A Descriptive Comparative Analysis of Safety Concerns Outlaid in the Risk Management Plans of the European Union and Japan.

Purpose: This study aimed to obtain a better understanding of the characteristics of the risk management plans (RMP) and the background regulatory policies governing them, in the European Union (EU) and Japan. This was done by descriptively comparing the safety concerns (SCs) listed in the RMP and examining their relationships with product labeling.

Methods: Information regarding SCs was collected from the published RMP of both the EU and Japan for the targeted products-all of which were commonly approved in both regions.

Zero-echo time imaging achieves whole brain activity mapping without ventral signal loss in mice.

Functional MRI (fMRI) is an important tool for investigating functional networks. However, the widely used fMRI with T2*-weighted imaging in rodents has the problem of signal lack in the lateral ventral area of forebrain including the amygdala, which is essential for not only emotion but also noxious pain. Here, we scouted the zero-echo time (ZTE) sequence, which is robust to magnetic susceptibility and motion-derived artifacts, to image activation in the whole brain including the amygdala following the noxious stimulation to the hind paw.

Pitting base rate driven heuristics against conditional reasoning in multivariate contingency assessment.

Contingency assessment is a major module of adaptive cognition and a prominent topic of ecological rationality. Virtually all influential theories assume that contingency estimates between Y and X are inferred from subjective conditional probabilities of focal Y levels given different X levels, p ( Y focal | X different levels ) . Yet, conditional probabilities are cognitively demanding, as Yfocal must be assessed separately for all levels of Xdifferent level.

PARADIGM-PV: a randomized, multicenter phase 4 study to assess the efficacy and safety of ropeginterferon alfa-2b in patients with low- or high-risk polycythemia vera.

Polycythemia vera (PV) is characterized by clonal hematopoietic stem or progenitor cells with constitutively active somatic mutation(s) in the Janus kinase 2 gene. Phlebotomy (Phl) and aspirin are often used alone for low-risk PV patients. However, data from the Low-PV study demonstrated that Phl and aspirin may not be adequate for patients.

Real-time detection of somatostatin release from single islets reveals hypersecretion in type 2 diabetes.

Aim: Somatostatin from pancreatic δ-cells is a paracrine regulator of insulin and glucagon secretion, but the release kinetics and whether secretion is altered in diabetes is unclear. This study aimed to improve understanding of somatostatin secretion by developing a tool for real-time detection of somatostatin release from individual pancreatic islets.

Methods: Reporter cells responding to somatostatin with cytoplasmic Ca concentration ([Ca]) changes were generated by co-expressing somatostatin receptor SSTR2, the G-protein Gα15 and a fluorescent Ca sensor in HeLa cells.

Cost-Effectiveness of the Self-Care Management System for Heart Failure.

Background: We recently reported that the self-care management system for heart failure (HF) decreased re-hospitalization for HF. In the present study we estimate the cost-effectiveness of this system.

Methods And Results: We retrospectively enrolled 569 consecutive patients who were admitted for HF treatment at Kitano Hospital.

Disease activity and glucocorticoid tapering patterns in Japanese patients with systemic lupus erythematosus treated with anifrolumab: post hoc analysis of the Japanese subpopulation of the TULIP-2 study.

Objectives: To investigate the efficacy of anifrolumab on disease activity and glucocorticoid tapering patterns in Japanese patients with systemic lupus erythematosus (SLE).

Methods: We analysed disease activity and glucocorticoid tapering in the Japanese subpopulation (anifrolumab, n = 24; placebo, n = 19) of the TULIP-2 trial, which showed the efficacy and safety of anifrolumab in patients with moderate-to-severe active SLE.

Results: The percentage of patients who achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment response at Week 52 was greater in the anifrolumab group than placebo [50.

The Efficacy and Safety of Angiotensin II for Treatment of Vasoplegia in Critically Ill Patients: A Systematic Review.

Objectives: To summarize evidence regarding intravenous angiotensin II administration in critical illness and provide an updated understanding of its effects on various organ dysfunction and renin-angiotensin system (RAS) biomarkers.

Design: A systematic review.

Setting: A search of PubMed, Embase, and the Cochrane Library from inception to May 3, 2024.

The impact of hypertension prevention and modification on dementia burden: A systematic review of economic studies.

Aim: Neurological disorders account for the largest proportion of disability-adjusted life years globally, with dementia being the third leading cause. Hypertension has been identified as a priority, targetable risk factor for dementia. This study aimed to systematically review economic studies that examine the impact of hypertension prevention and control on the costs and outcomes of dementia.

Transforming cancer screening: the potential of multi-cancer early detection (MCED) technologies.

Early cancer detection substantially improves the rate of patient survival; however, conventional screening methods are directed at single anatomical sites and focus primarily on a limited number of cancers, such as gastric, colorectal, lung, breast, and cervical cancer. Additionally, several cancers are inadequately screened, hindering early detection of 45.5% cases.

Urban-rural disparities in cervical cancer screening among Indian women between 30-49 years: a geospatial and decomposition analysis using a nationally representative survey.

Introduction: Existing evidence suggests a lower uptake of cervical cancer screening among Indian women. Coverage is lower in rural than urban women, but such disparities are less explored. So, the present study was conducted to explore the self-reported coverage of cervical cancer screening in urban and rural areas stratified by socio-demographic characteristics, determine the spatial patterns and identify any regional variations, ascertain the factors contributing to urban-rural disparities and those influencing the likelihood of screening among women aged 30-49 years factors residing in urban, rural, and overall Indian settings.

The Impact of Diabetes Mellitus and Metformin Use on Outcomes After Endovascular Aneurysm Repair.

: To study the influence of diabetes mellitus (DM) and metformin treatment on aneurysm sac remodeling after endovascular aneurysm repair (EVAR). : A retrospective single-center cohort analysis was conducted on consecutive patients who underwent elective EVAR for an infrarenal abdominal aortic aneurysm (AAA) between January 2011 and December 2021. Differences between study groups were analyzed and Kaplan-Meier analysis were employed to describe overall and reintervention-free survival.

Characteristics of Gastrointestinal Bleeding While Taking Direct Oral Anticoagulants in Patients with Nonvalvular Atrial Fibrillation and Differences Among Drugs-A Single-Center Retrospective Cohort Study.

: Direct oral anticoagulants (DOACs) are frequently used to prevent embolism in atrial fibrillation. Gastrointestinal bleeding is frequent, but its drug-specific characteristics remain unclear. This study examined the frequency and characteristics of gastrointestinal bleeding in patients with nonvalvular atrial fibrillation for different DOACs.

Monitoring a Railway Bridge with Distributed Fiber Optic Sensing Using Specially Installed Fibers.

This article explores the use of distributed fiber optic sensing (DFOS) technology in monitoring civil infrastructure, with a concrete example of an elevated railway bridge in Taiwan. The field test utilized multiple strain-sensing fibers attached to a 1 km span of a bullet train railway bridge, which were combined to calculate the 3-dimensional bridge deformation. The installed sensing system and continuous measurements enabled quick safety confirmation after earthquakes of Richter scale 6.

A first-in-human phase 1/2 dose-escalation study of MAK683 (EED inhibitor) in patients with advanced malignancies.

Purpose: MAK683, a first-in-class and highly selective allosteric inhibitor of the embryonic ectoderm development subunit of polycomb repressive complex 2, has shown sustained antitumor activity in tumor xenograft models. This first-in-human phase 1/2 study evaluated the safety, pharmacokinetics (PK), and clinical activity of single-agent MAK683 in advanced malignancies.

Methods: MAK683 was administered fasted once daily or twice daily continuously in 28-day treatment cycles.

A national survey of career development according to gender and subspecialties among cardiologists in Japan.

Background: Training opportunities, work satisfaction, and the factors that influence them according to gender and subspecialties are understudied among Japanese cardiologists.

