Maryland Paid Clinical Trials

Background: - The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health needs healthy volunteers for vaccine clinical trials. This is a screening study that is used to identify healthy volunteers who may be eligible to participate in other clinical trials at the Vaccine Research Center that evaluate investigational vaccines, monoclonal antibodies, and injection devices. The VRC conducts studies that will allow researchers to better understand the immune system and how vaccines and monoclonal antibodies work. Objectives: - To screen healthy volunteers for clinical trials at the NIAID VRC. Eligibility: - Healthy people between 18 and 60 years of age. They must be available to take part in clinical trials and be able to provide blood for research studies. Design: * Screening for healthy volunteers to participate in clinical trials is an ongoing process. * Volunteers will be asked about their medical history, including sexual activity and drug use, and a detailed physical exam will be performed. * Blood and urine samples may be collected, and possibly other tests as needed to evaluate the volunteer's health status. * Volunteers will not receive any investigational product in this screening protocol. Read Less

Background: - Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in using the data collected as part of routine standard epilepsy care to better understand epilepsy and its treatment. Objectives: - To use surgery as a treatment for drug resistant epilepsy in children and adults. Eligibility: - Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy. Design: * Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study. * Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach. * Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period. * Electrodes placed directly in the brain or on the surface of the brain to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus). * Participants will have a surgical procedure at the site of their seizure focus. Brain lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality will be either removed or treated in a way that will stop or help prevent the spread of seizures without affecting irreplaceable brain functions, such as the ability to speak, understand, move, feel, or see. * Participants will return for outpatient visits and brain imaging studies 2 months, 1 year, and 2 years after surgery. Read Less

Background: - Magnetic resonance imaging (MRI) is a widely used scanning technique to obtain images of the human body and evaluate activity in the brain. A particular MRI method called magnetic resonance spectroscopy (MRS) can be used to study brain chemistry as well, which may help researchers who are studying new treatments for psychiatric illnesses. Researchers are interested in improving current MRI and MRS techniques, as well as developing new MRI and MRS techniques to view and measure brain chemicals and brain activity. Objectives: - To implement, develop, and optimize brain chemistry imaging techniques using magnetic resonance imaging and magnetic resonance spectroscopy. Eligibility: - Healthy individuals between 18 and 65 years of age. Design: * This study will involve a screening visit and a scanning visit at the National Institutes of Health Clinical Center. * Participants will be screened with a full medical and physical examination, blood and urine tests, and neurological testing. * During the second visit, participants will have an MRI scan of the brain. (Participants who have received an MRI within the past year will not need to have a second one; the images of the previous scan will be used for this study.) All participants will then have an MRS scan using the same scanning equipment. Read Less

Background: - Gene therapy is being investigated as a possible treatment for individuals with immunodeficiency diseases or other conditions that make it difficult to fight off infection. Gene therapy avoids problems with donor identification and possible rejection of bone marrow transplant by using the patient s own modified blood cells to help treat the disease. Researchers are interested in collecting stem cells from the blood of individuals with immunodeficiency diseases in order to use the cells to develop potential gene therapy treatments. Objectives: - To collect blood stem cells from patients with immunodeficiency diseases tto test our ability to correct the defects of these cells in the test tube. Eligibility: * Individuals between 18 and 40 years of age with immunodeficiency diseases. * Individuals with human immunodeficiency virus (HIV) will not be able to participate in this study. Design: * Participants will provide an initial blood sample for disease screening (such as hepatitis B and C, syphilis, or viruses like the Epstein-Barr virus, herpes simplex virus, or toxoplasmosis) and to check kidney and liver function. * Starting 5 days before blood donation, participants will receive daily injections of a drug called G-CSF (granulocyte colony stimulating factor, or filgrastim), which pushes stem cells out of the bone marrow and into the bloodstream. Participants will receive the injections at the National Institutes of Health Clinical Center. * On day 5, participants will have a single leukapheresis procedure to collect the stem cells from the blood. * No additional treatment will be provided as part of this protocol. The cells that are collected will be used fore experiments in the lab and will not be used to treat individuals with these diseases. Read Less

