Wardha

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

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.

This research aims to evaluate the neurodevelopmental outcomes at 22 to 26 months of age in term or late preterm infants who were non-vigorous at birth. The study compares infants who received umbilical cord milking (UCM) with those who underwent early cord clamping (ECC) to assess differences in survival and neurodevelopmental impairment. It builds on the original CORDMILK trial and focuses on infants affected by conditions like hypoxic-ischemic encephalopathy and birth asphyxia. The intervention being studied is umbilical cord milking, where the umbilical cord is grasped and blood is pushed toward the infant four times before clamping, completing the procedure in 10-15 seconds. This method is compared to early cord clamping. The study follows infants from the original CORDMILK trial, focusing on their outcomes at 22 to 26 months of age. Participants will be assessed using standardized neurological and developmental tools to measure survival and neurodevelopmental outcomes at 22 to 26 months. The study involves follow-up evaluations to monitor the infants' progress and development over this period. No specific exclusion criteria are listed, and the study includes infants enrolled in the original trial who were non-vigorous at birth.

Premature birth is a leading cause of death in children under five years old, with around 15 million premature infants born worldwide annually, including many in India. This trial investigates whether umbilical cord milking (UCM) compared to early cord clamping can reduce in-hospital mortality in non-vigorous preterm infants born between 30 and 34 weeks of gestation. The study aims to provide evidence to support changes in guidelines for preterm infant care during delivery. Participants will be randomly assigned to either early cord clamping or umbilical cord milking, where the cord is squeezed four times to push blood toward the infant before clamping. This simple procedure takes 1 to 15 seconds and delivers placental blood transfusion. The trial is conducted across multiple centers with approximately 800 preterm infants enrolled. During the study, infants will be monitored from birth until hospital discharge or death, up to 12 weeks, to assess in-hospital mortality. Researchers will observe outcomes related to the different cord management techniques to determine their impact on survival rates. This low-cost intervention could offer a valuable option for improving outcomes in preterm infants requiring immediate resuscitation.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of oral AUR112 in patients with relapsed advanced lymphomas. This Phase 1, open-label, dose escalation study aims to assess the tolerability of AUR112 and determine the doses suitable for future trials. The study involves patients with relapsed Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Hodgkin disease who have exhausted other effective therapies locally. Participants will receive AUR112 once daily, with dose escalation following a classic 3+3 design. Dose escalation continues until safety limits are reached or pharmacokinetic and pharmacodynamic data indicate a biologically active dose. The study monitors dose limiting toxicities and treatment-related adverse events, alongside detailed pharmacokinetic measurements at specified time points. During the study, participants will be closely monitored through clinical assessments and laboratory tests to evaluate safety and drug behavior in the body. Key outcomes include dose limiting toxicities within the first treatment cycle, adverse events graded by standard criteria, and pharmacokinetic parameters such as maximum concentration and half-life. The study also evaluates safety under fasting and fed conditions over a 28-day treatment cycle.

Researchers are evaluating lumateperone as an additional treatment for adults aged 18 to 65 with major depressive disorder (MDD) who have not responded adequately to current antidepressant therapy. This phase 3, multicenter, randomized, double-blind, placebo-controlled study aims to assess the effectiveness and safety of lumateperone in patients diagnosed according to the DSM-5 criteria, including those with psychotic features. Participants must have moderate to severe depression and an ongoing major depressive episode lasting between 12 weeks and 18 months. Participants will be randomly assigned to receive either lumateperone 42 mg capsules or matching placebo capsules once daily during a six-week double-blind treatment period. Before treatment, there is a screening period of up to two weeks to confirm eligibility. After the treatment phase, there is a one-week safety follow-up visit to monitor participants after completing the study medication. Throughout the study, patients will be assessed using depression rating scales including the Montgomery-Asberg Depression Rating Scale (MADRS). Other evaluations include psychiatric interviews, symptom questionnaires, and safety monitoring for suicidal thoughts or behaviors. The study tracks changes in depression severity and safety outcomes from screening through treatment and follow-up, totaling approximately nine weeks of participation.