ID

42205

Descripción

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.

Palabras clave

Versiones (2)
  1. 11/12/13 11/12/13 - Martin Dugas
  2. 13/4/21 13/4/21 - Dr. rer. medic Philipp Neuhaus
Subido en

13 de abril de 2021

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00148148 # Stem-Cell Transplantation

Alemán Inglés

Eligibility

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Descripción

Inclusion criteria

18 Years and older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Male
Descripción

Gender

Tipo de datos

boolean

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LNC
MTHU002975
No Healthy Volunteers
Descripción

Healthy Volunteers

Tipo de datos

boolean

Alias
UMLS CUI
C1708335
Adults (> or = 18 years of age) with granulocytopenia (absolute number of neutrophil granulocytes [ANC]: < or = 500/µL) who have undergone allogeneic haematopoeitic stem cell transplantation and immunosuppression with cyclosporin A
Descripción

InclusionCriterion_1

Tipo de datos

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
Patients with persistent or recurrent fever (oral temperature > or = 38.0°C) and granulocytopenia (absolute neutrophil count < or = 500/µL) and adequate antibacterial therapy for > or = 36-48 hours, who need empirical antimycotic therapy
Descripción

InclusionCriterion_2

Tipo de datos

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
Already inserted at least double-lumen central venous catheter for administration of drugs and extraction of plasma samples
Descripción

InclusionCriterion_3

Tipo de datos

boolean

Alias
UMLS CUI
C0007435
MDR
10053377
Sufficient renal and hepatic function
Descripción

InclusionCriterion_4

Tipo de datos

boolean

Alias
UMLS CUI
C0232805
SNOMED CT 2010_0731
81141003
UMLS CUI
C1848676
Availability of negative pregnancy test and adequate contraceptive measures for female patients of childbearing age
Descripción

InclusionCriterion_5

Tipo de datos

boolean

Alias
UMLS CUI
C0427780
MDR
10036574
SNOMED CT 2010_0731
250425007
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
Availability of written informed consent from the patient or respectively from the legal representative after prior information
Descripción

InclusionCriterion_6

Tipo de datos

boolean

Alias
UMLS CUI
C0021430
Exclusion criteria
Descripción

Exclusion criteria

Patients with active, possible or proven (MSG-EORTC criteria) invasive fungal infection at time of enrollment
Descripción

ExclusionCriterion_1

Tipo de datos

boolean

Alias
UMLS CUI
C1262313
MDR
10062642
Patients with pathological functional renal or hepatic parameters
Descripción

ExclusionCriterion_2

Tipo de datos

boolean

Alias
UMLS CUI
C0151746
MDR
10038451
SNOMED CT 2010_0731
39539005
UMLS CUI
C0086565
MDR
10019670
SNOMED CT 2010_0731
75183008
Patients with clinical or laboratory chemical evidence of active veno-occlusive disease (VOD)
Descripción

ExclusionCriterion_3

Tipo de datos

boolean

Alias
UMLS CUI
C0948441
MDR
10062173
Hemodynamically unstable patients with a life expectancy of less than 5 days
Descripción

ExclusionCriterion_4

Tipo de datos

boolean

Alias
UMLS CUI
C0948268
MDR
10052076
SNOMED CT 2010_0731
422773005
UMLS CUI
C0023671
LNC
MTHU021387
Patients undergoing co-medication with rifampicin, phenytoin, carbamazepine, phenobarbital, dexamethasone, efavirenz and nevirapine
Descripción

ExclusionCriterion_5

Tipo de datos

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
Patients with prior known serious reaction to echinocandin-antifungal formulation or documented allergy to amphotericin B
Descripción

ExclusionCriterion_6

Tipo de datos

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
Patients with other condition or illness which, in the estimation of the investigator, distorts the study results or leads to an additional risk for the patient
Descripción

ExclusionCriterion_7

Tipo de datos

boolean

Alias
UMLS CUI
CL102947
Prior inclusion in the study
Descripción

ExclusionCriterion_8

Tipo de datos

boolean

Alias
UMLS CUI
C1516879
Medical Concepts
Descripción

Medical Concepts

Age
Descripción

Age

Tipo de datos

string

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

Gender

Tipo de datos

string

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

Healthy Subject

Tipo de datos

string

Alias
UMLS CUI
C1708335
Neutropenia
Descripción

Neutropenia

Tipo de datos

string

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

Absolute Neutrophil Count

Tipo de datos

string

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

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

Tipo de datos

string

Alias
UMLS CUI
C2674490
Allogeneic Hematopoietic Stem Cell Transplantation
Descripción

Allogeneic Hematopoietic Stem Cell Transplantation

Tipo de datos

string

Alias
UMLS CUI
C2242529
MDR
10067862
Immunosuppressive therapy for transplant
Descripción

