Massa

Researchers are evaluating the SensMode System, a set of wearable devices designed to analyze upper and lower limb movements. This study involves healthy adults, subjects with idiopathic hyposmia, patients with Parkinsons disease, and individuals with newly diagnosed drug-nafve extrapyramidal syndrome. The goal is to establish normal ranges for objective motor measurements and explore how this technology might aid in early diagnosis and management of Parkinsons disease. Participants will use the SensMode System, which includes SensHand and SensFoot devices. SensHand consists of sensorized rings and a wristband that measure movement and orientation of the hand and forearm, while SensFoot is a device placed over the shoe to assess lower limb motion. All subjects undergo motor analysis using these sensors at enrollment. During the study, researchers will monitor various motor outcome measures such as the number of repetitions of specific movements, time to stand up, gait time, rotation time, fundamental frequencies from accelerometer signals, and stride count at enrollment. This data will help characterize motor function and support further research into Parkinsons disease diagnosis and care. The study runs from May 2024 to January 2026 and includes adults aged 50 to 80 years.

Researchers are conducting a large prospective, observational cohort study to evaluate the clinical impact of new Monoclonal Antibodies MAB in patients with B-cell Non-Hodgkin Lymphoma NHL treated in Italian clinical practice. The study focuses on collecting information about the use, feasibility, effectiveness, and both short- and long-term side effects of novel MABs that have been approved by the European Medicines Agency since 2020 and prescribed according to authorized indications in Italy. Participants will be divided into groups based on treatment indication, antibody type, and lymphoma subtype to allow detailed analysis. The study observes patients with B-cell NHL who have received at least one dose of a novel MAB either alone or in combination, as authorized for use in Italy. Both patients receiving first-line treatment and those with relapsed or refractory disease are included. Various cohorts and sub-cohorts will be analyzed to understand outcomes by indication, antibody type, and histological subtype, providing a comprehensive overview of these treatments in real-life settings. Participants will be followed for at least five years to assess outcomes such as overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and the incidence of early and late adverse events. Clinical data collection will include treatment details, safety monitoring, and long-term follow-up to evaluate both effectiveness and toxicity. The study spans several years, allowing researchers to capture extensive real-world evidence on novel MAB use in B-cell NHL.

Researchers are evaluating the effects of ninerafaxstat in adults with symptomatic non-obstructive hypertrophic cardiomyopathy nHCM, a heart condition characterized by thickened heart muscle without obstruction. This global Phase 2b study aims to assess the safety and effectiveness of ninerafaxstat compared to a placebo, both given alongside standard care, to improve symptoms and heart function. The trial is double-blinded and placebo-controlled to ensure reliable comparisons between groups. Participants will be randomly assigned to receive either ninerafaxstat 200mg modified release tablets or matching placebo tablets, both taken twice daily. The study treatment will be given over a 12-week period. This design helps researchers observe how ninerafaxstat performs against placebo while maintaining standard therapies for nHCM. During the study, participants will undergo assessments including cardiopulmonary exercise testing and completion of the Kansas City Cardiomyopathy Questionnaire to track symptoms, physical limitations, and overall health status. The main focus is on changes in the questionnaires clinical summary score from baseline to week 12. Safety and tolerability will also be monitored throughout the trial, which is expected to run until December 2026.

Researchers are conducting a Phase 12 open-label study to evaluate the safety, tolerability, and efficacy of ALXN2350, a gene therapy, in adults with BAG3 mutation associated dilated cardiomyopathy DCM. This study focuses on adults aged 18 to 70 years who have this specific genetic form of DCM and aims to understand the effects of a single intravenous infusion of ALXN2350. Participants receive one of three dose levels of ALXN2350 depending on their cohort. ALXN2350 consists of an AAV9 capsid containing the BAG3 transgene and is given as a single intravenous infusion. The study includes dose finding and dose expansion phases to assess the therapys effects over time. During the study, participants are monitored for treatment emergent adverse events and serious adverse events from baseline up to Week 78. Cardiac events and time to first major cardiac outcomes such as death, heart transplant, mechanical support, or aborted sudden cardiac death are also tracked. The total study duration for each participant extends up to 78 weeks, with close follow-up to evaluate safety and efficacy.

