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Trials

Issue 1/2024

Content (858 Articles)

A prevention program for binge drinking among students based on mindfulness and implementation intention (ALCOMEDIIT): a randomized controlled trial

Jessica Mange, Nicolas Mauny, Charlotte Montcharmont, Eve Legrand, Maud Lemercier-Dugarin, Arnaud Mortier, Martin Duvivier, Johnny Leveneur, Cédric Lacherez, Nicolas Cabé, Anne-Pascale Le Berre

  • Open Access
  • Mpox
  • Research

Experiences and challenges with the new European Clinical Trials Regulation

Thale D. J. H. Patrick-Brown, Josephine Bourner, Sabrina Kali, Marius Trøseid, Yazdan Yazdanpanah, Piero Olliaro, Inge Christoffer Olsen

Dreaming during gastrointestinal endoscopy under propofol, ciprofol, or remimazolam anesthesia: study protocol for a parallel-design double-blind, single-center trial

Le-Qiang Xia, Rui Zhou, Rui Deng, Dan Zhou, Jia Han, Zhi-Fu Zhao, San-Jie Gao, Xian-Jie Zhang, Yu-Kai Zhou, Li-Ze Xiong

Efficacy and safety of heparin for sepsis-induced disseminated intravascular coagulation (HepSIC): study protocol for a multicenter randomized controlled trial

Yini Sun, Renyu Ding, Hao Sun, Yingjian Liang, Xiaochun Ma

  • Open Access
  • Research

Randomized study of two different consent procedures on recall: a study within a digital alcohol intervention trial

Katarina Ulfsdotter Gunnarsson, Elizabeth S. Collier, Jim McCambridge, Marcus Bendtsen

Efficacy of intraoperative irrigation with artificial cerebrospinal fluid in chronic subdural hematoma surgery: study protocol for a multicenter randomized controlled trial

Yoshitaka Nagashima, Yoshio Araki, Kazuki Nishida, Shunichiro Kuramitsu, Kenichi Wakabayashi, Shinji Shimato, Takeshi Kinkori, Toshihisa Nishizawa, Takahisa Kano, Toshinori Hasegawa, Atsushi Noda, Kenko Maeda, Yu Yamamoto, Osamu Suzuki, Naoki Koketsu, Takeshi Okada, Masashige Iwasaki, Kiyo Nakabayashi, Shigeru Fujitani, Hideki Maki, Yachiyo Kuwatsuka, Masahiro Nishihori, Takafumi Tanei, Tomohide Nishikawa, Yusuke Nishimura, Ryuta Saito, Satoshi Maesawa, Takashi Izumi, Kazuya Motomura, Eiji Ito, Eriko Okumura, Fumiharu Ohka, Kazuhito Takeuchi, Yuichi Nagata, Kinya Yokoyama, Tomotaka Ishizaki, Fumiaki Kanamori, Yutaro Fuse, Aya Sato, Seki Yukio, Tetsuya Nagatani, Yusuke Sakamoto, Kenji Uda, Tetsuya Tsukada, Takayuki Ishikawa, Hiroo Sasaki, Ienaga Jyunpei, Yosuke Sakai, Toru Watanabe, Yuichiro Isozawa, Nobuyasu Kato, Yasukazu Kajita, Noriyuki Suzaki, Kaoru Eguchi, Masashi Ito, Shunsaku Goto, Ryo Ando, Hayato Yokoyama, Kazuichi Terao, Naoto Kawaguchi, Yu Sugiyama, Hitofumi Oyama, Tomomi Kawaguchi, Takafumi Otsuka, Taiko Osada, Tomoki Matsuyama, Kengo Hirayama, Kouki Takeda, Shohei Mizuno, Kazuhiko Watanabe, Shigekazu Nakamura, Shinji Ota, Naoki Kato, Masahiro Ueno, Yusuke Sato, Masato Otawa, Mizuki Nakano, Yuhei Takido, Wataru Okada, Takashi Sakuma, Shun Yamamoto, Chihiro Iinuma, Takumi Asai, Yoshihiro Yamashita, Shinsuke Muraoka, Shigeaki Nawa, Hajime Hamasaki, Takahiko Fukui, Naoki Suzuki, Ikuo Takahashi, Ota Keisuke, Hirotada Kataoka, Yosuke Tamari, Tomoya Goto, Toshiki Seki, Tomiyuki Miyake, Takenori Kato, Takehiro Naito, Akihiro Mizuno, Yuta Koketsu, Takumi Otake, Akinori Kageyama, Hirotaka Niwa, Hiroyuki Oishi, Toshio Yokoe, Shuntaro Takasu, Masaya Takemoto, Jungsu Choo, Mizuka Ikezawa, Fumihiro Sago, Daiki Somiya, Mizuki Terano, Kohei Doba, Daimon Shiraishi, Sho Akahori, Motonori Ishii, Nobuhisa Fukaya, Toshiki Fukuoka, Takayuki Awaya, Shoko Wakisaka, Masao Tambara, Hiroyuki Shimizu, Satoshi Shinoda, Yusuke Muramatsu, Otone Endo, Kentaro Fujii, Yiichi Kawasaki, Takato Ono, Kento Hirayama, Yuya Itagaki, Shuya Kurono, Jyunzo Ishiyama, Chihiro Aoshima, Yuki Sunohara, Yuri Aimi, Mitsuhiro Yoshida, Mamoru Ishida, Masayuki Kimata, Hisashi Mizutani, Kenichi Hattori, Kentaro Wada, Takashi Mamiya, Masahiro Wakabayashi, Toshiaki Hirose, Risa Ito, Yusuke Ota, Hiroaki Kubo, Tomoyuki Noda, Teppei Kawabata, Tasuku Imai, Takahiro Oyama, Kei Hachiya, Yasumasa Nishida

Comparison between the mesenteric fixation method (MEFIX) and conventional methods at preventing the occurrence of Petersen’s hernia: a study protocol for a multicenter randomized controlled trial

Jae Kyun Park, Dae Hwan Kim, Tae-Yong Jeon, Sang-Ho Jeong, Tae Han Kim, Jae-Seok Min, Rock Bum Kim, Young Joon Lee, Ji Ho Park, Young Gil Son, Ki Young Yoon, Kyung Won Seo, Ki Hyun Kim, Yoonhong Kim, Hyun Dong Chae, Sun Hwi Hwang, Si-Hak Lee, Jae Hun Chung, Hyoung-Il Kim, Dong Jin Park, Kwang Hee Kim, Sang Hyuk Seo, Sung Jin Oh, Woo Yong Lee, Chang In Choi

  • Open Access
  • Study protocol

PeRsOnaliSed care Planning for oldER people with frailty (PROSPER): protocol for a randomised controlled trial

Anne Heaven, Peter Bower, Florence Day, Amanda Farrin, Catherine Fernadez, Marilyn Foster, Robbie Foy, Rebecca Hawkins, Claire Hulme, Sara Humphrey, Rebecca Lawton, Catriona Parker, Ellen Thompson, Robert West, Andrew Clegg

  • Open Access
  • Study protocol

Clinical study protocol on electronic cigarettes and nicotine pouches for smoking cessation in Pakistan: a randomized controlled trial

Abdul Hameed, Daud Malik

Ultrasound-guided erector spinae plane block for perioperative analgesia in patients undergoing laparoscopic nephrectomies surgery: a randomized controlled trial

Ming Yang, Lei Cao, Tong Lu, Cheng Xiao, Zhuoxi Wu, Xuetao Jiang, Wei Wang, Hong Li

  • Open Access
  • Study protocol

Using hypnotic suggestion in the rehabilitation of working memory capacity after acquired brain injury: study protocol for a randomized controlled trial

Line Sophie Eide, Per-Ola Rike, Silje Endresen Reme, Hildegun Snekkevik, Stephan Rossner, Gunnar Rosen, Jonas Kristoffer Lindeløv, Marianne Løvstad

  • Open Access
  • Keloid
  • Study protocol

A randomised clinical trial study assessing the efficacy of 5% losartan potassium loaded in ethosomal gel to treat human keloids: a trial protocol

Yuni Eka Anggraini, Niken Trisnowati, Ronny Martien, Retno Danarti

  • Open Access
  • Anxiety
  • Study protocol

Internet-based transdiagnostic treatment for emotional disorders in Arabic- and Farsi-speaking refugees: study protocol of a randomized controlled trial

Johanna Boettcher, Manuel Heinrich, Maria Boettche, Sebastian Burchert, Heide Glaesmer, Euphrosyne Gouzoulis-Mayfrank, Carina Heeke, Martina Hernek, Christine Knaevelsrud, Alexander Konnopka, Louisa Muntendorf, Hannah Nilles, Laura Nohr, Steffi Pohl, Sophia Paskuy, Isabelle Reinhardt, Susan Sierau, Nadine Stammel, Christina Wirz, Babette Renneberg, Birgit Wagner

  • Open Access
  • Study protocol

Preoperative supine time for adrenal venous sampling: a prospective randomized controlled trial

Minzhi He, Yuhao Zhang, Xiaoxiao Song, Tianyue Zhang, Hailan Yu, Yongli Ji, Siyuan Gong, Peifei Chai, Jinyi Chen, Siwei Wang, Bing Chen, Xiaohong Xu, Zhenjie Liu

  • Open Access
  • Suicide
  • Study protocol

Adjunctive duration-doubled transcranial direct current stimulation for the treatment of depressive patients with suicidal ideation: study protocol for a double-blind, randomized, sham-controlled trial

Yiming Chen, Dongbin Lyu, Fan Wang, Qinte Huang, Weichieh Yang, Mengke Zhang, Zheyi Wei, Shuxiang Shi, Shuqi Kong, Shentse Chen, Shuang He, Vivien Yang, Yiru Fang, Abdel Douiri, Wu Hong

A randomized, controlled clinical study of low-molecular-weight heparin improving pregnancy outcomes in PCOS women undergoing IVF: study protocol

Ou Huang, Haixia Ding, Dandan Wu, Qing Zhang, Wen Li

Endovascular aortic repair with sac embolization for the prevention of type II endoleaks (the EVAR-SE study): study protocol for a randomized controlled multicentre study in Germany

Christoph Knappich, Felix Kirchhoff, Marie-Kristin Fritsche, Silvia Egert-Schwender, Heiko Wendorff, Michael Kallmayer, Bernhard Haller, Alexander Hyhlik-Duerr, Christian Reeps, Hans-Henning Eckstein, Matthias Trenner

Correction: Clinical and cost-effectiveness of a New psychosocial intervention to support Independence in Dementia (NIDUS-family) for family carers and people living with dementia in their own homes: a randomised controlled trial

Alexandra Burton, Penny Rapaport, Marina Palomo, Kathryn Lord, Jessica Budgett, Julie Barber, Rachael Hunter, Laurie Butler, Victoria Vickerstaff, Kenneth Rockwood, Margaret Ogden, Debs Smith, Iain Lang, Gill Livingston, Briony Dow, Helen Kales, Jill Manthorpe, Kate Walters, Juanita Hoe, Vasiliki Orgeta, Quincy Samus, Claudia Cooper

  • Open Access
  • Study protocol

Effects of individualized positive end-expiratory pressure on intraoperative oxygenation in thoracic surgical patients: study protocol for a prospective randomized controlled trial

Xu-Ming Liu, Xin-Lu Chang, Jing-Yi Sun, Wen-Wen Hao, Li-Xin An

ERASURE: early autologous blood pleurodesis for postoperative air leaks—a randomized, controlled trial comparing prophylactic autologous blood pleurodesis versus standard watch and wait treatment for postoperative air leaks following thoracoscopic anatomic lung resections

Ioannis Karampinis, Christian Ruckes, Fabian Doerr, Servet Bölükbas, Sara Ricciardi, Giuseppe Cardillo, Carlos Galvez, Bogdan Vidmar, Tomaz Stupnik, Vincent Fang, Rene Horsleben Petersen, Eric Dominic Roessner

HYPofractionated Adjuvant RadioTherapy in 1 versus 2 weeks in high-risk patients with breast cancer (HYPART): a non-inferiority, open-label, phase III randomised trial

Budhi Singh Yadav, Divya Dahiya, P. Kannan, Shikha Goyal, Ishita Laroiya, Santhosh Irrinki, Ngangom Robert Singh, Reena Sharma

Effectiveness of peer-led intervention in control of non-communicable diseases in rural areas of Khordha district: study protocol for a cluster randomized controlled trial

Priyamadhaba Behera, Binod Kumar Patro, Arvind Kumar Singh, Susmita Dora, Debapriya Bandhopadhyay, Gautom Kumar Saharia, Anupam Dey, Surama Manjari Behera, Sonu H. Subba

  • Open Access
  • Study protocol

Protocol of a monocentric, double-blind, randomized, superiority, controlled trial evaluating the effect of in-prison OROS-methylphenidate vs. placebo treatment in detained people with attention-deficit hyperactivity disorder (BATIR)

Stéphanie Baggio, Joël Billieux, Anja Dirkzwager, Katia Iglesias, Karine Moschetti, Nader Perroud, Marie Schneider, Nathalie Vernaz, Hans Wolff, Patrick Heller

Comparison of the effects of esketamine, sufentanil, or lidocaine combined with propofol on tussis reflection during upper gastrointestinal endoscopy: study protocol for a randomised, two centre, three-blind, controlled trial

Hai-jun Hou, Lu Liu, Ming Tian, Fu-shan Xue

Entecavir versus tenofovir for prevention of hepatitis B virus-associated hepatocellular carcinoma after curative resection: study protocol for a randomized, open-label trial

Li-Xin Pan, Yi-Yang Wang, Zhong-Hai Li, Jia-Xi Luo, Kun-Jun Wu, Zhen-Xiu Liu, Pei-Sheng Wu, Kang Chen, Liang Ma, Xiao-Hui Fan, Jian-Hong Zhong

Effects of including a dog on treatment motivation and the therapeutic alliance in child and adolescent psychotherapy: study protocol for a randomized controlled trial

Wanda Arnskötter, Suzanne Martin, Susanne Walitza, Karin Hediger

Vitamin E-enriched medium cross-linked polyethylene in total knee arthroplasty (VIKEP): clinical outcome, oxidation profile, and wear analysis in comparison to standard polyethylene—study protocol for a randomized controlled trial

Kristin Maier, Marius Selig, Andréa Haddouche, Martin Haunschild, Oliver Hauschild, Iman Khalili, Julia Kirschberg, Christoph Lutter, Michael Menges, Patrice Mertl, Andreas Niemeier, Brice Rubens-Duval, Wolfram Mittelmeier

  • Open Access
  • Study protocol

Improving access to family planning for women with disabilities in Kaduna city, Nigeria: study protocol for a pragmatic cluster-randomized controlled trial with integrated process evaluation

Sarah Marks, Ekundayo Arogundade, Mark T. Carew, Shanquan Chen, Lena Morgon Banks, Hannah Kuper, Femi Adegoke, Calum Davey

Update of statistical analysis plan for: Integration of smoking cessation into standard treatment for patients receiving opioid agonist therapy who are smoking tobacco: protocol for a randomised controlled trial (ATLAS4LAR)

Karl Trygve Druckrey-Fiskaaen, Tesfaye Madebo, Jan Tore Daltveit, Jørn Henrik Vold, Einar Furulund, Torgeir Gilje Lid, Lars Thore Fadnes

Nutritional treatment of children 6–59 months with severely low weight-for-age z-score: a study protocol for a 3-arm randomized controlled trial

Suvi T. Kangas, Césaire T. Ouédraogo, Moctar Tounkara, Bareye Ouoluoguem, Issa Niamanto Coulibaly, Alhousseyni Haidara, Niele Hawa Diarra, Koniba Diassana, Zachary Tausanovitch, Christian Ritz, Jonathan C. Wells, André Briend, Mark Myatt, Elizabeth Radin, Jeanette Bailey

Autogenic splenic implantation versus splenectomy in patients undergoing distal pancreatectomy for benign or low-grade malignant lesions of the distal pancreas: study protocol for a multicentre, open-label, randomized controlled trial (RESTORE)

Mohammed Abu Hilal, Christoph Kuemmerli, Jasper P. Sijberden, Alma Moekotte, Giuseppe Zimmitti, Adnan Alseidi, Horacio J. Asbun, Ravi Marudanayagam, Morgan Bonds, Filipe Kunzler, Robert Sutcliffe, Efrem Eren, John N. Primrose, Anthony P. Williams

  • Open Access
  • Study protocol

InterVFast—effectiveness and acceptance of intermittent fasting in cardiac rehabilitation patients: study protocol of a randomized controlled trial

Claudia Pieper, Florian Tim Hitesh Kaistha, Sarah Schroeer, Maria Borgert, Andreas Michalsen, Wolfgang Mayer-Berger

The effect of carotid sinus neurectomy for carotid restenosis: a study protocol for a double-blinded and randomized controlled trial

Zhi Zhang, Xiang Ji, Yihao Tao, Ning Huang, Rong Wen, Jun Tang, Yuan Cheng, Zongyi Xie, Guodong Liu, Guanjian Zhao

Determining the effects of targeted high-definition transcranial direct current stimulation on reducing post-stroke upper limb motor impairments—a randomized cross-over study

Rita Huan-Ting Peng, Dorothy He, Shirley A. James, Jordan N. Williamson, Carly Skadden, Sanjiv Jain, Wael Hassaneen, Amrendra Miranpuri, Amandeep Kaur, Jesus N. Sarol, Yuan Yang

Statistical analysis plan for the multicenter, open, randomized controlled clinical trial to assess the efficacy and safety of intravenous tirofiban vs aspirin in acute ischemic stroke due to tandem lesion, undergoing recanalization therapy by endovascular treatment (ATILA trial)

Elena Zapata-Arriaza, Manuel Medina-Rodríguez, Francisco Moniche Álvarez, Asier de Albóniga-Chindurza, Marta Aguilar-Pérez, Leire Ainz-Gómez, Pablo Baena-Palomino, Aynara Zamora, Blanca Pardo-Galiana, Fernando Delgado-Acosta, Roberto Valverde Moyano, Elvira Jiménez-Gómez, Isabel Bravo Rey, Rafael Oteros Fernández, Irene Escudero-Martínez, Isabel Vielba-Gomez, Lluis Morales Caba, Jose Díaz Pérez, Estefania García Molina, Sonia Mosteiro, María del Mar Castellanos Rodrigo, Laura Amaya Pascasio, Carlos Hidalgo, María del Mar Freijo Guerrero, Eva González Díaz, Jose María Ramírez Moreno, Luis Fernández Prudencio, Mikel Terceño Izaga, Saima Bashir Viturro, Miguel Ángel Gamero-García, Silvia Jiménez Jorge, Clara Rosso Fernández, Joan Montaner, Alejandro González García

  • Open Access
  • Correction

Correction: Examining the impact of a universal social and emotional learning intervention (Passport) on internalising symptoms and other outcomes among children, compared to the usual school curriculum: study protocol for a school-based cluster randomised trial

Annie O’Brien, Suzanne Hamilton, Neil Humphrey, Pamela Qualter, Jan R. Boehnke, Joao Santos, Ola Demkowicz, Margarita Panayiotou, Alex Thompson, Jennifer Lau, Lauren Burke, Yizhuo Lu

Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial

Dheeraj Rai, Doug Webb, Amanda Lewis, Leonora Cotton, Jade Eloise Norris, Regi Alexander, David S. Baldwin, Traolach Brugha, Madeleine Cochrane, Maria Chiara Del Piccolo, Emma J. Glasson, Katherine K. Hatch, David Kessler, Peter E. Langdon, Helen Leonard, Stephanie J. MacNeill, Nicola Mills, Maximiliano Vazquez Morales, Zoe Morgan, Raja Mukherjee, Alba X. Realpe, Ailsa Russell, Sergio Starkstein, Jodi Taylor, Nicholas Turner, Joanna Thorn, Jack Welch, Sarah Douglas, Peter Hale, Sarah O’Brien, Amy Walker, Nicola Wiles

  • Open Access
  • ICSI
  • Study protocol

Personalizing the first dose of FSH for IVF/ICSI patients through machine learning: a non-inferiority study protocol for a multi-center randomized controlled trial

Nuria Correa, Jesus Cerquides, Josep Lluis Arcos, Rita Vassena, Mina Popovic

Delivering COVID-19 vaccine trials at speed: the implementation of a phase IV UK multi-centre randomised controlled trial to determine safety and immunogenicity of COVID-19 vaccines co-administered with seasonal influenza vaccines (ComFluCOV)

Sarah Baos, Rachel Todd, Russell Thirard, Rosie Harris, Jana Kirwan, Katherine Joyce, David Hutton, Adam Finn, Madeleine Clout, Heike Cappel-Porter, Chris A Rogers, Rajeka Lazarus, Lucy Culliford

Effectiveness of a blended school-based mindfulness program for the prevention of co-rumination and internalizing problems in Dutch secondary school girls: a cluster randomized controlled trial

Patricia Vuijk, Kim Bul, Marieke Buil, Marloes Rauws, Keshia Curie, Charlotte Amesz, Ron Weerheijm, Heleen Riper

Prophylactic Radiotherapy Of MInimally Symptomatic Spinal Disease (PROMISSeD): study protocol for a randomized controlled trial

Robert J. Rothrock, Ahmad Ozair, Maria C. Avendano, Susana Herrera, Haley Appel, Suyen Ramos, Amy K. Starosciak, Daniel S. Leon-Ariza, Muni Rubens, Michael W. McDermott, Manmeet S. Ahluwalia, Minesh P. Mehta, Rupesh R. Kotecha

Efficacy of navigation system-assisted distraction osteogenesis for hemifacial microsomia based on artificial intelligence for 3 to 18 years old: study protocol for a randomized controlled single-blind trial

Xiangqi Liu, Ziwei Zhang, Wenqing Han, Zhijie Zhao, Byeong Seop Kim, Yingjie Yan, Xiaojun Chen, Xuetong Wang, Xin Li, Xianxian Yang, Bingshun Wang, Haisong Xu, Li Lin, Gang Chai

Personalized exposure and experience sampling method feedback versus exposure as usual for obsessive–compulsive disorder: a study protocol for a randomized controlled trial

Elena Hoogerwerf, Anja Greeven, Rutger Goekoop, Philip Spinhoven

Active versus sham DLPFC-NAc rTMS for depressed adolescents with anhedonia using resting-state functional magnetic resonance imaging (fMRI): a study protocol for a randomized placebo-controlled trial

Runxin Lv, Min Cai, Nailong Tang, Yifan Shi, Yuyu Zhang, Nian Liu, Tianle Han, Yaochi Zhang, Huaning Wang

Initial treatment with a single capsule containing half-dose quadruple therapy versus standard-dose dual therapy in hypertensive patients (QUADUAL): statistical analysis plan for a randomized, blinded, crossover trial

Xiexiong Zhao, Xingli Li, Tao Liu, Guoping Yang, Ye Chen, Miao Huang, Lin Zhao, Xiaogang Li, Weihong Jiang

Impact evaluation of a maternal and child cash transfer intervention, integrated with nutrition, early childhood development, and agriculture messaging (MAZIKO-IE): a study protocol for a cluster-randomised controlled trial

Aulo Gelli, Jan Duchoslav, Melissa Gladstone, Daniel Gilligan, Mangani Katundu, Ken Maleta, Agnes Quisumbing, Lilia Bliznashka, Marilyn Ahun

A nitrous oxide/oxygen fixed mixture to reduce pain induced by the hypodermic injection: study protocol for a randomized, controlled trial

Jun-Jun Zhang, Ping Yu, Hui Dang, Cheng-Shuang Feng, Xiu-Jiang Long, Wen-Fa Huang, Lei Wang, Jie-Ling Li, Guo-Liang Tian, Jia-Quan Wen, Jun-Hui Mei, Yu-Xiang Li

  • Open Access
  • Laser
  • Study protocol

Efficacy and safety of early YAG laser vitreolysis for symptomatic vitreous floaters: the study protocol for a randomized clinical trial

Zhou Hangshuai, Jin Yanhua, Zhou Yao, Zhao Guangjin, Wu Hongyan, Chen Fanlian

Precutting endoscopic band ligation-assisted resection versus endoscopic submucosal dissection in patients with small gastric submucosal tumors originating from the muscularis propria: study protocol of a randomized controlled trial

Mingfeng Liu, Rui Yuan, Ke Zhan, Yichun Yang, Shan Li, Liang Deng

CompARE: study protocol for a phase III randomised controlled platform trial comparing alternative regimens for escalating treatment of intermediate and high-risk oropharyngeal cancer

Hisham Mehanna, Piers Gaunt, Anthony Kong, Andrew Hartley, Paul Sanghera, Martin Forster, Mehmet Sen, Vinidh Paleri, Charles Fong, Dinos Geropantas, Devraj Srinivasan, Satya Garikipati, Rafael Moleron, Georgina Casswell, Eleanor Aynsley, Amy Ward, Lorcan O’Toole, Arafat Mirza, Charlotte Firth, Isla Humphreys, Tessa Fulton-Lieuw, Tom Roques, Paul Nankivell

Effect of ultrasound-guided continuous erector spinae plane block on postoperative pain and inflammatory response in patients undergoing modified radical mastectomy for breast cancer: study protocol for a randomised controlled trial

Liang Yu, Xiao-Juan Shen, He Liu, Yu-Ting Zhou, Qin Zhang, Zhen-Duo Zhang, Shu-Min Shen

Early tirofiban versus heparin for bridging dual antiplatelet therapy in patients undergoing coronary endarterectomy combined with coronary artery bypass grafting: a multicenter randomized controlled trial protocol (the THACE-CABG trial)

Liang Chen, Ming-Xin Gao, Xin Du, Chi Wang, Wen-Yuan Yu, Hong-Li Liu, Xiao-Hang Ding, Bo-Lin Wang, Kui Zhang, Dong Xu, Zhen Han, Bao-Dong Xie, Ran Dong, Yang Yu

  • Open Access
  • Study protocol

Comparison of hemostatic ability between spray coagulation and forced coagulation modes in endoscopic submucosal dissection in patients with early gastric neoplasms: a study protocol for multicenter randomized controlled trial (Spray-G trial)

Kosuke Maehara, Mitsuru Esaki, Yorinobu Sumida, Daisuke Yamaguchi, Kei Nishioka, Hitoshi Homma, Taisuke Inada, Kazuo Shiotsuki, Shin-Ichiro Fukuda, Hirotada Akiho, Tadahiro Nomura, Yumi Mizuta, Satoshi Ishida, Shun Fujimoto, Shunichiro Kimura, Yuichiro Tanaka, Kaori Hata, Noriko Shiga, Tsutomu Iwasa, Yusuke Kimura, Norimoto Nakamura, Yusuke Suzuki, Yosuke Minoda, Yoshitaka Hata, Haruei Ogino, Koshiro Tagawa, Eikichi Ihara, Yoshihiro Ogawa

  • Open Access
  • Study protocol

The Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) for serious mental illness in community mental health part 3: study protocol to evaluate sustainment in a hybrid type 2 effectiveness-implementation cluster-randomized trial

Laurel D. Sarfan, Emma R. Agnew, Marlen Diaz, Ashby Cogan, Julia M. Spencer, Rafael Esteva Hache, Shannon Wiltsey Stirman, Cara C. Lewis, Amy M. Kilbourne, Allison G. Harvey

Efficacy of a 2-week therapy with levofloxacin concomitant versus a levofloxacin sequential regimen for Helicobacter pylori infection in the Syrian population: a study protocol for randomized controlled trial

Marouf Alhalabi, Rasha Almokdad

The Meteoritics Trial: efficacy of methotrexate after remission-induction with tocilizumab and glucocorticoids in giant cell arteritis—study protocol for a randomized, double-blind, placebo-controlled, parallel-group phase II study

Lena Kreis, Christian Dejaco, Wolfgang Andreas Schmidt, Robert Németh, Nils Venhoff, Valentin Sebastian Schäfer

The efficacy of a transdiagnostic sleep intervention for outpatients with sleep problems and depression, bipolar disorder, or attention deficit disorder: study protocol for a randomized controlled trial

Mette Kragh, Henny Dyrberg, Maria Speed, Pernille Pedersen, Sanne Toft Kristiansen, Klaus Martiny

  • Open Access
  • Research

Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET

Simron Singh, Diego Ferone, Jaume Capdevila, Jennifer Ang Chan, Wouter W. de Herder, Daniel Halperin, Josh Mailman, Lisa Hellström, Hanna Liedman, Agneta Svedberg, Fredrik Tiberg

The effects of cool roofs on health, environmental, and economic outcomes in rural Africa: study protocol for a community-based cluster randomized controlled trial

Aditi Bunker, Guillaume Compoaré, Maquins Odhiambo Sewe, Jose Guillermo Cedeno Laurent, Pascal Zabré, Valentin Boudo, Windpanga Aristide Ouédraogo, Lucienne Ouermi, Susan T. Jackson, Nicholas Arisco, Govind Vijayakumar, Ferhat Baran Yildirim, Sandra Barteit, Martina Anna Maggioni, Alistair Woodward, Jonathan J. Buonocore, Mekdim Dereje Regassa, Tilman Brück, Ali Sié, Till Bärnighausen

Evaluation of the efficiency of nanomicellar formulation of fat-soluble vitamins in patients with cystic fibrosis: the study protocol for a randomized controlled trial

Mahsa Soleimanzadeh, Saeedeh Talebi, Mahmoud Reza Jaafari, Seyed Javad Sayedi, Maryam Emadzadeh, Hamid Reza Kianifar

Tacrolimus versus mycophenolate for AutoImmune hepatitis patients with incompLete response On first-line therapy (TAILOR study): a study protocol for a phase III, open-label, multicentre, randomised controlled trial

Anna E. C. Stoelinga, Maarten E. Tushuizen, Wilbert B. van den Hout, Mar D. M. Rodriguez Girondo, Elsemieke S. de Vries, Amar D. Levens, Dirk-Jan A. R. Moes, Tom J. G. Gevers, Suzanne van der Meer, Hans T. Brouwer, Hendrik J. M. de Jonge, Ynte S. de Boer, Ulrich H. W. Beuers, Adriaan J. van der Meer, Aad P. van den Berg, Maureen M. J. Guichelaar, Joost P. H. Drenth, Bart van Hoek, Sjoerd F. Bakker, JM Vrolijk, Patrick van der Veek, Nicole F. van Gerven

Statistical analysis plan for a cluster randomised controlled trial to compare screening, feedback and intervention for child anxiety problems to usual school practice: identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i)

Susan Ball, Tessa Reardon, Cathy Creswell, Lucy Taylor, Paul Brown, Tamsin Ford, Alastair Gray, Claire Hill, Bec Jasper, Michael Larkin, Ian Macdonald, Fran Morgan, Jack Pollard, Michelle Sancho, Falko F. Sniehotta, Susan H. Spence, Jason Stainer, Paul Stallard, Mara Violato, Obioha C. Ukoumunne

The prevention of rectovaginal fistula after rectal cancer surgery by packing with laparoscopic dislocated fat flap containing ovarian vascular pedicle anterior to the anastomotic stoma: a parallel group randomized controlled trial protocol

Dao-xiong Ye, Sheng-hui Huang, Yu Lin, Ying-Huang, Pan Chi

Effects of small-dose S-ketamine on anesthesia-induced atelectasis in patients undergoing general anesthesia accessed by lung ultrasound: study protocol for a randomized, double-blinded controlled trial

Di Zhang, Yi Liang, Di Bao, Wei Xiong, Lu Li, Yaxin Wang, Bin Liu, Xu Jin

Efficacy of ultrasound-guided erector spinae plane block on analgesia and quality of recovery after minimally invasive direct coronary artery bypass surgery: protocol for a randomized controlled trial

Ling Xin, Lu Wang, Yi Feng

Robotic versus Electromagnetic bronchoscopy for pulmonary LesIon AssessmeNT: the RELIANT pragmatic randomized trial

Rafael Paez, Robert J. Lentz, Cristina Salmon, Justin K. Siemann, See-Wei Low, Jonathan D. Casey, Heidi Chen, Sheau-Chiann Chen, Sameer Avasarala, Samira Shojaee, Otis B. Rickman, Christopher J. Lindsell, Cheryl L. Gatto, Todd W. Rice, Fabien Maldonado

Optimizing the use of ketamine to reduce chronic postsurgical pain in women undergoing mastectomy for oncologic indication: study protocol for the KALPAS multicenter randomized controlled trial

Jing Wang, Lisa V. Doan, Deborah Axelrod, John Rotrosen, Binhuan Wang, Hyung G. Park, Robert R. Edwards, Michele Curatolo, Carina Jackman, Raven Perez

The clinical trial of alternative relugolix administration for uterine leiomyoma prior to surgically treatment: a study protocol for Non-Adverse Relugolix Administration (NARA) trial

Naoki Kawahara, Ryuji Kawaguchi, Konosuke Yamamoto, Kyohei Nishikawa, Motoki Matsuoka, Tomoka Maehana, Yosuke Fukui, Shoichiro Yamanaka, Sumire Sugimoto, Kana Iwai, Yuki Yamada, Hiroyuki Kurakami, Takumi Hirata, Ryuzo Takashima, Shota Suzuki, Kiyoshi Asada, Masato Kasahara, Fuminori Kimura

Broad-spectrum antibiotic prophylaxis in tumor and infected orthopedic surgery—the prospective-randomized, microbiologist-blinded, stratified, superiority trials: BAPTIST Trials

Ilker Uçkay, Hagen Bomberg, Markus Risch, Daniel Müller, Michael Betz, Mazda Farshad

Quabodepistat in combination with delamanid and bedaquiline in participants with drug-susceptible pulmonary tuberculosis: protocol for a multicenter, phase 2b/c, open-label, randomized, dose-finding trial to evaluate safety and efficacy

Rodney Dawson, Andreas H. Diacon, Simbarashe Takuva, Yongge Liu, Bo Zheng, Vatsala Karwe, Jeffrey Hafkin

Increasing transcultural competence in clinical psychologists through a web-based training: study protocol for a randomized controlled trial

Selina Studer, Maria Kleinstäuber, Ulrike von Lersner, Cornelia Weise

Study protocol for a randomised cross-over trial of Neurally adjusted ventilatory Assist for Neonates with Congenital diaphragmatic hernias: the NAN-C study

Grace Poole, Christopher Harris, Sandeep Shetty, Theodore Dassios, Allan Jenkinson, Anne Greenough

Effect of maternal oxygen supplementation for parturient undergoing elective cesarean section by high-flow nasal oxygen compared with room air on fetal acidemia: study protocol for a randomized controlled trial

Yun-Hui Li, Gui-Yu Lei, Jun Guo, Meng Yi, Yu-Jing Fu, Gu-Yan Wang

  • Open Access
  • Study protocol

Thoracic paravertebral block for perioperative lung preservation during VATS pulmonary surgery: study protocol of a randomized clinical trial

Jiayu Zhu, Biyu Wei, Lili Wu, He Li, Yi Zhang, Jinfeng Lu, Shaofei Su, Chunhua Xi, Wei Liu, Guyan Wang

  • Open Access
  • Study protocol

Bathing Adaptations in the Homes of Older Adults (BATH-OUT-2): study protocol for a randomised controlled trial, economic evaluation and process evaluation

Phillip J. Whitehead, Stuart Belshaw, Samantha Brady, Elizabeth Coleman, Alexandra Dean, Laura Doherty, Caroline Fairhurst, Sandra Francis-Farrell, Miriam Golding-Day, Joanne Gray, Maisie Martland, Jennifer McAnuff, Andrew McCarthy, Peter McMeekin, Natasha Mitchell, Melanie Narayanasamy, Craig Newman, Adwoa Parker, Tim Rapley, Sara Rodgers, Leigh Rooney, Rachel Russell, Laura Sheard, David Torgerson

A physiotherapy group exercise and self-management approach to improve physical activity in people with mild-moderate Parkinson’s disease: a randomized controlled trial

Sandra G. Brauer, Robyn M. Lamont, John D. O’Sullivan

Efficacy and safety of azvudine in symptomatic adult COVID-19 participants who are at increased risk of progressing to critical illness: a study protocol for a multicentre randomized double-blind placebo-controlled phase III trial

Xinlun Tian, Yan Xu, Luo Wang, Chongya Dong, Xiaoyan Yan, Junping Fan, Huaiya Xie, Hong Zhang, Jinglan Wang, Yongjian Liu, Yaqi Wang, Siqi Pan, Aohua Wu, Xueqi Liu, Chen Yao, Mengzhao Wang

Statistical analysis plan for the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke randomised controlled clinical trial

Monique F. Kilkenny, Muideen T. Olaiya, Janette Cameron, Natasha A. Lannin, Nadine E. Andrew, Amanda G. Thrift, Maree Hackett, Ian Kneebone, Avril Drummond, Vincent Thijs, Olivia Brancatisano, Joosup Kim, Megan Reyneke, Shaun Hancock, Liam Allan, Fiona Ellery, Geoffrey Cloud, Rohan S. Grimley, Sandy Middleton, Dominique A. Cadilhac, Dominique Cadilhac, Natasha Lannin, Helen Dewey, Monique Kilkenny, Nadine Andrew, Ian Kneebone, Avril Drummond, Jan Cameron, Amanda Thrift, Maree Hackett, Christopher Levi, Mariko Carey, Geoff Cloud, Rohan S. Grimley, Sandy Middleton, Vincent Thijs, Toni Aslett, Jonathon Li, Ernest Butler, Henry Ma, Pamela Galindo, Mark Gocotano, Andrea Moore, Fides Camino, Lily Murphy, Michael Teodoro, Bronwyn Coulton, Louise Lee, Philip Choi, Claire Buchanan, Tessa Busch, Darshan Ghia, Phoebe Lee, Gillian Edmonds, Rowena Singkang, Berzenn Urbi, Nicola Hall, Marie Matanas, Rebecca Danton, Natasha Bonanno, Kylie Tastula, Erin Li, Lucy Nolan, Timothy Kleinig, Jennifer Cranefield, Rajesh Khanna, Kirsty Page, Disha Patel, Kelly Jones, Sarah Dennien, Donna Rowley, Suzanne McGufficke, Rohan S. Grimley, Muideen Olaiya, Jonathan Li, Rebecca Barnden, Amanda Elston, Tara Purvis, Graeme Hankey, Leonid Churilov, Geoff Donnan, Coralie English, Jan Cameron, Olivia Brancatisano, Dawn Harris, Megan Reyneke, Lana Coleman, Tharshanah Thayabaranathan, Sue Mosely, Shaun Hancock, Oluwatobi Afolabi, Verena Schadewaldt, Toni Withiel, Fiona Ellery, Toni Aslett, Lisa Murphy, Eleanor Horton, Brenda Booth, Ida Dempsey

Working under short timescales to deliver a national trial: a case study of the ComFluCOV trial from a statistician’s perspective

Rosie Harris, Russell Thirard, Sarah Baos, Rajeka Lazarus, Rachel Todd, Jana Kirwan, Katherine Joyce, David Hutton, Maddie Clout, Heike Cappel-Porter, Lucy Culliford, Chris A. Rogers

  • Open Access
  • Commentary

Pragmatic randomized controlled trials: strengthening the concept through a robust international collaborative network: PRIME-9—Pragmatic Research and Innovation through Multinational Experimentation

Elmir Omerovic, Mark Petrie, Björn Redfors, Stephen Fremes, Gavin Murphy, Guillaume Marquis-Gravel, Alexandra Lansky, Eric Velazquez, Divaka Perera, Christopher Reid, Julian Smith, Peter van der Meer, Eric Lipsic, Peter Juni, John McMurray, Johann Bauersachs, Lars Køber, Jean L. Rouleau, Torsten Doenst

Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Corinna Engel, Mario Rüdiger, Manon J. N. L. Benders, Frank van Bel, Karel Allegaert, Gunnar Naulaers, Dirk Bassler, Katrin Klebermaß-Schrehof, Maximo Vento, Ana Vilan, Mari Falck, Isabella Mauro, Marjo Metsäranta, Sampsa Vanhatalo, Jan Mazela, Tuuli Metsvaht, Roselinda van der Vlught, Axel R. Franz, Christian F. Poets, Hercilia Guimarães, Tom Stiri, Luigi Cattarossi, Cees K. W. van Veldhuizen, Christian A. Maiwald, Iris Bergmann, Monika Weiss, Andreas Eichhorn, Michael Raubuch, Birgit Schuler, Bas Laméris, Thirza van Ramshorst, Tirol Kliniken, Johannes Brandner, Marie Tackoen, Ruth Reibel, Mari-Liis Ilmoja, Pille Saik, Ruth Käär, Pille Andresson, Klinikum der J. W. Goethe, Main Rolf Schloesser, Carl Gustav Carus, Stefan Winkler, Thomas Hoehn, Norbert Teig, Michael Schroth, Christoph Fusch, Ulrich H. Thome, Harald Ehrhardt, Ancona Virgilio Carnielli, Marcello Napolitano, Francesca Faldini, Bambini “V.Buzzi”, Milano Gianluca Lista, Mario Barbarini, Laura Pagani, Emmanuele Mastretta, Giovanni Vento, Monica Fumagalli, Mirjam M. van Weissenbruch, Henrica L. M. van Straaten, Kim V. Annink, Jeroen Dudink, Jan B. Derks, Inge P. de Boer, Clemens B. Meijssen, Timo R. de Haan, Linda G. van Rooij, Jacqueline L. van Hillegersberg, Minouche van Dongen, Koen P. Dijkman, Marlies A. van Houten, Sophie R. D. van der Schoor, Moritz Schneider, Eirik Nestaas, Britt Nakstad, Lukas Karpinski, Ewa Gulczynska, Claudia Ferraz, Almerinda Pereira, Rosalina Barroso, Mendes da Graça, Teresa Tomé, Filomena Pinto, Juan Martínez Rodilla, Maria Luz.Couce Pico, José Antonio Hurtado Suazo, Eva Valverde, José Ramón Fernández Lorenzo, Héctor Boix, Francisco Jimenez Parrilla, Dorotea Blanco, Begoña Loureiro, Maria Teresa Moral-Pumarega, Julia Maletzki, Claudia Knoepfli, Cornelia Hagmann, Michael Kleber, Martin Stocker, Thomas Riedel

Effect of immersive virtual reality-based cognitive remediation in patients with mood or psychosis spectrum disorders: study protocol for a randomized, controlled, double-blinded trial

Andreas E. Jespersen, Anders Lumbye, Maj Vinberg, Louise Glenthøj, Merete Nordentoft, Eva E. Wæhrens, Gitte M. Knudsen, Guido Makransky, Kamilla W. Miskowiak

  • Open Access
  • Methodology

Improving the inclusion of an under-served group in trials: development and implementation of the INCLUDE Impaired Capacity to Consent Framework

Victoria Shepherd, Katherine Joyce, Amanda Lewis, Samantha Flynn, Madeleine Clout, Brittany Nocivelli, Jeremy Segrott, Shaun Treweek

Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials)

Celia Jimenez-Garcia, Luis Angel Perula-de Torres, Enrique Villegas-Becerril, Juan Jose Muñoz-Gavilan, Maria Espinosa-Calvo, Gertrudis Montes-Redondo, Esperanza Romero-Rodriguez, Maria Carmen Moreno Manzanaro, Fatima Ginés Santiago, Carmen Bueno Serrano, Fabiola Romero Ruperto, Maria Cruz Linares Ramirez, Maria Angeles Quesada Román, Nieves Muñoz Alcaraz, Juan Manuel Parras Rejano, Maria Isabel Lopez Estepa, Maria Dolores Maestre-Serrano, Jaime Monserrat Villatoro

Standard vs. targeted oxygen therapy prehospitally for chronic obstructive pulmonary disease (STOP-COPD): study protocol for a randomised controlled trial

Arne Sylvester Rønde Jensen, Jan Brink Valentin, Mathilde Gundgaard Mulvad, Victor Hagenau, Søren Helbo Skaarup, Søren Paaske Johnsen, Ulla Væggemose, Martin Faurholdt Gude

PLUS-IS-LESS project: Procalcitonin and Lung UltraSonography-based antibiotherapy in patients with Lower rESpiratory tract infection in Swiss Emergency Departments: study protocol for a pragmatic stepped-wedge cluster-randomized trial

Cécile Bessat, Roland Bingisser, Markus Schwendinger, Tim Bulaty, Yvan Fournier, Vincent Della Santa, Magali Pfeil, Dominique Schwab, Jörg D. Leuppi, Nicolas Geigy, Stephan Steuer, Friedemann Roos, Michael Christ, Adriana Sirova, Tanguy Espejo, Henk Riedel, Alexandra Atzl, Fabian Napieralski, Joachim Marti, Giulio Cisco, Rose-Anna Foley, Melinée Schindler, Mary-Anne Hartley, Aurélie Fayet, Elena Garcia, Isabella Locatelli, Werner C. Albrich, Olivier Hugli, Noémie Boillat-Blanco, Noémie Boillat-Blanco, Werner C. Albrich, Nicolas Garin, Björn Mattsson, Stephan Gasser, Dieter Von Ow

  • Open Access
  • Malaria
  • Study protocol

DON in pediatric cerebral malaria, a phase I/IIA dose-escalation safety study: study protocol for a clinical trial 

Nginache Nampota-Nkomba, Osward M. Nyirenda, Jane Mallewa, Yamikani Chimalizeni, Nettie Dzabala, Michael P. Fay, Mathangi Gopalakrishnan, Matthew B. Laurens, Nicole F. O’Brien, Louis H. Miller, Susan K. Pierce, Brittany A. Riggle, Douglas G. Postels

  • Open Access
  • Study protocol

Preventing Respiratory Viral Illness Invisibly (PRiVII): protocol for a pragmatic cluster randomized trial evaluating far-UVC light devices in long-term care facilities to reduce infections

Hayden P. Nix, Samantha Meeker, Caroline E. King, Melissa Andrew, Ian R. C. Davis, Prosper S. Koto, Meaghan Sim, Jennifer Murdoch, Glenn Patriquin, Chris Theriault, Stephanie Reidy, Michael Rockwood, Tara Sampalli, Samuel D. Searle, Kenneth Rockwood

Transpalpebral electrical stimulation for the treatment of retinitis pigmentosa: study protocol for a series of N-of-1 single-blind, randomized controlled trial

Wei Zhou, Ziyang Huang, Kai Xu, Yamin Li, Xiaoyu Li, Jiaxian Li, Yu Jin, Torkel Snellingen, Lina Liang

Associate Principal Investigators and the HEAL-COVID trial: good for trainees, good for trials

Joseph Newman, Philip Wild, Charlotte Summers, Mark Toshner

Evaluating the effect of a behavioural intervention bundle on antibiotic use, quality of care, and household transmission of resistant Enterobacteriaceae in intervention versus control clusters in rural Burkina Faso and DR Congo (CABU-EICO)

Marianne van der Sande, Brecht Ingelbeen, Marie Meudec, Esther van Kleef, Linda Campbell, Edwin Wouters, Joachim Marien, Rianne van Vredendaal, Herwig Leirs, Daniel Valia, Sibidou Yougbare, Stephane Kouanda Juste, Aminata Welgo, Halidou Tinto, Delphin Mpanzu, Bijou Mbangi, Cesar-Augustin Khoso Muaka, Oscar Kiabanza, Adna Melanda, Richelin Makuaya, Didier Ndomba, Papa Mamadou Diagne, Leonard Heyerdahl, Tamara Giles-Vernick, Sandra Van Puyvelde, Ben Cooper

Effect of remimazolam vs propofol in high-risk patients undergoing upper gastrointestinal endoscopy: a non-inferiority randomized controlled trial

Zhi Li, Daming Yuan, Yu Yu, Jie Xu, Weili Yang, Li Chen, Nanbo Luo

  • Open Access
  • Study protocol

Impact of Menstrual cycle-based Periodized training on Aerobic performance, a Clinical Trial study protocol—the IMPACT study

Linda Ekenros, Philip von Rosen, Jessica Norrbom, Hans-Christer Holmberg, Carl Johan Sundberg, Cecilia Fridén, Angelica Lindén Hirschberg

  • Open Access
  • Methodology

Using healthcare systems data for outcomes in clinical trials: issues to consider at the design stage

Alice-Maria Toader, Marion K. Campbell, Jennifer K. Quint, Michael Robling, Matthew R Sydes, Joanna Thorn, Alexandra Wright-Hughes, Ly-Mee Yu, Tom. E. F. Abbott, Simon Bond, Fergus J. Caskey, Madeleine Clout, Michelle Collinson, Bethan Copsey, Gwyneth Davies, Timothy Driscoll, Carrol Gamble, Xavier L. Griffin, Thomas Hamborg, Jessica Harris, David A. Harrison, Deena Harji, Emily J. Henderson, Pip Logan, Sharon B. Love, Laura A. Magee, Alastair O’Brien, Maria Pufulete, Padmanabhan Ramnarayan, Athanasios Saratzis, Jo Smith, Ivonne Solis-Trapala, Clive Stubbs, Amanda Farrin, Paula Williamson

  • Open Access
  • Research

The use of healthcare systems data for RCTs

Alice-Maria Toader, Carrol L. Gamble, Susanna Dodd, Paula R. Williamson

Guidelines for reporting pediatric and child health clinical trial protocols and reports: study protocol for SPIRIT-Children and CONSORT-Children

Ami Baba, Maureen Smith, Beth K. Potter, An-Wen Chan, David Moher, Martin Offringa

Effectiveness and brain mechanism of multi-target transcranial alternating current stimulation (tACS) on motor learning in stroke patients: study protocol for a randomized controlled trial

Ming-Hui Lai, Xiao-Ming Yu, Yan Lu, Hong-Lin Wang, Wang Fu, Huan-Xia Zhou, Yuan-Li Li, Jun Hu, Jiayi Xia, Zekai Hu, Chun-Lei Shan, Feng Wang, Cong Wang

Digital health interventions for all? Examining inclusivity across all stages of the digital health intervention research process

Rebecca A. Krukowski, Kathryn M. Ross, Max J. Western, Rosie Cooper, Heide Busse, Cynthia Forbes, Emmanuel Kuntsche, Anila Allmeta, Anabelle Macedo Silva, Yetunde O. John-Akinola, Laura M. König

  • Open Access
  • Study protocol

The ROCK trial—a multidisciplinary Rehabilitation intervention for sudden Out-of-hospital Cardiac arrest survivors focusing on return-to-worK: a pragmatic randomized controlled trial protocol

Jan Christensen, Bo Gregers Winkel, Lilli Kirkeskov, Fredrik Folke, Matilde Winther-Jensen, Christine Eckhardt-Bentsen, Jesper Kjærgaard, Christian Hassager, Mette Kirstine Wagner

Effect of emerging digital technologies and methodologies combined with incentives on HbA1c in patients with type 2 diabetes mellitus: study protocol for a parallel, open randomized controlled trial

Shao Zhong, Jingyi Jiang, Hongying Liu, Ying Pan

mini-MED: study protocol for a randomized, multi-intervention, semi-controlled feeding trial of a Mediterranean-amplified vs. habitual Western dietary pattern for the evaluation of food-specific compounds and cardiometabolic health

Emily B. Hill, Minghua Tang, Julie M. Long, Jennifer F. Kemp, Jamie L. Westcott, Audrey E. Hendricks, Nichole A. Reisdorph, Wayne W. Campbell, Nancy F. Krebs, Claudia Schaefer, Gabrielle Glime, Katrina A. Doenges, Richard M. Reisdorph, Sakaiza Rasolofomanana Rajery, Kathryn Garvey, Robin Shandas, Sarah J. Borengasser, Daniel N. Frank

  • Open Access
  • Study protocol

Health economic evaluation of a nurse-assisted online eye screening in home healthcare to reduce avoidable vision impairment (iScreen): study protocol for a cluster randomized controlled trial

Vera Rooth, Hilde van der Aa, Robert P. L. Wisse, Otto R. Maarsingh, Marc Koopmanschap, Jan E. E. Keunen, Hester Vermeulen, Caroline C. W. Klaver, Gabriëlle Janssen, Ger H. M. B. van Rens, Ruth M. A. van Nispen

Cancer Precision-Prevention trial of Metformin in adults with Li Fraumeni syndrome (MILI) undergoing yearly MRI surveillance: a randomised controlled trial protocol

Miriam Dixon-Zegeye, Rachel Shaw, Linda Collins, Kendra Perez-Smith, Alexander Ooms, Maggie Qiao, Pan Pantziarka, Louise Izatt, Marc Tischkowitz, Rachel E. Harrison, Angela George, Emma R. Woodward, Simon Lord, Lara Hawkes, D. Gareth Evans, James Franklin, Helen Hanson, Sarah P. Blagden

A multicenter double-blind randomized crossover study comparing the impact of dorsal subthalamic nucleus deep brain stimulation versus standard care on apathy in Parkinson’s disease: a study protocol

T. J. C. Zoon, G. van Rooijen, M. F. Contarino, S. van der Gaag, R. Zutt, J. T. van Asseldonk, P. van den Munckhof, P. R. Schuurman, D. A. J. P. Denys, R. M. A. de Bie

  • Open Access
  • Commentary

Anticipating and strategizing to address potential bottlenecks during clinical research projects in sub-Saharan Africa: a case for adapting approaches and tools used in the entrepreneurial and development sectors

Yauba Saidu, Sangwe Clovis Nchinjoh, Amani Adidja, Andreas Frambo Besong, Palmer Masumbe Netongo, Paul Ndom, Marya Liebermann

  • Open Access
  • Study protocol

Pedicle screw placement accuracy in robot-assisted versus image-guided freehand surgery of thoraco-lumbar spine (ROBARTHRODESE): study protocol for a single-centre randomized controlled trial

Nicolas Aurouer, Patrick Guerin, Arnaud Cogniet, Nicolas Gangnet, Morad Pedram, Pierre-Thierry Piechaud, Jacobus H. Muller, Mo Saffarini, Sonia Ramos-Pascual, Kinga Michalewska, Paolo Mangione

  • Open Access
  • Methodology

How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials

Lauren Allen, Robert V. O’Toole, Michael J. Bosse, William T. Obremskey, Kristin R. Archer, Lisa K. Cannada, Jaimie Shores, Lisa M. Reider, Katherine P. Frey, Anthony R. Carlini, Elena D. Staguhn, Renan C. Castillo

  • Open Access
  • Research

Personalised versus standard text message prompts for increasing trial participant response to telephone follow-up: an embedded randomised controlled retention trial

Esther Herbert, Diana Papaioannou, Amanda Loban, Nikki Totton, Marie Hyslop, Robert Bolt, Christopher Deery

Correction: Study protocol for a randomised cross-over trial of Neurally adjusted ventilatory Assist for Neonates with Congenital diaphragmatic hernias: the NAN-C study

Grace Poole, Christopher Harris, Sandeep Shetty, Theodore Dassios, Allan Jenkinson, Anne Greenough

Impact of an integrated health, nutrition, and early child stimulation and responsive care intervention package delivered to preterm or term small for gestational age babies during infancy on growth and neurodevelopment: study protocol of an individually randomized controlled trial in India (Small Babies Trial)

Ranadip Chowdhury, Rukman Manapurath, Ingvild Fossgard Sandøy, Ravi Prakash Upadhyay, Neeta Dhabhai, Saijuddin Shaikh, Harish Chellani, Tarun Shankar Choudhary, Abhinav Jain, Jose Martines, Nita Bhandari, Tor A. Strand, Sunita Taneja

Correction: Improving pediatric COVID-19 vaccine uptake using an mHealth tool (MoVeUp): study protocol for a randomized, controlled trial

Russell J. McCulloh, Paul M. Darden, Jessica Snowden, Songthip Ounpraseuth, Jeannette Lee, Martina Clarke, Sophia R. Newcomer, Linda Fu, DeAnn Hubberd, Jaime Baldner, Maryam Garza, Ellen Kerns

Engaging Black youth in depression and suicide prevention treatment within urban schools: study protocol for a randomized controlled pilot

Michael A. Lindsey, Laura Mufson, Carolina Vélez-Grau, Tracy Grogan, Damali M. Wilson, Aaron O. Reliford, Meredith Gunlicks-Stoessel, James Jaccard

  • Open Access
  • Methodology

Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians

Deborah D. Stocken, Helen Mossop, Emma Armstrong, Steff Lewis, Susan J. Dutton, Claire Peckitt, Carrol Gamble, Julia Brown

Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania

Jillian L. Kadota, Laura J. Packel, Matilda Mlowe, Nzovu Ulenga, Natalino Mwenda, Prosper F. Njau, William H. Dow, Jingshen Wang, Amon Sabasaba, Sandra I. McCoy

Effectiveness of structured psycho-oncological counseling for relatives of lung cancer patients based on the CALM approach—study protocol of a randomized controlled trial

Julia Dusel, Karin Meng, Hanna Arnold, Antonia Rabe, Elisabeth Jentschke

  • Open Access
  • Suicide
  • Study protocol

Zero Self-Harm app: a mobile phone application to reduce non-suicidal self-injury—study protocol for a randomized controlled trial

Evelyn Guerrero, Kate Andreasson, Lene Larsen, Niels Buus, Jette Louise Skovgaard Larsen, Jesper Krogh, Rasmus Thastum, Lone Lindberg, Katrine Lindblad, Annette Erlangsen, Merete Nordentoft

  • Open Access
  • Review

Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review

Katrina M. Turner, Alyson Huntley, Tom Yardley, Sarah Dawson, Shoba Dawson

Effect of resuscitative endovascular balloon occlusion of the aorta in nontraumatic out-of-hospital cardiac arrest: a multinational, multicenter, randomized, controlled trial

Hee Eun Kim, Sheng-En Chu, You Hwan Jo, Wen-Chu Chiang, Dong-Hyun Jang, Chin-Hao Chang, So Hee Oh, Hsuan-An Chen, Seung Min Park, Jen-Tang Sun, Dong Keon Lee

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: study protocol for a pragmatic cluster-randomised controlled trial

Lauren Baerecke, Abigail Ornellas, Joyce Wamoyi, Mwita Wambura, Jonathan Klapwijk, Angelique N. Chetty, Ashlin Simpson, Roselinde Janowski, Kristen de Graaf, David Stern, Lily Clements, Esmee te Winkel, Laetitia Christine, Gervas Mbosoli, Kija Nyalali, Onduru Gervas Onduru, Anna Booij, Sussie N. Mjwara, Sibongile Tsoanyane, Gerry Mshana, Mbutolwe Esther Mwakitalu, G. J. Melendez-Torres, Francisco Calderon, Isang Awah, Ohad Green, Inge Vallance, Oluwaseyi Somefun, Frances Gardner, Lorraine Sherr, Mackenzie Martin, Jamie M. Lachman, Lucie D. Cluver

HYDROchlorothiazide versus placebo to PROTECT polycystic kidney disease patients and improve their quality of life: study protocol and rationale for the HYDRO-PROTECT randomized controlled trial

Thomas Bais, Esther Meijer, Bart J. Kramers, Priya Vart, Marc Vervloet, Mahdi Salih, Bert Bammens, Nathalie Demoulin, Polina Todorova, Roman-Ulrich Müller, Jan Halbritter, Alexander Paliege, Emilie Cornec-Le Gall, Bertrand Knebelmann, Roser Torra, Albert C. M. Ong, Fiona E. Karet Frankl, Ron T. Gansevoort

  • Open Access
  • Anxiety
  • Study protocol

Outpatient follow-up of tumour diseases through video-based value-oriented behavioural activation (ViVA): study protocol for a randomised controlled trial

Maren Reder, Christine Hofheinz, Lena Melzner, Gabriele Prinz, Christoph Kröger

Efficacy of amoxicillin/clavulanic acid after surgical drainage of perianal abscess in the prevention of the development of anal fistula (PERIQxA study): study protocol for a multicenter randomized, double-blind clinical trial

Verónica Polaino Moreno, Antonio F. Caballero-Bermejo, Mariano Artés Caselles, Javier Serrano González, Xabier Remírez Arriaga, Natalia González Alcolea, Aritz Equisoain Azcona, Eva Iglesias García, José Luis Lucena de la Poza, Arsenio Sánchez Movilla, Belén Ruiz-Antorán, Isabel Alonso Sebastián, Daniel Melero Montes, Carmen León Fernández, Jesús Álvarez Sánchez, Joaquín Muñoz Rodríguez, Juan González González, Miguel García-Oria Serrano, Ana Sánchez Ramos, Arturo García Pavía, Elena Jiménez Cubedo, Laura Román García de León, Maria Dolores Chaparro Cabezas, Javier López Monclús, Alberto Pueyo Rabanal, Matías Cea Soriano, Pedro Artuñedo Pe, Xiana Rial Justo, Miguel Suárez Sánchez, Lucía Gil Cidoncha, María del Pilar Martín Rodrigo, María Torguet Muñoz, Manuel Fernández Rodriguez, Cristián Grillo Marín, Celia Fidalgo Martínez, Javier Callau Pontaque, Pablo Galindo Jara, Laura Colao García, David Díaz Pérez, Ana Belén Gallardo Herrera, Enrique Esteban Agustí, Miguel A. Hernández Bartolomé, María Gutierrez Samaniego, César García Llorente, Lorenzo Rabadán Ruiz, Raquel Barriga Sánchez, Hector Ernesto Núñez Tasaico, Jaime Zabala Salinas, Natalia Almeida Romera, Raquel Ríos Blanco, Benito Miguel Josa Martínez, Eneida Bra Insa, Elena Sagarra Cebolla, Mónica García Aparicio, Paloma Garaulet González, Eduardo San Pío Carvajal, Miriam Fraile Vasallo, José Manuel Muros Bayo, Sergio Pedro Olivares Pizarro, Vicente Herrera Cabrera, Isaac Silvio Corrales Castillo, Elsa Pertejo Muñoz, Ricardo Ortega García, Ana Sánchez Gollarte, Rocío Maqueda González, Carlos Sáez Rodríguez, Mario Álvarez Gallego, Beatriz Díaz San Andrés, Ramón Cantero Cid, Carolina González Gómez, Inés Rubio Pérez, Fernando Tone Villanueva, Luis Asensio Gómez, Esteban Díaz Serrano, Blanca Monje Vera, Celia Castillo Marcos, Ana Belén Suárez Enriquez, Rebeca Abad Moret, Kriss Huerta Serracin

Continuous combined oral contraceptive use versus vitamin E in the treatment of menstrual migraine: rationale and protocol of a randomized controlled trial (WHAT!)

Britt W. H. van der Arend, Daphne S. van Casteren, Iris E. Verhagen, Antoinette MaassenVanDenBrink, Gisela M. Terwindt

Delivering integrated strategies from a mobile unit to address the intertwining epidemics of HIV and addiction in people who inject drugs: the HPTN 094 randomized controlled trial protocol (the INTEGRA Study)

David Goodman-Meza, Steven Shoptaw, Brett Hanscom, Laramie R. Smith, Philip Andrew, Irene Kuo, Jordan E. Lake, David Metzger, Ellen A. B. Morrison, Melissa Cummings, Jessica M. Fogel, Paul Richardson, Jayla Harris, Jesse Heitner, Sarah Stansfield, Nabila El-Bassel

Effectiveness of IT-supported patient recruitment: study protocol for an interrupted time series study at ten German university hospitals

Martin Boeker, Daniela Zöller, Romina Blasini, Philipp Macho, Sven Helfer, Max Behrens, Hans-Ulrich Prokosch, Christian Gulden

Impact of model-informed precision dosing in adults receiving vancomycin via continuous infusion: a randomized, controlled clinical trial

Glenn Van Wynsberge, Veerle Grootaert, Franky Buyle, Jens Van Praet, Roos Colman, Ine Moors, Annemie Somers, Diana Huis in ‘t Veld, Pieter De Cock, Kim Bigler, Andreas Capiau, Barbara Claus, Laure Degroote, Julie De Keulenaer, Sabine Deryckere, Lotte Deschepper, Sanne De Smet, Veronique De Smet, Astrid Heus, Liesbeth Huys, Jolien Langui, Tom Lodewyck, Sarah Mertens, Jeroen Neyt, Alexander Schauwvlieghe, Sylvia Snauwaert, Katleen Van Butsele, Stefaan Vandecasteele, Kevin Van Laethem, Karen Vermis, Barbara Verstraete

  • Open Access
  • Triage
  • Study protocol

Using a theory-based, customized video game as an educational tool to improve physicians’ trauma triage decisions: study protocol for a randomized cluster trial

Deepika Mohan, Derek C. Angus, Chung-Chou H. Chang, Jonathan Elmer, Baruch Fischhoff, Kim J. Rak, Jacqueline L. Barnes, Andrew B. Peitzman, Douglas B. White

  • Open Access
  • Methodology

The analysis of continuous data from n-of-1 trials using paired cycles: a simple tutorial

Stephen Senn

Obesity Treatments to Improve Type 1 Diabetes (OTID): a randomized controlled trial of the combination of glucagon-like peptide 1 analogues and sodium-glucose cotransporter 2 inhibitors—protocol for Obesity Treatments to Improve Type 1 Diabetes (the OTID trial)

Ebaa Al-Ozairi, Kavita Narula, Alexander D. Miras, Etab Taghadom, Abeer El Samad, Jumana Al Kandari, Anas Alyosef, Anant Mashankar, Werd Al-Najim, Carel W. le Roux

Application of the patient-reported outcome-based postoperative symptom management model in lung cancer: a multicenter randomized controlled trial protocol

Ying Liang, Pengyu Jing, Zhongping Gu, Lei Shang, Peng Ge, Yong Zhang, Lv Wang, Chun Qiu, Ximing Zhu, Zhijun Tan

  • Open Access
  • Research

Exploring critical intervention features and trial processes in the evaluation of sensory integration therapy for autistic children

Elizabeth Randell, Rachel McNamara, Monica Busse, Sue Delport, Rhys Williams-Thomas, Wakunyambo Maboshe, David Gillespie, Sarah Milosevic, Lucy Brookes-Howell, Melissa Wright, Richard P. Hastings, Anne Marie McKigney, Eleni Glarou, Alka Ahuja

Recurrences of advanced sessile and lateral spreading colorectal adenoma after endoscopic mucosal resection (EMR) thermal ablation versus no adjuvant therapy (RESPECT): a protocol of an international randomized controlled trial

Gijs Kemper, Christian Gerges, Erik J. Schoon, Ramon-Michel Schreuder, Ruud R. W. Schrauwen, Ludger S. M. Epping, Torsten Beyna, Joost P. H. Drenth, Ufuk Gündug, Peter D. Siersema, Erwin J. M. van Geenen

  • Open Access
  • Study protocol

The efficacy of virtual reality technology for the postoperative rehabilitation of patients with cervical spondylotic myelopathy (CSM): a study protocol for a randomized controlled trial

Jiajun Wu, Zhongchuan Sun, Zhichao Ge, Dong Zhang, Jianghan Xu, Rilin Zhang, Xuecheng Liu, Qing Zhao, Hao Sun

Efficacy of functional magnetic resonance imaging-guided personalized repetitive transcranial magnetic stimulation (fMRI-rTMS) in depressive patients with emotional blunting: study protocol for a randomized controlled trial

Yuyu Zhang, Nailong Tang, Lei Lei, Runxin Lv, Yaochi Zhang, Nian Liu, Haixia Chen, Min Cai, Huaning Wang

To allow or avoid pain during shoulder rehabilitation exercises for patients with chronic rotator cuff tendinopathy-Study protocol for a randomized controlled trial (the PASE trial)

Birgitte Hougs Kjær, Ann M. Cools, Finn E. Johannsen, Jeanette Trøstrup, Theresa Bieler, Volkert Siersma, Peter S. Magnusson

  • Open Access
  • Study protocol

Investigating the added effects of guidance in digital psychological self-care for alcohol problems (ALVA)—protocol for a randomized factorial optimization trial

Christopher Sundström, Ekaterina Ivanova, Philip Lindner, Magnus Johansson, Martin Kraepelien

Total laparoscopic partial hepatectomy versus open partial hepatectomy for primary left-sided hepatolithiasis: study protocol for a randomized controlled trial

Shu-bo Pan, Chun-li Wu, Da-chen Zhou, Qi-ru Xiong, Xiao-ping Geng, Hui Hou

Statistical analysis plan for the phaco TIp position during clear corneal Phacoemulsification Surgery (TIPS) randomized controlled trial

Soujanya Kaup, Dimple Kondal, Siddharudha Shivalli, John Buchan

  • Open Access
  • Research

Understanding implementation of findings from trial method research: a mixed methods study applying implementation frameworks and behaviour change models

Taylor Coffey, Paula R. Williamson, Katie Gillies

Comparison of 2D 4K vs. 3D HD laparoscopic imaging systems in bariatric surgery: study protocol for a randomized controlled prospective trial

Tibor A. Zwimpfer, Nadja Stiegeler, Philip C. Müller, Andreas Schötzau, Bernhard Fellmann-Fischer, Viola Heinzelmann-Schwarz, Ralph Peterli, Marko Kraljević

Evaluation of intensive community care services for young people with psychiatric emergencies: study protocol for a multi-centre parallel-group, single-blinded randomized controlled trial with an internal pilot phase

Thilipan Thaventhiran, Ben Hoi-Ching Wong, Izabela Pilecka, Saba Masood, Opeyemi Atanda, Joe Clacey, Jovanka Tolmac, Leon Wehncke, Liana Romaniuk, Margaret Heslin, Emma Tassie, Petrina Chu, Rhys Bevan-Jones, Ruth Woolhouse, Tauseef Mahdi, Veronika Beatrice Dobler, Mandy Wait, Paula Reavey, Sabine Landau, Sarah Byford, Toby Zundel, Dennis Ougrin

  • Open Access
  • Seroma
  • Study protocol

Seroma control in axillary lymphadenectomy with Glubran 2® without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain)

Sandra López Gordo, Neus Ruiz-Edo, Maria Teresa Fernández-Planas, Sara Viscaya-Martín, Cristina Serra-Serra, Carmen Buqueras, Mireia Recaj, Raul Guerrero-López, Lidia Blay-Aulina, Oscar Aparicio-Rodriguez, Laura Cusiné, Xavier Mira, Montserrat Clos, Immaculada Alonso, Jairo Cortés Prados, Sofía Espinoza Villalobos, Elena Vallejo-Barnosell, A. S. Espinoza-Villalobos, Marta Jimenez, Aurora Carrasquer-Puyal, Priscila Giselle Holub, Maria José Cases Baldo, E. Garcia de Castro R, Inmaculada Herrador Garcia, Emanuela Esposito, E. Garcia de Castro Rubio, Marta Lourdes Gonzalez Duaigues

  • Open Access
  • Study protocol

Trial protocol for the Building Resilience through Socio-Emotional Training (ReSET) programme: a cluster randomised controlled trial of a new transdiagnostic preventative intervention for adolescents

Essi Viding, Alex Lloyd, Roslyn Law, Peter Martin, Laura Lucas, Tom Chin-Han Wu, Nikolaus Steinbeis, Nick Midgley, René Veenstra, Jaime Smith, Lili Ly, Geoffrey Bird, Jennifer Murphy, David Plans, Marcus Munafo, Ian Penton-Voak, Jessica Deighton, Kathleen Richards, Mya Richards, Pasco Fearon

The effect of a cognitive training therapy based on stimulation of brain oscillations in patients with mild cognitive impairment in a Chilean sample: study protocol for a phase IIb, 2 × 3 mixed factorial, double-blind randomised controlled trial

Alejandra Figueroa-Vargas, Begoña Góngora, María Francisca Alonso, Alonso Ortega, Patricio Soto-Fernández, Lucía Z-Rivera, Sebastián Ramírez, Francisca González, Paula Muñoz Venturelli, Pablo Billeke

PAIN2.0: study protocol for a multicentre randomised controlled trial to evaluate the efficacy of a 10-week outpatient interdisciplinary multimodal pain therapy to manage recurrent pain for patients with risk factors of developing chronic pain in Germany

Sandra Meyer-Moock, Daniel Szczotkowski, Leonie Schouten, Frank Petzke, Lena Milch, Beatrice Metz-Oster, Louise Zinndorf, Christian Geber, Greta Hoffmann, Anke Preißler, Ursula Marschall, Felix Rottke, Anja Waidner, André Möller, Thomas Isenberg, Gabriele Lindena, Anne Gärtner, Ulrike Kaiser, Thomas Kohlmann

Comparing the effects of pulsed and radiofrequency catheter ablation on quality of life, anxiety, and depression of patients with paroxysmal supraventricular tachycardia: a single-center, randomized, single-blind, standard-controlled trial

Ying Du, Shanshan Ma, Pan Yue, Ying Xu, Ya Wen, Mingzhu Ji, Lingxiao He, Dengbin Liao

  • Open Access
  • Study protocol

Does somatosensory discrimination therapy alter sensorimotor upper limb function differently compared to motor therapy in children and adolescents with unilateral cerebral palsy: study protocol for a randomized controlled trial

Lize Kleeren, Lisa Mailleux, Belinda McLean, Catherine Elliott, Griet Dequeker, Anja Van Campenhout, Jean-Jacques Orban de Xivry, Geert Verheyden, Els Ortibus, Katrijn Klingels, Hilde Feys

  • Open Access
  • Study protocol

Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda

Catharina F. van der Boor, Dalili Taban, Wietse A. Tol, Josephine Akellot, Melissa Neuman, Helen A. Weiss, Giulia Greco, Anna Vassall, Carl May, Abhijit Nadkarni, Eugene Kinyanda, Bayard Roberts, Daniela C. Fuhr

An e-mental health intervention to reduce depression symptoms in individuals with obesity: study protocol for the randomized, controlled, two-armed, confirmatory LightMood trial

Dilara Kocol, Sheila Geiger, Adam Schweda, Jil Beckord, Theresa Schadendorf, Christoph Jansen, Anita Robitzsch, Eva-Maria Skoda, Martin Teufel, Alexander Bäuerle

Experience with a hybrid recruitment approach of patient-facing web portal screening and subsequent phone and medical record review for a neurosurgical intervention trial for chronic ischemic stroke disability (PISCES III)

Brad J. Kolls, Keith W. Muir, Sean I. Savitz, Lawrence R. Wechsler, Julie G. Pilitsis, Scott Rahimi, Richard L. Beckman, Vincent Holmes, Peng R. Chen, David S. Albers, Daniel T. Laskowitz

  • Open Access
  • Malaria
  • Study protocol

Efficacy of chlorfenapyr-pyrethroid and piperonyl butoxide-pyrethroid long-lasting insecticidal nets (LLINs) compared to pyrethroid-only LLINs for malaria control in Côte d’Ivoire: a three group, cluster randomised trial

Colette Sih, Natacha Protopopoff, Alphonsine A. Koffi, Ludovic P. Ahoua Alou, Edouard Dangbenon, Louisa A. Messenger, Manisha A. Kulkarni, Marius G. Zoh, Soromane Camara, Serge B. Assi, Raphael N’Guessan, Jackie Cook

Effects of a chronotype-adapted diet on weight loss, cardiometabolic health, and gut microbiota: study protocol for a randomized controlled trial

Monica Dinu, Sofia Lotti, Giuditta Pagliai, Antonia Napoletano, Marta Tristan Asensi, Ilaria Giangrandi, Rossella Marcucci, Amedeo Amedei, Barbara Colombini, Francesco Sofi

Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a statistical analysis plan for the ProMPT-2 randomised controlled trial

Helena Smartt, Gianni D. Angelini, Ben Gibbison, Chris A. Rogers

  • Open Access
  • Malaria
  • Study protocol

A randomised controlled trial to compare the efficacy, safety, and tolerability of low dose, short course primaquine in adults with uncomplicated P. vivax malaria in two hospitals in India

Sundus Shafat Ahmad, Reena Verma, Robert J. Commons, Nitika, Sauman Singh-Phulgenda, Rutuja Chhajed, Praveen K. Bharti, Beauty Behera, Syed Mohammad Naser, Salil Kumar Pal, Parinita Halder Ranjit, Rajendra Kumar Baharia, Bhavin Solanki, K. J. Upadhyay, Philippe J. Guerin, Amit Sharma, Ric N. Price, Manju Rahi, Kamala Thriemer

  • Open Access
  • Opioids
  • Study protocol

Integrated exercise program in opioid agonist therapy clinics and effect on psychological distress: study protocol for a randomized controlled trial (BAReAktiv)

Einar Furulund, Tesfaye Madebo, Karl Trygve Druckrey-Fiskaaen, Jørn Henrik Vold, Mette Hegland Nordbotn, Eivin Dahl, Sindre M. Dyrstad, Torgeir Gilje Lid, Lars T. Fadnes, Vibeke Bråthen Buljovcic, Jan Tore Daltveit, Trude Fondenes, Per Gundersen, Beate Haga Trettenes, Siv-Elin Leirvåg Carlsen, Maria Olsvold, Marianne Cook Pierron, Christine Sundal, Maren Borsheim Bergsaker, Tone Lise Eielsen, Torhild Fiskå, Marianne Larssen, Eirik Holder, Ewa Joanna Wilk, Mari Thoresen Soot

Aspin: neurosurgical aspirin intervention prognostic study — perioperative continuation versus discontinuation of aspirin in lumbar spinal surgery, a randomized controlled, noninferiority trial

Ahmed Zian, Gijsbert M. Overdevest, Pieter J. Schutte, Frederikus A. Klok, Ewout W. Steyerberg, Wouter A. Moojen, Niels A. van der Gaag

Study protocol: a core outcome set for perioperative exercise clinical effectiveness trials for lung cancer patients

Wanjun Zhou, Yawen Zhang, Zhiwei Wang, Liang Zhang, Xinqiong Zhang

  • Open Access
  • Anxiety
  • Study protocol

Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial

Anne H. Berman, Naira Topooco, Petra Lindfors, Marcus Bendtsen, Philip Lindner, Olof Molander, Martin Kraepelien, Christopher Sundström, Nooshin Talebizadeh, Karin Engström, George Vlaescu, Gerhard Andersson, Claes Andersson

  • Open Access
  • Study protocol

Solutions Trial: Solution Focused Brief Therapy (SFBT) in 10–17-year-olds presenting at police custody: a randomised controlled trial

Gwenllian Moody, Elinor Coulman, Emma Crocker-White, Kylie Gray, Richard P. Hastings, Andrea Longman, Fiona Lugg-Widger, Rebecca Playle, Jeremy Segrott, Paul Thompson, Julia Badger, Peter E. Langdon, Samantha Flynn

  • Open Access
  • Research

Coenzyme Q10 supplementation in burn patients: a double-blind placebo-controlled randomized clinical trial

Zahra Kiani, Nadereh Khorsand, Fahimeh Beigi, Gholamreza Askari, Manoj Sharma, Mohammad Bagherniya

  • Open Access
  • Letter

Response to Letter from Wong on determining the target difference in sample size calculations for randomised controlled trials

Jonathan A. Cook, Richard A. Parker

A proof of concept phase II study with the PDE-4 inhibitor roflumilast in patients with mild cognitive impairment or mild Alzheimer’s disease dementia (ROMEMA): study protocol of a double-blind, randomized, placebo-controlled, between-subjects trial

Nina Possemis, Frans Verhey, Jos Prickaerts, Arjan Blokland, Inez Ramakers

  • Open Access
  • Research

Recording harms in randomised controlled trials of behaviour change interventions: a qualitative study of UK clinical trials units and NIHR trial investigators

Diana Papaioannou, Kirsty Sprange, Sienna Hamer-Kiwacz, Cara Mooney, Gwenllian Moody, Cindy Cooper

Physiological-based cord clamping in very preterm infants: the Aeration, Breathing, Clamping 3 (ABC3) trial—statistical analysis plan for a multicenter randomized controlled trial

Sten P. Willemsen, Ronny Knol, Emma Brouwer, Thomas van den Akker, Philip L. J. DeKoninck, Enrico Lopriore, Wes Onland, Willem P. de Boode, Anton H. van Kaam, Debbie H. Nuytemans, Irwin K. M. Reiss, G. Jeroen Hutten, Sandra A. Prins, Estelle E. M. Mulder, Christian V. Hulzebos, Sam J. van Sambeeck, Mayke E. van der Putten, Inge A. Zonnenberg, Arjan B. te Pas, Marijn J. Vermeulen

  • Open Access
  • Malaria
  • Study protocol

Evaluation of a financial incentive intervention on malaria prevalence among the residents in Lake Victoria basin, Kenya: study protocol for a cluster-randomized controlled trial

