UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047476 |
|---|---|
| Receipt number | R000054144 |
| Scientific Title | Additional acquisition of healthy subjects in the previous study "Longitudinal Observational Study of Atypical Pain in the Oral-Facial Region by Brain Imaging Analysis". |
| Date of disclosure of the study information | 2022/04/13 |
| Last modified on | 2023/08/23 13:32:34 |
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Basic information
Public title
Additional acquisition of healthy subjects in the previous study "Longitudinal Observational Study of Atypical Pain in the Oral-Facial Region by Brain Imaging Analysis" (July 1, 2017 - July 31, 2021).
Acronym
Additional acquisition of healthy subjects in the previous study.
Scientific Title
Additional acquisition of healthy subjects in the previous study "Longitudinal Observational Study of Atypical Pain in the Oral-Facial Region by Brain Imaging Analysis".
Scientific Title:Acronym
Additional acquisition of healthy subjects.
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subjects in this study were 40 healthy adults (matched for age and gender with 24 patients with Atypical Odontalgia (AO) enrolled in a previous study (UMIN000029226). The subjects will be enrolled to schedule two imaging measurements in the first and second brain imaging time periods matched with those of the AO patients in the previous study (mean: 222 days).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Head Magnetic Resonance Imaging data
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
1) Must be 20 years of age or older and in good health (no medical conditions requiring treatment are indicated in the medical examination).
2 Be able to tolerate relatively loud noise (noise during MRI imaging).
Key exclusion criteria
1) Patients with serious systemic complications such as heart failure, renal failure, liver failure, and respiratory failure
2) Patients with severe psychosis or psychiatric symptoms that make it difficult for them to participate in the study
3) Patients with a history of claustrophobia or fear of the dark, who are deemed to have difficulty participating in MRI imaging
4) Patients with metal in the body (for MRI imaging).
5) Pregnant women.
Translated with www.DeepL.com/Translator (free version)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Ogino |
Organization
Gunma University Hospital
Division name
Anesthesiology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi-shi
TEL
0272208454
oginoyuichi@me.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Ogino |
Organization
Gunma University Hospital
Division name
Anesthesiology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi-shi
TEL
0272208454
Homepage URL
oginoyuichi@me.com
Sponsor or person
Institute
SHIZUOKA CITY SHIMIZU HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
SHIZUOKA CITY SHIMIZU HOSPITAL
Address
1231 Miyakami, Shimizu-ku, Shizuoka-shi
Tel
0543361111
oginoyuichi@me.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
静岡市立清水病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 13 | 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
40
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
| 2022 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 04 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054144
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| Registered date | File name |
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| Registered date | File name |
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