A Multi-Center, Double-Blind, Placebo-Controlled, Dose-Titration Study Evaluating the Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of Oxybutynin Chloride Topical Gel for the Treatment of Detrusor Overactivity Associated with a Neurological Condition in Pediatric subjects + save

Date Added
June 23rd, 2011
IRB Number
20700
Researcher
J. Purves
Keywords
Adolescents, Bladder, Children's Health, Drug Studies, Pediatrics, Urinary
Summary

This is a pediatric study for treatment of Overactive bladder in patients that have a neurological condition that causes the overactivity of the bladder.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

PBMTC ONC-032: High dose temozolomide, thiotepa and carboplatin with autologous stem cell rescue (ASCR) followed by continuation therapy with 13-cis-retinoic acid in patients with recurrent/refractory malignant brain tumors + save

Date Added
March 12th, 2011
IRB Number
17369
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Blood Disorders, Brain, Brain Tumor, Cancer/Brain, Children's Health, Drug Studies, Pediatrics, Transplant
Summary

This study is for patients 21 years and younger with a brain tumor that has not responded to treatment or has come back after treatment. The purpose of this study is to find out how safe and effective treatment with high dose temozolomide, thiotepa and carboplatin with stem cell rescue followed by 13-cisretinoic acid has on children and adolescents with recurrent/refractory brain tumors. Before study treatment, patients will receive chemotherapy to decrease the size of the tumor. During this chemotherapy, patients will have their stem cells collected. After collection, the stem cells are frozen and stored until they are needed after the high dose chemotherapy (temozolmide, thiotepa and carboplatin). Patients will receive the 13-cis-retinoic acid 6 to 10 weeks after stem cell rescue. It is given for 14 days followed by a 14 day rest period. This cycle is given 6 times for a total of 6 months of treatment. Patients will be treated on this study for about 7 to 8 months.

Institution
MUSC
Recruitment Contact
Karen Rogers
843-792-8856
rogersk@musc.edu

Melody Transcatheter Pulmonary Valve (Melody TPV) and Ensemble Transcather Valve Delivery System (HDE) + save

Date Added
August 9th, 2010
IRB Number
20355
Researcher
George Baker
Keywords
ADD/ADHD, Cardiovascular, Children's Health, Heart, Infant, Pediatrics, Surgery, Throat
Summary

For pediatric cardiac patients - a Humanitarian Device Exemption Study (HDE)

Institution
MUSC
Recruitment Contact
Patricia Infinger
843-792-7857
infingep@musc.edu

Pediatric Metabolic Syndrome Study + save

Date Added
October 5th, 2009
IRB Number
19375
Researcher
Melissa Henshaw
Keywords
Adolescents, Children's Health, Nutrition, Obesity, Pediatrics
Summary

Comprehensive assessments of obese 4 to 21 year olds at no charge to participants; compensation is available.

Our research study permits obese children and adolescents to get free state-of-the-art evaluations through our Clinical and Translational Research Center. Nutrition assessments, fasting labs, body composition scans, and cardiac echos will be provided to participants at no charge.

Institution
MUSC
Recruitment Contact
Janet Carter, RD
843-792-4717
catjan@musc.edu

The NICHD Fetal growth Study (NFGS) + save

Date Added
October 5th, 2009
IRB Number
18966
Researcher
Roger Newman
Keywords
Children's Health, Infant, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Normal growth of your baby during pregnancy is very important for the long term health of your child. Currently there are no reliable tests that allow us to accurately measure fetal growth, or to determine the normalcy of that growth.

The purpose of this study is to better understand how normal babies grow and develop inside the womb during an uncomplicated pregnancy.

Developing a normal standard will help us better identify growth abnormalities. We will also try to identify causes of growth abnormalities among normal women.

If you decide to be in the study you and your baby may not directly benefit from participation. However if you participate and a serious pregnancy problem is detected during a study exam you will be referred for follow-up care. Because this study is looking at improving our knowledge of normal fetal growth, your participation can potentially help many mothers and their babies in the future.

If you have not yet had an ultrasound done during this pregnancy, one will be preformed, to confirm your gestational age.

Provide the study staff with information about any medical problems you may have, your past pregnancies and social history.

You will receive a total of 6 ultrasound examinations during your pregnancy. During these exams we will perform specific 2-D and 3-D measurements of your baby. At each study visit, we will collect information on any medical problems you may have had.

At each visit we will take body measurements on you such as your weight, height, arm, leg and waist measurements.

