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NCT ID: NCT06252831 Completed - Dysbacteriosis Clinical Trials

Study of the Safety and Tolerability of the Broad-spectrum Probiotic Medicine "AS-Probionorm"

Start date: September 2, 2023
Phase: Phase 1
Study type: Interventional

The subject of this clinical trial is the medicine "AS-Probionorm". Pharmacological group - Antidiarrheal drugs. Antidiarrheal microorganisms. Microorganisms that produce lactic acid. The investigational probiotic medicine "AS-Probionorm" was created on the basis of an association of lactic acid bacteria with targeted action for oral use for the treatment of inflammatory and infectious diseases of the human gastrointestinal tract. The first phase of a clinical trial is the first test of a medicine conducted on healthy volunteers to establish tolerability and safety. According to the goal and objectives of the phase I clinical trial, the main parameter is to study the safety and tolerability of the medicine throughout the entire study period. Phase I of the clinical trial of the medicine included 20 healthy subjects of both sexes aged 18-50 years. Clinical and laboratory parameters to characterize the safety of the medicine: medical history, physical examination, ECG, general and biochemical blood tests, urine and stool tests. Selection and Exclusion of Subjects: Prior to inclusion in a clinical trial, each trial subject must first sign an Informed Consent Form for Participation in the Study, followed by a screening examination of each subject, including a variety of procedures, medical history, and physical examination. Each subject participating in the survey will be assigned an identification number. Study design: open-label, single-center, phase I of clinical trial. Dosage regimen - 1 sachet (1 g) 2 times a day with an interval of 12 hours. The total duration of study subjects' participation in the study is 21 days. Tolerability of the study drug: Tolerability of the drug will be assessed based on subjective symptoms and sensations reported by patients and objective data obtained by the investigator during the study. The frequency of occurrence and nature of adverse reactions are also taken into account. The degree of tolerability of the study drug will be determined in three gradations: intolerance, absence of undesirable drug reactions (side reactions), undesirable drug reactions (side effects) not classified as serious. Ethical and Legal Issues in Clinical Research: This clinical trial will be conducted in accordance with the principles set forth by the 18th World Medical Assembly (Helsinki, 1964) and the ICH guidelines for good clinical practice (GCP), and in accordance with all international and national laws and regulations.

NCT ID: NCT06209229 Completed - Clinical trials for Nonsmall-cell Lung Cancer

Role of Neutrophils and Electro-bioluminescence in the Rehabilitation

RNE
Start date: May 1, 2022
Phase: Phase 1
Study type: Interventional

The clinical study is to find out the effect of a course of immunomodulatory drugs and detoxification scheme on finger bioelectroluminescence and neutrophil function and their correlation with changes in quality of life and life expectancy in patients with malignant diseases against the background of restorative treatment and rehabilitation. Questions: 1. does the quality of life of patients with lung cancer change with the use of a course of immunomodulatory drugs and detoxification scheme? 2. does phagocytosis function, liposomal activity, mitochondrial function of neutrophils change against the background of the course? 3. does bioluminescence of fingers of hands change against the background of the course of immunotherapy? Participants will take Calcitreol capsules, Magnesium B-6 capsules, products containing quercetin flavonoids, Naderin (sodium deoxeribonucleate) daily for 21 days. before the course, after the course and after one year they will answer the QLQ-LC13, WHOQOL BREF, L.H. Garkavi adaptation self-assessment questionnaire and give blood for laboratory analysis of neutrophil function assessment.

