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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.
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.
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.
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.
NCT00797095
The Health Behaviors in School-age Children (HBSC) study is a consortium of investigators from 40 predominantly European and North American countries who conduct a common survey of early adolescent health behaviors every 4 years. The survey gathers information about nutrition, dieting practices, physical activity, injuries, violence, relationships with family and friends, perceptions of school as a supportive environment, alcohol and tobacco use and drug use among adolescents, and about the communities in which students live. The U.S. sponsors of the survey are the National Institutes of Health and the Health Resources and Services Administration. This is the fourth survey done in the United States. The objectives of the international HBSC study are: * To assess the prevalence of early adolescent health behaviors * To identify psychosocial factors associated with adolescent behaviors * To provide an opportunity for analyses of cross-national comparisons * To provide an opportunity for analyses of trends in the U.S. and cross-nationally In addition to the above, the survey includes additional questions designed to provide information about areas of specific national interest, including the following: * To assess the association of school, family, peers, and other environmental factors on health behavior and health status * To assess the prevalence and identify factors associated with obesity, diet and physical activity * To assess the prevalence and identify factors associated with bullying and risk behaviors. This is the fourth U.S. administration of the HBSC survey, previously administered in 1997-1998, 2001-2002, and 2005-2006. About 16,000 students in grades 5 thorough 10 at randomly selected public and private schools across the United States complete a 30- 40-minute survey. The questionnaires are anonymous; students are instructed not to put their name on the survey. When they finish the survey, they place it in an envelope and seal it. The envelopes are then put in a box. Reports do not include the names of participating counties, cities, school districts, schools, or students. The information collected from U.S. school children is compared with similar information collected from school children in 40 other countries. The survey is used to help set national priorities for school and youth programs, as well as to monitor the progress of these programs.
NCT01212042
Respiratory infections have a high associated morbidity and mortality, especially in immunocompromised patients. To initiate effective treatment of respiratory infections, it is essential that a rapid and thorough laboratory analysis of respiratory specimens be performed, given the wide range of pulmonary pathogens that can be detected in this population. Conventional microbiology is time-consuming and cumbersome, and the capability of local laboratories to assess specimens for rare or unusual pathogens is often limited. This study will evaluate if a newer technology can be effectively utilized in the identification of a broader range of infectious agents relative to conventional procedures. Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical specimen. The technology has had limited clinical application, but early studies have shown its effectiveness in accurately identifying a large number of viral and bacterial organisms. In contrast to conventional microbiological procedures based on phenotypic traits (growth characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to detect and identify the species, serotype/subtype, or strain of the infectious agent. Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage, BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be analyzed using the customized microarray chip. The specimens will be collected as part of the patients routine clinical care. The results of the TessArray microarray analysis will not be available to the clinician and therefore will not have any effect on the clinical care of the patients. The results of the microarray analysis from each site will be compared to that site s clinical laboratory results, and the data will be analyzed by site.
NCT00001426
A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.
NCT00849173
Endometriosis, a condition in which the lining of the uterus grows on nearby tissues, is a common condition that affects women of reproductive age worldwide. The diagnosis of endometriosis is usually made at surgery. The most common symptom is pelvic pain. This pain may occur at the same time as menstrual bleeding, at other times of the cycle, or during or after sexual intercourse. Previous studies reveal the diagnosis of endometriosis is often delayed between 8 and 12 years after the first symptoms. Women with chronic pelvic pain report a lower quality of life. No studies, however, have been conducted to assess whether women with endometriosis-related pelvic pain are affected differently than those with pelvic pain from other or no identifiable causes. This large-scale study is designed to gather prospective epidemiological data on the impact of and risk factors for endometriosis across countries worldwide. A study of this scale and scope has never been performed; it is anticipated that the study will provide novel insights into the effects of the condition and associated symptoms on women s lives across different countries, as well as explore differences in the effects of various potential risk factors. This is an international study conducted at more than 20 sites worldwide and coordinated by Oxford University in the United Kingdom. At the National Institutes of Health, 250 premenopausal women between 18 and 45 years of age who are having their first diagnostic laparoscopy or laparoscopy for tubal sterilization will participate. None will have had a prior diagnosis of endometriosis through surgery. Women will be informed about the study when their laparoscopy is scheduled. Procedures * Patient completion of an online questionnaire before scheduled surgery. The following will be assessed by the questionnaire: * Quality of life * General gynecologic and medical history * Family history * General information * Use of health care services * Risk factors * Surgeon completion of questionnaire about surgical findings. * Follow-up: Women who consent will be contacted every 1 2 years.
