Ausgabe 1/2024
Inhalt (286 Artikel)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The clinical trial activation process: a case study of an Italian public hospital
Carolina Pelazza, Marta Betti, Francesca Marengo, Annalisa Roveta, Antonio Maconi
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
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
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
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
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
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
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
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
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
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
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