ID

43272

Descrição

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

Palavras-chave

  1. 12/03/2012 12/03/2012 -
  2. 13/04/2014 13/04/2014 - Julian Varghese
  3. 11/06/2015 11/06/2015 - Martin Dugas
  4. 20/09/2021 20/09/2021 -
Transferido a

20 de setembro de 2021

DOI

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Licença

Creative Commons BY 4.0

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Hepatitis C Eligibility NCT00299923

Eligibility Hepatitis C, Chronic Relapse NCT00299923

Einschlusskriterien
Descrição

Einschlusskriterien

Alias
UMLS CUI-1
C1512693
Alter 18 Jahre und älter
Descrição

Alter 18 Jahre und älter

Tipo de dados

boolean

Alias
UMLS CUI-1
C0001779
Relapsers to combination therapy with negative HCV-RNA test result at treatment's end and positive HCV-RNA test result during follow-up
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

Chronic HCV infection genotype 1 or 3
Descrição

HCV infection genotype 1 or 3

Tipo de dados

boolean

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

quantitative HCV-RNA PCR test

Tipo de dados

boolean

Compensated liver disease (Child-Pugh A)
Descrição

liver disease (Child-Pugh A)

Tipo de dados

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
Descrição

Exclusion of HCC in patients with cirrhosis

Tipo de dados

boolean

Negative urine or blood pregnancy test
Descrição

Negative pregnancy test

Tipo de dados

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
Descrição

fertile males and females use two forms of contraception

Tipo de dados

boolean

Ausschlusskriterien
Descrição

Ausschlusskriterien

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

Hypersensitiveness to ingredient of the drugs

Tipo de dados

boolean

Ongoing pregnancy or breast feeding
Descrição

pregnancy or breast feeding

Tipo de dados

boolean

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

Male partners of women who are pregnant or without contraception

Tipo de dados

boolean

Signs or symptoms of hepatocellular carcinoma
Descrição

hepatocellular carcinoma

Tipo de dados

boolean

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

HCV infection genotype 2, 4, 5 or 6

Tipo de dados

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.
Descrição

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.

Tipo de dados

boolean

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

investigational drug < 6 weeks prior to the study drug

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

chronic liver disease other than HCV

Tipo de dados

boolean

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

decompensated liver disease or Child-Pugh score > 6

Tipo de dados

boolean

Hb <12 g/dL bei Frauen oder <13 g/dL bei Männern beim Screening
Descrição

Hb <12 g/dL bei Frauen oder <13 g/dL bei Männern beim Screening

Tipo de dados

boolean

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

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

Tipo de dados

boolean

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

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

Tipo de dados

boolean

Serum creatinin concentration >1.5 mg/dl
Descrição

Serum creatinin concentration >1.5 mg/dl

Tipo de dados

boolean

History of severe psychiatric disease, especially depression.
Descrição

severe psychiatric disease

Tipo de dados

boolean

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

seizure disorder not stabilizable by medication

Tipo de dados

boolean

History of immunologically mediated disease
Descrição

immunologically mediated disease

Tipo de dados

boolean

Chronic pulmonary disease associated with functional limitation
Descrição

Chronic pulmonary disease

Tipo de dados

boolean

History of severe cardiac disease
Descrição

severe cardiac disease

Tipo de dados

boolean

History of major organ transplantation except corneatransplantation
Descrição

major organ transplantation except corneatransplantation

Tipo de dados

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
Descrição

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

Tipo de dados

boolean

Thyroid dysfunction not adequately controlled
Descrição

Thyroid dysfunction not adequately controlled

Tipo de dados

boolean

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

severe retinopathy or ophthalmological disorder due to diabetes mellitus or hypertension

