UMIN-CTR Clinical Trial

Basic information
Public title	Basic and clinical study based on mass survey among residents in temporary-dwelling of the Great East Japan Earthquake
Acronym	Study based on mass survey among residents in temporary-dwelling of the Great East Japan Earthquake
Scientific Title	Basic and clinical study based on mass survey among residents in temporary-dwelling of the Great East Japan Earthquake
Scientific Title:Acronym	Study based on mass survey among residents in temporary-dwelling of the Great East Japan Earthquake
Region	Japan

Condition
Condition	asthma hypersensitive pneumonitis
Classification by specialty	Pneumology Clinical immunology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Early detection and rapid cure of upper respiratory allergies by fungal contamination, and avoidance of the health hazard by fungal contamination of temporary-dwelling environments.
Basic objectives2	Others
Basic objectives -Others	Analysis of the risk factors for the development of fungal allergies among residents in the temporary houses.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of upper respiratory diseases among among residents in the temporary houses.
Key secondary outcomes

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	15 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Residents in the temporary houses in the Great East Japan Earthquake
Key exclusion criteria	Not applicable
Target sample size	800

Research contact person
Name of lead principal investigator	1st name Middle name Last name Maiko Watanabe
Organization	National Institute of Health Sciences
Division name	Division of microbiology
Zip code
Address	1-18-1 Kamiyoga, Setagaya-ku, Tokyo
TEL	03-3700-1141
Email	mwatanabe@nihs.go.jp

Public contact
Name of contact person	1st name Middle name Last name Naomi Tsurikisawa
Organization	National Hospital Organization, Sagamihara Hospital
Division name	Clinical Research Centre for Allergy and Rheumatology
Zip code
Address	18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa
TEL	042-742-8311
Homepage URL
Email	n-tsurikisawa@sagamihara-hosp.gr.jp

Sponsor
Institute	National Institute of Health Sciences, National Hospital Organization, Sagamihara Hospital
Institute
Department

Funding Source
Organization	National Institute of Health Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japanese Red Cross Ishinomaki Hospital, Iwate University
Name of secondary funder(s)	National Hospital Organization, Sagamihara Hospital

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 06 Month 25 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	Open public recruiting
Date of protocol fixation	2014 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date	2014 Year 06 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective study

Management information
Registered date	2014 Year 06 Month 25 Day
Last modified on	2015 Year 04 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016732

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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