Trials

Recombinant human C1 esterase inhibitor (conestat alfa) in the prevention of severe SARS-CoV-2 infection in hospitalized patients with COVID-19: A structured summary of a study protocol for a randomized, parallel-group, open-label, multi-center pilot trial (PROTECT-COVID-19)

Pascal Urwyler, Panteleimon Charitos, Stephan Moser, Ingmar A. F. M. Heijnen, Marten Trendelenburg, Reto Thoma, Johannes Sumer, Adrián Camacho-Ortiz, Marcelo R. Bacci, Lars C. Huber, Melina Stüssi-Helbling, Werner C. Albrich, Parham Sendi, Michael Osthoff

Virucidal effect of povidone iodine on COVID-19 in the nasopharynx: A structured summary of a study protocol for an open-label randomized clinical trial

Mohammad Jahid Hasan, S. K. Nurul Fattah Rumi, Sultana Sahana Banu, A. K. M. Nasir Uddin, Md Shahnoor Islam, Mostafa Kamal Arefin

Efficacy and safety of nitazoxanide plus atazanavir/ritonavir for the treatment of moderate to severe COVID-19 (NACOVID): A structured summary of a study protocol for a randomised controlled trial

Adeniyi Olagunju, Adeola Fowotade, Ajibola Olagunoye, Temitope Olumuyiwa Ojo, Bolanle Olufunlola Adefuye, Adeniyi Francis Fagbamigbe, Akindele Olupelumi Adebiyi, Omobolanle Ibitayo Olagunju, Olabode Taiwo Ladipo, Abdulafeez Akinloye, Babatunde Ayodeji Adeagbo, Adedeji Onayade, Oluseye Oladotun Bolaji, Christian Happi, Steve Rannard, Andrew Owen

The efficacy and safety of Ivermectin in patients with mild and moderate COVID-19: A structured summary of a study protocol for a randomized controlled trial

Fatemeh Sadat Hosseini, Alireza Malektojari, Sara Ghazizadeh, Mehdi Hassaniazad, Parivash Davoodian, Habib Dadvand, Amin Reza Nikpoor, Sara Nikoofal-Sahlabadi, Sara Kahoori, Mojtaba Sepandi, Soheil Hassanipour, Mohammad Fathalipour

A randomised controlled trial comparing palate surgery at 6 months versus 12 months of age (the TOPS trial): a statistical analysis plan

Elizabeth J. Conroy, Rachael Cooper, William Shaw, Christina Persson, Elisabeth Willadsen, Kevin J. Munro, Paula R. Williamson, Gunvor Semb, Tanya Walsh, Carrol Gamble

Combined low-dose everolimus and low-dose tacrolimus after Alemtuzumab induction therapy: a randomized prospective trial in lung transplantation

Alberto Benazzo, Ara Cho, Anna Nechay, Stefan Schwarz, Florian Frommlet, Thomas Wekerle, Konrad Hoetzenecker, Peter Jaksch

Statistical analysis plan for the Prophylactic Melatonin for Delirium in Intensive Care (ProMEDIC): a randomised controlled trial

Bradley Wibrow, F. Eduardo Martinez, Andrew Ford, Erin Kelty, Kevin Murray, Kwok M. Ho, Edward Litton, Erina Myers, Matthew Anstey

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial

Gordon McGregor, Harbinder Sandhu, Julie Bruce, Bartholomew Sheehan, David McWilliams, Joyce Yeung, Christina Jones, Beatriz Lara, Jessica Smith, Chen Ji, Elaine Fairbrother, Stuart Ennis, Peter Heine, Sharisse Alleyne, Jonathan Guck, Emma Padfield, Rachel Potter, James Mason, Ranjit Lall, Kate Seers, Martin Underwood

Double-blind, randomized, controlled, trial to assess the efficacy of allogenic mesenchymal stromal cells in patients with acute respiratory distress syndrome due to COVID-19 (COVID-AT): A structured summary of a study protocol for a randomised controlled trial

Concepción Payares-Herrera, María E. Martínez-Muñoz, Inés Lipperheide Vallhonrat, Rosa Malo de Molina, Manuel Pérez Torres, Andrea Trisan, Isabel Salcedo de Diego, Rosalía Alonso, Rocío Zafra, Trinidad Donaire, Rocío Sánchez, Juan José Rubio, Rafael F. Duarte Palomino, Cristina Avendaño Solá

Safety and clinical efficacy of the secretome of stressed peripheral blood mononuclear cells in patients with diabetic foot ulcer—study protocol of the randomized, placebo-controlled, double-blind, multicenter, international phase II clinical trial MARSYAS II

Alfred Gugerell, Ghazaleh Gouya-Lechner, Helmut Hofbauer, Maria Laggner, Franz Trautinger, Gabriele Almer, Anja Peterbauer-Scherb, Marcus Seibold, Wolfram Hoetzenecker, Christiane Dreschl, Michael Mildner, Hendrik Jan Ankersmit

Reporting guidelines for clinical trials of artificial intelligence interventions: the SPIRIT-AI and CONSORT-AI guidelines

Hussein Ibrahim, Xiaoxuan Liu, Samantha Cruz Rivera, David Moher, An-Wen Chan, Matthew R. Sydes, Melanie J. Calvert, Alastair K. Denniston

Partnering with general practitioners to optimize survivorship for patients with lymphoma: a phase II randomized controlled trial (the GOSPEL I trial)

Raymond Javan Chan, Stephanie Buhagiar, Laisa Teleni, Camilla Simonsen, Jane Turner, Courtney Rawson, Nicolas H. Hart, Lee Jones, Louisa Gordon, Ria Joseph, Oluwaseyifunmi Andi Agbejule, Fiona Henderson, Joel Rhee, Marissa Ryan, Christine Carrington, Sally Mapp

Adapting the randomised controlled trial (RCT) for precision medicine: introducing the nested-precision RCT (npRCT)

Nils Kappelmann, Bertram Müller-Myhsok, Johannes Kopf-Beck

Efficacy of simultaneous aerobic exercise and cognitive training in subjective cognitive decline: study protocol for randomized controlled trial of the Exergames Study

Dereck Salisbury, Tom Plocher, Fang Yu

The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled non-inferiority multicenter trial (Ketodex): a statistical analysis plan

Anna Heath, Juan David Rios, Eleanor Pullenayegum, Petros Pechlivanoglou, Martin Offringa, Maryna Yaskina, Rick Watts, Shana Rimmer, Terry P. Klassen, Kamary Coriolano, Naveen Poonai, Darcy Beer, Scott Sawyer, Maala Bhatt, April Kam, Quynh Doan, Vikram Sabhaney, Serena Hickes, Samina Ali, Karly Stillwell, Tannis Erickson, Chelsea Bowkett, Carolyn Shimmin, Brendon Foot, Chelsea Bowkett, Candace McGahern, Redjana Carciurmaruj, Jeannine Schellenberg

Effect of different rehabilitation training timelines to prevent shoulder dysfunction among postoperative breast cancer patients: study protocol for a randomized controlled trial

Yu-Wei Shao, Qing Shu, Dan Xu, Hui Teng, Gao-Song Wu, Jin-Xuan Hou, Jun Tian

Testing strategies for couple engagement in prevention of mother-to-child transmission of HIV and family health in Kenya: study protocol for a randomized controlled trial

Zachary Kwena, Liza Kimbo, Lynae A. Darbes, Abigail M. Hatcher, Anna Helova, George Owino, Harsha Thirumurthy, Elizabeth A. Bukusi, Thomas Braun, Meredith Kilgore, Maria Pisu, Ashutosh Tamhane, Van T. Nghiem, Kawango Agot, Torsten B. Neilands, Janet M. Turan

A comparison of approaches for combining predictive markers for personalised treatment recommendations

Matthias Pierce, Richard Emsley

Acupuncture for chronic persistent asthma based on the theory of Meridian-viscera Association: study protocol for a multi-center randomized controlled trial in China

Shirui Cheng, Xiaohui Dong, Lei Lan, Zhaoxuan He, Siyi Yu, Yi Yang, Chuantao Zhang, Mei Chen, Jun Yang, Haoran Chu, Yalan Liu, Menglin Wang, Qingsong Huang, Fang Zeng

Protocol for the methamphetamine approach-avoidance training (MAAT) trial, a randomised controlled trial of personalised approach bias modification for methamphetamine use disorder

Joshua B. B. Garfield, Hugh Piercy, Shalini Arunogiri, Dan I. Lubman, Samuel C. Campbell, Paul G. Sanfilippo, Jeff Gavin, Malcolm Hopwood, Eli Kotler, Suzanne George, Goke Okedara, Lara R. Piccoli, Victoria Manning

Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial

Stacey Haukeland-Parker, Øyvind Jervan, Hege Hølmo Johannessen, Jostein Gleditsch, Knut Stavem, Kjetil Steine, Martijn A. Spruit, René Holst, Mazdak Tavoly, Frederikus A. Klok, Waleed Ghanima

A structured summary of a study protocol for a multi-center, randomized controlled trial (RCT) of COVID-19 prevention with Kampo medicines (Integrative Management in Japan for Epidemic Disease by prophylactic study: IMJEDI P1 study)

Takao Namiki, Shin Takayama, Ryutaro Arita, Tadashi Ishii, Mosaburo Kainuma, Toshiaki Makino, Masaru Mimura, Tetsuhiro Yoshino, Tatsuya Nogami, Makoto Arai, Juichi Sato, Koichiro Tanaka, Hajime Nakae, Hidetoshi Igari, Yoshihito Ozawa, Yuki Shiko, Yohei Kawasaki, Masahiko Nezu, Takashi Ito

Exercise therapy and patient education versus intra-articular saline injections in the treatment of knee osteoarthritis: an evidence-based protocol for an open-label randomised controlled trial (the DISCO trial)

Elisabeth Bandak, Anders F. Overgaard, Lars Erik Kristensen, Karen Ellegaard, Jørgen Guldberg-Møller, Cecilie Bartholdy, David J. Hunter, Roy D. Altman, Robin Christensen, Henning Bliddal, Marius Henriksen

Efficacy of repetitive transcranial magnetic stimulation combined with visual scanning treatment on cognitive and behavioral symptoms of left hemispatial neglect in right hemispheric stroke patients: study protocol for a randomized controlled trial

Francesco Di Gregorio, Fabio La Porta, Emanuela Casanova, Elisabetta Magni, Roberta Bonora, Maria Grazia Ercolino, Valeria Petrone, Maria Rosaria Leo, Roberto Piperno

Effect of sevoflurane on the inflammatory response during cardiopulmonary bypass in cardiac surgery: the study protocol for a randomized controlled trial

Thiago Augusto Azevedo Maranhão Cardoso, Gudrun Kunst, Caetano Nigro Neto, José de Ribamar Costa Júnior, Carlos Gustavo Santos Silva, Gisele Medeiros Bastos, Jéssica Bassani Borges, Mario Hiroyuki Hirata

An exercise trial for adults undergoing neoadjuvant chemoradiotherapy for rectal cancer proves not feasible: recommendations for future trials

Jennifer Brunet, Jenson Price, Céline Delluc

Effects of different acupuncture treatment methods on post-stroke cognitive impairment: study protocol for a multicenter randomized controlled trial

Kai-Qi Su, Su-Tong Liu, Jie-Ying Li, Rui-Qing Li, Hui-Li Feng, Yang Xue, Xiao-Dong Feng

ICan, an Internet-based intervention to reduce cannabis use: study protocol for a randomized controlled trial

Marleen I. A. Olthof, Matthijs Blankers, Margriet W. van Laar, Anna E. Goudriaan

A fixed nitrous oxide/oxygen mixture as an analgesic for patients with postherpetic neuralgia: study protocol for a randomized controlled trial

Hai-Xiang Gao, Jun-Jun Zhang, Ning Liu, Yi Wang, Chun-Xiang Ma, Lu-Lu Gao, Qiang Liu, Ting-Ting Zhang, Yi-Ling Wang, Wen-Qiang Bao, Yu-Xiang Li

Efficacy of prophylactic methylprednisolone on reducing the risk of post-extubation stridor in patients after an emergency intubation: study protocol for a randomized controlled trial

Jingyi Wang, Joseph Harold Walline, Lu Yin, Yili Dai, Jiayuan Dai, Huadong Zhu, Xuezhong Yu, Jun Xu

Identifying student opinion leaders to lead e-cigarette interventions: protocol for a randomized controlled pragmatic trial

Kar-Hai Chu, Sara Matheny, Alexa Furek, Jaime Sidani, Susan Radio, Elizabeth Miller, Thomas Valente, Linda Robertson

Improving gait adaptability in patients with hereditary spastic paraplegia (Move-HSP): study protocol for a randomized controlled trial

Lotte van de Venis, Bart P. C. van de Warrenburg, Vivian Weerdesteyn, Bas J. H. van Lith, Alexander C. H. Geurts, Jorik Nonnekes

Continuous warfarin administration versus heparin bridging therapy in post colorectal polypectomy haemorrhage: a study protocol for a multicentre randomised controlled trial (WHICH study)

Yasuaki Nagami, Taishi Sakai, Masafumi Yamamura, Masami Nakatani, Takayuki Katsuno, Takehisa Suekane, Hironori Uno, Hiroaki Minamino, Masatsugu Okuyama, Junichi Okamoto, Mitsutaka Kumamoto, Atsushi Noguchi, Kazuki Yamamori, Osamu Takaishi, Masahiro Ochi, Takako Miyazaki, Shigetsugu Tsuji, Hisatomo Ikehara, Koichiro Kawaguchi, Tomoyuki Hayashi, Tomohiko Mannami, Kazuki Kakimoto, Yoshihide Naito, Satoru Hashimoto, Zhaoliang Li, Yoriaki Komeda, Takaaki Kishino, Yoshinobu Yamamoto, Mikitaka Iguchi, Takuji Akamatsu, Toshiki Horii, Ko Miura, Takeshi Yamashina, Yuusaku Sugihara, Noboru Watanabe, Shu Kiyotoki, Ryoji Fujii, Masaki Murata, Satoshi Ono, Toshiaki Narasaka, Shinji Kitamura, Mitsuhiro Kono, Motohiko Kato, Hideto Kawaratani, Kyosuke Tanaka, Takao Yaoita, Shinjiro Yamaguchi, Keiichiro Abe, Takuji Kawamura, Yosuke Kinoshita, Kenichiro Imai, Haruka Fujinami, Tomoyuki Yada, Hayato Miyamoto, Hisako Yoshida, Yasuhiro Fujiwara

Efficacy of acupuncture for sciatica: study protocol for a randomized controlled pilot trial

Fang-Ting Yu, Guang-Xia Ni, Guo-Wei Cai, Wen-Jun Wan, Xiao-Qing Zhou, Xiu-Li Meng, Jin-Ling Li, Jian-Feng Tu, Li-Qiong Wang, Jing-Wen Yang, Hai-Yang Fu, Xin-Chang Zhang, Jing Li, Yan-Fu Wang, Beng Zhang, Xiao-Hui Zhang, Hao-Lin Zhang, Guang-Xia Shi, Cun-Zhi Liu

Acupuncture for persistent atrial fibrillation after catheter ablation: study protocol for a pilot randomized controlled trial

Ying Lin, Xian Wang, Xue-Bin Li, Bang-Qi Wu, Zhao-Hui Zhang, Wei-Hua Guo, Cun-Cao Wu, Xin Chen, Ming-Long Chen, Zhong Dai, Fu-Yan Chen, Rui Zhu, Chu-Xi Liang, Yun-Peng Tian, Gang Yang, Chao-Qun Yan, Jing Lu, Hai-Ying Wang, Jin-Ling Li, Jian-Feng Tu, He-Wen Li, Dan-Dan Yang, Fang-Ting Yu, Yu Wang, Jing-Wen Yang, Guang-Xia Shi, Shi-Yan Yan, Li-Qiong Wang, Cun-Zhi Liu

Effects of intraoperative goal-directed fluid therapy and restrictive fluid therapy combined with enhanced recovery after surgery protocol on complications after thoracoscopic lobectomy in high-risk patients: study protocol for a prospective randomized controlled trial

Zheng Guan, Yanfeng Gao, Qiao Qiao, Qiang Wang, Jingjie Liu

Antiplatelet therapy for the prevention of atherosclerosis in chronic kidney disease (ALTAS-CKD) patients: study protocol for a randomized clinical trial

Jiachuan Xiong, Ting He, Zhikai Yu, Ke Yang, Feng Chen, Jingbo Cheng, Yu Shi, Yinghui Huang, Yu Qiao, Haiyang Li, Yunzhu Shen, Jinghong Zhao

A platform trial in practice: adding a new experimental research arm to the ongoing confirmatory FLAIR trial in chronic lymphocytic leukaemia

Dena R. Howard, Anna Hockaday, Julia M. Brown, Walter M. Gregory, Susan Todd, Tahla Munir, Jamie B. Oughton, Claire Dimbleby, Peter Hillmen

Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): a structured summary of a study protocol for a cluster-randomised, two-factorial controlled trial

Andreas Deckert, Simon Anders, Manuela de Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Kathleen Boerner, Matthias Meurer, Konrad Herbst, Matthias Sand, Lisa Koeppel, Tobias Siems, Lucia Brugnara, Stephan Brenner, Robin Burk, Dan Lou, Daniel Kirrmaier, Yuanqiang Duan, Svetlana Ovchinnikova, Michael Marx, Hans Georg Kräusslich, Michael Knop, Till Bärnighausen, Claudia Denkinger

Evaluation of robotic versus open partial pancreatoduodenectomy—study protocol for a randomised controlled pilot trial (EUROPA, DRKS00020407)

Rosa Klotz, Colette Dörr-Harim, Thomas Bruckner, Philipp Knebel, Markus K. Diener, Thilo Hackert, André L. Mihaljevic

Minimally Invasive Versus open AbdominoThoracic Esophagectomy for esophageal carcinoma (MIVATE) — study protocol for a randomized controlled trial DRKS00016773

Felix Nickel, Pascal Probst, Alexander Studier-Fischer, Henrik Nienhüser, Jana Pauly, Karl-Friedrich Kowalewski, Sebastian Weiterer, Philipp Knebel, Markus K. Diener, Markus A. Weigand, Markus W. Büchler, Thomas Schmidt, Beat P. Müller-Stich

Testing the efficacy and safety of BIO101, for the prevention of respiratory deterioration, in patients with COVID-19 pneumonia (COVA study): a structured summary of a study protocol for a randomised controlled trial

W. Dioh, M. Chabane, C. Tourette, A. Azbekyan, C. Morelot-Panzini, L. A. Hajjar, M. Lins, G. B. Nair, T. Whitehouse, J. Mariani, M. Latil, S. Camelo, R. Lafont, P. J. Dilda, S. Veillet, S. Agus

Treatment of COVID-19 pneumonia with glucocorticoids (CORTIVID): a structured summary of a study protocol for a randomised controlled trial

Iñigo Les Bujanda, Jose Loureiro-Amigo, Ferran Capdevila Bastons, Iñaki Elejalde Guerra, Javier Anniccherico Sánchez, Anna Murgadella-Sancho, Ruth García Rey, Julián Librero López, Julio Sánchez Álvarez

Hydroxychloroquine in the treatment of adult patients with Covid-19 infection in a primary care setting (LIBERTY): A structured summary of a study protocol for a randomised controlled trial

Petri J. Vainio, Pauliina Hietasalo, Anna-Liisa Koivisto, Susanna Kääriäinen, Jari Turunen, Mika Virtala, Jouni Vuorinen, Mika Scheinin

Efficacy of a joint didactic intervention using the Junta De Andalucía School for Patients method to control prothrombin time in patients taking anticoagulants: protocol for a randomized controlled trial

Leovigildo Ginel-Mendoza, Alfonso Hidalgo-Natera, Rocío Reina-Gonzalez, Rafael Poyato-Ramos, Juana Morales-Naranjo, Inmaculada Lupiañez-Pérez, Antonio Baca-Osorio, Miguel Gutiérrez-Jansen, María Paz Fernández-Lara, Diego Lozano-Noriega, Ulises Salgado-Carvallo, Cristina Bandera-García, Francisco Javier Navarro-Moya

Enhancing behavioral sleep care with digital technology: study protocol for a hybrid type 3 implementation-effectiveness randomized trial

Anne Germain, Rachel R. Markwald, Erika King, Adam D. Bramoweth, Megan Wolfson, Gilbert Seda, Tony Han, Erin Miggantz, Brian O’Reilly, Lars Hungerford, Traci Sitzer, Vincent Mysliwiec, Joseph J. Hout, Meredith L. Wallace

eRegCom—Quality Improvement Dashboard for healthcare providers and Targeted Client Communication to pregnant women using data from an electronic health registry to improve attendance and quality of antenatal care: study protocol for a multi-arm cluster randomized trial

Kjersti Mørkrid, Binyam Bogale, Eatimad Abbas, Khadija Abu Khader, Itimad Abu Ward, Amjad Attalh, Tamara Awwad, Mohammad Baniode, Kimberly Suzanne Frost, Michael James Frost, Buthaina Ghanem, Taghreed Hijaz, Mervett Isbeih, Sally Issawi, Zaher A. S. Nazzal, Brian O’Donnell, Sharif E. Qaddomi, Yousef Rabah, Mahima Venkateswaran, J. Frederik Frøen

Navigate: a study protocol for a randomised controlled trial of an online treatment decision aid for men with low-risk prostate cancer and their partners

Penelope Schofield, Karla Gough, Amelia Hyatt, Alan White, Mark Frydenberg, Suzanne Chambers, Louisa G. Gordon, Robert Gardiner, Declan G. Murphy, Lawrence Cavedon, Natalie Richards, Barbara Murphy, Stephen Quinn, Ilona Juraskova

Viral load-guided immunosuppression after lung transplantation (VIGILung)—study protocol for a randomized controlled trial

Jens Gottlieb, Alexander Reuss, Konstantin Mayer, Karin Weide, Carmen Schade-Brittinger, Susanne Hoyer, Peter Jaksch

Absolute vs. relative effects—implications for subgroup analyses

Lars W. Andersen

The impact of computer-based cognitive training intervention on the quality of life among elderly people: a randomized clinical trial

Leila kazazi, Mohsen Shati, Seyede Salehe Mortazavi, Vahid Nejati, Mahshid Foroughan

A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study

Mohammed Limbada, Chiti Bwalya, David Macleod, Sian Floyd, Ab Schaap, Vasty Situmbeko, Richard Hayes, Sarah Fidler, Helen Ayles

Using brain functional magnetic resonance imaging to evaluate the effectiveness of acupuncture combined with mirror therapy on upper limb function in patients with cerebral ischemic stroke: a study protocol for a randomized, controlled trial

Mingzhu Xu, Run Lin, Jing Luo, Chunzhi Tang, Shuhui Wang, John Wong, Meng Wu, Jianting Huang, Peng Shi, Ang Gao, Yuqian Bai, Ying Xie, Jun Luo, Yunqiu Yang, Shaoyang Cui

Maximising recruitment to a randomised controlled trial for chronic rhinosinusitis using qualitative research methods: the MACRO conversation study

Clare McDermott, Jane Vennik, Carl Philpott, Steffi le Conte, Mike Thomas, Caroline Eyles, Paul Little, Helen Blackshaw, Anne Schilder, Claire Hopkins

Chinese herbal extract granules combined with 5-aminosalicylic acid for patients with moderately active ulcerative colitis: study protocol for a multicenter randomized double-blind placebo-controlled trial

Zhaofeng Shen, Kai Zheng, Jiandong Zou, Peiqing Gu, Jing Xing, Lu Zhang, Lei Zhu, Hong Shen

The NYCKidSeq project: study protocol for a randomized controlled trial incorporating genomics into the clinical care of diverse New York City children

Jacqueline A. Odgis, Katie M. Gallagher, Sabrina A. Suckiel, Katherine E. Donohue, Michelle A. Ramos, Nicole R. Kelly, Gabrielle Bertier, Christina Blackburn, Kaitlyn Brown, Lena Fielding, Jessenia Lopez, Karla Lopez Aguiniga, Estefany Maria, Jessica E. Rodriguez, Monisha Sebastin, Nehama Teitelman, Dana Watnick, Nicole M. Yelton, Avinash Abhyankar, Noura S. Abul-Husn, Aaron Baum, Laurie J. Bauman, Jules C. Beal, Toby Bloom, Charlotte Cunningham-Rundles, George A. Diaz, Siobhan Dolan, Bart S. Ferket, Vaidehi Jobanputra, Patricia Kovatch, Thomas V. McDonald, Patricia E. McGoldrick, Rosamond Rhodes, Michael L. Rinke, Mimsie Robinson, Arye Rubinstein, Lisa H. Shulman, Christian Stolte, Steven M. Wolf, Elissa Yozawitz, Randi E. Zinberg, John M. Greally, Bruce D. Gelb, Carol R. Horowitz, Melissa P. Wasserstein, Eimear E. Kenny

The reality of informed consent: empirical studies on patient comprehension—systematic review

Tomasz Pietrzykowski, Katarzyna Smilowska

Physiotherapeutic scoliosis-specific exercises performed immediately after spinal manipulative therapy for the treatment of mild adolescent idiopathic scoliosis: study protocol for a randomized controlled pilot trial

Li Wang, Chun Wang, Ahmed S. A. Youssef, Jiang Xu, Xiaolin Huang, Nan Xia

Missing clinical trial data: the evidence gap in primary data for potential COVID-19 drugs

Florence Rodgers, Toby Pepperrell, Sarai Keestra, Victoria Pilkington

Evaluation of the efficacy and safety of inhaled magnesium sulphate in combination with standard treatment in patients with moderate or severe COVID-19: A structured summary of a study protocol for a randomised controlled trial

Guitti Pourdowlat, Seyed Ruhollah Mousavinasab, Behrooz Farzanegan, Alireza Kashefizadeh, Zohreh Akhoundi Meybodi, Maedeh Jafarzadeh, Shadi Baniasadi

Diabetes management intervention studies: lessons learned from two studies

Bettina Petersen, Iris Vesper, Bernhild Pachwald, Nicole Dagenbach, Sina Buck, Delia Waldenmaier, Lutz Heinemann

Managing clinical trials during COVID-19: experience from a clinical research facility

Frances Shiely, Jean Foley, Amy Stone, Emma Cobbe, Shaunagh Browne, Ellen Murphy, Maeve Kelsey, Joanne Walsh-Crowley, Joseph A. Eustace

Clip placement to prevent delayed bleeding after colonic endoscopic mucosal resection (CLIPPER): study protocol for a randomized controlled trial

Ayla S. Turan, Leon M. G. Moons, Ramon-Michel Schreuder, Erik J. Schoon, Jochim S. Terhaar sive Droste, Ruud W. M. Schrauwen, Jan Willem Straathof, Barbara A. J. Bastiaansen, Matthijs P. Schwartz, Wouter L. Hazen, Alaa Alkhalaf, Daud Allajar, Muhammed Hadithi, Bas W. van der Spek, Dimitri G. D. N. Heine, Adriaan C. I. T. L. Tan, Wilmar de Graaf, Jurjen J. Boonstra, Fia J. Voogd, Robert Roomer, Rogier J. J. de Ridder, Wietske Kievit, Peter D. Siersema, Paul Didden, Erwin J. M. van Geenen

In silico imaging clinical trials: cheaper, faster, better, safer, and more scalable

Aldo Badano

Mentoring upcoming researchers for non-communicable diseases’ research and practice in Malawi

Adamson S. Muula, Mina C. Hosseinipour, Martha Makwero, Johnstone Kumwenda, Prosper Lutala, Mary Mbeba, Sarah Rylance, Collins Mitambo, Moffat Nyirenda

Statistical analysis plan for management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: the SingHypertension pragmatic cluster randomized controlled trial

John C. Allen Jr, Benjamin Halaand, Rupesh M. Shirore, Tazeen H. Jafar

The Chinese herbal formula Huoxiang Zhengqi for atopic dermatitis with dampness pattern (CHARM): a study protocol for a double-blinded randomized controlled trial

Meiling Xuan, Xiaohui Guo, Hongyi Li, Ting Xie, Xiumei Mo, Zehuai Wen

Mingjing granule, a traditional Chinese medicine in the treatment of neovascular age-related macular degeneration: study protocol for a randomized controlled trial

Yamin Li, Lina Liang, Torkel Snellingen, Kai Xu, Yun Gao, Fengmei Zhang, Chengwei Guo, Tao Zuo, Fengming Liang, Xiaoping Yao, Xueyan Yang

Utilising benefit-risk assessments within clinical trials—a protocol for the BRAINS project

Nikki Totton, Steven Julious, Dyfrig Hughes, Jonathan Cook, Katie Biggs, Lizzie Coates, Andrew Cook, Catherine Hewitt, Simon Day

Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial

Elena Diago-Sempere, José Luis Bueno, Aránzazu Sancho-López, Elena Múñez Rubio, Ferrán Torres, Rosa Malo de Molina, Ana Fernández-Cruz, Isabel Salcedo de Diego, Ana Velasco-Iglesias, Concepción Payares-Herrera, Inmaculada Casas Flecha, Cristina Avendaño-Solà, Rafael Duarte Palomino, Antonio Ramos-Martínez, Belén Ruiz-Antorán

Evaluation of the efficacy and safety of icatibant and C1 esterase/kallikrein inhibitor in severe COVID-19: study protocol for a three-armed randomized controlled trial

Eli Mansour, Flávia F. Bueno, José C. de Lima-Júnior, Andre Palma, Milena Monfort-Pires, Bruna Bombassaro, Eliana P. Araujo, Ana Flavia Bernardes, Raisa G. Ulaf, Thyago A. Nunes, Luciana C. Ribeiro, Antônio Luís E. Falcão, Thiago Martins Santos, Plinio Trabasso, Rachel P. Dertkigil, Sergio S. Dertkigil, Rafael P. Maia, Tatiana Benaglia, Maria Luiza Moretti, Licio A. Velloso

Intersectoral care management for older people with cognitive impairment during and after hospital stays [intersec-CM]: study protocol for a process evaluation within a randomised controlled trial

Terese Dehl, Ulf Sauerbrey, Adina Dreier-Wolfgramm, Angela Nikelski, Nino Chikhradze, Armin Keller, Jessica Laufer, Fanny Schumacher-Schoenert, Stefan Kreisel, Jochen René Thyrian, Wolfgang Hoffmann, Horst Christian Vollmar

Effectiveness of electroacupuncture for thin endometrium in infertile women: study protocol for a single-blind, randomized controlled trial

Fangyuan Li, Hua Lu, Xinxin Wang, Qi Zhang, Qianchen Liu, Tong Wang

Acupuncture for Hashimoto thyroiditis: study protocol for a randomized controlled trial

Shanze Wang, Jiping Zhao, Weimei Zeng, Wanqing Du, Tenghui Zhong, Hui Gao, Yi Xiao, Chao Yang

Efficacy of silver needle therapy for the treatment of chronic nonspecific low back pain: a prospective, single-center, randomized, parallel-controlled clinical trial

Xuesong Hu, Shaoxing Dong, Bing Zhang, Xuan Wang, Yanwei Yin, Chuansheng Liu, Junmin Yu, Xing Wu, Fenghu Xu, Chao Meng

Commentary on ‘Exclusion rates in randomized trials of treatments for physical conditions: a systematic review’

Anna Ugalde, Nicole Kiss, Patricia M. Livingston, Nicole Rankin

The coArtHA trial—identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial

Herry Mapesi, Ravi Gupta, Herieth Ismael Wilson, Blaise Lukau, Alain Amstutz, Aza Lyimo, Josephine Muhairwe, Elizabeth Senkoro, Theonestina Byakuzana, Madavida Mphunyane, Moniek Bresser, Tracy Renée Glass, Mark Lambiris, Günther Fink, Winfrid Gingo, Manuel Battegay, Daniel Henry Paris, Martin Rohacek, Fiona Vanobberghen, Niklaus Daniel Labhardt, Thilo Burkard, Maja Weisser

Quantifying the advantages of conducting a prospective meta-analysis (PMA): a case study of early childhood obesity prevention

A. L. Seidler, K. E. Hunter, D. Espinoza, S. Mihrshahi, L. M. Askie, Lisa M. Askie, David Espinoza, Andrew Martin, Lynne A. Daniels, Seema Mihrshahi, Rachael Taylor, Li Ming Wen, Karen Campbell, Kylie D. Hesketh, Chris Rissel, Barry Taylor, Anthea Magarey, Anna Lene Seidler, Kylie E. Hunter, Louise A. Baur

The acupoint herbal plaster for the prevention and treatment of postoperative nausea and vomiting after PLIF with general anesthesia: study protocol for a multicenter randomized controlled trial

Huiqing Xu, Xu Wei, Ranxing Zhang, Ling Li, Zhijun Zhang, Ruo Jia, Xiaofei Zhang, Xiumei Gao, Xicheng Dong, Junjun Pan

STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

Bastiaan C. ter Meulen, Johanna M. van Dongen, Marinus van der Vegt, Henry C. Weinstein, Raymond W. J. G. Ostelo

Effectiveness of a pathway-driven eHealth-based integrated care model (PEICM) for community-based hypertension management in China: study protocol for a randomized controlled trial

Zheyu Wang, Chengling Li, Wencai Huang, Yan Chen, Yuqiong Li, Libin Huang, Mei Zhang, Dan Wu, Li Wang, Huilong Duan, Jiye An, Ning Deng

Oral melatonin as a new tool for neuroprotection in preterm newborns: study protocol for a randomized controlled trial

Francesca Garofoli, Stefania Longo, Camilla Pisoni, Patrizia Accorsi, Micol Angelini, Salvatore Aversa, Camilla Caporali, Sara Cociglio, Annalisa De Silvestri, Elisa Fazzi, Vittoria Rizzo, Chryssoula Tzialla, Marco Zecca, Simona Orcesi

Effect of early sleep apnoea treatment with adaptive servo-ventilation in acute stroke patients on cerebral lesion evolution and neurological outcomes: study protocol for a multicentre, randomized controlled, rater-blinded, clinical trial (eSATIS: early Sleep Apnoea Treatment in Stroke)

Simone B. Duss, Anne-Kathrin Brill, Sébastien Baillieul, Thomas Horvath, Frédéric Zubler, Dominique Flügel, Georg Kägi, Gabriel Benz, Corrado Bernasconi, Sebastian R. Ott, Lyudmila Korostovtseva, Yurii Sviryaev, Farid Salih, Matthias Endres, Renaud Tamisier, Haralampos Gouveris, Yaroslav Winter, Niklaus Denier, Roland Wiest, Marcel Arnold, Markus H. Schmidt, Jean-Louis Pépin, Claudio L. A. Bassetti

A master protocol to investigate a novel therapy acetyl-l-leucine for three ultra-rare neurodegenerative diseases: Niemann-Pick type C, the GM2 gangliosidoses, and ataxia telangiectasia

T. Fields, M. Patterson, T. Bremova-Ertl, G. Belcher, I. Billington, G. C. Churchill, W. Davis, W. Evans, S. Flint, A. Galione, U. Granzer, J. Greenfield, R. Karl, R. Kay, D. Lewi, T. Mathieson, T. Meyer, D. Pangonis, F. M. Platt, L. Tsang, C. Verburg, M. Factor, M. Strupp

Efficacy and safety of berberine for dyslipidemia: study protocol for a randomized double-blind placebo-controlled trial

Ying Zhao, Yuan-Yuan Yang, Bao-Lin Yang, Ya-Wei Du, Da-Wei Ren, Hong-Mei Zhou, Jing Wang, Hui-Min Yang, Yao-Xian Wang, Ying-Ying Zhang, Sheng-Xian Wu

