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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024456
Receipt No. R000028148
Scientific Title Difference in prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function
Date of disclosure of the study information 2016/10/18
Last modified on 2016/10/18

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Basic information
Public title Difference in prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function
Acronym Difference in prevalence of H.pylori infection in hemodialysis patients
Scientific Title Difference in prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function
Scientific Title:Acronym Difference in prevalence of H.pylori infection in hemodialysis patients
Region
Japan

Condition
Condition Helicobacter pylori infection
Classification by specialty
Gastroenterology Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the prevalence of Helicobacter pylori infection in between patients with hemodialysis and normal renal function.
Basic objectives2 Others
Basic objectives -Others To compare the endoscopic finding in between patients with hemodialysis and normal renal function.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of Helicobacter pylori infection in between hemodailysis group and normal renal function group.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who received a gastrointestinal endoscopy and rapid urease test or gastric mucosal biopsy for a diagnosis of Helicobacter pylori infection at Sato Hospital, between June, 2007 and December, 2013.
Key exclusion criteria The criterion for the control group is the serum creatinine level less than 1.5 mg/dL.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Morita
Organization Gifu University Graduate School of Medicine
Division name Department of General Internal Medicine
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6632
Email hmorita@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriko Takahashi
Organization Gifu University Graduate School of Medicine
Division name Department of General Internal Medicine
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6632
Homepage URL
Email dora_bokuemonn0427@yahoo.co.jp

Sponsor
Institute Gifu University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 18 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
2016 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Performing a retrospective observational study based on the medical record information in patients who received a gastrointestinal endoscopy and rapid urease test or gastric mucosal biopsy at Sato hospital between January, 2007 and December, 2013.

Management information
Registered date
2016 Year 10 Month 18 Day
Last modified on
2016 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028148

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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