ID

27851

Description

Effects of Telbivudine and Tenofovir Disproxil Fumarate on the Kinetics of Hepatitis B Virus DNA in Chronic Hepatitis B (CHB); ODM derived from: https://clinicaltrials.gov/show/NCT00804622

Link

https://clinicaltrials.gov/show/NCT00804622

Keywords

Versions (1)
  1. 12/1/17 12/1/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Chronic Hepatitis B NCT00804622

English

Eligibility Chronic Hepatitis B NCT00804622

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must meet all of the following inclusion criteria at screening to be eligible for participation in this study.
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. chronic hbv infection, defined as positive serum hbsag for at least 6 months, or hbsag positive > 3 months and negative for igm anti-hbc and positive for igg anti-hbc
Description

Hepatitis B, Chronic | Hepatitis B surface antigen positive | Anti-HBc IgM antibody negative | Anti-HBc IgG antibody positive

Data type

boolean

Alias
UMLS CUI [1]
C0524909
UMLS CUI [2]
C0149709
UMLS CUI [3]
C4049511
UMLS CUI [4]
C1096145
2. age < 40 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. hbeag positive
Description

Hepatitis B e antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0392390
4. hbv dna ≥ 10^7 copies/ml by abbott real-time pcr
Description

Hepatitis B DNA Measurement Real-Time Polymerase Chain Reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C3641250
UMLS CUI [1,2]
C1709846
5. alt ≤ 1 uln
Description

Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
6. willing and able to provide written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. negative serum β-hcg (for females of childbearing potential only)
Description

Childbearing Potential Serum hCG Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C2208823
UMLS CUI [1,3]
C1513916
8. calculated creatinine clearance ≥ 70 ml/min by the following formula: (140 - age in years) x (body weight [kg]) / (72) x (serum creatinine [mg/dl]) [note: multiply estimated rate by 0.85 for women]
Description

Estimation of creatinine clearance by Cockcroft-Gault formula | Gender

Data type

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0079399
9. hemoglobin ≥ 10 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
10. neutrophils ≥ 1,500 /mm^3
Description

Neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0200633
11. no prior oral hbv therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for hbv infection)
Description

Absence Therapeutic procedure Oral HBV | Absence Nucleotides | Absence Nucleosides | Absence Investigational New Drugs Hepatitis B

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1527415
UMLS CUI [1,4]
C0019163
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0028630
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0028621
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0013230
UMLS CUI [4,3]
C0019163
12. is willing and able to comply with the study drug regimen and all other study procedures and requirements
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
13. is willing and able to provide written informed consent before any study assessment is perform.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients will be excluded from the study for any of the criteria:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 × uln, pt > 1.2 × uln, platelets < 150,000/mm3, serum albumin < 3.5 g/dl, or prior history of clinical hepatic decompensation (e.g. ascites, jaundice, encephalopathy, variceal hemorrhage).
Description

Liver disease Decompensated | Serum direct (conjugated) bilirubin test | Prothrombin time increased | Platelet Count measurement | Serum albumin measurement | Hepatic decompensation | Ascites | Jaundice | Encephalopathy | Bleeding varices

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205434
UMLS CUI [2]
C1278038
UMLS CUI [3]
C0151872
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0523465
UMLS CUI [6]
C1394798
UMLS CUI [7]
C0003962
UMLS CUI [8]
C2010848
UMLS CUI [9]
C0085584
UMLS CUI [10]
C0333106
2. received interferon (pegylated or not) therapy within 6 months of the screening visit
Description

Interferon | Pegylated interferon alfa

Data type

boolean

Alias
UMLS CUI [1]
C3652465
UMLS CUI [2]
C0907160
3. α-fetoprotein > 50 ng/ml
Description

Alpha-fetoprotein measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201539
4. evidence of hepatocellular carcinoma (hcc)
Description

Liver carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C2239176
5. co-infection with hcv (by serology), hiv, or hdv.
Description

HCV coinfection Serology | HIV coinfection Serology | HDV Coinfection Serology

Data type

boolean

Alias
UMLS CUI [1,1]
C1698259
UMLS CUI [1,2]
C0036743
UMLS CUI [2,1]
C4062778
UMLS CUI [2,2]
C0036743
UMLS CUI [3,1]
C0011220
UMLS CUI [3,2]
C0275524
UMLS CUI [3,3]
C0036743
6. significant renal, cardiovascular, pulmonary, or neurological disease.
Description

Kidney Diseases | Cardiovascular Diseases | Lung diseases | Nervous system disorder

