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NCT02586506
Asthma is a chronic disease of the lungs characterized by airway inflammation, bronchoconstriction and increased airway responsiveness. Inhaled corticosteroids (ICS), alone or in combination with inhaled long-acting beta-adrenergic agonists (LABA), are considered a mainstay of treatment for treatment. For inhaled medications, the choice of inhalation device is an important consideration because an inadequate technique reduces the delivery of medicines and effects of inhalation. Therefore, the development of an easy-to-use inhaler that delivers the drug to the lungs effectively, is important. This study is designed to assess the correct use of the ELLIPTA inhaler in subjects with asthma and also to assess ease of use of the ELLIPTA inhaler, as rated by those subjects determined to be using the inhaler correctly. Study will be divided into two visits i.e. Screening/Visit 1 (day 1) and Visit 2 (Day 28 +/-2) with a phone call on Day 8+/-2 days of Visit 1 to assess safety. In this multi-center, single-arm, randomised (to receive one of two versions of the ELLIPTA inhaler Ease of Use questionnaires), open-label, placebo study, only subjects who are have never used the ELLIPTA inhaler before and have an established diagnosis of asthma and receiving asthma therapy and are able to demonstrate correct use of the ELLIPTA inhaler at Visit 1 will be considered eligible to participate in this study. Approximately 252 subjects will be screened with an expectation of 208 subjects completing the study while demonstrating correct ELLIPTA inhaler use at visit 2. ELLIPTA is a registered trademark of the GlaxoSmithKline Group of Companies.
NCT00210665
The purpose of this study is to facilitate access to trabectedin for eligible previously treated patients with soft tissue sarcoma (STS), who cannot be expected to benefit from currently available therapeutic options but who may benefit from treatment with trabectedin. The safety profile of trabectedin will be evaluated to further assess the potential risks of trabectedin treatment.
NCT00718328
Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH).
NCT01689675
Musculoskeletal sprain/strain injuries and disorders (MSID) have a major impact on health, quality of life and societal productivity. Early intervention for pain following acute MSIDs may prevent secondary complications of chronic pain, disability, reduced quality of life or lost productivity. The investigators goal is to evaluate the efficacy of a computer-based self-management intervention for reducing pain and improving function in persons treated in on-site physical rehabilitation centers. The specific aims are:1) evaluate the efficacy of a computer-based self-management intervention in reducing pain and self-efficacy and function in high risk MSID patients; 2) determine long term impact during a six month follow-up period; and 3) determine whether reductions of pain and improved function translate into reductions in lost work time days away from work, restricted work days, worker's compensation costs and re-injury rates during the 6 month follow-up. Persons with sprain/strain injuries at risk for poor pain control will randomized to either: 1) control condition - standard care in the rehabilitation center plus computer exposure or 2) standard care plus computer-based self-management pain intervention. Assessment will be at baseline, treatment completion, 3 and 6 months. The primary outcome measures are self-efficacy, pain and physical/psychosocial functioning and secondary outcome measures are days away from work, restricted work days worker's compensation costs and re-injury rates. The investigation will also provide unique and valuable information regarding patients acceptance and use of computer-based interventions following acute injury. By establishing the utility and efficacy of computer-based pain management interventions for MSID the investigators have the potential to improve the health and quality of life of persons with injuries, improve productivity and develop new methods for health care delivery.
NCT01730027
This randomised, double-blind, placebo-controlled study will evaluate the efficacy and safety of ADC3680 administered once daily as an add-on therapy to inhaled corticosteroids and when co-administered with montelukast in patients with inadequately-controlled asthma. Patients will be randomised to 3 Arms to receive ADC3680, placebo or montelukast.
NCT00062517
The purpose of this study is to increase researchers understanding of the biological basis of generalized anxiety disorder and social anxiety disorder. They will investigate how the brain activity associated with specific thoughts and feelings may play a role in these anxiety disorders. This knowledge will be used to design interventions to help those with these illnesses. To qualify for this study, participants must be evaluated via an initial telephone screening interview and material sent through the mail. Participants will then be required to make three visits to NIH. During the first visit, they will be asked questions about their general mood, degree of nervousness, thinking skills, and behavior. They will undergo a thorough physical exam, including an EKG, blood work, urinalysis, and a pregnancy test for women of childbearing potential. During the second visit, participants will spend about 2.5 hours doing various tasks while sitting and looking at a computer screen. These tasks will guide them to experience specific kinds of thoughts and emotions. Researchers will attach electrodes to the participants hands to monitor the amount of electricity conducted by the skin. The third visit will be similar to the second visit, but participants will perform the tasks while lying in a MRI scanner. Participants will be compensated up to $400 for their involvement in this study.
