Zwickau

Researchers are evaluating the retention rates of two treatments, upadacitinib UPA and tumor necrosis factor inhibitors TNFi, in adults with moderate to severe active rheumatoid arthritis RA in a real-world setting in Germany. This observational study aims to compare how long patients stay on each treatment when prescribed according to local standards and labels. About 678 participants will be enrolled over approximately 24 months, with total study duration lasting up to 48 months. Participants will receive either upadacitinib or a TNFi treatment as prescribed by their physicians following local regulatory and reimbursement guidelines. The decision to treat with UPA or TNFi is made independently of the study and before recruitment. The study does not assign treatments but observes patients already prescribed these therapies. During the study, researchers will monitor participants for up to 24 months to measure retention rates of the treatments. Data collection will include regular assessments according to routine care practices to track treatment persistence. The study focuses on real-world outcomes without altering standard treatment or care. Safety monitoring and follow-up will be conducted as part of usual medical care.

Researchers are evaluating the effectiveness, safety, and patient-reported outcomes of standard antimyeloma treatments in people with relapsed andor refractory multiple myeloma over a 24-month period. This observational study focuses on participants who have previously received treatment and aims to understand real-life clinical practice outcomes. The study is sponsored by Janssen Pharmaceutica N.V., Belgium, and collects data from routine medical care without interventional treatments. Participants with relapsedrefractory multiple myeloma receiving standard antimyeloma treatments as part of their regular clinical care will be observed. The primary source of data will be the participants medical records. There is no experimental drug or placebo involved. The study includes different observation periods to assess various outcomes related to response rates, disease progression, and quality of life. During the study, researchers will review participants medical records and track a wide range of outcomes including overall response rate, progression-free survival, adverse events, and health-related quality of life using validated questionnaires. The study follows participants for up to 52 months, monitoring treatment responses, safety, and patient-reported oral toxicities. This long-term observation helps to understand treatment effectiveness and patient experiences in everyday clinical settings.

This research aims to evaluate participant satisfaction with subcutaneous SC administration of ocrelizumab in people with multiple sclerosis MS. Participants include those diagnosed with relapsing-remitting MS RMS or primary progressive MS PPMS according to the 2017 McDonald criteria. The study focuses on assessing satisfaction after 12 months of treatment using the Therapy Administration Satisfaction Questionnaire subcutaneous TASQ-SC. Participants will receive ocrelizumab as a subcutaneous injection for the first time as part of their routine MS therapy, following their physicians judgment and local guidelines. The study observes treatment satisfaction over a 12-month period without altering standard care. Treatment administration is monitored in accordance with usual clinical practice. Throughout the study, participants will complete satisfaction questionnaires at baseline, 6 months, and 12 months. Researchers will also measure neurofilament light chain NfL protein levels in serum at these timepoints and analyze their correlations with MS relapse, disability scale scores, previous treatments, and other factors. Safety is monitored by recording adverse events up to 12 months. The study involves regular assessments to understand the effects of ocrelizumab SC on patient satisfaction and biological markers over one year.

Researchers are investigating the real-world use of encorafenib plus binimetinib for patients with unresectable advanced or metastatic melanoma that has a BRAF V600 mutation. This observational study focuses on documenting treatment effects, quality of life, safety, and tolerability after these drugs became commercially available in Germany, Austria, and Switzerland. The study specifically looks at patients treated in the first and second line settings after prior checkpoint inhibitor therapy. The study observes patients who are treated with encorafenib plus binimetinib according to the approved product guidelines. Participants may have started this treatment up to six months before joining the study or may begin treatment soon after enrollment. The study tracks treatment details, effectiveness, side effects, and patient-reported outcomes over a median treatment duration of about 12 months, with a total observation period of up to 90 months. Participants will be followed through regular documentation of their disease and treatment progress, including patient and disease profiles, treatment sequences, adverse events, and quality of life assessments using questionnaires. The main outcome measured is progression-free survival at 12 months after treatment start. Researchers will also evaluate treatment duration, interruptions, dose intensity, and physician satisfaction. Long-term safety and prognostic factors will be monitored throughout the observation period until study completion in September 2027.

Researchers are collecting data in a registry study for adults diagnosed with acute myeloid leukemia AML, including newly diagnosed and relapsed cases. The study aims to gather important information about the diseases epidemiology, such as patient age and prognostic factors, and to compare incidence and age distribution with population tumor registry data. It also evaluates key clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival. This observational study does not involve treatment assignment but documents treatment strategies used by patients. Data is gathered over a 10-year period to thoroughly monitor outcomes and disease patterns. The registry also collects information on complete remission rates, treatment-related mortality, therapy-associated morbidity, and quality of therapy and diagnosis. Additionally, the study seeks to validate known prognostic factors and explore new ones while describing new therapies and supportive care measures. Participants are adults aged 18 years and older diagnosed with AML according to WHO criteria, including acute promyelocytic leukemia. The study involves long-term follow-up with yearly assessments over 10 years. Researchers will evaluate epidemiological parameters and important survival outcomes. Since this is an observational registry, participants continue with their usual care while data is collected. The study is sponsored by Technische Universitt Dresden and involves multiple sites in Germany.

