Eligibility Hepatitis C, Chronic Relapse NCT00299923

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Age
Item
Age 18 Years and older
boolean
C0001779 (UMLS CUI-1)
Relapsers to combination therapy with negative HCV-RNA test result at treatment's end and positive HCV-RNA test result during follow-up
Item
Relapsers to previous combination therapy with (PEG-)IFN alfa-/Ribavirin and a negative HCV-RNA test result at the end of this regular treatment course and positive HCV-RNA test result during the follow-up period.
boolean
C0277556 (UMLS CUI-1)
C0556895 (UMLS CUI-2)
C0369335 (UMLS CUI-3)
Termination of (PEG-)IFN alfa-/ribavirin therapy
Item
Termination of (PEG-)IFN alfa-/ribavirin therapy at least 3 months prior to enrolment
boolean
HCV infection genotype 1 or 3
Item
Chronic HCV infection genotype 1 or 3
boolean
quantitative HCV-RNA PCR test
Item
Serum HCV-RNA quantifiable at >100 IU/mL by COBAS AmpliPrep or another quantitative HCV-RNA PCR test (reported in IU)
boolean
liver disease (Child-Pugh A)
Item
Compensated liver disease (Child-Pugh A)
boolean
Exclusion of HCC in patients with cirrhosis
Item
Exclusion of HCC in patients with cirrhosis or transition to cirrhosis. In patients with AFP >50 ng/mL an established assay for exclusion of HCC has to be done
boolean
Negative pregnancy test
Item
Negative urine or blood pregnancy test
boolean
fertile males and females use two forms of contraception
Item
All fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months post treatment
boolean
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Hypersensitiveness to ingredient of the drugs
Item
Hypersensitiveness to Interferon, PEG-IFN alfa-2a, Ribavirin and Amantadine or other ingredient of the drugs
boolean
pregnancy or breast feeding
Item
Ongoing pregnancy or breast feeding
boolean
Male partners of women who are pregnant or without contraception
Item
Male partners of women who are pregnant or with women without effective contraception
boolean
hepatocellular carcinoma
Item
Signs or symptoms of hepatocellular carcinoma
boolean
HCV infection genotype 2, 4, 5 or 6
Item
Chronic HCV infection genotype 2, 4, 5 or 6
boolean
Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment. Exception: patients who have had a limited course of acyclovir or valacyclovir for herpetic lesions.
Item
Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment < 6 months prior to the first dose of study drug and during study period. Exception: patients who have had a limited (< 7 days) course of acyclovir or valacyclovir for herpetic lesions < 1 month prior to the first administration of test drug are not excluded.
boolean
investigational drug < 6 weeks prior to the study drug
Item
Any investigational drug < 6 weeks prior to the first dose of study drug
boolean
Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV
Item
Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV
boolean
chronic liver disease other than HCV
Item
History or other evidence of a medical condition associated with chronic liver disease other than HCV
boolean
decompensated liver disease or Child-Pugh score > 6
Item
History or other evidence of decompensated liver disease or a Child-Pugh score > 6.
boolean
Hemoglobin low
Item
Hb <12 g/dL (<120 g/L) in women or <13 g/dL (<130 g/L) in men at screening
boolean
C0162119 (UMLS CUI-1)
patient with risk for anemia or for whom anemia would be problematic
Item
Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic
boolean
Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3
Item
Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3
boolean
Serum creatinin concentration >1.5 mg/dl
Item
Serum creatinin concentration >1.5 mg/dl
boolean
severe psychiatric disease
Item
History of severe psychiatric disease, especially depression.
