Imaging Advances in Heart Failure.

This paper delves into the significance of imaging in the diagnosis, aetiology and therapeutic guidance of heart failure, aiming to facilitate early referral and improve patient outcomes. Imaging plays a crucial role not only in assessing left ventricular ejection fraction, but also in characterising the underlying cardiac abnormalities and reaching a specific diagnosis. By providing valuable data on cardiac structure, function and haemodynamics, imaging helps diagnose the condition, evaluate haemodynamic status and, consequently, identify the underlying pathophysiological phenotype, as well as stratifying the risk for outcomes.

Professional health of instructor-officers with different service experience.

Objective: Aim: To investigate the levels and indicators of professional deformation in instructor-officers with different service experience as a negative factor in their professional health.

Patients And Methods: Materials and Methods: The research, which was conducted in 2022-2023, involved 136 instructor-officers of the National Academy of Internal Affairs aged 25-55 years with different service experience (up to 5 years - 21 people, 5-10 years - 45 people, 10-15 years - 42 people, over 15 years - 28 people).

Results: Results: The dynamics of the levels of professional deformation in instructor-officers of higher educational institutions depending on the experience of their service activities have been determined, and the peculiarities of the manifestation of key professional and psychological indicators that affect their professional health in the course of their service activities have been revealed.

Motivational orientations of students towards internet dependent behavior and measures for its prevention.

Objective: Aim: The aim is to study the motivation of students towards Internet dependent behavior and develop practical recommendations for improving a set of measures for its prevention.

Patients And Methods: Materials and Methods: The research involved 154 students of the National Academy of Internal Affairs. Research methods: analysis and generalization of literature sources, questionnaire, statistical methods.

HEPATITIS A. THE FEATURES OF DISEASE COURSE IN ADULTS.

Objective: The aim: To analyze the incidence of Hepatitis A in Ukraine and Poltava region and to study the clinical and epidemiological features of the course of Hepatitis A in adult patients.

Patients And Methods: Materials and methods: The course of HA in 96 hospitalized patients was analyzed. The diagnosis of HA was established on the basis of clinical and epide¬miological data and confirmed by the results of laboratory studies (serological and molecular biological).

Tumor-Agnostic Approvals: Insights and Practical Considerations.

Since the first approval of a tumor-agnostic indication in 2017, a total of seven tumor-agnostic indications involving six drugs have received approval from the FDA. In this paper, the master protocol subteam of the Statistical Methods in Oncology Scientific Working Group, Biopharmaceutical Session, American Statistical Association, provides a comprehensive summary of these seven tumor-agnostic approvals, describing their mechanisms of action; biomarker prevalence; study design; companion diagnostics; regulatory aspects, including comparisons of global regulatory requirements; and health technology assessment approval. Also discussed are practical considerations relating to the regulatory approval of tumor-agnostic indications, specifically (i) recommendations for the design stage to mitigate the risk that exceptions may occur if a treatment is initially hypothesized to be effective for all tumor types and (ii) because drug development continues after approval of a tumor-agnostic indication, recommendations for further development of tumor-specific indications in first-line patients in the setting of a randomized confirmatory basket trial, acknowledging the challenges in this area.

Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned.

Despite increasing utilization of real-world data (RWD)/real-world evidence (RWE) in regulatory submissions, their application to oncology drug approvals has seen limited success. Real-world data is most commonly summarized as a benchmark control for a single arm study or used to augment the concurrent control in a randomized clinical trial (RCT). While there has been substantial research on usage of RWD/RWE, our goal is to provide a comprehensive overview of their use in oncology drug approval submissions to inform future RWD/RWE study design.

Integrating de novo and inherited variants in 42,607 autism cases identifies mutations in new moderate-risk genes.

To capture the full spectrum of genetic risk for autism, we performed a two-stage analysis of rare de novo and inherited coding variants in 42,607 autism cases, including 35,130 new cases recruited online by SPARK. We identified 60 genes with exome-wide significance (P < 2.5 × 10), including five new risk genes (NAV3, ITSN1, MARK2, SCAF1 and HNRNPUL2).

Women leaders in Cardiology. Contemporary profile of the WHO European region.