NCT00257907
This study will examine how the immune system responds to infection with Mycobacterium tuberculosis bacteria (bacteria that cause tuberculosis) in order to better understand how the germ produces infection and how the immune response might work to control the infection. Only about one in 10 people infected by M. tuberculosis become sick, sometimes years or even decades after exposure. It is not known why some people become sick and most do not, but the immune system of people who never develop disease may be better able to control the bacteria. This study will evaluate the latent form of M. tuberculosis infection to further the understanding of the immune mechanisms - particularly the role of certain white blood cells - involved in the disease process. Healthy volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, family history of medical conditions, sexual history, history of drug use, physical examination and blood tests, including a test for HIV. People in Mali, West Africa, and in local health clinics in the United States may participate. At the start of the study, participants have blood tests and a tuberculin skin test (PPD test), which indicates whether a person has been exposed to tuberculosis bacteria. For the PPD, a tiny amount of liquid containing dead tuberculosis antigen is put under the skin of the forearm with a needle. The antigen cannot cause infection or disease. After 3 days, participants have another blood test and the site of the tuberculin test is examined for swelling that would indicate a positive result. Participants with a positive PPD have a chest x-ray to check for tuberculosis disease. Those whose x-ray is also positive are withdrawn from the study and referred to their doctor for evaluation and treatment. Those whose x-ray is negative return to the clinic within 3 weeks of the tuberculin test to give another blood sample. Participants whose PPD is negative have a second tuberculin test 10 to 21 days later and return 3 days after the test to determine if it is still negative or if it is positive. (Some people who are negative after the first test may test positive after the second procedure.) Those whose test is still negative end their participation in the study at that time. Participants whose second PPD is positive have a chest x-ray as described above, and those with a negative chest x-ray return in 3 weeks to donate one last blood sample. The purpose of the present study is to evaluate the latent form of this infection, the prevalence of which worldwide exceeds that of active disease. Our hypothesis is that in latent tuberculosis antigen specific effector memory CD4+ T cells are responsible for the generation of clinically measurable delayed type hypersensitivity and that central memory CD4+T cells are not directly involved in this process. We base this idea on the assumption that latent tuberculosis is a state of antigen persistence and that effector memory T cells should be maintained as long as antigen/infection is present. We propose to conduct this study in Mali, West Africa and local clinics in the U.S. Tuberculosis affects 593/100,000(2) individuals in Mali and most have been exposed to the disease. Additionally it would be important to evaluate the same parameters locally as latent infection is one of the major factors for reactivation tuberculosis in this country. Patients would be enrolled in 4 major groups: HIV-/TST- (Group A), HIV-/TST+ (Group B), HIV+/TST+(G roup C) and HIV+/TST- (Group D). To evaluate this hypothesis we plan to enroll between 100 - 300 patients over the course of 2 years from both countries. Blood samples before and at predetermined time points after the application of Purified Protein Derivative (PPD) will be obtained to determine the fraction of CD4+ T cells which produce interferon gamma in response to stimulation with PPD with a 16hr antigen stimulation assay. Appropriate staining will be done to ascertain the phenotype as well as cytokine production (Interferon gamma,( IFN gamma), Interleukin 2 (IL2) and Tumour Necrosis Factor ( TNF)). Additionally lymphocyte proliferation will be studied using 5-(and-6)-carboxyflouorescein diacetate succinimidyl ester (CFSE.) In conducting this study we hope to further the understanding of the immune mechanisms involved, particularly mechanisms of T cell memory, which would provide insights into TB and HIV pathogenesis. We also believe that understanding these mechanisms could lead towards establishment of surrogates for immunity in TB vaccine studies, which could enhance vaccine trial design. It might also help in understanding better the immunological dynamics of tuberculosis co-infection in individuals with HIV infection.
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.
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.
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....
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.
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.
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.
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.
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.
