Anthropometric findings as predictors for gestational diabetes and pre-eclampsia. Save

Date Added
January 21st, 2015
PRO Number
Pro00038288
Researcher
Yeonjung Park
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This study will be looking to determine if specific clinical signs found in pregnant women (skin tags and darkended areas of skin) may be associated with a greater risk of a pregnant woman developing gestational diabetes and preeclampsia.

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

Structural Artery Defects at the Utero-placental Unit in Preeclampsia Save

Date Added
January 20th, 2015
PRO Number
Pro00040396
Researcher
Julio Mateus nino
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to learn more about blood vessel defects in the placental bed and in the placenta of women who have pregnancies that are complicated by preeclampsia.

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

A Multicenter Phase 1/2b Study of the Bruton’s Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination with Carfilzomib (Kyprolis™) in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma Save

Date Added
January 13th, 2015
PRO Number
Pro00031755
Researcher
Saurabh Chhabra
Keywords
Cancer, Men's Health, Women's Health
Summary

This study if for patients that have been diagnosed with muliple myeloma. Pharmacyclics, Inc. (the Sponsor) is studying an investigational new drug called ibrutinib. Ibrutinib is a type of drug called a “kinase inhibitor”. “Kinases” are proteins inside cells that help cells live and grow. The specific kinase inhibited or “blocked” by ibrutinib is believed to help blood cancer cells live and grow. By inhibiting the activity of this specific kinase, it is possible that the ibrutinib may kill the cancer cells or stop them from growing.

The study has two parts:
• Phase 1 tests different doses of ibrutinib and carfilzomib together to study what dose to use in Phase 2b
• Phase 2b will study the effects of the treatment. All subjects will receive carfilzomib, only half of the subjects will receive ibrutinib, to test if there is a benefit to adding ibrutinib to carfilzomib treatment
Participation in this study will last approximately two years. This will include coming to the study center for treatment and follow-up after the study treatment ends.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

A Phase Ib/II Multi-Center, Open Label, Dose Escalation Study of WNT974, LGX818 and Cetuximab in Patients with BRAFV600-Mutant KRAS wild-type Metastatic Colorectal Cancer Harboring Wnt Pathway Mutations Save

Date Added
January 13th, 2015
PRO Number
Pro00040875
Researcher
Carolyn Britten
Keywords
Cancer, Men's Health, Women's Health
Summary

The purpose of this study is to assess the safety and anti-tumor activity of the triple combination of investigational drugs (not yet approved by the Food and Drug Administration) WNT974, LGX818 and the FDA approved drug cetuximab in people who have metastatic colorectal cancer, and whose tumor has changes in a gene called BRAF as well as in the genes called RNF43 and/or RSPO.
The study is divided into 2 parts. Subjects might be asked to participate in the first part or in the second part.
In the first part (called phase Ib), 3-6 subjects will start at the lowest planned dose of WNT974 in combination with a dose of LGX818 that has been used in other clinical studies and the approved dose for cetuximab. About 15 subjects will join in this part of the study at multiple centers around the world.
In the second part of the study (called phase II), subjects will receive the doses of medicines that have been considered to be the best combination of doses from the first part of the study. The purpose of this part of the study is to determine if the combination of these 3 medicines is effective for the treatment. About 40 subjects will join in this part of the study.
About 6 subjects will be enrolled at MUSC under the care of Dr. Carolyn Britten.

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

A Phase II Trial of Oral Pazopanib plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) without Prior Bevacizumab Exposure and (B) after Failing Prior Bevacizumab Save

Date Added
January 7th, 2015
PRO Number
Pro00030853
Researcher
Scott Lindhorst
Keywords
Brain Tumor, Cancer, Men's Health, Women's Health
Summary

The goal of this clinical research study is to learn if pazopanib when given in combination with topotecan can help to control a suhbjects glioblastoma. The safety of this drug combination will also be studied.
Pazopanib is FDA approved and commercially available for the treatment of renal cell cancer. Topotecan is FDA approved and commercially available for the treatment of lung cancer. In this study, the combination of pazopanib and topotecan is being used for research purposes only.
Up to 66 participants will be enrolled in this multicenter study. About 5 of those patients will be enrolled at MUSC under the care Dr. Giglio, MD.

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

The Effects of Statin Therapy on Brain Micro-Structure Quantified by MRI and the Relationship to Cognitive Function Save

Date Added
December 29th, 2014
PRO Number
Pro00019608
Researcher
Joseph Helpern
Keywords
Brain, Healthy Volunteer Studies, Women's Health
Summary

This study is being done to determine if the changes in cholesterol levels by the use of statins can result in changes in the brain's micro-structure. These changes are going to be studied to see if they cause changes in a person's ability to process thoughts. This study is for women between the ages of 45 and 85.

