Kendall

Researchers are investigating the potential benefits of GB-0895 as an additional treatment for adolescents and adults with severe asthma that remains uncontrolled despite using inhaled corticosteroids and other usual asthma treatments. This global, multicenter Phase 3 trial compares the effects of GB-0895 to a placebo in patients aged 12 to 80 years with severe uncontrolled asthma. The study also includes an optional open-label extension phase to further assess long-term effects and safety. Participants are randomly assigned to receive either GB-0895 or a placebo through subcutaneous injections every 6 months over a 52-week treatment period. Before treatment, there is a screening and run-in phase lasting about 6 weeks. After the 52 weeks of treatment, participants enter a follow-up period lasting up to 38 weeks or may choose to join the optional open-label extension lasting up to 90 weeks, during which they continue receiving GB-0895 at specified intervals. Throughout the study, participants attend visits every 1 to 2 months after the first month to monitor their health and asthma control. Researchers evaluate the annualized asthma exacerbation rate as the main outcome. Safety assessments include physical exams, vital signs, lab tests, and careful monitoring for adverse effects. The study aims to enroll about 786 participants globally to thoroughly assess the safety and effectiveness of GB-0895 as an add-on therapy for severe uncontrolled asthma.

Researchers are evaluating real-world treatment patterns, effectiveness, and side effects of xanomeline and trospium chloride (KarXT) in adults diagnosed with schizophrenia in the United States. This study aims to describe how patients respond to KarXT treatment and the related adverse events as observed in routine clinical care. Participants receive xanomeline and trospium chloride (KarXT) following the product label instructions. They may either be starting KarXT treatment within 16 weeks with plans to stop previous antipsychotics or already on a stable antipsychotic regimen and switching to KarXT under their clinician's guidance. Other psychiatric medications like antidepressants or mood stabilizers can be continued at stable doses during the study. During the study, participants' treatment adjustments and switches are tracked from baseline up to 20 weeks. Researchers monitor treatment effectiveness and safety through regular clinical follow-up, recording any changes, side effects, or adverse events. The study relies on the treating clinician’s judgment to assess treatment progress and participant safety throughout the observation period.

Researchers are evaluating the effects of two inhalers, budesonide/albuterol metered-dose inhaler (BDA MDI) and albuterol sulfate metered-dose inhaler (AS MDI), both taken as needed, on reducing severe asthma attacks in adolescents aged 12 to under 18 years who have a clinical diagnosis of asthma and have experienced at least one severe asthma exacerbation in the past year. This is a Phase IIIb randomized, double-blind, multicenter study lasting 52 weeks with a safety follow-up period after treatment. Participants will be randomly assigned to receive either BDA MDI 160/180 micrograms (two puffs of 80/90 micrograms) or AS MDI 180 micrograms (two puffs of 90 micrograms) as needed, alongside their usual asthma maintenance therapy, for 52 weeks. The study includes a 7 to 28-day screening period before treatment and a safety follow-up visit 7 to 14 days after the end of treatment. Additionally, a pharmacokinetic sub-study involves a single dose of open-label BDA MDI administered after the safety follow-up. During the study, participants will be monitored for the annual rate of severe asthma exacerbations from randomization to week 52. Assessments include evaluating inhaler technique, peak expiratory flow measurements, and adherence to contraception methods for participants of childbearing potential. Safety will be monitored throughout the treatment and follow-up periods. The total study duration includes screening, 52 weeks of treatment, and safety follow-up.

Researchers are investigating treatments for patients who have had a deep brain bleed, a type of stroke called intracerebral hemorrhage. The study compares early minimally invasive surgery to remove the blood clot with routine medical care. The goal is to see if this less invasive surgery can improve recovery and outcomes compared to standard care, which sometimes includes surgery to relieve brain pressure. This trial is known as the REACH trial. Participants are randomly assigned to one of two groups. One group receives minimally invasive surgery performed by a specially trained neurosurgeon within 24 hours of symptom onset, aiming for less than 8 hours. The other group receives standard medical care following guidelines, including intensive care monitoring, blood pressure control, and treatments to prevent further bleeding or stroke complications. Both approaches follow detailed manuals to ensure consistent care. During the study, participants are closely monitored and assessed using the modified Rankin Scale 180 days after randomization to measure recovery and disability levels. Researchers collect data on patient outcomes to understand which treatment provides better results. The study involves detailed imaging, clinical assessments, and ongoing care to track progress over time.