ID

17518

Beschrijving

VISN 20: Prophylactic Treatment of Interferon-Induced Depression in Hepatitis C Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00108563

Link

https://clinicaltrials.gov/show/NCT00108563

Trefwoorden

Versies (1)
  1. 20-09-16 20-09-16 -
Geüploaded op

20 september 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00108563

Engels

Eligibility Hepatitis C NCT00108563

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult male or female, age 18 or older
Beschrijving

Adult | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
planning to receive any brand of pegylated interferon/ribavirin combination therapy for chronic hcv (hepatitis c virus)
Beschrijving

pegylated interferon alfa | Ribavirin | Combined Modality Therapy Hepatitis C, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0907160
UMLS CUI [2]
C0035525
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C0524910
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
chronic liver disease other than chronic hcv
Beschrijving

Chronic liver disease | Hepatitis C, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0341439
UMLS CUI [2]
C0524910
evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy
Beschrijving

Liver disease Advanced | Ascites | Bleeding varices | Encephalopathy Spontaneous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0333106
UMLS CUI [4,1]
C0085584
UMLS CUI [4,2]
C0205359
a history of organ transplantation
Beschrijving

Organ Transplantation

Datatype

boolean

Alias
UMLS CUI [1]
C0029216
any known preexisting medical condition that could interfere with the patient's participation in the protocol, including: *active seizure disorders requiring medication; *history of major cns (central nervous system) trauma (as suggested by accident or other event leading to loss of consciousness, personality changes, etc)
Beschrijving

medical condition Pre-existing Interferes with Study Subject Participation Status | Epilepsy Requirement Pharmaceutical Preparations | Injury of central nervous system Major | Accidental event Causing Loss of consciousness | Accidental event Causing Personality change

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0014544
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0013227
UMLS CUI [3,1]
C1264238
UMLS CUI [3,2]
C0205164
UMLS CUI [4,1]
C1690974
UMLS CUI [4,2]
C0678227
UMLS CUI [4,3]
C0840361
UMLS CUI [5,1]
C1690974
UMLS CUI [5,2]
C0678227
UMLS CUI [5,3]
C0240735
any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids (e.g. oral or injection).
Beschrijving

medical condition Requirement systemic steroids chronic | Adrenal Cortex Hormones | Injection of steroid

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C2825233
UMLS CUI [1,4]
C0205191
UMLS CUI [2]
C0001617
UMLS CUI [3]
C1261311
inability to read and write at a level sufficient to complete self-report forms
Beschrijving

Able to read Insufficient | Able to write Insufficient | Patient Self-Report Completion Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0231180
UMLS CUI [2,1]
C0584993
UMLS CUI [2,2]
C0231180
UMLS CUI [3,1]
C0681906
UMLS CUI [3,2]
C0205197
UMLS CUI [3,3]
C1299582
history of significant non-compliance with medical treatments and appointments
Beschrijving

Compliance behavior Limited

Datatype

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
patients currently, or within the last three months, on a full therapeutic dose of antidepressant medication, or a dose of other medication such that it may significantly affect depressive symptomatology
Beschrijving

Antidepressive Agents Dose Full | Pharmaceutical Preparations Affecting Significant Depressive Symptoms

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003289
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0443225
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0750502
UMLS CUI [2,4]
C0086132
patients with active depression in the previous 3 months and/or those with bdi (beck depression inventory)-ii greater than or equal to 15 at the time of study entry.
Beschrijving

Depressive disorder | Beck depression inventory

Datatype

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2]
C0451022
patients with bipolar disorder or history of bipolar disorder
Beschrijving

Bipolar Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0005586
patients with active psychotic symptoms or diagnosis of schizophrenia in the previous 3 months
Beschrijving

Psychotic symptom | Schizophrenia

Datatype

boolean

Alias
UMLS CUI [1]
C0871189
UMLS CUI [2]
C0036341
active substance abuse, such as alcohol (greater than 80 gm/day), iv (intravenous) drugs, and inhaled drugs. if the patient has a history of substance abuse, in order to be considered for inclusion into the protocol, the patient must have been in a sustained remission for at least 6 months
Beschrijving

Substance Use Disorders | intravenous drug Abuse | inhaled substance Abuse | sustained remission

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0683092
UMLS CUI [2,2]
C1546935
UMLS CUI [3,1]
C0683094
UMLS CUI [3,2]
C1546935
UMLS CUI [4]
C0814128
patients receiving opiate agonist therapy (e.g., methadone maintenance therapy) within the past year, unless a program of testing for continued substance abuse is initiated (testing at entry and then randomly at least every 2-3 months) and the patient is withdrawn from study for any violation.
Beschrijving