Tomoya Matsumoto, Masaru Nagashima, Wataru Kagaya, James Kongere, Jesse Gitaka, Akira Kaneko

Effect of Postoperative Prolonged sedation with Dexmedetomidine after successful reperfusion with Endovascular Thrombectomy on long-term prognosis in patients with acute ischemic stroke (PPDET): study protocol for a randomized controlled trial

Li-na Yang, Yi Sun, Yu-zhu Wang, Jing Wang, Yi-sha Qi, Shan-shan Mu, Yun-peng Liu, Zi-qing Zhang, Zi-mo Chen, Xiao-jie Wang, Wu-xiang Xie, Chang-wei Wei, Yang Wang, An-shi Wu

  • Open Access
  • Caries
  • Study protocol

Effect of bottled fluoridated water to prevent dental caries in primary teeth: study protocol for a phase 2 parallel-group 3.5-year randomized controlled clinical trial (waterBEST)

Anne E. Sanders, Kimon Divaris, Tewodros R. Godebo, Gary D. Slade

The effects of intermittent fasting diet on quality of life, clinical symptoms, inflammation, and oxidative stress in overweight and obese postmenopausal women with rheumatoid arthritis: study protocol of a randomized controlled trial

Mahsa Ranjbar, Sakineh Shab-Bidar, Abdolrahman Rostamian, Hamed Mohammadi, Kurosh Djafarian

  • Open Access
  • Study protocol

UV light-mediated corneal crosslinking as (lymph)angioregressive pretreatment to promote graft survival after subsequent high-risk corneal transplantation (CrossCornealVision): protocol for a multicenter, randomized controlled trial

Johanna Wiedemann, Deniz Hos, Endrik Limburg, Ulrike Zettelmeyer, Petra Schiller, Jeremy Franklin, Björn Bachmann, Daniel Böhringer, Tina Dietrich-Ntoukas, Thomas A. Fuchsluger, Gerd Geerling, Stefan J. Lang, Wolfgang Johann Mayer, Siegfried Priglinger, Thomas Reinhard, Berthold Seitz, Claus Cursiefen

  • Open Access
  • Anemia
  • Study protocol

The effect of UNIMMAP multiple micronutrient supplements versus iron-folic acid and placebo in anemia reduction among women of reproductive age in Kebribeyah Woreda, Somali Regional State, Ethiopia: a study protocol for a community-based individual RCT

Desalegn Kuche, Zeweter Abebe, Masresha Tessema, Meron Girma, Alemayehu Hussen, Kaleab Baye, Barbara J. Stoecker

Statistical analysis plan for the PRO B study: open-label, superiority randomised controlled trial of alarm-based patient-reported outcome monitoring in patients with metastatic breast cancer

Pimrapat Gebert, Maria Margarete Karsten, Anna Maria Hage, Adam David Dordevic, Ulrike Grittner

  • Open Access
  • Fatigue
  • Study protocol

IA-PACS-CFS: a double-blinded, randomized, sham-controlled, exploratory trial of immunoadsorption in patients with chronic fatigue syndrome (CFS) including patients with post-acute COVID-19 CFS (PACS-CFS)

Hannah Preßler, Marie-Luise Machule, Friederike Ufer, Isabel Bünger, Lucie Yuanting Li, Emilie Buchholz, Claudia Werner, Esther Beraha, Frank Wagner, Matthes Metz, Susen Burock, Lisa Bruckert, Christiana Franke, Nicola Wilck, Anne Krüger, Alexander Reshetnik, Kai-Uwe Eckardt, Matthias Endres, Harald Prüss

  • Open Access
  • Study protocol

Behavioral economic and wellness-based approaches for reducing alcohol use and consequences among diverse non-student emerging adults: study protocol for Project BLUE, a randomized controlled trial

James G. Murphy, Ashley A. Dennhardt, Jacob Tempchin, Hannah E. Colgonis, Meghan E. McDevitt-Murphy, Brian Borsari, Kristoffer S. Berlin

  • Open Access
  • Suicide
  • Study protocol

Suicide prevention for substance using youth experiencing homelessness: study protocol for a randomized controlled trial

Natasha Slesnick, Brittany Brakenhoff, Laura J. Chavez, Caleb L. Cuthbertson, Ruri Famelia, Xin Feng, Jodi Ford, Eugene Holowacz, Soren Jaderlund, Kelly Kelleher, Ellison Luthy, Allen M. Mallory, Alexis Pizzulo, Tatiana D. Slesnick, Tansel Yilmazer

  • Open Access
  • Study protocol

The effect of donation frequency on donor health in blood donors donating plasma by plasmapheresis: study protocol for a randomized controlled trial

Morten Haugen, Karin Magnussen, Tonje Eiane Aarsland, Lise Sofie Haug Nissen-Meyer, Tor A. Strand

EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain (“EFFECT-BACK”): study protocol for a randomized controlled trial

Rabea Vogt, Julia Haas, Lukas Baumann, Anja Sander, Christina Klose, Jenny Riecke, Winfried Rief, Ulrike Bingel, Dustin Maser, Michael Witthöft, Jens Keßler, Marco Richard Zugaj, Beate Ditzen, Julia Anna Glombiewski

  • Open Access
  • Study protocol

Personalized, interdisciplinary patient pathway for cross-sector care of multimorbid patients (eliPfad trial): study protocol for a randomized controlled trial

Christoph Heinrich Lindemann, Volker Burst, Linus Alexander Völker, Sebastian Brähler, Dusan Simic, Ingrid Becker, Martin Hellmich, Clarissa Kurscheid, Nadine Scholten, Ruben Krauspe, Kerstin Leibel, Stephanie Stock, Paul Thomas Brinkkoetter

Correction: Tuberculosis (TB) Aftermath: study protocol for a hybrid type I effectiveness-implementation non-inferiority randomized trial in India comparing two active case finding (ACF) strategies among individuals treated for TB and their household contacts

Samyra R. Cox, Abhay Kadam, Sachin Atre, Akshay N. Gupte, Hojoon Sohn, Nikhil Gupte, Trupti Sawant, Vishal Mhadeshwar, Ryan Thompson, Emily Kendall, Christopher Hofmann, Nishi Suryavanshi, Deanna Kerrigan, Srikanth Tripathy, Arjunlal Kakrani, Madhusudan S. Barthwal, Vidya Mave, Jonathan E. Golub

  • Open Access
  • Study protocol

Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial

Camilla Angelsen Kvestad, Ingvild Rønneberg Holte, Solveig Klæbo Reitan, Charlotte S. Chiappa, Gunn Karin Helle, Anne E. Skjervold, Anne Marit A. Rosenlund, Øyvind Watne, Heidi Brattland, Jon Helle, Turid Follestad, Karen Walseth Hara, Katrine Høyer Holgersen

Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial

Isabelle R. Weir, Suzanne M. Dufault, Patrick P. J. Phillips

The efficacy and safety of deucravacitinib compared to methotrexate, in patients with vulvar lichen planus who have failed topical therapy with potent corticosteroids: a study protocol for a single-centre double-blinded randomised controlled trial

Marlene Wijaya, Gayle Fischer, Rebecca Bronwyn Saunderson

The scientific rationale and study protocol for the DPP3, Angiotensin II, and Renin Kinetics in Sepsis (DARK-Sepsis) randomized controlled trial: serum biomarkers to predict response to angiotensin II versus standard-of-care vasopressor therapy in the treatment of septic shock

J. Pedro Teixeira, David Perez Ingles, Jordan B. Barton, James T. Dean, Pablo Garcia, Susan J. Kunkel, Preeyaporn Sarangarm, Natalie K. Weiss, Christopher L. Schaich, Laurence W. Busse, Nathan D. Nielsen

  • Open Access
  • Methodology

Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)

C. E. Arundel, L. K. Clark, A. Parker, D. Beard, E. Coleman, C. Cooper, D. Devane, S. Eldridge, S. Galvin, K. Gillies, C. E. Hewitt, C. Sutton, D. J. Torgerson, S. Treweek

The effectiveness of therapeutic craft-making activities in treating lower-third forearm fracture: study protocol for a randomized controlled trial

Rui Fen Teoh, Siaw Chui Chai, Nor Afifi Razaob Razab, Mohd Iskandar Mohd Amin, Julianne W. Howell

Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial

Jiabin Shen, Yan Wang, Susan Quinn, Stacy J. Suskauer, Julia Birch, Tyler Busch, Adrian Svingos, Roger Crawfis, Keith Owen Yeates, H. Gerry Taylor

Correction: Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial

Nick Birk, Laura L. Oakley, Poppy A. C. Mallinson, Deepa R, Giridhara R. Babu, Mofat Nyirenda, Sanjay Kinra

The clinical effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: results from a multicenter, pragmatic randomized controlled trial

Ericka C. Solis, Ingrid V. E. Carlier, Noëlle G. A. Kamminga, Erik J. Giltay, Albert M. van Hemert

Engaging Fathers for Effective Child Nutrition and Development in Tanzania (EFFECTS): study protocol for a five-arm, cluster-randomized trial

Isaac Lyaatu, Dominic Mosha, Mary Mwanyika Sando, Joshua Jeong, Aisha Yousafzai, George PrayGod, Roman Evarist, Lauren Galvin, Mary Pat Kieffer, Elfrida Kumalija, Jennifer Simpson, Ramya Ambikapathi, Morgan Boncyk, Evidence Matangi, Nilupa S. Gunaratna

  • Open Access
  • Research

Trials that turn from retrospectively registered to prospectively registered: a cohort study of “retroactively prospective” clinical trial registration using history data

Martin Holst, Benjamin Gregory Carlisle

Heart rate and breathing effects on attention and memory (HeartBEAM): study protocol for a randomized controlled trial in older adults

Kaoru Nashiro, Hyun Joo Yoo, Christine Cho, Andy Jeesu Kim, Padideh Nasseri, Jungwon Min, Martin J. Dahl, Noah Mercer, Jeiran Choupan, Paul Choi, Hye Rynn J. Lee, David Choi, Kalekirstos Alemu, Alexandra Ycaza Herrera, Nicole F. Ng, Julian F. Thayer, Mara Mather

Mean Arterial Pressure (MAP) Trial: study protocol for a multicentre, randomized, controlled trial to compare three different strategies of mean arterial pressure management during cardiopulmonary bypass

Alessandra Francica, Gina Mazzeo, Antonella Galeone, Daniele Linardi, Livio San Biagio, Giovanni Battista Luciani, Francesco Onorati

Correction: Detailed statistical analysis plan for ALBINO: effect of Allopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome — a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)

Corinna Engel, Mario Rüdiger, Manon J. N. L. Benders, Frank van Bel, Karel Allegaert, Gunnar Naulaers, Dirk Bassler, Katrin Klebermaß-Schrehof, Maximo Vento, Ana Vilan, Mari Falck, Isabella Mauro, Marjo Metsäranta, Sampsa Vanhatalo, Jan Mazela, Tuuli Metsvaht, Roselinda van der Vlught, Axel R. Franz

  • Open Access
  • Study protocol

Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs

Emma Bamford, Hannah Berntsson, Suzanne Beale, Lauren Desoysa, Joseph Dias, Sienna Hamer-Kiwacz, Daniel Hind, Nick Johnson, Amanda Loban, Kaye Molloy, Emma Morvan, Ines Rombach, Anna Selby, Praveen Thokala, Chris Turtle, Stephen Walters, Avril Drummond

  • Open Access
  • Study protocol

The IMPROVE trial: study protocol for a pragmatic cluster randomised controlled trial to assess the effectiveness of using lay health workers to improve uptake and completion of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease

Gill Gilworth, Katherine Harris, Toby L. Morgan, Salma Ayis, Julia Fox-Rushby, Emma Godfrey, Nicholas S. Hopkinson, Simon Lewin, Ka Keat Lim, Arietta Spinou, Stephanie J. C. Taylor, Patrick White

Effectiveness of telerehabilitation intervention to improve pain and physical function in people with patellofemoral pain syndrome: study protocol for a randomized controlled trial

Negar Amirabadi, Masumeh Hessam, Saeideh Monjezi, Farshad Molhemi, Mohammad Mehravar, Pardis Hosseinpour

  • Open Access
  • Obesity
  • Study protocol

Lifestyle intervention in children with obesity and nonalcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled trial in Ningbo city (the SCIENT study)

Ping-ping Zhang, You-xin Wang, Fang-jing Shen, Yun-fei Xing, Jia-ying Gu, Xue-ying Li, Han Jin, Shi-feng Jin, Miao Xu, Hai-jun Wang, Hui Wang, Li Li

Bronchiolitis recovery and the use of High Efficiency Particulate Air (HEPA) Filters (The BREATHE Study): study protocol for a multi-center, parallel, double-blind, randomized controlled clinical trial

Kelly Cowan, Erin O. Semmens, Jeannette Y. Lee, Ethan S. Walker, Paul G. Smith, Linda Fu, Rosalyn Singleton, Sara McClure Cox, Jennifer Faiella, Laurie Chassereau, Lora Lawrence, Jun Ying, Jaime Baldner, Maryam Garza, Robert Annett, Sheva K. Chervinskiy, Jessica Snowden

Multicentre, randomised controlled trial of physiological-based cord clamping versus immediate cord clamping in infants with a congenital diaphragmatic hernia (PinC): statistical analysis plan

Emily J. J. Horn-Oudshoorn, Marijn J. Vermeulen, Ronny Knol, Rebekka Bout-Rebel, Arjan B. te Pas, Stuart B. Hooper, Suzan C. M. Cochius-den Otter, Rene M. H. Wijnen, Kelly J. Crossley, Neysan Rafat, Thomas Schaible, Willem P. de Boode, Anne Debeer, Berndt Urlesberger, Calum T. Roberts, Florian Kipfmueller, Irma Capolupo, Carmen M. Burgos, Bettina E. Hansen, Irwin K. M. Reiss, Philip L. J. DeKoninck

  • Open Access
  • Research

Choosing and evaluating randomisation methods in clinical trials: a qualitative study

Cydney L. Bruce, Mais Iflaifel, Alan Montgomery, Reuben Ogollah, Kirsty Sprange, Christopher Partlett

Transcranial alternating current stimulation improves quality of life in Parkinson’s disease: study protocol for a randomized, double-blind, controlled trial

Hong-yu Zhang, Ting-ting Hou, Zhao-hui Jin, Tian Zhang, Yi-heng Wang, Zi-hao Cheng, Yong-hong Liu, Jin-ping Fang, Hong-jiao Yan, Yi Zhen, Xia An, Jia Du, Ke-ke Chen, Zhen-zhen Li, Qing Li, Qi-ping Wen, Bo-yan Fang

  • Open Access
  • Study protocol

The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory assist versus non-synchronized nasal intermittent positive pressure ventilation

David N. Matlock, Sarah J. Ratcliffe, Sherry E. Courtney, Haresh Kirpalani, Kimberly Firestone, Howard Stein, Kevin Dysart, Karen Warren, Mitchell R. Goldstein, Kelli C. Lund, Aruna Natarajan, Ejigayehu Demissie, Elizabeth E. Foglia

A cluster-randomized study to evaluate the effectiveness and cost-effectiveness of the Assessment of Burden of Chronic Conditions (ABCC) tool in South Tyrolean primary care for patients with COPD, asthma, type 2 diabetes, and heart failure: the ABCC South Tyrol study

Christian J. Wiedermann, Pasqualina Marino, Angelika Mahlknecht, Verena Barbieri, Giuliano Piccoliori, Adolf Engl, Annerika H. M. Gidding-Slok

Investigating the use of finerenone in children with chronic kidney disease and proteinuria: design of the FIONA and open-label extension studies

Franz Schaefer, Giovanni Montini, Hee Gyung Kang, Johan Vande Walle, Joshua Zaritsky, Michiel F. Schreuder, Mieczyslaw Litwin, Andrea Scalise, Helen Scott, James Potts, Pablo Iveli, Stefanie Breitenstein, Bradley A. Warady

  • Open Access
  • Methodology

Developing generic templates to shape the future for conducting integrated research platform trials

Madhavi Gidh-Jain, Tom Parke, Franz König, Cecile Spiertz, Peter Mesenbrink, Fabienne Baffert, Robert Patrizi

Interactive virtual assistance for mental health promotion and self-care management in elderly with type 2 diabetes (IVAM-ED): study protocol and statistical analysis plan for a randomized controlled trial

Frederico Ludwig da Costa, Lucas Strassburger Matzenbacher, Vicenzo Gheno, Maria Antônia Bertuzzo Brum, Laura Gomes Boabaid de Barros, Isabela Semmelmann Maia, Luiza Machado Blank, Lucas Friedrich Fontoura, Janine Alessi, Gabriela Heiden Telo

  • Open Access
  • Study protocol

Evaluation of a disability-inclusive ultra-poor graduation programme in Uganda: study protocol for a cluster-randomised controlled trial with process evaluation

Elijah Kipchumba, Calum Davey, Sarah Marks, Anthony Mugeere, Shanquan Chen, Lena Morgon Banks, Kazi Eliza Islam, Tom Shakespeare, Hannah Kuper, Munshi Sulaiman

Effect of an entry-to-care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: a study protocol for a cluster-randomized trial

Steffan Holst Hansen, Troels Mygind Jensen, Gitte Stentebjerg Petersen, Francois Pouwer, Anders Larrabee Sonderlund, Jens Søndergaard

  • Open Access
  • Correction

Correction: Effectiveness and cost-effectiveness of a transdiagnostic intervention for alcohol misuse and psychological distress in humanitarian settings: study protocol for a randomised controlled trial in Uganda

Catharina F. van der Boor, Dalili Taban, Wietse A. Tol, Josephine Akellot, Melissa Neuman, Helen A. Weiss, Giulia Greco, Anna Vassall, Carl May, Abhijit Nadkarni, Eugene Kinyanda, Bayard Roberts, Daniela C. Fuhr

The effect of selenium supplementation on oxidative stress, clinical symptoms and mental health status in patients with migraine: a study protocol for a double-blinded randomized clinical trial

Arghavan Balali, Omid Sadeghi, Javad Anjom-Shoae, Mohammad Hossein Rouhani, Fariborz Khorvash, Gholamreza Askari

Sacral neuromodulation for constipation and fecal incontinence in children and adolescents – study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique

Manuel Besendörfer, Annemarie Kirchgatter, Roman Carbon, Christel Weiss, Hanna Müller, Klaus E. Matzel, Sonja Diez

The effects of Phoniatric PREhabilitation in Head and Neck Cancer patients on Aspiration and Preservation of Swallowing (PREHAPS): study protocol of a monocentric prospective randomized interventional outcome-blinded trial

Julian Kuenzel, Stephan Duerr, Sarah Vester, Florian Zeman, Gunnar Huppertz, Michael Koller, Gerda Pfleger, Annika Woertgen, Hazem Salloum, Monika Klinkhammer-Schalke, Tobias Pukrop, Peter Kummer

Peers plus mobile app for treatment in HIV (PATH): protocol for a randomized controlled trial to test a community-based integrated peer support and mHealth intervention to improve viral suppression among Hispanic and Black people living with HIV

Eileen V. Pitpitan, Keith J. Horvath, Jeannette Aldous, Jamila K. Stockman, Thomas L. Patterson, Megan Liang, Constantino Barrozo, Veronica Moore, Katherine Penninga, Laramie R. Smith

Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study)

Lillian Streichart, Marie Felldin, Jana Ekberg, Lars Mjörnstedt, Per Lindnér, Annette Lennerling, Verena Bröcker, Johan Mölne, Jan Holgersson, Kristien Daenen, Lars Wennberg, Tomas Lorant, Seema Baid-Agrawal

The ARIA trial protocol: a randomised controlled trial to assess the clinical, technical, and cost-effectiveness of a cloud-based, ARtificially Intelligent image fusion system in comparison to standard treatment to guide endovascular Aortic aneurysm repair

James Budge, Tom Carrell, Medeah Yaqub, Hatem Wafa, Matt Waltham, Izabela Pilecka, Joanna Kelly, Caroline Murphy, Stephen Palmer, Yanzhong Wang, Rachel E Clough

  • Open Access
  • Commentary

Navigating uncharted territory with a borrowed map: lessons from setting up the BATH-OUT-2 randomised controlled trial in adult social care and housing services in English local authorities

Jennifer McAnuff, Tim Rapley, Leigh Rooney, Phillip Whitehead

Pneumococcal conjugate vaccination schedules in infants—acquisition, immunogenicity, and pneumococcal conjugate and yellow fever vaccine co-administration study: statistical analysis plan

Grant A. Mackenzie, Isaac Osei, Rasheed Salaudeen, Paul V. Licciardi, Brian Greenwood, Kim Mulholland, Cattram Nguyen

Implementing and evaluating group interpersonal therapy for postnatal depression in Lebanon and Kenya—individually randomised superiority trial

Peter Fonagy, Rabih El Chammay, Carol Ngunu, Manasi Kumar, Lena Verdeli, Elizabeth Allison, Ghida Anani, Pasco Fearon, Fouad Fouad, Zoe Hoare, Lucina Koyio, Henrietta Moore, Andrew Nyandigisi, Stephen Pilling, Hannah Sender, Jolene Skordis, Rachel Evans, Gerard Joseph Abou Jaoude, Beatrice Madeghe, Sandra Pardi Arsen Maradian, Ciara O’Donnell, Elizabeth Simes, Alexandra Truscott, Grace Nduku Wambua, Obadia Yator

Clinical statistical analysis plan for the ACCURE trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicentre trial

Eva Visser, Lianne Heuthorst, Shri Pathmakanthan, Willem A. Bemelman, Geert R. D’Haens, Kelly Handley, Apostolos Fakis, Thomas D. Pinkney, Christianne J. Buskens, Marcel G. W. Dijkgraaf

Optimization of cardiopulmonary bypass prime fluid to preserve microcirculatory perfusion during on-pump coronary artery bypass graft surgery: PRIME study protocol for a double-blind randomized trial

Anne M. Beukers, Carolien S. E. Bulte, Ruben J. Bosch, Susanne Eberl, Charissa E. van den Brom, Stephan A. Loer, Alexander B. A. Vonk

Cost-effectiveness and cost-utility of the ball-and-socket trapeziometacarpal prosthesis compared to trapeziectomy and ligament reconstruction: study protocol for a randomized controlled clinical trial

Serafín Lirola-Palmero, Guillem Salva-Coll, Aina María Yáñez-Juan, Eduardo Sánchez-Iriso

The REPAIR study: oral antibiotics to prevent infection and wound dehiscence after obstetric perineal tear—a double-blinded placebo controlled randomized trial

Kathrine Perslev, Niels Klarskov, Thomas Bergholt, Hanna Jangö

Individual Placement and Support for persons with alcohol and drug addiction in a Swedish context (IPS-ADAS): study protocol for a randomised controlled trial

Ulrika Bejerholm, Anders Håkansson, Marcus Knutagård, Helene Hillborg

Study protocol for a prospective, randomized, multicenter trial to investigate the influence of peripheral nerve stimulation on patients with chronic sacroiliac joint syndrome (SILENCING)

Tarik Alp Sargut, Dimitri Tkatschenko, Anton Früh, Jochen Tüttenberg, Alexander Heckert, Steffen Fleck, Anja Kuckuck, Simon Heinrich Bayerl

  • Open Access
  • Research

Current usage of explainer animations in trials: a survey of the UKCRC registered clinical trial units in the UK

Vicki S. Barber, Clare Calvert, Duncan Appelbe, Kirsty Sprange, Claire Nollett, Samantha Tanner, Duncan B. Richards

  • Open Access
  • Study protocol

Design and evaluation of mobile application for adolescents’ self-care: protocol for a randomized controlled field trial

Razieh Rezaee, Mohtasham Ghaffari, Reza Rabiei, Amir Kavousi, Sakineh Rakhshanderou

A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial

Shayan Farzanbakhsh, Mohammad Amin Shahrbaf, Hoda Madani, Mostafa Dahmardei, Bahareh Sadri, Massoud Vosough

A pragmatic randomized controlled trial to evaluate the efficacy and safety of an oral short-course regimen including bedaquiline for the treatment of patients with multidrug-resistant tuberculosis in China: study protocol for PROSPECT

Jingtao Gao, Mengqiu Gao, Jian Du, Yu Pang, Gary Mao, Nacer Lounis, Nyasha Bakare, Yanxin Jiang, Ying Zhan, Yuhong Liu, Liang Li, Liu Rongmei, Du Juan, Wu Guihui, Pei Yi, Sha Wei, Shi Lian, Wang Hua, Jin Long, Wu Yuqing, Xiong Yu, Yan Xiaofeng, Chen Xiaohong, Huang Zhongfeng, Ren Fei, Li Xiujie, An Huiru, Cui Junwei

Study protocol for a pragmatic randomised controlled trial of comparing enhanced acceptance and commitment therapy plus (+) added to usual aftercare versus usual aftercare only, in patients living with or beyond cancer: SUrvivors’ Rehabilitation Evaluation after CANcer (SURECAN) trial

Imran Khan, Stephanie J. C. Taylor, Clare Robinson, Elisavet Moschopoulou, Paul McCrone, Liam Bourke, Mohamed Thaha, Kamaldeep Bhui, Derek Rosario, Damien Ridge, Sheila Donovan, Ania Korszun, Paul Little, Adrienne Morgan, Olivier Quentin, Rebecca Roylance, Peter White, Trudie Chalder

Prednisolone Versus Colchicine for Acute Gout in Primary Care: statistical analysis plan for the pragmatic, multicenter, randomized, and double-blinded COPAGO non-inferiority trial

Adrian Richter, Julia Truthmann, Eva Hummers, Julia Freyer Martins Pereira, Ildikó Gágyor, Franziska Schuster, Amelie Witte, Susanne Böhm, Alexandra Greser, Petra Kamin, Sylvia Stracke, Marcus Dörr, Robin Bülow, Stefan Engeli, Jean François Chenot, Till Ittermann

5-EPIFAT trial protocol: a multi-center, randomized, placebo-controlled trial of the efficacy of pharmacotherapy for fatigue using methylphenidate, bupropion, ginseng, and amantadine in advanced cancer patients on active treatment

Mojtaba Miladinia, Mina Jahangiri, Sharon Jackson White, Hossein Karimpourian, Alessandro Inno, Sally Wai-Chi Chan, Reza Ganji, Mahmood Maniati, Kourosh Zarea, Marziyeh Ghalamkari, Ali Farahat, Cecilia Fagerström

  • Open Access
  • Anxiety
  • Study protocol

Effectiveness of WeChat-assisted preoperative education to reduce perioperative anxiety in breast cancer patients: a prospective randomized controlled study protocol

Xiao Xiao, Yi-Ding Zuo, Shu-Yu Kuang, Chun-Yuan Liu, Kun-Shao, Heng Wang, Si-Yu Yan, Feng Yu, Yan Xu, Li Zhou, Chun-Ling Jiang

Efficacy of supervised immersive virtual reality-based training for the treatment of chronic fatigue in post-COVID syndrome: study protocol for a double-blind randomized controlled trial (IFATICO Trial)

Jonas Tesarz, Hannah Lange, Marietta Kirchner, Axel Görlach, Wolfgang Eich, Hans-Christoph Friederich

  • Open Access
  • Correction

Correction: Effect of an entry-to-care intervention on diabetes distress in individuals with newly diagnosed type 2 diabetes: a study protocol for a cluster-randomized trial

Steffan Holst Hansen, Troels Mygind Jensen, Gitte Stentebjerg Petersen, Francois Pouwer, Anders Larrabee Sonderlund, Jens Søndergaard

  • Open Access
  • Study protocol

Increasing access to mental health supports for 12–17-year-old Indigenous youth with the JoyPop mobile mental health app: study protocol for a randomized controlled trial

Aislin R. Mushquash, Teagan Neufeld, Ishaq Malik, Elaine Toombs, Janine V. Olthuis, Fred Schmidt, Crystal Dunning, Kristine Stasiuk, Tina Bobinski, Arto Ohinmaa, Amanda Newton, Sherry H. Stewart

ROBot-assisted physical training of older patients during acUte hospitaliSaTion—study protocol for a randomised controlled trial (ROBUST)

Ann Sophia Bertelsen, Tahir Masud, Charlotte Suetta, Lisbeth Rosenbek Minet, Stig Andersen, Jørgen T. Lauridsen, Jesper Ryg

  • Open Access
  • Research

Alternative consent methods used in the multinational, pragmatic, randomised clinical trial SafeBoosC-III

Maria Linander Vestager, Mathias Lühr Hansen, Gorm Greisen, Adelina Pellicer, Caitriona Ni Chathasaigh, Chantal Lecart, Claudia Knoepfli, Cornelia Hagmann, Dario Gallo, Ebru Ergenekon, Eleftheria Hatzidaki, Eugene Dempsey, Evangelina Papathoma, Gabriel Dimitrou, Gerhard Pichler, Gitte Holst Hahn, Gunnar Naulaers, Hans Fuchs, Hilal Ozkan, Isabel de las Cuevas, Itziar Serrano-Viñuales, Jan Sirc, Julie de Buyst, Kosmos Sarafidis, Luis Arrusa, Mariana Baserga, Martin Stocker, Merih Cetinkaya, Miguel Alsina, Monica Fumagalli, Olalla Otero Vaccarello, Olivier Baud, Pamela Zafra-Rodríguez, Pierre Maton, Quoqiang Cheng, Ruth del Rio Florentino, Ryszard Lauterbach, Salvador Piris-Borregas, Saudamini Nesargi, Siv Fredly, Sylwia Marciniak, Tomasz Szczapa, Xiaoyang Gao, Xin Xu

  • Open Access
  • Study protocol

Does the use of higher versus lower oxygen concentration improve neurodevelopmental outcomes at 18–24 months in very low birthweight infants?

Georg M. Schmölzer, Elizabeth V. Asztalos, Marc Beltempo, Hector Boix, Eugene Dempsey, Walid El-Naggar, Neil N. Finer, Jo-Anna Hudson, Amit Mukerji, Brenda H. Y. Law, Maryna Yaskina, Prakesh S. Shah, Ayman Sheta, Amuchou Soraisham, William Tarnow-Mordi, Max Vento

Effect of prebiotic oligosaccharides on bowel habit and the gut microbiota in children with functional constipation (Inside study): study protocol for a randomised, placebo-controlled, multi-centre trial

Carrie A. M. Wegh, Margriet H. C. Schoterman, Elaine E. Vaughan, Sofie C. C. van der Zalm, Hauke Smidt, Clara Belzer, Marc A. Benninga

The effects of telerehabilitation in adults with complex biventricular congenital heart conditions: protocol for a multi-centre, randomised controlled trial—CH-FIT

Gina Wood, Anna Scheer, Jelena Saundankar, Derek Tran, Rachael Cordina, Andrew Maiorana

  • Open Access
  • Research

The clinical trial activation process: a case study of an Italian public hospital

Carolina Pelazza, Marta Betti, Francesca Marengo, Annalisa Roveta, Antonio Maconi

  • Open Access
  • Review

Statistical analyses of ordinal outcomes in randomised controlled trials: a scoping review

Chris J. Selman, Katherine J. Lee, Kristin N. Ferguson, Clare L. Whitehead, Brett J. Manley, Robert K. Mahar

Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial

Richard E. Liebano, Kathleen A. Sluka, Joshua Roy, Meghan Savinelli, Dana L. Dailey, Sean P. Riley

A placebo-controlled, crossover trial to investigate the efficacy of tiotropium bromide or placebo added to usual care in stable symptomatic post-hematopoietic stem cell transplantation (HSCT) bronchiolitis obliterans syndrome (BOS)

Naeemeh Dini, Amin Pastaki Khoshbin, Rasoul Aliannejad, Hooman Bakhshandeh, Katayoun Najafizadeh, Mahshid Mehdizadeh, Shahideh Amini

Clinical effects of atorvastatin combined with conbercept in the treatment of patients with macular edema secondary to retinal vein occlusion and carotid plaque: study protocol for a prospective randomized controlled trial

Bangtao Yao, Bei Wang, Jun Yang, Yan Geng, Hao Yu, Yuhui Liu, Gang Liu, Xiuying Wang

Nutrition and movement to improve quality of life in patients with knee osteoarthritis: the NUMOQUA study protocol for a randomised controlled trial

Elisabeth Höld, Sabine Chmelar, Tatjana Aubram, Gabriele Leitner, Stefan Nehrer, Oliver Neubauer, Karl-Heinz Wagner, Barbara Wondrasch

Effects of cognitive behavioural therapy and bright light therapy for insomnia in youths with eveningness: study protocol for a randomised controlled trial

Shirley Xin Li, Forrest Tin Wai Cheung, Ngan Yin Chan, Joey Wing Yan Chan, Jihui Zhang, Albert Martin Li, Colin A. Espie, Michael Gradisar, Yun-Kwok Wing

Validation of the predictive value of BDNF -87 methylation for antidepressant treatment success in severely depressed patients—a randomized rater-blinded trial

Hannah Benedictine Maier, Alexandra Neyazi, Gabriel L. Bundies, Fiona Meyer-Bockenkamp, Stefan Bleich, Hansi Pathak, Yvonne Ziert, Barbara Neuhaus, Franz-Josef Müller, Iris Pollmann, Thomas Illig, Stefanie Mücke, Meike Müller, Brinja Kira Möller, Steffen Oeltze-Jafra, Tim Kacprowski, Jan Voges, Fabian Müntefering, Josef Scheiber, Andreas Reif, Mareike Aichholzer, Christine Reif-Leonhard, Maren Schmidt-Kassow, Ulrich Hegerl, Hanna Reich, Stefan Unterecker, Heike Weber, Jürgen Deckert, Nicole Bössel-Debbert, Hans J. Grabe, Michael Lucht, Helge Frieling

  • Open Access
  • Study protocol

RISEinFAMILY project: the integration of families at neonatal intensive care units (NICUs) to empower them as primary caregivers: study protocol for a stepped wedge cluster controlled trial

M. T. Alferink, B. Moreno-Sanz, M. Cabrera-Lafuente, E. Ergenekon, T. R. de Haan, A. A. M. W. van Kempen, J. Lakhwani, H. Rabe, G. C. Zaharie, A. Pellicer

Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters

Estee P. M. Lau, Matthew Ing, Sona Vekaria, Ai Ling Tan, Chloe Charlesworth, Edward Fysh, Ranjan Shrestha, Elaine L. C. Yap, Nicola A. Smith, Benjamin C. H. Kwan, Tajalli Saghaie, Bapti Roy, John Goddard, Sanjeevan Muruganandan, Arash Badiei, Phan Nguyen, Mohamed Faisal Abdul Hamid, Vineeth George, Deirdre Fitzgerald, Nick Maskell, David Feller-Kopman, Kevin Murray, Aron Chakera, Y C Gary Lee

Safety and efficacy of ketorolac in improving the prognosis of acute type A aortic dissection patients: a protocol of a randomized, double-blinded, and placebo-controlled study

Zhikang Lv, Tuo Pan, Haitao Zhang, Yapeng Wang, Yusanjian Matniyaz, Yuxian Tang, Lichong Lu, Dongjin Wang

  • Open Access
  • Study protocol

Vitamin D as an intervention for improving quadriceps muscle strength in patients after anterior cruciate ligament reconstruction: study protocol for a randomized double-blinded, placebo-controlled clinical trial

Michael Tim-yun Ong, Xiaomin Lu, Ben Chi-yin Choi, Siu-Wai Wan, Qianwen Wang, Gene Chi-wai Man, Pauline Po-yee Lui, Daniel Tik-Pui Fong, Daniel Kam-wah Mok, Patrick Shu-hang Yung

Effectiveness of personalized meal recommendation in improving dietary behaviors of Chinese community-dwelling elders: study protocol for a cluster randomized controlled trial

Zidu Xu, Xiaowei Xu, Lianglong Sun, Zhen Guo, Jianqiang Lai, Lin Kang, Jiao Li

Correction: Engaging Black youth in depression and suicide prevention treatment within urban schools: study protocol for a randomized controlled pilot

Michael A. Lindsey, Laura Mufson, Carolina Vélez‑Grau, Tracy Grogan, Damali M. Wilson, Aaron O. Reliford, Meredith Gunlicks‑Stoessel, James Jaccard

Effects of task-based mirror therapy on upper limb motor function in hemiplegia: study protocol for a randomized controlled clinical trial

Hongzhen Liu, Yangjie Xu, Wei Jiang, Fangchao Hu, Yi Zhou, Lu Pan, Feng Zhou, Ying Yin, Botao Tan

How inclusive were UK-based randomised controlled trials of COVID-19 vaccines? A systematic review investigating enrolment of Black adults and adult ethnic minorities

Hibba Herieka, Daphne Babalis, Evangelia Tzala, Shyam Budhathoki, Nicholas A. Johnson

Remote or in-clinic? The effect of service delivery mode on hearing aid output: study protocol for a double-blinded, randomised trial in adults with mild to moderate sensorineural hearing loss

Craig Lett, David Welch, Rosie Dobson

Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation

Emma McNaught, Sophie Reale, Liam Bourke, Janet E. Brown, Michelle Collinson, Florence Day, Jenny Hewison, Amanda J. Farrin, Saïd Ibeggazene, Aidan Q. Innes, Ellen Mason, David Meads, Alison Scope, Chris Taylor, Steph JC. Taylor, Rebecca R. Turner, Derek J. Rosario

The World Health Organization Antenatal CorTicosteroids for Improving Outcomes in preterm Newborns (ACTION-III) Trial: study protocol for a multi-country, multi-centre, double-blind, three-arm, placebo-controlled, individually randomized trial of antenatal corticosteroids for women at high probability of late preterm birth in hospitals in low- resource countries

Temitope Adesiji Adegboyega, Ebunoluwa Aderonke Adejuyigbe, Olubukola Adeponle Adesina, Babalola Adeyemi, Salahuddin Ahmed, Francis Akinkunmi, Jalemba Aluvaala, Henry Anyabolu, Shabina Ariff, Sugandha Arya, Ibraheem Awowole, Adejumoke Idowu Ayede, Neelofur Babar, Sumitra Bachani, Rajiv Bahl, Abdullah H. Baqui, Harish Chellani, Saleha Begum Chowdhury, Lynn M. Coppola, Simon Cousens, Pradeep K. Debata, Ayesha de Costa, Sangappa M. Dhaded, Kasturi V. Donimath, Adegoke Gbadegesin Falade, Shivaprasad S. Goudar, Shuchita Gupta, George N. Gwako, Theresa Azonima Irinyenikan, Dennis Anthony Isah, Nigar Jabeen, Arshia Javed, Naima T. Joseph, Rasheda Khanam, John Kinuthia, Oluwafemi Kuti, Tina Lavin, Ahmed R. Laving, Sandhya Maranna, Nicole Minckas, Pratima Mittal, Diwakar Mohan, Sidrah Nausheen, My Huong Nguyen, Olufemi T. Oladapo, Olanike Abosede Olutekunbi, Rosena Olubanke Oluwafemi, Alfred Osoti, Yeshita V. Pujar, Zahida P. Qureshi, Suman P. N. Rao, Sophie Sarrassat, M. A. Shahed, Mohammod Shahidullah, Lumaan Sheikh, Manjunath S. Somannavar, Sajid Soofi, Jyotsna Suri, Sunil S. Vernekar, Joshua P. Vogel, Nitya Wadhwa, Prakash K. Wari, Fred Were, Blair J. Wylie

Probiotic supplementation and risk of necrotizing enterocolitis and mortality among extremely preterm infants—the Probiotics in Extreme Prematurity in Scandinavia (PEPS) trial: study protocol for a multicenter, double-blinded, placebo-controlled, and registry-based randomized controlled trial

Sofia Söderquist Kruth, Carl Willers, Emma Persad, Elisabeth Stoltz Sjöström, Susanne Rautiainen Lagerström, Alexander Rakow

  • Open Access
  • Letter

Designing greener participant-centred trials: an analysis of ‘carbon relevant’ factors within items that influence participants’ decisions about trial recruitment and retention

Emilia Piltonen, Beatriz Goulao, Katie Gillies

The (cost-)effectiveness of early intervention (MBT-early) versus standard protocolized treatment (CBT) for emerging borderline personality disorder in adolescents (the EARLY study): a study protocol for a randomized controlled trial

