Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Einschlusskriterien
CL425202 (UMLS CUI 2011AA)
age at least 14 Years
Item
Alter mindestens 14 Jahre
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
Ausschlusskriterien
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)
C1832154 (UMLS CUI 2011AA)
coronary heart disease
Item
Koronare Herzerkrankung
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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