Bossier City

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 effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating whether the combination of vicadrostat BI 690517 and empagliflozin helps adults with heart failure who have symptoms and a left ventricular ejection fraction LVEF of 40% or more. This phase III study is designed to compare the effects of vicadrostatempagliflozin tablets versus placeboempagliflozin tablets on heart failure outcomes. The study aims to understand if this combined treatment improves health and reduces heart-related events. Participants are randomly assigned to one of two groups one group takes vicadrostat plus empagliflozin tablets once a day, and the other takes placebo plus empagliflozin tablets once a day. The study has no fixed duration and continues as long as participants benefit and tolerate the treatment. Throughout the study, participants visit their doctors regularly for health checks, and study staff may also contact them by phone to monitor well-being and any side effects. During the study, researchers monitor participants health through regular doctor visits and phone contacts. They collect data on heart-related events such as cardiovascular death, hospitalizations for heart failure, and urgent visits for heart failure over up to 42 months. Participants also answer questions about their symptoms and well-being. The study carefully tracks safety and treatment tolerance while gathering information to determine if the combined treatment helps people with heart failure.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

This trial evaluates inclisiran, a subcutaneous injection given twice yearly, for preventing major cardiovascular and limb events in patients who have undergone percutaneous coronary intervention PCI or peripheral endovascular intervention PVI. The study focuses on patients with atherosclerotic cardiovascular disease, including coronary artery disease and peripheral artery disease, aiming to assess inclisirans role alongside standard care in real-world settings. It is a randomized, double-blind, placebo-controlled, phase 4 study involving about 6,000 participants. Participants will receive either 300 mg of inclisiran or a matching placebo by subcutaneous injection on Day 1 within 14 days of their intervention, at Month 3, and then every 6 months thereafter. The study compares inclisiran to placebo while all participants continue their usual care prescribed by their physicians. The treatment duration varies with event accrual and follow-up but is expected to last approximately 4 years, with individual participants receiving treatment for up to about 45 months. Throughout the study, participants will be regularly monitored for major adverse cardiovascular events MACE and major adverse limb events MALE up to about 4 years from randomization. Additional assessments include tracking cardiovascular death, all-cause death, and venous thromboembolic events. The study includes safety monitoring and follow-up visits to evaluate the outcomes and adherence to the intervention and usual care during the entire study period.

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 an ECG-based artificial intelligence AI device designed to predict whether patients with interstitial lung disease ILD are at high risk for undiagnosed pulmonary hypertension PH. This multi-center, randomized study aims to determine if using this AI device can increase the rate of new PH diagnoses over a 6-month period compared to the current standard of care. Participants with ILD will undergo a 12-lead ECG, which the AI device will analyze to assess PH risk. Participants are randomly assigned to either the Device group, where investigators receive the AI device results, or the Control group, where results are not shared. Those in the Device group identified as high risk will receive additional tests including a transthoracic echocardiogram and right heart catheterization RHC. Participants not identified as high risk and all Control group participants will continue with standard care as determined by their physicians. Throughout the study, participants will be monitored over approximately 6 months to track new PH diagnoses. Assessments include ECGs, echocardiograms, RHC procedures if indicated, and ongoing clinical evaluations. Researchers will compare the proportion of new PH diagnoses between groups while ensuring participants receive appropriate care based on their risk and physician recommendations.

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.

This research aims to evaluate how well NeoThelium FT Amnion Skin Graft works and how safe it is for treating chronic pressure ulcers. The study will take place at multiple medical centers using an open-label design, meaning both patients and researchers will know which treatment is being given. It is a post-marketing study intended to gather information on the treatments effectiveness and to support insurance reimbursement decisions. Participants will receive standard care plus weekly applications of NeoThelium FT, which is a dehydrated wound covering made from donated human placental tissue with amnion and chorion layers. Treatment includes wound cleansing, sharp debridement, applying NeoThelium FT, dressing for moisture balance, and offloading to reduce pressure. Patients will continue follow-ups according to the original schedule. During the study, participants will be assessed for wound healing progress including complete wound closure within 1 to 16 weeks, percent area reduction, wound closure at 2 weeks, and the number of grafts used. Researchers will monitor safety and treatment adherence throughout the study period, which is expected to last up to 16 weeks. This helps understand the treatments impact on chronic pressure ulcers over time.

Researchers are evaluating whether TR987 0.1% gel combined with Standard of Care is more effective than Standard of Care alone for treating Venous Leg Ulcers VLUs. This Phase 3, outpatient, randomized, double-blind study focuses on participants with non-healing VLUs to assess the drugs efficacy and safety over 16 weeks. Participants are assigned to one of two groups one receiving TR987 0.1% gel plus Standard of Care, and the other receiving Standard of Care alone. The gel is applied topically twice weekly for the first four weeks, then weekly for the remaining 12 weeks. Standard of Care includes wound cleansing, dressings, and compression bandaging throughout the treatment period. During the study, participants will be regularly assessed for ulcer closure, pain levels, and changes in ulcer size at 12 and 16 weeks. The primary measure is the proportion of participants with complete ulcer closure by Week 16. Secondary outcomes include sustained closure at 3 months, pain reduction, and significant ulcer size reduction. Safety and tolerability are also monitored throughout the study period.