A Phase III Trial of Post-Surgical Stereotactic Radiosurgery (SRS) Compared with Whole Brain Radiotherapy (WBRT) for Resected Metastatic Brain Disease. + save

Date Added
October 17th, 2014
PRO Number
Pro00020277
Researcher
Pierre Giglio
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this research study is to compare overall survival and to compare the effects (good and bad) of stereotactic radiosurgery (SRS) to whole brain radiation therapy (WBRT) on the subject and their brain metastases.
To be eligible, the results of the MRI must show that the subject have at least one but no more than four brain metastases with one of the brain metastases resected. The study doctor must also verify that the subject meets other study requirements, such as not being pregnant. If the subjects are eligible and agree to participate, they will be randomized into one of the two treatment groups. The two treatment groups are: (Group A) whole brain radiation therapy (WBRT) and (Group B) stereotactic radiosurgery (SRS)
The study team would like to keep track of the subjects medical condition as long as the subject is alive or for a maximum of five years after the subject begins this study to look for any long-term effects of the treatment in this study.

Institution
MUSC
Recruitment Contact
John Keller
843-792-1286
kellej@musc.edu

Effect of left lateral position and Valsalva maneuver on uterine artery Pulsatility and Resistance indices in first and second trimester of pregnancy. + save

Date Added
April 14th, 2014
PRO Number
Pro00033466
Researcher
Sanjay Patwardhan
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This study will look at abnormal blood circulation changes especially in the arteries supplying blood to the uterus (where the baby develops) using Doppler ultrasound. The research team will perform Doppler ultrasound scans at an early pregnancy scan and during the fetal anatomy scan to understand blood flow changes when subjects are lying on their back versus when they are tilted to their left and also when they bear down for 10 seconds.

Institution
MUSC
Recruitment Contact
Tamara Pfeffer
843.792.0316
pfeffer@musc.edu

Clinical Evaluation of the AmniSure ROM Test + save

Date Added
April 8th, 2014
PRO Number
Pro00025491
Researcher
Scott Sullivan
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to evaluate whether the AmniSure ROM (Rupture of [fetal] Membrane) test read by personnel in the subject’s room gives the same result as the AmniSure ROM test read in a laboratory. Researchers will then look to see how both results compare to the results of three standard test methods to detect ruptured (broken) fetal membranes (rupture of the sac where the fetus develops). These standard tests are called nitrazine, ferning, and pooling.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
saundert@musc.edu

The effects of in utero exposure of antiretroviral therapy on neonate body fat distribution. + save

Date Added
April 4th, 2014
PRO Number
Pro00024418
Researcher
Gweneth Lazenby
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to compare body fat distribution in neonates exposed to antiretroviral (ARV) therapy for the prevention of maternal to child transmission (MTCT) of HIV versus ARV naive neonates born at a similar gestational age to HIV-negative women. As a secondary analysis, we will examine the differences in body fat distribution among ARV-exposed neonates comparing PI-exposed versus non-PI exposed.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843-792-6323
yeadon@musc.edu

Provocative stress testing: comparing the standing versus supine method + save

Date Added
April 2nd, 2014
PRO Number
Pro00032857
Researcher
Radhika Patnam
Keywords
Obstetrics and Gynecology, Women's Health
Summary

The purpose of this study is to see if the common way to diagnose stress urinary incontinence (when sneezing, coughing or laughing causes accidental leaks) in women is more effective when the patient is standing versus lying down.

Institution
MUSC
Recruitment Contact
JacKetta Cobbs
843.792.3330
cobbsj@musc.edu

A Multi-Center, Open-Label, First-in-Human, Phase I Dose-Escalation Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6839921, An MDM2 Antagonist, Following Intravenous Administration in Patients with Advanced Malignancies, including Acute Myeloid Leukemia (AML) + save

Date Added
March 25th, 2014
PRO Number
Pro00033053
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

This study involves the use of RO6839921, a new investigational drug, which means that it has not been approved by the Food and Drug Administration (FDA). This is the first study using RO6839921 in humans. However in animal studies, RO6939921 has demonstrated the ability to kill cancer cells.
At least 3 patients will participate in the initial phase of this study and will be referred to as “Cohort 0”. The patients in Cohort 0 will be given RO6839921 for one cycle of 28 days. After these patients have completed one cycle, the study will be stopped and all of the data from these patients will be reviewed very carefully with the FDA. Once the FDA says it is OK with the results following the treatment of patients in Cohort 0, more patients will be able to join the study. This study will look for the highest safe dose of RO6839921 that can be given to patients with solid tumor cancer (Arm A) or acute myelogenous leukemia (AML) (Arm B). Any side effects associated with the use of RO6839921 will be carefully monitored by your study doctor.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@musc.edu

A Phase III Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™ + save

Date Added
March 25th, 2014
PRO Number
Pro00032940
Researcher
David Soper
Keywords
Obstetrics and Gynecology, Women's Health
Summary

This study is an extension study designed to learn more about an HPV vaccine. This study will focus on women who participated in the first study but were assigned to the group that did not receive any of the study drug (vaccine). This study will offer the women the choice to receive 3 shots of the HPV vaccine.

Institution
MUSC
Recruitment Contact
Betty Oswald
843-792-0347
oswaldbw@musc.edu

Mobile Patient-Centered Preterm Birth Prevention Surveillance Program- UAM Validation + save

Date Added
March 7th, 2014
PRO Number
Pro00032491
Researcher
Roger Newman
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this project is to test the accuracy, acceptability and overall performance of a smart phone surveillance application (app) that is being developed to help prevent preterm birth. The smart phone app will measure contractions of pregnant women who are in labor. The results of the smart phone app will be compared with the results that are taken by the traditional machine that is used to measure contractions for women who are in labor.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843.792.6992
saundert@musc.edu

Utilizing Text Messaging to Encourage Women with Fibromyalgia to Engage in Physical Activity: A Feasibility Study + save

Date Added
March 6th, 2014
PRO Number
Pro00031705
Researcher
Kathryn Vanravenstein
Keywords
Exercise, Fibromyalgia, Pain, Women's Health
Summary

To encourage women with Fibromyalgia to engage in physical activity using text messaging as means of encouragement. This is a 12 week study the will utilize various stretching exercises along with a pedometer to increase daily physical activity. Subjects will keep a daily diary of there activity, pain, and sleep and complete on-line questionnaires at the beginning and end of the study.

Institution
MUSC
Recruitment Contact
Kathryn VanRavenstein
920-659-3334
kav6@musc.edu

Specimen Collection from Pregnant Women at Increased Risk for Fetal Chromosomal Aneuploidy for use in Development of a Noninvasive Fetal Aneuploidy Test + save

Date Added
February 25th, 2014
PRO Number
Pro00010416
Researcher
Charles Rittenberg
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This is a multicenter, observational study.
This research study will test whether the methods being developed for the detection of fetal aneuploidy from samples of maternal blood can be used in the laboratory and employed in clinical practice

Institution
MUSC
Recruitment Contact
Betty Oswald
843 792 0347
oswaldbw@musc.edu