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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Type 1 Diabetes Mellitus (T1DM) is an autoimmune disease that destroys insulin-producing pancreatic beta cells, leading to reliance on daily insulin injections and dietary management. This research evaluates the effect of Hyperbaric Oxygen Therapy (HBOT) on immune system balance, beta cell function, and blood sugar control in children and young adults newly diagnosed with T1DM within the past 12 weeks. The study aims to understand if HBOT can help preserve beta cell function and improve clinical outcomes, including insulin use and quality of life. Participants are randomly assigned to receive either HBOT or standard care. The HBOT group undergoes 60 sessions over 12 weeks, receiving 100% oxygen at 2 ATA for 90 minutes with brief air breaks every 20 minutes, five days a week. Both groups continue standard diabetes management with insulin given before meals based on carbohydrate counting and continuous glucose monitoring. The study includes 12 weeks of intensive treatment followed by 12 weeks of follow-up. Throughout the 24-week study, researchers assess immune cells, inflammatory markers, beta cell function via C-peptide levels, blood sugar control through continuous glucose monitoring and HbA1c tests, insulin doses, and changes in gut microbiome from stool samples. Safety and adherence are monitored, and outcomes focus on immune response, beta cell reserve, and glycemic control to evaluate the potential benefits of HBOT in new-onset T1DM.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate the performance and safety of AnGelHA 2 filler for treating moderate to severe wrinkles and folds and for facial contour remodeling in everyday clinical practice. It is a post-market, prospective, non-interventional, and open-label study that includes adults 18 years and older who are willing to undergo non-surgical aesthetic procedures with AnGelHA 2. The study focuses on real-world use of this filler to assess its effects and safety over time. Participants receive AnGelHA 2 injections based on routine clinical practice without specific restrictions on injection technique, volume, or treatment area. Treatments may address one or multiple indications, and re-treatment is allowed throughout the study duration as per usual care. The decision on injection depth, volume, and technique is left to the healthcare provider's discretion. The study involves an initial baseline visit followed by optional follow-up visits at 1, 3, 6, 9, and 12 months. Additional visits can occur if requested by the participant or deemed necessary. At each visit, safety assessments are conducted, and the performance of the filler is evaluated on treated areas and overall facial appearance. The primary outcome measured is the number of participants showing improvement in the Investigator Global Aesthetic Improvement Scale (iGAIS) up to 56 weeks after treatment.