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0007222
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0027765
7. received solid organ or bone marrow transplantation.
Description

Solid organ transplant | Bone Marrow Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0730400
UMLS CUI [2]
C0005961
8. is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
Description

Immunomodulators | Adrenal Cortex Hormones | Investigational New Drugs | Pharmaceutical Preparations Nephrotoxic | Pharmaceutical Preparations Changing Renal Excretion

Data type

boolean

Alias
UMLS CUI [1]
C1527392
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0013230
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C1514118
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0392747
UMLS CUI [5,3]
C1373187
9. has proximal tubulopathy.
Description

Proximal tubulopathy

Data type

boolean

Alias
UMLS CUI [1]
C1839603
10. use of other investigational drugs at the time of enrollment, or within 30 days
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
11. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Class Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0456387
UMLS CUI [2,4]
C2348205
12. is pregnant or breastfeeding. women of childbearing potential must have a negative serum β - hcg during screening.
Description

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test (B-HCG) Negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430060
UMLS CUI [3,3]
C1513916
13. is a women of child-bearing potential (wocbp), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum fsh levels >40 miu/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: iud, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
Description

Childbearing Potential | Gender Exclusion Coitus Partner | Gender Partner Vasectomy | Gender Partner Male sterilization | Exception Postmenopausal state | Amenorrhea Spontaneous Duration | Serum follicle stimulating hormone measurement | Bilateral oophorectomy | Hysterectomy | Contraceptive methods | Female Sterilization | Bilateral tubal ligation | Vasectomy | Hormonal contraception | Contraceptive implant | Contraceptive Patch | Contraceptives, Oral | Barrier Contraception Double | IUD | Condoms, Male | Female Condoms | Vaginal Spermicides | Vaginal contraceptive diaphragm | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C2828389
UMLS CUI [2,3]
C0009253
UMLS CUI [2,4]
C0682323
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C0042387
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0682323
UMLS CUI [4,3]
C0024559
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0232970
UMLS CUI [6,1]
C0002453
UMLS CUI [6,2]
C0205359
UMLS CUI [6,3]
C0449238
UMLS CUI [7]
C0455276
UMLS CUI [8]
C0278321
UMLS CUI [9]
C0020699
UMLS CUI [10]
C0700589
UMLS CUI [11]
C0015787
UMLS CUI [12]
C0589114
UMLS CUI [13]
C0042387
UMLS CUI [14]
C2985296
UMLS CUI [15]
C1657106
UMLS CUI [16]
C2985284
UMLS CUI [17]
C0009905
UMLS CUI [18,1]
C0004764
UMLS CUI [18,2]
C0205173
UMLS CUI [19]
C0021900
UMLS CUI [20]
C0009653
UMLS CUI [21]
C0221829
UMLS CUI [22]
C0087145
UMLS CUI [23]
C0042241
UMLS CUI [24]
C0183461
UMLS CUI [25]
C0493327
14. patient has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
Description

Comorbidity Excludes Protocol Compliance | Social situation Excludes Protocol Compliance | Comorbidity Interferes with Research results | Social situation Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0748872
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0009488
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
15. patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years. please refer to appendix 3.
Description

Substance Use Disorders | Illicit Drugs abuse

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0086190
UMLS CUI [2,2]
C0013146
16. patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir. please refer to appendix 1.
Description

Medical condition Acyclovir Patient need for | Medical condition Famciclovir Patient need for | Acyclovir Systemic Prolonged | Acyclovir Systemic Frequent | Famciclovir Systemic Prolonged | Famciclovir Systemic Frequent

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0001367
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0209227
UMLS CUI [2,3]
C0686904
UMLS CUI [3,1]
C0001367
UMLS CUI [3,2]
C0205373
UMLS CUI [3,3]
C0439590
UMLS CUI [4,1]
C0001367
UMLS CUI [4,2]
C0205373
UMLS CUI [4,3]
C0332183
UMLS CUI [5,1]
C0209227
UMLS CUI [5,2]
C0205373
UMLS CUI [5,3]
C0439590
UMLS CUI [6,1]
C0209227
UMLS CUI [6,2]
C0205373
UMLS CUI [6,3]
C0332183
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Similar models

