ID

4463

Description

ODM derived from http://clinicaltrials.gov/show/NCT00404092

Link

http://clinicaltrials.gov/show/NCT00404092

Keywords

Versions (1)
  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00404092 Invasive Aspergillosis

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy, treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections.
Description

Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy, treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085393
SNOMED CT 2011_0131
370388006
UMLS CUI 2011AA
CL420107
UMLS CUI 2011AA
C0376545
SNOMED CT 2011_0131
129154003
MedDRA 14.1
10066476
UMLS CUI 2011AA
C2931245
UMLS CUI 2011AA
C0472699
SNOMED CT 2011_0131
234336002
UMLS CUI 2011AA
C0730400
SNOMED CT 2011_0131
313039003
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C1274040
SNOMED CT 2011_0131
79409006
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0853697
MedDRA 14.1
10029366
CTCAE 1105E
E12198
UMLS CUI 2011AA
C0019693
SNOMED CT 2011_0131
86406008
MedDRA 14.1
10020161
LOINC Version 232
MTHU020829
ICD-10-CM Version 2010
B20
ICD-9-CM Version 2011
042
UMLS CUI 2011AA
C0439590
SNOMED CT 2011_0131
255224006
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0021081
SNOMED CT 2011_0131
372823004, 69431002
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0085393
SNOMED CT 2011_0131
370388006
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
C0035647
SNOMED CT 2011_0131
30207005
HL7 V3 2006_05
RSK
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria
Description

Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria

Data type

boolean

Alias
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0456369
SNOMED CT 2011_0131
277025001
UMLS CUI 2011AA
C0332148
SNOMED CT 2011_0131
2931005
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0004030
SNOMED CT 2011_0131
65553006
MedDRA 14.1
10003488
ICD-10-CM Version 2010
B44
ICD-9-CM Version 2011
117.3
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0392747
SNOMED CT 2011_0131
243326001
UMLS CUI 2011AA
C1516985
UMLS CUI 2011AA
CL414621
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Concomitant other systemic antifungal agents are not permitted on study.
Description

Concomitant other systemic antifungal agents are not permitted on study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1554075
UMLS CUI 2011AA
CL415222
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0003308
SNOMED CT 2011_0131
373219008
Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study
Description

Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study

Data type

boolean

Alias
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
UMLS CUI 2011AA
C1704788
UMLS CUI 2011AA
C0220912
UMLS CUI 2011AA
C1457887
LOINC Version 232
MTHU021540
ICD-9-CM Version 2011
780-789.99
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0205172
SNOMED CT 2011_0131
242762006
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
Prior systemic therapy of >= 4 days with any polyene anti-fungal agent within 14 days of study enrollment
Description

Prior systemic therapy of >= 4 days with any polyene anti-fungal agent within 14 days of study enrollment

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0032473
UMLS CUI 2011AA
C0003308
SNOMED CT 2011_0131
373219008
UMLS CUI 2011AA
C0332285
SNOMED CT 2011_0131
18720000
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0439230
SNOMED CT 2011_0131
258705008
HL7 V3 2006_05
WK
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1516879
Prior systemic therapy of >= 4 days with non-polyenes for the current, documented IFI.
Description

