ID

31247

Beschrijving

Increasing Cure Rate of Hepatitis C Therapy in Obese Hepatitis C Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00871845

Link

https://clinicaltrials.gov/show/NCT00871845

Trefwoorden

Versies (1)
  1. 02-08-18 02-08-18 -
Houder van rechten

See clinicaltrials.gov

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2 augustus 2018

DOI

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Creative Commons BY 4.0
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Eligibility Obesity NCT00871845

Engels

Eligibility Obesity NCT00871845

1 Formulieren  
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00871845
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years or older
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
positive diagnosis of hepatitis c, by polymerase chain reaction (pcr
Beschrijving

Hepatitis C Polymerase Chain Reaction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019196
UMLS CUI [1,2]
C0032520
scheduled to start treatment of hepatitis c by peg interferon and ribavirin
Beschrijving

Scheduled treatment Hepatitis C | PEG-interferon alfa | Ribavirin

Datatype

boolean

Alias
UMLS CUI [1,1]
C3844437
UMLS CUI [1,2]
C0019196
UMLS CUI [2]
C0907160
UMLS CUI [3]
C0035525
agreeing to give a written consent to participate in this study.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients under 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
refusal to give a consent to participate in the study
Beschrijving

Informed Consent Refused

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1705116
history of recreational drug or alcohol use in the preceding 6 months
Beschrijving

Alcohol or Other Drugs use

Datatype

boolean

Alias
UMLS CUI [1]
C0237123
pregnancy by hcg pregnancy testing which will be done prior to and monthly during the 12 month hepatitis c therapy and for 6 months following the end of treatment
Beschrijving

Pregnancy HCG pregnancy test

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0546577
plan for pregnancy during the study period
Beschrijving

Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032992
failure to adhere to contraceptive methods
Beschrijving

Contraceptive methods Adherence failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C1510802
UMLS CUI [1,3]
C0231175
hiv disease
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
evidence of cirrhosis or confirmed hepatocellular carcinoma (hcc), evidence of decompensated liver disease or presence of other liver diseases such as hepatitis b, hemochromatosis, autoimmune hepatitis and wilson disease
Beschrijving

Liver Cirrhosis | Liver carcinoma | Decompensated Liver Disease | Liver diseases | Hepatitis B | Hemochromatosis | Hepatitis, Autoimmune | Hepatolenticular Degeneration

Datatype

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C2239176
UMLS CUI [3]
C0745744
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0018995
UMLS CUI [7]
C0241910
UMLS CUI [8]
C0019202
patients will be removed from the study if they develop severe side effects to ifn (e.g marked depression, autoimmune reactions like thyroiditis, aplastic anemia..), severe side effects to ribavirin (e.g. marked hemolysis) or intolerance of orlistat/placebo (e.g. allergic reaction, diarrhea, flatulence..) and withdrawal of the consent.
Beschrijving

Adverse effects Severe Interferon | Depressive disorder Marked | Autoimmune reaction | Thyroiditis | Aplastic Anemia | Adverse effects Severe Ribavirin | Hemolysis Marked | Intolerance to Orlistat | Intolerance to placebo | Allergic Reaction | Diarrhea | Flatulence | Informed Consent Withdrawal

Datatype

boolean

Alias
UMLS CUI [1,1]
C0879626
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0021747
UMLS CUI [2,1]
C0011581
UMLS CUI [2,2]
C1706089
UMLS CUI [3]
C0443146
UMLS CUI [4]
C0040147
UMLS CUI [5]
C0002874
UMLS CUI [6,1]
C0879626
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0035525
UMLS CUI [7,1]
C0019054
UMLS CUI [7,2]
C1706089
UMLS CUI [8,1]
C1744706
UMLS CUI [8,2]
C0076275
UMLS CUI [9,1]
C1744706
UMLS CUI [9,2]
C1696465
UMLS CUI [10]
C1527304
UMLS CUI [11]
C0011991
UMLS CUI [12]
C0016204
UMLS CUI [13,1]
C0021430
UMLS CUI [13,2]
C2349954
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Similar models

