Cooperstown

Researchers are studying real-world patient characteristics, treatment patterns, and both short- and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy HCM across the United States and Europe. The study focuses on patients receiving mavacamten, other treatments for obstructive HCM, or no treatment due to intolerance or prior treatment failure. The U.S. portion evaluates the safety of mavacamten in this setting, while the European part assesses both its effectiveness and safety. Participants receive treatments as part of standard care, either mavacamten or other medications such as beta-blockers, non-dihydropyridine calcium channel blockers, or disopyramide. Treatments are prescribed by physicians according to routine clinical management. The study observes outcomes over time without altering prescribed care. During the study, participants are monitored for changes in heart function, symptoms, and adverse events through clinical assessments including echocardiography and patient-reported questionnaires. Researchers evaluate heart failure events, heart function measures like left ventricular outflow tract gradient and ejection fraction, arrhythmias, hospitalizations, mortality, and quality of life scores. Data is collected at baseline and followed for up to five years to understand real-world treatment effects and safety.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are conducting a multi-center clinical study to evaluate the safety and effectiveness of Alpha DaRT, a device that emits alpha radiation, combined with chemotherapy for patients with locally advanced or metastatic pancreatic cancer. The study aims primarily to assess the safety of this combination by monitoring device-related adverse events. Additionally, the study will evaluate the treatments effectiveness by looking at overall and progression-free survival, pain control, and the rate of surgical resection in patients with locally advanced cancer. Participants are divided into two groups based on their cancer stage one with locally advanced pancreatic cancer and the other with metastatic pancreatic cancer. Each group will receive chemotherapy regimens such as mFOLFIRINOX or GemcitabineAbraxane. During the first four cycles of chemotherapy, patients will undergo placement of the Alpha DaRT device, which is inserted into the tumor via endoscopy and releases short-lived alpha-emitting atoms to target the cancer. Throughout the study, participants will be closely monitored for safety and treatment response. Assessments include tracking serious adverse events for up to 24 months, evaluating pain response 30 days and two months after the procedure, and determining the percentage of locally advanced cases that become surgically resectable at six and 24 months. Follow-up continues for six months after enrollment to observe outcomes and side effects, providing a comprehensive overview of the treatments impact over time.

This trial evaluates the safety and effectiveness of intratumoral Alpha DaRT-224, a device delivering diffusing alpha-emitter radiation, in treating immunocompromised patients with cutaneous squamous cell carcinoma SCC. The study aims to measure the objective response rate ORR using RECIST v1.1 criteria and track progression-free survival PFS, overall survival OS, and local tumor control up to 12 months after treatment. It is a multicenter, single-arm, open-label clinical study involving up to 28 participants. Participants will receive DaRT seeds, which are encapsulated Radium-224 radioactive sources inserted directly into the SCC tumor. These sources emit short-lived alpha particles locally in the tumor microenvironment. The seeds remain implanted for 14 to 21 days before removal. The treatment targets tumors up to 7 cm in size with single lesions that can be fully covered by the radiation sources. The study does not include a comparison group. During the study, participants will undergo multiple CT scans and blood tests to monitor tumor response and safety. Researchers will assess the best overall tumor response starting from the time of DaRT seed removal. Adverse events related to the device will be classified and recorded according to established criteria. Patients must provide informed consent and will be followed for up to 12 months after seed insertion to evaluate survival and tumor control outcomes.

This research aims to evaluate the performance of the Perosphere ClotChek173 system, a hand-held, battery-operated blood coagulation device used at the point-of-care, in measuring whole blood clotting time WBCT in patients taking direct oral anticoagulants DOACs such as rivaroxaban or apixaban. The study focuses on characterizing how well this device can quantitatively assess clotting times in these patients compared to normal controls. Participants provide fresh whole blood samples taken at various times during the day to capture a range of clotting times rather than strict peak or trough measurements. The blood is loaded onto disposable cuvettes without biological reagents for testing with the Perosphere ClotChek173 device. This observational study collects these samples to analyze clotting times and device performance in relevant patient subgroups, including those with renal or hepatic impairments. During the study, participants will undergo venipuncture to provide non-citrated whole blood samples for the clotting time measurements. Researchers will evaluate the devices ability to distinguish between patients on rivaroxaban or apixaban and normal controls. Safety and patient history will be reviewed to ensure eligibility, and clotting times will be assessed on the day of sampling. The study is expected to run until June 2027, with participants involved in a single visit for sample collection and device evaluation.

