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

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 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


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

Value
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