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NCT00011505
This study will provide information needed to develop more effective treatments for patients with Diamond-Blackfan anemia (DBA). Current treatments include steroids, such as prednisone, and blood transfusions. These treatments have potential long-term risk and side effects, including osteoporosis and impaired growth from steroids or iron overload from transfusions. In addition, as patients reach adulthood, they can develop acute leukemia or bone marrow failure. The only cure for DBA is bone marrow transplant, a procedure that itself carries serious risks and is an option for only about 25 percent of patients. DBA is caused by a mutation (error) in a gene that codes for producing red blood cells from stem cells (blood-forming cells produced by the bone marrow). In 5 to 10 years, gene transfer therapy may prove to be an effective treatment for DBA. Before this treatment can be considered, however, more information is needed about DBA patients and how their stem cells function. This study will examine: 1) whether stem cells of patients with DBA respond to G-CSF the same way those of healthy people do. (G-CSF is a drug that causes stem cells to move from the bone marrow to the blood stream, where they can be collected more easily and in larger numbers by a procedure called leukapheresis, described below. If G-CSF does not work well in DBA patients, other collection strategies will have to be explored); and 2) whether the genetic error in DBA can be corrected by gene transfer into patients' stem cells. Patients with Diamond-Blackfan anemia 4 years of age and older who weigh at least 27 pounds and who are dependent on red blood cell transfusions may be eligible for this study. Candidates will have a medical history taken and a physical examination and will be seen by the Clinical Center's Department of Medicine Transfusion for leukapheresis evaluation. They will have a bone marrow aspiration and biopsy to confirm the diagnosis of DBA. For these tests, the hip area is anesthetized and a needle is used to draw bone marrow from the hipbone. If needed, the procedure will be done under sedation. Patients will be given G-CSF by injection under the skin for up to 6 days. Blood and stem cell counts will be measured from a teaspoon of blood drawn each morning. On the morning of the fifth dose, the patient will undergo leukapheresis for collection of stem cells. For this procedure, a large catheter (with a diameter no larger than that of a straw) is placed in an arm vein to allow blood to flow into a cell separator machine. Most children and some adults do not have veins large and strong enough for this tubing, so a large intravenous line called a "central line" is placed into a large vein in the neck or groin. This is done under sedation and with a local anesthetic. While the patient lies on a bed or recliner, whole blood is collected through a catheter in one arm or the central line, the stem cells are separated out by spinning, then the red cells, platelets and plasma are returned through a second catheter in the other arm or a second opening in the central line. The procedure takes about 3 to 5 hours, during which the patient can watch television or videos and have family members at the bedside for company. When the procedure is completed, the patient's participation in the protocol ends. Some of the stem cells collected by leukapheresis will be used for research and some will be frozen and stored for possible future transplantation into the patient, if required.
NCT00011856
This study will investigate cerebral (brain) aneurysms and their possible inheritance patterns in families. It will try to determine how often brain aneurysms occur in families in which more than one member has had an aneurysm and to find the gene or genes that contribute to their development. People in families in which more than one family member had a cerebral aneurysm are eligible for this 1-day study. They will undergo the following procedures: * Blood will be drawn (no more than 3 to 4 tablespoons) for research to identify genes that contribute to the development of brain aneurysms. * A magnetic resonance angiograph (MRA) scan will be done to examine a specific brain area where aneurysms typically occur. Magnetic resonance imaging uses a strong magnetic field and radio waves to produce images of the brain and detect abnormalities. If a more detailed picture of the brain is needed than can be obtained with MRA, a more specific MRA scan will be done using a contrast dye to enhance the images. Patients may be invited to participate in related NIH research studies.
