Ausgabe 1/2019
Inhalt (788 Artikel)
The bowel preparation for magnetic resonance enterography in patients with Crohn’s disease: study protocol for a randomized controlled trial
Min Dai, Ting Zhang, Qianqian Li, Bota Cui, Liyuan Xiang, Xiao Ding, Rong Rong, Jianling Bai, Jianguo Zhu, Faming Zhang
Preventing falls among older fallers: study protocol for a two-phase pilot study of the multicomponent LIVE LiFE program
Marianne Granbom, Lindy Clemson, Laken Roberts, Melissa D. Hladek, Safiyyah M. Okoye, Minhui Liu, Cynthia Felix, David L. Roth, Laura N. Gitlin, Sarah Szanton
Chinese herbal medicine for the treatment of cough variant asthma: a study protocol for a double-blind randomized controlled trial
Rong-rong Fan, Ze-huai Wen, Da-wei Wang, Rong-yuan Yang, Ai-hua Ou, Lian-shun Jin, Zhong-de Zhang, Yun-tao Liu
Intramuscular oxytocin versus oxytocin/ergometrine versus carbetocin for prevention of primary postpartum haemorrhage after vaginal birth: study protocol for a randomised controlled trial (the IMox study)
Helen van der Nelson, Stephen O’Brien, Erik Lenguerrand, Elsa Marques, Mary Alvarez, Michelle Mayer, Sara Burnard, Dimitrios Siassakos, Timothy Draycott
Effect of chiropractic manipulative therapy on reaction time in special operations forces military personnel: a randomized controlled trial
James W. DeVocht, Robert Vining, Dean L. Smith, Cynthia Long, Thomas Jones, Christine Goertz
Effect and feasibility of non-linear periodized resistance training in people with COPD: study protocol for a randomized controlled trial
Erik Frykholm, Peter Klijn, Didier Saey, Hieronymus W. H. van Hees, Per Stål, Thomas Sandström, Ann Sörlin, François Maltais, André Nyberg
Effectiveness of a short video-based educational intervention on factors related to clinical trial participation in adolescents and young adults: a pre-test/post-test design
Joan E. Cowdery, James H. Powell, Yolanda A. Fleming, Devin L. Brown
Local effects of acupuncture on the median and ulnar nerves in patients with carpal tunnel syndrome: a pilot mechanistic study protocol
Alexandra Dimitrova, Charles Murchison, Barry Oken
Metabolic follow-up at one year and beyond of women with gestational diabetes treated with insulin and/or oral hypoglycaemic agents: study protocol for the identification of a core outcomes set using a Delphi survey
Delia Bogdanet, Aoife Egan, Narjes Fhelelboom, Linda Biesty, Shakila Thangaratinam, Eugene Dempsey, Caroline Crowther, Declan Devane, Fidelma Dunne
Hysterectomy and opportunistic salpingectomy (HOPPSA): study protocol for a register-based randomized controlled trial
Annika Idahl, Anna Darelius, Karin Sundfeldt, Mathias Pålsson, Annika Strandell
Muslim Communities Learning About Second-hand Smoke in Bangladesh (MCLASS II): study protocol for a cluster randomised controlled trial of a community-based smoke-free homes intervention, with or without Indoor Air Quality feedback
Noreen Mdege, Caroline Fairhurst, Tarana Ferdous, Catherine Hewitt, Rumana Huque, Cath Jackson, Ian Kellar, Steve Parrott, Sean Semple, Aziz Sheikh, Shilpi Swami, Kamran Siddiqi
Involving people living with dementia in research: an accessible modified Delphi survey for core outcome set development
Hazel Morbey, Andrew J. E. Harding, Caroline Swarbrick, Faraz Ahmed, Ruth Elvish, John Keady, Paula R. Williamson, Siobhan T. Reilly
Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric thermal burn injuries: study protocol for a randomised controlled trial
Maleea D. Holbert, Bronwyn R. Griffin, Steven M. McPhail, Robert S. Ware, Kelly Foster, Demi C. Bertoni, Roy M. Kimble
A core outcome set for clinical trials of Chinese medicine for hyperlipidemia: a study protocol for a systematic review and a Delphi survey
Geng Li, Li Zhou, Wenwei Ouyang, Meiling Xuan, Liming Lu, Xiaoyan Li, Zehuai Wen, Xiankun Chen
Effects of robot-assisted gait training in patients with Parkinson’s disease: study protocol for a randomized controlled trial
Min-Gu Kang, Seo Jung Yun, Hyun Iee Shin, Eunkyung Kim, Hyun Haeng Lee, Byung-Mo Oh, Han Gil Seo
Evaluating Modular Approach to Therapy for Children with Anxiety, Depression, Trauma and Conduct Problems (MATCH-ADCT) in Norwegian child and adolescent outpatient clinics: Study protocol for a randomized controlled trial
Kristine Amlund Hagen, Asgeir Røyrhus Olseth, Hanne Laland, Kristian Rognstad, Anett Apeland, Elisabeth Askeland, Knut Taraldsen, Bernadette Christensen, John Kjøbli, Ana M. Ugueto, Sarah Kate Bearman, John Weisz
Correction to: 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
Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training
Nicole Müller, Kathrin M. Gschwendtner, Sarah Dwinger, Corinna Bergelt, Wolfgang Eich, Martin Härter, Christiane Bieber
Organising Support for Carers of Stroke Survivors (OSCARSS): study protocol for a cluster randomised controlled trial, including health economic analysis
Emma Patchwood, Katy Rothwell, Sarah Rhodes, Evridiki Batistatou, Kate Woodward-Nutt, Yiu-Shing Lau, Gunn Grande, Gail Ewing, Audrey Bowen
Comparing the effects of self-selected music versus predetermined music on patient anxiety prior to gynaecological surgery: a study protocol for a randomised controlled trial
Tiphaine Petot, Nicolas Bouscaren, Olivier Maillard, Laetitia Huiart, Malik Boukerrou, Danielle Reynaud
Longitudinal multi-centre brain imaging studies: guidelines and practical tips for accurate and reproducible imaging endpoints and data sharing
Stewart J. Wiseman, Rozanna Meijboom, Maria del C. Valdés Hernández, Cyril Pernet, Eleni Sakka, Dominic Job, Adam D. Waldman, Joanna M. Wardlaw
Effect of ultrasound-guided lumbar plexus block on emergence agitation in children undergoing hip surgery: study protocol for a randomized controlled trial
Hui Zhang, Qing Fan, Junfeng Zhang, Bin Wu, Xiaofeng Wang, Yu Zhang, Aizhong Wang
Single dose of intravenous ferric carboxymaltose infusion versus multiple fractionated doses of intravenous iron sucrose in the treatment of postoperative anaemia in colorectal cancer patients: study protocol for a randomised controlled trial
María Jesús Laso-Morales, Roser Vives, Andrea Vallejo-Tarrat, Novella Caló, Anna Valle-Beltran, Caridad Pontes
Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial
Termeh Feinberg, L. Susan Wieland, Larry E. Miller, Kashif Munir, Toni I. Pollin, Alan R. Shuldiner, Steve Amoils, Lisa Gallagher, Mary Bahr-Robertson, Christopher R. D’Adamo
Evaluation of an intensive education program on the treatment of tobacco-use disorder for pharmacists: a study protocol for a randomized controlled trial
Maguy Saffouh El Hajj, Ahmed Awaisu, Nadir Kheir, Mohamad Haniki Nik Mohamed, Rula Shami Haddad, Rana Ahmed Saleh, Noora Mohammed Alhamad, Ahmad Mohd Almulla, Ziyad R. Mahfoud
Effect of cognitive training on episodic memory retrieval in amnestic mild cognitive impairment patients: study protocol for a clinical randomized controlled trial
Kan Zhang, Junyang Wang, Guoping Peng, Ping Liu, Fangping He, Zude Zhu, Benyan Luo
Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N-acetylcysteine for paracetamol overdose—the PP100–01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial
Ruaridh Buchan, Thomas Caparrotta, Michael Eddleston, Emma E. Morrison, Matthew Reed, Robert J. Lee, Garry Milne, Lynsey Milne, Katherine Oatey, Phillip Rayson, Michelle Steven, Christopher J. Weir, Polly Black, Caroline Blackstock, Rachel O’Brien, Bernadette Gallagher, Julia Grahamslaw, Adam Lloyd, Allan Macraild, Megan McGrath, Mary Morrissey, Emma Ward, Liz Hasseld, Mia Paderanga, Miranda Odam, Dennis Henriksen, Marie Bengtson, James W. Dear, Wilna Oosthuyzen, James Dear
Comparison of dexmedetomidine vs. remifentanil combined with sevoflurane during radiofrequency ablation of hepatocellular carcinoma: a randomized controlled trial
Jingru Pan, Xianlong Li, Ye He, Chaojun Jian, Hui-xin Chen, Ziqing Hei, Shaoli Zhou
The Back2School modular cognitive behavioral intervention for youths with problematic school absenteeism: study protocol for a randomized controlled trial
Mikael Thastum, Daniel Bach Johnsen, Wendy K. Silverman, Pia Jeppesen, David A. Heyne, Johanne Jeppesen Lomholt
Sciatic nerve block or not for outpatient total knee arthroplasty? Study protocol for a randomized controlled trial
Laurie Tran, Melissa Barthelemy, Pascal Boileau, Marc Raucoules-Aime, Michel Carles, Christophe Trojani
Comparison of the clinical performance of the flexible laryngeal mask airway in pediatric patients under general anesthesia with or without a muscle relaxant: study protocol for a randomized controlled trial
Sung Hye Byun, Soo Jin Kim, Eugene Kim
The value of Eye Movement Desensitization Reprocessing in the treatment of tinnitus: study protocol for a randomized controlled trial
Tine Luyten, Paul Van de Heyning, Laure Jacquemin, Nancy Van Looveren, Frank Declau, Erik Fransen, Annick Gilles
Scopolamine augmentation of a newly initiated escitalopram treatment for major depressive disorder: study protocol for a randomized controlled trial
Jingjing Zhou, Weiwei Wang, Jian Yang, Xuequan Zhu, Lei Feng, Le Xiao, Gang Wang
Intravenous administration of adenosine triphosphate and phosphocreatine combined with fluoxetine in major depressive disorder: protocol for a randomized, double-blind, placebo-controlled pilot study
Yiyi Chen, Xiaomin Cao, Wensi Zang, Shanyong Tan, Chun-quan Ou, Xiaoyan Shen, Tianming Gao, Lianxu Zhao
Study protocol: developing, disseminating, and implementing a core outcome set for selective fetal growth restriction in monochorionic twin pregnancies
Asma Khalil, James M. N. Duffy, Helen Perry, Wessel Ganzevoort, Keith Reed, Ahmet A. Baschat, Jan Deprest, Eduardo Gratacos, Kurt Hecher, Liesbeth Lewi, Enrico Lopriore, Dick Oepkes, Aris Papageorghiou, Sanne J. Gordijn
The safety, efficacy and cost-effectiveness of the Maxm Skate, a lower limb rehabilitation device for use following total knee arthroplasty: study protocol for a randomised controlled trial
Matthew G. Liptak, Annika Theodoulou, Billingsley Kaambwa, Steve Saunders, Scott W. Hinrichs, Richard J. Woodman, Jeganath Krishnan
Clazakizumab in late antibody-mediated rejection: study protocol of a randomized controlled pilot trial
Farsad Eskandary, Michael Dürr, Klemens Budde, Konstantin Doberer, Roman Reindl-Schwaighofer, Johannes Waiser, Markus Wahrmann, Heinz Regele, Andreas Spittler, Nils Lachmann, Christa Firbas, Jakob Mühlbacher, Gregor Bond, Philipp F. Halloran, Edward Chong, Bernd Jilma, Georg A. Böhmig
Effectiveness of a telephone-based intervention for smoking cessation in patients with severe mental disorders: study protocol for a randomized controlled trial
Montse Ballbè, Cristina Martínez, Ariadna Feliu, Núria Torres, Gemma Nieva, Cristina Pinet, Antònia Raich, Sílvia Mondon, Pablo Barrio, Rosa Hernández-Ribas, Jordi Vicens, Sílvia Costa, Jordi Vilaplana, Laura Alaustre, Eva Vilalta, Roser Blanch, Susana Subirà, Eugeni Bruguera, Josep Maria Suelves, Joseph Guydish, Esteve Fernández
Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial
Senthil Packiasabapathy, Ammu T. Susheela, Ariel Mueller, Melissa Patxot, Doris-Vanessa Gasangwa, Brian O’Gara, Shahzad Shaefi, Edward R. Marcantonio, Gloria Y. Yeh, Balachundhar Subramaniam
Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial
Yi Liang, Guanai Bao, Liyan Gong, Jie Zhou, Xiangming Kong, Ran Ran, Xiaomei Shao, Yongliang Jiang, Weiping Zhang, Boyi Liu, Junying Du, Junfan Fang, Na Nie, Conghua Ji, Jianqiao Fang
Effects of home-based prescribed pulmonary exercise by patients with chronic obstructive pulmonary disease: study protocol for a randomized controlled trial
Xiaodan Liu, Peijun Li, Lu Xiao, Yufan Lu, Ning Li, Zhengrong Wang, Hongxia Duan, Jian Li, Weibing Wu
Detailed statistical analysis plan for the Dutch STRIDER (Sildenafil TheRapy In Dismal prognosis Early-onset fetal growth Restriction) randomised clinical trial on sildenafil versus placebo for pregnant women with severe early onset fetal growth restriction
Anouk Pels, Janus C. Jakobsen, Wessel Ganzevoort, Christiana A. Naaktgeboren, Wes Onland, Aleid G. van Wassenaer-Leemhuis, Christian Gluud
The correlation between baseline score and post-intervention score, and its implications for statistical analysis
Lei Clifton, David A. Clifton
Vagus nerve stimulation for pediatric patients with intractable epilepsy between 3 and 6 years of age: study protocol for a double-blind, randomized control trial
Taoyun Ji, Zhao Yang, Qingzhu Liu, Jianxiang Liao, Fei Yin, Yanhui Chen, Liping Zou, Baomin Li, Yuxing Gao, Xiaomei Shu, Shaoping Huang, Feng Gao, Jianmin Liang, Su Fang Lin, Jing Peng, Shiwei Song, Jing Wang, Chao Che, Wenxiu Sun, Maoqiang Tian, Lin Yang, Yi Hua, Yunpeng Hao, Lixin Cai, Luming Li, Yuwu Jiang
Process evaluation of the context, reach and recruitment of participants and delivery of dementia-specific case conferences (WELCOME-IdA) in nursing homes (FallDem): a mixed-methods study
Daniela Holle, Rene Müller-Widmer, Sven Reuther, Ute Rosier-Segschneider, Rabea Graf, Martina Roes, Margareta Halek
Traditional Chinese medicine (TCM) collaborative care for patients with axial spondyloarthritis (AcuSpA): protocol for a pragmatic randomized controlled trial
Yu Heng Kwan, Warren Fong, Xiang Ling Ang, Chuen Seng Tan, Bee Choo Tai, Youyi Huang, Marcel Bilger, Jie Kie Phang, Hui Chin Tan, Jia Ven Lee, Limin Sun, Choy Tip Tan, Bao Qiang Dong, Hwee Ling Koh, Ying Ying Leung, Nai Lee Lui, Siaw Ing Yeo, Swee Cheng Ng, Kok Yong Fong, Julian Thumboo, Truls Østbye
Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial
María José Jaén-Moreno, Nuria Feu, Justa Redondo-Écija, Francisco Javier Montiel, Cristina Gómez, Gloria I. del Pozo, Jose Ángel Alcalá, Luis Gutiérrez-Rojas, Vicente Balanzá-Martinez, Geli Marie Chauca, Laura Carrión, Maria Isabel Osuna, María Dolores Sánchez, Inmaculada Caro, Miriam Ayora, Francisca Valdivia, María Soledad López, Jose Manuel Poyato, Fernando Sarramea
Correction to: 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
Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial
Thomas G. de Leeuw, Laura Mangiarini, Rebecca Lundin, Florentia Kaguelidou, Tjitske van der Zanden, Oscar Della Pasqua, Dick Tibboel, Adriana Ceci, Saskia N. de Wildt, Donjeta Bali, Alketa Hoxha-Qosja, Ermira Kola, Juliette Andrieu-Galien, Daniel Annequin, Romy Blanchet, Isabelle Desguerre, Elisabeth Fournier-Charrière, Florentia Kaguelidou, Barbara Tourniaire, Chantal Wood, Antje Neubert, Regina Trollmann, Stefan Wimmer, Eleana Garini, Panagoula Mammi, Marcello Allegretti, Ornella Bellagamba, Franca Benini, Donato Bonifazi, Daniela Caprino, Adriana Ceci, Sabrina Congedi, Francesco Craig, Sandro Dallorso, Antuan Divisic, Mariagrazia Felisi, Marco Gentile, Andrea De Giacomo, Rebecca Lundin, Luca Manfredini, Laura Mangiarini, Emilia Matera, Lucia Margari, Alessandro Mazza, Virgilio Pace, Chiara Di Pede, Maria Giuseppina Petruzzelli, Pieradelchi Ruffini, Luigina Tagliavacca, Maria Traverso, Anna Szumowska, Tom de Leeuw, Maarten Mensink, Lonneke Staals, Dick Tibboel, Saskia N. de Wildt, Tjitske van der Zanden, Dmytro Delva, Andrii Loboda, Katerina Savinova, Grygorii Ursol, Helen Neary, Oscar Della Pasqua, Paul Healy
Effect of preconceptional DHEA treatment on in vitro fertilization outcome in poor ovarian respond women: study protocol for a randomized controlled trial
Wei Wang, Hong Liu, Jing Li, Daimin Wei, Jiangtao Zhang, Jianfeng Wang, Jinlong Ma, Yuhua Shi, Zi-Jiang Chen
Comparing the placement of a left-sided double-lumen tube via fiberoptic bronchoscopy guidance versus conventional intubation using a Macintosh laryngoscope, to reduce the incidence of malpositioning: study protocol for a randomized controlled pilot trial
Taeha Ryu, Eugene Kim, Jong Hae Kim, Seong Jun Woo, Woon Seok Roh, Sung Hye Byun
Nurse-led, telephone-based secondary preventive follow-up benefits stroke/TIA patients with low education: a randomized controlled trial sub-study
Anna-Lotta Irewall, Joachim Ögren, Lisa Bergström, Katarina Laurell, Lars Söderström, Thomas Mooe
Efficacy and cost-effectiveness of two online interventions for children and adolescents at risk for depression (E.motion trial): study protocol for a randomized controlled trial within the ProHEAD consortium
Sabrina Baldofski, Elisabeth Kohls, Stephanie Bauer, Katja Becker, Sally Bilic, Heike Eschenbeck, Michael Kaess, Markus Moessner, Hans Joachim Salize, Silke Diestelkamp, Elke Voß, Christine Rummel-Kluge, Michael Kaess, Stephanie Bauer, Rainer Thomasius, Christine Rummel-Kluge, Heike Eschenbeck, Hans-Joachim Salize, Katja Becker, Katja Bertsch, Sally Bilic, Romuald Brunner, Johannes Feldhege, Christina Gallinat, Sabine C. Herpertz, Julian Koenig, Sophia Lustig, Markus Moessner, Fikret Özer, Peter Parzer, Franz Resch, Sabrina Ritter, Jens Spinner, Silke Diestelkamp, Kristina Wille, Sabrina Baldofski, Elisabeth Kohls, Lina-Jolien Peter, Vera Gillé, Hanna Hofmann, Laya Lehner, Elke Voß, Jens Pfeiffer, Alisa Samel
PREDOMOS study, impact of a social intervention program for socially isolated elderly cancer patients: update to the study protocol for a randomized controlled trial
Anne-Laure Couderc, Emilie Nouguerède, Karine Baumstarck, Sandrine Loubière, Hervé Le Caer, Olivier Guillem, Frédérique Rousseau, Laurent Greillier, Emmanuelle Norguet-Monnereau, Maud Cecile, Rabia Boulahssass, Françoise Le Caer, Sandrine Tournier, Chantal Butaud, Pierre Guillet, Sophie Nahon, Sylvie Kirscher, Nadine Diaz, Claire Morando, Patrick Villani, Pascal Auquier, Aurélie Daumas
BIOLAP: biological versus synthetic mesh in laparo-endoscopic inguinal hernia repair: study protocol for a randomized, multicenter, self-controlled clinical trial
C. S. Seefeldt, J. S. Meyer, J. Knievel, A. Rieger, R. Geißen, R. Lefering, M. M. Heiss
Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial
Koh-Woon Kim, Kyungmo Park, Hi-Joon Park, Geon-Ho Jahng, Dae-Jean Jo, Jae-Heung Cho, Eun-Mo Song, Woo-Chul Shin, Ye-Ji Yoon, Soo-Jeon Kim, Seulgi Eun, Mi-Yeon Song
Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial
Myungsun Lee, Jeongha Mok, Deog Kyeom Kim, Tae Sun Shim, Won-Jung Koh, Doosoo Jeon, Taehoon Lee, Seung Heon Lee, Ju Sang Kim, Jae Seuk Park, Ji Yeon Lee, Song Yee Kim, Jae Ho Lee, Kyung-Wook Jo, Byung Woo Jhun, Young Ae Kang, Joong Hyun Ahn, Chang-Ki Kim, Soyoun Shin, Taeksun Song, Sung Jae Shin, Young Ran Kim, Heejung Ahn, Seokyung Hahn, Ho Jeong Won, Ji Yeon Jang, Sang Nae Cho, Jae-Joon Yim
Cerebral mechanism of celecoxib for treating knee pain: study protocol for a randomized controlled parallel trial
Chenjian Tang, Xiaohui Dong, Wenhua He, Shirui Cheng, Yang Chen, Yong Huang, Bao Yin, Yu Sheng, Jun Zhou, Xiaoli Wu, Fang Zeng, Zhengjie Li, Fanrong Liang
Efficacy of tuina in patients with chronic neck pain: study protocol for a randomized controlled trial
Zhiwei Wu, Lingjun Kong, Qingguang Zhu, Pengfei Song, Min Fang, Wuquan Sun, Hao Zhang, Yanbin Cheng, Shanda Xu, Guangxin Guo, Xin Zhou, Zhizhen Lv
Temporary transvenous diaphragm pacing vs. standard of care for weaning from mechanical ventilation: study protocol for a randomized trial
Douglas Evans, Deborah Shure, Linda Clark, Gerard J. Criner, Martin Dres, Marcelo Gama de Abreu, Franco Laghi, David McDonagh, Basil Petrof, Teresa Nelson, Thomas Similowski
Efficacy and safety of exogenous ketone bodies for preventive treatment of migraine: A study protocol for a single-centred, randomised, placebo-controlled, double-blind crossover trial
Elena Gross, Niveditha Putananickal, Anna-Lena Orsini, Simone Schmidt, Deborah R. Vogt, Sven Cichon, Peter Sandor, Dirk Fischer
A phase III wait-listed randomised controlled trial of novel targeted inter-professional clinical education intervention to improve cancer patients’ reported pain outcomes (The Cancer Pain Assessment (CPAS) Trial): study protocol
Jane L. Phillips, Nicole Heneka, Melanie Lovell, Lawrence Lam, Patricia Davidson, Frances Boyle, Nikki McCaffrey, Sally Fielding, Tim Shaw
Evaluating the efficacy of Seattle-PAP for the respiratory support of premature neonates: study protocol for a randomized controlled trial
Carl H. Backes, Jennifer L. Notestine, Jane M. Lamp, Jeanne C. Balough, Allison M. Notestine, Crystal M. Alfred, Juli M. Kern, Michael R. Stenger, Brian K. Rivera, Mohannad Moallem, Randy R. Miller, Apurwa Naik, Jennifer N. Cooper, Christopher R. Howard, Stephen E. Welty, Noah H. Hillman, John A. F. Zupancic, Larissa I. Stanberry, Thomas N. Hansen, Charles V. Smith
School-based mental health promotion in children and adolescents with StresSOS using online or face-to-face interventions: study protocol for a randomized controlled trial within the ProHEAD Consortium
Heike Eschenbeck, Laya Lehner, Hanna Hofmann, Stephanie Bauer, Katja Becker, Silke Diestelkamp, Michael Kaess, Markus Moessner, Christine Rummel-Kluge, Hans-Joachim Salize, Michael Kaess, Stephanie Bauer, Rainer Thomasius, Christine Rummel-Kluge, Heike Eschenbeck, Hans-Joachim Salize, Katja Becker, Katja Bertsch, Sally Bilic, Romuald Brunner, Johannes Feldhege, Christina Gallinat, Sabine C. Herpertz, Julian Koenig, Sophia Lustig, Markus Moessner, Fikret Özer, Peter Parzer, Franz Resch, Sabrina Ritter, Jens Spinner, Silke Diestelkamp, Kristina Wille, Sabrina Baldofski, Elisabeth Kohls, Lina-Jolien Peter, Vera Gillé, Hanna Hofmann, Laya Lehner, Elke Voss, Jens Pfeiffer, Alisa Samel
Efficacy of acupuncture versus sham acupuncture for postprandial distress syndrome: study protocol for a randomized controlled trial
Ya-Quan Hou, Xin Zhang, Jian-Feng Tu, Yang Zheng, Jing-Wen Yang, Mirim Kim, Hui Hu, Li-Qiong Wang, Jing-Jie Zhao, Wei Zhou, Jun Wang, Xuan Zou, Yu Wang, Guang-Xia Shi, Cun-Zhi Liu
Chinese herbal medicine bi min fang for allergic rhinitis: protocol for a double-blind, double-dummy, randomized controlled trial
Qiulan Luo, Shiqing Zhou, Xiaoshan Li, Qubo Chen, Wenmin Lin, Liming Lu, Hua Li, Caifeng Chen, Wenyong Chen, Yunying Li
Enteral Nutrition Tolerance And REspiratory Support (ENTARES) Study in preterm infants: study protocol for a randomized controlled trial
Francesco Cresi, Elena Maggiora, Silvia Maria Borgione, Elena Spada, Alessandra Coscia, Enrico Bertino, Fabio Meneghin, Luigi Tommaso Corvaglia, Maria Luisa Ventura, Gianluca Lista, Fabio Mosca, Anna Orsi, Domenica Mercadante, Stefano Martinelli, Laura Ilardi, Alice Proto, Sara Gatto, Arianna Aceti, Fabrizio Sandri, Roksana Chakrokh, Nicola Laforgia, Antonio Di Mauro, Maria E. Baldassarre, Antonio Del Vecchio, Flavia Petrillo, Maria P. Spalierno, Francesco Raimondi, Letizia Capasso, Marta Palma, Daniele Farina, Maria F. Campagnoli, Tatiana Boetti, Federica Logrippo, Massimo Agosti, Laura Morlacchi, Simona Perniciaro, Carlo Dani, Serena Elia, Giovanni Vento, Luca Maggio, Mauro Stronati, Elisa Civardi, Grappone Lidia, Borrelli Angela
Introducing the new CONSORT extension for stepped-wedge cluster randomised trials
Karla Hemming, Monica Taljaard, Jeremy Grimshaw
Integral movement therapy versus local movement therapy approach in patients with idiopathic chronic low-back pain: study protocol for a randomized controlled trial
Suzana Pustivšek, Nejc Šarabon
Low-dose aspirin and burr-hole drainage of chronic subdural hematoma: study protocol for a randomized controlled study
Maria Kamenova, Christian Mueller, Michael Coslovsky, Raphael Guzman, Luigi Mariani, Jehuda Soleman
Patient safety, cost-effectiveness, and quality of life: reduction of delirium risk and postoperative cognitive dysfunction after elective procedures in older adults—study protocol for a stepped-wedge cluster randomized trial (PAWEL Study)
Alba Sánchez, Christine Thomas, Friederike Deeken, Sören Wagner, Stefan Klöppel, Felix Kentischer, Christine A. F. von Arnim, Michael Denkinger, Lars O. Conzelmann, Janine Biermann-Stallwitz, Stefanie Joos, Heidrun Sturm, Brigitte Metz, Ramona Auer, Yoanna Skrobik, Gerhard W. Eschweiler, Michael A. Rapp, Florian Metzger, Andreas Straub, Tobias Krüger, Felix Bausenhart, Petra Renz, Andreas Walther, Carola Bruns, Juliane Spank, Patricia Sabbah, Andreas Häusler, Bernd Förstner, Susanne Schulze, Christoph Maurer, Markus Martin, Bernhard Heimbach, Sebastian Voigt-Radloff, Heiko Reichel, Andreas Liebold, Olivia Küster, Simone Brefka, Stephan Kirschner, Nina Stober, Uwe Mehlhorn, Jürgen Wasem, Anja Neumann
Editorial Promoting Help-seeking using E-Technology for ADolescents: The ProHEAD consortium
Michael Kaess, Stephanie Bauer
Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium
Silke Diestelkamp, Lutz Wartberg, Michael Kaess, Stephanie Bauer, Christine Rummel-Kluge, Katja Becker, Heike Eschenbeck, Hans-Joachim Salize, Markus Moessner, Christiane Baldus, Nicolas Arnaud, Rainer Thomasius, Michael Kaess, Stephanie Bauer, Rainer Thomasius, Christine Rummel-Kluge, Heike Eschenbeck, Hans-Joachim Salize, Katja Becker, Katja Bertsch, Sally Bilic, Romuald Brunner, Johannes Feldhege, Christina Gallinat, Sabine C. Herpertz, Julian Koenig, Sophia Lustig, Markus Moessner, Fikret Özer, Peter Parzer, Franz Resch, Sabrina Ritter, Jens Spinner, Silke Diestelkamp, Kristina Wille, Sabrina Baldofski, Elisabeth Kohls, Lina-Jolien Peter, Vera Gillé, Hanna Hofmann, Laya Lehner, Elke Voss, Jens Pfeiffer, Alisa Samel
A self-guided Internet-based intervention for individuals with gambling problems: study protocol for a randomized controlled trial
Lara Bücker, Stefan Westermann, Simone Kühn, Steffen Moritz
Rationale and methods of an Evaluation of the Effectiveness of the Community Paramedicine at Home (CP@home) program for frequent users of emergency medical services in multiple Ontario regions: a study protocol for a randomized controlled trial
Gina Agarwal, Melissa Pirrie, Brent McLeod, Ricardo Angeles, Walter Tavares, Francine Marzanek, Lehana Thabane
Effect of a lifestyle-focused electronic patient support application for improving risk factor management, self-rated health, and prognosis in post-myocardial infarction patients: study protocol for a multi-center randomized controlled trial
Manuel Gonzalez, Ingela Sjölin, Maria Bäck, Halldora Ögmundsdottir Michelsen, Tina Tanha, Camilla Sandberg, Alexandru Schiopu, Margret Leosdottir
Hospital based care at home; study protocol for a mixed epidemiological and randomized controlled trial
Ingebjørg Irgens, Jana M. Hoff, Hilde Sørli, Hanne Haugland, Johan K. Stanghelle, Tiina Rekand
The Evaluation of Vitiligous lesions Repigmentation after the Administration of Atorvastatin calcium salt and Simvastatin-acid sodium salt in patients with active vitiligo (EVRAAS), a pilot study: study protocol for a randomized controlled trial
Anna Niezgoda, Andrzej Winnicki, Tomasz Kosmalski, Bogna Kowaliszyn, Jerzy Krysiński, Rafał Czajkowski
Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial
Jian-Feng Tu, Jing-Wen Yang, Lu-Lu Lin, Tian-Qi Wang, Yu-Zheng Du, Zhi-Shun Liu, Hui Hu, Jing-Jie Zhao, Xiao-Gang Yu, Chun-Sheng Jia, Jun Wang, Tong Wang, Ya-Quan Hou, Xuan Zou, Yu Wang, Jia-Kai Shao, Li-Qiong Wang, Zhang-Sheng Yu, Cun-Zhi Liu
Individualised sensory intervention to improve quality of life in people with dementia and their companions (SENSE-Cog trial): study protocol for a randomised controlled trial
Jemma Regan, Eric Frison, Fidéline Collin, Piers Dawes, Mark Hann, Ines Himmelsbach, Emma Hooper, David Reeves, Zoe Simkin, Chryssoula Thodi, Fan Yang, Iracema Leroi, Harvey Abrams, Nathalie Chaghil-Boissière, Pavlina Charalambous, Fidéline Collin, Fofi Constantinidou, Eric Frison, Camille Gilbert, Mark Hann, Catherine Helmer, Emma Hooper, Francine Jury, Evangelia Kontogianni, Brian Lawlor, Iracema Leroi, Charly Matard, Susana Montecelo, Sarah Marie, Antonios Politis, Otilia Postea, Jemma Regan, David Reeves, David Renaud, Zoe Simkin, Monique Termote, Chryssoula Thodi, Lucas Wolski
Efficacy of motivating short interventions for smokers in primary care (COSMOS trial): study protocol for a cluster-RCT
Thomas Grischott, Oliver Senn, Thomas Rosemann, Anja Frei, Jacques Cornuz, Eva Martin-Diener, Stefan Neuner-Jehle
Why patients decline participation in an intervention to reduce re-hospitalization through patient activation: whom are we missing?
Maria Flink, Carina Brandberg, Mirjam Ekstedt
Triangulating stapling vs functional end-to-end stapling for cervical esophagogastric anastomosis after esophagectomy for thoracic esophageal cancer: study protocol for a randomized controlled trial
Toshiaki Tsuji, Toshiyasu Ojima, Mikihito Nakamori, Masaki Nakamura, Masahiro Katsuda, Keiji Hayata, Junya Kitadani, Shimpei Maruoka, Toshio Shimokawa, Hiroki Yamaue
Comparison of clinical outcomes following percutaneous coronary intervention versus optimal medical therapy based on gray-zone fractional flow reserve in stable angina patients with intermediate coronary artery stenosis (COMFORTABLE prospective study): Study protocol for a multicenter randomized controlled trial
Hironori Kitabata, Takashi Kubo, Yasutsugu Shiono, Kunihiro Shimamura, Yasushi Ino, Takashi Tanimoto, Yasushi Hayashi, Kenichi Komukai, Hiromichi Sougawa, Keizo Kimura, Masahiro Gohda, Toshikazu Hashizume, Masahiro Obana, Kazuisa Maeda, Junichi Yamaguchi, Takashi Akasaka
Planned delivery or expectant management for late preterm pre-eclampsia: study protocol for a randomised controlled trial (PHOENIX trial)
Lucy C. Chappell, Marcus Green, Neil Marlow, Jane Sandall, Rachael Hunter, Stephen Robson, Ursula Bowler, Virginia Chiocchia, Pollyanna Hardy, Edmund Juszczak, Louise Linsell, Anna Placzek, Peter Brocklehurst, Andrew Shennan
Evaluation of the impact of levothyroxine treatment on the psychomotor developmental status of three-year-old children born to mothers with mild thyroid impairment; Tehran Thyroid and pregnancy study: study protocol for a randomized clinical trial
Sima Nazarpour, Fahimeh Ramezani Tehrani, Firoozeh Sajedi, Razieh Bidhendi Yarandi, Fereidoun Azizi
Automated psychological therapy using virtual reality (VR) for patients with persecutory delusions: study protocol for a single-blind parallel-group randomised controlled trial (THRIVE)
Daniel Freeman, Rachel Lister, Felicity Waite, Ly-Mee Yu, Mel Slater, Graham Dunn, David Clark
Comparison of effects between SMR/delta-ratio and beta1/theta-ratio neurofeedback training for older adults with Mild Cognitive Impairment: a protocol for a randomized controlled trial
Fabienne Marlats, Leila Djabelkhir-Jemmi, Eric Azabou, Marouane Boubaya, Sjaak Pouwels, Anne-Sophie Rigaud
Virtual reality gait training versus non-virtual reality gait training for improving participation in subacute stroke survivors: study protocol of the ViRTAS randomized controlled trial
Ilona J. M. de Rooij, Ingrid G. L. van de Port, Johanna M. A. Visser-Meily, Jan-Willem G. Meijer
Evaluation of a blended-learning training concept to train oncology physicians to advise their patients about complementary and integrative medicine (KOKON-KTO): study protocol for a prospective, multi-center, cluster-randomized trial
Stefanie M. Helmer, Alizé A. Rogge, Felix Fischer, Daniel Pach, Markus Horneber, Stephanie Roll, Claudia M. Witt
Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium
Stephanie Bauer, Sally Bilić, Christina Reetz, Fikret Ozer, Katja Becker, Heike Eschenbeck, Michael Kaess, Christine Rummel-Kluge, Hans-Joachim Salize, Silke Diestelkamp, Markus Moessner, Michael Kaess, Stephanie Bauer, Rainer Thomasius, Christine Rummel-Kluge, Heike Eschenbeck, Hans-Joachim Salize, Katja Becker, Katja Bertsch, Sally Bilić, Romuald Brunner, Johannes Feldhege, Christina Gallinat, Sabine C. Herpertz, Julian Koenig, Sophia Lustig, Markus Moessner, Fikret Ozer, Peter Parzer, Franz Resch, Sabrina Ritter, Jens Spinner, Silke Diestelkamp, Kristina Wille, Sabrina Baldofski, Elisabeth Kohls, Lina-Jolien Peter, Vera Gillé, Hanna Hofmann, Laya Lehner, Elke Voss, Jens Pfeiffer, Alisa Samel
Handheld ECG Tracking of in-hOspital Atrial Fibrillation The HECTO-AF trial Clinical Study Protocol
Sara Schukraft, Marco Mancinetti, Daniel Hayoz, Yannick Faucherre, Stéphane Cook, Diego Arroyo, Serban Puricel
Update on the General Practice Optimising Structured Monitoring to Improve Clinical Outcomes in Type 2 Diabetes (GP-OSMOTIC) trial: statistical analysis plan for a multi-centre randomised controlled trial
Sharmala Thuraisingam, Patty Chondros, Max Catchpool, Kim Dalziel, Jo-Anne Manski-Nankervis, Jane Speight, Elizabeth Holmes-Truscott, Ralph Audehm, Jason Chiang, Irene Blackberry, David O’Neal, Kamlesh Khunti, James Best, John Furler
Promoting Help-seeking using E-technology for ADolescents with mental health problems: study protocol for a randomized controlled trial within the ProHEAD Consortium
Michael Kaess, Sabrina Ritter, Sophia Lustig, Stephanie Bauer, Katja Becker, Heike Eschenbeck, Markus Moessner, Christine Rummel-Kluge, Hans-Joachim Salize, Rainer Thomasius, Franz Resch, Julian Koenig, Michael Kaess, Stephanie Bauer, Rainer Thomasius, Christine Rummel-Kluge, Heike Eschenbeck, Hans-Joachim Salize, Katja Becker, Katja Bertsch, Sally Bilic, Romuald Brunner, Johannes Feldhege, Christina Gallinat, Sabine C. Herpertz, Julian Koenig, Sophia Lustig, Markus Moessner, Fikret Özer, Peter Parzer, Franz Resch, Sabrina Ritter, Jens Spinner, Silke Diestelkamp, Kristina Wille, Sabrina Baldofski, Elisabeth Kohls, Lina-Jolien Peter, Vera Gillé, Hanna Hofmann, Laya Lehner, Elke Voss, Jens Pfeiffer, Alisa Samel
Early and comprehensive care bundle in the elderly for acute heart failure in the emergency department: study protocol of the ELISABETH stepped-wedge cluster randomized trial
Yonathan Freund, Judith Gorlicki, Marine Cachanado, Sarah Salhi, Vanessa Lemaître, Tabassome Simon, Alexandre Mebazaa
Parathyroid autotransplantation at a novel site for better evaluation of the grafted gland function: study protocol for a prospective, randomized controlled trial
Qiuxia Cui, Deguang Kong, Zhihua Li, Kun Wang, Dan Zhang, Jianing Tang, Xing Liao, Qianqian Yuan, Yan Gong, Gaosong Wu
Effect of photobiomodulation on the severity of oral mucositis and molecular changes in head and neck cancer patients undergoing radiotherapy: a study protocol for a cost-effectiveness randomized clinical trial
Allisson Filipe Lopes Martins, Túlio Eduardo Nogueira, Marília Oliveira Morais, Angélica Ferreira Oton-Leite, Marize Campos Valadares, Aline Carvalho Batista, Nilceana Maya Aires Freitas, Cláudio Rodrigues Leles, Elismauro Francisco Mendonça
Social cognitive theory-based intervention to promote physical activity among prediabetic rural people: a cluster randomized controlled trial
Tahereh Shamizadeh, Leila Jahangiry, Parvin Sarbakhsh, Koen Ponnet
Sentinel lymph node excision with or without preoperative hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) in melanoma: study protocol for a multicentric randomized controlled trial
Ingo Stoffels, Ken Herrmann, Jan Rekowski, Philipp Jansen, Dirk Schadendorf, Andreas Stang, Joachim Klode
Commentary: On the levels of patient selection in registry-based randomized controlled trials
Florian Lasch, Kristina Weber, Armin Koch
Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients – the study design of the LIBERAL-Trial
Patrick Meybohm, Simone Lindau, Sascha Treskatsch, Roland Francis, Claudia Spies, Markus Velten, Maria Wittmann, Erdem Gueresir, Christian Stoppe, Ana Kowark, Mark Coburn, Sixten Selleng, Marcel Baschin, Gregor Jenichen, Melanie Meersch, Thomas Ermert, Alexander Zarbock, Peter Kranke, Markus Kredel, Antonia Helf, Rita Laufenberg-Feldmann, Marion Ferner, Eva Wittenmeier, Karl-Heinz Gürtler, Peter Kienbaum, Marcel Gama de Abreu, Michael Sander, Michael Bauer, Timo Seyfried, Matthias Gruenewald, Suma Choorapoikayil, Markus M. Mueller, Erhard Seifried, Oana Brosteanu, Holger Bogatsch, Dirk Hasenclever, Kai Zacharowski, David Baron, Oliver Grottke, Aileen Hill, Julia Van Waesberghe, Sebastian Ziemann, Markus Tingart, Julius van Essen, Oliver Spring, Raphael Pirzer, Ulrich Jaschinski, Axel R. Heller, Martin Ertmer, Elke Falk, Philipp Pickerodt, Alexander Schiemann, Katrin Schmidt, Sascha Tafelski, Ralf-Felix Trauzeddel, Carsten Perka, Heide Ehrentraut, Louise Fingehut, Andreas Hopf, Vera Guttenthaler, Claudia Neumann, Isabelle Osberghaus, Patrick Schuss, Anja Winkler, Hendrik Kohlhof, Dieter C. Wirtz, Robert Kalb, Jonas Hinterberg, Maximilian Schäfer, Thea Koch, Florian Piekarski, Linda Tanner, Kira Berg, Carolin Wiedenbeck, Isabell Maushagen, Daniela Zeisset, Christoph Fuellenbach, Sabine Westphal, Sophia Pfeiffer, Andreas Schnitzbauer, Ingo Marzi, Andreas Becker, Shahram Ghanaati, Thomas Schmitz-Rixen, Verena Brixner, Christof Geisen, Eva Herrmann, Fabian Edinger, Christian Koch, Christian Kunzemann, Dominik Leicht, Melanie Markmann, Sophie Ruhrmann, Emanuel Schneck, Dargmar Schulte, Matthias Gründling, Iris Brenig, Manuela Gerber, Kathleen Selleng, Sandra Wodrig, Frank Bloos, Petra Bloos, Anja Haucke, Karina Knuhr-Kohlberg, Steffi Kolanos, Katrin Schwope, Daniel Thomas, Corinna Buchholz, Birte Heller, Jochen Renner, Nina Schulz-Ruhtenberg, Gunnar Elke, Susanne Fischer, Sabine Hofbauer, Peter Straub, Sophie Zimmer, Mira Küllmar, Nadine Rosenow, Christina Massoth, Raphael Weiss, Diane Bitzinger, Karin Pfister, Ines Guzman, Eva-Maria Kranke, Norbert Roewer, Achim Woeckel, Philipp Helmer
Study protocol for a peer-led web-based intervention to promote safe usage of dating applications among young adults: a cluster randomized controlled trial
Stephanie Tsz Hei Lau, Kitty Wai Ying Choi, Julie Chen, William Pak-hing Mak, Ho Kong Christopher Au Yeung, Joseph Tucker, William Chi-Wai Wong
Converting habits of antibiotic use for respiratory tract infections in German primary care – study protocol of the cluster-randomized controlled CHANGE-3 trial
Anja Wollny, Attila Altiner, Tonia Brand, Katharina Garbe, Martina Kamradt, Petra Kaufmann-Kolle, Mirko Leyh, Regina Poß-Doering, Joachim Szecsenyi, Lorenz Uhlmann, Arwed Voss, Dorothea Weber, Michel Wensing, Christin Löffler
Evaluating the effect and mechanism of upper limb motor function recovery induced by immersive virtual-reality-based rehabilitation for subacute stroke subjects: study protocol for a randomized controlled trial
Qianqian Huang, Wei Wu, Xiaolong Chen, Bo Wu, Longqiang Wu, Xiaoli Huang, Songhe Jiang, Lejian Huang
CARer-ADministration of as-needed subcutaneous medication for breakthrough symptoms in homebased dying patients (CARiAD): study protocol for a UK-based open randomised pilot trial
Marlise Poolman, Jessica Roberts, Anthony Byrne, Paul Perkins, Zoe Hoare, Annmarie Nelson, Julia Hiscock, Dyfrig Hughes, Betty Foster, Julie O’Connor, Liz Reymond, Sue Healy, Rossela Roberts, Bee Wee, Penney Lewis, Rosalynde Johnstone, Sian Roberts, Emily Holmes, Stella Wright, Annie Hendry, Clare Wilkinson
COSUTI: a protocol for the development of a core outcome set (COS) for interventions for the treatment of uncomplicated urinary tract infection (UTI) in adults
Sinead Duane, Akke Vellinga, Andrew W. Murphy, Martin Cormican, Andrew Smyth, Patricia Healy, Michael Moore, Paul Little, Declan Devane
Stroke aetiological classification reliability and effect on trial sample size: systematic review, meta-analysis and statistical modelling
Azmil H. Abdul-Rahim, David Alexander Dickie, Johann R. Selvarajah, Kennedy R. Lees, Terence J. Quinn, K. R. Lees, A. Alexandrov, P. M. Bath, E. Berge, E. Bluhmki, N. Bornstein, C. Chen, L. Claesson, S. M. Davis, G. Donnan, H. C. Diener, M. Fisher, M. Ginsberg, B. Gregson, J. Grotta, W. Hacke, M. G. Hennerici, M. Hommel, M. Kaste, P. Lyden, J. Marler, K. Muir, N. Venketasubramanian, R. Sacco, A. Shuaib, P. Teal, N. G. Wahlgren, S. Warach, C. Weimar
Design and implementation of a large and complex trial in emergency medical services
Maria J. Robinson, Jodi Taylor, Stephen J. Brett, Jerry P. Nolan, Matthew Thomas, Barnaby C. Reeves, Chris A. Rogers, Sarah Voss, Madeleine Clout, Jonathan R. Benger
Physical Activity In Renal Disease (PAIRED) and the effect on hypertension: study protocol for a randomized controlled trial
Stephanie Thompson, Natasha Wiebe, Gabor Gyenes, Rachelle Davies, Jeyasundar Radhakrishnan, Michelle Graham
Yokukansan for perioperative psychiatric symptoms in cancer patients undergoing high invasive surgery. J-SUPPORT 1605 (ProD Study): study protocol for a randomized controlled trial
Saho Wada, Ryoichi Sadahiro, Yutaka J. Matsuoka, Yosuke Uchitomi, Takuhiro Yamaguchi, Ken Shimizu
How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions
Marco J. Haenssgen, Nutcha Charoenboon, Nga T. T. Do, Thomas Althaus, Yuzana Khine Zaw, Heiman F. L. Wertheim, Yoel Lubell
VIA Family—a family-based early intervention versus treatment as usual for familial high-risk children: a study protocol for a randomized clinical trial
Anne D. Müller, Ida C. T. Gjøde, Mette S. Eigil, Helle Busck, Merete Bonne, Merete Nordentoft, Anne A. E. Thorup
Sensory integration therapy versus usual care for sensory processing difficulties in autism spectrum disorder in children: study protocol for a pragmatic randomised controlled trial
Elizabeth Randell, Rachel McNamara, Sue Delport, Monica Busse, Richard P. Hastings, David Gillespie, Rhys Williams-Thomas, Lucy Brookes-Howell, Renee Romeo, Janet Boadu, Alka S. Ahuja, Anne Marie McKigney, Martin Knapp, Kathryn Smith, Jacqui Thornton, Gemma Warren
Impact of physical activity in vascular cognitive impairment (AFIVASC): study protocol for a randomised controlled trial
Ana Verdelho, Sofia Madureira, Manuel Correia, José Manuel Ferro, Mário Rodrigues, Manuel Gonçalves-Pereira, Mafalda Gonçalves, Ana Catarina Santos, Pedro Vilela, Helena Bárrios, Mariana Borges, Helena Santa-Clara
Effect of multi-lumen perfusion line on catheter-related bacteremia in premature infants: study protocol for a cluster-randomized crossover trial
Aurélie Maiguy-Foinard, Bertrand Décaudin, Pierre Tourneux, Bernard Guillois, Thierry Blanc, Sophie Galène-Gromez, Morgane Masse, Pascal Odou, Fannette Denies, Benoît Dervaux, Alain Duhamel, Laurent Storme
Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement
Jamie J. Kirkham, Sarah Gorst, Douglas G. Altman, Jane M. Blazeby, Mike Clarke, Sean Tunis, Paula R. Williamson, Adrian Aldcroft, Heather Bagley, Bronwen Connolly, Sarah Gorst, Jamie J. Kirkham, Tianjing Li, Karen Matvienko-Sikar, Victoria Thomas, Sean Tunis, Paula R. Williamson
Combination of acupuncture and Chinese herbal formula for elderly adults with mild cognitive impairment: protocol for a randomized controlled trial
Yueqi Chen, Wenjing Zhang, Huangan Wu, Lixing Lao, Jian Xu, Shifen Xu
COMPare: a prospective cohort study correcting and monitoring 58 misreported trials in real time
Ben Goldacre, Henry Drysdale, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley, Cicely Marston, Anna Powell-Smith, Carl Heneghan, Kamal R. Mahtani
Patient and public involvement (PPI) in UK surgical trials: a survey and focus groups with stakeholders to identify practices, views, and experiences
Joanna C. Crocker, Keira Pratt-Boyden, Jenny Hislop, Sian Rees, Louise Locock, Sophie Olszowski, Alan Chant, Shaun Treweek, Jonathan A. Cook, Kerry Woolfall, Nicola Farrar, Jennifer Bostock, Richard Bulbulia
The Oxford study of Calcium channel Antagonism, Cognition, Mood instability and Sleep (OxCaMS): study protocol for a randomised controlled, experimental medicine study
Lauren Z. Atkinson, Lucy Colbourne, Alexander Smith, Catherine H. Harmer, Anna C. Nobre, Jennifer Rendell, Helen Jones, Christopher Hinds, Arne Mould, Elizabeth M. Tunbridge, Andrea Cipriani, John R. Geddes, Kate E. A. Saunders, Paul J. Harrison
Paramedic Acute Stroke Treatment Assessment (PASTA): study protocol for a randomised controlled trial
Christopher I. Price, Lisa Shaw, Peter Dodd, Catherine Exley, Darren Flynn, Richard Francis, Saiful Islam, Mehdi Javanbakht, Rachel Lakey, Joanne Lally, Graham McClelland, Peter McMeekin, Helen Rodgers, Helen Snooks, Louise Sutcliffe, Pippa Tyrell, Luke Vale, Alan Watkins, Gary A. Ford
Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial
Noemi Lois, Evie Gardner, Norman Waugh, Augusto Azuara-Blanco, Hema Mistry, Danny McAuley, Nachiketa Acharya, Tariq M. Aslam, Clare Bailey, Victor Chong, Louise Downey, Haralabos Eleftheriadis, Samia Fatum, Sheena George, Faruque Ghanchi, Markus Groppe, Robin Hamilton, Geeta Menon, Ahmed Saad, Sobha Sivaprasad, Marianne Shiew, David H. Steel, James Stephen Talks, Catherine Adams, Christina Campbell, Matthew Mills, Mike Clarke, Noemi Lois, Evie Gardner, Norman Waugh, Augusto Azuara-Blanco, Hema Mistry, Danny McAuley, Mike Clarke, Tariq M. Aslam, Clare Bailey, Tomas Burke, Victor Chong, Sobha Sivaprasad, David H. Steel, James Stephen Talks, Catherine Adams, Christina Campbell, Matthew Mills, Paul Doherty, Aby Joseph, Nachiketa Acharya, Seema Arora, Harbhajan Kaur Arora, Mandeep S. Bindra, Farahat Butt, Manju Chandran, Richard Cheong-Leen, Mark Costen, Bhatia Devangna, Louise Downey, Stefanos Efraimidis, Haralabos Eleftheriadis, Abdallah Ellaban, Samia Fatum, Mohamed Galal, Sheena George, Faruque Ghanchi, Kala Gopalakrishnan, Markus Groppe, Robin Hamilton, Maged S. Habib, Christine Kiire, Arun Kikkeri, Zeid Madanat, Krishnappa Madhusudhana, Sely Mathew, Ahmed Saad, Serena Salvatore, Peter Scanlon, Muhammad Shaikh, Marianne Shiew
Comment on the trial protocol “Early versus late BCG vaccination in HIV-1-exposed infants in Uganda: study protocol for a randomized controlled trial”
Sanne Marie Thysen, Ane Bærent Fisker
COMPare: Qualitative analysis of researchers’ responses to critical correspondence on a cohort of 58 misreported trials
Ben Goldacre, Henry Drysdale, Cicely Marston, Kamal R. Mahtani, Aaron Dale, Ioan Milosevic, Eirion Slade, Philip Hartley, Carl Heneghan
Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS): study protocol for a prospective, randomized, double-blind, non-inferiority trial
Shangyi Hui, Liyuan Tao, Feroze Mahmood, Derong Xu, Zhinan Ren, Xin Chen, Lin Sheng, Qianyu Zhuang, Shugang Li, Yuguang Huang
The cerebral mechanism of acupuncture for treating knee osteoarthritis: study protocol for a randomized controlled trial
Jing Guo, Yang Chen, Zhengjie Li, Shirui Cheng, Chenjian Tang, Xiaohui Dong, Wenhua He, Yong Huang, Bao Yin, Yu Sheng, Jun Zhou, Aijia Li, Fang Zeng, Lei Lan, Fanrong Liang
Efficacy and safety of umbilical therapy with the traditional Chinese medicine formulation Lishui Xiaogu cataplasm for cirrhotic ascites: protocol for a randomized controlled trial
Xianzhao Yang, Shuying Ru, Lin Luo, Xiaoying Lv, Wenjing Bai, Fuwen Zhang, Feng Jiang
Binge-eating disorder treatment goes online – feasibility, usability, and treatment outcome of an Internet-based treatment for binge-eating disorder: study protocol for a three-arm randomized controlled trial including an immediate treatment, a waitlist, and a placebo control group
Simone Munsch, Andrea Wyssen, Pierre Vanhulst, Denis Lalanne, Sharon T. Steinemann, Alexandre Tuch
Anaesthetist-controlled versus patient-maintained effect-site targeted propofol sedation during elective primary lower-limb arthroplasty performed under spinal anaesthesia (ACCEPTS): study protocol for a parallel-group randomised comparison trial
David W. Hewson, Frank Worcester, James Sprinks, Murray D. Smith, Heather Buchanan, Philip Breedon, Jonathan G. Hardman, Nigel M. Bedforth
Study of negative pressure wound therapy as an adjunct treatment for acute burns in children (SONATA in C): protocol for a randomised controlled trial
Cody C. Frear, Bronwyn Griffin, Leila Cuttle, Steven M. McPhail, Roy Kimble
How can we successfully recruit depressed people? Lessons learned in recruiting depressed participants to a multi-site trial of a brief depression intervention (the ‘CLASSIC’ trial)
June S. L. Brown, Caroline Murphy, Joanna Kelly, Kimberley Goldsmith
Pulmonary rehabilitation in patients with mustard gas lung disease: a study protocol for a randomized controlled trial
Mohamad Reza Sedighi Moghadam, Mostafa Ghanei, Klaus Kenn, Nicholas S. Hopkinson
A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial
Lai Xu, Zhi-Yan Tao, Jun-Yang Lu, Guan-Nan Zhang, Hui-Zhong Qiu, Bin Wu, Guo-Le Lin, Tao Xu, Yi Xiao
Acceptability and feasibility of a 12-week yoga vs. educational film program for the management of restless legs syndrome (RLS): study protocol for a randomized controlled trial
Terry Kit Selfe, Sijin Wen, Karen Sherman, Maryanna Klatt, Kim E. Innes
Effects of blood flow restriction exercise with very low load and low volume in patients with knee osteoarthritis: protocol for a randomized trial
Mikhail Santos Cerqueira, Wouber Hérickson de Brito Vieira
Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial
Sheling Xie, Peng Yan, Chen Yao, Xiaoyan Yan, Yuliang Huo, Junhua Zhang, Si Liu, Zhiqiao Feng, Hongcai Shang, Lixin Xie
A parent-led intervention to promote recovery following pediatric injury: study protocol for a randomized controlled trial
Meghan L. Marsac, Ginny Sprang, Leila Guller, Kristen L. Kohser, John M. Draus Jr, Nancy Kassam-Adams
Impact of two oral doses of 100,000 IU of vitamin D3 in preschoolers with viral-induced asthma: a pilot randomised controlled trial
Francine Monique Ducharme, Megan Jensen, Geneviève Mailhot, Nathalie Alos, John White, Elizabeth Rousseau, Sze Man Tse, Ali Khamessan, Benjamin Vinet
The SURV1VE trial—sustained inflation and chest compression versus 3:1 chest compression-to-ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns: study protocol for a cluster randomized controlled trial
Georg M. Schmölzer, Gerhard Pichler, Anne Lee Solevåg, Caroline Fray, Sylvia van Os, Po-Yin Cheung
Efficacy and safety of gyejigachulbutang (Gui-Zhi-Jia-Shu-Fu-Tang, Keishikajutsubuto, TJ-18) for knee pain in patients with degenerative knee osteoarthritis: a randomized, placebo-controlled, patient and assessor blinded clinical trial
Jae-Uk Sul, Myung Kwan Kim, Jungtae Leem, Hee-Geun Jo, Sang-hoon Yoon, Jeeyong Kim, Eun-Jung Lee, Jeong-Eun Yoo, So Jung Park, Young Il Kim, Eunseok Kim, In Chul Jung, Ju-Hyun Jeon, Yang-Chun Park
SWATted away: the challenging experience of setting up a programme of SWATs in paediatric trials
Jacqueline Martin-Kerry, Adwoa Parker, Peter Bower, Ian Watt, Shaun Treweek, David Torgerson, Catherine Arundel, Peter Knapp
Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate: study protocol for a multicentre randomised placebo controlled non-inferiority trial (CITrUS trial)
Benjamin Speich, Kathrin Bausch, Jan A. Roth, Lars G. Hemkens, Hannah Ewald, Deborah R. Vogt, Nicole Bruni, Stefanie Deuster, Hans-H. Seifert, Andreas F. Widmer
Efficacy and safety of levothyroxine (L-T4) replacement on the exercise capability in chronic systolic heart failure patients with subclinical hypothyroidism: Study protocol for a multi-center, open label, randomized, parallel group trial (ThyroHeart-CHF)
Xuan Zhang, Wen-yao Wang, Kuo Zhang, Jian Tian, Ji-lin Zheng, Jing Chen, Shi-min An, Si-yuan Wang, Yu-peng Liu, Yan Zhao, Jing-jia Wang, Min Yang, Yi-da Tang
Evaluation of the effect of an antenatal pelvic floor muscle exercise programme on female sexual function during pregnancy and the first 3 months following birth: study protocol for a pragmatic randomised controlled trial
Sahar Sadat Sobhgol, Holly Priddis, Caroline A. Smith, Hannah Grace Dahlen
Oxytocin-enhanced motivational interviewing group therapy for methamphetamine use disorder in men who have sex with men: study protocol for a randomized controlled trial
Christopher S. Stauffer, Jenna M. Moschetto, Scott M. McKernan, Elaine Hsiang, Brian Borsari, Joshua D. Woolley
Modulation of frontal EEG alpha oscillations during maintenance and emergence phases of general anaesthesia to improve early neurocognitive recovery in older patients: protocol for a randomised controlled trial
Amy Gaskell, Rebecca Pullon, Darren Hight, Jonathan Termaat, Gay Mans, Logan Voss, Matthias Kreuzer, Sebastian Schmid, Stephan Kratzer, Amy Rodriguez, Gerhard Schneider, Paul Garcia, Jamie Sleigh
Tobacco cessation mobile app intervention (Just Kwit! study): protocol for a pilot randomized controlled pragmatic trial
Kar-Hai Chu, César G. Escobar-Viera, Sara J. Matheny, Esa M. Davis, Brian A. Primack
Mixed-methods approach to evaluate an mHealth intervention to increase adherence to triage of human papillomavirus-positive women who have performed self-collection (the ATICA study): study protocol for a hybrid type I cluster randomized effectiveness-implementation trial
Silvina Arrossi, Melisa Paolino, Liliana Orellana, Laura Thouyaret, Racquel E. Kohler, Kasisomayajula Viswanath
Rationale and design of PASSAT — patients’ satisfaction with local or general anaesthesia in video-assisted thoracoscopic surgery: study protocol for a randomised controlled trial with a non-randomised side arm
Thomas Galetin, Pascal Bretzke, Alberto Lopez-Pastorini, Mark Schieren, Aris Koryllos, Nils Kosse, Jost Schnell, Jerome M. Defosse, Frank Wappler, Erich Stoelben
The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam
Mary DeSilva, Cong Nguyen Vu, Rachael Bonawitz, Le Thanh Hai, Nguyen Van Lam, Le Thi Yen, Allen L. Gifford, Jessica Haberer, Dang Thuy Linh, Lora Sabin
Statistical design and analysis in trials of proportionate interventions: a systematic review
Jane Candlish, M. Dawn Teare, Judith Cohen, Tracey Bywater
Conditional cash transfers to retain rural Kenyan women in the continuum of care during pregnancy, birth and the postnatal period: protocol for a cluster randomized controlled trial
Caroline A. Ochieng, Hassan Haghparast-Bidgoli, Neha Batura, Aloyce Odhiambo, Geordan Shannon, Andrew Copas, Tom Palmer, Sarah Dickin, Stacey Noel, Matthew Fielding, Sangoro Onyango, Sarah Odera, Alie Eleveld, Alex Mwaki, Fedra Vanhuyse, Jolene Skordis
Effects of vitamin D supplementation on liver fibrogenic factors in non-alcoholic fatty liver patients with steatohepatitis: study protocol for a randomized clinical trial
Soraiya Ebrahimpour-Koujan, Amir Ali Sohrabpour, Farshad Foroughi, Ehsan Alvandi, Ahmad Esmaillzadeh
The DESiGN trial (DEtection of Small for Gestational age Neonate), evaluating the effect of the Growth Assessment Protocol (GAP): study protocol for a randomised controlled trial
Matias C. Vieira, Sophie Relph, Andrew Copas, Andrew Healey, Kirstie Coxon, Alessandro Alagna, Annette Briley, Mark Johnson, Deborah A. Lawlor, Christoph Lees, Neil Marlow, Lesley McCowan, Louise Page, Donald Peebles, Andrew Shennan, Baskaran Thilaganathan, Asma Khalil, Jane Sandall, Dharmintra Pasupathy, Peter Brocklehurst, Susan Tebbs, Caroline Doré, Paul Seed, Louisa Delaney, Janet Cresswell, Sarah Petty, Bini Ajay, Beverley Wright, Hannah O’Donnell, Melissa Howard, Emma Wayman, Paula Galea, Mandish Dhanjal, Elisa Iaschi, Vanessa Hodge, Hiran Samarage, Sunder Chita, Raffaele Napolitano, Iris Tsikimi, Fiona Ghalustians, Spyros Bakalis, Simona Cicero, Elisabeth Peregrine, Lyndsey Smith, Deepa Janga, Renata Hutt, Edwin Chandraharan
Jin’s three-needle acupuncture technique for chronic fatigue syndrome: a study protocol for a multicentre, randomized, controlled trial
Wenjia Lin, Xin-lin Chen, Qi Chen, Junmao Wen, Xinghua Chen
Personalized medicine with IgGAM compared with standard of care for treatment of peritonitis after infectious source control (the PEPPER trial): study protocol for a randomized controlled trial
Christina Kalvelage, Kai Zacharowski, Artur Bauhofer, Ulrich Gockel, Michael Adamzik, Axel Nierhaus, Peter Kujath, Christian Eckmann, Mathias W. Pletz, Hendrik Bracht, Tim-Philipp Simon, Michael Winkler, Detlef Kindgen-Milles, Markus Albertsmeier, Markus Weigand, Björn Ellger, Maximilian Ragaller, Roman Ullrich, Gernot Marx
Using discrete choice experiments to inform the design of complex interventions
Fern Terris-Prestholt, Nyasule Neke, Jonathan M. Grund, Marya Plotkin, Evodius Kuringe, Haika Osaki, Jason J. Ong, Joseph D. Tucker, Gerry Mshana, Hally Mahler, Helen A. Weiss, Mwita Wambura
Mental Health Prevention in Preschool Children: study protocol for a feasibility and acceptability randomised controlled trial of a culturally adapted version of the I Can Problem Solve (ICPS) Programme in Chile
Jorge Gaete, Marcelo Sánchez, Lorena Nejaz, Mikele Otegui
The ASSIST Study - The BD Odon Device for assisted vaginal birth: a safety and feasibility study
Stephen O’Brien, Emily J. Hotton, Erik Lenguerrand, Julia Wade, Cathy Winter, Tim J. Draycott, Joanna F. Crofts, Mary Alvarez, Sabaratnum Arulkumaran, Nichola Bale, Natalie Blencowe, Joanna F. Crofts, Timothy J. Draycott, Lily Exell, Anne Glover, Sally Hall, Emily J. Hotton, Erik Lenguerrand, Helen Lewis-White, Naomi Mallinson, Michelle Mayer, Sadie McKeown-Keegan, Glen Mola, Stephen O’Brien, Alison Pike, Iona Smith, Claire Rose, Sherrie Villis, Julia Wade, Paul White, Cathy Winter
Impact of renin-angiotensin system inhibitors continuation versus discontinuation on outcome after major surgery: protocol of a multicenter randomized, controlled trial (STOP-or-NOT trial)
Matthieu Legrand, Emmanuel Futier, Marc Leone, Benjamin Deniau, Alexandre Mebazaa, Benoît Plaud, Pierre Coriat, Patrick Rossignol, Eric Vicaut, Etienne Gayat
Improving outcome reporting in clinical trial reports and protocols: study protocol for the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT)
Nancy J. Butcher, Andrea Monsour, Emma J. Mew, Peter Szatmari, Agostino Pierro, Lauren E. Kelly, Mufiza Farid-Kapadia, Alyssandra Chee-a-tow, Leena Saeed, Suneeta Monga, Wendy Ungar, Caroline B. Terwee, Sunita Vohra, Dean Fergusson, Lisa M. Askie, Paula R. Williamson, An-Wen Chan, David Moher, Martin Offringa
Optimal strategy of primary percutaneous coronary intervention for acute myocardial infarction due to unprotected left main coronary artery occlusion (OPTIMAL): study protocol for a randomised controlled trial
Yang Gao, Feng Zhang, Chenguang Li, Yuxiang Dai, Ji’e Yang, Ya’nan Qu, Juying Qian, Junbo Ge
The effect of manual therapy and exercise on age-related lung function: study protocol for a randomised controlled trial
Roger Engel, Sandra Grace, Suzanne Broadbent
Role of cerebral hypoperfusion in multiple sclerosis (ROCHIMS): study protocol for a proof-of-concept randomized controlled trial with bosentan
Stéphanie Hostenbach, Ayla Pauwels, Veronique Michiels, Hubert Raeymaekers, Anne-Marie Van Binst, Annick Van Merhaeghen-Wieleman, Peter Van Schuerbeek, Jacques De Keyser, Miguel D’Haeseleer
Effects of transcranial direct current stimulation on the rehabilitation of painful shoulder following a stroke: protocol for a randomized, controlled, double-blind, clinical trial
Janaina Andressa de Souza, João Carlos Ferrari Corrêa, Letizzia Dall’ Agnol, Filipe Ribeiro dos Santos, Márcia Rafaella Pereira Gomes, Fernanda Ishida Corrêa
Flexible video endoscope versus Macintosh laryngoscope for orotracheal tracheal intubation in the lateral position: a study protocol for a randomized controlled trial
Youguang Gao, Bo Lin, Jinghao Huang, Xianzhong Lin, Caizhu Lin
The effect of repeated remote ischemic postconditioning on infarct size in patients with an ischemic stroke (REPOST): study protocol for a randomized clinical trial
Thijs Landman, Yvonne Schoon, Michiel Warlé, Frank-Erik De Leeuw, Dick Thijssen
Upper limb strength training in subacute stroke patients: study protocol of a randomised controlled trial
Susan Högg, Manfred Holzgraefe, Insa Wingendorf, Jan Mehrholz, Christoph Herrmann, Mark Obermann
Evaluation of repositories for sharing individual-participant data from clinical studies
Rita Banzi, Steve Canham, Wolfgang Kuchinke, Karmela Krleza-Jeric, Jacques Demotes-Mainard, Christian Ohmann
Application via mechanical dropper alleviates sufentanil-induced cough: a prospective, randomized, single-blinded trial
Minqiang Liu, Zhichao Li, Song Wang, Yong Liu, Xiangpeng Zhong, Renliang He, Fengxian Li
Effects of Lysulin™ supplementation on pre-diabetes: study protocol for a randomized controlled trial
Priyanga Ranasinghe, Ranil Jayawardena, Lal Chandrasena, Vivianne Noetzel, John Burd
Combined test versus logrank/Cox test in 50 randomised trials
Patrick Royston, Babak Choodari-Oskooei, Mahesh K. B. Parmar, Jennifer K. Rogers
Comparing efficacy and safety between Naldebain® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial
Hsiang-Lin Tsai, Tsung-Kun Chang, Wei-Chih Su, Yung-Sung Yeh, Ching-Wen Huang, Cheng-Jen Ma, Jaw-Yuan Wang
Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial
Silje Haukenes Stavestrand, Kristine Sirevåg, Inger Hilde Nordhus, Trond Sjøbø, Trygve Bruun Endal, Hans M. Nordahl, Karsten Specht, Åsa Hammar, Anne Halmøy, Egil W. Martinsen, Eva Andersson, Helene Hjelmervik, Jan Mohlman, Julian F. Thayer, Anders Hovland
Correction to: 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
Multimorbidity risk assessment in adolescents and adults with cerebral palsy: a protocol for establishing a core outcome set for clinical research and practice
Patrick G. McPhee, Joyce L. Benner, Astrid C. J. Balemans, Olaf Verschuren, Rita J. G. van den Berg-Emons, Edward A. Hurvitz, Mark D. Peterson, Wilma M. A. van der Slot, Marij E. Roebroeck, Jan Willem Gorter
A single-blind, dose-escalation, phase I study of high-fluence light-emitting diode-red light on Caucasian non-Hispanic skin: study protocol for a randomized controlled trial