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

Moses Badio, Edouard Lhomme, Mark Kieh, Abdoul Habib Beavogui, Stephen B. Kennedy, Seydou Doumbia, Bailah Leigh, Samba O. Sow, Alpha Diallo, Daniela Fusco, Matthew Kirchoff, Monique Termote, Renaud Vatrinet, Deborah Wentworth, Helène Esperou, H. Clifford Lane, Jerome Pierson, Deborah Watson-Jones, Céline Roy, Eric D’Ortenzio, Brian Greenwood, Genevieve Chêne, Laura Richert, James D. Neaton, Yazdan Yazdanpanah, Coulibaly Abdoulaye, Jamilia Aboulhab, Pauline Akoo, Esther Akpa, Robert Akpata, Sara Albert, Boni Maxime Ale, Benetta C. Andrews, Stephane Anoma, Saw-San Assiandi, Augustin Augier, Ken Awuondo, Moses Badio, Aminata Bagayoko, Nyasha Bakare, Abby Balde, Lamin Molecule Bangura, Kesha Barrington, Eric Barte de Saint Fare, Beth Baseler, Ali Bauder, Claire Bauduin, Luke Bawo, Abdoul Habib Beavogui, Michael Belson, Marion Bererd, Teedoh Beyslow, Blandine Binachon, Julie Blie, Viki Bockstal, Youba Boire, Patricia Boison, Fatorma Bolay, Aliou Boly, Anne Gael Borg, Donna Bowers, Sarah Browne, Barbara Cagniard, Kelly Cahill, Aissata Abdoulaye Camara, Keira Camara, Modet Camara, Cécilia Campion, Jennifer Cash, Siew Pin Chai, Francois Chambelin, Keita Chieck, Geneviève Chêne, Séverine Ciancia, Papa Ndiaga Cisse, Elfrida Clide, Céline Colin, Beth-Ann Coller, Djélikan Siaka Conde, Katherine Cone, Laurie Connor, Nicholas Connor, Joseph Boye Cooper, Sandrine Couffin-Cardiergues, Fatoumata Coulibaly, Mariam Coulibaly, Sandrine Dabakuyo-Yonli, Djeneba Dabitao, Thierry Damerval, Bionca Davis, Gibrilla Fadlu Deen, Eline Dekeyster, Jean-François Delfraissy, Christelle Delmas, Rokia Dembele, Mahamadou Diakite, Alpha Diallo, Mamadou Saliou Diallo, Ayouba Diarra, Oualy Diawara, Bonnie Dighero-kemp, Samba Diop, Waly Diouf, Laurie Doepel, Eric D’Ortenzio, Seydou Doumbia, Moussa Moise Doumbia, Macaya Douoguih, Alain DuChêne, Michael Duvenhage, Risa Eckes Eckes, Avril Egan, Luisa Enria, Hélène Espérou, Cécile Etienne, Allison Eyler, Sylvain Faye, José Fernandez, Suzanne Fleck, Vemy Fofana, Kokulo Franklin, Daniela Fusco, Auguste Gaddah, Marylène Gaignet, Katherine Gallagher, Julia Garcia Gozalbes, Greg Grandits, Maima Gray, Brian Greenwood, Astrid Greijer, Louis Grue, Birgit Grund, Oumar Guindo, Swati Gupta, Fadima Haidara, Benjamin Hamze, Emma Hancox, Gavin Hart, Jean-Christophe Hébert, Esther Heijnen, Patricia Hensley, Lisa Hensley, Elisabeth Higgs, Trudi Hilton, Preston Holley, Marie Hoover, Natasha Howard, Melissa Hughes, Dicko Ilo, Jen Imes, Skip Irvine, David Ishola, Will Jacob, Yvonne Jato, Melvin Johnson, Morrison Jusu, Aboubacar Sidiki Kaba, Myriam Kante, Judith Katoudi, Sakoba Keita, Stephen Kennedy, Babajide Jide Keshinro, Brian Khon, Hassan Kiawu, Mark Kieh, Matt Kirchoff, Mamoudou Kodio, Lamine Koivogui, Tania Kombi, Stacy Kopka, Dickens Kowuors, Christine Lacabaratz, Boris Lacarra, Laurie Lambert, Cliff Lane, Shona Lee, Shelley Lees, Annabelle Lefevre, Bailah Leigh, Frederic Lemarcis, Yves Lévy, Claire Levy-Marchal, Jemilla Lewally, Maarten Leyssen, Edouard Lhomme, Ken Liu, Brett Lowe, Julia Lysander, Claire Madelaine, Ibrah Mahamadou, Daniela Manno, Johnathan Marchand, Siegfried Marynissen, Moses B.F. Massaquoi, Laure Masson, Charly Matard, Onorato Matthew, John McCullough, Noemie Mercier, Pauline Michavila, Tracey Miller, Alejandra Miranda, Soumaya Mohamed, Tom Mooney, Hans Morsch, Dally Muamba, Rita Lukoo Ndamenyaa, James Neaton, Désiré Neboua, Micki Nelson, Kevin Newell, Vinh-kim Nguyen, Leslie Nielsen, Millimouno Niouma, Kim Offergeld, Matthew Onorato, Uma Onwuchekwa, Susan Orsega, Inmaculada Ortega-Perez, Cynthia Osborne, Tuda Otieno, Sushma Patel, Nathan Peiffer-Smadj, Robert Phillips, Jerome Pierson, Peter Piot, Micheal Piziali, Stephany Pong, Calvin Proffitt, Alexandre Quach, Corina Ramers-verhoeven, Nadeeka Randunu, Laura Richert, Priscille Rivière, Cynthia Robinson, Griet Van Roey, Céline Roy, Amy Falk Russell, Mohamed Samai, Sibiry Samake, Ballan Sangare, Ibrahim Sanogo, Yeya Sadio Sarro, Sadio Sarro, Mélanie Saville, Serge Sawadogo, Maxime Schvartz, Christine Schwimmer, Fatou Secka, Jacques Seraphin, Denise Shelley, Sophia Siddiqui, Jakub Simon, Shelly Simpson, Billy Muyisa Sivahera, Irvine Skip, Karen Slater, Mary Smolskis, Elizabeth Smout, Emily Snowden, Anne-Aygline Soutthiphong, Samba Sow, Ydrissa Sow, Daniel Splinter, Simone Spreng, Helen Stapleton, Jeroen Stoop, Mary Sweeney, Sienneh Tamba, Mili Tapia, Jemee Tegli, Monique Termote, Rodolphe Thiebaut, Greg Thompson, John Tierney, Abdoulaye Touré, Stacey Traina, Awa Traore, Moussa Traore, Tijili Tyee, David Vallée, Katrien V Van Der Donck, Renaud Vatrinet, Nadia Verbruggen, Corine Vincent, Susan Vogel, Cedrick Wallet, Deborah Watson-Jones, Deborah Wentworth, Cecelia Wesseh, Jimmy Whitworth, Aurelie Wiedemann, Wouter Willems, Julian Williams, Barthalomew Wilson, Njoh Wissedi, Jayanthi Wolf, Ian Woods, Alie Wurie, Delphine Yamadjako, Marcel Yaradouno, Yazdan Yazdanpanah, Zara Zeggani

Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial

Rezvan Ahmadi, Benito Campos, Mohammad Mehdi Hajiabadi, Colette Doerr-Harim, Solveig Tenckhoff, Dirk Rasche, Andreas Unterberg, Jan Vesper, Tom Bruckner, Volker Tronnier

Completeness and accuracy of national cancer and death registration for outcome ascertainment in trials—an ovarian cancer exemplar

Jatinderpal K. Kalsi, Andy Ryan, Aleksandra Gentry-Maharaj, Danielle Margolin-Crump, Naveena Singh, Matthew Burnell, Elizabeth Benjamin, Sophia Apostolidou, Mariam Habib, Susan Massingham, Chloe Karpinskyj, Robert Woolas, Martin Widschwendter, Lesley Fallowfield, Stuart Campbell, Steven Skates, Alistair McGuire, Max Parmar, Ian Jacobs, Usha Menon

Acetate Ringer’s solution versus 0.9% saline for septic patients: study protocol for a multi-center parallel controlled trial

Fang Liu, Jing Zhang, Yuan Zhu, Lianjiu Su, Yiming Li, Li He, Li Yu, Zhiyong Peng

Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial

Guillaume Marquis-Gravel, Holly Robertson, W. Schuyler Jones, Danielle Riley, Daniel E. Ford, David Crenshaw, Yvonne A. Joosten, Lindsey Rudov, Adrian F. Hernandez, Rachel Hess

Evaluating the effect of immersive virtual reality technology on gait rehabilitation in stroke patients: a study protocol for a randomized controlled trial

Huihui Cai, Tao Lin, Lina Chen, Huidan Weng, Ruihan Zhu, Ying Chen, Guoen Cai

Early use of corticosteroids in non-critical patients with COVID-19 pneumonia (PREDCOVID): a structured summary of a study protocol for a randomised controlled trial

Mauricio Salinas, Paulette Andino, Leonor Palma, Javiera Valencia, Elizabeth Figueroa, Jhonatan Ortega

Safety and efficacy of normobaric oxygenation on rescuing acute intracerebral hemorrhage-mediated brain damage—a protocol of randomized controlled trial

Zhiying Chen, Jiayue Ding, Xiaoqin Wu, Bing Bao, Xianming Cao, Xiangbin Wu, Xiaoping Yin, Ran Meng

Community-based intervention for cervical cancer screening uptake in a semi-urban area of Pokhara Metropolitan, Nepal (COBIN-C): study protocol for a cluster-randomized controlled trial

Aamod Dhoj Shrestha, Dinesh Neupane, Sarita Ghimire, Christine Campbell, Per Kallestrup

Chinese herbal formula Xuefu Zhuyu for primary dysmenorrhea patients (CheruPDYS): a study protocol for a randomized placebo-controlled trial

Geng Li, Zhe Zhang, Li Zhou, Shaojun Liao, Jing Sun, Yinghua Liu, Xin Wang, Zehuai Wen

Correction to: Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN’ (REGAIN): a structured summary of a study protocol for a randomised controlled trial

Gordon McGregor, Harbinder Sandhu, Julie Bruce, Bartholomew Sheehan, David McWilliams, Joyce Yeung, Christina Jones, Beatriz Lara, Jessica Smith, Chen Ji, Elaine Fairbrother, Stuart Ennis, Peter Heine, Sharisse Alleyne, Jonathan Guck, Emma Padfield, Rachel Potter, James Mason, Ranjit Lall, Kate Seers, Martin Underwood

Correction to: Navigate: a study protocol for a randomised controlled trial of an online treatment decision aid for men with low-risk prostate cancer and their partners

Penelope Schofield, Karla Gough, Amelia Hyatt, Alan White, Mark Frydenberg, Suzanne Chambers, Louisa G. Gordon, Robert Gardiner, Declan G. Murphy, Lawrence Cavedon, Natalie Richards, Barbara Murphy, Stephen Quinn, Ilona Juraskova

Evaluation of a school-based intervention to promote mental health of refugee youth in Sweden (The RefugeesWellSchool Trial): study protocol for a cluster randomized controlled trial

Natalie Durbeej, Serena McDiarmid, Anna Sarkadi, Inna Feldman, Raija-Leena Punamäki, Reeta Kankaanpää, Arnfinn Andersen, Per Kristian Hilden, An Verelst, Ilse Derluyn, Fatumo Osman

Effects of controlled hypotension with restrictive transfusion on intraoperative blood loss and systemic oxygen metabolism in elderly patients who underwent lumbar fusion

Xiaodong Qiu, Zhiying Tan, Wenhao Tang, Hui Ye, Xinjian Lu

Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system—lessons learned and recommendations

David T. Huang, Bryan J. McVerry, Christopher Horvat, Peter W. Adams, Scott Berry, Meredith Buxton, Gilles Clermont, William Garrard, Timothy D. Girard, Ghady Haidar, Andrew J. King, Kelsey Linstrum, Salim Malakouti, Florian B. Mayr, Erin K. McCreary, Stephanie K. Montgomery, Christopher W. Seymour, Alexandra Weissman, Derek C. Angus

Histological, radiological, and clinical outcomes of sinus floor elevation using a lateral approach for pre-/post-extraction of the severely compromised maxillary molars: a study protocol for a randomized controlled trial

Zhaoguo Yue, Qi Liu, Haidong Zhang, Jingwen Yang, Jianxia Hou

Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study

Niranjan S. Karnik, Cynthia I. Campbell, Megan E. Curtis, David A. Fiellin, Udi Ghitza, Kathryn Hefner, Yih-Ing Hser, R. Kathryn McHugh, Sean M. Murphy, Sterling M. McPherson, Landhing Moran, Larissa J. Mooney, Li-Tzy Wu, Dikla Shmueli-Blumberg, Matisyahu Shulman, Robert P. Schwartz, Kari A. Stephens, Katherine E. Watkins, John Marsden

Letter to the Editor: Problems with studying community-level pesticide storage to prevent suicide

Aastha Sethi, Michael Eddleston

Augmentation of EMDR with multifocal transcranial current stimulation (MtCS) in the treatment of fibromyalgia: study protocol of a double-blind randomized controlled exploratory and pragmatic trial

I. Gardoki-Souto, O. Martín de la Torre, B. Hogg, D. Redolar-Ripoll, A. Valiente-Gómez, L. Martínez Sadurní, J. M. Blanch, W. Lupo, V. Pérez, J. Radua, B. L. Amann, A. Moreno-Alcázar

Bioavailable turmeric extract for knee osteoarthritis: a randomized, non-inferiority trial versus paracetamol

Shubha Singhal, Nazer Hasan, Kirti Nirmal, Rohit Chawla, Shalini Chawla, Bhupinder Singh Kalra, Anil Dhal

The effectiveness of Tai Chi on the depressive symptom of young adults with subthreshold depression: a study protocol for a randomized controlled trial

Xiaoting Xie, Jian Song, Jingfang Zhu, Mengyu Han, Youze He, Jia Huang, Jing Tao, Jingsong Wu

Effect of physical exercise in bariatric surgery patients: protocol of a randomized controlled clinical trial

Andrea Herrera-Santelices, Andrea Tabach-Apraiz, Karen Andaur-Cáceres, Antonio Roberto Zamunér

Low-carbohydrate dietary pattern on glycemic outcomes trial (ADEPT) among individuals with elevated hemoglobin A1c: study protocol for a randomized controlled trial

Kirsten S. Dorans, Lydia A. Bazzano, Lu Qi, Hua He, Lawrence J. Appel, Jonathan M. Samet, Jing Chen, Katherine T. Mills, Bernadette T. Nguyen, Matthew J. O’Brien, Gabriel I. Uwaifo, Jiang He

Homeopathy for Covid-19 in Primary Care: A structured summary of a study protocol for a randomized controlled trial

Ubiratan Cardinalli Adler, Maristela Schiabel Adler, Livia Mitchiguian Hotta, Ana Elisa Madureira Padula, Amarilys de Toledo Cesar, José Nelson Martins Diniz, Crislaine Aparecida Antonio Mestre, Katia Regina Spiller, Lidiamara Soares, Helen de Freitas Santos, Edson Zangiacomi Martinez

Naltrexone treatment for prolonged grief disorder: study protocol for a randomized, triple-blinded, placebo-controlled trial

James Gang, James Kocsis, Jonathan Avery, Paul K. Maciejewski, Holly G. Prigerson

High-dose vitamin D versus placebo to prevent complications in COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial (CARED-TRIAL)

Javier Mariani, Carlos Tajer, Laura Antonietti, Felipe Inserra, León Ferder, Walter Manucha

Convalescent plasma therapy for COVID-19 patients: a protocol of a prospective meta-analysis of randomized controlled trials

Lajos Szakó, Nelli Farkas, Szabolcs Kiss, Szilárd Váncsa, Noémi Zádori, Nóra Vörhendi, Bálint Erőss, Péter Hegyi, Hussain Alizadeh

Feasibility study protocol of a pragmatic, randomised controlled pilot trial: membrane sweeping to prevent post-term pregnancy—the MILO Study

Elaine M. Finucane, Linda Biesty, Deirdre Murphy, Amanda Cotter, Eleanor Molloy, Martin O’Donnell, Shaun Treweek, Paddy Gillespie, Marian Campbell, John J. Morrison, Alberto Alvarez-Iglesias, Gill Gyte, Declan Devane

Barriers impacting the POINT pragmatic trial: the unavoidable overlap between research and intervention procedures in “real-world” research

Allyson L. Dir, Dennis P. Watson, Matthew Zhiss, Lisa Taylor, Bethany C. Bray, Alan McGuire

Management of Renin-Angiotensin-Aldosterone System blockade in patients admitted to hospital with confirmed coronavirus disease (COVID-19) infection (The McGill RAAS-COVID- 19): A structured summary of a study protocol for a randomized controlled trial

Mona Aflaki, Alexandria Flannery, João Pedro Ferreira, Matthew Pellan Cheng, Nadine Kronfli, Ariane Marelli, Faiez Zannad, James Brophy, Jon Afillalo, Thao Huynh, Nadia Giannetti, Amal Bessissow, Justin A. Ezekowitz, Renato D. Lopes, Andrew P. Ambrosy, Morgan Craig, Abhinav Sharma

A Phase I/II Clinical Trial to evaluate the efficacy of baricitinib to prevent respiratory insufficiency progression in onco-hematological patients affected with COVID19: A structured summary of a study protocol for a randomised controlled trial

G. Moreno-González, A. Mussetti, A. Albasanz-Puig, I. Salvador, A. Sureda, C. Gudiol, R. Salazar, M. Marin, M. Garcia, V. Navarro, I. de la Haba Vaca, E. Coma, G. Sanz-Linares, X. Dura, S. Fontanals, G. Serrano, C. Cruz, R. Mañez

Remote data collection during COVID-19 restrictions: an example from a refugee and asylum-seeker participant group in the UK

Lauren Walker, Della Bailey, Rachel Churchill, Emily Peckham

Effects of different wavelengths of invasive laser acupuncture on chronic non-specific low back pain: a study protocol for a pilot randomized controlled trial

Jae-Hong Kim, Chang-Su Na, Gwang-Cheon Park, Jeong-Soon Lee

Using ActionADE to create information continuity to reduce re-exposures to harmful medications: study protocol for a randomized controlled trial

Jeffrey P. Hau, Penelope M. A. Brasher, Amber Cragg, Serena Small, Maeve Wickham, Corinne M. Hohl

Transitional care from skilled nursing facilities to home: study protocol for a stepped wedge cluster randomized trial

M. Toles, C. Colón-Emeric, L. C. Hanson, M. Naylor, M. Weinberger, J. Covington, J. S. Preisser

Robotic natural orifice specimen extraction surgery versus traditional robotic-assisted surgery (NOTR) for patients with colorectal cancer: a study protocol for a randomized controlled trial

Rui Luo, Fangfang Zheng, Haobo Zhang, Weiquan Zhu, Penghui He, Dongning Liu

Correction to: Statistical analysis plan for management of hypertension and multiple risk factors to enhance cardiovascular health in Singapore: the SingHypertension pragmatic cluster randomized controlled trial

John C. Allen Jr, Benjamin Halaand, Rupesh M. Shirore, Tazeen H. Jafar

Efficacy and safety of Shi-style cervical manipulation therapy for treating acute and subacute neck pain: study protocol for a randomized controlled trial

Mingcai Zhang, Guoqing Du, Congying Liu, Wei Li, Jiayu Yang, Bo Chen, Xiaoyue Yu, Yizhe Xiong, Enyu Jiang, Ningyang Gao, Sumin Jiang, Zhenqiu Xu, Xiang Wang, Hongsheng Zhan

Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

J. Dubreucq, M. Faraldo, M. Abbes, B. Ycart, H. Richard-Lepouriel, S. Favre, F. Jermann, J. Attal, M. Bakri, T. Cohen, C. Cervello, I. Chereau, C. Cognard, M. De Clercq, A. Douasbin, J. Y. Giordana, E. Giraud-Baro, N. Guillard-Bouhet, E. Legros-Lafarge, M. Polosan, A. Pouchon, M. Rolland, N. Rainteau, C. Roussel, C. Wangermez, P. T. Yanos, P. H. Lysaker, N. Franck

COHESION: core outcomes in neonatal encephalopathy (protocol)

Fiona A. Quirke, Patricia Healy, Elaine Ní Bhraonáin, Mandy Daly, Linda Biesty, Tim Hurley, Karen Walker, Shireen Meher, David M. Haas, Frank H. Bloomfield, Jamie J. Kirkham, Eleanor J. Molloy, Declan Devane

Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

Iwein Gyselinck, Laurens Liesenborghs, Ewout Landeloos, Ann Belmans, Geert Verbeke, Peter Verhamme, Robin Vos, W. Janssens, Wim Janssens, Robin Vos, Iwein Gyselinck, Eef Vanderhelst, Bernard Bouckaert, Patrick Alexander, Nikolaas De Mayer, Emmanuelle Papleux, Ann-Catherine Soenen, Aurelie Derweduwe, Kurt Vandeurzen, Jean-Benoît Martinot, Pieter Goeminne, Hong Nguyen, Charles Pilette, Rob Schildermans, Lynn Decoster

A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial

Sohaib Ashraf, Shoaib Ashraf, Moneeb Ashraf, Muhammad Ahmad Imran, Larab Kalsoom, Uzma Nasim Siddiqui, Iqra Farooq, Muhammad Ghufran, Romaisa Arshad Khokhar, Muhammad Kiwan Akram, Iqra Shahid, Muhammad Sohaib Ur Rehman, Rutaba Akmal, Arbaz Tahir, Ayesha Zahid, Sidra Ashraf, Sundas Rafique, Nazish Matti, Muhammad Faisal Nadeem, Ayesha Humayun, Amber Malik, Qazi Abdul Saboor, Ali Ahmad, Muhammad Ashraf, Mateen Izhar

Randomized trial of community health worker-led decision coaching to promote shared decision-making for prostate cancer screening among Black male patients and their providers

Danil V. Makarov, Zachary Feuer, Shannon Ciprut, Natalia Martinez Lopez, Angela Fagerlin, Michele Shedlin, Heather T. Gold, Huilin Li, Gina Lynch, Rueben Warren, Peter Ubel, Joseph E. Ravenell

Acceptability and feasibility of a community-based strength, balance, and Tai Chi rehabilitation program in improving physical function and balance of patients after total knee arthroplasty: study protocol for a pilot randomized controlled trial

Cathy W. T. Lo, Matthew A. Brodie, William W. N. Tsang, Chun-Hoi Yan, Priscillia L. Lam, Chun-Ming Chan, Stephen R. Lord, Arnold Y. L. Wong

A double blinded placebo controlled comparative clinical trial to evaluate the effectiveness of Siddha medicines, Kaba Sura Kudineer (KSK) & Nilavembu Kudineer (NVK) along with standard Allopathy treatment in the management of symptomatic COVID 19 patients - a structured summary of a study protocol for a randomized controlled trial

Anurag Srivastava, Manickavasagam Rengaraju, Saurabh Srivastava, Vimal Narayan, Vivek Gupta, Rashmi Upadhayay

Impact of intravenous lidocaine on clinical outcomes of patients with ARDS during COVID-19 pandemia (LidoCovid): A structured summary of a study protocol for a randomised controlled trial

Marie Muller, François Lefebvre, Marie-Line Harlay, Ludovic Glady, Guillaume Becker, Charlotte Muller, Ouafaa Aberkane, Mira Tawk, Madoé Julians, Arnaud Romoli, Stéphane Hecketsweiler, Francis Schneider, Julien Pottecher, Thiên-Nga Chamaraux-Tran

M.I.C.E—Mental Health Intervention for Children with Epilepsy: a randomised controlled, multi-centre clinical trial evaluating the clinical and cost-effectiveness of MATCH-ADTC in addition to usual care compared to usual care alone for children and young people with common mental health disorders and epilepsy—study protocol

Sophie D. Bennett, J. Helen Cross, Anna E. Coughtrey, Isobel Heyman, Tamsin Ford, Bruce Chorpita, Rona Moss-Morris, Sarah Byford, Emma Dalrymple, Colin Reilly, Terence Stephenson, Caroline Doré, Sophia Varadkar, James Blackstone, Kashfia Chowdhury, Poushali Ganguli, Liz Deane, Peter Fonagy, Jonathan Smith, Roz Shafran

Effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster-randomized trial

William Lumu, Davis Kibirige, Ronald Wesonga, Silver Bahendeka

Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial

K. Seidensaal, M. Kieser, A. Hommertgen, C. Jaekel, S. B. Harrabi, K. Herfarth, G. Mechtesheimer, B. Lehner, M. Schneider, H. Nienhueser, S. Fröhling, G. Egerer, J. Debus, M. Uhl

Efficacy of modified Banxia Xiexin decoction in the management of Wei-Pi syndrome (postprandial distress syndrome): study protocol for a randomized, waitlist-controlled trial

Sai Ho Sin, Jing Wu, Yuchen Kang, Kar Hung Kevin Yip, Ngo Suet Kong, Hei Wan, Bacon Fung Leung Ng, Haiyong Chen

Fluorescent cystoscopy-assisted en bloc transurethral resection versus conventional transurethral resection in patients with non-muscle invasive bladder cancer: study protocol of a prospective, open-label, randomized control trial (the FLEBER study)

Makito Miyake, Nobutaka Nishimura, Takashi Inoue, Shota Suzuki, Tomomi Fujii, Takuya Owari, Shunta Hori, Yasushi Nakai, Michihiro Toritsuka, Hitoshi Nakagawa, Shinji Tsukamoto, Satoshi Anai, Kazumasa Torimoto, Tatsuo Yoneda, Nobumichi Tanaka, Kiyohide Fujimoto

Comparative study of the effect of neuromuscular electrical stimulation and oral administration of branched-chain amino acid on preventing sarcopenia in patients after living-donor liver transplantation: study protocol for an open-label randomized controlled trial

Masafumi Haraguchi, Kunihiro Ichinose, Hisamitsu Miyaaki, Masatoshi Hanada, Masanori Fukushima, Ryu Sasaki, Satoshi Miuma, Takanobu Hara, Tota Kugiyama, Akihiko Soyama, Masaaki Hidaka, Ayumi Tsuji, Rintaro Yano, Motohiro Sekino, Hideaki Takahata, Susumu Eguchi, Kazuhiko Nakao

The effect of lifestyle and risk factor modification on occlusive peripheral arterial disease outcomes: standard healthcare vs structured programme—for a randomised controlled trial protocol

M. Elfghi, F. Jordan, D. Dunne, I. Gibson, J. Jones, G. Flaherty, S. Sultan, W. Tawfick

Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Anne Christin Rahn, Lisa Wenzel, Andrea Icks, Alexander Stahmann, Jutta Scheiderbauer, Kristina Grentzenberg, Markus Vomhof, Joseph Montalbo, Tim Friede, Christoph Heesen, Sascha Köpke

Transcutaneous electrical acupoint stimulation for high-normal blood pressure: study protocol for a randomized controlled pilot trial

Yu Wang, Guang-Xia Shi, Zhong-Xue Tian, Jun-Hong Liu, You-Sheng Qi, Jian-Feng Tu, Jing-Wen Yang, Li-Qiong Wang, Cun-Zhi Liu

MR CLEAN-NO IV: intravenous treatment followed by endovascular treatment versus direct endovascular treatment for acute ischemic stroke caused by a proximal intracranial occlusion—study protocol for a randomized clinical trial

Kilian M. Treurniet, Natalie E. LeCouffe, Manon Kappelhof, Bart J. Emmer, Adriaan C. G. M. van Es, Jelis Boiten, Geert J. Lycklama, Koos Keizer, Lonneke S. F. Yo, Hester F. Lingsma, Wim H. van Zwam, Inger de Ridder, Robert J. van Oostenbrugge, Aad van der Lugt, Diederik W. J. Dippel, Jonathan M. Coutinho, Yvo B. W. E. M. Roos, Charles B. L. M. Majoie

Multi-Round compared to Real-Time Delphi for consensus in core outcome set (COS) development: a randomised trial

Fiona A. Quirke, Patricia Healy, Elaine Ní Bhraonáin, Mandy Daly, Linda Biesty, Tim Hurley, Karen Walker, Shireen Meher, David M. Haas, Frank H. Bloomfield, Jamie J. Kirkham, Eleanor J. Molloy, Declan Devane

Ethical care requires pragmatic care research to guide medical practice under uncertainty

Tim E. Darsaut, Jean Raymond

How effective are three methods of teaching oral hygiene for adolescents undergoing orthodontic treatment? The MAHO protocol: an RCT comparing visual, auditory and kinesthetic methods

Alisée Le Fouler, Sylvie Jeanne, Olivier Sorel, Damien Brézulier

Correction to: Implementation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 (REMAP-COVID) trial in a US health system—lessons learned and recommendations

Correction to: The NYCKidSeq project: study protocol for a randomized controlled trial incorporating genomics into the clinical care of diverse New York City children

Jacqueline A. Odgis, Katie M. Gallagher, Sabrina A. Suckiel, Katherine E. Donohue, Michelle A. Ramos, Nicole R. Kelly, Gabrielle Bertier, Christina Blackburn, Kaitlyn Brown, Lena Fielding, Jessenia Lopez, Karla Lopez Aguiniga, Estefany Maria, Jessica E. Rodriguez, Monisha Sebastin, Nehama Teitelman, Dana Watnick, Nicole M. Yelton, Avinash Abhyankar, Noura S. Abul-Husn, Aaron Baum, Laurie J. Bauman, Jules C. Beal, Toby Bloom, Charlotte Cunningham-Rundles, George A. Diaz, Siobhan Dolan, Bart S. Ferket, Vaidehi Jobanputra, Patricia Kovatch, Thomas V. McDonald, Patricia E. McGoldrick, Rosamond Rhodes, Michael L. Rinke, Mimsie Robinson, Arye Rubinstein, Lisa H. Shulman, Christian Stolte, Steven M. Wolf, Elissa Yozawitz, Randi E. Zinberg, John M. Greally, Bruce D. Gelb, Carol R. Horowitz, Melissa P. Wasserstein, Eimear E. Kenny

Computer-based alcohol reduction intervention for alcohol-using HIV/HCV co-infected Russian women in clinical care: study protocol for a randomized controlled trial

Ralph J. DiClemente, Jennifer L. Brown, Ariadna Capasso, Natalia Revzina, Jessica M. Sales, Ekaterina Boeva, Lyudmila V. Gutova, Nadia B. Khalezova, Nikolay Belyakov, Vadim Rassokhin

Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Edward C. Deehan, Eloisa Colin-Ramirez, Lucila Triador, Karen L. Madsen, Carla M. Prado, Catherine J. Field, Geoff D. C. Ball, Qiming Tan, Camila Orsso, Irina Dinu, Mohammadreza Pakseresht, Daniela Rubin, Arya M. Sharma, Hein Tun, Jens Walter, Christopher B. Newgard, Michael Freemark, Eytan Wine, Andrea M. Haqq

The effect of a topical combination of clonidine and pentoxifylline on post-traumatic neuropathic pain patients: study protocol for a randomized, double-blind placebo-controlled trial

Oli Abate Fulas, André Laferrière, D. Mark A. Ware, Yoram Shir, Terence J. Coderre

Efficacy of the erector spinae plane (ESP) block for quality of recovery in posterior thoraco-lumbar spinal decompression surgery: study protocol for a randomised controlled trial

Dylan T. Finnerty, Donal J. Buggy

Effects of novel diabetic therapeutic footwear on preventing ulcer recurrence in patients with a history of diabetic foot ulceration: study protocol for an open-label, randomized, controlled trial

Yun Gao, Chun Wang, Dawei Chen, Hui Huang, Lihong Chen, Guanjian Liu, Shuang Lin, Min Liu, Xiaorong Wen, Jae-Hoon Cho, Yong Chen, Yingzhu Li, Xingwu Ran

Utility of Abdominal Drain in Gastrectomy (ADiGe) Trial: study protocol for a multicenter non-inferiority randomized trial

J. Weindelmayer, V. Mengardo, A. Veltri, G. L. Baiocchi, S. Giacopuzzi, G. Verlato, G. de Manzoni

COVID-19 trials: declarations of data sharing intentions at trial registration and at publication

Rebecca Li, Megan von Isenburg, Marcia Levenstein, Stan Neumann, Julie Wood, Ida Sim

Sympathetic Nervous System and Exercise Affects Cognition in Youth (SNEACY): study protocol for a randomized crossover trial

Lauren B. Raine, Katherine McDonald, Tatsuya T. Shigeta, Shu-Shih Hsieh, Jennifer Hunt, Nathan A. Chiarlitti, Michelle Lim, Kristen Gebhardt, Nina Collins, Michael De Lisio, Sean P. Mullen, Arthur F. Kramer, Charles Hillman

Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in chronic inflammatory demyelinating polyradiculoneuropathy: protocol of an international, randomised, double-blind, placebo-controlled trial (OPTIC)

S. R. M. Bus, L. Zambreanu, A. Abbas, Y. A. Rajabally, R. D. M. Hadden, R. J. de Haan, C. A. J. M. de Borgie, M. P. Lunn, I. N. van Schaik, F. Eftimov, A. F. J. E. Vrancken, P. A. van Doorn, J. G. J. Hoeijmakers, N. Voermans, P. W. Wirtz, M. Padberg, M. de Rijk, G. Chavada, J. Miller, J. Holt

The effect of the SIMS Programme versus existing preschool oral healthcare programme on oral hygiene level of preschool children: study protocol for a cluster randomised controlled trial

Zamros Yuzadi Mohd Yusof, Nurul Hayati Anwar, Nor Azlida Mohd Nor, Mariani Md Nor, Siti Ezaleila Mustafa

Protocol for the development of a repository of individual participant data from randomised controlled trials conducted in adult care homes (the Virtual International Care Homes Trials Archive (VICHTA))

Lisa Irvine, Jennifer Kirsty Burton, Myzoon Ali, Terence J. Quinn, Claire Goodman

Study protocol: a core outcome set for perinatal interventions for congenital diaphragmatic hernia

Simen Vergote, Felix De Bie, Jan Bosteels, Holly Hedrick, James Duffy, Beverley Power, Alexandra Benachi, Paolo De Coppi, Caraciolo Fernandes, Kevin Lally, Irwin Reiss, Jan Deprest

Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial

Chenchen Liu, Dongyu Kang, Jingmei Xiao, Yuyan Huang, Xingjie Peng, Weiyan Wang, Peng Xie, Ye Yang, Jingping Zhao, Renrong Wu

MR CLEAN-LATE, a multicenter randomized clinical trial of endovascular treatment of acute ischemic stroke in The Netherlands for late arrivals: study protocol for a randomized controlled trial

F. A. V. ( Anne) Pirson, Wouter H. Hinsenveld, Robert-Jan B. Goldhoorn, Julie Staals, Inger R. de Ridder, Wim H. van Zwam, Marianne A. A. van Walderveen, Geert J. Lycklama à Nijeholt, Maarten Uyttenboogaart, Wouter J. Schonewille, Aad van der Lugt, Diederik W. J. Dippel, Yvo B. W. E. M. Roos, Charles B. L. M. Majoie, Robert J. van Oostenbrugge

A checklist-based method for improving COPD care for the elderly in general practice: study protocol for a cluster randomized controlled trial using electronic health records

Anna Kowalczyk, Izabela Zakowska, Ewa Andrzejewska, Katarzyna Kosiek, Maciek Godycki-Cwirko

Traditional Chinese medicine auricular point acupressure for the relief of pain, fatigue, and gastrointestinal adverse reactions after the injection of novel coronavirus-19 vaccines: a structured summary of a study protocol for a multicentre, three-arm, single-blind, prospective randomized controlled trial

Qinwei Fu, Hui Xie, Li Zhou, Xinrong Li, Yang Liu, Min Liu, Chaoyu Wang, Xiaocen Wang, Zhiqiao Wang, Jinfan Tang, Huan Xiao, Zhiyong Xiao, Jing Zhou, Chengzhi Feng, Li Wang, Zhimin Ao, Xi Chen, Chang Su, Xuanyu Wu, Maolan Zhao, Sihan Hu, Hanwen Lin, Jiali Huang, Guo Xu, Qinxiu Zhang, Luyun Jiang

