ID

30183

Beskrivning

Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00844441

Länk

https://clinicaltrials.gov/show/NCT00844441

Nyckelord

Versioner (1)
  1. 2018-05-18 2018-05-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Leukemia NCT00844441

Engelsk

Eligibility Leukemia NCT00844441

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00844441
Criteria
Beskrivning

Criteria

diagnosis of one of the following:
Beskrivning

Diagnosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0011900
myelodysplastic syndromes
Beskrivning

Myelodysplastic syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C3463824
acute myeloid leukemia (aml)
Beskrivning

Leukemia, Myelocytic, Acute

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
no acute promyelocytic leukemia with t(15;17)(q22;q12), pml/rar, or other variants
Beskrivning

Exclusion Acute Promyelocytic Leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2828389
UMLS CUI [1,2]
C0023487
planning to undergo aml-like intensive induction chemotherapy (e.g., "7+3" or regimen with similar or higher intensity) for untreated or relapsed disease within 1 week after study entry or has started therapy within the past 72 hours
Beskrivning

Induction Chemotherapy With intensity Planned | Disease untreated | Recurrent disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3179010
UMLS CUI [1,2]
C0522510
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0277556
patient characteristics:
Beskrivning

Client Characteristics

Datatyp

boolean

Alias
UMLS CUI [1]
C0815172
no hypersensitivity or allergy to fluoroquinolones, triazoles, or acyclovir
Beskrivning

Absence Hypersensitivity Fluoroquinolones | Absence Hypersensitivity Triazoles | Absence Aciclovir allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0020517
UMLS CUI [1,3]
C0949665
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0020517
UMLS CUI [2,3]
C0040880
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C0571297
ecog/who/zubrod performance status 0-1*
Beskrivning

ECOG performance status | WHO performance status scale | Zubrod Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C1298650
UMLS CUI [3]
C3714786
total bilirubin ≤ 2.5 times upper limit of normal (uln) (unless elevation is thought to be due to gilbert's syndrome or hemolysis)*
Beskrivning

Serum total bilirubin measurement | Exception Etiology Gilbert Disease | Exception Etiology Hemolysis

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0017551
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0015127
UMLS CUI [3,3]
C0019054
ast and alt ≤ 1.5 times uln*
Beskrivning

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine ≤ 1.5 times uln*
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
no clinical evidence of congestive heart failure*
Beskrivning

Congestive heart failure Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0332197
no active bleeding*
Beskrivning

Hemorrhage Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0332197
not refractory to platelet transfusions (e.g., due to hla-alloimmunization)*
Beskrivning

Absence Unresponsive to Platelet Transfusion | Etiology HLA Alloimmunisation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0086818
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0019721
UMLS CUI [2,3]
C0948201
no requirement for iv antimicrobial therapy*
Beskrivning

Absence Requirement Microbicides Intravenous

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1136254
UMLS CUI [1,4]
C1522726
agrees to undergo close follow-up that includes ≥ 3 visits per week at the seattle cancer care alliance (scca)*
Beskrivning

Compliance behavior Follow-up | Visit Quantity per week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [2,1]
C0589121
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0332174
has a confirmed reliable caregiver and transportation*
Beskrivning

Caregiver Available | Transportation Available

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085537
UMLS CUI [1,2]
C0470187
UMLS CUI [2,1]
C2239248
UMLS CUI [2,2]
C0470187
confirmed temporary or permanent residency within a 30-minute commute from the university of washington (uw) medical center/scca*
Beskrivning

Residence Nearby Medical center

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0237096
UMLS CUI [1,2]
C1706276
UMLS CUI [1,3]
C0565990
has identified a uw/scca hematologist/oncologist who is willing to care for the patient in the outpatient clinic* note: *additional criteria for early discharge from the hospital
Beskrivning

Availability of Hematologist Patient care | Availability of Oncologist Patient care

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0278598
UMLS CUI [1,3]
C0017313
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0259990
UMLS CUI [2,3]
C0017313
prior concurrent therapy:
Beskrivning

