Studies Open to Enrollment
- Alefacept: Kidney Transplant Recipients
- Aspergillosis: Invasive Infection, Aspergillus
- CORAL: Cardiovascular Disease, Atherosclerosis, Hypertension
- Cystic Fibrosis: Children (12-17 years) or Adults 18 years and older
- GIDEON: Advanced Stage Liver Cancer, Currently Taking Nexavar®
- HUMIRA: Moderate to Severe Crohn's Disease, Currently Taking Humira®
- INTENSIVE: In-patients with Anterior STEMI Undergoing PCI
- LIBRA: Euvolemic Hypotremia (normal amount of blood, but too much water and too little salt in blood)
- Maravoric: HIV-1 Infected, Maravoric-experienced
- Protect II: Coronary Artery Disease, Requiring Balloon or Stent
- SLEIGH: Observational, Systemic Lupus Erythematosus, Sea Island Community
- Tamiflu: Immunocompromised with Flu Symptoms
- VIRGO: Observational, Myocardial Infarction
- Vitamin D: Chronic Kidney Disease, Currently NOT Taking Vitamin D
Indication: Kidney Transplant Recipients
Purpose:
The purpose of this study is to determine how alefacept works as an anti-rejection medicine when used in combination with other anti-rejection medicines that are routinely used in kidney transplant patients. There are four study treatment combinations in this study.
Subject Participation:
Subjects will be required to come back to the hospital or clinic regularly for outpatient or inpatient examinations. For each subject, the study duration includes 6 months of treatment and 6 months of follow-up for a total of 12 months. There will be a total of about 21 scheduled visits during the study.
Subject Compensation:
Any drugs, tests or procedures that are required by the study, which are not part of the routine care of kidney transplant patients, will be provided free of charge. Subjects will receive travel expense reimbursement for study-related clinic visits.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00543569
Principal Investigator: Laura L. Mulloy, DO, FACP
FOR MORE INFORMATION CONTACT: Kay Bailey, RN at 706-721-9547 (kbailey@mcg.edu)
Study Short Name: Aspergillosis
Indication: Invasive Infection, Aspergillus
Purpose:
The reason for carrying out this research is to find out how taking a combination of antifungal medicines (voriconazole and anidulafungin) to treat invasive Aspergillus infections compares to taking treatment with a single medicine, voriconazole.
Subject Participation:
To be included in the study, a doctor must have a high suspicion that the subject as an invasive infection with Aspergillus. The diagnosis can be pending at the time that you enter the study. The doctor will perform testing during the study to confirm whether or not there is an infection with Aspergillus. Subjects will receive a total of 6 weeks of study treatment. The total length of the study is 12 weeks. There will be a total of about nine study visits (combination inpatient/outpatient and telephone).
Subject Compensation:
Any drugs, tests or procedures that are required by the study, which are not part of the routine care for treating Aspergillus infection, will be provided free of charge. Subjects will receive travel expense reimbursement for study-related clinic visits (four).
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00531479
Principal Investigator: Stephanie Baer, MD
FOR MORE INFORMATION CONTACT: Kiki Bush-Brown, RN at 706-721-9684 (kbushbrown@mcg.edu)
Indication: Cardiovascular Disease, Atherosclerosis, Hypertension
Purpose:
The purpose of the CORAL study is to determine the best treatment for patients who have high blood pressure and blockage of the renal artery that supplies blood to the kidney.
Subject Participation:
There are two courses of treatment is this study. One group will receive blood pressure medication only. The second group will receive blood pressure medication plus a surgically placed stent, which is used to open the blockage. Subjects will undergo a baseline evaluation to determine eligibility. Initially, subjects will be followed at 2-week intervals, until blood pressure is at target or up to 2 months. Follow-up visits will be required at 2 weeks, every 3 months for the first year and annually thereafter. Coordinator visits will also occur twice a year. The study is scheduled to follow some subjects up to 5.5 years from the time they begin participation.
