Canton

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 in adults with primary hypothyroidism who have been stable on synthetic T4 treatment. The study will also assess how well patients tolerate switching from synthetic T4 to Armour Thyroid. This trial is a Phase 23, randomized, double-blind study sponsored by AbbVie to compare these two thyroid hormone replacement therapies. Participants will be randomly assigned to receive either Armour Thyroid or to alternate between Armour Thyroid and synthetic T4 for up to 81 weeks. The treatments are oral capsules or tablets taken daily, with doses carefully converted from their stable synthetic T4 dose. The study includes a dose-conversion period where dosage adjustments may be made to maintain appropriate thyroid hormone levels. During the study, participants will have regular blood tests to measure thyroid-stimulating hormone TSH levels, including at week 55 to see who achieves a target TSH response. Researchers will also monitor for any adverse events throughout the study, which lasts up to about 90 weeks. Dose adjustments and safety data will be tracked closely to understand treatment effects and tolerability over time.

Researchers are conducting a multicenter, randomized, double-blind Phase 2 study to evaluate the pharmacodynamics, safety, and tolerability of a combination of QCZ484 and inclisiran compared to QCZ484 alone, inclisiran alone, and placebo in adults with hypertension and hypercholesterolemia. The study focuses on understanding how these treatments affect certain blood markers and blood pressure in this population. Participants receive a single dose of either the combination of QCZ484 and inclisiran, QCZ484 alone, inclisiran alone, or placebo on Day 1. The study lasts up to 12 months and includes a screening period with two visits to confirm eligibility, followed by the treatment administration at the baselinerandomization visit. After treatment, participants enter a safety follow-up phase, with an option to join an open-label extension study instead of the follow-up. During the study, participants undergo various assessments including measurements of PCSK9 and AGT levels at baseline and Month 3, blood pressure and LDL cholesterol levels at baseline, Month 3, and Month 6, along with monitoring for treatment-emergent adverse events and changes in laboratory tests and vital signs for up to 12 months. These evaluations help researchers understand the effects and safety of the treatments over time.

This clinical trial studies the effects of a new treatment called corneal crosslinking CXL for eye conditions where the cornea becomes thin, steep, and misshapen, causing blurry vision. The trial focuses on patients aged 8 years and older diagnosed with keratoconus, ectasia after LASIK or PRK, pellucid marginal degeneration, progressive ectasia after previous CXL, or forme fruste keratoconus. The main goal is to find out if CXL can slow or stop the progression of these corneal diseases and prevent vision loss. Participants will receive CXL treatment where riboflavin Vitamin B2 eye drops is applied to the eye, followed by exposure to ultraviolet A UVA light. Two groups will be compared one group receives UVA treatment for 18 minutes and the other for 24 minutes, both with 15-second off-on cycling. The treatment aims to strengthen the cornea and stop disease progression. During the 6-month study, participants will attend up to 7 office visits for eye and vision tests. Researchers will measure corneal curvature using Kmax with the Pentacam and corrected distance visual acuity CDVA to evaluate effectiveness. Secondary measures include uncorrected visual acuity UCVA and possibly changes in higher order aberrations HOA and coma if wavefront testing is done. Safety and treatment effects will be monitored throughout the study period.

Researchers are studying an experimental treatment called corneal crosslinking CXL for people with Down syndrome who have corneal conditions where the cornea thins, steepens, and becomes misshapen, causing blurred vision. This treatment aims to strengthen the cornea and possibly prevent or slow vision loss. The study focuses on whether CXL can stop or slow this progression. Participants must be at least 8 years old and diagnosed with Down syndrome or similar cognitive or developmental conditions. The treatment involves applying riboflavin Vitamin B2 eye drops to the eye, followed by exposure to ultraviolet A UVA light for 20 minutes. This process is called Epi-ON corneal cross-linking and is performed during the study. Participants will receive this treatment and be monitored over a 6-month period. Participants will attend up to 7 in-office visits during the 6 months, where various eye and vision tests will be conducted. Researchers will measure corneal curvature and vision changes using tools like the Pentacam and visual acuity tests. They will also assess vision improvements with additional measures such as high order aberrations and coma. The study includes follow-up visits to track treatment effects and safety over time.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are studying maridebart cafraglutide to evaluate its effect on reducing cardiovascular problems and death in people with atherosclerotic cardiovascular disease who are also overweight or obese. This Phase 3 trial compares maridebart cafraglutide to a placebo, both given alongside standard care, to see if maridebart cafraglutide works better in lowering heart-related risks. Participants will receive either maridebart cafraglutide or a placebo, both administered by subcutaneous injection. The study lasts for up to approximately 35 months, during which researchers monitor several heart and health outcomes. These include heart attacks, strokes, death rates, hospitalizations, blood pressure, body measurements, blood sugar control, cholesterol levels, kidney function, and inflammatory markers. During the trial, participants will have regular assessments including physical exams, blood tests, and monitoring of heart events. Researchers track the time to first major heart-related events and changes in health markers over the study period. Safety is also monitored by recording any adverse events. The total participation time can last nearly three years, allowing careful observation of the effects of the study drug compared to placebo.

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 olpasiran, compared to a placebo, to see how it affects the risk of coronary heart disease death, heart attacks, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have high levels of lipoproteina. This Phase 3 study focuses on participants aged 50 to 105 years with multiple cardiovascular risk factors or evidence of atherosclerosis. Participants will be randomly assigned to receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind, so neither participants nor researchers know who receives the active drug or placebo. Treatments and evaluations will continue for up to approximately 6.2 years. Throughout the study, participants will be monitored for heart-related events such as heart attacks, cardiovascular death, strokes, and coronary revascularizations. Researchers will also measure changes in lipoproteina levels at baseline and at Week 48, along with tracking adverse events. The total participation duration can extend up to about 6.2 years, with ongoing assessments to evaluate the treatments effect over time.

This research aims to evaluate the effects of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in adults aged 40 and older who have type 2 diabetes, established cardiovascular disease, a history of hypertension with a systolic blood pressure of at least 130 mmHg, and at least one additional risk factor for heart failure. The study is a phase III, randomized, placebo-controlled trial focusing on preventing heart failure events and cardiovascular death. Participants will be randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those starting the baxdrostatdapagliflozin treatment may begin with a lower baxdrostat dose that can be increased if certain criteria are met. A run-in period with dapagliflozin alone for 4 to 6 weeks may occur for those not previously treated or treated less than 4 weeks with SGLT2 inhibitors. Treatment visits will occur at about 2, 4, 8, 16, and 34 weeks after randomization, then every 4 months until study closure. Participants will undergo screening for eligibility within a 14-day period, with an optional pre-screening phase that does not require site visits or consent. During the study, regular assessments including monitoring for heart failure events and cardiovascular outcomes will be conducted. If participants stop the blinded treatment early, they may continue with open-label dapagliflozin unless specific discontinuation criteria apply. The study will continue until a predetermined number of cardiovascular events occur, with ongoing data collection and visits according to protocol.