NCT ID: NCT06094998 Completed - Child Development Clinical Trials

Health Status of Children Born After Assisted Reproductive Technologies

Start date: October 18, 2023
Phase:
Study type: Observational

The goal of this observational study is to study the features of psychophysical development and the morbidity patterns of children born after assisted pregnancy, and to identify the connection with the health status of mothers, followed by the development of a prediction model and general principles of management of children born after ART. The main questions it aims to answer are: • the influence of premorbid background of mothers on children's physical development, disease occurrence and morbidity patterns of children born as after ART. - To identify the indicators of cellular and humoral immunity in children born after different oocyte fertilization methods in IVF programs (classical IVF or ICSI). - To study the long-term effects of ART on the endocrine status of children. It will be studied hemogram examination, immunity indicators (cellular components CD3, CD4, CD8, CD16, CD20, CD25, CD95, CD3 HLA DR+, CD# HLA-DR; humoral components - IgM, IgA, IgE, IgG) and laboratory investigations in endocrine system (TSH, free T3 and T4 levels, insulin, insulin-like growth factor-1 (IGF-1), somatotropic hormone (STH); glucose, potassium, sodium) in 120 children born after ART. Researchers will compare 132 children conceived spontaneously to see if ART can influent on the health status in future.

NCT ID: NCT05742789 Completed - Cardiac Disease Clinical Trials

Effect of Anesthetics on Troponin I and С-reactive Protein

Start date: November 30, 2021
Phase: Phase 1
Study type: Interventional

Abstract Troponin is one of the cardiac biomarkers and its high level correlates to high risk of cardiac myocytes damage. C-reactive protein (CRP) in cardiosurgery participates in the Systemic Inflammation Response Syndrome, and heart-lung apparatus is a powerful stimulator of the systemic inflammatory reaction. Objective: To assess effect of anesthetics on troponin I and СRP in mitral, tricuspid and aortic valve replacement/plastic in adult. Methods. Single-center prospective randomized controlled clinical study. A total of 95 patients were assigned randomly into three groups according to the type of anesthesia: the first group of 32 patients with propofol, the second group with sevoflurane - 32 patients, and the last - 31 patients were with isoflurane. Levels of the cardiac troponin I were calculated in ng/ml с using a portable fluorometric analyzer I-CHROMAII, manufacture of BoditechMedInc (South Korea). Normal range: <0.04 ng/ml. CRP concentration in plasma has been determined using a biochemical analyzer Biosystems BA-200 (Spanish company, Barcelona) according to the manufacturer's instructions. The normal level of CRP is less than 5 mg/l.

NCT ID: NCT05717894 Completed - Clinical trials for Fibrocystic Breast Disease

Possibilities of Phytomedicine in Monotherapy of Benign Breast Diseases

Start date: January 11, 2020
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the effectiveness of the use of the drug, containing Vitex agnus castus extract (VAC), in patients with fibrocystic breast disease . One hundred fifty women over 40 years old were randomized into patient (n=78) and control (n=72) groups. The groups were similar regarding age, nulliparity, menopause and abortion status, family history of breast cancer, alcohol consumption, and smoking. The patient group received two pills containing 200mg of VAC daily for six months, and all participants were evaluated by using a Visual Analogue Scale and ultrasound examination at baseline, 12th and 24th weeks.

NCT ID: NCT05696509 Completed - Clinical trials for Mitral Valve Insufficiency

Influence of Anesthetics on Clinical Outcome in Mitral and Aortic Valve Replacement in Adults

Start date: January 3, 2020
Phase: Phase 3
Study type: Interventional

Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period. Total intravenous anaesthesia and inhalation anaesthesia are the traditional methods of anaesthesia in cardiac surgery. However, there are few studies assessing the effectiveness of surgical aggression protection in cardiac surgery. Objectives: To study the effect of anesthetics on clinical outcome after mitral and aortic valve replacement in adults. Methods. The data of 75 patients operated in the Cardiosurgery Department of the Medical Center Hospital of the Presidential Administration of the Republic of Kazakhstan were included in the study. All patients underwent mitral, aortic valve replacement/plasty under cardiopulmonary bypass (CPB) conditions. All patients were divided into 3 groups according to the type of anaesthesia: the first (1) group patients anaesthetised with propofol (P), the second group with sevoflurane (S), and the last one is with isoflurane (I). To maintain anaesthesia in Group 1 propofol was used as anaesthetic in a dose of 6 mg/kg/h intravenously on perfusion. In Group 2 the anaesthetic used was sevoflurane in a dose of 1.7-1.9 MAC. Group 3 used isoflurane in the dose of 1.1-1.2 MAC as anaesthetic. Statistical analysis was done by the method of single factor analysis of variance and Kruskal Wallis criterion.

