Cartersville

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 evaluating the safety and performance of a new prostate biopsy system using the SUREcore biopsy needle and coreCARE specimen retrieval device. This study compares these devices to the standard biopsy needle and tissue container typically used in urology offices. The goal is to see if the new system can obtain better quality prostate tissue samples for pathological review, as current devices often collect fragmented or disrupted tissue. Participants will undergo prostate tissue biopsy following a 12-core systematic template. Six samples will be taken with the standard biopsy needle, and six with the SUREcore needle. The tissue samples will then be randomly assigned to be retrieved either by the swiping method or the coreCARE device. The study also includes user rankings of the biopsy tools during the procedure and a pathologist's assessment of tissue quality. During the study, adverse events will be monitored during the procedure and for five days afterward. Participants will be asked for their verbal assessment of their condition five days post-procedure. Researchers will measure outcomes such as procedure success, the length and weight of tissue cores obtained, and tissue sample preparation quality, all evaluated one day after the procedure.

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 the safety and effectiveness of a combination drug called VNX001 compared to placebo and its individual components, lidocaine hydrochloride and heparin sodium, in adults with interstitial cystitis (IC) or bladder pain syndrome (BPS) who experience acute bladder pain of moderate to severe intensity. This Phase 2, randomized, double-blind, placebo-controlled, multi-center study aims to reduce bladder pain during such episodes. The study plans to enroll up to 180 subjects across about 12 sites in the United States. Participants will receive a single dose of either VNX001, placebo, alkalinized lidocaine, or alkalinized heparin by random assignment in a 3:1:3:1 ratio. After 24 to 48 hours post-dose, all subjects may choose to receive an optional single dose of VNX001. The treatments are given once per participant, and the study compares the combination product to its individual components and placebo. Throughout the study, participants will be monitored for bladder pain intensity, with the main outcome measured as the sum of bladder pain intensity differences from baseline to 12 hours after dosing. Assessments include pain scores and safety evaluations. The total participation involves screening, a single-dose treatment period, optional dosing 1 to 2 days later, and follow-up to assess safety and pain reduction.

Researchers are evaluating the safety, effectiveness, and frequency of dosing of VNX001 in adults with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) experiencing acute moderate to severe bladder pain. This phase 2b, open-label study focuses on how often VNX001 can be given as needed over a 14-day period and includes participants who have had IC/BPS for at least 9 months. The study aims to count the number of doses used and measure pain levels before and after treatment, while also assessing safety and tolerability of the drug. Participants will receive up to six doses of VNX001 administered directly into the bladder through a catheter as needed during the 14-day study. The study includes up to seven clinic visits, which may involve one combined screening and dosing visit plus additional dosing visits. There will also be five telephone visits for follow-up and monitoring during the study period. Participants will use a diary or phone calls daily to record bladder pain, urinary urgency, any side effects, and medications taken. Throughout the study, participants will be closely monitored with assessments of bladder pain intensity and frequency of dosing. Researchers will track safety and tolerability while collecting data on symptoms and medication use. The study involves a total participation duration of 14 days, with multiple opportunities to evaluate the effects of VNX001 both in the clinic and remotely.