Prevalence of Borrelia burgdorferi sensu lato infection in the Czech Republic.

Introduction: Lyme borreliosis (LB), an infection caused by Borrelia burgdorferi sensu lato (Bbsl), is the most common tick-borne disease in Europe. To further characterize the LB burden in the Czech Republic, we conducted a seroprevalence study and estimated the incidence of symptomatic Bbsl infections.

Methods: Anti-Bbsl IgM and IgG antibodies were detected in sera collected from the adult population in 2011 -2012 by enzyme-linked immunosorbent assay and immunoblot tests at the National Reference Laboratory.

Aryl Hydrocarbon Receptor Pathway Augments Peritoneal Fibrosis in a Murine CKD Model Exposed to Peritoneal Dialysate.

Key Points: CKD and high glucose–containing peritoneal dialysate alter peritoneal membrane contributing to peritoneal dialysis failure, with a poorly understood mechanism. CKD milieu activates the aryl hydrocarbon receptor pathway in the subperitoneal vasculature, increasing the peritoneal fibrosis and collagen deposition in humans and mice. An aryl hydrocarbon receptor inhibitor mitigates CKD and peritoneal dialysis–mediated peritoneal fibrosis, collagen deposition, and vasculogenesis in a mouse model.

End Organ Affection in Sickle Cell Disease.

Sickle cell disease is an orphan disease affecting ethnic minorities and characterized by profound systemic manifestations. Although around 100,000 individuals with SCD are living in the US, the exact number of individuals is unknown, and it is considered an orphan disease. This single-gene disorder leads to red blood cell sickling and the deoxygenation of hemoglobin, resulting in hemolysis.

Evaluation of Computerized Tomography Utilization in Comparison to Digital Subtraction Angiography in Patients with Peripheral Arterial Disease.

Background: Perform literature review to analyze current practices in imaging patient with peripheral arterial disease (PAD) and examine patterns in our practice in order to assess whether a lower extremity computed tomography angiography (CTA) in addition to digital subtraction angiography enhanced the assessment of vessel calcification, percentage of stenosis, and affected outcomes in patients with PAD.

Methods: The study included patients who underwent lower extremity imaging and were followed up to 12 months. This population was divided into cases who had both an angiogram and CTA performed within 30 days (n = 20), and controls who underwent angiography only (n = 19).

Impact of institutional review board stipulations on turnaround time for approvals of surgical studies.

Background: We have examined the number and types of stipulations received following the submission of surgical study protocols to the Institutional Review Boards (IRBs) for review, and their effect on turnaround time for approval. This analysis will enable our organization to improve the quality of applications and design of study protocols, which can streamline the approval process and increase efficiency of the startup phase for clinical research.

Methods: IRB stipulations for 48 surgical studies were analyzed.

The Use of Biomarkers in Pharmacovigilance: A Systematic Review of the Literature.

Background: The use of biomarkers varies from disease etiognosis and diagnosis to signal detection, risk prediction, and management. Biomarker use has expanded in recent years, however, there are limited reviews on the use of biomarkers in pharmacovigilance and specifically in the monitoring and management of adverse drug reactions (ADRs).

Objective: The objective of this manuscript is to identify the multiple uses of biomarkers in pharmacovigilance irrespective of the therapeutic area.

Assessment of the Relationship Between Protocol Adherence, Study Complexity and Personnel in Surgical Clinical Trials.

Background: In order to improve quality and efficiency of surgical trials, we assessed protocols complexity and examined whether it influenced the conduct, as measured by the number and types of deviations that occurred during the execution phase. Knowledge of these facts and performance of research team would allow to effectively mitigate the occurrence of deviations.

Methods: Thirty-five research protocols were rated according to a previously established complexity scoring model.

Carriage of Neisseria meningitidis in newly enlisted young military professionals during the COVID-19 pandemic.

Aim: Invasive meningococcal disease (IMD) is still a major threat not only to the youngest age group of children but also to adolescents and young adults. Higher rates of meningococcal disease have also been reported in specific at-risk groups, such as secondary and tertiary students and members of the military. Infection occurs after close contact with a clinically ill individual, but most often with an asymptomatic carrier.

Safety surveillance and challenges in accelerated COVID-19 vaccine development.

Unlabelled: The COVID-19 pandemic, caused by a novel type of coronavirus, continues to infect people, increasing morbidity and mortality across the globe. Measures to slow the transmission of the virus have had limited impact, and people, businesses, and economies have suffered. The disease has disproportionally impacted elderly and individuals with certain pre-existing conditions and has highlighted health and social inequities in some racial and ethnic minority groups.

Ectodermal dysplasia: important role of complex dental care in its interdisciplinary management.

Aim: Despite the fact that ectodermal dysplasia (ED) is a rare disease, it is often seen in a tertiary clinic. ED affects ectodermal tissues such as skin, hair, teeth, nails, and sweat glands. Patients usually have sparse light hair, deformed nails, and dry skin.