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

Acupuncture in diabetic peripheral neuropathy—protocol for the randomized, multicenter ACUDPN trial

J. Dietzel, S. Hörder, I. V. Habermann, G. Meyer-Hamme, K. Hahn, M. Ortiz, S. Roll, K. Linde, D. Irnich, M. Hammes, R. Nögel, M. Wullinger, V. Wortman, J. Hummelsberger, S. N. Willich, S. Schröder, B. Brinkhaus

Narrative Exposure Therapy versus treatment as usual in a sample of trauma survivors who live under ongoing threat of violence in Rio de Janeiro, Brazil: study protocol for a randomised controlled trial

Fernanda Serpeloni, Jeanine Arabella Narrog, Simone Gonçalves de Assis, Joviana Quintes Avanci, Samuel Carleial, Anke Koebach

StayBalanced: implementation of evidence-based fall prevention balance training for older adults—cluster randomized controlled and hybrid type 3 trial

Alexandra Halvarsson, Kirsti Skavberg Roaldsen, Per Nilsen, Ing-Mari Dohrn, Agneta Ståhle

Watchful waiting as a strategy to reduce low-value spinal imaging: study protocol for a randomized trial

Joshua J. Fenton, Anthony Jerant, Peter Franks, Melissa Gosdin, Ilona Fridman, Camille Cipri, Gary Weinberg, Andrew Hudnut, Daniel J. Tancredi

MEDIASTinal staging of non-small cell lung cancer by endobronchial and endoscopic ultrasonography with or without additional surgical mediastinoscopy (MEDIASTrial): a statistical analysis plan

Jelle E. Bousema, Jouke T. Annema, Erik H. F. M. van der Heijden, Ad F. T. M. Verhagen, Marcel G. W. Dijkgraaf, Frank J. C. van den Broek, Nicole E. Papen-Botterhuis, Maggy Youssef-El Soud, Wim J. van Boven, Johannes M.A. Daniels, David J. Heineman, Harmen R. Zandbergen, Pepijn Brocken, Thirza Horn, Willem H. Steup, Jerry Braun, Rajen S. R. S. Ramai, Naomi Beck, Nicole P. Barlo, Martijn van Dorp, W. Hermien Schreurs, Anne-Marie C. Dingemans, Jos G. Maessen, Niels J. M. Claessens, Jan-Willem H. P. Lardenoije, Birgitta I. Hiddinga, Caroline van de Wauwer, Anthonie J. van der Wekken, Wessel E. Hanselaar, Robert Th J Kortekaas, Herman Rijna, Gerben P. Bootsma, Yvonne L. J. Vissers, Eelco J. Veen, Cor H. van der Leest, Emanuel Citgez, Eino B. van Duyn, Geertruid M. H. Marres, Eric R. van Thiel, Paul E. van Schil, Jan P. van Meerbeeck, Niels Smakman, Femke van der Meer, Mohammed D. Saboerali, Anne Marie Bosch, Wouter K. de Jong, Charles C. van Rossem, W. Johan Lie, Ewout A. Kouwenhoven, A. Jeske Staal- van den Brekel, Nike M. Hanneman, Roxane Heller-Baan, Valentin J. J. M. Noyez

iKanEat: protocol for a randomized controlled trial of megestrol as a component of a pediatric tube weaning protocol

Sarah Edwards, Paul E. Hyman, Hayat Mousa, Amanda Bruce, Jose Cocjin, Kelsey Dean, Kandace Fleming, Rebecca Swinburne Romine, Ann M. Davis

Effect of early treatment with polyvalent immunoglobulin on acute respiratory distress syndrome associated with SARS-CoV-2 infections (ICAR trial): study protocol for a randomized controlled trial

Aurélien Mazeraud, Bruno Gonçalves, Philippe Aegerter, Letizia Mancusi, Christine Rieu, Fernando Bozza, Khaoussou Sylla, Shidasp Siami, Tarek Sharshar

An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Noemi Anja Brog, Julia Katharina Hegy, Thomas Berger, Hansjörg Znoj

Effect of dexamethasone in patients with ARDS and COVID-19 – prospective, multi-centre, open-label, parallel-group, randomised controlled trial (REMED trial): A structured summary of a study protocol for a randomised 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, Helena Antoni, Petr Suk, Tomáš Korbička, Jan Hudec, Michal Fric, Václav Zvoníček, Tomáš Tencer, Martin Kolář, Petr Kafka, Michal Otáhal, Jan Rulíšek, Marek Flaksa, Eva Svobodová, Peter Sklienka, Filip Burša, Marcela Káňová, Jan Varady, Filip Haiduk, Vladimír Šrámek, Pavel Suk, Marek Fencl, Ivan Čundrle, Pavel Štětka, Marek Lukeš, Miloš Chobola, Jan Beroušek, Zuzana Přikrylová, Jiří Bureš, Jaromír Vajter, Vlasta Vlasáková, Michal Garaj, Lenka Doubravská, Jiří Pouska, Jakub Kletečka, Tomáš Graus, Tereza Šobáňová, Radovan Turek, Tomáš Tyll, Aleš Rára

UKCTOCS update: applying insights of delayed effects in cancer screening trials to the long-term follow-up mortality analysis

Matthew Burnell, Aleksandra Gentry-Maharaj, Steven J. Skates, Andy Ryan, Chloe Karpinskyj, Jatinderpal Kalsi, Sophia Apostolidou, Naveena Singh, Anne Dawnay, Robert Woolas, Lesley Fallowfield, Stuart Campbell, Alistair McGuire, Ian J. Jacobs, Mahesh Parmar, Usha Menon

Virtual reality stimulation to reduce the incidence of delirium in critically ill patients: study protocol for a randomized clinical trial

Aileen C. Naef, Marie-Madlen Jeitziner, Stephan M. Gerber, Béatrice Jenni-Moser, René M. Müri, Stephan M. Jakob, Tobias Nef, Matthias Hänggi

Effect of patient-controlled intravenous analgesia combined with flurbiprofen axetil and dezocine on postoperative analgesia for lobectomy (EPIC-FAD): a trial protocol

Jian Zhou, Qiang Pu, Lin Lin, Weelic Chong, Boran Chen, Yang Hai, Fei Liu, Lunxu Liu

Dropouts in randomized clinical trials of Korean medicine interventions: a systematic review and meta-analysis

Sae-rom Jeon, Dongwoo Nam, Tae-Hun Kim

Blended cognitive behaviour therapy for children and adolescents with mitochondrial disease targeting fatigue (PowerMe): study protocol for a multiple baseline single case experiment

I. L. Klein, K. F. E. van de Loo, T. J. Hoogeboom, M. C. H. Janssen, J. A. M. Smeitink, E. van der Veer, C. M. Verhaak, J. A. E. Custers

“Include me if you can”—reasons for low enrollment of pediatric patients in a psychopharmacological trial

Larissa Niemeyer, Konstantin Mechler, Jan Buitelaar, Sarah Durston, Bram Gooskens, Bob Oranje, Tobias Banaschewski, Ralf W. Dittmann, Alexander Häge

An integrated community and primary healthcare worker intervention to reduce stigma and improve management of common mental disorders in rural India: protocol for the SMART Mental Health programme

Mercian Daniel, Pallab K. Maulik, Sudha Kallakuri, Amanpreet Kaur, Siddhardha Devarapalli, Ankita Mukherjee, Amritendu Bhattacharya, Laurent Billot, Graham Thornicroft, Devarsetty Praveen, Usha Raman, Rajesh Sagar, Shashi Kant, Beverley Essue, Susmita Chatterjee, Shekhar Saxena, Anushka Patel, David Peiris

Community intervention for child tuberculosis active contact investigation and management: study protocol for a parallel cluster randomized controlled trial

Anca Vasiliu, Sabrina Eymard-Duvernay, Boris Tchounga, Daniel Atwine, Elisabete de Carvalho, Sayouba Ouedraogo, Michael Kakinda, Patrice Tchendjou, Stavia Turyahabwe, Albert Kuate Kuate, Georges Tiendrebeogo, Peter J. Dodd, Stephen M. Graham, Jennifer Cohn, Martina Casenghi, Maryline Bonnet

Eye Movement Desensitization (EMD) to reduce posttraumatic stress disorder-related stress reactivity in Indonesia PTSD patients: a study protocol for a randomized controlled trial

Eka Susanty, Marit Sijbrandij, Wilis Srisayekti, Anja C. Huizink

Retraction Note: Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial

Christoph Schnelle, Steffen Messerschmidt, Eunice J. Minford, Kate Greenaway-Twist, Maxine Szramka, Marianna Masiorski, Michelle Sheldrake, Mark Jones

Systematic review of available software for multi-arm multi-stage and platform clinical trial design

Elias Laurin Meyer, Peter Mesenbrink, Tobias Mielke, Tom Parke, Daniel Evans, Franz König

Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial

Jae-Hong Kim, Cham-Kyul Lee, Eun-Yong Lee, Myoung-Rae Cho, Young-Su Lee, Jeong-Soon Lee

Treating to target in psoriatic arthritis: assessing real-world outcomes and optimising therapeutic strategy for adults with psoriatic arthritis—study protocol for the MONITOR-PsA study, a trials within cohorts study design

Ines Rombach, William Tillett, Deepak Jadon, Laura Tucker, Marion Watson, Anne Francis, Yvonne Sinomati, Lucy Eldridge, Melina Dritsaki, Susan J. Dutton, Hussein Al-Mossawi, Nicola Gullick, Ben Thompson, Laura C. Coates

Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial

D. R. Singla, S. E. Meltzer-Brody, R. K. Silver, S. N. Vigod, J. J. Kim, L. M. La Porte, P. Ravitz, C. E. Schiller, N. Schoueri-Mychasiw, S. D. Hollon, A. Kiss, D. Clark, A. K. Dalfen, S. Dimidjian, B. N. Gaynes, S. R. Katz, A. Lawson, M. Leszcz, R. G. Maunder, B. H. Mulsant, K. E. Murphy, J. A. Naslund, M. L. Reyes-Rodríguez, A. M. Stuebe, C-L Dennis, V. Patel

Correction to: Direct antivirals working against the novel coronavirus: azithromycin (DAWn-AZITHRO), a randomized, multicenter, open-label, adaptive, proof-of-concept clinical trial of new antivirals working against SARS-CoV-2—azithromycin trial

Iwein Gyselinck, Laurens Liesenborghs, Ewout Landeloos, Ann Belmans, Geert Verbeke, Peter Verhamme, Robin Vos, W. Janssens

Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Zhuoran Kuang, Xiaoyan Li, Jianxiong Cai, Yaolong Chen, Xiaoyuan Qiu, Xiaojia Ni

Concept and development of an interactive tool for trial recruitment planning and management

Ruan Spies, Nandi Siegfried, Bronwyn Myers, Sara S. Grobbelaar

Using the half normal distribution to quantify covariate balance in cluster-randomized pragmatic trials

Jin Huang, David L. Roth

A Community-enabled Readiness for first 1000 Days Learning Ecosystem (CRADLE) for first-time families: study protocol of a three-arm randomised controlled trial

See Ling Loy, Thilagamangai, Joyce Teo, Sze Wern Chan, Nurul Khairani Abdul Razak, Oh. Moh Chay, Kee Chong Ng

Effects of salvianolate on microcirculatory disturbance in patients with stable coronary heart disease: study protocol for a randomized controlled trial

Zhanlu Li, Yi Luan, Min Wang, Ya Li, Xiaohua Shen, Guosheng Fu, Wenbin Zhang

Early antiviral treatment in outpatients with COVID-19 (FLARE): a structured summary of a study protocol for a randomised controlled trial

Li-An K. Brown, Nick Freemantle, Judy Breuer, Hakim-Moulay Dehbi, Kashfia Chowdhury, Gemma Jones, Felicia Ikeji, Amalia Ndoutoumou, Krishneya Santhirakumar, Nicky Longley, Anna M. Checkley, Joseph F. Standing, David M. Lowe

Evaluation of the effect of melatonin in patients with COVID-19-induced pneumonia admitted to the Intensive Care Unit: A structured summary of a study protocol for a randomized controlled trial

Ali Ameri, Masoomeh Frouz Asadi, Manoochehr Kamali, Majid Vatankhah, Ava Ziaei, Omid Safa, Masoomeh Mahmudi, Mohammad Fathalipour

Using electronic patient records to assess the effect of a complex antenatal intervention in a cluster randomised controlled trial—data management experience from the DESiGN Trial team

Sophie Relph, Maria Elstad, Bolaji Coker, Matias C. Vieira, Natalie Moitt, Walter Muruet Gutierrez, Asma Khalil, Jane Sandall, Andrew Copas, Deborah A. Lawlor, Dharmintra Pasupathy, Kirstie Coxon, Andrew Healey, Alessandro Alagna, Annette Briley, Mark Johnson, Christoph Lees, Neil Marlow, Lesley McCowan, Louise Page, Donald Peebles, Andrew Shennan, Basky Thilaganathan

Correction to: Development and evaluation of an interactive web-based decision-making programme on relapse management for people with multiple sclerosis (POWER@MS2)—study protocol for a randomised controlled trial

Anne Christin Rahn, Lisa Wenzel, Andrea Icks, Alexander Stahmann, Jutta Scheiderbauer, Kristina Grentzenberg, Markus Vomhof, Joseph Montalbo, Tim Friede, Christoph Heesen, Sascha Köpke

Importance of swift event adjudication of endpoints for adequate reporting to data and safety monitoring boards in clinical trials—lessons from CULPRIT-SHOCK

Peter Clemmensen, Benedikt Schrage, Uwe Zeymer, Holger Thiele, Karl Wegscheider

A study protocol for a randomized controlled trial of an anti-inflammatory nutritional intervention in patients with fibromyalgia

Ana Rita Silva, Alexandra Bernardo, Maria Fernanda de Mesquita, José Vaz Patto, Pedro Moreira, Maria Leonor Silva, Patrícia Padrão

Evaluation of the safety and efficacy of XAV-19 in patients with COVID-19-induced moderate pneumonia: study protocol for a randomized, double-blinded, placebo-controlled phase 2 (2a and 2b) trial

Benjamin Gaborit, Bernard Vanhove, Marie-Anne Vibet, Aurélie Le Thuaut, Karine Lacombe, Vincent Dubee, Florence Ader, Virginie Ferre, Eric Vicaut, Jéremie Orain, Morgane Le Bras, Anne Omnes, Laetitia Berly, Alexandra Jobert, Pascale Morineau-Le Houssine, Karine Botturi, Régis Josien, Laurent Flet, Nicolas Degauque, Sophie Brouard, Odile Duvaux, Alexandra Poinas, François Raffi, Eric Dailly, Thomas Guimard, Cécile Braudeau, Denis Malvy, Jean-François Faucher, Gabriela Illes Hajnal, Marc-Olivier Vareil, Mariam Roncato-Saberam, Laurent Vacher, Charlotte Biron, Maeva Lefebvre, Géraldine Gallot, Paul Le Turnier, Colin Deschanvres, Raphael Lecomte, Marie Chauveau, Anne-sophie Lecompte, Matthieu Grégoire, Ronan Bellouard, Guillaume Deslandes, Zineb Ouazene, Diane Bollens, Thibault Chiarabani, Jessica Krause-Le Garrec, Agathe Becker, Pierre Chauvelot, Anne Conrad, Tristan Ferry, Patrick Miailhes, Cécile Pouderoux, Sandrine Roux, Claire Triffault-Fillit

Integrating Behavioral Health and Primary Care (IBH-PC) to improve patient-centered outcomes in adults with multiple chronic medical and behavioral health conditions: study protocol for a pragmatic cluster-randomized control trial

Abigail M. Crocker, Rodger Kessler, Constance van Eeghen, Levi N. Bonnell, Ryan E. Breshears, Peter Callas, Jessica Clifton, William Elder, Chet Fox, Sylvie Frisbie, Juvena Hitt, Jennifer Jewiss, Roger Kathol, Kelly Clark/Keefe, Jennifer O’Rourke-Lavoie, George S. Leibowitz, C. R. Macchi, Mark McGovern, Brenda Mollis, Daniel J. Mullin, Zsolt Nagykaldi, Lisa Watts Natkin, Wilson Pace, Richard G. Pinckney, Douglas Pomeroy, Alexander Pond, Rachel Postupack, Paula Reynolds, Gail L. Rose, Sarah Hudson Scholle, William J. Sieber, Terry Stancin, Kurt C. Stange, Kari A. Stephens, Kathryn Teng, Elizabeth Needham Waddell, Benjamin Littenberg

Feasibility and efficacy of a decision aid for emergency department patients with suspected ureterolithiasis: protocol for an adaptive randomized controlled trial

Elizabeth M. Schoenfeld, Kye E. Poronsky, Lauren M. Westafer, Brianna M. DiFronzo, Paul Visintainer, Charles D. Scales, Erik P. Hess, Peter K. Lindenauer

Coagulopathy of hospitalised COVID-19: A Pragmatic Randomised Controlled Trial of Therapeutic Anticoagulation versus Standard Care as a Rapid Response to the COVID-19 Pandemic (RAPID COVID COAG – RAPID Trial): A structured summary of a study protocol for a randomised controlled trial

Michelle Sholzberg, Grace H. Tang, Elnara Negri, Hassan Rahhal, Lisa Baumann Kreuziger, Carlos E. Pompilio, Paula James, Michael Fralick, Musaad AlHamzah, Faris Alomran, Eric Tseng, Gloria Lim, David Lillicrap, Marc Carrier, Fionnuala Ní Áinle, Andrew Beckett, Bruno R. da Costa, Kevin Thorpe, Saskia Middeldorp, Agnes Lee, Mary Cushman, Peter Jüni

Statistical consideration when adding new arms to ongoing clinical trials: the potentials and the caveats

Kim May Lee, Louise C. Brown, Thomas Jaki, Nigel Stallard, James Wason

Study factors associated with the incompletion of clinical trials that include pediatric patients: a retrospective analysis of the European Clinical Trials Database and a lesson from the European region

Nanae Tanemura, Tsuyoshi Sasaki, Junko Sato, Hisashi Urushihara

Clinical research and burnout syndrome in Italy – only a physicians’ affair?

Celeste Cagnazzo, Roberto Filippi, Giulia Zucchetti, Rosita Cenna, Cristiana Taverniti, Agata Sue Ellen Guarrera, Stefano Stabile, Irene Federici, Manuela Monti, Sara Pirondi, Sara Testoni, Franca Fagioli

A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences

Samina Ali, Gareth Hopkin, Naveen Poonai, Lawrence Richer, Maryna Yaskina, Anna Heath, Terry Paul Klassen, Chris McCabe, Amy Drendel, Gareth Hopkin, Jeff Round, Martin Offringa, Petros Pechlivanoglou, Eleanor Pullenayegum, David Rios, Marie-Christine Auclair, Kelly Kim, Lise Bourrier, Lauren Dawson, Kamary Coriolano DaSilva, Pamela Marples, Rick Watts, Jennifer Thull-Freedman, Patrick McGrath, Timothy A. D. Graham, Lisa Hartling, Tannis Erickson, Brendon Foot, Kurt Schreiner, Julie Leung, Martin Offringa, Petros Pechlivanoglou, Eleanor Pullenayegum, Juan David Rios, Jeff Round

The effect of opioid-free anesthesia on the quality of recovery after gynecological laparoscopy: study protocol for a prospective randomized controlled trial

Jae Yen Song, Hoon Choi, Minsuk Chae, Jemin Ko, Young Eun Moon

Determination of the optimal dose of ephedrine in the treatment of arterial hypotension due to general anesthesia in neonates and infants below 6 months old: the ephedrine study protocol for a randomized, open-label, controlled, dose escalation trial

A. S. Szostek, P. Boucher, F. Subtil, O. Zerzaihi, C. Saunier, M. de Queiroz Siqueira, F. Merquiol, P. Martin, M. Granier, A. Gerst, A. Lambert, T. Storme, D. Chassard, P. Nony, B. Kassai, S. Gaillard

COVIDENZA - A prospective, multicenter, randomized PHASE II clinical trial of enzalutamide treatment to decrease the morbidity in patients with Corona virus disease 2019 (COVID-19): a structured summary of a study protocol for a randomised controlled trial

Karin Welén, Anna K Överby, Clas Ahlm, Eva Freyhult, David Robinsson, Anna Jonsson Henningsson, Johan Stranne, Daniel Bremell, Martin Angelin, Elisabeth Lindquist, Robert Buckland, Camilla Thellenberg Carlsson, Karlis Pauksens, Anna Bill-Axelsson, Olof Akre, Cecilia Ryden, Magnus Wagenius, Anders Bjartell, Anna C. Nilsson, Johan Styrke, Johanna Repo, Åse Östholm Balkhed, Katarina Niward, Magnus Gisslén, Andreas Josefsson

Energy and protein intake in medical and geriatric inpatients with MEDPass versus conventional administration of oral nutritional supplements: study protocol for the randomized controlled MEDPass Trial

Silvia Kurmann, Emilie Reber, Maria F. Vasiloglou, Philipp Schuetz, Andreas W. Schoenenberger, Katja Uhlmann, Anna-Barbara Sterchi, Zeno Stanga

Patient experiences of receiving arthroscopic surgery or personalised hip therapy for femoroacetabular impingement in the context of the UK fashion study: a qualitative study

A. X. Realpe, N. E. Foster, E. J. Dickenson, M. Jepson, D. R. Griffin, J. L. Donovan, Rachel Hobson, Peter Wall, Stavros Petrou, Nick Parsons, Matthew Costa

Napping on the night shift and its impact on blood pressure and heart rate variability among emergency medical services workers: study protocol for a randomized crossover trial

P. Daniel Patterson, Leonard S. Weiss, Matthew D. Weaver, David D. Salcido, Samantha E. Opitz, Tiffany S. Okerman, Tanner T. Smida, Sarah E. Martin, Francis X. Guyette, Christian Martin-Gill, Clifton W. Callaway

Effectiveness of low-dose theophylline for the management of biomass-associated COPD (LODOT-BCOPD): study protocol for a randomized controlled trial

Trishul Siddharthan, Suzanne L. Pollard, Peter Jackson, Nicole M. Robertson, Adaeze C. Wosu, Nihaal Rahman, Roma Padalkar, Isaac Sekitoleko, Esther Namazzi, Patricia Alupo, John R. Hurst, Robert Kalyesubula, David Dowdy, Robert Wise, Peter J. Barnes, William Checkley, Bruce Kirenga

Combination of first-line chemotherapy with Kanglaite injections versus first-line chemotherapy alone for advanced non-small-cell lung cancer: study protocol for an investigator-initiated, multicenter, open-label, randomized controlled trial

Ruike Gao, Ying Zhang, Wei Hou, Jie Li, Guanghui Zhu, Xiaoxiao Zhang, Bowen Xu, Zhe Wu, Heping Wang

Effect of ‘hand and foot acupuncture with twelve needles’ on hemiplegia patients with ‘qi deficiency and blood stasis’ syndrome in the convalescent stage of Ischaemic stroke: study protocol for a randomised controlled trial

Wei-Hao Fang, Gui-Ling Wang, Qiang Liu, Xiao Ding, Zhen-Yao Wang, Xin-Wei Wang, Xiao-Wei Yang, Yang Yang, Da-Wei Zhang, Qing Wei, Hu Zhang

Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Yan-ning Ma, Cheng-liang Zhong, Si-yuan Hu, Qiu-han Cai, Sheng-xuan Guo

Reshaping the path of vascular cognitive impairment with resistance training: a study protocol for a randomized controlled trial

Teresa Liu-Ambrose, Elizabeth Dao, Rachel A. Crockett, Cindy K. Barha, Ryan S. Falck, John R. Best, Ging-Yeuk R. Hsiung, Thalia S. Field, Kenneth M. Madden, Walid A. Alkeridy, Narlon C. Boa Sorte Silva, Jennifer C. Davis, Lisanne F. ten Brinke, Stephanie Doherty, Roger C. Tam

Timing of antiretroviral therapy for HIV-infected patients with cytomegalovirus retinitis: study protocol of a multi-center prospective randomized controlled trial

Xiao-Qing He, Yin-Qiu Huang, Yan-Ming Zeng, Yuan-Yuan Qin, Sheng-Quan Tang, Xiao-Lei Xu, Vijay Harypursat, Yan-Qiu Lu, Min Liu, Jing Yuan, Yao-Kai Chen

Recruitment patterns in a large international randomized controlled trial of perioperative care in cancer patients

Aaron Gazendam, Anthony Bozzo, Patricia Schneider, Victoria Giglio, David Wilson, Michelle Ghert

Systematic review of outcome domains and instruments used in designs of clinical trials for interventions that seek to restore bilateral and binaural hearing in adults with unilateral severe to profound sensorineural hearing loss (‘single-sided deafness’)

Roulla Katiri, Deborah A. Hall, Catherine F. Killan, Sandra Smith, Pattarawadee Prayuenyong, Pádraig T. Kitterick

Passive Immunity Trial for Our Nation (PassITON): study protocol for a randomized placebo-control clinical trial evaluating COVID-19 convalescent plasma in hospitalized adults

Wesley H. Self, Thomas G. Stewart, Allison P. Wheeler, Wissam El Atrouni, Amanda J. Bistran-Hall, Jonathan D. Casey, Vince D. Cataldo, James D. Chappell, Claudia S. Cohn, Jessica B. Collins, Mark R. Denison, Marjolein de Wit, Sheri L. Dixon, Abhijit Duggal, Terri L. Edwards, Magali J. Fontaine, Adit A. Ginde, Michelle S. Harkins, Thelma Harrington, Estelle S. Harris, Daanish Hoda, Tina S. Ipe, Stuti J. Jaiswal, Nicholas J. Johnson, Alan E. Jones, Maryrose Laguio-Vila, Christopher J. Lindsell, Jason Mallada, Manoj J. Mammen, Ryan A. Metcalf, Elizabeth A. Middleton, Simon Mucha, Hollis R. O’Neal Jr, Sonal R. Pannu, Jill M. Pulley, Xian Qiao, Jay S. Raval, Jillian P. Rhoads, Harry Schrager, Carl Shanholtz, Nathan I. Shapiro, Stephen J. Schrantz, Isaac Thomsen, Krista K. Vermillion, Gordon R. Bernard, Todd W. Rice

Action observation treatment-based exoskeleton (AOT-EXO) for upper extremity after stroke: study protocol for a randomized controlled trial

Zejian Chen, Nan Xia, Chang He, Minghui Gu, Jiang Xu, Xiaohua Han, Xiaolin Huang

Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY): a multi-center randomized controlled study comparing alternative antibiotic regimens in patients undergoing tumor resections with endoprosthetic replacements—a statistical analysis plan

Patricia Schneider, Diane Heels-Ansdell, Lehana Thabane, Michelle Ghert, Michelle Ghert, Mohit Bhandari, Benjamin Deheshi, Gordon Guyatt, Ginger Holt, Timothy O’Shea, R. Lor Randall, Lehana Thabane, Roberto Vélez, Jay Wunder, Patricia Schneider, Victoria Giglio, Paula McKay, Sheila Sprague, Diane Heels-Ansdell, Lisa Buckingham, Peter Rose, Brian Brigman, Eleanor Pullenayegum, Robert Turcotte, David Wilson, Peter Ferguson, Krista Goulding, Joel Werier, Hesham Abdelbary, Paul Clarkson, Marc Isler, Sophie Mottard, Norbert Dion, Annie Arteau, Jennifer Halpern, Herbert Schwartz, Megan Anderson, Mark Gebhardt, Kevin Jones, John Healey, Marcos Galli Serra, Mark Clayer, Adam Lindsay, Tessa Balach, John Abraham, Scot Brown, Benjamin Miller, Edward Cheng, Thomas Scharschmidt, Joel Mayerson, Nickolas Reimer, David Geller, Bang Hoang, Raffi Avedian, Shannon Puloski, Michael Monument, Albert Aboulafia, Timothy Damron, Howard Goodman, Kurt Weiss, Mark Goodman, Joseph Schwab, Matthew DiCaprio, Bradford Palmer, Yee-Cheen Duong, Kenneth Gundle, James Hayden, Carol Morris, Adam Levin, Reitze Rodseth, Leonard Marais, André Mathias Baptista, Juan Pablo Zummaraga, Rosanna Wustrack, Richard O’Donnell, Joel Sorger, Daniel Lerman, André Spiguel, C. Parker Gibbs, Mark Scarborough, Sander Dijkstra, Michiel van de Sande, Shah Alam Khan, Venkatesan Sampath Kumar, John Neilson, Eric Henderson, David Greenberg, Paul Jutte, Nathan Mesko, Lukas Nystrom, Ahmed Elghoneimy, Ricardo Becker, Richard Nicholas, Nicholas Bernthal, Jeffrey Eckhardt, Francis Hornicek, Andreas Leithner, Marko Bergovec, Mann Hong Tan, Suraya Zainul Abidin, Steven Thorpe

Post-exposure prophylaxis against SARS-CoV-2 in close contacts of confirmed COVID-19 cases (CORIPREV): study protocol for a cluster-randomized trial

Darrell H. S. Tan, Adrienne K. Chan, Peter Jüni, George Tomlinson, Nick Daneman, Sharon Walmsley, Matthew Muller, Rob Fowler, Srinivas Murthy, Natasha Press, Curtis Cooper, Todd Lee, Tony Mazzulli, Allison McGeer

Correction to: IMMPACT-recommended outcome measures and tools of assessment in burning mouth syndrome RCTs: an international Delphi survey protocol

Barbara Carey, Arwa M. Farag, Cibele Nasri-Heir, Gary D. Klasser, Anura Ariyawardana, Milda Chmieliauskaite, Andrea Sardella, Charles R. Carlson, Craig S. Miller, Lina Mejia, Francis E. O’Neill, Ruy Albuquerque

A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial

Pedro Fonseca Zuccolo, Mariana O. Xavier, Alicia Matijasevich, Guilherme Polanczyk, Daniel Fatori

Per-protocol analysis of the ZINC trial for HIV disease among alcohol users

Sara Lodi, Matthew Freiberg, Natalia Gnatienko, Elena Blokhina, Tatiana Yaroslavtseva, Evgeny Krupitsky, Eleanor Murray, Jeffrey H. Samet, Debbie M. Cheng

Role of the active cycle of breathing technique combined with phonophoresis for the treatment of patients with chronic obstructive pulmonary disease (COPD): study protocol for a preliminary randomized controlled trial

M. D. Shen, L. R. Guo, Y. W. Li, R. T. Gao, X. Sui, Z. Du, L. Q. Xu, H. Y. Shi, Y. Y. Ni, X. Zhang, Y. Pang, W. Zhang, T. Z. Yu, F. Li

The time is now: role of pragmatic clinical trials in guiding response to global pandemics

Aws Almufleh, Jacob Joseph

Hematologists’ barriers and enablers to screening and recruiting patients to a chimeric antigen receptor (CAR) T cell therapy trial: a theory-informed interview study

Gisell Castillo, Manoj Lalu, Sarah Asad, Madison Foster, Natasha Kekre, Dean Fergusson, Terry Hawrysh, Harold Atkins, Kednapa Thavorn, Joshua Montroy, Stuart Schwartz, Robert Holt, Raewyn Broady, Justin Presseau

Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: a double-blind, randomized, placebo-controlled trial

Hadi Bazyar, Ahmad Zare Javid, Hossein Bavi Behbahani, Fardin Moradi, Bahman Moradi Poode, Parichehr Amiri

Understanding implementability in clinical trials: a pragmatic review and concept map

Miranda S. Cumpston, Steven A. Webb, Philippa Middleton, Greg Sharplin, Sally Green, Karen Best, Frank Bloomfield, Alan Cass, Paul Cohen, Sue Crengle, Louise Cullen, Dashiell Gantner, Heide Gaulke, Davina Ghersi, Sally Green, Paul Glasziou, Tiffany Harris-Brown, Stephen Jan, David Johnson, Samantha Keogh, Chris Levi, Philippa Middleton, Sandra Peake, Angela Scheppokat, Paul Scuffham, Greg Sharplin, Tim Shaw, David Story, Helena Teede, Val Theisz, Judith Trotman, Steve Webb, Carolina Weller, Anne Woollett, Sophia Zoungas

Sjogren’s syndrome in clinical trials of traditional Chinese medicine: protocol for the development of a core outcome set

Ming Liu, Ya Gao, Yuan Yuan, Shuzhen Shi, Kelu Yang, Jiyuan Shi, Jiarui Wu, Junhua Zhang, Jinhui Tian

COVID-19: underpowered randomised trials, or no randomised trials?

