UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038090
Receipt number R000043415
Scientific Title The experiment of Wellness Support System in Sep 2019
Date of disclosure of the study information 2019/09/24
Last modified on 2020/03/25 10:30:04

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Basic information

Public title

The experiment of Wellness Support System in Sep 2019

Acronym

The experiment of Wellness Support System in Sep 2019

Scientific Title

The experiment of Wellness Support System in Sep 2019

Scientific Title:Acronym

The experiment of Wellness Support System in Sep 2019

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Objectives are to gather the basic data for the algorithm development.

Basic objectives2

Others

Basic objectives -Others

Research

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Face image,Heart rate,Environmental data

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Refresh

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

1. Age 20 years and older
2. Males and females
3.Those who have a lot of business
4. Those who can submit an informed consent document.

Key exclusion criteria

1. Those who are currently receiving treatment for some kind of systemic disease.
2. Those who were determined by the principal investigator to be unsuitable for participation in this study.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Kazuyoshi
Middle name
Last name Harimoto

Organization

TAISEI Corporation

Division name

Urbsan Engineering Research Department

Zip code

245-0051

Address

344-1,Nase-cho,Totsuka-ku,Yokohama,Japan

TEL

090-9026-7660

Email

kazuyoshi.harimoto@sakura.taisei.co.jp


Public contact

Name of contact person

1st name Kazuyoshi
Middle name
Last name Harimoto

Organization

TAISEI Corporation

Division name

Urban Engineering Research Department

Zip code

245-0051

Address

344-1,Nase-cho,Totsuka-ku,Yokohama,Japan

TEL

090-9026-7660

Homepage URL


Email

kazuyoshi.harimoto@sakura.taisei.co.jp


Sponsor or person

Institute

TAISEI Corporation
KANEKA Corporation

Institute

Department

Personal name



Funding Source

Organization

TAISEI Corporation
KANEKA Corporation

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Suda Clinic institutional review board

Address

2-8-14, Takadanobaba, Shinjyuku, Tokyo, Japan

Tel

0362056222

Email

suda-clinic_irb@imeq.co.jp


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

2019 Year 09 Month 24 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

10

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

Completed

Date of protocol fixation

2019 Year 09 Month 09 Day

Date of IRB

2019 Year 09 Month 24 Day

Anticipated trial start date

2019 Year 09 Month 25 Day

Last follow-up date

2020 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 09 Month 24 Day

Last modified on

2020 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043415


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name