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Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 14 Years
Description

age at least 14 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Written informed consent of the patient or patient's legal representatives
Description

Written informed consent of the patient or patient's legal representatives

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
No participation in another AMG driven study within the past 4 weeks or during the whole duration of this study
Description

No participation in another AMG driven study within the past 4 weeks or during the whole duration of this study

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0347984
SNOMED CT 2011_0131
371881003
UMLS CUI 2011AA
C0449238
SNOMED CT 2011_0131
103335007
LOINC Version 232
MTHU001938
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Patients with Tetralogy of Fallot after corrective surgery
Description

Patients with Tetralogy of Fallot after corrective surgery

Data type

boolean

Alias
UMLS CUI 2011AA
C0039685
SNOMED CT 2011_0131
86299006
MedDRA 14.1
10016193
ICD-10-CM Version 2010
Q21.3
ICD-9-CM Version 2011
745.2
UMLS CUI 2011AA
C0719519
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
group A (n=45): Adolescents >= 14 years or adults with Tetralogy of Fallot after corrective surgery and necessary re-intervention (pulmonary valve replacement because of pulmonary insufficiency
Description

group A (n=45): Adolescents >= 14 years or adults with Tetralogy of Fallot after corrective surgery and necessary re-intervention (pulmonary valve replacement because of pulmonary insufficiency

Data type

boolean

Alias
UMLS CUI 2011AA
CL415249
HL7 V3 2006_05
RGRP
UMLS CUI 2011AA
C0205653
SNOMED CT 2011_0131
133937008
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
UMLS CUI 2011AA
C0039685
SNOMED CT 2011_0131
86299006
MedDRA 14.1
10016193
ICD-10-CM Version 2010
Q21.3
ICD-9-CM Version 2011
745.2
UMLS CUI 2011AA
C0719519
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C0205341
SNOMED CT 2011_0131
27582007
UMLS CUI 2011AA
C1948041
SNOMED CT 2011_0131
71388002
MedDRA 14.1
10042613
LOINC Version 232
MTHU006237
ICD-9-CM Version 2011
00-99.99
UMLS CUI 2011AA
C0190129
SNOMED CT 2011_0131
88045004
MedDRA 14.1
10037449
UMLS CUI 2011AA
CL355398
group B (n=35): Adolescents >= 14 years or adults with Tetralogy of Fallot after corrective surgery and good result of repair and good right ventricular function
Description

group B (n=35): Adolescents >= 14 years or adults with Tetralogy of Fallot after corrective surgery and good result of repair and good right ventricular function

Data type

boolean

Alias
UMLS CUI 2011AA
CL415249
UMLS CUI 2011AA
C0205653
SNOMED CT 2011_0131
133937008
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
UMLS CUI 2011AA
C0039685
SNOMED CT 2011_0131
86299006
MedDRA 14.1
10016193
ICD-10-CM Version 2010
Q21.3
ICD-9-CM Version 2011
745.2
UMLS CUI 2011AA
C0719519
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
C0205170
SNOMED CT 2011_0131
20572008
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0374711
SNOMED CT 2011_0131
4365001
UMLS CUI 2011AA
C0205170
SNOMED CT 2011_0131
20572008
UMLS CUI 2011AA
C0080311
SNOMED CT 2011_0131
250938005
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
pregnancy or lactation
Description

pregnancy or lactation

Data type

boolean

Alias
UMLS CUI 2011AA
C0032961
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
UMLS CUI 2011AA
C0006147
MedDRA 14.1
10006247
women of child-bearing age who are sexually active without practising highly effective methods of contraception (a urine/serum pregnancy test may be requested at the discretion of the investigator)
Description

women of child-bearing age who are sexually active without practising highly effective methods of contraception (a urine/serum pregnancy test may be requested at the discretion of the investigator)

