ID

13639

Beschrijving

Investigation of the Human Immune Response in Normal Subjects and Patients With Disorders of the Immune System and Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00001582

Link

https://clinicaltrials.gov/show/NCT00001582

Trefwoorden

Versies (1)
  1. 22-02-16 22-02-16 -
Geüploaded op

22 februari 2016

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility T-cell Lymphoma NCT00001582

Engels

Eligibility T-cell Lymphoma NCT00001582

1 Formulieren  
Criteria
Beschrijving

Criteria

patient must meet at least one of these criteria:
Beschrijving

ID.1

Datatype

boolean

have suspected or known disorder of the immune system or malignancy
Beschrijving

disorder of the immune system or malignancy

Datatype

boolean

Alias
UMLS CUI [1]
C0021053
UMLS CUI [2]
C0006826
be a known or potential carrier of genetically determined autoimmune disorder or immunodeficiency disease.
Beschrijving

autoimmune disorder, or immunodeficiency disease

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0021051
specific i disorders may include but are not limited to: x-linked (severe combined immunodeficiency) scid (c gamma deficiency), autosomal recessive scid, x-linked cd40 ligand deficiency, common variable immunodeficiency, ataxia-telangiectasia, wiskott aldrich syndrome, digeorge syndrome and infection with htlv-1
Beschrijving

specific i disorders may include but are not limited to

Datatype

boolean

Alias
UMLS CUI [1]
C1279481
UMLS CUI [2]
C0259743
UMLS CUI [3]
C0398689
UMLS CUI [4]
C0009447
UMLS CUI [5]
C0004135
UMLS CUI [6]
C0043194
UMLS CUI [7]
C0012236
UMLS CUI [8]
C0020094
age of birth and above for patients with suspected or known disorders of the immune system.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patient (or parent/guardian of a minor child) must be able to understand and sign informed consent.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
hematocrit greater than 28%, and platelet count greater than 50,000 necessary for apheresis.
Beschrijving

hematocrit and platelets

Datatype

float

Alias
UMLS CUI [1]
C0518014
UMLS CUI [2]
C0005821
subjects for whom apheresis is desired but whose counts are lower than those above must be evaluated and approved by a department of transfusion medicine consult physician.
Beschrijving

apheresis

Datatype

boolean

Alias
UMLS CUI [1]
C0518014
UMLS CUI [2]
C0005821
weight greater than 25 kg is necessary for apheresis.
Beschrijving

weight

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
overall exclusion criteria:
Beschrijving

ID.10

Datatype

boolean

pregnant or breast feeding women will not be eligible for any aspect of this protocol except phlebotomy
Beschrijving

pregnant or breast feeding, phlebotomy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0190979
children less than 18 years old are not eligible for lymph node or bone marrow biopsy
Beschrijving

Age, lymph node or bone marrow biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0193842
UMLS CUI [3]
C0005954
exclusion criteria for skin/parenteral antigen tests:
Beschrijving

exclusion criteria for skin/parenteral antigen tests

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
any history of severe reaction or allergy to a particular skin test antigen or other ingredients in the formulation (e.g. thimerosal, eggs or avian protein) will exclude a subject from receiving that particular skin test.
Beschrijving

severe reaction or allergy to a particular skin test antigen

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1521826
children under the age of 2 years are not eligible to receive the pneumococcal polyvalent vaccine.
Beschrijving

Age, polyvalent pneumococcal vaccine

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0305065
subjects under the age of 18 years are not eligible to receive the candida or mumps skin test antigens.
Beschrijving

Age, candida or mumps skin test antigens

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0301461
UMLS CUI [3]
C0301459
exclusion criteria for apheresis alone:
Beschrijving

exclusion criteria for apheresis alone:

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
any diagnosed medical condition which may be worsened by the apheresis procedure. specifically the patient should not have any of the following:
Beschrijving

medical condition which may be worsened by the apheresis procedure

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005791
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
1. congestive heart failure
Beschrijving

congestive heart failure

Datatype

boolean

Alias
UMLS CUI [1]
C0018802
2. history of angina
Beschrijving

angina

Datatype

boolean

Alias
UMLS CUI [1]
C0002962
3. severe hypotension (at the discretion of the patient's physician, the apheresis staff and the attending physician from the department of transfusion medicine (dtm) per dtm standard operating policies.)
Beschrijving

hypotension

Datatype

boolean

Alias
UMLS CUI [1]
C0020649
4. poorly controlled hypertension (average baseline blood pressure greater than 160/90)
Beschrijving

hypertension

Datatype

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0005823
5. history of a coagulation protein disorder.
Beschrijving

