Wurselen

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab as first-line treatments for patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression. This Phase III, randomized, double-blind, and global study focuses on participants with stage IV mNSCLC who do not have certain genetic mutations or rearrangements and are eligible for systemic therapy. Participants receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two biological treatments given as monotherapy. Both groups will be monitored over time to assess treatment impact and safety. Throughout the study, participants undergo evaluations including tumor measurements by CT or MRI, performance status assessments, and organ function tests. Researchers will measure overall survival and progression-free survival for up to approximately five years. Tumor samples are collected before treatment for central testing, and participants’ health and treatment responses are closely followed during the trial period.

Researchers are conducting an international, prospective, multicenter, non-randomized observational study to assess the safety and performance of the MOVEC cervical disc prosthesis. The study also aims to understand how patients' quality of life changes after receiving the MOVEC implant and to analyze the range of motion, which is important for implants that preserve movement. The study focuses on adults diagnosed with discopathy, herniated cervical discs, spinal stenoses, or radiculopathy who have experienced neck and upper extremity pain or neurological deficits related to these conditions. Participants will receive either mono- or bisegmental implantation of the MOVEC cervical prosthesis. This device is designed to treat cervical intervertebral disc problems while maintaining motion in the spine. The study does not randomize participants but observes outcomes after the implantation. There are no additional treatment groups; all participants receive the MOVEC prosthesis. During the study, participants will be evaluated at baseline and again at 24 months after implantation. Researchers will measure improvements using the Neck Disability Index and Visual Analogue Scales for arm and neck pain. Data collection includes clinical and radiological assessments to monitor safety, performance, quality of life, and range of motion. Participants are expected to fully engage in the study and provide informed consent, with assessments continuing through the two-year follow-up period.

Researchers are studying both early and advanced/metastatic breast cancer to improve therapy decisions and healthcare quality. Metastatic breast cancer patients often have the poorest prognosis, and there is a need to better understand tumor characteristics to guide targeted therapies. This study aims to establish methods for analyzing molecular features of tumors and metastases using blood samples, as tumor biopsies can be invasive and are not routinely performed despite recommendations. Participants will have blood samples taken during routine blood draws to analyze tumor expression, mutations, gene copy number changes, and other molecular markers. The study focuses on creating a comprehensive infrastructure for molecular assessment in breast cancer patients at different stages. The research also explores healthcare outcomes and economics to enhance patient integration and awareness. Participants will be monitored to discover biomarkers that predict progression-free survival in metastatic breast cancer and assess disease-free survival in early breast cancer over up to 60 months. The study involves routine clinical assessments and blood collections, with data collected on tumor characteristics and patient health outcomes. Overall participation spans long-term follow-up to evaluate progression and survival measures.

Researchers are evaluating the treatment and disease progression in men with recurrent or metastatic prostate cancer through a long-term registry study. The study includes patients with four distinct prostate cancer conditions: biochemical recurrence after surgery or radiation, non-metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer. Each group is studied independently during different time periods to better understand their treatment courses and disease outcomes. There is no specific treatment assigned by the study. Instead, patients receive care according to the usual medical practice at their treatment centers. Treatments may vary and are decided by each patient's doctor. Data is collected at routine visits after enrollment, then every 3 or 6 months, and whenever therapy changes. This includes recording treatments, disease status, quality of life questionnaires (FACT-P and EQ-5D-5L), and collection of biomaterial. Participants will be involved in regular follow-up visits where their disease progression and therapy details are documented. The study monitors therapy frequencies and patterns for an average of 7 years. Researchers assess these long-term outcomes along with quality of life and other clinical data to better understand prostate cancer management in real-world settings.

Ulcerative colitis (UC) is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. This research evaluates the effectiveness of upadacitinib (RINVOQ), an approved treatment for UC, in adults with active moderate to severe UC. The study aims to understand the early therapeutic response and predict the long-term effectiveness of this medication. Upadacitinib will be given according to the approved local label and prescribed by the participant's physician as part of routine care. About 400 adult participants from Germany, Austria, and Switzerland who are starting upadacitinib treatment will be enrolled. Treatment decisions are made by the investigator independently of the study. Participants will be followed for up to two years, with no extra procedures beyond their standard care. During the study, participants will attend regular hospital or clinic visits where routine data will be collected and used for the study. Researchers will monitor the percentage of participants achieving symptomatic remission based on clinical response and intestinal ultrasound at week 8, with follow-up assessments at week 52. The study focuses on real-world treatment outcomes without adding extra burden to participants.

Ulcerative colitis (UC) is an inflammatory bowel disease causing inflammation and bleeding in the colon and rectum. This research aims to assess how treatment with risankizumab affects disease activity in adults with moderate to severe UC in real-world clinical settings. Risankizumab is an approved medication for UC, and the study will enroll about 200 adult participants across multiple sites in Germany and Austria. Participants will receive risankizumab as prescribed by their own doctors following routine clinical practice and according to local guidelines. There are no additional treatments or interventions beyond normal care. The study will follow participants for up to 52 weeks to observe changes in their disease activity while on this medication. During the study, participants will attend regular visits at hospitals or clinics as usual for their condition. Researchers will monitor the percentage of participants achieving symptomatic remission based on a standard scoring system over approximately one year. No extra burden beyond routine clinical visits is expected for participants throughout the study.