boolean
seizure disorder not stabilizable by medication
Item
History of a severe seizure disorder that can not be stabilized by medication
boolean
immunologically mediated disease
Item
History of immunologically mediated disease
boolean
Chronic pulmonary disease
Item
Chronic pulmonary disease associated with functional limitation
boolean
severe cardiac disease
Item
History of severe cardiac disease
boolean
major organ transplantation except corneatransplantation
Item
History of major organ transplantation except corneatransplantation
boolean
severe illness, malignancy, or any other conditions which would make the patient unsuitable for the study
Item
Evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
boolean
Thyroid dysfunction not adequately controlled
Item
Thyroid dysfunction not adequately controlled
boolean
severe retinopathy or ophthalmological disorder due to diabetes mellitus or hypertension
Item
Evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension
boolean
active drug abuse
Item
Evidence of active drug abuse within one year of study entry except of a prescribed stable opioid substitution
boolean
Take of Memantine
Item
Take of Memantine during study period
boolean
Cardiomyopathy and myocarditis
Item
Cardiomyopathy and myocarditis
boolean
AV-Block II and III
Item
AV-Block II and III
boolean
bradycardia < 55 counts/min
Item
Pre-existing bradycardia < 55 counts/min
boolean
QT-interval or U-waves or QT-syndrome
Item
Known QT-interval (QTc after Bazett > 420 ms) or recognized U-waves or congenital QT-syndrome
boolean
severe ventricular arrhythmia
Item
History of severe ventricular arrhythmia incl. Torsade de pointes
boolean
Simultaneous therapy with Budipin or other medicine that extend the QT-interval
Item
Simultaneous therapy with Budipin or other medicine that extend the QT-interval like (e.g.antiarrhythmic drugs class IA and class III, antipsychotic drugs, tri- and tetracyclic antidepressants, antihistaminics, macrolide, gyrase inhibitors, Azol-antimykotics)
boolean
obstructive glaucoma
Item
Patients with obstructive glaucoma
boolean
excitableness and confusion
Item
Patients with excitableness and confusion
boolean
delirium and exogenic psychosis in the anamnesis
Item
Patients with delirium and exogenic psychosis in the anamnesis
boolean
Prostataadenome
Item
Prostataadenome
boolean
medication of type combination Triamterene/ Hydrochlorothiazide
Item
Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide
boolean
lack of informed consent or of abidance by the study requirements
Item
Inability or unwillingness to provide informed consent or abide by the requirements of the study
boolean
Item Group
Medical Concepts
PEG
Item
Polyethylene Glycols
string
C0032483 (UMLS CUI)
8030004 (SNOMED CT 2010_0731)
IFN Alpha
Item
Interferon Alpha
string
C1610033 (UMLS CUI)
Ribavirin
Item
Ribavirin (substance)
string
C0035525 (UMLS CUI)
387188005 (SNOMED CT 2010_0731)
MTHU018696 (LOINC Version 232)
HCV RNA
Item
Hepatitis C virus RNA (substance)
string
C0369335 (UMLS CUI)
121204002 (SNOMED CT 2010_0731)
MTHU001816 (LOINC Version 232)
Test
Item
Test
string
C0392366 (UMLS CUI)
C47891 (SNOMED CT 2010_0731)
Negative
Item
Negative
string
CL415098 (UMLS CUI)
Therapy
Item
Treatment
string
C0087111 (UMLS CUI)
positive
Item
positive
string
CL415097 (UMLS CUI)
Follow-up
Item
Follow-up
string
C1522577 (UMLS CUI)
Period
Item