ID.23

Datatype

boolean

Alias
UMLS CUI [1]
C0600503
pediatric normal volunteers (less than 18 years) will not undergo apheresis.
Beschrijving

pediatric normal volunteers will not undergo apheresis

Datatype

boolean

Alias
UMLS CUI [1]
C3661466
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0005791
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Similar models

Eligibility T-cell Lymphoma NCT00001582

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
ID.1
Item
patient must meet at least one of these criteria:
boolean
disorder of the immune system or malignancy
Item
have suspected or known disorder of the immune system or malignancy
boolean
C0021053 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
autoimmune disorder, or immunodeficiency disease
Item
be a known or potential carrier of genetically determined autoimmune disorder or immunodeficiency disease.
boolean
C0004364 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
specific i disorders may include but are not limited to
Item
specific i disorders may include but are not limited to: x-linked (severe combined immunodeficiency) scid (c gamma deficiency), autosomal recessive scid, x-linked cd40 ligand deficiency, common variable immunodeficiency, ataxia-telangiectasia, wiskott aldrich syndrome, digeorge syndrome and infection with htlv-1
boolean
C1279481 (UMLS CUI [1])
C0259743 (UMLS CUI [2])
C0398689 (UMLS CUI [3])
C0009447 (UMLS CUI [4])
C0004135 (UMLS CUI [5])
C0043194 (UMLS CUI [6])
C0012236 (UMLS CUI [7])
C0020094 (UMLS CUI [8])
Age
Item
age of birth and above for patients with suspected or known disorders of the immune system.
boolean
C0001779 (UMLS CUI [1])
informed consent
Item
patient (or parent/guardian of a minor child) must be able to understand and sign informed consent.
boolean
C0021430 (UMLS CUI [1])
hematocrit and platelets
Item
hematocrit greater than 28%, and platelet count greater than 50,000 necessary for apheresis.
float
C0518014 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
apheresis
Item
subjects for whom apheresis is desired but whose counts are lower than those above must be evaluated and approved by a department of transfusion medicine consult physician.
boolean
C0518014 (UMLS CUI [1])
C0005821 (UMLS CUI [2])
weight
Item
weight greater than 25 kg is necessary for apheresis.
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ID.10
Item
overall exclusion criteria:
boolean
pregnant or breast feeding, phlebotomy
Item
pregnant or breast feeding women will not be eligible for any aspect of this protocol except phlebotomy
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0190979 (UMLS CUI [3])
Age, lymph node or bone marrow biopsy
Item
children less than 18 years old are not eligible for lymph node or bone marrow biopsy
boolean
C0001779 (UMLS CUI [1])
C0193842 (UMLS CUI [2])
C0005954 (UMLS CUI [3])
exclusion criteria for skin/parenteral antigen tests
Item
exclusion criteria for skin/parenteral antigen tests:
boolean
C0680251 (UMLS CUI [1])
severe reaction or allergy to a particular skin test antigen
Item
any history of severe reaction or allergy to a particular skin test antigen or other ingredients in the formulation (e.g. thimerosal, eggs or avian protein) will exclude a subject from receiving that particular skin test.
boolean
C0020517 (UMLS CUI [1,1])
C1521826 (UMLS CUI [1,2])
Age, polyvalent pneumococcal vaccine
Item
children under the age of 2 years are not eligible to receive the pneumococcal polyvalent vaccine.
boolean
C0001779 (UMLS CUI [1])
C0305065 (UMLS CUI [2])
Age, candida or mumps skin test antigens
Item
subjects under the age of 18 years are not eligible to receive the candida or mumps skin test antigens.
boolean
C0001779 (UMLS CUI [1])
C0301461 (UMLS CUI [2])
C0301459 (UMLS CUI [3])
exclusion criteria for apheresis alone:
Item
exclusion criteria for apheresis alone:
boolean
C0680251 (UMLS CUI [1])
medical condition which may be worsened by the apheresis procedure
Item
any diagnosed medical condition which may be worsened by the apheresis procedure. specifically the patient should not have any of the following:
boolean
C0005791 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
congestive heart failure
Item
1. congestive heart failure
boolean
C0018802 (UMLS CUI [1])
angina
Item
2. history of angina
boolean
C0002962 (UMLS CUI [1])
hypotension
Item
3. severe hypotension (at the discretion of the patient's physician, the apheresis staff and the attending physician from the department of transfusion medicine (dtm) per dtm standard operating policies.)
boolean
C0020649 (UMLS CUI [1])
hypertension
Item
4. poorly controlled hypertension (average baseline blood pressure greater than 160/90)
boolean
C0020538 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
ID.23
Item
5. history of a coagulation protein disorder.
boolean
C0600503 (UMLS CUI [1])
pediatric normal volunteers will not undergo apheresis
Item
pediatric normal volunteers (less than 18 years) will not undergo apheresis.
boolean
C3661466 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0005791 (UMLS CUI [3])
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