Furth

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 collecting real-world data on patient outcomes to assess the success and performance of the Lifetech CeraFlex PFO Closure System, a device designed to close Patent Foramen Ovale PFO without surgery. This multicenter, prospective, observational study aims to provide valuable information on how well the device works in everyday medical practice. Participants will receive the CeraFlex PFO Closure System, which includes the CeraFlex PFO Occluder and the SteerEase Introducer. The study follows patients after the procedure, tracking their progress at discharge, and then at 1-3 months, 6 months, 12 months, and 24 months post-procedure. The enrollment period is expected to last about 18 months, with each participant followed for two years after device implantation. During the study, participants will undergo various assessments including monitoring for procedural success shortly after the procedure, checking for residual shunts at several follow-up points, and tracking stroke-related events, device deficiencies, serious adverse events, and deaths up to 24 months post-implantation. Data is collected electronically to ensure accurate tracking of patient outcomes over the entire study period.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy LNE improves overall survival in patients with stage I or II endometrial cancer who have a high risk of recurrence. The trial also looks at how LNE affects disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with specific histological types and stages of endometrial cancer will take part in this study. Participants will be randomly assigned to one of two groups. In Arm A, patients will undergo the standard surgical procedure including total hysterectomy and bilateral salpingo-oophorectomy, with an omentectomy added for certain cancer types. In Arm B, patients will receive the same standard surgery plus systematic pelvic and para-aortic lymphadenectomy reaching up to the left renal vein. The study compares these two surgical approaches. Throughout the study, participants will be monitored for overall survival over 60 months. Researchers will also assess disease-free and disease-specific survival at multiple time points up to five years. Serious complications will be recorded during surgery and follow-up visits. Quality of life will be evaluated regularly using standardized questionnaires. The number of lymph nodes removed will be documented during surgery to support the evaluation of treatment impact and safety.

Researchers are evaluating the use of a new device called the pressure microcatheter to measure the severity of coronary artery lesions in patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndrome ACS. This trial compares clinical outcomes of patients guided by the pressure microcatheter versus those guided by the conventional pressure wire during percutaneous coronary intervention PCI. The study aims to determine if the pressure microcatheter strategy is not worse than the pressure wire strategy for clinical decision making. Participants will be randomly assigned to receive PCI guided by either the pressure microcatheter or the pressure wire. After an angiographically successful PCI, patients will either undergo fractional flow reserve FFR-guided stent optimization using the assigned device or receive standard care treatment. The interventions are compared in four groups pressure microcatheter with optimization, pressure wire with optimization, pressure microcatheter with standard care, and pressure wire with standard care. Participants will be followed in hospital initially, then at 12 months, and yearly up to five years to monitor clinical outcomes. The study involves collecting data on major adverse cardiac events MACE, procedural times, resource use during hospitalization, post-PCI FFR measurements, and rates of symptoms and complications. This follow-up aims to assess safety, effectiveness, and long-term results of the two guidance strategies.

This research focuses on patients needing pacemaker or implantable cardioverter-defibrillator ICD implantation to avoid pacing-induced ventricular dyssynchrony. The study evaluates different pacing methods that maintain natural heart activation, such as His bundle pacing, left bundle branch area pacing, and conventional cardiac resynchronization therapy CRT. These methods aim to prevent negative effects linked to traditional right ventricular pacing, such as heart failure and atrial fibrillation, by preserving normal electrical heart function. Participants receive cardiac implantable electronic devices CIEDs implanted according to guidelines designed to maintain physiologic ventricular activation. The study observes these procedures as they occur, focusing on implantation success defined by stable lead placement and effective pacing thresholds. Researchers also track procedural details like venous access, duration, radiation exposure, and any adverse events. Data collected includes device performance and patient outcomes over time, including heart function assessments. During the study, participants undergo routine follow-up visits where device function, electrocardiograms, and echocardiograms are evaluated. Researchers monitor pacing system performance and clinical outcomes, correlating these with patient characteristics and procedural techniques. The study collects anonymized data in a secure database and expects to include around 200 patients. This observational study aims to advance understanding of the safety, effectiveness, and practical use of physiologic pacing methods.

