ID

39511

Beschrijving

Prospective Observation of Cardiac Safety With Proteasome Inhibition; ODM derived from: https://clinicaltrials.gov/show/NCT02178579

Link

https://clinicaltrials.gov/show/NCT02178579

Trefwoorden

Versies (1)
  1. 21-01-20 21-01-20 -
Houder van rechten

See clinicaltrials.gov

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21 januari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02178579

Engels

Eligibility Heart Failure NCT02178579

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsed multiple myeloma at any time-point in treatment course and planning to start a proteasome inhibitor-based therapy as part of standard care
Beschrijving

Recurrent Multiple Myeloma | Proteasome inhibitor Planned | Part of Standard therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1370446
UMLS CUI [2,1]
C1443643
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C1292711
UMLS CUI [3,2]
C2936643
received at least one prior line of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy)
Beschrijving

Treatment Course Quantity Multiple Myeloma | Neoadjuvant Therapy | Stem cell transplant | Consolidation therapy | Maintenance therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C0026764
UMLS CUI [2]
C0600558
UMLS CUI [3]
C1504389
UMLS CUI [4]
C1511484
UMLS CUI [5]
C0677908
males and females ≥ 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
able to provide written informed consent in accordance with federal, local, and institutional guidelines
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Beschrijving

POEMS Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0085404
known or suspected al amyloidosis, secondary amyloidosis or cardiac amyloidosis
Beschrijving

Primary amyloidosis | Primary amyloidosis Suspected | Reactive systemic amyloidosis | Reactive systemic amyloidosis Suspected | Cardiac amyloidosis | Cardiac amyloidosis Suspected

Datatype

boolean

Alias
UMLS CUI [1]
C0268381
UMLS CUI [2,1]
C0268381
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0221014
UMLS CUI [4,1]
C0221014
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0268407
UMLS CUI [6,1]
C0268407
UMLS CUI [6,2]
C0750491
plasma cell leukemia (> 2.0 × 109/l circulating plasma cells by standard differential)
Beschrijving

Leukemia, Plasma Cell | Circulating Plasma Cell Measurement Differential quality

Datatype

boolean

Alias
UMLS CUI [1]
C0023484
UMLS CUI [2,1]
C3811668
UMLS CUI [2,2]
C0242485
UMLS CUI [2,3]
C0443199
waldenström macroglobulinemia
Beschrijving

Waldenstrom Macroglobulinemia

Datatype

boolean

Alias
UMLS CUI [1]
C0024419
myelodysplastic syndrome
Beschrijving

MYELODYSPLASTIC SYNDROME

Datatype

boolean

Alias
UMLS CUI [1]
C3463824
history of mi within the last 3 months
Beschrijving

Myocardial Infarction

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
symptomatic unstable cardiac arrhythmia requiring treatment in the past 3 months
Beschrijving

Cardiac Arrhythmia Symptomatic Unstable | Treatment required

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0443343
UMLS CUI [2]
C0332121
class 3 or 4 new york heart association heart failure in the past 3 months
Beschrijving

Heart failure New York Heart Association Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
Beschrijving

Disease Interferes with Protocol Compliance | Medical condition Interferes with Protocol Compliance | Disease Interferes with Informed Consent | Medical condition Interferes with Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0021430
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Similar models

Eligibility Heart Failure NCT02178579

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Recurrent Multiple Myeloma | Proteasome inhibitor Planned | Part of Standard therapy
Item
relapsed multiple myeloma at any time-point in treatment course and planning to start a proteasome inhibitor-based therapy as part of standard care
boolean
C1370446 (UMLS CUI [1])
C1443643 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C1292711 (UMLS CUI [3,1])
C2936643 (UMLS CUI [3,2])
Treatment Course Quantity Multiple Myeloma | Neoadjuvant Therapy | Stem cell transplant | Consolidation therapy | Maintenance therapy
Item
received at least one prior line of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy)
boolean
C0087111 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0026764 (UMLS CUI [1,4])
C0600558 (UMLS CUI [2])
C1504389 (UMLS CUI [3])
C1511484 (UMLS CUI [4])
C0677908 (UMLS CUI [5])
Age
Item
males and females ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
able to provide written informed consent in accordance with federal, local, and institutional guidelines
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
POEMS Syndrome
Item
poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
boolean
C0085404 (UMLS CUI [1])
Primary amyloidosis | Primary amyloidosis Suspected | Reactive systemic amyloidosis | Reactive systemic amyloidosis Suspected | Cardiac amyloidosis | Cardiac amyloidosis Suspected
Item
known or suspected al amyloidosis, secondary amyloidosis or cardiac amyloidosis
boolean
C0268381 (UMLS CUI [1])
C0268381 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0221014 (UMLS CUI [3])
C0221014 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0268407 (UMLS CUI [5])
C0268407 (UMLS CUI [6,1])
C0750491 (UMLS CUI [6,2])
Leukemia, Plasma Cell | Circulating Plasma Cell Measurement Differential quality
Item
plasma cell leukemia (> 2.0 × 109/l circulating plasma cells by standard differential)
boolean
C0023484 (UMLS CUI [1])
C3811668 (UMLS CUI [2,1])
C0242485 (UMLS CUI [2,2])
C0443199 (UMLS CUI [2,3])
Waldenstrom Macroglobulinemia
Item
waldenström macroglobulinemia
boolean
C0024419 (UMLS CUI [1])
MYELODYSPLASTIC SYNDROME
Item
myelodysplastic syndrome
boolean
C3463824 (UMLS CUI [1])
Myocardial Infarction
Item
history of mi within the last 3 months
boolean
C0027051 (UMLS CUI [1])
Cardiac Arrhythmia Symptomatic Unstable | Treatment required
Item
symptomatic unstable cardiac arrhythmia requiring treatment in the past 3 months
boolean
C0003811 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C0332121 (UMLS CUI [2])
Heart failure New York Heart Association Classification
Item
class 3 or 4 new york heart association heart failure in the past 3 months
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Disease Interferes with Protocol Compliance | Medical condition Interferes with Protocol Compliance | Disease Interferes with Informed Consent | Medical condition Interferes with Informed Consent
Item
any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])
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