View clinical trials related to Healthy Volunteers.
Filter by:This study is the second human clinical study with PRTX-100. It is designed to assess the safety of a single intravenous (IV) dose of PRTX-100, as well as, how the drug is eliminated from the blood after dosing. Additionally, this study provides an opportunity to monitor immune system response to PRTX-100.
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).
This study will determine whether the protease inhibitor lopinavir/ ritonavir (Kaletra (Trademark)), which is used to treat HIV disease, lowers blood levels of the lipid-regulating drug gemfibrozil (Lopid (Trademark)) in HIV-negative healthy volunteers. Many patients with HIV infection who take protease inhibitors have abnormally high lipids (cholesterol and triglycerides). Gemfibrozil, commonly used to treat high triglycerides, often is not effective in HIV-infected patients taking protease inhibitors, possibly because of an interaction between the two medicines that causes a lowering of gemfibrozil's levels in the blood. Results from this study will give researchers information on whether lopinavir/ ritonavir affects the blood levels of gemfibrozil. Healthy, normal volunteers between 18 and 65 years old who test negative for HIV may be eligible for this study. On study day 1, subjects have a blood sample drawn from a catheter inserted into a vein in the arm to determine pre-dosing blood levels of gemfibrozil. They then take a gemfibrozil tablet and are given breakfast 30 minutes after taking the drug. Blood samples are obtained through the catheter at 0, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours after dosing to determine gemfibrozil levels at those intervals. At the end of 12 hours, the catheter is removed and the subject is discharged from the clinic. The next morning subjects return to the clinic for another blood sample, collected through a vein in the arm. Subjects begin taking lopinavir/ ritonavir between 7 and 35 days after their first dose, depending on their schedule and the clinic schedule. On the fourteenth day of dosing subjects come to the clinic and are given a single dose of gemfibrozil, as on study day 1, and have breakfast 30 minutes later. Blood samples are collected to determine gemfibrozil levels just like on study days 1 and 2. An additional sample is collected for routine lab tests.
The study has an open-label, randomized, crossover design, in which each subject will receive mannitol powder for inhalation using a dry powder inhaler with and without premedication with a bronchodilator, mannitol powder for inhalation in capsules administered orally, and mannitol in a commercial formulation designed for intravenous use.
The Hematology Branch of the National Heart, Lung, and Blood Institute is doing a variety of laboratory research experiments that require blood and tissue samples from healthy volunteers. This protocol provides a mechanism for collecting these tissue samples. Research includes studies of normal and abnormal formation of blood cells, viral blood diseases, the role of the immune system in marrow failure and genetic risk factors for aplastic anemia. Healthy normal volunteers 8 years of age and older may be eligible for this study. Samples are collected as follows: - Blood samples: Participants 8 years of age and older donate up to 4 tablespoons of blood, which is obtained from a needle placed in an arm vein. - Participants 8 years of age and older donate a buccal mucosa sample (cells from the inside of the cheek). The inside of the cheek is scraped gently with a nylon brush. - Participants 18 years of age and older donate a bone marrow sample. The bone marrow is obtained from the hip bone. The skin over the area is wiped clean with alcohol and iodine, and then a local anesthetic is injected under the skin and also into the bone. When the area is numb, a bone marrow aspiration needle is introduced through the bone surface into the marrow. The marrow cells are collected using a syringe connected to the needle.
This study will examine how to communicate with an underserved population about inherited disease risks. It will present information about inherited risk to a Latino population through either a lay health advisor (LHA) or through printed information. The LHA is a member of the Latino community who has received training in public speaking, group facilitation, and managing group dynamics and in family health history and genetics. Previous studies have shown that an LHA can effectively communicate health information to diverse audiences, but such interventions have not been studied in the context of inherited risk. Spanish-speaking Latino men and women over the age of 18 in the Oakland, CA, and Washington, DC, areas who have basic Spanish reading and writing skills may be eligible for this study. Participants are recruited to one of two groups. One group participates in group educational sessions with an LHA about inherited disease risks and family health history, and the other receives this information from a brochure. Educational Sessions Groups of 5 to 8 individuals complete a questionnaire and then participate in a 45-minute educational session on concepts related to genetics, family health history, lifestyle and environment. Participants engage in role-playing to practice discussing family health history with family members. The LHA teaches participants the skills needed to fill in family health history tool called My Family Health Portrait and answers questions. After the question and answer session, participants complete a second questionnaire. Brochure-Only Participants complete a questionnaire and then read a Spanish-language brochure produced by the U.S. Surgeon General's Office about the importance of knowing one's family history. They then complete a second questionnaire.
