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5181. Familial Aggregation of Barrett's Esophagus

. Following sample collection the textured balloon is inverted back into the hollow capsule component via syringe draw vacuum in order to maximize & protect the site-specific sample collection. Other Name: Esophageal Sampling Device BESD-001 Procedure: Endoscopy An upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube. Other Name: EGD EGD Screening Patients scheduled for clinically indicated EGD for GERD who meet ACG (...) -specific sample collection. Other Name: Esophageal Sampling Device BESD-001 Procedure: Endoscopy An upper endoscopy is a procedure used to visually examine your upper digestive system with a tiny camera on the end of a long, flexible tube. Other Name: EGD Outcome Measures Go to Primary Outcome Measures : Assay of DNA and RNA markers [ Time Frame: 1 week ] The Balloon tip is collected and sent to the University Hospitals Translation Laboratory to test for DNA extraction Secondary Outcome Measures

2003 Clinical Trials

5182. Single Photon Emission Computed Tomography to Study Receptors in Parkinson's Disease

the scan, the day of the scan, and for 4 days after the scan, subjects take an oral dose of potassium iodide to protect the thyroid gland from the radioactive tracer used in the SPECT procedure. (People allergic to potassium iodide will take potassium perchlorate instead.) Before the scan, small radioactive markers containing 99Tc are glued to the subject's head. Two catheters (thin, flexible tubes) are placed in veins in the arms to inject the radioactive tracer [123I]5-I-A-85380 and to draw blood (...) samples. Another catheter is placed in an artery in the wrist to draw arterial blood samples. During the scan, the subject lies on a bed with his or her head held still with a head holder. The scans are taken over a 6-hour period after injection of [123I]5-I-A-85380. An electrocardiogram, respiration, and blood pressure measures are taken before the tracer is injected, then 5 minutes after the injection, and again 30 to 60 minutes after the injection. Blood and urine samples are collected 5 to 6 hours

2003 Clinical Trials

5183. Peptide Vaccination for Patients at High Risk for Recurrent Melanoma

as long as the melanoma does not return. The injections are given at the National Institutes of Health (NIH) Clinical Center. Patients are monitored for 1 hour after each injection and have blood tests and a physical examination to look for treatment side effects. Patients will be followed with blood tests every 12 weeks to monitor body functions. They will also undergo leukapheresis-a procedure to collect white blood cells-before starting treatment and about 3 to 4 weeks after the fourth vaccine (...) metastatic melanoma, within 6 months of surgical resection will be considered. Patients must be clinically disease free at the time of protocol entry as documented by radiologic studies within 6 weeks of patient entry. Serum creatinine of 2.0 mg/dl or less. Total bilirubin 1.6 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl. White blood cell (WBC) 3000/mm^3 or greater. Platelet count 90,000 mm^3 or greater. Serum aspartate aminotransferase

2003 Clinical Trials

5184. High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple Sclerosis

patients will also have an MRI (where pictures are created using magnetic rather than x-ray energy) of the brain and other evaluations that are standard for any patient before having a transplant. Before the transplant patients will receive daily G-CSF (Neupogen). This medicine will help to stimulate the production of white blood cells (WBC) that will be used for the bone marrow transplant. In addition, 6 tablespoons of blood will be collected to look at how the immune system is functioning before (...) and after transplant. After the white blood cells have reached a certain level, patients will undergo leukapheresis. Leukapheresis is a procedure where blood is removed from a patients arm, pumped into a machine where the white blood cells are separated from most of the other cells, then returned to the patient through the same needle or through a needle in the other arm. After collection of the white blood cells, we will use a device in the lab to select out certain types of white blood cells (CD34

2002 Clinical Trials

5185. Tenofovir Disoproxil Fumarate to Treat Pediatric HIV

, patients will begin taking tenofovir DF. For the first 2 days on the drug, a small blood sample (1/2 teaspoon) will be collected 11 times over a 48-hour period through. A heparin lock (a tube kept in place in a vein) may be put in place to avoid multiple needle sticks. Blood samples will be collected for another 4 days to measure how well tenofovir DF alone works against HIV before other drugs are added to the treatment regimen. After these first 6 days, at least two other anti-HIV drugs will be added (...) and neuropsychiatric examinations, blood tests, including tests to determine what anti-HIV drugs the patient is resistant to, an echocardiogram (echo), electrocardiogram (EKG), chest X-ray, head CT scan, skin tests, and special tests to examine the bones. These physical exams and tests will be repeated throughout the study to determine changes in health. Participants will continue their current anti-HIV therapy for 2 weeks and then stop all medicines for a 1-week 'washout' period. After the washout period