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
UMLS CUI 2011AA
C0241028
SNOMED CT 2011_0131
228453005
MedDRA 14.1
10066098
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C1704419
SNOMED CT 2011_0131
254648000
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
UMLS CUI 2011AA
C0430056
SNOMED CT 2011_0131
167252002
MedDRA 14.1
10036576
UMLS CUI 2011AA
C0430060
SNOMED CT 2011_0131
166434005
UMLS CUI 2011AA
C1272683
SNOMED CT 2011_0131
385644000
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
any diseases or impairment that, in the opinion of the investigator, would justify to exclude a subject from participation
Description

any diseases or impairment that, in the opinion of the investigator, would justify to exclude a subject from participation

Data type

boolean

Alias
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0221099
SNOMED CT 2011_0131
260379002
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
CL425201
UMLS CUI 2011AA
C2348568
substance abuse (alcohol, medicines, drugs)
Description

Substance abuse

Data type

boolean

Alias
UMLS CUI-1
C0740858
SNOMED CT 2011_0131
66214007
MedDRA 14.1
10066169
LOINC Version 232
MTHU019364
SNOMED CT 2011_0131
15167005
MedDRA 14.1
10001584
LOINC Version 232
LP36309-0
ICD-10-CM Version 2010
F10.1
ICD-9-CM Version 2011
305.0
SNOMED CT 2011_0131
417928002
MedDRA 14.1
10000341
SNOMED CT 2011_0131
26416006
MedDRA 14.1
10013654
LOINC Version 232
LP36310-8
ICD-9-CM Version 2011
305.90
other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
Description

other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated

Data type

boolean

Alias
UMLS CUI 2011AA
C0205476
SNOMED CT 2011_0131
74188005
UMLS CUI 2011AA
C0205486
SNOMED CT 2011_0131
60224009
UMLS CUI 2011AA
C0683578
UMLS CUI 2011AA
C0851364
MedDRA 14.1
10041244
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
CL415098
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0205217
HL7 V3 2006_05
U
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
insufficient compliance
Description

insufficient compliance

Data type

boolean

Alias
UMLS CUI 2011AA
C1321605
disagreement with storage & transfer of anonymized disease data within this study.
Description

disagreement with storage & transfer of anonymized disease data within this study.

Data type

boolean

Alias
UMLS CUI 2011AA
CL415046
UMLS CUI 2011AA
C1698986
SNOMED CT 2011_0131
440276004
HL7 V3 2006_05
STORE
UMLS CUI 2011AA
C1705822
LOINC Version 232
MTHU034962
UMLS CUI 2011AA
C2346787
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C1511726
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Persons who are detained officially or legally to an official institution
Description

Persons who are detained officially or legally to an official institution

Data type

boolean

Alias
UMLS CUI 2011AA
C0027361
SNOMED CT 2011_0131
125676002
HL7 V3 2006_05
PSN
UMLS CUI 2011AA
C1516050
UMLS CUI 2011AA
C2347387
UMLS CUI 2011AA
C1301860
SNOMED CT 2011_0131
398165009
UMLS CUI 2011AA
C2347387
UMLS CUI 2011AA
C0021622
contraindication against pharmacological stress testing (ventricular tachycardia or severe arrhythmia, profound pulmonary stenosis and hypertension of the pulmonary artery)
Description

contraindication against pharmacological stress testing (ventricular tachycardia or severe arrhythmia, profound pulmonary stenosis and hypertension of the pulmonary artery)