Background: - Magnetic resonance imaging (MRI) scans must be performed according to specified sets of parameters that provide optimal images of each organ and each area of the body. These scanning parameters are often specific to the institution or organization at which they are employed, and may also depend on the manufacturer of the MRI scanning equipment. Because MRI scanning equipment is always being updated and upgraded, researchers are interested in developing new and optimized scanning parameters for MRI scans. Objectives: - To improve current methods and develop new techniques for magnetic resonance imaging. Eligibility: * Individuals 18 years of age and older who are either volunteers or current NIH protocol participants. * Participants must not have any medical history factors (e.g., extreme claustrophobia, history of metal implants) that would prevent them from receiving MRI scans. Design: * Participants will have at least one MRI scan that will last from 20 minutes to 2 hours (most scans will last between 45 and 90 minutes). The total time commitment for most visits will be approximately 4 hours from start to finish. * Some MRI techniques require standard monitoring equipment or specific procedures during the scanning, such as an electrocardiogram. * Participants will have blood samples taken at the time of the scan. Some MRI studies will require the use of a contrast agent that will be administered during the scan. * Volunteers may be asked to return for additional MRI scans over the course of a few years. Follow-up scans may be done on the same part of the body or on different parts of the body. No more than one MRI scan will be performed in any 4-week period for this protocol. Read Less

Background: - Researchers are studying types of thyroid cancer that seem to cluster in families. Non-medullary thyroid cancer accounts for the vast majority of all types of thyroid cancer, but little is known about possible genes that may cause the cancer. More research is needed to develop the best ways to screen for familial non-medullary thyroid cancer (FNMTC) so that it can be diagnosed and treated at an early stage. Objectives: * To evaluate the natural history of FNMTC. * To determine the best screening strategy for FNMTC. * To identify genes that may indicate susceptibility to FNMTC. Eligibility: - Individuals at least 7 years of age who have two first-degree relatives (e.g., parents, children, siblings) who have or have had non-medullary thyroid cancer or a documented diagnosis of non-medullary thyroid cancer and one living relative with documented non-medullary thyroid cancer. Design: * Participants will be evaluated by family history pedigree, physical examination, imaging (including possible neck ultrasound and radioactive iodine scans), and laboratory testing. * Participants who agree to have blood or other biological samples collected will be asked to enroll in an additional study to provide the appropriate samples and tissues. * After the initial study evaluation, participants who are not found to have a malignant thyroid tumor will be re-screened every year with non-invasive imaging studies. Participants who are found to have a malignant thyroid tumor will be informed of possible treatment options. Read Less

Background: * Drugs of abuse have effects on mood, behavior, thinking, and decision making that may encourage people to continue using them and make it difficult for them to stop. Researchers who study these effects are interested in developing new tests to evaluate how drugs and drug use affect different areas of the brain. * Magnetic resonance imaging (MRI) scans allow researchers to study brain activity and changes to brain function. When specific psychological tests are performed during functional MRI (fMRI) scans, researchers can examine the effects of drug use on the brain. By developing and testing new procedures for fMRI studies, more information can be obtained on brain function and activity in drug-using and non-drug-using individuals, and this information can help develop new treatments and therapies for substance abuse. Objectives: - To develop, assess and refine of cognitive and affective tasks and determination of their practical feasibility and efficacy for both MRI and non-MRI application. Eligibility: * Healthy volunteers between 18 and 65 years of age who are willing to undergo MRI scanning. * Both drug-using and non-drug-using individuals will be selected for this study. Design: * Before the start of the study, participants may complete as assessment of medical and psychological history, and provide information about past or current drug use. Researchers will introduce the tasks to be performed and may have participants practice the tasks. * During the study, participants will be asked to do one or more tasks selected by the researchers. The tasks may be performed on a computer in an MRI machine, and may involve receiving rewards (such as money or sips of juice) for actions, memory and reaction-time tests, or other tests that involve responding to instructions on the screen. * Participants will receive compensation for their participation in the study, including hourly compensation for individual visits.... Read Less

