Ausgabe 1/2022
Inhalt (1067 Artikel)
Efficacy of Chinese herbal medicine Jiangniaosuan formula for treatment of hyperuricemia: study protocol for a double-blinded non-inferiority randomized controlled clinical trial
Yafang Guo, Hong Lu, Jing Gan, Dongdong Li, Jiandong Gao, Changming Zhang
Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan—a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial)
Ameer Muhammad, Zoha Zahid Fazal, Benazir Baloch, Imran Nisar, Fyezah Jehan, Yasir Shafiq
Does serum progesterone level impact the ongoing pregnancy rate in frozen embryo transfer under artificial preparation with vaginal progesterone? Study protocol for a randomized controlled trial
Lin Haiyan, Yang Gang, Li Yu, Li Lin, Chen Xiaoli, Zhang Qingxue
Low-dose corticosteroid therapy for cardiogenic shock in adults (COCCA): study protocol for a randomized controlled trial
Armand Mekontso Dessap, François Bagate, Clément Delmas, Tristan Morichau-Beauchant, Bernard Cholley, Alain Cariou, Benoit Lattuca, Mouhamed Moussa, Nicolas Mongardon, Damien Fard, Matthieu Schmidt, Adrien Bouglé, Mathieu Kerneis, Emmanuel Vivier, François Roubille, Matthieu Duprey, Véronique Decalf, Thibaud Genet, Messaouda Merzoug, Etienne Audureau, Pierre Squara
Impact of telelactation services on breastfeeding outcomes among Black and Latinx parents: protocol for the Tele-MILC randomized controlled trial
Lori Uscher-Pines, Jill Demirci, Molly Waymouth, Rebecca Lawrence, Amanda Parks, Ateev Mehrotra, Kristin Ray, Maria DeYoreo, Kandice Kapinos
Effect of low-load resistance training with different degrees of blood flow restriction in patients with knee osteoarthritis: study protocol for a randomized trial
Hao-Nan Wang, Yan Chen, Lin Cheng, Shen-Tao Wang, De-Xin Hu, Li-Na Wang, Guo-Xin Ni
Social Mobile Approaches to Reducing Weight (SMART) 2.0: protocol of a randomized controlled trial among young adults in university settings
Shadia J. Mansour-Assi, Natalie M. Golaszewski, Victoria Lawhun Costello, David Wing, Hailey Persinger, Aaron Coleman, Leslie Lytle, Britta A. Larsen, Sonia Jain, Nadir Weibel, Cheryl L. Rock, Kevin Patrick, Eric Hekler, Job G. Godino
Effect of different conditioning methods of traditional Chinese health exercise on lung function in healthy middle-aged and elderly people: study protocol for a randomized controlled trial
Wenlong Li, Yapei Song, Qiuping Xiang, Xinlei Wang, Xiaoyun Wei, Tonggang Fan
Acupuncture for prostatectomy incontinence: study protocol for a multicenter single-blind randomized parallel controlled trial
Yao Zhang, Shanqi Guo, Chaoran Wang, Xiaodi Liu, Yan Liu, Hongcai Shang, Peiying Yang, Liang Wang, Jingbo Zhai, Xiaojiang Li, Yingjie Jia
Efficacy and safety of Xiaoyao pills for mild to moderate depression: study protocol for a randomized controlled trial
Zhe Xue, Zhen Huang, Shu-li Cheng, Xi-hong Wang, Xuan Zhou, Qing-yu Ma, Jia-xu Chen
Efficacy of acupuncture and its influence on the emotional network in adult insomnia patients: protocol for a randomized controlled clinical trial
Tongfei Jiang, Qi Zhang, Fang Yuan, Fan Zhang, Jing Guo
Testing the efficacy of a couple-focused, tailored eHealth intervention for symptom self-management among men with prostate cancer and their partners: the study protocol
Lixin Song, Matthew E. Nielsen, Ronald C. Chen, Christine Rini, Thomas C. Keyserling, Eno Idiagbonya, Gail P. Fuller, Laurel Northouse, Mary H. Palmer, Xianming Tan
Statistical analysis plan for the Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian, fallopian tube or primary peritoneal cancer (of clear cell, endometrioid and high-grade serous type, and carcinosarcoma) trial (DICE)
Consuelo Nóhpal de la Rosa, Jonathan Krell, Emily Day, Aaron Clarke, Meena Reddi, Lee Webber, Francesca Fiorentino
Nurse-led self-management support after organ transplantation—protocol of a multicentre, stepped-wedge randomized controlled trial
Regina van Zanten, Monique van Dijk, Joost van Rosmalen, Denise Beck, Robert Zietse, Ann Van Hecke, AnneLoes van Staa, Emma K. Massey, Denise Beck, Monique van Dijk, Marleen Goedendorp, Martijn van den Hoogen, Erwin Ista, Louise Maasdam, Olivier Manintveld, Emma K. Massey, Joost van Rosmalen, Annelies de Weerd, Regina van Zanten, Robert Zietse, Janet Been-Dahmen, AnneLoes van Staa, Ann Van Hecke, Jeannet Bisschop, Paul van der Boog, Maaike Konijn, Marjo van Helden, Luuk Hilbrands, Coby Annema, Lyda Engelsman, Tally Norder, Christina Oosterhoff, Irma Saro, Geesje Smeenge, Sanne Bosman, Arjan van Zuilen, Marleen van Buren, Marcia Kho, Marlies Reinders, Ruth Dam, Tessa van Diemen, Esther Nijgh, Esther de Haan, Anja Kooistra
The effect of low-intensity whole-body vibration with or without high-intensity resistance and impact training on risk factors for proximal femur fragility fracture in postmenopausal women with low bone mass: study protocol for the VIBMOR randomized controlled trial
Belinda Beck, Clinton Rubin, Amy Harding, Sanjoy Paul, Mark Forwood
Guided meditation for vision acuity training on adolescent myopia: study protocol for an open-label, prospective, multicenter, randomized controlled trial
Yibo Li, Lili Zhu, Raoying Wang, Xingyue Yang, Xinqi Jiang, Tao Lu
Using mHealth to promote parents’ brushing of preschool children’s teeth: a protocol for a randomized factorial trial using the Multi-phase Optimization Strategy (MOST)
Merna Ihab, Wafaa Essam El Din, Nour Ammar, Randa Yassin, Maha El Tantawi
Fasting before living-kidney donation: effect on donor well-being and postoperative recovery: study protocol of a multicenter randomized controlled trial
C. A. J. Oudmaijer, R. C. Minnee, R. A. Pol, W. M. C. van den Boogaard, D. S. J. Komninos, J. van de Wetering, M. H. van Heugten, E. J. Hoorn, J. S. F. Sanders, J. H. J. Hoeijmakers, W. P. Vermeij, J. N. M. IJzermans
Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol
Francisco Mera-Cordero, Sara Bonet-Monne, Jesús Almeda-Ortega, Ana García-Sangenís, Oriol Cunillera-Puèrtolas, Sara Contreras-Martos, Gemma Alvarez-Muñoz, Ramon Monfà, Marina Balanzo-Joué, Rosa Morros, Betlem Salvador-Gonzalez
Effectiveness of lumbar stabilization exercise with real-time ultrasound imaging biofeedback on lumbar multifidus muscle cross-sectional area in individuals with non-specific chronic low back pain: a study protocol for a randomized controlled trial
Raheem Sarafadeen, Sokunbi O. Ganiyu, Aminu A. Ibrahim, Anas Ismail, Mukadas O. Akindele, Bashir Kaka, Adedapo W. Awotidebe
DUbbing Language-therapy CINEma-based in Aphasia post-Stroke (DULCINEA): study protocol for a randomized crossover pilot trial
Blanca Fuentes, Lydia de la Fuente-Gómez, Cristian Sempere-Iborra, Celia Delgado-Fernández, Aida Tarifa-Rodríguez, María Alonso de Leciñana, Elena de Celis-Ruiz, Raquel Gutiérrez-Zúñiga, José López-Tàppero, Marta Martín Alonso, Sylvia Pastor-Yborra, Ricardo Rigual, Gerardo Ruiz-Ares, Jorge Rodríguez-Pardo, Javier Virués-Ortega, Alberto M. Borobia, Paloma Blanco, Nereida Bueno-Guerra
ABBaH teens: Activity Breaks for Brain Health in adolescents: study protocol for a randomized crossover trial
Emerald G. Heiland, Karin Kjellenberg, Olga Tarassova, Maria Fernström, Gisela Nyberg, Maria M. Ekblom, Björg Helgadottir, Örjan Ekblom
The effect of obstructive jaundice on the sensitivity of intravenous anesthetic of remimazolam: study protocol for a controlled multicenter trial
Wen Liu, Bin Yang, Jun-Wei Ji, Hua Yang, Hong-Hao Song, Hai-Bo Qiu, Jin-Chao Song
Genicular artery embolization as a novel treatment for mild to moderate knee osteoarthritis: protocol design of a randomized sham-controlled clinical trial
T. A. van Zadelhoff, A. Moelker, S. M. A. Bierma-Zeinstra, P. K. Bos, G. P. Krestin, E. H. G. Oei
Sharing research results with Latina breast cancer survivors who participated in a community-engaged behavioral RCT study: a descriptive cross-sectional survey study
Jackie Bonilla, Alia Alhomsi, Jasmine Santoyo-Olsson, Anita L. Stewart, Carmen Ortiz, Cathy Samayoa, Alma Torres-Nguyen, Helen Palomino, La Verne Coleman, Aday Urias, Nayeli Gonzalez, Silvia Araceli Cervantes, Ysabel Duron, Anna María Nápoles
PATHWEIGH, pragmatic weight management in adult patients in primary care in Colorado, USA: study protocol for a stepped wedge cluster randomized trial
Krithika Suresh, Jodi Summers Holtrop, L. Miriam Dickinson, Emileigh Willems, Peter C. Smith, R. Mark Gritz, Leigh Perreault
Multiple secondary outcome analyses: precise interpretation is important
Richard A. Parker, Christopher J. Weir
Nasal high-flow compared to non-invasive ventilation in treatment of acute acidotic hypercapnic exacerbation of chronic obstructive pulmonary disease—protocol for a randomized controlled noninferiority trial (ELVIS)
Jens Bräunlich, Nicole Köppe-Bauernfeind, David Petroff, Annegret Franke, Hubert Wirtz
Comparison of outcomes and side effects for neoadjuvant chemotherapy with weekly cisplatin and paclitaxel followed by chemoradiation vs. chemoradiation alone in stage IIB–IVA cervical cancer: study protocol for a randomized controlled trial
Jing Li, Hua Liu, Ya Li, Jian Li, Lifei Shen, Wenqing Long, Chenmin Yang, Haoping Xu, Wenqi Xi, Rong Cai, Weiwei Feng
Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)—protocol for a randomized clinical trial
L. Morales-Quinteros, M. J. Schultz, A. Serpa-Neto, M. Antonelli, D. L. Grieco, O. Roca, N. P. Juffermans, C. de Haro, D. de Mendoza, Ll. Blanch, M. Camprubí-Rimblas, Gemma Gomà, A. Artigas-Raventós
The SMARTscreen Trial: a randomised controlled trial investigating the efficacy of a GP-endorsed narrative SMS to increase participation in the Australian National Bowel Cancer Screening Program
Anna Wood, Jon D. Emery, Mark Jenkins, Patty Chondros, Tina Campbell, Edweana Wenkart, Clare O’Reilly, Tony Cowie, Ian Dixon, Julie Toner, Hourieh Khalajzadeh, Javiera Martinez Gutierrez, Linda Govan, Gemma Buckle, Jennifer G. McIntosh
Effects of acceptance and commitment therapy on self-management skills and psychological resilience of young and middle-aged patients underwent percutaneous transluminal coronary intervention for primary myocardial infarction: a pilot study
Jiaoyu Cao, Panpan Sun, Lixiang Zhang, Xia Chen, Wenjuan Gui, Anping Ou, Kaibing Chen, Likun Ma
Efficacy of repetitive transcranial magnetic stimulation (rTMS) for reducing consumption in patients with alcohol use disorders (ALCOSTIM): study protocol for a randomized controlled trial
Benjamin Petit, Agnès Soudry-Faure, Ludovic Jeanjean, Jack Foucher, Laurence Lalanne, Maud Carpentier, Lysiane Jonval, Coralie Allard, Mathilde Ravier, Amine Ben Mohamed, Vincent Meille, Benoit Trojak
Correction to: Working to increase stability through exercise (WISE): screening, recruitment, and baseline characteristics
Christopher N. Sciamanna, Noel H. Ballentine, Melissa Bopp, Vernon M. Chinchilli, Joseph T. Ciccolo, Gabrielle Delauter, Abigail Fisher, Edward J. Fox, Suzanne M. Jan De Beur, Kalen Kearcher, Jennifer L. Kraschnewski, Erik Lehman, Kathleen M. McTigue, Edward McAuley, Anuradha Paranjape, Sol Rodriguez-Colon, Liza S. Rovniak, Kayla Rutt, Joshua M. Smyth, Kerry J. Stewart, Heather L. Stuckey, Annie Tsay
Effect of dexamethasone in patients with ARDS and COVID-19 (REMED trial)—study protocol for a prospective, multi-centre, open-label, parallel-group, randomized controlled trial
Jan Maláska, Jan Stašek, František Duška, Martin Balík, Jan Máca, Jan Hruda, Tomáš Vymazal, Olga Klementová, Jan Zatloukal, Tomáš Gabrhelík, Pavel Novotný, Regina Demlová, Jana Kubátová, Jana Vinklerová, Adam Svobodník, Milan Kratochvíl, Jozef Klučka, Roman Gál, Mervyn Singer
Design and rationale for a comparison study of Olmesartan and Valsartan On myocardial metabolism In patients with Dilated cardiomyopathy (OVOID) trial: study protocol for a randomized controlled trial
Sua Jo, Hyeyeon Moon, Kyungil Park, Chang-Bae Sohn, Jeonghwan Kim, Yong-Seop Kwon, Su Hong Kim
Effects of Bushen-Jiangya granules on blood pressure and pharmacogenomic evaluation in low-to-medium-risk hypertensive patients: study protocol for a randomized double-blind controlled trial
Xiaochen Yang, Lanping Liu, Xingjiang Xiong, Yun Zhang, Yongmei Liu, Hongzheng Li, Kuiwu Yao, Jie Wang
Association between blood glucose levels and Glasgow Outcome Score in patients with traumatic brain injury: secondary analysis of a randomized trial
Tao Yuan, Hongyu He, Yuepeng Liu, Jianwei Wang, Xin Kang, Guanghui Fu, Fangfang Xie, Aimin Li, Jun Chen, Wenxue Wang
Pneumococcal conjugate vaccination schedules in infants—acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study
Grant A. Mackenzie, Isaac Osei, Rasheed Salaudeen, Ousman Secka, Umberto D’Alessandro, Ed Clarke, Jonas Schmidt-Chanasit, Paul V. Licciardi, Cattram Nguyen, Brian Greenwood, Kim Mulholland
Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial
Siobhan Wong, Leanne Hassett, Harriet Koorts, Anne Grunseit, Allison Tong, Anne Tiedemann, Colin J. Greaves, Abby Haynes, Andrew Milat, Lisa A. Harvey, Nicholas F. Taylor, Rana S. Hinman, Marina De Barros Pinherio, Matthew Jennings, Daniel Treacy, Sandra O’Rourke, Courtney West, Elizabeth Ramsay, Catherine Kirkham, Claire Morris, Catherine Sherrington
Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial
Roger Andrey Carvalho Jardim, Tamara Silva de Sousa, Wueyla Nicoly Nascimento dos Santos, Areolino Pena Matos, Natália Camargo Rodrigues Iosimuta
Outcome selection for tissue-agnostic drug trials for immune-mediated inflammatory diseases: a systematic review of core outcome sets and regulatory guidance
Olalekan Lee Aiyegbusi, Lavinia Ferrante di Ruffano, Ameeta Retzer, Philip N. Newsome, Christopher D. Buckley, Melanie J. Calvert
Measuring implementation fidelity in a cluster-randomized pragmatic trial: development and use of a quantitative multi-component approach
Miranda B. Olson, Ellen M. McCreedy, Rosa R. Baier, Renée R. Shield, Esme E. Zediker, Rebecca Uth, Kali S. Thomas, Vincent Mor, Roee Gutman, James L. Rudolph
Effects of the addition of transcutaneous electrical stimulation to non-pharmacological measures in labor pain: study protocol for a randomized controlled trial
Naiara Toledo Dias, Patrícia Roberta Santos, Thais Alves Cândido, Rogério de Melo Costa Pinto, Ana Paula Magalhães Resende, Vanessa Santos Pereira-Baldon
Nicotinamide riboside as a neuroprotective therapy for glaucoma: study protocol for a randomized, double-blind, placebo-control trial
Christopher Kai Shun Leung, Seraph Tianmin Ren, Poemen Pui Man Chan, Kelvin Ho Nam Wan, Aziz Ka Wai Kam, Gilda Wing Ki Lai, Vivian Sheung Man Chiu, Match Wai Lun Ko, Cedric Ka Fai Yiu, Marco Chak Yan Yu
Effectiveness of a high-intensive trauma-focused, family-based therapy for youth exposed to family violence: study protocol for a randomized controlled trial
Valerie Fictorie, Caroline Jonkman, Margreet Visser, Marjolein Vandenbosch, Majone Steketee, Carlo Schuengel
Decision support system to evaluate ventilation in the acute respiratory distress syndrome (DeVENT study)—trial protocol
Brijesh Patel, Sharon Mumby, Nicholas Johnson, Emanuela Falaschetti, Jorgen Hansen, Ian Adcock, Danny McAuley, Masao Takata, Dan S. Karbing, Matthieu Jabaudon, Peter Schellengowski, Stephen E. Rees
Correction to: The CombinADO study to assess the impact of a combination intervention strategy on viral suppression, antiretroviral therapy adherence, and retention in HIV care among adolescents and young people living with HIV: protocol for a cluster-randomized controlled trial
Phepo Mogoba, Maia Lesosky, Allison Zerbe, Joana Falcao, Claude Ann Mellins, Christopher Desmond, Carlos Arnaldo, Bill Kapogiannis, Landon Myer, Elaine J. Abrams
Effectiveness of referral to a population-level telephone coaching service for improving health risk behaviours in people with a mental health condition: study protocol for a randomised controlled trial
Grace Hanly, Elizabeth Campbell, Kate Bartlem, Julia Dray, Caitlin Fehily, Tegan Bradley, Sonya Murray, Christophe Lecathelinais, John Wiggers, Luke Wolfenden, Kate Reid, Tahlia Reynolds, Jenny Bowman
An enhanced participant information leaflet and multimedia intervention to improve the quality of informed consent to a randomised clinical trial enrolling people living with HIV and obesity: a protocol for a Study Within A Trial (SWAT)
Lydia O’Sullivan, Stefano Savinelli, Stephen O’Hare, Sinéad Holden, Ciara McHugh, Patrick Mallon, Peter Doran
Statistical analysis plan for Better Evidence for Selecting Transplant Fluids (BEST-Fluids): a randomised controlled trial of the effect of intravenous fluid therapy with balanced crystalloid versus saline on the incidence of delayed graft function in deceased donor kidney transplantation
Elaine M. Pascoe, Steven J. Chadban, Magid A. Fahim, Carmel M. Hawley, David W. Johnson, Michael G. Collins
10.6-μm infrared laser as adjuvant therapy for diabetic peripheral neuropathy: study protocol for a double-blind, randomized controlled trial
Lin Lin, Yi Chen, Yuxia Li, Ke Cheng, Haiping Deng, Jianping Lu, Ling Zhao, Xueyong Shen
Achieving Quality and Effectiveness in Dementia Using Crisis Teams (AQUEDUCT): a study protocol for a randomised controlled trial of a Resource Kit
Donna Maria Coleston-Shields, David Challis, Angela Worden, Emma Broome, Tom Dening, Boliang Guo, Juanita Hoe, Brynmor Lloyd-Evans, Esme Moniz-Cook, Steve Morris, Fiona Poland, David Prothero, Martin Orrell
Laparoscopically guided transversus abdominis plane block versus local wound analgesia in laparoscopic surgery for peritoneal endometriosis: study protocol for a prospective randomized controlled double-blinded LTAP-trial
Anna Terho, Terhi Puhto, Johanna Laru, Outi Uimari, Pasi Ohtonen, Tero Rautio, Sari Koivurova
Tranexamic acid to prevent operation in chronic subdural haematoma (TORCH): study protocol for a randomised placebo-controlled clinical trial
S. Immenga, R. Lodewijkx, Y. B. W. E. M. Roos, S. Middeldorp, C. B. L. M. Majoie, H. C. Willems, W. P. Vandertop, D. Verbaan
Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy—the MecMeth/NOA-24 trial
Thomas Zeyen, Anna-Laura Potthoff, Robert Nemeth, Dieter H. Heiland, Michael C. Burger, Joachim P. Steinbach, Peter Hau, Ghazaleh Tabatabai, Martin Glas, Uwe Schlegel, Oliver Grauer, Dietmar Krex, Oliver Schnell, Roland Goldbrunner, Michael Sabel, Niklas Thon, Daniel Delev, Hans Clusmann, Clemens Seidel, Erdem Güresir, Matthias Schmid, Patrick Schuss, Frank A. Giordano, Alexander Radbruch, Albert Becker, Johannes Weller, Christina Schaub, Hartmut Vatter, Judith Schilling, Frank Winkler, Ulrich Herrlinger, Matthias Schneider
Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial
Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Iqra Farooq, Rutaba Akmal, Muhammad Ahmad Imran, Larab Kalsoom, Sidra Ashraf, Sundas Rafique, Muhammad Ghufran, Muhammad Kiwan Akram, Sohaib-ur-Rehman, Muhammad Faisal Nadeem, Nazish Matti, Uzma Nasim Siddiqui, Ayesha Humayun, Qazi Abdul Saboor, Ali Ahmad, Muhammad Ashraf, Mateen Izhar, Zaigham Habib, Kanwal Hayat, Ghazala Amjad, Misbah Kousar, Shahroze Arshad, Umair Hafeez, Tayyab Mughal, Muhammad Sikandar Saleem, Ammara Ahmad, Abeer bin Awais, Noman Khalid, Qurat-ul-Ain Iqbal, Muhammad Hassan, Abdul Rehman Virk, Mehak Gul, Muhammad Tayyab Naeem, Roa Umer, Musa Khalil, Tayyaba Muzafar, Sibgha Zulfiqar, Saadia Shahzad Alam, Emed Chohan, Muhammad Imran Anwar, Ali Rafique Mirza, Amber Malik, Talha Mahmud, Adeen Akmal, Syed Sami Husain Sherazi, Zartasha Safdar, Sohail Ahmad, Ali Arshad, Khawar Nawaz, Muhammad Ismail Khalid Yousaf, Muhammad Nauman Zahid
Telemedicine-delivered cognitive-behavioral therapy for insomnia in alcohol use disorder (AUD): study protocol for a randomized controlled trial
J. Todd Arnedt, M. Elizabeth Cardoni, Deirdre A. Conroy, Mandilyn Graham, Sajni Amin, Kipling M. Bohnert, Andrew D. Krystal, Mark A. Ilgen
Primary care disease management for venous leg ulceration—study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126)
Jonas D. Senft, Thomas Fleischhauer, Jona Frasch, Wiebke van Rees, Manuel Feißt, Simon Schwill, Christine Fink, Regina Poß-Doering, Michel Wensing, Uwe Müller-Bühl, Joachim Szecsenyi
Effectiveness of the Shenzhuo formula in the treatment of patients with macroalbuminuria secondary to diabetic kidney disease: protocol update and statistical analysis plan
Yu Wei, Yi-Shan Huang, Ze Yang, Xinmiao Wang, Yanbo Li, Ying Zhang, Lin-Hua Zhao, Xiaolin Tong
Development and evaluation of rapid data-enabled access to routine clinical information to enhance early recruitment to the national clinical platform trial of COVID-19 community treatments
Caroline Cake, Emma Ogburn, Heather Pinches, Garry Coleman, David Seymour, Fran Woodard, Sinduja Manohar, Marjia Monsur, Martin Landray, Gaynor Dalton, Andrew D. Morris, Patrick F. Chinnery, F. D. Richard Hobbs, Christopher Butler
Individualized positive end-expiratory pressure guided by end-expiratory lung volume in early acute respiratory distress syndrome: study protocol for the multicenter, randomized IPERPEEP trial
Domenico Luca Grieco, Salvatore Maurizio Maggiore, Giacomo Bellani, Savino Spadaro, Elena Spinelli, Tommaso Tonetti, Luca S. Menga, Marco Pozzi, Denise Battaglini, Rosa Di Mussi, Andrea Bruni, Andrea De Gaetano, Carmine Giovanni Iovino, Matteo Brioni, Francesco Mojoli, Giuseppe Foti, Carlo Aberto Volta, Paolo Pelosi, Paolo Navalesi, Salvatore Grasso, V. Marco Ranieri, Massimo Antonelli
The FEED1 trial: protocol for a randomised controlled trial of full milk feeds versus intravenous fluids with gradual feeding for preterm infants (30–33 weeks gestational age)
Eleanor J. Mitchell, Garry Meakin, Josie Anderson, Jon Dorling, Chris Gale, Rachel Haines, Charlotte Kenyan, Mark J. Johnson, William McGuire, Hema Mistry, Alan Montgomery, Sam Oddie, Reuben Ogollah, Phoebe Pallotti, Christopher Partlett, Kate F. Walker, Shalini Ojha
Comparison of Buyang Huanwu granules and Naoxintong capsules in the treatment of stable angina pectoris: rationale and design of a randomized, blinded, multicentre clinical trial
Yu Wang, Yuhan Xu, Ling Zhang, Shuwei Huang, Liping Dou, Jiehong Yang, Wei Fu, Peng Zhou, Haitong Wan
Effect of perioperative cognitive behavioural therapy on chronic post-surgical pain among breast cancer patients with high pain catastrophising characteristics: protocol for a double-blinded randomised controlled trial
Aneurin Moorthy, Damien Lowry, Carla Edgley, Maire-Brid Casey, Donal Buggy
Postbariatric EArly discharge Controlled by Healthdot (PEACH) trial: study protocol for a preference-based randomized trial
Jai Scheerhoorn, Lisa van Ede, Misha D. P. Luyer, Marc P. Buise, R. Arthur Bouwman, Simon W. Nienhuijs
Effects of traditional Chinese medicine collaborative model (TCMCM) combined with adjuvant chemotherapy on IIIb and IIIc gastric cancer: a protocol for a randomized controlled trial
Zhaoyan Li, Guangtao Zhang, Nida Cao, Jingjuan Xu, Jiahuan Dong, Jia Li, Xiaohong Zhu, Yan Xu, Chen Han, Rui Wang, Xiang Xia, Gang Zhao, Xiangkun Huan, Jin Fan, Aiguang Zhao
Effect of dynamic neuromuscular stabilization on balance and trunk function in people with multiple sclerosis: protocol for a randomized control trial
Laleh Abadi Marand, Shohreh Noorizadeh Dehkordi, Mahtab Roohi-Azizi, Mehdi Dadgoo
Robotic- and orthosensor-assisted versus manual (ROAM) total knee replacement: a study protocol for a randomised controlled trial
Nick D. Clement, Michelle Bardgett, Steven Galloway, Y. Jenny Baron, Karen Smith, David J. Weir, David J. Deehan
A cluster-randomised, non-inferiority trial of the impact of a two-dose compared to three-dose schedule of pneumococcal conjugate vaccination in rural Gambia: the PVS trial
Grant A. Mackenzie, Isaac Osei, Rasheed Salaudeen, Ilias Hossain, Benjamin Young, Ousman Secka, Umberto D’Alessandro, Arto A. Palmu, Jukka Jokinen, Jason Hinds, Stefan Flasche, Kim Mulholland, Cattram Nguyen, Brian Greenwood
A randomized double-blind cross-over trial to study the effects of resistant starch prebiotic in chronic kidney disease (ReSPECKD)
Maryam Shamloo, Rebecca Mollard, Haizhou Wang, Kulwant Kingra, Navdeep Tangri, Dylan MacKay
The FACAM study: protocol for a randomized controlled study of an early interdisciplinary intervention to support women in vulnerable positions through pregnancy and the first 5 years of motherhood
Maiken Pontoppidan, Lene Nygaard, Mette Thorsager, Mette Friis-Hansen, Deborah Davis, Ellen Aagaard Nohr
Intraoperative endoluminal pyloromyotomy for reduction of delayed gastric emptying after pylorus preserving partial pancreaticoduodenectomy (PORRIDGE trial): study protocol for a randomised controlled trial
Matthias C. Schrempf, David R. M. Pinto, Sebastian Wolf, Bernd Geissler, Florian Sommer, Michael Hoffmann, Dmytro Vlasenko, Johanna Gutschon, Matthias Anthuber
Pediatric Tuina in children with autism spectrum disorder: a study protocol for a randomized controlled trial
Xiang Feng, Quanrui Jiang, Yuxing Zhang, Tao Li, Wei Wei, Jun Yu, Wu Li, Jiangshan Li
The Unplugged program in Chile (“Yo Sé Lo Que Quiero”) for substance use prevention among early adolescents: study protocol for a randomized controlled trial
Jorge Gaete, Saray Ramírez, Sofía Gana, Daniela Valenzuela, Ricardo Araya
Correction to: Hearing dogs for people with severe and profound hearing loss: a wait-list design randomised controlled trial investigating their effectiveness and cost-effectiveness
Lucy Stuttard, Philip Boyle, Caroline Fairhurst, Catherine Hewitt, Francesco Longo, Simon Walker, Helen Weatherly, Emese Mayhew, Bryony Beresford
Vitamin D3 and calcium carbonate supplementation for adolescents with HIV to reduce musculoskeletal morbidity and immunopathology (VITALITY trial): study protocol for a randomised placebo-controlled trial
Nyasha Veronica Dzavakwa, Molly Chisenga, Grace McHugh, Suzanne Filteau, Celia Louise Gregson, Lackson Kasonka, Katharina Kranzer, Hildah Banda Mabuda, Hilda Mujuru, Nicol Redzo, Sarah Rowland-Jones, Ulrich E. Schaible, Victoria Simms, Rashida Abbas Ferrand
Effectiveness of psychosocial school interventions in Finnish schools for refugee and immigrant children, “Refugees Well School” in Finland (RWS-FI): a protocol for a cluster randomized controlled trial
Reeta Kankaanpää, Sanni Aalto, Mervi Vänskä, Riina Lepistö, Raija-Leena Punamäki, Emma Soye, Charles Watters, Arnfinn Andersen, Per Kristian Hilden, Ilse Derluyn, An Verelst, Kirsi Peltonen
Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes
Athena Philis-Tsimikas, Addie L. Fortmann, Job G. Godino, James Schultz, Scott C. Roesch, Todd P. Gilmer, Emilia Farcas, Haley Sandoval, Kimberly L. Savin, Taylor Clark, Mariya Chichmarenko, Jennifer A. Jones, Linda C. Gallo
Activities supporting the growth of Clinical Trial Networks in Australia
Fiona Nemeh, Rachelle Buchbinder, Carmel M. Hawley, Mark R. Nelson, Jacqui G. Waterkeyn, Christopher M. Reid
Are realist randomised controlled trials possible? A reflection on the INCLUSIVE evaluation of a whole-school, bullying-prevention intervention
Emily A. Warren, G. J. Melendez-Torres, Chris Bonell
Third-generation cognitive behavioral therapy versus treatment-as-usual for attention deficit and hyperactivity disorder: a multicenter randomized controlled trial
Laetitia Crouzet, Anne Gramond, Carey Suehs, Pascale Fabbro-Peray, Mocrane Abbar, Jorge Lopez-Castroman
The ALLEGRO trial: a placebo controlled randomised trial of intravenous lidocaine in accelerating gastrointestinal recovery after colorectal surgery
Hugh M. Paterson, Seonaidh Cotton, John Norrie, Susan Nimmo, Irwin Foo, Angie Balfour, Doug Speake, Graeme MacLennan, Andrew Stoddart, Karen Innes, Sarah Cameron, Lorna Aucott, Kirsty McCormack
Efficacy of acupuncture on cognitive function in poststroke depression: study protocol for a randomized, placebo-controlled trial
Ling Chen, Yi Chen, Lihua Wu, Wen Fu, Luanmian Wu, Wenbin Fu
Acupuncture combined with traditional Chinese medicine e-aid cognitive behavioral therapy for insomnia (TCM-eCBT-I) for chronic insomnia: study protocol for a randomized controlled trial
Cheng-yong Liu, Ya-nan Zhao, Xiao-qiu Wang, Shan Qin, Qing-yun Wan, Shi-yu Zheng, Wen-zhong Wu
Brain activity and upper limb movement analysis in children with Down syndrome undergoing transcranial direct current stimulation combined with virtual reality training: study protocol for a randomized controlled trial
Jamile Benite Palma Lopes, Isabela Marques Miziara, Danial Kahani, Rodolfo Borges Parreira, Natalia de Almeida Carvalho Duarte, Roberta Delasta Lazzari, Lucas Villalta Santos, Carlos Bandeira de Mello Monteiro, Deborah Carvalho da Silva Cardoso, Juliana de Oliveira Hassel Mendes, Vera Lucia dos Santos Alves, Iransé Oliveira Silva, Luis Vicente Oliveira, Bernard Arthur Conway, Manuela Galli, Veronica Cimolin, Claudia Santos Oliveira
Blood flow Restriction training After patellar INStability (BRAINS Trial)
Benjamin D. Brightwell, Austin Stone, Xiaojuan Li, Peter Hardy, Katherine Thompson, Brian Noehren, Cale Jacobs
Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a 3 arms community-based individually randomised controlled trial in decentralised Niger
Maguy Daures, Jérémie Hien, Kevin Phelan, Harouna Boubacar, Sanoussi Atté, Mahamadou Aboubacar, Ahmad A. G. M. Aly, Baweye Mayoum, Jean-Claude Azani, Jean-Jacques Koffi, Benjamin Séri, Aurélie Beuscart, Delphine Gabillard, Victoire Hubert, Cécile Cazes, Moumouni Kinda, Xavier Anglaret, Suvi Kangas, Susan Shepherd, Renaud Becquet
Impact of receiving recorded mental health recovery narratives on quality of life in people experiencing non-psychosis mental health problems (NEON-O Trial): updated randomised controlled trial protocol
Stefan Rennick-Egglestone, Rachel Elliott, Chris Newby, Clare Robinson, Mike Slade
Intertruncal versus classical approach to the ultrasound-guided supraclavicular brachial plexus block for upper extremity surgery: study protocol for a randomized non-inferiority trial
Quehua Luo, Yujing Cai, Hanbin Xie, Guoliang Sun, Jianqiang Guan, Yi Zhu, Weifeng Yao, Haihua Shu
Cluster randomised, controlled, triple-blind trial assessing the efficacy of intranasally administered virus-neutralising bovine colostrum supplement in preventing SARS-CoV-2 infection in household contacts of SARS-CoV-2-positive individuals: a study protocol
Anneli Uusküla, Aime Keis, Karolin Toompere, Anu Planken, Konstantin Rebrov
Study protocol for comparing Screening, Brief Intervention, and Referral to Treatment (SBIRT) to referral as usual for depression in African American churches
Sidney H. Hankerson, Rachel Shelton, Myrna Weissman, Kenneth B. Wells, Jeanne Teresi, Janhavi Mallaiah, Amita Joshua, Olajide Williams
Effect of acupuncture therapy combined with fluticasone propionate in the treatment of persistent allergic rhinitis: study protocol for a randomized controlled trial
Qi Fan, Yixuan Feng, Yan Hou, Feihu Wu, Wei Zhang, Wenbin Nie, Bin Li, Zhongyu Zhou, Wenbin Fu, Lei Shi, Zhongren Sun, Hong Zhao
Integrated Sustainable childhood Pneumonia and Infectious disease Reduction in Nigeria (INSPIRING) through whole system strengthening in Jigawa, Nigeria: study protocol for a cluster randomised controlled trial
Carina King, Rochelle Ann Burgess, Ayobami A. Bakare, Funmilayo Shittu, Julius Salako, Damola Bakare, Obioma C. Uchendu, Agnese Iuliano, Adamu Isah, Osebi Adams, Ibrahim Haruna, Abdullahi Magama, Tahlil Ahmed, Samy Ahmar, Christine Cassar, Paula Valentine, Temitayo Folorunso Olowookere, Matthew MacCalla, Hamish R. Graham, Eric D. McCollum, Adegoke G. Falade, Tim Colbourn, Carina King, Tim Colbourn, Rochelle Ann Burgess, Agnese Iuliano, Hamish R. Graham, Eric D. McCollum, Tahlil Ahmed, Samy Ahmar, Christine Cassar, Paula Valentine, Adamu Isah, Adams Osebi, Ibrahim Haruna, Abdullahi Magama, Ibrahim Seriki, Temitayo Folorunso Olowookere, Matt McCalla, Adegoke G. Falade, Ayobami Adebayo Bakare, Obioma Uchendu, Julius Salako, Funmilayo Shittu, Damola Bakare, Omotayo Olojede
Paediatric Acute Respiratory Distress Syndrome Neuromuscular Blockade study (PAN-study): a phase IV randomised controlled trial of early neuromuscular blockade in moderate-to-severe paediatric acute respiratory distress syndrome
Michelle W. Rudolph, Sjoerdtje Slager, Johannes G. M. Burgerhof, Job B.M. van Woensel, Jan-Willem C. Alffenaar, Roelie M. Wösten - van Asperen, Matthijs de Hoog, Marloes M. IJland, Martin C. J. Kneyber
DUDE - a universal prevention program for non-suicidal self-injurious behavior in adolescence based on effective emotion regulation: study protocol of a cluster-randomized controlled trial
Arne Buerger, Theresa Emser, Alexandra Seidel, Christin Scheiner, Cornelia von Schoenfeld, Viktoria Ruecker, Peter U. Heuschmann, Marcel Romanos
MOntelukast as a potential CHondroprotective treatment following Anterior cruciate ligament reconstruction (MOCHA Trial): study protocol for a double-blind, randomized, placebo-controlled clinical trial
Cale A. Jacobs, Caitlin E. W. Conley, Virginia Byers Kraus, Drew A. Lansdown, Brian C. Lau, Xiaojuan Li, Sharmila Majumdar, Kurt P. Spindler, Nicole G. Lemaster, Austin V. Stone
Vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative Age-Related macular degeneration (TIGER): study protocol for a phase 3, pan-European, two-group, non-commercial, active-control, observer-masked, superiority, randomised controlled surgical trial
Timothy L. Jackson, Catey Bunce, Riti Desai, Jost Hillenkamp, Chan Ning Lee, Noemi Lois, Tunde Peto, Barnaby C. Reeves, David H. Steel, Rhiannon T. Edwards, Jan C. van Meurs, Hatem Wafa, Yanzhong Wang
Effects of acupuncture treatment on postoperative gastrointestinal dysfunction in colorectal cancer: study protocol for randomized controlled trials
Xueyan Liu, Zhijie Wang, Hao Yao, Yanrong Yang, Huijuan Cao, Zhanhao Toh, Ruwen Zheng, Yi Ren
Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery
Maura Marcucci, Thomas W. Painter, David Conen, Kate Leslie, Vladimir V. Lomivorotov, Daniel Sessler, Matthew T. V. Chan, Flavia K. Borges, Maria J. Martínez Zapata, C. Y. Wang, Denis Xavier, Sandra N. Ofori, Giovanni Landoni, Sergey Efremov, Ydo V. Kleinlugtenbelt, Wojciech Szczeklik, Denis Schmartz, Amit X. Garg, Timothy G. Short, Maria Wittmann, Christian S. Meyhoff, Mohammed Amir, David Torres, Ameen Patel, Emmanuelle Duceppe, Kurtz Ruetzler, Joel L. Parlow, Vikas Tandon, Michael K. Wang, Edith Fleischmann, Carisi A. Polanczyk, Raja Jayaram, Sergey V. Astrakov, Mangala Rao, Tomas VanHelder, William K. K. Wu, Chao Chia Cheong, Sabry Ayad, Marat Abubakirov, Mikhail Kirov, Keyur Bhatt, Miriam de Nadal, Valery Likhvantsev, Pilar Paniagua Iglesisas, Hector J. Aguado, Michael McGillion, Andre Lamy, Richard P. Whitlock, Pavel Roshanov, David Stillo, Ingrid Copland, Jessica Vincent, Kumar Balasubramanian, Shrikant I. Bangdiwala, Bruce Biccard, Andrea Kurz, Sadeesh Srinathan, Shirley Petit, John Eikelboom, Toby Richards, Peter L. Gross, Pascal Alfonsi, Gordon Guyatt, Emily Belley-Cote, Jessica Spence, William McIntyre, Salim Yusuf, P. J. Devereaux
Protocol for ICiCLe-ALL-14 (InPOG-ALL-15-01): a prospective, risk stratified, randomised, multicentre, open label, controlled therapeutic trial for newly diagnosed childhood acute lymphoblastic leukaemia in India
Nandana Das, Shripad Banavali, Sameer Bakhshi, Amita Trehan, Venkatraman Radhakrishnan, Rachna Seth, Brijesh Arora, Gaurav Narula, Subir Sinha, Prakriti Roy, Manash Pratim Gogoi, Sayan Chatterjee, Bindhu Abraham, Parag Das, Vaskar Saha, Shekhar Krishnan
Efficacy and safety of traditional Chinese medicine in patients with acute exacerbation of idiopathic pulmonary fibrosis: study protocol for randomized, controlled, exploratory clinical trial
Zhang Hailong, Li Jiansheng, Guo Wen, Wang Lu, Zhang Dong, Zhao Limin, Zhou Miao, Luo Weixian
Efficacy and safety of Qushi Huayu granule for hyperlipidemia: study protocol for a randomized, double-blind, placebo-controlled trial
Yuanlong Sun, Na Hu, Gaofeng Chen, Yanjie Wang, Yiyang Hu, Maojun Ge, Yu Zhao
Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial
Yaseen Arabi, Sara Aldekhyl, Saad Al Qahtani, Hasan M. Al-Dorzi, Sheryl Ann Abdukahil, Jesna Jose, Mohammad Khulaif Al Harbi, Husain Al Haji, Mohammed Al Mutairi, Omar Al Zumai, Eman Al Qasim, Wedyan Al Wehaibi, Mohammed Alshahrani, Talal Albrahim, Ahmed Mady, Ali Al Bshabshe, Zohair Al Aseri, Zainab Al Duhailib, Ayman Kharaba, Rakan Alqahtani, Haifa Algethamy, Omar Alfaris, Omar Alnafel, Abdulrahman A. Al-Fares, Haytham Tlayjeh
Implementation of an in situ simulation-based training adapted from Morbidity and Mortality conference cases: effect on the occurrence of adverse events—study protocol of a cluster randomised controlled trial
Nicolas Michel, Bernard Bui-Xuan, Lionel Bapteste, Thomas Rimmele, Marc Lilot, François Chollet, Hélène Favre, Antoine Duclos, Philippe Michel
Effects of Tai Chi on the neuromuscular function of the patients with functional ankle instability: a study protocol for a randomized controlled trial
Huiru Tang, Min Mao, Daniel T. P. Fong, Qipeng Song, Yan Chen, Zhipeng Zhou, Cui Zhang, Jiangna Wang, Xuewen Tian, Wei Sun
Treatment of Impetigo with Antiseptics—Replacing Antibiotics (TIARA) trial: a single blind randomised controlled trial in school health clinics within socioeconomically disadvantaged communities in New Zealand
Sarah Primhak, Alicia Gataua, Diana Purvis, John M. D. Thompson, Cameron Walker, Emma Best, Alison Leversha
Embedding comprehensive smoking cessation programs into community clinics: study protocol for a cluster-randomized controlled trial
Wave-Ananda Baskerville, Theodore C. Friedman, Brian Hurley, Susan Hsieh, Tasha Dixon, Norma Mtume, Martin L. Lee, Luz Rodriguez, Briana Lopez, Lara A. Ray
Protocol for a cluster randomized control trial of the impact of the Breaking the Man Code workshops on adolescent boys’ intentions to seek help
Kylie King, Marisa Schlichthorst, Patty Chondros, Simon Rice, Anna Clark, Long Khanh-Dao Le, Cathrine Mihalopoulos, Jane Pirkis
Effect of Nigella sativa supplementation on kidney function, glycemic control, oxidative stress, inflammation, quality of life, and depression in diabetic hemodialysis patients: study protocol for a double-blind, randomized controlled trial
Alireza Rahmani, Vahid Maleki, Bahram Niknafs, Omid Mohammad Tavakoli-Rouzbehani, Ali Tarighat-Esfanjani
Effect of minocycline on the left ventricular function following ST-elevation myocardial infarction treated by primary percutaneous coronary intervention
Alireza Nasiri, Akbar Shafiee, Ali Hosseinsabet, Azita Hajhosein Talasaz, Arash Jalali, Mojtaba Salarifar
Paramedic Norwegian Acute Stroke Prehospital Project (ParaNASPP) study protocol: a stepped wedge randomised trial of stroke screening using the National Institutes of Health Stroke Scale in the ambulance
Helge Fagerheim Bugge, Mona Guterud, Kristi C. G. Bache, Anne-Cathrine Braarud, Erik Eriksen, Kjell Otto Fremstad, Hege Ihle-Hansen, Svein Håkon Ingebretsen, Jo Kramer-Johansen, Karianne Larsen, Jo Røislien, Kjetil Thorsen, Mathias Toft, Else Charlotte Sandset, Maren Ranhoff Hov
High-dose vitamin D substitution in patients with COVID-19: study protocol for a randomized, double-blind, placebo-controlled, multi-center study—VitCov Trial
Fabienne Jaun, Maria Boesing, Giorgia Lüthi-Corridori, Kristin Abig, Anja Makhdoomi, Nando Bloch, Christina Lins, Andrea Raess, Victoria Grillmayr, Philippe Haas, Philipp Schuetz, Luca Gabutti, Jürgen Muser, Anne B. Leuppi-Taegtmeyer, Stéphanie Giezendanner, Michael Brändle, Jörg D. Leuppi
Statistical analysis of publicly funded cluster randomised controlled trials: a review of the National Institute for Health Research Journals Library
Bright C. Offorha, Stephen J. Walters, Richard M. Jacques
Dental antibiotic stewardship: study protocol for developing international consensus on a core outcome set
Wendy Thompson, Leanne Teoh, Céline Pulcini, David Williams, Carole Pitkeathley, Vanessa Carter, Susie Sanderson, Glauco Torres, Tanya Walsh
PROPENSIX: pressure garment therapy using compressive dynamic Lycra® sleeve to improve bi-manual performance in unilateral cerebral palsy: a multicenter randomized controlled trial protocol
A. Gerard, M. Toussaint-Thorin, Y. Mohammad, G. Letellier, S. Fritot, S. Masson, A. Duhamel, C. Donskoff, Y. Zagame, L. Beghin, L. Gottrand
The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study
Diana R. Pereira, Eunice R. Silva, Carina Carvalho-Maia, Sara Monteiro-Reis, Catarina Lourenço, Rita Calisto, Ricardo João Teixeira, Linda E. Carlson, Genevieve Bart, Seppo J. Vainio, M. Goreti F. Sales, Carmen Jerónimo, Rui Henrique
Randomized phase III trial of intravenous and intraperitoneal paclitaxel with S-1 versus gemcitabine plus nab-paclitaxel for pancreatic ductal adenocarcinoma with peritoneal metastasis (SP study)
Tomohisa Yamamoto, Tsutomu Fujii, Satoshi Hirano, Fuyuhiko Motoi, Goro Honda, Kenichiro Uemura, Joji Kitayama, Michiaki Unno, Yasuhiro Kodera, Hiroki Yamaue, Toshio Shimokawa, Daisuke Hashimoto, So Yamaki, Hideyuki Yoshitomi, Fumihiko Miura, Hideki Ueno, Mitsugu Sekimoto, Sohei Satoi
PRACT: a pragmatic randomized adaptive clinical trial protocol to investigate a culturally adapted brief negotiational intervention for alcohol use in the emergency department in Tanzania
Catherine A. Staton, Siddhesh Zadey, Paige O’Leary, Ashley Phillips, Linda Minja, Monica H. Swahn, Jon Mark Hirshon, Judith Boshe, Francis Sakita, Joao Ricardo Nickenig Vissoci, Blandina T. Mmbaga
Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule
James A. Totterdell, Gladymar Perez Chacon, Marie J. Estcourt, Mark Jones, Peter Richmond, Thomas L. Snelling, Julie A. Marsh
The Best Services Trial (BeST?): a cluster randomised controlled trial comparing the clinical and cost-effectiveness of New Orleans Intervention Model with services as usual (SAU) for infants and young children entering care
Karen Crawford, Bridie Fitzpatick, Lynn McMahon, Matt Forde, Susanne Miller, Alex McConnachie, Martina Messow, Marion Henderson, Emma McIntosh, Kathleen Boyd, Dennis Ougrin, Phil Wilson, Nicholas Watson, Helen Minnis
Correction to: Statistical analysis plan for better evidence for selecting transplant fluids (BEST-fluids): a randomised controlled trial of the effect of intravenous fluid therapy with balanced crystalloid versus saline on the incidence of delayed graft function in deceased donor kidney transplantation
Elaine M. Pascoe, Steven J. Chadban, Magid A. Fahim, Carmel M. Hawley, David W. Johnson, Michael G. Collins
Efficacy of cognitive behavioral therapy on aggressive behavior in children with attention deficit hyperactivity disorder and emotion dysregulation: study protocol of a randomized controlled trial
C. Vacher, L. Romo, M. Dereure, M. Soler, M. C. Picot, D. Purper-Ouakil
The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial
Reshma Amin, Andrea Gershon, Francine Buchanan, Regina Pizzuti, Adam Qazi, Nishali Patel, Ruxandra Pinto, Myla E. Moretti, Munazzah Ambreen, Paula Abelha, Adele Baker, Sacha Bhatia, Cindy Brennan, Julia Bokhaut, Jackie Chiang, Nisha Cithiravel, Jana Collins, Daniel Cornejo Palma, Leah Costa, Katie N Dainty, Refika Ersu, Tom Fisher, Erin Fleischer, Sandy Fodey, Ian Fraser, Roger Goldstein, Janet Hyatt, Ashley Inman, Mary Irven, Joanna Janevsk, Raj Kohli, Sherri Lynne Katz, Wilma Koopman, Sarah Kuyntjes, David Leasa, Audrey Lim, Paty Sala Lopez, Denise Martins, Cathy Mawdsley, Sandra McKay, Doug McKim, Kristin McMillan, Ramsay McNay, Kevan Mehta, Riley Moss, Jodee Naylor, Mika Nonoyama, Michelle Overholt, April Price, Josee Roy, Madan Roy Christen Shoesmith, Aman Sidhu, Joanne Smith, Lisa Spooner, Aaron St-Laurent, Faiza Syed, Anu Tandon, Mark Thompson, Brenda Toonders, Tuyen Tran, Melissa Trinh, Robert Varadi, Shannon Venance, Kevin Workentin, Allison Zweerink, Louise Rose
Assessing the effect of an educational intervention on early childhood development among Mexican preschool children in the state of Oaxaca: a study protocol of a cluster randomized stepped-wedge trial
Amado D. Quezada-Sánchez, Evelyn Fuentes-Rivera, Angélica García-Martínez, María del Carmen Hernández-Chávez, Carlos Pineda-Antúnez, Martín Romero Martínez, Armando García-Guerra, Raquel García-Feregrino, Abby Madrigal-Ramírez, Tania Santiago-Angelino, Fabián Olvera-Flores, Lourdes Schnaas, Rafael Pérez-Escamilla, Edson Serván-Mori
Correction to: effectiveness of a high-intensive trauma-focused, family-based therapy for youth exposed to family violence: study protocol for a randomized controlled trial
Valerie Fictorie, Caroline Jonkman, Margreet Visser, Marjolein Vandenbosch, Majone Steketee, Carlo Schuengel
A single-dose, open-label, randomized, scintigraphic study to investigate the gastrointestinal behavior of 2 triple-combination cold products (acetaminophen, phenylephrine, and dextromethorphan) in healthy male volunteers
Pascal Mallefet, Marianna Armogida, Walter J. Doll, Richard C. Page, Erik P. Sandefer
Virtual Arm Boot Camp (V-ABC): study protocol for a mixed-methods study to increase upper limb recovery after stroke with an intensive program coupled with a grasp count device
Lisa A. Simpson, Ruth Barclay, Mark T. Bayley, Sean P. Dukelow, Bradley J. MacIntosh, Marilyn MacKay-Lyons, Carlo Menon, W. Ben Mortenson, Tzu-Hsuan Peng, Courtney L. Pollock, Sepideh Pooyania, Robert Teasell, Chieh-ling Yang, Jennifer Yao, Janice J. Eng
Correction to: Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol
Francisco Mera-Cordero, Sara Bonet-Monne, Jesús Almeda-Ortega, Ana García-Sangenís, Oriol Cunillera-Puèrtolas, Sara Contreras-Martos, Gemma Alvarez-Muñoz, Ramon Monfà, Marina Balanzó-Joué, Rosa Morros, Betlem Salvador-Gonzalez
Effectiveness of intravaginal electrical stimulation combined with electromyography biofeedback-mediated pelvic floor muscle training for postpartum symptomatic pelvic organ prolapse: protocol for the PROSPECT randomized trial
Li Min, Yang Chunxue, Lv Qiubo, Dong Xudong, Zhang Yan, Zhang Guifang, Hu Kejia, Gai Tianzi, Feng Qing
How are progression decisions made following external randomised pilot trials? A qualitative interview study and framework analysis
Katie Mellor, Susan J. Dutton, Sally Hopewell, Charlotte Albury
Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: study protocol for a randomized, sham-controlled clinical trial
Chi Zhao, Hui Xu, Xinyu A, Bingxin Kang, Jun Xie, Jun Shen, Songtao Sun, Sheng Zhong, Chenxin Gao, Xirui Xu, Youlong Zhou, Lianbo Xiao
Correction to: Nicotinamide riboside as a neuroprotective therapy for glaucoma: study protocol for a randomized, double-blind, placebo-control trial
Christopher Kai Shun Leung, Seraph Tianmin Ren, Poemen Pui Man Chan, Kelvin Ho Nam Wan, Aziz Ka Wai Kam, Gilda Wing Ki Lai, Vivian Sheung Man Chiu, Match Wai Lun Ko, Cedric Ka Fai Yiu, Marco Chak Yan Yu
Efficacy of active hexose correlated compound on survival of patients with resectable/borderline resectable pancreatic cancer: a study protocol for a double-blind randomized phase II study
Daisuke Hashimoto, Sohei Satoi, Hideki Ishikawa, Yasuhiro Kodera, Keiko Kamei, Satoshi Hirano, Tsutomu Fujii, Kenichiro Uemura, Akihiko Tsuchida, Suguru Yamada, Tomohisa Yamamoto, Kiichi Hirota, Mitsugu Sekimoto
ICONIC study—conservative versus conventional oxygenation targets in intensive care patients: study protocol for a randomized clinical trial
C. C. A. Grim, L. I. van der Wal, H. J. F. Helmerhorst, D. J. van Westerloo, P. Pelosi, M. J. Schultz, E. de Jonge, M. R. del Prado, J. Wigbers, M. J. Sigtermans, L. Dawson, P. L. J. van der Heijden, E. Y. Schriel-van den Berg, B. G. Loef, A. C. Reidinga, E. de Vreede, J. Qualm, E. C. Boerma, H. Rijnhart-de Jong, M. Koopmans, A. D. Cornet, T. Krol, M. Rinket, J. W. Vermeijden, A. Beishuizen, F. J. Schoonderbeek, J. van Holten, A. M. Tsonas, M. Botta, T. Winters, J. Horn, F. Paulus, M. Loconte, D. Battaglini, L. Ball, I. Brunetti
Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced uveal melanoma (CHOPIN): study protocol for a phase Ib/randomized phase II trial
T. M. L. Tong, M. K. van der Kooij, F. M. Speetjens, A. R. van Erkel, R. W. van der Meer, J. Lutjeboer, E. L. van Persijn van Meerten, C. H. Martini, R. W. M. Zoethout, F. G. J. Tijl, C. U. Blank, M. C. Burgmans, E. Kapiteijn
Statistical analysis plan for an international, double-blind, randomized controlled clinical trial on the use of phantom motor execution as a treatment for phantom limb pain
Eva Lendaro, Eric J. Earley, Max Ortiz-Catalan
Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial
Min Xu, Guangchao Zhang, Jingxuan Gong, Jing Yang
Recruitment to a large scale randomised controlled clinical trial in primary care: the Helicobacter Eradication Aspirin Trial (HEAT)
Diane J. Stevenson, Anthony J. Avery, Carol Coupland, F. D. Richard Hobbs, Denise Kendrick, Michael V. Moore, Clive Morris, Greg P. Rubin, Murray D. Smith, Christopher J. Hawkey, Jennifer S. Dumbleton
Review of the recruitment process for a large investigator-initiated trial in early Parkinson’s disease
C. V. M. Verschuur, J. L. Donovan, R. M. A. de Bie
Improving adherence to acute low back pain guideline recommendations with chiropractors and physiotherapists: the ALIGN cluster randomised controlled trial
Simon D. French, Denise A. O’Connor, Sally E. Green, Matthew J. Page, Duncan S. Mortimer, Simon L. Turner, Bruce F. Walker, Jennifer L. Keating, Jeremy M. Grimshaw, Susan Michie, Jill J. Francis, Joanne E. McKenzie
Efficacy and safety of modified Bushen Yiqi formulas (MBYF) as an add-on to formoterol and budesonide in the management of COPD: study protocol for a multicentre, double-blind, placebo-controlled, parallel-group, randomized clinical trial: FB-MBYF Trial
Qing Kong, Yuxue Cao, Zhen Gao, Jing Sun, Hongying Zhang, Yijie Du, Yubao Lv, Sihan Zhou, Zihui Tang, Baojun Liu, Jingcheng Dong
Effectiveness of an individualized home-based physical activity program in surgery-free non-endarterectomized asymptomatic stroke patients: a study protocol for the PACAPh interventional randomized trial
Mathilde Mura, Emeraude Rivoire, Leila Dehina-Khenniche, Michèle Weiss-Gayet, Bénédicte Chazaud, Camille Faes, Philippe Connes, Anne Long, Chantal L. Rytz, Pauline Mury, Lidia Delrieu, Etienne Gouraud, Marine Bordet, Nellie Della Schiava, Patrick Lermusiaux, Matthieu Arsicot, Antoine Millon, Vincent Pialoux
Improvement of participation rate in colorectal cancer (CRC) screening by training general practitioners in motivational interviewing (AmDepCCR)
Paul Aujoulat, Delphine Le Goff, Antoine Dany, Michel Robaskiewick, Jean Baptiste Nousbaum, Jeremy Derrienic, Mélanie Cariou, Morgane Guillou, Jean Yves Le Reste
Sunset Without AIDS: protocol for a randomized controlled trial of a brief video-based intervention to improve the ability of AIDS prevention in elderly men
Jianlan Ren, Mei Li, Yue Luo, Yu Zheng, Jian Tang, Ying Wang, Yanhua Chen
Diet or additional supplement to increase potassium intake: protocol for an adaptive clinical trial
Swapnil Hiremath, Dean Fergusson, Greg Knoll, Tim Ramsay, Jennifer Kong, Marcel Ruzicka
Intranasal dexamethasone: a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients
Graciela Cárdenas, María Chávez-Canales, Ana María Espinosa, Antonio Jordán-Ríos, Daniel Anica Malagon, Manlio Fabio Márquez Murillo, Laura Victoria Torres Araujo, Ricardo Leopoldo Barajas Campos, Rosa María Wong-Chew, Luis Esteban Ramirez González, Karent Ibet Cresencio, Enrique García Velázquez, Mariana Rodriguez de la Cerda, Yoana Leyva, Joselin Hernández-Ruiz, María Luisa Hernández-Medel, Mireya León-Hernández, Karen Medina Quero, Anahí Sánchez Monciváis, Sergio Hernández Díaz, Ignacia Rosalia Zeron Martínez, Adriana Martínez-Cuazitl, Iván Noé Martínez Salazar, Eduardo Beltrán Sarmiento, Aldo Figueroa Peña, Patricia Saraí Hernández, Rafel Ignacio Aguilar Reynoso, Daniela Murillo Reyes, Luis Rodrigo del Río Ambriz, Rogelio Antonio Alfaro Bonilla, Jocelyn Cruz, Leonor Huerta, Nora Alma Fierro, Marisela Hernández, Mayra Pérez-Tapia, Gabriela Meneses, Erick Espíndola-Arriaga, Gabriela Rosas, Alberto Chinney, Sergio Rosales Mendoza, Juan Alberto Hernández-Aceves, Jaquelynne Cervantes-Torres, Anai Fuentes Rodríguez, Roxana Olguin Alor, Sandra Ortega Francisco, Evelyn Alvarez Salazar, Hugo Besedovsky, Marta C. Romano, Raúl J. Bobes, Helgi Jung, Gloria Soldevila, Juan López-Alvarenga, Gladis Fragoso, Juan Pedro Laclette, Edda Sciutto