NCT00283894
This study will measure energy expenditure (the rate at which the body burns calories), physical activity and caloric intake in people with narcolepsy to learn more about how the risk of becoming overweight or diabetic may be affected. Healthy control subjects and people with narcolepsy between 18 and 55 years of age may be eligible for this study. Participants are withdrawn from their narcolepsy medication and undergo the following tests and procedures over 5 weeks before resuming medications. * Blood draw for genetic studies. * Collection of a cerebrospinal fluid sample. * Diet to keep subjects' weight constant. * Activity watch, using a device worn on the wrist to measure amount of movement, and an activity monitor worn at the waist to measure physical activity and caloric expenditure. * Questionnaires about sleepiness, symptoms, food intake, exercise and mood. * 24-hour urine collection and 24-hour blood draw to measure hormones. * Glucose tolerance test. The subject drinks a sugar solution and blood samples are collected through a catheter before drinking the solution and 30 minutes, 1, 2 and 3 hours after drinking it. * Startle reflex test. Subjects hear a loud noise through headphones and are asked to look at pictures. * Sleep study to evaluate sleep-related breathing disturbances and record information about sleep stages. * Indirect calorimetry test to measure how fast the body uses calories. A plastic canopy is placed over the face for several minutes to capture the air exhaled to analyze oxygen use. To measure the energy associated with meals, the same measurements are taken after the subject eats lunch. * CT scan of the abdomen to see how much fat is deposited in the abdomen, and DEXA scan of the whole body to see the percentage of fat and muscle. * Plethysmography. Participants sit in an enclosed chamber while the mass and volume of the body are measured by changes in air pressure. * Neuropsychological testing to assess thought processes. * Continuous 24-hour heart rate measurement. * Metabolic chamber. Subjects spend 24 hours in a small room to measure the amount of oxygen inhaled and carbon dioxide exhaled. * Walking/running test to assess level of physical conditioning. * Dexamethasone CRH (corticotropin-releasing hormone) suppression test and CRH stimulation test. Subjects receive eight doses of 0.5 mg dexamethasone every 6 hours for a day and a half. After the last dose, two blood samples are drawn, then a dose of CRH is injected, and then six more blood samples are drawn over the next 3 hours. * TRH (thyrotropin-releasing hormone) stimulation test. Subjects are given TRH through a vein, and several blood samples are then drawn over the next 3 hours. * Doubly labeled water test. Subjects drink a dose of "heavy" water. Urine samples are collected at 2, 3 and 5 hours after drinking and again for two 4-hour collections a week later.
NCT00955864
Background: * The uterine cervix is composed of muscle and collagen, which change as women age and under hormonal influences like puberty, pregnancy, and menopause. Yet even though knowledge of structure of the cervix (especially the collagen network) is important to detect problems that may affect pregnancy and other women s health issues, no noninvasive techniques are available to evaluate such changes. * A specially designed polarized camera attached to a conventional colposcope can be used to take cervical images. Analyzing these images may enable researchers to better visualize the collagen network in the cervix. Objectives: * To explore and gain experience with the use of a polarized imaging system to study cervical structure. * To evaluate the usefulness of a polarized imaging system in studying the cervical structure of healthy nonpregnant women. Eligibility: \- Adult females (at least 18 years of age) who are having regular menstrual cycles and are not on hormonal medications. Design: * Images will be takes from the cervix in two different phases of menstruation cycle time, one in the follicular phase (before ovulation) and another one in the luteal phase (after ovulation). * The images of the cervix will be taken with a vaginal speculum in place with the camera attached to a colposcope. The colposcope will illuminate the cervix using polarized light. Three random cervical locations will be photographed
NCT00001678
This study attempts to identify the genes responsible for rheumatoid arthritis (RA), or inflammation of the joints. It is known that genes play an important role in RA, but their number and significance have not been determined. RA tends to run in families. This study will examine the DNA (hereditary material) of patients with RA and their family members to try to determine which chromosomes(s) contain the genes responsible for the disease. Patients with rheumatoid arthritis and their family members may be eligible for this study. Participants with RA who have a brother or sister with RA will undergo the following procedures: * Review of their medical records * Medical history * Examination of the joints * Hand X-rays * Blood tests Participants who 1) do not have RA but who have a relative with the disease, or 2) have RA and a relative other than a brother or sister who has the disease will provide a blood sample or a buccal (cheek) cell sample. Cheek cells are obtained by swishing a small amount of mouthwash in the mouth or by lightly bushing the inside of the cheek with a swab or brush. The samples will be tested for rheumatoid factor, DNA studies, and HLA type (a blood type found on white blood cells). Certain HLA types have been associated with an increased risk or severity of RA.
