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Found 6 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating the safety and effectiveness of the ELIOS device compared to a competitor device in patients with open-angle glaucoma undergoing cataract surgery. The study focuses on adults aged 40 years and older who have mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma, or pigmentary glaucoma and a visually significant cataract suitable for phacoemulsification. The main goal is to see how well these treatments lower intraocular pressure (IOP) 12 months after surgery. Participants will undergo cataract surgery followed by treatment with either the ELIOS device or a competitor device as determined by the surgeon. Both treatments are delivered as procedures immediately after the cataract surgery. The study is designed as a prospective, multicenter, randomized clinical trial to compare these two approaches. During the study, participants will be monitored for effectiveness by measuring intraocular pressure at 12 months post-operation. Safety and other outcomes will also be evaluated throughout the study period. Participation involves follow-up visits and assessments to track eye pressure and overall eye health after treatment, ensuring thorough monitoring of results over time.
Actively Recruiting
Glaucoma is an irreversible optic nerve disease and the second leading cause of blindness worldwide. It can be treated with eye drops, laser, or surgery, but traditional surgery carries high risks of complications. The ELIOS laser system is a new micro-invasive glaucoma surgery (MIGS) device designed to reduce these risks by creating small microchannels in the eye to improve fluid drainage and lower eye pressure. This study aims to evaluate the safety and effectiveness of the ELIOS laser combined with cataract surgery in patients with glaucoma. The treatment involves using the ELIOS laser probe during cataract surgery to create about 10 microchannels through the trabecular meshwork and inner wall of Schlemm's canal. The laser uses a 308 nm wavelength to photoablate tissue, enhancing natural fluid outflow to reduce intraocular pressure (IOP). The procedure is usually completed in a few minutes and is performed as part of standard cataract surgery with no other changes to the process. Participants will have their intraocular pressure measured before surgery and at multiple follow-up visits on day 7, day 30, and months 3, 6, and 12 after surgery. The study collects data to better understand treatment effects and improve care for glaucoma patients. Safety and efficacy will be monitored throughout the one-year follow-up period.
Actively Recruiting
Pseudoexfoliative glaucoma is a form of glaucoma caused by pseudoexfoliative syndrome, often making cataract surgery more challenging and prone to complications. This research aims to compare the effectiveness of the Tran cannula, a single-use irrigation device designed to clean pseudoexfoliative material from the eye's drainage system, with increased standard irrigation in lowering eye pressure in patients with pseudoexfoliative glaucoma undergoing cataract surgery. Participants will undergo isolated cataract surgery followed by treatment of the trabecular meshwork using either the Tran cannula connected to the irrigation system or the classical aspiration cannula for augmented irrigation. The Tran cannula treatment occurs after phacoemulsification, intraocular implant insertion, and viscoelastic aspiration. The study evaluates these two procedures to assess their impact on intraocular pressure control. During the study, intraocular pressure will be measured at several time points: day 1, day 30, and months 3, 6, and 12 after surgery. The study focuses on patients with pseudoexfoliative glaucoma and cataracts, monitoring safety and efficacy throughout a year. Various examinations will be conducted to confirm eligibility and assess outcomes, including visual field tests, optical coherence tomography, and slit-lamp examinations.
Actively Recruiting
Researchers are investigating treatments for locally advanced anal squamous cell carcinoma, a rare but increasing cancer often linked to human papillomavirus (HPV). The study compares standard chemoradiotherapy, which combines radiation and chemotherapy with 5FU and mitomycin-C, to a new approach adding induction chemotherapy (modified DCF protocol) before the standard chemoradiotherapy. This randomized phase 3 trial aims to improve disease-related event-free survival and other outcomes such as overall survival, colostomy-free survival, treatment tolerability, response rate, and quality of life in patients with T3-T4 or N1 stage anal cancer without metastasis. Participants in the experimental group receive four cycles of induction chemotherapy (docetaxel, cisplatin, and 5-FU given every two weeks), followed by standard chemoradiotherapy consisting of 33 sessions of radiation over 6.5 weeks combined with mitomycin during weeks 1 and 5 and capecitabine taken on radiation days. The control group receives only the standard chemoradiotherapy. Radiation is delivered using intensity-modulated external irradiation (IMRT-SIB) targeting the pelvis and tumor area with specified doses. During the study, patients undergo follow-up visits starting 8 weeks after treatment, then every 4 months for two years, and every 6 months for a final year. Follow-up includes clinical exams and imaging tests such as CT and MRI. The study measures disease-related event-free survival at 2 years after treatment completion as the primary outcome. Participants must be adults aged 18 or older with measurable tumors on MRI and able to receive chemotherapy and radiotherapy, with additional health criteria assessed before enrollment.
Actively Recruiting
Researchers are evaluating a screening method for hepatitis B, hepatitis C, and AIDS viruses among drug users. The study aims to identify active infections of these viruses using a simple blood collection technique. It focuses on individuals with a history of intravenous or nasal drug use, including those receiving opiate substitution therapy. The study uses a Dried Blood Spot method for blood collection to screen participants for hepatitis B, hepatitis C, and AIDS viruses. This approach allows for easier sample collection and testing in this population. The intervention involves collecting blood samples on special filter paper to detect active infections. Participants are involved in one screening visit where their blood is collected using the Dried Blood Spot method. Researchers will assess the presence of active hepatitis B, hepatitis C, and AIDS infections on the first day. The study monitors the number of individuals with active infections as primary outcomes. The total participation time is focused on this initial screening event.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of fractionated stereotactic radiation therapy (FSRT) for treating patients with hemorrhagic brain metastases in a non-randomized Phase 2 trial. This study focuses on patients who have recent bleeding signals in their brain tumors and assesses how well FSRT controls tumor growth and bleeding complications. The trial is designed in two stages to carefully monitor outcomes in this specific population. Participants receive FSRT targeting each brain metastasis with a total dose of 30 Gy, divided into three fractions of 10 Gy each over a span of 7 days. This focused radiation therapy aims to treat lesions between 5 and 30 mm in size that show signs of recent bleeding. The treatment is planned and delivered after evaluation by a multidisciplinary committee to ensure eligibility and safety. During the study, patients undergo regular assessments including brain imaging to evaluate tumor response and check for new or increased bleeding up to 6 months after completing FSRT. Researchers also monitor safety by tracking hemorrhagic complications and tumor control using established criteria. Participants are followed closely to observe treatment effects and any side effects, with the total study duration including treatment and follow-up periods.