Immunosuppressive therapy for transplant

Tipo de datos

string

Alias
UMLS CUI
C0521304
SNOMED CT 2010_0731
7447008
Cyclosporine
Descripción

Cyclosporine

Tipo de datos

string

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

Fever

Tipo de datos

string

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

Continuous fever

Tipo de datos

string

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

Intermittent Pyrexia

Tipo de datos

string

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

Systemic antibacterial therapy

Tipo de datos

string

Alias
UMLS CUI
C0854606
MDR
10042933
Catheterization, Central Venous
Descripción

Catheterization, Central Venous

Tipo de datos

string

Alias
UMLS CUI
C0007435
MDR
10053377
Normal renal function
Descripción

Normal renal function

Tipo de datos

string

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

Normal liver function

Tipo de datos

string

Alias
UMLS CUI
C1848676
Negative Pregnancy Test
Descripción

Negative Pregnancy Test

Tipo de datos

string

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

Contraceptive methods

Tipo de datos

string

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

Informed Consent

Tipo de datos

string

Alias
UMLS CUI
C0021430
Invasive mycosis
Descripción

Invasive mycosis

Tipo de datos

string

Alias
UMLS CUI
C1262313
MDR
10062642
Abnormal renal function
Descripción

Abnormal renal function

Tipo de datos

string

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

Liver Dysfunction

Tipo de datos

string

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

Venoocclusive disease

Tipo de datos

string

Alias
UMLS CUI
C0948441
MDR
10062173
Hemodynamic instability
Descripción

Hemodynamic instability

Tipo de datos

string

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

Life Expectancy

Tipo de datos

string

Alias
UMLS CUI
C0023671
LNC
MTHU021387
Rifampin
Descripción

Rifampin

Tipo de datos

string

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

Phenytoin

Tipo de datos

string

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

Carbamazepine

Tipo de datos

string

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

Phenobarbital

Tipo de datos

string

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

Dexamethasone

Tipo de datos

string

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

Efavirenz

Tipo de datos

string

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

Nevirapine

Tipo de datos

string

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

Investigator

Tipo de datos

string

Alias
UMLS CUI
CL102947
Enrollment
Descripción

Enrollment

Tipo de datos

string

Alias
UMLS CUI
C1516879
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Similar models

