ID

39212

Beskrivning

Antihypertensive Effect of Rostafuroxin Compared With Losartan in Hypertensive Patients Bearing Specified Gene Mutations; ODM derived from: https://clinicaltrials.gov/show/NCT01320397

Länk

https://clinicaltrials.gov/show/NCT01320397

Nyckelord

Versioner (1)
  1. 2019-12-11 2019-12-11 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

11 december 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Essential Hypertension NCT01320397

Engelsk

Eligibility Essential Hypertension NCT01320397

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
signature of a written informed consent, included informed consent on genotype analysis.
Beskrivning

Informed Consent | Informed Consent Genotype determination

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1285573
naive hypertensive patient (new diagnosed patient, never treated before).
Beskrivning

Patient Hypertensive Newly Diagnosed | Patient untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0857121
UMLS CUI [1,3]
C1518321
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0332155
documented mild to moderate arterial hypertension: sbp comprised between 140 and 169 mmhg and dbp between 85 and 100 mmhg;
Beskrivning

Hypertensive disease Mild | Hypertensive disease Moderate | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C2945599
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
presence of at least one mutated genotype or combination of genotypes corresponding to the list provided in the protocol.
Beskrivning

Genotype Mutated Quantity | Genotype Combination

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017431
UMLS CUI [1,2]
C1705285
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0017431
UMLS CUI [2,2]
C0205195
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
known causes of secondary or severe or malignant hypertension;
Beskrivning

Secondary hypertension | Hypertension, severe | Malignant Hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C4013784
UMLS CUI [3]
C0020540
significant renal or hepatic disease;
Beskrivning

Kidney Disease | Liver disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
cardiac disease requiring prohibited pharmacological treatment or history of myocardial infarction within the last 6 months;
Beskrivning

Heart Diseases | Requirement Pharmacotherapy Illicit | Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0013216
UMLS CUI [2,3]
C0332266
UMLS CUI [3]
C0027051
atrial fibrillation or complete ventricle bundle branch block;
Beskrivning

Atrial Fibrillation | Complete bundle branch block

Datatyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C3544314
first degree av-block exceeding 240 msec;
Beskrivning

First degree atrioventricular block

Datatyp

boolean

Alias
UMLS CUI [1]
C0085614
electrocardiographic evidence of left ventricular hypertrophy;
Beskrivning

ECG left ventricle hypertrophy

Datatyp

boolean

Alias
UMLS CUI [1]
C0232306
pregnant or nursing women or women of childbearing potential not taking anti-contraceptive medication or not utilizing a double contraceptive method;
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive Agents Absent | Childbearing Potential Contraceptive method Double Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0009871
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [4,3]
C0205173
UMLS CUI [4,4]
C0332197
concomitant therapy with medications that may affect blood pressure;
Beskrivning

Pharmaceutical Preparations Affecting Blood Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0005823
diabetes mellitus (fasting plasma glucose > 125 mg/dl);
Beskrivning

Diabetes Mellitus | Plasma fasting glucose measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0583513
statins treatment.
Beskrivning

Statin therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C1278454
Tillbaka till toppen

Similar models

Eligibility Essential Hypertension NCT01320397

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Genotype determination
Item
signature of a written informed consent, included informed consent on genotype analysis.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1285573 (UMLS CUI [2,2])
Patient Hypertensive Newly Diagnosed | Patient untreated
Item
naive hypertensive patient (new diagnosed patient, never treated before).
boolean
C0030705 (UMLS CUI [1,1])
C0857121 (UMLS CUI [1,2])
C1518321 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
Hypertensive disease Mild | Hypertensive disease Moderate | Systolic Pressure | Diastolic blood pressure
Item
documented mild to moderate arterial hypertension: sbp comprised between 140 and 169 mmhg and dbp between 85 and 100 mmhg;
boolean
C0020538 (UMLS CUI [1,1])
C2945599 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Genotype Mutated Quantity | Genotype Combination
Item
presence of at least one mutated genotype or combination of genotypes corresponding to the list provided in the protocol.
boolean
C0017431 (UMLS CUI [1,1])
C1705285 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0017431 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Secondary hypertension | Hypertension, severe | Malignant Hypertension
Item
known causes of secondary or severe or malignant hypertension;
boolean
C0155616 (UMLS CUI [1])
C4013784 (UMLS CUI [2])
C0020540 (UMLS CUI [3])
Kidney Disease | Liver disease
Item
significant renal or hepatic disease;
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
Heart Diseases | Requirement Pharmacotherapy Illicit | Myocardial Infarction
Item
cardiac disease requiring prohibited pharmacological treatment or history of myocardial infarction within the last 6 months;
boolean
C0018799 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0332266 (UMLS CUI [2,3])
C0027051 (UMLS CUI [3])
Atrial Fibrillation | Complete bundle branch block
Item
atrial fibrillation or complete ventricle bundle branch block;
boolean
C0004238 (UMLS CUI [1])
C3544314 (UMLS CUI [2])
First degree atrioventricular block
Item
first degree av-block exceeding 240 msec;
boolean
C0085614 (UMLS CUI [1])
ECG left ventricle hypertrophy
Item
electrocardiographic evidence of left ventricular hypertrophy;
boolean
C0232306 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive Agents Absent | Childbearing Potential Contraceptive method Double Absent
Item
pregnant or nursing women or women of childbearing potential not taking anti-contraceptive medication or not utilizing a double contraceptive method;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0009871 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0205173 (UMLS CUI [4,3])
C0332197 (UMLS CUI [4,4])
Pharmaceutical Preparations Affecting Blood Pressure
Item
concomitant therapy with medications that may affect blood pressure;
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,3])
Diabetes Mellitus | Plasma fasting glucose measurement
Item
diabetes mellitus (fasting plasma glucose > 125 mg/dl);
boolean
C0011849 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
Statin therapy
Item
statins treatment.
boolean
C1278454 (UMLS CUI [1])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial