Safety, Tolerability, and Pharmacokinetics of NIM‐1324 an Oral LANCL2 Agonist in a Randomized, Double‐Blind, Placebo‐Controlled Phase I Clinical Trial by Andrew Leber, Raquel Hontecillas, Nuria Tubau‐Juni, Josep Bassaganya‐Riera

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Economic evaluation of a strategy to shorten the time to surgery with neuraxial anaesthesia compared with usual clinical practice in patients on chronic antiplatelet therapy with a... by Claudia Erika Delgado-Espinoza, Rosa Maria Antonijoan, Ignasi Gich, Ignasi Gich, Rafael Anaya, Mireia Rodriguez, Angélica Millan, Jordi Llorca, Gemma Usua, Ana Ruiz, Angela Merchán-Galvis, Angela Merchán-Galvis, Maria Jose Martinez-Zapata, Maria Jose Martinez-Zapata

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Effectiveness of an HIV peer support precision matching platform: a randomized controlled trial protocol by Xin Xie, Shuyu Han, Yangfeng Wu, Tao Huang, Junyi Duan, Dongmei Li, Shuyu Chen, Bo Zhou, Jiangping Zhang, Lili Zhang

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A randomized, double-blind, Phase 1, single- and multiple-dose placebo-controlled study of the safety and pharmacokinetics of IN-006, an inhaled antibody treatment for COVID-19 in... by Thomas R. Moench, Lakshmi Botta, Brian Farrer, Jason D. Lickliter, Hyunah Kang, Yoona Park, Cheolmin Kim, Marshall Hoke, Miles Brennan, Morgan D. McSweeney, Zachary Richardson, John B. Whelan, Jong Moon Cho, Soo Young Lee, Frances Faurot, Jeff Hutchins, Samuel K. Lai

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Collagenase Chemonucleolysis for Treating Cervical Disc Herniation: An Exploratory, Single-Arm, Open-Label, Multicenter Clinical Trial by Zhijian Wang, Bifa Fan, Lili Gu, Xuexue Zhang, Tao Sun, Hui Liu, Rongchun Li, Likui Wang, Kaiqiang Wang, Shun Li, Yong Ma, Haibo You, Daying Zhang

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Phase 1 study of safety, tolerability, and efficacy of intradermal DNA vaccine ASP2390 in adults allergic to house dust mites by Thomas Kayser, MD, BS, Ronald Smulders, MD, PhD, Tomohiro Kusawake, PhD, Erik Wambre, PhD, Gurunadh R. Chichili, PhD, Mary B. Blauwet, DrPH, Anna Spence, MS, Melanie Patton, BS, Rima Tabash, PhD, Hannah A. DeBerg, PhD, Sugandhika Khosa, MS, Philipp Badorrek, MD, Jens M. Hohlfeld, MD, Brian C. Ferslew, PharmD, PhD

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Sample size calculations based on day-to-day variability of stress biomarkers in persons with dementia and their family caregivers by Azita Emami, Jeehye Jun, Gabriella Engström, Lars Berglund, Töres Theorell

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Pilot clinical trial of neoadjuvant toll-like receptor 7 agonist (Imiquimod) immunotherapy in early-stage oral squamous cell carcinoma by Angela J. Yoon, Richard D. Carvajal, Evan M. Graboyes, John M. Kaczmar, William G. Albergotti, Alexandra E. Kejner, Scott H. Troob, Elizabeth Philipone, Jean-Sebastien Anoma, Kent E. Armeson, Elizabeth G. Hill, Mary S. Richardson, Tina R. Woods, Bhishamjit S. Chera, Farzad Nourollah-Zadeh, Byung J. Lee, Subramanya Pandruvada, Antonis Kourtidis, Christina Kingsley, Elizabeth C. O’Quinn, Stephanie Mills, Victoria C. Jordan, Mike Spencer, Danielle Fails, Trevor D. McKee, Mark Zaidi, Alan Brisendine, Shane Horn, Shikhar Mehrotra, Besim Ogretmen, Jason G. Newman

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Development, opportunities, and challenges of siRNA nucleic acid drugs by Bowen Xiao, Shaopeng Wang, Yu Pan, Wenjun Zhi, Chensheng Gu, Tao Guo, Jiaqi Zhai, Chenxu Li, Yong Q. Chen, Rong Wang

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Real-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA... by Sho Furusawa, Hiroshi Nomoto, Chiho Oba-Yamamoto, Jun Takeuchi, Miki Ito, Hiroyoshi Kurihara, Shin Aoki, Aika Miya, Hiraku Kameda, Akinobu Nakamura, Tatsuya Atsumi

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Re-analysis of the current status of clinical trial registration in China by Shuwen Li, Shuwen Li, Jianhao Li, Wenjing Zeng, Zhicheng Li, Jietong Zhang, Siying Wang, Nenggui Xu, Zeli Li, Zeli Li

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Demographic clinical trial diversity assessment methods: Use of real-world data by Hua Chen, Nnadozie Emechebe, Sudeep Karve, Leon Raskin, Jailene Leal, Ning Cheng, Wendy Sebby, Kim Ribeiro, Samuel Crawford

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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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