ID

43272

Description

ODM derived from http://clinicaltrials.gov/show/NCT00299923 Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy

Link

http://clinicaltrials.gov/show/NCT00299923

Keywords

  1. 3/12/12 3/12/12 -
  2. 4/13/14 4/13/14 - Julian Varghese
  3. 6/11/15 6/11/15 - Martin Dugas
  4. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0

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Hepatitis C Eligibility NCT00299923

Eligibility Hepatitis C, Chronic Relapse NCT00299923

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Age 18 Years and older
Description

Age

Data type

boolean

Alias
UMLS CUI-1
C0001779
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.
Description

Relapsers to combination therapy with negative HCV-RNA test result at treatment's end and positive HCV-RNA test result during follow-up

Data type

boolean

Alias
UMLS CUI-1
C0277556
UMLS CUI-2
C0556895
UMLS CUI-3
C0369335
Termination of (PEG-)IFN alfa-/ribavirin therapy at least 3 months prior to enrolment
Description

Termination of (PEG-)IFN alfa-/ribavirin therapy

Data type

boolean

Chronic HCV infection genotype 1 or 3
Description

HCV infection genotype 1 or 3

Data type

boolean

Serum HCV-RNA quantifiable at >100 IU/mL by COBAS AmpliPrep or another quantitative HCV-RNA PCR test (reported in IU)
Description

quantitative HCV-RNA PCR test

Data type

boolean

Compensated liver disease (Child-Pugh A)
Description

liver disease (Child-Pugh A)

Data type

boolean

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
Description

Exclusion of HCC in patients with cirrhosis

Data type

boolean

Negative urine or blood pregnancy test
Description

Negative pregnancy test

Data type

boolean

All fertile males and females must use two reliable forms of effective contraception (combined) during treatment with study drugs and 6 months post treatment
Description

fertile males and females use two forms of contraception

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Hypersensitiveness to Interferon, PEG-IFN alfa-2a, Ribavirin and Amantadine or other ingredient of the drugs
Description

Hypersensitiveness to ingredient of the drugs

Data type

boolean

Ongoing pregnancy or breast feeding
Description

pregnancy or breast feeding

Data type

boolean

Male partners of women who are pregnant or with women without effective contraception
Description

Male partners of women who are pregnant or without contraception

Data type

boolean

Signs or symptoms of hepatocellular carcinoma
Description

hepatocellular carcinoma

Data type

boolean

Chronic HCV infection genotype 2, 4, 5 or 6
Description

HCV infection genotype 2, 4, 5 or 6

Data type

boolean

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.
Description

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.

Data type

boolean

Any investigational drug < 6 weeks prior to the first dose of study drug
Description

investigational drug < 6 weeks prior to the study drug

Data type

boolean

Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV
Description

Positive test for anti-HAV IgM, HBsAg, anti-HBc IgM, anti-HIV

Data type

boolean

History or other evidence of a medical condition associated with chronic liver disease other than HCV
Description

chronic liver disease other than HCV

Data type

boolean

History or other evidence of decompensated liver disease or a Child-Pugh score > 6.
Description

decompensated liver disease or Child-Pugh score > 6

Data type

boolean

Hb <12 g/dL (<120 g/L) in women or <13 g/dL (<130 g/L) in men at screening
Description

Hemoglobin low

Data type

boolean

Alias
UMLS CUI-1
C0162119
Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic
Description

patient with risk for anemia or for whom anemia would be problematic

Data type

boolean

Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3
Description

Neutrophil count <1,500 cells/mm3 and/or platelet count <90,000 cells/mm3

Data type

boolean

Serum creatinin concentration >1.5 mg/dl
Description

Serum creatinin concentration >1.5 mg/dl

Data type

boolean

History of severe psychiatric disease, especially depression.
Description

severe psychiatric disease

Data type

boolean

History of a severe seizure disorder that can not be stabilized by medication
Description

seizure disorder not stabilizable by medication

Data type

boolean

History of immunologically mediated disease
Description

immunologically mediated disease

Data type

boolean

Chronic pulmonary disease associated with functional limitation
Description

Chronic pulmonary disease

Data type

boolean

History of severe cardiac disease
Description

severe cardiac disease

Data type

boolean

History of major organ transplantation except corneatransplantation
Description

major organ transplantation except corneatransplantation

Data type

boolean

Evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Description

severe illness, malignancy, or any other conditions which would make the patient unsuitable for the study

