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NCT ID: NCT06342778 Completed - Nausea Clinical Trials

Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin

Start date: February 27, 2024
Phase: Phase 1
Study type: Interventional

Comparative study of pharmacokinetics and bioequivalence of the study drug Doxylamine + Pyridoxine, enteric-soluble, film-coated tablets, 10 mg + 10 mg (Valenta Pharm JSC, Russia), and reference drug Diclectin, delayed-release tablets, 10 mg + 10 mg (registration certificate holder - Tzamal Bio-Pharma, Israel, manufacturer - Duchesnay Inc, Canada) in healthy volunteers after meals

NCT ID: NCT06338943 Recruiting - Clinical trials for Pregnancy Complications

Middle-aged Women With Adverse Pregnancy Outcomes and Heart Failure With Preserved Ejection Fraction

MAPO-HF
Start date: March 18, 2024
Phase:
Study type: Observational

Due to the steady increase in the burden of HFpEF, especially in women, it is an important task to search for new markers and early predictors associated with the development of this disease. Nowadays, the relationship of adverse pregnancy factors with the development of long-term cardiac pathology, in particular, HFpEF, has not been completely established. One of the most significant issue is studying the younger phenotype of women. The goal of this observational analytical cross-sectional study is to study the relationship of heart failure with a preserved ejection fraction in middle-aged women with adverse pregnancy outcomes in the history of pregnancy. Research question: is there an association between adverse pregnancy factors and the development of HF in middle-aged women? Objectives 1. To assess the frequency of detection of APOs in the history of pregnancy in middle-aged women, depending on the presence or absence of HFpEF. 2. To compare clinical and anamnestic data, morphological and functional parameters of the heart in middle-aged women with the presence and absence of HFpEF. 3. To establish an association between APOs and the development of HFpEF in the long-term period in middle-aged women. 4. To identify mediators between the presence of APOs and the development of HFpEF in middle-aged women. Study population - 45-60 year-old women with the history of pregnancy (>20 weeks) in the absence of low left ventricle ejection fraction (<50%) Primary endpoint: The prevalence of HFpEF in patients with the history of APOs.

NCT ID: NCT06338839 Recruiting - Clinical trials for Transthyretin Amyloidosis Cardiomyopathy, Heart Failure With Preserved Ejection Fraction

Transthyretin Amyloidosis Cardiomyopathy in Patients With HFpEF in Russia

TETRAMER
Start date: December 28, 2023
Phase:
Study type: Observational

A multicenter observational retrospective-prospective study of prevalence and clinical characteristics of transthyretin amyloidosis (ATTR) cardiomyopathy (CM) in Russian patients with heart failure with preserved ejection fraction (HFpEF) in real clinical practice. The retrospective phase will entail secondary data collection from electronic or paper medical records of patients who are participating/participated in the PRIORITY-CHF study and have HFpEF. Those patients who have a high suspicion of having ATTR-CM and provided informed consent will be invited to participate in the prospective phase. The prospective phase will consist of three visits, during which a routine comprehensive cardiologic evaluation in order to confirm or exclude ATTR-CM diagnosis will be performed. In patients with confirmed ATTR-CM the material for genetic testing will be collected in order to specify the type of ATTR-amyloidosis

NCT ID: NCT06336213 Recruiting - Clinical trials for Thoracic Aortic Aneurysm

Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

Start date: February 19, 2024
Phase: N/A
Study type: Interventional

According to the literature, presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units, but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery. Previous study carried out in Petrovsky NRCS related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis.

NCT ID: NCT06333210 Active, not recruiting - Clinical trials for Axial Spondyloarthritis

Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)

Start date: December 25, 2023
Phase: Phase 3
Study type: Interventional

The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis (axSpA). The study will include HLA-B27+ patients with radiographic (r-axSpA) and non-radiographic (nr-axSpA) who had no response to prior therapy with non-steroidal anti-rheumatic drugs (NSAIDs), have not received biologic disease-modifying anti-rheumatic drugs (bDMARDs) or targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), and subjects with insufficient efficacy and/or loss of efficacy on bDMARDs and/or tsDMARDs.

NCT ID: NCT06332833 Recruiting - Clinical trials for Peripheral Arterial Disease

Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery

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

Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed.

NCT ID: NCT06332768 Completed - Clinical trials for Acute Respiratory Distress Syndrome

NIV Versus HFO Versus Standard Therapy Immediately After Weaning From Mechanical Ventilation in ARDS Patients

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

The weaning failure is a paramount challenge when aggressive discontinuation of respiratory support in ARDS. The aim of the study is to improve weaning safety and efficacy by a transient postextubation non-invasive respiratory support.

NCT ID: NCT06331741 Recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

Collagen for Treatment of Musculoskeletal Injuries

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The purpose of the study: Evaluation of the clinical efficacy and safety of the use of collagen matrix/membrane in the surgical treatment of the consequences of injuries and diseases of the musculoskeletal system (anterior cruciate ligament tears, rigid first toe) by using IKDC, KOOS, ACLOAS, VAS, AOFAS, SF-36 scales

NCT ID: NCT06328348 Completed - Menopause Symptoms Clinical Trials

Assessing the Synergistic Effects of Black Cohosh, Soy Isoflavones, and SDG Lignans (Soloways TM) on Menopausal Symptoms

Start date: July 18, 2023
Phase: N/A
Study type: Interventional

This clinical trial aimed to evaluate the effectiveness of a combination of Black Cohosh, Soy Isoflavones, and SDG Lignans compared to a placebo in reducing menopausal symptoms in postmenopausal women aged 45-60 years. The study was meticulously designed to be a randomized, double-blind, parallel-group trial, ensuring rigorous scientific standards and participant confidentiality. It received ethical approval and adhered to the Declaration of Helsinki guidelines. Participants were carefully selected based on specific inclusion and exclusion criteria to maintain the study's integrity and relevance to the target population. The trial involved 96 eligible women from the Center for New Medical Technologies registry in Novosibirsk, Russia, divided into two groups through a computer-generated random sequence. One group received the active supplements, while the other received a placebo, with both groups and researchers blinded to the assignments. The supplements and placebos were produced to be indistinguishable in appearance, with dosages designed to maximize absorption and efficacy while minimizing side effects. The primary endpoint was the change in Menopause Rating Scale (MRS) scores, with secondary outcomes focusing on adverse symptoms and key hormonal changes. The study's design also included measures to ensure adherence and minimize bias, such as drug container returns and daily reminders. The involvement of S.Lab (Soloways) was limited to manufacturing the supplements, with the research conducted independently to avoid commercial influence. The sample size calculation indicated that 48 participants per group would provide adequate power to detect significant differences in menopausal symptom reduction, aiming for a high level of confidence and statistical power.

NCT ID: NCT06321341 Recruiting - Vertigo Clinical Trials

Efficacy and Safety of Vespireit, Sustained-release Tablets, in Patients With Autonomic Dysfunction Syndrome Accompanied by Functional Vertigo

Start date: January 24, 2024
Phase: Phase 4
Study type: Interventional

Study of efficacy and safety of Vespireit, prolonged-release tablets, 15 mg (Valenta Pharm JSC, Russia) in comparison with Arlevert, tablets, 40 mg + 20 mg (Menarini International Operations Luxembourg S.A., Luxembourg) in patients with autonomic dysfunction syndrome accompanied by functional vertigo.