Singen Hohentwiel

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating how well once-weekly insulin icodec maintains blood sugar levels compared to daily basal insulin injections in adults with type 2 diabetes. The study focuses on people who need to start basal insulin treatment after using other glucose-lowering medications. This phase 4 trial aims to assess insulin icodecs effectiveness in real-world clinical practice over about 13 months. Participants will be randomly assigned to receive either weekly subcutaneous injections of insulin icodec or daily subcutaneous injections of basal insulin analogues such as insulin glargine, detemir, or degludec. The study compares these two insulin regimens as part of standard type 2 diabetes care. Treatment continues during the 52-week period to monitor blood sugar control and treatment satisfaction. Throughout the study, participants will undergo assessments including measuring changes in glycated hemoglobin HbA1c from baseline to week 52. They will also complete questionnaires on treatment adherence, satisfaction, and burden, and researchers will track severe hypoglycemia episodes and insulin doses. The trial spans about 13 months, providing thorough monitoring of treatment impact and safety in daily clinical use.

This research aims to evaluate participant satisfaction with subcutaneous ocrelizumab treatment in people with Multiple Sclerosis MS over a 12-month period. It will also investigate changes in neurofilament light chain NfL protein levels, a marker related to MS disease activity, and explore correlations between NfL levels and various clinical and imaging factors. The study is observational and follows participants who are starting ocrelizumab SC as part of their routine MS care. Participants will receive ocrelizumab as a subcutaneous injection according to their physicians discretion and local clinical practice. The study observes participants for up to 12 months to assess treatment satisfaction using the Therapy Administration Satisfaction Questionnaire for Subcutaneous administration TASQ-SC and other satisfaction questionnaires. Blood samples will be collected at baseline, month 6, and month 12 to measure NfL protein levels and other biomarkers. The study also monitors MS relapses, disability scores, and adverse events during this period. Throughout the 12 months, participants will undergo assessments of treatment satisfaction at multiple time points, including after the first injection, 6 months, and 12 months. Clinical evaluations, questionnaires, and blood tests will be conducted to track disease activity and participant experience. Researchers will measure satisfaction levels, changes in NfL concentrations, relapse rates, disability progression, and safety events. The study is designed to provide real-world data on patient experience and biomarker changes with subcutaneous ocrelizumab treatment in MS.

Researchers are investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive HR and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines Summary of Product Characteristics for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.

Researchers are investigating the effects of stopping CDK46 inhibitors in women with metastatic hormone receptor HR positive, HER2 negative breast cancer who have maintained disease control after long-term treatment. This phase II trial aims to evaluate whether disease stability continues when CDK46 inhibitors are discontinued after at least 12 months of combined treatment with endocrine therapy. The study is open-label, randomized, and conducted at multiple centers. Participants are randomly assigned to one of two groups one group continues both CDK46 inhibitor treatment such as Palbociclib or Abemaciclib and endocrine therapy, while the other group discontinues the CDK46 inhibitor but continues endocrine therapy alone. The study monitors disease progression and treatment effects over time, with a focus on how long patients remain free from disease worsening after stopping the CDK46 inhibitor. During the study, participants will be regularly assessed for disease progression, safety, and quality of life using questionnaires and clinical evaluations. Researchers will measure progression-free survival at 12 months and up to 54 months, time to treatment failure, time to first chemotherapy use, and monitor adverse events. The total participation duration may extend beyond four years, with ongoing evaluations to understand long-term outcomes and safety after stopping the CDK46 inhibitor.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

Researchers are studying patients who have experienced out-of-hospital cardiac arrest OHCA caused by heart-related issues. The goal is to better understand this condition by systematically collecting detailed information about patients medical background, treatment, and outcomes. This observational registry aims to improve care by analyzing data from a large number of patients in Germany, where many suffer from OHCA each year but survival with good brain function remains low. The study involves recording comprehensive data on each patient, including demographic details, psychosocial factors, disease progression, clinical and laboratory tests, and treatments received before, during, and after hospital care. There are no specific treatments assigned since this is an observational study focused on tracking and analyzing patient experiences and medical results. Participants will be followed throughout their hospital stay, which averages about two weeks, with researchers monitoring outcomes such as survival rates, length of intensive care and hospital stays, and health status at 6 and 12 months. This includes assessments of quality of life, mental health, cognitive function, and ability to reintegrate socially. The study aims to gather valuable information to guide future improvements in OHCA patient care.

Researchers are evaluating the effectiveness, safety, and economic benefits of coronary lithotripsy compared to other lesion preparation methods like cutting or super high pressure balloon angioplasty and ablative procedures. The study focuses on treatment of severely calcified coronary artery stenoses in patients with coronary artery disease. It is a randomized, double-blind trial sponsored by Deutsches Herzzentrum Muenchen. Participants receive lesion preparation either by intravascular lithotripsy using balloons with a rated burst pressure of up to 18 atm or by other standard methods such as high, super high, cutting balloons, and ablative techniques. These procedures are performed before intracoronary stenting. The trial compares these approaches to assess additional benefits in treating severely calcified coronary lesions. During the study, participants are monitored for major cardiac and cerebrovascular events over 12 months after randomization. Researchers also track mortality, myocardial infarction, stroke, need for vessel revascularization, stent thrombosis, hospitalization for acute coronary syndrome, and bleeding events. Symptom assessments for physical and mental health related to coronary heart disease and medical costs are also evaluated. Safety and procedural success are closely observed throughout the study period.

Researchers are evaluating the medicine pelacarsen TQJ230 compared to a placebo in adults with atherosclerotic cardiovascular disease ASCVD who have high levels of lipoproteina and are already receiving inclisiran treatment to lower their LDL cholesterol. This study is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial with a parallel group design to assess the efficacy, safety, and tolerability of pelacarsen. Participants will be randomly assigned to receive either pelacarsen injections once a month for 12 months or placebo injections once a month for 6 months, followed by pelacarsen injections for the remaining 6 months during an open-label phase. All participants also receive background inclisiran treatment consisting of two initial loading doses three months apart, followed by doses every six months as per approved guidelines. During the study, participants will have regular visits and assessments including laboratory tests to measure lipoproteina levels and monitor safety. Researchers will track changes in lipoproteina concentration at baseline and six months, along with adverse events and treatment tolerability over up to 16 months. The trial aims to understand how pelacarsen affects lipoproteina levels and overall safety when combined with inclisiran in this patient group.

Researchers are observing the real-world effects and patient experiences of trastuzumab deruxtecan T-DXd treatment in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This prospective, non-interventional study takes place in multiple centers in Germany and aims to collect patient-reported outcomes along with safety and efficacy data during routine clinical practice. Approximately 800 patients will be enrolled, divided evenly between HER2-positive and HER2-lowultralow cohorts. Participants will receive T-DXd treatment as prescribed by their doctors according to the approved product guidelines SmPC. Treatment and visit schedules are determined by the treating physician and are not fixed by the study protocol. Patients will also be informed about using a digital healthcare application DiGA during the study. The study includes two cohorts based on HER2 status, both receiving T-DXd in routine care. During the study, participants will be followed to measure the time until their next treatment or death, assessed for up to 60 months from the first T-DXd dose. Quality of life will be evaluated using questionnaires at six months after baseline. Patient safety and treatment effects will be monitored through data collected in routine clinical visits. The total participation period may extend up to eight years, allowing for long-term observation of treatment outcomes in real-world settings.