ID

32585

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00607477

Nyckelord

  1. 2018-11-07 2018-11-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 november 2018

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Treatment Induced Hypertension NCT00607477

Eligibility Treatment Induced Hypertension NCT00607477

Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Antihypertensive therapy | Antihypertensive Agents Quantity | Blood pressure determination

Datatyp

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
Beskrivning

Toxicity Due to Cancer treatment | Management Stable

Datatyp

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
Beskrivning

Cancer treatment Duration Expected

Datatyp

boolean

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

Age

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

Erythropoietin | Erythropoietin congener

Datatyp

boolean

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

Toxicity Uncontrolled | Toxicity Due to Cancer treatment

Datatyp

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.
Beskrivning

Medical contraindication Hydralazine | Medical contraindication Minoxidil

Datatyp

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.
Beskrivning

Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

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

Minoxidil | Hydralazine

Datatyp

boolean

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

Similar models

Eligibility Treatment Induced Hypertension NCT00607477

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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