2001 Clinical Trials

5186. Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging

breathing into a machine that measures the amount of air inhaled and exhaled. Upon reporting to the GCRC on day 2, the patient will be taken for a BAL (the patient will have fasted for at least 6 hours prior to admission). BAL involves a small tube placed into the mouth, down the throat, and into the lung (lidocaine is used to numb the entire area). Less than 3 tablespoons of saline (salt water) is poured down the tube, then immediately sucked back up and collected by the doctor. This is repeated twice (...) and the number of neutrophils obtained from the BAL. This study will also look at how the PET images relate to inflammatory molecules in the lungs and to the FEV-1 obtained through spirometry. Condition or disease Intervention/treatment Cystic Fibrosis Procedure: FDG-PET Procedure: spirometry Procedure: bronchoscopy with BAL Detailed Description: All patients involved in the study will have a PET scan performed. This involves injecting a small amount of radiolabelled glucose (sugar) into the blood. A scan

2001 Clinical Trials

5187. Simvastatin Therapy in Smith-Lemli-Opitz Syndrome

the CSF circulates below the spinal cord. A small amount of fluid is collected through the needle. CRH stimulation test to detect hormone-related problems in cholesterol synthesis. The patient is given CRH, a hormone involved in cholesterol synthesis, through a plastic tube placed in a vein. Blood samples are collected through the same catheter to measure levels of other hormones involved in cholesterol production. Electroencephalogram (EEG) to look at the electrical activity (brain waves (...) , and at the Kennedy Krieger Institute in Baltimore, MD, upon admission to the study and again at 6, 12, 20, and 26 months. The visits will last 3 to 4 days, and will include a medical history and physical examination, photographs to document medical findings, and other procedures detailed below. In addition, blood samples will be collected at 1, 3, 9, 14, 15, 17, and 23 months. Parents will complete several questionnaires during the study. Procedures include the following: Simvastatin and cholesterol

2003 Clinical Trials

5188. Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes

arginine, a normal constituent of food that increases insulin release from beta cells into the blood stream. After the injection, seven blood samples are collected over 10 minutes. Mixed meal stimulated C-peptide test with acetaminophen: This test assesses the response of the beta cells to an ordinary meal and the time it takes for food to pass through the stomach. The patient drinks a food supplement and takes acetaminophen (Tylenol). Blood samples are then drawn through a catheter (plastic tube (...) attacks the beta cells of the pancreas. These cells produce insulin, which regulates blood sugar. AC2993 may improve the pancreas's ability to produce insulin and help control blood sugar, but it may also activate the original immune response that caused the diabetes. Thus, this study will examine the effects of AC2993 alone as well as in combination with immunosuppressive drugs. Patients between 18 and 60 years of age who have type I diabetes mellitus may be eligible for this 20-month study

2003 Clinical Trials

5189. Study of Thyrotropin-Releasing Hormone in Normal Volunteers and in Patients With Thyroid or Pituitary Abnormalities

for healthy volunteers and patients. All participants fast from midnight before the morning of the test. In the morning, a catheter (flexible plastic tube) is inserted into an arm vein for easy injection of the TRH and collection of blood samples. Blood pressure is monitored before and during the test. A blood sample is drawn, and then TRH is given through the catheter over a 1-minute period. Another nine blood samples are collected over a 3-hour period from the time of the TRH injection for measuring (...) of hypothalamic-pituitary-thyroid gland interaction may be eligible for this study. Patients include those with pituitary reserve, inconsistent thyroid function test, inappropriate TSH secretion, or pre- and post-operative evaluation of pituitary tumors. Normal volunteers will be screened with a medical history, physical examination, and blood tests. Women of child-bearing potential will be given a pregnancy test; pregnant and breast-feeding women may not participate. The TRH test procedure will be the same

2003 Clinical Trials

5190. A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat

of antibiotic used in this study Tubes in place in the affected ear to allow drainage of fluid from the middle ear Requirement of antibiotic therapy that affects the whole body, other than the study drug A serious bacterial infection in addition to middle ear infection that may interfere with assessment of the patient's response to study medication Diagnosis of bacterial meningitis Abnormal kidney function, as determined by blood test (serum creatinine) History or presence of joint disease or disease (...) ; a 4 to 6-day treatment, blood collection, possible collection of fluid from the middle ear, and assessment period; and a post-treatment period to assess the status of the middle ear infection. All patients will receive levofloxacin 2 times daily (up to a maximum daily dose of 500 mg) mixed with liquid and taken by mouth for 10 days. Safety evaluations will include laboratory tests, physical examinations, vital sign measurements, and recording of adverse events, including any report of joint pain