NCT00891787
Background: * Probiotics are oral food supplements containing live bacteria that may be beneficial to a person s digestion or general health. Probiotics are available as tablets, powder, or liquid supplements and are frequently used to supplement yogurt. They are available for purchase without prescription in most supermarkets. * The bacteria in probiotic supplements commonly express sugar substances on their surface. These sugar substances are similar to group A and B blood group sugars, called antigens. These antigens determine a person s blood group. Researchers are studying the effect of probiotic supplements on the amount of blood group antibodies that are present in a person s blood. Objectives: * To determine whether taking oral probiotic supplements increases anti-A and anti-B isoagglutinins (antibodies that cause red blood cells to clump together) in healthy subjects. * To study the frequency of these effects and determine whether there is a dose-response relationship with probiotics and isoagglutinin titers. Eligibility: * Healthy adults, 18 years or older, with type A, B, or O blood. * Female participants need to have undergone menopause or have had a hysterectomy. * Individuals are ineligible if they currently donate platelets; have a history of ulcerative colitis or Crohn s disease; have had major bowel surgery; are pregnant or capable of becoming pregnant; have a bleeding or clotting disorder; have a history of a blood disorder or immune deficiency; have a history of high-risk behaviors for exposure to HIV or hepatitis B or C; have diabetes; have received vaccinations in the past 2 months, with the exception of the flu vaccine; are currently taking immunosuppressive medications; are currently taking antibiotics; or have taken probiotic supplements within the last 12 months. Design: * Researchers will conduct the following tests throughout the 28-week study: * Blood samples will be drawn every 2 weeks to measure the quantity of isoagglutinin titers. * Depending on individual results, continued blood testing may be done every 3 months for 1 year, then every 6 to 12 months for up to 5 years. * Study subjects will take a probiotic supplement at a dose of 1 to 3 caplets per day for 18 consecutive weeks according to the following schedule: * During the first 6-week period, the subject will take one probiotic tablet daily. * During the second 6-week period, the subject will take one probiotic tablet twice daily. * During the third 6-week period, the subject will take one probiotic tablet three times daily. * Control group subjects will be followed in a similar manner but will not take probiotic supplements. * The outcome measure is the percent of probiotic ingestors (the study subjects) versus control group subjects who experience a fourfold or greater rise in isoagglutinin titer. * Study subjects will receive the following financial compensation: $10 per blood sample, for a maximum of $240 if all 24 samples are collected; $100 after completing the first 6-week period; $150 after completing the second 6-week period; and $200 after completing the third 6-week period. * Control subjects will receive $10 per blood sample, for a maximum of $150 if all 15 samples are collected.
NCT00382564
This study will determine the usefulness of magnetic resonance imaging (MRI) for examining the heart or blood vessels. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a metal cylinder), wearing earplugs to muffle loud noises that occur during the scanning process. MRI of the heart and blood vessels, called magnetic resonance angiography (MRA), is a developing diagnostic method that permits evaluation of arteries and veins without the use of x-rays or invasive catheterization required by conventional angiography. People 18 years of age and older with known or suspected atherosclerotic disease may be eligible for this study. Participants have blood tests and MRA scanning. The MRA takes about 1.5 to 2 hours. During part of the scan, a contrast agent may be injected into a vein to brighten the images of the heart and blood vessels. Subjects are monitored with an electrocardiogram and are asked to hold their breath for about 5 to 20 seconds intermittently during the procedure. A CT scan may be done to confirm the MRA findings. CT uses x-rays to produce pictures of the heart and blood vessels. The subject lies on a bed during the scan and is given a contrast agent through a catheter inserted into a vein. Subjects are asked to hold their breath intermittently for about 5 to 20 seconds. A medicine called a beta blocker may be administered to slow the heart rate.
