ID

4863

Beskrivning

ODM derived from http://clinicaltrials.gov/show/NCT00185250

Länk

http://clinicaltrials.gov/show/NCT00185250

Nyckelord

Versioner (2)
  1. 2011-12-08 2011-12-08 -
  2. 2014-04-13 2014-04-13 - Julian Varghese
Uppladdad den

13 april 2014

DOI

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Creative Commons BY 4.0
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Eligibility NCT00185250 Cardiomyopathies Heart Dis

Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Beskrivning

Inclusion Criteria

18 Years to 75 Years
Beskrivning

Age

Datatyp

boolean

Unexplained heart with evidence of Adeno-, Entero- and/or Parvoviruses which must be identified directly in the heart tissue
Beskrivning

Adeno-, Entero- and/or Parvoviruses directly in the heart tissue

Datatyp

boolean

Being in a chronic (at least 6 month after the onset of clinical symptoms) and stable phase of the disease
Beskrivning

chronic and stable disease

Datatyp

boolean

Impaired cardiac function
Beskrivning

Impaired cardiac function

Datatyp

boolean

Exclusion Criteria
Beskrivning

Exclusion Criteria

Severe (decompensated) or acute heart failure
Beskrivning

heart failure

Datatyp

boolean

Any other disease which could better explain the patient's clinical symptoms
Beskrivning

other disease

Datatyp

boolean

Any other severe and/or malignant disease
Beskrivning

Any other severe and/or malignant disease

Datatyp

boolean

Suffering from convulsions, depression or suicidal ideas judged by a physician
Beskrivning

convulsions, depression

Datatyp

boolean

Serious viral or bacterial infections during the last weeks
Beskrivning

serious infections

Datatyp

boolean

Pregnancy or lactation
Beskrivning

Pregnancy or lactation

Datatyp

boolean

Medical concepts
Beskrivning

Medical concepts

Age
Beskrivning

Age

Datatyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Beskrivning

Diagnosis

Datatyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
LOINC Version 232
MTHU008876
Cardiac disorder
Beskrivning

Heart Diseases

Datatyp

string

Alias
UMLS CUI
C0018799
SNOMED CT 2010_0731
56265001
MedDRA 13.1
10061024
ICD-10-CM Version 2010
I51.9
ICD-9-CM Version 2011
429.9
Heart failure
Beskrivning

Heart failure

Datatyp

string

Alias
UMLS CUI
C0018801
SNOMED CT 2010_0731
155374007
MedDRA 13.1
10019279
ICD-9-CM Version 2011
428
CTCAE Version 4.03
E10124
Cardiomyopathy
Beskrivning

Cardiomyopathy

Datatyp

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
Viral cardiomyopathy
Beskrivning

Viral cardiomyopathy

Datatyp

string

Alias
UMLS CUI
C1411027
MedDRA 13.1
10068767
ICD-10-CM Version 2010
B33.24
Adenovirus
Beskrivning

Adenoviruses

Datatyp

string

Alias
UMLS CUI
C0001483
SNOMED CT 2010_0731
424470006
LOINC Version 232
MTHU032043
Enterovirus
Beskrivning

Enteroviruses

Datatyp

string

Alias
UMLS CUI
C0014383
SNOMED CT 2010_0731
243633006
Parvovirus
Beskrivning

Parvoviruses

Datatyp

string

Alias
UMLS CUI
C0086776
SNOMED CT 2010_0731
11970002
Chronic disease
Beskrivning

Chronic disease

Datatyp

string

Alias
UMLS CUI
C0008679
SNOMED CT 2010_0731
27624003
Cardiac rate
Beskrivning

Heart rate

Datatyp

text

Alias
UMLS CUI
C0018810
SNOMED CT 2010_0731
364075005
MedDRA 13.1
10019299
LOINC Version 232
MTHU003114
Cardiac ejection fraction
Beskrivning

EF

Datatyp

string

Alias
UMLS CUI
C0232174
SNOMED CT 2010_0731
70822001
Cardiac Arrhythmia
Beskrivning

Cardiac Arrhythmia

Datatyp

string

Alias
UMLS CUI
C0003811
SNOMED CT 2010_0731
44808001
MedDRA 13.1
10003119
ICD-9-CM Version 2011
427.9
Malignant Neoplasms
Beskrivning