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C1096540
MedDRA 14.1
10054017
UMLS CUI 2011AA
C0042514
SNOMED CT 2011_0131
25569003
MedDRA 14.1
10047302
ICD-10-CM Version 2010
I47.2
CTCAE 1105E
E10239
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0003811
SNOMED CT 2011_0131
44808001
MedDRA 14.1
10003119
ICD-9-CM Version 2011
427.9
UMLS CUI 2011AA
C1956257
UMLS CUI 2011AA
C0020542
Coronary artery disease (CAD)
Description

coronary heart disease

Data type

boolean

Alias
UMLS CUI 2011AA
C0010068
SNOMED CT 2011_0131
53741008
MedDRA 14.1
10068617
atrial fibrillation or flutter
Description

atrial fibrillation or flutter

Data type

boolean

Alias
UMLS CUI 2011AA
C0004238
SNOMED CT 2011_0131
49436004
MedDRA 14.1
10003658
ICD-10-CM Version 2010
I48.0
CTCAE 1105E
E10081
UMLS CUI 2011AA
C0004239
SNOMED CT 2011_0131
5370000
MedDRA 14.1
10003662
ICD-10-CM Version 2010
I48.1
ICD-9-CM Version 2011
427.32
CTCAE 1105E
E10087
DORV (if there is another VSD than subaortic)
Description

DORV (if there is another VSD than subaortic)

Data type

boolean

Alias
UMLS CUI 2011AA
C0013069
SNOMED CT 2011_0131
7484005
MedDRA 14.1
10013611
ICD-10-CM Version 2010
Q20.1
ICD-9-CM Version 2011
745.11
associated severe heart defects
Description

associated severe heart defects

Data type

boolean

Alias
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0018798
SNOMED CT 2011_0131
13213009
MedDRA 14.1
10002626
ICD-10-CM Version 2010
Q24.9
ICD-9-CM Version 2011
746.9
associated other severe (=hemodynamic significantly) valvular defects except for pulmonary insufficiency
Description

associated other severe (=hemodynamic significantly) valvular defects except for pulmonary insufficiency

Data type

boolean

Alias
UMLS CUI 2011AA
C0332281
SNOMED CT 2011_0131
47429007
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0019010
UMLS CUI 2011AA
C0750502
SNOMED CT 2011_0131
386134007
UMLS CUI 2011AA
C2748945
UMLS CUI 2011AA
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
CL355398
Other clinically relevant diseases, such as malignant tumour or florid diseases (as considered by the investigating physician)
Description

Other clinically relevant diseases, such as malignant tumour or florid diseases (as considered by the investigating physician)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C2347946
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C1395952
UMLS CUI 2011AA
C0022423
SNOMED CT 2011_0131
61254005
UMLS CUI 2011AA
CL102947
MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetisable foreign bodies
Description

MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetisable foreign bodies

Data type

boolean

Alias
UMLS CUI 2011AA
C0024485
SNOMED CT 2011_0131
113091000
MedDRA 14.1
10028049
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0030163
SNOMED CT 2011_0131
14106009
LOINC Version 232
MTHU024521
UMLS CUI 2011AA
C2048402
UMLS CUI 2011AA
C0563532
SNOMED CT 2011_0131
285650006
UMLS CUI 2011AA
C0016542
SNOMED CT 2011_0131
125670008
MedDRA 14.1
10070245
Patient is not able to perform spiroergometry (bicycle/treadmill) or existing contraindications
Description

Patient is not able to perform spiroergometry (bicycle/treadmill) or existing contraindications

Data type

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C0884358
SNOMED CT 2011_0131
398166005
UMLS CUI 2011AA
C0085143
UMLS CUI 2011AA
C0005375
SNOMED CT 2011_0131
70224005
UMLS CUI 2011AA
C0184069
SNOMED CT 2011_0131
1211003
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
Patients with Type I or II diabetes
Description

Patients with Type I or II diabetes

Data type

boolean

Alias
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
C0011860
SNOMED CT 2011_0131
44054006
MedDRA 14.1
10012613
ICD-10-CM Version 2010
E08-E13
prohibited concomitant medication: MAO-inhibitors
Description

prohibited concomitant medication: MAO-inhibitors

Data type

boolean

Alias
UMLS CUI 2011AA
C2347852
UMLS CUI 2011AA
C0026457
Treatment with beta- or alpha-blocker
Description

