ID

37812

Beschrijving

Lactobacillus in Preventing Infection in Patients Undergoing a Donor Stem Cell Transplant for Hematologic Cancer or Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00946283

Link

https://clinicaltrials.gov/show/NCT00946283

Trefwoorden

Versies (1)
  1. 25-08-19 25-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

25 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00946283

Engels

Eligibility Breast Cancer NCT00946283

1 Formulieren  
Criteria
Beschrijving

Criteria

currently undergoing allogeneic stem cell transplantation from a related or unrelated donor for a hematologic malignancy or myelodysplastic syndrome
Beschrijving

Allogeneic Stem Cell Transplantation Hematologic Neoplasm | Allogeneic Stem Cell Transplantation MYELODYSPLASTIC SYNDROME | Donor Biological Relative | Donor Unrelated

Datatype

boolean

Alias
UMLS CUI [1,1]
C2242529
UMLS CUI [1,2]
C0376545
UMLS CUI [2,1]
C2242529
UMLS CUI [2,2]
C3463824
UMLS CUI [3,1]
C0040288
UMLS CUI [3,2]
C1266852
UMLS CUI [4,1]
C0040288
UMLS CUI [4,2]
C0445356
hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count > 1000/μl for > 3 days without filgrastim (g-csf) support within 30 days of transplant
Beschrijving

Engraftment Hematopoietic | Recovery Absolute neutrophil count | Filgrastim Support Absent | G-CSF Support Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0301944
UMLS CUI [1,2]
C0229601
UMLS CUI [2,1]
C2004454
UMLS CUI [2,2]
C0948762
UMLS CUI [3,1]
C0210630
UMLS CUI [3,2]
C1521721
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0079459
UMLS CUI [4,2]
C1521721
UMLS CUI [4,3]
C0332197
patient characteristics:
Beschrijving

Client Characteristics

Datatype

boolean

Alias
UMLS CUI [1]
C0815172
ecog performance status 0-2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
serum creatinine ≤ 2.0
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
ast or alt ≤ 3 times upper limit of normal (uln)
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
total bilirubin ≤ 2.0 times uln
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
no clostridium difficile enterocolitis diagnosed during the transplant hospitalization in the peri-transplant period
Beschrijving

Clostridium Enterocolitis Absent | Hospitalization Transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C1257844
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0040732
able to take medications by mouth
Beschrijving

Able to swallow Oral medication

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
no evidence of graft-vs-host disease
Beschrijving

Graft-vs-Host Disease Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018133
UMLS CUI [1,2]
C0332197
no history of inflammatory bowel disease or other chronic diarrheal illness
Beschrijving

Inflammatory Bowel Disease Absent | Chronic diarrhea Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021390
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0401151
UMLS CUI [2,2]
C0332197
no history of hypersensitivity to milk proteins
Beschrijving

Milk protein allergy Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C3889086
UMLS CUI [1,2]
C0332197
prior concurrent therapy:
Beschrijving

Prior Therapy

Datatype

boolean

Alias
UMLS CUI [1]
C1514463
see disease characteristics
Beschrijving

ID.14

Datatype

boolean

more than 3 months since prior use of probiotics supplements, excluding yogurt and cheeses with live cultures
Beschrijving

Synbiotic Supplement Previous | Exception Yogurt | Exception Cheese

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274627
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0043419
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007968
no concurrent over-the-counter medications or herbal remedies
Beschrijving

Non-Prescription Drugs Absent | Herbal medicine Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C2240391
UMLS CUI [2,2]
C0332197
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Similar models

Eligibility Breast Cancer NCT00946283

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Allogeneic Stem Cell Transplantation Hematologic Neoplasm | Allogeneic Stem Cell Transplantation MYELODYSPLASTIC SYNDROME | Donor Biological Relative | Donor Unrelated
Item
currently undergoing allogeneic stem cell transplantation from a related or unrelated donor for a hematologic malignancy or myelodysplastic syndrome
boolean
C2242529 (UMLS CUI [1,1])
C0376545 (UMLS CUI [1,2])
C2242529 (UMLS CUI [2,1])
C3463824 (UMLS CUI [2,2])
C0040288 (UMLS CUI [3,1])
C1266852 (UMLS CUI [3,2])
C0040288 (UMLS CUI [4,1])
C0445356 (UMLS CUI [4,2])
Engraftment Hematopoietic | Recovery Absolute neutrophil count | Filgrastim Support Absent | G-CSF Support Absent
Item
hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count > 1000/μl for > 3 days without filgrastim (g-csf) support within 30 days of transplant
boolean
C0301944 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
C2004454 (UMLS CUI [2,1])
C0948762 (UMLS CUI [2,2])
C0210630 (UMLS CUI [3,1])
C1521721 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0079459 (UMLS CUI [4,1])
C1521721 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤ 2.0
boolean
C0201976 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast or alt ≤ 3 times upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin ≤ 2.0 times uln
boolean
C1278039 (UMLS CUI [1])
Clostridium Enterocolitis Absent | Hospitalization Transplantation
Item
no clostridium difficile enterocolitis diagnosed during the transplant hospitalization in the peri-transplant period
boolean
C1257844 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
Able to swallow Oral medication
Item
able to take medications by mouth
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Graft-vs-Host Disease Absent
Item
no evidence of graft-vs-host disease
boolean
C0018133 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Inflammatory Bowel Disease Absent | Chronic diarrhea Absent
Item
no history of inflammatory bowel disease or other chronic diarrheal illness
boolean
C0021390 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0401151 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Milk protein allergy Absent
Item
no history of hypersensitivity to milk proteins
boolean
C3889086 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Prior Therapy
Item
prior concurrent therapy:
boolean
C1514463 (UMLS CUI [1])
ID.14
Item
see disease characteristics
boolean
Synbiotic Supplement Previous | Exception Yogurt | Exception Cheese
Item
more than 3 months since prior use of probiotics supplements, excluding yogurt and cheeses with live cultures
boolean
C3274627 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0043419 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007968 (UMLS CUI [3,2])
Non-Prescription Drugs Absent | Herbal medicine Absent
Item
no concurrent over-the-counter medications or herbal remedies
boolean
C0013231 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2240391 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
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