The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System
Recruitment status was Not yet recruiting
Tracking Information | |||||
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First Received Date ICMJE | November 3, 2010 | ||||
Last Updated Date | November 27, 2010 | ||||
Start Date ICMJE | January 2011 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01237548 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System | ||||
Official Title ICMJE | |||||
Brief Summary | Title: The acute effect of narghile smoking on endothelial Function, and exhaled breath condensate (EBC) and pulmonary function tests in healthy volunteers. Objectives: To evaluate the acute effect of one cession of narghile smoking on endothelial Function, airway inflammation as assessed by exhaled breath condensate (EBC) in healthy volunteers. Design: Prospective study evaluating these parameters before and after 30 minutes of Narghile smoking. The changes in inflammatory parameters pre and post smoking will be evaluated blindly. Sample size: 50 participants Participant selection: Adults subjects who smoke Narghile . Intervention: Each subject will undergo evaluation including a respiratory questionnaire, endothelial Function , pulmonary function tests , exhaled breath condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession of 30 minutes narghile smoking. |
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Detailed Description | |||||
Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Normal People who have smoked Water-pipe, at least once before. |
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Condition ICMJE | Healthy | ||||
Intervention ICMJE | Other: Smoking Narghile for 30 min
No Other intervention will be used |
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Study Group/Cohort (s) | All participants
Normal People who have smoked Water-pipe, at least once before.
Intervention: Other: Smoking Narghile for 30 min |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 50 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | Israel | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01237548 | ||||
Other Study ID Numbers ICMJE | Narghile Endotheil RMC 284 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Prof. Lea Bentur, Rambam Health Care Campus | ||||
Study Sponsor ICMJE | Rambam Health Care Campus | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Rambam Health Care Campus | ||||
Verification Date | August 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |