Large-scale evidence generation and evaluation across a network of databases for type 2 diabetes mellitus (LEGEND-T2DM): a protocol for a series of multinational, real-world compar... by Rohan Khera, Yuan Lu, Harlan M Krumholz, Martijn J Schuemie, Ruijun Chen, George Hripcsak, Marc A Suchard, Patrick B Ryan, Anna Ostropolets

“…The primary cardiovascular outcomes include a composite of major adverse cardiovascular events and a series of safety outcomes. The study will pursue data-driven, large-scale propensity adjustment for measured confounding, a large set of negative control outcome experiments to address unmeasured and systematic bias.Ethics and dissemination The study ensures data safety through a federated analytic approach and follows research best practices, including prespecification and full disclosure of results. …”
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MLL4 regulates postnatal palate growth and midpalatal suture development by Jung-Mi Lee, Hunmin Jung, Bruno de Paula Machado Pasqua, Yungki Park, Qinghuang Tang, Shin Jeon, Shin Jeon, Soo-Kyung Lee, Jae W. Lee, Hyuk-Jae Edward Kwon

“…Taken together, our results demonstrate that MLL4 is essential for orchestrating key cellular and molecular events that ensure proper midpalatal suture development and palate growth.…”
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Azithromycin to prevent acute lower respiratory infections among Australian and New Zealand First Nations and Timorese children (PETAL trial): study protocol for a multicentre, int... by Anne B Chang, Keith Grimwood, Yuejen Zhao, Gabrielle B McCallum, Catherine A Byrnes, Heidi Smith-Vaughan, Peter S Morris, Christine Connors, Adrian Trenholme, Shirley Lawrence, Joshua Francis, Kobi L Schutz, Mark D Chatfield, Nevio Sarmento, Robyn L. Marsh, Emily R Bowden, Nicholas Fancourt, Adriano Vieira, Kim M Hare, Dennis Bonney, Felicity Marwick, Bronwyn Karvonen, Carolyn Maclennan, Milena Santos Lay, Endang Soares da Silva

“…The secondary outcomes are the rates and proportions of children with ALRI-related hospitalisation, chronic symptoms/signs suggestive of underlying chronic suppurative lung disease or bronchiectasis, serious adverse events, and antimicrobial resistance in the upper airways, and cost-effectiveness analyses.Ethics and dissemination The Human Research Ethics Committees of the Northern Territory Department of Health and Menzies School of Health Research (Australia), Health and Disability Ethics Committee (New Zealand) and the Institute National of Health-Research Technical Committee (Timor-Leste) approved this study. …”
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Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer by Jieran Long, Xuefei Li, Lin Wu, Guohua Yu, Aimin Zang, Yanqiu Zhao, Jinsheng Shi, Ligong Nie, Xuan Zhao, Jian Fang

“…Grade 3 or higher adverse events were recorded in the 180 mg/m2 group, including diarrhea (11.5%, 3/26), neutropenia (7.7%, 2/26), and leukopenia (7.7%, 2/26). …”
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Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non–Left Main Location and Treatment Strategy by Ki Hong Choi, Chang‐Wook Nam, Francesco Bruno, Yun‐Kyeong Cho, Leonardo De Luca, Jeehoon Kang, Alessio Mattesini, Young Bin Song, Alessandra Truffa, Hyo‐Soo Kim, Wojciech Wańha, Woo Jung Chun, Sebastiano Gili, Gerard Helft, Seung Hwan Han, Bernardo Cortese, Cheol Hyun Lee, Javier Escaned, Hyuck‐Jun Yoon, Alaide Chieffo, Joo‐Yong Hahn, Guglielmo Gallone, Seung‐Hyuk Choi, Gaetano De Ferrari, Bon‐Kwon Koo, Giorgio Quadri, Seung‐Ho Hur, Fabrizio D'Ascenzo, Hyeon‐Cheol Gwon, Ovidio de Filippo

“…The primary end point was major adverse cardiac events (MACEs; composite of all‐cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) at 800 days. …”
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Exploring expressed concerns and uncanny feeling in patients with shortness of breath calling out-of-hours primary care by Michelle Spek, Dorien L. Zwart, Esther de Groot, Michelle R. Timmerman, Maarten van Smeden, Daphne C. A. Erkelens, Anna S. M. Dobbe, Mathé Delissen, Frans H. Rutten, Roderick P. Venekamp

“…We therefore explored the relation between expressed concerns and researcher’s judged uncanny feeling among patients who contact OHS-PC for SOB with potential life-threatening events (LTEs) as the outcome. Methods This is an explorative cross-sectional study. …”
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Efficacy and safety of Janus kinase inhibitors in the treatment of psoriasis and psoriatic arthritis: An analysis of evidence from 2014 to 2022 by Jiao Wang, Tian Ma, Xiaoying Sun, Liu Liu, Seokgyeong Hong, Huijung Cha, Miao Zhang, Jiale Chen, Naixuan Lin, Bin Li, Xin Li

