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Assessment of adverse events of tasimelteon: a real-world pharmacovigilance study based on FAERS.

BACKGROUND: Tasimelteon is a novel dual melatonin receptor agonist approved for the treatment of non-24-hour sleep-wake disorder (N24HSWD). The purpose of this study was to provide a comprehensive analysis of post-marketing adverse events (AEs) for tasimelteon by analyzing the U.S. FDA Adverse Event Reporting System (FAERS) database. METHODS: Four algorithms are employed in this study to mine the significant signals: multi-item gamma poisson shrinker (MGPS), Bayesian confidence propagation neural network (BCPNN), reporting odds ratio (ROR), and proportional reporting ratio (PRR). RESULTS: Ta

Multicentre study on nirsevimab: Bayesian analysis reveals persisting risk for preterm infants.

OBJECTIVE: To evaluate whether the timing and effectiveness of nirsevimab prophylaxis vary by gestational age. DESIGN: Retrospective cohort study conducted during two identical epidemic seasons: 2023-2024 (before nirsevimab introduction) and 2024-2025 (after nirsevimab introduction). SETTING: Multicentre study involving five hospitals in Italy. PATIENTS: All infants under 1 year of age hospitalised for acute lower respiratory tract infection across two consecutive respiratory syncytial virus (RSV) seasons. We compared the number of RSV-positive hospitalisations (283 cases) and, among those

Under-five mortality and its associated factors in sub-Saharan Africa: a multilevel analysis of recent demographic and health surveys data based on Bayesian approach.

BACKGROUND: An estimated 75.8 under-five deaths per 1000 live births occurred in sub-Saharan Africa. This study aimed to investigate the prevalence and factors associated with under-five mortality in Sub-Saharan Africa. METHODS: This study was based on secondary data sources from 33 Sub-Saharan countries' recent Demography and Health surveys from 2010 to 2020. A weighted sample of 360,397 under-five children was included in the study. Bayesian multilevel binary logistic regression was fitted using the brms R package. Besides, leave one out information criteria was used for model comparison. T

A disproportionality analysis of nifedipine in the overall population and in pregnant women using the FDA Adverse Event Reporting System (FAERS) database.

Nifedipine, a dihydropyridine calcium channel blocker, is widely used in the management of hypertension and as a tocolytic agent to delay preterm labor, including in pregnant women. However, its safety profile, particularly in pregnant populations, remains insufficiently characterized. This study aimed to evaluate adverse event (AE) signals associated with nifedipine use, with a specific focus on pregnancy-related outcomes. Nifedipine-related AEs reported in U.S. Food and Drug Administration Adverse Event Reporting System database (Q1 2004-Q4 2024) were analyzed. Disproportionality analysis wa

[Construction and preliminary validation of machine learning predictive models for cervical cancer screening based on human DNA methylation].

Objective: Using methylation characteristics of human genes to construct machine learning predictive models for screening cervical cancer and precancerous lesions. Methods: Human DNA methylation detection was performed on 224 cervical exfoliated cell specimens from the Cancer Hospital of the Chinese Academy of Medical Sciences, Tianjin Central Hospital of Gynecology Obstetrics, Xinmi Maternal and Child Health Hospital of Henan Province, West China Second Affiliated Hospital of Sichuan University, and Heping Hospital Affiliated to Changzhi Medical College collected during April 2014 and March 2

Trends and gender disparities in the burden of rheumatoid arthritis in Pakistan from 1990 to 2021.

Rheumatoid arthritis (RA) significantly drives global morbidity and mortality, yet its evolving impact in low- and middle-income countries remains underexplored. This study harnesses extensive global burden of disease (GBD) data to delineate the temporal trends of RA burden in the Islamic Republic of Pakistan from 1990 to 2021, examine its association with socio-demographic development, and forecast future trajectories through 2036. This retrospective epidemiological study quantified RA disease metrics in Pakistan through GBD data interrogation. Joinpoint regression modeling delineated tempora

Trends in the global burden of low back pain and neck pain in individuals aged 15 to 49 years, 1990 to 2021, and projections through 2036: An age-period-cohort analysis study.

The objective of this study is to assess global trends and cross-country inequalities in low back pain (LBP) and neck pain (NP) burdens among adolescents and adults aged 15 to 49 years from 1990 to 2021 and project the disease burden through 2036. Data from the 2021 Global Burden of Disease study were used to analyze trends in the prevalence and years lived with disability for LBP and NP from 1990 to 2021. Age-standardized prevalence rates (ASPR) and years lived with disabilities were calculated, and trends were assessed using the average annual percent change (AAPC). Disparities across sociod

A disproportionality analysis of FDA adverse event reporting system (FAERS) events for filgotinib.

