Informações:
Falhas:
ID
33806
Descrição
Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01341743
Link
https://clinicaltrials.gov/show/NCT01341743
Palavras-chave
Versões (1)
- 28/12/2018 28/12/2018 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
28 de dezembro de 2018
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Hepatitis B NCT01341743
Eligibility Hepatitis B NCT01341743
- StudyEvent: Eligibility
Similar models
Eligibility Hepatitis B NCT01341743
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
male or female aged 18-65 years;
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Protocol Compliance
Item
capable of understanding and signing the informed consent. willing to comply with the study requirements;
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
C0525058 (UMLS CUI [2])
Hepatitis B Surface Antigens Seropositive | Alanine aminotransferase measurement
Item
serum hbsag positive and alt<10uln at study screening;
boolean
C0019168 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0201836 (UMLS CUI [2])
C0521143 (UMLS CUI [1,2])
C0201836 (UMLS CUI [2])
Nucleoside Analogue Quantity | Nucleotide analog Quantity
Item
patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;
boolean
C1579410 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0597107 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1265611 (UMLS CUI [1,2])
C0597107 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Viral Breakthrough | Resistance Genotypic Prior Therapy
Item
history of viral breakthrough or genotypic resistance on previous therapy;
boolean
C4053869 (UMLS CUI [1])
C1514892 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C1514892 (UMLS CUI [2,1])
C0017431 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
Liver function Decompensated | Sign or Symptom Decompensation | Ascites | Bleeding varices | Encephalopathy | Peritonitis Spontaneous
Item
history of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
boolean
C0232741 (UMLS CUI [1,1])
C0205434 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0231187 (UMLS CUI [2,2])
C0003962 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C0085584 (UMLS CUI [5])
C0031154 (UMLS CUI [6,1])
C0205359 (UMLS CUI [6,2])
C0205434 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0231187 (UMLS CUI [2,2])
C0003962 (UMLS CUI [3])
C0333106 (UMLS CUI [4])
C0085584 (UMLS CUI [5])
C0031154 (UMLS CUI [6,1])
C0205359 (UMLS CUI [6,2])
Liver carcinoma | Signs and Symptoms Suggestive of Liver carcinoma
Item
patient has a history of hepatocellular carcinoma(hcc) or findings suggestive of possible hcc;
boolean
C2239176 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
C0037088 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C2239176 (UMLS CUI [2,3])
Exclusion Criteria Study Protocol
Item
other protocol defined exclusion criteria.
boolean
C0680251 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,2])