ID

20964

Description

Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00227149

Link

https://clinicaltrials.gov/show/NCT00227149

Keywords

Versions (2)
  1. 3/31/17 3/31/17 -
  2. 3/31/17 3/31/17 -
Uploaded on

March 31, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT00227149

English

Eligibility Hepatitis C, Chronic NCT00227149

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with chronic hepatitis c and indication for interferon-based antiviral therapy.
Description

Hepatitis C, Chronic | Indication Antiviral Therapy | Interferon

Data type

boolean

Alias
UMLS CUI [1]
C0524910
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0280274
UMLS CUI [3]
C3652465
written informed consent to study participation, especially to long-term follow-up monitoring of psychiatric and neurocognitive side effects of combination therapy with (peg)interferon alfa-2b and ribavirin.
Description

Informed Consent | Clinical Study Follow-up | Adverse effects Psychiatric Long-term | Adverse effects neurocognitive Long-term | Combined Modality Therapy | Interferon Alfa-2b | Ribavirin

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C3274571
UMLS CUI [3,1]
C0879626
UMLS CUI [3,2]
C0205487
UMLS CUI [3,3]
C0443252
UMLS CUI [4,1]
C0879626
UMLS CUI [4,2]
C0518895
UMLS CUI [4,3]
C0443252
UMLS CUI [5]
C0009429
UMLS CUI [6]
C0021735
UMLS CUI [7]
C0035525
age of study participants: between 18 and 65 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
all patients need to have documented antibodies to hepatitis c virus (hcv) and circulating hcv-rna as measured by reverse-transcription polymerase chain reaction (cobas amplicor hcv monitor™ test, roche diagnostics)
Description

Hepatitis C Antibodies | HCV viral load Circulating | Reverse Transcriptase Polymerase Chain Reaction

Data type

boolean

Alias
UMLS CUI [1]
C0166049
UMLS CUI [2,1]
C1868902
UMLS CUI [2,2]
C0175630
UMLS CUI [3]
C0599161
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
insufficient knowledge of the german language or cognitive impairment (due to the indispensable application of questionnaires and the tap, test battery of attentional performance).
Description

Insufficient knowledge German language | Impaired cognition | Questionnaires Comprehension

Data type

boolean

Alias
UMLS CUI [1,1]
C4062254
UMLS CUI [1,2]
C0017477
UMLS CUI [2]
C0338656
UMLS CUI [3,1]
C0034394
UMLS CUI [3,2]
C0162340
further exclusion criteria:
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
age under 18 years or over 65 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
coinfections such as hepatitis b virus or human immunodeficiency virus
Description

HBV coinfection | HIV coinfection

Data type

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
severe internal diseases (e.g., cancer, ischemic heart disease, autoimmune disease)
Description

Disease Internal Severe | Malignant Neoplasms | Myocardial Ischemia | Autoimmune Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205102
UMLS CUI [1,3]
C0205082
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0151744
UMLS CUI [4]
C0004364
major depressive disorder (according to the diagnostic and statistical manual of mental disorders, fourth edition [dsm-iv] criteria), psychosis, active intravenous drug use or alcohol abuse.
Description

Major Depressive Disorder | Psychotic Disorders | intravenous drug use | Alcohol abuse

Data type

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0699778
UMLS CUI [4]
C0085762
these additional exclusion criteria are important in order to avoid interfering or confounding effects by other variables that are not linked to the hepatitis c infection.
Description

Confounding variables Exclusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0009673
UMLS CUI [1,2]
C2828389
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Similar models

Eligibility Hepatitis C, Chronic NCT00227149

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C, Chronic | Indication Antiviral Therapy | Interferon
Item
patients with chronic hepatitis c and indication for interferon-based antiviral therapy.
boolean
C0524910 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0280274 (UMLS CUI [2,2])
C3652465 (UMLS CUI [3])
Informed Consent | Clinical Study Follow-up | Adverse effects Psychiatric Long-term | Adverse effects neurocognitive Long-term | Combined Modality Therapy | Interferon Alfa-2b | Ribavirin
Item
written informed consent to study participation, especially to long-term follow-up monitoring of psychiatric and neurocognitive side effects of combination therapy with (peg)interferon alfa-2b and ribavirin.
boolean
C0021430 (UMLS CUI [1])
C3274571 (UMLS CUI [2])
C0879626 (UMLS CUI [3,1])
C0205487 (UMLS CUI [3,2])
C0443252 (UMLS CUI [3,3])
C0879626 (UMLS CUI [4,1])
C0518895 (UMLS CUI [4,2])
C0443252 (UMLS CUI [4,3])
C0009429 (UMLS CUI [5])
C0021735 (UMLS CUI [6])
C0035525 (UMLS CUI [7])
Age
Item
age of study participants: between 18 and 65 years.
boolean
C0001779 (UMLS CUI [1])
Hepatitis C Antibodies | HCV viral load Circulating | Reverse Transcriptase Polymerase Chain Reaction
Item
all patients need to have documented antibodies to hepatitis c virus (hcv) and circulating hcv-rna as measured by reverse-transcription polymerase chain reaction (cobas amplicor hcv monitor™ test, roche diagnostics)
boolean
C0166049 (UMLS CUI [1])
C1868902 (UMLS CUI [2,1])
C0175630 (UMLS CUI [2,2])
C0599161 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Insufficient knowledge German language | Impaired cognition | Questionnaires Comprehension
Item
insufficient knowledge of the german language or cognitive impairment (due to the indispensable application of questionnaires and the tap, test battery of attentional performance).
boolean
C4062254 (UMLS CUI [1,1])
C0017477 (UMLS CUI [1,2])
C0338656 (UMLS CUI [2])
C0034394 (UMLS CUI [3,1])
C0162340 (UMLS CUI [3,2])
Exclusion Criteria Additional
Item
further exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Age
Item
age under 18 years or over 65 years
boolean
C0001779 (UMLS CUI [1])
HBV coinfection | HIV coinfection
Item
coinfections such as hepatitis b virus or human immunodeficiency virus
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Disease Internal Severe | Malignant Neoplasms | Myocardial Ischemia | Autoimmune Diseases
Item
severe internal diseases (e.g., cancer, ischemic heart disease, autoimmune disease)
boolean
C0012634 (UMLS CUI [1,1])
C0205102 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2])
C0151744 (UMLS CUI [3])
C0004364 (UMLS CUI [4])
Major Depressive Disorder | Psychotic Disorders | intravenous drug use | Alcohol abuse
Item
major depressive disorder (according to the diagnostic and statistical manual of mental disorders, fourth edition [dsm-iv] criteria), psychosis, active intravenous drug use or alcohol abuse.
boolean
C1269683 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0699778 (UMLS CUI [3])
C0085762 (UMLS CUI [4])
Confounding variables Exclusion
Item
these additional exclusion criteria are important in order to avoid interfering or confounding effects by other variables that are not linked to the hepatitis c infection.
boolean
C0009673 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
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