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Healthy Volunteers clinical trials

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NCT ID: NCT00900913 Completed - Healthy Volunteers Clinical Trials

Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral Nerve Excitability

Start date: January 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine on the receptive field of primary sensory afferents and their influence on the vascular bed. *Trial with medicinal product

NCT ID: NCT00893971 Completed - Healthy Volunteers Clinical Trials

Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects

Start date: May 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety of a single dose of PT003 compared with single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two separate single doses in healthy subjects.

NCT ID: NCT00888563 Completed - Depression Clinical Trials

Fatigue in Healthy Individuals

Start date: April 23, 2009
Phase:
Study type: Observational

Background: - People with many different diseases have symptoms of fatigue, which is a general sense of tiredness; however, the causes are not fully understood. Fatigue symptoms may be related to a person s level of fitness, health, and blood chemistries. - Researchers are studying the potential role of plasma cytokines (signaling molecules) and hypothalamic-pituitary-adrenal (HPA) axis (part of the neuroendocrine system that controls stress) functioning in symptoms of fatigue. Objectives: - To characterize the symptoms of fatigue in healthy individuals. - To collect information on fatigue, pain, depression, stress, sleepiness, and quality of life from healthy adults of all ages. - To compare results obtained from people with various illnesses to better understand possible causes of fatigue that are associated with those diseases. Eligibility: - Physically and mentally healthy volunteers18 years of age or older who can speak and read the English language. - Exclusion criteria include individuals with a disease or condition causing significant fatigue (congestive heart failure, cancer, or sleep disorders), individuals taking medicines that cause fatigue (beta blockers, diuretics, or narcotics), and individuals who have a major psychiatric condition (major depression, anxiety disorder, or schizophrenia). - The following individuals may not participate: those who have two more alcoholic drinks per day, who use illicit drugs, or who drink more than 4 cups of coffee, 8 cups of soda or tea, or similar amounts of other caffeine-containing beverages a day, or eat more than 1 pound of chocolate per day; and individuals who worked evenings or night shifts in the past month. - Women who are pregnant or breastfeeding are not eligible. Design: - Participants must make two outpatient visits to the Clinical Center. Each visit will last 5 hours and participants must refrain from smoking and consuming alcohol and caffeine for at least 24 hours. - During the first study visit, researchers will conduct the following tests: - Psychiatric interview, medical history, pregnancy test, and drug test. - Urine test to measure the levels of stress hormones. - Questionnaires that measure fatigue, pain, depression, stress, daytime sleepiness, and activity. - Physical fitness test, including strength tests, walking tests, and physical activity monitoring. - Before the second study visit, patients must refrain from smoking and consuming caffeine and alcohol for at least 24 hours and have nothing, even water, by mouth after midnight. During the second study visit, the following tests will be conducted: - Stress hormone test (participant will receive a cortisol-releasing hormone). - Four intravenous blood draws to determine cytokine profiles, gene expression, and levels of stress hormones (immune and gentic analysis). - Participants will receive a small financial compensation for participation in the study.

