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Healthy Volunteers clinical trials

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NCT ID: NCT00546091 Completed - Clinical trials for Healthy Volunteers Only

Calibrating Imaging Techniques to Study Blood Flow

Start date: October 15, 2007
Phase: N/A
Study type: Observational

This study will explore the uses of three noninvasive imaging techniques-thermography, laser Doppler imaging, and multispectral imaging-to test the blood flow of healthy volunteers. By comparing these three techniques, researchers will be able to train these imaging systems to better evaluate skin types and blood flow. The study will also test computer programs that have been developed to correct for the effects of curvature and body hair on the images. Healthy volunteers must be older than 18 years of age and may not have had a history of malignant tumors, skin disease, or vascular disease. Participants will undergo the following procedures on an outpatient basis: Three different types of images taken of the participant s forearm - Thermography infrared thermal imaging to map skin temperature - Laser Doppler imaging low-powered laser imaging to map blood flow in the skin - Multispectral imaging near-infrared light imaging to measure total blood flow and oxygen levels in the skin A reactive hyperemia experiment, in which multispectral images will be taken of the participant s forearm during and after the use of a blood pressure cuff A hair removal experiment, in which images will be collected of the participant s forearm in separate scans done before and after the hair is removed with a topical hair removal solution The entire series of exams will take approximately one hour to perform.

NCT ID: NCT00543647 Completed - Healthy Volunteers Clinical Trials

Effect of Fenofibrate on Kidney Function: a Six-week Randomized Cross-over Trial in Healthy People

Start date: August 2002
Phase: Phase 1
Study type: Interventional

The purpose of this study was to test the effect of fenofibrate treatment on glomerular filtration rate (GFR), kidney hemodynamics and tubular function in middle-aged subjects with normal kidney function to further investigate the increase in creatinine levels observed in fenofibrate-treated subjects.

NCT ID: NCT00520273 Completed - Healthy Volunteer Clinical Trials

A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA

Start date: August 2007
Phase: N/A
Study type: Interventional

This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor samples in 96-unit pools.

NCT ID: NCT00517855 Completed - Healthy Volunteers Clinical Trials

Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult Volunteers

Start date: June 2007
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT00479921 Completed - Healthy Volunteers Clinical Trials

Annual Study to Investigate Influenza Vaccine Due to New Virus Strains for the 2007/2008 Influenza Season in Europe

Start date: June 2007
Phase: Phase 3
Study type: Interventional

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).

NCT ID: NCT00474201 Completed - Healthy Volunteers Clinical Trials

Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil

GEM-PK
Start date: May 2007
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00446771 Completed - Healthy Volunteers Clinical Trials

A Pharmacokinetic and Bioavailability Study of Mannitol for Inhalation Using Normal Subjects

Start date: October 2006
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT00441077 Completed - Healthy Volunteers Clinical Trials

Interventions to Educate An Underserved Population About Inherited Disease Risks

Start date: February 19, 2007
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00426465 Completed - Healthy Volunteer Clinical Trials

Spaced Versus Massed Skill Learning

Start date: January 17, 2007
Phase:
Study type: Observational

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.

NCT ID: NCT00390988 Completed - Healthy Volunteers Clinical Trials

Capillary and Venous Blood Count Parameters

Start date: n/a
Phase: N/A
Study type: Observational

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.