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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 4, 2008 | ||||
| Last Updated Date | January 4, 2008 | ||||
| Start Date ICMJE | January 2007 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
SPECT brain imaging [ Time Frame: after completion of HBOT ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
clinical history and physical exam [ Time Frame: after completion of HBOT ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning | ||||
| Official Title ICMJE | Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Carbon Monoxide Poisoning | ||||
| Brief Summary | That SPECT brain imaging tracks and is consistent with clinical history and physical exam as well as cognitive testing. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Non-Acute Carbon Monoxide Poisoning | ||||
| Intervention ICMJE | Drug: HBOT | ||||
| Study Arms / Comparison Groups | Experimental: HBOT | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | December 2008 | ||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00596180 | ||||
| Responsible Party | Paul G. Harch, M.D., LSU School of Medicine | ||||
| Study ID Numbers ICMJE | LSU IRB #6626 | ||||
| Study Sponsor ICMJE | Louisiana State University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Louisiana State University | ||||
| Verification Date | December 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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