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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004515
Receipt No. R000005402
Scientific Title The evaluation of the diagnostic methods and the diagnostic criteria of the steroid dependent sensorineural hearing loss
Date of disclosure of the study information 2010/11/08
Last modified on 2012/05/08

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Basic information
Public title The evaluation of the diagnostic methods and the diagnostic criteria of the steroid dependent sensorineural hearing loss
Acronym The evaluation of the steroid dependent sensorineural hearing loss
Scientific Title The evaluation of the diagnostic methods and the diagnostic criteria of the steroid dependent sensorineural hearing loss
Scientific Title:Acronym The evaluation of the steroid dependent sensorineural hearing loss
Region
Japan

Condition
Condition steroid dependent sensorineural hearing loss
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to determine a new diagnostic method and diagnostic criteria of the steroid dependent sensorineural hearing loss
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The clinical course of the patients, and the blood tests
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 Patients who was diagnosed as the steroid dependent sensorineural hearing loss
Key exclusion criteria no
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Inoue
Organization Keio university
Division name school of medicine
Zip code
Address shinanomachi 35 shinnjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Inoue
Organization keio university school of medicine
Division name Department of ORL
Zip code
Address
TEL
Homepage URL
Email yas712@sc.itc.keio.ac.jp

Sponsor
Institute Keio university
Institute
Department

Funding Source
Organization MHLW(Japan)
Organization
Division
Category of Funding Organization
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 慶應義塾大学病院(東京都)、東京医科歯科大学病院(東京都)、杏林大学病院(東京都)、日野市立病院(東京都)、防衛医科大学病院(埼玉県)、岩手医科大学病院(岩手県)、北里大学病院(神奈川県)、岡山大学病院(岡山県)、福岡大学病院(福岡県)、国立成育医療研究センター(東京都)、名古屋大学病院(愛知県)、神戸大学病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2010 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information In this trial,we could find no objective item in order to diagnose the steroid dependent sensorineural hearing loss.
However, we could establish new diagnostic criteria of the disease.

Management information
Registered date
2010 Year 11 Month 08 Day
Last modified on
2012 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005402

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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