Tipo de dados

boolean

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

active drug abuse

Tipo de dados

boolean

Take of Memantine during study period
Descrição

Take of Memantine

Tipo de dados

boolean

Cardiomyopathy and myocarditis
Descrição

Cardiomyopathy and myocarditis

Tipo de dados

boolean

AV-Block II and III
Descrição

AV-Block II and III

Tipo de dados

boolean

Pre-existing bradycardia < 55 counts/min
Descrição

bradycardia < 55 counts/min

Tipo de dados

boolean

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

QT-interval or U-waves or QT-syndrome

Tipo de dados

boolean

History of severe ventricular arrhythmia incl. Torsade de pointes
Descrição

severe ventricular arrhythmia

Tipo de dados

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)
Descrição

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

Tipo de dados

boolean

Patients with obstructive glaucoma
Descrição

obstructive glaucoma

Tipo de dados

boolean

Patients with excitableness and confusion
Descrição

excitableness and confusion

Tipo de dados

boolean

Patients with delirium and exogenic psychosis in the anamnesis
Descrição

delirium and exogenic psychosis in the anamnesis

Tipo de dados

boolean

Prostataadenome
Descrição

Prostataadenome

Tipo de dados

boolean

Diuretic medication of the type combination Triamterene/ Hydrochlorothiazide
Descrição

medication of type combination Triamterene/ Hydrochlorothiazide

Tipo de dados

boolean

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

lack of informed consent or of abidance by the study requirements

Tipo de dados

boolean

Medizinische Konzepte
Descrição

Medizinische Konzepte

Polyethylene Glycols
Descrição

PEG

Tipo de dados

string

Alias
UMLS CUI
C0032483
SNOMED CT 2010_0731
8030004
Interferon-alpha, IFN-alpha
Descrição

IFN Alpha

Tipo de dados

string

Alias
UMLS CUI
C1610033
Ribavirin
Descrição

Ribavirin

Tipo de dados

string

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

HCV RNA

Tipo de dados

string

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

Test

Tipo de dados

string

Alias
UMLS CUI
C0392366
SNOMED CT 2010_0731
C47891
negativ
Descrição

Negative

Tipo de dados

string

Alias
UMLS CUI
CL415098
Therapie
Descrição

Therapy

Tipo de dados

string

Alias
UMLS CUI
C0087111
positiv
Descrição

positive

Tipo de dados

string

Alias
UMLS CUI
CL415097
Follow-up
Descrição

Follow-up

Tipo de dados

string

Alias
UMLS CUI
C1522577
Period (temporal concept)
Descrição

Period

Tipo de dados

string

Alias
UMLS CUI
C1948053
Registrierung
Descrição

Enrollment

Tipo de dados

string

Alias
UMLS CUI
C2348568
Hepatitis-C-Virus
Descrição

HCV

Tipo de dados

string

Alias
UMLS CUI
C0220847
SNOMED CT 2010_0731
62944002
MedDRA 13.1
10019752
chronisch
Descrição

chronic

Tipo de dados

string

Alias
UMLS CUI
C0205191
SNOMED CT 2010_0731
90734009
Infektion
Descrição

Infection

Tipo de dados

string

Alias
UMLS CUI
C0009450
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Genotyp
Descrição

Genotype

Tipo de dados

string

Alias
UMLS CUI
C0017431
Serum
Descrição

Serum

Tipo de dados

string

Alias
UMLS CUI
C0229671
SNOMED CT 2010_0731
67922002
LOINC Version 232
MTHU001009
internationale Einheit, IE
Descrição

IU

Tipo de dados

string

Alias
UMLS CUI
C0439453
SNOMED CT 2010_0731
258997004
HL7 V3 02-34
[IU]
Polymerase-Kettenreaktion
Descrição

PCR

Tipo de dados

string

Alias
UMLS CUI
C0032520
SNOMED CT 2010_0731
258066000
MedDRA 13.1
10050967
HL7 V3 02-34
132
quantitativ
Descrição

Quantitative

Tipo de dados

string

Alias
UMLS CUI
C0392762
SNOMED CT 2010_0731
30766002
Lebererkrankung
Descrição

Liver disorder

Tipo de dados

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
Descrição

Child-Pugh Classification

Tipo de dados

string

Alias
UMLS CUI
C4050412
Leberzellkarzinom
Descrição

HCC

Tipo de dados

string

Alias
UMLS CUI
C2239176
MedDRA 13.1
10049010
Leberzirrhose
Descrição

Hepatic Cirrhosis

Tipo de dados

string

Alias
UMLS CUI
C0023890
SNOMED CT 2010_0731
19943007
MedDRA 13.1
10019641
ICD-10-CM Version 2010
K74.60
Alpha-Fetoprotein
Descrição

AFP measurement

Tipo de dados

string

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

Assay

Tipo de dados

string

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

Urine pregnancy test negative

Tipo de dados

string

Alias
UMLS CUI
C0430057
SNOMED CT 2010_0731
167254001
MedDRA 13.1
10036577
negativer Schwangerschaftstest
Descrição

Negative Pregnancy Test

Tipo de dados

string

Alias
UMLS CUI
C0427780
SNOMED CT 2010_0731
250425007
MedDRA 13.1
10036574
Blut
Descrição

blood

Tipo de dados

string

Alias
UMLS CUI
C0005768
fertil
Descrição

Fertile

Tipo de dados

string

Alias
UMLS CUI
CL426012
maskulin, männlich
Descrição

Male

Tipo de dados

string

Alias
UMLS CUI
C0086582
feminin, weiblich
Descrição

Female

Tipo de dados

string

Alias
UMLS CUI
C0086287
Kontrazeption
Descrição

Contraception

Tipo de dados

string

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

Hypersensitivity

Tipo de dados

string

Alias
UMLS CUI
C0020517
SNOMED CT 2010_0731
418634005
ICD-10-CM Version 2010
T78.40
Interferon, IFN
Descrição

Interferons

Tipo de dados

string

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

peginterferon alfa-2a

Tipo de dados

string

Alias
UMLS CUI
C0391001
SNOMED CT 2010_0731
421559001
Amantadin
Descrição

Amantadine

Tipo de dados

string

Alias
UMLS CUI
C0002403
SNOMED CT 2010_0731
372763006
LOINC Version 232
MTHU006774
Medikation
Descrição

Pharmaceutical Preparations

Tipo de dados

string

Alias
UMLS CUI
C0013227
Schwangerschaft
Descrição

Pregnancy

Tipo de dados

string

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

pregnant

Tipo de dados

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Stillzeit
Descrição

Lactation

Tipo de dados

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
signs
Descrição

signs

Tipo de dados

string

Alias
UMLS CUI
C0220912
Symptom
Descrição

Symptoms

Tipo de dados

string

Alias
UMLS CUI
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
Systemische Therapie
Descrição

Systemic Therapy

Tipo de dados

string

Alias
UMLS CUI
C1515119
Antiviral treatment
Descrição

Antiviral treatment

Tipo de dados

string

Alias
UMLS CUI
C2363964
MedDRA 13.1
10068724
Immunotherapy, antineoplastic
Descrição

antineoplastic Immunotherapy

Tipo de dados

string

Alias
UMLS CUI
C0864561
Immunomodulatory or immunosuppressive therapy
Descrição

Immunomodulatory or immunosuppressive therapy

Tipo de dados

string

Alias
UMLS CUI
C1963758
SNOMED CT 2010_0731
86553008
MedDRA 13.1
10067473
Acyclovir
Descrição

Acyclovir

Tipo de dados

string

Alias
UMLS CUI
C0001367
SNOMED CT 2010_0731
372729009
LOINC Version 232
MTHU006764
Valacyclovir
Descrição

Valaciclovir

Tipo de dados

string

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

Herpes dermatitis

Tipo de dados

string

Alias
UMLS CUI
C1262170
MedDRA 13.1
10062639
Investigational New Drug
Descrição

Investigational Drug

Tipo de dados

string

Alias
UMLS CUI
C0013230
Hepatitis-A-Virus, HAV
Descrição

HAV

Tipo de dados

string

Alias
UMLS CUI
C0376325
SNOMED CT 2010_0731
32452004
Immunglobulin, IgM
Descrição

IgM

Tipo de dados

string

Alias
UMLS CUI
C0020861
SNOMED CT 2010_0731
74889000
LOINC Version 232
MTHU004563
Hepatitis-B-Oberflächenantigen
Descrição

HBsAg

Tipo de dados

string

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

HBc IgM

Tipo de dados

string

Alias
UMLS CUI
C1277836
SNOMED CT 2010_0731
315132007
HIV-Virus
Descrição

HIV

Tipo de dados

string

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

Decompensated Liver Disease

Tipo de dados

string

Alias
UMLS CUI
C0745744
MedDRA 13.1
10050060
Mann
Descrição

man

Tipo de dados

string

Alias
UMLS CUI
C0025266
SNOMED CT 2010_0731
339947000
Frau
Descrição

Woman

Tipo de dados

string

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

disorder risk

Tipo de dados

string

Alias
UMLS CUI
C1281905
Anämie
Descrição

Anemia

Tipo de dados

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
Descrição

Baseline

Tipo de dados

string

Alias
UMLS CUI
C1442488
Neutrophil count (procedure)
Descrição

Neutrophil count

Tipo de dados

string

Alias
UMLS CUI
C0200633
SNOMED CT 2010_0731
30630007
MedDRA 13.1
10029363
Thrombozyten
Descrição

Platelet count

Tipo de dados

string

Alias
UMLS CUI
C1287267
SNOMED CT 2010_0731
365632008
LOINC Version 232
777-3
Kreatinin im Serum
Descrição

Serum Creatinine

Tipo de dados

string

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

Concentration

Tipo de dados

string

Alias
UMLS CUI
C1446561
Psychiatric disorder
Descrição

Mental disorders

Tipo de dados

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
Descrição

Depressive disorder

Tipo de dados

string

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

Epilepsy

Tipo de dados

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
Stabilisierung
Descrição

Stabilization

Tipo de dados

string

Alias
UMLS CUI
C1293130
SNOMED CT 2010_0731
115979005
Immunotherapy
Descrição

Immunotherapy

Tipo de dados

string

Alias
UMLS CUI
C0021083
SNOMED CT 2010_0731
146638005
Lungenerkrankung
Descrição

Pulmonary disease

Tipo de dados

string

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

Limitation

Tipo de dados

string

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

Functional Status

Tipo de dados

string

Alias
UMLS CUI
C0598463
LOINC Version 232
MTHU027728
Herzkrankheit
Descrição

Cardiac disease

Tipo de dados

string

Alias
UMLS CUI
C0018799
SNOMED CT 2010_0731
56265001
MedDRA 13.1
10061024
Organtransplantation
Descrição

Organ Transplantation

Tipo de dados

string

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

Major

Tipo de dados

string

Alias
UMLS CUI
C0205164
SNOMED CT 2010_0731
255603008
Keratoplastik, Hornhauttransplantation
Descrição

Keratoplasty

Tipo de dados

string

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

Disease

Tipo de dados

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
Krebs
Descrição

Cancer

Tipo de dados

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
Descrição

Thyroid dysfunction

Tipo de dados

string

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

Retinopathy

Tipo de dados

string

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

Disorder of eye

Tipo de dados

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
Descrição

Diabetes mellitus

Tipo de dados

string

Alias
UMLS CUI
C0011849
SNOMED CT 2010_0731
191044006
Hypertonie
Descrição

Hypertension

Tipo de dados

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
Descrição

Drug abuse

Tipo de dados

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
aktiv
Descrição

Active

Tipo de dados

string

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

Prescriptions

Tipo de dados

string

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

Opioid Rotation

Tipo de dados

string

Alias
UMLS CUI
C1518592
Stability
Descrição

Stable status

Tipo de dados

string

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

Memantine

Tipo de dados

string

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

Take

Tipo de dados

string

Alias
UMLS CUI
C1515187
SNOMED CT 2010_0731
419652001
Kardiomyopathie
Descrição

Cardiomyopathy

Tipo de dados

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
Myokarditis
Descrição

Myocarditis

Tipo de dados

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
AV-Block
Descrição

AV Block

Tipo de dados

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
Bradykardie
Descrição

Bradycardia

Tipo de dados

string

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

QTC interval

Tipo de dados

string

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

QT interval - finding

Tipo de dados

string

Alias
UMLS CUI
C1287082
SNOMED CT 2010_0731
365417009
U-Welle
Descrição

U Waves

Tipo de dados

string

Alias
UMLS CUI
C0232333
SNOMED CT 2010_0731
39438000
MedDRA 13.1
10045281
Syndrom
Descrição

