ID

44043

Beschreibung

Double Filtration Plasmapheresis for Hepatitis C Virus (HCV) Genotype 1 Patients With High Viral Load; ODM derived from: https://clinicaltrials.gov/show/NCT00977054

Link

https://clinicaltrials.gov/show/NCT00977054

Stichworte

Versionen (3)
  1. 15.04.18 15.04.18 -
  2. 16.04.18 16.04.18 -
  3. 20.09.21 20.09.21 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00977054

Englisch

Eligibility Hepatitis C NCT00977054

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
treatment naïve
Beschreibung

Therapy naive

Datentyp

boolean

Alias
UMLS CUI [1]
C0919936
age 18 and older
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
anti-hcv (abbott hcv eia 2.0, abbott diagnostic, chicago, il) positive > 6 months
Beschreibung

Hepatitis C antibody positive

Datentyp

boolean

Alias
UMLS CUI [1]
C0281863
detectable serum quantitative hcv-rna (cobas taqman v2.0, roche diagnostics) with hcv rna > 800,000 iu/ml
Beschreibung

Serum hepatitis c viral rna quantitative Detectable | HCV RNA

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4272238
UMLS CUI [1,2]
C3830527
UMLS CUI [2]
C0369335
hcv genotype 1 (inno-lipa, innogenetics)
Beschreibung

Hepatitis C virus genotype determination

Datentyp

boolean

Alias
UMLS CUI [1]
C1533728
a liver biopsy consistent with the diagnosis of chronic hepatitis c
Beschreibung

Biopsy of liver Consistent with Chronic Hepatitis C

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0193388
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
Beschreibung

Anemia | Hemoglobin measurement | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0079399
neutropenia (neutrophil count <1,500 per cubic milliliter)
Beschreibung

Neutropenia | Neutrophil count

Datentyp

boolean

Alias
UMLS CUI [1]
C0027947
UMLS CUI [2]
C0200633
thrombocytopenia (platelet <90,000 per cubic milliliter)
Beschreibung

Thrombocytopenia | Platelet Count measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
Beschreibung

HBV coinfection | HIV coinfection

Datentyp

boolean

Alias
UMLS CUI [1]
C2242656
UMLS CUI [2]
C4062778
chronic alcohol abuse (daily consumption > 20 gram per day)
Beschreibung

Alcoholic Intoxication, Chronic | Alcohol consumption Gram per day

Datentyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0439417
decompensated liver disease (child-pugh class b or c)
Beschreibung

Decompensated liver disease Child-Pugh Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4075847
UMLS CUI [1,2]
C4050412
serum creatinine level more than 1.5 times the upper limit of normal
Beschreibung

Serum creatinine raised

Datentyp

boolean

Alias
UMLS CUI [1]
C0700225
autoimmune liver disease
Beschreibung

Autoimmune liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0400936
neoplastic disease
Beschreibung

Neoplastic disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1882062
an organ transplant
Beschreibung

Organ Transplantation

Datentyp

boolean

Alias
UMLS CUI [1]
C0029216
immunosuppressive therapy
Beschreibung

Therapeutic immunosuppression

Datentyp

boolean

Alias
UMLS CUI [1]
C0021079
poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
Beschreibung

Autoimmune Diseases Poorly controlled | Lung diseases Poorly controlled | Heart Diseases Poorly controlled | Mental disorders Poorly controlled | Nervous system disorder Poorly controlled | Poorly controlled diabetes mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C3853134
UMLS CUI [3,1]
C0018799
UMLS CUI [3,2]
C3853134
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C3853134
UMLS CUI [5,1]
C0027765
UMLS CUI [5,2]
C3853134
UMLS CUI [6]
C0554876
evidence of drug abuse
Beschreibung

Drug abuse

Datentyp

boolean

Alias
UMLS CUI [1]
C0013146
unwilling to have contraception
Beschreibung

Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hepatitis C NCT00977054

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Therapy naive
Item
treatment naïve
boolean
C0919936 (UMLS CUI [1])
Age
Item
age 18 and older
boolean
C0001779 (UMLS CUI [1])
Hepatitis C antibody positive
Item
anti-hcv (abbott hcv eia 2.0, abbott diagnostic, chicago, il) positive > 6 months
boolean
C0281863 (UMLS CUI [1])
Serum hepatitis c viral rna quantitative Detectable | HCV RNA
Item
detectable serum quantitative hcv-rna (cobas taqman v2.0, roche diagnostics) with hcv rna > 800,000 iu/ml
boolean
C4272238 (UMLS CUI [1,1])
C3830527 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2])
Hepatitis C virus genotype determination
Item
hcv genotype 1 (inno-lipa, innogenetics)
boolean
C1533728 (UMLS CUI [1])
Biopsy of liver Consistent with Chronic Hepatitis C
Item
a liver biopsy consistent with the diagnosis of chronic hepatitis c
boolean
C0193388 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Anemia | Hemoglobin measurement | Gender
Item
anemia (hemoglobin < 13 gram per deciliter for men and < 12 gram per deciliter for women)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Neutropenia | Neutrophil count
Item
neutropenia (neutrophil count <1,500 per cubic milliliter)
boolean
C0027947 (UMLS CUI [1])
C0200633 (UMLS CUI [2])
Thrombocytopenia | Platelet Count measurement
Item
thrombocytopenia (platelet <90,000 per cubic milliliter)
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
HBV coinfection | HIV coinfection
Item
co-infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)
boolean
C2242656 (UMLS CUI [1])
C4062778 (UMLS CUI [2])
Alcoholic Intoxication, Chronic | Alcohol consumption Gram per day
Item
chronic alcohol abuse (daily consumption > 20 gram per day)
boolean
C0001973 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0439417 (UMLS CUI [2,2])
Decompensated liver disease Child-Pugh Classification
Item
decompensated liver disease (child-pugh class b or c)
boolean
C4075847 (UMLS CUI [1,1])
C4050412 (UMLS CUI [1,2])
Serum creatinine raised
Item
serum creatinine level more than 1.5 times the upper limit of normal
boolean
C0700225 (UMLS CUI [1])
Autoimmune liver disease
Item
autoimmune liver disease
boolean
C0400936 (UMLS CUI [1])
Neoplastic disease
Item
neoplastic disease
boolean
C1882062 (UMLS CUI [1])
Organ Transplantation
Item
an organ transplant
boolean
C0029216 (UMLS CUI [1])
Therapeutic immunosuppression
Item
immunosuppressive therapy
boolean
C0021079 (UMLS CUI [1])
Autoimmune Diseases Poorly controlled | Lung diseases Poorly controlled | Heart Diseases Poorly controlled | Mental disorders Poorly controlled | Nervous system disorder Poorly controlled | Poorly controlled diabetes mellitus
Item
poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
boolean
C0004364 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3,1])
C3853134 (UMLS CUI [3,2])
C0004936 (UMLS CUI [4,1])
C3853134 (UMLS CUI [4,2])
C0027765 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0554876 (UMLS CUI [6])
Drug abuse
Item
evidence of drug abuse
boolean
C0013146 (UMLS CUI [1])
Contraceptive methods Unwilling
Item
unwilling to have contraception
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

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