ID

4576

Beschrijving

The study compares the safety, efficacy and pharmacokinetics of caspofungin, liposomal amphotericin B or the combination of both in the antifungal treatment of adult patients after allogeneic haematopoietic stem-cell transplantation with granulocytopenia and persistent i.g. recurrent fever under adequate antibacterial therapy.

Trefwoorden

  1. 11-12-13 11-12-13 - Martin Dugas
  2. 13-04-21 13-04-21 - Dr. rer. medic Philipp Neuhaus
Geüploaded op

11 december 2013

DOI

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Licentie

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00148148 # Stem-Cell Transplantation

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beschrijving

Einschlusskriterien

Age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Gender
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LNC
MTHU002975
Healthy Volunteers
Beschrijving

Healthy Volunteers

Datatype

boolean

Alias
UMLS CUI
C1708335
InclusionCriterion_1
Beschrijving

InclusionCriterion_1

Datatype

boolean

Alias
UMLS CUI
C0027947
ICD10CM
D70
ICD9CM
288.0
MDR
10029354
SNOMED CT 2010_0731
165517008
UMLS CUI
C0948762
MDR
10052033
UMLS CUI
C2674490
UMLS CUI
C2242529
MDR
10067862
UMLS CUI
C0521304
SNOMED CT 2010_0731
7447008
UMLS CUI
C0010592
LNC
MTHU005140
SNOMED CT 2010_0731
80906007
InclusionCriterion_2
Beschrijving

InclusionCriterion_2

Datatype

boolean

Alias
UMLS CUI
C0015967
CTCAE
E11102
ICD10CM
R50.9
ICD9CM
780.60
LNC
MTHU013518
MDR
10037660
SNOMED CT 2010_0731
386661006
UMLS CUI
C0424767
SNOMED CT 2010_0731
271751000
UMLS CUI
C0277799
MDR
10058698
SNOMED CT 2010_0731
77957000
UMLS CUI
C0027947
ICD10CM
D70
ICD9CM
288.0
MDR
10029354
SNOMED CT 2010_0731
165517008
UMLS CUI
C0948762
MDR
10052033
UMLS CUI
C2674490
UMLS CUI
C0854606
MDR
10042933
InclusionCriterion_3
Beschrijving

InclusionCriterion_3

Datatype

boolean

Alias
UMLS CUI
C0007435
MDR
10053377
InclusionCriterion_4
Beschrijving

InclusionCriterion_4

Datatype

boolean

Alias
UMLS CUI
C0232805
SNOMED CT 2010_0731
81141003
UMLS CUI
C1848676
InclusionCriterion_5
Beschrijving

InclusionCriterion_5

Datatype

boolean

Alias
UMLS CUI
C0427780
MDR
10036574
SNOMED CT 2010_0731
250425007
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
InclusionCriterion_6
Beschrijving

InclusionCriterion_6

Datatype

boolean

Alias
UMLS CUI
C0021430
Ausschlusskriterien
Beschrijving

Ausschlusskriterien

ExclusionCriterion_1
Beschrijving

ExclusionCriterion_1

Datatype

boolean

Alias
UMLS CUI
C1262313
MDR
10062642
ExclusionCriterion_2
Beschrijving

ExclusionCriterion_2

Datatype

boolean

Alias
UMLS CUI
C0151746
MDR
10038451
SNOMED CT 2010_0731
39539005
UMLS CUI
C0086565
MDR
10019670
SNOMED CT 2010_0731
75183008
ExclusionCriterion_3
Beschrijving

ExclusionCriterion_3

Datatype

boolean

Alias
UMLS CUI
C0948441
MDR
10062173
ExclusionCriterion_4
Beschrijving

ExclusionCriterion_4

Datatype

boolean

Alias
UMLS CUI
C0948268
MDR
10052076
SNOMED CT 2010_0731
422773005
UMLS CUI
C0023671
LNC
MTHU021387
ExclusionCriterion_5
Beschrijving

ExclusionCriterion_5

Datatype

boolean

Alias
UMLS CUI
C0035608
LNC
MTHU008474
SNOMED CT 2010_0731
387159009
UMLS CUI
C0031507
LNC
MTHU002993
SNOMED CT 2010_0731
387220006
UMLS CUI
C0006949
LNC
MTHU003352
SNOMED CT 2010_0731
40820003
UMLS CUI
C0031412
LNC
MTHU003431
SNOMED CT 2010_0731
51073002
UMLS CUI
C0011777
LNC
MTHU004621
SNOMED CT 2010_0731
7561000
UMLS CUI
C0674428
LNC
MTHU013845
SNOMED CT 2010_0731
116078005
UMLS CUI
C0132326
LNC
MTHU013861
SNOMED CT 2010_0731
108704001
ExclusionCriterion_6
Beschrijving

