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NCT00754221
This is a study to investigate the long-term safety and effectiveness \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.
NCT01083108
Background: * Bariatric surgery is the most effective way to achieve significant, long-term weight loss. It has also been shown to be an effective therapy for obese individuals with type 2 diabetes: more than 70 percent of patients no longer need medications for diabetes after surgery. This resolution of diabetes is predominately caused by marked weight loss resulting in improved insulin sensitivity. However, the beneficial effects of bariatric surgery on type 2 diabetes cannot be accounted for entirely by weight loss, because many bariatric surgery patients have resolution of diabetes within 1 week following bariatric surgery, even before they lose a clinically significant amount of weight. * One possible reason for the rapid resolution of diabetes after bariatric surgery .is that during the first week after surgery, patients can eat very little (about 300 Calories per day). It is well known that reducing calories to this level improves diabetes. Another possibility is that changes in the flow of food through the intestines may improve diabetes. Evidence for this comes from the observation that patients after gastric bypass have better glucose levels than those who have gastric banding. Researchers are interested in determining how much of the improvement in diabetes in the first week after Roux-en-Y gastric bypass (RYGBP) surgery is due to restricting calories, and how much is due to other factors, such as bypassing the upper part of the small intestine. Objectives: * To determine the change in total body insulin sensitivity after RYGBP compared to caloric restriction without surgery. * To study possible reasons for improvements in diabetes after RYGBP. Eligibility: \- Individuals 18 to 60 years of age who have a body mass index (BMI) greater than 35 and have type 2 diabetes. Design: \- This is not a randomized study, and patients will not receive bariatric surgery as part of this study. Two groups of patients will be studied: those scheduled for RYGBP surgery and those not undergoing surgery. * RYGBP Surgery Participants: * Up to 3 weeks before surgery, participants will spend 2 nights and days at the Vanderbilt University Clinical Research Center or the NIH Clinical Center for testing to learn about how their bodies handle sugar and use energy. During the 5 days prior to these tests, participants will be asked to not take diabetes medications, and will check blood sugar at least twice a day. * From 8 days before surgery, participants will begin an 800 Calorie per day liquid diet to prepare for surgery. * After surgery and discharge, participants will be readmitted to the Clinical Research Center at Vanderbilt or NIH for further tests and diet monitoring. Diabetes medications may be adjusted or stopped altogether based on the results of the tests. * Non-surgery Participants: * Participants will spend 2 nights and days in the NIH Clinical Center for testing to learn about how their bodies handle sugar and use energy. During the 5 days prior to these tests, participants will be asked to not take diabetes medications, and will check blood sugar at least twice a day. * After the tests, participants will begin an 800 Calorie per day liquid diet for 8 days. * After 8 days, participants will be readmitted to the Clinical Center at NIH for 1 week of further tests and a 300 Calorie per day diet. Diabetes medications may be adjusted or stopped altogether based on the results of the tests.
NCT00270478
This study will examine the use of hydroxyurea and erythropoietin for treating sickle cell disease in patients who also have kidney disease or pulmonary hypertension (high blood pressure in the lungs). Hydroxyurea increases production of fetal hemoglobin in the red blood cells of patients with sickle cell disease, reducing the amount of sickle cells that cause pain and other complications requiring hospitalizations. However, hydroxyurea treatment has limitations: patients with sickle cell disease who have developed kidney disease may not be able to get the full benefit of the medicine, and hydroxyurea alone may not be able to treat life-threatening complications such as pulmonary hypertension or stroke. This study will determine which of two dosing schedules of hydroxyurea and erythropoietin is more effective for treating patients with sickle cell disease who also have kidney disease or pulmonary hypertension, and will examine whether the two drugs can lower blood pressure in the lungs. Patients 18 years of age and older with sickle cell anemia and kidney disease or pulmonary hypertension, or both, may be eligible for this study. Candidates are screened with a medical history, physical examination, blood tests, a 6-minute walk test (test to see how far the subject can walk in 6 minutes), and echocardiogram (ultrasound of the heart to measure blood pressure in the lungs). Participants undergo the following tests and procedures: Stabilization Phase: Patients take 2 hydroxyurea tablets a day until their fetal hemoglobin levels stabilize, usually over 2 to 4 months. They have blood tests every 2 weeks to monitor hemoglobin and fetal hemoglobin levels. At some time during this period, they undergo a test to measure kidney function, in which they are injected with an iodine-containing dye and wear a small pump for 1 day that injects a small amount of dye under the skin over 24 hours. They come to the clinic for 2 or 3 blood tests collected over 4 hours. Sequence I (Standard): When the fetal hemoglobin levels have been stable for 2 months, patients have a repeat echocardiogram and 6-minute walk test. Erythropoietin is then added to the hydroxyurea regimen. It is given 3 days a week, as an injection under the skin, along with iron supplements. Patients have blood tests and blood pressure measurements every week or every other week. Patients with pulmonary hypertension have another echocardiogram and 6-minute walk test once the hemoglobin level is stable. Sequence II (Cycled): When hemoglobin levels have stabilized with hydroxyurea once a day and erythropoietin 3 times a week, the hydroxyurea is adjusted so that the amount taken in 7 days is "cycled" over 4 days, and the erythropoietin is cycled over 3 days, with the dose increased twice, every 3 to 4 weeks. Blood pressure and hemoglobin are monitored once or twice a month. Patients with pulmonary hypertension have another echocardiogram and 6-minute walk test once the hemoglobin level is stable. Patients who develop complications while taking the drugs have their treatment regimens adjusted as needed.