Eligibility Chronic Hepatitis B NCT00804622

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
patients must meet all of the following inclusion criteria at screening to be eligible for participation in this study.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Hepatitis B, Chronic | Hepatitis B surface antigen positive | Anti-HBc IgM antibody negative | Anti-HBc IgG antibody positive
Item
1. chronic hbv infection, defined as positive serum hbsag for at least 6 months, or hbsag positive > 3 months and negative for igm anti-hbc and positive for igg anti-hbc
boolean
C0524909 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C4049511 (UMLS CUI [3])
C1096145 (UMLS CUI [4])
Age
Item
2. age < 40 years old
boolean
C0001779 (UMLS CUI [1])
Hepatitis B e antigen positive
Item
3. hbeag positive
boolean
C0392390 (UMLS CUI [1])
Hepatitis B DNA Measurement Real-Time Polymerase Chain Reaction
Item
4. hbv dna ≥ 10^7 copies/ml by abbott real-time pcr
boolean
C3641250 (UMLS CUI [1,1])
C1709846 (UMLS CUI [1,2])
Alanine aminotransferase measurement
Item
5. alt ≤ 1 uln
boolean
C0201836 (UMLS CUI [1])
Informed Consent
Item
6. willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Serum hCG Negative
Item
7. negative serum β-hcg (for females of childbearing potential only)
boolean
C3831118 (UMLS CUI [1,1])
C2208823 (UMLS CUI [1,2])
C1513916 (UMLS CUI [1,3])
Estimation of creatinine clearance by Cockcroft-Gault formula | Gender
Item
8. calculated creatinine clearance ≥ 70 ml/min by the following formula: (140 - age in years) x (body weight [kg]) / (72) x (serum creatinine [mg/dl]) [note: multiply estimated rate by 0.85 for women]
boolean
C2711451 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Hemoglobin measurement
Item
9. hemoglobin ≥ 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Neutrophil count
Item
10. neutrophils ≥ 1,500 /mm^3
boolean
C0200633 (UMLS CUI [1])
Absence Therapeutic procedure Oral HBV | Absence Nucleotides | Absence Nucleosides | Absence Investigational New Drugs Hepatitis B
Item
11. no prior oral hbv therapy (e.g., nucleotide and/or nucleoside therapy or other investigational agents for hbv infection)
boolean
C0332197 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C0019163 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0028630 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0028621 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
C0019163 (UMLS CUI [4,3])
Protocol Compliance
Item
12. is willing and able to comply with the study drug regimen and all other study procedures and requirements
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
13. is willing and able to provide written informed consent before any study assessment is perform.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients will be excluded from the study for any of the criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Liver disease Decompensated | Serum direct (conjugated) bilirubin test | Prothrombin time increased | Platelet Count measurement | Serum albumin measurement | Hepatic decompensation | Ascites | Jaundice | Encephalopathy | Bleeding varices
Item
1. decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 × uln, pt > 1.2 × uln, platelets < 150,000/mm3, serum albumin < 3.5 g/dl, or prior history of clinical hepatic decompensation (e.g. ascites, jaundice, encephalopathy, variceal hemorrhage).
boolean
C0023895 (UMLS CUI [1,1])
C0205434 (UMLS CUI [1,2])
C1278038 (UMLS CUI [2])
C0151872 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0523465 (UMLS CUI [5])
C1394798 (UMLS CUI [6])
C0003962 (UMLS CUI [7])
C2010848 (UMLS CUI [8])
C0085584 (UMLS CUI [9])
C0333106 (UMLS CUI [10])
Interferon | Pegylated interferon alfa
Item
2. received interferon (pegylated or not) therapy within 6 months of the screening visit
boolean
C3652465 (UMLS CUI [1])
C0907160 (UMLS CUI [2])
Alpha-fetoprotein measurement
Item
3. α-fetoprotein > 50 ng/ml
boolean
C0201539 (UMLS CUI [1])
Liver carcinoma
Item
4. evidence of hepatocellular carcinoma (hcc)
boolean
C2239176 (UMLS CUI [1])
HCV coinfection Serology | HIV coinfection Serology | HDV Coinfection Serology
Item
5. co-infection with hcv (by serology), hiv, or hdv.
boolean
C1698259 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C4062778 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C0011220 (UMLS CUI [3,1])
C0275524 (UMLS CUI [3,2])
C0036743 (UMLS CUI [3,3])
Kidney Diseases | Cardiovascular Diseases | Lung diseases | Nervous system disorder
Item
6. significant renal, cardiovascular, pulmonary, or neurological disease.
boolean
