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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: |
NCT00138450 |
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Date of registration:
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26/08/2005 |
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Primary sponsor: |
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Public title:
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Urinary Schistosomiasis Infection
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Scientific title:
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Village Surveys of Morbidity Due to S. Haematobium for 1U01AI4547 Urinary Schistosomiasis-Determinants of Infection and Disease |
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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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4400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00138450 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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Kenya
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Kenyan residents, newborn to adult, either male or female.
2. Residence in areas of Kwale District endemic for Schistosoma haematobium
Exclusion Criteria:
Pregnancy (this is a partial exclusion). Pregnant women will participate in the
parasitological screening phase of the study. However, because of pregnancy-related
effects on the urinary system, their ultrasound examinations will be excluded from the
analysis of hydronephrosis. Further, because of potential toxicity of praziquantel
(Category B) and its alternative, metrifonate (an anticholinesterase), post-protocol
anti-parasitic therapy will be delayed until the mother delivers and has stopped
breastfeeding her infant.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diseases of the Urinary System
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Schistosomiasis [Bilharziasis]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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