The structure and prebiotic activity of arabinogalactan from Ferula Kuhistаnica.

Acidic arabinogalactan with molecular weight 36 kDa was isolated from the aerial part of Ferula kuhistаnica, the monosaccharide composition of which is represented by galactose and arabinose in a ratio of 3.6:1. The chemical and spectral methods revealed a main polymer chain consisting of (1 → 6) β-galactopyranose residues, where in position of C-3 were the residues of α-arabinofuranose and its 1,5-linked oligomers, as well as β-GlcpA-4-OMe-(1 → 6)-β-Galp-(1→ fragments.

Steroid diagnostics of 21st century in the light of their new roles and analytical tools.

The determination of steroid hormones and subsequent interpretation of results is accompanied by a range of difficulties. The amount of information that current technology can provide on the circulating concentrations of more than a hundred various steroid compounds can lead to problems with interpretation. The aim of this study is to help provide orientation in this maze of data on steroid hormones.

Risk-Based Quality and Compliance Management in Clinical Trials with Combination Products in Changing Global Regulatory Environment.

Background: Newly emerging products which combine drugs, devices, and biologics are expected to provide new opportunities in bridging device and drug capabilities and establish synergies while bringing sophisticated combination products to consumers. The emergence of these novel products has triggered new regulatory, strategic, and technological challenges. While progress has been made at clarifying the issues that arise most frequently, regulatory authorities and product developers continue to struggle with complex regulatory and technical issues encompassing the development programs for combination products.

Practical applications of regulatory requirements for signal detection and communications in pharmacovigilance.

Pharmacovigilance is a field where communication is crucial, and exchange of information is expected to be done in a timely manner. Information from individual case reports is transmitted from pharmaceutical industry and health professionals to the regulatory authorities. The safety profile of a drug is established by analyzing individual cases and aggregate reports.

Inherited ichthyoses: molecular causes of the disease in Czech patients.

Inherited ichthyoses belong to a large and heterogeneous group of mendelian disorders of cornification, and can be distinguished by the quality and distribution of scaling and hyperkeratosis, by other dermatologic and extracutaneous involvement, and by inheritance. We present the genetic analysis results of probands with X-linked ichthyosis, autosomal recessive congenital ichthyosis, keratinopathic ichthyosis, and a patient with Netherton syndrome. Genetic diagnostics was complemented by in silico missense variant analysis based on 3D protein structures and commonly used prediction programs to compare the yields of these two approaches to each other.

Differential diagnosis of ascites in internal medicine: clinical case.

Ascites and hydrothorax may be the symptoms of congestive heart failure and do not always reflects presense of the decompensated liver cirrhosis. Clinical examination of patient with chronic hepatitis C which cyanosis of the lips, cervival veins pulsation, a triple heart rhythm indicated on pathology of the heart (constrictive pericarditis), which was confirmed by instrumental methods. Congestive heart failure has lead to the congestive liver in a young female patient.

Association of 17q24.2-q24.3 deletions with recognizable phenotype and short telomeres.

Microdeletions of 17q24.2-q24.3 have been described in several patients with developmental and speech delay, growth retardation, and other features.

Genome-wide uniparental diploidy of all paternal chromosomes in an 11-year-old girl with deafness and without malignancy.

Approximately 20 cases of genome-wide uniparental disomy or diploidy (GWUPD) as mosaicism have previously been reported. We present the case of an 11-year-old deaf girl with a paternal uniparental diploidy or isodisomy with a genome-wide loss of heterozygosity (LOH). The patient was originally tested for non-syndromic deafness, and the novel variant p.

A single center analysis of factors influencing study start-up timeline in clinical trials.

Aim: Efficient start-up phase in clinical trials is crucial to execution. The goal was to determine factors contributing to delays.

Materials & Methods: The start-up milestones were assessed for 38 studies and analyzed.

Evaluation of T1/T2 ratios in a pilot study as a potential biomarker of biopsy: proven benign and malignant breast lesions in correlation with histopathological disease stage.

Aim: Early breast cancer detection is important for intervention and prognosis. Advances in treatment and outcome require diagnostic tools with highly positive predictive value.

Purpose: To study the potential role of quantitative MRI (qMRI) using T1/T2 ratios to differentiate benign from malignant breast lesions.

[Myocardial Crypt of the Left Ventricle Combined With Barlows syndrome].

Myocardial crypts were initially described in patients with hypertrophic cardiomyopathy. Modern diagnostic data show that this structural abnormality can be found in patients with other diseases, or might represent the variant of normal heart development in healthy individuals. The prognostic significance of this finding is uncertain.

Optimization of protocol design: a path to efficient, lower cost clinical trial execution.

Managing clinical trials requires strategic planning and efficient execution. In order to achieve a timely delivery of important clinical trials' outcomes, it is useful to establish standardized trial management guidelines and develop robust scoring methodology for evaluation of study protocol complexity. This review will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and the right data are collected to demonstrate that a drug is safe and efficacious, while managing study costs and study complexity based on proposed comprehensive scoring model.