This study will evaluate members in families with a history of small bowel carcinoid cancer to study the natural history of those family members that have the disease, determine ways to improve early detection by performing surveillance on those at risk but without disease and to identify the gene(s) that may cause the tumors. Familial carcinoid tumors usually originate in hormone-producing cells that line the small intestine or other cells of the digestive tract. The tumors are slow-growing and usually take many years before they cause symptoms. It is known that these tumors occur more often in some families and are then passed from one generation to the next by inherited genes. Members of families, including all siblings and offspring in which two or more immediate blood relatives have had small bowel carcinoid tumors are eligible for this study. In some cases unaffected spouses of family members diagnosed with carcinoid cancer are also requested to participate by donating a sample of blood only. Participants undergo a medical evaluation every 3 years during a 3- to 5-day hospital stay at the NIH Clinical Center. All participants have a personal and family medical history obtained and undergo a physical examination, blood and urine tests. People who already have a small bowel carcinoid tumor or are at risk of developing a carcinoid tumor have some or all of the following procedures to determine the presence of carcinoid tumor and its (omit next two words- location or) spread to other areas of the body: * Video Capsule Endoscopy: Visualization of the gastrointestinal tract by ingesting a disposable, "vitamin-pill sized" video capsule that has its own camera and light source. * CT of the chest abdomen and pelvis with oral and IV contrast : X-ray examination of the chest, abdominal and pelvis organs. * 18 FDOPA Positron emission tomography (PET) with CT for localization: Nuclear imaging scan to look at tumor activity. * MRI Liver with contrast - to determine if disease has spread to liver * Gallium 68 PET/CT-limited to individuals that have residual tumor. * Clinical and research blood work Should mid gut carcinoid tumors be found every participant will be assisted in determine what the best course of treatment will be for them. ... Read Less

This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body. The purpose of the study is to collect a variety of blood samples that may then be used to investigate advances and potential new drug treatments for sickle cell disease. Volunteers must be at least 18 years of old. Samples will be taken both from healthy volunteers and from volunteers who have unique red blood cell features that are related to sickle cell disease. Candidates will be screened with a medical history. During the study, participants will undergo a one- to two-hour outpatient procedure at the National Institutes of Health Clinical Center. Once researchers have explained the study and obtained the participant s consent, participants will donate 8 cc (approximately 2 teaspoons) of blood. Because repeat testing helps researchers validate study findings, participants who have the unique red blood cell features mentioned above may also be asked if they are willing to return and donate another 2 cc to 8 cc of blood for additional studies. The amount of blood drawn will not exceed 50 ml with any eight-week period for adults or 7 cc within any six-week period for children. Read Less

This study will describe the phenotype (physical and behavioral traits) of overweight and obese people. It will characterize the hormones, metabolism, food preferences, fitness and physical activity levels, sleep patterns and thought processes in people with and without weight problems. Genetic material will be collected for studies of the internal codes that influence body weight. People over 18 years of age from all weight categories (lean, overweight, obese) who are reasonably healthy may be eligible for this study. Participants undergo the following tests and procedures: * Physical exam, electrocardiogram, blood and urine tests, instructions for recording food intake for 7 days * Metabolic studies for menstruating women. * Resting metabolic rate to study how many calories the body burns at rest. * Mixed meal test to measure hormones such as insulin that regulate blood sugar. * Glucose tolerance test to determine how sensitive the body is to insulin. * 24-hour energy expenditure to measure the amount of oxygen breathed in and the amount of carbon dioxide breathed out. * Repeat 24-hour energy expenditure. * Diurnal blood sampling and temperature assessment to study the body s internal clock. * Air-displacement plethysmography (Bod Pod) to measure body composition. * Dual energy x-ray absortiometry (DEXA) to measure body fat and bone density. * Repeat Bod Pod and DEXA. * Anthropometric measurements and bioelectrical impedance to measure height, weight, and circumferences, skinfold thickness, fluid status and percentage body fat. * Bromide dilution to measure the amount of water not in cells in the body. * Doubly labeled water to measure the amount of calories burned in a 7-day period. * 24-hour diet reports. * Endothelial reactivity to measure how the blood vessels stretch or dilate for assessing cardiovascular health. * Treadmill or bicycle exercise capacity test. * Physical activity monitor. * Unicorder to detect any breathing difficulties that may interfere with sleep. * Fat and muscle biopsy to look for variations in gene expression in fat tissue and muscle. * Neurocognitive testing to check memory, decision-making, hand-eye coordination, and reasoning. * Evaluation of mood problems and assess personality type. * Evaluation to assess the quantity and quality of pain experienced. * Taste testing to determine the response to bitter, salty, sweet and sour substances. * Occupational therapy evaluation to explore the subject s adaptations, if any, for performing personal, social or professional activities; the subject s views on his or her weight, body size and shape, and strategies to control weight. Read Less

