Metformin versus insulin in glycemic control in pregnancy (MevIP): a randomized clinical trial protocol by Carolina Freitas Alves Amaral-Moreira, Daiane Sofia Morais Paulino, Belmiro G. Pereira, Patricia Moretti Rehder, Fernanda G. Surita

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Enhancing vaccine clinical trials participation among elderly: challenges and strategies by Paul Gillard, Samer Nakhle, Darin Brimhall, Ouzama Henry, Narcisa Mesaros

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Protocol paper: randomized controlled trial of the smart online-to-offline model development for chronic diseases management through digital health in real world setting by Jae Eun Shin, Juho Choi, Heejung Lee, Suk-Won Lee, Juhwan Oh

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The effect of educational intervention based on the mobile application on women’s knowledge, attitude, and practice on microplastics and health: study protocol for a randomized con... by Zahra Seifi, Fatemeh Zarei, Fazlollah Ahmadi

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Non-inferiority study to compare the efficacy of relugolix with dienogest for endometriosis-associated pain and usefulness of administering relugolix prior to dienogest (READY stud... by Fuminori Taniguchi, Motoko Fukui, Yutaka Osuga, Tasuku Harada, Jo Kitawaki

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Antisecretory factor in severe traumatic brain injury (AFISTBI): protocol for an exploratory randomized placebo-controlled trial by Linus Réen, David Cederberg, Niklas Marklund, Edward Visse, Peter Siesjö

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Understanding Cognition, Oxytocin, and Pain in Elders (UCOPE): protocol for a double-blinded cross-over trial in chronic knee osteoarthritis pain by Yenisel Cruz-Almeida, Soamy Montesino-Goicolea, Pedro Valdes-Hernandez, Zhiguang Huo, Roland Staud, Natalie C. Ebner

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Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials {1} by Inês A. Trindade, Andreia Soares, David Skvarc, Diogo Carreiras, Joana Pereira, Óscar Lourenço, Filipa Sampaio, Bruno de Sousa, Teresa C. Martins, Paula Boaventura, Joana Marta-Simões, Mind Project Team, Helena Moreira

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TARGET Protein: the effect of augmented administration of enteral protein to critically ill adults on clinical outcomes—statistical analysis plan for a cluster randomized, cross-se... by Sophie Zaloumis, Matthew J. Summers, Jeffrey J. Presneill, Rinaldo Bellomo, Lee-anne S. Chapple, Marianne J. Chapman, Adam M. Deane, Suzie Ferrie, Craig French, Sally Hurford, Nima Kakho, Matthew J. Maiden, Stephanie N. O’Connor, Sandra L. Peake, Emma J. Ridley, An Tran-Duy, Patricia J. Williams, Paul J. Young, Amalia Karahalios, on behalf of the TARGET Protein Investigators, the Australian, New Zealand Intensive Care Society Clinical Trials Group

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Adapting MOVED as a web-based moral elevation intervention for veterans with PTSD: Using feedback from a pilot trial and subject matter experts by Adam P. McGuire, Alexander Riera, Xrystyan Lascano

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Structures and strategies for retaining an international pediatric cohort from birth: Lessons from The Environmental Determinants of Diabetes in the Young (TEDDY) study by Patricia Gesualdo, Jessica Melin, Rachel Karban, Claire Crouch, Michael Killian, Diane Hopkins, Annika Adamsson, Joanna Stock, Suzanne Bennett Johnson, Judith Baxter

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Real-world enrollment for a prospective clinico-genomic database using a pragmatic technology-enabled platform by Alexia Exarchos, Ariel B. Bourla, Maneet Kaur, Katja Schulze, Sophia Maund, Yi Cao, Yihua Zhao, Elizabeth H. Williams, Sarah C. Gaffey, Richard Zuniga, Shaily Lakhanpal, Vladan Antic, Michelle Doral, Johanna Sy, Neal J. Meropol, Anne C. Chiang

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Rationale and design for Healthy Hearts in Manufacturing (HHM): A pragmatic single-arm hybrid effectiveness-implementation study for hypertension management and tobacco cessation by Hanzi Jiang, Yao Tian, Jennifer Bannon, Amy E. Krefman, Lawrence C. An, Dustin D. French, Claude R. Maechling, Jane Holl, Richard Chagnon, Theresa L. Walunas, Christopher Burch, Anthony Musci, Darce Latsis, Dawn Carey, Megan McHugh

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“Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (... by Sabah Attar, Carla Peacock, Mandy Wan, Erin Halil, Chloe Bickerstaff, Lionel Tan, Hafsah Bhatti, Ricardo M. Fernandes, Regis Hankard, Mark A. Turner

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