Erica B. Wang, Ramanjot Kaur, Julie Nguyen, Derek Ho, Evan Austin, Emanual Maverakis, Chin-Shang Li, Samuel T. Hwang, R. Rivkah Isseroff, Jared Jagdeo
Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): an investigator-initiated, randomized, multi-center, multi-national, clinical trial on additional cerebral tissue oxygen saturation monitoring combined with defined treatment guidelines versus standard monitoring and treatment as usual in premature infants during immediate transition: study protocol for a randomized controlled trial
Gerhard Pichler, Sigrid Baumgartner, Marlene Biermayr, Eugene Dempsey, Hans Fuchs, Tom G. Goos, Gianluca Lista, Laila Lorenz, Lukasz Karpinski, Souvik Mitra, Lilijana Kornhauser-Cerar, Alexander Avian, Berndt Urlesberger, Georg M. Schmölzer
What is the impact of mother’s bed incline on episodes of decreased oxygen saturation in healthy newborns in skin-to-skin contact after delivery: Study protocol for a randomized controlled trial
Jesús Rodríguez López, Nadia Raquel García Lara, María López Maestro, Javier De la Cruz Bértolo, José Carlos Martínez Ávila, Máximo Vento, Ana Parra Llorca, Isabel Izquierdo Macián, Adelina Pellicer, Natalia Marín Huarte, Izaskun Asla Elorriaga, Lourdes Román Echevarría, Cristina Copons Fernández, Ana Martín Ancel, Fernando Cabañas, Óscar García Algar, Carmen Rosa Pallás Alonso
Effect of electro-acupuncture on lateralization of the human swallowing motor cortex excitability in healthy subjects: study protocol for a single-blind, randomized controlled trial
Minying Li, Lin Wang, Nenggui Xu, Xiaorong Tang, Mindong Xu, Jianhua Liu, Jianpeng Huang, Judith M. Schlaeger
Enhancing practitioners’ confidence in recruitment and consent in the EcLiPSE trial: a mixed-method evaluation of site training – a Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI) study
Kerry Woolfall, Louise Roper, Amy Humphreys, Mark D. Lyttle, Shrouk Messahel, Elizabeth Lee, Joanne Noblet, Anand Iyer, Carrol Gamble, Helen Hickey, Naomi Rainford, Richard Appleton
Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation
Clifton O. Bingham III, Carol L. Gaich, Amy M. DeLozier, Kathryn D. Engstrom, April N. Naegeli, Stephanie de Bono, Pixy Banerjee, Peter C. Taylor
The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial
Rustam Al-Shahi Salman, Gordon D. Murray, Martin S. Dennis, David E. Newby, Peter A. G. Sandercock, Nikola Sprigg, Cathie L. M. Sudlow, David J. Werring, Philip M. White, William N. Whiteley
A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control of atopic dermatitis: study protocol for a multicentre, randomized, crossover, pragmatic trial – the PRADA trial
Catherine Droitcourt, Sébastien Barbarot, Annabel Maruani, Laure Darrieux, Laurent Misery, Emilie Brenaut, Henri Adamski, Cécile Chabbert, Annie Vermersch, Marie Weiborn, Julien Seneschal, Alain Taïeb, Patrice Plantin, Hervé Maillard, Alice Phan, François Skowron, Manuelle Viguier, Delphine Staumont-Salle, Audrey Nosbaum, Angèle Soria, Annick Barbaud, Emmanuel Oger, Alain Dupuy
Use of a Geographic Information System to create treatment groups for group-randomized community trials: The Minnesota Heart Health Program
Brittany Krzyzanowski, Steven M. Manson, Milton Mickey Eder, Len Kne, Niki Oldenburg, Kevin Peterson, Alan T. Hirsch, Russell V. Luepker, Sue Duval
Wound Healing In Surgery for Trauma (WHIST): statistical analysis plan for a randomised controlled trial comparing standard wound management with negative pressure wound therapy
Ruth Knight, Louise M. Spoors, Matthew L. Costa, Susan J. Dutton
Binafuxi granules in the treatment of common cold with heat syndrome based on traditional Uighur medicine: study protocol for a multicenter randomized controlled trial
Jie Min, Bin She, Xin Zhang, Bing Mao, Yan Chen
Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
Mike Ralf Langenbach, Dörthe Seidel
Effects of a programme of vigorous physical activity during secondary school physical education on academic performance, fitness, cognition, mental health and the brain of adolescents (Fit to Study): study protocol for a cluster-randomised trial
T. M. Wassenaar, C. M. Wheatley, N. Beale, P. Salvan, A. Meaney, J. B. Possee, K. E. Atherton, J. L. Duda, H. Dawes, H. Johansen-Berg
An individualised versus a conventional pneumoperitoneum pressure strategy during colorectal laparoscopic surgery: rationale and study protocol for a multicentre randomised clinical study
O. Diaz-Cambronero, G. Mazzinari, C. L. Errando, M. J. Schultz, B. Flor Lorente, N. García-Gregorio, M. Vila Montañés, Daniel Robles-Hernández, L. E. Olmedilla Arnal, A. Martín-De-Pablos, A. Marqués Marí, M. P. Argente Navarro, Oscar Díaz-Cambronero, Blas Flor-Lorente, Guido Mazzinari, María Vila-Montañés, Nuria García-Gregorio, Maria Jose Alberola-Estellés, Begoña Ayas-Montero, Salome Matoses-Jaén, Sandra Verdeguer, Anabel Marqués Marí, Jose Miguel Alonso Íñigo, Josep Balaguer Domenech, Marisol Echeverri Velez, David Cuesta-Frau, Maria Pilar Argente-Navarro, Salvador Pous, Cristina Ballester, Matteo Frasson, Alvaro García-Granero, Carlos Cerdán-Santacruz, Eduardo García-Granero, Luis Sánchez-Guillén, Daniel Robles-Hernández, David Boquera-Albert, David Casado-Rodrigo, Rebeca Cosa-Rodríguez, Luis Enrique Olmedilla-Arnal, Marcos Rodríguez-Martín, Jaime Zorrilla-Ortúzar, José María Pérez-Peña, Angel Martín-de-Pablos, Javier Valdés-Hernández, Juan Carlos Gómez-Rosado, Pino Heredia-Pérez, Juan Cintas-Catena, Fernando Flor-Parra, Marcus J. Schultz, Carlos Luis Errando Oyonarte
Evaluating the effects of the novel GLP-1 analogue liraglutide in Alzheimer’s disease: study protocol for a randomised controlled trial (ELAD study)
Grazia Daniela Femminella, Eleni Frangou, Sharon B. Love, Gail Busza, Clive Holmes, Craig Ritchie, Robert Lawrence, Brady McFarlane, George Tadros, Basil H. Ridha, Carol Bannister, Zuzana Walker, Hilary Archer, Elizabeth Coulthard, Ben R. Underwood, Aparna Prasanna, Paul Koranteng, Salman Karim, Kehinde Junaid, Bernadette McGuinness, Ramin Nilforooshan, Ajay Macharouthu, Andrew Donaldson, Simon Thacker, Gregor Russell, Naghma Malik, Vandana Mate, Lucy Knight, Sajeev Kshemendran, John Harrison, David J. Brooks, Anthony Peter Passmore, Clive Ballard, Paul Edison
Estimating Site Performance (ESP): can trial managers predict recruitment success at trial sites? An exploratory study
Hanne Bruhn, Shaun Treweek, Anne Duncan, Kirsty Shearer, Sarah Cameron, Karen Campbell, Karen Innes, Dawn McRae, Seonaidh C. Cotton
Improving primary care Access in Context and Theory (I-ACT trial): a theory-informed randomised cluster feasibility trial using a realist perspective
John A. Ford, Andy P. Jones, Geoff Wong, Garry Barton, Allan Clark, Erika Sims, Ann Marie Swart, Nick Steel
Protocol and baseline data for a prospective open-label explorative randomized single-center comparative study to determine the effects of various intravenous iron preparations on markers of oxidative stress and kidney injury in chronic kidney disease (IRON-CKD)
Ahmed Ziedan, Sunil Bhandari
Pre- and Apnoeic high flow oxygenation for RApid sequence intubation in The Emergency department (Pre-AeRATE): study protocol for a multicentre, randomised controlled trial
Mui Teng Chua, Faheem Ahmed Khan, Wei Ming Ng, Qingshu Lu, Matthew Jian Wen Low, Ying Wei Yau, Amila Punyadasa, Win Sen Kuan
Short-term versus long-term mentalization-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder: a protocol for a randomized clinical trial
Sophie Juul, Susanne Lunn, Stig Poulsen, Per Sørensen, Mehrak Salimi, Janus Christian Jakobsen, Anthony Bateman, Sebastian Simonsen
The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) Protocol: a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial
David N. Hager, Michael H. Hooper, Gordon R. Bernard, Laurence W. Busse, E. Wesley Ely, Alpha A. Fowler, David F. Gaieski, Alex Hall, Jeremiah S. Hinson, James C. Jackson, Gabor D. Kelen, Mark Levine, Christopher J. Lindsell, Richard E. Malone, Anna McGlothlin, Richard E. Rothman, Kert Viele, David W. Wright, Jonathan E. Sevransky, Greg S. Martin
The iBobbly Aboriginal and Torres Strait Islander app project: Study protocol for a randomised controlled trial
Fiona Shand, Andrew Mackinnon, Kathleen O’Moore, Rebecca Ridani, Bill Reda, Mel Hoy, Todd Heard, Luke Duffy, Marian Shanahan, Lisa Jackson Pulver, Helen Christensen
Evaluation of the efficacy of transcranial direct current stimulation in the treatment of cognitive symptomatology in the early stages of psychosis: study protocol for a double-blind randomized controlled trial
Thais Rabanea-Souza, Sheila M. C. Cirigola, Cristiano Noto, July S. Gomes, Caroline C. Azevedo, Ary Gadelha, Quirino Cordeiro, Álvaro M. Dias, Acioly L. T. Lacerda
Photobiomodulation therapy on the palliative care of temporomandibular disorder and orofacial/cervical skull pain: study protocol for a randomized controlled clinical trial
Fernando Rodrigues Carvalho, Rafael Queiroz Barros, Alyne Simões Gonçalves, Patrícia Moreira Freitas
Correction to: 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
The life expectancy of patients with metabolic syndrome after weight loss: study protocol for a randomized clinical trial (LIFEXPE-RT)
Oral Ospanov, Galymzhan Yeleuov, Irina Kadyrova, Farida Bekmurzinova
Protocol update and statistical analysis plan for CADENCE-BZ: a randomized clinical trial to assess the efficacy of sodium benzoate as an adjunctive treatment in early psychosis
Carmen Lim, Andrea Baker, Sukanta Saha, Sharon Foley, Anne Gordon, David Ward, Bjorn Burgher, Frances Dark, Martin Beckmann, Stephen Stathis, George Bruxner, Alex Ryan, Drew Richardson, Sean Hatherill, Michael Berk, Olivia Dean, John McGrath, Justin Chapman, Susan Patterson, Saveena Singh, Bryan Mowry, Linda Tracy, Michael Duhig, Amy Machin, Elizabeth Troman, Shuichi Suetani, Thomas Dinala, Lucinda Burton, Peter Cosgrove, Clare Gamble, James Scott
Correction to: Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: study protocol for a randomised controlled trial
Jian-Feng Tu, Jing-Wen Yang, Lu-Lu Lin, Tian-Qi Wang, Yu-Zheng Du, Zhi-Shun Liu, Hui Hu, Jing-Jie Zhao, Xiao-Gang Yu, Chun-Sheng Jia, Jun Wang, Tong Wang, Ya-Quan Hou, Xuan Zou, Yu Wang, Jia-Kai Shao, Li-Qiong Wang, Zhang-Sheng Yu, Cun-Zhi Liu
Randomized controlled trial of transcutaneous electrical nerve stimulation for pain relief during transvaginal oocyte retrieval using conscious sedation: study protocol for a randomized controlled trial
Queenie Ho Yan Wong, Man Wa Lui, Sofie Shuk Fei Yung, Jennifer Ka Yee Ko, Raymond Hang Wun Li, Ernest Hung Yu Ng
Chemoradiation versus oesophagectomy for locally advanced oesophageal cancer in Chinese patients: study protocol for a randomised controlled trial
Ruinuo Jia, Weijiao Yin, Shuoguo Li, Ruonan Li, Junqiang Yang, Tanyou Shan, Dan Zhou, Wei Wang, Lixin Wan, Fuyou Zhou, Shegan Gao
Optimising recruitment into trials using an internal pilot
W. Bertram, A. Moore, V. Wylde, R. Gooberman-Hill
The effect of an expanded long-term periodization exercise training on physical fitness in patients with coronary artery disease: study protocol for a randomized controlled trial
Rita Pinto, Vitor Angarten, Vanessa Santos, Xavier Melo, Helena Santa-Clara
Nebulized versus intravenous morphine titration for the initial treatment of severe acute pain in the emergency department: study protocol for a multicenter, prospective randomized and controlled trial, CLIN-AEROMORPH
Virginie Eve Lvovschi, Justine Joly, Nicolas Lemaire, Maxime Maignan, Pauline Canavaggio, Anne-Marie Leroi, Marie-Pierre Tavolacci, Luc-Marie Joly
Re-endothelialisation after Synergy stent and Absorb bioresorbable vascular scaffold implantation in acute myocardial infarction: COVER-AMI study
Thibault Lhermusier, Paul Ohayon, Nicolas Boudou, Frederic Bouisset, Francisco Campelo-Parada, Jerome Roncalli, Meyer Elbaz, Didier Carrié
Correction to: 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
Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials
Yorokpa Joachim Doua, Hanneke Dominicus, Julius Mugwagwa, Suzelle Magalie Gombe, Jude Nwokike
Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial
T. Kiss, J. Wittenstein, C. Becker, K. Birr, G. Cinnella, E. Cohen, M. R. El Tahan, L. F. Falcão, C. Gregoretti, M. Granell, T. Hachenberg, M. W. Hollmann, R. Jankovic, W. Karzai, J. Krassler, T. Loop, M. J. Licker, N. Marczin, G. H. Mills, M. T. Murrell, V. Neskovic, Z. Nisnevitch-Savarese, P. Pelosi, R. Rossaint, M. J. Schultz, A. Serpa Neto, P. Severgnini, L. Szegedi, T. Vegh, G. Voyagis, J. Zhong, M. Gama de Abreu, M. Senturk, Vojislava Neskovic, Nevena Radovic, Goran Rondovic, Dusica Stamenkovic, Rade Vukovic, Snjezana Zeba, Rolf Rossaint, Mark Coburn, Ana Kowark, Sebastian Ziemann, Julia van Waesberghe, Wolfgang Bauer, Lotte Terwindt, Kostas Kostopanagiotou, Andreas Kostroglou, Katerina Kyttari, Tatiana Sidiropoulou, María-José Jiménez Andújar, Manuel López-Baamonde, Ricard Navarro Ripoll, Lorena Rivera Vallejo, Matthew Henry, Anita Jegarl, Matthew Murrell, Patrick O’Hara, Michele Steinkamp, Jens Kraßler, Susanne Schäfer, Charlotte Becker, Katja Birr, Thomas Bluth, Marcelo Gama de Abreu, Sara Hattenhauer, Thomas Kiss, Martin Scharffenberg, Robert Teichmann, Jakob Wittenstein, Costanza Vitali, Savino Spadaro, Carlo Alberto Volta, Riccardo Ragazzi, Karim Mariano, Lucia Mirabella, Giuseppina Mollica, Luigi Montrano, Torsten Loop, Axel Semmelmann, Steffen Wirth, Changhong Miao, Jing Zhong, Hu Lv, Hui Wang, Xue Zhang, Yue Zhang, Paolo Pelosi, Laura Corsi, Nicolò Partroniti, Maura Mandelli, Giulia Bonatti, Francesca Simonassi, Angelo Gratarola, Juan José Rodriguez Ruiz, Tania Socorro, Maria Christofaki, Vasileia Nyktari, Alexandra Papaioannou, Nüzhet Mert Şentürk, Emre Bingul, Mukadder Orhan Sungur, Zerrin Sungur, Manuel Heidegger, Vera Dossow, Wiebke Jerichow, Tobias Kammerer, Julia Richter, Barbara Schuba, Eike Speck, Anna-Lisa Stierle, Jan Bruthans, Jan Matek, Pavel Michálek, Loes Didden, Jan Hofland, Marieke Kuut, Jo Mourisse, Sonsoles Aragon, Rafael Esturi, Encarna Miñana, Fernando Sanchez, Elaine Sfikas, Athanasios Kapezanos, Konstantinos Papamichail, Levon Toufektzian, Gregorios Voyagis, Manuel Granell Gil, Asunción Vergara Sánchez, José De Andres, Javier Morales Sarabia, Ana Broseta Lleó, Javier Hernández Laforet, Mercedes Murcia Anaya, Denis Pereira Matalobos, Pilar Aguirre Puig, Jasna Špiček Macan, Vjekoslav Karadza, Nevenka Kolaric, Lea Andjelković, Mojca Drnovšek Globokar, Kristina Gorjup, Ana Mavko, Dejan Pirc, Cadar Genoveva, Raluca Istrate, Radu Stoica, Dan Corneci, Narcis Valentin Tanase, Jankovic Radmilo, Vladan Cvetanovic, Vesna Dinic, Tijana Grbesa, Katarina Jovic, Aleksandar Nikolic, Milena Stojanovic, Ines Veselinovic, Anita Vukovic, Frank Wappler, Jerome Michel Defosse, Stefanie Wehmeier, Thomas Ermert, Carola Wempe, Manuel Wenk, Daniela Iolanda Ion, Cristian Ionescu, Thomas Schilling, Tamar Macharadze, Pei-Ching Li, Yi-Ting Chang, Alberto Noto, Placido Calì, Giovanni Desalvo, Raffaele Deluca, Nicola Giofre
Safety and efficacy of curcumin versus diclofenac in knee osteoarthritis: a randomized open-label parallel-arm study
Dhaneshwar Shep, Chitra Khanwelkar, Prakashchandra Gade, Satyanand Karad
Evaluation of the masticatory muscle function, physiological sleep variables, and salivary parameters after electromechanical therapeutic approaches in adult patients with Down syndrome: a randomized controlled clinical trial
Lilian Chrystiane Giannasi, Marignês T. S. Dutra, Vera L. S. Tenguan, Gabriela P. Mancilha, Gabriela R. C. Silva, Elaine Fillietaz-Bacigalupo, Daniel B. da Silva, Fabiano Politti, Sergio R. Nacif, Ezequiel F. de Oliveira, João C. da Rocha, Carolina T. Rocha, Mateus M. Romero, Claudia S. de Oliveira, Luis V. F. de Oliveira, Sigmar de Mello Rode, Cristiane Yumi Koga-Ito, Jose B. O. Amorim, Miguel A. C. Salgado, Mônica F. Gomes
Comparative effectiveness of Chuna manual therapy versus conventional usual care for non-acute low back pain: a pilot randomized controlled trial
Kyeong-Tae Lim, Eui-Hyoung Hwang, Jae-Heung Cho, Jae-Young Jung, Koh-Woon Kim, In-Hyuk Ha, Me-riong Kim, Kibong Nam, Min ho Lee A, Jun-Hwan Lee, Namkwen Kim, Byung-Cheul Shin
The efficacy and safety of Sipjeondaebo-tang in Korean patients with cold hypersensitivity in the hands and feet: a protocol for a pilot, randomized, double-blind, placebo-controlled, parallel-group clinical trial
Youme Ko, Seung-Ho Sun, In-Sik Han, Ho-Yeon Go, Tae-Hun Kim, Jin-Moo Lee, Jun-Bok Jang, Kyoung Sun Park, Yun-Kyung Song, Kyou-Young Lee, Chan-Yong Jeon, Seong-Gyu Ko
Songling Xuemaikang capsules for patients with low-to-medium risk hypertension: study protocol for a randomized controlled trial
Yuerong Jiang, Haiyan Guo, Yue Liu, Xin Wang, Jiaqi Liang, Ruixi Xi, Ruina Bai, Dazhuo Shi
Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD Study) – study protocol for a randomised placebo-controlled trial in Australia
Roseanne Peel, Alexis Hure, John Wiggers, Mark McEvoy, Elizabeth Holliday, Andrew Searles, Penny Reeves, Priyanga Ranasinghe, Ranil Jayawardena, Samir Samman, Shamasunder Acharya, Judy Luu, Chris Rissel, John Attia
Evaluation of intravenous lidocaine in head and neck cancer surgery: study protocol for a randomized controlled trial
Edris Omar, Grégoire Wallon, Christian Bauer, Grégory Axiotis, Cécile Bouix, Jean-Luc Soubirou, Frédéric Aubrun
The effectiveness of high intensity intermittent training on metabolic, reproductive and mental health in women with polycystic ovary syndrome: study protocol for the iHIT- randomised controlled trial
Danielle Hiam, Rhiannon Patten, Melanie Gibson-Helm, Alba Moreno-Asso, Luke McIlvenna, Itamar Levinger, Cheryce Harrison, Lisa J Moran, Anju Joham, Alex Parker, Soulmaz Shorakae, David Simar, Nigel Stepto
Efficacy and Feasibility of Pain management and Patient Education for Physical Activity in Intermittent claudication (PrEPAID): protocol for a randomised controlled trial
Ukachukwu O. Abaraogu, Philippa M. Dall, Julie Brittenden, Wesley Stuart, Garry A. Tew, Jon Godwin, Christopher A. Seenan
Uro-Vaxom® versus placebo for the prevention of recurrent symptomatic urinary tract infections in participants with chronic neurogenic bladder dysfunction: a randomised controlled feasibility study
Derick Wade, James Cooper, Fadel Derry, Julian Taylor
Pre-trial qualitative work with health care professionals to refine the design and delivery of a randomised controlled trial on kidney care
Samantha Husbands, Fergus Caskey, Helen Winton, Andy Gibson, Jenny L. Donovan, Leila Rooshenas
Women’s experiences of participating in a randomised trial comparing alternative policies for timing of cord clamping at very preterm birth: a questionnaire study
Lucy Bradshaw, Alexandra Sawyer, Eleanor Mitchell, Lindsay Armstrong-Buisseret, Susan Ayers, Lelia Duley
Novel optical spectral transmission (OST)-guided versus conventionally disease activity-guided treatment: study protocol of a randomized clinical trial on guidance of a treat-to-target strategy for early rheumatoid arthritis
N. J. Besselink, A. A. A. Westgeest, R. Klaasen, M. Gamala, J. M. van Woerkom, J. Tekstra, M. M. A. Verhoeven, W. E. Van Spil, F. P. J. G. Lafeber, A. C. A. Marijnissen, J. M. Van Laar, J. W. G. Jacobs
Implementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system
Carlos Diaz-Montana, William J. Cragg, Rahela Choudhury, Nicola Joffe, Matthew R. Sydes, Sally P. Stenning
A randomized controlled trial of an intervention delivered by mobile phone text message to increase the acceptability of effective contraception among young women in Palestine
Ona L. McCarthy, Hanadi Zghayyer, Amina Stavridis, Samia Adada, Irrfan Ahamed, Baptiste Leurent, Phil Edwards, Melissa Palmer, Caroline Free
Structural and functional brain biomarkers of clinical response to rTMS of medication-resistant auditory hallucinations in schizophrenia patients: study protocol for a randomized sham-controlled double-blind clinical trial
Fanny Thomas, Noomane Bouaziz, Cécile Gallea, Palmyre Schenin-King Andrianisaina, Florence Durand, Ombline Bolloré, René Benadhira, Clémence Isaac, Sonia Braha-Zeitoun, Virginie Moulier, Antoni Valero-Cabré, Dominique Januel
Expert panel process to optimise the design of a randomised controlled trial in chronic rhinosinusitis (the MACRO programme)
Helen Blackshaw, Jane Vennik, Carl Philpott, Mike Thomas, Caroline Eyles, James Carpenter, Caroline S. Clarke, Steve Morris, Anne Schilder, Valerie Lund, Paul Little, Stephen Durham, Spiros Denaxas, Elizabeth Williamson, David Beard, Jonathan Cook, Steffi Le Conte, Kim Airey, Jim Boardman, Claire Hopkins
Effects of different modalities of inspiratory muscle training as an add-on to conventional treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a randomized controlled trial
Catharinne Angélica Carvalho de Farias, Lucien Peroni Gualdi, Selma Bruno da Silva, Verônica Franco Parreira, Dayane Montemezzo, Vanessa R. Resqueti, Guilherme A. F. Fregonezi
Retrograde Inferior Vena caval Perfusion for Total Aortic arch Replacement Surgery (RIVP-TARS): study protocol for a multicenter, randomized controlled trial
Jing Lin, Zhaoxia Tan, Hao Yao, Xiaolin Hu, Dafa Zhang, Yuan Zhao, Jiyue Xiong, Bo Dou, Xueshuang Zhu, Zhong Wu, Yingqiang Guo, Deying Kang, Lei Du
Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales
Victoria Shepherd, Fiona Wood, Richard Griffith, Mark Sheehan, Kerenza Hood
Promoting physical activity among community groups of older women in socio-economically disadvantaged areas: randomised feasibility study
Emma R. Lawlor, Margaret E. Cupples, Michael Donnelly, Mark A. Tully
Growing Healthy Together: protocol for a randomized clinical trial using parent mentors for early childhood obesity intervention in a Latino community
Byron A. Foster, Kelsey Weinstein, Jackilen Shannon
Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: study protocol for a multi-centre randomized controlled trial
Daniel-Mihai Rusu, Ianis Siriopol, Ioana Grigoras, Mihaela Blaj, Adi-Ionut Ciumanghel, Dimitrie Siriopol, Ionut Nistor, Mihai Onofriescu, Gigel Sandu, Beatrice Cobzaru, Dragos Viorel Scripcariu, Olguta Diaconu, Adrian Constantin Covic
Long-term effects of motherfit group therapy in pre-(MOTHERFIT1) and post-partum women (MOTHERFIT2) with stress urinary incontinence compared to care-as-usual: study protocol of two multi-centred, randomised controlled trials
Heidi F. A. Moossdorff-Steinhauser, Esther M. J. Bols, Marc E. A. Spaanderman, Carmen D. Dirksen, Mirjam Weemhoff, Fred H. M. Nieman, Bary Berghmans
Community-based interventions to prevent serious complications following spinal cord injury in Bangladesh: the CIVIC trial statistical analysis plan
Robert D. Herbert, Lisa A. Harvey, Mohammad S. Hossain, Md. Shofiqul Islam, Qiang Li, Laurent Billot, Md. Akhlasur Rahman, Stephen Muldoon, Stephen Jan, Valerie Taylor, Ian D. Cameron, Harvinder Singh Chhabra, Richard I. Lindley, Fin Biering-Sørensen
Postponed or immediate drainage of infected necrotizing pancreatitis (POINTER trial): study protocol for a randomized controlled trial
Janneke van Grinsven, Sven M. van Dijk, Marcel G. Dijkgraaf, Marja A. Boermeester, Thomas L. Bollen, Marco J. Bruno, Sandra van Brunschot, Cornelis H. Dejong, Casper H. van Eijck, Krijn P. van Lienden, Djamila Boerma, Peter van Duijvendijk, Muhammed Hadithi, Jan Willem Haveman, René W. van der Hulst, Jeroen M. Jansen, Daan J. Lips, Eric R. Manusama, I. Quintus Molenaar, Donald L. van der Peet, Alexander C. Poen, Rutger Quispel, Alexander F. Schaapherder, Erik J. Schoon, Matthijs P. Schwartz, Tom C. Seerden, B. W. Marcel Spanier, Jan Willem Straathof, Niels G. Venneman, Wim van de Vrie, Ben J. Witteman, Harry van Goor, Paul Fockens, Hjalmar C. van Santvoort, Marc G. Besselink
Protocol for a randomised controlled feasibility study examining the efficacy of brief cognitive therapy for the Treatment of Anxiety Disorders in Adolescents (TAD-A)
Lucy Taylor, Polly Waite, Brynjar Halldorsson, Ray Percy, Mara Violato, Cathy Creswell
Early warnings and repayment plans: novel trial management methods for monitoring and managing data return rates in a multi-centre phase III randomised controlled trial with paper Case Report Forms
William J. Cragg, Fay Cafferty, Carlos Diaz-Montana, Elizabeth C. James, Johnathan Joffe, Monica Mascarenhas, Victoria Yorke-Edwards
A double-blind randomized comparative clinical trial to evaluate the safety and efficacy of dendritic cell vaccine loaded with WT1 peptides (TLP0-001) in combination with S-1 in patients with advanced pancreatic cancer refractory to standard chemotherapy
Masahiro Katsuda, Motoki Miyazawa, Toshiyasu Ojima, Akio Katanuma, Kenichi Hakamada, Kentaro Sudo, Shingo Asahara, Itaru Endo, Makoto Ueno, Kazuo Hara, Suguru Yamada, Tsutomu Fujii, Sohei Satoi, Tatsuya Ioka, Masaichi Ohira, Takahiro Akahori, Masayuki Kitano, Hiroaki Nagano, Masayuki Furukawa, Tomohiko Adachi, Hiroki Yamaue
A targeted interprofessional educational intervention to address therapeutic adherence of venous leg ulcer persons (TIEIVLU): study protocol for a randomized controlled trial
Sebastian Probst, Lara Allet, Jocelyne Depeyre, Sophie Colin, Monika Buehrer Skinner
Enhancing the efficacy of integrative improvisational music therapy in the treatment of depression: study protocol for a randomised controlled trial
Jaakko Erkkilä, Olivier Brabant, Suvi Saarikallio, Esa Ala-Ruona, Martin Hartmann, Nerdinga Letulė, Monika Geretsegger, Christian Gold
All-trans-retinoic acid (ATRA) plus oxaliplatin plus 5-fluorouracil/leucovorin (FOLFOX) versus FOLFOX alone as palliative chemotherapy in patients with advanced hepatocellular carcinoma and extrahepatic metastasis: study protocol for a randomized controlled trial
Jie Shi, Juxian Sun, Chang Liu, Zongtao Chai, Nanya Wang, Hui Zhang, Shuqun Cheng
Clarithromycin and endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps: study protocol for the MACRO randomised controlled trial
Carl Philpott, Steffi le Conte, David Beard, Jonathan Cook, William Sones, Steve Morris, Caroline S. Clarke, Mike Thomas, Paul Little, Jane Vennik, Valerie Lund, Helen Blackshaw, Anne Schilder, Stephen Durham, Spiros Denaxas, James Carpenter, James Boardman, Claire Hopkins, Neil Med, Keith Boland, Jane Woods, Teresa Ferreira
Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial
Thaddeus W. W. Pace, Sally E. Dodds, Alla Sikorskii, Terry A. Badger, Chris Segrin, Lobsang Tenzin Negi, Timothy Harrison, Tracy E. Crane
Addition of a new three-dimensional adjustable cervical thoracic orthosis to a multi-modal program in the treatment of nonspecific neck pain: study protocol for a randomised pilot trial
Ahmed S. A. Youssef, Nan Xia, Shimaa T. E. Emara, Ibrahim M. Moustafa, Xiaolin Huang
Multicenter randomized controlled trial on the comparison of multi-family therapy (MFT) and systemic single-family therapy (SFT) in young patients with anorexia nervosa: study protocol of the THERAFAMBEST study
Benjamin Carrot, Jeanne Duclos, Caroline Barry, Leslie Radon, Anne-Solène Maria, Irène Kaganski, Zorica Jeremic, Vesper Barton-Clegg, Maurice Corcos, Malaïka Lasfar, Priscille Gerardin, Aurélie Harf, Marie-Rose Moro, Corinne Blanchet, Nathalie Godart
Efficacy of seven and fourteen days of antibiotic treatment in uncomplicated Staphylococcus aureus bacteremia (SAB7): study protocol for a randomized controlled trial
Louise Thorlacius-Ussing, Christian Østergaard Andersen, Niels Frimodt-Møller, Inge Jenny Dahl Knudsen, Jens Lundgren, Thomas Lars Benfield
Iron-fortified lentils to improve iron (Fe) status among adolescent girls in Bangladesh - study protocol for a double-blind community-based randomized controlled trial
Fakir Md Yunus, Chowdhury Jalal, Kaosar Afsana, Rajib Podder, Albert Vandenberg, Diane M. DellaValle
Effects of inclined treadmill training on functional and cardiovascular parameters of stroke patients: study protocol for a randomized controlled trial
Raiff Simplício da Silva, Stephano Tomaz da Silva, Jesimiel Missias de Souza, Marianna Celeste Cordeiro de Figueiredo, Thaís Almeida Silveira Mendes, Maria Clara de Sena Nunes, Samara Katiane Rolim de Oliveira, Daiane Carla Rodrigues Cardoso, Raiza Gabriella da Câmara Silva, Débora Carvalho de Oliveira, Tatiana Souza Ribeiro
The effects of two early parenting interventions on child aggression and risk for violence in Brazil (The PIÁ Trial): protocol for a randomised controlled trial
Joseph Murray, Iná S. Santos, Andréa D. Bertoldi, Lynne Murray, Adriane Arteche, Luciana Tovo-Rodrigues, Suélen Cruz, Luciana Anselmi, Rafaela Martins, Elisa Altafim, Tâmara Biolo Soares, Maria Gabriela Andriotti, Andrea Gonzalez, Isabel Oliveira, Mariângela Freitas da Silveira, Peter Cooper
Ventilation strategies with different inhaled Oxygen conceNTration during CardioPulmonary Bypass in cardiac surgery (VONTCPB): study protocol for a randomized controlled trial
Meng-Qiu Zhang, Yu-Qi Liao, Hong Yu, Xue-Fei Li, Liang Feng, Xiao-Yun Yang, Hai Yu
Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial
Kamal Maheshwari, Tetsuya Shimada, Jonathan Fang, Ilker Ince, Edward J. Mascha, Alparslan Turan, Andrea Kurz, Daniel I. Sessler
Targeted interventions to prevent transitioning from acute to chronic low back pain in high-risk patients: development and delivery of a pragmatic training course of psychologically informed physical therapy for the TARGET trial
Jason M. Beneciuk, Steven Z. George, Carol M. Greco, Michael J. Schneider, Stephen T. Wegener, Robert B. Saper, Anthony Delitto
Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M)
Alice Pressman, Heather Law, Robert Stahl, Alex Scott, Alice Jacobson, Lisa Dean, Sylvia Sudat, Angelica Obillo, Andrew Avins
Critical inspiratory pressure – a new methodology for evaluating and training the inspiratory musculature for recreational cyclists: study protocol for a randomized controlled trial
Patricia Rehder-Santos, Vinicius Minatel, Juliana Cristina Milan-Mattos, Étore De Favari Signini, Raphael Martins de Abreu, Carla Cristina Dato, Aparecida Maria Catai
Correction to: Protective ventilation with high versus low positive end-expiratory pressure during one-lung ventilation for thoracic surgery (PROTHOR): study protocol for a randomized controlled trial
T. Kiss, J. Wittenstein, C. Becker, K. Birr, G. Cinnella, E. Cohen, M. R. El Tahan, L. F. Falcão, C. Gregoretti, M. Granell, T. Hachenberg, M. W. Hollmann, R. Jankovic, W. Karzai, J. Krassler, T. Loop, M. J. Licker, N. Marczin, G. H. Mills, M. T. Murrell, V. Neskovic, Z. Nisnevitch-Savarese, P. Pelosi, R. Rossaint, M. J. Schultz, A. Serpa Neto, P. Severgnini, L. Szegedi, T. Vegh, G. Voyagis, J. Zhong, M. Gama de Abreu, M. Senturk
Effectiveness and pulmonary complications of perioperative laryngeal mask airway used in elderly patients (POLMA-EP trial): study protocol for a randomized controlled trial
Ling Zhu, Xiao Shi, Suqing Yin, Jiemin Yin, Ziyu Zhu, Xiong Gao, Yingfu Jiao, Weifeng Yu, Liqun Yang
Knee Replacement Bandaging Study (KReBS) evaluating the effect of a two-layer compression bandage system on knee function following total knee arthroplasty: study protocol for a randomised controlled trial
Liz Cook, Matthew J. Northgraves, Caroline Fairhurst, Sarah Ronaldson, David J. Torgerson, Jonathan Kent, Mike Reed
Partner-assisted cognitive behavioural therapy for insomnia versus cognitive behavioural therapy for insomnia: a randomised controlled trial
Alix Mellor, Kellie Hamill, Melissa M. Jenkins, Donald H. Baucom, Peter J. Norton, Sean P. A. Drummond
MEsenchymal StEm cells for Multiple Sclerosis (MESEMS): a randomized, double blind, cross-over phase I/II clinical trial with autologous mesenchymal stem cells for the therapy of multiple sclerosis
Antonio Uccelli, Alice Laroni, Lou Brundin, Michel Clanet, Oscar Fernandez, Seyed Massood Nabavi, Paolo A. Muraro, Roberto S. Oliveri, Ernst W. Radue, Johann Sellner, Per Soelberg Sorensen, Maria Pia Sormani, Jens Thomas Wuerfel, Mario A. Battaglia, Mark S. Freedman, Alice Laroni, Antonio Uccelli, Bruno Bonetti, Carolina Rush, Concepción Herrera, Cristina Ramo Tello, David Miller, David Szwajcer, Dirk Strunk, Donna Wall, Eduardo Aguera-Morales, Ernst W. Radue, Eva Rohde, Francesco Dazzi, Giancarlo Comi, Gianvito Martino, Guillermo Izquierdo Ayuso, H. Rabinovitch, Heather MacLean, James Marriott, Jens Thomas Wuerfel, Johann Sellner, Juan Racosta, Leila Arab, Lou Brundin, Maria Pia Sormani, Mario A. Battaglia, Mario Gimona, Mark S. Freedman, Martino Introna, Michel Clanet, Morten Blinkenberg, Naser Aghdami, Óscar Fernández, Paolo A. Muraro, Per Soelberg Sorensen, Rehiana Ali, Reza Vosoughi, Richard Nicholas, Roberto S. Oliveri, Ruth Ann Marrie, Seyed Massood Nabavi, Shahedeh Karimi
This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols
Francesca Schiavone, Riya Bathia, Krishna Letchemanan, Lindsey Masters, Claire Amos, Anna Bara, Louise Brown, Clare Gilson, Cheryl Pugh, Nafisah Atako, Fleur Hudson, Mahesh Parmar, Ruth Langley, Richard S. Kaplan, Chris Parker, Gert Attard, Noel W. Clarke, Silke Gillessen, Nicholas D. James, Tim Maughan, Matthew R. Sydes
Guiding Hypertension Management Using Different Blood Pressure Monitoring Strategies (GYMNs study): comparison of three different blood pressure measurement methods: study protocol for a randomized controlled trial
Hao-Min Cheng, Shih-Hsien Sung, Chen-Huan Chen, Wen-Chung Yu, Shu-Mei Yang, Chao-Yu Guo, Shao-Yuan Chuang, Chern-En Chiang
Factors associated with recruitment to randomised controlled trials in general practice: protocol for a systematic review
Keith R. Moffat, Paul Cannon, Wen Shi, Frank Sullivan
Correction to: 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
Video feedback intervention to enhance parental reflective functioning in primary caregivers of inpatient psychiatric children: protocol for a randomized feasibility trial
Fanny Leyton, Marcia Olhaberry, Rubén Alvarado, Graciela Rojas, Luis Alberto Dueñas, George Downing, Howard Steele
Efficacy of the In2Care® auto-dissemination device for reducing dengue transmission: study protocol for a parallel, two-armed cluster randomised trial in the Philippines
Ferdinand Salazar, Jason Angeles, Ava Kristy Sy, Marianette T. Inobaya, Ariza Aguila, Tom Toner, Michael J. Bangs, Edward Thomsen, Richard E. Paul
A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asian women: study protocol for a cluster randomized wait-list controlled trial
Cho Lee Wong, Winnie Kwok Wei So, Dorothy Ngo Sheung Chan, Kai Chow Choi, Tika Rana
POPPIE: protocol for a randomised controlled pilot trial of continuity of midwifery care for women at increased risk of preterm birth
C. Fernandez Turienzo, D. Bick, M. Bollard, L. Brigante, A. Briley, K. Coxon, P. Cross, A. Healey, M. Mehta, A. Melaugh, J. Moulla, P. T. Seed, A. H. Shennan, C. Singh, R. M. Tribe, J. Sandall
Are stage-based health information messages effective and good value for money in improving maternal newborn and child health outcomes in India? Protocol for an individually randomized controlled trial
Amnesty LeFevre, Smisha Agarwal, Sara Chamberlain, Kerry Scott, Anna Godfrey, Rakesh Chandra, Aditya Singh, Neha Shah, Diva Dhar, Alain Labrique, Aarushi Bhatnagar, Diwakar Mohan
Protocol for a randomised controlled trial to evaluate the effectiveness of improving tuberculosis patients’ treatment adherence via electronic monitors and an app versus usual care in Tibet
Xiaolin Wei, Joseph Paul Hicks, Pande Pasang, Zhitong Zhang, Victoria Haldane, Xiaoqiu Liu, Tingting Yin, Lixia Wang, Dachun Shi, Shiliang Ge, John Walley, Ross Upshur, Jun Hu
Correction to: Tamponade dressings versus no tamponade after hemorrhoidectomy: study protocol for a randomized controlled trial
Mike Ralf Langenbach, Dörthe Seidel
Improvement in staff behavior during surgical procedures to prevent post-operative complications (ARIBO2): study protocol for a cluster randomised trial
Gabriel Birgand, Thomas Haudebourg, Leslie Grammatico-Guillon, Léa Ferrand, Leila Moret, François Gouin, Nicolas Mauduit, Christophe Leux, Yannick Le Manach, Didier Lepelletier, Elsa Tavernier, Jean-Christophe Lucet, Bruno Giraudeau
Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial
Qing Yuan, Xulei Cui, Yuda Fei, Zhonghuang Xu, Yuguang Huang
Metacognitive therapy versus exposure and response prevention for obsessive-compulsive disorder: study protocol for a randomized controlled trial
Kim Melchior, Ingmar Franken, Mathijs Deen, Colin van der Heiden
Effect of home-based transcranial direct current stimulation (tDCS) on cognitive function in patients with mild cognitive impairment: a study protocol for a randomized, double-blind, cross-over study
Jaesub Park, Yoonkyung Oh, Kyungmi Chung, Kwang Joon Kim, Chang Oh Kim, Jin Young Park
FortiColos – a multicentre study using bovine colostrum as a fortifier to human milk in very preterm infants: study protocol for a randomised controlled pilot trial
Agnethe M. Ahnfeldt, Nana Hyldig, Yanqi Li, Susanne Soendergaard Kappel, Lise Aunsholdt, Per T. Sangild, Gitte Zachariassen
Effectiveness and cost-effectiveness of a tailored text-message programme (MiQuit) for smoking cessation in pregnancy: study protocol for a randomised controlled trial (RCT) and meta-analysis
Rachel Whitemore, Jo Leonardi-Bee, Felix Naughton, Stephen Sutton, Sue Cooper, Steve Parrott, Catherine Hewitt, Miranda Clark, Michael Ussher, Matthew Jones, David Torgerson, Tim Coleman
Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial
Martin Cour, Marielle Buisson, Kada Klouche, Radhia Bouzgarrou, Carole Schwebel, Jean-Pierre Quenot, Fabrice Zeni, Pascal Beuret, Michel Ovize, Laurent Argaud
Rationale and protocol of the ENGAGE study: a double-blind randomized controlled preference trial using a comprehensive cohort design to measure the effect of a cognitive and leisure-based intervention in older adults with a memory complaint
S. Belleville, A. Moussard, A. I. Ansaldo, P. Belchior, L. Bherer, N. Bier, V. D. Bohbot, M.-A. Bruneau, L. L. Cuddy, B. Gilbert, R. Jokel, K. Mahalingam, K. McGilton, K. J. Murphy, G. Naglie, E. Rochon, A. K. Troyer, N. D. Anderson
Effect and cerebral mechanism of acupuncture treatment for functional constipation: study protocol for a randomized controlled clinical trial
Tao Yin, Zhaoxuan He, Peihong Ma, Likai Hou, Li Chen, Kunnan Xie, Zilei Tian, Fumin Wang, Jing Xiong, Yi Yang, Ruirui Sun, Fang Zeng
Barriers to recruitment when conducting a commissioned randomised controlled trial of medication versus psychological therapy for generalised anxiety disorder: some lessons learned
Anastasia K. Kalpakidou, John Cape, Tarun J. Limbachya, Irwin Nazareth, Marta Buszewicz
Population health intervention research: the place of theories
Graham Moore, Linda Cambon, Susan Michie, Pierre Arwidson, Grégory Ninot, Christine Ferron, Louise Potvin, Nadir Kellou, Julie Charlesworth, François Alla, François Alla, Pierre Arwidson, Pierre Blaise, Christopher Bonell, Isabelle Boutron, Linda Cambon, Rona Campbell, Patrizia Carrieri, Franck Chauvin, François Dabis, Nancy Edwards, Christine Ferron, Marie-Renée Guevel, Nadir Kellou, Joëlle Kivits, Antony Lacouture, Thierry Lang, Susan Michie, Laëtitia Minary, Graham Moore, Grégory Ninot, Kareen Nour, Jeanine Pommier, Louise Potvin, Lehana Thabane
Study protocol for a randomized, blinded, controlled trial of ketamine for acute painful crisis of sickle cell disease
Mohammed S. Alshahrani, Laila Perlas Asonto, Mohamed M. El Tahan, Amal H. Al Sulaibikh, Sukayna Z. Al Faraj, Abdullah A. Al Mulhim, Murad F. Al Abbad, Samar A. Al Nahhash, Moath N. Aldarweesh, Alaa M. Mahmoud, Nisreen Almaghraby, Mohammed A. Al Jumaan, Thamir O. Al Junaid, Faisal M. Al Hawaj, Samar AlKenany, Omaima F. ElSayed, Haitham M. Abdelwahab, Mohamed M. Moussa, Bader K. Alossaimi, Shaikah K. Alotaibi, Talal M. AlMutairi, Duaa A. AlSulaiman, Saad D. Al Shahrani, Donia Alfaraj, Waleed Alhazzani
Protocol for the cost-consequence and equity impact analyses of a cluster randomised controlled trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child dietary diversity and nutritional status in rural Odisha, India (UPAVAN trial)
Hassan Haghparast-Bidgoli, Jolene Skordis, Helen Harris-Fry, Sneha Krishnan, Meghan O’Hearn, Abhinav Kumar, Ronali Pradhan, Naba Kishore Mishra, Avinash Upadhyay, Shibananth Pradhan, Amit Kumar Ojha, Sarah Cunningham, Shibanand Rath, Tom Palmer, Peggy Koniz-Booher, Suneetha Kadiyala
What happens to intimate partner violence studies registered on clinicaltrials.gov? A systematic review of a clinical trials registry
Kim Madden, Kerry Tai, Patricia Schneider, Nathan Evaniew, Michelle A. Ghert, Mohit Bhandari
Ambassadors of hope, research pioneers and agents of change—individuals’ expectations and experiences of taking part in a randomised trial of an innovative health technology: longitudinal qualitative study
Julia Lawton, Maxine Blackburn, Jenna P. Breckenridge, Nina Hallowell, Conor Farrington, David Rankin
Efficacy of post-procedural oral hydration volume on risk of contrast-induced acute kidney injury following primary percutaneous coronary intervention: study protocol for a randomized controlled trial
Feier Song, Guoli Sun, Jin Liu, Ji-yan Chen, Yibo He, Liwei Liu, Yong Liu
Efficacy of a midwife-coordinated, individualized, and specialized maternity care intervention (ChroPreg) in addition to standard care in pregnant women with chronic disease: protocol for a parallel randomized controlled trial
Mie Gaarskjaer de Wolff, Marianne Johansen, Anne S. Ersbøll, Susanne Rosthøj, Anne Brunsgaard, Julie Midtgaard, Ann Tabor, Hanne Kristine Hegaard
Single vs. double purse-string anastomosis during laparoscopic low anterior rectal resection (SINGLE–DOUBLE trial): study protocol for a randomized controlled trial
Xiaolan You, Jian Wu, Yuanjie Wang, Qinghong Liu, Dehu Chen, Xiaojun Zhao, Yan Zhou, Xiaoqing Wu, Daorong Wang
Choosing an imbalance metric for covariate-constrained randomization in multiple-arm cluster-randomized trials
Jody D. Ciolino, Alicia Diebold, Jessica K. Jensen, Gerald W. Rouleau, Kimberly K. Koloms, Darius Tandon
Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons
Dominic Hague, Stephen Townsend, Lindsey Masters, Mary Rauchenberger, Nadine Van Looy, Carlos Diaz-Montana, Melissa Gannon, Nicholas James, Tim Maughan, Mahesh K. B. Parmar, Louise Brown, Matthew R. Sydes
Effects of magnesium citrate, magnesium oxide and magnesium sulfate supplementation on arterial stiffness in healthy overweight individuals: a study protocol for a randomized controlled trial
Joëlle C. Schutten, Peter J. Joris, Ronald P. Mensink, Richard M. Danel, Frans Goorman, M. Rebecca Heiner-Fokkema, Rinse K. Weersma, Charlotte A. Keyzer, Martin H. de Borst, Stephan J. L. Bakker
Recruitment strategies for predominantly low-income, multi-racial/ethnic children and parents to 3-year community-based intervention trials: Childhood Obesity Prevention and Treatment Research (COPTR) Consortium
Zhaohui Cui, Kimberly P. Truesdale, Thomas N. Robinson, Victoria Pemberton, Simone A. French, Juan Escarfuller, Terri L. Casey, Anne M. Hotop, Donna Matheson, Charlotte A. Pratt, Lynn J. Lotas, Eli Po’e, Sharon Andrisin, Dianne S. Ward
Mind the gap? The platform trial as a working environment
Liz Morrell, Joshua Hordern, Louise Brown, Matthew R. Sydes, Claire L. Amos, Richard S. Kaplan, Mahesh K. B. Parmar, Timothy S. Maughan
Influence of an exercise program on cardiac remodeling and functional capacity in patients with stroke (CRONuS trial): study protocol for a randomized controlled trial
Josiela Cristina da Silva Rodrigues, Gustavo José Luvizutto, Rafael Dalle Molle da Costa, Robson Aparecido Prudente, Taís Regina da Silva, Juli Thomaz de Souza, Caroline Ferreira da Silva Mazeto Pupo da Silveira, Daniele Andreza Antonelli Rossi, Fernanda Cristina Winckler, Gabriel Pinheiro Modolo, Tainá Fabri Carneiro Valadão, Letícia Cláudia de Oliveira Antunes, Luis Cuadrado Martin, Rodrigo Bazan, Silméia Garcia Zanati Bazan
3D vs. 4K Display System - Influence of “State-of-the-art”-Display Technique On Surgical Performance (IDOSP-Study) in minimally invasive surgery: protocol for a randomized cross-over trial
Roger Wahba, Rabi Raj Datta, Andrea Hedergott, Jana Bußhoff, Thomas Bruns, Robert Kleinert, Georg Dieplinger, Hans Fuchs, Caroline Giezelt, Desdemona Möller, Martin Hellmich, Christiane J. Bruns, Dirk L. Stippel
Intraoperative immunomodulatory effects of sevoflurane versus total intravenous anesthesia with propofol in bariatric surgery (the OBESITA trial): study protocol for a randomized controlled pilot trial
Giselle Carvalho de Sousa, Fernanda Ferreira Cruz, Luciana Boavista Heil, Carlos José Saboya Sobrinho, Felipe Saddy, Frederico Paranhos Knibel, Joana Barreto Pereira, Marcus J. Schultz, Paolo Pelosi, Marcelo Gama de Abreu, Pedro Leme Silva, Patricia Rieken Macedo Rocco
Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements
Pia Dellson, Christina Carlsson, Mef Nilbert, Helena Jernström
Enhancing SKIN health and safety in aged CARE (SKINCARE Trial): a study protocol for an exploratory cluster-randomized pragmatic trial
Jan Kottner, Elisabeth Hahnel, Monira El Genedy, Konrad Neumann, Katrin Balzer
Effects on stress reduction of a modified mindfulness-based cognitive therapy for family caregivers of those with dementia: study protocol for a randomized controlled trial
Patrick Pui Kin Kor, Justina Yat-Wa Liu, Wai Tong Chien
Effects of intraoperative PEEP on postoperative pulmonary complications in patients undergoing robot-assisted laparoscopic radical resection for bladder cancer or prostate cancer: study protocol for a randomized controlled trial
Zhen-feng Zhou, Jun-biao Fang, Long Chen, Hong-fa Wang, Yong-jian Yu, Wen-yuan Wang, Jia-bao Chen, Miao-zun Zhang, Shuang-fei Hu
Effectiveness of a complex intervention to improve participation and activities in nursing home residents with joint contractures (JointConEval): study protocol of a multicentre cluster-randomised controlled trial [DRKS-ID:DRKS00015185]
Natalie Nguyen, Regina Thalhammer, Katrin Beutner, Susanne Saal, Ricarda Servaty, Hanna Klingshirn, Andrea Icks, Kristina Freyberg, Markus Vomhof, Ulrich Mansmann, Lien Le, Martin Müller, Gabriele Meyer
Efficacy of different-frequency TEAS on acute pain after the total knee arthroplasty: a study protocol for a parallel group randomized trial
Yulin Li, Lixi Chu, Xiangming Li, Weitao Zhai, Yinghui Ma, Yong He, Yuelin Xu, Sheng Ding, Huali Gao, Jing Zhang, Bowen Ye, Jingchao Wang, Jie Yao, Chonggui Wu, Lianbo Xiao
Is this study feasible? Facilitating management of pragmatic trial planning milestones under a phased award funding mechanism
Paula Darby Lipman, Leanora Dluzak, Catherine M. Stoney
Effect of acupuncture on insomnia in menopausal women: a study protocol for a randomized controlled trial
Shanshan Li, Ping Yin, Xuan Yin, Anna Bogachko, Tingting Liang, Lixing Lao, Shifen Xu
Population health intervention research: what is the place for pilot studies?
Lehana Thabane, Linda Cambon, Louise Potvin, Jeanine Pommier, Joëlle Kivits, Laetitia Minary, Kareen Nour, Pierre Blaise, Julie Charlesworth, François Alla, François Alla, Pierre Arwidson, Pierre Blaise, Christopher Bonell, Isabelle Boutron, Linda Cambon, Rona Campbell, Patrizia Carrieri, Franck Chauvin, François Dabis, Nancy Edwards, Christine Ferron, Marie-Renée Guevel, Nadir Kellou, Joëlle Kivits, Antony Lacouture, Thierry Lang, Susan Michie, Laëtitia Minary, Graham Moore, Grégory Ninot, Kareen Nour, Jeanine Pommier, Louise Potvin, Lehana Thabane
Neurocircuitry of acupuncture effect on cognitive improvement in patients with mild cognitive impairment using magnetic resonance imaging: a study protocol for a randomized controlled trial
Hyo-Weon Suh, Jieun Kim, Ojin Kwon, Seung-Hun Cho, Jong Woo Kim, Hui-Yong Kwak, Yunna Kim, Kyung Mi Lee, Sun-Yong Chung, Jun-Hwan Lee
Cast versus functional brace in the rehabilitation of patients with a rupture of the Achilles tendon: statistical analysis plan for the UK study of tendo Achilles rehabilitation (UK STAR) multi-centre randomised controlled trial
Ioana R. Marian, Matthew L. Costa, Susan J. Dutton
Anesthetics to Prevent Lung Injury in Cardiac Surgery (APLICS): a protocol for a randomized controlled trial
Brian O’Gara, Balachundhar Subramaniam, Shahzad Shaefi, Ariel Mueller, Valerie Banner-Goodspeed, Daniel Talmor
Who says “no” to participating in stroke clinical trials and why: an observational study from the Vancouver Stroke Program
Zoe R. O’Neill, Halina M. Deptuck, Lauren Quong, Genoveva Maclean, Karina Villaluna, Princess King-Azote, Mukul Sharma, Ken Butcher, Robert G. Hart, Thalia S. Field
A randomised controlled trial evaluating arrhythmia burden, risk of sudden cardiac death and stroke in patients with Fabry disease: the role of implantable loop recorders (RaILRoAD) compared with current standard practice
Ravi Vijapurapu, Rebecca Kozor, Derralynn A. Hughes, Peter Woolfson, Ana Jovanovic, Patrick Deegan, Rosemary Rusk, Gemma A. Figtree, Michel Tchan, David Whalley, Dipak Kotecha, Francisco Leyva, James Moon, Tarekegn Geberhiwot, Richard P. Steeds
Evaluation of the effect of oral taurine supplementation on fasting levels of fibroblast growth factors, β-Klotho co-receptor, some biochemical indices and body composition in obese women on a weight-loss diet: a study protocol for a double-blind, randomized controlled trial
Fatemeh Haidari, Maryam Asadi, Javad mohammadi-asl, Kambiz Ahmadi-Angali
RTS,S malaria vaccine pilot studies: addressing the human realities in large-scale clinical trials
Machteld van den Berg, Bernhards Ogutu, Nelson K. Sewankambo, Nikola Biller-Andorno, Marcel Tanner
Real-time foot clearance biofeedback to assist gait rehabilitation following stroke: a randomized controlled trial protocol
Rezaul Begg, Mary P. Galea, Lisa James, W. A. Tony Sparrow, Pazit Levinger, Fary Khan, Catherine M. Said
Achieving Self-Directed Integrated Cancer Aftercare (ASICA) in melanoma: protocol for a randomised patient-focused pilot trial of delivering the ASICA intervention as a means to earlier detection of recurrent and second primary melanoma
P. Murchie, J. Masthoff, F. M. Walter, K. Rahman, J. L. Allan, N. Burrows, C. Proby, A. J. Lee, M. Johnston, A. Durrani, I. Depasquale, B. Brant, A. Neilson, F. Meredith, S. Treweek, S. Hall, A. McDonald
A randomised controlled trial assessing the use of citalopram, sertraline, fluoxetine and mirtazapine in preventing relapse in primary care patients who are taking long-term maintenance antidepressants (ANTLER: ANTidepressants to prevent reLapse in dEpRession): study protocol for a randomised controlled trial
Larisa Duffy, Faye Bacon, Caroline S. Clarke, Yvonne Donkor, Nick Freemantle, Simon Gilbody, Rachael Hunter, Tony Kendrick, David Kessler, Michael King, Paul Lanham, Gemma Lewis, Dee Mangin, Louise Marston, Michael Moore, Irwin Nazareth, Nicola Wiles, Glyn Lewis
Evaluating the safety and feasibility of a new surgical treatment for forearm fractures in older children: study protocol for a randomised controlled trial
Chunhui Chen, Linzhen Xie, Wenhao Zheng, Hua Chen, Leyi Cai
LLIN Evaluation in Uganda Project (LLINEUP) – Impact of long-lasting insecticidal nets with, and without, piperonyl butoxide on malaria indicators in Uganda: study protocol for a cluster-randomised trial
Sarah G. Staedke, Moses R. Kamya, Grant Dorsey, Catherine Maiteki-Sebuguzi, Samuel Gonahasa, Adoke Yeka, Amy Lynd, Jimmy Opigo, Janet Hemingway, Martin J. Donnelly
Correction to: Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation
Clifton O. Bingham III, Carol L. Gaich, Amy M. DeLozier, Kathryn D. Engstrom, April N. Naegeli, Stephanie de Bono, Pixy Banerjee, Peter C. Taylor
The CHESS trial: protocol for the process evaluation of a randomised trial of an education and self-management intervention for people with chronic headache
Vivien P. Nichols, David R. Ellard, Frances E. Griffiths, Martin Underwood, Stephanie J. C. Taylor, Shilpa Patel, Arlene Wilkie, Brendan Davies, David Boss, David Ellard, Dawn Carnes, Felix Achana, Fiona Caldwell, Frances Griffiths, Harbinder Sandhu, Helen Higgins, Hema Mistry, Katrin Probyn, Kimberley White, Kirstie Haywood, Manjit Matharu, Martin Underwood, Mary Bright, Rachel Potter, Sandra Eldridge, Shilpa Patel, Siew Wan Hee, Simon Evans, Stavros Petrou, Stephanie Taylor, Tamar Pincus, Vivien Nichols
The effect of a heel-unloading orthosis in short-term treatment of calcaneus fractures on physical function, quality of life and return to work – study protocol for a randomized controlled trial
Hagen Schmal, Anders Holsgaard Larsen, Lonnie Froberg, Julie Ladeby Erichsen, Carsten Fladmose Madsen, Lasse Pedersen
A study protocol for the N-ICE trial: A randomised double-blind placebo-controlled study of the safety and efficacy of N-acetyl-cysteine (NAC) as a pharmacotherapy for methamphetamine (“ice”) dependence
Rebecca McKetin, Olivia M. Dean, Alyna Turner, Peter J. Kelly, Brendan Quinn, Dan I. Lubman, Paul Dietze, Gregory Carter, Peter Higgs, Amanda L. Baker, Barbara Sinclair, David Reid, Victoria Manning, Nina te Pas, Wenbin Liang, Tamsin Thomas, Ramez Bathish, Margaret Kent, Dayle Raftery, Shalini Arunogiri, Frank Cordaro, Harry Hill, Michael Berk
Efficacy and safety of acupuncture for patients with chronic urticaria: study protocol of a randomized, sham-controlled pilot trial
Yunzhou Shi, Hui Zheng, Siyuan Zhou, Qianhua Zheng, Leixiao Zhang, Xianjun Xiao, Wei Cao, Ying Liu, Ying Li
Pomegranate juice to reduce fecal calprotectin levels in inflammatory bowel disease patients with a high risk of clinical relapse: Study protocol for a randomized controlled trial
Eleonora Scaioli, Andrea Belluzzi, Luigi Ricciardiello, Daniele Del Rio, Enrica Rotondo, Pedro Mena, Eleonora Derlindati, Francesca Danesi
Protocol for a multi-centre pilot and feasibility randomised controlled trial with a nested qualitative study: rehabilitation following rotator cuff repair (the RaCeR study)
Chris Littlewood, Marcus Bateman, Kendra Cooke, Susie Hennnings, Tina Cookson, Kieran Bromley, Martyn Lewis, Lennard Funk, Jean Denton, Maria Moffatt, Rachel Winstanley, Saurabh Mehta, Gareth Stephens, Lisa Dikomitis, Linda Chesterton, Nadine E. Foster
Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions
Katy Davis, Nicole Minckas, Virginia Bond, Cari Jo Clark, Tim Colbourn, Sarah J. Drabble, Therese Hesketh, Zelee Hill, Joanna Morrison, Oliver Mweemba, David Osrin, Audrey Prost, Janet Seeley, Maryam Shahmanesh, Esther J. Spindler, Erin Stern, Katrina M. Turner, Jenevieve Mannell
Therapeutic drug monitoring-based dose optimisation of piperacillin/tazobactam to improve outcome in patients with sepsis (TARGET): a prospective, multi-centre, randomised controlled trial
Stefan Hagel, Sandra Fiedler, Andreas Hohn, Alexander Brinkmann, Otto R. Frey, Heike Hoyer, Peter Schlattmann, Michael Kiehntopf, Jason A. Roberts, Mathias W. Pletz, Frank Bloos, Stefan Angermair, Hendrik Bracht, Eberhard Barth, Stefan Kluge, Axel Nierhaus, Johann Motsch, Thorsten Brenner, Thorsten Annecke, Friedhelm Bach, Markus Weigand, Markus Schappacher, Andreas von Ameln-Mayerhofer, Guido Michels, Anka Roehr, Thomas Fuchs, Sarah Eichner, Christina Köng, Nadine Pinder, Carsten Müller, Miriam Petersen, Peter Schlattmann, Gerald Steinbach, Dominik Jarczak, Dirk Weisman, Max Kurlbaum, Anke Braune
Intravenous immunoglobulin and rituximab versus placebo treatment of antibody-associated psychosis: study protocol of a randomised phase IIa double-blinded placebo-controlled trial (SINAPPS2)
Belinda Lennox, Ksenija Yeeles, Peter B. Jones, Michael Zandi, Eileen Joyce, Ly-Mee Yu, Giuliano Tomei, Rebecca Pollard, Sally-Anne Vincent, Mio Shimazaki, Iona Cairns, Francis Dowling, Thomas Kabir, Thomas R. E. Barnes, Anne Lingford Hughes, Akram A. Hosseini, Timothy Harrower, Camilla Buckley, Alasdair Coles
Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial
Joerg Kaiser, Willem Niesen, Pascal Probst, Thomas Bruckner, Colette Doerr-Harim, Oliver Strobel, Phillip Knebel, Markus K. Diener, André L. Mihaljevic, Markus W. Büchler, Thilo Hackert
Home-based virtual reality training after discharge from hospital-based stroke rehabilitation: a parallel randomized feasibility trial
Lisa Sheehy, Anne Taillon-Hobson, Heidi Sveistrup, Martin Bilodeau, Christine Yang, Vivian Welch, Alomgir Hossain, Hillel Finestone
Synthesizing existing evidence to design future trials: survey of methodologists from European institutions
Adriani Nikolakopoulou, Sven Trelle, Alex J. Sutton, Matthias Egger, Georgia Salanti
A prospective, multicenter, randomized OCT study of early neointimal condition at first and second months after BuMA Supreme stent versus XIENCE stent implantation in high-bleeding-risk coronary artery disease patients: study protocol for a randomized controlled trial
Bo Li, Qin Hua Jin, Yun Dai Chen, Chang Qian Wang, Bei Shi, Xi Su, Guo Sheng Fu, Yan Qing Wu, Xu Chen Zhou, Zu Yi Yuan
Effect of high-flow nasal therapy during exercise training in COPD patients with chronic respiratory failure: study protocol for a randomised controlled trial
Michele Vitacca, Irene Pietta, Marta Lazzeri, Mara Paneroni
Evaluating the effectiveness and cost-effectiveness of the Smoking Treatment Optimisation in Pharmacies (STOP) intervention: protocol for a cluster randomised controlled trial
Ratna Sohanpal, Sandra Jumbe, Wai-Yee James, Liz Steed, Tammy Yau, Carol Rivas, Vichithranie Madurasinghe, Colin Houlihan, Vlad Berdunisov, Matthew Taylor, Stephanie J. C. Taylor, Chris Griffiths, Sandra Eldridge, Robert Walton
Efficacy of an Internet-based intervention for job stress and burnout among medical professionals: study protocol for a randomized controlled trial
Ewelina Smoktunowicz, Magdalena Lesnierowska, Roman Cieslak, Per Carlbring, Gerhard Andersson
RADIATE – Radial Dysplasia Assessment, Treatment and Aetiology: protocol for the development of a core outcome set using a Delphi survey
George R. F. Murphy, Malcolm Logan, Gill Smith, Bran Sivakumar
A factorial randomised controlled trial to identify efficacious self-regulation techniques in an e- and m-health intervention to target an active lifestyle: study protocol
Helene Schroé, Celien Van der Mispel, Ilse De Bourdeaudhuij, Maïté Verloigne, Louise Poppe, Geert Crombez
Optimal management of HIV- positive adults at risk for kidney disease in Nigeria (Renal Risk Reduction “R3” Trial): protocol and study design
Muktar H. Aliyu, Usman J. Wudil, Donna J. Ingles, Bryan E. Shepherd, Wu Gong, Baba M. Musa, Hamza Muhammad, Mahmoud U. Sani, Aliyu Abdu, Aisha M. Nalado, Akinfenwa Atanda, Aima A. Ahonkhai, Talat A. Ikizler, Cheryl A. Winkler, Jeffrey B. Kopp, Paul L. Kimmel, C. William Wester
The effect of implementing an aseptic practice bundle for anaesthetists to reduce postoperative infections, the Anaesthetists Be Cleaner (ABC) study: protocol for a stepped wedge, cluster randomised, multi-site trial
Alan F. Merry, Derryn A. Gargiulo, Ian Bissett, David Cumin, Kerry English, Christopher Frampton, Richard Hamblin, Jacqueline Hannam, Matthew Moore, Papaarangi Reid, Sally Roberts, Elsa Taylor, Simon J. Mitchell, Ian Chapman, Tim Denison, Lara Hopley, Laura Jackson, Rachael Jones, Cornelius Kruger, Helen Lindsay, Andrew Love, Shay McGuinness, Paget Milsom, Jacob Munro, Guido Panduri, Rocco Pitto, Janie Sheridan, Navdeep Sidhu, Francois Stapelberg, Colin Sweetman, Jane Torrie, Stuart Walker, Christine Walsh, Tim Willcox, Siouxsie Wiles, Simon Young
Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial
Xu Zhou, Dong-mei Yan, Wei-feng Zhu, Wen-jun Liu, He-yun Nie, Sheng Xu, Yi-ping Jiang, Kun-he Zhang, Ying Fu, Yi-ye Wan, Xin-yu Yu, Hong Li, Xin Sun, Xiao-fan Chen
Design paper of the “Blood pressure targets in post-resuscitation care and bedside monitoring of cerebral energy state: a randomized clinical trial”
Simon Mölström, Troels Halfeld Nielsen, Carl H. Nordström, Christian Hassager, Jacob Eifer Møller, Jesper Kjærgaard, Sören Möller, Henrik Schmidt, Palle Toft
Efficacy of Cognition Support Formula® on cognitive function in older adults with subjective cognitive impairment: a protocol for a 26-week, randomised, double-blind, placebo-controlled trial
Adele E. Cave, Dennis H. Chang, Gerald W. Münch, Genevieve Z. Steiner
Robotic-assisted Esophagectomy vs Video-Assisted Thoracoscopic Esophagectomy (REVATE): study protocol for a randomized controlled trial
Yin-Kai Chao, Zhi-Gang Li, Yu-Wen Wen, Dae-Joon Kim, Seong-Yong Park, Yu-Ling Chang, Pieter C. van der Sluis, Jelle P. Ruurda, Richard van Hillegersberg
Efficacy of transcranial direct current stimulation in reducing impulsivity in borderline personality disorder (TIMBER): study protocol of a randomized controlled clinical trial
Juliana Teti Mayer, Magali Nicolier, Damien Gabriel, Caroline Masse, Julie Giustiniani, Charline Compagne, Pierre Vandel, Lionel Pazart, Emmanuel Haffen, Djamila Bennabi
Understanding the impact of a multispecialty electronic consultation service on family physician referral rates to specialists: a randomized controlled trial using health administrative data
Clare Liddy, Isabella Moroz, Erin Keely, Monica Taljaard, Catherine Deri Armstrong, Amir Afkham, Claire E. Kendall
Antithrombin supplementation during extracorporeal membrane oxygenation: study protocol for a pilot randomized clinical trial
Mauro Panigada, Elena Spinelli, Alberto Cucino, Elisa Cipriani, Stefano De Falco, Giovanna Panarello, Giovanna Occhipinti, Antonio Arcadipane, Gabriele Sales, Vito Fanelli, Luca Brazzi, Cristina Novembrino, Dario Consonni, Antonio Pesenti, Giacomo Grasselli
Oleogel-S10 Phase 3 study “EASE” for epidermolysis bullosa: study design and rationale
Johannes S. Kern, Agnes Schwieger-Briel, Sandra Löwe, Mark Sumeray, Charles Davis, Anna E. Martinez
A realist process evaluation of Enhanced Triple P for Baby and Mellow Bumps, within a Trial of Healthy Relationship Initiatives for the Very Early years (THRIVE): study protocol for a randomized controlled trial
Rosaleen O’Brien, Katie Buston, Daniel Wight, Elizabeth McGee, Jane White, Marion Henderson
The acute effects of aerobic exercise on sleep in patients with depression: study protocol for a randomized controlled trial
Gavin Brupbacher, Doris Straus, Hildburg Porschke, Thea Zander-Schellenberg, Markus Gerber, Roland von Känel, Arno Schmidt-Trucksäss
CASSETTE—clindamycin adjunctive therapy for severe Staphylococcus aureus treatment evaluation: study protocol for a randomised controlled trial
Ravindra Dotel, Steven Y. C. Tong, Asha Bowen, Jane N. Nelson, Matthew V. N. O’Sullivan, Anita J. Campbell, Brendan J. McMullan, Philip N. Britton, Joshua R. Francis, Damon P. Eisen, Owen Robinson, Laurens Manning, Joshua S. Davis
Trial management: we need a cadre of high-class triallists to deliver the answers that patients need
Danielle Beaumont, Monica Arribas, Lauren Frimley, Eni Balogun, Ian Roberts, Haleema Shakur-Still
Advancing Symptom Alleviation with Palliative Treatment (ADAPT) trial to improve quality of life: a study protocol for a randomized clinical trial
Bridget A. Graney, David H. Au, Anna E. Barón, Andrew Cheng, Sara A. Combs, Thomas J. Glorioso, Grady Paden, Elizabeth C. Parsons, Borsika A. Rabin, Debra P. Ritzwoller, Jessica-Jean Stonecipher, Carolyn Turvey, Carolyn H. Welsh, David B. Bekelman
Laparoscopic versus open distal pancreatectomy (LAPOP): study protocol for a single center, nonblinded, randomized controlled trial
Bergthor Björnsson, Per Sandström, Anna Lindhoff Larsson, Claes Hjalmarsson, Thomas Gasslander
Hypertonic saline for fluid resuscitation after cardiac surgery (HERACLES): study protocol for a preliminary randomised controlled clinical trial
Carmen A. Pfortmueller, Anna S. Messmer, Benjamin Hess, David Reineke, Laura Jakob, Stefanie Wenger, Jan Waskowski, Patrick Zuercher, Frederik Stoehr, Gabor Erdoes, Markus M. Luedi, Stephan M. Jakob, Lars Englberger, Joerg C. Schefold
Auricular acupressure as a complementary therapy for psoriasis vulgaris: study protocol for a multicenter randomized controlled trial
Jingwen Deng, Chuanjian Lu, Yu Xiang, Hao Deng, Zehuai Wen, Danni Yao, Meiling Xuan, Yuhong Yan
Comparison of two metaphyseal-fitting (short) femoral stems in primary total hip arthroplasty: study protocol for a prospective randomized clinical trial with additional biomechanical testing and finite element analysis
I. Tatani, A. Panagopoulos, I. Diamantakos, G. Sakellaropoulos, Sp Pantelakis, P. Megas
The randomization-induced risk of a trial failing to attain its target power: assessment and mitigation
Hubert Wong, Yongdong Ouyang, Mohammad Ehsanul Karim
iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy
Wesley de Jong, Joeri Aerts, Sabine Allard, Christian Brander, Jozefien Buyze, Eric Florence, Eric van Gorp, Guido Vanham, Lorna Leal, Beatriz Mothe, Kris Thielemans, Montse Plana, Félipe Garcia, Rob Gruters, F. G., José M. Gatell, Joan-Albert Arnaiz, M. P., L. L., Albert Guardo, Maria José Maleno, G. V., E. F., Pieter Pannus, J. B., Leo Heyndrickx, K. T., Joeri Aerts, S. A., Patrick Tjok, C. B., B. M., J. Martinez-Picado, Alex Olvera, Miriam Rosas, Maria Salgado, Sara Moron, Jose Moltó, Miriam López, R. G., Marion Koopmans, W. J., Patrick Boers, Rachel Scheuer, Cynthia Lungu, Carlo Heirman, Sonja Van Meirvenne, Anna Graupera, Ángel Honrado
Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial
Alvaro Casas-Herrero, Ivan Anton-Rodrigo, Fabricio Zambom-Ferraresi, Mikel L. Sáez de Asteasu, Nicolás Martinez-Velilla, Jaione Elexpuru-Estomba, Itxaso Marin-Epelde, Fernanda Ramon-Espinoza, Roberto Petidier-Torregrosa, Juan L. Sanchez-Sanchez, Berta Ibañez, Mikel Izquierdo
Efficacy of surgical excision and sub-dermal injection of triamcinolone acetonide for treatment of keloid scars after caesarean section: a single blind randomised controlled trial protocol
Seng Chai Chua, Beata Gidaszewski, Marjan Khajehei
Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial
Cornelia Straßner, Eckhard Frick, Gabriele Stotz-Ingenlath, Nicola Buhlinger-Göpfarth, Joachim Szecsenyi, Johannes Krisam, Friederike Schalhorn, Jan Valentini, Regina Stolz, Stefanie Joos
Intensive insulin therapy versus plasmapheresis in the management of hypertriglyceridemia-induced acute pancreatitis (Bi-TPAI trial): study protocol for a randomized controlled trial
Xiao Song, Di Shi, Qinghong Cui, Shanshan Yu, Jing Yang, Priscilla Song, Joseph Walline, Jun Xu, Huadong Zhu, Xuezhong Yu
Recruitment of men to a multi-centre diabetes prevention trial: an evaluation of traditional and online promotional strategies
Karen Bracken, Wendy Hague, Anthony Keech, Ann Conway, David J. Handelsman, Mathis Grossmann, David Jesudason, Bronwyn Stuckey, Bu B. Yeap, Warrick Inder, Carolyn Allan, Robert McLachlan, Kristy P. Robledo, Gary Wittert
The impact of lifestyle Physical Activity Counselling in IN-PATients with major depressive disorders on physical activity, cardiorespiratory fitness, depression, and cardiovascular health risk markers: study protocol for a randomized controlled trial
Markus Gerber, Johannes Beck, Serge Brand, Robyn Cody, Lars Donath, Anne Eckert, Oliver Faude, Xenia Fischer, Martin Hatzinger, Edith Holsboer-Trachsler, Christian Imboden, Undine Lang, Sarah Mans, Thorsten Mikoteit, Anja Oswald, Uwe Pühse, Sofia Rey, Ann-Katrin Schreiner, Nina Schweinfurth, Ursula Spitzer, Lukas Zahner
Correction to: Gabapentin as add-on to morphine for severe neuropathic or mixed pain in children from age 3 months to 18 years - evaluation of the safety, pharmacokinetics, and efficacy of a new gabapentin liquid formulation: study protocol for a randomized controlled trial
Thomas G. de Leeuw, Laura Mangiarini, Rebecca Lundin, Florentia Kaguelidou, Tjitske van der Zanden, Oscar Della Pasqua, Dick Tibboel, Adriana Ceci, Saskia N. de Wildt
Effects of immersive virtual reality intervention on pain and anxiety among pediatric patients undergoing venipuncture: a study protocol for a randomized controlled trial
Cho Lee Wong, Miranda Mei Wa Lui, Kai Chow Choi
Hybrid thoracoscopic surgical and transvenous catheter ablation versus transvenous catheter ablation in persistent and longstanding persistent atrial fibrillation (HARTCAP-AF): study protocol for a randomized trial
Mindy Vroomen, Mark La Meir, Bart Maesen, Justin G. L. Luermans, Kevin Vernooy, Brigitte Essers, Bianca T. A. de Greef, Jos G. Maessen, Harry J. Crijns, Laurent Pison
PRevention of INCisional hernia after liver transplantation (PRINC trial): study protocol for a randomized controlled trial
Daniela Kniepeiss, James Elvis Waha, Thomas Auer, Andrea Berghold, Peter Schemmer
Impact of acupuncture for allergic rhinitis on the activity of the hypothalamus-pituitary-adrenal axis: study protocol for a randomized controlled trial
Sheng Chen, Shu-Han Qu, Yi Zhang, Zhi-Hong Wen, Sheng-Nan Guo, Wei-Mei Zeng, Xue-Si Hou, Yi-Fan Jia, Yi Xiao, Federico Marmori, Jun Wang, Ji-Ping Zhao
Comparing theory and non-theory based implementation approaches to improving referral practices in cancer genetics: a cluster randomised trial protocol
April Morrow, Emily Hogden, Yoon-Jung Kang, Julia Steinberg, Karen Canfell, Michael J. Solomon, James G. Kench, Anthony J. Gill, Tim Shaw, Nicholas Pachter, Bonny Parkinson, Luke Wolfenden, Gillian Mitchell, Finlay Macrae, Kathy Tucker, Natalie Taylor
Empagliflozin in heart failure patients with reduced ejection fraction: a randomized clinical trial (Empire HF)
Jesper Jensen, Massar Omar, Caroline Kistorp, Mikael Kjær Poulsen, Christian Tuxen, Ida Gustafsson, Lars Køber, Finn Gustafsson, Emil Fosbøl, Niels Eske Bruun, Lars Videbæk, Peter Hartmund Frederiksen, Jacob Eifer Møller, Morten Schou
PRODIG (Prevention of new onset diabetes after transplantation by a short term treatment of Vildagliptin in the early renal post-transplant period) study: study protocol for a randomized controlled study
E. Gaiffe, T. Crepin, J. Bamoulid, C. Courivaud, M. Büchler, E. Cassuto, L. Albano, J. M. Chemouny, G. Choukroun, M. Hazzan, L. Kessler, C. Legendre, Y. Le Meur, N. Ouali, A. Thierry, A. Anota, V. Nerich, S. Limat, F. Bonnetain, D. Vernerey, D. Ducloux
Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial
Susan Atuhairwe, Josaphat Byamugisha, Marie Klingberg-Allvin, Amanda Cleeve, Claudia Hanson, Nazarius Mbona Tumwesigye, Othman Kakaire, Kristina Gemzell Danielsson
Study on efficacy and safety of Tong-luo Qu-tong plaster treatment for knee osteoarthritis: study protocol for a randomized, double-blind, parallel positive controlled, multi-center clinical trial
Bao-ping Xu, Min Yao, Zi-rui Tian, Long-yun Zhou, Long Yang, Zhen-jun Li, Sen Zhu, Xiao-tao Wang, Jia-hui Lan, Yong-jun Wang, Xue-jun Cui
Some data quality issues at ClinicalTrials.gov
Neha Chaturvedi, Bagish Mehrotra, Sangeeta Kumari, Saurabh Gupta, H. S. Subramanya, Gayatri Saberwal
The effects of probiotic Saccharomyces boulardii on the mental health, quality of life, fatigue, pain, and indices of inflammation and oxidative stress in patients with multiple sclerosis: study protocol for a double-blind randomized controlled clinical trial
Dawood Aghamohammadi, Hormoz Ayromlou, Neda Dolatkhah, Fatemeh Jahanjoo, Seyed Kazem Shakouri
Letter in response to: “Randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with the 12-h regimen of N acetylcysteine for paracetamol overdose—the PP100-01 for Overdose of Paracetamol (POP) trial: study protocol for a randomised controlled trial”
Jan Olof G. Karlsson, Per Jynge, Ingemar Lundström, Louis J. Ignarro
Trials need participants but not their feedback? A scoping review of published papers on the measurement of participant experience of taking part in clinical trials
Claire Planner, Peter Bower, Ailsa Donnelly, K. Gillies, Katrina Turner, Bridget Young
Self-administered acupressure for allergic rhinitis: study protocol for a randomized, single-blind, non-specific controlled, parallel trial
Yaqun Liang, George Binh Lenon, Angela Wei Hong Yang
Multicentre Randomised trial of Acute Stroke treatment in the Ambulance with a nitroglycerin Patch (MR ASAP): study protocol for a randomised controlled trial
Sophie A. van den Berg, Diederik W. J. Dippel, Jeannette Hofmeijer, Puck S. S. Fransen, Klaartje Caminada, Arjen Siegers, Nyika D. Kruyt, Henk Kerkhoff, Frank-Erik de Leeuw, Paul J. Nederkoorn, H. Bart van der Worp
Safety of early oral feeding after total laparoscopic radical gastrectomy for gastric cancer (SOFTLY): Study protocol for a randomized controlled trial
Quan Wang, Bo-Yang Guo, Qing-Chuan Zhao, Zun-Dong Yan, Li-Feng Shang, Juan Yu, Gang Ji
Coping with Uncertainty in Everyday Situations (CUES©) to address intolerance of uncertainty in autistic children: study protocol for an intervention feasibility trial
Jacqui Rodgers, Jane Goodwin, Jeremy R. Parr, Victoria Grahame, Catharine Wright, John Padget, Deborah Garland, Malcolm Osborne, Marie Labus, Ashleigh Kernohan, Mark Freeston
Piloting and evaluating feasibility of a training program to improve patient safety for inter-professional inpatient care teams – study protocol of a cluster randomized controlled trial
Julia Dinius, Antje Hammer, Tanja Manser, Corinna Bergelt, Levente Kriston, Mirjam Körner
Adverse effects of xenogenic scaffolding in the context of a randomized double-blind placebo-controlled study for repairing full-thickness rotator cuff tears
José Ramón Lamas, Carlos García-Fernández, Pilar Tornero-Esteban, Yaiza Lópiz, Luis Rodriguez-Rodriguez, Luis Ortega, Benjamín Fernández-Gutiérrez, Fernando Marco
PULSE-I - Is rePetitive Upper Limb SEnsory stimulation early after stroke feasible and acceptable? A stratified single-blinded randomised controlled feasibility study
Kausik Chatterjee, Rachel C. Stockley, Steven Lane, Caroline Watkins, Katy Cottrell, Brenda Ankers, Sioned Davies, Mary Fisher Morris, Nick Fallon, Turo Nurmikko
Fimasartan versus perindopril with and without diuretics in the treatment of elderly patients with essential hypertension (Fimasartan in the Senior Subjects (FITNESS)): study protocol for a randomized controlled trial
Min-gu Kang, Kwang-il Kim, Sang Hyun Ihm, Moo-Yong Rhee, Il Suk Sohn, Hae-Young Lee, Sungha Park, Eun-Seok Jeon, Jong-Min Song, Wook Bum Pyun, Ki-Chul Sung, Moo Hyun Kim, Sang-Hyun Kim, Seok-Yeon Kim, Shin-Jae Kim, Eung Ju Kim, Jinho Shin, Sung Yun Lee, Kook-Jin Chun, Jin-Ok Jeong, Shung Chull Chae, Ki Dong Yoo, Young Jin Choi, Yong Hwan Park, Cheol-Ho Kim
Do antibacterial skin sutures reduce surgical site infections after elective open abdominal surgery? - Study protocol of a prospective, randomized controlled single center trial
Daniel Matz, Saskia Teuteberg, Andrea Wiencierz, Savas Deniz Soysal, Oleg Heizmann
Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial
Corrado Pedrazzani, Soo Yeun Park, Giovanni Scotton, Jun Seok Park, Hye Jin Kim, Enrico Polati, Alfredo Guglielmi, Gyu Seog Choi
Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial
Amjad Belramman, Roshan Bootun, Tristan R. A. Lane, Alun H. Davies
Inhaled methoxyflurane (Penthrox®) versus placebo for injury-associated analgesia in children—the MAGPIE trial (MEOF-002): study protocol for a randomised controlled trial
Stuart Hartshorn, Michael J. Barrett, Mark D. Lyttle, Sue Anne Yee, Alan T. Irvine
Efficacy of electro-acupuncture and manual acupuncture versus sham acupuncture for knee osteoarthritis: statistical analysis plan for a randomized controlled trial
Jian-Feng Tu, Jing-Wen Yang, Li-Qiong Wang, Yang Wang, Jin-ling Li, Na Zhang, Lu-Lu Lin, Zhang-Sheng Yu, Cun-Zhi Liu
Study protocol for a randomised controlled trial of CBT vs antipsychotics vs both in 14–18-year-olds: Managing Adolescent first episode Psychosis: a feasibility study (MAPS)
Melissa Pyle, Matthew R. Broome, Emmeline Joyce, Graeme MacLennan, John Norrie, Daniel Freeman, David Fowler, Peter M. Haddad, David Shiers, Chris Hollis, Jo Smith, Ashley Liew, Rory E. Byrne, Paul French, Sarah Peters, Jemma Hudson, Linda Davies, Richard Emsley, Alison Yung, Max Birchwood, Eleanor Longden, Anthony P. Morrison
HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya
Katrina F. Ortblad, John E. Kearney, Kenneth Mugwanya, Elizabeth M. Irungu, Jessica E. Haberer, Ruanne V. Barnabas, Deborah Donnell, Nelly Rwamba Mugo, Jared M. Baeten, Kenneth Ngure
Do mobile phone-based reminders and conditional financial transfers improve the timeliness of childhood vaccinations in Tanzania? Study protocol for a quasi-randomized controlled trial
Jan Ostermann, Lavanya Vasudevan, Joy Noel Baumgartner, Esther Ngadaya, Sayoki Godfrey Mfinanga
Hypoglossal acupuncture for acute chemotherapy-induced dysgeusia in patients with breast cancer: study protocol of a randomized, sham-controlled trial
Heidemarie Haller, Taige Wang, Romy Lauche, Kyung-Eun Choi, Petra Voiß, Sabine Felber, Holger Cramer, Beyhan Ataseven, Sherko Kümmel, Anna Paul, Gustav Dobos
Analgesia effect of premixed nitrous oxide/oxygen during the rehabilitation after total knee arthroplasty: a study protocol for a randomized controlled trial
Ya-Liang Dai, Xiao-Min Chai, Ning Zhu, Kai-Bin Wang, Wen-Qiang Bao, Xue-Sen Zhang, Lu-Lu Gao, Qiang Liu, Dong-Mei Bao, Li-Ting Wang, Yi-Ling Wang, Jun-Jun Zhang, Yu-Xiang Li, Jian-Qiang Yu
Preoperative CT versus intraoperative hybrid DynaCT imaging for localization of small pulmonary nodules: a randomized controlled trial
Yin-Kai Chao, Kuang-Tse Pan, Chih-Tsung Wen, Hsin-Yueh Fang, Ming-Ju Hsieh
Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework
Katie Gillies, Marion K. Campbell
Learning to resist the urge: a double-blind, randomized controlled trial investigating alcohol-specific inhibition training in abstinent patients with alcohol use disorder
Raphaela M. Tschuemperlin, Maria Stein, Hallie M. Batschelet, Franz Moggi, Leila M. Soravia
Comparison of effectiveness between warm acupuncture with local-distal points combination and local distribution points combination in breast cancer-related lymphedema patients: a study protocol for a multicenter, randomized, controlled clinical trial
Chien-Hung Yeh, Tian Yi Zhao, Mei Dan Zhao, Yue Wu, Yong Ming Guo, Zhan Yu Pan, Ren Wei Dong, Bo Chen, Bin Wang, Jing Rong Wen, Dan Li, Yi Guo, Xing Fang Pan
Investigating the effect of Eye Movement Desensitization and Reprocessing on pain intensity in patients with primary dysmenorrhea: a protocol for a randomized controlled trial
Sahar Valedi, Zainab Alimoradi, Mohammad MoradiBaglooei, Amir H. Pakpour, Mehdi Ranjbaran, Venus Chegini
Collaborative care for child and youth mental health problems in a middle-income country: study protocol for a randomized controlled trial training general practitioners
Vandad Sharifi, Zahra Shahrivar, Hadi Zarafshan, Sheida Beiky Ashkezary, Elizabeth Stuart, Ramin Mojtabai, Lawrence Wissow
A novel mindful-compassion art therapy (MCAT) for reducing burnout and promoting resilience for end-of-life care professionals: a waitlist RCT protocol
Andy Hau Yan Ho, Geraldine Tan-Ho, Thuy Anh Ngo, Grace Ong, Poh Heng Chong, Dennis Dignadice, Jordan Potash
The effect of a postpartum IUD intervention on counseling and choice: Evidence from a cluster-randomized stepped-wedge trial in Sri Lanka
Mahesh Karra, Erin Pearson, Elina Pradhan, Ranjith de Silva, Arnjali Samarasekera, David Canning, Iqbal Shah, Deepal Weerasekera, Hemantha Senanayake
Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial
Holly G. Prigerson, Martin Viola, Chris R. Brewin, Christopher Cox, Daniel Ouyang, Madeline Rogers, Cynthia X. Pan, Shayna Rabin, Jiehui Xu, Susan Vaughan, Janna S. Gordon-Elliot, David Berlin, Lindsay Lief, Wendy G. Lichtenthal
Effects of neuromuscular training on pain intensity and self-reported functionality for patellofemoral pain syndrome in runners: study protocol for a randomized controlled clinical trial
Haoyu Hu, Yili Zheng, Xiaochen Liu, Di Gong, Changcheng Chen, Yizu Wang, Mengsi Peng, Bao Wu, Juan Wang, Ge Song, Juan Zhang, Jiabao Guo, Yulin Dong, Xueqiang Wang
Ovarian function after the use of various hemostatic techniques during treatment for endometrioma: protocol for a randomized clinical trial
Raquel Silveira da Cunha Araujo, Sabina Bastos Maia, Clara Micalli Ferruzzi Baracat, Moisés Diogo Lima, Eduardo Sérgio Sousa Soares, Helizabet Salomão Abdalla Ayroza Ribeiro, Paulo Augusto Ayroza Galvão Ribeiro
Improved participation of older people with joint contractures living in nursing homes: feasibility of study procedures in a cluster-randomised pilot trial
Susanne Saal, Hanna Klingshirn, Katrin Beutner, Ralf Strobl, Eva Grill, Martin Müller, Gabriele Meyer
Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial
Justin P. Turner, Patricia Caetano, Cara Tannenbaum
Glibenclamide in aneurysmatic subarachnoid hemorrhage (GASH): study protocol for a randomized controlled trial
Bruno Braga Sisnando da Costa, Isabela Costola Windlin, Edwin Koterba, Vitor Nagai Yamaki, Nícollas Nunes Rabelo, Davi Jorge Fontoura Solla, Manoel Jacobsen Teixeira, Eberval Gadelha Figueiredo
Effect of motivational interviewing in hypertensive patients (MIdNIgHT): study protocol for a randomized controlled trial
Luana Claudia Jacoby Silveira, Graziella Badin Aliti, Elisabeth Meyer Da Silva, Ravi Pereira Pimentel, Miguel Gus, Eneida Rejane Rabelo-Silva
To evaluate the efficacy and safety of PLC in perimenopausal or postmenopausal women with Hot Flashes: study protocol for a randomized controlled trial
Su-Ji Choi, Dong-Il Kim
Ensuring trial conduct is consistent with trial design: assumption is the enemy of quality
Joanna Kelly, Barry Hounsome, Gill Lambert, Caroline Murphy
The effect of visual support strategies on the quality of life of children with cerebral palsy and cerebral visual impairment/perceptual visual dysfunction in Nigeria: study protocol for a randomized controlled trial
Roseline Duke, Komomo Eyong, Kathryn Burton, David MacLeod, Gordon N. Dutton, Clare Gilbert, Richard Bowman
Cervicogenic headache treated by acupuncture based on jin theory: study protocol for a randomized controlled trial
Youkang Dong, Taipin Guo, Lei Xu, Chunlin Wang, Guanfen Wen, Zhiyong Zhao, Lianhai Duan, Mei Zou, Yong Xiang, Shu Wang
A clinical study to assess the influence of acupuncture at “Wang’s Jiaji” acupoints on limb spasticity in patients in convalescent stage of ischemic stroke: study protocol for a randomized controlled trial
Huanqin Li, Dehuai Long, Bin Li, Huilin Liu, Tingting Ma, Tingying Wu, Martin Eriksson, Yali Wen, Jia Wei, Wei You, Yinxia Liu, Xiaobai Xu, Yajie Zhang, Linpeng Wang, Jingqing Sun
Combination therapy of vitamin C and thiamine for septic shock in a multicentre, double-blind, randomized, controlled study (ATESS): study protocol for a randomized controlled trial
Sung Yeon Hwang, Jong Eun Park, Ik Joon Jo, Seonwoo Kim, Sung Phil Chung, Taeyoung Kong, Jonghwan Shin, Hui Jai Lee, Kyoung Min You, You Hwan Jo, Doyun Kim, Gil Joon Suh, Taegyun Kim, Won Young Kim, Youn-Jung Kim, Seung Mok Ryoo, Sung-Hyuk Choi, Tae Gun Shin
Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped-wedge cluster-randomised controlled trial
Ann Sarah Walker, Eric Budgell, Magda Laskawiec-Szkonter, Katy Sivyer, Sarah Wordsworth, Jack Quaddy, Marta Santillo, Adele Krusche, Laurence S. J. Roope, Nicole Bright, Fiona Mowbray, Nicola Jones, Kieran Hand, Najib Rahman, Melissa Dobson, Emma Hedley, Derrick Crook, Mike Sharland, Chris Roseveare, F. D. Richard Hobbs, Chris Butler, Louella Vaughan, Susan Hopkins, Lucy Yardley, Timothy E. A. Peto, Martin J. Llewelyn
Enrolling study personnel in Ebola vaccine trials: from guidelines to practice in a non-epidemic context
Edouard Lhomme, Camara Modet, Augustin Augier, Sylvain Faye, Tienhan Sandrine Dabakuyo-Yonli, Claire Levy-Marchal, Eric D’Ortenzio, Yazdan Yazdanpanah, Geneviève Chêne, Abdoul Habib Beavogui, Laura Richert
Acupuncture of different treatment frequency in knee osteoarthritis: a protocol for a pilot randomized clinical trial
Lu-Lu Lin, Jian-Feng Tu, Jia-Kai Shao, Xuan Zou, Tian-Qi Wang, Li-Qiong Wang, Jing-Wen Yang, Ning Sun, Cun-Zhi Liu
Depression in the nursing home: a cluster-randomized stepped-wedge study to probe the effectiveness of a novel case management approach to improve treatment (the DAVOS project)
Valentina A. Tesky, Arthur Schall, Ulrike Schulze, Ulrich Stangier, Frank Oswald, Monika Knopf, Jochem König, Maria Blettner, Elisabeth Arens, Johannes Pantel
Self-injury: Treatment, Assessment, Recovery (STAR): online intervention for adolescent non-suicidal self-injury - study protocol for a randomized controlled trial
Michael Kaess, Julian Koenig, Stephanie Bauer, Markus Moessner, Gloria Fischer-Waldschmidt, Margarete Mattern, Sabine C. Herpertz, Franz Resch, Rebecca Brown, Tina In-Albon, Michael Koelch, Paul L. Plener, Christian Schmahl, Alexandra Edinger
Implementation and effectiveness of evriMED with short messages service (SMS) reminders and tailored feedback compared to standard care on adherence to treatment among tuberculosis patients in Kilimanjaro, Tanzania: proposal for a cluster randomized controlled trial
Marion Sumari-de Boer, Francis M. Pima, Kennedy M. Ngowi, Geoffrey M. Chelangwa, Benson A. Mtesha, Linda M. Minja, Hadija H. Semvua, Stella Mpagama, Blandina T. Mmbaga, Pythia T. Nieuwkerk, Rob E. Aarnoutse
Patient-reported outcome after stemmed versus stemless total shoulder arthroplasty for glenohumeral osteoarthritis: a patient-blinded randomized clinical trial
Zaid Issa, Jeppe Vejlgaard Rasmussen, John Kloth Petersen, Kim Schantz, Stig Brorson
Postoperative complications and nutritional status between uncut Roux-en-Y anastomosis and Billroth II anastomosis after D2 distal gastrectomy: a study protocol for a multicenter randomized controlled trial
Shi Chen, Dong-Wen Chen, Xi-Jie Chen, Yi-Jia Lin, Jun Xiang, Jun Sheng Peng
Arthritis prevention in the pre-clinical phase of RA with abatacept (the APIPPRA study): a multi-centre, randomised, double-blind, parallel-group, placebo-controlled clinical trial protocol
Mariam Al-Laith, Marianna Jasenecova, Sonya Abraham, Aisla Bosworth, Ian N. Bruce, Christopher D. Buckley, Coziana Ciurtin, Maria-Antonietta D’Agostino, Paul Emery, Hill Gaston, John D. Isaacs, Andrew Filer, Benjamin A. Fisher, Thomas W. J. Huizinga, Pauline Ho, Clare Jacklin, Heidi Lempp, Iain B. McInnes, Arthur G. Pratt, Andrew Östor, Karim Raza, Peter C. Taylor, Dirkjan van Schaardenburg, Dharshene Shivapatham, Alison J. Wright, Joana C. Vasconcelos, Joanna Kelly, Caroline Murphy, A. Toby Prevost, Andrew P. Cope
Impact of PReOperative Midazolam on OuTcome of Elderly patients (I-PROMOTE): study protocol for a multicentre randomised controlled trial
Ana Kowark, Rolf Rossaint, András P. Keszei, Petra Bischoff, Michael Czaplik, Berthold Drexler, Peter Kienbaum, Moritz Kretzschmar, Christopher Rex, Thomas Saller, Gerhard Schneider, Martin Soehle, Mark Coburn, Julia Van Waesberghe, Sebastian Ziemann, Anja Winkler, Maria Wittmann, Jonas Hinterberg, Maximilian S. Schaefer, Ulrich Frey, Jens Schreiber, Josef Briegel, Patrick Möhnle, Catharina Zeuzem, Markus Heim, Barbara Kapfer, Stefanie Pilge, Hansjörg Haas, Christopher Rex, Carmen M. Ring, Simone Traub
Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): study protocol for a randomised controlled trial
Juan Carlos Villar, Víctor Mauricio Herrera, Juan Guillermo Pérez Carreño, Eliana Váquiro Herrera, Yeny Zulay Castellanos Domínguez, Skarlet Marcell Vásquez, Zulma Milena Cucunubá, Nilda Graciela Prado, Yolanda Hernández
A dose-ranging, parallel group, split-face, single-blind phase II study of light emitting diode-red light (LED-RL) for skin scarring prevention: study protocol for a randomized controlled trial
Julie K. Nguyen, Jeremy Weedon, Jeannette Jakus, Edward Heilman, R. Rivkah Isseroff, Daniel M. Siegel, Jared R. Jagdeo
Impact of exercise training on cardiotoxicity and cardiac health outcomes in women with breast cancer anthracycline chemotherapy: a study protocol for a randomized controlled trial
Pedro Antunes, Dulce Esteves, Célia Nunes, Francisco Sampaio, António Ascensão, Eduardo Vilela, Madalena Teixeira, Anabela Leal Amarelo, Ana Joaquim
Safety, effectiveness, and economic evaluation of an herbal medicine, Ukgansangajinpibanha granule, in children with autism spectrum disorder: a study protocol for a prospective, multicenter, randomized, double-blinded, placebo-controlled, parallel-group clinical trial
Sun Haeng Lee, Seungwon Shin, Tae-hun Kim, Sang Min Kim, Tae Yoon Do, Sulgi Park, Boram Lee, Hye Jin Shin, Jihong Lee, Jin Yong Lee, Gyu Tae Chang
Executive function training in chronic traumatic brain injury patients: study protocol
Daniel C. Krawczyk, Kihwan Han, David Martinez, Jelena Rakic, Matthew J. Kmiecik, Zhengsi Chang, Linda Nguyen, Michael Lundie, Richard C. Cole, Marielle Nagele, Nyaz Didehbani
A combination of multimodal physical exercises in real and virtual environments for individuals after chronic stroke: study protocol for a randomized controlled trial
Natalia Araujo Mazzini, Murilo Groschitz Ruas Almeida, José Eduardo Pompeu, Janaine Cunha Polese, Camila Torriani-Pasin
Clinical investigation plan for the use of interactive binocular treatment (I-BiT) for the management of anisometropic, strabismic and mixed amblyopia in children aged 3.5–12 years: a randomised controlled trial
Rebecca Brown, Peter Blanchfield, Apostolos Fakis, Paul McGraw, Alexander J. E. Foss
Correction to: Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a steppedwedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART)
Amy E. Maxwell, Martin Dennis, Anthony Rudd, Christopher J. Weir, Richard A. Parker, Rustam Al-Shahi Salman
Microenterprise intervention to reduce sexual risk behaviors and increase employment and HIV preventive practices in economically-vulnerable African-American young adults (EMERGE): protocol for a feasibility randomized clinical trial
Larissa Jennings Mayo-Wilson, Nancy E. Glass, Fred M. Ssewamala, Sebastian Linnemayr, Jessica Coleman, Fatmata Timbo, Matthew W. Johnson, Melissa Davoust, Alain Labrique, Gayane Yenokyan, Brian Dodge, Carl Latkin
Probiotics in pregnancy: protocol of a double-blind randomized controlled pilot trial for pregnant women with depression and anxiety (PIP pilot trial)
Pamela D. Browne, Antoinette Bolte, Eric Claassen, Carolina de Weerth
A prospective randomized double-blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24h morphine consumption after posterior lumbar inter-body fusion surgery
M. B. Breebaart, D. Van Aken, O. De Fré, L. Sermeus, N. Kamerling, L. de Jong, J. Michielsen, E. Roelant, V. Saldien, B. Versyck
Prevention of Morbidity in Sickle Cell Disease (POMS2a)—overnight auto-adjusting continuous positive airway pressure compared with nocturnal oxygen therapy: a randomised crossover pilot study examining patient preference and safety in adults and children
Jo Howard, Sophie A. Lee, Baba Inusa, Man Ying Edith Cheng, Cheema Bavenjit, Isabel C. Reading, Sally Ann Wakeford, Johanna C. Gavlak, Patrick B. Murphy, Nicholas Hart, Atul Gupta, Sati Sahota, Eufemia Jacob, Maria Chorozoglou, Carol Ossai, Maureen Gwam, Fenella J. Kirkham, Angela M. Wade, Christina Liossi
Protocol for a randomized clinical trial exploring the effect of antimicrobial agents on the penile microbiota, immunology and HIV susceptibility of Ugandan men
Ronald M. Galiwango, Bernard Bagaya, Juliet Mpendo, Vineet Joag, Brenda Okech, Annet Nanvubya, Ali Ssetaala, Moses Muwanga, Rupert Kaul
Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial
Nicolas J. Pejovic, Susanna Myrnerts Höök, Josaphat Byamugisha, Tobias Alfvén, Clare Lubulwa, Francesco Cavallin, Jolly Nankunda, Hege Ersdal, Giulia Segafredo, Mats Blennow, Daniele Trevisanuto, Thorkild Tylleskär
Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial
Chan-Yung Jung, Min-Jin Cho, Ha-Ra Kang, Seung-Ug Hong, Won-Suk Sung, Eun-Jung Kim
Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial
Jian Lyu, Yan-ming Xie, Zhan Gao, Jian-wu Shen, Yue-yi Deng, Song-tao Xiang, Wen-xi Gao, Wen-tong Zeng, Chun-he Zhang, Dan-hui Yi, Lian-xin Wang, Zhi-fei Wang
Development of the IRIS-AR strategy: an intervention to improve rates of accrual and retention for the VTE-PRO randomized controlled trial
Christine Fahim, Danielle Hylton, Marko Simunovic, John Agzarian, Christian Finley, Wael C. Hanna, Yaron Shargall
The effectiveness and safety of Kami Guibi-tang for mild cognitive impairment: study protocol of a pilot, randomized, placebo-controlled, double-blind trial
Hee-Yeon Shin, Jeong-Hwa Kim, Geon-Ho Jahng, Woo-Sang Jung, Seong-Uk Park, Chang-Nam Ko, Jung-Mi Park
Outcomes for Pressure Ulcer Trials (OUTPUTs): protocol for the development of a core domain set for trials evaluating the clinical efficacy or effectiveness of pressure ulcer prevention interventions
Anna Lechner, Jan Kottner, Susanne Coleman, Delia Muir, Heather Bagley, Dimitri Beeckman, Wendy Chaboyer, Janet Cuddigan, Zena Moore, Claudia Rutherford, Jochen Schmitt, Jane Nixon, Katrin Balzer
High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol for a noninferiority randomized clinical trial
Andrea Cortegiani, Federico Longhini, Annalisa Carlucci, Raffaele Scala, Paolo Groff, Andrea Bruni, Eugenio Garofalo, Maria Rita Taliani, Uberto Maccari, Luigi Vetrugno, Enrico Lupia, Giovanni Misseri, Vittoria Comellini, Antonino Giarratano, Stefano Nava, Paolo Navalesi, Cesare Gregoretti
Reducing provider workload while preserving patient safety via a two-way texting intervention in Zimbabwe’s voluntary medical male circumcision program: study protocol for an un-blinded, prospective, non-inferiority, randomized controlled trial
Caryl Feldacker, Vernon Murenje, Scott Barnhart, Sinokuthemba Xaba, Batsirai Makunike-Chikwinya, Isaac Holeman, Mufuta Tshimanga
Brushing RemInder 4 Good oral HealTh (BRIGHT) trial: does an SMS behaviour change programme with a classroom-based session improve the oral health of young people living in deprived areas? A study protocol of a randomised controlled trial
Zoe Marshman, Hannah Ainsworth, Ivor Gordon Chestnutt, Peter Day, Donna Dey, Sarab El Yousfi, Caroline Fairhurst, Fiona Gilchrist, Catherine Hewitt, Claire Jones, Ian Kellar, Sue Pavitt, Mark Robertson, Sarwat Shah, Katherine Stevens, David Torgerson, Nicola Innes
Improving recruitment to a study of telehealth management for COPD: a cluster randomised controlled ‘study within a trial’ (SWAT) of a multimedia information resource
Kate Jolly, Manbinder Sidhu, Peter Bower, Vichithranie Madurasinghe, Sandra Eldridge, Jonathan Graffy, Adwoa Parker, Peter Knapp, David Torgerson, Shaun Treweek
Clinical efficacy of different marginal forms of endocrowns: study protocol for a randomized controlled trial
Jieli Sun, Wenhao Ruan, Jiahui He, Xiaoyu Lin, Bowen Ci, Siye Yin, Wenjuan Yan
The effect of a single 4CMenB vaccine booster in young people more than ten years after infant immunisation: protocol of an exploratory immunogenicity study
Kimberly Davis, Karen Ford, Rachel Craik, Ushma Galal, Christine S. Rollier, Andrew J. Pollard
Repetitive vascular occlusion stimulus (RVOS) versus standard care to prevent muscle wasting in critically ill patients (ROSProx):a study protocol for a pilot randomised controlled trial
Ismita Chhetri, Julie E. A. Hunt, Jeewaka R. Mendis, Stephen D. Patterson, Zudin A. Puthucheary, Hugh E. Montgomery, Benedict C. Creagh-Brown
ImPROving TB outcomes by modifying LIFE-style behaviours through a brief motivational intervention followed by short text messages (ProLife): study protocol for a randomised controlled trial
Andrew Stephen Moriarty, Goedele Maria Louwagie, Noreen Dadirai Mdege, Neo Morojele, John Tumbo, Olufemi Babatunde Omole, Max Oscar Bachmann, Mona Kanaan, Astrid Turner, Steve Parrott, Kamran Siddiqi, Olalekan Abdulwahab Ayo-Yusuf
Nocebo effects of a simplified package leaflet compared to unstandardised oral information and a standard package leaflet: a pilot randomised controlled trial
Barbara Prediger, Esther Meyer, Roland Büchter, Tim Mathes
Aspirin versus placebo for the treatment of venous leg ulcers—a phase II, pilot, randomised trial (AVURT)
Tilbrook Helen, Cook Liz, Clark Laura, Sbizzera Illary, Bland Martin, Buckley Hannah, Chetter Ian, Dumville Jo, Fenner Chris, Forsythe Rachael, Gabe Rhian, Harding Keith, Layton Alison, Lindsay Ellie, Mc Daid Catriona, Moffatt Christine, Rolfe Debbie, Stansby Gerard, Torgerson David, Vowden Peter, Williams Laurie, Hinchliffe Robert
Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia
Dibyadyuti Datta, Ruth Namazzi, Andrea L. Conroy, Sarah E. Cusick, Heather A. Hume, Abner Tagoola, Russell E. Ware, Robert O. Opoka, Chandy C. John
Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial
L. Nibali, V. Koidou, S. Salomone, T. Hamborg, R. Allaker, R. Ezra, L. Zou, G. Tsakos, N. Gkranias, N. Donos
The use and protective effects of transcutaneous electrical acupoint stimulation during abdominal surgery: study protocol for a multicenter randomized parallel controlled trial
Yuantao Hou, Qi Yan, Haiyan An, Junlu Wang, Ming Tian, Wensheng Zhao, Anshi Wu, Yi Feng
PROCalcitonin-based algorithm for antibiotic use in Acute Pancreatitis (PROCAP): study protocol for a randomised controlled trial
Ajith K. Siriwardena, Santhalingam Jegatheeswaran, James M. Mason, Minas Baltatzis, Anthony Chan, Aali J. Sheen, Derek O’Reilly, Saurabh Jamdar, Rahul Deshpande, Nicola de Liguori Carino, Thomas Satyadas, Ahmed Qamruddin, Katharine Hayden, Michael J. Parker, John Butler, Azita Rajai, Ben McIntyre
Food 4 Health - He Oranga Kai: Assessing the efficacy, acceptability and economic implications of Lactobacillus rhamnosus HN001 and β-glucan to improve glycated haemoglobin, metabolic health, and general well-being in adults with pre-diabetes: study protocol for a 2 × 2 factorial design, parallel group, placebo-controlled randomized controlled trial, with embedded qualitative study and economic analysis
Christine Barthow, Fiona Hood, Eileen McKinlay, Jo Hilder, Christine Cleghorn, Mark Huthwaite, Mark Weatherall, Amber Parry-Strong, Sue Pullon, Ben Gray, Kristin Wickens, Julian Crane, Jeremy Krebs
Extracorporeal carbon dioxide removal for acute hypercapnic exacerbations of chronic obstructive pulmonary disease: study protocol for a randomised controlled trial
Nicholas A. Barrett, Eirini Kostakou, Nicholas Hart, Abdel Douiri, Luigi Camporota
Utilizing a low-carbohydrate/high-protein diet to improve metabolic health in individuals with spinal cord injury (DISH): study protocol for a randomized controlled trial
Ceren Yarar-Fisher, Jia Li, Amie McLain, Barbara Gower, Robert Oster, Casey Morrow
Tranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial
Amy Brenner, Adefemi Afolabi, Syed Masroor Ahmad, Monica Arribas, Rizwana Chaudhri, Timothy Coats, Jack Cuzick, Ian Gilmore, Christopher Hawkey, Vipul Jairath, Kiran Javaid, Aasia Kayani, Muttiullah Mutti, Muhammad Arif Nadeem, Haleema Shakur-Still, Simon Stanworth, Andrew Veitch, Ian Roberts
