscopy, optical colonoscopy, or fecal occult blood testing for colorectal cancer screening: results of a pilot randomized controlled trial
- Open Access
- Research
John J. You, Yudong Liu, John Kirby, Parag Vora, Paul Moayyedi
Solar-powered oxygen delivery: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Saleh Nyende, Andrea Conroy, Robert Opika Opoka, Sophie Namasopo, Kevin C. Kain, Arthur Mpimbaza, Ravi Bhargava, Michael Hawkes
Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model
- Open Access
- Research
Marina Koniotou, Bridie Angela Evans, Robin Chatters, Rachael Fothergill, Christopher Garnsworthy, Sarah Gaze, Mary Halter, Suzanne Mason, Julie Peconi, Alison Porter, A. Niroshan Siriwardena, Alun Toghill, Helen Snooks
Determination of the efficacy of EVICEL™ on blood loss in orthopaedic surgery after total knee replacement: study protocol for a randomised controlled trial
- Open Access
- Study protocol
S. Budde, Y. Noll, V. Zieglschmid, C. Schroeder, A. Koch, H. Windhagen
Maternal vitamin D supplementation during pregnancy and lactation to promote infant growth in Dhaka, Bangladesh (MDIG trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Daniel E. Roth, Alison D. Gernand, Shaun K. Morris, Brendon Pezzack, M. Munirul Islam, Michelle C. Dimitris, Shaila S. Shanta, Stanley H. Zlotkin, Andrew R. Willan, Tahmeed Ahmed, Prakesh S. Shah, Kellie E. Murphy, Rosanna Weksberg, Sanaa Choufani, Rashed Shah, Abdullah Al Mahmud
Effectiveness of a web-based education program to improve vaccine storage conditions in primary care (Keep Cool): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Anika Thielmann, Anja Viehmann, Birgitta M. Weltermann
Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension
- Open Access
- Update
Anna M. Sawka, Sharon Straus, Gary Rodin, Kevin E. Thorpe, Shereen Ezzat, Amiram Gafni, David P. Goldstein
An internal pilot study for a randomized trial aimed at evaluating the effectiveness of iron interventions in children with non-anemic iron deficiency: the OptEC trial
- Open Access
- Update
Kawsari Abdullah, Kevin E. Thorpe, Eva Mamak, Jonathon L. Maguire, Catherine S. Birken, Darcy Fehlings, Anthony J. Hanley, Colin Macarthur, Stanley H. Zlotkin, Patricia C. Parkin
Choice of Moisturiser for Eczema Treatment (COMET): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Matthew J Ridd, Niamh M Redmond, Sandra Hollinghurst, Nicola Ball, Lindsay Shaw, Richard Guy, Victoria Wilson, Chris Metcalfe, Sarah Purdy
Does treatment of subsyndromal depression improve depression-related and diabetes-related outcomes? A randomised controlled comparison of psychoeducation, physical exercise and enhanced treatment as usual
- Open Access
- Research
Mirjana Pibernik-Okanović, Norbert Hermanns, Dea Ajduković, Jadranka Kos, Manja Prašek, Mario Šekerija, Marijana Vučić Lovrenčić
Similarities and differences between patients included and excluded from a randomized clinical trial of vitamin d supplementation for improving glucose tolerance in prediabetes: interpreting broader applicability
- Open Access
- Research
Yuval Eisenberg, Hiba Mohiuddin, Karthik Cherukupally, Hassan Zaidi, Subhash Kukreja, Elena Barengolts
Podoconiosis treatment in northern Ethiopia (GoLBet): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Henok Negussie, Meseret Molla Kassahun, Greg Fegan, Patricia Njuguna, Fikre Enquselassie, Andy McKay, Melanie Newport, Trudie Lang, Gail Davey
Lamotrigine versus inert placebo in the treatment of borderline personality disorder: study protocol for a randomized controlled trial and economic evaluation
- Open Access
- Study protocol
Mike J. Crawford, Rahil Sanatinia, Barbara Barrett, Sarah Byford, Gillian Cunningham, Kavi Gakhal, Geof Lawrence-Smith, Verity Leeson, Fenella Lemonsky, Georgia Lykomitrou, Alan Montgomery, Richard Morriss, Carol Paton, Wei Tan, Peter Tyrer, Joseph G. Reilly
Improving recruitment to a study of telehealth management for long-term conditions in primary care: two embedded, randomised controlled trials of optimised patient information materials
- Open Access
- Research
Mei-See Man, Jo Rick, Peter Bower
Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation—effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial
- Open Access
- Study protocol
Helene Korvenius Nedergaard, Hanne Irene Jensen, Jørgen T. Lauridsen, Gisela Sjøgaard, Palle Toft
Comprehensive technology-assisted training and supervision program to enhance depression management in primary care in Santiago, Chile: study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Graciela Rojas, Pablo Martínez, Paul A. Vöhringer, Vania Martínez, Ariel Castro-Lara, Rosemarie Fritsch
Erratum to: PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial
- Open Access
- Erratum
Toby Richards, Ben Clevenger, Jane Keidan, Tim Collier, Andrew A. Klein, Stefan D. Anker, John D. Kelly
Impairment reduction in older dizzy people in primary care: study protocol for a cluster randomised controlled trial
- Open Access
- Study protocol
Hanneke Stam, Johannes C. van der Wouden, Henriëtte E. van der Horst, Otto R. Maarsingh
Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multicenter, nonblinded, randomized controlled trial
- Open Access
- Research
Jung-Eun Kim, Byung-Kwan Seo, Jin-Bong Choi, Hyeong-Jun Kim, Tae-Hun Kim, Min-Hee Lee, Kyung-Won Kang, Joo-Hee Kim, Kyung-Min Shin, Seunghoon Lee, So-Young Jung, Ae-Ran Kim, Mi-Suk Shin, Hee-Jung Jung, Hyo-Ju Park, Sung-Phil Kim, Yong-Hyeon Baek, Kwon-Eui Hong, Sun-Mi Choi
BASIC study: is intravaginal boric acid non-inferior to metronidazole in symptomatic bacterial vaginosis? Study protocol for a randomized controlled trial
- Open Access
- Study protocol
Melinda Zeron Mullins, Konia M. Trouton
Emergence times and airway reactions in general laryngeal mask airway anesthesia: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Ana Stevanovic, Rolf Rossaint, András P. Keszei, Harald Fritz, Gebhard Fröba, Friedrich Pühringer, Mark Coburn
Cost-effectiveness of 40-hour versus 100-hour vocational rehabilitation on work participation for workers on sick leave due to subacute or chronic musculoskeletal pain: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Timo T. Beemster, Judith M. van Velzen, Coen A.M. van Bennekom, Monique H.W. Frings-Dresen, Michiel F. Reneman
‘Cloud computing’ and clinical trials: report from an ECRIN workshop
- Open Access
- Commentary
Christian Ohmann, Steve Canham, Edgar Danielyan, Steve Robertshaw, Yannick Legré, Luca Clivio, Jacques Demotes
Short-term intensive psychodynamic group therapy versus cognitive-behavioral group therapy in day treatment of anxiety disorders and comorbid depressive or personality disorders: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Hubert Suszek, Paweł Holas, Tomasz Wyrzykowski, Steinar Lorentzen, Andrzej Kokoszka
The effectiveness and safety of plum-blossom needle therapy for Tourette syndrome: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jinna Yu, Yongming Ye, Shanshan Li, Jun Liu, Yanbing Zhai, Min Zhang, Zhishun Liu
Prehospital use of plasma in traumatic hemorrhage (The PUPTH Trial): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Penny S. Reynolds, Mary Jane Michael, Emily D. Cochran, Jacob A. Wegelin, Bruce D. Spiess
Negative pressure wound therapy use to decrease surgical nosocomial events in colorectal resections (NEPTUNE): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Sami A. Chadi, Kelly N. Vogt, Sarah Knowles, Patrick B. Murphy, Julie Ann Van Koughnett, Muriel Brackstone, Michael C. Ott
Telecoaching plus a portion control plate for weight care management: a randomized trial
- Open Access
- Research
Jill M. Huber, Joshua S. Shapiro, Mark L. Wieland, Ivana T. Croghan, Kristen S. Vickers Douglas, Darrell R. Schroeder, Julie C. Hathaway, Jon O. Ebbert
Clinical evaluation of short 6-mm implants alone, short 8-mm implants combined with osteotome sinus floor elevation and standard 10-mm implants combined with osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jun-Yu Shi, Ying-Xin Gu, Shi-Chong Qiao, Long-Fei Zhuang, Xiao-Meng Zhang, Hong-Chang Lai
The implausibility of ‘usual care’ in an open system: sedation and weaning practices in Paediatric Intensive Care Units (PICUs) in the United Kingdom (UK)
- Open Access
- Methodology
Bronagh Blackwood, Lyvonne Tume
Does oral sodium bicarbonate therapy improve function and quality of life in older patients with chronic kidney disease and low-grade acidosis (the BiCARB trial)? Study protocol for a randomized controlled trial
- Open Access
- Study protocol
Miles D. Witham, Margaret M. Band, Roberta C. Littleford, Alison Avenell, Roy L. Soiza, Marion E. T. McMurdo, Deepa Sumukadas, Simon A. Ogston, Edmund J. Lamb, Geeta Hampson, Paul McNamee
Effects of acupuncture on serum metabolic parameters in premenopausal obese women: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Koh-Woon Kim, Hye Hyun Yoo, Jae-Heung Cho, Yo-Chan Yang, Je-In Kim, Song-Yi Kim, Ji-Yeun Park, Hi-Joon Park, Mi-Yeon Song
The link between obesity and vitamin D in bariatric patients with omega-loop gastric bypass surgery - a vitamin D supplementation trial to compare the efficacy of postoperative cholecalciferol loading (LOAD): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Maria Luger, Renate Kruschitz, Rodrig Marculescu, Helmuth Haslacher, Friedrich Hoppichler, Enikö Kallay, Christian Kienbacher, Carmen Klammer, Melanie Kral, Felix Langer, Eva Luger, Gerhard Prager, Michael Trauner, Stefan Traussnigg, Tanja Würger, Karin Schindler, Bernhard Ludvik
Virtual restorative environment therapy as an adjunct to pain control during burn dressing changes: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Charlotte Small, Robert Stone, Jane Pilsbury, Michael Bowden, Julian Bion
‘On Your Feet to Earn Your Seat’: update to randomised controlled trial protocol
- Open Access
- Update
Benjamin Gardner, Lee Smith, Daniel Aggio, Steve Iliffe, Kenneth R. Fox, Barbara J. Jefferis, Mark Hamer
The effect of on-demand vs deep neuromuscular relaxation on rating of surgical and anaesthesiologic conditions in patients undergoing thoracolaparoscopic esophagectomy (DEPTH trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Denise P. Veelo, Suzanne S. Gisbertz, Rebekka A. Hannivoort, Susan van Dieren, Bart F. Geerts, Mark I. van Berge Henegouwen, Markus W. Hollmann
Metformin and sitAgliptin in patients with impAired glucose tolerance and a recent TIA or minor ischemic Stroke (MAAS): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Elizabeth Osei, Susanne Fonville, Adrienne A. M. Zandbergen, Paul J. A. M. Brouwers, Laus J. M. M. Mulder, Hester F. Lingsma, Diederik W. J. Dippel, Peter J. Koudstaal, Heleen M. den Hertog
Youth Early-intervention Study (YES) – group interventions targeting social participation and physical well-being as an adjunct to treatment as usual: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Lillian Jean Gehue, Elizabeth Scott, Daniel Francis Hermens, Jan Scott, Ian Hickie
Erratum to: Isolated hepatic perfusion as a treatment for uveal melanoma liver metastases (the SCANDIUM trial): study protocol for a randomized controlled trial
- Open Access
- Erratum
Roger Olofsson Bagge, Lars Ny, Charlotta All-Ericsson, Malin Sternby Eilard, Magnus Rizell, Christian Cahlin, Ulrika Stierner, Ulf Lönn, Johan Hansson, Ingrid Ljuslinder, Lotta Lundgren, Gustav Ullenhag, Jens Folke Kiilgaard, Jonas Nilsson, Per Lindnér
