Long-term safety and effectiveness of berotralstat for hereditary angioedema: The open-label APeX-S study.

Background: Berotralstat (BCX7353) is an oral, once-daily inhibitor of plasma kallikrein recently approved for prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE). The objective of this report is to summarize results from an interim analysis of an ongoing long-term safety study of berotralstat in patients with HAE.

Methods: APeX-S is an ongoing, phase 2, open-label study conducted in 22 countries (ClinicalTrials.

Clinical indications for image-guided interventional procedures in the musculoskeletal system: a Delphi-based consensus paper from the European Society of Musculoskeletal Radiology (ESSR)-part IV, hip.

Objectives: Image-guided musculoskeletal interventional procedures around the hip are widely used in daily clinical practice. The need for clarity concerning the actual added value of imaging guidance and types of medications to be offered led the Ultrasound and the Interventional Subcommittees of the European Society of Musculoskeletal Radiology (ESSR) to promote, with the support of its Research Committee, a collaborative project to review the published literature on image-guided musculoskeletal interventional procedures in the lower limb in order to derive a list of clinical indications.

Methods: In this article, we report the results of a Delphi-based consensus of 53 experts who reviewed the published literature for evidence on image-guided interventional procedures offered in the joint and soft tissues around the hip in order of their clinical indications.

Towards Detecting Pneumonia Progression in COVID-19 Patients by Monitoring Sleep Disturbance Using Data Streams of Non-Invasive Sensor Networks.

Pneumonia caused by COVID-19 is a severe health risk that sometimes leads to fatal outcomes. Due to constraints in medical care systems, technological solutions should be applied to diagnose, monitor, and alert about the disease's progress for patients receiving care at home. Some sleep disturbances, such as obstructive sleep apnea syndrome, can increase the risk for COVID-19 patients.

Citizen Consultation on Problematic Usage of the Internet: Ethical Considerations and Empirical Insights From Six Countries.

Citizens and scientists can work together to improve the collective well-being, if citizens are inspired to help the advancement of science, and researchers motivated to listen to the voices of citizens. The benefits of such collaboration are increasingly recognized by both citizens and scientists, as reflected in the growing number of related publications and initiatives. This is especially relevant for emerging areas of research, where early involvement of citizens could help to envision, prioritize, and plan prospective studies.

A Fast Transform for Brain Connectivity Difference Evaluation.

Anatomical and dynamical connectivity are essential to healthy brain function. However, quantifying variations in connectivity across conditions or between patient populations and appraising their functional significance are highly non-trivial tasks. Here we show that link ranking differences induce specific geometries in a convenient auxiliary space that are often easily recognisable at mere eye inspection.

Pleuropulmonary blastoma in children and adolescents: The EXPeRT/PARTNER diagnostic and therapeutic recommendations.

Pleuropulmonary blastoma (PPB) is a rare cancer occurring mainly during early childhood and often associated with germline DICER1 mutations. It is classified by the macroscopic appearance into three interrelated clinico-pathologic entities on a developmental continuum. Complete tumor resection is a main prognostic factor and can be performed at diagnosis or after neoadjuvant treatment that includes chemotherapy and in some cases radiotherapy.

An Early Stage Researcher's Primer on Systems Medicine Terminology.

Systems Medicine is a novel approach to medicine, that is, an interdisciplinary field that considers the human body as a system, composed of multiple parts and of complex relationships at multiple levels, and further integrated into an environment. Exploring Systems Medicine implies understanding and combining concepts coming from diametral different fields, including medicine, biology, statistics, modeling and simulation, and data science. Such heterogeneity leads to semantic issues, which may slow down implementation and fruitful interaction between these highly diverse fields.

Challenging Treatment of a Female Patient with Extensive Fournier's Gangrene - Case Report.

