ID

20940

Descripción

Rosuvastatin for Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT00371579

Link

https://clinicaltrials.gov/show/NCT00371579

Palabras clave

Versiones (2)
  1. 29/3/17 29/3/17 -
  2. 17/9/21 17/9/21 -
Subido en

29 de marzo de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00371579

Inglés

Eligibility Hepatitis C NCT00371579

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age between 18 and 65 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
all patients with hepatitis c (all genotypes)
Descripción

Hepatitis C | Hepatitis C virus genotype All

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C1148363
UMLS CUI [2,2]
C0444868
negative for hepatitis b and hiv
Descripción

Hepatitis B test negative | HIV negative

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1611173
UMLS CUI [2]
C0481430
alat < 2,5 x below the upper limit of normal
Descripción

Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201836
serological evidence of hepatitis c infection with detectable hcv-rna (with bayer versant hcv bdna v3.0)
Descripción

Hepatitis C Evidence Serological | HCV viral load Detectable

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C3887511
UMLS CUI [1,3]
C0205473
UMLS CUI [2,1]
C1868902
UMLS CUI [2,2]
C3830527
failed current standard of care treatment with peginterferon and ribavirin
Descripción

PEGINTERFERON Standard therapy failed | Ribavirin Standard therapy failed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0982327
UMLS CUI [1,2]
C2936643
UMLS CUI [1,3]
C0231175
UMLS CUI [2,1]
C0035525
UMLS CUI [2,2]
C2936643
UMLS CUI [2,3]
C0231175
who-score ≤1
Descripción

WHO performance status scale

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1298650
fertile women must have a negative pregnancy test in the week before start of medication. use of contraceptives during the whole study-period
Descripción

Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
physically and mentally able to attend outpatients clinics
Descripción

Ambulatory Care Facilities Attend Ability

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0002424
UMLS CUI [1,2]
C1999232
UMLS CUI [1,3]
C0085732
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
hepatitis c patiënts naive for (peg)interferon and ribavirin treatment
Descripción

Hepatitis C | Interferon Therapy naive | PEGINTERFERON Therapy naive | Ribavirin Therapy naive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019196
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0919936
UMLS CUI [3,1]
C0982327
UMLS CUI [3,2]
C0919936
UMLS CUI [4,1]
C0035525
UMLS CUI [4,2]
C0919936
alcohol abuses (> 20 grams per day) in the last year
Descripción

Alcohol abuse Grams per day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0439417
liver cirrhosis detected through liver biopsy or decompensated liver disease (child-pugh b or c)
Descripción

Liver Cirrhosis Biopsy of liver | Decompensated liver disease Child-Pugh Classification

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0023890
UMLS CUI [1,2]
C0193388
UMLS CUI [2,1]
C4075847
UMLS CUI [2,2]
C2347612
concomitant treatment with hepatotoxic medication / interfering with cyp450 system: anti-fungal medication (voriconazole), antibiotics (gentamycine, azitromycine, claritromycin, erytromycin), immuun-suppresive drugs (cyclosporine), anti-arythmia (diltiazem, verapamil) and tuberculostatic drugs (rifampicin).
Descripción

Pharmaceutical Preparation Hepatotoxicity Interferes with Cytochrome P450 | Antifungal Agents | voriconazole | Antibiotics | Gentamicin | Azithromycin | Clarithromycin | Erythromycin | Immunosuppressive Agents | Cyclosporine | Anti-Arrhythmia Agents | Diltiazem | Verapamil | Antitubercular Agents | Rifampin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0235378
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0010762
UMLS CUI [2]
C0003308
UMLS CUI [3]
C0393080
UMLS CUI [4]
C0003232
UMLS CUI [5]
C3854019
UMLS CUI [6]
C0052796
UMLS CUI [7]
C0055856
UMLS CUI [8]
C0014806
UMLS CUI [9]
C0021081
UMLS CUI [10]
C0010592
UMLS CUI [11]
C0003195
UMLS CUI [12]
C0012373
UMLS CUI [13]
C0042523
UMLS CUI [14]
C0003448
UMLS CUI [15]
C0035608
current statin use
Descripción

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0360714
active pregnancy or wish of pregnangy
Descripción

Pregnancy | Pregnancy, Planned

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
use of grapefruit juice
Descripción

GRAPEFRUIT JUICE

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0452456
mentally not fit to participate in the study
Descripción

Study Subject Participation Status Psychologically unfit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3841804
daily use of more than 2 grams of paracetamol
Descripción

Acetaminophen Grams per day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0000970
UMLS CUI [1,2]
C0439417
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Similar models

