New Smyrna Beach

The purpose of this prospective, non-randomized, single arm, event-based, multicenter trial is to assess: (1) the diagnostic accuracy of the device, (2) the compliance of the prescribing physician, (3) the experience of the implanting physician, (4) the experience of the emergency department physician and (5) the patient compliance for "Emergency" and "See Doctor" alerts. The adequacy of the training program for the prescribing physician, implanting physician, emergency department physician, and patients will be assessed. A minimum of 500 patients who have had prior ACS events and who remain at high risk for recurrent ACS events will be enrolled in the PAS, for the purpose of accruing 314 adjudicated True Positive (TP) or False Positive (FP) ACS events. These ACS events will contribute to the Positive Predictive Value (PPV) and false positive rate (FPR) endpoints of the study. The PAS will be completed once the 314 ACS events have been collected and adjudicated.

Researchers are evaluating the bioequivalence of two ophthalmic solutions containing 0.01% bimatoprost in adults with chronic open-angle glaucoma or ocular hypertension affecting both eyes. This Phase 3 randomized, double-blind, parallel-group study aims to compare the effects of a test drug from Amneal EU and the reference drug LUMIGAN4 (bimatoprost ophthalmic solution) in lowering intraocular pressure (IOP), a key factor in managing these eye conditions. Participants who meet specific criteria, such as having controlled IOP after washout and similar pressure between eyes, will be randomly assigned to receive either the test or reference drug. Each subject will apply one drop in each eye every evening around 10:00 pm for 42 days. The study involves multiple clinical sites and uses a parallel design with two treatment arms to assess the drugs' bioequivalence based on their clinical effect. Throughout the study, subjects will undergo clinical evaluations to monitor safety and effectiveness. The main outcome is the mean difference in IOP between the two treatment groups, measured at multiple times (00:00, 04:00, and 08:00 hours) on Days 14 and 42. Additional assessments include visual acuity tests and ongoing safety monitoring. The total treatment period is six weeks, with key measurements taken at two and six weeks after starting treatment.

Researchers are evaluating the sensitivity of the DermaSensor device and investigators in detecting melanoma from suspicious skin lesions. This study focuses on adults aged 40 and older who have primary skin lesions that may be melanoma. The purpose is to assess how well the DermaSensor device works in comparing lesion signatures to known benign or malignant pathology. Participants will have their suspicious skin lesions scanned using the DermaSensor, an elastic scattering spectroscopy device. This device uses a spectrum of light reflectance to analyze the lesion's characteristics by comparing them to a database of previously scanned lesions with known outcomes. The study does not involve additional treatments but focuses on device-based assessment. During the study, participants will undergo scanning of their suspicious lesions with the DermaSensor device. Researchers will monitor the sensitivity of the device over 39 months. Participants will be asked to provide informed consent and may need to attend follow-up visits as required. The study involves careful evaluation of lesion characteristics and device performance, with safety and adherence monitored throughout the study period.