Melissa G. A. Remeeus, Sharon L. Clarke, Dine J. Feenstra, Hester Van Eeren, Maaike L. Smits, Sara Debruyne, Mirjam E. J. Kouijzer, Patrick Luyten, Ron H. J. Scholte, Joost Hutsebaut

Educational nutritional intervention to prevent loss of health-related quality of life among older adults after a surgical treatment: design of a randomised controlled trial

Monica Christin Hansen, Lisbeth Uhrenfeldt, Kari Ingstad, Preben U. Pedersen

  • Open Access
  • Review

A methodological review of randomised n-of-1 trials

Olivia Hawksworth, Robin Chatters, Steven Julious, Andrew Cook, Katie Biggs, Kiera Solaiman, Michael C. H. Quah, Sxe Chang Cheong

  • Open Access
  • Study protocol

Study protocol for a randomized controlled trial of the Parent–Child Assistance Program: a case management and home visiting program for people using substances during pregnancy

Erin J. Maher, Susan A. Stoner, Julie Gerlinger, A. C. Ferraro, Heather Lepper-Pappan

Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: study protocol for a randomised controlled trial

Vishal C. Patel, Mark J. McPhail, Ruhama Uddin, Hassan Jafari, Vanessa Lawrence, Clair Le Boutillier, James Shearer, Nahel Yaziji, Angela Cape, Haroon Ahmed, Christopher Ward, Peter Walsh, Kevin Besly, Ane Zamalloa, Joanna Kelly, Ashis Mukhopadhya, Alicija Vileito, Tracy Henderson, Gwilym Webb, Jerrian Joyce Andrada, Abigail Ford, Cyril Sieberhagen, Claire Burston, Carol Brooks, Gavin Wright, Bushena Miyesa, Aimee Williams, Jay Patel, Melchizedek Penacerrada, Gautham Appanna, Gifthy Perez, Joanne Elliott, Keval Naik, Susan Smolen, Anna Beckwith, Matthew Foxton, Carina Bautista, Matthew Cramp, Ada Laureen Nweze, Gayatri Chakrabarty, Indhuja Rajkumar, Merlin James, Steven Masson, Sheenu Thomas, Lucy Dixon, Sarah Hogg, Louise Finlay, Kuldeep Cheent, Jessica Camp, Adrian Stanley, Alexis Duncan, Lauren Walker, Duncan Napier, Paula Hilltout, Linda Hill, Hiromi Uzu, Moby Joseph, Suzannah Pegler, Camille Walling, Lynsey Corless, Anisoara Kingsbury, Tania Nurun, Debasish Das, Anna Williams, Stephen Foley, Camelia Goodwin, Markus Gess, Margaret Grout, Ka-Kit Li, Olivia Watchorn, Laura Plummer, Laura Blackmore, Christos Tsintikidis, Allysha Perryman, George Bird, Emily Phiri, Mohamed Saleh, Adaze Woghiren, Dilukshi Wickramasinghe, Jodie Wright, Michael Miller, Shona Murray, Leanne Cosgrove, John Hutchinson, Julie Burton, Emma Stoner, Stephanie Lupton, Mayur Kumar, Nicola Griffiths, Anna Posada, Andrew Fowell, Avisnata Das, Jincy Daniel, Anu Rose Andrews, Dhiraj Tripathi, Emma Burke, Emma Eaves, Helen Emms, Dina Mansour, Ann Wilson, Maureen Armstrong, Rachael Swann, Faye McMeeken, Shona Perry, Naaventhan Palaniyappan, Elizabeth Davies, Kimberley Noon, Danielle Adebayo, Sarosh Khymani, Deepa Thapa, Mahesh Bhalme, Emma McKenna, Julie Chadwick, Jo Tod, Nina Barratt, Annamaria Wilce, Andrew Austin, Catherine Addleton, Ben Hudson, Rob James, Lily Zitter, Jane Hall, Jennifer Ryan, Christine Eastgate, Edward Britton, Martina Lofthouse, Vikram Sharma, James Hand, Louise Payaniandy, Paula Bravo, Marinos Pericleous, Sheila Mtuwa, Wisdom Mbama, Khaleel Jamil, Sumita Verma, Yaz Hassadin, Zhengmei He, Zdenka Cipinova, Roger McCorry, Allison Lloyd, Heather Lawther, Zeino Zeino, Lana Ward, Trudie Burge, Sarah Hughes, Joseph Delo, Criscel Jan Pelaez, David Whitley, Ameet Dhar, Nowlan Selvapatt, Maria Lanoria, Phil Berry, Sreelakshmi Kotha, Jessica Cordle, Ankita Sunny, Rohit Sinha, Louise Fairlie, Jennifer Henderson, Darren Craig, Eman Alabsawy, Julie Tregonning, Luke Summers, Sophy Booth, Esther Unitt, Susan Dale, Francisco Porras Perez, Melanie Kent, Suzanne Naylor, Tom Pembroke, Danielle Rice, Mohammed Shariff, Xiaobei Zhao, Varinder Athwal, Alphonsa Biju, Sheetal Crasta, Ben Carter

Schema therapy versus treatment as usual for outpatients with difficult-to-treat depression: study protocol for a parallel group randomized clinical trial (DEPRE-ST)

Ida-Marie T. P. Arendt, Matthias Gondan, Sophie Juul, Lene Halling Hastrup, Carsten Hjorthøj, Bo Bach, Poul Videbech, Martin Balslev Jørgensen, Stine Bjerrum Moeller

  • Open Access
  • Denture
  • Study protocol

3D printing vs traditional workflow for the fabrication of mandibular implant overdentures: study protocol for a mixed-methods cross-over RCT

Dana Jafarpour, Nesma El-Amier, Jocelyne Feine, Christophe Bedos, Samer Abi-Nader, Shahrokh Esfandiari, Tibor Shuster, Elizabeth Zimmermann, Raphael de Souza

LapEmerge trial: study protocol for a laparoscopic approach for emergency colon resection—a multicenter, open label, randomized controlled trial

Marie T. Grönroos-Korhonen, Jyrki A. O. Kössi

Theta-burst rTMS in schizophrenia to ameliorate negative and cognitive symptoms: study protocol for a double-blind, sham-controlled, randomized clinical trial

Gábor Csukly, Boglárka Orbán-Szigeti, Karolin Suri, Réka Zsigmond, Levente Hermán, Viktória Simon, Anita Kabaji, Barnabás Bata, Péter Hársfalvi, Edit Vass, Éva Csibri, Kinga Farkas, János Réthelyi

Haem iron versus ferrous iron salts to treat iron deficiency anaemia in Gambian children: protocol for randomised controlled trial {1}

Mamadou Bah, Hans Verhoef, Emmanuel Okoh, Abdoulie Bah, Andrew M. Prentice, Carla Cerami

  • Open Access
  • Commentary

A maturity model for the scientific review of clinical trial designs and their informativeness

S Dolley, T Norman, D McNair, D Hartman

Tolerance induction through early feeding to prevent food allergy in infants and children with sensitization against food allergens (TIFFANI): rationale, study design, and methods of a randomized controlled trial

Birgit Kalb, Lara Meixner, Stephanie Heller, Sabine Dölle-Bierke, Stephanie Roll, Tatjana Tissen-Diabaté, Susanne Lau, Sofia Forslund, Ingo Marenholz, Young-Ae Lee, Andreas Thiel, Magda Babina, Jörg Scheffel, Margitta Worm, Kirsten Beyer

  • Open Access
  • Laser
  • Study protocol

Photocoagulation or sham laser in addition to conventional anti-VEGF therapy in macular edema associated with TelCaps due to diabetic macular edema or retinal vein occlusion (TalaDME): a study protocol for a multicentric, French, two-group, non-commercial, active-control, observer-masked, non-inferiority, randomized controlled clinical trial

Bénédicte Dupas, Daniela Castro-Farias, Jean-François Girmens, Ali Eginay, Aude Couturier, Frederic Villeroy, Marie-Noëlle Delyfer, Catherine Creuzot-Garcher, Audrey Giocanti-Auregan, Laurence Béral, Carl Arndt, Charles Mesnard, Eric Vicaut, Philippe Chaumet-Riffaud, Isabelle Durand-Zaleski, Michel Paques

The translocator protein 18kDa ligand etifoxine in the treatment of depressive disorders—a double-blind, randomized, placebo-controlled proof-of-concept study

Lisa-Marie Brunner, Marco Riebel, Simon Wein, Michael Koller, Florian Zeman, Gunnar Huppertz, Tanja Emmer, Yvonne Eberhardt, Jens Schwarzbach, Rainer Rupprecht, Caroline Nothdurfter

Efficacy of Wearable low-intensity pulsed Ultrasound treatment in the Movement disorder in Parkinson’s disease (the SWUMP trial): protocol for a single-site, double-blind, randomized controlled trial

Chuanyu Zhong, Ning Guo, Canfang Hu, Ruilong Ni, Xiaojie Zhang, Zheying Meng, Taotao Liu, Siqi Ding, Wanhai Ding, Yuwu Zhao, Li Cao, Yuanyi Zheng

The clinical value of mNGS of bronchoalveolar lavage fluid versus traditional microbiological tests for pathogen identification and prognosis of severe pneumonia (NT-BALF):study protocol for a prospective multi-center randomized clinical trial

Xiao Song, Hui Jiang, Liang Zong, Di Shi, Huadong Zhu

Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention

Anne Søjbjerg, Anna Mygind, Stinne Eika Rasmussen, Bo Christensen, Anette Fischer Pedersen, Helle Terkildsen Maindal, Viola Burau, Kaj Sparle Christensen

Coordination of COVID-19 platform trials in Europe

Jacques Demotes, Victoria Charlotte Simensen, Keiko Ueda, Sareema Javaid, Paula Garcia, Burç Aydin, John-Arne Røttingen

The effectiveness of pharmacist-led educational model in adult patients with allergic rhinitis: a single-center randomized control trial protocol (AR-PRISE RCT)

Chii-Chii Chew, Xin-Jie Lim, Pathma Letchumanan, Doris George, Philip Rajan, Chee Ping Chong

  • Open Access
  • Update

Statistical analysis plan for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2)

Nicholas Magill, Siddharudha Shivalli, Ila Fazzio, Diana Elbourne, Suzanne Keddie, Padmanabh Reddy, Rakhi Nair, Madan Gopal, Sridevi Karnati, Harshavardhan Reddy, Peter Boone, Chris Frost

  • Open Access
  • Research

Shining a spotlight on the inclusion of disabled participants in clinical trials: a mixed methods study

Yoshiko Sakuma, Marie L. E. Miller, Daphne S. Babalis, Alex Baker, Meena Reddi, Aisha Anjum, Jane Bruton, Kathryn N Jones, Umm Zeinab Mulla, Henock Taddese

Adjustment of positive end-expiratory pressure to body mass index during mechanical ventilation in general anesthesia: BodyVent, a randomized controlled trial

Helene Selpien, Christine Eimer, David Thunecke, Jann Penon, Dirk Schädler, Ingmar Lautenschläger, Henning Ohnesorge, Tobias Becher

Community Health workers United to Reduce Colorectal cancer and cardiovascular disease among people at Higher risk (CHURCH): study protocol for a randomized controlled trial

Olajide Williams, Tina Ting, Lisa Matthews, Gladys Block, Torin Block, Jeanne Teresi, Joseph Eimicke, Jian Kong, Stephanie Silver, Joseph Ravenell, Janhavi Mallaiah, Soujanya Jammalamadaka, Laura Maudene Nelson, Wahida Karmally, Sidney Hankerson

Gamma oscillations induced by 40-Hz visual-auditory stimulation for the treatment of acute-phase limb motor rehabilitation after stroke: study protocol for a prospective randomized controlled trial

Wang Fu, Xiaoming Yu, Minghui Lai, Yuanli Li, Yingting Yang, Yong Qin, Min Yu, Feng Wang, Cong Wang

Effects of different treatment frequencies of electromagnetic stimulation for urinary incontinence in women: study protocol for a randomized controlled trial

Chunmei Chen, Jing Zhang, Hong Zhang, Haiyan Li, Jucheng Yu, Yao Pei, Yuan Fang

Assessing fragility of statistically significant findings from randomized controlled trials assessing pharmacological therapies for opioid use disorders: a systematic review

Leen Naji, Brittany Dennis, Myanca Rodrigues, Monica Bawor, Alannah Hillmer, Caroul Chawar, Eve Deck, Andrew Worster, James Paul, Lehana Thabane, Zainab Samaan

Anterior chamber proliferative membrane interception (AC-PMI)-enhanced trabeculectomy versus trabeculectomy for treating neovascular glaucoma: protocol for a randomized controlled trial

Shuqing Zhu, Mengtian Zhou, Haoyu Li, Shaodan Zhang, Shuxia Xu, Haishuang Lin, Yanqie Xie, Rongrong Le, Yuanbo Liang

Hypotension prediction index guided goal-directed therapy to reduce postoperative acute kidney injury during major abdominal surgery: study protocol for a multicenter randomized controlled clinical trial

Javier Ripollés-Melchor, Laura Carrasco-Sánchez, José L. Tomé-Roca, César Aldecoa, Andres Zorrilla-Vaca, Juan V. Lorente-Olazábal, María J. Colomina, Ana Pérez, Juan I. Jiménez-López, Rosalía Navarro-Pérez, Alfredo Abad-Gurumeta, Manuel I. Monge-García, Alicia Ruiz-Escobar, Paula Fernánez-Valdes-Bango, Ángel V. Espinosa, María A. Fuentes Pradera, Azahara Cortes Rueda, Ana B. Adell-Perez, Iker Agarrista-Aguirrezabala, Marta Amelburu-Egoscozabal, Josu Ariño-Larrañaga, Aitor de Haro-Ferrari, Manuel Eced-Sanchez, Maria Eizaguirre-Cotado, Alazne Enparantza-Aiestaran, Cristina Garcia-Fernandez, Carmen Garicano-Goldaraz, Nuria Gonzalez-Jorrin, Silvia Gonzalez-Santos, Andrea Lara-Jimenez, Edurne Lodoso-Ochoa, Amaia Lopetegui-Aizpurua, Jorge Mendoza-Sorrondegi, Antia Osorio-Lopez, Amaia Uria-Azpiazu, Virginia Serrano Zarcero, Ane Abad-Motos, Hussein Abu Khudair, Rocío Venturoli Ojeda, Alvaro Mingote-Lladó, Diego Gutiérrez-Martínez, Alberto Gutiérrez-Martínez, Ana Moreno Martín, Javier García-Fernández, Bartolomé Fernández Torres, Ignacio Martin de Pablos, Javier María Valiente Lourtau, Estefanía Peralta Espinosa, Jose Manuel Prieto Gutiérrez, Víctor Lama Paniego, Ángel Cárdenas Duque, Ángel Becerra-Bolaños, Carmen A. Focaccio-Tejada, Aurelio Rodríguez-Pérez, Sergio López-Ruiz, Lucía Valencia-Sola, Patricia Galán-Menéndez, Daniel García-López, Marc Sadurni-Sarda, Hugo Rivera-Ramos, Irene Romero-Bhathal, Laura Castelltort-Masco, Carlos E. Moreno-Martinez, Jesus Carazo-Cordobes, Leire Larrañaga-Altuna, Eva Bassas-Parga, Ana Tejedor-Navarro, Jesús Fernanz-Antón, Marta Garcia-Martínez, Aleix Carmona-Blesa, Elisenda Pujol-Rosa, J. Miquel Moncho-Rodríguez, Luisa F. Cueva-Castro, Astrid M. Batalla-González, Marta Giné-Servén, María M. Bastitta, Laura A. Pardo-Pinzón, Alex Arjona-Navarro, Gonzalo Azparren-Cabezón, Alejandro Gutiérrez-Marqués, Alejandro García-Rodriguez, Adriano Paz-Martín, Daniel García-López, Gina Lladó-Jordan, José L. Rábago-Moriyón, Ceferina Suárez-Castaño, Ana Bolado-Álvarez de Eulate, Gabriel Escudero-Gómez, Julia Castaño-Álvarez, Eduardo Larraz-Mármol, Rodrigo Sancho-Carrancho, Marta Alonso-Fernández, Irma M. Barrio-Pérez, Nel González-Argüelles, Sara Martínez-Álvarez, Adriana I. Reyes-Echeverría, Guillermo Tejón-Pérez, Ángela Pascual-Casado, Pablo Garmilla-Ezquerra, Angel Villar Pellit de la Vega, Santiago Seco Gordillo, Ana M. Quintero Moreno, Peña Gómez Domínguez, Irene Mojarro, Jordi Llorca García, Francisco J. Cañas Perea, Cristina Prat Llimargas, Pere Esquius Jofré, Santiago Montesinos-Fadrique, Gabriel Yanes, Alvaro Ocón-Moreno, Samuel Moreno-Jiménez, Alberto Quevedo-Gutiérrez, Miguel Medina-Martos, Laura Herrera-Lozano, Sandra L. Martín-Infantes, Carlos M. Palacios-Vega, Cesar P. Garcia-Bertini, Ángela Salinas-Moya, Rocío Venturoli, Ana Moreno, Adrián Muñoz, Pablo Lobato, Montserrat Mallol, Andrea Gutierrez, Antonio Guillen, Ana Mugarra, Berta Monleón, Ana Gimeno, Esther Romero, Eduardo Passariello, Carmen Beltran, Eva Rivas, Marta Ubré, Beatriz Tena, Óscar Comino, Iago Dieguez, Miren A. Echevarria-Correas, Maite Chasco-Ganuza, Mercedes Olvera-García, Alejando Arrabal, Marta Díaz, Marta Caballero-Milan, Guillermo Alonso-Nadal, Guillermo Puig-Sanz, Antonio-Jose Navarro-Garcia, Marc Cebria-Fondevila, Míriam Millan-Ruiz, Wanyi Li, Neus Sagartal, Tatiana Dam, Jaume Puig, L. Alós-Zaragozá, MA. Pallárdó-López, Marta Rosselló-Chornet, L. Munoz-Devesa, MJ. Hernández-Cádiz, J. Hernández-Laforet, R. Sanchis, Martin, E. Biosca-Pérez, Y. Fernández, Laura Vaquero, David Laguna, Alba Diaz, Alicia Bordell, Esther Aguado, Delia Velasco, Eugenio Ruiz, María Garcia-Matesanz, Irene Arranz, María Jesus Sanz de Leon, Maria-Jose Blanco, Gerardo Arias-Cuesta, Amal Azzam-López, María C. Martín-González, Isabel Ruíz-Torres, Pablo Racionero-González, Jimena Escobar-Tapias, Alba Gonzalo-Millán, Yolanda Diez Remesal, José L. Garrido, Anna Arnau-Bartés, Francesca Reguant-Corominas, Laura Dos-Santos-Carregal, Sabela del-Río, Gema Curado-Zafra, Paola Saiz-Sánchez, Isabel Paniagua-Pacheco, Ángela Morales-Cubero, José L. Garrido-Calmaestra, Miguel A. Valbuena-Bueno, Ana Pedregosa-Sanz, Santiago Abreu-Paradell, Pau Vallhonrat-Alcántara, Anna Alonso-Manzano, Carolina Palma, Martí Esteban-Fernández, Luis Nassar-Clavijo, Ahmad Alraqqab, Zaid Ayesh, Hussein Abu Khudair, Abderrahman Barhoum, Murad Al-Kharabsheh

Adherence and acceptability of multiple micronutrient supplementation during pregnancy: Study protocol for a cluster-randomized non-inferiority trial in Cambodia

Mai-Anh Hoang, Hou Kroeun, Rolf Klemm, Aman Sen Gupta, Ngik Rem, Sokchea Meng, Sophonneary Prak, Kim Rattana, Mary Chea, Crystal D. Karakochuk, Cassandra Sauer, Ashutosh Mishra, Diwakar Mohan, Meredith Jackson de-Graffenried

  • Open Access
  • Study protocol

Miracle friends and miracle money in California: a mixed-methods experiment of social support and guaranteed income for people experiencing homelessness

Benjamin F. Henwood, Bo-Kyung Elizabeth Kim, Amy Stein, Gisele Corletto, Himal Suthar, Kevin F. Adler, Madeline Mazzocchi, Julia Ip, Deborah K. Padgett

  • Open Access
  • Study protocol

Targeting strategies of antenatal balanced energy and protein supplementation in Addis Ababa, Ethiopia: study protocol for a randomized effectiveness study

Dongqing Wang, Tigest Shifraw, Janaina Calu Costa, Semira Abdelmenan, Sitota Tsegaye, Yoseph Berhane, Hanna Gulema, Hanna Berhane, Nebiyou Fasil, Firehiwot Workneh, Workagegnhu Tarekegn, Molin Wang, Nicolas A. Menzies, Alemayehu Worku, Yemane Berhane, Wafaie W. Fawzi

  • Open Access
  • Research

When describing harms and benefits to potential trial participants, participant information leaflets are inadequate

Laura Cuddihy, Jeremy Howick, Ellen Murphy, Frances Shiely

Medicinal Cannabis (MedCan 3): a randomised, multicentre, double-blind, placebo-controlled trial to assess THC/CBD (1:20) to relieve symptom burden in patients with cancer—a study protocol for a randomised controlled trial

Taylan Gurgenci, Janet Hardy, Georgie Huggett, Karyn Foster, Anita Pelecanos, Ristan Greer, Jennifer Philip, Alison Haywood, Ruwani Mendis, Patsy Yates, Phillip Good

Comparative evaluation of intensified short course regimen and standard regimen for adults TB meningitis: a protocol for an open label, multi-center, parallel arms, randomized controlled superiority trial (INSHORT trial)

Leeberk Raja Inbaraj, Abi Manesh, C. Ponnuraja, Adhin Bhaskar, Vignes Anand Srinivasalu, Bella Devaleenal Daniel

  • Open Access
  • Correction

Correction: Community-based integrated care for patients with diabetes and depression (CIC-PDD): study protocol for a cluster randomized controlled trial

Yanshang Wang, Dan Guo, Ming Wang, Mingzheng Hu, Dawei Zhu, Qianqian Yu, Zhansheng Li, Xiaoyi Zhang, Ruoxi Ding, Miaomiao Zhao, Ping He

Statistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial

Yaseen M Arabi, Hasan M. Al-Dorzi, Omar Aldibaasi, Musharaf Sadat, Jesna Jose, Dina Muharib, Haifa Algethamy, Abdulrahman A. Al-Fares, Fahad Al-Hameed, Ahmed Mady, Ayman Kharaba, Ali Al Bshabshe, Khalid Maghrabi, Khalid AlGhamdi, Ghulam Rasool, Adnan AlGhamdi, Ghaleb. A Almekhlafi, Jamal Chalabi, Haifaa Ibrahim AlHumedi, Maram Hasan Sakkijha, Norah Khalid Alamrey, Amjad Sami Alaskar, Rabeah Hamad Alhutail, Kaouthar Sifaoui, Rakan Alqahtani, Ahmad S. Qureshi, Mohammed Moneer Hejazi, Hatim Arishi, Samah AlQahtani, Amro Mohamed Ghazi, Saleh T. Baaziz, Abeer Othman Azhar, Sara Fahad Alabbas, Mohammed AlAqeely, Ohoud AlOrabi, Aliaa Al-Mutawa, Maha AlOtaibi, Madiha Fawazy Elghannam, Mohammed Almaani, Sarah Fadel Buabbas, Wadiah Alawi M. Alfilfil, Mohammed S. Alshahrani, Joel Starkopf, Jean-Charles Preiser, Anders Perner, Jumana Hani AlMubarak, Wafa Mansoor Hazem, Talal Albrahim, Abdulaziz Al-Dawood, Amal Almatroud, Brintha Naidu, Vicki Burrow, Salha Al Zayer, Haseena Banu Khan, Afonso Varela, Hatim Arishi, Mohammed Moneer Hejazi, Mohamed Ali Alodat, Rayan Alshayeh, AbdulRehman AlHarthi, Naif Al Qahtani, Yasmeen Ayed AlHejiely, Mada Muzhir AlZahrani, Mohammed Haddad Lhmdi, Nouf AlBakhiet, Katrina Baguisa, Huda Mhawisg, Haifa Alghethamy, Liyakat Khan, Moataz Gabr, Shehla Nuzhat, Ohoud AlOrabi, Raghad Malabari, Kholoud Shobragi, Shaymaa Asaas, Madiha Fawazy Elghannam, Beverly Bcuizon, Bander AlAnezi, Christine Joy Anaud, Munir AlDammad, Yahia Otaif, Osama Hakami, Arwa AlHusseini, Shahinaz Bashir, Lama Hefni, Samahar Alamoudi, Milyn L. Ansing, Sawsan Albalawi, Manar Alahmadi, Mohammed AlHumaid, Samar Talal Nouri, Rozeena Huma, Khawla Farhan, Mohamed Hussein, Olfa Baji, Abdulrehman Alerw, Khloud Johani, Monera AlEnezi, Ismail Boudrar, Rabiah Atiq, Maali Junid, Maram Yusef, Ahmed Quadri, Khalid Idrees, Mona Bin Mabkoot, Wadiah Alawi Alfilfil, AbdulRehman Fahad Alkraidees, Laila Perlas Asonto

  • Open Access
  • Correction

Correction: Methodology of the SORENTO clinical trial: a prospective, randomised, active-controlled phase 3 trial assessing the efficacy and safety of high exposure octreotide subcutaneous depot (CAM2029) in patients with GEP-NET

Simron Singh, Diego Ferone, Jaume Capdevila, Jennifer Ang Chan, Wouter W. de Herder, Daniel Halperin, Josh Mailman, Lisa Hellström, Hanna Liedman, Agneta Svedberg, Fredrik Tiberg

The effect of focused lung ultrasonography on antibiotic prescribing in patients with acute lower respiratory tract infections in Danish general practice: study protocol for a pragmatic randomized controlled trial (PLUS-FLUS)

Julie Jepsen Strøm, Camilla Aakjær Andersen, Martin Bach Jensen, Janus Laust Thomsen, Christian B. Laursen, Søren Helbo Skaarup, Hans Henrik Lawaetz Schultz, Malene Plejdrup Hansen

Mindfulness-based intervention for hypertension patients with depression and/or anxiety in the community: a randomized controlled trial

Hailiang Zhang, Xiangrong Zhang, Xiaomei Jiang, Runjing Dai, Na Zhao, Weimin Pan, Jiaohong Guo, Jingchun Fan, Shisan Bao

Bent ab interno needle goniotomy versus gonioscopy-assisted transluminal trabeculotomy in primary open-angle glaucoma: study protocol of a randomized clinical trial

Gabriel Ayub, Ticiana De Francesco, Vital Paulino Costa

Comparing niraparib versus platinum-taxane doublet chemotherapy as neoadjuvant treatment in patients with newly diagnosed homologous recombination–deficient stage III/IV ovarian cancer: study protocol for cohort C of the open-label, phase 2, randomized controlled multicenter OPAL trial

Jimmy Belotte, Brunella Felicetti, Amanda J. Baines, Ahmed YoussefAgha, Luis Rojas-Espaillat, Ana Godoy Ortiz, Diane Provencher, Raúl Márquez Vázquez, Lucia González Cortijo, Xing Zeng

Brief Educational Workshops in Secondary Schools Trial (BESST trial), a school-based cluster randomised controlled trial of the DISCOVER workshop for 16–18-year-olds: recruitment and baseline characteristics

Kirsty James, Stephen Lisk, Chloe Payne-Cook, Zamena Farishta, Maria Farrelly, Ayesha Sheikh, Monika Slusarczyk, Sarah Byford, Crispin Day, Jessica Deighton, Claire Evans, Peter Fonagy, David Saunders, Irene Sclare, James Shearer, Paul Stallard, Timothy Weaver, Jynna Yarrum, Ben Carter, June S. L. Brown

Refraining from closed reduction of displaced distal radius fractures in the emergency department—in short: the RECORDED trial

B. M. Derksen, P. A. Jawahier, O. Wijers, S. P. Knops, M. R. de Vries, C. C. Drijfhout van Hooff, M. H. J. Verhofstad, N. W. L. Schep

  • Open Access
  • Study protocol

PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC): protocol for an effectiveness cluster randomised controlled trial

Anette Væringstad, Ellen Thea Gjelseth Dalbak, Daniela Holle, Janne Myhre, Øyvind Kirkevold, Sverre Bergh, Bjørn Lichtwarck

Hidden blood loss and the influential factors after minimally invasive treatment of posterior pelvic ring injury with sacroiliac screw

Ding Xu, Min Liu, Weigang Lou, Ming Li, Jingwei Xiao, Hongbao Wu, Yunqiang Zhuang, Jianming Chen

  • Open Access
  • Study protocol

The effect of oral motor intervention with different initiation times to improve feeding outcomes in preterm infants: protocol for a single-blind, randomized controlled trial

Yingxin Li, Yanlin Hu, Yuan Li, Xia Li, Xi Huang, Zeyao Shi, Ru Yang, Xiujuan Zhang, Qiong Chen

Investigating the effects of synbiotic supplementation on functional movement, strength and muscle health in older Australians: a study protocol for a double-blind, randomized, placebo-controlled trial

David J. Barry, Joshua B. Farragher, Andrew C. Betik, Jackson J. Fyfe, Lilia Convit, Matthew B. Cooke

Personalized mechanical ventilation guided by ultrasound in patients with acute respiratory distress syndrome (PEGASUS): study protocol for an international randomized clinical trial

Jante S. Sinnige, Marry R. Smit, Aniruddha Ghose, Harm-Jan de Grooth, Theis Skovsgaard Itenov, Eleni Ischaki, John Laffey, Frederique Paulus, Pedro Póvoa, Charalampos Pierrakos, Luigi Pisani, Oriol Roca, Marcus J. Schultz, Konstanty Szuldrzynski, Pieter R. Tuinman, Claudio Zimatore, Lieuwe D. J. Bos, A. K. M. Arif Uddin Ahmed, Mohammad Jhahidul Alam, Mohsammad Rafiqual Alam, Anjan Bal, Samarjit Barua, Rajdeep Biswas, Mohammed Abdur Rahaman Chowdhury, Safiqul Mostafa Chy, Satyajit Dhar, Pranay Kumar Dutta, Syeda Nafisa Khatoon, Ranjan Kumar Nath, Nahid Nowroz, Mithun Shil, Rachid Attou, Leonel Barreto Gutierrez, Keitiane Kaefer, Morten Bestle, Lars Hein, Thomas Hildebrandt, Jacob Jensen, Sanne Lauritzen, Ulf Pedersen, Lone Poulsen, Harry Giannopoulos, Katerina Vaporidi, Lauren Ferguson, Yvelynne Kelly, Sabina Mason, Aisling McMahon, Bairbre McNicholas, Daniele Biasucci, Gianmaria Cammarota, Maurizio Follino, Salvatore Grasso, Antonio Latela, Giovanna Magnesa, Fabrizia Massaro, Leonarda Maurmo, Marco Pezzuto, Savino Spadaro, Luigi Vetrugno, Massimo Zambon, Daan Filippini, Peter Klompmaker, Amne Mousa, Dominik Daszuta, Miłosz Jankowski, Irene Aragao, Heloisa Castro, Vasco Costa, Cristina Torrão, Toni Antoni, Marta Arroyo, Marta Briva, Nuria Duran, Marina García-de-Acilu, Gemma Goma, Ana Ochagavia, Michelle Chew, Mariangela Pellegrini, Gaetano Perchiazzi

Safety and efficacy of autologous adipose tissue-derived stem cell transplantation in aging-related low-grade inflammation patients: a single-group, open-label, phase I clinical trial

Ngoc-Huynh Ton Nguyen, Hao Thanh Phan, Phong Minh Le, Lan-Huong Thi Nguyen, Thuy Thi Do, Thien-Phuc Thanh Phan, Trinh Van Le, Thanh Minh Dang, Chinh-Nhan Lu Phan, Tung-Loan Thi Dang, Nhung Hai Truong

  • Open Access
  • Commentary

Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit

William J Cragg, Chris Taylor, Lauren Moreau, Howard Collier, Rachael Gilberts, Niamh McKigney, Joanna Dennett, Sandra Graca, Ian Wheeler, Liam Bishop, Adam Barrett, Suzanne Hartley, John P Greenwood, Peter P Swoboda, Amanda J Farrin

Testing novel strategies for patients hospitalised with HIV-associated disseminated tuberculosis (NewStrat-TB): protocol for a randomised controlled trial

Phiona E. Namale, Linda Boloko, Marcia Vermeulen, Kate A. Haigh, Fortuna Bagula, Alexis Maseko, Bianca Sossen, Scott Lee-Jones, Yoliswa Msomi, Helen McIlleron, Ayanda Trevor Mnguni, Thomas Crede, Patryk Szymanski, Jonathan Naude, Sakeena Ebrahim, Yakoob Vallie, Muhammed Shiraz Moosa, Ismail Bandeker, Shakeel Hoosain, Mark P. Nicol, Nazlee Samodien, Chad Centner, Wentzel Dowling, Paolo Denti, Freedom Gumedze, Francesca Little, Arifa Parker, Brendon Price, Denzil Schietekat, Bryony Simmons, Andrew Hill, Robert J. Wilkinson, Ida Oliphant, Siphokazi Hlungulu, Ivy Apolisi, Monica Toleni, Zimkhitha Asare, Mkanyiseli Kenneth Mpalali, Erica Boshoff, Denise Prinsloo, Francisco Lakay, Abulele Bekiswa, Amanda Jackson, Ashleigh Barnes, Ryan Johnson, Sean Wasserman, Gary Maartens, David Barr, Charlotte Schutz, Graeme Meintjes

  • Open Access
  • Methodology

Upstrapping to determine futility: predicting future outcomes nonparametrically from past data

Jessica L. Wild, Adit A. Ginde, Christopher J. Lindsell, Alexander M. Kaizer

  • Open Access
  • Study protocol

Pressure injury treatment by intermittent electrical stimulation (PROTECT-2): protocol for a multicenter randomized clinical trial

Chase Donaldson, Marcelo Gama de Abreu, Edward J. Mascha, James Rowbottom, Eric Harvester, Ashish Khanna, Tanmay Sura, Daniel I. Sessler, Fabio Rodriguez Patarroyo, Alper Gulluoglu, Paul Zajic, Utkarsh Chauhan, Hani Essber, Andrea Kurz

Refining physical exercise training studies in patients with inflammatory bowel disease: patient selection and assessment of physical fitness changes

Karlijn Demers, Bart C. Bongers, Daisy M. A. E. Jonkers, Marieke J. Pierik, Laurents P. S. Stassen

Targeting strategies for balanced energy and protein (BEP) supplementation in pregnancy: study protocol for the TARGET-BEP cluster-randomized controlled trial in rural Bangladesh

Eleonor Zavala, Diwakar Mohan, Hasmot Ali, Towfida J. Siddiqua, Rezwanul Haque, Kaniz Ayesha, Khalid Bin Ahsan, Hasan Mahmud Sujan, Nazrana Khaled, Atiya Rahman, Barnali Chakraborty, Brian Dyer, Lee S. F. Wu, Anna Kalbarczyk, Daniel J. Erchick, Andrew L. Thorne-Lyman, Alison Tumilowicz, Kaosar Afsana, Parul Christian

Efficacy of ganglion impar block combined with pudendal nerve pulsed radiofrequency for pudendal neuralgia management—a randomized clinical trial

Jiao Ran, Fan Lu, Le Xu, Yu Du, Li Liu, Tao Qi, Xiaoli Zhou, Yulin Zhang, Dong Liu, Rurong Wang, Xuehan Li

The left atrial appendage closure by surgery 2 trial: statistical analysis plan for a randomized multicenter trial exploring if the closure of the left atrial appendage during open-heart surgery reduces stroke irrespective of patients’ stroke risk and preoperative atrial fibrillation status

Christoffer L. Madsen, Jesper Park-Hansen, Rakin Hadad, Anders M. Greve, Helena Domínguez

  • Open Access
  • Letter

Training and education on inclusivity in clinical trials—the SENSITISE project

Frances Shiely, Jitka Rychlíčková, Christine Kubiak, Zora Čechová, Martina Esdaile, Shaun Treweek

  • Open Access
  • Study protocol

Evaluation of lived experience Peer Support intervention for mental health service consumers in Primary Care (PS-PC): study protocol for a stepped-wedge cluster randomised controlled trial

Sharon Lawn, Tania Shelby-James, Sam Manger, Louise Byrne, Belinda Fuss, Vivian Isaac, Billingsley Kaambwa, Shahid Ullah, Megan Rattray, Bill Gye, Christine Kaine, Caroline Phegan, Geoff Harris, Paul Worley

High-definition transcranial direct current stimulation (HD-tDCS) in major depressive disorder with anxious distress—a study protocol for a double-blinded randomized sham-controlled trial

Danwei Zhang, Bei Zhao, Xue Sun, Kaimo Ding, Jingjing Sun, Sheng Tao

  • Open Access
  • Fatigue
  • Study protocol

Comparing effectiveness of physiotherapy versus drug management on fatigue, physical functioning, and episodic disability for myalgic encephalomyelitis in post-COVID-19 condition: a study protocol of randomized control trial

Altaf Hossain Sarker, K.M. Amran Hossain, Md. Feroz Kabir, Sharmila Jahan, Md. Zahid Hossain, Tofajjal Hossain, Iqbal Kabir Jahid

  • Open Access
  • Study protocol

Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial

Johannes Carl, Eva Grüne, Johanna Popp, Verena Hartung, Klaus Pfeifer

  • Open Access
  • Research

Integrating qualitative research within a clinical trials unit: developing strategies and understanding their implementation in contexts

Jeremy Segrott, Sue Channon, Amy Lloyd, Eleni Glarou, Josie Henley, Jacqueline Hughes, Nina Jacob, Sarah Milosevic, Yvonne Moriarty, Bethan Pell, Mike Robling, Heather Strange, Julia Townson, C. Drew, D. Gillespie, R. Hale, J. Latchem-Hastings, R. Milton, B. Pell, H. Prout, V. Shepherd, K. Smallman, H. Stanton, Lucy Brookes-Howell

Comparison of apixaban versus aspirin for the prevention of latent bioprosthetic aortic valve thrombosis: study protocol for a prospective randomized trial

Tomislav Kopjar, Hrvoje Gasparovic, Maja Hrabak Paar, Daniel Lovric, Petra Cerina, Tomislav Tokic, Davor Milicic

Effectiveness of artificial intelligence vs. human coaching in diabetes prevention: a study protocol for a randomized controlled trial

Mohammed S. Abusamaan, Jeromie Ballreich, Adrian Dobs, Brian Kane, Nisa Maruthur, John McGready, Kristin Riekert, Amal A. Wanigatunga, Mary Alderfer, Defne Alver, Benjamin Lalani, Benjamin Ringham, Fatmata Vandi, Daniel Zade, Nestoras N. Mathioudakis

RECOVER-NEURO: study protocol for a multi-center, multi-arm, phase 2, randomized, active comparator trial evaluating three interventions for cognitive dysfunction in post-acute sequelae of SARS-CoV-2 infection (PASC)

David S. Knopman, Daniel T. Laskowitz, Deborah C. Koltai, Leigh E. Charvet, Jacqueline H. Becker, Alex D. Federman, Juan Wisnivesky, Henry Mahncke, Thomas M. Van Vleet, Lucinda Bateman, Dong-Yun Kim, Ashley O’Steen, Melissa James, Adam Silverstein, Yuliya Lokhnygina, Jennifer Rich, Bryan J. Feger, Kanecia O. Zimmerman

Superiority trial for the development of an ideal method for the closure of midline abdominal wall incisions to reduce the incidence of wound complications after elective gastroenterological surgery: study protocol for a randomized controlled trial

Shota Fukai, Yuki Mizusawa, Hiroshi Noda, Shingo Tsujinaka, Yukihisa Maeda, Ryuji Hasebe, Yusuke Eguchi, Rina Kanemitsu, Natsumi Matsuzawa, Iku Abe, Yuhei Endo, Taro Fukui, Yuji Takayama, Kosuke Ichida, Koetsu Inoue, Yuta Muto, Fumiaki Watanabe, Kazushige Futsuhara, Yasuyuki Miyakura, Toshiki Rikiyama