Data type

boolean

Thyroid dysfunction not adequately controlled
Description

Thyroid dysfunction not adequately controlled

Data type

boolean

Evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension
Description

severe retinopathy or ophthalmological disorder due to diabetes mellitus or hypertension

Data type

boolean

Evidence of active drug abuse within one year of study entry except of a prescribed stable opioid substitution
Description

active drug abuse

Data type

boolean

Take of Memantine during study period
Description

Take of Memantine

Data type

boolean

Cardiomyopathy and myocarditis
Description

Cardiomyopathy and myocarditis

Data type

boolean

AV-Block II and III
Description

AV-Block II and III

Data type

boolean

Pre-existing bradycardia < 55 counts/min
Description

bradycardia < 55 counts/min

Data type

boolean

Known QT-interval (QTc after Bazett > 420 ms) or recognized U-waves or congenital QT-syndrome
Description

QT-interval or U-waves or QT-syndrome

Data type

boolean

History of severe ventricular arrhythmia incl. Torsade de pointes
Description

severe ventricular arrhythmia

Data type

boolean

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)
Description

Simultaneous therapy with Budipin or other medicine that extend the QT-interval

Data type

boolean

Patients with obstructive glaucoma
Description

obstructive glaucoma

Data type

boolean

Patients with excitableness and confusion
Description

excitableness and confusion

Data type

boolean

Patients with delirium and exogenic psychosis in the anamnesis
Description

delirium and exogenic psychosis in the anamnesis

Data type

boolean

Prostataadenome
Description

Prostataadenome

Data type

boolean

Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide
Description

medication of type combination Triamterene/ Hydrochlorothiazide

Data type

boolean

Inability or unwillingness to provide informed consent or abide by the requirements of the study
Description

lack of informed consent or of abidance by the study requirements

Data type

boolean

Medical Concepts
Description

Medical Concepts

Polyethylene Glycols
Description

PEG

Data type

string

Alias
UMLS CUI
C0032483
SNOMED CT 2010_0731
8030004
Interferon Alpha
Description

IFN Alpha

Data type

string

Alias
UMLS CUI
C1610033
Ribavirin (substance)
Description

Ribavirin

Data type

string

Alias
UMLS CUI
C0035525
SNOMED CT 2010_0731
387188005
LOINC Version 232
MTHU018696
Hepatitis C virus RNA (substance)
Description

HCV RNA

Data type

string

Alias
UMLS CUI
C0369335
SNOMED CT 2010_0731
121204002
LOINC Version 232
MTHU001816
Test
Description

Test

Data type

string

Alias
UMLS CUI
C0392366
SNOMED CT 2010_0731
C47891
Negative
Description

Negative

Data type

string

Alias
UMLS CUI
CL415098
Treatment
Description

Therapy

Data type

string

Alias
UMLS CUI
C0087111
positive
Description

positive

Data type

string

Alias
UMLS CUI
CL415097
Follow-up
Description

Follow-up

Data type

string

Alias
UMLS CUI
C1522577
Period (temporal concept)
Description

Period

Data type

string

Alias
UMLS CUI
C1948053
Enrolment, Registration
Description

Enrollment

Data type

string

Alias
UMLS CUI
C2348568
Hepatitis C virus
Description

HCV

Data type

string

Alias
UMLS CUI
C0220847
SNOMED CT 2010_0731
62944002
MedDRA 13.1
10019752
chronic
Description

chronic

Data type

string

Alias
UMLS CUI
C0205191
SNOMED CT 2010_0731
90734009
Infection
Description

Infection

Data type

string

Alias
UMLS CUI
C0009450
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Genotype
Description

