Furth

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are collecting real-world data to evaluate the outcomes and procedural success of the Lifetech CeraFlex PFO Closure System, a device designed to close Patent Foramen Ovale (PFO) without surgery. This prospective, observational, single-arm study involves multiple centers and aims to understand how well the device performs in patients who have conditions like recurrent migraine, transient ischemic attack (TIA), or cryptogenic stroke associated with PFO. The study uses the CeraFlex PFO Closure System, which includes the CeraFlex PFO Occluder and the SteerEase Introducer. The device is inserted percutaneously through a catheter to close the PFO. Participants will be followed for 24 months after the procedure, with assessments at discharge, and at 1-3 months, 6 months, 12 months, and 24 months. Data will be collected electronically to monitor the device’s performance and patient outcomes. Participants will undergo scheduled follow-up visits where researchers will evaluate procedural success within 7 days after the procedure or at discharge, whichever comes first. Throughout the 24-month follow-up, participants will have regular check-ins to assess their health status and the device’s function. This study helps provide important information on the safety and effectiveness of the CeraFlex PFO Closure System in everyday clinical settings.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy (LNE) improves overall survival in women with stage I or II endometrial cancer who have a high risk of recurrence. The study also aims to assess the impact of LNE on disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with confirmed high-risk endometrial cancer will be included in the trial. Participants will be randomly assigned to one of two groups. In the first group, patients will undergo a total hysterectomy and bilateral salpingo-oophorectomy, with an additional omentectomy if they have serous or clear cell cancer types. The second group will receive the same procedures plus systematic pelvic and para-aortic lymphadenectomy up to the level of the left renal vein. This approach allows comparison between standard surgery and surgery with lymphadenectomy. During the study, patients will be monitored for overall survival over 60 months. Researchers will also evaluate disease-free survival and quality of life, while tracking complications and side effects of the treatments. Informed consent will be obtained, and patients’ compliance and health status will be regularly assessed. The trial includes close follow-up to observe long-term effects and outcomes of the surgical procedures.

Researchers are evaluating the use of a new device called the pressure microcatheter compared to the traditional pressure wire in guiding treatment decisions and optimizing percutaneous coronary intervention (PCI) for patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndrome. This Phase 4, multicenter, randomized, open-label trial aims to see if clinical outcomes with the pressure microcatheter are not worse than those with the pressure wire. The pressure microcatheter is designed to provide similar physiological measurements while being easier to use during the procedure. Participants will be randomly assigned to one of four groups: pressure microcatheter guided strategy with incremental optimization (PIOS MC), pressure wire guided strategy with incremental optimization (PIOS PW), pressure microcatheter guided strategy with standard care, or pressure wire guided strategy with standard care. Each group will receive PCI guided by their assigned device, followed by either the incremental optimization strategy or standard care treatment as described. The study device is used during the PCI procedure to measure lesion severity and help guide treatment. During the study, patients will be monitored in the hospital and followed up at 12 months, then yearly for up to five years. Researchers will compare major adverse cardiac events (MACE) occurring within 12 months between the two device strategies. Assessments will include clinical evaluations and tracking of outcomes related to heart health and procedure success. This long-term follow-up will help determine the safety and effectiveness of using the pressure microcatheter compared to the pressure wire in guiding PCI.

Researchers are collecting new real-world data on first-line treatment for women newly diagnosed with advanced high-grade epithelial ovarian cancer in Germany. This study aims to understand how maintenance treatment with Poly ADP ribose polymerase inhibitors (PARPi) affects routine medical care, patient outcomes, and treatment sequences, especially in those undergoing surgery and chemotherapy. It also explores patient-reported experiences, physician insights, genetic testing practices, and drug safety in this setting. The study observes patients receiving first-line platinum-based chemotherapy, including those who have completed primary debulking surgery. It includes patients who have started or are planning to start chemotherapy, with the total number of chemotherapy cycles tailored by the treating physician. Women of childbearing potential must use reliable contraception during the study. The study does not involve any experimental interventions but monitors treatments as they occur in regular clinical practice. Participants will be followed to evaluate progression-free survival and other outcomes up to 84 months from the start of chemotherapy. Patient-reported outcomes will be collected electronically to capture experiences and needs during and after maintenance therapy. The study also tracks the use of BRCA/HRD testing, treatment safety, and physician experiences to better understand care patterns and long-term results in routine clinical settings.

