Odesa

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who have agitation related to Alzheimer's Disease. This phase 3 study aims to better understand how these treatments impact agitation symptoms in this population by comparing them to a placebo group. Participants must have a confirmed Alzheimer's diagnosis and meet specific criteria for agitation severity to join the study. Participants will receive either the Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, or a placebo, each given at specified doses on designated days. The study is randomized, double-blind, and placebo-controlled to ensure reliable comparison of treatment effects. The treatment period lasts through Week 14, during which dosing schedules are closely followed. Throughout the study, participants will be regularly assessed using the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) to measure changes in agitation levels from baseline to Week 14. Caregivers will provide reports on participant status and help ensure medication compliance. Safety and symptom changes will be carefully monitored to evaluate the treatments' effects during this period.

Researchers are evaluating the safety and effectiveness of adding KarXT (Xanomeline/Trospium Chloride) to standard treatment for mania in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind study focuses on individuals experiencing acute manic episodes, with or without mixed features, who are already taking lithium, valproate, or lamotrigine. The study aims to measure changes in mania symptoms using the Young Mania Rating Scale at Week 5. Participants will be randomly assigned to receive either KarXT or a placebo alongside their stable dose of lithium, valproate, or lamotrigine. The doses of these medications are specified and given on set days during the study. Only those with stable mood stabilizer doses for at least two weeks prior to screening, and valproate treatment for at least seven months, are eligible. The treatment period lasts for 5 weeks. During the study, participants will be closely monitored through psychiatric evaluations and clinical assessments. Researchers will assess mania severity, safety, and any side effects. The main outcome is the change from baseline in the Young Mania Rating Scale score at Week 5. Participants’ physical health, including liver function and risk of urinary or gastrointestinal issues, will also be monitored to ensure safety throughout the trial.

Researchers are evaluating the safety and effectiveness of KarXT compared to a placebo for treating adults with Bipolar-I disorder experiencing an acute episode of mania or mania with mixed features. This Phase 3 study involves participants who require hospitalization due to their manic episode and aims to assess symptom improvement over a short-term inpatient period. The study lasts up to seven weeks, including screening, treatment, and safety follow-up. Participants will be randomly assigned to receive either KarXT or a placebo in specified doses during a three-week inpatient treatment period. The study is conducted in a double-blind manner, meaning neither the participants nor the researchers know who receives the active drug or placebo. The focus is on the change in mania symptoms measured by the Young Mania Rating Scale during the three weeks. Throughout the study, participants will be closely monitored with psychiatric evaluations and rating scales, including the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Safety assessments continue during the follow-up period. The total participation time, from screening through treatment and safety monitoring, will not exceed seven weeks.

This trial focuses on people aged 55 to 90 who have agitation related to Alzheimer's Disease and previously finished one of two earlier studies. It aims to assess the long-term safety and effectiveness of a combination treatment using xanomeline tartrate/trospium chloride immediate release capsules (KarXT) and xanomeline enteric capsules (KarX-EC) in these participants. The study is a Phase 3 open-label extension, meaning all participants receive the treatment while researchers observe effects over time. Participants receive specified doses of KarXT and KarX-EC on set days as part of the treatment regimen. The study follows those who completed the earlier parent studies CN012-0023 or CN012-0024, continuing to monitor their response to the combined medication over an extended period. Throughout the study, researchers evaluate the number of participants who experience any treatment-emergent adverse events up to about 30 weeks. Caregiver involvement is required, with at least one caregiver having regular contact of about 10 hours per week or more. Safety and tolerability are closely monitored to understand the long-term impact of the treatment in managing agitation associated with Alzheimer's Disease.

Researchers are evaluating the safety, effectiveness, and tolerability of sodium zirconium cyclosilicate (SZC) for treating high potassium levels (hyperkalaemia) in children under 18 years old. This Phase 3, open-label international study will enroll about 140 children across roughly 46 sites in Europe, North America, and other locations. Enrollment begins with children aged 6 to under 12 years and 12 to under 18 years, with plans to include younger age groups based on data review. The study aims to assess whether SZC can help children achieve and maintain normal potassium levels safely. Treatment involves three phases: a Correction Phase (CP) where all participants receive SZC three times daily for up to 3 days to reach normal potassium levels; a 28-day Maintenance Phase (MP) where SZC is taken once daily with dose adjustments to keep potassium normal; and an optional Long-Term Maintenance Phase (LTMP) for continued treatment with monthly visits. Younger children receive doses based on body weight equivalent to adult dosing, with dose levels adjusted after safety reviews by an independent committee. During the study, participants will have blood tests, ECGs, and other assessments to monitor potassium levels, electrolyte balance, and safety. Researchers will evaluate the ability to achieve normokalaemia during the CP and maintain it during the MP and LTMP. The study lasts about 28 weeks, including safety follow-up, and will also assess SZC's acceptability and palatability for children.

