Canton

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating a combination of disitamab vedotin and tucatinib for treating patients with advanced or metastatic breast cancer or gastric cancer that express the HER2 protein. These solid tumors, which arise in organs like the breast or stomach, are challenging to treat once they have spread or grown larger. The trial focuses on patients whose tumors have HER2, a marker that can make the cancer grow and spread faster. The study aims to assess the safety and effectiveness of this drug combination in these cancers. The study includes a dose escalation phase where disitamab vedotin is given intravenously while tucatinib is taken orally twice daily at 300 mg. After determining two appropriate dose levels, the study proceeds to a dose optimization phase to evaluate safety and efficacy in different patient groups based on HER2 expression and cancer type. Following this, an expansion phase will test the treatment in four specific cohorts, including HER2-low and HER2-positive breast and gastric cancers. Participants will have regular assessments including monitoring for side effects, laboratory tests, and scans to evaluate tumor response using RECIST criteria. Safety will be followed for up to approximately five years after the last treatment dose. Key outcomes measured include the number of participants experiencing dose-limiting toxicities, adverse events, laboratory abnormalities, and dose changes. The study also tracks the objective response rate to the treatment over about three years.

Researchers are evaluating the safety and effectiveness of Armour Thyroid compared to synthetic T4 treatment in adults with primary hypothyroidism who are currently stable on synthetic T4. The study focuses on assessing how well patients respond to dose conversion from synthetic T4 therapy to Armour Thyroid. This trial is conducted as a Phase 2/3 multicenter, double-blind, randomized, active-controlled study. Participants receive either Armour Thyroid in oral capsule or tablet form or synthetic T4 capsules. They must have been on a stable dose of synthetic T4 for at least 12 months before screening, with a dose of at least 25 mcg daily. The study compares both treatments over time to evaluate efficacy and safety in maintaining thyroid function. During the study, researchers monitor thyroid-stimulating hormone (TSH) levels to measure treatment response at week 55. They also track any adverse events related to the treatments for up to approximately 90 weeks. Participants undergo regular assessments to ensure safety and effectiveness throughout the study period.

Researchers are evaluating the effectiveness of cadisegliatin as an additional treatment alongside insulin in adults with Type 1 Diabetes Mellitus. This Phase 3 trial focuses on reducing the occurrence of serious hypoglycemia (low blood sugar) events over a 26-week treatment period. The study compares cadisegliatin combined with insulin to a placebo with insulin alone to see if the new treatment lowers the risk of dangerous drops in blood sugar levels. Participants receive either cadisegliatin at a dose of 800 mg once daily, 800 mg twice daily, or a placebo, all as adjunct therapy to their insulin regimen. The study treatment lasts for 26 weeks, during which participants continue their current insulin method, either continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI), without switching. Hybrid closed-loop insulin systems are not allowed. The trial is randomized, double-blind, and placebo-controlled to ensure reliable results. During the study, participants will be monitored for changes in the frequency of Level 2 or Level 3 hypoglycemia events. They must have used a continuous glucose monitoring device for at least three months before screening and maintain stable insulin therapy. Assessments include tracking hypoglycemic episodes, blood glucose levels, and HbA1c values. Safety evaluations and adherence to treatment will be closely observed throughout the 26-week period to understand the impact and safety of cadisegliatin as an adjunct therapy in this population.

Researchers are evaluating the effects of an experimental treatment called corneal crosslinking (CXL) for conditions where the cornea becomes thin, steep, and misshapen, leading to blurred vision. This Phase 3 trial focuses on participants aged 8 years and older with diagnoses such as keratoconus, ectasia after LASIK or PRK, pellucid marginal degeneration, progressive ectasia after previous CXL, or forme fruste keratoconus. The study aims to determine whether CXL can prevent or slow the progression of these corneal conditions and associated vision loss. The treatment involves applying riboflavin (vitamin B2 eye drops) to the eye followed by exposure to ultraviolet (UV-A) light. Participants are divided into two groups: one receives UV-A treatment for 18 minutes, and the other for 24 minutes. This procedure is designed to strengthen the cornea and potentially halt disease progression. Participants will attend up to 7 office visits over 6 months, undergoing various eye and vision tests. The main outcomes measured are changes in corneal curvature using Kmax via Pentacam imaging and changes in corrected distance visual acuity (CDVA) from enrollment through the 6-month treatment period. The study monitors participants closely to assess treatment effects and safety throughout this timeframe.