Fournier's gangrene (FG) is a necrotizing fasciitis of the genital, perianal and perineal regions, caused by multiple anaerobic/aerobic infection. It is a rare but very serious condition with multiple long-term complications and high mortality rate. Early diagnosis and multidisciplinary approach in treatment of complicated cases of FG are crucial to the successful outcome.

Guidelines for Editing Biomedical Journals: Recommended by Academy of Medical Sciences of Bosnia and Herzegovina.

Background: Enormous number of medical journals published around the globe requires standardization of editing practice.

Objective: The aim of this article was to enlist main principles of editing biomedical scientific journals adopted at annual meeting of Academy of Medical Sciences of Bosnia & Herzegovina (AMSB&H).

Methods: The evidence for writing this Guideline was systematically searched for during September 2020 in the PUBMED and GOOGLE SCHOLAR databases.

Balkan Clinical Research Registry: Established by Academy of Medical Sciences of Bosnia and Herzegovina.

Background: From 2013 the World Medical Association's Declaration of Helsinki explicitly requires pre-registration of a study involving human subjects. The registration gives a chance for improvement of design and avoidance of bias.

Objective: The aim of this article was to describe process of bearing decision to create regional registry of clinical studies for Balkan countries.

Prevalence of and factors affecting otitis media with effusion in children in the region from Balkans to Caspian basin; A multicentric cross-sectional study.

Objective: The aim of our study was to contribute to the literature about the prevalence of OME by conducting a research in a wide geography examining most of the associating factors together with a questionnaire. Additionally, possible effects of altitudes and latitudes, concordance between the otoscopic examination findings and tympanometric and acoustic reflex test results were evaluated in 4-7 years old children in the same season in different countries.

Methods: In the randomly sampled schools from different regions of different cities where people of different scoioecomonic statuses live, 4-7 year-old children were included in the study.

CYP3A7*1C allele: linking premenopausal oestrone and progesterone levels with risk of hormone receptor-positive breast cancers.

Background: Epidemiological studies provide strong evidence for a role of endogenous sex hormones in the aetiology of breast cancer. The aim of this analysis was to identify genetic variants that are associated with urinary sex-hormone levels and breast cancer risk.

Methods: We carried out a genome-wide association study of urinary oestrone-3-glucuronide and pregnanediol-3-glucuronide levels in 560 premenopausal women, with additional analysis of progesterone levels in 298 premenopausal women.

Mid-infrared spectroscopy as process analytical technology tool for estimation of THC and CBD content in Cannabis flowers and extracts.

Tetrahydrocannabinol (THC) and cannabidiol (CBD) are the most notable Cannabis components with pharmacological activity and their content in the plant flowers and extracts are considered as critical quality parameters. The new Medical Cannabis industry needs to adopt the quality standards of the pharmaceutical industry, however, the variability of phytocannabinoids content in the plant material often exerts an issue in the inconsistency of the finished product quality parameters. Sampling problems and sample representativeness is a major limitation in the end-point testing, particularly when the expected variation of the product quality parameters is high.

Coupling between Blood Pressure and Subarachnoid Space Width Oscillations during Slow Breathing.

The precise mechanisms connecting the cardiovascular system and the cerebrospinal fluid (CSF) are not well understood in detail. This paper investigates the couplings between the cardiac and respiratory components, as extracted from blood pressure (BP) signals and oscillations of the subarachnoid space width (SAS), collected during slow ventilation and ventilation against inspiration resistance. The experiment was performed on a group of 20 healthy volunteers (12 females and 8 males; BMI=22.

Brucellosis in pregnancy: case reports with different outcomes in an endemic region.

Different outcomes of brucellosis in pregnancy regarding the fetus/neonate and the mother are described. Medical records of five pregnant women with brucellosis were retrospectively analyzed. Patients were treated in several departments of infectious diseases in the Republic of Macedonia between 1995 and 2009.

The Functional Availability of Arterial Kv7 Channels Is Suppressed Considerably by Large-Conductance Calcium-Activated Potassium Channels in 2- to 3-Month Old but Not in 10- to 15-Day Old Rats.

