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Showing 13841-13860 of 19,983 trials
NCT00988208
The purpose of the study is to determine whether lenalidomide is safe and effective for use in combination with docetaxel and prednisone for the treatment of subjects with metastatic Castrate-Resistant Prostate Cancer. The addition of lenalidomide to docetaxel and prednisone is proposed to increase the life expectancy of these subjects.
NCT01369966
Background: \- Smoking is associated with serious health risks. People who have mental illness are more likely to smoke. Researchers are studying the brain circuits linked with smoking and nicotine craving. This study will look at whether a specific brain circuit can explain the high rate of smoking in people with schizophrenia. Objectives: \- To study brain activity in smokers and nonsmokers with and without schizophrenia, as well as their family members. Eligibility: * Current smokers (at least 100 cigarettes in the past year) and nonsmokers between 18 and 62 years of age in one of the following groups: * Have been diagnosed with schizophrenia. * Family members of those with schizophrenia. * Healthy adults with no history of severe mental illness or brain trauma. * Family members of the healthy adults. Design: * People in the study will be screened with a physical exam, medical history, questionnaires, and blood tests. * They will have up to three visits: the screening visit and two study visits (each given 1 year apart). * At the first study visit, those taking part will be trained in the tests they will do during the magnetic resonance imaging (MRI) scan. Then they will have the MRI scan. * After the first study visit, current smokers will receive phone calls from the study researchers every other month for 1 year. They will be asked about their smoking habits. * At the second study visit, current smokers and some nonsmokers will have another MRI scan and the same tests as before. * Current smokers will receive a final phone call 1 year after the second study visit. They will be asked to give information about their smoking habits.
NCT01365988
Objective- To use fMRI to compare brain activity at rest and during memory and decision making tasks in normal children and in children exposed in utero to drugs of abuse. Study population- All participants will be 14-20 year-olds enrolled in an ongoing longitudinal follow up study of children exposed to drugs of abuse in utero funded by NIH. A subgroup of this study cohort will be invited to participate based on added criteria needed for scanning studies, such as absence of metal in the body, no significant CNS disease, and ability to tolerate the scanning environment. Design- Participants will undergo fMRI scans while performing a memory task, a decision making task and at rest. Data from participants in the current study may be combined with those from a previous study (NIDA protocol 417) which now reside in our repository protocol, 8002 and NIDA protocol 455. Outcome measures- The primary outcome measures will be the difference in BOLD fMRI activation between drug-exposed participants and those without prenatal exposure to drugs of abuse.
NCT00342693
Background: * An inadequate filtering system at the Mayak nuclear weapons production facility in Ozyorsk, Russia, allowed the release of various radioactive materials, particularly I-131 (radioactive iodine) into the city's atmosphere during the 1950s. * A recent pilot study found a higher prevalence of thyroid nodules in Ozyorsk residents who were exposed to the radiation in childhood during years of heavy atmospheric emissions (1952-1953) than in children exposed in later years (between 1967 and 1991) when there were almost no radioactive releases. * Understanding the role of I-131 in the development of thyroid disease is important because I-131 is commonly used in medicine (e.g., to treat hyperthyroidism and thyroid cancer and to diagnose thyroid disease), and it is the major source of thyroid gland exposure in fallout from atomic bomb explosions, nuclear power plant accidents, and atmospheric venting from plutonium manufacturing facilities. Objectives: -To expand the pilot study to include 350 Ozyorsk residents who were exposed in childhood to moderate levels of radiation in order to evaluate thyroid disease in relation to the dose of I-131 exposure. Eligibility: -People who were born and living in Ozyorsk, Russia between 1954 and 1955, the period of mild radioactive releases from the Mayak nuclear weapons plant. Design: * Participants' thyroid gland and structure are examined with an ultrasound examination and blood tests. * Participants with a possible thyroid gland disorder are referred to specialists for additional diagnostic procedures.