Treatment with beta- or alpha-blocker

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0001645
SNOMED CT 2011_0131
33252009
LOINC Version 232
MTHU003324
UMLS CUI 2011AA
C0001641
SNOMED CT 2011_0131
373275009
Treatment with high doses of ACE-inhibitors or inhibitors of the AT-receptor and permanent treatment with nitrates (in the investigating physician's risk assessment)
Description

Treatment with high doses of ACE-inhibitors or inhibitors of the AT-receptor and permanent treatment with nitrates (in the investigating physician's risk assessment)

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0444956
SNOMED CT 2011_0131
261829003
UMLS CUI 2011AA
C0003015
SNOMED CT 2011_0131
372733002
UMLS CUI 2011AA
C0243077
UMLS CUI 2011AA
C0815017
UMLS CUI 2011AA
C0205355
SNOMED CT 2011_0131
6934004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0028125
SNOMED CT 2011_0131
89119000
LOINC Version 232
MTHU003455
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C0524785
Anticoagulation treatment (risk-benefit decision by the investigating physician, as there may be additional inhibition of platelet aggregation with dobutamine)
Description

Anticoagulation treatment (risk-benefit decision by the investigating physician, as there may be additional inhibition of platelet aggregation with dobutamine)

Data type

boolean

Alias
UMLS CUI 2011AA
C0449867
SNOMED CT 2011_0131
260678004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0524785
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C1524062
LOINC Version 232
MTHU013802
UMLS CUI 2011AA
C0021469
SNOMED CT 2011_0131
61511001
UMLS CUI 2011AA
C0032176
SNOMED CT 2011_0131
60649002
UMLS CUI 2011AA
C0012963
SNOMED CT 2011_0131
387145002
LOINC Version 232
MTHU008963
Treatment with diuretics (risk-benefit decision by the investigating physician, as there may be enhancement of the hypokalemia by administration of dobutamine). If necessary verification of the serum K+ -level before exposure to dobutamine
Description

Treatment with diuretics (risk-benefit decision by the investigating physician, as there may be enhancement of the hypokalemia by administration of dobutamine). If necessary verification of the serum K+ -level before exposure to dobutamine

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0012798
SNOMED CT 2011_0131
372695000
LOINC Version 232
MTHU003217
UMLS CUI 2011AA
C0524785
UMLS CUI 2011AA
CL102947
UMLS CUI 2011AA
C2349975
UMLS CUI 2011AA
C0020621
SNOMED CT 2011_0131
43339004
MedDRA 14.1
10021015
ICD-10-CM Version 2010
E87.6
ICD-9-CM Version 2011
276.8
CTCAE 1105E
E12327
UMLS CUI 2011AA
C1533734
SNOMED CT 2011_0131
416118004
UMLS CUI 2011AA
C0012963
SNOMED CT 2011_0131
387145002
LOINC Version 232
MTHU008963
UMLS CUI 2011AA
C1711411
UMLS CUI 2011AA
C0202194
SNOMED CT 2011_0131
59573005
MedDRA 14.1
10023272
UMLS CUI 2011AA
C0332157
SNOMED CT 2011_0131
24932003
all contraindications against the study medication described in the SMPC
Description

