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Actively Recruiting

Researchers are evaluating a new approach to managing hypertension by combining usual care visits with a mobile app called the ESH CARE App. This study focuses on comparing this innovative strategy, called POST (Patient Optimal Strategy for Treatment), with standard care over one year. The goal is to see if this approach improves blood pressure control, including office, home, and ambulatory measurements, and affects cardiovascular and kidney health markers. Participants are randomly assigned to either the POST strategy or usual care. Those in the POST group use the ESH CARE App to send home blood pressure readings twice weekly, with therapy adjustments made every 15 days based on these values. The usual care group receives therapy adjustments every three months based on office blood pressure readings. Both groups attend visits at baseline, three, six, and twelve months, where various tests and measurements are performed. Throughout the study, participants undergo physical exams, blood pressure monitoring, ECGs, echocardiograms, and urine and blood tests to assess kidney function, heart health, and blood pressure changes. Home blood pressure is measured regularly, with more frequent monitoring in the POST group. The primary outcome measured is ambulatory systolic blood pressure at 12 months, with additional assessments of other blood pressure types and organ health indicators. The study lasts one year with closely monitored follow-up visits.

Age: 18Years - 80YearsAll GendersPhase Not Applicable
8 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of a new antibody drug called gotistobart (ONC-392/BNT316) compared to the chemotherapy drug docetaxel in patients with metastatic non-small cell lung cancer (NSCLC) whose disease has worsened after treatment with PD-1 or PD-L1 inhibitors. This Phase 3 clinical trial aims to see if gotistobart can help patients live longer than with standard chemotherapy. The study will enroll about 630 patients who have squamous cell NSCLC and have shown disease progression on prior immunotherapy. The trial has two stages. In Stage I, two different dosing regimens of gotistobart will be tested against docetaxel to confirm the best dose. Gotistobart is given through a 60-minute intravenous infusion every 21 days at either 3 mg/kg or 6 mg/kg (with two initial loading doses of 10 mg/kg). Docetaxel is given by IV infusion every 21 days at 75 mg/m2. Stage II will compare the chosen gotistobart dose to docetaxel in patients with squamous NSCLC. Treatment will continue for up to 17 cycles, approximately one year. Participants will undergo tumor measurements to confirm disease progression and meet health criteria such as organ function and performance status. Researchers will monitor overall survival over 36 months as the main outcome. Safety and side effects will be closely followed. The study requires patients to have recovered from prior treatment effects and have no active infections or serious heart or lung disease. Through this trial, researchers hope to determine whether gotistobart is a beneficial treatment option for this group of lung cancer patients.

Age: 18Years +All GendersPhase 3
152 locations
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