Cancer

Datatyp

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
disorder
Beskrivning

Disease

Datatyp

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
Convulsion
Beskrivning

Seizures

Datatyp

string

Alias
UMLS CUI
C0036572
SNOMED CT 2010_0731
91175000
MedDRA 13.1
10039910
ICD-9-CM Version 2011
780.39
Depression
Beskrivning

Depressive disorder

Datatyp

string

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

Infection

Datatyp

string

Alias
UMLS CUI
C0009450
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
Severe (Qualitative Concept)
Beskrivning

Severe

Datatyp

string

Alias
UMLS CUI
C0205082
SNOMED CT 2010_0731
24484000
pregnant
Beskrivning

pregnant

Datatyp

string

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

Lactation

Datatyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inclusion Criteria
Age
Item
18 Years to 75 Years
boolean
Adeno-, Entero- and/or Parvoviruses directly in the heart tissue
Item
Unexplained heart with evidence of Adeno-, Entero- and/or Parvoviruses which must be identified directly in the heart tissue
boolean
chronic and stable disease
Item
Being in a chronic (at least 6 month after the onset of clinical symptoms) and stable phase of the disease
boolean
Impaired cardiac function
Item
Impaired cardiac function
boolean
Item Group
Exclusion Criteria
heart failure
Item
Severe (decompensated) or acute heart failure
boolean
other disease
Item
Any other disease which could better explain the patient's clinical symptoms
boolean
Any other severe and/or malignant disease
Item
Any other severe and/or malignant disease
boolean
convulsions, depression
Item
Suffering from convulsions, depression or suicidal ideas judged by a physician
boolean
serious infections
Item
Serious viral or bacterial infections during the last weeks
boolean
Pregnancy or lactation
Item
Pregnancy or lactation
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
MTHU008876 (LOINC Version 232)
Heart Diseases
Item
Cardiac disorder
string
C0018799 (UMLS CUI)
56265001 (SNOMED CT 2010_0731)
10061024 (MedDRA 13.1)
I51.9 (ICD-10-CM Version 2010)
429.9 (ICD-9-CM Version 2011)
Heart failure
Item
Heart failure
string
C0018801 (UMLS CUI)
155374007 (SNOMED CT 2010_0731)
10019279 (MedDRA 13.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE Version 4.03)
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)
Viral cardiomyopathy
Item
Viral cardiomyopathy
string
C1411027 (UMLS CUI)
10068767 (MedDRA 13.1)
B33.24 (ICD-10-CM Version 2010)
Adenoviruses
Item
Adenovirus
string
C0001483 (UMLS CUI)
424470006 (SNOMED CT 2010_0731)
MTHU032043 (LOINC Version 232)
Enteroviruses
Item
Enterovirus
string
C0014383 (UMLS CUI)
243633006 (SNOMED CT 2010_0731)
Parvoviruses
Item
Parvovirus
string
C0086776 (UMLS CUI)
11970002 (SNOMED CT 2010_0731)
Chronic disease
Item
Chronic disease
string
C0008679 (UMLS CUI)
27624003 (SNOMED CT 2010_0731)
Heart rate
Item
Cardiac rate
text
C0018810 (UMLS CUI)
364075005 (SNOMED CT 2010_0731)
10019299 (MedDRA 13.1)
MTHU003114 (LOINC Version 232)
EF
Item
Cardiac ejection fraction
string
C0232174 (UMLS CUI)
70822001 (SNOMED CT 2010_0731)
Cardiac Arrhythmia
Item
Cardiac Arrhythmia
string
C0003811 (UMLS CUI)
44808001 (SNOMED CT 2010_0731)
10003119 (MedDRA 13.1)
427.9 (ICD-9-CM Version 2011)
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)
Disease
Item
disorder
string
C0012634 (UMLS CUI)
64572001 (SNOMED CT 2010_0731)
Seizures
Item
Convulsion
string
C0036572 (UMLS CUI)
91175000 (SNOMED CT 2010_0731)
10039910 (MedDRA 13.1)
780.39 (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)
Infection
Item
Infection
string
C0009450 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
Severe
Item
Severe (Qualitative Concept)
string
C0205082 (UMLS CUI)
24484000 (SNOMED CT 2010_0731)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding, Nursing
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Tillbaka till toppen 

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