Period (temporal concept)
string
C1948053 (UMLS CUI)
Enrollment
Item
Enrolment, Registration
string
C2348568 (UMLS CUI)
HCV
Item
Hepatitis C virus
string
C0220847 (UMLS CUI)
62944002 (SNOMED CT 2010_0731)
10019752 (MedDRA 13.1)
chronic
Item
chronic
string
C0205191 (UMLS CUI)
90734009 (SNOMED CT 2010_0731)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
Genotype
Item
Genotype
string
C0017431 (UMLS CUI)
Serum
Item
Serum (substance)
string
C0229671 (UMLS CUI)
67922002 (SNOMED CT 2010_0731)
MTHU001009 (LOINC Version 232)
IU
Item
International Units (qualifier value)
string
C0439453 (UMLS CUI)
258997004 (SNOMED CT 2010_0731)
[IU] (HL7 V3 02-34)
PCR
Item
Polymerase Chain Reaction
string
C0032520 (UMLS CUI)
258066000 (SNOMED CT 2010_0731)
10050967 (MedDRA 13.1)
132 (HL7 V3 02-34)
Quantitative
Item
Quantitative (qualifier value)
string
C0392762 (UMLS CUI)
30766002 (SNOMED CT 2010_0731)
Liver disorder
Item
Liver diseases
string
C0023895 (UMLS CUI)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Child-Pugh Classification
Item
Child-Pugh Score
string
C2347612 (UMLS CUI)
HCC
Item
Hepatocellular Carcinoma
string
C0019204 (UMLS CUI)
10049010 (MedDRA 13.1)
Hepatic Cirrhosis
Item
Liver Cirrhosis
string
C0023890 (UMLS CUI)
19943007 (SNOMED CT 2010_0731)
10019641 (MedDRA 13.1)
K74.60 (ICD-10-CM Version 2010)
AFP measurement
Item
Alpha-1-fetoprotein Measurement
string
C0201539 (UMLS CUI)
80152001 (SNOMED CT 2010_0731)
10001455 (MedDRA 13.1)
Assay
Item
Assay technique
string
C1510438 (UMLS CUI)
272392009 (SNOMED CT 2010_0731)
Urine pregnancy test negative
Item
Urine pregnancy test negative
string
C0430057 (UMLS CUI)
167254001 (SNOMED CT 2010_0731)
10036577 (MedDRA 13.1)
Negative Pregnancy Test
Item
Negative Pregnancy Test
string
C0427780 (UMLS CUI)
250425007 (SNOMED CT 2010_0731)
10036574 (MedDRA 13.1)
blood
Item
blood
string
C0005768 (UMLS CUI)
Fertile
Item
Fertile
string
CL426012 (UMLS CUI)
Male
Item
Male gender
string
C0024554 (UMLS CUI)
Female
Item
Female Gender
string
C0015780 (UMLS CUI)
Contraception
Item
Contraception, Birth control
string
C0700589 (UMLS CUI)
146680009 (SNOMED CT 2010_0731)
10010808 (MedDRA 13.1)
Hypersensitivity
Item
Allergic reaction to substance
string
C0020517 (UMLS CUI)
418634005 (SNOMED CT 2010_0731)
T78.40 (ICD-10-CM Version 2010)
Interferons
Item
Interferon (substance)
string
C0021747 (UMLS CUI)
49327004 (SNOMED CT 2010_0731)
MTHU021353 (LOINC Version 232)
peginterferon alfa-2a
Item
Peginterferon alpha-2a (substance)
string
C0391001 (UMLS CUI)
421559001 (SNOMED CT 2010_0731)
Amantadine
Item
Amantadine (substance)
string
C0002403 (UMLS CUI)
372763006 (SNOMED CT 2010_0731)
MTHU006774 (LOINC Version 232)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Pregnancy
Item
Pregnancy, Gestation
string
C0549206 (UMLS CUI)
289908002 (SNOMED CT 2010_0731)
10036556 (MedDRA 13.1)
MTHU035048 (LOINC Version 232)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
signs
Item
signs
string
C0220912 (UMLS CUI)
Symptoms
Item
Symptoms
string
C1457887 (UMLS CUI)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Systemic Therapy
Item
Systemic Therapy
string
C1515119 (UMLS CUI)
Antiviral treatment
Item
Antiviral treatment
string
C2363964 (UMLS CUI)
10068724 (MedDRA 13.1)
antineoplastic Immunotherapy
Item
Immunotherapy, antineoplastic
string
C0864561 (UMLS CUI)
Immunomodulatory or immunosuppressive therapy
Item
