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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013561
Receipt No. R000015842
Scientific Title Prospective review of medical records related to allergy.
Date of disclosure of the study information 2014/03/31
Last modified on 2017/10/13

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Basic information
Public title Prospective review of medical records related to allergy.
Acronym Prospective review of medical records related to allergy.
Scientific Title Prospective review of medical records related to allergy.
Scientific Title:Acronym Prospective review of medical records related to allergy.
Region
Japan

Condition
Condition Food allergy, atopic dermatitis, bronchial asthma
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To contribute to improving treatments and diagnostic methods of allergy by analyzing the present medical record
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence of food allergy
The presence of atopic dermatitis
The presence of bronchial athma
Key secondary outcomes The results of oral food challenge test
Laboratory data of blood exam
The safety of oral food challenge tests
The severity of eczema
Height

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases related to food allergy and atopic dermatitis
Key exclusion criteria Cases unrelated to allergy
Cases judged inadequate by medical doctor
Target sample size 6000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiro Ebisawa
Organization National Hospital Organization
Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL 042-742-8311
Email foodallergy@sagamihara-hosp.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Yanagida
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL 042-742-7311
Homepage URL
Email n-yanagida@sagamihara-hosp.gr.jp

Sponsor
Institute National Hospital Organization
Sagamihara National Hospital
Institute
Department

Funding Source
Organization Research grant by the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To contribute to improving treatments and diagnostic methods of allergy by analyzing the present medical record

Management information
Registered date
2014 Year 03 Month 30 Day
Last modified on
2017 Year 10 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015842

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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