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Found 3 Actively Recruiting clinical trials

E

Actively Recruiting

Researchers are evaluating 7-Ketolithocholic Acid, a naturally occurring bile acid, to assess its potential metabolic benefits, particularly its ability to lower glucose levels in adults with prediabetes. The study aims to determine whether this treatment, combined with a low-glycaemic, calorie-restricted diet and increased physical activity, can reduce fasting plasma glucose and other metabolic markers. This research focuses on early intervention to potentially prevent or delay the onset of type 2 diabetes. Participants will be randomly assigned to one of two groups one receiving 400 mg of 7-Ketolithocholic Acid daily in coated tablet form, and the other receiving matching placebo tablets without the active ingredient. Both groups will follow a low-glycaemic, hypocaloric diet and recommended physical activity including aerobic exercise, resistance training, and flexibility activities. The study includes six visits over approximately 16 weeks, covering screening, enrollment, periodic monitoring, and end-of-treatment assessments. Throughout the study, participants will undergo laboratory tests including fasting plasma glucose, HbA1c, cholesterol levels, and oral glucose tolerance tests. Diaries for diet and physical activity will be maintained and verified at scheduled visits and phone calls. Researchers will monitor adverse events and medication use at each visit. The primary outcome is the change in fasting plasma glucose from baseline to week 12, with additional metabolic and body measurements assessed as secondary outcomes. The study duration per participant spans about four months from screening to end of study.

Age: 18Years - 70YearsAll GendersPhase Not Applicable
8 locations
I

Actively Recruiting

Older adults face a high risk of acute respiratory infections, which lead to hospitalization, death, and loss of independence globally. Reduced immune function with age and environmental exposures increase vulnerability and lower vaccine effectiveness. This international study evaluates the impact of hospitalizations caused by respiratory viruses such as influenza, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus on loss of autonomy in people aged 60 and older to guide better prevention and vaccination approaches. The study observes individuals hospitalized with confirmed infections from these respiratory viruses. There are no experimental treatments instead, researchers monitor the patients over time to assess changes in their ability to perform daily activities. Functional dependency is measured at hospital admission, discharge, and at 3 and 6 months after discharge. The study also tracks health outcomes like medical complications, length of hospital stay, ICU admission, readmissions, new medications, and living situation changes. Participants will undergo evaluations of their daily living skills using standardized scores at multiple time points during and after hospitalization. Data on demographics, vaccination status, and comorbidities are collected at baseline. Follow-up phone assessments at 3 and 6 months help capture recovery and long-term effects. The study aims to deepen understanding of how respiratory infections affect older adults independence and support strategies for healthier aging.

Age: 60Years +All Genders
24 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the clinical performance and long-term safety of scaffold implantation for patients with coronary artery disease in a real-world regional setting. This observational prospective study involves two networks of centers, including all cath-labs in Emilia-Romagna and centers from the MAGIC retrospective study. Investigators have agreed on specific indications and implantation strategies to ensure consistency across centers. The treatment being studied is the implantation of at least one scaffold device during percutaneous coronary intervention PCI. The study focuses on complete revascularization in patients under 65 years, long lesion revascularization especially in the left anterior descending artery, and spontaneous coronary dissection. Implantation strategies include mandatory predilation, precise sizing, avoiding vessels outside specific diameter ranges, and mandatory postdilation with a non-compliant balloon. Participants will be enrolled after approval and followed for safety and outcomes, with adverse events monitored continuously by a Data Safety Monitoring Board. All coronary angiographies and interventions are reviewed by an independent core laboratory to assess adherence to implantation techniques. The primary outcome measured is device-oriented cardiac events at one year, with study participation lasting at least one year to ensure follow-up and compliance.

Age: 18Years +All Genders
17 locations