Researchers are evaluating the use of an artificial intelligence (AI)-based software platform called Retina-AI to detect diabetic retinopathy (DR), a diabetes-related eye condition. The study focuses on assessing how well this AI software can identify DR using images of the eye's retina. Participants include adults diagnosed with diabetes, aiming to improve early detection of this eye disease. The study involves taking fundus photographs of participants' eyes using a non-mydriatic fundus camera, which captures images without the need to dilate the pupils. Two images per eye are taken following the Retina-AI CheckEye imaging protocol: one centered on the optic disc and one on the fovea. These images are then uploaded into the AI system, where a neural network processes them to identify signs of diabetic retinopathy. Participants will have their eye images analyzed by the AI software to measure its accuracy in detecting diabetic retinopathy at the start of the study. The study includes gathering informed consent and ensuring participants meet the age and diabetes diagnosis criteria. Safety and accuracy are monitored through these imaging and analysis procedures, with total participation spanning the time needed for image capture and AI processing.

Researchers are studying inherited eye diseases, including Mendelian and complex age-related conditions, in families from diverse nationalities and ethnic backgrounds. The goal is to identify the genes responsible for these inherited eye diseases and understand how genetic mutations affect eye health. Diseases studied include cataracts, corneal dystrophies, retinal degenerations, myopia, and glaucoma. Participants will have one visit lasting 3 to 4 hours that involves a medical and family history review, an eye exam with pupil dilation, electroretinography where electrodes and contact lenses are used to test eye responses to flashing lights, and collection of blood and saliva samples for genetic testing. Genetic testing will analyze DNA from blood or saliva to identify mutations linked to inherited eye diseases. Researchers may discuss genetic test results with participants. During the study, participants will be assessed through detailed eye exams and blood tests. Researchers will analyze genetic data using various techniques to find gene mutations and their effects. The study aims to enroll up to 5,000 participants and family members. Participation involves cooperation with examinations and blood draws, and the study will monitor clinical and genetic features of inherited and age-related visual disorders throughout the study period.

Researchers are evaluating the efficacy and safety of cariprazine in treating adolescents aged 13 to 17 years with schizophrenia. This Phase 3 study compares cariprazine to a placebo to understand its effects on this population. Participants must have a confirmed diagnosis of schizophrenia based on DSM-5 criteria and meet specific symptom severity requirements. Participants receive either cariprazine or matching placebo capsules once daily by mouth for 6 weeks in a randomized, double-blind, parallel-group design. The study is conducted across multiple international centers to ensure diverse participation and data collection. Throughout the 6-week study, researchers assess changes in schizophrenia symptoms using the PANSS total score from baseline to Week 6. Safety and tolerability are also monitored closely. Participants will undergo clinical evaluations and symptom scoring to track progress and response to treatment during the study period.

The EU-ROP registry is a European-wide, multicenter, non-interventional observational study focused on infants born prematurely who develop retinopathy of prematurity (ROP) that requires treatment. This registry aims to collect clinical routine data without performing any study-specific tests or interventions. Its purpose is to gather extensive information on the clinical features, disease progression, treatment approaches, follow-up, and long-term outcomes of severe ROP across different European countries. Infants who develop treatment-requiring ROP and receive any kind of treatment at participating centers are included in the registry. The study does not limit the number of centers or patients enrolled. Data collected includes baseline characteristics, treatment details at initial and any subsequent treatments, and disease stage through follow-up. Participants are involved through routine clinical care, with data recorded from birth through treatment and follow-up, which may extend up to about one year postnatal age. Researchers analyze treatment parameters at various points, such as initial treatment around 12 weeks and re-treatment up to 20 to 30 weeks. The registry tracks the natural history and clinical outcomes of ROP using routine clinical information without additional procedures.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.