A Phase 3, Randomized, Open-label, Multi-center Study Evaluating the Efficacy and Safety of TAR-200 Versus Investigator's Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred with High-risk Non-muscle-invasive Bladder Cancer (HR-NMIBC) and Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy SunRISe-5

Date Added
October 22nd, 2024
PRO Number
Pro00138690
Researcher
Paul Womble

List of Studies


Keywords
Bladder, Cancer, Urinary
Summary

This is a VA study only and will not be put on the SC Research web page.

This study is for subjects with bladder cancer after being treated with BCG and the cancer is currently considered high risk, but not yet reached the bladder muscle. This study is for people who do not qualify for additional BCG treatment or do not want to have their bladder removed. The next line of medication for standard of care treatments with this population are instillations into the bladder with drugs called mitomycin-C or gemcitabine. This study will use a drug delivery system called TAR-200 that slowly releases gemcitabine over 3 weeks. This will be compared to subjects who receive standard of care instillations. Subjects will be randomly assigned (flip of a coin) to either receive standard of care therapy or the study device. The treatment phase will last up to 2 years and the overall study will last up to 5 years.

Institution
MUSC
Recruitment Contact
Elina Bolukbasi
843-789-7816
Elina.Bolukbasi@va.gov

Pediatrics Biorepository for Nephrology Clinical Research

Date Added
April 20th, 2023
PRO Number
Pro00124386
Researcher
Katherine Twombley

List of Studies


Keywords
Bladder, Children's Health, Kidney, Urinary
Summary

The goal of this study is to develop a biorepository to store pediatric biospecimens from nephrology cohorts for on-going and future research studies. These studies plan to advance the state of science in the hopes to find more information that potentially leads to developing novel diagnostic approaches and identify therapeutic targets to prevent and/or treat pediatric disease involving the kidneys.

Institution
MUSC
Recruitment Contact
Katherine Twombley
843-792-8904
twombley@musc.edu

Intrathecal Morphine versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial

Date Added
June 21st, 2022
PRO Number
Pro00121082
Researcher
Natalie Barnett

List of Studies

Keywords
Adolescents, Kidney, Pediatrics, Urinary
Summary

Patients between the ages of 12 months and 11 years who are undergoing lower abdominal laparotomy will be randomized to receive intrathecal morphine, or bilateral quadratrus lumborum block. We will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.

Institution
MUSC
Recruitment Contact
Haley Nitchie
843-792-1869
nitchie@musc.edu

The POSEIDON Kidney Disease Registry and Biobank

Date Added
September 18th, 2012
PRO Number
Pro00019764
Researcher
Joshua Lipschutz

List of Studies


Keywords
Kidney, Rare Diseases, Transplant, Urinary
Summary

Currently, kidney disease affects up to 20% of the US population and is a strong contributor to morbidity and mortality in these patients. Specific therapies and diagnostic tools for kidney disease have been very slow to develop because of the absence of high quality samples and data that can be used for research studies. The purpose of this study is to develop a registry and sample bank called Poseidon (Prevention, Optimizing Safety, Early Intervention and DetectiOn in Nephrology) biobank that can be used for future research. In this study, patients can consent to donating their residual kidney tissue if they undergo a kidney biopsy and blood or urine during routine clinical care procedures. We will also collect blood and urine outside of clinical care.This study will allow biomedical research the ability to obtain specimens from patients with relevant diseases and appropriate clinical data. This study will collect patient demographic, clinical and historical data for a registry and patient samples will be deposited in the Poseidon biobank. Patients do not have to be diagnosed with Kidney Disease to be included in this study.

Institution
MUSC
Recruitment Contact
Linda Walker
8437926109
walkerlp@musc.edu

OUTCOMES OF PATIENTS WITH AUTOLOGUS MID-URETHRAL SLING AFTER FAILURE OF MID-URETHRAL MESH SLING

Date Added
June 29th, 2012
PRO Number
Pro00012059
Researcher
Eric Rovner

List of Studies


Keywords
Urinary
Summary

Mid-urethral slings have been widely accepted as a treatment of choice for patients with stress urinary incontinence (SUI). Mid-Urethral sling surgery has been associated with good success rate and minimal morbidity.Minor complications are associated with these surgeries including bladder perforation, urethral injury or post operative complication such as de novo urgency and urge urinary incontinence, urinary retention or incomplete bladder emptying. Treatment approaches for complications included sling excision and urethral/bladder/ vaginal defect repair after sling intrusion or extrusion into these organs. Treatments for postoperative voiding dysfunction include clean intermittent catheterization, mid-urethral sling lysis, sling incision and formal urethrolysis. With urethrolysis, obstruction has been reported to be relieved in 65% to 93 with preservation of continence in 80% to 100% while the rate of SUI postoperative is 0 % to 19%.autologus fascial sling for relieve of obstruction with 54% of patients had no recurrence of their SUI [25]. On the other hand, there have been no published data on the use of autologus fascia lata pubovaginal sling to treat patient with recurrent SUI after incision of the mid-urethral mish slings. Urethral injection of bulking agent have been reported with 34% cure [26] and re-do mid urethral sling was reported to have only 53% success over 17 months of follow-up [9].
Our aim is to evaluate the subjective and objective outcomes of salvage treatment of failed mid-urethral mesh sling with sling incision, urethrolysis, autologus facial pubovaginal sling or other forms of diversion if needed. We also will evaluate if this procedure will help to improve in the quality of life of these patients.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
ude.csum@njiknej



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