NCT00896272
This study aims to understand the impact of living with Klinefelter syndrome (KS) and the factors that contribute to adaptation in adolescents and adults. Individuals with KS may have variable symptoms, including hypogonadism, gynecomastia, learning disabilities, and delay and underdevelopment of secondary sexual characteristics. Perhaps the most challenging symptom of KS is infertility, which seems to be a universal symptom. It is not fully understood how males with KS conceptualize their condition, cope with their diagnosis, and adapt to living with this condition. In this study, Lazarus and Folkman s Transactional Model of Stress and Coping provides a framework for examining coping and adaptation in males with KS. A cross-sectional research design using a quantitative survey will be utilized to examine the relationships among appraisals (illness perceptions and perceived stigma), time elapsed since learning of diagnosis, coping, and adaptation. Adolescents and adults with KS will be recruited from national KS support networks via website postings, email listservs, and printed newsletter postings. Adolescents will also be recruited from a private practice. Participants will have the option to complete an online or paper version of the survey. The main outcome variable is adaptation to living with a KS diagnosis.
NCT00426465
This study will explore the optimum training schedule for stroke patients to learn motor skills. It will see if motor training is more effective when training sessions are distributed over time (spaced training) or when the sessions are scheduled close together (massed training). The results of this study may help researchers devise the best training schedule for patients to derive the maximum benefit from rehabilitation therapy. Healthy normal volunteers and people who have had a stroke may be eligible for this study. Patients must be 3 months post-stroke. All participants must be right-handed and between 18 and 80 years of age. Participants practice a pinch motor task and receive transcranial magnetic stimulation (TMS). Hand muscle activity is measured using surface electromyography (EMG). Pinch training involves training the participant to pinch as strongly as possible, using a device that records the force. For TMS, a wire coil is held on the subject s scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and taped to the skin over the muscle. Following one practice session of pinch task training and TMS, participants have four training sessions, which are scheduled 24 hours, 2 weeks, 1 month and 3 months after the practice session. For the 4- to 5-hour practice session, subjects do the following: * Perform a single session of pinch motor task for familiarization * Undergo TMS to measure brain activity * Practice five 6-minute blocks of pinch motor task with rest periods between sessions and perform a calculation task (addition and subtraction tasks) during each rest period * Receive TMS over 15 minutes. (Some sessions may have sham TMS.) * Read books and magazines during a 45-minute rest period * Perform a single block of the pinch motor task * Undergo TMS to measure brain activity * Complete a questionnaire that measures attention, fatigue and mood For the remaining four sessions, participants perform one practice block and TMS. Each session lasts about 2 hours.
