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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.
NCT01168284
In recent years, there have been a growing number of individuals diagnosed with Autism Spectrum Disorders (ASD). As such, this increase has expanded the number of caregivers of children with ASD. Research has shown that having a child with an ASD is stressful for caregivers and their families. More specifically, prior research suggests that caregivers of children with ASD may find it difficult to maintain feelings of control and to cope with the overall physical and emotional demands of caring for their child. A previous study of caregivers of children with ASD found that caregivers felt a lack of personal control over aspects of their child s condition and also found it difficult to cope with various demands of caregiving. Furthermore, this study found that greater levels of perceived personal control and the use of problem-focused coping strategies were associated with caregivers adaptation to their child s condition. As such, the goal of our research is to conduct a feasibility study using a coping effectiveness training (CET) intervention designed to enhance perceived personal control (PPC) and coping efficacy in caregivers of children with ASD. There has been a growing interest in developing interventions targeted at constructs involved in the adaptation process. However, there have been few studies of interventions targeting predictors of adaptation such as PPC and coping efficacy. Research has shown that the CET intervention can enhance coping efficacy in several other populations. This intervention also incorporates appraisals of one s ability to change a particular situation. The conceptual framework for our study was adapted from Lazarus and Folkman s Transactional Model of Stress and Coping. A cross-sectional randomized treatment-control design is proposed to evaluate the use of a CET intervention intended to enhance PPC and coping efficacy. Caregivers of children with ASD will be recruited from support groups, autism resource centers, and four clinics. Participants randomized to the treatment group will be asked to complete baseline and follow-up surveys and two 1.5-hour individualized in-person sessions. Participants randomized to the control group will be asked to complete baseline and follow-up surveys and two 1.5-hour individualized in-person client-centered discussion sessions. The main outcome measures will be participation, reasons for withdrawal, participants experiences within the intervention setting and their experiences in applying the intervention, PPC, coping efficacy, and coping effectiveness.
NCT00235495
The goal of the trial is to determine whether human albumin, administered within 5 hours of symptom onset, improves the 3-month outcome of subjects with acute ischemic stroke.
NCT03065907
The purpose of this research is to collect preliminary data in preparation for conducting a randomized clinical trial to determine the relative effectiveness of vision rehabilitation in improving overall visual ability (primary aim) and reducing depression (secondary aim) in patients receiving anti-VEGF therapy for neovascular age-related macular degeneration integrated over time.
NCT01136642
Background: * Smoking is the leading cause of preventable death in the United States, and researchers are interested in gaining a better understanding of the perceived beneficial effects of nicotine to help improve treatment strategies for nicotine dependence. Understanding the conditions under which nicotine improves attention and cognitive processing may provide more useful information for this research. * The ability to pay attention and filter relevant from irrelevant stimuli is central to all aspects of information-processing. Top-down and bottom-up attentional processes illustrate how the brain combines stimuli and goal-directed behaviors. Bottom-up processing is an unconscious response to sensory input; for instance, when the eyes automatically focus on a prominent image in a picture. Top-down processing is a conscious response to drive attention toward specific stimuli; for instance, when a person is asked to focus on a less immediately noticeable image in a picture. Researchers are interested in determining whether nicotine improves cognitive performance by acting on top-down or bottom-up attentional mechanisms. Objectives: \- To investigate the effect of nicotine on the top-down and bottom-up mechanisms of attention in cigarette smokers. Eligibility: \- Current smokers (at least 10 cigarettes per day for at least 1 year) between 18 and 55 years of age. Design: * This study will involve one training session and four experimental sessions. * During the training session, participants will receive a sample dose of the nicotine nasal spray used in the study to determine if they can tolerate the effects. * For each experimental session, participants will receive one dose of nicotine nasal spray (1 mg, 2 mg, or 3 mg) or placebo spray, followed by blood pressure and heart rate monitoring, performance of an attentional test, and questionnaires to rate participants perception of nicotine effectiveness. Participants may receive different doses at different sessions, and will not be told which dose they will receive at any given point.
