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NCT ID: NCT00693160 Terminated - Healthy Clinical Trials

Effect of Spinal Ketorolac After Acute Opioid Exposure

Start date: December 2007
Phase: Phase 2
Study type: Interventional

This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous [IV] narcotic painkiller): 1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream? 2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?

NCT ID: NCT00671593 Terminated - Healthy Clinical Trials

Differential Gene Expression in Lung and Peripheral Blood After Inhaled Allergen Challenge

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

The purpose of this study is to identify the genes in important airway cells that are specifically expressed following inhalation of house dust mite allergen among study subjects with either allergic asthma or healthy normal phenotypes. This approach is designed to identify novel genes associated with both asthma pathogenesis (differentially expressed in the exposure-response study) and asthma susceptibility (genetically associated with asthma in a linkage/association study) for drug targets.

NCT ID: NCT00663065 Terminated - Healthy Clinical Trials

A Study of the Safety of PAZ-417 in Healthy Elderly Adults

Start date: April 2008
Phase: Phase 1
Study type: Interventional

This is study to determine the safety of PAZ-417 in healthy adults over 65.

NCT ID: NCT00656318 Terminated - Healthy Clinical Trials

Impact of Oral Contraceptives on GABA and Neurosteroids

Start date: August 2008
Phase: N/A
Study type: Observational

Thus, the proposed study has the following Specific Aims and Hypotheses: 1. To determine in menstruating women ages 18-45 whether an OCP containing ethinyl estradiol (EE) and the progestin ethinydiol diacetate (ED) increases cortical GABA concentrations as measured using proton magnetic resonance spectroscopy (1H-MRS) above that of an OCP containing EE and the progestin norethindrone (NOR). 2. To determine the relationship between changes in occipital GABA concentrations with acute OCP administration and negative affect with chronic OCP administration over two menstrual cycles.

NCT ID: NCT00648414 Terminated - Healthy Clinical Trials

Study of the Effect of Clinical Procedures on Drug Delivery of Mylan Fentanyl Transdermal System 25 µg/hr and Duragesic® 25 µg/hr

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

The objective of this study was to investigate the effect of clinical procedures on the drug delivery of Fentanyl Transdermal Systems, 25 mcg/h manufactured for Mylan Pharmaceuticals Inc. by Mylan Technologies Inc., and Duragesic, 25 mcg/h manufactured for Janssen Pharmaceutica by ALZA Corporation.

NCT ID: NCT00647972 Terminated - Healthy Clinical Trials

Fasting Study of Olanzapine Tablets 20 mg and Zyprexa® Tablets 20 mg

Start date: May 2003
Phase: Phase 1
Study type: Interventional

The objective of this study was to investigate the bioequivalence of Mylan olanzapine 20 mg tablets to Eli Lilly Zyprexa® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions.

NCT ID: NCT00644592 Terminated - Healthy Clinical Trials

LXRA Gene Polymorphisms and Response to Fenofibrate

Start date: March 2008
Phase: N/A
Study type: Interventional

This is a research study of how a cholesterol medication known as fenofibrate works differently in people with different genetic backgrounds. "Genetics" refers to certain things that are passed to a person by their parents, such as eye color or hair color. Genetic differences lead to people having different eye and hair color. There are also genetic differences in a protein called liver X receptor-alpha (LXRA), which may be important in predicting the response to fenofibrate.

NCT ID: NCT00644514 Terminated - Healthy Clinical Trials

Genetics of Asthma - Bronchoscopy Studies

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

The purpose of this study is to identify the mediators and genes in airway epithelial and BAL cells that are differentially regulated following inhalation of endotoxin lipopolysaccharide (LPS) among study participants with allergic asthma and normal phenotypes. This approach is designed to identify novel genes associated with both asthma pathogenesis and asthma susceptibility. LPS, or endotoxin, a cell wall component of gram-negative bacteria, is ubiquitous in the environment, and is thought to influence both susceptibility and severity of asthma. 240 subjects (healthy adult men and women (age >18-40) with and without atopy and asthma) will complete the screening evaluations in order to establish 3 study groups of 60 subjects each. Each qualified subject will undergo an inhaled LPS endotoxin challenge followed by bronchoscopy after 24 hours, which will consist of a bronchoalveolar lavage (BAL) and endobronchial brush biopsies. BAL involves squirting a small amount of sterile salt water into one of the airways then gently taking it back out through the bronchoscope. The brush sample involves gently moving a small brush back and forth in an airway to collect cell samples. Samples of whole blood will also be obtained at various time points. RNA will be isolated from these cell populations in order to assess differential gene expression expression using microarrays.

NCT ID: NCT00643721 Terminated - Healthy Clinical Trials

Body Water Content Sensor

Start date: September 2007
Phase:
Study type: Observational

Evaluation of hydration status during exercise and heat exposure.

NCT ID: NCT00643058 Terminated - Healthy Clinical Trials

Nitric Oxide, LPS and the Pathogenesis of Asthma Phase II

Start date: April 2003
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the role of nitric oxide (NO) in asthma and to characterize the symptoms associated with inhaled endotoxin (lipopolysaccharide [LPS]) in normal subjects. In this study, we will determine the effect of inhaled endotoxin on exhaled NO in healthy African Americans, with and without NOS2 promoter polymorphisms. The protocol described in this submission will involve the use of NIH Clinical Center Reference Endotoxin which has been approved by the FDA under IND BB-IND-10035.