Coconut Creek

Researchers are evaluating the safety and effectiveness of astegolimab compared to a placebo in adults aged 40 to 80 years who have chronic obstructive pulmonary disease (COPD). The study focuses on participants who are former or current smokers with a history of frequent COPD flare-ups. This phase III trial aims to determine how well astegolimab reduces moderate and severe COPD exacerbations over one year. Participants will be randomly assigned to receive either subcutaneous astegolimab every two or four weeks or a placebo every two weeks. All participants will continue their optimized COPD maintenance treatments, which may include combinations of inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists. Study treatments will be administered over a 52-week period. Throughout the study, researchers will monitor the annual rate of moderate and severe COPD exacerbations. Participants will undergo lung function tests, chest imaging, and assessments of breathlessness and lung health. The study will also carefully track the safety of the treatments, including any infections or heart-related problems. The total participation time is 52 weeks, during which the effectiveness and safety of astegolimab will be evaluated.

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Researchers are evaluating a noninvasive eye measurement technique called Dynamic Light Scattering Spectroscopy to detect differences between patients with and without dementia. The study aims to find out if this method can identify various types of dementia and their stages early on by measuring molecular changes in the retina, which is an extension of the brain. Dementia includes conditions such as Alzheimer's disease, vascular dementia, Lewy body dementia, and others, which cause loss of mental abilities and memory. The study involves a single office visit where participants undergo pupil dilation in one eye chosen by the patient. After dilation, a 5-second Dynamic Light Scattering measurement is taken using a specialized device combined with a standard fundus camera. This procedure is designed to use very low levels of light and takes about 5 minutes total. The pupil dilation typically wears off in 2 to 3 hours after the measurement. Participants will be evaluated through an ophthalmic exam for suitability and stability, and measurements will be taken to compare differences between those with dementia and those without neurological conditions. The main outcome measured is the difference in the Dynamic Light Scattering results between groups. Data confidentiality will be maintained, and safety is monitored throughout. The study plans to enroll 50 adults, half with dementia and half without, and the total participation lasts for the duration of the measurement visit.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the effectiveness of adding Miro3D Wound Matrix to standard wound care compared to standard care alone for patients with Wagner Grade 1 diabetic foot ulcers or wound dehiscence. This prospective, randomized controlled trial aims to see if combining Miro3D—a three-dimensional, acellular porcine-derived wound scaffold—with standard treatment improves early healing outcomes at four weeks, which can predict complete healing by twelve weeks. The study involves about 30 adults with these types of wounds and focuses on improving healing rates and wound outcomes in an outpatient setting. Participants will be randomly assigned to two groups: one receiving weekly Miro3D applications for four weeks, then biweekly if needed, along with standard care for up to twelve weeks; the other receiving standard care alone. If wounds in the standard care group remain unhealed after twelve weeks, those participants may switch to receive Miro3D treatment on the same schedule for an additional twelve weeks. Standard care includes wound cleaning, debridement, infection management, protective dressings, and pressure relief devices. Throughout the study, participants will attend weekly visits for up to twelve weeks to have their wounds assessed through imaging and measurements, clinical examinations, and pain evaluations. Quality of life and adverse events will also be monitored. Healed wounds will be confirmed with follow-up visits two and four weeks after closure. The main outcome measured is the percent reduction in wound area and formation of new granulation tissue at four weeks, as indicators of healing progress by twelve weeks. Safety and treatment effectiveness data will be collected and analyzed to support the role of Miro3D in wound healing.

Researchers are evaluating the performance of two new blood-based tests designed to help detect cancer in adults aged 45 and older who show symptoms or signs that suggest cancer might be present. These tests focus on multiple cancers, including those in the gastrointestinal system, to improve early diagnosis and guide further medical evaluation. Participants will have up to 40 mL of blood collected for analysis with the investigational diagnostic tests. For those suspected of having cancer, standard diagnostic procedures will be followed to confirm the diagnosis, while participants already diagnosed with cancer must not have started treatment prior to enrollment. The results of the investigational tests will be kept confidential and will not influence clinical care decisions, ensuring unbiased evaluation. During the 18 months following enrollment, researchers will assess the accuracy and performance of these diagnostic tests by comparing their results with clinical diagnoses confirmed through standard care. Participants may undergo routine clinical evaluations, imaging, and pathology reviews as part of their care. The study team will monitor outcomes and maintain blinding to test results to ensure objective assessment throughout the study period.

Researchers are evaluating the Miro3D Wound Matrix, a biologic dressing made from porcine liver tissue, to support healing in adults with difficult wounds and ulcers. This post-market, proof-of-concept trial focuses on complex wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, and surgical wound dehiscence, including those with tunneling or undermining. The study aims to assess how well Miro3D works alongside standard wound care to promote wound closure and reduce pain and discomfort in outpatient settings. Participants will receive standard wound care plus weekly applications of Miro3D for the first 4 weeks. If the wound is not fully healed by then, Miro3D will be applied every two weeks until healing or up to 12 weeks total. The Miro3D matrix is a sterile, acellular, three-dimensional scaffold applied topically after wound debridement. The study involves weekly visits for wound assessment and repeated Miro3D applications as needed. If healing occurs earlier, participants complete the study at that time. During the 12-week treatment phase, researchers will measure wound size reduction and granulation tissue formation at 4 and 12 weeks. Participants will complete weekly questionnaires about pain and quality of life to understand treatment impact on physical function, emotional wellbeing, and social engagement. Safety monitoring will include tracking any adverse events. The study will end early for participants whose wounds heal before 12 weeks or who withdraw. Data collected includes wound characteristics, treatment details, and patient-reported outcomes to evaluate the Miro3D's role in wound healing.