Safety outcome trials in four mainline medical journals 30 years apart: a narrative review and the need for the transparency of informed consents by Sinem Nihal Esatoglu, Ayse Ozdede, Yesim Ozguler, Koray Tascilar, Hasan Yazici

Subjects: “…Randomized controlled trials…”
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The role of sacubitril/valsartan in abnormal renal function patients combined with heart failure: a meta-analysis and systematic analysis by Xinyue Yang, Jingjing Jin, Meijuan Cheng, Jinsheng Xu, Yaling Bai

Subjects: “…randomized controlled trials…”
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Use of the chronic illness research recruitment taxonomy to evaluate recruitment strategies in an eHealth feasibility study. by Rosalynn C. Austin, Anne Marie Lunde Husebø, Hege Wathne, Marianne Storm, Kristin H. Urstad, Ingvild Morken, Bjørg Karlsen

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Evaluation of Bacillus coagulans LMG S-31876 for immunomodulation and stress: a double-blind, placebo-controlled clinical trial by Ranjith Kumar Kallur, Sreenadh Madapati, Mayuri Banerjee, Ankita Mathur, Sourish Bhattacharya

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Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process by Breanne Stewart, Pirkko Lepola, Gunter F. Egger, Fahimeda Ali, Albert J. Allen, Albert J. Allen, Alysha K. Croker, Andrew J. Davidson, Pamela Dicks, Saul N. Faust, Saul N. Faust, Dionna Green, Collin Hovinga, Collin Hovinga, Agnes V. Klein, Robyn Langham, Hidefumi Nakamura, Laura Pioppo, Shiva Ramroop, Michiyo Sakiyama, Isabel Sanchez Vigil de la Villa, Junko Sato, Donna L. Snyder, Mark A. Turner, Mark A. Turner, Sarah Zaidi, Kanecia Zimmerman, Kanecia Zimmerman, Thierry Lacaze-Masmonteil

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SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocolsResearch in context by Moreno Ursino, Guillermo Villacampa, Jan Rekowski, Munyaradzi Dimairo, Olga Solovyeva, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Thomas R. Jeffry Evans, Elizabeth Garrett-Mayer, Robert M. Golub, Christina Guo, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Adrian Mander, Lynley V. Marshall, James Matcham, Dhrusti Patel, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Mahtab Rouhifard, Lesley Seymour, Yoshiya Tanaka, Christopher J. Weir, Johann de Bono, Christina Yap

Subjects: “…Early phase trials…”
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Barriers and enablers to recruiting participants within paediatric perioperative and anaesthetic settings: lessons learned from a trial of melatonin versus midazolam in the premedi... by Marie C. Hyslop, Diana E. Papaioannou, Robert Bolt, Matthew J. Wilson, Michael Bradburn, Janet Clarkson, Esther Herbert, Nicholas Ireland, Jennifer Kettle, Amanda Loban, Amy C. Norrington, Christopher Vernazza, Christopher Deery

Subjects: “…early termination of clinical trials…”
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An automatic fermentation nutrition system compared to a traditional one: fermentation performances and composition of white wines by Matteo, Clara Vitaggio, Fabrizio Ghinolfi, Filippo Amato, Luciano Cinquanta, Onofrio Corona

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CONSORT-DEFINE explanation and elaboration: recommendations for enhancing reporting quality and impact of early phase dose-finding clinical trialsResearch in context by Jan Rekowski, Christina Guo, Olga Solovyeva, Munyaradzi Dimairo, Mahtab Rouhifard, Dhrusti Patel, Emily Alger, Deborah Ashby, Jordan Berlin, Oliver Boix, Melanie Calvert, An-Wen Chan, Courtney H. Coschi, Johann de Bono, Thomas R. Jeffry Evans, Elizabeth Garrett–Mayer, Robert M. Golub, Kathryn S. Hayward, Sally Hopewell, John D. Isaacs, S. Percy Ivy, Thomas Jaki, Olga Kholmanskikh, Andrew Kightley, Shing Lee, Rong Liu, Israel Maia, Adrian Mander, Lynley V. Marshall, James Matcham, Richard Peck, Khadija Rerhou Rantell, Dawn P. Richards, Lesley Seymour, Yoshiya Tanaka, Moreno Ursino, Christopher J. Weir, Christina Yap

Subjects: “…Early phase trials…”
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Fermented Ophiocordyceps sinensis mycelium products for preventing contrast-associated acute kidney injury: a systematic review of randomized controlled trials by Fenglan Pu, Tianli Li, Chen Shen, Yingqiao Wang, Chunmei Tang, Xiaowen Zhang, Lijiao Yan, Qihe Xu, Jianping Liu

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TAD-SIE: sample size estimation for clinical randomized controlled trials using a Trend-Adaptive Design with a Synthetic-Intervention-Based Estimator by Sayeri Lala, Niraj K. Jha

Subjects: “…Clinical randomized controlled trials…”
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The efficacy and safety of Ginkgo biloba L. leaves extract combined with ACEI/ARB on diabetic kidney disease: a systematic review and meta-analysis of 41 randomized controlled tria... by Zehua Zhang, Shiyun Tang, Shiyu Liu, Yulin Leng, Xiaoxu Fu, Hongyan Xie, Hong Gao, Hong Gao, Chunguang Xie, Chunguang Xie

Subjects: “…randomized controlled trials…”
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Grammar-constrained decoding for structured information extraction with fine-tuned generative models applied to clinical trial abstracts by David M. Schmidt, Philipp Cimiano

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Impact of subgingival periodontal treatment on systemic markers of inflammation in patients with metabolic syndrome: a systematic review of randomized clinical trials by Marie Chavez, Asshly Ramirez, Akram Hernández-Vásquez, Daniel Comandé, Diego Azañedo

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Advantages and challenges of using arterial spin labelling MRI to monitor cerebral blood flow in multi-centre clinical trials of neurodegenerative disease: Experience from the RADA... by Lina Jarutyte, Jan Petr, Nicholas Turner, Patrick G. Kehoe, Henk-Jan Mutsaerts, David L. Thomas

Subjects: “…Multi-centre randomised controlled trials…”
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Evaluating the overall renal outcomes of sodium-glucose cotransporter-2 (SGLT2) inhibitors in patients with chronic kidney disease (CKD) by Min-Jia Cao, Ting-Ting Liang, Li Xu, Fang-Hong Shi

Subjects: “…Randomized controlled trials…”
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Comparative the efficacy and safety of Gosuranemab, Semorinemab, Tilavonemab, and Zagotenemab in patients with Alzheimer’s disease: a systematic review and network meta-analysis of... by Wenting Cai, Wenting Cai, Hui Zhang, Hui Zhang, Yan Wu, Yan Wu, Yao Yao, Jinping Zhang

Subjects: “…randomized controlled trials…”
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Effects of dipeptidyl peptidase 4 inhibitors on the risk of acute respiratory failure in patients with type 2 diabetes mellitus: a meta-analysis of cardiovascular outcomes trials by Yan Wang, Caiyuan Yu, Xiaoyan Zheng, Yaya Wang, Wei Zhang

Subjects: “…cardiovascular outcomes trials…”
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Advances in therapies using mesenchymal stem cells and their exosomes for treatment of peripheral nerve injury: state of the art and future perspectives by Fatima Aldali, Chunchu Deng, Mingbo Nie, Hong Chen

Subjects: “…clinical trials…”
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Challenges and ongoing initiatives towards better integrated EU scientific advice by Iordanis Gravanis, Michael Berntgen, Spiros Vamvakas, Pierre Demolis, Paolo Foggi

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