Vitamin D supplementation for the prevention of type 2 diabetes in overweight adults: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Barbora de Courten, Aya Mousa, Negar Naderpoor, Helena Teede, Maximilian P J de Courten, Robert Scragg
Upstream therapeutic strategies of Valsartan and Fluvastatin on Hypertensive patients with non-permanent Atrial Fibrillation (VF-HT-AF): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Wen-Wei Qi, Tong Liu, Gang Xu, Li-Feng Li, Ying-Zi Liang, Lan Ye, Guang-Ping Li
The Health Of Patients’ Eyes (HOPE) Glaucoma study. The effectiveness of a ‘glaucoma personal record’ for newly diagnosed glaucoma patients: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Marina Forbes, Helen Fairlamb, Leon Jonker
Erratum to: KCTU randomisation and IMP management system
- Open Access
- Erratum
Caroline Murphy, Joanna Kelly, John Hodsoll, Evangelos Georgiou, Lloyd Morgan, Christopher Rowson, Victoria Cole, Fatima Jichi, Andrew Pickles
The effects of a protein enriched diet with lean red meat combined with a multi-modal exercise program on muscle and cognitive health and function in older adults: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Robin M. Daly, Jenny Gianoudis, Melissa Prosser, Dawson Kidgell, Kathryn A. Ellis, Stella O’Connell, Caryl A. Nowson
Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial
- Open Access
- Study protocol
John Young, Francine Cheater, Michelle Collinson, Marie Fletcher, Anne Forster, Mary Godfrey, John Green, Shamaila Anwar, Suzanne Hartley, Claire Hulme, Sharon K Inouye, David Meads, Gillian Santorelli, Najma Siddiqi, Jane Smith, Elizabeth Teale, Amanda J Farrin
Reporting quality of abstracts in phase III clinical trials of systemic therapy in metastatic solid malignancies
- Open Access
- Research
Shanthi Sivendran, Kristina Newport, Michael Horst, Adam Albert, Matthew D. Galsky
Supported self-management for adults with type 2 diabetes and a learning disability (OK-Diabetes): study protocol for a randomised controlled feasibility trial
- Open Access
- Study protocol
Rebecca E. A. Walwyn, Amy M. Russell, Louise D. Bryant, Amanda J. Farrin, Alexandra M. Wright-Hughes, Elizabeth H. Graham, Claire Hulme, John L. O’Dwyer, Gary J. Latchford, Alison J. Stansfield, Dinesh Nagi, Ramzi A. Ajjan, Allan O. House
First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure – CardioBBEAT
- Open Access
- Methodology
Reiner Hofmann, Heinz Völler, Klaus Nagels, Dominik Bindl, Eik Vettorazzi, Ronny Dittmar, Walter Wohlgemuth, Till Neumann, Stefan Störk, Oliver Bruder, Karl Wegscheider, Eckhard Nagel, Eckart Fleck
Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial
- Open Access
- Study protocol
Morten Hvenegaard, Ed R. Watkins, Stig Poulsen, Nicole K. Rosenberg, Matthias Gondan, Ben Grafton, Stephen F. Austin, Henriette Howard, Stine B. Moeller
Comparison of the effectiveness of low pressure pneumoperitoneum with profound muscle relaxation during laparoscopic donor nephrectomy to optimize the quality of recovery during the early post-operative phase: study protocol for a randomized controlled clinical trial
- Open Access
- Study protocol
Denise M. D. Özdemir-van Brunschot, Gert J. Scheffer, Albert Dahan, Janneke E. E. A. Mulder, Simone A. A. Willems, Luuk B. Hilbrands, Frank C. H. d’Ancona, Rogier A. R. T. Donders, Kees J. H. M. van Laarhoven, Michiel C. Warlé
Effects of a pulmonary rehabilitation program on physical capacity, peripheral muscle function and inflammatory markers in asthmatic children and adolescents: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Mariana Mazzuca Reimberg, Rejane Agnelo Silva Castro, Jessyca Pachi Rodrigues Selman, Aline Santos Meneses, Fabiano Politti, Márcia Carvalho Mallozi, Gustavo Falbo Wandalsen, Dirceu Solé, Kátia De Angelis, Simone Dal Corso, Fernanda Cordoba Lanza
Assessing the effectiveness of household-level focal mass drug administration and community-wide mass drug administration for reducing malaria parasite infection prevalence and incidence in Southern Province, Zambia: study protocol for a community randomized controlled trial
- Open Access
- Study protocol
Thomas P. Eisele, Kafula Silumbe, Timothy Finn, Victor Chalwe, Mukalwa Kamuliwo, Busiku Hamainza, Hawela Moonga, Adam Bennett, Josh Yukich, Joseph Keating, Richard W. Steketee, John M. Miller
A cluster randomised controlled trial and process evaluation of a training programme for mental health professionals to enhance user involvement in care planning in service users with severe mental health issues (EQUIP): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Peter Bower, Chris Roberts, Neil O’Leary, Patrick Callaghan, Penny Bee, Claire Fraser, Chris Gibbons, Nicola Olleveant, Anne Rogers, Linda Davies, Richard Drake, Caroline Sanders, Oonagh Meade, Andrew Grundy, Lauren Walker, Lindsey Cree, Kathryn Berzins, Helen Brooks, Susan Beatty, Patrick Cahoon, Anita Rolfe, Karina Lovell
The effects of an Audio Visual Assisted Therapy Aid for Refractory auditory hallucinations (AVATAR therapy): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Tom K.J Craig, Mar Rus-Calafell, Thomas Ward, Miriam Fornells-Ambrojo, Paul McCrone, Richard Emsley, Philippa Garety
Five questions to consider before conducting a stepped wedge trial
- Open Access
- Commentary
James R Hargreaves, Andrew J Copas, Emma Beard, David Osrin, James J Lewis, Calum Davey, Jennifer A Thompson, Gianluca Baio, Katherine L Fielding, Audrey Prost
Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies
- Open Access
- Research
Audrey Prost, Ariella Binik, Ibrahim Abubakar, Anjana Roy, Manuela De Allegri, Christelle Mouchoux, Tobias Dreischulte, Helen Ayles, James J. Lewis, David Osrin
Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches
- Open Access
- Methodology
Andrew J. Copas, James J. Lewis, Jennifer A. Thompson, Calum Davey, Gianluca Baio, James R. Hargreaves
Stepped wedge randomised controlled trials: systematic review of studies published between 2010 and 2014
- Open Access
- Research
Emma Beard, James J. Lewis, Andrew Copas, Calum Davey, David Osrin, Gianluca Baio, Jennifer A. Thompson, Katherine L. Fielding, Rumana Z. Omar, Sam Ononge, James Hargreaves, Audrey Prost
Sample size calculation for a stepped wedge trial
- Open Access
- Research
Gianluca Baio, Andrew Copas, Gareth Ambler, James Hargreaves, Emma Beard, Rumana Z Omar
Can an antimicrobial stewardship program reduce length of stay of immune-competent adult patients admitted to hospital with diagnosis of community-acquired pneumonia? Study protocol for pragmatic controlled non-randomized clinical study
- Open Access
- Study protocol
Giulio DiDiodato, Leslie McArthur, Joseph Beyene, Marek Smieja, Lehana Thabane
Effectiveness of prepregnancy care for women with pregestational diabetes mellitus: protocol for a systematic review of the literature and identification of a core outcomes set using a Delphi survey
- Open Access
- Study protocol
Aoife M. Egan, Valerie Smith, Declan Devane, Fidelma P. Dunne
Continuous wound infusion of local anesthetic and steroid after major abdominal surgery: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Dario Bugada, Manuela De Gregori, Christian Compagnone, Carolina Muscoli, Ferdinando Raimondi, Silvia Bettinelli, Maria Antonietta Avanzini, Lorenzo Cobianchi, Andrea Peloso, Marco Baciarello, Concetta Dagostino, Luigino A. Giancotti, Sara Ilari, Filomena Lauro, Stefania Grimaldi, Ennio Tasciotti, Massimo Fini, Gloria M R Saccani Jotti, Tiziana Meschi, Guido Fanelli, Massimo Allegri
Analysis and reporting of stepped wedge randomised controlled trials: synthesis and critical appraisal of published studies, 2010 to 2014
- Open Access
- Research
Calum Davey, James Hargreaves, Jennifer A Thompson, Andrew J Copas, Emma Beard, James J Lewis, Katherine L Fielding
How important is randomisation in a stepped wedge trial?
- Open Access
- Commentary
James R Hargreaves, Audrey Prost, Katherine L. Fielding, Andrew J. Copas
Reduced patient restrictions following total hip arthroplasty: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Anil Peters, Miranda Tijink, Anne Veldhuijzen, Rianne Huis in ‘t Veld
Health allowance for improving the nutritional status and development of 3–5-year-old left-behind children in poor rural areas of China: study protocol for a cluster randomised trial
- Open Access
- Study protocol
Qian Lin, Peymané Adab, Karla Hemming, Lina Yang, Hong Qin, Mingzhi Li, Jing Deng, Jingcheng Shi, Jihua Chen
Transverse occiput position: Using manual Rotation to aid Normal birth and improve delivery OUTcomes (TURN-OUT): A study protocol for a randomised controlled trial
- Open Access
- Study protocol
Bradley de Vries, Hala Phipps, Sabrina Kuah, John Pardey, Joanne Ludlow, Andrew Bisits, Felicity Park, David Kowalski, Jon A. Hyett
Operative hysteroscopy versus vacuum aspiration for incomplete spontaneous abortion (HY-PER): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Cyrille Huchon, Martin Koskas, Aubert Agostini, Cherif Akladios, Souhail Alouini, Estelle Bauville, Nicolas Bourdel, Hervé Fernandez, Xavier Fritel, Olivier Graesslin, Guillaume Legendre, Jean-Philippe Lucot, Isabelle Matheron, Pierre Panel, Cyril Raiffort, Arnaud Fauconnier
Standardised outcomes in nephrology – Haemodialysis (SONG-HD): study protocol for establishing a core outcome set in haemodialysis
- Open Access
- Study protocol
Allison Tong, Braden Manns, Brenda Hemmelgarn, David C. Wheeler, Peter Tugwell, Wolfgang C. Winkelmayer, Wim van Biesen, Sally Crowe, Peter G. Kerr, Kevan R. Polkinghorne, Kirsten Howard, Carol Pollock, Carmel M. Hawley, David W. Johnson, Stephen P. McDonald, Martin P. Gallagher, Rachel Urquhart-Secord, Jonathan C. Craig
Long-term safety and efficacy of antithymocyte globulin induction: use of integrated national registry data to achieve ten-year follow-up of 10-10 Study participants
- Open Access
- Research
Krista L. Lentine, Mark A. Schnitzler, Huiling Xiao, Daniel C. Brennan
Multimodal treatment of perianal fistulas in Crohn’s disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial
- Open Access
- Study protocol
E. Joline de Groof, Christianne J. Buskens, Cyriel Y. Ponsioen, Marcel G. W. Dijkgraaf, Geert R. A. M. D’Haens, Nidhi Srivastava, Gijs J. D. van Acker, Jeroen M. Jansen, Michael F. Gerhards, Gerard Dijkstra, Johan F. M. Lange, Ben J. M. Witteman, Philip M. Kruyt, Apollo Pronk, Sebastiaan A. C. van Tuyl, Alexander Bodelier, Rogier M. P. H. Crolla, Rachel L. West, Wietske W. Vrijland, Esther C. J. Consten, Menno A. Brink, Jurriaan B. Tuynman, Nanne K. H. de Boer, Stephanie O. Breukink, Marieke J. Pierik, Bas Oldenburg, Andrea E. van der Meulen, Bert A. Bonsing, Antonino Spinelli, Silvio Danese, Matteo Sacchi, Janindra Warusavitarne, Ailsa Hart, Nuha A. Yassin, Rory P. Kennelly, Garret J. Cullen, Desmond C. Winter, A. Barney Hawthorne, Jared Torkington, Willem A. Bemelman
Combining behavioural activation with physical activity promotion for adults with depression: findings of a parallel-group pilot randomised controlled trial (BAcPAc)
- Open Access
- Research
Claire Pentecost, Paul Farrand, Colin J. Greaves, Rod S. Taylor, Fiona C. Warren, Melvyn Hillsdon, Colin Green, Jo R. Welsman, Kat Rayson, Philip H. Evans, Adrian H. Taylor
Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study
- Open Access
- Study protocol
Bronagh Blackwood, Suzanne Ringrow, Mike Clarke, John Marshall, Louise Rose, Paula Williamson, Danny McAuley
The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials
- Open Access
- Study protocol
Gillian Mead, Maree L. Hackett, Erik Lundström, Veronica Murray, Graeme J. Hankey, Martin Dennis
Evaluation of dose reduction versus standard dosing for maintenance of remission in patients with spondyloarthritis and clinical remission with anti-TNF (REDES-TNF): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Caridad Pontes, Jordi Gratacós, Ferran Torres, Cristina Avendaño, Jesús Sanz, Antoni Vallano, Xavier Juanola, Eugenio de Miguel, Raimon Sanmartí, Gonzalo Calvo
Transcutaneous auricular vagus nerve stimulation for pediatric epilepsy: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Wei He, Xiao-Yu Wang, Li Zhou, Zhi-Mei Li, Xiang-Hong Jing, Zhong-Li Lv, Yu-Feng Zhao, Hong Shi, Ling Hu, Yang-Shuai Su, Bing Zhu
Engaging teenagers in improving their health behaviours and increasing their interest in science (Evaluation of LifeLab Southampton): study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Kathryn Woods-Townsend, Lisa Bagust, Mary Barker, Andri Christodoulou, Hannah Davey, Keith Godfrey, Marcus Grace, Janice Griffiths, Mark Hanson, Hazel Inskip
COS-STAR: a reporting guideline for studies developing core outcome sets (protocol)
- Open Access
- Study protocol
Jamie J. Kirkham, Sarah Gorst, Douglas G. Altman, Jane Blazeby, Mike Clarke, Declan Devane, Elizabeth Gargon, Paula R. Williamson
Topical clobetasol for the treatment of toxic epidermal necrolysis: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Reason Wilken, Chin Shang Li, Victoria R. Sharon, Kyoungmi Kim, Falin B. Patel, Forum Patel, Emanual Maverakis
Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design
- Open Access
- Methodology
Nonsikelelo Mathe, Steven T. Johnson, Lisa A Wozniak, Sumit R. Majumdar, Jeffrey A. Johnson
Prevention of Morbidity in sickle cell disease - qualitative outcomes, pain and quality of life in a randomised cross-over pilot trial of overnight supplementary oxygen and auto-adjusting continuous positive airways pressure (POMS2a): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Jo Howard, Baba Inusa, Christina Liossi, Eufemia Jacob, Patrick B Murphy, Nicholas Hart, Johanna Gavlak, Sati Sahota, Maria Chorozoglou, Carol Nwosu, Maureen Gwam, Atul Gupta, David C Rees, Swee Lay Thein, Isabel C Reading, Fenella J Kirkham, Man Yeung Edith Cheng
Remote ischaemic preconditioning versus sham procedure for abdominal aortic aneurysm repair: an external feasibility randomized controlled trial
- Open Access
- Research
Ronelle Mouton, Jon Pollock, Jasmeet Soar, David C. Mitchell, Chris A. Rogers
Effects of electroacupuncture therapy for Bell’s palsy from acute stage: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Zhi-dan Liu, Jiang-bo He, Si-si Guo, Zhi-xin Yang, Jun Shen, Xiao-yan Li, Wei Liang, Wei-dong Shen
Mindfulness-based cognitive therapy for inflammatory bowel disease patients: findings from an exploratory pilot randomised controlled trial
- Open Access
- Research
Mariyana Schoultz, Iain Atherton, Angus Watson
Effect of a patient-centered drug review on polypharmacy in primary care patients: study protocol for a cluster-randomized controlled trial
- Open Access
- Study protocol
Susann Hasler, Oliver Senn, Thomas Rosemann, Stefan Neuner-Jehle
Multidimensional individualised Physical ACTivity (Mi-PACT) – a technology-enabled intervention to promote physical activity in primary care: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Oliver J. Peacock, Max J. Western, Alan M. Batterham, Afroditi Stathi, Martyn Standage, Alan Tapp, Paul Bennett, Dylan Thompson
The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial
- Open Access
- Study protocol
Jennifer Straatman, Miguel A. Cuesta, W. H. (Hermien) Schreurs, Boudewijn J. Dwars, Huib A. Cense, Herman Rijna, D. J. A. (Eric) Sonneveld, Frank C. den Boer, Elly S. M. de Lange- de Klerk, Donald L. van der Peet
Early rehabilitation using a passive cycle ergometer on muscle morphology in mechanically ventilated critically ill patients in the Intensive Care Unit (MoVe-ICU study): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Laura Jurema dos Santos, Fernando de Aguiar Lemos, Tanara Bianchi, Amanda Sachetti, Ana Maria Dall’ Acqua, Wagner da Silva Naue, Alexandre Simões Dias, Silvia Regina Rios Vieira
Comparison of 6 % hydroxyethyl starch and 5 % albumin for volume replacement therapy in patients undergoing cystectomy (CHART): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Tobias Kammerer, Florian Klug, Michaela Schwarz, Sebastian Hilferink, Bernhard Zwissler, Vera von Dossow, Alexander Karl, Hans-Helge Müller, Markus Rehm
Integrating smoking cessation and alcohol use treatment in homeless populations: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Olamide Ojo-Fati, Florence John, Janet Thomas, Anne M. Joseph, Nancy C. Raymond, Ned L. Cooney, Rebekah Pratt, Charles R. Rogers, Susan A. Everson-Rose, Xianghua Luo, Kolawole S. Okuyemi
Reducing the confusion and controversies around pragmatic trials: using the Cardiovascular Health Awareness Program (CHAP) trial as an illustrative example
- Open Access
- Commentary
Lehana Thabane, Janusz Kaczorowski, Lisa Dolovich, Larry W. Chambers, Lawrence Mbuagbaw
Peer-led healthy lifestyle program in supportive housing: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Leopoldo J. Cabassa, Ana Stefancic, Kathleen O’Hara, Nabila El-Bassel, Roberto Lewis-Fernández, José A. Luchsinger, Lauren Gates, Richard Younge, Melanie Wall, Lara Weinstein, Lawrence A. Palinkas
Preventive nebulization of mucolytic agents and bronchodilating drugs in invasively ventilated intensive care unit patients (NEBULAE): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Sophia M. van der Hoeven, Jan M. Binnekade, Corianne A. J. M. de Borgie, Frank H. Bosch, Henrik Endeman, Janneke Horn, Nicole P. Juffermans, Nardo J. M. van der Meer, Maruschka P. Merkus, Hazra S. Moeniralam, Bart van Silfhout, Mathilde Slabbekoorn, Willemke Stilma, Jan Willem Wijnhoven, Marcus J. Schultz, Frederique Paulus
A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Eleanor F. Harrison, Rachel H. Haines, Fiona Cowdell, Tracey H. Sach, Taraneh Dean, Ian Pollock, Nigel P. Burrows, Hannah Buckley, Jonathan Batchelor, Hywel C. Williams, Sandra Lawton, Sara J. Brown, Lucy E. Bradshaw, Amina Ahmed, Alan A. Montgomery, Eleanor J. Mitchell, Kim S. Thomas
Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Chris Lo, Sarah Hales, Anne Rydall, Tania Panday, Aubrey Chiu, Carmine Malfitano, Judy Jung, Madeline Li, Rinat Nissim, Camilla Zimmermann, Gary Rodin
Interventions in randomised controlled trials in surgery: issues to consider during trial design
- Open Access
- Review
Natalie S. Blencowe, Julia M. Brown, Jonathan A. Cook, Chris Metcalfe, Dion G. Morton, Jon Nicholl, Linda D. Sharples, Shaun Treweek, Jane M. Blazeby
Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation (APACHE-AF): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Koen M. van Nieuwenhuizen, H. Bart van der Worp, Ale Algra, L. Jaap Kappelle, Gabriel J. E. Rinkel, Isabelle C. van Gelder, Roger E. G. Schutgens, Catharina J. M. Klijn
Randomised trials in context: practical problems and social aspects of evidence-based medicine and policy
- Open Access
- Review
Warren Pearce, Sujatha Raman, Andrew Turner
Study protocol for a randomized controlled trial: tongue strengthening exercises in head and neck cancer patients, does exercise load matter?
- Open Access
- Study protocol
Gwen Van Nuffelen, Leen Van den Steen, Olivier Vanderveken, Pol Specenier, Carl Van Laer, Diane Van Rompaey, Cindy Guns, Steven Mariën, Marc Peeters, Paul Van de Heyning, Jan Vanderwegen, Marc De Bodt
Wrist-ankle acupuncture (WAA) for precompetition nervous syndrome: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Shi Shu, Mei Zhan, Yan-li You, Xiao-lu Qian, Chun-ming Li, Cheng-lin Zhou, Shuang Zhou
Outcomes in Trials for Management of Caries Lesions (OuTMaC): protocol
- Open Access
- Study protocol
Falk Schwendicke, Thomas Lamont, Nicola Innes
Remote ischemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI): study protocol for a randomized controlled trial
- Open Access
- Study protocol
António Gaspar, Miguel Álvares Pereira, Pedro Azevedo, André Lourenço, Jorge Marques, Adelino Leite-Moreira
Management of adolescents with very poorly controlled type 1 diabetes by nurses: a parallel group randomized controlled trial
- Open Access
- Research
Behrouz Kassai, Muriel Rabilloud, Delphine Bernoux, Catherine Michal, Benjamin Riche, Tiphanie Ginhoux, Valérie Laudy, Daniel Terral, Catherine Didier-Wright, Veronique Maire, Catherine Dumont, Gilles Cottancin, Muriel Plasse, Guy-Patrick Jeannoel, Jamil Khoury, Claire Bony, Michel Lièvre, Jocelyne Drai, Marc Nicolino
A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: the INVESTIGATE-I study
- Open Access
- Research
Paul Hilton, Natalie Armstrong, Catherine Brennand, Denise Howel, Jing Shen, Andrew Bryant, Douglas G. Tincello, Malcolm G. Lucas, Brian S. Buckley, Christopher R. Chapple, Tara Homer, Luke Vale, Elaine McColl
The effectiveness of VIPP-V parenting training for parents of young children with a visual or visual-and-intellectual disability: study protocol of a multicenter randomized controlled trial
- Open Access
- Study protocol
Mathilde M. Overbeek, Paula S. Sterkenburg, Sabina Kef, Carlo Schuengel
Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial
- Open Access
- Study protocol
J. Dayre McNally, Katie O’Hearn, Margaret L. Lawson, Gyaandeo Maharajh, Pavel Geier, Hope Weiler, Stephanie Redpath, Lauralyn McIntyre, Dean Fergusson, Kusum Menon
A comparison of CPAP and CPAPFLEX in the treatment of obstructive sleep apnea in World Trade Center responders: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Indu Ayappa, Jag Sunderram, Kathleen Black, Akosua Twumasi, Iris Udasin, Denise Harrison, Jeffrey L. Carson, Shou-En Lu, David M. Rapoport
Using mobile technology to deliver a cognitive behaviour therapy-informed intervention in early psychosis (Actissist): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Sandra Bucci, Christine Barrowclough, John Ainsworth, Rohan Morris, Katherine Berry, Matthew Machin, Richard Emsley, Shon Lewis, Dawn Edge, Iain Buchan, Gillian Haddock
Risk of selection bias in randomised trials
- Open Access
- Research
Brennan C. Kahan, Sunita Rehal, Suzie Cro
Comparing the effectiveness of selective laser trabeculoplasty with topical medication as initial treatment (the Glaucoma Initial Treatment Study): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Ecosse L. Lamoureux, Rachel Mcintosh, Marios Constantinou, Eva K. Fenwick, Jing Xie, Robert Casson, Eric Finkelstein, Ivan Goldberg, Paul Healey, Ravi Thomas, Ghee Soon Ang, Konrad Pesudovs, Jonathan Crowston
Cord pilot trial: update to randomised trial protocol
- Open Access
- Update
Lucy E. Bradshaw, Angela Pushpa-Rajah, Jon Dorling, Eleanor J. Mitchell, Lelia Duley