NCT00368043
The deleterious effects of institutionalized care on the health and growth and development of children have been described. Early studies have shown that the effects of institutionalized care on a child's growth and development may not be fully reversible. The exact mechanism through which these early stresses affect bio-behavioral outcomes has yet to be determined. A likely mechanism in which environmental influences could regulate both biological and psychosocial development may be through the hypothalamic pituitary adrenal axis (HPA). Recent advances in the area of brain research have enriched our understanding of the importance of early life experiences on physical, cognitive, developmental, mental and behavioral health outcomes. Children adopted from orphanages in countries as diverse as the former Soviet Union and Guatemala provide an opportunity to learn more about the effect of deprivation on neuro-endocrine function, physical growth, and developmental outcomes, including cognitive, and behavioral measures. This protocol proposes to study the changes of the HPA axis of the post-institutionalized adoptive child, ages 10 months to 4 years, which may help elucidate the etiology of the complex findings in this population. We will recruit 60 adopted children who experienced institutionalized care and were recently adopted by a US family and 60 controls. Our primary hypothesis is that a number of adopted children will have biochemical evidence of stress-induced activation of the HPA axis and sympathetic adrenal medullary system. HPA dysfunction will be evident by abnormal diurnal salivary cortisol levels, increased cortisol and/or catecholamine excretion in 24 hours urine measurements, and dysregulation of autonomic nervous system activity We also hypothesize that many of these responses will not normalize with time and that there will be a correlation between these responses and growth and behavioral disorders. In addition, we will examine nutritional intake and sleep patterns to determine their effect on growth and developmental outcome.
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.
NCT00422071
This study will use transcranial magnetic stimulation (TMS) to determine whether the activity in the brain when someone wins something affects the part of the brain that controls movement. Studies have shown that the brain releases signals to mark rewards for certain behavior, like the activity the brain generates when an animal receives food or drink after performing a certain action. This study will look for a way to detect this kind of signal in humans. Healthy volunteers between 18 and 60 years of age are eligible for this study. Participants undergo TMS during two experiments slot machine stimulation and key sequence (see below). 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 stimulation may cause twitching in muscles of the face, arm or leg, and there may be a pulling sensation on the skin under the coil. The effect of TMS on the muscles is detected with small metal disk electrodes taped onto the skin of the arms or legs. The stimulation strength needed to activate the hand muscles is determined at the beginning of each experiment. To do this, the subject sits with his or her arms and hand relaxed. Magnetic pulses of varying strengths are applied in order to find the right strength. Also, a series of 45 pairs of magnetic pulses is administered so close to each other that they produce only one movement. Measurements of the movements generated serve as a baseline for comparison with movements generated during the experiments. Slot Machine Simulation Subjects play a computer game similar to a slot machine. They press a button to start the game and watch as three barrels of the machine spin into place. Subjects can win $0.25, $1or $5 if all three barrels match when they stop spinning. If all three barrels do not match, subjects do not win any money, except in rare instances, when they are awarded money even when all three barrels do not match. In one trial in this experiment, subjects receive transcranial magnetic stimulation after they see the second barrel stop spinning. In another trial, they receive the stimulation after the third barrel stops spinning. Key Sequence Subjects see a letter on a computer screen and press a combination of the three keyboard keys G, H, and J. If they press the keys in the right order and under the time limit, they win $1. At some point, the letter displayed changes, and the subjects must guess a new combination to earn money. Each of the letters corresponds to its own combination of key presses. A few moments after the subjects see whether they pressed the keys in the right order, they receive TMS.
NCT00082043
This study will explore the effects of dutasteride on mood and the stress response across the menstrual cycle. Dutasteride blocks production of neurosteroids-hormones that help regulate the stress response systems. These systems may be disturbed in women with menstrually related mood disorders (MRMD). The effects of the drug will be compared in women with and without MRMD to determine how neurosteroids regulate mood and the stress response across the menstrual cycle. Dutasteride is approved by the Food and Drug Administration to treat benign prostatic hyperplasia (excess growth of the prostate gland) in men. Menstruating women 30 to 45 years of age with and without MRMD may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, screening for symptoms of depression, and routine blood and urine tests. Participants are required to use barrier contraception (condoms or diaphragm) during the 3-month study and 6-month follow-up. Participants undergo the following tests and procedures: * Dutasteride or placebo treatment: Participants receive 1 month of dutasteride and 2 months of placebo. Neither the participants nor the investigators know when the subject is taking the active medication or the placebo. * Biweekly follow-up visits: Every 2 weeks during the 3-month treatment period, patients come to the NIH Clinical Center to have blood drawn and to complete mood symptoms ratings. * Monthly follow-up visits: Participants return to the Clinical Center once a month for 6 months after the end of the treatment period to monitor hormone levels and pregnancy status.