Immunomodulatory or immunosuppressive therapy
string
C1963758 (UMLS CUI)
86553008 (SNOMED CT 2010_0731)
10067473 (MedDRA 13.1)
Acyclovir
Item
Acyclovir (substance)
string
C0001367 (UMLS CUI)
372729009 (SNOMED CT 2010_0731)
MTHU006764 (LOINC Version 232)
Valaciclovir
Item
Valacyclovir (substance)
string
C0249458 (UMLS CUI)
96098007 (SNOMED CT 2010_0731)
Herpes dermatitis
Item
eczema herpeticum
string
C1262170 (UMLS CUI)
10062639 (MedDRA 13.1)
Investigational Drug
Item
Investigational New Drug
string
C0013230 (UMLS CUI)
HAV
Item
Hepatitis A Virus
string
C0376325 (UMLS CUI)
32452004 (SNOMED CT 2010_0731)
IgM
Item
Immunoglobulin M
string
C0020861 (UMLS CUI)
74889000 (SNOMED CT 2010_0731)
MTHU004563 (LOINC Version 232)
HBsAg
Item
Hepatitis B Surface Antigens
string
C0019168 (UMLS CUI)
22290004 (SNOMED CT 2010_0731)
MTHU001814 (LOINC Version 232)
HBc IgM
Item
Hepatitis B core IgM level
string
C1277836 (UMLS CUI)
315132007 (SNOMED CT 2010_0731)
HIV
Item
Human immunodeficiency virus
string
C0019699 (UMLS CUI)
19030005 (SNOMED CT 2010_0731)
Decompensated Liver Disease
Item
End Stage Liver Disease
string
C0745744 (UMLS CUI)
10050060 (MedDRA 13.1)
man
Item
Male population group
string
C0025266 (UMLS CUI)
339947000 (SNOMED CT 2010_0731)
Woman
Item
Human, Female
string
C0043210 (UMLS CUI)
224526002 (SNOMED CT 2010_0731)
disorder risk
Item
disease risk
string
C0683481 (UMLS CUI)
Anemia
Item
Anaemia
string
C0002871 (UMLS CUI)
271737000 (SNOMED CT 2010_0731)
10002034 (MedDRA 13.1)
MTHU020823 (LOINC Version 232)
D64.9 (ICD-10-CM Version 2010)
285.9 (ICD-9-CM Version 2011)
E10010 (CTCAE Version 4.03)
Baseline
Item
Baseline
string
C1442488 (UMLS CUI)
Neutrophil count
Item
Neutrophil count (procedure)
string
C0200633 (UMLS CUI)
30630007 (SNOMED CT 2010_0731)
10029363 (MedDRA 13.1)
Platelet count
Item
Platelet count - finding
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Serum Creatinine
Item
Serum Creatinine Measurement
string
C0201976 (UMLS CUI)
113075003 (SNOMED CT 2010_0731)
10040230 (MedDRA 13.1)
Concentration
Item
Concentration
string
C1446561 (UMLS CUI)
Mental disorders
Item
Psychiatric disorder
string
C0004936 (UMLS CUI)
74732009 (SNOMED CT 2010_0731)
10037174 (MedDRA 13.1)
F99 (ICD-10-CM Version 2010)
290-319.99 (ICD-9-CM Version 2011)
Depressive disorder
Item
Depression
string
C0011581 (UMLS CUI)
35489007 (SNOMED CT 2010_0731)
10012401 (MedDRA 13.1)
F32.9 (ICD-10-CM Version 2010)
Epilepsy
Item
Epilepsia
string
C0014544 (UMLS CUI)
84757009 (SNOMED CT 2010_0731)
10015037 (MedDRA 13.1)
MTHU020586 (LOINC Version 232)
G40.9 (ICD-10-CM Version 2010)
345.9 (ICD-9-CM Version 2011)
Stabilization
Item
Stabilization (procedure)
string
C1293130 (UMLS CUI)
115979005 (SNOMED CT 2010_0731)
Immunotherapy
Item
Immunotherapy
string
C0021083 (UMLS CUI)
146638005 (SNOMED CT 2010_0731)
Pulmonary disease
Item
Lung diseases
string
C0024115 (UMLS CUI)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)
Limitation
Item
Limitation (attribute)
string
C0449295 (UMLS CUI)
246175000 (SNOMED CT 2010_0731)
Functional Status
Item
Functional Status, Level of function
string
C0598463 (UMLS CUI)
MTHU027728 (LOINC Version 232)
Cardiac disease
Item
Cardiac disease
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
Organ Transplantation
Item
Organ Transplantation
string
C0029216 (UMLS CUI)
10061890 (MedDRA 13.1)
MTHU000173 (LOINC Version 232)
Major
Item