C0022658 (UMLS CUI [1])
C0007222 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
Solid organ transplant | Bone Marrow Transplantation
Item
7. received solid organ or bone marrow transplantation.
boolean
C0730400 (UMLS CUI [1])
C0005961 (UMLS CUI [2])
Immunomodulators | Adrenal Cortex Hormones | Investigational New Drugs | Pharmaceutical Preparations Nephrotoxic | Pharmaceutical Preparations Changing Renal Excretion
Item
8. is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
boolean
C1527392 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C0013227 (UMLS CUI [4,1])
C1514118 (UMLS CUI [4,2])
C0013227 (UMLS CUI [5,1])
C0392747 (UMLS CUI [5,2])
C1373187 (UMLS CUI [5,3])
Proximal tubulopathy
Item
9. has proximal tubulopathy.
boolean
C1839603 (UMLS CUI [1])
Investigational New Drugs
Item
10. use of other investigational drugs at the time of enrollment, or within 30 days
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Class Similar
Item
11. history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test (B-HCG) Negative
Item
12. is pregnant or breastfeeding. women of childbearing potential must have a negative serum β - hcg during screening.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430060 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
Childbearing Potential | Gender Exclusion Coitus Partner | Gender Partner Vasectomy | Gender Partner Male sterilization | Exception Postmenopausal state | Amenorrhea Spontaneous Duration | Serum follicle stimulating hormone measurement | Bilateral oophorectomy | Hysterectomy | Contraceptive methods | Female Sterilization | Bilateral tubal ligation | Vasectomy | Hormonal contraception | Contraceptive implant | Contraceptive Patch | Contraceptives, Oral | Barrier Contraception Double | IUD | Condoms, Male | Female Condoms | Vaginal Spermicides | Vaginal contraceptive diaphragm | Contraceptive Sponge | CERVICAL CAP FOR CONTRACEPTIVE USE
Item
13. is a women of child-bearing potential (wocbp), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum fsh levels >40 miu/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: iud, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap).
boolean
C3831118 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
C0009253 (UMLS CUI [2,3])
C0682323 (UMLS CUI [2,4])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C0042387 (UMLS CUI [3,3])
C0079399 (UMLS CUI [4,1])
C0682323 (UMLS CUI [4,2])
C0024559 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0232970 (UMLS CUI [5,2])
C0002453 (UMLS CUI [6,1])
C0205359 (UMLS CUI [6,2])
C0449238 (UMLS CUI [6,3])
C0455276 (UMLS CUI [7])
C0278321 (UMLS CUI [8])
C0020699 (UMLS CUI [9])
C0700589 (UMLS CUI [10])
C0015787 (UMLS CUI [11])
C0589114 (UMLS CUI [12])
C0042387 (UMLS CUI [13])
C2985296 (UMLS CUI [14])
C1657106 (UMLS CUI [15])
C2985284 (UMLS CUI [16])
C0009905 (UMLS CUI [17])
C0004764 (UMLS CUI [18,1])
C0205173 (UMLS CUI [18,2])
C0021900 (UMLS CUI [19])
C0009653 (UMLS CUI [20])
C0221829 (UMLS CUI [21])
C0087145 (UMLS CUI [22])
C0042241 (UMLS CUI [23])
C0183461 (UMLS CUI [24])
C0493327 (UMLS CUI [25])
Comorbidity Excludes Protocol Compliance | Social situation Excludes Protocol Compliance | Comorbidity Interferes with Research results | Social situation Interferes with Research results
Item
14. patient has any other concurrent medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0748872 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
Substance Use Disorders | Illicit Drugs abuse
Item
15. patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or illicit substance abuse within the preceding two years. please refer to appendix 3.
boolean
C0038586 (UMLS CUI [1])
C0086190 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
Medical condition Acyclovir Patient need for | Medical condition Famciclovir Patient need for | Acyclovir Systemic Prolonged | Acyclovir Systemic Frequent | Famciclovir Systemic Prolonged | Famciclovir Systemic Frequent
Item
16. patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir. please refer to appendix 1.
boolean
C3843040 (UMLS CUI [1,1])
C0001367 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0209227 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C0001367 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
C0439590 (UMLS CUI [3,3])
C0001367 (UMLS CUI [4,1])
C0205373 (UMLS CUI [4,2])
C0332183 (UMLS CUI [4,3])
C0209227 (UMLS CUI [5,1])
C0205373 (UMLS CUI [5,2])
C0439590 (UMLS CUI [5,3])
C0209227 (UMLS CUI [6,1])
C0205373 (UMLS CUI [6,2])
C0332183 (UMLS CUI [6,3])
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