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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

Age: 18Years +All GendersPhase 2
221 locations
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Actively Recruiting

This trial evaluates inclisiran, a subcutaneous injection given twice yearly, for preventing major cardiovascular and limb events in patients who have undergone percutaneous coronary intervention PCI or peripheral endovascular intervention PVI. The study focuses on patients with atherosclerotic cardiovascular disease, including coronary artery disease and peripheral artery disease, aiming to assess inclisirans role alongside standard care in real-world settings. It is a randomized, double-blind, placebo-controlled, phase 4 study involving about 6,000 participants. Participants will receive either 300 mg of inclisiran or a matching placebo by subcutaneous injection on Day 1 within 14 days of their intervention, at Month 3, and then every 6 months thereafter. The study compares inclisiran to placebo while all participants continue their usual care prescribed by their physicians. The treatment duration varies with event accrual and follow-up but is expected to last approximately 4 years, with individual participants receiving treatment for up to about 45 months. Throughout the study, participants will be regularly monitored for major adverse cardiovascular events MACE and major adverse limb events MALE up to about 4 years from randomization. Additional assessments include tracking cardiovascular death, all-cause death, and venous thromboembolic events. The study includes safety monitoring and follow-up visits to evaluate the outcomes and adherence to the intervention and usual care during the entire study period.

Age: 18Years +All GendersPhase 4
125 locations
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating telehealth self-management coaching sessions to improve quality of life for people who have survived pancreatic cancer and their family caregivers. Pancreatic cancer and its treatments often cause many symptoms that can negatively affect well-being, and there are few quality of life programs available to support patients and their families during treatment. This trial aims to see if telehealth coaching can help manage physical symptoms and support emotional, social, and spiritual well-being for both patients and caregivers. Participants in the study are divided into two groups. One group attends telehealth coaching sessions lasting 40 to 60 minutes every two weeks for a total of 6 sessions over 3 months. The other group receives the usual standard of care without additional coaching. Both patients and their family caregivers take part in the intervention sessions and assessments. During the study, researchers collect information on patient-reported quality of life at the start and after 3 months. They also track symptom severity, psychological distress, caregiver burden, and overall survival over 6 months. Participants complete questionnaires and interviews at various time points, and the study monitors enrollment, completion rates, and participant experiences. The total participation time may extend up to 6 months to gather follow-up data and evaluate the impact of the coaching sessions.

Age: 18Years +All GendersPhase Not Applicable
22 locations