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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017907
Receipt No. R000020749
Scientific Title Trigeminal and taste sensation of the tongue after surgery in patients with otosclerosis : Activation of MAP kinase in Geniculate ganglion neurons after middle ear surgery
Date of disclosure of the study information 2015/06/30
Last modified on 2016/12/15

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Basic information
Public title Trigeminal and taste sensation of the tongue after surgery in patients with otosclerosis : Activation of MAP kinase in Geniculate ganglion neurons after middle ear surgery
Acronym Trigeminal and taste sensation of the tongue after surgery in patients with otosclerosis : Activation of MAP kinase in Geniculate ganglion neurons after middle ear surgery
Scientific Title Trigeminal and taste sensation of the tongue after surgery in patients with otosclerosis : Activation of MAP kinase in Geniculate ganglion neurons after middle ear surgery
Scientific Title:Acronym Trigeminal and taste sensation of the tongue after surgery in patients with otosclerosis : Activation of MAP kinase in Geniculate ganglion neurons after middle ear surgery
Region
Japan

Condition
Condition otosclerosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate trigeminal sensations of the tongue after middle ear surgery with otosclerosis.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes In the patients with otosclerosis, postoperative thresholds were significantly higher than preoperative thresholds.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 To investigate trigeminal sensations of the tongue after middle ear surgery with otosclerosis.
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
6 years-old <
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria All patients with otosclerosis who undergo surgery in our department.
Key exclusion criteria none
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsura Hirokazu
Organization Hyogo college of medicine
Division name Department of Otolaryngology,Head and Neck surgery
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo
TEL 0798-45-6111
Email hkatsura@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsura Hirokazu
Organization Hyogo college of medicine
Division name Department of Otolaryngology,Head and Neck surgery
Zip code
Address 1-1 Mukogawacho, Nishinomiya, Hyogo
TEL 0798-45-6111
Homepage URL
Email hkatsura@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Other
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
2015 Year 06 Month 30 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 Completed
Date of protocol fixation
2015 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 15 Day
Last modified on
2016 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020749

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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