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. This observational study collects both past and ongoing patient data to understand peri-operative device-related events better and improve care recommendations. The study is conducted at two centers and includes a broad range of patient characteristics and procedure types. The study involves patients with implanted CIEDs such as pacemakers, ICDs, or CRT devices undergoing non-CIED related surgeries or catheter interventions like radiofrequency ablation. Data are gathered retrospectively from records starting in 2008 and prospectively from ongoing patients. The focus is on documenting adverse device events related to procedures and any changes observed in device function before and after interventions. Participants provide data through routine clinical records, device interrogations, and procedural information. Researchers monitor adverse events related to devices during and after procedures, including device reprogramming or revisions needed. Outcomes like pacing threshold, sensing, and lead impedance are assessed at one month post-procedure. Data security is maintained with anonymized, password-protected records, and the study adds no additional risk to participants.

Researchers are investigating the effects of additional chemotherapy treatment after surgery or ablation in patients with metastatic colorectal cancer whose tumor lesions have been definitively treated. This phase III, open-label, randomized, controlled trial aims to compare the effectiveness, quality of life, and safety of mFOLFOXIRImFOLFOX-6 chemotherapy against active follow-up without additional chemotherapy. The study also includes a translational research component to analyze tumor biopsies and blood samples for disease relapse markers. Patients are assigned randomly in a 21 ratio to receive either active chemotherapy mFOLFOXIRI, mFOLFOX6, FOLFIRI, or CAPOX for up to six months or structured follow-up without chemotherapy. Chemotherapy regimens involve intravenous infusions and oral medications administered in cycles every two or three weeks, with a maximum of 12 cycles for most treatments. After treatment or follow-up, participants continue with structured monitoring for up to five years. Participants undergo re-assessments every three months during the first two years, including CT or MRI scans of the thorax and abdomen, blood tests, and quality of life evaluations to detect disease relapse. After two years without relapse, follow-up intervals extend to every six months. The primary outcome measured is progression-free survival at 24 months, with secondary outcomes including overall survival, lesion control, adverse events, and quality of life monitored for up to five years following randomization.

Researchers are studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.

Researchers are evaluating the safety and effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System in people with coronary artery disease who have atherosclerotic lesions longer than 36 mm and up to 44 mm in their native coronary arteries. The study focuses on lesions with a reference vessel diameter between 2.25 mm and 4.0 mm. This is a prospective, multicenter, single-arm study sponsored by Teleflex, aiming to treat subjects with these specific lesions using this device. Participants will receive the Orsiro Mission stent, which consists of a cobalt chromium stent platform coated with a bioabsorbable polymer containing the drug sirolimus. This device is designed to be implanted in the coronary arteries during percutaneous coronary intervention PCI. The study involves a single group receiving this stent to assess its performance in treating lesions of the specified length and size. During the study, participants will have follow-up visits to monitor outcomes and safety. Those enrolled in the United States will be followed for 2 years with visits at 1, 6, 12 months, and 2 years after the procedure. Participants outside the United States will be followed for 5 years with additional visits at 3 and 5 years. Researchers will measure target lesion failure at 12 months as the primary outcome and will also track device and procedure success, deaths, heart attacks, major cardiac events, revascularizations, and stent thrombosis throughout the follow-up period.

Researchers are evaluating the effectiveness and safety of a subcutaneous treatment using one cycle of cladribine for patients with hairy cell leukemia who need treatment. This study focuses on patients who are either untreated or have been previously treated only with alpha-interferon. The goal is to determine the rate of complete remission and to assess whether a second cycle of treatment benefits those with a non-optimal response, defined as detectable residual disease or partial remission four months after the initial treatment. Participants receive cladribine at a dose of 0.14 mgkg body weight administered subcutaneously as a bolus injection once daily for five consecutive days. After four months, remission status is evaluated. Patients showing non-optimal response may be considered for a second treatment cycle. This phase 23 trial is designed to optimize therapy for hairy cell leukemia by closely monitoring treatment response and toxicity. During the study, participants undergo evaluations including disease status assessment through bone marrow and blood tests, with a focus on remission rates four months post-treatment. Researchers track complete remission rates and monitor for residual disease. Safety is also monitored by assessing potential toxicities. Participants general health status and other laboratory tests are reviewed to ensure eligibility and ongoing suitability for treatment throughout the study period, which spans several months with follow-up assessments.