Syndrome

Tipo de dados

string

Alias
UMLS CUI
C0039082
SNOMED CT 2010_0731
64572001
kongenital
Descrição

congenital

Tipo de dados

string

Alias
UMLS CUI
C0009678
Ventrikuläre Arrhythmie
Descrição

Ventricular arrhythmia

Tipo de dados

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
Descrição

Torsades de Pointes

Tipo de dados

string

Alias
UMLS CUI
C0040479
SNOMED CT 2010_0731
31722008
MedDRA 13.1
10044066
simultan
Descrição

Simultaneous

Tipo de dados

string

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

Budipine

Tipo de dados

string

Alias
UMLS CUI
C0054202
Antiarrhythmic drug
Descrição

Antiarrhythmic drug

Tipo de dados

string

Alias
UMLS CUI
C0003195
SNOMED CT 2010_0731
67507000
Antipsychotika
Descrição

Antipsychotic Agent

Tipo de dados

string

Alias
UMLS CUI
C0040615
SNOMED CT 2010_0731
372482001
LOINC Version 232
MTHU003337
trizyklisches Antidepressivum
Descrição

Tricyclic antidepressant

Tipo de dados

string

Alias
UMLS CUI
C0003290
SNOMED CT 2010_0731
373253007
LOINC Version 232
MTHU001920
tetrazyklisches Antidepressivum
Descrição

Tetracyclic antidepressant

Tipo de dados

string

Alias
UMLS CUI
C0360108
SNOMED CT 2010_0731
372576002
Antihistaminikum
Descrição

Antihistamines

Tipo de dados

string

Alias
UMLS CUI
C0019590
SNOMED CT 2010_0731
372806008
LOINC Version 232
MTHU003328
Makrolid
Descrição

Macrolides

Tipo de dados

string

Alias
UMLS CUI
C0282563
SNOMED CT 2010_0731
428787002
Gyraseinhibitor
Descrição

DNA Gyrase Inhibitors

Tipo de dados

string

Alias
UMLS CUI
C2936780
Azole antifungal (substance)
Descrição

Azole antifungal

Tipo de dados

string

Alias
UMLS CUI
C0360363
SNOMED CT 2010_0731
373236000
Glaukom
Descrição

Glaucoma

Tipo de dados

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
Engwinkelglaukom
Descrição

obstructive glaucoma

Tipo de dados

string

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

Excitable

Tipo de dados

string

Alias
UMLS CUI
C0857393
MedDRA 13.1
10015623
Konfusion
Descrição

Confusion

Tipo de dados

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
Descrição

Delirium

Tipo de dados

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
Psychose
Descrição

Psychotic Disorders

Tipo de dados

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
Descrição

exogen

Tipo de dados

string

Alias
UMLS CUI
C1752469
Anamnese
Descrição

Anamnesis

Tipo de dados

string

Alias
UMLS CUI
C0021055
SNOMED CT 2010_0731
940000
Prostatahyperplasie, Prostata-Adenom
Descrição

Prostatic Hyperplasia

Tipo de dados

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
Diuretikum
Descrição

Diuretic

Tipo de dados

string

Alias
UMLS CUI
C0012798
SNOMED CT 2010_0731
372695000
LOINC Version 232
MTHU003217
Triamteren
Descrição

Triamterene

Tipo de dados

string

Alias
UMLS CUI
C0040869
SNOMED CT 2010_0731
387053007
LOINC Version 232
MTHU001919
Hydrochlorothiazid
Descrição

Hydrochlorothiazide

Tipo de dados

string

Alias
UMLS CUI
C0020261
SNOMED CT 2010_0731
387525002
LOINC Version 232
MTHU016732
Einverständniserklärung
Descrição

