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| Tracking Information | |||||
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| First Received Date ICMJE | June 27, 2006 | ||||
| Last Updated Date | June 16, 2008 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00345280 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ocular Surface Changes in Patients With Cystic Fibrosis | ||||
| Official Title ICMJE | Chosen Parameters of the Immune Response in the Origin of Ocular Changes in Patients With Cystic Fibrosis | ||||
| Brief Summary | Cystic fibrosis(CF) is an inherited disease affecting children, adolescents and young adults with dysfunction of secretory glands.It is caused by mutations in the protein-coding gene which function as the cystic fibrosis transmembrane regulator (CFTR), responsible for the secretion of chloride ions in epithelial cells, adenocytes, sweat gland cells, pancreatic ducts,alimentary and respiratory tracts and eye. Assessment of the relationship between the inflammatory processes and apoptosis in the eye in the course of cystic fibrosis will allow determination of immunological exponents which may facilitate diagnosis. |
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| Detailed Description | The aim: To assess the role of chosen parameters of immunological response in the induction of ocular changes in cystic fibrosis patients, particularly chosen chemokine concentrations in the tear fluid and analysis of chosen apoptotic markers expression on conjunctival epithelial cells. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Condition ICMJE | Eye Manifestations | ||||
| Intervention ICMJE | Procedure: impression cytology, obtain the tear fluid
Vitamin A
Other Name: Becton Dickinson |
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| Study Arms / Comparison Groups | |||||
| 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 | 26 | ||||
| Estimated Completion Date | September 2008 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 3 Years to 25 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Poland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00345280 | ||||
| Responsible Party | Malgorzata Mrugacz, Medical University of Bialystok, Poland | ||||
| Study ID Numbers ICMJE | 8789, N40605131/1894 | ||||
| Study Sponsor ICMJE | University of Bialystok | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Bialystok | ||||
| Verification Date | June 2008 | ||||
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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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