ID

36377

Description

ImmuniCell® in Patients With Advanced Cancers; ODM derived from: https://clinicaltrials.gov/show/NCT02459067

Link

https://clinicaltrials.gov/show/NCT02459067

Keywords

Versions (1)
  1. 5/8/19 5/8/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 8, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Melanoma NCT02459067

English

Eligibility Melanoma NCT02459067

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT02459067
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients aged ≥18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. performance status eastern cooperative oncology group (ecog) 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
3. subjects with histological or cytological confirmation of advanced metastatic melanoma, renal cell carcinoma or nsclc which are refractory to current standard treatments or who have indolent disease for which immunotherapy may be beneficial
Description

Metastatic melanoma Advanced | Metastatic Renal Cell Cancer Advanced | Non-small cell lung cancer metastatic Advanced | Standard therapy Refractory | Immunotherapy Disease indolent

Data type

boolean

Alias
UMLS CUI [1,1]
C0278883
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0278678
UMLS CUI [2,2]
C0205179
UMLS CUI [3,1]
C0278987
UMLS CUI [3,2]
C0205179
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C0205269
UMLS CUI [5,1]
C0021083
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0234227
4. measurable disease according to the irrc criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
5. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted <2 weeks prior to cycle 1:
Description

Bone Marrow function | Liver function | Renal function | Laboratory Results Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
UMLS CUI [4,1]
C1254595
UMLS CUI [4,2]
C1514873
creatinine ≤ 1.5 x upper limit of normal (uln) or a calculated creatinine clearance ≥ 50 ml/min
Description

Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C2711451
total bilirubin ≤ 1.5 x uln
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
alanine transaminase (alt) and aspartate transaminase (ast) ≤ 2.5 x uln or ≤ 5 x uln with liver metastases
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0494165
white blood cell count ≥3.0 x 109/l
Description

White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count (anc) ≥1.5 x 109/l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥100 x 109/l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
haemoglobin ≥ 10 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
6. life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
7. sufficient evidence of γδ t lymphocytes expansion in the proliferation assay at the first screening visit which will be a population doubling of γδ t lymphocytes ≥ 1.0 between 48-96 hours in culture.
Description

T-Lymphocyte Expanding Proliferation Assay | T-Lymphocyte Doubling

Data type

boolean

Alias
UMLS CUI [1,1]
C0039194
UMLS CUI [1,2]
C0205229
UMLS CUI [1,3]
C3899698
UMLS CUI [2,1]
C0039194
UMLS CUI [2,2]
C1705764
8. able to give informed, written consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
9. for female patients and female partners of male patients: must be surgically sterile, postmenopausal, or compliant with two forms of contraception (one of which must be a barrier method) during and for 6 months after the treatment period; female patients must have a negative urine or serum pregnancy test at screening and must not be breast-feeding.
Description

Female Sterilization | Gender Partner Female Sterilization | Postmenopausal state | Gender Contraceptive methods Quantity | Contraception, Barrier | Gender Urine pregnancy test negative | Gender Serum pregnancy test negative | Gender Breast Feeding Absent

Data type

boolean

Alias
UMLS CUI [1]
C0015787
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0682323
UMLS CUI [2,3]
C0015787
UMLS CUI [3]
C0232970
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C1265611
UMLS CUI [5]
C0004764
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0430057
UMLS CUI [7,1]
C0079399
UMLS CUI [7,2]
C0430061
UMLS CUI [8,1]
C0079399
UMLS CUI [8,2]
C0006147
UMLS CUI [8,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. other primary cancers apart from non-melanoma skin cancers, carcinoma - in situ of the cervix, or a prior cancer treated with curative intent more than 5 years ago without any evidence or recurrent disease
Description

Cancer Other Primary | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Curative treatment Malignant Neoplasm | Exception Recurrent disease Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0006826
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0277556
UMLS CUI [5,3]
C0332197
2. uncontrolled systemic infection
Description

Sepsis Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0243026
UMLS CUI [1,2]
C0205318
3. systemic steroid therapy or other immunosuppressants
Description