SCARLET (Supplemental Citicoline Administration to Reduce Lung injury Efficacy Trial): study protocol for a single-site, double-blinded, placebo-controlled, and randomized Phase 1/2 trial of i.v. citicoline (CDP-choline) in hospitalized SARS CoV-2-infected patients with hypoxemic acute respiratory failure

Sonal Pannu, Matthew C. Exline, Joseph S. Bednash, Joshua A. Englert, Philip Diaz, Amy Bartlett, Guy Brock, Qing Wu, Ian C. Davis, Elliott D. Crouser

ZOom Delivered Intervention Against Cognitive decline (ZODIAC) COVID-19 pandemic adaptations to the Post-Ischaemic Stroke Cardiovascular Exercise Study (PISCES): protocol for a randomised controlled trial of remotely delivered fitness training for brain health

Amy Brodtmann, Alex Billett, Rachael Telfer, Kim Adkins, Laura White, Laura J. E. McCambridge, Louise M. Burrell, Vincent Thijs, Sharon Kramer, Emilio Werden, Barbara R. Cardoso, Matthew Pase, Stanley Hughwa Hung, Leonid Churilov, Julie Bernhardt, Kathryn Hayward, Liam Johnson

Duloxetine and cognitive behavioral therapy with phone-based support for the treatment of chronic musculoskeletal pain: study protocol of the PRECICE randomized control trial

Dennis C. Ang, Swetha Davuluri, Sebastian Kaplan, Francis Keefe, Christine Rini, Christopher Miles, Haiying Chen

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya

Elena Marbán-Castro, Lorrein Muhwava, Yvonne Kamau, Elvis Safary, Paul Rheeder, Maria Karsas, Tanja Kemp, Johanè Freitas, Michelle Carrihill, Joel Dave, Daniel Katambo, Joan Kimetto, Razana Allie, Nancy Ngugi, Gaman Muhammed, Eva Njenga, Catherine Karekezi, Nancy Kunyiha, Newton Ngugi, Elizabeth Onyango, Amanda Mashego, Kirsten De Klerk, Salih Hendriks, Newton Ngugi, Bilqees Sayed, Joseph Ndungu, Ntombi Sigwebela, Dorcas Akach, Sarah Girdwood, Berra Erkosar, Brooke E. Nichols, Cathy Haldane, Beatrice Vetter, Sonjelle Shilton

4-Aminopyridine treatment for nerve injury resulting from radical retro-pubic prostatectomy: a single-center double-blind, randomized, placebo-controlled study

Ahmed Ghazi, Thomas L. Osinski, Changyong Feng, Andrea Horne, John Elfar

Telemedicine home-based management in patients with chronic heart failure and diabetes type II: study protocol for a randomized controlled trial

Palmira Bernocchi, Vittorio Giudici, Gabriella Borghi, Patrizia Bertolaia, Salvatore D’Isa, Roberto Trevisan, Simonetta Scalvini

High-precision stereotactic irradiation for focal drug-resistant epilepsy versus standard treatment: a randomized waitlist-controlled trial (the PRECISION trial)

C. M. L. Zegers, A. Swinnen, C. Roumen, A. L. Hoffmann, E. G. C. Troost, C. J. J. van Asch, L. Brandts, I. Compter, E. M. T. Dieleman, J. B. Dijkstra, M. Granzier, M. Hendriks, P. Hofman, R. M. A. Houben, B. Ramaekers, H. E. Ronner, R. P. W. Rouhl, S. van der Salm, R. G. C. Santegoeds, J. J. Verhoeff, G. L. Wagner, J. Zwemmer, OEMG Schijns, A. J. Colon, D. B. P. Eekers

  • Open Access
  • Suicide
  • Study protocol

Effectiveness of a school-based Life Gatekeeper Training Program on suicide prevention in China: protocol for a randomized controlled trial

Diyang Qu, Xuan Zhang, Dongyu Liu, Bowen Liu, Dongyang Chen, Chengxi Cai, Jing An, Shekhar Saxena, Runsen Chen

  • Open Access
  • Anxiety
  • Study protocol

Effect of MDMA-assisted therapy on mood and anxiety symptoms in advanced-stage cancer (EMMAC): study protocol for a double-blind, randomised controlled trial

Chiranth Bhagavan, Paul Glue, Will Evans, Lisa Reynolds, Thivya Turner, Chris King, Bruce R. Russell, Eva Morunga, Jessica Lee Mills, Geoff Layton, David B. Menkes

Prevention of persistent pain with lidocaine infusions in breast cancer surgery (PLAN): study protocol for a multicenter randomized controlled trial

James S. Khan, Ian Gilron, P. J. Devereaux, Hance Clarke, Nour Ayach, George Tomlinson, May Lynn Quan, Karim S. Ladha, Stephen Choi, Allana Munro, Richard Brull, David W. Lim, Sinziana Avramescu, Philippe Richebé, Nicole Hodgson, James Paul, Daniel I. McIsaac, Simone Derzi, Geoff L. Zbitnew, Alexandra M. Easson, Naveed T. Siddiqui, Sarah J. Miles, Keyvan Karkouti, Elena Parvez, Nicole J. Look Hong, Frances C. Wright, Amanda Roberts, Jaime Escallon, Gary Ko, Alexander Huang, Fabricio B. Zasso, Wey L. Leong, Andrea M. Covelli, Howard Meng, Ana Sjaus, Tina Kerelska, Vishal Uppal, Yehoshua Gleicher, Anne O’Neill, Li Wang, Daniel Sellers, Maria B. C. Chuquer, Geoffrey S. Hawboldt, Stefan O. P. Hofer, Harsha Shanthanna, Lucy K. Helyer, Bilal M. Ansari, Salima S. J. Ladak, Inna Oyberman, Erin Cordeiro, Carlos A. Ibarra Moreno, Elad Dana, Jason W. Busse, D Norman Buckley, Siba Haykal, Stuart A. McCluskey, Dolores McKeen, Julian Wiegelmann, Geoffrey Warden, Kathryn A. Sparrow, Mandeep Singh, Rachael Bosma, David Flamer, Richard L. Mah, Derek Diliane, Antoine Bouchard-Fortier, Alison Laws, Ashley Drohan

  • Open Access
  • Study protocol

The impact of elder abuse training on subacute health providers and older adults: study protocol for a randomized control trial

Marina G. Cavuoto, Simona Markusevska, Catriona Stevens, Patricia Reyes, Gianna Renshaw, Micah D. J. Peters, Briony Dow, Peter Feldman, Andrew Gilbert, Elizabeth Manias, Duncan Mortimer, Joanne Enticott, Claudia Cooper, Josefine Antoniades, Brenda Appleton, Sigrid Nakrem, Meghan O’Brien, Joan Ostaszkiewicz, Marion Eckert, Cheryl Durston, Bianca Brijnath

  • Open Access
  • Methodology

Patient information leaflets for placebo-controlled surgical trials: a review of current practice and recommendations for developers

S. Cousins, M. Huttman, N. Blencowe, C. Tsang, D. Elliott, J. Blazeby, D. J. Beard, M. K. Campbell, K. Gillies

  • Open Access
  • Study protocol

Virtual reality as a method of cognitive training of processing speed, working memory, and sustained attention in persons with acquired brain injury: a protocol for a randomized controlled trial

T. Johansen, M. Matre, M. Løvstad, A. Lund, A. C. Martinsen, A. Olsen, F. Becker, C. Brunborg, J. Ponsford, J. Spikman, D. Neumann, S. Tornås

  • Open Access
  • Study protocol

START NOW WebApp—promoting emotion regulation and resilience in residential youth care and correctional institutions: study protocol for a cluster randomized controlled trial

Linda Kersten, Janine Alfano, Tobias E. Erlanger, Fabrice Helfenstein, Lelia Lanz, Stefan Weiss, Chiara Chilla, Beryll von Planta, Madlaina Kapoor, Nathalie Borel, Tabea Rocco, Andreas Papageorgiou, Catarina Fernandes De Brito, Arzie Bajrami, Valentine Savary, Melanie Mayor, Jana Hurschler, Alex Traut, Donja Brunner, Noortje Vriends, Christina Stadler

  • Open Access
  • Study protocol

Study protocol: group-based psychoeducation for relatives of patients with bipolar disorder—a large scale real-world randomized controlled parallel group trial, the R-bipolar RCT

Julie Ravneberg Stokholm, Maj Vinberg, Maria Faurholt-Jepsen, Lars Vedel Kessing

The effectiveness of relugolix compared with leuprorelin for preoperative therapy before laparoscopic myomectomy in premenopausal women, diagnosed with uterine fibroids: protocol for a randomized controlled study (MyLacR study)

Mari Kitade, Jun Kumakiri, Hiroyuki Kobori, Keisuke Murakami

  • Open Access
  • Study protocol

Implementation of supplemental physiotherapy following hip fracture surgery: a protocol for the process evaluation of a randomised controlled trial

Eleanor Raper, Lara A. Kimmel, Angela T. Burge, Ian A. Harris, Ilana N. Ackerman, Richard S. Page, Justine M. Naylor, Graham Hepworth, Belinda Gabbe, Christina L. Ekegren, Anthony Harris, Maame Esi Woode, Anne E. Holland

Efficacy of heel lifts for mid-portion Achilles tendinopathy (the LIFT trial): study protocol for a randomised controlled trial

Jaryd Bourke, Shannon Munteanu, Alessandro Garofolini, Simon Taylor, Peter Malliaras

  • Open Access
  • Study protocol

Nasal profile changes after LeFort I osteotomy (maxillary advancement) with and without ANS reduction in class III skeletal patients: a study protocol for a randomized clinical trial

Mehdi Sezavar, Hossein Rastegar Moghaddamshaldoozi, Afshin Haraji, Nima Ghanipour, Salar Chaychi Salmasi

Educational telerehabilitation program for women with pelvic floor dysfunctions after gynecological pelvic cancer treatment: protocol study for a randomized and controlled clinical trial

Tatiana de Bem Fretta, Gabriela Dassie Dacanal, Pauliana Carolina de Souza Mendes, Mirella Dias, Cristine Homsi Jorge

  • Open Access
  • Study protocol

Efficacy of endometrial receptivity testing for recurrent implantation failure in patients with euploid embryo transfers: study protocol for a randomized controlled trial

Yao Lu, Xinyi Mao, Yaqiong He, Yuan Wang, Yun Sun

Seizure control via pH manipulation: a phase II double-blind randomised controlled trial of inhaled carbogen as adjunctive treatment of paediatric convulsive status epilepticus (Carbogen for Status Epilepticus in Children Trial (CRESCENT))

Rob Forsyth, Maria Allen, Emma Bedson, Alice Downes, Chris Gough, Stuart Hartshorn, Kelly Lawton, Mark D. Lyttle, Shrouk Messahel, Niall Mullen, Joseph Raper, Anna Rosala-Harris, Leigh Taggart, Jason Urron, Emily Walton, Carrol Gamble, Meriel Tolhurst-Cleaver, Sarah Siner, Anandi Singh, Elizabeth Ledger, Thomas Harris, Rachel Amos, Alice J. Downes, Sally Price, Maria Mikhail, Noor Alhashimi

  • Open Access
  • Correction

Correction: Medicinal Cannabis (MedCan 3): a randomised, multicentre, double-blind, placebo-controlled trial to assess THC/CBD (1:20) to relieve symptom burden in patients with cancer—a study protocol for a randomised controlled trial

Taylan Gurgenci, Janet Hardy, Georgie Huggett, Karyn Foster, Anita Pelecanos, Ristan Greer, Jennifer Philip, Alison Haywood, Ruwani Mendis, Patsy Yates, Phillip Good

Effect of 12-week head-down strong abdominal breathing on cognitive function in patients with stable chronic obstructive pulmonary disease: a single-centre randomised controlled trial protocol

Feiyun Song, Kexin Ding, Mingyun Sun, Rui Xia

Intermittent blood flow restriction with low-load resistance training for older adults with knee osteoarthritis: a randomized, controlled, non-inferiority trial protocol

Qiao-Mei Hong, Hao-Nan Wang, Xi-Hui Liu, Wen-Qi Zhou, Xiao-Bing Luo

  • Open Access
  • Methodology

Survival analysis for AdVerse events with VarYing follow-up times (SAVVY): summary of findings and assessment of existing guidelines

Kaspar Rufibach, Jan Beyersmann, Tim Friede, Claudia Schmoor, Regina Stegherr

Physical rehabilitation program for cardiorespiratory health and quality of life among breast cancer survivors in UAE: protocol for a randomized control trial

Fatima Abdul Rashid, Wajiha Anwar, Praveen Kumar Kandakurti, Animesh Hazari

Effects of robot-assisted upper limb training combined with functional electrical stimulation in stroke patients: study protocol for a randomized controlled trial

Xu Yang, Wang Fengyi, Chen Yi, Qiu Lin, Lin Yang, Li Xize, Liu Shaxin, Yang Yonghong

Blood flow restriction Exercise in the perioperative setting to Prevent loss of muscle mass in patients with pancreatic, biliary tract, and liver cancer: study protocol for the PREV-Ex randomized controlled trial

Poorna Anandavadivelan, Daniele Cardinale, Rune Blomhoff, Berit Sunde, Kristoffer Lassen, Dyre Kleive, Christian Sturesson, Stefan Gilg, Truls Raastad, Sara Mijwel

Effect of early vs. delayed extubation on functional outcome among patients with acute ischemic stroke treated with endovascular thrombectomy under general anesthesia: the prospective, randomized controlled EDESTROKE trial study protocol

Manuel Taboada, Ana Estany-Gestal, Jorge Fernández, Laura Barreiro, Kora Williams, Manuel Rodríguez-Yáñez, Pablo Otero, Alberto Naveira, Valentín Caruezo, Sonia Veiras, Eva San Luis, Laura Dos Santos, María Diaz-Vieito, Susana Arias-Rivas, María Santamaría-Cadavid, Emilio Rodríguez-Castro, Fernando Vázquez, Miguel Blanco, Antonio Mosquera, Jose Antonio Castiñeiras, Ignacio Muniategui, Esteban Ferreiroa, Agustín Cariñena, Ana Tubio, Olga Campaña, Salomé Selas, Francisco Aneiros, Adrián Martínez, María Eiras, Jose Costa, Jose María Prieto, Julián Álvarez

Assessing the Impact of an Artificial Intelligence-Based Model for Intracranial Aneurysm Detection in CT Angiography on Patient Diagnosis and Outcomes (IDEAL Study)—a protocol for a multicenter, double-blinded randomized controlled trial

Zhao Shi, Bin Hu, Mengjie Lu, Zijian Chen, Manting Zhang, Yizhou Yu, Changsheng Zhou, Jian Zhong, Bingqian Wu, Xueming Zhang, Yongyue Wei, Long Jiang Zhang

Understanding the processes underpinning IMPlementing IMProved Asthma self-management as RouTine (IMP2ART) in primary care: study protocol for a process evaluation within a cluster randomised controlled implementation trial

J. Sheringham, L. Steed, K. McClatchey, B. Delaney, A. Barat, V. Hammersley, V. Marsh, N. J. Fulop, S. J. C. Taylor, H. Pinnock

  • Open Access
  • Study protocol

Gender-transformative school-based sexual health intervention: study protocol for a randomized controlled trial

Loreto Leiva, Betzabé Torres-Cortés, Andrés Antivilo-Bruna, Gloria Zavala-Villalón

Effectiveness of exercise rehabilitation on aplastic anemia patients receiving hematopoietic stem cell transplantation: study protocol for a randomized controlled trial

Menghua Ye, Ting Liu, Xiaopei Mao, Xiaoxue Tan, Jin Wang, Min Xu

Effect of desflurane anesthesia on flash visual evoked potential monitoring in patients undergoing spine surgery: study protocol for a randomized controlled trial

Jiajia Ma, Jing Wang, Yun Li, Yuxuan Fu, Yang Li, Hui Qiao, Ruquan Han

  • Open Access
  • Study protocol

Enhancing patient-clinician collaboration during treatment decision-making: study protocol for a community-engaged, mixed method hybrid type 1 trial of collaborative decision skills training (CDST) for veterans with psychosis

Emily B. H. Treichler, Lauren E. McBride, Elissa Gomez, Joanna Jain, Sydney Seaton, Kasey E. Yu, David Oakes, Dimitri Perivoliotis, Vanessa Girard, Samantha Reznik, Michelle P. Salyers, Michael L. Thomas, William D. Spaulding, Eric L. Granholm, Borsika A. Rabin, Gregory A. Light

Letrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: study protocol for a randomized controlled trial

Yanqiu Xie, Min Deng, Weifen Deng, Qi Fan, Yuhua Shi

Community-based management of arterial hypertension and cardiovascular risk factors by lay village health workers for people with controlled and uncontrolled blood pressure in rural Lesotho: joint protocol for two cluster-randomized trials within the ComBaCaL cohort study (ComBaCaL aHT Twic 1 and ComBaCaL aHT TwiC 2)

Felix Gerber, Ravi Gupta, Thabo Ishmael Lejone, Thesar Tahirsylaj, Tristan Lee, Giuliana Sanchez-Samaniego, Maurus Kohler, Maria-Inés Haldemann, Fabian Raeber, Mamakhala Chitja, Malebona Mathulise, Thuso Kabi, Mosoetsi Mokaeane, Malehloa Maphenchane, Manthabiseng Molulela, Makhebe Khomolishoele, Mota Mota, Sesale Masike, Matumaole Bane, Mamoronts’ane Pauline Sematle, Retselisitsoe Makabateng, Madavida Mphunyane, Sejojo Phaaroe, Dave Brian Basler, Kevin Kindler, Thilo Burkard, Matthias Briel, Frédérique Chammartin, Niklaus Daniel Labhardt, Alain Amstutz

Lomustine with or without reirradiation for first progression of glioblastoma, LEGATO, EORTC-2227-BTG: study protocol for a randomized phase III study

Matthias Preusser, Tomáš Kazda, Emilie Le Rhun, Felix Sahm, Marion Smits, Jens Gempt, Johan AF Koekkoek, Angelo F Monti, Marcell Csanadi, János György Pitter, Helen Bulbek, Beatrice Fournier, Caroline Quoilin, Thierry Gorlia, Michael Weller, Giuseppe Minniti

The effect of pre-emptive oral pregabalin on opioid consumption in patients undergoing laparoscopic sleeve gastrectomy with an analysis of intraoperative hemodynamic stability and quality of recovery: study protocol for a randomized, prospective, double-blind study

Piotr Mieszczanski, Grzegorz Gorniewski, Marek Janiak, Janusz Trzebicki

Minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): study protocol for a multicentre, stepped-wedge, cluster-randomised controlled trial

D. Stelzer, H. Binder, M. Glattacker, E. Graf, M. Hahn, M. Hollenbeck, K. Kaier, B. Kowall, N. Kuklik, G. Metzner, N. Mueller, L. Seiler, S. Stolpe, C. Blume

A randomised controlled trial of the Learning Skills Together (LST) intervention to improve dementia family caregivers’ self-efficacy with complex care

Kylie Meyer, Kyungmi Lee, Sutthinee Thorngthip, Patricia Burant, Megan Lippe, Daria Neidre, Carole White, Rocio Norman, Byeong Yeob Choi, Crystal M. Glover, Janice Bell, Kenneth Hepburn

Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial

Aljoscha Rastan, Tanja Böhme, Thomas Zeller

Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well)

F. Benz, L. Grolig, S. Hannibal, C. Buntrock, P. Cuijpers, K. Domschke, D. D. Ebert, J. Ell, M. Janneck, C. Jenkner, A. F. Johann, A. Josef, M. Kaufmann, A. Koß, T. Mallwitz, H. Mergan, C. M. Morin, D. Riemann, H. Riper, S. R. Schmid, F. Smit, L. Spille, L. Steinmetz, E. J. W. Van Someren, K. Spiegelhalder, D. Lehr

  • Open Access
  • Research

Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol: an analysis of adult participant information leaflets and their corresponding protocols

Ellen Murphy, Katie Gillies, Frances Shiely

  • Open Access
  • Study protocol

Surgical Handover Core Outcome Measures (SH-CORE): a protocol for the development of a core outcome set for trials in surgical handover

Jessica M. Ryan, Declan Devane, Anastasija Simiceva, Walter Eppich, Dara O. Kavanagh, Christine Cullen, Aisling M. Hogan, Deborah A. McNamara

Effect of essential phospholipids on hepatic steatosis in metabolic dysfunction-associated steatotic liver disease associated with type 2 diabetes mellitus and/or hyperlipidemia and/or obesity: study protocol of a randomized, double-blind, phase IV clinical trial

Norbert Stefan, Marek Hartleb, Branko Popovic, Rafael Varona

  • Open Access
  • Review

Registry-based randomised controlled trials: conduct, advantages and challenges—a systematic review

Frances Shiely, Niamh O Shea, Ellen Murphy, Joseph Eustace

The effect of an improved ICU physical environment on outcomes and post-ICU recovery—a protocol

Oystein Tronstad, Barbara Zangerl, Sue Patterson, Dylan Flaws, Stephanie Yerkovich, Irene Szollosi, Nicole White, Veronica Garcia-Hansen, Francisca Rodriguez Leonard, Benjamin D. Weger, Frédéric Gachon, David Brain, Jayshree Lavana, Carol Hodgson, John F. Fraser

Early Hydrogen–Oxygen Gas Mixture Inhalation in Patients with Aneurysmal Subarachnoid Hemorrhage (HOMA): study protocol for a randomized controlled trial

Fa Lin, Runting Li, Yu Chen, Jun Yang, Ke Wang, Yitong Jia, Heze Han, Qiang Hao, Guangzhi Shi, Shuo Wang, Yuanli Zhao, Xiaolin Chen

Colchicine to reduce coronavirus disease-19-related inflammation and cardiovascular complications in high-risk patients post-acute infection with SARS-COV-2—a study protocol for a randomized controlled trial

Shani S. Thankachen, Niveditha Devasenapathy, Abhinav Bassi, Arpita Ghosh, Sumaiya Arfin, Balaji Gummidi, Aneesh Basheer, Ashfak Bangi, Dibakar Sahu, Ashish Bhalla, Merlin Blesson, Manish Jain, Vivekanand Jha

  • Open Access
  • Study protocol

Generalized music therapy to reduce neuroactive drug needs in critically ill patients. Study protocol for a randomized trial

Giovanni Mistraletti, Anna Solinas, Silvia Del Negro, Carlotta Moreschi, Stefano Terzoni, Paolo Ferrara, Katerina Negri, Davide Calabretta, Paolo Formenti, Angelo Formenti, Michele Umbrello

The effect of different flushing and locking techniques on catheter occlusion rates in central venous catheters: protocol for a multicentre, randomized controlled, parallel-group, open-label, superiority clinical trial

Rongmei Li, Mian Zhou, Lulu Sun, Lili Sha, Biyun Xu, Taishun Li, Tingting Tao, Ling Yuan

Study protocol for a single-blind, parallel-group, randomized, controlled superiority trial of intensive versus weekly delivered prolonged exposure for adults with post-traumatic stress disorder

Maria Bragesjö, Brooke Fina, Ekaterina Ivanova, Volen Z Ivanov, Christian Rück

  • Open Access
  • Research

Consultations about randomised controlled trials are shorter and less in-depth for socioeconomically disadvantaged patients compared to socioeconomically advantaged patients: qualitative analysis across three trials

Mariana Popa, Bridget Young, Nikki Rousseau, Mary G. Cherry, Isobel Jenkins, Jane Cloke, Andrew Pettitt, Michael D. Jenkinson, Saiqa Ahmed, Allan R. Pemberton, Frances C. Sherratt

Statistical analysis plan for the TRANSLATE (TRANSrectal biopsy versus Local Anaesthetic Transperineal biopsy Evaluation of potentially clinically significant prostate cancer) multicentre randomised controlled trial

Ioana R. Marian, Alexander Ooms, Jane Holmes, Matthew J. Parkes, Alastair D. Lamb, Richard J. Bryant

  • Open Access
  • Research

Effectiveness of remote risk-based monitoring and potential benefits for combination with direct data capture

Osamu Yamada, Shih-Wei Chiu, Toru Nakazawa, Satoru Tsuda, Mitsuhide Yoshida, Toshifumi Asano, Taiki Kokubun, Kazuki Hashimoto, Munenori Takata, Suzuka Ikeda, Yosuke Kawabe, Yuko Tamura, Takuhiro Yamaguchi

Effects of Pycnogenol® in people with post-COVID-19 condition (PYCNOVID): study protocol for a single-center, placebo controlled, quadruple-blind, randomized trial

Thomas Radtke, Lisa Künzi, Julia Kopp, Manuela Rasi, Julia Braun, Kyra D. Zens, Babette Winter, Alexia Anagnostopoulos, Milo A. Puhan, Jan S. Fehr

Defatting of donor transplant livers during normothermic perfusion—a randomised clinical trial: study protocol for the DeFat study

Syed Hussain Abbas, Carlo D. L. Ceresa, Leanne Hodson, David Nasralla, Christopher J. E. Watson, Hynek Mergental, Constantin Coussios, Fotini Kaloyirou, Kerrie Brusby, Ana Mora, Helen Thomas, Daphne Kounali, Katie Keen, Joerg-Matthias Pollok, Rohit Gaurav, Satheesh Iype, Wayel Jassem, M. Thamara PR Perera, Abdul Rahman Hakeem, Simon Knight, Peter J. Friend

Financial incentives to motivate treatment for hepatitis C with direct acting antivirals among Australian adults (The Methodical evaluation and Optimisation of Targeted IncentiVes for Accessing Treatment of Early-stage hepatitis C: MOTIVATE-C): protocol for a dose-response randomised controlled study

Parveen Fathima, Mark Jones, Reena D’Souza, James Totterdell, Nada Andric, Penelope Abbott, Richard Norman, Kirsten Howard, Wendy Cheng, Alisa Pedrana, Joseph S. Doyle, Jane Davies, Thomas Snelling

SCANPatient: study protocol for a multi-centre, batched, stepped wedge, comparative effectiveness, randomised clinical trial of synoptic reporting of computerised tomography (CT) scans assessing cancers of the pancreas

Lin Li, Jessica Kasza, Ariadna Recasens, Liane Ioannou, Elysia Greenhill, Neil Merrett, David Cavallucci, Samantha Ellis, Helen Madgwick, Hyun Soo Ko, Lorraine Chantrill, Benjamin Loveday, Mehrdad Nikfarjam, Daniel Croagh, Jessica Yang, Andrew Dwyer, John Zalcberg, Charles Pilgrim

Correction: Study protocol for pragmatic trials of Internet-delivered guided and unguided cognitive behavior therapy for treating depression and anxiety in university students of two Latin American countries: the Yo Puedo Sentirme Bien study

Corina Benjet, Ronald C. Kessler, Alan E. Kazdin, Pim Cuijpers, Yesica Albor, Nayib Carrasco Tapias, Carlos C. Contreras-Ibáñez, Ma Socorro Durán González, Sarah M. Gildea, Noé González, José Benjamín Guerrero López, Alex Luedtke, Maria Elena Medina-Mora, Jorge Palacios, Derek Richards, Alicia Salamanca-Sanabria, Nancy A. Sampson

  • Open Access
  • Methodology

Accounting for center-level effects in multicenter randomized controlled trials

Shofiqul Islam, Shrikant I. Bangdiwala

  • Open Access
  • Research

Trial participants’ self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and luck

Frances Shiely, Ellen Murphy, Katie Gilles, Kerry Hood, Lydia O’Sullivan, Nicola Harman, Talia Isaacs, Shaun Treweek

The effect of an online acceptance and commitment intervention on the meaning-making process in cancer patients following hematopoietic cell transplantation: study protocol for a randomized controlled trial enhanced with single-case experimental design

Aleksandra Kroemeke, Joanna Dudek, Marta Kijowska, Ray Owen, Małgorzata Sobczyk-Kruszelnicka

  • Open Access
  • Study protocol

A counselling intervention for individual strategies to prevent complications and strengthen resources during pregnancy in gynaecological care (AOK-Family +): study protocol for a cluster-randomised controlled trial

Mareike Krämer, Laura Wohlhüter, Lina Hermeling, Jan Koetsenruijter, Martina Kamradt, Michel Wensing, Manuela Bombana

Enhancing HIV pre-exposure prophylaxis outcomes among Kenyan adolescent girls and young women with a novel pharmacy-based PrEP delivery platform: protocol for a cluster-randomized controlled trial

Harison K. Lagat, Jillian Pintye, Elizabeth Harrington, Samantha Houck, Zachary Kwena, Meena Lenn, Felix Mogaka, Vincent Momanyi, Melissa Mugambi, Bernard Nyerere, Josephine Odoyo, Victor Omollo, Katrina F. Ortblad, Greshon Rota, Monisha Sharma, Elizabeth A. Bukusi

  • Open Access
  • Study protocol

Early parent-child intervention with Dialogic Book-Sharing: effects on child communicative and socio-emotional development and on parenting. Study protocol for a multicentre randomised controlled trial in Italy

Cena Loredana, Trainini Alice, Murray Lynne, Cooper Peter, Calza Stefano, Belluardo Mauro

Effectiveness of repetitive transcranial magnetic stimulation for insomnia disorder on fear memory extinction: study protocol for a randomised controlled trial

Jingjing Sun, Bidan Zhang, Wenyue Xu, Panpan Li, Danwei Zhang, Bei Zhao, Zhoubing Wang, Bin Wang

Transcutaneous auricular vagus nerve stimulation to acutely reduce emotional vulnerability and improve emotional regulation in borderline personality disorder (tVNS-BPD): study protocol for a randomized, single-blind, sham-controlled trial

Giuseppe Guerriero, Sophie I. Liljedahl, Hanne K. Carlsen, Marta López Muñoz, Alexander R. Daros, Anthony C. Ruocco, Steinn Steingrimsson

  • Open Access
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Needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren’s contractures of the fingers (Hand-2): study protocol for a randomised controlled trial

Samantha Harrison, Reuben Ogollah, William Hollingworth, Nicola Mills, Alexia Karantana, Jane Blazeby, Alan Montgomery, Aisha Shafayat, Hugh Jarrett, Tim Davis

Evaluation of “Cognitive Behavioral Intervention for Trauma in Schools” (CBITS) in child welfare programs in Germany: study protocol of a randomized controlled trial

Elisa Pfeiffer, Loni Dörrie, Jessica Köksal, Fabienne Krech, Rainer Muche, Jacob Segler, Cedric Sachser

  • Open Access
  • Update

Update to: Assessing the efficacy of male Wolbachia-infected mosquito deployments to reduce dengue incidence in Singapore

Jue Tao Lim, Diyar Mailepessov, Chee-Seng Chong, Chia-Chen Chang, Borame Dickens, Yee Ling Lai, Lu Deng, Caleb Lee, Li Yun Tan, Grace Chain, Soon Hoe Ho, Muhammad Faizal Zulkifli, Jonathan Liew, Kathryn Vasquez, Vernon Lee, Judith Chui Ching Wong, Shuzhen Sim, Cheong Huat Tan, Lee Ching Ng

Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design

L. A. Daamen, I. W. J. M. van Goor, V. P. Groot, P. C. M. Andel, L. A. A. Brosens, O. R. Busch, G. A. Cirkel, N. Haj Mohammad, H. D. Heerkens, I. H. J. T. de Hingh, F. Hoogwater, H. W. M. van Laarhoven, M. Los, G. J. Meijer, V. E. de Meijer, R. Pande, K. J. Roberts, J. Stoker, M. W. J. Stommel, G. van Tienhoven, R. C. Verdonk, H. M. Verkooijen, F. J. Wessels, J. W. Wilmink, M. G. Besselink, H. C. van Santvoort, M. P. W. Intven, I. Q. Molenaar

  • Open Access
  • Correction

Correction: Postoperative controls of ventilation tubes in children by general practitioner or otolaryngologist? Study protocol for a multicenter randomized non-inferiority study (The ConVenTu study)

Bjarne Austad, Ann Helen Nilsen, Anne-Sofie Helvik, Grethe Albrektsen, Ståle Nordgård, Wenche Moe Thorstensen

  • Open Access
  • Commentary

Studying harms of interventions with an equity lens in randomized trials

Tianjing Li, Evan Mayo-Wilson, Daniel Shaughnessy, Riaz Qureshi

  • Open Access
  • Gout
  • Study protocol

The effect of exercise rehabilitation with exergames combined with ice therapy in the treatment of obese patients with gout: protocol for a clinical trial

Manting Cao, Hazwani Ahmad Yusof, Jianer Chen, Mohd Faizal Jalil, Siti Khairizan Rahim, Mohamad Zulfadhli Abdullah

Disagreements in risk of bias assessment for randomized controlled trials in hypertension-related Cochrane reviews

Yi Yao, Jing Shen, Jianzhao Luo, Nian Li, Xiaoyang Liao, Yonggang Zhang

The effectiveness of multidisciplinary interventions based on health belief model on musculoskeletal pain in the elderly living in nursing homes: a study protocol for a randomized controlled trial

Sogand Habibi, Sedigheh Sadat Tavafian, Reza Maghbouli, Ali Montazeri

  • Open Access
  • Correction

Correction: Palliative care for persons with late-stage Alzheimer’s and related dementias and their caregivers: protocol for a randomized clinical trial

M. Toles, C. Kistler, F. C. Lin, M. Lynch, K. Wessell, S. L. Mitchell, L. C. Hanson

A phase 3 randomised double-blind placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine use disorder: a study protocol for the Tina Trial

Rebecca McKetin, Tayla J. Degan, Lucy Saunders, Long Nguyen, Gregory Dore, Steven Shoptaw, Michael Farrell, Louisa Degenhardt, Peter J. Kelly, Alyna Turner, Philip J. Clare, Olivia M. Dean, Shalini Arunogiri, Samantha Colledge-Frisby, Juanita Koeijers, David Goodman-Meza, Barbara Sinclair, David Reid, Harry Hill, Jeremy Hayllar, Michael Christmass, Frank Cordaro, Robert Lundin, Willy Liaw, Danica Liu, Ellie Holyoak, Brian Tid-Fung Wu, Joel Keygan, Ava Kontogiannis, Lily Palmer, Caity Morrison, Anna Wrobel, Bec Hyland, Marianne Byrne, Samantha Russell, Emma Zahra, Michael Berk

A proposal for using benefit-risk methods to improve the prominence of adverse event results when reporting trials

Nikki Totton, Ed Waddingham, Ruth Owen, Steven Julious, Dyfrig Hughes, Jonathan Cook

Correction: TRansfusion strategies in Acute brain INjured patients (TRAIN): a prospective multicenter randomized interventional trial protocol

Fabio Silvio Taccone, Rafael Badenes, Carla Bittencourt Rynkowski, Pierre Bouzat, Anselmo Caricato, Pedro Kurtz, Kirsten Moller, Manuel Quintana Diaz, Mathieu Van Der Jagt, Walter Videtta, Jean-Louis Vincent

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An exercise and patient education intervention to reduce pain and physical limitations in adults with acetabular dysplasia: study protocol for a process evaluation integrated within a randomised controlled trial (the MovetheHip trial)

Julie S. Jacobsen, Rhiannon Evans, Kelly Morgan, Kristian Thorborg, Lisa G. Oestergaard, Dorthe Sørensen

Effectiveness of a positive psychology and mindfulness-based app on mental health for parents of children with a neurodevelopmental disorder: study protocol of a pragmatic international randomized controlled trial

Kim J. M. Tönis, Constance H. C. Drossaert, Peter M. ten Klooster, Marie Schaer, Thomas Bourgeron, Jan K. Buitelaar, Yair Sadaka, Christine M. Freitag, Keren Mayer Lapidus, Andreas G. Chiocchetti, Wouter G. Staal, Ernst T. Bohlmeijer

Effects of whole-body vibration on body composition, microbiota, cardiometabolic markers, physical fitness, and quality of life after bariatric surgery: protocol for a randomized controlled trial

Alejandro Gómez-Bruton, Pilar Irún, Angel Matute-Llorente, Gabriel Lozano-Berges, Ana Moradell, Susana Ara-Gimeno, Jorge Subias-Perie, Marta Sánchez-Luengo, Gonzalo Hijos-Mallada, Sandra García-Mateo, Samantha Arechavaleta, María José Palacios Fanlo, Angel Lanas, Jose A. Casajús

Volatile vs Total intravenous Anaesthesia for major non-cardiac surgery: a pragmatic randomised triaL (VITAL)

Joyce Yeung, Shaman Jhanji, John Braun, Janet Dunn, Lucy Eggleston, Samuel Frempong, Louise Hiller, Claire Jacques, Monica Jefford, James Mason, Ramani Moonesinghe, Rupert Pearse, Benjamin Shelley, Cecilia Vindrola

  • Open Access
  • Research

Strengths, challenges, and strategies for implementing pragmatic multicenter randomized controlled trials (RCTs): example of the Personalized Citizen Assistance for Social Participation (APIC) trial

Mélanie Levasseur, Agathe Chaintré-Prieur, Marie-France Dubois, Catherine Maisonneuve, Johanne Filiatrault, Helen-Maria Vassiliadis

  • Open Access
  • Correction

Correction: PReventing and Approaching Crises for frail community-dwelling patients Through Innovative Care (PRACTIC): protocol for an effectiveness cluster randomised controlled trial

Anette Væringstad, Ellen Thea Gjelseth Dalbak, Daniela Holle, Janne Myhre, Øyvind Kirkevold, Sverre Bergh, Bjørn Lichtwarck

Study on the efficiency of virtual reality in the treatment of alcohol use disorder: study protocol for a randomized controlled trial

Fanny Nègre, Maud Lemercier-Dugarin, Romain Gomet, Antoine Pelissolo, Eric Malbos, Lucia Romo, El-Hadi Zerdazi

Effect of ultrasound-guided injection of botulinum toxin type A into shoulder joint cavity on shoulder pain in poststroke patients: study protocol for a randomized controlled trial

Peng Zheng, Yu Shi, Hang Qu, Meng lin Han, Zhi qiang Wang, Qing Zeng, Manxu Zheng, Tao Fan

  • Open Access
  • Study protocol

Mental health literacy and academic performance (MHLAP) in high school students: a randomized clinical trial protocol

Cezar Giosan, Alexandru Pană, Ana Cosmoiu, Ana-Maria Chira, Ana-Maria Toma, Claudiu-Cristian Papasteri, Cătălin Nedelcea, Cătălina Popoviciu

Is casting of displaced paediatric distal forearm fractures non-inferior to reduction under general anaesthesia? Study protocol for a pragmatic, randomized, controlled non-inferiority multicentre trial (the casting trial)

Katrine Rønn Abildgaard, Peter Buxbom, Ole Rahbek, Martin Gottliebsen, Per Hviid Gundtoft, Bjarke Viberg, Stig Brorson

Virtual reality cue-exposure therapy in reducing cocaine craving: the Promoting Innovative COgnitive behavioral therapy for Cocaine use disorder (PICOC) study protocol for a randomized controlled trial

T. Lehoux, Antonio Capobianco, Jérôme Lacoste, Sloane Rollier, Yann Mopsus, Manuela Melgire, Flavien Lecuyer, Miguel Gervilla, Luisa Weiner

Evaluating the effectiveness of early urethral catheter removal combined with intermittent catheterization for promoting early recovery of bladder function after laparoscopic radical hysterectomy: a study protocol for a randomized controlled trial

Yanli Chen, Ling Li, Yuanxiang Shi, Xin Rong, Yan Wang, Jiaojiao Wu, Xiaolong Liang, Zhimin Wu

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Randomized controlled trial of enteral vitamin D supplementation (ViDES) in infants <28 weeks gestational age or <1000 g birth weight: study protocol

Mar Romero-Lopez, Jon E. Tyson, Mamta Naik, Claudia Pedroza, Lindsay F. Holzapfel, Elenir Avritscher, Ricardo Mosquera, Amir Khan, Matthew Rysavy

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Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial)

