UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047157 |
|---|---|
| Receipt number | R000052667 |
| Scientific Title | A pilot study to investigate body temperature in individuals |
| Date of disclosure of the study information | 2022/03/12 |
| Last modified on | 2023/03/25 13:23:44 |
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Basic information
Public title
A pilot study to investigate body temperature in individuals
Acronym
A pilot study to investigate body temperature in individuals
Scientific Title
A pilot study to investigate body temperature in individuals
Scientific Title:Acronym
A pilot study to investigate body temperature in individuals
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will clarify the distribution of body temperature in healthy individuals by using data from health checkup recipients. In addition, by linking the normal body temperature with the health checkup data, we will clarify the meaning of each individual's body temperature and whether there is any relationship between the normal body temperature and the disease diagnosed in the health checkup.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Information on body temperature of medical checkup recipients
Key secondary outcomes
To clarify the relationship between medical information obtained from patients and normal body temperature information, and to identify factors that affect normal body temperature.
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
Recipients who underwent medical checkups at MedCity21 from the date of permission to conduct the research by the head of the research institution until the end of March 2025.
Key exclusion criteria
Those whose body temperature exceeds 37.5C due to obvious infection, etc., and could not undergo medical checkup.
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nadatani |
Organization
Osaka city university
Division name
Department of Premier Preventive Medicine
Zip code
5458585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
0666453946
dada@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | yuji |
| Middle name | |
| Last name | Nadatani |
Organization
Osaka city university
Division name
Premier Preventive Medicine
Zip code
5458585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3946
Homepage URL
dada@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Osaka city university and UsTEC.Co.,INC.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
UsTEC.Co.,INC.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
Tel
0666453456
ethics@med.osaka-cu.ac.jp
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
大阪市立大学附属健診施設MedCity21 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NONE
Management information
Registered date
| 2022 | Year | 03 | Month | 12 | Day |
Last modified on
| 2023 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052667