Eligibility Obesity NCT00871845

1 Formulieren
  1. StudyEvent: Eligibility
    1. Eligibility Obesity NCT00871845
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years or older
boolean
C0001779 (UMLS CUI [1])
Hepatitis C Polymerase Chain Reaction
Item
positive diagnosis of hepatitis c, by polymerase chain reaction (pcr
boolean
C0019196 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
Scheduled treatment Hepatitis C | PEG-interferon alfa | Ribavirin
Item
scheduled to start treatment of hepatitis c by peg interferon and ribavirin
boolean
C3844437 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
C0907160 (UMLS CUI [2])
C0035525 (UMLS CUI [3])
Informed Consent
Item
agreeing to give a written consent to participate in this study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients under 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent Refused
Item
refusal to give a consent to participate in the study
boolean
C0021430 (UMLS CUI [1,1])
C1705116 (UMLS CUI [1,2])
Alcohol or Other Drugs use
Item
history of recreational drug or alcohol use in the preceding 6 months
boolean
C0237123 (UMLS CUI [1])
Pregnancy HCG pregnancy test
Item
pregnancy by hcg pregnancy testing which will be done prior to and monthly during the 12 month hepatitis c therapy and for 6 months following the end of treatment
boolean
C0032961 (UMLS CUI [1,1])
C0546577 (UMLS CUI [1,2])
Pregnancy, Planned
Item
plan for pregnancy during the study period
boolean
C0032992 (UMLS CUI [1])
Contraceptive methods Adherence failed
Item
failure to adhere to contraceptive methods
boolean
C0700589 (UMLS CUI [1,1])
C1510802 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
HIV Infection
Item
hiv disease
boolean
C0019693 (UMLS CUI [1])
Liver Cirrhosis | Liver carcinoma | Decompensated Liver Disease | Liver diseases | Hepatitis B | Hemochromatosis | Hepatitis, Autoimmune | Hepatolenticular Degeneration
Item
evidence of cirrhosis or confirmed hepatocellular carcinoma (hcc), evidence of decompensated liver disease or presence of other liver diseases such as hepatitis b, hemochromatosis, autoimmune hepatitis and wilson disease
boolean
C0023890 (UMLS CUI [1])
C2239176 (UMLS CUI [2])
C0745744 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0018995 (UMLS CUI [6])
C0241910 (UMLS CUI [7])
C0019202 (UMLS CUI [8])
Adverse effects Severe Interferon | Depressive disorder Marked | Autoimmune reaction | Thyroiditis | Aplastic Anemia | Adverse effects Severe Ribavirin | Hemolysis Marked | Intolerance to Orlistat | Intolerance to placebo | Allergic Reaction | Diarrhea | Flatulence | Informed Consent Withdrawal
Item
patients will be removed from the study if they develop severe side effects to ifn (e.g marked depression, autoimmune reactions like thyroiditis, aplastic anemia..), severe side effects to ribavirin (e.g. marked hemolysis) or intolerance of orlistat/placebo (e.g. allergic reaction, diarrhea, flatulence..) and withdrawal of the consent.
boolean
C0879626 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0021747 (UMLS CUI [1,3])
C0011581 (UMLS CUI [2,1])
C1706089 (UMLS CUI [2,2])
C0443146 (UMLS CUI [3])
C0040147 (UMLS CUI [4])
C0002874 (UMLS CUI [5])
C0879626 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0035525 (UMLS CUI [6,3])
C0019054 (UMLS CUI [7,1])
C1706089 (UMLS CUI [7,2])
C1744706 (UMLS CUI [8,1])
C0076275 (UMLS CUI [8,2])
C1744706 (UMLS CUI [9,1])
C1696465 (UMLS CUI [9,2])
C1527304 (UMLS CUI [10])
C0011991 (UMLS CUI [11])
C0016204 (UMLS CUI [12])
C0021430 (UMLS CUI [13,1])
C2349954 (UMLS CUI [13,2])
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