Bad Berka

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

Researchers are evaluating whether adding sacituzumab tirumotecan to pembrolizumab after surgery improves treatment outcomes for adults with resectable non-small cell lung cancer (NSCLC) who have not achieved a complete response after initial therapy. This Phase 3 study compares the combination of sacituzumab tirumotecan and pembrolizumab to pembrolizumab alone, focusing on disease-free survival as measured by a blinded independent central review. Participants receive neoadjuvant treatments including pembrolizumab with platinum-based doublet chemotherapy (such as cisplatin, pemetrexed, gemcitabine, carboplatin, or paclitaxel) before surgery. After surgery, those without a complete pathological response are randomized to receive either sacituzumab tirumotecan every two weeks for up to 24 weeks plus pembrolizumab every six weeks for up to 42 weeks, or pembrolizumab alone. Rescue medications may be given to prevent infusion reactions and oral side effects. During the study, participants undergo regular radiological assessments and provide tumor tissue samples to evaluate markers like PD-L1 and TROP2. Researchers monitor disease-free survival for up to approximately 93 months. Safety assessments, recovery from previous therapies, and control of infections such as HIV or hepatitis are also part of participant evaluations throughout the study period.

Researchers are evaluating the safety and effectiveness of a new combination treatment using BMS-986489 (a fixed dose combination of BMS-986012 and Nivolumab) alongside Carboplatin and Etoposide compared to the current standard treatment with Atezolizumab plus Carboplatin and Etoposide. This study focuses on adults with extensive-stage small cell lung cancer and is conducted as a phase 3 randomized, double-blind, multicenter trial. The goal is to find out which combination works better as a first-line therapy for this advanced lung cancer. Participants will receive either BMS-986489 combined with Carboplatin and Etoposide or Atezolizumab combined with Carboplatin and Etoposide. Each drug will be given at specified doses on certain days according to the study protocol. The study compares these two treatment approaches to see their effects and safety when used as initial therapy for extensive-stage small cell lung cancer. During the study, participants will be closely monitored over a period of up to 5 years to assess overall survival. Researchers will use imaging techniques like CT scans or MRIs to measure tumor response and will evaluate participants' health and ability to perform normal activities. Safety and side effects will also be tracked throughout the study to ensure participant well-being.

Researchers are evaluating whether ziltivekimab can help people who were hospitalized due to a heart attack by potentially reducing the development of heart disease and preventing new heart attacks or strokes. This Phase 3 study compares ziltivekimab with a placebo, which is a dummy medicine that has no effect on the body. Both treatments are given by chance, with equal likelihood for participants to receive either ziltivekimab or placebo. Participants will inject the study medicine once a month under the skin in the stomach, thigh, or upper arm. Ziltivekimab is given as an initial loading dose followed by monthly maintenance doses. The placebo group receives a matching injection schedule. The study duration is about two years. During the study, researchers will monitor participants for the time until the first serious heart-related event, including cardiovascular death, non-fatal heart attack, or non-fatal stroke. Participants will be closely observed from the start of randomization up to 25 months. The study includes regular follow-ups to assess safety and effectiveness of the treatments throughout this period.

Researchers are collecting detailed information on patients undergoing treatment for cardiac arrhythmias or implantation of cardiac electronic devices at the Heart Center Bad Berka. This observational registry aims to evaluate the safety, short-term success, and long-term outcomes of various arrhythmia therapies, including new technologies like pulsed field ablation and conduction system pacing. The study collects real-world data to support better clinical decisions and improve quality in cardiac electrophysiology. The registry includes patients receiving a range of treatments such as drug therapy, electrophysiological studies, catheter ablation for different arrhythmias, stroke prevention interventions, and device implantations. Data on procedure details, complications, acute treatment success, and patient outcomes are gathered prospectively. Substudies focusing on specific arrhythmias or technologies are also part of the registry. Participants will undergo assessments including procedural monitoring, imaging, device therapy evaluations, and patient-reported outcome collection during and after their treatment. Researchers will analyze safety and effectiveness, identify factors predicting arrhythmia recurrence or complications, and compare different technologies and methods. Participation does not alter clinical care, which remains under the treating physician's guidance, while the registry adheres to ethical and data protection standards.