all contraindications against the study medication described in the SMPC

Data type

boolean

Alias
UMLS CUI 2011AA
C1301624
SNOMED CT 2011_0131
397745006
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013227
UMLS CUI 2011AA
C1709515
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 14 Years
Item
age at least 14 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Written informed consent of the patient or patient's legal representatives
Item
Written informed consent of the patient or patient's legal representatives
boolean
C0021430 (UMLS CUI 2011AA)
No participation in another AMG driven study within the past 4 weeks or during the whole duration of this study
Item
No participation in another AMG driven study within the past 4 weeks or during the whole duration of this study
boolean
C1518422 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0449238 (UMLS CUI 2011AA)
103335007 (SNOMED CT 2011_0131)
MTHU001938 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Patients with Tetralogy of Fallot after corrective surgery
Item
Patients with Tetralogy of Fallot after corrective surgery
boolean
C0039685 (UMLS CUI 2011AA)
86299006 (SNOMED CT 2011_0131)
10016193 (MedDRA 14.1)
Q21.3 (ICD-10-CM Version 2010)
745.2 (ICD-9-CM Version 2011)
C0719519 (UMLS CUI 2011AA)
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
group A (n=45): Adolescents >= 14 years or adults with Tetralogy of Fallot after corrective surgery and necessary re-intervention (pulmonary valve replacement because of pulmonary insufficiency
Item
group A (n=45): Adolescents >= 14 years or adults with Tetralogy of Fallot after corrective surgery and necessary re-intervention (pulmonary valve replacement because of pulmonary insufficiency
boolean
CL415249 (UMLS CUI 2011AA)
RGRP (HL7 V3 2006_05)
C0205653 (UMLS CUI 2011AA)
133937008 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
C0039685 (UMLS CUI 2011AA)
86299006 (SNOMED CT 2011_0131)
10016193 (MedDRA 14.1)
Q21.3 (ICD-10-CM Version 2010)
745.2 (ICD-9-CM Version 2011)
C0719519 (UMLS CUI 2011AA)
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C0205341 (UMLS CUI 2011AA)
27582007 (SNOMED CT 2011_0131)
C1948041 (UMLS CUI 2011AA)
71388002 (SNOMED CT 2011_0131)
10042613 (MedDRA 14.1)
MTHU006237 (LOINC Version 232)
00-99.99 (ICD-9-CM Version 2011)
C0190129 (UMLS CUI 2011AA)
88045004 (SNOMED CT 2011_0131)
10037449 (MedDRA 14.1)
CL355398 (UMLS CUI 2011AA)
group B (n=35): Adolescents >= 14 years or adults with Tetralogy of Fallot after corrective surgery and good result of repair and good right ventricular function
Item
group B (n=35): Adolescents >= 14 years or adults with Tetralogy of Fallot after corrective surgery and good result of repair and good right ventricular function
boolean
CL415249 (UMLS CUI 2011AA)
C0205653 (UMLS CUI 2011AA)
133937008 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
C0039685 (UMLS CUI 2011AA)
86299006 (SNOMED CT 2011_0131)
10016193 (MedDRA 14.1)
Q21.3 (ICD-10-CM Version 2010)
745.2 (ICD-9-CM Version 2011)
C0719519 (UMLS CUI 2011AA)
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0374711 (UMLS CUI 2011AA)
4365001 (SNOMED CT 2011_0131)
C0205170 (UMLS CUI 2011AA)
20572008 (SNOMED CT 2011_0131)
C0080311 (UMLS CUI 2011AA)
250938005 (SNOMED CT 2011_0131)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
pregnancy or lactation
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
C0006147 (UMLS CUI 2011AA)
10006247 (MedDRA 14.1)
women of child-bearing age who are sexually active without practising highly effective methods of contraception (a urine/serum pregnancy test may be requested at the discretion of the investigator)