ExclusionCriterion_6

Datatype

boolean

Alias
UMLS CUI
C0013182
HL7V3.0
DALG
ICD10CM
T88.7
MDR
10013700
SNOMED CT 2010_0731
416098002
UMLS CUI
C0571255
SNOMED CT 2010_0731
294340008
UMLS CUI
C1268551
SNOMED CT 2010_0731
129473008
UMLS CUI
C0002679
LNC
MTHU006779
SNOMED CT 2010_0731
77703004
UMLS CUI
C0571263
SNOMED CT 2010_0731
294349009
ExclusionCriterion_7
Beschrijving

ExclusionCriterion_7

Datatype

boolean

Alias
UMLS CUI
CL102947
ExclusionCriterion_8
Beschrijving

ExclusionCriterion_8

Datatype

boolean

Alias
UMLS CUI
C1516879
Medizinische Konzepte
Beschrijving

Medizinische Konzepte

Age
Beschrijving

Age

Datatype

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Gender
Beschrijving

Gender

Datatype

string

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LNC
MTHU002975
Healthy Subject
Beschrijving

Healthy Subject

Datatype

string

Alias
UMLS CUI
C1708335
Neutropenia
Beschrijving

Neutropenia

Datatype

string

Alias
UMLS CUI
C0027947
ICD10CM
D70
ICD9CM
288.0
MDR
10029354
SNOMED CT 2010_0731
165517008
Absolute Neutrophil Count
Beschrijving

Absolute Neutrophil Count

Datatype

string

Alias
UMLS CUI
C0948762
MDR
10052033
Low peripheral neutrophil counts (absolute neutrophil count less than 500/microliter)
Beschrijving

Low peripheral neutrophil counts (absolute neutrophil count less than 500/microliter)

Datatype

string

Alias
UMLS CUI
C2674490
Allogeneic Hematopoietic Stem Cell Transplantation
Beschrijving

Allogeneic Hematopoietic Stem Cell Transplantation

Datatype

string

Alias
UMLS CUI
C2242529
MDR
10067862
Immunosuppressive therapy for transplant
Beschrijving

Immunosuppressive therapy for transplant

Datatype

string

Alias
UMLS CUI
C0521304
SNOMED CT 2010_0731
7447008
Cyclosporine
Beschrijving

Cyclosporine

Datatype

string

Alias
UMLS CUI
C0010592
LNC
MTHU005140
SNOMED CT 2010_0731
80906007
Fever
Beschrijving

Fever

Datatype

string

Alias
UMLS CUI
C0015967
CTCAE
E11102
ICD10CM
R50.9
ICD9CM
780.60
LNC
MTHU013518
MDR
10037660
SNOMED CT 2010_0731
386661006
Continuous fever
Beschrijving

Continuous fever

Datatype

string

Alias
UMLS CUI
C0424767
SNOMED CT 2010_0731
271751000
Intermittent Pyrexia
Beschrijving

Intermittent Pyrexia

Datatype

string

Alias
UMLS CUI
C0277799
MDR
10058698
SNOMED CT 2010_0731
77957000
Systemic antibacterial therapy
Beschrijving

Systemic antibacterial therapy

Datatype

string

Alias
UMLS CUI
C0854606
MDR
10042933
Catheterization, Central Venous
Beschrijving

Catheterization, Central Venous

Datatype

string

Alias
UMLS CUI
C0007435
MDR
10053377
Normal renal function
Beschrijving

Normal renal function

Datatype

string

Alias
UMLS CUI
C0232805
SNOMED CT 2010_0731
81141003
Normal liver function
Beschrijving

Normal liver function

Datatype

string

Alias
UMLS CUI
C1848676
Negative Pregnancy Test
Beschrijving

Negative Pregnancy Test

Datatype

string

Alias
UMLS CUI
C0427780
MDR
10036574
SNOMED CT 2010_0731
250425007
Contraceptive methods
Beschrijving

Contraceptive methods

Datatype

string

Alias
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
Informed Consent
Beschrijving

Informed Consent

Datatype

string

Alias
UMLS CUI
C0021430
Invasive mycosis
Beschrijving

Invasive mycosis

Datatype

string

Alias
UMLS CUI
C1262313
MDR
10062642
Abnormal renal function
Beschrijving

Abnormal renal function

Datatype

string

Alias
UMLS CUI
C0151746
MDR
10038451
SNOMED CT 2010_0731
39539005
Liver Dysfunction
Beschrijving

Liver Dysfunction

Datatype

string

Alias
UMLS CUI
C0086565
MDR
10019670
SNOMED CT 2010_0731
75183008
Venoocclusive disease
Beschrijving