Atle Fretheim

Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare trial): study protocol for a stepped-wedge cluster randomised controlled trial

Carina King, Malini Pires, Naveed Ahmed, Kohenour Akter, Abdul Kuddus, Andrew Copas, Hassan Haghparast-Bidgoli, Joanna Morrison, Tasmin Nahar, Sanjit Kumer Shaha, A. K. Azad Khan, Kishwar Azad, Edward Fottrell

Peritoneal flap for lymphocele prophylaxis following robotic-assisted laparoscopic radical prostatectomy with pelvic lymph node dissection: study protocol and trial update for the randomized controlled PELYCAN study

M. Neuberger, K. F. Kowalewski, V. Simon, F. Wessels, F. Siegel, T. S. Worst, N. Westhoff, J. von Hardenberg, M. Kriegmair, M. S. Michel, P. Honeck, P. Nuhn

Assessment of remifentanil for rapid sequence induction and intubation in patients at risk of pulmonary aspiration of gastric contents compared to rapid-onset paralytic agents: study protocol for a non-inferiority simple blind randomized controlled trial (the REMICRUSH study)

Nicolas Grillot, Matthias Garot, Sigismond Lasocki, Olivier Huet, Pierre Bouzat, Charlène Le Moal, Mathieu Oudot, Nolwenn Chatel-Josse, Younes El Amine, Marc Danguy des Déserts, Nathalie Bruneau, Raphael Cinotti, Jean-Stéphane David, Olivier Langeron, Vincent Minville, Martine Tching-Sin, Elodie Faurel-Paul, Céline Lerebourg, Delphine Flattres-Duchaussoy, Alexandra Jobert, Karim Asehnoune, Fanny Feuillet, Antoine Roquilly

Design and implementation of botulinum toxin on cricopharyngeal dysfunction guided by a combination of catheter balloon, ultrasound, and electromyography (BECURE) in patients with stroke: study protocol for a randomized, double-blinded, placebo-controlled trial

Mengshu Xie, Zulin Dou, Guifang Wan, Peishan Zeng, Hongmei Wen

Clinical study on the effect of multifocal contact lenses on myopia progression in myopia school children

Osamu Hieda, Yo Nakamura, Takahiro Hiraoka, Miho Kojima, Tetsuro Oshika, Chie Sotozono

A clinical and cost-effectiveness trial of a parent group intervention to manage challenging restricted and repetitive behaviours in young children with autism spectrum disorder: study protocol for a randomised controlled trial

Victoria Grahame, Linda Dixon, Sue Fletcher-Watson, Deborah Garland, Magdalena Glod, Jane Goodwin, Zoe Grayson, Saoirse Heron, Emma Honey, Rebecca Iversen, Adetayo S. Kasim, Ashleigh Kernohan, Ehsan Kharatikoopaei, Ann Le Couteur, Leila Mackie, Ayesha Mathias, Helen Probert, Deborah Riby, Priyanka Rob, Leanne Rogan, Sarah Thompson, Luke Vale, Eamonn Walls, Elspeth Imogen Webb, Christopher Weetman, Faye Wolstenhulme, Ruth Wood, Jacqui Rodgers

What are the challenges when recruiting to a trial in children’s social care? A qualitative evaluation of a trial of foster carer training

Gwenllian Moody, Lucy Brookes-Howell, Rebecca Cannings-John, Sue Channon, Elinor Coulman, Alyson Rees, Jeremy Segrott, Michael Robling

Evaluating the efficacy of a multistrain probiotic supplementation for prevention of neonatal sepsis in 0–2-month-old low birth weight infants in India—the “ProSPoNS” Study protocol for a phase III, multicentric, randomized, double-blind, placebo-controlled trial

Anju Pradhan Sinha, Subodh S. Gupta, Ramesh Poluru, Abhishek V. Raut, Narendra Kumar Arora, Ravindra Mohan Pandey, Aditya Ranjan Sahu, Adhisivam Bethou, Sunil Sazawal, Sailajanandan Parida, Ashish Bavdekar, Arvind Saili, Rajni Gaind, Arti Kapil, Bishan S. Garg, Chetna Maliye, Manish Jain, Kamlesh S. Mahajan, Pratibha Dhingra, Keshab C. Pradhan, Anand S. Kawade, Sushma Nangia, Ajit Mukherjee, Reeta Rasaily, Radhey Shyam Sharma, Pankaj Gupta, Amritanshu Kumar, Sukanya Sarma, Apoorva Mathur, Dixit Prajapati, Kanchan Yadav, Neeraj Kumar Kashyap

Family Talk versus usual services in improving child and family psychosocial functioning in families with parental mental illness (PRIMERA—Promoting Research and Innovation in Mental hEalth seRvices for fAmilies and children): study protocol for a randomised controlled trial

Mairead Furlong, Sinead McGilloway, Christine Mulligan, Colm McGuinness, Nuala Whelan

The effects of different doses of exercise on pancreatic β-cell function in patients with newly diagnosed type 2 diabetes: study protocol for and rationale behind the “DOSE-EX” multi-arm parallel-group randomised clinical trial

Mark P. P. Lyngbaek, Grit E. Legaard, Sebastian L. Bennetsen, Camilla S. Feineis, Villads Rasmussen, Nana Moegelberg, Cecilie F. Brinkløv, Anette B. Nielsen, Katja S. Kofoed, Carsten A. Lauridsen, Caroline Ewertsen, Henrik E. Poulsen, Robin Christensen, Gerrit Van Hall, Kristian Karstoft, Thomas P. J. Solomon, Helga Ellingsgaard, Thomas P. Almdal, Bente K. Pedersen, Mathias Ried-Larsen

Clinical efficacy of transcutaneous tibial nerve stimulation (TTNS) versus sham therapy (part I) and TTNS versus percutaneous tibial nerve stimulation (PTNS) (part II) on the short term in children with the idiopathic overactive bladder syndrome: protocol for part I of the twofold double-blinded randomized controlled TaPaS trial

Lynn Ghijselings, Catherine Renson, Johan Van de Walle, Karel Everaert, Anne-Françoise Spinoit

Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study

John P. Haran, Jose C. Pinero, Yan Zheng, Norma Alonzo Palma, Mark Wingertzahn

Effects of pomegranate juice (Punica Granatum) on inflammatory biomarkers and complete blood count in patients with COVID-19: a structured summary of a study protocol for a randomized clinical trial

Mojtaba Yousefi, Mohammadreza Sadriirani, Azizollah PourMahmoudi, Sara Mahmoodi, Bahar Samimi, Mahboobe Hosseinikia, Zaker Saeedinezhad, Seyed Bahman Panahande

Phase-IIa randomized, double-blind, sham-controlled, parallel group trial on anodal transcranial direct current stimulation (tDCS) over the left and right tempo-parietal junction in autism spectrum disorder—StimAT: study protocol for a clinical trial

Christina Luckhardt, Magdalena Schütz, Andreas Mühlherr, Hannah Mössinger, Sara Boxhoorn, Astrid Dempfle, Ricardo Salvador, Giulio Ruffini, Helena C. Pereira, Miguel Castelo-Branco, Marianne Latinus, Frédérique Bonnet-Brilhault, Julia Siemann, Michael Siniatchkin, Christine Ecker, Christine M. Freitag

Ultrasound-guided erector spinae plane block versus thoracic paravertebral block on postoperative analgesia after laparoscopic nephroureterectomy: study protocol of a randomized, double-blinded, non-inferiority design trial

Zhen-Zhen Xu, Xue Li, Zhen Zhang, Zheng-Ye Liu, Lin-Lin Song, Xue-Ying Li, Hong Zhang

Effect of the combination of automated peripheral mechanical stimulation and physical exercise on aerobic functional capacity and cardiac autonomic control in patients with Parkinson’s disease: a randomized clinical trial protocol

Nicolle Zelada-Astudillo, Vinicius Christianini Moreno, Andrea Herrera-Santelices, Fabio Augusto Barbieri, Antonio Roberto Zamunér

How ‘place’ matters for addressing the HIV epidemic: evidence from the HPTN 071 (PopART) cluster-randomised controlled trial in Zambia and South Africa

Virginia Bond, Graeme Hoddinott, Lario Viljoen, Fredrick Ngwenya, Melvin Simuyaba, Bwalya Chiti, Rhoda Ndubani, Nozizwe Makola, Deborah Donnell, Ab Schaap, Sian Floyd, James Hargreaves, Kwame Shanaube, Sarah Fidler, Peter Bock, Helen Ayles, Richard Hayes, Musonda Simwinga, Janet Seeley

Developing a complex intervention whilst considering implementation: the TANDEM (Tailored intervention for ANxiety and DEpression Management) intervention for patients with chronic obstructive pulmonary disease (COPD)

Liz Steed, Karen Heslop-Marshall, Ratna Sohanpal, Sarah Saqi-Waseem, Moira Kelly, Hilary Pinnock, Stephanie Taylor

Acupuncture for the treatment of diarrheal-predominant irritable bowel syndrome: study protocol for a pilot randomized controlled trial

Ling-Yu Qi, Yu Wang, Li-Qiong Wang, Yan-Fen She, Guang-Xia Shi, Ying Li, Li-Li Chi, Bang-Qi Wu, Jian-Feng Tu, Ying Lin, Fang-Ting Yu, Jing-Wen Yang, Cun-Zhi Liu

Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial

Jesus Montero-Marin, Elizabeth Nuthall, Sarah Byford, Catherine Crane, Tim Dalgleish, Tamsin Ford, Poushali Ganguli, Mark T. Greenberg, Obioha C. Ukoumunne, Russell M. Viner, J. Mark G. Williams, Saz Ahmed, Matthew Allwood, Louise Auckland, Ruth Baer, Susan Ball, Marc Bennett, Sarah-Jayne Blakemore, Daniel Brett, Triona Casey, Katherine De Wilde, Darren Dunning, Eleanor-Rose Farley, Katie Fletcher, Lucy Foulkes, Cait Griffin, Kirsty Griffiths, Nils Kapplemann, Rachel Knight, Suzannah Laws, Jovita Leung, Liz Lord, Emma Medlicott, Lucy Palmer, Jenna Parker, Ariane Petit, Blanca Piera Pi-Sunyer, Isobel Pryor-Nitsch, Lucy Radley, Anam Raja, Ashok Sakhardande, Jeremy Shackleford, Anna Sonley, Laura Taylor, Maris Vainre, Lucy Warriner, Brian Wainman, Willem Kuyken

Effect of a prebiotic supplement on knee joint function, gut microbiota, and inflammation in adults with co-morbid obesity and knee osteoarthritis: study protocol for a randomized controlled trial

Rafael Fortuna, David A. Hart, Keith A. Sharkey, Rachel A. Schachar, Kelly Johnston, Raylene A. Reimer

Protocol for a randomized controlled trial of pre-pregnancy lifestyle intervention to reduce recurrence of gestational diabetes: Gestational Diabetes Prevention/Prevención de la Diabetes Gestacional

Suzanne Phelan, Elissa Jelalian, Donald Coustan, Aaron B. Caughey, Kristin Castorino, Todd Hagobian, Karen Muñoz-Christian, Andrew Schaffner, Laurence Shields, Casey Heaney, Angelica McHugh, Rena R. Wing

The use of virtual reality to reduce stress among night-shift anesthesiologists: study protocol for a crossover trial

Chaojin Chen, Liubing Chen, Ning Shen, Chenfang Luo, Ren Wang, Hongyi Fang, Qi Zhang, Ziqing Hei

Impact and cost-effectiveness evaluation of a community-based rehabilitation intervention on quality of life among Chinese adults with hearing loss: study protocol for a randomized controlled trial

Xin Ye, Dawei Zhu, Siyuan Chen, Xuefeng Shi, Rui Gong, Juncheng Wang, Huibin Zuo, Mei Zhang, Ping He

Correction to: Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Zhuoran Kuang, Xiaoyan Li, Jianxiong Cai, Yaolong Chen, Xiaoyuan Qiu, Xiaojia Ni

The COVID-19 pandemic and new clinical trial activations

Joseph M. Unger, Hong Xiao

FASTER and SCOTT&EVA trainings for adults with high-functioning autism spectrum disorder (ASD): study protocol for a randomized controlled trial

Ludger Tebartz van Elst, Thomas Fangmeier, Ulrich Max Schaller, Oliver Hennig, Meinhard Kieser, Katja Koelkebeck, Charlotte Kuepper, Veit Roessner, Dirk Wildgruber, Isabel Dziobek

Randomized clinical trial to compare the efficacy of ivermectin versus placebo to negativize nasopharyngeal PCR in patients with early COVID-19 in Peru (SAINT-Peru): a structured summary of a study protocol for randomized controlled trial

Patricia J. Garcia, Hansel Mundaca, Cesar Ugarte-Gil, Patricia Leon, German Malaga, Carlos Chaccour, Cesar P. Carcamo

Primary Care implementation of Germ Defence, a digital behaviour change intervention to improve household infection control during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial

Jeremy Horwood, Melanie Chalder, Ben Ainsworth, James Denison-Day, Frank de Vocht, Martha M. C. Elwenspoek, Pippa Craggs, Rachel Denholm, Jonathan Sterne, Cathy Rice, Sascha Miller, Beth Stuart, Paul Little, Michael Moore, Merlin Willcox, John Macleod, Martin Gullford, Kate Morton, Lauren Towler, Nick Francis, Richard Amlôt, Lucy Yardley

Evaluation of the online-based self-help programme “Selfapy” in patients with unipolar depression: study protocol for a randomized, blinded parallel group dismantling study

Rico Krämer, Stephan Köhler

Effectiveness of Yijinjing on cognitive functions in post-stroke patients with mild cognitive impairment: study protocol for a randomized controlled trial

Xin Xue, Xue-Ming Jin, Kai-Liang Luo, Xin-Hao Liu, Li Zhang, Jun Hu

Comparison of single-injection ultrasound-guided thoracic paravertebral block with transversus abdominis plane block in peritoneal dialysis catheter implantation: a randomized controlled trial

Xiao-juan Jiang, Zi Li, Qi Li, Hai-yan Zhang, Xiao-hong Tang, Tao Zhu

Supporting Parents & Kids Through Lockdown Experiences (SPARKLE): A digital parenting support app implemented in an ongoing general population cohort study during the COVID-19 pandemic: A structured summary of a study protocol for a randomised controlled trial

Katarzyna Kostyrka-Allchorne, Cathy Creswell, Sarah Byford, Crispin Day, Kimberley Goldsmith, Marta Koch, Walter Muruet Gutierrez, Melanie Palmer, Jasmine Raw, Olly Robertson, James Shearer, Adrienne Shum, Petr Slovak, Polly Waite, Edmund J. S. Sonuga-Barke

Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial

Ana Cristina Carvalho, Jorge Moreira, Pedro Cubelo, Pedro Cantista, Catarina Aguiar Branco, Bruno Guimarães

Yoga for older adults with multimorbidity (the Gentle Years Yoga Trial): study protocol for a randomised controlled trial

Garry A. Tew, Laura Bissell, Belen Corbacho, Caroline Fairhurst, Jenny Howsam, Jess Hugill-Jones, Camila Maturana, Shirley-Anne S. Paul, Tim Rapley, Jenny Roche, Fi Rose, David J. Torgerson, Lesley Ward, Laura Wiley, David Yates, Catherine Hewitt

Multi-arm Trial of Inflammatory Signal Inhibitors (MATIS) for hospitalised patients with mild or moderate COVID-19 pneumonia: a structured summary of a study protocol for a randomised controlled trial

Nikhil Vergis, Rachel Phillips, Victoria Cornelius, Alexia Katsarou, Taryn Youngstein, Lucy Cook, Michelle Willicombe, Clio Pilay, Tina Shturova, Melanie Almonte, Asad Charania, Richard Turner, Onn Min Kon, Graham Cooke, Mark Thursz, Svetlana Cherlin, James Wason, Dragana Milojkovic, Andew J. Innes, Nichola Cooper

The efficacy of N-Acetylcysteine in severe COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial

Arash Rahimi, Hamid Reza Samimagham, Mehdi Hassani Azad, Dariush Hooshyar, Mohsen Arabi, Mitra KazemiJahromi

The Early Youth Engagement in first episode psychosis (EYE-2) study: pragmatic cluster randomised controlled trial of implementation, effectiveness and cost-effectiveness of a team-based motivational engagement intervention to improve engagement

Kathryn Greenwood, Rebecca Webb, Jenny Gu, David Fowler, Richard de Visser, Stephen Bremner, Iga Abramowicz, Nicky Perry, Stuart Clark, Anastacia O’Donnell, Dan Charlton, Rebecca Jarvis, Philippa Garety, Sunil Nandha, Belinda Lennox, Louise Johns, Shanaya Rathod, Peter Phiri, Paul French, Heather Law, Jo Hodgekins, Michelle Painter, Cate Treise, James Plaistow, Francis Irwin, Rose Thompson, Tanya Mackay, Carl R. May, Andy Healey, Richard Hooper, Emmanuelle Peters

Prophylactic use of dural tenting sutures in elective craniotomies in adults—is it necessary? A study protocol for a multicentre, investigator- and participant-blinded randomised, parallel-group, non-inferiority trial

Przemysław Kunert, Łukasz Przepiórka, Jan Fortuniak, Karol Wiśniewski, Ernest Jan Bobeff, Patrycja Larysz, Rafał Kruk, Bartłomiej Kulesza, Dariusz Szczepanek, Piotr Ładziński, Jarosław Żyłkowski, Sławomir Kujawski, Kamila Łabędzka, Dariusz Jaskólski, Radosław Rola, Tomasz Trojanowski, Andrzej Marchel

Adding a smartphone app to global postural re-education to improve neck pain, posture, quality of life, and endurance in people with nonspecific neck pain: a randomized controlled trial

Fatemeh Abadiyan, Malihe Hadadnezhad, Zohre Khosrokiani, Amir Letafatkar, Haniyeh Akhshik

Improving cognition in severe mental illness by combining cognitive remediation and transcranial direct current stimulation: study protocol for a pragmatic randomized controlled pilot trial (HEADDSET)

Anika Poppe, Leonie Bais, Daniëlle van Duin, Branislava Ćurčić-Blake, Gerdina Hendrika Maria Pijnenborg, Lisette van der Meer

A randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the efficacy and safety of SARS-CoV-2 vaccine (inactivated, Vero cell): a structured summary of a study protocol for a randomised controlled trial

Murat Akova, Serhat Unal

Impact of a shared decision-making mHealth tool on caregivers’ team situational awareness, communication effectiveness, and performance during pediatric cardiopulmonary resuscitation: study protocol of a cluster randomized controlled trial

Frédéric Ehrler, Cyril Sahyoun, Sergio Manzano, Oliver Sanchez, Alain Gervaix, Christian Lovis, Delphine S. Courvoisier, Laurence Lacroix, Johan N. Siebert

Conducting clinical trials during the COVID-19 pandemic—a collaborative trial network response

Laura Robison, Yeoungjee Cho, Andrea K. Viecelli, David W. Johnson, Carmel M. Hawley, Andrea Valks, Peta-Anne Paul-Brent, Ruth Stastny, Julie Varghese, Charani Kiriwandeniya, Elaine M. Pascoe, Liza A. Vergara, Magid A. Fahim, Neil Boudville, Rathika Krishnasamy, Donna Reidlinger

Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic

Sharon B. Love, Emma Armstrong, Carrie Bayliss, Melanie Boulter, Lisa Fox, Joanne Grumett, Patricia Rafferty, Barbara Temesi, Krista Wills, Andrea Corkhill

Adherence to participant flow diagrams in trials on postoperative pain management after total hip and knee arthroplasty: a methodological review

Thea Nørgaard Rønsbo, Jens Laigaard, Casper Pedersen, Ole Mathiesen, Anders Peder Højer Karlsen

Efficiency of atorvastatin on in-hospital mortality of patients with acute aortic dissection (AAD): study protocol for a randomized, open-label, superiority clinical trial

Yequn Chen, Nianling Xiong, Xin Wang, Shiwan Wu, Liangli Hong, Xiru Huang, Chang Chen, Weiping Li, Bin Wang, Shu Ye, Xuerui Tan

Bedside Ultrasound Conducted in Kids with distal upper Limb fractures in the Emergency Department (BUCKLED): a protocol for an open-label non-inferiority diagnostic randomised controlled trial

Peter J. Snelling, Gerben Keijzers, Joshua Byrnes, David Bade, Shane George, Mark Moore, Philip Jones, Michelle Davison, Rob Roan, Robert S. Ware

Clinical, microbiological, and immunological effects of systemic probiotics in periodontal treatment: study protocol for a randomized controlled trial

Belen Retamal-Valdes, Wim Teughels, Laryssa Macedo Oliveira, Rebeca Nascimento da Silva, Aretuza Fritoli, Patricia Gomes, Geisla Mary Silva Soares, Natalie Temporão, Camila Pinheiro Furquim, Poliana Mendes Duarte, Helio Doyle, Marcelo Faveri, Luciene Cristina Figueiredo, Magda Feres

A prospective multicenter assessor-blinded randomized controlled study to compare the efficacy of short versus long protocols of electroconvulsive therapy as an augmentation strategy to clozapine in patients with ultra-resistant schizophrenia (SURECT study)

Virginie Moulier, Mohamed Wassim Krir, Marine Dalmont, Bilal Bendib, Caroline Berjamin, Chérifa Benosman, Emeline Duhamel, Pierre Quesada, Benjamin Letertre, Jacques Bénichou, Vincent Compere, Clélia Quiles, Anne Sauvaget, Samuel Bulteau, Jean-Marie Vanelle, Edouard Laforgue, Antoine Yrondi, Etienne Véry, Marie Sporer, Christophe Arbus, Sonia Dollfus, Pierrick Lebain, Nemat Jaafari, Marie-Odile Krebs, Marion Plaze, Dominique Drapier, Patrick Le Bihan, Caroline Dubertret, Jérôme Attal, Pierre-Michel Llorca, Louis Foures, Dominique Januel, Noomane Bouaziz, Olivier Guillin, Maud Rothärmel

Stereotactic cisternal lavage in patients with aneurysmal subarachnoid hemorrhage with urokinase and nimodipine for the prevention of secondary brain injury (SPLASH): study protocol for a randomized controlled trial

Roland Roelz, Fabian Schubach, Volker A. Coenen, Carolin Jenkner, Christian Scheiwe, Jürgen Grauvogel, Wolf-Dirk Niesen, Horst Urbach, Christian Taschner, Jochen Seufert, Jürgen Kätzler, Jürgen Beck, Peter C. Reinacher

Lifestyle, Exercise and Activity Package for People living with Progressive Multiple Sclerosis (LEAP-MS): adaptions during the COVID-19 pandemic and remote delivery for improved efficiency

Rachel Lowe, Christy Barlow, Barry Lloyd, Julie Latchem-Hastings, Vincent Poile, Charlotte Scoble, Andrew Dean-Young, Kate Button, Rebecca Playle, Monica Busse

Diaphragmatic paralysis, respiratory function, and postoperative pain after interscalene brachial plexus block with a reduced dose of 10 ml levobupivacaine 0.25% versus a 20 ml dose in patients undergoing arthroscopic shoulder surgery: study protocol for the randomized controlled double-blind REDOLEV study

P. Oliver-Fornies, J. P. Ortega Lahuerta, R. Gomez Gomez, I. Gonzalo Pellicer, L. Oliden Gutierrez, J. Viñuales Cabeza, L. Gallego Ligorit, C. E. Orellana Melgar

A randomised, double-blind, placebo-controlled, pilot trial of intravenous plasma purified alpha-1 antitrypsin for SARS-CoV-2-induced Acute Respiratory Distress Syndrome: a structured summary of a study protocol for a randomised, controlled trial

Natalie L. McEvoy, Jennifer L. Clarke, Oliver J. Mc Elvaney, Oisin F. Mc Elvaney, Fiona Boland, Deirdre Hyland, Pierce Geoghegan, Karen Donnelly, Oisin Friel, Ailbhe Cullen, Ann M. Collins, Daniel Fraughen, Ignacio Martin-Loeches, Martina Hennessy, John G. Laffey, Noel G. Mc Elvaney, Gerard F. Curley

A virtual reality-based intervention for surgical patients: study protocol of a randomized controlled trial

Raluca Diana Georgescu, Anca Dobrean, Cristina Alina Silaghi, Horatiu Silaghi

The ACTyourCHANGE study protocol: promoting a healthy lifestyle in patients with obesity with Acceptance and Commitment Therapy—a randomized controlled trial

Anna Guerrini Usubini, Roberto Cattivelli, Emanuele Maria Giusti, Francesco Vailati Riboni, Giorgia Varallo, Giada Pietrabissa, Gian Mauro Manzoni, Simone Consoli, Ilaria Bastoni, Valentina Granese, Clarissa Volpi, Valentina Villa, Annalisa Caretti, Michela Bottacchi, Gianluca Castelnuovo, Enrico Molinari

Protocol for a randomized pilot study (FIRST STEPS): implementation of the Incredible Years-ASLD® program in Spanish children with autism and preterm children with communication and/or socialization difficulties

Fátima Valencia, Elena Urbiola, Marina Romero-González, Inmaculada Navas, María Elías, Alexandra Garriz, Almudena Ramírez, Laia Villalta

The effects of nano-curcumin as a nutritional strategy on clinical and inflammatory factors in children with cystic fibrosis: the study protocol for a randomized controlled trial

Saeedeh Talebi, Mahammad Safarian, Mahmood Reza Jaafari, Seyed Javad Sayedi, Zahra Abbasi, Golnaz Ranjbar, Hamid Reza Kianifar

Development and validation of a web-based patient decision aid for immunotherapy for patients with metastatic melanoma: study protocol for a multicenter randomized trial

Pia Grabbe, Kathrin M. Gschwendtner, Imad Maatouk, Sophia B. Strobel, Martin Salzmann, Julia Bossert, Wolfgang Eich, Beate Wild, Friedegund Meier, Jessica C. Hassel, Christiane Bieber

A double-blinded, placebo-controlled randomized trial evaluating the efficacy and safety of Zhigancao Tang granules for treating HFpEF: study protocol for a randomized controlled trial

Na Zhang, Yingli Zhao, Yu Liu, Nuo Tang, Wang Zheng, Meijiao Mao, Qingcheng Liu, Lin Shen, Bing Deng

Effect of acupotomy in knee osteoarthritis patients: study protocol for a randomized controlled trial

Danghan Xu, Minghui Lee, Cihui Huang, Jia Wei, Mengxue Zhou, Taotao Yao, Jingjing Lu, Wenjing Zhao, Nuo Xu, Ruina Huang, Jun He, Liang Zheng

The UPTAKE study: implications for the future of COVID-19 vaccination trial recruitment in UK and beyond

Sonika Sethi, Aditi Kumar, Anandadeep Mandal, Mohammed Shaikh, Claire A. Hall, Jeremy M. W. Kirk, Paul Moss, Matthew J. Brookes, Supratik Basu

Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPO2CH): statistical analysis plan of a randomised controlled multicentre superiority trial

S. W. de Jonge, N. Wolfhagen, A. H. Zwinderman, M. W. Hollmann, M. A. Boermeester, M. G. W. Dijkgraaf, Q. J. J. Boldingh, W. J. Bom, A. Demirkiran, O. E. van Geffen, E. R. Hendriks, J. P. Hering, J. A. B. van der Hoeven, E. B. Kluyver, B. M. F. van der Leeuw, L. R. C. W. van Lonkhuijzen, L. M. Posthuma, D. J. A. Sonneveld, J. C. G. Scheijmans

Using behavioral theory and shared decision-making to understand clinical trial recruitment: interviews with trial recruiters

Jamie C. Brehaut, Carolina Lavin Venegas, Natasha Hudek, Justin Presseau, Kelly Carroll, Marc Rodger

The effectiveness of a modified Gui Zhi Fu Ling Wan formulation (Gynoclear™) for the treatment of endometriosis: a study protocol for a placebo-controlled, double-blind, randomised controlled trial

Mike Armour, Mahmoud A. Al-Dabbas, Carolyn Ee, Caroline A. Smith, Jane Ussher, Susan Arentz, Kenny Lawson, Jason Abbott

The Lutein and Zeaxanthin in Pregnancy (L-ZIP) study—carotenoid supplementation during pregnancy: ocular and systemic effects—study protocol for a randomized controlled trial

Emmanuel Kofi Addo, Aruna Gorusupudi, Susan Allman, Paul S. Bernstein

Ceftolozane-tazobactam versus meropenem for definitive treatment of bloodstream infection due to extended-spectrum beta-lactamase (ESBL) and AmpC-producing Enterobacterales (“MERINO-3”): study protocol for a multicentre, open-label randomised non-inferiority trial

Adam G. Stewart, Patrick N. A. Harris, Mark D. Chatfield, Roberta Littleford, David L. Paterson

MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers

Robin J. Murphy, Rachael L. Sumner, William Evans, David Menkes, Ingo Lambrecht, Rhys Ponton, Frederick Sundram, Nicholas Hoeh, Sanya Ram, Lisa Reynolds, Suresh Muthukumaraswamy

Statistical analysis plan for the COMPARE trial: a 3-arm randomised controlled trial comparing the effectiveness of Constraint-induced Aphasia Therapy Plus and Multi-modality Aphasia Therapy to usual care in chronic post-stroke aphasia (COMPARE)

Miranda L. Rose, Tapan Rai, David Copland, Lyndsey Nickels, Leanne Togher, Marcus Meinzer, Erin Godecke, Joosup Kim, Dominique A. Cadilhac, Melanie Hurley, Cassie Wilcox, Marcella Carragher

Clinical effects of breast milk enema on meconium evacuation in premature infants: study protocol for a randomized controlled trial

Liqiang Zheng, Li Gai, Jinyue Gao, Chaonan Kong, Yali Wang, Fangli Sun, Sitong Liu, Xinying Yu, Fan Yang, Hong Jiang

Evaluating the effectiveness and utility of a novel culturally-adapted telemonitoring system in improving the glycaemic control of Asians with type-2 diabetes mellitus: a mixed method study protocol

Kuan Liang Shawn Goh, Cia Sin Lee, Choon Huat Gerald Koh, Ng Ling Ling, Seng Bin Ang, Christina Oh, Yongqing Lin, Wei Yuan, Qishi Charles Zheng, Ngiap Chuan Tan

Systematic review of the use of translated patient-reported outcome measures in cancer trials

A. L. Slade, A. Retzer, K. Ahmed, D. Kyte, T. Keeley, J. Armes, J. M. Brown, L. Calman, A. Gavin, A. W. Glaser, D. M. Greenfield, A. Lanceley, R. M. Taylor, G. Velikova, G. Turner, M. J. Calvert

Does the guided online cognitive behavioral therapy for insomnia “i-Sleep youth” improve sleep of adolescents and young adults with insomnia after childhood cancer? (MICADO-study): study protocol of a randomized controlled trial

Shosha H. M. Peersmann, Annemieke van Straten, Gertjan J. L. Kaspers, Adriana Thano, Esther van den Bergh, Martha A. Grootenhuis, Raphaële R. L. van Litsenburg

Pressure Relieving Support Surfaces: a Randomised Evaluation 2 (PRESSURE 2): using photography for blinded central endpoint review

Elizabeth McGinnis, Isabelle L Smith, Howard Collier, Lyn Wilson, Susanne Coleman, Nikki Stubbs, Sarah Brown, Rachael Gilberts, Valerie Henderson, Kay Walker, E. Andrea Nelson, Jane Nixon

Efficacy and safety of nelfinavir in asymptomatic and mild COVID-19 patients: a structured summary of a study protocol for a multicenter, randomized controlled trial

Naoki Hosogaya, Taiga Miyazaki, Yuri Fukushige, Sachiko Takemori, Shinpei Morimoto, Hiroshi Yamamoto, Makoto Hori, Tomoya Kurokawa, Yohei Kawasaki, Michiko Hanawa, Yasuhisa Fujii, Hideki Hanaoka, Shingo Iwami, Koichi Watashi, Satoshi Yamagoe, Yoshitsugu Miyazaki, Takaji Wakita, Koichi Izumikawa, Katsunori Yanagihara, Hiroshi Mukae, Shigeru Kohno, Hiroshi Yotsuyanagi, Yasuyuki Kato, Tetsuya Matsumoto, Norihito Tarumoto, Satoshi Shiraishi, Hiroshi Ishii, Hideaki Ohno, Kazuhiro Yatera, Yoshihiro Yamamoto, Hiroshi Kakeya

Natural tannin extracts supplementation for COVID-19 patients (TanCOVID): a structured summary of a study protocol for a randomized controlled trial

Silvia Molino, Andrea Pisarevsky, Fabiana Lopez Mingorance, Patricia Vega, Juan Pablo Stefanolo, Julieta Repetti, Guillermina Ludueña, Pablo Pepa, Juan Ignacio Olmos, Marcelo Rodriguez Fermepin, Tatiana Uehara, Sonia Villapol, Tor Savidge, Todd Treangen, Elisa Viciani, Andrea Castagnetti, Maria Marta Piskorz

The impact of theory-based messages on COVID-19 vaccination intentions: a structured summary of a study protocol for a randomised controlled trial

Ben Young, Marie Kotzur, Lauren Gatting, Carissa Bonner, Julie Ayre, Alex McConnachie, Carys Batcup, Kirsten McCaffery, Ronan O’Carroll, Kathryn A. Robb

Use of probiotics to reduce infections and death and prevent colonization with extended-spectrum beta-lactamase (ESBL)-producing bacteria among newborn infants in Tanzania (ProRIDE Trial): study protocol for a randomized controlled clinical trial

Kanika Kuwelker, Nina Langeland, Iren Høyland Löhr, Joshua Gidion, Joel Manyahi, Sabrina John Moyo, Bjørn Blomberg, Claus Klingenberg

Radiofrequency ablation and chemotherapy versus chemotherapy alone for locally advanced pancreatic cancer (PELICAN): study protocol for a randomized controlled trial

M. S. Walma, S. J. Rombouts, L. J. H. Brada, I. H. Borel Rinkes, K. Bosscha, R. C. Bruijnen, O. R. Busch, G. J. Creemers, F. Daams, R. M. van Dam, O. M. van Delden, S. Festen, P. Ghorbani, D. J. de Groot, J. W. B. de Groot, N. Haj Mohammad, R. van Hillegersberg, I. H. de Hingh, M. D’Hondt, E. D. Kerver, M. S. van Leeuwen, M. S. Liem, K. P. van Lienden, M. Los, V. E. de Meijer, M. R. Meijerink, L. J. Mekenkamp, C. Y. Nio, I. Oulad Abdennabi, E. Pando, G. A. Patijn, M. B. Polée, J. F. Pruijt, G. Roeyen, J. A. Ropela, M. W. J. Stommel, J. de Vos-Geelen, J. J. de Vries, E. M. van der Waal, F. J. Wessels, J. W. Wilmink, H. C. van Santvoort, M. G. Besselink, I. Q. Molenaar

Statistical analysis plan for the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) trial: a randomized controlled trial of a specialist palliative care intervention for patients undergoing surgery for cancer

Onur M. Orun, Myrick C. Shinall Jr., Aimee Hoskins, Ellis Morgan, Mohana Karlekar, Sara F. Martin, E. Wesley Ely, Rameela Raman

Acupuncture for comorbid mild-moderate depression and chronic musculoskeletal pain: study protocol for a randomized controlled trial

Sheng Li, Jing Liu, Jianpeng Huang, Ding Luo, Qian Wu, Baile Ning, Ling Chen, Jianhua Liu, Wen-Bin Fu

Can we decrease the duration of basal thumb joint distraction for early osteoarthritis from 8 to 6 weeks? Study protocol for a non-inferiority randomized controlled trial

Janna S. E. Ottenhoff, Teun Teunis, Assa Braakenburg, Aebele B. Mink van der Molen

Levetiracetam versus fosphenytoin as a second-line treatment after diazepam for status epilepticus: study protocol for a multicenter non-inferiority designed randomized control trial

Kensuke Nakamura, Aiki Marushima, Yuji Takahashi, Akio Kimura, Masahiro Asami, Satoshi Egawa, Junya Kaneko, Yutaka Kondo, Chikara Yonekawa, Eisei Hoshiyama, Takeshi Yamada, Kazushi Maruo, Yoshiaki Inoue

The effect of omega-3 long chain polyunsaturated fatty acids on aggressive behaviour in adult male prisoners: a structured study protocol for a multi-centre, double-blind, randomised placebo-controlled trial and translation into policy and practice

Barbara J. Meyer, Mitchell K. Byrne, Colin H. Cortie, Natalie Parletta, Alison Jones, Simon Eckermann, Tony Butler, David Greenberg, Marijka Batterham, Francesca Fernandez, Peter W. Schofield, Pia C. Winberg, Kate Bowles, Jean Dally, Anne-Maria Martin, Luke Grant

Connecting the Dots: a cluster-randomized clinical trial integrating standardized autism spectrum disorders screening, high-quality treatment, and long-term outcomes

Leslie A. McClure, Nora L. Lee, Katherine Sand, Giacomo Vivanti, Deborah Fein, Aubyn Stahmer, Diana L. Robins

Recruiting for research on sensitive topics in schools: an experience with Vaxcards, a collectable vaccine card game

D. S. Epstein, J. C. Enticott, H. J. Larson, C. Barton

Continuous erector spinae plane block versus thoracic epidural analgesia in video-assisted thoracic surgery: a study protocol for a prospective randomized open label non-inferiority trial

R. J. C. van den Broek, J. S. H. A. Koopman, J. M. C. Postema, N. J. Verberkmoes, K. J. Chin, R. A. Bouwman, B. J. B. Versyck

Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research

Ciska Verbaanderd, Ilse Rooman, Isabelle Huys

Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial

Philippe Bégin, Jeannie Callum, Nancy M. Heddle, Richard Cook, Michelle P. Zeller, Alan Tinmouth, Dean A. Fergusson, Melissa M. Cushing, Marshall J. Glesby, Michaël Chassé, Dana V. Devine, Nancy Robitalle, Renée Bazin, Nadine Shehata, Andrés Finzi, Allison McGeer, Damon C. Scales, Lisa Schwartz, Alexis F. Turgeon, Ryan Zarychanski, Nick Daneman, Richard Carl, Luiz Amorim, Caroline Gabe, Martin Ellis, Bruce S. Sachais, Kent Cadogan Loftsgard, Erin Jamula, Julie Carruthers, Joanne Duncan, Kayla Lucier, Na Li, Yang Liu, Chantal Armali, Amie Kron, Dimpy Modi, Marie-Christine Auclair, Sabrina Cerro, Meda Avram, Donald M. Arnold

Can patient-led surveillance detect subsequent new primary or recurrent melanomas and reduce the need for routinely scheduled follow-up? A protocol for the MEL-SELF randomised controlled trial