Genotype

Data type

string

Alias
UMLS CUI
C0017431
Serum (substance)
Description

Serum

Data type

string

Alias
UMLS CUI
C0229671
SNOMED CT 2010_0731
67922002
LOINC Version 232
MTHU001009
International Units (qualifier value)
Description

IU

Data type

string

Alias
UMLS CUI
C0439453
SNOMED CT 2010_0731
258997004
HL7 V3 02-34
[IU]
Polymerase Chain Reaction
Description

PCR

Data type

string

Alias
UMLS CUI
C0032520
SNOMED CT 2010_0731
258066000
MedDRA 13.1
10050967
HL7 V3 02-34
132
Quantitative (qualifier value)
Description

Quantitative

Data type

string

Alias
UMLS CUI
C0392762
SNOMED CT 2010_0731
30766002
Liver diseases
Description

Liver disorder

Data type

string

Alias
UMLS CUI
C0023895
SNOMED CT 2010_0731
235856003
MedDRA 13.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Child-Pugh Score
Description

Child-Pugh Classification

Data type

string

Alias
UMLS CUI
C4050412
Hepatocellular Carcinoma
Description

HCC

Data type

string

Alias
UMLS CUI
C2239176
MedDRA 13.1
10049010
Liver Cirrhosis
Description

Hepatic Cirrhosis

Data type

string

Alias
UMLS CUI
C0023890
SNOMED CT 2010_0731
19943007
MedDRA 13.1
10019641
ICD-10-CM Version 2010
K74.60
Alpha-1-fetoprotein Measurement
Description

AFP measurement

Data type

string

Alias
UMLS CUI
C0201539
SNOMED CT 2010_0731
80152001
MedDRA 13.1
10001455
Assay technique
Description

Assay

Data type

string

Alias
UMLS CUI
C1510438
SNOMED CT 2010_0731
272392009
Urine pregnancy test negative
Description

Urine pregnancy test negative

Data type

string

Alias
UMLS CUI
C0430057
SNOMED CT 2010_0731
167254001
MedDRA 13.1
10036577
Negative Pregnancy Test
Description

Negative Pregnancy Test

Data type

string

Alias
UMLS CUI
C0427780
SNOMED CT 2010_0731
250425007
MedDRA 13.1
10036574
blood
Description

blood

Data type

string

Alias
UMLS CUI
C0005768
Fertile
Description

Fertile

Data type

string

Alias
UMLS CUI
CL426012
Male gender
Description

Male

Data type

string

Alias
UMLS CUI
C0086582
Female Gender
Description

Female

Data type

string

Alias
UMLS CUI
C0086287
Contraception, Birth control
Description

Contraception

Data type

string

Alias
UMLS CUI
C0700589
SNOMED CT 2010_0731
146680009
MedDRA 13.1
10010808
Allergic reaction to substance
Description

Hypersensitivity

Data type

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
418634005
ICD-10-CM Version 2010
T78.40
Interferon (substance)
Description

Interferons

Data type

string

Alias
UMLS CUI
C0021747
SNOMED CT 2010_0731
49327004
LOINC Version 232
MTHU021353
Peginterferon alpha-2a (substance)
Description

peginterferon alfa-2a

Data type

string

Alias
UMLS CUI
C0391001
SNOMED CT 2010_0731
421559001
Amantadine (substance)
Description

Amantadine

Data type

string

Alias
UMLS CUI
C0002403
SNOMED CT 2010_0731
372763006
LOINC Version 232
MTHU006774
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
Pregnancy, Gestation
Description

Pregnancy

Data type

string

Alias
UMLS CUI
C0549206
SNOMED CT 2010_0731
289908002
MedDRA 13.1
10036556
LOINC Version 232
MTHU035048
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding, Nursing
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
signs
Description

signs

Data type

string

Alias
UMLS CUI
C0220912
Symptoms
Description

Symptoms

Data type

string

Alias
UMLS CUI
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
Systemic Therapy
Description

