Ausgabe 1/2018
Inhalt (715 Artikel)
Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial
Thijs de Rooij, Jony van Hilst, Koop Bosscha, Marcel G. Dijkgraaf, Michael F. Gerhards, Bas Groot Koerkamp, Jeroen Hagendoorn, Ignace H. de Hingh, Tom M. Karsten, Daan J. Lips, Misha D. Luyer, I. Quintus Molenaar, Hjalmar C. van Santvoort, T. C. Khé Tran, Olivier R. Busch, Sebastiaan Festen, Marc G. Besselink
Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial
Hong Pan, Yingxia Pei, Bingxue Li, Yi Wang, Jie Liu, Hongsheng Lin
Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial
Daren K. Heyland, Judy Davidson, Yoanna Skrobik, Amanda Roze des Ordons, Lauren J. Van Scoy, Andrew G. Day, Virginia Vandall-Walker, Andrea P. Marshall
Effectiveness of a psycho-educational intervention to prevent postpartum parental distress and enhance infant well-being: study protocol of a randomized controlled trial
Marjolein Missler, Roseriet Beijers, Jaap Denissen, Annemieke van Straten
A randomised pragmatic trial of corticosteroid optimization in severe asthma using a composite biomarker algorithm to adjust corticosteroid dose versus standard care: study protocol for a randomised trial
Catherine E. Hanratty, John G. Matthews, Joseph R. Arron, David F. Choy, Ian D. Pavord, P. Bradding, Christopher E. Brightling, Rekha Chaudhuri, Douglas C. Cowan, Ratko Djukanovic, Nicola Gallagher, Stephen J. Fowler, Tim C. Hardman, Tim Harrison, Cécile T. Holweg, Peter H. Howarth, James Lordan, Adel H. Mansur, Andrew Menzies-Gow, Sofia Mosesova, Robert M. Niven, Douglas S. Robinson, Dominick E. Shaw, Samantha Walker, Ashley Woodcock, Liam G. Heaney, I. Adcock, A. Boriello, M. Catley, K. F. Chung, R. W. Costello, S. Johnston, F. Keane, R. May, L. Pierre, D. Smith, C. Stevenson, V. Hudson, D. Supple
Leucine and ACE inhibitors as therapies for sarcopenia (LACE trial): study protocol for a randomised controlled trial
Margaret M. Band, Deepa Sumukadas, Allan D. Struthers, Alison Avenell, Peter T. Donnan, Paul R. Kemp, Karen T. Smith, Cheryl L. Hume, Adrian Hapca, Miles D. Witham
Personalized upper limb training combined with anodal-tDCS for sensorimotor recovery in spastic hemiparesis: study protocol for a randomized controlled trial
Mindy F. Levin, Melanie C. Baniña , Silvi Frenkel-Toledo, Sigal Berman, Nachum Soroker, John M. Solomon, Dario G. Liebermann
Combined electroacupuncture and auricular acupuncture for postoperative pain after abdominal surgery for gynecological diseases: study protocol for a randomized controlled trial
Wing Lok Lam, Wing Fai Yeung, Mei Kuen Wong, Chi Wai Cheung, Karen Kar Loen Chan, Hextan Yuen Sheung Ngan, Carlos King Ho Wong, Hai Yong Chen, Lixing Lao
Process evaluation for OptiBIRTH, a randomised controlled trial of a complex intervention designed to increase rates of vaginal birth after caesarean section
Patricia Healy, Valerie Smith, Gerard Savage, Mike Clarke, Declan Devane, Mechthild M. Gross, Sandra Morano, Deirdre Daly, Susanne Grylka-Baeschlin, Jane Nicoletti, Marlene Sinclair, Rebekah Maguire, Margaret Carroll, Cecily Begley
Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients
Timothy F. Platts-Mills, Allison G. Hollowell, Gary F. Burke, Sheryl Zimmerman, Joseph A. Dayaa, Benjamin R. Quigley, Montika Bush, Morris Weinberger, Mark A. Weaver
Trial management– building the evidence base for decision-making
Shaun Treweek, Roberta Littleford
Effect of eicosapentaenoic acid/docosahexaenoic acid on coronary high-intensity plaques detected with non-contrast T1-weighted imaging (the AQUAMARINE EPA/DHA study): study protocol for a randomized controlled trial
Kazuhiro Nakao, Teruo Noguchi, Yasuhide Asaumi, Yoshiaki Morita, Tomoaki Kanaya, Masashi Fujino, Hayato Hosoda, Shuichi Yoneda, Shoji Kawakami, Toshiyuki Nagai, Kensaku Nishihira, Takahiro Nakashima, Reon Kumasaka, Tetsuo Arakawa, Fumiyuki Otsuka, Michio Nakanishi, Yu Kataoka, Yoshio Tahara, Yoichi Goto, Haruko Yamamoto, Toshimitsu Hamasaki, Satoshi Yasuda
Comparison of outcome measures and complication rates following three different approaches for primary total hip arthroplasty: a pragmatic randomised controlled trial
Adrian J. Talia, Cassandra Coetzee, Oren Tirosh, Phong Tran
Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial
Erik Lundström, Eva Isaksson, Per Wester, Ann-Charlotte Laska, Per Näsman
What are the main inefficiencies in trial conduct: a survey of UKCRC registered clinical trials units in the UK
Lelia Duley, Alexa Gillman, Marian Duggan, Stephanie Belson, Jill Knox, Alison McDonald, Charlotte Rawcliffe, Joanne Simon, Tim Sprosen, Jude Watson, Wendy Wood
Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial
Hans M. Nordahl, Joar Øveraas Halvorsen, Odin Hjemdal, Mimoza Rrusta Ternava, Adrian Wells
Photobiomodulation using low-level laser therapy (LLLT) for patients with chronic traumatic brain injury: a randomized controlled trial study protocol
Guilherme da Cruz Ribeiro Poiani, Ana Luiza Zaninotto, Ana Maria Costa Carneiro, Renato Amaro Zangaro, Afonso Shiguemi Inoue Salgado, Rodolfo Borges Parreira, Almir Ferreira de Andrade, Manoel Jacobsen Teixeira, Wellingson Silva Paiva
Commentary: considerations for using the ‘Trials within Cohorts’ design in a clinical trial of an investigational medicinal product
Anna C. Bibby, David J. Torgerson, Samantha Leach, Helen Lewis-White, Nick A. Maskell
Impact of collaborative pharmaceutical care on in-patients’ medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study)
Géraldine Leguelinel-Blache, Christel Castelli, Clarisse Roux-Marson, Sophie Bouvet, Sandrine Andrieu, Philippe Cestac, Rémy Collomp, Paul Landais, Bertrice Loulière, Christelle Mouchoux, Rémi Varin, Benoit Allenet, Pierrick Bedouch, Jean-Marie Kinowski
Combined Cognitive-Behavioural and Physiotherapeutic Therapy for Patients with Chronic Pelvic Pain Syndrome (COMBI-CPPS): study protocol for a controlled feasibility trial
Christian A. Brünahl, Susanne G. R. Klotz, Christoph Dybowski, Björn Riegel, Sonja Gregorzik, Dean A. Tripp, Gesche Ketels, Bernd Löwe
Pregabalin versus gabapentin in the treatment of sciatica: study protocol for a randomised, double-blind, cross-over trial (PAGPROS)
Kelvin Robertson, Laurence A. G. Marshman, Maria Hennessy, Linton Harriss, David Plummer
HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): a randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible: study protocol for a randomised controlled trial
Richard Shaw, Christopher Butterworth, Binyam Tesfaye, Matthew Bickerstaff, Susanna Dodd, Gary Smerdon, Seema Chauhan, Peter Brennan, Keith Webster, James McCaul, Peter Nixon, Anastasios Kanatas, Paul Silcocks
Application of causal inference methods in the analyses of randomised controlled trials: a systematic review
Ruth E. Farmer, Daphne Kounali, A. Sarah Walker, Jelena Savović, Alison Richards, Margaret T. May, Deborah Ford
A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31® in people living in a TB-endemic area
Jemal Hussein, Martha Zewdie, Lawrence Yamuah, Ahmed Bedru, Markos Abebe, Alemnew F. Dagnew, Menberework Chanyalew, Asfawesen G. Yohannes, Jemal Ahmed, Howard Engers, T. Mark Doherty, Peter Bang, Ingrid Kromann, Søren T. Hoff, Abraham Aseffa
Data sharing in clinical trials – practical guidance on anonymising trial datasets
Catriona Keerie, Christopher Tuck, Garry Milne, Sandra Eldridge, Neil Wright, Steff C. Lewis
Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN): Study protocol for a pre-planned observational study
Joerg C. Schefold, Anders Perner, Theis Lange, Jørn Wetterslev, Matt P. Wise, Mark Borthwick, Stepani Bendel, Frederik Keus, Anne Berit Guttormsen, Søren Marker, Mette Krag, Morten Hylander Møller
Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study
David Atallah, Malak Moubarak, Nadine El Kassis, Sara Abboud
Treatment of persistent allergic rhinitis via acupuncture at the sphenopalatine acupoint: a randomized controlled trial
Jiaoping Mi, Xinye Chen, Xiaoyan Lin, Jianling Guo, Hongtao Chen, Liao Wei, Haiyu Hong
Routinely collected data for randomized trials: promises, barriers, and implications
Kimberly A. Mc Cord, Rustam Al-Shahi Salman, Shaun Treweek, Heidi Gardner, Daniel Strech, William Whiteley, John P. A. Ioannidis, Lars G. Hemkens
Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials
Sally Hopewell, Claudia M. Witt, Klaus Linde, Katja Icke, Olubusola Adedire, Shona Kirtley, Douglas G. Altman
Effects of a peer-led Walking In ScHools intervention (the WISH study) on physical activity levels of adolescent girls: a cluster randomised pilot study
Angela Carlin, Marie H. Murphy, Alan Nevill, Alison M. Gallagher
An integrated-delivery-of-care approach to improve patient reported physical function and mental wellbeing after orthopedic trauma: study protocol for a randomized controlled trial
Laura Zdziarski-Horodyski, MaryBeth Horodyski, Kalia K. Sadasivan, Jennifer Hagen, Terrie Vasilopoulos, Matthew Patrick, Robert Guenther, Heather K. Vincent
Mortality impact of an increased blood glucose cut-off level for hypoglycaemia treatment in severely sick children in Malawi (SugarFACT trial): study protocol for a randomised controlled trial
Tim Baker, Queen Dube, Josephine Langton, Helena Hildenwall
Evaluating the long-term impact of the Fostering Changes training programme for foster carers in Wales, the Confidence in Care trial: study protocol for a randomised controlled trial
Gwenllian Moody, Lucy Brookes-Howell, Rebecca Cannings-John, Sue Channon, Elinor Coulman, Mandy Lau, Alyson Rees, Jonathan Scourfield, Jeremy Segrott, Michael Robling
Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial
Andria R. Morielli, Nawaid Usmani, Normand G. Boulé, Diane Severin, Keith Tankel, Tirath Nijjar, Kurian Joseph, Alysa Fairchild, Kerry S. Courneya
Efficacy and safety of combined treatment of miniscalpel acupuncture and non-steroidal anti-inflammatory drugs: an assessor-blinded randomized controlled pilot study
Seungah Jun, Jung Hee Lee, Han Mi Gong, Yeon-Joong Chung, Ju-Ran Kim, Chung A. Park, Seong Hun Choi, Geon-Mok Lee, Hyun-Jong Lee, Jae Soo Kim
SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER): study protocol for a cluster randomised controlled trial
Janet K. Sluggett, Esa Y. H. Chen, Jenni Ilomäki, Megan Corlis, Sarah N. Hilmer, Jan Van Emden, Choon Ean Ooi, Kim-Huong Nguyen, Tracy Comans, Michelle Hogan, Tessa Caporale, Susan Edwards, Lyntara Quirke, Allan Patching, J. Simon Bell
Effect of laparoscopy by single-port endoscopic access in benign adnexal surgery: study protocol for a randomized controlled trial
Andy Schmitt, Patrice Crochet, Karine Baumstark, Claire Tourette, Sabine Poizac, Audrey Pivano, Léon Boubli, Ludovic Cravello, Aubert Agostini
FIT for FUNCTION: study protocol for a randomized controlled trial
Julie Richardson, Ada Tang, Gordon Guyatt, Lehana Thabane, Feng Xie, Demetrios Sahlas, Robert Hart, Rebecca Fleck, Genevieve Hladysh, Louise Macrae
The efficacy of a multimodal physical activity intervention with supervised exercises, health coaching and an activity monitor on physical activity levels of patients with chronic, nonspecific low back pain (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial
Crystian B. Oliveira, Márcia R. Franco, Chris G. Maher, Anne Tiedemann, Fernanda G. Silva, Tatiana M. Damato, Michael K. Nicholas, Diego G. D. Christofaro, Rafael Z. Pinto
Danggwijagyaksan for climacteric syndrome in peri- and postmenopausal women with a blood-deficiency dominant pattern: study protocol for a randomized, double-blind, placebo-controlled pilot trial
Mikyung Kim, Ae-Ran Kim, Hyo-Ju Park, Ojin Kwon, Joo-Hee Kim, Eun-Ji Park, Seon-Eun Baek, Jeong-Eun Yoo, Jun-Hwan Lee
Correction to: Avoidable waste related to inadequate methods and incomplete reporting of interventions: a systematic review of randomized trials performed in Sub-Saharan Africa
Lee Aymar Ndounga Diakou, Francine Ntoumi, Philippe Ravaud, Isabelle Boutron
The Classroom Communication Resource (CCR) intervention to change peer’s attitudes towards children who stutter (CWS): study protocol for a randomised controlled trial
Rizwana Mallick, Harsha Kathard, Lehana Thabane, Mershen Pillay
Pregabalin versus placebo in targeting pro-nociceptive mechanisms to prevent chronic pain after whiplash injury in at-risk individuals – a feasibility study for a randomised controlled trial
J. Nikles, G. Keijzers, G. Mitchell, S. Schug, R. Ware, S. A. McLean, L. Connelly, S. Gibson, S. F. Farrell, M. Sterling
Comparison of modified wet suction technique and dry suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for solid lesions: study protocol for a randomized controlled trial
Yun Wang, Qian Chen, Jinlin Wang, Xiaoli Wu, Yaqi Duan, Ping Yin, Qiaozhen Guo, Wei Hou, Bin Cheng
The Apathy in Dementia Methylphenidate Trial 2 (ADMET 2): study protocol for a randomized controlled trial
Roberta W. Scherer, Lea Drye, Jacobo Mintzer, Krista Lanctôt, Paul Rosenberg, Nathan Herrmann, Prasad Padala, Olga Brawman-Mintzer, William Burke, Suzanne Craft, Alan J. Lerner, Allan Levey, Anton Porsteinsson, Christopher H. van Dyck, Jacobo Mintzer, David Clark, Debra Battjes-Siler, Stan Smith, Courtney O’Neil, Nicole Stocking, Roberta W. Scherer, Lea Drye, Jamie Perin, David Shade, Jennifer Jones, Stephanie Holland, Alicia Wentz, Shumon Chattopadhyay, Bethany Grove, Stephanie Herrera, Kristen Kaiser, Andie Lears, April Broadnax, Aisha Mohammed, Laurie Ryan, Alvin McKelvy, Cerise Elliott, Kenneth Rockwood, Steve Edland, Raymond Scott Turner, Prasad Padala, Debbie Hodges, Nicole Jackson, Kalpana Padala, William Burke, Dawn Batchuluun, Anna Burke, Michele Grigaitis-Reyes, Marjoire DiLise-Russo, Shelia Vadovicky, Susan Favaro, Mary Lou Hernandez, Lynn Autry, Nicole Hoffmann, Rebecca Sanback, Lazaro Martinez Lujan, Elena Young, Alan Lerner, Susie Sami, Marianne Sanders, Parianne Fatica, Maria Gross, Ethan Gore, Supriya Mahajan, Allan Levey, James Lah, Tamara Attis, Janet Cellar, Chad Hales, Margaret Walker, Susan Peterson-Hazan, Erin Bolles, Erin Carter, Paul Rosenberg, Chris Marano, Jasmine Dixon, Sarah Lawrence, Meghan Schulz, Haroon Burhanullah, Anton Porsteinsson, Susan Salem-Spencer, Kim Martin, Audrey Rice, Nancy Kowalski, Michelle Cervello, Melanie Keltz, Kaitlyn Lane, Asa Widman, Olga Brawman-Mintzer, Jacobo Mintzer, Anthony Awkar, Abigail O’Connell, Arthur Williams, Sheila Howland, Alex Hails, Dennis Orwat, Nathan Herrmann, Krista Lanctôt, Abby Li, Damien Gallagher, Adam Dinoff, Danielle Vieira, Jennifer Bray, Eleenor Abraham, Suzanne Craft, Alecia Jenkins, Deborah Dahl, Samantha Rogers, Bonnie Sachs, Emily Mann, Edward Shaw, Kaycee Sink, Erin Caulder, Magie Jefferson, Camilla Martin, Kelsey Shore, Christopher H. van Dyck, Emily Kemp, Hannah Michalak, Melinda Becker, Erika Pugh, Tyler Godek, Martha MacAvoy, Susan Good, Megan Ebner, Julia McDonald, Srinath Ramanan, Adam Mecca, Oliver Lu
Efficacy of pre-operative quadriceps strength training on knee-extensor strength before and shortly following total knee arthroplasty: protocol for a randomized, dose-response trial (The QUADX-1 trial)
Rasmus Skov Husted, Anders Troelsen, Kristian Thorborg, Michael Skovdal Rathleff, Henrik Husted, Thomas Bandholm
Global health trials methodological research agenda: results from a priority setting exercise
Anna Rosala-Hallas, Aneel Bhangu, Jane Blazeby, Louise Bowman, Mike Clarke, Trudie Lang, Mona Nasser, Nandi Siegfried, Karla Soares-Weiser, Matt R. Sydes, Duolao Wang, Junhua Zhang, Paula R. Williamson
The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial
Simone Birnbaum, Jean-Yves Hogrel, Raphael Porcher, Pierre Portero, Bernard Clair, Bruno Eymard, Sophie Demeret, Guillaume Bassez, Marcela Gargiulo, Estelle Louët, Sonia Berrih-Aknin, Asmaa Jobic, Philippe Aegerter, Philippe Thoumie, Tarek Sharshar, Philippe Aegerter, Guillaume Bassez, Sonia Berrih-Aknin, Anthony Behin, Simone Birnbaum, Francis Bolgert, Bernard Clair, Sophie Demeret, Nawal Derridj Ait-Younes, Nabila-Yasmine Domingo, Bruno Eymard, Diane Friedman, Melinee Frenkian, Marcela Gargiulo, Jean-Yves Hogrel, Asmaa Jobic, Pascal Laforet, Isabelle Ledoux, Estelle Louet, Judith Mendelson, Sandra Misdrahi, Cecilia Orblin Bedos, Raphael Porcher, Pierre Portero, Benjamin Rohaut, Tarek Sharshar, Elodie Soler, Philippe Thoumie, Frederique Truffault, Nicolas Weiss, Linda William
Development of a framework to improve the process of recruitment to randomised controlled trials (RCTs): the SEAR (Screened, Eligible, Approached, Randomised) framework
Caroline Wilson, Leila Rooshenas, Sangeetha Paramasivan, Daisy Elliott, Marcus Jepson, Sean Strong, Alison Birtle, David J. Beard, Alison Halliday, Freddie C. Hamdy, Rebecca Lewis, Chris Metcalfe, Chris A. Rogers, Robert C. Stein, Jane M. Blazeby, Jenny L. Donovan
Prevention of severe infectious complications after colorectal surgery using preoperative orally administered antibiotic prophylaxis (PreCaution): study protocol for a randomized controlled trial
Tessa Mulder, Marjolein F. Q. Kluytmans-van den Bergh, Anne Marie G. A. de Smet, Nils E. van ‘t Veer, Daphne Roos, Stavros Nikolakopoulos, Marc J. M. Bonten, Jan A. J. W. Kluytmans, J. A. J. W. Kluytmans, T. Mulder, M. F. Q. Kluytmans-van den Bergh, F. Kloosterman, M. J. M. Bonten, S. Nikolakopoulos, N. E. van ’t Veer, R. M. P. H. Crolla, G. P. van der Schelling, R. J. de Vos tot Nederveen Cappel, J. Veenemans, A. R. M. Brandt, M. Vos, P. M. Verheijen, A. J. L. Weersink, D. Roos, E. van der Vorm, A. Smits, B. Vlaminckx, E. Bathoorn, B. van Etten, A. M. G. A. de Smet
Efficacy of electrical acupuncture on vascular cognitive impairment with no dementia: study protocol for a randomized controlled trial
Tian Li, Huangan Wu, Franscisca Soto-Aguliar, Li Huang, Wentao Li, Lixing Lao, Shifen Xu
Successful recruitment to trials: findings from the SCIMITAR+ Trial
Emily Peckham, Catherine Arundel, Della Bailey, Tracy Callen, Christina Cusack, Suzanne Crosland, Penny Foster, Hannah Herlihy, James Hope, Suzy Ker, Tayla McCloud, Crystal-Bella Romain-Hooper, Alison Stribling, Peter Phiri, Ellen Tait, Simon Gilbody
eRegQual—an electronic health registry with interactive checklists and clinical decision support for improving quality of antenatal care: study protocol for a cluster randomized trial
Mahima Venkateswaran, Kjersti Mørkrid, Buthaina Ghanem, Eatimad Abbas, Itimad Abuward, Mohammad Baniode, Ole Frithjof Norheim, J. Frederik Frøen
Overnight auto-adjusting continuous airway pressure + standard care compared with standard care alone in the prevention of morbidity in sickle cell disease phase II (POMS2b): study protocol for a randomised controlled trial
Jo Howard, April E. Slee, Simon Skene, Baba Inusa, Jamie Kawadler, Michelle Downes, Johanna Gavlak, Melanie Koelbel, Hanne Stotesbury, Maria Chorozoglou, Susan Tebbs, Subarna Chakravorty, Moji Awogbade, David C. Rees, Atul Gupta, Patrick B. Murphy, Nicholas Hart, Sati Sahota, Carol Nwosu, Maureen Gwam, Dawn Saunders, Vivek Muthurangu, Nathaniel Barber, Emmanuel Ako, Swee Lay Thein, Melanie Marshall, Isabel C Reading, Man Ying Edith Cheng, Fenella J. Kirkham, Christina Liossi
Internet-based cognitive behavioural therapy (iCBT) for perinatal anxiety and depression versus treatment as usual: study protocol for two randomised controlled trials
Siobhan A. Loughnan, Jill M. Newby, Hila Haskelberg, Alison Mahoney, Natalie Kladnitski, Jessica Smith, Emma Black, Christopher Holt, Jeannette Milgrom, Marie-Paule Austin, Gavin Andrews
MOVING: Motivation-Oriented interVention study for the elderly IN Greifswald: study protocol for a randomized controlled trial
Fabian Kleinke, Thea Schwaneberg, Franziska Weymar, Peter Penndorf, Sabina Ulbricht, Kristin Lehnert, Marcus Dörr, Wolfgang Hoffmann, Neeltje van den Berg
Relating process evaluation measures to complex intervention outcomes: findings from the PACE-UP primary care pedometer-based walking trial
Cheryl Furness, Emma Howard, Elizabeth Limb, Derek G. Cook, Sally Kerry, Charlotte Wahlich, Christina Victor, Ulf Ekelund, Steve Iliffe, Michael Ussher, Peter Whincup, Julia Fox-Rushby, Judith Ibison, Stephen DeWilde, Tess Harris
Intensity-modulated radiotherapy with integrated-boost in patients with bone metastasis of the spine: study protocol for a randomized controlled trial
Tanja Sprave, Stefan Ezechiel Welte, Thomas Bruckner, Robert Förster, Tilman Bostel, Ingmar Schlampp, Nils Henrik Nicolay, Jürgen Debus, Harald Rief
Evaluation of HbA1c screening during outreach events for prediabetes subject recruitment for clinical research
Sabina Paglialunga, Ryan Bond, Sharon H. Jaycox
Development of a complex intervention for people with chronic pain after knee replacement: the STAR care pathway
Vikki Wylde, Nicholas Howells, Wendy Bertram, Andrew J. Moore, Julie Bruce, Candy McCabe, Ashley W. Blom, Jane Dennis, Amanda Burston, Rachael Gooberman-Hill
The effect of a ketogenic diet versus a high-carbohydrate, low-fat diet on sleep, cognition, thyroid function, and cardiovascular health independent of weight loss: study protocol for a randomized controlled trial
Stella Iacovides, Rebecca M. Meiring
HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial
Kevin Cooper, Kirsty McCormack, Suzanne Breeman, Jessica Wood, Neil W. Scott, Justin Clark, Jed Hawe, Robert Hawthorn, Kevin Phillips, Angela Hyde, Alison McDonald, Mark Forrest, Samantha Wileman, Graham Scotland, John Norrie, Siladitya Bhattacharya, Siladitya Bhattacharya, Kevin Cooper, Kirsty McCormack, Neil Scott, Justin Clark, Jed Hawe, Robert Hawthorne, Kevin Phillips, Angela Hyde, Graham Scotland, John Norrie, Suzanne Breeman, Jessica Wood, Alison McDonald, Mark Forest, Samantha Wileman, Rebecca Bruce, Moira Richie, Fiona Cherry
Evaluation of the Preschool Situational Self-Regulation Toolkit (PRSIST) Program for Supporting children’s early self-regulation development: study protocol for a cluster randomized controlled trial
Steven J. Howard, Elena Vasseleu, Cathrine Neilsen-Hewett, Ken Cliff
A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial
Byung-Cheul Shin, Jae-Heung Cho, In-Hyuk Ha, In Heo, Jun-Hwan Lee, Koh-Woon Kim, Me-riong Kim, So-Young Jung, Ojin Kwon, Nam-Kwen Kim, Haeng-Mi Son, Dong-Wuk Son, Kyung-Min Shin
Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial
Sara T. Brookes, Katy A. Chalmers, Kerry N. L. Avery, Karen Coulman, Jane M. Blazeby, C Paul Barham, Richard Berrisford, Jenny Donovan, Jackie Elliott, Stephen Falk, Robert Goldin, George Hanna, Andrew Hollowood, Sian Noble, Grant Sanders, Tim Wheatley
Harm, benefit and costs associated with low-dose glucocorticoids added to the treatment strategies for rheumatoid arthritis in elderly patients (GLORIA trial): study protocol for a randomised controlled trial
Linda Hartman, Linda A. Rasch, Thomas Klausch, Hans W. J. Bijlsma, Robin Christensen, Yvo M. Smulders, Stuart H. Ralston, Frank Buttgereit, Maurizio Cutolo, Jose A. P. Da Silva, Daniela Opris, Jozef Rovenský, Szilvia Szamosi, Leonie M. Middelink, Willem F. Lems, Maarten Boers
Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa’dom): study protocol for a randomized controlled trial
David Chaparro, Jean-Christophe Daviet, Benoit Borel, Benjamin Kammoun, Jean-Yves Salle, Achille Tchalla, Stéphane Mandigout
The effects of an activity-based lifestyle intervention on moderate sleep complaints among older adults: study protocol for a randomized controlled trial
Doris, S.F. Yu, Shamay S.M. Ng, Diana T.F. Lee, Kai Chow Choi, Parco M.F. Siu, Lisa P.L. Low, Jean Woo
Text4Heart II – improving medication adherence in people with heart disease: a study protocol for a randomized controlled trial
Ralph Maddison, Ralph Stewart, Rob Doughty, Tony Scott, Andrew Kerr, Jocelyne Benatar, Robyn Whittaker, Jonathan C. Rawstorn, Anna Rolleston, Yannan Jiang, Paul Estabrooks, Rachel Karen Sullivan, Hannah Bartley, Leila Pfaeffli Dale
Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial
Luciana G. Langella, Paula F. C. Silva, Larissa Costa-Santos, Marcela L. L. Gonçalves, Lara J. Motta, Alessandro M. Deana, Kristianne P. S. Fernandes, Raquel A. Mesquita-Ferrari, Sandra Kalil Bussadori
Effectiveness and safety of bifidobacteria and berberine in people with hyperglycemia: study protocol for a randomized controlled trial
Jie Ming, Shaoyong Xu, Chun Liu, Xiangyang Liu, Aihua Jia, Qiuhe Ji
A hybrid type I trial to increase Veterans’ access to insomnia care: study protocol for a randomized controlled trial
Adam D. Bramoweth, Anne Germain, Ada O. Youk, Keri L. Rodriguez, Matthew J. Chinman
Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study
Anna M. Johnson, Sara B. Jones, Pamela W. Duncan, Cheryl D. Bushnell, Sylvia W. Coleman, Laurie H. Mettam, Anna M. Kucharska-Newton, Mysha E. Sissine, Wayne D. Rosamond
The effect of targeted exercise on knee-muscle function in patients with persistent hamstring deficiency following ACL reconstruction – study protocol for a randomized controlled trial
Bo Bregenhof, Uffe Jørgensen, Per Aagaard, Nis Nissen, Mark W. Creaby, Jonas Bloch Thorlund, Carsten Jensen, Trine Torfing, Anders Holsgaard-Larsen
‘Recruitment, recruitment, recruitment’ – the need for more focus on retention: a qualitative study of five trials
Anne Daykin, Clare Clement, Carrol Gamble, Anna Kearney, Jane Blazeby, Mike Clarke, J. Athene Lane, Alison Shaw
Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial
Thomas A. Odeny, Maricianah Onono, Kevin Owuor, Anna Helova, Iris Wanga, Elizabeth A. Bukusi, Janet M. Turan, Lisa L. Abuogi
Fair inclusion of pregnant women in clinical trials: an integrated scientific and ethical approach
Rieke van der Graaf, Indira S. E. van der Zande, Hester M. den Ruijter, Martijn A. Oudijk, Johannes J. M. van Delden, Katrien Oude Rengerink, Rolf H. H. Groenwold
Are CONSORT checklists submitted by authors adequately reflecting what information is actually reported in published papers?
