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NCT01864174
The purpose of this study is determine if Metformin XR monotherapy in subjects with type 2 diabetes is non-inferior to Metformin IR monotherapy
NCT02096263
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.
NCT01374685
Background: \- Certain genetic mutations are linked to higher rates of cancer. It is important for people with these mutations to tell their families about it. This is because others in the family may also be at greater risk for developing these cancers. They can also pass these genes to their own children. But not much is known about how African Americans tell their family members about the results of their genetic testing. The information from this study can be used to improve genetic counseling services. These services will then be more effective in early cancer detection and prevention in the African American community. Objectives: \- To learn more about how African Americans who have tested positive for BRCA1/2 mutations tell their families about their genetic risk. Eligibility: \- African American (or of African descent) women who recently received positive test results for BRCA1/2 mutations. Design: * Participants will be screened with a basic medical history. * They will be asked general questions about their personal and family history. These include questions on marital and health insurance status, education, and income. * Those in the study will have a 45- to 60-minute phone interview. They will answer questions about how they told their family members about their genetic test results. They will also be asked what that experience was like.
NCT01492933
Background: \- Studies show that alcohol changes the amount of many brain chemicals. These changes may be related to continued drinking, craving for alcohol, and relapse. This study will use magnetic resonance imaging (MRI) to look at brain areas and brain chemistry during an infusion of alcohol. It will also study how changes in brain chemistry relate to participant reports of feeling drunk. Objectives: \- To use magnetic resonance imaging to measure the effect of alcohol on brain chemistry Eligibility: * Individuals between 21 and 45 years of age. * Participants will be either light drinkers (1 to 14 standard alcoholic drinks per week) or heavy drinkers (20 to 40 standard alcoholic drinks per week). A standard drink is a 12-ounce beer, a 4-ounce glass of wine, or a shot of liquor. * Participants must be able to go without alcohol for at least 3 days in a row without severe withdrawal symptoms. Design: * This study requires two or three outpatient visits to the NIH Clinical Center. * Participants will have a physical exam and medical history. Blood and urine samples will be collected. Participants' alcohol drinking habits will also be assessed to determine whether they may have an alcohol use disorder. * At the first study visit, participants will have an infusion of alcohol. Blood samples will be collected to measure blood alcohol levels. * The MRI study visit will take place about 3 days after the first study visit. Participants will have an MRI scan of the brain, followed by an infusion of alcohol and another scan. Blood samples will be collected. * Participants will complete questionnaires before and after each infusion to measure their response to alcohol. * Heavy drinkers will come to the clinic for a third visit to discuss possible future treatment and any risky behavior associated with their high levels of alcohol use.
NCT02141503
Background: \- Alpha-mannosidosis is a rare inherited disorder. It causes problems in many organs and tissues of the body. It can occur in children and adults. Because there is no treatment for this disease, researchers want to find out more about it. Objective: \- To learn more about Alpha-mannosidosis. Eligibility: \- People ages 5-60 with Alpha-mannosidosis. Design: * Participants will be recruited from patient support organizations and medical genetics clinics. * Participants will have 3 study visits, about once a year. A final evaluation will be made after 3 years. * Participants will have a medical history and a physical exam. * Blood samples and a urine sample will be collected. * Cerebrospinal fluid will be collected. A small area of the lower back will be numbed with medicine. A thin needle will be inserted between the spine bones. About 2 tablespoons of spinal fluid will be removed. * Brain magnetic resonance spectroscopy (MRS) scans will be done at each visit. MRS uses a strong magnetic field and radio waves to take pictures of chemicals in the brain with a scanner. The participant will lie on a table that can slide in and out of the cylinder. While in the scanner the participant will hear loud knocking noises. They will get earplugs or earmuffs to muffle the sound. Medicines might be used to keep the participant asleep during the MRS. * Participants will have a skin biopsy at the first visit only. A small area of the participant s skin will be numbed. A small circle of skin will be removed with a biopsy tool.
