Cognitive Impairment and Obstructive Sleep Apnea Syndrome in Post-Menopausal Women Save

Date Added
June 16th, 2015
PRO Number
Pro00025410
Researcher
Chitra Lal
Keywords
Memory Loss, Sleep Disorders, Women's Health
Summary

Early postmenopausal women are vulnerable to memory loss and other cognitive deficits. Obstructive Sleep Apnea Syndrome (OSAS) has been associated with memory loss and cognitive decline. OSAS is also more common after menopause. This study seeks to define the prevalence of these cognitive deficits in postmenopausal women with OSAS as compared to postmenopausal women who don't have OSAS with the use of screening questionnaires. We are seeking postmenopausal women, between 45-60 years of age, within 5 years of natural menopause. Interested participants may also qualify for a brain imaging study to perform visual tasks in the MRI scanner.

A survey is required to initiate your interest. The 15 minute survey can be completed by going to this link:

https://redcap.musc.edu/surveys/?s=usDfDc

Institution
MUSC
Recruitment Contact
Chitra Lal
843-792-7776
lalch@musc.edu

Cervical pessary to prevent preterm birth in singleton pregnancies with a sonographically measured short cervix: an open-label randomized controlled trial Save

Date Added
June 16th, 2015
PRO Number
Pro00044532
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to determine if a pessary, a silicone device placed within the vagina to support the cervix, could be a good way to help pregnant women who are at risk for preterm delivery. The pessary that is used in this study, called the Arabin pessary, has not been approved by the United States Food and Drug Administration (FDA) for the prevention of preterm delivery. It is an investigational device, which means it is still being studied to find out whether or not it is safe and effective in patients with a short cervix who are at risk for preterm delivery.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843.792.6323
yeadon@musc.edu

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications Save

Date Added
June 16th, 2015
PRO Number
Pro00011805
Researcher
Robert Stuart
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
•Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
•Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

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

Phase II Trial of Everolimus or Everolimus Plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma Save

Date Added
June 9th, 2015
PRO Number
Pro00019706
Researcher
Harry Drabkin
Keywords
Cancer, Men's Health, Women's Health
Summary

This is a study for subjects with transitional cell carcinoma. Transitional cell carcinoma (TCC) is a type of cancer that is usually from the bladder, but can also be from organs associated with the bladder, such as the ureters (tubes connecting the bladder with the kidneys). This research study is evaluating a drug called Everolimus, also known as RAD001, which will be used either alone or with another drug called Paclitaxel as a possible treatment for TCC. Patients with this type of cancer routinely receive Cisplatin-based cancer treatment. However, the study doctor may think that this routine Cisplatin-based cancer treatment will not be good for the patient due to the disease or health condition. After discussing with the study doctor, the patient has the option of participating in this study to receive either Everolimus alone (cohort1) or Everolimus in combination with Paclitaxel (cohort2).
If the patient chooses to take part in cohort 1 of this study, the patient will take Everolimus 10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis. The patient will be provided with an adequate supply of Everolimus for self-administration at home.
If the patient chooses to take part in cohort 2 of this study, the patient will receive Everolimus 10 mg daily orally, as described above, along with Paclitaxel 80mg/m2 given intravenously (in your veins), over one hour on days 1,8 and 15 of a 28-day cycle
The study team would like to keep track of the patient's medical condition for the rest of their life. The study team would like to do this by calling the patient on the telephone once every few months (every 3 months for 2 years from registration for protocol therapy, every 6 months for years 3 - 5 and annually thereafter) to see how the patient is doing. Keeping in touch with the patient and checking the condition helps the study team look at the long-term effects of the research study.

