A Phase 3 Study of 131I-Metaiodobenzylguanidine (131I-MIBG) or Crizotinib Added to Intensive Therapy for Children with Newly Diagnosed High-Risk Neuroblastoma (NBL) (IND# 134379) Save

Date Added
October 8th, 2018
PRO Number
Pro00082422
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients who have been diagnosed with a neuroblastoma (NBL). The purpose of this study is to find out if we can improve the treatment for subjects with high-risk NBL by adding the experimental drug 131I-MIBG or the experimental drug Crizotinib to recommended therapy. The secondary purpose is to find out if we can reduce the number of stem cell transplants from two to one if we give the experimental drug 131I-MIBG during Induction, and use different drugs as part of the transplant chemotherapy given prior to stem cell infusion during Consolidation. Participants can expect to be in this study for up to 2 years. Researchers would like to continue to follow participants health for up to 10 years.

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

A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors Save

Date Added
October 8th, 2018
PRO Number
Pro00082427
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Germ Cell Tumors. The purpose of this study is to evaluate whether a strategy of complete surgical resection followed by surveillance can maintain an overall survival rate of at least 95.7% at two years for pediatric, adolescent and adult patients (ages 0- 50 years) with Stage I (low risk) malignant germ cell tumors, and at least 98% for patients with ovarian pure immature teratoma. The drugs used in this study are carboplatin and cisplatin. Participants will be followed for up to 10 years.

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

Detecting the Pathophysiology that Drives Fontan-associated Liver Disease Save

Date Added
October 5th, 2018
PRO Number
Pro00077466
Researcher
Joshua Kurtz
Keywords
Adolescents, Cardiovascular, Children's Health
Summary

The purpose of this study is to evaluate causes and risk factors for liver disease in those whom have 1) undergone the Fontan procedure or 2) whom have dilated cardiomyopathy.

Participants in this study will have a blood sample collected, undergo cardiac magnetic resonance imaging (CMR), a liver magnetic resonance imaging (MRI), shear wave ultrasound elastography (SWE), echocardiography, liver Doppler ultrasound, and an exercise stress test. Participants medical records will be reviewed to collect information on previous medical procedures. Participation is complete once all imaging studies and blood sample have been collected.

This is not a treatment study; if one chooses not to participate, s/he will continue to undergo regularly scheduled clinical procedures.

Institution
MUSC
Recruitment Contact
Joshua Kurtz
843-834-0972
kurtzj@musc.edu

International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones Save

Date Added
October 3rd, 2018
PRO Number
Pro00082665
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients who have been diagnosed with a form of Acute Lymphoblastic Leukemia (ALL) called Philadelphia chromosome positive (Ph+) ALL. The purpose of this study is to compare disease free survival (DFS) of Standard Risk (SR) pediatric Ph+ ALL treated with continuous imatinib combined with either a high-risk COG ALL chemotherapy backbone or the more intensive EsPhALL chemotherapy backbone. A drug called imatinib in combination with chemotherapy will be given. Participants can expect to be in this study for up to 2 years and their health followed for up to 10 years.

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

Odor Disturbances: Clinical Care Registry Save

Date Added
September 26th, 2018
PRO Number
Pro00080333
Researcher
Thomas Uhde
Keywords
ADD/ADHD, Adolescents, Aging, Allergy, Alzheimers, Anxiety, Asthma, Autism, Autoimmune disease, Central Nervous System, Chronic Fatigue, Depression, Environmental Factors, Fibromyalgia, Inflammation, Memory Loss, Nervous System, Parkinsons, Psychiatry
Summary

Candidates for this study may or may not report disturbances in odor perception as their primary reason for seeking treatment at MUSC. This study is designed to collect long term, observational data from patients who are being treated with routine clinical care in health clinics at MUSC. Data from clinical questionnaires will be de-identified and stored in a database.

