A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies Save

Date Added
April 26th, 2016
PRO Number
Pro00034909
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

AZD5363 is a new anti-cancer treatment being developed by AstraZeneca that has not yet been approved for use. This study is part of a research project for collecting information about the safety and effectiveness of this treatment for the first time. The main purpose of the study is to establish a safe dose of the drug by gathering information on how well it is tolerated, any potential side effects it may cause and collecting data about how your cancer responds to the drug. The study will also measure the levels of AZD5363 in the blood and the action of AZD5363 in the body over a period of time. It will also indicate whether the drug has an effect on the type of cancer that the subjects have.

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

PH IRB #2012-061; Pro00017643: Lung Cancer Surgery: Decisions Against Life Saving Care ? The Intervention. Save

Date Added
April 20th, 2016
PRO Number
Pro00017643
Researcher
Rohan Arya
Keywords
Cancer, Cancer/Lung, Ethnicity and Disease, Men's Health, Minorities, Pulmonary, Stage I, Stage II, Surgery, Women's Health
Summary

Lung cancer is the leading cause of cancer death with a higher mortality rate among African Americans. For patients that have stage I or II non-small cell cancer, surgery is the only curative treatment. In a previous study we conducted, we found that African Americans were less likely to have surgery than other groups. The purpose of this study is to find out what patients understand about their medical condition, what can be done to get the very best lung cancer surgery treatment, and how we can close the treatment gap.

Institution
Palmetto
Recruitment Contact
Alisha Henderson
803-799-5022
alisha.henderson@uscmed.sc.edu

Personalized Biobehavioral Weight Loss Intervention for African American (AA) Women Save

Date Added
April 19th, 2016
PRO Number
Pro00017235
Researcher
Gayenell Magwood
Keywords
Disease Prevention, Genetics, Minorities, Obesity, Weight Control, Women's Health
Summary

This study will use focus groups, individual interviews and secondary data analysis to gather information to gain better understanding of best source, format and preference for a weight loss intervention and receiving health information that integrate genetics, socio-environmental, and behavioral factors into a promising multi-level community based intervention for obesity and obesity promoting behaviors in African American (AA) women.

Institution
MUSC
Recruitment Contact
Gayenell Magwood
843-792-1418
magwoodg@musc.edu

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Assess the Efficacy and Safety of Farletuzumab (MORAb-003) in Combination with Carboplatin plus Paclitaxel or Carboplatin plus Pegylated Liposomal Doxorubicin (PLD) in Subjects with Low CA125 Platinum-Sensitive Ovarian Cancer Save

Date Added
April 12th, 2016
PRO Number
Pro00043131
Researcher
Whitney Graybill
Keywords
Cancer, Cancer/Gynecological, Drug Studies, Women's Health
Summary

This study is for patients that have been diagnosed with platinum-sensitive ovarian cancer.The investigational drug in this study is Farletuzumab. The main purpose of this study is to find out if carboplatin plus paclitaxel or carboplatin plus Pegylated Liposomal Doxorubicin (PLD), chemotherapies (anticancer drugs) that are used to treat ovarian cancer, work better alone or when given with an farletuzumab.
The estimated total duration of this study will be approximately 46 months (1 month screening, 15 months treatment, and 30 months follow-up). The actual total duration will vary depending on subject response to drug and disease progression

Institution
MUSC
Recruitment Contact
Vistea Crawford
843-792-6429
crawforv@musc.edu

Assessing the Potential of a Home-Based Prenatal Care Model by Comparing Patient to Provider Measurements Save

Date Added
April 6th, 2016
PRO Number
Pro00030991
Researcher
Krista Wagoner
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to compare routine prenatal measurements taken by patients to the same measurements that are taken by the provider.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-1413
paynej@musc.edu

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients Save

Date Added
April 5th, 2016
PRO Number
Pro00017387
Researcher
Jennifer Jaroscak
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

This study if for patients that have a blood disease and it's been determined that the best option for treating that blood disease is a cord blood transplant. Cord blood (CB) is blood that is taken from the umbilical cord and placenta of healthy newborn babies after childbirth. The cord blood collected from a newborn baby is called a cord blood unit. The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. These are considered ?investigational? products. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-2708
simonsjl@musc.edu

A211102, Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology after 12 months Metformin (1, 1-Dimethylbiguanide Hydrochloride) Chemoprevention versus Placebo Control in Premenopausal Women Save

Date Added
March 29th, 2016
PRO Number
Pro00043305
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Breast, Women's Health
Summary

This study is for females, ages 25-55, who have tested positive for atypia (early cell changes that are thought to be a marker of breast cancer risk) in the breast, and are considered high risk for the development of breast cancer in the future.

The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (marker of breast cancer risk) in women at increased risk for breast cancer. This study will test for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study sponsor would like to compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. In this study, patients will get either metformin or a placebo (an inactive product) for the first twelve months. After the first twelve months, women who received placebo during the first twelve months can choose to receive metformin for the second year.

Note: The standard drug used for the ?breast cancer prevention? is tamoxifen. If you are eligible to take tamoxifen, you must be offered tamoxifen prevention as part of your clinical care and you must have refused tamoxifen treatment to be on this study. Metformin and tamoxifen are not similar and function differently. This study is not investigating the use of tamoxifen.

While on this research study patients will have the Random Periareolar Fine Needle Aspiration (RPFNA) of their breasts to test for atypia (marker of breast cancer risk), before the study starts, and also at 12 and 24 months (24 month optional for placebo-only group for patients who remain on placebo arm and will not receive metformin) after the study starts. If the pathologist does not identify atypia in the samples you will not be able to participate. You will also provide blood during this study to determine if changes in your blood are related to changes in your breasts. You will need to provide a little less than 4 tablespoons of blood for this research study.

Study participation will last for 48 months (2 years).

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

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

Date Added
March 23rd, 2016
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
843-792-6323
yeadon@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
March 23rd, 2016
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

A single-blind, multi-centre, randomised, controlled, non-inferiority, clinical study to assess the safety and performance of the Neurotech Vital Compact device compared to the itouch Sure Pelvic Floor Exerciser for the treatment of stress urinary incontinence in female patients Save

Date Added
March 22nd, 2016
PRO Number
Pro00043185
Researcher
Steven Swift
Keywords
Bladder, Obstetrics and Gynecology, Urinary, Women's Health
Summary

The purpose of this study is to test the safety and performance of an experimental device that is intended to strengthen the pelvic floor muscles of women who have stress urinary incontinence. To do so, this study will compare the results of the two devices and see if there are any differences in the treatment of stress urinary incontinence if the electrical stimulation is delivered through electrodes placed on the outside of the body (Neurotech Vital Compact device) or electrical stimulation delivered through an internal vaginal probe (the itouch Sure Pelvic Floor Exerciser). Qualified patients who choose to volunteer in the study will be asked to participate in 5 study-related visits and will be involved in the study for 6 months. Study subjects will spend a total of 127 hours actively participating in study activities throughout a 14-week period. The total amount of time they will be involved in the study will be 6 months. Study subjects will be asked to perform some of the study activities independently at their home.

Institution
MUSC
Recruitment Contact
Betty Oswald
843.792.0347
oswaldbw@musc.edu

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