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NCT ID: NCT06419829 Active, not recruiting - Physical Activity Clinical Trials

Physical Activity, Posture and Body Composition in Ontogeny

Start date: January 15, 2023
Phase:
Study type: Observational

The main aim of the research is to assess the impact of various forms of physical activity on body composition and posture. The basis of the research is the assessment of the current condition of people of different ages and the development of individualized physioprophylaxis programs for body posture and body weight abnormalities. In the senior group, the task of physioprophylactic programs is to prevent the loss of muscle mass, prevent falls and improve the quality of life.

NCT ID: NCT06391216 Active, not recruiting - Healthy Clinical Trials

The Effect of Probiotic Supplementation on Mental Health in Healthy Volunteers

ProBeMent
Start date: May 6, 2024
Phase: N/A
Study type: Interventional

Probiotics are "live microorganisms which when administered in adequate amounts confer a health benefit on the host". Accumulating evidence indicates their effect in mental health restoration. Beneficial neuropsychological and psychobiological effects are particularly well substantiated in clinical samples. However, it is not clearly documented whether probiotic supplementation reduces depressive and anxiety symptoms in healthy volunteers experiencing temporal deterioration in mental functioning while facing a stressful event. The combination of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 is particularly well studied in terms of its central nervous system action with significantly deciphered mechanism. As a result, this combination is particularly promising to study the effect of mental health improvement in healthy volunteers facing a stressful event. The aim of this project is to assess the impact of a 8-week supplementation with probiotic combination of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 strains in the daily dose of 3 × 10^9 colony forming units on mental health measures and oral microbiota composition and metabolome in healthy young adults facing a psychologically stressful event. The aim will be achieved by comparing the probiotic combination supplement to placebo in a randomized triple-blind controlled trial settings with a participant allocation ratio of 1:1. The summer academic examination session and the upcoming first take of the final exam in pharmacology at third year of medical studies will be a model of a stressful event. The participants will supplement their diets with probiotic/placebo for 8 weeks before the exam. After giving written informed consent, before the supplementation (relatively stress-free time period in terms of academic activities) the participants will provide background sociodemographic, anthropometric and psychometric data. At that time, participants will also give samples of saliva to assess cortisol and selected cytokines concentrations as well as salivary microbiome and metabolome. At the end of supplementation, a day before the final exam, participants will donate salivary samples and do psychometric tests for the second time to assess the same parameters as at the beginning of the study. Participants will also do a pre-exam test in pharmacology (not considered a formal academic assessment) as a comparator for the results of the formal examination held a day after.

NCT ID: NCT06375668 Active, not recruiting - Clinical trials for Osteoporosis, Postmenopausal

The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months.

NCT ID: NCT06370858 Active, not recruiting - Crohn Disease Clinical Trials

RVT-3101 for the Treatment of Moderate to Severe Active Crohn's Disease

Start date: July 24, 2023
Phase: Phase 2
Study type: Interventional

This Phase 2, randomized, double-blind, multicenter, induction and maintenance study is designed to evaluate the safety and efficacy of RVT-3101 in adult participants with moderate to severe active Crohn's disease.

NCT ID: NCT06325228 Active, not recruiting - Healthy Clinical Trials

Musculoskeletal Injuries, Sports Performance, Sports Specialization, and Quality of Life in Young Athletes

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

The primary aim of this observational cohort study is to assess sports specialization, sports performance, history of injuries (prevalence, types, areas, duration) and quality of life in young healthy athletes aged 8-16 from Poland. Athlete profiles will be created based on the variables (explained in detailed description) examined. Furthermore, the investigators will perform one-year injury follow-up. The main questions it aims to answer are: - Do athletes with a specific profile (lower values in athletic performance tests, low values in quality of life) evaluated at one time point, suffer injury in the future in annual observation? - Do athletes with high sports specialization will sustain injury in one-year follow-up? - Does sports specialization have a relationship with sports performance tests, and quality of life? - Does sport specialisation, training volume, geographical factor relate to injury history? - Does sports specialisation, injury history differ between sports (individual and team sports)? - Does value of the specific muscle (lower limb) isometric strength will be associated with the dynamic balance scores in young healthy athletes?

