Smart Capsule for Automatic Adherence Monitoring Save

Date Added
January 7th, 2014
PRO Number
Pro00030913
Researcher
Aimee Mc Rae
Keywords
Drug Studies, Non-interventional, Substance Use
Summary

Approximately 60 healthy male and female patients, ages 18 to 65, will participate in this study. The primary objective of the study is to evaluate the acceptability, tolerability, and efficacy of administering medication capsules with built-in, ingestible computer chips to healthy people. The primary outcome will be medication compliance as measured by the proportion of days adherent to taking medication over a 28-day period.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients with Stable, Quiescent Systemic Lupus Erythematosus (SLE) Save

Date Added
December 17th, 2013
PRO Number
Pro00028738
Researcher
Diane Kamen
Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

This study is designed to look at the safety of taking patients whose lupus is not active off the immune suppression medication, Mycophenolate. It will involve two groups of lupus patients. One group will continue taking Mycophenolate Mofetil (MMF), and the other group will taper off their MMF. Both groups will be followed closely by study doctors to determine their lupus activity levels over the course of 16 months.

Institution
MUSC
Recruitment Contact
Margaret Lindemuth
843-792-8613
hardinm@musc.edu

An Open Label study to examine the effects of DAS181 administered by Nebulized formulation in Immunocompromised subjects with Parainfluenza (PIV) Infection post study participation in PIV protocol DAS181-2-05 Save

Date Added
December 10th, 2013
PRO Number
Pro00029144
Researcher
Michelle Hudspeth
Keywords
Drug Studies, Immune System, Pediatrics, Pulmonary
Summary

The purpose of this research study is to test the safety, effectiveness and tolerability of an investigational drug called DAS181 on subjects with a very weak immune system who are diagnosed with PIV. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). DAS181 can be administered as a reconstituted dry powder that is breathed into the respiratory tract (nose, throat and lungs) using a liquid aerosol spray administered using a nebulizer. A nebulizer is an electrically powered machine that turns liquid medication into a mist so that it can be breathed directly into the lungs through a face mask or mouthpiece.

Institution
MUSC
Recruitment Contact
Mohammed Al Gadban
843-792-4837
algadban@musc.edu

A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma Save

Date Added
September 19th, 2013
PRO Number
Pro00029068
Researcher
James Bearden
Keywords
Cancer, Cancer/Brain, Drug Studies
Summary

The purpose of this study is to:
? See if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in patients who have been diagnosed with cancer and are experiencing fatigue.
? See the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue.

In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent). They will not take both.

Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders. However, it is not been studied in people with cancer related fatigue.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

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
August 27th, 2013
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

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 Save

Date Added
August 19th, 2013
PRO Number
Pro00027510
Researcher
David Marshall
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
Seth Price
843-792-6969
pricesr@musc.edu

Intergroup Randomized Phase II Four Arm Study In Patients With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab + Bendamustine Followed By Rituximab Consolidation (RB? R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV? R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB ? LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV ? LR) Save

Date Added
June 20th, 2013
PRO Number
Pro00026391
Researcher
Asim Pati
Keywords
Cancer, Cancer/Lymphoma, Drug Studies
Summary

The purpose of this study is two-fold and has two steps of treatment:
1) In step 1, to find out what effects, good and bad, the addition of bortezomib to rituximab plus bendamustine has on subjects and their lymphoma compared to rituximab plus bendamustine alone.
2) In step 2, to find out what effects, good and bad, continuing treatment after step 1 with lenalidomide plus rituximab has on subjects and their lymphoma compared to continuing treatment with rituximab alone.
Subjects will receive one of the following regimens:
1) Step 1 rituximab plus bendamustine, followed by step 2 rituximab
2) Step 1 bortezomib plus rituximab plus bendamustine, followed by step 2 rituximab
3) Step 1 rituximab plus bendamustine, followed by step 2 lenalidomide plus rituximab.
4) Step 1 bortezomib plus rituximab plus bendamustine, followed by step 2 lenalidomide plus rituximab
These regimens are experimental and have not been approved by the FDA for use in patients with untreated mantle cell lymphoma, although each of the drugs used in the study is FDA approved for certain blood cancers.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A Phase II Trial Evaluating Cisplatin (NSC#119875) and Gemcitabine (NSC #613327) Concurrent with Intensity-Modulated Radiation Therapy (IMRT) in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva Save

Date Added
May 23rd, 2013
PRO Number
Pro00025562
Researcher
David Griffin
Keywords
Cancer, Cancer/Gynecological, Drug Studies
Summary

The purpose of this study is to find out if radiation therapy along with the addition of the drugs, cisplatin and gemcitabine, works in treating locally advanced squamous cell carcinoma of the vulva and to find out what side effects or surgical complications are caused by treatment with this combination.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

Phase II Randomized Study of Whole Brain Radiotherapy in Combination with Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer ? A COLLABORATIVE STUDY OF RTOG AND KROG Save

Date Added
May 7th, 2013
PRO Number
Pro00025233
Researcher
Patricia Griffin
Keywords
Cancer, Cancer/Brain, Drug Studies
Summary

The purpose of this study is to compare the effects of adding lapatinib to standard whole brain radiation therapy (WBRT). The study will try to find out whether WBRT or lapatinib plus WBRT is better at safely improving tumor control. In this study, subjects will receive either lapatinib plus WBRT or WBRT alone.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

RANDOMIZED PHASE II TRIAL OF CONCURRENT BEVACIZUMAB AND RE-IRRADIATION VERSUS BEVACIZUMAB ALONE AS TREATMENT FOR RECURRENT GLIOBLASTOMA Save

Date Added
March 19th, 2013
PRO Number
Pro00023155
Researcher
Scott Lindhorst
Keywords
Cancer, Cancer/Brain, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have a brain tumor, called a glioblastoma or gliosarcoma, which has become worse after previous treatment. The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastomas.
In this trial patients will be randomly assigned to receive either bevacizumab alone or bevacizumab and radiation therapy.If you are in Group 1, you will be asked to take bevacizumab alone every two weeks as long as it is working and there are no intolerable side effects. If patients are assigned to Group 2, he/she will take bevacizumab 2 weeks before radiation therapy, during radiation therapy, and then every 2 weeks after radiation therapy as long as it is working and there are no intolerable side effects. The radiation will be given to participants over 2 weeks. Participants will be followed every 8 weeks while on treatment and then also if participants are removed from protocol treatment. Follow-up will continue every 8 weeks for 1 year, then every 6 months for 1 year, then annually.

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

Change_preferences

-- OR --

Create_login