ID

39937

Descripción

Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab; ODM derived from: https://clinicaltrials.gov/show/NCT01076140

Link

https://clinicaltrials.gov/show/NCT01076140

Palabras clave

Versiones (1)
  1. 5/3/20 5/3/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

5 de marzo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypertension NCT01076140

Inglés

Eligibility Hypertension NCT01076140

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients currently treated at the university of mississippi medical center oncology clinic
Descripción

Patients Treated Medical center

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0565990
patient is being treated with bevacizumab either alone or in combination with other agents for cancer
Descripción

bevacizumab | Combined Modality Therapy | Cancer treatment

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0796392
UMLS CUI [2]
C0009429
UMLS CUI [3]
C0920425
patient blood pressure is >140 mmhg (systolic) or > 90 mmhg (diastolic), either treated or untreated with medications for hypertension
Descripción

Systolic Pressure | Diastolic blood pressure | Pharmacotherapy Hypertensive disease | Pharmacotherapy Absent Hypertensive disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3,1]
C0013216
UMLS CUI [3,2]
C0020538
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0020538
patients may be currently on medications for hypertension (other than beta blocker, acei, or arb); these will be continued at the same dose throughout the study
Descripción

Antihypertensive Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Angiotensin-Converting Enzyme Inhibitors | Exception Angiotensin II receptor antagonist

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0304516
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003015
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0521942
patients should be > 18 years of age
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
patients receiving bevacizumab therapy approximately every 2 weeks
Descripción

bevacizumab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0796392
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of acei or arb induced angioedema or idiopathic/hereditary angioedema
Descripción

Angioedema due to angiotensin-converting-enzyme inhibitor | Angioedema Due to Angiotensin II receptor antagonist | Idiopathic angioedema | Angioedemas, Hereditary

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1304495
UMLS CUI [2,1]
C0002994
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0521942
UMLS CUI [3]
C1304177
UMLS CUI [4]
C0019243
patient currently treated with a beta blocker, acei, or arb or have a history of intolerance to a medication in any of these classes
Descripción

Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Intolerance to Adrenergic beta-1 Receptor Antagonists | Intolerance to Angiotensin-Converting Enzyme Inhibitors | Intolerance to Angiotensin II receptor antagonist

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0304516
UMLS CUI [2]
C0003015
UMLS CUI [3]
C0521942
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0304516
UMLS CUI [5,1]
C1744706
UMLS CUI [5,2]
C0003015
UMLS CUI [6,1]
C1744706
UMLS CUI [6,2]
C0521942
hyperkalemia, defined as a potassium value of >5 meq/l
Descripción

Hyperkalemia | Potassium measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020461
UMLS CUI [2]
C0202194
pregnancy or breastfeeding
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
severe renal impairment (egfr <30 ml/min)
Descripción

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
moderate hepatic impairment as identified by physician
Descripción

Hepatic impairment Moderate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0948807
UMLS CUI [1,2]
C0205081
currently taking cyp2d6 inducers (rifampin, carbamazepine or dexamethasone) or inhibitors (bupropion, fluoxetine, paroxetine, duloxetine, etc.)
Descripción

CYP2D6 Inducers | Rifampin | Carbamazepine | Dexamethasone | CYP2D6 Inhibitors | Bupropion | Fluoxetine | Paroxetine | duloxetine

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3850045
UMLS CUI [2]
C0035608
UMLS CUI [3]
C0006949
UMLS CUI [4]
C0011777
UMLS CUI [5]
C3850058
UMLS CUI [6]
C0085208
UMLS CUI [7]
C0016365
UMLS CUI [8]
C0070122
UMLS CUI [9]
C0245561
history of clinically significant ekg abnormality which would contraindicate beta blocker use
Descripción

ECG abnormal | Adrenergic beta-1 Receptor Antagonists Contraindicated

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C1444657
recent stroke (<6 months)
Descripción

Cerebrovascular accident Recent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0332185
recent myocardial infarction (<6 months)
Descripción

Myocardial Infarction Recent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0332185
congestive heart failure
Descripción

Congestive heart failure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
severe asthma or copd
Descripción

Severe asthma | Severe chronic obstructive pulmonary disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0581126
UMLS CUI [2]
C0730607
diagnosed obstructive sleep apnea
Descripción

Sleep Apnea, Obstructive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0520679
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Similar models