David Blanco, Alice M. Biggane, Erik Cobo, Doug Altman, Lorenzo Bertizzolo, Isabelle Boutron, Efstathia Gkioni, Ketevan Glonti, Jamie Kirkham, Camila Olarte, Maria Olsen, Cecilia Superchi
The effectiveness and cost-effectiveness of 3- vs. 6-monthly dispensing of antiretroviral treatment (ART) for stable HIV patients in community ART-refill groups in Zimbabwe: study protocol for a pragmatic, cluster-randomized trial
Geoffrey Fatti, Nicoletta Ngorima-Mabhena, Frank Chirowa, Benson Chirwa, Kudakwashe Takarinda, Taurayi A. Tafuma, Nyikadzino Mahachi, Rudo Chikodzore, Simon Nyadundu, Charles A. Ajayi, Tsitsi Mutasa-Apollo, Owen Mugurungi, Eula Mothibi, Risa M. Hoffman, Ashraf Grimwood
Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial
Yaseen M. Arabi, Adel Alothman, Hanan H. Balkhy, Abdulaziz Al-Dawood, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Abdullah M. Assiri, Fahad Al-Hameed, Asim AlSaedi, Yasser Mandourah, Ghaleb A. Almekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Javed Memon, Yusri Taha, Abdullah Almotairi, Khalid A. Maghrabi, Ismael Qushmaq, Ali Al Bshabshe, Ayman Kharaba, Sarah Shalhoub, Jesna Jose, Robert A. Fowler, Frederick G. Hayden, Mohamed A. Hussein, Yaseen M. Arabi, Adel Alothman, Hanan H Balkhy, Abdulaziz Al-Dawood, Sameera AlJohani, Shmeylan Al Harbi, Suleiman Kojan, Majed Al Jeraisy, Ahmad M. Deeb, Jesna Jose, Mohamed A. Hussein, Mohammed Al Muhaidib, Musharaf Sadat, Hala Al Anizi, Reggie Dael, Abdullah M Assiri, Mohammad AlMazroa, Ayed Asiri, Ziad A Memish, Sameeh S Ghazal, Sarah H Alfaraj, Fahad Bafaqeeh, Abdulrahman Al Harthy, Mohammed Al Sulaiman, Ahmed Mady, Yasser Mandourah, Ghaleb. A. AlMekhlafi, Nisreen Murad Sherbeeni, Fatehi Elnour Elzein, Reema Muhammed, Shatha Al Samirrai, Shatha Awad, Rylen Cabio Cabal, Abdulrauf Ahmad Malibary, Bander Al Onazi, Maha Aljuhani, Melven Vince, Abdullah Almotairi, Mushira Al Enani, Alaa Alqurashi, Fatimah Alenezi, Nada Alkhani, Khalid A. Maghrabi, Fahad Al-Hameed, Asim AlSaedi, Abdulhakeem Thaqafi, Ohoud Al Oraabi, Jalal Rifai, Pansy Elsamadisi, Medhat S. Hendy, Sara AbuBaker Basher, Muhammed Abduldhaher, Wael Bajhamoum, Ismael Qushmaq, Sarah Shalhoub, Yusri Taha, Javed Memon, Shahinaz Bashir, Ibraheem Al-Dossary, Saleh Al Mekhloof, Bader Al-Muhainy, Shehab Suliman, Mohammed S. Alshahrani, Ali Al Bshabshe, Ayman Kharaba, Ahmad Al Jabri, Magdy Farid, Alawi Alaidarous, Wael Alseraihi, Husam Shahada, Jinish Shimi, Syed Riaz, Bader Alharthi, Osama Yasin, Mohammad Khathlan, Robert A. Fowler, Frederick G. Hayden
Effects of automated smartphone mobile recovery support and telephone continuing care in the treatment of alcohol use disorder: study protocol for a randomized controlled trial
James R. McKay, David H. Gustafson, Megan Ivey, Fiona McTavish, Klaren Pe-Romashko, Brenda Curtis, David A. Oslin, Daniel Polsky, Andrew Quanbeck, Kevin G. Lynch
Short-course antimicrobial therapy for paediatric respiratory infections (SAFER): study protocol for a randomized controlled trial
Jeffrey Pernica, Stuart Harman, April Kam, Jacob Bailey, Redjana Carciumaru, Sarah Khan, Martha Fulford, Lehana Thabane, Robert Slinger, Cheryl Main, Marek Smieja, Mark Loeb
Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial
Marjolein A. M. Mulders, Caroline A. Selles, Joost W. Colaris, Rolf W. Peters, Mark van Heijl, Berry I. Cleffken, Niels W. L. Schep
The effect of an intraoperative, lung-protective ventilation strategy in neurosurgical patients undergoing craniotomy: study protocol for a randomized controlled trial
Liyong Zhang, Wei Xiong, Yuming Peng, Wei Zhang, Ruquan Han
Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial
Iain Templeman, Dylan Thompson, Javier Gonzalez, Jean-Philippe Walhin, Sue Reeves, Peter J. Rogers, Jeffrey M. Brunstrom, Leonidas G. Karagounis, Kostas Tsintzas, James A. Betts
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme research funding and UK burden of disease
Fay Chinnery, Gemma Bashevoy, Amanda Blatch-Jones, Lisa Douet, Sarah Puddicombe, James Raftery
The IMPROVE-GAP Trial aiming to improve evidence-based management of community-acquired pneumonia: study protocol for a stepped-wedge randomised controlled trial
Elizabeth H. Skinner, Melanie Lloyd, Edward Janus, May Lea Ong, Amalia Karahalios, Terry P. Haines, Anne-Maree Kelly, Melina Shackell, Harin Karunajeewa
The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary fibrosis with the Addition of Co-trimoxazole (EME-TIPAC): study protocol for a randomised controlled trial
Matthew Hammond, Allan B. Clark, Anthony P. Cahn, Edwin R. Chilvers, William Duncan Fraser, David M. Livermore, Toby M. Maher, Helen Parfrey, Ann Marie Swart, Susan Stirling, David Thickett, Moira Whyte, Andrew Wilson
Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: study protocol for a randomized controlled trial
Ugo Grossi, Natasha Stevens, Eleanor McAlees, Jon Lacy-Colson, Steven Brown, Anthony Dixon, Gian Luca Di Tanna, S. Mark Scott, Christine Norton, Nadine Marlin, James Mason, Charles H. Knowles, Mark Chapman, Andrew Williams, Mark Mercer-Jones, Karen Telford, Andrew Clarke, Sophie Pilkington, Yan Yiannakou, Neil Smart, Douglas Tincello, Andrew Miller, Kenneth Campbell, Neil Cruickshank, Christopher Emmett, David Pares, Emma Horrocks, Paul Vollebregt, Ian Lindsey
Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial
Melanie Schipfer, Carmen Albrecht, Dominic Ehrmann, Thomas Haak, Bernd Kulzer, Norbert Hermanns
A quasi-placebo may have a role in some randomised controlled trials
William P. Whitehouse
Guanxinning tablet for patients who switch from dual antiplatelet therapy to aspirin alone after percutaneous coronary intervention: study protocol for a cluster randomized controlled trial
Jingen Li, Jianqing Ju, Zhuo Chen, Jing Liu, Fang Lu, Rui Gao, Hao Xu
Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial
Sikandar Khan, Ashok Biju, Sophia Wang, Sujuan Gao, Omar Irfan, Amanda Harrawood, Stephanie Martinez, Emily Brewer, Anthony Perkins, Frederick W. Unverzagt, Sue Lasiter, Ben Zarzaur, Omar Rahman, Malaz Boustani, Babar Khan
When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL
Claire L. Vale, William J. Cragg, Ben Cromarty, Bec Hanley, Annabelle South, Richard Stephens, Kate Sturgeon, Mitzy Gafos
Nursing home care educational intervention for family caregivers of older adults post stroke (SHARE): study protocol for a randomised trial
Carolina Baltar Day, Carla Cristiane Becker Kottwitz Bierhals, Naiana Oliveira dos Santos, Duane Mocellin, Mariane Lurdes Predebon, Fernanda Laís Fengler Dal Pizzol, Lisiane Manganelli Girardi Paskulin
Twenty weeks of isometric handgrip home training to lower blood pressure in hypertensive older adults: a study protocol for a randomized controlled trial
Martin Grønbech Jørgensen, Jesper Ryg, Mathias Brix Danielsen, Pascal Madeleine, Stig Andersen
Effect and safety of acupuncture for Hwa-byung, an anger syndrome: a study protocol of a randomized controlled pilot trial
Hye-Yoon Lee, Jung-Eun Kim, Mikyung Kim, Ae-Ran Kim, Hyo-Ju Park, O-Jin Kwon, Jung-Hyo Cho, Sun-Yong Chung, Joo-Hee Kim
Correction to: Meeting abstracts from the 4th International Clinical Trials Methodology Conference (ICTMC) and the 38th Annual Meeting of the Society for Clinical Trials
Steven Penegar, Rebecca Lewis, James Catto, Joanne Cresswell, Leyshon Griffiths, Micki Hill, John Kelly, Allen Knight, John McGrath, Laura Wiley, Hugh Mostafid, Emma Hall
The effectiveness of ICT-based neurocognitive and psychosocial rehabilitation programmes in people with mild dementia and mild cognitive impairment using GRADIOR and ehcoBUTLER: study protocol for a randomised controlled trial
Martina Vanova, Eider Irazoki, J. Antonio García-Casal, Fernando Martínez-Abad, Cristina Botella, Kate R. Shiells, Manuel A. Franco-Martín
Resistant Hypertension On Treatment (ResHypOT): sequential nephron blockade compared to dual blockade of the renin-angiotensin-aldosterone system plus bisoprolol in the treatment of resistant arterial hypertension – study protocol for a randomized controlled trial
Elizabeth do Espirito Santo Cestário, Letícia Aparecida Barufi Fernandes, Luiz Tadeu Giollo-Júnior, Jéssica Rodrigues Roma Uyemura, Camila Suemi Sato Matarucco, Manoel Idelfonso Paz Landim, Luciana Neves Cosenso-Martin, Lúcia Helena Bonalume Tácito, Heitor Moreno Jr., José Fernando Vilela-Martin, Juan Carlos Yugar-Toledo
Effect of Mobile-health on maternal health care service utilization in Eastern Ethiopia: study protocol for a randomized controlled trial
Tilayie Feto Gelano, Nega Assefa, Yadeta Dessie Bacha, Afendi Abdi Mahamed, Kedir Teji Roba, Mitiku Teshome Hambisa
Assessment of clinical effect and treatment quality of immediate-release carvedilol-IR versus SLOW release carvedilol-SR in Heart Failure patients (SLOW-HF): study protocol for a randomized controlled trial
Dong-Ju Choi, Chan Soon Park, Jin Joo Park, Hae-Young Lee, Seok-Min Kang, Byung-Su Yoo, Eun-Seok Jeon, Seok Keun Hong, Joon-Han Shin, Myung-A Kim, Dae-Gyun Park, Eung-Ju Kim, Soon-Jun Hong, Seok Yeon Kim, Jae-Joong Kim
Correction to: Adolescent Coordinated Transition (ACT) to improve health outcomes among young people living with HIV in Nigeria: study protocol for a randomized controlled trial
Nadia A. Sam-Agudu, Jennifer R. Pharr, Tamara Bruno, Chad L. Cross, Llewellyn J. Cornelius, Prosper Okonkwo, Bolanle Oyeledun, Hadiza Khamofu, Ayodotun Olutola, Salome Erekaha, William Nii Ayitey Menson, Echezona E. Ezeanolue
Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial
Kurinchi Gurusamy, Neil Corrigan, Julie Croft, Maureen Twiddy, Stephen Morris, Nick Woodward, Steve Bandula, Daniel Hochhauser, Vicky Napp, Alison Pullan, Nicholas Jakowiw, Raj Prasad, Steven Olde Damink, C. J. H. M. van Laarhoven, Johannes H. W. de Wilt, Julia Brown, Brian R. Davidson
Physical activity as treatment for alcohol use disorders (FitForChange): study protocol for a randomized controlled trial
Mats Hallgren, Victoria Andersson, Örjan Ekblom, Sven Andréasson
The HYSTER study: the effect of intracervically administered terlipressin versus placebo on the number of gaseous emboli and fluid intravasation during hysteroscopic surgery: study protocol for a randomized controlled clinical trial
Lucilla E. Overdijk, Bart M. P. Rademaker, Paul J. M. van Kesteren, Peter de Haan, Robert K. Riezebos, Oscar C. H. Haude
Percutaneous transhepatic vs. endoscopic retrograde biliary drainage for suspected malignant hilar obstruction: study protocol for a randomized controlled trial
Firas Al-Kawas, Harry Aslanian, John Baillie, Filip Banovac, Jonathan M. Buscaglia, James Buxbaum, Amitabh Chak, Bradford Chong, Gregory A. Coté, Peter V. Draganov, Kulwinder Dua, Valerie Durkalski, B. Joseph Elmunzer, Lydia D. Foster, Timothy B. Gardner, Brian S. Geller, Priya Jamidar, Laith H. Jamil, Rajesh N. Keswani, Mouen A. Khashab, Gabriel D. Lang, Ryan Law, David Lichtenstein, Simon K. Lo, Sean McCarthy, Silvio Melo, Daniel Mullady, Jose Nieto, J. Bayne Selby, Vikesh K. Singh, Rebecca L. Spitzer, Brian Strife, Paul Tarnaksy, Jason R. Taylor, Jeffrey Tokar, Andrew Y. Wang, April Williams, Field Willingham, Patrick Yachimski
The impact of manual rotation of the occiput posterior position on spontaneous vaginal delivery rate: study protocol for a randomized clinical trial (RMOS)
C. Verhaeghe, E. Parot-Schinkel, P. E. Bouet, S. Madzou, F. Biquard, P. Gillard, P. Descamps, G. Legendre
Description of complex interventions: analysis of changes in reporting in randomised trials since 2002
Bridget Candy, Victoria Vickerstaff, Louise Jones, Michael King
7 versus 14 days of antibiotic treatment for critically ill patients with bloodstream infection: a pilot randomized clinical trial
Nick Daneman, Asgar H. Rishu, Ruxandra Pinto, Pierre Aslanian, Sean M. Bagshaw, Alex Carignan, Emmanuel Charbonney, Bryan Coburn, Deborah J. Cook, Michael E. Detsky, Peter Dodek, Richard Hall, Anand Kumar, Francois Lamontagne, Francois Lauzier, John C. Marshall, Claudio M. Martin, Lauralyn McIntyre, John Muscedere, Steven Reynolds, Wendy Sligl, Henry T. Stelfox, M. Elizabeth Wilcox, Robert A. Fowler
Feasibility and acceptability of PrE-operative Physical Activity to improve patient outcomes After major cancer surgery: study protocol for a pilot randomised controlled trial (PEPA Trial)
Daniel Steffens, Jane Young, Paula R. Beckenkamp, James Ratcliffe, Freya Rubie, Nabila Ansari, Neil Pillinger, Michael Solomon
Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys
Alice M. Biggane, Lucy Brading, Philippe Ravaud, Bridget Young, Paula R. Williamson
Quality of life, satisfaction and outcomes after ministernotomy versus full sternotomy isolated aortic valve replacement (QUALITY-AVR): study protocol for a randomised controlled trial
Emiliano A. Rodríguez-Caulo, Ana Guijarro-Contreras, Juan Otero-Forero, María José Mataró, Gemma Sánchez-Espín, Arantza Guzón, Carlos Porras, Miguel Such, Antonio Ordóñez, José María Melero-Tejedor, Manuel Jiménez-Navarro
Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach
Rossybelle P. Amorrortu, Mariana Arevalo, Sally W. Vernon, Arch G. Mainous III, Vanessa Diaz, M. Diane McKee, Marvella E. Ford, Barbara C. Tilley
Promoting public access to clinical trial protocols: challenges and recommendations
An-Wen Chan, Asbjørn Hróbjartsson
Catheter Ablation versus Thoracoscopic Surgical Ablation in Long Standing Persistent Atrial Fibrillation (CASA-AF): study protocol for a randomised controlled trial
Habib Rehman Khan, Ines Kralj-Hans, Shouvik Haldar, Toufan Bahrami, Jonathan Clague, Anthony De Souza, Darrel Francis, Wajid Hussain, Julian Jarman, David Gareth Jones, Neeraj Mediratta, Raad Mohiaddin, Tushar Salukhe, Simon Jones, Joanne Lord, Caroline Murphy, Joanna Kelly, Vias Markides, Dhiraj Gupta, Tom Wong
Effectiveness of a transdiagnostic individually tailored Internet-based and mobile-supported intervention for the indicated prevention of depression and anxiety (ICare Prevent) in Dutch college students: study protocol for a randomised controlled trial
Felix Bolinski, Annet Kleiboer, Eirini Karyotaki, Judith E. Bosmans, Anna-Carlotta Zarski, Kiona K. Weisel, David D. Ebert, Corinna Jacobi, Pim Cuijpers, Heleen Riper
Management of medial humeral epicondyle fractures in children: a structured review protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey
Sara L. Dorman, James A. Shelton, Robert Allen Stevenson, Kenneth Linkman, Jamie Kirkham, Daniel C. Perry
A novel integrated care concept (NICC) versus standard care in the treatment of chronic cardiovascular diseases: protocol for the randomized controlled trial CardioCare MV
Christian Schmidt, Alper Öner, Miriam Mann, Katja Krockenberger, Melanie Abbondanzieri, Bernard Brandewiede, Armin Brüge, Gisela Hostenkamp, Axel Kaiser, Henriette Neumeyer, Andreas Ziegler
Recruitment of older adults to three preventative lifestyle improvement studies
Robin Chatters, Louise Newbould, Kirsty Sprange, Daniel Hind, Gail Mountain, Katy Shortland, Lauren Powell, Rebecca Gossage-Worrall, Tim Chater, Anju Keetharuth, Ellen Lee, Bob Woods
Assessing dengue transmission risk and a vector control intervention using entomological and immunological indices in Thailand: study protocol for a cluster-randomized controlled trial
Hans J. Overgaard, Chamsai Pientong, Kesorn Thaewnongiew, Michael J. Bangs, Tipaya Ekalaksananan, Sirinart Aromseree, Thipruethai Phanitchat, Supranee Phanthanawiboon, Benedicte Fustec, Vincent Corbel, Dominique Cerqueira, Neal Alexander
Towards an appropriate framework to facilitate responsible inclusion of pregnant women in drug development programs
Kit C. B. Roes, Indira S. E. van der Zande, Maarten van Smeden, Rieke van der Graaf
Efficacy and safety of Ding-Kun-Dan for female infertility patients with predicted poor ovarian response undergoing in vitro fertilization/intracytoplasmic sperm injection: study protocol for a randomized controlled trial
Saihua Ma, Ruihong Ma, Tian Xia, Masoud Afnan, Xueru Song, Fengqin Xu, Guimin Hao, Fangfang Zhu, Jingpei Han, Zhimei Zhao
The effects of Kinesiotape on acute lateral ankle sprain: study protocol for a randomized controlled trial
Jae-Hong Kim, Myung-Rae Cho, Ju-Hyung Park, Jeong-Cheol Shin, Ji-Hyun Cho, Gwang-Cheon Park, Dongwoo Nam
Reactive community-based self-administered treatment against residual malaria transmission: study protocol for a randomized controlled trial
Joseph Okebe, Joan Muela Ribera, Julie Balen, Fatou Jaiteh, Yoriko Masunaga, Davis Nwakanma, John Bradley, Shunmay Yeung, Koen Peeters Grietens, Umberto D’Alessandro
Prophylactic platelet transfusion prior to central venous catheter placement in patients with thrombocytopenia: study protocol for a randomised controlled trial
Emma K. van de Weerdt, Bart J. Biemond, Sacha S. Zeerleder, Krijn P. van Lienden, Jan M. Binnekade, Alexander P. J. Vlaar, A. van Leent, M. Koeman, P. F. Ypma, M. S. Arbous, A. M. P. Demandt, W. N. K. A. van Mook, J. H. M. Tordoir, E. Wolthuis, J. G. A. M. Blomjous, R. M. Determann, H. Endeman, E. D. Kerver, W. J. F. M. van der Velden, R. Vink, R. P. H. Bokkers, A. B. U. Mäkelburg, W. M. van den Bergh, P. R. Tuinman
A simulation study on estimating biomarker–treatment interaction effects in randomized trials with prognostic variables
Bernhard Haller, Kurt Ulm
Clinical and radiological effect of medialized cortical bone trajectory for lumbar pedicle screw fixation in patients with degenerative lumbar spondylolisthesis: study protocol for a randomized controlled trial (mPACT)
Anja Tschugg, Pujan Kavakebi, Sebastian Hartmann, Sara Lener, Christoph Wipplinger, Wolfgang N. Löscher, Sabrina Neururer, Matthias Wildauer, Claudius Thomé
Controlling Hypertension After Severe Cerebrovascular Event (CHASE): study protocol for a randomized controlled trial
Fang Yuan, Fang Yang, Changhu Xue, Kangjun Wang, Qiuwu Liu, Jun Zhou, Feng Fu, Xiaocheng Wang, Wei Zhang, Yi Liu, Kang Huo, Hua Lv, Wen Jiang
Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial
Lynda Constable, Nikki Cotterill, David Cooper, Cathryn Glazener, Marcus J. Drake, Mark Forrest, Chris Harding, Mary Kilonzo, Graeme MacLennan, Kirsty McCormack, Alison McDonald, Anthony Mundy, John Norrie, Robert Pickard, Craig Ramsay, Rebecca Smith, Samantha Wileman, Paul Abrams
Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial
Vikki Wylde, Wendy Bertram, Andrew D. Beswick, Ashley W. Blom, Julie Bruce, Amanda Burston, Jane Dennis, Kirsty Garfield, Nicholas Howells, Athene Lane, Candy McCabe, Andrew J. Moore, Sian Noble, Tim J. Peters, Andrew Price, Emily Sanderson, Andrew D. Toms, David A. Walsh, Simon White, Rachael Gooberman-Hill
ADJunctive Ulinastatin in Sepsis Treatment in China (ADJUST study): study protocol for a randomized controlled trial
Wei Jiang, Xiangyou Yu, Tongwen Sun, Yanfen Chai, Ping Chang, Zhongqing Chen, Jingye Pan, Zhiyong Peng, Ruilan Wang, Xiaozhi Wang, Yuan Xu, Li Yu, Qingshan Zheng, Bin Du
Quality of reporting of outcomes in phase III studies of pulmonary tuberculosis: a systematic review
Laura Jayne Bonnett, Gie Ken-Dror, Geraint Rhys Davies
Recovery of muscle function after deep neuromuscular block by means of diaphragm ultrasonography and adductor of pollicis acceleromyography with comparison of neostigmine vs. sugammadex as reversal drugs: study protocol for a randomized controlled trial
Iacopo Cappellini, Fabio Picciafuochi, Daniele Ostento, Ginevra Danti, Angelo Raffaele De Gaudio, Chiara Adembri
Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial
Sarah Baos, Amberly Brigden, Emma Anderson, William Hollingworth, Simon Price, Nicola Mills, Lucy Beasant, Daisy Gaunt, Kirsty Garfield, Chris Metcalfe, Roxanne Parslow, Harriet Downing, David Kessler, John Macleod, Paul Stallard, Hans Knoop, Elise Van de Putte, Sanne Nijhof, Gijs Bleijenberg, Esther Crawley
Controlled Education of patients after Stroke (CEOPS)- nurse-led multimodal and long-term interventional program involving a patient’s caregiver to optimize secondary prevention of stroke: study protocol for a randomized controlled trial
Anne-Marie Mendyk, Alain Duhamel, Yannick Bejot, Didier Leys, Laurent Derex, Olivier Dereeper, Olivier Detante, Pierre-Yves Garcia, Olivier Godefroy, Francisco Macian Montoro, Jean-Philippe Neau, Sébastien Richard, Thierry Rosolacci, Igor Sibon, Denis Sablot, Serge Timsit, Mathieu Zuber, Charlotte Cordonnier, Régis Bordet, S. Canaple, A. Arnoux, M. Barbey, C. Lamy, S. Blin, L. Lilan, N. Heyvang, F. Leroux, N. Gouvenec, F. Couadou, B. Lemaire, E. Manier, C. Perez, J. C. Seghezzi, H. Soret, M. Giroud, N. Mielle, M. Bodenant, D. Deplanque, N. Dequatre, H. Hénon, F. Lebeau, Christine Peré, B. Pommet, J. Teypaz, N. Desfarges, A. Setnikar, O. Deporter, S. Monvoisin, S. Godaux, A. Chatelain, B. Touati, A. Bonnetain, E. Gimenez, J. Joule, M. Karl, S. Mesnildrey, A. Lahanque
Phase-based treatment versus immediate trauma-focused treatment in patients with childhood trauma-related posttraumatic stress disorder: study protocol for a randomized controlled trial
Noortje I. van Vliet, Rafaele J. C. Huntjens, Maarten K. van Dijk, Ad de Jongh
Trial Forge Guidance 1: what is a Study Within A Trial (SWAT)?
Shaun Treweek, Simon Bevan, Peter Bower, Marion Campbell, Jacquie Christie, Mike Clarke, Clive Collett, Seonaidh Cotton, Declan Devane, Adel El Feky, Ella Flemyng, Sandra Galvin, Heidi Gardner, Katie Gillies, Jan Jansen, Roberta Littleford, Adwoa Parker, Craig Ramsay, Lynne Restrup, Frank Sullivan, David Torgerson, Liz Tremain, Matthew Westmore, Paula R. Williamson
Bright light therapy versus physical exercise to prevent co-morbid depression and obesity in adolescents and young adults with attention-deficit / hyperactivity disorder: study protocol for a randomized controlled trial
Jutta S. Mayer, Katharina Hees, Juliane Medda, Oliver Grimm, Philip Asherson, Mariano Bellina, Michael Colla, Pol Ibáñez, Elena Koch, Antonio Martinez-Nicolas, Adrià Muntaner-Mas, Anna Rommel, Nanda Rommelse, Saskia de Ruiter, Ulrich W. Ebner-Priemer, Meinhard Kieser, Francisco B. Ortega, Johannes Thome, Jan K. Buitelaar, Jonna Kuntsi, J. Antoni Ramos-Quiroga, Andreas Reif, Christine M. Freitag
EEPIC - Enhancing Employability through Positive Interventions for improving Career potential: the impact of a high support career guidance intervention on the wellbeing, hopefulness, self-efficacy and employability of the long-term unemployed - a study protocol for a randomised controlled trial
Nuala Whelan, Sinéad McGilloway, Mary P. Murphy, Colm McGuinness
Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial (PRIDe): a phase IV multicenter, randomized, placebo-controlled, double-blind clinical trial of ketamine versus haloperidol for prevention of postoperative delirium
Harriet Riegger, Alexa Hollinger, Burkhardt Seifert, Katharina Toft, Andrea Blum, Tatjana Zehnder, Martin Siegemund
Antifibrotic and molecular aspects of rifaximin in alcoholic liver disease: study protocol for a randomized controlled trial
Bjørn Stæhr Madsen, Jonel Trebicka, Maja Thiele, Mads Israelsen, Manimozhiyan Arumugan, Troels Havelund, Aleksander Krag
Efficacy of high-intensity, low-volume interval training compared to continuous aerobic training on insulin resistance, skeletal muscle structure and function in adults with metabolic syndrome: study protocol for a randomized controlled clinical trial (Intraining-MET)
Jaime Gallo-Villegas, Juan Carlos Aristizabal, Mauricio Estrada, Luis H. Valbuena, Raul Narvaez-Sanchez, Jorge Osorio, Daniel C. Aguirre-Acevedo, Juan C. Calderón
Improving pain treatment with a smartphone app: study protocol for a randomized controlled trial
Carlos Suso-Ribera, Ángela Mesas, Javier Medel, Anna Server, Esther Márquez, Diana Castilla, Irene Zaragozá, Azucena García-Palacios
Xiangbin prescription for the recovery of gastrointestinal function after abdominal surgery (the XBPRS trial): study protocol for a randomized controlled trial
Huachan Gan, Jinxuan Lin, Zhi Jiang, Qicheng Chen, Lixing Cao, Zhiqiang Chen
Identifying trial recruitment uncertainties using a James Lind Alliance Priority Setting Partnership – the PRioRiTy (Prioritising Recruitment in Randomised Trials) study
Patricia Healy, Sandra Galvin, Paula R. Williamson, Shaun Treweek, Caroline Whiting, Beccy Maeso, Christopher Bray, Peter Brocklehurst, Mary Clarke Moloney, Abdel Douiri, Carrol Gamble, Heidi R. Gardner, Derick Mitchell, Derek Stewart, Joan Jordan, Martin O’Donnell, Mike Clarke, Sue H. Pavitt, Eleanor Woodford Guegan, Amanda Blatch-Jones, Valerie Smith, Hannah Reay, Declan Devane
Therapeutic and pharmaco-biological, dose-ranging multicentre trial to determine the optimal dose of TRAnexamic acid to reduce blood loss in haemorrhagic CESarean delivery (TRACES): study protocol for a randomised, double-blind, placebo-controlled trial
Anne-Sophie Bouthors, Benjamin Hennart, Emmanuelle Jeanpierre, Anne-Sophie Baptiste, Imen Saidi, Elodie Simon, Damien Lannoy, Alain Duhamel, Delphine Allorge, Sophie Susen
TRAnexamic acid in hemorrhagic CESarean section (TRACES) randomized placebo controlled dose-ranging pharmacobiological ancillary trial: study protocol for a randomized controlled trial
Anne-Sophie Ducloy-Bouthors, Emmanuelle Jeanpierre, Imen Saidi, Anne-Sophie Baptiste, Elodie Simon, Damien Lannoy, Alain Duhamel, Delphine Allorge, Sophie Susen, Benjamin Hennart
Effect of an exercise-based cardiac rehabilitation program “Baduanjin Eight-Silken-Movements with self-efficacy building” for heart failure (BESMILE-HF study): study protocol for a randomized controlled trial
Xiankun Chen, Wei Jiang, Xiaoli Lin, Cecilia Stålsby Lundborg, Zehuai Wen, Weihui Lu, Gaetano Marrone
The effect of a six-week osteopathic visceral manipulation in patients with non-specific chronic low back pain and functional constipation: study protocol for a randomized controlled trial
Walkyria Vilas Boas Fernandes, Cleofás Rodríguez Blanco, Fabiano Politti, Fernanda de Cordoba Lanza, Paulo Roberto Garcia Lucareli, João Carlos Ferrari Corrêa
Efficacy and safety of electroacupuncture for post stroke depression: study protocol for a randomized controlled trial
Wa Cai, Wen Ma, Guan-Tao Wang, Wei-Dong Shen
CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial
Natalie Hutchings, Wendy Wood, Isabel Reading, Erin Walker, Jane M. Blazeby, William van’t Hoff, Bridget Young, Esther M. Crawley, Simon Eaton, Maria Chorozoglou, Frances C. Sherratt, Lucy Beasant, Harriet Corbett, Michael P. Stanton, Simon Grist, Elizabeth Dixon, Nigel J. Hall
The Strengthening Exercises in Shoulder Impingement trial (The SExSI-trial) investigating the effectiveness of a simple add-on shoulder strengthening exercise programme in patients with long-lasting subacromial impingement syndrome: Study protocol for a pragmatic, assessor blinded, parallel-group, randomised, controlled trial
Mikkel Bek Clausen, Thomas Bandholm, Michael Skovdal Rathleff, Karl Bang Christensen, Mette Kreutzfeldt Zebis, Thomas Graven-Nielsen, Per Hölmich, Kristian Thorborg
Mesenchymal stem cells in the treatment of Cesarean section skin scars: study protocol for a randomized, controlled trial
Dazhi Fan, Qing Xia, Shuzhen Wu, Shaoxin Ye, Li Liu, Wen Wang, Xiaoling Guo, Zhengping Liu
Effects of combined high-intensity aerobic interval training program and Mediterranean diet recommendations after myocardial infarction (INTERFARCT Project): study protocol for a randomized controlled trial
Sara Maldonado-Martín, Jon Ander Jayo-Montoya, Tatiana Matajira-Chia, Beatriz Villar-Zabala, Juan José Goiriena, G. Rodrigo Aispuru
High-flow nasal oxygen vs. standard oxygen therapy in immunocompromised patients with acute respiratory failure: study protocol for a randomized controlled trial
Elie Azoulay, Virginie Lemiale, Djamel Mokart, Saad Nseir, Laurent Argaud, Frédéric Pène, Loay Kontar, Fabrice Bruneel, Kada Klouche, François Barbier, Jean Reignier, Anabelle Stoclin, Guillaume Louis, Jean-Michel Constantin, Julien Mayaux, Florent Wallet, Achille Kouatchet, Vincent Peigne, Pierre Perez, Christophe Girault, Samir Jaber, Johanna Oziel, Martine Nyunga, Nicolas Terzi, Lila Bouadma, Christine Lebert, Alexandre Lautrette, Naike Bigé, Jean-Herlé Raphalen, Laurent Papazian, Antoine Rabbat, Michael Darmon, Sylvie Chevret, Alexandre Demoule
Improved adherence adjustment in the Coronary Drug Project
Eleanor J. Murray, Miguel A. Hernán
Efficacy and safety of electrical moxibustion for knee osteoarthritis: study protocol for a randomized controlled trial
Ha-Ra Kang, Chan-Yung Jung, Seung-Deok Lee, Kyung-Ho Kim, Kap-Sung Kim, Eun-Jung Kim
Laparoscopic inguinal ligament suspension versus laparoscopic sacrocolpopexy in the treatment of pelvic organ prolapse: study protocol for a randomized controlled trial
Chunbo Li, Zhiyuan Dai, Huimin Shu
BetaMe: impact of a comprehensive digital health programme on HbA1c and weight at 12 months for people with diabetes and pre-diabetes: study protocol for a randomised controlled trial
Diana Sarfati, Melissa McLeod, James Stanley, Virginia Signal, Jeannine Stairmand, Jeremy Krebs, Anthony Dowell, William Leung, Cheryl Davies, Rebecca Grainger
The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial
Rustam Al-Shahi Salman, Martin S. Dennis, Gordon D. Murray, Karen Innes, Jonathan Drever, Lynn Dinsmore, Carol Williams, Philip M. White, William N. Whiteley, Peter A. G. Sandercock, Cathie L. M. Sudlow, David E. Newby, Nikola Sprigg, David J. Werring, Martin Dennis, Cathie Sudlow, William Whiteley, Christine Lerpiniere, Katrina McCormick, Jack Perry, Rustam Al-Shahi Salman, Ruwan Parakramawansha, Neil Hunter, Fergus Doubal, Ruth Paulton, Richard OBrien, Christine Lerpiniere, Seona Burgess, Gillian Mead, Pat Taylor, Mary-Joan MacLeod, Beverly Maclennan, Rebecca Clarke, Vicky Taylor, Katrina Klaasen, Nichola Crouch, Baljit Jagpal, Jacqueline Furnace, Janice Irvine, Heather Gow, Anu Joyson, Sandra Nelson, Sarah Ross, Ruth Davies, Deepa Jose, Naomi Robinson, Laura Codd, Angela Dodd, Helen Moroney, Pauline Weir, Victoria Little, Valerie Gott, Graeme Sangster, Paula Owings, Suja Cherian, Susan Downham, Daniel Epstein, Adam Webber, Sammie Qureshi, Paul Nicholas, Vinodh Krishnamurthy, Avani Shukla, Ifan Jones, Ashraf Ahmed, Mishell Cunningham, Tajammal Zahoor, Sharon Johnson, Carol Denniss, Mo Albazzaz, Hawraman Ramadan, Stuart Maguire, Chris Patterson, Ruth Bellfield, Brigid Hairsine, Outi Quinn, Michaela Hooley, Anand Nair, Mohammad Irfan Alam, Jill Greig, Pratap Rana, Matthew Robinson, Mahmud Sajid, Margaret Ball, Rachel Gascoyne, George Ghaly, Senthil Raghunathan, Judith Clarke, Gwendoline Wilkes, Zhe Law, Jason Appleton, Oliver Matias, Benjamin Jackson, Rekha Keshvara, Katherine Whittamore, Carla Jordan, Saima Sheikh, Jack Roffe, Nicola Gilzeane, Kailash Krishnan, Amanda Buck, Diane Havard, Amanda Hedstrom, Faye Shelton, Nikola Sprigg, Margi Godfrey, Timothy Webster, Syed Haider, Samantha Seagrave, Sandra Leason, Arumugam Nallasivan, Kausic Chatterjee, Charlotte Perkins, Azlisham Mohd Nor, Nicola Persad, Charlotte Eglinton, Claire Brown, Marie Weinling, Alex Shah, John Baker, Benjamin Hyams, Manohar Kini, Rosanna Fong, Dinesh Chadha, Deborah Walstow, Harald Proeschel, Simon Sharpe, Sarah Horton, Stephanie Jones, Anthony Byrne, Caroline McGhee, Amanda Smart, Claire Copeland, Dipankar Dutta, Rehana Bakawala, Susan O’Connell, Chloe Hughes, Pauline Brown, Fiona Davis, Kayleigh Collins, Deborah Ward, Jennifer Turfrey, Tony Rudd, Katherine Marks, Sagal Kullane, Birns Jonathan, Ajay Bhalla, Brigitte Yip, Murdina Bell, Brian MacInnes, Linda Macliver, Derek Esson, Rajendra Yadava, Samantha Stafford, Julie Reddan, Mirriam Sangombe, Khalid Azhar, Colin Jenkins, Fiona Price, Claire Hughes, Lily Mercer, Evangelos Vasileiadis, Cathy Mason, Basaam Aweid, Melinda Holden, Anthea Parry, Geraldine Landers, David Broughton, Kath Chapman, Andrew Sigsworth, Dinesh Tryambake, Andrew Young, Lynn Dixon, Adrian Bergin, Mark Barber, Derek Esson, Fiona Brodie, Talat Anjum, Lynda Connor, Susan Tucker, Sarah Thomas, Caroline Davies, Peter Slade, Shelley Treadwell, Mushtaq Wani, Teresa Beaty, Manju Krishnan, Lynne Dacey, Jayne Spencer, Leanne Quinn, Srikanth Chenna, Sharon Storton, Terry Jones, Helen Thompson Jones, Malik Hussain, Jane Homan, Eliza Foster, Lucy Brotherton, Helen Durman, Nicholas Hunt, Jayne Foot, Alison Whitcher, Corinne Pawley, Mohammad Khan, Robert Whiting, Miriam Harvey, Sarah Brown, Leanne Foote, Bella Richard, Claire Triscott, Mandy Edwards, Heidi Lawson, Rebecca Wallace, Claire Nott, Sally Moseley, Steve Buckle, Procter Sarah, Jessica Whiteman, Ken Fotherby, Donna Butler, Angela Willberry, Nasar Ahmad, Karla Jennings-Preece, Farrukh Baig, Debbie Morgan, Angela Stevens, Kneale Metcalf, Susan McDonald, Garth Ravenhill, Ajmal Anversha, Naval Shinh, Rebekah Perfitt, Richard Greenwood, Janak Saada, Kelly Waterfield, Patrick Sutton, Jenny Jagger, Alison Wiltshire, Robert Luder, Venetia Vettimootal Johnson, Hayley Bridger, Maneesh Bhargava, Jill Gallagher, Tolu Adesina, Chloe van Someren, Michael Carpenter, Marion Walker, Andrew Stanners, Julie Ball, Linda Jackson, Prabal Datta, Gavin Bateman, Razik Fathima, Richard Davey, Ann Needle, Prasad Siddegowda, Suheil Ponnambath, Anne Suttling, Yasmin Harrington-Davies, Rebecca Butler, Claire James, Stacey Valentine, Tracey Dobson, Peter Howard, Jane Tandy, Lisa Hyatt, David Jarrett, Afaq Saulat, Don Sims, Mark Willmot, Carole Green, Rachael Jones, James Cunningham, Susan Maiden, Claire Sutton, Jennifer Hurley, Edward Littleton, Raj Shekhar, Rachel Crown, Iman Ahmed, Sister Tracy Fuller, Ellie Gilham, Kelly Waterfield, Sreeman Andole, Naveen Gadapa, Karen Dunne, Magdalini Krommyda, Evelyne Burssens, Sam King, Neetish Goorah, Angela Bell, Farzana Patel, Benjamin Tomlinson, Stephen Duberley, Arun Singh, Christine Kelly, Jamie Walford, Frances Harrington, Christine Schofield, Linda Lucas, Sam Ellis, Kirsty Bond, Abhijit Mate, Katja Adie, Ali James, Bev Maund, Gillian Courtauld, Paul Mudd, Anthony Hemsley, Kevin Thorpe, Karin Gupwell, Anita Goff, Jane Sword, Caroline Roughan, David Strain, Julie Cageao, Angela Bowring, Samantha Keenan, Martin James, Hayley Kingwell, Keniesha Miller, Kirsty Harkness, Clare Doyle, Arshad Majis, Kathy Stocks, Ahmad Maatouk, Luke Barron, Katy Dakin, Ralf Lindert, Christine Kamara, Pauline Bayliss, Jessica Redgrave, Faith Kibutu, Catrin Blank, Ali Ali, Olesia Balitska, Kathryn Birchall, Emma Richards, Jo Howe, Nigel Smyth, Elio Giallombardo, Charlotte Eglinton, Lucy Sykes, Jenny Wilson, Peter Langhorne, Christine McAlpine, Louise Humphreys, Mohammad Shahzad Iqbal, Ruth Graham, Gillian Kerr, Fiona Wright, Pradeep Kumar, Philip Thomas, Charlotte Culmsee, Isabel Huggett, Linda Dunn, James Barker, Aravind Manoj, Paul Fitzsimmons, Paula Lopez, Nikhil Sharma, Penelope Cox, Glyn Fletcher, Mark Wilkinson, Hedley Emsley, Sonia Raj, Donna Doyle, Bindu Gregory, Shuja Punekar, Sulaiman Sultan, Alison McLoughlin, Kath Pasco, Olga Balazikova, Ashraf Nasim, Cassilda Peixoto, Ingrid Kane, Alexandra Pitt-Ford, Simon Hervey, Philip Thompson, Laura Latter, Emma Barbon, Joanna Breeds, Chakravarthi Rajkumar, Nicola Gainsborough, Jane Gaylard, James Choulerton, Louise Shaw, Barbara Madigan, Deborah Howcroft, Suzanne Lucas, Andrew Stone, Joanne Avis, Lukuman Gbadamoshi, Denise Button, Mc Cann Stephanie, Lindsey Dow, Michelle Davis, Teresa Thompson, Valerie Hogg, Carole Hays, Michelle Fawcett, Natalie Atkinson, Helen Guy, Stephen Woodward, Adrian Parry-Jones, Sally Marshall, Rowilson Jarapa, Stephanie Lee, Louise Harrison, Mary Johnes, Victoria Oloughlin, Edith Wood, Jane Perez, Zin Naing, Jordi Morell, Tracy Marsden, Andrea Ingham, Ilse Burger, Kelly Marie Shaw, Andrea Hall, Martin Punter, Nic Weir, Sue Evans, Ashleigh Walters, Imogen Gartrell, Fiona Smith, Chloe Cox, Charge Nurse Simon Smith, Shuna Egerton, Robyn Creeden, James Richard Marigold, Alex Blades, Pam Crawford, Lucy Sykes, Emma Battersby-Wood, Vanessa Pressly, Christopher Allen, Gabriella Howard, Keith Muir, Dheeraj Kalladka, Wilma Smith, Nicola Day, Fiona Moreton, Bharath Kumar Cheripelli, Xuya Huang, Angela Welch, Salwa El Tawil, Sankaranarayanan Ramachandran, Caroline Crosbie, Jennifer Elliot, Gillian Cluckie, Brian Clarke, Nilofer Dayal, Chukwuka Orefo, Temi Adedoyin, Rita Ghatala, Natasha Clarke, Val Jones, Adrian Blight, Caroline Lovelock, Neha Chopra, Barry Moynihan, Kate Kennedy, Rebecca Williams, Lourda Kerin, Naomi Jeyaraj, Lillian Choy, Fran Watson, Sarah Trippier, Joanna OReill, Mohammad Haque, Stuart Symonds, Mehran Maanoosi, Jane Herman, Joseph Vassallo, Shrivakumar Krishnamoorthy, Helen Cochrane, Deborah Walter, Janice OConnell, Charlotte Fox, Ramesh Krishnamurthy, Emily Osborne, Andrew Smith, Betty Mokoena, Diane Gulliver, Helen Brew, Min Myint, Nikhil Majmudar, George Bunea, Naweed Sattar, Meena Srinivasan, Indranil Mukherjee, Nichola Motherwell, Denise Donaldson, Robert Campbell, Frances Hurford, Kamy Thavanesan, Owen David, Divya Tiwari, Gail Hann, Barbara Longland, Jo Bell, Emily Rogers, Caroline Bagnall, Arshi Iqbal, Marketa Keltos, Becky Jupp, Josh Roberts, Chantel Cox, Catherine Ovington, Biju Bhaskaran, Joanne Garfield-Smith, Jean Buxton, Kathleen Horan, Afaq Saulat, Georgina Ayres, Helen Bearne, Dawn Tomlin, Susan Szabo, Debs Kelly, Isam Salih, Harbens Bhakri, Pauline Fitzell, David Wilson, Belinda Wroath, Kevin Dynan, Michael Power, Susan Thompson, Sandip Ghosh, Margo Henry, Danielle Gilmour, Elizabeth Barrie, Antony Kenton, Sheila Nyabadza, Irene Martin, Benjamin Hunt, Hardi Hassan, Bander Dallol, Girish Muddegowda, Joanne Hiden, Holly Maguire, Jeanette Grocott, Kay Finney, Adrian Barry, Christine Roffe, Sue Lyjko, Ranjan Sanyal, Alda Remegoso, Phillip Ferdinand, Adrian Butler, Nenette Abano, Chelsea Causley, Hayley Denic, Racquel Carpio, Stephanie Stevens, Andrew Moores, Resti Varquez, Yogish Pai, David Bruce, Sofia Dima, Vidya Baliga, Muhammad Naeem, Gill Rogers, Ellen Brown, Rachel Hayman, Mark Garside, Mahesh Dhakal, Gemma Marie Smith, Susan Clayton, Enoch Orugun, Una Poultney, Rachel Glover, Hannah Crowther, Sarah Thornthwaite, Tom Webb, Eva Beranova, Susannah Walker, Tracey Cosier, Hannah Rudenko, Linda Cowie, Anna Verrion, Audrey Thomson, Ed Gamble, Bethan Charles, Rebecca Grue, Sujata Blane, Adam Hague, Khalid Rashed, Carinna Vickers, Diane Wood, Janne Board, Clare Buckley, Joanna Allison, Sarah Board, Barbara William-Yesson, Linda Balian, Elizabeth Keeling, Arindam Kar, Omid Halse, Vinh Nguyen, Kirsten Harvey, Léjeune Gardener, Sheila Mashate, Victoria Tilley, Peter Wilding, Olivia Geraghty, Beth Hazel, Thomas Harrison, Larissa Cuenoud, Grace Auld, Esther Erumere, Ozlem Redjep, Gemma Grimwood, Laura Howaniec, Dionne Hove, Afraim Salek-Haddadi, Kari Saastamoinen, Lucia Argandona, Ivan Wiggam, Aine Wallace, Sarah Cuddy, Suzanne Tauro, Annemarie Hunter, Enda Kerr, Ailsa Fulton, Janet Putterill, Puneet Kakar, Ratneshwari Jha, Rachel Gallifent, Aparna Pusalkar, Kelly Chan, Puneet Dangri, Karen Crabtree, Hannah Beadle, Angela Cook, Toby Black, Julie Cronin, Ruth Fennelly, Michele Tribbeck, Caroline Clarke, Skelton Miriam, Alpha Anthony, Denise Mead, Bernard Esisi, Maria Bokhari, Tim Cassidy, Beverley McClelland, Martin Cooper, Inez Wynter, Anoja Rajapakse, Mohammad Nasar, Ijaz Anwar, Lynn Dixon, Alex Ramshaw, Arunkumar Annamalai, Susan Crawford, Tarn Nozedar, Helen Skinner, Balakrishna Kumar, Damian McArdle, Clare Holmes, Emily Dodd, Samantha Clarke, Sarah Caine, Pauline Baker, Peter Murphy, Mairead Osborn, Lucy Belle Guthrie, Amy Steele, Nicola Devitt, David Mangion, Jo Fletecher, Anne Hardwick, Carmen Constantin, Skarlet Markova, Tara Lawrence, Santhosh Subramonian, Natalie Temple, Peter Owusu-Agyei, Nicola Butterworth-Cowin, David Werring, Caroline Hogan, Maria Brezitski, Emma Elliott, Nina Francia, Amy Ashton, Isabel Hostettler, Nnebuife Oji, Azra Banaras, Krishna Patel, Luci Crook, Caroline Watchurst, Duncan Wilson, Ifan Jones, Renuka Erande, Lakshmanan Sekaran, Niaz Mohammed, Meena Chauhan, Sakthivel Sethuraman, Rohan Simon, Kiranjit Bharaj, Margaret Tate, Frances Justin, Duke Phiri, Jonathan Hewitt, Claire Nott, Jane Gray, Rebecca Wallace, Rina Mardania, Claire Triscott, Sarah Procter, Steve Buckle, Jessica Whiteman, Khaled Elfandi, Julie Reddan, Uzma Khan, Samantha Stafford, Suzanne Ragab, Kerstin Knops, Emma Jinks, Christine Dickson, Laura Gleave, Jacqui Leggett, Judith Dube, Tatiana Garcia, James McIlmoyle, Sajjad Anwar, Saikat Dhar, Kirsty Jones, Carol Jeffs, Christina Dickinson, Joanne Howard, Timothy England, Richard Donnelly, Amanda Hedstrom, Mohana Maddula, Ahamad Hassan, Emelda Veraque, Mary Kambafwile, Linetty Makawa, Marc Randall, Vasileios Papavasileiou, Dean Waugh, Sissy Ispoglou, Anne Hayes, Sandeep Ankolekar, Rachel Evans, Hlaing Ni, Carol Graham, Josin Jose, Josette Milligan, Bithi Rahman, Paul Findlay, Ashish Macaden, Ian Shread, Breffni Keegan, Caroline Blair, Jim Kelly, Mandy Doherty, Richard Dewar, James White, Kelly Thomas, David Cohen, Anette David, Emmanuelle Owoyele, Kelechi Njoku, Philip Poku, Varthi Sukdeo, Aberami Chandrakumar, Angela Chamberlain, Mudhar Abbdul-saheb, Fenglin Guo, Anne Oshodi, Radim Licenik, Joseph Devine, Silvie Davies, Nabeela Nisar, Rangah Niranchanan, Tatjana Roganova, Mushiya Mpelembue, Laura Burgess, Rajaram Bathula, Mmua Ngwako, David Eveson, Amit Mistri, Claire Stephens, Kashif Musarrat, Man Yee Lam, Saira Sattar, Shagufta Khan, Mohammed Moqsith, Lisa Manning, Champa Patel, Ursula Schulz, James Kennedy, Gary Ford, George Harston, Rachel Teal, Philip Mathieson, Giulia Lenti, Ian Reckless, Claire Cullen, Sarah Stevenson, Melanie Harrison, Jordan Ewing, Daniela Shackcloth, Ramesh Durairaj, Mellor Zoe, Tanya Ingram, Hlaing Thant, Jenny Peters, Victoria Sutton, Simone Ivatts, Isobel Amey, Lisa Clayton-Evans, Yolanda Baird, Moore Sally, Sophie Newton, Paul Guyler, Kheng Xiong Ng, Rajalakshmi Orath Prabakaran, David Ngo, Sindhu Rashmi, Lucy Coward, Nisha Menon, Shyam Kelavkar, Swapna Kunhunny, Devesh Sinha, Anwer Siddiqui, Amber Siddiqui, Thayalini Loganathan, Sharon Tysoe, Sweni Shah, Latheef Kalathil, Nikki Gautam, Julie Meir, Duncan Bailey, Maqsud Salehin, Richard Miller, Amor Kelly, Rayessa Rayessa, Alicia Rodgers, Lisa Wilson, Charde Naylor, Sarah Wilson, Emma Clarkson, Mark McCarron, Ferghal McVerry, Caroline Blair, Jacqueline McKee, Mandy Doherty, Vera Cvoro, Khalil Ullah, Nicola Chapman, Mandy Couser, Katrina McCormick, Sean Mcauley, Susan Pound, Anne Nicolson, Javed Imam, Julie White, Lisa Wood, Eoin OBrien, Niamh Hannon, Sarah Finlay, Helen Hayhoe, Dominic Handley, Siobhan Kelly, Joanne Mcgee, Jennifer Mitchell, Elaine Amis, Juliana Sesay, Sarah Crisp, Jobbin Francis
Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations
Mary Sawtell, Lorna Sweeney, Meg Wiggins, Cathryn Salisbury, Sandra Eldridge, Lauren Greenberg, Rachael Hunter, Inderjeet Kaur, Christine McCourt, Bethan Hatherall, Gail Findlay, Joanne Morris, Sandra Reading, Adrian Renton, Ruth Adekoya, Belinda Green, Belinda Harvey, Sarah Latham, Kanta Patel, Logan Vanlessen, Angela Harden
Correction to: Metacognitive therapy vs. eye movement desensitization and reprocessing for posttraumatic stress disorder: study protocol for a randomized superiority trial
Hans M. Nordahl, Joar Øveraas Halvorsen, Odin Hjemdal, Mimoza Rrusta Ternava, Adrian Wells
Comparative Efficacy and Mechanisms of a Single-Session Pain Psychology Class in Chronic Low Back Pain: Study Protocol for a Randomized Controlled Trial
Beth D. Darnall, Maisa S. Ziadni, Anuradha Roy, Ming-Chih Kao, John A. Sturgeon, Karon F. Cook, Kate Lorig, John W. Burns, Sean C. Mackey
Restrictive Versus Massive Fluid Resuscitation Strategy (REFILL study), influence on blood loss and hemostatic parameters in obstetric hemorrhage: study protocol for a randomized controlled trial
Natascha de Lange, Pim Schol, Marcus Lancé, Mallory Woiski, Josje Langenveld, Robbert Rijnders, Luc Smits, Martine Wassen, Yvonne Henskens, Hubertina Scheepers
Effect of physical exercise on spontaneous physical activity energy expenditure and energy intake in overweight adults (the EFECT study): a study protocol for a randomized controlled trial
Vitor Barreto Paravidino, Mauro Felippe Felix Mediano, Inácio Crochemore M Silva, Andrea Wendt, Fabrício Boscolo Del Vecchio, Fabiana Alves Neves, Bruno de Souza Terra, Erika Alvarenga Corrêa Gomes, Anibal Sanchez Moura, Rosely Sichieri
Effectiveness of a combination of cognitive behavioral therapy and task-oriented balance training in reducing the fear of falling in patients with chronic stroke: study protocol for a randomized controlled trial
Tai-Wa Liu, Gabriel Y. F. Ng, Shamay S. M. Ng
The role of ixazomib as an augmented conditioning therapy in salvage autologous stem cell transplant (ASCT) and as a post-ASCT consolidation and maintenance strategy in patients with relapsed multiple myeloma (ACCoRd [UK-MRA Myeloma XII] trial): study protocol for a Phase III randomised controlled trial
Alina Striha, A. John Ashcroft, Anna Hockaday, David A. Cairns, Karen Boardman, Gwen Jacques, Cathy Williams, John A. Snowden, Mamta Garg, Jamie Cavenagh, Kwee Yong, Mark T. Drayson, Roger Owen, Mark Cook, Gordon Cook
Cardiac output Optimisation following Liver Transplant (COLT) trial: study protocol for a feasibility randomised controlled trial
Farid Froghi, Rahul Koti, Kurinchi Gurusamy, Susan Mallett, Douglas Thorburn, Linda Selves, Sarah James, Jeshika Singh, Manuel Pinto, Christine Eastgate, Margaret McNeil, Helder Filipe, Fatima Jichi, Nick Schofield, Daniel Martin, Brian Davidson
Auricular acupressure for insomnia in hemodialysis patients: study protocol for a randomized controlled trial
Yuchi Wu, Lihong Yang, Lingli Li, Xiuqing Wu, Zhicong Zhong, Zhiren He, Hongyan Ma, Lixin Wang, Zhaoyu Lu, Cun Cai, Daixin Zhao, Xiangxin Meng, Airong Qi, Aicheng Yang, Guobin Su, Xinfeng Guo, Xusheng Liu, Chuan Zou, Qizhan Lin
A feasibility study for NOn-Traditional providers to support the management of Elderly People with Anxiety and Depression: The NOTEPAD study Protocol
Heather Burroughs, Bernadette Bartlam, Mo Ray, Tom Kingstone, Tom Shepherd, Reuben Ogollah, Janine Proctor, Waquas Waheed, Peter Bower, Peter Bullock, Karina Lovell, Simon Gilbody, Della Bailey, Stephanie Butler-Whalley, Carolyn Chew-Graham
Go Play Outside! Effects of a risk-reframing tool on mothers’ tolerance for, and parenting practices associated with, children’s risky play: study protocol for a randomized controlled trial
Mariana Brussoni, Takuro Ishikawa, Christina Han, Ian Pike, Anita Bundy, Guy Faulkner, Louise C. Mâsse
Dedicated mobile application for drug adverse reaction reporting by patients with relapsing remitting multiple sclerosis (Vigip-SEP study): study protocol for a randomized controlled trial
Gilles Defer, Florian Le Caignec, Sophie Fedrizzi, François Montastruc, Damien Chevanne, Jean-Jacques Parienti, Laure Peyro-Saint-Paul
Effectiveness and cost-effectiveness of humanistic counselling in schools for young people with emotional distress (ETHOS): study protocol for a randomised controlled trial
Megan Rose Stafford, Mick Cooper, Michael Barkham, Jeni Beecham, Peter Bower, Karen Cromarty, Andrew J. B. Fugard, Charlie Jackson, Peter Pearce, Rebekah Ryder, Cathy Street
Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child nutritional outcomes in rural Odisha, India: study protocol for a cluster randomised controlled trial
Suneetha Kadiyala, Audrey Prost, Helen Harris-Fry, Meghan O’Hearn, Ronali Pradhan, Shibananth Pradhan, Naba Kishore Mishra, Suchitra Rath, Nirmala Nair, Shibanand Rath, Prasantha Tripathy, Sneha Krishnan, Peggy Koniz-Booher, Heather Danton, Diana Elbourne, Joanna Sturgess, Emma Beaumont, Hassan Haghparast-Bidgoli, Jolene Skordis-Worrall, Satyanarayan Mohanty, Avinash Upadhay, Elizabeth Allen
Does feedback on daily activity level from a Smart watch during inpatient stroke rehabilitation increase physical activity levels? Study protocol for a randomized controlled trial
Yun Dong, Dax Steins, Shanbin Sun, Fei Li, James D. Amor, Christopher J. James, Zhidao Xia, Helen Dawes, Hooshang Izadi, Yi Cao, Derick T. Wade, Yuanfeng Peng, Jingjing Xue, Xiaoli Guo, Xuesong Xie, Na Zuo, Xinkui Gao, Lingzhi Wu, Peifang Li, Ying Wang, Chong Chen, Peiyang Sun, Jinji Wang, Feifei Wang, Panfu Hao, Weiwei Wu, Yubao Gao, Xiaoli Sun, Haiyang Wu, Yujie Yang
Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan
Wes Onland, Maruschka P. Merkus, Debbie H. Nuytemans, Marijke C. Jansen-van der Weide, Rebecca Holman, Anton H. van Kaam
Circulating stem cells, HIF-1, and SDF-1 in septic abdominal surgical patients: randomized controlled study protocol
Antonella Cotoia, Lucia Mirabella, Sabrina Altamura, Rachele Villani, Flavia Marchese, Giuseppe Ferrara, Karim Mariano, Tullo Livio, Gilda Cinnella
Management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: The SingHypertension cluster randomized trial
Tazeen H. Jafar, Ngiap Chuan Tan, John C. Allen, Eric A. Finkelstein, Paul Goh, Peter Moey, Joanne Hui Min Quah, Siew Wai Hwang, Juliana Bahadin, Anandan Gerard Thiagarajah, Jason Chan, Gary Kang, Agnes Koong
Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial
Fred Stephen Sarfo, Osei Sarfo-Kantanka, Sheila Adamu, Vida Obese, Jennifer Voeks, Raelle Tagge, Vipin Sethi, Bruce Ovbiagele
Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial
Yaseen Arabi, Fahad Al-Hameed, Karen E. A. Burns, Sangeeta Mehta, Sami Alsolamy, Mohammed Almaani, Yasser Mandourah, Ghaleb A. Almekhlafi, Ali Al Bshabshe, Simon Finfer, Mohammed Alshahrani, Imran Khalid, Yatin Mehta, Atul Gaur, Hassan Hawa, Hergen Buscher, Zia Arshad, Hani Lababidi, Abdulsalam Al Aithan, Jesna Jose, Sheryl Ann I. Abdukahil, Lara Y. Afesh, Maamoun Dbsawy, Abdulaziz Al-Dawood, Yaseen Arabi, Abdulaziz Al-Dawood, Sami Alsolamy, Mohamed Hegazy, Maamoun Dbsawy, Sheryl Ann I. Abdukahil, Lara Afesh, Fahad Al-Hameed, Gulam Rasool, Jalal Rifai, Ali S. Mohamed, Ohoud Al Orabi, Yasser Mandourah, Ghaleb Almekhlafi, Dina Al Sufiani, Emad Al Amodi, Mohamed Alkhader, Shatha Awad, Ma. Raylin Cubio Cabal, Jean S. Valerio, Sahar Hassan, Bander Alanazi, Kholoud Alharbi, Ahmad Alenazy, Mohammed Alshahrani, Laila Perlas Asonto, Kathrina Libunao-de Loyola, Ali Al Bshabshe, Abdulmoniem Albahar, Ali Alamri, Abdulsalam Al Aithan, Shahinaz Bashir, Mohammed Almaani, Hani Lababidi, Husain Abdulmuthalib, Pendo Ntinika, Rachelle Pangilinan, Imran Khalid, Abdulaziz Jadkareem, Eman Bawazeer, Sawsan Bassi, Hassan Hawa, Khalid Maghrabi, Mohammad Hijazi, Musaab Abdelhai, Ellen Joy Pagunsan, Marketa Vinklerova, Sangeeta Mehta, Sumesh Shah, Erik Tamberg, Karen Burns, Orla Smith, Marlene Santos, Gyan Sandhu, Jennifer Hodder, Kurtis Salway, Michael Jacka, Lorena McCoshen, Nadia Baig, Atul Gaur, Katrina Ellis, Mary White, Rebecca Gregory, Rob Cameron, Simon Finfer, Anne O’Connor, Elizabeth Yarad, Frances Bass, Naomi Hammond, Hergen Buscher, Claire Reynolds, Karlee McCann, Zia Arshad, Sachin Kumar Srivastava, Avinash Singh, Yatin Mehta, Joby George, Chitra Mehta, Ashish Kumar
The CIRCuiTS study (Implementation of cognitive remediation in early intervention services): protocol for a randomised controlled trial
Til Wykes, Eileen Joyce, Tjasa Velikonja, Andrew Watson, Gregory Aarons, Max Birchwood, Matteo Cella, Sue Dopson, David Fowler, Kathy Greenwood, Sonia Johnson, Paul McCrone, Jesus Perez, Andrew Pickles, Clare Reeder, Diana Rose, Swaran Singh, Dominic Stringer, Matthew Taylor, Rumina Taylor, Rachel Upthegrove
Effects of heart rate variability biofeedback during exposure to fear-provoking stimuli within spider-fearful individuals: study protocol for a randomized controlled trial
Sarah K. Schäfer, Frank R. Ihmig, Karen A. Lara H., Frank Neurohr, Stephan Kiefer, Marlene Staginnus, Johanna Lass-Hennemann, Tanja Michael
Comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial
Bronwyn Myers, Crick Lund, Carl Lombard, John Joska, Naomi Levitt, Christopher Butler, Susan Cleary, Tracey Naledi, Peter Milligan, Dan J. Stein, Katherine Sorsdahl
The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial
Ditte Beck Jepsen, Jesper Ryg, Niklas Rye Jørgensen, Stinus Hansen, Tahir Masud
Microfinance for women at high risk for HIV in Kazakhstan: study protocol for a cluster-randomized controlled trial
Tara McCrimmon, Susan Witte, Gaukhar Mergenova, Assel Terlikbayeva, Sholpan Primbetova, Azamat Kuskulov, Scarlett L. Bellamy, Nabila El-Bassel
The efficacy of the traditional Chinese medicine Juanbi pill combined with methotrexate in active rheumatoid arthritis: study protocol for a randomized controlled trial
Qiong Wang, Yi-Ru Wang, Qing-Yun Jia, Li Liu, Chong-Qing Xu, Xiao-Yun Wang, Min Yao, Xue-Jun Cui, Qi Shi, Yong-Jun Wang, Qian-Qian Liang
Cerebral microembolism in the critically ill with acute kidney injury (COMET-AKI trial): study protocol for a randomized controlled clinical trial
Gabor Erdoes, Dominik E. Uehlinger, Beatrice Kobel, Monika P. Stucki, Roland Wiest, Frank Stueber, Niklaus Fankhauser, Stephan M. Jakob, Joerg C. Schefold
Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings
George Mtove, Joshua Kimani, William Kisinza, Geofrey Makenga, Peter Mangesho, Stephan Duparc, Miriam Nakalembe, Kamija S. Phiri, Russell Orrico, Ricardo Rojo, Pol Vandenbroucke
A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial
Macarena Gil-Pagés, Javier Solana, Rocío Sánchez-Carrión, Jose M. Tormos, Antonia Enseñat-Cantallops, Alberto García-Molina
Collaborative care for the detection and management of depression among adults with hypertension in South Africa: study protocol for the PRIME-SA randomised controlled trial
Inge Petersen, Arvin Bhana, Naomi Folb, Graham Thornicroft, Babalwa Zani, One Selohilwe, Ruwayda Petrus, Ntokozo Mntambo, Daniella Georgeu-Pepper, Tasneem Kathree, Crick Lund, Carl Lombard, Max Bachmann, Thomas Gaziano, Naomi Levitt, Lara Fairall
Collaborative care for the detection and management of depression among adults receiving antiretroviral therapy in South Africa: study protocol for the CobALT randomised controlled trial
Lara Fairall, Inge Petersen, Babalwa Zani, Naomi Folb, Daniella Georgeu-Pepper, One Selohilwe, Ruwayda Petrus, Ntokozo Mntambo, Arvin Bhana, Carl Lombard, Max Bachmann, Crick Lund, Jill Hanass-Hancock, Daniel Chisholm, Paul McCrone, Sergio Carmona, Thomas Gaziano, Naomi Levitt, Tasneem Kathree, Graham Thornicroft
Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial
Máire-Bríd Casey, Keith Smart, Ricardo Segurado, Conor Hearty, Hari Gopal, Damien Lowry, Dearbhail Flanagan, Lance McCracken, Catherine Doody
Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)
Lauren M. Bullens, Alexandra D. J. Hulsenboom, Suzanne Moors, Rohan Joshi, Pieter J. van Runnard Heimel, M. Beatrijs van der Hout-van der Jagt, Edwin R. van den Heuvel, S. Guid Oei
Improving Recovery and Outcomes Every Day after the ICU (IMPROVE): study protocol for a randomized controlled trial
Sophia Wang, Jessica Hammes, Sikandar Khan, Sujuan Gao, Amanda Harrawood, Stephanie Martinez, Lyndsi Moser, Anthony Perkins, Frederick W. Unverzagt, Daniel O. Clark, Malaz Boustani, Babar Khan
Systematic Techniques to Enhance rEtention in Randomised controlled trials: the STEER study protocol
Katie Gillies, Peter Bower, Jim Elliott, Graeme MacLennan, Rumana S. N. Newlands, Margaret Ogden, Shaun P. Treweek, Mary Wells, Miles D. Witham, Bridget Young, Jill J. Francis
Sample size implications of mortality definitions in sepsis: a retrospective cohort study
Sushant Govindan, Hallie C. Prescott, Vineet Chopra, Theodore J. Iwashyna
The effects of different forms of daily exercise on metabolic function following short-term overfeeding and reduced physical activity in healthy young men: study protocol for a randomised controlled trial
Jean-Philippe Walhin, Yung-Chih Chen, Aaron Hengist, James Bilzon, James A. Betts, Dylan Thompson
Chinese herbal medicine Shenzhuo Formula treatment in patients with macroalbuminuria secondary to diabetic kidney disease: study protocol for a randomized controlled trial
Xue-min Zhao, Ying Zhang, Xin-hui He, Hong-dong Chen, Zhu-feng Wang, Jing Guo, Xin-miao Wang, Ze-zheng Gao, Ji-ping Wang, Wei Liu, Lin-hua Zhao, Xiao-lin Tong
The ideal time of systemic metronidazole and amoxicillin administration in the treatment of severe periodontitis: study protocol for a randomized controlled trial
Magda Feres, Belén Retamal-Valdes, Maria Josefa Mestnik, Luciene Cristina de Figueiredo, Marcelo Faveri, Poliana M. Duarte, Aretuza Fritoli, Elisangela Faustino, Maria Luisa Silveira Souto, Michelle de Franco Rodrigues, Marcela Giudicissi, Bárbara Campos Lara Nogueira, Luciana Saraiva, Giuseppe Alexandre Romito, Cláudio Mendes Pannuti
Effects of Dangguixu-san on acute lateral ankle sprain: study protocol for a randomized controlled trial
Jae-Hong Kim, Eun-Yong Lee, Myung-Rae Cho, Cham-Kyul Lee, Ji-Hyun Cho
Acceptance and Commitment Therapy preceded by an experimental Attention Bias Modification procedure in recurrent depression: study protocol for a randomized controlled trial
Tom Østergaard, Tobias Lundgren, Robert Zettle, Rune Jonassen, Catherine J. Harmer, Tore C. Stiles, Nils Inge Landrø, Vegard Øksendal Haaland
Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: 5 Phase Study Protocol
Ayano Kelly, Allison Tong, Kathleen Tymms, Lyn March, Jonathan C. Craig, Mary De Vera, Vicki Evans, Geraldine Hassett, Karine Toupin-April, Bart van den Bemt, Armando Teixeira-Pinto, Rieke Alten, Susan J. Bartlett, Willemina Campbell, Therese Dawson, Michael Gill, Renske Hebing, Alexa Meara, Robby Nieuwlaat, Yomei Shaw, Jasvinder A. Singh, Maria Suarez-Almazor, Daniel Sumpton, Peter Wong, Robin Christensen, Dorcas Beaton, Maarten de Wit, Peter Tugwell, Marieke Scholte-Voshaar, Khoula AlMaqbali, Annica Barcenilla-Wong, Peter Cheung, Luke Crimston-Smith, Marita Cross, Rebecca Davey, Paul Emery, Kieran Fallon, Sarah Flint, David Graham, Stephen Hall, Susan Hermann, Helen Keen, Katerina Koutsogianni, Irwin Lim, Francois Nantel, Sean O’Neill, Clare O’Sullivan, Premarani Sinnathurai, Biljana Zeljkovic, Ayano Kelly, Allison Tong, Kathleen Tymms, Lyn March, Mary De Vera, Vicki Evans, Geraldine Hassett, Karine Toupin-April, Bart van den Bemt, Marieke Scholte-Voshaar, Susan Bartlett, Peter Tugwell, Lyn March, Rieke Alten, Willemina Campbell, Therese Dawson, Michael Gill, Renske Hebing, Alexa Meara, Robby Nieuwlaat, Yomei Shaw, Jasvinder A. Singh, Maria Suarez-Almazor, Daniel Sumpton, Peter Wong, Robin Christensen, Dorcas Beaton, Maarten de Wit
Patient-centered recruitment and retention for a randomized controlled study
Sumedha Chhatre, Ashlie Jefferson, Ratna Cook, Caitlin R. Meeker, Ji Hyun Kim, Kayla Marie Hartz, Yu-Ning Wong, Adele Caruso, Diane K. Newman, Knashawn H. Morales, Ravishankar Jayadevappa
Evaluation of a novel device for the management of high blood pressure and shock in pregnancy in low-resource settings: study protocol for a stepped-wedge cluster-randomised controlled trial (CRADLE-3 trial)
Hannah L. Nathan, Kate Duhig, Nicola Vousden, Elodie Lawley, Paul T. Seed, Jane Sandall, Mrutyunjaya B. Bellad, Adrian C. Brown, Lucy C. Chappell, Shivaprasad S. Goudar, Muchabayiwa F. Gidiri, Andrew H. Shennan, Natasha L. Hezelgrave, Umesh Charantimath, Chandrappa C. Karadiguddi, Sphoorthi S. Mastiholi, Geetanjali M. Mungarwadi, Feiruz Surur, Lomi Yadeta, Yonas Guchale, Violet Mambo, Sebastian Chinkoyo, Thokozile Musonda, Christine Jere, Bellington Vwalika, Mercy Kopeka, Martina Chima, Josephine Miti, Rebecca Best, Matthew Clarke, Jesse Kamara, Jeneba Conteh, Patricia Sandi, Margaret Sesay, Fatmata Momodou, Julius Wandabwa, James Ditai, Nathan Mackayi Odeke, Annettee Nakimuli, Josaphat Byamugisha, Dorothy Namakula, Noela Kalyowa, Doreen Birungi, Emily Nakirijja, Carwyn Hill, Grace Greene, Adeline Vixama, Paul Toussaint, Grace Makonyola, Doreen Bukani, Monice Kachinjika, Jane Makwakwa
Fluid hydration to prevent post-ERCP pancreatitis in average- to high-risk patients receiving prophylactic rectal NSAIDs (FLUYT trial): study protocol for a randomized controlled trial
Xavier J. N. M. Smeets, David W. da Costa, Paul Fockens, Chris J. J. Mulder, Robin Timmer, Wietske Kievit, Marieke Zegers, Marco J. Bruno, Marc G. H. Besselink, Frank P. Vleggaar, Rene W. M. van der Hulst, Alexander C. Poen, Gerbrand D. N. Heine, Niels G. Venneman, Jeroen J. Kolkman, Lubbertus C. Baak, Tessa E. H. Römkens, Sven M. van Dijk, Nora D. L. Hallensleben, Wim van de Vrie, Tom C. J. Seerden, Adriaan C. I. T. L. Tan, Annet M. C. J. Voorburg, Jan-Werner Poley, Ben J. Witteman, Abha Bhalla, Muhammed Hadithi, Willem J. Thijs, Matthijs P. Schwartz, Jan Maarten Vrolijk, Robert C. Verdonk, Foke van Delft, Yolande Keulemans, Harry van Goor, Joost P. H. Drenth, Erwin J. M. van Geenen
Telerehabilitation for aphasia – protocol of a pragmatic, exploratory, pilot randomized controlled trial
Hege Prag Øra, Melanie Kirmess, Marian C. Brady, Ingvild Elisabeth Winsnes, Silje Merethe Hansen, Frank Becker
Evaluation of mindfulness-based cognitive therapy for life and a cognitive behavioural therapy stress-management workshop to improve healthcare staff stress: study protocol for two randomised controlled trials
Clara Strauss, Jenny Gu, Nikki Pitman, Cavita Chapman, Willem Kuyken, Adrian Whittington
Rationale and design for cognitive behavioral therapy for anxiety disorders in children with autism spectrum disorder: a study protocol of a randomized controlled trial
Tina R. Kilburn, Merete Juul Sørensen, Mikael Thastum, Ronald M. Rapee, Charlotte Ulrikka Rask, Kristian Bech Arendt, Per Hove Thomsen
Assessing the effectiveness of Enhanced Psychological Care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): a pilot cluster randomised controlled trial
Suzanne H. Richards, Chris Dickens, Rob Anderson, David A. Richards, Rod S. Taylor, Obioha C. Ukoumunne, Katrina M. Turner, Manish Gandhi, Willem Kuyken, Andrew Gibson, Antoinette Davey, Fiona Warren, Rachel Winder, John Campbell
Stereotactic body-radiotherapy boost dose of 18 Gy vs 21 Gy in combination with androgen-deprivation therapy and whole-pelvic radiotherapy for intermediate- or high-risk prostate cancer: a study protocol for a randomized controlled, pilot trial
Yeon Joo Kim, Hanjong Ahn, Choung-Soo Kim, Jae-Lyun Lee, Young Seok Kim
Improving outcomes after pediatric cardiac arrest – the ICU-Resuscitation Project: study protocol for a randomized controlled trial
Ron W. Reeder, Alan Girling, Heather Wolfe, Richard Holubkov, Robert A. Berg, Maryam Y. Naim, Kathleen L. Meert, Bradley Tilford, Joseph A. Carcillo, Melinda Hamilton, Matthew Bochkoris, Mark Hall, Tensing Maa, Andrew R. Yates, Anil Sapru, Robert Kelly, Myke Federman, J. Michael Dean, Patrick S. McQuillen, Deborah Franzon, Murray M. Pollack, Ashley Siems, John Diddle, David L. Wessel, Peter M. Mourani, Carleen Zebuhr, Robert Bishop, Stuart Friess, Candice Burns, Shirley Viteri, David A. Hehir, R. Whitney Coleman, Tammara L. Jenkins, Daniel A. Notterman, Robert F. Tamburro, Robert M. Sutton
A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial
