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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC as a treatment for psychosis linked to Alzheimer's disease. This Phase 3 clinical trial focuses on people aged 55 to 90 years diagnosed with Alzheimer's disease and experiencing psychotic symptoms, such as hallucinations and delusions. The study aims to understand how this treatment affects these neuropsychiatric symptoms over approximately 14 weeks. Participants will receive either KarXT plus KarX-EC or a matching placebo at specified doses on designated days. The study is double-blind and placebo-controlled, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial. This parallel group design helps compare the treatment's impact against no active drug. During the study, participants will be monitored for changes in hallucinations and delusions using the Neuropsychiatric Inventory-Clinician scale up to about week 14. They will also undergo brain imaging review from recent MRI or CT scans to confirm eligibility and rule out other causes of dementia. Safety and efficacy will be carefully assessed throughout the trial period, ensuring close observation of any side effects or improvements.
Actively Recruiting
Researchers are evaluating the optimal duration of antibiotic treatment for adults with complicated intra-abdominal infections (cIAI). This Phase 3 trial aims to compare a fixed extended duration of 28 days of antibiotics to the current standard care durations, which typically range from 7 to 18 days. The study will assess clinical outcomes, quality of life, and cost effectiveness over a 180-day follow-up period to determine which approach may better reduce treatment failure and improve patient care while considering antimicrobial resistance concerns. Participants will be randomly assigned to one of two groups: the standard care group, where antibiotic type and duration are determined by their clinician, or the fixed extended-duration group, which receives antibiotics for a set 28-day period. The study includes a total of 1166 adult patients recruited from intensive care units and hospital wards across approximately 30 NHS trust hospitals. The treatment period is followed by monitoring up to 180 days after randomization. During the study, patients or their personal consultees will complete quality of life questionnaires at baseline and at 30, 60, and 180 days post-randomization. They will also provide information about antibiotic use and healthcare resource utilization. Researchers will collect hospital records on admissions, relapses, and further infections. The main outcome measured is treatment failure within 180 days of randomization, with safety and effectiveness assessed throughout the follow-up period.
Actively Recruiting
Researchers are evaluating a phase III randomized clinical trial for patients with unilateral malignant pleural mesothelioma (MPM). The study aims to compare progression-free survival and overall survival between two approaches: proton beam therapy and standard surveillance. Patients will be stratified based on tumor histology, treatment center, tumor side, and time since diagnosis to assess these outcomes. Participants in the experimental group will receive proton beam therapy targeted at the hemithorax, delivering a total dose of 50Gy in 25 daily fractions over five weeks, with an additional boost to 60Gy for visible tumors. The control group will undergo standard care surveillance without immediate treatment, with immunotherapy or chemotherapy offered if disease progression occurs. Both groups will be followed for two years from randomization. During the study, patients will have regular follow-up visits at their local trial sites for assessments including safety, tolerability, quality of life questionnaires, and disease monitoring. The main outcomes measured are progression-free survival and overall survival up to two years. The study plans to recruit 148 patients across 20 UK centers, with additional interim analyses to evaluate treatment efficacy and safety throughout the trial period.