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Filter by:This is an open label, single-center, randomized phase IV pilot study of steroid and calcineurin inhibitor avoidance in renal transplant recipients. All patients will receive two doses of alemtuzumab to achieve peripheral T-cell depletion. Intravenous glucocorticoids will be administered prior to alemtuzumab administration to limit cytokine release syndrome in association with this monoclonal antibody, and continued for the first two days post-transplant. Thereafter, steroids will not be used for immunosuppression. All transplant recipients will be started on oral immunosuppressive therapy with mycophenolate mofetil (MMF) prior to transplant. Pretransplant, these patients will be randomized to receive, in addition, either tacrolimus (Tac) or sirolimus. After six months, patients in the tacrolimus arm who do not experience rejection will be randomized to continue on tacrolimus or to be converted to the combination of sirolimus and MMF. Individuals in this arm of the study who do not experience acute rejection, and demonstrate evidence of donor specific hyporesponsiveness at 9 months post-transplant (those staying on Tac + MMF) or 3 months post-conversion (those converted from Tac + MMF to sirolimus + MMF) will be weaned to MMF monotherapy. Individuals in the sirolimus + MMF arm who do not experience acute rejection and demonstrate evidence of donor specific hyporesponsiveness at 6 months post-transplant will be weaned to MMF monotherapy.
The normal heart has four chambers. There are two upper (or filling) chambers and are called the atrium. There are two lower (or pumping) chambers and are called the ventricles. One of the ventricles pumps blood to the lungs to get oxygen. This oxygenated blood is returned to the heart then pumped to the rest of the body by the other ventricle. Sometimes babies are born with heart defects that only allow one of the lower chambers (ventricle) to work properly. This means that the one ventricle must pump blood to both the lungs and to the rest of the body. Babies born with this defect must undergo multiple surgeries, the first of which is usually done during their first week of life. There is a machine that is FDA approved that can measure how much oxygen is delivered to the brain. This non-invasive (outside the body) machine uses Near-infrared spectroscopy (NIRS), which is similar technology used in pulse oximetry and is routinely used to measure the level of oxygen in blood. At Children's Healthcare of Atlanta, we typically place the NIRS machine on the baby in the Cardiac Intensive Care Unit immediately after their first surgery to monitor oxygen delivery to the brain. The monitor has proven to be accurate in this situation. We now want to know if we can use this monitor to assess oxygen delivery to the brain before and during a routine heart catheterization prior to the child's second surgery. Once consent is obtained, we will place a probe on the child's forehead during the pre-catheterization visit and obtain readings for 5 minutes. The probes are about the size of a quarter and are self-stick (they look like the kind of leads used to measure the babies heart rate [EKG]). The machine will be disconnected for the rest of the Pre-catheterization visit, however the probes will stay on the child's forehead. Once the child is in the catheterization suite, the machine will be reconnected. A sheath or hollow tube is routinely placed in a blood vessel in the child's neck or groin for the catheterization. The doctor would place a special catheter in this sheath that measures oxygen levels in blood continuously. This monitor would be calibrated by using the results of a blood sample that is routinely drawn from the child's IV. During the same sampling, an additional 2cc's of blood would be collected to measure the lactate level. The lactate level is an indicator of how well the child is using oxygen. Once this monitor is calibrated, data will be collected for 5 minutes to compare it with the NIRS machine. The special catheter will be removed after the 5-minute time period, and the catheterization will proceed as usual. The NIRS probes will stay on the child's forehead during the entire catheterization with the data documented. At the end of the catheterization, the probes will be removed.
Patients who are at least 18 years of age and have a type of cancer known as advanced non-small cell lung cancer may be eligible for this study if they meet all of the inclusion/exclusion criteria. Background: The standard treatment for patients with advanced non-small cell cancer is chemotherapy. The two drug combination, carboplatin (Paraplatin) and paclitaxel (Taxol), is commonly used as the first treatment. Unfortunately, standard treatment with chemotherapy only shrinks the cancer in about 30% of patients that receive it. There is no way to predict who will or won't benefit from this treatment. The researchers at the University of Michigan would like to determine if the genes of the lung cancers in patients enrolled in this study will help predict whether or not the tumors shrink when exposed to standard chemotherapy. The goal is to find a set of lung cancer genes that will predict successful treatment with carboplatin and paclitaxel in patients with non-small cell lung cancer. The actual treatment, carboplatin and paclitaxel, involved in this study is not experimental. The experimental aspect of this study is the identification of predictors of response to treatment. To do this, it would require a sample of your cancer. If your initial surgery or biopsy was done at the University of Michigan, we may already have an adequate sample of your cancer that could be used for this research. In that case, we are asking for your permission to use this sample for this study. However, if you meet all eligibility criteria and agree to participate in this research study and an adequate sample is not available, you will need to undergo another biopsy procedure for us to obtain a sample of your cancer. Obtaining a tumor sample is the most crucial part of this research study.
This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimer's type.
Cardiac surgery using heart and lung machine produces an inflammatory reaction in the body. This leads in few percent of cases to heart, lung, and kidney disturbances that potentially causes death. White blood cells in contact with the heart and lung machine and external surfaces release mediators partly responsible for this. Blood collected by the suction and the blood remaining in the heart and lung machine after its use, can be cleaned by a cell saver before reinfusion, and this might reduce the inflammatory response.
The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.
The prevention of graft rejection after liver transplantation benefits nowadays from a variety of newly developed immunosuppressive agents. This allows more flexible and individualized immunoprophylaxis and gives an opportunity to reduce the long-term side effects (hypertension, renal failure, diabetes, etc.) of immunosuppression. The purpose of this study is to evaluate, in liver transplanted patients, if low doses of tacrolimus, given in combination with mycophenolate mofetil, can result in a lower rate of long-term side effects without increasing the rate of graft rejection.
This is a registry-based observational study assessing clinical outcomes in FAP patients receiving celecoxib compared with historical/concurrent registry patients who have not received celecoxib. Both retrospective and prospective data will be utilized. No sampling methods apply.
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.
The aim of this randomized study is to compare the effect of pioglitazone versus placebo on change in limb fat in HIV 1-infected patients treated with antiretroviral therapy for at least 6 months and with clinical lipoatrophy.