ID

30245

Description

Unrelated Double Umbilical Cord Blood Units Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT01015742

Link

https://clinicaltrials.gov/show/NCT01015742

Keywords

Versions (1)
  1. 5/24/18 5/24/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 24, 2018

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License

Creative Commons BY 4.0
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Eligibility Leukemia, Myeloid, Acute NCT01015742

English

Eligibility Leukemia, Myeloid, Acute NCT01015742

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
hematologically & histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in remission
Description

Acute lymphoid leukemia in remission | Acute myeloid leukemia in remission | Chronic myeloid leukemia in remission

Data type

boolean

Alias
UMLS CUI [1]
C0153876
UMLS CUI [2]
C0153886
UMLS CUI [3]
C0153888
aged 1 year to 50 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
absence of hla compatible related or other related donor.
Description

Absence Donor Related HLA Compatibility | Absence Donor Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0013018
UMLS CUI [1,3]
C0080103
UMLS CUI [1,4]
C2348930
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0013018
UMLS CUI [2,3]
C0080103
availability of suitable ucb units.
Description

Availability of Umbilical Cord Blood Unit Suitable

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0162371
UMLS CUI [1,3]
C1519795
UMLS CUI [1,4]
C3900053
karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) : 80- 100
Description

Karnofsky Performance Status | Lansky Play-Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1522275
adequate renal function defined as:serum creatinine <1.5 x normal,
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
adequate liver function defined as:total bilirubin <1.5 x normal, or sgot (ast) or sgpt (alt) <3.0 x normal
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
adequate cardiac function defined as: ejection fraction >50% by echocardiogram.
Description

Cardiac function | Cardiac ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2,1]
C0232174
UMLS CUI [2,2]
C0013516
adequate pulmonary function defined as:uncorrected dlco 50% by pulmonary function test.for children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air
Description

Pulmonary function | DLCO uncorrected Pulmonary function test | Children Uncooperative | Resting Dyspnea Absent | Impaired exercise tolerance Absent | Pulse Oximetry on room air

Data type

boolean

Alias
UMLS CUI [1]
C0231921
UMLS CUI [2,1]
C1516251
UMLS CUI [2,2]
C4072785
UMLS CUI [2,3]
C0024119
UMLS CUI [3,1]
C0008059
UMLS CUI [3,2]
C0424350
UMLS CUI [4,1]
C0743330
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0424551
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0034108
UMLS CUI [6,2]
C2709070
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age: < 1year or > 50 year
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with an available 5-6/6 hla-a, -b, -drb1 matched sibling or other related donor
Description

Availability of Sibling HLA-A Match | Availability of Sibling HLA-B Match | Availability of Sibling HLA-DRB1 Match | Availability of Donor Related

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0037047
UMLS CUI [1,3]
C0019728
UMLS CUI [1,4]
C1708943
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C0037047
UMLS CUI [2,3]
C0019737
UMLS CUI [2,4]
C1708943
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C0037047
UMLS CUI [3,3]
C0122040
UMLS CUI [3,4]
C1708943
UMLS CUI [4,1]
C0470187
UMLS CUI [4,2]
C0013018
UMLS CUI [4,3]
C0080103
karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) < 80
Description

Karnofsky Performance Status | Lansky Play-Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C1522275
hiv positive patients.
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
female patients who are pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
life expectancy severely limited by diseases of vital organs other than the disease indication for transplant
Description

Life Expectancy Limited | Disease Organ Vital | Exception Indication Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0178784
UMLS CUI [2,3]
C0442732
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3146298
UMLS CUI [3,3]
C0040732
serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection
Description

Communicable Disease Serious Untreated | Tuberculosis | Mycoses | Virus Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332155
UMLS CUI [2]
C0041296
UMLS CUI [3]
C0026946
UMLS CUI [4]
C0042769
serious psychiatric/ psychological disorders
Description

Mental disorders Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0205404
absence of /inability to provide informed consent
Description

Informed Consent Absent | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
clinical or paraclinical evidence of cns or pns involvement
Description

Central Nervous System Involvement | Peripheral Nervous System Involvement

Data type

boolean

Alias
UMLS CUI [1]
C4050309
UMLS CUI [2,1]
C0206417
UMLS CUI [2,2]
C1314939
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Similar models

