ID

4863

Descripción

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

Link

http://clinicaltrials.gov/show/NCT00185250

Palabras clave

Versiones (2)
  1. 8/12/11 8/12/11 -
  2. 13/4/14 13/4/14 - Julian Varghese
Subido en

13 de abril de 2014

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility NCT00185250 Cardiomyopathies Heart Dis

Inglés

Eligibility

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Descripción

Inclusion Criteria

18 Years to 75 Years
Descripción

Age

Tipo de datos

boolean

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

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

Tipo de datos

boolean

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

chronic and stable disease

Tipo de datos

boolean

Impaired cardiac function
Descripción

Impaired cardiac function

Tipo de datos

boolean

Exclusion Criteria
Descripción

Exclusion Criteria

Severe (decompensated) or acute heart failure
Descripción

heart failure

Tipo de datos

boolean

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

other disease

Tipo de datos

boolean

Any other severe and/or malignant disease
Descripción

Any other severe and/or malignant disease

Tipo de datos

boolean

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

convulsions, depression

Tipo de datos

boolean

Serious viral or bacterial infections during the last weeks
Descripción

serious infections

Tipo de datos

boolean

Pregnancy or lactation
Descripción

Pregnancy or lactation

Tipo de datos

boolean

Medical concepts
Descripción

Medical concepts

Age
Descripción

Age

Tipo de datos

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Descripción

Diagnosis

Tipo de datos

string

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

Heart Diseases

Tipo de datos

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
Descripción

Heart failure

Tipo de datos

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
Descripción

Cardiomyopathy

Tipo de datos

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
Descripción

Viral cardiomyopathy

Tipo de datos

string

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

Adenoviruses

Tipo de datos

string

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

Enteroviruses

Tipo de datos

string

Alias
UMLS CUI
C0014383
SNOMED CT 2010_0731
243633006
Parvovirus
Descripción

Parvoviruses

Tipo de datos

string

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

Chronic disease

Tipo de datos

string

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

Heart rate

Tipo de datos

text

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

EF

Tipo de datos

string

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

Cardiac Arrhythmia

Tipo de datos

string

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

Cancer

Tipo de datos

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
Descripción

Disease

Tipo de datos

string

Alias
UMLS CUI
C0012634
SNOMED CT 2010_0731
64572001
Convulsion
Descripción

Seizures

Tipo de datos

string

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

Depressive disorder

Tipo de datos

string

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

Infection

Tipo de datos

string

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

Severe

Tipo de datos

string

Alias
UMLS CUI
C0205082
SNOMED CT 2010_0731
24484000
pregnant
Descripción

pregnant

Tipo de datos

string

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

Lactation

Tipo de datos

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
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Similar models

Eligibility

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)
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