UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017356 |
|---|---|
| Receipt number | R000020143 |
| Scientific Title | The association of Helicobacter pylori infection in NTG patient |
| Date of disclosure of the study information | 2015/04/30 |
| Last modified on | 2019/11/02 09:40:35 |
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Basic information
Public title
The association of Helicobacter pylori infection in NTG patient
Acronym
The association of Helicobacter pylori infection in NTG patient
Scientific Title
The association of Helicobacter pylori infection in NTG patient
Scientific Title:Acronym
The association of Helicobacter pylori infection in NTG patient
Region
| Japan |
Condition
Condition
normal tension glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The association of Helicobacter pylori infection in NTG patient
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to investigate the association between a systemic oxidative stress biomarker, 8-hydroxy-2-deoxyguanosine, and AGE in patients with normal-tension glaucoma and in healthy controls.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The association of Helicobacter pylori infection in NTG patient and control group.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All subjects with NTG underwent a complete ophthalmic examination, including best corrected visual acuity measurement, slit lamp biomicroscopy, Goldman applanation tonometry, gonioscopy, funduscopy, automated perimetry with the HFA, and optic disc evaluation with a 90-diopter lens by a glaucoma specialist.
Key exclusion criteria
Subjects were excluded if they had other ophthalmic conditions, such as angle-closure glaucoma, pigment dispersion glaucoma, exfoliative glaucoma, trauma, any other type of secondary glaucoma, high myopia (exceeding -8D or hyperopia above +3D), or were below 50 or over 60 years of age.
Target sample size
152
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Nakazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
TEL
0227177294
ntoru@oph.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Himori |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
980-8574
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Miyagi-ken 980-8574, Japan
TEL
0227177294
Homepage URL
n-himori@oph.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine
Department of Ophthalmology
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
none
Address
none
Tel
none
none
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 30 | 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
| 2013 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study of searching
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2019 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020143
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
