UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037166
Receipt number 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 14:18:18

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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 or person

Institute

National Center for Child Health and Development

Institute

Department

Personal name



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

Value
https://center6.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