A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate with Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects with Overactive Bladder Save

Date Added
April 28th, 2015
PRO Number
Pro00034068
Researcher
Steven Swift
Keywords
Obstetrics and Gynecology, Women's Health
Summary

The purpose of this study is to examine how well tolerated and how effective two medicines given together (solifenacin succinate and mirabegron) are in the treatment of your bladder problems over a 54-week period. Both these medications have already been shown to be effective in treating OAB if given separately.

Institution
MUSC
Recruitment Contact
Betty Oswald
843.792.0347
oswaldbw@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
April 21st, 2015
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

NRG-CC002: PRE-OPERATIVE ASSESSMENT AND POST-OPERATIVE OUTCOMES OF ELDERLY WOMEN WITH GYNECOLOGIC CANCERS Save

Date Added
April 21st, 2015
PRO Number
Pro00043352
Researcher
Jeffrey Elder
Keywords
Aging, Cancer, Cancer/Gynecological, Geriatrics, Surgery, Women's Health
Summary

Participants in this study fall in an older age group and are suspected to have ovarian, fallopian tube, peritoneal or uterine cancer. The usual approach to advanced stage ovarian, fallopian tube, peritoneal or uterine cancer is surgery to remove the cancer and chemotherapy. The surgery could be first in treatment followed by chemotherapy or chemotherapy could be given first to shrink the cancer, possibly followed by surgery and then more chemotherapy. It is sometimes difficult to assess whether a person aged 70 years or older is a good surgical candidate. This study is evaluating a geriatric assessment tool (a questionnaire and some blood work) which would help physicians identify older patients who would do well with surgery. Whether or not patients participate in this study, they will receive treatment and surgery as recommended by thier physician.

Participants will receive the geriatric assessment questionnaire when they are seen by their doctor for consideration of surgery or shortly thereafter. If participants undergo surgery before or after chemotherapy they will be followed for six weeks after surgery to see if they have any complications and what they are. If participants do not have surgery, they will have completed the study once they complete the geriatric assessment questionnaire.

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

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

Date Added
April 15th, 2015
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 Phase Ib Open Label Study of the Safety and Tolerability of ME-344 Given in Combination with Topotecan (Hycamtin®) in Patients with Solid Tumors MEI Pharma ME-344-002 Save

Date Added
April 14th, 2015
PRO Number
Pro00033758
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

This study is being done to determine how subjects with small cell lung cancer, ovarian cancer and cervical cancer respond to doses of an investigational drug, ME 344 in combination with topotecan, and to determine the dose of ME-344 that can be given in combination with topotecan. "Investigational" means that ME-344 has not been approved by the United States Food and Drug Administration (FDA) for use outside of research studies. Topotecan has been approved by the FDA for treatment of small cell lung cancer, ovarian cancer, and cervical cancer. There are two parts to this study.
In Part 1, the study drug will be tested at a certain dose in combination with topotecan in 12 subjects. If no bad side effects happen, the next group of subjects will receive that dose in the study. However, if side effects are seen that are not considered tolerable, then the next group of 12 subjects will receive a lower dose of the study drug.
In Part 2, 40 subjects will receive the dose of the study drug that was determined to work best in Part 1 in combination with topotecan.
Not all subjects will stay in the study for the same amount of time. Study drug will be given in “cycles” of approximately 28 days each. The number of cycles you receive will depend on how well you tolerate the study drug, and your overall condition.

Institution
MUSC
Recruitment Contact
James Brisendine
843-792-9007
brisend@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
April 14th, 2015
PRO Number
Pro00043185
Researcher
Steven Swift
Keywords
Obstetrics and Gynecology, 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

A Phase II Randomized, Double-Blind Study of Dalantercept plus Axitinib Compared to Placebo plus Axitinib in Patients with Advanced Renal Cell Carcinoma Save

Date Added
April 14th, 2015
PRO Number
Pro00033034
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

This study is for individuals with renal cell carcinoma (RCC). The purpose of this study is:

•To find out whether the study treatment can stop your RCC from growing, or prevent it from growing as fast as it would without dalantercept.
•To evaluate the safety of the study treatment in subjects with RCC.
•To find out if the study treatment has an effect on biomarkers (molecules that indicate how well you respond to study treatment) in your blood and/or tissue.

Participants will receive a dose of dalantercept or placebo (a substance with inactive drug that looks the same as dalantercept) plus axitinib. It is expected that a participant will be on this study for a variation of time (total duration will vary per subject).

Institution
MUSC
Recruitment Contact
Seth Price
843-792-1918
pricesr@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 7th, 2015
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

Pro00039400: The impact of percutaneous minitracheostomy on patients with spontaneous intracerebral hemorrhage and acute respiratory insufficiency: a pilot study Save

Date Added
April 6th, 2015
PRO Number
Pro00039400
Researcher
William Owens
Keywords
Hypertension/ High Blood Pressure, Men's Health, Nervous System, Stroke, Women's Health
Summary

Patients with spontaneous non-traumatic intracerebral bleeding and acute respiratory insufficiency will be considered for a minitracheostomy to help facilitate suctioning and airway clearance. Selected patients will be adults who are intubated for at least 24 hours, who are not candidates for surgical evacuation of the hematoma, and who are considered to be higher risk for extubation failure based on depressed mental status and airway secretions. After obtaining informed consent for the procedure, a spontaneous breathing trial will be performed to make sure that the patient is capable of breathing without the assistance of the mechanical ventilator. A small, 1 cm incision will be made over the cricothyroid membrane using standard aseptic precautions and local anesthesia. The endotracheal tube will be withdrawn, and the minitracheostomy catheter will be passed through the incision into the airway. The minitracheostomy catheter will remain in place until the patient's attending physician feels that it is no longer needed for airway clearance.

Institution
Palmetto
Recruitment Contact
Mia Kiefer
803-799-5022
mia.kiefer@uscmed.sc.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 1st, 2015
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

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