NCT00255398
Kidney Disease Biomarkers Summary: This study will identify biomarkers (proteins and other molecules in the blood or urine) that may help scientists predict what kidney disease a patient has and whether a given patient would respond to particular therapies. The study will look for biomarkers in the blood and urine of patients with various kidney diseases and study of the effects of angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARB) on biomarkers. Blood and urine from healthy volunteers will be studied for comparison. Healthy people and the following patients may be eligible for this study: adults with diabetic nephropathy 18 years of age and older; children with newly diagnosed clinical idiopathic nephrotic syndrome between 2 and 18 year of age; children and adults with glomerular disease (minimal change disease, focal segmental glomerulosclerosis, or collapsing glomerulopathy). Participants undergo tests and procedures as follows: Glomerular Disease: Adults with glomerular disease provide about four to six blood and urine samples over the course of 6 to 12 months. The samples are collected at the time of regularly scheduled visits for the NIH treatment protocol in which they are participating. Children provide only blood samples. Chronic Kidney Disease: Patients with chronic kidney disease provide a blood and urine sample every 6 months for 3 years or more. Angiotensin Antagonism: Patients with chronic kidney disease who are taking ACE inhibitors or ARBs stop their medicines for 4 weeks, while those who are not taking ACE inhibitors or ARBs begin one of the medicines. In general, patients just starting on the medications continue them after the study is completed, since they are beneficial for chronic kidney disease. * Medication withdrawal group: Patients come to NIH for 2 successive days at the beginning of the study for blood and urine tests (including one 24-hour urine collection) and to receive iothalamate (a chemical used to measure kidney function). Iothalamate is delivered over 24 hours through a needle placed in the abdomen (or elsewhere) via a pump similar to pumps that some diabetics use to deliver insulin. Patients then stop taking their ACE inhibitor or ARB medication. They monitor their blood pressure every day and return to NIH after 1, 2 and 4 weeks for blood tests. During week 4, the iothalamate infusion is repeated, and blood and urine samples are collected as at the beginning of the study. Patients then resume taking their ACE inhibitor or ARB once a day with the dose being increased at 2-week intervals. They come to NIH weekly after 1 week and then every other week for blood tests. Four weeks after reaching the highest FDA-recommended dose of medication tolerated, the iothalamate infusion and blood and urine collections are repeated. * Medication induction group: At the beginning of the study, patients have the iothalamate infusion and blood and urine collections described above and then begin to take either an ACE inhibitor or ARB. The dose is increased after 2 weeks. Patients monitor their blood pressure every day. After being on the highest dose for 4 weeks, patients repeat the iothalamate infusion and blood and urine collections. The study is then complete and they are provided a 2-month supply of medicine to take home. Information is gathered on symptoms, treatments, and results of past laboratory tests of all patients. Healthy volunteers provide blood and urine sample collections every month or every other month for up to four collections to be used for biomarker studies and the screen for common chronic diseases.
NCT01702935
Background: \- Primary ovarian insufficiency (POI) is a condition that affects ovary function. It means that the ovaries are not able to function at a level appropriate for a woman's age. Previously, it was thought that women had only a fixed number of eggs that were lost each month until none were left at menopause. However, recently, stem cells have been found in the ovaries of adult women. These stem cells may be able to make new eggs. Studying these cells may help women with POI in the future. Researchers want to collect ovarian tissue from women with POI to investigate ovarian stem cells. Objectives: \- To collect ovarian tissue from women with primary ovarian insufficiency. Eligibility: \- Women between 18 and 50 years of age with primary ovarian insufficiency. Design: * Participants will be screened with a physical exam and medical history. They will also have a full gynecological exam. They will provide blood and urine samples. * Participants will donate ovarian tissue for study. It will be collected through outpatient surgery. The surgery will take either half of an ovary or a full ovary. * Treatment will not be provided as part of this study.
NCT01122914
Background: * Severe atopic dermatitis, also known as eczema, is a chronic inflammatory skin condition that affects both children and adults and causes severe itching and skin redness. Current treatments of atopic dermatitis include topical creams and lotions, light therapy, and medications. However, the difficulty with long-term treatment for the chronic and severe nature of the disease requires more effective and better-tolerated therapeutic options. * Anakinra is a drug that blocks a substance called interleukin-1 (IL-1), which may be important in causing the inflammation in atopic dermatitis. Researchers are interested in determining whether anakinra can be used to help treat atopic dermatitis. Anakinra has been approved by the Food and Drug Administration to treat rheumatoid arthritis in adults and children, but it has not been approved for use in adults or children with atopic dermatitis and is considered an experimental treatment in this study. In this study Anakinra will be administered as an injection under the skin every day for 3 months Objectives: \- To assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis in children. Eligibility: \- Children between 10 and 18 years of age who have been diagnosed with severe atopic dermatitis that has not responded to standard treatment. Design: * Initial Screening: Participants will have an initial screening visit with a complete physical examination and medical history, blood and urine tests, photographs of the skin ,skin biopsy, and other tests as required. * Run-in Period: At the screening visit, participants will receive a diary card and will be asked to track their atopic dermatitis symptoms on standard treatment for 2 months. * Start of Treatment: At the end of the 2 month Run-in period participants will return for an inpatient visit (2 days) to receive the initial dose of anakinra and will be watched for any side effects. During the inpatient visit, participants will have additional examinations and blood and urine tests, and will be instructed on how to administer the anakinra injections at home. Treatment Period: - Participants will return once a week for the first 2 weeks of treatment, at the end of the first month, and then once a month for the following 2 months, for a physical exam and blood tests. Participants will be asked to record symptoms related to their atopic dermatitis, anakinra administration and any side effects related to the anakinra on the diary card. The diary cards will be reviewed and collected at each visit.- End of Treatment Period: At the end of 3 months of treatment with anakinra, participants will again be asked to record symptoms related to their atopic dermatitis on the diary card. Participants will be seen once a month for 3 months for a physical exam, blood tests and review of the diary card. . The final study visit will take place at the end of the 3rd month and will include a physical exam, blood tests, photographs and skin biopsy.