Minimising young children’s anxiety through schools (MY-CATS): protocol for a cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of an online parent-led intervention compared with usual school practice for young children identified as at risk for anxiety disorders
Tessa Reardon, Helen Dodd, Claire Hill, Bec Jasper, Peter J. Lawrence, Fran Morgan, Ronald M. Rapee, Obioha C. Ukoumunne, Mara Violato, Emily Davey, Gemma Halliday, Benjamin Jones, Lindsey Martineau, Amy McCall, Natascha Niekamp, Anna Placzek, Ruth Potts, Tamatha Weisser, Cathy Creswell
Correction to: Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection: A structured summary of a study protocol for a randomized controlled trial
Javed Akram, Shehnoor Azhar, Muhammad Shahzad, Waqas Latif, Khalid Saeed Khan
Assessing the effectiveness of a community health advisor plus screen to save educational intervention on stool-based testing adherence in an African American safety net clinic population: study protocol for a randomized pragmatic trial
John S. Luque, Olayemi O. Matthew, Deloria R. Jackson, Matthew A. Vargas, Tifini Austin, Askal Ali, Gebre E. Kiros, Cynthia M. Harris, Rima Tawk, Clement K. Gwede, Kristin Wallace, Pascal Jean-Pierre
The effects of acupuncture on psychological symptoms in patients with insomnia: study protocol for a randomized controlled trial
Lifen Wang, Ruisen Wang, Yanling Yao, Xue Bai, Gang Sheng
Fistulotomy versus standard cannulation as the primary technique for all patients undergoing ERCP with a native papilla: a protocol for a single center randomized controlled trial
Lawrence Hookey, Mandip Rai, Robert Bechara
Community-based heat-sensitive moxibustion for primary hypertension: study protocol for a randomized controlled trial with patient-preference arms
Xu Zhou, Shuqing Li, Ling Li, Guihua Deng, Li Dai, Luyu Chai, Qingni Wu, Ziqian Yao, Minchao Deng, Weifeng Zhu, Yong Fu, Xin Sun
Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial
Nigel Lee, Yu Gao, Lena B. Mårtensson, Leonie Callaway, Belinda Barnett, Sue Kildea
Electrical stimulation to prevent recurring pressure ulcers in individuals with a spinal cord injury compared to usual care: the Spinal Cord Injury PREssure VOLTage (SCI PREVOLT) study protocol
Boas J. Wijker, Sonja de Groot, Johanna M. van Dongen, Femke van Nassau, Jacinthe J. E. Adriaansen, Wendy J. Achterberg-Warmer, Johan R. Anema, Andries T. Riedstra, Maurits W. van Tulder, Thomas W. J. Janssen
Evaluation of two evidence-based decision aids for female BRCA1/2 mutation carriers in Germany: study protocol for a randomised controlled parallel-group trial
Sibylle Kautz-Freimuth, Marcus Redaèlli, Anna Isselhard, Arim Shukri, Andrea Vodermaier, Kerstin Rhiem, Rita Schmutzler, Stephanie Stock
The INVENT COVID trial: a structured protocol for a randomized controlled trial investigating the efficacy and safety of intravenous imatinib mesylate (Impentri®) in subjects with acute respiratory distress syndrome induced by COVID-19
Leila Atmowihardjo, Job R. Schippers, Imke H. Bartelink, Pierre M. Bet, Nienke van Rein, Keith Purdy, David Cavalla, Valérie Comberiati, Andrew McElroy, Sue D. Snape, Harm Jan Bogaard, Leo Heunks, Nicole Juffermans, Marcus Schultz, Pieter R. Tuinman, Lieuwe D. J. Bos, Jurjan Aman
Comparative evaluation of the efficacy of customized maxillary oral appliance with mandibular advancement appliance as a treatment modality for moderate obstructive sleep apnea patients—protocol for a randomized controlled trial
Vikram Belkhode, Surekha Godbole, Sharayu Nimonkar, Pranali Nimonkar, Sweta Pisulkar
The Opioid Analgesic Reduction Study (OARS)—a comparison of opioid vs. non-opioid combination analgesics for management of post-surgical pain: a double-blind randomized clinical trial
Cecile A. Feldman, Janine Fredericks-Younger, Shou-En Lu, Paul J. Desjardins, Hans Malmstrom, Michael Miloro, Gary Warburton, Brent Ward, Vincent Ziccardi, Daniel Fine
Animated, video entertainment-education to improve vaccine confidence globally during the COVID-19 pandemic: an online randomized controlled experiment with 24,000 participants
Simiao Chen, Sebastian Forster, Juntao Yang, Fengyun Yu, Lirui Jiao, Jennifer Gates, Zhuoran Wang, Haitao Liu, Qiushi Chen, Pascal Geldsetzer, Peixin Wu, Chen Wang, Shannon McMahon, Till Bärnighausen, Maya Adam
Effect of Tai Chi combined with Kinesio taping on posture control of football players with FAI: protocol for a randomized controlled trial
Youhua Li, Xingyue Liu, Xiwen Luo, Chunjie Guo
IMI2-PainCare-BioPain-RCT1: study protocol for a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by peripheral nerve excitability testing (NET)
Zahra Nochi, Hossein Pia, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C. Chapman, Francesca Fardo, Bernd Genser, Marcus Goetz, Anna V. Kostenko, Caterina Leone, Thomas Li, André Mouraux, Bernhard Pelz, Esther Pogatzki-Zahn, Andreas Schilder, Erik Schnetter, Karin Schubart, Alexandre Stouffs, Irene Tracey, Iñaki F. Troconiz, Andrea Truini, Johannes Van Niel, Jose Miguel Vela, Katy Vincent, Jan Vollert, Vishvarani Wanigasekera, Matthias Wittayer, Hatice Tankisi, Nanna B. Finnerup, Keith G. Phillips, Rolf-Detlef Treede
Internet-based psychotherapy in children with obsessive-compulsive disorder (OCD): protocol of a randomized controlled trial
Annette Conzelmann, Karsten Hollmann, Anna Haigis, Heinrich Lautenbacher, Verena Bizu, Rehan App, Matthias Nickola, Gunilla Wewetzer, Christoph Wewetzer, Tord Ivarsson, Norbert Skokauskas, Lidewij H. Wolters, Gudmundur Skarphedinsson, Bernhard Weidle, Else de Haan, Nor Christian Torp, Scott N. Compton, Rosa Calvo, Sara Lera-Miguel, Annika Alt, Carolin Sarah Hohnecker, Katharina Allgaier, Tobias J. Renner
The efficacy of gabapentin for the treatment of refractory cough associated with interstitial lung disease: study protocol for a randomized, double-blind and placebo-controlled clinical trial
Ronglin Gao, Xianghuai Xu, Shengyuan Wang, Jincheng Pu, Cuiqin Shi, Siwan Wen, Yiqing Zhu, Jianping Tang, Xuan Wang, Li Yu
Comparison of the procedure time differences between hybrid endoscopic submucosal dissection and conventional endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for a multi-center randomized controlled trial (Hybrid-G trial)
Mitsuru Esaki, Eikichi Ihara, Hiroyuki Fujii, Yorinobu Sumida, Kazuhiro Haraguchi, Shunsuke Takahashi, Tsutomu Iwasa, Kayoko Nakano, Masafumi Wada, Shinichi Somada, Yosuke Minoda, Haruei Ogino, Koshiro Tagawa, Yoshihiro Ogawa
Sharing individual participant data: through a systematic reviewer lens
Larysa H. M. Rydzewska, Lesley A. Stewart, Jayne F. Tierney
Prospective, randomized, controlled, double-blind, multi-center, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) sOlution versus an Electrolyte solutioN In patients undergoing eleCtive abdominal Surgery: study protocol for the PHOENICS study
Wolfgang Buhre, Dianne de Korte-de Boer, Marcelo Gama de Abreu, Thomas Scheeren, Matthias Gruenewald, Andreas Hoeft, Donat R. Spahn, Alexander Zarbock, Sylvia Daamen, Martin Westphal, Ute Brauer, Tamara Dehnhardt, Sonja Schmier, Jean-Francois Baron, Stefan De Hert, Željka Gavranović, Bernard Cholley, Tomas Vymazal, Wojciech Szczeklik, Helmar Bornemann-Cimenti, Marina Blanca Soro Domingo, Ioana Grintescu, Radmilo Jankovic, Javier Belda
Rehabilitation for children with chronic acquired brain injury in the Child in Context Intervention (CICI) study: study protocol for a randomized controlled trial
Nina Rohrer-Baumgartner, Ingvil Laberg Holthe, Edel Jannecke Svendsen, Cecilie Røe, Jens Egeland, Ida M. H. Borgen, Solveig L. Hauger, Marit V. Forslund, Cathrine Brunborg, Hege Prag Øra, Hilde Margrete Dahl, Line Kildal Bragstad, Eli Marie Killi, Maria Sandhaug, Ingerid Kleffelgård, Anine Pernille Strand-Saugnes, Ingeborg Dahl-Hilstad, Jennie Ponsford, Laraine Winter, Shari Wade, Marianne Løvstad
The effects of l-carnitine supplementation on inflammatory factors, oxidative stress, and clinical outcomes in patients with sepsis admitted to the intensive care unit (ICU): study protocol for a double blind, randomized, placebo-controlled clinical trial
Mahdi Keshani, Babak Alikiaii, Gholamreza Askari, Farveh Yahyapoor, Gordon A. Ferns, Mohammad Bagherniya
Efficacy and safety of Tengfu Jiangya tablet combined with valsartan/amlodipine in the treatment of stage 2 hypertension: study protocol for a randomized controlled trial
Yu Wang, Zhen Hua, Wenjing Chen, Yushuo Zhu, Yunlun Li
Comparing the efficacy and safety of minimally invasive biportal endoscopic spine surgery versus conventional microscopic discectomy in single-level lumbar herniated intervertebral disc (ENDO-BH Trial): a multicenter, prospective, randomized controlled equivalence trial study protocol
Sang-Min Park, Kwang-Sup Song, Ho-Joong Kim, Si-Young Park, Taewook Kang, Min-Seok Kang, Dong Hwa Heo, Choon Keun Park, Dong-Geun Lee, Jin Sub Hwang, Jae-Won Jang, Jun Young Kim, Jin-Sung Kim, Hong-Jae Lee, Ki-Han You, Hyun-Jin Park
Transfer of FRozen Encapsulated multi-donor Stool filtrate for active ulcerative Colitis (FRESCO): study protocol for a prospective, multicenter, double-blind, randomized, controlled trial
Andreas Stallmach, Philip Grunert, Johannes Stallhofer, Bettina Löffler, Michael Baier, Jürgen Rödel, Michael Kiehntopf, Sophie Neugebauer, Dietmar H. Pieper, Howard Junca, Andrea Tannapfel, Ute Merkel, Ulrike Schumacher, Maria Breternitz-Gruhne, Tabitha Heller, Anja Schauer, Michael Hartmann, Arndt Steube
CeRebrUm and CardIac Protection with ALlopurinol in Neonates with Critical Congenital Heart Disease Requiring Cardiac Surgery with Cardiopulmonary Bypass (CRUCIAL): study protocol of a phase III, randomized, quadruple-blinded, placebo-controlled, Dutch multicenter trial
Raymond Stegeman, Maaike Nijman, Johannes M. P. J. Breur, Floris Groenendaal, Felix Haas, Jan B. Derks, Joppe Nijman, Ingrid M. van Beynum, Yannick J. H. J. Taverne, Ad J. J. C. Bogers, Willem A. Helbing, Willem P. de Boode, Arend F. Bos, Rolf M. F. Berger, Ryan E. Accord, Kit C. B. Roes, G. Ardine de Wit, Nicolaas J. G. Jansen, Manon J. N. L. Benders
Study protocol for a cluster randomized trial of a school, family, and community intervention for preventing drug misuse among older adolescents in the Cherokee Nation
Kelli A. Komro, Terrence K. Kominsky, Juli R. Skinner, Melvin D. Livingston, Bethany J. Livingston, Kristin Avance, Ashley N. Lincoln, Caroline M. Barry, Andrew L. Walker, Dallas W. Pettigrew, Lisa J. Merlo, Hannah L. F. Cooper, Alexander C. Wagenaar
A multiple technology-based physical activity intervention for Latina adolescents in the USA: randomized controlled trial study protocol for Chicas Fuertes
Britta Larsen, Emily Greenstadt, Brittany Olesen, Lilliana Osuna, Job Godino, Bess Marcus, Shira Dunsiger, Dawn Meyer, Michelle Zive
The “Blood pressure and oxygenation targets in post resuscitation care, a randomized clinical trial”: design and statistical analysis plan
Jesper Kjaergaard, Henrik Schmidt, Jacob E. Møller, Christian Hassager
Effect of fecal microbiota transplantation on primary hypertension and the underlying mechanism of gut microbiome restoration: protocol of a randomized, blinded, placebo-controlled study
Luyun Fan, Jie Ren, Youren Chen, Yang Wang, Zihong Guo, Peili Bu, Jinfeng Yang, Wenjun Ma, Bingpo Zhu, Yanyan Zhao, Jun Cai
Effect of omega-3 fatty acids on TH1/TH2 polarization in individuals with high exposure to particulate matter ≤ 2.5 μm (PM2.5): a randomized, double-blind, placebo-controlled clinical study
Xiaomin Wang, Shuiqin Li, Yongcan Wu, Demei Huang, Caixia Pei, Yilan Wang, Shihua Shi, Fei Wang, Zhenxing Wang
The effect of probiotic cheese consumption on inflammatory and anti-inflammatory markers, disease severity, and symptoms in patients with rheumatoid arthritis: study protocol for a randomized, double-blind, placebo-controlled trial
Farzaneh Asoudeh, Kurosh Djafarian, Maassoumeh Akhalghi, Mahdi Mahmoudi, Ahmad Reza Jamshidi, Elham Farhadi, Ahmad Esmaillzadeh
Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction—BAMPI TRIAL: an open-label, randomized controlled trial protocol
Albert Garcia-Sumalla, Carme Loras, Vicente Sanchiz, Rafael Pedraza Sanz, Enrique Vazquez-Sequeiros, Jose Ramon Aparicio, Carlos de la Serna-Higuera, Daniel Luna-Rodriguez, Xavier Andujar, María Capilla, Tatiana Barberá, Jose Ramon Foruny-Olcina, Belen Martínez, Miguel Dura, Silvia Salord, Berta Laquente, Cristian Tebe, Sebastia Videla, Manuel Perez-Miranda, Joan B. Gornals
The effects of high-intensity functional training on cardiometabolic risk factors and exercise enjoyment in men and women with metabolic syndrome: study protocol for a randomized, 12-week, dose-response trial
L. E. Smith, G. P. Van Guilder, L. C. Dalleck, N. K. Harris
Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): protocol for a cluster-randomised controlled trial testing the effect women’s groups, home counselling and iron supplementation on haemoglobin in pregnancy in southern Nepal
Naomi M. Saville, Chandani Kharel, Joanna Morrison, Helen Harris-Fry, Philip James, Andrew Copas, Santosh Giri, Abriti Arjyal, B. James Beard, Hassan Haghparast-Bidgoli, Jolene Skordis, Adam Richter, Sushil Baral, Sara Hillman
PAciFy Cough—a multicentre, double-blind, placebo-controlled, crossover trial of morphine sulphate for the treatment of pulmonary Fibrosis Cough
Zhe Wu, Winston Banya, Nazia Chaudhuri, Ira Jakupovic, Toby M. Maher, Brijesh Patel, Lisa G. Spencer, Muhunthan Thillai, Alex West, John Westoby, Marlies Wijsenbeek, Jaclyn Smith, Philip L. Molyneaux
EVITA Dengue: a cluster-randomized controlled trial to EValuate the efficacy of Wolbachia-InfecTed Aedes aegypti mosquitoes in reducing the incidence of Arboviral infection in Brazil
Matthew H. Collins, Gail E. Potter, Matt D. T. Hitchings, Ellie Butler, Michelle Wiles, Jessie K. Kennedy, Sofia B. Pinto, Adla B. M. Teixeira, Arnau Casanovas-Massana, Nadine G. Rouphael, Gregory A. Deye, Cameron P. Simmons, Luciano A. Moreira, Mauricio L. Nogueira, Derek A. T. Cummings, Albert I. Ko, Mauro M. Teixeira, Srilatha Edupuganti
Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: a regionally based randomised trial of an integrated response to suicide risk among secondary school students
Sadhbh J. Byrne, Eleanor Bailey, Michelle Lamblin, Samuel McKay, Jane Pirkis, Cathrine Mihalopoulos, Matthew J. Spittal, Simon Rice, Sarah Hetrick, Matthew Hamilton, Hok Pan Yuen, Yong Yi Lee, Alexandra Boland, Jo Robinson
Data management in diabetes clinical trials: a qualitative study
Aynaz Nourani, Haleh Ayatollahi, Masoud Solaymani Dodaran
Immediate effects of spinal manipulation on painful sensitivity and postural stability in patients with chronic nonspecific low back pain: study protocol for a controlled randomised clinical trial
João Paulo Freitas, Leticia Amaral Corrêa, Juliana Valentim Bittencourt, Karine Marcondes Armstrong, Leandro Alberto Calazans Nogueira
Efficacy and safety of long-term transcutaneous electroacupuncture versus sham transcutaneous electroacupuncture for delayed gastric emptying after distal gastrectomy: study protocol for a randomized, patient-assessor blinded, controlled trial
Kai-Bo Chen, Zhi-Wei Wu, Jun Wang, Ling-Hua Zhu, Xiao-Li Jin, Guo-Feng Chen, Mu-Xing Kang, Yi Huang, Hang Zhang, Le-Le Lin, Di-Ke Shi, Dan Wu, Jian-Feng Chen, Jian Chen, Zhi-Qing Zhao
Does m-health-based exercise (guidance plus education) improve efficacy in patients with chronic low-back pain? A preliminary report on the intervention’s significance
Fuming Zheng, Shufeng Liu, Shanshan Zhang, Qiuhua Yu, Wai Leung Ambrose Lo, Tingni Li, Chu Huai Wang
Effect of first dorsal interosseous strengthening on clinical outcomes in patients with thumb osteoarthritis: a study protocol for a randomized controlled clinical trial
Natália Barbosa Tossini, Natália Duarte Pereira, Gabriela Sardeli de Oliveira, Paula Regina Mendes da Silva Serrão
The effects of remifentanil-propofol combined with dexmedetomidine on cognitive dysfunction in elderly patients after ureteroscopic holmium laser lithotripsy: a double-blind randomized controlled trial
Fangjun Wang, Dan Xie, Hongchun Xu, Qin Ye, Le Wu, Xiao Pei Gao
A phase III randomized trial of weight loss to reduce cancer-related fatigue among overweight and obese breast cancer patients: MEDEA Study design
Antonio Di Meglio, Elise Martin, Tracy E. Crane, Cecile Charles, Aude Barbier, Bruno Raynard, Anthony Mangin, Olivier Tredan, Carole Bouleuc, Paul H. Cottu, Laurence Vanlemmens, Carine Segura-Djezzar, Anne Lesur, Barbara Pistilli, Florence Joly, Thomas Ginsbourger, Bernadette Coquet, Iris Pauporte, Guillemette Jacob, Aude Sirven, Julia Bonastre, Jennifer A. Ligibel, Stefan Michiels, Ines Vaz-Luis
LIBERATE: a study protocol for midodrine for the early liberation from vasopressor support in the intensive care unit (LIBERATE): protocol for a randomized controlled trial
Dawn Opgenorth, Nadia Baig, Kirsten Fiest, Constantine Karvellas, Jim Kutsogiannis, Vincent Lau, Erika Macintyre, Janek Senaratne, Jocelyn Slemko, Wendy Sligl, Xiaoming Wang, Sean M. Bagshaw, Oleksa G. Rewa
Trauma-focused EMDR for Personality disorders among Outpatients (TEMPO): study protocol for a multi-centre, single-blind, randomized controlled trial
Simon Hofman, Laurian Hafkemeijer, Ad de Jongh, Annemieke Starrenburg, Karin Slotema
Prospective preference assessment for the Comparison of Analgesic Regimen Effectiveness and Safety in Surgery (CARES) trial
Brian Hyung, Mark C. Bicket, Richard Brull, Janneth Pazmino-Canizares, Didem Bozak, Karim S. Ladha
Ceftriaxone to PRevent pneumOnia and inflammaTion aftEr Cardiac arresT (PROTECT): study protocol for a randomized, placebo-controlled trial
David J. Gagnon, Sergey V. Ryzhov, Meghan A. May, Richard R. Riker, Bram Geller, Teresa L. May, Sarah Bockian, Joanne T. deKay, Ashley Eldridge, Thomas Van der Kloot, Patricia Lerwick, Christine Lord, F. Lee Lucas, Patrick Mailloux, Barbara McCrum, Meghan Searight, Joel Wirth, Jonathan Zuckerman, Douglas Sawyer, David B. Seder
PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial
F. Coccolini, A. Tarasconi, G. L. Petracca, G. Perrone, M. Giuffrida, C. Disisto, M. Sartelli, P. Carcoforo, L. Ansaloni, F. Catena
Patient-centred outcomes are under-reported in the critical care burns literature: a systematic review
Karthik Venkatesh, Alice Henschke, Richard P. Lee, Anthony Delaney
Effects of transcranial direct current stimulation on patients with post-stroke fatigue: a study protocol for a double-blind randomized controlled trial
Xing Sun, Xiangli Dong, Qin Yuan, Guohua Yu, Lang Shuai, Chaolin Ma, Weiming Sun
The effect of tourniquet application on the morphology and function of quadriceps in patients undergoing total knee arthroplasty: study protocol for a single-blind randomized controlled trial
Ziyang Dong, Yang Li, Liyuan Tao, Hua Tian
Non-inferiority test for a continuous variable with a flexible margin in an active controlled trial: an application to the “Stratall ANRS 12110 / ESTHER” trial
Arsene Brunelle Sandie, Nicolas Molinari, Anthony Wanjoya, Charles Kouanfack, Christian Laurent, Jules Brice Tchatchueng-Mbougua
A randomized non-inferiority study of low-dose and standard-dose ticagrelor after intervention for acute coronary syndrome: study protocol for the TIGER STUDY
Yanan Pang, Minglu Ma, Jiachun Xia, Dong Wang, YanChen, Jianfei Ye, Zhongwei Jia, Sicheng Wu, Jian Yang, Lei Hou
Study protocol for a cluster randomised trial of sterile glove and instrument change at the time of wound closure to reduce surgical site infection in low- and middle-income countries (CHEETAH)
Adesoji O Ademuyiwa, Adewale O. Adisa, Aneel Bhangu, Peter Brocklehurst, Sohini Chakrabortee, Dhruva Ghosh, James Glasbey, Parvez D Haque, Pollyanna Hardy, Ewen Harrison, JC Allen Ingabire, Lawani Ismail, Bryar Kadir, Rachel Lillywhite, Laura Magill, Antonio Ramos de la Medina, Rachel Moore, Mark Monahan, Dion Morton, Dmitri Nepogodiev, Faustin Ntirenganya, Omar Omar, Thomas Pinkney, Donna Smith, Stephen Tabiri, Neil Winkles
The People’s Trial: supporting the public’s understanding of randomised trials
Elaine Finucane, Ann O’Brien, Shaun Treweek, John Newell, Kishor Das, Sarah Chapman, Paul Wicks, Sandra Galvin, Patricia Healy, Linda Biesty, Katie Gillies, Anna Noel-Storr, Heidi Gardner, Mary Frances O’Reilly, Declan Devane
Laparoscopic versus open resections in the posterosuperior liver segments within an enhanced recovery programme (ORANGE Segments): study protocol for a multicentre randomised controlled trial
Christoph Kuemmerli, Robert S. Fichtinger, Alma Moekotte, Luca A. Aldrighetti, Somaiah Aroori, Marc G. H. Besselink, Mathieu D’Hondt, Rafael Díaz-Nieto, Bjørn Edwin, Mikhail Efanov, Giuseppe M. Ettorre, Krishna V. Menon, Aali J. Sheen, Zahir Soonawalla, Robert Sutcliffe, Roberto I. Troisi, Steven A. White, Lloyd Brandts, Gerard J. P. van Breukelen, Jasper Sijberden, Siân A. Pugh, Zina Eminton, John N. Primrose, Ronald van Dam, Mohammed Abu Hilal
Correction: Virtual Arm Boot Camp (V-ABC): study protocol for a mixed-methods study to increase upper limb recovery after stroke with an intensive program coupled with a grasp count device
Lisa A. Simpson, Ruth Barclay, Mark T. Bayley, Sean P. Dukelow, Bradley J. MacIntosh, Marilyn MacKay-Lyons, Carlo Menon, W. Ben Mortenson, Tzu-Hsuan Peng, Courtney L. Pollock, Sepideh Pooyania, Robert Teasell, Chieh-ling Yang, Jennifer Yao, Janice J. Eng
Caries inhibition with CO2-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial
Ani Bozhidarova Belcheva, Maria Petrova Shindova
Differentiated prevention and care to reduce the risk of HIV acquisition and transmission among female sex workers in Zimbabwe: study protocol for the ‘AMETHIST’ cluster randomised trial
Frances M. Cowan, Fortunate Machingura, Sungai T. Chabata, M. Sanni Ali, Joanna Busza, Richard Steen, Nicola Desmond, Maryam Shahmanesh, Paul Revill, Amon Mpofu, Raymond Yekeye, Owen Mugurungi, Andrew N. Phillips, James R. Hargreaves
Tolerance induction through early feeding to prevent food allergy in infants with eczema (TEFFA): rationale, study design, and methods of a randomized controlled trial
Birgit Kalb, Lara Meixner, Valérie Trendelenburg, Nathalie Unterleider, Josefine Dobbertin-Welsch, Stephanie Heller, Sabine Dölle-Bierke, Stephanie Roll, Susanne Lau, Young-Ae Lee, Florent Fauchère, Julian Braun, Magda Babina, Sabine Altrichter, Till Birkner, Margitta Worm, Kirsten Beyer
SOX combined with intraperitoneal perfusion of docetaxel compared with DOS regimen in the first-line therapy for advanced gastric cancer with malignant ascites: a prospective observation
Yehong Bin, Dong Lan, Wenguang Bao, Haiyan Yang, Shengsheng Zhou, Fengxiang Huang, Man Wang, Zhigang Peng
OPAL: a randomised, placebo-controlled trial of opioid analgesia for the reduction of pain severity in people with acute spinal pain—a statistical analysis plan
Caitlin MP Jones, Chung-Wei Christine Lin, Richard O. Day, Bart W. Koes, Jane Latimer, Chris G. Maher, Andrew McLachlan, Laurent Billot
Postoperative drainage for 6, 12, or 24 h after burr-hole evacuation of chronic subdural hematoma in symptomatic patients (DRAIN-TIME 2): study protocol for a nationwide randomized controlled trial
Mads Hjortdal Grønhøj, Thorbjørn Søren Rønn Jensen, Ann Kathrine Sindby, Rares Miscov, Torben Hundsholt, Birgit Debrabant, Carsten Reidies Bjarkam, Bo Bergholt, Kåre Fugleholm, Frantz Rom Poulsen
Correction to: Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction—BAMPI TRIAL: an open-label, randomized controlled trial protocol
Albert Garcia-Sumalla, Carme Loras, Vicente Sanchiz, Rafael Pedraza Sanz, Enrique Vazquez-Sequeiros, Jose Ramon Aparicio, Carlos de la Serna-Higuera, Daniel Luna-Rodriguez, Xavier Andujar, María Capilla, Tatiana Barberá, Jose Ramon Foruny-Olcina, Belen Martínez, Miguel Dura, Silvia Salord, Berta Laquente, Cristian Tebe, Sebastia Videla, Manuel Perez-Miranda, Joan B. Gornals
Effect of application time of 38% silver diamine fluoride solution on arresting early childhood caries in preschool children: a randomised double-blinded controlled trial protocol
Iliana Gehui Yan, Faith Miaomiao Zheng, Sherry Shiqian Gao, Duangporn Duangthip, Edward Chin Man Lo, Chun Hung Chu
Electro-acupuncture for protracted amphetamine abstinence syndrome: study protocol for a pragmatic randomized controlled trial
Huan Ren, Yiwei Zeng, Min Zhang, Su Zhang, Zhihan Chen, Binbin Wu, Jun Liu, Yulan Ren
Effectiveness of herb-partitioned moxibustion on the navel for pregnancy outcomes in patients with recurrent implantation failure undergoing in vitro fertilization and embryo transfer: a study protocol for a randomized controlled trial
Qingchang Xia, Shuzhong Gao, Jingyan Song, Dongqing Du, Chunjing Li, Yue Zhou, Xiaobin Zhang, Zhibin Dong, Yuning Ma, Yuxia Ma
Effectiveness of an adapted diving mask (Owner mask) for non-invasive ventilation in the COVID-19 pandemic scenario: study protocol for a randomized clinical trial
Dulciane Nunes Paiva, Litiele Evelin Wagner, Sônia Elvira dos Santos Marinho, Carlos Fernando Drumond Dornelles, Juliana Fernandes de Souza Barbosa, Patrícia Érika de Melo Marinho
The influence of TIVA or inhalation anesthesia with or without intravenous lidocaine on postoperative outcome in colorectal cancer surgery: a study protocol for a prospective clinical study
Alexandru L. Alexa, Tiberiu F. Tat, Daniela Ionescu
Postpartum haemorrhage in anaemic women: assessing outcome measures for clinical trials
Amy Brenner, Ian Roberts, Eni Balogun, Folasade Adenike Bello, Rizwana Chaudhri, Charlotte Fleming, Kiran Javaid, Aasia Kayani, Mwansa Ketty Lubeya, Raoul Mansukhani, Oladapo Olayemi, Danielle Prowse, Bellington Vwalika, Haleema Shakur-Still
Efficacy of a new membrane obturator prosthesis in terms of speech, swallowing, and the quality of life of patients with acquired soft palate defects: study protocol of the VELOMEMBRANE randomized crossover trial
Adrien Naveau, Marion Kret, Valérie Plaire, Olivier Delorme, Sébastien Marchi, Caroline de Bataille, Florent Destruhaut, Elise Arrive, Christophe Bou
Cytokine adsorption in patients with acute-on-chronic liver failure (CYTOHEP)—a single center, open-label, three-arm, randomized, controlled intervention trial
Asieb Sekandarzad, Enya Weber, Eric Peter Prager, Erika Graf, Dominik Bettinger, Tobias Wengenmayer, Alexander Supady
Efficacy of approach bias modification as an add-on to smoking cessation treatment: study protocol for a randomized-controlled double-blind trial
Charlotte E. Wittekind, Keisuke Takano, Philipp Sckopke, Markus H. Winkler, Gabriela G. Werner, Thomas Ehring, Tobias Rüther
Pediatric specific challenges of the single institutional review board mandate
Andrew Hu, Jane L. Holl, Mehul V. Raval
Financially incentivized knowledge assessments to improve provider compliance with treatment guidelines: a cluster-randomized controlled trial
Günther Fink, György Fritsche, Hadia Samaha, Claude Sese, Gil Shapira
Maximising recruitment of research participants into a general practice based randomised controlled trial concerning lung diagnosis—staff insights from an embedded qualitative study
Hayley Prout, Angela Tod, Richard Neal, Annmarie Nelson
Chinese herbal formula Tongxie Yaofang for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized, multiple-blind, placebo-controlled trial
Shi-Bing Liang, Mei Han, Hong-Jie Cheng, Qiao-Yan Zhang, Nai-Wei Zhang, Bo-Yi Jia, Nicola Robinson, Jian-Ping Liu
Effectiveness of a mobile app-based educational intervention to treat internet gaming disorder among Iranian adolescents: study protocol for a randomized controlled trial
Amir H. Pakpour, Sara Fazeli, Isa Mohammadi Zeidi, Zainab Alimoradi, Mattias Georgsson, Anders Brostrom, Marc N. Potenza
Minimal effective dose of ultrasound-guided rectus sheath block to reduce oral analgesic requirement after ambulatory laparoscopic tubal resection: a randomized controlled superiority trial
Sirikarn Siripruekpong, Jinsupha Aphinyankul, Thavat Chanchayanon, Maliwan Oofuvong, Jatupon Pakpirom, Chainarong Choksuchat, Patrapon Packawatchai, Jumras Na Klongdee
Correction to: Effectiveness of an individualized home-based physical activity program in surgery-free non-endarterectomized asymptomatic stroke patients: a study protocol for the PACAPh interventional randomized trial
Mathilde Mura, Emeraude Rivoire, Leila Dehina-Khenniche, Michèle Weiss-Gayet, Bénédicte Chazaud, Camille Faes, Philippe Connes, Anne Long, Chantal L. Rytz, Pauline Mury, Lidia Delrieu, Etienne Gouraud, Marine Bordet, Nellie Della Schiava, Patrick Lermusiaux, Matthieu Arsicot, Antoine Millon, Vincent Pialoux
Effect of vaginal antiseptic prior to caesarean section on the rate of post-caesarean complications: a blinded randomised controlled trial
Monika Trivedi, Ainsley M. Robinson, Md Rafiqul Islam
Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a study protocol for a multicentre adaptive randomised controlled trial
Melissa Earwaker, Sofia Villar, Julia Fox-Rushby, Melissa Duckworth, Sarah Dawson, Jo Steele, Yi-da Chiu, Edward Litton, Gudrun Kunst, Gavin Murphy, Guillermo Martinez, Vasileios Zochios, Val Brown, Geoff Brown, Andrew Klein
Social network-based group intervention to promote HIV prevention in Uganda: study protocol for a cluster randomized controlled trial of Game Changers
Glenn J. Wagner, Laura M. Bogart, Harold D. Green, Erik D. Storholm, David J. Klein, Ryan K. McBain, Richard Serunkuuma, Kuraish Mubiru, Joseph K. B. Matovu, Stephen Okoboi
The efficacy of temozolomide combined with levetiracetam for glioblastoma (GBM) after surgery: a study protocol for a double-blinded and randomized controlled trial
Maoyuan Sun, Ning Huang, Yihao Tao, Rong Wen, Guanjian Zhao, Xiang Zhang, Zongyi Xie, Yuan Cheng, Jinning Mao, Guodong Liu
Retention in RCTs of physical rehabilitation for adults with frailty: a systematic review and meta-analysis
Heather K. O’Grady, Christopher Farley, Alyson Takaoka, Elisa Mayens, Jackie Bosch, Lyn Turkstra, Michelle E. Kho
Tolerance induction through non-avoidance to prevent persistent food allergy (TINA) in children and adults with peanut or tree nut allergy: rationale, study design and methods of a randomized controlled trial and observational cohort study
Valérie Trendelenburg, Sabine Dölle-Bierke, Nathalie Unterleider, Aikaterina Alexiou, Birgit Kalb, Lara Meixner, Stephanie Heller, Susanne Lau, Young- Ae Lee, Florent Fauchère, Julian Braun, Magda Babina, Sabine Altrichter, Till Birkner, Stephanie Roll, Josefine Dobbertin-Welsch, Margitta Worm, Kirsten Beyer
Clinical- and cost-effectiveness of a technology-supported and solution-focused intervention (DIALOG+) in treatment of patients with chronic depression—study protocol for a multi-site, cluster randomised controlled trial [TACK]
Philip McNamee, Aleksandra Matanov, Lauren Jerome, Sally Kerry, Neil Walker, Yan Feng, Andrew Molodynski, Shonagh Scott, Latha Guruvaiah, Sue Collinson, Rose McCabe, John Geddes, Stefan Priebe, Victoria Bird
Electrical dry needling versus conventional physiotherapy in the treatment of active and latent myofascial trigger points in patients with nonspecific chronic low back pain
Inmaculada Carmen Lara-Palomo, Esther Gil-Martínez, Eduardo Antequera-Soler, Adelaida María Castro-Sánchez, Manuel Fernández-Sánchez, Héctor García-López
Developing a core outcome set for assessing clinical safety outcomes of cardiovascular diseases in clinical trials of integrated traditional Chinese medicine and Western medicine: study protocol
Ruijin Qiu, Changming Zhong, Siqi Wan, Yao Zhang, Xuxu Wei, Min Li, Jiayuan Hu, Shiqi Chen, Chen Zhao, Zhao Chen, Jing Chen, Hongcai Shang
Super Bolus: a remedy for a high glycemic index meal in children with type 1 diabetes on insulin pump therapy?—study protocol for a randomized controlled trial
Emilia Kowalczyk, Katarzyna Dżygało, Agnieszka Szypowska
The application of augmented reality in craniofacial bone fracture reduction: study protocol for a randomized controlled trial
Li Lin, Xiangqi Liu, Yuan Gao, Zin Mar Aung, Haisong Xu, Bingshun Wang, Le Xie, Xianxian Yang, Gang Chai
Randomized Evaluation of Surgery in Elderly with Traumatic Acute SubDural Hematoma (RESET-ASDH trial): study protocol for a pragmatic randomized controlled trial with multicenter parallel group design
Ranjit D. Singh, Jeroen T. J. M. van Dijck, Thomas A. van Essen, Hester F. Lingsma, Suzanne S. Polinder, Erwin J. O. Kompanje, Erik W. van Zwet, Ewout W. Steyerberg, Godard C. W. de Ruiter, Bart Depreitere, Wilco C. Peul
Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement
Laura A. Meis, Shirley M. Glynn, Michele R. Spoont, Shannon M. Kehle-Forbes, David Nelson, Carl E. Isenhart, Afsoon Eftekhari, Princess E. Ackland, Erin B. Linden, Robert J. Orazem, Andrea Cutting, Emily M. Hagel Campbell, Millie C. Astin, Katherine E. Porter, Erin Smith, Christopher D. Chuick, Kristen E. Lamp, Tessa C. Vuper, Taylor A. Oakley, Lila B. Khan, Sally K. Keckeisen, Melissa A. Polusny
The One Nutrition in Complex Environments (ONCE) study protocol: a cluster-randomized multi-level multi-sectoral intervention to improve nutrition in Uganda
Stacy P. Griswold, Anastasia Marshak, Merry Fitzpatrick, Daniele Lantagne, Kate Shoenmakers, Marlene Hebie, Anne Radday, Hugo De Groote, Saurabh Mehta, Greg Gottlieb, Patrick Webb, Shibani Ghosh
The effect of extracorporeal shock wave therapy in acute traumatic spinal cord injury on motor and sensory function within 6 months post-injury: a study protocol for a two-arm three-stage adaptive, prospective, multi-center, randomized, blinded, placebo-controlled clinical trial
Iris Leister, Rainer Mittermayr, Georg Mattiassich, Ludwig Aigner, Thomas Haider, Lukas Machegger, Harald Kindermann, Anja Grazer-Horacek, Johannes Holfeld, Wolfgang Schaden
Pragmatic trials can address diagnostic controversies: recent lessons from gestational diabetes
Jean Raymond, Hélène Long, Tim Darsaut
Live birth after letrozole as an adjunct to follicle-stimulating hormone versus follicle-stimulating hormone alone for ovarian stimulation in in vitro fertilisation cycles—study protocol for a randomised controlled trial
Wei Guo, Hang Wun Raymond Li, Zi Yang, Lin Zeng, Rui Yang, Jie Qiao, Rong Li, Ernest Hung Yu Ng
Oral Huzhang granules for the treatment of acute gouty arthritis: protocol for a double-blind, randomized, controlled trial
Mi Zhou, Liang Hua, Yi-Fei Wang, Si-Ting Chen, Chun-mei Yang, Ming Zhang, Xin Li, Bin Li
Development of a core outcome set for effectiveness studies of breech birth at term (Breech-COS)—an international multi-stakeholder Delphi study: study protocol
Shawn Walker, Tisha Dasgupta, Andrew Shennan, Jane Sandall, Catey Bunce, Phoebe Roberts
A randomised controlled trial investigating the clinical and cost-effectiveness of Alpha-Stim AID cranial electrotherapy stimulation (CES) in patients seeking treatment for moderate severity depression in primary care (Alpha-Stim-D Trial)
Shireen Patel, Clement Boutry, Priya Patel, Michael P. Craven, Boliang Guo, Azhar Zafar, Joe Kai, David Smart, Debbie Butler, Fred Higton, Rebecca McNaughton, Paul M. Briley, Chris Griffiths, Neil Nixon, Kapil Sayal, Richard Morriss
Comparing Sugarbaker versus keyhole mesh technique for open retromuscular parastomal hernia repair: study protocol for a registry-based randomized controlled trial
Benjamin T. Miller, Jonah D. Thomas, Chao Tu, Adele Costanzo, Lucas R. A. Beffa, David M. Krpata, Ajita S. Prabhu, Michael J. Rosen, Clayton C. Petro
Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate to severe ARDS in a randomized, placebo-controlled, double-blind trial: preliminary evaluation of safety and feasibility in light of the COVID-19 pandemic
Benedikt Schmid, Peter Kranke, Rudolf Lucas, Patrick Meybohm, Bernhard Zwissler, Sandra Frank
Development of an information system and mobile application for the care of type 2 diabetes patients at the primary care level for the health sector in Mexico: study protocol for a randomized controlled, open-label trial
Noël C. Barengo, Leticia Manuel Apolinar, Norma A. Estrada Cruz, José E. Fernández Garate, Roberto A. Correa González, Paula A. Diaz Valencia, Cecilia Alicia Cinco Gonzalez, José Alberto Gómez Rodriguez, Nelly Cisneros González, Maria L. Arellano Flores, Mercedes E. Ledesma Muñoz, Diana A. Gonzalez Sotelo, Oscar M. Davila Maldonado, Jhoana G. Gomez Garcia, Francisco J. Laureano Hernandez, Julio Eduardo Zarazua Jimenez, Brenda A. Pulido Garcia, Hector Rodriguez Vazquez, Alexis A. Ramirez Dorantes, Liliana A. Gonzalez Fierro, Juan C. Hernandez Hernandez, Jorge Zenil Perez
Recruitment of young adult cancer survivors into a randomized controlled trial of an mHealth physical activity intervention
Carmina G. Valle, Lindsey N. Camp, Molly Diamond, Brooke T. Nezami, Jessica Gokee LaRose, Bernardine M. Pinto, Deborah F. Tate
The use of standardized Brazilian green propolis extract (EPP-AF) as an adjunct treatment for hospitalized COVID-19 patients (BeeCovid2): a structured summary of a study protocol for a randomized controlled trial
Marcelo Augusto Duarte Silveira, Sergio Pinto de Souza, Erica Batista dos Santos Galvão, Maurício Brito Teixeira, Marcel Miranda Dantas Gomes, Lucas Petri Damiani, Bruno Andrade Bahiense, Julia Barros Cabral, Cicero Wandson Luiz Macedo De Oliveira, Talita Rocha Mascarenhas, Priscila Carvalho Guedes Pinheiro, Milena Souza Alves, Rodrigo Morel Vieira de Melo, Andresa Aparecida Berretta, Flávia Mendes Leite, Carolina Kymie Vasques Nonaka, Bruno Solano de Freitas Souza, Ana Verena Almeida Mendes, Suzete Farias da Guarda, Rogério da Hora Passos
A deprescribing medication program to evaluate falls in older adults: methods for a randomized pragmatic clinical trial
Joshua Niznik, Stefanie P. Ferreri, Lori Armistead, Benjamin Urick, Mary-Haston Vest, Liang Zhao, Tamera Hughes, J. Marvin McBride, Jan Busby-Whitehead
Development of a new adapted QuinteT Recruitment Intervention (QRI-Two) for rapid application to RCTs underway with enrolment shortfalls—to identify previously hidden barriers and improve recruitment
Jenny L. Donovan, Marcus Jepson, Leila Rooshenas, Sangeetha Paramasivan, Nicola Mills, Daisy Elliott, Julia Wade, Domenic Reda, Jane M. Blazeby, Drew Moghanaki, E. Shelley Hwang, Louise Davies
The Mirasol Evaluation of Reduction in Infections Trial (MERIT): study protocol for a randomized controlled clinical trial
Ronnie Kasirye, Heather A. Hume, Evan M. Bloch, Irene Lubega, Dorothy Kyeyune, Ruchee Shrestha, Henry Ddungu, Hellen Wambongo Musana, Aggrey Dhabangi, Joseph Ouma, Priscilla Eroju, Telsa de Lange, Michael Tartakovsky, Jodie L. White, Ceasar Kakura, Mary Glenn Fowler, Philippa Musoke, Monica Nolan, M. Kate Grabowski, Lawrence H. Moulton, Susan L. Stramer, Denise Whitby, Peter A. Zimmerman, Deo Wabwire, Isaac Kajja, Jeffrey McCullough, Raymond Goodrich, Thomas C. Quinn, Robert Cortes, Paul M. Ness, Aaron A. R. Tobian
Evaluation of the protective efficacy of a spatial repellent to reduce malaria incidence in children in Mali compared to placebo: study protocol for a cluster-randomized double-blinded control trial (the AEGIS program)
Suzanne Van Hulle, Issaka Sagara, Momar Mbodji, Ghislain Ismael Nana, Mamadou Coulibaly, Alassane Dicko, Mamady Kone, Ismaila Thera, Daman Sylla, Mamadou Diango Traore, Fang Liu, John P. Grieco, Nicole L. Achee
Evaluation of the protective efficacy of a spatial repellent to reduce malaria incidence in children in western Kenya compared to placebo: study protocol for a cluster-randomized double-blinded control trial (the AEGIS program)
Eric O. Ochomo, John E. Gimnig, Achuyt Bhattarai, Aaron M. Samuels, Simon Kariuki, George Okello, Bernard Abong’o, Eunice A. Ouma, Jackline Kosgei, Stephen Munga, Kiambo Njagi, Wycliffe Odongo, Fang Liu, John P. Grieco, Nicole L. Achee
DICE: Dual mTorc Inhibition in advanCed/recurrent Epithelial ovarian cancer resistant to standard treatment—a study protocol for a randomised trial investigating a novel therapy called TAK228
Francesca Fiorentino, Jonathan Krell, Consuelo Nohpal de la Rosa, Lee Webber
Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke
Na Jin Seo, Viswanathan Ramakrishnan, Michelle L. Woodbury, Leonardo Bonilha, Christian Finetto, Christian Schranz, Gabrielle Scronce, Kristen Coupland, Jenna Blaschke, Adam Baker, Keith Howard, Caitlyn Meinzer, Craig A. Velozo, Robert J. Adams
The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection—study protocol for a two-stage randomised phase II trial
Ming Jie Lee, Simon Collins, Daphne Babalis, Nicholas Johnson, Emanuela Falaschetti, A. Toby Prevost, Ambreen Ashraf, Milaana Jacob, Tom Cole, Lisa Hurley, Matthew Pace, Ane Ogbe, Maryam Khan, Panagiota Zacharopoulou, Helen Brown, Euan Sutherland, Hanna Box, Julie Fox, Steven Deeks, Jill Horowitz, Michel C. Nussenzweig, Marina Caskey, John Frater, Sarah Fidler
A laparoscopic one anastomosis gastric bypass with wrapping versus nonwrapping fundus of the excluded part of the stomach to treat obese patients (FundoRingOAGB trial): study protocol for a randomized controlled trial
Oral Ospanov, Galymzhan Yeleuov, Alexandr Fursov, Bakhtiyar Yelembayev, Roman Fursov, Zhenis Sergazin, Adil Mustafin
Effect of m-health-based core stability exercise combined with self-compassion training for patients with non-specific chronic low back pain: study protocol for a randomized controlled trial
Zheng Fuming, Xiao Weihui, Yang Jiajia, Liu Shufeng, Zheng Yiyi, Liang Wenjian, Li Yan, Li Zhicheng, Zhang Siyun, Zou Yingmin, Wang Yuyin, Wang Chuhuai
Repurposing Probenecid for the Treatment of Heart Failure (Re-Prosper-HF): a study protocol for a randomized placebo-controlled clinical trial
Jack Rubinstein, Nathan Robbins, Karen Evans, Gabrielle Foster, Kevin Mcconeghy, Toluwalope Onadeko, Julie Bunke, Melanie Parent, Xi Luo, Jacob Joseph, Wen-Chih Wu
Evaluation of the effect of targeted Mass Drug Administration and Reactive Case Detection on malaria transmission and elimination in Eastern Hararghe zone, Oromia, Ethiopia: a cluster randomized control trial
Semira Abdelmenan, Hiwot Teka, Jimee Hwang, Samuel Girma, Sheleme Chibsa, Eric Tongren, Matthew Murphy, Mebrahatom Haile, Dereje Dillu, Jawar Kassim, Sinknesh Behaksra, Fitsum G. Tadesse, Joshua Yukich, Yemane Berhane, Alemayehu Worku, Joseph Keating, Ayele Zewde, Endalamaw Gadisa
The development of theory-informed participant-centred interventions to maximise participant retention in randomised controlled trials
Rumana Newlands, Eilidh Duncan, Shaun Treweek, Jim Elliott, Justin Presseau, Peter Bower, Graeme MacLennan, Margaret Ogden, Mary Wells, Miles D. Witham, Bridget Young, Katie Gillies
A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial
Xin Wu, Ling Qiu, Weihua Lou, Xipeng Wang, Tao Zhu, Yuyang Zhang, Weiguo Hu, Xiaohong Xue, Zhiling Zhu, Libing Xiang, Jiarui Li, Xuhong Fang, Shujun Gao, Hua Feng, Wenjing Diao, Hongwei Zhang, Ming Du, Yongrui Bai, Yanli Hou, Weili Yan, Hao Feng, Hailing Yu, Shurong Zhu, Yan Du, Hua Jiang
Safety, tolerability, and efficacy of monoclonal CD38 antibody felzartamab in late antibody-mediated renal allograft rejection: study protocol for a phase 2 trial
Katharina A. Mayer, Klemens Budde, Philip F. Halloran, Konstantin Doberer, Lionel Rostaing, Farsad Eskandary, Anna Christamentl, Markus Wahrmann, Heinz Regele, Sabine Schranz, Sarah Ely, Christa Firbas, Christian Schörgenhofer, Alexander Kainz, Alexandre Loupy, Stefan Härtle, Rainer Boxhammer, Bernd Jilma, Georg A. Böhmig
Design of the PERSPECTIVE study: PERsonalized SPEeCh Therapy for actIVE conversation in Parkinson’s disease (randomized controlled trial)
J. J. L. Maas, N. M. De Vries, B. R. Bloem, J. G. Kalf
The effect of dexmedetomidine on neuroprotection in pediatric cardiac surgery patients: study protocol for a prospective randomized controlled trial
Sang-Hwan Ji, Pyoyoon Kang, In-Sun Song, Young-Eun Jang, Ji-Hyun Lee, Jin-Tae Kim, Hee-Soo Kim, Eun-Hee Kim
Trial of transcutaneous electrical acupoint stimulation in laryngopharyngeal reflux disease: study protocol for a randomized controlled trial
Hailong Shen, Yanxun Han, Di Wu, Lihong Hu, Yunxia Ma, Feihu Wu, Ye Tao, Yehai Liu
Trial of Early Antiviral Therapies during Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19: a summary of the protocol and analysis plan for a decentralized randomized controlled trial
Alexander M. Kaizer, Jessica Wild, Christopher J. Lindsell, Todd W. Rice, Wesley H. Self, Samuel Brown, B. Taylor Thompson, Kimberly W. Hart, Clay Smith, Michael S. Pulia, Nathan I. Shapiro, Adit A. Ginde
Does closed-loop automated oxygen control reduce the duration of mechanical ventilation? A randomised controlled trial in ventilated preterm infants
Ourania Kaltsogianni, Theodore Dassios, Anne Greenough
Educational intervention for the prevention of occupational neck pain: protocol of randomized trial
Zohreh Moradi, Sedigheh Sadat Tavafian, Seyedeh Somayeh Kazemi
Effectiveness of an app-based intervention to reduce substance use, gambling, and digital media use in vocational school students: study protocol for a randomized controlled trial
Nicolas Arnaud, Johanna Weymann, Kirsten Lochbühler, Benjamin Pietsch, Monika Rossa, Ludwig Kraus, Rainer Thomasius, Reiner Hanewinkel, Matthis Morgenstern
Remote, real-time expert elicitation to determine the prior probability distribution for Bayesian sample size determination in international randomised controlled trials: Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone (BIPED) study
Jingxian Lan, Amy C. Plint, Stuart R. Dalziel, Terry P. Klassen, Martin Offringa, Anna Heath
Effect of listening to music on anxiety, pain, and cardiorespiratory parameters in cardiac surgery: study protocol for a randomized clinical trial
Érica Vieira de Andrade, Vanderlei José Haas, Maíla Fidalgo de Faria, Márcia Marques dos Santos Felix, Maria Beatriz Guimarães Ferreira, Elizabeth Barichello, Patricia da Silva Pires, Maria Helena Barbosa
Effect of multimodal intervention care on cachexia in patients with advanced cancer compared to conventional management (MIRACLE): an open-label, parallel, randomized, phase 2 trial
Chi Hoon Maeng, Bo-Hyung Kim, Jinmann Chon, Won Sub Kang, Kyounglan Kang, Mihye Woo, Il Ki Hong, Junhee Lee, Kil Yeon Lee
Collaborative community mental health and aged care services with peer support to prevent late-life depression: study protocol for a non-randomised controlled trial
Tianyin Liu, Dara Kiu Yi Leung, Shiyu Lu, Wai-Wai Kwok, Lesley Cai Yin Sze, Samson Shu Ki Tse, Siu Man Ng, Paul Wai Ching Wong, Vivian Wei Qun Lou, Jennifer Yee Man Tang, Daniel Fu Keung Wong, Wai Chi Chan, Ricky Yu Kwong Kwok, Terry Yat Sang Lum, Gloria Hoi Yan Wong
Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial
D. Ehrmann, V. Eichinger, I. Vesper, J. Kober, M. Kraus, V. Schäfer, N. Hermanns, B. Kulzer, S. Silbermann
Aerobic exercise and telomere length in patients with systolic heart failure: protocol study for a randomized controlled trial
Leandro T. Franzoni, Eduardo L. Garcia, Stephanie B. Motta, Mabel M. Ahner, Otávio A. Bertoletti, Marco A. L. Saffi, Anderson D. da Silveira, Alexandre A. Pereira, Adamastor H. Pereira, Luiz C. Danzmann, Ricardo Stein
PRObiotics and SYNbiotics to improve gut health and growth in infants in western Kenya (PROSYNK Trial): study protocol for a 4-arm, open-label, randomised, controlled trial
Mary Iwaret Otiti, Simon Kariuki, Duolao Wang, Lindsay J. Hall, Feiko O. Ter Kuile, Stephen Allen
Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus
Michael R. Backhouse, Daniel J. Parker, Stewart C. Morison, Jenny Anderson, Sarah Cockayne, Joy A. Adamson
Efficacy and safety of lumbrokinase plus aspirin versus aspirin alone for acute ischemic stroke (LUCENT): study protocol for a multicenter randomized controlled trial
Ying Chen, Yan Liu, Jingjing Zhang, Kehua Zhou, Xuecheng Zhang, Hengheng Dai, Baolin Yang, Hongcai Shang
The Positive Choices trial: update to study protocol for a phase-III RCT trial of a whole-school social-marketing intervention to promote sexual health and reduce health inequalities
Ruth Ponsford, Rebecca Meiksin, Elizabeth Allen, G. J. Melendez-Torres, Steve Morris, Catherine Mercer, Rona Campbell, Honor Young, Maria Lohan, Karin Coyle, Chris Bonell
The effectiveness of a media-based intervention promoting help-seeking for mental health difficulties by Australian men: study protocol for a randomised controlled trial
Angela Nicholas, Simone Scotti Requena, Maria Ftanou, Simon Rice, Justine Fletcher, Andrew Mackinnon, Zac Seidler, Long Khanh-Dao Le, Cathrine Mihalopoulos, Jane Pirkis
Effects of orthoptic therapy in children with intermittent exotropia after surgery: study protocol for a randomized controlled trial
Meiping Xu, Fuhao Zheng, Yiyi Peng, Chunxiao Wang, Jiangtao Lou, Huanyun Yu, Yuwen Wang, Xinping Yu
Advanced nursing practice and interprofessional dementia care (InDePendent): study protocol for a multi-center, cluster-randomized, controlled, interventional trial
Fabian Kleinke, Bernhard Michalowsky, Anika Rädke, Moritz Platen, Franka Mühlichen, Annelie Scharf, Wiebke Mohr, Peter Penndorf, Thomas Bahls, Neeltje van den Berg, Wolfgang Hoffmann
The impact of session-introducing mindfulness and relaxation interventions in individual psychotherapy for children and adolescents: a randomized controlled trial (MARS-CA)
Julia Kalmar, Ines Baumann, Elena Gruber, Eva Vonderlin, Hinrich Bents, Andreas B. Neubauer, Thomas Heidenreich, Johannes Mander
Bronchiectasis - Exercise as Therapy (BREATH): rationale and study protocol for a multi-center randomized controlled trial
Taryn Jones, Kerry-Ann F. O’Grady, Vikas Goyal, Ian B. Masters, Gabrielle McCallum, Christopher Drovandi, Thomas Lung, Emmah Baque, Denise S. K. Brookes, Caroline O. Terranova, Anne B. Chang, Stewart G. Trost
Single vs. double intracoronary injection of mesenchymal stromal cell after acute myocardial infarction: the study protocol from a randomized clinical trial: BOOSTER-TAHA7 trial
Armin Attar, Fatemeh Nouri, Arash Yazdanshenas, Kamran Hessami, Massoud Vosough, Alireza Abdi-Ardekani, Peyman Izadpanah, Mani Ramzi, Javad Kojouri, Gholamreza Pouladfar, Ahmad Monabati
The effect of a loading dose of meropenem on outcomes of patients with sepsis treated by continuous renal replacement: study protocol for a randomized controlled trial
Sui-Qing Ni, Wen-Bing Teng, Yong-Hong Fu, Wei Su, Zhi Yang, Jie Cai, Jin-Nuo Xu, Xiao-Ying Deng, Xiang-Fang Liu, Sheng-Nan Fu, Jun Zeng, Chen Zhang
Effects of double vs triple injection on block dynamics for ultrasound-guided intertruncal approach to the supraclavicular brachial plexus block in patients undergoing upper limb arteriovenous access surgery: study protocol for a double-blinded, randomized controlled trial
Quehua Luo, Huiying Liu, Longjiao Deng, Lidan Nong, Haifeng Li, Yujing Cai, Junyi Zheng, Haihua Shu, Weifeng Yao, Jianxing Zhang
Transcranial direct current stimulation to modulate brain reactivity to food cues in overweight and obese adults: study protocol for a randomized controlled trial with fMRI (NeuroStim-Obesity)
Peyman Ghobadi-Azbari, Nastaran Malmir, Meghedi Vartanian, Rasoul Mahdavifar-Khayati, Somaye Robatmili, Venus Hadian, Sara Derafsheh, Michael A. Nitsche, Masoud Nosratabadi, Ali Farhoudian, Hamed Ekhtiari
Patient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment
Madeleine Hinwood, Laura Wall, Danielle Lang, Zsolt J. Balogh, Angela Smith, Michelle Dowsey, Phillip Clarke, Peter Choong, Samantha Bunzli, Francesco Paolucci
Health belief model for empowering parental toothbrushing and sugar intake control in reducing early childhood caries among young children—study protocol for a cluster randomized controlled trial
Ketian Wang, Gillian Hiu Man Lee, Pei Liu, Xiaoli Gao, Samuel Yeung Shan Wong, May Chun Mei Wong
Within-subject effects of standardized prosthetic socket modifications on physical function and patient-reported outcomes
William Anderst, Goeran Fiedler, Kentaro Onishi, Gina McKernan, Tom Gale, Paige Paulus
Internet-based cognitive behavioral therapy for improving health-related quality of life in patients with endometriosis: study protocol for a randomized controlled trial
Kathrin Schubert, Johanna Lohse, Matthias Kalder, Volker Ziller, Cornelia Weise
Effect of novel training to normalize altered finger force direction post-stroke: study protocol for a double-blind randomized controlled trial
