New Smyrna Beach

This study involves patients who have had previous acute coronary syndrome ACS events and are at high risk for recurrent ACS. It aims to evaluate the AngelMed Guardian System, an implantable cardiac monitor that alerts patients to potential ongoing ACS events. The study will assess the devices diagnostic accuracy, physician compliance, patient compliance with alerts, and the adequacy of training programs for physicians and patients. Participants will be implanted with the AngelMed Guardian System and receive standard care, including an initial programming visit 7 to 14 days after implantation and follow-up visits every 6 months. The study is event-based and will continue until 314 adjudicated true or false positive ACS events have been collected. The device detects sustained ST segment changes and alerts patients to seek medical attention for potential ACS events, including asymptomatic ones. During the study, patients will have regular in-office visits for device programming and monitoring. Researchers will track the occurrence of ACS events, patient and physician responses to alerts, and the effectiveness of training programs. The main outcome measures include the devices positive predictive value and false positive rate. The study will last for approximately 3 years, with follow-up visits every 6 months until study completion or exit.

Researchers are evaluating the bioequivalence of two eye drop treatments, Bimatoprost 0.01% ophthalmic solution by Amneal EU and LUMIGAN4 bimatoprost ophthalmic solution 0.01% by Allergan, in adults with chronic open-angle glaucoma or ocular hypertension affecting both eyes. This randomized, double-blind, parallel-group study aims to compare these treatments by measuring their effects on intraocular pressure IOP as the primary clinical endpoint. Participants will be randomly assigned to receive either the test or reference bimatoprost eye drops, instilling one drop in both eyes every evening around 1000 pm for 42 days. The study includes multiple doses over this period, with evaluations occurring at baseline, two weeks, and six weeks. The test and reference products are both ophthalmic solutions containing the same concentration of bimatoprost. Throughout the study, participants will have clinical assessments to monitor safety and efficacy, including IOP measurements at specific times 0000, 0400, and 0800 hours on days 14 and 42. Safety monitoring for adverse events will continue during the six-week treatment period. The main outcome is the mean difference in IOP between the treatment groups, helping to determine if the test product is equivalent to the reference product in controlling eye pressure.

This research aims to evaluate the sensitivity of the DermaSensor device and investigators in detecting melanoma from suspicious skin lesions. The study focuses on men and women aged 40 and older who have skin lesions that may be melanoma, assessing how well the device and clinical exam can identify concerning lesions. Participants are divided into two groups one where primary care investigators assess suspicious lesions and decide to biopsy without the devices input, and another where the devices output informs the biopsy decision. The DermaSensor uses elastic scattering spectroscopy, which analyzes light reflected from the lesion to compare it to known benign or malignant patterns. During the study, participants will have their skin lesions examined either with or without the devices assistance. Researchers will measure how sensitive the device is in detecting melanoma over 39 months. Patients will be monitored through the study period to observe the diagnostic process and outcomes, ensuring proper follow-up and safety.