Ryota Niikura, Naoyoshi Nagata, Atsuo Yamada, Hisashi Doyama, Yasutoshi Shiratori, Tsutomu Nishida, Shu Kiyotoki, Tomoyuki Yada, Tomoki Fujita, Tetsuya Sumiyoshi, Kenkei Hasatani, Tatsuya Mikami, Tetsuro Honda, Katsuhiro Mabe, Kazuo Hara, Katsumi Yamamoto, Mariko Takeda, Munenori Takata, Mototsugu Tanaka, Tomohiro Shinozaki, Mitsuhiro Fujishiro, Kazuhiko Koike
Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial
Adrian Wells, Kirsten McNicol, David Reeves, Peter Salmon, Linda Davies, Anthony Heagerty, Patrick Doherty, Rebecca McPhillips, Rebecca Anderson, Cintia Faija, Lora Capobianco, Helen Morley, Hannah Gaffney, Gemma Shields, Peter Fisher
SPIRE – combining SGI-110 with cisplatin and gemcitabine chemotherapy for solid malignancies including bladder cancer: study protocol for a phase Ib/randomised IIa open label clinical trial
Simon Crabb, Sarah J. Danson, James W. F. Catto, Cathy McDowell, James N. Lowder, Joshua Caddy, Denise Dunkley, Jessica Rajaram, Deborah Ellis, Stephanie Hill, David Hathorn, Amy Whitehead, Mihalis Kalevras, Robert Huddart, Gareth Griffiths
Continuous versus intermittent endotracheal cuff pressure control for the prevention of ventilator-associated respiratory infections in Vietnam: study protocol for a randomised controlled trial
Vu Quoc Dat, Ronald B. Geskus, Marcel Wolbers, Huynh Thi Loan, Lam Minh Yen, Nguyen Thien Binh, Le Thanh Chien, Nguyen Thi Hoang Mai, Nguyen Hoan Phu, Nguyen Phu Huong Lan, Nguyen Van Hao, Hoang Bao Long, Tran Phuong Thuy, Nguyen Van Kinh, Nguyen Vu Trung, Vu Dinh Phu, Nguyen Trung Cap, Dao Tuyet Trinh, James Campbell, Evelyne Kestelyn, Heiman F. L. Wertheim, Duncan Wyncoll, Guy Edward Thwaites, H. Rogier van Doorn, C. Louise Thwaites, Behzad Nadjm
A couple-based HIV prevention intervention for Latino men who have sex with men: study protocol for a randomized controlled trial
Omar Martinez, M. Isabel Fernandez, Elwin Wu, Alex Carballo-Diéguez, Guillermo Prado, Adam Davey, Ethan Levine, Brian Mattera, Nikki Lopez, Omar Valentin, Ashley Murray, Madeline Sutton
Is treatment outcome improved if patients match themselves to treatment options? Study protocol for a randomized controlled trial
Morten Ellegaard Hell, William R. Miller, Bent Nielsen, Anette Søgaard Nielsen
COMplex Fracture Orthopedic Rehabilitation (COMFORT) - Real-time visual biofeedback on weight bearing versus standard training methods in the treatment of proximal femur fractures in the elderly: study protocol for a multicenter randomized controlled trial
Marco Raaben, Syaiful Redzwan, Robin Augustine, Taco Johan Blokhuis
Open-label, randomized multicentre phase II study to assess the efficacy and tolerability of sunitinib by dose administration regimen (dose modification or dose interruptions) in patients with advanced or metastatic renal cell carcinoma: study protocol of the SURF trial
Guillaume Mouillet, Marie-Justine Paillard, Tristan Maurina, Dewi Vernerey, Thierry Nguyen Tan Hon, Hamadi Almotlak, Ulrich Stein, Fabien Calcagno, Diane Berthod, Elise Robert, Aurelia Meurisse, Antoine Thiery-Vuillemin
Pancreatoduodenectomy with or without prophylactic falciform ligament wrap around the gastroduodenal artery stump for prevention of pancreatectomy hemorrhage
Benjamin Müssle, Leonie Zühlke, Ann Wierick, Dorothée Sturm, Xina Grählert, Marius Distler, Nuh N. Rahbari, Jürgen Weitz, Thilo Welsch
Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial
Lahiru Russell, Anna Ugalde, Donna Milne, Meinir Krishnasamy, Eric O (Seung Chul), David W Austin, Richard Chambers, Liliana Orellana, Patricia M Livingston
Effectiveness of school dental screening on dental visits and untreated caries among primary schoolchildren: study protocol for a cluster randomised controlled trial
Haya Alayadi, Wael Sabbah, Eduardo Bernabé
Mecasin treatment in patients with amyotrophic lateral sclerosis: study protocol for a randomized controlled trial
Sungha Kim, Jae Kyoun Kim, Mi Ju Son, Dongwoung Kim, Bongkeun Song, Ilhong Son, Hyung Won Kang, Jongdeok Lee, Sungchul Kim
Can Arthroplasty Stem INfluence Outcome? (CASINO): a randomized controlled equivalence trial of 125 mm versus 150 mm Exeter V40 stems in total hip arthroplasty
David F. Hamilton, Nicholas E. Ohly, Paul Gaston
ENdometrial cancer SURvivors’ follow-up carE (ENSURE): Less is more? Evaluating patient satisfaction and cost-effectiveness of a reduced follow-up schedule: study protocol of a randomized controlled trial
Nicole P. M. Ezendam, Belle H. de Rooij, Roy F. P. M. Kruitwagen, Carien L. Creutzberg, Ingrid van Loon, Dorry Boll, M. Caroline Vos, Lonneke V. van de Poll-Franse
A community-based physical activity intervention to prevent mobility-related disability for retired older people (REtirement in ACTion (REACT)): study protocol for a randomised controlled trial
Afroditi Stathi, Janet Withall, Colin J. Greaves, Janice L. Thompson, Gordon Taylor, Antonieta Medina-Lara, Colin Green, James Bilzon, Selena Gray, Heidi Johansen-Berg, Claire E. Sexton, Max J. Western, Jolanthe L. de Koning, Jessica C. Bollen, Sarah J. Moorlock, Naiara Demnitz, Poppy Seager, Jack M. Guralnik, W. Jack Rejeski, Ken R. Fox
SENSory re-learning of the UPPer limb after stroke (SENSUPP): study protocol for a pilot randomized controlled trial
Håkan Carlsson, Birgitta Rosén, Hélène Pessah-Rasmussen, Anders Björkman, Christina Brogårdh
Intervention using vitamin D for elevated urinary albumin in type 2 diabetes mellitus (IDEAL-2 Study): study protocol for a randomised controlled trial
Shahrad Taheri, Muhammad Asim, Hassan al Malki, Omar Fituri, Manikkam Suthanthiran, Phyllis August, Muhammad Asim, Hassan Al-Malki, Omar Fituri, Awad Rachid, Abdelaziz Adel, Ahmed Hamdi, Awais Nauman, Gamal Farghaly, Mohamad Elkadi, Shahrad Taheri, Phyllis August, Manikkam Suthanthiran, Amin Jayyousi, Buthaina Ibrahim, Ibrahim Janahi, Robert Menzies, Seleena Farook, Salma Bashir, Odette Chagoury, Sopna Choudhury, Sherryl Payra, Omar Omar, Maria Pallayova, Sahar Agouba, Sally Elgazzar, Hadya Elshakh, Hoda Gad, Samah Chalil, Amany Dahir, Hiba Tohid, Subitha Chinnaiyan
Effects of cyclosporine A pretreatment of deceased organ donors on kidney graft function (Cis-A-rein): study protocol for a randomized controlled trial
Jean-Christophe Orban, Eric Fontaine, Elisabeth Cassuto, Karine Baumstarck, Marc Leone, Jean-Michel Constantin, Carole Ichai
Implementation of telemedicine for knee osteoarthritis: study protocol for a randomized controlled trial
Zhengping Huang, Xia Pan, Weiming Deng, Zhixiang Huang, Yukai Huang, Xuechan Huang, Zhaohua Zhu, Weiyu Han, Shaoling Zheng, Xin Guo, Changhai Ding, Tianwang Li
CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial
Dean A. Fennell, Emma Kirkpatrick, Kelly Cozens, Mavis Nye, Jason Lester, Gerard Hanna, Nicola Steele, Peter Szlosarek, Sarah Danson, Joanne Lord, Christian Ottensmeier, Daniel Barnes, Stephanie Hill, Mihalis Kalevras, Tom Maishman, Gareth Griffiths
Erythropoietin as an add-on treatment for cognitive side effects of electroconvulsive therapy: a study protocol for a randomized controlled trial
Lejla Sjanic Schmidt, Jeff Zarp Petersen, Maj Vinberg, Ida Hageman, Niels Vidiendal Olsen, Lars Vedel Kessing, Martin Balslev Jørgensen, Kamilla Woznica Miskowiak
Mobile Link – a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial
Carinne Brody, Sovannary Tuot, Pheak Chhoun, Dallas Swendenman, Kathryn C. Kaplan, Siyan Yi
Parenting Resilient Kids (PaRK), an online parenting program to prevent anxiety and depression problems in primary school-aged children: Study protocol for a randomised controlled trial
Luwishennadige Madhawee N. Fernando, Wan Hua Sim, Anthony F. Jorm, Ron Rapee, Katherine A. Lawrence, Marie B. H. Yap
Shorter treatment for minimal tuberculosis (TB) in children (SHINE): a study protocol for a randomised controlled trial
Chishala Chabala, Anna Turkova, Margaret J. Thomason, Eric Wobudeya, Syed Hissar, Vidya Mave, Marieke van der Zalm, Megan Palmer, Monica Kapasa, Perumal K. Bhavani, Sarath Balaji, Priyanka A. Raichur, Anne-Marie Demers, Graeme Hoddinott, Ellen Owen-Powell, Aarti Kinikar, Philippa Musoke, Veronica Mulenga, Rob Aarnoutse, Helen McIlleron, Anneke Hesseling, Angela M. Crook, Mark Cotton, Diana M. Gibb
Are randomised controlled trials positivist? Reviewing the social science and philosophy literature to assess positivist tendencies of trials of social interventions in public health and health services
Chris Bonell, Graham Moore, Emily Warren, Laurence Moore
Long-term scar quality after hydrosurgical versus conventional debridement of deep dermal burns (HyCon trial): study protocol for a randomized controlled trial
Catherine M. Legemate, Harold Goei, Esther Middelkoop, Irma M. M. H. Oen, Tim H. J. Nijhuis, Kelly A. A. Kwa, Paul P. M. van Zuijlen, Gerard I. J. M. Beerthuizen, Marianne K. Nieuwenhuis, Margriet E. van Baar, Cornelis H. van der Vlies
Stages of behavioural change after direct-to-consumer disease risk profiling: study protocol of two integrated controlled pragmatic trials
Kelly F. J. Stewart, Anke Wesselius, Annemie M. W. J. Schols, Maurice P. Zeegers
Treating prolonged grief disorder with prolonged grief-specific cognitive behavioral therapy: study protocol for a randomized controlled trial
Rita Rosner, Eline Rimane, Anna Vogel, Jörn Rau, Maria Hagl
Does sensorimotor upper limb therapy post stroke alter behavior and brain connectivity differently compared to motor therapy? Protocol of a phase II randomized controlled trial
Nele De Bruyn, Bea Essers, Liselot Thijs, Annick Van Gils, Lisa Tedesco Triccas, Sarah Meyer, Kaat Alaerts, Geert Verheyden
Single-implant overdentures retained by the Novaloc attachment system: study protocol for a mixed-methods randomized cross-over trial
Raphael F. de Souza, Christophe Bedos, Shahrokh Esfandiari, Nicholas M. Makhoul, Didem Dagdeviren, Samer Abi Nader, Areej A. Jabbar, Jocelyne S. Feine
Chemoprophylaxis of leprosy with rifampicin in contacts of multibacillary patients: study protocol for a randomized controlled trial
Daiane Santos dos Santos, Nádia Cristina Duppre, Euzenir Nunes Sarno, Roberta Olmo Pinheiro, Anna Maria Sales, José Augusto Da Costa Nery, Milton Ozório Moraes, Luiz Antônio Bastos Camacho
Prophylactic antibiotics to reduce pelvic infection in women having miscarriage surgery – The AIMS (Antibiotics in Miscarriage Surgery) trial: study protocol for a randomized controlled trial
David Lissauer, Amie Wilson, Jane Daniels, Lee Middleton, Jon Bishop, Catherine Hewitt, Abi Merriel, Andrew Weeks, Chisale Mhango, Ronald Mataya, Frank Taulo, Theresa Ngalawesa, Agatha Chirwa, Colleta Mphasa, Tayamika Tambala, Grace Chiudzu, Caroline Mwalwanda, Agnes Mboma, Rahat Qureshi, Iffat Ahmed, Humera Ismail, Metin Gulmezoglu, Olufemi T. Oladapo, Godfrey Mbaruku, Jerome Chibwana, Grace Watts, Beatus Simon, James Ditai, Charles Otim Tom, Jane-Frances Acam, John Ekunait, Helen Uniza, Margaret Iyaku, Margaret Anyango, Javier Zamora, Tracy Roberts, Ilias Goranitis, Nicola Desmond, Arri Coomarasamy
N-of-1 trials in the clinical care of patients in developing countries: a systematic review
Chalachew Alemayehu, Jane Nikles, Geoffrey Mitchell
Developing a core outcome set for people living with dementia at home in their neighbourhoods and communities: study protocol for use in the evaluation of non-pharmacological community-based health and social care interventions
Andrew J. E. Harding, Hazel Morbey, Faraz Ahmed, Carol Opdebeeck, Ying-Ying Wang, Paula Williamson, Caroline Swarbrick, Iracema Leroi, David Challis, Linda Davies, David Reeves, Fiona Holland, Mark Hann, Ingrid Hellström, Lars-Christer Hydén, Alistair Burns, John Keady, Siobhan Reilly
Health consequences for mother and baby of substantial pre-conception weight loss in obese women: study protocol for a randomized controlled trial
Sarah Price, Alison Nankervis, Michael Permezel, Luke Prendergast, Priya Sumithran, Joseph Proietto
Effects of transcranial LED therapy on the cognitive rehabilitation for diffuse axonal injury due to severe acute traumatic brain injury: study protocol for a randomized controlled trial
João Gustavo Rocha Peixoto dos Santos, Ana Luiza Costa Zaninotto, Renato Amaro Zângaro, Ana Maria Costa Carneiro, Iuri Santana Neville, Almir Ferreira de Andrade, Manoel Jacobsen Teixeira, Wellingson Silva Paiva
The effect of regularly dosed paracetamol versus no paracetamol on renal function in Plasmodium knowlesi malaria (PACKNOW): study protocol for a randomised controlled trial
Daniel J. Cooper, Katherine Plewes, Matthew J. Grigg, Giri S. Rajahram, Kim A. Piera, Timothy William, Mark D. Chatfield, Tsin Wen Yeo, Arjen M. Dondorp, Nicholas M. Anstey, Bridget E. Barber
Combined Protocol for Acute Malnutrition Study (ComPAS) in rural South Sudan and urban Kenya: study protocol for a randomized controlled trial
Jeanette Bailey, Natasha Lelijveld, Bethany Marron, Pamela Onyoo, Lara S. Ho, Mark Manary, André Briend, Charles Opondo, Marko Kerac
The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation
Natasha Lelijveld, Jeanette Bailey, Amy Mayberry, Lani Trenouth, Dieynaba S. N’Diaye, Hassan Haghparast-Bidgoli, Chloe Puett
Hypericum perforatum to improve post-operative Pain Outcome after monosegmental Spinal microdiscectomy (HYPOS): a study protocol for a randomised, double-blind, placebo-controlled trial
Christa Raak, Wolfram Scharbrodt, Bettina Berger, Arndt Büssing, René Geißen, Thomas Ostermann
Individualised short-term therapy for adolescents impaired by attention-deficit/hyperactivity disorder despite previous routine care treatment (ESCAadol)—Study protocol of a randomised controlled trial within the consortium ESCAlife
Julia Geissler, Thomas Jans, Tobias Banaschewski, Katja Becker, Tobias Renner, Daniel Brandeis, Manfred Döpfner, Christina Dose, Christopher Hautmann, Martin Holtmann, Carolin Jenkner, Sabina Millenet, Marcel Romanos
Optimizing a community-engaged multi-level group intervention to reduce substance use: an application of the multiphase optimization strategy
Liliane Cambraia Windsor, Ellen Benoit, Douglas Smith, Rogério M. Pinto, Kari C. Kugler
The effects of Bifidobacterium animalis ssp. lactis B94 on gastrointestinal wellness in adults with Prader–Willi syndrome: study protocol for a randomized controlled trial
Zainab Alyousif, Jennifer L. Miller, Mariana Y. Sandoval, Chad W. MacPherson, Varuni Nagulesapillai, Wendy J. Dahl
Physical activity and nutrition intervention for Singaporean women aged 50 years and above: study protocol for a randomised controlled trial
Elaine Yee-Sing Wong, Andy H. Lee, Anthony P. James, Jonine Jancey
An eHealth program versus a standard care supervised health program and associated health outcomes in individuals with mobility disability: study protocol for a randomized controlled trial
Daniel Berglind, Gisela Nyberg, Mikaela Willmer, Margareta Persson, Michael Wells, Yvonne Forsell
Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial
Jeffrey Presneill, Dashiell Gantner, Alistair Nichol, Colin McArthur, Andrew Forbes, Jessica Kasza, Tony Trapani, Lynnette Murray, Stephen Bernard, Peter Cameron, Gilles Capellier, Olivier Huet, Lynette Newby, Stephen Rashford, Jeffrey V. Rosenfeld, Tony Smith, Michael Stephenson, Dinesh Varma, Shirley Vallance, Tony Walker, Steve Webb, D. James Cooper
Is intravenously administered, subdissociative-dose KETAmine non-inferior to MORPHine for prehospital analgesia (the KETAMORPH study): study protocol for a randomized controlled trial
Clément Le Cornec, Said Lariby, Vivien Brenckmann, Jean Benoit Hardouin, Claude Ecoffey, Marion Le Pottier, Philippe Fradin, Hélène Broch, Amine Kabbaj, Yannick Auffret, Florence Deciron, Céline Longo, François Javaudin, Quentin Le Bastard, Joël Jenvrin, Emmanuel Montassier
Tranexamic Acid versus Placebo to Prevent Blood Transfusion during Radical Cystectomy for Bladder Cancer (TACT): Study Protocol for a Randomized Controlled Trial
Rodney H. Breau, Luke T. Lavallée, Sonya Cnossen, Kelsey Witiuk, Ilias Cagiannos, Franco Momoli, Gregory Bryson, Salmaan Kanji, Christopher Morash, Alexis Turgeon, Ryan Zarychanski, Ranjeeta Mallick, Greg Knoll, Dean A. Fergusson
Smartphone-based ecological momentary assessment and intervention in a coping-focused intervention for hearing voices (SAVVy): study protocol for a pilot randomised controlled trial
Imogen H. Bell, Sarah F. Fielding-Smith, Mark Hayward, Susan L. Rossell, Michelle H. Lim, John Farhall, Neil Thomas
Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial
Anne Loes van den Boom, Elisabeth M. L. de Wijkerslooth, Joost van Rosmalen, Frédérique H. Beverdam, Evert-Jan G. Boerma, Marja A. Boermeester, Joanna W. A. M. Bosmans, Thijs A. Burghgraef, Esther C. J. Consten, Imro Dawson, Jan Willem T. Dekker, Marloes Emous, Anna A. W. van Geloven, Peter M. N. Y. H. Go, Luc A. Heijnen, Sander A. Huisman, Dayanara Jean Pierre, Joske de Jonge, Jurian H. Kloeze, Marc A. Koopmanschap, Hester R. Langeveld, Misha D. P. Luyer, Damian C. Melles, Johan W. Mouton, Augustinus P. T. van der Ploeg, Floris B. Poelmann, Jeroen E. H. Ponten, Charles C. van Rossem, Wilhelmina H. Schreurs, Joël Shapiro, Pascal Steenvoorde, Boudewijn R. Toorenvliet, Joost Verhelst, Hendt P. Versteegh, Rene M. H. Wijnen, Bas P. L. Wijnhoven
Administration of taurolidine-citrate lock solution for prevention of central venous catheter infection in adult neutropenic haematological patients: a randomised, double-blinded, placebo-controlled trial (TAURCAT)
C. Gudiol, S. Nicolae, C. Royo-Cebrecos, M. Aguilar-Guisado, I. Montero, C. Martín-Gandul, M. Perayre, D. Berbel, M. Encuentra, M. Arnan, J. M. Cisneros-Herreros, J. Carratalà
Outcome pre-specification requires sufficient detail to guard against outcome switching in clinical trials: a case study
Brennan C. Kahan, Vipul Jairath
The role of exercise combined with tocilizumab in visceral and epicardial adipose tissue and gastric emptying rate in abdominally obese participants: protocol for a randomised controlled trial
Regitse Højgaard Christensen, Anne-Sophie Wedell-Neergaard, Louise Lang Lehrskov, Grit Elster Legård, Emma Berndt Dorph, Stine Nymand, Maria Korf Ball, Morten Zacho, Robin Christensen, Helga Ellingsgaard, Jaya Birgitte Rosenmeier, Rikke Krogh-Madsen, Bente Klarlund Pedersen, Kristian Karstoft
Financial management of large, multi-center trials in a challenging funding milieu
Olivia Lovegreen, Danielle Riggs, Myrlene A. Staten, Patricia Sheehan, Anastassios G. Pittas
Synthetic versus autologous reconstruction (Syn-VAR) of the medial patellofemoral ligament: a study protocol for a randomised controlled trial
Adam Tucker, Sam McMahon, Bronwyn McArdle, Bridgeen Rutherford, Danny Acton
Patient consent to publication and data sharing in industry and NIH-funded clinical trials
O’Mareen Spence, Richie Onwuchekwa Uba, Seongbin Shin, Peter Doshi
A cluster randomised controlled trial of the Wellbeing in Secondary Education (WISE) Project – an intervention to improve the mental health support and training available to secondary school teachers: protocol for an integrated process evaluation
Rhiannon Evans, Rowan Brockman, Jillian Grey, Sarah Bell, Sarah Harding, David Gunnell, Rona Campbell, Simon Murphy, Tamsin Ford, William Hollingworth, Kate Tilling, Richard Morris, Bryar Kadir, Ricardo Araya, Judi Kidger
iSupport, an online training and support program for caregivers of people with dementia: study protocol for a randomized controlled trial in India
Kala M. Mehta, Dolores Gallagher-Thompson, Mathew Varghese, Santosh Loganathan, Upasana Baruah, Katrin Seeher, Diana Zandi, Tarun Dua, Anne Margriet Pot
RELAx – REstricted versus Liberal positive end-expiratory pressure in patients without ARDS: protocol for a randomized controlled trial
Anna Geke Algera, Luigi Pisani, Dennis C. J. Bergmans, Sylvia den Boer, Corianne A. J. de Borgie, Frank H. Bosch, Karina Bruin, Thomas G. Cherpanath, Rogier M. Determann, Arjen M. Dondorp, Dave A. Dongelmans, Henrik Endeman, Jasper J. Haringman, Janneke Horn, Nicole P. Juffermans, David M. van Meenen, Nardo J. van der Meer, Maruschka P. Merkus, Hazra S. Moeniralam, Ilse Purmer, Pieter Roel Tuinman, Mathilde Slabbekoorn, Peter E. Spronk, Alexander P. J. Vlaar, Marcelo Gama de Abreu, Paolo Pelosi, Ary Serpa Neto, Marcus J. Schultz, Frederique Paulus
Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial
Sandra Funcke, Bernd Saugel, Christian Koch, Dagmar Schulte, Thomas Zajonz, Michael Sander, Angelo Gratarola, Lorenzo Ball, Paolo Pelosi, Savino Spadaro, Riccardo Ragazzi, Carlo Alberto Volta, Thomas Mencke, Amelie Zitzmann, Benedikt Neukirch, Gonzalo Azparren, Marta Giné, Vicky Moral, Hans Otto Pinnschmidt, Oscar Díaz-Cambronero, Maria Jose Alberola Estelles, Marisol Echeverri Velez, Maria Vila Montañes, Javier Belda, Marina Soro, Jaume Puig, Daniel Arnulf Reuter, Sebastian Alois Haas
Progressive mobility program and technology to increase the level of physical activity and its benefits in respiratory, muscular system, and functionality of ICU patients: study protocol for a randomized controlled trial
Debora Stripari Schujmann, Adriana Claudia Lunardi, Carolina Fu
The efficacy and safety of Jiedu Tongluo granules for treating post-stroke depression with qi deficiency and blood stasis syndrome: study protocol for a randomized controlled trial
Ai-mei Zhao, Wen-ran Qiu, Li-jun Mao, Jun-guo Ren, Li Xu, Ming-jiang Yao, Kellie Bilinksi, Dennis Chang, Jian-xun Liu
Effectiveness of the KENKOJISEICHI local revitalization system on cognitive function change in older adults with mild cognitive impairment: study protocol for a randomized controlled trial
Songee Jung, Sungchul Lee, Seongryu Bae, Sangyoon Lee, Keitaro Makino, Yohei Shinkai, Hiroyuki Shimada
Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial
Vera Salvo, Jean Kristeller, Jesus Montero Marin, Adriana Sanudo, Bárbara Hatzlhoffer Lourenço, Mariana Cabral Schveitzer, Vania D’Almeida, Héctor Morillo, Suely Godoy Agostinho Gimeno, Javier Garcia-Campayo, Marcelo Demarzo
Pragmatic randomised clinical trials using electronic health records: general practitioner views on a model of a priori consent
Thomas Hills, Alex Semprini, Richard Beasley
Electroacupuncture for abdominal pain relief in patients with acute pancreatitis: study protocol for a randomized controlled trial
Dong Kee Jang, Chan Yung Jung, Kyung Ho Kim, Jun Kyu Lee
ESCAlate – Adaptive treatment approach for adolescents and adults with ADHD: study protocol for a randomized controlled trial
Toivo Zinnow, Tobias Banaschewski, Andreas J. Fallgatter, Carolin Jenkner, Florence Philipp-Wiegmann, Alexandra Philipsen, Wolfgang Retz, Esther Sobanski, Johannes Thome, Michael Rösler
Survey of professional views on sharing interim results by the Data Safety Monitoring Board (DSMB): what to share, with whom and why
Victoria Borg Debono, Lawrence Mbuagbaw, James Paul, Norman Buckley, Lehana Thabane
GoActive: a protocol for the mixed methods process evaluation of a school-based physical activity promotion programme for 13–14year old adolescents
Stephanie T. Jong, Helen Elizabeth Brown, Caroline H. D. Croxson, Paul Wilkinson, Kirsten L. Corder, Esther M. F. van Sluijs
Contributions of a survey and retrospective cohort study to the planning of a randomised controlled trial of corticosteroids in the treatment of paediatric septic shock
Anna Liu, Kusum Menon
Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial
Shahrad Taheri, Odette Chagoury, Hadeel Zaghloul, Sara Elhadad, Salma Hayder Ahmed, Omar Omar, Sherryl Payra, Salma Ahmed, Neda El Khatib, Rasha Abou Amona, Katie El Nahas, Matthew Bolton, Henem Chaar, Noor Suleiman, Amin Jayyousi, Mahmoud Zirie, Ibrahim Janahi, Wahiba Elhag, Abdulla Alnaama, Abduljaleel Zainel, Dahlia Hassan, Tim Cable, Mary Charlson, Martin Wells, Abdulla Al-Hamaq, Samya Al-Abdulla, Abdul Badi Abou-Samra
Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial
Sasha-Denise Grünzig, Harald Baumeister, Jürgen Bengel, David Ebert, Lena Krämer
TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial
Samuel McClinton, Sarah Cameron, Kathryn Starr, Ruth Thomas, Graeme MacLennan, Alison McDonald, Thomas Lam, James N’Dow, Mary Kilonzo, Robert Pickard, Ken Anson, Frank Keeley, Neil Burgess, Charles Terry Clark, Sara MacLennan, John Norrie
Exposure to a multi-level multi-component childhood obesity prevention community-randomized controlled trial: patterns, determinants, and implications
Angela Cristina Bizzotto Trude, Anna Yevgenyevna Kharmats, Jessica C. Jones-Smith, Joel Gittelsohn
Impact of preoperative patient education on the prevention of postoperative complications after major visceral surgery: the cluster randomized controlled PEDUCAT trial
Ulla Klaiber, Lisa M. Stephan-Paulsen, Thomas Bruckner, Gisela Müller, Silke Auer, Ingrid Farrenkopf, Christine Fink, Colette Dörr-Harim, Markus K. Diener, Markus W. Büchler, Phillip Knebel
A dose-response study of aerobic training for oxygen uptake, oxidative stress and cardiac autonomic function in type 2 diabetes mellitus: study protocol for a randomized controlled trial
Shalini Verma, Jamal Ali Moiz, Shahnawaz Anwer, Ahmad H. Alghadir, Mohammed Ejaz Hussain
World Health Organization “School Mental Health Manual”-based training for school teachers in Urban Lahore, Pakistan: study protocol for a randomized controlled trial
Nazish Imran, Atif Rahman, Nakhshab Chaudhry, Aftab Asif
A checklist for clinical trials in rare disease: obstacles and anticipatory actions—lessons learned from the FOR-DMD trial
Rebecca A. Crow, Kimberly A. Hart, Michael P. McDermott, Rabi Tawil, William B. Martens, Barbara E. Herr, Elaine McColl, Jennifer Wilkinson, Janbernd Kirschner, Wendy M. King, Michele Eagle, Mary W. Brown, Deborah Hirtz, Hanns Lochmuller, Volker Straub, Emma Ciafaloni, Perry B. Shieh, Stefan Spinty, Anne-Marie Childs, Adnan Y. Manzur, Lucia Morandi, Russell J. Butterfield, Iain Horrocks, Helen Roper, Kevin M. Flanigan, Nancy L. Kuntz, Jean K. Mah, Leslie Morrison, Basil T. Darras, Maja von der Hagen, Ulrike Schara, Ekkehard Wilichowski, Tiziana Mongini, Craig M. McDonald, Giuseppe Vita, Richard J. Barohn, Richard S. Finkel, Matthew Wicklund, Hugh J. McMillan Jr, Imelda Hughes, Elena Pegoraro, W. Bryan Burnette, James F. Howard, Mathula Thangarajh, Craig Campbell, Robert C. Griggs, Kate Bushby, Michela Guglieri
The effects of ipsilateral tilt position on right subclavian venous catheterization: study protocol for a prospective randomized trial
Dhong Eun Jung, Hyung-Chul Lee, Hyun-Kyu Yoon, Hee-Pyoung Park
A randomized controlled phase II trial of vaccination with lysate-loaded, mature dendritic cells integrated into standard radiochemotherapy of newly diagnosed glioblastoma (GlioVax): study protocol for a randomized controlled trial
Marion Rapp, Oliver M. Grauer, Marcel Kamp, Natalie Sevens, Nikola Zotz, Michael Sabel, Rüdiger V. Sorg
Physical Rehabilitation Core Outcomes In Critical illness (PRACTICE): protocol for development of a core outcome set
Bronwen Connolly, Linda Denehy, Nicholas Hart, Natalie Pattison, Paula Williamson, Bronagh Blackwood
Online interventions for problem gamblers with and without co-occurring problem drinking: study protocol of a randomized controlled trial
John A. Cunningham, David C. Hodgins, Matthew Keough, Christian S. Hendershot, Kylie Bennett, Anthony Bennett, Alexandra Godinho
Efficacy and safety of electro-acupuncture treatment in improving the consciousness of patients with traumatic brain injury: study protocol for a randomized controlled trial
Jie Liu, Xinsheng Xue, Ying Wu, Chaohua Yang, Ning Li, Huiping Li
Daptomycin versus placebo as an adjunct to beta-lactam therapy in the treatment of Staphylococcus aureus bacteremia: study protocol for a randomized controlled trial
Matthew P. Cheng, Alexander Lawandi, Guillaume Butler-Laporte, Katryn Paquette, Todd C. Lee
Post-trial follow-up methodology in large randomised controlled trials: a systematic review
Rebecca Llewellyn-Bennett, Danielle Edwards, Nia Roberts, Atticus H. Hainsworth, Richard Bulbulia, Louise Bowman
Evaluation of the clinical effectiveness of bioactive glass (S53P4) in the treatment of non-unions of the tibia and femur: study protocol of a randomized controlled non-inferiority trial
Michael C. Tanner, Raban Heller, Fabian Westhauser, Matthias Miska, Thomas Ferbert, Christian Fischer, Simone Gantz, Gerhard Schmidmaier, Patrick Haubruck
Sex and cardiovascular disease status differences in attitudes and willingness to participate in clinical research studies/clinical trials
Thomas S. Gruca, Wesley J. Hottel, Janine Comstock, Anna Olson, Gary E. Rosenthal
Music therapy versus treatment as usual for refugees diagnosed with posttraumatic stress disorder (PTSD): study protocol for a randomized controlled trial
Bolette Daniels Beck, Steen Teis Lund, Ulf Søgaard, Erik Simonsen, Thomas Christian Tellier, Torben Oluf Cordtz, Gunnar Hellmund Laier, Torben Moe
The AWED trial (Applying Wolbachia to Eliminate Dengue) to assess the efficacy of Wolbachia-infected mosquito deployments to reduce dengue incidence in Yogyakarta, Indonesia: study protocol for a cluster randomised controlled trial
Katherine L. Anders, Citra Indriani, Riris Andono Ahmad, Warsito Tantowijoyo, Eggi Arguni, Bekti Andari, Nicholas P. Jewell, Edwige Rances, Scott L. O’Neill, Cameron P. Simmons, Adi Utarini
Synergistic effect of acupuncture and mirror therapy on post-stroke upper limb dysfunction: a study protocol for a randomized controlled trial
Ying Xu, Shufang Lin, Cai Jiang, Xiaoqian Ye, Jing Tao, Schupp Wilfried, Alex W. K. Wong, Lidian Chen, Shanli Yang
Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial
Paul A. Matthews, Brigitte E. Scammell, Arfan Ali, Timothy Coughlin, Jessica Nightingale, Tanvir Khan, Ben J. Ollivere
A randomized phase 2B trial of vancomycin versus daptomycin for the treatment of methicillin-resistant Staphylococcus aureus bacteremia due to isolates with high vancomycin minimum inhibitory concentrations – results of a prematurely terminated study
Shirin Kalimuddin, Yvonne F. Z. Chan, Rachel Phillips, Siew Pei Ong, Sophia Archuleta, David Chien Lye, Thuan Tong Tan, Jenny G. H. Low
Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial
Julie M. Fritz, Jason A. Sharpe, Elizabeth Lane, Doug Santillo, Tom Greene, Gregory Kawchuk
Effects of dexmedetomidine on delirium duration of non-intubated ICU patients (4D trial): study protocol for a randomized trial
Clémence Louis, Thomas Godet, Gérald Chanques, Nathalie Bourguignon, Dominique Morand, Bruno Pereira, Jean-Michel Constantin
Comparing isolated soy protein with flaxseed oil vs isolated soy protein with corn oil and wheat flour with corn oil consumption on muscle catabolism, liver function, blood lipid, and sugar in burn patients: a randomized clinical trial
Siavash Babajafari, Abdollah Hojhabrimanesh, Zahra Sohrabi, Mehdi Ayaz, Ali Noorafshan, Atefeh Akrami
Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial
Terry Wahls, Maria O. Scott, Zaidoon Alshare, Linda Rubenstein, Warren Darling, Lucas Carr, Karen Smith, Catherine A. Chenard, Nicholas LaRocca, Linda Snetselaar
Effectiveness and sustainability of a structured group-based educational program (MEDIHEALTH) in improving medication adherence among Malay patients with underlying type 2 diabetes mellitus in Sarawak State of Malaysia: study protocol of a randomized controlled trial
Chuo Yew Ting, Shahren Ahmad Zaidi Adruce, Mohamed Azmi Hassali, Hiram Ting, Chien Joo Lim, Rachel Sing-Kiat Ting, Abu Hassan Alshaari Abd Jabar, Nor Anizah Osman, Izzul Syazwan Shuib, Shing Chyi Loo, Sui Theng Sim, Su Ee Lim, Donald E. Morisky
‘Test n Treat (TnT)’– Rapid testing and same-day, on-site treatment to reduce rates of chlamydia in sexually active further education college students: study protocol for a cluster randomised feasibility trial
