UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014786 |
|---|---|
| Receipt number | R000017187 |
| Scientific Title | Survey of Acute mountain sickness with Lake Louise Symptom Score |
| Date of disclosure of the study information | 2014/08/07 |
| Last modified on | 2020/02/10 11:29:35 |
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Basic information
Public title
Survey of Acute mountain sickness with Lake Louise Symptom Score
Acronym
Survey of Acute mountain sickness with Lake Louise Symptom Score
Scientific Title
Survey of Acute mountain sickness with Lake Louise Symptom Score
Scientific Title:Acronym
Survey of Acute mountain sickness with Lake Louise Symptom Score
Region
| Japan |
Condition
Condition
Acute mountain sickness
Classification by specialty
| Medicine in general | Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know the occurrence of acute mountain sickness among Japanese tourrists to high altitude areas
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
occurrence of acute mountain sickness among Japanese tourrists to high altitude areas
Key secondary outcomes
Risk factor of acute mountain sickness among Japanese tourrists to high altitude areas
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
People who visit Travellers' Medical Center before staying in high altitude areas
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Fukushima |
Organization
Tokyo Medical University Hospital
Division name
Travellers' Medical Center
Zip code
Address
6-7-1 Nishishinjuku, Shinjukuku, Tokyo
TEL
03-3342-6111
fuku789@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Fukushima |
Organization
Tokyo Medical University Hospital
Division name
Travellers' Medical Center
Zip code
Address
6-7-1 Nishishinjuku, Shinjukuku, Tokyo
TEL
03-3342-6111
Homepage URL
http://hospinfo.tokyo-med.ac.jp/shinryo/tokou/index.html
fuku789@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
東京医科大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 07 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study based on the questionnaire
Lake Louise Symptom Score(LLSS) self-report-questionnaire
Management information
Registered date
| 2014 | Year | 08 | Month | 07 | Day |
Last modified on
| 2020 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017187