Na Jin Seo, Derek G. Kamper, Viswanathan Ramakrishnan, Jillian B. Harvey, Christian Finetto, Christian Schranz, Gabrielle Scronce, Kristen Coupland, Keith Howard, Jenna Blaschke, Adam Baker, Caitlyn Meinzer, Craig A. Velozo, Robert J. Adams
Stop of proton-pump inhibitor treatment in patients with liver cirrhosis (STOPPIT): study protocol for a prospective, multicentre, controlled, randomized, double-blind trial
Malte H. Wehmeyer, Thomas Horvatits, Anika Buchholz, Linda Krause, Sarah Walter, Antonia Zapf, Ansgar W. Lohse, Johannes Kluwe
A multicenter, open-label, randomized, proof-of-concept phase II clinical trial to assess the efficacy and safety of icatibant in patients infected with SARS-CoV-2 (COVID-19) and admitted to hospital units without invasive mechanical ventilation: study protocol (ICAT-COVID)
Pierre Malchair, Aurema Otero, Jordi Giol, Xavier Solanich, Thiago Carnaval, Alonso Fernández-Nistal, Ana Sánchez-Gabriel, Carmen Montoto, Ramon Lleonart, Sebastián Videla, Arnau Antoli, Marta Benjumeda, Tania Bernal, Laura Calatayud, Xavier Corbella, Anna Ferrer, Vanesa Garcia, Mercè Gasa, Carlota Gudiol, Pilar Hereu, Javier Jacob, Hector Jofre, Ferran Llopis, Leire Matellan, Natalia Pallarés, Raul Rigo, Gemma Rocamora, Freddy Rodríguez, Alexander Rombauts, José Carlos Ruibal, Joan Sabater, Carmen Serrano, Ana Suárez-Lledó, Cristian Tebé, Jesús Villoria, Alvaro Zarauza
A quasi-randomised controlled trial of online distribution of home-based hepatitis C self-testing for key populations in Malaysia: a study protocol
Sonjelle Shilton, Xiaohui Sem, Huan-Keat Chan, Han Yang Chung, Anu Karunanithy, Jessica Markby, Po-Lin Chan, Niklas Luhmann, Cheryl Johnson, Pamela Nabeta, Nazrila Hairizan Bt Nasir, Stefano Ongarello, Elena Ivanova Reipold, Muhammad Radzi Abu Hassan
Effect of RG (Coptis root and ginseng) formula in patients with type 2 diabetes mellitus: a study protocol for a randomized controlled and double-blinding trial
Li Jiang, Qiang Fu, Shidong Wang, Yu Chen, Jiayue Li, Yonghua Xiao, Ruixi Sun, Esther Aijia Shen, Junheng Wang, Yaofu Zhang, Zhuang Li, Jiangteng Liu, Xiaozhe Fu, Yuanyuan Liu, Yu Zhao, Guanxun Su, Weijun Huang, Jinxi Zhao
Increasing participation in habitual intellectual activities on modulating functional connectivity of default mode network among older adults at risk of dementia: study protocol of a randomized controlled trial
Rachel W. K. Yan, Charlotte P. C. Kwok, Jessie O. T. Kwok, Kaspar K. W. Lee, Hanna Lu, Winnie C. W. Chu, Timothy C. Y. Kwok, Linda C. W. Lam, Allen T. C. Lee
Use of the oral beta blocker bisoprolol to reduce the rate of exacerbation in people with chronic obstructive pulmonary disease (COPD): a randomised controlled trial (BICS)
Seonaidh Cotton, Graham Devereux, Hassan Abbas, Andrew Briggs, Karen Campbell, Rekha Chaudhuri, Gourab Choudhury, Dana Dawson, Anthony De Soyza, Shona Fielding, Simon Gompertz, John Haughney, Chim C. Lang, Amanda J. Lee, Graeme MacLennan, William MacNee, Kirsty McCormack, Nicola McMeekin, Nicholas L. Mills, Alyn Morice, John Norrie, Mark C. Petrie, David Price, Philip Short, Jorgen Vestbo, Paul Walker, Jadwiga Wedzicha, Andrew Wilson, Brian J. Lipworth
Improving glycemic control in patients with type 2 diabetes mellitus through a peer support instant messaging service intervention (DiabPeerS): study protocol for a randomized controlled trial
Elisabeth Höld, Johanna Grüblbauer, Martin Wiesholzer, Daniela Wewerka-Kreimel, Stefan Stieger, Werner Kuschei, Philip Kisser, Elisabeth Gützer, Ursula Hemetek, Astrid Ebner-Zarl, Jürgen Pripfl
INFLATE: a protocol for a randomised controlled trial comparing nasal balloon autoinflation to no nasal balloon autoinflation for otitis media with effusion in Aboriginal and Torres Strait Islander children
Robyn Walsh, Jennifer Reath, Hasantha Gunasekera, Amanda Leach, Kelvin Kong, Deborah Askew, Federico Girosi, Wendy Hu, Timothy Usherwood, Sanja Lujic, Geoffrey Spurling, Peter Morris, Chelsea Watego, Samantha Harkus, Cheryl Woodall, Claudette Tyson, Letitia Campbell, Sylvia Hussey, Penelope Abbott
Optimization of a new adaptive intervention using the SMART Design to increase COVID-19 testing among people at high risk in an urban community
Liliane Windsor, Ellen Benoit, Rogério M. Pinto, Jesus Sarol
An open-label clinical trial of oral transmucosal haloperidol and oral transmucosal olanzapine in the treatment of terminal delirium at home
Xiao-Juan Lyu, Adrian David Kan, Poh-Heng Chong, Keegan Lin, Yung-Hua Koh, Zhi-Zheng Yeo
Rapid chest compression effects on intracranial pressure in patients with acute cerebral injury
Ricardo Miguel Rodrigues-Gomes, Joan-Daniel Martí, Rosa Martínez Rolán, Miguel Gelabert-González
Does interactive ultrasound intervention relieve minor depressive symptoms and increase maternal attachment in pregnancy? A protocol for a randomized controlled trial
Henrika Pulliainen, Sari-Ahlqvist-Björkroth, Eeva Ekholm
Assessing the effectiveness of a LGBT cultural competency training for oncologists: study protocol for a randomized pragmatic trial
Julia Seay, Eryk N. Hernandez, Jaileene Pérez-Morales, Gwendolyn P. Quinn, Matthew B. Schabath
Comparison of the open kinetic chain and closed kinetic chain strengthening exercises on pain perception and lower limb biomechanics of patients with mild knee osteoarthritis: a randomized controlled trial protocol
Wei Hui Ng, Nazatul Izzati Jamaludin, Farhah Nadhirah Aiman Sahabuddin, Shaifuzain Ab Rahman, Amran Ahmed Shokri, Shazlin Shaharudin
Effect of an artificial intelligence-assisted tool on non-valvular atrial fibrillation anticoagulation management in primary care: protocol for a cluster randomized controlled trial
Xueying Ru, Lan Zhu, Yunhui Ma, Tianhao Wang, Zhigang Pan
Effect of Baihu and Guizhi decoction in acute gouty arthritis: study protocol for a randomized controlled trial
Yikun He, Chaoran Dai, Jiaying Shen, Qianwen Chen, Jiandong Gao, Xin Pan, Jing Gan
PolyMyalgia Rheumatica treatment with Methotrexate in Optimal Dose in an Early disease phase (PMR MODE): study protocol for a multicenter double-blind placebo controlled trial
Diane E. Marsman, Thomas E. Bolhuis, Nathan den Broeder, Alfons A. den Broeder, Aatke van der Maas
Correction: Cytokine adsorption in patients with acute-on-chronic liver failure (CYTOHEP)—a single center, open-label, three-arm, randomized, controlled intervention trial
Asieb Sekandarzad, Enya Weber, Eric Peter Prager, Erika Graf, Dominik Bettinger, Tobias Wengenmayer, Alexander Supady
Correction: Study protocol for a cluster randomised trial of sterile glove and instrument change at the time of wound closure to reduce surgical site infection in low- and middle-income countries (CHEETAH)
Adesoji O Ademuyiwa, Adewale O. Adisa, Aneel Bhangu, Peter Brocklehurst, Sohini Chakrabortee, Dhruva Ghosh, James Glasbey, Parvez D Haque, Pollyanna Hardy, Ewen Harrison, JC Allen Ingabire, Lawani Ismail, Bryar Kadir, Rachel Lillywhite, Laura Magill, Antonio Ramos de la Medina, Rachel Moore, Mark Monahan, Dion Morton, Dmitri Nepogodiev, Faustin Ntirenganya, Omar Omar, Thomas Pinkney, Donna Smith, Stephen Tabiri, Neil Winkles
Correction: Sterile water injections for relief of labour pain (the SATURN trial): study protocol for a randomised controlled trial
Nigel Lee, Yu Gao, Lena B. Mårtensson, Leonie Callaway, Belinda Barnett, Sue Kildea
Efficacy and safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening (MyMiROPS): study protocol for a non-inferiority crossover randomized controlled trial
Aikaterini K. Seliniotaki, Anna-Bettina Haidich, Maria Lithoxopoulou, Helen Gika, Eleftheria Boutou, Christina Virgiliou, Martha Nikolaidou, Aristides Dokoumetzidis, Nikolaos Raikos, Elisavet Diamanti, Nikolaos Ziakas, Asimina Mataftsi
Efficacy of leg swing versus quadriceps strengthening exercise among patients with knee osteoarthritis: study protocol for a randomized controlled trial
Ruiyang Li, Pingping Sun, Yu Zhan, Xuetao Xie, Weibing Yan, Congfeng Luo
Study of effect of nimodipine and acetaminophen on postictal symptoms in depressed patients after electroconvulsive therapy (SYNAPSE)
Joey P. A. J. Verdijk, Julia C. M. Pottkämper, Esmée Verwijk, Guido A. van Wingen, Michel J. A. M. van Putten, Jeannette Hofmeijer, Jeroen A. van Waarde
Protocol for a cluster randomised controlled trial of LPG cookstoves compared to usual cooking practices to reduce perinatal mortality and morbidity in rural Bangladesh called Poriborton: the CHANge trial
Camille Raynes-Greenow, Ashraful Alam, Sk Masum Billah, Sajia Islam, Kingsley Agho, S. M. Rokonuzzaman, Jonathan Thornburg, Shams El Arifeen, Atique Iqbal Chowdhury, Bin Jalaludin, Nick Goodwin, Alison Hayes, Tanvir Huda, Md. Jahiduj Jaman, Jasmin Khan, Michael J. Dibley
WalkingPad protocol: a randomized clinical trial of behavioral and motivational intervention added to smartphone-enabled supervised home-based exercise in patients with peripheral arterial disease and intermittent claudication
Ivone Silva, Susana Pedras, Rafaela Oliveira, Carlos Veiga, Hugo Paredes
Family systemic psychosocial support for at-risk adolescents in Lebanon: study protocol for a multi-site randomised controlled trial
Felicity L. Brown, Tania Bosqui, Joseph Elias, Sally Farah, Anas Mayya, Diana Abo Nakkoul, Bryony Walsh, Sarah Chreif, Ahmad Einein, Bassel Meksassi, Roula Abi Saad, Hady Naal, Maliki E. Ghossainy, Michael Donnelly, Theresa S. Betancourt, Alan Carr, Eve Puffer, Rabih El Chammay, Mark J. D. Jordans
Planning a method for covariate adjustment in individually randomised trials: a practical guide
Tim P. Morris, A. Sarah Walker, Elizabeth J. Williamson, Ian R. White
Effectiveness of Tai Chi Yunshou motor imagery training for hemiplegic upper extremity motor function in poststroke patients: study protocol for a randomized clinical trial
Lin Hong Jiang, Li Juan Zhao, Yang Liu, Hong Zhang, Si Cong Zhang, Wei Qin Cong, Rui Qi
Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary
Kinga Amália Sándor-Bajusz, Andrea Kraut, Odgerel Baasan, Gergely Márovics, Károly Berényi, Szimonetta Lohner
Aspirin to target arterial events in chronic kidney disease (ATTACK): study protocol for a multicentre, prospective, randomised, open-label, blinded endpoint, parallel group trial of low-dose aspirin vs. standard care for the primary prevention of cardiovascular disease in people with chronic kidney disease
Hugh Gallagher, Jennifer Dumbleton, Tom Maishman, Amy Whitehead, Michael V. Moore, Ahmet Fuat, David Fitzmaurice, Robert A. Henderson, Joanne Lord, Kathryn E. Griffith, Paul Stevens, Maarten W. Taal, Diane Stevenson, Simon D. Fraser, Mark Lown, Christopher J. Hawkey, Paul J. Roderick
PROmotion of COvid-19 VA(X)ccination in the Emergency Department—PROCOVAXED: study protocol for a cluster randomized controlled trial
Robert M. Rodriguez, Kelli O’Laughlin, Stephanie A. Eucker, Anna Marie Chang, Kristin L. Rising, Graham Nichol, Alena Pauley, Hemal Kanzaria, Alexzandra T. Gentsch, Cindy Li, Herbie Duber, Jonathan Butler, Vidya Eswaran, Dave Glidden
STRONG for Surgery & Strong for Life — against all odds: intensive prehabilitation including smoking, nutrition, alcohol and physical activity for risk reduction in cancer surgery — a protocol for an RCT with nested interview study (STRONG-Cancer)
Hanne Tønnesen, Line Noes Lydom, Ulla Nordström Joensen, Ingrid Egerod, Helle Pappot, Susanne Vahr Lauridsen
Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated balloon or standard uncoated balloon angioplasty: a structured protocol summary of the “SirPAD” randomized controlled trial
Stefano Barco, Tim Sebastian, Davide Voci, Rolf Peter Engelberger, Alexandru Grigorean, Erik Holy, Claudia Leeger, Mario Münger, Daniel Périard, Eliane Probst, Rebecca Spescha, Ulrike Held, Nils Kucher
Tolvaptan versus fluid restriction in acutely hospitalised patients with moderate-profound hyponatraemia (TVFR-HypoNa): design and implementation of an open-label randomised trial
Annabelle M. Warren, Mathis Grossmann, Rudolf Hoermann, Jeffrey D. Zajac, Nicholas Russell
Correction to: SPIKE-1: A Randomised Phase II/III trial in a community setting, assessing use of camostat in reducing the clinical progression of COVID-19 by blocking SARS-CoV-2 Spike protein-initiated membrane fusion
Sarah Halford, Susan Wan, Ilaria Dragoni, Julie Silvester, Bobojon Nazarov, Daniel Anthony, Suzie Anthony, Emma Ladds, John Norrie, Kevin Dhaliwal
Implementation and evaluation of a large-scale postpartum family planning program in Rwanda: study protocol for a clinic-randomized controlled trial
Kristin M. Wall, Rosine Ingabire, Amelia Mazzei, Claudine Umuhoza, Rachel Parker, Amanda Tichacek, Azhar Nizam, Jessica M. Sales, Lisa B. Haddad, Phaedra Corso, Susan Allen, Julien Nyombayire, Etienne Karita
Study on the efficacy and safety of the combination of Shi’s manual therapy and percutaneous endoscopic lumbar diskectomy for lumbar disc herniation with radiculopathy: study protocol for a multicenter randomized controlled trial
Huihao Wang, Weian Yuan, Zhongxiang Yu, Xiang Wang, Xinxin Zhao, Zhen Deng, Guangyue Yang, Weinan Chen, Zhibi Shen, Hongsheng Zhan
Efficacy and safety of scopolamine compared to placebo in individuals with bipolar disorder who are experiencing a depressive episode (SCOPE-BD): study protocol for a randomised double-blind placebo-controlled trial
Cerena Miravalles, Ruán Kane, Eimear McMahon, Colm McDonald, Dara M. Cannon, Brian Hallahan
Effect of antisecretory factor, given as a food supplement to adult patients with severe traumatic brain injury (SASAT): protocol for an exploratory randomized double blind placebo-controlled trial
David Cederberg, Bradley M. Harrington, Adriaan Johannes Vlok, Peter Siesjö
M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID
Valérie Martel-Laferrière, Daniel J. Feaster, Lisa R. Metsch, Bruce R. Schackman, Christine Loignon, Bohdan Nosyk, Hansel Tookes, Czarina N. Behrends, Nelson Arruda, Oluleye Adigun, Marie-Eve Goyer, Michael A. Kolber, Jean-Francois Mary, Allan E. Rodriguez, Iveth G. Yanez, Yue Pan, Rania Khemiri, Lauren Gooden, Aïssata Sako, Julie Bruneau
An adaptive design to screen, treat, and retain people with opioid use disorders who use methamphetamine in methadone clinics (STAR-OM): study protocol of a clinical trial
Le Minh Giang, Nguyen Thu Trang, Nguyen Bich Diep, Dao Thi Dieu Thuy, Dinh Thanh Thuy, Han Dinh Hoe, Hoang Thi Hai Van, Thai Thanh Truc, Hoa H. Nguyen, Nguyen Ly Lai, Pham Thi Dan Linh, Vu Thi Tuong Vi, Cathy J. Reback, Arleen Leibowitz, Li Li, Chunqing Lin, Michael Li, Do Van Dung, Steve Shoptaw
Quality problems of clinical trials in China: evidence from quality related studies
Jin Fan, Xiaobo Liu, Yuxi Li, Haisha Xia, Rong Yang, Juan Li, Yonggang Zhang
Efficacy of thunder-fire moxibustion in treating ankylosing spondylitis of kidney deficiency and governor meridian cold and its influence on TNF-α and RANKL: study protocol for a prospective, nonblinded, single-center, randomized controlled trial
Yang Liu, Pei Wang, Yan Yan Sun, Jing Qu, Min Li
Effects of Jianpi Lishi Jiedu granules on colorectal adenoma patients after endoscopic treatment: study protocol for a randomized, double-blinded, placebo-controlled clinical trial
Hao Wu, Yuzhen Huang, Lu Yang, Kunhan Su, Shuo Tian, Xin Chen, Siyu Li, Wanli Liu
The effect of a social network-based cognitive behavioral therapy intervention on the severity of premenstrual syndrome symptoms: a protocol of a randomized clinical trial study
Zainab Alimoradi, Somayeh Rajabalipour, Khaled Rahmani, Amir H. Pakpour
Trauma-focused treatments for refugee children: study protocol for a randomized controlled trial of the effectiveness of KIDNET versus EMDR therapy versus a waitlist control group (KIEM)
Merel E. Velu, Irene Martens, Mona Shahab, Carlijn de Roos, Ruud A. Jongedijk, Michaela Schok, T. Mooren
Effect of Automated Closed-loop ventilation versus convenTional VEntilation on duration and quality of ventilation in critically ill patients (ACTiVE) – study protocol of a randomized clinical trial
Michela Botta, Anissa M. Tsonas, Jante S. Sinnige, Ashley J. R. De Bie, Alexander J. G. H. Bindels, Lorenzo Ball, Denise Battaglini, Iole Brunetti, Laura A. Buiteman–Kruizinga, Pim L. J. van der Heiden, Evert de Jonge, Francesco Mojoli, Chiara Robba, Abraham Schoe, Frederique Paulus, Paolo Pelosi, Ary Serpa Neto, Janneke Horn, Marcus J. Schultz, Michela Botta, Anissa M. Tsonas, Jante S. Sinnige, Ashley J. R. De Bie, Alexander J. G. H. Bindels, Lorenzo Ball, Denise Battaglini, Iole Brunetti, Laura A. Buiteman–Kruizinga, Pim L. J. van der Heiden, Evert de Jonge, Francesco Mojoli, Chiara Robba, Abraham Schoe, Frederique Paulus, Paolo Pelosi, Ary Serpa Neto, Janneke Horn, Marcus J. Schultz
Health effects of utilising hospital contacts to provide measles vaccination to children 9–59 months—a randomised controlled trial in Guinea-Bissau
Ane B. Fisker, Justiniano S. D. Martins, Andreas M. Jensen, Cesario Martins, Peter Aaby, Sanne M. Thysen
Developing a theoretically informed education programme within the context of a complex implementation strategy in UK primary care: an exemplar from the IMP2ART trial
Kirstie McClatchey, Viv Marsh, Liz Steed, Steve Holmes, Stephanie J. C. Taylor, Sharon Wiener-Ogilvie, Julia Neal, Rhian Last, Ann Saxon, Hilary Pinnock
Correction to: Effect of Tai Chi combined with Kinesio taping on posture control of football players with FAI: protocol for a randomized controlled trial
Youhua Li, Xingyue Liu, Xiwen Luo, Chunjie Guo
Salbutamol for analgesia in renal colic: study protocol for a prospective, randomised, placebo-controlled phase II trial (SARC)
Graham Johnson, Andrew Tabner, Apostolos Fakis, Rachelle Sherman, Victoria Chester, Elizabeth Bedford, Richard Jackson, Hari Ratan, Suzanne Mason
Effect of GOAL-Directed ANalgesia using ANI (Analgesia/Nociception Index) during general anesthesia on immediate postoperative pain and intraoperative hemodynamics in adult patients (GOALDAN study): a study protocol for randomized, controlled, multicenter trial
Adrien Michalot, Jean-Étienne Bazin, Philippe Richebé, Bernard Allaouchiche, Emmanuel Boselli
The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments
Jason S. Haukoos, Sarah E. Rowan, James W. Galbraith, Richard E. Rothman, Yu-Hsiang Hsieh, Emily Hopkins, Rachel A. Houk, Matthew F. Toerper, Kevin F. Kamis, Jake R. Morgan, Benjamin P. Linas, Alia A. Al-Tayyib, Edward M. Gardner, Michael S. Lyons, Allison L. Sabel, Douglas A. E. White, David L. Wyles, Amy Adler, Musheng Alishahi, Gideon D. Avornu, Alexis Becerra, Erika Becerra-Ashby, Samantha Bot, Alexander J. Boyle, Annetta M. Bracey, Michael Breyer, Claudia Camacho, Alicia Cupelo, Gaby Dashler, Pamela Doyle, Amy Eicher, Heather Gardner, Carrie Anne de Gruiter, Stephanie Gravitz, Sophia Henry, David Higgins, Trevor Hill, Nyah Johnson, Alex Kile, Janet Liebl, Carolynn Lyle, Barbara Maliszewski, Kendall Maliszewski, Robert McGoey, Catherine McKenzie, Matthew S. Minturn, Deanna Myer, Kendra Neumann, Cole Ossian, Rebekah K. Peacock, Danielle Perez, Tannishtha Pramanick, Erin P. Ricketts, Benji Riggan, Sherry Riser, Genie Roosevelt, Mustapha Saheed, Bradley Shy, Scott Simpson, Gil Trest, Madison Unsworth, Laura Waltrous, Brooke Watson
Mobile Subthreshold Exercise Program (MSTEP) for concussion: study protocol for a randomized controlled trial
Sara P. D. Chrisman, Beth J. Bollinger, Jason A. Mendoza, Tonya M. Palermo, Chuan Zhou, M. Alison Brooks, Frederick P. Rivara
Clinical implementation of an algorithm for predicting exacerbations in patients with COPD in telemonitoring: a study protocol for a single-blinded randomized controlled trial
Pernille Heyckendorff Secher, Stine Hangaard, Thomas Kronborg, Lisa Korsbakke Emtekær Hæsum, Flemming Witt Udsen, Ole Hejlesen, Clara Bender
Clinical trial management: a profession in crisis?
E. J. Mitchell, K. Goodman, N. Wakefield, C. Cochran, S. Cockayne, S. Connolly, R. Desai, S. Hartley, S. A. Lawton, K. Oatey, S. Rhodes, J. S. Savage, J. Taylor, N. F. J. Youssouf, Eleanor Mitchell, Kirsteen Goodman, Natalie Wakefield, Claire Cochran, Sarah Cockayne, Simon Connolly, Riti Desai, Lucy Fletcher, Suzanne Hartley, Sarah Lawton, Ryonfa Lee, Katherine Oatey, Shelley Rhodes, Joshua Savage, Jodi Taylor, Nabila Youssouf
Measuring aniseikonia and investigating neuroplasticity and image factors in amblyopia (MAGNIFY): study protocol for a randomised clinical trial
Jayshree South, Tina Gao, Melinda Calderwood, Jason Turuwhenua, Paul Roberts, Arier Lee, Andrew Collins, Joanna Black
The SPIRIT Checklist—lessons from the experience of SPIRIT protocol editors
Riaz Qureshi, Alexander Gough, Kirsty Loudon
The efficacy of Narrative Exposure Therapy for Children (KIDNET) as a treatment for traumatized young refugees versus treatment as usual: update to the study protocol for the multi-center randomized controlled trial YOURTREAT
Jasmin Wittmann, Melissa Groß, Claudia Catani, Telja Schmidt, Sina Neldner, Sarah Wilker, Theodor May, Verena Ertl, Rita Rosner, Areej Zindler, Michael Odenwald, Frank Neuner
Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY disease (CLARITY): statistical analysis plan for a randomised controlled Bayesian adaptive sample size trial
J. M. McGree, C. Hockham, S. Kotwal, A. Wilcox, A. Bassi, C. Pollock, L. M. Burrell, T. Snelling, V. Jha, M. Jardine, M. Jones
Assessing gait, balance, and muscle strength among breast cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN): study protocol for a randomized controlled clinical trial
Patricia Teran-Wodzinski, Douglas Haladay, Tuan Vu, Ming Ji, Jillian Coury, Alana Adams, Lauren Schwab, Constance Visovsky
Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial
Binyu Yu, Philippa Jemma Hazlewood, Xuan Yin, Shanshan Li, Hongyu Yue, Kun Xu, Shifen Xu, Yiqun Mi
Effectiveness of modified Buzhong Yiqi decoction in treating myasthenia gravis: study protocol for a series of N-of-1 trials
Senhui Weng, Jinghao Li, Benshu Chen, Long He, Zhuotai Zhong, Linwen Huang, Shijing Zhang, Fengbin Liu, Qilong Jiang
Development and evaluation of a package to improve hypertension control in Nigeria [DEPIHCON]: a cluster-randomized controlled trial
IkeOluwapo O. Ajayi, Oyediran E. Oyewole, Okechukwu S. Ogah, Joshua O. Akinyemi, Mobolaji M. Salawu, Eniola A. Bamgboye, Taiwo Obembe, Morenikeji Olawuwo, Mahmoud Umar Sani
Optimization of measurement-based care (OMBC) for depression based on all-round and continuous assessment: rationale and protocol for a multicenter randomized control clinical trial
Jingjing Zhou, Xiao Wang, Jian Yang, Xuequan Zhu, Le Xiao, Lei Feng, Gang Wang
The effect of (-)-epigallocatechin gallate as an adjunct to non-surgical periodontal treatment: a randomized clinical trial
Jiajun Zeng, Yanfeng Wang, Qiao Yuan, Qingxian Luan
A behavior change wheel-based interactive pictorial health education program for hypertensive patients with low blood pressure health literacy: study protocol for a randomized controlled trial
Wei Gan, Qinghua Zhang, Dan Yang, Jinyu Yin, Yujie Wang, Li Song, Ting Chen, Huan Qi
A cost-effectiveness and value of information analysis to inform future research of tranexamic acid for older adults experiencing mild traumatic brain injury
Jack Williams, Katharine Ker, Ian Roberts, Haleema Shakur-Still, Alec Miners
Individualised computerised cognitive training for community-dwelling people with mild cognitive impairment: study protocol of a completely virtual, randomised, controlled trial
Stephanie Book, Michael Jank, Anna Pendergrass, Elmar Graessel
Efficacy and safety of Tanreqing oral liquid in treatment of acute bronchitis: study protocol for a randomized controlled trial
Guilan Cheng, Bin She, Bing Mao, Hongli Jiang
Operational complexity versus design efficiency: challenges of implementing a phase IIa multiple parallel cohort targeted treatment platform trial in advanced breast cancer
Claire Snowdon, Sarah Kernaghan, Laura Moretti, Nicholas C. Turner, Alistair Ring, Katie Wilkinson, Sue Martin, Stephanie Foster, Lucy S. Kilburn, Judith M. Bliss
Comparison of the effects of neostigmine and sugammadex on postoperative residual curarization and postoperative pulmonary complications by means of diaphragm and lung ultrasonography: a study protocol for prospective double-blind randomized controlled trial
Yu-guan Zhang, Ying Chen, Yue-Lun Zhang, Jie Yi
The European & Developing Countries Clinical Trials Partnership (EDCTP) Knowledge Hub: developing an open platform for facilitating high-quality clinical research
Samuel Driver, Shan Gray, Welile Sikhondze, Ken Awuonda, Helena Wilcox, Alexis Segrt, Lara Pandya, Johanna Roth, Michael Makanga, Trudie Lang
Rehabilitation for life: the effect on physical function of rehabilitation and care in older adults after hip fracture—study protocol for a cluster-randomised stepped-wedge trial
Jonas Ammundsen Ipsen, Lars T. Pedersen, Bjarke Viberg, Birgitte Nørgaard, Charlotte Suetta, Inge H. Bruun
Resources for Enhancing Alzheimer’s Caregiver Health in Vietnam (REACH VN): study protocol for a cluster randomized controlled trial to test the efficacy of a family dementia caregiver intervention in Vietnam
Duyen Tran, Huong Nguyen, Thang Pham, Anh T. Nguyen, Hung T. Nguyen, Ngoc B. Nguyen, Bien H. Nguyen, Danielle Harvey, Laura Gitlin, Ladson Hinton
High-flow nasal cannula versus standard low-flow nasal cannula during deep sedation in patients undergoing radiofrequency atrial fibrillation catheter ablation: a single-centre randomised controlled trial
Marloes C. Homberg, Esther A. Bouman, Dominik Linz, Sander M. J. van Kuijk, Bert A. Joosten, Wolfgang F. Buhre
The efficacy and safety of Longmu Tang granule for the treatment of atopic dermatitis: study protocol for a single-centred, double-blinded, randomised, placebo-controlled trial
Ya-qin Li, Tao-tao Shen, Qing-ying Wang, Meng-xi Ma, Feng-yan Tian, Yuan-yao She, Yi-cheng Tao, Jing-jing Wang, Hui-yan Chi, Na Lang, Jian-xun Ren
Facilitating relaxation and stress reduction in healthy participants through a virtual reality intervention: study protocol for a non-inferiority randomized controlled trial
Miriam Kampa, Johannes Finke, Tobias Stalder, Leandra Bucher, Holger Klapperich, Fabian Mertl, Christian Zimmer, Christian Geiger, Marc Hassenzahl, Tim Klucken
Correction: Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus
Michael R. Backhouse, Daniel J. Parker, Stewart C. Morrison, Jenny Anderson, Sarah Cockayne, Joy A. Adamson
Prevention of medication overuse and medication overuse headache in patients with migraine: a randomized, controlled, parallel, allocation-blinded, multicenter, prospective trial using a mobile software application
Hans-Christoph Diener, Stephen Donoghue, Charly Gaul, Dagny Holle-Lee, Karl-Heinz Jöckel, Alec Mian, Bernadette Schröder, Tobias Kühl
Elucidating treatment targets and mediators within a confirmatory efficacy trial: study protocol for a randomized controlled trial of cognitive-behavioral therapy vs. light therapy for winter depression
Kelly J. Rohan, Peter L. Franzen, Kathryn A. Roeckelin, Greg J. Siegle, David J. Kolko, Teodor T. Postolache, Pamela M. Vacek
The effectiveness and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma patients with uncontrolled torso haemorrhage: study protocol for a randomised clinical trial (the UK-REBOA trial)
Jan O. Jansen, Claire Cochran, Dwayne Boyers, Katie Gillies, Robbie Lendrum, Sam Sadek, Fiona Lecky, Graeme MacLennan, Marion K. Campbell, Jan O. Jansen, Marion K. Campbell, Chris Moran, Karim Brohi, Fiona Lecky, Robbie Lendrum, Graeme MacLennan, Jonathan J. Morrison, Nigel Tai, Tim Harris, John Norrie, Dwayne Boyers, Alan Paterson, Nick Welch
Success and failure factors of patient recruitment for industry-sponsored clinical trials and the role of the electronic health records—a qualitative interview study in the Nordic countries
Niina Laaksonen, Mia Bengtström, Anna Axelin, Juuso Blomster, Mika Scheinin, Risto Huupponen
Impact of El-Poems study: the e-learning for postural education in music students: a randomized controlled trial protocol
Zahra Akbari-Chehrehbargh, Sedigheh Sadat Tavafian
E-Consent—a guide to maintain recruitment in clinical trials during the COVID-19 pandemic
Ricardo Almeida-Magana, Hanna Maroof, Jack Grierson, Rosie Clow, Eoin Dinneen, Tarek Al-Hammouri, Nicola Muirhead, Chris Brew-Graves, John Kelly, Greg Shaw
Efficacy and safety of Tibetan medicine Qingpeng ointment for acute gouty arthritis: protocol for a multi-center, randomized, double-blind, placebo-controlled trial
Ya-xi Shang, Xia Dong, Zhi-min Xie, Xiao-peng Li, Xin-chang Wang, Ji-yong Huang, Shu-feng Wei, Yuan Liu, Jian-ping Liu
ACL Surgery Necessity in Non-Acute Patients (ACL SNNAP): a statistical analysis plan for a randomised controlled trial
Jamie R. Stokes, David J. Beard, Loretta Davies, Beverly A. Shirkey, Andrew Price, Jonathan A. Cook, Karen Barker, Andrew Carr, Jonathan Cook, Loretta Davies, Fares Haddad, William Jackson, Sallie Lamb, Jose Leal, Paul Monk, Sean O’Leary, Andrew Price, Chris Wilson
Securing jugular central venous access devices with dressings fixed to a liquid adhesive in an intensive care unit population: a randomised controlled trial
India Pearse, Amanda Corley, Emily N. Larsen, Claire M. Rickard, Robert S. Ware, Jill Campbell, Fiona Coyer, Evan Alexandrou, Catherine O’Brien, Nicole Marsh
The effect of delivery ball and warm shower on the childbirth experience of nulliparous women: a randomized controlled clinical trial
Parvaneh Sharifipour, Masoomeh Kheirkhah, Mojgan Rajati, Hamid Haghani
Internet of things-based home noninvasive ventilation in COPD patients with hypercapnic chronic respiratory failure: study protocol for a randomized controlled trial
Weipeng Jiang, Yuanlin Song
How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme
Alison Powell, Sarah Hoare, Rakesh Modi, Kate Williams, Andrew Dymond, Cheryl Chapman, Simon Griffin, Jonathan Mant, Jenni Burt
Comparison of BARD®LIFESTREAM™ covered balloon-expandable stent versus GORE® VIABAHN™ covered self-expandable stent in treatment of aortoiliac obstructive disease: study protocol for a prospective randomized controlled trial (NEONATAL trial)
Yuhan Qi, Jiarong Wang, Jichun Zhao, Bing Huang, Fei Xiong, Xiaojiong Du, Xiyang Chen, Qiang Guo, Tiehao Wang, Ding Yuan
How much is the lack of retention evidence costing trial teams in Ireland and the UK?
Ellen Murphy, Frances Shiely, Shaun Treweek
Self-guided virtual reality therapy for social anxiety disorder: a study protocol for a randomized controlled trial
Anne Sophie Hildebrand, Kati Roesmann, Jari Planert, Alla Machulska, Esra Otto, Tim Klucken
Efficacy of contralaterally controlled functional electrical stimulation compared to cyclic neuromuscular electrical stimulation and task-oriented training for recovery of hand function after stroke: study protocol for a multi-site randomized controlled trial
Jayme S. Knutson, Amy S. Friedl, Kristine M. Hansen, Mary Y. Harley, A. M. Barrett, Preeti Raghavan, Ela B. Plow, Douglas D. Gunzler, John Chae
Tuberculosis screening improves preventive therapy uptake (TB SCRIPT) trial among people living with HIV in Uganda: a study protocol of an individual randomized controlled trial
Fred C. Semitala, Lelia H. Chaisson, David W. Dowdy, Derek T. Armstrong, Bishop Opira, Kyomugisha Aman, Moses Kamya, Patrick P. J. Phillips, Christina Yoon
Behavioural optimisation to address trial conduct challenges: case study in the UK-REBOA trial
Louisa Lawrie, Eilidh M. Duncan, Jan O. Jansen, Marion K. Campbell, Dan Brunsdon, Zoë Skea, Taylor Coffey, Claire Cochran, Katie Gillies
Brief Educational Video plus Telecare to Enhance Recovery for Older Emergency Department Patients with Acute Musculoskeletal Pain: an update to the study protocol for a randomized controlled trial
Karen Hurka-Richardson, Timothy F. Platts-Mills, Samuel A. McLean, Morris Weinberger, Sally C. Stearns, Montika Bush, Eugenia Quackenbush, Srihari Chari, Aileen Aylward, Kurt Kroenke, Robert D. Kerns, Mark A. Weaver, Francis J. Keefe, David Berkoff, Michelle L. Meyer
Repair of acute respiratory distress syndrome by stromal cell administration (REALIST): a structured study protocol for an open-label dose-escalation phase 1 trial followed by a randomised, triple-blind, allocation concealed, placebo-controlled phase 2 trial
Ellen Gorman, Manu Shankar-Hari, Phil Hopkins, William S. Tunnicliffe, Gavin D. Perkins, Jonathan Silversides, Peter McGuigan, Colette Jackson, Roisin Boyle, Jamie McFerran, Cliona McDowell, Christina Campbell, Margaret McFarland, Jon Smythe, Jacqui Thompson, Barry Williams, Gerard Curley, John G. Laffey, Mike Clarke, Daniel F. McAuley, Cecilia O’Kane
The Cancer Financial Experience (CAFÉ) study: randomized controlled trial of a financial navigation intervention to address cancer-related financial hardship
Nora B. Henrikson, Melissa L. Anderson, John Dickerson, John J. Ewing, Robin Garcia, Erin Keast, Deborah A. King, Cara Lewis, Blake Locher, Carmit McMullen, Consuelo M. Norris, Amanda F. Petrik, Arvind Ramaprasan, Jennifer S. Rivelli, Jennifer L. Schneider, Lisa Shulman, Leah Tuzzio, Matthew P. Banegas
Patient-individualized resection planning in liver surgery using 3D print and virtual reality (i-LiVR)—a study protocol for a prospective randomized controlled trial
Tobias Huber, Laura Isabel Hanke, Christian Boedecker, Lukas Vradelis, Janine Baumgart, Stefan Heinrich, Fabian Bartsch, Jens Mittler, Alicia Schulze, Christian Hansen, Florentine Hüttl, Hauke Lang
Analgesic effect of auricular point acupressure for acute pain in patients with dementia: study protocol for a randomized controlled trial
Xiao-Min Chai, Hong-Yan Shi, Jun-Jun Zhang, Lei Wang, Hai-Xiang Gao, Ya-Liang Dai, Lu-Lu Gao, Jian-Qiang Yu, Yu-Xiang Li, Carol Chunfeng Wang
Reduced anticoagulation targets in extracorporeal life support (RATE): study protocol for a randomized controlled trial
Olivier van Minnen, Annemieke Oude Lansink-Hartgring, Bas van den Boogaard, Judith van den Brule, Pierre Bulpa, Jeroen J. H. Bunge, Thijs S. R. Delnoij, Carlos V. Elzo Kraemer, Marijn Kuijpers, Bernard Lambermont, Jacinta J. Maas, Jesse de Metz, Isabelle Michaux, Ineke van de Pol, Marcel van de Poll, S. Jorinde Raasveld, Matthias Raes, Dinis dos Reis Miranda, Erik Scholten, Olivier Simonet, Fabio S. Taccone, Frederic Vallot, Alexander P. J. Vlaar, Walter M. van den Bergh
Study protocol to test the efficacy of self-administration of dexmedetomidine sedative therapy on anxiety, delirium, and ventilator days in critically ill mechanically ventilated patients: an open-label randomized clinical trial
Linda L. Chlan, Craig R. Weinert, Mary Fran Tracy, Debra J. Skaar, Ognjen Gajic, Jessica Ask, Jay Mandrekar
Dalbavancin as an option for treatment of S. aureus bacteremia (DOTS): study protocol for a phase 2b, multicenter, randomized, open-label clinical trial
Nicholas A. Turner, Smitha Zaharoff, Heather King, Scott Evans, Toshimitsu Hamasaki, Thomas Lodise, Varduhi Ghazaryan, Tatiana Beresnev, Todd Riccobene, Rinal Patel, Sarah B. Doernberg, Urania Rappo, Vance G. Fowler Jr, Thomas L. Holland
Traditional acupuncture and laser acupuncture in chronic nonspecific neck pain: study protocol for a randomized controlled trial
Rafaela Peron, Érika Patrícia Rampazo, Richard Eloin Liebano
Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences
Kate Escritt, Mala Mann, Annmarie Nelson, Emily Harrop
A cluster-randomized trial of a complex intervention to encourage deprescribing antidepressants in nursing home residents with dementia: a study protocol
Pernille Hølmkjær, Anne Holm, Gritt Overbeck, Maarten Pieter Rozing
Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders’ attitudes
Aran Fitzpatrick, Fiona Wood, Victoria Shepherd
Effectiveness of a clinical decision support system for hypertension management in primary care: study protocol for a pragmatic cluster-randomized controlled trial
Jiali Song, Xiuling Wang, Bin Wang, Yan Gao, Jiamin Liu, Haibo Zhang, Xi Li, Jing Li, Ji-Guang Wang, Jun Cai, Jeph Herrin, Jane Armitage, Harlan M. Krumholz, Xin Zheng
Effect of “Mehrpishegan” web-based support group on depression, anxiety, and stress among elderly informal caregivers: a protocol for a randomized-controlled trial
Fatemeh Rahimi, Elham Shakibazadeh, Mahnaz Ashoorkhani, Hamed Hosseini, Mahshid Foroughan
INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes
David B. Dunger, Sylvaine F. A. Bruggraber, Adrian P. Mander, M. Loredana Marcovecchio, Timothy Tree, Piotr Jaroslaw Chmura, Mikael Knip, Anke M. Schulte, Chantal Mathieu, C. Mathieu, P. Gillard, K. Casteels, L. Overbergh, D. Dunger, C. Wallace, M. Evans, A. Thankamony, E. Hendriks, S. Bruggraber, M. Peakman, T. Tree, N. Morgan, S. Richardson, J. Todd, L. Wicker, A. Mander, C. Dayan, M. Alhadj Ali, T. Pieber, D. Eizirik, M. Cnop, S. Brunak, F. Pociot, J. Johannesen, P. Rossing, C. Legido Quigley, R. Mallone, R. Scharfmann, C. Boitard, M. Knip, T. Otonkoski, R. Veijola, R. Lahesmaa, M. Oresic, J. Toppari, T. Danne, A. G. Ziegler, P. Achenbach, T. Rodriguez-Calvo, M. Solimena, E. Bonifacio, S. Speier, R. Holl, F. Dotta, F. Chiarelli, P. Marchetti, E. Bosi, S. Cianfarani, P. Ciampalini, C. de Beaufort, K. Dahl-Jørgensen, T. Skrivarhaug, G. Joner, L. Krogvold, P. Jarosz-Chobot, T. Battelino, B. Thorens, M. Gotthardt, B. Roep, T. Nikolic, A. Zaldumbide, A. Lernmark, M. Lundgren, G. Costecalde, T. Strube, A. Schulte, A. Nitsche, M. von Herrath, J. Wesley, A. Napolitano-Rosen, M. Thomas, N. Schloot, A. Goldfine, F. Waldron-Lynch, J. Kompa, A. Vedala, N. Hartmann, G. Nicolas, J. van Rampelbergh, N. Bovy, S. Dutta, J. Soderberg, S. Ahmed, F. Martin, G. Agiostratidou, A. Koralova, R. Willemsen, A. Smith, B. Anand, V. Puthi, S. Zac-Varghese, V. Datta, R. Dias, P. Sundaram, B. Vaidya, C. Patterson, K. Owen, B. Piel, S. Heller, T. Randell, T. Gazis, E. Bismuth Reismen, J-C Carel, J-P Riveline, J-F Gautier, F. Andreelli, F. Travert, E. Cosson, A. Penfornis, C. Petit, B. Feve, N. Lucidarme, E. Cosson, J-P Beressi, C. Ajzenman, A. Radu, S. Greteau-Hamoumou, C. Bibal, T. Meissner, B. Heidtmann, S. Toni, B. Rami-Merhar, B. Eeckhout, B. Peene, N. Vantongerloo, T. Maes, L. Gommers, M.L. Marcovecchio, J. Vela, E. Latres
Efficacy and safety of Lenzumestrocel (Neuronata-R® inj.) in patients with amyotrophic lateral sclerosis (ALSUMMIT study): study protocol for a multicentre, randomized, double-blind, parallel-group, sham procedure-controlled, phase III trial
Jae-Yong Nam, Tae Yong Lee, Kwijoo Kim, Sehwan Chun, Min Sung Kim, Jin-Hong Shin, Jung-Joon Sung, Byoung Joon Kim, Byung-Jo Kim, Ki-Wook Oh, Kyung Suk Kim, Seung Hyun Kim
Reducing the risk of Plasmodium vivax after falciparum infections in co-endemic areas—a randomized controlled trial (PRIMA)
Kamala Thriemer, Tamiru Shibru Degaga, Michael Christian, Mohammad Shafiul Alam, Benedikt Ley, Mohammad Sharif Hossain, Mohammad Golam Kibria, Tedla Teferi Tego, Dagimawie Tadesse Abate, Sophie Weston, Amalia Karahalios, Megha Rajasekhar, Julie A. Simpson, Angela Rumaseb, Hellen Mnjala, Grant Lee, Rodas Temesgen Anose, Fitsum Getahun Kidane, Adugna Woyessa, Kevin Baird, Inge Sutanto, Asrat Hailu, Ric N. Price
Comparative effectiveness of in-person vs. remote delivery of the Common Elements Treatment Approach for addressing mental and behavioral health problems among adolescents and young adults in Zambia: protocol of a three-arm randomized controlled trial
Caleb J. Figge, Jeremy C. Kane, Stephanie Skavenski, Emily Haroz, Mwamba Mwenge, Saphira Mulemba, Luke R. Aldridge, Michael J. Vinikoor, Anjali Sharma, Sachi Inoue, Ravi Paul, Francis Simenda, Kristina Metz, Carolyn Bolton, Christopher Kemp, Samuel Bosomprah, Izukanji Sikazwe, Laura K. Murray
Transcranial electric and acoustic stimulation for tinnitus: study protocol for a randomized double-blind controlled trial assessing the influence of combined transcranial random noise and acoustic stimulation on tinnitus loudness and distress
Mariana Lopes Martins, Tobias Kleinjung, Martin Meyer, Vithushika Raveenthiran, Zino Wellauer, Nicole Peter, Patrick Neff
The Symptom Monitoring with Feedback Trial (SWIFT): protocol for a registry-based cluster randomised controlled trial in haemodialysis
Lavern Greenham, Paul N. Bennett, Kathryn Dansie, Andrea K. Viecelli, Shilpanjali Jesudason, Rebecca Mister, Brendan Smyth, Portia Westall, Samuel Herzog, Chris Brown, William Handke, Suetonia C. Palmer, Fergus J. Caskey, Cecile Couchoud, John Simes, Stephen P. McDonald, Rachael L. Morton
Randomized double-blind, placebo-controlled study of topical diclofenac in the prevention of hand-foot syndrome in patients receiving capecitabine (the D-TORCH study)
Akhil Santhosh, Akash Kumar, Raja Pramanik, Ajay Gogia, Chandra Prakash Prasad, Ishaan Gupta, Nishkarsh Gupta, Winson Y. Cheung, Ravindra Mohan Pandey, Atul Sharma, Atul Batra
Statistical analysis plan for the randomized controlled trial Tenecteplase in Wake-up Ischaemic Stroke Trial (TWIST)
Agnethe Eltoft, Tom Wilsgaard, Melinda B. Roaldsen, Mary-Helen Søyland, Erik Lundström, Jesper Petersson, Bent Indredavik, Jukka Putaala, Hanne Christensen, Janika Kõrv, Dalius Jatužis, Stefan T. Engelter, Gian Marco De Marchis, David J. Werring, Thompson Robinson, Arnstein Tveiten, Ellisiv B. Mathiesen
Preoperative Education for Less Outpatient Pain after Surgery (PELOPS trial) in orthopedic patients—study protocol for a randomized controlled trial
Mikhail Dziadzko, Axelle Bouteleux, Raphael Minjard, Jack Harich, Fanny Joubert, Pierre Pradat, Solene Pantel, Frederic Aubrun
The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory
Emily C. O’Brien, Jeremy Sugarman, Kevin P. Weinfurt, Eric B. Larson, Patrick J. Heagerty, Adrian F. Hernandez, Lesley H. Curtis
Effects of different doses of methylprednisolone on clinical outcomes in patients with severe community-acquired pneumonia: a study protocol for a randomized controlled trial
Shukun Hong, Hongye Wang, Jian Liu, Lujun Qiao
Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial
Jari Planert, Alla Machulska, Anne-Sophie Hildebrand, Kati Roesmann, Esra Otto, Tim Klucken
Effectiveness of multimodal exercises integrated with cognitive-behavioral therapy in working patients with chronic neck pain: protocol of a randomized controlled trial with 1-year follow-up
M. Monticone, S. Simone Vullo, L. I. Lecca, F. Meloni, I. Portoghese, M. Campagna
A multimodal intervention to optimise antimicrobial use in residential aged care facilities (ENGAGEMENT): protocol for a stepped-wedge cluster randomised trial
Nazanin Falconer, David L. Paterson, Nancye Peel, Alyssa Welch, Christopher Freeman, Ellen Burkett, Ruth Hubbard, Tracy Comans, Leila Shafiee Hanjani, Elaine Pascoe, Carmel Hawley, Leonard Gray
Multisite randomised controlled trial of trauma-focused cognitive behaviour therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to treatment as usual: study protocol for the STAR (Study of Trauma And Recovery) trial
Emmanuelle Peters, Amy Hardy, Robert Dudley, Filippo Varese, Kathryn Greenwood, Craig Steel, Richard Emsley, Nadine Keen, Samantha Bowe, Sarah Swan, Raphael Underwood, Eleanor Longden, Sarah Byford, Laura Potts, Margaret Heslin, Nick Grey, Doug Turkington, David Fowler, Elizabeth Kuipers, Anthony Morrison
The NICU Antibiotics and Outcomes (NANO) trial: a randomized multicenter clinical trial assessing empiric antibiotics and clinical outcomes in newborn preterm infants
Michael J. Morowitz, Anup C. Katheria, Richard A. Polin, Elizabeth Pace, David T. Huang, Chung-Chou H. Chang, Johathan G. Yabes
Evolocumab administration prior to Coronary Artery Bypass Grafting in patients with multivessel coronary artery disease (EVOCABG): study protocol for a randomized controlled clinical trial
Hye Rim Na, O Sung Kwon, Joon Kyu Kang, Yong Han Kim, Ju Yong Lim
The use of transcranial direct current stimulation (tDCS) to reduce impulsivity and aggression in adults with mild intellectual developmental disabilities: the tDCS-RIADD randomised controlled trial protocol
Najat Khalifa, Emily R. Hawken, Andrew Bickle, Mariel Cabrera, Travis Heath, Andrew Drury, Jessica Jones, Muhammad Ayub
A randomized controlled trial to assess the efficacy of Parenting-STAIR in treating maternal PTSD to reduce maltreatment recidivism: protocol for the Safe Mothers, Safe Children study
Michael Lindsey, Kathrine Sullivan, Claude Chemtob, Kelly Ancharski, James Jaccard, Marylène Cloitre, Anthony Urquiza, Susan Timmer, Mercedes Okosi, Debra Kaplan
Investigating the efficacy of baricitinib in new onset type 1 diabetes mellitus (BANDIT)—study protocol for a phase 2, randomized, placebo controlled trial
M. Waibel, H. E. Thomas, J. M. Wentworth, J. J. Couper, R. J. MacIsaac, F. J. Cameron, M. So, B. Krishnamurthy, M. C. Doyle, T. W. Kay
The effect of Rosa canina L. and a polyherbal formulation syrup in patients with attention-deficit/hyperactivity disorder: a study protocol for a multicenter randomized controlled trial
Haide Golsorkhi, Mostafa Qorbani, Mohammad Kamalinejad, Saeideh Sabbaghzadegan, Mohsen Bahrami, Mohammad Vafaee-Shahi, Hadi Montazerlotfelahi, Elham Abniki, Majid Dadmehr
Cost-effectiveness of a smartphone Application for Tinnitus Treatment (the CATT trial): a study protocol of a randomised controlled trial
Sara Demoen, Laure Jacquemin, Annick Timmermans, Vincent Van Rompaey, Olivier Vanderveken, Hanne Vermeersch, Iris Joossen, Julie Van Eetvelde, Winfried Schlee, Wim Marneffe, Janis Luyten, Annick Gilles, Sarah Michiels
Are preoperative oral antibiotics effective in reducing the incidence of anastomotic leakage after colorectal cancer surgery? Study protocol for a prospective, multicentre, randomized controlled study
Rui Qi Gao, Wei Dong Wang, Peng Fei Yu, Zhen Chang Mo, Dan Hong Dong, Xi Sheng Yang, Xiao Hua Li, Gang Ji
Efficacy and safety of Elian Granules in treating chronic atrophic gastritis: study protocol for a randomized, double-blind, placebo-controlled, multicenter clinical trial
Zhijian Gu, Qingling Jia, Jun Cong, Rong Cen, Yongqi Chen, Chenheng Wu, Biao Gong, Xudong Tang, Jianghong Ling
Correction: Implementing a personalized pharmaceutical plan in kidney or liver transplant patients: study protocol for a stepped-wedge cluster randomized trial (GRePH)
Xavier Pourrat, Elise Berthy, Antoine Dupuis, Louise Barbier, Matthias Buchler, Leslie Grammatico Guillon, Fanny Monmousseau, Eric Ruspini, Ephrem Salamé, Solène Brunet Houdard, Bruno Giraudeau
Peer specialists deliver cognitive behavioral social skills training compared to social skills training and treatment as usual to veterans with serious mental illness: study protocol for a randomized controlled trial
Chantele Mitchell-Miland, Sharon McCarthy, Matthew Chinman
Effectiveness of a community health worker-delivered care intervention for hypertension control in Uganda: study protocol for a stepped wedge, cluster randomized control trial
Rebecca Ingenhoff, Juliet Nandawula, Trishul Siddharthan, Isaac Ssekitoleko, Richard Munana, Benjamin E. Bodnar, Ivan Weswa, Bruce J. Kirenga, Gerald Mutungi, Markus van der Giet, Robert Kalyesubula, Felix Knauf
Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial
Andrew Medina-Marino, Susan Cleary, Christina A. Muzny, Christopher Taylor, Ashutosh Tamhane, Phuti Ngwepe, Charl Bezuidenhout, Shelley N. Facente, Koleka Mlisana, Remco P. H. Peters, Jeffrey D. Klausner
Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke
Lynden Rodrigues, Kevin Moncion, Janice J. Eng, Kenneth S. Noguchi, Elise Wiley, Bernat de Las Heras, Shane N. Sweet, Joyce Fung, Marilyn MacKay-Lyons, Aimee J. Nelson, Diogo Medeiros, Jennifer Crozier, Alexander Thiel, Ada Tang, Marc Roig
Long-term health outcomes of adolescent character strength interventions: 3- to 4-year outcomes of three randomized controlled trials of the Shamiri program
Katherine E. Venturo-Conerly, Natalie E. Johnson, Tom L. Osborn, Eve S. Puffer, Thomas Rusch, David M. Ndetei, Christine M. Wasanga, Victoria Mutiso, Christine Musyimi, John R. Weisz
Efficacy and safety of artesunate for patients with IgA nephropathy: a study protocol for a multicenter, double-blind, randomized, placebo-controlled trial
Qi Chen, Zi Wang, Jicheng Lv, Lijun Liu, Hang Li, Weiwei Sun, Yanhong Huo, Yingbo Guo, Cun Shen, Shichao Li, Zhenjie Chen, Jingwei Zhou
Health Information and Monitoring of Sexually Transmitted Infections (SIM study): a single-center, parallel, three-arm randomized controlled trial protocol for enhancing adherence to syphilis treatment and follow-up
Eliana M. Wendland, Vanessa M. de Oliveira, Luana Giongo Pedrotti, Flavia M. A. Souza, Gerson F. M. Pereira, Antonio Gerbase
Ma’s bamboo-based medicinal moxibustion therapy of low back pain in lumbar disc herniation: study protocol for a randomized controlled trial
Xian-zhu Wang, Kai-yang Xue, Ping-nan Chen, Cai-hong Xiao, Jin Cui, Jing Fu
Efficacy and safety of Gyejibokryeong-hwan (GBH) in major depressive disorder: study protocol for multicentre randomised controlled trial
Yujin Choi, In Chul Jung, Ju Yeon Kim, Seung-Hun Cho, Yunna Kim, Sun-Yong Chung, Hui-Yong Kwak, Doo Suk Lee, Wonwoo Lee, In-Jeong Nam, Changsop Yang, Mi Young Lee
Effectiveness and cost-effectiveness of sector-independent treatment coordination for people with substance-related disorders following an online assessment (ASSIST): study protocol for a randomized controlled trial
Annabel S. Mueller-Stierlin, Jeanette Röhrig, Christian Goetzl, Michael Krausz, Jutta Lehle, Elke Prestin, Vanessa-Emily Schoch, Lorenz Sutter, Jean Westenberg, Maurice Cabanis
ALIMUS—We are feeding! Study protocol of a multi-center, cluster-randomized controlled trial on the effects of a home garden and nutrition counseling intervention to reduce child undernutrition in rural Burkina Faso and Kenya
Isabel Mank, Raissa Sorgho, Fanta Zerbo, Moubassira Kagoné, Boubacar Coulibaly, John Oguso, Michael Mbata, Sammy Khagayi, Erick M. O. Muok, Ali Sié, Ina Danquah
Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study
Corina Benjet, Ronald C. Kessler, Alan E. Kazdin, Pim Cuijpers, Yesica Albor, Nayib Carrasco Tapias, Carlos C. Contreras-Ibáñez, Ma Socorro Durán González, Sarah M. Gildea, Noé González, José Benjamín Guerrero López, Alex Luedtke, Maria Elena Medina-Mora, Jorge Palacios, Derek Richards, Alicia Salamanca-Sanabria, Nancy A. Sampson
A virtual reality home-based training for the management of stress and anxiety among healthcare workers during the COVID-19 pandemic: study protocol for a randomized controlled trial
Federica Pallavicini, Eleonora Orena, Simona di Santo, Luca Greci, Chiara Caragnano, Paolo Ranieri, Costanza Vuolato, Alessandro Pepe, Guido Veronese, Stefano Stefanini, Federica Achille, Antonios Dakanalis, Luca Bernardelli, Francesca Sforza, Angelo Rossini, Carlo Caltagirone, Sara Fascendini, Massimo Clerici, Giuseppe Riva, Fabrizia Mantovani
The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers
Avery C. Bechthold, Andres Azuero, Maria Pisu, Jennifer Young Pierce, Grant R. Williams, Richard A. Taylor, Rachel Wells, Kayleigh Curry, Rhiannon D. Reed, Erin R. Harrell, Shena Gazaway, Sarah Mollman, Sally Engler, Frank Puga, Marie A. Bakitas, J. Nicholas Dionne-Odom
Surgical versus non-surgical treatment of humeral SHAFT fractures compared by a patient-reported outcome: the Scandinavian Humeral diAphyseal Fracture Trial (SHAFT)—a study protocol for a pragmatic randomized controlled trial
Dennis Karimi, Stig Brorson, Kaare S. Midtgaard, Tore Fjalestad, Aksel Paulsen, Per Olerud, Carl Ekholm, Olof Wolf, Bjarke Viberg, Katharina Stohlmann, Bamo Jalal, Christian Cavallius, Esben S. Pedersen, Frede Frihagen, Frederik Stensbirk, Henrik Illerström, Jens Knak, Anne Marie Nyholm, Jesper Schønnemann, Joakim Jensen, Jonas Sundkvist, Mads Vinding, Peter M. Siesing, Srdjan Zivanovic, Søren Kring
Zhizhu Kuanzhong Capsule in treating patients with functional dyspepsia postprandial distress syndrome: study protocol for a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial
Mengli Xiao, Linda L. D. Zhong, Wai Ching Lam, Yingpan Zhao, Kok-Ann Gwee, Gerald Holtmann, Jan Tack, Hidekazu Suzuki, Min-Hu Chen, Yinglian Xiao, Xiaohua Hou, Jinsong Liu, Yang Li, Xu-Dong Tang, Fang Lu
Efficacy and safety of Jian-Pi Huo-Xue granule for non-alcoholic fatty liver disease: study protocol for a randomized, double-blind, placebo-controlled trial
Yuanlong Sun, Gaofeng Chen, Si Chen, Yanjie Wang, Yiyang Hu, Yu Zhao
Value and engagement: what can clinical trials learn from techniques used in not-for-profit marketing?