Mariana Murea, Jochen G. Raimann, Jasmin Divers, Harvey Maute, Cassandra Kovach, Emaad M. Abdel-Rahman, Alaa S. Awad, Jennifer E. Flythe, Samir C. Gautam, Vandana D. Niyyar, Glenda V. Roberts, Nichole M. Jefferson, Islam Shahidul, Ucheoma Nwaozuru, Kristie L. Foley, Erica J. Trembath, Merlo L. Rosales, Alison J. Fletcher, Sheikh I. Hiba, Anne Huml, Daphne H. Knicely, Irtiza Hasan, Bhaktidevi Makadia, Raman Gaurav, Janice Lea, Paul T. Conway, John T. Daugirdas, Peter Kotanko, Denisse A. Funes, Jessica Guillaume, Victoria Shoyelu, Katherine Vergara, Lyn B. Lyman, Fatima Salmi, Erika Adams, Jessica Farrell, Nancy Ginsberg, Christa Howard, Suzanne Shabdue, Shawanna Jackson, Seth Johnson, Randall D. Blackie, Sheetal Chaudhuri, Priya Desai, Kristy Hamilton, Igor Shumilin, Diana Clynes, Valerie Gonzalez, Erin Kahle, Marie Mitchell, Jennifer Rate, Brindusa Burciu, Lilliana Serrano, Alexandra Peluso, Valeria G. Bittencourt, Zohreh Forghani, Elnaz R. Ghalechi, Allison Green, Marina Markovic, Debra Martin, Caroline Poulton, Simran Singh, Katlyn Stiles, Ashleigh Trapuzzano, Joni Baker, Susan Trynosky

  • Open Access
  • Study protocol

Impact of an intergenerational program to improve loneliness and social isolation in older adults initiated at the time of emergency department discharge: study protocol for a three-arm randomized clinical trial

David Zheng, Louise Rose, Bjug Borgundvaag, Shelley L. McLeod, Donald Melady, Rohit Mohindra, Samir Sinha, Virginia Wesson, Lesley Wiesenfeld, Sabrina Kolker, Alex Kiss, Judy A. Lowthian, Jacques S. Lee

Copenhagen Mesenteric stent study (COMESS)—a randomized trial of stent versus covered stent treatment for chronic mesenteric ischemia

Alexandra A. Brandtzäg, Jonas P. Eiberg, Lars Lönn, Mikkel Taudorf, Timothy A. Resch

Biomarker Driven Antifungal Stewardship (BioDriveAFS) in acute leukaemia—a multi-centre randomised controlled trial to assess clinical and cost effectiveness: a study protocol for a randomised controlled trial

Lydia Flett, Radwa Abdelatif, Sarah Akhtar Baz, Samantha Brady, Belén Corbacho, Kate Common, Abbie Cowling, Caroline Fairhurst, Ellie Fitzmaurice, Shreyans Gandhi, Andrea Hilton, William Hope, Alex Howard, Joanne Laycock, Patrick Lillie, Gemma Mitchell, Adwoa Parker, Mary Peel, Laura Sheard, Jacqueline Sneddon, Thomas Taynton, Puvan Tharmanathan, David Torgerson, Han-I Wang, David Allsup, Gavin Barlow

Cognitive training and promoting a healthy lifestyle for individuals with isolated REM sleep behavior disorder: study protocol of the delayed-start randomized controlled trial CogTrAiL-RBD

Anja Ophey, Sinah Röttgen, Julia Pauquet, Kim-Lara Weiß, Daniel Scharfenberg, Christopher E. J. Doppler, Aline Seger, Clint Hansen, Gereon R. Fink, Michael Sommerauer, Elke Kalbe

Clinical trial results in context: comparison of baseline characteristics and outcomes of 38,510 RECOVERY trial participants versus a reference population of 346,271 people hospitalised with COVID-19 in England

Guilherme Pessoa-Amorim, Raphael Goldacre, Charles Crichton, Will Stevens, Michelle Nunn, Andy King, Dave Murray, Richard Welsh, Heather Pinches, Andrew Rees, Eva J. A. Morris, Martin J. Landray, Richard Haynes, Peter Horby, Karl Wallendszus, Leon Peto, Mark Campbell, Charlie Harper, Marion Mafham

Traditional healer support to improve HIV viral suppression in rural Uganda (Omuyambi): study protocol for a cluster randomized hybrid effectiveness-implementation trial

Radhika Sundararajan, Misha Hooda, Yifan Lai, Denis Nansera, Carolyn Audet, Jennifer Downs, Myung Hee Lee, Margaret McNairy, Winnie Muyindike, Juliet Mwanga-Amumpaire

Effect of esketamine combined with dexmedetomidine on delirium in sedation for mechanically ventilated ICU patients: protocol for a nested substudy within a randomized controlled trial

Wenhui Zhang, Jinjin You, Jing Hu, Xiangding Chen, Han Wang, Nan Li, Chen Wei, Wanchun Tang, Xiangrong Zuo

Effect of norepinephrine and phenylephrine on prothrombotic response in patients undergoing cesarean section under spinal anesthesia: protocol for a randomized, double-blind, controlled study

Wenhui Tao, Yufang Xie, Wei Ding, Jinfeng Bao, Ye Zhang, Xianwen Hu

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  • Study protocol

Comparison of “IN-REC-SUR-E” and LISA in preterm neonates with respiratory distress syndrome: a randomized controlled trial (IN-REC-LISA trial)

Giovanni Vento, Angela Paladini, C. Aurilia, S. Alkan Ozdemir, V. P. Carnielli, F. Cools, S. Costa, F. Cota, C. Dani, P. G. Davis, S. Fattore, C. Fè, N. Finer, F. P. Fusco, C. Gizzi, E. Herting, M. Jian, A. Lio, G. Lista, F. Mosca, S. Nobile, A. Perri, S. Picone, J. J. Pillow, G. Polglase, T. Pasciuto, R. Pastorino, M. Tana, D. Tingay, C. Tirone, A. H. van Kaam, M. L. Ventura, A. Aceti, M. Agosti, G. Alighieri, G. Ancora, V. Angileri, G. Ausanio, S. Aversa, E. Balestri, E. Baraldi, M. C. Barbini, C. Barone, R. Beghini, C. Bellan, A. Berardi, I. Bernardo, P. Betta, M. Binotti, B. Bizzarri, G. Borgarello, S. Borgione, A. Borrelli, R. Bottino, G. Bracaglia, I. Bresesti, I. Burattini, C. Cacace, F. Calzolari, M. F. Campagnoli, L. Capasso, M. Capozza, M. G. Capretti, J. Caravetta, C. Carbonara, V. Cardilli, M. Carta, F. Castoldi, A. Castronovo, E. Cavalleri, F. Cavigioli, S. Cecchi, V. Chierici, C. Cimino, F. Cocca, C. Cocca, P. Cogo, M. Coma, V. Comito, V. Condò, C. Consigli, R. Conti, M. Corradi, G. Corsello, L. T. Corvaglia, A. Costa, A. Coscia, F. Cresi, F. Crispino, P. D’Amico, L. De Cosmo, C. De Maio, G. Del Campo, S. Di Credico, S. Di Fabio, P. Di Nicola, A. Di Paolo, S. Di Valerio, A. Distilo, V. Duca, A. Falcone, R. Falsaperla, V. A. Fasolato, V. Fatuzzo, F. Favini, M. P. Ferrarello, S. Ferrari, F. Fiori Nastro, C. A. Forcellini, A. Fracchiolla, A. Gabriele, F. Galdo, F. Gallini, A. Gangemi, G. Gargano, D. Gazzolo, M. P. Gentile, S. Ghirardello, F. Giardina, L. Giordano, E. Gitto, M. Giuffrè, L. Grappone, F. Grasso, I. Greco, A. Grison, R. Guglielmino, I. Guidotti, I. Guzzo, N. La Forgia, S. La Placa, G. La Torre, P. Lago, L. Lanciotti, A. Lavizzari, F. Leo, V. Leonardi, D. Lestingi, J. Li, P. Liberatore, D. Lodin, R. Lubrano, M. Lucente, S. Luciani, D. Luvarà, G. Maffei, A. Maggio, L. Maggio, K. Maiolo, L. Malaigia, G. Mangili, A. Manna, E. Maranella, A. Marciano, P. Marcozzi, M. Marletta, L. Marseglia, D. Martinelli, S. Martinelli, S. Massari, L. Massenzi, F. Matina, L. Mattia, G. Mescoli, I. V. Migliore, D. Minghetti, I. Mondello, S. Montano, G. Morandi, N. Mores, S. Morreale, I. Morselli, M. Motta, M. Napolitano, D. Nardo, A. Nicolardi, S. Nider, G. Nigro, M. Nuccio, L. Orfeo, C. Ottaviano, P. Paganin, S. Palamides, S. Palatta, P. Paolillo, M. G. Pappalardo, E. Pasta, L. Patti, G. Paviotti, R. Perniola, G. Perotti, S. Perrone, F. Petrillo, M. S. Piazza, A. Piccirillo, M. Pierro, E. Piga, G. A. Pingitore, S. Pisu, C. Pittini, F. Pontiggia, G. Pontrelli, A. Primavera, A. Proto, L. Quartulli, F. Raimondi, L. Ramenghi, M. Rapsomaniki, A. Ricotti, C. Rigotti, M. Rinaldi, F. M. Risso, E. Roma, E. Romanini, V. Romano, E. Rosati, V. Rosella, I. Rulli, V. Salvo, C. Sanfilippo, A. Sannia, A. Saporito, A. Sauna, E. Scapillati, F. Schettini, A. Scorrano, S. Semeria Mantelli, V. Sepporta, P. Sindico, A. Solinas, E. Sorrentino, E. Spaggiari, A. Staffler, M. Stella, D. Termini, G. Terrin, A. Testa, G. Tina, M. Tirantello, B. Tomasini, F. Tormena, L. Travan, D. Trevisanuto, G. Tuling, V. Tulino, L. Valenzano, S. Vedovato, S. Vendramin, P. E. Villani, S. Viola, V. Viola, G. Vitaliti, M. Vitaliti, P. Wanker, Y. Yang, S. Zanetta, E. Zannin

Short-term inhalation of xenon during anesthesia for prevention of postoperative delirium in elderly patients undergoing laparoscopic radical colectomy: study protocol for a randomized controlled clinical trial

Yi Cheng, Ying Gao, Gu-Yue Liu, Fu‑Shan Xue, Mu Jin

  • Open Access
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Prospective validation of a mobile health application for blood pressure management in patients with hypertensive disorders of pregnancy: study protocol for a randomized controlled trial

Ju-Seung Kwun, Jina Choi, Yeonyee E. Yoon, Hong-Mi Choi, Jee Yoon Park, Hyeon Ji Kim, Min Jung Lee, Bo Young Choi, Sooyoung Yoo, Jung-Won Suh

Effects of ultrasound-guided serratus plane block combined with general anesthesia on postoperative early quality of recovery and analgesia in patients undergoing transapical transcatheter aortic valve implantation surgery: study protocol for a randomized controlled trial

Cheng Xiao, Fang Chen, Lei Cao, Ming Yang, Yuting Tan, Guoyun Lin, Guiying Yang, Sheng Jing, Hong Li

Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA)

Jaideep C. Menon, Denny John, Aswathy Sreedevi, Chandrasekhar Janakiram, Akshaya R, Sumithra S, Aravind M S, Mathews Numpeli, Bipin Gopal, Renjini B A, Sajeev P K, Ravivarman Lakshmanasamy, Abhishek Kunwar

Comparison of D2 vs D3 lymph node dissection for RIght COloN cancer (RICON): study protocol for an international multicenter open-label randomized controlled trial

Vladimir Balaban, Mikhail Mutyk, Nikolay Bondarenko, Stanislav Zolotukhin, Oleg Sovpel, Igor Sovpel, Dmitriy Zykov, Igor Rublevskiy, Mikhail Klochkov, Alfredo Ponce Prado, Mingze He, Petr Tsarkov

  • Open Access
  • Research

Early vocational rehabilitation and psychological support for trauma patients to improve return to work (the ROWTATE trial): study protocol for an individually randomised controlled multicentre pragmatic trial

Denise Kendrick, Rebecca Lindley, Lauren Blackburn, Cristina Roadevin, Ellen Thompson, Isabel Andrews, Fahim Anwar, Adam Brooks, Edd Carlton, Robert Crouch, Florence Day, Steve Fallon, Amanda Farrin, Laura Graham, Karen Hoffman, Rebekah Howell, Jain Holmes, Marilyn James, Trevor Jones, Blerina Kellezi, Jade Kettlewell, Richard Morriss, Roshan das Nair, Davina Richardson, Matthew Smith, Stephen Timmons, Alexandra Wright-Hughes, Kathryn Radford

Biofeedback combined with percutaneous electrical pudendal nerve stimulation for the treatment of low anterior rectal resection syndrome: a study protocol for a randomized controlled trial

Gaoyang Cao, Xinjie Zhang, Fei Wang, Da Man, Lijie Wu, Xuchu Pan, Shan Chen

Engaging Mood Brain Circuits with Psilocybin (EMBRACE): a study protocol for a randomized, placebo-controlled and delayed-start, neuroimaging trial in depression

Joshua M. Poulin, Gregory E. Bigford, Krista L. Lanctôt, Peter Giacobbe, Ayal Schaffer, Mark Sinyor, Jennifer S. Rabin, Mario Masellis, Amit Singnurkar, Christopher B. Pople, Nir Lipsman, Muhammad I. Husain, Joshua D. Rosenblat, Xingshan Cao, Bradley J. MacIntosh, Sean M. Nestor

Multimodal therapeutic intervention program associated with photobiomodulation therapy for individuals with chronic nonspecific neck pain: protocol for a clinical trial

Aron Charles Barbosa da Silva, Gabriela Nascimento Santana, Inaê Silva Santos, Patrícia Gabrielle dos Santos, Adriano Rodrigues de Oliveira, Almir Vieria Dibai Filho, Cid André Fidelis de Paula Gomes

A holistic lifestyle mobile health intervention for the prevention of type 2 diabetes and common mental disorders in Asian women with a history of gestational diabetes: a randomised control trial with 3-year follow-up protocol

Alicia Salamanca-Sanabria, Seaw Jia Liew, Jacqueline Mair, Maria De Iorio, Young Doris Yee Ling, Mya Thway Tint, Yew Tong Wei, Karen Lim, Desmond Ong, Yu Chung Chooi, Vicky Tay, Johan Gunnar Eriksson

Effectiveness of a mobile application for independent computerized cognitive training in patients with mild cognitive impairment: study protocol for the NeNaE Study, a randomized controlled trial

Drin Ferizaj, Oskar Stamm, Luis Perotti, Eva Maria Martin, Anja Ophey, Sophia Rekers, Daniel Scharfenberg, Tobias Oelgeschläger, Katharina Barcatta, Sigrid Seiler, Johanna Funk, Charles Benoy, Carsten Finke, Elke Kalbe, Kathrin Finke, Anika Heimann-Steinert

The efficacy of simple oral nutritional supplements versus usual care in postoperative patients with gastric cancer: study protocol for a multicenter, open-label, parallel, randomized controlled trial

Kohei Ueno, Tatsuto Nishigori, Yukinari Tokoro, Akiyoshi Nakakura, Shigeru Tsunoda, Shigeo Hisamori, Kyoichi Hashimoto, Seiichiro Kanaya, Kenjiro Hirai, Eiji Tanaka, Hiroaki Hata, Dai Manaka, Masazumi Sakaguchi, Masato Kondo, Takatsugu Kan, Atsushi Itami, Akira Miki, Yuichiro Kawamura, Kosuke Toda, Hiroshi Okabe, Michihiro Yamamoto, Yoshito Yamashita, Yosuke Kinjo, Hironori Kawada, Kazutaka Obama

A hybrid digital parenting programme to prevent abuse of adolescents in Tanzania: statistical analysis plan for a pragmatic cluster randomised controlled trial

Jonathan Klapwijk, G. J. Melendez-Torres, Abigail Ornellas, Mwita Wambura, Angelique N. Chetty, Lauren Baerecke, Joyce Wamoyi, Lucie D. Cluver

The role of cytoreductive nephrectomy in metastatic renal cell carcinoma in immune-oncology era (SEVURO-CN): study protocol for a multi-center, prospective, randomized trial

Jee Soo Park, Jongchan Kim, Jinhyung Jeon, Jongsoo Lee, Won Sik Jang, Seung Hwan Lee, Woong Kyu Han, Young Deuk Choi, Kyo Chul Koo, Kang Su Cho, Byung Ha Chung, Won Sik Ham

A mixed methods process evaluation: understanding the implementation and delivery of HIV prevention services integrated within sexual reproductive health (SRH) with or without peer support amongst adolescents and young adults in rural KwaZulu-Natal, South Africa

Thembelihle Zuma, Jacob Busang, Sphesihle Hlongwane, Glory Chidumwa, Dumsani Gumede, Manono Luthuli, Jaco Dreyer, Carina Herbst, Nonhlanhla Okesola, Natsayi Chimbindi, Nuala McGrath, Lorraine Sherr, Janet Seeley, Maryam Shahmanesh

POStoperative INTELLiVENT-adaptive support VEntilation in cardiac surgery patients (POSITiVE) II—study protocol of a randomized clinical trial

Martin H. Bernardi, Dominique Bettex, Laura A. Buiteman–Kruizinga, Ashley de Bie, Matthias Hoffmann, Janine de Kleijn, Simon Corrado Serafini, Manon A. Molenaar, Frederique Paulus, Jasminka Peršec, Ary Serpa Neto, Reto Schuepbach, Paolo Severgnini, Andrej Šribar, Marcus J. Schultz, Edda Tschernko

Harnessing health information technology to promote equitable care for patients with limited English proficiency and complex care needs

Inna Strechen, Patrick Wilson, Targ Eltalhi, Kimberly Piche, Dan Tschida-Reuter, Diane Howard, Bruce Sutor, Ing Tiong, Svetlana Herasevich, Brian Pickering, Amelia Barwise

PEMOCS: Evaluating the effects of a concept-guided, PErsonalised, MOtor-Cognitive exergame training on cognitive functions and gait in chronic Stroke—study protocol for a randomised controlled trial

S.K. Huber, R.H. Knols, J.P.O. Held, M. Betschart, E.D. de Bruin

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  • Study protocol

Coerced consent in clinical research: study protocol for a randomized controlled trial

Connor T. A. Brenna, Nancy Walton, Melanie Cohn, Urooj Siddiqui, Ella Huszti, Richard Brull

A multi-centric, single-blinded, randomized, parallel-group study to evaluate the effectiveness of nasoalveolar moulding treatment in non-syndromic patients with complete unilateral cleft lip, alveolus and palate (NAMUC study): a study protocol for a randomized controlled trial

Badri Thiruvenkatachari, Krishnamurthy Bonanthaya, Anne Marie Kuijpers Jagtman, Jonathan Sandler, Rajesh S Powar, Syed Altaf Hussain, B. Subramaniyan, Nitin Bhola, Hari Kishore Bhat, Varun Ramachandra, Sylvia Jayakumar, Puneet Batra, Subhiksha Chakkaravarthi, V. Thailavathy, Manoj Prathap, Thulasiram Elumalai, Karthika Nambiar, Charanya Vijayakumar, Ravi Kumar Mahajan, Sundereshwer Chander Sood, Sukhdeep Singh Kahlon, Shruti Bijapur, Ranjit Haridas Kamble, K. M. Keluskar, Amit Nilgar, Faizan Ahmed Khan, Devika Das, Swetha Sridhar, Adrija Buch, Shuba Kumar, Rani Mohanraj, Stefan Listl, Samiksha Chopra, Vikrant Jadhav, Anika Arora, Chintan Valiya, Madhuri Pattamata

  • Open Access
  • Research

Caregiver recruitment strategies for interventions designed to optimize transitions from hospital to home: lessons from a randomized trial

Allison M. Gustavson, Molly J. Horstman, Jodie A. Cogswell, Diane E. Holland, Catherine E. Vanderboom, Jay Mandrekar, William S. Harmsen, Brystana G. Kaufman, Cory Ingram, Joan M. Griffin

FIRE Stones: impact of forced diuresis on the residual fragment rate after flexible ureteroscopy for destruction of kidney stones with laser—protocol for a randomized controlled two-parallel group multicenter trial with blinding evaluation

ML. Letouche, B. Giraudeau, MS. Agier, F. Bruyere

  • Open Access
  • Correction

Correction: Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design

L. A. Daamen, I. W. J. M. van Goor, V. P. Groot, P. C. M. Andel, L. A. A. Brosens, O. R. Busch, G. A. Cirkel, N. Haj Mohammad, H. D. Heerkens, I. H. J. T. de Hingh, F. Hoogwater, H. W. M. van Laarhoven, M. Los, G. J. Meijer, V. E. de Meijer, R. Pande, K. J. Roberts, J. Stoker, M. W. J. Stommel, G. van Tienhoven, R. C. Verdonk, H. M. Verkooijen, F. J. Wessels, J. W. Wilmink, M. G. Besselink, H. C. van Santvoort, M. P. W. Intven, I. Q. Molenaar

An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus an aminoglycoside + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial—an update to the published protocol

Rindra Vatosoa Randremanana, Mihaja Raberahona, Mamy Jean de Dieu Randria, Josephine Bourner, Gabriella Zadonirina, Hanitra Razananaivo, Théodora Mayouya-Gamana, Reziky Mangahasimbola, Elise Pesonel, Annelies Gillesen, Minoarisoa Rajerison, Voahangy Andrianaivoarimanana, Tansy Edwards, Peter Horby, Piero Olliaro

Role of central endpoint adjudication and challenges in trials on neonatal sepsis—a case of ProSPoNS trial

Anju Pradhan Sinha, Dilip Raja, Kamlesh S. Mahajan, Piyu Sharma, Subodh S. Gupta, Ramesh Poluru, Anand S. Kawade, Girish Dayma, Sunil Sazawal, Ashish Bavdekar, Sailajanandan Parida, Sushma Nangia, Abhishek V. Raut, Adhisivam Bethou, Prabhabati Devi, Makrand Gorpade, Tharika Fatima, Rashmita Nayak, Arti Kapil, Mohd. Azam, Pearlin A. Khan, Ravindra Mohan Pandey, Narendra Kumar Arora, Dixit Prajapati, Apoorva Mathur, Pankaj Gupta, Payal Kumari

Effect of in-line filtration in newborns: study protocol of the Intravenous Neonatal Central Access Safety (INCAS) randomized controlled trial

Francesco Cresi, Elena Maggiora, Cecilia Capetti, Martina Capitanio, Mattia Ferroglio, Elena Spada, Francesca De Matteis, Sara Cosimi, Fabio Mosca, Alessandra Coscia, Arianna Aceti, Orsola Amato, Gina Ancora, Maria Elisabetta Baldassarre, Giovanni Barone, Cristina Bellan, Gabriella Borgarello, Roberto Bottino, Francesca Campagnoli, Antonella Capasso, Maria Grazia Capretti, Mauro Carpentieri, Roberto Cinelli, Luigi Corvaglia, Simonetta Costa, Carlo Dani, Gabriele D’Amato, Vito D’Andrea, Andrea Dotta, Daniele Farina, Stefania Ferrari, Alessandra Foglianese, Annalisa Fracchiolla, Elena Gallo, Stefano Ghirardello, Nicola Laforgia, Gianluca Lista, Mattia Luciano, Chiara Maddaloni, Gianfranco Maffei, Alessandra Maggio, Luca Maggio, Marzia Maino, Giovanna Mangili, Simona Semeria Mantelli, Raffaele Manzari, Isabella Mondello, Maria Pia Natale, Chiara Peila, Flavia Petrillo, Valentina Pivetti, Federica Pontiggia, Francesco Raimondi, Maria Grazia Romitti, Andrea Sannia, Patrizia Savant Levet, Immacolata Savarese, Ferdinando Spagnuolo, Alessia Varalda, Paolo Ernesto Villani, Gianluca Terrin, Dario Ummarino, Giovanni Vento

  • Open Access
  • Suicide
  • Study protocol

Study protocol for an adaptive, multi-arm, multi-stage (MAMS) randomised controlled trial of brief remotely delivered psychosocial interventions for people with serious mental health problems who have experienced a recent suicidal crisis: Remote Approaches to Psychosocial Intervention Delivery (RAPID)

Melissa Pyle, Lucy Loftus, Richard Emsley, Daniel Freeman, Steven Gillard, Andrew Gumley, Justyna Sierpatowska, Lisa Wood, Rory C. O’Connor, Paul Pfeiffer, Sharon Anne Simpson, Nicole Cockayne, Gemma Shields, Ariane Beckley, Helen Beckwith, Maria Filippidou, Callum Glen, Stephanie Allan, Raj Hazzard, Eleanor Longden, Heather Peel, Mark Larsen, Sandra Bucci, Anthony P. Morrison

General skin and nasal decolonization with octenisan® set before and after elective orthopedic surgery in selected patients at elevated risk for revision surgery and surgical site infections—a single-center, unblinded, superiority, randomized controlled trial (BALGDEC trial)

Ines Unterfrauner, Nadja Bragatto-Hess, Thorsten Studhalter, Mazda Farshad, Ilker Uçkay

Community health promotion and medical provision and impact on neonates (CHAMPION2) and support to rural India’s public education system and impact on numeracy and literacy scores (STRIPES2): an update to the study protocol (v 11) for a cluster randomised trial in Madhya Pradesh, India

Siddharudha Shivalli, Ila Fazzio, Chris Frost, Diana Elbourne, Nicholas Magill, Dropti Sharma, Sajjan Singh Shekhawat, Rukmini Banerji, Sridevi Karnati, Harshavardhan Reddy, Padmanabh Reddy, Rakhi Nair, Madan Gopal, Peter Boone

  • Open Access
  • Correction

Correction: Improving medication adherence among persons with cardiovascular disease through m-health and community health worker-led interventions in Kerala; protocol for a type II effectiveness-implementation research-(SHRADDHA-ENDIRA)

Jaideep C. Menon, Denny John, Aswathy Sreedevi, Chandrasekhar Janakiram, R Akshaya, S Sumithra, M. S Aravind, Mathews Numpeli, Bipin Gopal, B. A Renjini, P. K Sajeev, Ravivarman Lakshmanasamy, Abhishek Kunwar

Correction: Letrozole ovulation regimen for frozen-thawed embryo transfer in women with polycystic ovary syndrome: study protocol for a randomized controlled trial

Yanqiu Xie, Min Deng, Weifen Deng, Qi Fan, Yuhua Shi

  • Open Access
  • Study protocol

Study protocol for a stepped-wedge implementation study investigating the intersectoral collaboration of implementing the TREAT INTERACT intervention for primary school teachers and the mhGAP for health care workers for child mental health promotion in Uganda

Ane-Marthe Solheim Skar, Ingunn Marie S. Engebretsen, Nora Braathu, Harriet Aber, Harald Bækkelund, Melf-Jakob Kühl, Marjorie Mukisa, Joyce Sserunjogi Nalugya, Norbert Skokauskas, Vilde Skylstad, Tore Wentzel-Larsen, Juliet Ndimwibo Babirye

  • Open Access
  • Suicide
  • Study protocol

A web-based video messaging intervention for suicide prevention in men: study protocol for a five-armed randomised controlled trial

Jin Han, Aimy Slade, Hiroko Fujimoto, Wu Yi Zheng, Artur Shvetcov, Leonard Hoon, Joost Funke Kupper, Manisha Senadeera, Sunil Gupta, Svetha Venkatesh, Kon Mouzakis, Yuanyuan Gu, Anam Bilgrami, Noura Saba, Henry Cutler, Philip Batterham, Katherine Boydell, Fiona Shand, Alexis Whitton, Helen Christensen

  • Open Access
  • Research

The SHOW RESPECT adaptable framework of considerations for planning how to share trial results with participants, based on qualitative findings from trial participants and site staff

Annabelle South, Claire Snowdon, Eva Burnett, Barbara E. Bierer, Katie Gillies, Talia Isaacs, Matthew R. Sydes

Comparison of the effect of combined usage of povidone-iodine irrigation and topical vancomycin powder to the use of povidone-iodine irrigation alone on the periprosthetic joint infection incidence rate in patients undergoing primary total hip and knee arthroplasty: a protocol for multicenter prospective randomized clinical trial

Michał Kułakowski, Karol Elster, Mateusz Szymczak, Paweł Ślęczka, Mariusz Baumgart, Aleksandra Królikowska, Paweł Reichert

Smartphone-based intervention for postpartum depressive symptoms (Smart-e-Moms): study protocol for a randomized controlled trial

Daria Daehn, Caroline Meyer, Viola Loew, Jessica Wabiszczewicz, Steffi Pohl, Maria Böttche, Silke Pawils, Babette Renneberg

Prepare Romania: study protocol for a randomized controlled trial of an intervention to promote pre-exposure prophylaxis adherence and persistence among gay, bisexual, and other men who have sex with men

Corina Lelutiu-Weinberger, Mircea L. Filimon, Anna M. Zavodszky, Mihai Lixandru, Lucian Hanu, Cristina Fierbinteanu, Raluca Patrascu, Adrian Streinu-Cercel, Sergiu Luculescu, Maria Bora, Irina Filipescu, Cristian Jianu, Lisa B. Heightow-Weidman, Aimee Rochelle, Brian Yi, Nickie Buckner, Sarit A. Golub, Ilana Seager van Dyk, Julian Burger, Fan Li, John E. Pachankis

A phase III randomized clinical trial comparing laparoscopic radical hysterectomy based on open state with abdominal radical hysterectomy in patients with early-stage cervical cancer

Xin Zhao, Yansong Liu, Jumin Niu, Yulin Shi

Correction: Effectiveness of a school-based Life Gatekeeper Training Program on suicide prevention in China: protocol for a randomized controlled trial

Diyang Qu, Xuan Zhang, Dongyu Liu, Bowen Liu, Dongyang Chen, Chengxi Cai, Jing An, Shekhar Saxena, Runsen Chen

  • Open Access
  • Research

The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials

Robin Chatters, Olivia Hawksworth, Steven Julious, Andrew Cook

A randomized controlled trial to assess if changing sleep timing can improve glucose metabolism in people with prediabetes and type 2 diabetes

Emma J. Bouman, Romy Slebe, Dirk Jan Stenvers, Petra J. M. Elders, Joline W. J. Beulens, Femke Rutters

The effectiveness of expressive art therapy on infertile women undergoing surgery: study protocol for a randomized controlled trial

Li Liu, Huiyan Yang, Anjiang Lei, Huaxuan You

Development and preliminary evaluation of a suicidal risk assessment protocol in a randomised controlled trial using the Patient Health Questionnaire (PHQ-9)

Vari Wileman, Serena McGuinness, Louise Sweeney, Christine Norton, Laura Miller, Imogen Stagg, Ronan O’Carroll, Rona Moss-Morris

Optimising a digitally delivered behavioural weight loss programme: study protocol for a factorial cluster randomised controlled trial

Gina M. Wren, Dimitrios A. Koutoukidis, Jadine Scragg, Grace Preston, Marianne Hennessy, Daisy Estephane, Michael Whitman, Susan A. Jebb

Prenatal affective cognitive training to reduce the risk of postpartum depression (PACT): study protocol for a randomized controlled trial

Anne J. Bjertrup, Jeanne Kofoed, Ida Egmose, Katrine Wendelboe, Victoria Southgate, Mette S. Væver, Kamilla W. Miskowiak

Prompt closure versus gradual weaning of external ventricular drain for hydrocephalus following aneurysmal subarachnoid haemorrhage: a statistical analysis plan for the DRAIN randomised clinical trial

Tenna Capion, Alexander Lilja-Cyron, Marianne Juhler, Kirsten Møller, Angelika Sorteberg, Pål André Rønning, Frantz Rom Poulsen, Joakim Wismann, Anders Emil Schack, Celina Ravlo, Jørgen Isaksen, Jane Lindschou, Christian Gluud, Tiit Mathiesen, Markus Harboe Olsen

Study on the preventive effect of dexmedetomidine on anesthetic associated sleep disturbance in young to middle-aged female patients undergoing hysteroscopy: a study protocol for a crossover randomized controlled trial

Xueru Li, Lijuan Yan, Linhong Wang, Hanshen Chen, Bin Yang

Effect of lung volume preservation during spontaneous breathing trial on successful extubation in patients receiving mechanical ventilation: protocol for a multicenter clinical trial

Carles Subirà, Gina Rognoni, Herbert Baquerizo, Carolina García, Sara Cabañes, Maria de la Torre, Beatriz Quevedo, Cristina Pedrós, Ana I. Tizón, Natalia Murillo, Laura Parro, Fernando Eiras, Gemma Rialp, Susana Altaba, Alejandro González-Castro, Andrés F. Pacheco, Pablo Bayoumi, Norma Gómez-Medrano, Imma Vallverdú, Áurea Higón, María D. Navarro, Alirio Falcón, Elena Keough, David Arizo, Juan F. Martínez, Núria Durán, Raquel Rodríguez, Melinda R. Popoviciu-Koborzan, Isabel Guerrero, Pablo Concha, Patricia Barral, Montserrat Batlle, Sílvia Cano, Silvia Garcia-Castrillon, Xavier Andorrà, Yenifher Tua, Anna Arnau, Rafael Fernández

The UPDATE trial (UVB Phototherapy in Dermatology for ATopic Eczema): study protocol for a randomized controlled trial of narrowband UVB with optimal topical therapy versus optimal topical therapy in patients with atopic eczema

Eva Knöps, Phyllis Spuls, Ruben Duijnhoven, Marcel Dijkgraaf, Marit van Barreveld, Bernd Arents, Annefloor van Enst, Floor Garritsen, Maruschka Merkus, Pina Middelkamp-Hup, Annelie Musters, Angela Bosma, Ariënna Hyseni, Jitske Dijkstra, Dirk Jan Hijnen, Louise Gerbens

Statistical analysis plan for cluster randomised trial to evaluate a community-level complementary food safety and hygiene and nutrition intervention in Mali: the MaaCiwara study

Laura Quinn, James Martin, Evans Asamane, Semira Manaseki-Holland, Richard J. Lilford, Lacina Traore, Jacqueline Thompson, Samuel I. Watson, Karla Hemming

A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with bronchiolitis: design and statistical analysis plan

Christopher M. Horvat, Srinivasan Suresh, Nathan James, Rajesh K. Aneja, Alicia K. Au, Scott Berry, Arthur Blumer, Kelly Bricker, Robert S. B. Clark, Heidilyn Dolinich, Sheila Hahner, Christina Jockel, Jordan Kalivoda, India Loar, Denee Marasco, Adrienne Marcinick, Oscar Marroquin, Jonathan O’brien, Jonathan Pelletier, Sriram Ramgopal, Shekhar Venkataraman, Derek C. Angus, Gabriella Butler

Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC): study protocol for an adaptive randomised controlled clinical trial

David W. J. Griffin, Michael Dymock, Germaine Wong, C. Orla Morrissey, Sharon R. Lewin, Allen C. Cheng, Kirsten Howard, Julie A. Marsh, Kanta Subbarao, Michelle Hagenauer, Janine Roney, Anthony Cunningham, Tom Snelling, James H. McMahon

  • Open Access
  • Study protocol

Hope Groups: a protocol for a cluster randomized controlled trial of psychosocial, mental health, and parenting support groups for Ukrainian caregivers during war and conflict

Sydney Tucker, Nicole Baldonado, Olha Ruina, Oliver Ratmann, Seth Flaxman, Lyudmyla Bryn, Jamie Lachman, Evgenia Taradaika, G. J. Melendez-Torres, Inge Vallance, Philip Goldman, Lucie Cluver, Susan Hillis

Reflections on the challenges of conducting an international multicentre randomized controlled trial of balance training in addition to pulmonary rehabilitation and its impact on fall incidence in people with COPD

Anastasia N. L. Newman, Marla K. Beauchamp, Cindy Ellerton, Roger Goldstein, Jennifer A. Alison, Gail Dechman, Kimberley J. Haines, Samantha L. Harrison, Anne E. Holland, Annemarie L. Lee, Alda Marques, Lissa Spencer, Michael K. Stickland, Elizabeth H. Skinner, Pat G. Camp, Michelle E. Kho, Dina Brooks

  • Open Access
  • Commentary

Personality vulnerabilities and adverse event reporting in phase 1 clinical studies

Joanna Skommer, Krish Gunesh, Thomas M. Polasek

Correction: The effectiveness of multidisciplinary interventions based on health belief model on musculoskeletal pain in the elderly living in nursing homes: a study protocol for a randomized controlled trial

Sogand Habibi, Sedigheh Sadat Tavafan, Reza Maghbouli, Ali Montazeri

Neoadjuvant therapy of sequential TACE, camrelizumab, and apatinib for single huge hepatocellular carcinoma (NEO-START): study protocol for a randomized controlled trial

Yun Hao, Fei Xie, Yongjie Zhou, Chuan Li, Xiaoyun Zhang, Junyi Shen, Minghong Yao, Xin Sun, Jin Zhou, Tianfu Wen, Wei Peng

Email recruitment for chronic pain clinical trials: results from the LAMP trial

John E. Ferguson, Emily Hagel Campbell, Ann Bangerter, Lee J. S. Cross, Kelli D. Allen, Kimberly Behrens, Mariah Branson, Collin Calvert, Jessica K. Friedman, Sierra Hennessy, Laura A. Meis, Brent C. Taylor, Diana J. Burgess

Translated and culturally adapted internet-delivered cognitive therapy for social anxiety disorder in Japanese clinical settings: study protocol for a randomised controlled trial

Naoki Yoshinaga, Graham R. Thew, Yuta Hayashi, Hiroki Tanoue, Michikazu Nakai, David M. Clark

Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial

Mariam Hachem, Tracey Hearn, Ray Kelly, Audrey Eer, Belinda Moore, Christine Sommerville, Sharon Atkinson-Briggs, Stephen Twigg, Meagan Freund, David O’Neal, David Story, Alex Brown, Anna McLean, Ashim Sinha, John Furler, Richard O’Brien, An Tran-Duy, Philip Clarke, Sabine Braat, Digsu N. Koye, Sandra Eades, Luke Burchill, Elif Ekinci

The multifactorial approach and the food allergen-specific substitutive diet as a tool to manage and ameliorate adverse reactions to foodstuffs in adulthood: study protocol for a randomized controlled trial—the ALASKA study

Lisset Pantoja-Arévalo, Eva Gesteiro, Margarita Pérez-Ruiz, Jaime López-Seoane, Patricia Wusterhausen, Torsten Matthias, Rafael Urrialde, Marcela González-Gross

Protocol update for a multi-centre randomised controlled trial of exercise rehabilitation for people with pulmonary hypertension: the SPHERe trial

Stuart Ennis, Julie Bruce, Harbinder Sandhu, Mariam Ratna, Ranjit Lall, Chen Ji, James Mason, Rebecca Kandiyali, Kate Seers, Prithwish Banerjee, Stephanie J. C. Taylor, Elizabeth Robertson, Martin Underwood, Gordon McGregor

Early treatment for children with mental health problems and genetic conditions through a parenting intervention (The GAP): study protocol for a pragmatic randomized controlled trial

Mercedes Serrano, Maria Elias, Marta Llorens, Mercè Bolasell, Helena Vall-Roqué, Laia Villalta

The effect of time-restricted eating on arterial stiffness indices in men with metabolic syndrome: study protocol for a randomized controlled trial

Aliyeh Ghannadzadeh Yazdi, Mohammad Masoumvand, Elena Philippou, Alireza Hatami, Zahra Dehnavi, Hanieh Barghchi, Maryam Ahmadi-Khorram, Ali Jafarzadeh Esfehani, Mohsen Nematy

The effect of bilateral ultrasound-guided erector spinae plane block on postoperative pain control in idiopathic scoliosis patients undergoing posterior spine fusion surgery: study protocol of a randomized controlled trial

Jingchun Gao, Yi Ren, Dong Guo

Update: Vitamin D3 and calcium carbonate supplementation for adolescents with HIV to reduce musculoskeletal morbidity and immunopathology (VITALITY trial): study protocol for a randomised placebo-controlled trial

