Search Results Within Category "Kidney & Urinary System"

A randomized placebo-controlled study to evaluate the efficacy and safety of VIB4920 in study participants with active lupus nephritis

Patients come for in-person visits at the Penn State Hershey main hospital location. There will be blood draws, physical exams, and questionnaires spread out across 60 weeks.

The study is being done to determine whether dalcinrenone/dapagliflozin is superior to dapagliflozin in reducing the risk of cardiovascular death and heart failure events with and without hospitalization

Sign consent form, attend scheduled study visits, undergo an echocardiogram (if applicable) and electrocardiogram, complete pregnancy test (if applicable), undergo physical examination, vital signs, height and weight measurements, complete study questionnaires, provide urine and blood samples for the study, take study medication as directed.

up to $1,600

Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease. This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.

There are 4 stages to this study: screening phase, induction study treatment phase, maintenance study treatment phase and long-term follow-up phase. In screening you can expect to be asked questions about your medical history, MRI or CTU, blood and urine samples, physical exam, vitals, tumor assessment by ureteroscopy and biopsy under anesthesia. Induction Treatment Phase (1-3 months) • Participants undergo anesthesia and receive the study therapy 1 to 3 times, about 4 weeks apart. If a participant does not achieve Complete Response (CR)* after 3 treatments (or if their disease has progressed as defined in the protocol), the participant will be discontinued from the Treatment Phases and enter the Long-term Follow-up Phase. Maintenance Treatment Phase (12 months) • Participants who achieve CR* from Induction Treatment Phase will be followed for 12 months. Up to 3 repeated study therapy doses will be provided for participants who have treatable tumor recurrence as determined by the study doctor. Long-term Follow-up Phase (48 months) • Patients who achieve CR and then enter the maintenance treatment phase and who have a CR after the end of maintenance treatment phase will enter the Long-term Follow-up Phase and will be followed up for up to an additional 48 months in the Long-term Follow-up Phase or until recurrence, progression, death or loss to follow up, to document safety and ongoing response. • Patients discontinued from the treatment phases and who have received at least one study treatment will be followed up for additional 12 months in the long-term follow-up phase of the study from last VTP treatment.

The purpose of this study is to find out if an implant of ACT is safe and effective in reducing urinary incontinence. The study will involve about 132 women that have urinary incontinence. This system is investigational. After placement of the devices, participants will be followed for 12 months on a regular visit schedule. Annual visits may continue for up to 5 year. ACT® is an implantable device for treating stress urinary incontinence. One end of the device is a balloon that is attached by a tube to a port at the other end of the device.

Participants will attend a screening visit, the implantation visit, post-op assessment, 6 week, 3 month, 6 month, 12 month, and annual follow up visits for necessary device adjustments.

600

The purpose of this Expanded Access Program is to determine the safety of cretostimogene in patients with BCG -unresponsive high-risk Non Muscle Invasive Bladder Cancer and to determine the Complete Response rate at any time of cretostimogene in patients with BCG-unresponsive CIS with or without HG Ta/T1 papillary NMIBC

Eligible participants will receive the study drug, Cretostimogene every week for 6 treatments, followed by a maintenance period as directed by the Investigator. There are 3 phases in the study: Screening Phase, Treatment Phase, and Follow-Up Phase. The Screening Phase will last up to 16 weeks (4 months). The Treatment Phase can continue for up to 2 years from the start of study treatment unless your cancer gets worse or recurs. The Follow-Up Phase will include one visit every 3 months after the last study treatment. If your cancer has not come back but you stop treatment before the end of the Treatment Phase, you will also have a study visit every 3 months in the Follow-Up Phase to confirm whether your cancer gets worse or recurs, until 2 years after the start of treatment. If your cancer has gotten worse or recurs at any point during the study, you will not be scheduled to return to the clinic/hospital for the study after the final visit, but you will be contacted approximately every 6 months.