ID

40333

Beskrivning

Study 1: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02133872

Länk

https://clinicaltrials.gov/show/NCT02133872

Nyckelord

Versioner (1)
  1. 2020-04-09 2020-04-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 april 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT02133872

Engelsk

Eligibility Hypertension NCT02133872

1 Formulär  
Criteria
Beskrivning

Criteria

greater than 18 and less than 80 years of age;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
on stable medication regimen
Beskrivning

Pharmacotherapy Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
full-tolerated doses of 3 or more antihypertensive medications of different classes, one of which must be a diuretic (with no changes for a minimum of two weeks prior to screening) that is expected to be maintained without changes for at least 3 months.
Beskrivning

Antihypertensive Agents Quantity Maximum Tolerated Dose | Antihypertensive Agents Class Different | Diuretics Quantity | Diuretic unchanged

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0752079
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0456387
UMLS CUI [2,3]
C1705242
UMLS CUI [3,1]
C0012798
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0012798
UMLS CUI [4,2]
C0442739
the individual agrees to have all study procedures performed
Beskrivning

Study procedures Performed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0184661
UMLS CUI [1,3]
C0884358
willing to provide written consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
exclusion
Beskrivning

Exclusion Criteria

Datatyp

boolean

Alias
UMLS CUI [1]
C0680251
egfr of < 45ml/min/1.73m2, using the mdrd calculation.
Beskrivning

GFR estimation by MDRD

Datatyp

boolean

Alias
UMLS CUI [1]
C2170215
more than one in-patient hospitalization for an antihypertensive crisis within the year.
Beskrivning

Hospitalization Quantity Hypertensive disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020538
more than one episode(s) of orthostatic hypotension (reduction of sbp of ≥ 20mmhg of diastolic blood pressure (dbp) of ≥ 10mmhg within 3 minutes of standing).
Beskrivning

Episode Quantity Orthostatic Hypotension | Standing systolic blood pressure Reduced | Standing diastolic blood pressure Reduced

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332189
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0020651
UMLS CUI [2,1]
C1303018
UMLS CUI [2,2]
C0392756
UMLS CUI [3,1]
C1303019
UMLS CUI [3,2]
C0392756
known hypersensitivity or contraindication to minocycline or other tetracycline.
Beskrivning

Minocycline allergy | Tetracycline allergy | Medical contraindication Minocycline | Medical contraindication Tetracycline

Datatyp

boolean

Alias
UMLS CUI [1]
C0571498
UMLS CUI [2]
C0039645
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0026187
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0039644
evidence of alcoholism or drug abuse;
Beskrivning

Alcoholic Intoxication, Chronic | Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013146
concurrent severe disease (such as neoplasm or hiv positive or aids).
Beskrivning

Comorbidity Severe | Neoplasms | HIV Seropositivity | AIDS

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0027651
UMLS CUI [3]
C0019699
UMLS CUI [4]
C0001175
women of childbearing potential
Beskrivning

Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
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Similar models

Eligibility Hypertension NCT02133872

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Age
Item
greater than 18 and less than 80 years of age;
boolean
C0001779 (UMLS CUI [1])
Pharmacotherapy Stable
Item
on stable medication regimen
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Antihypertensive Agents Quantity Maximum Tolerated Dose | Antihypertensive Agents Class Different | Diuretics Quantity | Diuretic unchanged
Item
full-tolerated doses of 3 or more antihypertensive medications of different classes, one of which must be a diuretic (with no changes for a minimum of two weeks prior to screening) that is expected to be maintained without changes for at least 3 months.
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0752079 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C0456387 (UMLS CUI [2,2])
C1705242 (UMLS CUI [2,3])
C0012798 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4,1])
C0442739 (UMLS CUI [4,2])
Study procedures Performed
Item
the individual agrees to have all study procedures performed
boolean
C2348563 (UMLS CUI [1,1])
C0184661 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
Informed Consent
Item
willing to provide written consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria
Item
exclusion
boolean
C0680251 (UMLS CUI [1])
GFR estimation by MDRD
Item
egfr of < 45ml/min/1.73m2, using the mdrd calculation.
boolean
C2170215 (UMLS CUI [1])
Hospitalization Quantity Hypertensive disease
Item
more than one in-patient hospitalization for an antihypertensive crisis within the year.
boolean
C0019993 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,3])
Episode Quantity Orthostatic Hypotension | Standing systolic blood pressure Reduced | Standing diastolic blood pressure Reduced
Item
more than one episode(s) of orthostatic hypotension (reduction of sbp of ≥ 20mmhg of diastolic blood pressure (dbp) of ≥ 10mmhg within 3 minutes of standing).
boolean
C0332189 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0020651 (UMLS CUI [1,3])
C1303018 (UMLS CUI [2,1])
C0392756 (UMLS CUI [2,2])
C1303019 (UMLS CUI [3,1])
C0392756 (UMLS CUI [3,2])
Minocycline allergy | Tetracycline allergy | Medical contraindication Minocycline | Medical contraindication Tetracycline
Item
known hypersensitivity or contraindication to minocycline or other tetracycline.
boolean
C0571498 (UMLS CUI [1])
C0039645 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0026187 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C0039644 (UMLS CUI [4,2])
Alcoholic Intoxication, Chronic | Drug abuse
Item
evidence of alcoholism or drug abuse;
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Comorbidity Severe | Neoplasms | HIV Seropositivity | AIDS
Item
concurrent severe disease (such as neoplasm or hiv positive or aids).
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
C0001175 (UMLS CUI [4])
Childbearing Potential
Item
women of childbearing potential
boolean
C3831118 (UMLS CUI [1])
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