ID

13700

Beskrivning

Hepatitis C Rimantadine and Antiviral Combination Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01413490

Länk

https://clinicaltrials.gov/show/NCT01413490

Nyckelord

  1. 2016-02-29 2016-02-29 -
Uppladdad den

29 februari 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :


Inga kommentarer

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Hepatitis C NCT01413490

Eligibility Hepatitis C NCT01413490

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have a diagnosis of hcv infection, genotype 1 or genotype 3
Beskrivning

infection Hepatitis C; Genotype

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3714514
UMLS CUI [1,2]
C0019196
be eligible for standard combination therapy with pegylated ifn and ribavirin
Beskrivning

combination therapy ribavirin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013218
UMLS CUI [1,2]
C0035525
be at least 18 but no more than 65 years of age
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
have signed an informed consent indicating that the patient is aware of the infectious nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests
Beskrivning

compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C1321605
have no contraindications to receiving rimantadine therapy
Beskrivning

contraindication rimantadine

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0035629
have blood results within defined acceptable haematological and biochemical parameters (haemoglobin >10 g/dl, platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l, creatinine <150 umol/l
Beskrivning

haemoglobin; platelet count

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0032181
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have dementia or altered mental status that would prohibit informed consent
Beskrivning

Informed Consent Limited Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
have previously received treatment for hcv infection (i.e. are currently treatment naïve)
Beskrivning

therapy hepatitis c

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0019196
have any condition which would deem the patient ineligible for combination therapy with pegylated ifn or ribavirin. this includes pregnancy, significant cardiac, renal or autoimmune disease, severe depression or psychosis, and previous organ transplantation
Beskrivning

comorbidity affecting treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0087111
cirrhosis or liver failure as evidenced by clinical (cutaneous stigmata of chronic liver disease, ascites, encephalopathy), ultrasonic (cirrhotic appearance of liver, ascites) or biochemical (platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l) evidence, routinely collated in all patients diagnosed with hcv
Beskrivning

cirrhosis; liver failure; encephalopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0085605
UMLS CUI [3]
C0085584
any condition which would preclude the use of rimantadine. this comprises significant renal impairment (creatinine >150), pregnancy, epilepsy or history of unexplained seizures
Beskrivning

rimantadine; epilepsy; Renal Insufficiency

Datatyp

boolean

Alias
UMLS CUI [1]
C0035629
UMLS CUI [2]
C0014544
UMLS CUI [3]
C1565489
have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the chief investigators, would make the patient inappropriate for this study. this includes the presence of end stage liver disease (cirrhosis), and hiv infection
Beskrivning

Compliance behavior Limited Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488

Similar models

Eligibility Hepatitis C NCT01413490

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
infection Hepatitis C; Genotype
Item
have a diagnosis of hcv infection, genotype 1 or genotype 3
boolean
C3714514 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
combination therapy ribavirin
Item
be eligible for standard combination therapy with pegylated ifn and ribavirin
boolean
C0013218 (UMLS CUI [1,1])
C0035525 (UMLS CUI [1,2])
age
Item
be at least 18 but no more than 65 years of age
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
have signed an informed consent indicating that the patient is aware of the infectious nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts
boolean
C0021430 (UMLS CUI [1])
compliance
Item
be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests
boolean
C1321605 (UMLS CUI [1])
contraindication rimantadine
Item
have no contraindications to receiving rimantadine therapy
boolean
C1301624 (UMLS CUI [1,1])
C0035629 (UMLS CUI [1,2])
haemoglobin; platelet count
Item
have blood results within defined acceptable haematological and biochemical parameters (haemoglobin >10 g/dl, platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l, creatinine <150 umol/l
boolean
C0518015 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Limited Comorbidity
Item
have dementia or altered mental status that would prohibit informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
therapy hepatitis c
Item
have previously received treatment for hcv infection (i.e. are currently treatment naïve)
boolean
C0087111 (UMLS CUI [1,1])
C0019196 (UMLS CUI [1,2])
comorbidity affecting treatment
Item
have any condition which would deem the patient ineligible for combination therapy with pegylated ifn or ribavirin. this includes pregnancy, significant cardiac, renal or autoimmune disease, severe depression or psychosis, and previous organ transplantation
boolean
C0009488 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
cirrhosis; liver failure; encephalopathy
Item
cirrhosis or liver failure as evidenced by clinical (cutaneous stigmata of chronic liver disease, ascites, encephalopathy), ultrasonic (cirrhotic appearance of liver, ascites) or biochemical (platelet count >150 x 109/l, bilirubin <25 umol/l, albumin >35 g/l) evidence, routinely collated in all patients diagnosed with hcv
boolean
C0023890 (UMLS CUI [1])
C0085605 (UMLS CUI [2])
C0085584 (UMLS CUI [3])
rimantadine; epilepsy; Renal Insufficiency
Item
any condition which would preclude the use of rimantadine. this comprises significant renal impairment (creatinine >150), pregnancy, epilepsy or history of unexplained seizures
boolean
C0035629 (UMLS CUI [1])
C0014544 (UMLS CUI [2])
C1565489 (UMLS CUI [3])
Compliance behavior Limited Comorbidity
Item
have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the chief investigators, would make the patient inappropriate for this study. this includes the presence of end stage liver disease (cirrhosis), and hiv infection
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial