Riesa

Researchers are evaluating how well insulin icodec helps people with type 1 diabetes control their blood sugar levels. This study focuses on participants who have never used insulin icodec before and aims to observe their treatment experience over a period of about 22 to 30 weeks. The study is designed as a real-world, multi-center, prospective observational study to assess glycemic control, treatment satisfaction, and adherence. Participants will be treated with commercially available insulin icodec as prescribed by their doctors, following usual clinical practice. There is no randomization or placebo group; all participants receive insulin icodec. The treatment period lasts approximately 22 to 30 weeks, during which participants continue their daily basal and bolus insulin regimen prior to starting insulin icodec. During the study, participants will have their blood sugar control monitored, including measuring changes in glycated hemoglobin (HbA1c) from baseline to week 26. Researchers will also assess treatment satisfaction and adherence. Participants must provide consent and be available for study visits and data recording throughout the study duration.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are evaluating the safety and effectiveness of the AcoArt drug-coated percutaneous transluminal angioplasty (PTA) balloon catheters in patients with symptomatic arterial disease affecting the lower limbs. This study includes patients with peripheral artery disease across a range of severity, classified by Rutherford Clinical Categories from 2 to 6, including both claudicants and those with critical limb ischemia. The study is a prospective, multi-center, single-arm post-market clinical follow-up to collect real-world data on these devices. Participants will be treated with one of three AcoArt drug-coated balloon catheters (Orchid, Tulip, or Litos), designed to open narrowed or blocked arteries in the iliac, superficial femoral, popliteal, or infra-popliteal regions. Treatments are performed according to current instructions for use and institutional standard practices. The study follows patients after treatment to continue monitoring the performance and safety of these devices in lower limb revascularization. During the study, patients will undergo protocol-specified examinations and follow-up visits to assess outcomes. Researchers will evaluate primary efficacy and safety endpoints at different time points depending on the severity group, including 30 days, 6 months, and 12 months after treatment. Data collected will include clinical assessments, monitoring for adverse events, and treatment success in improving blood flow and symptoms related to peripheral artery disease.

Researchers are collecting data in a registry study focused on adults with newly diagnosed or relapsed acute myeloid leukemia (AML). The study aims to gather detailed epidemiological information such as age, prognostic factors, and subgroup distributions. It also compares AML incidence and age distribution with population-based tumor registry data. Important clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival are being evaluated over a 10-year period. This study does not involve experimental treatments but instead documents current treatment strategies used in AML patients. Data collection occurs at 60 investigator sites across Germany, providing a broad overview of patient characteristics and management. There is no upper age limit, and all adult patients diagnosed according to WHO criteria, including acute promyelocytic leukemia, are eligible. Participants will be followed for up to 10 years, during which epidemiological parameters and survival outcomes will be monitored. Researchers will record relapse events, time until relapse, and survival status to understand long-term outcomes. This extensive follow-up intends to support improved knowledge about AML patient prognoses and treatment impacts over time.

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.

Researchers are collecting detailed information on adults diagnosed with Acute Lymphoblastic Leukemia (ALL) and related blood cancers such as other leukemias and certain types of Non-Hodgkin's Lymphoma. The purpose is to gather real-world data on diagnosis, treatments, and outcomes to support ALL research and improve quality of care. This registry includes patients whether or not they are part of other clinical trials. Participants included in this registry are adults aged 18 and older diagnosed with ALL or similar leukemias who are treated according to established ALL treatment protocols. It also includes patients with specific subtypes of Non-Hodgkin's Lymphoma treated according to B-ALL protocols. The study involves collecting clinical data and biological samples over time to understand treatment responses and disease progression. Throughout the study, researchers will monitor participants' health outcomes, including overall survival for up to 10 years. Data collected will cover diagnostics, treatments received, and patient outcomes in routine clinical care. This long-term follow-up aims to provide valuable insights into the effectiveness of current therapies and patient experiences with these blood cancers.

Immune thrombocytopenia (ITP) is a rare blood disorder where the immune system causes a shortage of platelets, leading to increased bleeding risk. New treatment options have emerged recently, but clinical studies often focus on specific patient groups. This research collects real-world data from a broad range of ITP patients to better understand the diagnosis, treatment, and outcomes in everyday care. The study also aims to improve personalized therapy and patient results by gathering detailed clinical and biospecimen information. The study involves creating a national registry where clinical data and biospecimens are collected from patients diagnosed with primary or secondary ITP. Data are gathered prospectively at defined points during the disease course, and patients can also be included retrospectively within 12 months of diagnosis if ongoing documentation is available. This includes information about disease factors, treatment types, complications, quality of life, fatigue, and survival over 5 years. Participants will provide written consent and undergo clinical assessments at enrollment and follow-up visits. Researchers will collect epidemiological data such as disease incidence, age and sex distribution, causes, treatment types, and remission status over 5 years. The registry also includes biospecimen collection to support high-quality, standardized research. This ongoing monitoring will help improve knowledge of ITP and support better patient care.