NCT01611402
Background: \- Tuberculosis (TB) infection is particularly deadly when it happens in people who are also infected with the human immunodeficiency virus (HIV). However, not much is known about how these two infections affect each other. Some people who have HIV or TB infections develop health problems after they start taking either HIV or TB medications or both. These drugs can improve the body s ability to fight infections, but sometimes this sudden improvement can make the infected person initially become sicker. Researchers want to study how these infections affect the immune system and the gene expression of people who have TB and may or may not have HIV, to see if there is a pattern of gene expression that may predict whether people starting treatment may get sicker initially. Objectives: \- To study the gene expression and immune systems of people with TB who may or may not also have HIV. Eligibility: * Adults at least 18 years of age who have tuberculosis. * Participants will be drawn from study sites in the United States and China. Design: * Participants will be divided into three study groups. The first group will have TB but not HIV. The second group will have both TB and HIV that have not been treated. The third group will have both TB and HIV that are currently being treated. * All participants will have a single study visit. Blood samples will be collected at this visit. A medical history will also be collected. * No treatment will be provided as part of this study.
NCT01437033
Background: \- Some types of cancer, like cancer of the esophagus, are difficult to detect at an early stage. A possible detection method involves collecting breath samples to look for chemicals that may be signs of cancer. However, more research is needed to determine how different chemicals appear in different breath samples. This study will involve healthy volunteers. Objectives: \- To study chemicals appearing in breath samples of healthy volunteers. Eligibility: \- Healthy volunteers between 30 and 60 years of age. Design: * Participants will fast overnight (midnight to morning) and then provide two breath samples taken 5 minutes apart. * Breath samples will be collected on days 1, 49, and 98 of the study
NCT01381757
Background: -Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed with a test that is fast and inexpensive but not always accurate. The purpose of this study is to test a new method for diagnosing TB, called the microscopic-observation drug-susceptibility (MODS) test. The MODS test takes 7 days to show results. The test also gives information on which drugs will work best in each case. Objective: -To test a new method for diagnosing tuberculosis called the microscopic observation drug susceptibility test. Eligibility: * Participants must be 12 years of age or older. * They must have a diagnosis of TB from a sputum smear, or have symptoms of TB and an x-ray indicating that TB is present. Design: * Participants will take part in the study from 6 months to 21 months and be assigned to one of three groups, depending on what type of TB they have. * At the first visit, researchers ask questions about general health and symptoms of TB. They check vital signs, draw blood, and ask for a sputum sample. The blood is used to check for HIV infection and for the number of CD4 cells, which measures the severity of the HIV infection. * The 2-, 5-, and 6-month visits are similar to the first. Those who do not have multidrug-resistant (MDR) TB will end their participation after the 6-month visit. MDR TB is tuberculosis that has not responded to isoniazid and rifampicin. Participants with MDR TB will remain in the study for 21 months. * No treatment is provided as part of this study.
NCT01263015
The purpose of this trial is to assess the non-inferior antiviral activity of GSK1349572 50 mg plus Abacavir/Lamivudine once daily versus Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (ATRIPLA® a trade mark of Bristol-Myers Squibb and Gilead Sciences LLC) over 48 weeks; non-inferiority will also be tested at Week 96. This study will be conducted in HIV-1 infected ART-naïve adult subjects. Long term antiviral activity, tolerability, safety, and development of viral resistance will be evaluated.
NCT03487991
We are evaluating a model where trauma exposure and threatening environments elicit nocturnal vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal during sleep which in turn stimulates secretion of atherogenic humoral factors, arterial stiffening, and cardiovascular disease risk. We will examine the roles of pre-sleep cognition using a questionnaire and real time assessment, and modifiable strategies for coping with sleep disruptive cognitions. We will then evaluate the impact of providing personalized feedback and recommendations based on study observations on how participants cope with potentially sleep disruptive cognitions and sleep efficiency in a randomized trial.