NCT ID: NCT05695287 Completed - Clinical trials for Coronary Artery Disease

The Effects of Sevoflurane, Isoflurane and Propofol During Cardiac Surgery

Start date: January 22, 2021
Phase: Phase 1
Study type: Interventional

Abstract Anaesthetic support for cardiac surgery significantly influences the course of the intraoperative period and the success of the postoperative period. Total intravenous anaesthesia and inhalation anaesthesia are the traditional methods of anaesthesia in cardiac surgery. However, there are few studies assessing the effectiveness of surgical aggression protection in cardiac surgery. Objectives: To study the effectiveness of body protection against surgical aggression by TIVA and inhalational anaesthesia in cardiac surgery. Materials and methods. The examination and treatment data of 89 patients were included in the study. All patients underwent coronary artery bypass grafting, mitral valve replacement/plasty, aortic valve replacement cardiopulmonary bypass conditions. The patients were divided into 2 groups according to the type of disease: the first (1) group with coronary heart disease. The second (2) group with valvular heart disease. There were 65 patients in the first group and 22 in the second. Both groups were divided into 3 subgroups according to the type of anaesthesia: patients anaesthetised with propofol, with sevoflurane, with isoflurane.

NCT ID: NCT05693428 Completed - Clinical trials for CHD - Coronary Heart Disease

Influence of Anesthetics on Clinical Outcome During Cardiac Surgery in Adults

Start date: January 22, 2022
Phase: N/A
Study type: Interventional

Abstract Cardiac surgery in adults is associated with the occurrence of post-operative complications. Even minor complications can increase the cost of their treatment. Given the potentially preventable nature of a number of these postoperative complications, preventive methods should be used to improve outcomes after cardiac surgery. One of them, is the choice of anaesthetic technique. Objectives: To evaluate the effects of sevoflurane, isoflurane and propofol on blood oxygen transport function and body energy expenditure during cardiac surgery in adults. Materials and methods. A total of 90 patients were included in the study. All patients were divided into 3 groups: 1- (n=30) included patients who were anesthetized with propofol. The second group (n=30) consisted of patients who underwent sevoflurane inhalation anaesthesia. Group 3 (n=30) was treated with isoflurane. All patients underwent coronary artery bypass grafting under cardiopulmonary bypass.

NCT ID: NCT05654974 Completed - Observational Study Clinical Trials

Sexual Habits Affect Penis Size in Adulthood

ShiP
Start date: December 1, 2019
Phase:
Study type: Observational

Purpose: to assess in Kazakh adult males erect penis sizes, and study an influence of their natural physiological events and behavioral habits during their growing ages on their penile sizes nowadays. Study Design: An observational cross-sectional survey pilot study using a correlational design with the intention-to-treat principle.

NCT ID: NCT05635539 Completed - Clinical Trial Clinical Trials

Weight Loss in Patients With COVID-19 and Influenza in Comorbidity With NCDs: a Pilot Prospective Clinical Trial

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The goal of this study was to evaluate the effects of the fast weight loss on clinic and laboratory inflammation profile, metabolic profile, reactive oxygen species (ROS) and body composition in patients with COVID and Influenza in comorbidity with NCDs. Primary endpoints: Clinic/infectious/inflammation tests for COVID and Influenza; weight loss during 14 days. Secondary endpoints: fasting blood glucose, HbA1c, blood insulin; systolic/diastolic BP; blood lipids; ALT, AST, chest CT-scan.