Subject Compensation:
Any drugs, tests or procedures that are required by the study will be provided free of charge. Subjects will receive travel expense reimbursement for study-related clinic visits.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00081731
Principal Investigator: Laura L. Mulloy, DO, FACP
FOR MORE INFORMATION CONTACT: Kate Sideman, RN at 706-721-2617(ksideman@mcg.edu)
Study Short Name: Cystic Fibrosis
Indication: Cystic Fibrosis: Children (12 - 17 years) or Adults 18 years and older
Purpose:
Cystic Fibrosis is a disease that can cause chronic lung infections. One type of lung infection is caused by a bacteria called Pseudomonas Aeruginosa, which is commonly found in patients with cystic fibrosis. The purpose of this research study is to determine whether an experimental drug/device combination, Nektar Therapeutics’ T-326 Powder Inhaler with Ciprofloxacin PulmoSphere®, is safe and effective in the treatment of this disease, compared with placebo.
Subject Participation:
Subjects will be given either ciprofloxacin or matching placebo (a dummy substance that contains no active ingredients). During the study, subjects will have study-related tests and procedures and complete a questionnaire. Participation includes a total of eight visits to the study doctor’s office and one phone call over the next three months (up to 92 days).
Subject Compensation:
Any drugs, tests or procedures that are required by the study will be provided free of charge. Subjects will receive travel expense reimbursement for study-related clinic visits.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00645788
Principal Investigator: Caralee Forseen, MD
FOR MORE INFORMATION CONTACT: Charlene Weathers, RN at 706-721-9680 (chweathers@mcg.edu)
Indication: Advanced Stage Liver Cancer, currently taking Nexavar®
Purpose:
This is a Registry study. A Registry study is a study in which drugs are prescribed per their locally approved label indication and therapies given as part of normal clinical practice.
The main purpose of this study is to obtain further data concerning the safety and effectiveness of this drug under routine clinical conditions.
Subject Participation:
This study does not require additional visits or tests beyond those that would normally take place as part of standard care. Data from the subject’s regular clinic visit will be collected, and the treating doctor will also fill out study forms from time to time. All patients on this study will be followed indefinitely or until they have withdrawn from this study for any reason. Study data collection started at the end of 2008 and will run the end of 2013.
Subject Compensation: There is no subject compensation for participation in this data collection study.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00812175
Principal Investigator: Robert Schade, MD
FOR MORE INFORMATION CONTACT: Kate Sideman, RN at 706-721-2617 (ksideman@mcg.edu)
Indication: Moderate to Severe Crohn’s disease, currently taking HUMIRA® (adalimumab)
Purpose:
This is a Registry study. A Registry study is a study in which drugs are prescribed per their locally approved label indication and therapies given as part of normal clinical practice.
The purpose of this study is to observe the long-term safety and efficacy of HUMIRA® in the treatment of patients with moderate to severe Crohn’s disease followed while receiving routine medical care.
Subject Participation:
This study does not require additional visits or tests beyond those that would normally take place as part of standard care. Data from the subject’s regular clinic visit (12) will be collected, the treating doctor will also fill out study forms from time to time, and subjects will be asked to fill out questionnaires. Study data collection started in 2007 and will run until the end of 2014.
Subject Compensation: There is no subject compensation for participation in this data collection study.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00524537
Principal Investigator: Robert Schade, MD
FOR MORE INFORMATION CONTACT: Kate Sideman, RN at 706-721-2617 (ksideman@mcg.edu)
Indication: In-patients with anterior STEMI undergoing PCI
Purpose:
The purpose of this study is to see how two different approaches to controlling blood sugar affect the amount of tissue damage caused by a heart attack. In one approach, subjects will all receive continuous IV insulin (Apidra®) followed by insulin (Lantus®) injected under the skin, to keep the blood sugar between 90 and 130 (nearly normal) until discharge. This approach will be compared to giving insulin only as an injection under the skin, for blood sugars higher than 180.
Subject Participation:
This study consists of a three 7-day in-hospital period, followed by a 30-day office visit, 60-day office visit, and a 1 year telephone follow-up contact.