2002 Clinical Trials

5191. Positron Emission Tomography (PET) to Study Brain Signaling

. For this procedure, the subject lies on a table that is moved into a metal cylinder (the scanner) and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. Scanning time varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. Subjects may be asked to lie still for up to 30 minutes at a time. PET For the PET scan, a catheter (thin plastic tube) is inserted into an artery in the subject's wrist or elbow crease to collect blood samples (...) of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study uses positron emission tomography (PET) to examine brain function and signaling involving phospholipids, and to see how signaling is related to blood flow. Much of the brain is composed of fatty molecules called phospholipids. These molecules are involved in the way brain cells signal each other to direct brain function. Brain disease may change phospholipids and disturb brain structure and signaling. Studies

2002 Clinical Trials

5192. Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas

. Then, the cells are collected by apheresis. In this procedure the blood is drawn through a needle placed in one arm and pumped into a machine where the stem cells are separated out and removed. The rest of the blood is returned to the donor through a needle in the other arm. Patients: For patients who do not already have a central venous catheter (plastic tube), one is placed into a major vein. This tube can stay in the body the entire treatment period for giving medications, transfusing blood, , withdrawing (...) for at least 5 years. During the course of the study, patients undergo repeated medical evaluations, including blood tests and radiology studies, to check on the cancer and on any treatment side effects. On four occasions, white blood cells may be collected through apheresis to see if immune responses can be generated against the sarcomas treated in this study. Positron emission tomography (PET) scans may be done on five occasions. This test uses a radioactive material to produce images useful in detecting

2002 Clinical Trials

5193. Intermittent vs. Continuous HAART to Treat Chronic HIV Infection

. Upon entering the study, patients will have blood tests to monitor the amount of virus in the blood, CD4+ T cell count, viral resistance to HAART medications, side effects of the drug, and immune response to HIV in the test tube. They will have clinic visits for a history, physical examination and blood draws every month for 12 months. At that time, depending on T cell counts and viral load, the number of visits may be reduced, but never less frequently than every other month. Patients will also (...) undergo leukapheresis-a procedure for collecting quantities of white blood cells-every 3 to 4 months while on the study. For this procedure, whole blood is collected through a needle in an arm vein (similar to donating blood). The blood is circulated through a cell separator where the white cells are removed, and the rest of the blood (plasma, red cells and platelets) is returned through the same needle or through a second one in the other arm. The collected white cells are used for special studies

2001 Clinical Trials

5194. G-CSF to Treat Crohn's Disease

. For the procedure, patients are given a medication to lessen anxiety and any discomfort. An endoscope-a lighted flexible tube-is inserted into the rectum, allowing examination of the extent of inflammation. The endoscope can also be used to take pictures of the colon and extract tissue samples for testing (biopsy). Leukapheresis is a procedure for collecting quantities of white blood cells. Whole blood is collected through a needle placed in an arm vein and circulated through a machine that separates (...) it into its components. The white cells are removed, and the rest of the blood is returned to the body, either through the same needle used to draw the blood or through another needle placed in the other arm. After the colonoscopy and leukapheresis, patients receive G-CSF injections every day for 29 days. The patient or a caregiver, such as a family member, will be taught to give the injections. Blood samples will be collected on treatment days 4, 8, 11 and 15, and a physical examination and interview

2001 Clinical Trials

5195. Evaluation of New Test Method to Measure Kidney Function

infections, swelling from fluid accumulation, fluid in the abdomen, or burns-may be eligible for this study. Patients will undergo both the standard and the Fast GFR tests, described below, to evaluate the accuracy of the new test. Fast GFR: Two catheters (thin flexible tubes) are placed into two arm veins, one for injecting iothalamate-an agent commonly used in CT scanning and blood vessel imaging-and the other for collecting blood samples. Baseline blood and urine samples are collected and then 0.5 (...) milliliter (ml) iothalamate is injected into a vein. Blood samples are collected at 5, 10, 15, 20, 30, and 45 minutes in adults and at 5, 15, and 45 minutes in children. Urine is collected at 45 minutes. The size of the bladder is measured using ultrasound to determine if the bladder has completely emptied. Standard GFR: Iothalamate (1 ml) is injected under the skin. Blood samples are collected at 60, 90, 120, 180 and 240 minutes. (A heparin lock is used to avoid multiple needle sticks.) Urine

