Pediatric Liver Database
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| First Received Date ICMJE | May 9, 2008 | ||||||||
| Last Updated Date | June 21, 2011 | ||||||||
| Start Date ICMJE | June 2003 | ||||||||
| Estimated Primary Completion Date | June 2018 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00677625 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pediatric Liver Database | ||||||||
| Official Title ICMJE | Pediatric Liver Disease and Liver Transplant Database | ||||||||
| Brief Summary | The purpose of this study is to collect data to examine and characterize the clinical outcomes of pediatric patients diagnosed with any liver disease at Children's Hospital of Wisconsin. |
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| Detailed Description | In this study, medical information which is routinely obtained on children with any liver diseases, or children who have had a liver transplant will be entered into a database. No extra tests are done for participating in this study, and no extra visits to the doctor are required. The clinical data collected is then entered into a database and followed longitudinally. The information obtained from this study will help researchers learn more about pediatric liver disease, therefore providing better routine clinical treatment. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | All child subjects will be recruited from the Hepatology Clinic at Children's Hospital of Wisconsin |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | LD###
These child subjects have some form of liver disease (including those who need a liver transplant) or have already had a liver transplant. |
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| Publications * | Not Provided | ||||||||
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* 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | June 2018 | ||||||||
| Estimated Primary Completion Date | June 2018 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00677625 | ||||||||
| Other Study ID Numbers ICMJE | CHW 03/64 HRRC 188-03 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Grzegorz Telega/Principal Investigator, Medical College of Wisconsin | ||||||||
| Study Sponsor ICMJE | Medical College of Wisconsin | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Medical College of Wisconsin | ||||||||
| Verification Date | June 2011 | ||||||||
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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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