UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038265 |
|---|---|
| Receipt number | R000043615 |
| Scientific Title | fatigue after night shift of doctors study |
| Date of disclosure of the study information | 2019/10/20 |
| Last modified on | 2019/10/10 15:47:59 |
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Basic information
Public title
fatigue after night shift of doctors study
Acronym
Mitoyo doctors study
Scientific Title
fatigue after night shift of doctors study
Scientific Title:Acronym
MDS
Region
| Japan |
Condition
Condition
fatigue
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the degree of fatigue after night shifts and assess whether to work on the day after night shifts
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective symptoms of fatigue, flicker test, perspective vision, blood pressure, pulse rate, salivary amylase activity
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
| 24 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Physician working at a general hospital and working night shift
Key exclusion criteria
None
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Yamauchi |
Organization
Mitoyo General Hospital
Division name
Internal medicine
Zip code
769-1695
Address
708 Himehama, Toyohama cho, Kannonji, Kagawa
TEL
0875-52-3366
yamauchi.kenji@hotmail.com
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Yamauchi |
Organization
Mitoyo General Hospital
Division name
Internal medicine
Zip code
769-1695
Address
708 Himehama, Toyohama cho, Kannonji, Kagawa
TEL
0875-52-3366
Homepage URL
yamauchi.kenji@hotmail.com
Sponsor or person
Institute
Mitoyo General Hospital
Institute
Department
Personal name
Funding Source
Organization
Mitoyo General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mitoyo General Hospital
Address
708 Himehama, Toyohama cho, Kannonji, Kagawa
Tel
0875-52-3366
yamauchi.kenji@hotmail.com
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 | 10 | Month | 20 | 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 | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N.P.
Management information
Registered date
| 2019 | Year | 10 | Month | 10 | Day |
Last modified on
| 2019 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043615
| Research Plan | |
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| 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 |