Nyasha Veronica Dzavakwa, Molly Chisenga, Grace McHugh, Suzanne Filteau, Celia Louise Gregson, Lackson Kasonka, Katharina Kranzer, Hildah Banda Mabuda, Hilda Mujuru, Nicol Redzo, Sarah Rowland-Jones, Ulrich E. Schaible, Victoria Simms, Rashida Abbas Ferrand, Dan Hameiri-Bowen, Esther Gea-Mallorqui, Matthias Hauptmann, Cynthia Kahari, Christoph Leschczyk, Tafadzwa Madanhire, Tadious Manyanga, Kudakwashe Mutasa, Sandra Rukobo, Ruramayi Rukuni, Tsitsi S. Mudzingwa, Veronica Sunkutu, Mizinga Tembo, Cassandra Namukonda, Paul Kelly, Adrian Martineau, Kate Ward, Moherndran Archary, John Pettifor, Grace John-Stewart, Adeodata Kekitiinwa, Carl Lombard, Helen A. Weiss

  • Open Access
  • Study protocol

Effects of starting one lung ventilation and applying individualized PEEP right after patients are placed in lateral decubitus position on intraoperative oxygenation for patients undergoing thoracoscopic pulmonary lobectomy: study protocol for a randomized controlled trial

Qing-Yuan Wang, Yang Zhou, Meng-Rui Wang, You-You Jiao

Glaucoma Rehabilitation using ElectricAI Transcranial Stimulation (GREAT)—study protocol for randomized controlled trial using combined perceptual learning and transcranial electrical stimulation for vision enhancement

Shuwen Jia, Xiaolin Mei, Lilin Chen, Lok Hin Chan, Celia Tsang, Venus Suen, Tingni Li, Myo Win Zaw, Amanda Liu, Ben Thompson, Bernhard Sabel, George Woo, Christopher K. S. Leung, Shea-ping Yip, Dorita H. F. Chang, Allen M. Y. Cheong

Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP): study protocol for a multicenter, randomized, adaptive allocation clinical trial to identify the optimal duration of induced hypothermia for neuroprotection in comatose, adult survivors of after out-of-hospital cardiac arrest

William J. Meurer, Florian F. Schmitzberger, Sharon Yeatts, Viswanathan Ramakrishnan, Benjamin Abella, Tom Aufderheide, William Barsan, Justin Benoit, Scott Berry, Joy Black, Nia Bozeman, Kristine Broglio, Jeremy Brown, Kimberly Brown, Noelle Carlozzi, Angela Caveney, Sung-Min Cho, Hangyul Chung-Esaki, Robert Clevenger, Robin Conwit, Richelle Cooper, Valentina Crudo, Mohamud Daya, Deneil Harney, Cindy Hsu, Nicholas J. Johnson, Imad Khan, Shaveta Khosla, Peyton Kline, Anna Kratz, Peter Kudenchuk, Roger J. Lewis, Chaitra Madiyal, Sara Meyer, Jarrod Mosier, Marwan Mouammar, Matthew Neth, Brian O’Neil, James Paxton, Sofia Perez, Sarah Perman, Cemal Sozener, Mickie Speers, Aimee Spiteri, Valerie Stevenson, Kavita Sunthankar, Joseph Tonna, Scott Youngquist, Romergryko Geocadin, Robert Silbergleit, Sarah Abdallah, David Adler, Sachin Agarwal, Rachel Ambroch, Amer Ardati, Farhan Ayaz, Maranatha Ayodele, Meenakshi Balakrishnan, Aaron Barksdale, Torben K. Becker, David Beiser, Margaret Beyer, Ethan Brandler, Lauren Buck, Margaret Carlson, Jeffrey Caterino, Dong Chang, Wan-Tsu Chang, M. Riccardo Colella, Alexandrea Cronin, Anna Curtis, Marina Del Rios, Alan Denney, Kenneth W. Dodd, Brian Driver, Timothy Ellender, Jonathan Elmer, Dominique Evans, Octavio Falcucci, Jennifer Fowler, Madison Frazier, Megan Fuentes, David Gaieski, Nina Gentile, Emily Gilmore, Adit Ginde, Joshua Goldstein, Gillian Grafton, Matthew Greer, Valerie Griffeth, Vedant Gupta, Alex Hall, Grace Hall, Christopher Harden, Robert Harrison, Jason Haukoos, J. Claude Hemphill, Terra Hiller, Karen Hirsch, Benton Hunter, Cameron Hypes, Ahamed Idris, Nastasia James, Namita Jayaprakash, Elizabeth Jones, Christopher Jones, Gregory Kapinos, Sarah Katsandres, Adam Kessler, Joy Kim, Kathryn Kisken, Howard Klausner, Jennifer Klavens, William Knight, Michael Christopher Kurz, Jacob Labinski, Nancy Le, Christopher Lewandowski, Alexander Limkakeng, Carol Lynn Lyle, David Marks, Ellen Maruggi, Linda Mattrisch, Teresa May, Thomas Mazzocco, Brenna McKaig, Eric Melnychuk, Lisa H. Merck, Valerie Mika, Joseph Miller, Benjamin Miller, James Miner, Wazim Mohamed, Karli Molignoni, Cindy Montero, Kayla Muschong, Sung Min Na, Rahul Nanchal, Robert Neumar, Daniel Nishijima, Katherine Nugent, Robert E. O’Connor, Gloria Obialisi, Joseph Ornato, Alex Parker, Blair Alden Parry, Nivedita Patkar, Jonathan Paul, MaryAnn Peberdy, Lars-Kristofer Peterson, Tedra Porter, Matthew Prekker, Peter Pruitt, Yanina Purim-Shem-Tov, Michael Puskarich, Dominica Randazzo, Lauren Remboski, Joshua Reynolds, Jon Rittenberger, Christopher Roberts, Robert Rodriguez, Birendra Sah, Christian Sebat, Rebecca Sell, Reza Shaker, Shelby Shelton, Arun Sherma, Michael Silverman, Bonnie Siry, Bill Spurlock, Vasisht Srinivasan, Nicholas Stanley, Sidney Starkman, Edward Suh, Timothy Thayer, Michael Thomas, Kathryn Thompson, Juliana Tolles, Shahed Toossi, Sam Torbati, Abigail Vollmer, Henry Wang, Gabriel Wardi, Nicholas Wesner, Kathleen Wilson, Charles Wira, Nancy Wood, Kabir Yadav, Jenny Yang, Lara Zimmermann, Michael D. Zwank

  • Open Access
  • Methodology

Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE Project

Joanna Black, Patrick Julier, Lucy Eldridge, Vicki S. Barber

  • Open Access
  • Study protocol

Improving Diabetes Equity and Advancing Care (IDEA) to optimize team-based care at a safety-net health system for Black and Latine patients living with diabetes: study protocol for a sequential, multiple assignment, randomized trial

Jacquelyn Jacobs, Patricia Labellarte, Helen Margellos-Anast, Lizbeth Garcia, Fares Qeadan, Benjamin Tingey, Kelsey Barnick, Alyn Dougherty, Christina Wagener

A deprescribing programme aimed to optimise blood glucose-lowering medication in older people with type 2 diabetes mellitus, the OMED2-study: the study protocol for a randomised controlled trial

Charlotte Andriessen, Marieke T. Blom, Beryl A. C. E. van Hoek, Anna W. de Boer, Petra Denig, G. Ardine de Wit, Karin Swart, Angela de Rooij-Peek, Rob J. van Marum, Jacqueline G. Hugtenburg, Pauline Slottje, Daniël van Raalte, Liselotte van Bloemendaal, Ron Herings, Giel Nijpels, Rimke C. Vos, Petra J. M. Elders

Diabetes Telemedicine Mediterranean Diet (DiaTeleMed) Study: study protocol for a fully remote randomized clinical trial evaluating personalized dietary management in individuals with type 2 diabetes

Lauren T. Berube, Collin J. Popp, Margaret Curran, Lu Hu, Mary Lou Pompeii, Souptik Barua, Emma Bernstein, Vanessa Salcedo, Huilin Li, David E. St-Jules, Eran Segal, Michael Bergman, Natasha J. Williams, Mary Ann Sevick

Statistical considerations for the platform trial in COVID-19 vaccine priming and boosting

Michael Dymock, Charlie McLeod, Peter Richmond, Tom Snelling, Julie A. Marsh

  • Open Access
  • Obesity
  • Study protocol

Effectiveness and cost-effectiveness of a 1-year dietary and physical activity intervention of childhood obesity—study protocol for a randomized controlled clinical trial

A. Martikainen, AM Eloranta, U. Schwab, T. Örmälä

Commentary: The North West London Clinical Trials Alliance: efficiency and innovation in clinical trial delivery

Patrick Kierkegaard, Bowen Su, Richard Wong, Marta Boffito, Suki Balendra

Designing an implementation science clinical trial to integrate hypertension and cardiovascular diseases care into existing HIV services package in Botswana (InterCARE)

Nabila Youssouf, Gaone Edwin Mogaetsho, Thato Moshomo, Tendani Gaolathe, Ponego Ponatshego, Mareko Ramotsababa, Onkabetse Julia Molefe-Baikai, Evelyn Dintwa, Tsaone Kiki, Amelia E. Van Pelt, Karen Steger-May, Laura M. Bogart, Shabbar Jaffar, Pooja Gala, Duolao Wang, Khumo Seipone, Kara Bennett, Kathleen Wirth Hurwitz, Kago Kebotsamang, Lisa R. Hirschhorn, Mosepele Mosepele

Impact of varied anesthesia maintenance strategies on postoperative respiratory complications in pediatric patients undergoing tonsillectomy and adenoidectomy (AmPRAEC study): study protocol for a multicenter randomized, double-blind clinical trial

Fangming Shen, Qin Zhang, Yuqing Xue, XingHe Wang, Wenlan Cai, Wenbo Liu, Yuchen Dai, Jie Sun

Efficacy of vitamin C on chemotherapy-related anemia in pancreatic cancer: study protocol for a randomized controlled trial

Xinyue Wang, Xinzhe Zhu, Yi Liu, He Liu, Zhiwen Xiao, Guopei Luo

  • Open Access
  • Study protocol

Conservative or operative therapy in patients with a fragility fracture of the pelvis: study protocol for a prospective, randomized controlled trial

R. A. Haveman, B. J. M. van de Wall, M. Rohner, F. J. P. Beeres, P. C. Haefeli, R. Baumgärtner, R. Babst, B.-C. Link

  • Open Access
  • Myopia
  • Study protocol

The efficacy and safety of combination therapy of repeated low-level red light and defocus-incorporated multiple segments spectacle lenses for myopia control in children: the study protocol for a 12-month, randomized, parallel-controlled, and single-center clinical trial

Hongmei Zhang, Desheng Song, Ruihua Wei

  • Open Access
  • Research

Effect of nano-curcumin supplementation on cardiometabolic risk factors, physical and psychological quality of life, and depression in patients with coronary slow flow phenomenon: a randomized double-blind clinical trial

Mitra Soltani, Mohammad Javad Hosseinzadeh-Attar, Mahsa Rezaei, Elham Alipoor, Ali Vasheghani-Farahani, Mehdi Yaseri, Seyed Mahdi Rezayat

The combined effect of transcutaneous electrical nerve stimulation and transcutaneous auricular vagus nerve stimulation on pressure and heat pain thresholds in pain-free subjects: a randomized cross-over trial

Richard E. Liebano, Noura Awad, Christopher Bellino, Katherine Bray, Heidi Rosentrater, Joshua Roy, Camryn Tate

  • Open Access
  • Anxiety
  • Study protocol

The effect of fear-avoidance intervention on kinesiophobia and self-efficacy in patients after percutaneous coronary intervention: study protocol for a clinical randomized controlled trial

Qi Li, Lingjun Yan, Wenhui Xing, Ce Zhou, Yu Li, Boya Wan, Jingjing Piao, Yanmei Gu

The effect of astaxanthin supplementation on inflammatory markers, oxidative stress indices, lipid profile, uric acid level, blood pressure, endothelial function, quality of life, and disease symptoms in heart failure subjects

Shirin Ghotbbodin Mohammadi, Awat Feizi, Mohammad Bagherniya, Davood Shafie, Ali-Reza Ahmadi, Marziyeh Kafeshani

The ReInvigorate Study—phrenic nerve-to-diaphragm stimulation for weaning from mechanical ventilation: a protocol for a randomized pivotal clinical trial

Katie Schaaf, Christopher M. Mullin, Kyle W. Cunningham, Jonathan Eaton, Steven A. Conrad

Efficacy of tranexamic acid versus placebo in reducing blood loss during burn excisional surgery: a multi-center, double-blind, parallel, randomized placebo-controlled clinical trial (TRANEX)

R. K. Gigengack, J. Slob, A. Meij-de Vries, E. Bosma, S. A. Loer, J. S. H. A. Koopman, C. H. van der Vlies

Digital endpoints in clinical trials: emerging themes from a multi-stakeholder Knowledge Exchange event

Mia S. Tackney, Amber Steele, Joseph Newman, Marie-Christine Fritzsche, Federica Lucivero, Zarnie Khadjesari, Jennifer Lynch, Rosemary A. Abbott, Vicki S. Barber, James R. Carpenter, Bethan Copsey, Elin H. Davies, William G. Dixon, Lisa Fox, Javier González, Jessica Griffiths, Chloe H. L. Hinchliffe, Magdalena A. Kolanko, Dylan McGagh, Aryelly Rodriguez, George Roussos, Karen B. E. So, Louise Stanton, Mark Toshner, Frances Varian, Paula R. Williamson, Belay B. Yimer, Sofía S. Villar

Comparison of postoperative analgesia effects between subcostal anterior quadratus lumborum block and transversus abdominis plane block in bariatric surgery: a prospective randomized controlled study

Wuhao Liao, Xinhai Wu, Shuang Yin, Ying Yang, Liwei Ren, Bucheng Liao

Older adults exercising ON TIME: protocol for a randomized controlled cross-over study to assess the effect of physical activity timing on insomnia severity

Gali Albalak, Raymond Noordam, Marjan van der Elst, Laura Kervezee, Vasileios Exadaktylos, David van Bodegom, Diana van Heemst

  • Open Access
  • Correction

Correction: Can flash glucose monitoring improve glucose management for Aboriginal and Torres Strait Islander peoples with type 2 diabetes? A protocol for a randomised controlled trial

Mariam Hachem, Tracey Hearn, Ray Kelly, Audrey Eer, Belinda Moore, Christine Sommerville, Sharon Atkinson-Briggs, Stephen Twigg, Meagan Freund, David O’Neal, David Story, Alex Brown, Anna McLean, Ashim Sinha, John Furler, Richard O’Brien, An Tran-Duy, Philip Clarke, Sabine Braat, Digsu N. Koye, Sandra Eades, Luke Burchill, Elif Ekinci

Study protocol: perinatal mood treatment study

Kate Wolitzky-Taylor, Misty C. Richards, Amelia Welborn, Vanessa McDonald, Inna Arnaudova, Scott Fears, Heather O’Mahen, Jill M. Newby, Mike Millard, Allison V. Metts, Alan Stein, Nelson Freimer, Michelle G. Craske

  • Open Access
  • Obesity
  • Study protocol

The Ex-Timing trial: evaluating morning, afternoon, and evening exercise on the circadian clock in individuals with type 2 diabetes and overweight/obesity—a randomized crossover study protocol

João P. Magalhães, Estela C. Oliveira, Megan Hetherington-Rauth, Filipe Jesus, Maria Clarissa Rodrigues, João F. Raposo, Rogério T. Ribeiro, Cristina Caetano, Luís B. Sardinha

  • Open Access
  • Commentary

Clinical trials with mechanism evaluation of intervention(s): mind the power and sample size calculation

Kim May Lee, Jennifer Hellier, Richard Emsley

Evaluation of a group-based online informed consent conversation (eConsent) in participants from a low-risk vaccination clinical trial

Ngoc H. Tan, Melvin Lafeber, Roos S. G. Sablerolles, Isabelle Veerman Roders, Anna van de Hoef, Karenin van Grafhorst, Leo G. Visser, Douwe F. Postma, Abraham Goorhuis, Wim J. R. Rietdijk, P. Hugo M. van der Kuy

Short-term outcomes and inflammatory stress response following laparoscopy or robotic-assisted transabdominal preperitoneal inguinal hernia repair (TAPP): study protocol for a prospective, randomized trial (ROLAIS)

Alexandros Valsamidis Valorenzos, Kristian Als Nielsen, Karsten Kaiser, Per Helligsø, Mark Bremholm Ellebæk, Allan Dorfelt, Sofie Ronja Petersen, Andreas Kristian Pedersen, Michael Festersen Nielsen

  • Open Access
  • Study protocol

Efficacy of a transdiagnostic Internet prevention approach in adolescents (EMPATIA study): study protocol of a randomized controlled trial

Anja Hirsig, Xenia Anna Häfeli, Stefanie Julia Schmidt

The evaluation of nightshade elimination diet (NED) on inflammatory and rheumatologic markers of rheumatoid arthritis patients: study protocol for a randomized controlled trial

Ashkan Golmohammadi, Mahak Hosseinikia, Mohammad Kazem Sadeghi, Dariush Golampur, Zahra Hosseinzadeh, Seyed Bahman Panahande

  • Open Access
  • Methodology

Silence is golden, but my measures still see—why cheaper-but-noisier outcome measures in large simple trials can be more cost-effective than gold standards

Benjamin Woolf, Hugo Pedder, Henry Rodriguez-Broadbent, Phil Edwards

Mechanisms of treatment effects using allogeneic, umbilical cord-derived mesenchymal stromal stem cells (MSCs) in knee osteoarthritis: a pharmacological clinical study protocol

Urban Švajger, Matic Kolar, Andrej Kobold, Matej Drobnič

Efficacy and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain: a single-centre, randomized and open-label controlled trial

Huan Wang, Jie Huang, Liyuan Tao, Dongyang Liu, Chunli Song

Application of a simplified transesophageal echocardiography examination sequence in high-risk cardiac surgery

Chunrong Wang, Yuan Tian, Bing Bai, Kai He, Haisong Lu, Chunhua Yu, Qi Miao

Land- and water-based aerobic exercise program on health-related outcomes in breast cancer survivors (WaterMama): study protocol for a randomized clinical trial

Cristine Lima Alberton, Luana Siqueira Andrade, Bruno Ezequiel Botelho Xavier, Victor Hugo Guesser Pinheiro, Antonio Ignacio Cuesta-Vargas, Stephanie Santana Pinto

Ultrasound-guided supraclavicular block versus Bier block for emergency reduction of upper limb injuries: statistical analysis plan

Philip Jones, Henry Tsao, Peter J. Snelling

Effects of a nurse-led motor function rehabilitation training program for patients with ischemic stroke and family caregivers: study protocol for a randomized controlled trial

Yue Ding, Juan Xu, Qian-Yu Liang, Jia-Qi Zheng, Feng Wang, Ying Lin, Di-Ya Wang, Jing Su

  • Open Access
  • Study protocol

Move-PCD—a multi-center longitudinal randomized controlled superiority trial on the effect of a 6-month individualized supported physical activity (PA) program on quality of life (QoL) in children, adolescents, and adults with primary ciliary dyskinesia

Anna Teresa Hoffmann, Anna Mai, Klaus Baum, Anne Schlegtendal, Christoph Maier, Julien Stein, Marianne Tokic, Stefanie Dillenhöfer, Thomas Lücke, Nina Timmesfeld, Folke Brinkmann

Magnesium sulphate to prevent perioperative atrial fibrillation in cardiac surgery: a randomized clinical trial

Manon Meerman, Marit Buijser, Lettie van den Berg, Anne-Marthe van den Heuvel, Gerard Hoohenkerk, Vincent van Driel, Luuk Munsterman, Roel de Vroege, Michael Bailey, Rinaldo Bellomo, Jeroen Ludikhuize

  • Open Access
  • Study protocol

The SME tool supporting employers of small- and medium-sized enterprises during the return to work of employees on long-term sick leave: study protocol for a randomized controlled trial and for a process evaluation

Donna C. E. Beerda, Michiel A. Greidanus, Angelique E. de Rijk, Astrid de Wind, Sietske J. Tamminga, Frederieke G. Schaafsma

Study on the application of a segmented sodium citrate solution anticoagulation strategy in critically ill patients receiving CRRT: a prospective, randomized controlled study

Yu Chen, Fang Feng, Hong Guo, Lu Zhang, Jian Liu

Efficacy of personalized repetitive transcranial magnetic stimulation based on functional reserve to enhance ambulatory function in patients with Parkinson’s disease: study protocol for a randomized controlled trial

Seo Jung Yun, Ho Seok Lee, Dae Hyun Kim, Sun Im, Yeun Jie Yoo, Na Young Kim, Jungsoo Lee, Donghyeon Kim, Hae-Yeon Park, Mi-Jeong Yoon, Young Seok Kim, Won Hyuk Chang, Han Gil Seo

Non- or minimally displaced distal radius fractures in adult patients < 50 years of age

Eva A. K. van Delft, Suus G. J. van Bruggen, Nico L. Sosef, Frank W. Bloemers, Niels W. L. Schep, Jefrey Vermeulen

  • Open Access
  • Commentary

Towards an understanding of the ethics of electronic consent in clinical trials

Katherine Sahan, Rohan Wijesurendra, David Preiss, Marion Mafham, Mark Sheehan

  • Open Access
  • Research

Rapid qualitative analysis of recruitment obstacles in the FORVAD (Posterior Cervical Foraminotomy surgery versus Anterior Cervical Discectomy surgery in the treatment of cervical brachialgia) randomised, controlled trial

Rebecca Talbot, Ruchi Higham, Julie Croft, Gemma Ainsworth, Sarah Brown, Rachel Kelly, Deborah Stocken, Simon Thomson, Nikki Rousseau

  • Open Access
  • Research

Adverse event assessment in a parenting programme: experiences from a multisite randomised controlled trial

Inga Frantz, Heather M. Foran, Jamie M. Lachman, Frances Gardner, Robert J. McMahon, Terje Ogden, Judy Hutchings, Madalina Ruxandra Costin, Ivo Kunovski, Marija Raleva, Janina Mueller, Nina Heinrichs

ENhancinG vAGinal dElivery in Greece through educational and behavioral interventions among maternity care providers regarding labor management: the ENGAGE stepped-wedge randomized prospective trial protocol

Nikolaos Vrachnis, Nikolaos Antonakopoulos, Peter von Dadelszen, Marianne Vidler, Georgios Maroudias, Jeffrey Bone, Ash Sandhu, Nikolaos Loukas, Laura Magee, Nikolaos Roussos, Stefania Kassaris, Alexandros Fotiou, Dimitrios Zygouris, Georgios Adonakis, Christodoulos Akrivis, Aris Antsaklis, Apostolos Athanasiadis, Nikolaos Bontis, Angelos Daniilidis, Alexandros Daponte, Georgios Daskalakis, Efthimios Deligeoroglou, Konstantinos Dinas, Peter Drakakis, Angeliki Gerede, Grigorios Grimbizis, Nicoletta Iacovidou, Nikolaos Kambas, Theodoros Katasos, Christos Katsetos, Ilias Katsikis, Antonios Makrigiannakis, Michail Matalliotakis, Christina Messini, Themis Mikos, Nikolaos Nikolettos, Georgios Pados, Minas Paschopoulos, Konstantinos Patsouras, Soultana Siahanidou, Vasileios Sioulas, Chara Skentou, Sofoklis Stavros, Marleen Temmerman, Panagiotis Tsikouras, Vasilios Tsitsis, Nikolaos Vlahos, Alexandros Rodolakis, Aris Papageorghiou, Dimitrios Loutradis

Protocol for a randomized controlled trial of an internet-based prevention intervention for young children at-risk for functional abdominal pain

Rona L. Levy, Tasha B. Murphy, Miranda A. L. van Tilburg, Margaret R. Kuklinski, Jennifer A. Bailey, Homer Aalfs, Isabel Badillo, Hafsah Diakhate, Tonya M. Palermo

  • Open Access
  • Commentary

Designing e-consent protocols for pragmatic clinical trials: case studies from a UKCRC clinical trials unit

M. Hammond, P. Ashford, J. High, L. V. Clark, G. Howard, M. Jones, S. Stirling, C. West

  • Open Access
  • Research

Reaction to at-home air purifiers installed to reduce traffic-related air pollution in near-highway residences

K. Singh-Smith, L. Sprague Martinez, M. Eliasziw, S. Lerman Ginzburg, N. Hudda, GM. Betz, A. Gurcan, T. Vazquez-Dodero, A. Mertl, W. Goldstein-Gelb, W. Zamore, D. Brugge

A Brief Alcohol Intervention (BAI) to reduce alcohol use and improve PrEP outcomes among men who have sex with men in Vietnam: study protocol for a randomized controlled trial

Hao T. M. Bui, Le Minh Giang, Jane S. Chen, Teerada Sripaipan, Ha T. T. Nong, Ngan T. K. Nguyen, Sophia M. Bartels, Sarah L. Rossi, Heidi Hutton, Geetanjali Chander, Hojoon Sohn, Olivia Ferguson, Ha V. Tran, Minh X. Nguyen, Khanh D. Nguyen, Sarah E. Rutstein, Sara Levintow, Irving F. Hoffman, Byron J. Powell, Brian W. Pence, Vivian F. Go, William C. Miller

Efficacy of denervation for osteoarthritis in the proximal interphalangeal joint (DOP): protocol of a randomized controlled trial

Elin M. Swärd, Jonas Beckman, Farnoush Tabaroj, Maria K. Wilcke

  • Open Access
  • Methodology

Patient and public involvement and engagement in the ASCEND PLUS trial: reflections from the design of a streamlined and decentralised clinical trial

Muram El-Nayir, Rohan Wijesurendra, David Preiss, Marion Mafham, Leandros Tsiotos, Sadman Islam, Anne Whitehouse, Sophia Wilkinson, Hannah Freeman, Ryonfa Lee, Wojciech Brudlo, Genna Bobby, Bryony Jenkins, Robert Humphrey, Amy Mallorie, Andrew Toal, Elnora C. Barker, Dianna Moylan, Graeme Thomson, Firoza Davies, Hameed Khan, Ian Allotey, Susan Dickie, John Roberts

  • Open Access
  • Malaria
  • Study protocol

Advancing spatial repellents for malaria control: effectiveness and cost-effectiveness of a spatial repellent under operational use in Northern Uganda—study protocol for a cluster randomized controlled trial

Esther Nakyaze, Suzanne Van Hulle, John Hembling, Emmanuel Arinaitwe, Momar Mbodji, Mary Grace Alwano, Felly Christine Lamwaka, Stephen Tukwasibwe, Samuel Gonahasa, Fang Liu, John P. Grieco, Nicole L. Achee

  • Open Access
  • Study protocol

Every Newborn-Reach Up Early Education Intervention for All Children (EN-REACH)- a parent group intervention for school readiness in Bangladesh, Nepal, and Tanzania: study protocol for a cluster randomized controlled trial

Mohammad Abdul Awal Miah, Jaya Chandna, Rejina Gurung, Nahya Salim Masoud, Proma Paul, Shafiqul Ameen, Omkar Basnet, Mustafa Miraji, Cally Tann, Ismat Ara Mili, A K M Tanvir Hossain, Atique Iqbal Chowdhury, Asraful Alam, Kate Mackinnon Milner, Shams El Arifeen, Ashish KC, Karim Manji, Paul Lynch, Joy E. Lawn, Jena Derakhshani Hamadani, Ziaul Haque Shaikh, Md. Nazmul Hasan, Salma Khatun, Adori Khatun, Monira Aktar, Ahmed Ehsanur Rahman, Chudamani Poudel, Basanta Prasad Koirala, Shova Kumari Adhikari, Arjun Dhakal, Dhanasudhan Chaulagain, Bharat Khatri, Ram Chandra Bastola, Donat Shamba, Josephine Shabani, Mohamed Bakari, Hajra Kizibo, Mohamed Akida, Aisha Mfinanga, Hellena Mariki, Ramadhani Gunda, Seif Bakari, Rachel Lassman, Maria Zurmond

MulTI-domain self-management in older People wiTh OstEoarthritis and multi-morbidities: protocol for the TIPTOE randomised controlled trial

Rachel Deere, Philip Pallmann, Victoria Shepherd, Lucy Brookes-Howell, Andrew Carson-Stevens, Ffion Davies, Emma Dunphy, Preeti Gupta, Mary Hickson, Val Hill, Kate Ingarfield, Nicola Ivins, Fiona Jones, Robert Letchford, Rachel Lowe, Sarah Nash, Paula Otter, Hayley Prout, Elizabeth Randell, Bernadette Sewell, Debs Smith, Robert Trubey, Tom Wainwright, Monica Busse, Kate Button

The EC90 of remifentanil for inhibiting endotracheal intubation responses under anesthesia induction with ciprofol: study protocol for a dose-finding trial with the biased-coin design

Jianing Guo, Fangsheng Xu, Luoyun Li, Zeru Zhang, Baichun Xing, Qin Fan, Zehua Wang, Chunyu Li

WONDER-02: plastic stent vs. lumen-apposing metal stent for endoscopic ultrasound-guided drainage of pancreatic pseudocysts—study protocol for a multicentre randomised non-inferiority trial

Tomotaka Saito, Mamoru Takenaka, Masaki Kuwatani, Shinpei Doi, Hiroshi Ohyama, Toshio Fujisawa, Atsuhiro Masuda, Takuji Iwashita, Hideyuki Shiomi, Nobuhiko Hayashi, Keisuke Iwata, Akinori Maruta, Tsuyoshi Mukai, Saburo Matsubara, Tsuyoshi Hamada, Tadahisa Inoue, Kazuyuki Matsumoto, Sumio Hirose, Nao Fujimori, Kosuke Kashiwabara, Hideki Kamada, Shinichi Hashimoto, Toshiyasu Shiratori, Reiko Yamada, Hirofumi Kogure, Kazunari Nakahara, Takeshi Ogura, Masayuki Kitano, Ichiro Yasuda, Hiroyuki Isayama, Yousuke Nakai, Shunsuke Omoto, Shinya Uemura, Ryota Nakano, Yuta Kawase, Sho Takahashi, Mitsuru Okuno, Yuhei Iwasa, Kensaku Yoshida, Shogo Ota, Masahiro Tsujimae, Arata Sakai, Kentaro Suda, Naminatsu Takahara, Kazunaga Ishigaki, Ryunosuke Hakuta, Tatsuya Sato, Rena Kitano, Motoyasu Kan, Hiroki Nagashima, Yotaro Iino, Koji Takahashi, Kazumichi Kawakubo, Ryo Sugiura, Kazuma Kishi, Hiroki Yonemura, Shunichiro Nozawa, Ryota Nakabayashi, Namima Daisuke, Makoto Hinokuchi, So Nakaji, Kenji Nose, Kei Saito, Shuzo Nomura, Mariko Fujisawa, Nobuyuki Kuniyoshi, Atsushi Okuda, Saori Ueno, Akira Miyano, Nobu Nishioka, Yusuke Satta, Nobuhiro Katsukura, Masahiro Itonaga, Reiko Ashida, Takashi Tamura, Takahiro Shishimoto, Yuki Kawaji, Hironari Kato, Ryosuke Sato, Keijiro Ueda, Katsuhito Teramatsu, Kazuhide Matsumoto

  • Open Access
  • Study protocol

LSDDEP2: study protocol for a randomised, double-dummy, triple-blind, active placebo-controlled, parallel groups trial of LSD microdosing in patients with major depressive disorder

Dimitri Daldegan-Bueno, Carina Joy Donegan, Anna Forsyth, Rachael Louise Sumner, Robin J. Murphy, David B. Menkes, William Evans, Nicholas Hoeh, Frederick Sundram, Lisa M. Reynolds, Rhys Ponton, Alana Cavadino, Todd Smith, Partha Roop, Nathan Allen, Binu Abeysinghe, Darren Svirskis, Mahima Bansal, Suresh Muthukumaraswamy

Clinical evaluation of enhanced recovery versus conventional care in the perioperative period for intradural extramedullary spinal tumors: a study protocol for a multicenter, randomized controlled trial

Jing Chen, Lishuang Chen, Xueqin Hu, Zengna Xing, Yuhui Sun, Fabin Lin, Rui Wang, Chunmei Chen, Yanjuan Lin

Efficacy study comparing a CBT-I developed for shift workers (CBT-I-S) to standard CBT-I (cognitive behavioural therapy for insomnia) on sleep onset latency, total sleep time, subjective sleep quality, and daytime sleepiness: study protocol for a parallel group randomised controlled trial with online therapy groups of seven sessions each

Tanja Grünberger, Christopher Höhn, Manuel Schabus, Anton-Rupert Laireiter

Design and rationale for a randomized, open-label, parallel clinical trial evaluating major adverse cardiovascular events (pharmacological treatment versus diet control) in patients with high-normal blood pressure: the PRINT-TAHA9 trial

Armin Attar, Seyed Alireza Mirhosseini, Roham Borazjani, Mehrab Sayadi, Mahsa Ahadi, MohammadJavad Zibaeenezhad, Iman Razeghian-Jahromi, Nader Parsa

  • Open Access
  • Suicide
  • Study protocol

Randomised controlled trial of a psychotherapeutic intervention to improve quality of life and other outcomes in people who repeatedly self-harm: FReSH START study protocol

K. Farley, B. Copsey, A. Wright-Hughes, A. Farrin, C. Bojke, D. McMillan, C. D. Graham, R. Mattock, C. A. Brennan, C. Gates, A. Martin, A. Dowse, J. Horrocks, A. O. House, E. A. Guthrie

Intranasal administration of insulin on the incidence of postoperative delirium in middle-aged patients undergoing elective on-pump cardiac surgery (INIPOD-MOPS): a prospective double-blinded randomized control study protocol

Ming Yang, Guiying Yang, Tong Lu, Lei Cao, Cheng Xiao, Yan Liang, Jinping Ding, Xuetao Jiang, Wei Wang, Fang Chen, Zhiyong Du, Hong Li

A double-masked, sham-controlled trial of rose bengal photodynamic therapy for the treatment of fungal and acanthamoeba keratitis: Rose Bengal Electromagnetic Activation with Green Light for Infection Reduction (REAGIR) study

NV Prajna, P Lalitha, S Sharma, D de Freitas, A Höfling-Lima, N Varnado, S Abdelrahman, V Cavallino, BF Arnold, TM Lietman, J Rose-Nussbaumer

The effect of a behavioural intervention package on quality of life of pregnant women experiencing domestic violence: a randomised controlled trial

Meerambika Mahapatro, Sudeshna Roy, Poonam Nayar, Ashwini Jadhav, Suruchi Panchkaran, Divyanshu Srivastava, Sudha Prasad, Neera Dhar

  • Open Access
  • Update

Multicomponent family support intervention in intensive care units: statistical analysis plan for the cluster-randomized controlled FICUS trial

Stefanie von Felten, Miodrag Filipovic, Marie-Madlen Jeitziner, Lotte Verweij, Marco Riguzzi, Rahel Naef

  • Open Access
  • Study protocol

Effectiveness and cost-effectiveness of a community intervention in enhancing access to care and improving clinical outcomes for depression: a protocol for a cluster randomised controlled trial in India

Abhijit Nadkarni, Yashi Gandhi, Luanna Fernandes, Kedar Mirchandani, Shreyas Kamat, Helen A. Weiss, Daisy R. Singla, Richard Velleman, Chunling Lu, Urvita Bhatia, Bijayalaxmi Biswal, Miriam Sequeira, Ethel D’souza, Kedar Raikar, Vikram Patel

Cerebral blood flow and cognition after 3 months tadalafil treatment in small vessel disease (ETLAS-2): study protocol for a randomized controlled trial

Joakim Ölmestig, Kristian Nygaard Mortensen, Birgitte Fagerlund, Nadia Naveed, Mette Maria Nordling, Hanne Christensen, Helle Klingenberg Iversen, Mai Bang Poulsen, Hartwig Roman Siebner, Christina Kruuse

  • Open Access
  • Study protocol

Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): study protocol for a national implementation trial

Kathryn M. Yount, Daniel J. Whitaker, Xiangming Fang, Quach Thu Trang, Meghan Macaulay, Tran Hung Minh

The long-term efficacy and safety of balloon dilation eustachian tuboplasty combined with tympanostomy tube insertion for patients with otitis media with effusion: study protocol for a prospective randomized controlled trial

Peixia Wu, Xuejiao Cao, Ruiqi Zhang, Yaoqian Liu, Huawei Li, Wuqing Wang, Wenyan Li

  • Open Access
  • Research

Public perspective on potential treatment intervention harm in clinical trials—terminology and communication

Rachel Phillips, Dongquan Bi, Beatriz Goulão, Marie Miller, Malak El-Askary, Oluyemi Fagbemi, Curie Freeborn, Maria Giammetta, Noura El Masri, Peter Flockhart, Manos Kumar, Mike Melvin, Dianne Murray, Anthony Myhill, Laila Saeid, Shanice Thomas, Graeme MacLennan, Victoria Cornelius

Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial

Anna Kristensen-Alvarez, Mikkel Fode, Hein Vincent Stroomberg, Kurt Krøyer Nielsen, Albert Arch, Lars Birger Lönn, Mikkel Taudorf, Steven John Widecrantz, Andreas Røder

  • Open Access
  • Study protocol

SMSs as an alternative to provider-delivered care for unhealthy alcohol use: study protocol for Leseli, an open-label randomised controlled trial of mhGAP-Remote vs mhGAP-Standard in Lesotho

Jennifer M. Belus, Natalie E. Johnson, Grace H. Yoon, Nadine Tschumi, Malebanye Lerotholi, Irene Falgas-Bague, Tristan T. Lee, Pearl Letsoela, Jessica F. Magidson, Alain Amstutz, Niklaus D. Labhardt

  • Open Access
  • Study protocol

Promoting mental health and wellbeing among post-secondary students with the JoyPop™ app: study protocol for a randomized controlled trial

Angela MacIsaac, Vamika Mann, Elaine Toombs, Fred Schmidt, Janine V. Olthuis, Sherry H. Stewart, Amanda Newton, Arto Ohinmaa, Aislin R. Mushquash

Limited fasciectomy with versus without autologous adipose tissue grafting for treatment of Dupuytren’s contracture (REMEDY): study protocol for a multicentre randomised controlled trial

Elias T. Sawaya, Benjamin Sommier, Jean-Maxime Alet, Pierre-Thierry Piechaud, Florent Devinck, Erlé Weltzer, Youssouf Tanwin, Kinga Michalewska, Floris van Rooij, Mo Saffarini, Flore-Anne Lecoq

GnRH-a-based fertility-sparing treatment of atypical endometrial hyperplasia (AEH) and early endometrial carcinoma (EC) patients: a multicenter, open-label, randomized designed clinical trial protocol

Qian Liu, Huimei Zhou, Mei Yu, Dongyan Cao, Jiaxin Yang

  • Open Access
  • Commentary

Collecting and reporting adverse events in low-income settings—perspectives from vaccine trials in the Gambia

Andrew Ayi-Ashong Bruce, Ama-Onyebuchi Umesi, Adedapo Bashorun, Magnus Ochoge, Mohammed Yisa, Dolapo Obayemi-Ajiboye, Ahmed Futa, Anna Njie, Selasi Asase, Modou Bella Jallow, Larry Kotei, Lucy Affleck, Olubunmi Abiola Olubiyi, Lamin B. Jarju, Madi Kanyi, Baba Danso, Armel Zemsi, Ed Clarke

Effect of aerobic exercise program on neuropathic pain and quality of life in person with paraplegia: study protocol for a randomized controlled trial

Ankush Gera, Shefali Walia, Stuti Khanna, Garima Wadhwa

The effects of percutaneous branch pulmonary artery interventions in biventricular congenital heart disease: study protocol for a randomized controlled Dutch multicenter interventional trial

R. S. Joosen, M. Voskuil, T. B. Krasemann, N. A. Blom, G. J. Krings, J. M. P. J. Breur

No genetic causal association between human papillomavirus and lung cancer risk: a bidirectional two-sample Mendelian randomization analysis

Yizhuo Chen, Ziqing Xu, Zhouqi Zhang, Xin Wang, Ming Dong

  • Open Access
  • Malaria
  • Study protocol

Anti-infectivity efficacy and pharmacokinetics of WHO recommended single low-dose primaquine in children with acute Plasmodium falciparum in Burkina Faso: study protocol

Alphonse Ouédraogo, Julie Nguyen Ngoc Pouplin, Mavuto Mukaka, Thoopmanee Kaendiao, Andrea Ruecker, Pascal Millet, Thibaut Vallet, Fabrice Ruiz, Sodiomon B. Sirima, Walter R. Taylor