Prior systemic therapy of >= 4 days with non-polyenes for the current, documented IFI.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1515119
UMLS CUI 2011AA
C0205450
SNOMED CT 2011_0131
9362000
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0032473
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1301725
SNOMED CT 2011_0131
397934002
UMLS CUI 2011AA
C0205281
SNOMED CT 2011_0131
10179008
UMLS CUI 2011AA
C0026946
SNOMED CT 2011_0131
3218000
MedDRA 14.1
10017533
ICD-10-CM Version 2010
B35-B49
ICD-9-CM Version 2011
110-118.99
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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 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy, treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections.
Item
Immunocompromised due to hematologic malignancies, bone marrow failure syndromes, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy, treatment with other immunosuppressive medications, or other immunocompromising conditions that place patients at risk for invasive fungal infections.
boolean
C0085393 (UMLS CUI 2011AA)
370388006 (SNOMED CT 2011_0131)
CL420107 (UMLS CUI 2011AA)
C0376545 (UMLS CUI 2011AA)
129154003 (SNOMED CT 2011_0131)
10066476 (MedDRA 14.1)
C2931245 (UMLS CUI 2011AA)
C0472699 (UMLS CUI 2011AA)
234336002 (SNOMED CT 2011_0131)
C0730400 (UMLS CUI 2011AA)
313039003 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C1274040 (UMLS CUI 2011AA)
79409006 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0853697 (UMLS CUI 2011AA)
10029366 (MedDRA 14.1)
E12198 (CTCAE 1105E)
C0019693 (UMLS CUI 2011AA)
86406008 (SNOMED CT 2011_0131)
10020161 (MedDRA 14.1)
MTHU020829 (LOINC Version 232)
B20 (ICD-10-CM Version 2010)
042 (ICD-9-CM Version 2011)
C0439590 (UMLS CUI 2011AA)
255224006 (SNOMED CT 2011_0131)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0021081 (UMLS CUI 2011AA)
372823004, 69431002 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0085393 (UMLS CUI 2011AA)
370388006 (SNOMED CT 2011_0131)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0035647 (UMLS CUI 2011AA)
30207005 (SNOMED CT 2011_0131)
RSK (HL7 V3 2006_05)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria
Item
Evidence of proven or probable invasive aspergillosis, by modified EORTC criteria
boolean
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0456369 (UMLS CUI 2011AA)
277025001 (SNOMED CT 2011_0131)
C0332148 (UMLS CUI 2011AA)
2931005 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0004030 (UMLS CUI 2011AA)
65553006 (SNOMED CT 2011_0131)
10003488 (MedDRA 14.1)
B44 (ICD-10-CM Version 2010)
117.3 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0392747 (UMLS CUI 2011AA)
243326001 (SNOMED CT 2011_0131)
C1516985 (UMLS CUI 2011AA)
CL414621 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Concomitant other systemic antifungal agents are not permitted on study.
Item
Concomitant other systemic antifungal agents are not permitted on study.
boolean
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1554075 (UMLS CUI 2011AA)
CL415222 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study
Item
Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study
boolean
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
C1704788 (UMLS CUI 2011AA)
C0220912 (UMLS CUI 2011AA)
C1457887 (UMLS CUI 2011AA)
MTHU021540 (LOINC Version 232)
780-789.99 (ICD-9-CM Version 2011)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0205172 (UMLS CUI 2011AA)
242762006 (SNOMED CT 2011_0131)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
Prior systemic therapy of >= 4 days with any polyene anti-fungal agent within 14 days of study enrollment
Item
Prior systemic therapy of >= 4 days with any polyene anti-fungal agent within 14 days of study enrollment
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0032473 (UMLS CUI 2011AA)
C0003308 (UMLS CUI 2011AA)
373219008 (SNOMED CT 2011_0131)
C0332285 (UMLS CUI 2011AA)
18720000 (SNOMED CT 2011_0131)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0439230 (UMLS CUI 2011AA)
258705008 (SNOMED CT 2011_0131)
WK (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1516879 (UMLS CUI 2011AA)
Prior systemic therapy of >= 4 days with non-polyenes for the current, documented IFI.
Item
Prior systemic therapy of >= 4 days with non-polyenes for the current, documented IFI.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1515119 (UMLS CUI 2011AA)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C1518422 (UMLS CUI 2011AA)
C0032473 (UMLS CUI 2011AA)
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1301725 (UMLS CUI 2011AA)
397934002 (SNOMED CT 2011_0131)
C0205281 (UMLS CUI 2011AA)
10179008 (SNOMED CT 2011_0131)
C0026946 (UMLS CUI 2011AA)
3218000 (SNOMED CT 2011_0131)
10017533 (MedDRA 14.1)
B35-B49 (ICD-10-CM Version 2010)
110-118.99 (ICD-9-CM Version 2011)
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