A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Bastiaan P. Vierhout, Ben R. Saleem, Alewijn Ott, Jan Maarten van Dijl, Ties D. van Andringa de Kempenaer, Maurice E. N. Pierie, Jan T. Bottema, Clark J. Zeebregts
Harmonizing Optimal Strategy for Treatment of coronary artery diseases – comparison of REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients (HOST-REDUCE-POLYTECH-ACS RCT): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Joo Myung Lee, Ji-Hyun Jung, Kyung Woo Park, Eun-Seok Shin, Seok Kyu Oh, Jang-Whan Bae, Jay Young Rhew, Namho Lee, Dong-Bin Kim, Ung Kim, Jung-Kyu Han, Sang Eun Lee, Han-Mo Yang, Hyun-Jae Kang, Bon-Kwon Koo, Sanghyun Kim, Yun Kyeong Cho, Won-Yong Shin, Young-Hyo Lim, Seung-Woon Rha, Seok-Yeon Kim, Sung Yun Lee, Young-Dae Kim, In-Ho Chae, Kwang Soo Cha, Hyo-Soo Kim
Minocycline as an adjunct for treatment-resistant depressive symptoms: study protocol for a pilot randomised controlled trial
- Open Access
- Study protocol
Muhammad I. Husain, Imran B. Chaudhry, Raza R. Rahman, Munir M. Hamirani, Inti Qurashi, Ameer B. Khoso, John FW Deakin, Nusrat Husain, Allan H. Young
Who is eligible for randomized trials? A comparison between the exclusion criteria defined by the ISCHEMIA trial and 3102 real-world patients with stable coronary artery disease undergoing stent implantation in a single cardiology center
- Open Access
- Research
Jarosław Wasilewski, Lech Poloński, Andrzej Lekston, Tadeusz Osadnik, Rafał Reguła, Kamil Bujak, Anna Kurek
Erratum to: Long-term safety and efficacy of antithymocyte globulin induction: use of integrated national registry data to achieve ten-year follow-up of 10–10 Study participants
- Open Access
- Erratum
Krista L. Lentine, Mark A. Schnitzler, Huiling Xiao, Daniel C. Brennan
Engaging rural women in healthy lifestyle programs: insights from a randomized controlled trial
- Open Access
- Research
Samantha L. Kozica, Cheryce L. Harrison, Helena J. Teede, Sze Ng, Lisa J. Moran, Catherine B. Lombard
The effect of massage therapy and/or exercise therapy on subacute or long-lasting neck pain - the Stockholm neck trial (STONE): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Eva Skillgate, Anne-Sylvie Bill, Pierre Côté, Peter Viklund, Anna Peterson, Lena W. Holm
Analgesic effect of cathodal transcranial current stimulation over right dorsolateral prefrontal cortex in subjects with muscular temporomandibular disorders: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Rivail Almeida Brandão Filho, Abrahão Fontes Baptista, Renata de Assis Fonseca Santos Brandão, Francisco Monteiro Meneses, Jeffrey Okeson, Eduardo Pondé de Sena
Face-to-face individual counseling and online group motivational interviewing in improving oral health: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Xiaoli Gao, Edward Chin-Man Lo, Colman McGrath, Samuel Mun-Yin Ho
Recommendations and evidence for reporting items in pediatric clinical trial protocols and reports: two systematic reviews
- Open Access
- Research
April V. P. Clyburne-Sherin, Pravheen Thurairajah, Mufiza Z. Kapadia, Margaret Sampson, Winnie W. Y. Chan, Martin Offringa
Interactive web-based lifestyle intervention and metabolic syndrome: findings from the Red Ruby (a randomized controlled trial)
- Open Access
- Research
Leila Jahangiry, Davoud Shojaeizadeh, Mahdieh Abbasalizad Farhangi, Mehdi Yaseri, Kazem Mohammad, Mahdi Najafi, Ali Montazeri
Comparing half-dose photodynamic therapy with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (the PLACE trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Myrte B. Breukink, Susan M. Downes, Giuseppe Querques, Elon H. C. van Dijk, Anneke I. den Hollander, Rocio Blanco-Garavito, Jan E. E. Keunen, Eric H. Souied, Robert E. MacLaren, Carel B. Hoyng, Sascha Fauser, Camiel J. F. Boon
Ghana randomized air pollution and health study (GRAPHS): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Darby W. Jack, Kwaku Poku Asante, Blair J. Wylie, Steve N. Chillrud, Robin M. Whyatt, Kenneth A. Ae-Ngibise, Ashlinn K. Quinn, Abena Konadu Yawson, Ellen Abrafi Boamah, Oscar Agyei, Mohammed Mujtaba, Seyram Kaali, Patrick Kinney, Seth Owusu-Agyei
The NULevel trial of a scalable, technology-assisted weight loss maintenance intervention for obese adults after clinically significant weight loss: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Elizabeth H. Evans, Vera Araújo-Soares, Ashley Adamson, Alan M. Batterham, Heather Brown, Miglena Campbell, Stephan U. Dombrowski, Alison Guest, Daniel Jackson, Dominika Kwasnicka, Karim Ladha, Elaine McColl, Patrick Olivier, Alexander J. Rothman, Kirby Sainsbury, Alison J. Steel, Ian Nicholas Steen, Luke Vale, Martin White, Peter Wright, Falko F. Sniehotta
High frequency oscillations in the intra-operative ECoG to guide epilepsy surgery (“The HFO Trial”): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Maryse A. van ’t Klooster, Frans S. S. Leijten, Geertjan Huiskamp, Hanneke E. Ronner, Johannes C. Baayen, Peter C. van Rijen, Martinus J. C. Eijkemans, Kees P. J. Braun, Maeike Zijlmans
COMParative Early Treatment Effectiveness between physical therapy and usual care for low back pain (COMPETE): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Daniel Rhon, Julie Fritz
Efficacy of acupuncture for chronic asthma: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Lei-Miao Yin, Yu Wang, Lei Fan, Yu-Dong Xu, Wen-Qian Wang, Yan-Yan Liu, Jun-Tao Feng, Cheng-Ping Hu, Pei-Yu Wang, Tie-Feng Zhang, Su-Ju Shao, Yong-Qing Yang
Implementing Kanyini GAP, a pragmatic randomised controlled trial in Australia: findings from a qualitative study
- Open Access
- Research
Hueiming Liu, Luciana Massi, Anne-Marie Eades, Kirsten Howard, David Peiris, Julie Redfern, Tim Usherwood, Alan Cass, Anushka Patel, Stephen Jan, Tracey-Lea Laba
The effectiveness of the biannual application of silver nitrate solution followed by sodium fluoride varnish in arresting early childhood caries in preschool children: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Chun-Hung Chu, Sherry Shiqian Gao, Samantha KY Li, May CM Wong, Edward CM Lo
Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound (PESAPRO Trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Lourdes Cabrera-García, Sara Cruz-Melguizo, Belén Ruiz-Antorán, Ferrán Torres, Ana Velasco, Cristina Martínez-Payo, Cristina Avendaño-Solá
Recruitment challenges in clinical research including cancer patients and caregivers
- Open Access
- Methodology
Karin Sygna, Safora Johansen, Cornelia M. Ruland
Impact of tracheal cuff shape on microaspiration of gastric contents in intubated critically ill patients: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Emmanuelle Jaillette, Guillaume Brunin, Christophe Girault, Farid Zerimech, Arnaud Chiche, Céline Broucqsault-Dedrie, Cyril Fayolle, Franck Minacori, Isabelle Alves, Stephanie Barrailler, Laurent Robriquet, Fabienne Tamion, Emmanuel Delaporte, Damien Thellier, Claire Delcourte, Alain Duhamel, Saad Nseir
Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials
- Open Access
- Research
Munyaradzi Dimairo, Jonathan Boote, Steven A. Julious, Jonathan P. Nicholl, Susan Todd
Feasibility and effectiveness of the baby friendly community initiative in rural Kenya: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Elizabeth W. Kimani-Murage, Judith Kimiywe, Mark Kabue, Frederick Wekesah, Evelyn Matiri, Nelson Muhia, Milka Wanjohi, Peterrock Muriuki, Betty Samburu, James N. Kanyuira, Sera L. Young, Paula L. Griffiths, Nyovani J. Madise, Stephen T. McGarvey
A systematic review of training programmes for recruiters to randomised controlled trials
- Open Access
- Research
Daisy Townsend, Nicola Mills, Jelena Savović, Jenny L. Donovan
A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents
- Open Access
- Research
Ruth Stow, Natalie Ives, Christina Smith, Caroline Rick, Alison Rushton
Efficacy of a pressure-sensing mattress cover system for reducing interface pressure: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Holly Wong, Jaime Kaufman, Barry Baylis, John M. Conly, David B. Hogan, Henry T. Stelfox, Danielle A. Southern, William A. Ghali, Chester H. Ho
Neurostimulation for cognitive rehabilitation in stroke (NeuroCog): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Suellen Marinho Andrade, Bernardino Fernández-Calvo, Paulo Sérgio Boggio, Eliane Araújo de Oliveira, Lilze Franklim Gomes, José Eudes Gomes Pinheiro Júnior, Rafaela Martins Rodrigues, Natália Leandro de Almeida, Gioconda Marla de Siqueira Moreira, Nelson Torro Alves
A web-based intervention to promote applications for rehabilitation: a study protocol for a randomized controlled trial
- Open Access
- Study protocol
Katja Spanier, Marco Streibelt, Firat Ünalan, Matthias Bethge
A comparison of intervention and conservative treatment for angulated fractures of the distal forearm in children (AFIC): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Miriam Adrian, Daniel Wachtlin, Kai Kronfeld, Dirk Sommerfeldt, Lucas M. Wessel
Enhancing assertive community treatment with cognitive behavioral social skills training for schizophrenia: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Eric Granholm, Jason L. Holden, David Sommerfeld, Christine Rufener, Dimitri Perivoliotis, Kim Mueser, Gregory A. Aarons
Cytokine inhibition in chronic fatigue syndrome patients: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Megan E. Roerink, Hans Knoop, Sebastian J. H. Bredie, Michael Heijnen, Leo A. B. Joosten, Mihai G. Netea, Charles A. Dinarello, Jos W. M. van der Meer
Repetitive Transcranial Magnetic Stimulation (rTMS) for the cognitive rehabilitation of traumatic brain injury (TBI) victims: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Iuri Santana Neville, Cintya Yukie Hayashi, Simone Alves El Hajj, Ana Luiza Costa Zaninotto, Juliana Perez Sabino, Leonardo Moura Sousa Jr, Marcia Mitie Nagumo, André Russowsky Brunoni, Barbara Dal Forno Silva Shieh, Robson Luis Oliveira Amorim, Manoel Jacobsen Teixeira, Wellingson Silva Paiva
Perioperative smoking cessation in vascular surgery: challenges with a randomized controlled trial
- Open Access
- Research
Mette Kehlet, Sabine Heeseman, Hanne Tønnesen, Torben V. Schroeder
Effectiveness of a behavioural intervention to prevent excessive weight gain during infancy (The Baby Milk Trial): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Rajalakshmi Lakshman, Fiona Whittle, Wendy Hardeman, Marc Suhrcke, Ed Wilson, Simon Griffin, Ken K Ong
Supervised exercise training as an adjunctive therapy for venous leg ulcers: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Garry A. Tew, Jonathan Michaels, Helen Crank, Geoff Middleton, Anil Gumber, Markos Klonizakis
Faecal incontinence intervention study (FINS): self-management booklet information with or without nurse support to improve continence in people with inflammatory bowel disease: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Christine Norton, Lesley B. Dibley, Ailsa Hart, Julie Duncan, Anton Emmanuel, Charles H. Knowles, Natasha Stevens, Helen Terry, Azmina Verjee, Sally Kerry, Natalia Hounsome
Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Xiuwen Wu, Jianan Ren, Gefei Wang, Jianzhong Wang, Feng Wang, Yueping Fan, Yuanxin Li, Gang Han, Yanbing Zhou, Xiaofei Song, Bin Quan, Min Yao, Jieshou Li
Physical activity screening to recruit inactive randomized controlled trial participants: how much is too much?
