UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034896 |
|---|---|
| Receipt number | 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 10:23:39 |
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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
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
yyoshino@med.teikyo-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Teikyo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039526
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
