ID

15288

Beschreibung

Study 2: Effect of Minocycline Treatment on Drug-Resistant Hypertensive Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02133885

Link

https://clinicaltrials.gov/show/NCT02133885

Stichworte

Versionen (1)
  1. 25.05.16 25.05.16 -
Hochgeladen am

25. Mai 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Hypertension NCT02133885

Englisch

Eligibility Hypertension NCT02133885

1 Formulare  
Criteria
Beschreibung

Criteria

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

Age

Datentyp

boolean

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

Pharmaceutical Preparations Stable status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205360
o full-tolerated doses of 3 or more anti-hypertensive 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 6-9 months.
Beschreibung

Antihypertensive Agents | Diuretics | Change of medication

Datentyp

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2]
C0012798
UMLS CUI [3]
C0580105
office systolic blood pressure (sbp) of greater than 160 mmhg based on an average of 3 blood pressure readings measured at both initial screening visit
Beschreibung

Systolic Pressure Office | blood pressure reading

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0442603
UMLS CUI [2]
C0436781
the individual agrees to have all study procedures performed
Beschreibung

Compliance behavior | Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C2348563
willing to provide written consent
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
females with childbearing potential must not be pregnant.
Beschreibung

Childbearing Potential | Not pregnant

Datentyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0232973
exclusion
Beschreibung

Exclusion Criteria

Datentyp

boolean

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

renal function GFR estimation by MDRD

Datentyp

boolean

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

Hypertension Adverse Event Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1963138
UMLS CUI [1,2]
C0019993
more than one episode(s) of orthostatic hypotension (reduction of sbp of ≥ 20 mmhg of diastolic blood pressure (dbp) of ≥ 10 mmhg within 3 minutes of standing).
Beschreibung

Orthostatic Hypotension Episode | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020651
UMLS CUI [1,2]
C0332189
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
history of myocardial infarction (mi), unstable angina pectoris, syncope or a cardiovascular accident within 6 months of screening period
Beschreibung

Myocardial Infarction | Angina, Unstable | Syncope, Cardiogenic | Accident; cardiovascular

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0751535
UMLS CUI [4]
C1386002
clinically significant atrioventricular (av) conduction disturbances and/or arrhythmias (e.g. 2nd or 3rd degree av block);
Beschreibung

Atrioventricular conduction disturbances | Cardiac Arrhythmia | Atrioventricular Block

Datentyp

boolean

Alias
UMLS CUI [1]
C1834655
UMLS CUI [2]
C0003811
UMLS CUI [3]
C0004245
current of past history of heart failure (≤40% left ventricular ejection fraction (ef).
Beschreibung

Heart failure | Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2]
C0428772
major of psychotropic agents and antidepressants.
Beschreibung

Psychotropic Drugs Major | Antidepressive Agents Major

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0033978
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0003289
UMLS CUI [2,2]
C0205164
use of nonsteroidal anti-inflammatory drug (nsaids)
Beschreibung

Anti-Inflammatory Agents, Non-Steroidal

Datentyp

boolean

Alias
UMLS CUI [1]
C0003211
known hypersensitivity or contraindication to minocycline or other tetracycline.
Beschreibung

Hypersensitivity Minocycline | Hypersensitivity Tetracycline | Medical contraindication Minocycline Tetracycline

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0026187
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0039644
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0026187
UMLS CUI [3,3]
C0039644
smoking
Beschreibung

Smoking

Datentyp

boolean

Alias
UMLS CUI [1]
C0037369
concurrent severe disease (such as neoplasm or hiv positive or aids).
Beschreibung

Comorbidity Severe | Neoplasms | HIV Seropositivity | Acquired Immunodeficiency Syndrome

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0027651
UMLS CUI [3]
C0019699
UMLS CUI [4]
C0001175
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Ähnliche Modelle

Eligibility Hypertension NCT02133885

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Age
Item
greater than 18 and less than 80 years of age;
boolean
C0001779 (UMLS CUI [1])
Pharmaceutical Preparations Stable status
Item
on stable medication regimen
boolean
C0013227 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Antihypertensive Agents | Diuretics | Change of medication
Item
o full-tolerated doses of 3 or more anti-hypertensive 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 6-9 months.
boolean
C0003364 (UMLS CUI [1])
C0012798 (UMLS CUI [2])
C0580105 (UMLS CUI [3])
Systolic Pressure Office | blood pressure reading
Item
office systolic blood pressure (sbp) of greater than 160 mmhg based on an average of 3 blood pressure readings measured at both initial screening visit
boolean
C0871470 (UMLS CUI [1,1])
C0442603 (UMLS CUI [1,2])
C0436781 (UMLS CUI [2])
Compliance behavior | Study Protocol
Item
the individual agrees to have all study procedures performed
boolean
C1321605 (UMLS CUI [1])
C2348563 (UMLS CUI [2])
Informed consent
Item
willing to provide written consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential | Not pregnant
Item
females with childbearing potential must not be pregnant.
boolean
C3831118 (UMLS CUI [1])
C0232973 (UMLS CUI [2])
Exclusion Criteria
Item
exclusion
boolean
C0680251 (UMLS CUI [1])
renal function GFR estimation by MDRD
Item
egfr of < 45 ml/min/1.73m2, using the mdrd calculation.
boolean
C2170215 (UMLS CUI [1])
Hypertension Adverse Event Hospitalization
Item
more than one in-patient hospitalization for an anti-hypertensive crisis within the year.
boolean
C1963138 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
Orthostatic Hypotension Episode | Systolic Pressure | Diastolic blood pressure
Item
more than one episode(s) of orthostatic hypotension (reduction of sbp of ≥ 20 mmhg of diastolic blood pressure (dbp) of ≥ 10 mmhg within 3 minutes of standing).
boolean
C0020651 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Myocardial Infarction | Angina, Unstable | Syncope, Cardiogenic | Accident; cardiovascular
Item
history of myocardial infarction (mi), unstable angina pectoris, syncope or a cardiovascular accident within 6 months of screening period
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0751535 (UMLS CUI [3])
C1386002 (UMLS CUI [4])
Atrioventricular conduction disturbances | Cardiac Arrhythmia | Atrioventricular Block
Item
clinically significant atrioventricular (av) conduction disturbances and/or arrhythmias (e.g. 2nd or 3rd degree av block);
boolean
C1834655 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0004245 (UMLS CUI [3])
Heart failure | Left ventricular ejection fraction
Item
current of past history of heart failure (≤40% left ventricular ejection fraction (ef).
boolean
C0018801 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Psychotropic Drugs Major | Antidepressive Agents Major
Item
major of psychotropic agents and antidepressants.
boolean
C0033978 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0003289 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
Anti-Inflammatory Agents, Non-Steroidal
Item
use of nonsteroidal anti-inflammatory drug (nsaids)
boolean
C0003211 (UMLS CUI [1])
Hypersensitivity Minocycline | Hypersensitivity Tetracycline | Medical contraindication Minocycline Tetracycline
Item
known hypersensitivity or contraindication to minocycline or other tetracycline.
boolean
C0020517 (UMLS CUI [1,1])
C0026187 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0039644 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0026187 (UMLS CUI [3,2])
C0039644 (UMLS CUI [3,3])
Smoking
Item
smoking
boolean
C0037369 (UMLS CUI [1])
Comorbidity Severe | Neoplasms | HIV Seropositivity | Acquired Immunodeficiency Syndrome
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])
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