E. J. Mitchell, K. Sprange, S. Treweek, E. Nixon
PragmaTic, prospEctive, randomized, controlled, double-blind, mulTi-centre, multinational study on the safety and efficacy of a 6% HydroxYethyl Starch (HES) solution versus an electrolyte solution in trauma patients: study protocol for the TETHYS study
Clementina Duran Palma, Musawenkosi Mamba, Johan Geldenhuys, Oluwafolajimi Fadahun, Rolf Rossaint, Kai Zacharowski, Martin Brand, Óscar Díaz-Cambronero, Javier Belda, Martin Westphal, Ute Brauer, Dirk Dormann, Tamara Dehnhardt, Martin Hernandez-Gonzalez, Sonja Schmier, Dianne de Korte, Frank Plani, Wolfgang Buhre
Tolerating bad health research: the continuing scandal
Stefania Pirosca, Frances Shiely, Mike Clarke, Shaun Treweek
Comparative effectiveness of aerobic exercise versus Yi Jin Jing on ovarian function in young overweight/obese women with polycystic ovary syndrome: study protocol for a randomized controlled trial
Jing Zhao, Antonnette Ketlhoafetse, Xiangyun Liu, Yang Cao
Clinical trial registration during COVID-19 and beyond in the African context: what have we learned?
Lindi Mathebula, Sinazo Runeyi, Charles Wiysonge, Duduzile Ndwandwe
A self-efficacy-enhancing physical activity intervention in women with high-risk factors for gestational diabetes mellitus: study protocol for a randomized clinical trial
Xiao Yang, Ji Zhang, Xiangzhi Wang, Yi Xu, Li Sun, Yingli Song, Ruijuan Bai, Hui Huang, Jing Zhang, Ruixing Zhang, Erfeng Guo, Lingling Gao
Therapeutic effects and central mechanism of acupuncture and moxibustion for treating functional dyspepsia: study protocol for an fMRI-based randomized controlled trial
Pan Zhang, Tao Yin, Yang-Ke Mao, Zhao-Xuan He, Sha Yang, Si-Qin Huang, Rui-Rui Sun, Fang Zeng
Testing a social network approach to promote HIV self-testing and linkage to care among fishermen at Lake Victoria: study protocol for the Owete cluster randomized controlled trial
Lila A. Sheira, Zachary A. Kwena, Edwin D. Charlebois, Kawango Agot, Benard Ayieko, Monica Gandhi, Elizabeth A. Bukusi, Harsha Thirumurthy, Carol S. Camlin
Living with Loss: study protocol for a randomized controlled trial evaluating an internet-based perinatal bereavement program for parents following stillbirth and neonatal death
Siobhan A. Loughnan, Frances M. Boyle, David Ellwood, Sara Crocker, Ann Lancaster, Chrissie Astell, Julie Dean, Dell Horey, Emily Callander, Claire Jackson, Antonia Shand, Vicki Flenady
The efficacy and safety of acupuncture and nicotine replacement therapy for smoking cessation: study protocol for a randomized controlled trial
Qingsheng Wang, Runjing Dai, Hailiang Zhang, Xiaomei Jiang, Xiaojing Ma, Xiangrong Zhang, Shisan Bao, Dong Ren, Jingchun Fan
Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone
Onome T. Abiri, Abdulai J. Bah, Michael Lahai, Durodami R. Lisk, James P. Komeh, Joy Johnson, Wiltshire C. N. Johnson, Sheku S. Mansaray, Joseph Sam Kanu, James B. W. Russell, Fawzi Thomas, Murtada M. Sesay, Thomas A. Conteh, Alphan Tejan-Kella, Mohamed Sesay, Manal Ghazzawi, Brian Thompson, Sorie Conteh, Gibrilla Fadlu Deen
Continuous or interrupted suture technique for hepaticojejunostomy during pancreatoduodenectomy (HEKTIK trial): study protocol of a randomized controlled multicenter trial
Maximilian Brunner, Henriette Golcher, Christian Krautz, Stephan Kersting, Georg F. Weber, Robert Grützmann
Prehabilitation of elderly frail or pre-frail patients prior to elective surgery (PRAEP-GO): study protocol for a randomized, controlled, outcome assessor-blinded trial
Stefan J. Schaller, Jörn Kiselev, Verena Loidl, Wilm Quentin, Katrin Schmidt, Rudolf Mörgeli, Tanja Rombey, Reinhard Busse, Ulrich Mansmann, Claudia Spies, Claudia Spies, Ursula Marschall, Rahel Eckardt-Felmberg, Irmgard Landgraf, Ulrich Schwantes, Reinhard Busse, Ulrich Mansmann, Friedrich Borchers, Rudolf Mörgeli, Eva Schönenberger, Philipp Klassen, Bernadette Kleikamp, Philipp Brandhorst, Anna-Lena H. Spiegel, Bernhard Papenfuß, Jens Dowideit, Caroline Oefele, Volker Gebhardt, Kristina Zappel, Mehmet Gövercin, Thomas König, Claudio Chesi, Anett Reißhauer, Adrian Rosada, Ursula Müller-Werdan, Anja Heymann, Marion Hanke, Jens Leymann, Thomas Saller, Ann-Cathrin Bischof, Angelika Reisner, Wolf Leopold Albrecht, Julia Wojciechowski, Martina Schuldt, Michael Baum, Dijana Brnabic, Björn von Pickardt, Agnieszka Deutschmann, Carsten Scholz, Lars May, Rahel Eckardt-Felmberg, Isabell Wenghöfer, Manfred Blobner, Sima Sattari, Michael Dummert, Carla Nau, Mareike Otto, Ute Voß-Lümers, Danny Lang, Daniel Wiggert
Influence of kinesiophobia on pain intensity, disability, muscle endurance, and position sense in patients with chronic low back pain—a case-control study
Praveen Kumar Kandakurti, Watson Arulsingh, Sharad S Patil
Ruxolitinib-corticosteroid as first-line therapy for newly diagnosed high-risk acute graft versus host disease: study protocol for a multicenter, randomized, phase II controlled trial
Liping Dou, Bo Peng, Xin Li, Lu Wang, Mingyu Jia, Lingmin Xu, Fei Li, Daihong Liu
Unpacking the ‘black box of horrendousness’: a qualitative exploration of the barriers and facilitators to conducting trials involving adults lacking capacity to consent
Victoria Shepherd, Kerenza Hood, Fiona Wood
The efficacy of curcumin-piperine co-supplementation on clinical symptoms, duration, severity, and inflammatory factors in COVID-19 outpatients: a randomized double-blind, placebo-controlled trial
Gholamreza Askari, Amirhossein Sahebkar, Davood Soleimani, Atena Mahdavi, Sahar Rafiee, Muhammed Majeed, Farzin Khorvash, Bijan Iraj, Mahshid Elyasi, Mohammad Hossein Rouhani, Mohammad Bagherniya
INSPIRA: study protocol for a randomized-controlled trial about the effect of spirometry-assisted preoperative inspiratory muscle training on postoperative complications in abdominal surgery
D. L. Birrer, C. Kuemmerli, A. Obwegeser, M. Liebi, S. von Felten, K. Pettersson, K. Horisberger
Keeping up with the guidelines: design changes to the STREAM stage 2 randomised controlled non-inferiority trial for rifampicin-resistant tuberculosis
Ruth L. Goodall, Karen Sanders, Gay Bronson, Meera Gurumurthy, Gabriela Torrea, Sarah Meredith, Andrew Nunn, I. D. Rusen, Gay Bronson, Meera Gurumurthy, Jan Komrska, Leena Patel, Ishmael Qawiy, I. D. Rusen, Sonia Ali, Katharine Bellenger, Deborah Bennet, Rachel Bennet, Wendy Dodds, Ruth Goodall, Sarah Meredith, Brendan Murphy, Andrew Nunn, Carol Roach, Karen Sanders, Johanna Whitney, Armand Van Deun, Gabriela Torrea, Chen-Yuan Chiang, Laura Rosu, Bertie Squire, Jason Madan
Behavioural intervention to promote the uptake of planned care in urgent dental care attenders: study protocol for the RETURN randomised controlled trial
R. Harris, V. Lowers, C. Hulme, G. Burnside, A. Best, J. E. Clarkson, R. Cooke, M. Van Der Zande, R. Maitland
Efficacy and safety of piezocision in accelerating maxillary anterior teeth en-masse retraction: study protocol for a randomized controlled trial
Yichen Xu, Liming Yu, Xianqin Tong, Yuhui Wang, Yuanyuan Li, Jie Pan, Yanjing Yang, Yuehua Liu
E-HEalth treatment in Long-term Dialysis (E-HELD): study protocol for a multicenter randomized controlled trial evaluating personalized Internet-based cognitive-behavioral therapy in dialysis patients
Judith Tommel, Andrea W. M. Evers, Henk W. van Hamersvelt, Sandra van Dijk, Niels H. Chavannes, Lieke Wirken, Luuk B. Hilbrands, Henriët van Middendorp
Ventilator-associated pneumonia prevention in the Intensive care unit using Postpyloric tube feeding in China (VIP study): study protocol for a randomized controlled trial
Linhui Hu, Kaiyi Peng, Xiangwei Huang, Zheng Wang, Quanzhong Wu, Yumei Xiao, Yating Hou, Yuemei He, Xinjuan Zhou, Chunbo Chen
Effectiveness of the MULTIPAP Plus intervention in youngest-old patients with multimorbidity and polypharmacy aimed at improving prescribing practices in primary care: study protocol of a cluster randomized trial
Isabel del Cura-González, Juan A. López-Rodríguez, Francisca Leiva-Fernández, Luis A. Gimeno-Feliu, Victoria Pico-Soler, Mª. Josefa Bujalance-Zafra, Miguel Domínguez-Santaella, Elena Polentinos-Castro, Beatriz Poblador-Plou, Paula Ara-Bardají, Mercedes Aza-Pascual-Salcedo, Marisa Rogero-Blanco, Marcos Castillo-Jiménez, Cristina Lozano-Hernández, Antonio Gimeno-Miguel, Francisca González-Rubio, Rodrigo Medina-García, Alba González-Hevilla, Mario Gil-Conesa, Jesús Martín-Fernández, José M. Valderas, Alessandra Marengoni, Christiane Muth, J. Daniel Prados-Torres, Alexandra Prados-Torres, Francisco Javier Orellana-Lozano, Jesús Sepúlveda-Muñoz, Rafael Sánchez-Jordán, Amparo Escobar-Pérez, Concepción Rodríguez-García, Trinidad Peñuela-Ruiz, José Antonio Navarro-Martín, María Rosario Rodríguez-Rivera, Yolanda Aguilar-Heredia, Antonio Ignacio Martínez-Sarmiento, Beatriz Pascual-de-la-Pisa, María José García-Lozano, Alejandro García-Carrera, Noelia Juan-Tordesillas, María Isabel Márquez-Chamizo, José Manuel Navarro-Jiménez, María Carmen Ruiz-Ciudad, Rubén Luciano Vázquez-Alarcón, María Isabel Navarro-Gallego, Leovigildo Ginel-Mendoza, José María Ruiz-San-Basilio, Elena Barceló-Garach, Elisa María Alcantarilla-Reyes, Marta Álvarez de Cienfuegos Hernández, Irene Martínez-Ríos, Laura Orellana-Martín, María Dolores Merino-Moyano, Nuria Segura-Domínguez, María Cristina Moral-Merchán, Esther Martín-Aurioles, María Inmaculada Rodríguez-González, Sylvia Hazañas-Ruiz, Eva Noelia Gallego-Castillo, Esperanza Mora-García, Estefanía Cámara-Sola, Sergio Fons-Cañizares, María Paz Ortigosa-Arrabal, Teresa Quesada-Fernández, Silvia Rodríguez-Moreno, Ana Sánchez-Silvestre, María Jesús Torrubia-Fernández, María José González-Vega, María Victoria Almagro-Martín-Lomeña, Caridad Serrano-González, José Leiva-Fernández, Virginia Castillo-Romero, Ana María Fernández-Vargas, Francisco José Serrano-Guerra, Gabriel Francisco Narbona-Carrión, Hervé Michel-Bertevas, Rafael Ángel Maqueda, Miguel Domínguez-Santaella, Nuria García-Agua-Soler, Maria del Pilar Barnestein-Fonseca, María Begoña Abadía-Taira, Carmen Sánchez-Celaya-del-Pozo, Ana Carmen Giménez-Baratech, Lara Sanz-Burgos, Mercedes Abad-Royo, Carmen Camats-Franco, José Manuel Cortés-Pellicer, Paula Herrero-Solsona, Aida Moreno-Juste, Miguel Guiu-Campos, Nima Peyman-Fard-Shafi-Tabatabaei, Ma Teresa Delgado-Marroquín, Mercedes López-Echevarría, Jonás Carmona-Pírez, Fernando Barrera-Linares, Sandro Daniel Carrillo-Soria, Ana Belén Esteban-Gimeno, Beatriz López-Alonso, Anabel Hernández-Bono, Enrique Martínez-Ayala, Adriana Martínez-Manero, Raquel Martínez-Sánchez, Yolanda Naya-Mateu, María Lourdes Clemente-Jiménez, María Paz Leon-Martínez, Liliana Mahuela, Ma Rosario Sanjuan-Cortés, Elisa Pilar Salazar-González, Ma Elena Charte-Alegre, Ma Jesús Mur-Lazuela, Mónica Pascual-Franco, Pilar Arizon-Deza, Carmen García-Gutiérrez-Muñoz, Teresa García-Ruiz, Gloria Navarro-Aznárez, Carlos Alcober-Pérez, María Paz Navarro-Tausiet, Ma Elena Lacasa-Serrano, Ana Cristina Maza-Invernón, Jaime Peleato-Sánchez, José Miguel Buñuel-Granados, Ainara Alonso-Valbuena, Mónica Lasheras-Barrio, Isabel Ibarrondo-Fernández-Ladreda, Rosa Ma López-Aylon, María José Rodríguez-Fabre, Isabel Rubio-Gutiérrez, Selma Valverde-Aranda, Ana Cristina Bandrés-Liso, Antonio Poncel-Falcó, Kevin Bliek-Bueno, Mabel Cano-del-Pozo, Mercedes Clerencia-Sierra, Jesús Díez-Manglano, Inmaculada Guerrero-Fernández-de-Alba, Ignatios Ioakeim-Skoufa, Javier Marta-Moreno, David Santos-Muñoz, María Elisa Viñuela-Benéitez, María De Los Angeles Miguel-Abanto, Francisca García-De-Blas, Juan Carlos García-Álvarez, Sonia Redondo-de-Pedro, Carlos Fernando González-García, Carolina Peláez-Laguno, Esther Gomez-Suarez, Fernanda Morales-Ortiz, Isabel Ferrer-Zapata, Yolanda Beatriz Sánchez-Fernández, Yolanda Fernández-Fernández, Esther Barrio-Higelmo, Eva María Rioja-Delgado, Irina Lopez-Larrayoz, María Luz Seara-Lozano, Julio Cesar Fernández-Sánchez, María Teresa San-Miguel-Marinero, María Jesus Fidalgo-Baz, Sara Ares-Blanco, Jorge Ignacio Gómez-Ciriano, José Damián Garcés-Ranz, Laura Santos-Franco, María Celeste García-Galeano, Raquel Mateo-Fernández, Sara Morcillo-Cebolla, Tomás Rossignoli-Fernández, Jorge Olmedo-Galindo, Marta Pinel-González, Rosa María Redondo-Romero, Adnaloy Helena Estrada-Leon, Belén Muñoz-Gómez, Blanca Sanz-Pozo, Claudia López-Marcos, Enrique Rodríguez-De-Mingo, Juan Carlos Moreno-Fernández, Luis Enrique Morales-Cobos, María Del Prado Garcia-Garcia-Alcañiz, Marisol Lorenzo-Borda, Vera González-García, María Del Pilar Muñoz-Molina, Yasmin Drak-Hernández, Alejandro Rabanal-Basalo, Ana María Abad-Esteban, María De Los Ángeles Rollan-Hernández, Mónica Fuster-Tozer, Raquel Carretero-Ramos, Rebeca Mielgo-Salvador, Ana Sosa-Alonso, Carmen María Muros-Muñoz, Jeannet Dolores Sánchez-Yépez, María Cristina Cáceres-Cortés, María Paloma Morso-Peláez, María Pastor-Estebanez, Mercedes Fernández-Girón, Antonia Pérez-De-Colosia-Zuil, Esteban Pérez-Gutiérrez, Isabel Tejero-García, Jaime Innerarity-Martínez, Mar Álvarez-Villalba, Margarita Gómez-Barroso, María Del Mar Escobar-Gallegos, María Jesus Bedoya-Frutos, Marta Inmaculada Del-Olmo-Ribagorda, Petra María Cortés-Durán, Pilar Tardáguila-Lobato, Raquel Yolanda Terrón-Barbosa, Antonio Ramos-Blanco, Aránzazu López-Villalvilla, Beatriz Cinta-Bella, Cristian Varela-Varela, Francisca Garcia-Rodriguez, Gema María Saiz-Ladera, Guillermina López-Fernández, Lourdes Orozco-Barrenechea, María Begoña Zafra-De-Gea, Nuria García-Arpa, Tamara Ewa-Barnas, Ana Isabel Carbonero-Martín, María José Rojas-Giraldo, Alberto Cotillas-Rodero, Beatriz López-Serrano, María Del Carmen Rodriguez-Fernández, Carmelina Sanz-Velasco, Jose Ignacio Aza-Pascual-Salcedo, Carolina Lopez-Olmeda, Estrella Gutiérrez-Ocana, Raquel García-Ocaña, Teresa Sanz-Cuesta, Ricardo Rodríguez-Barrientos, Milagros Rico-Blázquez, Ma Gloria Ariza-Cardiel, Angel Mataix-San-Juan, Marta Alcaraz-Borrajo, Mercedes Rumayor-Zarzuelo, Luis Sánchez-Perruca, Amaya Azcoaga-Lorenzo, Virginia Hernández-Santiago, Rafael Rotaeche-del-Campo
Rifapentine and isoniazid for prevention of tuberculosis in people with diabetes (PROTID): protocol for a randomised controlled trial
Nyanda Elias Ntinginya, Lindsey te Brake, Issa Sabi, Nyasatu Chamba, Kajiru Kilonzo, Sweetness Laizer, Irene Andia-Biraro, Davis Kibirige, Andrew Peter Kyazze, Sandra Ninsiima, Julia A. Critchley, Renee Romeo, Josephine van de Maat, Willyhelmina Olomi, Lucy Mrema, David Magombola, Issakwisa Habakkuk Mwayula, Katrina Sharples, Philip C. Hill, Reinout van Crevel
The effect of a probiotic on gastrointestinal symptoms due to menstruation in healthy adult women on oral contraceptives: randomized, double-blind, placebo-controlled trial protocol
Taylor C. Judkins, Marie-Laure Oula, Shireen Madani Sims, Bobbi Langkamp-Henken
Effect of time restricted feeding on anthropometric measures, eating behavior, stress, and brain-derived neurotrophic factor (BDNF) and lipopolysaccharide-binding protein (LBP) levels in women with overweight/obesity and food addiction: a study protocol for a randomized clinical trial
Hanieh Irani, Banafsheh Khodami, Behnaz Abiri, Atoosa Saidpour
Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial
C. R. Keohane, D. Westby, M. Twyford, T. Ahern, W. Tawfick, S. R. Walsh
TB-PRACTECAL: study protocol for a randomised, controlled, open-label, phase II–III trial to evaluate the safety and efficacy of regimens containing bedaquiline and pretomanid for the treatment of adult patients with pulmonary multidrug-resistant tuberculosis
Catherine Berry, Philipp du Cros, Katherine Fielding, Suzanne Gajewski, Emil Kazounis, Timothy D. McHugh, Corinne Merle, Ilaria Motta, David A. J. Moore, Bern-Thomas Nyang’wa
Establishing a core outcome set for neurogenic bladder trials: study protocol for a scoping review and Delphi surveys
Yan Zhang, Yamin Chen, Mingming Niu, Yuanyuan Li, Jiaoyan Zhang, Li Zhang, Fangfang Wu, Qingyun Chen, Huijin Yu, Jinhui Tian
Effect of smartphone app-based health care intervention for health management of high-risk mothers: a study protocol for a randomized controlled trial
Bora Kim, Jong Youn Moon, Jae Yong Shin, Hae Rin Jeon, So Yeon Oh, Suk Young Kim
Communication Bridge™-2 (CB2): an NIH Stage 2 randomized control trial of a speech-language intervention for communication impairments in individuals with mild to moderate primary progressive aphasia
Angela C. Roberts, Alfred W. Rademaker, Elizabeth Ann Salley, Aimee Mooney, Darby Morhardt, Melanie Fried-Oken, Sandra Weintraub, Marsel Mesulam, Emily Rogalski
Influence on study outcomes of an inpatient study by the behavior of the study staff (PINgPOng): study protocol for a randomized clinical trial
Martin Coenen, Ulrike Bingel, Matthias Zunhammer, Maria Soledad Berdaguer, Christine Fuhrmann, Rolf Fimmers, Jens Rengelshausen, Gunther Hartmann, Manfred Schedlowski, Christoph Coch
Correction: ALIMUS—We are feeding! Study protocol of a multi-center, cluster-randomized controlled trial on the effects of a home garden and nutrition counseling intervention to reduce child undernutrition in rural Burkina Faso and Kenya
Isabel Mank, Raissa Sorgho, Fanta Zerbo, Moubassira Kagoné, Boubacar Coulibaly, John Oguso, Michael Mbata, Sammy Khagayi, Erick M. O. Muok, Ali Sié, Ina Danquah
Efficacy of dexmedetomidine on postoperative pain in patients undergoing gastric and esophageal endoscopic submucosal dissection: a study protocol for a randomized controlled prospective trial
Xin Luo, Li-Xin An, Pei-Shan Chen, Xin-Lu Chang, Yang Li
Evaluating the effectiveness of stepwise swallowing training on dysphagia in patients with Alzheimer’s disease: study protocol for a randomized controlled trial
Chenxin Wu, Kun Zhang, Junrong Ye, Xingxiao Huang, Hang Yang, Lexin Yuan, Haoyun Wang, Ting Wang, Xiaomei Zhong, Jianxiong Guo, Lin Yu, Aixiang Xiao
The effects of different surgical positions (semi-sitting and lateral position) on the surgical outcomes of large vestibular schwannoma: study protocol for a randomized controlled trial
Xiaolong Wu, Xu Wang, Gang Song, Mingchu Li, Chengbei Hou, Ge Chen, Hongchuan Guo, Xinru Xiao, Jie Tang, Qingtang Lin, Yuhai Bao, Jiantao Liang
NSAIDs in sciatica (NIS): study protocol for an investigator-initiated multicentre, randomized placebo-controlled trial of naproxen in patients with sciatica
Lars Grøvle, Eivind Hasvik, Rene Holst, Anne Julsrud Haugen
Prediction Aided Tapering In rheumatoid arthritis patients treated with biOlogicals (PATIO): protocol for a randomized controlled trial
Marianne A. Messelink, Matthijs S. van der Leeuw, Alfons A. den Broeder, Janneke Tekstra, Marlies C. van der Goes, Marloes W. Heijstek, Floris Lafeber, Paco M. J. Welsing
Doxycycline post-exposure prophylaxis for prevention of sexually transmitted infections among Kenyan women using HIV pre-exposure prophylaxis: study protocol for an open-label randomized trial
Jenell Stewart, Elizabeth Bukusi, Fredericka A. Sesay, Kevin Oware, Deborah Donnell, Olusegun O. Soge, Connie Celum, Josephine Odoyo, Zachary A. Kwena, Caitlin W. Scoville, Lauren R. Violette, Susan Morrison, Jane Simoni, R. Scott McClelland, Ruanne Barnabas, Monica Gandhi, Jared M. Baeten
Internet-based vestibular rehabilitation versus standard care after acute onset vertigo: a study protocol for a randomized controlled trial
Solmaz Surano, Helena Grip, Fredrik Öhberg, Marcus Karlsson, Erik Faergemann, Maria Bjurman, Hugo Davidsson, Torbjörn Ledin, Ellen Lindell, Jan Mathé, Fredrik Tjernström, Tatjana Tomanovic, Gabriel Granåsen, Jonatan Salzer
Study protocol for a randomised, patient- and observer-blinded evaluation of P6 acustimulation for the prevention of nausea and vomiting in the postoperative period in patients receiving routine pharmacological prophylaxis (P6NV-Trial)
Benedict Weber, Selena Knoth, Peter Kranke, Leopold Eberhart
Evaluation of the safety and immunogenicity of different COVID-19 vaccine combinations in healthy individuals: study protocol for a randomized, subject-blinded, controlled phase 3 trial [PRIBIVAC]
Xuan Ying Poh, I. Russel Lee, Clarissa Lim, Jefanie Teo, Suma Rao, Po Ying Chia, Sean W. X. Ong, Tau Hong Lee, Ray J. H. Lin, Lisa F. P. Ng, Ee Chee Ren, Raymond T. P. Lin, Lin-Fa Wang, Laurent Renia, David Chien Lye, Barnaby E. Young
Fluconazole in hypercalciuric patients with increased 1,25(OH)2D levels: the prospective, randomized, placebo-controlled, double-blind FLUCOLITH trial
Aurélia Bertholet-Thomas, Aurélie Portefaix, Sacha Flammier, Carole Dhelens, Fabien Subtil, Laurence Dubourg, Valérie Laudy, Myrtille Le Bouar, Inesse Boussaha, Marietou Ndiaye, Arnaud Molin, Sandrine Lemoine, Justine Bacchetta
The clinical effectiveness and cost-effectiveness of a ‘stepping into day treatment’ approach versus inpatient treatment as usual for anorexia nervosa in adult specialist eating disorder services (DAISIES trial): a study protocol of a randomised controlled multi-centre open-label parallel group non-inferiority trial
Madeleine Irish, Bethan Dalton, Laura Potts, Catherine McCombie, James Shearer, Katie Au, Nikola Kern, Sam Clark-Stone, Frances Connan, A. Louise Johnston, Stanimira Lazarova, Shiona Macdonald, Ciarán Newell, Tayeem Pathan, Jackie Wales, Rebecca Cashmore, Sandra Marshall, Jon Arcelus, Paul Robinson, Hubertus Himmerich, Vanessa C. Lawrence, Janet Treasure, Sarah Byford, Sabine Landau, Ulrike Schmidt
A randomized, placebo-controlled, double-blinded trial of MRSA throat carriage treatment, with either standard decolonization alone or in combination with oral clindamycin
Mona Katrine Alberthe Holm, Heidi Karin Meiniche, Michael Pedersen, Helle Brander Eriksen, Henrik Westh, Barbara J. Holzknecht, Mette Damkjær Bartels
Treatment fidelity monitoring, reporting and findings in a complex aphasia intervention trial: a substudy of the Very Early Rehabilitation in SpEech (VERSE) trial
Erin Godecke, Emily Brogan, Natalie Ciccone, Miranda L. Rose, Elizabeth Armstrong, Anne Whitworth, Fiona Ellery, Audrey Holland, Sandy Middleton, Tapan Rai, Graeme J. Hankey, Dominique Cadilhac, Julie Bernhardt
Effect of hospital-at-home vs. traditional brick-and-mortar hospital care in acutely ill adults: study protocol for a pragmatic randomized controlled trial
Xiaoxi Yao, Margaret Paulson, Michael J. Maniaci, Ajani N. Dunn, Chad R. Nelson, Emma M. Behnken, Melissa S. Hart, Lindsey R. Sangaralingham, Shealeigh A. Inselman, Michelle A. Lampman, Shannon M. Dunlay, Sean C. Dowdy, Elizabeth B. Habermann
Qatar Diabetes Mobile Application Trial (QDMAT): an open-label randomised controlled trial to examine the impact of using a mobile application to improve diabetes care in type 2 diabetes mellitus—a study protocol
Noor Suleiman, Meis Alkasem, Zaina Al Amer, Obada Salameh, Noora Al-Thani, Mohammad Khair Hamad, Khaled Baagar, Ibrahem Abdalhakam, Manal Othman, Ragae Dughmosh, Dabia Al-Mohanadi, Ali Al Sanousi, Mohammed Bashir, Odette Chagoury, Shahrad Taheri, Abdul-Badi Abou-Samra
Reducing household air pollution exposure to improve early child growth and development; a randomized control trial protocol for the “Poriborton-Extension: The CHANge trial”
Camille Raynes-Greenow, Sk Masum Billah, Sajia Islam, S. M. Rokonuzzaman, Fahmida Tofail, Elizabeth K. Kirkwood, Ashraful Alam, Ryan Chartier, Tarana E. Ferdous, Shams El Arifeen, Michael J. Dibley, Nusrat Homaira, Alison Hayes, Jonathan Thornburg, Patrick Kelly
Implementation of patient-reported outcomes for symptom management in oncology practice through the SIMPRO research consortium: a protocol for a pragmatic type II hybrid effectiveness-implementation multi-center cluster-randomized stepped wedge trial
Michael J. Hassett, Sandra Wong, Raymond U. Osarogiagbon, Jessica Bian, Don S. Dizon, Hannah Hazard Jenkins, Hajime Uno, Christine Cronin, Deborah Schrag
Effect of negative pressure wound therapy after surgical removal of deep-seated high-malignant soft tissue sarcomas of the extremities and trunk wall—study protocol for a randomized controlled trial
Müjgan Yilmaz, Andrea Thorn, Michala Skovlund Sørensen, Claus Lindkær Jensen, Michael Mørk Petersen
Patient and health practitioner views and experiences of a cancer trial before and during COVID-19: qualitative study
Frances C. Sherratt, Peter Fisher, Amy Mathieson, Mary G. Cherry, Andrew R. Pettitt, Bridget Young
Can the prophylactic administration of tranexamic acid reduce the blood loss after robotic-assisted radical prostatectomy? Robotic Assisted Radical Prostatectomy with tranEXamic acid (RARPEX): study protocol for a randomized controlled trial
M. Balik, J. Kosina, P. Husek, J. Pacovsky, M. Brodak, F. Cecka
Effect of new biological patch in repairing intrauterine adhesion and improving clinical pregnancy outcome in infertile women: study protocol for a randomized controlled trial
Wen-Juan Pang, Qing Zhang, Hai-Xia Ding, Ning-Xia Sun, Wen Li
Using text and charts to provide social norm feedback to general practices with high overall and high broad-spectrum antibiotic prescribing: a series of national randomised controlled trials
Natalie Gold, Anna Sallis, Ayoub Saei, Rohan Arambepola, Robin Watson, Sarah Bowen, Matija Franklin, Tim Chadborn
The influence of skin-to-skin contact on Cortical Activity during Painful procedures in preterm infants in the neonatal intensive care unit (iCAP mini): study protocol for a randomized control trial
Marsha Campbell-Yeo, Britney Benoit, Aaron Newman, Celeste Johnston, Tim Bardouille, Bonnie Stevens, Arlene Jiang
Safety, reactogenicity, and immunogenicity of a 2-dose Ebola vaccine regimen of Ad26.ZEBOV followed by MVA-BN-Filo in healthy adult pregnant women: study protocol for a phase 3 open-label randomized controlled trial
Etienne Karita, Julien Nyombayire, Rosine Ingabire, Amelia Mazzei, Tyronza Sharkey, Jeannine Mukamuyango, Susan Allen, Amanda Tichacek, Rachel Parker, Frances Priddy, Felix Sayinzoga, Sabin Nsanzimana, Cynthia Robinson, Michael Katwere, Dickson Anumendem, Maarten Leyssen, Malinda Schaefer, Kristin M. Wall
Protocol for an attention-matched randomized controlled trial of 2GETHER: a relationship education and HIV prevention program for young male couples
Michael E. Newcomb, Elissa L. Sarno, Emily Bettin, Adam Conway, James Carey, Christopher Garcia, Ricky Hill, Kyle Jozsa, Gregory Swann, Elizabeth L. Addington, Jody D. Ciolino, Kathryn Macapagal, Judith T. Moskowitz, Brian Mustanski, Sarah W. Whitton
Protocol paper: multi-Centre randomised controlled trial evaluating a pre-clinic diabetes assessment and mapped care planning intervention amongst adults with type 1, type 2 or pre-diabetes
Ryan Charles Kelly, Peter Phiri, Hermione Price, Amar Ali, Irene Stratton, Kayleigh Austin, Alice Neave, Katharine Barnard-Kelly
Parasternal After Cardiac Surgery (PACS): a prospective, randomised, double-blinded, placebo-controlled trial study protocol for evaluating a continuous bilateral parasternal block with lidocaine after open cardiac surgery through sternotomy
Mark Larsson, Ulrik Sartipy, Anders Franco-Cereceda, Anders Öwall, Jan Jakobsson
Evaluation of the safety and efficacy of a Fuling-Zexie decoction for people with asymptomatic hyperuricemia: protocol for a prospective, double-blinded, randomized, placebo-controlled clinical trial
Jingyao Yan, Yingyan Zhou, Qiaowen Yang, Jiaqi Wu, Xiaohong He
Bringing rehabilitation home with an e-health platform to treat stroke patients: study protocol of a randomized clinical trial (RGS@home)
Anna Mura, Martina Maier, Belén Rubio Ballester, Javier De la Torre Costa, Judit López-Luque, Axelle Gelineau, Stephane Mandigout, Per Hamid Ghatan, Raffaele Fiorillo, Fabrizio Antenucci, Ton Coolen, Iñigo Chivite, Antonio Callen, Hugo Landais, Olga Irina Gómez, Cristina Melero, Santiago Brandi, Marc Domenech, Jean-Christophe Daviet, Riccardo Zucca, Paul F. M. J. Verschure
Assessing the impact of a novel house design on the incidence of malaria in children in rural Africa: study protocol for a household-cluster randomized controlled superiority trial
Salum Mshamu, Arnold Mmbando, Judith Meta, John Bradley, Thomas Chevalier Bøjstrup, Nicholas P. J. Day, Mavuto Mukaka, Fredros Okumu, Ally Olotu, Christopher Pell, Jacqueline Deen, Jakob Knudsen, Steven W. Lindsay, Lorenz von Seidlein
The Appalachia Mind Health Initiative (AMHI): a pragmatic randomized clinical trial of adjunctive internet-based cognitive behavior therapy for treating major depressive disorder among primary care patients
Robert M. Bossarte, Ronald C. Kessler, Andrew A. Nierenberg, Ambarish Chattopadhyay, Pim Cuijpers, Angel Enrique, Phyllis M. Foxworth, Sarah M. Gildea, Bea Herbeck Belnap, Marc W. Haut, Kari B. Law, William D. Lewis, Howard Liu, Alexander R. Luedtke, Wilfred R. Pigeon, Larry A. Rhodes, Derek Richards, Bruce L. Rollman, Nancy A. Sampson, Cara M. Stokes, John Torous, Tyler D. Webb, Jose R. Zubizarreta
Evaluating the mechanisms and long-term effects of a web-based comprehensive sexual health and media literacy education program for young adults attending community college: study protocol for a three-arm randomized controlled trial
Tracy M. Scull, Christina V. Dodson, Reina Evans-Paulson, Liz C. Reeder, Jacob Geller, Kathryn N. Stump, Janis B. Kupersmidt
Mobile app and digital system for patients after myocardial infarction (afterAMI): study protocol for a randomized controlled trial
Bartosz Krzowski, Michał Peller, Maria Boszko, Paulina Hoffman, Natalia Żurawska, Karolina Jaruga, Kamila Skoczylas, Gabriela Osak, Łukasz Kołtowski, Marcin Grabowski, Grzegorz Opolski, Paweł Balsam
Bilateral upper extremity motor priming (BUMP) plus task-specific training for severe, chronic upper limb hemiparesis: study protocol for a randomized clinical trial
Mary Ellen Stoykov, Olivia M. Biller, Alexandra Wax, Erin King, Jacob M. Schauer, Louis F. Fogg, Daniel M. Corcos
CANreduce-SP—adding psychological support to web-based adherence-focused guided self-help for cannabis users: study protocol for a three-arm randomized control trial
J. I. Mestre-Pintó, F. Fonseca, M. P. Schaub, C. Baumgartner, M. Alias-Ferri, M. Torrens
Tailoring limb length based on total small bowel length in one anastomosis gastric bypass surgery (TAILOR study): study protocol for a randomized controlled trial
Nienke Slagter, Loek J. M. de Heide, Ewoud H. Jutte, Mirjam A. Kaijser, Stefan L. Damen, André P. van Beek, Marloes Emous
Effect of a single-dose denosumab on semen quality in infertile men (the FITMI study): study protocol for a randomized controlled trial
Sam Kafai Yahyavi, Rune Holt, Li Juel Mortensen, Jørgen Holm Petersen, Niels Jørgensen, Anders Juul, Martin Blomberg Jensen
Drugs and convalescent plasma therapy for COVID-19: a survey of the interventional clinical studies in Italy after 1 year of pandemic
Maria Puopolo, Cristina Morciano, Maria Buoncervello, Chiara De Nuccio, Rosa Luisa Potenza, Elena Toschi, Lucia Palmisano
Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)—study protocol for a randomized controlled trial
Susanne G. R. Klotz, Gesche Ketels, Christian A. Behrendt, Hans-Helmut König, Sebastian Kohlmann, Bernd Löwe, Johannes Petersen, Sina Stock, Eik Vettorazzi, Antonia Zapf, Inke Zastrow, Christian Zöllner, Hermann Reichenspurner, Evaldas Girdauskas
Minding the Baby versus usual care: study protocol for a quasi-cluster-randomized controlled study in Denmark of an early interdisciplinary home-visiting intervention for families at increased risk for adversity
Maiken Pontoppidan, Mette Thorsager, Mette Friis-Hansen, Arietta Slade, Lois S. Sadler
Australasian Malignant PLeural Effusion (AMPLE)-3 trial: study protocol for a multi-centre randomised study comparing indwelling pleural catheter (±talc pleurodesis) versus video-assisted thoracoscopic surgery for management of malignant pleural effusion
Deirdre B. Fitzgerald, Calvin Sidhu, Charley Budgeon, Ai Ling Tan, Catherine A. Read, Benjamin C. H. Kwan, Nicola Ann Smith, Edward T. Fysh, Sanjeevan Muruganandan, Tajalli Saghaie, Ranjan Shrestha, Arash Badiei, Phan Nguyen, Andrew Burke, John Goddard, Morgan Windsor, Julie McDonald, Gavin Wright, Kasia Czarnecka, Parthipan Sivakumar, Kazuhiro Yasufuku, David J. Feller-Kopman, Nick A. Maskell, Kevin Murray, Y. C. Gary Lee
Empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia: study protocol for a multicenter, open-label randomized controlled clinical trial
Pablo Rojo, Cinta Moraleda, Alfredo Tagarro, Sara Domínguez-Rodríguez, Lola Madrid Castillo, Luis Manuel Prieto Tato, Aranzazu Sancho López, Lilit Manukyan, Olivier Marcy, Valeriane Leroy, Alessandra Nardone, David Burger, Quique Bassat, Matthew Bates, Raoul Moh, Pui-Ying Iroh Tam, Tisungane Mvalo, Justina Magallhaes, W. Chris Buck, Jahit Sacarlal, Victor Musiime, Chishala Chabala, Hilda Angela Mujuru
The high-volume haemodiafiltration vs high-flux haemodialysis registry trial (H4RT): a multi-centre, unblinded, randomised, parallel-group, superiority study to compare the effectiveness and cost-effectiveness of high-volume haemodiafiltration and high-flux haemodialysis in people with kidney failure on maintenance dialysis using linkage to routine healthcare databases for outcomes
Fergus J. Caskey, Sunita Procter, Stephanie J. MacNeill, Julia Wade, Jodi Taylor, Leila Rooshenas, Yumeng Liu, Ammar Annaw, Karen Alloway, Andrew Davenport, Albert Power, Ken Farrington, Sandip Mitra, David C. Wheeler, Kristian Law, Helen Lewis-White, Yoav Ben-Shlomo, Will Hollingworth, Jenny Donovan, J. Athene Lane
A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial)
Rahel Naef, Miodrag Filipovic, Marie-Madlen Jeitziner, Stefanie von Felten, Judith Safford, Marco Riguzzi, Michael Rufer
Prophylaxis in healthcare workers during a pandemic: a model for a multi-centre international randomised controlled trial using Bayesian analyses
Pepa Bruce, Kate Ainscough, Lee Hatter, Irene Braithwaite, Lindsay R. Berry, Mark Fitzgerald, Thomas Hills, Kathy Brickell, David Cosgrave, Alex Semprini, Susan Morpeth, Scott Berry, Peter Doran, Paul Young, Richard Beasley, Alistair Nichol
Blinding of study statisticians in clinical trials: a qualitative study in UK clinical trials units
Mais Iflaifel, Christopher Partlett, Jennifer Bell, Andrew Cook, Carrol Gamble, Steven Julious, Edmund Juszczak, Louise Linsell, Alan Montgomery, Kirsty Sprange
Getting it wrong most of the time? Comparing trialists’ choice of primary outcome with what patients and health professionals want
Shaun Treweek, Viviane Miyakoda, Dylan Burke, Frances Shiely
Preemptive analgesia for hemorrhoidectomy: study protocol for a prospective, randomized, double-blind trial
Ekaterina Kazachenko, Tatiana Garmanova, Alexander Derinov, Daniil Markaryan, Hanjoo Lee, Sabrina Magbulova, Petr Tsarkov
Effects of robot-assisted therapy on upper limb and cognitive function in patients with stroke: study protocol of a randomized controlled study
Yana Wang, Mingzhu Ye, Yujie Tong, Li Xiong, Xuejiao Wu, Chao Geng, Wen Zhang, Ziqi Dai, Wei Tian, Jifeng Rong
Using mHealth to improve adherence and reduce blood pressure in individuals with hypertension and bipolar disorder (iTAB-CV): study protocol for a 2-stage randomized clinical trial
Jennifer B. Levin, David J. Moore, Colin Depp, Jessica L. Montoya, Farren Briggs, Mahboob Rahman, Kurt C. Stange, Douglas Einstadter, Celeste Weise, Carla Conroy, Joy Yala, Ethan Radatz, Martha Sajatovic
The efficacy and safety of acupuncture combined with language training for motor aphasia after stroke: study protocol for a multicenter randomized sham-controlled trial
Shizhe Deng, Bomo Sang, Boxuan Li, Hai Lu, Lili Zhang, Guang Tian, Ting Hao, Yufeng Zhang, Lei Shi, Kaihang Sun, Te Ba, Feng Li, Ying Kong, Mengni Qin, Jianli Zhang, Xiaofeng Zhao, Zhihong Meng
Correction: Efficacy and cost-effectiveness of therapist-guided internet-delivered behaviour therapy for children and adolescents with Tourette syndrome: study protocol for a single-blind randomised controlled trial
Per Andrén, Lorena Fernández de la Cruz, Kayoko Isomura, Fabian Lenhard, Charlotte L. Hall, E. Bethan Davies, Tara Murphy, Chris Hollis, Filipa Sampaio, Inna Feldman, Matteo Bottai, Eva Serlachius, Erik Andersson, David Mataix-Cols
The Social Competence Promotion Program among Young Adolescents (SCPP-YA) in Chile (“Mi Mejor Plan”) for substance use prevention among early adolescents: study protocol for a randomized controlled trial
Jorge Gaete, Constanza Inzunza, Saray Ramírez, Daniela Valenzuela, Cristian Rojas, Ricardo Araya
Effect of mobile-based cognitive behavior therapy (CBT) on lowering of blood lipid levels in atherosclerotic cardiovascular disease (ASCVD) patients: study protocol for a multicenter, prospective, randomized controlled trial
Xu-Lin Hong, Yi Luan, Hong-Ying Liu, Wen-Bin Zhang
Efficacy of the cognitive functional therapy (CFT) in patients with chronic nonspecific low back pain: a study protocol for a randomized sham-controlled trial
Mariana Romano de Lira, Ney Armando de Mello Meziat-Filho, Gabriela Zuelli Martins Silva, Thaís Cristina Chaves
The effects of polyunsaturated fatty acid (PUFA) administration on the microbiome-gut-brain axis in adolescents with anorexia nervosa (the MiGBAN study): study protocol for a longitudinal, double-blind, randomized, placebo-controlled trial
Lara Keller, Astrid Dempfle, Brigitte Dahmen, Samira Schreiber, Roger A. H. Adan, Nadia Andrea Andreani, Unna N. Danner, Albrecht Eisert, Sergueï Fetissov, Florian Ph. S. Fischmeister, Andreas Karwautz, Kerstin Konrad, Karlijn L. Kooij, Stefanie Trinh, Benny van der Vijgh, Annemarie A. van Elburg, Michael Zeiler, John Baines, Jochen Seitz, Beate Herpertz-Dahlmann
Correction: Prophylaxis in healthcare workers during a pandemic: a model for a multi-centre international randomised controlled trial using Bayesian analyses
Pepa Bruce, Kate Ainscough, Lee Hatter, Irene Braithwaite, Lindsay R. Berry, Mark Fitzgerald, Thomas Hills, Kathy Brickell, David Cosgrave, Alex Semprini, Susan Morpeth, Scott Berry, Peter Doran, Paul Young, Richard Beasley, Alistair Nichol
Correction: Lessons learned from Integrated Management Program Advancing Community Treatment of Atrial Fibrillation (IMPACT-AF): a pragmatic clinical trial of computerized decision support in primary care
Joanna M. Nemis-White, Laura M. Hamilton, Sarah Shaw, James H. MacKillop, Ratika Parkash, Shurjeel H. Choudhri, Antonio Ciaccia, Feng Xie, Lehana Thabane, Jafna L. Cox
Randomized double-blind controlled trial to assess the efficacy of intravenous acetaminophen associated with strong opioids in the treatment of acute pain in adult cancer patients: study protocol
Ofelia Leiva, Joel Castellano, Luz M. Letelier, Luis Rojas, Paola Viviani, Antonio Gonzalez, Pedro Perez-Cruz
Correction: Uniportal and three-portal video-assisted thoracic surgery pulmonary lobectomy for early-stage lung cancer (UNIT trial): study protocol of a single-center randomized trial
Paolo Mendogni, Alessandra Mazzucco, Alessandro Palleschi, Lorenzo Rosso, Ilaria Righi, Rosaria Carrinola, Francesco Damarco, Emilia Privitera, Jacopo Fumagalli, Gianluca Bonitta, Mario Nosotti, Davide Tosi
Correction: Assessing the impact of a novel house design on the incidence of malaria in children in rural Africa: study protocol for a household-cluster randomized controlled superiority trial
Salum Mshamu, Arnold Mmbando, Judith Meta, John Bradley, Thomas Chevalier Bøjstrup, Nicholas P. J. Day, Mavuto Mukaka, Fredros Okumu, Ally Olotu, Christopher Pell, Jacqueline Deen, Jakob Knudsen, Steven W. Lindsay, Lorenz von Seidlein
The effect of sesame oil consumption compared to sunflower oil on lipid profile, blood pressure, and anthropometric indices in women with non-alcoholic fatty liver disease: a randomized double-blind controlled trial
Hamid Vahedi, Masoumeh Atefi, Mohammad Hassan Entezari, Akbar Hassanzadeh
Amitriptyline at low-dose and titrated for irritable bowel syndrome as second-line treatment (The ATLANTIS trial): protocol for a randomised double-blind placebo-controlled trial in primary care
Sarah L. Alderson, Alexandra Wright-Hughes, Alexander C. Ford, Amanda Farrin, Suzanne Hartley, Catherine Fernandez, Christopher Taylor, Pei Loo Ow, Emma Teasdale, Daniel Howdon, Elspeth Guthrie, Robbie Foy, Matthew J. Ridd, Felicity L. Bishop, Delia Muir, Matthew Chaddock, Amy Herbert, Deborah Cooper, Ruth Gibbins, Sonia Newman, Heather Cook, Roberta Longo, Hazel Everitt
Mobile rehabilitation support versus usual care in patients after total hip or knee arthroplasty: study protocol for a randomised controlled trial
Qingling Wang, Sharyn Hunter, Regina Lai-Tong Lee, Xiaofeng Wang, Sally Wai-Chi Chan
Effects of a smartphone app-augmented treatment for children with oppositional defiant disorder / conduct disorder and peer-related aggressive behavior – a pilot study
Anja Görtz-Dorten, Marlin Frank, Anja Fessel, Leonie Hofmann, Manfred Döpfner
A randomized, parallel control and multicenter clinical trial of evidence-based traditional Chinese medicine massage treatment VS External Diclofenac Diethylamine Emulgel for the treatment of knee osteoarthritis
Wang Wen-yue, Xu Ying-peng, Ding Quan-mao, Xie Li-min, Wang De-zhi, Bai Yang, Wang Li-su, Li Yu-bin, Niu Zhi-jun, Ma Yan-xu, Chen Wu-zhong, Bai Li-qun, Liu Yang, Jin Li-kun