Deonna M. Ackermann, Amelia K. Smit, Monika Janda, Cathelijne H. van Kemenade, Mbathio Dieng, Rachael L. Morton, Robin M. Turner, Anne E. Cust, Les Irwig, Jolyn K. Hersch, Pascale Guitera, H. Peter Soyer, Victoria Mar, Robyn P. M. Saw, Donald Low, Cynthia Low, Dorothy Drabarek, David Espinoza, Jon Emery, Peter Murchie, John F. Thompson, Richard A. Scolyer, Anthony Azzi, Alister Lilleyman, Katy J. L. Bell

The effect of automated audit and feedback on data completeness in the electronic health record of the general physician: protocol for a cluster randomized controlled trial

Steve Van den Bulck, Tine De Burghgraeve, Willem Raat, Pavlos Mamouris, Patrick Coursier, Patrik Vankrunkelsven, Geert Goderis, Rosella Hermens, Gijs Van Pottelbergh, Bert Vaes

Effects of different ischemic preconditioning occlusion pressures on muscle damage induced by eccentric exercise: a study protocol for a randomized controlled placebo clinical trial

Eduardo Pizzo Junior, Allysiê Priscilla de Souza Cavina, Leonardo Kesrouani Lemos, Taíse Mendes Biral, Carlos Marcelo Pastre, Franciele Marques Vanderlei

Mental health specialist video consultations versus treatment as usual in patients with depression or anxiety disorders in primary care: study protocol for an individually randomised superiority trial (the PROVIDE-C trial)

Markus W. Haun, Justus Tönnies, Regina Krisam, Dorothea Kronsteiner, Michel Wensing, Joachim Szecsenyi, Markus Vomhof, Andrea Icks, Beate Wild, Mechthild Hartmann, Hans-Christoph Friederich

Effect of intensive care unit-specific virtual reality (ICU-VR) to improve psychological well-being and quality of life in COVID-19 ICU survivors: a study protocol for a multicentre, randomized controlled trial

Johan H. Vlake, Jasper Van Bommel, Evert-Jan Wils, Tim I. M. Korevaar, Merel E. Hellemons, Anna F. C. Schut, Joost A. M. Labout, Lois L. H. Schreuder, Diederik Gommers, Michel E. Van Genderen

Monitoring of patients with microdialysis following pancreaticoduodenectomy—the MINIMUM study: study protocol for a randomized controlled trial

Espen Lindholm, Nil Ekiz, Tor Inge Tønnessen

Neurocognitive Empowerment for Addiction Treatment (NEAT): study protocol for a randomized controlled trial

Hamed Ekhtiari, Tara Rezapour, Brionne Sawyer, Hung-Wen Yeh, Rayus Kuplicki, Mimi Tarrasch, Martin P Paulus, Robin Aupperle

Active elderly and health—can moderate exercise improve health and wellbeing in older adults? Protocol for a randomized controlled trial

Mauro Giovanni Carta, Giulia Cossu, Elisa Pintus, Rosanna Zoccheddu, Omar Callia, Giuliana Conti, Mirra Pintus, Cesar Ivan Aviles Gonzalez, Maria Valeria Massidda, Gioia Mura, Claudia Sardu, Paolo Contu, Luigi Minerba, Roberto Demontis, Massimiliano Pau, Gabriele Finco, Eleonora Cocco, Maria Petronilla Penna, Germano Orrù, Goce Kalcev, Federico Cabras, Stefano Lorrai, Andrea Loviselli, Fernanda Velluzzi, Marco Monticone, Enrico Cacace, Mario Musu, Franco Rongioletti, Alberto Cauli, Valeria Ruggiero, Alessandra Scano, Antonio Crisafulli, Sofia Cosentino, Laura Atzori, Elena Massa, Quirico Mela, Dario Fortin, Gianmario Migliaccio, Antonio Egidio Nardi, Matthias Angermeyer, Antonio Preti

The cost of community research—recruiting community-dwelling participants to a feasibility primary care cluster randomised controlled trial

Nicola Harrison, Caroline Brundle, Anne Heaven, Andrew Clegg

Whole School SEND (WSS) Review: study protocol for a two-arm pragmatic parallel cluster randomised controlled trial in 160 English secondary schools

Stephen Morris, Andrew Smith, Cathy Lewin, Peter Hick, Jordan Harrison

Correction to: MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers

Robin J. Murphy, Rachael L. Sumner, William Evans, David Menkes, Ingo Lambrecht, Rhys Ponton, Frederick Sundram, Nicholas Hoeh, Sanya Ram, Lisa Reynolds, Suresh Muthukumaraswamy

Improvement of freezing of gait in patients with Parkinson’s disease by music exercise therapy: a study protocol for a randomized controlled trial

Kun-Peng Li, Zong-Lei Zhou, Ru-Zhen Zhou, Yan Zhu, Zeng-Qiao Zhang

Efficacy and safety of Naoxintong capsule for treating chronic stable angina: study protocol for a randomized controlled trial

Gao Huanjia, Cai Hairong, Zhuang Jieqin, Dai Xingzhen, Fu Xue, Zhang Weizhang, Chen Bojun

Developing the INCLUDE Ethnicity Framework—a tool to help trialists design trials that better reflect the communities they serve

Shaun Treweek, Katie Banister, Peter Bower, Seonaidh Cotton, Declan Devane, Heidi R. Gardner, Talia Isaacs, Gary Nestor, Adepeju Oshisanya, Adwoa Parker, Lynn Rochester, Irene Soulsby, Hywel Williams, Miles D. Witham

Effects of Bilberry and Oat intake on lipids, inflammation and exercise capacity after Acute Myocardial Infarction (BIOAMI): study protocol for a randomized, double-blind, placebo-controlled trial

Cecilia Bergh, Rikard Landberg, Kristina Andersson, Lovisa Heyman-Lindén, Ana Rascón, Anders Magnuson, Payam Khalili, Amra Kåregren, Johan Nilsson, Carlo Pirazzi, David Erlinge, Ole Fröbert

Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET)

Marcus Bateman, Jonathan P. Evans, Viana Vuvan, Val Jones, Adam C. Watts, Joideep Phadnis, Leanne Bisset, Bill Vicenzino

Accessing routinely collected health data to improve clinical trials: recent experience of access

Archie Macnair, Sharon B. Love, Macey L. Murray, Duncan C. Gilbert, Mahesh K. B. Parmar, Tom Denwood, James Carpenter, Matthew R. Sydes, Ruth E. Langley, Fay H. Cafferty

Factors contributing to cognitive improvement effects of acupuncture in patients with mild cognitive impairment: a pilot randomized controlled trial

Jae-Hong Kim, Myoung-Rae Cho, Jeong-Cheol Shin, Gwang-Cheon Park, Jeong-Soon Lee

Randomized clinical trial to evaluate safety and efficacy of convalescent plasma use among hospitalized patients with COVID-19 (PERUCONPLASMA): a structured summary of a study protocol for a randomized controlled trial

Alonso Soto, Fiorella Krapp, Alex Vargas, Lucía Cabrejos, Enrique Argumanis, Patricia L. García, Karina Altamirano, Martín Montes, Pamela R. Chacón-Uscamaita, Patricia J. García

Reconvalescent plasma/camostat mesylate in early SARS-CoV-2 Q-PCR positive high-risk individuals (RES-Q-HR): a structured summary of a study protocol for a randomized controlled trial

Verena Keitel, Björn Jensen, Torsten Feldt, Johannes C. Fischer, Johannes G. Bode, Christiane Matuschek, Edwin Bölke, Wilfried Budach, Christian Plettenberg, Kathrin Scheckenbach, Detlef Kindgen-Milles, Jörg Timm, Lisa Müller, Henrike Kolbe, Andreas Stöhr, Christian Calles, Andreas Hippe, Pablo Verde, Christoph D. Spinner, Jochen Schneider, Timo Wolf, Winfried V. Kern, Jacob Nattermann, Alexander Zoufaly, Christian Ohmann, Tom Luedde, Simon Labuhn, Noemi Freise, Alexander Killer, Caroline Klindt, Carola Dröge, Anselm Kunstein, David Schoeler, Sandra Jost, Erik Lehnert, Stefanie Ackerstaff, Timo Brandenburger, Christina Westhoff, Christine Fritsch, Stephanie Laer, Andrea Icks

Nutrition-focused group intervention with a strength-based counseling approach for people with clinical depression: a study protocol for the Food for Mind randomized controlled trial

Johanna Roponen, Anu Ruusunen, Pilvikki Absetz, Timo Partonen, Virpi Kuvaja-Köllner, Mika Hujo, Outi Nuutinen

Updated protocol of the SANO trial: a stepped-wedge cluster randomised trial comparing surgery with active surveillance after neoadjuvant chemoradiotherapy for oesophageal cancer

Ben M. Eyck, Berend J. van der Wilk, Bo Jan Noordman, Bas P. L. Wijnhoven, Sjoerd M. Lagarde, Henk H. Hartgrink, Peter Paul L. O. Coene, Jan Willem T. Dekker, Michail Doukas, Ate van der Gaast, Joos Heisterkamp, Ewout A. Kouwenhoven, Grard A. P. Nieuwenhuijzen, Jean-Pierre E. N. Pierie, Camiel Rosman, Johanna W. van Sandick, Maurice J. C. van der Sangen, Meindert N. Sosef, Edwin S. van der Zaag, Manon C. W. Spaander, Roelf Valkema, Hester F. Lingsma, Ewout W. Steyerberg, J. Jan B. van Lanschot

Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): statistical analysis plan for a randomised controlled trial assessing the effectiveness of peri-articular liposomal bupivacaine plus bupivacaine hydrochloride compared with bupivacaine hydrochloride alone

Jamie R. Stokes, Ariel Wang, Lisa Poulton, Ines Rombach, Hemant Pandit, Ruth Knight

Parent engagement in co-design of clinical trials: the PARENT trial

Leigh M. Vanderloo, Shelley M. Vanderhout, Erika Tavares, Jonathon Maguire, Sharon Straus, Catherine S. Birken

Comparison of a fast track protocol and standard care after hip arthroplasty in the reduction of the length of stay and the early weight-bearing resumption: study protocol for a randomized controlled trial

Martina Rocchi, Cesare Stagni, Marco Govoni, Alessandro Mazzotta, Leonardo Vivarelli, Antonella Orlandi Magli, Mariada Perrone, Maria Grazia Benedetti, Dante Dallari

Effect of hydroxychloroquine on COVID-19 prevention in cancer patients undergoing treatment: study protocol for a randomized controlled trial

H. Rahimi, A. Allahyari, S. Ataei Azimi, M. Kamandi, Z. Mozaheb, F. Zemorshidi, M. Khadem-Rezaiyan, A. Bary, M. Seddigh-Shamsi, M. Moeini Nodeh

Intraoperative ultrasound-guided compared to stereotactic navigated ventriculoperitoneal shunt placement: study protocol for a randomised controlled study

Severina Leu, Florian Halbeisen, Luigi Mariani, Jehuda Soleman

Protective mechanical ventilation with optimal PEEP during RARP improves oxygenation and pulmonary indexes

Jianwei Zhou, Chuanguang Wang, Ran Lv, Na Liu, Yan Huang, Wu Wang, Lina Yu, Junran Xie

Different limb lengths in gastric bypass surgery: study protocol for a Swiss multicenter randomized controlled trial (SLIM)

Marko Kraljević, Romano Schneider, Bettina Wölnerhanssen, Marco Bueter, Tarik Delko, Ralph Peterli

Correction to: A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences

Samina Ali, Gareth Hopkin, Naveen Poonai, Lawrence Richer, Maryna Yaskina, Anna Heath, Terry Paul Klassen, Chris McCabe

Heterogeneity in design and analysis of ICU delirium randomized trials: a systematic review

Elizabeth Colantuoni, Mounica Koneru, Narjes Akhlaghi, Ximin Li, Mohamed D. Hashem, Victor D. Dinglas, Karin J. Neufeld, Michael O. Harhay, Dale M. Needham

The Drinkers’ Intervention to Prevent Tuberculosis (DIPT) trial among heavy drinkers living with HIV in Uganda: study protocol of a 2×2 factorial trial

Sara Lodi, Nneka I. Emenyonu, Kara Marson, Dalsone Kwarisiima, Robin Fatch, Michael G. McDonell, Debbie M. Cheng, Harsha Thirumurthy, Monica Gandhi, Carol S. Camlin, Winnie R. Muyindike, Judith A. Hahn, Gabriel Chamie

Efficacy of capacitive resistive monopolar radiofrequency in the physiotherapeutic treatment of chronic pelvic pain syndrome: study protocol for a randomized controlled trial

A. Carralero-Martínez, M. A. Muñoz Pérez, R. Pané-Alemany, L. Blanco-Ratto, S. Kauffmann, I. Ramírez-García

Including random centre effects in design, analysis and presentation of multi-centre trials

Kate Edgar, Ian Roberts, Linda Sharples

Comparative efficacy of a single-session “Empowered Relief” videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial

Maisa S. Ziadni, Steven R. Anderson, Lluvia Gonzalez-Castro, Beth D. Darnall

Effects of cycling workstation to get tertiary employee moving on their overall health: study protocol for a REMOVE trial

Terry Guirado, Lore Metz, Bruno Pereira, Audrey Bergouignan, David Thivel, Martine Duclos

Assessment of a combined strategy of seasonal malaria chemoprevention and supplementation with vitamin A, zinc and Plumpy’Doz™ to prevent malaria and malnutrition in children under 5 years old in Burkina Faso: a randomized open-label trial (SMC-NUT)

Paul Sondo, Marc Christian Tahita, Toussaint Rouamba, Karim Derra, Bérenger Kaboré, Cheick Saïd Compaoré, Florence Ouédraogo, Eli Rouamba, Hamidou Ilboudo, Estelle Aïssa Bambara, Macaire Nana, Edmond Yabré Sawadogo, Hermann Sorgho, Athanase Mwinessobaonfou Somé, Innocent Valéa, Prabin Dahal, Maminata Traoré/Coulibaly, Halidou Tinto

Providing trial results to participants in phase III pragmatic effectiveness RCTs: a scoping review

Hanne Bruhn, Elle-Jay Cowan, Marion K. Campbell, Lynda Constable, Seonaidh Cotton, Vikki Entwistle, Rosemary Humphreys, Karen Innes, Sandra Jayacodi, Peter Knapp, Annabelle South, Katie Gillies

Mediterranean diet, Mindfulness-Based Stress Reduction and usual care during pregnancy for reducing fetal growth restriction and adverse perinatal outcomes: IMPACT BCN (Improving Mothers for a better PrenAtal Care Trial BarCeloNa): a study protocol for a randomized controlled trial

Francesca Crovetto, Fàtima Crispi, Roger Borras, Cristina Paules, Rosa Casas, Andrés Martín-Asuero, Angela Arranz, Eduard Vieta, Ramon Estruch, Eduard Gratacós

The UPMC OPTIMISE-C19 (OPtimizing Treatment and Impact of Monoclonal antIbodieS through Evaluation for COVID-19) trial: a structured summary of a study protocol for an open-label, pragmatic, comparative effectiveness platform trial with response-adaptive randomization

David T. Huang, Erin K. McCreary, J. Ryan Bariola, Richard J. Wadas, Kevin E. Kip, Oscar C. Marroquin, Stephen Koscumb, Kevin Collins, Judith A. Shovel, Mark Schmidhofer, Mary Kay Wisniewski, Colleen Sullivan, Donald M. Yealy, Meredith Axe, David A. Nace, Ghady Haidar, Tina Khadem, Kelsey Linstrum, Graham M. Snyder, Christopher W. Seymour, Stephanie K. Montgomery, Bryan J. McVerry, Lindsay Berry, Scott Berry, Russell Meyers, Alexandra Weissman, Octavia M. Peck-Palmer, Alan Wells, Robert Bart, Debbie L. Albin, Tami Minnier, Derek C. Angus

VITADIAL “Does correction of 25 OH-VITAmin D with cholecalciferol supplementation increase muscle strength in hemoDIALysis patients?”: study protocol for a randomized controlled trial

Stanislas Bataille, Nathalie Pedinielli, Elisa Carreno, Mathilde Prezelin-Reydit, Philippe Chauveau, Guillaume Jean, Thomas Robert, Mickaël Bobot, Guillaume Seret, Elisabeth Jouve, Frederic Lavainne, Marianne Serveaux, Laurence Vrigneaud, Stéphanie Gentile

The efficacy of repetitive transcranial magnetic stimulation (rTMS) for young individuals with high-level perceived stress: study protocol for a randomized sham-controlled trial

Jingsong Wu, Mengyu Han, Youze He, Xiaoting Xie, Jian Song, Xiujuan Geng

Optimising AVATAR therapy for people who hear distressing voices: study protocol for the AVATAR2 multi-centre randomised controlled trial

Philippa Garety, Clementine J. Edwards, Thomas Ward, Richard Emsley, Mark Huckvale, Paul McCrone, Mar Rus-Calafell, Miriam Fornells-Ambrojo, Andrew Gumley, Gillian Haddock, Sandra Bucci, Hamish McLeod, Amy Hardy, Emmanuelle Peters, Inez Myin-Germeys, Thomas Craig

Individualized, low-cost and accessible pulmonary rehabilitation program based on functional clinical tests for individuals with COPD—a study protocol of a randomized controlled trial

Marcela Maria Carvalho da Silva, Juliano Ferreira Arcuri, Valéria Amorim Pires Di Lorenzo

Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes

Jennifer L. Bell, Samir Gupta, Edmund Juszczak, Pollyanna Hardy, Louise Linsell

Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Ramy Khojaly, Ruairí Mac Niocaill, Muhammad Shahab, Matthew Nagle, Colm Taylor, Fiachra E. Rowan, May Cleary

Chemoprophylaxis trial designs in epidemics: insights from a systematic review of COVID-19 study registrations

Lakshmi Manoharan, Piero Olliaro, Peter W. Horby, Conall H. Watson

TB research requires strong protections, innovation, and increased funding in response to COVID-19

B. T. Nyang’wa, A. N. LaHood, C. D. Mitnick, L. Guglielmetti

Fidelity is not easy! Challenges and guidelines for assessing fidelity in complex interventions

Liane R. Ginsburg, Matthias Hoben, Adam Easterbrook, Ruth A. Anderson, Carole A. Estabrooks, Peter G. Norton

Acceptability of a COVID-19 pre-exposure prophylaxis trial with hydroxychloroquine in French healthcare workers during the first wave of COVID-19 pandemic

Amandine Gagneux-Brunon, Clémentine Schilte, Arnauld Garcin, Nathalie Jolly, Muriel Vray, Laura Schaeffer, Xavier Duval, Bruno Hoen, Elisabeth Botelho-Nevers

Measuring the effectiveness of integrated vector management with targeted outdoor residual spraying and autodissemination devices on the incidence of dengue in urban Malaysia in the iDEM trial (intervention for Dengue Epidemiology in Malaysia): study protocol for a cluster randomized controlled trial

Mitra Saadatian-Elahi, Neal Alexander, Tim Möhlmann, Carole Langlois-Jacques, Remco Suer, Nazni Wasi Ahmad, Rose Nani Mudin, Farah Diana Ariffin, Frederic Baur, Frederic Schmitt, Jason H. Richardson, Muriel Rabilloud, Nurulhusna Ab Hamid

Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov—evaluation of a new tracking tool for the US clinical trial registry

Sarai Mirjam Keestra, Florence Rodgers, Daphne Lenz, Rhiannon Osborne, Till Bruckner, Sean Lee

Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial

Gernot Marx, Kai Zacharowski, Carole Ichai, Karim Asehnoune, Vladimír Černý, Rolf Dembinski, Ricard Ferrer Roca, Dietmar Fries, Zsolt Molnar, Peter Rosenberger, Manuel Sanchez-Sanchez, Tobias Schürholz, Tamara Dehnhardt, Sonja Schmier, Elke von Kleist, Ute Brauer, Tim-Philipp Simon

Endoscopic vacuum therapy versus stent treatment of esophageal anastomotic leaks (ESOLEAK): study protocol for a prospective randomized phase 2 trial

Michael Tachezy, Seung-Hun Chon, Isabel Rieck, Marcus Kantowski, Hildegard Christ, Karl Karstens, Florian Gebauer, Tobias Goeser, Thomas Rösch, Jakob R. Izbicki, Christiane J. Bruns

Safety and efficacy of Ayurvedic interventions and Yoga on long term effects of COVID-19: A structured summary of a study protocol for a randomized controlled trial

Babita Yadav, Amit Rai, Pallavi Suresh Mundada, Richa Singhal, B. C. S. Rao, Rakesh Rana, Narayanam Srikanth

A framework for handling missing accelerometer outcome data in trials

Mia S. Tackney, Derek G. Cook, Daniel Stahl, Khalida Ismail, Elizabeth Williamson, James Carpenter

Patient-Reported OUtcome measures in key African languages to promote Diversity in research and clinical practice (PROUD)—protocol for a systematic review of measurement properties

Martin Heine, Lidwine B. Mokkink, Chanel van Zyl, Wayne Derman, Susan Hanekom

Letter on “Sharing trial results directly with trial participants and other stakeholders after the SARS-CoV-2 pandemic hit the UK – experience from the ActWELL trial”

Hanne Bruhn, Annie S. Anderson, Amy Hickman, E. Jane Macaskill, Shaun Treweek

Maternal low-intensity psychosocial telemental interventions in response to COVID-19 in Qatar: study protocol for a randomized controlled trial

Sarah Naja, Rowaida Elyamani, Mohamad Chehab, Mohamed Siddig, Abdullah Al Ibrahim, Tagreed Mohamad, Rajvir Singh, Iheb Bougmiza

Assessing the efficacy of a stepped-care group treatment programme for borderline personality disorder: study protocol for a pragmatic trial

Judy A. Pickard, Adam Finch, Elizabeth Huxley, Michelle L. Townsend, Stephanie Deuchar, Kate L. Lewis, Jason Pratt, Brin F. S. Grenyer

Prophylaxis for patients at Risk to Eliminate Post-operative Atrial Fibrillation (PREP-AF trial): a protocol for a feasibility randomized controlled study

Heather A. Smith, Salmaan Kanji, Diem T. T. Tran, Calum Redpath, Dean Ferguson, Tori Lenet, Greg Sigler, Sebastien Gilbert, Donna Maziak, Patrick Villeneuve, Sudhir Sundaresan, Andrew J. E. Seely

SWE and SMI ultrasound techniques for monitoring needling treatment of ankylosing spondylitis: study protocol for a single-blinded randomized controlled trial

Mengyu Wang, Wen Fu, Lingcui Meng, Jia Liu, Lihua Wu, Yingjun Peng, Ziping Li

The cerebral mechanism of acupuncture for chronic insomnia with gastrointestinal disorder: protocol for a randomized controlled trial

Wei Peng, Xiaojuan Hong, Yaru Huangfu, Zhao Sun, Wei Shen, Fen Feng, Liang Gong, Zhifu Shen, Baojun Guo, Leixiao Zhang, Yanan Wang, Ying Zhao, Tianmin Zhu, Youping Hu, Siyi Yu

Auricular acupressure for myopia prevention and control in children and its effect on choroid and retina: a randomized controlled trial protocol

Rong Han, Xie-he Kong, Feng Zhao, Yan-ting Yang, Xiao-qing Dong, Li Zeng, Zhi Chen, Yue Zhao, Guang Yang, Jue Hong, Xing-tao Zhou, Xiao-peng Ma

The quality of intervention reporting in trials of therapeutic exercise for hip osteoarthritis: a secondary analysis of a systematic review

Louise C. Burgess, Thomas W. Wainwright, Khara A. James, Johan von Heideken, Maura D. Iversen

Evaluation of adherence monitoring system using evriMED with a differentiated response compared to standard of care among drug-sensitive TB patients in three provinces in South Africa: a protocol for a cluster randomised control trial

Noriah Maraba, Catherine Orrell, Candice M. Chetty-Makkan, Kavindhran Velen, Rachel Mukora, Liesl Page-Shipp, Pren Naidoo, M. Thulani Mbatha, Katherine L. Fielding, Salome Charalambous

Integrating pharmacists into aged care facilities to improve the quality use of medicine (PiRACF Study): protocol for a cluster randomised controlled trial

Sam Kosari, Jane Koerner, Mark Naunton, Gregory M. Peterson, Ibrahim Haider, Emily Lancsar, David Wright, Theo Niyonsenga, Rachel Davey

Impact of a mobile phone-based interactive voice response software on tuberculosis treatment outcomes in Uganda (CFL-TB): a protocol for a randomized controlled trial

Byonanebye Dathan Mirembe, Hope Mackline, Christine Sekaggya-Wiltshire, Agnes N. Kiragga, Mohammed Lamorde, Elizabeth Oseku, Rachel King, Rosalind Parkes-Ratanshi

Short-term effects of synchronized vs. non-synchronized NIPPV in preterm infants: study protocol for an unmasked randomized crossover trial

Francesco Cresi, Federica Chiale, Elena Maggiora, Silvia Maria Borgione, Mattia Ferroglio, Federica Runfola, Giulia Maiocco, Chiara Peila, Enrico Bertino, Alessandra Coscia

Polyphosphate (PolyP) for alveolar cleft repair: study protocol for a pilot randomized controlled trial

S. A. Alkaabi, D. S. Natsir Kalla, G. A. Alsabri, A. Fauzi, A. Tajrin, W. E. G. Müller, H. C. Schröder, X. G. Wang, T. Forouzanfar, M. N. Helder, M. Ruslin

The Brain in Motion II Study: study protocol for a randomized controlled trial of an aerobic exercise intervention for older adults at increased risk of dementia

Renata L. Krüger, Cameron M. Clark, Adrienna M. Dyck, Todd J. Anderson, Fiona Clement, Patrick J. Hanly, Heather M. Hanson, Michael D. Hill, David B. Hogan, Jayna Holroyd-Leduc, R. Stewart Longman, Meghan McDonough, G. Bruce Pike, Jean M. Rawling, Tolulope Sajobi, Marc J. Poulin

Evaluating the clinical utility of early exome sequencing in diverse pediatric outpatient populations in the North Carolina Clinical Genomic Evaluation of Next-generation Exome Sequencing (NCGENES) 2 study: a randomized controlled trial

Brooke S. Staley, Laura V. Milko, Margaret Waltz, Ida Griesemer, Lonna Mollison, Tracey L. Grant, Laura Farnan, Myra Roche, Angelo Navas, Alexandra Lightfoot, Ann Katherine M. Foreman, Julianne M. O’Daniel, Suzanne C. O’Neill, Feng-Chang Lin, Tamara S. Roman, Alicia Brandt, Bradford C. Powell, Christine Rini, Jonathan S. Berg, Jeannette T. Bensen

Recruitment and retention rates in randomised controlled trials of exercise therapy in people with multimorbidity: a systematic review and meta-analysis

Lasse K. Harris, Søren T. Skou, Carsten B. Juhl, Madalina Jäger, Alessio Bricca

Can patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design

Indrani S. Bhattacharya, Joanne S. Haviland, Lesley Turner, Hilary Stobart, Ada Balasopoulou, Liba Stones, Anna M. Kirby, Cliona C. Kirwan, Charlotte E. Coles, Judith M. Bliss

Effects of seated lumbar rotation manipulation in treating degenerative lumbar instability: a protocol for a randomized controlled trial

Rui Xie, Long Liang, Kaiming Li, Jie Yu, Minshan Feng, Jiawen Zhan, Xu Wei, Kexin Yang, Zhefeng Jin, He Yin, Xin Chen, Xunlu Yin, Zhiwei Liu, Wenkang Dai, Liguo Zhu

The cerebral mechanism underlying the acupoints with specific effect for gallbladder stone disease: protocol for a randomized controlled task-fMRI trial

Ning Sun, Yuan-Fang Zhou, Jie Zhou, Wen-Wei Zuo, Xiang-Yin Ye, Xiao-Dong Deng, Zheng-Jie Li, Shi-Rui Cheng, Yu-Zhu Qu, Jun Zhou, Rui-Rui Sun, Fan-Rong Liang

An innovative training based on robotics for older people with subacute stroke: study protocol for a randomized controlled trial

Elvira Maranesi, Roberta Bevilacqua, Mirko Di Rosa, Giuseppe Pelliccioni, Valentina Di Donna, Riccardo Luzi, Micaela Morettini, Agnese Sbrollini, Elisa Casoni, Nadia Rinaldi, Renato Baldoni, Fabrizia Lattanzio, Laura Burattini, Giovanni R. Riccardi

Effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia: study protocol for a cluster randomised controlled trial (GAIN)

Olga A. Klein, Melanie Boekholt, Dilshad Afrin, Christina Dornquast, Adina Dreier-Wolfgramm, Armin Keller, Bernhard Michalowsky, Ina Zwingmann, Stefan Teipel, Jochen René Thyrian, Ingo Kilimann, Wolfgang Hoffmann

Recruiting hard-to-reach pregnant women at high psychosocial risk: strategies and costs from a randomised controlled trial

Alice MacLachlan, Karen Crawford, Shona Shinwell, Catherine Nixon, Marion Henderson

A community-based service enhancement model of training and employing Ear Health Facilitators to address the crisis in ear and hearing health of Aboriginal children in the Northern Territory, the Hearing for Learning Initiative (the HfLI): study protocol for a stepped-wedge cluster randomised trial

Kelvin Kong, Alan Cass, Amanda Jane Leach, Peter Stanley Morris, Amy Kimber, Jiunn-Yih Su, Victor Maduabuchi Oguoma

IMI2-PainCare-BioPain-RCT3: 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 electroencephalography (EEG)

André Mouraux, Petra Bloms-Funke, Irmgard Boesl, Ombretta Caspani, Sonya C. Chapman, Giulia Di Stefano, Nanna Brix Finnerup, Luis Garcia-Larrea, Marcus Goetz, Anna Kostenko, Bernhard Pelz, Esther Pogatzki-Zahn, Karin Schubart, Alexandre Stouffs, Andrea Truini, Irene Tracey, Iñaki F. Troconiz, Johannes Van Niel, Jose Miguel Vela, Katy Vincent, Jan Vollert, Vishvarani Wanigasekera, Matthias Wittayer, Keith G. Phillips, Rolf-Detlef Treede

Effect of Baduanjin exercise intervention on cognitive function and quality of life in women with breast cancer receiving chemotherapy: study protocol of a randomized controlled trial

Xiao-Lin Wei, Ru-Zhen Yuan, Yong-Mei Jin, Shu Li, Ming-Yue Wang, Jie-Ting Jiang, Cai-Qin Wu, Kun-Peng Li

Using adalimumab serum concentration to choose a subsequent biological DMARD in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): study protocol for a fully blinded randomised superiority test-treatment trial

Maike H. M. Wientjes, Sadaf Atiqi, Gerrit Jan Wolbink, Michael T. Nurmohamed, Maarten Boers, Theo Rispens, Annick de Vries, Ronald F. van Vollenhoven, Bart J. F. van den Bemt, Alfons A. den Broeder

Correction to: Is postoperative non-weight-bearing necessary? INWN Study protocol for a pragmatic randomised multicentre trial of operatively treated ankle fracture

Ramy Khojaly, Ruairí Mac Niocaill, Muhammad Shahab, Matthew Nagle, Colm Taylor, Fiachra E. Rowan, May Cleary

The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation

Karin Gallandat, Aurélie Jeandron, Ian Ross, Jaime Mufitini Saidi, Baron Bashige Rumedeka, Vercus Lumami Kapepula, Simon Cousens, Elizabeth Allen, Amy MacDougall, Oliver Cumming

Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Lena Violetta Krämer, Nadine Eschrig, Lena Keinhorst, Luisa Schöchlin, Lisa Stephan, Malin Stiene, Jürgen Bengel

Methods for conducting international Delphi surveys to optimise global participation in core outcome set development: a case study in gastric cancer informed by a comprehensive literature review

Bilal Alkhaffaf, Jane M. Blazeby, Aleksandra Metryka, Anne-Marie Glenny, Ademola Adeyeye, Paulo Matos Costa, Ismael Diez del Val, Suzanne S. Gisbertz, Ali Guner, Simon Law, Hyuk-Joon Lee, Ziyu Li, Koji Nakada, Rafael Mauricio Restrepo Nuñez, Daniel Reim, John V. Reynolds, Peter Vorwald, Daniela Zanotti, William Allum, M. Asif Chaudry, Ewen Griffiths, Paula R. Williamson, Iain A. Bruce, Shuangxi Li, Yu-long He, Zekuan Xu, Yingwei Xue, Han Liang, Guoxin Li, Enhao Zhao, Philipp Neumann, Linda O’Neill, Emer Guinan, Gian Luca Baiocchi, Giovanni de Manzoni, Eliza R. C. Hagens, Mark I. van Berge Henegouwen, Patrícia Lages, Susana Onofre, Gabriel Salcedo Cabañas, Maria Posada Gonzalez, Cristina Marin Campos, Bahar Candas, Bahadır Emre Baki, Muhammed Selim Bodur, Reyyan Yildirim, Arif Burak Cekic, Jean-Baptiste Beuscart, Sophie Horbach, Christopher Mecoli, Toby O. Smith

SUMMER Trial: mesh versus suture repair in small umbilical hernias in adults—a study protocol for a prospective randomized double-blind multicenter clinical trial

M. Melkemichel, S. Bringman, G. Granåsen, B. Widhe

A prospective, randomized, single-blinded, crossover trial to investigate the effect of a wearable device in addition to a daily symptom diary for the remote early detection of SARS-CoV-2 infections (COVID-RED): a structured summary of a study protocol for a randomized controlled trial

Timo B. Brakenhoff, Billy Franks, Brianna Mae Goodale, Janneke van de Wijgert, Santiago Montes, Duco Veen, Eskild K. Fredslund, Theo Rispens, Lorenz Risch, Ariel V. Dowling, Amos A. Folarin, Patricia Bruijning, Richard Dobson, Tessa Heikamp, Paul Klaver, Maureen Cronin, Diederick E. Grobbee, Spiros Denaxas, Johannes B. Reitsma, Christian Simon, Alison Kuchta, Pieter Stolk, George Downward, René van Lier, Jakob Kjellberg, Martin Risch, Kirsten Grossmann, David Conen, Stefanie Aeschbacher

The effect of the mobile “blood pressure management application” on hypertension self-management enhancement: a randomized controlled trial

Ali Bozorgi, Hamed Hosseini, Hassan Eftekhar, Reza Majdzadeh, Ali Yoonessi, Ali Ramezankhani, Mehdi Mansouri, Mahnaz Ashoorkhani

Standard induction with basiliximab versus no induction in low immunological risk kidney transplant recipients: study protocol for a randomized controlled trial

Aziza Ajlan, Hassan Aleid, Tariq Zulfiquar Ali, Hala Joharji, Khalid Almeshari, Ahmed Mohammed Nazmi, Yaser Shah, Edward Devol, Dalal Alkortas, Zinah Alabdulkarim, Dieter Broering, Ibrahim Alahmadi, Asad Ullah, Anwar Alotaibi, Ahmed Aljedai

The development of lived experience-centered word clouds to support research uncertainty gathering in degenerative cervical myelopathy: results from an engagement process and protocol for their evaluation, via a nested randomized controlled trial

Benjamin M. Davies, Oliver D. Mowforth, Danyal Z. Khan, Xiaoyu Yang, Sybil R. L. Stacpoole, Olesja Hazenbiller, Toto Gronlund, Lindsay Tetreault, Sukhvinder Kalsi-Ryan, Michelle L. Starkey, Iwan Sadler, Ellen Sarewitz, Delphine Houlton, Julia Carter, Evangeline Howard, Vafa Rahimi-Movaghar, James D. Guest, Bizhan Aarabi, Brian K. Kwon, Shekar N. Kurpad, James Harrop, Jefferson R. Wilson, Robert Grossman, Emma K. Smith, Angus G.K. McNair, Michael G. Fehlings, Mark R. N. Kotter

