Astrakhan

Researchers are evaluating transcutaneous electrical stimulation of the auricular vagus nerve (TENS) as a non-invasive method to influence the autonomic nervous system in patients with various health conditions. This technique targets the auricular branch of the vagus nerve using low-frequency electrical impulses applied to the ear, which is a promising, low-cost alternative to invasive vagus nerve stimulation treatments. The study aims to identify a reliable biomarker of successful vagus nerve activation through TENS, focusing on heart rate variability (HRV) measures, specifically the ratio of spectral characteristics known as LF/HF. The study involves TENS applied for 10 minutes, during which HRV parameters will be measured. These measurements will be taken initially at rest before stimulation, during the first and second 5-minute intervals of stimulation, and again after the stimulation ends. This method seeks to clarify the ambiguous effects of TENS on HRV observed in past research, which have shown inconsistent changes in the parasympathetic component of HRV. Participants will undergo monitoring of their heart rate variability dynamics throughout the study session. Researchers will assess changes in the LF/HF ratio as the primary outcome, evaluating these values before, during, and after TENS. The study excludes individuals with certain heart rhythm abnormalities, recent glucocorticosteroid use, use of antiarrhythmic medications (except beta blockers), or severe chronic kidney or liver disease to ensure participant safety and reliable data collection. The overall goal is to advance understanding of TENS as a neuro-immunomodulatory intervention by adhering to international consensus reporting guidelines.

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.

Researchers are conducting a large, non-interventional observational study to better understand adults with uncontrolled asthma across Russia. This study aims to gather detailed information on the demographic and clinical characteristics of these patients, the treatments they receive, and how their condition is managed in routine clinical practice. The study focuses on patients not treated with biologics and covers a diverse population from about 50 regions in Russia, reflecting differences in ethnicity, climate, and economic status. The study will include 9,000 adult patients with uncontrolled mild to moderate asthma who are receiving standard care. Data will be collected during 2-3 visits that follow routine clinical practice schedules. At the first visit, information from the previous 52 weeks will be gathered from medical records and patient interviews. The second visit will take place about 12 weeks later to collect follow-up data on treatment changes and clinical outcomes. For a subgroup of 500 patients using a fixed-dose combination of budesonide/salbutamol at the second visit, an additional third visit will occur 12 weeks later to further monitor treatment and outcomes. Participants will be monitored through medical record reviews and interviews during these visits. Researchers will assess baseline characteristics such as blood eosinophil counts, sputum eosinophils, and total IgE levels, along with treatment profiles and clinical outcomes. The study does not involve any experimental interventions beyond standard care and aims to provide comprehensive real-world data on uncontrolled asthma management in Russia. The total study duration for participants includes up to 24 weeks of follow-up for some patients.

Researchers are evaluating the effectiveness and safety of two treatments for chronic anal fissure, a painful condition involving a long-lasting tear in the anal canal mucosa resistant to non-surgical care. This condition mainly affects younger and working-age adults and is caused by spasms of the internal anal sphincter. The study compares botulinum toxin injections with lateral subcutaneous sphincterotomy, a surgical method, to determine the best approach for reducing symptoms and complications. The study involves two treatment groups. One group receives a sparing surgical removal of the fissure without cutting the internal sphincter, followed by injections of Botulinum Toxin Type A into specific points of the internal anal sphincter. The other group undergoes lateral subcutaneous sphincterotomy, where the internal sphincter muscle is partially cut to relieve spasm, performed under spinal anesthesia. Both treatments aim to alleviate sphincter spasm but differ in invasiveness and procedure details. Participants will be closely monitored for anal sphincter insufficiency up to 60 days after treatment, focusing on symptoms like incontinence. Assessments include clinical evaluations of sphincter function and safety monitoring for any adverse effects. The study aims to find a treatment that lowers the risk of post-operative incontinence while effectively treating chronic anal fissure, with total participation duration covering the treatment and follow-up period.

Researchers are collecting information about patients in Russia who have extremely high levels of triglycerides in their blood, defined as levels of 10 mmol/L or more. This condition, called extreme hypertriglyceridemia, is linked to higher risks of heart disease, acute pancreatitis, and death from any cause. The study aims to understand the characteristics of these patients, including clinical features, genetics, and how the condition is diagnosed and treated in everyday medical practice. This is an observational registry, meaning no experimental treatments or invasive procedures are given as part of the study. Patients continue their usual medical care while data are collected from their routine tests, medical records, and any genetic testing performed. The registry does not change medications or introduce new therapies but monitors patients' clinical status and documents laboratory results and treatment patterns. Participants are followed at least once a year or more often if needed, with no set end date for follow-up. There are no age limits for joining, and all participants or their legal guardians provide written consent before inclusion. The main outcome measured is mortality, including deaths from any cause and specifically from cardiovascular causes, tracked over an average of 20 years. Data privacy is maintained, and patients may withdraw at any time without affecting their care.

Researchers are studying the presence and types of other health conditions in patients having abdominal surgery to better understand and categorize the risk of complications after surgery. The goal is to identify which existing diseases independently predict such risks, as this knowledge is important for informed consent and planning preventive care. The study focuses on adults with certain physical health statuses undergoing planned operations, noting that while anesthesia risks have decreased, complications remain a significant concern worldwide. The study collects detailed information before surgery about patient age, gender, physical status (ASA classification), various chronic diseases like heart, lung, kidney, neurological disorders, and diabetes, as well as treatments the patient is receiving. It also records the type and severity of different abdominal surgeries and anesthesia methods used. Data is gathered uniformly from multiple centers and entered into an electronic database. The study includes patients operated on within defined days and monitors them until hospital discharge. Participants will have their health and surgical data collected and tracked, including cognitive function, respiratory and cardiac risk scales, and kidney and liver function. Postoperative complications occurring within 7 days of surgery are the main outcomes measured. The study plans to enroll a large number of patients to develop reliable risk prediction models, with ongoing data analysis using statistical methods to identify significant predictors. Results will be validated with additional patient groups to improve accuracy and clinical usefulness.

Researchers are conducting an observational surveillance study to identify the genetic types of rickettsia bacteria causing rickettsioses in patients from various regions of Russia. The study focuses on patients with diagnosed or suspected tick-borne rickettsioses. It aims to link genetic information of the bacteria with patients' medical histories, disease progression, symptoms, and treatments to find clinical patterns specific to different causative agents. The study is non-interventional and has received ethical committee approval. No changes are made to patients' routine treatment or diagnostic procedures during the study. Biological samples such as blood, plasma, buffy coat, serum, or eschar swabs collected during standard diagnostics are used for genetic analysis of the rickettsia species. These residual diagnostic samples are collected only after patients or their legal representatives give written informed consent. Physicians complete individual case report forms to record relevant medical information for each participant. Participants provide informed consent, and their medical history, symptoms, disease course, and treatments are recorded. The genetic typing of rickettsia bacteria is performed within up to 4 weeks after sample collection. The study monitors these genetic findings alongside clinical data to improve understanding of rickettsioses. There is no intervention or alteration in patient care, and the study respects current medical standards throughout its observation period.