BACKGROUND: Although filgotinib, a selective Janus kinase 1 inhibitor, has been increasingly applied in the treatment of inflammatory diseases, its comprehensive safety profile remains insufficiently characterized. Using data from the FAERS database covering Q1 2014 to Q2 2024, this study attempts to analyze adverse event signals linked to filgotinib and provide guidance for the safe and sensible clinical usage of filgotinib. METHODS: From Q1 2014 to Q2 2024, information on adverse drug events (ADEs) associated with filgotinib was gathered. The reporting odds ratio (ROR), proportional reporti

Predictive Modeling of Hyperparathyroidism in Patients With Benign Thyroid Nodules: A Cohort Study Using the Vizient Database.

IMPORTANCE: Predicting primary hyperparathyroidism in data may facilitate earlier diagnosis and treatment. OBJECTIVE: Primary Hyperparathyroidism (pHPT) is the leading cause of hypercalcemia and up to 75% of hypercalcemic patients go undiagnosed. The purpose of this study was to examine the use of predictive modeling using a large clinical database to predict pHPT in patients with benign thyroid nodules. DESIGN: Retrospective analysis and predictive modeling of pHPT using a large discharge database. A predictive model of pHPT was created using logistic regression and compared to three machin

Global Burden of Non-Neoplastic Gynecological Diseases in Females: A 32-Year Analysis With Projections to 2100.

INTRODUCTION: Non-neoplastic gynecological diseases substantially affect women's health and quality of life worldwide, yet comprehensive analyses of their burden remain limited. METHODS: Using data from the Global Burden of Disease 2021 study, the prevalence, incidence and disability-adjusted life years of 7 gynecological conditions across 204 countries and territories from 1990 to 2021 were estimated. Temporal trends were assessed using joinpoint regression, and decomposition analysis quantified contributions of population growth, aging, and epidemiologic changes. Bayesian age-period-cohort

Bayesian Modeling to Project the National and Regional Burden of Rheumatic Heart Disease in Brazil Till 2050.

BACKGROUND: Rheumatic heart disease (RHD) remains a significant public health concern in middle- to low-income countries. Despite advancements in healthcare access and public health measures in Brazil, future projections of RHD burden are essential to guide policy-making. Thus, we projected the national and regional burden of RHD in Brazil through 2050. METHODS: Annual prevalence counts and disability-adjusted life years (DALYs) for RHD from 2000 to 2021 were extracted from the 2021 Global Burden of Disease (GBD) dataset for 10-year age brackets (5-74 years). Age-standardized prevalence (asPR

A Bayesian Multivariate Model With Temporal Dependence on Random Partition of Areal Data for Mosquito-Borne Diseases.

More than half of the world's population is exposed to mosquito-borne diseases, leading to millions of cases and hundreds of thousands of deaths every year. Analyzing this type of data is complex and poses several interesting challenges, mainly due to the usually vast geographic area involved, the peculiar temporal behavior, and the potential correlation between infections. Motivation for this work stems from the analysis of tropical disease data, namely, the number of cases of dengue and chikungunya, for the 145 microregions in Southeast Brazil from 2018 to 2022. As a contribution to the lite

Evaluating the performance of common reference laboratory tests for acute dengue diagnosis: a systematic review and meta-analysis of RT-PCR, NS1 ELISA, and IgM ELISA.

BACKGROUND: Dengue fever is listed among the top ten global health threats by WHO. Prompt identification of dengue virus can guide clinical management and outbreak response, yet laboratory diagnosis is complex, costly, and lacks consensus on performance evaluation. This systematic review aims to provide reliable diagnostic accuracy estimates in order to inform global guidance and evaluate novel rapid diagnostic tests. METHODS: In this systematic review and meta-analysis, we searched nine literature databases on Feb 16, 2021, for reports on five common reference tests for dengue infection: NS1

Картирование мозжечного мозга в случае задержек с проведением: следующий шаг для личностных моделей мозга в многоразовом склерозе.