Steroid therapy Systemic | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C0021081
4. treatment with bisphosphonates, for instance zoledronate, in the previous 30 days and throughout the trial
Description

Diphosphonates | zoledronate

Data type

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0392938
5. new york heart association (nyha) functional class ≥3 or myocardial infarction within 6 months
Description

New York Heart Association Classification | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0027051
6. clinically-significant uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation not requiring therapy.
Description

Cardiac Arrhythmia Uncontrolled | Exception ATRIAL FIBRILLATION ASYMPTOMATIC

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0741277
7. ulcerative colitis / inflammatory bowel disease, addison's disease
Description

Ulcerative Colitis | Inflammatory Bowel Diseases | Addison Disease

Data type

boolean

Alias
UMLS CUI [1]
C0009324
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0001403
8. pregnancy or lactation before or during the trial. a urine or serum pregnancy test will be carried out at screening
Description

Pregnancy | Breast Feeding | Urine pregnancy test Performed | Serum pregnancy test Performed

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0430056
UMLS CUI [3,2]
C0884358
UMLS CUI [4,1]
C0430064
UMLS CUI [4,2]
C0884358
9. taking any other investigational medicinal product (imp) or participation in another interventional clinical trial in the previous 30 days
Description

Investigational New Drugs | Study Subject Participation Status | Interventional Study

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
UMLS CUI [3]
C3274035
10. less than 4 weeks since systemic anti-cancer therapy (tyrosine kinase inhibitors, chemotherapy, immunotherapy, hormonal therapy, radiotherapy) and less than 6 weeks since mitomycin c and nitrosureas
Description

Cancer treatment Systemic | Tyrosine kinase inhibitor | Chemotherapy | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Mitomycin | Nitrosoureas

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C1268567
UMLS CUI [3]
C0392920
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0279025
UMLS CUI [6]
C1522449
UMLS CUI [7]
C0002475
UMLS CUI [8]
C0028210
11. substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the trial or evaluation of the trial results
Description

Substance Use Disorders Interfere with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Psychological Factors Interfere with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Evaluation Research results | Psychological Factors Interfere with Evaluation Research results | Social Conditions Interfere with Evaluation Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C0038586
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0033898
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0037403
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
UMLS CUI [5,1]
C0038586
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C1261322
UMLS CUI [5,4]
C0683954
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C1261322
UMLS CUI [6,4]
C0683954
UMLS CUI [7,1]
C0033898
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C1261322
UMLS CUI [7,4]
C0683954
UMLS CUI [8,1]
C0037403
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C1261322
UMLS CUI [8,4]
C0683954
12. any other condition considered by a trial physician to be inappropriate for inclusion
Description

Condition Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
13. coagulation disorders - contraindications should also be taken into consideration during the leukapheresis procedure these include, contraindications to heparin which are: significant thrombocytopenia (platelet count less than 50x109/litre); recent cerebral haemorrhage; peptic ulcer; recent surgery to eye or nervous system; hypersensitivity to heparin; past history of type ii heparin induced thrombocytopenia; past history of significant spontaneous haemorrhage; known haemophilia or other bleeding disorder.
Description

Blood Coagulation Disorders | Leukapheresis | Medical contraindication Heparin | Thrombocytopenia | Platelet Count measurement | Cerebral Hemorrhage | Peptic Ulcer | Ophthalmologic Surgical Procedures | Neurosurgical Procedures | Heparin allergy | Heparin-induced thrombocytopenia Type | Spontaneous hemorrhage | Hemophilia

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2]
C0023416
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0019134
UMLS CUI [4]
C0040034
UMLS CUI [5]
C0032181
UMLS CUI [6]
C2937358
UMLS CUI [7]
C0030920
UMLS CUI [8]
C0038901
UMLS CUI [9]
C0524850
UMLS CUI [10]
C0571776
UMLS CUI [11,1]
C0272285
UMLS CUI [11,2]
C0332307
UMLS CUI [12]
C1321132
UMLS CUI [13]
C0684275
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Eligibility Melanoma NCT02459067

