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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

This research aims to collect long-term safety and effectiveness information on commercially available Corin hip arthroplasty devices. It focuses on patients who have had hip replacement surgery using Corin implants, including those with primary, secondary, or post-traumatic osteoarthrosis, femur head necrosis, congenital dislocations, and revision surgeries. The study supports post-market surveillance and clinical evaluations of these devices. Participants are patients with hip implants from Corin. The study observes their outcomes over many years, starting during surgery and continuing up to 20 years after. Key evaluations include clinical performance, safety, radiological positioning and bone integration of the implants, as well as patient quality of life and satisfaction at various intervals. During the study, participants will undergo assessments at multiple time points including 3 months, 2.5 years, and up to 20 years after surgery. Researchers will collect data on implant outcomes, patient well-being, and implant safety. The main measure is the long-term outcome at 10 years, with additional follow-ups at 15 and 20 years to monitor ongoing performance and safety. The total duration of participation can extend up to 30 years from the start date.

Age: 18Years +All Genders
13 locations
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Actively Recruiting

Researchers are evaluating treatment intensification with docetaxel plus apalutamide and androgen deprivation therapy ADT in men with metastatic hormone-sensitive prostate cancer mHSPC who have not achieved a deep PSA response after initial treatment with apalutamide and ADT. This phase III, randomized, open-label, multi-center study aims to assess whether adding docetaxel improves event-free survival compared to continuing standard treatment with apalutamide and ADT alone. Approximately 320 male patients will be randomly assigned to one of two groups. The experimental group will receive docetaxel 75 mgm2 every three weeks for six cycles along with daily oral apalutamide 240 mg and ADT. The control group will continue with standard treatment of apalutamide and ADT alone. Randomization will consider factors like timing of metastasis, presence of visceral metastasis, and PSA levels at study entry. Safety will be regularly monitored by an independent data monitoring committee. Participants will be closely followed over 48 months to evaluate event-free survival, time to castration resistance, radiographic and PSA progression-free survival, overall survival, and quality of life measures. Other assessments include safety evaluations, skeletal event monitoring, and time to opioid use. Participants must meet specific health and laboratory criteria before enrollment and will be monitored throughout for treatment response and adverse events.

Age: 18Years +MALEPhase 3
56 locations