NCT01505725
Background: \- Researchers have been studying behavioral components of nicotine addiction by looking at how drugs have a reinforcing effect, connecting the stimulation provided by the drug (nicotine) to the behavior that produces it (smoking). Based on previous studies, researchers are interested in learning more about how nicotine affects current smokers' responses to psychological tests and smoking-related cues, and in studying whether certain kinds of genetic background may affect smokers' responses to these kinds of studies. Objectives: * To compare the effect of nicotine versus denicotinized cigarettes during specific psychological tests. * To compare the effects of smoking cues versus neutral cues on craving, mood, and autonomic response. * To study the effect of genes on nicotine reinforcement and smoking-cue reactivity. Eligibility: \- Individuals between 18 and 64 years of age who are current smokers (at least 10 cigarettes per day for at least 1 year) and are not currently interested in reducing their smoking or seeking treatment for tobacco dependence. Design: * Pilot session: * Participants will practice smoking using the measuring equipment that will be used in the study. * After successful practice, participants will read or listen to music for 1 hour, during which they are not allowed to smoke. * After the 1-hour period, participants will sample study cigarettes that have different levels of nicotine, and will be asked to guess whether the cigarettes are normal study cigarettes or denicotinized cigarettes. * Baseline session: * Blood, urine, and breath samples will be taken at the start of the session. * Participants will smoke part of an initial cigarette, and then will read or listen to music for 1 hour, during which they are not allowed to smoke. * After the 1-hour period, participants will give another breath sample and will complete questionnaires about mood and concentration levels. * Trial sessions: * Participants will smoke study cigarettes, and will be asked to either respond to questions about perceived nicotine levels in the cigarettes or press a lever for the chance to be rewarded with additional puffs of the cigarette. After the session, participants will give another breath sample and will complete questionnaires about mood and concentration levels. * Participants will also participate in cue-reactivity sessions to test the body's physiological response to smoking cues (a pack of cigarettes) and neutral cues (a pack of unsharpened pencils). After the session, participants will complete questionnaires on mood and concentration 15, 30, 45, and 60 minutes after the session. * At the conclusion of the last experimental session, participants will discuss the study with researchers, and may receive a referral list of smoking treatment programs.
NCT01867359
Background: \- Researchers are interested in learning more about dementia and its causes. They want to look at the genetic basis of dementia. Identifying genetic aspects of dementia may help provide better tests and treatments for it. It may also show rare gene variants that can cause or alter a person's risks for developing dementia. This study will look at people who have dementia, their family members, and healthy volunteers. Objectives: \- To study genetic influences on dementia. Eligibility: * Individuals who have been diagnosed with dementia. * Family members of individuals who have been diagnosed with dementia. * Healthy volunteers at least 18 years of age. Design: * Participants will be interviewed and answer questions about their medical history. They will also provide general information on the relatives' medical histories. * Participants will provide a blood sample for genetic testing. * Participants will remain on the study for up to 10 years. They will have regular visits to monitor their brain health and function. * Treatment will not be provided as part of this study.
NCT01678833
Background: Although some treatments for substance abuse are considered effective for some people who are drug dependent, many others do not benefit as much over time. Researchers are working to find out what characteristics predict treatment response. They also want to determine how to design treatments that are more effective for a greater number of substance abusers. This pilot study involves providing drug addicts with cognitive behavioral therapy (CBT), a treatment considered to be one of the most effective in reducing substance-abuse, to identify ways in which the brain works that may predict and explain treatment effects. A comparison group will be included that receives only standard psychotherapy or talk therapy. This approach will enable researchers to determine what factors might be interfering with favorable treatment outcomes and how to refine or develop new treatments that work well for more people. Objectives: \- To identify individual characteristics which predict and explain the effects of CBT in people with opiate dependence. Eligibility: * Males between 18 and 60 years of age who are dependent on opioids (such as heroin). * Participants must be willing to take buprenorphine and receive substance abuse counseling. Design: * Participants will be screened with a physical exam and medical history. * Researchers will ask questions about participants ability to cope in certain situations, along with questions about drug use and lifestyle issues. These questions will be asked twice, before and after completing treatment. * Participants will be placed into one of two groups. One group will have CBT twice a week for 8 weeks. The other group will have standard counseling twice per week. Both groups will take buprenorphine as part of the drug abuse treatment. * Participants will have other tests during this study. They will have imaging studies to look at brain function. These studies will test thinking and decision making.