Item
women of child-bearing age who are sexually active without practising highly effective methods of contraception (a urine/serum pregnancy test may be requested at the discretion of the investigator)
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
C0241028 (UMLS CUI 2011AA)
228453005 (SNOMED CT 2011_0131)
10066098 (MedDRA 14.1)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C1704419 (UMLS CUI 2011AA)
254648000 (SNOMED CT 2011_0131)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0430056 (UMLS CUI 2011AA)
167252002 (SNOMED CT 2011_0131)
10036576 (MedDRA 14.1)
C0430060 (UMLS CUI 2011AA)
166434005 (SNOMED CT 2011_0131)
C1272683 (UMLS CUI 2011AA)
385644000 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
any diseases or impairment that, in the opinion of the investigator, would justify to exclude a subject from participation
Item
any diseases or impairment that, in the opinion of the investigator, would justify to exclude a subject from participation
boolean
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0221099 (UMLS CUI 2011AA)
260379002 (SNOMED CT 2011_0131)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
CL425201 (UMLS CUI 2011AA)
C2348568 (UMLS CUI 2011AA)
Substance abuse
Item
substance abuse (alcohol, medicines, drugs)
boolean
C0740858 (UMLS CUI-1)
66214007 (SNOMED CT 2011_0131)
10066169 (MedDRA 14.1)
MTHU019364 (LOINC Version 232)
15167005 (SNOMED CT 2011_0131)
10001584 (MedDRA 14.1)
LP36309-0 (LOINC Version 232)
F10.1 (ICD-10-CM Version 2010)
305.0 (ICD-9-CM Version 2011)
417928002 (SNOMED CT 2011_0131)
10000341 (MedDRA 14.1)
26416006 (SNOMED CT 2011_0131)
10013654 (MedDRA 14.1)
LP36310-8 (LOINC Version 232)
305.90 (ICD-9-CM Version 2011)
other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
Item
other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
boolean
C0205476 (UMLS CUI 2011AA)
74188005 (SNOMED CT 2011_0131)
C0205486 (UMLS CUI 2011AA)
60224009 (SNOMED CT 2011_0131)
C0683578 (UMLS CUI 2011AA)
C0851364 (UMLS CUI 2011AA)
10041244 (MedDRA 14.1)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
CL415098 (UMLS CUI 2011AA)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0205217 (UMLS CUI 2011AA)
U (HL7 V3 2006_05)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
insufficient compliance
Item
insufficient compliance
boolean
C1321605 (UMLS CUI 2011AA)
disagreement with storage & transfer of anonymized disease data within this study.
Item
disagreement with storage & transfer of anonymized disease data within this study.
boolean
CL415046 (UMLS CUI 2011AA)
C1698986 (UMLS CUI 2011AA)
440276004 (SNOMED CT 2011_0131)
STORE (HL7 V3 2006_05)
C1705822 (UMLS CUI 2011AA)
MTHU034962 (LOINC Version 232)
C2346787 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C1511726 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Persons who are detained officially or legally to an official institution
Item
Persons who are detained officially or legally to an official institution
boolean
C0027361 (UMLS CUI 2011AA)
125676002 (SNOMED CT 2011_0131)
PSN (HL7 V3 2006_05)
C1516050 (UMLS CUI 2011AA)
C2347387 (UMLS CUI 2011AA)
C1301860 (UMLS CUI 2011AA)
398165009 (SNOMED CT 2011_0131)
C2347387 (UMLS CUI 2011AA)
C0021622 (UMLS CUI 2011AA)
contraindication against pharmacological stress testing (ventricular tachycardia or severe arrhythmia, profound pulmonary stenosis and hypertension of the pulmonary artery)
Item
contraindication against pharmacological stress testing (ventricular tachycardia or severe arrhythmia, profound pulmonary stenosis and hypertension of the pulmonary artery)