NCT02206464
Background:\<TAB\> \- Flu virus that causes disease in birds can sometimes spread to people. It can cause severe illness, even death. Vaccines are used to try to create resistance to such infections. Researchers want to test a new vaccination strategy, combining two different vaccine types, the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one of two combinations offer better protection against a certain type of bird flu in humans when compared to vaccination using two doses of MIV alone. Objectives: * To see if 2 vaccines for bird flu, are safe and tolerable for humans. * To study immune responses to these vaccines. Eligibility: \- Healthy adults 18 60 years old. Design: * Participants will be screened through a separate protocol. * Participants will be randomly assigned to 1 of 3 groups. Each group will get a different combination of vaccines. * Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be drawn at some visits. Urine samples may be collected. * Participants will receive vaccinations at 2 of the visits, 16 weeks apart. * The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA vaccine will be injected in the upper arm using a device that delivers the vaccine through the skin by pressure instead of a needle. * Participants will be observed for at least 30 minutes after each vaccination. * Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for evaluation, and complete a diary at home for 1 week. They will record their temperature and symptoms and look at the injection site daily. * Participants will have follow-up blood tests.
NCT00001852
This study will follow patients with salivary gland dysfunction to identify the long-term course of this disorder and its effects on the mouth, oral function, and overall health. Saliva is important in maintaining oral health and comfort. It moistens the mouth, lubricates food for easier swallowing, provides enzymes needed to begin the digestive process and promotes repair and cleansing of soft tissues of the mouth. Decreased salivary production or changes in salivary composition may affect oral and systemic health and cause an increase in tooth decay. Patients 4 years of age and older with dry mouth symptoms and a diagnosis of primary, secondary or incomplete Sj(SqrRoot)(Delta)gren s syndrome or salivary gland dysfunction due to radiation may be eligible for this study. Candidates will be screened with a complete medical and dental history and blood and saliva tests. Some patients will have a biopsy of the minor salivary glands, usually from the lower lip, to confirm or rule out the diagnosis of Sj(SqrRoot)(Delta)gren s syndrome and determine the extent of changes in the salivary glands. (A biopsy is the surgical removal of a small piece of tissue for laboratory examination.) The ability to taste and smell may also be evaluated, and patients may have an ultrasound examination of their swallowing function. Participants will have a general oral examination of the teeth and soft tissues of the mouth, general physical examination, eye examination and blood tests and will fill out a questionnaire on oral health and function. In addition, they will have the following tests and procedures: * Identification of possible fungal infection Patients rinse their mouth with 2 teaspoons of a salt-water solution and spit it in a sterile container for laboratory examination. If a fungal infection is detected, treatment will be offered. * Unstimulated salivary function assessment Saliva production is measured by collecting saliva samples through small suction cups connected to collection tubes over the salivary gland ducts in the mouth. * Stimulated salivary function assessment A sour-tasting liquid (2% citric acid) is applied to the top and sides of the tongue at 30-second intervals to stimulation saliva production while saliva is collected using the procedure described above. * Identification of markers of precancerous lesions The salivary gland biopsy done at the screening evaluation (or from outside sources) is examined for markers of precancerous lesions, as about 5 percent of patients with Sj(SqrRoot)(Delta)gren's syndrome develop a tumor called Non-Hodgkin s lymphoma. In some cases, the minor salivary glands may be re-biopsied a few years after the screening biopsy. Patients will be followed once a year with a comprehensive history and physical examination, eye examination, full oral examination, salivary function assessment and questionnaires about signs and symptoms of salivary gland dysfunction.
