Gifhorn

Axial spondyloarthritis (axSpA) is an immune-related inflammatory disease mainly affecting the spine, causing chronic back pain and significantly impacting quality of life with symptoms like sleep problems, social isolation, and emotional distress. This research is evaluating the real-world effectiveness of the drug upadacitinib in controlling disease activity and managing pain in adults with active axSpA in Germany. Participants will receive oral upadacitinib tablets as prescribed by their doctors before joining the study, following local guidelines on dosage and treatment. The study will last about 52 weeks, during which participants will continue their prescribed treatment and attend regular medical visits as part of routine care. Throughout the study, researchers will monitor disease activity and treatment effects using medical assessments, side effect checks, and questionnaires. The main focus is on how many participants achieve and maintain low disease activity scores over 24 and 52 weeks, assessing both clinical and patient-reported outcomes related to pain and disease burden.

Heart failure with reduced ejection fraction (HFrEF) affects about half of the global heart failure population and presents a significant burden on healthcare. Despite advances in treatment, hospitalization and mortality rates remain high for HFrEF patients. Current guidelines recommend a combination of four drug classes for treatment, and recent updates suggest rapid in-hospital initiation and frequent follow-ups post-discharge. This study evaluates whether standardized physician training on these guidelines can improve real-world use of guideline-directed medical therapy (GDMT) and patient outcomes in Germany. The study focuses on patients hospitalized with HFrEF who receive treatment at Helios hospitals where physicians have undergone GDMT training. It observes the initiation and rapid increase of all recommended drug classes during hospital stays and at discharge. The study also examines how this approach translates into routine outpatient care, assessing the use of diuretics and other medications alongside GDMT. Participants will be monitored from hospital admission through discharge and into outpatient care, with assessments including heart failure symptoms, patient-reported outcomes, rehospitalization, and mortality. Researchers will track the proportion of patients receiving GDMT from baseline to discharge, typically around 6 days after hospitalization. The study aims to gather real-world data on treatment implementation and clinical outcomes in this patient group.

Researchers are evaluating the safety and effectiveness of GLSI-100 immunotherapy in people with HER2/neu positive breast cancer who are at high risk of the cancer coming back. This Phase 3 study focuses on individuals who have completed both neoadjuvant and postoperative adjuvant standard treatments, including trastuzumab-based therapy. The study includes participants who are HLA-A*02 positive, with an additional open-label arm for non-HLA-A*02 positive subjects, aiming to understand how this immunotherapy may help prevent invasive breast cancer recurrence. Participants receive treatment through a series of injections: six intradermal injections as the Primary Immunization Series over the first six months, followed by five booster injections given every six months. One group receives the investigational GLSI-100, which contains GP2 and GM-CSF, while a control group receives placebo injections containing normal saline. The open-label arm explores the treatment in non-HLA-A*02 positive subjects. Throughout the study, participants are monitored for invasive breast cancer-free survival over a median follow-up of four years, with interim analyses planned. Assessments include clinical evaluations to confirm no residual or persistent breast cancer, organ function tests, and pregnancy tests. Safety and efficacy data are collected to understand the treatment's impact, with participants followed closely during and after the treatment period to track outcomes and side effects.

Researchers are conducting a prospective, non-randomized, open-label, multicenter registry to evaluate the current treatment of three major cardiovascular diseases: heart failure, coronary artery disease, and atrial fibrillation. These diseases significantly contribute to illness and death, especially when they occur together. Although new therapies have been tested in randomized trials, there is limited data confirming their effects in real-world settings using a standardized approach. This study uses standard variable sets defined by the International Consortium for Health Outcomes Measurement (ICHOM) to objectively monitor disease progression and treatment outcomes. The study will build a cardiovascular registry collecting standardized patient information and outcomes based on ICHOM recommendations. It will observe how healthcare is utilized and how diseases and treatments interact in patients with heart failure, coronary artery disease, and atrial fibrillation. No investigational treatments or interventions are assigned, as this is a non-interventional observational study. Participants will be followed to collect clinical and patient-reported data during their inpatient treatment and beyond. The main outcomes measured include all-cause mortality at 6, 12, and 18 months of follow-up. The registry aims to gather comprehensive information on treatment effects and patient outcomes in routine clinical practice to improve understanding and management of these cardiovascular conditions.