Lawrence Township

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

This research aims to develop and validate a single-gene Non-Invasive Prenatal Test sgNIPT to detect serious health conditions like cystic fibrosis, spinal muscular atrophy, sickle cell disease, and thalassemias in unborn babies. It focuses on pregnant people with higher risk pregnancies due to carrier status or affected conditions, including cases without reproductive partner screening. The study will gather blood samples and medical information from pregnant participants and, when applicable, their partners and newborns. Participants will undergo the investigational sgNIPT, which is designed for pregnant people whose fetus is at increased risk for a single-gene disorder. This includes situations where there is no partner screening, positive partner screening but no prenatal diagnostic testing, or ultrasound findings suggesting a single-gene disorder regardless of carrier status. The study will collect newborn cheek swabs and health data within six months after delivery as part of the research. During the study, participants will provide blood samples after nine weeks of pregnancy, and researchers will collect medical and genetic information from participants and their partners. Newborn health information and cheek swabs will be collected post-delivery to assess the tests performance. The primary outcome is the accuracy of the sgNIPT in detecting four main autosomal recessive disorders approximately two years after study launch, followed by evaluation of other single gene disorders about six months later. Participation involves consenting to these procedures and ongoing information sharing throughout the study period.

Researchers are studying the risk of progressive multifocal leukoencephalopathy PML, a rare brain infection caused by the John Cunningham virus JCV, in people with multiple sclerosis treated with ozanimod. The study aims to describe characteristics of patients who develop PML and estimate how often it occurs among those exposed to ozanimod. Factors such as age, duration of ozanimod use, previous immunosuppressant treatments, lymphopenia, and JCV antibody status will be evaluated for their association with PML. This observational study focuses on participants who have received at least one dose of ozanimod and developed PML. The study does not involve administering new treatments but collects and reviews reported cases from various sources including spontaneous reports, post-marketing observational studies, and patient support programs. PML cases must be confirmed as definite or probable and related to ozanimod by an adjudication committee. Participants are identified through adverse event reports from June 4, 2026, through July 31, 2041. Researchers will analyze patient data to determine the proportion of PML cases based on participant characteristics and potential risk factors over a follow-up period of up to 15 years. The incidence rate of PML among ozanimod-exposed patients will also be assessed. There is no direct participant involvement beyond data collection from reported cases.