Fedratinib combined with ropeginterferon alfa-2b in patients with myelofibrosis (FEDORA): study protocol for a multicentre, open-label, Bayesian phase II trial by Graham McIlroy, Charlotte Gaskell, Aimee Jackson, Emily Yafai, Rachel Tasker, Catherine Thomas, Sonia Fox, Rebecca Boucher, Fitsum Ghebretinsea, Claire Harrison, Adam J. Mead, Mary Frances McMullin

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Rationale and design of the CardioMEMS Post‐Market Multinational Clinical Study: COAST by Martin R. Cowie, Pascal deGroote, Scott McKenzie, Marie‐Elena Brett, Philip B. Adamson, the CardioMEMS Post‐Market Study Investigators

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Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma: A randomized, double-blind, placebo-controlled trial by Meiyu Lyu, Yi Yang, Jinlian Liu, Wenting Fei, Min Fu, Yunting Hong, Hongguo Rong, Chun Wang, Linyuan Wang, Jianjun Zhang

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Perspectives of Women with Breast Cancer and Healthcare Providers Participating in an Adherence-Enhancing Program for Adjuvant Endocrine Therapy: A Qualitative Study by Véronique Turcotte, Laurence Guillaumie, Martine Lemay, Anne Dionne, Julie Lemieux, Angéline Labbé, Carolyn Gotay, Line Guénette, Sophie Lauzier

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Safety and efficacy of oral cancer vaccine B440 in patients with PD-1/PD-L1 inhibitor-resistant advanced urothelial cancer: a study protocol for a phase 1 multicenter, open-label,... by Junya Furukawa, Yasumasa Kakei, Sae Murakami, Hiroshi Kita, Hideto Ueki, Takuto Hara, Jun Teishima, Nobuyuki Hinata, Hideaki Miyake, Masato Fujisawa, Toshiro Shirakawa

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Levilactobacillus brevis CD2 as a multifaceted probiotic to preserve oral health: results of a double-blind, randomized, placebo-controlled trial in healthy adults by Serena Altamura, Francesca Lombardi, Francesca Rosaria Augello, Antonella Barone, Mario Giannoni, Benedetta Cinque, Davide Pietropaoli

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Lentivirus‐mediated gene therapy for Fabry disease: 5‐year End‐of‐Study results from the Canadian FACTs trial by Aneal Khan, Dwayne L. Barber, William M. McKillop, C. Anthony Rupar, Christiane Auray‐Blais, Graeme Fraser, Daniel H. Fowler, Alexandra Berger, Ronan Foley, Armand Keating, Michael L. West, Jeffrey A. Medin

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Efficacy and safety of intermittent fasting for type 2 diabetes mellitus: A systematic review and meta-analysis of randomized trials by Joshua Chadwick, Lavanya Ayyasamy, Madhanraj Kalyanasundaram, Ganeshkumar Parasuraman, Bhavani Shankara Bagepally, Jeyashree Kathiresan, Lokesh Shanmugam

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Efficacy and safety of SHR8554 on postoperative pain in subjects with moderate to severe acute pain following orthopedic surgery: A multicenter, randomized, double-blind, dose-expl... by Yanhua Zhao, Zhisheng Lu, Xuesong Song, Haihui Xie, Xungang Xiao, Guonian Wang, Qi Zhou, Qingmei Zhang, Liang Liu, Zhijian Lan, Ning Bai, Haiyan Wang, Zhihao Pan, Liang Dong, Xianzhong Lin, Gang Chen, Qinghui Wang, Jiangtao Dong, Jia Deng, Yongshan Nan, Jiaqiang Zhang, Xiaohua Zhou, Yanjuan Huang, Yongquan Chen, Huanzhong He, Ye Yang, Dengpan Yao, Jintai Jia, Shuan Jin, Yafeng Zhang, Zhonghui Luo, Jiangang Li, Linzhong Zhang, Fang Wang, Juehua Jing, Jiang Zhu, Lin Li, Guangda Wang, Huajing Guo, Qiang Wang, Diansan Su, Weifeng Yu, Xiyao Gu