The Retornus-2 study: impact of respiratory muscle training in subacute stroke patients with dysphagia, study protocol of a double-blind randomized controlled trial

A. Guillen-Sola, M. Messaggi-Sartor, C. Ramírez-Fuentes, E. Marco, E. Duarte

Recommendations for designing and analysing multi-arm non-inferiority trials: a review of methodology and current practice

Jake Emmerson, Susan Todd, Julia M. Brown

Public access to protocols of contemporary cancer randomized clinical trials

Christopher Babu, Loren Mell, Nancy Lee, Kaveh Zakeri

Improving analysis practice of continuous adverse event outcomes in randomised controlled trials - a distributional approach

Anca Chis Ster, Rachel Phillips, Odile Sauzet, Victoria Cornelius

Survival analysis for AdVerse events with VarYing follow-up times (SAVVY)—estimation of adverse event risks

Regina Stegherr, Claudia Schmoor, Jan Beyersmann, Kaspar Rufibach, Valentine Jehl, Andreas Brückner, Lewin Eisele, Thomas Künzel, Katrin Kupas, Frank Langer, Friedhelm Leverkus, Anja Loos, Christiane Norenberg, Florian Voss, Tim Friede

Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial

Chun Yang, Xianjian Huang, Junfeng Feng, Li Xie, Jiyuan Hui, Weiping Li, Jiyao Jiang

Cost talk: protocol for a stepped-wedge cluster randomized trial of an intervention helping patients and urologic surgeons discuss costs of care for slow-growing prostate cancer during shared decision-making

Mary C. Politi, Rachel C. Forcino, Katelyn Parrish, Marie-Anne Durand, A. James O’Malley, Glyn Elwyn

The role of routine FIBERoptic bronchoscopy monitoring during percutaneous dilatational TRACHeostomy (FIBERTRACH): a study protocol for a randomized, controlled clinical trial

José M. Añón, María Soledad Arellano, Manuel Pérez-Márquez, Claudia Díaz-Alvariño, José A. Márquez-Alonso, Jorge Rodríguez-Peláez, Kapil Nanwani-Nanwani, Ana Martín-Pellicer, Belén Civantos, Alba López-Fernández, Irene Seises, Jorge García-Nerín, Juan C. Figueira, Henar Casero, Javier Vejo, Alexander Agrifoglio, Lucía Cachafeiro, Mariana Díaz-Almirón, Jesús Villar

Bilateral cervical plexus block for anterior cervical spine surgery: study protocol for a randomised placebo-controlled trial

Michael J. Mulcahy, Thananchayan Elalingam, Kevin Jang, Mario D’Souza, Matthew Tait

Stereotactic EEG-guided radiofrequency thermocoagulation versus anterior temporal lobectomy for mesial temporal lobe epilepsy with hippocampal sclerosis: study protocol for a randomised controlled trial

Yi-He Wang, Si-Chang Chen, Peng-Hu Wei, Kun Yang, Xiao-Tong Fan, Fei Meng, Jia-Lin Du, Lian-Kun Ren, Yong-Zhi Shan, Guo-Guang Zhao

Efficacy and mechanism of traditional Chinese medicine in relieving antibiotic-resistant bacterial diarrhea in children: study protocol for a randomized controlled trial

Chao-ran Bi, Wei Jing, Xiao-fei Xie, Yan-jing Liu

0.9% Sodium chloride solution versus Plasma-Lyte 148 versus compound sodium lacTate solution in children admitted to PICU—a randomized controlled trial (SPLYT-P): study protocol for an intravenous fluid therapy trial

Sainath Raman, Andreas Schibler, Renate Le Marsney, Peter Trnka, Melanie Kennedy, Adrian Mattke, Kristen Gibbons, Luregn J. Schlapbach

SAVER: sodium valproate for the epigenetic reprogramming of high-risk oral epithelial dysplasia—a phase II randomised control trial study protocol

Caroline McCarthy, Joseph Sacco, Stefano Fedele, Michael Ho, Stephen Porter, Triantafillos Liloglou, Bill Greenhalf, Max Robinson, Bridget Young, Silvia Cicconi, Seema Chauhan, Binyam Tesfaye, Richard Jackson, Frances Sherratt, Richard Shaw

Using routinely recorded data in a UK RCT: a comparison to standard prospective data collection methods

G. A. Powell, L. J. Bonnett, C. T. Smith, D. A. Hughes, P. R. Williamson, A. G. Marson

SENSory re-learning of the UPPer limb (SENSUPP) after stroke: development and description of a novel intervention using the TIDieR checklist

Håkan Carlsson, Birgitta Rosén, Anders Björkman, Hélène Pessah-Rasmussen, Christina Brogårdh

Hormonal intervention for the treatment of veterans with COVID-19 requiring hospitalization (HITCH): a multicenter, phase 2 randomized controlled trial of best supportive care vs best supportive care plus degarelix: study protocol for a randomized controlled trial

Nicholas G. Nickols, Matthew B. Goetz, Christopher J. Graber, Debika Bhattacharya, Guy Soo Hoo, Matthew Might, David B. Goldstein, Xinchen Wang, Rachel Ramoni, Kenute Myrie, Samantha Tran, Leila Ghayouri, Sonny Tsai, Michelle Geelhoed, Danil Makarov, Daniel J. Becker, Jun-Chieh Tsay, Melissa Diamond, Asha George, Mohammad Al-Ajam, Pooja Belligund, R. Bruce Montgomery, Elahe A. Mostaghel, Carlie Sulpizio, Zhibao Mi, Ellen Dematt, Joseph Tadalan, Leslie E. Norman, Daniel Briones, Christina E. Clise, Zachary W. Taylor, Jeffrey R. Huminik, Kousick Biswas, Matthew B. Rettig

Correction to: Effectiveness of a digitally supported care management programme to reduce unmet needs of family caregivers of people with dementia: study protocol for a cluster randomised controlled trial (GAIN)

Olga A. Klein, Melanie Boekholt, Dilshad Afrin, Christina Dornquast, Adina Dreier-Wolfgramm, Armin Keller, Bernhard Michalowsky, Ina Zwingmann, Stefan Teipel, Jochen René Thyrian, Ingo Kilimann, Wolfgang Hoffmann

TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis

M. Cole, C. Yap, C. Buckley, W. F. Ng, I. McInnes, A. Filer, S. Siebert, A. Pratt, J. D. Isaacs, D. D. Stocken

Effect of curcumin-pipeine supplementation on clinical status, mortality rate, oxidative stress, and inflammatory markers in critically ill ICU patients with COVID-19: a structured summary of a study protocol for a randomized controlled trial

Gholamreza Askari, Babak Alikiaii, Davood Soleimani, Amirhossein Sahebkar, Mahdiye Mirjalili, Awat Feizi, Bijan Iraj, Mohammad Bagherniya

Evaluation of the efficacy and safety of recombinant erythropoietin on the improvement of hospitalised COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial

Hamid Reza Samimagham, Mehdi Hassani Azad, Dariush Hooshyar, Maryam Haddad, Mohsen Arabi, Mitra KazemiJahromi

Efficacy of i-PRF in regenerative endodontics therapy for mature permanent teeth with pulp necrosis: study protocol for a multicentre randomised controlled trial

Yuee Liang, Rongyang Ma, Lijuan Chen, Xingzhu Dai, Shiya Zuo, Weiyi Jiang, Naiming Hu, Zilong Deng, Wanghong Zhao

Effects of traditional Chinese medicine combined with chemotherapy for extensive-stage small-cell lung cancer patients on improving oncologic survival: study protocol of a multicenter, randomized, single-blind, placebo-controlled trial

Yuyi Chen, Mingwei Yu, Zishen Liu, Yi Zhang, Qiwei Li, Guowang Yang

Lowering blood pressure by changing lifestyle through a motivational education program: a cluster randomized controlled trial study protocol

Fakir M Amirul Islam, Elisabeth A. Lambert, Sheikh Mohammed Shariful Islam, M. Ariful Islam, Dip Biswas, Rachael McDonald, Ralph Maddison, Bruce Thompson, Gavin W. Lambert

Effectiveness of self-administered mirror therapy on upper extremity impairments and function of acute stroke patients: study protocol

Venkadesan Rajendran, Deepa Jeevanantham, Céline Larivière, Ravinder-Jeet Singh, Lisa Zeman, Padma Papuri

Responding to COVID-19 threats to trial conduct: lessons learned from a feasibility trial of a psychological intervention for South African adolescents

Bronwyn Myers, Claire van der Westhuizen, Megan Pool, Nancy Hornsby, Katherine R. Sorsdahl

Principles for the production and dissemination of recruitment material for three clinical trials of an online intervention

Stefan Rennick-Egglestone

A randomised controlled unblinded multicentre non-inferiority trial with activated vitamin D and prednisolone treatment in patients with minimal change nephropathy (ADAPTinMCN)

Tilde Kristensen, Henrik Birn, Per Ivarsen

Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

Nathan A. Pearson, Elizabeth Tutton, Alexander Joeris, Stephen Gwilym, Richard Grant, David J. Keene, Kirstie L. Haywood

Listening to Mom in the NICU: effects of increased maternal speech exposure on language outcomes and white matter development in infants born very preterm

Edith Brignoni-Pérez, Maya Chan Morales, Virginia A. Marchman, Melissa Scala, Heidi M. Feldman, Kristen Yeom, Katherine E. Travis

Telerehabilitation program for older adults on a waiting list for physical therapy after hospital discharge: study protocol for a pragmatic randomized trial protocol

Pollyana Ruggio Tristão Borges, Renan Alves Resende, Jane Fonseca Dias, Marisa Cotta Mancini, Rosana Ferreira Sampaio

The effectiveness of a psycho-education intervention on mental health literacy in communities affected by the COVID-19 pandemic—a cluster randomized trial of 24 villages in central Uganda—a research protocol

Dickens Akena, Ronald Kiguba, Wilson W. Muhwezi, Brendan Kwesiga, Gwendolyne Kigozi, Noeline Nakasujja, Hafsa Lukwata

Process evaluation of the Bridging the Age Gap in Breast Cancer decision support intervention cluster randomised trial

Maria Burton, Kate J. Lifford, Lynda Wyld, Fiona Armitage, Alistair Ring, Anthony Nettleship, Karen Collins, Jenna Morgan, Malcolm W. R. Reed, Geoffrey R. Holmes, Mike Bradburn, Jacqui Gath, Tracy Green, Deirdre Revell, Kate Brain, Adrian Edwards, Helena Harder, Susan Ward, Paul Richards, Charlene Martin, Tim Chater, Kirsty Pemberton, Christopher Murray, Stephen Walters, Esther Herbert, Thompson Robinson, Kwok Leung Cheung, Riccardo Audisio

A randomized clinical trial to assess the effectiveness of pre- and post-surgical pelvic floor physiotherapy for bowel symptoms, pelvic floor function, and quality of life of patients with rectal cancer: CARRET protocol

Cinara Sacomori, Luz Alejandra Lorca, Mónica Martinez-Mardones, Roberto Ignacio Salas-Ocaranza, Guillermo Patricio Reyes-Reyes, Marta Natalia Pizarro-Hinojosa, Jorge Plasser-Troncoso

Protocol for a process evaluation of an external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care: the PolyPrime study

Audrey Rankin, Gerard J. Molloy, Cathal A. Cadogan, Heather E. Barry, Ashleigh Gorman, Cristín Ryan, Alan Ferrett, Pat McCarthy, Gerard J. Gormley, Tom Fahey, Carmel M. Hughes

Intradermal acupuncture for rheumatoid arthritis: study protocol for a randomised controlled trial

Huifang Luo, Jie Peng, Qing Ma, Zhihua Wei, Changsong Lin, Mingying Zhang, Peiwu Li, Yang Song, Xiangwei Yang

A randomized open-label trial to evaluate the efficacy and safety of triple therapy with aspirin, atorvastatin, and nicorandil in hospitalised patients with SARS Cov-2 infection: A structured summary of a study protocol for a randomized controlled trial

Ambudhar Sharma, Charu Sharma, Sujeet Raina, Balraj Singh, Devendra Singh Dadhwal, Vinay Dogra, Swatantra Gupta, Shyam Bhandari, Vivek Sood

An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: a study protocol for the SITA (Should I Take Aspirin?) trial

Shakira Milton, Jennifer McIntosh, Finlay Macrae, Patty Chondros, Lyndal Trevena, Mark Jenkins, Fiona M. Walter, Natalie Taylor, Lucy Boyd, Sibel Saya, Napin Karnchanachari, Kitty Novy, Carmody Forbes, Javiera Martinez Gutierrez, Kate Broun, Sara Whitburn, Sarah McGill, George Fishman, Julie Marker, Max Shub, Jon Emery

An individual randomised efficacy trial of autologous blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in leprosy in Nepal: the TABLE trial protocol

Indra B. Napit, Dilip Shrestha, Jon Bishop, Sopna Choudhury, Santosh Dulal, Paramjit Gill, Eleni Gkini, Holly Gwyther, Deanna A. Hagge, Karuna Neupane, Jo Sartori, Gemma Slinn, Samuel I. Watson, Richard Lilford

Differences in the individual curative effect of acupuncture for obese women with polycystic ovary syndrome based on metagenomic analysis: study protocol for a randomized controlled trial

Huaying Fan, Xiaojuan Hong, Jiuzhi Zeng, Xue Wang, Jiao Chen

Intensive group-based cognitive therapy in patients with cardiac disease and psychological distress—a randomized controlled trial protocol

Annette Holdgaard, Christine Eckhardt-Hansen, Thomas Lund, Christina Funch Lassen, Kirstine Lærum Sibiliz, Dan Eik Høfsten, Eva Prescott, Hanne Kruuse Rasmusen

An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial

Markus Harboe Olsen, Britt Morthorst, Anne Katrine Pagsberg, Michella Heinrichsen, Bo Møhl, Lotte Rubæk, Johan Bjureberg, Olivia Simonsson, Jane Lindschou, Christian Gluud, Janus Christian Jakobsen

Moderate-intensity exercise versus high-intensity interval training to recover walking post-stroke: protocol for a randomized controlled trial

Allison Miller, Darcy S. Reisman, Sandra A. Billinger, Kari Dunning, Sarah Doren, Jaimie Ward, Henry Wright, Erin Wagner, Daniel Carl, Myron Gerson, Oluwole Awosika, Jane Khoury, Brett Kissela, Pierce Boyne

Stakeholder perspectives on barriers and enablers to recruiting anxious children undergoing day surgery under general anaesthetic: a qualitative internal pilot study of the MAGIC randomised controlled trial

Jennifer Kettle, Chris Deery, Robert Bolt, Diana Papaioannou, Zoe Marshman

Adapting to the COVID-19 pandemic on Building Research in Diet and Cognition (BRIDGE) trial

Marian Fitzgibbon, Lara Blumstein, Linda Schiffer, Mirjana A. Antonic, Andrew McLeod, Roxanne Dakers, Leo Restrepo, Elizabeth A. Boots, Jennifer C. Sanchez-Flack, Lisa Tussing-Humphreys, Melissa Lamar

Can bag-valve mask ventilation with positive end-expiratory pressure reduce hypoxia during intubation? A prospective, randomized, double-blind trial

Yili Dai, Jiayuan Dai, Joseph Harold Walline, Yangyang Fu, Huadong Zhu, Jun Xu, Xuezhong Yu

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

Arabella Scantlebury, Catriona McDaid, Stephen Brealey, Elizabeth Cook, Hemant Sharma, Arun Ranganathan, Joy Adamson

Angiotensin-converting enzyme inhibitor for post-transcatheter aortic valve implantation patients: study protocol for a multicenter randomized, open-label blinded endpoint control trial

Yan Biao Liao, Congying Xia, Yiheng Cheng, Qiao Li, Xin Wei, Yuanweixiang Ou, Fei Chen, Yijian Li, Qi Liu, Tianyuan Xiong, Zhengang Zhao, Yong Peng, Jiafu Wei, Yuan Feng, Mao Chen

Effects of lower extremity constraint-induced movement therapy on gait and balance of chronic hemiparetic patients after stroke: description of a study protocol for a randomized controlled clinical trial

Elaine Menezes-Oliveira, Gabriela da Silva Matuti, Clarissa Barros de Oliveira, Simone Ferreira de Freitas, Catia Miyuki Kawamura, José Augusto Fernandes Lopes, Ricardo Mario Arida

Does intervention with GLP-1 receptor agonist semaglutide modulate perception of sweet taste in women with obesity: study protocol of a randomized, single-blinded, placebo-controlled clinical trial

Mojca Jensterle, Simona Ferjan, Tadej Battelino, Jernej Kovač, Saba Battelino, Dušan Šuput, Andrej Vovk, Andrej Janež

The use of electronic health records for recruitment in clinical trials: a mixed methods analysis of the Harmony Outcomes Electronic Health Record Ancillary Study

Emily C. O’Brien, Sudha R. Raman, Alicia Ellis, Bradley G. Hammill, Lisa G. Berdan, Tyrus Rorick, Salim Janmohamed, Zachary Lampron, Adrian F. Hernandez, Lesley H. Curtis

Efficacy and safety of Suxiao Jiuxin Pill in the treatment of stable angina (Qi stagnation and blood stasis syndrome): study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial

Xiaofen Ruan, Yiping Li, Yuanlong Sun, Meijun Jia, Xiaowen Xu, Li Huo, Wei Song, Yili Yao, Xiaolong Wang

Statistical analysis plan for a pragmatic phase III randomised controlled trial examining behaviour change physiotherapy intervention to increase physical activity following hip and knee replacements: the PEP-TALK trial

Alexander Ooms, Susan J. Dutton, Scott Parsons, Beth Fordham, Caroline Hing, Sarah Lamb, Toby Smith

Effectiveness of the Elos 2.0 prevention programme for the reduction of problem behaviours and promotion of social skills in schoolchildren: study protocol for a cluster-randomized controlled trial

Marília Mariano, Anderson Ribeiro da Silva, Jacqueline L. S. Lima, Nícolas Tenedine de Pinho, Hugo Cogo-Moreira, Márcia H. S. Melo, Jair J. Mari, Zila M. Sanchez, Sheila C. Caetano

Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial

Kristin Helene Skullerud, Petter Gjersvik, Are Hugo Pripp, Erik Qvigstad, Anne Lise Ording Helgesen

Effects of variable frequencies of kinesthesia, balance and agility exercise program in adults with knee osteoarthritis: study protocol for a randomized controlled trial

Aysha I. Adhama, Mukadas O. Akindele, Aminu A. Ibrahim

Feasibility and diagnostic accuracy of Telephone Administration of an adapted wound heaLing QuestiONnaire for assessment for surgical site infection following abdominal surgery in low and middle-income countries (TALON): protocol for a study within a trial (SWAT)

James Glasbey, Victoria Adeyeye, Adesoji Ademuyiwa, Alisha Bhatt, Bruce Biccard, Jane Blazeby, Peter Brocklehurst, Sohini Chakrabortee, Jean De La Croix Allen Ingabire, Francis Moïse Dossou, Irani Durán, Rohini Dutta, Dhruv Ghosh, Frank Gyamfi, Parvez Haque, Pollyanna Hardy, Gabriella Hyman, Ritu Jain, Oluwaseun Ladipo-Ajayi, Ismail Lawani, Souliath Lawani, Mwayi Kachapila, Karolin Kroese, Rachel Lillywhite, Rhiannon Macefield, Laura Magill, Janet Martin, Jonathan Mathers, Punam Mistry, Rohin Mittal, Mark Monahan, Rachel Moore, Dion Morton, Faustin Ntirenganya, Emmanuel Ofori, Rupert Pearse, Alberto Peón, Thomas Pinkney, Antonio Ramos de la Medina, Tubasiime Ronald, David Roman, Anita Slade, Stephen Tabiri, Donna Smith, Aneel Bhangu

Trends in clinical trial registration in sub-Saharan Africa between 2010 and 2020: a cross-sectional review of three clinical trial registries

Bassey Edem, Chukwuemeka Onwuchekwa, Oghenebrume Wariri, Esin Nkereuwem, Oluwatosin O. Nkereuwem, Victor Williams

Preservation of the ovarian reserve and hemostasis during laparoscopic ovarian cystectomy by a hemostatic agent versus suturing for patients with ovarian endometriosis: study protocol for randomized controlled, non-inferiority trial (PRAHA-2 trial)

Hyunji Lim, Soo Jin Park, Haerin Paik, Jaehee Mun, Eun Ji Lee, Seungmee Lee, Whasun Lim, Gwonhwa Song, Seung-Hyuk Shim, Chae Hyeong Lee, Ga Won Yim, Hee Seung Kim

Community-based intervention for prevention and management of chronic obstructive pulmonary disease in Nepal (COBIN-P trial): study protocol for a cluster-randomized controlled trial

Tara Ballav Adhikari, Dinesh Neupane, Arjun Karki, Arne Drews, Brendan Cooper, Marieann Högman, Torben Sigsgaard, Per Kallestrup

Prophylactic nimodipine treatment for hearing preservation after vestibular schwannoma surgery: study protocol of a randomized multi-center phase III trial—AkniPro 2

Christian Scheller, Christian Strauss, Sandra Leisz, Pia Hänel, Ariane Klemm, Simone Kowoll, Iris Böselt, Torsten Rahne, Andreas Wienke

Baidu Jieduan granules, traditional Chinese medicine, in the treatment of moderate coronavirus disease-2019 (COVID-19): study protocol for an open-label, randomized controlled clinical trial

Wen Zhang, Qin Xie, Xiaoming Xu, Shuting Sun, Tian Fan, Xinxin Wu, Yao Qu, Jinhua Che, Tingrong Huang, Huacheng Li, You Zheng, Chao Jiang, Bangjiang Fang, Shuang Zhou

Effects of real-time feedback during decline walking on kinematic and kinetic gait parameters in a healthy population: study protocol for a randomized trial — up and down

Klaus Widhalm, Sebastian Durstberger, Peter Putz

Advancing collaborations in health research and clinical trials in Sub-Saharan Africa: development and implementation of a biostatistical collaboration module in the Masters in Biostatistics Program at Stellenbosch University

Tonya M. Esterhuizen, Guowei Li, Taryn Young, Jie Zeng, Rhoderick Machekano, Lehana Thabane

Tonsillectomy versus tonsillotomy for recurrent acute tonsillitis in children and adults (TOTO): study protocol for a randomized non-inferiority trial

Orlando Guntinas-Lichius, Katharina Geißler, Thomas Asendorf, Ralf Tostmann, Jan Löhler

The Core Outcome DEvelopment for Carrier Screening (CODECS) study: protocol for development of a core outcome set

Ebony Richardson, Alison McEwen, Toby Newton-John, Karine Manera, Chris Jacobs

Effect of opposing needling on motor cortex excitability in healthy participants and in patients with post-stroke hemiplegia: study protocol for a single-blind, randomised controlled trial

Mindong Xu, Yinyu Zi, Jianlu Wu, Nenggui Xu, Liming Lu, Jiahui Liu, Yanling Yu, Haofeng Mo, Weifeng Wen, Xiaorong Tang, Wenjuan Fan, Yu Zhang, Churong Liu, Wei Yi, Lin Wang

A cultural experience to support mental health in people aged 16–24 during the COVID-19 pandemic compared to a typical museum website: study protocol of an online randomised controlled trial

Rebecca J. Syed Sheriff, Matti Vuorre, Evgenia Riga, Andrew K. Przybylski, Helen Adams, Catherine J. Harmer, John R. Geddes

Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial

Na Nie, Le Chen, Tong Li, Chuanlong Zhou, Bangwei Li, Conghua Ji, Jie Zhou, Qin Chen, Qiushuang Li, Yi Liang, Jianqiao Fang

Effects of voluntary pre-contraction of the pelvic floor muscles (the Knack) on female stress urinary incontinence—a study protocol for a RCT

Fátima Faní Fitz, Márcia Maria Gimenez, Letícia de Azevedo Ferreira, Mayanni Magda Perreira Matias, Maria Augusta Tezelli Bortolini, Rodrigo Aquino Castro

Efficacy and safety of electroacupuncture combined with Suanzaoren decoction for insomnia following stroke: study protocol for a randomized controlled trial

Hui-lian Huang, Song-bai Yang, Zhi-gang Mei, Ya-guang Huang, Mao-hua Chen, Qun-li Mei, Hua-ping Lei, Qing-xian Mei, Jian-hua Chen

Rationale and study design of an early care, therapeutic education, and psychological intervention program for the management of post-intensive care syndrome and chronic pain after COVID-19 infection (PAIN-COVID): study protocol for a randomized controlled trial

Antonio Ojeda, Andrea Calvo, Tomas Cuñat, Ricard Mellado Artigas, Oscar Comino-Trinidad, Jorge Aliaga, Marilyn Arias, Maribel Ahuir, Carlos Ferrando, Christian Dürsteler

AGILE: a seamless phase I/IIa platform for the rapid evaluation of candidates for COVID-19 treatment: an update to the structured summary of a study protocol for a randomised platform trial letter

Gareth O. Griffiths, Richard FitzGerald, Thomas Jaki, Andrea Corkhill, Helen Reynolds, Sean Ewings, Susannah Condie, Emma Tilt, Lucy Johnson, Mike Radford, Catherine Simpson, Geoffrey Saunders, Sara Yeats, Pavel Mozgunov, Olana Tansley-Hancock, Karen Martin, Nichola Downs, Izabela Eberhart, Jonathan W. B. Martin, Cristiana Goncalves, Anna Song, Tom Fletcher, Kelly Byrne, David G. Lalloo, Andrew Owen, Michael Jacobs, Lauren Walker, Rebecca Lyon, Christie Woods, Jennifer Gibney, Justin Chiong, Nomathemba Chandiwana, Shevin Jacob, Mohammed Lamorde, Catherine Orrell, Munir Pirmohamed, Saye Khoo

Impact of a “vegetables first” approach to complementary feeding on later intake and liking of vegetables in infants: a study protocol for a randomised controlled trial

Jeanette P. Rapson, Pamela R. von Hurst, Marion M. Hetherington, Cathryn A. Conlon

The Community PrEP Study: a randomized control trial leveraging community-based platforms to improve access and adherence to pre-exposure prophylaxis to prevent HIV among adolescent girls and young women in South Africa—study protocol

Andrew Medina-Marino, Dana Bezuidenhout, Sybil Hosek, Ruanne V. Barnabas, Millicent Atujuna, Charl Bezuidenhout, Phuti Ngwepe, Remco P.H. Peters, Francesca Little, Connie L. Celum, Joseph Daniels, Linda-Gail Bekker

Study protocol for a randomized controlled trial to improve the quality of life of housewives with musculoskeletal disorders: a health promotion intervention based on a participatory ergonomic approach—the Housewives Ergonomic Intervention (HEI) trial

Samaneh Norouzi, Sedigheh Sadat Tavafian, Rosanna Cousins, Hamidreza Mokarami

The Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome (CHAIRS): a study protocol for a double-blinded randomized controlled trial

Xiaohui Guo, Meiling Xuan, Huan Zheng, Shumin Qin, Haomeng Wu, Shaogang Huang, Zehuai Wen

Effects of early respiratory physiotherapy on spontaneous respiratory activity of preterm infants: study protocol for a randomized controlled trial

Alessia Di Polito, Arianna Del Vecchio, Milena Tana, Patrizia Papacci, Anna Laura Vento, Benedetta Campagnola, Sefora Celona, Laura Cricenti, Ilaria Bastoni, Chiara Tirone, Alessandra Lio, Claudia Aurilia, Anthea Bottoni, Angela Paladini, Francesco Cota, Paola Emilia Ferrara, Gianpaolo Ronconi, Giovanni Vento

Placebo response and effect in randomized clinical trials: meta-research with focus on contextual effects

Sigurlaug H. Hafliðadóttir, Carsten B. Juhl, Sabrina M. Nielsen, Marius Henriksen, Ian A. Harris, Henning Bliddal, Robin Christensen

Understanding the benefits and burdens associated with a malaria human infection study in Kenya: experiences of study volunteers and other stakeholders

Primus Che Chi, Esther Awuor Owino, Irene Jao, Fredrick Olewe, Bernhards Ogutu, Philip Bejon, Melissa Kapulu, Dorcas Kamuya, Vicki Marsh, Abdirahman I. Abdi, Yonas Abebe, Agnes Audi, Peter Billingsley, Peter C. Bull, Mainga Hamaluba, Zaydah de Laurent, Susanne H. Hodgson, Stephen Hoffman, Eric James, Gathoni Kamuyu, Silvia Kariuki, Nelson Kibinge, Rinter Kimathi, Sam Kinyanjui, Cheryl Kivisi, Nelly Koskei, Mallika Imwong, Brett Lowe, Johnstone Makale, Kevin Marsh, Khadija Said Mohammed, Moses Mosobo, Sean C. Murphy, Linda Murungi, Jennifer Musyoki, Michelle Muthui, Jedidah Mwacharo, Daniel Mwanga, Joyce Mwongeli, Francis Ndungu, Maureen Njue, Patricia Njuguna, George Nyangweso, Domitila Kimani, Joyce M. Ngoi, Janet Musembi, Omar Ngoto, Edward Otieno, Faith Osier, James Oloo, Donwilliams Omuoyo, John Ongecha, Martin O. Ongas, Michael Ooko, Jimmy Shangala, Betty Kim Lee Sim, Joel Tarning, James Tuju, Juliana Wambua, Thomas N. Williams, Markus Winterberg

The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD)

Moira Kelly, Liz Steed, Ratna Sohanpal, Hilary Pinnock, Amy Barradell, Clarisse Dibao-Dina, Kristie-Marie Mammoliti, Vari Wileman, Vickie Rowland, Sian Newton, Anna Moore, Stephanie Taylor

Microbial Interventions to Control and Reduce Blood Pressure in Australia (MICRoBIA): rationale and design of a double-blinded randomised cross-over placebo controlled trial

Dakota Rhys-Jones, Rachel E. Climie, Paul A. Gill, Hamdi A. Jama, Geoffrey A. Head, Peter R. Gibson, David M. Kaye, Jane G. Muir, Francine Z. Marques

Detailed statistical analysis plan for the short-term versus long-term mentalisation-based therapy for outpatients with subthreshold or diagnosed borderline personality disorder randomised clinical trial (MBT-RCT)

Sophie Juul, Sebastian Simonsen, Stig Poulsen, Susanne Lunn, Per Sørensen, Anthony Bateman, Janus Christian Jakobsen

Effect of GreenshellTM mussel on osteoarthritis biomarkers and inflammation in healthy postmenopausal women: a study protocol for a randomized double-blind placebo-controlled trial

Maryam Abshirini, Jane Coad, Frances M. Wolber, Pamela von Hurst, Matthew R. Miller, Hong Sabrina Tian, Marlena C. Kruger

Patient and public involvement in numerical aspects of trials (PoINT): exploring patient and public partners experiences and identifying stakeholder priorities

Beatriz Goulao, Hanne Bruhn, Marion Campbell, Craig Ramsay, Katie Gillies

Resiliency Engagement and Care in Health (REaCH): a telephone befriending intervention for upskilled rural youth in the context of COVID-19 pandemic—study protocol for a multi-centre cluster randomised controlled trial

Saju Madavanakadu Devassy, Komal Preet Allagh, Anuja Maria Benny, Lorane Scaria, Natania Cheguvera, I. P. Sunirose

Educational films for improving screening and self-management of gestational diabetes in India and Uganda (GUIDES): study protocol for a cluster-randomised controlled trial

Laura L. Oakley, Deepa R, Arthur Namara, Biswamitra Sahu, Iliatha Papachristou Nadal, Yamuna Ana, Helen Coombe, Eugene Oteng-Ntim, Janet Seeley, Moffat Nyirenda, Giridhar Babu, Sanjay Kinra

Randomised study within a trial (SWAT) to evaluate personalised versus standard text message prompts for increasing trial participant response to postal questionnaires (PROMPTS)

Lucy Cureton, Ioana R. Marian, Vicki S. Barber, Adwoa Parker, David J. Torgerson, Sally Hopewell

Tapering of prescribed opioids in patients with long-term non-malignant pain (TOPIO)—efficacy and effects on pain, pain cognitions, and quality of life: a study protocol for a randomized controlled clinical trial with a 12-month follow-up

Grelz Henrik, Midlöv Patrik, Håkansson Anders, Jakobsson Ulf, Rivano Fischer Marcelo, Ringqvist Åsa

The efficacy of Tuina with herbal ointment for patients with post-stroke depression: study protocol for a randomized controlled trial

Jiming Tao, Lingjun Kong, Min Fang, Qingguang Zhu, Shuaipan Zhang, Sicong Zhang, Jiajia Wu, Chunlei Shan, Ling Feng, Qingjuan Guo, Zhiwei Wu

COVEPIC (Cognitive and spOrt Virtual EPIC training) investigating the effects of home-based physical exercise and cognitive training on cognitive and physical functions in community-dwelling older adults: study protocol of a randomized single-blinded clinical trial

Emma Gabrielle Dupuy, Florent Besnier, Christine Gagnon, Thomas Vincent, Catherine-Alexandra Grégoire, Caroll-Ann Blanchette, Kathia Saillant, Nadia Bouabdallaoui, Josep Iglesies-Grau, Marie Payer, Marie-France Marin, Sylvie Belleville, Martin Juneau, Paolo Vitali, Mathieu Gayda, Anil Nigam, Louis Bherer

A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial

Jennifer A. Rabbitts, Chuan Zhou, Rocio de la Vega, Homer Aalfs, Caitlin B. Murray, Tonya M. Palermo

Protocol for the development of a Core Outcome Set for trials on the prevention and treatment of Orthodontically induced enamel White Spot Lesions (COS-OWSL)

Danchen Qin, Yunlei Wang, Colin Levey, Peter Ngan, Hong He, Fang Hua

An Investigation of Levetiracetam in Alzheimer’s Disease (ILiAD): a double-blind, placebo-controlled, randomised crossover proof of concept study

Arjune Sen, Mary Akinola, Xin You Tai, Mkael Symmonds, Gabriel Davis Jones, Sergio Mura, Joanne Galloway, Angela Hallam, Jane Y. C. Chan, Ivan Koychev, Chris Butler, John Geddes, Rohan Van Der Putt, Sian Thompson, Sanjay G. Manohar, Eleni Frangou, Sharon Love, Rupert McShane, Masud Husain

Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial

Wolfgang Mitterer, Christoph Binder, Anya Blassnig-Ezeh, Lorenz Auer-Hackenberg, Angelika Berger, Burkhard Simma, Martin Wald, Martin Lee, Ursula Kiechl-Kohlendorfer

‘Relearning how to think’: A brief online intervention to modify biased interpretations in emotional disorders—study protocol for a randomised controlled trial

Inés Nieto, Carmelo Vazquez

REBOARREST, resuscitative endovascular balloon occlusion of the aorta in non-traumatic out-of-hospital cardiac arrest: a study protocol for a randomised, parallel group, clinical multicentre trial

Jostein Rødseth Brede, Arne Kristian Skulberg, Marius Rehn, Kjetil Thorsen, Pål Klepstad, Ida Tylleskär, Bjørn Farbu, Jostein Dale, Trond Nordseth, Rune Wiseth, Andreas Jørstad Krüger

Financial Incentives for Preventing Postpartum return to Smoking (FIPPS): study protocol for a three-arm randomised controlled trial

M. Ussher, C. Best, S. Lewis, J. McKell, T. Coleman, S. Cooper, S. Orton, L. Bauld

Rapid deployment of a community engagement study and educational trial via social media: implementation of the UC-COVID study

Lauren E. Wisk, Russell G. Buhr

Green tea intake and its effect on laboratory parameters and disease symptoms in hospitalised patients with Covid 19: a structured protocol for a randomized controlled trial