NCT ID: NCT00885040 Terminated - Healthy Volunteer Clinical Trials

Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders

Start date: April 17, 2009
Phase:
Study type: Observational

Background: - Many people can learn to use feedback about brain activity to modify that activity, but is it not known if people with Tourette syndrome can modify their brain activity. - Researchers have evidence that certain areas of the brain are involved in causing tics in people with Tourette syndrome. If people with Tourette syndrome can use feedback about brain activity to modify activity in those parts of the brain, they may be able to modify their brain activity to help control the tics. Objectives: - To determine if people with and without Tourette syndrome can learn to use thought to control brain activity. - To test whether people who have Tourette syndrome can learn to control brain activities, possibly helping to control tics. Eligibility: - Healthy volunteers ages 18 and older who are right-handed and are willing to not consume caffeine or alcohol for 24 hours before the study visit. - Patients with Tourette syndrome who have tics that can be observed and studied. - All participants must be able to undergo magnetic resonance imaging (MRI) scans. Design: - Healthy volunteers (two visits to the NIH Clinical Center over a 2- to 4-week period; visit may last up to 3 hours): - Screening visit, including physical examination and medical history, and a magnetic resonance imaging (MRI) scan if the individual has not had one performed at the National Institutes of Health in the past year. - Study visit: Functional MRI (fMRI) scan to allow researchers to see if volunteers can learn to control their brain activity during a scan. Volunteers will be asked to complete tasks as directed during the fMRI scan. - Patients with Tourette syndrome (three or four outpatient visits over a 4- to 6-week period; each visit may last up to 4 hours): - Screening visit, including physical examination and medical history, and an MRI scan if the individual has not had one performed at the National Institutes of Health in the past year. - Evaluation visit to ask questions about Tourette symptoms and to have patients complete questionnaires about their tics and their mental health. - Study visit: fMRI scan to allow researchers to see if patients can learn to control their brain activity during a scan. Patients will be asked to complete tasks as directed during the fMRI scan. - Final visit: Researchers will ask questions about tic symptoms, have patients complete questionnaires, and perform a brief exam. Afterward, patients will have an fMRI scan similar to the previous one. - All participants will be paid a small amount of money in compensation for their participation in the study.

NCT ID: NCT00883935 Completed - Healthy Volunteer Clinical Trials

GSK1349572 Drug Interaction Study With Atazanavir/Ritonavir and Atazanavir

Start date: April 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the amount of GSK1349572 (study drug) in the blood when given with and without atazanavir/ritonavir or atazanavir and to compare the blood levels of atazanavir when given with GSK1349572 to historical data for atazanavir.

NCT ID: NCT00882804 Completed - Healthy Volunteers Clinical Trials

Hemin in Healthy Subjects

Start date: February 2009
Phase: Phase 1
Study type: Interventional

This study is being done because we want to learn if hemin can increase the production of heme oxygenase 1. Heme oxygenase 1 (HO-1) is an enzyme which protects cells from physical, chemical, and biologic stress. Hemin is produced from red blood cells and is approved by the Food and Drug Administration for treating acute porphyria, which is an inherited condition caused by an enzyme deficiency.

NCT ID: NCT00879983 Completed - Healthy Volunteers Clinical Trials

An Open Label, Randomized, Crossover Study To Estimate The Pharmacokinetics And Evaluate The Safety Following A Single Dose Of Azithromycin 2g Extended-Release Powder For Oral Suspension With A 3-Day Dosing Regimen Of Azithromycin 500mg Tablet In Chinese Healthy Male Subjects

Start date: May 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to estimate the pharmacokinetics and evaluate the safety following a single dose of azithromycin 2g extended-release powder for oral suspension with a 3-day dosing regimen of azithromycin 500mg tablet in Chinese healthy male subjects. This study data will be used to support azithromycin NDA in China.

NCT ID: NCT00875628 Terminated - Healthy Volunteers Clinical Trials

A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers

Start date: April 2009
Phase: Phase 1
Study type: Interventional

Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.

NCT ID: NCT00875030 Completed - Healthy Volunteers Clinical Trials

A Study Comparing Blood Levels After Single-Dose Administration Of Artesunate Sachets (Pfizer) Versus Single-Dose Administration Of Arsuamoon® Tablets (Guilin-China) In Healthy Subjects

Start date: June 2009
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard for artesunate The secondary objective is to assess the safety of Artesunate Sachet (Pfizer) and Arsuamoon® tablet (Guilin China).

NCT ID: NCT00871806 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetics of Two Eletriptan Oral Formulations Given With and Without Water and the Commercial Tablet Formulation Given With Water

Start date: April 2009
Phase: Phase 1
Study type: Interventional

The study will evaluate whether the blood concentrations of eletriptan administered using two test formulations of oral disintegrating tablets are comparable to those observed with the standard commercial tablet.