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Probiotics supplementation for management of type II diabetes risk factors in adults with polycystic ovarian syndrome: a meta-analysis of randomized clinical trial by Chengcheng Zhang, Yingyue Sheng, Jinchi Jiang, Yuzheng Xue, Leilei Yu, Fengwei Tian, Jianxin Zhao, Hao Zhang, Jian Jin, Qixiao Zhai

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Decentralized clinical trials are better for the participants and for the planet: the case study of a double-blind randomized controlled trial in Singapore (PROMOTE study) by Lisa R. Fries, Nadia Khaled, Ivan Viveros Santos, Elvira Suniega-Tolentino, Motshewa Sesing, Melissa P. S. Toh, Chui Yuen Yang, Shiao Yng Chan, Shiao Yng Chan, Sara Colombo Mottaz

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Efficacy and safety of non-invasive low-frequency tibial nerve stimulator in overactive bladder by Zhipeng Zhang, Mengzhu Liu, Yangyun Wang, Peng Wu, Yiping Zhu, Bangmin Han, Zhihui Xu, Xudong Li, Chaoliang Shi, Jing Zhang, Deyi Luo, Guowei Shi, Yaoguang Zhang

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Emulating a randomized clinical trial with real-world data to evaluate the effect of antidepressant use in PTSD patients with high suicide risk by Oshin Miranda, Xiguang Qi, M. Daniel Brannock, Ryan Whitworth, Thomas Kosten, Neal David Ryan, Gretchen L. Haas, Gretchen L. Haas, Gretchen L. Haas, Levent Kirisci, LiRong Wang

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Can home care work be organized to promote musculoskeletal health for workers? Results from the GoldiCare cluster randomized controlled trial by Fredrik Klæboe Lohne, Marius Steiro Fimland, Javier Palarea-Albaladejo, Svend Erik Mathiassen, Andreas Holtermann, Skender Redzovic

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Efficacy of Antibiotic Versus Probiotics as Adjuncts to Mechanical Debridement for the Treatment of Peri-Implant Mucositis by Sindhu Sudhakar Kumararama, Manali Patil, Bhavna Jha Kukreja, Manjiri Salkar, Shikha Verma, Naina Pattnaik, Lalit Patil

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A clinical study of the immunogenicity and protective potency of a live recombinant GamLPV vaccine for intranasal use for the prevention of whooping cough in adult volunteers by Alevtina A. Lidzhieva, Alisa Yu. Medkova, Sergey V. Kulikov, Ludmila N. Sinyashina, Rezida A. Sioundioukova, Andrey P. Markov, Aleksey B. Verveda, Natalia E. Abaeva, Irina N. Chernyshova, Marina V. Gavrilova, Kristina K. Bushkova, Ilya N. Dyakov, Gennady I. Karataev

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Describing randomization in trials included in systematic reviews in orthopaedic surgery by Matthew Tang, Kimberley K. Lun, Adriane M. Lewin, Ian A. Harris

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Patient and public involvement in the design and protocol development for a platform randomised trial to evaluate diagnostic tests to optimise antimicrobial therapy (PROTECT) [vers... by Sammy Ainsworth, Cherry-Ann Waldron, Sarah Jones, Julie Carman, Martina Svobodova, Graham Prestwich, Margaret Ogden, Melanie Gager, Liza Keating

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Multicenter Randomized Clinical Trial of Brief Psychotherapy versus Usual Treatment for Common Mental Disorders in Adults by Marco A. Luengo-Castro, Javier Fernández-Méndez, José M. García-Montes, Pedro J. Caunedo-Riesco, Juan M. García-Haro, Begoña Braña-Menéndez, Dolores González-Díaz, Andrés Cabero-Álvarez, Marcelino Cuesta-Izquierdo

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Statistical analysis plan for the LAST ACT clinical trial; a Leukotriene A4 hydrolase Stratified non-inferiority Trial of Adjunctive Corticosteroids for HIV-negative adults with Tu... by Joseph Donovan, Dong Huu Khanh Trinh, Ronald B. Geskus, Marcel Wolbers, Guy E. Thwaites, Nguyen Thuy Thuong Thuong, Le Thanh Hoang Nhat

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