Aims: Women's participation is steadily growing in medical schools, but they are still not sufficiently represented in cardiology, particularly in cardiology leadership positions. We present the contemporary distribution of women leaders in cardiology departments in the World Health Organization European region.

Methods And Results: Between August and December 2020, we applied purposive sampling to collect data and analyse gender distribution of heads of cardiology department in university/third level hospitals in 23 countries: Austria, Azerbaijan, Belgium, Bosnia-Herzegovina, Croatia, France, Germany, Greece, Italy, North Macedonia, Morocco, Poland, Portugal, Russia, Serbia, Slovakia, Slovenia, Spain, Switzerland, Tunisia, Turkey, Ukraine, and the UK.

Statistical and Operational Considerations for 2-Stage Adaptive Designs with Simultaneous Evaluation of Overall and Marker-Selected Populations in Oncology Confirmatory Trials.

In biomarker enrichment study designs that start with an all-comer population, simultaneous evaluation of the entire and the marker-selected populations can be more desirable than pre-specifying the testing order, when the degree of marker predictiveness is uncertain. While there has been substantial research on this approach, our goal is to provide a complete overview and guidance in all aspects of this approach, including the interim analysis potentially using different endpoints, combination tests with associated multiplicity control, and the final treatment effect estimation. Regulatory/operational aspects and actual cases demonstrating the potential advantage of this approach are also described.

Accuracy and Safety of Novel Designs for Phase I Drug-Combination Oncology Trials.

Despite numerous innovative designs having been published for phase I drug-combination dose finding trials, their use in real applications is rather limited. As a working group under the American Statistical Association Biopharmaceutical Section, our goal is to identify the unique challenges associated with drug combination, share industry's experiences with combination trials, and investigate the pros and cons of the existing designs. Toward this goal, we review seven existing designs and distinguish them based on the criterion of whether their primary objectives are to find a single maximum tolerated dose (MTD) or the MTD contour (i.

DIAGNOSTIC VALUE OF GLOBAL LONGITUDINAL STRAIN IN PATIENTS WITH CORONARY ARTERY DISEASE.

Objective: The aim: To investigate the global longitudinal strain (GLS) in patients with preserved left ventricle systolic function and the presence of varying degrees of coronary artery disease.

Patients And Methods: Materials and methods: The study is based on data obtained during a prospective analysis of 131 patients aged 51 to 82 years in the period from January to December 2019,whose complaints indicate coronary heart disease. The main instrumental method of examination was coronary angiography, patients were divided into 3 groups according to the results.

REVISITING THE VALUE OF HAEMATOLOGICAL AND BIOCHEMICAL MARKERS AND THE RATIOS IN PATIENTS WITH CORONARY ARTERY DISEASE.

Objective: The aim: To investigate haematological and biochemical parameters and their potential for grading the severity of coronary artery lesions to predict the course atherosclerosis.

Patients And Methods: Materials and methods: The study is based on data obtained from a prospective analysis of 131 patients at the age of 51 to 82 years old from January to December 2019, whose complaints could indicate the coronary artery disease. All patients underwent a comprehensive clinical, laboratory and instrumental examination.

Women's perspective on the COVID-19 pandemic: Walking into a post-peak phase.

The pandemic of Novel Coronavirus Disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has provoked hundreds of thousands of deaths, resulting in catastrophe for humans. Although some insights have been garnered in studies on women, children and young adults infected with COVID-19, these often remain fragmented in literature. Therefore, we discussed the impact of COVID-19 pandemic on women, children and young patients, particularly those with underlying cardiovascular comorbidities or congenital heart disease.

[MULTI-FACTOR MODEL OF FINANCING PREVENTION AND TREATMENT OF DIROPHILARIOSIS (BASIC PRINCIPLES AND INDICATORS OF EFFICIENCY)].

The aim of the study was to substantiate the effectiveness and feasibility of the practical application of the multifactorial model of financing the prevention and treatment of dirofilariasis, its principles and methodological approaches. The basic principles of the multifactor model - an integrated approach, a combination of public and private financing, ensuring continuity of financing, discreteness of expenses; methodology for determining the effectiveness of the use of financial resources on the calculation of the return on costs for the prevention and treatment of dirofilariasis were justified. The effectiveness of local budget spending on the treatment of territories of the Kharkov region from mosquitoes on the base on the proposed principles and methodology was analyzed.

