ANBL12P1: Pilot Study Using Myeloablative Busulfan/Melphalan (BuMel) Consolidation Following Induction Chemotherapy for Patients with Newly Diagnosed High-Risk Neuroblastoma

Date Added
July 17th, 2013
PRO Number
Pro00026760
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

the United States, it is standard treatment for patients with high-risk neuroblastoma (NBL) to receive the drugs carboplatin, etoposide and melphalan (CEM) as the preparative regimen in Consolidation therapy prior to Autologous Stem Cell Transplant (ASCT). BuMel Consolidation therapy has recently been studied in patients with high-risk NBL in some European countries. The findings from those studies indicate that the use of BuMel prior to ASCT may be linked to an increase in the survival rate for patients when compared to CEM. Those studies also indicate that the chance of the disease coming back (a relapse) may be lower among the patients who received BuMel Consolidation therapy. In North America the BuMel combination is considered experimental. In this study, researchers want to find out if a combination of busulfan and melphalan (BuMel) can be given as Consolidation therapy prior to ASCT for subjects with newly diagnosed high-risk NBL. The main goal of this study is to find out what effects, good and/or bad, a BuMel preparative regimen given before ASCT has on people with newly diagnosed high-risk NBL.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

Comparative Effectiveness of Pulmonary Embolism Prevention after Hip and Knee Replacement: Balancing Safety and Effectiveness

Date Added
April 19th, 2016
PRO Number
Pro00053742
Researcher
Vincent Pellegrini

List of Studies


Keywords
Drug Studies, Joint
Summary

PEPPER is a randomized study comparing the three most commonly used blood thinners in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The blood thinners being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@gmail.com

Multicenter Phenotype-Genotype Analysis of Vascular Anomalies and Related Syndromes

Date Added
December 24th, 2021
PRO Number
Pro00116848
Researcher
Lara Wine Lee

List of Studies


Keywords
Genetics, Pediatrics, Skin, Vascular
Summary

The purpose of this research study is to develop a better understanding of the cause and natural history of vascular anomalies and related syndromes. This study is being done in order to develop a better understanding of the cause of vascular anomalies in order to to improve care for people who are affected by these anomalies and related syndromes.

This study is being done at the University of Wisconsin-Madison (UW-Madison) and other sites in North America and Europe. A total of about 1000 people will participate in this study. About 20 – 30 people will take part in the study here at the Medical University of South Carolina.

Institution
MUSC
Recruitment Contact
Chelsea Shope
8437549577
shopec@musc.edu

CorEvitas Inflammatory Bowel Disease (IBD) Drug Safety and Effectiveness Registry

Date Added
June 8th, 2022
PRO Number
Pro00120887
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease, Digestive System, Non-interventional
Summary

This is a prospective, observational research study for patients with IBD under the care of a gastroenterologist provider. The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD.The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD .Approximately 10,000 patients and 150 clinical sites in North America will be recruited to participate with no defined upper limit for either target. The Corrona IBD Registry is a long-term observational study; therefore, the duration of the registry has no pre-determined stop date.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-1221
recruitment@musc.edu

CorEvitas Inflammatory Bowel Disease (IBD) Drug Safety and Effectiveness Registry

Date Added
June 8th, 2022
PRO Number
Pro00120887
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease, Digestive System, Non-interventional
Summary

This is a prospective, observational research study for patients with IBD under the care of a gastroenterologist provider. The objective of the Corrona Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD.The diseases under study include Crohn's Disease (CD), Ulcerative Colitis (UC) and Indeterminate Colitis (IC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD .Approximately 10,000 patients and 150 clinical sites in North America will be recruited to participate with no defined upper limit for either target. The Corrona IBD Registry is a long-term observational study; therefore, the duration of the registry has no pre-determined stop date.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Zerlinna Teague
(843) 792-1221
recruitment@musc.edu

SPOTLITE: ProSPective ObservaTionaL Study on the Clinical Outcomes of Surgical InTErventions in Complex Fistulizing Conditions (CPF-CD, CD-RVF, CCF)

Date Added
October 3rd, 2023
PRO Number
Pro00129787
Researcher
Erin Forster

List of Studies


Keywords
Crohn's Disease
Summary

This is a prospective, multicenter, observational study in an international setting (North America, Europe, and Israel) to follow clinical outcomes for patients with complex fistulizing conditions for 24 months after undergoing surgical intervention to treat the index fistula. During participation, standardized data on exposure and outcomes (clinical, patient reported outcomes (PROs), and Healthcare Resource Utilization (HCRU)) will be collected from electronic data capture forms (EDCs). Following the surgical intervention for the fistulizing condition (index date), outcomes will be assessed at 3 months, 6 months, 12 months, and 24 months post-surgery (post-index).

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease (CIRCULATE-NORTH AMERICA)

Date Added
October 21st, 2024
PRO Number
Pro00138258
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to determine what kind of chemotherapy to recommend to patients based on the presence or absence of circulating tumor DNA (ctDNA) after surgery for colon cancer? ctDNA, or circulating tumor DNA, is DNA that has been released from tumor cells into your bloodstream. This DNA can be measured using a blood test.

This study seeks to find if this approach is better or worse than standard of care for colon cancer.

Treatment and follow up for this study may be up to 8 years. The procedures include blood samples, tissue samples, and chemotherapy. Risks include diarrhea, nausea, vomiting, hair loss, mouth sores, loss of appetite, tingling or pain in hands/feet/arms/legs, and anemia. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis

Date Added
February 12th, 2025
PRO Number
Pro00142401
Researcher
Lauren Sullivan

List of Studies

Keywords
Nontuberculous mycobacteria (NTM)
Summary

This trial is a study to evaluate the efficacy and safety of ensifentrine inhalation suspension administered via nebulization (3 mg BID) compared to placebo in subjects with non-cystic fibrosis bronchiectasis (NCFBE). Approximately 180 eligible subjects meeting all inclusion and no exclusion criteria will participate at approximately 45 sites in North America, the United Kingdom, and the European Union. Only subjects completing the Screening Period, meeting all inclusion, meeting no exclusion criteria, and meeting none of the randomization exclusion criteria will be randomized to receive blinded study medication: ensifentrine or placebo. The study has 3 periods: a Screening Period (up to 4 weeks, or 28 days), a Study Treatment Period (24 weeks or longer), and a Follow-up Period (4 to 10 days after your last dose of the study drug).

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

J2T-MC-B002 (ADjoy): A Prospective Observational Cohort Study Evaluating Lebrikizumab Therapy in the Management of Adult and Pediatric Participants 12 Years of Age and Older with Moderate-to-Severe Atopic Dermatitis in North America

Date Added
July 16th, 2025
PRO Number
Pro00142075
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

J2T-MC-B002 (B002) examines the effectiveness of lebrikizumab in treating moderate-to-severe atopic dermatitis (AD). This study involves adult and adolescent patients suffering from eczema, which is characterized by inflammation, redness, and irritation of the skin. Participants will complete symptom assessments during their visits and will schedule appointments within specific timeframes. The study will also observe skin lesions using clinical measures. Participants will remain in the study for up to two years, even if their therapies change, to track disease progression with or without lebrikizumab. This observational study aims to record real-world treatment outcomes for the analysis of lebrikizumab in AD therapy.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
8438760110
yeadon@musc.edu



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