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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037166
Receipt No. R000042351
Scientific Title Clinical and radiological features of encephalopathy caused by shiga toxin producing enterohemorrhagic Escherichia coli, case series study
Date of disclosure of the study information 2019/06/28
Last modified on 2019/06/25

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Basic information
Public title Clinical and radiological features of encephalopathy caused by shiga toxin producing enterohemorrhagic Escherichia coli, case series study
Acronym Clinical and radiological features of encephalopathy caused by shiga toxin producing enterohemorrhagic Escherichia coli, case series study
Scientific Title Clinical and radiological features of encephalopathy caused by shiga toxin producing enterohemorrhagic Escherichia coli, case series study
Scientific Title:Acronym Clinical and radiological features of encephalopathy caused by shiga toxin producing enterohemorrhagic Escherichia coli, case series study
Region
Japan

Condition
Condition encephalopathy caused by shiga toxin producing enterohemorrhagic Escherichia coli
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe the clinical and radiological features of encephalopathy caused by shiga toxin producing enterohemorrhagic Escherichia coli in our country.
Basic objectives2 Others
Basic objectives -Others Case series study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes encephalopathy caused by shiga toxin producing enterohemorrhagic Escherichia coli
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
15 years-old >
Gender Male and Female
Key inclusion criteria Patients of encephalopathy caused by enterohemorrhagic escherichia coli infections from June 1st 2011 to December 31th 2018 in Japan.
Key exclusion criteria 1. Cases which researches cannot reach the information.
2. Cases whose form of questionnaire is not detailed.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Igarashi
Organization National center for child health and development
Division name Center
Zip code 157-8535
Address 2-10-1, Ookura, Setagaya ward, Tokyo
TEL 03-3416-0181
Email igarashi-t@ncchd.go.jp

Public contact
Name of contact person
1st name Isao
Middle name
Last name Miyairi
Organization National Center for Child Health and Development
Division name Division of Infectious diseases
Zip code 157-8535
Address 2-10-1, Ookura, Setagaya ward, Tokyo
TEL 03-3416-0181
Homepage URL
Email miyairi-s@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization Ministry of Health, Labour, and Welfare
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 National Center for Child Health and Development
Address 2-10-1, Ookura, Setagaya ward, Tokyo
Tel 03-3416-0181
Email hagino-k@ncchd.go.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 06 Month 28 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
2019 Year 06 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Not applicable

Management information
Registered date
2019 Year 06 Month 25 Day
Last modified on
2019 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042351

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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