English

Eligibility Myelodysplastic Syndromes NCT00915811

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient selection
Description

Patient Selection

Data type

boolean

Alias
UMLS CUI [1]
C0242802
1. availability of a hla compatible sibling donor
Description

Availability of HLA Match Sibling Donor

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C4330149
UMLS CUI [1,3]
C0037047
UMLS CUI [1,4]
C0013018
2. age >18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. myelodysplastic syndromes with ipss intermediate-2 or high.
Description

MYELODYSPLASTIC SYNDROME IPSS

Data type

boolean

Alias
UMLS CUI [1,1]
C3463824
UMLS CUI [1,2]
C2827405
4. poor risk acute myeloid leukaemia, de novo or transformed from mds
Description

Risk Poor AML | AML de novo | MYELODYSPLASTIC SYNDROME transformed AML

Data type

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C0023467
UMLS CUI [2,1]
C0023467
UMLS CUI [2,2]
C1515568
UMLS CUI [3,1]
C3463824
UMLS CUI [3,2]
C1510411
UMLS CUI [3,3]
C0023467
5. ineligibility for standard conditioning allograft due to age or co-existing morbidities
Description

Ineligibility Allograft | Age | Comorbidity

Data type

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C0040739
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0009488
donor selection
Description

Donor Selection

Data type

boolean

Alias
UMLS CUI [1]
C1449559
1. related donors compatible for hla-a, b, c, drb1 and dqb1 by molecular typing.
Description

Matched Related Donor HLA-A Molecular Typing | Matched Related Donor HLA-B Molecular Typing | Matched Related Donor HLA-C Molecular Typing | Matched Related Donor HLA-DRB1 Molecular Typing | Matched Related Donor HLA-DQB1 Molecular Typing

Data type

boolean

Alias
UMLS CUI [1,1]
C4330663
UMLS CUI [1,2]
C0019728
UMLS CUI [1,3]
C2936546
UMLS CUI [2,1]
C4330663
UMLS CUI [2,2]
C0019737
UMLS CUI [2,3]
C2936546
UMLS CUI [3,1]
C4330663
UMLS CUI [3,2]
C0019751
UMLS CUI [3,3]
C2936546
UMLS CUI [4,1]
C4330663
UMLS CUI [4,2]
C0122040
UMLS CUI [4,3]
C2936546
UMLS CUI [5,1]
C4330663
UMLS CUI [5,2]
C0122020
UMLS CUI [5,3]
C2936546
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient selection
Description

Patient Selection

Data type

boolean

Alias
UMLS CUI [1]
C0242802
1. cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
Description

Heart failure Treatment required for | Coronary Artery Disease Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0231220
2. hepatic disease, with ast > 2 times normal.
Description

Liver disease | Aspartate aminotransferase increased

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
3. severe hypoxaemia, po2 < 70 mm hg, with decreased dlco < 70% of predicted; or mild hypoxemia, po2 < 80 mm hg with severely decreased dlco < 60% of predicted.
Description

Hypoxemia Severe | PO2 measurement | Decreased DLCO | Hypoxemia Mild | Decreased DLCO Severely

Data type

boolean

Alias
UMLS CUI [1,1]
C0700292
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1283004
UMLS CUI [3]
C4073175
UMLS CUI [4,1]
C0700292
UMLS CUI [4,2]
C2945599
UMLS CUI [5,1]
C4073175
UMLS CUI [5,2]
C0205082
4. impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
Description

Renal Insufficiency | Serum creatinine raised | Creatinine clearance measurement | Age | Gender | Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
UMLS CUI [3]
C0373595
UMLS CUI [4]
C0001779
UMLS CUI [5]
C0079399
UMLS CUI [6]
C0005910
5. patients who have received previous treatment with thymoglobuline
Description

Thymoglobulin

Data type

boolean

Alias
UMLS CUI [1]
C0730920
6. hiv-positive patients.
Description

HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0019699
7. female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. life expectancy severely limited by diseases other than mds or mpd.
Description

Life Expectancy Limitation Severe | Etiology Disease | Exception MYELODYSPLASTIC SYNDROME | Exception Myeloproliferative disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0449295
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0012634
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3463824
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0027022
9. serious concurrent untreated infection
Description

Communicable Disease Serious Untreated

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332155
10. patients with limited life expectancy for other reasons
Description

Life Expectancy Limited Other reasons

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C3845511
11. serious psychiatric/ psychological disorders
Description

Serious mental illness

Data type

boolean

Alias
UMLS CUI [1]
C3841614
12. 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
donor selection
Description

Donor Selection

Data type

boolean

Alias
UMLS CUI [1]
C1449559
1. age >75 years, unless independently assessed to be medically fit to donate
Description

Age | Exception Fit Tissue Donation

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0424576
UMLS CUI [2,3]
C0080231
2. donors who for any reason are unable to tolerate the leukapheresis procedure and cannot undergo anaesthesia for marrow harvest.
Description

Donor Leukapheresis Unable | Donor Anesthesia Unable | Anesthesia Bone marrow harvest

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0023416
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C0002903
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0002903
UMLS CUI [3,2]
C0194015
3. donors who are hiv-positive, or hepatitis b or c pcr positive.
Description

Donor HIV Seropositivity | Donor Blood hepatitis B virus detection by polymerase chain reaction test | Donor Serum hepatitis C detection by polymerase chain reaction test

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C0019699
UMLS CUI [2,1]
C0013018
UMLS CUI [2,2]
C2120948
UMLS CUI [3,1]
C0013018
UMLS CUI [3,2]
C2098826
4. donors who are medically unsuitable to donate
Description

Donor Medically unfit Tissue Donation

Data type

boolean

Alias
UMLS CUI [1,1]
C0013018
UMLS CUI [1,2]
C3841806
UMLS CUI [1,3]
C0080231
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Similar models

Eligibility Myelodysplastic Syndromes NCT00915811

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Patient Selection
Item
patient selection
boolean
C0242802 (UMLS CUI [1])
Availability of HLA Match Sibling Donor
Item
1. availability of a hla compatible sibling donor
boolean
C0470187 (UMLS CUI [1,1])
C4330149 (UMLS CUI [1,2])
C0037047 (UMLS CUI [1,3])
C0013018 (UMLS CUI [1,4])
Age
Item
2. age >18 years
boolean
C0001779 (UMLS CUI [1])
MYELODYSPLASTIC SYNDROME IPSS
Item
3. myelodysplastic syndromes with ipss intermediate-2 or high.
boolean
C3463824 (UMLS CUI [1,1])
C2827405 (UMLS CUI [1,2])
Risk Poor AML | AML de novo | MYELODYSPLASTIC SYNDROME transformed AML
Item
4. poor risk acute myeloid leukaemia, de novo or transformed from mds
boolean
C0035647 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
C0023467 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C3463824 (UMLS CUI [3,1])
C1510411 (UMLS CUI [3,2])
C0023467 (UMLS CUI [3,3])
Ineligibility Allograft | Age | Comorbidity
Item
5. ineligibility for standard conditioning allograft due to age or co-existing morbidities
boolean
C1512714 (UMLS CUI [1,1])
C0040739 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0009488 (UMLS CUI [3])
Donor Selection
Item
donor selection
boolean
C1449559 (UMLS CUI [1])
Matched Related Donor HLA-A Molecular Typing | Matched Related Donor HLA-B Molecular Typing | Matched Related Donor HLA-C Molecular Typing | Matched Related Donor HLA-DRB1 Molecular Typing | Matched Related Donor HLA-DQB1 Molecular Typing
Item
1. related donors compatible for hla-a, b, c, drb1 and dqb1 by molecular typing.
boolean
C4330663 (UMLS CUI [1,1])
C0019728 (UMLS CUI [1,2])
C2936546 (UMLS CUI [1,3])
C4330663 (UMLS CUI [2,1])
C0019737 (UMLS CUI [2,2])
C2936546 (UMLS CUI [2,3])
C4330663 (UMLS CUI [3,1])
C0019751 (UMLS CUI [3,2])
C2936546 (UMLS CUI [3,3])
C4330663 (UMLS CUI [4,1])
C0122040 (UMLS CUI [4,2])
C2936546 (UMLS CUI [4,3])
C4330663 (UMLS CUI [5,1])
C0122020 (UMLS CUI [5,2])
C2936546 (UMLS CUI [5,3])
Item Group
C0680251 (UMLS CUI)
Patient Selection
Item
patient selection
boolean
C0242802 (UMLS CUI [1])
Heart failure Treatment required for | Coronary Artery Disease Symptomatic
Item
1. cardiac insufficiency requiring treatment or symptomatic coronary artery disease.
boolean
C0018801 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Liver disease | Aspartate aminotransferase increased
Item
2. hepatic disease, with ast > 2 times normal.
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Hypoxemia Severe | PO2 measurement | Decreased DLCO | Hypoxemia Mild | Decreased DLCO Severely
Item
3. severe hypoxaemia, po2 < 70 mm hg, with decreased dlco < 70% of predicted; or mild hypoxemia, po2 < 80 mm hg with severely decreased dlco < 60% of predicted.
boolean
C0700292 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1283004 (UMLS CUI [2])
C4073175 (UMLS CUI [3])
C0700292 (UMLS CUI [4,1])
C2945599 (UMLS CUI [4,2])
C4073175 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Renal Insufficiency | Serum creatinine raised | Creatinine clearance measurement | Age | Gender | Body Weight
Item
4. impaired renal function (creatinine > 2 times upper limit of normal or creatinine clearance < 50% for age, gender, weight).
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C0005910 (UMLS CUI [6])
Thymoglobulin
Item
5. patients who have received previous treatment with thymoglobuline
boolean
C0730920 (UMLS CUI [1])
HIV Seropositivity
Item
6. hiv-positive patients.
boolean
C0019699 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
7. female patients who are pregnant or breast feeding due to risks to foetus from conditioning regimen and potential risks to nursing infants.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Life Expectancy Limitation Severe | Etiology Disease | Exception MYELODYSPLASTIC SYNDROME | Exception Myeloproliferative disease
Item
8. life expectancy severely limited by diseases other than mds or mpd.
boolean
C0023671 (UMLS CUI [1,1])
C0449295 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3463824 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0027022 (UMLS CUI [4,2])
Communicable Disease Serious Untreated
Item
9. serious concurrent untreated infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
Life Expectancy Limited Other reasons
Item
10. patients with limited life expectancy for other reasons
boolean
C0023671 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C3845511 (UMLS CUI [1,3])
Serious mental illness
Item
11. serious psychiatric/ psychological disorders
boolean
C3841614 (UMLS CUI [1])
Informed Consent Absent | Informed Consent Unable
Item
12. 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])
Donor Selection
Item
donor selection
boolean
C1449559 (UMLS CUI [1])
Age | Exception Fit Tissue Donation
Item
1. age >75 years, unless independently assessed to be medically fit to donate
boolean
C0001779 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0424576 (UMLS CUI [2,2])
C0080231 (UMLS CUI [2,3])
Donor Leukapheresis Unable | Donor Anesthesia Unable | Anesthesia Bone marrow harvest
Item
2. donors who for any reason are unable to tolerate the leukapheresis procedure and cannot undergo anaesthesia for marrow harvest.
boolean
C0013018 (UMLS CUI [1,1])
C0023416 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0013018 (UMLS CUI [2,1])
C0002903 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0002903 (UMLS CUI [3,1])
C0194015 (UMLS CUI [3,2])
Donor HIV Seropositivity | Donor Blood hepatitis B virus detection by polymerase chain reaction test | Donor Serum hepatitis C detection by polymerase chain reaction test
Item
3. donors who are hiv-positive, or hepatitis b or c pcr positive.
boolean
C0013018 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
C0013018 (UMLS CUI [2,1])
C2120948 (UMLS CUI [2,2])
C0013018 (UMLS CUI [3,1])
C2098826 (UMLS CUI [3,2])
Donor Medically unfit Tissue Donation
Item
4. donors who are medically unsuitable to donate
boolean
C0013018 (UMLS CUI [1,1])
C3841806 (UMLS CUI [1,2])
C0080231 (UMLS CUI [1,3])
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