ID

22219

Beschreibung

HEPMET-1: Evaluate the Feasibility, Mental Sideeffects and the Efficacy of Hepatitis C Treatment in a MMT Group.; ODM derived from: https://clinicaltrials.gov/show/NCT00147784

Link

https://clinicaltrials.gov/show/NCT00147784

Stichworte

Versionen (1)
  1. 23.05.17 23.05.17 -
Hochgeladen am

23. Mai 2017

DOI

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Creative Commons BY 4.0
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Eligibility Opiate Dependence NCT00147784

Englisch

Eligibility Opiate Dependence NCT00147784

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
serologic evidence of hepatitis c infection, genotype 2 and 3
Beschreibung

Hepatitis C Genotype Evidence Serologic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C1148363
UMLS CUI [1,3]
C3887511
UMLS CUI [1,4]
C0205473
normal or elevated serum alt activity
Beschreibung

ALT serum level normal | ALT level raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0580468
UMLS CUI [2]
C1443982
in mmt-programme and with at least 6 months with satisfactory drug abuse control. that means no iv injections and no or minimal use of drugs.
Beschreibung

Drug addiction therapy - methadone | Drug abuse control Satisfactory | Intravenous Injections Absent | Drug use Absent | Drug use Minimal

Datentyp

boolean

Alias
UMLS CUI [1]
C0588202
UMLS CUI [2,1]
C1171189
UMLS CUI [2,2]
C0205410
UMLS CUI [3,1]
C0021494
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0242510
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0242510
UMLS CUI [5,2]
C0547040
male and female patients
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women with ongoing pregnancy or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
untreated serious psychiatric disorders, particularly depression.
Beschreibung

Mental disorders Serious Untreated | Depressive disorder Serious Untreated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332155
serious drug abuse or alcohol abuse last 6 months
Beschreibung

Substance Use Disorders Serious

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0205404
intravenous drug abuse last 6 months
Beschreibung

Intravenous Drug Abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0086181
hepatitis a, b or hiv infection
Beschreibung

Hepatitis A | Hepatitis B | HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0019159
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019693
hcv genotype 1, 4, 5 and 6
Beschreibung

Hepatitis C virus genotype

Datentyp

boolean

Alias
UMLS CUI [1]
C1148363
leucocytes < 3000 cells/mm3 at screening (neutrophil count <1500 cells/mm3)
Beschreibung

White Blood Cell Count procedure | Neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0200633
platelet count < 80 000 cells/mm3 at screening
Beschreibung

Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0032181
hb <11 g/dl in women or <12 g/dl in men at screening
Beschreibung

Hemoglobin measurement | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
documented or presumed coronary artery disease or cerebrovascular disease
Beschreibung

Coronary Artery Disease | Coronary Artery Disease Suspected | Cerebrovascular Disorder | Cerebrovascular Disorder Suspected

Datentyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0007820
UMLS CUI [4,1]
C0007820
UMLS CUI [4,2]
C0750491
thyroid dysfunction not adequately controlled
Beschreibung

Thyroid dysfunction Poorly controlled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348024
UMLS CUI [1,2]
C3853134
epilepsy
Beschreibung

Epilepsy

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
malignant disease
Beschreibung

Malignant Neoplasm

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
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Ähnliche Modelle

Eligibility Opiate Dependence NCT00147784

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Hepatitis C Genotype Evidence Serologic
Item
serologic evidence of hepatitis c infection, genotype 2 and 3
boolean
C0019196 (UMLS CUI [1,1])
C1148363 (UMLS CUI [1,2])
C3887511 (UMLS CUI [1,3])
C0205473 (UMLS CUI [1,4])
ALT serum level normal | ALT level raised
Item
normal or elevated serum alt activity
boolean
C0580468 (UMLS CUI [1])
C1443982 (UMLS CUI [2])
Drug addiction therapy - methadone | Drug abuse control Satisfactory | Intravenous Injections Absent | Drug use Absent | Drug use Minimal
Item
in mmt-programme and with at least 6 months with satisfactory drug abuse control. that means no iv injections and no or minimal use of drugs.
boolean
C0588202 (UMLS CUI [1])
C1171189 (UMLS CUI [2,1])
C0205410 (UMLS CUI [2,2])
C0021494 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0242510 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0242510 (UMLS CUI [5,1])
C0547040 (UMLS CUI [5,2])
Gender
Item
male and female patients
boolean
C0079399 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
women with ongoing pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Mental disorders Serious Untreated | Depressive disorder Serious Untreated
Item
untreated serious psychiatric disorders, particularly depression.
boolean
C0004936 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0011581 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
Substance Use Disorders Serious
Item
serious drug abuse or alcohol abuse last 6 months
boolean
C0038586 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Intravenous Drug Abuse
Item
intravenous drug abuse last 6 months
boolean
C0086181 (UMLS CUI [1])
Hepatitis A | Hepatitis B | HIV Infection
Item
hepatitis a, b or hiv infection
boolean
C0019159 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Hepatitis C virus genotype
Item
hcv genotype 1, 4, 5 and 6
boolean
C1148363 (UMLS CUI [1])
White Blood Cell Count procedure | Neutrophil count
Item
leucocytes < 3000 cells/mm3 at screening (neutrophil count <1500 cells/mm3)
boolean
C0023508 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
Platelet Count measurement
Item
platelet count < 80 000 cells/mm3 at screening
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement | Gender
Item
hb <11 g/dl in women or <12 g/dl in men at screening
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Coronary Artery Disease | Coronary Artery Disease Suspected | Cerebrovascular Disorder | Cerebrovascular Disorder Suspected
Item
documented or presumed coronary artery disease or cerebrovascular disease
boolean
C1956346 (UMLS CUI [1])
C1956346 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0007820 (UMLS CUI [3])
C0007820 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
Thyroid dysfunction Poorly controlled
Item
thyroid dysfunction not adequately controlled
boolean
C0348024 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Epilepsy
Item
epilepsy
boolean
C0014544 (UMLS CUI [1])
Malignant Neoplasm
Item
malignant disease
boolean
C0006826 (UMLS CUI [1])
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