Researchers intend on diagnosing and treating certain inborn errors of metabolism. By doing this researchers hope to expand their knowledge about these disorders and provide access to patients of interest for research, teaching, and clinical experience. Patients participating in this study will be examined and treated on an out patient basis, if practical. However, patients requiring specialized tests or treatments will be admitted to the NIH Clinical Center as necessary. Researchers will use only accepted medical procedures in diagnosing (medical history, physical examinations, X-ray studies, eye examinations, blood tests, and urine tests) and treating the patients involved in this study. Additional tests may be required on a case to case basis. Many patients seen in this study will go on to be enrolled in a specific disease-related research study.\<TAB\> Read Less

This study will evaluate and gather information in patients with genetic causes of too much androgen (male-like hormone) in order to better understand the effects of too much androgen and describe problems associated with it. Too much androgen in childhood, if untreated, results in rapid growth and early puberty with early cessation of growth and short stature in adulthood. Too much androgen in adulthood may result in infertility, and women may have excess facial hair, acne and a more male-like appearance. Excess androgen may also affect mood and behavior and possibly the secretion of other hormones, such as insulin. Two genetic diseases that result in early childhood androgen excess are congenital adrenal hyperplasia (CAH) and familial male-limited precocious puberty (FMPP). Patients with known or suspected CAH due to 21-hydroxylase deficiency, 11- hydroxylase deficiency, or 3-beta-hydroxysteroid dehydrogenase deficiency and males with known or suspected FMPP may be eligible for this study. Patients with both classic and non-classic CAH are eligible, and patients with androgen excess of unknown cause may be eligible. Participants undergo the following procedures: * Medical history and physical examination. * Fasting blood tests for analysis of hormones, blood chemistries including blood sugar and cardiovascular risk factors such as lipids. * Oral glucose tolerance test for patients with elevated insulin levels. For this test, a catheter (plastic tube) is placed in a vein in the patient's arm. The patient drinks a sugar-containing fluid and blood samples are collected through the catheter at intervals starting with drinking the solution, and then 30, 60 and 120 minutes after drinking the solution. * 24-hour urine collection to measure hormone levels in the urine. * DNA testing for patients with 21-hydroxylase deficiency to help identify the type of genetic mutation responsible for the disease. * X-ray of the left hand to measure bone age in growing children. The x-ray is used to determine how far into puberty the child is and how much growth potential is left in the bones. * A pelvic ultrasound in females and testicular ultrasound in males to evaluate the size and development of the gonads (ovaries in females and testes in males). * Cognitive and psychological tests, including an IQ test and evaluation of memory, achievement and behavior. * Other tests and evaluations based on medical need. The schedule for these procedures varies. In a part of the study involving only patients with CAH, growing children are evaluated twice (once in childhood and once after reaching adult height), and adults are evaluated once. In another part of the study involving patients with CAH and FMPP, growing children are seen twice a year, and adults and children who have reached adult height may be seen annually. Additional visits may be scheduled if medically indicated. In this part of the study, females are asked to keep a record of their periods after their first menstrual cycle. Read Less