Developing an Artificial Intelligence-Guided Signal Detection in the Food and Drug Administration Adverse Event Reporting System (FAERS): A Proof-of-Concept Study Using Galcanezumab and Simulated Data.

Introduction: Time- and resource-demanding activities related to processing individual case safety reports (ICSRs) include manual procedures to evaluate individual causality with the final goal of dismissing false-positive safety signals. Eminent experts and a representative from pharmaceutical industries and regulatory agencies have highlighted the need to automatize time- and resource-demanding procedures in signal detection and validation. However, to date there is a sparse availability of automatized tools for such purposes.

A machine-learning guided method for predicting add-on and switch in secondary data sources: A case study on anti-seizure medications in Danish registries.

There is a lack of available evidence regarding the treatment pattern of switches and add-ons for individuals aged 65 years or older with epilepsy during the first years from the time they received their first anti-seizure medication because of the lack of valid methods. Therefore, this study aimed to develop an algorithm for identifying switches and add-ons using secondary data sources for anti-seizure medication users. Danish nationwide databases were used as data sources.

Folic acid supplementation in postmenopausal women with hot flushes: phase III randomised double-blind placebo-controlled trial.

Objective: To assess whether folic acid supplementation ameliorates hot flushes.

Design: Double-blind, placebo-controlled randomised trial.

Setting: Nine hospitals in England.

Microsatellite variation of ESR1, ESR2, and AR in Serbian women with primary ovarian insufficiency.

Objective: This study aimed to investigate the potential role of microsatellite polymorphisms of the estrogen receptor alpha gene (ESR1) TA repeat, estrogen receptor beta gene (ESR2) CA repeat, and androgen receptor gene (AR) CAG and GGN repeats among Serbian women with primary ovarian insufficiency (POI). These microsatellites have been reported to be associated with POI in different racial/ethnic populations.

Methods: A cohort of 196 POI cases matched with 544 fertile controls was recruited by the Institute for Endocrinology, Diabetes and Metabolic Disorders of Serbia between 2007 and 2010.