Aurangpur

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Neonatal encephalopathy causes significant death and lifelong disabilities in babies born in low and middle-income countries (LMICs). Traditional cooling therapy used in high-income countries is not easily applicable or safe in LMICs. Erythropoietin (Epo), a drug commonly used to treat anemia, shows promise as a neuroprotective treatment for neonatal encephalopathy when used alone. Early studies suggest Epo may reduce death or disability without serious side effects, but a large, definitive trial is needed to confirm its safety and effectiveness in LMICs. This trial is a phase III, multi-country, double-blind study comparing Erythropoietin injections to placebo in babies with moderate or severe neonatal encephalopathy. Babies will receive nine doses of Epo at 500 units per kilogram, starting within six hours of birth and continuing daily for eight days. Alongside the drug treatment, all babies will receive supportive neonatal intensive care, including temperature monitoring to maintain normal body temperature and clinical support as needed. Participants will be closely monitored throughout the study, with brain imaging performed between one to two weeks of age to assess neurological effects. The primary outcome measured is the number of babies who die or survive with moderate or severe disability at 18 to 22 months. The trial includes an 18-month recruitment period, 18-month follow-up, and five months for data analysis, with a pilot phase conducted before the main trial begins.

Researchers are evaluating the safety and effectiveness of LY4268989 when given together with mirikizumab compared to mirikizumab alone in adults with moderately to severely active ulcerative colitis (UC). This Phase 2 study focuses on adults aged 18 to 80 years who have had UC diagnosed for at least 3 months and have active symptoms confirmed by specific clinical scores and endoscopic evidence. The study aims to assess clinical remission using the Modified Mayo Score at 12 weeks. Participants will receive either LY4268989 by mouth combined with mirikizumab administered first intravenously and then by subcutaneous injection, or mirikizumab alone with a placebo pill. The entire study treatment period will last about 104 weeks, with up to 21 visits planned for monitoring. Treatment schedules and dosing are designed to compare the combination therapy to mirikizumab alone. During the study, participants will undergo regular assessments including clinical evaluations, endoscopy, and monitoring of symptoms and safety. Researchers will track the percentage of participants achieving clinical remission by week 12 using the Modified Mayo Score. Participants will be followed closely throughout the study duration, which totals approximately 118 weeks from start to finish, including treatment and follow-up visits.