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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000034029 |
Receipt No. | R000038791 |
Scientific Title | Epidemiology of zoster in Miyazaki Prefecture |
Date of disclosure of the study information | 2018/09/05 |
Last modified on | 2020/03/05 |
Basic information | ||
Public title | Epidemiology of zoster in Miyazaki Prefecture | |
Acronym | Epidemiology of zoster | |
Scientific Title | Epidemiology of zoster in Miyazaki Prefecture | |
Scientific Title:Acronym | Epidemiology of zoster | |
Region |
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Condition | |||||
Condition | Herpes zoster | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Incidence including the first and second episodes of zoster and underlying diseases.
Dermatome distribution of herpes zoster. Analysis of pathogenesis of herpes zoster. Analysis of the effect of universal varicella vaccination on the epidemiology of herpes zoster. |
Basic objectives2 | Others |
Basic objectives -Others | Interval and dermatomes of the first and second episodes
Dermatome distribution in herpes zoster pathogenesis analysis from the distribution and seasonality, age, and gender, etc. of herpes zoster. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Age, gender, interval, and dermatomes of the first and second episodes
Characterization of distribution of herpes zoster Analysis of pathogenesis of herpes zoster from seasonality, age and gender, etc. |
Key secondary outcomes | The presence and absence of underlying disease(s)
Characterization of herpes zoster pathogenesis |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with herpes zoster who visited the members of the society of the Miyazaki Dermaotolist Society. Patients with herpes zoster were monitored only the first visit to the member and patients were excluded the second visit and visit from the herpes zoster pain to avoid the double counting of the number of patents with herpes zoster. | |||
Key exclusion criteria | The patient who declined to be involved in this survey. | |||
Target sample size | 200000 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Senri Kinran University | ||||||
Division name | Department of Nursing | ||||||
Zip code | |||||||
Address | 5-52-1 Fujishirodai, Suita, Osaka 565-0873, Japan | ||||||
TEL | +81-6-6872-0673 | ||||||
k-shiraki@cs.kinran.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Senri Kinran University | ||||||
Division name | Department of Nursing | ||||||
Zip code | |||||||
Address | 5-52-1 Fujishirodai, Suita, Osaka 565-0873, Japan | ||||||
TEL | +81-6-6872-0673 | ||||||
Homepage URL | |||||||
k-shiraki@cs.kinran.ac.jp |
Sponsor | |
Institute | Senri Kinran University |
Institute | |
Department |
Funding Source | |
Organization | University cost |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Miyazaki Dermatologist Society (Dr. Nozomu Toyama) |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
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Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | UMIN000034029 |
Org. issuing International ID_1 | UMIN000034029 |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Partially published |
Result | |||||||
URL related to results and publications | |||||||
Number of participants that the trial has enrolled | |||||||
Results | In October 2014, universal varicella vaccine was introduced. The relationship between varicella and herpes zoster was a mirror image. Varicella reduced and its seasonality is lost. Therefore, we are currently examining the seasonal changes in herpes zoster.
1.Toyama et al. J Dermatol Sci. 2018 92:284-286. 2.Toyama et al. J Dermatol Sci. 2018 92:89-96. 3.Shiraki et al. J Dermatol Sci. 2018 90:166-171. 4.Shiraki et al. Open Forum Infect Dis. 2017 4:ofx007. 5.Toyama et al. J Med Virol. 2009 81:2053-8. |
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Baseline Characteristics | |||||||
Participant flow | |||||||
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Outcome measures | |||||||
Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Other | |
Other related information | This epidemiological study is a continuation study of the following epidemiological study. The number of approval from the ethics committee of Senri Kinran University is "K18-003."
Title:Epidemiology of herpes zoster in Miyazaki Prefecture. UMIN registry ID: UMIN000005261 Umin receipt ID: R000006256 |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038791 |
Research Plan | |
Registered date | File name |
2018/09/24 | 千里金蘭大学「疫学研究実施計画審査申請書」修正版.doc |
Research case data specifications | |
Registered date | File name |
Research case data | |
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