NCT00026767
This study will collect data on the incidence (rate of occurrence) of fungal infections in recipients of bone marrow, stem cell or organ transplants. The data will provide information needed to develop strategies for prevention and early treatment of fungal infections in these patients. Any patient receiving bone marrow transplantation, peripheral stem cell transplantation or solid organ transplantation is eligible for this study. The survey will be conducted over a 3-year period at about 20 collaborating transplant centers. Through the annual accrual of more than 9,000 patients, it is estimated that at least 5 to 8 percent per year will have documented or suspected invasive fungal infections. The study will be conducted in three phases as follows: * Phase 1 A 6-month "start-up" phase during which sites will initiate screening and begin collecting data on incident cases of invasive fungal infections. * Phase 2 A 2-year phase in which all sites will conduct surveillance and collect data and specimens in a standardized fashion. * Phase 3 A 6-month "wrap-up" phase during which active surveillance for invasive fungal infections will be conducted only among patients who were transplanted before the beginning of this phase. Patient care will be provided through the patient s primary protocol and standard of care. ...
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.
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.
NCT01989533
Background: \- Vaccines create resistance to disease. This study tests experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus as a transporter. Transporters may help vaccines stimulate an immune response against HIV. This means the body works to fight infection. Researchers want to see if different ways of giving the vaccines cause different immune responses. They also want to see if the vaccines adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections. Participants cannot get HIV from these vaccines. But they can get the adenovirus, so their entire household and intimate contacts must participate. Objective: \- To test the safety of experimental HIV vaccines. Eligibility: \- Healthy adults 18-49 years old. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. * Participants will receive the vaccine 3 times over 6 months. Each time, they will have a physical exam and blood and urine tests. Samples will be taken from their nose, rectum, and cervix. * Some participants will receive the vaccine by swallowing 11 capsules with water. Clinic staff will observe them for 1 hour. * Some participants will receive the vaccine swabbed in their throat. They will get dose 1 at the hospital and stay there for 1 week. They will have medical tests and nose swabs. Doses 2 and 3 will not require a hospital stay. * Participants will have 7 follow-up visits over 6 months, with a physical exam and blood tests. Samples will be taken from their nose, throat, and rectum. * Household and intimate contacts will have 4 clinic visits over 8 months, with a physical exam and blood tests.
NCT02089776
Background: \- People can learn to use feedback about brain activity to change that activity. Researchers want to see if people who have had a stroke can change their brain activity by practice and thought with feedback, and if that improves motor control. They will study brain activity in people who have and have not had strokes. Objectives: \- To see if people with stroke can change their brain activity and improve motor control by practice and thought. Eligibility: * Adults 18 80 years old who have had a stroke. * Healthy volunteers 18 80 years old. Design: * Participants will be screened with a medical history, MRI, and physical exam. For MRI, a magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides in and out of a cylinder. They will be in the scanner less than 2 hours, lying still for up to 15 minutes at a time. The scanner makes loud noises. Participants will get earplugs. * Participants will have up to 3 scanning visits and up to 3 follow-up visits within 24 weeks. Visits may include screening, MRI, functional MRI (fMRI), questionnaires, and simple motor tests. Stroke participants may take additional motor tests, including transcranial magnetic stimulation (TMS). * fMRI: During this MRI, small metal disks may be taped to the skin or a fabric glove with small wires in it may be used to monitor hand movements. Heart rate and breathing may also be monitored. Participants may be monitored by video and asked to perform tasks. * TMS: A brief electrical current goes through a coil on the scalp. It creates a magnetic pulse that stimulates the brain. Participants may be asked to perform simple actions. Finger or hand movements may be recorded.
