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Main
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Note: This record shows only 22 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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000027260 |
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Date of registration:
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07/05/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loading
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Scientific title:
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Analysis of Airway Inflammatory state alteration after intravenous L-Arginine loading - Alteration of Airway Inflammatory state after intravenous L-Arginine loading(AILA) |
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Date of first enrolment:
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2017/02/06 |
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Target sample size:
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15 |
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Recruitment status: |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031226 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Haruo Shintaku |
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Address:
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1-4-5,Asahi-machi,Abeno-ku,Osaka city,Osaka
Japan |
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Telephone:
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06-6645-3816 |
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Email:
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m2017993@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Graduate School of Medicine Department of Pediatrics |
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Name:
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Saki Kasuga |
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Address:
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1-4-5,Asahi-machi,Abeno-ku,Osaka city,Osaka
Japan |
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Telephone:
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06-6645-3816 |
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Email:
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m2017993@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Graduate School of Medicine Department of Pediatrics |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Exclusion criteria are following items 1)Patients who are diagnosed with allergy of L-arginine 2) Patients who have used any steroid medications within one month 3) Either the investigator or the co-investigator judged as inappropriate patient for this clinical research
Age minimum:
2years-old
Age maximum:
15years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Children who are required growth hormone (GH) stimulation tests to diagnose GH deficiency. These are children whose heights are two standard deviations (SD) below the mean for age and sex, and/or whose growth velocities are 1.5 SD below the mean for age and sex over 2 years' follow-up, or whose pediatric endocrinologists order growth hormone (GH) stimulation test for another reasons.
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Intervention(s)
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Dosing 500mg/kg L-arginine (maximal dose 30g) intravenous drip in 30minutes
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Primary Outcome(s)
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The alteration rate of oxidative stress level before L-arginine loading and 120 minutes after.
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Secondary Outcome(s)
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In addition to the above mentioned items, the following items is investigated, including; (1) The alteration rate of oxidative stress level, arginine level, pteridines level before L-arginine loading and 30,60,90,120 minutes after and next day in serum. (2) Correlation between FeNO and oxidative stress level at each point. (3) Correlation between FeNO and pteridines level at each point. (4) Correlation between oxidative stress level and pteridines level at each point.
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Source(s) of Monetary Support
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Osaka City University Graduate School of Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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