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NCT ID: NCT05757557 Active, not recruiting - Clinical trials for Chronic Kidney Disease

Perioperative Nitric Oxide Prevents Acute Kidney Injury in Cardiac Surgery Patients With Chronic Kidney Disease

DEFENDER
Start date: February 25, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The protective nitric oxide (NO) effects are mediated by selective pulmonary vasodilation and improvement of arterial oxygenation in hypoxemic patients by reducing intrapulmonary shunting and improving ventilation-perfusion coordination. Inhaled NO has been used for years to treat acute respiratory failure and pulmonary hypertension in anesthesia and intensive care. The nephroprotective role of NO was studied in an experimental model of contrast-induced nephropathy. The primary aim of this prospective, double-blind, randomized, parallel-group, controlled trial is to test the hypothesis that perioperative conditioning of patients with NO at a dose of 80 ppm, obtained by plasma-chemical synthesis technology, through a ventilator and an extracorporeal circulation circuit reduces the incidence of acute kidney injury (AKI) in patients with an initially high risk of kidney damage due to the presence of preoperative chronic kidney disease (CKD). The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk NRMC for elective surgery with high risk of AKI in the perioperative period

NCT ID: NCT05745909 Active, not recruiting - Neoplasms Clinical Trials

Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

LIVELOC
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.

NCT ID: NCT05740436 Active, not recruiting - Clinical trials for Frail Elderly Syndrome

Protocol of Geriatric Rehabilitation in Patients of 60 and Older Who Live in Moscow Boarding Houses or Nursing Homes

POSTSCRIPTUM
Start date: August 21, 2021
Phase:
Study type: Observational

After screening complex geriatric assessment (CGA) the participants will undergo geriatric rehabilitation programs. After termination of 21-day program, CGA will be repeated and subjects will get a program of long-term rehabilitation. A phone call in six months and a face-to-face visit in 12 months will be scheduled to follow-up and to evaluate the progress in rehabilitation.

NCT ID: NCT05739006 Active, not recruiting - Melanoma Clinical Trials

Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies

Start date: February 8, 2021
Phase: Phase 1
Study type: Interventional

Clinical study BCD-201-1 is a double-blind randomized study of the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of BCD-201 versus Keytruda following intravenous administration to subjects with advanced unresectable, metastatic, or recurrent melanoma and NSCLC. The study aimed to establish the equivalence of PK and similarity of the safety, immunogenicity, and PD profiles of BCD-201 and Keytruda.

NCT ID: NCT05738993 Active, not recruiting - Breast Cancer Clinical Trials

A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers

Start date: August 8, 2022
Phase: Phase 1
Study type: Interventional

This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male volunteers

NCT ID: NCT05737329 Active, not recruiting - Clinical trials for Primary Ovarian Insufficiency

Efficacy, Safety, and Tolerability of Higher Doses Estrogen Therapy in Women With Premature Ovarian Insufficiency

Start date: March 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this study is to assess the effects of higher doses versus standard hormone therapy on quality of life (QoL), symptoms due to estrogen deficiency, and bone health in women with premature ovarian insufficiency (POI). The efficacy of the hormonal treatment will be assessed clinically and also by measuring serum concentrations of Estradiol (E2), Follicle-Stimulating Hormone (FSH), Luteinizing hormone (LH), total Testosterone (T), Estrone (E1), E1 sulfate (E1S), and Sex Hormone Binding Globulin (SHBG). Bone mineral density (BMD) will be measured using dual-energy X-ray absorptiometry. Safety will be assessed by measuring endometrial thickness with Gynecological transvaginal ultrasound (TVS), treatment-related adverse events (AEs) and treatment-emergent AEs monitoring.

NCT ID: NCT05736159 Active, not recruiting - School Readiness Clinical Trials

Scientific Justification of Assessment Criteria and Improvement of the Methodology for Assessing School Maturity

Start date: May 1, 2023
Phase:
Study type: Observational

One of the critical stages in a child's life is the beginning of school, accompanied by intense intellectual and psycho-emotional stress. The success of educational activities depends on the child's readiness to enter school - his school maturity. The two main components of school maturity are the level of formation of school skills and the physical development of the child in the preschool period. Recent studies show that adaptation is more favorable in children with an average level of physical development (Zhdanova L.A., Rusova T.V., Shishova A.V., 2020), at the same time there is also a reverse effect - children with a delayed type of development are more susceptible to the development of maladaptation. This relationship opens up new opportunities in the development of methods for assessing school maturity, as well as preventive measures for the timely prevention of maladaptation of children to school. The relevance of the topic of the peer-reviewed research work is determined by the need to develop and substantiate modern criteria for assessing school maturity. The purpose of the work is to study the hygienic aspects of children's adaptation to the beginning of school education in order to improve the methodology of comprehensive assessment of school maturity and the development of measures to prevent maladaptation. To solve it, five tasks have been formulated, the essence of which is to study the factors affecting the course of adaptation of the child, to scientifically substantiate the criteria for assessing school maturity and the development of preventive measures for the timely prevention of maladaptation. To solve the tasks set, a study of anthropometric indicators and indicators characterizing school maturity and the level of formation of school skills will be conducted among 1,000 children aged 3-8 years studying in preschool educational and general education organizations of the Samara region. The results of the study will be implemented in the work of preschool educational and general education organizations of the Samara region, and in the future, in the department of hygiene of children and adolescents of the Federal Budgetary Health Institution "Center for Hygiene and Epidemiology in the Samara region".

NCT ID: NCT05726084 Active, not recruiting - COVID-19 Clinical Trials

Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older

Start date: October 24, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trial is to assess the immunogenicity, efficacy and safety of the Convacell vaccine in healthy adult volunteers aged 18 years and older. The main questions it aims to answer are: - To assess the immunogenicity and safety of single and double dose intramuscular administration of the Convacell vaccine; - To assess the epidemiological effectiveness of the Convacell vaccine in the prevention of SARS-CoV-2 infection and development of severe COVID-19 compared with placebo when single or double intramuscular injection.

NCT ID: NCT05715983 Active, not recruiting - Pilonidal Disease Clinical Trials

Comparison of Laser Destruction of Pilonidal Sinus Disease (SILAC) and Bascom II Procedure.

SI-BAS
Start date: December 8, 2022
Phase: N/A
Study type: Interventional

Surgical treatment witn lateralization of intergluteal cleft is still gold standard for pilonidal sinus disaease. But nowadays minimally invasive treatment methods such as the use of a diode laser (SiLac, Sinus Laser Closure) to obliterate the coccygeal tract are used more often. The aim of the study is to compare a new minimal invasive method (laser treatment) with traditional method ( Bascom II) in terms of recurrence rate, complications and patients satisfaction with results.

NCT ID: NCT05715918 Active, not recruiting - Vaccine Clinical Trials

Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 of Children at the Age of 12-17 Years Inclusive"

Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R&D IBP RAS", of childrens aged 12-17" (Clinical trials, phase III). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine of chidrens aged 12-17