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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 PDFOxidative and Excitatory Neurotoxic Stresses in CRISPR/Cas9-Induced Kynurenine Aminotransferase Knockout Mice: A Novel Model for Despair-Based Depression and Post-Traumatic Stress Disorder.
Front Biosci (Landmark Ed)
January 2025
HUN-REN-SZTE Neuroscience Research Group, Hungarian Research Network, University of Szeged (HUN-REN-SZTE), Danube Neuroscience Research Laboratory, H-6725 Szeged, Hungary.
Backgrounds: Memory and emotion are especially vulnerable to psychiatric disorders such as post-traumatic stress disorder (PTSD), which is linked to disruptions in serotonin (5-HT) metabolism. Over 90% of the 5-HT precursor tryptophan (Trp) is metabolized via the Trp-kynurenine (KYN) metabolic pathway, which generates a variety of bioactive molecules. Dysregulation of KYN metabolism, particularly low levels of kynurenic acid (KYNA), appears to be linked to neuropsychiatric disorders.
View Article and Find Full Text PDFPredictive Value of Ocular Fundus Hemorrhage for Severe Coronary Artery Disease Assessed via SYNTAX Score.
Br J Hosp Med (Lond)
January 2025
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China.
The relationship between retinal fundus hemorrhage and the severity of coronary artery lesions remains unclear. This study aimed to explore the incidence of fundus hemorrhage in patients at high risk of coronary heart disease (CHD) and to examine its correlation with the SYNTAX score, a tool used to assess the complexity of coronary artery disease. This retrospective study consecutively enrolled patients undergoing coronary angiography (CAG) at Beijing Anzhen Hospital Hospital from June 2019 to January 2020.
View Article and Find Full Text PDFNeural Correlates of Social Touch Processing: An fMRI Study on Brain Functional Connectivity.
J Integr Neurosci
January 2025
Laboratory for the Study of Tactile Communication, Pushkin State Russian Language Institute, 117485 Moscow, Russia.
Background: The significance of tactile stimulation in human social development and personal interaction is well documented; however, the underlying cerebral processes remain under-researched. This study employed functional magnetic resonance imaging (fMRI) to investigate the neural correlates of social touch processing, with a particular focus on the functional connectivity associated with the aftereffects of touch.
Methods: A total of 27 experimental subjects were recruited for the study, all of whom underwent a 5-minute calf and foot massage prior to undergoing resting-state fMRI.
The Line of Emotion Dysregulation and Need Frustration from Parents to Adolescents: The Role of Parental Psychological Control.
J Genet Psychol
January 2025
Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Accumulating evidence, as outlined by Self-Determination Theory (SDT), highlights the crucial role of emotion dysregulation and basic psychological needs in shaping various psychological outcomes. Parental psychological control may play a key role in understanding how these processes develop within the family context. This study aims to examine the intergenerational transmission of basic psychological needs and emotion dysregulation from parents to adolescents, focusing on the indirect association of parental psychological control within this relationship.
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