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C1096540 (UMLS CUI 2011AA)
10054017 (MedDRA 14.1)
C0042514 (UMLS CUI 2011AA)
25569003 (SNOMED CT 2011_0131)
10047302 (MedDRA 14.1)
I47.2 (ICD-10-CM Version 2010)
E10239 (CTCAE 1105E)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0003811 (UMLS CUI 2011AA)
44808001 (SNOMED CT 2011_0131)
10003119 (MedDRA 14.1)
427.9 (ICD-9-CM Version 2011)
C1956257 (UMLS CUI 2011AA)
C0020542 (UMLS CUI 2011AA)
coronary heart disease
Item
Coronary artery disease (CAD)
boolean
C0010068 (UMLS CUI 2011AA)
53741008 (SNOMED CT 2011_0131)
10068617 (MedDRA 14.1)
atrial fibrillation or flutter
Item
atrial fibrillation or flutter
boolean
C0004238 (UMLS CUI 2011AA)
49436004 (SNOMED CT 2011_0131)
10003658 (MedDRA 14.1)
I48.0 (ICD-10-CM Version 2010)
E10081 (CTCAE 1105E)
C0004239 (UMLS CUI 2011AA)
5370000 (SNOMED CT 2011_0131)
10003662 (MedDRA 14.1)
I48.1 (ICD-10-CM Version 2010)
427.32 (ICD-9-CM Version 2011)
E10087 (CTCAE 1105E)
DORV (if there is another VSD than subaortic)
Item
DORV (if there is another VSD than subaortic)
boolean
C0013069 (UMLS CUI 2011AA)
7484005 (SNOMED CT 2011_0131)
10013611 (MedDRA 14.1)
Q20.1 (ICD-10-CM Version 2010)
745.11 (ICD-9-CM Version 2011)
associated severe heart defects
Item
associated severe heart defects
boolean
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0018798 (UMLS CUI 2011AA)
13213009 (SNOMED CT 2011_0131)
10002626 (MedDRA 14.1)
Q24.9 (ICD-10-CM Version 2010)
746.9 (ICD-9-CM Version 2011)
associated other severe (=hemodynamic significantly) valvular defects except for pulmonary insufficiency
Item
associated other severe (=hemodynamic significantly) valvular defects except for pulmonary insufficiency
boolean
C0332281 (UMLS CUI 2011AA)
47429007 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0019010 (UMLS CUI 2011AA)
C0750502 (UMLS CUI 2011AA)
386134007 (SNOMED CT 2011_0131)
C2748945 (UMLS CUI 2011AA)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
CL355398 (UMLS CUI 2011AA)
Other clinically relevant diseases, such as malignant tumour or florid diseases (as considered by the investigating physician)
Item
Other clinically relevant diseases, such as malignant tumour or florid diseases (as considered by the investigating physician)
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C2347946 (UMLS CUI 2011AA)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C1395952 (UMLS CUI 2011AA)
C0022423 (UMLS CUI 2011AA)
61254005 (SNOMED CT 2011_0131)
CL102947 (UMLS CUI 2011AA)
MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetisable foreign bodies
Item
MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetisable foreign bodies
boolean
C0024485 (UMLS CUI 2011AA)
113091000 (SNOMED CT 2011_0131)
10028049 (MedDRA 14.1)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0030163 (UMLS CUI 2011AA)
14106009 (SNOMED CT 2011_0131)
MTHU024521 (LOINC Version 232)
C2048402 (UMLS CUI 2011AA)
C0563532 (UMLS CUI 2011AA)
285650006 (SNOMED CT 2011_0131)
C0016542 (UMLS CUI 2011AA)
125670008 (SNOMED CT 2011_0131)
10070245 (MedDRA 14.1)
Patient is not able to perform spiroergometry (bicycle/treadmill) or existing contraindications
Item
Patient is not able to perform spiroergometry (bicycle/treadmill) or existing contraindications
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C0884358 (UMLS CUI 2011AA)
398166005 (SNOMED CT 2011_0131)
C0085143 (UMLS CUI 2011AA)
C0005375 (UMLS CUI 2011AA)
70224005 (SNOMED CT 2011_0131)
C0184069 (UMLS CUI 2011AA)
1211003 (SNOMED CT 2011_0131)
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
Patients with Type I or II diabetes
Item
Patients with Type I or II diabetes
