UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018030 |
|---|---|
| Receipt number | R000020888 |
| Scientific Title | Risk of aspiration pneumonia in Progressive supra nuclear palsy, retrospective cohort study |
| Date of disclosure of the study information | 2015/06/23 |
| Last modified on | 2015/06/28 17:14:59 |
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Basic information
Public title
Risk of aspiration pneumonia in Progressive supra nuclear palsy, retrospective cohort study
Acronym
Aspiration pneumonia in Progressive supranuclear palsy
Scientific Title
Risk of aspiration pneumonia in Progressive supra nuclear palsy, retrospective cohort study
Scientific Title:Acronym
Aspiration pneumonia in Progressive supranuclear palsy
Region
| Japan |
Condition
Condition
progressive supranuclear palsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prognostic factors and clinical consequences of pneumonia in PSP
Basic objectives2
Others
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
latency to the initial development of pneumonia
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
consecutive patients with PSP who were followed in the Utano National Hospital Parkinson Disease Center between November 2006 and December 2014, and fulfilled clinical criteria for a probable or possible PSP diagnosis according to the PSP criteria of the National Institute of Neurological Disorders and Stroke and the society for PSP (NINDS-SPSP)
Key exclusion criteria
Patients observed for less than 2 years from the initial symptoms and signs
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Sawada |
Organization
Utano National Hospital
Division name
Clinical Research Center
Zip code
Address
8 Ondoyamacho, Narutaki, Ukyoku, Kyoto
TEL
81-75-461-5121
sawada@unh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Sawada |
Organization
Utano National Hospital
Division name
Clinical Research Center
Zip code
Address
8 Ondoyamacho, Narutaki, Ukyoku, Kyoto
TEL
81-75-461-5121
Homepage URL
sawada@unh.hosp.go.jp
Sponsor or person
Institute
Utano National Hospital
Institute
Department
Personal name
Funding Source
Organization
Clinical Research Center, Utano National Hospital
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 23 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Under review
Management information
Registered date
| 2015 | Year | 06 | Month | 22 | Day |
Last modified on
| 2015 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020888
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2015/06/28 | Utano_PSP_Study_database_for_UMIN-ICDR.xlsx |
