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Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022.
Clin Trials
January 2025
Rare Diseases Team, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Background/aims: Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.
View Article and Find Full Text PDFEffectiveness of blood flow restriction training during a taper phase in basketball players.
J Sports Sci
January 2025
Department of Tourism, Sport and Society, Lincoln University, Christchurch, New Zealand.
This study investigates the effectiveness of blood flow restriction (BFR) training in maintaining athletic performance during a taper phase in basketball players. The taper phase aims to reduce external load while maintaining training intensity. Seventeen experienced basketball players were randomised into two groups: a placebo group ( = 8, 22.
View Article and Find Full Text PDFERK1/2 Inhibition Alleviates Diabetic Cardiomyopathy by Suppressing Fatty Acid Metabolism.
Front Biosci (Landmark Ed)
January 2025
Department of Biomedical Sciences, Grand Valley State University, Allendale, MI 49401, USA.
Background: Diabetes mellitus is associated with morphological and functional impairment of the heart primarily due to lipid toxicity caused by increased fatty acid metabolism. Extracellular signal-regulated protein kinases 1 and 2 (ERK1/2) have been implicated in the metabolism of fatty acids in the liver and skeletal muscles. However, their role in the heart in diabetes remains unclear.
View Article and Find Full Text PDFMonocyte and Macrophage in Follicular Liquid: Predictive Markers of Embryo Quality in Women with Obesity and Infertility.
Front Biosci (Landmark Ed)
January 2025
Division of Biochemistry and Molecular Biology, Federal State Budgetary Educational Institution of Higher Education "Siberian State Medical University" of the Ministry of Health of Russia, 634050 Tomsk, Russia.
Background: Over the past five years, the pregnancy rate in assisted reproductive technology (ART) programs in Russia has remained relatively stable. The aim of this study was to assess the distribution of monocyte and macrophage subsets in the blood and follicular fluid of infertile women undergoing assisted reproductive technology.
Methods: The study involved 45 women with a mean age of 35 ± 4.
tiRNA-Gln-CTG is Involved in the Regulation of Trophoblast Cell Function in Pre-eclampsia and Serves as a Potent Biomarker.
Front Biosci (Landmark Ed)
January 2025
Department of Obstetrics and Gynecology, Zhongda Hospital, School of Medicine, Southeast University, 210000 Nanjing, Jiangsu, China.
Background: Pre-eclampsia (PE) is a gestational disorder that significantly endangers maternal and fetal health. Transfer ribonucleic acid (tRNA)-derived small RNAs (tsRNAs) are important in the progression and diagnosis of various diseases. However, their role in the development of PE is unclear.
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