ID

40505

Description

Ischemia Care Biomarkers of Acute Stroke Etiology (BASE); ODM derived from: https://clinicaltrials.gov/show/NCT02014896

Link

https://clinicaltrials.gov/show/NCT02014896

Keywords

Versions (1)
  1. 4/27/20 4/27/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 27, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Ischemic Stroke NCT02014896

English

Eligibility Ischemic Stroke NCT02014896

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients >18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
signs and symptoms suggestive of acute ischemic stroke or tia arrival to the emergency department or hospital within 8 hrs of symptom onset or last known normal time
Description

Signs and Symptoms Suggestive of Ischemic stroke | Signs and Symptoms Suggestive of Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0332299
UMLS CUI [1,3]
C0948008
UMLS CUI [2,1]
C0037088
UMLS CUI [2,2]
C0332299
UMLS CUI [2,3]
C0007787
head ct or mri ruling out other pathology such as vascular malformation, hemorrhage, tumor or abscess which would likely be responsible for presenting neurologic symptoms
Description

CT of head | MRI of head | Vascular anomaly Excluded | Hemorrhage Excluded | Neoplasm Excluded | Abscess Excluded

Data type

boolean

Alias
UMLS CUI [1]
C0202691
UMLS CUI [2]
C0412674
UMLS CUI [3,1]
C0158570
UMLS CUI [3,2]
C0332196
UMLS CUI [4,1]
C0019080
UMLS CUI [4,2]
C0332196
UMLS CUI [5,1]
C0027651
UMLS CUI [5,2]
C0332196
UMLS CUI [6,1]
C0000833
UMLS CUI [6,2]
C0332196
consent must be obtained
Description

Informed Consent Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1514873
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any central nervous system infection, i.e. meningitis or encephalitis in the past 30 days
Description

Central Nervous System Infection | Meningitis | Encephalitis

Data type

boolean

Alias
UMLS CUI [1]
C0007684
UMLS CUI [2]
C0025289
UMLS CUI [3]
C0014038
any form of head trauma, stroke or intracranial hemorrhage in the past 30 days
Description

Craniocerebral Trauma | Cerebrovascular accident | Intracranial Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0018674
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0151699
known primary or metastatic cancer involving the brain
Description

Malignant neoplasm of brain | Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0153633
UMLS CUI [2]
C0220650
active cancer defined as a diagnosis of cancer, within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer.
Description

Malignant Neoplasms | Cancer treatment | Recurrent Carcinoma | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0920425
UMLS CUI [3]
C0549379
UMLS CUI [4]
C0027627
autoimmune diseases: such as lupus, rheumatoid arthritis, crohn's disease, ulcerative colitis
Description

Autoimmune Diseases | Lupus Erythematosus | Rheumatoid Arthritis | Crohn Disease | Ulcerative Colitis

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0409974
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0010346
UMLS CUI [5]
C0009324
active infectious diseases (eg. hiv/aids, hepatitis c)
Description

Communicable Diseases | HIV Infection | AIDS | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0001175
UMLS CUI [4]
C0019196
any underlying medical condition which in the opinion of the investigator would prohibit the patient from providing informed consent
Description

Medical condition Preventing Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
major surgery within three months prior to the index event
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
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Similar models

Eligibility Ischemic Stroke NCT02014896

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients >18 years of age
boolean
C0001779 (UMLS CUI [1])
Signs and Symptoms Suggestive of Ischemic stroke | Signs and Symptoms Suggestive of Transient Ischemic Attack
Item
signs and symptoms suggestive of acute ischemic stroke or tia arrival to the emergency department or hospital within 8 hrs of symptom onset or last known normal time
boolean
C0037088 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0948008 (UMLS CUI [1,3])
C0037088 (UMLS CUI [2,1])
C0332299 (UMLS CUI [2,2])
C0007787 (UMLS CUI [2,3])
CT of head | MRI of head | Vascular anomaly Excluded | Hemorrhage Excluded | Neoplasm Excluded | Abscess Excluded
Item
head ct or mri ruling out other pathology such as vascular malformation, hemorrhage, tumor or abscess which would likely be responsible for presenting neurologic symptoms
boolean
C0202691 (UMLS CUI [1])
C0412674 (UMLS CUI [2])
C0158570 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0019080 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0027651 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0000833 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
Informed Consent Required
Item
consent must be obtained
boolean
C0021430 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Central Nervous System Infection | Meningitis | Encephalitis
Item
any central nervous system infection, i.e. meningitis or encephalitis in the past 30 days
boolean
C0007684 (UMLS CUI [1])
C0025289 (UMLS CUI [2])
C0014038 (UMLS CUI [3])
Craniocerebral Trauma | Cerebrovascular accident | Intracranial Hemorrhage
Item
any form of head trauma, stroke or intracranial hemorrhage in the past 30 days
boolean
C0018674 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0151699 (UMLS CUI [3])
Malignant neoplasm of brain | Metastatic malignant neoplasm to brain
Item
known primary or metastatic cancer involving the brain
boolean
C0153633 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Malignant Neoplasms | Cancer treatment | Recurrent Carcinoma | Neoplasm Metastasis
Item
active cancer defined as a diagnosis of cancer, within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer.
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C0549379 (UMLS CUI [3])
C0027627 (UMLS CUI [4])
Autoimmune Diseases | Lupus Erythematosus | Rheumatoid Arthritis | Crohn Disease | Ulcerative Colitis
Item
autoimmune diseases: such as lupus, rheumatoid arthritis, crohn's disease, ulcerative colitis
boolean
C0004364 (UMLS CUI [1])
C0409974 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0010346 (UMLS CUI [4])
C0009324 (UMLS CUI [5])
Communicable Diseases | HIV Infection | AIDS | Hepatitis C
Item
active infectious diseases (eg. hiv/aids, hepatitis c)
boolean
C0009450 (UMLS CUI [1])
C0019693 (UMLS CUI [2])
C0001175 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Medical condition Preventing Informed Consent
Item
any underlying medical condition which in the opinion of the investigator would prohibit the patient from providing informed consent
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Major surgery
Item
major surgery within three months prior to the index event
boolean
C0679637 (UMLS CUI [1])
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