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Hum Reprod Open
January 2025
Regional Center of Pharmacovigilance, Pharmacology Department, Cochin Hospital, AP-HP.Centre-Université Paris Cité, Paris, France.
Study Question: Is there an association between dydrogesterone exposure during early pregnancy and the reporting of birth defects?
Summary Answer: This observational analysis based on global safety data showed an increased reporting of birth defects, mainly hypospadias and congenital heart defects (CHD), in pregnancies exposed to dydrogesterone, especially when comparing to progesterone.
What Is Known Already: Intravaginal administration of progesterone is the standard of care to overcome luteal phase progesterone deficiency induced by ovarian stimulation in ART. In recent years, randomized controlled clinical trials demonstrated that oral dydrogesterone was non-inferior for pregnancy rate at 12 weeks of gestation and could be an alternative to micronized vaginal progesterone.
J Speech Lang Hear Res
January 2025
Center for Laryngeal Surgery and Voice Rehabilitation, Massachusetts General Hospital, Boston.
Purpose: The Daily Phonotrauma Index (DPI) can quantify pathophysiological mechanisms associated with daily voice use in individuals with phonotraumatic vocal hyperfunction (PVH). Since DPI was developed based on weeklong ambulatory voice monitoring, this study investigated if DPI can achieve comparable performance using (a) short laboratory speech tasks and (b) fewer than 7 days of ambulatory data.
Method: An ambulatory voice monitoring system recorded the vocal function/behavior of 134 females with PVH and vocally healthy matched controls in two different conditions.
Simul Healthc
January 2025
From the Department of Human Factors (H.S., Y.P., E.T., L.D.W.), Center for the Simulation, Research, and Patient Safety, Carilion Clinic, Roanoke, VA; and Health Systems and Implementation Science (S.H.P.), Virginia Tech Carilion School of Medicine, Roanoke, VA.
Introduction: Virtual Monitor Technicians (VMTs) are crucial in remotely monitoring inpatient telemetry. However, little is known about VMT workload and intratask performance changes, and their potential impact on patient safety. This exploratory study used a high-fidelity simulation aimed to evaluate VMTs' workload and performance changes over time in telemetry monitoring and identify future research directions for performance improvement.
View Article and Find Full Text PDFBr J Clin Pharmacol
January 2025
Department of Drug Science and Technology, University of Turin, Turin, Italy.
Aims: In Europe, the European Medicines Agency (EMA) has an accelerated pathway to prioritize approval of medicines. Approved drugs are then assessed by Health Technology Assessment (HTA) bodies before being made available to patients. The aim of the study was to evaluate the characteristics of the drugs admitted to the EMA accelerated assessment (AA) and scrutinize the downstream HTA procedures regarding these medicines and the final assessment regarding added therapeutic value (ATV).
View Article and Find Full Text PDFInt J Surg
December 2024
Hepatobiliary Surgery Department, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
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