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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036632
Receipt No. R000041734
Scientific Title Evaluation of stroop test for the diagnosis of minimal hepatic encephalopathy: a prospective study
Date of disclosure of the study information 2019/05/01
Last modified on 2019/04/30

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Basic information
Public title Evaluation of stroop test for the diagnosis of minimal hepatic encephalopathy: a prospective study
Acronym Evaluation of stroop test for the diagnosis of minimal hepatic encephalopathy: a prospective study
Scientific Title Evaluation of stroop test for the diagnosis of minimal hepatic encephalopathy: a prospective study
Scientific Title:Acronym Evaluation of stroop test for the diagnosis of minimal hepatic encephalopathy: a prospective study
Region
Japan

Condition
Condition cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of stroop test for the diagnosis of minimal hepatic encephalopathy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To establish the optimal cut-off value to diagnose minimal hepatic encephalopathy
Key secondary outcomes overt hepatic encephalopathy, prognosis, sarcopenia, osteoporosis, or fracture

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
80 years-old >
Gender Male and Female
Key inclusion criteria patients with cirrhosis
patients who are able to provide written informed consent
Key exclusion criteria Presence of overt hepatic encephalopathy or history of OHE in the past 4 weeks; Achromatopsia; Presence of uncontrolled hepatocellular carcinoma or other malignancies; Previous transjugular intrahepatic portosystemic shunt or shunt surgery; Active ongoing infection; History of gastrointestinal bleeding, infection or spontaneous bacterial peritonitis in the past 4 weeks; Drug or alcohol abuse in the past 4 weeks; Use of benzodiazepines, anti-epileptic or psychotropic drugs; Presence of neurological diseases; Pregnancy; Presence of severe comorbidities such as heart, respiratory, and/or renal failure
Target sample size 200

Research contact person
Name of lead principal investigator
1st name makoto
Middle name
Last name shiraki
Organization Gifu University Graduate School of Medicine
Division name Department of Gastroenterology/Internal Medicine
Zip code 5011194
Address yanagido 1-1, gifu
TEL 058-230-6308
Email mshiraki-gif@umin.ac.jp

Public contact
Name of contact person
1st name tatsunori
Middle name
Last name hanai
Organization Gifu University Graduate School of Medicine
Division name Department of Gastroenterology/Internal Medicine
Zip code 5011194
Address yanagido 1-1, gifu
TEL 058-230-6308
Homepage URL
Email hanai@gifu-u.ac.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 the ethics committee of Gifu University Graduate School of Medicine
Address Yanagido 1-1 Gifu 501-1194
Tel 0582306059
Email rinri@gifu-u.ac.jp

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
2019 Year 05 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
2019 Year 01 Month 09 Day
Date of IRB
2019 Year 03 Month 11 Day
Anticipated trial start date
2019 Year 03 Month 11 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2019 Year 04 Month 30 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041734

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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