Ocean City

Researchers are gathering information on patients with eosinophilic esophagitis (EoE) who have recently started treatment with DUPIXENT4 (dupilumab). This study aims to understand how DUPIXENT is used in everyday medical care for EoE patients. The research also seeks to improve knowledge about EoE to support future studies and treatment decisions for this condition. Participants will receive dupilumab as it is normally prescribed by their healthcare providers, with no additional study drugs provided by the sponsor. The study is observational, meaning the treatment is given as part of standard care without experimental changes. There are no separate treatment groups or interventions beyond regular clinical use. Participants will complete questionnaires that assess how EoE affects their feelings, symptoms like swallowing difficulty, quality of life, and daily activities. Researchers will also collect information on demographics, disease history, medication use, and medical procedures over a period up to three years after starting dupilumab. This helps monitor treatment patterns and disease changes over time.

Researchers are evaluating the effects of two inhalers, budesonide/albuterol metered-dose inhaler (BDA MDI) and albuterol sulfate metered-dose inhaler (AS MDI), both taken as needed, on reducing severe asthma attacks in adolescents aged 12 to under 18 years who have a clinical diagnosis of asthma and have experienced at least one severe asthma exacerbation in the past year. This is a Phase IIIb randomized, double-blind, multicenter study lasting 52 weeks with a safety follow-up period after treatment. Participants will be randomly assigned to receive either BDA MDI 160/180 micrograms (two puffs of 80/90 micrograms) or AS MDI 180 micrograms (two puffs of 90 micrograms) as needed, alongside their usual asthma maintenance therapy, for 52 weeks. The study includes a 7 to 28-day screening period before treatment and a safety follow-up visit 7 to 14 days after the end of treatment. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered after the safety follow-up. During the study, participants will be monitored for the annual rate of severe asthma exacerbations from randomization to week 52. Assessments include evaluating inhaler technique, peak expiratory flow measurements, and adherence to contraception methods for participants of childbearing potential. Safety will be monitored throughout the treatment and follow-up periods. The total study duration includes screening, 52 weeks of treatment, and safety follow-up.

Researchers are evaluating the long-term reliability and performance of Medtronic cardiac rhythm products, including leads and devices used for pacing, sensing, or defibrillation. The study aims to analyze product survival probabilities to better understand their durability and performance over time. This research includes all Medtronic market-released leads and implantable devices for conditions such as arrhythmia, bradycardia, heart failure, and sinus tachycardia. Participants include those who have been implanted with at least one Medtronic market-released product or those who participated in qualifying Medtronic studies with complete implant and follow-up data. The study monitors these devices from the time of implant, tracking lead-related complications and device performance. If a patient exits the study, passes away, or the device is deactivated, the implant is no longer followed. During the study, researchers collect health information and monitor the devices to assess ongoing performance and complications. Follow-up is essential to confirm device status and ensure accurate data collection. The main outcome measured is lead-related complications for each lead model, with continuous observation from implant until termination due to patient or device status. Participation requires informed consent and authorization for access to health information as per institutional requirements.

Researchers are evaluating the effects of Taplucainium Inhalation Powder (NOC-110) in adults aged 18 to 80 who have refractory or unexplained chronic cough lasting at least 12 months. This phase 2b study aims to assess the medicine's efficacy, safety, and tolerability compared to a placebo in a randomized, double-blind, controlled setting. The study will involve about 455 participants, with up to 1264 screened to identify eligible adults. Participants will receive either NOC-110 inhalation powder or a matching placebo once daily during the treatment period. The study includes a screening phase followed by approximately 13 weeks of participation, during which participants will use the assigned inhalation powder. The trial is designed to monitor how the treatments impact cough frequency and overall tolerability over this period. Throughout the study, participants will be closely monitored for changes in their 24-hour cough rates, measured from baseline to the end of treatment. Researchers will also assess safety and any side effects. Participants will provide informed consent and follow contraceptive guidance if applicable. The study includes detailed tracking of medical history, respiratory health, and other relevant factors to ensure participant safety and gather comprehensive data on treatment effects.