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Informações:
Falhas:
ID
4576
Descrição
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.
Palavras-chave
Versões (2)
- 11/12/2013 11/12/2013 - Martin Dugas
- 13/04/2021 13/04/2021 - Dr. rer. medic Philipp Neuhaus
Transferido a
11 de dezembro de 2013
DOI
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Licença
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00148148 # Stem-Cell Transplantation
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Gender
Item
boolean
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
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)
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)
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)
10053377 (MDR)
InclusionCriterion_4
Item
boolean
C0232805 (UMLS CUI)
81141003 (SNOMED CT 2010_0731)
C1848676 (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)
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)
ExclusionCriterion_1
Item
boolean
C1262313 (UMLS CUI)
10062642 (MDR)
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)
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)
10062173 (MDR)
ExclusionCriterion_4
Item
boolean
C0948268 (UMLS CUI)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
C0023671 (UMLS CUI)
MTHU021387 (LNC)
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)
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)
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)
Age
Item
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Gender
Item
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
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)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
Absolute Neutrophil Count
Item
string
C0948762 (UMLS CUI)
10052033 (MDR)
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)
10067862 (MDR)
Immunosuppressive therapy for transplant
Item
string
C0521304 (UMLS CUI)
7447008 (SNOMED CT 2010_0731)
7447008 (SNOMED CT 2010_0731)
Cyclosporine
Item
string
C0010592 (UMLS CUI)
MTHU005140 (LNC)
80906007 (SNOMED CT 2010_0731)
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)
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)
271751000 (SNOMED CT 2010_0731)
Intermittent Pyrexia
Item
string
C0277799 (UMLS CUI)
10058698 (MDR)
77957000 (SNOMED CT 2010_0731)
10058698 (MDR)
77957000 (SNOMED CT 2010_0731)
Systemic antibacterial therapy
Item
string
C0854606 (UMLS CUI)
10042933 (MDR)
10042933 (MDR)
Catheterization, Central Venous
Item
string
C0007435 (UMLS CUI)
10053377 (MDR)
10053377 (MDR)
Normal renal function
Item
string
C0232805 (UMLS CUI)
81141003 (SNOMED CT 2010_0731)
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)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
Contraceptive methods
Item
string
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
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)
10062642 (MDR)
Abnormal renal function
Item
string
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
Liver Dysfunction
Item
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Venoocclusive disease
Item
string
C0948441 (UMLS CUI)
10062173 (MDR)
10062173 (MDR)
Hemodynamic instability
Item
string
C0948268 (UMLS CUI)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
Life Expectancy
Item
string
C0023671 (UMLS CUI)
MTHU021387 (LNC)
MTHU021387 (LNC)
Rifampin
Item
string
C0035608 (UMLS CUI)
MTHU008474 (LNC)
387159009 (SNOMED CT 2010_0731)
MTHU008474 (LNC)
387159009 (SNOMED CT 2010_0731)
Phenytoin
Item
string
C0031507 (UMLS CUI)
MTHU002993 (LNC)
387220006 (SNOMED CT 2010_0731)
MTHU002993 (LNC)
387220006 (SNOMED CT 2010_0731)
Carbamazepine
Item
string
C0006949 (UMLS CUI)
MTHU003352 (LNC)
40820003 (SNOMED CT 2010_0731)
MTHU003352 (LNC)
40820003 (SNOMED CT 2010_0731)
Phenobarbital
Item
string
C0031412 (UMLS CUI)
MTHU003431 (LNC)
51073002 (SNOMED CT 2010_0731)
MTHU003431 (LNC)
51073002 (SNOMED CT 2010_0731)
Dexamethasone
Item
string
C0011777 (UMLS CUI)
MTHU004621 (LNC)
7561000 (SNOMED CT 2010_0731)
MTHU004621 (LNC)
7561000 (SNOMED CT 2010_0731)
Efavirenz
Item
string
C0674428 (UMLS CUI)
MTHU013845 (LNC)
116078005 (SNOMED CT 2010_0731)
MTHU013845 (LNC)
116078005 (SNOMED CT 2010_0731)
Nevirapine
Item
string
C0132326 (UMLS CUI)
MTHU013861 (LNC)
108704001 (SNOMED CT 2010_0731)
MTHU013861 (LNC)
108704001 (SNOMED CT 2010_0731)
Investigator
Item
string
CL102947 (UMLS CUI)
Enrollment
Item
string
C1516879 (UMLS CUI)