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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018031
Receipt No. R000020889
Scientific Title Systemic inflammation and motor prognosis in Parkinson disease: a retrospective study
Date of disclosure of the study information 2015/06/22
Last modified on 2015/06/29

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Basic information
Public title Systemic inflammation and motor prognosis in Parkinson disease: a retrospective study
Acronym Inflammation-PD study
Scientific Title Systemic inflammation and motor prognosis in Parkinson disease: a retrospective study
Scientific Title:Acronym Inflammation-PD study
Region
Japan

Condition
Condition Parkinson disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the longitudinal effect of the baseline CRP concentrations on motor prognosis of Parkinson disease (PD).
Basic objectives2 Others
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome measure was the change of the Unified PD Rating Scale Part III scores (on period) from the study enrollment to each of the five follow-up periods (the Day 1-90, 91-270, 271-450, 451-630, and 631-900).
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 Patients with PD who fulfilled the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria (steps 1 and 2), who were admitted to the Department of Neurology of National Regional Center for Neurological Disorders and National Hospital of Utano between January 2008 and December 2013. Subjects with both of the following conditions were included. (i) Plasma concentrations of high-sensitivity CRP for screening blood test were measured in the period when patients were not diagnosed as having any infections. (ii) Modified Hoehn and Yahr stage 4 or less at baseline.
Key exclusion criteria Subjects with any of the following conditions were excluded. (i) Patients who developed dementia within 1 year of the onset of parkinsonism based on consideration of dementia with Lewy bodies (1-year rule).23 (ii) History of brain surgery. (iii) Having any infections within the one month prior to the enrollment. (iv) Concomitant chronic inflammatory diseases including autoimmune diseases or malignancy. (v) Taking corticosteroids.
Target sample size 192

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
Email 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
Email sawada@unh.hosp.go.jp

Sponsor
Institute Utano National Hospital
Institute
Department

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
Email

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 22 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
2014 Year 09 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 20 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 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020889

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2015/06/29 PD_crp data set.xlsx


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