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Funding: NIDDK
Investigator: Lewis, J

The URBI study is a multicenter parallel group clinical trial. The primary objective is to determine if high-definition white light colonoscopy (HDWLC) using a limited biopsy strategy is non-inferior to HDWLC with a random 4x10cm biopsy strategy to detect dysplasia or sessile serrated adenoma (SSA) in patients with inflammatory bowel disease (IBD). Additional objectives of the study are to determine if HDWLC with a limited biopsy strategy is superior to HDWLC with a random 4x10cm biopsy strategy to detect one or more dysplastic or SSA lesion in patients with IBD, determine whether the number of targeted biopsies differs based on the number of random biopsies obtained and to define the molecular characteristics of the progression of colitis-associated dysplasia.

The URBI study started in July 2024. The CRCU supports the study with project management and data management services.

Clinical trials.gov NCT06560021

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Funding:  Patient-Centered Outcomes Research Institute (PCORI)
Investigator:  Neuman, MD

Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions - My Anesthesia Choice (MAC) is an implementation study to improve pre-anesthesia care discussions between care providers and patients who are undergoing hip replacement surgery.  The objective of this research study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication.

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Study timeline:       8/10/2023-7/31/2028
Investigators:         Barnhart, K; Schisterman, E
Funding:                  Eunice Kennedy Shriver National Institute of Child Health and Human Development

This is a parallel assignment, randomized, double blind clinical trial of double low-dose aspirin (162 mg/day) begun no later than 6 weeks 6 days gestation, through delivery, to investigate the effects of early initiation of prophylactic aspirin therapy compared to standard of care (placebo through 12 weeks’ gestation, 81 mg aspirin thereafter through delivery) on reducing risk of both pregnancy loss and preeclampsia in pregnant people with one or more risk factors.

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Study timeline: 9/1/2023-5/31/2030
Funding: National Institutes of Health (NIH)
Investigator: Mumford, S

The ECHO Study is a National Institutes of Health (NIH) funded longitudinal study to seek the impact of broad range early environmental influences on child development and health.  In 2016, the NIH established the Environmental influences on Child Health Outcomes (ECHO) Program, an innovative and collaborative research initiative whose mission is to enhance the health of children for generations to come. The overarching scientific goal of ECHO is to advance understanding of the effects of a broad array of early environmental exposures on children’s development and health outcomes with high public health impact.

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Kyle R. Jackson, MD, PhD

Kyle R. Jackson, MD PhD is an Assistant Professor of Surgery at the University of Pennsylvania and a Senior Scholar at the Center for Clinical Epidemiology and Biostatistics. He is a clinically active transplant surgeon with a clinical practice focused on adult and pediatric kidney transplantation, pancreas transplantation, and laparoscopic kidney donation. His primary research interest is in characterizing the impact of climate change and environmental pollutants on human health, with a particular focus on healthcare utilization and disease burden. His clinical practice has also led to a special interest in understanding how these environmental factors impact transplant patients, who are uniquely susceptible to these effects due to the profound immunomodulation necessary to facilitate successful transplantation as well as highly prevalent place-based vulnerabilities. He also uses national registry and claims-based datasets to solve clinically relevant problems in solid organ transplantation - such as identifying optimal transplant strategies for the immunologically high-risk, quantifying and improving equity and access to organ transplantation, and characterizing the clinical and financial impact of post-transplant complications. Dr. Jackson has received direct research support as a Principal Investigator from both foundational and federal sources, such as the NIH/NIDDK and the Doris Duke Foundation.

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Veeva Vault: an FDA 21 CFR Part 11 compliant clinical data management tool used to manage projects requiring FDA oversight, such as trials of an Investigational New Drug (IND) or New Drug Applications (NDA). 

Access to our current list of Veeva Vault projects.

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Funding: NIH/NIDDK
Investigator(s): Dember, LM; Flythe, JE; Crews, D

The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches...

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Funding: PCORI
Co-Principal Investigator(s):  Flythe, JE; Dember, LM

The SMaRRT-HD Study, also known as “Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis” compares two approaches for monitoring and addressing symptoms among adult patients with kidney failure who are treated with hemodialysis.

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Funding: NCI
Investigator(s): Mason, N; Long, Q

The mission of the Pre-medical Cancer Immunotherapy Network for Canine Trials (PRECINCT), supported by grants from the National Cancer Institute, is to provide infrastructure and oversight to a highly collaborative and interactive network of researchers and clinician scientists working to accelerate the application of next generation immunotherapies through comparative oncology. Pet dogs spontaneously develop cancers that share remarkable similarities in biology, genetics, treatment response and outcome to human patients. Evaluating next generation immunotherapies and combination immunotherapies in immune competent canine patients aims not only to provide more effective treatments for these pets but also unparalleled insight into response and response prediction through correlative biomarker discovery. This work will aid human clinical trial design and accelerate the translation of novel immunotherapies and immunotherapy protocols into the human clinic.

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