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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035152
Receipt No. R000035048
Scientific Title Factors on electrocardiogram change in big data
Date of disclosure of the study information 2018/12/06
Last modified on 2018/12/10

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Basic information
Public title Factors on electrocardiogram change in big data
Acronym Factors on electrocardiogram change in big data
Scientific Title Factors on electrocardiogram change in big data
Scientific Title:Acronym Factors on electrocardiogram change in big data
Region
Japan

Condition
Condition Dental
Classification by specialty
Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 investigation for Factors on electrocardiogram change in big data
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes electrocardiogram change
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria General anesthesia or intravenous anesthesia patients in dental
Key exclusion criteria No electrocardiogram data patients
Target sample size 4000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Ouchi
Organization Kyushu University
Division name Dental sience
Zip code
Address Maidashi 3-1-1
TEL 092-641-1151
Email ken2006anes@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Ouchi
Organization Kyushu University
Division name Dental sience
Zip code
Address Maidashi 3-1-1
TEL 092-641-1151
Homepage URL
Email ken2006anes@yahoo.co.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization Kyushu University
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

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
2018 Year 12 Month 06 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
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information electrocardiogram, anesthesia record

Management information
Registered date
2018 Year 12 Month 06 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035048

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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