2001 Clinical Trials

5196. Leptin to Treat Severe Insulin Resistance

samples are collected through the IV tube at various intervals during the 1-hour test. Ultrasound of the liver and, if abnormalities are found, possibly liver biopsies. Fasting blood tests - to measure blood count, blood lipids, and various hormones and assess liver function. Resting metabolic rate - to measure the amount of oxygen breathed at rest in order to calculate how many calories are required to maintain resting body functions. Magnetic resonance imaging of the liver and other organs (...) , and of muscle and fat. Pelvic ultrasound in female patient - to detect ovarian cysts. Estimation of body fat - measurements of height, weight, waist, hip size, and skin folds over the arms and abdomen to estimate body fat content. Oral glucose tolerance test - measures blood sugar and insulin levels. The patient drinks a very sweet drink containing glucose (sugar), after which blood samples are collected through an IV tube in an arm vein at various intervals during the 3-hour test. Intravenous glucose

2001 Clinical Trials

5197. Determination of Variances in Exhaled Nitric Oxide Output in Normal Healthy Male Volunteers Consuming High and Low Nitrate/Nitrite Diets

function, nerve signal transmission, inflammation, and dilation of blood vessels and bronchial tubes (tubes that branch out from the trachea into the lungs). Healthy male volunteers age 18 years or older who have not smoked for at least 5 years may be eligible for this study. Candidates will undergo blood and urine tests, breathing tests, and an electrocardiogram. Participants will follow two special diets for 3 days each. One is a low-nitrate and nitrite diet, and the other is a high-nitrate (...) not engage in any heavy exercise during the diet periods, as exercise affects nitric oxide levels. Blood samples of about 4 milliliters, or 1 teaspoon, each will be collected before starting each diet and at the end of each diet to measure blood levels of nitrate and nitrite. Additional blood samples, totaling about 2 tablespoons, will be collected for research. Each day, participants will have a test to measure exhaled nitric oxide levels. This involves blowing air into a mouthpiece attached

2001 Clinical Trials

5198. The Role of Heart Stiff and Weak Atrium on Exercise Capacity in Patients With Hypertrophic Cardiomyopathy

waves from the chambers of the heart produce images showing the heart's thickness and function. Participants will undergo the following tests and procedures over 3 days: Physical examination and echocardiogram. Intravenous cannula insertion: A plastic tube is inserted into an arm vein for collecting blood samples to measure substances that the heart and circulatory system release at rest and during exercise. Impedance cardiography: A small current of electricity is passed across the chest (...) and electrodes similar to those used for an EKG test are placed to measure blood flow in the area of the current. Pulmonary artery catheterization: A catheter (plastic tube) is inserted into a vein either in the arm, under the collarbone, or in the neck and advanced to the right atrium and ventricle. The catheter remains in place during the echocardiogram tilt and bicycle exercise tests (see below). Echocardiogram tilt test: The patient lies flat on a table. After a few minutes, the table is tilted so

2003 Clinical Trials

5199. Kidney Transplantation in Patients With Cystinosis

and procedures: Kidney transplant: Patients undergo kidney transplant surgery under general anesthesia. Central line placement: A large intravenous catheter (plastic tube, or IV line) is placed in a vein in the chest or neck under local anesthesia before the transplant surgery. The line remains in place for some time during the hospitalization to administer immunosuppressive medications, antibiotics, and blood, if needed. The line is also used to collect blood samples. Leukapheresis: This procedure (...) for collecting white blood cells is done before the transplant. The cells are studied to evaluate the patient's immune system. Whole blood is withdrawn through a catheter in an arm vein or through the central line and directed into a machine that separates the blood components by spinning. The white cells are removed and the red cells and plasma are returned to the body. Immunosuppressive medication following transplantation Adults receive thymoglobulin at the time of the transplant and for 3 days after

2003 Clinical Trials

5200. PET Imaging of DHA Metabolism

tubes) are inserted into an arm vein and into a wrist artery. The venous catheter is used for injecting a radioactive substance that will be detected by the scanner, and the arterial catheter is used for collecting blood samples during the scan. For the scan, the subject lies on a bed that slides into the doughnut-shaped scanner. A mask is placed to keep the head still. A transmission scan is done to see how much radiation the skull absorbs. Radioactive water (15O-water) is then injected (...) for analysis. Blood drawing: Blood samples will be collected at the time of the fat biopsy and the PET scan (see below) to measure DHA and indicators that may influence DHA. Diet: 3 days before the fat biopsy and at least 3 days before the PET scan, subjects will consume a diet low in DHA and other omega-3 fats. This no seafood diet prohibits eating fish, shellfish, seaweed, seafood, health food products or supplemental vitamins, and foods containing canola or flaxseed oil. Caffeine-containing beverages

2003 Clinical Trials

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