NCT00006077
This study will evaluate the effects of an experimental drug called NS2330 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. This drug prevents the neurotransmitter dopamine from entering nerve cells. Patients between 18 and 75 years old who have moderately advanced Parkinson's disease and motor problems resulting from levodopa therapy may be eligible for this 5-week study. Candidates will have a complete medical history and physical examination with a detailed neurological evaluation. If needed, some patients will undergo a magnetic resonance imaging (MRI) or computerized tomography (CT) scan of the brain and a chest X-ray. All patients will have blood and urine tests and an electrocardiogram (EKG) and will take a written test for evaluation of depression. Patients enrolled in the study will, if possible, stop taking all antiparkinson medications except levodopa (Sinemet) for one month before the study begins and through its duration. For the first 1 to 3 days, patients will undergo a levodopa "dose-finding" procedure. For this study, patients will stop taking their usual oral levodopa medicine and instead will have levodopa infused through a vein for up to 12 hours. During the infusions, the drug dose will be increased slowly until either 1) parkinsonism symptoms improve, 2) dyskinesias appear, 3) unacceptable side effects occur, or 4) the maximum study dose is reached. When the patient's optimal dose is determined, treatment will begin. Patients will take three pills containing NS2330 or placebo (a look-alike pill with no active ingredient) 3 days a week for up to 5 weeks, in addition to their regular levodopa medication. All participants will receive placebo at some point in the study; some patients will receive only placebo throughout the entire 5 weeks. On treatment days, patients will have a brief medical examination before receiving the drug and will then be monitored for side effects for about 6 to 8 hours after taking the drug. At the beginning of weeks 2 and 5, the levodopa infusions will be repeated at the previously determined optimum rate. Throughout the study, parkinsonism symptoms, dyskinesias and depression will be evaluated. Blood and urine samples will be collected each week for standard safety tests, and blood will also be drawn periodically to measure NS2330 levels.
NCT00047957
This study will use transcranial magnetic stimulation, or TMS (described below), to examine how the brain controls muscle movement to prevent unwanted movements in surrounding muscles. For example, when a person moves a finger, a part of the brain called the cortex prevents unwanted movements in other fingers by a process called cortical inhibition. In people with the muscle disorder dystonia, cortical inhibition does not work properly and patients suffer from uncontrolled and sometimes painful movements. A better understanding of how this process works in normal people may shed light on what goes wrong in dystonia and how the condition can be treated. Healthy normal volunteers 19 years of age and older may be eligible for this study. Candidates will be screened with a medical history and physical and neurological examinations. People with a current medical or surgical condition or neurological or psychiatric illness may not participate, nor may individuals who are taking medication that may influence nervous system function. Participants will undergo TMS to record the electrical activity of muscles in the hand and arm that are activated by magnetic stimulation. For the procedure, subjects are seated in a chair with their hands placed on a pillow in their laps. A wire coil in placed on their scalps. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. Subjects will be asked to move their second finger in response to a loud beep or visual cue. In some trials, a brief, mild electrical shock will also be applied to the end of either the second or fifth finger. The shock is not painful. TMS may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may induce twitches or temporary tingling in the forearm, head, or face muscles. The twitching may cause mild discomfort, but the procedure is rarely considered painful.
NCT00005936
This study will examine liver tissue to investigate the role of viral infections in fulminant hepatitis, liver failure, and profound bone marrow failure. All patients who are undergoing liver biopsy or liver transplantation may participate in this study. For patients undergoing liver biopsy, a small piece of liver tissue will be taken from the sample collected during the scheduled biopsy. For patients undergoing liver transplantation, a small piece of tissue will be collected from the diseased liver that is to be removed.
NCT00006202
This study will examine whether taking the vitamin lutein changes lutein blood levels. Lutein, vitamin C, vitamin E and beta-carotene may be useful in treating the eye disease age-related macular degeneration, but more information is needed to support this. Age-related macular degeneration can significantly impair the ability to read, drive, and carry out daily activities. It is the most common cause of vision loss in people over age 60. Lutein a carotenoid that occurs naturally in the retina (the back part of the eye), especially the macula-the part of the retina that is important for fine, detailed vision. Men and women 60 years of age and older, with or without age-related macular degeneration, may be eligible for this study. Candidates will undergo the following tests: 1. Medical history and physical examination. 2. Eye examination-Includes evaluation of visual acuity, measurement of eye pressure, examination of the lens, retina, pupils and eye movements, and photographs of the eye. 3. Visual field study-Examines the ability to see objects in the periphery. The subject looks at a target on a screen and indicates when lights that appear in other places on the screen are visible. 4. Flicker photometry-The subject looks at a flashing light and turns a knob until the light stops flashing. 5. Blood tests-To measure blood levels of lutein and other carotenoids, liver function, cholesterol and triglycerides. Participants will be randomly assigned to take one of three dosages of lutein (2.5 milligrams, 5 milligrams or 10 milligrams) for 6 months and will be examined at follow-up visits scheduled 1, 3, 6, 9 and 12 months after starting lutein. During these visits, many of the exams described above will be repeated to evaluate the effects of lutein treatment on the eye.