A randomized clinical trial on the effects of bupropion and buprenorphine on the reduction of methamphetamine craving
Jamshid Ahmadi, Ali Sahraian, Mehdi Biuseh
The redox-dependent regulation of satellite cells following aseptic muscle trauma (SpEED): study protocol for a randomized controlled trial
Konstantinos Papanikolaou, Dimitrios Draganidis, Athanasios Chatzinikolaou, Vassiliki C. Laschou, Kalliopi Georgakouli, Panagiotis Tsimeas, Alexios Batrakoulis, Chariklia K. Deli, Athanasios Z. Jamurtas, Ioannis G. Fatouros
Evaluation of clinical efficacy of silver-needle warm acupuncture in treating adults with acute low back pain due to lumbosacral disc herniation: study protocol for a randomized controlled trial
Tian Li, Siyao Wang, Shen Zhang, Xueyong Shen, Yanwen Song, Zhen Yang, Zouqin Huang
Sequential dual-site High-Definition transcranial Direct Current Stimulation (HD-tDCS) treatment in chronic subjective tinnitus: study protocol of a double-blind, randomized, placebo-controlled trial
E. Cardon, V. Van Rompaey, L. Jacquemin, G. Mertens, H. Vermeersch, I. Joossen, J. Beyers, O. M. Vanderveken, P. Van de Heyning, V. Topsakal, A. Gilles
A pragmatic effectiveness randomized controlled trial of the duration of psychiatric hospitalization in a trans-diagnostic sample of patients with acute mental illness admitted to a ward with either blue-depleted evening lighting or normal lighting conditions
Jan Scott, Knut Langsrud, Daniel Vethe, Kaia Kjørstad, Cecilie L. Vestergaard, Patrick Faaland, Stian Lydersen, Arne Vaaler, Gunnar Morken, Terje Torgersen, Håvard Kallestad
Condom use to enhance regression of cervical intraepithelial neoplasia: study protocol for a randomized controlled trial
Malene Skorstengaard, Julie Suhr, Elsebeth Lynge
Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK
Victoria Shepherd, Fiona Wood, Richard Griffith, Mark Sheehan, Kerenza Hood
A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral Shaft Fracture FIXation (HU-FIX) Study protocol
William M. Oliver, Thomas H. Carter, Catriona Graham, Timothy O. White, Nicholas D. Clement, Andrew D. Duckworth, Samuel G. Molyneux
Update to the study protocol, including statistical analysis plan, for the multicentre, randomised controlled OuTSMART trial: a combined screening/treatment programme to prevent premature failure of renal transplants due to chronic rejection in patients with HLA antibodies
Dominic Stringer, Leanne M. Gardner, Janet L. Peacock, Irene Rebollo-Mesa, Rachel Hilton, Olivia Shaw, Richard Baker, Brendan Clark, Raj C. Thuraisingham, Matthew Buckland, Michael Picton, Judith Worthington, Richard Borrows, David Briggs, Sapna Shah, Kin Yee Shiu, Keith McCullough, Mysore Phanish, Janet Hegarty, John Stoves, Aimun Ahmed, Waqar Ayub, Robert Horne, Paul McCrone, Joanna Kelly, Caroline Murphy, Anthony Dorling
Whole brain radiotherapy (WBRT) after local treatment of brain metastases in melanoma patients: Statistical Analysis Plan
Serigne N. Lo, Angela M. Hong, Lauren E. Haydu, Tasnia Ahmed, Elizabeth J. Paton, Victoria Steel, George Hruby, Anh Tran, Rachael L. Morton, Anna K. Nowak, Janette L. Vardy, Katharine J. Drummond, Haryana M. Dhillon, Catherine Mandel, Richard A. Scolyer, Mark R. Middleton, Bryan H. Burmeister, John F. Thompson, Gerald B. Fogarty
Effects of electroacupuncture combined with computer-based cognitive rehabilitation on mild cognitive impairment: study protocol for a pilot randomized controlled trial
Jae-Hong Kim, Jae-Young Han, Gwang-Cheon Park, Jeong-Soon Lee
The influence of timing of Maternal administration of Antibiotics during cesarean section on the intestinal Microbial colonization in Infants (MAMI-trial): study protocol for a randomised controlled trial
Thomas H. Dierikx, Daniel J. C. Berkhout, Laura Visser, Marc A. Benninga, Guus Roeselers, Nanne K. H. de Boer, Johanna I. P. de Vries, Tim G. J. de Meij
Efficacy and safety of electroacupuncture plus warm needling therapy for heel pain: study protocol for a randomized controlled trial
Lai Fun Ho, Yuanqi Guo, Jessica Yuet-Ling Ching, Kam Leung Chan, Ping Him Tsang, Man Hin Wong, Liyi Chen, Bacon Fung-Leung Ng, Zhi-Xiu Lin
Yinang formulation versus placebo granules as a treatment for chronic kidney disease stages III–IV in patients with autosomal dominant polycystic kidney disease: study protocol for a double-blind placebo-controlled randomized clinical trial
Jing Gan, Yansheng Wu, Xuezhong Gong, Yiyi Ma, Shengqiang Yu, Jiandong Gao
NA-CONTROL: a study protocol for a randomised controlled trial to compare specific outpatient rehabilitation that targets cerebral mechanisms through relearning motor control and uses self-management strategies to improve functional capability of the upper extremity, to usual care in patients with neuralgic amyotrophy
Renee Lustenhouwer, Nens van Alfen, Ian G. M. Cameron, Ivan Toni, Alexander C. H. Geurts, Rick C. Helmich, Baziel G. M. van Engelen, Jan T. Groothuis
The HOME Study: study protocol for a randomised controlled trial comparing the addition of Proactive Psychological Medicine to usual care, with usual care alone, on the time spent in hospital by older acute hospital inpatients
Jane Walker, Katy Burke, Mark Toynbee, Maike van Niekerk, Chris Frost, Nicholas Magill, Simon Walker, Mark Sculpher, Ian R. White, Michael Sharpe
High-intensity exercise to promote accelerated improvements in cardiorespiratory fitness (HI-PACE): study protocol for a randomized controlled trial
Joshua E. McGee, Savanna G. Barefoot, Nicole R. Gniewek, Patricia M. Brophy, Angela Clark, Gabriel S. Dubis, Terence E. Ryan, Joseph A. Houmard, Paul Vos, Thomas D. Raedeke, Damon L. Swift
Limitations of the incidence density ratio as approximation of the hazard ratio
Ralf Bender, Lars Beckmann
A booklet self-help intervention to reduce depressive symptoms among people living with HIV in Botswana: study protocol for a randomized controlled trial
Boitumelo Vavani, Vivian Kraaij, Phillip Spinhoven, Nadia Garnefski
Manual therapy versus therapeutic exercise in non-specific chronic neck pain: study protocol for a randomized controlled trial
Carlos Bernal-Utrera, Juan José González-Gerez, Manuel Saavedra-Hernandez, Miguel Ángel Lérida-Ortega, Cleofás Rodríguez-Blanco
Impact of pharmacist educational intervention on disease knowledge, rehabilitation and medication adherence, treatment-induced direct cost, health-related quality of life and satisfaction in patients with rheumatoid arthritis: study protocol for a randomized controlled trial
Atta Abbas Naqvi, Mohamed Azmi Hassali, Syed Baqir Shyum Naqvi, Muhammad Tariq Aftab
The efficacy of a cyclin dependent kinase 9 (CDK9) inhibitor, FIT039, on verruca vulgaris: study protocol for a randomized controlled trial
Takashi Nomura, Eriko Sumi, Gyohei Egawa, Saeko Nakajima, Eiko Toichi, Ryuji Uozumi, Harue Tada, Takayuki Nakagawa, Masatoshi Hagiwara, Kenji Kabashima
The efficacy of polyglycolic acid felt reinforcement in preventing postoperative pancreatic fistula after pancreaticojejunostomy in patients with main pancreatic duct less than 3 mm in diameter and soft pancreas undergoing pancreatoduodenectomy (PLANET-PJ trial): study protocol for a multicentre randomized phase III trial in Japan and Korea
Kazuto Shibuya, Jin-Young Jang, Sohei Satoi, Masayuki Sho, Suguru Yamada, Manabu Kawai, Hongbeom Kim, Song Cheol Kim, Jin Seok Heo, Yoo-Seok Yoon, Joon Seong Park, Ho Kyoung Hwang, Isaku Yoshioka, Toshio Shimokawa, Hiroki Yamaue, Tsutomu Fujii
An online intervention for improving stroke survivors’ health-related quality of life: study protocol for a randomised controlled trial
Ashleigh Guillaumier, Sam McCrabb, Neil J. Spratt, Michael Pollack, Amanda L. Baker, Parker Magin, Alyna Turner, Christopher Oldmeadow, Clare Collins, Robin Callister, Chris Levi, Andrew Searles, Simon Deeming, Olivia Wynne, Alexandra M. J. Denham, Brigid Clancy, Billie Bonevski
Facilitating trial recruitment: A qualitative study of patient and staff experiences of an orthopaedic trauma trial
Emma Elizabeth Phelps, Elizabeth Tutton, Xavier Griffin, Janis Baird, Matthew L. Costa, Nicholas Parsons, Melina Dritsaki, May Ee Png, Juul Achten, Robin Lerner, Alwin McGibbon
Progression criteria in trials with an internal pilot: an audit of publicly funded randomised controlled trials
Esther Herbert, Steven A. Julious, Steve Goodacre
Comparative study of the inhibitory effect on bone erosion progression with denosumab treatment and conventional treatment in rheumatoid arthritis patients: study protocol for an open-label randomized controlled trial by HR-pQCT
Naoki Iwamoto, Shuntaro Sato, Remi Sumiyoshi, Ko Chiba, Nanami Miyamoto, Kumiko Arinaga, Makiko Kobayashi, Hiroshi Yamamoto, Makoto Osaki, Atsushi Kawakami
Effectiveness of a home-based re-injury prevention program on motor control, return to sport and recurrence rates after anterior cruciate ligament reconstruction: study protocol for a multicenter, single-blind, randomized controlled trial (PReP)
Daniel Niederer, Matthias Keller, Andrea Achtnich, Ralph Akoto, Atesch Ateschrang, Winfried Banzer, Alexander Barié, Raymond Best, Andree Ellermann, Andreas Fischer, Daniel Guenther, Mirco Herbort, Jürgen Höher, Maren Janko, Tobias M. Jung, Matthias Krause, Wolf Petersen, Thomas Stoffels, Amelie Stöhr, Frederic Welsch, Thomas Stein
The HOSENG trial – Effect of the provision of oral self-testing for absent and refusing individuals during a door-to-door HIV-testing campaign on testing coverage: protocol of a cluster-randomized clinical trial in rural Lesotho
Alain Amstutz, Thabo Ishmael Lejone, Lefu Khesa, Josephine Muhairwe, Bienvenu Lengo Nsakala, Katleho Tlali, Moniek Bresser, Fiona Vanobberghen, Mathebe Kopo, Mpho Kao, Thomas Klimkait, Manuel Battegay, Niklaus Daniel Labhardt, Tracy Renée Glass
Influence of upper-body continuous, resistance or high-intensity interval training (CRIT) on postprandial responses in persons with spinal cord injury: study protocol for a randomised controlled trial
David W. McMillan, Jennifer L. Maher, Kevin A. Jacobs, Armando J. Mendez, Mark S. Nash, James L. J. Bilzon
A central nervous system-focused treatment approach for people with frozen shoulder: protocol for a randomized clinical trial
Enrique Lluch-Girbés, Lirios Dueñas, Silvia Mena-del Horno, Alejandro Luque-Suarez, Santiago Navarro-Ledesma, Adriaan Louw
Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial
Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O’Dowd, James Law, Elizabeth McGee, Daniel Wight, Catherine Nixon, Shona Shinwell, Jane White, Karen Crawford, Rosaleen O’Brien, Caoimhe Clarke, Kathleen Boyd, Alice MacLachlan
Effectiveness of the serious game ‘You & I’ in changing mentalizing abilities of adults with mild to borderline intellectual disabilities: a parallel superiority randomized controlled trial
Suzanne Derks, Suze van Wijngaarden, Mirjam Wouda, Carlo Schuengel, Paula S. Sterkenburg
A phase 1/2 trial to evaluate the pharmacokinetics, safety, and efficacy of NI-03 in patients with chronic pancreatitis: study protocol for a randomized controlled trial on the assessment of camostat treatment in chronic pancreatitis (TACTIC)
Mitchell L. Ramsey, Janet Nuttall, Phil A. Hart
Peek Community Eye Health - mHealth system to increase access and efficiency of eye health services in Trans Nzoia County, Kenya: study protocol for a cluster randomised controlled trial
Hillary Rono, Andrew Bastawrous, David Macleod, Emmanuel Wanjala, Stephen Gichuhi, Matthew Burton
Effects of prophylactic swallowing exercises on dysphagia and quality of life in patients with head and neck cancer receiving (chemo) radiotherapy: the Redyor study, a protocol for a randomized clinical trial
Anna Guillen-Sola, Neus Bofill Soler, Ester Marco, Oscar Pera-Cegarra, Palmira Foro
Regional cerebral oxygen saturation and postoperative delirium in endovascular surgery: a prospective cohort study
Xiaohua Wang, Kunpeng Feng, Haixia Liu, Yanhui Liu, Ming Ye, Guoguang Zhao, Tianlong Wang
Impact of the Umoyo mother-infant pair model on HIV-positive mothers’ social support, perceived stigma and 12-month retention of their HIV-exposed infants in PMTCT care: evidence from a cluster randomized controlled trial in Zambia
Sydney Chauwa Phiri, Sandra Mudhune, Margaret L. Prust, Prudence Haimbe, Hilda Shakwelele, Tina Chisenga, Mwangelwa Mubiana-Mbewe, Maureen Mzumara, Elizabeth McCarthy, Marta R. Prescott
Managing uncertain recovery for patients nearing the end of life in hospital: a mixed-methods feasibility cluster randomised controlled trial of the AMBER care bundle
J. Koffman, E. Yorganci, D. Yi, W. Gao, F. Murtagh, A. Pickles, S. Barclay, H. Johnson, R. Wilson, L. Sampson, J. Droney, M. Farquhar, T. Prevost, C. J. Evans
The World Health Organization ACTION-I (Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns) Trial: a multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries
Rajiv Bahl, A. Metin Gülmezoglu, My Huong Nguyen, Olufemi T. Oladapo, Gilda Piaggio, Joshua P. Vogel, Abdullah H. Baqui, Mohammod Shahidullah, Shivaprasad Goudar, Ashalata A. Mallapur, Shailaja Bidri, Sujata Misra, John Kinuthia, Zahida Qureshi, Frederick Were, Adejumoke Idowu Ayede, Bukola Fawole, Ebunoluwa A. Adejuyigbe, Oluwafemi Kuti, Shabina Ariff, Lumaan Sheikh, Sajid Soofi, James Neilson, Fernando Althabe, Harish Chellani, Elizabeth Molyneux, Kidza Mugerwa, Khalid Yunis, Liana Campodonico, Guillermo Carroli, Hugo Gamerro, Daniel Giordano, My Huong Nguyen, Janna Patterson, Abdullah H. Baqui, Rasheda Khanam, Meagan Harrison, Mohammod Shahidullah, Saleha Begum Chowdhury, Mohammad Abdul Mannan, Begum Nasrin, Salahuddin Ahmed, Nazma Begum, Saima Sultana, Soofia Khatoon, Anjuman Ara, Murshed Ahmed Chowdhury, Probhat Ranjan Dey, Dilip Kumar Bhowmik, Md. Abdus Sabur, Mohammad Tarek Azad, Gulshan Ara, Shaheen Akter, Sumia Bari, Md Mojibur Rahman, Farida Yasmin, M. A. Matin, Shahana Ferdous Choudhury, Shivaprasad S. Goudar, Sangappa M. Dhaded, Mrityunjay C. Metgud, Yeshita V. Pujar, Manjunath S. Somannavar, Sunil S. Vernekar, Veena Herekar, Vishwanath L. Machakanur, Shruti S. Andola, Ashalata A. Mallapur, Geetanjali M. Katageri, Sumangala Math, Bhuvaneshwari C. Yelamali, Ramesh Pol, Umesh Ramdurg, Shailaja R. Bidri, Sangamesh Mathpati, Preeti Patil, Bhavana B. Lakhkar, M. M. Patil, Muttu R. Gudadinni, Sujata S. Misra, Maya Padhi, Leena B. Das, Lucy Das, Saumya S. Nanda, Madhusmita J. Pradhan, Girija Shankar G. Mohanty, Rasmita S. Nayak, Bipsha S. Singh, Zahida Qureshi, Fredrick Were, Alfred Osoti, George Gwako, Ahmed Laving, John Kinuthia, Hafsa Mohamed, Faiza Nassir, Nayarit Mohamed, Adelaide Barassa, Joachim Ogindo, Bernard Gwer, Waweru Salome, Grace Ochieng, Njoroge John Githua, Bernadine Lusweti, Bukola Fawole, Adejumoke Idowu Ayede, Michael Abiola Okunlola, Olubukola A. Adesina, Adegoke Gbadegesin Falade, Oluwakemi Funmilola Ashubu, Olubunmi Busari, Wilfred Sanni, Aloysius Ebedi, Ejinkeonye I. Kate, Odiah Violet, Hadiza Abdulaziz Idris, Fatima Ali Sallau, Okoli Chinyere Viola, Ekwem Lilian Osaretin, Theresa Azonima Irinyenikan, Omolayo Adebukola Olubosede, Olufemi M. Omololu, Olugbenga Runsewe, Zainab Imam, Adesina Lawrence Akintan, Olorunfemi Oludele Owa, Olabanke Rosena Oluwafemi, Ireti Patricia Eniowo, Adetokunbo Fabamwo, Elizabeth Disu, Oluwafemi Kuti, Ibraheem Olayemi Awowole, Adebanjo Babalola Adeyemi, Akintunde Olusegun Fehintola, Ebunoluwa Aderonke Adejuyigbe, Henry Chineme Anyabolu, Bankole Peter Kuti, Olusola Comfort Famurewa, Adedapo Babatunde Anibaba Ande, Ikechukwu Okonkwo, Aboyeji Abiodun Peter, Mokuolu Olugbenga, Omotayo Adesiyun, Anthony Dennis Isah, Olateju Eyinade Kudirat, Olusanya Abiodun, Olabisi Florence Dedeke, Lawal Oyeneyin, Francis Bola Akinkunmi, Shabin Ariff, Lumaan Sheikh, Sajid Bashir Soofi, Nida Najimi, Mubarak Ali, Jamal Anwar, Saima Zulfiqar, Sadia Zulfiqar, Raheel Sikander, Shazia Rani, Salma Sheikh, Shazia Memon
Non-concealed placebo treatment for menopausal hot flushes: Study protocol of a randomized-controlled trial
Yiqi Pan, Ramona Meister, Bernd Löwe, Anne Winkelmann, Ted J. Kaptchuk, Kai J. Buhling, Yvonne Nestoriuc
A randomized controlled trial of an Internet-based intervention for eating disorders and the added value of expert-patient support: study protocol
Pieter J. Rohrbach, Alexandra E. Dingemans, Philip Spinhoven, Elske Van den Akker-Van Marle, Joost R. Van Ginkel, Marjolein Fokkema, Markus Moessner, Stephanie Bauer, Eric F. Van Furth
Efficacy of acetaminophen with and without oxycodone for analgesia in non-operative treatment of extremity fractures in adults: protocol for a double-blind randomized clinical trial
Tao Gao, Hongyi Zhu, Changqing Zhang, Yimin Chai, Cheng Guo, Xiaozhong Zhu, Bingbo Bao, Xingwei Li, Junqing Lin, Xianyou Zheng
Development of a Core Outcome Set and Minimum Reporting Set for intervention studies in growth restriction in the NEwbOrN (COSNEON): study protocol for a Delphi study
Martine Knol, Helena Wang, Frank Bloomfield, Tabitha Piet, Stefanie Damhuis, Asma Khalil, Wessel Ganzevoort, Sanne Gordijn
Effects of oral Nigella sativa oil on the expression levels and serum concentrations of adiponectin, PPAR-γ, and TNF-α in overweight and obese women: a study protocol for a crossover-designed, double-blind, placebo-controlled randomized clinical trial
Elham Razmpoosh, Sara Safi, Mahta Mazaheri, Amin Salehi-Abargouei, Nooshin Abdollahi, Majid Nazari, Hossein Fallahzadeh, Azadeh Nadjarzadeh
Clinical trial data reuse – overcoming complexities in trial design and data sharing
Toby Wilkinson, Siddharth Sinha, Niels Peek, Nophar Geifman
A study protocol for a randomised controlled trial evaluating the effects of intraoperative computed tomography on the outcomes of zygomatic fractures
Andrew Higgins, Michael Hurrell, Richard Harris, Geoffrey Findlay, Michael David, Martin Batstone
A structured telephone-delivered intervention to reduce problem alcohol use (Ready2Change): study protocol for a parallel group randomised controlled trial
Dan I. Lubman, Jasmin Grigg, Victoria Manning, Kate Hall, Isabelle Volpe, Stephanie Dias, Amanda Baker, Petra K. Staiger, John Reynolds, Anthony Harris, Jonathan Tyler, David Best
Correction to: Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): study protocol for a randomised controlled trial
Juan Carlos Villar, Víctor Mauricio Herrera, Juan Guillermo Pérez Carreño, Eliana Váquiro Herrera, Yeny Zulay Castellanos Domínguez, Skarlet Marcell Vásquez, Zulma Milena Cucunubá, Nilda Graciela Prado, Yolanda Hernández
Treatment of irritable bowel syndrome with diarrhoea using titrated ondansetron (TRITON): study protocol for a randomised controlled trial
David Gunn, Ron Fried, Rabia Lalani, Amanda Farrin, Ivana Holloway, Tom Morris, Catherine Olivier, Rachael Kearns, Maura Corsetti, Mark Scott, Adam Farmer, Anton Emmanuel, Peter Whorwell, Yan Yiannakou, David Sanders, John Mclaughlin, Kapil Kapur, Maria Eugenicos, Ayesha Akbar, Nigel Trudgill, Lesley Houghton, Phil G. Dinning, Alexander C. Ford, Qasim Aziz, Robin Spiller
Effectiveness of Yi-Zhi-An-Shen granules on cognition and sleep quality in older adults with amnestic mild cognitive impairment: protocol for a randomized, double-blind, placebo-controlled trial
Shengnan Yue, Ting He, Baiyang Li, Yanqin Qu, Hongmei Peng, Jinxin Chen, Ming Lei, Chongli Chen, Wenbin Wu
Covered stents versus Bare-metal stents in chronic atherosclerotic Gastrointestinal Ischemia (CoBaGI): study protocol for a randomized controlled trial
Louisa J. D. van Dijk, Jihan Harki, Desirée van Noord, Hence J. M. Verhagen, Jeroen J. Kolkman, Robert H. Geelkerken, Marco J. Bruno, Adriaan Moelker, Ron Balm, Gert Jan de Borst, Juliette T. Blauw, Marco J. Bruno, Olaf J. Bakker, Louisa J. D. van Dijk, Hessel C. J. L. Buscher, Bram Fioole, Robert H. Geelkerken, Jaap F. Hamming, Jihan Harki, Daniel A. F. van den Heuvel, Eline S. van Hattum, Jan Willem Hinnen, Jeroen J. Kolkman, Maarten J. van der Laan, Kaatje Lenaerts, Adriaan Moelker, Desirée van Noord, Maikel P. Peppelenbosch, André S. van Petersen, Pepijn Rijnja, Peter J. van der Schaar, Luke G. Terlouw, Hence J. M. Verhagen, Jean Paul P. M. de Vries, Dammis Vroegindeweij
The efficacy and safety of Shenzhu Guanxin Recipe Granules for the treatment of patients with coronary artery disease: protocol for a double-blind, randomized controlled trial
Xiao Jin, Biqi Pan, Huanlin Wu, Bingxin Wu, Yukai Li, Xia Wang, Guoqing Liu, Xiaojing Dang, Danping Xu
Study protocol for a randomized controlled trial to test for preventive effects of diabetic foot ulceration by telemedicine that includes sensor-equipped insoles combined with photo documentation
Antao Ming, Isabell Walter, Ahmad Alhajjar, Martin Leuckert, Peter R. Mertens
VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho
Alain Amstutz, Thabo Ishmael Lejone, Lefu Khesa, Josephine Muhairwe, Bienvenu Lengo Nsakala, Katleho Tlali, Moniek Bresser, Fabrizio Tediosi, Mathebe Kopo, Mpho Kao, Thomas Klimkait, Manuel Battegay, Tracy Renée Glass, Niklaus Daniel Labhardt
Efficacy of DiaLife, an education program for relatives of adult patients with diabetes – study protocol of a cluster randomized controlled trial
M. Bernard, N. Müller, L. Hecht, G. Fabisch, A. Harder, C. Luck-Sikorski
Investigating causal mechanisms in randomised controlled trials
Hopin Lee, Robert D. Herbert, Sarah E. Lamb, Anne M. Moseley, James H. McAuley
Hope and despair: a qualitative exploration of the experiences and impact of trial processes in a rehabilitation trial
Meriel Norris, Leon Poltawski, Raff Calitri, Anthony I. Shepherd, Sarah G. Dean
Skeletal muscle hypertrophy and attenuation of cardio-metabolic risk factors (SHARC) using functional electrical stimulation-lower extremity cycling in persons with spinal cord injury: study protocol for a randomized clinical trial
Ashraf S. Gorgey, Refka E. Khalil, John C. Davis, William Carter, Ranjodh Gill, Jeannie Rivers, Rehan Khan, Lance L. Goetz, Teodoro Castillo, Timothy Lavis, Adam P. Sima, Edward J. Lesnefsky, Christopher C. Cardozo, Robert A. Adler
Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival
Erinn M. Hade, Gregory S. Young, Richard R. Love
Regional lymphadenectomy vs. extended lymphadenectomy for hilar cholangiocarcinoma (Relay-HC trial): study protocol for a prospective, multicenter, randomized controlled trial
Min He, Xinsen Xu, Hao Feng, Wei Chen, Houbao Liu, Yongjie Zhang, Jianming Wang, Zhimin Geng, Yudong Qiu, Weidong Duan, Xiangcheng Li, Xuting Zhi, Weihua Zhu, Fuyu Li, Jiangtao Li, Shengping Li, Yu He, Zhiwei Quan, Jian Wang
Peer approaches to self-management (PALS): comparing a peer mentoring approach for disease self-management in African American women with lupus with a social support control: study protocol for a randomized controlled trial
Edith M. Williams, Leonard Egede, Jim C. Oates, Clara L. Dismuke, Viswanathan Ramakrishnan, Trevor D. Faith, Hetlena Johnson, Jillian Rose
Preformed pediatric zirconia crown versus preformed pediatric metal crown: study protocol for a randomized clinical trial
Serena Lopez-Cazaux, Elody Aiem, Ana Miriam Velly, Michèle Muller-Bolla
Treatment of carpal tunnel syndrome with wrist splinting: study protocol for a randomized placebo-controlled trial
Isam Atroshi, Kamelia Tadjerbashi, Steven J. McCabe, Jonas Ranstam
Effects of C8 nerve root block during interscalene brachial plexus block on anesthesia of the posterior shoulder in patients undergoing arthroscopic shoulder surgery: study protocol for a prospective randomized parallel-group controlled trial
Eugene Kim, Chang Hyuk Choi, Jong Hae Kim
MOTANA: study protocol to investigate motor cerebral activity during a propofol sedation
Sébastien Rimbert, Denis Schmartz, Laurent Bougrain, Claude Meistelman, Cédric Baumann, Philippe Guerci
An analysis of deficiencies in the data of interventional drug trials registered with Clinical Trials Registry - India
Mounika Pillamarapu, Abhilash Mohan, Gayatri Saberwal
Addressing challenges in tuberculosis adherence via performance-based payments for integrated case management: protocol for a cluster randomized controlled trial in Georgia
Ivdity Chikovani, Karin Diaconu, Predrag Duric, Lela Sulaberidze, Maia Uchaneishvili, Nuredin Ibrahim Mohammed, Akaki Zoidze, Sophie Witter
Si-ni-tang (a Chinese herbal formula) for improving immunofunction in sepsis: study protocol for a pilot randomized controlled trial
Ruifeng Zeng, Yi Zheng, Rongrong Fan, Gengbiao Zhou, Yan Zhang, Shutao Mai, Dongping Xie, Yanna Weng, Jiongdong Du, Yun Han, Fang Lai
Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol for a randomized controlled trial
Ying Ding, Xia Zhang, Xianqing Ren, Wensheng Zhai, Liyun He, Jianping Liu, Chen Yao, Shanshan Han, Long Wang
Comparing the effect of STan (cardiotocographic electronic fetal monitoring (CTG) plus analysis of the ST segment of the fetal electrocardiogram) with CTG alone on emergency caesarean section rates: study protocol for the STan Australian Randomised controlled Trial (START)
D. Turnbull, A. Salter, B. Simpson, B. W. Mol, E. Chandraharan, A. McPhee, I. Symonds, M. Benton, S. Kuah, G. Matthews, K. Howard, C. Wilkinson
A double-blinded, randomized placebo-controlled trial on the effect of traditional Chinese medicine formula Wuzi Yanzong pill on improving semen qualities in men with suboptimal parameters
Mingpeng Zhao, Carol Pui Shan Chan, Cosy Wing Ching Cheung, Odai Alqawasmeh, Ronald Chi Chiu Wang, Justin Che Yuen Wu, Zhi Xiu Lin, Tin Chiu Li, Jacqueline Pui Wah Chung, Jennifer Sze Man Mak, Tracy Sze Man Law, David Yiu Leung Chan
Interventions to promote healthy environments in family child care homes in Oklahoma—Happy Healthy Homes: study protocol for a randomized controlled trial
Susan B. Sisson, Alicia L. Salvatore, Deana Hildebrand, Tiffany Poe, Cady Merchant, Megan Slawinski, Chelsea L. Kracht, Julie A. Stoner, Naneida Alcala Lazarte, Lu Ann Faulkner Schneider, Jennifer Weber, Felecia Jones, Dianne Ward
The effect of different amounts of vitamin D supplementation on serum calcidiol, anthropometric status, and body composition in overweight or obese nursing women: a study protocol for a randomized placebo-controlled clinical trial
Zohre Gerveieeha, Fereydoun Siassi, Mostafa Qorbani, Farzaneh Ziaeian, Gity Sotoudeh
Supporting elderly people with cognitive impairment during and after hospital stays with intersectoral care management: study protocol for a randomized controlled trial
Angela Nikelski, Armin Keller, Fanny Schumacher-Schönert, Terese Dehl, Jessica Laufer, Ulf Sauerbrey, Diana Wucherer, Adina Dreier-Wolfgramm, Bernhard Michalowsky, Ina Zwingmann, Horst Christian Vollmar, Wolfgang Hoffmann, Stefan H. Kreisel, Jochen René Thyrian
Therapy of nodal Follicular Lymphoma (WHO grade 1/2) in clinical stage I/II using response adapted Involved Site Radiotherapy in combination with Obinutuzumab (Gazyvaro) - GAZAI Trial (GAZyvaro and response adapted Involved-site Radiotherapy): a study protocol for a single-arm, non-randomized, open, national, multi-center phase II trial
Laila König, Martin Dreyling, Jan Dürig, Marianne Engelhard, Karin Hohloch, Andreas Viardot, Mathias Witzens-Harig, Meinhard Kieser, Wolfram Klapper, Christiane Pott, Klaus Herfarth
Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan
Felicity L. Brown, Frederik Steen, Karine Taha, May Aoun, Richard A. Bryant, Mark J. D. Jordans, Aiysha Malik, Mark van Ommeren, Adnan Abualhaija, Ibrahim Said Aqel, Maha Ghatasheh, Rand Habashneh, Marit Sijbrandij, Rabih El Chammay, Sarah Watts, Aemal Akhtar
TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: study protocol for a cluster randomised controlled trial
Jessica Frost, J. Athene Lane, Nikki Cotterill, Mandy Fader, Lucy Hackshaw-McGeagh, Hashim Hashim, Margaret Macaulay, Stephanie J. MacNeill, Sian Noble, Jonathan Rees, Matthew J. Ridd, Luke Robles, Gordon Taylor, Jodi Taylor, Marcus J Drake, Jo Worthington
Pragmatic randomised trial of a smartphone app (NRT2Quit) to improve effectiveness of nicotine replacement therapy in a quit attempt by improving medication adherence: results of a prematurely terminated study
Aleksandra Herbec, Jamie Brown, Lion Shahab, Robert West, Tobias Raupach
Using peer education to improve diabetes management and outcomes in a low-income setting: a randomized controlled trial
Till Seuring, Marthoenis, Sabrina Rhode, Lisa Rogge, Holger Rau, Stéphane Besançon, Hendra Zufry, Hizir Sofyan, Sebastian Vollmer
Effect of multidisciplinary intensive targeted care in improving diabetes mellitus outcomes: a randomized controlled pilot study – the Integrated Diabetes Education, Awareness and Lifestyle modification in Singapore (IDEALS) Program
Eberta Tan, Joan Khoo, Linsey Utami Gani, Roy Debajyoti Malakar, Tunn Lin Tay, Prasanna Sivanath Tirukonda, Jia Wen Kam, Aung Soe Tin, Tjun Yip Tang
Smoking cessation Through Optimisation of clinical care in Pregnancy: the STOP randomised controlled trial
Brendan P. McDonnell, Patrick Dicker, Sheila Keogan, Luke Clancy, Carmen Regan
Effects of different acupuncture treatment methods on mild cognitive impairment: a study protocol for a randomized controlled trial
Jae-Hong Kim, Myoung-Rae Cho, Gwang-Cheon Park, Jeong-Soon Lee
Interval-cohort designs and bias in the estimation of per-protocol effects: a simulation study
Jessica G. Young, Rajet Vatsa, Eleanor J. Murray, Miguel A. Hernán
Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events
Evan Mayo-Wilson, Nicole Fusco, Hwanhee Hong, Tianjing Li, Joseph K. Canner, Kay Dickersin
Strengthening Referral Networks for Management of Hypertension Across the Health System (STRENGTHS) in western Kenya: a study protocol of a cluster randomized trial
Tim Mercer, Benson Njuguna, Gerald S. Bloomfield, Jonathan Dick, Eric Finkelstein, Jemima Kamano, Ann Mwangi, Violet Naanyu, Sonak D. Pastakia, Thomas W. Valente, Rajesh Vedanthan, Constantine Akwanalo
N-acetylcysteine for cessation of tobacco smoking: rationale and study protocol for a randomised controlled trial
Lauren Arancini, Chiara C. Bortolasci, Seetal Dodd, Olivia M. Dean, Michael Berk
An evaluation of risk-based monitoring in pragmatic trials in UK Clinical Trials Units
Daniel Beever, Lizzie Swaby
Correction to: Trial of healthy relationship initiatives for the very early years (THRIVE), evaluating Enhanced Triple P for Baby and Mellow Bumps for those with additional social and care needs during pregnancy and their infants who are at higher risk of maltreatment: study protocol for a randomised controlled trial
Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O’Dowd, James Law, Elizabeth McGee, Daniel Wight
Is dangling of the lower leg after a free flap reconstruction necessary? Study protocol for a large multicenter randomized controlled study
David D. Krijgh, Teun Teunis, Pascal P. A. Schellekens, Marc A. M. Mureau, Antonius J. M. Luijsterburg, Tallechien M. T. Tempelman, Eva S. J. van der Beek, Wiesje Maarse, J. Henk Coert
Virtual training leads to real acute physical, cognitive, and neural benefits on healthy adults: study protocol for a randomized controlled trial
Dalila Burin, Noriki Yamaya, Rie Ogitsu, Ryuta Kawashima
Multimodal cardioprotective strategy in cardiac surgery (the ProCCard trial): Study protocol for a multicenter randomized controlled trial
Pascal Chiari, Michel Durand, Olivier Desebbe, Marc-Olivier Fischer, Diane Lena-Quintard, Jean-Charles Palao, Catherine Mercier, Géraldine Samson, Yvonne Varillon, Matteo Pozzi, Nathan Mewton, Delphine Maucort-Boulch, Michel Ovize, Jean-Luc Fellahi
Leucine-enriched essential amino acid supplementation in mechanically ventilated trauma patients: a feasibility study
L. Wandrag, S. J. Brett, G. S. Frost, M. To, E. Alves Loubo, N. C. Jackson, A. M. Umpleby, V. Bountziouka, M. Hickson
Impact of deep water running in interval training (DWR-IT) on body composition, functional capacity, and quality of life in overweight adults: study protocol for a randomized controlled trial
Bruna Pianna, Bianca Christianini Moreno, Caroline Aquino de Souza, Thais Fernanda Bôscoa, Guilherme Eleutério Alcalde, Silvia Regina Barrile, Camila Gimenes, Bruno Martinelli, Antonio Roberto Zamunér, Bruna Varanda Pessoa-Santos, Eduardo Aguilar Arca
The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial
Christian Jons, Peter Sogaard, Steffen Behrens, Jürgen Schrader, Sascha Mrosk, Poul Erik Bloch Thomsen
Manual acupuncture for the infertile female with polycystic ovary syndrome (PCOS): study protocol for a randomized sham-controlled trial
Qiao Wang, Haiping Deng, Ke Cheng, Zouqin Huang, Xiuqi Yin, Yichen Zhou, Yiqin Yang, Weidong Shen, Ling Zhao, Xueyong Shen
Medial malleolus: Operative Or Non-operative (MOON) trial protocol - a prospective randomised controlled trial of operative versus non-operative management of associated medial malleolus fractures in unstable fractures of the ankle
Thomas H. Carter, William M. Oliver, Catriona Graham, Andrew D. Duckworth, Timothy O. White
Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?