A prospective trial to evaluate the clinical efficacy and safety of neoadjuvant chemotherapy with arsenic trioxide and carboplatin in locally advanced cervical cancer: a study protocol for randomized controlled clinical
Ze Yang He, Hai Ying Li, Jiao Yan, Si Jin Li, Dao Cheng Li, Zhong Zhe Liang
Topical sirolimus solution for lingual microcystic lymphatic malformations in children and adults (TOPGUN): study protocol for a multicenter, randomized, assessor-blinded, controlled, stepped-wedge clinical trial
A. Marchand, A. Caille, V. Gissot, B. Giraudeau, C. Lengelle, H. Bourgoin, B. Largeau, S. Leducq, A. Maruani
The antibacterial effect of nanosilver fluoride in relation to caries activity in primary teeth: a protocol for a randomized controlled clinical trial
Nour Ammar, Magda M. El-Tekeya, Sara Essa, Marwa M. Essawy, Samar N. El Achy, Dalia M. Talaat
Comparison of 8 weeks standard treatment (rifampicin plus clarithromycin) vs. 4 weeks standard plus amoxicillin/clavulanate treatment [RC8 vs. RCA4] to shorten Buruli ulcer disease therapy (the BLMs4BU trial): study protocol for a randomized controlled multi-centre trial in Benin
Roch Christian Johnson, Emma Sáez-López, Esaï Sèdjro Anagonou, Godwin Gérard Kpoton, Adjimon Gilbert Ayelo, Ronald Sètondji Gnimavo, Franck Zinsou Mignanwande, Jean-Gabin Houezo, Ghislain Emmanuel Sopoh, Juliet Addo, Lindsay Orford, Georgios Vlasakakis, Nandita Biswas, Felix Calderon, Oscar Della Pasqua, Anna Gine-March, Zaida Herrador, Alfonso Mendoza-Losana, Gabriel Díez, Israel Cruz, Santiago Ramón-García
Generalizability and reach of a randomized controlled trial to improve oral health among home care recipients: comparing participants and nonparticipants at baseline and during follow-up
Jonas Czwikla, Alexandra Herzberg, Sonja Kapp, Stephan Kloep, Heinz Rothgang, Ina Nitschke, Cornelius Haffner, Falk Hoffmann
Implementation, mechanisms of change and contextual factors of a complex intervention to improve interprofessional collaboration and the quality of medical care for nursing home residents: study protocol of the process evaluation of the interprof ACT intervention package
Linda Steyer, Christian Kortkamp, Christiane Müller, Britta Tetzlaff, Nina Fleischmann, Clarissa E. Weber, Martin Scherer, Anja Kühn, Anne-Marei Jarchow, Frederike Lüth, Sascha Köpke, Tim Friede, Hans-Helmut König, Eva Hummers, Indre Maurer, Katrin Balzer
Evaluation of a mobile mammography unit: concepts and randomized cluster trial protocol of a population health intervention research to reduce breast cancer screening inequalities
Elodie Guillaume, Quentin Rollet, Ludivine Launay, Séverine Beuriot, Olivier Dejardin, Annick Notari, Elodie Crevel, Ahmed Benhammouda, Laurent Verzaux, Marie-Christine Quertier, Guy Launoy
The effect of Bushen Culuan Decoction on anovulatory infertile women among 6 different diseases: a study protocol for a randomized, double-blinded, positively controlled, adaptive multicenter clinical trial
Kun Ma, Yun Shi, Junqin He, Xiuxiang Teng, Rongyu Wang, Guohua Wang, Yanan Yu, Yanxia Chen, Linjuan Gong, Yuan Yuan, Huixian Zhang, Bochao Yuan, Chenhui Zhang
Correction: Comparative effectiveness of aerobic exercise versus Yi Jin Jing on ovarian function in young overweight/obese women with polycystic ovary syndrome: study protocol for a randomized controlled trial
Jing Zhao, Antonnette Ketlhoafetse, Xiangyun Liu, Yang Cao
Lateral versus conventional fasciotomy for prevention of lateral femoral cutaneous nerve injury in total hip arthroplasty with direct anterior approach: a study protocol for a dual-center, double-blind, randomized controlled trial
Hiroki Tanabe, Tomonori Baba, Yu Ozaki, Naotake Yanagisawa, Sammy Banno, Taiji Watari, Yasuhiro Homma, Masashi Nagao, Kazuo Kaneko, Muneaki Ishijima
Virtual reality (VR) to reduce anxiety in children in the plaster room: a study protocol for a randomised controlled trial
Lisa van der Water, Max A. Poppelaars, Iris Koenraadt-van Oost, Pieter Boele van Hensbroek, Christiaan J. A. van Bergen
Effects of robotic priming of bilateral arm training, mirror therapy, and impairment-oriented training on sensorimotor and daily functions in patients with chronic stroke: study protocol of a single-blind, randomized controlled trial
Yi-chen Lee, Yi-chun Li, Keh-chung Lin, Grace Yao, Ya-ju Chang, Ya-yun Lee, Chien-ting Liu, Wan-ling Hsu, Yi-hsuan Wu, Ho-ta Chu, Ting-xuan Liu, Yi-ping Yeh, Chieh Chang
Reducing severe fatigue in patients with diffuse glioma: a study protocol for an RCT on the effect of blended cognitive behavioural therapy
Jantine Geertruida Röttgering, Linda Douw, Philip C. de Witt Hamer, Mathilde C. M. Kouwenhoven, Tom Würdinger, Peter M. van de Ven, Louise Sharpe, Hans Knoop, Martin Klein
Proton pump inhibitor in the prevention of upper gastrointestinal mucosal injury associated with dual antiplatelet therapy after coronary artery bypass grafting (DACAB-GI-2): study protocol for a randomized controlled trial
Yunpeng Zhu, Xiaojin Wang, Yi Yang, Lei Liu, Qiang Zhao, Lifen Yu
High-flow nasal cannula oxygen therapy versus noninvasive ventilation for patients with blunt chest trauma: protocol for a randomized controlled trial
Qingcheng Zhu, Bingxia Wang, Yujie Li, Bingyu Ling, Jun Xu, Kui Jin, Ming Sun, Jianjun Zhu, Joseph Walline, Yunyun Wang, Peng Cao, Xiaojuan Guo, Dingyu Tan
A multi-centered trial investigating gestational treatment with ursodeoxycholic acid compared to metformin to reduce effects of diabetes mellitus (GUARD): a randomized controlled trial protocol
Holly Lovell, Alice Mitchell, Caroline Ovadia, Noelia Pitrelli, Annette Briley, Claire Singh, Hanns-Ulrich Marschall, Kennedy Cruickshank, Helen Murphy, Paul Seed, Catherine Williamson
Early oral stepdown antibiotic therapy versus continuing intravenous therapy for uncomplicated Gram-negative bacteraemia (the INVEST trial): study protocol for a multicentre, randomised controlled, open-label, phase III, non-inferiority trial
I. Russel Lee, Steven Y. C. Tong, Joshua S. Davis, David L. Paterson, Sharifah F. Syed-Omar, Kwong Ran Peck, Doo Ryeon Chung, Graham S. Cooke, Eshele Anak Libau, Siti-Nabilah B. A. Rahman, Mihir P. Gandhi, Luming Shi, Shuwei Zheng, Jenna Chaung, Seow Yen Tan, Shirin Kalimuddin, Sophia Archuleta, David C. Lye
Effects of photobiomodulation on re-epithelialization of burn wound: protocol for a randomized controlled trial
Silvana Cristina de Araújo Pereira Venceslau, Júlia Lacet Silva Ferreira, Renata Maria Freire Barros, Ronny Marcos de Morais, Heleodório Honorato dos Santos, Valéria Mayaly Alves de Oliveira, Palloma Rodrigues de Andrade
Stromal vascular fraction-enriched fat grafting as treatment of adherent scars: study design of a non-randomized early phase trial
Linda Vriend, Joris A. van Dongen, Anouk Pijpe, Marianne K. Nieuwenhuis, Sandra J. M. Jongen, Martin C. Harmsen, Paul P. M. van Zuijlen, Berend van der Lei
Manual acupuncture as prophylaxis for migraine without aura: study protocol for a multi-center, randomized, single-blinded trial
Jiao Chen, Siyuan Zhou, Mingsheng Sun, Yanan Wang, Xiaoqin Chen, Taipin Guo, Lu Liu, Jing Luo, Xixiu Ni, Xuguang Yang, Dehua Li, Shan Gao, Zhenxi He, Dingjun Cai, Ling Zhao
Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial
Sarah Seyffert, Salwa Moiz, Matthew Coghlan, Patil Balozian, Jason Nasser, Emilio Abi Rached, Yasser Jamil, Kiran Naqvi, Lori Rawlings, Anthony J. Perkins, Sujuan Gao, J. Downs Hunter III, Sikandar Khan, Annie Heiderscheit, Linda L. Chlan, Babar Khan
Increasing Children’s physical Activity by Policy (CAP) in preschools within the Stockholm region: study protocol for a pragmatic cluster-randomized controlled trial
C. Chen, V. H. Ahlqvist, P. Henriksson, J. H. Migueles, F. Christiansen, M. R. Galanti, D. Berglind
Insecticide-treated eave nets and window screens for malaria control in Chalinze district, Tanzania: a study protocol for a household randomised control trial
Olukayode G. Odufuwa, Sarah Jane Moore, Zawadi Mageni Mboma, Emmanuel Mbuba, Joseph Barnabas Muganga, Jason Moore, Rose Philipo, Mohammed Ally Rashid, Rune Bosselmann, Ole Skovmand, John Bradley
Implant migration and functional outcome of Reverse Shoulder Lateralized Glenosphere Line Extension System: a study protocol for a randomized controlled trial
Marie Louise Jensen, Bo S. Olsen, Marc R. K. Nyring, Müjgan Yilmaz, Michael M. Petersen, Gunnar Flivik, Jeppe V. Rasmussen
A prospective randomised controlled trial of mechanical axis with soft tissue release balancing vs functional alignment with bony resection balancing in total knee replacement—a study using Stryker Mako robotic arm-assisted technology
Simon W. Young, Nina Zeng, Mei Lin Tay, David Fulker, Christina Esposito, Matthew Carter, Ali Bayan, Bill Farrington, Rupert Van Rooyen, Matthew Walker
Evaluate the safety and efficacy of dura sealant patch in reducing cerebrospinal fluid leakage following elective cranial surgery (ENCASE II): study protocol for a randomized, two-arm, multicenter trial
Andrew P. Carlson, Emma M. H. Slot, Tristan P. C. van Doormaal, E. H. J. Voormolen, J. W. Dankbaar, P. Depauw, B. Brouwers, M. R. Germans, E. Baert, J. Vandersteene, C. F. Freyschlag, J. Freyschlag, C. Thomé, F. Zenga, F. Penner, A. Abdulazim, M. Sabel, M. Rapp, T. Beez, M. Zuccarello, E. Sauvageau, K. Abdullah, B. Welch, D. Langer, J. Ellis, A. Dehdashti, J. VanGompel, B. Bendok, K. Chaichana, J. Liu, A. Dogan, M. K. Lim, M. G. Hayden
Effectiveness and cost-effectiveness of text messages with or without endowment incentives for weight management in men with obesity (Game of Stones): study protocol for a randomised controlled trial
Lisa Macaulay, Catriona O’Dolan, Alison Avenell, Paula Carroll, Seonaidh Cotton, Stephan Dombrowski, Andrew Elders, Beatriz Goulao, Cindy Gray, Fiona M. Harris, Kate Hunt, Frank Kee, Graeme MacLennan, Matthew David McDonald, Michelle McKinley, Rebecca Skinner, Claire Torrens, Martin Tod, Katrina Turner, Marjon van der Pol, Pat Hoddinott
Favipiravir and/or nitazoxanide: a randomized, double-blind, placebo-controlled trial of early therapy in COVID-19 in health workers, their household members, and patients treated at IMSS (FANTAZE)
Tania Smith, Carlos Hoyo-Vadillo, Akosua Agyeman Adom, Liliana Favari-Perozzi, Silke Gastine, Hakim-Moulay Dehbi, Beatriz Villegas-Lara, Eduardo Mateos, Yessica Sara Pérez González, Maria D. Navarro-Gualito, Alejandra S. Cruz-Carbajal, Miguel A. Cortes-Vazquez, Carolina Bekker-Méndez, Charmina Aguirre-Alvarado, Gisela Aguirre-Gil, Lucero Delgado-Pastelin, Andrew Owen, David Lowe, Joseph Standing, Jorge Escobedo
NeuroSAFE PROOF: study protocol for a single-blinded, IDEAL stage 3, multi-centre, randomised controlled trial of NeuroSAFE robotic-assisted radical prostatectomy versus standard robotic-assisted radical prostatectomy in men with localized prostate cancer
Eoin Dinneen, Jack Grierson, Ricardo Almeida-Magana, Rosie Clow, Aiman Haider, Clare Allen, Daniel Heffernan-Ho, Alex Freeman, Tim Briggs, Senthil Nathan, Susan Mallett, Chris Brew-Graves, Nicola Muirhead, Norman R. Williams, Elena Pizzo, Raj Persad, Jon Aning, Lyndsey Johnson, Jon Oxley, Neil Oakley, Susan Morgan, Fawzia Tahir, Imran Ahmad, Lorenzo Dutto, Jonathan M. Salmond, Anand Kelkar, John Kelly, Greg Shaw
REACH-ASD: a UK randomised controlled trial of a new post-diagnostic psycho-education and acceptance and commitment therapy programme against treatment-as-usual for improving the mental health and adjustment of caregivers of children recently diagnosed with autism spectrum disorder
Kathy Leadbitter, Richard Smallman, Kirsty James, Gemma Shields, Ceri Ellis, Sophie Langhorne, Louisa Harrison, Latha Hackett, Alison Dunkerley, Leo Kroll, Linda Davies, Richard Emsley, Penny Bee, Jonathan Green, Sofia Ahmed, Hilary Beach, Charlotte Butter, June Gilbert, Caitlin Goldie, Rebekah Howell, Tessa Hutton, Amelia Pearson, Katy Roe, Cameron Sawyer, Amy Van Gils
Evaluation of the effect of perioperative administration of S(+)-ketamine hydrochloride injection for postoperative acute pain in children: study protocol for a prospective, multicenter, randomized, open-label, parallel-group, pragmatic clinical trial
Hong Wang, Chongyang Duan, Jianmin Zhang, Shuangquan Qu, Ying Sun, Lizhi Zhou, Lujia Yang, Chen Lan, Weidong Mi, Pingyan Chen
Rationale and methods of the Antioxidant and NMDA receptor blocker Weans Anoxic brain damage of KorEa OHCA patients (AWAKE) trial
Jin-Ho Choi, Byeong Jo Chun, Seok Ran Yeom, Sung Phil Chung, Young Hwan Lee, Yun-Hee Kim, Ji Sung Lee, Jin Hwan Lee, Hwan Goo Lee, Jing Yu Jin, Chun San An, Byoung Joo Gwag
A randomized wait-list controlled trial to investigate the role of cognitive mechanisms in parenting interventions on mothers with substance use disorder
Alessio Porreca, Alessandra Simonelli, Pietro De Carli, Lavinia Barone, Bianca Filippi, Paola Rigo, Marinus H. van IJzendoorn, Marian J. Bakermans-Kranenburg
Study protocol for a multi-center RCT testing a group-based parenting intervention tailored to mothers with borderline personality disorder against a waiting control group (ProChild*-SP1)
Charlotte Rosenbach, Nina Heinrichs, Robert Kumsta, Silvia Schneider, Babette Renneberg
Supporting families to achieve a healthy weight development for their child with overweight/obesity using the STARKIDS intervention: study protocol for a cluster-randomized controlled trial
Katrin Ziser, Florian Junne, Anne Herschbach, Peter Martus, Johann Jacoby, Felicitas Stuber, Zahra Rahmani Azad, Isabelle Mack, Alisa Weiland, Inga Krauß, Constanze Greule, Gorden Sudeck, Lydia Kastner, Guido Zurstiege, Andreas Hoell, Wolfgang Bethge, Torben Sammet, Olaf Schliesing, Stephan Zipfel, Stefan Ehehalt, Katrin E. Giel
Vitiligo International Task force for an Agreed List of core data (VITAL): study protocol of a vitiligo core outcome set (COS) and contextual factors for clinical trials, registries, and clinical practice
Nanja van Geel, Iltefat H. Hamzavi, Amit G. Pandya, Albert Wolkerstorfer, Julien Seneschal, Amit Garg, Phyllis Spuls, Caroline B. Terwee, Sue Mallett, Reinhart Speeckaert, Jean Marie Meurant, Viktoria Eleftheriadou, Khaled Ezzedine
Internet videoconferencing delivered cognitive behavior therapy for generalized anxiety disorder: protocol for a randomized controlled trial
Vesna Trenoska Basile, Toby Newton-John, Bethany M. Wootton
Effect of adding a positive memories’ module in a trauma-focused cognitive-behavioural treatment for female survivors of intimate partner violence: trial protocol
M. Crespo, A. Miguel-Alvaro, C. Hornillos, S. Sánchez-Ferrer, A. A. Antón
Correction: Assessment of clinical effect and treatment quality of immediate-release carvedilol-IR versus SLOW release carvedilol-SR in Heart Failure patients (SLOW-HF): study protocol for a randomized controlled trial
Dong-Ju Choi, Chan Soon Park, Jin Joo Park, Hae-Young Lee, Seok-Min Kang, Byung-Su Yoo, Eun-Seok Jeon, Seok Keun Hong, Joon-Han Shin, Myung-A Kim, Dae-Gyun Park, Eung-Ju Kim, Soon-Jun Hong, Seok Yeon Kim, Jae-Joong Kim
AMAZONE: prevention of persistent pain after breast cancer treatment by online cognitive behavioral therapy—study protocol of a randomized controlled multicenter trial
Anne Lukas, Maurice Theunissen, Dianne de Korte-de Boer, Sander van Kuijk, Lotte Van Noyen, Walter Magerl, Werner Mess, Wolfgang Buhre, Madelon Peters
The APPLE Tree programme: Active Prevention in People at risk of dementia through Lifestyle, bEhaviour change and Technology to build REsiliEnce—randomised controlled trial
M. Poppe, L. Duffy, N. L. Marchant, J. A. Barber, R. Hunter, N. Bass, A. M. Minihane, K. Walters, P. Higgs, P. Rapaport, I. A. Lang, S. Morgan-Trimmer, J. Huntley, Z. Walker, H. Brodaty, H. C. Kales, K. Ritchie, A. Burton, J. Wenborn, A. Betz, C. Cooper
The e-mental health treatment in Stockholm myocardial infarction with non-obstructive coronaries or Takotsubo syndrome study (E-SMINC): a study protocol for a randomised controlled trial
Erik M. G. Olsson, Fredrika Norlund, Elisabet Rondung, Sophia M. Humphries, Claes Held, Patrik Lyngå, Jonas Spaak, Örjan Sundin, Runa Sundelin, Philip Leissner, Lena Kövamees, Per Tornvall
Effect of an individualized versus standard blood pressure management during mechanical thrombectomy for anterior ischemic stroke: the DETERMINE randomized controlled trial
Benjamin Maïer, Benjamin Gory, Russell Chabanne, Benoît Tavernier, Baptiste Balanca, Gérard Audibert, Laurie-Anne Thion, Morgan Le Guen, Thomas Geeraerts, Lionel Calviere, Vincent Degos, Bertrand Lapergue, Sebastien Richard, Azeddine Djarallah, Ornellia Mophawe, Perrine Boursin, Chloé Le Cossec, Raphael Blanc, Michel Piotin, Mikael Mazighi, Etienne Gayat, Benjamin Maïer, Simon Escalard, François Delvoye, Solène Hebert, Hocine Redjem, Stanislas Smajda, Jean-Philippe Desilles, Raphael Blanc, Michel Piotin, Mikael Mazighi, Amélie Yavchitz, Chloé Le Cossec, Ornellia Mophawe, Azedine Djarallah, Perrine Boursin, Laurie-Anne Thion, Abdenour Amarouche, Anoushee Shaffii, Audrey Fogang, Aurore Marcou, Elisabeth Ferri, Fanny Le Garrec, Ines Da Costa, Jean-Marie Moures, Jean-Michel Devys, Malika Omarjee, Marie-Claude Dubois, Marie-Claire Nghe-Mann, Matthieu Dorison, Mélanie Sénéchal, Pascal Le Bigot, Nouria Belhadj-Tahar, Severine Gras, Simon Clariot, Stéphane Merat, Sylvie Froucht-Hirsch, Yasmine Ait Yahia, Pierre Seners, Candice Sabben, Bertrand Lapergue, Morgan Le Guen, Julien Rousset, Thomas Geeraerts, Christophe Cognard, Jean-Marc Olivot, Lionel Calviere, Maxime Pommier, Edouard Naboulsi, Marc Begard, Camille Boissy, Thibaud Cammas, Bernard Cosserant, Romain Grobost, Adrien Guyot, Katia Levrier, Pierre-Antoine Pioche, Ricardo Moreno, Abderahim Zerroug, Elie Lteif, Emmanuel Chabert, Anna Ferrier, Aurélie Masgrau, Baptiste Balanca, Lionel Bapteste, Baptiste Bouchier, Claudio Di Roio, Charles-Antoine Lak, Anisoara Gemanar, Romain Carrillon, Carole Bodonian, Benjamin Gory, Serge Bracard, René Anxionnat, Marc Braun, Anne-Laure Derelle, Liang Liao, François Zhu, Emmanuelle Schmitt, Sophie Planel, Sébastien Richard, Lisa Humbertjean, Gioia Mione, Jean-Christophe Lacour, Marian Douarinou, Gérard Audibert, Marcela Voicu, Lionel Alb, Marie Reitter, Madalina Brezeanu, Agnès Masson, Adriana Tabarna, Iona Podar, Pauline Bourst, Valérie Georges, Sarah Guy, Fatiha Bechiri, Benoît Tavernier, Gabriela Julean, Pierre Boussemart, Sidi Hamza Roudies, Dominique Envain, Pierre Appourchaux, Julien Martin, Victor Lestrade, Lucie Della Schiava, Nicolas Bricout, Erine Prévost, Julie Bellet, Etienne Gayat, Mikael Mazighi, Vincent Degos, Dupont Julie, Frédéric Clarençon
Ketamine for acute pain after trauma: the KAPT randomized controlled trial
Thaddeus J. Puzio, James Klugh, Michael W. Wandling, Charles Green, Julius Balogh, Samuel J. Prater, Christopher T. Stephens, Paulina B. Sergot, Charles E. Wade, Lillian S. Kao, John A. Harvin
Efficacy and safety of progressively reducing biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis in persistent remission: a study protocol for a non-inferiority randomized, controlled, single-blind trial
Shangwen Lei, Zijia Li, Xiaoli Zhang, Shuhong Zhou
A longitudinal assessment of trial protocols approved by research ethics committees: The Adherance to SPIrit REcommendations in the UK (ASPIRE-UK) study
Benjamin Speich, Ayodele Odutayo, Nicholas Peckham, Alexander Ooms, Jamie R. Stokes, Ramon Saccilotto, Dmitry Gryaznov, Belinda von Niederhäusern, Bethan Copsey, Douglas G. Altman, Matthias Briel, Sally Hopewell
Improving the management of chronic pain, opioid use, and opioid use disorder in older adults: study protocol for I-COPE study
Ainur Kagarmanova, Heather Sparkman, Neda Laiteerapong, Katherine Thompson, Linda Rosul, Danielle Lazar, Erin Staab, Wen Wan, Amanda Kass, Mim Ari
Impact of probiotic supplementation on exercise endurance among non-elite athletes: study protocol for a randomized, placebo-controlled, double-blind, clinical trial
Caitlin E. McDermott, Heather K. Vincent, Anne E. Mathews, Brunella Gonzalez Cautela, Mariana Sandoval, Annie Tremblay, Bobbi Langkamp-Henken
Protocol for a multi-center randomized controlled trial to evaluate the benefits of exercise incentives and corticosteroid injections in osteoarthritis of the knee (MOVE-OK)
William Leach, Caleigh Doherty, Marianna Olave, Bryant R. England, Katherine Wysham, Gail Kerr, Mercedes Quinones, Alexis Ogdie, Dan White, Tuhina Neogi, Carla R. Scanzello, Joshua F. Baker
Effectiveness of acupuncture at acupoint BL1 (Jingming) in comparison with artificial tears for moderate to severe dry eye disease: a randomized controlled trial
Xue Zhang, Bo Zhang, Siyang Peng, Guoliang Zhang, Jumei Ma, Wenzeng Zhu
The 2nd European Carotid Surgery Trial (ECST-2): rationale and protocol for a randomised clinical trial comparing immediate revascularisation versus optimised medical therapy alone in patients with symptomatic and asymptomatic carotid stenosis at low to intermediate risk of stroke
Suk Fun Cheng, Twan J. van Velzen, John Gregson, Toby Richards, Hans Rolf Jäger, Robert Simister, M. Eline Kooi, Gert J. de Borst, Francesca B. Pizzini, Paul J. Nederkoorn, Martin M. Brown, Leo H. Bonati
Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial—the ROSEBUD study
M. B. Syrjälä, L. Bennet, P. C. Dempsey, E. Fharm, M. Hellgren, S. Jansson, S. Nilsson, M. Nordendahl, O. Rolandsson, K. Rådholm, A. Ugarph-Morawski, P. Wändell, P. Wennberg
Effectiveness of a training intervention to improve the management of vertigo in primary care: a multicentre cluster-randomised trial, VERTAP
Jenniffer Elizabeth Pérez Patiño, José Lluís Ballvé Moreno, Yolanda Rando Matos, Jesús Almeda Ortega, Oriol Cunillera Puértolas, Ricard Carrillo Muñoz, Iván Villar Balboa, Xavier González Compta, Olga Lucía Arias Agudelo, Sebastiá Calero Muñoz, Vanessa Monforte Rodríguez, Anna Navarro Cortes, Eva Peguero Rodríguez
Underrepresentation of ethnic minorities in hypertension research—a survey of enablers and barriers among South Asian and African communities in Glasgow
Stefanie Lip, Georgia Dempster, Sahil Jain, Katriona Brooksbank, Nazim Ghouri, Linsay McCallum, Sandosh Padmanabhan
Design of a multinational randomized controlled trial to assess the effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life: the EFFECT study
Anouk E. Hiensch, Evelyn M. Monninkhof, Martina E. Schmidt, Eva M. Zopf, Kate A. Bolam, Neil K. Aaronson, Jon Belloso, Wilhelm Bloch, Dorothea Clauss, Johanna Depenbusch, Milena Lachowicz, Mireia Pelaez, Helene Rundqvist, Elzbieta Senkus, Martijn M. Stuiver, Mark Trevaskis, Ander Urruticoechea, Friederike Rosenberger, Elsken van der Wall, G. Ardine de Wit, Philipp Zimmer, Yvonne Wengström, Karen Steindorf, Anne M. May
An intervention to reduce stigma and improve management of depression, risk of suicide/self-harm and other significant emotional or medically unexplained complaints among adolescents living in urban slums: protocol for the ARTEMIS project
Sandhya Kanaka Yatirajula, Sudha Kallakuri, Srilatha Paslawar, Ankita Mukherjee, Amritendu Bhattacharya, Susmita Chatterjee, Rajesh Sagar, Ashok Kumar, Heidi Lempp, Usha Raman, Renu Singh, Beverley Essue, Laurent Billot, David Peiris, Robyn Norton, Graham Thornicroft, Pallab K. Maulik
Comparing the effect of a lactation-specific relaxation and visualisation intervention versus standard care on lactation and mental health outcomes in mothers of very premature infants (the EXPRESS trial): study protocol for a multi-centre, unmasked, randomised, parallel-group trial
Ilana Levene, Jennifer L. Bell, Christina Cole, Kayleigh Stanbury, Frances O’Brien, Mary Fewtrell, Maria A. Quigley
Interdisciplinary intervention (GAIN) for adults with post-concussion symptoms: a study protocol for a stepped-wedge cluster randomised trial
Erhard Trillingsgaard Næss-Schmidt, Mille Møller Thastum, Henriette Holm Stabel, Lene Odgaard, Asger Roer Pedersen, Charlotte Ulrikka Rask, Noah D. Silverberg, Andreas Schröder, Jørgen Feldbæk Nielsen
A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs)
Joanne Coyle, Amy Rogers, Rachel Copland, Giorgia De Paoli, Thomas M. MacDonald, Isla S. Mackenzie
Short-term aerobic exercise for depression in acute geriatric psychiatry: study protocol for a randomized controlled trial
Laura Elani Schulte, Tim Fleiner, Rieke Trumpf, Daria Wirtz, Thiemo Schnorr, Wiebren Zijlstra, Peter Haussermann
Comparing anterior gastropexy to no anterior gastropexy for paraesophageal hernia repair: a study protocol for a randomized control trial
K. E. Blake, S. J. Zolin, C. Tu, K. F. Baier, L. R. Beffa, D. Alaedeen, D. M. Krpata, A. S. Prabhu, M. J. Rosen, C. C. Petro
Activity tracker-based intervention to increase physical activity in patients with type 2 diabetes and healthy individuals: study protocol for a randomized controlled trial
M. Mähs, J. S. Pithan, I. Bergmann, L. Gabrys, J. Graf, A. Hölzemann, K. Van Laerhoven, S. Otto-Hagemann, M. L. Popescu, L. Schwermann, B. Wenz, I. Pahmeier, A. Teti
Evaluation of the PhunkyFoods intervention on food literacy and cooking skills of children aged 7–9 years: a cluster randomised controlled trial in Yorkshire Primary Schools UK
Karen L. Vaughan, Janet E. Cade, Marion M. Hetherington, Jennie E. Cockroft, Mirjam M. Heinen, Holly Rippin, Charlotte E. L. Evans
Study protocol for a randomized trial on timely delivery versus expectant management in late preterm small for gestational age pregnancies with an abnormal umbilicocerebral ratio (UCR): the DRIGITAT study
M. Smies, S. E. Damhuis, R. G. Duijnhoven, A. G. Leemhuis, S. J. Gordijn, W. Ganzevoort
Effect of vibration associated with cryotherapy on vaccine-related pain and anxiety levels in adults: study protocol for a randomized clinical trial
Elaine Aparecida da Cunha Lima, Luana Vieira Toledo, Marisa Dibbern Lopes Correia, Daniela de Almeida Pereira, Renata Oliveira Caetano, Thaís Bitencourt Faria, Luciene Muniz Braga
Pasos Hacia La Salud II: study protocol for a randomized controlled trial of a theory- and technology-enhanced physical activity intervention for Latina women, compared to the original intervention
Andrea S. Mendoza-Vasconez, Tanya Benitez, Shira Dunsiger, Kim M. Gans, Sheri J. Hartman, Sarah E. Linke, Britta A. Larsen, Dorothy Pekmezi, Bess H. Marcus
Impact of rapid molecular testing on diagnosis, treatment and management of community-acquired pneumonia in Norway: a pragmatic randomised controlled trial (CAPNOR)
Sondre Serigstad, Christian Ritz, Daniel Faurholt-Jepsen, Dagfinn Markussen, Marit H. Ebbesen, Øyvind Kommedal, Rune O. Bjørneklett, Lars Heggelund, Tristan W. Clark, Cornelis H. van Werkhoven, Siri T. Knoop, Elling Ulvestad, Harleen M. S. Grewal, R. Bjørneklett, T. W. Clark, M. Ebbesen, D. Faurholt-Jepsen, H. M. S. Grewal, L. Heggelund, S. T. Knoop, Ø. Kommedal, D. Markussen, P. Ravn, C. Ritz, S. Serigstad, E. Ulvestad, C. H. Van Werkhoven
Noradrenergic Add-on Therapy with Extended-Release Guanfacine in Alzheimer’s Disease (NorAD): study protocol for a randomised clinical trial and COVID-19 amendments
Karen Hoang, Hilary Watt, Mara Golemme, Richard J. Perry, Craig Ritchie, Danielle Wilson, James Pickett, Chris Fox, Robert Howard, Paresh A. Malhotra
GeneXpert or chest-X-ray or tuberculin skin testing for household contact assessment (GXT): protocol for a cluster-randomized trial
Anete Trajman, Menonli Adjobimey, Mayara Lisboa Bastos, Chantal Valiquette, Olivia Oxlade, Federica Fregonese, Dissou Affolabi, Marcelo Cordeiro-Santos, Renato T. Stein, Andrea Benedetti, Dick Menzies
Development of a novel intervention to improve sleep and pain in patients undergoing total knee replacement
K. Whale, R. Gooberman-Hill
Safety of low-intensity repetitive transcranial magneTic brAin stimUlation foR people living with mUltiple Sclerosis (TAURUS): study protocol for a randomised controlled trial
Kalina Makowiecki, Natasha Stevens, Carlie L. Cullen, Amin Zarghami, Phuong Tram Nguyen, Lewis Johnson, Jennifer Rodger, Mark R. Hinder, Michael Barnett, Kaylene M. Young, Bruce V. Taylor
Safety and effectiveness of delivering mass drug administration for helminths through the seasonal malaria chemoprevention platform among Senegalese children: study protocol for a randomised controlled trial
Muhammed O. Afolabi, Doudou Sow, Jean Louis A. Ndiaye, Brian Greenwood
Proper understanding of recurrent stress urinary incontinence treatment in women (PURSUIT): a randomised controlled trial of endoscopic and surgical treatment
L. Clark, B. Fitzgerald, S. Noble, S. MacNeill, S. Paramasivan, N. Cotterill, H. Hashim, S. Jha, P. Toozs-Hobson, T. Greenwell, N. Thiruchelvam, W. Agur, A. White, V. Garner, M. Cobos-Arrivabene, C. Clement, M. Cochrane, Y. Liu, A. L. Lewis, J. Taylor, J. A. Lane, M. J. Drake, C. Pope
Evaluation of prediction effect of perfusion index for supraclavicular brachial plexus block in children: protocol for a randomized trial
Jinxu Wang, Lingli Deng, Aijun Xu
Randomised controlled trial comparing the clinical and cost-effectiveness of various washout policies versus no washout policy in preventing catheter associated complications in adults living with long-term catheters: study protocol for the CATHETER II study
Mohamed Abdel-fattah, Diana Johnson, Lynda Constable, Ruth Thomas, Seonaidh Cotton, Sheela Tripathee, David Cooper, Sue Boran, Konstantinos Dimitropoulos, Suzanne Evans, Paraskeve Granitsiotis, Hashim Hashim, Mary Kilonzo, James Larcombe, Paul Little, Sara MacLennan, Peter Murchie, Phyo Kyaw Myint, James N’Dow, John Norrie, Muhammad Imran Omar, Catherine Paterson, Graham Scotland, Nikesh Thiruchelvam, Graeme MacLennan
The effects of synbiotic and/or vitamin D supplementation on gut-muscle axis in overweight and obese women: a study protocol for a double-blind, randomized, placebo-controlled trial
Sanaz Jamshidi, Seyed Jalil Masoumi, Behnaz Abiri, Mohammadreza Vafa
Transplantation of mesenchymal stem cells for prevention of acute myocardial infarction induced heart failure: study protocol of a phase III randomized clinical trial (Prevent-TAHA8)
Armin Attar, Ahmad Monabati, Mohammad Montaseri, Massoud Vosough, Seyed Ali Hosseini, Javad Kojouri, Alireza Abdi-Ardekani, Peyman Izadpanah, Negar Azarpira, Gholamreza Pouladfar, Mani Ramzi
Telehealth high-intensity interval exercise and cardiometabolic health in spinal cord injury
Jacob Adams, Byron Lai, James Rimmer, Danielle Powell, Ceren Yarar-Fisher, Robert A. Oster, Gordon Fisher
A randomized controlled trial of customized adherence enhancement (CAE-E): study protocol for a hybrid effectiveness-implementation project
Jennifer B. Levin, Farren Briggs, Carol Blixen, Mark Bauer, Douglas Einstadter, Jeffrey M. Albert, Celeste Weise, Nicole Woods, Edna Fuentes-Casiano, Kristin A. Cassidy, Julie Rentsch, Kaylee Sarna, Martha Sajatovic
Tuberculosis (TB) Aftermath: study protocol for a hybrid type I effectiveness-implementation non-inferiority randomized trial in India comparing two active case finding (ACF) strategies among individuals treated for TB and their household contacts
Samyra R. Cox, Abhay Kadam, Sachin Atre, Akshay N. Gupte, Hojoon Sohn, Nikhil Gupte, Trupti Sawant, Vishal Mhadeshwar, Ryan Thompson, Emily Kendall, Christopher Hoffmann, Nishi Suryavanshi, Deanna Kerrigan, Srikanth Tripathy, Arjunlal Kakrani, Madhusudan S. Barthwal, Vidya Mave, Jonathan E. Golub, Sunil Ambike, Jayshri Jagtap, Pallavi Kadam, Shankar Jadhav, Anita Mahajan, Yogesh Bhosale, Vaibhavi Bodhe, Gautami Walunj, Sachin Rathod, Akshay Bhalchim
Atorvastatin for reduction of 28-day mortality in hospitalized COVID-19 patients: study protocol for a randomized, double-blinded, placebo-controlled, clinical trial
Moataz Maher Emara, Neamat Hamdy Elsawy, Kholoud M. Abdelaaty, Amal Salah Elhamaky, Naglaa Hamdi Eltahan
The effects of Rosa foetida extract along with self-care education on primary dysmenorrhea: study protocol for a randomized clinical trial
Fatemeh Shabani, Shabnam Omidvar, Parvin Sajadi Kaboudi, Hajar Pasha, Soraya Khafri, Hossein Najafzadehvarzi, Fatemeh Nasiri Amiri, Mahbobeh Faramarzi, Zinatossadat Bouzari
Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial
Leslie W. Young, Songthip Ounpraseuth, Stephanie L. Merhar, Alan E. Simon, Abhik Das, Rachel G. Greenberg, Rosemary D. Higgins, Jeannette Lee, Brenda B. Poindexter, P. Brian Smith, Michele Walsh, Jessica Snowden, Lori A. Devlin
Influence of digital media in the oral health education of mother-child pairs: study protocol of a parallel double-blind randomized clinical trial
Yuri Jivago Silva Ribeiro, Luanna Gonçalves Ferreira, Paulo Nelson-Filho, Maya Fernanda Manfrin Arnez, Francisco Wanderley Garcia Paula-Silva
Attractive targeted sugar bait phase III trials in Kenya, Mali, and Zambia
Thomas P. Eisele, Immo Kleinschmidt, Sophie Sarrassat, Feiko terKuile, John Miller, Javan Chanda, Kafula Silumbe, Aaron Samuels, Julia Janssen, Caroline Ogwang, John Bradley, Erica Orange, Josh Yukich, Ruth Ashton, Irene Kyomuhangi, Angela F. Harris, Seydou Doumbia, Mahamoudou Toure, Mohamed Moumine, Silas Majambere, Monicah Mirai Mburu, Gift Mwaanga, Limonty Simubali, Edgar Simulundu, Adam Bennett, Laurence Slutsker, Gunter Muller, Eric Ochomo, John Gimnig, Paul C. D. Johnson, Joseph Wagman, Megan Littrell
Dual thrombolytic therapy with mutant pro-urokinase and small bolus alteplase for ischemic stroke (DUMAS): study protocol for a multicenter randomized controlled phase II trial
Nadinda A. M. van der Ende, Bob Roozenbeek, Lucas E. M. Smagge, Sven P. R. Luijten, Leo A. M. Aerden, Petra Kraayeveld, Ido R. van den Wijngaard, Geert J. Lycklama à Nijeholt, Heleen M. den Hertog, H. Zwenneke Flach, Alexis C. Wallace, Victor Gurewich, Gregory J. del Zoppo, William J. Meurer, Hester F. Lingsma, Aad van der Lugt, Diederik W. J. Dippel, Diederik Dippel, Aad van der Lugt, Nadinda van der Ende, Bob Roozenbeek, Moniek de Maat, Leo Aerden, Ido van den Wijngaard, Heleen den Hertog, Petra Kraayeveld, Geert Lycklama a Nijeholt, Zwenneke Flach, Michael Hill, Jeremy Rempel, Ann Lowe, Hester Lingsma, Daan Nieboer, Gregory del Zoppo, Dingeman Rijken, Adam Cohen, Victor Gurewich, Aad van der Lugt, Lucas Smagge, Martin Sterrenberg, Naziha El Ghannouti, Debby Priem, Monique Batenburg, Eva Ponjee, Rieke Eilander, Joke de Meris, Tamara Dofferhoff-Vermeulen, Sanne den Hartog, Stijn Kremer, Leontien Heiligers, Angela Lansbergen-Engel
Effectiveness of the online Acceptance and Commitment Therapy intervention “Embrace Pain” for cancer survivors with chronic painful chemotherapy-induced peripheral neuropathy: study protocol for a randomized controlled trial
Daniëlle L. van de Graaf, Floortje Mols, Hester R. Trompetter, Marije L. van der Lee, Karlein M. G. Schreurs, Elin Børøsund, Lise Solberg Nes, Tom Smeets
Resistance training and clinical status in patients with postdischarge symptoms after COVID-19: protocol for a randomized controlled crossover trial “The EXER-COVID Crossover Study”
Robinson Ramírez-Vélez, Julio Oteiza, Juan Manuel Casas Fernández de Tejerina, Nora García-Alonso, Gaizka Legarra-Gorgoñon, Sergio Oscoz-Ochandorena, Hugo Arasanz, Yesenia García-Alonso, María Correa-Rodríguez, Mikel Izquierdo
Optimising recruitment in clinical trials for progressive multiple sclerosis: observational analysis from the MS-SMART and MS-STAT2 randomised controlled trials
Thomas Williams, Sarah Alexander, James Blackstone, Floriana De Angelis, Nevin John, Anisha Doshi, Judy Beveridge, Marie Braisher, Emma Gray, Jeremy Chataway
Successes and lessons learned in database development for national multi-site cancer care delivery research trials: the Alliance for Clinical Trials in Oncology experience
David Zahrieh, Shauna L. Hillman, Angelina D. Tan, Jennifer L. Frank, Travis Dockter, Bobbi Jo Meyers, Cassie L. Cherevko, Elizabeth S. Peil, Shaylene McCue, Oudom Kour, Heather J. Gunn, Heather B. Neuman, George J. Chang, Electra D. Paskett, Sumithra J. Mandrekar, Amylou C. Dueck
Antibiotic prophylaxis for percutaneous renal biopsy: study protocol for a prospective randomized trial
Kensei Yahata, Akihiro Yoshimoto, Chiharu Kinoshita, Koichi Seta, Tatsuo Tsukamoto, Motoko Yanagita, Hiroaki Hata, Naoki Sakane
Effectiveness of promotion and support for physical activity maintenance post total hip arthroplasty—study protocol for a pragmatic, assessor-blinded, randomized controlled trial (the PANORAMA trial)
Theresa Bieler, S. Peter Magnusson, Volkert Siersma, Mie Rinaldo, Morten Torrild Schmiegelow, Torben Beck, Anne-Mette Krifa, Birgitte Hougs Kjær, Henrik Palm, Julie Midtgaard
Study protocol for a parallel-group randomized controlled multi-center trial evaluating the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence (SENS-U trial)
L. L. de Wall, A. J. Nieuwhof-Leppink, E. H. M. van de Wetering, E. Leijn, M. Trompetter, L. M. O. de Kort, W. F. Feitz, R. Schappin
Evaluation of the recovery after heart surgery following preoperative supplementation with a combination of beta-hydroxy-beta-methylbutyrate, l-arginine, and l-glutamine: a double-blind randomized placebo-controlled clinical trial
Mona Norouzi, Azadeh Nadjarzadeh, Majid Maleki, Sayyed Saeid Khayyatzadeh, Saeid Hosseini, Mehdi Yaseri, Hamed Fattahi
Effectiveness of repetitive transcranial magnetic stimulation against poststroke urinary incontinence: a study protocol for a randomized controlled trial
Wei Jiang, Wen Tang, Yunling Song, Yali Feng, Yuesan Zhou, Lang Li, Botao Tan
Study protocol and methods for Easing Pelvic Pain Interventions Clinical Research Program (EPPIC): a randomized clinical trial of brief, low-intensity, transdiagnostic cognitive behavioral therapy vs education/support for urologic chronic pelvic pain syndrome (UCPPS)
Jeffrey M. Lackner, James Jaccard, Brian M. Quigley, Tova S. Ablove, Teresa L. Danforth, Rebecca S. Firth, Gregory D. Gudleski, Susan S. Krasner, Christopher D. Radziwon, Alison M. Vargovich, J. Quentin Clemens, Bruce D. Naliboff
Open hemorrhoidectomy under local anesthesia versus saddle block in western Uganda: a study protocol for a prospective equivalence randomized, double-blind controlled trial
Franck Katembo Sikakulya, Robinson Ssebuufu, Xaviour Francis Okedi, Moris Baluku, Herman Lule, Patrick Kyamanywa
Fostering shared decision-making about prostate cancer screening among African American men patients and their primary care providers: a randomized behavioral clinical trial
Margarita Echeverri, Kyazia Felder, David Anderson, Elora Apantaku, Patrick Leung, Clare Hoff, Princess Dennar
A novel GnRH antagonist protocol based on LH levels versus traditional flexible GnRH antagonist protocol in PCOS patients undergoing in vitro fertilization: study protocol for a randomized controlled, non-inferiority trial
Shan Liu, Ya-su Lv, Shuo Han, Minghui Liu, Shuai Ma, Haiying Ren, Yuan Li
An online parenting intervention to prevent affective disorders in high-risk adolescents: the PIPA trial protocol
C. Connor, M. B. H. Yap, J. Warwick, M. Birchwood, N De Valliere, J. Madan, G. A. Melvin, E. Padfield, P. Patterson, S. Petrou, K. Raynes, S. Stewart-Brown, A. Thompson
Protocol for an automated, pragmatic, embedded, adaptive randomised controlled trial: behavioural economics-informed mobile phone-based reminder messages to improve clinic attendance in a Botswanan school-based vision screening programme
Luke N Allen, Bakgaki Ratshaa, David Macleod, Nigel Bolster, Matthew Burton, Min Kim, Andrew Bastawrous, Ari Ho-Foster, Hannah Chroston, Oathokwa Nkomazana
Study protocol for a pragmatic cluster RCT on the effect and cost-effectiveness of Everyday Life Rehabilitation versus treatment as usual for persons with severe psychiatric disability living in sheltered or supported housing facilities
Maria Lindström, Lars Lindholm, Per Liv
Face Your Fears: Virtual reality-based cognitive behavioral therapy (VR-CBT) versus standard CBT for paranoid ideations in patients with schizophrenia spectrum disorders: a randomized clinical trial
U. N. Jeppesen, A. S. Due, L. Mariegaard, A. Pinkham, M. Vos, W. Veling, M. Nordentoft, L. B. Glenthøj
Improving diabetic patients’ adherence to treatment and prevention of cardiovascular disease (Office Guidelines Applied to Practice—IMPACT Study)—a cluster randomized controlled effectiveness trial
Adesuwa Olomu, Karen Kelly-Blake, William Hart-Davidson, Joseph Gardiner, Zhehui Luo, Michele Heisler, Margaret Holmes-Rovner
Prevention and early treatment of the long-term physical effects of COVID-19 in adults: design of a randomised controlled trial of resistance exercise—CISCO-21
A. Morrow, Stuart R. Gray, H. K. Bayes, R. Sykes, E. McGarry, D. Anderson, D. Boiskin, C. Burke, J. G. F. Cleland, C. Goodyear, T. Ibbotson, C. C. Lang, McConnachie, F. Mair, K. Mangion, M. Patel, N. Sattar, D. Taggart, R. Taylor, S. Dawkes, C. Berry
Awakening the control of the ankle dorsiflexors in the post-stroke hemiplegic subject to improve walking activity and social participation: the WAKE (Walking Ankle isoKinetic Exercise) randomised, controlled trial
Béatrice Ferry, Maxence Compagnat, Jules Yonneau, Laurent Bensoussan, Geoffroy Moucheboeuf, François Muller, Bertrand Laborde, Anne Jossart, Romain David, Julien Magne, Loïc Marais, Jean-Christophe Daviet
SHIFTPLAN: a randomized controlled trial investigating the effects of a multimodal shift-work intervention on drivers’ fatigue, sleep, health, and performance parameters.