Opiate Substitution Treatment | Drug addiction therapy - methadone

Datatype

boolean

Alias
UMLS CUI [1]
C2936530
UMLS CUI [2]
C0588202
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Similar models

Eligibility Hepatitis C NCT00108563

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult male or female, age 18 or older
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
pegylated interferon alfa | Ribavirin | Combined Modality Therapy Hepatitis C, Chronic
Item
planning to receive any brand of pegylated interferon/ribavirin combination therapy for chronic hcv (hepatitis c virus)
boolean
C0907160 (UMLS CUI [1])
C0035525 (UMLS CUI [2])
C0009429 (UMLS CUI [3,1])
C0524910 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Chronic liver disease | Hepatitis C, Chronic
Item
chronic liver disease other than chronic hcv
boolean
C0341439 (UMLS CUI [1])
C0524910 (UMLS CUI [2])
Liver disease Advanced | Ascites | Bleeding varices | Encephalopathy Spontaneous
Item
evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy
boolean
C0023895 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0003962 (UMLS CUI [2])
C0333106 (UMLS CUI [3])
C0085584 (UMLS CUI [4,1])
C0205359 (UMLS CUI [4,2])
Organ Transplantation
Item
a history of organ transplantation
boolean
C0029216 (UMLS CUI [1])
medical condition Pre-existing Interferes with Study Subject Participation Status | Epilepsy Requirement Pharmaceutical Preparations | Injury of central nervous system Major | Accidental event Causing Loss of consciousness | Accidental event Causing Personality change
Item
any known preexisting medical condition that could interfere with the patient's participation in the protocol, including: *active seizure disorders requiring medication; *history of major cns (central nervous system) trauma (as suggested by accident or other event leading to loss of consciousness, personality changes, etc)
boolean
C3843040 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0014544 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,3])
C1264238 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C1690974 (UMLS CUI [4,1])
C0678227 (UMLS CUI [4,2])
C0840361 (UMLS CUI [4,3])
C1690974 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C0240735 (UMLS CUI [5,3])
medical condition Requirement systemic steroids chronic | Adrenal Cortex Hormones | Injection of steroid
Item
any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids (e.g. oral or injection).
boolean
C3843040 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2825233 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
C0001617 (UMLS CUI [2])
C1261311 (UMLS CUI [3])
Able to read Insufficient | Able to write Insufficient | Patient Self-Report Completion Unable
Item
inability to read and write at a level sufficient to complete self-report forms
boolean
C0586740 (UMLS CUI [1,1])
C0231180 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0231180 (UMLS CUI [2,2])
C0681906 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Compliance behavior Limited
Item
history of significant non-compliance with medical treatments and appointments
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
Antidepressive Agents Dose Full | Pharmaceutical Preparations Affecting Significant Depressive Symptoms
Item
patients currently, or within the last three months, on a full therapeutic dose of antidepressant medication, or a dose of other medication such that it may significantly affect depressive symptomatology
boolean
C0003289 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443225 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0750502 (UMLS CUI [2,3])
C0086132 (UMLS CUI [2,4])
Depressive disorder | Beck depression inventory
Item
patients with active depression in the previous 3 months and/or those with bdi (beck depression inventory)-ii greater than or equal to 15 at the time of study entry.
boolean
C0011581 (UMLS CUI [1])
C0451022 (UMLS CUI [2])
Bipolar Disorder
Item
patients with bipolar disorder or history of bipolar disorder
boolean
C0005586 (UMLS CUI [1])
Psychotic symptom | Schizophrenia
Item
patients with active psychotic symptoms or diagnosis of schizophrenia in the previous 3 months
boolean
C0871189 (UMLS CUI [1])
C0036341 (UMLS CUI [2])
Substance Use Disorders | intravenous drug Abuse | inhaled substance Abuse | sustained remission
Item
active substance abuse, such as alcohol (greater than 80 gm/day), iv (intravenous) drugs, and inhaled drugs. if the patient has a history of substance abuse, in order to be considered for inclusion into the protocol, the patient must have been in a sustained remission for at least 6 months
boolean
C0038586 (UMLS CUI [1])
C0683092 (UMLS CUI [2,1])
C1546935 (UMLS CUI [2,2])
C0683094 (UMLS CUI [3,1])
C1546935 (UMLS CUI [3,2])
C0814128 (UMLS CUI [4])
Opiate Substitution Treatment | Drug addiction therapy - methadone
Item
patients receiving opiate agonist therapy (e.g., methadone maintenance therapy) within the past year, unless a program of testing for continued substance abuse is initiated (testing at entry and then randomly at least every 2-3 months) and the patient is withdrawn from study for any violation.
boolean
C2936530 (UMLS CUI [1])
C0588202 (UMLS CUI [2])
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