Atrial fibrillation is a common heart rhythm disorder that increases the risk of blood clots forming in the heart, which can lead to stroke. Patients who have had a stroke caused by bleeding in the brain intracranial bleeding face challenges with blood-thinning medications because these can cause further bleeding. This research compares two approved treatments to prevent stroke in such patients oral anticoagulation medications and a device that closes off a part of the heart called the left atrial appendage LAA. One group of patients will receive a minimally invasive procedure to close the LAA using a CE-marked device called Watchman or Watchman FLX. After closure, patients typically take aspirin and clopidogrel for three months, followed by aspirin alone for up to a year. Alternatively, some may take a short course of anticoagulants before aspirin. The other group will be treated with standard oral anticoagulation therapy as recommended by current guidelines. This study is randomized to fairly compare these two approaches for stroke prevention in patients with atrial fibrillation and prior brain bleeding. Participants will be followed for up to three years after treatment to monitor important outcomes such as survival free from stroke, systemic embolism, cardiovascular death, and bleeding events. Researchers will conduct evaluations to track these events and assess overall safety. The study aims to provide data to guide doctors in choosing the best prevention strategy for stroke in patients with atrial fibrillation who have experienced intracranial bleeding, potentially improving management and outcomes over time.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are collecting information on adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases like certain types of Non-Hodgkins Lymphoma. This observational registry gathers data from routine clinical care to support research and improve quality assurance. The study includes adults treated according to ALL or related treatment protocols, whether they are part of a clinical trial or not. This registry does not involve any specific treatments but collects detailed data on diagnosis, treatment, and outcomes. It prospectively gathers information on patient progress, including survival and remission rates, as well as biomaterial samples when available. The study monitors various types of leukemia and lymphoma subtypes treated under ALL protocols. Participants contribute by allowing their medical data and biomaterial to be collected and analyzed over time. Researchers track many outcomes such as overall survival, remission status, relapse rates, quality of life, and treatment-related side effects. Follow-up can extend up to 10 years, with ongoing evaluations to understand long-term health and treatment effects.

Researchers are evaluating treatments for adults with relapsed or refractory Acute Myeloid Leukemia AML in this multicenter, randomized clinical trial. The study compares high intensity reinduction chemotherapy with low intensity therapies to understand which approach provides better clinical benefit. This trial follows a pragmatic, clinical-oriented design and is funded by the European Commission to address the variability and emerging options in AML treatment. Participants receive either low intensity therapies, which include innovative and targeted drugs alone or combined with less-toxic agents and antibodies, or high intensity treatments involving high-dose chemotherapy agents, also possibly combined with antibodies or targeted drugs. Both treatment approaches are given according to local practice. The study is designed to reflect real-world care and includes patients in their first or second relapse or refractory AML. During the study, participants will be monitored for up to 36 months to assess outcomes such as event-free survival, overall survival, response rates, quality of life, and safety of the treatments. Researchers will collect data on clinical responses and patient-reported outcomes while tracking any side effects. Participants will have regular visits for evaluations and treatment as assigned, with ongoing follow-up to understand the long-term impact of the therapies.

Researchers are investigating the best timing for radiotherapy in women with high-risk breast cancer who have received neoadjuvant chemotherapy. The study compares preoperative radiotherapy to the standard postoperative radiotherapy to see if it improves disease-free survival and reduces radiation-related late side effects. This is a randomized phase III trial conducted internationally to address an important gap in breast cancer treatment. Participants are randomly assigned to receive either radiotherapy before surgery or the usual radiotherapy after surgery. Both treatments include radiation to the whole breast or chest wall, with additional boosts to the tumor bed when breast-conserving surgery is performed. If lymph nodes are involved, radiation to regional lymph nodes is also given. Treatments follow national and international guidelines and are carefully monitored. Throughout the study, participants will be followed for 6 to 10 years to assess disease-free survival as the main outcome. Researchers will also track local and regional recurrences, metastasis-free survival, overall and disease-specific survival, cosmetic results, quality of life, arm lymphedema, brachial plexus toxicity, and other treatment-related side effects. Regular evaluations by physicians and patient questionnaires will help monitor safety and effectiveness over the long term.