Eligibility Hepatitis C NCT00371579

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age between 18 and 65 years
boolean
C0001779 (UMLS CUI [1])
Hepatitis C | Hepatitis C virus genotype All
Item
all patients with hepatitis c (all genotypes)
boolean
C0019196 (UMLS CUI [1])
C1148363 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Hepatitis B test negative | HIV negative
Item
negative for hepatitis b and hiv
boolean
C1611173 (UMLS CUI [1])
C0481430 (UMLS CUI [2])
Alanine aminotransferase measurement
Item
alat < 2,5 x below the upper limit of normal
boolean
C0201836 (UMLS CUI [1])
Hepatitis C Evidence Serological | HCV viral load Detectable
Item
serological evidence of hepatitis c infection with detectable hcv-rna (with bayer versant hcv bdna v3.0)
boolean
C0019196 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C1868902 (UMLS CUI [2,1])
C3830527 (UMLS CUI [2,2])
PEGINTERFERON Standard therapy failed | Ribavirin Standard therapy failed
Item
failed current standard of care treatment with peginterferon and ribavirin
boolean
C0982327 (UMLS CUI [1,1])
C2936643 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0035525 (UMLS CUI [2,1])
C2936643 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
WHO performance status scale
Item
who-score ≤1
boolean
C1298650 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
fertile women must have a negative pregnancy test in the week before start of medication. use of contraceptives during the whole study-period
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Ambulatory Care Facilities Attend Ability
Item
physically and mentally able to attend outpatients clinics
boolean
C0002424 (UMLS CUI [1,1])
C1999232 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hepatitis C | Interferon Therapy naive | PEGINTERFERON Therapy naive | Ribavirin Therapy naive
Item
hepatitis c patiënts naive for (peg)interferon and ribavirin treatment
boolean
C0019196 (UMLS CUI [1])
C3652465 (UMLS CUI [2,1])
C0919936 (UMLS CUI [2,2])
C0982327 (UMLS CUI [3,1])
C0919936 (UMLS CUI [3,2])
C0035525 (UMLS CUI [4,1])
C0919936 (UMLS CUI [4,2])
Alcohol abuse Grams per day
Item
alcohol abuses (> 20 grams per day) in the last year
boolean
C0085762 (UMLS CUI [1,1])
C0439417 (UMLS CUI [1,2])
Liver Cirrhosis Biopsy of liver | Decompensated liver disease Child-Pugh Classification
Item
liver cirrhosis detected through liver biopsy or decompensated liver disease (child-pugh b or c)
boolean
C0023890 (UMLS CUI [1,1])
C0193388 (UMLS CUI [1,2])
C4075847 (UMLS CUI [2,1])
C2347612 (UMLS CUI [2,2])
Pharmaceutical Preparation Hepatotoxicity Interferes with Cytochrome P450 | Antifungal Agents | voriconazole | Antibiotics | Gentamicin | Azithromycin | Clarithromycin | Erythromycin | Immunosuppressive Agents | Cyclosporine | Anti-Arrhythmia Agents | Diltiazem | Verapamil | Antitubercular Agents | Rifampin
Item
concomitant treatment with hepatotoxic medication / interfering with cyp450 system: anti-fungal medication (voriconazole), antibiotics (gentamycine, azitromycine, claritromycin, erytromycin), immuun-suppresive drugs (cyclosporine), anti-arythmia (diltiazem, verapamil) and tuberculostatic drugs (rifampicin).
boolean
C0013227 (UMLS CUI [1,1])
C0235378 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0010762 (UMLS CUI [1,4])
C0003308 (UMLS CUI [2])
C0393080 (UMLS CUI [3])
C0003232 (UMLS CUI [4])
C3854019 (UMLS CUI [5])
C0052796 (UMLS CUI [6])
C0055856 (UMLS CUI [7])
C0014806 (UMLS CUI [8])
C0021081 (UMLS CUI [9])
C0010592 (UMLS CUI [10])
C0003195 (UMLS CUI [11])
C0012373 (UMLS CUI [12])
C0042523 (UMLS CUI [13])
C0003448 (UMLS CUI [14])
C0035608 (UMLS CUI [15])
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Item
current statin use
boolean
C0360714 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
active pregnancy or wish of pregnangy
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
GRAPEFRUIT JUICE
Item
use of grapefruit juice
boolean
C0452456 (UMLS CUI [1])
Study Subject Participation Status Psychologically unfit
Item
mentally not fit to participate in the study
boolean
C2348568 (UMLS CUI [1,1])
C3841804 (UMLS CUI [1,2])
Acetaminophen Grams per day
Item
daily use of more than 2 grams of paracetamol
boolean
C0000970 (UMLS CUI [1,1])
C0439417 (UMLS CUI [1,2])
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