Major (qualifier value)
string
C0205164 (UMLS CUI)
255603008 (SNOMED CT 2010_0731)
Keratoplasty
Item
Corneal transplant (procedure)
string
C0010042 (UMLS CUI)
60656008 (SNOMED CT 2010_0731)
10054846 (MedDRA 13.1)
11.60 (ICD-9-CM Version 2011)
Disease
Item
disorder
string
C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
Cancer
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
363346000 (SNOMED CT 2010_0731)
10028997 (MedDRA 13.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
Thyroid dysfunction
Item
Thyroid dysfunction
string
C0348024 (UMLS CUI)
264580006 (SNOMED CT 2010_0731)
10013907 (MedDRA 13.1)
Retinopathy
Item
Retinopathy
string
C0035309 (UMLS CUI)
399625000 (SNOMED CT 2010_0731)
10038923 (MedDRA 13.1)
E10432 (CTCAE Version 4.03)
Disorder of eye
Item
Ophthalmological disorder
string
C0015397 (UMLS CUI)
371405004 (SNOMED CT 2010_0731)
10015916 (MedDRA 13.1)
H44 (ICD-10-CM Version 2010)
379.90 (ICD-9-CM Version 2011)
Diabetes mellitus
Item
Diabetes mellitus
string
C0011849 (UMLS CUI)
191044006 (SNOMED CT 2010_0731)
Hypertension
Item
Hypertensive disease, High Blood Pressure
string
C0020538 (UMLS CUI)
38341003 (SNOMED CT 2010_0731)
10020772 (MedDRA 13.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE Version 4.03)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
26416006 (SNOMED CT 2010_0731)
10013654 (MedDRA 13.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
Active
Item
Active (qualifier value)
string
C0205177 (UMLS CUI)
55561003 (SNOMED CT 2010_0731)
Prescriptions
Item
Prescription (procedure)
string
C0033080 (UMLS CUI)
16076005 (SNOMED CT 2010_0731)
Opioid Rotation
Item
Opioid Substitution
string
C1518592 (UMLS CUI)
Stable status
Item
Stability
string
C0205360 (UMLS CUI)
58158008 (SNOMED CT 2010_0731)
MTHU015276 (LOINC Version 232)
Memantine
Item
Memantine (substance)
string
C0025242 (UMLS CUI)
406458000 (SNOMED CT 2010_0731)
MTHU035864 (LOINC Version 232)
Take
Item
Take- dosing instruction imperative (qualifier value)
string
C1515187 (UMLS CUI)
419652001 (SNOMED CT 2010_0731)
Cardiomyopathy
Item
Cardiomyopathy
string
C0878544 (UMLS CUI)
85898001 (SNOMED CT 2010_0731)
10007636 (MedDRA 13.1)
I42.9 (ICD-10-CM Version 2010)
425 (ICD-9-CM Version 2011)
Myocarditis
Item
Myocarditis
string
C0027059 (UMLS CUI)
50920009 (SNOMED CT 2010_0731)
10028606 (MedDRA 13.1)
I51.4 (ICD-10-CM Version 2010)
429.0 (ICD-9-CM Version 2011)
E10157 (CTCAE Version 4.03)
AV Block
Item
Atrioventricular Block
string
C0004245 (UMLS CUI)
233917008 (SNOMED CT 2010_0731)
10003671 (MedDRA 13.1)
I44.30 (ICD-10-CM Version 2010)
426.10 (ICD-9-CM Version 2011)
Bradycardia
Item
Decreased heart rate
string
C0428977 (UMLS CUI)
48867003 (SNOMED CT 2010_0731)
10006093 (MedDRA 13.1)
R00.1 (ICD-10-CM Version 2010)
QTC interval
Item
QTC interval
string
C0489625 (UMLS CUI)
MTHU024527 (LOINC Version 232)
QT interval - finding
Item
Finding of ECG QT interval (finding)
string
C1287082 (UMLS CUI)
365417009 (SNOMED CT 2010_0731)
U Waves
Item
U wave feature (observable entity)
string
C0232333 (UMLS CUI)
39438000 (SNOMED CT 2010_0731)
10045281 (MedDRA 13.1)
Syndrome
Item
Syndrome
string
C0039082 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
congenital
Item
congenital
string
C0009678 (UMLS CUI)
Ventricular arrhythmia
Item
Ventricular arrhythmia
string
C0085612 (UMLS CUI)
44103008 (SNOMED CT 2010_0731)
10047281 (MedDRA 13.1)
