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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the Hexiris Microinvasive Scleral Trephine (MIST) system for treating Primary Open-Angle Glaucoma (POAG) in adults aged 40 years and older whose condition is not well controlled by topical drug therapies. This multicenter, open-label, non-randomized, single-arm study aims to reduce intraocular pressure (IOP) in the affected eye by creating a channel in the sclera. The study includes an initial safety phase with the first five patients treated in an operating room, followed by treatment of 20 patients in an outpatient clinic using a slit lamp in an aseptic environment. The treatment involves using the Hexiris MIST device, which includes a sclerectomy punch and injector assembly designed to remove a core of tissue to help lower IOP. Along with the device, patients receive a subconjunctival injection of mitomycin C at a concentration of 0.02-0.04% using sterile technique. The procedure is performed ab externo under topical anesthesia at the slit lamp. Postoperative care includes topical antibiotics and steroids. Participants will have follow-up visits the day after treatment, then at 1 week, and at 1, 2, 3, 6, 9, and 12 months afterward. During these visits, ophthalmologists will examine the treated eye and measure intraocular pressure. The primary outcome measured is the change in intraocular pressure from baseline to 6 months after treatment. The total follow-up period lasts for 12 months to monitor safety and performance of the device.

Age: 40Years +All GendersPhase Not Applicable
5 locations
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Actively Recruiting

Researchers are exploring the use of group medical visits (GMVs) to improve care for patients with dyslipidemia, a condition that contributes to most cases of cardiovascular diseases. Traditional physician interventions to encourage healthier lifestyles are effective but underused due to time constraints and other barriers. GMVs bring together groups of patients with similar conditions to receive assessments, education, and care, potentially improving access to primary care and patient outcomes. This study aims to evaluate how well GMVs can be implemented among patients with dyslipidemia in a primary healthcare clinic. The study will involve launching new GMV series every 3 to 6 months, each inviting about 20 patients diagnosed with dyslipidemia. During these sessions, patients will receive health assessments, education about their condition, prescriptions, lab test requests, and referrals as needed. The project will follow the RE-AIM framework to assess various aspects of the implementation, including patient participation, effectiveness, adoption by primary care providers, and maintenance over time. Participants will be monitored through questionnaires before and after GMVs to measure knowledge, confidence, behavior changes, and clinical outcomes like lipid profiles over 12 months. Data from the clinic's electronic medical records will also be used to compare clinical outcomes and track participation and service delivery. Physicians and clinic managers will be surveyed about their willingness to continue offering GMVs. Overall, the study aims to improve access to primary care and prevent cardiovascular diseases by supporting lifestyle changes in patients with dyslipidemia.

Age: 40Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the safety, feasibility, effectiveness, and lasting effects of non-invasive electrical vestibular stimulation (EVS) on balance and walking ability in healthy adults aged 18 to 100 years. This study focuses on improving balance and gait by stimulating the vestibular system, which helps maintain stability and coordination. The research also explores whether EVS-induced changes in vestibular function are linked to improvements in cognition and potential benefits for occasional headaches. The study involves 18 treatment sessions over 5 to 6 weeks where participants receive subthreshold wideband stochastic EVS through electrodes placed behind the ears and at the back of the neck. During each session, participants switch between sitting and standing on different surfaces with eyes open or closed while receiving stimulation. A sham comparator group receives no current during EVS treatment. Follow-up assessments occur at 3 weeks, 6 weeks, 3 months, and 6 months after treatment to evaluate lasting effects. Participants undergo various balance and gait tests using wearable sensors, smartphone app-based assessments, clinician-administered functional gait evaluations, and cognitive tests. Researchers measure outcomes such as postural sway, sensory integration, walking speed, step length, and trajectory before, during, and up to 6 months after treatment. Questionnaires assess headaches, cognition, dizziness, and physical activity. Safety and adverse events are monitored throughout the study.

Age: 18Years - 100YearsAll GendersPhase Not Applicable
4 locations
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