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

A Phase 1B Open-Label Three-Arm Multi-Center Study to Assess the Safety and Tolerability of PF-05212384 (PI3K/mTOR Inhibitor) in Combination with Other Anti-Tumor Agents Save

Date Added
June 9th, 2015
PRO Number
Pro00027912
Researcher
Carolyn Britten
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is enrolling male and female patients with a diagnosis of advanced solid tumor. The purpose of this research study is to learn about the effects of and to find the best dose of the study drug, PF 05212384, when given in combination with other drugs. This study will determine the highest dose of PF-05212384 that can be tolerated when given in combination with other drugs; this PF-05212384 dose is called the maximum tolerated dose or MTD. Enrolled patients can expect to be in this study for about 6 months. They will need to visit the research site at least 12 times during the study. Patients may stay in the study until the disease gets worse or they decide to stop participating.

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
May 18th, 2015
PRO Number
Pro00017643
Researcher
Maria del mar Cirino-marcano
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

A Randomized Phase 2 Study Comparing Docetaxel Alone to Docetaxel in Comination with OGX-427 in Patients with Relapsed or Refractory Metastatic Urothelial Carcinoma after Receiving Platinum-containing Regimen Save

Date Added
May 12th, 2015
PRO Number
Pro00026419
Researcher
Harry Drabkin
Keywords
Cancer, Cancer/Genitourinary, Men's Health, Women's Health
Summary

This study is for subjects who have inoperable (surgical treatment is not an option) or metastatic (has spread to other parts of the body) urothelial carcinoma (includes cancer of the bladder, urethra, ureter or renal pelvis) and who are not responding to platinum-based chemotherapy (such as carboplatin or cisplatin).
This study will evaluate whether treatment with OGX-427 in combination with docetaxel can prolong survival time compared to treatment with docetaxel alone in patients with urothelial carcinoma (UC) who are no longer responding to treatment with a platinum-based chemotherapy regimen. Docetaxel (also known as Taxotere®) is commercially available and is approved by the Food and Drug Administration (FDA) in the United States for the treatment of breast, stomach, lung, prostate and head and neck cancers. OGX-427 is a new drug that is experimental (not approved by the FDA).
The use of docetaxel in combination with the experimental drug OGX 427 in this study is investigational. “Investigational” means that the combination of drugs is being studied. It also means that the FDA (the U.S. Food and Drug Administration) has not yet approved this combination of drugs.
Subjects in Group A will receive 9 days of loading doses, 10 cycles of combined treatment at 3 weeks per cycle, and maintenance treatment with OGX-427 only until the disease progresses or they experience unacceptable side effects.
Subjects in Group B will receive 10 cycles of docetaxel alone at 3 weeks per cycle, for a total of about 30 weeks. Everyone who completes study treatment with no evidence of disease progression will be followed every 6 weeks until disease progression. Everyone will be followed every 3 months after disease progression for survival.

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

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
May 12th, 2015
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

A pilot study evaluating vitamin D deficiency and risk of aggressive uterine cancer in African American as compared to White women Save

Date Added
May 7th, 2015
PRO Number
Pro00030938
Researcher
Whitney Graybill
Keywords
Cancer/Gynecological, Women's Health
Summary

The purpose of this study is to evaluate vitamin D levels in African American and White women who present with a new diagnosis of uterine cancer.

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

An Open-Label Phase I Dose-Escalation Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Maximum Tolerated Dose Of BAY 1143572 Given In A Once-Daily Or An Intermittent Dosing Schedule In Subjects With Advanced Malignancies Save

Date Added
April 28th, 2015
PRO Number
Pro00043216
Researcher
Carolyn Britten
Keywords
Cancer, Cancer/Breast, Men's Health, Stomach, Women's Health
Summary

This research study examines the investigational study drug, BAY 1143572 because it is believed the drug may have an effect on the growth of cancer. This study is enrolling people who have been diagnosed with diffuse large B-cell lymphoma (DLBCL), gastric (stomach) cancer or triple negative breast cancer.
The purpose of the study is to evaluate the safety, tolerability and maximum tolerated dose of BAY 1143572. This study is considered research because the study drug BAY 1143572 is investigational (experimental) and has not been approved by the U.S. Food and Drug Administration (FDA) for sale yet. this drug has not been tested in humans. The amount of time participants can expect to be in this study depends on well he or she responds to the treatment.

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

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