Queen Creek

Researchers are studying UGN-104, a new formulation of UGN-101 also known as JELMYTO, to evaluate its effectiveness and safety in treating patients with low-grade upper tract urothelial cancer LG-UTUC. This phase 3, single-arm study focuses on patients with this specific type of cancer affecting the upper urinary tract, aiming to assess how well the treatment works and its safety profile. Participants will receive UGN-104 once a week for six weeks, with each dose administered directly into the upper urinary tract via a ureteral catheter or nephrostomy tube. The dose consists of 4 mg mitomycin per 1 mL sterile hydrogel. After the initial treatment period, patients who have no detectable disease at the primary disease evaluation visit about three months after the first dose may enter a follow-up phase where they could receive monthly maintenance doses for up to 11 months, depending on the investigators decision. During the study, participants will have evaluations every three months to check for disease response or recurrence. These assessments include urine cytology, visual inspection via ureteroscopy, and biopsies if needed. Researchers will monitor the complete response rate at three months as the primary outcome and track the duration of response, durable complete response rate, and any treatment-related side effects for up to 15 months. The total participation time varies depending on response and disease status.

Researchers are evaluating the safety and effectiveness of intravesical T3011 injection in adults with high-risk non-muscle invasive bladder cancer NMIBC that has not responded to BCG treatment or chemotherapy. This Phase II study includes participants with different types of NMIBC, such as carcinoma in situ CIS and papillary tumors, who have either failed BCG therapy or chemotherapy after BCG exposure. Participants receive T3011 treatment directly into the bladder once a week for six weeks during the induction phase. Based on their response at three months, some may receive a reinduction course. Those who show complete response or no recurrence enter a maintenance phase with T3011 administered every three weeks for up to about 24 months. Disease status is regularly monitored through cystoscopy, urine cytology, histopathology, and imaging every three months during treatment or until recurrence. Throughout the study, participants undergo assessments including tumor evaluations and safety monitoring for treatment-related side effects. The primary outcomes measured include complete response rates, recurrence-free survival at various time points, and the incidence of significant treatment-related adverse events over 24 months. Participants are followed closely to assess both effectiveness and safety of the treatment during the entire study period.

Researchers are evaluating the effectiveness of an AI-based treatment strategy using a Chatbot, Copilot, large language models, and vital sign monitoring devices to reduce the burden of Cardio Kidney Metabolic CKM diseases. This study focuses on patients with interconnected conditions including diabetes, heart disease, and kidney disease, which have significant health and economic impacts. The trial aims to use an algorithm derived from biomarkers and diagnostics combined with remote sensor technology and patient empowerment to improve health outcomes in this population. Participants will be assigned randomly to either an intervention group receiving the CHAPERONE AI treatment or a control group. The intervention uses machine learning-based Chatbot and Copilot tools along with algorithms informed by biomarkers and diagnostics to manage CKM diseases. The study will assess outcomes at 30, 90, and 180 days, including reduction in kidney failure progression, heart failure events, acute myocardial infarction, diabetes complications, hospitalizations, and mortality. Additional tools such as the CKMiq AI device will be used to monitor cardiovascular readmissions and patient well-being through established scoring systems. During the trial, participants will undergo assessments of their health status, including biomarker analysis, diagnostic tests, and quality of life surveys like the SF-12. Researchers will monitor composite outcomes related to kidney and heart disease progression and hospital readmissions. Data will be collected at multiple time points to evaluate the impact of the AI-driven intervention on disease management and patient empowerment over six months. Safety and health status will be followed up for the duration of participation, which begins at enrollment and continues through 180 days.

Researchers are evaluating the drug TARA-002 for treating high-grade non-muscle invasive bladder cancer NMIBC in adults aged 18 years and older who have not previously received BCG therapy. The main goals are to determine if TARA-002 can help treat this cancer type, assess its safety, and identify any side effects. The study compares TARA-002 with investigators choice of intravesical chemotherapy to see how well each treatment works. Participants will be randomly assigned to receive either TARA-002 or an intravesical chemotherapy selected by their investigator. Those receiving TARA-002 will get six weekly doses initially, with the possibility of additional maintenance and reinduction treatments based on their response at weeks 12 and 24. Participants in the chemotherapy group will receive six weekly doses followed by monthly maintenance doses up to month 25. These treatments are administered directly into the bladder. During the study, participants undergo regular assessments to measure cancer response, including the rate of complete response at six months and ongoing evaluations up to five years. Researchers will monitor treatment-related side effects and track survival outcomes, recurrence, progression, and time to bladder removal surgery. The study lasts until November 2032, with primary outcomes measured at six months and extended follow-up continuing for up to 60 months.

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 studying the safety and effectiveness of TARA-002, a biological preparation containing Streptococcus pyogenes cells, for adults aged 18 and older with high-grade non-muscle invasive bladder cancer NMIBC, including carcinoma in situ CIS with or without TaT1 tumors. This Phase 2 open-label trial further evaluates TARA-002 at a dose established in an earlier Phase 1a study. Participants include those with active disease confirmed within 3 months before enrollment, divided into two groups based on prior treatment with BCG therapy. Participants receive TARA-002 directly into the bladder through instillation. The treatment involves an initial period of six weekly doses, followed by a possible second period of six additional weekly doses or three weekly maintenance doses for those with a complete response. Maintenance doses continue at specified months up to 24 months. After treatment, participants enter a follow-up period lasting from month 27 to month 60 to monitor long-term outcomes. Throughout the study, participants undergo regular assessments including evaluations of tumor response, progression-free survival, overall survival, and quality of life using specific questionnaires. Researchers monitor urinary biomarkers and track adverse events from the first day of treatment through the entire follow-up period. The studys main outcome is the rate of high-grade complete response measured from 3 to 60 months after treatment. Total participation may last up to 5 years.