NCT02594189
Background: Influenza A H3N2 is a flu virus. Symptoms include fever, cough, and runny nose. It can also be more serious. Researchers want to know more about how influenza causes disease in people. They hope to develop new vaccines and treatments for flu infection. Objective: To find the smallest amount of Influenza A H3N2 virus that causes a mild to moderate flu infection in healthy people. Also, to study the body s immune response to this virus and how the infection develops. Eligibility: Healthy people ages 18 50 who are: Non-smokers or non-habitual smokers Willing to not smoke for at least 9 days Design: Participants will be screened under NIAID protocol #11-I-0183 Participants will stay at an isolation unit at the clinic for at least 9 days. They will remain in the isolation unit except for study-specific activities. The influenza virus will be sprayed into the nose. Participants will be monitored 24 hours a day. They will have tests, including: Medical history Physical exam Daily questionnaires about symptoms Blood and urine tests Nasal wash and swab: A small tube of salt water is placed in the nose to wash it. It then collects the fluid. Or the inside of the nose is rubbed with a swab. ECG: Measures the heart s electrical signals ECHO: Sound waves take pictures of the heart PFTs/Spirometry: They will blow into a machine that measures the air they blow. Participants will be discharged after they test negative for influenza A. Participants will return to the clinic for 4 follow-up visits over 8 weeks. They may complete questionnaires at home.
NCT00025857
The purpose of this study is to use brain imaging technology to examine the brain activity of adolescents with post-traumatic stress disorder (PTSD) and/or major depressive disorder (MDD) before and after treatment. Adults with PTSD or MDD exhibit abnormalities in the structure and function of certain parts of the brain. Although PTSD and MDD are psychiatric disorders that often emerge in childhood, the relationship between these disorders and brain structures has not been thoroughly studied in adolescents with the disorders. This study will use functional magnetic resonance imaging (fMRI) to study the parts of the brain that are involved in PTSD and MDD in adolescents. Adolescents with PTSD and/or MDD will be enrolled along with healthy adolescents with or without a history of abuse. Healthy adults will also be enrolled. Participants will be screened with a physical examination; blood tests; and interviews about mood, general degree of nervousness, and behavior. Adolescents and their parents will be interviewed separately and together. Following the interviews, participants will undergo psychological tests. Participants with PTSD and/or MDD will have two weekly sessions of talk therapy. Participants who continue to experience PTSD or MDD symptoms after the talk therapy may continue the talk therapy alone, begin treatment with fluoxetine (Prozac ) alone, or begin fluoxetine in addition to the talk therapy. Participants who take fluoxetine will have blood collected before treatment and 8 weeks after treatment has begun. If participants do not respond to the treatment, the treatment will be stopped and the participants will be offered another treatment. Participants who respond to treatment will continue treatment at NIH until a referral to an outside physician is made. Depending on the experiment in which they are enrolled, participants will undergo one or four MRI scans. Participants who will have four MRI scans will undergo the scans on separate days. During the MRI, participants will complete tasks on a computer. Saliva samples will be collected before and after the scans. Participants with PTSD and/or MDD will collect their saliva one or two days before the MRI scan.
NCT01264029
Background: * New weight-loss intervention programs are being studied to determine their effectiveness in helping overweight and obese individuals reach a healthy weight. However, these programs often have not been tested against each other, and researchers are interested in determining which interventions are most effective both immediately and over the long term in promoting and maintaining weight loss. * Mindful Tai Chi is a combined form of the meditative martial art tai chi and the practice of mindfulness meditation. Tai chi and mindfulness meditation both have common philosophical underpinnings that address health promotion and well-being by applying the skill of non-judgmental awareness on a moment-to-moment daily basis. More research is needed on whether Mindful Tai Chi and mindfulness meditation can help improve various health factors in overweight and obese individuals. Objectives: \- To compare the effects of Mindful Tai Chi, mindfulness meditation, walking, or a discussion group on the weight and well being of overweight and obese participants. Eligibility: \- Healthy individuals at least 18 years of age who are either overweight or obese (body mass index between 25 and 40), have a sedentary lifestyle (have not engaged in more than 1 hour of aerobic exercise per week within the last month), and are willing to commit to a specific weight-loss intervention program. Design: * This study involves four visits for collecting information and 12 weeks of research study activities. * During the first visit, participants will hear information about the study and may ask any questions. They will be screened with a medical history and physical examination, and those eligible will be assigned to one of the four study groups: Mindful Tai Chi (MTC), Mindfulness Meditation (MM), Mall Walking (MW), or Weekly Discussion (WD) group. * For the second visit, participants will give blood and urine samples, receive an abdominal ultrasound, ride a stationary bicycle for 5 minutes, and fill out health-related questionnaires. * For 12 weeks, participants will be involved in the following activities depending on their group: * MTC: Class for 2 hours per week, emphasizing the meditation aspects of tai chi. Each session will include at least 20 minutes of meditation. Participants will receive written instructions and an accompanying DVD in comparable formats specifying a minimum of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a workshop for mindfulness skill application in daily activity. * MM: Class for 2 hours per week of mindfulness meditation. Participants will receive written instructions and an accompanying DVD in comparable formats specifying a minimum of 30 minutes of daily home assignment. In weeks 2 and 8, participants will have a workshop for mindfulness skill application in daily activity. * MW: Participants will meet at a designated mall location once a week for 2-hour walk. * WD: Participants will meet at the National Institutes of Health for weekly weight-loss discussion. * For the third and fourth visits, participants will receive the same procedures as those used in the second visit. These visits will occur at the end of the 12-week activity period and at a 3-month follow up visit.