Informed Consent

Tipo de dados

string

Alias
UMLS CUI
C0021430
Erfordernis
Descrição

Requirement

Tipo de dados

string

Alias
UMLS CUI
C1514873
Studie
Descrição

Study

Tipo de dados

string

Alias
UMLS CUI
C0008976
SNOMED CT 2010_0731
110465008

Similar models

Eligibility Hepatitis C, Chronic Relapse NCT00299923

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Einschlusskriterien
C1512693 (UMLS CUI-1)
Age
Item
Alter 18 Jahre und älter
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
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
Ausschlusskriterien
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 bei Frauen oder <13 g/dL bei Männern beim 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
Medizinische Konzepte
PEG
Item
Polyethylene Glycols
string
C0032483 (UMLS CUI)
8030004 (SNOMED CT 2010_0731)
IFN Alpha
Item
Interferon-alpha, IFN-alpha
string
C1610033 (UMLS CUI)
Ribavirin
Item
Ribavirin
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
negativ
string
CL415098 (UMLS CUI)
Therapy
Item
Therapie
string
C0087111 (UMLS CUI)
positive
Item
positiv
string
CL415097 (UMLS CUI)
Follow-up
Item
Follow-up
string
C1522577 (UMLS CUI)
Period
Item
Period (temporal concept)
string
C1948053 (UMLS CUI)
Enrollment
Item
Registrierung
string
C2348568 (UMLS CUI)
HCV
Item
Hepatitis-C-Virus
string
C0220847 (UMLS CUI)
62944002 (SNOMED CT 2010_0731)
10019752 (MedDRA 13.1)
chronic
Item
chronisch
string
C0205191 (UMLS CUI)
90734009 (SNOMED CT 2010_0731)
Infection
Item
Infektion
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
Genotype
Item
Genotyp
string
C0017431 (UMLS CUI)
Serum
Item
Serum
string
C0229671 (UMLS CUI)
67922002 (SNOMED CT 2010_0731)
MTHU001009 (LOINC Version 232)
IU
Item
internationale Einheit, IE
string
C0439453 (UMLS CUI)
258997004 (SNOMED CT 2010_0731)
[IU] (HL7 V3 02-34)
PCR
Item
Polymerase-Kettenreaktion
string
C0032520 (UMLS CUI)
258066000 (SNOMED CT 2010_0731)
10050967 (MedDRA 13.1)
132 (HL7 V3 02-34)
Quantitative
Item
quantitativ
string
C0392762 (UMLS CUI)
30766002 (SNOMED CT 2010_0731)
Liver disorder
Item
Lebererkrankung
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
Leberzellkarzinom
string
C2239176 (UMLS CUI)
10049010 (MedDRA 13.1)
Hepatic Cirrhosis
Item
Leberzirrhose
string
C0023890 (UMLS CUI)
19943007 (SNOMED CT 2010_0731)
10019641 (MedDRA 13.1)
K74.60 (ICD-10-CM Version 2010)
AFP measurement
Item
Alpha-Fetoprotein
string
C0201539 (UMLS CUI)
80152001 (SNOMED CT 2010_0731)
10001455 (MedDRA 13.1)
Assay
Item
Assay
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
negativer Schwangerschaftstest
string
C0427780 (UMLS CUI)
250425007 (SNOMED CT 2010_0731)
10036574 (MedDRA 13.1)
blood
Item
Blut
string
C0005768 (UMLS CUI)
Fertile
Item
fertil
string
CL426012 (UMLS CUI)
Male
Item
maskulin, männlich
string
C0086582 (UMLS CUI)
Female
Item
feminin, weiblich
string
C0086287 (UMLS CUI)
Contraception
Item
Kontrazeption
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, IFN
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
Amantadin
string
C0002403 (UMLS CUI)
372763006 (SNOMED CT 2010_0731)
MTHU006774 (LOINC Version 232)
Pharmaceutical Preparations
Item
Medikation
string
C0013227 (UMLS CUI)
Pregnancy
Item
Schwangerschaft
string
C0549206 (UMLS CUI)
289908002 (SNOMED CT 2010_0731)
10036556 (MedDRA 13.1)
MTHU035048 (LOINC Version 232)
pregnant
Item
schwanger
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Stillzeit
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
signs
Item
signs
string
C0220912 (UMLS CUI)
Symptoms
Item
Symptom
string
C1457887 (UMLS CUI)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
Systemic Therapy
Item
Systemische Therapie
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
string
C0001367 (UMLS CUI)
372729009 (SNOMED CT 2010_0731)
MTHU006764 (LOINC Version 232)
Valaciclovir
Item
Valacyclovir
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, HAV
string
C0376325 (UMLS CUI)
32452004 (SNOMED CT 2010_0731)
IgM
Item
Immunglobulin, IgM
string
C0020861 (UMLS CUI)
74889000 (SNOMED CT 2010_0731)