NCT00001677
The safety profile and efficacy of combination therapy will be evaluated using methotrexate (MTX) and the nucleoside analog fludarabine in 40 patients with severe refractory rheumatoid arthritis. The patients enrolled will be those who have experienced inadequate disease control with MTX alone or in combination with other immunosuppressive drugs such as sulfasalazine (SSZ), cyclosporin A (CsA), or hydroxychloroquine (HCQ). In this randomized, double-blind, placebo controlled trial, patients will be maintained on oral MTX at 17.5 mg/week to which either placebo or subcutaneous fludarabine at 30 mg/m(2) daily for three consecutive days per month will be added for four months. The fludarabine (or placebo) treatment period will be followed by two months of follow-up, at which time patients will be evaluated for response. Patients will be monitored for adverse effects/tolerability, disease activity, and changes in synovial volume as measured by magnetic resonance imaging (MRI). Additionally synovial biopsies will be obtained before and after treatment for investigation of infiltrating cell numbers and phenotypes, cytokine profiles, Th1 versus Th2 responses, and angiogenesis.
NCT00006276
This study will evaluate the safety and effectiveness of micellar paclitaxel for treating severe psoriasis. Paclitaxel in another formulation (Taxol) is approved by the Food and Drug Administration for use in patients with cancer. This drug can decrease growth of cancer cells and of new blood vessels. Because patients with psoriasis have an increase in skin cell and blood vessel growth, paclitaxel may also improve their condition. The dose of drug used in this study is much lower than those used to treat cancer patients and is expected to cause relatively few side effects. Patients 18 to 70 years of age with psoriasis lesions affecting at least 20% of their skin may be eligible for this study. Candidates will be screened with a history and physical examination, blood and urine tests, electrocardiogram, and possibly an exercise stress test. Participants will receive six intravenous (through a vein) infusions of paclitaxel over a 6-month period. Each infusion will take about 2 hours. Patients will stay in the clinic for observation for at least 1 hour before going home and will return to the clinic for follow-up examination and tests one week after each infusion. However, on weeks 0 and 8 visit will last for approximately 8 hours and will require a return to the clinic the following morning. Blood collection will be performed during the week 0 and 8 visits to determine how fast Micellar Paclitaxel is eliminated from your body. Approximately 2 teaspoons of blood will be taken prior to the infusion, twice during the infusion, and eight times during the 22 hours following the infusion for a total of eleven samples. These return visits will last approximately 1-2 hours. Patients will have the following procedures: 1. A skin biopsy (removal of a small tissue sample for microscopic examination) will be done at the first visit (week 0) and again at weeks 6, 14 and 22. The area of the biopsy will be numbed with an anesthetic, and a small circle of skin about the width of a pencil eraser and half as deep will be cut and lifted away. Stitches will be placed and removed 1 to 2 weeks later. 2. A history and physical examination will be done at every visit. Patients will be interviewed about changes in their skin condition and about treatment side effects and will be examined by a nurse or physician. 3. Blood and urine samples will be collected at frequent intervals (nearly every visit) to test for side effects. 4. Photographs of the skin will be taken at the first visit and at several later visits to document changes in psoriasis. 5. A blood sample will be drawn for genetic testing to look for gene changes in people with psoriasis. 6. An electrocardiogram will be taken at the last visit. This will be done at week 24 and compared to the screening EKG. 7. Gonadal toxicity monitoring will be started with all patients entered into the protocol as of May 2001. Blood will be drawn to measure Inhibit A for females and Inhibit B for males at weeks 0, 6, 14, and 22.
NCT00006336
This study will examine the effectiveness of Braille reading as a sensory training program for improving symptoms of focal (localized) dystonia, a movement disorder caused by sustained muscle contractions. Musicians, writers, typists, athletes and others whose work involves frequent repetitive movements may develop focal dystonia of the hand. Dystonia patients have an impaired sense of touch, and it is thought that symptoms may improve with sensory tactile (touch) training. Patients with task-specific dystonia and healthy normal volunteers may be eligible for this 8-week study. Patients will undergo evaluation of their dystonia and a complete neurologic examination. Healthy volunteers will have a complete physical examination. On the first day of the study, after 4 weeks and after 8 weeks, all participants will have a gap detection test for sensory perception testing. The test uses eight plastic devices called JVP-Domes with ridges of different widths on the surface. The subject's arm and hand are held in palm-up position and the right index finger is tested for about 1 second 20 times with each dome. The subject is asked to report whether the direction of the dome is vertical or horizontal. The test takes about 30 minutes. Patients with dystonia will also have a their symptoms evaluated at these visits. The evaluation involves completing a written questionnaire and writing a paragraph. All participants will be trained in Braille reading at NIH. Sessions will be given every day the first week, twice a week the second and third weeks, and once a week the following weeks.