NCT00813228
Patients with diabetes have high blood sugar levels (hyperglycemia) because pancreatic beta-cells no longer produce sufficient insulin. Insufficient beta-cell function can be caused by an autoimmune killing of the beta-cells in type 1 diabetes (T1D), or by poorly understood mechanisms in type 2 diabetes (T2D). Glucagon-like peptide-1 (GLP-1) improves function of the insulin-producing beta cells, but GLP-1 has a very short circulating half-life because it is cleaved by the enzyme dipeptidyl peptidase IV (DPP-4). One current treatment being used to improve glycemia control in patients with T2D is sitagliptin, an inhibitor of DPP-4. By inhibiting DPP-4, sitagliptin increases GLP-1 levels, resulting in improved beta cell function. Sitagliptin is now being tested in individuals with new-onset T1D to determine whether it may help to preserve beta cell function. Because T1D is a disease in which the immune system destroys the insulin-producing beta cells in the pancreas, we wish to determine if and how sitagliptin alters immune function. Sitagliptin has been shown by Merck to be safe and effective with no overt immuno-toxicities. However, several lines of evidence suggest that DPP-4 inhibitors such as sitagliptin could be immunomodulatory. This randomized clinical trial will study immune function in healthy volunteers given short-term (4 week) treatment with either sitagliptin or placebo. During the study, we will take blood samples at various time intervals before, during and after treatment. We will compare the immune response with and without sitagliptin treatment using blood samples from healthy individuals. We will measure changes in the magnitude and type of immune responses. The study period is nine weeks. The study s primary outcome will be changes in blood plasma levels of a protein marker associated with decreased inflammation: Transforming Growth Factor Beta 1 (TGF beta 1). In addition, we plan to use these blood samples to measure sitagliptin s effect on expression levels of several cytokines (immune proteins). We will also measure the level of proliferation in stimulated PBMCs (blood immune cells) and gene expression in whole blood after sitagliptin treatment.
NCT00001564
Arm A: Peripheral blood apheresis by harvesting chemotherapy-naive T cells and populations enriched for professional APCs. T cells and APCs are separated from the apheresis product using countercurrent centrifugal elutriation and a monocyte rich fraction is collected. Autologous T cell transplantation during immunotherapy. Arm B: Cell harvesting is performed as soon as possible. Both Arm A and B: Patients receive intravenous infusion of irradiated peptide-pulsed antigen presenting cell vaccination (APC) products as well as intramuscular injection of influenza vaccine on the same day. Recombinant human IL-2 is administered within 4 hours of the peptide pulsed vaccine by continuous intravenous infusion for 4 days per week for 3 successive weeks. Primary toxic effect of this therapy is expected to be related to the IL-2 therapy. Patients with Grade 2 neurologic or cardiac or any Grade 3 or 4 toxic effects will discontinued IL-2 therapy. If toxic effect is not resolved in 72-hours, the patient may remain on study but will not receive any further IL-2.
