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Found 4 Actively Recruiting clinical trials

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Researchers are evaluating whether amino acid supplementation combined with a structured diet and exercise program can improve body composition and physical performance in adults with facioscapulohumeral muscular dystrophy FSHD. This rare muscle disease causes progressive weakness mainly in the face, shoulders, and upper body, leading to reduced strength, aerobic capacity, walking ability, and increased fatigue. The study also compares responses between people with FSHD and healthy individuals matched by age and sex. Participants with FSHD will undergo two 6-month treatment phases with a 3-month break in between, receiving either amino acid supplements or placebo in random order. Healthy volunteers will complete one 6-month phase receiving exercise and diet only. All participants follow a personalized diet and home-based exercise plan including aerobic and resistance training. The amino acid supplement is given twice daily under blinded conditions. Throughout the 15-month study period, researchers will assess body composition, muscle strength, aerobic fitness, walking performance, and daily physical activity using tools like handgrip strength tests, gait analysis, VO2 max measurement, and accelerometers. Safety is monitored mainly for minor injuries related to exercise. The study aims to measure changes in fat mass, lean mass, aerobic capacity, muscle strength, and walking ability from start to end of treatment.

Age: 18Years - 50YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

Researchers are studying patients experiencing arrhythmic storm, a serious heart condition characterized by frequent and sustained ventricular arrhythmias that do not respond to standard antiarrhythmic drugs. This international multicenter observational study aims to evaluate the safety and effectiveness of Percutaneous Stellate Ganglion Block PSGB in reducing arrhythmic relapses in such emergency cases. The study is coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, and addresses a gap in large-scale data on this procedure. Participants who meet the criteria will receive PSGB using either the anatomical or echo-guided approach. Depending on patient needs, the procedure may involve a single anesthetic injection or continuous anesthetic infusion via a catheter connected to a pump. The study compares the number of arrhythmic events and defibrillations before and after PSGB treatment and notes any complications occurring within 12 hours post-procedure. During participation, patients will be monitored closely for arrhythmic relapses using defibrillation counts and anti-tachycardia pacing data. Complications such as hematomas, vascular injuries, and nerve damage will be recorded. Data are collected using a secure electronic system, with effectiveness measured by arrhythmic event reduction in the 12 hours following PSGB compared to the 12 hours prior. The study plans to enroll patients over several years with ongoing safety and outcome evaluations.

All Genders
38 locations
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Actively Recruiting

Mild traumatic brain injury TBI is a common reason for visits to emergency departments EDs. Researchers are studying how brain computed tomography CT scans are used in Italian EDs to assess patients with mild TBI. The study aims to understand the variability in CT use, validate existing clinical decision tools, and develop a new model to predict medium-term outcomes for patients with mild head trauma. The study observes adult patients who come to the ED with mild head trauma, defined by a Glasgow Coma Scale score between 13 and 15. Patients with longer-lasting loss of consciousness or amnesia are excluded. Researchers will analyze when and how CT scans are used and compare this with guidelines such as the Canadian CT Head Rule and others. They will also validate current scoring systems and work on creating an improved decision-making tool to help doctors decide when CT scans are necessary. Participants will be monitored from September 2025 through August 2027. During this time, researchers will assess CT scan use, validate common scoring methods, and develop a new score. The study involves reviewing patient data and clinical outcomes to better understand the best practices in managing mild TBI in the ED. This research aims to improve patient care by reducing unnecessary CT scans while identifying those at risk of serious complications.

Age: 18Years +All Genders
24 locations
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Actively Recruiting

Researchers are evaluating the performance and safety of the medical device 047 TD Dermatitis cream in adults and children with atopic and contact dermatitis. The study aims to confirm that the cream helps improve these skin conditions by reducing disease severity and symptoms. The research uses a post-marketing clinical follow-up method involving questionnaires to collect and analyze patient data scientifically. Participants will apply the 047 TD Dermatitis cream twice daily for 28 days on the affected skin areas. The cream forms a protective layer on the skin to defend against environmental factors. Treatment effects will be assessed at various points during the 28-day period, including at 14 days and at the end of treatment. Participants will be monitored throughout the study with evaluations of eczema severity using the Eczema Area and Severity Index EASI, itch intensity using a visual analog scale VAS, and patient-reported assessments of anti-itch effects and quality of life. Adherence to treatment, product usability, overall device performance, and safety will be tracked from enrollment to day 28. The total participation lasts for 28 days with assessments at specified intervals.

Age: 6Months - 65YearsAll GendersPhase Not Applicable
3 locations