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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: NCT06313164 Completed - Type 2 Diabetes Clinical Trials

The Impact of Oral Glutathione on Oxidative Damage and Glycated Hemoglobin (HbA1c) Levels in Type 2 Diabetes Patients

Start date: June 20, 2023
Phase: N/A
Study type: Interventional

This trial aims to assess the effectiveness of L-glutathione, supplemented with bioavailability boosters (tannin, low molecular weight chitosan, and polyethylene glycol), on improving antioxidant levels and glycemic control in patients with type 2 diabetes (T2D). The study is designed as a randomized, double-blind, placebo-controlled trial intending to enroll 240 T2D patients. The primary objective is to measure changes from baseline to 180 days in several key biomarkers, including endogenous reduced glutathione (GSH), oxidized glutathione (GSSG), 8-hydroxydeoxyguanosine (8-OHdG), and glycated hemoglobin (HbA1c), along with other metabolic parameters. Hypothesis: The anticipated outcome is a significant increase in GSH levels and a decrease in markers of oxidative damage among participants receiving L-glutathione compared to those in the placebo group, potentially indicating improved antioxidant defenses and some effects on glycemic regulation in T2D patients. This trial aims to fill gaps in current research regarding the role of L-glutathione supplementation in managing oxidative stress and metabolic control in diabetes.

NCT ID: NCT06302179 Completed - Colorectal Cancer Clinical Trials

Risk Factors of Venous Thromboembolism After Colorectal Cancer Surgery

Start date: January 2015
Phase:
Study type: Observational

Aim of our study is to find frequency and identify risk factors for venous thromboembolism development in patients who underwent surgery for colorectal cancer. There were 137 patients enrolled in our retrospective observational cohort study. Included patients were operated for incisional hernia in Saveljev University Surgery Clinic from January 2016 to December 2017. Compression duplex ultrasound of lower legs veins was performed in 2-14 days after surgery for all participants. The primary endpoint was the occurrence of the venous thromboembolism event, including pulmonary embolism.

NCT ID: NCT06281587 Completed - Graft Rejection Clinical Trials

Pathogenetic Risk Factors for Corneal Graft Rejection

Start date: January 2011
Phase:
Study type: Observational

There are many predictors that may influence the development of corneal graft rejection after penetrating keratoplasty. In our study investigators analysed the results of keratoplasty and the risk factors for graft rejection. Investigators analysed data from 493 patients who underwent penetrating keratoplasty between 2011 and 2019. Keratoplasty outcomes were followed up at subsequent clinic visits until December 2021. Then, 93 medical records were selected (taking into account the completeness of the medical records) and divided into two groups based on the primary diagnosis that was an indication for keratoplasty: high-risk and low-risk patients. Investigators then estimated the survival time (clear graft) of the corneal graft using Kaplan-Meier statistical survival analysis. Investigators also investigated the factors that influence corneal graft opacity.

NCT ID: NCT06267287 Completed - Joint Infection Clinical Trials

Microbiological Structure of Pathogens of Periprosthetic Infection of Large Joints in the Post-Covid Period

Start date: January 1, 2018
Phase:
Study type: Observational

Background. Infection is the most common complication of complications after joint arthroplasty. During the COVID-19 pandemic increased used antibacterial drugs by adults, this could change the spectrum of infectious agents and their antimicrobial resistance. The purpose of the study is to evaluate the microbial diversity of pathogens of periprosthetic infection in the pre- and post-Covid period, determining the sensitivity of the leading pathogens to antibiotics. Materials and methods. A comprehensive comparative retrospective study was carried out on 342 cases of monomicrobial and polymicrobial periprosthetic infection (PPI) of limb joints with microbiological growth of microorganisms in the pre-Covid (2018-2019) and post-Covid (2021-2022) periods.

NCT ID: NCT06221826 Completed - Clinical trials for Ischemic Stroke, Acute

MEXIDOL® in the Rehabilitation Treatment of Patients With Acute Cerebral Failure

Start date: April 17, 2023
Phase: Phase 4
Study type: Interventional

The use of metabolic modulators creates prospects for increasing the efficiency of the rehabilitation treatment of patients with acute cerebral failure

NCT ID: NCT06221696 Completed - Clinical trials for Overweight and Obesity

Preventing Weight Regain Post-Semaglutide Treatment With Active Fiber Supplement (Soloways)

PWR-FAST
Start date: June 12, 2023
Phase: N/A
Study type: Interventional

This randomized, double-blind, placebo-controlled trial titled "Preventing Weight Regain Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)" evaluated the efficacy of an active fiber supplement in preventing weight regain post-Semaglutide treatment. Participants were adults aged 18-65, with a history of obesity or overweight, and had completed a Semaglutide course. The study involved 160 participants, equally divided into two groups: one receiving the active fiber supplement (glucomannan, inulin, and psyllium) and the other a placebo, both taken 30 minutes before each main meal for 180 days. Co-primary endpoints were the percentage of weight regain from baseline to day 180 and metabolic health markers (blood glucose levels, HbA1c, lipid profile, blood pressure). Secondary endpoints included changes in BMI, body composition, and appetite assessment using VAS ratings and the Control of Eating Questionnaire (CoEQ). Participants also adhered to a reduced-calorie diet and increased physical activity, with all standard assays performed in a central laboratory. The study's objective was to determine the supplement's effectiveness in enhancing satiety, improving digestive health, and thus better managing weight compared to a placebo

NCT ID: NCT06215196 Completed - Clinical trials for Overweight and Obesity

Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity

ESSENCE
Start date: April 14, 2023
Phase: N/A
Study type: Interventional

This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.

NCT ID: NCT06189716 Completed - Healthy Volunteers Clinical Trials

Gas Composition in the Oropharynx During High-flow Oxygen Therapy Through Nasal Cannula in Healthy Volunteers

Start date: January 9, 2024
Phase: N/A
Study type: Interventional

Observational, randomized studies and their meta-analyses have shown the high effectiveness of high-flow oxygen therapy through nasal cannulas, reaching 50-60% in acute hypoxemic respiratory failure. Some bench studies showed the advantages of high-flow oxygen therapy compared with standard oxygen therapy, consisting in reducing the anatomical dead space and maintaining a given inspiratory oxygen fraction in the hypopharynx of the mannequin, but the actual state of the gas composition of the hypopharynx was not studied. The study aim is measurement of the inspiratory (FiO2) and expiratory (FeO2) fractions of oxygen, as well as the inspiratory (FiСO2) and expiratory (FeСO2) fractions of carbon dioxide in the hypopharynx of healthy volunteers during high-flow oxygen therapy through nasal cannulas in different physiological conditions.

NCT ID: NCT06188832 Completed - Obesity Clinical Trials

Efficacy of Dietary Fiber Supplementation (Soloways) in Patients With Specific Genetic Polymorphisms

SOLFIBERGP
Start date: March 2, 2022
Phase: N/A
Study type: Interventional

This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.