“…The Psoriasis Area and Severity Index (PASI) 75 and American College of Rheumatology (ACR) 50 were established as primary outcome indicators of PSO and PsA, respectively. Adverse events (AEs) were classified according to eight systems of the human body. …”
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Long-term safety and sustained efficacy of bimekizumab in patients with ankylosing spondylitis (radiographic axial spondyloarthritis): 5-year results from BE AGILE (phase 2b) and i... by Sofia Ramiro, Désirée van der Heijde, Atul Deodhar, Xenofon Baraliakos, Denis Poddubnyy, Lianne S Gensler, Helena Marzo-Ortega, Natasha de Peyrecave, Victoria Navarro-Compán, Tetsuya Tomita, Carmen Fleurinck, Ute Massow, Thomas Vaux

“…Safety (exposure-adjusted incidence rates/100 patient-years (EAIRs)) and efficacy outcomes (binary: non-responder imputation (NRI) and observed case (OC); continuous: multiple imputation (MI)) are presented through 256 weeks.Results From Weeks 0–256, 289/303 (95.4%) patients had ≥1 treatment-emergent adverse event (TEAE); most frequent were nasopharyngitis (21.8%) and upper respiratory tract infection (14.5%). …”
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First-in-human phase 1 dose-escalation results with livmoniplimab, an antibody targeting the GARP:TGF-ß1 complex, as monotherapy and in combination with the anti–PD-1 antibody budi... by Toshio Shimizu, Toshio Shimizu, John Powderly, Albiruni Abdul Razak, Patricia LoRusso, Kathy D. Miller, Steven Kao, Sarah Kongpachith, Catherine Tribouley, Michelle Graham, Brian Stoll, Maulik Patel, Mohammad Sahtout, Martha Blaney, Rachel Leibman, Talia Golan, Talia Golan, Anthony Tolcher

“…The most common adverse events reported in monotherapy-treated patients were fatigue, anemia, and nausea, and those in combination therapy-treated patients were pruritus, fatigue, nausea, and anemia. …”
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Evaluating the pharmacokinetics and safety of blonanserin tablets and Lonasen®: a randomized, open-label, two-period, two-sequence, self-crossover phase I clinical trial by Bo Qiu, Bo Qiu, Haojing Song, Haojing Song, Xue Sun, Xue Sun, Congyang Ding, Congyang Ding, Runxuan Du, Wanjun Bai, Wanjun Bai, Zhanjun Dong, Zhanjun Dong

“…Both the test and reference formulations were well-tolerated, and no serious adverse events related to the study drug were reported during the study.ConclusionThe bioequivalence of blonanserin tablets, both test and reference, was confirmed in healthy Chinese subjects under fasting and postprandial conditions, meeting the predetermined regulatory criteria for both formulations. …”
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Vegetation disturbance and regrowth dynamics in shifting cultivation landscapes by Yamini Bhat, Subrata Nandy, Krishna Das, Muna Tamang, Hitendra Padalia, Arun Jyoti Nath, Koushik Majumdar, Rocky Pebam, Pynkhlainbor Thongni, Bandana Kurmi, Ashesh Kumar Das, S. P.S. Kushwaha, R. P. Singh

“…Low-magnitude disturbance indicates a single slash-and-burn event in the past three decades, moderate-magnitude disturbance involves fallow periods of over 10 years, and high-magnitude disturbance occurs with fallow periods of less than 8 years. …”
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Relevance of the synergy of surveillance and populational networks in understanding the Usutu virus outbreak within common blackbirds (Turdus merula) in Metropolitan France, 2018 by Bouchez-Zacria, Malika, Calenge, Clément, Villers, Alexandre, Lecollinet, Sylvie, Gonzalez, Gaelle, Quintard, Benoit, Leclerc, Antoine, Baurier, Florence, Paty, Marie-Claire, Faure, Éva, Eraud, Cyril, Decors, Anouk

“…Data (RT-PCR of geolocated dead birds) on this 2018 outbreak were collected through both an event-based wildlife network named SAGIR and the health surveillance of the French-speaking Association of Zoo Veterinarians (AFVPZ). …”
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Association between left ventricular reverse remodelling and the B-type natriuretic peptide–cGMP cascade after anterior acute myocardial infarction by Satoshi Yasuda, Kunihiro Nishimura, Kensuke Takagi, Hiroyuki Takahama, Naoto Minamino, Masashi Fujino, Satoshi Honda, Yasuhide Asaumi, Yu Kataoka, Fumiyuki Otsuka, Soshiro Ogata, Teruo Noguchi, Takahiro Nakashima, Kenichiro Sawada, Yoshiaki Morita, Kazuhiro Nakao, Hiroyuki Miura, Takamasa Iwai, Marina Arai, Eri Kiyoshige, Kota Murai, Hideo Matama, Shuichi Yoneda

