UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048800 |
|---|---|
| Receipt number | R000055615 |
| Scientific Title | Verification of headache AI diagnosis by using electronic headache diary in telemedicine. |
| Date of disclosure of the study information | 2022/08/31 |
| Last modified on | 2023/09/01 11:10:57 |
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Basic information
Public title
Verification of headache AI diagnosis by using electronic headache diary in telemedicine.
Acronym
AI diagnosis of headache
Scientific Title
Verification of headache AI diagnosis by using electronic headache diary in telemedicine.
Scientific Title:Acronym
AI diagnosis of headache
Region
| Japan |
Condition
Condition
headache
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is verification of headache AI diagnosis by using electronic headache diary in telemedicine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validate diagnostic concordance rate of cases
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.Patient who has mobile phone and can use application daily.
2.Patient who has recurrent primary headache with secondary headache ruled out.
Key exclusion criteria
1.Patient who is pregnant or hope pregnancy between this clinical study.
2.Diagnosed as hemiplegic migraine
3.Patient who has serious cardiac, liver, renal, hematologic, and pulmonary disease.
4.Patient who has depression and other psychiatric disorders.
5.Medication overuse headache
6.Patient who consumes more than 400mg of caffeine per day.
7.Patients deemed inappropriate by the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Okada |
Organization
Saitama Medical University
Division name
Neurology
Zip code
350-0495
Address
38 Morohongo Moroyama-machi Saitama-ken
TEL
049-276-1208
okada.mariko@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Okada |
Organization
Saitama Medical University
Division name
Neurology
Zip code
350-0495
Address
38 Morohongo Moroyama-machi Saitama-ken
TEL
049-276-1208
Homepage URL
okada.mariko@1972.saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38 Morohongo Moroyama-machi Saitama-ken
Tel
049-276-1111
chuoirb@saitama-med.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 31 | 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
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | 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
Observational study for three months
Management information
Registered date
| 2022 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055615