- Open Access
- Letter
Corneel Vandelanotte, Robert Stanton, Amanda L. Rebar, Anetta K. Van Itallie, Cristina M. Caperchione, Mitch J. Duncan, Trevor N. Savage, Richard R. Rosenkranz, Gregory S. Kolt
Evaluating a collaborative smoking cessation intervention in primary care (ENTER): study protocol for a cluster-randomized controlled trial
- Open Access
- Study protocol
Martin Härter, Anna-Lena Bartsch, Nina Egger, Hans-Helmut König, Levente Kriston, Holger Schulz, Michael Tiemann, Anna Levke Brütt, Angela Buchholz
Nortriptyline in knee osteoarthritis (NortIKA Study): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Ben Hudson, Jonathan A. Williman, Lisa K. Stamp, John S. Alchin, Gary J. Hooper, Dee Mangin, Bronwyn F. Thompson, Les Toop
Xenon for the prevention of postoperative delirium in cardiac surgery: study protocol for a randomized controlled clinical trial
- Open Access
- Study protocol
Layth Al Tmimi, Marc Van de Velde, Paul Herijgers, Bart Meyns, Geert Meyfroidt, Koen Milisen, Steffen Fieuws, Mark Coburn, Koen Poesen, Steffen Rex
Early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection (SABATO): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Achim J. Kaasch, Gerd Fätkenheuer, Reinhild Prinz-Langenohl, Ursula Paulus, Martin Hellmich, Verena Weiß, Norma Jung, Siegbert Rieg, Winfried V. Kern, Harald Seifert
Informed shared decision-making supported by decision coaches for women with ductal carcinoma in situ: study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Birte Berger-Höger, Katrin Liethmann, Ingrid Mühlhauser, Burkhard Haastert, Anke Steckelberg
Trial for the Prevention of Depression (TriPoD) in final-year secondary students: study protocol for a cluster randomised controlled trial
- Open Access
- Study protocol
Yael Perry, Alison L. Calear, Andrew Mackinnon, Philip J. Batterham, Julio Licinio, Catherine King, Noel Thomsen, Jan Scott, Tara Donker, Sally Merry, Theresa Fleming, Karolina Stasiak, Aliza Werner-Seidler, Helen Christensen
Physical activity intervention (Movi-Kids) on improving academic achievement and adiposity in preschoolers with or without attention deficit hyperactivity disorder: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Mairena Sánchez-López, María Jesús Pardo-Guijarro, David Gutiérrez-Díaz del Campo, Pedro Silva, Maria Martínez-Andrés, Roberto Gulías-González, Ana Díez-Fernández, Pablo Franquelo-Morales, Vicente Martínez-Vizcaíno
Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jinho Lee, Joon-Shik Shin, Yoon Jae Lee, Me-riong Kim, Yong-jun Ahn, Ki Byung Park, Michael A. Kropf, Byung-Cheul Shin, Myeong Soo Lee, In-Hyuk Ha
Rationale and design of the Adapted Physical Activity in advanced Pancreatic Cancer patients (APACaP) GERCOR (Groupe Coopérateur Multidisciplinaire en Oncologie) trial: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Cindy Neuzillet, Mathieu Vergnault, Franck Bonnetain, Pascal Hammel
Oropharyngeal administration of mother’s colostrum, health outcomes of premature infants: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Nancy A. Rodriguez, Maximo Vento, Erika C. Claud, Chihsiung E. Wang, Michael S. Caplan
Modular Approach to Therapy for Anxiety, Depression, Trauma, or Conduct Problems in outpatient child and adolescent mental health services in New Zealand: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Mathijs F. G. Lucassen, Karolina Stasiak, Sue Crengle, John R. Weisz, Christopher M. A. Frampton, Sarah Kate Bearman, Ana M. Ugueto, Jennifer Herren, Ainsleigh Cribb-Su’a, Monique Faleafa, Denise Kingi-’Ulu’ave, Jik Loy, Rebecca M. Scott, Morgyn Hartdegen, Sally N. Merry
An internal pilot design for prospective cancer screening trials with unknown disease prevalence
- Open Access
- Methodology
John T. Brinton, Brandy M. Ringham, Deborah H. Glueck
Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan
- Open Access
- Update
Naohiro Yonemoto, Shiro Tanaka, Toshi A. Furukawa, Tadashi Kato, Akio Mantani, Yusuke Ogawa, Aran Tajika, Nozomi Takeshima, Yu Hayasaka, Kiyomi Shinohara, Kazuhira Miki, Masatoshi Inagaki, Shinji Shimodera, Tatsuo Akechi, Mitsuhiko Yamada, Norio Watanabe, Gordon H. Guyatt
Direct improvement of quality of life in colorectal cancer patients using a tailored pathway with quality of life diagnosis and therapy (DIQOL): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Monika Klinkhammer-Schalke, Patricia Lindberg, Michael Koller, Jeremy C. Wyatt, Ferdinand Hofstädter, Wilfried Lorenz, Brunhilde Steinger
Chronic pain self-management support with pain science education and exercise (COMMENCE): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jordan Miller, Joy C. MacDermid, David M. Walton, Julie Richardson
Assessment of bone marrow-derived Cellular Therapy in progressive Multiple Sclerosis (ACTiMuS): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Claire M. Rice, David I. Marks, Yoav Ben-Shlomo, Nikos Evangelou, Paul S. Morgan, Chris Metcalfe, Peter Walsh, Nick M. Kane, Martin G. Guttridge, Gail Miflin, Stuart Blackmore, Pamela Sarkar, Juliana Redondo, Denise Owen, David A. Cottrell, Alastair Wilkins, Neil J. Scolding
Alternative forms of hydration in patients with cancer in the last days of life: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Andrew Davies, Melanie Waghorn, Julia Boyle, Ann Gallagher, Sigurd Johnsen
Fidelity considerations in translational research: Eating As Treatment — a stepped wedge, randomised controlled trial of a dietitian delivered behaviour change counselling intervention for head and neck cancer patients undergoing radiotherapy
- Open Access
- Study protocol
Alison Kate Beck, Amanda Baker, Ben Britton, Chris Wratten, Judith Bauer, Luke Wolfenden, Gregory Carter
The three stages of building and testing mid-level theories in a realist RCT: a theoretical and methodological case-example
- Open Access
- Methodology
Farah Jamal, Adam Fletcher, Nichola Shackleton, Diana Elbourne, Russell Viner, Chris Bonell
Interaction of titanium, zirconia and lithium disilicate with peri-implant soft tissue: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Katharina Kuhn, Heike Rudolph, Michael Graf, Matthias Moldan, Shaoxia Zhou, Martin Udart, Andrea Böhmler, Ralph G. Luthardt
Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis
- Open Access
- Research
Anouska Carter, Liam Humphreys, Nicky Snowdon, Basil Sharrack, Amanda Daley, Jane Petty, Nicola Woodroofe, John Saxton
Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Josielli Comachio, Mauricio Oliveira Magalhães, Thomaz Nogueira Burke, Luiz Armando Vidal Ramos, Gabriel Peixoto Leão Almeida, Ana Paula M. C. C. Silva, Sarah Rúbia Ferreira de Meneses, Jecilene Rosana Costa-Frutuoso, Cinthia Santos Miotto Amorim, Amélia Pasqual Marques
Screen-and-treat program by point-of-care of Atopobium vaginae and Gardnerella vaginalis in preventing preterm birth (AuTop trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Florence Bretelle, Florence Fenollar, Karine Baumstarck, Cécile Fortanier, Jean François Cocallemen, Valérie Serazin, Didier Raoult, Pascal Auquier, Sandrine Loubière
Postoperative negative-pressure incision therapy following open colorectal surgery (Poniy): study protocol for a randomized controlled trial
- Open Access
- Study protocol
André L. Mihaljevic, Rebekka Schirren, Tara C. Müller, Victoria Kehl, Helmut Friess, Jörg Kleeff
The Patient Remote Intervention and Symptom Management System (PRISMS) – a Telehealth- mediated intervention enabling real-time monitoring of chemotherapy side-effects in patients with haematological malignancies: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Sibilah Breen, David Ritchie, Penelope Schofield, Ya-seng Hsueh, Karla Gough, Nick Santamaria, Rose Kamateros, Roma Maguire, Nora Kearney, Sanchia Aranda
Projection of participant recruitment to primary care research: a qualitative study
- Open Access
- Research
David White, Daniel Hind
Danhong injection in the treatment of chronic stable angina: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Peng Qian Wang, Dan Dan Li, Wei Dong, Jun Liu, Ya Nan Yu, Chun Ti Shen, Qi Guang Chen, Bing Wei Chen, Yun Dai Chen, Zhong Wang
Opioid substitution and antagonist therapy trials exclude the common addiction patient: a systematic review and analysis of eligibility criteria
- Open Access
- Research
Brittany B. Dennis, Pavel S. Roshanov, Leen Naji, Monica Bawor, James Paul, Carolyn Plater, Guillaume Pare, Andrew Worster, Michael Varenbut, Jeff Daiter, David C. Marsh, Dipika Desai, Zainab Samaan, Lehana Thabane
Comparing three forms of early intervention for youth with borderline personality disorder (the MOBY study): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Andrew Chanen, Henry Jackson, Sue M. Cotton, John Gleeson, Christopher G. Davey, Jennifer Betts, Sophie Reid, Katherine Thompson, Louise McCutcheon
Treatment of traumatised refugees with basic body awareness therapy versus mixed physical activity as add-on treatment: Study protocol of a randomised controlled trial
- Open Access
- Study protocol
Maja Sticker Nordbrandt, Jessica Carlsson, Laura Glahder Lindberg, Hinuga Sandahl, Erik Lykke Mortensen
Detecting and Diagnosing Atrial Fibrillation (D2AF): study protocol for a cluster randomised controlled trial
- Open Access
- Study protocol
Steven B. Uittenbogaart, Nicole Verbiest-van Gurp, Petra M. G. Erkens, Wim A. M. Lucassen, J. André Knottnerus, Bjorn Winkens, Henk C. P. M. van Weert, Henri E. J. H. Stoffers
Would transcranial direct current stimulation (tDCS) enhance the effects of working memory training in older adults with mild neurocognitive disorder due to Alzheimer’s disease: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Calvin P. W. Cheng, Sandra S. M. Chan, Arthur D. P. Mak, Wai Chi Chan, Sheung Tak Cheng, Lin Shi, Defeng Wang, Linda Chiu-Wa Lam
Cognitive computer training in children with attention deficit hyperactivity disorder (ADHD) versus no intervention: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Aida Bikic, James F. Leckman, Jane Lindschou, Torben Ø. Christensen, Søren Dalsgaard
Fostering emotional, social, physical and educational wellbeing in rural India: the methods of a multi-arm randomized controlled trial of Girls First
- Open Access
- Methodology
Katherine Sachs Leventhal, Lisa M. DeMaria, Jane Gillham, Gracy Andrew, John W Peabody, Steve Leventhal
Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Kim Boshuisen, Herm J. Lamberink, Monique MJ van Schooneveld, J. Helen Cross, Alexis Arzimanoglou, Ingeborg van der Tweel, Karin Geleijns, Cuno SPM Uiterwaal, Kees PJ Braun
Effects of a prehabilitation program on patients’ recovery following spinal stenosis surgery: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Andrée-Anne Marchand, Margaux Suitner, Julie O’Shaughnessy, Claude-Édouard Châtillon, Vincent Cantin, Martin Descarreaux
Evaluation of interventions for informed consent for randomised controlled trials (ELICIT): protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey
- Open Access
- Study protocol
Katie Gillies, Vikki Entwistle, Shaun P. Treweek, Cynthia Fraser, Paula R. Williamson, Marion K. Campbell
Analysis of cervical resistance during continuous controllable balloon dilatation: controlled clinical and experimental study
- Open Access
- Research
Petar Arsenijevic, Marko Milosevic, Aleksandar Zivanovic, Biljana Milicic, Branislav Jeremic, Nenad Filipovic, Zoran Protrka, Petar Todorovic, Slobodan Arsenijevic
Mulberry extract to modULate Blood glucosE Responses in noRmoglYcaemic adults (MULBERRY): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Mark Lown, Richard Fuller, Helen Lightowler, Ann Fraser, Andrew Gallagher, Beth Stuart, Christopher D. Byrne, George Lewith
Ventricular tachycardia in ischemic cardiomyopathy; a combined endo-epicardial ablation as the first procedure versus a stepwise approach (EPILOGUE) – study protocol for a randomized controlled trial
- Open Access
- Study protocol
Astrid A. Hendriks, Muchtiar Khan, Laszlo Geller, Attila Kardos, Lennart J. de Vries, Sing-Chien Yap, Sip A. Wijchers, Dominic AMJ Theuns, Tamas Szili-Torok
Effectiveness of a transdiagnostic internet-based protocol for the treatment of emotional disorders versus treatment as usual in specialized care: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Alberto González-Robles, Azucena García-Palacios, Rosa Baños, Antonio Riera, Ginés Llorca, Francisco Traver, Gonzalo Haro, Vicente Palop, Guillem Lera, José Enrique Romeu, Cristina Botella
Effect of consuming novel foods consisting high oleic canola oil, barley β-glucan, and DHA on cardiovascular disease risk in humans: the CONFIDENCE (Canola Oil and Fibre with DHA Enhanced) study – protocol for a randomized controlled trial
- Open Access
- Study protocol
Vanu R. Ramprasath, Sijo J. Thandapilly, Shuo Yang, Anjalika Abraham, Peter J. H. Jones, Nancy Ames
Randomized controlled pilot of an intervention to reduce and break-up overweight/obese adults’ overall sitting-time
- Open Access
- Research
Pedro B. Júdice, Marc T. Hamilton, Luís B. Sardinha, Analiza M. Silva
A home-based rehabilitation intervention for people living with HIV and disability in a resource-poor community, KwaZulu-Natal: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Saul Cobbing, Jill Hanass-Hancock, Hellen Myezwa
Evaluation of multisystemic therapy pilot services in Services for Teens Engaging in Problem Sexual Behaviour (STEPS-B): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Peter Fonagy, Stephen Butler, Geoffrey Baruch, Sarah Byford, Michael C. Seto, James Wason, Charles Wells, Jessie Greisbach, Rachel Ellison, Elizabeth Simes
Kava for the treatment of generalised anxiety disorder (K-GAD): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Karen M. Savage, Con K. Stough, Gerard J. Byrne, Andrew Scholey, Chad Bousman, Jenifer Murphy, Patricia Macdonald, Chao Suo, Matthew Hughes, Stuart Thomas, Rolf Teschke, Chengguo Xing, Jerome Sarris
Memory Flexibility training (MemFlex) to reduce depressive symptomatology in individuals with major depressive disorder: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Caitlin Hitchcock, Emily Hammond, Catrin Rees, Inderpal Panesar, Peter Watson, Aliza Werner-Seidler, Tim Dalgleish
