Visos

Bronchiectasis is a chronic lung condition marked by permanent widening of parts of the airway, causing mucus buildup, infections, and ongoing lung inflammation. This study evaluates whether using the SIMEOX device at home, combined with remote physiotherapy, can improve quality of life and reduce lung flare-ups in adults with non-cystic fibrosis bronchiectasis compared to enhanced standard care. The study is led by Physio-Assist and focuses on long-term effects over two years. Participants are randomly assigned to one of two groups one receiving standard care plus remote physiotherapy, and the other using the SIMEOX device along with remote physiotherapy and standard care. The SIMEOX device helps clear mucus by delivering short negative air pulses through a mouthpiece. Remote physiotherapy sessions occur once a month for the first three months, then every three months thereafter. Use of the SIMEOX device is recommended daily or more often if needed. During the 24-month study, participants will be assessed at multiple points for changes in respiratory quality of life using questionnaires like the SGRQ, as well as lung function tests and tracking the frequency of lung exacerbations and hospitalizations. Researchers will monitor compliance with the device, adverse events, and other health outcomes. This comprehensive follow-up aims to understand the devices impact on patient wellbeing and lung health over the long term.

Researchers are evaluating the long-term performance and reliability of Medtronics market-released cardiac rhythm therapy products, including leads and devices used for pacing, sensing, or defibrillation. This observational study aims to analyze how well these cardiac devices function over time by measuring survival probabilities and tracking device-related complications. The study applies to patients with conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. The study includes all Medtronic market-released cardiac leads and implantable devices such as pacemakers IPG, implantable cardioverter defibrillators ICD, and cardiac resynchronization therapy CRT devices. Participants either have a new implant or are within 30 days post-implantation. Data from prior qualifying Medtronic studies with complete follow-up may also be included. The study continuously monitors these products from the time of implant until the lead is no longer in use due to patient exit, death, or device deactivation. Participants provide consent for data access and use, and their health information is tracked over the long term. Researchers evaluate lead-related complications and product survival throughout the study period, which began in 1983 and is ongoing until 2040. The study does not involve additional treatments but collects follow-up data to assess device performance and safety over time.

Researchers are gathering ongoing information on the safety and performance of Medtronic products that are already available on the market. This registry study aims to support patients, hospitals, clinicians, regulators, payers, and the medical industry by simplifying the process of monitoring these products and providing up-to-date performance data. The study involves collecting data on patients who have received or are planned to receive Medtronic medical devices or therapies. Enrollment includes both prospective and retrospective participants within a specific time frame related to their therapy start. There are no specific interventions assigned, as this is an observational registry. Participants provide written consent and are followed periodically, typically every 6 to 12 months depending on the therapy, to assess the safety and effectiveness of their Medtronic product. Researchers collect information from medical records and follow-up visits to monitor outcomes over time. Participants may be followed for many years, with the study currently planned through January 2040.

Researchers are evaluating nucresiran in patients with transthyretin amyloidosis who have cardiomyopathy. The study aims to compare the effects of nucresiran versus a placebo on reducing death from any cause and cardiovascular events, as well as assessing patient-reported health status and quality of life. This is a Phase 3, global, randomized, double-blind study sponsored by Alnylam Pharmaceuticals. Participants receive either nucresiran 300 mg or a placebo injected under the skin every six months during the double-blind period. After this, all participants enter an open-label extension where they receive nucresiran 300 mg every six months. The study treatments are given subcutaneously and the double-blind phase is estimated to last about 32 months, with a possible maximum of 5 years. During the study, participants will be monitored for all-cause mortality and cardiovascular events such as hospitalizations and urgent heart failure visits. Quality of life and health status will be assessed using the Kansas City Cardiomyopathy Questionnaire. Regular evaluations include tracking recurrent cardiovascular events and changes in heart failure symptoms. Safety and health will be followed throughout the double-blind and extension periods, with a maximum participation length of about 5 years.

Researchers are evaluating whether the drug zilebesiran can reduce major cardiovascular events such as cardiovascular death, nonfatal heart attacks, strokes, and heart failure episodes in adults with hypertension that is not well controlled and who either have established cardiovascular disease or are at high risk for it. This phase 3, randomized, double-blind study aims to gather sufficient clinical outcome events to determine the drugs impact compared to placebo. Participants will receive either 300 mg of zilebesiran or a placebo through subcutaneous injection every six months, in addition to their usual antihypertensive medications that include at least two standard drugs, one being a diuretic. The study treatments are given as add-on therapy alongside the participants existing blood pressure management. The study will continue until enough cardiovascular events have occurred to assess the primary outcome. During the study, participants will be monitored for up to approximately five years. Researchers will track the time to the first occurrence of a combined endpoint including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure events requiring hospitalization or urgent visits. Blood pressure changes will also be measured at six months. Safety and efficacy will be closely followed through regular visits and assessments. The long follow-up period allows for thorough evaluation of cardiovascular outcomes and treatment effects.