NCT00029601
This study will use transcranial magnetic stimulation (TMS) to examine how the brain controls muscle movement in dystonia. Dystonia is a movement disorder in which involuntary muscle contractions cause uncontrolled twisting and repetitive movement or abnormal postures. Dystonia may be focal, involving just one region of the body, such as the hand, neck or face. Focal dystonia usually begins in adulthood. Generalized dystonia, on the other hand, generally begins in childhood or adolescence. Symptoms begin in one area and then become more widespread. Healthy normal volunteers and patients with focal \[or generalized\] dystonia \[between 21 and 65 years of age\] may be eligible for this study. Participants will have transcranial magnetic stimulation. For this test, subjects are seated in a comfortable chair, with their hands placed on a pillow on their lap. An insulated wire coil is placed on the scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. (This may cause muscle, hand or arm twitching if the coil is near the part of the brain that controls movement, or it may induce twitches or transient tingling in the forearm, head or face muscles.) During the stimulation, subjects will be asked to either keep their hand relaxed or move a certain part of the hand in response to a loud beep or visual cue. Metal electrodes will be taped to the skin over the muscle for computer recording of the electrical activity of the hand and arm muscles activated by the stimulation. There are three parts to the study, each lasting 2-3 hours and each performed on a separate day.
NCT00006337
This study will evaluate the effects of an experimental drug called KW-6002 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. This drug blocks the action of the neurotransmitter adenosine, thought to be involved in producing Parkinson's symptoms. Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 80 years of age may be eligible for this 7-week study. Participants will have a complete medical history and physical examination, including blood tests and an electrocardiogram, and possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray. Patients enrolled in the study will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. For the first 1 to 3 days, patients will be admitted to the NIH Clinical center to undergo a levodopa "dose-finding" procedure. For this study, patients will stop taking Sinemet and instead will have levodopa infused through a vein for up to 8 hours/day. During the infusions, the drug dose will be increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Symptoms will be monitored frequently to find two infusion rates: 1) one that is less than what is needed to relieve symptoms, and 2) one that relieves symptoms but may produce dyskinesias. This procedure will be repeated at the end of weeks 2, 4 and 6 of the study. When the patient's optimal dose is determined treatment will begin. Patients will take tablets or capsules containing KW-6002 or placebo (a look-alike pill with no active ingredient) once a day for 2 weeks, in addition to their regular Sinemet. All participants will receive placebo at least 2 weeks during the study; some patients will receive only placebo throughout the entire 7 weeks. At the end of weeks 1, 3 and 5, patients will be evaluated with a brief physical examination, routine blood and urine tests, and assessment of any adverse effects. Throughout the study, parkinsonian symptoms and dyskinesias will be evaluated and blood samples will be drawn periodically to measure drug levels.
NCT00006450
This study will examine the safety and effectiveness of treating brain tumors in children with a continuous infusion of phenylbutyrate. A breakdown product of this drug, phenylacetate, is normally found in low concentrations in the blood. At much higher concentrations, phenylbutyrate and phenylacetate are active against cancer in animals. Patients between 2 and 21 years old with a brain tumor that has progressed or recurred after radiation or chemotherapy, including bone marrow transplant, may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, magnetic resonance imaging (MRI) or computerized tomography (CT) of the head and, if needed, a spinal fluid test and bone marrow test. Study participants will have a continuous infusion of phenylbutyrate for two 28-day cycles-every day, 24 hours a day, 7 days a week. The medicine will be infused through a thin tube (catheter) placed in a large vein in the upper chest, delivered through a portable infusion pump. Patients will be hospitalized for at least 3 days when the treatment begins. If there are no side effects at that time, the infusions can continue on an outpatient basis. The patient or care giver will receive the medicine in 4-day supplies and will be taught how to change the bag and tubing daily for drug administration, as well as how to use the infusion pump. Patients will be monitored with weekly blood tests to look for side effects and measure blood levels of phenylbutyrate. They will have a physical examination at least once a week. At the end of the second 28-day cycle, patients will have a CT or MRI scan to evaluate the tumor's response to treatment. Patients whose tumor has grown will stop treatment and come off the study. Those whose tumor has remained stable or shrunk may continue phenylbutyrate as long as the treatment is beneficial and there are no serious side effects. CT or MRI scans will be done after every 2 cycles (or sooner if needed) to evaluate the treatment. Patients with certain tumor types (medulloblastoma, PNET, ependymoma, malignant germ cell tumor and pineoblastoma) or who have symptoms that indicate there might be tumor along the spinal cord may have a spinal tap. For this procedure, the patient lies on the side and a needle is inserted between two vertebrae (bones of the spine) in the lower back, into the cerebrospinal fluid space. A sample of fluid is drawn for testing for cancer cells. If the tumor has spread through the spinal fluid, a spinal tap will be done every other cycle (every 2 months) to monitor the effects of therapy.