Inge Declercq, Filip Van Den Eede, Ella Roelant, Johan Verbraecken
Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)
Karl Trygve Druckrey-Fiskaaen, Einar Furulund, Jan Tore Daltveit, Jørn Henrik Vold, Torgeir Gilje Lid, Tesfaye Madebo, Lars Thore Fadnes, Vibeke Bråthen Buljovcic, Trude Fondenes, Per Gundersen, Siv-Elin Leirvåg Carlsen, Mette Hegland Nordbotn, Marianne Cook Pierron, Christine Sundal, Jørn Henrik Vold, Maren Borsheim Bergsaker, Eivin Dahl, Tone Lise Eielsen, Torhild Fiskå, Eirik Holder, Tine Selmer Cruickshank, Ewa Joanna Wilk
Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings
Jamie S. Ostroff, Donna R. Shelley, Lou-Anne Chichester, Jennifer C. King, Yuelin Li, Elizabeth Schofield, Andrew Ciupek, Angela Criswell, Rashmi Acharya, Smita C. Banerjee, Elena B. Elkin, Kathleen Lynch, Bryan J. Weiner, Irene Orlow, Chloé M. Martin, Sharon V. Chan, Victoria Frederico, Phillip Camille, Susan Holland, Jessica Kenney
Integrated traditional Chinese medicine intervention for delaying HIV morbidity: study protocol for a multicentre randomised controlled trial
Xue Ding, Pengfei Meng, Xiuxia Ma, Weifeng Cui, Liangping Li, Xiyuan Song, Jiangrong Wang, Chengjie Ma, Xin Chen, Liran Xu
Treatment shortening of drug-sensitive pulmonary tuberculosis using high-dose rifampicin for 3 months after culture conversion (Hi-DoRi-3): a study protocol for an open-label randomized clinical trial
Nakwon Kwak, Doosoo Jeon, Youngmok Park, Young Ae Kang, Kyung Jong Kim, Young Ran Kim, Byoung Soo Kwon, Yong-Soo Kwon, Hyung-Jun Kim, Jae Ho Lee, Ji Yeon Lee, Jung-Kyu Lee, Jeongha Mok, Minkyoung Cheon, Jiwon Park, Seokyung Hahn, Jae-Joon Yim
Post-operative rehabilitation using a digital healthcare system in patients who had undergone rotator cuff repair: protocol for a single-center randomized controlled trial
Won Kee Chang, Jong In Lee, Ji Hye Hwang, Jae-Young Lim
Timing of transcranial direct current stimulation (tDCS) combined with speech and language therapy (SLT) for aphasia: study protocol for a randomized controlled trial
Sameer A. Ashaie, Samantha Engel, Leora R. Cherney
HORNBILL: a phase I/IIa trial examining the safety, tolerability and early response of BI 764524 in patients with diabetic retinopathy and diabetic macular ischaemia—rationale, study design and protocol
Victor Chong, Quan Dong Nguyen, Yasir Sepah, Andrea Giani, Elizabeth Pearce
The effect of continuing versus withholding angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers on mortality and major adverse cardiovascular events in hypertensive patients undergoing elective non-cardiac surgery: study protocol for a multi-centric open-label randomised controlled trial
Satyajeet Misra, Satyen Parida, Raj Sahajanandan, Bikram Kishore Behera, Muthapillai Senthilnathan, Ramamani Mariappan, Tony Thomson Chandy
Lessons from the COVID-19 pandemic and recent developments on the communication of clinical trials, publishing practices, and research integrity: in conversation with Dr. David Moher
Daeria O. Lawson, Michael K. Wang, Kevin Kim, Rachel Eikelboom, Myanca Rodrigues, Daniela Trapsa, Lehana Thabane, David Moher
Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice
Shoba Dawson, Katie Banister, Katie Biggs, Seonaidh Cotton, Declan Devane, Heidi Gardner, Katie Gillies, Gosala Gopalakrishnan, Talia Isaacs, Kamlesh Khunti, Alistair Nichol, Adwoa Parker, Amy M. Russell, Victoria Shepherd, Frances Shiely, Gillian Shorter, Bella Starling, Hywel Williams, Andrew Willis, Miles D. Witham, Shaun Treweek
Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence
Karen L. Margolis, A. Lauren Crain, Beverly B. Green, Patrick J. O’Connor, Leif I. Solberg, MarySue Beran, Anna R. Bergdall, Pamala A. Pawloski, Jeanette Y. Ziegenfuss, Meghan M. JaKa, Deepika Appana, Rashmi Sharma, Amy J. Kodet, Nicole K. Trower, Daniel J. Rehrauer, Zeke McKinney, Christine K. Norton, Patricia Haugen, Jeffrey P. Anderson, Benjamin F. Crabtree, Sarah K. Norman, JoAnn M. Sperl-Hillen
Access to unpublished protocols and statistical analysis plans of randomised trials
David Campbell, Cassandra McDonald, Suzie Cro, Vipul Jairath, Brennan C. Kahan
The CORE-KDT study: a mixed methods protocol to establish core outcomes for refractory childhood epilepsy treated with ketogenic diet therapy
Jennifer H. Carroll, J. Helen Cross, Mary Hickson, Emma Williams, Valerie Aldridge, Avril Collinson
Efficacy and safety of Dengyinnaotong Capsule in patients with Cognitive impairment caused by cerebral Small Vessel Disease: study protocol of a multicenter, randomized, open-label, controlled trial (De-CSVD trial)
Yan-Xia Li, Jin-Cun Li, Min Tian, Mao-Yong Zheng, Li-Ping Zhang, Jin-Lu Zhang, Feng Yu, Yi-Zhao Li, Qing-Hua Zhang
Clinical and cost-effectiveness of paramedic administered fascia iliaca compartment block for emergency hip fracture (RAPID 2)—protocol for an individually randomised parallel-group trial
Mark Kingston, Jenna Jones, Sarah Black, Bridie Evans, Simon Ford, Theresa Foster, Steve Goodacre, Marie-Louise Jones, Sian Jones, Leigh Keen, Mirella Longo, Ronan A. Lyons, Ian Pallister, Nigel Rees, Aloysius Niroshan Siriwardena, Alan Watkins, Julia Williams, Helen Wilson, Helen Snooks
Shoulder-specific rehabilitation combined with aerobic exercises versus solely shoulder-specific rehabilitation in patients with type 2 diabetes mellitus: study protocol for a randomized controlled superiority trial
Fernanda A. P. Habechian, Mauricio E. Flores Quezada, Ann M. Cools, Birgitte Hougs Kjaer, Rodrigo I. Cuevas Cid, Gisele G. Zanca
uSing rolE-substitutioN In care homes to improve ORal health (SENIOR): a study protocol
Gerald McKenna, Georgios Tsakos, Sinead Watson, Alison Jenkins, Patricia Masterson Algar, Rachel Evans, Sarah R. Baker, Ivor G. Chestnutt, Craig J. Smith, Ciaran O’Neill, Zoe Hoare, Lynne Williams, Vicki Jones, Michael Donaldson, Anup Karki, Caroline Lappin, Kirstie Moons, Fiona Sandom, Mary Wimbury, Lorraine Morgan, Karen Shepherd, Paul Brocklehurst
ImpACT+, a coping intervention to improve clinical outcomes for women living with HIV and sexual trauma in South Africa: study protocol for a randomized controlled trial
K. J. Sikkema, S. Rabie, A. King, M. H. Watt, M. I. Mulawa, L. S. Andersen, P. A. Wilson, A. Marais, E. Ndwandwa, S. Majokweni, C. Orrell, J. A. Joska
Adaptive interventions to optimise the mobile phone-based smoking cessation support: study protocol for a sequential, multiple assignment, randomised trial (SMART)
Sheng Zhi Zhao, Xue Weng, Tzu Tsun Luk, Yongda Wu, Derek Yee Tak Cheung, William Ho Cheung Li, Henry Tong, Vienna Lai, Tai Hing Lam, Man Ping Wang
HIAYA CHAT study protocol: a randomized controlled trial of a health insurance education intervention for newly diagnosed adolescent and young adult cancer patients
Karely Mann, Austin R. Waters, Elyse R. Park, Giselle K. Perez, Perla L. Vaca Lopez, Heydon K. Kaddas, Echo L. Warner, Nicole Ray, Tomoko Tsukamoto, Karlie Allen, Ben Haaland, Douglas B. Fair, Mark A. Lewis, Anne C. Kirchhoff
Identifying disrupted biological factors and patient-tailored interventions for chronic fatigue in adolescents and young adults with Q-Fever Fatigue Syndrome, Chronic Fatigue Syndrome and Juvenile Idiopathic Arthritis (QFS-study): study protocol for a randomized controlled trial with single-subject experimental case series design
Anouk Vroegindeweij, Joost F. Swart, Jan Houtveen, Niels Eijkelkamp, Elise M. van de Putte, Nico M. Wulffraat, Sanne L. Nijhof
EvaLuation of early CRRT and beta-blocker InTervention in patients with ECMO (ELITE) trial: study protocol for a 2 × 2 partial factorial randomized controlled trial
Xiaofang Wang, Hong Wang, Xin Du, Zhiyan Wang, Chenglong Li, Craig S. Anderson, Jinying Zhang, Xiaotong Hou, Jianzeng Dong
Principles and recommendations for incorporating estimands into clinical study protocol templates
Helle Lynggaard, James Bell, Christian Lösch, Amel Besseghir, Khadija Rantell, Volker Schoder, Vivian Lanius
Sleep optimization to improve glycemic control in adults with type 1 diabetes: study protocol for a randomized controlled parallel intervention trial
Pamela Martyn-Nemeth, Jennifer Duffecy, Laurie Quinn, Sirimon Reutrakul, Alana D. Steffen, Larisa Burke, Margaret H. Clark Withington, Ghada Abu Irsheed, Rose Perez, Minsun Park, Adam Saleh, Dan Mihailescu, Kelly Glazer Baron
Goal-directed therapy based on rScO2 monitoring in elderly patients with one-lung ventilation: a randomized trial on perioperative inflammation and postoperative delirium
Jing-yu Wang, Ming Li, Pei Wang, Ping Fang
Potential of FX06 to prevent disease progression in hospitalized non-intubated COVID-19 patients — the randomized, EU-wide, placebo-controlled, phase II study design of IXION
Jan Kloka, Benjamin Friedrichson, Stephanie Dauth, Ann Christina Foldenauer, Anita Bulczak-Schadendorf, Maria J. G. T. Vehreschild, Francisco Maio Matos, Antoni Riera-Mestre, Antoinette D. I. van Asselt, Edoardo De Robertis, Vilma Traskaite Juskeviciene, Patrick Meybohm, Dana Tomescu, Karine Lacombe, Coen D. A. Stehouwer, Kai Zacharowski, Oliver Old, Markus Ketomaeki, Lea Grebe, Patrick Booms, Simone Lindau, Sebastian Zinn, Isabel Maushagen, Timo Wolf, Christoph Stephan, Cathy Weynants, Sylvia Daamen, Petra Wülfroth, Thomas Steiner, Marinus van Hulst, Peter Kranke, Sebastian Hottenrott, Tobias Schlesinger, Benedikt Schmid, Daniel Röder, Eva Kranke, Tobias Haas, Philipp Schlesinger, Magdalena Sitter, Davide Valeri, Raquel Torres Iglesias, José María Mora-Luján, Adriana Iriarte, Pau Cerdà, Neringa Vaguliene, Andrius Macas, Jolanta Litviniene, Kristina Balne, Catarina Monteiro, Inês Antunes Ferreira, Patrícia Couceiro, Pedro Soares, Sofia Beirão, Yasmine Abi Aad, Thibault Chiarabini, Mihai Popescu, C. J. H. van der Kallen
The effect of Tribulus terrestris supplementation on inflammation, oxidative stress, and performance of recreational runners: study protocol for a randomized placebo-controlled trial
Marzieh Nejati, Parvin Dehghan, Mostafa Khani, Parvin Sarbakhsh
The effect of osteotomy technique (flat-cut vs wedge-cut Weil) on pain relief and complication incidence following surgical treatment for metatarsalgia in a private metropolitan clinic: protocol for a randomised controlled trial
Manaal Fatima, Nalan Ektas, Corey Scholes, Michael Symes, Andrew Wines
Notes from an epicenter: navigating behavioral clinical trials on autism spectrum disorder amid the COVID-19 pandemic in the Bronx
Alaina S. Berruti, Roseann C. Schaaf, Emily A. Jones, Elizabeth Ridgway, Rachel L. Dumont, Benjamin Leiby, Catherine Sancimino, Misung Yi, Sophie Molholm
Evaluation of an adaptive, multimodal intervention to reduce postoperative infections following cesarean delivery in Ethiopia: study protocol of the CLEAN-CS cluster-randomized stepped wedge interventional trial
Tihitena Negussie Mammo, Mekdes Daba Feyssa, Sara Taye Haile, Tesfaneh Fikre, Matiyas Asrat Shiferaw, Habtamu Woldeamanuel, Fikremelekot Temesgen, Natnael Gebeyehu, Nichole Starr, Katie Fernandez, Natalie Henrich, Senait Bitew Alemu, Kate Miller, Thomas G. Weiser
G-CuP: the effect of a forced oral glucose intake on alcohol craving and mesolimbic cue reactivity in alcohol dependence—study protocol of a randomized, double-blind, placebo-controlled crossover study
Lea Wetzel, Madeleine Pourbaix, Alisa Riegler, Anna-Maria Pfeifer, Iris Reinhard, Sabine Hoffmann, Sabine Vollstädt-Klein, Falk Kiefer, Wolfgang Sommer, Jan Malte Bumb, Patrick Bach, Anne Koopmann
Cerebral mechanism of Tuina analgesia in management of knee osteoarthritis using multimodal MRI: study protocol for a randomised controlled trial
Guangxin Guo, Yazhuo Kong, Qingguang Zhu, Zhiwei Wu, Shuaipan Zhang, Wuquan Sun, Yanbin Cheng, Min Fang
Effect of acupuncture with donepezil based on syndrome differentiation on cognitive function in patients with mild-to-moderate Alzheimer’s disease: a study protocol for a multicenter randomized controlled trial
Qin-Hui Fu, Jian Pei, Hou-guang Zhou, Tao Wang, Yi-jun Zhan, Lin Tao, Jia Xu, Qian Zhou, Liao-yao Wang
Early essential newborn care for cesarean section newborns in China: study protocol for a multi-centered randomized controlled trial
Xueyin Wang, Xiaosong Zhang, Howard Lawrence Sobel, Zhao Li, Juan Juan, Huixia Yang
Extended-release pharmacotherapy for opioid use disorder (EXPO): protocol for an open-label randomised controlled trial of the effectiveness and cost-effectiveness of injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone
John Marsden, Mike Kelleher, Zoë Hoare, Dyfrig Hughes, Jatinder Bisla, Angela Cape, Fiona Cowden, Edward Day, Jonathan Dewhurst, Rachel Evans, Andrea Hearn, Joanna Kelly, Natalie Lowry, Martin McCusker, Caroline Murphy, Robert Murray, Tracey Myton, Sophie Quarshie, Gemma Scott, Sophie Turner, Rob Vanderwaal, April Wareham, Eilish Gilvarry, Luke Mitcheson
Effectiveness and adherence to closed face shields in the prevention of COVID-19 transmission: a non-inferiority randomized controlled trial in a middle-income setting (COVPROSHIELD)
Andrea Ramirez Varela, Alejandro Pacheco Gurruchaga, Silvia Restrepo Restrepo, Juan David Martin, Yessica Daniela Campaz Landazabal, Guillermo Tamayo-Cabeza, Sandra Contreras-Arrieta, Yuldor Caballero-Díaz, Luis Jorge Hernandez Florez, John Mario González, Juan Carlos Santos-Barbosa, José David Pinzón, Juan José Yepes-Nuñez, Rachid Laajaj, Giancarlo Buitrago Gutierrez, Martha Vives Florez, Janner Fuentes Castillo, Gianni Quinche Vargas, Andres Casas, Antonio Medina, Eduardo Behrentz, Yenny Paola Rueda Guevara, Daniela Rodriguez Sanchez, Marcela Guevara-Suarez, Marylin Hidalgo, Paola Betancourt
Effect of high-flow nasal therapy on patient-centred outcomes in patients at high risk of postoperative pulmonary complications after cardiac surgery: a statistical analysis plan for NOTACS, a multicentre adaptive randomised controlled trial
Sarah N. Dawson, Yi-Da Chiu, Andrew A. Klein, Melissa Earwaker, Sofia S. Villar
Efficacy of manual acupuncture, electro-acupuncture, and warm acupuncture for knee osteoarthritis: study protocol for a randomized controlled trial
Yiniu Chang, Nan Wu, Zhenhua Zhang, Zhaoyang Zhang, Binbin Ren, Feilai Liu, Xiaolei Song, Mingli Wu, Xiaodong Feng, Shuai Yin
Effectiveness of an expert assessment and individualised treatment compared with a minimal home-based exercise program in women with late-term shoulder impairments after primary breast cancer surgery: study protocol for a randomised controlled trial
Kim Michéle Feder, Hans Bjarke Rahr, Marianne Djernes Lautrup, Heidi Klakk Egebæk, Robin Christensen, Kim Gordon Ingwersen
Chopstick technique versus cross technique in LESS hysterectomy (CCLEH study): a prospective randomized controlled trial
Yuya Dou, Li Deng, Shuai Tang, Yuanyang Yao, Xiaolong Liang, Qunying Hu, Yanzhou Wang
Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial
Alexander Hoenning, Johannes Lemcke, Sergej Rot, Dirk Stengel, Berthold Hoppe, Kristina Zappel, Patrick Schuss, Sven Mutze, Leonie Goelz
AZTEC—azithromycin therapy for prevention of chronic lung disease of prematurity: a statistical analysis plan for clinical outcomes
Tin Man Mandy Lau, John Lowe, Timothy Pickles, Kerenza Hood, Sailesh Kotecha, David Gillespie
Study protocol: Evaluation of the ‘Flavour School’ sensory food education programme: a cluster-randomised controlled trial in UK primary school children, aged 4–7 years, to determine impact on confidence and curiosity in tasting vegetables and fruit
Nicholas M. Wilkinson, Srimathi Kannan, Harish Ganguri, Marion M. Hetherington, Charlotte E. L. Evans
A double-blind clinical trial to compare the efficacy and safety of a multiple amino acid-based ORS with the standard WHO-ORS in the management of non-cholera acute watery diarrhea in infants and young children: “VS002A” trial protocol
Rina Das, Rukaeya Amin Sobi, Al-Afroza Sultana, Baitun Nahar, Pradip Kumar Bardhan, Laura Luke, Olivier Fontaine, Tahmeed Ahmed
The effects of breathing exercises and inhaler training in patients with COPD on the severity of dyspnea and life quality: a randomized controlled trial
Yasemin Ceyhan, Pınar Tekinsoy Kartin
Study protocol of brief intervention using gene polymorphism information for excessive drinking among Japanese college students and adults aged 20–30 years: a randomized controlled trial
Yukiko Owaki, Hisashi Yoshimoto, Go Saito, Takahiro Goto, Satoshi Kushio, Akihiro Nakamura, Yusuke Togo, Kazumasa Mori, Hideki Hokazono
The efficacy and tolerability of sports drink versus water in bowel preparations: a randomised controlled study
Zhixin Zhang, Hui Gao, Xin Yuan, Cenqin Liu, Zhenfei Bao, Siyi Yu, Haofen Xie, Weihong Wang, Jiarong Xie, Lei Xu
Factors associated with reporting of the Prevention of Falls Network Europe (ProFaNE) core outcome set domains in randomized trials on falls in older people: a citation analysis and correlational study
Alexandra M. B. Korall, Dawn Steliga, Sarah E. Lamb, Stephen R. Lord, Rasheda Rabbani, Kathryn M. Sibley
Effect of acupuncture for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized clinical trial
Ling-Yu Qi, Jing-Wen Yang, Shi-Yan Yan, Yan-Fen She, Hui Hu, Ying Li, Li-Li Chi, Bang-Qi Wu, Jian-Feng Tu, Li-Qiong Wang, Cun-Zhi Liu
Evaluating a couple communication skills training (CCST) intervention for advanced cancer: study protocol for a randomized controlled trial
Laura S. Porter, Katherine Ramos, Donald H. Baucom, Karen Steinhauser, Alaattin Erkanli, Timothy J. Strauman, S. Yousuf Zafar, Devon K. Check, Karena Leo, Evan Liu, Francis J. Keefe
E-Mental-Health aftercare for children and adolescents after partial or full inpatient psychiatric hospitalization: study protocol of the randomized controlled DigiPuR trial
Marlene Finkbeiner, Jan Kühnhausen, Johanna Schmid, Annette Conzelmann, Ute Dürrwächter, Lena-Marie Wahl, Augustin Kelava, Caterina Gawrilow, Tobias J. Renner
Efficacy and safety of ivermectin in the treatment of mild to moderate COVID-19 infection: a randomized, double-blind, placebo-controlled trial
Anan Manomaipiboon, Kittisak Pholtawornkulchai, Sujaree Poopipatpab, Swangjit Suraamornkul, Jakravoot Maneerit, Wiroj Ruksakul, Uraporn Phumisantiphong, Thananda Trakarnvanich
Research protocol: Cervical Arthroplasty Cost Effectiveness Study (CACES): economic evaluation of anterior cervical discectomy with arthroplasty (ACDA) versus anterior cervical discectomy with fusion (ACDF) in the surgical treatment of cervical degenerative disc disease — a randomized controlled trial
Valérie N. E. Schuermans, Anouk Y. J. M. Smeets, Toon F. M. Boselie, Math J. J. M. Candel, Inez Curfs, Silvia M. A. A. Evers, Henk Van Santbrink
Evaluation of the patient-accompanying app “alley ortho companion” for patients with osteoarthritis of the knee and hip: study protocol for a randomized controlled multi-center trial
André Strahl, Heiko Graichen, Holger Haas, Robert Hube, Carsten Perka, Tim Rolvien, Jan Hubert
Preoperative smoking cessation program in patients undergoing intermediate to high-risk surgery: a randomized, single-blinded, controlled, superiority trial
Christian D. Fankhauser, Andres Affentranger, Beatrice Cortonesi, Urs Jeker, Markus Gass, Fabrizio Minervini, Georg Jung, Corina Christmann, Christine Brambs, Milo A. Puhan, Ulrike Held
Comparison of weight loss induced by daily caloric restriction versus intermittent fasting (DRIFT) in individuals with obesity: study protocol for a 52-week randomized clinical trial
Danielle M. Ostendorf, Ann E. Caldwell, Adnin Zaman, Zhaoxing Pan, Kristen Bing, Liza T. Wayland, Seth A. Creasy, Daniel H. Bessesen, Paul MacLean, Edward L. Melanson, Victoria A. Catenacci
Control of Line Complications with KiteLock (CLiCK) in the critical care unit: study protocol for a multi-center, cluster-randomized, double-blinded, crossover trial investigating the effect of a novel locking fluid on central line complications in the critical care population
Marlena Ornowska, Hubert Wong, Yongdong Ouyang, Anish Mitra, Aaron White, Sue Willems, Jessica Wittmann, Steven Reynolds
Impact of propofol versus sevoflurane on the incidence of postoperative delirium in elderly patients after spine surgery: study protocol of a randomized controlled trial
Ji-hua Wang, Meng Lv, Hai-xia Zhang, Yang Gao, Ting-ting Chen, Tian-tian Wan, Yue-lan Wang
Effectiveness of the internet-based Unified Protocol transdiagnostic intervention for the treatment of depression, anxiety and related disorders in a primary care setting: a randomized controlled trial
Ladislav Timulak, Derek Richards, Louise Bhandal-Griffin, Patrick Healy, Juliana Azevedo, Graham Connon, Elaine Martin, Aoife Kearney, Conor O’Kelly, Angel Enrique, Nora Eilert, Sorcha O’Brien, Siobhan Harty, Alberto González-Robles, Elizabeth H. Eustis, David H. Barlow, Todd J. Farchione
Placental growth fActor Repeat sampling for Reduction of adverse perinatal Outcomes in women with suspecTed pre-eclampsia: study protocol for a randomised controlled trial (PARROT-2)
Alice Hurrell, Jenie Sparkes, Kate Duhig, Paul T. Seed, Jenny Myers, Cheryl Battersby, Katherine Clark, Marcus Green, Rachael M. Hunter, Andrew H. Shennan, Lucy C. Chappell, Louise Webster
Preoperative oral diazepam for intraoperative blood pressure stabilisation in hypertensive patients undergoing vitrectomy under retrobulbar nerve block anaesthesia: study protocol for a randomised controlled trial
Tianwei Qian, Qiaoyun Gong, Chong Chen, Xia Wu, Lin Xue, Ying Fan, Weijun Wang, Zhihua Zhang, Hui Cao, Xun Xu
Educational interventions to improve women’s preventive behavior of sexually transmitted infections (STIs): study protocol for a randomized controlled trial
Afsaneh Karami Juyani, Fatemeh Zarei, Shamsodin Niknami, Alireza Haydarni, Raziyeh Maasoumi
Efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial
Shu-guang Yang, Xue-qing Yu, Jian-sheng Li, Yang Xie, Wei Zhang, Chengjun Ban, Jihong Feng, Lei Wu, Xuechao Lu, Limin Zhao, Yong Meng, Miao Zhou, Yong He, Weixian Luo
Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR)
Gert Klug, Sebastian Reinstadler, Felix Troger, Magdalena Holzknecht, Martin Reindl, Christina Tiller, Ivan Lechner, Priscilla Fink, Mathias Pamminger, Christian Kremser, Hanno Ulmer, Axel Bauer, Bernhard Metzler, Agnes Mayr
A community-based peer-support group intervention “Paths to EvERyday life” (PEER) added to service as usual for adults with vulnerability to mental health difficulties – a study protocol for a randomized controlled trial
Chalotte Heinsvig Poulsen, Cecilie Høgh Egmose, Bea Kolbe Ebersbach, Carsten Hjorthøj, Lene Falgaard Eplov
Enhancing COVID Rehabilitation with Technology (ECORT): protocol for an open-label, single-site randomized controlled trial evaluating the effectiveness of electronic case management for individuals with persistent COVID-19 symptoms
Simon Hatcher, Joel Werier, Nicole E. Edgar, James Booth, D. William J. Cameron, Vicente Corrales-Medina, Daniel Corsi, Juthaporn Cowan, Pierre Giguère, Mark Kaluzienski, Shawn Marshall, Tiago Mestre, Bryce Mulligan, Heather Orpana, Amanda Pontefract, Darlene Stafford, Kednapa Thavorn, Guy Trudel
Efficacy and safety of EXOWALK® on electromechanical-assisted gait training: study protocol for randomized controlled trial
Chi-Yeon Lim, Mun Jung Ko, Jin Won Lee, Soo Kyung Bok, Nam-Jong Paik, Yeon Gyo Nam, Bum Sun Kwon
Opening the Conversation: study protocol for a Phase III trial to evaluate a couple-based intervention to reduce reproductive and sexual distress among young adult breast and gynecologic cancer survivor couples
Jessica R. Gorman, Karen S. Lyons, S. Marie Harvey, Chiara Acquati, John M. Salsman, Deborah A. Kashy, Julia H. Drizin, Ellie Smith, Lisa M. Flexner, Brandon Hayes-Lattin, Jennifer B. Reese
A personalised intervention programme aimed at improving adherence to oral antidiabetic and/or antihypertensive medication in people with type 2 diabetes mellitus, the INTENSE study: study protocol for a randomised controlled trial
Marlous Langendoen-Gort, Hiyam Al-Jabr, Jacqueline G. Hugtenburg, Femke Rutters, Maartje de Wit, Debi Bhattacharya, Ameen Abu-Hanna, Andrew Farmer, Petra J. M. Elders
Effectiveness of rib fixation compared to pain medication alone on pain control in patients with uncomplicated rib fractures: study protocol of a pragmatic multicenter randomized controlled trial—the PAROS study (Pain After Rib OSteosynthesis)
Jean Yaniss Perentes, Michel Christodoulou, Etienne Abdelnour-Berchtold, Wolfram Karenovics, Angèle Gayet-Ageron, Michel Gonzalez, Thorsten Krueger, Frédéric Triponez, Philippe Terrier, Benoît Bédat
Effects of physical training on physical and functional fitness, physical activity level, endothelial function, hemodynamic variables, bone metabolism, and quality of life of post-bariatric patients: study protocol for a randomized controlled trial
Karynne Grutter Lopes, Maria das Graças Coelho de Souza, Michelle da Costa Tavares Bezerra, Lucas Miranda Bessa, Paulo Farinatti, Eliete Bouskela, Miguel Madeira, Luiz Guilherme Kraemer-Aguiar
Effectiveness of a Mindful Compassion Care Program in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized controlled trial
Luca Bodini, Chiara Bonetto, Simone Cheli, Lidia Del Piccolo, Michela Rimondini, Alberto Rossi, Angela Carta, Stefano Porru, Francesco Amaddeo, Antonio Lasalvia
Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic
Julie C. Reid, Alex Molloy, Geoff Strong, Laurel Kelly, Heather O’Grady, Deborah Cook, Patrick M. Archambault, Ian Ball, Sue Berney, Karen E. A. Burns, Frederick D’Aragon, Erick Duan, Shane W. English, François Lamontagne, Amy M. Pastva, Bram Rochwerg, Andrew J. E. Seely, Karim Serri, Jennifer L. Y. Tsang, Avelino C. Verceles, Brenda Reeve, Alison Fox-Robichaud, John Muscedere, Margaret Herridge, Lehana Thabane, Michelle E. Kho
The efficacy of micropulse laser combined with ranibizumab in diabetic macular edema treatment: study protocol for a randomized controlled trial
Xuejing Mi, Xiaoya Gu, Xiaobing Yu
Infliximab in the treatment of patients with severe COVID-19 (INFLIXCOVID): protocol for a randomised, controlled, multicentre, open-label phase II clinical study
Sina M. Coldewey, Charles Neu, Frank Bloos, Philipp Baumbach, Ulrike Schumacher, Michael Bauer, Philipp Reuken, Andreas Stallmach
Clinical efficacy of mandibular complete dentures with a resilient liner: study protocol for a multicenter randomized controlled trial
Katsuhiko Kimoto, Suguru Kimoto, Noriyuki Hoshi, Yusuke Sato, Yoshikazu Yoneyama, Jun Takebe, Tetsuo Ichikawa, Hiroshi Murata, Masahiro Nishimura, Shunsuke Minakuchi, Yasuhiko Kawai
IMI2-PainCare-BioPain-RCT2 protocol: a randomized, double-blind, placebo-controlled, crossover, multicenter trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by non-invasive neurophysiological measurements of human spinal cord and brainstem activity
Caterina Leone, Giulia Di Stefano, Giuseppe Di Pietro, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C. Chapman, Nanna Brix Finnerup, Luis Garcia-Larrea, Tom Li, Marcus Goetz, André Mouraux, Bernhard Pelz, Esther Pogatzki-Zahn, Andreas Schilder, Erik Schnetter, Karin Schubart, Irene Tracey, Inaki F. Troconiz, Hans Van Niel, Jose Miguel Vela Hernandez, Katy Vincent, Jan Vollert, Vishvarani Wanigasekera, Matthias Wittayer, Keith G. Phillips, Andrea Truini, Rolf-Detlef Treede
A drug free solution for improving the quality of life of fibromyalgia patients (Fibrepik): study protocol of a multicenter, randomized, controlled effectiveness trial
Emilie Chipon, Jean-Luc Bosson, Laure Minier, Anne Dumolard, Antoine Vilotitch, David Crouzier, Caroline Maindet
Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18–36 months
E. Bailin Xie, Kaeley M. Simpson, Kristin A. Reynolds, Ryan J. Giuliano, Jennifer L. P. Protudjer, Melanie Soderstrom, Shannon Sauer-Zavala, Gerald F. Giesbrecht, Catherine Lebel, Anna L. Mackinnon, Charlie Rioux, Lara Penner-Goeke, Makayla Freeman, Marlee R. Salisbury, Lianne Tomfohr-Madsen, Leslie E. Roos
Theoretical and practical development of the TOPSY self-management intervention for women who use a vaginal pessary for pelvic organ prolapse
Lucy Dwyer, Carol Bugge, Suzanne Hagen, Kirsteen Goodman, Wael Agur, Melanie Dembinsky, Margaret Graham, Karen Guerrero, Christine Hemming, Aethele Khunda, Doreen McClurg, Lynn Melone, Ranee Thakar, Rohna Kearney
Efficacy and safety of guselkumab in biologic-naïve patients with active axial psoriatic arthritis: study protocol for STAR, a phase 4, randomized, double-blinded, placebo-controlled trial
Dafna D. Gladman, Philip J. Mease, Paul Bird, Enrique R. Soriano, Soumya D. Chakravarty, May Shawi, Stephen Xu, Sean T. Quinn, Cinty Gong, Evan Leibowitz, Denis Poddubnyy, Lai-Shan Tam, Philip S. Helliwell, Arthur Kavanaugh, Atul Deodhar, Mikkel Østergaard, Xenofon Baraliakos
A home-based, multidisciplinary liver optimisation programme for the first 28 days after an admission for acute-on-chronic liver failure (LivR well): a study protocol for a randomised controlled trial
Natalie LY Ngu, Edward Saxby, Thomas Worland, Patricia Anderson, Lisa Stothers, Anita Figredo, Jo Hunter, Alexander Elford, Phil Ha, Imogen Hartley, Andrew Roberts, Dean Seah, George Tambakis, Danny Liew, Benjamin Rogers, William Sievert, Sally Bell, Suong Le
The effects of aerobic exercise on body composition in overweight and obese patients with gout: a randomized, open-labeled, controlled trial
Ertao Jia, Haiqiong Zhu, Hongling Geng, Ruilin Liu, Xueqian Wo, Yaochi Zeng, Wukai Ma, Xueming Yao, Zhiying Zhan, Jianyong Zhang
Immediate effects of hip strap and foot orthoses on self-reported measures and lower limb kinematics during functional tasks in individuals with patellofemoral osteoarthritis: protocol for a randomised crossover clinical trial
Larissa Rodrigues Souto, Paula Regina Mendes da Silva Serrão, Giulia Keppe Pisani, Bruna Mariana Tessarin, Hygor Ferreira da Silva, Eliane de Morais Machado, Tatiana de Oliveira Sato, Fábio Viadanna Serrão
Overestimation of benefit when clinical trials stop early: a simulation study
Sharon Liu, Scott R. Garrison
Protocol for the development of a core domain set for individuals with ankle osteoarthritis
Sultan Ayyadah Alanazi, Bill Vicenzino, Christiaan J. A. van Bergen, David J. Hunter, Erik A. Wikstrom, Hylton B. Menz, Yvonne M. Golightly, Michelle D. Smith
Study protocol: Effects of active versus passive recharge burst spinal cord stimulation on pain experience in persistent spinal pain syndrome type 2: a multicentre randomized trial (BURST-RAP study)
Martijn R. Mons, Caro Edelbroek, Xander Zuidema, Katja Bürger, Lars Elzinga, Jessica de Vries, Sander van Kuijk, Elbert A. Joosten, Jan-Willem Kallewaard
Pediatric Tuina for functional constipation in children: study protocol for a randomized controlled trail
Xinghe Zhang, Luan Hu, Li Li, Yuanwang Wang, Can Zhang, Jinyan Su, Hua Di, Qing Gao, Xiantao Tai, Taipin Guo
OnTrack Chile for people with early psychosis: a study protocol for a Hybrid Type 1 trial
Franco Mascayano, Iruma Bello, Howard Andrews, Diego Arancibia, Tamara Arratia, María Soledad Burrone, Sarah Conover, Kim Fader, Maria Jose Jorquera, Mauricio Gomez, Sergio Malverde, Gonzalo Martínez-Alés, Jorge Ramírez, Gabriel Reginatto, Alexandra Restrepo-Henao, Robert A. Rosencheck, Sara Schilling, Thomas E. Smith, Gonzalo Soto-Brandt, Eric Tapia, Tamara Tapia, Paola Velasco, Melanie M. Wall, Lawrence H. Yang, Leopoldo J. Cabassa, Ezra Susser, Lisa Dixon, Rubén Alvarado
Using a qualitative sub-study to inform the design and delivery of randomised controlled trials on medicinal cannabis for symptom relief in patients with advanced cancer
Rebecca E. Olson, Alexandra Smith, Georgie Huggett, Phillip Good, Morgan Dudley, Janet Hardy
Comparative effectiveness of two behavioral change intervention packages for tobacco cessation initiated in the tertiary care setting of North India—protocol for a two-arm randomized controlled trial
Priyanka Dhawan, Sonu Goel, Ashutosh Aggarwal, Abhishek Ghosh, Rajesh Vijayvergiya, Bikash Medhi, Dheeraj Khurana, Roshan Verma
Optimizing a Bayesian hierarchical adaptive platform trial design for stroke patients
Guangyi Gao, Byron J. Gajewski, Jo Wick, Jonathan Beall, Jeffrey L. Saver, Caitlyn Meinzer, Colin Derdeyn, David Fiorella, Tudor Jovin, Pooja Khatri, Eva Mistry, J. Mocco, Raul Nogueira, Adnan Siddiqui
The iHealth-T2D study: a cluster randomised trial for the prevention of type 2 diabetes amongst South Asians with central obesity and prediabetes—a statistical analysis plan
Mirthe Muilwijk, Marie Loh, Sara Mahmood, Saranya Palaniswamy, Samreen Siddiqui, Wnurinham Silva, Gary S. Frost, Heather M. Gage, Marjo-Riitta Jarvelin, Ravindra P. Rannan-Eliya, Sajjad Ahmad, Sujeet Jha, Anuradhani Kasturiratne, Prasad Katulanda, Khadija I. Khawaja, Jaspal S. Kooner, Ananda R. Wickremasinghe, Irene G. M. van Valkengoed, John C. Chambers
Recruitment interventions for trials involving adults lacking capacity to consent: methodological and ethical considerations for designing Studies Within a Trial (SWATs)
Victoria Shepherd, Fiona Wood, Katie Gillies, Abby O’Connell, Adam Martin, Kerenza Hood
Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units
Sharon B. Love, Fay Cafferty, Claire Snowdon, Karen Carty, Joshua Savage, Philip Pallmann, Lucy McParland, Louise Brown, Lindsey Masters, Francesca Schiavone, Dominic Hague, Stephen Townsend, Claire Amos, Annabelle South, Kate Sturgeon, Ruth Langley, Timothy Maughan, Nicholas James, Emma Hall, Sarah Kernaghan, Judith Bliss, Nick Turner, Andrew Tutt, Christina Yap, Charlotte Firth, Anthony Kong, Hisham Mehanna, Colin Watts, Robert Hills, Ian Thomas, Mhairi Copland, Sue Bell, David Sebag-Montefiore, Robert Jones, Mahesh K. B. Parmar, Matthew R. Sydes
A protocol for monitoring fidelity of a preconception-life course intervention in a middle-income setting: the Healthy Life Trajectories Initiative (HeLTI), South Africa
Larske M. Soepnel, Catherine E. Draper, Khuthala Mabetha, Cindy-Lee Dennis, Alessandra Prioreschi, Stephen Lye, Shane A. Norris
Menstrual health interventions, schooling, and mental health problems among Ugandan students (MENISCUS): study protocol for a school-based cluster-randomised trial
Catherine Kansiime, Laura Hytti, Kate Andrews Nelson, Belen Torondel, Suzanna C. Francis, Clare Tanton, Giulia Greco, Sophie Belfield, Shamirah Nakalema, Fred Matovu, Andrew Sentoogo Ssemata, Connie Alezuyo, Stella Neema, John Jerrim, Chris Bonell, Janet Seeley, Helen A. Weiss, Aggrey Tumuhimbise, Christopher Baleke, Denis Ndekezi, Denis Ssenyondwa, Kevin Nakuya, Levicatus Mugenyi, Prossy Namirembe, Ratifah Batuusa, Robert Bakanoma, Stephen Lagony, Titus Kisa Ssesanga
Correction: Trial Forge Guidance 3: randomised trials and how to recruit and retain individuals from ethnic minority groups—practical guidance to support better practice
Shoba Dawson, Katie Banister, Katie Biggs, Seonaidh Cotton, Declan Devane, Heidi Gardner, Katie Gillies, Gosala Gopalakrishnan, Talia Isaacs, Kamlesh Khunti, Alistair Nichol, Adwoa Parker, Amy M. Russell, Victoria Shepherd, Frances Shiely, Gillian Shorter, Bella Starling, Hywel Williams, Andrew Willis, Miles D. Witham, Shaun Treweek
Digital psychosocial intervention for depression among older adults in socioeconomically deprived areas in Brazil (PRODIGITAL-D): protocol for an individually randomised controlled trial
Carina Akemi Nakamura, Marcia Scazufca, Felipe Azevedo Moretti, Thiago Vinicius Nadaleto Didone, Mariana Mendes de Sá Martins, Luara Aragoni Pereira, Caio Hudson Queiroz de Souza, Gabriel Macias de Oliveira, Marcelo Oliveira da Costa, Marcelo Machado, Evelyn da Silva Bitencourt, Monica Souza dos Santos, Jamie Murdoch, Pepijn van de Ven, Nadine Seward, William Hollingworth, Tim J. Peters, Ricardo Araya
Performance of model-based vs. permutation tests in the HEALing (Helping to End Addiction Long-termSM) Communities Study, a covariate-constrained cluster randomized trial
Xiaoyu Tang, Timothy Heeren, Philip M. Westgate, Daniel J. Feaster, Soledad A. Fernandez, Nathan Vandergrift, Debbie M. Cheng
Intravenous versus oral iron for iron deficiency anaemia in pregnant Nigerian women (IVON): study protocol for a randomised hybrid effectiveness-implementation trial
Bosede B. Afolabi, Ochuwa A. Babah, Opeyemi R. Akinajo, Victoria O. Adaramoye, Titilope A. Adeyemo, Mobolanle Balogun, Aduragbemi Banke-Thomas, Rachel A. Quao, Gbenga Olorunfemi, Ajibola I. Abioye, Hadiza S. Galadanci, Nadia A. Sam-Agudu
The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study: International consensus on outcome measures for trials of interventions for adults with single-sided deafness
Roulla Katiri, Deborah A. Hall, Derek J. Hoare, Kathryn Fackrell, Adele Horobin, Nicholas Hogan, Nóra Buggy, Paul H. Van de Heyning, Jill B. Firszt, Iain A. Bruce, Pádraig T. Kitterick, Ad Snik, Carly Sygrove, Cherith Campbell-Bell, Christopher Parker, Daniel M. Zeitler, Lewis Williams, Maxine Oxford, Patrick Boyle, Paul K. James, Penelope R. Hill-Feltham, Peter Toth, Richard Bowles, Richard Nicholson, Roger Bayston, Tove Rosenbom
The effect of the Progressive Goal Attainment Program on cognitions, perceptions, and work participation of workers with chronic health problems: study protocol for a randomized controlled trial
Mariska de Wit, Hendrika P. Zijlstra, Carel T. J. Hulshof, Sylvia J. van der Burg-Vermeulen, Angela G. E. M. de Boer
Reshaping the path of mild cognitive impairment by refining exercise prescription: a study protocol of a randomized controlled trial to understand the “what,” “for whom,” and “how” of exercise to promote cognitive function
Cindy K. Barha, Ryan S. Falck, John R. Best, Lindsay S. Nagamatsu, Ging-Yuek Robin Hsiung, A. William Sheel, Chun Liang Hsu, Arthur F. Kramer, Michelle W. Voss, Kirk I. Erickson, Jennifer C. Davis, J. Kevin Shoemaker, Lara Boyd, Rachel A. Crockett, Lisanne ten Brinke, Louis Bherer, Joel Singer, Liisa A. M. Galea, Claudia Jacova, Alexis Bullock, Sofia Grant, Teresa Liu-Ambrose
Efficacy and safety of 5% lidocaine patches for postoperative pain management in patients undergoing unilateral inguinal hernia repair: study protocol for a prospective, double-blind, randomized, controlled clinical trial
Hong-min Ahn, Heung-Kwon Oh, Duck-Woo Kim, Sung-Bum Kang, Bon-Wook Koo, Pyung-Bok Lee
Study protocol for a randomised controlled trial of diacerein versus placebo to treat knee osteoarthritis with effusion-synovitis (DICKENS)
Guoqi Cai, Graeme Jones, Flavia M. Cicuttini, Anita E. Wluka, Yuanyuan Wang, Catherine Hill, Helen Keen, Benny Antony, Xia Wang, Barbara de Graaff, Michael Thompson, Tania Winzenberg, Kathy Buttigieg, Dawn Aitken
Reversal Of Arterial Disease by modulating Magnesium and Phosphate (ROADMAP-study): rationale and design of a randomized controlled trial assessing the effects of magnesium citrate supplementation and phosphate-binding therapy on arterial stiffness in moderate chronic kidney disease
Emma A. Vermeulen, Coby Eelderink, Tiny Hoekstra, Adriana J. van Ballegooijen, Pieter Raijmakers, Joline W. Beulens, Martin H. de Borst, Marc G. Vervloet
Effectiveness of a complex regional advance care planning intervention to improve care consistency with care preferences: study protocol for a multi-center, cluster-randomized controlled trial focusing on nursing home residents (BEVOR trial)
Kornelia Götze, Claudia Bausewein, Berend Feddersen, Angela Fuchs, Amra Hot, Eva Hummers, Andrea Icks, Änne Kirchner, Evelyn Kleinert, Stephanie Klosterhalfen, Henrike Kolbe, Sonja Laag, Henriette Langner, Susanne Lezius, Gabriele Meyer, Joseph Montalbo, Friedemann Nauck, Christine Reisinger, Nicola Rieder, Jan Schildmann, Michaela Schunk, Henrikje Stanze, Christiane Vogel, Karl Wegscheider, Antonia Zapf, Georg Marckmann, Jürgen in der Schmitten, Annika Albert, Cornelia Alheid, Claudia Bausewein, Manuela Bruene, Christian Calles, Havva Camci, Anne Daubmann, Sophie Dahlke, Stephanie Enger, Berend Feddersen, Gerd Felder, Carsten Fluck, Andreas Freienstein, Theresa Freytag, Angela Fuchs, Andrea Icks, Jürgen in der Schmitten, Lena Hensel, Eva Hummers, Amra Hot, Änne Kirchner, Evelyn Kleinert, Stephanie Klosterhalfen, Henrike Kolbe, Sonja Laag, Henriette Langner, Susanne Lezius, Georg Marckmann, Gabriele Meyer, Jospeh Montalbo, Friedemann Nauck, Thuy Nguyen, Andre Nowak, Malte Ossenberg, Christine Reisinger, Sophia Reuter, Nicola Rieder, Tanja Riester, Irina Rosu, Holger Rösgen, Katharina Salanta, Zeinep Sassi, Jan Schildmann, Thomas Schulenberg, Michaela Schunk, Daniela Sommer, Henrikje Stanze, Andreas Stöhr, Anke Theuerkauf, Nancy Thilo, Jessica Tönjann, Mahnaz Partowinia-Peters, Sebastian Prommersberger, Susanne Przybylla, Christiane Vogel, Markus Vomhof, Janka Wilken, Antonia Zapf, Jennifer Zimprich
Effect of pulsed electromagnetic field as an intervention for patients with quadriceps weakness after anterior cruciate ligament reconstruction: a double-blinded, randomized-controlled trial
Michael Tim-Yun Ong, Gene Chi-Wai Man, Lawrence Chun-Man Lau, Xin He, Jihong Qiu, Qianwen Wang, Matthew Chun-Sing Chow, Ben Chi-Yin Choi, Mingqian Yu, Patrick Shu-Hang Yung
A pragmatic randomized trial evaluating pre-operative aqueous antiseptic skin solutions in open fractures (Aqueous-PREP): statistical analysis plan
Nathan N. O’Hara, Diane Heels-Ansdell, Sofia Bzovsky, Shannon Dodds, Lehana Thabane, Mohit Bhandari, Gordon Guyatt, P. J. Devereaux, Gerard P. Slobogean, Sheila Sprague, Anthony D. Harris, C. Daniel Mullins, Jeffrey Wells, Amber Wood, Gregory J. Della Rocca, Joan Hebden, Kyle J. Jeray, Lucas S. Marchand, Lyndsay M. O’Hara, Robert Zura, Christopher Lee, Joseph Patterson, Michael J. Gardner, Jenna Blasman, Jonah Davies, Stephen Liang, Monica Taljaard, Lehana Thabane, Debra Marvel, Jana Palmer, Jeff Friedrich, Frances Grissom, I. Leah Gitajn, Saam Morshed, Robert V. O’Toole, Bradley A. Petrisor, Franca Mossuto, Manjari G. Joshi, Jean-Claude D’Alleyrand, Justin Fowler, Jessica Rivera, Max Talbot, Sheila Sprague, David Pogorzelski, Silvia Li, Alejandra Rojas, Gina Del Fabbro, Olivia Paige Szasz, Paula McKay, Alexandra Minea, Kevin Murphy, Andrea Howe, Haley K. Demyanovich, Michelle Medeiros, Genevieve Polk, Eric Kettering, Nirmen Mahal, Andrew Eglseder, Aaron Johnson, Christopher Langhammer, Christopher Lebrun, Jason Nascone, Raymond Pensy, Andrew Pollak, Marcus Sciadini, Yasmin Degani, Heather Phipps, Eric Hempen, Herman Johal, Bill Ristevski, Dale Williams, Matthew Denkers, Krishan Rajaratnam, Jamal Al-Asiri, Jodi Gallant, Kaitlyn Pusztai, Sarah MacRae, Sara Renaud, John D. Adams, Michael L. Beckish, Christopher C. Bray, Timothy R. Brown, Andrew W. Cross, Timothy Dew, Gregory K. Faucher, Richard W. Gurich Jr, David E. Lazarus, S. John Millon, M. Jason Palmer, Scott E. Porter, Thomas M. Schaller, Michael S. Sridhar, John L. Sanders, L. Edwin Rudisill Jr, Kyle M. Altman, Julia C. Quirion, Markus F. Loeffler, Erin R. Pichiotino, Austin A. Cole, Ethan J. Maltz, Wesley Parker, T. Bennett Ramsey, Alex Burnikel, Michael Colello, Russell Stewart, Jeremy Wise, M. Christian Moody, Matthew Anderson, Joshua Eskew, Benjamin Judkins, James M. Miller, Stephanie L. Tanner, Rebecca G. Snider, Emily Bray, Harper Abbott, Roman M. Natoli, Todd O. McKinley, Walter W. Virkus, Anthony T. Sorkin, Jan P. Szatkowski, Brian H. Mullis, Yohan Jang, Luke A. Lopas, Lauren C. Hill, Courteney L. Fentz, Maricela M. Diaz, Krista Brown, Katelyn M. Garst, Emma W. Denari, Patrick Osborn, Sarah Pierrie, Maria Herrera, Theodore Miclau, Meir Marmor, Amir Matityahu, R. Trigg McClellan, David Shearer, Paul Toogood, Anthony Ding, Jothi Murali, Ashraf El Naga, Jennifer Tangtiphaiboontana, Tigist Belaye, Eleni Berhaneselase, Dmitry Pokhvashchev, William T. Obremskey, Amir Alex Jahangir, Manish Sethi, Robert Boyce, Daniel J. Stinner, Phillip Mitchell, Karen Trochez, Elsa Rodriguez, Charles Pritchett, Natalie Hogan, A. Fidel Moreno, Jennifer E. Hagen, Matthew Patrick, Richard Vlasak, Thomas Krupko, Michael Talerico, Marybeth Horodyski, Chris Koenig, Marissa Pazik, Elizabeth Lossada-Soto, Joshua L. Gary, Stephen J. Warner, John W. Munz, Andrew M. Choo, Timothy S. Achor, Milton L. Chip Routt, Michael Kutzler, Sterling Boutte, Ryan J. Warth, Michael Prayson, Indresh Venkatarayappa, Brandon Horne, Jennifer Jerele, Linda Clark, Christina Boulton, Jason Lowe, John T. Ruth, Brad Askam, Andrea Seach, Alejandro Cruz, Breanna Featherston, Robin Carlson, Iliana Romero, Isaac Zarif, Niloofar Dehghan, Michael McKee, Debra L. Sietsema, Alyse Williams, Tayler Dykes, Ernesto Guerra-Farfan, Jordi Tomas-Hernandez, Jordi Teixidor-Serra, Vicente Molero-Garcia, Jordi Selga-Marsa, Juan Antonio Porcel-Vazquez, Jose Vicente Andres-Peiro, Joan Minguell-Monyart, Jorge Nuñez-Camarena, Maria del Mar Villar-Casares, Jaume Mestre-Torres, Pilar Lalueza-Broto, Felipe Moreira-Borim, Yaiza Garcia-Sanchez, Francesc Marcano-Fernández, Laia Martínez-Carreres, David Martí-Garín, Jorge Serrano-Sanz, Joel Sánchez-Fernández, Matsuyama Sanz-Molero, Alejandro Carballo, Xavier Pelfort, Francesc Acerboni-Flores, Anna Alavedra-Massana, Neus Anglada-Torres, Alexandre Berenguer, Jaume Cámara-Cabrera, Ariadna Caparros-García, Ferran Fillat-Gomà, Ruben Fuentes-López, Ramona Garcia-Rodriguez, Nuria Gimeno-Calavia, Marta Martínez-Álvarez, Patricia Martínez-Grau, Raúl Pellejero-García, Ona Ràfols-Perramon, Juan Manuel Peñalver, Mònica Salomó Domènech, Albert Soler-Cano, Aldo Velasco-Barrera, Christian Yela-Verdú, Mercedes Bueno-Ruiz, Estrella Sánchez-Palomino, Vito Andriola, Matilde Molina-Corbacho, Yeray Maldonado-Sotoca, Alfons Gasset-Teixidor, Jorge Blasco-Moreu, Núria Fernández-Poch, Josep Rodoreda-Puigdemasa, Arnau Verdaguer-Figuerola, Heber Enrique Cueva-Sevieri, Santiago Garcia-Gimenez, Darius G. Viskontas, Kelly L. Apostle, Dory S. Boyer, Farhad O. Moola, Bertrand H. Perey, Trevor B. Stone, H. Michael Lemke, Ella Spicer, Kyrsten Payne, Robert A. Hymes, Cary C. Schwartzbach, Jeff E. Schulman, A. Stephen Malekzadeh, Michael A. Holzman, Greg E. Gaski, Jonathan Wills, James S. Ahn, Sharmistha Das, Antoinisha D. English, Jaslynn A. N. Cuff, Holly Pilson, Eben A. Carroll, Jason J. Halvorson, Sharon Babcock, J. Brett Goodman, Martha B. Holden, Wendy Williams, Taylor Hill, Ariel Brotherton, Nicholas M. Romeo, Heather A. Vallier, Joanne Fraifogl, Anna Vergon, Thomas F. Higgins, Justin M. Haller, David L. Rothberg, Ashley Neese, Zachary M. Olsen, Abby V. McGowan, Sophia Hill, Morgan K. Dauk, Patrick F. Bergin, George V. Russell, Matthew L. Graves, John Morellato, Sheketha L. McGee, Eldrin L. Bhanat, Ugur Yener, Rajinder Khanna, Priyanka Nehete, David Potter, Robert VanDemark III, Kristi Atkins, Marcus Coe, Kevin Dwyer, Devin S. Mullin, Theresa A. Chockbengboun, Kevin Phelps, Michael Bosse, Madhav Karunakar, Laurence Kempton, Stephen Sims, Joseph Hsu, Rachel Seymour, Christine Churchill, Ada Mayfield, Juliette Sweeney, Todd Jaeblon, Robert Beer, Brent Bauer, Sean Meredith, Caroline Benzel, Christopher M. Domes, Rachel M. Reilly, Ariana Paniagua, Ja Nell Dupree, Michael J. Weaver, Arvind G. von Keudell, Abigail E. Sagona, Samir Mehta, Derek Donegan, Annamarie Horan, Mary Dooley, Marilyn Heng, Mitchel B. Harris, David W. Lhowe, John G. Esposito, Ahmad Alnasser, Steven F. Shannon, Alesha N. Scott, Bobbi Clinch, Becky Weber, Michael J. Beltran, Michael T. Archdeacon, Henry Claude Sagi, John D. Wyrick, Theodore Toan Le, Richard T. Laughlin, Cameron G. Thomson, Kimberly Hasselfeld, Carol A. Lin, Mark S. Vrahas, Charles N. Moon, Milton T. Little, Geoffrey S. Marecek, Denice M. Dubuclet, John A. Scolaro, James R. Learned, Philip K. Lim, Susan Demas, Arya Amirhekmat, Yan Marco Dela Cruz
The CHALLENGE trial: the effects of a virtual reality-assisted exposure therapy for persistent auditory hallucinations versus supportive counselling in people with psychosis: study protocol for a randomised clinical trial
L. C. Smith, L. Mariegaard, D. L. Vernal, A. G. Christensen, N. Albert, N. Thomas, C. Hjorthøj, L. B. Glenthøj, M. Nordentoft
The CHARTER-Ireland trial: can nebulised heparin reduce acute lung injury in patients with SARS-CoV-2 requiring advanced respiratory support in Ireland: a study protocol and statistical analysis plan for a randomised control trial
John Robert Sheehan, Padraig Calpin, Maeve Kernan, Claire Kelly, Siobhan Casey, Darragh Murphy, Alberto Alvarez-Iglesias, Camilla Giacomini, Catriona Cody, Gerard Curley, Shane McGeary, Ciara Hanley, Bairbre McNicholas, Frank van Haren, John G. Laffey, David Cosgrave
Study protocol for a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-naïve infants (9 to 10 months) in The Gambia [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial]
Ikechukwu Adigweme, Edem Akpalu, Mohammed Yisa, Simon Donkor, Lamin B. Jarju, Baba Danso, Anthony Mendy, David Jeffries, Abdoulie Njie, Andrew Bruce, Michael Royals, James L. Goodson, Mark R. Prausnitz, Devin McAllister, Paul A. Rota, Sebastien Henry, Ed Clarke
PRE-OPerative ECHOcardiograhy for prevention of cardiovascular events after non-cardiac surgery in intermediate- and high-risk patients: protocol for a low-interventional, mixed-cohort prospective study design (PREOP-ECHO)
Eun Kyoung Kim, Hong-Mi Choi, Eui-Young Choi, Hye Sun Lee, Goeun Park, Dong Woo Han, Sang-Eun Lee, Chan Seok Park, Ji-won Hwang, Jae Hyuk Choi, Mi-Na Kim, Hyung-Kwan Kim, Dae-Hee Kim, Sung-Hee Shin, Il Suk Sohn, Mi-Seung Shin, Jin Oh Na, Iksung Cho, Sun Hwa Lee, Yong Hyun Park, Tae-Ho Park, Kye Hun Kim, Goo-Young Cho, Hae Ok Jung, Dae-Gyun Park, Ji Yeon Hong, Duk-Hyun Kang
Effectiveness, safety and cost-effectiveness of vaporized nicotine products versus nicotine replacement therapy for tobacco smoking cessation in a low-socioeconomic status Australian population: a study protocol for a randomized controlled trial
Bridget C Howard, Hayden McRobbie, Dennis Petrie, Daniel Barker, Colin Mendelsohn, Jack Anderson, Ron Borland, Felix Naughton, Piotr Tutka, Nick Zwar, Veronica C Boland, Alexandra Aiken, Anthony Shakeshaft, Coral Gartner, Robyn L Richmond, Wayne Hall, Richard P Mattick, Michael Farrell, Ryan J Courtney
Cognitive-motor telerehabilitation in multiple sclerosis (CoMoTeMS): study protocol for a randomised controlled trial
Delphine Van Laethem, Frederik Van de Steen, Daphne Kos, Maarten Naeyaert, Peter Van Schuerbeek, Miguel D’Haeseleer, Marie B. D’Hooghe, Jeroen Van Schependom, Guy Nagels
Development and evaluation of an electronic algorithm using a combination of a two-step malaria RDT and other rapid diagnostic tools for the management of febrile illness in children under 5 attending outpatient facilities in Burkina Faso
Francois Kiemde, Adelaide Compaore, Fla Koueta, Athanase M. Some, Berenger Kabore, Daniel Valia, Toussaint Rouamba, Fadima Yaya Bocoum, Seydou Sawadogo, Macaire Nana, Diane Y. Some, Nadine A. Kone, Valentin Pagbeleguem, Inoussa Sangare, Antonia W. Bere, Massa dit Achille Bonko, Gautier Tougri, Sylvie Yeri Youl, Henk Schallig, Halidou Tinto
Rapamycin and inulin for booster vaccine response stimulation (RIVASTIM)—rapamycin: study protocol for a randomised, controlled trial of immunosuppression modification with rapamycin to improve SARS-CoV-2 vaccine response in kidney transplant recipients
Matthew Tunbridge, Griffith B. Perkins, Julian Singer, Tania Salehi, Tracey Ying, Branka Grubor-Bauk, Simon Barry, Beatrice Sim, Pravin Hissaria, Steven J. Chadban, P. Toby Coates
Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial
Yohan Kwon, Eung Tae Kim, Soo Buem Cho, Jae Hwan Lee, Dong Jae Shim
A study protocol for a double-blind randomised placebo-controlled trial evaluating the efficacy of carrageenan nasal and throat spray for COVID-19 prophylaxis—ICE-COVID
Z. M. Jessop, J. Gibson, J. Y. Lim, T. H. Jovic, E. Combellack, T. D. Dobbs, K. Carter, S. Hiles, S. Islam, B. Healy, I. Humphreys, R. Eccles, H. A. Hutchings, I. S. Whitaker
Identifying obstacles hindering the conduct of academic-sponsored trials for drug repurposing on rare-diseases: an analysis of six use cases
Marta del Álamo, Christoph Bührer, Dirk Fisher, Matthias Griese, Paul Lingor, Giovanni Palladini, Nicolas Sireau, Virginie Hivert, Luca Sangiorgi, Florence Guillot, Juliane Halftermeyer, Lenka Soucková, Kristýna Nosková, Regina Demlová
Effect of EARLY administration of DEXamethasone in patients with COVID-19 pneumonia without acute hypoxemic respiratory failure and risk of development of acute respiratory distress syndrome (EARLY-DEX COVID-19): study protocol for a randomized controlled trial
Anabel Franco-Moreno, María Soledad Acedo-Gutiérrez, Nicolás Labrador-San Martín, Clara Hernández-Blanco, Celia Rodríguez-Olleros, Fátima Ibáñez-Estéllez, Ana Suárez-Simón, Mateo Balado-Rico, Ana Rocío Romero-Paternina, David Alonso-Menchén, Belén Escolano-Fernández, Esther Piniella-Ruiz, Ester Alonso-Monge, Helena Notario-Leo, Carlos Bibiano-Guillén, Gabriela Peña-Lillo, Armando Antiqueira-Pérez, Rodolfo Romero-Pareja, Noemí Cabello-Clotet, Vicente Estrada-Pérez, Jesús Troya-García, María de Carranza-López, Ismael Escobar-Rodríguez, Nacho Vallejo-Maroto, Juan Torres-Macho
Promoting the adoption of local governmental policy on the reimbursement of chronic disease medicines (PAPMed): study protocol of a field-based cluster randomized trial in rural Nantong, China
Zhengting He, Xin Cao, Duan Zhao, Zemin Tang, Jiayu Zhao, Mariel Beasley, Angela Renne, Lei Liu, Shengjie Zhu, Yuexia Gao, Lijing L. Yan
Re-analysis on the statistical sampling biases of a mask promotion trial in Bangladesh: a statistical replication
Maria Chikina, Wesley Pegden, Benjamin Recht
Study protocol for the management of impacted maxillary central incisors: a multicentre randomised clinical trial: the iMAC Trial
Jadbinder Seehra, Andrew T. DiBiase, Shruti Patel, Rachel Stephens, Simon J. Littlewood, Richard J. Spencer, Tom Frawley, Philip E. Benson, Anthony J. Ireland, Farnaz Parvizi, Nikki Atack, Giles Kidner, Gabriella Wojewodka, Christopher Ward, Spyridon N. Papageorgiou, Jonathon T. Newton, Martyn T. Cobourne
Impact of tight blood glucose control within normal fasting ranges with insulin titration prescribed by the Leuven algorithm in adult critically ill patients: the TGC-fast randomized controlled trial
Jan Gunst, Liese Mebis, Pieter J. Wouters, Greet Hermans, Jasperina Dubois, Alexander Wilmer, Eric Hoste, Dominique Benoit, Greet Van den Berghe
Acipimox in Mitochondrial Myopathy (AIMM): study protocol for a randomised, double-blinded, placebo-controlled, adaptive design trial of the efficacy of acipimox in adult patients with mitochondrial myopathy
Alaa Abouhajar, Lisa Alcock, Theophile Bigirumurame, Penny Bradley, Laura Brown, Ian Campbell, Silvia Del Din, Julie Faitg, Gavin Falkous, Gráinne S. Gorman, Rachel Lakey, Robert McFarland, Jane Newman, Lynn Rochester, Vicky Ryan, Hesther Smith, Alison Steel, Renae J. Stefanetti, Huizhong Su, Robert W. Taylor, Naomi J.P. Thomas, Helen Tuppen, Amy E. Vincent, Charlotte Warren, Gillian Watson
Inhaled aviptadil for the possible treatment of COVID-19 in patients at high risk for ARDS: study protocol for a randomized, placebo-controlled, and multicenter trial
Maria Boesing, Kristin Abig, Michael Brändle, Martin Brutsche, Emanuel Burri, Björn C. Frye, Stéphanie Giezendanner, Jan C. Grutters, Philippe Haas, Justian Heisler, Fabienne Jaun, Anne B. Leuppi-Taegtmeyer, Giorgia Lüthi-Corridori, Joachim Müller-Quernheim, Reto Nüesch, Wolfgang Pohl, Frank Rassouli, Jörg D. Leuppi
Examining the impact of a symptom assessment application on patient-physician interaction among self-referred walk-in patients in the emergency department (AKUSYM): study protocol for a multi-center, randomized controlled, parallel-group superiority trial
Hendrik Napierala, Marvin Kopka, Maria B. Altendorf, Myrto Bolanaki, Konrad Schmidt, Sophie K. Piper, Christoph Heintze, Martin Möckel, Felix Balzer, Anna Slagman, Malte L. Schmieding
Ultrasound-guided, continuous erector spinae plane (ESP) block in minimally invasive thoracic surgery—comparing programmed intermittent bolus (PIB) vs continuous infusion on quality of recovery and postoperative respiratory function: a double-blinded randomised controlled trial
Aisling Ni Eochagain, Aneurin Moorthy, Áine O’Gara, Donal J. Buggy
Correction: Effectiveness of a training intervention to improve the management of vertigo in primary care: a multicentre cluster-randomised trial, VERTAP
Jenniffer Elizabeth Pérez Patiño, José Lluís Ballvé Moreno, Yolanda Rando Matos, Jesús Almeda Ortega, Oriol Cunillera Puértolas, Ricard Carrillo Muñoz, Iván Villar Balboa, Xavier González Compta, Olga Lucía Arias Agudelo, Sebastiá Calero Muñoz, Vanessa Monforte Rodríguez, Anna Navarro Cortes, Eva Peguero Rodríguez
Creating concise and readable patient information sheets for interventional studies in Australia: are we there yet?