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility Melanoma NCT02459067
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. male or female patients aged ≥18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
2. performance status eastern cooperative oncology group (ecog) 0 or 1
boolean
C1520224 (UMLS CUI [1])
Metastatic melanoma Advanced | Metastatic Renal Cell Cancer Advanced | Non-small cell lung cancer metastatic Advanced | Standard therapy Refractory | Immunotherapy Disease indolent
Item
3. subjects with histological or cytological confirmation of advanced metastatic melanoma, renal cell carcinoma or nsclc which are refractory to current standard treatments or who have indolent disease for which immunotherapy may be beneficial
boolean
C0278883 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0278678 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0278987 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C0021083 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0234227 (UMLS CUI [5,3])
Measurable Disease
Item
4. measurable disease according to the irrc criteria
boolean
C1513041 (UMLS CUI [1])
Bone Marrow function | Liver function | Renal function | Laboratory Results Required
Item
5. adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted <2 weeks prior to cycle 1:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
C1254595 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
Creatinine measurement, serum | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine ≤ 1.5 x upper limit of normal (uln) or a calculated creatinine clearance ≥ 50 ml/min
boolean
C0201976 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Serum total bilirubin measurement
Item
total bilirubin ≤ 1.5 x uln
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Secondary malignant neoplasm of liver
Item
alanine transaminase (alt) and aspartate transaminase (ast) ≤ 2.5 x uln or ≤ 5 x uln with liver metastases
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
White Blood Cell Count procedure
Item
white blood cell count ≥3.0 x 109/l
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin ≥ 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Life Expectancy
Item
6. life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
T-Lymphocyte Expanding Proliferation Assay | T-Lymphocyte Doubling
Item
7. sufficient evidence of γδ t lymphocytes expansion in the proliferation assay at the first screening visit which will be a population doubling of γδ t lymphocytes ≥ 1.0 between 48-96 hours in culture.
boolean
C0039194 (UMLS CUI [1,1])
C0205229 (UMLS CUI [1,2])
C3899698 (UMLS CUI [1,3])
C0039194 (UMLS CUI [2,1])
C1705764 (UMLS CUI [2,2])
Informed Consent
Item
8. able to give informed, written consent
boolean
C0021430 (UMLS CUI [1])
Female Sterilization | Gender Partner Female Sterilization | Postmenopausal state | Gender Contraceptive methods Quantity | Contraception, Barrier | Gender Urine pregnancy test negative | Gender Serum pregnancy test negative | Gender Breast Feeding Absent
Item
9. for female patients and female partners of male patients: must be surgically sterile, postmenopausal, or compliant with two forms of contraception (one of which must be a barrier method) during and for 6 months after the treatment period; female patients must have a negative urine or serum pregnancy test at screening and must not be breast-feeding.
boolean
C0015787 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0682323 (UMLS CUI [2,2])
C0015787 (UMLS CUI [2,3])
C0232970 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0004764 (UMLS CUI [5])
C0079399 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
C0079399 (UMLS CUI [7,1])
C0430061 (UMLS CUI [7,2])
C0079399 (UMLS CUI [8,1])
C0006147 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
Item Group
C0680251 (UMLS CUI)
Cancer Other Primary | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Curative treatment Malignant Neoplasm | Exception Recurrent disease Absent
Item
1. other primary cancers apart from non-melanoma skin cancers, carcinoma - in situ of the cervix, or a prior cancer treated with curative intent more than 5 years ago without any evidence or recurrent disease
boolean
C1707251 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0006826 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Sepsis Uncontrolled
Item
2. uncontrolled systemic infection
boolean
C0243026 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Steroid therapy Systemic | Immunosuppressive Agents
Item
3. systemic steroid therapy or other immunosuppressants
boolean
C0149783 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2])
Diphosphonates | zoledronate
Item
4. treatment with bisphosphonates, for instance zoledronate, in the previous 30 days and throughout the trial
boolean
C0012544 (UMLS CUI [1])
