UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031052 |
|---|---|
| Receipt number | R000035453 |
| Scientific Title | A prospective randomized control study for chest radiographs |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2020/08/04 10:33:04 |
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Basic information
Public title
A prospective randomized control study for chest radiographs
Acronym
A randomized control study for chest radiographs
Scientific Title
A prospective randomized control study for chest radiographs
Scientific Title:Acronym
A randomized control study for chest radiographs
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine how to take an effective chest X- ray
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accuracy of chest X-p each time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To use a device at the timing of chest X-p
Interventions/Control_2
Not to use a device at the timing of chest X-p(control)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who needed to take chest X-p at outpatient department
Key exclusion criteria
(1)patients who aspirate a foreign body
(2)patients who need for emergency treatment
(3)patients who has diseases of bone, diaphragm, lateral curvature or thoracic deformity
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | SUGIURA |
Organization
National Center for Global Health and Medicine
Division name
Bureau of International Health Cooperation
Zip code
162-8655
Address
1-21-1 Toyama, Shinjyuku-ku, Tokyo
TEL
03-3202-7181
yasugiura@it.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | SUGIURA |
Organization
National Center for Global Health and Medicine
Division name
Bureau of International Health Cooperation
Zip code
162-8655
Address
1-21-1 Toyama, Shinjyuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
yasugiura@it.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and 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
National Center for Global Health and Medicine
Address
1-2-1 Toyama, Shinjyuku-ku Tokyo Japan
Tel
03-3202-7181
yasugiura@it.ncgm.go.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
国立国際医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 01 | 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
124
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
Main results already published
Date of protocol fixation
| 2017 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 08 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 20 | Day |
Other
Other related information
The result of this research was published in the journal as follows;
Biosci Trends
. 2020 Jul 17;14(3):200-205. doi: 10.5582/bst.2020.03024. Epub 2020 May 17.
A breathing movement sensor for chest radiography during inspiration in children aged less than 3 years: a prospective randomized controlled study
Management information
Registered date
| 2018 | Year | 01 | Month | 29 | Day |
Last modified on
| 2020 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035453