NCT01629082
Background: * Several types of blood cancer are associated with poor outcomes including high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myelogenous leukemia (AML). Many people with MDS, CMML, and AML are not candidates for standard treatments. New types of treatment are needed for these cancers. * Clofarabine and lenalidomide are anticancer drugs. The first damages cancer cells in the body. The second can alter blood supply to abnormal cells or affect how the immune system attacks these cells. These drugs have been previously tested as treatments for MDS and leukemia. However, they have not been tried as a combination for MDS, CMML, and AML. Researchers want to see if these drugs are safe and effective for these types of cancer. Objectives: \- To test the safety and effectiveness of clofarabine and lenalidomide for people with high-risk MDS, CMML, and AML. Eligibility: * Individuals at least 18 years of age who have high-risk MDS, CMML, and AML. * Participants must not be candidates for standard treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and bone marrow samples will be collected. * Participants will have 5 days of treatment with clofarabine. It will be given through a vein during an inpatient hospital stay. If there are no serious side effects after the infusion, participants will continue treatment as outpatients. * After 28 days, participants will have a bone marrow biopsy to check their response to treatment. * After the biopsy, participants will start lenalidomide treatment. Half of the participants will take the drug for 28 days (one treatment cycle). The other half will take it for 56 days (two cycles). More blood tests and biopsies will be used to monitor treatment. * If there are no serious side effects and the disease does not become worse, participants may keep taking lenalidomide at lower doses for up to 12 more cycles.
NCT00001921
This study will explore how the brain works during memory testing in an effort to understand why some patients with schizophrenia have memory difficulties. Patients with schizophrenia and their unaffected family members are eligible for this study. Studying family members may help identify the genes related to the memory deficit in schizophrenia. Normal volunteers will also be studied. Normal volunteers, patients with schizophrenia, and their family members interested in participating in this study will be screened with a complete medical examination and psychiatric assessment, and performance of simple tasks. Study participants will be shown numbers on a screen and asked to recall them after a brief period. This will be done during electroencephalographic (EEG) recording, in which electrodes attached to the scalp measure the brain s electrical activity. The same test will be repeated while the patient has magnetic resonance imaging of the brain. The combined MRI and EEG testing will permit better localization of the brain s electrical activity. ...
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.
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.
NCT00361777
This study will test the accuracy of screening tests for Cushing s syndrome in overweight people with signs of the disorder. Cushing s syndrome is a rare disorder caused by excess production of the hormone cortisol. Patients may have various problems, such as weight gain, high blood pressure, diabetes, infections, mood problems, trouble concentrating, and increased blood clotting. These symptoms are seen in many other disorders as well, complicating the diagnosis. The reliability of tests currently used to diagnose Cushing s syndrome is not known. To test their accuracy, subjects in this study who test positive for Cushing s syndrome will be evaluated at NIH for 2 years to either confirm or refute the laboratory results. Patients between 18 and 75 years of age who are being treated at the George Washington University Weight Management Program (GWUWMP) may participate in this study. Candidates will be screened with a medical history, physical examination, measurement of body fat, blood tests, and oral glucose tolerance test. They will also complete a symptoms checklist and quality of life questionnaire. Participants will be tested for Cushing s syndrome with a saliva collection, 24-hour urine collection, and dexamethasone suppression test (DST). For the DST they will take 1 mg of dexamethasone at night and report to GWUWMP the next morning for a blood draw. All specimens blood, saliva, and urine will be tested for cortisol levels. People whose test results are abnormal will be seen at the NIH outpatient clinic for a medical history, physical examination, and blood tests; bedtime saliva collection; two 24-hour urine collections; and a 2-day 2-mg DST, followed by administration of corticotropin-releasing hormone (CRH). CRH is a naturally occurring hormone that causes cortisol levels to rise. Pre-treatment with dexamethasone prevents CRH from causing an increase in cortisol in healthy people, but not in patients with Cushing s syndrome. For the 2-day DST, the subject takes 0.5 mg dexamethasone every 6 hours for eight doses. Two hours after the last dose, CRH is injected through a catheter (thin plastic tube) inserted into an arm vein. Blood is drawn just before giving CRH to measure dexamethasone and cortisol levels and after giving CRH to measure cortisol levels. People whose test results are normal will not be seen further at NIH. Those with high cortisol levels will have repeat urine and saliva tests every 2 to 8 weeks for up to 24 months, and a 1-mg DST every 3 months during routine clinic visits at GWUWMP. People whose increased cortisol is found to be due to another condition besides Cushing s syndrome will be referred for evaluation and possible treatment. Those diagnosed with Cushing s syndrome will have standard tests to identify the tumor causing the disorder, followed by standard medical and surgical treatment.
NCT02228460
Primary Objective: To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants diagnosed with Fabry disease.