Stephen J. Walters, Richard M. Jacques, Inês Bonacho dos Anjos Henriques-Cadby, Jane Candlish, Nikki Totton, Mica Teo Shu Xian
Collaborative care model for treatment of persistent symptoms after concussion among youth (CARE4PCS-II): Study protocol for a randomized, controlled trial
Carolyn A. McCarty, Douglas Zatzick, Teah Hoopes, Katelyn Payne, Rebecca Parrish, Frederick P. Rivara
The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial
Rachana Parikh, Daniel Michelson, Kanika Malik, Sachin Shinde, Helen A. Weiss, Adriaan Hoogendoorn, Jeroen Ruwaard, Madhuri Krishna, Rhea Sharma, Bhargav Bhat, Rooplata Sahu, Sonal Mathur, Paulomi Sudhir, Michael King, Pim Cuijpers, Bruce F. Chorpita, Christopher G. Fairburn, Vikram Patel
The effect of Baduanjin exercise on health-related physical fitness of college students: study protocol for a randomized controlled trial
Fang Zhao, Shanshan Sun, Jian Xiong, Guohua Zheng
The impact of surgeon and patient treatment preferences in an orthopaedic trauma surgery trial
Ada Keding, Helen Handoll, Stephen Brealey, Laura Jefferson, Catherine Hewitt, Belen Corbacho, David Torgerson, Amar Rangan
A review of current practice in the design and assessment of internal pilots in UK NIHR clinical trials
Anna Rosala-Hallas, Carrol Gamble, Jane Blazeby, Paula R. Williamson
Systematic review of basket trials, umbrella trials, and platform trials: a landscape analysis of master protocols
Jay J. H Park, Ellie Siden, Michael J. Zoratti, Louis Dron, Ofir Harari, Joel Singer, Richard T. Lester, Kristian Thorlund, Edward J. Mills
Reducing Asthma Attacks in Children using Exhaled Nitric Oxide as a biomarker to inform treatment strategy: a randomised trial (RAACENO)
S. Turner, S. C. Cotton, C. D. Emele, R. Thomas, S. Fielding, E. A. Gaillard, J. C. de Jongste, H. Morgan, A. R. Neilson, J. Norrie, M. Pijnenburg, D. Price, M. Thomas
Online Social anxiety Cognitive therapy for Adolescents (OSCA): protocol for a randomised controlled trial
Eleanor Leigh, David M. Clark
Efficacy of intergrating vestibular rehabilitation and cognitive behaviour therapy in persons with persistent dizziness in primary care- a study protocol for a randomised controlled trial
Lene Kristiansen, L. H. Magnussen, K. T. Wilhelmsen, S. Mæland, S. H. G. Nordahl, R. Clendaniel, A. Hovland, B. Juul-Kristensen
An electronic family health history tool to identify and manage patients at increased risk for colorectal cancer: protocol for a randomized controlled trial
Karen M. Goldstein, Deborah A. Fisher, R. Ryanne Wu, Lori A. Orlando, Cynthia J. Coffman, Janet M. Grubber, Tejinder Rakhra-Burris, Virginia Wang, Maren T. Scheuner, Nina Sperber, Santanu K. Datta, Richard E. Nelson, Elizabeth Strawbridge, Dawn Provenzale, Elizabeth R. Hauser, Corrine I. Voils
Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis
Sravya Kakumanu, Braden J. Manns, Sophia Tran, Terry Saunders-Smith, Brenda R. Hemmelgarn, Marcello Tonelli, Ross Tsuyuki, Noah Ivers, Danielle Southern, Jeff Bakal, David J. T. Campbell
Development, acceptability, appropriateness and appeal of a cancer clinical trials implementation intervention for rural- and minority-serving urology practices
Shellie Ellis, Mugur Geana, Tomas Griebling, Charles McWilliams, Jessie Gills, Kelly Stratton, Christine Mackay, Ariel Shifter, Andrew Zganjar, Brantley Thrasher
Effect of probiotic supplementation in nonalcoholic steatohepatitis patients: PROBILIVER TRIAL protocol
Amanda Souza Silva-Sperb, Helena Abadie Moraes, Bruna Concheski de Moura, Bruna Cherubini Alves, Juliana Paula Bruch-Bertani, Vittoria Zambon Azevedo, Valesca Dall’Alba
Social group and health care provider interventions to increase the demand for malaria rapid diagnostic test among community members in Ebonyi state, Nigeria: study protocol for a cluster randomized controlled trial
Ugwu I. Omale, Benedict N. Azuogu, Chihurumnanya Alo, Ugochukwu C. Madubueze, Onyinyechukwu U. Oka, Kingsley C. Okeke, Ifeyinwa M. Okafor, Rowland Utulu, Uduak E. Akpan, Chijioke V. Iloke, Anthonia O. Nnubia, Ifeyinwa I. Eze, Ogechukwu C. Anene, Chukwuka R. Nnabu, Deborah C. Ibemesi
The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial
M. Wijnberge, J. Schenk, L. E. Terwindt, M. P. Mulder, M. W. Hollmann, A. P. Vlaar, D. P. Veelo, B. F. Geerts
Contributions of vitamin D in the management of depressive symptoms and cardiovascular risk factors: study protocol for a randomized, double-blind, placebo-controlled clinical trial
Catarina Magalhães Porto, Tatiana de Paula Santana da Silva, Everton Botelho Sougey
The Salt Swap intervention to reduce salt intake in people with high blood pressure: protocol for a feasibility randomised controlled trial
Sarah Payne Riches, Carmen Piernas, Paul Aveyard, James P. Sheppard, Mike Rayner, Susan A. Jebb
Comparison of the effect of three different protein content enteral diets on serum levels of proteins, nitrogen balance, and energy expenditure in critically ill infants: study protocol for a randomized controlled trial
Reyes Fernández, Javier Urbano, Ángel Carrillo, Ana Vivanco, María José Solana, Corsino Rey, Jesús López-Herce
Effects of neuromuscular training and strengthening of trunk and lower limbs muscles in women with Patellofemoral Pain: A protocol of randomized controlled clinical trial, blinded
Natália Camin Silva, Matheus de Castro Silva, Morisa Garcia Guimarães, Manoela Beatriz de Oliveira Nascimento, Lilian Ramiro Felicio
Frequency of Screening and SBT Technique Trial - North American Weaning Collaboration (FAST-NAWC): a protocol for a multicenter, factorial randomized trial
K. E. A. Burns, Leena Rizvi, Deborah J. Cook, Andrew J. E. Seely, Bram Rochwerg, Francois Lamontagne, John W. Devlin, Peter Dodek, Michael Mayette, Maged Tanios, Audrey Gouskos, Phyllis Kay, Susan Mitchell, Kenneth C. Kiedrowski, Nicholas S. Hill
Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial
Malin E. Carmland, Melissa Kreutzfeldt, Jakob V. Holbech, Niels T. Andersen, Troels S. Jensen, Flemming W. Bach, Søren H. Sindrup, Nanna B. Finnerup
Harmonisation of Outcome Parameters and Evaluation (HOPE) for actinic keratosis: protocol for the development of a core outcome set
Markus V. Heppt, Theresa Steeb, Lutz Schmitz, Claus Garbe, Lars E. French, Ulrike Leiter, Carola Berking
The effect of spinal manipulative therapy on heart rate variability and pain in patients with chronic neck pain: a randomized controlled trial
Anders Galaasen Bakken, Iben Axén, Andreas Eklund, Søren O’Neill
A randomised controlled trial exploring the impact of a dedicated health and social care professionals team in the emergency department on the quality, safety, clinical and cost-effectiveness of care for older adults: a study protocol
Marica Cassarino, Katie Robinson, Íde O’Shaughnessy, Eimear Smalle, Stephen White, Collette Devlin, Rosie Quinn, Dominic Trépel, Fiona Boland, Marie E. Ward, Rosa McNamara, Margaret O’Connor, Gerard McCarthy, Damien Ryan, Rose Galvin
The TREATT Trial (TRial to EvaluAte Tranexamic acid therapy in Thrombocytopenia): safety and efficacy of tranexamic acid in patients with haematological malignancies with severe thrombocytopenia: study protocol for a double-blind randomised controlled trial
Lise J. Estcourt, Zoe McQuilten, Gillian Powter, Claire Dyer, Eleanor Curnow, Erica M. Wood, Simon J. Stanworth
What are the most important unanswered research questions in trial retention? A James Lind Alliance Priority Setting Partnership: the PRioRiTy II (Prioritising Retention in Randomised Trials) study
Dan Brunsdon, Linda Biesty, Peter Brocklehurst, Valerie Brueton, Declan Devane, Jim Elliott, Sandra Galvin, Carrol Gamble, Heidi Gardner, Patricia Healy, Kerenza Hood, Joan Jordan, Doris Lanz, Beccy Maeso, Amanda Roberts, Imogen Skene, Irene Soulsby, Derek Stewart, David Torgerson, Shaun Treweek, Caroline Whiting, Sharon Wren, Andrew Worrall, Katie Gillies
The trial to reduce antimicrobial use in nursing home residents with Alzheimer’s disease and other dementias: study protocol for a cluster randomized controlled trial
Andrea J. Loizeau, Erika M. C. D’Agata, Michele L. Shaffer, Laura C. Hanson, Ruth A. Anderson, Timothy Tsai, Daniel A. Habtemariam, Elaine H. Bergman, Ruth P. Carroll, Simon M. Cohen, Erin M. E. Scott, Erin Stevens, Jeremy D. Whyman, Elizabeth H. Bennert, Susan L. Mitchell
Correction to: 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
Effects of transcranial direct current stimulation on patients with disorders of consciousness after traumatic brain injury: study protocol for a randomized, double-blind controlled trial
Shilin Li, Xiangli Dong, Weiming Sun, Na Zhao, Guohua Yu, Lang Shuai
Load monitoring on Pilates training: a study protocol for a randomized clinical trial
Allysiê Priscilla de Souza Cavina, Eduardo Pizzo Junior, Aryane Flauzino Machado, Taíse Mendes Biral, Carlos Marcelo Pastre, Franciele Marques Vanderlei
Patient experiences of participation in a radical thoracic surgical trial: findings from the Mesothelioma and Radical Surgery Trial 2 (MARS 2)
Clare Warnock, Karen Lord, Bethany Taylor, Angela Tod
Enhanced recovery after surgery (ERAS) pathway for primary hip and knee arthroplasty: study protocol for a randomized controlled trial
Jingyi Li, Haibei Zhu, Ren Liao
The necessity of IIb dissection in T1–T2N0M0 oral squamous cell carcinoma: protocol for a randomized controlled trial
Lei Wang, Liang Wang, Xuefei Song, Chang Cui, Chunyue Ma, Bing Guo, Xingjun Qin
Effect of etelcalcetide on cardiac hypertrophy in hemodialysis patients: a randomized controlled trial (ETECAR-HD)
Katharina Dörr, Michael Kammer, Roman Reindl-Schwaighofer, Matthias Lorenz, Christian Loewe, Rodrig Marculescu, Reinhold Erben, Rainer Oberbauer
Correction to: 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
Protocol for a multi-centered, stepped wedge, cluster randomized controlled trial of the de-adoption of oral chlorhexidine prophylaxis and implementation of an oral care bundle for mechanically ventilated critically ill patients: the CHORAL study
Craig M. Dale, Louise Rose, Sarah Carbone, Orla M. Smith, Lisa Burry, Eddy Fan, Andre Carlos Kajdacsy-Balla Amaral, Victoria A. McCredie, Ruxandra Pinto, Carlos R. Quiñonez, Susan Sutherland, Damon C. Scales, Brian H. Cuthbertson
Multimodal analysis of the effects of dexamethasone on high-altitude cerebral oedema: protocol for a pilot study
O. Fisher, R. A. Benson, S. Wayte, P. K. Kimani, C. Hutchinson, C. H. E. Imray
Sahaj Samadhi meditation vs a Health Enhancement Program in improving late-life depression severity and executive function: study protocol for a two-site, randomized controlled trial
Stephen Benjamin Peckham, Emily Ionson, Marouane Nassim, Kevin Ojha, Lena Palaniyappan, Joe Gati, Jean Thebérge, Andrea Lazosky, Mark Speechley, Imants Barušs, Soham Rej, Akshya Vasudev
Correction to: Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
Devin S. McCaskell, Alexander J. Molloy, Laura Childerhose, F. Aileen Costigan, Julie C. Reid, Magda McCaughan, France Clarke, Deborah J. Cook, Jill C. Rudkowski, Christopher Farley, Tim Karachi, Bram Rochwerg, Anastasia Newman, Alison Fox-Robichaud, Margaret S. Herridge, Vincent Lo, Deanna Feltracco, Karen E. A. Burns, Rebecca Porteous, Andrew J. E. Seely, Ian M. Ball, Amy Seczek, Michelle E. Kho
Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials)
Nadja Kehler Curth, Ursula Brinck-Claussen, Kirstine Bro Jørgensen, Susanne Rosendal, Carsten Hjorthøj, Merete Nordentoft, Lene Falgaard Eplov
A randomized controlled trial comparing lithium plus valproic acid versus lithium plus carbamazepine in young patients with type 1 bipolar disorder: the LICAVAL study
Giovani Missio, Doris Hupfeld Moreno, Frederico Navas Demetrio, Marcio Gerhardt Soeiro-de-Souza, Fernando dos Santos Fernandes, Vivian Boschesi Barros, Ricardo Alberto Moreno
Pain REduction with bone metastases STereotactic radiotherapy (PREST): A phase III randomized multicentric trial
Francesco Cellini, Stefania Manfrida, Francesco Deodato, Savino Cilla, Ernesto Maranzano, Stefano Pergolizzi, Fabio Arcidiacono, Rossella Di Franco, Francesco Pastore, Matteo Muto, Valentina Borzillo, Costanza Maria Donati, Giambattista Siepe, Salvatore Parisi, Antonia Salatino, Antonino D’Agostino, Giampaolo Montesi, Anna Santacaterina, Vincenzo Fusco, Mario Santarelli, Maria Antonietta Gambacorta, Renzo Corvò, Alessio Giuseppe Morganti, Valeria Masiello, Paolo Muto, Vincenzo Valentini
Correction to: 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
Correction to: Sample size estimation for randomised controlled trials with repeated assessment of patient-reported outcomes: what correlation between baseline and follow-up outcomes should we assume?
Stephen J. Walters, Richard M. Jacques, Inês Bonacho dos Anjos Henriques-Cadby, Jane Candlish, Nikki Totton, Mica Teo Shu Xian
CICAFAST: comparison of a biological dressing composed of fetal fibroblasts and keratinocytes on a split-thickness skin graft donor site versus a traditional dressing: a randomized controlled trial
Alexandra Poinas, Pierre Perrot, Judith Lorant, Olivier Nerrière, Jean-Michel Nguyen, Soraya Saiagh, Cécile Frenard, Audrey Leduc, Olivier Malard, Florent Espitalier, Franck Duteille, Anne Chiffoleau, Florence Vrignaud, Amir Khammari, Brigitte Dréno
Reducing research waste by promoting informed responses to invitations to participate in clinical trials
Katie Gillies, Iain Chalmers, Paul Glasziou, Diana Elbourne, Jim Elliott, Shaun Treweek
Neuropsychological management of multiple sclerosis: evaluation of a supervised and customized cognitive rehabilitation program for self-used at home (SEPIA): protocol for a randomized controlled trial
Caroline Harand, France Daniel, Audrey Mondou, Damien Chevanne, Christian Creveuil, Gilles Defer
Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial
Marijke Dieltjens, Marc J. Braem, Sara Op de Beeck, Anneclaire V. M. T. Vroegop, Elahe Kazemeini, Eli Van de Perck, Jolien Beyers, Chloé Kastoer, Kristien Wouters, Marc Willemen, Johan A. Verbraecken, Olivier M. Vanderveken
European survey on national training activities in clinical research
A. Magnin, V. Cabral Iversen, G. Calvo, B. Čečetková, O. Dale, R. Demlova, Gy. Blasko, F. Keane, G. L. Kovacs, C. Levy-Marchal, E. C. Monteiro, L. Palmisano, D. Pella, A. Portolés Pérez, O. Rascol, C. Schmid, F. Tay, H. von der Leyen, C. Ohmann
Correction to: Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan
Felicity L. Brown, Frederik Steen, Karine Taha, May Aoun, Richard A. Bryant, Mark J. D. Jordans, Aiysha Malik, Mark van Ommeren, Adnan Abualhaija, Ibrahim Said Aqel, Maha Ghatasheh, Rand Habashneh, Marit Sijbrandij, Rabih El Chammay, Sarah Watts, Aemal Akhtar
Identifying important barriers to recruitment of patients in randomised clinical studies using a questionnaire for study personnel
Eva Isaksson, Per Wester, Ann Charlotte Laska, Per Näsman, Erik Lundström
PROtective Ventilation with a low versus high Inspiratory Oxygen fraction (PROVIO) and its effects on postoperative pulmonary complications: protocol for a randomized controlled trial
Xue-Fei Li, Dan Jiang, Yu-Lian Jiang, Hong Yu, Jia-Li Jiang, Lei-Lei He, Xiao-Yun Yang, Hai Yu
Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial
Katie Biggs, Daniel Hind, Mike Bradburn, Lizzie Swaby, Steve Brown
Recruitment effort and costs from a multi-center randomized controlled trial for treating depression in type 2 diabetes
Barbara A. Myers, Yegan Pillay, W. Guyton Hornsby Jr, Jay Shubrook, Chandan Saha, Kieren J. Mather, Karen Fitzpatrick, Mary de Groot
Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial
Francisco De la Gala, Patricia Piñeiro, Almudena Reyes, Carlos Simón, Elena Vara, Lisa Rancan, Luis Javier Huerta, Guillermo Gonzalez, Carmen Benito, Marta Muñoz, Pilar Grande, Sergio D. Paredes, Pablo Tomas Aznar, Alvaro Perez, David Martinez, Fernando Higuero, David Sanz, Juan Pedro De Miguel, Patricia Cruz, Luis Olmedilla, Elena Lopez Gil, Patricia Duque, Guillermo Sanchez-Pedrosa, Mayte Valle, Ignacio Garutti
The best from East and West? Acupuncture and medical training therapy as monotherapies or in combination for adult patients with episodic and chronic tension-type headache: study protocol for a randomized controlled trial
J. Schiller, T. Kellner, J. Briest, K. Hoepner, A. Woyciechowski, A. Ostermann, C. Korallus, C. Sturm, T. Weiberlenn, L. Jiang, C. Egen, F. Beissner, M. Stiesch, M. Karst, C. Gutenbrunner, M. G. Fink
Designing and using incentives to support recruitment and retention in clinical trials: a scoping review and a checklist for design
Beth Parkinson, Rachel Meacock, Matt Sutton, Eleonora Fichera, Nicola Mills, Gillian W. Shorter, Shaun Treweek, Nicola L Harman, Rebecca C. H. Brown, Katie Gillies, Peter Bower
Effect of acupuncture on lung cancer-related fatigue: study protocol for a multi-center randomized controlled trial
Zhaoqin Wang, Shanshan Li, Luyi Wu, Qin Qi, Huirong Liu, Xiaoming Jin, Jianhui Tian, Ming Zhang, Xiaopeng Ma, Deli Sun, Shifen Xu, Huangan Wu
Effects of motor imagery training of Parkinson's disease: a protocol for a randomized clinical trial
Isaíra Almeida Pereira da Silva Nascimento, Lorenna Marques de Melo Santiago, Aline Alves de Souza, Camila de Lima Pegado, Tatiana Souza Ribeiro, Ana Raquel Rodrigues Lindquist
Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)
Jeanette Trøstrup, Lone Ramer Mikkelsen, Poul Frost, Annett Dalbøge, Mette Terp Høybye, Sven Dalgas Casper, Lene Bastrup Jørgensen, Thomas Martin Klebe, Susanne Wulff Svendsen
Correction to: Contributions of Vitamin D in the management of depressive symptoms and cardiovascular risk factors: study protocol for a randomized, double-blind, placebo-controlled clinical trial
Catarina Magalhães Porto, Tatiana de Paula Santana da Silva, Everton Botelho Sougey
Room4Birth - the effect of an adaptable birthing room on labour and birth outcomes for nulliparous women at term with spontaneous labour start: study protocol for a randomised controlled superiority trial in Sweden
Marie Berg, Lisa Goldkuhl, Christina Nilsson, Helle Wijk, Hanna Gyllensten, Göran Lindahl, Kerstin Uvnäs Moberg, Cecily Begley
Comments on “Reporting quality of randomized controlled trial abstracts in the seven highest-ranking anesthesiology journals”
Rohan Kumar Ochani, Asim Shaikh, Naser Yamani
Effectiveness of music therapy for alleviating pain during haemodialysis access cannulation for patients undergoing haemodialysis: a multi-facility, single-blind, randomised controlled trial
Masatsugu Kishida, Yosuke Yamada, Emi Inayama, Mineaki Kitamura, Tomoya Nishino, Keiko Ota, Ayumi Shintani, Tatsuyoshi Ikenoue
Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial
Clara Sanches, Richard Levy, Sarah Benisty, Lisette Volpe-Gillot, Marie-Odile Habert, Aurelie Kas, Sébastian Ströer, Nadya Pyatigorskaya, Anna Kaglik, Angelina Bourbon, Bruno Dubois, Raffaella Migliaccio, Antoni Valero-Cabré, Marc Teichmann
Liraglutide and the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first-episode psychosis: protocol for a pilot trial
Clare Alexandra Whicher, Hermione Clare Price, Peter Phiri, Shanaya Rathod, Katharine Barnard-Kelly, Claire Reidy, Kerensa Thorne, Carolyn Asher, Robert Peveler, Joanne McCarthy, Richard Ian Gregory Holt
A mobile device app to reduce prehospital medication errors and time to drug preparation and delivery by emergency medical services during simulated pediatric cardiopulmonary resuscitation: study protocol of a multicenter, prospective, randomized controlled trial
Johan N. Siebert, Laurie Bloudeau, Frédéric Ehrler, Christophe Combescure, Kevin Haddad, Florence Hugon, Laurent Suppan, Frédérique Rodieux, Christian Lovis, Alain Gervaix, Sergio Manzano
The DREAM Initiative: study protocol for a randomized controlled trial testing an integrated electronic health record and community health worker intervention to promote weight loss among South Asian patients at risk for diabetes
Sahnah Lim, Laura C. Wyatt, Shinu Mammen, Jennifer M. Zanowiak, Sadia Mohaimin, Keith S. Goldfeld, Donna Shelley, Heather T. Gold, Nadia S. Islam
Reduction of the long-term use of proton pump inhibitors by a patient-oriented electronic decision support tool (arriba-PPI): study protocol for a randomized controlled trial
Anja Rieckert, Annette Becker, Norbert Donner-Banzhof, Annika Viniol, Bettina Bücker, Stefan Wilm, Andreas Sönnichsen, Anne Barzel
Tamoxifen in Duchenne muscular dystrophy (TAMDMD): study protocol for a multicenter, randomized, placebo-controlled, double-blind phase 3 trial
Sara Nagy, Patricia Hafner, Simone Schmidt, Daniela Rubino-Nacht, Sabine Schädelin, Oliver Bieri, Dirk Fischer
A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol
Magdalena Szewczyk-Bieda, Cheng Wei, Katherine Coll, Stephen Gandy, Peter Donnan, Senthil Kumar Arcot Ragupathy, Paras Singh, Jennifer Wilson, Ghulam Nabi
Delivery of home-based postpartum contraception in rural Guatemalan women: a cluster-randomized trial protocol
Margo S. Harrison, Saskia Bunge-Montes, Claudia Rivera, Andrea Jimenez-Zambrano, Gretchen Heinrichs, Sharon Scarbro, Elizabeth Juarez-Colunga, Antonio Bolanos, Edwin Asturias, Stephen Berman, Jeanelle Sheeder
Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)
Daniel Hayes, Anna Moore, Emily Stapley, Neil Humphrey, Rosie Mansfield, Joao Santos, Emma Ashworth, Praveetha Patalay, Eva-Maria Bonin, Bettina Moltrecht, Jan R. Boehnke, Jessica Deighton
Radiotherapy versus radiotherapy combined with temozolomide in high-risk low-grade gliomas after surgery: study protocol for a randomized controlled clinical trial
Jingjing Wang, Ying Wang, Yan He, Hui Guan, Ling He, Xiaoli Mu, Xingchen Peng
Eye movement desensitization and reprocessing (EMDR) therapy for posttraumatic stress disorder in adults with serious mental illness within forensic and rehabilitation services: a study protocol for a randomized controlled trial
Susanna Every-Palmer, Tom Flewett, Shaystah Dean, Oliver Hansby, Atalie Colman, Mark Weatherall, Elliot Bell
The effectiveness of an interactive organ donation education intervention for Dutch lower-educated students: a cluster randomized controlled trial
Esther Steenaart, Rik Crutzen, Math J. J. M. Candel, Nanne K. de Vries
Efficacy of verum and sham acupoint catgut embedding for treatment of obesity: Study protocol for a randomized controlled trial
Yu-Mei Zhou, Bing Yan, Wei-Qu Yuan, Hai-Bo Yu, Zhuo-Xin Yang
Influence of volatile anesthesia versus total intravenous anesthesia on chronic postsurgical pain after cardiac surgery using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials criteria: study protocol for a prospective randomized controlled trial
Hong Yu, Jian-Qiao Zheng, Yu-Si Hua, Shuo-Fang Ren, Hai Yu
A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial
Pernille Langer Soendergaard, Mia Moth Wolffbrandt, Fin Biering-Sørensen, Malin Nordin, Trine Schow, Juan Carlos Arango-Lasprilla, Anne Norup
Effects of the Chinese herbal formula San-Huang Gu-Ben Zhi-Ke treatment on stable chronic obstructive pulmonary disease: study protocol of a randomized, double-blind, placebo-controlled trial
Yaqi Zu, Demin Li, Xiang Lei, Hongchun Zhang
Metronidazole versus lactic acid for treating bacterial vaginosis (VITA): protocol for a randomised controlled trial to assess the clinical and cost effectiveness of topical lactic acid gel for treating second and subsequent episodes of bacterial vaginosis
Lindsay Armstrong-Buisseret, Clare Brittain, Miruna David, Gillian Dean, Frances Griffiths, Trish Hepburn, Louise Jackson, Joe Kai, Alan Montgomery, Tracy Roberts, Sukhwinder Thandi, Jonathan D. C. Ross
TRIal to slow the Progression Of Diabetes (TRIPOD): study protocol for a randomized controlled trial using wireless technology and incentives
Robyn Su May Lim, Daphne Su Lyn Gardner, Yong Mong Bee, Yin Bun Cheung, Joann Bairavi, Mihir Gandhi, Su-Yen Goh, Emily Tse Lin Ho, Xinyi Lin, Ngiap Chuan Tan, Tunn Lin Tay, Eric Andrew Finkelstein
Safety and efficacy of PG102P for the control of pruritus in patients undergoing hemodialysis (SNUG trial): study protocol for a randomized controlled trial
Yong Chul Kim, Jae Yoon Park, Sohee Oh, Jang-Hee Cho, Jae Hyun Chang, Dae Eun Choi, Jung Tak Park, Jung Pyo Lee, Sejoong Kim, Dong Ki Kim, Dong-Ryeol Ryu, Chun Soo Lim
Chimney Trial: study protocol for a randomized controlled trial
Elisa Mäkäräinen-Uhlbäck, Heikki Wiik, Jyrki Kössi, Maziar Nikberg, Pasi Ohtonen, Tero Rautio
Efficiency and safety of renal denervation via cryoablation (Cryo-RDN) in Chinese patients with uncontrolled hypertension: study protocol for a randomized controlled trial
Han Chen, Meng Ji, Yi Zhang, Yawei Xu, Lingjuan Qiao, Li Shen, Junbo Ge
A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial
Olga Sacristan-Martin, Miguel A. Santed, Javier Garcia-Campayo, Larissa G. Duncan, Nancy Bardacke, Carmen Fernandez-Alonso, Gloria Garcia-Sacristan, Diana Garcia-Sacristan, Alberto Barcelo-Soler, Jesus Montero-Marin
A randomized controlled trial of the effect of supervised progressive cross-continuum strength training and protein supplementation in older medical patients: the STAND-Cph trial
Mette Merete Pedersen, Janne Petersen, Nina Beyer, Helle Gybel-Juul Larsen, Pia Søe Jensen, Ove Andersen, Thomas Bandholm, Ove Andersen, Thomas Bandholm, Jonathan F. Bean, Nina Beyer, Ann Christine Bodilsen, Rasmus Brødsgaard, Jette Christensen, Line Due Christensen, Christina Dahl, Lars Damkjær, Simon Hegnsvad, Pia Søe Jensen, Karen Dalsgaard Jepsen, Helle Gybel Juul-Larsen, Louise Lawson-Smith, Morten Ledertoug, Robert-Jan Nienhuis, Sanne Stiberg, Maja Pedersen, Mette Merete Pedersen, Frida Margareta Persson, Janne Petersen, Trine Rehfeld Lind, Rikke Friis Knudsen, Gitte Salomonsen, Bettina Solgaard, Lisbeth Sommer, Maria Therese Stage, Berit Thorslund, Marie West, Jade Kavanaugh Wulff
Understanding implementation fidelity in a pragmatic randomized clinical trial in the nursing home setting:a mixed-methods examination
Jennifer A. Palmer, Victoria A. Parker, Lacey R. Barre, Vincent Mor, Angelo E. Volandes, Emmanuelle Belanger, Lacey Loomer, Ellen McCreedy, Susan L. Mitchell
The effects of oral vitamin D supplementation on the prevention of peritoneal dialysis-related peritonitis: study protocol for a randomized controlled clinical trial
Yu-hui Zhang, Xiao Xu, Hai-chen Pi, Zhi-kai Yang, David W. Johnson, Jie Dong
ENACT: a protocol for a randomised placebo-controlled trial investigating the efficacy and mechanisms of action of adjunctive N-acetylcysteine for first-episode psychosis
S. M. Cotton, M. Berk, A. Watson, S. Wood, K. Allott, C. F. Bartholomeusz, C. C. Bortolasci, K. Walder, B. O’Donoghue, O. M. Dean, A. Chanen, G. P. Amminger, P. D. McGorry, A. Burnside, J. Uren, A. Ratheesh, S. Dodd
Examining the effectiveness of general practitioner and nurse promotion of electronic cigarettes versus standard care for smoking reduction and abstinence in hardcore smokers with smoking-related chronic disease: protocol for a randomised controlled trial
Rachna Begh, Tim Coleman, Lucy Yardley, Rebecca Barnes, Felix Naughton, Hazel Gilbert, Anne Ferrey, Claire Madigan, Nicola Williams, Louisa Hamilton, Yolanda Warren, Jenna Grabey, Miranda Clark, Anne Dickinson, Paul Aveyard
Structured, proactive care coordination versus usual care for Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS): a pragmatic, randomized controlled trial
Marc Kowalkowski, Shih-Hsiung Chou, Andrew McWilliams, Cathryn Lashley, Stephanie Murphy, Whitney Rossman, Alfred Papali, Alan Heffner, Mark Russo, Larry Burke, Michael Gibbs, Stephanie P. Taylor, Ryan Brown, Larry Burke, Shih-Hsiung Chou, Kyle Cunningham, Susan L. Evans, Scott Furney, Michael Gibbs, Alan Heffner, Timothy Hetherington, Daniel Howard, Marc Kowalkowski, Scott Lindblom, Andrea McCall, Lewis McCurdy, Andrew McWilliams, Stephanie Murphy, Alfred Papali, Christopher Polk, Whitney Rossman, Michael Runyon, Mark Russo, Melanie Spencer, Brice Taylor, Stephanie Taylor
Hygiene protocols for the treatment of denture-related stomatitis: local and systemic parameters analysis - a randomized, double-blind trial protocol
Adriana B. Ribeiro, Camila B. de Araújo, Luiz Eduardo V. Silva, Rubens Fazan-Junior, Helio C. Salgado, Aline B. Ribeiro, Caroline V. Fortes, Frank L. Bueno, Viviane C. de Oliveira, Helena de F. O. Paranhos, Evandro Watanabe, Cláudia H. da Silva-Lovato
eHealth-supported case management for patients with panic disorder or depression in primary care: Study protocol for a cRCT (PREMA)
Karoline Lukaschek, Karola Mergenthal, Dirk Heider, Alexander Hanke, Kathrein Munski, Anne Moschner, Michelle Emig, Marjan van den Akker, Antonia Zapf, Karl Wegscheider, Hans-Helmut König, Jochen Gensichen, K. Rupp, K. Munski, A. Moschner, M. Fellinghauer, A. Hanke, J. Gensichen, K. Lukaschek, T. Dreischulte, S. Schlüssel, H. H. König, D. Heider, K. Wegscheider, F. M. Gerlach, M. van den Akker, K. Mergenthal, M. Hanf, V. Wallraff, J. Schelling
Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II)
Philip Asherson, Lena Johansson, Rachel Holland, Tom Fahy, Andrew Forester, Sheila Howitt, Stephen Lawrie, John Strang, Susan Young, Sabine Landau, Lindsay Thomson
Individualised behaviour change strategies for physical activity in multiple sclerosis (IPAC-MS): protocol for a randomised controlled trial
Farren L. Goulding, Charity D. Evans, Katherine B. Knox, Hyun J. Lim, Michael C. Levin, Sarah J. Donkers
Sample size re-estimation in crossover trials: application to the AIM HY-INFORM study
Julie Wych, Michael J. Grayling, Adrian P. Mander
Healthy lifestyle consultation based on traditional Chinese medicine versus routine patient education in the treatment of idiopathic sudden sensorineural hearing loss after failure of systemic therapy: study protocol for a clinical randomised trial
Ying-ping Fei, Yun Zheng, Dan Lai, Ping Zhong, Jing-zhe Lu, Gang Li, Peng Liu
Cognitive behavioural therapy for insomnia (CBTi) as a treatment for tinnitus-related insomnia: protocol for a randomised controlled trial
E. Marks, C. Hallsworth, L. McKenna
Improving risk perception and uptake of pre-exposure prophylaxis (PrEP) through interactive feedback-based counselling with and without community engagement in young women in Manicaland, East Zimbabwe: study protocol for a pilot randomized trial
Ranjeeta Thomas, Morten Skovdal, Matteo M. Galizzi, Robin Schaefer, Louisa Moorhouse, Constance Nyamukapa, Rufurwokuda Maswera, Phyllis Mandizvidza, Timothy B. Hallett, Simon Gregson
Completeness of reporting in abstracts of randomized controlled trials in subscription and open access journals: cross-sectional study
Iva Jerčić Martinić-Cezar, Ana Marušić
Update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol: statistical analysis plan for a prospective, multicenter, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial
Christopher J. Lindsell, Anna McGlothlin, Samuel Nwosu, Todd W. Rice, Alex Hall, Gordon R. Bernard, Laurence W. Busse, E. Wesley Ely, Alpha A. Fowler, David F. Gaieski, Jeremiah S. Hinson, Michael H. Hooper, James C. Jackson, Gabor D. Kelen, Mark Levine, Greg S. Martin, Richard E. Rothman, Jonathan E. Sevransky, Kert Viele, David W. Wright, David N. Hager
Effectiveness of upgraded maternity waiting homes and local leader training in improving institutional births among women in the Jimma zone, Ethiopia: study protocol for a cluster-randomized controlled trial
Jaameeta Kurji, Manisha A. Kulkarni, Lakew Abebe Gebretsadik, Muluemebet Abera Wordofa, Sudhakar Morankar, Kunuz Haji Bedru, Gebeyehu Bulcha, Kednapa Thavorn, Ronald Labonte, Monica Taljaard
Protocol for a phase III wait-listed cluster randomised controlled trial of an intervention for mental well-being through enhancing mental health literacy and improving work friendliness in Hong Kong
Lawrence T. Lam, Prudence Wong, Mary K. Lam
Fire acupuncture for mild to moderate knee osteoarthritis: a protocol for a randomized controlled pilot trial
Yuan-Bo Fu, Bin Li, San-Feng Sun, Hui-Lin Liu, Xin Wang, Shao-Song Wang, Fan Zhang, Xin Du, Du-Juan Ge, Lei Shang, Rui-Li Liang, Li-Na Wang, Fang Yuan, Jing-Qing Sun, Jun-Wei Chen
Fire needle acupuncture or moxibustion for chronic plaque psoriasis: study protocol for a randomized controlled trial
Zhaoxia Chen, Dongmei Zhou, Yan Wang, Haibing Lan, Xingwu Duan, Bohua Li, Jingxia Zhao, Wei Li, Zhengrong Liu, Tingting Di, Xinwei Guo, Jinchao Zhang, Bo Li, Shuo Feng, Ping Li
A double-masked placebo-controlled trial of azithromycin to prevent child mortality in Burkina Faso, West Africa: Community Health with Azithromycin Trial (CHAT) study protocol
Ali Sié, Mamadou Ouattara, Mamadou Bountogo, Cheik Bagagnan, Boubacar Coulibaly, Valentin Boudo, Elodie Lebas, Jessica M. Brogdon, Ying Lin, Till Bärnighausen, Travis C. Porco, Thuy Doan, Thomas M. Lietman, Catherine E. Oldenburg
Reporting checklists are used as measurement tools for assessing quality, even though they have not been validated for such use
Livia Puljak
Randomised controlled trial on vitreoretinal surgery with and without oral anticoagulants: surgical complications, visual results and perioperative thromboembolic events
Jose Andonegui, Ferran Capdevila, Alicia Zubicoa, Berta Ibáñez
Compression therapy following ClariVein® ablation therapy: a randomised controlled trial of COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA)
Doireann P. Joyce, Stewart R. Walsh, Charyl J. Q. Yap, Tze T. Chong, Tjun Y. Tang
Solar-powered oxygen delivery for the treatment of children with hypoxemia: protocol for a cluster-randomized stepped-wedge controlled trial in Uganda
Nicholas Conradi, Qaasim Mian, Sophie Namasopo, Andrea L. Conroy, Laura L. Hermann, Charles Olaro, Jackson Amone, Robert O. Opoka, Michael T. Hawkes
Effects of combining functional exercises with exercise training on daily physical activities and functionality in patients with COPD: a protocol for a randomized clinical trial
Fabiano Francisco de Lima, Carlos Augusto Camillo, Isis Grigoletto, Juliana Souza Uzeloto, Franciele Marques Vanderlei, Dionei Ramos, Ercy Mara Cipulo Ramos
Investigating modifications to participant information materials to improve recruitment into a large randomized trial
Richard Haynes, Fang Chen, Elizabeth Wincott, Rejive Dayanandan, Michael J. Lay, Sarah Parish, Louise Bowman, Martin J. Landray, Jane Armitage, R. Collins, C. Baigent, Z. Chen, Y. Chen, L. Jiang, T. Pedersen, K. Rahimi, J. Tobert, P. Sleight, D. Simpson, A. Baxter, C. Bray, G. van Leijenhorst, Y. Mitchel, O. Kuznetsova, Richard Haynes, Fang Chen, Elizabeth Wincott, Rejive Dayanandan, Michael J. Lay, Sarah Parish, Louise Bowman, Martin J. Landray, Jane Armitage
Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial
Devin S. McCaskell, Alexander J. Molloy, Laura Childerhose, F. Aileen Costigan, Julie C. Reid, Magda McCaughan, France Clarke, Deborah J. Cook, Jill C. Rudkowski, Christopher Farley, Tim Karachi, Bram Rochwerg, Anastasia Newman, Alison Fox-Robichaud, Margaret S. Herridge, Vincent Lo, Deanna Feltracco, Karen EA Burns, Rebecca Porteous, Andrew J. E. Seely, Ian M. Ball, Amy Seczek, Michelle E. Kho
Effects of vitamin D and omega-3 fatty acids co-supplementation on inflammatory biomarkers, tumor marker CEA, and nutritional status in patients with colorectal cancer: a study protocol for a double blind randomized controlled trial
Fatemeh Haidari, Behnaz Abiri, Masood Iravani, Seyed-Mohsen Razavi, Parvin Sarbakhsh, Kambiz Ahmadi-Angali, Mohammadreza Vafa
The effect of antibiotics on post-adenotonsillectomy morbidity in Tanzanian children: study protocol for a randomized, double-blind, placebo-controlled trial
Denis R. Katundu, Peter S. Shija, Baltazari Nyombi, Hadija Semvua, Fieke K. Oussoren, Niels van Heerbeek
A pragmatic pilot phase II randomised controlled trial of prothrombin complex concentrates (PCC) versus fresh frozen plasma (FFP) in adult patients who are undergoing heart surgery (PROPHESY)
Laura Green, Neil Roberts, Jackie Cooper, Jane Field, Ravi Gill, Andrew Klein, Seema Agarwal, Simon Stanworth, Atholl Johnston, Vivienne Monk, Ben O’Brien
Acupuncture for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a randomized controlled trial
Jing Guo, Siyi Yu, Chunhong Liu, Guiling Wang, Bin Li
Overcoming challenges to data quality in the ASPREE clinical trial
Jessica E. Lockery, Taya A. Collyer, Christopher M. Reid, Michael E. Ernst, David Gilbertson, Nino Hay, Brenda Kirpach, John J. McNeil, Mark R. Nelson, Suzanne G. Orchard, Kunnapoj Pruksawongsin, Raj C. Shah, Rory Wolfe, Robyn L. Woods
KONTAKT© for Australian adolescents on the autism spectrum: protocol of a randomized control trial
Bahareh Afsharnejad, Marita Falkmer, Melissa H. Black, Tasha Alach, Fabian Lenhard, Anna Fridell, Christina Coco, Kelly Milne, Nigel T. M. Chen, Sven Bölte, Sonya Girdler
Fecal microbiome as determinant of the effect of diet on colorectal cancer risk: comparison of meat-based versus pesco-vegetarian diets (the MeaTIc study)
Francesco Sofi, Monica Dinu, Giuditta Pagliai, Fabrice Pierre, Francoise Gueraud, Jildau Bowman, Philippe Gerard, Vincenzo Longo, Lisa Giovannelli, Giovanna Caderni, Carlotta de Filippo
Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial
Taoying Lu, Huiyan Zhang, Lingjia Yin, Jianxiong Cai, Meiling Li, Lin Dai, Conghao Zhu, Yongping Zhang, Feng Xiang, Li Wang, Lu Li, Lixin Wang, Darong Wu
Principles and procedures for data and safety monitoring in pragmatic clinical trials
Gregory E. Simon, Susan M. Shortreed, Rebecca C. Rossom, Robert B. Penfold, Jo Ann M. Sperl-Hillen, Patrick O’Connor
COMMENCE trial (Comparing hypOtherMic teMperaturEs duriNg hemiarCh surgEry): a randomized controlled trial of mild vs moderate hypothermia on patient outcomes in aortic hemiarch surgery with anterograde cerebral perfusion
Habib Jabagi, George Wells, Munir Boodhwani
Cognitive-behavioral intervention via interactive multimedia online video game for active aging: study protocol for a randomized controlled trial
Fernando L. Vázquez, Ángela J. Torres, Patricia Otero, Vanessa Blanco, Lara López, Antonio García-Casal, Manuel Arrojo
Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): a randomised controlled open-label non-inferiority trial of duration of systemic antibiotics in adults with orthopaedic infection treated operatively with local antibiotic therapy
Maria Dudareva, Michelle Kümin, Werner Vach, Klaus Kaier, Jamie Ferguson, Martin McNally, Matthew Scarborough
An adaptive two-arm clinical trial using early endpoints to inform decision making: design for a study of sub-acromial spacers for repair of rotator cuff tendon tears
Nick Parsons, Nigel Stallard, Helen Parsons, Philip Wells, Martin Underwood, James Mason, Andrew Metcalfe
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 Swendeman, Kathryn C. Kaplan, Siyan Yi
ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction
Yen-I Chen, Kashi Callichurn, Avijit Chatterjee, Etienne Desilets, Donnellan Fergal, Nauzer Forbes, Ian Gan, Sana Kenshil, Mouen A. Khashab, Rastislav Kunda, Eric Lam, Gary May, Rachid Mohamed, Jeff Mosko, Sarto C. Paquin, Anand Sahai, Gurpal Sandha, Christopher Teshima, Alan Barkun, Jeffrey Barkun, Ali Bessissow, Kristina Candido, Myriam Martel, Corey Miller, Kevin Waschke, George Zogopoulos, Clarence Wong
Psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms, the CORPUS trial: study protocol for a randomised controlled trial
Margreet S. H. Wortman, Johannes C. van der Wouden, Janneke P. C. Grutters, Bart Visser, Willem J. J. Assendelft, Henriëtte E. van der Horst, Tim C. olde Hartman
Statistical analysis plan for the Dex-CSDH trial: a randomised, double-blind, placebo-controlled trial of a 2-week course of dexamethasone for adult patients with a symptomatic chronic subdural haematoma
Annabel Allison, Ellie Edlmann, Angelos G. Kolias, Carol Davis-Wilkie, Harry Mee, Eric P. Thelin, Carole Turner, Peter J. Hutchinson, Simon Bond
GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial
Valentin Garyga, Florian Pochelu, Béatrice Thivichon-Prince, Walid Aouini, Julie Santamaria, France Lambert, Delphine Maucort-Boulch, Francois Gueyffier, Kerstin Gritsch, Brigitte Grosgogeat
Measurement training and feedback system for implementation of evidence-based treatment for adolescent externalizing problems: protocol for a randomized trial of pragmatic clinician training
Aaron Hogue, Molly Bobek, Alexandra MacLean, Nicole Porter, Amanda Jensen-Doss, Craig E. Henderson
Electronic health record nested pragmatic randomized controlled trial of a reminder system for serum lithium level monitoring in patients with mood disorder: KONOTORI study protocol
Tomotsugu Seki, Morio Aki, Hirotsugu Kawashima, Tomotaka Miki, Shiro Tanaka, Koji Kawakami, Toshi A. Furukawa
Acupoint transcutaneous electrical nerve stimulation in hospitalized COPD patients with severe dyspnoea: study protocol for a randomized controlled trial
Carles Fernández-Jané, Jordi Vilaró
Criteria for site selection in industry-sponsored clinical trials: a survey among decision-makers in biopharmaceutical companies and clinical research organizations
Tilde Dombernowsky, Merete Haedersdal, Ulrik Lassen, Simon Francis Thomsen
Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial
Aisha Shafayat, Emese Csipke, Lucy Bradshaw, Georgina Charlesworth, Florence Day, Phuong Leung, Esme Moniz-Cook, Alan A. Montgomery, Steve Morris, Gail Mountain, Reuben Ogollah, Kirsty Sprange, Lauren Yates, Martin Orrell
Efficacy and safety of dexmedetomidine for prevention of withdrawal syndrome in the pediatric intensive care unit: protocol for an adaptive, multicenter, randomized, double-blind, placebo-controlled, non-profit clinical trial
Maria Cristina Mondardini, Francesca Sperotto, Marco Daverio, Fabio Caramelli, Dario Gregori, Maria Francesca Caligiuri, Francesca Vitale, Maria Teresa Cecini, Marco Piastra, Aldo Mancino, Andrea Pettenazzo, Giorgio Conti, Angela Amigoni
Improving the relevance of randomised trials to primary care: a qualitative study investigating views towards pragmatic trials and the PRECIS-2 tool
Gordon Forbes, Kirsty Loudon, Megan Clinch, Stephanie J. C. Taylor, Shaun Treweek, Sandra Eldridge
Effectiveness of an online self-management tool, OPERAS (an On-demand Program to EmpoweR Active Self-management), for people with rheumatoid arthritis: a research protocol
Johnathan Tam, Diane Lacaille, Teresa Liu-Ambrose, Chris Shaw, Hui Xie, Catherine L. Backman, John M. Esdaile, Kimberly Miller, Robert Petrella, Linda C. Li
A randomized trial of a specialist palliative care intervention for patients undergoing surgery for cancer: rationale and design of the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial
Myrick C. Shinall Jr, Aimee Hoskins, Alexander T. Hawkins, Christina Bailey, Alaina Brown, Rajiv Agarwal, Maria C. Duggan, Laura M. Beskow, Vyjeyanthi S. Periyakoil, David F. Penson, Ryan T. Jarrett, Rameela Chandrasekhar, E. Wesley Ely
Budgeting of non-commercial clinical trials: development of a budget tool by a public funding agency
Hilde Nevens, Jillian Harrison, France Vrijens, Leen Verleye, Nelle Stocquart, Elisabeth Marynen, Frank Hulstaert
Landiolol, an ultra-short acting beta-1 blocker, for preventing postoperative lung cancer recurrence: study protocol for a phase III, multicenter randomized trial with two parallel groups of patients
Haruko Yamamoto, Toshimitsu Hamasaki, Kaori Onda, Takashi Nojiri, Masato Aragaki, Nao Horie, Norihiro Sato, Yasuhiro Hida
Correction to: The life expectancy of patients with metabolic syndrome after weight loss: study protocol for a randomized clinical trial (LIFEXPE-RT)
Oral Ospanov, Galymzhan Yeleuov, Irina Kadyrova, Farida Bekmurzinova
Protocol for a partially nested randomized controlled trial to evaluate the effectiveness of the Scleroderma Patient-centered Intervention Network Support Group Leader EDucation (SPIN-SSLED) Program
Brett D. Thombs, Kylene Aguila, Laura Dyas, Marie-Eve Carrier, Claire Fedoruk, Linda Horwood, Mara Cañedo-Ayala, Maureen Sauvé, Linda Kwakkenbos, Vanessa L. Malcarne, Ghassan El-Baalbaki, Sandra Peláez, Kerri Connolly, Marie Hudson, Robert W. Platt, Stephen Elrod, Catherine Fortuné, Karen Gottesman, Karen Nielsen, Ken Rozee, Amy Gietzen, Michelle Richard, Nancy Stephens
Pulmonary Metastasectomy versus Continued Active Monitoring in Colorectal Cancer (PulMiCC): a multicentre randomised clinical trial
Tom Treasure, Vern Farewell, Fergus Macbeth, Kathryn Monson, Norman R Williams, Chris Brew-Graves, Belinda Lees, Olivia Grigg, Lesley Fallowfield, Tom Treasure, Sion Barnard, Tim Batchelor, Chris Brew-Graves, Aman Coonar, Brian Davidson, Joel Dunning, John Edwards, Lesley Fallowfield, Vern Farewell, Simon Kendall, Olivia Grigg, Simon Grumett, Jurjees Hasan, Pauline Leonard, Belinda Lees, Eric Lim, Fergus Macbeth, Adrian Marchbank, Kathryn Monson, Apostolos Nakas, Ingrid Potyka, Mike Shackcloth, Bina Shah, David Tsang, Stelios Vakis, Norman R. Williams
Retraining automatic action tendencies for smoking using mobile phone-based approach-avoidance bias training: A study protocol for a randomized controlled study
Alla Machulska, Kristian Kleinke, Tanja Joan Eiler, Armin Grünewald, Rainer Brück, Katharina Jahn, Björn Niehaves, Carl Friedrich Gethmann, Tim Klucken
Correction to: iHIVARNA phase IIa, a randomized, placebo-controlled, double-blinded trial to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy
Wesley de Jong, Joeri Aerts, Sabine Allard, Christian Brander, Jozefien Buyze, Eric Florence, Eric van Gorp, Guido Vanham, Lorna Leal, Beatriz Mothe, Kris Thielemans, Montse Plana, Félipe Garcia, Rob Gruters
MultiTex RCT – a multifaceted intervention package for protection against cotton dust exposure among textile workers – a cluster randomized controlled trial in Pakistan: study protocol
Asaad Ahmed Nafees, Sara De Matteis, Muhammad Masood Kadir, Peter Burney, David Coggon, Sean Semple, Paul Cullinan
ELECtric Tibial nerve stimulation to Reduce Incontinence in Care homes: protocol for the ELECTRIC randomised trial
J. Booth, L. Aucott, S. Cotton, C. Goodman, S. Hagen, D. Harari, M. Lawrence, A. Lowndes, L. Macaulay, G. MacLennan, H. Mason, D. McClurg, J. Norrie, C. Norton, C. O’Dolan, D. A. Skelton, C. Surr, S. Treweek
Functional electrical stimulation-assisted cycle ergometry in the critically ill: protocol for a randomized controlled trial
Petr Waldauf, Jan Gojda, Tomáš Urban, Natália Hrušková, Barbora Blahutová, Marie Hejnová, Kateřina Jiroutková, Michal Fric, Pavel Jánský, Jana Kukulová, Francis Stephens, Kamila Řasová, František Duška
Efficacy and safety of tetramethylpyrazine phosphate on pulmonary hypertension: study protocol for a randomized controlled study
Yuqin Chen, Wenjun He, Haiping Ouyang, Chunli Liu, Cheng Hong, Tao Wang, Kai Yang, Wenju Lu, Jian Wang
The Artificial Kidney Initiation in Kidney Injury 2 (AKIKI2): study protocol for a randomized controlled trial
Stéphane Gaudry, David Hajage, Laurent Martin-Lefevre, Guillaume Louis, Sébastien Moschietto, Dimitri Titeca-Beauport, Béatrice La Combe, Bertrand Pons, Nicolas de Prost, Sébastien Besset, Alain Combes, Adrien Robine, Marion Beuzelin, Julio Badie, Guillaume Chevrel, Jean Reignier, Julien Bohé, Elisabeth Coupez, Nicolas Chudeau, Saber Barbar, Christophe Vinsonneau, Jean-Marie Forel, Didier Thevenin, Eric Boulet, Karim Lakhal, Nadia Aissaoui, Steven Grange, Marc Leone, Guillaume Lacave, Saad Nseir, Florent Poirson, Julien Mayaux, Karim Asehnoune, Guillaume Geri, Kada Klouche, Guillaume Thiery, Laurent Argaud, Jean-Damien Ricard, Jean-Pierre Quenot, Didier Dreyfuss
Reduction of corticosteroid use in outpatient treatment of exacerbated COPD - Study protocol for a randomized, double-blind, non-inferiority study, (The RECUT-trial)
Pascal Urwyler, Maria Boesing, Kristin Abig, Marco Cattaneo, Thomas Dieterle, Andreas Zeller, Herbert Bachler, Stefan Markun, Oliver Senn, Christoph Merlo, Stefan Essig, Elke Ullmer, Jonas Rutishauser, Macé M Schuurmans, Joerg Daniel Leuppi
Using the Multiphase Optimization Strategy (MOST) framework to test intervention delivery strategies: a study protocol
Sarabeth Broder-Fingert, Jocelyn Kuhn, Radley Christopher Sheldrick, Andrea Chu, Lisa Fortuna, Megan Jordan, Dana Rubin, Emily Feinberg
Reporting quality and adherence of randomized controlled trials about statins and/or fibrates for diabetic retinopathy to the CONSORT checklist
Vânia Mozetic, Letícia Leonel, Rafael Leite Pacheco, Carolina de Oliveira Cruz Latorraca, Taís Guimarães, Patricia Logullo, Rachel Riera
A systematic review identifying common data items in neonatal trials and assessing their completeness in routinely recorded United Kingdom national neonatal data
Sena Jawad, Neena Modi, A. Toby Prevost, Chris Gale
Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine
Ruth Knight, Lisa Poulton, Louise H. Strickland, Thomas W. Hamilton, David Beard, Jonathan Cook, Susan J. Dutton, Jose Leal, Sarah Lamb, Cushla Cooper, Karen L. Barker, David W. Murray, Hemant G. Pandit
Decreasing postoperative cognitive deficits after heart surgery: protocol for a randomized controlled trial on cognitive training
Marius Butz, Jasmin El Shazly, Gebhard Sammer, Marlene Tschernatsch, Sabrina Kastaun, Mesut Yenigün, Tobias Braun, Manfred Kaps, Andreas Böning, Ulrike Puvogel, Georg Bachmann, Thomas Mengden, Markus Schönburg, Tibo Gerriets, Martin Juenemann
Determining the effects of exercise after smoking cessation therapy completion on continuous abstinence from smoking: Japanese study protocol
Yuka Ozaki, Maki Komiyama, Kenji Ueshima, Hiroyasu Iso, Satoko Sakata, Ayumi Morino, Mitsuyoshi Takahara, Satoshi Noguchi, Yoshihiro Kuwabara, Yuko Takahashi, Koji Hasegawa
Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial
Hailong Zhang, Jiansheng Li, Xueqing Yu, Suyun Li, Haifeng Wang, Huanrong Ruan, Yimei Si, Yang Xie, Minghang Wang
Efficacy of chlorthalidone and hydrochlorothiazide in combination with amiloride in multiple doses on blood pressure in patients with primary hypertension: a protocol for a factorial randomized controlled trial
Vítor Magnus Martins, Lucas Helal, Filipe Ferrari, Leonardo Grabinski Bottino, Sandra Costa Fuchs, Flávio Danni Fuchs
Hernia reduction following laparotomy using small stitch abdominal wall closure with and without mesh augmentation (the HULC trial): study protocol for a randomized controlled trial
Patrick Heger, Manuel Feißt, Johannes Krisam, Christina Klose, Colette Dörr-Harim, Solveig Tenckhoff, Markus W. Büchler, Markus K. Diener, André L. Mihaljevic
Topical sirolimus 0.1% for treating cutaneous microcystic lymphatic malformations in children and adults (TOPICAL): protocol for a multicenter phase 2, within-person, randomized, double-blind, vehicle-controlled clinical trial
Sophie Leducq, Agnès Caille, Sébastien Barbarot, Nathalie Bénéton, Didier Bessis, Olivia Boccara, Anne-Claire Bursztejn, Christine Chiaverini, Anne Dompmartin, Catherine Droitcourt, Valérie Gissot, Dominique Goga, Laurent Guibaud, Denis Herbreteau, Anne Le Touze, Christine Léauté-Labrèze, Gérard Lorette, Stéphanie Mallet, Ludovic Martin, Juliette Mazereeuw-Hautier, Alice Phan, Patrice Plantin, Isabelle Quéré, Pierre Vabres, Hélène Bourgoin, Bruno Giraudeau, Annabel Maruani
Effectiveness and cost-effectiveness of Improving clinicians’ diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): study protocol for a cluster randomised controlled trial
Rafa Ruiz, Ana Moragas, Marta Trapero-Bertran, Antoni Sisó, Anna Berenguera, Glòria Oliva, Alícia Borràs-Santos, Ana García-Sangenís, Jaume Puig-Junoy, Josep M. Cots, Rosa Morros, Toni Mora, Anna Lanau-Roig, Ramon Monfà, Amelia Troncoso, Rosa M. Abellana, Pau Gálvez, Laura Medina-Perucha, Lars Bjerrum, Isabel Amo, Nieves Barragán, Carl Llor
Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE)
Karina Giassi, Vanessa Piccoli, Ticiana da Costa Rodrigues, Renato Gorga Bandeira de Mello
Community interventions to prevent violence against women and girls in informal settlements in Mumbai: the SNEHA-TARA pragmatic cluster randomised controlled trial
Nayreen Daruwalla, Unnati Machchhar, Shanti Pantvaidya, Vanessa D’Souza, Lu Gram, Andrew Copas, David Osrin
Behavioral and psychological impact of returning breast density results to Latinas: study protocol for a randomized clinical trial
Bhavika K. Patel, Jennifer L. Ridgeway, Karthik Ghosh, Deborah J. Rhodes, Bijan Borah, Sarah Jenkins, Vera J. Suman, Aaron Norman, Matt Jewett, Davinder Singh, Celine M. Vachon, Carmen Radecki Breitkopf
Right Dose Right Now: bedside data-driven personalized antibiotic dosing in severe sepsis and septic shock — rationale and design of a multicenter randomized controlled superiority trial
Luca F. Roggeveen, Lucas M. Fleuren, Tingjie Guo, Patrick Thoral, Harm Jan de Grooth, Eleonora L. Swart, Thomas L. T. Klausch, Peter H. J. van der Voort, Armand R. J. Girbes, Rob J. Bosman, Paul W. G. Elbers
Detailed statistical analysis plan for the SafeBoosC III trial: a multinational randomised clinical trial assessing treatment guided by cerebral oxygenation monitoring versus treatment as usual in extremely preterm infants
Mathias Lühr Hansen, Adelina Pellicer, Christian Gluud, Eugene Dempsey, Jonathan Mintzer, Simon Hyttel-Sorensen, Anne Marie Heuchan, Cornelia Hagmann, Gabriel Dimitriou, Gerhard Pichler, Gunnar Naulaers, Guoqiang Cheng, Ana Vilan, Jakub Tkaczyk, Karen B. Kreutzer, Monica Fumagalli, Olivier Claris, Siv Fredly, Tomasz Szczapa, Theis Lange, Janus Christian Jakobsen, Gorm Greisen
A 2 × 2 factorial, randomised, open-label trial to determine the clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care over 52 weeks in adults with bronchiectasis: a protocol for the CLEAR clinical trial
Judy Martina Bradley, Rohan Anand, Brenda O’Neill, Kathryn Ferguson, Mike Clarke, Mary Carroll, James Chalmers, Anthony De Soyza, Jamie Duckers, Adam T. Hill, Michael R. Loebinger, Fiona Copeland, Evie Gardner, Christina Campbell, Ashley Agus, Alistair McGuire, Roisin Boyle, Fionnuala McKinney, Naomi Dickson, Danny F. McAuley, Stuart Elborn, Damian Downey, Martin Kelly, John Hurst, Muhammad Anwar, Rory Convery, Timothy Gatheral, Stephen Scott, Anita Sullivan, William Flight, Alina Ionescu
Efficacy of Behavioral Experiments in Cognitive Therapy for Social Anxiety Disorder: Study protocol for a randomized controlled trial
Celina Clément, Jihong Lin, Ulrich Stangier
Regorafenib plus FOLFIRI with irinotecan dose escalated according to uridine diphosphate glucuronosyltransferase 1A1genotyping in previous treated metastatic colorectal cancer patients:study protocol for a randomized controlled trial
Cheng-Jen Ma, Tsung-Kun Chang, Hsiang-Lin Tsai, Wei-Chih Su, Ching-Wen Huang, Yung-Sung Yeh, Yu-Tang Chang, Jaw-Yuan Wang
Evaluation of an International Classification of Functioning, Disability and Health-based rehabilitation for thermal burn injuries: a prospective non-randomized design
Hubert Neubauer, Annette Stolle, Sabine Ripper, Felix Klimitz, Hans Ziegenthaler, Mareike Strupat, Ulrich Kneser, Leila Harhaus
Comparative Effectiveness of Local Application of Chlorhexidine Gluconate, Mupirocin Ointment, and Normal Saline for the Prevention of Peritoneal Dialysis-related Infections (COSMO-PD Trial): a multicenter randomized, double-blind, controlled protocol
Surapon Nochaiwong, Chidchanok Ruengorn, Kajohnsak Noppakun, Setthapon Panyathong, Phongsak Dandecha, Manish M. Sood, Chalermpong Saenjum, Ratanaporn Awiphan, Sasithorn Sirilun, Pajaree Mongkhon, Wilaiwan Chongruksut, Kednapa Thavorn
The effect of an educational program for pregnant women to prevent allergic diseases in infants: study protocol for a randomized controlled trial
Rie Nakamura, Nao Ishiguro, Eiji Naru, Yukiko Ishitsuka, Masato Nakade, Yoko Nezu
Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial
De Jin, Wen-Jing Huang, Xiang Meng, Fan Yang, Qi Bao, Mei-zhen Zhang, Ya-nan Yang, Qing Ni, Feng-Mei Lian, Xiao-Lin Tong
A disorder-specific group cognitive behavior therapy for social anxiety disorder in adolescents: study protocol for a randomized controlled study
Nanna Fensman Lassen, Esben Hougaard, Kristian Bech Arendt, Mikael Thastum
Non-placement versus placement of a drainage tube around the cervical anastomosis in McKeown esophagectomy: study protocol for a randomized controlled trial
Taro Oshikiri, Gosuke Takiguchi, Susumu Miura, Nobuhisa Takase, Hiroshi Hasegawa, Masashi Yamamoto, Shingo Kanaji, Kimihiro Yamashita, Yoshiko Matsuda, Takeru Matsuda, Tetsu Nakamura, Satoshi Suzuki, Yoshihiro Kakeji
Rapid Access to Contrast-Enhanced spectral mammogRaphy in women recalled from breast cancer screening: the RACER trial study design
L. M. F. H. Neeter, I. P. L. Houben, P. J. Nelemans, T. J. A. Van Nijnatten, R. M. Pijnappel, C. Frotscher, M. Osinga-de Jong, F. Sanders, T. Van Dalen, H. P. J. Raat, B. A. B. Essers, J. E. Wildberger, M. L. Smidt, M. B. I. Lobbes
Evaluation of the efficacy of simplified nutritional instructions from physicians on dietary salt restriction for patients with type 2 diabetes mellitus consuming excessive salt: protocol for a randomized controlled trial
Emi Ushigome, Chikako Oyabu, Makoto Shiraishi, Nobuko Kitagawa, Aya Kitae, Keiko Iwai, Hidetaka Ushigome, Isao Yokota, Masahide Hamaguchi, Masahiro Yamazaki, Michiaki Fukui
Preliminary effect and feasibility of physiotherapy with strength training and protein-rich nutritional supplement in combination with anabolic steroids in cross-continuum rehabilitation of patients with hip fracture: protocol for a blinded randomized controlled pilot trial (HIP-SAP1 trial)
Signe Hulsbæk, Ilija Ban, Tobias Kvanner Aasvang, Jens-Erik Beck Jensen, Henrik Kehlet, Nicolai Bang Foss, Thomas Bandholm, Morten Tange Kristensen
The ethical challenges raised in the design and conduct of pragmatic trials: an interview study with key stakeholders
Stuart G. Nicholls, Kelly Carroll, Merrick Zwarenstein, Jamie C. Brehaut, Charles Weijer, Spencer P. Hey, Cory E. Goldstein, Ian D. Graham, Jeremy M. Grimshaw, Joanne E. McKenzie, Dean A. Fergusson, Monica Taljaard
Comparing the effect of auricular acupressure and body acupressure on pain and duration of the first stage of labor: study protocol for a randomized controlled trial
Zainab Alimoradi, Farideh Kazemi, Mahboubeh Valiani, Maryam Gorji
Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? Protocol for a feasibility study
Oghenekome Gbinigie, Julie Allen, Anne-Marie Boylan, Alastair Hay, Carl Heneghan, Michael Moore, Nicola Williams, Chris Butler
Effects of aerobic interval training on glucose tolerance in children and adolescents with cystic fibrosis: a randomized trial protocol
Karolinne Souza Monteiro, Matheus de Paiva Azevedo, Lucas Menescal Jales, Fernanda Elizabeth Pereira da Silva, Ricardo Fernando Arrais, Karla Morganna Pereira Pinto de Mendonça
Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial
Ulrich Reininghaus, Annelie Klippel, Henrietta Steinhart, Thomas Vaessen, Martine van Nierop, Wolfgang Viechtbauer, Tim Batink, Zuzana Kasanova, Evelyne van Aubel, Ruud van Winkel, Machteld Marcelis, Therese van Amelsvoort, Mark van der Gaag, Lieuwe de Haan, Inez Myin-Germeys
Correction to: Efficiency and safety of renal denervation via cryoablation (Cryo-RDN) in Chinese patients with uncontrolled hypertension: study protocol for a randomized controlled trial
Han Chen, Meng Ji, Yi Zhang, Yawei Xu, Lingjuan Qiao, Li Shen, Junbo Ge
Correction to: A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial
Pernille Langer Soendergaard, Mia Moth Wolffbrandt, Fin Biering-Sørensen, Malin Nordin, Trine Schow, Juan Carlos Arango-Lasprilla, Anne Norup
The BrainACT study: acceptance and commitment therapy for depressive and anxiety symptoms following acquired brain injury: study protocol for a randomized controlled trial
Johanne Rauwenhoff, Frenk Peeters, Yvonne Bol, Caroline Van Heugten
Mindfulness-based cognitive therapy and cognitive behavioral therapy for chronic pain in multiple sclerosis: a randomized controlled trial protocol
Dawn M. Ehde, Kevin N. Alschuler, Melissa A. Day, Marcia A. Ciol, Makena L. Kaylor, Jennifer K. Altman, Mark P. Jensen
Self-care for head and neck cancer survivors with lymphedema and fibrosis: study protocol for a randomized controlled trial
Jie Deng, Mary S. Dietrich, Barbara Murphy
Efficacy, safety, and cost-effectiveness analysis of adjuvant herbal medicine treatment, Palmijihwang-hwan, for chronic low back pain: a study protocol for randomized, controlled, assessor-blinded, multicenter clinical trial
Won-Suk Sung, Sae-Rom Jeon, Ye-Jin Hong, Tae-Hun Kim, Seungwon Shin, Hyun-Jong Lee, Byung-Kwan Seo, Yeon-Cheol Park, Eun-Jung Kim, Dong-Woo Nam
Use of a smartphone app combined with gamification to increase the level of physical activity of adults and older adults: protocol of a sequential multiple assignment randomized trial
Maria do Socorro Morais Pereira Simões, Bárbara de Barros Gonze, Neli Leite Proença, Vinicius Tonon Lauria, Vinícius Demarchi Silva Terra, Ricardo da Costa Padovani, Victor Zuniga Dourado
Virtual reality as an adjunct to anesthesia in the operating room
Adeel Faruki, Thy Nguyen, Samantha Proeschel, Nadav Levy, Jessica Yu, Victoria Ip, Ariel Mueller, Valerie Banner-Goodspeed, Brian O’Gara
Evaluation of bladder stimulation as a non-invasive technique for urine collection to diagnose urinary tract infection in infants under 6 months: a randomized multicenter study (“EE-Sti.Ve.N”)
D. Demonchy, C. Ciais, E. Fontas, E. Berard, J. Bréaud, P. S. Rohrlich, F. Dubos, C. Fortier, J. Desmontils, A. L. Hérisse, D. Donzeau, H. Haas, A. Tran
Two interventions to treat pain disorders and post-traumatic symptoms among Syrian refugees: protocol for a randomized controlled trial
Wegdan Hasha, Lars T. Fadnes, Jannicke Igland, Rolf Vårdal, Line Merete Giusti, Elisabeth Marie Strømme, Jasmin Haj-Younes, Unni Heltne, Bernadette N. Kumar, Esperanza Diaz
Manual therapy as a prophylactic treatment for migraine: design of a randomized controlled trial
Andreas Leonard Amons, Rene Franciscus Castien, Johannes C. van der Wouden, Willem De Hertogh, Joost Dekker, Henriëtte Eveline van der Horst
An adjunctive human-animal interaction intervention for veterans with PTSD: study protocol for a randomized controlled trial
Anouk L. Grubaugh, Ursula S. Myers, Stephanie M. Keller, Bethany C. Wangelin, Brian E. Lozano, Peter W. Tuerk
Impact of human papillomavirus (HPV) self-collection on subsequent cervical cancer screening completion among under-screened US women: MyBodyMyTest-3 protocol for a randomized controlled trial
Lisa P. Spees, Andrea C. Des Marais, Stephanie B. Wheeler, Michael G. Hudgens, Sarah Doughty, Noel T. Brewer, Jennifer S. Smith
Effects of perioperative transcutaneous electrical acupoint stimulation on monocytic HLA-DR expression in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass: study protocol for a double-blind randomized controlled trial
Wen-ting Chen, Jin-feng Wei, Lan Wang, Deng-wen Zhang, Wei Tang, Jian Wang, Yue Yong, Jing Wang, Ya-lan Zhou, Lan Yuan, Guo-qiang Fu, Sheng Wang, Jian-gang Song
Teacher Anxiety Program for Elementary Students (TAPES): intervention development and proposed randomized controlled trial
Golda S. Ginsburg, Jeffrey E. Pella, Kate Piselli, Grace Chan
Nurse-led care versus physician-led care in the management of rheumatoid arthritis and psoriatic arthritis (StaerkeR): study protocol for a multi-center randomized controlled trial
Anna Mai, Jürgen Braun, Jens-Peter Reese, Benjamin Westerhoff, Ulrike Trampisch, Renate Klaassen-Mielke, Nina Timmesfeld, Hans J. Trampisch, Dietmar Krause
Can selenium deficiency in Malawi be alleviated through consumption of agro-biofortified maize flour? Study protocol for a randomised, double-blind, controlled trial
Edward J. M. Joy, Alexander A. Kalimbira, Dawd Gashu, Elaine L. Ferguson, Joanna Sturgess, Alan D. Dangour, Leonard Banda, Gabriella Chiutsi-Phiri, Elizabeth H. Bailey, Simon C. Langley-Evans, R. Murray Lark, Kate Millar, Scott D. Young, Limbanazo Matandika, Joseph Mfutso-Bengo, John C. Phuka, Felix P. Phiri, Jellita Gondwe, E. Louise Ander, Nicola M. Lowe, Patson C. Nalivata, Martin R. Broadley, Elizabeth Allen
A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial
Pamela Martyn-Nemeth, Jennifer Duffecy, Laurie Quinn, Chang Park, Dan Mihailescu, Sue Penckofer
Using an incentive spirometer reduces pulmonary complications in patients with traumatic rib fractures: a randomized controlled trial
Shao-Kai Sum, Ya-Chuan Peng, Shun-Ying Yin, Pin-Fu Huang, Yao-Chang Wang, Tzu-Ping Chen, Heng-Hsin Tung, Chi-Hsiao Yeh
Zwakala Ndoda: a cluster and individually randomized trial aimed at improving testing, linkage, and adherence to treatment for hard-to reach men in KwaZulu-Natal, South Africa
Heidi van Rooyen, Tawanda Makusha, Phillip Joseph, Thulani Ngubane, Michal Kulich, Michael Sweat, Thomas Coates
The effect of co supplementation of omega-3 and vitamin D on cardio metabolic risk factors and psychological distress in reproductive-aged women with prediabetes and hypovitaminosis D: a study protocol for a randomized controlled trial
Masoumeh Rajabi-Naeeni, Mahrokh Dolatian, Mostafa Qorbani, Amir Abbas Vaezi
Evaluating the therapeutic efficacy of the Chinese herbal medicine Yishen Tongbi decoction in patients with active rheumatoid arthritis: protocol for a randomized, controlled, noninferiority trial
Lianyu Zhao, Meilin Li, Yanping Xu, Lijuan Liu, Mingying Zhang, Guangxing Chen
Efficacy of Bimin decoction for patients with perennial allergic rhinitis: an open-label non-inferiority randomized controlled trial
Jingyi Zhao, Xinyu Yan, Jianqing Gai, Jinshuai Han, Hong Zhang, Hui Luo, Shaoting Huang, Junge Wang
Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting
Gwenllian Moody, Katy Addison, Rebecca Cannings-John, Julia Sanders, Carolyn Wallace, Michael Robling
Transcranial direct current stimulation in management of pain, mood, functionality, and quality of life in patients undergoing hemodialysis: a study protocol for a double-blind controlled randomized trial
Artur Quintiliano, Tayanne Oehmen, Gianna Mastroianni Kirsztajn, Rodrigo Pegado
INtervention for Cognitive Reserve Enhancement in delaying the onset of Alzheimer’s Symptomatic Expression (INCREASE), a randomized controlled trial: rationale, study design, and protocol
Daniela C. Moga, Brooke F. Beech, Erin L. Abner, Frederick A. Schmitt, Riham H. El Khouli, Ashley I. Martinez, Lynne Eckmann, Mark Huffmyer, Rosmy George, Gregory A. Jicha
Testing effectiveness of the revised Cape Town modified early warning and SBAR systems: a pilot pragmatic parallel group randomised controlled trial
Una Kyriacos, Debora Burger, Sue Jordan
Effects of acupuncture on the hypothalamus-pituitary-adrenal axis in chronic insomnia patients: a study protocol for a randomized controlled trial
Chengyong Liu, Shiyu Zheng, Wenzhong Wu, Xiaoqiu Wang, Shan Qin, Yanan Zhao, Hanqing Xi, Qingyun Wan
Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial
Mathias Lühr Hansen, Adelina Pellicer, Christian Gluud, Eugene Dempsey, Jonathan Mintzer, Simon Hyttel-Sørensen, Anne Marie Heuchan, Cornelia Hagmann, Ebru Ergenekon, Gabriel Dimitriou, Gerhard Pichler, Gunnar Naulaers, Guoqiang Cheng, Hercilia Guimarães, Jakub Tkaczyk, Karen B. Kreutzer, Monica Fumagalli, Olivier Claris, Petra Lemmers, Siv Fredly, Tomasz Szczapa, Topun Austin, Janus Christian Jakobsen, Gorm Greisen
Combining physical therapy and cognitive behavioral therapy techniques to improve balance confidence and community participation in people with unilateral transtibial amputation who use lower limb prostheses: a study protocol for a randomized sham-control clinical trial
McKenzie O. Bourque, Kristin L. Schneider, John E. Calamari, Christopher Reddin, Aaron Stachowiak, Matthew J. Major, Chad Duncan, Ranjini Muthukrishnan, Noah J. Rosenblatt
Results and lessons learnt from a randomized controlled trial: prophylactic treatment of vestibular migraine with metoprolol (PROVEMIG)
Otmar Bayer, Christine Adrion, Amani Al Tawil, Ulrich Mansmann, Michael Strupp, Michael Strupp, Hans-Christoph Diener, Hubert Löwenheim, Thomas Lempert, Wolfgang Heide, Holger Rambold
Internet-based interpersonal psychotherapy for stress, anxiety, and depression in prenatal women: study protocol for a pilot randomized controlled trial
Katherine S. Bright, Muhammad Kashif Mughal, Abdul Wajid, Marie Lane-Smith, Lindsay Murray, Nicola Roy, Sander Veldhuyzen Van Zanten, Deborah A. Mcneil, Scott Stuart, Dawn Kingston
A randomised controlled trial of an exercise intervention promoting activity, independence and stability in older adults with mild cognitive impairment and early dementia (PrAISED) - A Protocol
Rupinder K. Bajwa, Sarah E. Goldberg, Veronika Van der Wardt, Clare Burgon, Claudio Di Lorito, Maureen Godfrey, Marianne Dunlop, Pip Logan, Tahir Masud, John Gladman, Helen Smith, Vicky Hood-Moore, Vicky Booth, Roshan Das Nair, Kristian Pollock, Kavita Vedhara, Rhiannon Tudor Edwards, Carys Jones, Zoe Hoare, Andrew Brand, Rowan H. Harwood
Comparison of 22G standard and Franseen needles in endoscopic ultrasound-guided fine-needle aspiration for diagnosing pancreatic mass lesions: Study protocol for a controlled trial
Masahiro Itonaga, Satoru Yasukawa, Toshio Shimokawa, Mamoru Takenaka, Nobuyasu Fukutake, Takeshi Ogura, Junichi Sakagami, Hideyuki Shiomi, Yasushi Okura, Osamu Inatomi, Hisakazu Matsumoto, Akira Kurita, Azumi Suzuki, Kiyohito Tanaka, Masayuki Kitano
Treatment of hospital-acquired pneumonia with multi-drug resistant organism by Buzhong Yiqi decoction based on Fuzheng Quxie classical prescription: study protocol for a randomized controlled trial
Dong Deng, Zhenyi Chen, Liyang Jia, Jianhong Bu, Miaoqing Ye, Lihua Sun, Yun Gen, Wen Zhang, Gang Chen, Bangjiang Fang