NCT ID: NCT06286488 Active, not recruiting - Obesity Clinical Trials

Effectiveness and Tolerability of Influenza Vaccine in Patients at Risk for Severe and Complicated Influenza

Start date: September 15, 2020
Phase: Phase 4
Study type: Interventional

The aim of the study is to evaluate simultaneously the immunological and clinical efficacy and tolerability of an influenza vaccine, inactivated, quadrivalent, with cleaved virus, in patients at risk for severe and complicated influenza routinely vaccinated against influenza in family medicine clinics or specialty clinics (pediatric, internal medicine, cardiology, gynecological diabetes, pregnant women, transplant).

NCT ID: NCT06235424 Active, not recruiting - Clinical trials for Aortic Valve Disease

Del Nido Versus HTK Cardioplegia in Adult Aortic Valve Replacement

Start date: October 1, 2018
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare del Nido and Bretschneider-HTK (HTK) cardioplegia solutions in patients undergoing elective aortic valve replacement. The main question it aims to answer is: • Does the del Nido cardioplegia provide better cardioprotection and clinical outcomes than HTK cardioplegia? Participants will receive one of the investigated cardioplegia solutions according to the randomization. Researchers will compare both groups in terms of cardioprotection (described as levels of CK-MB and hsTnI), in-hospital clinical outcomes, biochemical changes in coronary sinus blood and one-year follow-up.

NCT ID: NCT06223087 Active, not recruiting - Cold Exposure Clinical Trials

Effects of Winter Swimming on Blood Indicators and Oxidative Stress in Males

Start date: January 1, 2021
Phase:
Study type: Observational

Exposure of the human body to cold water triggers numerous beneficial physiological changes. The study aimed to assess the impact of regular winter swimming on blood morphological, rheological, and biochemical indicators and activity of antioxidant enzymes in males. The study includes winter swimmers and a control group. Blood samples were taken twice - before the start (November) of the winter swimming season and after its end (March). The average duration of ice water baths was 3-5 minutes, with a minimum frequency of once a week. The water temperature during the swimming did not exceed 10°C, approaching 0°C during the winter period.

NCT ID: NCT06190600 Active, not recruiting - Breast Cancer Clinical Trials

Supervised Physical Activity in Young Women With Early Breast Cancer During Neoadjuvant Chemotherpy

SPORTNATHy
Start date: October 11, 2018
Phase: N/A
Study type: Interventional

The main goal of this study is to assess the impact of supervised intense physical activity (IPA) on outcomes of neoadjuvant chemotherapy in young women with breast cancer (YWBC). In this project standard neoadjuvant chemotherapy will be used concordant with summary of product characteristics (SPC). However during treatment (including days of chemotherapy application) an additional modifier of therapy will be carried out in the form of intense physical activity. This strategy is not recognized in SPC. This project aims to improve the results of breast cancer treatment in young women. According to available data, nowadays this subset of breast cancer patients has worse therapy results in comparison to older women. This is partially because of the different tumor characteristics; young women are more likely to present with human epithelial growth factor receptor 2 (HER2) receptor overexpression or with triple negative breast cancer. In the treatment of YWBC, preoperative chemotherapy is most often the first step. This enables the opportunity to assess the effectiveness of additional interventions in a mode it was never tested before. It is believed that physical activity improves the results of breast cancer treatment, however there are only few reports describing its benefit and role in terms of preoperative chemotherapy. In the current project, the investigators planned to introduce supervised increased physical activity concurrently with neoadjuvant treatment in YWBC at early stage of disease. The main goal of the study is to assess the effect of physical activity on preoperative chemotherapy outcomes. The change of tumor size after neoadjuvant chemotherapy, as well as the impact on Quality of Life (QoL) and Patients' Reported Outcome (PRO) in described above treatment modality. Secondary endpoints are the following: the pathologic Complete Response (pCR), disease free survival after 3 years (3-yr DFS), overall survival (OS), cardiotoxicity of treatment, the effect of physical activity on tumor microenvironment and Ki67 as well as the impact of increased physical activity on further patients' lifestyle changes.

NCT ID: NCT06134804 Active, not recruiting - Clinical trials for Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention

A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older

Engage
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to show that high-dose quadrivalent seasonal influenza vaccine (HD QIV) given together with 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) does not induce lower antibody response against each of the 4 influenza vaccine strains, as compared to HD QIV given alone and further show that ExPEC9V given together with HD QIV does not induce lower antibody response against each of the vaccine O-serotype antigens, as compared to ExPEC9V given alone.