Eligibility

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Inclusion criteria
Age
Item
18 Years and older
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Gender
Item
Male
boolean
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
Healthy Volunteers
Item
No Healthy Volunteers
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
Adults (> or = 18 years of age) with granulocytopenia (absolute number of neutrophil granulocytes [ANC]: < or = 500/µL) who have undergone allogeneic haematopoeitic stem cell transplantation and immunosuppression with cyclosporin A
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
Patients with persistent or recurrent fever (oral temperature > or = 38.0°C) and granulocytopenia (absolute neutrophil count < or = 500/µL) and adequate antibacterial therapy for > or = 36-48 hours, who need empirical antimycotic therapy
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
Already inserted at least double-lumen central venous catheter for administration of drugs and extraction of plasma samples
boolean
C0007435 (UMLS CUI)
10053377 (MDR)
InclusionCriterion_4
Item
Sufficient renal and hepatic function
boolean
C0232805 (UMLS CUI)
81141003 (SNOMED CT 2010_0731)
C1848676 (UMLS CUI)
InclusionCriterion_5
Item
Availability of negative pregnancy test and adequate contraceptive measures for female patients of childbearing age
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
Availability of written informed consent from the patient or respectively from the legal representative after prior information
boolean
C0021430 (UMLS CUI)
Item Group
Exclusion criteria
ExclusionCriterion_1
Item
Patients with active, possible or proven (MSG-EORTC criteria) invasive fungal infection at time of enrollment
boolean
C1262313 (UMLS CUI)
10062642 (MDR)
ExclusionCriterion_2
Item
Patients with pathological functional renal or hepatic parameters
boolean
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
Patients with clinical or laboratory chemical evidence of active veno-occlusive disease (VOD)
boolean
C0948441 (UMLS CUI)
10062173 (MDR)
ExclusionCriterion_4
Item
Hemodynamically unstable patients with a life expectancy of less than 5 days
boolean
C0948268 (UMLS CUI)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
C0023671 (UMLS CUI)
MTHU021387 (LNC)
ExclusionCriterion_5
Item
Patients undergoing co-medication with rifampicin, phenytoin, carbamazepine, phenobarbital, dexamethasone, efavirenz and nevirapine
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
Patients with prior known serious reaction to echinocandin-antifungal formulation or documented allergy to amphotericin B
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
Patients with other condition or illness which, in the estimation of the investigator, distorts the study results or leads to an additional risk for the patient
boolean
CL102947 (UMLS CUI)
ExclusionCriterion_8
Item
Prior inclusion in the study
boolean
C1516879 (UMLS CUI)
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Gender
Item
Gender
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
Healthy Subject
Item
Healthy Subject
string
C1708335 (UMLS CUI)
Neutropenia
Item
Neutropenia
string
C0027947 (UMLS CUI)
D70 (ICD10CM)
288.0 (ICD9CM)
10029354 (MDR)
165517008 (SNOMED CT 2010_0731)
Absolute Neutrophil Count
Item
Absolute Neutrophil Count
string
C0948762 (UMLS CUI)
10052033 (MDR)
Low peripheral neutrophil counts (absolute neutrophil count less than 500/microliter)
Item
Low peripheral neutrophil counts (absolute neutrophil count less than 500/microliter)
string
C2674490 (UMLS CUI)
Allogeneic Hematopoietic Stem Cell Transplantation
Item
Allogeneic Hematopoietic Stem Cell Transplantation
string
C2242529 (UMLS CUI)
10067862 (MDR)
Immunosuppressive therapy for transplant
Item
Immunosuppressive therapy for transplant
string
C0521304 (UMLS CUI)
7447008 (SNOMED CT 2010_0731)
Cyclosporine
Item
Cyclosporine
string
C0010592 (UMLS CUI)
MTHU005140 (LNC)
80906007 (SNOMED CT 2010_0731)
Fever
Item
Fever
string
C0015967 (UMLS CUI)
E11102 (CTCAE)
R50.9 (ICD10CM)
780.60 (ICD9CM)
MTHU013518 (LNC)
10037660 (MDR)
386661006 (SNOMED CT 2010_0731)
Continuous fever
Item
Continuous fever
string
C0424767 (UMLS CUI)
271751000 (SNOMED CT 2010_0731)
Intermittent Pyrexia
Item
Intermittent Pyrexia
string
C0277799 (UMLS CUI)
10058698 (MDR)
77957000 (SNOMED CT 2010_0731)
Systemic antibacterial therapy
Item
Systemic antibacterial therapy
string
C0854606 (UMLS CUI)
10042933 (MDR)
Catheterization, Central Venous
Item
Catheterization, Central Venous
string
C0007435 (UMLS CUI)
10053377 (MDR)
Normal renal function
Item
Normal renal function
string
C0232805 (UMLS CUI)
81141003 (SNOMED CT 2010_0731)
Normal liver function
Item
Normal liver function
string
C1848676 (UMLS CUI)
Negative Pregnancy Test
Item
Negative Pregnancy Test
string
C0427780 (UMLS CUI)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
Contraceptive methods
Item
Contraceptive methods
string
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Invasive mycosis
Item
Invasive mycosis
string
C1262313 (UMLS CUI)
10062642 (MDR)
Abnormal renal function
Item
Abnormal renal function
string
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
Liver Dysfunction
Item
Liver Dysfunction
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Venoocclusive disease
Item
Venoocclusive disease
string
C0948441 (UMLS CUI)
10062173 (MDR)
Hemodynamic instability
Item
Hemodynamic instability
string
C0948268 (UMLS CUI)
10052076 (MDR)
422773005 (SNOMED CT 2010_0731)
Life Expectancy
Item
Life Expectancy
string
C0023671 (UMLS CUI)
MTHU021387 (LNC)
Rifampin
Item
Rifampin
string
C0035608 (UMLS CUI)
MTHU008474 (LNC)
387159009 (SNOMED CT 2010_0731)
Phenytoin
Item
Phenytoin
string
C0031507 (UMLS CUI)
MTHU002993 (LNC)
387220006 (SNOMED CT 2010_0731)
Carbamazepine
Item
Carbamazepine
string
C0006949 (UMLS CUI)
MTHU003352 (LNC)
40820003 (SNOMED CT 2010_0731)
Phenobarbital
Item
Phenobarbital
string
C0031412 (UMLS CUI)
MTHU003431 (LNC)
51073002 (SNOMED CT 2010_0731)
Dexamethasone
Item
Dexamethasone
string
C0011777 (UMLS CUI)
MTHU004621 (LNC)
7561000 (SNOMED CT 2010_0731)
Efavirenz
Item
Efavirenz
string
C0674428 (UMLS CUI)
MTHU013845 (LNC)
116078005 (SNOMED CT 2010_0731)
Nevirapine
Item
Nevirapine
string
C0132326 (UMLS CUI)
MTHU013861 (LNC)
108704001 (SNOMED CT 2010_0731)
Investigator
Item
Investigator
string
CL102947 (UMLS CUI)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
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