UMIN-CTR Clinical Trial

Basic information
Public title	Research of diagnosis support system using analysis of the inquiry items for automatic medical interview
Acronym	Research of diagnosis support system
Scientific Title	Research of diagnosis support system using analysis of the items for automatic medical interview
Scientific Title:Acronym	Research of diagnosis support system using analysis of the items for automatic medical interview
Region	Japan

Condition
Condition	no exclusion
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of the usefulness of the AI learning model by analysis of the inquiry items
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the usefulness of the AI learning model
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	1.a patient who wish to take Kampo medicines to his or her chief complaint(s) 2.a patient who are 20 years or older 3. a patient who agreed with the explanation and consent form of this research
Key exclusion criteria	1.a patient who is not available of the health information or the photo of tongue findings 2.a patient who took Kampo medicines within the past four weeks 3.an inappropriate patient for this research who was judged by medical doctor
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Takao Middle name Last name Namiki
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Japanese-Oriental(Kampo) Medicine,
Zip code	260-8670
Address	1-8-1 Inohana Chuo-ku Chiba-city
TEL	+81-43-226-2984
Email	tnamiki@faculty.chiba-u.jp

Public contact
1st name of contact person	1st name Takao Middle name Last name Namiki
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Japanese-Oriental(Kampo) Medicine
Zip code	260-8670
Address	1-8-1 Inohana Chuo-ku Chiba-city
TEL	+81-43-226-2984
Homepage URL
Email	tnamiki@faculty.chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	Company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Medicine, Chiba University
Address	1-8-1 Inohana Chuo-ku Chiba-city
Tel	043-222-7171
Email	igaku-rinri@office.chiba-u.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	千葉大医学部附属病院

Other administrative information
Date of disclosure of the study information	2019 Year 04 Month 01 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	2018 Year 11 Month 12 Day
Date of IRB	2018 Year 11 Month 12 Day
Anticipated trial start date	2019 Year 04 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Verification of the usefulness of the AI learning model by analysis of the inquiry items for automatic medical interview

Management information
Registered date	2019 Year 03 Month 28 Day
Last modified on	2019 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041383