NCT00923273
Background: The drug pemetrexed is used to treat non-small cell lung cancer (NSCLC) that does not respond to standard therapy or that has recurred after standard therapy; however, only 9 in 100 patients respond to pemetrexed. Sirolimus is a drug that blocks a protein in cells called mammalian target of rapamycin (mTOR). In cancer cells, mTOR is active when it should not be, allowing the cells to grow uncontrollably. This protein is unusually active in many cases of NSCLC. By blocking the activity of mTOR, sirolimus may make the cancer cells more responsive to treatment with pemetrexed. Objectives: To determine if sirolimus in combination with pemetrexed is safe and well tolerated in patients with NSCLC. To determine the highest safe dose of pemetrexed combined with sirolimus. To look at the ability of sirolimus and pemetrexed to fight NSCLC. To learn how the body eliminates sirolimus and pemetrexed. Eligibility: Patients 18 years of age and older with NSCLC whose disease does not respond to standard therapy or has recurred after treatment with standard therapy. Design: Biopsy before treatment starts, if the tumor is easy to reach by bronchoscopy or can be done by needle biopsy. This procedure is optional. Drug treatment, as follows: * Day 1: Intravenous (through a vein) infusions of pemetrexed. Small groups (3 to 6) of patients are given pemetrexed at a certain dose level. If the first group experiences no significant side effects, the next group receives a higher dose. This continues in succeeding groups for up to five dose levels until the maximum tolerated study dose (highest dose that patients can be given safely) is determined. * To lessen the side effects of pemetrexed, patients also receive a Vitamin B12 injection every 21 days, folic acid tablets daily, and dexamethasone tablets twice a day the day before, the day of, and the day after pemetrexed infusions. * Days 1-21: Sirolimus tablets by mouth. Evaluations during the treatment period: * History and physical examinations, blood and urine tests, electrocardiogram. * Disease evaluation with computed tomography (CT), positron emission tomography (PET) or magnetic resonance scans (MRI) scans....
NCT02268942
This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database. All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.
NCT00085449
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of alemtuzumab, fludarabine, and melphalan with or without cyclosporine, mycophenolate mofetil, and total-body irradiation before donor peripheral blood stem cell transplant and to see how well they work in treating patients with relapsed or refractory hematologic cancer.
NCT02135692
This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy are individuals at greatest risk of serious deterioration of their health status. In order to target individuals at greatest risk for serious deterioration of their health status, only subjects from the MEA115661 study with a history of life-threatening or seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility criteria for the study will be offered the opportunity to consent for this study of up to 128 weeks in length (including the Follow-Up Visit). This study will give opportunity to extend the collection of clinical data for long-term use and further assess the sustainability of efficacy in a population likely to experience significant loss of asthma control and the need for higher doses of systemic steroids if returned to SOC only.
NCT03076970
This is a randomized, double-blind, three-period, cross-over study to investigate the effect of sumatriptan (Imitrex) 100 mg on the pharmacodynamics and pharmacokinetics of lasmiditan 200 mg.
NCT03580460
One population of tobacco users that is severely affected by the consequences of smoking is people living with HIV (PLWH). Between 40-84% of PLWH smoke, a percentage that has remained constant since the first studies of smoking in HIV were conducted in the 1990's. Overall, smoking related morbidity and mortality is also greatly increased among PLWH smokers. Compared with PLWH nonsmokers, PLWH who smoke have more than 5 times the risk of non-HIV-related mortality and almost 4 times the risk of all-cause mortality. Compared with the general population, incidence ratio of smoking related cancers (eg, lung, head, neck, bladder and esophageal) is more than 5 times higher. At a critical time when advances in HIV care are providing an opportunity for prolonged life, smoking is significantly impeding the health of PLWH. To produce meaningful changes in smoking, however, treatment will have to be acceptable and engaging to this population as well as feasible and sustainable to implement in a busy clinic. Novel technology-based interventions that incorporate evidence-based behavioral and pharmacologic interventions for smoking and are culturally tailored offer real solutions to these implementation barriers. Research shows that internet- or computer-delivered interventions (CDI) that are tailored and interactive can be efficacious in reducing smoking and are significantly more effective than usual care or written self-help materials. CDIs can also be readily adapted to different sociodemographic characteristics of a patient population because content is modular and menu driven. Moreover, technology-based interventions appear as effective as counselor-delivered interventions in reducing smoking. This growing body of evidence strongly suggests that these interventions offer promise in reducing smoking, the potential to reach significantly more patients, and the ability to overcome barriers of cost, implementation, and cultural nonspecificity. The goal of this pilot study is test to examine feasibility, acceptability of a computer-delivered smoking cessation intervention for PLWH, and to determine if intervention participation results in increased readiness to quit smoking and increased confidence in ability to quit smoking.
NCT02935699
This is a multicenter, parallel group, randomized, double-blind, active controlled, Phase III clinical study of cetirizine injection, 10 mg/mL, compared to diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent) with acute urticaria requiring treatment.
NCT00908752
The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.
NCT02034058
The primary objective of this study is to evaluate the rate of stroke and/or death in patients treated with the Wingspan Stent System, according to the Indications for Use, within 72 hours post procedure.
NCT03040479
This is a multicenter, open-label, non-randomized, parallel-group, single dose study. This study will enroll up to 24 participants and will include 2 hepatic impaired participant groups and one group of control participants with normal hepatic function.