C0392938 (UMLS CUI [2])
New York Heart Association Classification | Myocardial Infarction
Item
5. new york heart association (nyha) functional class ≥3 or myocardial infarction within 6 months
boolean
C1275491 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Cardiac Arrhythmia Uncontrolled | Exception ATRIAL FIBRILLATION ASYMPTOMATIC
Item
6. clinically-significant uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation not requiring therapy.
boolean
C0003811 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0741277 (UMLS CUI [2,2])
Ulcerative Colitis | Inflammatory Bowel Diseases | Addison Disease
Item
7. ulcerative colitis / inflammatory bowel disease, addison's disease
boolean
C0009324 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0001403 (UMLS CUI [3])
Pregnancy | Breast Feeding | Urine pregnancy test Performed | Serum pregnancy test Performed
Item
8. pregnancy or lactation before or during the trial. a urine or serum pregnancy test will be carried out at screening
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430056 (UMLS CUI [3,1])
C0884358 (UMLS CUI [3,2])
C0430064 (UMLS CUI [4,1])
C0884358 (UMLS CUI [4,2])
Investigational New Drugs | Study Subject Participation Status | Interventional Study
Item
9. taking any other investigational medicinal product (imp) or participation in another interventional clinical trial in the previous 30 days
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
C3274035 (UMLS CUI [3])
Cancer treatment Systemic | Tyrosine kinase inhibitor | Chemotherapy | Immunotherapy | Hormone Therapy | Therapeutic radiology procedure | Mitomycin | Nitrosoureas
Item
10. less than 4 weeks since systemic anti-cancer therapy (tyrosine kinase inhibitors, chemotherapy, immunotherapy, hormonal therapy, radiotherapy) and less than 6 weeks since mitomycin c and nitrosureas
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1268567 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C1522449 (UMLS CUI [6])
C0002475 (UMLS CUI [7])
C0028210 (UMLS CUI [8])
Substance Use Disorders Interfere with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Psychological Factors Interfere with Study Subject Participation Status | Social Conditions Interfere with Study Subject Participation Status | Substance Use Disorders Interfere with Evaluation Research results | Medical condition Interferes with Evaluation Research results | Psychological Factors Interfere with Evaluation Research results | Social Conditions Interfere with Evaluation Research results
Item
11. substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the trial or evaluation of the trial results
boolean
C0038586 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0033898 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0037403 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0038586 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C1261322 (UMLS CUI [5,3])
C0683954 (UMLS CUI [5,4])
C3843040 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
C0033898 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C1261322 (UMLS CUI [7,3])
C0683954 (UMLS CUI [7,4])
C0037403 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C1261322 (UMLS CUI [8,3])
C0683954 (UMLS CUI [8,4])
Condition Study Subject Participation Status Inappropriate
Item
12. any other condition considered by a trial physician to be inappropriate for inclusion
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
Blood Coagulation Disorders | Leukapheresis | Medical contraindication Heparin | Thrombocytopenia | Platelet Count measurement | Cerebral Hemorrhage | Peptic Ulcer | Ophthalmologic Surgical Procedures | Neurosurgical Procedures | Heparin allergy | Heparin-induced thrombocytopenia Type | Spontaneous hemorrhage | Hemophilia
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13. coagulation disorders - contraindications should also be taken into consideration during the leukapheresis procedure these include, contraindications to heparin which are: significant thrombocytopenia (platelet count less than 50x109/litre); recent cerebral haemorrhage; peptic ulcer; recent surgery to eye or nervous system; hypersensitivity to heparin; past history of type ii heparin induced thrombocytopenia; past history of significant spontaneous haemorrhage; known haemophilia or other bleeding disorder.
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C0005779 (UMLS CUI [1])
C0023416 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0019134 (UMLS CUI [3,2])
C0040034 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C2937358 (UMLS CUI [6])
C0030920 (UMLS CUI [7])
C0038901 (UMLS CUI [8])
C0524850 (UMLS CUI [9])
C0571776 (UMLS CUI [10])
C0272285 (UMLS CUI [11,1])
C0332307 (UMLS CUI [11,2])
C1321132 (UMLS CUI [12])
C0684275 (UMLS CUI [13])
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