I49.01 (ICD-10-CM Version 2010)
E10230 (CTCAE Version 4.03)
Torsades de Pointes
Item
Ventricular tachycardia, polymorphic with Q-T prolongation
string
C0040479 (UMLS CUI)
31722008 (SNOMED CT 2010_0731)
10044066 (MedDRA 13.1)
Simultaneous
Item
Simultaneous (qualifier value)
string
C0521115 (UMLS CUI)
79970003 (SNOMED CT 2010_0731)
Budipine
Item
1-(1,1-Dimethylethyl)-4,4-diphenylpiperidine
string
C0054202 (UMLS CUI)
Antiarrhythmic drug
Item
Antiarrhythmic drug
string
C0003195 (UMLS CUI)
67507000 (SNOMED CT 2010_0731)
Antipsychotic Agent
Item
Antipsychotic agent (substance)
string
C0040615 (UMLS CUI)
372482001 (SNOMED CT 2010_0731)
MTHU003337 (LOINC Version 232)
Tricyclic antidepressant
Item
Tricyclic Antidepressive Agents
string
C0003290 (UMLS CUI)
373253007 (SNOMED CT 2010_0731)
MTHU001920 (LOINC Version 232)
Tetracyclic antidepressant
Item
Tetracyclic antidepressant (substance)
string
C0360108 (UMLS CUI)
372576002 (SNOMED CT 2010_0731)
Antihistamines
Item
antihistaminics
string
C0003360 (UMLS CUI)
372806008 (SNOMED CT 2010_0731)
MTHU003328 (LOINC Version 232)
Macrolides
Item
Macrolide (substance)
string
C0282563 (UMLS CUI)
428787002 (SNOMED CT 2010_0731)
DNA Gyrase Inhibitors
Item
DNA Gyrase Inhibitors [MoA]
string
C2936780 (UMLS CUI)
Azole antifungal
Item
Azole antifungal (substance)
string
C0360363 (UMLS CUI)
373236000 (SNOMED CT 2010_0731)
Glaucoma
Item
Glaucoma
string
C0017601 (UMLS CUI)
23986001 (SNOMED CT 2010_0731)
10018304 (MedDRA 13.1)
MTHU020819 (LOINC Version 232)
H40-H42 (ICD-10-CM Version 2010)
365 (ICD-9-CM Version 2011)
E10392 (CTCAE Version 4.03)
obstructive glaucoma
Item
Angle Closure Glaucoma
string
C0017605 (UMLS CUI)
392291006 (SNOMED CT 2010_0731)
10002500 (MedDRA 13.1)
Excitable
Item
Excitable
string
C0857393 (UMLS CUI)
10015623 (MedDRA 13.1)
Confusion
Item
Confusional state (disorder)
string
C0009676 (UMLS CUI)
286933003 (SNOMED CT 2010_0731)
10010305 (MedDRA 13.1)
MTHU019384 (LOINC Version 232)
R41.0 (ICD-10-CM Version 2010)
E12889 (CTCAE Version 4.03)
Delirium
Item
Delirium (disorder)
string
C0011206 (UMLS CUI)
2776000 (SNOMED CT 2010_0731)
10012218 (MedDRA 13.1)
MTHU031955 (LOINC Version 232)
R41.0 (ICD-10-CM Version 2010)
E12898 (CTCAE Version 4.03)
Psychotic Disorders
Item
Psychosis (Psychotic disorder)
string
C0033975 (UMLS CUI)
69322001 (SNOMED CT 2010_0731)
10061920 (MedDRA 13.1)
290-299.99 (ICD-9-CM Version 2011)
E12954 (CTCAE Version 4.03)
exogen
Item
exogen
string
C1752469 (UMLS CUI)
Anamnesis
Item
Immunologic Memory
string
C0021055 (UMLS CUI)
940000 (SNOMED CT 2010_0731)
Prostatic Hyperplasia
Item
Hyperplasia of prostate
string
C2937421 (UMLS CUI)
433234005 (SNOMED CT 2010_0731)
10020728 (MedDRA 13.1)
N40 (ICD-10-CM Version 2010)
600 (ICD-9-CM Version 2011)
Diuretic
Item
Diuretic (substance)
string
C0012798 (UMLS CUI)
372695000 (SNOMED CT 2010_0731)
MTHU003217 (LOINC Version 232)
Triamterene
Item
Triamterene (substance)
string
C0040869 (UMLS CUI)
387053007 (SNOMED CT 2010_0731)
MTHU001919 (LOINC Version 232)
Hydrochlorothiazide
Item
Hydrochlorothiazide (substance)
string
C0020261 (UMLS CUI)
387525002 (SNOMED CT 2010_0731)
MTHU016732 (LOINC Version 232)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Requirement
Item
Requirement
string
C1514873 (UMLS CUI)
Study
Item
Clinical Trials
string
C0008976 (UMLS CUI)
110465008 (SNOMED CT 2010_0731)

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