A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Date Added
April 30th, 2014
PRO Number
Pro00034096
Researcher
Whitney Graybill

List of Studies


Keywords
Cancer/Gynecological, Women's Health
Summary

This study is for adult women who have advanced or recurrent endometrial (uterine) cancer. The purpose is to find out if the drug combination of paclitaxel, carboplatin and metformin works better than paclitaxel and carboplatin alone in treating uterine cancer.

Institution
MUSC
Recruitment Contact
Sarah Booker
843-792-9190
bookers@musc.edu

A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer.

Date Added
April 28th, 2014
PRO Number
Pro00034803
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for patients that have prostate cancer that has spread and are either beginning hormone therapy for the first time or have been on hormone therapy for less than 30 days. The purpose of this study is to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone. The combination of TAK-700 and standard hormone therapy is considered experimental.

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

A RANDOMIZED PHASE III STUDY OF BENDAMUSTINE PLUS RITUXIMAB VERSUS IBRUTINIB PLUS RITUXIMAB VERSUS IBRUTINIB ALONE IN UNTREATED OLDER PATIENTS (≥ 65 YEARS OF AGE) WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

Date Added
April 4th, 2014
PRO Number
Pro00033691
Researcher
Brian Hess

List of Studies


Keywords
Cancer/Leukemia
Summary

This study is for male and female patients who are 65 years of age or older who have chronic lymphocytic leukemia (CLL) that has never been treated before, and their disease has progressed to the point that therapy has been recommended. The purpose of this study is to compare the effects, good and/or bad, of the drug ibrutinib, either alone or in combination with the drug rituximab, with the standard treatment for this disease. The standard treatment is chemotherapy with the drug bendamustine in combination with the drug rituximab. The effects on the patient and their leukemia will be looked at to find out which treatment is better. Both bendamustine and rituximab are approved by the FDA to treat chronic lymphocytic leukemia (your leukemia type), but ibrutinib is considered investigational. In this study, patients will get either the drug ibrutinib alone, or ibrutinib with rituximab, or bendamustine with rituximab. If the patient is in the group that receives bendamustine with rituximab and their disease returns, they will have the option to receive ibrutinib.

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

Validation of computer-based saccade measures as a sensitive, reliable, and freely available biomarker for tracking subtle neurocognitive changes in Parkinson's disease

Date Added
March 28th, 2014
PRO Number
Pro00031260
Researcher
Travis Turner

List of Studies


Keywords
Parkinsons
Summary

We will ask 80 patients with Parkinson's disease, representing the full spectrum of motor and cognitive symptoms, to participate. Participation will include measurement of eye movements using two methods: the new computer-based saccade battery and the best available video-based eye-tracking equipment. The evaluation will be repeated about 30 days later. Data will be analyzed to determine whether the computer-based tasks are reliable and able to provide the same quality of information as the gold standard in eye-tracking. A comparison sample of 80 healthy older adults will also complete the behavioral saccade tests in order to establish normative data that will enable application in clinical settings.

Institution
MUSC
Recruitment Contact
Travis Turner
619-788-3079
turnertr@musc.edu

Regulation of Inflammatory T Cells and Neuroprotection by Calpain Inhibition in MS

Date Added
March 4th, 2014
PRO Number
Pro00028348
Researcher
Narendra Banik

List of Studies


Keywords
Inflammation, Multiple Sclerosis
Summary

A number of veterans suffer from multiple sclerosis (MS), a devastating and debilitating disease for which there is not cure or significant treatment. The only therapy available is immunomodulatory, but does not treat the neurodegeneration. The studies proposed in this application will develop therapeutic strategies and identify a drug that ameliorates inflammation as well as neurodegeneration in the disease. Thus, the effect of this drug will not only help veterans with MS, but will also benefit individuals with the disease in general.

Institution
MUSC
Recruitment Contact
Elizabeth Kau
789-6450
elizabeth.kau2@va.gov

An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes

Date Added
February 18th, 2014
PRO Number
Pro00030914
Researcher
Richard Friedman

List of Studies


Keywords
Joint, Pain, Surgery
Summary

The purpose of this study is to collect and evaluate clinical and radiographic outcomes data on patients who have undergone, or will undergo, shoulder replacement surgery. Patients who receive a device from the Equinoxe® Shoulder System, manufactured and distributed by Exactech, Inc as well as patients who receive a device from another shoulder arthroplasty system may be included in this study.

Institution
MUSC
Recruitment Contact
Lisa Mock
843-876-2211
mockl@musc.edu

Assessment of Contributions to Impaired Walking after Neurologic Injury

Date Added
January 15th, 2014
PRO Number
Pro00028941
Researcher
Chris Gregory

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Muscle, Nerve, Physical Therapy, Rehabilitation Studies, Stroke
Summary

Rehabilitation interventions including resistance training, functional and task-specific therapy, and gait or locomotor training have been shown to be successful in improving motor function in individuals with neurologic disease or injury. Recent investigations conducted in our laboratory indicate that intense resistance training coupled with task-specific functional training lead to significant gains in functional motor recovery. Similarly, gait rehabilitation involving intense treadmill training and/or task-specific locomotor training has been shown to be effective in improving locomotor ability. However, the underlying neural adaptations associated with these therapeutic approaches are not well understood. Our primary goal is to understand the motor control underpinnings of neurologic rehabilitation in order to apply this knowledge to future generations of therapeutic interventions.

Institution
MUSC
Recruitment Contact
Brian Cence
843-792-2668
cence@musc.edu

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High-Risk Prostate Cancer: A Phase III Randomized Trial

Date Added
September 17th, 2013
PRO Number
Pro00028856
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area to determine which is better.

There are 2 treatment groups in this study:
1) Patients who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles
2) Patients who receive hormone therapy plus radiation therapy to the whole pelvis

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

ACNS1022: A Phase II Randomized Trial of Lenalidomide (NSC # 703813, IND # 70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytoma and Optic Pathway Gliomas

Date Added
August 23rd, 2013
PRO Number
Pro00026888
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

The overall goal of this study is to find out what effects, good and/or bad, a low
dose and a high dose of lenalidomide have on children, adolescents and young
adults with recurrent (has come back after being treated), refractory (has not gone
away with previous treatment), or progressive (is not responding to previous
treatments) Juvenile Pilocytic Astrocytomas (JPA) and Optic Pathway Gliomas
(OPG).

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

A Phase III Prospective Randomized Trial Of Dose-Escalated Radiotherapy With Or Without Short-Term Androgen Deprivation Therapy For Patients With Intermediate-Risk Prostate Cancer

Date Added
August 19th, 2013
PRO Number
Pro00027510
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Prostate
Summary

This study is for patients with prostate cancer. The purpose of this study is to compare the effects of dose-escalated radiation therapy with or without hormone therapy on your prostate cancer.
There are 2 treatment groups in this study:
1) Patients who receive radiation therapy only
2) Patients who receive radiation therapy plus hormone therapy
Patients will receive 44 radiation treatments over approximately 2 months. If the patient chooses to receive the brachytherapy implant, he will receive 25 daily treatments plus the implant procedure over a timeframe of approximately 6 weeks. Hormone therapy, if given, will last 6 months. After patients are finished receiving therapy, the study doctor will ask them to visit the office for follow-up exams at 3, 6, 9, and 12 months after finishing radiation treatment, every 6 months for 4 years, and yearly thereafter.

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



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