Sara Mahmoodi, Mojtaba Yousefi, Omid Sadeghi, Ali Mahmoodabadi, Mohammadreza Sadriirani, Zahra Hosseinzade, Abdolhossein Jahanbakhsh, Seyed Bahman Panahande, Zaker Saeedinejad, Jan Mohamad Malekzadeh, Mohsen Naghmachi, Azizollah Pourmahmoudi

A systematic review of endpoint definitions in late phase pulmonary tuberculosis therapeutic trials

N. K. Hills, J. Lyimo, P. Nahid, R. M. Savic, C. Lienhardt, P. P. J. Phillips

Supported online self-management versus care as usual for symptoms of fatigue, pain and urgency/incontinence in adults with inflammatory bowel disease (IBD-BOOST): study protocol for a randomised controlled trial

Christine Norton, Jonathan Syred, Sally Kerry, Micol Artom, Louise Sweeney, Ailsa Hart, Wladyslawa Czuber-Dochan, Stephanie J. C. Taylor, Borislava Mihaylova, Chris Roukas, Qasim Aziz, Laura Miller, Richard Pollok, Sonia Saxena, Imogen Stagg, Helen Terry, Zohra Zenasni, Lesley Dibley, Rona Moss-Morris

Using a BonE BiOPsy (BeBoP) to determine the causative agent in persons with diabetes and foot osteomyelitis: study protocol for a multicentre, randomised controlled trial

Meryl Cinzía Tila Tamara Gramberg, Rimke Sabine Lagrand, Louise Willy Elizabeth Sabelis, Martin den Heijer, Vincent de Groot, Max Nieuwdorp, Willemijn Kortmann, Elske Sieswerda, Edgar Josephus Gerardus Peters

Efficacy of low-load resistance training combined with blood flow restriction vs. high-load resistance training on sarcopenia among community-dwelling older Chinese people: study protocol for a 3-arm randomized controlled trial

Nan Chen, Xiangfeng He, Guoyun Zhao, Linqian Lu, Barbara E. Ainsworth, Yu Liu, Xie Wu

Comparing two fluoride therapies for caries management in young children: study protocol for a randomised clinical trial

Sherry Shiqian Gao, Faith Miaomiao Zheng, Kitty Jieyi Chen, Duangporn Duangthip, Edward Chin Man Lo, Chun Hung Chu

The implications of outcome truncation in reproductive medicine RCTs: a simulation platform for trialists and simulation study

Jack Wilkinson, Jonathan Y. Huang, Antonia Marsden, Michael O. Harhay, Andy Vail, Stephen A. Roberts

Impact of a medico-pharmaceutical follow-up and an optimized communication between hospital and community on the readmission to the emergency department for an adverse drug event: URGEIM, study protocol for a randomized controlled trial

Cyril Breuker, Marie Faucanié, Marion Laureau, Damien Perier, Véronique Pinzani, Grégory Marin, Mustapha Sebbane, M. Villiet

The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) program: study protocol for a randomized controlled trial

Kar-Fu Yeung, Mihir Gandhi, Amanda Yun Rui Lam, Selly Julianty, Alvin Yeow Meng Chia, Gilbert Choon Seng Tan, Su-Yen Goh, Emily Tse Lin Ho, Angela Fang Yung Koh, Gavin Siew Wei Tan, Eugene Jin Wen Shum, Eric A. Finkelstein, Tazeen H. Jafar, Yee Leong Teoh, Rob M. van Dam, Clare Whitton, Julian Thumboo, Yong Mong Bee

A prospective randomised control trial comparing functional with mechanical axis alignment in total knee arthroplasty: study protocol for an investigator initiated trial

Richard Steer, Beth Tippett, R. Nazim Khan, Dermot Collopy, Gavin Clark

Caudal epidural steroid injections versus selective nerve root blocks for single-level lumbar spinal stenosis: a study protocol for a randomized controlled trial

Akram Osman, Wei Hu, Jianhua-Sun, Jing Li, Xiao Luo, Nianrong Han, Ehsan Abduhani, Zhenqiang Liu

The effect of a case-finding app on the detection rate of atrial fibrillation compared with opportunistic screening in primary care patients: protocol for a cluster randomized trial

Simon Gabriël Beerten, Tine Proesmans, Bert Vaes

Effectiveness of an interactive web-based health program for adults: a study protocol for three concurrent controlled-randomized trials (EVA-TK-Coach)

Iris Tinsel, Gloria Metzner, Christian Schlett, Matthias Sehlbrede, Martina Bischoff, Robin Anger, Judith Brame, Daniel König, Ramona Wurst, Reinhard Fuchs, Peter Lindinger, Rainer Bredenkamp, Erik Farin-Glattacker

Intervention with inulin prior to and during sanative therapy to further support periodontal health: study protocol for a randomized controlled trial

Carly A. R. Zanatta, Peter C. Fritz, Elena M. Comelli, Wendy E. Ward

The NUDGE trial pragmatic trial to enhance cardiovascular medication adherence: study protocol for a randomized controlled trial

Russell E. Glasgow, Christopher E. Knoepke, David Magid, Gary K. Grunwald, Thomas J. Glorioso, Joy Waughtal, Joel C. Marrs, Sheana Bull, P. Michael Ho

C-STICH2: emergency cervical cerclage to prevent miscarriage and preterm birth—study protocol for a randomised controlled trial

Victoria Hodgetts-Morton, Catherine A. Hewitt, Laura Jones, Lisa Leighton, Nicole Pilarski, Eleanor Molloy, Kim Hinshaw, Jane Norman, Jason Waugh, Sarah Stock, Jim Thornton, Philip Toozs-Hobson, Tracey Johnston, Arri Coomarasamy, Shakila Thangaratinam, Ben Mol, Eva Pajkrt, Neil Marlow, Tracy Roberts, Lee Middleton, Peter Brocklehurst, Katie Morris

Comparison of iguratimod and conventional cyclophosphamide with sequential azathioprine as treatment of active lupus nephritis: study protocol for a multi-center, randomized, controlled clinical trial (iGeLU study)

Qingran Yan, Fang Du, Yuening Kang, Ping Ye, Xiaodong Wang, Jianhua Xu, Jianping Tang, Niansong Wang, Gengru Jiang, Zhijun Li, Xuan Wang, Qin Xue, Xinfang Huang, Xiaoyan Zhang, Ying Zhou, Min Dai, Chunde Bao

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

Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women

Anna L. MacKinnon, Joshua W. Madsen, Ashley Dhillon, Elizabeth Keys, Gerald F. Giesbrecht, Tyler Williamson, Amy Metcalfe, Tavis Campbell, Kelly J. Mrklas, Lianne Tomfohr-Madsen

Correction to: Intradermal acupuncture for rheumatoid arthritis: study protocol for a randomised controlled trial

Huifang Luo, Jie Peng, Qing Ma, Zhihua Wei, Changsong Lin, Mingying Zhang, Peiwu Li, Yang Song, Xiangwei Yang

Effects of moderate-intensity intermittent hypoxic training on health outcomes of patients recovered from COVID-19: the AEROBICOVID study protocol for a randomized controlled trial

Átila Alexandre Trapé, Marta Camacho-Cardenosa, Alba Camacho-Cardenosa, Eugenio Merellano-Navarro, Jhennyfer Aline Lima Rodrigues, Elisangela Aparecida da Silva Lizzi, Carlos Arterio Sorgi, Marcelo Papoti, Javier Brazo-Sayavera

Comparing the effects of self-selected MUsic versus predetermined music on patient ANXiety prior to gynaecological surgery: the MUANX randomized controlled trial

D. Reynaud, N. Bouscaren, V. Lenclume, M. Boukerrou

Efficacy and central mechanism of acupuncture treatment in patients with neck pain: study protocol for a randomized controlled trial

Zhen Gao, Tao Yin, Lei Lan, Dehua Li, Ruirui Sun, Guodong Ha, Caili Jiang, Xin Shao, Zhaoxuan He, Laixi Ji, Fang Zeng

The role of machine learning in clinical research: transforming the future of evidence generation

E. Hope Weissler, Tristan Naumann, Tomas Andersson, Rajesh Ranganath, Olivier Elemento, Yuan Luo, Daniel F. Freitag, James Benoit, Michael C. Hughes, Faisal Khan, Paul Slater, Khader Shameer, Matthew Roe, Emmette Hutchison, Scott H. Kollins, Uli Broedl, Zhaoling Meng, Jennifer L. Wong, Lesley Curtis, Erich Huang, Marzyeh Ghassemi

Correction to: Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial

Ulrich Reininghaus, Annelie Klippel, Henrietta Steinhart, Thomas Vaessen, Martine van Nierop, Wolfgang Viechtbauer, Tim Batink, Zuzana Kasanova, Evelyne van Aubel, Ruud van Winkel, Machteld Marcelis, Therese van Amelsvoort, Mark van der Gaag, Lieuwe de Haan, Inez Myin-Germeys

Anonymous online cognitive behavioral therapy for sleep disorders in shift workers—a study protocol for a randomized controlled trial

Lukas Retzer, Monika Feil, Richard Reindl, Kneginja Richter, Robert Lehmann, Mark Stemmler, Elmar Graessel

Chlorhexidine–alcohol versus povidone–iodine as preoperative skin antisepsis for prevention of surgical site infection in cesarean delivery—a pilot randomized control trial

Athokpam Lenin Luwang, Pradip Kumar Saha, Minakshi Rohilla, Pooja Sikka, Lekha Saha, Vikas Gautam

Zelen design clinical trials: why, when, and how

Gregory E. Simon, Susan M. Shortreed, Lynn L. DeBar

Evaluating implementation of LEAPS, a youth-led early childhood care and education intervention in rural Pakistan: protocol for a stepped wedge cluster-randomized trial

Aisha K. Yousafzai, Christopher R. Sudfeld, Emily E. Franchett, Saima Siyal, Karima Rehmani, Shelina Bhamani, Quanyi Dai, Chin R. Reyes, Günther Fink, Liliana A. Ponguta

Efficacy and safety of secukinumab in patients with giant cell arteritis: study protocol for a randomized, parallel group, double-blind, placebo-controlled phase II trial

Nils Venhoff, Wolfgang A. Schmidt, Peter Lamprecht, Hans-Peter Tony, Christine App, Christian Sieder, Carolin Legeler, Claudia Jentzsch, Jens Thiel

An evaluation of the process of informed consent: views from research participants and staff

Lydia O’ Sullivan, Laura Feeney, Rachel K. Crowley, Prasanth Sukumar, Eilish McAuliffe, Peter Doran

Efficacy and safety of the Chinese herbal formula Hewei Jiangni recipe for NERD with cold-heat complex syndrome: study protocol for a double-blinded randomized controlled trial

Xiaosi Zhang, Yuan Cheng, Xiaohong Li, Xiang Tan, Lei Shi, Xiaojun Shi, Xiancui Zhang, Chun’e Xie, Junxiang Li

Early high-dose vitamin C in post-cardiac arrest syndrome (VITaCCA): study protocol for a randomized, double-blind, multi-center, placebo-controlled trial

Sander Rozemeijer, Harm-Jan de Grooth, Paul W. G. Elbers, Armand R. J. Girbes, Corstiaan A. den Uil, Eric A. Dubois, Evert-Jan Wils, Thijs C. D. Rettig, Arthur R. H. van Zanten, Roel Vink, Bas van den Bogaard, Rob J. Bosman, Heleen M. Oudemans-van Straaten, Angélique M. E. de Man

Feasibility of Comparative Health Research Outcome of Novel Surgery in prostate cancer (IP4-CHRONOS): statistical analysis plan for the randomised feasibility phase of the CHRONOS study

Emily Day, A. Toby Prevost, Matthew R. Sydes, Deepika Reddy, Taimur T. Shah, Mathias Winkler, Tim Dudderidge, John Staffurth, Stuart McCracken, Vincent Khoo, Puja Jadav, Natalia Klimowska-Nassar, Thiagarajah Sasikaran, Hashim U. Ahmed, Francesca Fiorentino

Effects of autonomic nervous system activation on endothelial function in response to acute exercise in hypertensive individuals: study protocol for a randomized double-blind study

Gustavo Waclawovsky, Liliana Fortini Cavalheiro Boll, Salvador Gomes Neto, Maria Claudia Costa Irigoyen, Alexandre M. Lehnen

Real-time interactive digital healthcare system for post-operative breast cancer patients: study protocol for a randomized controlled trial

Hae-Yeon Park, Kyung Eun Nam, Jae-Young Lim, Seung Mi Yeo, Jong In Lee, Ji Hye Hwang

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

The Spinal Cord Injury Program in Exercise (SCIPE) study: study protocol for a randomized controlled trial evaluating teleexercise programs for people with spinal cord injury

Hui-Ju Young, Tapan Mehta, Yumi Kim, Sangeetha Padalabalanarayanan, Chia-Ying Chiu, James H. Rimmer, Mohanraj Thirumalai

Physiological stress in safer cycling in older age (SiFAr-stress): effect of a multicomponent exercise intervention—a study protocol for a randomized controlled trial

Sabine Britting, Robert Kob, Cornel Christian Sieber, Nicolas Rohleder, Ellen Freiberger, Linda Becker

Efficacy and safety of Qi-Jing Hui-Xin Decoction in the treatment of coronary microvascular angina: study protocol for a randomized, controlled, multi-center clinical trial

Yuanlong Sun, Chengxin Huang, Li Huo, Ying Li, Jun Chen, Zixiu Zhang, Meijun Jia, Meixian Jiang, Xiaofen Ruan

Evaluation of the effectiveness of an incentive strategy on the questionnaire response rate in parents of premature babies: a randomised controlled Study Within A Trial (SWAT) nested within SIFT

Edmund Juszczak, Oliver Hewer, Christopher Partlett, Madeleine Hurd, Vasha Bari, Ursula Bowler, Louise Linsell, Jon Dorling, Vasha Bari, Janet Berrington, Ursula Bowler, Elaine Boyle, Jon Dorling, Nicholas Embleton, Oliver Hewer, Madeleine Hurd, Samantha Johnson, Edmund Juszczak, Andrew King, Alison Leaf, Louise Linsell, Kenny McCormick, William McGuire, David Murray, Christopher Partlett, Tracy Roberts, Ben Stenson

Simethicone administration improves gastric cleanness for esophagogastroduodenoscopy: a randomized clinical trial

Xiaotian Sun, Yang Xu, Xueting Zhang, Cuiyun Ma, Aitong Li, Haiyan Yu, Weihua Zhang, Hanqing Zhang, Teng Yang, Xinfang Miao, Huiming Zhang, Yan Liu, Zheng Lu

ONCOGRAM: study protocol for the evaluation of therapeutic response and survival of metastatic colorectal cancer patients treated according to the guidelines of a chemosensitivity assay, the Oncogramme®

Muriel Mathonnet, Mathieu Vanderstraete, Christophe Bounaix Morand du Puch, Stéphanie Giraud, Christophe Lautrette, Mehdi Ouaissi, Nicolas Tabchouri, Abdelkader Taïbi, Renaud Martin, Isabelle Herafa, Achille Tchalla, Niki Christou, B. Marin, S. Bouvier, S. Durand-Fontanier, A. Fabre, D. Valleix, T. Rivaille, F. Fredon, S. Derbal, P. Carrier, R. Daloko Lonfo, R. Legros, S. Lavau-Denes, V. Lebrun-Ly, F. Thuillier, P. Engel, A. Chaunavel, M. Pradel, D. Pezet, A. Dubois, C. Pétorin, O. Antomarchi, A. Aboukassem, A. Vimal-Baguet, B. Gillet, B. Mathieu, J. Joubert-Zakeyh, S. Evrard, Y. Becouarn, D. Béchade, M. Fonk, G. Desolneux, N. Dauriat, M. Agbo, M. Louty, F. Borie, S. Lyubimova, V. Phoutthasang, B. Brunaud-Gagniard, Y. Benadjaoud, N. Rolland, L. Letournoux, P. Roger, L. Chen, Z. Amadou, C. Christopoulous, G. Nakahl, Y. Souliman, M. N. Cirt, D. Ducoux, P. A. Boisseau, P. Pardies, L. Mesturoux, L. Vayre, A. Abdeh, F. Teboul, R. Landraud, M. Ouaissi, E. Salamé, N. Tabchouri, T. Lecomte, G. Proutheau, S. Guyetant, D. Tougeron, A. de Singly, A. Ferru, R. El Fadel, T. Courvoisier, A. Junca, E. Frouin, L. Rouleau, S. Rafaert, A. Rocher, J-M Regimbeau, C. Sabbagh, E. Dumange, E. Chive, D. Lignier, N. Siembida, B. Chauffert, V. Hautefeuille, D. Chatelain, E. Rivkine

Effective recruitment strategies in an exercise trial for patients with fibromyalgia

Michelle Park, Raveendhara R. Bannuru, Lori Lyn Price, William F. Harvey, Jeffrey B. Driban, Chenchen Wang

Postoperative 20% albumin vs standard care and acute kidney injury after high-risk cardiac surgery (ALBICS): study protocol for a randomised trial

Mayurathan Balachandran, Piyusha Banneheke, Adrian Pakavakis, Wisam Al-Bassam, Vineet Sarode, Michael Rowland, Yahya Shehabi

Internet-based stress recovery intervention FOREST for healthcare staff amid COVID-19 pandemic: study protocol for a randomized controlled trial

Lina Jovarauskaite, Austeja Dumarkaite, Inga Truskauskaite-Kuneviciene, Ieva Jovaisiene, Gerhard Andersson, Evaldas Kazlauskas

Targeting autonomic flexibility to enhance cognitive training outcomes in older adults with mild cognitive impairment: study protocol for a randomized controlled trial

Feng V. Lin, Kathi Heffner, Richard Gevirtz, Zhengwu Zhang, Duje Tadin, Anton Porsteinsson

Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2

Wendy Holman, Wayne Holman, Stacy McIntosh, Wendy Painter, George Painter, Jim Bush, Oren Cohen

Application of virtual reality on non-drug behavioral management of short-term dental procedure in children

Longkuan Ran, Nan Zhao, Lin Fan, Pinping Zhou, Chao Zhang, Cong Yu

Transcutaneous electrical acupoint stimulation for postoperative cognitive dysfunction in geriatric patients with gastrointestinal tumor: a randomized controlled trial

Lijuan Xi, Fang Fang, Haijuan Yuan, Daorong Wang

CRISTAL (a cluster-randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study): statistical analysis plan

Verinder Singh Sidhu, Thu-Lan Kelly, Nicole Pratt, Steven Graves, Rachelle Buchbinder, Justine Naylor, Richard de Steiger, Ilana Ackerman, Sam Adie, Michelle Lorimer, Durga Bastiras, Kara Cashman, Ian Harris

The SHINE trial (a multicentre, randomised trial of stabilisation with nasal high flow during neonatal endotracheal intubation): statistical analysis plan

Kate Hodgson, Brett Manley, Omar Kamlin, Louise Owen, Calum Roberts, Kate Francis, Peter Davis, Susan Donath

Effect of Lycium barbarum polysaccharide supplementation in non-alcoholic fatty liver disease patients: study protocol for a randomized controlled trial

Lu-Lu Gao, Yu-Xiang Li, Jia-Min Ma, Yi-Qiong Guo, Lin Li, Qing-Han Gao, Yan-Na Fan, Meng-Wei Zhang, Xiu-Juan Tao, Jian-Qiang Yu, Jian-Jun Yang

Making large-scale surgical trials possible: collaboration and the role of surgical trainees

Marcus Jepson, Michelle Lazaroo, Samir Pathak, Natalie Blencowe, Jane Collingwood, Madeleine Clout, Giles Toogood, Jane Blazeby

Randomized phase II study of gemcitabine and S-1 combination therapy versus gemcitabine and nanoparticle albumin-bound paclitaxel combination therapy as neoadjuvant chemotherapy for resectable/borderline resectable pancreatic ductal adenocarcinoma (PDAC-GS/GA-rP2, CSGO-HBP-015)

Daisaku Yamada, Shogo Kobayashi, Hidenori Takahashi, Hirofumi Akita, Terumasa Yamada, Tadafumi Asaoka, Junzo Shimizu, Yutaka Takeda, Shigekazu Yokoyama, Masanori Tsujie, Akira Tomokuni, Masahiro Tanemura, Osakuni Morimoto, Masahiro Murakami, Yongkook Kim, Shin Nakahira, Naoki Hama, Keishi Sugimoto, Kazuhiko Hashimoto, Yuichiro Doki, Hidetoshi Eguchi

Clinical and healthcare improvement through My Health Record usage and education in general practice (CHIME-GP): a study protocol for a cluster-randomised controlled trial

Andrew Bonney, Christine Metusela, Judy Mullan, Stephen Barnett, Joel Rhee, Conrad Kobel, Marijka Batterham

Efficacy of two siddha polyherbal decoctions, Nilavembu Kudineer and Kaba Sura Kudineer, along with standard allopathy treatment in the management of mild to moderate symptomatic COVID-19 patients—a double-blind, placebo-controlled, clinical trial

Anurag Srivastava, Manickavasagam Rengaraju, Saurabh Srivastava, Vimal Narayanan, Vivek Gupta, Rashmi Upadhayay, Jitender Kumar, Sathiyarajeswaran Parameswaran, KanakavalliKadarkarai, AarthiVelmurugan

The impact of physical training on length of hospital stay and physical function in patients hospitalized with community-acquired pneumonia: protocol for a randomized controlled trial

Camilla Koch Ryrsø, Daniel Faurholt-Jepsen, Christian Ritz, Bente Klarlund Pedersen, Maria Hein Hegelund, Arnold Matovu Dungu, Adin Sejdic, Birgitte Lindegaard, Rikke Krogh-Madsen

Reducing the burden of orthodontic care for children with clefts: evaluating the effectiveness of pre-alveolar bone graft orthodontics in unilateral non-syndromic cleft patients (PABO study)— A study protocol for a multicentric randomised controlled trial

Badri Thiruvenkatachari, Syed Altaf Hussain, Puneet Batra, Charanya Vijayakumar, Manoj Prathap. C

Protocol for the Controlled evaLuation of Angiotensin Receptor blockers for COVID-19 respIraTorY disease (CLARITY): a randomised controlled trial

Carinna Hockham, Sradha Kotwal, Arlen Wilcox, Abhinav Bassi, James McGree, Carol Pollock, Louise M. Burrell, Nikita Bathla, Mallikarjuna Kunigari, Vinay Rathore, Michael John, Enmoore Lin, Christine Jenkins, Angus Ritchie, Andrew McLachlan, Thomas Snelling, Mark Jones, Vivekanand Jha, Meg Jardine

Effectiveness of deep cervical fascial manipulation and yoga postures on pain, function, and oculomotor control in patients with mechanical neck pain: study protocol of a pragmatic, parallel-group, randomized, controlled trial

Prabu Raja G, Shyamasunder Bhat N, César Fernández-de-las-Peñas, Ranganath Gangavelli, Fiddy Davis, Ravi Shankar, Anupama Prabhu

“More air—better performance—faster recovery”: study protocol for randomised controlled trial of the effect of post-stroke inspiratory muscle training for adults

Susanne Lillelund Sørensen, Simon Svanborg Kjeldsen, Sine Secher Mortensen, Ulla Torp Hansen, Dorthe Hansen, Asger Roger Pedersen, Hanne Pallesen

2-Hydroxybenzylamine (2-HOBA) to prevent early recurrence of atrial fibrillation after catheter ablation: protocol for a randomized controlled trial including detection of AF using a wearable device

Matthew J. O’Neill, Zachary T. Yoneda, Diane M. Crawford, Fei Ye, Mingfang Ao, Lisa M. Pitchford, John A. Rathmacher, Katherine T. Murray, Wendell S. Akers, Dan M. Roden, Gregory F. Michaud, M. Benjamin Shoemaker

Randomized controlled trial of neurologic music therapy in Parkinson’s disease: research rehabilitation protocols for mechanistic and clinical investigations

Isabelle Buard, Lucas Lattanzio, Rebekah Stewart, Sarah Thompson, Kristin Sjoberg, Karen Hookstadt, Meghan Morrow, Samantha K. Holden, Stefan Sillau, Michael Thaut, Benzi Kluger

Protecting clinical trials in cystic fibrosis during the SARS-CoV-2 pandemic: risks and mitigation measures

Silke van Koningsbruggen-Rietschel, Fiona Dunlevy, Veerle Bulteel, Kate Hayes, Anne Verbrugge, Hettie M. Janssens, Nadine Dufeu, Nicholas J. Simmonds, Lieven J. Dupont, Damian G. Downey

Study protocol for the Exercising Together© trial: a randomized, controlled trial of partnered exercise for couples coping with cancer

Kerri M. Winters-Stone, Karen S. Lyons, Nathan F. Dieckmann, Christopher S. Lee, Zahi Mitri, Tomasz M. Beer

Teriparatide and stress fracture healing in young adults (RETURN – Research on Efficacy of Teriparatide Use in the Return of recruits to Normal duty): study protocol for a randomised controlled trial

Alexander T. Carswell, Katharine G. Eastman, Anna Casey, Matthew Hammond, Lee Shepstone, Estelle Payerne, Andoni P. Toms, James W. MacKay, Ann Marie Swart, Julie P. Greeves, William D. Fraser

The impact of frailty Screening of Older adults with muLtidisciplinary assessment of those At Risk during emergency hospital attendance on the quality, safety and cost-effectiveness of care (SOLAR): a randomised controlled trial.

Aoife Leahy, Rachel McNamara, Catriona Reddin, Gillian Corey, Ida Carroll, Aoife O’Neill, Darragh Flannery, Collette Devlin, Louise Barry, Brian MacCarthy, Niamh Cummins, Elaine Shanahan, Denys Shchetkovsky, Damien Ryan, Margaret O’Connor, Rose Galvin

Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial

Aline Marcadenti, Bernardete Weber, Angela Cristine Bersch-Ferreira, Rachel Helena Vieira Machado, Camila Ragne Torreglosa, Enilda Maria de Sousa Lara, Lucas Ribeiro da Silva, Renato Hideo Nakagawa Santos, Debora Harumi Kodama Miyada, Erica Regina Ribeiro Sady, Rosana Perim Costa, Leopoldo Piegas, Erlon Oliveira de Abreu-Silva, Alexandre Schaan de Quadros, Camila Weschenfelder, Júlia Lorenzon dos Santos, Gabriela Corrêa Souza, Suena Medeiros Parahiba, Ana Paula Trussardi Fayh, Danielle Soares Bezerra, Ana Paula Perillo Ferreira Carvalho, Malaine Morais Alves Machado, Sandra Mary Lima Vasconcelos, Jéssika Araújo, José Albuquerque de Figueiredo Neto, Luciana Pereira Pinto Dias, Francisca Eugenia Zaina Nagano, Cássia Cristina Paes de Almeida, Annie Seixas Bello Moreira, Débora Pinto Gapanowicz, Eduardo Purgatto, Marcelo Macedo Rogero, Geni Rodrigues Sampaio, Elizabeth Aparecida Ferraz da Silva Torres, Graziela Biude Silva Duarte, Alexandre Biasi Cavalcanti

Correction to: Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries

Moses Badio, Edouard Lhomme, Mark Kieh, Abdoul Habib Beavogui, Stephen B. Kennedy, Seydou Doumbia, Bailah Leigh, Samba O. Sow, Alpha Diallo, Daniela Fusco, Matthew Kirchoff, Monique Termote, Renaud Vatrinet, Deborah Wentworth, Helène Esperou, H. Clifford Lane, Jerome Pierson, Deborah Watson-Jones, Céline Roy, Eric D’Ortenzio, Brian Greenwood, Genevieve Chêne, Laura Richer, James D. Neaton, Yazdan Yazdanpanah

Antiviral and immunomodulatory interferon-beta in high-risk COVID-19 patients: a structured summary of a study protocol for a randomised controlled trial

Eleonora Aricò, Luciano Castiello, Laura Bracci, Francesca Urbani, Flavia Lombardo, Ilaria Bacigalupo, Antonio Ancidoni, Nicola Vanacore, Alessandro Falcione, Chiara Reggiani, Giovanni Marco Dutti, Maria Grazia Maglie, Ombretta Papa, Pier Luigi Bartoletti, Giuseppina Ozzella, Nazario Bevilacqua, Emanuele Nicastri, Filippo Belardelli, Giuseppe Sconocchia

The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

Jingjing Huang, Yimin Yu, Yi Jiang, Wu Chen, Yan Li, Yifeng Shen, Qingshan Zheng, Huafang Li

Efficacy of Yijinjing combined with Tuina for patients with non-specific chronic neck pain: study protocol for a randomized controlled trial

Ziji Cheng, Ziying Chen, Fangfang Xie, Chong Guan, Yuanjia Gu, Ruiping Wang, Yanli You, Fei Yao

Effects of intrinsic-foot-muscle exercise combined with the lower extremity resistance training on postural stability in older adults with fall risk: study protocol for a randomised controlled trial

Zhangqi Lai, Hongbo Pang, Xiaoyue Hu, Kun Dong, Lin Wang

The effect of in-person and virtual prenatal care education of the spouses of primiparous women on the father and mother’s attachment to infant: a quasi-experimental and controlled study

Zari Doaltabadi, Leila Amiri-Farahani

Exploring the inclusion of under-served groups in trials methodology research: an example from ethnic minority populations’ views on deferred consent

Timia Raven-Gregg, Victoria Shepherd

The effectiveness of early colchicine administration in patients over 60 years old with high risk of developing severe pulmonary complications associated with coronavirus pneumonia SARS-CoV-2 (COVID-19): study protocol for an investigator-driven randomized controlled clinical trial in primary health care—COLCHICOVID study

Elena Bustamante Estebanez, Lucía Lavín Alconero, Beatriz Josa Fernández, Monica Gozalo Marguello, Juan Carlos López Caro, Jonathan Diez Vallejo, Marta Fernandez Sampedro, Pedro Muñoz Cacho, Carlos Richard Espiga, María Mar García Saiz

Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial

Shoaib Ashraf, Sohaib Ashraf, Iqra Farooq, Sidra Ashraf, Moneeb Ashraf, Muhammad Ahmad Imran, Larab Kalsoom, Rutaba Akmal, Muhammad Ghufran, Sundas Rafique, Muhammad Kiwan Akram, Zaigham Habib, Uzma Nasim Siddiqui, Ammara Ahmad, Shahroze Arshad, Muhammad Abdul Rehman Virk, Mehak Gul, Abeer bin Awais, Muhammad Hassan, Syed Sami Hussain Sherazi, Zartasha Safdar, Isra Munir, Hamna Khalid, Khalid Munir, Nighat Majeed, Yaser Masuod Alahmadi, Ayesha Humayun, Qazi Abdul Saboor, Ali Ahmad, Muhammad Ashraf, Mateen Izhar, Abubakr Hilal, Arz Muhammad, Zeeshan Shaukat, Sohail Ahmad, Kanwal Hayat, Ghazala Amjad, Misbah Kousar, Hadiqa Tul Hafsa, Zawar Ahmad Choudhary, Umair Hafeez, Tayyab Mughal, Noman Khalid, Qurat-ul-Ain Iqbal, Roa Umer, Tayyaba Muzafar, Sibgha Zulfiqar, Saadia Shahzad Alam, Saulat Sarfraz, Muhammad Imran Anwar, Amber Malik, Talha Mahmud, Adeen Akmal, Muhammad Faisal Nadeem, Nazish Matti, Muhammad Azam, Nighat Majeed, Ali Arshad, Khawar Nawaz, Muhammad Ismail Khalid Yousaf, Aadil Maqsood Atif Amin Baig, Muhammad Bilal, Muhammad Nauman Zahid

The effect of framing and communicating COVID-19 vaccine side-effect risks on vaccine intentions for adults in the UK and the USA: A structured summary of a study protocol for a randomized controlled trial

Nikkil Sudharsanan, Caterina Favaretti, Violetta Hachaturyan, Till Bärnighausen, Alain Vandormael

Correction to: The role of machine learning in clinical research: transforming the future of evidence generation

E. Hope Weissler, Tristan Naumann, Tomas Andersson, Rajesh Ranganath, Olivier Elemento, Yuan Luo, Daniel F. Freitag, James Benoit, Michael C. Hughes, Faisal Khan, Paul Slater, Khader Shameer, Matthew Roe, Emmette Hutchison, Scott H. Kollins, Uli Broedl, Zhaoling Meng, Jennifer L. Wong, Lesley Curtis, Erich Huang, Marzyeh Ghassemi

Acupuncture for combat post-traumatic stress disorder: trial development and methodological approach for a randomized controlled clinical trial

Michael Hollifield, An-Fu Hsiao, Kala Carrick, Andrea Gory Munoz, Teresa Calloway, Karen Cocozza, Besa Smith, Tyler Smith, Tanja Jovanovic, Seth Norrholm, Estate Sokhadze, Christopher Reist

Efficacy and safety of intramuscular administration of allogeneic adipose tissue derived and expanded mesenchymal stromal cells in diabetic patients with critical limb ischemia with no possibility of revascularization: study protocol for a randomized controlled double-blind phase II clinical trial (The NOMA Trial)

Barbara Soria-Juan, Mariano Garcia-Arranz, Lucía Llanos Jiménez, César Aparicio, Alejandro Gonzalez, Ignacio Mahillo Fernandez, Luis Riera del Moral, Lukasz Grochowicz, Enrique J. Andreu, Pedro Marin, Gregorio Castellanos, Jose Maria Moraleda, Ana Maria García-Hernández, Francisco S. Lozano, Fermin Sanchez-Guijo, Eva María Villarón, Miriam Lopez Parra, Rosa María Yañez, Antonio de la Cuesta Diaz, Juan Rigoberto Tejedo, Francisco J. Bedoya, Franz Martin, Manuel Miralles, Lourdes del Rio Sola, María Eugenia Fernández-Santos, José Manuel Ligero, Francisco Morant, Luis Hernández-Blasco, Etelvina Andreu, Abdelkrim Hmadcha, Damian Garcia-Olmo, Bernat Soria

Additional effect of pain neuroscience education to craniocervical manual therapy and exercises for pain intensity and disability in temporomandibular disorders: a study protocol for a randomized controlled trial

Aroldo dos Santos Aguiar, Cesar Bataglion, Lilian Ramiro Felício, Beatriz Azevedo, Thaís Cristina Chaves

Patient perceptions of the challenges of recruitment to a renal randomised trial registry: a pilot questionnaire-based study

Ellen Murphy, Aoife O’Keeffe, Niamh O Shea, Eva Long, Joseph A. Eustace, Frances Shiely

Power and sample size calculation for stepped-wedge designs with discrete outcomes

Fan Xia, James P. Hughes, Emily C. Voldal, Patrick J. Heagerty

Postpartum Early EMDR therapy Intervention (PERCEIVE) study for women after a traumatic birth experience: study protocol for a randomized controlled trial

Y. M. G. A. Hendrix, K. S. M. van Dongen, A. de Jongh, M. G. van Pampus

Protocol for a multi-phase, mixed methods study to develop and evaluate culturally adapted CBT to improve community mental health services for Canadians of south Asian origin

Farooq Naeem, Andrew Tuck, Baldev Mutta, Puneet Dhillon, Gary Thandi, Azaad Kassam, Nimo Farah, Aamna Ashraf, M. Ishrat Husain, M. Omair Husain, Helen-Maria Vasiliadis, Marcos Sanches, Tariq Munshi, Maureen Abbott, Nicholas Watters, Sean A. Kidd, Muhammad Ayub, Kwame McKenzie

The praziquantel in preschoolers (PIP) trial: study protocol for a phase II PK/PD-driven randomised controlled trial of praziquantel in children under 4 years of age