NCT00618631
Background: * Tobacco smoking is one of the most preventable causes of morbidity and mortality in the world, but the addictive property of nicotine is such that fewer than 10 percent of people who attempt to quit smoking remain tobacco-free after 1 year. Researchers are studying the addictive properties of nicotine in an attempt to develop more successful medication therapies for smoking cessation. * Nicotine acts on chemical receptors in the brain, including opioid receptors that affect the perception of pain. Repeated nicotine administration can cause adaptations in the brain s opioid receptors, which heightens the addictive properties of nicotine and increases the likelihood and severity of withdrawal symptoms associated with smoking cessation. Researchers are interested in using positron emission tomography (PET) scanning to study brain chemical responses to nicotine in current smokers and nonsmokers. Objectives: * To study brain chemical activity related to cigarette smoking and nicotine administration. * To compare the brain chemical activity of current daily smokers with that of nonsmokers. Eligibility: \- Individuals 21 to 50 years of age who are either current smokers (10 to 25 cigarettes daily for at least 2 years) or have had some exposure to tobacco but have never smoked regularly (may have had a maximum of 20 cigarettes in their lifetime and none in past year). Design: * Eligible participants will undergo initial medical and psychological screening and neuropsychological testing before beginning the main phase of the study. Participants will be required to abstain from alcohol and drugs (except caffeine, nicotine, and prescription drugs) for 24 hours before each session, and smokers will refrain from smoking after midnight on the night before each session. * Session 1: Participants will answer questions about nicotine craving and withdrawal symptoms, followed by a magnetic resonance imaging (MRI) scan to provide baseline information about brain activity. * Session 2 and 3: Participants will answer questions about nicotine craving and withdrawal symptoms, and then will smoke one cigarette (either active nicotine or placebo). Researchers will document participants consumption of the cigarette. After the cigarette is smoked, participants will have a PET scan. Blood samples will be drawn during the PET session.
NCT03139097
This study will establish reference range intervals for the Quantra System, a next-generation diagnostic platform that provides whole blood coagulation testing at the point-of-care.
NCT01867346
Background: \- The Baltimore Longitudinal Study of Aging (BLSA) is a long-term study of human aging. To see how the brain changes with age, researchers will study BLSA participants who are at least 60 years old. In particular, researchers are looking for early markers of possible Alzheimer's disease and other conditions that cause memory loss. To do so, they will give tests of memory and brain function, and stay in close contact with participants. Objectives: \- To study cognitive changes that occur in normal aging and in people who develop memory problems. Eligibility: \- Individuals at least 60 years of age who are participating in the BLSA. Design: * There are three parts to this study. These study procedures will be done under the usual BLSA guidelines. * Participants will take paper and pencil tests. The tests measure skills such as language, attention, memory, and problem solving. They will also ask questions about emotions and feelings. * Participants will give the name and phone number of a person who knows them well and sees them often. Researchers will ask this person to fill out questionnaires on the effects of aging on the participant. These questions will monitor the participant's memory and ability to function independently. * Participants will have regular phone calls between study visits. These calls will help to keep their information up to date. * Participants will continue on this study for as long as they are able to participate.
NCT01517113
Background: \- Advancing age is associated with greater risk of heart disease. High blood pressure and hardening of the arteries also have more complications with age. Studies suggest that age-related inflammation may affect fatty tissue in the body. If this fat develops in the muscles or around the heart, it may increase risks of heart disease. Researchers will study body composition in older adults to see if age-related changes in body fat are related to higher risks of heart disease. Objectives: \- To study the relationship between fat deposits and aging, and greater risks of heart disease. Eligibility: * Participants in the Baltimore Longitudinal Study of Aging between 50 and 80 years of age. * Individuals between 50 and 80 years of age who have been diagnosed with coronary artery disease. Design: * Participants will be screened with a physical exam and medical history. * Participants will provide blood and urine samples. They will also have their height and weight measured. Waist circumference will also be taken. * Participants will have a DEXA scan to study their muscles. * Participants will have magnetic resonance imaging scans. These scans will study heart function and muscle and blood vessel health. * Participants with coronary artery disease will have catheterization. Blood samples will be collected during the procedure....
NCT01654965
This phase I trial studies the side effects and best dose of tivantinib and topotecan hydrochloride in treating patients with advanced or metastatic solid tumors. Tivantinib and topotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT01680341
This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to compare the efficacy and safety of two different titration algorithms for insulin degludec/insulin aspart (IDeg/IAsp) in subjects with type 2 diabetes mellitus previously treated with insulin glargine.
NCT02465450
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of JBT-101 in adult subjects with cystic fibrosis (CF).
NCT03228381
The objective of the BOSS Study is to assess acute anatomical and geometric annular and ventricular changes that occur when strategically positioned an external inflatable chambers are applied to the outside of the heart.