Researchers are evaluating the clinical characteristics and procedural outcomes of patients receiving permanent cardiac pacing to treat various heart rhythm disorders. This observational study compares the effectiveness and safety of different device implantation methods used in routine clinical practice, including the contribution of advanced non-fluoroscopic anatomical and electrophysiological mapping systems. The study focuses on patients over 18 years old who require a pacemaker or intracardiac defibrillator implant following European Society of Cardiology guidelines. The study includes several types of cardiac pacing approaches conventional right ventricular pacing, conduction system pacing such as His bundle or left bundle branch area pacing, cardiac resynchronization therapy CRT with biventricular or left ventricular pacing, epicardial pacing often done during cardiac surgery, and leadless pacing via a percutaneous femoral vein approach. Each method involves implantation of a device connected to cardiac leads positioned in specific heart locations, with vascular access through veins like the cephalic, axillary, or subclavian. Electrical parameters such as pacing threshold and sensing are measured to ensure device stability before final placement. Participants will be followed for up to 120 months with clinical and procedural data collected, including assessments of device efficacy and safety at 30 days, 6 months, and 12 months. Outcome measures include stable electrical device performance, absence of cardiovascular hospitalizations or death, and monitoring for heart failure or arrhythmia events. The study also tracks procedural times, radiation exposure, and complications such as infections or lead dislocations. This long-term observation aims to understand the benefits and risks of various pacing strategies in real-world settings.

Researchers are conducting a global, prospective, multi-center post-market clinical follow-up study called MANTRA to monitor the safety and performance of CORCYM devices and accessories used for aortic, mitral, and tricuspid valve diseases in real-world settings. This umbrella protocol allows multiple sub-studies to be added, covering the sponsors entire cardiac surgery heart valve portfolio and including core lab assessments for some products. The study plans to enroll about 2150 subjects across up to 130 sites worldwide. The study includes three sub-studies the Aortic Sub-Study, the MitralTricuspid Sub-Study excluding Memo 4D, and the Memo 4D Sub-Study. Subjects diagnosed with valve diseases and considered suitable for treatment with specific CORCYM devices can participate in the corresponding sub-study. Follow-up visits are planned at discharge, 30 days post-implantation, and annually for up to 10 years. The Memo 4D sub-study involves additional echocardiogram imaging assessed by a core lab. Participants will provide informed consent and share baseline, procedural, hospitalization, discharge, and follow-up data during standard medical care. They will complete quality of life questionnaires at baseline, 30 days, and one year. Researchers will monitor device success at 30 days as the primary outcome and track mortality, adverse cardiovascular events, rehospitalizations, valve function, and patient outcomes up to 10 years. Safety and performance data will be collected continuously throughout the study.

This registry observes patients with heart valve disease who have undergone or are planned to undergo surgical heart valve repair or replacement. The purpose is to support ongoing post-market surveillance of these devices by monitoring their performance and safety over time. Participants receive surgical heart valve repair or replacement products as part of their standard care. This study collects information about patients treated with these devices, either prospectively at the time of surgery or retrospectively if treated earlier. The registry follows patients long-term to identify any unique failure modes or adverse device effects. During the study, patients are monitored for up to 10 years to assess device performance and safety trends. Researchers collect data through follow-up visits and medical records to track outcomes related to the surgical valve products. The study helps improve understanding of device durability and safety in real-world patient use.

Researchers are collecting data to evaluate the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in repairing the mitral valve through a minimally invasive procedure called transcatheter mitral valve repair. The study focuses on patients with mitral regurgitation to understand how well these devices improve valve function, symptoms, and quality of life in real-world settings after market approval. Participants receive treatment using either the Edwards PASCAL System or the Edwards PASCAL Precision System for transcatheter mitral valve repair. This study is conducted in a postmarket clinical follow-up format, meaning the devices are already approved and are now being further studied to gather safety and effectiveness data over time. During the study, patients will be monitored for major adverse events within 30 days and assessed for changes in mitral regurgitation severity by echocardiography at discharge or 7 days after the procedure. Participants will also attend follow-up visits where functional status and quality of life will be evaluated. The study aims to collect comprehensive safety and effectiveness information over the course of participation, which begins after the mitral valve repair procedure and continues through scheduled follow-ups.

Researchers are studying how best to manage patients with low blood pressure due to traumatic injuries before they reach the hospital. The study focuses on patients helped by helicopter emergency medical services HEMS across Italy, where emergency care practices vary widely. The goal is to understand how prehospital treatments affect hospital recovery and survival, especially for those with severe bleeding and shock. The study observes different prehospital treatments such as drug use including antifibrinolytics, pain relief, sedatives, and muscle relaxants. It also looks at advanced techniques like resuscitative endovascular balloon occlusion of the aorta REBOA, blood transfusions, and ultrasound assessments for trauma. Care strategies like staying on scene for treatment versus rapid transport are also compared as part of usual prehospital management. Participants will have detailed data collected from the prehospital phase including demographics, trauma type, and treatments given. Hospital data such as blood transfusions, lab results, length of hospital and ICU stays, use of ventilation or kidney support, recovery, and survival will be analyzed. The main outcome measured is mortality within 30 days, with secondary outcomes including survival to hospital admission, hospital stay length, blood products used, and transport times. The study started in May 2021 and will continue until May 2026.