Subject Compensation:
Subjects will be reimbursed for travel and compensated for time for one phone visit and two clinic visits. The study drug and all tests, procedures and visits required by the study are provided at no cost.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00670228
Principal Investigator: Gyanendra K. Sharma, MD
FOR MORE INFORMATION CONTACT: Kiki Bush-Brown, RN at 706-721-9684 (kbushbrown@mcg.edu)
Indication: Hyponatremia (normal amount of blood, but too much water and too little salt)
Purpose:
The main purpose of this study is to find out if lixivaptan, an investigational medication, can be used to decrease the amount of extra water in the body.
Subject Participation:
This study will last approximately 2 months (60 days). After an initial in hospital period of approximately 48-72 hours, subjects will be asked to return to the clinic 6 times. Each clinic visit will take approximately 2 hours. Subjects eligible for the study will be randomly assigned (like the flip of a coin) to receive either lixivaptan or placebo (a medically inactive substance). Study procedures include labs, physical exam, and an electrocardiogram.
Subject Compensation:
Subject will receive travel compensation for research clinic visits. Study medications, tests and procedures required for the study will be at no cost to the subject.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00660959
Principal Investigator: Laura L. Mulloy, DO, FACP
FOR MORE INFORMATION CONTACT: Kay Bailey, RN at 706-721-9547 (kbailey@mcg.edu)
Indication: HIV-1 Infected, Maravoric-experienced
Purpose:
This is a Non-Interventional study. A non-interventional study is a study in which drugs are prescribed per their locally approved label indication and therapies given as part of normal clinical practice.
The purposes of this study is to find out if the use of maraviroc, along with an optimized background regimen of antiretroviral drugs in usual clinical practice, is as safe as using only an optimized regimen of antiretroviral drugs.
Subject Participation:
This study does not require additional visits or tests. Data from the subject’s regular doctor visits and medical history, as well as any tests that are conducted as part of your standard care, will be collected for up to 5 years.
Subject Compensation: Subject will receive compensation for participation in the study.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00665561
Principal Investigator: J. Peter Rissing, MD
FOR MORE INFORMATION CONTACT: Kate Sideman, RN at 706-721-2617 (ksideman@mcg.edu)
Indication: Coronary Artery Disease, Requiring Balloon or Stent
Purpose:
The purpose of this research study is to compare the safety and effectiveness of two circulatory assist devices: the IMPELLA system and the intra aortic balloon pump.
Subject Participation:
Eligible subjects will be assigned to one of two treatment groups. Before having the procedure, blood tests, special x-rays, and a physical exam will be done. Data will be collected for the study during the procedure, directly after the procedure, during the hospital stay, and at discharge. Subjects will be asked to return to the clinic 30 days after the procedure and again 3 months after the procedure. Study participation will end after the three month visit.
Subject Compensation:
Study drug and all tests, procedures and visits required by the study are provided at no cost. Subjects will not receive any compensation for study participation.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00562016
Principal Investigator: Deepak Kapoor, MD
FOR MORE INFORMATION CONTACT: Kiki Bush-Brown, RN at 706-721-9684 (kbushbrown@mcg.edu)
Indication: Observational, Systemic Lupus Erythematosus, Sea Island Community
Purpose:
In an observational study, subjects may be required to donate a blood specimen or undergo a diagnostic procedure, no treatment will be administered to them to try to change the course of their disease. In this type of study, data will be collected from the subjects through clinical testing or questionnaires.
Systemic lupus erythematosus (SLE) is a severe, disabling systemic autoimmune disease characterized by the production of autoantibodies. The clinical symptoms and immunologic manifestations of SLE are diverse. African-Americans have a 3-fold increased incidence of SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with Caucasians. The researchers believe that there are specific genetic factors that interact with environmental exposures leading to the development of SLE.
Subject Participation:
To be eligible for the study, subjects must be self-identified as African-American "Gullah" from the Sea Island region of South Carolina and have had at least 4 of the 11 diagnostic criteria for SLE, be a relative of a known SLE patient, or be an unrelated healthy Gullah control. Eligible subjects will have one visit and the total length of study participation will be one year: The initial visit will take place during your regularly scheduled clinic visit, and the one-year follow-up visit will be a telephone call. Subjects will be asked to provide an optional blood and urine sample for genetic testing.