“…The LVRR group (n=33) had residuals below the median; the non-LVRR group (n=34) had residuals at or above the median.Results The LVRR group had higher freedom from major adverse cardiac and cerebrovascular events (MACCEs) than the non-LVRR group during a median follow-up of 9.9 years (p=0.008). …”
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Efficacy and Safety of Dual Antiplatelet Therapy in Patients Undergoing Coronary Stent Implantation: A Systematic Review and Network Meta-Analysis by Yi Xu, Yimin Shen, Delong Chen, Pengfei Zhao, Jun Jiang

“…Primary endpoints were all-cause mortality, cardiac death, myocardial infarction (MI), major bleeding, any bleeding, definite or probable stent thrombosis (ST), and net adverse clinical events (NACE). This Bayesian network meta-analysis was performed with the random-effects model. …”
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Medication adherence and blood pressure control in treated hypertensive patients: first follow-up findings from the PREDIcT-HTN study in Northern Bangladesh by Ahmed Hossain, Gias Uddin Ahsan, Mohammad Zakir Hossain, Mohammad Anwar Hossain, Probal Sutradhar, Sarowar-E. Alam, Zeeba Zahra Sultana, Heba Hijazi, Syed Azizur Rahman, Mohamad Alameddine

“…Methods The PREDIcT-HTN study in Northern Bangladesh aims to evaluate major adverse clinical events in treated hypertensive patients. The study involves 2643 hypertensive patients from a medical center, with data collected through baseline information and yearly follow-ups until 2025. …”
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TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing–Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program by Pierre Labauge, Alain Créange, Thibault Moreau, Jocelyne Nouvet-Gire, Bernard Pedespan, Olivier Heinzlef, Nathalie Texier, Marilyn Gros, Catherine Marti, Marta Ruiz, Mikel Martinez, Giovanni Castelnovo

“…Secondary outcomes included persistence at M1 and M3, adherence at M6 (Girerd questionnaire), anxiety (Generalized Anxiety Disorder Assessment), patient satisfaction at M6 (Treatment Satisfaction Questionnaire for Medication), patient and neurologist satisfaction with OroSEP participation, and adverse events (AEs). Results Per-protocol population included 341 patients (OroSEP, n = 135; SoC, n = 206). …”
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Clinical benefits of modifying the evening light environment in an acute psychiatric unit: A single-centre, two-arm, parallel-group, pragmatic effectiveness randomised controlled t... by Håvard Kallestad, Knut Langsrud, Melanie Rae Simpson, Cecilie Lund Vestergaard, Daniel Vethe, Kaia Kjørstad, Patrick Faaland, Stian Lydersen, Gunnar Morken, Ingvild Ulsaker-Janke, Simen Berg Saksvik, Jan Scott

“…Inpatients exposed to the blue-depleted evening light showed higher improvement during admission (CGI-I difference 0.28 (95% CI [0.02, 0.54]; p = 0.035), Number Needed to Treat for clinically meaningful improvement (NNT): 12); lower illness severity at discharge (CGI-S difference -0.18 (95% CI [-0.34, -0.02]; p = 0.029), NNT for mild severity at discharge: 7); and lower levels of aggressive behaviour (difference in BVC predicted serious events per 100 days: -2.98 (95% CI [-4.98, -0.99]; p = 0.003), NNT: 9). …”
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Anatomical and Functional Outcomes of Vitrectomy with/without Intravitreal Methotrexate Infusion for Management of Proliferative Vitreoretinopathy Secondary to Rhegmatogenous Retin... by Samir El Baha, Mahmoud Leila, Ahmed Amr, Mohamed M. A. Lolah

“…The Kaplan–Meier method was used for survival analysis and the log-rank test estimated differences in event-free survival across the groups. P was significant at <0.05. …”
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Implementasi Model Pembelajaran Rekreasi-Prokreasi dalam Membaca Kritis Teks Eksplanasi di SMK by Bambang Eko Hari Cahyono, Lulus Irawati, Devit Tri Candrawati

“…This descriptive qualitative research uses data sources in the form of informants, events, and documents. The selected informants were Indonesian Language teachers and class XI students. …”
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United by Sports? Key Factors affecting Sports Participation in a Sports-based Initiative to Promote Social Integration in Segregated Communities by Anna Boemmel, Matthias Buser, Thomas Persson

“…Results/Discussion The study concludes that key factors, such as interactions with people from diverse backgrounds in safe environments, a physical activity and education component, exceptional events, and networking opportunities, significantly enrich participants' experiences and encourage continued participation in sports for integration initiatives. …”
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