Voghera

Researchers are evaluating whether taking amino acid supplements along with following a structured diet and exercise program can improve muscle mass, reduce fat, and enhance physical performance in adults with facioscapulohumeral muscular dystrophy (FSHD). This rare disease causes progressive muscle weakness mainly affecting the face, shoulders, and upper body, leading to reduced strength, endurance, walking ability, and increased fatigue. The study also compares the effects of this intervention between people with FSHD and healthy individuals matched by age and sex. The study involves a randomized, double-blind, placebo-controlled crossover design for participants with FSHD, who will receive both the amino acid supplement and a placebo in two separate 6-month phases, with a 3-month break in between. Healthy participants will undergo a single 6-month intervention phase. All participants will follow a personalized diet and home-based exercise program including moderate aerobic and resistance training. The amino acid supplement or placebo is taken twice daily under blinded conditions. Participants will be assessed at baseline and after each intervention phase for body composition, metabolic rate, muscle strength, walking performance, aerobic fitness, and daily physical activity using various tests and monitoring devices. The primary outcomes measured over 15 months include changes in fat mass, fat-free mass, aerobic capacity, muscle strength, and walking ability. Safety monitoring focuses on minimizing exercise-related risks, with guidance and supervision provided throughout the study period.

Researchers are conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are evaluating the use of Percutaneous Stellate Ganglion Block (PSGB) in patients experiencing arrhythmic storm, a serious emergency condition involving multiple sustained ventricular arrhythmias in 24 hours that do not respond to standard antiarrhythmic drugs. This international multicenter observational study, coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, aims to assess the safety and effectiveness of PSGB, which has limited large-scale evidence despite growing interest in neuromodulation treatments. Patients who meet the criteria will receive PSGB using one of two common approaches: the anatomical method, which targets Chassaignac's tubercle as the needle insertion point, or the echo-guided method. Depending on patient needs, the doctor may perform either a single injection of anesthetic or a continuous infusion via a catheter connected to a pump. This short-term study observes patients for 24 hours around the procedure. Participants’ arrhythmic episodes and the number of defibrillations will be recorded before and after PSGB to measure reduction in arrhythmic relapses within 12 hours post-procedure compared to 12 hours prior. Researchers will also track complications such as hematomas, vascular or nerve damage, and anesthetic side effects. Data will be collected electronically, and the study will monitor safety and effectiveness outcomes over time, potentially enrolling around 33 patients at the main center with expansion to other sites.

Researchers are evaluating the performance of the 047 TD Dermatitis cream in treating adults and children with atopic and contact dermatitis. The study aims to confirm whether the cream can reduce the severity and symptoms of these skin conditions by forming a protective layer on the skin that defends against environmental factors. This post-marketing clinical follow-up trial uses questionnaires and scientific methods to collect and analyze data related to patient experiences and treatment effects. Participants will apply the 047 TD Dermatitis cream twice daily for 28 days on the affected skin areas, using a sufficient amount and allowing it to dry. The study focuses on monitoring the cream's performance and safety during this treatment period. There are no comparator groups mentioned, and the treatment is delivered topically as a medical device. During the study, patients will be assessed for changes in disease severity and symptoms at the end of the 28-day treatment period. Researchers will collect data through questionnaires and clinical evaluations to measure performance outcomes. The total participation duration for each patient is 28 days, focusing on treatment effects and safety monitoring within this timeframe.