Systemic Therapy

Data type

string

Alias
UMLS CUI
C1515119
Antiviral treatment
Description

Antiviral treatment

Data type

string

Alias
UMLS CUI
C2363964
MedDRA 13.1
10068724
Immunotherapy, antineoplastic
Description

antineoplastic Immunotherapy

Data type

string

Alias
UMLS CUI
C0864561
Immunomodulatory or immunosuppressive therapy
Description

Immunomodulatory or immunosuppressive therapy

Data type

string

Alias
UMLS CUI
C1963758
SNOMED CT 2010_0731
86553008
MedDRA 13.1
10067473
Acyclovir (substance)
Description

Acyclovir

Data type

string

Alias
UMLS CUI
C0001367
SNOMED CT 2010_0731
372729009
LOINC Version 232
MTHU006764
Valacyclovir (substance)
Description

Valaciclovir

Data type

string

Alias
UMLS CUI
C0249458
SNOMED CT 2010_0731
96098007
eczema herpeticum
Description

Herpes dermatitis

Data type

string

Alias
UMLS CUI
C1262170
MedDRA 13.1
10062639
Investigational New Drug
Description

Investigational Drug

Data type

string

Alias
UMLS CUI
C0013230
Hepatitis A Virus
Description

HAV

Data type

string

Alias
UMLS CUI
C0376325
SNOMED CT 2010_0731
32452004
Immunoglobulin M
Description

IgM

Data type

string

Alias
UMLS CUI
C0020861
SNOMED CT 2010_0731
74889000
LOINC Version 232
MTHU004563
Hepatitis B Surface Antigens
Description

HBsAg

Data type

string

Alias
UMLS CUI
C0019168
SNOMED CT 2010_0731
22290004
LOINC Version 232
MTHU001814
Hepatitis B core IgM level
Description

HBc IgM

Data type

string

Alias
UMLS CUI
C1277836
SNOMED CT 2010_0731
315132007
Human immunodeficiency virus
Description

HIV

Data type

string

Alias
UMLS CUI
C0019699
SNOMED CT 2010_0731
19030005
End Stage Liver Disease
Description

Decompensated Liver Disease

Data type

string

Alias
UMLS CUI
C0745744
MedDRA 13.1
10050060
Male population group
Description

man

Data type

string

Alias
UMLS CUI
C0025266
SNOMED CT 2010_0731
339947000
Human, Female
Description

Woman

Data type

string

Alias
UMLS CUI
C0043210
SNOMED CT 2010_0731
224526002
disease risk
Description

disorder risk

Data type

string

Alias
UMLS CUI
C1281905
Anaemia
Description

Anemia

Data type

string

Alias
UMLS CUI
C0002871
SNOMED CT 2010_0731
271737000
MedDRA 13.1
10002034
LOINC Version 232
MTHU020823
ICD-10-CM Version 2010
D64.9
ICD-9-CM Version 2011
285.9
CTCAE Version 4.03
E10010
Baseline
Description

Baseline

Data type

string

Alias
UMLS CUI
C1442488
Neutrophil count (procedure)
Description

Neutrophil count

Data type

string

Alias
UMLS CUI
C0200633
SNOMED CT 2010_0731
30630007
MedDRA 13.1
10029363
Platelet count - finding
Description

Platelet count

Data type

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
Serum Creatinine Measurement
Description

Serum Creatinine

Data type

string

Alias
UMLS CUI
C0201976
SNOMED CT 2010_0731
113075003
MedDRA 13.1
10040230
Concentration
Description

Concentration

Data type

string

Alias
UMLS CUI
C1446561
Psychiatric disorder
Description

Mental disorders

Data type

string

Alias
UMLS CUI
C0004936
SNOMED CT 2010_0731
74732009
MedDRA 13.1
10037174
ICD-10-CM Version 2010
F99
ICD-9-CM Version 2011
290-319.99
Depression
Description

Depressive disorder

Data type

string

Alias
UMLS CUI
C0011581
SNOMED CT 2010_0731
35489007
MedDRA 13.1
10012401
ICD-10-CM Version 2010
F32.9
Epilepsia
Description

Epilepsy

Data type

string

Alias
UMLS CUI
C0014544
SNOMED CT 2010_0731
84757009
MedDRA 13.1
10015037
LOINC Version 232
MTHU020586
ICD-10-CM Version 2010
G40.9
ICD-9-CM Version 2011
345.9
Stabilization (procedure)
Description

Stabilization

Data type

string

Alias
UMLS CUI
C1293130
SNOMED CT 2010_0731
115979005
Immunotherapy
Description

Immunotherapy

Data type

string

Alias
UMLS CUI
C0021083
SNOMED CT 2010_0731
146638005
Lung diseases
Description

Pulmonary disease

Data type

string

Alias
UMLS CUI
C0024115
SNOMED CT 2010_0731
19829001
MedDRA 13.1
10025082
ICD-10-CM Version 2010
J98.4
Limitation (attribute)
Description

Limitation

Data type

string

Alias
UMLS CUI
C0449295
SNOMED CT 2010_0731
246175000
Functional Status, Level of function
Description

Functional Status

Data type

string

Alias
UMLS CUI
C0598463
LOINC Version 232
MTHU027728
Cardiac disease
Description

Cardiac disease

Data type

string

Alias
UMLS CUI
C0018799
SNOMED CT 2010_0731
56265001
MedDRA 13.1
10061024
Organ Transplantation
Description

Organ Transplantation

Data type

string

Alias
UMLS CUI
C0029216
MedDRA 13.1
10061890
LOINC Version 232
MTHU000173
Major (qualifier value)
Description

Major

Data type

string

Alias
UMLS CUI
C0205164
SNOMED CT 2010_0731
255603008
Corneal transplant (procedure)
Description

Keratoplasty

Data type

string

Alias
UMLS CUI
C0010042
SNOMED CT 2010_0731
60656008
MedDRA 13.1
10054846
ICD-9-CM Version 2011
11.60
disorder
Description

Disease

Data type

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
Malignant Neoplasms
Description

Cancer

Data type

string

Alias
UMLS CUI
C0006826
SNOMED CT 2010_0731
363346000
MedDRA 13.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
Thyroid dysfunction
Description

Thyroid dysfunction

Data type

string

Alias
UMLS CUI
C0348024
SNOMED CT 2010_0731
264580006
MedDRA 13.1
10013907
Retinopathy
Description

Retinopathy

Data type

string

Alias
UMLS CUI
C0035309
SNOMED CT 2010_0731
399625000
MedDRA 13.1
10038923
CTCAE Version 4.03
E10432
Ophthalmological disorder
Description

Disorder of eye

Data type

string

Alias
UMLS CUI
C0015397
SNOMED CT 2010_0731
371405004
MedDRA 13.1
10015916
ICD-10-CM Version 2010
H44
ICD-9-CM Version 2011
379.90
Diabetes mellitus
Description

Diabetes mellitus

Data type

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
Hypertensive disease, High Blood Pressure
Description

Hypertension

Data type

string

Alias
UMLS CUI
C0020538
SNOMED CT 2010_0731
38341003
MedDRA 13.1
10020772
LOINC Version 232
MTHU020789
ICD-10-CM Version 2010
I10
ICD-9-CM Version 2011
997.91
CTCAE Version 4.03
E13785
Drug abuse
Description

Drug abuse

Data type

string

Alias
UMLS CUI
C0013146
SNOMED CT 2010_0731
26416006
MedDRA 13.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
Active (qualifier value)
Description

Active

Data type

string

Alias
UMLS CUI
C0205177
SNOMED CT 2010_0731
55561003
Prescription (procedure)
Description

Prescriptions

Data type

string

Alias
UMLS CUI
C0033080
SNOMED CT 2010_0731
16076005
Opioid Substitution
Description