Tanya Symons, Joshua S. Davis
A randomised placebo-controlled trial of the effectiveness of early metformin in addition to usual care in the reduction of gestational diabetes mellitus effects (EMERGE): study protocol
F. Dunne, C. Newman, D. Devane, A. Smyth, A. Alvarez-Iglesias, P. Gillespie, M. Browne, M. O’Donnell
Follow-up study of infants recruited to the randomised, placebo-controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants—study protocol for the AZTEC-FU study
Sarah J. Kotecha, Christopher W. Course, Kathryn E. Jones, W. John Watkins, Janet Berrington, David Gillespie, Sailesh Kotecha
Internet-based cognitive therapy for women with antenatal depressive symptoms during the COVID-19 pandemic: protocol for a multi-center randomized controlled trial across China
Chen-Chi Duan, Jia-Le Yu, Jing Tao, Chen Zhang, Dan Zhang, Xiu Zeng, Wan-Ting Zeng, Hua-Lin Xu, Jian-Yin Qiu, Cindy-Lee Dennis, Li Jin, He-Feng Huang, Yan-Ting Wu
Fluid balance neutralization secured by hemodynamic monitoring versus protocolized standard of care in critically ill patients requiring continuous renal replacement therapy: study protocol of the GO NEUTRAL randomized controlled trial
Laurent Bitker, Pierre Pradat, Claire Dupuis, Kada Klouche, Julien Illinger, Bertrand Souweine, Jean-Christophe Richard
Optimal target blood pressure in elderly with septic shock (OPTPRESS) trial: study protocol for a randomized controlled trial
Akira Endo, Kazuma Yamakawa, Takashi Tagami, Yutaka Umemura, Kyosuke Takahashi, Hiroki Nagasawa, Yuichi Araki, Mitsuaki Kojima, Toshiki Sera, Masayuki Yagi, Ryo Yamamoto, Jiro Takahashi, Masaki Nakane, Chikashi Takeda, Chihiro Narita, Satoshi Kazuma, Hiroko Okura, Hiroyuki Takahashi, Takeshi Wada, Shu Tahara, Ayaka Matsuoka, Todani Masaki, Atsushi Shiraishi, Keiichiro Shimoyama, Yuta Yokokawa, Rintaro Nakamura, Hisako Sageshima, Yuichiro Yanagida, Kunihiko Takahashi, Yasuhiro Otomo
Effects of intravenous lidocaine on hypoxemia induced by propofol-based sedation for gastrointestinal endoscopy procedures: study protocol for a prospective, randomized, controlled trial
Xiu-Ru Qi, Jing-Yi Sun, Li-Xin An, Ke Zhang, Fu-Shan Xue
Study protocol for a randomized controlled trial evaluating the effectiveness of an internet-based self-help intervention to cope with psychological distress due to COVID-19 in the Italian general population: the RinasciMENTE project
Vanessa Bertuzzi, Michelle Semonella, Gerhard Andersson, Gian Mauro Manzoni, Gianluca Castelnuovo, Enrico Molinari, Giada Pietrabissa
The impact of interactive book sharing on child cognitive and socio-cognitive development (the REaL trial): study protocol for a randomized controlled trial
Linda Forssman, Janna M. Gottwald
The haemostatic effect of deep-frozen platelets versus room temperature-stored platelets in the treatment of surgical bleeding: MAFOD—study protocol for a randomized controlled non-inferiority trial
Tim W. H. Rijnhout, Femke Noorman, Robert A. van der Horst, Edward C. T. H. Tan, Victor V. A. Viersen, Oscar J. F. van Waes, Leo M. G. van de Watering, B. L. S. Borger van der Burg, Jaap J. Zwaginga, Michael H. J. Verhofstad, Rigo Hoencamp
Impact of emergency physician-performed ultrasound for the evaluation of patients with acute abdominal pain, prospective randomized dual Centre study: study protocol for a diagnostic trial
François Brau, Stéphanie Martin, Quentin Le Bastard, Patricia Ricaud, Arnaud Legrand, Emmanuel Montassier, Philippe Le Conte
Improve the cervical cancer prevention behaviors through mobile-based educational intervention based on I-CHANGE model: study protocol for a randomized controlled trial
Sara Kazemi, Fatemeh Zarei, Alireza Heidarnia, Fatemeh Alhani
Stepped care management of insomnia co-occurring with sleep apnea: the AIR study protocol
E. Devon Eldridge-Smith, Rachel Manber, Sheila Tsai, Clete Kushida, Bryan Simmons, Rachel Johnson, Roxane Horberg, Ann Depew, Aysha Abraibesh, Norah Simpson, Matthew Strand, Colin A. Espie, Jack D. Edinger
Structured implementation of digital, systematically updated guideline recommendations for enhanced adherence in schizophrenia (SISYPHOS)—protocol of a cluster-randomized trial
Carolin Lorenz, Gabriele Gaigl, Duygu Güler, Theresa Halms, Naiiri Khorikian-Ghazari, Astrid Röh, Marco Schneider, Elias Wagner, Thomas Schneider-Axmann, Angelika Kapfhammer, Marisa Flick, Charline Pielenz, Eva Salveridou-Hof, Peter Falkai, Wolfgang Gaebel, Alkomiet Hasan, Stefan Leucht
The effects of an integrated mindfulness-based tai chi chuan programme on sleep disturbance among community-dwelling elderly people: protocol for a randomized controlled trial
Sunny Ho-Wan Chan, Siu-Man Ng, Chong-Ho Yu, Ching-Man Chan, Shu-Mei Wang, Wai-Chi Chan
Prophylactic abdominal drainage or no drainage after distal pancreatectomy (PANDORINA): a study protocol of a binational multicenter randomized controlled trial
F. L. Vissers, A. Balduzzi, E. A. van Bodegraven, J. van Hilst, S. Festen, M. Abu Hilal, H. J. Asbun, J. S. D. Mieog, B. Groot Koerkamp, O. R. Busch, F. Daams, M. Luyer, M. De Pastena, G. Malleo, G. Marchegiani, J. Klaase, I. Q. Molenaar, R. Salvia, H. C. van Santvoort, M. Stommel, D. Lips, M. Coolsen, C. Bassi, C. van Eijck, M. G. Besselink
The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care
Sibel Saya, Lucy Boyd, Patty Chondros, Mairead McNamara, Michelle King, Shakira Milton, Richard De Abreu Lourenco, Malcolm Clark, George Fishman, Julie Marker, Cheri Ostroff, Richard Allman, Fiona M. Walter, Daniel Buchanan, Ingrid Winship, Jennifer McIntosh, Finlay Macrae, Mark Jenkins, Jon Emery
Efficacy of a culturally tailored cognitive-behavioural intervention for Ethiopian children with haematological malignancies: study protocol for randomised controlled trial
Tenaw Gualu Melesse, Janita Pak Chun Chau, William Ho Cheung Li
ASEPTIC: primary antibiotic prophylaxis using co-trimoxazole to prevent SpontanEous bacterial PeritoniTIs in Cirrhosis—study protocol for an interventional randomised controlled trial
Dominic Crocombe, Norin Ahmed, Indran Balakrishnan, Ekaterina Bordea, Marisa Chau, Louise China, Lynsey Corless, Victoria Danquah, Hakim-Moulay Dehbi, John F. Dillon, Ewan H. Forrest, Nick Freemantle, David Peter Gear, Coral Hollywood, Rachael Hunter, Tasheeka Jeyapalan, Yiannis Kallis, Stuart McPherson, Iulia Munteanu, Jim Portal, Paul Richardson, Stephen D. Ryder, Amandeep Virk, Gavin Wright, Alastair O’Brien
A single-center, randomized, parallel design study to evaluate the efficacy of donepezil in improving visuospatial abilities in patients with mild cognitive impairment using eye-tracker: the COG-EYE study protocol for a phase II trial
Ko Woon Kim, Qi Wang, Se Hee Koo, Byoung-Soo Shin
Optimal@NRW: optimized acute care of nursing home residents using an intersectoral telemedical cooperation network — study protocol for a stepped-wedge trial
David Brücken, Jenny Unterkofler, Sophie Pauge, Jonas Bienzeisler, Christian Hübel, Sebastian Zechbauer, Rolf Rossaint, Wolfgang Greiner, Birthe Aufenberg, Rainer Röhrig, Leo Cornelius Bollheimer, Julia Stingl, Martina Ziefle, Julia Offermann, Pia Erdmann, Albrecht Eisert, Lea Koech, Saskia Wilhelmy, Judith Steinfeld, Dominik Groß, Andreas Follmann, Michael Czaplik, Johannes Pollmanns, Thomas Krafft, Simone Böbel, Maresa Neuerer, Jörg Christian Brokmann
Correction: M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID
Valérie Martel-Laferrière, Daniel J. Feaster, Lisa R. Metsch, Bruce R. Schackman, Christine Loignon, Bohdan Nosyk, Hansel Tookes, Czarina N. Behrends, Nelson Arruda, Oluleye Adigun, Marie-Eve Goyer, Michael A. Kolber, Jean-Francois Mary, Allan E. Rodriguez, Iveth G. Yanez, Yue Pan, Rania Khemiri, Lauren Gooden, Aïssata Sako, Julie Bruneau
Effect of anesthesia on the outcome of high-grade glioma patients undergoing supratentorial resection: study protocol for a pragmatic randomized controlled trial
Jia Dong, Dexiang Wang, Huizhong Sun, Min Zeng, Xiaoyuan Liu, Xiang Yan, Ruowen Li, Shu Li, Yuming Peng
Targeted AntiBiotics for Chronic pulmonary diseases (TARGET ABC): can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa-infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis, and asthma? A multicenter, randomized, controlled, open-label trial
Josefin Eklöf, Imane Achir Alispahic, Pradeesh Sivapalan, Torgny Wilcke, Niels Seersholm, Karin Armbruster, Jakob Lyngby Kjærgaard, Mohamad Isam Saeed, Thyge Lynghøj Nielsen, Andrea Browatzki, Rikke Holmen Overgaard, Camilla Sund Fenlev, Zitta Barella Harboe, Helle Frost Andreassen, Therese Sophie Lapperre, Lars Pedersen, Stine Johnsen, Charlotte Suppli Ulrik, Julie Janner, Mia Moberg, Maria Heidemann, Ulla Møller Weinreich, Roxana Vijdea, Hans Linde, Ingrid Titlestad, Sofie Lock Johansson, Flemming Schønning Rosenvinge, Christian Østergaard, Khaled Saoud Ali Ghathian, Lise Gundersen, Christina Wellendorph Christensen, Jette Bangsborg, Torben Tranborg Jensen, Vibeke Muff Sørensen, Thilde Ellingsgaard, Raluca Datcu, John Eugenio Coia, Uffe Bodtger, Jens Ulrik Stæhr Jensen
The clinical evaluation of electroacupuncture combined with mindfulness meditation for overweight and obesity: study protocol for a randomized sham-controlled clinical trial
Ching Yee Chung, Angela Wei Hong Yang, Alexander Foe, Mingdi Li, George Binh Lenon
Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial
Francisco García-Torres, Adrián Tejero-Perea, Ángel Gómez-Solís, Rosario Castillo-Mayén, Maria José Jaén-Moreno, Bárbara Luque, Mario Gálvez-Lara, Araceli Sánchez-Raya, Marcin Jablonski, Beatriz Rodríguez-Alonso, Enrique Aranda
Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)—a study protocol for a randomized clinical trial
Thomas Nordahl Christensen, Chalotte Heinsvig Poulsen, Bea Kolbe Ebersbach, Lene Falgaard Eplov
Effects of meditation on physiological and metabolic parameters in patients with type 2 diabetes mellitus “MindDM”: study protocol for a randomized controlled trial
K. P. C. Dalpatadu, P. Galappatthy, P. Katulanda, S. Jayasinghe
A randomized, double-blind, placebo-controlled, hybrid parallel-arm study of low-dose naltrexone as an adjunctive anti-inflammatory treatment for major depressive disorder
Julia R. Plank, Stephanie C. Glover, Ben D. Moloney, Nicholas R. Hoeh, Frederick Sundram, Rachael L. Sumner, Suresh Muthukumaraswamy, Joanne C. Lin
Factors impacting participation in research during the COVID-19 pandemic: results from a survey of patients in the ophthalmology outpatient department
Dalia Abdulhussein, Timothy E. Yap, Haider Manzar, Serge Miodragovic, Francesca Cordeiro
NAVKIDS2 trial: a multi-centre, waitlisted randomised controlled trial of a patient navigator intervention in children with chronic kidney disease — statistical analysis plan and update to the protocol
Anita van Zwieten, Elizabeth G. Ryan, Patrina Caldwell, Kirsten Howard, Allison Tong, Jonathan C. Craig, Stephen I. Alexander, Martin Howell, Armando Teixeira-Pinto, Carmel M. Hawley, Shilpanjali Jesudason, Amanda Walker, Fiona Mackie, Sean E. Kennedy, Steven McTaggart, Hugh J. McCarthy, Simon A. Carter, Siah Kim, Reginald Woodleigh, Anna Francis, Alistair R. Mallard, Amélie Bernier-Jean, David W. Johnson, Deirdre Hahn, Donna Reidlinger, Elaine Pascoe, Julie Varghese, Charani Kiriwandeniya, Liza Vergara, Nicholas Larkins, Luke Macauley, Michelle Irving, Rabia Khalid, Chandana Guha, Germaine Wong
Observation on the effectiveness and safety of sodium bicarbonate Ringer’s solution in the early resuscitation of traumatic hemorrhagic shock: a clinical single-center prospective randomized controlled trial
Jizhe Zhang, Dong Han, Kun Zhang, Weiqiang Guan, Li Li, Zhengtao Gu
The effect of transcranial direct current stimulation combined with working memory training on working memory deficits in schizophrenic patients: study protocol for a randomized controlled trial
Xiaolin Zhu, Chao Huang, Hongzhen Fan, Fengmei Fan, Yanli Zhao, Meihong Xiu, Yunhui Wang, Yajun Li, Yunlong Tan, Zhiren Wang, Shuping Tan
Testing a very low-carbohydrate adaption of the Diabetes Prevention Program among adults with prediabetes: study protocol for the Lifestyle Education about prediabetes (LEAP) trial
Dina H. Griauzde, Alison O’Brien, William S. Yancy Jr., Caroline R. Richardson, Jamie Krinock, Melissa DeJonckheere, Deanna J. M. Isaman, Kaitlyn Vanias, Samuel Shopinski, Laura R. Saslow
Low dose of morphine to relieve dyspnea in acute respiratory failure (OpiDys): protocol for a double-blind randomized controlled study
Alexandre Demoule, Robin Deleris, Côme Bureau, Said Lebbah, Maxens Decavèle, Martin Dres, Thomas Similowski, Agnes Dechartres
Comparing two advance care planning conversation activities to motivate advance directive completion in underserved communities across the USA: The Project Talk Trial study protocol for a cluster, randomized controlled trial
Lauren J. Van Scoy, Benjamin H. Levi, Cindy Bramble, William Calo, Vernon M. Chinchilli, Lindsey Currin, Denise Grant, Christopher Hollenbeak, Maria Katsaros, Sara Marlin, Allison M. Scott, Amy Tucci, Erika VanDyke, Emily Wasserman, Pamela Witt, Michael J. Green
Increasing the effectiveness of psychotherapy in routine care through blended therapy with transdiagnostic online modules (PsyTOM): study protocol for a randomized controlled trial
Carmen Schaeuffele, Manuel Heinrich, Solveig Behr, Friederike Fenski, Leona Hammelrath, Pavle Zagorscak, Alessa Jansen, Steffi Pohl, Johanna Boettcher, Christine Knaevelsrud
SOULMATE: the Swedish study of liver transplantation for isolated colorectal cancer liver metastases not suitable for operation or ablation, compared to best established treatment—a randomized controlled multicenter trial
Veronica Reivell, Helga Hagman, Johan Haux, Carl Jorns, Per Lindnér, Helena Taflin
Correction: Building Emotional Awareness and Mental Health (BEAM): study protocol for a phase III randomized controlled trial of the BEAM app-based program for mothers of children 18–36 months
E. Bailin Xie, Kaeley M. Simpson, Kristin A. Reynolds, Ryan J. Giuliano, Jennifer L. P. Protudjer, Melanie Soderstrom, Shannon Sauer-Zavala, Gerald F. Giesbrecht, Catherine Lebel, Anna L. Mackinnon, Charlie Rioux, Lara Penner-Goeke, Makayla Freeman, Marlee R. Salisbury, Lianne Tomfohr-Madsen, Leslie E. Roos
The COVID-19 pandemic as a catalyst for innovation: a regulatory framework to assess fit-for-purpose innovative approaches in clinical research
Lada Leyens, Tracy Simkins, Nafsika Kronidou Horst
Impact of health education intervention on demand of women for cervical cancer screening: a cluster-randomized controlled trial
Gerezgiher Buruh Abera, Solomon Mekonen Abebe, Abebaw Gebeyehu Worku
Ceftriaxone compared with penicillin G for the treatment of neurosyphilis: study protocol for a multicenter randomized controlled trial
Fang-Zhi Du, Min-Zhi Wu, Xu Zhang, Rui-Li Zhang, Qian-Qiu Wang
What is the purpose of clinical trial monitoring?
Sharon B. Love, Victoria Yorke-Edwards, Elizabeth Ward, Rebecca Haydock, Katie Keen, Katie Biggs, Gosala Gopalakrishnan, Lucy Marsh, Lydia O’Sullivan, Lisa Fox, Estelle Payerne, Kerenza Hood, Garry Meakin
Effect of electrical impedance-guided PEEP in reducing pulmonary complications after craniotomy: study protocol for a randomized controlled trial
Zihao Zhang, Lianqin Zhang, Jiang Zhu, Jun Dong, Hairui Liu
Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—study protocol for a multicentre randomised controlled trial
Ronny Knol, Emma Brouwer, Thomas van den Akker, Philip L. J. DeKoninck, Enrico Lopriore, Wes Onland, Marijn J. Vermeulen, M. Elske van den Akker–van Marle, Leti van Bodegom–Vos, Willem P. de Boode, Anton H. van Kaam, Irwin K. M. Reiss, Graeme R. Polglase, G. Jeroen Hutten, Sandra A. Prins, Estelle E. M. Mulder, Christian V. Hulzebos, Sam J. van Sambeeck, Mayke E. van der Putten, Inge A. Zonnenberg, Stuart B. Hooper, Arjan B. te Pas
Lessening the Impact of Financial Toxicity (LIFT): a protocol for a multi-site, single-arm trial examining the effect of financial navigation on financial toxicity in adult patients with cancer in rural and non-rural settings
Stephanie B. Wheeler, Caitlin B. Biddell, Michelle L. Manning, Mindy S. Gellin, Neda R. Padilla, Lisa P. Spees, Cynthia D. Rogers, Julia Rodriguez-O’Donnell, Cleo Samuel-Ryals, Sarah A. Birken, Katherine E. Reeder-Hayes, Victoria M. Petermann, Allison M. Deal, Donald L. Rosenstein
An interactive mobile application versus an educational booklet to promote job retention in women undergoing adjuvant chemotherapy for breast cancer: a randomized controlled trial
Victoria S. Blinder, Sujata Patil, Jackie Finik, Della Makower, Monica Muppidi, Wendy G. Lichtenthal, Patricia A. Parker, Maria Claros, Jennifer Suarez, Bharat Narang, Francesca Gany
Comparing the effectiveness of Family Support for Health Action (FAM-ACT) with traditional community health worker-led interventions to improve adult diabetes management and outcomes: study protocol for a randomized controlled trial
Denise J. Deverts, Michele Heisler, Edith C. Kieffer, Gretchen A. Piatt, Felix Valbuena, Jonathan G. Yabes, Claudia Guajardo, Deliana Ilarraza-Montalvo, Gloria Palmisano, Glory Koerbel, Ann-Marie Rosland
A socio-ecological approach to reduce the physical activity drop-out ratio in primary care-based patients with type 2 diabetes: the SENWI study protocol for a randomized control trial
Guillem Jabardo-Camprubí, Judit Bort-Roig, Rafel Donat-Roca, Raimon Milà-Villarroel, Mercè Sitjà-Rabert, Jim McKenna, Anna Puig-Ribera
Development of a measure to assess the quality of proxy decisions about research participation on behalf of adults lacking capacity to consent: the Combined Scale for Proxy Informed Consent Decisions (CONCORD scale)
Victoria Shepherd, Kerenza Hood, Katie Gillies, Fiona Wood
Development and evaluation of couple-based coping strategies with infertility: a protocol for a mixed-methods study
Marzie Reisi, Ashraf Kazemi, Mohammad Reza Abedi
Surgical or non-surgical treatment of plantar fasciopathy (SOFT): study protocol for a randomized controlled trial
Stefan Møller, Henrik Riel, Jens Wester, Ane Simony, Bjarke Viberg, Carsten Jensen
The effects of synbiotic supplementation on enteral feeding tolerance, protein homeostasis, and muscle wasting of critically ill adult patients: a randomized controlled trial
Najmeh Seifi, Reza Rezvani, Alireza Sedaghat, Mohsen Nematy, Majid Khadem-Rezaiyan, Mohammad Safarian
Psychosocial stress induction in vivo vs. in virtuo and the influence of a health app on the acute stress reaction in youths: a study protocol for a randomized controlled trial
Daniel Schleicher, Angelika Ecker, Martin Kocur, Irina Jarvers, Colin Nash, Leonie Götz, Alexandra H. Otto, Stephanie Kandsperger, Romuald Brunner
Digital fetal scalp stimulation (dFSS) versus fetal blood sampling (FBS) to assess fetal wellbeing in labour—a multi-centre randomised controlled trial: Fetal Intrapartum Randomised Scalp Stimulation Trial (FIRSST NCT05306756)
D. J. Murphy, Y. Shahabuddin, S. Yambasu, K. O’Donoghue, D. Devane, A. Cotter, G. Gaffney, L. A. Burke, E. J. Molloy, F. Boland
The BEACON study: an update to the protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem-solving therapy in men who present with intentional self-harm to emergency departments in Ontario
Simon Hatcher, Marnin J. Heisel, Oydeji Ayonrinde, Daniel Corsi, Nicole E. Edgar, Sidney H. Kennedy, Sakina J. Rizvi, Ayal Schaffer, Mark Sinyor
A randomized controlled trial evaluating the effectiveness of a self-management program for adolescents with a chronic condition: a study protocol
Jaunna Gauci, Jacqueline Bloomfield, Sharon Lawn, Susan Towns, Annabelle Hobbs, Katharine Steinbeck
Trauma-focused therapies for post-traumatic stress in psychosis: study protocol for the RE.PROCESS randomized controlled trial
Simone R. Burger, Tineke van der Linden, Amy Hardy, Paul de Bont, Berber van der Vleugel, Anton B. P. Staring, Carlijn de Roos, Catherine van Zelst, Jennifer D. Gottlieb, Kim T. Mueser, Agnes van Minnen, Ad de Jongh, Machteld Marcelis, Mark van der Gaag, David van den Berg
Correction: Acipimox in Mitochondrial Myopathy (AIMM): study protocol for a randomised, double-blinded, placebo-controlled, adaptive design trial of the efficacy of acipimox in adult patients with mitochondrial myopathy
Alaa Abouhajar, Lisa Alcock, Theophile Bigirumurame, Penny Bradley, Laura Brown, Ian Campbell, Silvia Del Din, Julie Faitg, Gavin Falkous, Grainne S. Gorman, Rachel Lakey, Robert McFarland, Jane Newman, Lynn Rochester, Vicky Ryan, Hesther Smith, Alison Steel, Renae J. Stefanetti, Huizhong Su, Robert W. Taylor, Naomi J. P. Thomas, Helen Tuppen, Amy E. Vincent, Charlotte Warren, Gillian Watson
Correction: Interdisciplinary and cross-sectoral perioperative care model in cardiac surgery: implementation in the setting of minimally invasive heart valve surgery (INCREASE)—study protocol for a randomized controlled trial
Susanne G. R. Klotz, Gesche Ketels, Christian A. Behrendt, Hans-Helmut Konig, Sebastian Kohlmann, Bernd Lowe, Johannes Petersen, Sina Stock, Eik Vettorazzi, Antonia Zapf, Inke Zastrow, Christian Zollner, Hermann Reichenspurner, Evaldas Girdauskas
Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents (the TECTO trial): a statistical analysis plan for the randomised clinical trial
Markus Harboe Olsen, Julie Hagstrøm, Nicole Nadine Lønfeldt, Camilla Uhre, Valdemar Uhre, Linea Pretzmann, Sofie Heidenheim Christensen, Christine Thoustrup, Nicoline Løcke Jepsen Korsbjerg, Anna-Rosa Cecilie Mora-Jensen, Melanie Ritter, Janus Engstrøm, Jane Lindschou, Hartwig Roman Siebner, Frank Verhulst, Pia Jeppesen, Jens Richardt Møllegaard Jepsen, Signe Vangkilde, Per Hove Thomsen, Katja Hybel, Line Katrine Harder Clemmesen, Christian Gluud, Kerstin Jessica Plessen, Anne Katrine Pagsberg, Janus Christian Jakobsen
Study in Parkinson’s disease of exercise phase 3 (SPARX3): study protocol for a randomized controlled trial
Charity G. Patterson, Elizabeth Joslin, Alexandra B. Gil, Wendy Spigle, Todd Nemet, Lana Chahine, Cory L. Christiansen, Ed Melanson, Wendy M. Kohrt, Martina Mancini, Deborah Josbeno, Katherine Balfany, Garett Griffith, Mac Kenzie Dunlap, Guillaume Lamotte, Erin Suttman, Danielle Larson, Chantale Branson, Kathleen E. McKee, Li Goelz, Cynthia Poon, Barbara Tilley, Un Jung Kang, Malú Gámez Tansey, Nijee Luthra, Caroline M. Tanner, Jacob M. Haus, Giamila Fantuzzi, Nikolaus R. McFarland, Paulina Gonzalez-Latapi, Tatiana Foroud, Robert Motl, Michael A. Schwarzschild, Tanya Simuni, Kenneth Marek, Anna Naito, Codrin Lungu, Daniel M. Corcos, Terry D. Ellis, Ludy C. Shih, Timothy J. Nordahl, Michael T. Stevenson, Jay L. Alberts, Ashwini K. Rao, Corey Landis, Joe R. Nocera, Madeleine E. Hackney, Elizabeth L. Stegemoller, Angela L. Ridgel, Jan M. Hondzinski, Neil M. Johannsen, Patrick Drummond, Heather Milton, David A. Hinkle, Fay B. Horak, Mitra Afshari, Christopher P. Hurt, Ariel Kidwell, Corinna Conroy, Neil Panchal, Brooke Schultz, Jes Marchbank, Aaron Bloemer, Demetra D. Christou, David E. Vaillancourt, Stephanie Lapierre, Colum D. MacKinnon, Sommer Amundsen-Huffmaster, Kristin Garland, Blake B. Rasmussen, Summer Chapman, Jessica Spahn, Laura Wu, Lee E. Dibble, Genevieve N. Olivier, Art Weltman, William Alex Dalrymple, David Edwards, Corey Rynders, Lauren Miller, Gammon M. Earhart, Kerri S. Rawson, Kelvin Jones, Krista Nelles, Quincy J. Almeida, Marie Saint-Hilaire, Stewart A. Factor, Camilla Kilbane, Brian J. Copeland, Marian L. Dale, Alberto J. Espay, Adolfo Ramirez-Zamora, Amanda Fessenden, Andres F. Deik, Richard Camicioli
A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials
Arnela Suman, Jasmijn van Es, Helga Gardarsdottir, Diederick E. Grobbee, Kimberly Hawkins, Megan A. Heath, Isla S. Mackenzie, Ghislaine van Thiel, Mira G. P. Zuidgeest
Examining evidence of time-dependent treatment effects: an illustration using regression methods
Kim M. Jachno, Stephane Heritier, Robyn L. Woods, Suzanne Mahady, Andrew Chan, Andrew Tonkin, Anne Murray, John J. McNeil, Rory Wolfe
Update on the clinical trial landscape: analysis of ClinicalTrials.gov registration data, 2000–2020
Gillian Gresham, Jill L. Meinert, Arthur G. Gresham, Steven Piantadosi, Curtis L. Meinert
The effect of an integrated care intervention of multidisciplinary mental health treatment and employment services for trauma-affected refugees: study protocol for a randomised controlled trial
Maja Bruhn, Henriette Laugesen, Matilde Kromann-Larsen, Cathrine Selnes Trevino, Lene Eplov, Carsten Hjorthøj, Jessica Carlsson
Meal replacement as a weight loss strategy for night shift workers with obesity: a protocol for a randomized controlled trial
Piumika Sooriyaarachchi, Ranil Jayawardena, Toby Pavey, Neil A. King
Zoledronic Acid for prevention of bone and muscle loss after BAriatric Surgery (ZABAS)-a study protocol for a randomized controlled trial
Søren Gam, Bibi Gram, Claus Bogh Juhl, Anne Pernille Hermann, Stinus Gadegaard Hansen
Eligibility screening older research participants using remote cognitive assessment—experiences and reflections from a primary care randomised controlled trial
Caroline Brundle, Anne Heaven, Andrew Clegg
Developing principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey
Martina Svobodova, Nina Jacob, Kerry Hood, Katie Gillies, Rachel Hale, Jennifer Bostock, Peter Bower, Adrian Edwards, Penelope Farthing, Sarah Rawlinson, Shaun Treweek, Jeremy Howick
Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment (SMARTT): a study protocol for a phase IV pragmatic randomized controlled patient management strategy trial
Annelies Van Rie, Elise De Vos, Emilyn Costa, Lennert Verboven, Felex Ndebele, Tim H. Heupink, Steven Abrams, Noriah Maraba, Heeran Makkan, Trevor Beattie, Zandile Rachel Sibeko, S’thabiso Bohlela, Pulane Segwaba, Emmanuel Ayodeji Ogunbayo, Nomadlozi Mhlambi, Felicia Wells, Leen Rigouts, Gary Maartens, Francesca Conradie, John Black, Sam Potgieter, Boitumelo Fanampe, Anneke Van der Spoel Van Dyk, Salome Charalambous, Gavin Churchyard, Rob Warren
A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network
Julia M. Neuhann, Jannik Stemler, Antonio Carcas, Jesús Frías-Iniesta, Ullrich Bethe, Sarah Heringer, Lea Tischmann, Marouan Zarrouk, Arnd Cüppers, Franz König, Martin Posch, Oliver A. Cornely
Emergency department-based, nurse-initiated, serious illness conversation intervention for older adults: a protocol for a randomized controlled trial
Thidathit Prachanukool, Susan D. Block, Donna Berry, Rachel S. Lee, Sarah Rossmassler, Mohammad A. Hasdianda, Wei Wang, Rebecca Sudore, Mara A. Schonberg, James A. Tulsky, Kei Ouchi
Evaluating a tool to improve engagement and recruitment of under-served groups in trials
Lydia Morris, Jo Dumville, Shaun Treweek, Nasima Miah, Ffion Curtis, Peter Bower
Digital detection of dementia (D3): a study protocol for a pragmatic cluster-randomized trial examining the application of patient-reported outcomes and passive clinical decision support systems
Michael J. Kleiman, Abbi D. Plewes, Arthur Owora, Randall W. Grout, Paul Richard Dexter, Nicole R. Fowler, James E. Galvin, Zina Ben Miled, Malaz Boustani
Managing clustering effects and learning effects in the design and analysis of randomised surgical trials: a review of existing guidance
Elizabeth J. Conroy, Jane M. Blazeby, Girvan Burnside, Jonathan A. Cook, Carrol Gamble
Development of a co-designed behaviour change intervention aimed at healthcare professionals recruiting to clinical trials in maternity care
Vivienne Hanrahan, Louisa Lawrie, Eilidh Duncan, Linda Biesty, Katie Gillies
Development of a core outcome set for hypertensive intracerebral hemorrhage in clinical trials of traditional Chinese medicine: a study protocol
Min Jia, Yan Lu, Xiao Liang, Chenguang Tong, Jian Wang, Jun Tang, Jian Yang, Min Wang, Weiwei Jiao, Wanqing Du, Jingjing Wei, Zixiu Zeng, Zhenmin Xu, Qian Chen, Lin Lei, Xing Liao, Yunling Zhang
RObotic-Assisted Rehabilitation for balance and gait in Stroke patients (ROAR-S): study protocol for a preliminary randomized controlled trial
Silvia Giovannini, Chiara Iacovelli, Fabrizio Brau, Claudia Loreti, Augusto Fusco, Pietro Caliandro, Lorenzo Biscotti, Luca Padua, Roberto Bernabei, Letizia Castelli
The effect of an 8-week treatment program using a novel foot neuromuscular electrical stimulator on physical function, leg pain, leg symptoms, and leg blood flow in community-dwelling older adults: a randomized sham-controlled trial
Binoy Kumaran, Darren Targett, Tim Watson
Pulsed electromagnetic fields for post-appendicectomy pain management: a randomized, placebo-controlled trial
Muralitharan Perumal, Aizatul Isla Abdul Latib, Malarvilee Paul Samy, Mohd Rohisham bin Zainal Abidin, Elanngovan Nagandran, Tham Sim Wan, Pamela Francis, Chee Yoong Foo
Kangyi Qiangshen Gong exercise prescription for pulmonary function and quality of life in patients recovered from COVID-19: a study protocol for a randomized controlled trial
Guangxin Guo, Xiruo Xu, Wong Yu Yin, Kunyu Zhang, Jacelyn Pang Min Hui, Janice Hiew Yuen Yee, Bryan Chung Qi Heng, Yuan Qin, Fei Yao, Min Fang
Comparison of whole brain radiation therapy for synchronous brain metastases with irradiation protecting the hippocampus versus whole brain radiotherapy for sequential brain metastases to boost irradiation in the treatment of brain metastases from SCLC: study protocol for a randomized controlled trial
Xiaofang Zhang, Tianlu Wang, Chen Yu Wang, Peng Zhao, Bo Huang, Lei He, Ying Qiu Song
Transmyringeal ventilation tube insertion for unilateral Menière’s disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial
Casper Grønlund Larsen, Mikael Karlberg, Frank Guldfred, Louise Devantier, Mathias Maagaard, Preben Homøe, Bjarki Ditlev Djurhuus
FORWARDS-1: an adaptive, single-blind, placebo-controlled ascending dose study of acute baclofen on safety parameters in opioid dependence during methadone-maintenance treatment—a pharmacokinetic-pharmacodynamic study
L. M. Paterson, D. Barker, S. Cro, P. Mozgunov, R. Phillips, C. Smith, L. Nahar, S. Paterson, A. R. Lingford-Hughes
StOP? II trial: cluster randomized clinical trial to test the implementation of a toolbox for structured communication in the operating room—study protocol
Sandra Keller, Franziska Tschan, Norbert K. Semmer, Sven Trelle, Tanja Manser, Guido Beldi
Traditional Chinese medicine based on Tongjiang methodology combined with proton pump inhibitor (PPI) step-down in treating non-erosive reflux disease: a study protocol for a multicentered, randomized controlled clinical trial
Xia Li, Haomeng Wu, Beihua Zhang, Ting Chen, Xiaoshuang Shi, Jinxin Ma, Jiaqi Zhang, Xudong Tang, Fengyun Wang
Experiences of the Data Monitoring Committee for the RECOVERY trial, a large-scale adaptive platform randomised trial of treatments for patients hospitalised with COVID-19
Peter A. G. Sandercock, Janet Darbyshire, David DeMets, Robert Fowler, David G. Lalloo, Mohammed Munavvar, Natalie Staplin, Adilia Warris, Janet Wittes, Jonathan R. Emberson
Effect of different feeding methods on gastrointestinal function in critical patients (DFM-GFC): study protocol for a randomized controlled trial
Guang Yang, Aijing Deng, Bojun Zheng, Jian Li, Yi Yu, Honglian Ouyang, Xin Huang, Hong Chen
Understanding the perspectives of recruiters is key to improving randomised controlled trial enrolment: a qualitative evidence synthesis
Nicola Farrar, Daisy Elliott, Catherine Houghton, Marcus Jepson, Nicola Mills, Sangeetha Paramasivan, Lucy Plumb, Julia Wade, Bridget Young, Jenny L. Donovan, Leila Rooshenas
WILL (When to Induce Labour to Limit risk in pregnancy hypertension): a multicentre randomised controlled trial — adaptations to deliver a timing-of-birth trial during the COVID-19 international pandemic
Laura A. Magee, Sue Tohill, Katie Kirkham, Ruth Evans, Eleni Gkini, Catherine A. Moakes, Clive Stubbs, Jim Thornton, Peter von Dadelszen, Peter Brocklehurst, Lucy Chappell, Jon Dorling, Marcus Green, Pollyanna Hardy, Jennifer Hutcheon, Katie Kirkham, Catherine Moakes, Ben Mol, Katie Morris, Paul Riley, Tracy Roberts, Janet Scott, Joel Singer, Ruth Unstead-Joss, Julie Wade, Ben W. Mol, Tim Draycott, Graeme MacLennan, Lucy MacKillop, Paul Mannix, Diana Elbourne, Henk Groen, Edile Murdoch, Sarah Stock, Sumita Bhuiya, Soumendra Nallapeta, Emma Dooks, Sophie Packham, Diane Whitehouse, Chloe O’Hara, Connie Weston, Diane Mellers, Lesley Brittain, Phern Adams, Rebecca Shakespeare, Sudeepthi Kakara, Janet Wright, Amal Mighell, Jennifer Syson, Kari Swettenham, Jenny Eedle, Shaila Seraj, Maryanne Bray, Bethan Jones, Claire Bertorelli, Hannah Ritter, Vikki Keeping, Janet Cresswell, Mary Kelly-Baxter, Li-Shan Yeoh, Shailly Sahu Bhansali, Vandana More, Bini Ajay, Geraldine Upson, Danielle Hake, Diana Opoku, Emma Wayman, Natalia Cwiek, Stacy Tregellas, Nikki Lee, Lavinia Margarit, Joelle Pike, Kate Jones, Sophie-Mae Wheeler-Davies, Meena Ali, Indhuja Rajkumar, Ruth Habibi, Sarah Davies, Anangsha Kumar, Harinakshi Salian, Trudy Smith, Deepika Meneni, Hazel Alexander, Helen Harwood, Kerry Hebbron, Lynn Whitecross, Mary Hodgers, Shilpa Mahadasu, Nick Kametas, Yasmin Sana, Hayley Martin, Rebecca Jarman, Sophie Webster, Jyothi Rajeswary, Mandy Gill, Gabrielle Bambridge, Isabel Bradley, Kristina Sexton, Lola Oshodi, Cornelia Wiesender, Claire Dodd, Rupa Modi, Beverley Cowlishaw, Gina Mulheron, Magdalena Kierzenkowska, Molly Patterson, Patricia Amos, Sharon Marie Bates, Sharon Raper, Umber Agarwal, Ruth Cockerill, Amy Mahdi, Caroline Cunningham, Michelle Dower, Sian Andrews, Siobhan Holt, Carly Williams, Zora Castling, Linda Watkins, David Churchill, Ellmina McKenzie, Julie Icke, Laura Devison, Vinita Raheja, Angela Ayuk, Jessica Reynolds, Julie Wyton, Stacey Duffy, Kate Walker, Jane Cantliffe, Catriona Hussain, Carys Smith, Harriet Anderson, Lesley Hodgen, Karen Brackley, Nicki Martin, Fiona Walbridge, Rhea Hampton, Nia Jones, Patrick Bose, Catherine Young, Fidelma Lee, Rebecca Peart, Emma Tanton, Kat Rhead, Kristin Fiedler, Ruth Bowen, Stephy Mathen, Zainab Sarwar, Chloe Rishton, Chloe Scott, Jane Farey, Nisha Verasingam, Mel Rich, Annette Moreton, Catherine Bressington, Jennifer Pullen, Sara Burnard, Wendy Duberry, Madhuchanda Dey, Sharon Jones, Pauline Bird, Aarti Ullal, Eileen Walton, Ashleigh Price, Janet Scollen, Judith Ormonde, Kirsten Herdman, Lesley Hewitt, Lucy Rowland, Mandeep Singh, Sundararajah Raajkumar, Beena Saji, Asma Khalil, Alice Perry, Emily Marler, Ijeoma Imuzeze, Sophie Robinson, Jonathan Nelson, Kathryn McNamara, Carina Craig, Del Endersby, Jayne Wagstaff, Kate Robinson, Hannah Barnes, Jane Gavin, Jenny Myers, Kate Stanbury, Christine Hughes, Latha Vinayakarao, Louise Melson, Stephanie Grigsby, Susara Blunden, Melanie Griffin, Sarah Newell, Katharine Jane Thompson, Brittany Smart, Elizabeth Payne, Marie Pitchford, Rahila Khan, Sophia Stone, Ahmed Elgarhy, Emma Meadows, Marian Flynn-Batham, Nikky Passmore, Vivienne Cannons, Declan Symington, Alice Lewin, Hayley Tarft, Jessamine Hunt, Zoe Vowles, Maria Slaney, Rachel Woodcock, Alex Van der Meer, Tracey Benn, Ru Davies, Sophie Boyd, Gareth Waring, Jill Riches, Andrea Fenn, Aly Kimber, Susan Harrop, Daniel Stott, Amos Tetteh, Davide Casagrandi, Miriam Bourke, Eirini Vaikousi, Rita Sarquis, Morenike Folorunsho, Olivia Newth, Sarah Weist, Yaa Acheampong, Vidhya Ravikumar, Jemma Yorke, Vicki Atkinson, Shelly Wood, Tigist Mengistu, Robert Chadwick, Helen Haden, Lisa Richardson, Joanna Girling, Amy Barker, Andrea Day, Elaine Palmer, Louise Page, Millicent Nwandison, Osaeloke Osakwe, Philippe de Rosnay, Sana Usman, Susan Barnes, Grace Ryan, Komal Lal, Lauren Trepte, Samantha Steele, Jacqueline Tang, Harriet Pearson, Jo Ingham, Nicola Spark
Xanthohumol microbiome and signature in adults with Crohn’s disease (the XMaS trial): a protocol for a phase II triple-masked, placebo-controlled clinical trial
Blake O. Langley, Jennifer Joan Ryan, John Phipps, Lita Buttolph, Brenna Bray, Joseph E. Aslan, Thomas O. Metz, Jan F. Stevens, Ryan Bradley
Statistical analysis plan for the stepped wedge clinical trial Healing Right Way—enhancing rehabilitation services for Aboriginal Australians after brain injury
Elizabeth Armstrong, Tapan Rai, Deborah Hersh, Sandra Thompson, Juli Coffin, Natalie Ciccone, Leon Flicker, Dominique Cadilhac, Erin Godecke, Deborah Woods, Colleen Hayward, Graeme J. Hankey, Meaghan McAllister, Judith Katzenellenbogen
Analgesic efficacy and safety of nalbuphine versus morphine for perioperative tumor ablation: a randomized, controlled, multicenter trial
Youhua Xue, Zhengli Huang, Bingwei Cheng, Jie Sun, Haidong Zhu, Yuting Tang, Xiaoyan Wang
Enriched enrollment randomized double-blind placebo-controlled cross-over trial with phenytoin cream in painful chronic idiopathic axonal polyneuropathy (EPHENE): a study protocol
David J. Kopsky, Ruben P. A. van Eijk, Janna K. Warendorf, Jan M. Keppel Hesselink, Nicolette C. Notermans, Alexander F. J. E. Vrancken
Interactions in the 2×2×2 factorial randomised clinical STEPCARE trial and the potential effects on conclusions: a protocol for a simulation study
Markus Harboe Olsen, Aksel Karl Georg Jensen, Josef Dankiewicz, Markus B. Skrifvars, Matti Reinikainen, Marjaana Tiainen, Manoj Saxena, Anders Aneman, Christian Gluud, Susann Ullén, Niklas Nielsen, Janus Christian Jakobsen
Effect of vitamin D supplementation on brain waves, behavioral performance, nitric oxide, malondialdehyde, and high-sensitivity C-reactive protein in children with attention deficit/hyperactivity disorder: study protocol for a randomized clinical trial
Abbas Ali Sangouni, Hamid Mirhosseini, Mahdieh Hosseinzadeh
Efficacy of Emotionally Focused Therapy among Spanish-speaking couples: study protocol of a randomized clinical trial in Argentina, Costa Rica, Guatemala, Mexico, and Spain
Martiño Rodríguez-Gonzalez, Shayne Anderson, Alfonso Osorio, Marie-France Lafontaine, Paul S. Greenman, María Calatrava, Dania Andrade, Ragan Lybbert, Pilar Martínez-Diaz, Patrick Steffen, Jokin de Irala, Jonathan Sandberg
Personalized Disease Prevention (PDP): study protocol for a cluster-randomized clinical trial
Glen B. Taksler, Phuc Le, Bo Hu, Jay Alberts, Allen J. Flynn, Michael B. Rothberg
Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial)
Hanne Massonet, Ann Goeleven, Leen Van den Steen, Alice Vergauwen, Margot Baudelet, Gilles Van Haesendonck, Olivier Vanderveken, Heleen Bollen, Lisette van der Molen, Fréderic Duprez, Peter Tomassen, Sandra Nuyts, Gwen Van Nuffelen
Cognitive Behavioural Therapy to Optimize Post-Operative Fracture Recovery (COPE): protocol for a randomized controlled trial
Jason W. Busse, Sheila Sprague, Gina Del Fabbro, Paula McKay, Lehana Thabane, Randi E. McCabe, Matilda Nowakowski, Christy Shibu, Natalie Fleming, Herman Johal, Gerard Slobogean, Roman M. Natoli, I. Leah Gitajn, Prism Schneider, P. J. Devereaux, Emil H. Schemitsch, Mohit Bhandari, Gordon H. Guyatt, Eleni Hapidou, Delia Chiaramonte, Henrick Kehlet, James Khan, Aaron Johnson, Diane Heels-Ansdell, Sofia Bzovsky, Brad A. Petrisor, Dale Williams, Bill Ristevski, Jamal Al-Asiri, Matthew Denkers, Kris Rajaratnam, Jodi L. Gallant, Sarah MacRae, Kaitlyn Pusztai, Sara Renaud, Nicki Johal, Steven Papp, Karl-Andre Lalonde, Bradley Meulenkamp, Allan Liew, Manisha Mistry, Braden Gammon, Wade Gofton, Geoffrey Wilkin, Melanie Dodd-Moher, David Puskas, Travis Marion, Tina Lefrancois, Jubin Payandeh, Claude Cullinan, Tracy Wilson, Kurt Droll, Michael Riediger, Rabail Siddiqui, Shalyn Littlefield, Simrun Chahal, Paige Wagar, Prism S. Schneider, Tosin Ogunleye, Tanya Cherppukaran, Karin Lienhard, Nicholas Smith, Sarah Anthony, Krista Butt, LaShann Selby, Murali Kovvur, Joshua Lawrence, Skyler Sampson, Kristin Turner, Todd Jaeblon, Haley K. Demyanovich, Sneh Talwar, Caroline Benzel, Theresa Chockbengboun, Devin Mullin, Logan Bateman, Melanie Christian, Peter DePalo, Paul J. Appleton, John J. Wixted, Edward K. Rodriguez, Michael F. McTague, Katiri Wagner, Kristina Brackpool, Kate Hegermiller, Nhi Nguyen, Courteney Fentz, Maricela Diaz, Jill Niceley, Kyle J. Jeray, Thomas M. Schaller, Michael S. Sridhar, John D. Adams, Richard W. Gurich Jr., Stephanie L. Tanner, Kyle Adams, Michelle Donohue, Emily Bray, Calleigh Brignull, Harper Sprouse
Comparison of different concentrations of a povidone iodine-diluted sitz bath in the prevention of perianal infection in patients undergoing chemotherapy for hematological malignancy: study protocol for a randomized controlled trial
Yuqin Luo, Yingli Wang, Mei Yang, Ting Luo, Fengjiao Chen, Yamei Leng, Li Zhou, Jinbo Fang, Yuan Li, Chen Chen
Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i): protocol for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice
Tessa Reardon, Obioha C. Ukoumunne, Mara Violato, Susan Ball, Paul Brown, Tamsin Ford, Alastair Gray, Claire Hill, Bec Jasper, Michael Larkin, Ian Macdonald, Fran Morgan, Jack Pollard, Michelle Sancho, Falko F. Sniehotta, Susan H. Spence, Paul Stallard, Jason Stainer, Lucy Taylor, Victoria Williamson, Emily Day, Jennifer Fisk, Iheoma Green, Gemma Halliday, Ciara Hennigan, Samantha Pearcey, Olly Robertson, Cathy Creswell
High-dose Intensity-modulated proton therapy versus Standard-dose Intensity-modulated RadIation therapy for esophageal squamous cell carcinoma (HI-SIRI): study protocol for a randomized controlled clinical trial
Chawalit Lertbutsayanukul, Sarin Kitpanit, Danita Kannarunimit, Chakkapong Chakkabat, Sornjarod Oonsiri, Kullathorn Thephamongkhol, Putipun Puataweepong, Kanyarat Katanyoo, Jirasak Sukhaboon, Chokaew Tovanabut, Sirikanya Chongsathientham, Pornravee Treeratsapanich, Jirarat Soonthornrak, Anussara Prayongrat
Efficacy and safety of Jiu-Wei-Xi-Feng granules for treating tic disorders in children: study protocol for a randomized controlled equivalence trial
Sheng-xuan Guo, Rui-ben Li, Si-yuan Hu, Qiu-han Cai, Cheng-liang Zhong, Rui-min Hao
Brief internet-delivered cognitive-behavioural intervention for children and adolescents with symptoms of anxiety and depression during the COVID-19 pandemic: a randomised controlled trial protocol
Caio Borba Casella, Pedro Fonseca Zuccolo, Luisa Sugaya, Aline Santana de Souza, Luara Otoch, Fernanda Alarcão, Wagner Gurgel, Daniel Fatori, Guilherme V. Polanczyk
The effects of laparoscopic Roux-en-Y gastric bypass and one-anastomosis gastric bypass on glycemic control and remission of type 2 diabetes mellitus: study protocol for a multi-center randomized controlled trial (the DIABAR-trial)
A. van Rijswijk, N. van Olst, A. S. Meijnikman, Y. I. Z. Acherman, S. C. Bruin, A. W. van de Laar, C. C. van Olden, O. Aydin, H. Borger, U. H. W. Beuers, H. Herrema, J. Verheij, J. A. Apers, F. Bäckhed, V. E. A. Gerdes, M. Nieuwdorp, L. M. de Brauw
Use of a real-time risk-prediction model to identify pediatric patients at risk for thromboembolic events: study protocol for the Children’s Likelihood Of Thrombosis (CLOT) trial
Shannon C. Walker, Benjamin French, Ryan Moore, Henry J. Domenico, Jonathan P. Wanderer, Sreenivasa Balla, C. Buddy Creech, Daniel W. Byrne, Allison P. Wheeler
Smartphone-assisted guided self-help cognitive behavioral therapy for young people with distressing voices (SmartVoices): study protocol for a randomized controlled trial
Marialuisa Cavelti, Janko M. Kaeser, Stefan Lerch, Stephanie Bauer, Markus Moessner, Thomas Berger, Mark Hayward, Michael Kaess
The use of 3D ceramic block graft compared with autogenous block graft for rehabilitation of the atrophic maxilla: a randomized controlled clinical trial
Carolina Mendonça de Almeida Malzoni, Victor Gonçalves, Juliana Possari, Elcio Marcantonio Junior
Clinical impact of cardiac magnetic resonance in patients with suspected coronary artery disease associated with chronic kidney disease (AQUAMARINE-CKD study): study protocol for a randomized controlled trial
Teruo Noguchi, Hideki Ota, Naoya Matsumoto, Yoshiaki Morita, Akira Oshita, Eiji Kawasaki, Tomohiro Kawasaki, Kensuke Moriwaki, Shingo Kato, Kazuki Fukui, Tomoya Hoshi, Hiroaki Watabe, Tomoaki Kanaya, Yasuhide Asaumi, Yu Kataoka, Fumiyuki Otsuka, Kensuke Takagi, Shuichi Yoneda, Kenichiro Sawada, Takamasa Iwai, Hideo Matama, Satoshi Honda, Masashi Fujino, Hiroyuki Miura, Kunihiro Nishimura, Kei Takase
A practical guide to implementing a successful social media recruitment strategy: lessons from the Eczema Monitoring Online trial
Arabella Baker, Eleanor J. Mitchell, Kim S. Thomas
VoiceS: voice quality after transoral CO2 laser surgery versus single vocal cord irradiation for unilateral stage 0 and I glottic larynx cancer—a randomized phase III trial
Philipp Reinhardt, Roland Giger, Eberhard Seifert, Mohamed Shelan, Elena Riggenbach, Dario Terribilini, Andreas Joosten, Daniel H. Schanne, Daniel M. Aebersold, Peter Manser, Matthias S. Dettmer, Christian Simon, Esat M. Ozsahin, Raphaël Moeckli, Andreas Limacher, Francesca Caparrotti, Deepa Nair, Jean Bourhis, Martina A. Broglie, Abrahim Al-Mamgani, Olgun Elicin
Efficacy of platelet-rich plasma impregnation for unidirectional porous β-tricalcium phosphate in lateral lumbar interbody fusion: study protocol for a prospective controlled trial
Kosuke Sato, Toru Funayama, Hiroshi Noguchi, Tomoyuki Asada, Mamoru Kono, Fumihiko Eto, Yosuke Shibao, Kosei Miura, Naoya Kikuchi, Tomokazu Yoshioka, Hiroshi Takahashi, Masao Koda, Masashi Yamazaki
Smartphone-RCCT: an online repository of randomized controlled clinical trials of smartphone applications for chronic conditions
Jürgen Barth, Jiani Wang, Jesus Lopez-Alcalde, Christoph Kramm, Daniel Pach, Noelia Álvarez-Díaz, Eulàlia Grifol-Clar, Claudia M. Witt
A protocol for developing core outcome sets for laparoscopic hiatal hernia repair
Xiaoli Liu, Qiuyue Ma, Jie Chen, Huiqi Yang
Implantable collamer lens implantation (ICL) versus small incision lenticule extraction (SMILE) in low to moderate myopia: study protocol for a randomized, non-inferiority trial
Kangjun Li, Zheng Wang, Ming X. Wang
Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial
Russell J. McCulloh, Paul M. Darden, Jessica Snowden, Songthip Ounpraseuth, Jeannette Lee, Martina Clarke, Sophia R. Newcomer, Linda Fu, DeAnn Hubberd, Jaime Baldner, Maryam Garza, Ellen Kerns
Stimulation of the Tibial nerve Repetitively to Improve Incontinence in Parkinson’s Electronically (STRIPE trial): a randomised control trial of tibial nerve stimulation for bladder symptoms in Parkinson’s disease using a self-contained wearable device
Matthew D. Smith, Emma Tenison, Marcus J. Drake, Yoav Ben-Shlomo, Emily J. Henderson
A nationwide randomized controlled trial on additional treatment for isolated local pancreatic cancer recurrence using stereotactic body radiation therapy (ARCADE)
I. W. J. M. van Goor, L. A. Daamen, M. G. Besselink, A. M. E. Bruynzeel, O. R. Busch, G. A. Cirkel, B. Groot Koerkamp, N. Haj Mohammed, H. D. Heerkens, H. W. M. van Laarhoven, G. J. Meijer, J. Nuyttens, H. C. van Santvoort, G. van Tienhoven, H. M. Verkooijen, J. W. Wilmink, I. Q. Molenaar, M. P. W. Intven
High-definition transcranial direct current stimulation (HD-tDCS) as augmentation therapy in late-life depression (LLD) with suboptimal response to treatment—a study protocol for a double-blinded randomized sham-controlled trial
Sze Ting Joanna Ngan, Lap Kei Chan, Wai Chi Chan, Linda Chiu Wa Lam, Wan Kei Li, Kelvin Lim, Ego Or, Pui Fai Pang, Ting Keung Poon, Mei Cheung Mimi Wong, Ying King Anna Wu, Pak Wing Calvin Cheng
A multicenter, randomized controlled trial to compare the effectiveness of STARC-SUD (Skills Training in Affect Regulation – a Culture-sensitive approach) versus treatment as usual in trauma-exposed refugees with substance use problems
Ingo Schäfer, Philipp Hiller, Sascha Milin, Annett Lotzin
Treatment of nonarteritic anterior ischemic optic neuropathy with an endothelin antagonist: ENDOTHELION (ENDOTHELin antagonist receptor in Ischemic Optic Neuropathy)—a multicentre randomised controlled trial protocol
Christophe Chiquet, Catherine Vignal, Philippe Gohier, Emmanuel Heron, Gilles Thuret, Marie Bénédicte Rougier, Audrey Lehmann, Laurent Flet, Jean-Louis Quesada, Mathieu Roustit, Dan Milea, Jean-Louis Pepin
Enteral versus parental nutrition after pancreaticoduodenectomy under enhanced recovery after surgery protocol: study protocol for a multicenter, open-label randomized controlled trial (ENE-PAN trial)
Yoshinori Takeda, Yoshihiro Mise, Yoji Kishi, Hiroyuki Sugo, Yusuke Kyoden, Kiyoshi Hasegawa, Yu Takahashi, Akio Saiura
Evaluation of cultural competency in a South African cluster randomised controlled trial: lessons learned for trial reporting standards
Nandi Louise Siegfried, Sally Hopewell, Lesley-Ann Erasmus-Claassen, Bronwyn Myers
Correction: An online parenting intervention to prevent affective disorders in high-risk adolescents: the PIPA trial protocol
C. Connor, M. B. H. Yap, J. Warwick, M. Birchwood, N. De Valliere, J. Madan, G. A. Melvin, E. Padfeld, P. Patterson, S. Petrou, K. Raynes, S. Stewart-Brown, A. Thompson
Anastomotic leak after minimally invasive anterior resection for rectal cancer with high versus low ligation of the inferior mesenteric artery: a study protocol for a multicentre randomized clinical trial
Soo Young Lee, Sohyun Kim, Gyung Mo Son, Hye Jin Kim, Soo Yeun Park, Jun Seok Park, Chang Hyun Kim, Gi Won Ha, Kyung-Ha Lee, Jin Soo Kim, Ki Beom Bae, Sung Uk Bae, Sung Il Kang
Telehealth exercise to Improve Physical function and frailty in patients with multiple myeloma treated with autologous hematopoietic Stem cell transplantation (TIPS): protocol of a randomized controlled trial
Kyuwan Lee, Nitya Nathwani, Justin Shamunee, Lanie Lindenfeld, F. Lennie Wong, Amrita Krishnan, Saro Armenian
Effect of early stellate ganglion block in cerebral vasospasm after aneurysmal subarachnoid hemorrhage (BLOCK-CVS): study protocol for a randomized controlled trial
Longnian Jing, Youxuan Wu, Fa Liang, Minyu Jian, Yang Bai, Yunzhen Wang, Haiyang Liu, Anxin Wang, Xiaolin Chen, Ruquan Han
