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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating a new treatment for Primary Open-Angle Glaucoma POAG using the Hexiris Microinvasive Scleral Trephine MIST system, a medical device designed to reduce intraocular pressure IOP in adults aged 40 years or older whose glaucoma is not controlled by topical medications. This multicenter, open-label, single-arm study focuses on safety and performance, treating only one eye per participant. The study includes an initial phase with five patients treated in an operating room and a subsequent phase with twenty patients treated in a clinic setting under a slit lamp. Participants will receive treatment with the Hexiris MIST device combined with a subconjunctival injection of mitomycin C. The first five treatments occur in the operating room, after which safety data will determine if the remaining patients are treated in the clinic. The procedure is performed under topical anesthesia using a sterile technique. Postoperative care involves topical antibiotics and steroids. Follow-up visits are scheduled at the day after treatment, then at 1 week, and 1, 2, 3, 6, 9, and 12 months. During follow-up, ophthalmologists will examine the treated eye and measure intraocular pressure along with other assessments such as bleb morphology, corneal thickness, and medication use. Researchers will monitor for safety events and device performance throughout the one-year study period. The primary outcome is the change in intraocular pressure from baseline to 6 months, with several secondary outcomes tracked up to 12 months post-treatment.
Actively Recruiting
Researchers are evaluating the use of group medical visits GMVs for patients with dyslipidemia, a key factor in most cardiovascular diseases. This study aims to implement GMVs in a primary healthcare clinic to improve lifestyle habits and access to care. GMVs involve group appointments that provide health assessments, education, prescriptions, and referrals, which may help reduce pressure on the healthcare system and improve patient outcomes. The study will follow the RE-AIM framework to assess how well GMVs are implemented and their effects on patients and healthcare providers. The intervention group will participate in a series of GMVs lasting 9 to 12 months, with eight sessions of 90 to 120 minutes each. These sessions will be delivered to groups of 8 to 12 patients by family physicians, dietitians, kinesiologists, and psychologists trained in GMVs. Sessions focus on lifestyle medicine related to dyslipidemia management, including goal setting, education, activities, and social interaction, with brief individual consultations if needed. The usual care group will continue with regular follow-up and may join GMVs after the study ends. Participants will be assessed through questionnaires before and after GMVs to measure changes in knowledge, self-efficacy, behavior intentions, and actual behaviors. Clinical outcomes such as lipid profiles and hospitalizations will be compared between groups using medical records. Researchers will also evaluate how many patients participate, representativeness, healthcare provider attitudes, and the quality and maintenance of GMVs. The study is expected to last several years, with ongoing monitoring of service delivery and willingness to continue GMVs.
Actively Recruiting
Healthy Volunteer
This research aims to evaluate the safety, feasibility, effectiveness, and lasting impact of non-invasive electrical vestibular stimulation EVS on balance and walking ability in healthy adults aged 18 to 100 years. It focuses on how EVS influences balance and gait by measuring performance before, during, and after single and repeated sessions at multiple partner sites. The study addresses age-related balance decline, known as presbystasis, which increases fall risk and affects independence, especially in older adults, and explores EVS as a potential non-invasive solution to restore vestibular function and possibly improve cognitive function and headaches. Participants will receive either active treatment with sub-threshold wideband stochastic EVS swsEVS or a sham treatment with no stimulation, in a randomized, single-blind design. The study involves 18 testing sessions over 5 to 6 weeks, where participants undergo EVS while alternating sitting and standing positions with eyes open or closed. Several assessments will be conducted including accelerometer-based gait and balance tests using a smartphone app, clinician-administered Functional Gait Assessments, static and dynamic balance tests, cognitive tests, and questionnaires about headaches and dizziness. Participants will complete balance and gait tests before and after each EVS session, with follow-up visits at 3 weeks, 6 weeks, 3 months, and 6 months post-treatment to evaluate lasting effects. Cognitive assessments and headache questionnaires are done during the first and last treatment sessions. Safety and tolerability are monitored throughout. The main outcomes measured include various balance and gait parameters such as postural sway, gait velocity, cadence, step length, and step trajectory, along with cognitive performance tests, to assess the impact of the stimulation over time.