Minimal HePatic Encephalopathy Among CiRrhotics. A Cross SEctional, Clinico-EpidEmiological, Multi-Centre, Study in Patients of PakisTan

NCT ID: NCT02613858

Last Updated: 2017-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-05-31

Brief Summary

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The Preempt study is likely to help determine the frequency of patients suffering from Minimal Hepatic Encephalopathy (MHE) and are cirrhotics. It will also enable us to know about the Quality of life of these patients.

Detailed Description

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Conditions

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Hepatic Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients of either sex, 18-65 years of age, who have attended school at least till the 5th Class/Standard having an established diagnosis of liver cirrhosis without any overt symptoms at time of testing with Grade 0 of West Haven criteria.
* Patients willing to undergo the neuropsychological (NP) tests and to complete the SF-36 questionnaire for the estimation of Health Related Quality of Life (HRQOL).
* Patients willing to provide written authorization to provide data for the study.

Exclusion Criteria

* Patients with inability to perform neuropsychometric tests and to complete the SF-36 questionnaire as decided by the physician.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dimension Research

INDUSTRY

Sponsor Role collaborator

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raeefuddin Ahmed, MD

Role: STUDY_DIRECTOR

Medical Director, Abbott

Locations

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Baqai Hospital

Karachi, , Pakistan

Site Status

Fatima Memorial Hospital

Lahore, , Pakistan

Site Status

Lahore General Hospital

Lahore, , Pakistan

Site Status

Jinnah Hospital Lahore

Lahore, , Pakistan

Site Status

Doctor's Hospital

Lahore, , Pakistan

Site Status

Lady Reading Hospital

Peshawar, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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EPIDI038

Identifier Type: -

Identifier Source: org_study_id

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