Opioid Rotation

Data type

string

Alias
UMLS CUI
C1518592
Stability
Description

Stable status

Data type

string

Alias
UMLS CUI
C0205360
SNOMED CT 2010_0731
58158008
LOINC Version 232
MTHU015276
Memantine (substance)
Description

Memantine

Data type

string

Alias
UMLS CUI
C0025242
SNOMED CT 2010_0731
406458000
LOINC Version 232
MTHU035864
Take- dosing instruction imperative (qualifier value)
Description

Take

Data type

string

Alias
UMLS CUI
C1515187
SNOMED CT 2010_0731
419652001
Cardiomyopathy
Description

Cardiomyopathy

Data type

string

Alias
UMLS CUI
C0878544
SNOMED CT 2010_0731
85898001
MedDRA 13.1
10007636
ICD-10-CM Version 2010
I42.9
ICD-9-CM Version 2011
425
Myocarditis
Description

Myocarditis

Data type

string

Alias
UMLS CUI
C0027059
SNOMED CT 2010_0731
50920009
MedDRA 13.1
10028606
ICD-10-CM Version 2010
I51.4
ICD-9-CM Version 2011
429.0
CTCAE Version 4.03
E10157
Atrioventricular Block
Description

AV Block

Data type

string

Alias
UMLS CUI
C0004245
SNOMED CT 2010_0731
233917008
MedDRA 13.1
10003671
ICD-10-CM Version 2010
I44.30
ICD-9-CM Version 2011
426.10
Decreased heart rate
Description

Bradycardia

Data type

string

Alias
UMLS CUI
C0428977
SNOMED CT 2010_0731
48867003
MedDRA 13.1
10006093
ICD-10-CM Version 2010
R00.1
QTC interval
Description

QTC interval

Data type

string

Alias
UMLS CUI
C0489625
LOINC Version 232
MTHU024527
Finding of ECG QT interval (finding)
Description

QT interval - finding

Data type

string

Alias
UMLS CUI
C1287082
SNOMED CT 2010_0731
365417009
U wave feature (observable entity)
Description

U Waves

Data type

string

Alias
UMLS CUI
C0232333
SNOMED CT 2010_0731
39438000
MedDRA 13.1
10045281
Syndrome
Description

Syndrome

Data type

string

Alias
UMLS CUI
C0039082
SNOMED CT 2010_0731
64572001
congenital
Description

congenital

Data type

string

Alias
UMLS CUI
C0009678
Ventricular arrhythmia
Description

Ventricular arrhythmia

Data type

string

Alias
UMLS CUI
C0085612
SNOMED CT 2010_0731
44103008
MedDRA 13.1
10047281
ICD-10-CM Version 2010
I49.01
CTCAE Version 4.03
E10230
Ventricular tachycardia, polymorphic with Q-T prolongation
Description

Torsades de Pointes

Data type

string

Alias
UMLS CUI
C0040479
SNOMED CT 2010_0731
31722008
MedDRA 13.1
10044066
Simultaneous (qualifier value)
Description

Simultaneous

Data type

string

Alias
UMLS CUI
C0521115
SNOMED CT 2010_0731
79970003
1-(1,1-Dimethylethyl)-4,4-diphenylpiperidine
Description

Budipine

Data type

string

Alias
UMLS CUI
C0054202
Antiarrhythmic drug
Description

Antiarrhythmic drug

Data type

string

Alias
UMLS CUI
C0003195
SNOMED CT 2010_0731
67507000
Antipsychotic agent (substance)
Description

Antipsychotic Agent

Data type

string

Alias
UMLS CUI
C0040615
SNOMED CT 2010_0731
372482001
LOINC Version 232
MTHU003337
Tricyclic Antidepressive Agents
Description

Tricyclic antidepressant

Data type

string

Alias
UMLS CUI
C0003290
SNOMED CT 2010_0731
373253007
LOINC Version 232
MTHU001920
Tetracyclic antidepressant (substance)
Description

