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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018368
Receipt No. R000021268
Scientific Title Crowned dens syndrome: multicenter retrospective case series
Date of disclosure of the study information 2015/08/01
Last modified on 2016/08/29

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Basic information
Public title Crowned dens syndrome: multicenter retrospective case series
Acronym Crowned dens syndrome: multicenter retrospective case series
Scientific Title Crowned dens syndrome: multicenter retrospective case series
Scientific Title:Acronym Crowned dens syndrome: multicenter retrospective case series
Region
Japan

Condition
Condition Crowned dens syndrome (CDS)
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to report our experience with and describe the clinical features of crowned dens syndrome in Japan.
Basic objectives2 Others
Basic objectives -Others Clinical feature
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of the crowned dens syndrome (CDS); Proportion of the patients who were diagnosed with CDS within one day; and Clinical features of CDS
Key secondary outcomes Time required for resolution; Causes of delayed diagnosis; Features of cases in which lumbar puncture was performed; Features of inpatient cases; and Features of misdiagnosed cases

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

Not applicable
Gender Male and Female
Key inclusion criteria Adult patients who had neck pain and in whom radiography revealed calcifications around the dens.
Key exclusion criteria No diagnosis of CDS in the medical records.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Isono
Organization Tsukuba University Hospital Mito Medical Center
Division name General internal medicine
Zip code
Address 3-2-7 Miyamachi, Mito, Ibaraki 310-0015, Japan.
TEL 029-231-2371
Email isono-tuk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Isono
Organization Tsukuba University Hospital Mito Medical Center
Division name General internal medicine
Zip code
Address 3-2-7 Miyamachi, Mito, Ibaraki 310-0015, Japan.
TEL 029-231-2371
Homepage URL
Email isono-tuk@umin.ac.jp

Sponsor
Institute Tsukuba University Hospital Mito Medical Center
Institute
Department

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
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 水戸協同病院(茨城県) Tsukuba University Hospital Mito Medical Center(Ibaraki)
湘南鎌倉総合病院(神奈川県) Shonankamakura General Hospital(Kanagawa)
明石医療センター(兵庫県) Akashi Medical Center (Hyogo)
練馬光が丘病院(東京都)  Nerima Hikarigaoka Hospital(Tokyo)
東京ベイ浦安市川医療センター(千葉県) Tokyobay UrayasuIchikawa Medical Center(Chiba)
飯塚病院(福岡県) Aso Iizuka Hospital (Fukuoka)
筑波メディカルセンター病院(茨城県) Tsukuba Medical Center Hospital (Ibaraki)
亀田総合病院(千葉県) Kameda Medical Center (Chiba)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2015 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2016 Year 12 Month 30 Day

Other
Other related information Retrospective study

Management information
Registered date
2015 Year 07 Month 21 Day
Last modified on
2016 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021268

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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