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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004864
Receipt No. R000005427
Scientific Title To establish detecting central nerve resion among vertigo patients in the emergency department
Date of disclosure of the study information 2011/01/13
Last modified on 2017/11/10

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Basic information
Public title To establish detecting central nerve resion among vertigo patients in the emergency department
Acronym To establish detecting central vertigo
Scientific Title To establish detecting central nerve resion among vertigo patients in the emergency department
Scientific Title:Acronym To establish detecting central vertigo
Region
Japan

Condition
Condition vertigo and diziness
Classification by specialty
Neurology Neurosurgery Emergency medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish detecting central nerve resion among vertigo patients in the emergency department
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Brain hemorrhage or brain infarction detected by head CT or MRI.
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 Patients who are complained with dizziness or vertigo, came to emergency room of National Center of Global Health and Medicine, Japan by the ambulance.
Key exclusion criteria Dizziness or vertigo which is caused by external reason such as trauma or toxicity, or patients who are coma at the time they come to emregency room.
Target sample size 1800

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akio Kimura
Organization National Center for Global Health and Medicine, Japan
Division name Department of Emergency Medicine and Critical Care
Zip code
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Email takusato@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takunori Sato
Organization National Center for Global Health and Medicine, Japan
Division name Department of Emergency Medicine and Critical Care
Zip code
Address 1-21-1, Toyama, Shinjuku-ku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email rinrijm@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine, Japan
Institute
Department

Funding Source
Organization The Ministry of Health, Labour and Welfare department lab fee
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
2011 Year 01 Month 13 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
2010 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2017 Year 11 Month 10 Day

Other
Other related information Compare between dizziness or vertigo cause of brain hemorrhage or brain infarction and cause of exept brain hemorrhage or brain infarction, with patients' vital signs and labo data.

Management information
Registered date
2011 Year 01 Month 13 Day
Last modified on
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005427

Research Plan
Registered date File name
2018/01/20 めまい研究計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/01/28 diz_whole data.xlsx


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