Tetracyclic antidepressant

Data type

string

Alias
UMLS CUI
C0360108
SNOMED CT 2010_0731
372576002
antihistaminics
Description

Antihistamines

Data type

string

Alias
UMLS CUI
C0019590
SNOMED CT 2010_0731
372806008
LOINC Version 232
MTHU003328
Macrolide (substance)
Description

Macrolides

Data type

string

Alias
UMLS CUI
C0282563
SNOMED CT 2010_0731
428787002
DNA Gyrase Inhibitors [MoA]
Description

DNA Gyrase Inhibitors

Data type

string

Alias
UMLS CUI
C2936780
Azole antifungal (substance)
Description

Azole antifungal

Data type

string

Alias
UMLS CUI
C0360363
SNOMED CT 2010_0731
373236000
Glaucoma
Description

Glaucoma

Data type

string

Alias
UMLS CUI
C0017601
SNOMED CT 2010_0731
23986001
MedDRA 13.1
10018304
LOINC Version 232
MTHU020819
ICD-10-CM Version 2010
H40-H42
ICD-9-CM Version 2011
365
CTCAE Version 4.03
E10392
Angle Closure Glaucoma
Description

obstructive glaucoma

Data type

string

Alias
UMLS CUI
C0017605
SNOMED CT 2010_0731
392291006
MedDRA 13.1
10002500
Excitable
Description

Excitable

Data type

string

Alias
UMLS CUI
C0857393
MedDRA 13.1
10015623
Confusional state (disorder)
Description

Confusion

Data type

string

Alias
UMLS CUI
C0009676
SNOMED CT 2010_0731
286933003
MedDRA 13.1
10010305
LOINC Version 232
MTHU019384
ICD-10-CM Version 2010
R41.0
CTCAE Version 4.03
E12889
Delirium (disorder)
Description

Delirium

Data type

string

Alias
UMLS CUI
C0011206
SNOMED CT 2010_0731
2776000
MedDRA 13.1
10012218
LOINC Version 232
MTHU031955
ICD-10-CM Version 2010
R41.0
CTCAE Version 4.03
E12898
Psychosis (Psychotic disorder)
Description

Psychotic Disorders

Data type

string

Alias
UMLS CUI
C0033975
SNOMED CT 2010_0731
69322001
MedDRA 13.1
10061920
ICD-9-CM Version 2011
290-299.99
CTCAE Version 4.03
E12954
exogen
Description

exogen

Data type

string

Alias
UMLS CUI
C1752469
Immunologic Memory
Description

Anamnesis

Data type

string

Alias
UMLS CUI
C0021055
SNOMED CT 2010_0731
940000
Hyperplasia of prostate
Description

Prostatic Hyperplasia

Data type

string

Alias
UMLS CUI
C2937421
SNOMED CT 2010_0731
433234005
MedDRA 13.1
10020728
ICD-10-CM Version 2010
N40
ICD-9-CM Version 2011
600
Diuretic (substance)
Description

Diuretic

Data type

string

Alias
UMLS CUI
C0012798
SNOMED CT 2010_0731
372695000
LOINC Version 232
MTHU003217
Triamterene (substance)
Description

Triamterene

Data type

string

Alias
UMLS CUI
C0040869
SNOMED CT 2010_0731
387053007
LOINC Version 232
MTHU001919
Hydrochlorothiazide (substance)
Description

Hydrochlorothiazide

Data type

string

Alias
UMLS CUI
C0020261
SNOMED CT 2010_0731
387525002
LOINC Version 232
MTHU016732
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Requirement
Description

Requirement

Data type

string

Alias
UMLS CUI
C1514873
Clinical Trials
Description

Study

Data type

string

Alias
UMLS CUI
C0008976
SNOMED CT 2010_0731
110465008

Similar models

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
C4050412 (UMLS CUI)
HCC
Item
Hepatocellular Carcinoma
string
C2239176 (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
C0086582 (UMLS CUI)
Female
Item
Female Gender
string
C0086287 (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
C1281905 (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
C0019590 (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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