Sarah Kerry-Barnard, Charlotte Fleming, Fiona Reid, Rachel Phillips, Vari M. Drennan, Elisabeth J. Adams, Wendy Majewska, Anjella Balendra, Emma Harding-Esch, Emma Cousins, S. Tariq Sadiq, Pippa Oakeshott
‘Test n Treat (TnT)’: a cluster-randomised feasibility trial of frequent, rapid-testing and same-day, on-site treatment to reduce rates of chlamydia in high-risk further education college students: statistical analysis plan
Rachel Phillips, Pippa Oakeshott, Sarah Kerry-Barnard, Fiona Reid
Strengthening intrapartum and immediate newborn care to reduce morbidity and mortality of preterm infants born in health facilities in Migori County, Kenya and Busoga Region, Uganda: a study protocol for a randomized controlled trial
Phelgona Otieno, Peter Waiswa, Elizabeth Butrick, Gertrude Namazzi, Kevin Achola, Nicole Santos, Ryan Keating, Felicia Lester, Dilys Walker
Efficacy of acupuncture on pelvic pain in patients with endometriosis: study protocol for a randomized, single-blind, multi-center, placebo-controlled trial
Ruining Liang, Peishuang Li, Xuemei Peng, Ling Xu, Pei Fan, Jiahua Peng, Xu Zhou, Chunlin Xiao, Miao Jiang
The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial
Lars Morso, Berit Schiøttz-Christensen, Jens Søndergaard, Nils-Bo de Vos Andersen, Flemming Pedersen, Kim Rose Olsen, Morten Sall Jensen, Jonathan Hill, David Høyrup Christiansen
Augmentation effect of acupuncture on Bi’nao for hypophasis in patients with Bell’s palsy: study protocol for a randomized controlled trial
Xiaoyan Li, Chunlan Chen, Chuang Zhao, Zunyuan Li, Wei Liang, Zhidan Liu
An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial
Anne Forster, Suzanne Hartley, Lorna Barnard, Seline Ozer, Natasha Hardicre, Tom Crocker, Marie Fletcher, Lauren Moreau, Ross Atkinson, Claire Hulme, Ivana Holloway, Laetitia Schmitt, Allan House, Jenny Hewison, Gillian Richardson, Amanda Farrin
Intravenous morphine versus intravenous paracetamol after cardiac surgery in neonates and infants: a study protocol for a randomized controlled trial
Gerdien A. Zeilmaker-Roest, Joost van Rosmalen, Monique van Dijk, Erik Koomen, Nicolaas J. G. Jansen, Martin C. J. Kneyber, Sofie Maebe, Greet van den Berghe, Dirk Vlasselaers, Ad J. J. C. Bogers, Dick Tibboel, Enno D. Wildschut
Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in preterm infants with respiratory distress syndrome: Study protocol for a multi-center prospective randomized controlled trial
Xing-Wang Zhu, Yuan Shi, Li-Ping Shi, Ling Liu, Jiang Xue, Rangasamy Ramanathan, Xing-Wang Zhu, Yuan Shi, Lei Bao, Cheng-Jun Liu, Li-Ping Shi, Jiang Xue, Rong Ju, Ling Liu, Xi-Rong Gao, Xiao-Yun Zhong, Hui-Qing Sun, Yang-Fang Li, Kun Du, Hong Cao, Zhao-qing Yin, Ming Yi, Jun Yan, Zhan-Kui Li, Wei-Wei Gao, Rui Cheng, Lai-Shuan Wang, Vladimiras Chijenas
Protecting Adolescents in Low- And Middle-Income Countries from Interpersonal Violence (PRO YOUTH TRIAL): Study Protocol for a Cluster Randomized Controlled Trial of the Strengthening Families Programme 10-14 (“Familias Fuertes”) in Panama
Anilena Mejia, Richard Emsley, Eleonora Fichera, Wadih Maalouf, Jeremy Segrott, Rachel Calam
A phase IIa proof-of-concept, placebo-controlled, randomized, double-blind, crossover, single-dose clinical trial of a new class of bronchodilator for acute asthma
Veronica Swystun, Francis H. Y. Green, John H. Dennis, Emmanouil Rampakakis, Gurkeet Lalli, Morenike Fadayomi, Andrea Chiu, Grishma Shrestha, Sharif Galal El Shahat, David Evan Nelson, Tamer Y. El Mays, Cora A. Pieron, Richard Leigh
Effectiveness of endoscopic totally extraperitoneal (TEP) hernia correction for clinically occult inguinal hernia (EFFECT): study protocol for a randomized controlled trial
Marleen M. Roos, Egbert-Jan M. M. Verleisdonk, Floris B. M. Sanders, Arno W. Hoes, Rebecca K. Stellato, Geert W. J. Frederix, Rogier K. J. Simmermacher, Josephina P. J. Burgmans, Marleen M. Roos, Coen V. van Hessen, Wouter J. Bakker, Egbert Jan M. M. Verleisdonk, Floris B. M. Sanders, Ine P. J. Burgmans, Rogier K. J. Simmermacher, Arno W. Hoes, Rebecca K. Stellato, Geert W. Frederix, Henk F. van Stel, Andre de Vries, Maarten P. Simons, Paul M. Verheijen, Caroline M. E. Contant, Johannes A. Wegdam, Gerrit D. Slooter, Huib A. Cense, Frank W. H. Kloppenberg
Follow-up study regarding the medium-term effectiveness of the home-visiting program “Pro Kind” at age 7 years: study protocol for a randomized controlled trial
Sören Kliem, Malte Sandner, Anna Lohmann, Susan Sierau, Verena Dähne, Annette M. Klein, Tanja Jungmann
S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial
Sang-Ho Jo, Sung-Ji Park, Eung Ju Kim, Soo-Joong Kim, Hyun-Jae Cho, Jong-Min Song, Jinho Shin, Jin Joo Park, Joon-Han Shin, Kyoo-Rok Han, Dong-Ju Choi
Aggression Following Traumatic brain injury: Effectiveness of Risperidone (AFTER): study protocol for a feasibility randomised controlled trial
Shoumitro Deb, Verity Leeson, Lina Aimola, Mayur Bodani, Lucia Li, Tim Weaver, David Sharp, Mike Crawford
Dexmedetomidine and intravenous acetaminophen for the prevention of postoperative delirium following cardiac surgery (DEXACET trial): protocol for a prospective randomized controlled trial
Puja Shankar, Ariel Mueller, Senthil Packiasabapathy, Doris Gasangwa, Melissa Patxot, Brian O’Gara, Shahzad Shaefi, Edward R. Marcantonio, Balachundhar Subramaniam
Qualitative analysis of feasibility of recruitment and retention in a planned randomised controlled trial of a psychosocial cancer intervention within the NHS
M. Duncan, A. Korszun, P. White, G. Eva, Kamaldeep Bhui, Liam Bourke, Trudie Chalder, Jennifer Deane, Sandra Eldridge, John Gribben, Louise Jones, Paul McCrone, Adrienne Morgan, Damien Ridge, Rebecca Roylance, Steph Taylor, Mohamed Thaha
Participation in a trial in the emergency situation: a qualitative study of patient experience in the UK WOLLF trial
Elizabeth Tutton, Juul Achten, Sarah E. Lamb, Keith Willett, Matthew L. Costa, Julie Bruce, Sonia Davis, Susie Hennings, Stavros Petrou, Steven Jeffery, Damian Griffin, Benjamin Parker, James Masters, Nick Parsons
Jugular vs femoral vein for central venous catheterization in pediatric cardiac surgery (PRECiSE): study protocol for a randomized controlled trial
Simona Silvetti, Tommaso Aloisio, Anna Cazzaniga, Marco Ranucci
Effects of an exercise program on hepatic metabolism, hepatic fat, and cardiovascular health in overweight/obese adolescents from Bogotá, Colombia (the HEPAFIT study): study protocol for a randomized controlled trial
Katherine González-Ruíz, Jorge Enrique Correa-Bautista, Mikel Izquierdo, Antonio García-Hermoso, María Andrea Dominguez-Sanchez, Rosa Helena Bustos-Cruz, Jorge Cañete García-Prieto, Vicente Martínez-Vizcaíno, Felipe Lobelo, Emilio González-Jiménez, Daniel Humberto Prieto-Benavides, Alejandra Tordecilla-Sanders, Jacqueline Schmidt-RioValle, Guillermo Perez, Robinson Ramírez-Vélez
Protocol, and practical challenges, for a randomised controlled trial comparing the impact of high intensity interval training against standard care before major abdominal surgery: study protocol for a randomised controlled trial
John Woodfield, Matthew Zacharias, Genevieve Wilson, Fran Munro, Kate Thomas, Andrew Gray, James Baldi
Tailoring and evaluating an intervention to improve shared decision-making among seniors with dementia, their caregivers, and healthcare providers: study protocol for a randomized controlled trial
Anik M. C. Giguere, Moulikatou Adouni Lawani, Émilie Fortier-Brochu, Pierre-Hugues Carmichael, France Légaré, Edeltraut Kröger, Holly O. Witteman, Philippe Voyer, Danielle Caron, Charo Rodríguez
Speech-guided breathing retraining in asthma: a randomised controlled crossover trial in real-life outpatient settings
Dietrich von Bonin, Sabine D. Klein, Jana Würker, Eva Streit, Oliver Avianus, Christian Grah, Jörg Salomon, Ursula Wolf
Accommodating quality and service improvement research within existing ethical principles
Cory E. Goldstein, Charles Weijer, Jamie C. Brehaut, Marion Campbell, Dean A. Fergusson, Jeremy M. Grimshaw, Karla Hemming, Austin R. Horn, Monica Taljaard
Liuzijue Qigong vs traditional breathing training for patients with post-stroke dysarthria complicated with abnormal respiratory control: study protocol of a single center randomized controlled trial
Hongli Li, Gaiyan Li, Gongliang Liu, Ying Zhang
Efficacy and mechanism of sub-sensory sacral (optimised) neuromodulation in adults with faecal incontinence: study protocol for a randomised controlled trial
Eleanor McAlees, Paul F. Vollebregt, Natasha Stevens, Tom C. Dudding, Anton V. Emmanuel, Paul L. Furlong, Shaheen Hamdy, Richard L. Hooper, James F. X. Jones, Christine Norton, P. Ronan O’Connell, S. Mark Scott, Charles H. Knowles
Mechanisms and modulators of cognitive training gain transfer in cognitively healthy aging: study protocol of the AgeGain study
Dominik Wolf, Oliver Tüscher, Stefan Teipel, Andreas Mierau, Heiko Strüder, Alexander Drzezga, Bernhard Baier, Harald Binder, Andreas Fellgiebel, Andreas Fellgiebel, Oliver Tüscher, Bernhard Baier, Dominik Wolf, Bianca Kollmann, Florian Fischer, Alexandra Sebastian, Heiko Strüder, Andreas Mierau, Kristel Knaepen, David Riedel, Alexander Drzezga, Stefan Teipel, Katharina Brüggen, Judith Henf, Esther Lau, Harald Binder
Crossbow needle therapy of the Miao ethnic minority group for knee osteoarthritis: study protocol for a randomized controlled trial
Jing Fu, Hong-cai Shang, Li-ying Wang, Chen Zhao, Jin Cui, Yan-ping Wang
Exploring and adjusting for potential learning effects in ROLARR: a randomised controlled trial comparing robotic-assisted vs. standard laparoscopic surgery for rectal cancer resection
Neil Corrigan, Helen Marshall, Julie Croft, Joanne Copeland, David Jayne, Julia Brown
Treatment of voluminous and complicated superficial slow-flow vascular malformations with sirolimus (PERFORMUS): protocol for a multicenter phase 2 trial with a randomized observational-phase design
Annabel Maruani, Olivia Boccara, Didier Bessis, Laurent Guibaud, Pierre Vabres, Juliette Mazereeuw-Hautier, Sébastien Barbarot, Christine Chiaverini, Sophie Blaise, Catherine Droitcourt, Stéphanie Mallet, Ludovic Martin, Gérard Lorette, Jean-Baptiste Woillard, Annie-Pierre Jonville-Bera, Jérome Rollin, Yves Gruel, Denis Herbreteau, Dominique Goga, Anne le Touze, Sophie Leducq, Valérie Gissot, Baptiste Morel, Elsa Tavernier, Bruno Giraudeau
Automated recruitment and randomisation for an efficient randomised controlled trial in primary care
Victoria R. Cornelius, Lisa McDermott, Alice S. Forster, Mark Ashworth, Alison J. Wright, Martin C. Gulliford
Comparison of the effectiveness between transcutaneous electrical nerve stimulation, manual acupuncture, and electroacupuncture on tinnitus: study protocol for a randomized controlled trial
Young-Kyun Moon, Min Hee Kim, Hae Jeong Nam
Psychological distress following a motor vehicle crash: preliminary results of a randomised controlled trial investigating brief psychological interventions
Rebecca Guest, Yvonne Tran, Bamini Gopinath, Ian D. Cameron, Ashley Craig
Evaluating parents’ decisions about next-generation sequencing for their child in the NC NEXUS (North Carolina Newborn Exome Sequencing for Universal Screening) study: a randomized controlled trial protocol
Laura V. Milko, Christine Rini, Megan A. Lewis, Rita M. Butterfield, Feng-Chang Lin, Ryan S. Paquin, Bradford C. Powell, Myra I. Roche, Katherine J. Souris, Donald B. Bailey Jr, Jonathan S. Berg, Cynthia M. Powell
Effects of pre-transplant azithromycin administration on kidney graft function: study protocol for a double-blind randomized clinical trial
Gholamreza Mokhtari, Mojtaba Teimoori
Long-term Staphylococcus aureus decolonization in patients on home parenteral nutrition: study protocol for a randomized multicenter trial
Michelle Gompelman, Yannick Wouters, Wietske Kievit, Joost Hopman, Heiman F. Wertheim, Chantal P. Bleeker-Rovers, Geert J. A. Wanten
Effects of a 6-week, whole-body vibration strength-training on depression symptoms, endocrinological and neurobiological parameters in adolescent inpatients experiencing a major depressive episode (the “Balancing Vibrations Study”): study protocol for a randomized placebo-controlled trial
Max Oberste, Nicola Großheinrich, Heidrun-Lioba Wunram, Johannes Levin Graf, Alischa Ziemendorff, Axel Meinhardt, Oliver Fricke, Esther Mahabir, Stephan Bender
Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial
Siyi Yu, Yueqiang Wen, Wanting Xia, Mingxiao Yang, Zhengtao Lv, Xiaoji Li, Wenyao Li, Sha Yang, Youping Hu, Fanrong Liang, Jie Yang
Acceptability of the method of administration of a patient-reported outcome measure (PROM) with stroke survivors, a randomised controlled trial protocol
Alexander Smith, Anna Pennington, Ben Carter, Stephanie Gething, Michelle Price, James White, Richard Dewar, Jonathan Hewitt
The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer®) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial
Seung Hyun Lee, Jae-Kwang Shim, Sarah Soh, Jong Wook Song, Byung Chul Chang, Sak Lee, Young-Lan Kwak
Towards a health-enabling working environment - developing and testing interventions to decrease HIV and TB stigma among healthcare workers in the Free State, South Africa: study protocol for a randomised controlled trial
Asta Rau, Edwin Wouters, Michelle Engelbrecht, Caroline Masquillier, Kerry Uebel, Gladys Kigozi, Nina Sommerland, André Janse van Rensburg
The caries-arresting effect of incorporating functionalized tricalcium phosphate into fluoride varnish applied following application of silver nitrate solution in preschool children: study protocol for a randomized, double-blind clinical trial
Kitty Jieyi Chen, Sherry Shiqian Gao, Duangporn Duangthip, Edward Chin Man Lo, Chun Hung Chu
Healthy Campus Trial: a multiphase optimization strategy (MOST) fully factorial trial to optimize the smartphone cognitive behavioral therapy (CBT) app for mental health promotion among university students: study protocol for a randomized controlled trial
Teruhisa Uwatoko, Yan Luo, Masatsugu Sakata, Daisuke Kobayashi, Yu Sakagami, Kazumi Takemoto, Linda M. Collins, Ed Watkins, Steven D. Hollon, James Wason, Hisashi Noma, Masaru Horikoshi, Takashi Kawamura, Taku Iwami, Toshi A. Furukawa
Safe Birth and Cultural Safety in southern Mexico: study protocol for a randomised controlled trial
Iván Sarmiento, Sergio Paredes-Solís, Neil Andersson, Anne Cockcroft
Efficacy of Jia Wei Yang He formula as an adjunctive therapy for asthma: study protocol for a randomized, double blinded, controlled trial
Wenhan Jiang, Zifeng Ma, Huiyong Zhang, Henry S. Lynn, Beiqi Xu, Xiao Zhang, Rongrong Bi, Jiyou Fu, Yue Chen, Zhen Xiao, Zhijie Zhang, Zhenhui Lu
Acupuncture as an early treatment for idiopathic sudden sensorineural hearing loss (ISSNHL) patients with flat or high-frequency drop audiograms: study protocol for a randomized controlled trial
Kai Shang, Xin Ma, Hui-Lin Liu, Yuan-Yuan Jing, Lin Zeng, Nan Li, De-An Zhou, Jia Wei, Chen Zhang
Open-label randomized controlled trial to compare wound dressings for patients undergoing hip and knee arthroplasty: study protocol for a randomized controlled trial
Maria López-Parra, Dolors Gil-Rey, Esmeralda López-González, Eva-Maria González-Rodríguez, Isabel Simó-Sánchez, Francisco Zamora-Carmona, Lidia Roqueta-Andreu, Marta Arizu-Puigvert, Dolors Abril-Sabater, Àngels Moreno-Álvarez, Àngels López-Bonet, Gisela López-Hidalgo, Helena Costa-Ventura, Laura García-Pardo, Mireia Rico-Liberato, Miriam García-Borràs, Maria Teresa Arnal-Leris, Mònica Sianes-Gallén, Roser Vives
Achieving optimal technology and behavioral uptake of single and combined interventions of water, sanitation hygiene and nutrition, in an efficacy trial (WASH benefits) in rural Bangladesh
Sarker Masud Parvez, Rashidul Azad, Mahbubur Rahman, Leanne Unicomb, Pavani K. Ram, Abu Mohd Naser, Christine P. Stewart, Kaniz Jannat, Musarrat Jabeen Rahman, Elli Leontsini, Peter J. Winch, Stephen P. Luby
WASH Benefits Bangladesh trial: management structure for achieving high coverage in an efficacy trial
Leanne Unicomb, Farzana Begum, Elli Leontsini, Mahbubur Rahman, Sania Ashraf, Abu Mohd Naser, Fosiul A. Nizame, Kaniz Jannat, Faruqe Hussain, Sarker Masud Parvez, Shaila Arman, Moshammot Mobashara, Stephen P. Luby, Peter J. Winch
WASH Benefits Bangladesh trial: system for monitoring coverage and quality in an efficacy trial
Mahbubur Rahman, Sania Ashraf, Leanne Unicomb, A. K. M. Mainuddin, Sarker Masud Parvez, Farzana Begum, Kishor Kumar Das, Abu Mohd. Naser, Faruqe Hussain, Thomas Clasen, Stephen P. Luby, Elli Leontsini, Peter J. Winch
Comparison of cold and hot snaring polypectomy for small colorectal polyps: study protocol for a randomized controlled trial
Yen-Nien Chen, Li-Chun Chang, Chi-Yang Chang, Peng-Jen Chen, Chi-Yi Chen, Cheng-Hao Tseng, Han-Mo Chiu
Effects of hemodynamic monitoring using a single-use transesophageal echocardiography probe in critically ill patients – study protocol for a randomized controlled trial
Luca Cioccari, Bjoern Zante, Andreas Bloch, David Berger, Andreas Limacher, Stephan M. Jakob, Jukka Takala, Tobias M. Merz
Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial
Richard Y. Cao, Hongchao Zheng, Qiongyao Mi, Qing Li, Wenchao Yuan, Yueyou Ding, Jian Yang
The impact of an exercise training intervention on cortisol levels and post-traumatic stress disorder in juveniles from an Ugandan refugee settlement: study protocol for a randomized control trial
Henning Budde, Davin P. Akko, Herbert E. Ainamani, Eric Murillo-Rodríguez, Roland Weierstall
Planning a future randomized clinical trial based on a network of relevant past trials
Georgia Salanti, Adriani Nikolakopoulou, Alex J. Sutton, Stephan Reichenbach, Sven Trelle, Huseyin Naci, Matthias Egger
Improving cardiovascular health and quality of life in people with severe mental illness: study protocol for a randomised controlled trial
Malcolm Battersby, Michael R. Kidd, Julio Licinio, Philip Aylward, Amanda Baker, Julie Ratcliffe, Stephen Quinn, David J. Castle, Sara Zabeen, A. Kate Fairweather-Schmidt, Sharon Lawn
Efficacy and indication optimization of Chinese medicine (Tiao-Chang Ke-Min granules) for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial
Qian Li, Bei-ping Zhang, Shao-gang Huang, Wen-wei Ouyang, Jian-hui Xie, Ze-huai Wen, Xiao-bo Yang
An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial
Natasha K. Hardicre, Thomas F Crocker, Alan Wright, Louisa-Jane Burton, Seline Ozer, Ross Atkinson, Allan House, Jenny Hewison, Christopher McKevitt, Anne Forster, Amanda J. Farrin
Splenic vein resection together with the pancreatic parenchyma versus separated resection after isolation of the parenchyma during distal pancreatectomy (COSMOS-DP trial): study protocol for a randomised controlled trial
Suguru Yamada, Tsutomu Fujii, Manabu Kawai, Toshio Shimokawa, Masafumi Nakamura, Yoshiaki Murakami, Sohei Satoi, Hidetoshi Eguchi, Yuichi Nagakawa, Yasuhiro Kodera, Hiroki Yamaue
Novel PAradigm to improve Inflammatory burden in end stage Renal disease (rePAIR): study protocol for a randomized controlled trial
Ruchir Trivedi, George Fares, Victoria Barany Nunez, Ryan Campbell, Megyn Clement, Joseph Burleson, Jonathan Himmelfarb, Effie Ioannidou
Personalised relaxation practice to improve sleep and functioning in patients with chronic fatigue syndrome and depression: study protocol for a randomised controlled trial
Claire L. Macnamara, Erin Cvejic, Gordon B. Parker, Andrew R. Lloyd, Gina Lee, Jessica E. Beilharz, Ute Vollmer-Conna
Low-level laser therapy for treatment of venous ulcers evaluated with the Nursing Outcome Classification: study protocol for a randomized controlled trial
Taline Bavaresco, Ananda Ughini Bertoldo Pires, Vítor Monteiro Moraes, Viviane Maria Osmarin, Denise Tolfo Silveira, Amália de Fátima Lucena
The central mechanism of acupuncture treatment with a long-lasting effect for functional dyspepsia: study protocol for a randomized controlled trial
Ruirui Sun, Xiaojuan Hong, Jing Guo, Shuai Yin, Peiming Feng, Lei Lan, Du Lei, Xiaoyan Liu, Xueling Suo, Tao Yin, Tingting Zhang, Liuyang Huang, Feifei Gao, Qiyong Gong, Fanrong Liang, Fang Zeng
The outcomes of Perthes’ disease of the hip: a study protocol for the development of a core outcome set
Donato Giuseppe Leo, Wei Yee Leong, Tina Gambling, Andrew Long, Rebecca Murphy, Helen Jones, Daniel Christopher Perry
Safety and Optimal Neuroprotection of neu2000 in acute Ischemic stroke with reCanalization: study protocol for a randomized, double-blinded, placebo-controlled, phase-II trial
Ji Man Hong, Mun Hee Choi, Sung-Il Sohn, Yang-Ha Hwang, Seong Hwan Ahn, Yeong-Bae Lee, Dong-Ick Shin, Ángel Chamorro, Dennis W. Choi, Ji Man Hong, Sung-Il Sohn, Yang-Ha Hwang, Seong Hwan Ahn, Yeong-Bae Lee, Dong-Ick Shin, Dennis W. Choi, Eung Yeop Kim, Jin Soo Lee, Jin Wook Choi, Dong Hoon Shin, Min-Ju Yeo, Jaehyuk Kwak, Sung Eun Lee, Jeong-Ho Hong, Sangkil Lee, Yoon-Joo Lee, Min-Joo Lee
Effectiveness and safety of acupuncture for elderly overactive bladder population in Hong Kong: study protocol for a randomized controlled trial
Yu Tat Chan, Hong Wei Zhang, Yuan Qi Guo, Tony Ngai Ho Chan, Yiu-Keung Kwan, Chun-Kam Lee, Kit Ngan, Zhi-Xiu Lin
Hand-Assisted laparoscopic donor nephrectomy PERiumbilical versus Pfannenstiel incision and return to normal physical ACTivity (HAPERPACT): study protocol for a randomized controlled trial
Yakup Kulu, Beat P. Müller-Stich, Omid Ghamarnejad, Elias Khajeh, Georgios Polychronidis, Mohammad Golriz, Felix Nickel, Laura Benner, Philipp Knebel, Markus Diener, Christian Morath, Martin Zeier, Markus W. Büchler, Arianeb Mehrabi
Learning from OCTET – exploring the acceptability of clinical trials management methods
Catherine Arundel, Judith Gellatly
Use of monomeric and oligomeric flavanols in the dietary management of patients with type 2 diabetes mellitus and microalbuminuria (FLAVA trial): study protocol for a randomized controlled trial
Mardin Rashid, Adrie J. M. Verhoeven, Monique T. Mulder, Reinier Timman, Yvonne van Beek-Nieuwland, Athumani A. Athumani, Adrienne A. M. Zandbergen, Hans E. van der Wiel, Eric J. G. Sijbrands, Kirsten A. Berk
SEALIVE: the use of technical vessel-sealing devices for recipient hepatectomy in liver transplantation: study protocol for a randomized controlled trial
Philipp Houben, Elias Khajeh, Ulf Hinz, Phillip Knebel, Markus K. Diener, Arianeb Mehrabi
Baduanjin exercise for patients with ischemic heart failure on phase-II cardiac rehabilitation (BEAR trial): study protocol for a prospective randomized controlled trial
Meili Yu, Siming Li, Siwei Li, Jingen Li, Hao Xu, Keji Chen
Preventing false discovery of heterogeneous treatment effect subgroups in randomized trials
Joseph Rigdon, Michael Baiocchi, Sanjay Basu
Community-based provision of direct-acting antiviral therapy for hepatitis C: study protocol and challenges of a randomized controlled trial
A. J. Wade, J. S. Doyle, E. Gane, C. Stedman, B. Draper, D. Iser, S. K. Roberts, W. Kemp, D. Petrie, N. Scott, P. Higgs, P. A. Agius, J. Roney, L. Stothers, A. J. Thompson, M. E. Hellard
Prophylactic intravitreal 5-fluorouracil and heparin to prevent proliferative vitreoretinopathy in high-risk patients with retinal detachment: study protocol for a randomized controlled trial
Friederike Schaub, Robert Hoerster, Petra Schiller, Moritz Felsch, Daria Kraus, Marouan Zarrouk, Bernd Kirchhof, Sascha Fauser
Hypertension management for community-dwelling older people with diabetes in Nanchang, China: study protocol for a cluster randomized controlled trial
Qiang Tu, Lily Dongxia Xiao, Shahid Ullah, Jeffrey Fuller, Huiyun Du
Effect of transcranial direct current stimulation associated with hypocaloric diet on weight loss and metabolic profile in overweight or obesity: study protocol for a double-blind, randomized controlled clinical trial
Carina de Araujo, Raquel Crespo Fitz, Daniela Albugeri Nogara, Pedro Schestatsky, Fernando Gerchman
Concurrent exergaming and transcranial direct current stimulation to improve balance in people with Parkinson’s disease: study protocol for a randomised controlled trial
Dale M. Harris, Timo Rantalainen, Makii Muthalib, Liam Johnson, Rachel L. Duckham, Stuart T. Smith, Robin M. Daly, Wei-Peng Teo
Whole brain radiation therapy alone versus radiosurgery for patients with 1–10 brain metastases from small cell lung cancer (ENCEPHALON Trial): study protocol for a randomized controlled trial
Denise Bernhardt, Adriane Hommertgen, Daniela Schmitt, Rami El Shafie, Angela Paul, Laila König, Johanna Mair-Walther, Johannes Krisam, Christina Klose, Thomas Welzel, Juliane Hörner-Rieber, Jutta Kappes, Michael Thomas, Claus Peter Heußel, Martin Steins, Meinhard Kieser, Jürgen Debus, Stefan Rieken
Effects of traditional Chinese herbal medicine in patients with diabetic kidney disease: study protocol for a randomized controlled trial
Mengdi Wang, Zhen Wang, Jingwei Zhou, Weiwei Sun, Ying Wang, Mei Han, Hanwen Yang, Wei Jing Liu, Yaoxian Wang
Randomized Embolization Trial for NeuroEndocrine Tumor Metastases to the Liver (RETNET): study protocol for a randomized controlled trial
James X. Chen, E. Paul Wileyto, Michael C. Soulen
Effect of preconceptional orlistat treatment on in-vitro fertilization outcome in overweight/obese women: study protocol for a randomized controlled trial
Jing Li, Ze Wang, Daimin Wei, Hong Liu, Jiangtao Zhang, Jianfeng Wang, Yuhua Shi, Zi-Jiang Chen
Effects of small-dose remifentanil combined with index of consciousness monitoring on gastroscopic polypectomy: a prospective, randomized, single-blinded trial
Minqiang Liu, Hongyan Wu, Danling Yang, Fengxian Li, Zhichao Li, Song Wang, Renliang He
Correction to: Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial
Sasha-Denise Grünzig, Harald Baumeister, Jürgen Bengel, David Ebert, Lena Krämer
Engaging family supporters of adult patients with diabetes to improve clinical and patient-centered outcomes: study protocol for a randomized controlled trial
Ann-Marie Rosland, John D. Piette, Ranak Trivedi, Eve A. Kerr, Shelley Stoll, Adam Tremblay, Michele Heisler
Prophylactic antibiotics for the prevention of infection following operative vaginal delivery (ANODE): study protocol for a randomised controlled trial
Marian Knight, Linda Mottram, Shan Gray, Christopher Partlett, Ed Juszczak, Marian Knight, Helen Enderby, Derek Tuffnell, Kim Hinshaw, Ranee Thakar, Abdul H. Sultan, Julia Sanders, Dharmintra Pasupathy, Philip Moore, James Gray, Oliver Rivero-Arias, Ed Juszczak, Louise Linsell, Aethele Khunda
Physician-delivered motivational interviewing to improve adherence and retention in care among challenging HIV-infected patients in Argentina (COPA2): study protocol for a cluster randomized controlled trial
Omar Sued, Isabel Cassetti, Diego Cecchini, Pedro Cahn, Lina Bofill de Murillo, Stephen M. Weiss, Lissa N. Mandell, Manasi Soni, Deborah L. Jones
The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening: study protocol for a randomised controlled trial
Jennifer G. Walker, Finlay Macrae, Ingrid Winship, Jasmeen Oberoi, Sibel Saya, Shakira Milton, Adrian Bickerstaffe, James G. Dowty, Richard De Abreu Lourenço, Malcolm Clark, Louise Galloway, George Fishman, Fiona M. Walter, Louisa Flander, Patty Chondros, Driss Ait Ouakrim, Marie Pirotta, Lyndal Trevena, Mark A. Jenkins, Jon D. Emery
Evaluation of a medication monitor-based treatment strategy for drug-sensitive tuberculosis patients in China: study protocol for a cluster randomised controlled trial
James J. Lewis, Xiaoqiu Liu, Zhiying Zhang, Bruce V. Thomas, Anna Vassall, Sedona Sweeney, Xu Caihong, Hu Dongmei, Li Xue, Gao Yongxin, Shitong Huan, Jiang Shiwen, Katherine L. Fielding
Comparing satisfaction with a participatory driven web-application and a standard website for patients with low back pain: a study protocol for a randomised controlled trial (part of the ADVIN Back Trial)
Allan Riis, Jan Hartvigsen, Michael Skovdal Rathleff, Tamana Afzali, Martin Bach Jensen
Improving empathy and self-efficacy in caregivers of persons with intellectual disabilities, using m-learning (HiSense APP-ID): study protocol for a randomized controlled trial
Evelien van Wingerden, Paula S. Sterkenburg, Mirjam Wouda
Palliative long-term abdominal drains versus repeated drainage in individuals with untreatable ascites due to advanced cirrhosis: study protocol for a feasibility randomised controlled trial
Lucia Macken, Louise Mason, Catherine Evans, Heather Gage, Jake Jordan, Mark Austin, Nick Parnell, Max Cooper, Shani Steer, Justine Boles, Stephen Bremner, Debbie Lambert, David Crook, Gemma Earl, Jean Timeyin, Sumita Verma
High flow nasal oxygen after bariatric surgery (OXYBAR), prophylactic post-operative high flow nasal oxygen versus conventional oxygen therapy in obese patients undergoing bariatric surgery: study protocol for a randomised controlled pilot trial
Rachel Fulton, Jonathan E. Millar, Megan Merza, Helen Johnston, Amanda Corley, Daniel Faulke, Ivan Rapchuk, Joe Tarpey, Philip Lockie, Shirley Lockie, John F. Fraser
Moxibustion using different habitat moxa floss for moderate to severe primary knee osteoarthritis: study protocol for a three-armed randomized, double-blinded, sham-controlled trial
Huanfang Xu, Hong Zhao, Liping Kang, Shixi Huang, Yin Shi, Wei Su, Mingjuan Han, Wenyan Wang, Chunyan Wang, Yuan Zhang, Lanping Guo
The age of blood in pediatric intensive care units (ABC PICU): study protocol for a randomized controlled trial
Marisa Tucci, Jacques Lacroix, Dean Fergusson, Allan Doctor, Paul Hébert, Robert A. Berg, Jaime Caro, Cassandra D. Josephson, Stéphane Leteurtre, Kusum Menon, Kenneth Schechtman, Marie E. Steiner, Alexis F. Turgeon, Lucy Clayton, Tina Bockelmann, Philip C. Spinella
Yoga and breathing technique training in patients with heart failure and preserved ejection fraction: study protocol for a randomized clinical trial
Carla Pinheiro Lopes, Luiz Claudio Danzmann, Ruy Silveira Moraes, Paulo José Cardoso Vieira, Francisco França Meurer, Douglas Santos Soares, Gaspar Chiappa, Luciano Santos Pinto Guimarâes, Santiago Alonso Tobar Leitão, Jorge Pinto Ribeiro, Andreia Biolo
CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials
Sean Grant, Evan Mayo-Wilson, Paul Montgomery, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, J. Lawrence Aber, Doug Altman, Kamaldeep Bhui, Andrew Booth, David Clark, Peter Craig, Manuel Eisner, Mark W. Fraser, Frances Gardner, Sean Grant, Larry Hedges, Steve Hollon, Sally Hopewell, Robert Kaplan, Peter Kaufmann, Spyros Konstantopoulos, Geraldine Macdonald, Evan Mayo-Wilson, Kenneth McLeroy, Susan Michie, Brian Mittman, David Moher, Paul Montgomery, Arthur Nezu, Lawrence Sherman, Edmund Sonuga-Barke, James Thomas, Gary VandenBos, Elizabeth Waters, Robert West, Joanne Yaffe
Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension
Paul Montgomery, Sean Grant, Evan Mayo-Wilson, Geraldine Macdonald, Susan Michie, Sally Hopewell, David Moher, J. Lawrence Aber, Doug Altman, Kamaldeep Bhui, Andrew Booth, David Clark, Peter Craig, Manuel Eisner, Mark W. Fraser, Frances Gardner, Sean Grant, Larry Hedges, Steve Hollon, Sally Hopewell, Robert Kaplan, Peter Kaufmann, Spyros Konstantopoulos, Geraldine Macdonald, Evan Mayo-Wilson, Kenneth McLeroy, Susan Michie, Brian Mittman, David Moher, Paul Montgomery, Arthur Nezu, Lawrence Sherman, Edmund Sonuga-Barke, James Thomas, Gary VandenBos, Elizabeth Waters, Robert West, Joanne Yaffe
Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC)
Nefyn H. Williams, Alison Jenkins, Nia Goulden, Zoe Hoare, Dyfrig A. Hughes, Eifiona Wood, Nadine E. Foster, David Walsh, Dawn Carnes, Valerie Sparkes, Elaine M. Hay, John Isaacs, Kika Konstantinou, Dylan Morrissey, Jaro Karppinen, Stephane Genevay, Clare Wilkinson
Robotic versus laparoscopic gastrectomy with lymph node dissection for gastric cancer: study protocol for a randomized controlled trial
Toshiyasu Ojima, Masaki Nakamura, Mikihito Nakamori, Keiji Hayata, Masahiro Katsuda, Junya Kitadani, Shimpei Maruoka, Toshio Shimokawa, Hiroki Yamaue
Comparison of registered and published intervention fidelity assessment in cluster randomised trials of public health interventions in low- and middle-income countries: systematic review
Myriam Cielo Pérez, Nanor Minoyan, Valéry Ridde, Marie-Pierre Sylvestre, Mira Johri
Improving work for the body – a participatory ergonomic intervention aiming at reducing physical exertion and musculoskeletal pain among childcare workers (the TOY-project): study protocol for a wait-list cluster-randomized controlled trial
Charlotte Diana Nørregaard Rasmussen, Peter Rasmus Hendriksen, Malene Jagd Svendsen, Dorte Ekner, Klaus Hansen, Ole Henning Sørensen, Susanne Wulff Svendsen, Allard J. van der Beek, Andreas Holtermann
The effect of SODIS water treatment intervention at the household level in reducing diarrheal incidence among children under 5 years of age: a cluster randomized controlled trial in Dabat district, northwest Ethiopia
Bikes Destaw Bitew, Yigzaw Kebede Gete, Gashaw Andargie Biks, Takele Tadesse Adafrie
Assessment of the effect of addition of 24 hours of oral tranexamic acid post-operatively to a single intraoperative intravenous dose of tranexamic acid on calculated blood loss following primary hip and knee arthroplasty (TRAC-24): a study protocol for a randomised controlled trial
Janet Hill, Paul Magill, Alastair Dorman, Rosemary Hogg, Andrew Eggleton, Gary Benson, Margaret McFarland, Lynn Murphy, Evie Gardner, Leeann Bryce, Una Martin, Catherine Adams, Jennifer Bell, Christina Campbell, Ashley Agus, Glenn Phair, Dennis Molloy, Brian Mockford, Seamus O’Hagan, David Beverland
Cognitive behavioral intervention via a smartphone app for non-professional caregivers with depressive symptoms: study protocol for a randomized controlled trial
Fernando L. Vázquez, Ángela Torres, Olga Díaz, Mario Páramo, Patricia Otero, Vanessa Blanco, Lara López
Electronic nicotine devices to aid smoking cessation by alcohol- and drug-dependent clients: protocol for a pilot randomised controlled trial
Ashleigh Guillaumier, Victoria Manning, Olivia Wynne, Coral Gartner, Ron Borland, Amanda L. Baker, Catherine J. Segan, Eliza Skelton, Lyndell Moore, Ramez Bathish, Dan I. Lubman, Billie Bonevski
Combined pretreatment with 18F-FDG PET/CT and Comet assay guides the concurrent chemoradiotherapy of locally advanced cervical cancer: study protocol for a randomized controlled trial
Shengjun Ji, Qunchao Hu, Jiahao Zhu, Jie Chen, Qingqing Chen, Zhengcao Liu, Chen Shen, Ru Yang, Haoyao Sun, Jinchang Wu, Ke Gu
Gender-specific HIV and substance abuse prevention strategies for South African men: study protocol for a randomized controlled trial
Mary Jane Rotheram-Borus, Mark Tomlinson, Andile Mayekiso, Jason Bantjes, Danielle M. Harris, Jacqueline Stewart, Robert E. Weiss
Testing the effectiveness and implementation of a brief version of the Common Elements Treatment Approach (CETA) in Ukraine: a study protocol for a randomized controlled trial
Laura K. Murray, Emily E. Haroz, Benjamin Doty, Namrita S. Singh, Sergey Bogdanov, Judith Bass, Shannon Dorsey, Paul Bolton
Patient understanding and acceptability of an early lung cancer diagnosis trial: a qualitative study
Hayley C. Prout, Allan Barham, Emily Bongard, Rhiannon Tudor-Edwards, Gareth Griffiths, Willie Hamilton, Emily Harrop, Kerry Hood, Chris N. Hurt, Rosie Nelson, Catherine Porter, Kirsty Roberts, Trevor Rogers, Emma Thomas-Jones, Angela Tod, Seow Tien Yeo, Richard D. Neal, Annmarie Nelson
Evaluating the impact of Marie Stopes International’s digital family planning counselling application on the uptake of long-acting and permanent methods of contraception in Vietnam and Ethiopia: a study protocol for a multi-country cluster randomised controlled trial
Laura A. Bates, Joseph P. Hicks, John Walley, Emily Robinson
Statistical analysis plan for the Healthy Hands Project; single centre cluster-randomised clinical trial of a skin care program for the prevention of contact dermatitis in health care workers
Maryam Soltanipoor, Sanja Kezic, Judith Sluiter, Rebecca Holman
Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers (ENABLE CHF-PC): study protocol for a randomized controlled trial
Rachel Wells, Macy L. Stockdill, J. Nicholas Dionne-Odom, Deborah Ejem, Kathryn L. Burgio, Raegan W. Durant, Sally Engler, Andres Azuero, Salpy V. Pamboukian, Jose Tallaj, Keith M. Swetz, Elizabeth Kvale, Rodney O. Tucker, Marie Bakitas
Strengthening mental health and research training in Sub-Saharan Africa (SMART Africa): Uganda study protocol
Fred M. Ssewamala, Ozge Sensoy Bahar, Mary M. McKay, Kimberly Hoagwood, Keng-Yen Huang, Beverly Pringle
Dose-response relationship of core-specific sensorimotor interventions in healthy, well-trained participants: study protocol for a (MiSpEx) randomized controlled trial
Juliane Mueller, Josefine Stoll, Steffen Mueller, Frank Mayer
Improving physical activity, pain and function in patients waiting for hip and knee arthroplasty by combining targeted exercise training with behaviour change counselling: study protocol for a randomised controlled trial
Jane O’Brien, Kyra Hamilton, Andrew Williams, James Fell, Jonathan Mulford, Michael Cheney, Sam Wu, Marie-Louise Bird
Effects of ultrasound-guided stellate ganglion block on cervical vascular blood flow: study protocol for a randomized controlled trial
Shaofeng Pu, Jie Chen, Xing Gu, Yongming Xu, Junzhen Wu, Yingying Lv, Dongping Du
Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 Diabetes (SCORE-IT): study protocol for the development of a core outcome set
Nicola L. Harman, John Wilding, Dave Curry, James Harris, Jennifer Logue, R. John Pemberton, Leigh Perreault, Gareth Thompson, Sean Tunis, Paula R. Williamson, Serena Battaglia, Jacques Demotes-Mainard, Valerie Gailus-Durner, Silvio Garattini, Cecilia A. C. Prinsen, Michael Raess, Patricia da Silva-Buttkus, Caroline B. Terwee
Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial
Amjad Belramman, Roshan Bootun, Tjun Yip Tang, Tristan R. A. Lane, Alun H. Davies
m-Power Heart Project - a nurse care coordinator led, mHealth enabled intervention to improve the management of hypertension in India: study protocol for a cluster randomized trial
Nikhil Srinivasapura Venkateshmurthy, Vamadevan S Ajay, Sailesh Mohan, Devraj Jindal, Shuchi Anand, Dimple Kondal, Nikhil Tandon, Malipeddi Bhaskara Rao, Dorairaj Prabhakaran
Correction to: Survey indicated that core outcome set development is increasingly including patients, being conducted internationally and using Delphi surveys
Alice M. Biggane, Lucy Brading, Philippe Ravaud, Bridget Young, Paula R. Williamson
Whey protein supplementation for the preservation of mass and muscular strength of patients with heart failure: study protocol for a randomized controlled trial
Elisa Maia dos Santos, Roger de Moraes, Eduardo Vera Tibiriça, Grazielle Vilas Bôas Huguenin, Annie Seixas Belo Moreira, Andrea Rocha De Lorenzo
Prospective randomized controlled trial to compare laparoscopic distal gastrectomy (D2 lymphadenectomy plus complete mesogastrium excision, D2 + CME) with conventional D2 lymphadenectomy for locally advanced gastric adenocarcinoma: study protocol for a randomized controlled trial
Jie Shen, Beibei Cao, Yatao Wang, Aitang Xiao, Jichao Qin, Jianhong Wu, Qun Yan, Yuanlong Hu, Chuanyong Yang, Zhixin Cao, Junbo Hu, Ping Yin, Daxing Xie, Jianping Gong
0Phobia – towards a virtual cure for acrophobia: study protocol for a randomized controlled trial
T. Donker, S. Van Esveld, N. Fischer, A. Van Straten
Using acute tryptophan depletion to investigate predictors of treatment response in adolescents with major depressive disorder: study protocol for a randomised controlled trial
Richard M. Stewart, Sean D. Hood, Pradeep Rao, Julia K. Moore, Kevin C. Runions, Susannah E. Murphy, Janice W. Y. Wong, Florian D. Zepf
Reducing violence against children by implementing the preventative intervention Interaction Competencies with Children for Teachers (ICC-T): study protocol for a cluster randomized controlled trial in Southwestern Uganda
Joseph Ssenyonga, Katharin Hermenau, Mabula Nkuba, Tobias Hecker
Balancing ACT: evaluating the effectiveness of psychoeducation and Acceptance and Commitment Therapy (ACT) groups for people with bipolar disorder: study protocol for pilot randomised controlled trial
Emma O’Donoghue, Abigail Clark, Matthew Richardson, John Hodsoll, Sunil Nandha, Eric Morris, Fergus Kane, Deirdre O’Keeffe, Lucy Butler, Suzanne Jolley
The EKSPECT study: the influence of Expectation modification in Knee arthroplasty on Satisfaction of PatiEnts: study protocol for a randomized Controlled Trial
Jaap J. Tolk, Rob P. A. Janssen, Tsjitske M. Haanstra, Sita M. A. Bierma-Zeinstra, Max Reijman
The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis <12 months: protocol for a mixed-methods study including a randomized controlled trial
Anja Siegle, Matthias Villalobos, Jasmin Bossert, Katja Krug, Laura Hagelskamp, Johannes Krisam, Violet Handtke, Nicole Deis, Jana Jünger, Michel Wensing, Michael Thomas
The “Wholesome Contact” non-pharmacological, volunteer-delivered multidisciplinary programme to prevent hospital delirium in elderly patients: study protocol for a randomised controlled trial
Karolina Piotrowicz, Krzysztof Rewiuk, Stanisław Górski, Weronika Kałwak, Barbara Wizner, Agnieszka Pac, Michał Nowakowski, Tomasz Grodzicki
Heterogeneous perception of the ethical legitimacy of unbalanced randomization by institutional review board members: a clinical vignette-based survey
Clarisse Dibao-Dina, Agnès Caille, Bruno Giraudeau
Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial
Mads Gustaf Jørgensen, Navid Mohamadpour Toyserkani, Nana Hyldig, Annette Hougaard Chakera, Lisbet Rosenkrantz Hölmich, Jørn Bo Thomsen, Jens Ahm Sørensen
Partial factorial trials: comparing methods for statistical analysis and economic evaluation
Helen A. Dakin, Alastair M. Gray, Graeme S. MacLennan, Richard W. Morris, David W. Murray
Topiramate versus naltrexone for alcohol use disorder: study protocol for a genotype-stratified, double-blind randomised controlled trial (TOP study)
Kirsten C. Morley, Henry R. Kranzler, Natasha Luquin, Andrew Baillie, Marian Shanahan, Ronald Trent, Maree Teesson, Paul S. Haber
Metacognitive therapy home-based self-help for cardiac rehabilitation patients experiencing anxiety and depressive symptoms: study protocol for a feasibility randomised controlled trial (PATHWAY Home-MCT)
Adrian Wells, Kirsten McNicol, David Reeves, Peter Salmon, Linda Davies, Anthony Heagerty, Patrick Doherty, Rebecca McPhillips, Rebecca Anderson, Cintia Faija, Lora Capobianco, Helen Morley, Hannah Gaffney, Calvin Heal, Gemma Shields, Peter Fisher
Buying time: a proof-of-concept randomized controlled trial to improve sleep quality and cognitive function among older adults with mild cognitive impairment
Ryan S. Falck, Jennifer C. Davis, John R. Best, Linda C. Li, Patrick C. Y. Chan, Anne B. Wyrough, Glenn J. Landry, Teresa Liu-Ambrose
Effects of aerobic training on physical activity in people with stroke: protocol for a randomized controlled trial
Larissa Tavares Aguiar, Sylvie Nadeau, Raquel Rodrigues Britto, Luci Fuscaldi Teixeira-Salmela, Júlia Caetano Martins, Christina Danielli Coelho de Morais Faria
Anti-inflammatory treatment of depression: study protocol for a randomised controlled trial of vortioxetine augmented with celecoxib or placebo
Célia Fourrier, Emma Sampson, Natalie T. Mills, Bernhard T. Baune
Adherence to the International Committee of Medical Journal Editors’ (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals
Anand D. Gopal, Joshua D. Wallach, Jenerius A. Aminawung, Gregg Gonsalves, Rafael Dal-Ré, Jennifer E. Miller, Joseph S. Ross
Hit hard and early: analysing the effects of high-dose methylprednisolone on nailfold capillary changes and biomarkers in very early systemic sclerosis: study protocol for a 12-week randomised controlled trial
Wieneke M. T. van den Hombergh, Brigit E. Kersten, Hanneke K. A. Knaapen-Hans, Rogier M. Thurlings, Peter M. van der Kraan, Frank H. J. van den Hoogen, Jaap Fransen, Madelon C. Vonk
The impact of early-years provision in Children’s Centres (EPICC) on child cognitive and socio-emotional development: study protocol for a randomised controlled trial
Lynne Murray, Susie Jennings, Alicia Mortimer, Amber Prout, Edward Melhuish, Claire Hughes, John Duncan, Joni Holmes, Corinne Dishington, Peter J. Cooper
Core Outcome Set for GROwth restriction: deVeloping Endpoints (COSGROVE)
Patricia Healy, Sanne Gordijn, Wessel Ganzevoort, Irene Beune, Ahmet Baschat, Asma Khalil, Louise Kenny, Frank Bloomfield, Mandy Daly, Aris Papageorghiou, Declan Devane
Surgical vs. non-surgical management of displaced type-2 odontoid fractures in patients aged 75 years and older: study protocol for a randomised controlled trial
Anna-Lena Robinson, Gregor Schmeiser, Yohan Robinson, Claes Olerud
A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems
Jennifer A. Palmer, Vincent Mor, Angelo E. Volandes, Ellen McCreedy, Lacey Loomer, Phoebe Carter, Faye Dvorchak, Susan L. Mitchell
Effect of acupuncture for constipation after ischemic stroke: study protocol for a randomized controlled trial
Tao Zhang, Guiling Wang, Bin Li, Linpeng Wang, Jing Guo, Junxia Hu, Xin Du, Qiuyang Hong, Jingqing Sun, Cunzhi Liu
Gonadotropin-releasing hormone antagonist versus progestin for the prevention of premature luteinising hormone surges in poor responders undergoing in vitro fertilisation treatment: study protocol for a randomised controlled trial
Yun Wang, Yanping Kuang, Qiuju Chen, Renfei Cai
Evaluating the safety, tolerability, pharmacokinetics and efficacy of clofazimine in cryptosporidiosis (CRYPTOFAZ): study protocol for a randomized controlled trial
Patrick Nachipo, David Hermann, Gerald Quinnan, Melita A. Gordon, Wesley C. Van Voorhis, Pui-Ying Iroh Tam
Frailty Intervention Trial iN End-Stage patientS on haemodialysis (FITNESS): study protocol for a randomised controlled trial
Benjamin M. Anderson, Mary Dutton, Edward Day, Thomas A. Jackson, Charles J. Ferro, Adnan Sharif
Pharm-MD; an open-label, randomized controlled, phase II study to evaluate the efficacy of a pharmacist-managed diabetes clinic in high-risk diabetes patients – study protocol for a randomized controlled trial
Alexandra Halalau, Daniel Shelden, Scott Keeney, Jaspreet Hehar
Effects of massage as a recuperative technique on autonomic modulation of heart rate and cardiorespiratory parameters: a study protocol for a randomized clinical trial
Nilton Mantovani Junior, Eduardo Pizzo Junior, Malu dos Santos Siqueira, Allysiê Priscilla de Souza Cavina, Carlos Marcelo Pastre, Franciele Marques Vanderlei
Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: study protocol for a pilot randomized controlled trial, the PROTECTION trial
Tommaso Mauri, Giuseppe Foti, Carla Fornari, Jean-Michel Constantin, Claude Guerin, Paolo Pelosi, Marco Ranieri, Sara Conti, Daniela Tubiolo, Egle Rondelli, Federica Lovisari, Tommaso Fossali, Savino Spadaro, Domenico Luca Grieco, Paolo Navalesi, Italo Calamai, Tobias Becher, Oriol Roca, Yu-Mei Wang, Rihard Knafelj, Andrea Cortegiani, Jordi Mancebo, Laurent Brochard, Antonio Pesenti, Giacomo Grasselli, Elena Spinelli, Chiara Abbruzzese, Roberto Rona, Alfio Bronco, Silvia Villa, Stefano Gianni, Alessandra Papoff, Riccardo Pinciroli, Riccardo Colombo, Chiara Sproccati, Pietro Mandelli, Federico Villa, Nicolo’ Patroniti, Iole Brunetti, Lorenzo Ball, Carlo Alberto Volta, Marta Lazzeri, Elisabetta Maragoni, Davide Eleuteri, Giuseppe Bello, Antonio dell’Anna, Eugenio Garofalo, Andrea Bruni, Eugenio Biamonte, Rocco D’Andrea, Lorenzo Querci, Elisabetta Pierucci, Rosario Spina, Irene Mori, Francesco Tomeo, Alain Mercat, François Beloncle, Sebastien Jochmans, Sandie Mazerand, Loredana Baboi, Hodane Yonis, Matthieu Jabaudon, Thomas Godet, Tomas Jovaisa, Tom Barnes, Usman Tariq, Norbert Weiler, Dirk Schädler, Inéz Frerichs, Marina García-de-Acilu, Anxela Vidal, Emilia Rosas, César Pérez Calvo, Jian-Xin Zhou, Spiridon Karagiannis, Vasiliki Zisopoulou, Ioannis Staikos, Marko Noc, Misa Fister, Peter Radsel, Cesare Gregoretti, Ignazio Sabella, Santi Maurizio Raineri
Feasibility of a physical activity programme embedded into the daily lives of older adults living in nursing homes: protocol for a randomised controlled pilot feasibility study
Eva Barrett, Paddy Gillespie, John Newell, Dympna Casey
The effectiveness of different singly administered high doses of buprenorphine in reducing suicidal ideation in acutely depressed people with co-morbid opiate dependence: a randomized, double-blind, clinical trial
Jamshid Ahmadi, Mina Sefidfard Jahromi, Zahra Ehsaei
Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial
Yang Zhou, Yuming Peng, Jinghan Fang, Wanchen Sun, Guofu Zhang, Long Zhen, Gang Wang, Ruquan Han
Platelet-rich plasma in Achilles tendon healing 2 (PATH-2) trial: statistical analysis plan for a multicentre, double-blinded, parallel-group, placebo-controlled randomised clinical trial
Michael M. Schlüssel, David J. Keene, Susan Wagland, Joseph Alsousou, Sarah E. Lamb, Keith Willett, Susan J. Dutton, Keith Willett, Joseph Alsousou, Sarah E. Lamb, Paul Harrison, Philippa Hulley, Scott Parsons, Jacqueline Thompson, Chris Byrne, Lesley Morgan, Emma Roberts, Daryl Hagan, Ramona Barbu, Michael Schlüssel, Susan Dutton, Roger Smith, Catriona Graham, Dylan Morrissey, John O’Byrne, Gustaaf Reurink, Dishan Singh, Sarah Webb, Chao Huang, Andy Goldberg, Carey McClellan, Robert C. Handley, Maneesh Bhatia, Andrew Kelly, Steve Hepple, Michael Carmont, Paul Hodgson, Nima Heidari, Jonathan Young, Gareth Stables, Ravindran Ranjith, Simon Frostick, Jim Carmichael, Claire Topliss, Lyndon Mason, Moez Ballal, Nasser Kurdy, Mark Davies, Adrian Hughes, Simon Barnes, Matthew Solan
A small population, randomised, placebo-controlled trial to determine the efficacy of anakinra in the treatment of pustular psoriasis: study protocol for the APRICOT trial
Victoria Cornelius, Rosemary Wilson, Suzie Cro, Jonathan Barker, David Burden, Christopher E. M. Griffiths, Helen Lachmann, Helen McAteer, Nick Reynolds, Andrew Pink, Richard B. Warren, Francesca Capon, Catherine Smith
At-risk registers integrated into primary care to stop asthma crises in the UK (ARRISA-UK): study protocol for a pragmatic, cluster randomised trial with nested health economic and process evaluations
Jane R. Smith, Stanley Musgrave, Estelle Payerne, Michael Noble, Erika J. Sims, Allan B. Clark, Garry Barton, Hilary Pinnock, Aziz Sheikh, Andrew M. Wilson, Polly-Anna Ashford, Chris Butler, Ann-Louise Caress, Chris Griffiths, Lisa Irvine, Martin Pond, David Price, Ann Marie Swart, Susan Stirling, Mike Thomas, Samantha Walker
Zoledronic acid in the management of mesothelioma - a feasibility study (Zol-A Trial): study protocol for a randomised controlled trial
Duneesha de Fonseka, Anna Morley, Louise Stadon, Emma Keenan, Steven Walker, Sarah Smith, John E. Harvey, R. Ashley Cox, Adam Dangoor, Charles Comins, Christine Rogers, Anthony Edey, Alfredo Addeo, Nick A. Maskell
The inclusion of real world evidence in clinical development planning
Reynaldo Martina, David Jenkins, Sylwia Bujkiewicz, Pascale Dequen, Keith Abrams
Inverted internal limiting membrane insertion combined with air tamponade in the treatment of macular hole retinal detachment in high myopia: study protocol for a randomized controlled clinical trial
Ying Zheng, Mei Kang, Hong Wang, Haiyun Liu, Tao Sun, Xiaodong Sun, Fenghua Wang
Progressive early passive and active exercise therapy after surgical rotator cuff repair – study protocol for a randomized controlled trial (the CUT-N-MOVE trial)
Birgitte Hougs Kjær, S. Peter Magnusson, Susan Warming, Marius Henriksen, Michael Rindom Krogsgaard, Birgit Juul-Kristensen
The efficacy and safety of the herbal medicine geonchildan for patients with active rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled, parallel pilot trial
Seunghoon Lee, Yeeun Cho, Jihye Kim, Jung Won Kang, Ga Young Yoon, Jun-Hwan Lee, So-Young Jung, Ojin Kwon, Kyung-Min Shin, Jae-Dong Lee
(1,3)-β-D-glucan-based diagnosis of invasive Candida infection versus culture-based diagnosis in patients with sepsis and with an increased risk of invasive Candida infection (CandiSep): study protocol for a randomized controlled trial
Frank Bloos, Jürgen Held, Peter Schlattmann, Nicole Brillinger, Oliver Kurzai, Oliver A. Cornely, Daniel Thomas-Rüddel
The effect of remote ischemic preconditioning on serum creatinine in patients undergoing partial nephrectomy: a study protocol for a randomized controlled trial
Min Hur, Sun-Kyung Park, Jungho Shin, Jung-Yoon Choi, Seokha Yoo, Won Ho Kim, Jin-Tae Kim
Shenmai injection for the treatment of cancer-related fatigue in advanced non-small cell lung cancer patients undergoing chemotherapy: study protocol for a randomized controlled trial
Yushu Zhou, Baiming Zhao, Wanyin Wu, Xiaobing Yang, Shunqin Long, Hong Deng, Wenfeng He, Guiya Liao, Qiuping Li, Zhen Xie
Nerve root block versus surgery (NERVES) for the treatment of radicular pain secondary to a prolapsed intervertebral disc herniation: study protocol for a multi-centre randomised controlled trial
Martin J. Wilby, Carolyn Hopkins, Emma Bedson, Sue Howlin, Girvan Burnside, Elizabeth J. Conroy, Dyfrig A. Hughes, Manohar Sharma, Anthony Marson, Simon R. Clark, Paula Williamson
Arsenic trioxide and all-trans retinoic acid (ATRA) treatment for acute promyelocytic leukemia in all risk groups: study protocol for a randomized controlled trial
Xinxin Zhang, Huiyun Zhang, Limei Chen, Mengchang Wang, Jieying Xi, Xin Liu, Ming Xie, Dengzhe Li, Ekamjyot Singh Gulati, Sha Gong, Huaiyu Wang
The effects of combined exercise intervention based on Internet and social media software for postoperative patients with breast cancer: study protocol for a randomized controlled trial
Dong Xiaosheng, Yi Xiangren, Huang Shuyuan, Gao Dezong, Chao Mengyao, Ding Meng
Surgeons’ and methodologists’ perceptions of utilising an expertise-based randomised controlled trial design: a qualitative study
Jonathan A. Cook, Marion K. Campbell, Katie Gillies, Zoë Skea
Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study)
Anja Wittkowski, Kim Cartwright, Richard Emsley, Penny Bee, Elizabeth Camacho, Rachel Calam, Catherine Cross, Kathryn M. Abel, Holly Reid
Effect of a combined brief narrative exposure therapy with case management versus treatment as usual in primary care for patients with traumatic stress sequelae following intensive care medicine: study protocol for a multicenter randomized controlled trial (PICTURE)
Jochen Gensichen, Susanne Schultz, Christine Adrion, Konrad Schmidt, Maggie Schauer, Daniela Lindemann, Natalia Unruh, Robert P. Kosilek, Antonius Schneider, Martin Scherer, Antje Bergmann, Christoph Heintze, Stefanie Joos, Josef Briegel, Andre Scherag, Hans-Helmut König, Christian Brettschneider, Thomas G. Schulze, Ulrich Mansmann, Klaus Linde, Dagmar Lühmann, Karen Voigt, Sabine Gehrke-Beck, Roland Koch, Bernhard Zwissler, Gerhard Schneider, Herwig Gerlach, Stefan Kluge, Thea Koch, Andreas Walther, Oxana Atmann, Jan Oltrogge, Maik Sauer, Julia Schnurr, Thomas Elbert, Christine Adrion, Matthias Angstwurm, Oxana Atmann, Michael Bauer, Antje Bergmann, Laura Bertram, Gerhard Bielmeier, Ralph Bogdanski, Franz Brettner, Christian Brettschneider, Josef Briegel, Martin Bürkle, Ulrike Dorn, Thomas Elbert, Kristin Elbs, Peter Falkai, Richard Fisch, Hans Förstl, Benjamin Fohr, Martin Franz, Lorenz Frey, Patrick Friederich, Jürgen Gallinat, Sabine Gehrke-Beck, Jochen Gensichen, Herwig Gerlach, Andreas Güldner, Hanna Hardt, Christoph Heintze, Andreas Heinz, Axel Heller, Christian Heymann, Petra Hoppmann, Volker Huge, Michael Irlbeck, Ulrich Jaschinski, Dominik Jarczak, Stefanie Joos, Elisabeth Kaiser, Melanie Kerinn, Frank-Rainer Klefisch, Stefan Kluge, Tina Knäfel, Roland Koch, Thea Koch, Hans-Helmut König, Robert Kosilek, Martin Krüger, Peter Lackermeier, Karl-Ludwig Laugwitz, Yvonne Lemke, Achim Lies, Klaus Linde, Daniela Lindemann, Dagmar Lühmann, Ulrich Mansmann, Stephanie May, Thorsten Möller, Ludwig Ney, Jan Oltrogge, Wulf Pankow, Sergi Papiol, Maximilian Ragaller, Nikolaus Rank, Lorenz Reill, Ulf-Dietrich Reips, Reimer Riessen, Grit Ringeis, Maik Sauer, Maggie Schauer, Gustav Schelling, Jörg Schelling, André Scherag, Martin Scherer, Konrad Schmidt, Antonius Schneider, Gerhard Schneider, Jürgen Schneider, Ralph Schneider, Julia Schnurr, Susanne Schultz, Thomas G. Schulze, Karin Schumacher, Peter Spieth, Kerstin Theisen, Franka Thurm, Aline Ulbricht, Natalia Unruh, Thomas Vogl, Karen Voigt, Andreas Walther, Dietmar Wassilowsky, Steffen Weber-Carstens, Roland Weierstall, Marion Weis, Georg Weiss, Harald Well, Christian Zöllner, Bernhard Zwissler
Doing trials within trials: a qualitative study of stakeholder views on barriers and facilitators to the routine adoption of methodology research in clinical trials
Jo Rick, Mike Clarke, Alan A. Montgomery, Paul Brocklehurst, Rachel Evans, Peter Bower
The efficacy and safety of herbal medicine BHH10 in postmenopausal women with osteoporosis: study protocol for a phase II, multicenter, randomized, double-blinded, placebo-controlled clinical trial
Yeeun Cho, Seunghoon Lee, Jihye Kim, Jung Won Kang, Yong-Hyeon Baek, Byung-Kwan Seo, Jae-Dong Lee
Herbal medicine foot bath for the treatment of diabetic peripheral neuropathy: protocol for a randomized, double-blind and controlled trial
Guanjie Fan, Haoyue Huang, Yuping Lin, Guoqing Zheng, Xianyu Tang, Yu Fu, Hua Wei, Ling Zhao, Zhenjie Liu, Mei Wang, Shidong Wang, Qingbo Li, Zhaohui Fang, Yuehong Zhou, Fang Dai, Xiaotang Qiu
Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient–assessor blinded, controlled, parallel, clinical trial
Bonhyuk Goo, Dek-Woo Ryoo, Eun-Jung Kim, Dongwoo Nam, Hyun-Jong Lee, Jae-Soo Kim, Yeon-Cheol Park, Yong-Hyeon Baek, Byung-Kwan Seo
Efficacy of three-dimensionally integrated exercise for scoliosis in patients with adolescent idiopathic scoliosis: study protocol for a randomized controlled trial
Juping Liang, Xuan Zhou, Nan Chen, Xin Li, Hong Yu, Yuqi Yang, Yuanyuan Song, Qing Du
The effectiveness of a group-based computerized HIV/STI prevention intervention for black women who use drugs in the criminal justice system: study protocol for E-WORTH (Empowering African-American Women on the Road to Health), a Hybrid Type 1 randomized controlled trial
Karen Johnson, Louisa Gilbert, Timothy Hunt, Elwin Wu, Lisa Metsch, Dawn Goddard-Eckrich, Stanley Richards, Rick Tibbetts, Jessica C. Rowe, Milton L. Wainberg, Nabila El-Bassel
Effect of action-based cognitive remediation on cognition and neural activity in bipolar disorder: study protocol for a randomized controlled trial
Caroline V. Ott, Maj Vinberg, Christopher R. Bowie, Ellen Margrethe Christensen, Gitte M. Knudsen, Lars V. Kessing, Kamilla W. Miskowiak
Correction to: Palliative long-term abdominal drains versus repeated drainage in individuals with untreatable ascites due to advanced cirrhosis: study protocol for a feasibility randomised controlled trial
Lucia Macken, Louise Mason, Catherine Evans, Heather Gage, Jake Jordan, Mark Austin, Nick Parnell, Max Cooper, Shani Steer, Justine Boles, Stephen Bremner, Debbie Lambert, David Crook, Gemma Earl, Jean Timeyin, Sumita Verma
Clinical evaluation of modified transalveolar sinus floor elevation and osteotome sinus floor elevation in posterior maxillae: study protocol for a randomized controlled trial
Xu Zhao, Wei Gao, Feng Liu
Study protocol for single-center, open-label, randomized controlled trial to clarify the preventive efficacy of electrical stimulation for muscle atrophy after trauma
Makiko Yamamoto, Akio Kimura, Kento Takii, Naruaki Otake, Wataru Matsuda, Tatsuki Uemura, Takunori Sato, Kentaro Kobayashi, Ryo Sasaki, Akiyoshi Hagiwara, Junko Fujitani
Research on the mechanism of drug–drug interaction between salvianolate injection and aspirin based on the metabolic enzyme and PK-PD model: study protocol for a PK-PD trial
Wantong Zhang, Baochen Zhu, Weiyi Cao, Rui Li, Shuge Wang, Rui Gao
Acceptability to patients, carers and clinicians of an mHealth platform for the management of Parkinson’s disease (PD_Manager): study protocol for a pilot randomised controlled trial
Angelo Antonini, Giovanni Gentile, Manuela Giglio, Andrea Marcante, Heather Gage, Morro M. L. Touray, Dimitrios I. Fotiadis, Dimitris Gatsios, Spyridon Konitsiotis, Lada Timotijevic, Bernadette Egan, Charo Hodgkins, Roberta Biundo, Clelia Pellicano, Harry Hatzakis, Joao Correia, Angelo Antonini, Andrea Marcante, Roberta Biundo, Giovanni Gentile, Giglio Manuela, Luca Weis, Margherita Chiarot, Viviana Zanin, Barbara Korousic Seljak, Bojan Cestnik, Darko Aleksovski, Dragana Miljkovic, Franc Novak, Marko Bohanec, Tina Anzic, Vid Podpecan, Anita Valmarska, Gregor Papa, Bojan Blazica, Biljana Mileva Boshkoska, Robert Vilzmann, Francesca Assogna, Gianfranco Spalletta, Clelia Pellicano, Gaia Romana Pellicano, Valentina Palma, Cristina Scudellari, Tiziana Soru, Mino Napoletano, Francesca Fanciulli, Matteo Raffaelli, Adrian Banks, Brian Elliot, Charo Hodgkins, Ellen Seiss, Heather Gage, Lada Timotijevic, Bernadette Egan, Patrice Rusconi, Matthew Peacock, Sarah Gillies, Elizabeth Puttock, Morro M. L. Touray, Dimitris Gatsios, Dimitris Gatsios, George Rigas, Dimitrios Fotiadis, Cecilia Vera, Javier Uceda, Samanta Villanueva Mascato, Javier Rojo de la Cal, José Javier Serrano Olmedo, Fernando Martinez, Maria Teresa Arrendondo, Imre Cikajlo, Karmen Peterlin-Potisk
Electroacupuncture to treat with Overactive Bladder in Postmenopausal Women: study protocol for a multicenter, randomized, controlled, parallel clinical trial
Eun-Young Nam, Ju-Yeon Park, Junyoung Jo, Seung-Hyun Jung, Chi-Yeon Lim, Dong-Il Kim
Facilitators and challenges in recruiting pregnant women to an infant obesity prevention programme delivered via telephone calls or text messages
Mahalakshmi Ekambareshwar, Seema Mihrshahi, Li Ming Wen, Sarah Taki, Greer Bennett, Louise A. Baur, Chris Rissel
Total thyroidectomy (Tx) versus thionamides (antithyroid drugs) in patients with moderate-to-severe Graves’ ophthalmopathy – a 1-year follow-up: study protocol for a randomized controlled trial
Lindsay Brammen, Philipp Riss, Julius Lukas, Alois Gessl, Daniela Dunkler, Shuren Li, Asha Leisser, Sandra Rezar-Dreindl, Katharina Eibenberger, Andreas Selberherr, Christian Scheuba, Andrea Papp
Reducing disability via a family centered intervention for acutely ill persons with Alzheimer’s disease and related dementias: protocol of a cluster-randomized controlled trial (Fam-FFC study)
Marie Boltz, Ashley Kuzmik, Barbara Resnick, Rebecca Trotta, Jacqueline Mogle, Rhonda BeLue, Douglas Leslie, James E. Galvin
Caveat emptor: the combined effects of multiplicity and selective reporting
Tianjing Li, Evan Mayo-Wilson, Nicole Fusco, Hwanhee Hong, Kay Dickersin
Superiority and non-inferiority: two sides of the same coin?