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.
This study will explore the optimum training schedule for stroke patients to learn motor skills. It will see if motor training is more effective when training sessions are distributed over time (spaced training) or when the sessions are scheduled close together (massed training). The results of this study may help researchers devise the best training schedule for patients to derive the maximum benefit from rehabilitation therapy. Healthy normal volunteers and people who have had a stroke may be eligible for this study. Patients must be 3 months post-stroke. All participants must be right-handed and between 18 and 80 years of age. Participants practice a pinch motor task and receive transcranial magnetic stimulation (TMS). Hand muscle activity is measured using surface electromyography (EMG). Pinch training involves training the participant to pinch as strongly as possible, using a device that records the force. For TMS, a wire coil is held on the subject s scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. For surface EMG, electrodes (small metal disks) are filled with a conductive gel and taped to the skin over the muscle. Following one practice session of pinch task training and TMS, participants have four training sessions, which are scheduled 24 hours, 2 weeks, 1 month and 3 months after the practice session. For the 4- to 5-hour practice session, subjects do the following: - Perform a single session of pinch motor task for familiarization - Undergo TMS to measure brain activity - Practice five 6-minute blocks of pinch motor task with rest periods between sessions and perform a calculation task (addition and subtraction tasks) during each rest period - Receive TMS over 15 minutes. (Some sessions may have sham TMS.) - Read books and magazines during a 45-minute rest period - Perform a single block of the pinch motor task - Undergo TMS to measure brain activity - Complete a questionnaire that measures attention, fatigue and mood For the remaining four sessions, participants perform one practice block and TMS. Each session lasts about 2 hours.
This study will examine genome sequencing in clinical research. Genome sequencing is a process in which researchers analyze (or sequence) part or all of the genome from a single person. The human genome is the material in cells that includes thousands of genes. Gene changes that cause or contribute to disease can be passed on from one generation to the next. This study first focuses on heart disease. Later, researchers hope to study other conditions and genes, with the eventual goal of sequencing most or all of participants genes. Participants ages 45 to 65 years of age and who do not smoke, may be eligible for this study. Patients will come to the NIH Clinical Research Center for an initial study to last about half a day. They will donate a blood sample and complete a short survey. Then they will meet the genetic counselor to learn more about genome sequencing. Those who join the study will undergo the following procedures and evaluations: - Family history and medical history. - Measurement of height and blood pressure. - Noninvasive heart tests, including electrocardiogram and echocardiogram. - Drawing of about 3 ounces of blood (5 to 6 tablespoons); part of the blood sample will be used for research and another part for clinical testing. - Multidetector computed tomography (CT), a test to measure coronary artery calcification, that is, condition of inflexibility. Each patient will receive a letter with results of the clinical laboratory values and evaluations. There will be recommendations for follow-up with the patient s doctors. Risks in this study include exposure to radiation from the CT test. The radiation amount used is about the same that a person normally receives from natural sources, such as from the sun, outer space, and radioactive materials found naturally in the earth s air and soil. Another slight risk involves reactions to a contrast agent that may be used in the echocardiogram. Side effects can be headache, nausea or vomiting, a warm sensation, and dizziness. With the samples that patients provide, researchers will start by sequencing about 400 genes related to heart disease. Analysis will take months to complete. Genome sequencing is difficult to do, and researchers have much to learn about the genes they sequence and the gene changes they find. If the researchers find gene changes that are important to the health of a participant, they will contact that participant and give him/her the choice of learning such results. This study may or may not have a direct benefit for participants. Patients would get free clinical testing for cholesterol, diabetes, and other conditions, as well as information about gene changes. Knowledge gained will benefit people in the future as researchers learn about the relationship between gene changes and health.
The purpose of this study is to compare capillary blood count parameters with the corresponding venous samples to verify the hypothesis that capillary and venous blood count parameters are equivalent.