A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results
- Open Access
- Review
Tessa Kennedy-Martin, Sarah Curtis, Douglas Faries, Susan Robinson, Joseph Johnston
The cost-effectiveness analysis of JinQi Jiangtang tablets for the treatment on prediabetes: a randomized, double-blind, placebo-controlled, multicenter design
- Open Access
- Research
Xiao Sun, Liping Guo, Hongcai Shang, Ming Ren, Yue Wang, Da Huo, Xiang Lei, Hui Wang, Jingbo Zhai
Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial
- Open Access
- Study protocol
Tim E. Darsaut, Elsa Magro, Jean-Christophe Gentric, André Lima Batista, Chiraz Chaalala, David Roberge, Michel W. Bojanowski, Alain Weill, Daniel Roy, Jean Raymond
Application effect of extensively hydrolyzed milk protein formula and follow-up in preterm children with a gestational age of less than 34 weeks: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Li-Ping Yin, Li-Juan Qian, Huan Zhu, Yan Chen, Han Li, Ji-Nan Han, Li-Xing Qiao
Effects of exercise and horticultural intervention on the brain and mental health in older adults with depressive symptoms and memory problems: study protocol for a randomized controlled trial [UMIN000018547]
- Open Access
- Study protocol
Hyuma Makizako, Kota Tsutsumimoto, Takehiko Doi, Ryo Hotta, Sho Nakakubo, Teresa Liu-Ambrose, Hiroyuki Shimada
Effectiveness of septoplasty versus non-surgical management for nasal obstruction due to a deviated nasal septum in adults: study protocol for a randomized controlled trial
- Open Access
- Study protocol
M. M. H. T. van Egmond, M. M. Rovers, C. T. M. Hendriks, N. van Heerbeek
Self-Harm Intervention: Family Therapy (SHIFT), a study protocol for a randomised controlled trial of family therapy versus treatment as usual for young people seen after a second or subsequent episode of self-harm
- Open Access
- Study protocol
Alexandra Wright-Hughes, Elizabeth Graham, Amanda Farrin, Michelle Collinson, Paula Boston, Ivan Eisler, Sarah Fortune, Jonathan Green, Allan House, David Owens, Mima Simic, Sandy Tubeuf, Jane Nixon, Christopher McCabe, Michael Kerfoot, David Cottrell
The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research
- Open Access
- Research
E. Wilman, C. Megone, S. Oliver, L. Duley, G. Gyte, J. M. Wright
The OPVI trial – perioperative hemodynamic optimization using the plethysmographic variability index in orthopedic surgery: study protocol for a multicenter randomized controlled trial
- Open Access
- Study protocol
Marc-Olivier Fischer, Georges Daccache, Sandrine Lemoine, Benoît Tavernier, Vincent Compère, Christophe Hulet, Chems Eddine Bouchakour, Christophe Canevet, Jean-Louis Gérard, Lydia Guittet, Emmanuel Lorne, Jean-Luc Hanouz, Jean-Jacques Parienti
Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Patrick Murphy, Kevin Lee, Luc Dubois, Guy DeRose, Thomas Forbes, Adam Power
A new primary dental care service compared with standard care for child and family to reduce the re-occurrence of childhood dental caries (Dental RECUR): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Cynthia Pine, Pauline Adair, Girvan Burnside, Louise Robinson, Rhiannon Tudor Edwards, Sondos Albadri, Morag Curnow, Marjan Ghahreman, Mary Henderson, Clare Malies, Ferranti Wong, Vanessa Muirhead, Sally Weston-Price, Hilary Whitehead
Testing the effectiveness of a mentoring intervention to improve social participation of adolescents with visual impairments: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Eline C. M. Heppe, Sabina Kef, Carlo Schuengel
Preventing anxiety problems in children with Cool Little Kids Online: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Amy J. Morgan, Ronald M. Rapee, Elli Tamir, Nahal Goharpey, Agus Salim, Lauren F. McLellan, Jordana K. Bayer
Functional rehabilitation of upper limb apraxia in poststroke patients: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jose Manuel Pérez-Mármol, Mª Carmen García-Ríos, Francisco J. Barrero-Hernandez, Guadalupe Molina-Torres, Ted Brown, María Encarnación Aguilar-Ferrándiz
Baseline characteristics, analysis plan and report on feasibility for the Prevention Of Decline in Cognition After Stroke Trial (PODCAST)
- Open Access
- Research
Polly Scutt, Dan Blackburn, Kailash Krishnan, Clive Ballard, Alistair Burns, Gary A. Ford, Jonathan Mant, Peter Passmore, Stuart Pocock, John Reckless, Nikola Sprigg, Rob Stewart, Joanna M. Wardlaw, Philip M. Bath
How to assess success of treatment when using multiple doses: the case of misoprostol for medical abortion
- Open Access
- Methodology
Armando H. Seuc, Iqbal H. Shah, Moazzam Ali, Claudia Diaz-Olavarrieta, Marleen Temmerman
Effect of a high-dose target-controlled naloxone infusion on pain and hyperalgesia in patients following groin hernia repair: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Manuel Pedro Pereira, Mads Utke Werner, Joergen Berg Dahl
Graded Resistance Exercise And Type 2 Diabetes in Older adults (The GREAT2DO study): methods and baseline cohort characteristics of a randomized controlled trial
- Open Access
- Methodology
Kylie A. Simpson, Yorgi Mavros, Shelley Kay, Jacinda Meiklejohn, Nathan de Vos, Yi Wang, Qianyu Guo, Renru Zhao, Mike Climstein, Bernard T. Baune, Steven Blair, Anthony J. O’Sullivan, David Simar, Nalin Singh, Maria A. Fiatarone Singh
Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Helen Tilbrook, Rachael O. Forsythe, Debbie Rolfe, Laura Clark, Martin Bland, Hannah Buckley, Ian Chetter, Liz Cook, Jo Dumville, Rhian Gabe, Keith Harding, Alison Layton, Ellie Lindsay, Catriona McDaid, Christine Moffatt, Ceri Phillips, Gerard Stansby, Peter Vowden, Laurie Williams, David Torgerson, Robert J. Hinchliffe
The effect of Transcranial Direct Current Stimulation in addition to Tinnitus Retraining Therapy for treatment of chronic tinnitus patients: a study protocol for a double-blind controlled randomised trial
- Open Access
- Study protocol
Sarah Rabau, Vincent Van Rompaey, Paul Van de Heyning
The COMET initiative database: progress and activities update (2014)
- Open Access
- Letter
Elizabeth Gargon, Paula R. Williamson, Doug G. Altman, Jane M. Blazeby, Mike Clarke
“I never expected that it would happen, coming to ask me such questions”:Ethical aspects of asking children about violence in resource poor settings
- Open Access
- Methodology
Karen M. Devries, Jennifer C. Child, Diana Elbourne, Dipak Naker, Lori Heise
Statistical analysis plan for the Laser-1st versus Drops-1st for Glaucoma and Ocular Hypertension Trial (LiGHT): a multi-centre randomised controlled trial
- Open Access
- Update
Victoria Vickerstaff, Gareth Ambler, Catey Bunce, Wen Xing, Gus Gazzard, Gus Gazzard, Sarah Wilson, David Broadway, Sheng Lim, Rupert Bourne, Timothy Manners, Nicholas Strouthidis, Keith Barton, Richard Wormald, Stephen Morris, Rachael Hunter, Gary Rubin, David Garway-Heath, Marta Buszewicz, Gareth Ambler, Catey Bunce, Victoria Vickerstaff, Amanda Davis, Neil Nathwani, Evgenia Konstantakopoulou, Haogang Zhou, Yuzhen Jiang
Quality of outcome reporting in phase II studies in pulmonary tuberculosis
- Open Access
- Review
Laura Jayne Bonnett, Geraint Rhys Davies
The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Michael D. Jenkinson, Mohsen Javadpour, Brian J. Haylock, Bridget Young, Helen Gillard, Jacqui Vinten, Helen Bulbeck, Kumar Das, Michael Farrell, Seamus Looby, Helen Hickey, Mattheus Preusser, Conor L. Mallucci, Dyfrig Hughes, Carrol Gamble, Damien C. Weber
Common beans and cowpeas as complementary foods to reduce environmental enteric dysfunction and stunting in Malawian children: study protocol for two randomized controlled trials
- Open Access
- Study protocol
Indi Trehan, Nicole S. Benzoni, Alfred Z. Wang, Lucy B. Bollinger, Theresa N. Ngoma, Ulemu K. Chimimba, Kevin B. Stephenson, Sophia E. Agapova, Kenneth M. Maleta, Mark J. Manary
Antihyperglycemic effect of short-term arginyl-fructose supplementation in subjects with prediabetes and newly diagnosed type 2 diabetes: randomized, double-blinded, placebo-controlled trial
- Open Access
- Research
Su Eun Park, Ok-Hwan Kim, Jung Hyun Kwak, Kwang-Hyoung Lee, Young-In Kwon, Kwang Hoe Chung, Jong Ho Lee
Generalizing boundaries for triangular designs, and efficacy estimation at extended follow-ups
- Open Access
- Methodology
Annabel Allison, Tansy Edwards, Raymond Omollo, Fabiana Alves, Dominic Magirr, Neal D. E. Alexander
Dichotomizing partial compliance and increased participant burden in factorial designs: the performance of four noncompliance methods
- Open Access
- Research
Peter D. Merrill, Leslie A. McClure
Involuntary reflexive pelvic floor muscle training in addition to standard training versus standard training alone for women with stress urinary incontinence: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Helena Luginbuehl, Corinne Lehmann, Jean-Pierre Baeyens, Annette Kuhn, Lorenz Radlinger
Comparative effectiveness of electro-acupuncture plus lifestyle modification treatment for patients with simple obesity and overweight: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Zishan Gao, Zhi Yu, Zhi-Xiu Song, Cai-Rong Zhang, Yao-Shuai Wang, Yun-Feng Wu, Bei Zhou, Shu-Ping Fu, Hao Chen, Ying Xiong, Yi Yang, Bing-Mei Zhu, Bin Xu
Cognitive behavioural treatment for mild Alzheimer’s patients and their caregivers (CBTAC): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Simon Forstmeier, Andreas Maercker, Egemen Savaskan, Tanja Roth
PIMS (Positioning In Macular hole Surgery) trial – a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Saruban Pasu, Catey Bunce, Richard Hooper, Ann Thomson, James Bainbridge
Effect of ATorvastatin On Chronic subdural Hematoma (ATOCH): a study protocol for a randomized controlled trial
- Open Access
- Study protocol
Rongcai Jiang, Dong Wang, Wai Sang Poon, Yi Cheng Lu, Xin Gang Li, Shi Guang Zhao, Ren Zhi Wang, Chao You, Xian Rui Yuan, Jian Min Zhang, Hua Feng, Zhou Fei, Xin Guang Yu, Yuan Li Zhao, Jin Hu, De Zhi Kang, Ru Tong Yu, Guo Dong Gao, Xi De Zhu, Tao Sun, Jie He Hao, Xian Zhi Liu, Ning Su, Shu Yuan Yue, Jian Ning Zhang
An evaluation of the DEXLIFE ‘self-selected’ lifestyle intervention aimed at improving insulin sensitivity in people at risk of developing type 2 diabetes: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Grainne M. O’Donoghue, Aileen Kennedy, Gregers Stig Andersen, Eoin Durkan, Tanja Thybo, Margaret Sinnott, John J. Nolan, Donal J. O’Gorman
A randomized pilot study on the effect of niacin on pulmonary arterial pressure
- Open Access
- Research
Martin J. McNamara, Jason J. Sayanlar, Daniel J. Dooley, Monvadi B. Srichai, Allen J. Taylor
A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study
- Open Access
- Research
David J. Bowrey, Melanie Baker, Vanessa Halliday, Anne L. Thomas, Ruth Pulikottil-Jacob, Karen Smith, Tom Morris, Arne Ring
Efficacy and cost-effectiveness of intradiscal methylene blue injection for chronic discogenic low back pain: study protocol for a randomized controlled trial
- Open Access
- Study protocol
José W. Geurts, Jan-Willem Kallewaard, Alfons Kessels, Paul C. Willems, Henk van Santbrink, Carmen Dirksen, Maarten van Kleef
Transfusion strategy in hematological intensive care unit: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Sylvain P. Chantepie, Jean-Baptiste Mear, Lydia Guittet, Benoît Dervaux, Jean-Pierre Marolleau, Fabrice Jardin, Jean-Jacques Dutheil, Jean-Jacques Parienti, Jean-Pierre Vilque, Oumedaly Reman
The effectiveness and cost-effectiveness of the peer-delivered Thinking Healthy Programme for perinatal depression in Pakistan and India: the SHARE study protocol for randomised controlled trials
- Open Access
- Study protocol
Siham Sikander, Anisha Lazarus, Omer Bangash, Daniela C. Fuhr, Benedict Weobong, Revathi N. Krishna, Ikhlaq Ahmad, Helen A. Weiss, LeShawndra Price, Atif Rahman, Vikram Patel
Evaluation of recruitment methods for a trial targeting childhood obesity: Families for Health randomised controlled trial
- Open Access
- Research
J. Fleming, A. Kamal, E. Harrison, T. Hamborg, S. Stewart-Brown, M. Thorogood, F. Griffiths, W. Robertson
Effects of propranolol on fear of dental extraction: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Serge A. Steenen, Arjen J. van Wijk, Roos van Westrhenen, Jan de Lange, Ad de Jongh
PERC rule to exclude the diagnosis of pulmonary embolism in emergency low-risk patients: study protocol for the PROPER randomized controlled study
- Open Access
- Study protocol
Yonathan Freund, Alexandra Rousseau, France Guyot-Rousseau, Yann-Erick Claessens, Olivier Hugli, Olivier Sanchez, Tabassome Simon, Bruno Riou
Cognitive behaviour therapy for older adults experiencing insomnia and depression in a community mental health setting: Study protocol for a randomised controlled trial
- Open Access
- Study protocol
Paul Sadler, Suzanne McLaren, Britt Klein, Megan Jenkins, Jack Harvey
A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Yanan Wang, Ruoyan Liu, Ze Zhang, Qi Xue, Jun Yan, Jiang Yu, Hao Liu, Liying Zhao, Tingyu Mou, Haijun Deng, Guoxin Li
Pulmonary wedge resection plus parietal pleurectomy (WRPP) versus parietal pleurectomy (PP) for the treatment of recurrent primary pneumothorax (WOPP trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jens Neudecker, Uwe Malzahn, Peter Heuschmann, Uwe Behrens, Thorsten Walles
Bounding the per-protocol effect in randomized trials: an application to colorectal cancer screening
- Open Access
- Methodology
Sonja A. Swanson, Øyvind Holme, Magnus Løberg, Mette Kalager, Michael Bretthauer, Geir Hoff, Eline Aas, Miguel A. Hernán
Improving the organisation of maternal health service delivery and optimising childbirth by increasing vaginal birth after caesarean section through enhanced women-centred care (OptiBIRTH trial): study protocol for a randomised controlled trial (ISRCTN10612254)
- Open Access
- Study protocol
Mike Clarke, Gerard Savage, Valerie Smith, Deirdre Daly, Declan Devane, Mechthild M. Gross, Susanne Grylka-Baeschlin, Patricia Healy, Sandra Morano, Jane Nicoletti, Cecily Begley
Are urgent care centers a viable venue for recruitment in clinical trials?