Venoocclusive disease

Datatype

string

Alias
UMLS CUI
C0948441
MDR
10062173
Hemodynamic instability
Beschrijving

Hemodynamic instability

Datatype

string

Alias
UMLS CUI
C0948268
MDR
10052076
SNOMED CT 2010_0731
422773005
Life Expectancy
Beschrijving

Life Expectancy

Datatype

string

Alias
UMLS CUI
C0023671
LNC
MTHU021387
Rifampin
Beschrijving

Rifampin

Datatype

string

Alias
UMLS CUI
C0035608
LNC
MTHU008474
SNOMED CT 2010_0731
387159009
Phenytoin
Beschrijving

Phenytoin

Datatype

string

Alias
UMLS CUI
C0031507
LNC
MTHU002993
SNOMED CT 2010_0731
387220006
Carbamazepine
Beschrijving

Carbamazepine

Datatype

string

Alias
UMLS CUI
C0006949
LNC
MTHU003352
SNOMED CT 2010_0731
40820003
Phenobarbital
Beschrijving

Phenobarbital

Datatype

string

Alias
UMLS CUI
C0031412
LNC
MTHU003431
SNOMED CT 2010_0731
51073002
Dexamethasone
Beschrijving

Dexamethasone

Datatype

string

Alias
UMLS CUI
C0011777
LNC
MTHU004621
SNOMED CT 2010_0731
7561000
Efavirenz
Beschrijving

Efavirenz

Datatype

string

Alias
UMLS CUI
C0674428
LNC
MTHU013845
SNOMED CT 2010_0731
116078005
Nevirapine
Beschrijving

Nevirapine

Datatype

string

Alias
UMLS CUI
C0132326
LNC
MTHU013861
SNOMED CT 2010_0731
108704001
Investigator
Beschrijving