Eligibility Hypertension NCT01076140

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Patients Treated Medical center
Item
patients currently treated at the university of mississippi medical center oncology clinic
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0565990 (UMLS CUI [1,3])
bevacizumab | Combined Modality Therapy | Cancer treatment
Item
patient is being treated with bevacizumab either alone or in combination with other agents for cancer
boolean
C0796392 (UMLS CUI [1])
C0009429 (UMLS CUI [2])
C0920425 (UMLS CUI [3])
Systolic Pressure | Diastolic blood pressure | Pharmacotherapy Hypertensive disease | Pharmacotherapy Absent Hypertensive disease
Item
patient blood pressure is >140 mmhg (systolic) or > 90 mmhg (diastolic), either treated or untreated with medications for hypertension
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0013216 (UMLS CUI [3,1])
C0020538 (UMLS CUI [3,2])
C0013216 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0020538 (UMLS CUI [4,3])
Antihypertensive Agents | Exception Adrenergic beta-1 Receptor Antagonists | Exception Angiotensin-Converting Enzyme Inhibitors | Exception Angiotensin II receptor antagonist
Item
patients may be currently on medications for hypertension (other than beta blocker, acei, or arb); these will be continued at the same dose throughout the study
boolean
C0003364 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0304516 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0003015 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0521942 (UMLS CUI [4,2])
Age
Item
patients should be > 18 years of age
boolean
C0001779 (UMLS CUI [1])
bevacizumab
Item
patients receiving bevacizumab therapy approximately every 2 weeks
boolean
C0796392 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Angioedema due to angiotensin-converting-enzyme inhibitor | Angioedema Due to Angiotensin II receptor antagonist | Idiopathic angioedema | Angioedemas, Hereditary
Item
history of acei or arb induced angioedema or idiopathic/hereditary angioedema
boolean
C1304495 (UMLS CUI [1])
C0002994 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0521942 (UMLS CUI [2,3])
C1304177 (UMLS CUI [3])
C0019243 (UMLS CUI [4])
Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Intolerance to Adrenergic beta-1 Receptor Antagonists | Intolerance to Angiotensin-Converting Enzyme Inhibitors | Intolerance to Angiotensin II receptor antagonist
Item
patient currently treated with a beta blocker, acei, or arb or have a history of intolerance to a medication in any of these classes
boolean
C0304516 (UMLS CUI [1])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C1744706 (UMLS CUI [4,1])
C0304516 (UMLS CUI [4,2])
C1744706 (UMLS CUI [5,1])
C0003015 (UMLS CUI [5,2])
C1744706 (UMLS CUI [6,1])
C0521942 (UMLS CUI [6,2])
Hyperkalemia | Potassium measurement
Item
hyperkalemia, defined as a potassium value of >5 meq/l
boolean
C0020461 (UMLS CUI [1])
C0202194 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate
Item
severe renal impairment (egfr <30 ml/min)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Hepatic impairment Moderate
Item
moderate hepatic impairment as identified by physician
boolean
C0948807 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
CYP2D6 Inducers | Rifampin | Carbamazepine | Dexamethasone | CYP2D6 Inhibitors | Bupropion | Fluoxetine | Paroxetine | duloxetine
Item
currently taking cyp2d6 inducers (rifampin, carbamazepine or dexamethasone) or inhibitors (bupropion, fluoxetine, paroxetine, duloxetine, etc.)
boolean
C3850045 (UMLS CUI [1])
C0035608 (UMLS CUI [2])
C0006949 (UMLS CUI [3])
C0011777 (UMLS CUI [4])
C3850058 (UMLS CUI [5])
C0085208 (UMLS CUI [6])
C0016365 (UMLS CUI [7])
C0070122 (UMLS CUI [8])
C0245561 (UMLS CUI [9])
ECG abnormal | Adrenergic beta-1 Receptor Antagonists Contraindicated
Item
history of clinically significant ekg abnormality which would contraindicate beta blocker use
boolean
C0522055 (UMLS CUI [1])
C0304516 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
Cerebrovascular accident Recent
Item
recent stroke (<6 months)
boolean
C0038454 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Myocardial Infarction Recent
Item
recent myocardial infarction (<6 months)
boolean
C0027051 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Congestive heart failure
Item
congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Severe asthma | Severe chronic obstructive pulmonary disease
Item
severe asthma or copd
boolean
C0581126 (UMLS CUI [1])
C0730607 (UMLS CUI [2])
Sleep Apnea, Obstructive
Item
diagnosed obstructive sleep apnea
boolean
C0520679 (UMLS CUI [1])
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