Множественный склероз (MS) — клинически неоднородное, многофакторное аутоиммунное расстройство, затрагивающее центральную нервную систему. Структурные повреждения миелинской оболочки, приводящие к замедлению скорости проведения, являются ключевым патофизиологическим механизмом. На самом деле, скорость проведения тесно связана с степенью миэлизации, при этом более толстые миелиновые оболочки связаны с более высокой скоростью проведения. Однако не известно, как интенсивность структурных повреждений миелина ведет к замедлению течения нервной системы. В этой работе мы используем крупномасштабные м

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… Bayes theorem states that p θ / y = p θ p y / θ p y , where p θ / y is the probability of a hypothesis given the data (known as the posterior probability), p θ is the probability of the parameter before seeing any data (the probability of the hypothesis itself, known as the prior probability), …

Integrating Full Bayesian Inference and Student's t-Distribution Method for Enhanced Outlier Handling in Caffeine Population Pharmacokinetics: Assessing Drug-Drug Interactions with Enasidenib in Relapsed or Refractory AML and MDS Patients.

As the first-in-class, selective, and potent inhibitor of the isocitrate dehydrogenase-2 (IDH2) mutant protein, enasidenib was approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation. Known for its interactions with various cytochrome P450 (CYP) enzymes and transporters in vitro, a clinical pharmacokinetics (PK) trial was initiated to assess the impact of multiple doses of enasidenib on the single-dose PK of sensitive probe substrates of several cytochrome P450 enzymes and t

A Bayesian Dynamic Model-Based Adaptive Design for Oncology Dose Optimization in Phase I/II Clinical Trials.

With the development of targeted therapy, immunotherapy, and antibody-drug conjugates (ADCs), there is growing concern over the "more is better" paradigm developed decades ago for chemotherapy, prompting the US Food and Drug Administration (FDA) to initiate Project Optimus to reform dose optimization and selection in oncology drug development. For early-phase oncology trials, given the high variability from sparse data and the rigidity of parametric model specifications, we use Bayesian dynamic models to borrow information across doses with only vague order constraints. Our proposed adaptive d

Causality of inflammatory bowel disease and seborrheic keratosis: A bidirectional two-sample Mendelian randomization study.

BACKGROUND: Previous studies have revealed a potential link between inflammatory bowel disease (IBD) and seborrheic keratosis (SK). However, whether this association is causal or confounded remains unknown. METHODS: We conducted this two-sample Mendelian randomization (TSMR) analysis to clarify bidirectional causality between IBD, including its two primary conditions Crohn's disease (CD) and ulcerative colitis (UC), and SK. The summary genetic data of IBD, CD, UC and SK were obtained from accessible genome-wide association studies (GWAS). This TSMR study was primarily performed using inverse-

Comparing the short-term clinical outcomes and therapeutic effects of different colectomies in patients with refractory slow-transit constipation in eastern countries: a network meta-analysis.

Surgical treatment has been widely used in patients with refractory slow transit constipation (RSTC). The aim of this network meta-analysis (NMA) was to compare the effects of different colectomies on short-term postoperative complications and quality of life in patients with RSTC. Electronic literature searches were performed in the PubMed, Web of Science, EMBASE, WANFANG DATA, and Cochrane Central Register of controlled trials databases and were searched up to December 2022. Selected to compare the short-term clinical outcomes and quality of life of the treatment of RSTC. A random-effects Ba

Organ weights and length anthropometry measures at autopsy for sudden infant death syndrome cases and other infant deaths in the Chicago infant mortality study.

Organ weights are a possible diagnostic or pathophysiological clue to distinguishing sudden infant death syndrome (SIDS) cases from other infant deaths but suffer from major confounding. Using autopsy data from the Chicago Infant Mortality Study, a majority African-American case-control study of deceased infants under 1 year conducted 1993-96, we assessed differences in the weights of brain, thymus, kidneys, lungs, liver, spleen, total body, and four length anthropometry measures in SIDS-diagnosed infants compared to controls. Using exact and coarsened matching, we ran Bayesian linear models w

The role of environmental sensitivity in the mental health of Syrian refugee children: a multi-level analysis.

Individuals with high environmental sensitivity have nervous systems that are disproportionately receptive to both the protective and imperilling aspects of the environment, suggesting their mental health is strongly context-dependent. However, there have been few consolidated attempts to examine putative markers of sensitivity, across different levels of analysis, within a single cohort of individuals with high-priority mental health needs. Here, we examine psychological (self-report), physiological (hair hormones) and genetic (polygenic scores) markers of sensitivity in a large cohort of 159