Institution
MUSC
Recruitment Contact
Richard Simmons
843-792-7439
simmr@musc.edu

Impact of Disparities in Food Security on Glycemic Control and Health Care Utilization Among Youth and Young Adults with Diabetes Save

Date Added
March 19th, 2018
PRO Number
Pro00075894
Researcher
Angela Liese
Keywords
Adolescents, Diabetes, Environmental Factors, Ethnicity and Disease, Nutrition
Summary

Many youth and young adults (YYAs) with type 1 diabetes (T1D) and type 2 diabetes (T2D), particularly those of minority race/ethnicity, do not achieve optimal glycemic control and household food insecurity (HFI) may be a key barrier. HFI is the limited or uncertain availability of nutritionally adequate and safe foods. The SEARCH Food Security (SFS) cohort study is designed as an ancillary study to the ongoing NIH/NIDDK-funded SEARCH for Diabetes in Youth 4 Cohort study. The aims of the SFS study are to (1) Initiate a food insecurity cohort study of 1,187 YYAs aged 15-35 years (53% minority) with T1D and T2D by adding two data collection time points to the ongoing SEARCH 4 study in three of the five SEARCH sites, including South Carolina, Colorado and Washington; (2) Evaluate how HFI influences changes in glycemic control in YYAs with T1D and T2D; (3) Identify the pathways through which food insecurity may act; and (4) Evaluate the influence of HFI on changes in health care utilization and medical and non-medical health care costs in YYAs with T1D and T2D.

Institution
Greenville
Recruitment Contact
Jessica Stucker
803-777-1961
jstucker@mailbox.sc.edu

Aneurysmal Subarachnoid Hemorrhage Trial RandOmizing Heparin Save

Date Added
September 26th, 2017
PRO Number
Pro00051279
Researcher
Alejandro Spiotta
Keywords
Adolescents, Brain, Drug Studies, Men's Health, Minorities, Obesity, Pain, Stroke, Women's Health
Summary

The purpose of this study is to determine if giving the medicine "heparin" intravenously (through the veins) continuously for up to 14 days to subjects after a brain aneurysm has burst will help improve the chances of subjects having a good recovery after the bleed compared to subjects who get routine brain aneurysm care (standard of care). Patients who get routine care would also get heparin, but they would typically get an overall lower dose and the heparin would be injected under the skin (heparin shot) instead of in the veins.

Institution
MUSC
Recruitment Contact
Amora Mayo-Perez
843-792-1737
mayoaper@musc.edu

Phase Ib/II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies Save

Date Added
August 22nd, 2017
PRO Number
Pro00066806
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Brain Tumor, Cancer, Cancer/Brain
Summary

This study is for patients that have been diagnosed with Central Nervous System (CNS) Tumors. The investigational drugs in this study are Nivolumab and Ipilimumab. The purpose of this study is to test the effectiveness, safety, and tolerability of Nivolumab when given alone or when combined with Ipilimumab. The duration of patient participation may be more than 3 years. If enrolled in treatment, the exact length of time will depend on the patients response to treatment.

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

Translating an Evidence-based Urban Asthma Program for Rural Adolescents: Testing Its Effectiveness & Cost-effectiveness and Understanding Implementation Factors Save

Date Added
August 1st, 2017
PRO Number
Pro00069047
Researcher
Phillippe Cunningham
Keywords
Adolescents, Asthma, Education
Summary

Asthma has high morbidity and mortality among adolescents and among youth from rural communities, both of whom are seldom included in asthma intervention research. This study will test the effectiveness and cost-effectiveness of high school-based intervention delivered by Community Health Workers (CHWs) to rural adolescents with uncontrolled asthma, and will examine factors associated with delivery of the intervention.

Institution
MUSC
Recruitment Contact
Phillippe Cunningham
843-876-1800
cunninpb@musc.edu

A multicenter, multinational, randomized, double-blind, pharmacokinetic and pharmacodynamic (PK/PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Save

Date Added
July 25th, 2017
PRO Number
Pro00067181
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for pediatric patients that have been diagnosed with cancer and are receiving chemotherapy. The investigational drugs in this study are netupitant and palonosetron. The purpose of this study is to learn more about how well the combination of oral netupitant and oral palonosetron works in preventing nausea and vomiting associated with chemotherapy in children. Participation in the study will last for a maximum of 31 days, which includes a screening period up to 14 days before randomization (up to 7 days for patients aged less than 2 years), the day of enrollment/randomization, administration of study drugs and chemotherapy (Study Day 1), and the control visits (Study Days 2 to 5).

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

Change_preferences

-- OR --

Create_login