Researchers are studying whether performing percutaneous coronary intervention (PCI) on all significant blocked arteries (multivessel complete PCI) is better than treating only the artery causing the current heart attack (culprit-lesion only PCI) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) who have blockages in multiple heart arteries. This trial is designed as a prospective, randomized, controlled, and open-label study conducted at multiple centers to compare these two treatment approaches for people with NSTEMI and multivessel coronary artery disease. Participants will be assigned to one of two groups: one receiving PCI only on the artery responsible for the heart attack (culprit-lesion revascularization), and the other receiving PCI on all significant blockages in the heart arteries (complete PCI). The procedures involve opening blocked arteries using standard catheter-based techniques. The study will monitor participants over an estimated average of two years to evaluate outcomes. During the study, researchers will track the combined rate of cardiovascular death or rehospitalization for a new heart attack as the primary outcome. Participants will be followed closely for up to two years, with regular assessments and medical monitoring to capture these events. This approach aims to determine which PCI strategy leads to better long-term heart health and fewer complications.

Researchers are evaluating the effects of maridebart cafraglutide, given alongside standard care, in reducing heart failure events such as hospitalizations, urgent visits, cardiovascular deaths, and improving symptoms in people with heart failure who have preserved or mildly reduced ejection fraction and are obese. This is a global phase 3, multicenter trial with a two-part design including a double-blind period followed by an open-label extension. The first part will end once around 850 key events have been recorded. Participants will receive either maridebart cafraglutide or a placebo, both administered by injection under the skin. The study includes an initial randomized, double-blind phase and a later open-label extension where all participants may receive the active treatment. The trial is designed to monitor participants over time to assess the safety and effects of the treatment compared to placebo. During the trial, participants will undergo assessments including monitoring for cardiovascular events, heart failure symptoms, and laboratory tests such as NT-proBNP levels. Researchers will track time until the first occurrence of cardiovascular death or heart failure events over approximately 35 months. Safety evaluations, adherence to treatment, and ongoing health status will be followed throughout the study period.

This research aims to collect data on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in repairing mitral valve problems, specifically mitral regurgitation and mitral insufficiency. The study focuses on patients who have undergone transcatheter mitral valve repair, evaluating how well these devices improve mitral regurgitation, functional status, and quality of life in a real-world, postmarket setting. Participants will receive treatment using the Edwards PASCAL and PASCAL Precision Transcatheter Valve Repair Systems for mitral valve repair. This study does not involve randomization or comparison groups but follows patients after their valve repair procedure to monitor outcomes. The devices are used according to approved indications after careful patient selection by a Heart Team. During the study, participants will attend follow-up visits where researchers will assess safety by tracking major adverse events within 30 days and evaluate effectiveness through changes in mitral regurgitation severity measured by echocardiography at discharge or seven days post-procedure. The study also monitors improvements in functional status and quality of life over time, requiring participants to complete all scheduled tests and visits to provide comprehensive data on the devices' performance.

Researchers are evaluating the safety and effectiveness of inhaled treprostinil in adults with progressive pulmonary fibrosis (PPF) over a period of 52 weeks. This Phase 3, multinational, randomized, double-blind, placebo-controlled study focuses on adults aged 18 and older who have PPF other than idiopathic pulmonary fibrosis (IPF) confirmed by lung imaging. Participants must show evidence of disease progression despite standard treatment for interstitial lung disease (ILD). Participants will be randomly assigned to receive either inhaled treprostinil or a placebo. Both are administered using an ultrasonic nebulizer delivering doses four times daily, starting at 3 breaths per dose and titrated up to a target of 12 breaths per dose as tolerated. The study includes six clinic visits during the treatment period at Weeks 4, 8, 16, 28, 40, and 52. After completing the 52-week visit, participants may have the option to join an open-label extension study. During the study, researchers will assess lung function through spirometry, measuring forced vital capacity (FVC), and monitor clinical worsening, acute exacerbations, survival, respiratory symptoms, and quality of life using questionnaires. Blood tests will measure biomarkers like NT-proBNP, and oxygen use and lung diffusion capacity will be tracked. Safety evaluations include monitoring adverse events, vital signs, lab tests, and heart function via ECG. The main outcome measured is the change in absolute FVC from baseline to Week 52.