UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018368 |
|---|---|
| Receipt number | 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 13:47:55 |
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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
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
isono-tuk@umin.ac.jp
Sponsor or person
Institute
Tsukuba University Hospital Mito Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
