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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034896
Receipt No. R000039526
Scientific Title Prospective observational study on the clinical course and treatment effect based on QOL evaluation in seasonal influenza
Date of disclosure of the study information 2018/11/15
Last modified on 2018/11/15

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Basic information
Public title Prospective observational study on the clinical course and treatment effect based on QOL evaluation in seasonal influenza
Acronym The QOL study in seasonal influenza
Scientific Title Prospective observational study on the clinical course and treatment effect based on QOL evaluation in seasonal influenza
Scientific Title:Acronym The QOL study in seasonal influenza
Region
Japan

Condition
Condition Seasonal influenza
Classification by specialty
Medicine in general Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To show the clinical course and treatment effect based on QOL evaluation in seasonal influenza
Basic objectives2 Others
Basic objectives -Others To show whether or not there is a difference between the change of symptoms and that of QOL
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The change of QOL score evaluated by questionnaire
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Influenza patients
Key exclusion criteria Patients who admitted over 48hours after initiation of symptoms.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Yoshino
Organization Teikyo university hospital
Division name Internal medicine
Zip code
Address 2-11-1, Kaga, Itabashi, Tokyo
TEL 0339641211
Email yyoshino@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Yoshino
Organization Teikyo university hospital
Division name Internal medicine
Zip code
Address 2-11-1, Kaga, Itabashi, Tokyo
TEL 0339641211
Homepage URL
Email yyoshino@med.teikyo-u.ac.jp

Sponsor
Institute Department of Internal Medicine, Teikyo University School of Medicine
Institute
Department

Funding Source
Organization Department of Internal Medicine, Teikyo University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 TUIC-COI 18-0760
Org. issuing International ID_1 Teikyo University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 帝京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 15 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
2018 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 15 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
2022 Year 04 Month 30 Day
Date trial data considered complete
2022 Year 05 Month 31 Day
Date analysis concluded
2022 Year 06 Month 30 Day

Other
Other related information This study is prospective observational study. We plan to evaluate patient's status by using questionnaire.
We plan to ask patients to send their questionnaire by mail or e-mail twice, one and two weeks after the initiation of observation.

Management information
Registered date
2018 Year 11 Month 15 Day
Last modified on
2018 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039526

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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