Oldenburg In Holstein

Primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) mainly affects patients aged 60 years or older and has a poor prognosis in this group. This trial compares two treatment strategies for elderly patients with newly diagnosed PCNSL who are eligible for high-dose methotrexate (HD-MTX). The study aims to determine whether a more intensive, shorter treatment approach including high-dose chemotherapy and autologous stem cell transplantation (HCT-ASCT) improves survival, response rates, and reduces toxicity compared to the conventional immunochemotherapy standard treatment. One treatment group receives the conventional R-MP regimen, which consists of three cycles of Rituximab, HD-MTX, and Procarbazine followed by maintenance with Procarbazine. The other group receives an induction treatment with Rituximab, HD-MTX, and Cytarabine (MARTA) for two cycles, followed by age-adjusted high-dose chemotherapy and autologous stem cell transplantation. This randomized phase III trial evaluates these two approaches to establish the optimal first-line treatment for elderly PCNSL patients. Participants will be assessed for survival without disease progression for up to six years. The trial includes various evaluations such as geriatric assessments to determine transplant eligibility, response to treatment, quality of life, and treatment-related side effects. Patients will be closely monitored throughout the study to collect data on remission, survival, and safety to inform future treatment standards for this vulnerable population.

Researchers are evaluating the safety and effectiveness of a medicine called NNC0487-0111 for adults with excess body weight, specifically targeting obesity. This Phase 3 clinical study aims to see if this treatment helps people maintain their weight loss compared to a placebo, which contains no active medicine. Participants are randomly assigned to either the treatment or placebo group to fairly compare results. The study involves two groups receiving weekly injections under the skin: one group gets NNC0487-0111, and the other receives a placebo designed to look the same. The treatment is given once a week, and participants reach a target dose during an initial run-in period before the main study phase begins. During the study, researchers track changes in body weight from week 40 to week 92 to assess how well the treatment works. Participants' safety and health are monitored throughout the study, including various medical assessments. The total participation time covers these weeks and includes ongoing observation to understand the treatment's effects over time.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

This research focuses on evaluating the use of intravenously administered fosfomycin to treat severely infected patients across Europe. It includes those with serious infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis and central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections as permitted by national guidelines. The study is prospective, multicenter, non-interventional, and aims to document both the effectiveness and safety of this treatment. Patients receive fosfomycin treatment according to the national Summary of Product Characteristics (SmPC) guidelines for fosfomycin intravenous use. The study does not involve comparing treatment groups or altering standard care but observes patients receiving fosfomycin in routine clinical settings. There are no specific dosing schedules or additional interventions imposed by the study protocol. During the study, participants are monitored until the end of treatment, which may last up to six months after starting fosfomycin. Researchers evaluate clinical success by assessing whether patients achieve clinical cure or improvement. Safety and outcomes are recorded through clinical observations, with the goal of better understanding fosfomycin's role in treating severe infections.

Researchers are evaluating the safety and effectiveness of three different doses of frexalimab compared to a placebo in people with newly diagnosed Type 1 Diabetes (T1D) who are already receiving insulin treatment. This is a Phase 2, randomized, double-blind study with a 52-week blinded extension and an optional open-label extension, aiming to preserve the pancreatic beta-cell function in adults and adolescents aged 12 to 35 years. The study assesses changes in C-peptide concentration over 52 weeks as a primary outcome measure to understand how well the pancreas continues to produce insulin. Participants receive frexalimab or placebo starting with an intravenous infusion on Day 1, followed by subcutaneous injections from Week 2 to Week 102. Insulin therapy continues alongside, with doses adjusted by the investigator. The study includes a screening period of 3 to 5 weeks, a main double-blind treatment period lasting 52 weeks, a 52-week blinded extension, and an optional 104-week open-label extension. After treatment, participants undergo up to 26 weeks of safety follow-up. Throughout the study, participants will have regular assessments including mixed meal tolerance tests to measure C-peptide levels, along with monitoring of safety and efficacy. Researchers will collect data on insulin usage, adverse events, and other health parameters over the total study duration of up to 135 weeks. This comprehensive follow-up helps evaluate the long-term effects of frexalimab on insulin secretion and participant health.

Researchers are evaluating a new combination treatment of Sigvotatug Vedotin plus pembrolizumab compared to pembrolizumab alone in adults with non-small cell lung cancer (NSCLC) that has high levels of PD-L1 protein. This study focuses on participants with advanced or metastatic NSCLC (Stage 3 or 4) who have PD-L1 expression in at least 50% of their tumor cells. The purpose is to understand how well the combination works versus pembrolizumab alone as a first treatment option. All participants receive pembrolizumab through an intravenous infusion once every 6 weeks at the study clinic. Half of the participants will also receive Sigvotatug Vedotin as an intravenous infusion every 2 weeks along with pembrolizumab. Participants may continue pembrolizumab treatment for up to about two years, while those receiving Sigvotatug Vedotin can continue until their cancer no longer responds to the treatment. During the study, participants will have regular clinic visits where researchers monitor their health and response to treatment. The main outcomes measured include overall survival up to approximately two years and progression-free survival, which tracks the time until cancer worsens or death. Safety and side effects will be closely observed throughout the study period to understand the treatments' impact.