NCT00001667
The purpose of this protocol is to identify families with inherited neurologic conditions, especially movement disorders, to evaluate affected and unaffected individuals clinically, and to obtain blood samples for genetic analysis.
NCT00004848
This protocol represents a continuation of a series of prospective studies to define the incidence and etiology of transfusion-associated hepatitis (TAH) and to examine the impact on TAH of various modifications in the selection of blood donors. The primary goal of the study will be to determine TAH incidence after the institution of a variety of interventive measures to exclude hepatitis and AIDS virus carriers: including surrogate assays (ALT, anti-HBc), a specific assay for the hepatitis C virus (HCV), a specific assay for the human immunodeficiency virus (HIV) and intensified donor questioning for high-risk behavior patterns. There is high probability that the exclusion of donors at high risk for AIDS transmission will also exclude donors at high risk for hepatitis transmission. Incidence data obtained in the study will be enhanced by the simultaneous follow-up of a control population undergoing identical surgical procedures, but receiving no blood or only autologous blood. This control population, made possible by the recent dramatic increase in the amount of autologous blood utilized, will allow for a clear distinction between transfusion-associated hepatitis and that due to nosocomial transmission or other background causes of hepatocellular inflammation in cardiac surgery patients.
NCT00005658
This study will test the safety and effectiveness of the amino acid glycine in treating psychotic disorders in children. The drug will be given as an adjunct (in addition) to the patient's current antipsychotic medication. Children age nine to 18 with schizophrenia or schizoaffective disorder whose symptoms began before age 13 may be eligible for this 10-week study. Patients will be hospitalized during the course of the trial. Weekend visits home may be permitted. Children enrolled in the study will be evaluated during a two-week pre-treatment period with written tests for IQ and academic functioning and with a magnetic resonance imaging (MRI) scan of the brain. For the MRI, the child lies on a table that slides into a large donut-shaped machine with a strong magnetic field. This procedure produces images of the brain that may help identify brain abnormalities in schizophrenia that develop in childhood. During the eight-week treatment phase, patients will receive glycine powder dissolved in water once a day, in addition to their other antipsychotic medications. They will undergo the following additional procedures during the course of treatment: 1. Comprehensive psychiatric examination 2. Blood pressure and pulse monitoring once a week 3. Blood tests every other week - About one ounce of blood is drawn per week to measure glycine levels 4. Eye movement study at week eight - Using a technique called infrared oculography, special detectors measure infrared light reflected off the child's eyes while he or she watches a moving square on a video monitor. 5. Lumbar puncture (spinal tap) once during the study - About one-half ounce of cerebrospinal fluid (the fluid surrounding the brain and spinal cord) is withdrawn through a needle placed in the lower part of the spine for analysis of brain chemicals. Patients who respond well may continue to receive glycine treatment through their referring physician after the study is completed. NIMH will follow patients by phone every six months and with visits at two-year intervals.
NCT00001659
Bereavement refers to the expected reactions and sadness associated with the loss of a loved one. It has been reported that the loss of a spouse is rated as the major life stressor among survivors of varying ages and diverse cultural backgrounds. Statistics have shown that in the United States over 800,000 men and women lose a spouse each year. A wide range of symptoms has been associated with bereavement including; depressed mood, tearfulness, sleep disturbances, and irrational behavior. Previous studies have shown that up to 50% of bereaved individuals can develop major depression. Bereavement has also been associated with dysfunction of the immune system. As a result, bereaved adults are more vulnerable to infection. However, the exact relationship between bereavement and immunity is uncertain. Researchers firmly believe that a relationship does exist between stress, more specifically bereavement, immunity, and the increased chance of dying following the loss of a long-term spouse. The objective of this study is to find possible links between bereavement, depression, and the immune system. This study will follow a group of elderly bereaved spouses and a group of elderly people who have not lost a long-term spouse. The group of bereaved individuals will be followed for approximately 13 months after the loss of their spouse and the group of controls will be followed for 13 months after entering the study. Researchers will make note of any clinical, biological, and immunological changes in any participants of the study.