boolean
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011860 (UMLS CUI 2011AA)
44054006 (SNOMED CT 2011_0131)
10012613 (MedDRA 14.1)
E08-E13 (ICD-10-CM Version 2010)
prohibited concomitant medication: MAO-inhibitors
Item
prohibited concomitant medication: MAO-inhibitors
boolean
C2347852 (UMLS CUI 2011AA)
C0026457 (UMLS CUI 2011AA)
Treatment with beta- or alpha-blocker
Item
Treatment with beta- or alpha-blocker
boolean
C0039798 (UMLS CUI 2011AA)
C0001645 (UMLS CUI 2011AA)
33252009 (SNOMED CT 2011_0131)
MTHU003324 (LOINC Version 232)
C0001641 (UMLS CUI 2011AA)
373275009 (SNOMED CT 2011_0131)
Treatment with high doses of ACE-inhibitors or inhibitors of the AT-receptor and permanent treatment with nitrates (in the investigating physician's risk assessment)
Item
Treatment with high doses of ACE-inhibitors or inhibitors of the AT-receptor and permanent treatment with nitrates (in the investigating physician's risk assessment)
boolean
C0039798 (UMLS CUI 2011AA)
C0444956 (UMLS CUI 2011AA)
261829003 (SNOMED CT 2011_0131)
C0003015 (UMLS CUI 2011AA)
372733002 (SNOMED CT 2011_0131)
C0243077 (UMLS CUI 2011AA)
C0815017 (UMLS CUI 2011AA)
C0205355 (UMLS CUI 2011AA)
6934004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0028125 (UMLS CUI 2011AA)
89119000 (SNOMED CT 2011_0131)
MTHU003455 (LOINC Version 232)
CL102947 (UMLS CUI 2011AA)
C0524785 (UMLS CUI 2011AA)
Anticoagulation treatment (risk-benefit decision by the investigating physician, as there may be additional inhibition of platelet aggregation with dobutamine)
Item
Anticoagulation treatment (risk-benefit decision by the investigating physician, as there may be additional inhibition of platelet aggregation with dobutamine)
boolean
C0449867 (UMLS CUI 2011AA)
260678004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0524785 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
C1524062 (UMLS CUI 2011AA)
MTHU013802 (LOINC Version 232)
C0021469 (UMLS CUI 2011AA)
61511001 (SNOMED CT 2011_0131)
C0032176 (UMLS CUI 2011AA)
60649002 (SNOMED CT 2011_0131)
C0012963 (UMLS CUI 2011AA)
387145002 (SNOMED CT 2011_0131)
MTHU008963 (LOINC Version 232)
Treatment with diuretics (risk-benefit decision by the investigating physician, as there may be enhancement of the hypokalemia by administration of dobutamine). If necessary verification of the serum K+ -level before exposure to dobutamine
Item
Treatment with diuretics (risk-benefit decision by the investigating physician, as there may be enhancement of the hypokalemia by administration of dobutamine). If necessary verification of the serum K+ -level before exposure to dobutamine
boolean
C0039798 (UMLS CUI 2011AA)
C0012798 (UMLS CUI 2011AA)
372695000 (SNOMED CT 2011_0131)
MTHU003217 (LOINC Version 232)
C0524785 (UMLS CUI 2011AA)
CL102947 (UMLS CUI 2011AA)
C2349975 (UMLS CUI 2011AA)
C0020621 (UMLS CUI 2011AA)
43339004 (SNOMED CT 2011_0131)
10021015 (MedDRA 14.1)
E87.6 (ICD-10-CM Version 2010)
276.8 (ICD-9-CM Version 2011)
E12327 (CTCAE 1105E)
C1533734 (UMLS CUI 2011AA)
416118004 (SNOMED CT 2011_0131)
C0012963 (UMLS CUI 2011AA)
387145002 (SNOMED CT 2011_0131)
MTHU008963 (LOINC Version 232)
C1711411 (UMLS CUI 2011AA)
C0202194 (UMLS CUI 2011AA)
59573005 (SNOMED CT 2011_0131)
10023272 (MedDRA 14.1)
C0332157 (UMLS CUI 2011AA)
24932003 (SNOMED CT 2011_0131)
all contraindications against the study medication described in the SMPC
Item
all contraindications against the study medication described in the SMPC
boolean
C1301624 (UMLS CUI 2011AA)
397745006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
C1709515 (UMLS CUI 2011AA)
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