Nellore

Researchers are evaluating the efficacy and safety of benralizumab, given as a subcutaneous injection, in children and adolescents aged 6 to under 18 years who have severe eosinophilic asthma. These patients have a history of asthma exacerbations and uncontrolled symptoms despite treatment with high-dose inhaled corticosteroids plus at least one other controller medication. This Phase III study aims to compare benralizumab to placebo in reducing the time to the first asthma exacerbation. The study includes a screening period lasting from 4 to 12 weeks to confirm eligibility. After screening, patients are randomly assigned in a 1:1 ratio to receive either benralizumab or placebo via subcutaneous injections during a double-blind treatment period lasting a minimum of 16 weeks. This period continues until the patient experiences an asthma exacerbation or a set number of events occur. Patients who exacerbate can enter an open-label extension where all receive benralizumab for at least 48 weeks. An end-of-treatment visit occurs 8 weeks after the last dose in the extension phase. Participants will be monitored through visits and assessments including confirmation of severe eosinophilic asthma, asthma control questionnaires, and symptom diaries. Researchers will measure the time to first asthma exacerbation as the primary outcome. Medication adherence is tracked during screening, and safety is monitored throughout both the double-blind and extension periods. Total participation may span over a year, considering screening, treatment, extension, and follow-up visits.

Researchers are evaluating the efficacy and safety of verekitug (UPB-101) in adults with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), a long-term inflammatory lung condition. This global, multicenter Phase 2b study aims to understand how well verekitug works compared to a placebo, alongside participants' usual COPD medications. Participants must have a confirmed COPD diagnosis and meet specific lung function and symptom criteria to join the study. Participants will be randomly assigned to receive one of two doses of verekitug or a matching placebo, in addition to their regular COPD background treatments. The study includes a screening period of about 4 weeks, followed by treatment lasting between 60 and 108 weeks. After treatment, there is a 16-week follow-up period to monitor participants after their last dose. Throughout the study, participants will undergo various assessments including lung function tests and symptom evaluations. Researchers will track the annual rate of moderate or severe COPD flare-ups from the start of treatment through week 108. Safety and tolerability will be closely monitored during the treatment and follow-up periods to ensure participants' well-being over the course of the trial.

Researchers are evaluating the safety and effectiveness of centhaquine citrate (LYFAQUIN193), a new drug designed to treat hypovolemic shock, which is a serious condition caused by severe blood or fluid loss. This phase IV, open-label, multi-center study involves adult patients aged 18 years or older who are experiencing hypovolemic shock with low blood pressure and elevated blood lactate levels. Centhaquine has shown promising results in animal models by improving blood pressure, cardiac output, and reducing mortality through its action on specific adrenergic receptors. Participants will receive centhaquine alongside standard shock treatments such as fluid resuscitation, vasopressors, and endotracheal intubation. The drug will be given intravenously at a dose of 0.01 mg/kg in 100 mL of normal saline over one hour. If blood pressure remains low, an additional dose may be given after 4 hours, with a maximum of three doses within 24 hours. Centhaquine administration can continue for up to two days after enrollment, with close monitoring throughout their hospital stay. During the study, patients will be monitored until discharge or for up to seven days from enrollment. Researchers will assess safety by tracking adverse and serious adverse events, as well as efficacy by measuring blood pressure, lactate levels, base deficit, and survival rates. Statistical analyses will compare patient outcomes, and the results will be presented with detailed data summaries to evaluate the drug's safety and benefits when added to standard care for hypovolemic shock.

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 conducting a Phase II/Phase III study to evaluate the safety and effectiveness of Ramatroban 75 mg tablets compared to a placebo in patients hospitalized with pneumonia caused by SARS-CoV-2 infection. The study aims to assess both safety and efficacy of Ramatroban in combination with standard care versus placebo with standard care. Additionally, the study will explore the impact of Ramatroban on preventing or reducing long COVID symptoms by examining certain lipid mediators in recovered patients. Participants will be randomly assigned to one of two groups: one group will receive Ramatroban 75 mg tablets twice daily along with standard care, while the other group will receive a matching placebo twice daily with standard care. The treatment period lasts for 28 days, and participants will be monitored over a total study period of about 365 days. The study design is randomized, double-blind, placebo-controlled, and parallel in multiple centers. During the study, participants will be closely monitored for safety through the rate of serious adverse events and for efficacy by measuring time to clinical recovery up to day 15. Assessments include laboratory tests confirming SARS-CoV-2 infection, oxygen saturation levels, and radiological evidence of pneumonia. Follow-up evaluations will continue up to one year to study long-term outcomes including long COVID. Participants are expected to comply with study procedures and contraception requirements if applicable throughout the study duration.