Emily L. Webb, Andrew Edielu, Hannah W. Wu, Narcis B. Kabatereine, Edridah M. Tukahebwa, Alfred Mubangizi, Moses Adriko, Alison M. Elliott, William W. Hope, Patrice A. Mawa, Jennifer F. Friedman, Amaya L. Bustinduy

Correction to: The Treatment In Morning versus Evening (TIME) study: analysis of recruitment, follow-up and retention rates post-recruitment

David A. Rorie, Robert W. V. Flynn, Isla S. Mackenzie, Thomas M. MacDonald, Amy Rogers

The future is now: our experience starting a remote clinical trial during the beginning of the COVID-19 pandemic

Hans H. Liu, Michael D. Ezekowitz, Michele Columbo, Oneib Khan, Jack Martin, Judith Spahr, David Yaron, Lisa Cushinotto, Luciano Kapelusznik

Effects of proximal priority and distal priority robotic priming techniques with impairment-oriented training of upper limb functions in patients with chronic stroke: study protocol for a single-blind, randomized controlled trial

Yi-chen Lee, Yi-chun Li, Keh-chung Lin, Chia-ling Chen, Yi-hsuan Wu, Chihchieh Kuo, Yi-ping Yeh, Ting-xuan Liu

Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19

Shakira Milton, Jennifer McIntosh, Lucy Boyd, Napin Karnchanachari, Finlay Macrae, Jon David Emery

Endoscopic sinus surgery (ESS) to change quality of life for adults with recurrent rhinosinusitis: study protocol for a randomized controlled trial

Heidi M. Kaski, Antti Alakärppä, Ulla Lantto, Aleksi Laajala, Paulus Tokola, Tomi Penna, Pasi Ohtonen, Olli-Pekka Alho

Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial

Marek Holy, Anna MacDowall, Freyr Gauti Sigmundsson, Claes Olerud

Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial

Jony van Hilst, Maarten Korrel, Sanne Lof, Thijs de Rooij, Frederique Vissers, Bilal Al-Sarireh, Adnan Alseidi, Adrian C. Bateman, Bergthor Björnsson, Ugo Boggi, Svein Olav Bratlie, Olivier Busch, Giovanni Butturini, Riccardo Casadei, Frederike Dijk, Safi Dokmak, Bjorn Edwin, Casper van Eijck, Alessandro Esposito, Jean-Michel Fabre, Massimo Falconi, Giovanni Ferrari, David Fuks, Bas Groot Koerkamp, Thilo Hackert, Tobias Keck, Igor Khatkov, Ruben de Kleine, Arto Kokkola, David A. Kooby, Daan Lips, Misha Luyer, Ravi Marudanayagam, Krishna Menon, Quintus Molenaar, Matteo de Pastena, Andrea Pietrabissa, Rushda Rajak, Edoardo Rosso, Patricia Sanchez Velazquez, Olivier Saint Marc, Mihir Shah, Zahir Soonawalla, Ales Tomazic, Caroline Verbeke, Joanne Verheij, Steven White, Hanneke W. Wilmink, Alessandro Zerbi, Marcel G. Dijkgraaf, Marc G. Besselink, Mohammad Abu Hilal

Correction to: Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies—a statistical analysis plan for short-term outcomes

Jennifer L. Bell, Samir Gupta, Edmund Juszczak, Pollyanna Hardy, Louise Linsell

Electroacupuncture for postoperative ileus after laparoscopic surgery on colorectal cancer: study protocol for a randomized controlled trial

Jia-Kai Shao, Qian Liu, Wei Pei, Yu Wang, Na-Na Yang, Ling-Yu Qi, Jin Huang, Jing-Wen Yang, Cun-zhi Liu

Co-production of randomized clinical trials with patients: a case study in autologous hematopoietic stem cell transplant for patients with scleroderma

Magda Aguiar, Tracey-Lea Laba, Sarah Munro, Tiasha Burch, Jennifer Beckett, K. Julia Kaal, Nick Bansback, Marie Hudson, Mark Harrison

Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD): a protocol for establishing a core outcome set for adults with chronic kidney disease who do not require kidney replacement therapy

Nicole Evangelidis, Benedicte Sautenet, Magdalena Madero, Allison Tong, Gloria Ashuntantang, Laura Cortes Sanabria, Ian H. de Boer, Samuel Fung, Daniel Gallego, Andrew S. Levey, Adeera Levin, Eduardo Lorca, Ikechi G. Okpechi, Patrick Rossignol, Laura Sola, Tim Usherwood, David C. Wheeler, Yeoungjee Cho, Martin Howell, Chandana Guha, Nicole Scholes-Robertson, Katherine Widders, Andrea Matus Gonzalez, Armando Teixeira-Pinto, Andrea K. Viecelli, Amelie Bernier-Jean, Samaya Anumudu, Louese Dunn, Martin Wilkie, Jonathan C. Craig

Analysis of contamination in cluster randomized trials of malaria interventions

Lea Multerer, Tracy R. Glass, Fiona Vanobberghen, Thomas Smith

The novel effectiveness of Tai Chi on cardiopulmonary fitness among stroke patients in the recovery phase: a study protocol for a randomized controlled trial

Tianyang Tan, Yanyan Meng, Xinyu Li, Ruina Bai, Chengchao Wang, Jiaxuan Lyu, Kang Yan, Meng Liu, Chaoyang Zhang, Yulong Wei

Correction to: Making large-scale surgical trials possible: collaboration and the role of surgical trainees

Marcus Jepson, Michelle Lazaroo, Samir Pathak, Natalie Blencowe, Jane Collingwood, Madeleine Clout, Giles Toogood, Jane Blazeby

Optimization of Nutrition And Medication (OptiNAM) for acutely admitted older patients: protocol for a randomized single-blinded controlled trial

Aino L. Andersen, Morten B. Houlind, Rikke L. Nielsen, Lillian M. Jørgensen, Charlotte Treldal, Morten Damgaard, Anne Kathrine Bengaard, Helle Gybel Juul-Larsen, Louise Bolvig Laursen, Esben Iversen, Marie Kruse, Anne M. L. Pedersen, Mads Hornum, Anne M. Beck, Mette M. Pedersen, Mikkel Z. Ankarfeldt, Janne Petersen, Ove Andersen

Total or partial tonsillar resection (tonsillectomy or tonsillotomy) to change the quality of life for adults with recurrent or chronic tonsillitis: study protocol for a randomised controlled trial

Aleksi Laajala, Paulus Tokola, Timo J. Autio, Timo Koskenkorva, Mikko Tastula, Pasi Ohtonen, Esa Läärä, Olli-Pekka Alho

Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial

Sohaib Ashraf, Shoaib Ashraf, Rutaba Akmal, Moneeb Ashraf, Larab Kalsoom, Aadil Maqsood, Muhammad Ahmad Imran, Iqra Farooq, Sidra Ashraf, Uzma Nasim Siddiqui, Muhammad Ghufran, Muhammad Kiwan Akram, Nighat Majeed, Sundas Rafique, Zaigham Habib, Muhammad Sarmad Shahab, Adeen Akmal, Zeeshan Shaukat, Zain ul Abdin, Ayesha Khaqan, Shahroze Arshad, Muhammad Abdul Rehman Virk, Mehak Gul, Abeer bin Awais, Muhammad Hassan, Noman Khalid, Qurrat Ul Ain Iqbal, Tausif Ahmad, Muaaz Akram, Ameer Muhammad, Musa Khalil, Aneeq Aslam, Muhammad Umer, Syed Sami Hussain Sherazi, Zartasha Safdar, Sohail Ahmad, Muhammad Bilal, Muhammad Nauman Zahid, Abdulrahman E. Koshak, Abubakar Hilal, Ahmad Azam Malik, Usman Iqbal, Atif Amin Baig, Yaser Masuod Alahmadi, Ayesha Humayun, Amber Malik, Ali Ahmad, Muhammad Ashraf, Qazi Abdul Saboor, Mateen Izhar, Arz Muhammad, Kanwal Hayat, Ghazala Amjad, Misbah Kousar, Umair Hafeez, Tayyab Mughal, Tayyaba Muzafar, Sibgha Zulfiqar, Saadia Shahzad Alam, Muhammad Imran Anwar, Amber Malik, Talha Mahmud, Ali Arshad, Khawar Nawaz, Muhammad Ismail Khalid Yousaf

Electro-acupuncture for irritable bowel syndrome patients: study protocol for a single-blinded randomized sham-controlled clinical trial

Linda L. D. Zhong, Tsz Fung Lam, Wei Yang, Ya Zheng, Zipan Lyu, Zhaoxiang Bian

Normalising comparative effectiveness trials as clinical practice

Tom Briffa, Tanya Symons, Nikolajs Zeps, Nicola Straiton, William Odita Tarnow-Mordi, John Simes, Ian A. Harris, Melinda Cruz, Steven A. Webb, Edward Litton, Alistair Nichol, Christopher M. Williams

BiCyCLE NMES—neuromuscular electrical stimulation in the perioperative treatment of sarcopenia and myosteatosis in advanced rectal cancer patients: design and methodology of a phase II randomised controlled trial

Edward T. Pring, Laura E. Gould, George Malietzis, Philip Lung, Mina Bharal, Tutu Fadodun, Paul Bassett, Mani Naghibi, Claire Taylor, Ioanna Drami, Deeptika Chauhan, Tamsyn Street, Nader K. Francis, Thanos Athanasiou, John M. Saxton, John T. Jenkins

Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial

Marc Dohmen, Andrea Petermann-Meyer, Daniel Blei, Rebecca Bremen, Evamarie Brock-Midding, Manuela Brüne, Franziska Geiser, Burkhard Haastert, Sarah Maria Halbach, Christian Heuser, Steffen Holsteg, Lina Heier, Andrea Icks, Andre Karger, Joseph Montalbo, Hannah Nakata, Jens Panse, Till-Philip Rottmann, Kristina Sättler, Anja Viehmann, Markus Vomhof, Nicole Ernstmann, Tim H. Brümmendorf

Kabasura Kudineer (KSK), a poly-herbal Siddha medicine, reduced SARS-CoV-2 viral load in asymptomatic COVID-19 individuals as compared to vitamin C and zinc supplementation: findings from a prospective, exploratory, open-labeled, comparative, randomized controlled trial, Tamil Nadu, India

S. Natarajan, C. Anbarasi, P. Sathiyarajeswaran, P. Manickam, S. Geetha, R. Kathiravan, P. Prathiba, M. Pitchiahkumar, P. Parthiban, K. Kanakavalli, P. Balaji

Improving the continuity and coordination of ambulatory care through feedback and facilitated dialogue—a study protocol for a cluster-randomised trial to evaluate the ACD study (Accountable Care in Germany)

Leonie Sundmacher, Ronja Flemming, Verena Leve, Isabel Geiger, Sebastian Franke, Thomas Czihal, Clemens Krause, Birgitt Wiese, Frank Meyer, Matthias Brittner, Johannes Pollmanns, Johannes Martin, Paul Brandenburg, Annemarie Schultz, Emmanuelle Brua, Udo Schneider, Olga Dortmann, Christoph Rupprecht, Stefan Wilm, Wiebke Schüttig

Optimizing nutrition and oral health for caregivers—intervention protocol

Irma Nykänen, Tarja Välimäki, Liisa Suominen, Ursula Schwab

Simple compared to covariate-constrained randomization methods in balancing baseline characteristics: a case study of randomly allocating 72 hemodialysis centers in a cluster trial

Ahmed A. Al-Jaishi, Stephanie N. Dixon, Eric McArthur, P. J. Devereaux, Lehana Thabane, Amit X. Garg

Multi-centre, randomised non-inferiority trial of early treatment versus expectant management of patent ductus arteriosus in preterm infants (the BeNeDuctus trial): statistical analysis plan

Tim Hundscheid, Rogier Donders, Wes Onland, Elisabeth M. W. Kooi, Daniel C. Vijlbrief, Willem B. de Vries, Debbie H. G. M. Nuytemans, Bart van Overmeire, Antonius L. Mulder, Willem P. de Boode, Peter H. Dijk, Anton H. L. C. van Kaam, Tessa de Baat, Koen P. Dijkman, Eduardo Villamor, André A. Kroon, Remco Visser, Susanne M. de Tollenaer, Filip Cools, Marisse Meeus, Anne-Britt Johansson, Frank Derriks, Catheline Hocq, Alexandra Zecic, Tine Brink Henriksen, Kasper Jacobsen Kyng

Vaccine trials during a pandemic: potential approaches to ethical dilemmas

Manaf Alqahtani, Saad I. Mallah, Nigel Stevenson, Sally Doherty

The impact of i-PUSH on maternal and child health care utilization, health outcomes, and financial protection: study protocol for a cluster randomized controlled trial based on financial and health diaries data

Amanuel Abajobir, Richard de Groot, Caroline Wainaina, Anne Njeri, Daniel Maina, Silvia Njoki, Nelson Mbaya, Hermann Pythagore Pierre Donfouet, Menno Pradhan, Wendy Janssens, Estelle M. Sidze

Stepped care for depression at integrated chronic care centers (IC3) in Malawi: study protocol for a stepped-wedge cluster randomized controlled trial

Ryan K. McBain, Owen Mwale, Todd Ruderman, Waste Kayira, Emilia Connolly, Mark Chalamanda, Chiyembekezo Kachimanga, Brown David Khongo, Jesse Wilson, Emily Wroe, Giuseppe Raviola, Stephanie Smith, Sarah Coleman, Ksakrad Kelly, Amruta Houde, Mahlet G. Tebeka, Samuel Watson, Kazione Kulisewa, Michael Udedi, Glenn Wagner

Employing a mobile health decision aid to improve decision-making for patients with advanced prostate cancer and their decision partners/proxies: the CHAMPION randomized controlled trial study design

Lourdes R. Carhuapoma, Winter M. Thayer, Catherine E. Elmore, Jane Gildersleeve, Tanmay Singh, Farah Shaukat, Melissa K. Uveges, Tamryn Gray, Crystal Chu, Daniel Song, Patricia J. Hollen, Jennifer Wenzel, Randy A. Jones

Epidural morphine in COVID ARDS patients with high respiratory drive: a structured summary of a study protocol for a randomised controlled trial

Swagata Tripathy, P. Bhaskar Rao

ISOlation Procedure vs. conventional procedure during Distal Pancreatectomy (ISOP-DP trial): study protocol for a randomized controlled trial

Ken-ichi Okada, Manabu Kawai, Seiko Hirono, Masayuki Sho, Masaji Tani, Ippei Matsumoto, Suguru Yamada, Ryosuke Amano, Hirochika Toyama, Yo-ichi Yamashita, Takeshi Gocho, Kazuto Shibuya, Minako Nagai, Hiromitsu Maehira, Keiko Kamei, Go Ohira, Yoshihiro Shirai, Hideki Takami, Nana Kimura, Takumi Fukumoto, Hideo Baba, Yasuhiro Kodera, Akimasa Nakao, Toshio Shimokawa, Masahiro Katsuda, Hiroki Yamaue

Four-factor prothrombin complex concentrate to reduce allogenic blood product transfusion in patients with major trauma, the PROCOAG trial: study protocol for a randomized multicenter double-blind superiority study

Pierre Bouzat, Jean-Luc Bosson, Jean-Stéphane David, Bruno Riou, Jacques Duranteau, Jean-François Payen, Albrice Levrat, Paër-Selim Abback, Jacques Duranteau, Bruno Riou, Delphine Garrigue, Guillaume Marcotte, Jean-Stéphane David, Jonathan Charbit, Karim Asehnoune, Marc Leone, Julien Pottecher, Pierre Bouzat

Improving time to palliative care review with predictive modeling in an inpatient adult population: study protocol for a stepped-wedge, pragmatic randomized controlled trial

Patrick M. Wilson, Lindsey M. Philpot, Priya Ramar, Curtis B. Storlie, Jacob Strand, Alisha A. Morgan, Shusaku W. Asai, Jon O. Ebbert, Vitaly D. Herasevich, Jalal Soleimani, Brian W. Pickering

DISCO App: study protocol for a randomized controlled trial to test the effectiveness of a patient intervention to reduce the financial burden of cancer in a diverse patient population

Lauren M. Hamel, David W. Dougherty, Seongho Kim, Elisabeth I. Heath, Lorna Mabunda, Eyouab Tadesse, RaeAnn Hill, Susan Eggly

Early skin contact combined with mother’s breastfeeding to shorten the process of premature infants ≤ 30 weeks of gestation to achieve full oral feeding: the study protocol of a randomized controlled trial

Liling Li, Li Wang, Conway Niu, Chan Liu, Tianchan Lv, Futing Ji, Ling Yu, Weili Yan, Ya Lan Dou, Yin Wang, Yun Cao, Guoying Huang, Xiaojing Hu

Effects of Hydroxychloroquine on endOthelial function in eLDerly with sleep apnea (HOLD): study protocol for a randomized clinical trial

Leticia Maria Tedesco Silva, Antonio Cortes, Beatriz Rossi, Liliana Boll, Gustavo Waclawovsky, Bruna Eibel, Sandro Cadaval Gonçalves, Maria Claudia Irigoyen, Denis Martinez

ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair

Arno M. Wiersema, Liliane C. Roosendaal, Mark J. W. Koelemaij, Jan G. P. Tijssen, Susan van Dieren, Jan D. Blankensteijn, E. Sebastian Debus, Saskia Middeldorp, Jan M. M. Heyligers, Ymke S. Fokma, Michel M. P. J. Reijnen, Vincent Jongkind

Evaluation of the “Let’s Get Organized” group intervention to improve time management: protocol for a multi-centre randomised controlled trial

Marie Holmefur, Afsaneh Roshanay, Suzanne White, Gunnel Janeslätt, Elin Vimefall, Kajsa Lidström-Holmqvist

Efficacy of a transdiagnostic ecological momentary intervention for improving self-esteem (SELFIE) in youth exposed to childhood adversity: study protocol for a multi-center randomized controlled trial

Maud Daemen, Mary Rose Postma, Ramon Lindauer, Iris Hoes-van der Meulen, Dorien Nieman, Philippe Delespaul, Josefien Johanna Froukje Breedvelt, Mark van der Gaag, Wolfgang Viechtbauer, Koen Schruers, David van den Berg, Claudi Bockting, Therese van Amelsvoort, Ulrich Reininghaus

Aspirin as secondary prevention in colorectal cancer liver metastasis (ASAC trial): study protocol for a multicentre randomized placebo-controlled trial

Sheraz Yaqub, Bjørn Atle Bjørnbeth, Jon-Helge Angelsen, Claus Wilki Fristrup, Jon Erik Grønbech, Oskar Hemmingsson, Bengt Isaksson, Ingebjørg Soterud Juel, Peter Nørgaard Larsen, Gert Lindell, Frank Viborg Mortensen, Kim Erlend Mortensen, Magnus Rizell, Per Sandström, Oddvar Mathias Sandvik, Ernesto Sparrelid, Helena Taflin, Kjetil Taskén, Kristoffer W. Brudvik, Åsmund A. Fretland, Arild Horn, Dyre Kleive, Knut J. Labori, Kristoffer Lassen, Bård I. Røsok, Jon A. Søreide, Tore Tholfsen, Olaug Villanger, Anne Waage

Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability edema in patients with moderate-to-severe ARDS—a randomized, placebo-controlled, double-blind trial

Benedikt Schmid, Markus Kredel, Roman Ullrich, Katharina Krenn, Rudolf Lucas, Klaus Markstaller, Bernhard Fischer, Peter Kranke, Patrick Meybohm, Bernhard Zwißler, Sandra Frank

Assessing the fidelity of a peer-led chronic pain management program (PAP)

Mimi M. Y. Tse, Shuk Kwan Tang, Shamay Ng, Yajie Li, Daphne Sze Ki Cheung, Rick Yiu Cho Kwan

Altering Dynamics of Autonomic Processing Therapy (ADAPT) trial: a novel, targeted treatment for reducing anxiety in joint hypermobility

Geoff Davies, Jenny L. L. Csecs, Heather Ball, Jess Dare, Stephen Bremner, Robin Hosking, Hugo D. Critchley, Nick Grey, Jessica A. Eccles

Correction to: A digital health peri-operative cognitive-behavioral intervention to prevent transition from acute to chronic postsurgical pain in adolescents undergoing spinal fusion (SurgeryPalTM): study protocol for a multisite randomized controlled trial

Jennifer A. Rabbitts, Chuan Zhou, Rocio de la Vega, Homer Aalfs, Caitlin B. Murray, Tonya M. Palermo

Transcranial direct current stimulation (tDCS) in addition to walking training on walking, mobility, and reduction of falls in Parkinson’s disease: study protocol for a randomized clinical trial

Lucas Rodrigues Nascimento, Ester Miyuki Nakamura-Palacios, Augusto Boening, Bárbara Naeme Lima Cordeiro, Daniel Lyrio Cabral, Alessandra Swarowsky, Guilherme Peixoto Tinoco Arêas, Wellingson Silva Paiva, Fernando Zanela da Silva Arêas

Effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial

Emma Robson, Steven J. Kamper, Alix Hall, Hopin Lee, Simon Davidson, Priscilla Viana da Silva, Connor Gleadhill, Christopher M. Williams, Damien Smith, Bruce Donald, Catherine Groves, Martin O’Neill, Emma-Leigh Simpson, Kate Reid, Tahila Reynolds, Rebecca Muddle, Lauren Devine, Rebecca Hodder, Amanda Williams, John Wiggers, Karen Gillham, Chris Barnett, Robin Haskins, Andrew Searles, Rod Ling, Erin Nolan, Christopher Oldmeadow

RAPIDIRON: Reducing Anaemia in Pregnancy in India—a 3-arm, randomized-controlled trial comparing the effectiveness of oral iron with single-dose intravenous iron in the treatment of iron deficiency anaemia in pregnant women and reducing low birth weight deliveries

Richard J. Derman, Shivaprasad S. Goudar, Simal Thind, Sudhir Bhandari, Zubair Aghai, Michael Auerbach, Rupsa Boelig, Umesh S. Charantimath, Rosemary Frasso, M. S. Ganachari, Kusum Lata Gaur, Michael K. Georgieff, Frances Jaeger, S Yogeshkumar, Parth Lalakia, Benjamin Leiby, Mita Majumdar, Amarjeet Mehta, Seema Mehta, Sudhir Mehta, Stephen T. Mennemeyer, Amit P. Revankar, Dharmesh Kumar Sharma, Vanessa Short, Manjunath S. Somannavar, Dennis Wallace, Hemang Shah, Manjula Singh, Sufia Askari, Mrutyunjaya B. Bellad, Savitri Bendigeri, Ashwini Dadapannavar, Veerabhadra Gurlapur, Geetanjali Mungarwadi, Clavia Pereira, Neha Sharma, Tahira Parveen, Jayshree Shekhawat, Trilochan Tripathi

Cognitive effectiveness of high-intensity interval training for individuals with methamphetamine dependence: a study protocol for randomised controlled trial

Shen Menglu, Yang Suyong, Wang Xiaoyan, Wolfgang I. Schöllhorn, Zhu Dong

Evaluating newly approved drugs for multidrug-resistant tuberculosis (endTB): study protocol for an adaptive, multi-country randomized controlled trial

L. Guglielmetti, E. Ardizzoni, M. Atger, E. Baudin, E. Berikova, M. Bonnet, E. Chang, S. Cloez, J. M. Coit, V. Cox, B. C. de Jong, C. Delifer, J. M. Do, D. Dos Santos Tozzi, V. Ducher, G. Ferlazzo, M. Gouillou, A. Khan, U. Khan, N. Lachenal, A. N. LaHood, L. Lecca, M. Mazmanian, H. McIlleron, M. Moschioni, K. O’Brien, O. Okunbor, L. Oyewusi, S. Panda, S. B. Patil, P. P. J. Phillips, L. Pichon, P. Rupasinghe, M. L. Rich, N. Saluhuddin, K. J. Seung, M. Tamirat, L. Trippa, M. Cellamare, G. E. Velásquez, S. Wasserman, P. J. Zimetbaum, F. Varaine, C. D. Mitnick

Acupuncture as adjunctive therapy for acute renal colic caused by urinary calculi: study protocol for a randomized controlled trial

Ying Cao, Jian-Feng Tu, Guang-Xia Shi, Li-Qiong Wang, Lian-Cheng Jia, Bo Li, Bao-Li Liu, Wei-Hai Yao, Xiao-Lu Pei, Zhi-Cheng Qu, Cun-Zhi Liu

The PRolaCT studies — a study protocol for a combined randomised clinical trial and observational cohort study design in prolactinoma

Ingrid M. Zandbergen, Amir H. Zamanipoor Najafabadi, Iris C. M. Pelsma, M. Elske van den Akker-van Marle, Peter H. L. T. Bisschop, H. D. Jeroen Boogaarts, Arianne C. van Bon, Bakhtyar Burhani, Saskia le Cessie, Olaf M. Dekkers, Madeleine L. Drent, Richard A. Feelders, Johan P. de Graaf, J. Hoogmoed, Kitty K. Kapiteijn, Melanie M. van der Klauw, Willy-Anne C. M. Nieuwlaat, Alberto M. Pereira, Aline M. E. Stades, Annenienke C. van de Ven, Iris M. M. J. Wakelkamp, Wouter R. van Furth, Nienke R. Biermasz

Use of routinely collected health data in randomised clinical trials: comparison of trial-specific death data in the BOSS trial with NHS Digital data

Sharon B. Love, Anna Kilanowski, Victoria Yorke-Edwards, Oliver Old, Hugh Barr, Clive Stokes, Catherine Kendall, Matthew R. Sydes

Comparison of effect of auriculotherapy and mefenamic acid on the severity and systemic symptoms of primary dysmenorrhea: a randomized clinical trial

Masoomeh Vahedi, Seyedeh Batool Hasanpoor-Azghady, Leila Amiri-Farahani, Imaneh Khaki

Effectiveness and cost-effectiveness of four different strategies for SARS-CoV-2 surveillance in the general population (CoV-Surv Study): study protocol for a two-factorial randomized controlled multi-arm trial with cluster sampling

Andreas Deckert, Simon Anders, Manuela De Allegri, Hoa Thi Nguyen, Aurélia Souares, Shannon McMahon, Matthias Meurer, Robin Burk, Matthias Sand, Lisa Koeppel, Lena Maier Hein, Tobias Roß, Tim Adler, Tobias Siems, Lucia Brugnara, Stephan Brenner, Konrad Herbst, Daniel Kirrmaier, Yuanqiang Duan, Svetlana Ovchinnikova, Kathleen Boerner, Michael Marx, Hans-Georg Kräusslich, Michael Knop, Till Bärnighausen, Claudia Denkinger

Study protocol: a multi-center, double-blind, randomized, 6-month, placebo-controlled trial to investigate the effect of supplementing hormone therapy FET cycles with Gushen’antai pills on the outcomes of in vitro fertilization

Ying-jie Ma, Xian-ling Cao, Ting Ma, Jing-yan Song, Ling-yu Yu, Yang-yang Yu, Jian-Yun Zhao, Zhen-Gao Sun

Women’s experiences of receiving information about and consenting or declining to participate in a randomized controlled trial involving episiotomy in vacuum-assisted delivery: a qualitative study

Jenny Ericson, Cecilia Anagrius, Agnes Rygaard, Lisa Guntram, Sophia Brismar Wendel, Susanne Hesselman

A pragmatic randomised controlled trial referring to a Personalised Self-management SUPport Programme (P-SUP) for persons enrolled in a disease management programme for type 2 diabetes mellitus and/or for coronary heart disease

Uwe Konerding, Marcus Redaèlli, Karolin Ackermann, Sibel Altin, Sebastian Appelbaum, Bianca Biallas, August-Wilhelm Bödecker, Suzan Botzenhardt, Chloé Chermette, Martin Cichocki, Iris Dapper, Katja Dehnen, Christian Funke, Angeli Gawlik, Lisa Giesen, Johannes Goetz, Christian Graf, Bernd Hagen, Martina Heßbrügge, Phillip Hendrick Höhne, Jens Kleinert, Helene Könnecke, Lucas Küppers, Nicole Kuth, Lion Lehmann, Claas Lendt, Khalid Majjouti, Yeliz Nacak, Aliza Neuhausen, Larisa Pilic, Lara Schneider, Maximilian Scholl, Dusan Simic, Andreas Sönnichsen, Anika Thielmann, Ines Van der Arend, Frank Vitinius, Birgitta Weltermann, Dorothea Wild, Stefan Wilm, Stephanie Stock

Natural vs. programmed cycles for frozen embryo transfer: study protocol for an investigator-initiated, randomized, controlled, multicenter clinical trial

Sheriza Baksh, Anne Casper, Mindy S. Christianson, Kate Devine, Kevin J. Doody, Stephan Ehrhardt, Karl R. Hansen, Ruth B. Lathi, Fatmata Timbo, Rebecca Usadi, Wendy Vitek, David M. Shade, James Segars, Valerie L. Baker, Lusine Aghajanova, Ruben Alvero, Mary Andrews, Diego Arevalo, Emily Barnard, Aracely Casillas, Morgan Copeland, La Tasha B. Craig, Kathleen M. Doody, Ashley Eskew, Alma Gonzalez, Gretchen Hoelscher, Arthur Jason Vaught, Lynda Kochman, Andie Lears, Gaya Murugappan, Anna C. Nackley, Tasha Newsome, Natalie Quintana, Bhuchitra Singh, Anna Sokalska, Michelle Starkey-Scruggs, Robin L. Thomas, Deveine Toney, Irene Trueheart, Kisha Turner, Rebecca Usadi, Sally Villalobos, Anjali Wignarajah, Virginia Winn, Christy Zones

Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial

Ruanne V. Barnabas, Elizabeth R. Brown, Maricianah Onono, Elizabeth A. Bukusi, Betty Njoroge, Rachel L. Winer, Deborah Donnell, Denise Galloway, Stephen Cherne, Kate Heller, Hannah Leingang, Susan Morrison, Elena Rechkina, R. Scott McClelland, Jared M. Baeten, Connie Celum, Nelly Mugo

The SToICAL trial: study protocol for the soft tissue injection of corticosteroid and local anaesthetic trial—a single site, non-inferiority randomised control trial evaluating pain after soft tissue corticosteroid injections with and without local anaesthetic

M. Jones, J. Evans, S. Fullilove, E. Doyle, C. Gozzard

Efficacy evaluation and mechanism study of electroacupuncture intervention in acute phase of IFP: study protocol for a randomized controlled trial

Yinan Qin, Lihong Yang, Man Zhang, Yang Bai, Zexin Li, Nana Zhao, Zhimei Li, Tianyu Xu, Yue Xie, Yuanhao Du

C-STICH: Cerclage Suture Type for an Insufficient Cervix and its effect on Health outcomes—a multicentre randomised controlled trial

Fidan Israfil-Bayli, Victoria Hodgetts Morton, Catherine A. Hewitt, Andrew K. Ewer, Jim Gray, Jane Norman, Christoph Lees, Nigel A. B. Simpson, Andrew Shennan, Konstantinos Tryposkiadis, Max Hughes, Jane Daniels, Peter Brocklehurst, Katie Morris, Lee Middleton, Philip Toozs-Hobson

Head-to-head comparison of sirolimus- versus paclitaxel-coated balloon angioplasty in the femoropopliteal artery: study protocol for the randomized controlled SIRONA trial

Ulf Teichgräber, Maja Ingwersen, Stephanie Platzer, Thomas Lehmann, Thomas Zeller, René Aschenbach, Dierk Scheinert

PRO B: evaluating the effect of an alarm-based patient-reported outcome monitoring compared with usual care in metastatic breast cancer patients—study protocol for a randomised controlled trial

Maria Margarete Karsten, Friedrich Kühn, Therese Pross, Jens-Uwe Blohmer, Anna Maria Hage, Felix Fischer, Matthias Rose, Ulrike Grittner, Pimrapat Gebert, Julia Ferencz, Luis Pauler, Clara Breidenbach, Christoph Kowalski, Gregor Matthesius, Jannis Seemann, Jennifer Lenz, Sophia Rocabado, Marlen Du Bois, Lars Straubing

Correction to: Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial

Marek Holy, Anna MacDowall, Freyr Gauti Sigmundsson, Claes Olerud

Correction to: Effects of a Brazilian cardioprotective diet and nuts on cardiometabolic parameters after myocardial infarction: study protocol for a randomized controlled clinical trial

Aline Marcadenti, Bernardete Weber, Angela Cristine Bersch-Ferreira, Rachel Helena Vieira Machado, Camila Ragne Torreglosa, Enilda Maria de Sousa Lara, Lucas Ribeiro da Silva, Renato Hideo Nakagawa Santos, Debora Harumi Kodama Miyada, Erica Regina Ribeiro Sady, Rosana Perim Costa, Leopoldo Piegas, Erlon Oliveira de Abreu-Silva, Alexandre Schaan de Quadros, Camila Weschenfelder, Júlia Lorenzon dos Santos, Gabriela Corrêa Souza, Suena Medeiros Parahiba, Ana Paula Trussardi Fayh, Danielle Soares Bezerra, Ana Paula Perillo Ferreira Carvalho, Malaine Morais Alves Machado, Sandra Mary Lima Vasconcelos, Jéssika Araújo, José Albuquerque de Figueiredo Neto, Luciana Pereira Pinto Dias, Francisca Eugenia Zaina Nagano, Cássia Cristina Paes de Almeida, Annie Seixas Bello Moreira, Débora Pinto Gapanowicz, Eduardo Purgatto, Marcelo Macedo Rogero, Geni Rodrigues Sampaio, Elizabeth Aparecida Ferraz da Silva Torres, Graziela Biude Silva Duarte, Alexandre Biasi Cavalcanti

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

Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial

Kelly M. A. Dreuning, Maurits W. van Tulder, Jasper V. Been, Maroeska M. Rovers, Jurgen C. de Graaff, Markus F. Stevens, Johannes R. Anema, Jos W. R. Twisk, L. W. Ernest van Heurn, Joep P. M. Derikx

Dupuytren’s interventions surgery versus collagenase (DISC) trial: study protocol for a pragmatic, two-arm parallel-group, non-inferiority randomised controlled trial

Joseph Dias, Catherine Arundel, Puvan Tharmanathan, Ada Keding, Charlie Welch, Belen Corbacho, Maria Armaou, Paul Leighton, Christopher Bainbridge, Michael Craigen, Lydia Flett, Samantha Gascoyne, Catherine Hewitt, Elaine James, Sophie James, Nick Johnson, Judy Jones, Catherine Knowlson, Priya Radia, David Torgerson, David Warwick, Michelle Watson

Correction to: Effect of Lycium barbarum polysaccharide supplementation in non-alcoholic fatty liver disease patients: study protocol for a randomized controlled trial

Lu-Lu Gao, Yu-Xiang Li, Jia-Min Ma, Yi-Qiong Guo, Lin Li, Qing-Han Gao, Yan-Na Fan, Meng-Wei Zhang, Xiu-Juan Tao, Jian-Qiang Yu, Jian-Jun Yang

Effects of modified-Paleo and moderate-carbohydrate diets on body composition, serum levels of hepatokines and adipocytokines, and flow cytometric analysis of endothelial microparticles in adults with metabolic syndrome: a study protocol for a randomized clinical trial

Farnoosh Shemirani, Akbar Fotouhi, Kurosh Djafarian, Leila Azadbakht, Nima Rezaei, Maryam Mahmoudi

A phase I/II dose-escalation multi-center study to evaluate the safety of infusion of natural killer cells or memory T cells as adoptive therapy in coronavirus pneumonia and/or lymphopenia: RELEASE study protocol

I. García-García, P. Guerra-García, C. Ferreras, A. M. Borobia, A. J. Carcas, J. Queiruga-Parada, J. L. Vicario, I. Mirones, C. Solano, C. Eguizabal, B. Soria, A. Pérez-Martínez