Researchers are investigating pacing methods that aim to maintain natural ventricular activation during cardiac device implantation to prevent ventricular dyssynchrony and its negative effects. This observational study focuses on evaluating the success, safety, and outcomes of physiological pacing approaches such as His bundle pacing, left bundle branch area pacing, and cardiac resynchronization therapy. These methods are being studied as alternatives to conventional right ventricular pacing, which may cause heart dysfunction, heart failure, and atrial fibrillation. The study involves implanting cardiac implantable electronic devices (CIEDs) according to current guidelines to avoid pacing-induced dyssynchrony. Various pacing techniques target specific heart areas: the His bundle for His bundle pacing, the right interventricular septum for left bundle branch area pacing, and the coronary sinus or intrinsic conduction system for cardiac resynchronization therapy. The primary goal is to achieve stable lead placement with effective pacing thresholds. The study collects data on procedural details, device performance, and patient outcomes. Participants undergo device implantation and are followed over time through routine clinical evaluations including ECG, echocardiography, and heart failure assessments. Researchers monitor implantation success, device function, adverse events, and clinical outcomes during follow-up visits. The study is conducted at a single center with ongoing patient enrollment, collecting anonymized data to analyze the safety and effectiveness of these physiologic pacing methods in real-world use.

Researchers are evaluating the management and outcomes of patients with implanted cardiac electronic devices (CIED) who undergo surgeries or catheter-based procedures unrelated to their device. The study aims to improve recommendations for perioperative care and device programming using data collected from routine clinical settings. This observational registry includes both retrospective and ongoing prospective patient enrollment and involves two medical centers specializing in heart and lung diseases and heart surgery. The study focuses on patients who have an implanted CIED such as a pacemaker, ICD, or CRT and who undergo non-CIED related surgical or catheter-based procedures like radiofrequency ablation. Data are collected from patient histories, clinical records, and device interrogations before, during, and after the procedures. The study does not involve experimental treatments but monitors existing clinical practices and device management. Participants provide data through routine clinical documentation including pre-procedural patient characteristics and device checks, details of the surgical or catheter intervention and anesthesia techniques, any adverse events, and post-procedural device assessments. The primary outcome is the occurrence of surgery or catheter procedure-related adverse device events within one month after the procedure. The study expects to include data from over 500 patients and more than 700 interventions, with strict data security and anonymization measures in place.

The trial investigates the effectiveness, safety, and patients' quality of life when using additive chemotherapy after surgery or ablation in patients with metastatic colorectal cancer. This phase III, open-label, randomized, controlled, multicenter study compares two groups: one receiving chemotherapy and the other undergoing active follow-up without additional treatment. All patients have had their metastatic lesions definitively treated before joining the trial. Participants in the chemotherapy group receive up to six months of treatment with either mFOLFOXIRI or mFOLFOX-6, with up to 12 cycles administered every two weeks. The other group undergoes active surveillance without further chemotherapy. The study includes regular tumor biopsies at screening and upon relapse if possible, aiming to study tumor and blood markers. Imaging scans such as CT or MRI of the chest and abdomen are performed every three months during the first two years, then every six months thereafter, with follow-up continuing for up to five years. Throughout the study, patients are monitored every three months with radiologic assessments, blood tests, and quality of life questionnaires. Researchers aim to detect any cancer relapse through imaging and blood markers and evaluate progression-free survival over 24 months. Safety and clinical status are regularly assessed, and structured follow-up is maintained for both groups up to 60 months after randomization.

Researchers are studying both early and advanced/metastatic breast cancer to improve therapy decisions and healthcare quality. Metastatic breast cancer patients often have the poorest prognosis, and there is a need to better understand tumor characteristics to guide targeted therapies. This study aims to establish methods for analyzing molecular features of tumors and metastases using blood samples, as tumor biopsies can be invasive and are not routinely performed despite recommendations. Participants will have blood samples taken during routine blood draws to analyze tumor expression, mutations, gene copy number changes, and other molecular markers. The study focuses on creating a comprehensive infrastructure for molecular assessment in breast cancer patients at different stages. The research also explores healthcare outcomes and economics to enhance patient integration and awareness. Participants will be monitored to discover biomarkers that predict progression-free survival in metastatic breast cancer and assess disease-free survival in early breast cancer over up to 60 months. The study involves routine clinical assessments and blood collections, with data collected on tumor characteristics and patient health outcomes. Overall participation spans long-term follow-up to evaluate progression and survival measures.

This research aims to evaluate the safety and effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in treating patients with coronary artery disease who have atherosclerotic lesions between 36 mm and 44 mm in length in native coronary arteries with a vessel diameter of 2.25 mm to 4.0 mm. The study includes patients from the United States and other countries, with different follow-up durations based on location. Patients in the United States are followed for 2 years after the initial procedure, while those outside the United States are followed for 5 years. Participants will receive the Orsiro Mission stent, which is a device combining a cobalt chromium stent platform with a sirolimus drug contained in a bioabsorbable polymer coating. This stent is designed to be placed in the coronary artery to treat the lesion with a single device. The treatment targets one lesion per patient, with certain allowances for additional non-target lesion treatments using other approved methods if needed. Throughout the study, participants will have scheduled follow-up visits to monitor their health and the performance of the stent. In the United States, visits occur at 1, 6, 12, and 24 months after the procedure, while outside the United States, additional visits at 3 and 5 years are included. Researchers will assess the rate of target lesion failure at 12 months and monitor safety and device effectiveness through clinical evaluations and imaging as appropriate.