[COMPARATIVE ANALYSIS OF THE COST OF TREATMENT OF ECHINOCOCCOSIS BY THERAPEUTIC AND SURGICAL METHODS (BASED ON THE STEP-DOWN METHODOLOGY)].

The aim of the study was to carry out a comparative economic analysis of the costs of therapeutic and surgical treatment of liver echinococcosis based on the developed methodological approaches and principles for calculating the cost of complex medical services in accordance with the «step-down» methodology. The model for calculating the cost of complex medical services for the treatment of echinococcosis was justified. The sum of costs of outpatient and inpatient units that directly provide medical care (direct costs) to the costs of support centers (indirect costs) was adjusted, which among simple medical services based on the chosen criterion were distributed.

TLR4 and TLR7 genetic polymorphism in patients with HIV/HCV-coinfection: prevalence and gender-related features.

Objective: Introduction: HIV-infection and chronic hepatitis C is of great concern of current infectology. The paper is aimed at the study of the prevalence of the of TLR4 gene Gly and TLR7 gene Leu polymorphic alleles among patients with HIV/HCV-coinfection in general and with regard to gender, as well as to determine their role in the development of the infection.

Patients And Methods: Materials and methods: To achieve the objective of the research a cohort and case-control study has been carried out.

[THE ITERATIVE APPROACH TO PRICING LABORATORY SERVICES FOR THE PROVISION OF MEDICAL AID (COPROPROCYCOSOPHICAL EXAMINATION ON LYAMBLIOSIS)].

The purpose of the study was to substantiate the theoretical and methodical principles of pricing for laboratory services in the diagnosis of giardiasis, taking into account their iterability and peculiarities of parasitic research methods. The methods of laboratory study of gum disease of native smear, treated with Lyulol solution, and ether-formalin enrichment on the criteria of their quality and effectiveness are analyzed. On the basis of the study of the effectiveness of the first and repeated analyzes, the conclusion on the iterative nature of laboratory studies of giardiasis and the effectiveness of the use of an iterative approach to the determination of prices for laboratory services is substantiated.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Transforming Data Into Evidence.

Background: Safety evaluation is a key aspect of medical product development. It is a continual and iterative process requiring thorough thinking, and dedicated time and resources.

Methods: In this article, we discuss how safety data are transformed into evidence to establish and refine the safety profile of a medical product, and how the focus of safety evaluation, data sources, and statistical methods change throughout a medical product's life cycle.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Clinical Trials.

Background: There has been an increased emphasis on the proactive and comprehensive evaluation of safety endpoints to ensure patient well-being throughout the medical product life cycle. In fact, depending on the severity of the underlying disease, it is important to plan for a comprehensive safety evaluation at the start of any development program. Statisticians should be intimately involved in this process and contribute their expertise to study design, safety data collection, analysis, reporting (including data visualization), and interpretation.

Sources of Safety Data and Statistical Strategies for Design and Analysis: Real World Insights.

Background: Although randomized controlled clinical trials provide necessary information and serve as the basis for regulatory decision making, a significant gap exists between the evidence these trials provide and what the biomedical community needs. It is recognized that a wealth of data are routinely collected outside clinical trials. Such real-world data (RWD) are not of comparable quality, it does not have similar immunity from bias and confounding as data collected in randomized clinical trials, but it might offer additional understanding of the benefit-risk, provide new insights to different stakeholders, and aid in regulatory decision making.

Alkylthiol self-assembled monolayers on Au(111) with tailored tail groups for attaching gold nanoparticles.

Self-assembled monolayers (SAMs) on Au(111) are able to control the functionality of a gold surface. We use scanning tunnelling microscopy (STM) in air and contact angle measurements to compare the morphology and the chemistry of three alkylthiol SAMs differing by their tail groups: 1,9-nonanedithiol (NDT), 1,4-butanedithiol (BDT) and 11-mercaptoundecanol (MUOH). STM reveals very different morphologies: a hexagonal lattice for MUOH and parallel rows for NDT and BDT.