NCT01059201
Background: * Research into the genetic causes of autism spectrum disorder (ASD) involves studies of the DNA of children with autism. New DNA sequencing technology allows researchers to study specific genes in search of genetic changes that may cause or contribute to ASD. Individuals who donated DNA to the Autism Genetic Resource Exchange may benefit from further study of their DNA samples with more advanced DNA sequencing technology. * The role of cholesterol in individuals with ASD is currently under investigation. Research has suggested that abnormal cholesterol levels in children with autism may be related to genetic mutations or changes in how cholesterol is regulated in the body. Objectives: \- To study existing blood samples of children with autism spectrum disorders to evaluate the relationship between genetic traits and cholesterol function. Eligibility: \- Children with ASD who donated blood samples to the Autism Genetic Resource Exchange. Design: * Parents/guardians of minor children with ASD will provide consent for further research to be performed on existing DNA samples in the Autism Genetic Research Exchange databank. Information from this research may be provided to the consenting parents/guardians on a case by case basis, as directed by the researchers.
NCT00316069
This study is designed for the collection of stem cells from the bloodstream for use in research studies. These cells will be studied to determine if they have unique features particular to the donor that may or may not affect their use for developing new treatments. Volunteers with or without a blood disease may be eligible to donate stem cells for this study. Women who are pregnant or breastfeeding may not enroll. Donors are evaluated with a medical history and physical examination, blood tests and an ultrasound examination of the spleen. They then undergo stem cell mobilization and apheresis as follows: Donors are given injections of a hormone called G-CSF every day for 5 days to stimulate release of stem cells from the bone marrow into the bloodstream for collection. On the day of the last injection, donors undergo apheresis to obtain white cells and stem cells. For this procedure, blood is withdrawn through a catheter (plastic tube) placed in a vein and directed into a machine where the white cells and stem cells are separated from the rest of the blood by a spinning process. These cells are extracted and collected in a bag inside the machine, and the rest of the blood is returned to the donor through a second catheter in a vein in the other arm. The procedure takes 4 to 5 hours.
NCT01092208
Background: * Researchers who are studying autism spectrum disorders are interested in developing a collection of research samples from both children with autism and healthy individuals, some of whom may be related to the children with autism. * The genetic condition tuberous sclerosis, which can cause the growth of benign tumors in the brain and other parts of the body, is also linked with autism. Researchers have been able to determine the specific genetic mutations involved in tuberous sclerosis, and as a result are interested in studying the genetic information of children who have both tuberous sclerosis and autism, as well as tuberous sclerosis without autism. Objectives: \- To develop a collection of DNA samples from blood and skin samples taken from children with autism and/or tuberous sclerosis, as well as healthy volunteers. Eligibility: * Children between 4 to 18 years of age who have autism and/or tuberous sclerosis, or are healthy volunteers. * Some of the healthy volunteers will be siblings of children with autism. Design: * Participants will be screened with a medical history and a physical examination, and may also have a genetic evaluation. * Participants will provide a blood sample and a skin biopsy for further study. * No treatment will be provided as part of this protocol.
NCT00001606
This studied is designed to discover the genes that cause hearing impairment. More precisely, this study aims to map and clone genes that are important for the development and maintenance of the anatomy and physiology related to hearing (auditory system). The study will begin by finding large families who have members with hearing impairment. Once families are found, members with and without hearing impairment will be evaluated by an audiologist and a clinician (doctor). An audiologist, is a person trained in evaluating, habilitating, and rehabilitating people with disorders of hearing function. The clinician's responsibility is to examine the patients and check for other signs and symptoms related to hearing. Finding the gene for hearing impairment requires: 1. \<TAB\>DNA samples of hearing impaired family members, taken from standard blood samples. 2. \<TAB\>DNA samples of members of the family without hearing impairment, taken from standard blood samples. 3. \<TAB\>Results of hearing tests conducted by the audiologist for all participants. Once all members of the family are evaluated researchers can create a pedigree. A pedigree is like a family tree that charts members of a family with a genetic disorder, like hearing impairment. Pedigrees are used to determine the mode of inheritance of the gene responsible for a particular condition. Finally, researcher intend on using all the information gathered as well as methods for genetic analysis to map out the location of the gene. Patients participating in this study will not directly benefit from its research, but scientific understanding achieved may help researchers better understand the auditory system and someday prevent deafness.\<TAB\>...
