Massa

This research aims to use the SensMode System, which includes wearable devices for analyzing upper and lower limb movements, to study healthy adults, individuals with idiopathic hyposmia, patients with Parkinson's disease, and subjects with new untreated extrapyramidal syndrome. The goal is to establish normal motor measurement data and explore how this technology can aid in early diagnosis and management of Parkinson's disease. The SensMode System consists of two main devices: SensHand for upper limb motion analysis and SensFoot for lower limb monitoring. SensHand includes sensorized rings for the thumb and forefinger and a wristband that measure acceleration, angular velocity, and magnetic fields related to arm and hand biomechanics. SensFoot is worn over the shoe and contains similar sensors to capture lower limb movement data. Participants will be evaluated using various motor tests at enrollment, including measuring repetitions, time to stand up, gait time, rotation time, accelerometer signal frequencies, and stride count. The study involves collecting objective motor data to better understand movement patterns. Healthy subjects and Parkinson's patients aged 50 to 80 years will provide informed consent and undergo assessments to monitor motor function and neurological status throughout participation.

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include 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 incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are evaluating the clinical characteristics and procedural efficacy and safety of different permanent cardiac pacing implantation approaches in patients over 18 years old who need a pacemaker or intracardiac defibrillator. The study focuses on various pacing methods including right chamber endocardial pacing, epicardial pacing, cardiac resynchronization therapy (CRT), conduction system pacing (CSP), and leadless pacing. The study aims to understand how these methods affect patient survival and quality of life, as well as the potential benefits of non-fluoroscopic anatomical and electrophysiological systems during implantation. Participants will receive permanent cardiac pacing devices according to European Society of Cardiology guidelines. The pacing types studied include conventional right ventricular pacing, conduction system pacing (such as His bundle and left bundle branch area pacing), CRT involving biventricular or left ventricular pacing, epicardial pacing, and leadless pacing. The study will observe the safety and effectiveness of these modalities at 30 days, 6 months, and 12 months, considering factors like stable electrical parameters, absence of hospitalizations, and device-related complications. During the study, researchers will collect clinical and procedural data from patients who have undergone device implantation at participating centers over a 10-year period, with an equal follow-up duration. Assessments will include monitoring device function, hospitalizations for heart failure, all-cause mortality, heart failure occurrence, and arrhythmias. Safety evaluations will track procedural complications, infections, and need for re-intervention. This comprehensive data collection aims to improve understanding of pacing methods and their impact on patient outcomes.

Researchers are evaluating the ongoing safety and performance of CORCYM devices and accessories used to treat aortic, mitral, and tricuspid valve diseases in a real-world setting. This global, multi-center, prospective post-market clinical follow-up study, called MANTRA, uses an overarching Master Protocol that allows multiple sub-studies to be conducted and combined for comprehensive data collection. The study aims to provide long-term information on the heart valve products offered by Corcym S.r.l., a manufacturer specializing in solutions for cardiac surgeons. The trial includes three sub-studies focusing on different valves: the Aortic Sub-Study, the Mitral/Tricuspid Sub-Study (excluding Memo 4D), and the Memo 4D Sub-Study. Approximately 2,150 subjects will be enrolled worldwide, with treatments given according to the device instructions for use and at the investigator's discretion. The study collects data during standard medical care without additional interventions. The Memo 4D sub-study involves specialized echocardiogram imaging assessed by a Core Laboratory to monitor device performance and heart valve dynamics. Participants will be followed up at hospital discharge, 30 days after device implantation, and then annually for up to 10 years. Data collected include informed consent, baseline demographics and medical history, procedural details, hospitalization and discharge information, and follow-up data. Quality of life questionnaires will be completed at baseline, 30 days, and one year. The primary outcomes measure the number and percentage of subjects achieving device success 30 days after implantation. Safety events and device deficiencies will also be monitored throughout the study period.

Researchers are conducting a registry study to support ongoing post-market surveillance of surgical heart valve devices used in treating valve disease of the heart. The study aims to monitor and identify unique failure modes and trends in adverse effects related to these devices over a period of 10 years. This long-term follow-up helps ensure continued safety and performance of the products after they have been approved for use. Participants in this registry receive surgical heart valve repair or replacement products made by Medtronic. The study includes patients who have already been treated or are intended to receive these eligible devices. Enrollment can occur during a specific window after treatment or retrospectively. The study focuses on collecting data related to the device performance and patient outcomes in real-world clinical use. During the study, participants will be followed for up to 10 years to track any device-related issues or adverse effects. Researchers will collect information through regular follow-up assessments, monitoring the safety and effectiveness of the heart valve devices. The registry allows for long-term data collection to better understand the durability and risks associated with these surgical heart valve products.

This research aims to collect data on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in repairing mitral valve problems, specifically mitral regurgitation and mitral insufficiency. The study focuses on patients who have undergone transcatheter mitral valve repair, evaluating how well these devices improve mitral regurgitation, functional status, and quality of life in a real-world, postmarket setting. Participants will receive treatment using the Edwards PASCAL and PASCAL Precision Transcatheter Valve Repair Systems for mitral valve repair. This study does not involve randomization or comparison groups but follows patients after their valve repair procedure to monitor outcomes. The devices are used according to approved indications after careful patient selection by a Heart Team. During the study, participants will attend follow-up visits where researchers will assess safety by tracking major adverse events within 30 days and evaluate effectiveness through changes in mitral regurgitation severity measured by echocardiography at discharge or seven days post-procedure. The study also monitors improvements in functional status and quality of life over time, requiring participants to complete all scheduled tests and visits to provide comprehensive data on the devices' performance.

Researchers are studying how best to treat trauma patients with low blood pressure (hypotension) before they reach the hospital, focusing on how different prehospital care methods affect recovery and survival in the hospital. The study addresses gaps in evidence about treatments like prehospital blood transfusions and resuscitative endovascular balloon occlusion of the aorta (REBOA). It also examines the variability in emergency medical services across Italy, especially in helicopter emergency medical services (HEMS), and how these differences might impact patient outcomes. Participants will receive various treatments during prehospital care, including drugs such as antifibrinolytics, analgesics, sedatives, and neuromuscular blockers; devices like REBOA and extended focused assessment sonography for trauma (eFAST); blood transfusions; and different management strategies like "stay and play" versus "scoop and run." Each patient’s demographic information, trauma type, injury severity, and therapies used will be recorded for analysis. Throughout the study, researchers will collect data on hospital outcomes such as the need for blood transfusions, blood gas parameters, length of hospital and ICU stays, use of invasive ventilation and kidney support therapies, recovery progress, and mortality within 30 days. This comprehensive monitoring aims to identify factors during prehospital care that relate to survival and recovery after trauma, with participant involvement lasting through hospitalization and follow-up for 30-day mortality.

Researchers are evaluating the safety, tolerability, and how the body responds to the drug BMS-986435/MYK-224 in adults with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF), a condition where the heart's pumping ability remains normal despite heart failure symptoms. This Phase 2A study aims to better understand the drug's effects and levels in the body in this specific group of heart failure patients. Participants will receive either BMS-986435 or a placebo, each given at specified doses on certain days. The study is designed as a double-blind, randomized, placebo-controlled trial conducted at multiple centers, ensuring unbiased evaluation of the drug's effects. The treatment period lasts approximately 24 weeks. During the study, participants will be closely monitored for any adverse events, including serious side effects and those that might lead to stopping treatment. The primary outcomes include tracking the incidence of these adverse events up to 24 weeks, with safety and tolerability being the main focus. Participants will be adults aged 40 to 85 with stable, symptomatic HFpEF, and the total involvement will cover the treatment and monitoring periods described.