Institution
MUSC
Recruitment Contact
Rachael Deardorff
843-876-2470
deardorf@musc.edu

Exploration of Self-Care and Parenting for Adults Recovering from Substance Use Disorders (SUD) in Their Home Environment Save

Date Added
December 22nd, 2014
PRO Number
Pro00039278
Researcher
Phyllis Raynor
Keywords
Alcohol, Men's Health, Mental Health, Minorities, Non-interventional, Substance Use, Women's Health
Summary

More than 8 million children in America live with at least one parent who is dependent on alcohol or illicit drugs. Parental substance use disorder (SUD) is a major risk factor for possible adverse health outcomes for children, including increased risks of child abuse and neglect, malnutrition, poorer academic performance, behavioral and emotional problems, and child substance misuse. These findings, coupled with a national economic impact of illegal drug use estimated at $193 billion, support the need for effective parenting interventions that promote drug abstinence and long-term recovery for parents with SUD.

Many parents in recovery face overwhelming personal and environmental stressors when attempting to transition back into the parenting role from active addiction. Family dynamics and parenting relationships often suffer during and after the recovery process due to loss of income, the inability to support family, child custody disputes, fractured trust in the relationship, diminished health status of parent and child, and loss of effective parental engagement and modeling behaviors with the child. Health promotion for these parents would need to target personal and socioecological factors that foster perceived parenting capabilities (parental efficacy), resilience, parenting behaviors, and sobriety during recovery.

Many experts agree that drug misuse can result from inadequate attempts to deal with personal and environmental stressors. Individuals who have maladaptive coping or suffer from social anxiety, or stress-related conditions, and depression may begin misusing drugs in an attempt to lessen feelings of distress. Stress can be a significant factor in initiating drug use, continuing drug misuse, or relapse in individuals recovering from substance use disorders. Lack of stress modifiers such as self-care behaviors (SCB) can trigger substance misuse for recovering individuals, particularly parents. Taking care of “self” (i.e. SCB) in a way that facilitates better health outcomes in parental recovery may be a crucial part of effectively taking care of one’s children. Limited research examines SCB and its effect on parenting within the context of parental recovery. Interventions have primarily focused on drug abstinence without a specific focus on the parenting role. Although prior studies link individual stress and coping to substance misuse, and studies show positive long-term effects of resilience building measures in family-focused interventions aimed at improving child outcomes, few studies describe the relationship of SCB to parental efficacy and parenting behaviors for adults in recovery, as a basis to improve parenting interventions and supports in long term recovery. The purpose of this convergent parallel mixed-methods observational study is to determine the feasibility of a study to identify reported SCB by adult parents in long-term recovery from SUD (>2 years) who are actively parenting in their homes in the community setting as a basis for intervention development in future research. The goal of this research is to study parents in long-term recovery to learn from their experiences for use in future interventions.

Institution
MUSC
Recruitment Contact
Phyllis Raynor
803-466-5082
raynorp@musc.edu

A Multicenter Study of Ibrutinib and Lenalidomide in Combination with DA-EPOCH-R in Subjects with Relapsed or Refractory Diffuse Large B-cell Lymphoma Save

Date Added
December 9th, 2014
PRO Number
Pro00038339
Researcher
Saurabh Chhabra
Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with a form of cancer called diffuse large B-cell lymphoma (DLBCL). The investigational drug in this study is
Ibrutinib (PCI-32765) and researchers hope to learn if and how the study drugs control your cancer, how your cancer cells respond to the study drugs, the side effects of the study drugs, how long the study drugs stay in your body
and to evaluate whether special blood tests can predict how effective the study drugs will be for you. The primary purpose of this study is to learn how multiple drugs when given together work on treating DLBCL. Participants can expect to be in this study for no more than 3 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
salzers@musc.edu

An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS 003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT) Save

Date Added
December 8th, 2014
PRO Number
Pro00021461
Researcher
Harry Drabkin
Keywords
Cancer, Men's Health, Women's Health
Summary

This study is for subjects with newly diagnosed advanced kidney cancer who have previously consented to allow for collection of a tumor sample, which may be used to make a personalized experimental drug called AGS-003. Argos Therapeutics is sponsoring this research study using their experimental (investigational) drug AGS-003 to see if it is effective against kidney cancer. An investigational drug is a medication that is still being studied and has not been approved for use in the general population by the United States Food and Drug Administration (FDA). AGS-003 is made for subjects by using a piece of tumor collected after surgical removal of their kidneys along with a certain type of their own white blood cells. The resulting product is a type of immune cell called a dendritic cell, which is very good at activating the immune system against cancer cells.
AGS-003 can be used in combination with the approved, regular medications most often prescribed for the treatment of kidney cancer. In this study, one group of subjects will receive regular medications for kidney cancer and a second group will receive regular medications for kidney cancer plus AGS-003. An important purpose of this study is to see if treatment with AGS-003 plus regular medications is any different than treatment with regular medications alone. Subjects are expected to be enrolled in this study for approximately 3 years.

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

Differences in the migration and cell surface marker expression of Mesenchymal Stem Cells (MSC) obtained from the placenta and Umbilical Cord Blood Save

Date Added
November 19th, 2014
PRO Number
Pro00009198
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to determine whether there are alterations in the migration and cell surface marker expression of MSC’s obtained from the placenta and umbilical cord in uncomplicated pregnancies

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