MTHU004563 (LOINC Version 232)
HBsAg
Item
Hepatitis-B-Oberflächenantigen
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
HIV-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
Mann
string
C0025266 (UMLS CUI)
339947000 (SNOMED CT 2010_0731)
Woman
Item
Frau
string
C0043210 (UMLS CUI)
224526002 (SNOMED CT 2010_0731)
disorder risk
Item
disease risk
string
C1281905 (UMLS CUI)
Anemia
Item
Anämie
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
Thrombozyten
string
C1287267 (UMLS CUI)
365632008 (SNOMED CT 2010_0731)
777-3 (LOINC Version 232)
Serum Creatinine
Item
Kreatinin im Serum
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
Stabilisierung
string
C1293130 (UMLS CUI)
115979005 (SNOMED CT 2010_0731)
Immunotherapy
Item
Immunotherapy
string
C0021083 (UMLS CUI)
146638005 (SNOMED CT 2010_0731)
Pulmonary disease
Item
Lungenerkrankung
string
C0024115 (UMLS CUI)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)
Limitation
Item
Limitation
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
Herzkrankheit
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
Organ Transplantation
Item
Organtransplantation
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
Keratoplastik, Hornhauttransplantation
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
Krebs
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
Hypertonie
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
aktiv
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
Kardiomyopathie
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
Myokarditis
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
AV-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
Bradykardie
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-Welle
string
C0232333 (UMLS CUI)
39438000 (SNOMED CT 2010_0731)
10045281 (MedDRA 13.1)
Syndrome
Item
Syndrom
string
C0039082 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
congenital
Item
kongenital
string
C0009678 (UMLS CUI)
Ventricular arrhythmia
Item
Ventrikuläre Arrhythmie
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
simultan
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
Antipsychotika
string
C0040615 (UMLS CUI)
372482001 (SNOMED CT 2010_0731)
MTHU003337 (LOINC Version 232)
Tricyclic antidepressant
Item
trizyklisches Antidepressivum
string
C0003290 (UMLS CUI)
373253007 (SNOMED CT 2010_0731)
MTHU001920 (LOINC Version 232)
Tetracyclic antidepressant
Item
tetrazyklisches Antidepressivum
string
C0360108 (UMLS CUI)
372576002 (SNOMED CT 2010_0731)
Antihistamines
Item
Antihistaminikum
string
C0019590 (UMLS CUI)
372806008 (SNOMED CT 2010_0731)
MTHU003328 (LOINC Version 232)
Macrolides
Item
Makrolid
string
C0282563 (UMLS CUI)
428787002 (SNOMED CT 2010_0731)
DNA Gyrase Inhibitors
Item
Gyraseinhibitor
string
C2936780 (UMLS CUI)
Azole antifungal
Item
Azole antifungal (substance)
string
C0360363 (UMLS CUI)
373236000 (SNOMED CT 2010_0731)
Glaucoma
Item
Glaukom
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
Engwinkelglaukom
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
Konfusion
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
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
Psychose
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
Anamnese
string
C0021055 (UMLS CUI)
940000 (SNOMED CT 2010_0731)
Prostatic Hyperplasia
Item
Prostatahyperplasie, Prostata-Adenom
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
Diuretikum
string
C0012798 (UMLS CUI)
372695000 (SNOMED CT 2010_0731)
MTHU003217 (LOINC Version 232)
Triamterene
Item
Triamteren
string
C0040869 (UMLS CUI)
387053007 (SNOMED CT 2010_0731)
MTHU001919 (LOINC Version 232)
Hydrochlorothiazide
Item
Hydrochlorothiazid
string
C0020261 (UMLS CUI)
387525002 (SNOMED CT 2010_0731)
MTHU016732 (LOINC Version 232)
Informed Consent
Item
Einverständniserklärung
string
C0021430 (UMLS CUI)
Requirement
Item
Erfordernis
string
C1514873 (UMLS CUI)
Study
Item
Studie
string
C0008976 (UMLS CUI)
110465008 (SNOMED CT 2010_0731)

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