NCT00884702
Background: * The brain needs sleep to function normally, but the purpose of sleep is not understood. Brain activity decreases during sleep, so it may be that sleep is important to maintain, repair, or reorganize brain cells. In animals, the formation of brain proteins increases during sleep, and the same thing may happen in humans. * There is also evidence that learning and memory are helped by sleep, and that the synthesis of proteins in the brain are involved. Objectives: * To examine the formation of proteins in the brain while people are awake, deprived of sleep, and during sleep. * To look at the formation of proteins in the brain while awake or asleep and following learning a task. Eligibility: * Healthy volunteers between 18 and 28 years of age. * Volunteers must not have psychiatric, neurologic, or sleep disorders or certain types of vision problems, and must be able to undergo imaging studies. Design: * Study Part I (protein formation in waking, sleep deprivation, and sleep): * Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior to admission. * Participants will have physical and psychological examinations, along with a blood sample. * After admission participants will have three positron emission tomography (PET) scans to study protein formation and one magnetic resonance imaging (MRI) scan over the course of two days. * Participants may be asked to stay awake for as long as 20 hours and will be monitored throughout. * Participants will be able to sleep overnight after they complete the required scans and monitoring, and will be discharged the following morning. * Study Part II (protein formation in waking and sleep combined with a learning task): * Participants will wear an actigraph (a unit to record motor activity) for 2 weeks prior to admission. * Participants will have physical and psychological examinations, along with a blood sample. * After admission participants may be asked to stay awake for as long as 20 hours and will be monitored throughout. * The next morning, participants will be trained to perform a computerized visual discrimination task, and will be tested 8 hours later (after sleep or after remaining awake) on the visual discrimination task. * Some participants may have PET and MRI scans as part of the study. * Participants will be able to sleep overnight after they complete the required tests and scans, and will be discharged the following morning. * Participants will receive financial compensation for their participation in these studies.
NCT00001453
Patients with Cushing disease have hormone producing tumors in their pituitary gland. Often these tumors are so small they cannot be detected by magnetic resonance imaging (MRI). The inferior petrosal sinuses are small veins that drain the blood from the pituitary gland. By taking a small sample of blood from these sinuses, doctors can differentiate a small tumor in the pituitary gland from other tumors in the body producing the hormone. Patients with Cushing disease have high levels of the hormone ACTH in the petrosal sinuses. Patients with other causes of Cushing syndrome do not have increased levels of ACTH in the petrosal sinuses. The procedure to collect blood from the petrosal sinus is called Inferior Petrosal Sinus Sampling (IPSS). The technique is very sensitive and can tell the difference between a pituitary tumor and other causes of Cushing syndrome nearly 100% of the time. However, IPSS is very difficult to perform and is only available in a few hospitals. Therefore, researchers are looking for another possible way to diagnose Cushing syndrome that would be less technically difficult and more readily available to patients. ACTH is produced in the pituitary gland as a response to the production of Corticotropin-Releasing Hormone (CRH) in the brain (hypothalamus). This study will compare ACTH levels in the internal jugular veins before and after CRH stimulation with those obtained by conventional IPSS from patients with Cushing's syndrome. Obtaining blood from the jugular veins is a simple, practically risk free procedure that could be done easily in a community hospital on an out patient basis. Researchers believe that CRH stimulation will increase ACTH production from tumors of the pituitary gland (corticotroph adenomas) so that the diagnostic information from jugular venous sampling would be equivalent to that of IPSS. This proposal to develop jugular venous sampling (JVS) with CRH stimulation as a test for the differential diagnosis of Cushing Syndrome would potentially contribute greatly to the medical care of patients with Cushing syndrome, as a less costly, safer and more widely available alternative to IPSS.\<TAB\>
NCT00074945
This study will explore factors that affect obesity and obesity-related diseases in both Caucasians and African Americans. By looking at the rate at which the human body burns calories while at rest (resting energy expenditure, or REE) and at the rate at which fat travels through the blood (fatty acid flux), this study will examine the relationship between REE and fatty acid flux, both of which are determinants of obesity. Researchers will compare the test results of Caucasians and African Americans to determine if race has an effect on the relationship between REE and fatty acid flux. Volunteers must be between 18 and 49 years of age. Equal numbers of typical weight, overweight, and obese participants will be recruited. Candidates will be screened with a physical examination, electrocardiogram, and blood tests, and will be interviewed about diet and exercise habits, family and medical history, and employment. Participants will be placed on a two-week maintenance diet (prepared by a dietician to regulate and maintain calorie consumption) and must visit an outpatient clinic for weight measurement for 10 consecutive weekdays. During the two-week diet, participants will also undergo two 20-minute computerized scans to measure abdominal and body fat. At the end of the two weeks, participants will then be hospitalized for two days to allow researchers to conduct blood tests, oral glucose tests, and a physical examination to measure REE and fatty acid flux levels for comparison.
NCT00729534
This study will examine how research volunteers experience their participation in studies in order to develop surveys to be used by research centers trying to improve the experience of their participants. People 18 years of age and older who have participated in an NIH research protocol within the past 2 years as someone with a medical condition under study may be eligible for this study. Eight participants will participate in a moderator facilitated focus group in a discussion about being in research studies. An observer audiotapes the discussion and takes written notes. The focus group discussion lasts about 1 to 1 (Omega) hours.