Methods: We investigated the career development of Japanese cardiologists with an e-mail questionnaire. Feelings of inequality in training opportunities, work dissatisfaction, and reasons were assessed by examining the cardiologists' gender and invasiveness of subspecialties.

A protocol to study the effect of targeted parental education intervention to identify early childhood development disorder - multisite interventional study.

Background: In India, approximately 3.5 million children are affected by Developmental Delay (DD), often stemming from preterm births. These delays contribute to neurological and motor development delays, placing a significant financial burden on families.

Investigation of the association between therapeutic effectiveness of anamorelin and Glasgow prognostic score in patients with cancer cachexia: a competing risk analysis.

Anamorelin, a highly selective ghrelin receptor agonist, enhances appetite and increases lean body mass in patients with cancer cachexia. However, the predictors of its therapeutic effectiveness are uncertain. This study aimed to investigate the association between the Glasgow prognostic score (GPS), used for classifying the severity of cancer cachexia, the therapeutic effectiveness of anamorelin, and the feasibility of early treatment based on cancer types.

Identification of key gene signatures for predicting chemo-immunotherapy efficacy in extensive-stage small-cell lung cancer using machine learning.

Objectives: The lack of definitive biomarkers presents a significant challenge for chemo-immunotherapy in extensive-stage small-cell lung cancer (ES-SCLC). We aimed to identify key genes associated with chemo-immunotherapy efficacy in ES-SCLC through comprehensive gene expression analysis using machine learning (ML).

Methods: A prospective multicenter cohort of patients with ES-SCLC who received first-line chemo-immunotherapy was analyzed.

Improving Recall Accuracy in Sparse Associative Memories That Use Neurogenesis.

The creation of future low-power neuromorphic solutions requires specialist spiking neural network (SNN) algorithms that are optimized for neuromorphic settings. One such algorithmic challenge is the ability to recall learned patterns from their noisy variants. Solutions to this problem may be required to memorize vast numbers of patterns based on limited training data and subsequently recall the patterns in the presence of noise.

Uncovering Dynamical Equations of Stochastic Decision Models Using Data-Driven SINDy Algorithm.

Decision formation in perceptual decision making involves sensory evidence accumulation instantiated by the temporal integration of an internal decision variable toward some decision criterion or threshold, as described by sequential sampling theoretical models. The decision variable can be represented in the form of experimentally observable neural activities. Hence, elucidating the appropriate theoretical model becomes crucial to understanding the mechanisms underlying perceptual decision formation.

Arterial Thromboembolism in Patients With Advanced Lung Cancer: Secondary Analyses of the Rising-VTE/NEJ037 Study.

Background: Cancer-associated thromboembolism has been thoroughly investigated in previous studies, and direct oral anticoagulants (DOACs) were established for the treatment and prevention of venous thromboembolism (VTE). However, the risks of cancer-associated arterial thromboembolism (ATE) and the efficacy of DOACs remain unclear.

Objectives: To evaluate the risk factors and the clinical activity of edoxaban (EDO) for the prevention of ATE in patients with advanced lung cancer.

Combination Antithrombotic Therapy for Reduction of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease.

Background: Stroke secondary to intracranial atherosclerotic disease (ICAD) is associated with high recurrence risk despite currently available secondary prevention strategies. In patients with systemic atherosclerosis, a significant reduction of stroke risk with no increase in intracranial or fatal hemorrhage was seen when rivaroxaban 2.5 mg twice daily was added to aspirin.

Marine-Derived Compound Targeting mTOR and FGFR-2: A Promising Strategy for Breast, Lung, and Colorectal Cancer Therapy.

Introduction: The marine habitat is a plentiful source of diverse, active compounds that are extensively utilised for their medicinal properties. Pharmaceutical trends have currently changed towards utilising a diverse range of goods derived from the marine environment.

Method: This study aimed to examine the inhibitory effects of bioactive chemicals derived from marine algae and bacteria.