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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042192
Receipt No. R000048153
Scientific Title Registry study on development of new diagnostic, novel treatment and prevention measures of neurological diseases
Date of disclosure of the study information 2020/11/18
Last modified on 2020/11/11

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Basic information
Public title Registry study on development of new diagnostic, novel treatment and prevention measures of neurological diseases
Acronym Neurological diseases registry
Scientific Title Registry study on development of new diagnostic, novel treatment and prevention measures of neurological diseases
Scientific Title:Acronym Neurological diseases registry
Region
Japan

Condition
Condition Neurological diseases
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We aim to accumulate clinical information and biological sample of patients with neurological diseases and to examine evaluation items on a sustainable as well as long-standing neurological diseases registry. We also aim to clarify natural history and prognostic factors to develop new diagnostic, novel treatment and prevention measures of neurological diseases.
Basic objectives2 Others
Basic objectives -Others Registry study (Prospective cohort study, Retrospective cohort study, Cross-sectional study)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mortality
Severity classification
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Stroke, Neuroimmune disease, Infectious diseases of the nervous system, Functional neurological disorder, Neurodegenerative disease, Other neurological diseases

1) Patients who were diagnosed with the above diseases
2)Patients signed the informed consent document
Key exclusion criteria Patients judged inappropriate for this study as judged by the investigator.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Yoshihisa
Middle name
Last name Yamano
Organization St. Marianna University School of Medicine
Division name Department of Neurology
Zip code 216-8511
Address Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan
TEL 044-977-8111
Email yyamano@marianna-u.ac.jp

Public contact
Name of contact person
1st name Yoshihisa
Middle name
Last name Yamano
Organization St. Marianna University School of Medicine
Division name Department of Neurology
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL 044-977-8111
Homepage URL
Email yyamano@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Department of Neurology
Institute
Department

Funding Source
Organization St. Marianna University School of 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 St. Marianna University School of Medicine, Ethics Committee
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
Tel 0449778111
Email k-sienbu.mail@marianna-u.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
2020 Year 11 Month 18 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 Preinitiation
Date of protocol fixation
2020 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 30 Day
Last follow-up date
2040 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Registry study

Management information
Registered date
2020 Year 10 Month 21 Day
Last modified on
2020 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048153

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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