Researchers are evaluating a treatment approach for early-stage hormone-sensitive, HER-2 negative breast cancer with an Oncotype recurrence score of 18 or less. This Phase III trial compares breast conservation surgery with endocrine therapy alone against breast conservation surgery with both radiation and endocrine therapy. The goal is to see if skipping radiation after lumpectomy is not worse in preventing cancer recurrence in the same breast. Participants will be randomly assigned to one of two groups. One group will receive radiation therapy to the breast plus at least five years of endocrine therapy with drugs such as Tamoxifen, Anastrozole, Letrozole, or Exemestane. The other group will receive endocrine therapy only for at least five years without radiation. Radiation must start within 12 weeks of surgery if assigned. Endocrine therapy dosing and schedule are determined by the treating doctor. During the study, participants will have regular follow-ups up to five years to monitor cancer recurrence in the breast and elsewhere, survival, and breast preservation. Assessments will include clinical exams, imaging like mammograms or MRI, and pathology reviews. The main outcome is time to invasive or noninvasive breast tumor recurrence within five years. Some measures will continue through an average of 15 years, including breast conservation rates. Safety and overall health will be monitored throughout and after treatment.

Researchers are evaluating different treatment approaches for patients with newly diagnosed rectal cancer, focusing on those in rural settings. The study observes patients who choose either surgical or non-surgical management after neoadjuvant therapy, aiming to understand patient preferences, adherence to follow-up, and quality of life over approximately six years. Surgery for rectal cancer can have significant side effects, and emerging evidence suggests some patients with complete response to initial treatment may avoid surgery without worsening outcomes, though this is still under study especially in rural populations. Patients will receive one of three standard treatment options involving chemotherapy and radiation before any surgery decision. Following neoadjuvant therapy, patients are restaged using physical exams, imaging, and blood tests to assess tumor response. Those with complete response may choose between surgery or intensive non-operative follow-up, which includes frequent endoscopy and imaging. Treatment interruptions may occur for severe side effects. Operative patients undergo surgery followed by chemotherapy or surveillance, while non-operative patients complete chemotherapy or begin surveillance directly. Participants will have clinic visits and complete surveys on pain, quality of life, and satisfaction at multiple points before, during, and after treatment. Monitoring includes blood tests, endoscopy, MRI or ultrasound, and CT scans at scheduled intervals for up to five years. Researchers will measure patient treatment preferences, adherence to surveillance, and quality of life outcomes. The study is observational, tracking how these treatments impact patients in a rural healthcare context over time.

Researchers are evaluating a master screening protocol called Lung-MAP for patients with previously treated non-small cell lung cancer. This phase IIIII trial aims to develop a genomic screening method for large cancer populations and assign participants to appropriate sub-studies based on specific cancer biomarkers. The goal is to compare new targeted therapies designed to block cancer growth or spread with standard care, including sub-studies for patients not eligible for biomarker-driven treatments. The study involves screening patient specimens to determine eligibility for various biomarker-driven or non-matched sub-studies within the Lung-MAP umbrella protocol. This is a screening study without direct interventions instead, patients are assigned to different treatment sub-studies, each operating independently. The protocol also includes an optional ancillary study evaluating attitudes about the return of somatic mutation findings suggestive of germline mutations. Participants provide tumor tissue for biomarker testing, including molecular profiling and PD-L1 analysis, and may submit fresh biopsies and blood samples for circulating tumor DNA testing. Researchers will monitor screening success rates up to three years and collect patient and physician feedback on genetic findings. Participation involves signing informed consent, providing smoking history, and possibly completing surveys. The study duration and assessments vary depending on sub-study assignment and patient progression.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are evaluating two strategies for complete revascularization in patients with acute myocardial infarction MI specifically ST-segment elevation MI STEMI or non-ST-segment elevation MI NSTEMI who also have multivessel coronary artery disease CAD and have undergone successful treatment of the culprit lesion with Percutaneous Coronary Intervention PCI. The study aims to compare physiology-guided complete revascularization to angiography-guided complete revascularization, focusing on both efficacy and safety outcomes. Participants are randomly assigned to one of two groups. One group receives physiology-guided PCI where the function of non-culprit lesions NCLs is assessed using resting full-cycle ratio RFR or fractional flow reserve FFR, with PCI performed on lesions meeting specific thresholds. The other group undergoes angiography-guided PCI, receiving routine staged PCI on all qualifying NCLs identified before randomization. Both approaches follow local practice standards for PCI. During the study, researchers monitor participants for a minimum of two years to assess the time to first occurrence of major cardiovascular events, including cardiovascular death, new MI, or ischemia-driven revascularization, as well as safety outcomes like significant bleeding, stroke, stent thrombosis, or kidney injury related to contrast use. The trial also includes an observational imaging study using optical coherence tomography in a subset of patients. Follow-up assessments will enable evaluation of both efficacy and safety over the study period.