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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045746
Receipt No. R000052223
Scientific Title A cross-sectional study for healthcare parameters in adult men and women
Date of disclosure of the study information 2021/10/14
Last modified on 2021/10/13

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Basic information
Public title A cross-sectional study for healthcare parameters in adult men and women
Acronym A cross-sectional study for healthcare parameters in adult men and women
Scientific Title A cross-sectional study for healthcare parameters in adult men and women
Scientific Title:Acronym A cross-sectional study for healthcare parameters in adult men and women
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate relationships with multiple healthcare parameters
Basic objectives2 Others
Basic objectives -Others To investigate relationships with multiple healthcare parameters
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Search for relationships with multiple healthcare parameters
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Healthy adults
-Subjects who can answer questionnaire
-Subjects who have given written informed consent
Key exclusion criteria -Subjects under hospital treatment
-Subjects who cannot visit clinic by oneself
- Subjects who have been diagnosed with dementia or are suspected of having dementia
->=60 years old and have not received COVID-19 vaccine
-Suspected of being infected with COVID-19
-Pacemaker users or pregnancies
-Subjects who have donated over 200 mL of blood within the last one month or over 400 mL of blood within the last three months
-Subjects who are judged to be inappropriate for the study by the medical doctor or investigator
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Masanobu
Middle name
Last name Hibi
Organization Kao Corporation
Division name Biological Science Research
Zip code 131-8501
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL +81-3-5630-7260
Email hibi.masanobu@kao.com

Public contact
Name of contact person
1st name Toshiyasu
Middle name
Last name Tamura
Organization TES Holdings Co. Ltd
Division name Department of Development for Clinical Trials
Zip code 110-0015
Address Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan
TEL +81-3-6801-8480
Homepage URL
Email t.tamura@tes-h.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Preferred Networks, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-7263
Email morisaki.naoko@kao.com

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 うえのあさがおクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 14 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 Preinitiation
Date of protocol fixation
2021 Year 10 Month 05 Day
Date of IRB
2021 Year 10 Month 05 Day
Anticipated trial start date
2021 Year 10 Month 19 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate relationships with multiple healthcare parameters

Management information
Registered date
2021 Year 10 Month 13 Day
Last modified on
2021 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052223

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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