Self-management strategies and multicomponent training to mitigate the effects of the interruption of physical exercise programmes in the pandemic context on functionality, sedentary behaviour, physical capacity, mental health, body composition and quality of life in older adults: a blinded randomized controlled study protocol
Ana Claudia Silva Farche, Gabriela Cassemiliano, Paulo Giusti Rossi, Bianca Ferdin Carnavale, Stefany Lee, Laura Bonome Message, Vinícius Ramon da Silva Santos, Juliana Hotta Ansai, Eduardo Ferriolli, Natália Duarte Pereira, Guillermo Rúben Oviedo, Myriam Guerra-Balic, Maria Giné-Garriga, Marina Araújo Lopes, Anielle Cristhine de Medeiros Takahashi
Detailed statistical analysis plan for a randomised controlled trial of the effects of a modified muscle sparing posterior technique (SPAIRE) in hip hemiarthroplasty for displaced intracapsular fractures on post-operative function compared to a standard lateral approach: HemiSPAIRE
Susan Ball, Amy McAndrew, Alex Aylward, Emma Cockcroft, Elizabeth Gordon, Alison Kerridge, Sarah Morgan-Trimmer, Roy Powell, Anna Price, Shelley Rhodes, Andrew J. Timperley, Jayden van Horik, Robert Wickins, John Charity
Does additional extracorporeal shock wave therapy improve the effect of isolated percutaneous radiofrequency coblation in patients with insertional Achilles tendinopathy? Study protocol for a randomized controlled clinical trial
Yu-Jie Song, Wen-Kai Xuan, Ying-Hui Hua
Swedish trial on embolization of middle meningeal artery versus surgical evacuation in chronic subdural hematoma (SWEMMA)—a national 12-month multi-center randomized controlled superiority trial with parallel group assignment, open treatment allocation and blinded clinical outcome assessment
Mattias Drake, Teresa Ullberg, Henrietta Nittby, Niklas Marklund, Johan Wassélius
Conducting a supportive oncology clinical trial during the COVID-19 pandemic: challenges and strategies
Jie Deng, John N. Lukens, Joy C. Cohn, Erin McMenamin, Barbara Murphy, Bryan A. Spinelli, Niya Murphy, Alicia K. Steinmetz, Megan A. Landriau, Alexander Lin
Intensified tuberculosis treatment to reduce the mortality of HIV-infected and uninfected patients with tuberculosis meningitis (INTENSE-TBM): study protocol for a phase III randomized controlled trial
Thomas Maitre, Maryline Bonnet, Alexandra Calmy, Mihaja Raberahona, Rivonirina Andry Rakotoarivelo, Niaina Rakotosamimanana, Juan Ambrosioni, José M. Miró, Pierre Debeaudrap, Conrad Muzoora, Angharad Davis, Graeme Meintjes, Sean Wasserman, Robert Wilkinson, Serge Eholié, Frédéric Ello Nogbou, Maria-Camilla Calvo-Cortes, Corine Chazallon, Vanessa Machault, Xavier Anglaret, Fabrice Bonnet
Effects of early home-based strength and sensory-motor training after total hip arthroplasty: study protocol for a multicenter randomized controlled trial
Pika Krištof Mirt, Vojko Strojnik, Gregor Kavčič, Rihard Trebše
The effect of mHealth-based exercise on Insulin Sensitivity for patients with Hepatocellular carcinoma and insulin resistance (mISH): protocol of a randomized controlled trial
Seung Mi Yeo, Joo Hyun Oh, Hee Ju Yu, Dong Hyun Sinn, Ji Hye Hwang
Inclusion of progression criteria in external randomised pilot trials: a cross-sectional study of funding applications submitted to the NIHR Research for Patient Benefit Programme
Katie Mellor, James Harwood, Jennie Hejdenberg, Ben Morgan, Susan J. Dutton, Sally Hopewell
Phase II/III trial of hyperimmune anti-COVID-19 intravenous immunoglobulin (C-IVIG) therapy in severe COVID-19 patients: study protocol for a randomized controlled trial
Shaukat Ali, Elisha Shalim, Farah Farhan, Fatima Anjum, Ayesha Ali, Syed Muneeb Uddin, Faisal Shahab, Mustafa Haider, Iqra Ahmed, Mir Rashid Ali, Sadaf Khan, Sadia Rao, Kabeer Guriro, Saud Elahi, Muhammad Ali, Tehreem Mushtaq, Muneeba Ahsan Sayeed, Sheikh Muhammad Muhaymin, Shoba Luxmi, Saifullah, Saeed Qureshi
AGI grade-guided chaiqin chengqi decoction treatment for predicted moderately severe and severe acute pancreatitis (CAP trial): study protocol of a randomised, double-blind, placebo-controlled, parallel-group, pragmatic clinical trial
Zhiyao Chen, Xiaonan Yang, Jia Guo, Tao Jin, Ziqi Lin, Ping Zhu, Jing Li, Ling Li, Xin Sun, Dan Du, Kun Jiang, Yanqiu He, Fei Cai, Lan Li, Cheng Hu, Qingyuan Tan, Wei Huang, Lihui Deng, Qing Xia
Functional imaging-guided carbon ion irradiation with simultaneous integrated boost for localized prostate cancer: study protocol for a phase II randomized controlled clinical trial
Wei Hu, Ping Li, Zhengshan Hong, Xiaomao Guo, Yulei Pei, Zhenshan Zhang, Qing Zhang
Brief Educational Workshops in Secondary Schools Trial (BESST): protocol for a school-based cluster randomised controlled trial of open-access psychological workshop programme for 16–18-year-olds
Stephen Lisk, Ben Carter, Kirsty James, Paul Stallard, Jessica Deighton, Jynna Yarrum, Peter Fonagy, Crispin Day, Sarah Byford, James Shearer, Timothy Weaver, Irene Sclare, Claire Evans, Maria Farrelly, Pin-Cheng Ho, June Brown
The effectiveness of a tablet-based video game that stimulates cognitive, emotional, and social skills in developing academic skills among preschoolers: study protocol for a randomized controlled trial
Cristian A. Rojas-Barahona, Jorge Gaete, Mauricio Véliz, Ramón D. Castillo, Saray Ramírez, Ricardo Araya
The Workwell trial: protocol for the process evaluation of a randomised controlled trial of job retention vocational rehabilitation for employed people with inflammatory arthritis
Alison Hammond, Kathryn A. Radford, Angela Ching, Yeliz Prior, Rachel O’Brien, Sarah Woodbridge, June Culley, Jennifer Parker, Paula Holland
Correction: G-CuP: the effect of a forced oral glucose intake on alcohol craving and mesolimbic cue reactivity in alcohol dependence—study protocol of a randomized, double-blind, placebo-controlled crossover study
Lea Wetzel, Madeleine Pourbaix, Alisa Riegler, Anna-Maria Pfeifer, Iris Reinhard, Sabine Hofmann, Sabine Vollstädt-Klein, Falk Kiefer, Wolfgang Sommer, Jan Malte Bumb, Patrick Bach, Anne Koopmann
Efficacy of belimumab combined with rituximab in severe systemic lupus erythematosus: study protocol for the phase 3, multicenter, randomized, open-label Synbiose 2 trial
Mieke van Schaik, Eline J. Arends, Darius Soonawala, Ellen van Ommen, Karina de Leeuw, Maarten Limper, Pieter van Paassen, Tom W. J. Huizinga, René E. M. Toes, Cees van Kooten, Joris I. Rotmans, Ton J. Rabelink, Y. K. Onno Teng
Effectiveness of Anapana, Body scan and Metta meditation techniques on chronic neck and shoulder region pain and disability in adult patients in Sri Lanka: study protocol for a cluster clinic-level randomised controlled trial
Aranjan Lionel Karunanayake, Emma Solomon-Moore, Nikki Coghill
Family behavior theory-based intervention via mobile messaging to improve oral health of adolescents: study protocol for a cluster randomized controlled trial
Pei Liu, May Chun Mei Wong, Gillian Hiu Man Lee, Cynthia Kar Yung Yiu, Edward Chin Man Lo
A randomised controlled trial to compare clinical and cost-effectiveness of an online parent-led treatment for child anxiety problems with usual care in the context of COVID-19 delivered in Child and Adolescent Mental Health Services in the UK (Co-CAT): a study protocol for a randomised controlled trial
Lucy Taylor, Sophie Giles, Sophie Howitt, Zoe Ryan, Emma Brooks, Lucy Radley, Abigail Thomson, Emily Whitaker, Fauzia Knight, Claire Hill, Mara Violato, Polly Waite, Vanessa Raymont, Ly-Mee Yu, Victoria Harris, Nicola Williams, Cathy Creswell
Protocol for the development of an international Core Outcome Set for treatment trials in adults with epilepsy: the EPilepsy outcome Set for Effectiveness Trials Project (EPSET)
James W. Mitchell, Adam Noble, Gus Baker, Rachel Batchelor, Francesco Brigo, Jakob Christensen, Jacqueline French, Antonio Gil-Nagel, Alla Guekht, Nathalie Jette, Reetta Kälviäinen, John Paul Leach, Melissa Maguire, Terence O’Brien, Felix Rosenow, Philippe Ryvlin, Phil Tittensor, Manjari Tripathi, Eugen Trinka, Samuel Wiebe, Paula R. Williamson, Tony Marson
How do trial teams plan for retention during the design stage of the trial? A scoping review protocol
Ellen Murphy, Katie Gillies, Frances Shiely
Effect of personalized perioperative blood pressure management on postoperative complications and mortality in high-risk patients having major abdominal surgery: protocol for a multicenter randomized trial (IMPROVE-multi)
Alina Bergholz, Agnes S. Meidert, Moritz Flick, Linda Krause, Eik Vettorazzi, Antonia Zapf, Frank M. Brunkhorst, Patrick Meybohm, Kai Zacharowski, Alexander Zarbock, Daniel I. Sessler, Karim Kouz, Bernd Saugel
Rotavirus vaccine clinical trials: a cross-sectional analysis of clinical trials registries
Duduzile Ndwandwe, Sinazo Runeyi, Lindi Mathebula, Charles Wiysonge
TRial to Assess Implementation of New research in a primary care Setting (TRAINS): study protocol for a pragmatic cluster randomised controlled trial of an educational intervention to promote asthma prescription uptake in general practitioner practices
Rami A. Alyami, Rebecca Simpson, Phillip Oliver, Steven A. Julious
Effect of comprehensive geriatric assessment for frail elderly patients operated for colorectal cancer—the colorectal cancer frailty study: study protocol for a randomized, controlled, multicentre trial
Maria Normann, Niklas Ekerstad, Eva Angenete, Mattias Prytz
Infraslow closed-loop brain training for anxiety and depression (ISAD): a protocol for a randomized, double-blind, sham-controlled pilot trial in adult females with internalizing disorders
Tyson M. Perez, Paul Glue, Divya B. Adhia, Muhammad S. Navid, Jiaxu Zeng, Peter Dillingham, Mark Smith, Imran K. Niazi, Calvin K. Young, Dirk De Ridder
Effect of intraoperative goal-directed fluid therapy on the postoperative brain edema in patients undergoing high-grade glioma resections: a study protocol of randomized control trial
Xiaoyuan Liu, Xingyue Zhang, Yifang Fan, Shu Li, Yuming Peng
Effect of different weekly frequencies of Chen-style Tai Chi in elders with chronic non-specific low back pain: study protocol for a randomised controlled trial
Ruihan Wan, Jian Shi, Kun Hu, Yafei Wang, Xue Jiang, Wangwang Yan, Mali Cao, Yuling Wang
Steroid treatment as anti-inflammatory and neuroprotective agent following out-of-hospital cardiac arrest: a randomized clinical trial
Laust Emil Roelsgaard Obling, Rasmus Paulin Beske, Sebastian Wiberg, Fredrik Folke, Jacob Eifer Moeller, Jesper Kjaergaard, Christian Hassager
Interpreting a Bayesian phase II futility clinical trial
Jonathan Beall, Christy Cassarly, Renee Martin
Surgical site infection after intracorporeal anastomosis for left-sided colon cancer: study protocol for a non-inferiority multicenter randomized controlled trial (STARS)
Liang He, Meng Li, Jia-xin Zhang, Wei-hua Tong, Yan Chen, Quan Wang
Efficacy and safety of Sri Lankan traditional medicine regimen for knee osteoarthritis: study protocol for an open-label, active comparator, randomized controlled trial
Himalee De Silva, Pathirage Kamal Perera, Saroj Jayasinghe, Shreenika De Silva Weliange
Immediate versus early (24-hours) urinary catheter removal after elective minimally invasive colonic resection: study protocol for a randomized, multicenter, non-inferiority trial
Corrado Pedrazzani, Isacco Montroni, Cristian Conti, Giulia Turri, Caterina Foppa, Michele Carvello, Giovanni Taffurelli, Giampaolo Ugolini, Antonino Spinelli
Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within a Trial
Victoria Shepherd, Fiona Wood, Katie Gillies, Adam Martin, Abby O’Connell, Kerenza Hood
Advancing cluster randomised trials in children’s therapy: a survey of the acceptability of trial behaviours to therapists and parents
Samantha Armitage, Tim Rapley, Lindsay Pennington, Jennifer McAnuff, Elaine McColl, Catherine Duff, Rob Brooks, Niina Kolehmainen
The effect of “moderately restricted carbohydrate” diet on gut microbiota composition and metabolic parameters in women with metabolic syndrome: a study protocol for a randomized controlled trial
Seyed Mohammad Mousavi, Hanieh-Sadat Ejtahed, Hanieh Malmir, Seyed Davar Siadat, Shirin Hasani-Ranjbar, Bagher Larijani, Ahmad Esmaillzadeh
Dimensional changes of peri-implant tissue following immediate flapless implant placement and provisionalization with or without xenograft in the anterior maxilla: a study protocol for a randomized controlled trial
Mehrnoush MeshkatAlsadat, Ali Hassani, Tahereh Bitaraf, Salar Chaychi Salmasi
Effectiveness of intensive perioperative nutrition therapy among adults undergoing gastrointestinal and oncological surgery in a public hospital: study protocol for a pragmatic randomized control trial
A’ishah Zafirah Abdul A’zim, Zalina Abu Zaid, Barakatun Nisak Mohd Yusof, Mohd Faisal Jabar, Aainaa Syarfa Mohd Shahar
Exploring the effects of a combined exercise programme on pain and fatigue outcomes in people with systemic sclerosis: study protocol for a large European multi-centre randomised controlled trial
Alexandros Mitropoulos, Carina Boström, Malin Mattsson, Evangelia Kouidi, Theodoros Dimitroulas, Sophie I. E. Liem, Theodora P. M. Vliet Vlieland, Jeska K. de Vries-Bouwstra, Søren Jacobsen, Giovanna Cuomo, Mohammed Akil, Markos Klonizakis
Comparison of intermittent screening (using ultra-sensitive malaria rapid diagnostic test) and treatment (using a newly registered antimalarial pyronaridine-artesunate—PYRAMAX®) to standard intermittent preventive treatment with sulfadoxine-pyrimethamine for the prevention of malaria in pregnant women living in endemic areas: ULTRAPYRAPREG
Vivi Maketa, Japhet Kabalu, Melissa Kabena, Flory Luzolo, Hypolite Muhindo-Mavoko, Henk D. F. H. Schallig, Kassoum Kayentao, Petra F. Mens, Pascal Lutumba, Halidou Tinto
Efficacy and cerebral mechanism of acupuncture and moxibustion for treating primary dysmenorrhea: study protocol for a randomized controlled clinical trial
Xiaohui Dong, Jie Yang, Wei Wei, Ling Chen, Menghua Su, Aijia Li, Xiaoli Guo, Liying Liu, Shenghong Li, Siyi Yu, Fang Zeng
A comparison of cognitive behavioral therapy for insomnia to standard of care in an outpatient substance use disorder clinic embedded within a therapeutic community: a RE-AIM framework evaluation
Traci J. Speed, Lisa Hanks, Gavin Turner, Evelyn Gurule, Alexandra Kearson, Luis Buenaver, Michael T. Smith, Denis Antoine
Commentary: an industry perspective on the importance of incorporating participant voice before, during, and after clinical trials
N. Goodson, P. Wicks, C. Farina
Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression
Christopher L. Drake, David A. Kalmbach, Philip Cheng, Brian K. Ahmedani, Edward L. Peterson, Christine L. M. Joseph, Thomas Roth, Kelley M. Kidwell, Chaewon Sagong
Silver-coated versus uncoated locking plates in subjects with fractures of the distal tibia: a randomized, subject and observer-blinded, multi-center non-inferiority study
S. Schoder, M. Lafuente, V. Alt
Prophylactic surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC CO2) versus standard surgery for gastric carcinoma at high risk of peritoneal carcinomatosis: short and long-term outcomes (GOETH STUDY)—a collaborative randomized controlled trial by ACOI, FONDAZIONE AIOM, SIC, SICE, and SICO
A. Di Giorgio, C. Gerardi, C. Abatini, G. Melotti, L. Bonavina, V. Torri, F. Santullo, S. Garattini, M. De Luca, Erica Rulli, Eliana Rulli, F. Pacelli
Predictors of participants’ retention—socioeconomic factors or nonadherence: insights from a urological clinical prospective study
Allison J. Wheeler, Harshit Garg, Dharam Kaushik, Ahmed Mansour, Deepak Pruthi, Michael A. Liss
Group psychoeducation for persons with bipolar disorder in Rwanda: a study protocol for a randomized controlled trial
E. Musoni-Rwililiza, C. J. Arnbjerg, C. Murekatete, J. Carlsson, P. Kallestrup, D. Gishoma
The effectiveness of using virtual reality technology for perioperative anxiety among adults undergoing elective surgery: a randomised controlled trial protocol
Salihah Asiri, Michelle Guilhermino, Jed Duff
Testing an attachment- and trauma-informed intervention approach for parents and young children after interparental violence: protocol for a randomized controlled trial
Sabine van der Asdonk, Ashwina R. Kesarlal, Carlo Schuengel, Nina Draaisma, Carlijn de Roos, Karine Zuidgeest, Ralph C. A. Rippe, Lenneke R. A. Alink
Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial—the OPERA study
Maarten Moens, Lisa Goudman, Dominique Van de Velde, Lode Godderis, Koen Putman, Jonas Callens, Olivia Lavreysen, Dries Ceulemans, Laurence Leysen, Jean-Pierre Van Buyten, Iris Smet, Ali Jerjir, Bart Bryon, Mark Plazier, Vincent Raymaekers, Sam Schelfout, Erwin Crombez, Tom Theys, Anaïs Van Hoylandt, Philippe De Vloo, Bart Nuttin, Lieven Annemans, Elien Van der Gucht, Anneleen Leyman, Ann De Smedt
Symptom-driven inhaled corticosteroid/long-acting beta-agonist therapy for adult patients with asthma who are non-adherent to daily maintenance inhalers: a study protocol for a pragmatic randomized controlled trial
James G. Krings, Kaitlyn M. Wojcik, Vanessa Chen, Tejas C. Sekhar, Kelly Harris, Abigail Zulich, Kaharu Sumino, Ross Brownson, Eric Lenze, Mario Castro
ANDA-Evaluating Facilitated Feedback Enhancement - a Cluster randomised Trial (ANDA-EFFECT): protocol for a cluster randomised trial of audit feedback augmented with education and support, compared to feedback alone, on acceptability, utility and health outcomes in diabetes centres in Australia
Matthew Quigley, Arul Earnest, Sofianos Andrikopoulos, Natalie Wischer, Sally Green, Sophia Zoungas
Short-term clinical effectiveness of 5% lidocaine patch after arthroscopic rotator cuff repair: study protocol for a randomized, double-blinded, placebo-controlled clinical trial
Yufan Qian, Yingjie Xu, Xiaohong Jin, Jiong Jiong Guo
Lithium carbonate in amyotrophic lateral sclerosis patients homozygous for the C-allele at SNP rs12608932 in UNC13A: protocol for a confirmatory, randomized, group-sequential, event-driven, double-blind, placebo-controlled trial
Sean W. Willemse, Kit C. B. Roes, Philip Van Damme, Orla Hardiman, Caroline Ingre, Monica Povedano, Naomi R. Wray, Marleen Gijzen, Mirjam S. de Pagter, Koen C. Demaegd, Annemarie F. C. Janse, Roel G. Vink, Boudewijn T. H. M. Sleutjes, Adriano Chiò, Philippe Corcia, Evy Reviers, Ammar Al-Chalabi, Matthew C. Kiernan, Leonard H. van den Berg, Michael A. van Es, Ruben P. A. van Eijk
Anaesthetic efficacy and influence on cardiovascular parameters change of intraosseous computerised anaesthesia versus inferior alveolar nerve block anaesthesia in acute irreversible pulpitis of mandibular molars: study protocol for a prospective randomised controlled trial
Amany Laham, Roselyne Clouet, Gilles Amador del Valle, Alexis Gaudin, Tony Prud’homme
The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury: study protocol adaptations during the COVID-19 pandemic for a multisite implementation-effectiveness cluster randomized controlled trial
Julia Velonjara, Brianna Mills, Silvia Lujan, Gustavo Petroni, Michael J. Bell, Nahuel Guadagnoli, Charles Mock, James P. Hughes, Monica S. Vavilala, Ali Rowhani-Rahbar, Mariela Alassia, Silvina Abalos, Natalia Gómez Arriola, Pablo Castellani, Sandra Chuchuy, Karina Cinquegrani, Carlos Dávila, Adriana Diettes, Gabriela López Cruz, Alejandro Mansur, Ivana Marinelli, Paula Medici, Silvia Oliveri, Matías Penazzi, Graciela Romero, Ariel Segado, Alejandra Depetris, Daniel Giordano, Linda Ng Boyle, Megan Moore, Bryan Weiner, Karen Segar, Jin Wang, Shyam J. Deshpande, Chelsea Hicks, Janessa Graves
A novel Bayesian adaptive design incorporating both primary and secondary endpoints for randomized IIB chemoprevention study of women at increased risk for breast cancer
Byron J. Gajewski, Bruce F. Kimler, Devin C. Koestler, Dinesh Pal Mudaranthakam, Kate Young, Carol J. Fabian
Full-endoscopic versus conventional microsurgical therapy of lumbar disc herniation: a prospective, controlled, single-center, comprehensive cohort trial (FEMT-LDH trial)
Babak Saravi, Sara Ülkümen, Sebastien Couillard-Despres, Frank Hassel, Gernot Lang
An online behavior change intervention to promote physical activity in adults with asthma: study protocol for a multicenter randomized controlled trial
Joice Mara de Oliveira, Manuela Karloh, Thiago Sousa Matias, Graziele Besen Barbosa, Patricia Duarte Freitas, Celso R. F. Carvalho, Karina Couto Furlanetto
Efficacy and safety of remimazolam for non-obese patients during anesthetic induction in cardiac surgery: study protocol for a multicenter randomized trial
Hong Yu, Hong-Mei Liu, Ping Li, Hai Yu, Bin Liu, Peng Liang
The Diabetes teleMonitoring of patients in insulin Therapy (DiaMonT) trial: study protocol for a randomized controlled trial
Stine Hangaard, Thomas Kronborg, Ole Hejlesen, Tinna Björk Aradóttir, Anne Kaas, Henrik Bengtsson, Peter Vestergaard, Morten Hasselstrøm Jensen
An international, stepped wedge, cluster-randomized trial investigating the 0/1-h algorithm in suspected acute coronary syndrome in Asia: the rational of the DROP-Asian ACS study
Kenji Inoue, Jack Tan Wei Chieh, Lim Chiw Yeh, Shuo-Ju Chiang, Arintaya Phrommintikul, Pannipa Suwanasom, Sazzli Kasim, Bakhtiar Ahmad, Alzamani Mohammad Idrose, Farina Mohd Salleh, Shunsuke Oyamada, Yohei Hirano, Shohei Ouchi, Moriyuki Terakura, Naoyuki Yokoyama, Ken Kozuma, Mamoru Nanasato, Ryosuke Higuchi, Kazuhiko Yumoto, Tomoyuki Fukuzawa, Issei Shimada, Evangelos Giannitsis, Raphael Twerenbold, Tohru Minamino
Analysis of multiple-period group randomized trials: random coefficients model or repeated measures ANOVA?
Jonathan C. Moyer, Patrick J. Heagerty, David M. Murray
Safety and efficacy of direct cardiac shockwave therapy in patients with ischemic cardiomyopathy undergoing coronary artery bypass grafting (the CAST-HF trial): study protocol for a randomized controlled trial—an update
Felix Nägele, Leo Pölzl, Michael Graber, Jakob Hirsch, Agnes Mayr, Mathias Pamminger, Felix Troger, Markus Theurl, Michael Schreinlechner, Nikolay Sappler, Christian Dorfmüller, Martina Mitrovic, Hanno Ulmer, Michael Grimm, Can Gollmann-Tepeköylü, Johannes Holfeld
Cluster randomised control trial protocol for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FLUCARE)
Amrish Patel, Erika Sims, Jeanette Blacklock, Linda Birt, Veronica Bion, Allan Clark, Alys Griffiths, Cecile Guillard, Amber Hammond, Richard Holland, Andy Jones, Liz Jones, Thando Katangwe-Chigamba, Jennifer Pitcher, Po Ruby, Sion Scott, Adam P. Wagner, Saiqa Ahmed, Wasim Baqir, Luke Cook, Tony Dean, David Wright
Detailed statistical analysis plan for the neurological complications in endoscopic versus open radial artery harvest (NEO) randomised clinical trial
Christian L. Carranza, Martin Ballegaard, Mads U. Werner, Philip Hasbak, Andreas Kjaer, Klaus Kofoed, Markus Harboe Olsen, Christian Gluud, Janus Christian Jakobsen
Surrogate endpoints in trials: a call for better reporting
Oriana Ciani, Anthony M. Manyara, An-Wen Chan, Rod S. Taylor
Effect of remimazolam tosilate versus etomidate on hemodynamics in patients undergoing valve replacement surgery: study protocol for a randomized controlled trial
Bailong Hu, Haiyan Zhou, Xiaohua Zou, Li Tan, Tao Song, Lucas Zellmer, Xingyu Li
Pressure support and positive end-expiratory pressure versus T-piece during spontaneous breathing trial in difficult weaning from mechanical ventilation: study protocol for the SBT-ICU study
Mehdi Mezidi, Hodane Yonis, Louis Chauvelot, William Danjou, François Dhelft, Alwin Bazzani, Mehdi Girard, Laurent Bitker, Jean-Christophe Richard
Randomized controlled trial of an internet-based self-guided hand exercise program to improve hand function in people with systemic sclerosis: the Scleroderma Patient-centered Intervention Network Hand Exercise Program (SPIN-HAND) trial
Linda Kwakkenbos, Marie-Eve Carrier, Joep Welling, Brooke Levis, Alexander W. Levis, Maureen Sauve, Kimberly A. Turner, Lydia Tao, Kylene Aguila, Andrea Carboni-Jiménez, Mara Cañedo-Ayala, Sami Harb, Cornelia van den Ende, Marie Hudson, Ward van Breda, Christelle Nguyen, Isabelle Boutron, François Rannou, Brett D. Thombs, Luc Mouthon, Richard S. Henry, Susan J. Bartlett, Catherine Fortuné, Karen Gottesman, Geneviève Guillot, Laura K. Hummers, Amanda Lawrie-Jones, Vanessa L. Malcarne, Maureen D. Mayes, Warren R. Nielson, Michelle Richard, Shervin Assassi, Andrea Benedetti, Ghassan El-Baalbaki, Carolyn Ells, Kim Fligelstone, Tracy Frech, Amy Gietzen, Daphna Harel, Monique Hinchcliff, Sindhu R. Johnson, Maggie Larche, Catarina Leite, Karen Nielsen, Janet Pope, Tatiana Sofia, Anne A. Schouffoer, Maria E. Suarez-Almazor, Christian Agard, Nassim Ait Abdallah, Marc André, Elana J. Bernstein, Sabine Berthier, Lyne Bissonnette, Alessandra Bruns, Patricia Carreira, Marion Casadevall, Benjamin Chaigne, Lorinda Chung, Benjamin Crichi, Christopher Denton, Robyn Domsic, James V. Dunne, Bertrand Dunogue, Regina Fare, Dominique Farge-Bancel, Paul R. Fortin, Jessica Gordon, Brigitte Granel-Rey, Aurélien Guffroy, Genevieve Gyger, Eric Hachulla, Ariane L. Herrick, Sabrina Hoa, Alena Ikic, Niall Jones, Suzanne Kafaja, Nader Khalidi, Marc Lambert, David Launay, Yvonne C. Lee, Hélène Maillard, Nancy Maltez, Joanne Manning, Isabelle Marie, Maria Martin Lopez, Thierry Martin, Ariel Masetto, François Maurier, Arsene Mekinian, Sheila Melchor Díaz, Mandana Nikpour, Louis Olagne, Vincent Poindron, Susanna Proudman, Alexis Régent, Sébastien Rivière, David Robinson, Esther Rodríguez, Sophie Roux, Perrine Smets, Vincent Sobanski, Robert Spiera, Virginia Steen, Evelyn Sutton, Carter Thorne, John Varga, Pearce Wilcox, Marie-Nicole Discepola, Laury Montemurro, Elsa Lynn Nassar, Marieke Alexandra Neyer, Julia Nordlund, Nora Østbø, Sabrina Provencher
Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial
Huichen Zhu, Zhongxue Su, Xiaorong Huai, Caiyang Chen, Xiao Zhang, Jie Zhou, Diansan Su
Pre-incisional infiltration with ropivacaine plus dexamethasone palmitate emulsion for postoperative pain in patients undergoing craniotomy: study protocol for a prospective, randomized controlled trial
Wei Zhang, Chunzhao Li, Chunmei Zhao, Nan Ji, Fang Luo
Efficacy of the Digital Therapeutic sinCephalea in the prophylaxis of migraine in patients with episodic migraine: study protocol for a digital, randomized, open-label, standard treatment controlled trial
Torsten Schröder, Hanna C. B. Brudermann, Gianna Kühn, Christian Sina, Diamant Thaçi, Matthias Nitschke, Inke R. König
Exploring the consequences of food insecurity and harnessing the power of peer navigation and mHealth to reduce food insecurity and cardiometabolic comorbidities among persons with HIV: protocol for development and implementation trial of weCare/Secure
Amanda E. Tanner, Deepak Palakshappa, Caryn G. Morse, Lilli Mann-Jackson, Jorge Alonzo, Manuel Garcia, Elena Wright, Ajay Dharod, Scott Isom, Ana D. Sucaldito, Lucero Refugio Aviles, Scott D. Rhodes
Correction: Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial–a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial
Nathan R. Hill, Daniel Lasserson, Ben Thompson, Rafael Perera-Salazar, Jane Wolstenholme, Peter Bower, Thomas Blakeman, David Fitzmaurice, Paul Little, Gene Feder, Nadeem Qureshi, Maarten Taal, Jonathan Townend, Charles Ferro, Richard McManus, F. D. Richard Hobbs
Approaches to prioritising research for clinical trial networks: a scoping review
Rachael L. Morton, Haitham Tuffaha, Vendula Blaya-Novakova, Jenean Spencer, Carmel M. Hawley, Phil Peyton, Alisa Higgins, Julie Marsh, William J. Taylor, Sue Huckson, Amy Sillett, Kieran Schneemann, Anitha Balagurunanthan, Miranda Cumpston, Paul A. Scuffham, Paul Glasziou, Robert J. Simes
Effect of Tai Chi versus aerobic exercise on blood pressure in prehypertension patients (TCOBPP): a study protocol for a 12-month single-blind randomized controlled trial
Xinye Li, Yonghong Gao, Min Wu, Dawei Wei, Xingjiang Xiong, Yan Yang, Yuchen Jiang, Xiandu Pan, Ran Zhao, Fan Yang, Jiahao Sun, Shengjie Yang, Li Tian, Linqiang Ban, Xingye Li, Peifen Chang, Yanwei Xing
Effects of alpha-lipoic acid on sperm quality in patients with varicocele-related male infertility: study protocol for a randomized controlled clinical trial
Qi-Feng Zhang, Sheng Wang, Han Zhang, Qi-Li Liu, Yu Wei, Wei Deng, Chuang Wang, Bo Yang
Online Parent Training for The Initial Management of ADHD referrals (OPTIMA): the protocol for a randomised controlled trial of a digital parenting intervention implemented to support parents and children on a treatment waitlist
Katarzyna Kostyrka-Allchorne, Claire Ballard, Sarah Byford, Samuele Cortese, David Daley, Johnny Downs, Blandine French, Cristine Glazebrook, Kimberley Goldsmith, Charlotte L. Hall, Ellen Hedstrom, Hanna Kovshoff, Jana Kreppner, Nancy Lean, Kapil Sayal, James Shearer, Emily Simonoff, Margaret Thompson, Edmund J. S. Sonuga-Barke
Considerations when introducing electronic patient-reported outcome data capture in multicentre oncology randomised controlled trials
Lara Philipps, Stephanie Foster, Deborah Gardiner, Alexa Gillman, Joanne Haviland, Elizabeth Hill, Georgina Manning, Morgaine Stiles, Emma Hall, Rebecca Lewis
mPFC-rTMS for patients with insomnia disorder using resting-state functional magnetic resonance imaging: a protocol for a randomized controlled trial
Jingjing Sun, Guohai Li, Danwei Zhang, Kaimo Ding, Jun Zhu, Si Luo, Wenyue Xu, Zhoubing Wang
Evaluation of a web-based randomized controlled trial educational intervention based on media literacy on preventing substance abuse among college students, applying the integrated social marketing approach: a study protocol
Hanieh Jormand, Saeed Bashirian, Majid Barati, Forouzan Rezapur-Shahkolai, Mohammad Babamiri
CARE 1000: randomized controlled trial for the evaluation of the effectiveness of a mHealth app for supporting the first 1000 days of life
Laura Brunelli, Sofia Bussolaro, Margherita Dal Cin, Luca Ronfani, Sara Zanchiello, Andrea Cassone, Giuseppa Verardi, Raffaella Dobrina, Michele Bava, Tamara Stampalija
The effect of postoperative early lumbar drainage on delayed fever after cerebellopontine angle tumour surgery: study protocol for a randomized controlled trial
Yunze Zhang, Yingxi Wu, Yang Wu, Gang Zhu, Yafei Xue, Yan Qu, Tianzhi Zhao
Effects of Internet of Things-based power cycling and neuromuscular training on pain and walking ability in elderly patients with KOA: protocol for a randomized controlled trial
Yujia Zhang, Suhang Xie, Xiaoyi Wang, Kangping Song, Lin Wang, Ruishi Zhang, Yuan Feng, Chengqi He
BORN study: a multicenter randomized trial investigating cord blood red blood cell transfusions to reduce the severity of retinopathy of prematurity in extremely low gestational age neonates
Luciana Teofili, Patrizia Papacci, Nicoletta Orlando, Maria Bianchi, Tina Pasciuto, Iolanda Mozzetta, Fernando Palluzzi, Luciano Giacò, Carmen Giannantonio, Giulia Remaschi, Michela Santosuosso, Enrico Beccastrini, Marco Fabbri, Caterina Giovanna Valentini, Tiziana Bonfini, Eleonora Cloclite, Patrizia Accorsi, Antonella Dragonetti, Francesco Cresi, Giulia Ansaldi, Genny Raffaeli, Stefania Villa, Giulia Pucci, Isabella Mondello, Michele Santodirocco, Stefano Ghirardello, Giovanni Vento
Safety, effectiveness, and adherence of a short and all-oral treatment regimen for the treatment of rifampicin-resistant tuberculosis in Niger: a study protocol of a pragmatic randomised clinical trial with stratified block randomisation
Mahamadou Bassirou Souleymane, Tom Decroo, Alphazazi Soumana, Ibrahim Maman Lawan, Assiatou Gagara-Issoufou, Souleymane Halidou-Moussa, Nimer Ortuño-Gutiérrez, Eric Adehossi, Saïdou Mamadou, Armand Van Deun, Alberto Piubello
Assessing the efficacy and safety of mycophenolate mofetil versus azathioprine in patients with autoimmune hepatitis (CAMARO trial): study protocol for a randomised controlled trial
Romée J. A. L. M. Snijders, Anna E. C. Stoelinga, Tom J. G. Gevers, Simon Pape, Maaike Biewenga, Robert C. Verdonk, Hendrik J. M. de Jonge, Jan Maarten Vrolijk, Sjoerd F. Bakker, Thomas Vanwolleghem, Ynto S. de Boer, Martine A. M. C. Baven Pronk, Ulrich H. W. Beuers, Adriaan J. van der Meer, Nicole M. F. van Gerven, Marijn G. M. Sijtsma, Bart J. Verwer, Ingrid A. M. Gisbertz, Maartje Bartelink, Floris F. van den Brand, Kerem Sebib Korkmaz, Aad P. van den Berg, Maureen M. J. Guichelaar, Khalida Soufidi, Amar D. Levens, Bart van Hoek, Joost P. H. Drenth
Effect of positive event recording based on positive psychology on healthy behaviors and readmission rate of patients after PCI: a study protocol for a prospective, randomized controlled trial
Yao-Yao Hu, Xin Jiang, Fang-Ying Mao, Jing Zhang, Lin Liu, Jie Gu, Qing Wu, Chun Li
ASCOT ADAPT study of COVID-19 therapeutics in hospitalised patients: an international multicentre adaptive platform trial
Justin T. Denholm, Balasubramanian Venkatesh, Joshua Davis, Asha C. Bowen, Naomi E. Hammond, Vivekanand Jha, Grace McPhee, Zoe McQuilten, Matthew V. N. O’Sullivan, David Paterson, David Price, Megan Rees, Jason Roberts, Mark Jones, James Totterdell, Thomas Snelling, Nanette Trask, Susan Morpeth, Steven YC Tong
The effect of Mediterranean diet on nutritional status, muscle mass and strength, and inflammatory factors in patients with colorectal cancer-induced cachexia: study protocol for a randomized clinical trial
Amir Bagheri, Mohammad Babaei, Saied Rezaei, Zoya Asl Motallebnejad, Maryam Ganjalikhani, Mahsa Malekahmadi, Ahmad Esmaillzadeh
Intravenous acetaminophen with morphine versus intravenous morphine alone for acute pain in the emergency room: protocol for a multicenter, randomized, placebo-controlled, double-blinded study (ADAMOPA)
Guillaume Cattin, Joel Jenvrin, Jean Benoit Hardouin, Céline Longo, Emmanuel Montassier
Footwear and insole design parameters to prevent occurrence and recurrence of neuropathic plantar forefoot ulcers in patients with diabetes: a series of N-of-1 trial study protocol
Sayed Ahmed, Paul Butterworth, Alex Barwick, Anita Sharma, Md Zobaer Hasan, Susan Nancarrow
A savings intervention to reduce men’s engagement in HIV risk behaviors: study protocol for a randomized controlled trial
Teniola I. Egbe, Ouma Dan Omollo, Julius Oduor Wesonga, Elizabeth F. Bair, Averi Chakrabarti, Mary E. Putt, Connie L. Celum, Carol S. Camlin, Sue Napierala, Kawango Agot, Harsha Thirumurthy
Oral vitamin D supplemental therapy to attain a desired serum 25-hydroxyvitamin D concentration in essential healthcare teams
Banafshe Hosseini, Cécile L. Tremblay, Cristina Longo, Shirin Glochi, John H. White, Caroline Quach, Louis-Georges Ste-Marie, Robert W. Platt, Francine M. Ducharme
How do we know a treatment is good enough? A survey of non-inferiority trials
Naomi Attard, Nikki Totton, Katie Gillies, Beatriz Goulao
Impact of a disability-targeted livelihoods programme in Bangladesh: study protocol for a cluster randomised controlled trial of STAR+
Lena Morgon Banks, Narayan Das, Calum Davey, Afsana Adiba, M. Mahzuz Ali, Tom Shakespeare, Coral Fleming, Hannah Kuper
Assessing the efficacy of male Wolbachia-infected mosquito deployments to reduce dengue incidence in Singapore: study protocol for a cluster-randomized controlled trial
Janet Ong, Soon Hoe Ho, Stacy Xin Hui Soh, Yvonne Wong, Youming Ng, Kathryn Vasquez, Yee Ling Lai, Yin Xiang Setoh, Chee-Seng Chong, Vernon Lee, Judith Chui Ching Wong, Cheong Huat Tan, Shuzhen Sim, Lee Ching Ng, Jue Tao Lim
Prolonging the time of progesterone supplementation to improve the pregnancy outcomes of single day 6 blastocyst transfer in frozen-thawed cycles: study protocol for a randomized controlled trial
Manlin Xu, Yuan Yan, Xiaoyue Shen, Haixiang Sun, Guijun Yan, Na Kong, Yue Jiang
Sanfu herbal patch applied at acupoints in patients with bronchial asthma: statistical analysis plan for a randomised controlled trial
Danghan Xu, Jialing Li, Anqi Di, Peidan Yang, Xiaoyan Xie, Yiming Xu, Jun He
Protocol for a randomised controlled trial to investigate the effects of vitamin K2 on recovery from muscle-damaging resistance exercise in young and older adults—the TAKEOVER study
Hannah Lithgow, Lynsey Johnston, Frederick K. Ho, Carlos Celis-Morales, James Cobley, Truls Raastad, Angus M. Hunter, Jennifer S. Lees, Patrick B. Mark, Terry J. Quinn, Stuart R. Gray
PrImary decompressive Craniectomy in AneurySmal Subarachnoid hemOrrhage (PICASSO) trial: study protocol for a randomized controlled trial
Erdem Güresir, Tim Lampmann, Simon Brandecker, Marcus Czabanka, Rolf Fimmers, Jens Gempt, Patrick Haas, Amer Haj, Ramazan Jabbarli, Darius Kalasauskas, Ralph König, Dorothee Mielke, Robert Németh, Marvin Darkwah Oppong, Andrej Pala, Vincent Prinz, Florian Ringel, Constantin Roder, Veit Rohde, Karl-Michael Schebesch, Arthur Wagner, Christoph Coch, Hartmut Vatter
Introducing insect- or plant-based dinner meals to families in Denmark: study protocol for a randomized intervention trial
Cassandra Maya, Luís Miguel Cunha, Ana Isabel de Almeida Costa, Teun Veldkamp, Nanna Roos
Peritoneal antiseptic irrigation to prevent surgical site infection after laparotomy for hepatobiliary or gastrointestinal surgery (PAISI)—protocol for a randomized controlled study
Tara Mueller, Victoria Kehl, Silvia Egert-Schwender, Helmut Friess, Alexander Novotny, Daniel Reim
Job retention vocational rehabilitation for employed people with inflammatory arthritis: adaptations to the WORKWELL trial due to the impact of the COVID-19 pandemic
Angela Ching, Jennifer Parker, Alexandra Haig, Chris J. Sutton, Sarah Cotterill, Denise Forshaw, June Culley, Alison Hammond
The comparison between the effects of pain education interventions with online and face-to-face exercise and the control group received biomedical education + standardized physical therapy in patients with chronic nonspecific neck pain during COVID-19: protocol for a parallel-group randomized controlled trial
Zohre Khosrokiani, Amir Letafatkar, Malihe Hadadnezhad, Yahya Sokhanguei
The Knee-Fix study: study protocol for a randomised controlled trial evaluating cemented and cementless components in total knee arthroplasty
Mei Lin Tay, Nina Zeng, Sherina Holland, Ali Bayan, Bill J. Farrington, Rupert van Rooyen, Rob Sharp, Robert S. J. Elliott, Matthew L. Walker, Simon W. Young
Ocular Rosacea microBiome Study (ORBS)—sub-microbial versus antibiotic dosing of doxycycline versus placebo in treatment of symptomatic ocular rosacea: study protocol for a parallel-arm randomized clinical trial
Hamidah Mahmud, Jeremy D. Keenan, John Gonzales, Julie Schallhorn, Matilda Chan, Benjamin Arnold, Victoria Cavallino, Thomas M. Lietman, Thuy Doan, Gerami D. Seitzman
A comprehensive transfer program from pediatrics to adult care for parents of adolescents with chronic illness (ParTNerSTEPs): study protocol for a randomized controlled trial
Ena Lindhart Thomsen, Kirsten Arntz Boisen, Signe Hanghøj, Helena Hansson, Heidi-Christina V. Grabow Scheelhardt, Susanne Thing Christensen, Bente Appel Esbensen
Evaluating the impact of Community-Based Sociotherapy on social dignity in post-genocide Rwanda: study protocol for a cluster randomized controlled trial
Stefan Jansen, Japhet Niyonsenga, Chantal Marie Ingabire, Angela Jansen, Emmanuel Nzabonimpa, Noella Ingabire, Jeannette Kangabe, Emmanuel Sarabwe, Annemiek Richters, Theoneste Rutayisire, Epaphrodite Nsabimana
Patient-reported outcomes in terms of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced oropharyngeal cancer patients treated with definitive chemo-radiotherapy: Swall PEG study
Tatiana Dragan, André Van Gossum, Frederic Duprez, Yassine Lalami, Yolene Lefebvre, Sofiana Mootassim-Billah, Sylvie Beauvois, Akos Gulyban, Christophe Vandekerkhove, Petra Boegner, Marianne Paesmans, Lieveke Ameye, Antoine Digonnet, Marie Quiriny, Didier Dequanter, Samuel Lipski, Esther Willemse, Alejandra Rodriguez, Sebastien Carlot, Yasemin Karaca, Marc Lemort, Patrick Emonts, Clémence Al Wardi, Dirk Van Gestel
Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new insights
Josep Ramon Marsal, Iratxe Urreta-Barallobre, Marimar Ubeda-Carrillo, Dimelza Osorio, Blanca Lumbreras, David Lora, Borja M. Fernández-Felix, Gerard Oristrell, Eduard Ródenas-Alesina, Lorena Herrador, Mónica Ballesteros, Javier Zamora, Jose I. Pijoan, Aida Ribera, Ignacio Ferreira-González
Underrepresentation of women in randomized controlled trials: a systematic review and meta-analysis
Vered Daitch, Adi Turjeman, Itamar Poran, Noam Tau, Irit Ayalon-Dangur, Jeries Nashashibi, Dafna Yahav, Mical Paul, Leonard Leibovici
Establishing a Core Domain Set for early-phase clinical trials of electrical stimulation interventions for tinnitus in adults: protocol for an online Delphi study
Bas Labree, Derek J. Hoare, Kathryn Fackrell, Deborah A. Hall, Lauren E. Gascoyne, Magdalena Sereda
The DEVA trial: protocol for a randomised controlled trial of dequalinium chloride versus usual care antibiotics for the treatment of bacterial vaginosis
Rebecca Haydock, Trish Hepburn, Jonathan Ross, Jane Daniels, Clare Brittain, Louise Jackson, Mara Ozolins, Janet Wilson
The effect of a phytoestrogen intervention and impact of genetic factors on tumor proliferation markers among Swedish patients with prostate cancer: study protocol for the randomized controlled PRODICA trial
Rebecca Ahlin, Sanna Nybacka, Andreas Josefsson, Johan Stranne, Gunnar Steineck, Maria Hedelin
Clazakizumab for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients: Phase 3 IMAGINE study rationale and design
Peter W. Nickerson, Georg A. Böhmig, Steve Chadban, Deepali Kumar, Roslyn B. Mannon, Teun van Gelder, James C. Lee, Scott Adler, Edward Chong, Arjang Djamali
Reducing HIV-related stigma among young people attending school in Northern Uganda: study protocol for a participatory arts-based population health intervention and stepped-wedge cluster-randomized trial
Joshua B. Mendelsohn, Bonnie Fournier, Stéphanie Caron-Roy, Geoffrey Maina, Gillian Strudwick, Santo Ojok, Hyun June Lim, Marcos Sanches, Carmen H. Logie, Susan Sommerfeldt, Candace Nykiforuk, Jean Harrowing, Francis Akena Adyanga, Jussy Okello Hakiigaba, Olenka Bilash
A novel trial methodology to test interventions with very large effect sizes: the case of dostarlimab in mismatch repair-deficient, locally advanced rectal cancer
Kerrington Powell, Timothée Olivier, Vinay Prasad
StudyMe: a new mobile app for user-centric N-of-1 trials
Alexander M. Zenner, Erwin Böttinger, Stefan Konigorski
Effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with lumbar spinal stenosis with neurogenic claudication: a randomized controlled clinical trial protocol
Mariève Houle, Charles Tétreau, Claude-Édouard Châtillon, Andrée-Anne Marchand, Martin Descarreaux
A good use of time? Providing evidence for how effort is invested in primary and secondary outcome data collection in trials
Heidi Gardner, Adel Elfeky, David Pickles, Annabel Dawson, Katie Gillies, Violet Warwick, Shaun Treweek
Evaluation of accuracy of photogrammetry with 3D scanning and conventional impression method for craniomaxillofacial defects using a software analysis
Arushi Beri, Sweta Kale Pisulkar, Ashutosh D. Bagde, Akansha Bansod, Chinmayee Dahihandekar, Balaji Paikrao
Efficacy of hearing aid treatment on sound perception and residual hearing preservation in patients with tinnitus and coexisting hearing loss: study protocol for a randomized controlled trial
Peifan Li, Dongmei Tang, Yongzhen Wu, Yanbo Yin, Shan Sun
Promoting psychological well-being in preschool children: study protocol for a randomized controlled trial of a mindfulness- and yoga-based socio-emotional learning intervention
O. Courbet, Q. Daviot, V. Kalamarides, M. Habib, M-C C Castillo, T. Villemonteix
Measuring the impact of a “Virtual Pediatric Trauma Center” (VPTC) model of care using telemedicine for acutely injured children versus the standard of care: study protocol for a prospective stepped-wedge trial
James P. Marcin, Daniel J. Tancredi, Joseph M. Galante, Tanya N. Rinderknecht, Brian M. Haus, Holly B. Leshikar, Marike Zwienenberg, Jennifer L. Rosenthal, Kendra L. Grether-Jones, Michelle Y. Hamline, Jeffrey S. Hoch, Nathan Kuppermann
A mental health-informed, online health promotion programme targeting physical activity and healthy eating for adults aged 60+ years: study protocol for the MovingTogether randomised controlled trial
Chiara Mastrogiovanni, Simon Rosenbaum, Kim Delbaere, Anne Tiedemann, Scott Teasdale, Annaliese McGavin, Nancy Briggs, Grace McKeon
Comparison between two methods of the immediate post-placental insertion of copper intrauterine device in vaginal birth—a protocol for a randomized clinical trial
Thuany Bento Herculano, Fernanda Garanhani Surita, Cássia Raquel Teatin Juliato, Patrícia Moretti Rehder
Minimising Young Children’s Anxiety through Schools (MY-CATS): statistical analysis plan for a cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of an online parent-led intervention compared with usual school practice for young children identified as at risk for anxiety disorders
Benjamin G. Jones, Tessa Reardon, Cathy Creswell, Helen F. Dodd, Claire Hill, Bec Jasper, Peter J. Lawrence, Fran Morgan, Ronald M. Rapee, Mara Violato, Anna Placzek, Obioha C. Ukoumunne
Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial
Tanya J. Symons, Nicola Straiton, Rosie Gagnon, Roberta Littleford, Anita J. Campbell, Asha C. Bowen, Adam G. Stewart, Steven Y. C. Tong, Joshua S. Davis
Application of Pender’s health promotion model for type 2 diabetes treatment adherence: protocol for a mixed methods study in southern Iran
Nahid Shahabi, Zahra Hosseini, Teamur Aghamolaei, Amin Ghanbarnejad, Ahmad Behzad
Safety and microbiological activity of phage therapy in persons with cystic fibrosis colonized with Pseudomonas aeruginosa: study protocol for a phase 1b/2, multicenter, randomized, double-blind, placebo-controlled trial
Pranita D. Tamma, Maria Souli, Michael Billard, Joseph Campbell, Douglas Conrad, Damon W. Ellison, Beth Evans, Scott R. Evans, Kerryl E. Greenwood-Quaintance, Andrey A. Filippov, Holly S. Geres, Toshimitsu Hamasaki, Lauren Komarow, Mikeljon P. Nikolich, Thomas P. Lodise, Seema U. Nayak, Carmelle Norice-Tra, Robin Patel, David Pride, Janie Russell, Daria Van Tyne, Henry F. Chambers, Vance G. FowlerJr, Robert T. Schooley
Pneumococcal vaccine schedules (PVS) study: a cluster-randomised, non-inferiority trial of an alternative versus standard schedule for pneumococcal conjugate vaccination—statistical analysis plan
Grant A. Mackenzie, Arto A. Palmu, Jukka Jokinen, Isaac Osei, Stefan Flasche, Brian Greenwood, Kim Mulholland, Cattram Nguyen
The effect of virtual specialist conferences between endocrinologists and general practitioners about type 2 diabetes: study protocol for a pragmatic randomized superiority trial
Thim Prætorius, Anne Sofie Baymler Lundberg, Esben Søndergaard, Søren Tang Knudsen, Annelli Sandbæk
High-flow nasal cannula therapy with sequential noninvasive ventilation versus noninvasive ventilation alone as the initial ventilatory strategy in acute COPD exacerbations: study protocol for a randomized controlled trial
Shuai Liu, Joseph Harold Walline, Huadong Zhu, Yan Li, Chunting Wang, Jihai Liu
Focused Ultrasound and RadioTHERapy for non-invasive palliative pain treatment in patients with bone metastasis: a study protocol for the three armed randomized controlled FURTHER trial
Derk J. Slotman, Marcia M. T. J. Bartels, Cyril J. Ferrer, Clemens Bos, Lambertus W. Bartels, Martijn F. Boomsma, Erik C. J. Phernambucq, Ingrid M. Nijholt, Alessio G. Morganti, Giambattista Siepe, Milly Buwenge, Holger Grüll, Grischa Bratke, Sin Yuin Yeo, Roberto Blanco Sequeiros, Heikki Minn, Mira Huhtala, Alessandro Napoli, Francesca De Felice, Carlo Catalano, Alberto Bazzocchi, Chiara Gasperini, Laura Campanacci, Julia Simões Corrêa Galendi, Dirk Müller, Manon N. G. J. A. Braat, Chrit Moonen, Helena M. Verkooijen
Study protocol for ACTIVE study: safety and feasibility evaluation of external ventricular drainage with ACTIVE fluid exchange in intraventricular hemorrhage—a phase 2, multi-center, randomized controlled trial
Mette Haldrup, Niwar Mohamad, Mads Rasmussen, Line Thorup, Stig Dyrskog, Claus Ziegler Simonsen, Rares Miscov, Carsten Reidies Bjarkam, Mads Grønhøj, Frantz Rom Poulsen, Anders Rosendal Korshøj
A protocol for a randomized clinical trial assessing the efficacy of hypertonic dextrose injection (prolotherapy) in chronic ankle instability
Regina Wing Shan Sit, Ricky Wing Keung Wu, Samuel Ka Kin Ling, Bo Wang, Dicken Cheong Chun Chan, Benjamin Hon Kei Yip, Samuel Yeung Shan Wong, Kenneth Dean Reeves, David Rabago
Transcutaneous electrical acupoint stimulation to reduce opioid consumption in patients undergoing inguinal hernia repair: protocol for a randomized controlled trial
Siddarth Agrawal, Mateusz Szmit, Marek Wełna, Jerzy Rudnicki, Anil Agrawal, Waldemar Goździk
Conservative versus surgical treatment of foot drop in peroneal nerve entrapment: rationale and design of a prospective, multi-centre, randomized parallel-group controlled trial
Christophe Oosterbos, Sofie Rummens, Kris Bogaerts, Sophie Hoornaert, Frank Weyns, Annie Dubuisson, Robin Lemmens, Tom Theys
Effects of osteopathic manipulative treatment associated with pain education and clinical hypnosis in individuals with chronic low back pain: study protocol for a randomized sham-controlled clinical trial
Guilherme Luis Santana Luchesi, Anne Kastelianne França da Silva, Otávio Henrique Borges Amaral, Vanessa Cristina Godoi de Paula, Fabrício José Jassi
Effects of pre-operative oral carbohydrates on insulin resistance and postoperative recovery in diabetic patients undergoing coronary artery bypass grafting: study protocol for a prospective, single-blind, randomized controlled trial
Shicheng Zhang, Lixian He, Yiping Yu, Xin Yuan, Tao Yang, Fuxia Yan, Fei Xu, Yan Zhang, Shiwei Pan, Huaijun Zhang, Zujun Chen, Lu Xie, Rong Wu, Wei Feng, Yuntai Yao