Cartersville

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 evaluating the performance and safety of the SUREcore biopsy needle and the coreCARE specimen retrieval device compared to a standard biopsy needle and tissue container in men undergoing prostate biopsy. The study aims to assess whether these new devices improve the quality and completeness of prostate tissue samples, which are often fragmented with current biopsy tools. This post-market study is sponsored by Uro-1 Medical and involves men diagnosed with prostate disease or prostate cancer. Participants will undergo prostate tissue biopsy following a 12-core systematic template. Six samples will be collected using the standard biopsy needle and six with the SUREcore needle. The tissue samples will then be randomly retrieved either by the swiping method or using the coreCARE device. The study compares the amount and quality of tissue collected with each method, and users will rate the ease of use of the biopsy tools during the procedure. During and up to five days after the biopsy procedure, researchers will monitor for any adverse events. Pathologists will evaluate the quality of the tissue cores obtained, and users will provide feedback on the biopsy devices. Primary outcomes measured include procedure success, core tissue length, tissue weight, and tissue sample preparation, all assessed on the day of the procedure. Participants will also be asked to verbally assess their condition five days following the biopsy.

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.

Researchers are evaluating the safety and effectiveness of a combination drug called VNX001 compared to placebo and its individual components, lidocaine hydrochloride and heparin sodium, in people with interstitial cystitisbladder pain syndrome ICBPS who are experiencing an episode of moderate to severe bladder pain. This Phase 2, multi-center, randomized, double-blind, placebo-controlled study aims to better understand how these treatments reduce bladder pain during acute episodes. Participants will be randomly assigned to receive a single dose of VNX001, placebo alkalinized phosphate buffer, alkalinized lidocaine, or alkalinized heparin. The treatments are administered through intravesical instillation directly into the bladder. After 24 to 48 hours, all participants have the option to receive a single open-label dose of VNX001. The randomization ratio is 3131 for VNX001, placebo, lidocaine, and heparin respectively. Throughout the study, participants will have their bladder pain intensity measured at various time points up to 24 hours after dosing using pain scales and questionnaires. Researchers will also monitor the use of the optional open-label VNX001 dose at 48 hours and track any adverse events for 72 hours. The total involvement includes screening, a single treatment visit, and follow-up assessments to evaluate pain relief and safety.

Researchers are evaluating the safety, effectiveness, and dosing frequency of VNX001 in people with Interstitial CystitisBladder Pain Syndrome ICBPS, a condition causing moderate to severe bladder pain. This Phase 2b, open-label study focuses on treating acute episodes of bladder pain and aims to count the number of doses used and measure pain levels before and after treatment. The research also monitors how well participants tolerate VNX001 and any side effects. Participants will receive up to six doses of VNX001 administered directly into the bladder through a catheter over a 14-day period. Each dose contains 15 mL of buffered lidocaine HCl and sodium heparin. The study includes up to seven clinic visits, which cover screening and dosing appointments, or at least one combined screening and dosing visit plus five telephone calls. The dosing is given as needed based on pain episodes. During the study, participants will record their bladder pain, urinary urgency, side effects, and any medications taken daily via a diary or telephone calls. Researchers will assess pain changes at multiple time points after dosing and track overall symptom improvement. Safety is monitored through adverse event reporting up to 17 days. The study lasts 14 days, during which participants will have frequent contact with the clinic for evaluations and support.