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Genotypic Variations clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT00918359 Recruiting - Gene Expression Clinical Trials

Heat Intolerance- A Lesson From Global Genomic Response in Lymphocytes

Start date: May 2009
Phase: N/A
Study type: Observational

Heat Intolerance (HI) is a life threatening deficiency that can lead to heat exhaustion, heat stroke (and possibly death) in a large number of military and civilian occupational groups. We have demonstrated malfunction of transcriptional pathways in the heat stressed HI phenotype and an altered gene expression profile compared to Heat Tolerant (HT) individuals. Such differences are evident even under normothermic basal/comfort conditions. Heat and exercise challenges during the heat tolerance test (HTT) further emphasize the differences between the groups, particularly during recovery at comfort temperatures. Our results indicate that it may be possible to identify markers of heat intolerance. To achieve this goal, we plan to design a cellular (lymphocyte) HTT experimental model and detect gene expression profiles using customized DNA microarrays and bioinformatic tools (the genes selected will be based on our previous DNA microarray studies). Lymphocyte samples collected from HT and HI individuals under resting/comfort conditions will be examined. Treatments and analyses are designed to reveal HI-associated gene-expression profiles (constitutive or inducible), and thereby find lymphocyte markers to identify individuals predisposed to heat injury. The identification of such subjects could prevent unnecessary loss of life. Notably, the rapidly changing climate in our era increases the number of occupation/age groups in which manifestations of HI will appear.