Postoperative physical rehabilitation in the elderly patient after emergency surgery. Influence on functional, cognitive and quality of live recovery: study protocol for a randomized clinical trial

Irene Esquiroz Lizaur , Fabricio Zambom-Ferraresi, Fabiola Zambom-Ferraresi, Iranzu Ollo-Martínez, Antón De la Casa-Marín, Nicolás Martínez-Velilla, Ana Recreo Baquedano, Arkaitz Galbete Jimenez, Gregorio González Alvarez, María Concepción Yarnoz Irazabal, Inés Eguaras Córdoba

Effect of perioperative sigh ventilation on postoperative hypoxemia and pulmonary complications after on-pump cardiac surgery (E-SIGHT): study protocol for a randomized controlled trial

Zhichang Wang, Qiyu Cheng, Shenglun Huang, Jie Sun, Jingyuan Xu, Jianfeng Xie, Hailong Cao, Fengmei Guo

Update to the study protocol: minimisation of dialysis risk in hospital patients with chronic kidney disease (MinDial): a multicentre, stepped-wedge, cluster-randomised controlled trial

D. Stelzer, H. Binder, M. Glattacker, E. Graf, M. Hahn, M. Hollenbeck, K. Kaier, B. Kowall, N. Kuklik, G. Metzner, N. Mueller, L. Seiler, S. Stolpe, C. Blume

Evaluating fentanyl test strips as a harm reduction strategy in rural and urban counties: study protocol for a randomized controlled trial

Ashley Short Mejia, Gary A. Smith, Soledad A. Fernandez, Bridget Freisthler, Christine Grella, Nichole L. Michaels

Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial

K. Keywani, W. J. Eshuis, A. B. J. Borgstein, M. J. van Det, P. van Duijvendijk, B. van Etten, P. P. Grimminger, J. Heisterkamp, S. M. Lagarde, M. D. P. Luyer, S. R. Markar, S. L. Meijer, J. P. E. N. Pierie, F. Roviello, J. P. Ruurda, J. W. van Sandick, M. Sosef, B. P. L. Witteman, W. O. de Steur, B. I. Lissenberg-Witte, M. I. van Berge Henegouwen, S. S. Gisbertz

  • Open Access
  • Bruxism
  • Study protocol

3D printed versus milled stabilization splints for the management of bruxism and temporomandibular disorders: study protocol for a randomized prospective single-blinded crossover trial

Kerstin Rabel, Jörg Lüchtenborg, Marie Linke, Felix Burkhardt, Anuschka J. Roesner, Julian Nold, Kirstin Vach, Siegbert Witkowski, Anna-Lena Hillebrecht, Benedikt C. Spies

Upadacitinib to improve anxiety in patients with adalimumab-treated psoriatic arthritis: study protocol for a randomized controlled trial

Junlan Liao, Ziyu Wang, Jianyong Zhang, Haibo Tan, Zhihao Zhang, Shan Zhang, Shasha Hu, Hongling Geng, Zhiying Zhan, Jiaxin Wei, Zhiling Li, Ertao Jia

Thromboprophylaxis in oesophageal cancer patients—a study protocol for a randomised, controlled trial (TOP-RCT)

Tua Gyldenholm, Nina Madsen, Niels Katballe, Daniel Willy Kjær, Thomas Decker Christensen, Anne-Mette Hvas

Effect of a soft exosuit on daily life gait performance in people with incomplete spinal cord injury: study protocol for a randomized controlled trial

L. Visch, B. E. Groen, A. C. H. Geurts, I. J. W. van Nes, N. L. W. Keijsers

  • Open Access
  • Methodology

Covariate-constrained randomization in cluster randomized 2 × 2 factorial trials: application to a diabetes prevention study

Juned Siddique, Zhehui Li, Matthew J. O’Brien

Formulation-based cognitive behavioral therapy compared to an active control and a waitlist in adult inmates with ADHD: study protocol for a randomized controlled trial

Carlos López-Pinar, Sonia Martínez-Sanchís, Enrique Carbonell-Vayà, Jose Martínez-Raga, Wolfgang Retz

SPIDOL study protocol for the assessment of intrathecal ziconotide antalgic efficacy for severe refractory neuropathic pain due to spinal cord lesions

Andrei Brinzeu, Julien Berthiller, Nathalie Perreton, Fabien Subtil, Caroline Gervaise, Jacques Luaute, Patrick Mertens, Michel Lanteri-Minet, Brigitte Perrouin Verbe, Bechir Jarraya, Philippe Menei, Jimmy Voirin, Jean-Marie Regis, Kevin Buffenoir, Marc Lefort, Denys Fontaine, Jean Luc Barat

  • Open Access
  • Commentary

Using online methods to recruit participants into mental health clinical trials: considerations and recommendations from the RE-MIND study

Mais Iflaifel, Charlotte L. Hall, Heidi R. Green, Andrew Willis, Stefan Rennick-Egglestone, Edmund Juszczak, Mark Townsend, Jennifer Martin, Kirsty Sprange

Effectiveness of structured, multidisciplinary long-term care for pediatric cancer survivors: protocol of the multicenter, randomized-controlled AELKI study

Hannah Schmidt, Katja Baust, Gabriele Calaminus, Lisa Hohls, Katharina Tetzner, Nicole Griech, Henrike Haugke, Hannah Baltus, Susanne Elsner, Alexander Katalinic, Hera Becker, Chirine Cytera, Judith Gebauer, Ann-Kristin Kock-Schoppenhauer, Anke Neumann, Christian Denzer, Michael M. Schündeln, Jörg Faber, Conny Sattler, Michael C. Frühwald, Anja Borgmann-Staudt, Anke Barnbrock, Markus Metzler, Gabriele Escherich, Inke R. König, Ingo Menrath, Thorsten Langer

A phase II trial examining the safety and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) for people living with multiple sclerosis

Natasha Stevens, Chigozie Ezegbe, Valery Fuh-Ngwa, Kalina Makowiecki, Amin Zarghami, Phuong Tram Nguyen, Julie Sansom, Kate Smith, Laura L. Laslett, Meg Denham, Carlie L. Cullen, Michael H. Barnett, Mark R. Hinder, Monique Breslin, Kaylene M. Young, Bruce V. Taylor

  • Open Access
  • Study protocol

The influence of different intensity of Tan Tui exercises on the posture control of students in the Tai Chi Elective Course: protocol for a randomized controlled trial

Youhua Li, Zemin Yu, Huaixu Li, Shanyuan Ma, Wenjing Zhang

  • Open Access
  • Correction

Correction: The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials

Robin Chatters, Olivia Hawksworth, Steven Julious, Andrew Cook

SAME day amBulatory Appendectomy (SAMBA): a multicenter, prospective, randomized clinical trial protocol

Catherine Arvieux, Fatah Tidadini, Sandrine Barbois, Eric Fontas, Michel Carles, Victor Gridel, Jean-Christophe Orban, Jean-Louis Quesada, Alison Foote, Coralie Cruzel, Sabine Anthony, Julie Bulsei, Céline Hivelin, Damien Massalou

  • Open Access
  • Correction

Correction: Every Newborn-Reach Up Early Education Intervention for All Children (EN-REACH)- a parent group intervention for school readiness in Bangladesh, Nepal, and Tanzania: study protocol for a cluster randomized controlled trial

Mohammad Abdul Awal Miah, Jaya Chandna, Rejina Gurung, Nahya Salim Masoud, Proma Paul, Shafqul Ameen, Omkar Basnet, Mustafa Miraji, Cally Tann, Ismat Ara Mili, A K M Tanvir Hossain, Atique Iqbal Chowdhury, Asraful Alam, Kate Mackinnon Milner, Shams El Arifeen, Ashish KC, Karim Manji, Paul Lynch, Joy E. Lawn, Jena Derakhshani Hamadani

  • Open Access
  • Study protocol

Protocol of a randomized controlled trial on the effectiveness and cost-effectiveness of the PLACES intervention: a supported employment intervention aimed at enhancing work participation of unemployed and/or work-disabled cancer survivors

F. van Ommen, S. F. A. Duijts, P. Coenen, S. O. Dalton, A. Kliffen, R. van Hummel, A. G. E. M. de Boer, M. A. Greidanus

Developing a process for assessing the safety of a digital mental health intervention and gaining regulatory approval: a case study and academic’s guide

Rayan Taher, Charlotte L. Hall, Aislinn D Gomez Bergin, Neha Gupta, Clare Heaysman, Pamela Jacobsen, Thomas Kabir, Nayan Kalnad, Jeroen Keppens, Che-Wei Hsu, Philip McGuire, Emmanuelle Peters, Sukhi Shergill, Daniel Stahl, Ben Wensley Stock, Jenny Yiend

  • Open Access
  • Research

The effectiveness of Bio-Min toothpaste in the management of white spot lesions: a randomised control trial

Ama Johal, Aoife Keogh, Honieh Bolooki

Mothers and Babies Virtual Group (MBVG) for perinatal Latina women: study protocol for a hybrid type-1 effectiveness-implementation randomized controlled trial

Rheanna Platt, Sarah Polk, Alinne Z. Barrera, Sandraluz Lara-Cinisomo, Lisa R. Hirschhorn, Andrea K. Graham, Rashelle J. Musci, Jaime Hamil, Diane Echavarria, Lindsay Cooper, S. Darius Tandon

MultiSCRIPT-Cycle 1—a pragmatic trial embedded within the Swiss Multiple Sclerosis Cohort (SMSC) on neurofilament light chain monitoring to inform personalized treatment decisions in multiple sclerosis: a study protocol for a randomized clinical trial

Perrine Janiaud, Chiara Zecca, Anke Salmen, Pascal Benkert, Sabine Schädelin, Annette Orleth, Lilian Demuth, Aleksandra Maleska Maceski, Cristina Granziera, Johanna Oechtering, David Leppert, Tobias Derfuss, Lutz Achtnichts, Oliver Findling, Patrick Roth, Patrice Lalive, Marjolaine Uginet, Stefanie Müller, Caroline Pot, Robert Hoepner, Giulio Disanto, Claudio Gobbi, Leila Rooshenas, Matthias Schwenkglenks, Mark J. Lambiris, Ludwig Kappos, Jens Kuhle, Özgür Yaldizli, Lars G. Hemkens

  • Open Access
  • Research

Design considerations for Factorial Adaptive Multi-Arm Multi-Stage (FAST) clinical trials

Jonathan Beall, Jordan Elm, Matthew W. Semler, Li Wang, Todd Rice, Hooman Kamel, William Mack, Akshitkumar M. Mistry

Reducing pain by improving brain and muscle activity with motor cortical neuromodulation in women with interstitial cystitis/bladder pain syndrome: a study protocol for a randomized controlled trial

Eileen V. Johnson, Molly Bachmann, Moheb S. Yani, Sandrah P. Eckel, Giselle I. Garcia, Larissa V. Rodriguez, Jason J. Kutch

  • Open Access
  • Methodology

Development of the Better Research Interactions for Every Family (BRIEF) intervention to support recruitment for neonatal clinical trials: an intervention mapping guided approach

Elliott Mark Weiss, Megan M. Gray, Linda K. Ko, Devan M. Duenas, Ellie Oslin, Stephanie A. Kraft

A multicomponent personalized prevention program in the primary care setting: a randomized clinical trial in older people with noncommunicable chronic diseases (Primacare_P3 study)

Alberto Pilotto, Marina Barbagelata, Eleonora Lacorte, Carlo Custodero, Nicola Veronese, Valentina Maione, Wanda Morganti, Emanuele Seminerio, Paola Piscopo, Elisa Fabrizi, Patrizia Lorenzini, Elena Carbone, Pierangelo Lora Aprile, Vincenzo Solfrizzi, Mario Barbagallo, Nicola Vanacore, Maddalena Pettenati, Alberto Ferri, Cesare Massone, Alessandra Argusti, Simone Canepa, Massimiliano Gresonti, Marco De Benedetto, Carlo Berutti-Bergotto, Antonio Mazzocca, Rosa Rita Paparella, Dragana Nikolic, Sharon Di Vendra, Roberto Rivabene, Alessio Crestini, Paola Fortini, Lucia Conti, Francesco Della Gatta

  • Open Access
  • Study protocol

Cooperation across healthcare service levels for medication reviews in older people with polypharmacy admitted to a municipal in-patient acute care unit (The COOP II Study): study protocol for a randomized controlled trial

Leonor Roa Santervas, Torgeir Bruun Wyller, Eva Skovlund, Janicke Liaaen Jensen, Katrine Gahre Fjeld, Lene Hystad Hove, Ingrid Beate Ringstad, Lena Bugge Nordberg, Kristin Mæland Mellingen, Espen Saxhaug Kristoffersen, Rita Romskaug

Effect of non-steroidal anti-inflammatory drugs on the management of postoperative pain after cardiac surgery: a multicenter, randomized, controlled, double-blind trial (KETOPAIN Study)

Pierre Huette, Mouhamed Moussa, Momar Diouf, Thomas Lefebvre, Guillaume Bayart, Mathieu Guilbart, Christophe Viart, Guillaume Haye, Stéphane Bar, Thierry Caus, Sandrine Soriot-Thomas, Sophie Boddaert, Hamza Yahia Alshatri, Paul Tarpin, Ottilie Fumery, Christophe Beyls, Hervé Dupont, Yazine Mahjoub, Emmanuel Besnier, Osama Abou-Arab

  • Open Access
  • Commentary

Overcoming the barriers to better evidence generation from clinical trials

Lindsay Kehoe, Trevan Locke, Mark McClellan, Martin Landray, Adrian Hernandez, Sally Okun

Synbiotics in patients at risk for spontaneous preterm birth: protocol for a multi-centre, double-blind, randomised placebo-controlled trial (PRIORI)

Katrien Nulens, Els Papy, Katrien Tartaglia, Isabelle Dehaene, Hilde Logghe, Joachim Van Keirsbilck, Frédéric Chantraine, Veronique Masson, Eva Simoens, Willem Gysemans, Liesbeth Bruckers, Sarah Lebeer, Camille Nina Allonsius, Eline Oerlemans, Deborah Steensels, Marijke Reynders, Dirk Timmerman, Roland Devlieger, Caroline Van Holsbeke

Effect of extracorporeal shock wave combined with autologous platelet-rich plasma injection on rotator cuff calcific tendinitis: study protocol for a randomized controlled trial

Xiaofang Wang, Shuya Jia, Jianhui Cui, Xiali Xue, Zhiguang Tian

Effectiveness of long-term low-dose aspirin in the prevention of gastric cancer after Helicobacter pylori eradication: study design and rationale of Ardabil gastric cancer randomized placebo-controlled prevention trial (AGCPT)

Farhad Pourfarzi, Mohammad-Mahdi Rashidi, Abbas Yazdanbod, Ali Nemati, Hadi Peeri Dogaheh, Elnaz Faghfuri, Fateme Gorgani, Saied Hosseini-Asl, Bijan Zamani, Sanaz Pourfarzi, Arash Etemadi, Fateme Shafighian, Negar Rezaei, Hossein Poustchi, Reza Malekzadeh, Alireza Sadjadi

High-frequency magnetic paired associated stimulation promotes motor function recovery in ischemic stroke patients: a study protocol for single-center, sham stimulation randomized controlled trials (H2MPAS)

Guangyue Zhu, Shuping Wang, Guodong Zhang, Yu Zhang, Zhexue Huang, Xiaoshun Tan, Yuhui Chen, Hui Sun, Dongsheng Xu

Rapid normalization of vitamin D deficiency in PICU (VITdALIZE-KIDS): study protocol for a phase III, multicenter randomized controlled trial

Katie O’Hearn, Kusum Menon, Lisa Albrecht, Karin Amrein, Philip Britz-McKibbin, Florence Cayouette, Karen Choong, Jennifer Ruth Foster, Dean A. Fergusson, Alejandro Floh, Patricia Fontela, Pavel Geier, Elaine Gilfoyle, Gonzalo Garcia Guerra, Anna Gunz, Erick Helmeczi, Ali Khamessan, Ari R. Joffe, Laurie Lee, Lauralyn McIntyre, Srinivas Murthy, Simon J. Parsons, Tim Ramsay, Lindsay Ryerson, Marisa Tucci, Dayre McNally

Implementing a pragmatic randomised controlled trial in a humanitarian setting: lessons learned from the TISA trial

D. S. N’Diaye, S. Frison, M. Ba, M. L. Lê, A. E. Cabo, F. Siroma, A. Devort, C. MacLeod, J. Lapègue, M. Seye, A. B. Traoré, T. Cerveau, D. Léger, K. Gallandat, Y. Gnokane, A. Vargas Brizuela, S. Stern, L. Braun, O. Cumming

Chronic stress and functional health in older adults with concerns about falling: a study protocol of a randomized controlled trial with multicomponent exercise intervention (FEARFALL)

Sabine Britting, Robert Kob, Anja Görlitz, Cornel C. Sieber, Ellen Freiberger, Nicolas Rohleder

Correction: SAME day amBulatory Appendectomy (SAMBA): a multicenter, prospective, randomized clinical trial protocol

Catherine Arvieux, Fatah Tidadini, Sandrine Barbois, Eric Fontas, Michel Carles, Victor Gridel, Jean-Christophe Orban, Jean-Louis Quesada, Alison Foote, Coralie Cruzel, Sabine Anthony, Julie Bulsei, Céline Hivelin, Damien Massalou

A multi-center, double-blind, placebo-controlled, randomized, parallel-group, non-inferiority study to compare the efficacy of goal-directed tranexamic acid administration based on viscoelastic test versus preemptive tranexamic acid administration on postoperative bleeding in cardiovascular surgery (GDT trial)

Jae-Sik Nam, Chung-Sik Oh, Ji-Yoon Kim, Dae-Kee Choi, Ah Ran Oh, Jungchan Park, Jong-Hwan Lee, Sung-Cheol Yun, Kyeng Whan Kim, Min Uk Jang, Tae-Yop Kim, In-Cheol Choi

  • Open Access
  • Research

Recommendations for developing accessible patient information leaflets for clinical trials to address English language literacy as a barrier to research participation

Vikki Wylde, Sharon Brennan, Emma Johnson, Kirsty Roberts, Andrew D. Beswick, Catherine Jameson

Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study protocol for a single center, prospective, cluster randomized trial

Melissa M. Cushing, Tobias Cohen, Meghann M. Fitzgerald, Sophie Rand, Abraham Sinfort, Dennis Chen, Nadia Keltner, Sidney Ong, Priscilla Parra, Denden Benabdessadek, Alexandra Jimenez, Thorsten Haas, Christopher Lau, Natalia Ivascu Girardi, Robert A. DeSimone

Impact of oral azithromycin and intermittent preventive treatment with sulfadoxine-pyrimethamine regimen on child mortality in Sierra Leone: trial protocol for a randomised, two-arm, double-blinded, placebo-controlled clinical trial (ICARIA)

Kwabena Owusu-kyei, Haily Chen, Maureen Chileshe, Llorenç Quintó, Maya Sibley, Antía Figueroa-Romero, Mireia Llach, Máximo Ramírez, Andreu Bofill, Mohamed Samai, Clara Menéndez

The optimal antibiotic treatment duration for community-acquired pneumonia in adults diagnosed in general practice in Denmark (CAP-D): an open-label, pragmatic, randomised controlled trial

Eskild Johansen, Henrik Nielsen, David Gillespie, Rune Aabenhus, Malene Plejdrup Hansen

A custom tailored, evidence-based, theory-informed intervention for healthcare professionals to prevent burnout (LAGOM): study protocol for a pragmatic randomized controlled trial

Anna K. Koch, Marleen Schröter, Julia Berschick, Julia K. Schiele, Martin Bogdanski, Melanie Steinmetz, Wiebke Stritter, Andreas Voss, Georg Seifert, Christian S. Kessler

  • Open Access
  • Methodology

The OBS UK Dashboard: an interactive tool for representative trial site selection to facilitate equality and diversity in maternity research

Amy Elsmore, Tanvi Rai, Philip Pallmann, Julia Townson, Sarah Kotecha, Mairead Black, Julia Sanders, Rachel Collis, Peter Collins, Bala Karunakaran, Pensee Wu, Sarah Bell, William Parry-Smith

Efficacy of methylene blue in refractory septic shock: study protocol for a multicenter, randomized, placebo-controlled trial

Jinxin Jia, Jingjing Ji, Zhifeng Liu

A hybrid type II effectiveness-implementation trial of a positive emotion regulation intervention among people living with HIV engaged in Ryan White Medical Case Management: protocol and design for the ORCHID study

Casey D. Xavier Hall, Kristen Ethier, Peter Cummings, Angela Freeman, Katrin Bovbjerg, Jacqueline Bannon, Andrea Dakin, Fay Abujado, Nora Bouacha, Devan Derricotte, Lakethia Patterson, Lisa R. Hirschhorn, Alida Bouris, Judith T. Moskowitz

  • Open Access
  • Study protocol

OPTimising MEDicine information handover after Discharge (OPTMED-D): protocol for development of a multifaceted intervention and stepped wedge cluster randomised controlled trial

Laetitia Hattingh, Melissa T. Baysari, Holly Foot, Tin Fei Sim, Gerben Keijzers, Mark Morgan, Ian Scott, Richard Norman, Faith Yong, Barbara Mullan, Claire Jackson, Leslie E. Oldfield, Elizabeth Manias

  • Open Access
  • Update

Statistical analysis plan for the SOLUTIONS randomised controlled trial with internal pilot: Solution Focused Brief Therapy (SFBT) in 10–17 year olds presenting at police custody

Paul A. Thompson, Gwenllian Moody, Elinor Coulman, Eleri Owen-Jones, Faizan Patel, Kylie M. Gray, Richard P. Hastings, Andrea Longman, Fiona Lugg-Widger, Jeremy Segrott, Julia Badger, Samantha Flynn, Peter E. Langdon, Rebecca Playle

A comparison of efficacy of erector spinae plane block versus serratus anterior plane block plus subcostal transversus abdominus plane block for bariatric laparoscopic sleeve gastrectomy surgery: study protocol for a randomised clinical trial

Patrick N. Wiseman, Michaela Van der Walt, Michael O’Riordan, Kieran Brosnan, Mujeeb Shaikh, David Cosgrave

Role of the screening with coronary computed tomography angiography on lipid management and risk factors control in an asymptomatic Chinese population: a community-based, parallel-group, open-label, randomized clinical trial (RESPECT2)

Xiang Guo, Jianhua Li, Ying Zhu, Yanming Li, Jingzhou Jiang, Rui Zuo, Wei Xu, Junqing Ma, Chao Li, Jialuo Yang, Yuting Liu, Minjie Zhao, Di Tian, Xinran Wang, Jinwei Sun, Bingqian Wu, Conghong Wang, Pengfei Jiang, Jun Zhang, Jian Zhong, Changsheng Zhou, Dongna Yi, Xueqin Bao, Jun Cai, Yingqi Chen, Xiaoqing Cheng, Haowen Gong, Yongyue Wei, Yuxiu Liu, Long Jiang Zhang

  • Open Access
  • Research

Views of research ethics committee members on end-of-participation communications for trial participants who stop taking part: a cross-sectional survey study

William J. Cragg, Liam Bishop, Rachael Gilberts, Michael Gregg, Mary Mancini, Clara Martins de Barros

  • Open Access
  • Anxiety
  • Study protocol

Study protocol for a pragmatic randomised multiple baseline trial evaluating Knowledge Insight Tools (KIT), a cognitive behavioural therapy-informed school-based counselling intervention for children and young people in UK secondary schools with low mood and anxiety

Matthew Paul Constantinou, Jessica Stepanous, Suzet Tanya Lereya, Hannah Wilkinson, Sarah Golden, Jessica Deighton

Vitamin D combined with whole-body vibration training for the treatment of osteo-sarcopenia: study protocol for a randomized controlled trial

Wenxiong Li, Menghan Chen, Feifei Chen, Yanan Li, Yuan Zhong, Yu Lu, Kuaiqiang Zhang, Feng Yang

  • Open Access
  • Study protocol

Self-management support program delivered in the sub-acute phase after traumatic injury—study protocol for a pragmatic randomized controlled trial

Mari S. Rasmussen, Nada Andelic, Joanna Nordhagen Selj, Vilde Marie Danielsen, Marianne Løvstad, Emilie Isager Howe, Torgeir Hellstrøm, Helene L. Soberg, Cathrine Brunborg, Eline Aas, Håkon Moksnes, Unni Sveen, Christine Gaarder, Pål Aksel Næss, Eirik Helseth, Olav Røise, Mads Aarhus, Hege Prag Øra, John Andreas Bjørneboe, Silje Fure, Cecilie Røe, Christoph Schäfer, Paul B. Perrin, Juan Lu, Marie Elf, Hilde Margrethe Dahl, Fiona Jones, Jennie Ponsford, Linda Narvestad, Solveig L. Hauger

A multi-center, randomized, double-blind, sham-stimulation controlled study of transcranial magnetic stimulation with precision navigation for the treatment of multiple system atrophy

Jing Bai, Ya Bai, Xiaobing Li, Yaqian Mu, Xiaolong Sun, Bo Wang, Lei Shang, Zhengli Di, Wei Zhang, Jin Qiao, Rui Li, Xin Guo, Xinyao Liu, Yan Shi, Rui Li, Xuedong Liu

  • Open Access
  • Study protocol

Role of ultra-processed foods in modulating the effect of Mediterranean diet on human and planet health—study protocol of the PROMENADE randomized controlled trial

Monica Dinu, Donato Angelino, Cristian Del Bo’, Mauro Serafini, Francesco Sofi, Daniela Martini

  • Open Access
  • Study protocol

A single-center, double-blind, randomized, placebo-controlled, two-arm study to evaluate the safety and efficacy of once-weekly sirolimus (rapamycin) on muscle strength and endurance in older adults following a 13-week exercise program

Brad Stanfield, Matt Kaeberlein, Brian Leroux, Julie Jones, Ruth Lucas, Bruce Arroll

Secondary traumatization in refugee care—EMDR intervention for interpreters (STEIN): a study protocol for a quasi-randomized controlled trial

Irja Rzepka, David Kindermann, Hans-Christoph Friederich, Christoph Nikendei

Improving analysis of cognitive outcomes in cardiovascular trials using different statistical approaches

Shun Fu Lee, William Whiteley, Jackie Bosch, Laura Sherlock, Tali Cukierman-Yaffe, Martin O’Donnell, John W. Eikelboom, Hertzel C. Gerstein, Shrikant I. Bangdiwala, Graciela Muniz-Terrera

The impact of the COVID-19 pandemic and the changing landscape of CF on the cASPerCF trial: a real-world experience

Emily L. D. Chesshyre, Jacob D. Bradbury, Heather Cook, Francesca Rocchi, Kit Roes, Mark A. Turner, Roger Brüggemann, Adilia Warris

Correction: 4-Aminopyridine treatment for nerve injury resulting from radical retro-pubic prostatectomy: a single-center double-blind, randomized, placebo-controlled study

Ahmed Ghazi, Thomas L. Osinski, Changyong Feng, Andrea Horne, John Elfar

  • Open Access
  • Study protocol

The influence of simultaneous posterior colporrhaphy and perineoplasty on the efficiency and safety of mesh-augmented sacrospinal fixation (apical sling) in advanced POP repair

Rustam A. Shakhaliev, Andrey S. Shulgin, Nikita D. Kubin, Anton S. Kondratiev, Denis A. Suchkov, Sofia V. Neklasova, Dmitry D. Shkarupa

Effects of cognitive training under hypoxia on cognitive proficiency and neuroplasticity in remitted patients with mood disorders and healthy individuals: ALTIBRAIN study protocol for a randomized controlled trial

Kamilla Woznica Miskowiak, Viktoria Damgaard, Johanna Mariegaard Schandorff, Julian Macoveanu, Gitte Moos Knudsen, Annette Johansen, Pontus Plaven-Sigray, Claus Svarer, Caroline Bruun Fussing, Katrine Cramer, Martin Balslev Jørgensen, Lars Vedel Kessing, Hannelore Ehrenreich

Effects of aerobic training on cardiopulmonary fitness in patients with long COVID-19: a randomized controlled trial

Bingqing Bai, Mingyu Xu, Haofeng Zhou, Yingxue Liao, Fengyao Liu, Yuting Liu, Youyong Yuan, Qingshan Geng, Huan Ma

  • Open Access
  • Study protocol

Integrating the Memory Support Intervention into the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C): can improving memory for treatment in midlife and older adults improve patient outcomes? Study protocol for a randomized controlled trial

Anne E. Milner, Rafael Esteva Hache, Sophia Oliver, Laurel D. Sarfan, Julia M. Spencer, Ashby Cogan, Yimei Jiang, Emma R. Agnew, Garret G. Zieve, Jennifer L. Martin, Michelle R. Zeidler, Lu Dong, Joseph K. Carpenter, Joshua Varghese, Kiely Bol, Zia Bajwa, Caitlan A. Tighe, Allison G. Harvey

Calcium carbonate supplementation for the prevention of preeclampsia in high-risk pregnant women: a randomized clinical trial protocol

Cinara Rejane Viana Oliveira, Camille Lima Resende, Sabrina Joany Felizardo Neves, Alessandra Rezende Mesquita, Alfredo Dias de Oliveira-Filho

Nucleos(t)ide analogs to treat patients with positive hepatitis B virus deoxyribonucleic acid and normal alanine transaminase: protocol for an open-label single-center randomized parallel controlled trial

Jing Zhou, Fa-Da Wang, Lan-Qing Li, Yu-Jin Li, Shi-yan Wang, En-Qiang Chen

Utilising primary care electronic health records to deliver the ALABAMA randomised controlled trial of penicillin allergy assessment

Shadia Ahmed, Joanne Fielding, Catherine E. Porter, Kelsey F. Armitage, Marta Wanat, Chris Bates, Lazarina Engonidou, Robert M. West, Ly-Mee Yu, Ushma Galal, Philip Howard, Christopher C. Butler, Sinisa Savic, Jenny Boards, Sarah Tonkin-Crine, John Parry, Sue A. Pavitt, Jonathan T. Sandoe

Efficacy of a pharmacist care protocol to manage uncomplicated female cystitis in community pharmacies: an open-label, multicenter, randomized, controlled, cluster study: the PharmaCyst’ protocol

Arthur Piraux, Elsa Parot-Schinkel, Jean-François Hamel, Kurt Naber, Anne-Claire Oger, Alain Guilleminot, Aline Ramond-Roquin, Sébastien Faure

A randomized controlled non-inferiority trial of placebo versus macrolide antibiotics for Mycoplasma pneumoniae infection in children with community-acquired pneumonia: trial protocol for the MYTHIC Study

Patrick M. Meyer Sauteur, Michelle Seiler, Romy Tilen, Ester Osuna, Margarete von Wantoch, Semjon Sidorov, Christoph Aebi, Philipp Agyeman, Florence Barbey, Julia A. Bielicki, Ludivine Coulon, Beate Deubzer, Alex Donas, Ulrich Heininger, Kristina Keitel, Henrik Köhler, Lisa Kottanattu, Roger Lauener, Anita Niederer-Loher, Klara M. Posfay-Barbe, Maren Tomaske, Noémie Wagner, Petra Zimmermann, Franziska Zucol, Stefanie von Felten, Christoph Berger

Efficacy of behavioural parent training on attachment security in children with attention deficit hyperactivity disorder: a randomised controlled trial

Ayaka Ishii-Takahashi, Junko Hamada, Rio Yamaguchi, Takuya Kawahara, Takayo Mukai, Sudre Gustavo, Philip Shaw, Sato Ashida, Laura Koehly, Kengo Tsujimoto, Yuzu Yoshimaru, Yukiko Kano

  • Open Access
  • Study protocol

Digital communication between mothers and community health workers to support neonatal health (CHV-NEO): study protocol for a randomized controlled trial

Keshet Ronen, Lincoln C. Pothan, Violet Apondi, Felix A. Otieno, Daniel Mwakanema, Felix O. Otieno, Lusi Osborn, Julia C. Dettinger, Priyanka Shrestha, Helena Manguerra, Ferdinand Mukumbang, Millicent Masinde, Evelyn Waweru, Mercy Amulele, Christine Were, Beatrice Wasunna, Grace John-Stewart, Bryan Weiner, Arianna Rubin Means, Barbra A. Richardson, Anna B. Hedstrom, Jennifer A. Unger, John Kinuthia

  • Open Access
  • Review

A compound analysis of medical device clinical trials registered in Africa on clinicaltrials.gov

Brian Matovu, Mercy Takuwa, Charles Norman Mpaata, Noah Kiwanuka, Julius Mugaga, Racheal Patricia Nalwoga, Success Kamuhanda, Paula Kworekwa, Benedict Mulindwa, George William Jjuuko, Maria Klara Wolters, Marc P. Y. Desmulliez, Robert T. Ssekitoleko

DepActive: study protocol for a randomised controlled multicentre trial of telephone-delivered behavioural activation for the treatment of depression in older adults in primary care

Elin Byström, Björn Wennlöf, Inger Johansson, Lena Lönnberg, Marina Arkkukangas, Johnny Pellas, Mattias Damberg

The effect of MIND diet on sleep status, anxiety, depression, and cardiometabolic indices in obese diabetic women with insomnia: study protocol for a randomized controlled clinical trial {1}

Mona Golmohammadi, Vahideh Ebrahimzadeh Attari, Yahya Salimi, Seyed Mostafa Nachvak, Mehnoosh Samadi

Evaluating the effectiveness of Smoke-Free Home SafeCare, an integrated intervention, among families at risk for secondhand smoke exposure and child maltreatment in the United States: a study protocol for a hybrid type 1 trial

Elizabeth W. Perry, Shannon Self-Brown, Kaitlyn Koontz, Regine Haardörfer, Daniel J. Whitaker, Claire A. Spears, Jidong Huang, Michelle Kegler

  • Open Access
  • Study protocol

Design and rationale for an empirical investigation of the resource use and costs of investigator-initiated randomized trials in Switzerland, the UK, and Germany

Alexandra Griessbach, Benjamin Speich, Gilles Dutilh, Shaun Treweek, Matthias Schwenkglenks, Matthias Briel

Protocol for a randomized controlled trial: exercise-priming of CBT for depression (the CBT+ trial)

Jacob D. Meyer, Shania J. E. Kelly, John M. Gidley, Jeni E. Lansing, Seana L. Smith, Sydney L. Churchill, Emily B. K. Thomas, Simon B. Goldberg, Heather C. Abercrombie, Thomas A. Murray, Nathaniel G. Wade

Effects and mechanisms of supramaximal high-intensity interval training on extrapulmonary manifestations in people with and without chronic obstructive pulmonary disease (COPD-HIIT): study protocol for a multi-centre, randomized controlled trial

Johan Jakobsson, Chris Burtin, Mattias Hedlund, Carl-Johan Boraxbekk, Jonas Westman, Nina Karalija, Per Stål, Thomas Sandström, David Ruttens, Harry R. Gosker, Jana De Brandt, André Nyberg

  • Open Access
  • Research

Consideration of factors of low accrual and methods for setting appropriate accrual periods: Japan Clinical Oncology Group study

Keita Sasaki, Junki Mizusawa, Hiroko Bando, Kenichi Nakamura, Tomoko Kataoka, Hiroshi Katayama, Haruhiko Fukuda, Hisato Hara

Investigating the effects of co-supplementation with alpha-linolenic acid and L-carnitine on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life in women with migraine: a protocol for a randomized, triple-blind, placebo-controlled trial

Sahar Golpour-hamedani, Mohammad Bagherniy, Fariborz Khorvash, Awat Feizi, Manoj Sharma, Gholamreza Askari

Effects of home disease management strategies based on the dyadic illness management theory on elderly patients with chronic heart failure and informal caregivers’ physical and psychological outcomes: protocol of a randomized controlled trial

Yaoyao Hu, Lu Yu, Lingyun Zhu, Li Li, Xiaojing Li, Xiaoyan Wang, Taihua Zhou, Danfeng GU

Concussion Health Improvement Program (CHIP): study protocol for a randomized controlled optimization trial for youth with persistent post-concussive symptoms

Carolyn A. McCarty, Tayler Hennings, Chuan Zhou, Emily F. Law, Douglas Zatzick, Sara P. D. Chrisman

A multicentric, randomized, controlled clinical trial to study the impact of bedside model-informed precision dosing of vancomycin in critically ill children—BENEFICIAL trial

Pieter A. De Cock, Roos Colman, Anca Amza, Peter De Paepe, Hans De Pla, Lieselot Vanlanduyt, Dimitri Van der Linden, Petra Schelstraete, Filip Cools, Alexander Clarysse, Phebe Debouver, Dominique Biarent, Daphne Vania Vens, Anne Smits, Valerie Godart, Sophie Vanhaesebrouck, Evelyn Dhont, Victoria Bordon, Reiner Mauel, Jutte Van Der Werff Ten Bosch, Marleen Renard, Franciscus Derriks, Olivier Danhaive, Fiammetta Piersigilli, Houtekie Laurent, An van Damme, Lidvine Boland, Koenraad Smets, Alexandra Zecic, Linde Goossens, Kris De Coen, Annelies Keymeulen, Lara Garabedian, Julie De Meulemeester, Naessens Pauline, Tom Schepens, Emma Beel, Jef Willems, Annick de Jaeger, Ann Verrijckt, Bram De Wilde, Tiene Bauters, Nele Clottens, Sarah Mertens, Fleur Camfermann, Michael Sonnaert, Julie Lefevere, Barbara De Bisschop, Floortje Krechting, Lissa De Potter, James d’Haese, Marit Sijmons, Tine Francois, Xavier Berette-Piccoli, Shancy Rooze, Alfredo Vicinanza, Vanessa Guy Viterbo, Montserrat Sierra Colomina, Laura Slegers, Zoe Vander Elst, Anneleen Dereymaker, An Eerdekens, Liesbeth Thewissen, Maissa Rayyan, Laurien Vanbuggenhout, Marie Julie Debuf, Sarah Verbeeck, Karlijn van Damme, Anne Uyttebroeck, Veerle Labarque, Heidi Segers, Katrien Cosaert, Lotte Vander Elst, Eva Vanlaer, Isabelle Ceuterick, Olga Chatzis, Matthieu Deltombe, Bastien Tossens, Arnaud Nevraumont, Louise Guillaume, Martin Vanderdonck, Meryem Benamour, Mohammad Panahandeh, Veerle Mondelaers, Leen Willems, Leentje Peetermans, Astrid Haenecour, Maëlle de Ville de Goyet, Bénédicte Brichard, Manon Le Roux, Evelien Snauwaert, Charlotte Clauwaert, Hanife Kokur, Stefanie De Buyser

  • Open Access
  • Study protocol

Caregivers on point: a randomized treatment–control prevention trial for foster and kinship caregivers to reduce behavior challenges among children in foster care

Sarah J. Beal, Cynthia Zion, Constance A. Mara, Meera A. Patel, Amie F. Bettencourt, Susan M. Breitenstein, Lisa M. Vaughn, Mary V. Greiner, Robert T. Ammerman

A randomized controlled trial of a “Small Changes” behavioral weight loss treatment delivered in cardiac rehabilitation for patients with atrial fibrillation and obesity: study protocol for the BE-WEL in CR-AF study

Tamara M. Williamson, Codie R. Rouleau, Stephen B. Wilton, A. Braiden Valdarchi, Chelsea Moran, Stuti Patel, Lesley Lutes, Sandeep G. Aggarwal, Ross Arena, Tavis S. Campbell

Health dialogue intervention versus opportunistic screening in primary care for type 2 diabetes and cardiovascular disease prevention in settings with low socioeconomic status (DETECT): study protocol for a pragmatic cluster-randomized trial

Marcel Ballin, Moa Backman Enelius, Samira Dini, Maria Rosaria Galanti, Maria Hagströmer, Emelie Heintz, Anton Lager, Antonio Ponce de Leon, Lena Lundh, Camilla Nystrand, Christina Walldin, Hanna Augustsson

Why were so few randomized trials of public health and social measures conducted during the COVID-19 pandemic? The Norwegian experience

Atle Fretheim, Petter Elstrøm, Cathinka Halle Julin, Unni Gopinathan, Ingeborg Hess Elgersma, Runar Barstad Solberg, Arnfinn Helleve

  • Open Access
  • Anxiety
  • Study protocol