Carrollton

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

Researchers are conducting an international, multicenter, observational, non-interventional, prospective, blinded, single-arm study to evaluate the performance of the Cordio HearO system in patients with symptomatic chronic heart failure. The study aims to collect and analyze patient utterances to determine the sensitivity and usable positive negative rate (UPNR) of the HearO system. Participants include adults aged 22 and older diagnosed with symptomatic chronic heart failure classified as NYHA II-IVa who meet specific clinical criteria. The study consists of two periods: a Run-In period during which patients submit daily voice recordings to establish a baseline, followed by a Core period where patients continue daily recordings for up to 24 months or until the end of the study. The HearO app is used solely for data collection without any intervention or treatment changes. The study is designed for continuous remote monitoring through the app. Participants will be involved in daily submission of voice recordings throughout the study duration. Researchers will assess heart failure events, defined as first usable and adjudicated heart failure events, with a total of at least 78 events or a maximum of 24 months per patient marking the end of the study. Safety and clinical stability will be monitored by investigators, and patient consent is required before participation.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Researchers are evaluating a brief talk therapy treatment called Prolonged Exposure for Primary Care (PE-PC) to reduce post-traumatic stress disorder (PTSD) symptoms in First Responders and Healthcare workers. The study compares this treatment to usual care provided by Employee Assistance Programs (EAPs), aiming to see if PE-PC can improve PTSD symptoms and overall functioning more effectively. Participants will receive either PE-PC or EAP Treatment as Usual (TAU). PE-PC involves 4 to 6 weekly sessions of 30 minutes each, delivered either in person or via telehealth, focusing on the most effective components of prolonged exposure therapy. TAU consists of up to six sessions of solution-focused therapy and referrals to specialized PTSD care, delivered according to each EAP's usual practice. Both groups complete surveys and homework during and after treatment. During the study, participants will be assessed for PTSD symptoms using standardized checklists from the start until six months later. Researchers will monitor all care received during the study, including therapy attendance and medication use. Safety evaluations will include checking for cognitive impairment and suicide risk. The total participation time covers treatment and follow-up assessments to measure changes in PTSD symptoms over six months.