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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00456573 |
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Date of registration:
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03/04/2007 |
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Primary sponsor: |
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Public title:
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Cytokine Profiles in Children With Obstructive Sleep Apnea
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Scientific title:
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Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00456573 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Fuad M Baroody, MD |
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Address:
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Telephone:
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773-702-4790 |
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Email:
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fbaroody@surgery.bsd.uchicago.edu |
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Affiliation:
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Name:
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Fuad M Baroody, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Chicago |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- OSA documented by polysomnography and clinical symptoms.
- Patients with no symptoms of OSA and negative sleep questionnaire.
Exclusion Criteria:
- Significant systemic disease except mild asthma
Age minimum:
18 Months
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obstructive Sleep Apnea Syndrome
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Intervention(s)
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Procedure: tonsillectomy
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Primary Outcome(s)
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levels of cytokines released from PBMCs of OAS subjects and controls
[Time Frame: just prior to surgery]
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Secondary Outcome(s)
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cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups
[Time Frame: at time of surgery]
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Secondary ID(s)
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002 (14437B)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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