NCT00006073
This study will evaluate healthy normal volunteers and patients with a variety of endocrine disorders to 1) learn more about conditions that affect the endocrine glands (glands that secrete hormones) and 2) train physicians in endocrinology. Patients with endocrine-related conditions and healthy volunteers of all ages may be eligible for this study. All participants will have a physical examination medical and history. They may be required to provide blood, saliva or urine samples and undergo ultrasound (using sound waves) or magnetic resonance (using a magnetic field) imaging to visualize internal body structures. Some healthy adult volunteers will have hormone-stimulating tests to assess endocrine function. These tests measure blood hormone levels before and after injection of a synthetic form of a hormone. A device called a heparin lock, through which the hormone is injected and the blood samples are collected, is placed in a vein in the arm or hand. Blood samples are drawn before the hormone is injected and at various intervals after the injection to measure levels of the hormone. These tests, which last from 1 to 3 hours, may include the following: 1. CRH stimulation test corticotropin-releasing hormone is given to test pituitary and adrenal gland function 2. ACTH stimulation test adrenocorticotrophic hormone is given to test adrenal gland function 3. LHRH stimulation test luteinizing hormone-releasing hormone is given to test pituitary gland function 4. TRH stimulation test thyroid-releasing hormone is given to test pituitary and thyroid gland function 5. GHRH stimulation test growth hormone releasing hormone is given to measure growth hormone levels. An oral glucose tolerance test, which is similar to the stimulation tests, may also be done to measure blood glucose (sugar) and insulin levels after drinking a sugary liquid. Healthy volunteers and patients with a hereditary endocrine disorder and their family members may also be asked to provide a blood sample for genetic studies of inherited endocrine disorders. Patients with endocrine-related disorders may be offered medical or surgical treatment for their disorder. AcAccess http://turners.nichd.nih.gov/ for additional study publications.
NCT00001673
This protocol has three purposes: (1) to evaluate subjects for inclusion or exclusion from other NIAAA protocols; (2) to provide a common set of descriptive information that will be available on all NIAAA research subjects; (3) to allow NIAAA medical and nursing staff to treat alcoholic patients for acute alcohol intoxication or alcohol withdrawal before requiring patients to consent to evaluation for participation in research studies. Information collected will include such items as psychiatric diagnoses, presence or absence of brain, liver or other organ damage, history of the amount of past alcohol consumption, other substance use and family history of alcoholism. This information will allow investigators to determine for which, if any, NIAAA research studies a subject is eligible. In order to avoid requiring intoxicated subjects to consent for procedures such as HIV testing, psychiatric interviews, and Magnetic Resonance Imaging (MRI) of the brain we will obtain consent from all alcoholic subjects in two phases, using two separate consent forms. The first consent form will express the subject's desire to be admitted to the NIAAA inpatient unit for the purpose of treatment for alcoholism and will authorize only medical evaluation and treatment for alcoholism and associated problems. After an alcoholic subject has been admitted to the inpatient unit and is judged to be no longer intoxicated or suffering from acute alcohol withdrawal he or she will be presented with the second consent which will describe the evaluation for participation in other NIAAA research studies. Non-alcoholic, healthy controls will sign only one consent form describing the data to be collected and evaluation for participation in other NIAAA research studies.
NCT01411410
This open label Phase 1 study involves treating subjects with advanced cancer with BAY80-6946 in combination with paclitaxel. It will determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of BAY80-6946 in combination with paclitaxel. The trial will involve multiple participating sites from the US. Following determination of the MTD, an expansion cohort of 20 evaluable subjects with breast cancer was planned. Finally, 16 patients have been enrolled to treatment (Cohort 3). A new expansion cohort with modified dosing cohort is now introduced (Cohort 4: breast cancer expansion cohort with modified dosing) in which another 20 subjects are planned to be enrolled to treatment.
NCT00586066
The purpose of this study is to see whether memantine improves memory function in participants with bipolar disorder who have minimal symptoms. Secondary analyses will test the role of memantine in improving residual mood symptoms (depression and mania) in participants with bipolar disorder. We hypothesize that in participants with bipolar disorder who have minimal symptoms memantine will be effective in improving cognitive functions, as measured by the difference in neuropsychological test scores at the beginning and at the end of the trial.
NCT02537028
The primary purpose of this Phase 1b double-blind, randomized, placebo-controlled trial is to evaluate the safety, tolerability, pharmacokinetic (PK), and biological effect of MSC2364447C administered for 4 weeks in systemic lupus erythematosus subjects (SLE).