Subject Compensation:
Tests required by the study are provided at no cost. Subjects will receive travel compensation for the initial clinic visit only.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00756769
Principal Investigator: Walter Moore, MD
FOR MORE INFORMATION CONTACT: Kiki Bush-Brown, RN at 706-721-9684 (kbushbrown@mcg.edu)
Indication: Immunocompromised With Flu Symptoms
Purpose:
The purpose of this study is to look at the safety and effectiveness of Tamiflu® (oseltamivir) in treating flu when given to subjects who have a weakened immune system (organ or stem cell transplant subjects).
Subject Participation:
Eligible subjects will be randomly assigned (by chance) to one of two study groups: conventional dose of oseltamivir for 10 days or high of oseltamivir for 10 days. Study participation will last about 40 days, and will include about seven study visits.
Subject Compensation:
Study drug and all tests, procedures and visits required by the study are provided at no cost. Subjects will receive travel expense reimbursement for study-related clinic visits
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00412737
Principal Investigator: Muralidharan Jagadeesan, MBBS
FOR MORE INFORMATION CONTACT: Kay Bailey, RN at 706-721-9547 (kbailey@mcg.edu)
Indication: Observational, Myocardial Infarction
Purpose:
In an observational study, subjects may be required to donate a blood specimen or undergo a diagnostic procedure, no treatment will be administered to them to try to change the course of their disease. In this type of study, data will be collected from the subjects through clinical testing or questionnaires.
Heart disease is one of the leading causes of death in women 55 years and younger, accounting for more than 8,000 deaths each year in the United States. Approximately 40,000 young women are hospitalized each year in the United States as a result of a heart attack. Research has shown that young women who have heart attacks are twice as likely to die in the hospital as young men who have heart attacks. This study will analyze the biologic, demographic, psychosocial, environmental, and behavioral factors that may contribute to premature heart disease and to poor recovery after a heart attack in women. Researchers will examine if delays in receiving medical care following a heart attack can affect recovery and health outcomes for women. Gender differences in outcomes and the quality of medical care that is received following a heart attack will also be examined.
Subject Participation:
This study will enroll women and men who are hospitalized following a possible heart attack. At study entry, participants will be interviewed to collect information about symptoms, functioning, quality of life, and medical care. A blood collection and medical record review will also occur. At a Month 1 follow-up visit, a blood collection and interview will occur during either a medical clinic, home, or workplace visit. A telephone interview will occur at Year 1. Participants' blood samples will be stored for future biologic and genetic studies.
Subject Compensation:
The blood draw required by the study are provided at no cost. Subjects will receive minor expenses associated with the blood draw. No further compensation will be available.
Clinicaltrials.gov identifier: www.clinicaltrials.gov NCT00597922
Principal Investigator: Mindy Gentry, MD
FOR MORE INFORMATION CONTACT: Kate Sideman, RN at 706-721-2617 (ksideman@mcg.edu)
Indication: Chronic Kidney Disease, Currently NOT Taking Vitamin D
Purpose:
The purpose of the research protocol is to find out the effect of doxercalciferol (a man-made form of vitamin D) on markers of inflammation, endothelial function, and oxidative stress in patients with Stage 3 and 4 chronic kidney disease (CKD).
Subject Participation:
Subject your length of participation will be about 90 days (three months). There will be three study visits: blood and urine collected three times, one bone density test, and two studies on your arteries called flow mediated dilatation (FMD) with ultrasound and nitroglycerin during this study.
Subject Compensation:
Subjects will receive a 90-day supply of study medication free of charge. Subjects will receive travel reimbursement for three clinic visits. No further compensation will be made.
Clinicaltrials.gov identifier: Not Available.
Principal Investigator: John J. White, MD
FOR MORE INFORMATION CONTACT: Charlene Weathers, RN at 706-721-9680 (chweathers@mcg.edu)
OCIS Study Coordination Services
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