Therapeutic procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Beskrivning

ID.21

Datatyp

boolean

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Similar models

Eligibility Leukemia NCT00844441

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Leukemia NCT00844441
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Diagnosis
Item
diagnosis of one of the following:
boolean
C0011900 (UMLS CUI [1])
Myelodysplastic syndrome
Item
myelodysplastic syndromes
boolean
C3463824 (UMLS CUI [1])
Leukemia, Myelocytic, Acute
Item
acute myeloid leukemia (aml)
boolean
C0023467 (UMLS CUI [1])
Exclusion Acute Promyelocytic Leukemia
Item
no acute promyelocytic leukemia with t(15;17)(q22;q12), pml/rar, or other variants
boolean
C2828389 (UMLS CUI [1,1])
C0023487 (UMLS CUI [1,2])
Induction Chemotherapy With intensity Planned | Disease untreated | Recurrent disease
Item
planning to undergo aml-like intensive induction chemotherapy (e.g., "7+3" or regimen with similar or higher intensity) for untreated or relapsed disease within 1 week after study entry or has started therapy within the past 72 hours
boolean
C3179010 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Absence Hypersensitivity Fluoroquinolones | Absence Hypersensitivity Triazoles | Absence Aciclovir allergy
Item
no hypersensitivity or allergy to fluoroquinolones, triazoles, or acyclovir
boolean
C0332197 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0949665 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
C0040880 (UMLS CUI [2,3])
C0332197 (UMLS CUI [3,1])
C0571297 (UMLS CUI [3,2])
ECOG performance status | WHO performance status scale | Zubrod Performance Status
Item
ecog/who/zubrod performance status 0-1*
boolean
C1520224 (UMLS CUI [1])
C1298650 (UMLS CUI [2])
C3714786 (UMLS CUI [3])
Serum total bilirubin measurement | Exception Etiology Gilbert Disease | Exception Etiology Hemolysis
Item
total bilirubin ≤ 2.5 times upper limit of normal (uln) (unless elevation is thought to be due to gilbert's syndrome or hemolysis)*
boolean
C1278039 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0017551 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0019054 (UMLS CUI [3,3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt ≤ 1.5 times uln*
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 times uln*
boolean
C0201976 (UMLS CUI [1])
Congestive heart failure Absent
Item
no clinical evidence of congestive heart failure*
boolean
C0018802 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Hemorrhage Absent
Item
no active bleeding*
boolean
C0019080 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Absence Unresponsive to Platelet Transfusion | Etiology HLA Alloimmunisation
Item
not refractory to platelet transfusions (e.g., due to hla-alloimmunization)*
boolean
C0332197 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0086818 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0019721 (UMLS CUI [2,2])
C0948201 (UMLS CUI [2,3])
Absence Requirement Microbicides Intravenous
Item
no requirement for iv antimicrobial therapy*
boolean
C0332197 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1136254 (UMLS CUI [1,3])
C1522726 (UMLS CUI [1,4])
Compliance behavior Follow-up | Visit Quantity per week
Item
agrees to undergo close follow-up that includes ≥ 3 visits per week at the seattle cancer care alliance (scca)*
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0589121 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0332174 (UMLS CUI [2,3])
Caregiver Available | Transportation Available
Item
has a confirmed reliable caregiver and transportation*
boolean
C0085537 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C2239248 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
Residence Nearby Medical center
Item
confirmed temporary or permanent residency within a 30-minute commute from the university of washington (uw) medical center/scca*
boolean
C0237096 (UMLS CUI [1,1])
C1706276 (UMLS CUI [1,2])
C0565990 (UMLS CUI [1,3])
Availability of Hematologist Patient care | Availability of Oncologist Patient care
Item
has identified a uw/scca hematologist/oncologist who is willing to care for the patient in the outpatient clinic* note: *additional criteria for early discharge from the hospital
boolean
C0470187 (UMLS CUI [1,1])
C0278598 (UMLS CUI [1,2])
C0017313 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C0259990 (UMLS CUI [2,2])
C0017313 (UMLS CUI [2,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.21
Item
see disease characteristics
boolean
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