Carrollton

Researchers are evaluating disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

Researchers are conducting an international, multicenter, observational study to assess the performance of the Cordio HearO system in patients with symptomatic chronic heart failure. This non-interventional, prospective, single-arm study aims to collect patient voice recordings to analyze the sensitivity and unique patient noise reduction UPNR capabilities of the HearO device. The study is sponsored by Cordio Medical and focuses on monitoring heart failure events over time. The study consists of two periods a Run-In period where patients submit daily recordings to establish a baseline, followed by a Core period where patients continue daily submissions for up to 24 months or until the study ends. There is no active treatment or intervention beyond data collection using the HearO app, which records patient utterances for later analysis. Participants will submit daily voice recordings throughout the study duration. Researchers will monitor heart failure events, defined as first usable and adjudicated heart failure events, as the primary outcome. The study involves regular data collection without additional interventions, focusing on patient adherence to daily use of the app. The total observation period per participant may last up to 24 months or until a predefined number of heart failure events have occurred.

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 the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.

This research aims to evaluate a brief PTSD treatment called Prolonged Exposure for Primary Care PE-PC among First Responders and Healthcare workers. The study compares this approach to standard care provided by Employee Assistance Programs EAPs to see if it reduces PTSD symptoms and improves functioning. The trial is sponsored by the University of Michigan and focuses on those with significant PTSD symptoms. Participants receive either the PE-PC treatment, which consists of 4 to 6 weekly 30-minute sessions delivered in person or by telehealth, or the usual EAP Treatment as Usual TAU which typically includes up to six solution-focused therapy sessions and referrals for specialized PTSD care. Both treatments involve homework and surveys, with progress reviewed at the end of the PE-PC sessions. The TAU groups care is monitored throughout the study, including outside treatments and medication use. Throughout the study, participants complete various surveys and homework assignments to track changes in PTSD symptoms, burnout, job performance, depressive symptoms, and patient satisfaction over six months. The main outcome measured is the change in PTSD symptom severity from baseline to six months. The study uses a randomized design and collects detailed monitoring data on treatment adherence and outcomes during this period.