Investigator

Datatype

string

Alias
UMLS CUI
CL102947
Enrollment
Beschrijving

Enrollment

Datatype

string

Alias
UMLS CUI
C1516879

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Einschlusskriterien
Age
Item
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Gender
Item
boolean
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
Healthy Volunteers
Item
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
boolean
C0027947 (UMLS CUI)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
C0948762 (UMLS CUI)
10052033 (MDR)
C2674490 (UMLS CUI)
C2242529 (UMLS CUI)
10067862 (MDR)
C0521304 (UMLS CUI)
7447008 (SNOMED CT 2010_0731)
C0010592 (UMLS CUI)
MTHU005140 (LNC)
80906007 (SNOMED CT 2010_0731)
InclusionCriterion_2
Item
boolean
C0015967 (UMLS CUI)
E11102 (CTCAE)
R50.9 (ICD10CM)
780.60 (ICD9CM)
MTHU013518 (LNC)
10037660 (MDR)
386661006 (SNOMED CT 2010_0731)
C0424767 (UMLS CUI)
271751000 (SNOMED CT 2010_0731)
C0277799 (UMLS CUI)
10058698 (MDR)
77957000 (SNOMED CT 2010_0731)
C0027947 (UMLS CUI)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
C0948762 (UMLS CUI)
10052033 (MDR)
C2674490 (UMLS CUI)
C0854606 (UMLS CUI)
10042933 (MDR)
InclusionCriterion_3
Item
boolean
C0007435 (UMLS CUI)
10053377 (MDR)
InclusionCriterion_4
Item
boolean
C0232805 (UMLS CUI)
81141003 (SNOMED CT 2010_0731)
C1848676 (UMLS CUI)
InclusionCriterion_5
Item
boolean
C0427780 (UMLS CUI)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
InclusionCriterion_6
Item
boolean
C0021430 (UMLS CUI)
Item Group
Ausschlusskriterien
ExclusionCriterion_1
Item
boolean
C1262313 (UMLS CUI)
10062642 (MDR)
ExclusionCriterion_2
Item
boolean
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
boolean
C0948441 (UMLS CUI)
10062173 (MDR)
ExclusionCriterion_4
Item
boolean
C0948268 (UMLS CUI)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
C0023671 (UMLS CUI)
MTHU021387 (LNC)
ExclusionCriterion_5
Item
boolean
C0035608 (UMLS CUI)
MTHU008474 (LNC)
387159009 (SNOMED CT 2010_0731)
C0031507 (UMLS CUI)
MTHU002993 (LNC)
387220006 (SNOMED CT 2010_0731)
C0006949 (UMLS CUI)
MTHU003352 (LNC)
40820003 (SNOMED CT 2010_0731)
C0031412 (UMLS CUI)
MTHU003431 (LNC)
51073002 (SNOMED CT 2010_0731)
C0011777 (UMLS CUI)
MTHU004621 (LNC)
7561000 (SNOMED CT 2010_0731)
C0674428 (UMLS CUI)
MTHU013845 (LNC)
116078005 (SNOMED CT 2010_0731)
C0132326 (UMLS CUI)
MTHU013861 (LNC)
108704001 (SNOMED CT 2010_0731)
ExclusionCriterion_6
Item
boolean
C0013182 (UMLS CUI)
DALG (HL7V3.0)
T88.7 (ICD10CM)
10013700 (MDR)
416098002 (SNOMED CT 2010_0731)
C0571255 (UMLS CUI)
294340008 (SNOMED CT 2010_0731)
C1268551 (UMLS CUI)
129473008 (SNOMED CT 2010_0731)
C0002679 (UMLS CUI)
MTHU006779 (LNC)
77703004 (SNOMED CT 2010_0731)
C0571263 (UMLS CUI)
294349009 (SNOMED CT 2010_0731)
ExclusionCriterion_7
Item
boolean
CL102947 (UMLS CUI)
ExclusionCriterion_8
Item
boolean
C1516879 (UMLS CUI)
Item Group
Medizinische Konzepte
Age
Item
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Gender
Item
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
Healthy Subject
Item
string
C1708335 (UMLS CUI)
Neutropenia
Item
string
C0027947 (UMLS CUI)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
Absolute Neutrophil Count
Item
string
C0948762 (UMLS CUI)
10052033 (MDR)
Low peripheral neutrophil counts (absolute neutrophil count less than 500/microliter)
Item
string
C2674490 (UMLS CUI)
Allogeneic Hematopoietic Stem Cell Transplantation
Item
string
C2242529 (UMLS CUI)
10067862 (MDR)
Immunosuppressive therapy for transplant
Item
string
C0521304 (UMLS CUI)
7447008 (SNOMED CT 2010_0731)
Cyclosporine
Item
string
C0010592 (UMLS CUI)
MTHU005140 (LNC)
80906007 (SNOMED CT 2010_0731)
Fever
Item
string
C0015967 (UMLS CUI)
E11102 (CTCAE)
R50.9 (ICD10CM)
780.60 (ICD9CM)
MTHU013518 (LNC)
10037660 (MDR)
386661006 (SNOMED CT 2010_0731)
Continuous fever
Item
string
C0424767 (UMLS CUI)
271751000 (SNOMED CT 2010_0731)
Intermittent Pyrexia
Item
string
C0277799 (UMLS CUI)
10058698 (MDR)
77957000 (SNOMED CT 2010_0731)
Systemic antibacterial therapy
Item
string
C0854606 (UMLS CUI)
10042933 (MDR)
Catheterization, Central Venous
Item
string
C0007435 (UMLS CUI)
10053377 (MDR)
Normal renal function
Item
string
C0232805 (UMLS CUI)
81141003 (SNOMED CT 2010_0731)
Normal liver function
Item
string
C1848676 (UMLS CUI)
Negative Pregnancy Test
Item
string
C0427780 (UMLS CUI)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
Contraceptive methods
Item
string
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
Informed Consent
Item
string
C0021430 (UMLS CUI)
Invasive mycosis
Item
string
C1262313 (UMLS CUI)
10062642 (MDR)
Abnormal renal function
Item
string
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
Liver Dysfunction
Item
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Venoocclusive disease
Item
string
C0948441 (UMLS CUI)
10062173 (MDR)
Hemodynamic instability
Item
string
C0948268 (UMLS CUI)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
Life Expectancy
Item
string
C0023671 (UMLS CUI)
MTHU021387 (LNC)
Rifampin
Item
string
C0035608 (UMLS CUI)
MTHU008474 (LNC)
387159009 (SNOMED CT 2010_0731)
Phenytoin
Item
string
C0031507 (UMLS CUI)
MTHU002993 (LNC)
387220006 (SNOMED CT 2010_0731)
Carbamazepine
Item
string
C0006949 (UMLS CUI)
MTHU003352 (LNC)
40820003 (SNOMED CT 2010_0731)
Phenobarbital
Item
string
C0031412 (UMLS CUI)
MTHU003431 (LNC)
51073002 (SNOMED CT 2010_0731)
Dexamethasone
Item
string
C0011777 (UMLS CUI)
MTHU004621 (LNC)
7561000 (SNOMED CT 2010_0731)
Efavirenz
Item
string
C0674428 (UMLS CUI)
MTHU013845 (LNC)
116078005 (SNOMED CT 2010_0731)
Nevirapine
Item
string
C0132326 (UMLS CUI)
MTHU013861 (LNC)
108704001 (SNOMED CT 2010_0731)
Investigator
Item
string
CL102947 (UMLS CUI)
Enrollment
Item
string
C1516879 (UMLS CUI)

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