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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023971
Receipt No. R000024966
Scientific Title Disturbance of autonomic nervous function in the severe cases of intracranial hypotension
Date of disclosure of the study information 2016/09/08
Last modified on 2019/03/27

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Basic information
Public title Disturbance of autonomic nervous function in the severe cases of intracranial hypotension
Acronym Disturbance of autonomic nervous function in the severe cases of intracranial hypotension
Scientific Title Disturbance of autonomic nervous function in the severe cases of intracranial hypotension
Scientific Title:Acronym Disturbance of autonomic nervous function in the severe cases of intracranial hypotension
Region
Japan

Condition
Condition intracranial hypotension
Classification by specialty
Medicine in general Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the autonomic nervous function in the severe cases of intracranial hypotension
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes autonomic nervous function
anti-acetylcholine receptor antibody
transferrin
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
80 years-old >=
Gender Male and Female
Key inclusion criteria intraclanial hypotension
Key exclusion criteria traffic accident
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Nobuo
Middle name
Last name Araki
Organization Saitama Medical University Faculty of medicine
Division name Department of Neurology
Zip code 350-0495
Address 38 Morohongou Moroyama Saitama
TEL 049-276-1209
Email yokkan3@saitama-med.ac.jp

Public contact
Name of contact person
1st name Makiko
Middle name
Last name Hirayama
Organization Saitama Medical University Faculty of Medicine
Division name Department of Neurology
Zip code 350-0495
Address 38 Morohongou Moroyama Saitama
TEL 049-276-1209
Homepage URL
Email csfh@saitama-med.ac.jp

Sponsor
Institute Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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 Saitama Medical University Hospital Institutional Review Board
Address 38 Morohongo Moroyama-machi Iruma-gun Saitama
Tel 049-276-1354
Email hirb@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 埼玉医科大学病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 08 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 23
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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 09 Month 05 Day
Anticipated trial start date
2016 Year 09 Month 07 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 06 Month 30 Day
Date trial data considered complete
2019 Year 06 Month 30 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information We will observe the patients who suffer from lumber puncture examinations

Management information
Registered date
2016 Year 09 Month 07 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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