NCT00544102
This study will test the effects of insulin resistance on atherosclerosis (hardening of the arteries) in women who have systemic lupus erythematosus, more commonly known as lupus. Women with lupus have a higher chance of developing atherosclerosis than the general population, and as a result are more susceptible to heart attack and stroke. Insulin resistance is a particular risk factor for atherosclerosis, and recent small studies have shown that insulin resistance is more common in lupus patients than in those without lupus. The study will consist of a series of tests designed to assess whether there is an association between insulin resistance and atherosclerosis in women with lupus. This research may lead to further studies on possible treatments to reduce the risk of heart disease in lupus patients. Volunteers must be women between 30 and 55 years of age who were diagnosed with lupus within five or more years prior to the study. Volunteers who have kidney failure, diabetes, or existing atherosclerosis will be excluded from the study, as will volunteers who have had pulse steroid therapy within four weeks of the testing or who have been pregnant within one year of the testing. Participants will undergo the following procedures on an outpatient basis: * Blood and urine tests for research purposes. * Electrocardiogram (EKG) to test the general health of the heart. * Oral glucose tolerance test to measure blood glucose and insulin levels. This test is commonly used to diagnose diabetes and pre-diabetic insulin resistance. * Cardiac multidetector computed tomography (MDCT) to determine the amount of calcium present in coronary arteries. This test is used to diagnose atherosclerosis. * Carotid artery ultrasound to show the speed of blood flow through the carotid arteries. This test will show abnormalities and/or blockages in the carotid arteries. * Abdominal ultrasound to determine if the participant has hepatic steatosis ( fatty liver ), which is often found in individuals with insulin resistance and diabetes. * Carotid artery magnetic resonance imaging/angiogram (MRI/MRA) to measure the thickness of blood vessels. This test is used to diagnose atherosclerosis. * Abdominal MRI to estimate abdominal fat. Volunteers may be asked to participate in an MRI/MRA study to evaluate the arteries of the heart. This test is optional and not required by the insulin resistance/atherosclerosis study. The entire series of procedures will require one to three visits to complete.
NCT00533416
This study will determine the highest dose of the experimental drug ON 01910.Na that can safely be given to patients with the bone marrow disorder myelodysplasia (MDS) and patients with refractory AML with trisomy 8. In this disease, the bone marrow can make some blood cells, but very few of these cells are released into the blood for use in the body. ON 01910.Na is an experimental drug that inhibits a protein called cyclinD1that is important for keeping MDS cells alive. In laboratory experiments, ON 01910.Na has acted against cyclinD1, causing MDS cells to die. The study will also evaluate how the body handles ON 01910.Na, the effect of the drug on MDS and AML and its side effects. Patients 18 to 85 years old with MDS or AML who do not have a suitable sibling donor for a marrow transplant or who are not willing to have a transplant may be eligible for this study. Participants receive ON 01910.Na in 2-week treatment cycles, with 3 to 5 days of drug infusion through a vein followed by 9 to 11 days of observation. To find the highest safe dose of ON 01910.Na, the first person enrolled in the study is given the smallest study dose of the drug for 3 days, followed 2 weeks later with a second dose for 3 days. If these doses are found safe, the next two people receive the same dose. If these subjects do well, the next group of patients receives the next higher dose level. The dose continues to be increased in groups of 3 to 6 subjects until the fourth and highest dose level is reached. Patients who do well on the treatment may receive an additional six cycles of ON 01910.Na (3 to 5 days of infusion once every other week for 12 weeks). Before, during and after the treatment period, patients are periodically evaluated and monitored with the following tests and procedures: * Physical examination and review of medical and medication history. * Blood and urine tests. * Pregnancy test for women of childbearing age. * Electrocardiogram (EKG) and chest X-ray. * Bone marrow biopsy.
NCT00341705
The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions. Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another. Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections. Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.