Researchers are evaluating an experimental treatment called corneal crosslinking (CXL) for people with conditions where the cornea becomes thin, steep, and misshapen, leading to blurred vision. This study focuses on participants aged 8 years or older with Down syndrome and related corneal diseases such as keratoconus, pellucid marginal degeneration, and forme fruste keratoconus. The main goal is to determine if CXL can prevent or slow the worsening of corneal shape and vision loss. The treatment involves applying riboflavin (Vitamin B2 eye drops) to the eye, followed by exposure to ultraviolet (UV-A) light for 20 minutes, aiming to strengthen the cornea. Participants will receive this treatment during the study, which is a phase 3 compassionate use trial. The study includes up to 7 office visits over 6 months for treatment and follow-up evaluations. During these visits, participants will undergo several eye and vision tests, including measuring corneal curvature with the Pentacam device and assessing vision improvement through corrected distance visual acuity. The study monitors changes from enrollment through the 6-month treatment period to evaluate the treatment's effects. Participants must comply with visit schedules and follow instructions to support the study's goals.

Researchers are evaluating whether breast conservation surgery combined with endocrine therapy can achieve a similar rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation surgery followed by breast radiation and endocrine therapy in patients with Stage I, hormone sensitive, HER2-negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial builds on the established role of radiation after lumpectomy, aiming to identify if radiation can be safely omitted in certain low-risk patients to reduce treatment burden and side effects. Participants receive either breast radiation plus endocrine therapy or endocrine therapy alone. Radiation therapy involves external beam radiation to the whole breast with or without a boost, partial breast irradiation, or accelerated partial breast irradiation, starting within 12 weeks after the last breast surgery. Endocrine therapy is given for a minimum of 5 years, with the specific drug choice and schedule determined by the treating physician. Endocrine therapy may begin before, during, or after radiation therapy, depending on the treatment group. Throughout the study, participants undergo regular assessments including imaging such as mammograms or MRI within six months before enrollment, and clinical evaluations to monitor tumor recurrence. The main outcome measured is the time to invasive or non-invasive ipsilateral breast tumor recurrence over five years. Safety, adherence to therapy, and recovery from surgery are also monitored. The total participation period includes at least five years to evaluate long-term recurrence rates.

Researchers are evaluating maridebart cafraglutide, a drug given as an addition to standard care, to see if it reduces heart-related problems and deaths better than a placebo in people with atherosclerotic cardiovascular disease who are overweight or obese. This phase 3 study focuses on cardiovascular events such as heart attacks, strokes, and deaths related to heart conditions, aiming to improve outcomes in this high-risk population. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study compares these two groups over a period of up to approximately 35 months, monitoring heart-related health events to assess the drug's impact. The placebo group will receive injections that look identical but contain no active drug, ensuring a double-blind study design. During the study, participants will be regularly evaluated for major cardiovascular events, including heart attack, stroke, heart failure, and death. Researchers will track the time until these events occur to measure the drug's effectiveness. Safety and health will be closely monitored throughout the study period, and participants will be followed for up to nearly three years to gather comprehensive data on cardiovascular outcomes and overall survival.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are investigating the effect of olpasiran compared to a placebo in reducing the risk of coronary heart disease death, heart attack, or urgent coronary revascularization in people at risk for their first major cardiovascular event who have elevated lipoprotein(a) levels. This Phase 3 study focuses on participants aged 50 years and older with multiple cardiovascular risk factors or evidence of atherosclerosis. The goal is to understand whether olpasiran can help prevent these serious heart-related events in this population. Participants will receive either olpasiran or a placebo through subcutaneous injections. The study is double-blind and randomized, meaning neither participants nor researchers will know who receives the active drug or placebo. The intervention period and follow-up will continue for up to approximately 6.2 years to monitor the occurrence of major cardiovascular events. During the study, participants will be closely monitored for outcomes including time to coronary heart disease death, myocardial infarction, or urgent coronary revascularization. Regular assessments will be performed to track cardiovascular health and safety. The long observation period aims to ensure thorough evaluation of olpasiran's impact on preventing first major cardiovascular events in people with elevated lipoprotein(a).