- Open Access
- Letter
Hersh V. Goel, Trevor A. Jones, David P. Skinner Jr.
Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Adrian R. Allen, Jill M. Newby, Jessica Smith, Gavin Andrews
A core outcome set for all types of cardiac surgery effectiveness trials: a study protocol for an international eDelphi survey to achieve consensus on what to measure and the subsequent selection of measurement instruments
- Open Access
- Study protocol
A. Moza, C. Benstoem, R. Autschbach, C. Stoppe, A. Goetzenich
Effects of acupuncture and computer-assisted cognitive training for post-stroke attention deficits: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jia Huang, Michael A. McCaskey, Shanli Yang, Haicheng Ye, Jing Tao, Cai Jiang, Corina Schuster-Amft, Christian Balzer, Thierry Ettlin, Wilfried Schupp, Hartwig Kulke, Lidian Chen
Effectiveness of a self-management intervention with personalised genetic and lifestyle-related risk information on coronary heart disease and diabetes-related risk in type 2 diabetes (CoRDia): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Anna K. Davies, Nadine McGale, Steve E. Humphries, Shashivadan P. Hirani, Katherine E. Beaney, Dauda A. S. Bappa, John G. McCabe, Stanton P. Newman
Clinical outcomes and neural correlates of 20 sessions of repetitive transcranial magnetic stimulation in severe and enduring anorexia nervosa (the TIARA study): study protocol for a randomised controlled feasibility trial
- Open Access
- Study protocol
Savani Bartholdy, Jessica McClelland, Maria Kekic, Owen G. O’Daly, Iain C. Campbell, Jessica Werthmann, Samantha J. Rennalls, Katya Rubia, Anthony S. David, Danielle Glennon, Nikola Kern, Ulrike Schmidt
The impact of a computerized decision aid on empowering pregnant women for choosing vaginal versus cesarean section delivery: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Saeid Eslami, Azam Aslani, Fatemeh Tara, Leila Ghalichi, Fatemeh Erfanian, Ameen Abu-Hanna
Botulinum neurotoxin type A in the treatment of classical Trigeminal Neuralgia (BoTN): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jan Burmeister, Dagny Holle, Eva Bock, Claudia Ose, Hans-Christoph Diener, Mark Obermann
Evaluation of the effectiveness of photodynamic therapy for the endodontic treatment of primary teeth: study protocol for a randomized controlled clinical trial
- Open Access
- Study protocol
Ana Carolina Costa da Mota, Marcela Leticia Leal Gonçalves, Carolina Bortoletto, Silvia Regina Olivan, Monica Salgueiro, Camila Godoy, Olga Maria Altavista, Marcelo Mendes Pinto, Anna Carolina Horliana, Lara J. Motta, Sandra Kalil Bussadori
Mitigating aflatoxin exposure to improve child growth in Eastern Kenya: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Vivian Hoffmann, Kelly Jones, Jef Leroy
FitForLife: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Yvonne Forsell, Mats Hallgren, Maria Mattson, Orjan Ekblom, Catharina Lavebratt
The Danish Cardiovascular Screening Trial (DANCAVAS): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Axel Cosmus Pyndt Diederichsen, Lars Melholt Rasmussen, Rikke Søgaard, Jess Lambrechtsen, Flemming Hald Steffensen, Lars Frost, Kenneth Egstrup, Grazina Urbonaviciene, Martin Busk, Michael Hecht Olsen, Hans Mickley, Jesper Hallas, Jes Sanddal Lindholt
A theory-based online health behaviour intervention for new university students (U@Uni:LifeGuide): results from a repeat randomized controlled trial
- Open Access
- Research
David Cameron, Tracy Epton, Paul Norman, Paschal Sheeran, Peter R. Harris, Thomas L. Webb, Steven A. Julious, Alan Brennan, Chloe Thomas, Andrea Petroczi, Declan Naughton, Iltaf Shah
Cognitive Rehabilitation for Attention and Memory in people with Multiple Sclerosis: study protocol for a randomised controlled trial (CRAMMS)
- Open Access
- Study protocol
Nadina B. Lincoln, Roshan das Nair, Lucy Bradshaw, Cris S. Constantinescu, Avril E. R. Drummond, Alexandra Erven, Amy L. Evans, Deborah Fitzsimmons, Alan A. Montgomery, Miriam Morgan
Effects of high-intensity aerobic exercise on psychotic symptoms and neurocognition in outpatients with schizophrenia: study protocol for a randomized controlled trial
- Open Access
- Study protocol
John A. Engh, Eivind Andersen, Tom L. Holmen, Egil W. Martinsen, Jon Mordal, Gunnar Morken, Jens Egeland
Can Healthcare Assistant Training (CHAT) improve the relational care of older people? Study protocol for a pilot cluster randomised controlled trial
- Open Access
- Study protocol
Antony Arthur, Jill Maben, Heather Wharrad, Clare Aldus, Sophie Sarre, Justine Schneider, Caroline Nicholson, Garry Barton, Karen Cox, Allan Clark
The use of volatile anesthetic agents for long-term critical care sedation (VALTS): study protocol for a pilot randomized controlled trial
- Open Access
- Study protocol
Angela Jerath, Niall D. Ferguson, Andrew Steel, Duminda Wijeysundera, John Macdonald, Marcin Wasowicz
Evaluating the effects of Danhong injection in treatment of acute ischemic stroke: study protocol for a multicenter randomized controlled trial
- Open Access
- Study protocol
Bing Li, Yilong Wang, Jingjing Lu, Jun Liu, Ye Yuan, Yanan Yu, Pengqian Wang, Xingquan Zhao, Zhong Wang
Continuous wound infiltration or epidural analgesia for pain prevention after hepato-pancreato-biliary surgery within an enhanced recovery program (POP-UP trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Timothy H. Mungroop, Denise P. Veelo, Olivier R. Busch, Susan van Dieren, Thomas M. van Gulik, Tom M. Karsten, Steve M. de Castro, Marc B. Godfried, Bram Thiel, Markus W. Hollmann, Philipp Lirk, Marc G. Besselink
The effect of iodine supplementation in pregnancy on early childhood neurodevelopment and clinical outcomes: results of an aborted randomised placebo-controlled trial
- Open Access
- Research
Shao J. Zhou, Sheila A. Skeaff, Philip Ryan, Lex W. Doyle, Peter J. Anderson, Louise Kornman, Andrew J. Mcphee, Lisa N. Yelland, Maria Makrides
Recruitment and retention in obesity prevention and treatment trials targeting minority or low-income children: a review of the clinical trials registration database
- Open Access
- Research
Zhaohui Cui, Elisabeth M. Seburg, Nancy E. Sherwood, Myles S. Faith, Dianne S. Ward
Continence Across Continents To Upend Stigma and Dependency (CACTUS-D): study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Cara Tannenbaum, Eleanor van den Heuvel, Xavier Fritel, Kenneth Southall, Jeffrey Jutai, Saima Rajabali, Adrian Wagg
SRT-Joy – computer-assisted self-regulation training for obese children and adolescents: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Petra Warschburger
Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM) for diagnosis and management of bladder outlet obstruction in men: study protocol for a randomised controlled trial
- Open Access
- Study protocol
K. Bailey, P. Abrams, P. S. Blair, C. Chapple, C. Glazener, J. Horwood, J. A. Lane, J. McGrath, S. Noble, R. Pickard, G. Taylor, G. J. Young, M. J. Drake, A. L. Lewis
Preoperative versus postoperative ultrasound-guided rectus sheath block for improving pain, sleep quality and cytokine levels of patients with open midline incisions undergoing transabdominal gynaecological operation: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Feng Jin, Xiao-qian Li, Wen-fei Tan, Hong Ma, Huang-wei Lu
The Italian Diabetes and Exercise Study 2 (IDES-2): a long-term behavioral intervention for adoption and maintenance of a physically active lifestyle
- Open Access
- Study protocol
Stefano Balducci, Massimo Sacchetti, Jonida Haxhi, Giorgio Orlando, Silvano Zanuso, Patrizia Cardelli, Stefano Cavallo, Valeria D’Errico, Maria Cristina Ribaudo, Nicolina Di Biase, Laura Salvi, Martina Vitale, Lucilla Bollanti, Francesco G. Conti, Antonio Nicolucci, Giuseppe Pugliese
The advance care planning PREPARE study among older Veterans with serious and chronic illness: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Rebecca Sudore, Gem M. Le, Ryan McMahan, Mariko Feuz, Mary Katen, Deborah E. Barnes
Effects of postural specific sensorimotor training in patients with chronic low back pain: study protocol for randomised controlled trial
- Open Access
- Study protocol
Michael A. McCaskey, Corina Schuster-Amft, Brigitte Wirth, Eling D. de Bruin
Evaluation of acute effect of light-emitting diode (LED) phototherapy on muscle deoxygenation and pulmonary oxygen uptake kinetics in patients with diabetes mellitus: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Cristina de Oliveira Francisco, Thomas Beltrame, Cleber Ferraresi, Nivaldo Antonio Parizotto, Vanderlei Salvador Bagnato, Audrey Borghi Silva, Benedito Galvão Benze, Alberto Porta, Aparecida Maria Catai
The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial
- Open Access
- Study protocol
Ianthe Boden, Laura Browning, Elizabeth H. Skinner, Julie Reeve, Doa El-Ansary, Iain K. Robertson, Linda Denehy
Remedial after-school support classes offered in rural Gambia (The SCORE trial): study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Peter Boone, Alpha Camara, Alex Eble, Diana Elbourne, Samory Fernandes, Chris Frost, Chitra Jayanty, Maitri Lenin, Ana Filipa Silva
Phase II/III weekly nab-paclitaxel plus gemcitabine or carboplatin versus gemcitabine/carboplatin as first-line treatment of patients with metastatic triple-negative breast cancer (the tnAcity study): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Denise A. Yardley, Adam Brufsky, Robert E. Coleman, Pierfranco F. Conte, Javier Cortes, Stefan Glück, Jean-Mark A. Nabholtz, Joyce O’Shaughnessy, Robert M. Beck, Amy Ko, Markus F. Renschler, Debora Barton, Nadia Harbeck
Informal Health Provider and Practical Approach to Lung Health interventions to improve the detection of chronic airways disease and tuberculosis at primary care level in Malawi: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Hastings T Banda, Kevin Mortimer, George AF Bello, Grace B Mbera, Ireen Namakhoma, Rachael Thomson, Moffat J Nyirenda, Brian Faragher, Jason Madan, Rasmus Malmborg, Berthe Stenberg, James Mpunga, Beatrice Mwagomba, Elvis Gama, Katherine Piddock, Stephen B Squire
Health care professionals’ views of the factors influencing the decision to refer patients to a stroke rehabilitation trial
- Open Access
- Research
Nessa Thomas, Sarah Plant, Kate Woodward-Nutt, Yeliz Prior, Sarah Tyson