Background: Voltage-gated potassium (Kv) channels, especially Kv7 channels, are major potassium channels identified in vascular smooth muscle cells with a great, albeit differential functional impact in various vessels. Vascular smooth muscle Kv7 channels always coexist with other K channels, in particular with BK channels. BK channels differ in the extent to which they influence vascular contractility.

Network Physiology of Exercise: Vision and Perspectives.

The basic theoretical assumptions of Exercise Physiology and its research directions, strongly influenced by reductionism, may hamper the full potential of basic science investigations, and various practical applications to sports performance and exercise as medicine. The aim of this perspective and programmatic article is to: (i) revise the current paradigm of Exercise Physiology and related research on the basis of principles and empirical findings in the new emerging field of Network Physiology and Complex Systems Science; (ii) initiate a new area in Exercise and Sport Science, Network Physiology of Exercise (NPE), with focus on basic laws of interactions and principles of coordination and integration among diverse physiological systems across spatio-temporal scales (from the sub-cellular level to the entire organism), to understand how physiological states and functions emerge, and to improve the efficacy of exercise in health and sport performance; and (iii) to create a forum for developing new research methodologies applicable to the new NPE field, to infer and quantify nonlinear dynamic forms of coupling among diverse systems and establish basic principles of coordination and network organization of physiological systems. Here, we present a programmatic approach for future research directions and potential practical applications.

Is there an association between paternal age and aneuploidy? Evidence from young donor oocyte-derived embryos: a systematic review and individual patient data meta-analysis.

Background: Delayed parenthood, by both women and men, has become more common in developed countries. The adverse effect of advanced maternal age on embryo aneuploidy and reproductive outcomes is well known. However, whether there is an association between paternal age (PA) and embryonic chromosomal aberrations remains controversial.

Impact of COVID-19 pandemic and diabetes on mechanical reperfusion in patients with STEMI: insights from the ISACS STEMI COVID 19 Registry.

Background: It has been suggested the COVID pandemic may have indirectly affected the treatment and outcome of STEMI patients, by avoidance or significant delays in contacting the emergency system. No data have been reported on the impact of diabetes on treatment and outcome of STEMI patients, that was therefore the aim of the current subanalysis conducted in patients included in the International Study on Acute Coronary Syndromes-ST Elevation Myocardial Infarction (ISACS-STEMI) COVID-19.

Methods: The ISACS-STEMI COVID-19 is a retrospective registry performed in European centers with an annual volume of > 120 primary percutaneous coronary intervention (PCI) and assessed STEMI patients, treated with primary PCI during the same periods of the years 2019 versus 2020 (March and April).

Myocardial Infarction in Systemic Lupus Erythematosus - the Sex-Specific Risk Profile.

Background: Accelerated atherosclerosis is widely present in patients with systemic lupus erythematosus.

Objective: The aim of this review was to analyze the relationship between systemic lupus erythematosus and cardiovascular diseases, with the emphasis on acute myocardial infarction.

Methods: We conducted a literature review through PubMed and Cochrane, using keywords: SLE, atherosclerosis, atherothrombosis, coronary artery disease, myocardial infarction, prognosis, sex specifics.

Impact of COVID-19 Pandemic on Mechanical Reperfusion for Patients With STEMI.

Background: The fear of contagion during the coronavirus disease-2019 (COVID-19) pandemic may have potentially refrained patients with ST-segment elevation myocardial infarction (STEMI) from accessing the emergency system, with subsequent impact on mortality.

Objectives: The ISACS-STEMI COVID-19 registry aims to estimate the true impact of the COVID-19 pandemic on the treatment and outcome of patients with STEMI treated by primary percutaneous coronary intervention (PPCI), with identification of "at-risk" patient cohorts for failure to present or delays to treatment.

Methods: This retrospective registry was performed in European high-volume PPCI centers and assessed patients with STEMI treated with PPPCI in March/April 2019 and 2020.