NCT00295308
Background: * Though the drug buprenorphine effectively treats dependence on opioids like heroin, some abstinent patients relapse to use during treatment. This relapse may be triggered by stress or stressful situations, and buprenorphine probably has no specific protective effect in these situations. Buprenorphine probably also has no specific effect on relapse to cocaine use. * Research has shown that clonidine, a drug originally prescribed to treat high blood pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse to heroin and cocaine seeking in rats. Researchers are interested in studying whether a combination of clonidine and buprenorphine may be more effective in preventing drug relapse than administering one of the medications alone. Objectives: \- To determine whether clonidine, given to abstinent patients maintained on buprenorphine, is more effective than placebo in preventing relapse to heroin or cocaine use. Eligibility: \- Individuals between 18 and 50 years of age who are current cocaine or heroin users seeking treatment. Design: * The study will last up to 36 weeks, with four phases of treatment and a follow-up evaluation. Three times a week, participants will be asked to report illicit drug use and provide urine and breath samples. Throughout the study, participants will receive individual counseling in weekly 40 60 minute sessions. Other samples and tests will be scheduled as required by the study researchers. * Patients will be stabilized on daily buprenorphine over the first 14 days of the study. * Weeks 1 8: Participants will receive vouchers for regular substance-free urine samples. Those who successfully complete this phase will continue to the next part of the study. * Weeks 7 9: Participants will receive either clonidine or placebo along with the buprenorphine. The dose of clonidine will be stabilized during this time. * Weeks 9 22: Participants will continue to receive either clonidine or placebo along with the buprenorphine. During this part of the study, participants will keep electronic diaries to record drug use or craving and to record data on mood, stress levels, and activity. * Weeks 23 28: Participants will stop taking the clonidine or placebo, but will continue the buprenorphine treatment. Participants will continue to keep electronic diaries. * Weeks 29 36: Participants will have the choice of transferring to a community clinic transfer or gradually reducing doses of buprenorphine to end the study. * Participants will return for a follow-up visit and urine sample 6 months after the end of the study.
NCT01036074
Background: \- Cocaine affects the brain's ability to process information. However, different people respond to cocaine in different ways, and differences in brain structure and function may affect how cocaine alters brain activity. By using functional magnetic resonance imaging (fMRI) to monitor brain activity during tasks that provide simple rewards, researchers hope to better understand how the brain responds to rewards and how this response is affected by drugs like cocaine. Objectives: * To determine the effect of cocaine administration on the reward experience in cocaine-dependent individuals. * To study genetic and personality factors that may contribute to cocaine dependence. Eligibility: \- Individuals between 18 and 45 years of age who either are cocaine-dependent and not seeking treatment or are healthy volunteers. Design: * Participants will be asked to avoid consuming alcohol and restrict consumption of caffeine prior to the study. Participants provide urine and breath samples to be tested for chemicals that may interfere with the study. * All participants will complete a training session and at least one fMRI scanning session. During the training session, participants will be introduced to the reward tasks and MRI equipment. * Healthy volunteers will have a single fMRI session that will involve reward tasks to be completed during the scanning. Rewards will include small amounts of fruit juice and the opportunity to win money. * Cocaine-dependent participants will have a training session and three experimental sessions including 1) a mock MRI scan to test cocaine tolerance, 2) one fMRI scan with reward tasks after administration of IV cocaine, and 3) one fMRI scan with reward tasks after administration of IV placebo (saline solution). Rewards will include small amounts of fruit juice and the opportunity to win money. * In addition to the scans, participants will provide a blood sample for further study and will answer questionnaires provided by the researchers.
NCT01431677
Background: \- In individuals as they age, changes in muscle tissue can significantly affect their muscle strength and exercise endurance. This process, known as sarcopenia, may lead to decreased mobility and physical weakness, which is what we in general refer to as frailty. The causes of sarcopenia and why it affects some individuals more than others are not known, but many factors influence muscle physiology and function, including metabolic, hormonal, environmental, and lifestyle factors. Researchers interested in identifying factors involved in the start and progression of sarcopenia need of samples of human muscle tissue and cells for laboratory investigations. Objectives: * To train researchers in the appropriate procedures for performing muscle biopsies and collecting, labeling, and storing the samples. * Develop a data base of specific scientific studies evaluating the physiological and metabolic function of muscle that can be used in future studies. Eligibility: \- Healthy volunteers at least 18 years of age. Design: * Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, and will schedule a date for the muscle biopsy. * Participants will have a muscle biopsy, with tissue and cells taken from the upper part of the thigh. A local anesthetic will be given for the procedure. Participants will also provide a blood sample and have an electrocardiogram to evaluate heart function. * Participants will have a followup visit 1 week after the biopsy visit to evaluate the healing process and provide any further treatment for the affected area, after which they may fully resume normal activities.
