Coconut Creek

Researchers are evaluating ibuzatrelvir, an oral medication, to determine its effectiveness and safety in adults and adolescents aged 12 years and older with COVID-19 who are not hospitalized but are at high risk for severe illness. The study is a phase 3, randomized, double-blind trial comparing ibuzatrelvir with a placebo. Participants must have confirmed SARS-CoV-2 infection with symptoms starting within 5 days and meet specific risk factor criteria based on age. Eligible participants will be randomly assigned to receive either ibuzatrelvir or a matching placebo twice daily by mouth for 5 days. The study allows co-administration of standard care treatments available locally. The total study duration is about 6 months, including follow-up. Participants will be monitored for emergency department visits related to COVID-19, hospitalizations, and mortality up to 28 days after starting treatment. Additional evaluations include symptom resolution, occurrence of long COVID symptoms, viral RNA levels, and safety measures such as adverse events through 24 weeks. The study involves regular assessments, including clinical visits and laboratory tests, to track outcomes and safety over time.

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 determine which types and stages of dementia can be identified using this method. Dementia includes various conditions such as Alzheimers disease, vascular dementia, Lewy body dementia, and others, which cause brain changes leading to memory loss and cognitive decline. The study involves an office-based procedure where patients undergo pupil dilation in one eye followed by a 5-second measurement using the dynamic light scattering device attached to a standard fundus camera. This technique measures subtle molecular changes in the retina, which is connected to the brain, to detect early signs of dementia. The study includes two groups patients diagnosed with dementia and age-matched individuals without cerebral pathology. Participants will have an ophthalmic history taken and undergo pupil dilation before the measurement. The test takes about 5 minutes, and the dilation effect lasts 2 to 3 hours. Researchers will collect and analyze data to compare measurements between groups. Safety monitoring is in place, and data confidentiality is maintained. The study is expected to enroll 50 patients and continue until recruitment is complete.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating whether adding the Miro3D Wound Matrix to standard care improves healing in adults with chronic diabetic foot ulcers. Diabetic foot ulcers are a serious complication of diabetes that may not heal well with usual treatment. This study compares healing outcomes between patients receiving Miro3D plus standard care and those receiving standard care alone, aiming to support wound healing and reduce complications such as infection and amputation. The trial enrolls about 180 adults with Wagner Grade 1 or 2 diabetic foot ulcers lasting between 4 weeks and 12 months. After a two-week screening period, participants are randomly assigned to one of two groups one receiving Miro3D Wound Matrix applied topically to the ulcer along with standard care, and the other receiving standard care alone. Standard care includes sharp debridement, offloading with a device, and moisture-retentive dressings. Participants are followed weekly for up to 12 weeks. During each weekly visit, researchers assess wound size, take photographs, check for infection, and measure pain using a numeric scale. Safety is monitored throughout by tracking adverse events. Some sites may also perform special imaging tests to explore tissue oxygenation and wound characteristics. The main outcomes measured are the rate of complete wound closure at 12 weeks and the percentage reduction in ulcer size. Secondary outcomes include pain changes and adverse events, with follow-up visits continuing as scheduled for up to 12 weeks.

Researchers are evaluating the effectiveness of Miro3D Wound Matrix combined with standard wound care compared to standard care alone in treating Wagner Grade 1 diabetic foot ulcers and wound dehiscence. Sponsored by Reprise Biomedical, Inc., this prospective, randomized controlled trial aims to determine whether adding Miro3D, a three-dimensional acellular porcine-derived wound matrix, improves early wound healing and overall outcomes in an outpatient setting. The study focuses on wound area reduction and granulation tissue formation at four weeks as predictors of healing by twelve weeks. Participants will be randomized into two groups one receiving Miro3D plus standard of care SOC and the other receiving SOC alone. In the Miro3D group, the device is applied weekly for four weeks, then biweekly if needed, for up to twelve weeks. The SOC group receives usual wound care like cleansing, debridement, dressings, and offloading. If wounds remain unhealed after twelve weeks in the SOC group, participants may crossover to receive Miro3D treatment for an additional twelve weeks following the same schedule. Participants will be followed weekly for up to twelve weeks, with wound measurements, imaging, pain assessments, and quality of life evaluations at each visit. Those who heal will have confirmation visits at two and four weeks post-closure. The study will measure wound area reduction, granulation tissue, pain levels, and quality of life changes. Safety monitoring will document adverse events and device-related issues throughout, with additional observation for crossover participants. The trial aims to provide clinical evidence supporting Miro3Ds role in enhancing wound healing in diabetic patients.

Researchers are evaluating the performance of two blood-based diagnostic tests designed to help detect cancer in individuals aged 45 and older who show symptoms, signs, or findings that suggest cancer. The study aims to assess these tests in people suspected of having cancer or those recently diagnosed but not yet treated. This observational study is sponsored by Harbinger Health and focuses on cancers originating from specific sites outlined in the study protocol. Participants will provide a blood sample of up to 40 mL collected in special tubes for analysis by the investigational diagnostic tests. Those with suspected cancer will undergo a standard diagnostic work-up to confirm if cancer is present, while those already diagnosed must be treatment-nave. The results of the diagnostic tests will not be shared with patients or doctors and will not influence clinical decisions. All testing and analyses are conducted in a blinded manner. During the study, participants will complete a blood draw and follow the usual diagnostic procedures as needed. Researchers will track clinical outcomes, diagnostic test performance, and cancer incidence over 18 months. The main measure is how well the two diagnostic tests identify cancer among participants showing relevant symptoms or signs. Safety and adherence will be monitored, but the study does not involve treatment. Total participation duration may vary depending on diagnostic and follow-up processes.

Researchers are evaluating the Miro3D Wound Matrix, a biologic wound dressing made from pig liver tissue, to help heal difficult wounds and ulcers in adults. This post-market, proof-of-concept study focuses on wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, and surgical wound openings. The study aims to understand how well Miro3D supports healing and improves quality of life when used alongside standard wound care in outpatient settings. Participants will receive weekly applications of Miro3D to their wounds for the first four weeks, alongside usual treatments like cleaning, dressing changes, offloading, and infection management. If the wound is not fully healed after four weeks, the Miro3D application frequency changes to every two weeks until healing occurs or up to twelve weeks total. The study includes a screening phase and a twelve-week treatment phase with no washout period. Throughout the study, participants will visit the clinic weekly for wound assessments, including measurements, photographs, and depth checks, and complete questionnaires about pain and quality of life. Healing progress is tracked by measuring wound size reduction and new tissue growth. Safety is closely monitored by tracking any adverse events. Participants finish the study when their wound heals or after twelve weeks and may then return to their regular doctor for follow-up care.