Comparing cognitive behavioural therapy for eating disorders integrated with behavioural weight loss therapy to cognitive behavioural therapy-enhanced alone in overweight or obese people with bulimia nervosa or binge eating disorder: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Marly Amorim Palavras, Phillipa Hay, Stephen Touyz, Amanda Sainsbury, Felipe da Luz, Jessica Swinbourne, Nara Mendes Estella, Angélica Claudino
The Happy Older Latinos are Active (HOLA) health promotion and prevention study: study protocol for a pilot randomized controlled trial
- Open Access
- Study protocol
Daniel E. Jimenez, Charles F. Reynolds III, Margarita Alegría, Philip Harvey, Stephen J. Bartels
Uterine Tonus Assessment by Midwives versus Patient self-assessment in the active management of the third stage of labor (UTAMP): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Joyce L. Browne, Nelson K. R. Damale, Tessa M. Raams, Eva L. Van der Linden, Ernest T. Maya, Roseline Doe, Marcus J. Rijken, Richard Adanu, Diederick E. Grobbee, Arie Franx, Kerstin Klipstein-Grobusch
The renin-angiotensin receptor blocker azilsartan medoxomil compared with the angiotensin-converting enzyme inhibitor ramipril in clinical trials versus routine practice: insights from the prospective EARLY registry
- Open Access
- Research
Peter Bramlage, Roland E. Schmieder, Anselm K. Gitt, Peter Baumgart, Felix Mahfoud, Hartmut Buhck, Taoufik Ouarrak, Martina Ehmen, Sebastian A. Potthoff
Fluid loading in abdominal surgery - saline versus hydroxyethyl starch (FLASH Trial): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Emmanuel Futier, Matthieu Biais, Thomas Godet, Lise Bernard, Christine Rolhion, Justine Bourdier, Dominique Morand, Bruno Pereira, Samir Jaber
Oral versus intravenous antibiotic treatment for bone and joint infections (OVIVA): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Ho Kwong Li, Matthew Scarborough, Rhea Zambellas, Cushla Cooper, Ines Rombach, A. Sarah Walker, Benjamin A. Lipsky, Andrew Briggs, Andrew Seaton, Bridget Atkins, Andrew Woodhouse, Anthony Berendt, Ivor Byren, Brian Angus, Hemant Pandit, David Stubbs, Martin McNally, Guy Thwaites, Philip Bejon
Does statin use have a disease modifying effect in symptomatic knee osteoarthritis? Study protocol for a randomised controlled trial
- Open Access
- Study protocol
Yuanyuan Wang, Andrew Tonkin, Graeme Jones, Catherine Hill, Changhai Ding, Anita E. Wluka, Andrew Forbes, Flavia M. Cicuttini
Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials
- Open Access
- Research
Munyaradzi Dimairo, Steven A. Julious, Susan Todd, Jonathan P. Nicholl, Jonathan Boote
The effects of a strength and neuromuscular exercise programme for the lower extremity on knee load, pain and function in obese children and adolescents: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Brian Horsak, David Artner, Arnold Baca, Barbara Pobatschnig, Susanne Greber-Platzer, Stefan Nehrer, Barbara Wondrasch
Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial
- Open Access
- Study protocol
Emma J. Ridley, Andrew R. Davies, Rachael Parke, Michael Bailey, Colin McArthur, Lyn Gillanders, David J. Cooper, Shay McGuinness
Facet-joint injections for people with persistent non-specific low back pain (FIS): study protocol for a randomised controlled feasibility trial
- Open Access
- Study protocol
Harbinder Sandhu, David R. Ellard, Felix Achana, James H. L. Antrobus, Shyam Balasubramanian, Sally Brown, Melinda Cairns, Frances Griffiths, Kirstie Haywood, Charles Hutchinson, Ranjit Lall, Stavros Petrou, Nigel Stallard, Colin Tysall, David A. Walsh, Martin Underwood
Novel ways to explore surgical interventions in randomised controlled trials: applying case study methodology in the operating theatre
- Open Access
- Methodology
Natalie S. Blencowe, Jane M. Blazeby, Jenny L. Donovan, Nicola Mills
Making smart investment decisions in clinical research
- Open Access
- Commentary
Nick Bansback, Edward Keystone, James O’Dell, Ciaran S. Phibbs, Keri Hannagan, Mary Brophy, Aslam Anis
Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness
- Open Access
- Research
Nina H. Gobat, Micaela Gal, Nick A. Francis, Kerenza Hood, Angela Watkins, Jill Turner, Ronald Moore, Steve A. R. Webb, Christopher C. Butler, Alistair Nichol
Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jianhui Zhou, Xueying Cao, Hongli Lin, Zhaohui Ni, Yani He, Menghua Chen, Hongguang Zheng, Xiangmei Chen
Transfusion and Treatment of severe anaemia in African children (TRACT): a study protocol for a randomised controlled trial
- Open Access
- Study protocol
Ayub Mpoya, Sarah Kiguli, Peter Olupot-Olupot, Robert O. Opoka, Charles Engoru, Macpherson Mallewa, Yami Chimalizeni, Neil Kennedy, Dorothy Kyeyune, Benjamin Wabwire, Bridon M’baya, Imelda Bates, Britta Urban, Michael Boele von Hensbroek, Robert Heyderman, Margaret J. Thomason, Sophie Uyoga, Thomas N. Williams, Diana M. Gibb, Elizabeth C. George, A. Sarah Walker, Kathryn Maitland
Remote ischemic preconditioning in the prevention of ischemic brain damage during intracranial aneurysm treatment (RIPAT): study protocol for a randomized controlled trial
- Open Access
- Study protocol
Selma Tülü, Miriam Mulino, Daniel Pinggera, Markus Luger, Philipp Würtinger, Astrid Grams, Thomas Bodner, Ronny Beer, Raimund Helbok, Raffaella Matteucci-Gothe, Claudia Unterhofer, Elke Gizewski, Erich Schmutzhard, Claudius Thomé, Martin Ortler
BEAT-IT: Comparing a behavioural activation treatment for depression in adults with intellectual disabilities with an attention control: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Andrew Jahoda, Craig Melville, Sally-Ann Cooper, Richard Hastings, Andrew Briggs, Dave Dagnan, Chris Hatton, Alex McConnachie, Chris Williams, Robert S. P. Jones
Dorsal penile nerve block with ropivacaine versus intravenous tramadol for the prevention of catheter-related bladder discomfort: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Jing-yi Li, Ren Liao
Exploring the role and function of trial steering committees: results of an expert panel meeting
- Open Access
- Research
Nicola L. Harman, Elizabeth J. Conroy, Steff C. Lewis, Gordon Murray, John Norrie, Matt R. Sydes, J. Athene Lane, Douglas G. Altman, Colin Baigent, Judith M. Bliss, Marion K. Campbell, Diana Elbourne, Stephen Evans, Peter Sandercock, Carrol Gamble
Biliary reconstruction with or without an intraductal removable stent in liver transplantation: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Claire Goumard, Marine Cachanado, Astrid Herrero, Géraldine Rousseau, Federica Dondero, Philippe Compagnon, Emmanuel Boleslawski, Jean Yves Mabrut, Ephrem Salamé, Olivier Soubrane, Tabassome Simon, Olivier Scatton
The Karnataka Anemia Project 2 — design and evaluation of a community-based parental intervention to improve childhood anemia cure rates: study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Arun S. Shet, Merrick Zwarenstein, Maya Mascarenhas, Arvind Risbud, Salla Atkins, Neil Klar, Maria Rosaria Galanti
Open urethroplasty versus endoscopic urethrotomy - clarifying the management of men with recurrent urethral stricture (the OPEN trial): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Rachel Stephenson, Sonya Carnell, Nicola Johnson, Robbie Brown, Jennifer Wilkinson, Anthony Mundy, Steven Payne, Nick Watkin, James N’Dow, Andrew Sinclair, Rowland Rees, Stewart Barclay, Jonathan A. Cook, Beatriz Goulao, Graeme MacLennan, Gladys McPherson, Matthew Jackson, Tim Rapley, Jing Shen, Luke Vale, John Norrie, Elaine McColl, Robert Pickard
Early exercise after spinal cord injury (‘Switch-On’): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Mary P Galea, Sarah A Dunlop, Ruth Marshall, Jillian Clark, Leonid Churilov
Effectiveness of a computerized drug-monitoring program to detect and prevent adverse drug events and medication non-adherence in outpatient ambulatory care: study protocol of a randomized controlled trial
- Open Access
- Study protocol
Alan J Forster, Tobias E Erlanger, Alison Jennings, Claudine Auger, David Buckeridge, Carl van Walraven, Robyn Tamblyn
A randomised double-blind placebo-controlled 12- week feasibility trial of methotrexate added to treatment as usual in early schizophrenia: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Imran B Chaudhry, Nusrat Husain, Raza ur Rahman, Mohammed Omair Husain, Mohammed M Hamirani, Ajmal Kazmi, Shakeel Baig, Peter M Haddad, Maya H Buch, Inti Qureshi, Nasir Mehmood, Tayyeba Kiran, Bo Fu, Salahuddin Afsar, Bill Deakin
Rehabilitation of Memory following Brain Injury (ReMemBrIn): study protocol for a randomised controlled trial
- Open Access
- Study protocol
Roshan das Nair, Nadina B Lincoln, Deborah Ftizsimmons, Nicola Brain, Alan Montgomery, Lucy Bradshaw, Avril Drummond, Catherine Sackley, Gavin Newby, Jim Thornton, Sandip Stapleton, Anthony Pink
Derivation and validation phase for the development of clinical prediction rules for rehabilitation in chronic nonspecific low back pain patients: study protocol for a randomized controlled trial
- Open Access
- Study protocol
Lenie Denteneer, Gaetane Stassijns, Willem De Hertogh, Steven Truijen, Nienke Jansen, Ulrike Van Daele
Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial
- Open Access
- Study protocol
Charlotte Holm, Lars Lykke Thomsen, Astrid Norgaard, Jens Langhoff-Roos
Uncovering the emotional aspects of working on a clinical trial: a qualitative study of the experiences and views of staff involved in a type 1 diabetes trial
- Open Access
- Research
Julia Lawton, Jackie Kirkham, David White, David Rankin, Cindy Cooper, Simon Heller
Effectiveness of score card-based antenatal risk selection, care pathways, and multidisciplinary consultation in the Healthy Pregnancy 4 All study (HP4ALL): study protocol for a cluster randomized controlled trial
- Open Access
- Study protocol
Amber A Vos, Sabine F van Voorst, Adja JM Waelput, Lieke C de Jong-Potjer, Gouke J Bonsel, Eric AP Steegers, Semiha Denktaş
Lessons learned from recruiting socioeconomically disadvantaged smokers into a pilot randomized controlled trial to explore the role of Exercise Assisted Reduction then Stop (EARS) smoking
- Open Access
- Methodology
Tom P Thompson, Colin J Greaves, Richard Ayres, Paul Aveyard, Fiona C Warren, Richard Byng, Rod S Taylor, John L Campbell, Michael Ussher, Susan Michie, Robert West, Adrian H Taylor