NCT00001612
Patients enrolled in the original Early Treatment Diabetic Retinopathy Study at the Clinical Center at Johns Hopkins Wilmer Eye Institute will be invited for a follow-up visit at the National Eye Institute. Visual function will be assessed with manifest refraction and standardized visual acuity measurement. The progression of retinopathy will be evaluated by ocular exam and fundus photography. A brief medical history will be obtained. The goal of this study is to evaluate the long-term results of patients whose diabetic retinopathy was treated with different strategies of scatter and/or focal laser photocoagulation.
NCT00001253
The development of the brain in females is a result of a combination of factors. During puberty estrogen plays a role in influencing brain development. Cultural and environmental factors also play a role in the development of the brain. Female patients with Turner syndrome lack the ability to produce estrogen due to undeveloped ovaries. Therefore, Turner syndrome is the perfect condition to study how estrogen (or the lack of estrogen) influences a person's behavior and thinking. This study will compare cognitive differences (visual motor skills, visual-spatial, psychosocial behavior, and visual memory) of patients with Turner syndrome to normal patient controls. Researchers will use the Weschler Intelligence Scale for Children-Revised (WISC-R) along with other tests and scales to measure different aspects of the patient's cognitive ability. In addition the study will review patients with Turner syndrome who previously received estrogen replacement as infants and children in a related research study. Researchers hope to demonstrate that estrogen replacement will improve cognition and behavior in girls with Turner syndrome.
NCT00004576
This study will test the effectiveness of an experimental drug called LY300164 on improving Parkinson's disease symptoms, such as movement impairments and tremor, as well as involuntary movements produced by long-term treatment with levodopa. Patients with relatively advanced (Stage II to IV) Parkinson's disease between 30 and 75 years of age may be eligible for this 8-week study. Participants will have a complete medical history and physical examination, including blood tests and an electrocardiogram, and possibly brain magnetic resonance imaging (MRI), CT scan, and chest X-ray. Patients will stop taking all anti-parkinsonism medications except levodopa (Sinemet) and the experimental drug during the study. For the first 1 to 3 days, patients will be in the hospital for a levodopa "dose-finding" procedure. For this study, levodopa is infused through a vein for up to 8 hours, with symptoms monitored frequently to determine the doses that will produce two results: 1) the dose that is less than what is needed to relieve symptoms, and 2) the dose that relieves symptoms, but may produce dyskinesias. When these dose rates are determined, patients will begin treatment in one of two groups. One will take LY300164 3 times a day, along with levodopa, for 3 weeks. The second group will take placebo tablets (a look-alike tablet with no active ingredient) and levodopa on the same schedule as the LY300164 group. A brief medical examination and routine blood and urine tests will be done weekly. The drug dose will be increased every 3 to 4 days until significant side effects occur or the maximal dose is reached. Patients will be closely monitored for 4 hours after every increase. At the end of the 3 weeks, or when the maximal dose is reached, patients will be readmitted to the hospital for 2 to 3 days for a second levodopa dose-finding study, while continuing on LY300164 or placebo. After this test, patients will resume taking levodopa and the experimental drug or placebo as before for another 2 weeks. At the end of the 2-weeks, the entire procedure will be repeated in both groups, but the treatments will be switched-that is, the patients who were taking LY300164 will now take placebo, and the patients who took placebo will now take the drug. At the end of the second 3 weeks, the levodopa infusion procedure will be repeated once more. Throughout the study, parkinsonism symptoms and dyskinesias will be evaluated and blood samples will be drawn periodically to measure drug levels.
NCT00001496
Women who are at high risk for breast cancer, either because of linkage to high risk breast and ovarian cancer families, or because of a carcinoma in the opposite breast, will be studied. Women will have a physical examination and mammography to ensure that no breast abnormalities are present. Eligible women will undergo biopsy of the breast to obtain normal breast tissue. Short-term cell cultures will be established from this tissue and early passages of the short-term cell lines will be stored. A bank of high risk normal mammary epithelial cells will be established. To further characterize the mammary epithelial cells in this population of women, cell cultures will subsequently be analyzed for their growth and metabolic properties, sensitivity to chemopreventive agents, steroid receptor characteristics, oncogene expression and regulation, and genetic changes.
