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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.
Actively Recruiting
Healthy Volunteer
Researchers are conducting an international, prospective, multicenter, non-randomized observational study to confirm the safety and performance of the cervical disc prosthesis MOVE4-C. The study also aims to understand how patients quality of life changes after implantation and to assess the range of motion, which is important for implants that preserve movement. This research focuses on individuals with discopathy, herniated cervical discs, spinal stenoses, or radiculopathy. The study involves a single group of 170 patients who will receive a mono- or bisegmental implantation of the MOVE4-C cervical prosthesis. This device-based intervention is observed without randomization or a comparison group. The research collects clinical and radiological data to evaluate the devices performance over time. There are no placebo or blinded treatments involved. Participants will be followed up from baseline through 24 months after implantation. Researchers will assess improvements in neck disability, arm and neck pain using the Neck Disability Index and Visual Analogue Scales, as well as other health and function measures like the Core Outcome Measure Index, SF-36, EuroQoL, and Japanese Orthopedic Association Score. Range of motion and any adverse events related to the device will be monitored. The study includes clinical visits and evaluations to collect these outcomes and ensure safety throughout the follow-up period.
Actively Recruiting
Researchers are studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.
Actively Recruiting
Researchers are conducting a prospective registry study to observe and document the treatment and disease progression in patients with recurrent and metastatic prostate cancer. The study includes four distinct patient groups based on disease status those with biochemical recurrence after local treatment, non-metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer. Each group is enrolled and followed independently over different time periods to understand the course of therapy and disease. The study does not prescribe any specific treatment but records routine care as decided by each patients physician. Data collection occurs during routine clinical visits at set intervals, including after enrollment, every 3 to 6 months, and when therapy changes occur. Standardized quality of life questionnaires FACT-P and EQ-5D-5L are completed, and biological samples are collected to support comprehensive assessment. Participants are followed long-term, with an average follow-up of seven years. Researchers document therapy patterns, disease management strategies, imaging assessments, patient-reported outcomes, treatment adherence, and adverse events throughout this period. The focus is on real-world data reflecting everyday clinical practice, enabling a detailed understanding of treatment effectiveness and disease progression in prostate cancer patients.
Actively Recruiting
Real-World Evaluation of Risankizumab Treatment in Adults with Moderate to Severe Ulcerative Colitis
Ulcerative colitis UC is a chronic inflammatory bowel disease causing inflammation and bleeding in the rectum and large intestine. This research aims to assess changes in disease activity in adults with moderate to severe UC who are treated with risankizumab in real-world clinical practice. The study will observe approximately 200 adult participants prescribed risankizumab by their physicians in Germany and Austria. Participants will receive risankizumab as prescribed by their doctors according to the approved local label and routine clinical care. The study does not introduce additional treatments or procedures beyond what is normally provided. Participants will be followed for up to 52 weeks while continuing their usual medication schedule. Throughout the study, participants will attend regular hospital or clinic visits as part of their routine care. Researchers will track the percentage of participants achieving symptomatic remission using the Partial Adapted Mayo Score over about 52 weeks. There is no expected added burden, and participants will receive standard monitoring and care during this period.