Eligibility Leukemia, Myeloid, Acute NCT01015742

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Acute lymphoid leukemia in remission | Acute myeloid leukemia in remission | Chronic myeloid leukemia in remission
Item
hematologically & histologically confirmed acute lymphoblastic or acute and chronic myeloid leukemia in remission
boolean
C0153876 (UMLS CUI [1])
C0153886 (UMLS CUI [2])
C0153888 (UMLS CUI [3])
Age
Item
aged 1 year to 50 years
boolean
C0001779 (UMLS CUI [1])
Absence Donor Related HLA Compatibility | Absence Donor Related
Item
absence of hla compatible related or other related donor.
boolean
C0332197 (UMLS CUI [1,1])
C0013018 (UMLS CUI [1,2])
C0080103 (UMLS CUI [1,3])
C2348930 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0013018 (UMLS CUI [2,2])
C0080103 (UMLS CUI [2,3])
Availability of Umbilical Cord Blood Unit Suitable
Item
availability of suitable ucb units.
boolean
C0470187 (UMLS CUI [1,1])
C0162371 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,3])
C3900053 (UMLS CUI [1,4])
Karnofsky Performance Status | Lansky Play-Performance Status
Item
karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) : 80- 100
boolean
C0206065 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
adequate renal function defined as:serum creatinine <1.5 x normal,
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
adequate liver function defined as:total bilirubin <1.5 x normal, or sgot (ast) or sgpt (alt) <3.0 x normal
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Cardiac function | Cardiac ejection fraction Echocardiography
Item
adequate cardiac function defined as: ejection fraction >50% by echocardiogram.
boolean
C0232164 (UMLS CUI [1])
C0232174 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Pulmonary function | DLCO uncorrected Pulmonary function test | Children Uncooperative | Resting Dyspnea Absent | Impaired exercise tolerance Absent | Pulse Oximetry on room air
Item
adequate pulmonary function defined as:uncorrected dlco 50% by pulmonary function test.for children who are uncooperative, no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry >94% on room air
boolean
C0231921 (UMLS CUI [1])
C1516251 (UMLS CUI [2,1])
C4072785 (UMLS CUI [2,2])
C0024119 (UMLS CUI [2,3])
C0008059 (UMLS CUI [3,1])
C0424350 (UMLS CUI [3,2])
C0743330 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0424551 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0034108 (UMLS CUI [6,1])
C2709070 (UMLS CUI [6,2])
Item Group
C0680251 (UMLS CUI)
Age
Item
age: < 1year or > 50 year
boolean
C0001779 (UMLS CUI [1])
Availability of Sibling HLA-A Match | Availability of Sibling HLA-B Match | Availability of Sibling HLA-DRB1 Match | Availability of Donor Related
Item
patients with an available 5-6/6 hla-a, -b, -drb1 matched sibling or other related donor
boolean
C0470187 (UMLS CUI [1,1])
C0037047 (UMLS CUI [1,2])
C0019728 (UMLS CUI [1,3])
C1708943 (UMLS CUI [1,4])
C0470187 (UMLS CUI [2,1])
C0037047 (UMLS CUI [2,2])
C0019737 (UMLS CUI [2,3])
C1708943 (UMLS CUI [2,4])
C0470187 (UMLS CUI [3,1])
C0037047 (UMLS CUI [3,2])
C0122040 (UMLS CUI [3,3])
C1708943 (UMLS CUI [3,4])
C0470187 (UMLS CUI [4,1])
C0013018 (UMLS CUI [4,2])
C0080103 (UMLS CUI [4,3])
Karnofsky Performance Status | Lansky Play-Performance Status
Item
karnofsky performance score (> 12 yr) or lansky play performance(<12 yr) < 80
boolean
C0206065 (UMLS CUI [1])
C1522275 (UMLS CUI [2])
HIV Seropositivity
Item
hiv positive patients.
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
female patients who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life Expectancy Limited | Disease Organ Vital | Exception Indication Transplantation
Item
life expectancy severely limited by diseases of vital organs other than the disease indication for transplant
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C0178784 (UMLS CUI [2,2])
C0442732 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C3146298 (UMLS CUI [3,2])
C0040732 (UMLS CUI [3,3])
Communicable Disease Serious Untreated | Tuberculosis | Mycoses | Virus Disease
Item
serious concurrent untreated infection e.g. active tuberculosis, mycoses or viral infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C0041296 (UMLS CUI [2])
C0026946 (UMLS CUI [3])
C0042769 (UMLS CUI [4])
Mental disorders Serious
Item
serious psychiatric/ psychological disorders
boolean
C0004936 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Informed Consent Absent | Informed Consent Unable
Item
absence of /inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Central Nervous System Involvement | Peripheral Nervous System Involvement
Item
clinical or paraclinical evidence of cns or pns involvement
boolean
C4050309 (UMLS CUI [1])
C0206417 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
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