At four of the study visits, a small amount of blood will be drawn from you; usually at the time of other scheduled blood work.
Some patients will be asked additional questions about their nutritional intake.

Information will be obtained from your delivery records and the baby's hospital birth records after delivery.

After you delivery, we will obtain more body measurements on both you and your baby.

Some patients may be asked to donate their placentas as well as a small amount of blood from the umbilical cord.

Institution
MUSC
Recruitment Contact
Carolyn Williams
843-792-0349
willacg@musc.edu

"Closure of Atrial Septal Defects with the AMPLATZER Septal Occluder Post Market Study (ASD PMS II)" + save

Date Added
October 5th, 2009
IRB Number
18165
Researcher
George Baker
Keywords
Cardiovascular, Children's Health, Heart, Infant
Summary

Open only to children and adults with atrial septal defect (ASD).
The purpose of this study is to gather more information about how effective the AMPLATZER® ASD Occluder is at closing the hole in your heart, collecting information about the safety of the device, as well as obtaining long-term survival data on patients who receive this device.

The AMPLATZER® Septal Occluder is approved by the FDA to close atrial septal defects. Neither the device nor any of the procedures or tests used in this study is considered experimental.

The AMPLATZER® Septal Occluder is a self-expandable, double disc device made from a nickel-titanium (nitinol) wire mesh. The two discs are linked together by a short connecting waist. The discs and waist have polyester fabric sewn into them. The polyester fabric is the same kind that is used by surgeons to close other heart defects.

Institution
MUSC
Recruitment Contact
Patricia Infinger
843-792-7857
infingep@musc.edu

Closure of Muscular Ventricular Septal Defects with the Amplatzer Muscular VSD Occluder Post Approval Study + save

Date Added
October 5th, 2009
IRB Number
17870
Researcher
Varsha Bandisode
Keywords
Cardiovascular, Children's Health, Heart, Pediatrics
Summary

This study is for people that have a ventricular septal defect (VSD) which is an opening between the right and left lower chambers of your heart. This opening may allow blood from the left heart chamber to cross the VSD, into the right side of the heart. As part of this research study, an implant called the AMPLATZER Muscular VSD Occluder is implanted into the body to close the hole in your heart. The AMPLATZER Muscular VSD Occluder device is an approved device. The device, procedure and tests in this study are not considered experimental.

Institution
MUSC
Recruitment Contact
Tricia Infinger
843-792-7857
infingep@musc.edu

Establishing the Vitamin D Requirements during Lactation + save

Date Added
October 5th, 2009
IRB Number
16536
Researcher
Carol Wagner
Keywords
Children's Health, Exercise, Metabolism, Nutrition, Pediatrics, Vitamin D, Women's Health
Summary

Women within the first month postpartum are eligible to enroll in this vitamin D supplementation study if they are either exclusively breastfeeding or exclusively formula-feeding. Each mother and her infant are followed for six months. Mothers are randomized to one of two groups: to receive 400 or 6400 IU vitamin D/day for six months. Infants receive vitamin D drops containing either 400 or 0 IU/day depending on their mother's group. Blood, urine and milk (if breastfeeding) are obtained from mother at each visit. Blood is obtained from infant at visits 1, 4 and 7. Both mother and infant have a bone scan to determine the health of their bones.

Institution
MUSC
Recruitment Contact
Judy Shary
843-530-5872
sharyj@musc.edu

Systemic Lupus Erythematosus in Gullah Health (SLEIGH) + save

Date Added
October 5th, 2009
IRB Number
10852
Researcher
Diane Kamen
Keywords
Autoimmune disease, Children's Health, Environmental Factors, Ethnicity and Disease, Healthy Volunteer Studies, Immune System, Joint, Kidney, Lupus, Minorities, Non-interventional, Vitamin D, Women's Health
Summary

The Systemic Lupus Erythematosus (SLE) in Gullah Health, or SLEIGH, study is an observational study enrolling African Americans from the Sea Island communities of South Carolina and Georgia. We are enrolling patients, family members of patients, and unrelated community members. SLE is a potentially severe disease that can affect the entire body. SLE is more common in African Americans than Caucasians. The main purpose of this study is to find genes that, along with factors from the environment, result in the development of SLE. Volunteers in SLEIGH will be asked to answer questions about their health and have blood and urine collected for tests. After the first visit there may be one additional visit 2 or more years later. This is not a drug study.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-8997
slans@musc.edu