David T. Dunn, Andrew J. Copas, Peter Brocklehurst
Evaluating the integration of HIV self-testing into low-resource health systems: study protocol for a cluster-randomized control trial from EQUIP Innovations
Kathryn Dovel, Frackson Shaba, Mike Nyirenda, O. Agatha Offorjebe, Kelvin Balakasi, Khumbo Phiri, Brooke Nichols, Chi-Hong Tseng, Ashley Bardon, Khumbo Ngona, Risa Hoffman
Apatinib for patients with advanced or recurrent cervical cancer: study protocol for an open-label randomized controlled trial
Jian-Guo Zhou, Nan-Jing Zhou, Qiong Zhang, Yao-yao Feng, Hang Zhou
Optimising pain management in children with acute otitis media through a primary care-based multifaceted educational intervention: study protocol for a cluster randomised controlled trial
Rick T. van Uum, Roderick P. Venekamp, Alies Sjoukes, Alma C. van de Pol, G. Ardine de Wit, Anne G. M. Schilder, Roger A. M. J. Damoiseaux
An Internet-based Acceptance and Commitment Therapy intervention for older adults with anxiety complaints: study protocol for a cluster randomized controlled trial
Maartje Witlox, Vivivan Kraaij, Nadia Garnefski, Margot W. M. de Waal, Filip Smit, Erik Hoencamp, Jacobijn Gussekloo, Ernst T. Bohlmeijer, Philip Spinhoven
The effect of optimised patient information materials on recruitment in a lung cancer screening trial: an embedded randomised recruitment trial
Adwoa Parker, Peter Knapp, Shaun Treweek, Vichithranie Madhurasinghe, Roberta Littleford, Stephanie Gallant, Frank Sullivan, Stuart Schembri, Jo Rick, Jonathan Graffy, David J. Collier, Sandra Eldridge, Anne Kennedy, Peter Bower
Surveying knowledge, practice and attitudes towards intervention fidelity within trials of complex healthcare interventions
Daragh McGee, Fabiana Lorencatto, Karen Matvienko-Sikar, Elaine Toomey
The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs
Aviv Ladanie, Benjamin Speich, Florian Naudet, Arnav Agarwal, Tiago V. Pereira, Francesco Sclafani, Juan Martin-Liberal, Thomas Schmid, Hannah Ewald, John P. A. Ioannidis, Heiner C. Bucher, Benjamin Kasenda, Lars G. Hemkens
A comparison of emotion-focused therapy and cognitive-behavioural therapy in the treatment of generalised anxiety disorder: study protocol for a randomised controlled trial
Ladislav Timulak, Daragh Keogh, Craig Chigwedere, Charlotte Wilson, Fiona Ward, David Hevey, Patrick Griffin, Louise Jacobs, Brenda Irwin
A protocol update for the Selenium Treatment and Chagasic Cardiomyopathy (STCC) trial
Marcelo Teixeira Holanda, Mauro Felippe Felix Mediano, Alejandro Marcel Hasslocher-Moreno, Sérgio Salles Xavier, Roberto Magalhães Saraiva, Andrea Silvestre Sousa, Erica Rodrigues Maciel, Fernanda Martins Carneiro, Paula Simplicio da Silva, Luiz Henrique Conde Sangenis, Henrique Horta Veloso, Claudia Santos de Aguiar Cardoso, Maria da Gloria Bonecini-Almeida, Andreia Lamoglia Souza, Eric Henrique Roma, Marcos José Azevedo, Fernanda Sant’Ana Pereira-Silva, Luis Otavio Pimentel, Marcelo Oliveira Mendes, Luciana Ribeiro Garzoni, Beatriz M. S. Gonzaga, Anna Cristina Calçada Carvalho, Pedro Emmanuel Alvarenga Americano Brasil, Gilberto Marcelo Sperandio da Silva, Tania Cremonini Araújo-Jorge
A randomized pragmatic care trial on endovascular acute stroke interventions (EASI): criticisms, responses, and ethics of integrating research and clinical care
Robert Fahed, Stefanos Finitsis, Naim Khoury, Yan Deschaintre, Nicole Daneault, Laura Gioia, Gregory Jacquin, Céline Odier, Alexande Y. Poppe, Alain Weill, Daniel Roy, Tim E. Darsaut, Thanh N. Nguyen, Jean Raymond
An audit to evaluate an institute’s lead researchers’ knowledge of trial registries and to investigate adherence to data transparency issues in an Italian research institute registry
Chiara Pandolfini, Maurizio Bonati
Real-time feedback, debriefing, and retraining system of cardiopulmonary resuscitation for out-of-hospital cardiac arrests: a study protocol for a cluster parallel-group randomized controlled trial
Akihiro Hirakawa, Toshihiro Hatakeyama, Daisuke Kobayashi, Chika Nishiyama, Akiko Kada, Takeyuki Kiguchi, Takashi Kawamura, Taku Iwami
Targeted gluteal exercise versus sham exercise on self-reported physical function for people with hip osteoarthritis (the GHOst trial – Gluteal exercise for Hip Osteoarthritis): a protocol for a randomised clinical trial
Adam Ivan Semciw, Tania Pizzari, Stephanie Woodley, Anita Zacharias, Michael Kingsley, Rod A. Green
Tai chi for overweight/obese adolescent and young women with polycystic ovary syndrome: study protocol for a randomized controlled trial
Yan Li, Changle Peng, Guangying Cao, Wei Li, Lihui Hou
Effect of persuasive messages on National Health Service Organ Donor Registrations: a pragmatic quasi-randomised controlled trial with one million UK road taxpayers
Anna Sallis, Hugo Harper, Michael Sanders
Paediatric Autism Communication Therapy-Generalised (PACT-G) against treatment as usual for reducing symptom severity in young children with autism spectrum disorder: study protocol for a randomised controlled trial
Jonathan Green, Catherine Aldred, Tony Charman, Ann Le Couteur, Richard A. Emsley, Victoria Grahame, Patricia Howlin, Neil Humphrey, Kathy Leadbitter, Helen McConachie, Jeremy R. Parr, Andrew Pickles, Vicky Slonims, Carol Taylor, Matea Balabanovska, Hilary Beach, Claire Bennett, Sophie Carruthers, Imogen Crook, Hannah Danvers, Kate Dartnall, Ceri Ellis, Hannah Foote, Jessica Graham, Kirsty James, Sarah Jamieson, Anna Knight, Jo Lowe, Ruth Madeley, Olivia Mitchell, Francisca Monteiro, Heather L. Moore, Helen Morley, Jessica Rose, Lauren Taylor, Su Vosper
Xue-Fu-Zhu-Yu capsule in the treatment of qi stagnation and blood stasis syndrome: a study protocol for a randomised controlled pilot and feasibility trial
Haoqiang He, Guang Chen, Jialiang Gao, Yu Liu, Chenhao Zhang, Chao Liu, Hongzheng Li, Qingyong He, Jun Li, Jie Wang
Correction to: Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study)
Anja Wittkowski, Kim Cartwright, Richard Emsley, Penny Bee, Elizabeth Camacho, Rachel Calam, Catherine Cross, Kathryn M. Abel, Holly Reid
A double blind randomised control trial investigating the efficacy of platelet rich plasma versus placebo for the treatment of greater trochanteric pain syndrome (the HIPPO trial): a protocol for a randomised clinical trial
Eshan Oderuth, Mohammed Ali, Ismael Atchia, Ajay Malviya
A novel taping therapy for pain after arthroscopic shoulder surgery: study protocol for a randomised controlled pilot trial
Sun-Young Moon, Jung-Eun Kim, O-Jin Kwon, Ae-Ran Kim, Da-Heui Kim, Jae-Hong Kim, Hwa Soo Hwang, Changsop Yang
Culturally tailored, peer-based sleep health education and social support to increase obstructive sleep apnea assessment and treatment adherence among a community sample of blacks: study protocol for a randomized controlled trial
Azizi A. Seixas, Chau Trinh-Shevrin, Joseph Ravenell, Gbenga Ogedegbe, Ferdinand Zizi, Girardin Jean-Louis
The cost-effectiveness and cost-utility of at-home infrared temperature monitoring in reducing the incidence of foot ulcer recurrence in patients with diabetes (DIATEMP): study protocol for a randomized controlled trial
Wouter B. aan de Stegge, Nora Mejaiti, Jaap J. van Netten, Marcel G. W. Dijkgraaf, Jeff G. van Baal, Tessa E. Busch-Westbroek, Sicco A. Bus
PATCH: posture and mobility training for care staff versus usual care in care homes: study protocol for a randomised controlled trial
Liz Graham, Robert Cicero, David Clarke, Bonnie Cundill, Alison Ellwood, Amanda Farrin, Jill Fisher, Madeline Goodwin, Rebecca Hawkins, Karen Hull, Claire Hulme, Dominic Trépel, Rachel Williams, Anne Forster
Study protocol for a randomised, double-blind, placebo-controlled 12-week pilot phase II trial of Sailuotong (SLT) for cognitive function in older adults with mild cognitive impairment
Genevieve Z. Steiner, Alan Bensoussan, Jianxun Liu, Mark I. Hohenberg, Dennis H. Chang
Silver diamine fluoride versus therapeutic sealants for the arrest and prevention of dental caries in low-income minority children: study protocol for a cluster randomized controlled trial
Ryan Richard Ruff, Richard Niederman
Antenatal sildenafil administration to prevent pulmonary hypertension in congenital diaphragmatic hernia (SToP-PH): study protocol for a phase I/IIb placenta transfer and safety study
Francesca Maria Russo, Alexandra Benachi, Tim Van Mieghem, Jan De Hoon, Kristel Van Calsteren, Pieter Annaert, Jean-Marc Tréluyer, Karel Allegaert, Jan Deprest
Developing a framework for the ethical design and conduct of pragmatic trials in healthcare: a mixed methods research protocol
Monica Taljaard, Charles Weijer, Jeremy M. Grimshaw, Adnan Ali, Jamie C. Brehaut, Marion K. Campbell, Kelly Carroll, Sarah Edwards, Sandra Eldridge, Christopher B. Forrest, Bruno Giraudeau, Cory E. Goldstein, Ian D. Graham, Karla Hemming, Spencer Phillips Hey, Austin R. Horn, Vipul Jairath, Terry P. Klassen, Alex John London, Susan Marlin, John C. Marshall, Lauralyn McIntyre, Joanne E. McKenzie, Stuart G. Nicholls, P. Alison Paprica, Merrick Zwarenstein, Dean A. Fergusson
The evaluation of changes in peripheral neuropathy and quality-of-life using low-frequency electrostimulation in patients treated with chemotherapy for breast cancer: a study protocol
Chang eun Jang, Mi Sook Jung, Eun Hee Sohn, Mijung Kim, Hwa-Seung Yoo, Kyeore Bae, Je Ryong Kim, Jin Sun Lee
A fixed nitrous oxide/oxygen mixture as an analgesic for trauma patients in emergency department: study protocol for a randomized, controlled trial
Lu-Lu Gao, Li-Shan Yang, Jun-Jun Zhang, Yi-Ling Wang, Ke Feng, Lei Ma, Yuan-Yuan Yu, Qiang Li, Qing-Huan Wang, Jin-Tao Bao, Ya-Liang Dai, Qiang Liu, Yu-Xiang Li, Qiang-Jian Yu
Patients’ reasoning regarding the decision to participate in clinical cancer trials: an interview study
Pia Dellson, Kerstin Nilsson, Helena Jernström, Christina Carlsson
Acupuncture for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial
Li-xia Pei, Hao Geng, Hao Chen, Xiao-liang Wu, Lu Chen, Jun-ling Zhou, Lu Ju, Gao Lu, Wan-li Xu, Shan Qin, Jing Guo, Eun Mee Yang, Jian-hua Sun
The feasibility of following up prisoners, with mental health problems, after release: a pilot trial employing an innovative system, for engagement and retention in research, with a harder-to-engage population
Cath Quinn, Richard Byng, Deborah Shenton, Cordet Smart, Susan Michie, Amy Stewart, Rod Taylor, Mike Maguire, Tirril Harris, Jenny Shaw
Reduced fetal movement intervention Trial-2 (ReMIT-2): protocol for a pilot randomised controlled trial of standard care informed by the result of a placental growth factor (PlGF) blood test versus standard care alone in women presenting with reduced fetal movement at or after 36+ 0 weeks gestation
Lindsay Armstrong-Buisseret, Eleanor Mitchell, Trish Hepburn, Lelia Duley, Jim G. Thornton, Tracy E. Roberts, Claire Storey, Rebecca Smyth, Alexander E. P. Heazell
A web-based education program to encourage organ donation registration among lower-educated adolescents in the Netherlands: study protocol for a cluster randomized controlled trial
Esther Steenaart, Rik Crutzen, Math J J M Candel, Nanne K de Vries
Outcome measures in clinical trials of treatments for acute severe haemorrhage
Amy Brenner, Monica Arribas, Jack Cuzick, Vipul Jairath, Simon Stanworth, Katharine Ker, Haleema Shakur-Still, Ian Roberts
Treatment of pustular psoriasis with anakinra: a statistical analysis plan for stage 1 of an adaptive two-staged randomised placebo-controlled trial
Suzie Cro, Catherine Smith, Rosemary Wilson, Victoria Cornelius
Recruiting care homes to a randomised controlled trial
Alison Ellwood, Jennifer Airlie, Robert Cicero, Bonnie Cundill, David R Ellard, Amanda Farrin, Mary Godfrey, Liz Graham, John Green, Vicki McLellan, Najma Siddiqi, Anne Forster, Karen Birch, David Ellard, Amanda Farrin, Joan Firth, Anne Forster, Bev Gallagher, Mary Godfrey, Elizabeth Graham, Claire Hulme, Rebecca Lawton, Najma Siddiqi, John Young
Optimizing huddle engagement through leadership and problem-solving within primary care: A study protocol for a cluster randomized trial
Megan E. Branda, Aravind Chandrasekaran, Marc D. Tumerman, Nilay D. Shah, Peter Ward, Bradley R. Staats, Theresa M. Lewis, Diane K. Olson, Rachel Giblon, Michelle A. Lampman, David R. Rushlow
Physical Activity after Cardiac EventS (PACES) – a group education programme with subsequent text-message support designed to increase physical activity in individuals with diagnosed coronary heart disease: study protocol for a randomised controlled trial
Louisa Y Herring, Helen Dallosso, Sudesna Chatterjee, Danielle Bodicoat, Sally Schreder, Kamlesh Khunti, Tom Yates, Sam Seidu, Ian Hudson, Melanie J Davies
The effects of dietary instruction on cardiovascular risk markers after smoking cessation: study protocol for a multicenter randomized controlled trial in Japan
Maki Komiyama, Yuka Ozaki, Hiromichi Wada, Hajime Yamakage, Noriko Satoh-Asahara, Tatsuya Morimoto, Akira Shimatsu, Yuko Takahashi, Koji Hasegawa
Clinical significance in pediatric oncology randomized controlled treatment trials: a systematic review
A. Fuchsia Howard, Karen Goddard, Shahrad Rod Rassekh, Osama A Samargandi, Haroon Hasan
Behavioral economics-based incentives supported by mobile technology on HIV knowledge and testing frequency among Latino/a men who have sex with men and transgender women: Protocol for a randomized pilot study to test intervention feasibility and acceptability
Sebastian Linnemayr, Sarah MacCarthy, Alice Kim, Rebecca Giguere, Alex Carballo-Dieguez, Joanna L. Barreras
Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol
Ruijin Qiu, Min Li, Xiaoyu Zhang, Shiqi Chen, Chengyu Li, Hongcai Shang
Choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial – the development of the DELTA2 guidance
William Sones, Steven A. Julious, Joanne C. Rothwell, Craig Robert Ramsay, Lisa V. Hampson, Richard Emsley, Stephen J. Walters, Catherine Hewitt, Martin Bland, Dean A. Fergusson, Jesse A. Berlin, Doug Altman, Luke David Vale, Jonathan Alistair Cook
The LEAD trial - the effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: study protocol for a randomized controlled trial
Pernille Gabel, Mette Bach Larsen, Pia Kirkegaard, Adrian Edwards, Berit Andersen
A study of target effect sizes in randomised controlled trials published in the Health Technology Assessment journal
Joanne C. Rothwell, Steven A. Julious, Cindy L. Cooper
Aerobic exercise program with or without motor complexity as an add-on to the pharmacological treatment of depression – study protocol for a randomized controlled trial
Lucas Melo Neves, Carla Silva-Batista, Raquel Marquesini, Telma Fátima da Cunha, Elisa Dimateo, Luciana Nascimento, Acácio Moreira-Neto, Angelo Corrêa de Lima Miliatto, Sheila das Chagas Mendes, Flavia Saad, Jamile Sanches Codogno, Renato Hoffmann Nunes, Raphael Mendes Ritti-Dias, Valeria Juday, Beny Lafer, Carlos Ugrinowitsch
Cognitive aids for people with early stage dementia versus treatment as usual (Dementia Early Stage Cognitive Aids New Trial (DESCANT)): study protocol for a randomised controlled trial
Helen Chester, Paul Clarkson, Linda Davies, Jane Hughes, Muhammad Saiful Islam, Narinder Kapur, Martin Orrell, Julie Peconi, Rosa Pitts, Fiona Poland, Ian Russell, David Challis
Psychological Support for Personality (PSP) versus treatment as usual: study protocol for a feasibility randomized controlled trial of a low intensity intervention for people with personality disorder
Mike J Crawford, Lavanya Thana, Jennie Parker, Oliver Turner, Kwek Pei Xing, Mary McMurran, Paul Moran, Timothy Weaver, Barbara Barrett, Amy Claringbold, Paul Bassett, Rahil Sanatinia
Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation
S Rosen, M Maskew, A T Brennan, M P Fox, L Vezi, P D Ehrenkranz, W D F Venter
Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial
Hui-Yun Zhu, Pei Xie, Ying-Xiao Song, Zhao-Shen Li, Zhen-Dong Jin, Yi-Qi Du
A community-based intervention (Young SMILES) to improve the health-related quality of life of children and young people of parents with serious mental illness: randomised feasibility protocol
Judith Gellatly, Penny Bee, Lina Gega, Peter Bower, Diane Hunter, Paul Stewart, Nicky Stanley, Rachel Calam, Kim Holt, Miranda Wolpert, Simon Douglas, Jonathan Green, Adekeye Kolade, Craig Callender, Kathryn M Abel
Effect of training community health workers and their interventions on cardiovascular disease risk factors among adults in Morogoro, Tanzania: study protocol for a cluster randomized controlled trial
Alfa J Muhihi, David P Urassa, Rose N M Mpembeni, Germana H Leyna, Bruno F Sunguya, Deodatus Kakoko, Anna Tengia Kessy, Marina A Njelekela
“Yellow-dragon Wonderful-seed Formula” for hyperuricemia in gout patients with dampness-heat pouring downward pattern: a pilot randomized controlled trial
Xiao Ning Yu, Hai Yan Wu, Yuan Ping Deng, Guang Tong Zhuang, Bang Huan Tan, Yan Zhou Huang, Shi Yun Tang, Xiang Tu, James B Jordan, Sen Zhong
Prevention of striae gravidarum: study protocol for a pilot randomised controlled trial
Miriam Brennan, Mike Clarke, John Newell, Declan Devane
Conservative therapy for the treatment of patients with somatic tinnitus attributed to temporomandibular dysfunction: study protocol of a randomised controlled trial
Sarah Michiels, Annemarie Christien van der Wal, Evelien Nieste, Paul Van de Heyning, Marc Braem, Corine Visscher, Vedat Topsakal, Annick Gilles, Laure Jacquemin, Marianne Hesters, Willem De Hertogh
Prevention of post-concussion-like symptoms in patients presenting at the emergency room, early single eye movement desensitization, and reprocessing intervention versus usual care: study protocol for a two-center randomized controlled trial
Cédric Gil-Jardiné, Samantha Al Joboory, Juliane Tortes Saint Jammes, Guillaume Durand, Régis Ribéreau-Gayon, Michel Galinski, Louis-Rachid Salmi, Philippe Revel, Cyril Alexandre Régis, Guillaume Valdenaire, Emmanuel Poulet, Karim Tazarourte, Emmanuel Lagarde
Correction to: Evaluating the impact of Marie Stopes International’s digital family planning counselling application on the uptake of long-acting and permanent methods of contraception in Vietnam and Ethiopia: a study protocol for a multi-country cluster randomised controlled trial
Laura A. Bates, Joseph P. Hicks, John Walley, Emily Robinson
Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a Delphi study
Diane Whitham, Julie Turzanski, Lucy Bradshaw, Mike Clarke, Lucy Culliford, Lelia Duley, Lisa Shaw, Zoe Skea, Shaun P. Treweek, Kate Walker, Paula R. Williamson, Alan A. Montgomery, Simon Bevan, Lucy Bradshaw, Mike Clarke, Lucy Culliford, Adam Devall, Lelia Duley, Kathryn Fairbrother, Kirsteen Goodman, Catherine Hewitt, Rachel Hobson, Sarah Lawton, Stephen Lock, Alison McDonald, Alan Montgomery, John Norrie, Alastair O’Brien, Sarah Pearson, Shelley Rhodes, Lisa Shaw, Zoe Skea, Claire Snowdon, Kim Thomas, Shaun Treweek, Julie Turzanski, Kate Walker, Diane Whitham, Paula Williamson, Jill Wood
Cluster-randomized trial of monthly malaria prophylaxis versus focused screening and treatment: a study protocol to define malaria elimination strategies in Cambodia
Jessica Manning, Chanthap Lon, Michele Spring, Mariusz Wojnarski, Sok Somethy, Soklyda Chann, Panita Gosi, Kin Soveasna, Sabaithip Sriwichai, Worachet Kuntawunginn, Mark M Fukuda, Philip L Smith, Huy Rekol, Muth Sinoun, Mary So, Jessica Lin, Prom Satharath, David Saunders
Effect of electroacupuncture at homotopic and heterotopic acupoints on abdominal pain in patients with irritable bowel syndrome: study protocol for a randomized controlled trial
Yanhui Peng, Hui You, Xiaoman Chen, Yanbing Chen, Yiling Yang, Jianpeng Huang, Nenggui Xu, Jianhua Liu
The clinical and cost effectiveness of adapted dialectical behaviour therapy (DBT) for bipolar mood instability in primary care (ThrIVe-B programme): a feasibility study
Kim Wright, Alyson Dodd, Fiona C Warren, Antonieta Medina-Lara, Rod Taylor, Steven Jones, Christabel Owens, Mahmood Javaid, Barney Dunn, Julie E Harvey, Alexandra Newbold, Tom Lynch
Protocol and methods for testing the efficacy of well-being therapy in chronic migraine patients: a randomized controlled trial
Giovanni Mansueto, Francesco De Cesaris, Pierangelo Geppetti, Fiammetta Cosci
Monitoring performance of sites within multicentre randomised trials: a systematic review of performance metrics
Kate F. Walker, Julie Turzanski, Diane Whitham, Alan Montgomery, Lelia Duley
Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol
Peter Nymberg, Eva Ekvall Hansson, Emelie Stenman, Susanna Calling, Kristina Sundquist, Jan Sundquist, Bengt Zöller
Expert versus generalist inserters for peripheral intravenous catheter insertion: a pilot randomised controlled trial
Nicole Marsh, Joan Webster, Emily Larsen, Jodie Genzel, Marie Cooke, Gabor Mihala, Sue Cadigan, Claire M Rickard
ConFIRM trial - conversion of in vitro fertilization cycles to intrauterine inseminations in patients with a poor ovarian response to stimulation: a protocol for a multicentric, prospective randomized trial
Léa Delbos, Elsa Parot-Schinkel, Hady El Hachem, Guillaume Legendre, Philippe Descamps, Lisa Boucret, Véronique Ferré-L’Hotellier, Pauline Jeanneteau, Cécile Dreux, Catherine Morinière, Pascale May-Panloup, Pierre-Emmanuel Bouet
Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults – SYGRAVA: study protocol for a randomized trial
Romy Scholz, Johannes Lemcke, Ullrich Meier, Dirk Stengel
The therapeutic potential of attentional bias modification training for insomnia: study protocol for a randomised controlled trial
Umair Akram, Bronwyn Milkins, Antonia Ypsilanti, John Reidy, Lambros Lazuras, Jodie Stevenson, Lies Notebaert, Nicola L. Barclay
Adolescent depression: Study protocol for a randomized, controlled, double-blind multicenter parallel group trial of Bright Light Therapy in a naturalistic inpatient setting (DeLight)
Martin Holtmann, Laura Mokros, Inken Kirschbaum-Lesch, Michael Kölch, Paul L. Plener, Christian Ruckes, Michael Schulte-Markwort, Tanja Legenbauer
A protocol for the process evaluation of a multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission
Petra Mäkelä, Mary Godfrey, Andrea Cradduck-Bamford, Graham Ellis, Sasha Shepperd
Correction to: Prevention of seroma following inguinal lymph node dissection with prophylactic, incisional, negative-pressure wound therapy (SEROMA trial): study protocol for a randomized controlled trial
Mads Gustaf Jørgensen, Navid Mohamadpour Toyserkani, Nana Hyldig, Annette Hougaard Chakera, Lisbet Rosenkrantz Hölmich, Jørn Bo Thomsen, Jens Ahm Sørensen
Effectiveness-implementation of COPD case finding and self-management action plans in low- and middle-income countries: global excellence in COPD outcomes (GECo) study protocol
Trishul Siddharthan, Suzanne L Pollard, Shumonta A Quaderi, Andrew J Mirelman, Maria Kathia Cárdenas, Bruce Kirenga, Natalie A Rykiel, J Jaime Miranda, Laxman Shrestha, Ram K Chandyo, Adithya Cattamanchi, Susan Michie, Julie Barber, William Checkley, John R Hurst, Shumonta Quaderi, Susan Michie, John R Hurst, Zachos Anastasiou, Julie Barber, Trishul Siddharthan, Suzanne L Pollard, Brooks Morgan, Natalie A Rykiel, Mathew Grigsby, Nicole Robertson, Robert A Wise, William Checkley, Laxman Shrestha, Karbir Nath Yogi, Arun Sharma, Ram K Chandyo, Patricia Alupo, Denis Muwonge, Denis Mawanda, Faith Nassali, Robert Kalyesubula, Bruce Kirenga, Andrew J Mirelman, Marta Soares, Oscar Flores-Flores, Elisa Romani-Huacani, Maria Kathia Cárdenas, J Jaime Miranda, Adithya Cattamanchi
Considerations for adaptive design in pediatric clinical trials: study protocol for a systematic review, mixed-methods study, and integrated knowledge translation plan
Lauren E Kelly, Michele P Dyson, Nancy J Butcher, Robert Balshaw, Alex John London, Christine J Neilson, Anne Junker, Salaheddin M Mahmud, S Michelle Driedger, Xikui Wang
Physical exercise and cognitive engagement outcomes for mild neurocognitive disorder: a group-randomized pilot trial
Liselotte De Wit, Deirdre O’Shea, Melanie Chandler, Tripti Bhaskar, Jared Tanner, Prashanthi Vemuri, Julia Crook, Miranda Morris, Glenn Smith
Video clinics versus standard face-to-face appointments for liver transplant patients in routine hospital outpatient care: study protocol for a pragmatic randomised evaluation of myVideoClinic
Elaine O’Connell Francischetto, Sarah Damery, James Ferguson, Gill Combes, Gill Combes, Sarah Damery, Eric Deeson, James Ferguson, Janet Jones, Foyzal Miah, Pamela Nayyar, Elaine O’Connell Francischetto, Aziz Sheikh, Katie Squire
Dexamethasone therapy versus surgery for chronic subdural haematoma (DECSA trial): study protocol for a randomised controlled trial
Ishita P. Miah, Dana C. Holl, Wilco C. Peul, Robert Walchenbach, Nyika Kruyt, Karlijn de Laat, Radboud W. Koot, Victor Volovici, Clemens M. F. Dirven, Fop van Kooten, Kuan H. Kho, Heleen M. den Hertog, Joukje van der Naalt, Bram Jacobs, Rob J. M. Groen, Hester F. Lingsma, Ruben Dammers, Korné Jellema, Niels A. van der Gaag
Movement through Active Personalised engagement (MAP) — a self-management programme designed to promote physical activity in people with multimorbidity: study protocol for a randomised controlled trial
Helen Dallosso, Tom Yates, Hamidreza Mani, Laura J. Gray, Nafeesa Dhalwani, Emma Baldry, Clare Gillies, Sue Cradock, Mark Batt, Melanie J. Davies, Kamlesh Khunti
Guanxinjing capsule in the treatment of chronic stable angina: study protocol for a randomized controlled trial
Ying Tian, Junhua Zhang, Yingqiang Zhao, Jingyuan Mao, Linping Zhu, Rui Gao, Xuemei Wang, Mingjun Zhu, Lihong Ma, Mengyu Zhao, Wenke Zheng
Multicentre, double-blind, crossover trial to identify the Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus (OPTION-DM): study protocol for a randomised controlled trial
Dinesh Selvarajah, Jennifer Petrie, David White, Steven Julious, Oscar Bortolami, Cindy Cooper, Mike Bradburn, Amanda Loban, Helen Bowler, Lizzie Swaby, Katie Sutherland, Solomon Tesfaye, Satyan Rajbhandari, David Bennett, Rajiv Gandhi, Edward Jude, Gerry Rayman, Prashanth Vas, Ravikanth Gouni, Didier Bouhassira, Michelle Horspool, Martin Johnson, Tracey Young
Community-based intervention for management of diabetes in Nepal (COBIN-D trial): study protocol for a cluster-randomized controlled trial
Bishal Gyawali, Dinesh Neupane, Abhinav Vaidya, Annelli Sandbæk, Per Kallestrup
Correction to: Intrauterine resuscitation during the second stage of term labour by maternal hyperoxygenation versus conventional care: study protocol for a randomised controlled trial (INTEREST O2)
Lauren M. Bullens, Alexandra D. J. Hulsenboom, Suzanne Moors, Rohan Joshi, Pieter J. van Runnard Heimel, M. Beatrijs van der Hout-van der Jagt, Edwin R. van den Heuvel, S. Guid Oei
Registration, results reporting, and publication bias of clinical trials supporting FDA approval of neuropsychiatric drugs before and after FDAAA: a retrospective cohort study
Constance X. Zou, Jessica E. Becker, Adam T. Phillips, James M. Garritano, Harlan M. Krumholz, Jennifer E. Miller, Joseph S. Ross
Feasibility of weekly participant-reported data collection in a pragmatic randomised controlled trial in primary care: experiences from the BATHE trial (Bath Additives for the Treatment of cHildhood Eczema)
Beth Stuart, Kate Rumsby, Miriam Santer, Matthew J. Ridd, Nick A. Francis, Maria Chorozoglou, Carla Spreadbury, Mary Steele, Claire Nollett, Lyn Liddiard, Martina Prude, Julie Hooper, Emma Thomas-Jones, Amanda Roberts, Kim S. Thomas, Hywel C. Williams, Paul Little
Improving cooperation between general practitioners and dermatologists via telemedicine: study protocol of the cluster-randomized controlled TeleDerm study
Roland Koch, Andreas Polanc, Hannah Haumann, Gudula Kirtschig, Peter Martus, Christian Thies, Leonie Sundmacher, Carmen Gaa, Leonard Witkamp, Oliver Bertram, Lucien Clin, Sven Dörflinger, Claus Garbe, Thomas Eigentler, Heidrun Sturm, Janina Schubert, Tonia Brand, Katrin Tomaschko, Hans Leibfritz, Aaron Bakker, Job van der Heijden, Julia Frank-Tewaag, Matthias Wöhr, Anika Meissner, Matthias Möhrle, Sebastian Kauder, Markus Krug, Andreas Blum, Stefanie Joos
Improving trial recruitment processes: how qualitative methodologies can be used to address the top 10 research priorities identified within the PRioRiTy study
Marita Hennessy, Andrew Hunter, Patricia Healy, Sandra Galvin, Catherine Houghton
Comparing the effect of sucrose gel and metronidazole gel in treatment of clinical symptoms of bacterial vaginosis: a randomized controlled trial
Somayyeh Khazaeian, Ali Navidian, Shahin-dokht Navabi-Rigi, Marzieh Araban, Faraz Mojab, Safoura Khazaeian
TRACE (Routine posTsuRgical Anesthesia visit to improve patient outComE): a prospective, multicenter, stepped-wedge, cluster-randomized interventional study
Valérie M. Smit-Fun, Dianne de Korte-de Boer, Linda M. Posthuma, Annick Stolze, Carmen D. Dirksen, Markus W. Hollmann, Wolfgang F. Buhre, Christa Boer
Correction to: Effects of hemodynamic monitoring using a single-use transesophageal echocardiography probe in critically ill patients – study protocol for a randomized controlled trial
Luca Cioccari, Bjoern Zante, Andreas Bloch, David Berger, Andreas Limacher, Stephan M. Jakob, Jukka Takala, Tobias M. Merz
Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18–50 years) femoroacetabular impingement: a statistical analysis plan
Nicole Simunovic, D. Heels-Ansdell, L. Thabane, O. R. Ayeni, Olufemi R. Ayeni, Mohit Bhandari, Asheesh Bedi, Teppo Järvinen, Volker Musahl, Douglas Naudie, Matti Seppänen, Gerard Slobogean, Lehana Thabane, Nicole Simunovic, Andrew Duong, Matthew Skelly, Sheila Sprague, Diane Heels-Ansdell, Lisa Buckingham, Tim Ramsay, John Lee, Petteri Kousa, Sasha Carsen, Hema Choudur, Yan Sim, Kelly Johnston, Ivan Wong, Nicole Paquet, Jalisa Den Hartog, Daniel Whelan, Ryan Khan, Gavin C. A. Wood, Fiona Howells, Heather Grant, Bryn Zomar, Michael Pollock, Kevin Willits, Andrew Firth, Stacey Wanlin, Alliya Remtulla, Nicole Kaniki, Etienne L. Belzile, Sylvie Turmel, Mari Pirjetta Routapohja, Uffe Jørgensen, Annie Gam-Pedersen, Raine Sihvoenen, Marko Raivio, Pirjo Toivonen
Exploring qualitative methods reported in registered trials and their yields (EQUITY): systematic review
Clare Clement, Suzanne L. Edwards, Frances Rapport, Ian T. Russell, Hayley A. Hutchings
Photodynamic therapy with Bixa orellana extract and LED for the reduction of halitosis: study protocol for a randomized, microbiological and clinical trial
Marcela Leticia Leal Gonçalves, Ana Carolina Costa da Mota, Alessandro Melo Deana, Guelton Hirano Guedes, Lisyanne Araújo de Souza Cavalcante, Renato Araújo Prates, Anna Carolina Ratto Tempestini Horliana, Christiane Pavani, Lara Jansiski Motta, Greice de Brito Bitencourt, Kristianne Porta Santos Fernandes, Monica da Consolação Canuto Salgueiro, Raquel Agnelli Mesquita-Ferrari, Daniela Fátima Teixeira da Silva, Cristiane Miranda França, Sandra Kalil Bussadori
Reporting quality of randomized controlled trial abstracts in the seven highest-ranking anesthesiology journals
Katja Janackovic, Livia Puljak
Outcomes, Interventions and Funding in Randomised Research Published in High-Impact Journals
Patrick Grey, Andrew Grey, Mark J. Bolland
Traumatic injury clinical trial evaluating tranexamic acid in children (TIC-TOC): study protocol for a pilot randomized controlled trial
Daniel K. Nishijima, John VanBuren, Hilary A. Hewes, Sage R. Myers, Rachel M. Stanley, P. David Adelson, Sarah E. Barnhard, Matthew Bobinski, Simona Ghetti, James F. Holmes, Ian Roberts, Walton O. Schalick III, Nam K. Tran, Leah S. Tzimenatos, J. Michael Dean, Nathan Kuppermann, Marike Zwienenberg, Joseph Galante, Joseph Stephenson, Alfred F. Trappey, Jordan Sandhu, T. Charles Casper, Stephen Fenton, Doug Brockmeyer, Theodore Pysher, Michael L. Nance, Shih-Shan Lang Chen, Deborah Sesok-Pizzini, Raj Thakkar, Eric Sribnik, Kathleen Nichol
The Enhanced Mentor Mother ProgrAm (EMMA) for the prevention of mother-to-child transmission of HIV in Kenya: study protocol for a cluster randomized controlled trial
Bruce A. Larson, Margaret Bii, Isaac Tsikhutsu, Nafisa Halim, Vanessa Wolfman, Peter Coakley, William Sugut, Fredrick Sawe
EPURE Transplant (Eplerenone in Patients Undergoing Renal Transplant) study: study protocol for a randomized controlled trial
Sophie Girerd, Luc Frimat, Didier Ducloux, Yannick Le Meur, Christophe Mariat, Bruno Moulin, Christiane Mousson, Philippe Rieu, Nassim Dali-Youcef, Ludovic Merckle, Xavier Lepage, Patrick Rossignol, Nicolas Girerd, Frédéric Jaisser
A novel integrated dressing to secure peripheral intravenous catheters in an adult acute hospital: a pilot randomised controlled trial
Nicole Marsh, Emily Larsen, Jodie Genzel, Gabor Mihala, Amanda J. Ullman, Tricia Kleidon, Sue Cadigan, Claire M. Rickard
Functional and systemic effects of whole body electrical stimulation post bariatric surgery: study protocol for a randomized controlled trial
Larissa Delgado André, Renata P. Basso-Vanelli, Luciana Di Thommazo-Luporini, Paula Angélica Ricci, Ramona Cabiddu, Soraia Pilon Jürgensen, Claudio Ricardo de Oliveira, Ross Arena, Audrey Borghi-Silva
Protocol for a randomised controlled trial of cognitive bias modification training during inpatient withdrawal from alcohol use disorder
Victoria Manning, Joshua B. B. Garfield, Samuel C. Campbell, John Reynolds, Petra K. Staiger, Jarrad A. G. Lum, Kate Hall, Reinout W. Wiers, Dan I. Lubman, Antonio Verdejo-Garcia
Laser hair depilation for the prevention of disease recurrence in adolescents and young adults with pilonidal disease: study protocol for a randomized controlled trial
Peter C. Minneci, Devin R. Halleran, Amy E. Lawrence, Beth A. Fischer, Jennifer N. Cooper, Katherine J. Deans
Electrically guided versus imaging-guided implant of the left ventricular lead in cardiac resynchronization therapy: a study protocol for a double-blinded randomized controlled clinical trial (ElectroCRT)
Charlotte Stephansen, Anders Sommer, Mads Brix Kronborg, Jesper Møller Jensen, Kirsten Bouchelouche, Jens Cosedis Nielsen
Acupuncture and clomiphene for Chinese women with polycystic ovary syndrome (PCOSAct): statistical analysis approach with the revision and explanation
Hong-Li Ma, Liang-Zhen Xie, Jing-Shu Gao, Jing Cong, Ying-Ying Deng, Ernest H. Y. Ng, Jian-Ping Liu, Xiao-Ke Wu
Comparison of two supplement oxygen methods during gastroscopy with intravenous propofol anesthesia in obese patients: study protocol for a randomized controlled trial
Liu-Jia-Zi Shao, Shao-Hua Liu, Fu-Kun Liu, Yi Zou, Hai-Jun Hou, Ming Tian, Fu-Shan Xue
Fluoroscopy with MRA fusion image guidance in endovascular iliac artery interventions: study protocol for a randomized controlled trial (3DMR-Iliac-roadmapping study)
Seline R. Goudeketting, Stefan G. H. Heinen, Michiel W. de Haan, Anna M. Sailer, Daniel A. F. van den Heuvel, Marco J. van Strijen, Jean-Paul P. M. de Vries
Statistical analysis plan of a randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy (SECURE trial)
Sarah Z. Wennmacker, Aafke H. van Dijk, Joost P. H. Drenth, Sandra C. Donkervoort, Djamila Boerma, Gert P. Westert, Cornelis J. H. M. van Laarhoven, Marja A. Boermeester, Marcel G. W. Dijkgraaf, Philip R. de Reuver
New guidance to improve sample size calculations for trials: eliciting the target difference
Melanie L. Bell
DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial
Jonathan A. Cook, Steven A. Julious, William Sones, Lisa V. Hampson, Catherine Hewitt, Jesse A. Berlin, Deborah Ashby, Richard Emsley, Dean A. Fergusson, Stephen J. Walters, Edward C. F. Wilson, Graeme Maclennan, Nigel Stallard, Joanne C. Rothwell, Martin Bland, Louise Brown, Craig R. Ramsay, Andrew Cook, David Armstrong, Doug Altman, Luke D. Vale
Safety and efficacy of applying sufficient analgesia combined with a minimal sedation program as an early antihypertensive treatment for spontaneous intracerebral hemorrhage: a randomized controlled trial
Rui Dong, Fen Li, Ying Xu, Pingyan Chen, Marc Maegele, Hong Yang, Wenjin Chen
Low-dose aspirin in the prevention of pre-eclampsia in China (APPEC study): protocol for a multicentre randomized controlled trial
Li Lin, Yuchun Zhu, Boya Li, Huixia Yang, Xiaotian Li, Yangyu Zhao, Dunjin Chen, Hongbo Qi, Weishe Zhang, Hongjuan Ding, Meihua Zhang, Xianlan Zhao, Shihong Cui, Yang Mi, Xiaotong Sun, Yuyan Ma
Evaluating interventions for informed consent for surgery (ICONS): Protocol for the development of a core outcome set
Liam J. Convie, Scott McCain, Jeffrey Campbell, Stephen J. Kirk, Mike Clarke
