Protocol Compliance | Informed Consent
Item
participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Age
Item
age 18-65 years old.
boolean
C0001779 (UMLS CUI [1])
Hepatitis B surface antigen positive
Item
hbsag positive >6 months.
boolean
C0149709 (UMLS CUI [1])
Alanine aminotransferase increased
Item
alt >= 2 uln >6 months.
boolean
C0151905 (UMLS CUI [1])
Hepatitis D virus RNA Seropositive
Item
hdv rna positive serology.
boolean
C0486926 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
Serum antibody Hepatitis delta Antigens Immunoglobulin G | Serum antibody Hepatitis delta Antigens Immunoglobulin M
Item
serum antibody to hepatitis delta antigen of igg and igm class.
boolean
C3833453 (UMLS CUI [1,1])
C0057317 (UMLS CUI [1,2])
C0020852 (UMLS CUI [1,3])
C3833453 (UMLS CUI [2,1])
C0057317 (UMLS CUI [2,2])
C0020861 (UMLS CUI [2,3])
Knodell Fibrosis Score | Hepatitis delta Antigens Positive Biopsy of liver
Item
knodell score hai >= 6 and f >= 0; positive test for intrahepatic delta antigen in liver biopsy.
boolean
C3898641 (UMLS CUI [1])
C0057317 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0193388 (UMLS CUI [2,3])
Childbearing Potential Contraceptive methods | Postmenopausal state | Sex Behavior | Hormonal contraception | Intrauterine Devices prescribed | Female Condoms | Vaginal Spermicides | Female Sterilization | Hysterectomy | Tubal Ligation
Item
women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed iud, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232970 (UMLS CUI [2])
C0036864 (UMLS CUI [3])
C2985296 (UMLS CUI [4])
C0021900 (UMLS CUI [5,1])
C0278329 (UMLS CUI [5,2])
C0221829 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0015787 (UMLS CUI [8])
C0020699 (UMLS CUI [9])
C0520483 (UMLS CUI [10])
Disease Interferes with Clinical Trial Evaluation | Disease Free of | Hepatitis B, Chronic | Hepatitis D, Chronic
Item
participants must be free of any clinically significant disease (other than chronic hepatitis b and d), that would interfere with study evaluations.
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C1261322 (UMLS CUI [1,4])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C0524909 (UMLS CUI [3])
C0524911 (UMLS CUI [4])
Protocol Compliance | maintain symptom diary | Severity of Symptom Scale | Medication record | Adverse event Records
Item
participants must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
boolean
C0525058 (UMLS CUI [1])
C2216446 (UMLS CUI [2])
C3897633 (UMLS CUI [3])
C0677081 (UMLS CUI [4])
C0877248 (UMLS CUI [5,1])
C0034869 (UMLS CUI [5,2])
Age
Item
age <18 and >65.
boolean
C0001779 (UMLS CUI [1])
Hepatitis C | HIV Infection
Item
concomitant hcv and/or hiv infection.
boolean
C0019196 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
Liver Failure | Elevated total bilirubin | Prolonged prothrombin time (PT) | Serum albumin measurement | Ascites | Bleeding varices | Hepatic Encephalopathy
Item
actual liver failure (total serum bilirubin >2.5 x normal, prolonged prothrombin time >3 sec, serum albumin <3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy).
boolean
C0085605 (UMLS CUI [1])
C0741494 (UMLS CUI [2])
C2673577 (UMLS CUI [3])
C0523465 (UMLS CUI [4])
C0003962 (UMLS CUI [5])
C0333106 (UMLS CUI [6])
C0019151 (UMLS CUI [7])
Hepatitis, Toxic | Hepatitis, Autoimmune | Antinuclear antibodies (ANA) titer | Liver diseases Metabolic | Hepatolenticular Degeneration | Hemochromatosis | alpha 1-Antitrypsin Deficiency
Item
toxic or autoimmune hepatitis (ana titers > 1:160), metabolic liver diseases (wilson disease, hemochromatosis, α-1 antitrypsin deficiency)
boolean
C0019193 (UMLS CUI [1])
C0241910 (UMLS CUI [2])
C0373828 (UMLS CUI [3])
C0023895 (UMLS CUI [4,1])
C0311400 (UMLS CUI [4,2])
C0019202 (UMLS CUI [5])
C0018995 (UMLS CUI [6])
C0221757 (UMLS CUI [7])
Pregnancy | Breast Feeding
Item
women who are pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Leukopenia | Neutropenia | Hemoglobin measurement | Disease Severe | Cardiomyopathies | Diabetes Mellitus | Hypertensive disease | Neoplastic disease | nervous system disorder | Malnutrition
Item
leukopenia (<2500/mm^3), neutropenia (<1000/mm^3), hemoglobin <10 g/dl, presence of other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension, neoplasia, neurologic diseases, malnutrition).
boolean
C0023530 (UMLS CUI [1])
C0027947 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0878544 (UMLS CUI [5])
C0011849 (UMLS CUI [6])
C0020538 (UMLS CUI [7])
C1882062 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0162429 (UMLS CUI [10])
Antiviral Therapy | Immunomodulators | Steroid therapy | Chemotherapy
Item
antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6 months of the participation in the study.
boolean
C0280274 (UMLS CUI [1])
C1527392 (UMLS CUI [2])
C0149783 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
Depressive disorder | Mental disorders
Item
depression and/or psychiatric disorders.
boolean
C0011581 (UMLS CUI [1])
C0004936 (UMLS CUI [2])