UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014376 |
|---|---|
| Receipt number | R000016732 |
| Scientific Title | Basic and clinical study based on mass survey among residents in temporary-dwelling of the Great East Japan Earthquake |
| Date of disclosure of the study information | 2014/06/25 |
| Last modified on | 2015/04/14 19:35:58 |
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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
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
n-tsurikisawa@sagamihara-hosp.gr.jp
Sponsor or person
Institute
National Institute of Health Sciences,
National Hospital Organization, Sagamihara Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016732