Malaria chemoprevention with monthly dihydroartemisinin-piperaquine for the post-discharge management of severe anaemia in children aged less than 5 years in Uganda and Kenya: study protocol for a multi-centre, two-arm, randomised, placebo-controlled, superiority trial
Titus K. Kwambai, Aggrey Dhabangi, Richard Idro, Robert Opoka, Simon Kariuki, Aaron M. Samuels, Meghna Desai, Michael Boele van Hensbroek, Chandy C. John, Bjarne Robberstad, Duolao Wang, Kamija Phiri, Feiko O. ter Kuile
Effects of recombinant human erythropoietin on cognition and neural activity in remitted patients with mood disorders and first-degree relatives of patients with psychiatric disorders: a study protocol for a randomized controlled trial
Jeff Zarp Petersen, Lejla Sjanic Schmidt, Maj Vinberg, Martin Balslev Jørgensen, Ida Hageman, Hannelore Ehrenreich, Gitte Moos Knudsen, Lars Vedel Kessing, Kamilla Woznica Miskowiak
Early mobilisation by head-up tilt with stepping versus standard care after severe traumatic brain injury – Protocol for a randomised clinical feasibility trial
Christian Gunge Riberholt, Jane Lindschou, Christian Gluud, Jesper Mehlsen, Kirsten Møller
MAPLE-PD trial (Mesenteric Approach vs. Conventional Approach for Pancreatic Cancer during Pancreaticoduodenectomy): study protocol for a multicenter randomized controlled trial of 354 patients with pancreatic ductal adenocarcinoma
Seiko Hirono, Manabu Kawai, Ken-ichi Okada, Tsutomu Fujii, Masayuki Sho, Sohei Satoi, Ryosuke Amano, Hidetoshi Eguchi, Yuko Mataki, Masafumi Nakamura, Ippei Matsumoto, Hideo Baba, Masaji Tani, Yasunari Kawabata, Yuichi Nagakawa, Suguru Yamada, Yoshiaki Murakami, Toshio Shimokawa, Hiroki Yamaue
GRam stain-guided Antibiotics ChoicE for Ventilator-Associated Pneumonia (GRACE-VAP) trial: rationale and study protocol for a randomised controlled trial
Jumpei Yoshimura, Kazuma Yamakawa, Takahiro Kinoshita, Yoshinori Ohta, Takeshi Morimoto
Art therapy is associated with sustained improvement in cognitive function in the elderly with mild neurocognitive disorder: findings from a pilot randomized controlled trial for art therapy and music reminiscence activity versus usual care
Rathi Mahendran, Mihir Gandhi, Rajesh Babu Moorakonda, Jonathan Wong, Madhu Mathi Kanchi, Johnson Fam, Iris Rawtaer, Alan Prem Kumar, Lei Feng, Ee Heok Kua
ALternatives To prophylactic Antibiotics for the treatment of Recurrent urinary tract infection in women (ALTAR): study protocol for a multicentre, pragmatic, patient-randomised, non-inferiority trial
Rebecca Forbes, Ased Ali, Alaa Abouhajar, Catherine Brennand, Heather Brown, Sonya Carnell, Thomas Chadwick, Ian Eardley, Jan Lecouturier, Helen Mossop, Ian Pearce, Robert Pickard, Nikesh Thiruchelvam, Katherine Walton, Jennifer Wilkinson, Chris Harding
Preloop trial: study protocol for a randomized controlled trial
Elisa Mäkäräinen-Uhlbäck, Heikki Wiik, Jyrki Kössi, Pasi Ohtonen, Tero Rautio
A recommender system to quit smoking with mobile motivational messages: study protocol for a randomized controlled trial
Santiago Hors-Fraile, Shwetambara Malwade, Dimitris Spachos, Luis Fernandez-Luque, Chien-Tien Su, Wei-Li Jeng, Shabbir Syed-Abdul, Panagiotis Bamidis, Yu-Chuan(Jack) Li
RIVA – a phase IIa study of rituximab and varlilumab in relapsed or refractory B-cell malignancies: study protocol for a randomized controlled trial
Sean H. Lim, Kim M. Linton, Graham P. Collins, Joke Dhondt, Joshua Caddy, Liz Rossiter, Karan Vadher, Keira Fines, Laura E. Rogers, Diana Fernando, Louise Stanton, Andrew J. Davies, Peter W. M. Johnson, Gareth Griffiths
Integrated traditional Chinese and conventional medicine in treatment of severe community-acquired pneumonia: study protocol for a randomized placebo-controlled trial
Haifeng Wang, Jiansheng Li, Xueqing Yu, Su-yun Li
Exploring factors associated with views on sharing of certain interim trial result measures by the data safety monitoring board (DSMB) with non-DSMB members
Victoria Borg Debono, Lawrence Mbuagbaw, James Paul, Norman Buckley, Lehana Thabane
Premature ejaculation in primary care: communication strategies versus usual care for male patients consulting for a sexual, urogenital or psychological reason – GET UP: study protocol for a cluster randomised controlled trial
Marie Barais, Hélène Vaillant Roussel, David Costa, Jérémy Derriennic, Bruno Pereira, Sébastien Cadier
Functional brain activation changes associated with practice in delaying smoking among moderate to heavy smokers: study protocol and rationale of a randomized trial (COPE)
Andrew T. Fox, Delwyn Catley, Kimber P. Richter, Edward F. Ellerbeck, Morgan G. Brucks, Vlad B. Papa, Laura E. Martin
A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS): study protocol for a randomized controlled trial
David Lagier, François Fischer, William Fornier, Jean-Luc Fellahi, Pascal Colson, Bernard Cholley, Samir Jaber, Karine Baumstarck, Catherine Guidon, David Lagier, Gabrielle Quintana, Françoise Gaillat, Patrice Nedir, Raphaelle Duponq, Romain Gomert, Benoit Guinard, Florent Heraud, Catherine Guidon, Judith Villacorta, Su Degirmenci, Nicolas Pernoud, Pascal Colson, Gianluca Samarani, Marion Lalande, Jean-Luc Fellahi, William Fornier, Bernard Cholley, Thi Mum Huynh, François Fischer, Cecile Gros, Faycal Elmiloudi, Charles Tacquard, Audrey Bilger, François Levy, Ecaterina Cinca, Clément Bongarzone, Bob Heger, Victor Balvay, Marjory Berns, Walid Oulehri, Alexandre Ouattara
Assessing the value of eHealth for bariatric surgery (BePatient trial): study protocol for a randomized controlled trial
Dirk P. A. Versteegden, Magaly J. J. Van himbeeck, Simon W. Nienhuijs
A double-blind, randomized, placebo-controlled trial of a computer-based Interpretation Bias Training for youth with severe irritability: a study protocol
Simone P. Haller, Joel Stoddard, Caroline MacGillivray, Kelsey Stiles, Gretchen Perhamus, Ian S. Penton-Voak, Yair Bar-Haim, Marcus R. Munafò, Melissa A. Brotman
Non-invasive ventilation for the management of children with bronchiolitis (NOVEMBR): a feasibility study and core outcome set development protocol
Clare van Miert, Ricardo M. Fernandes, Helen Eccleson, Emma Bedson, Steven Lane, Matthew Peak, Kent Thorburn, Vanessa Compton, Kerry Woolfall, David Lacy, Paula Williamson, Paul S. McNamara
Low-chloride versus high-chloride hypertonic solution for the treatment of subarachnoid hemorrhage-related complications (The ACETatE trial): study protocol for a pilot randomized controlled trial
Ofer Sadan, Owen Samuels, William H. Asbury, John J. Hanfelt, Kai Singbartl
Motivational Interviewing as a tool to enhance access to mental health treatment in adolescents with chronic medical conditions and need for psychological support (COACH-MI): study protocol for a clusterrandomised controlled trial
Christina Reinauer, Rabea Viermann, Katharina Förtsch, Hannah Linderskamp, Petra Warschburger, Reinhard W. Holl, Doris Staab, Kirsten Minden, Rainer Muche, Matthias Domhardt, Harald Baumeister, Thomas Meissner
Recruitment of patients with de novo Parkinson disease: successful strategies in a randomized exercise clinical trial
Deborah A. Hall, Charity Moore, Cynthia Comella, B. Berman, C. L. Christiansen, B. Kluger, W. M. Kohrt, Ed Melanson, M. Schenkman, C. G. Moore, D. M. Corcos, C. Poon, A. Delitto, D. A. Josbeno, S. Jain
Decreasing the use of edible oils in China using WeChat and theories of behavior change: study protocol for a randomized controlled trial
Rui Zhu, Xianglong Xu, Yong Zhao, Manoj Sharma, Zumin Shi
A randomized controlled trial comparing lifestyle intervention to letrozole for ovulation in women with polycystic ovary syndrome: a study protocol
Dylan A. Cutler, Alana K. Shaw, Sheila M. Pride, Mohamed A. Bedaiwy, Anthony P. Cheung
Does a Screening Trial for Spinal Cord Stimulation in Patients with Chronic Pain of Neuropathic Origin have Clinical Utility and Cost-Effectiveness? (TRIAL-STIM Study): study protocol for a randomised controlled trial
Sam Eldabe, Ashish Gulve, Simon Thomson, Ganesan Baranidharan, Rui Duarte, Susan Jowett, Harbinder Sandhu, Raymond Chadwick, Morag Brookes, Anisah Tariq, Jenny Earle, Jill Bell, Anu Kansal, Shelley Rhodes, Rod S. Taylor
Effect of a high-protein diet with β-cryptoxanthin supplementation on metabolic risk factors, oxidative and inflammatory biomarkers in non-alcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled clinical trial
Fatemeh Haidari, Abdollah Hojhabrimanesh, Bizhan Helli, Seyed Saeid Seyedian, Kambiz Ahmadi-Angali
A core outcome set for clinical trials in whiplash-associated disorders (WAD): a study protocol
Annick Maujean, Linda Carroll, Michele Curatolo, James Elliott, Helge Kasch, David Walton, Michele Sterling
Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study)
Daniel Sganzerla, Cassiano Teixeira, Caroline Cabral Robinson, Renata Kochhann, Mariana Martins Siqueira Santos, Rafaela Moraes de Moura, Mirceli Goulart Barbosa, Daiana Barbosa da Silva, Tarissa Ribeiro, Cláudia Eugênio, Daniel Schneider, Débora Mariani, Rodrigo Wiltgen Jeffman, Fernando Bozza, Alexandre Biasi Cavalcanti, Luciano Cesar Pontes Azevedo, Flávia Ribeiro Machado, Jorge Ibrain Salluh, José Augusto Santos Pellegrini, Rafael Barberena Moraes, Lucas Petri Damiani, Nilton Brandão da Silva, Maicon Falavigna, Regis Goulart Rosa
Landiolol in patients with septic shock resident in an intensive care unit (LANDI-SEP): study protocol for a randomized controlled trial
Martin Unger, Andrea Morelli, Mervyn Singer, Peter Radermacher, Sebastian Rehberg, Helmut Trimmel, Michael Joannidis, Gottfried Heinz, Vladimír Cerny, Pavel Dostál, Christian Siebers, Fabio Guarracino, Francesca Pratesi, Gianni Biancofiore, Massimo Girardis, Pavla Kadlecova, Olivier Bouvet, Michael Zörer, Barbara Grohmann-Izay, Kurt Krejcy, Christoph Klade, Günther Krumpl
COmmunity-based Rehabilitation after Knee Arthroplasty (CORKA): statistical analysis plan for a randomised controlled trial
Karan Vadher, Ruth Knight, Karen L. Barker, Susan J. Dutton
“Stroke - 65 Plus. Continued Active Life”: a study protocol for a randomized controlled cross-sectoral trial of the effect of a novel self-management intervention to support elderly people after stroke
Hanne Pallesen, Erhard Trillingsgaard Næss-Schmidt, Simon Svanborg Kjeldsen, Sedsel Kristine Stage Pedersen, Susanne Lillelund Sørensen, Iris Brunner, Jørgen Feldbæk Nielsen
Reducing Implant Infection in Orthopaedics (RIIiO): a pilot study for a randomised controlled trial comparing the influence of forced air versus resistive fabric warming technologies on postoperative infection rates following orthopaedic implant surgery in adults
Michelle Kümin, Christopher Mark Harper, Mike Reed, Stephen Bremner, Nicky Perry, Matthew Scarborough
Effects of the birthing room environment on vaginal births and client-centred outcomes for women at term planning a vaginal birth: BE-UP, a multicentre randomised controlled trial
Gertrud M. Ayerle, Rainhild Schäfers, Elke Mattern, Sabine Striebich, Burkhard Haastert, Markus Vomhof, Andrea Icks, Yvonne Ronniger, Gregor Seliger
Adaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine Agency
Olivier Collignon, Franz Koenig, Armin Koch, Robert James Hemmings, Frank Pétavy, Agnès Saint-Raymond, Marisa Papaluca-Amati, Martin Posch
A multi-centre, double-blind, placebo-controlled, randomised trial of combination methotrexate and gefitinib versus methotrexate alone to treat tubal ectopic pregnancies (GEM3): trial protocol
James May, Colin Duncan, Ben Mol, Siladitya Bhattacharya, Jane Daniels, Lee Middleton, Catherine Hewitt, Arri Coomarasamy, Davor Jurkovic, Tom Bourne, Cecilia Bottomley, Alexandra Peace-Gadsby, Ann Doust, Stephen Tong, Andrew W. Horne
The U&I study: study protocol for a feasibility randomised controlled trial of a pre-cognitive behavioural therapy digital ‘informed choice’ intervention to improve attitudes towards uptake and implementation of CBT for psychosis
Kathryn Greenwood, Katie Alford, Iain O’Leary, Emmanuelle Peters, Amy Hardy, Kate Cavanagh, Andy P. Field, Richard de Visser, David Fowler, Matthew Davies, Alexandra Papamichail, Philippa Garety
High-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease (HAPPEN): study protocol for a multicenter randomized controlled trial
Zujin Luo, Chao Wu, Qi Li, Jian Zhu, Baosen Pang, Yan Shi, Yingmin Ma, Zhixin Cao, Baosen Pang, Bing Dai, Bing Sun, Chao Wu, Chao Zhang, Chen Liu, Dan Wang, Dawei Zheng, Dongmei Li, Fucheng An, Hangyong He, Heli Wang, Hongmei Wu, Hongru Liu, Huiqing Ge, Jian Zhu, Jing Zhou, Juan Wang, Kailiang Duan, Kailv Wang, Lianxiang Guo, Lin Chen, Ling Yu, Lirong Liang, Lixin Xie, Longguang Wu, Lujiang Li, Manyan Zhang, Mingdong Hu, Mingwei Chen, Panpan Zhang, Pengfei Li, Qi Li, Qian Li, Qiang Dang, Qingyuan Zhan, Rongbo Wang, Rui Sun, Runxia Shao, Sanhong Zhang, Shengyu Wang, Sijie Liu, Tianjun Chen, Wenshuai Feng, Wujie Lu, Xiaohong Yang, Xiaohua Hou, Xiaoping Zhang, Xiaowu Tan, Xinghui Wu, Xiuhong Jing, Xiuhong Ma, Xiuzhi Yang, Yaoming Hu, Yichong Li, Yingmin Ma, Yonghong Xiang, Yongpeng An, Yongxiang Zhang, Yunhui Lv, Yurong Zhang, Zhaohui Tong, Zhifang Liu, Zhijun Feng, Zhixin Cao, Zhiyang Yin, Zujin Luo
Financial IncEntives for Smoking TreAtment: protocol of the FIESTA trial and FIESTA Oral Microbiome Substudy
Katherine M. French, Sasha Z. Gonzalez, Scott E. Sherman, Alissa R. Link, Sadozai Zoe Malik, Chi-Hong Tseng, Saahil A. Jumkhawala, Briesny Tejada, Andrew White, Joseph A. Ladapo
Investigating the effectiveness and feasibility of exercise on microvascular reactivity and quality of life in systemic sclerosis patients: study protocol for a feasibility study
Alexandros Mitropoulos, Anil Gumber, Helen Crank, Mohammed Akil, Markos Klonizakis
mHealth smoking cessation intervention among high-school pupils (NEXit Junior): study protocol for a randomized controlled trial
Kristin Thomas, Marcus Bendtsen, Catharina Linderoth, Ulrika Müssener
AMBIsome Therapy Induction OptimisatioN (AMBITION): High Dose AmBisome for Cryptococcal Meningitis Induction Therapy in sub-Saharan Africa: Study Protocol for a Phase 3 Randomised Controlled Non-Inferiority Trial
David S. Lawrence, Nabila Youssouf, Síle F. Molloy, Alexandre Alanio, Melanie Alufandika, David R. Boulware, Timothée Boyer-Chammard, Tao Chen, Francoise Dromer, Admire Hlupeni, William Hope, Mina C. Hosseinipour, Cecilia Kanyama, Oliver Lortholary, Angela Loyse, David B. Meya, Mosepele Mosepele, Conrad Muzoora, Henry C. Mwandumba, Chiratidzo E. Ndhlovu, Louis Niessen, Charlotte Schutz, Katharine E. Stott, Duolao Wang, David G. Lalloo, Graeme Meintjes, Shabbar Jaffar, Thomas S. Harrison, Joseph N. Jarvis
Improving eye care in residential aged care facilities using the Residential Ocular Care (ROC) model: study protocol for a multicentered, prospective, customized, and cluster randomized controlled trial in Australia
Edith E. Holloway, Marios Constantinou, Jing Xie, Eva K. Fenwick, Eric A. Finkelstein, Ryan E. K. Man, Michael Coote, Jonathan Jackson, Gwyn Rees, Ecosse L. Lamoureux
Rapid agitation control with ketamine in the emergency department (RACKED): a randomized controlled trial protocol
David Barbic, Gary Andolfatto, Brian Grunau, Frank X. Scheuermeyer, William MacEwan, William G. Honer, Hubert Wong, Skye P. Barbic
Evaluation of different doses of transcutaneous nerve stimulation for pain relief during labour: a randomized controlled trial
Aníbal Báez-Suárez, Estela Martín-Castillo, Josué García-Andújar, José Ángel García-Hernández, María P. Quintana-Montesdeoca, Juan Francisco Loro-Ferrer
Bias due to MEasurement Reactions In Trials to improve health (MERIT): protocol for research to develop MRC guidance
Lisa M. Miles, Diana Elbourne, Andrew Farmer, Martin Gulliford, Louise Locock, Jim McCambridge, Stephen Sutton, David P. French
Positive end-expiratory pressure (PEEP) level to prevent expiratory flow limitation during cardiac surgery: study protocol for a randomized clinical trial (EFLcore study)
Elena Bignami, Savino Spadaro, Francesco Saglietti, Antonio Di Lullo, Francesca Dalla Corte, Marcello Guarnieri, Giulio de Simone, Ilaria Giambuzzi, Alberto Zangrillo, Carlo Alberto Volta
Development of a Core Outcome Set for Studies on Obesity in Pregnant Patients (COSSOPP): a study protocol
Rachel Dadouch, Mina Faheim, Clara Juando-Prats, Janet Parsons, Rohan D’Souza
An analysis of reporting quality of prospective studies examining community antibiotic use and resistance
Mina Bakhit, Chris Del Mar, Anna Mae Scott, Tammy Hoffmann
Ursodeoxycholic acid versus placebo in the treatment of women with intrahepatic cholestasis of pregnancy (ICP) to improve perinatal outcomes: protocol for a randomised controlled trial (PITCHES)
Lucy C. Chappell, Jenny Chambers, Peter H. Dixon, Jon Dorling, Rachael Hunter, Jennifer L. Bell, Ursula Bowler, Pollyanna Hardy, Edmund Juszczak, Louise Linsell, Catherine Rounding, Anne Smith, Catherine Williamson, Jim G. Thornton
Statistical analysis plan for the control of blood pressure and risk attenuation-rural Bangladesh, Pakistan, Sri Lanka (COBRA-BPS) trial: a cluster randomized trial for a multicomponent intervention versus usual care in hypertensive patients
Mihir Gandhi, Pryseley Nkouibert Assam, Elizabeth L. Turner, Donald E. Morisky, Edwin Chan, Tazeen H. Jafar
ACTonHEALTH study protocol: promoting psychological flexibility with activity tracker and mHealth tools to foster healthful lifestyle for obesity and other chronic health conditions
Roberto Cattivelli, Gianluca Castelnuovo, Alessandro Musetti, Giorgia Varallo, Chiara A. M. Spatola, Francesco Vailati Riboni, Anna Guerrini Usubini, Fabio Tosolin, Gian Mauro Manzoni, Paolo Capodaglio, Alessandro Rossi, Giada Pietrabissa, Enrico Molinari
The efficacy of adding group behavioral activation to usual care in patients with fibromyalgia and major depression: design and protocol for a randomized clinical trial
Lydia Gómez-Pérez, Alvaro Vergés, Ana Rocío Vázquez-Taboada, Josefina Durán, Matías González Tugas
Effects of transcranial direct current stimulation on gait in people with Parkinson’s disease: study protocol for a randomized, controlled clinical trial
Vida Alizad, Marcus Meinzer, Laurent Frossard, Remco Polman, Simon Smith, Graham Kerr
Efficacy and safety of Ojeok-san in Korean female patients with cold hypersensitivity in the hands and feet: study protocol for a randomized, double-blinded, placebo-controlled, multicenter pilot study
Youme Ko, Ho-Yeon Go, In-Sik Han, Kyou-Young Lee, Tae-Hoon Kim, Jin-Moo Lee, Jun-Bok Jang, Yun-Kyung Song, Seung-Ho Sun, Chan-Yong Jeon, Seong-Gyu Ko
Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial
Ho Jeong Do, Joon-Shik Shin, Jinho Lee, Yoon Jae Lee, Me-riong Kim, Jae-Heung Cho, Koh-Woon Kim, In-Hyuk Ha
A cluster randomised trial of a classroom communication resource program to change peer attitudes towards children who stutter among grade 7 students
Rizwana Mallick, Harsha Kathard, A. S. M. Borhan, Mershen Pillay, Lehana Thabane
Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study
Ulrike Schierloh, Gloria A. Aguayo, Muriel Fichelle, Cindy De Melo Dias, Aljosa Celebic, Michel Vaillant, Katharine Barnard, Ohad Cohen, Carine de Beaufort
A multicenter, randomized controlled comparison of three renutrition strategies for the management of moderate acute malnutrition among children aged from 6 to 24 months (the MALINEA project)
Muriel Vray, Boris G. Hedible, Pierrick Adam, Laura Tondeur, Alexandre Manirazika, Rindra Randremanana, Halima Mainassara, André Briend, Cecile Artaud, Cassandre von Platen, Mathias Altmann, Ronan Jambou
Tailored axillary surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS): study protocol for a multicenter, randomized phase-III trial
Guido Henke, Michael Knauer, Karin Ribi, Stefanie Hayoz, Marie-Aline Gérard, Thomas Ruhstaller, Daniel R. Zwahlen, Simone Muenst, Markus Ackerknecht, Hanne Hawle, Florian Fitzal, Michael Gnant, Zoltan Mátrai, Bettina Ballardini, Andreas Gyr, Christian Kurzeder, Walter P. Weber
Efficacy and cost-effectiveness of a community-based model of care for older patients with complex needs: a study protocol for a multicentre randomised controlled trial using a stepped wedge cluster design
Irina Kinchin, Susan Jacups, Jennifer Mann, Rachel Quigley, Desley Harvey, Christopher M. Doran, Edward Strivens
Effect of dual-acupoint and single-acupoint electric stimulation on postoperative outcomes in elderly patients subjected to gastrointestinal surgery: study protocol for a randomized controlled trial
Zhi-hong Lu, Hai-long Dong, Jia-wen Huang-fu, Xiao-jian Fan, Wei-xian Zhao, Su Min, Wei Zhang, Ming-fu Liu, Yong-hui Wang, Li-ni Wang, Li-ze Xiong
Dexamethasone for adult patients with a symptomatic chronic subdural haematoma (Dex-CSDH) trial: study protocol for a randomised controlled trial
Angelos G. Kolias, Ellie Edlmann, Eric P. Thelin, Diederik Bulters, Patrick Holton, Nigel Suttner, Kevin Owusu-Agyemang, Yahia Z. Al-Tamimi, Daniel Gatt, Simon Thomson, Ian A. Anderson, Oliver Richards, Peter Whitfield, Monica Gherle, Karen Caldwell, Carol Davis-Wilkie, Silvia Tarantino, Garry Barton, Hani J. Marcus, Aswin Chari, Paul Brennan, Antonio Belli, Simon Bond, Carole Turner, Lynne Whitehead, Ian Wilkinson, Peter J. Hutchinson, Khaled Badran, Ian Coulter, Mathew J. Gallagher, Florence R. A. Hogg, Catherine Pringle, Adam Razak, Hamzah Soleiman, Rory Piper, Emma Toman, Marian Vintu, Adam Wahba, Anthony Wiggins, Kamal Makram Yakoub, Malik Zaben, Ardalan Zolnouria, Peter Bodkin, Emanuel Cirstea, Giles Critchley, Charlotte Eglinton, Louise Finlay, Daniela Georgieva, Nihal Gurusinghe, Nikolaos Haliasos, Damian Holliman, Kismet Hossain-Ibrahim, Masood Hussain, Jothy Kandasamy, Mary Kambafwile, Phillip Kane, Dipankar Nandi, Ravindra Nannapaneni, Laura Ortiz-Ruiz de Gordoa, Marios C. Papadopoulos, Dimitris Paraskevopoulos, Jash Patel, Manjunath Prasad, Nikolaos Tzerakis, Carol Brayne, Andrew Gardner, Andrew King, Kate Massey, Thais Minett, Patrick Mitchell, Phyo Myint, Elizabeth Warburton, Anthony Bell, Allison Hirst, Laurence Watkins, Peter McCabe, Martin Smith, Joan Grieve, Jonathan Cook
Assessment of chiropractic care on strength, balance, and endurance in active-duty U.S. military personnel with low back pain: a protocol for a randomized controlled trial
Robert Vining, Amy Minkalis, Cynthia R. Long, Lance Corber, Crystal Franklin, M. Ram Gudavalli, Ting Xia, Christine M. Goertz
Efficacy and safety of polydioxanone thread embedded at specific acupoints for non-specific chronic neck pain: a study protocol for a randomized, subject-assessor-blinded, sham-controlled pilot trial
Eunseok Kim, Hye Su Kim, So-Young Jung, Chang Hyun Han, Young-Il Kim
Improving overall health of children living with HIV through an oral health intervention in Cambodia: study protocol for a randomized controlled trial
Kimiyo Kikuchi, Junko Yasuoka, Sovannary Tuot, Sokunthea Yem, Pheak Chhoun, Sumiyo Okawa, Makoto Murayama, Chantheany Huot, Siyan Yi
Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials
Jeremy Howick, Rebecca Webster, Nigel Kirby, Kerry Hood
Single high-dose buprenorphine for opioid craving during withdrawal
Jamshid Ahmadi, Mina Sefidfard Jahromi, Dara Ghahremani, Edythe D. London
Prevention of Early Postoperative Decline (PEaPoD): protocol for a randomized, controlled feasibility trial
Brian O’Gara, Edward R. Marcantonio, Alvaro Pascual-Leone, Shahzad Shaefi, Ariel Mueller, Valerie Banner-Goodspeed, Daniel Talmor, Balachundhar Subramaniam
Correction to: The U&I study: study protocol for a feasibility randomised controlled trial of a pre-cognitive behavioural therapy digital ‘informed choice’ intervention to improve attitudes towards uptake and implementation of CBT for psychosis
Kathryn Greenwood, Katie Alford, Iain O’Leary, Emmanuelle Peters, Amy Hardy, Kate Cavanagh, Andy P. Field, Richard de Visser, David Fowler, Matthew Davies, Alexandra Papamichail, Philippa Garety
Supporting breast cancer screening decisions for caregivers of older women with dementia: study protocol for a randomized controlled trial
Nicole R. Fowler, Mara A. Schonberg, Greg A. Sachs, Peter H. Schwartz, Sujuan Gao, Kathleen A. Lane, Lev Inger, Alexia M. Torke
Efficacy of 8 mg lidocaine and 2 mg cetylpyridinium chloride (CPC) fixed-combination lozenges on sore throat pain intensity compared with 1 mg lidocaine and 2 mg CPC fixed-combination lozenges in subjects with sore throat due to upper respiratory tract infection: a randomized double-blind parallel-group single-dose study
Frank Donath, Pascal Mallefet, Stephen Garreffa, Rowland Furcha
Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial
Hyun-Jong Lee, Byung Il Choi, Seungah Jun, Mu Seob Park, Se Jung Oh, Jung Hee Lee, Han Mi Gong, Jae Soo Kim, Young Joon Lee, So-Young Jung, Chang Hyun Han
VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT: study protocol for a randomized controlled trial (VENUS trial)
Hyung Jung Oh, Jung Nam An, Sohee Oh, Harin Rhee, Jung Pyo Lee, Dong Ki Kim, Dong-Ryeol Ryu, Sejoong Kim
Baby Steps – a structured group education programme with accompanying mobile web application designed to promote physical activity in women with a history of gestational diabetes: study protocol for a randomised controlled trial
Nithya Sukumar, Helen Dallosso, Ponnusamy Saravanan, Tom Yates, Carol Telling, Karen Shorthose, Alison Northern, Sally Schreder, Christopher Brough, Laura J. Gray, Melanie J. Davies, Kamlesh Khunti
A multicentre, randomized, controlled open-label trial to compare an Accelerated Rule-Out protocol using combined prehospital copeptin and in-hospital high sensitive troponin with standard rule-out in patients suspected of acute Myocardial Infarction – the AROMI trial
Claus Kjær Pedersen, Carsten Stengaard, Hanne Søndergaard, Karen Kaae Dodt, Jakob Hjort, Morten Thingemann Bøtker, Christian Juhl Terkelsen
Effect of a home-based exercise program on functional mobility and quality of life in elderly people: protocol of a single-blind, randomized controlled trial
Glauber Sá Brandão, Luís Vicente Franco Oliveira, Glaudson Sá Brandão, Anderson Soares Silva, Antônia Adonis Callou Sampaio, Jessica Julioti Urbano, Alyne Soares, Newton Santos Faria Jr, Luisa Teixeira Pasqualotto, Ezequiel Fernandes Oliveira, Rodrigo Franco Oliveira, Deise A. A. Pires-Oliveira, Aquiles Assunção Camelier
Central mechanisms of real and sham electroacupuncture in the treatment of chronic low back pain: study protocol for a randomized, placebo-controlled clinical trial
Jiang-Ti Kong, Brandon MacIsaac, Ruti Cogan, Amanda Ng, Christine Sze Wan Law, Joseph Helms, Rosa Schnyer, Nicholas Vasilis Karayannis, Ming-Chih Kao, Lu Tian, Beth D. Darnall, James J. Gross, Sean Mackey, Rachel Manber
Correction to: Mobile Link – a theory-based messaging intervention for improving sexual and reproductive health of female entertainment workers in Cambodia: study protocol of a randomized controlled trial
Carinne Brody, Sovannary Tuot, Pheak Chhoun, Dallas Swendenman, Kathryn C. Kaplan, Siyan Yi
Methods in the design and implementation of the Randomized Evaluation of Sedation Titration for Respiratory Failure (RESTORE) clinical trial
Martha A. Q. Curley, Rainer G. Gedeit, Brenda L Dodson, June K. Amling, Deborah J. Soetenga, Christiane O. Corriveau, Lisa A. Asaro, David Wypij
Prevention of Infections in Cardiac Surgery study (PICS): study protocol for a pragmatic cluster-randomized factorial crossover pilot trial
Rachel B. van Oostveen, Alberto Romero-Palacios, Richard Whitlock, Shun Fu Lee, Stuart Connolly, Alex Carignan, C. David Mazer, Mark Loeb, Dominik Mertz
A randomized controlled trial testing a hyaluronic acid spacer injection for skin toxicity reduction of brachytherapy accelerated partial breast irradiation (APBI): a study protocol
Gerson M. Struik, Jeremy Godart, Gerda M. Verduijn, Inger-Karine Kolkman-Deurloo, Kim C. de Vries, Raymond de Boer, Linetta B. Koppert, Erwin Birnie, Ali Ghandi, Taco M. Klem, Jean-Philippe Pignol
Prevention of post-operative complications by using a HMG-CoA reductase inhibitor in patients undergoing one-lung ventilation for non-cardiac surgery: study protocol for a randomised controlled trial
Murali Shyamsundar, Cecilia O’Kane, Gavin D. Perkins, Gavin Kennedy, Christina Campbell, Ashley Agus, Glenn Phair, Danny McAuley
Structured diet and exercise guidance in pregnancy to improve health in women and their offspring: study protocol for the Be Healthy in Pregnancy (BHIP) randomized controlled trial
Maude Perreault, Stephanie A. Atkinson, Michelle F. Mottola, Stuart M. Phillips, Keyna Bracken, Eileen K. Hutton, Feng Xie, David Meyre, Rita E. Morassut, Harry Prapavessis, Lehana Thabane, Stephanie A. Atkinson, Michelle F. Mottola, Keyna Bracken, Eileen K. Hutton, Lehana Thabane, Valerie Taylor, Olive Wahoush, Feng Xie, Stuart M. Phillips, Jennifer Vickers-Manzin, David Meyre, Harry Prapavessis
Retraction Note: WELL.ME - Wellbeing therapy based on real-time personalized mobile architecture, vs. cognitive therapy, to reduce psychological distress and promote healthy lifestyle in cardiovascular disease patients: study protocol for a randomized controlled trial
Angelo Compare, Vassilis Kouloulias, Vontas Apostolos, Wendy Moreno Peña, Enrico Molinari, Enzo Grossi, Efstathopoulos Efstathios, Michele Carenini
Levofloxacin versus placebo for the prevention of tuberculosis disease in child contacts of multidrug-resistant tuberculosis: study protocol for a phase III cluster randomised controlled trial (TB-CHAMP)
James A. Seddon, Anthony J. Garcia-Prats, Susan E. Purchase, Muhammad Osman, Anne-Marie Demers, Graeme Hoddinott, Angela M. Crook, Ellen Owen-Powell, Margaret J. Thomason, Anna Turkova, Diana M. Gibb, Lee Fairlie, Neil Martinson, H. Simon Schaaf, Anneke C. Hesseling
Study of Anti-Malarials in Incomplete Lupus Erythematosus (SMILE): study protocol for a randomized controlled trial
Nancy J. Olsen, Judith A. James, Cristina Arriens, Mariko L. Ishimori, Daniel J. Wallace, Diane L. Kamen, Benjamin F. Chong, Duanping Liao, Vernon M. Chinchilli, David R. Karp
Mechanical suppression of osteolytic bone metastases in advanced breast cancer patients: a randomised controlled study protocol evaluating safety, feasibility and preliminary efficacy of exercise as a targeted medicine
Nicolas H. Hart, Daniel A. Galvão, Christobel Saunders, Dennis R. Taaffe, Kynan T. Feeney, Nigel A. Spry, Daphne Tsoi, Hilary Martin, Raphael Chee, Tim Clay, Andrew D. Redfern, Robert U. Newton
Efficacy of granulocyte colony stimulating factor in patients with severe alcoholic hepatitis with partial or null response to steroid (GRACIAH trial): study protocol for a randomized controlled trial
Yuri Cho, Youn Su Park, Hwi Young Kim, Won Kim, Heon Ju Lee, Dong Joon Kim
Implementation of evidence-based practice for benign paroxysmal positional vertigo: DIZZTINCT– A study protocol for an exploratory stepped-wedge randomized trial
William J. Meurer, Kathryn E. Beck, Brigid Rowell, Devin Brown, Alexander Tsodikov, Angela Fagerlin, Steven A. Telian, Laura Damschroder, Lawrence C. An, Lewis B. Morgenstern, Misty Ujhely, Laura Loudermilk, Sandeep Vijan, Kevin A. Kerber
Guiding intensive care physicians’ communication and behavior towards bereaved relatives: study protocol for a cluster randomized controlled trial (COSMIC-EOL)
Nancy Kentish-Barnes, Sylvie Chevret, Elie Azoulay
Optimising informed consent for participants in a randomised controlled trial in rural Uganda: a comparative prospective cohort mixed-methods study
J. Ditai, J. Kanyago, M. R. Nambozo, N. M. Odeke, J. Abeso, J. Dusabe-Richards, P. Olupot-Olupot, E. D. Carrol, A. Medina-Lara, M. Gladstone, J. Storr, B. Faragher, A. D. Weeks
Efficacy and mechanisms of combined aerobic exercise and cognitive training in mild cognitive impairment: study protocol of the ACT trial
Fang Yu, Feng Vankee Lin, Dereck L. Salisbury, Krupa N. Shah, Lisa Chow, David Vock, Nathaniel W. Nelson, Anton P. Porsteinsson, Clifford Jack Jr.
Early father-infant skin-to-skin contact and its effect on the neurodevelopmental outcomes of moderately preterm infants in China: study protocol for a randomized controlled trial
Qingqi Deng, Qiufang Li, Hua Wang, Huilian Sun, Xinfen Xu
Correction to: Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial
Luciana G. Langella, Paula F. C. Silva, Larissa Costa-Santos, Marcela L. L. Gonçalves, Lara J. Motta, Alessandro M. Deana, Kristianne P. S. Fernandes, Raquel A. Mesquita-Ferrari, Sandra Kalil Bussadori
Correction to: Assessing dengue transmission risk and a vector control intervention using entomological and immunological indices in Thailand: study protocol for a cluster-randomized controlled trial
Hans J. Overgaard, Chamsai Pientong, Kesorn Thaewnongiew, Michael J. Bangs, Tipaya Ekalaksananan, Sirinart Aromseree, Thipruethai Phanitchat, Supranee Phanthanawiboon, Benedicte Fustec, Vincent Corbel, Dominique Cerqueira, Neal Alexander
Challenges recruiting to a proof-of-concept pharmaceutical trial for a rare disease: the trigeminal neuralgia experience
Joanna M. Zakrzewska, Joanne Palmer, Lars Bendtsen, Giulia Di Stefano, Dominik A. Ettlin, Stine Maarbjerg, Mark Obermann, Valerie Morisset, Deb Steiner, Simon Tate, Giorgio Cruccu
Stopping or maintaining oral anticoagulation in patients undergoing photoselective vaporization of the prostate (SOAP) surgery for benign prostate obstruction: study protocol for a multicentre randomized controlled trial
Hélène Charbonneau, Marie Pasquié, Benoit Peyronnet, Aurélien Descazeaud, Nicolas Barry-Delongchamps, Emmanuel Della Negra, Romain Mathieu, Gilles Karsenty, Jean-Alexandre Long, Charles Ballereau, Abdel-Rahmène Azzouzi, Benjamin Pradère, Franck Bruyère, Georges Fournier, Souhil Lebdai, Jehanne Calves, Luc Corbel, Sébastien Vincendeau, Gaelle Fiard, Caroline Thuillier, Jean-Luc Descotes, Pierre Colin, Thibaut Culty, Audrey Hesbois, Valerie Fuzier, Nicolas Savy, Atul Pathak, Pierre Albaladejo, Charles Marc Samama, Felipe Guerrero, Vincent Misraï
Treatment effectiveness of a mindfulness-based inpatient group psychotherapy in adolescent substance use disorder - study protocol for a randomized controlled trial
Christiane Baldus, Laura Mokros, Anne Daubmann, Nicolas Arnaud, Martin Holtmann, Rainer Thomasius, Tanja Legenbauer
Zopiclone versus placebo for short-term treatment of insomnia in patients with advanced cancer: study protocol for a double-blind, randomized, placebo-controlled, clinical multicenter trial
Gunnhild Jakobsen, Morten Engstrøm, Ørnulf Paulsen, Karin Sjue, Sunil X. Raj, Morten Thronæs, Marianne Jensen Hjermstad, Stein Kaasa, Peter Fayers, Pål Klepstad
Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol
Karoline Kragelund Nielsen, Sharleen O’Reilly, Nancy Wu, Kaberi Dasgupta, Helle Terkildsen Maindal
Using mobile phone technology to treat alcohol use disorder: study protocol for a randomized controlled trial
Anna-Karin Danielsson, Andreas Lundin, Sven Andréasson
Conditional economic incentives and motivational interviewing to improve adolescents’ retention in HIV care and adherence to antiretroviral therapy in Southeast Nigeria: study protocol for a cluster randomised trial
Obinna Ikechukwu Ekwunife, Maureen Ugonwa Anetoh, Stephen Okorafor Kalu, Prince Udegbulam Ele, George Uchenna Eleje
Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the Emergency Department with palpitations and pre-syncope - the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial
Matthew J. Reed, Neil R. Grubb, Christopher C. Lang, Rachel O’Brien, Kirsty Simpson, Mia Padarenga, Alison Grant, Sharon Tuck
Tranexamic acid for the prevention of postpartum bleeding in women with anaemia: study protocol for an international, randomised, double-blind, placebo-controlled trial
Katharine Ker, Ian Roberts, Rizwana Chaudhri, Bukola Fawole, Danielle Beaumont, Eni Balogun, Danielle Prowse, Tracey Pepple, Kiran Javaid, Aasia Kayani, Sabaratnam Arulkumaran, Imelda Bates, Haleema Shakur-Still
The effects of an acute bout of exercise on neural activity in alcohol and cocaine craving: study protocol for a randomised controlled trial
Flora Colledge, Sebastian Ludyga, Manuel Mücke, Uwe Pühse, Markus Gerber
Knowledge translation in child welfare—improving educational outcomes for children at risk: study protocol for a hybrid randomized controlled pragmatic trial
Thomas Engell, Ingvild Barbara Follestad, Anne Andersen, Kristine Amlund Hagen
Comparison of the efficacy and safety of tocilizumab for colchicine-resistant or colchicine-intolerant familial Mediterranean fever: study protocol for an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled trial
Tomohiro Koga, Shuntaro Sato, Junya Miyamoto, Naoko Hagimori, Yurika Kawazoe, Kumiko Arinaga, Chizu Fukushima, Hiroshi Yamamoto, Atsushi Kawakami