ID

32585

Description

Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00607477

Link

https://clinicaltrials.gov/show/NCT00607477

Keywords

Versions (1)
  1. 11/7/18 11/7/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

November 7, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Treatment Induced Hypertension NCT00607477

English

Eligibility Treatment Induced Hypertension NCT00607477

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ongoing treatment for malignancy by at the university of chicago with any agent with recognized, specific inhibition of vegf, vegf-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. these agents include but are not limited to: bevacizumab (avastin™), sorafenib (nexavar™), sunitinib (sutent™), axitinib (ag-013736), and azd 2171.
Description

Cancer treatment | Vascular Endothelial Growth Factor Inhibitors | Vascular Endothelial Growth Factor Receptor inhibitors | bevacizumab | Avastin | sorafenib | Nexavar | sunitinib | Sutent | axitinib | AG 013736 | AZD2171

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C4522891
UMLS CUI [3,1]
C0148199
UMLS CUI [3,2]
C0243077
UMLS CUI [4]
C0796392
UMLS CUI [5]
C1135130
UMLS CUI [6]
C1516119
UMLS CUI [7]
C1677799
UMLS CUI [8]
C1176020
UMLS CUI [9]
C1698963
UMLS CUI [10]
C1700874
UMLS CUI [11]
C1328149
UMLS CUI [12]
C1541530
treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmhg.
Description

Antihypertensive therapy | Antihypertensive Agents Quantity | Blood pressure determination

Data type

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C1265611
UMLS CUI [3]
C0005824
stable management of other toxicities from the cancer treatments
Description

Toxicity Due to Cancer treatment | Management Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0920425
UMLS CUI [2,1]
C0376636
UMLS CUI [2,2]
C0205360
expected to continue current cancer treatments for at least 4 weeks
Description

Cancer treatment Duration Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1517001
18 years and older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
concurrent use of hematopoietic supportive treatment with erythropoietin or congeners.
Description

Erythropoietin | Erythropoietin congener

Data type

boolean

Alias
UMLS CUI [1]
C0014822
UMLS CUI [2,1]
C0014822
UMLS CUI [2,2]
C0678518
current uncontrolled toxicities due to the cancer treatments.
Description

Toxicity Uncontrolled | Toxicity Due to Cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0920425
patients having known contraindications to hydralazine or minoxidil therapy.
Description

Medical contraindication Hydralazine | Medical contraindication Minoxidil

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0020223
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0026196
any readings of systolic blood pressure >200 mmhg or diastolic blood pressure >120 mmhg in the four (4) weeks prior to screening.
Description

Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
use of either minoxidil or hydralazine in the six (6) months prior to screening.
Description

Minoxidil | Hydralazine

Data type

boolean

Alias
UMLS CUI [1]
C0026196
UMLS CUI [2]
C0020223
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Similar models

Eligibility Treatment Induced Hypertension NCT00607477

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Cancer treatment | Vascular Endothelial Growth Factor Inhibitors | Vascular Endothelial Growth Factor Receptor inhibitors | bevacizumab | Avastin | sorafenib | Nexavar | sunitinib | Sutent | axitinib | AG 013736 | AZD2171
Item
ongoing treatment for malignancy by at the university of chicago with any agent with recognized, specific inhibition of vegf, vegf-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. these agents include but are not limited to: bevacizumab (avastin™), sorafenib (nexavar™), sunitinib (sutent™), axitinib (ag-013736), and azd 2171.
boolean
C0920425 (UMLS CUI [1])
C4522891 (UMLS CUI [2])
C0148199 (UMLS CUI [3,1])
C0243077 (UMLS CUI [3,2])
C0796392 (UMLS CUI [4])
C1135130 (UMLS CUI [5])
C1516119 (UMLS CUI [6])
C1677799 (UMLS CUI [7])
C1176020 (UMLS CUI [8])
C1698963 (UMLS CUI [9])
C1700874 (UMLS CUI [10])
C1328149 (UMLS CUI [11])
C1541530 (UMLS CUI [12])
Antihypertensive therapy | Antihypertensive Agents Quantity | Blood pressure determination
Item
treatment of hypertension with at least 2 or more anti-hypertensive medications with blood pressure remaining greater than 140/90 mmhg.
boolean
C0585941 (UMLS CUI [1])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0005824 (UMLS CUI [3])
Toxicity Due to Cancer treatment | Management Stable
Item
stable management of other toxicities from the cancer treatments
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0920425 (UMLS CUI [1,3])
C0376636 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
Cancer treatment Duration Expected
Item
expected to continue current cancer treatments for at least 4 weeks
boolean
C0920425 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Age
Item
18 years and older
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Erythropoietin | Erythropoietin congener
Item
concurrent use of hematopoietic supportive treatment with erythropoietin or congeners.
boolean
C0014822 (UMLS CUI [1])
C0014822 (UMLS CUI [2,1])
C0678518 (UMLS CUI [2,2])
Toxicity Uncontrolled | Toxicity Due to Cancer treatment
Item
current uncontrolled toxicities due to the cancer treatments.
boolean
C0600688 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0920425 (UMLS CUI [2,3])
Medical contraindication Hydralazine | Medical contraindication Minoxidil
Item
patients having known contraindications to hydralazine or minoxidil therapy.
boolean
C1301624 (UMLS CUI [1,1])
C0020223 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0026196 (UMLS CUI [2,2])
Systolic Pressure | Diastolic blood pressure
Item
any readings of systolic blood pressure >200 mmhg or diastolic blood pressure >120 mmhg in the four (4) weeks prior to screening.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Minoxidil | Hydralazine
Item
use of either minoxidil or hydralazine in the six (6) months prior to screening.
boolean
C0026196 (UMLS CUI [1])
C0020223 (UMLS CUI [2])
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