ID

39934

Beschreibung

A Trial of Telmisartan Prevention of Cardiovascular Disease; ODM derived from: https://clinicaltrials.gov/show/NCT01075698

Link

https://clinicaltrials.gov/show/NCT01075698

Stichworte

Versionen (2)
  1. 04.03.20 04.03.20 -
  2. 05.03.20 05.03.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. März 2020

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Hypertension NCT01075698

Englisch

Eligibility Hypertension NCT01075698

1 Formulare  
Criteria
Beschreibung

Criteria

1. outpatients
Beschreibung

Outpatients

Datentyp

boolean

Alias
UMLS CUI [1]
C0029921
2. age: ≥ 40 to < 80
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
3. hypertension: systolic blood pressure of ≥ 140 mmhg or diastolic blood pressure of ≥
Beschreibung

Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
90 mmhg in the two latest measurements of casual blood pressure (in the sitting position) regardless of treated or untreated condition, or systolic blood pressure of < 140 mmhg and diastolic blood pressure of < 90 mmhg that require antihypertensive treatment.
Beschreibung

Sitting blood pressure | Systolic Pressure | Diastolic blood pressure | Requirement Antihypertensive therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0580946
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0585941
assessment of hypertension: blood pressure will be measured at least twice at an interval of 1 to 2 minutes. if the measured values obtained are substantially different, additional measurements will be performed and the average of two stable measurements will be used for assessment.
Beschreibung

Assessment Hypertensive disease | Blood pressure determination | Average Measurement Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C0020538
UMLS CUI [2]
C0005824
UMLS CUI [3,1]
C1510992
UMLS CUI [3,2]
C0242485
UMLS CUI [3,3]
C1265611
4. patients who have given consent to participate in the present study.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
cardiovascular risks:
Beschreibung

Cardiovascular risk

Datentyp

boolean

Alias
UMLS CUI [1]
C4324389
1. diabetes mellitus; type 2 diabetes mellitus
Beschreibung

Diabetes Mellitus | Diabetes Mellitus, Non-Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0011860
2. kidney; serum creatinine: 1.2 mg/dl - < 2.0 mg/dl for males, 1.0 mg/dl - < 2.0 mg/dl for females proteinuria: qualitative value of ≥ +1 (quantitative value: proteinuria with the value of ≥ 0.3 g/g・cr in casual urine when adjusted with urine creatinine) ckd stage 3 or higher (gfr < 60 ml/min/1.73 m2)
Beschreibung

Kidney | Creatinine measurement, serum | Gender | Proteinuria | Chronic kidney disease stage | Glomerular Filtration Rate

Datentyp

boolean

Alias
UMLS CUI [1]
C0022646
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0033687
UMLS CUI [5]
C2074731
UMLS CUI [6]
C0017654
3. heart; previous myocardial infarction noted more than 6 months before obtaining the informed consent diagnosis of angina pectoris diagnosis of heart failure (nyha i or ii class) diagnosis of left ventricular hypertrophy (left ventricular posterior wall of ≥ 12 mm evidenced by echocardiography performed prior to obtaining the informed consent, or sv1+rv5 of ≥ 35 mm noted as ecg finding) diagnosis of transient or persisting atrial fibrillation
Beschreibung

Heart | Myocardial Infarction | Angina Pectoris | Heart failure New York Heart Association Classification | Left Ventricular Hypertrophy | Echocardiography for determining posterior left ventricular wall thickness | Atrial Fibrillation Transient | Persistent atrial fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0018787
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002962
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1275491
UMLS CUI [5]
C0149721
UMLS CUI [6]
C0203366
UMLS CUI [7,1]
C0004238
UMLS CUI [7,2]
C0205374
UMLS CUI [8]
C2585653
4. brain; previous cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient cerebral ischemic attack noted more than 6 months before obtaining the informed consent
Beschreibung

Brain | Cerebral Infarction | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0006104
UMLS CUI [2]
C0007785
UMLS CUI [3]
C2937358
UMLS CUI [4]
C0038525
UMLS CUI [5]
C0007787
5. peripheral arterial diseases; previous lower-limb bypass surgery or angioplasty performed more than 6 months before obtaining the informed consent ankle-brachial pressure index of < 0.9 or intermittent claudication
Beschreibung

Peripheral Arterial Diseases | Peripheral artery bypass Lower limb | Angioplasty Lower limb | Ankle brachial pressure index | Intermittent Claudication

Datentyp

boolean

Alias
UMLS CUI [1]
C1704436
UMLS CUI [2,1]
C3495795
UMLS CUI [2,2]
C0023216
UMLS CUI [3,1]
C0162577
UMLS CUI [3,2]
C0023216
UMLS CUI [4]
C1276055
UMLS CUI [5]
C0021775
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who meet any of the following criteria will be excluded from the study.
Beschreibung

Criteria Any Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1552551
UMLS CUI [1,3]
C1550543
1. type 1 diabetes mellitus
Beschreibung

Diabetes Mellitus, Insulin-Dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0011854
2. severe renal disorders (serum creatinine of ≥ 2.0 mg/dl)
Beschreibung

Kidney Diseases Severe | Creatinine measurement, serum

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0201976
3. myocardial infarction, percutaneous transluminal angioplasty and bypass surgery of coronary artery/ lower-limb blood vessel, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage and transient cerebral ischemic attack noted within 6 months before initiation of the observation
Beschreibung

Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Blood vessel of lower limb Bypass | Cerebral Infarction | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C2936173
UMLS CUI [3]
C0010055
UMLS CUI [4,1]
C4517177
UMLS CUI [4,2]
C0741847
UMLS CUI [5]
C0007785
UMLS CUI [6]
C2937358
UMLS CUI [7]
C0038525
UMLS CUI [8]
C0007787
4. diagnosis of heart failure (nyha iii or iv class )
Beschreibung

Heart failure New York Heart Association Classification

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
5. virulent hypertension and secondary hypertension
Beschreibung

Malignant Hypertension | Secondary hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0020540
UMLS CUI [2]
C0155616
6. pregnant women
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
7. clinically relevant allergic symptoms or past history of hypersensitivity to drugs /
Beschreibung

Drug Allergy

Datentyp

boolean

Alias
UMLS CUI [1]
C0013182
significant adverse drug reactions
Beschreibung

Adverse reaction to drug

Datentyp

boolean

Alias
UMLS CUI [1]
C0041755
8. extremely poor bile secretion or serious liver disorders
Beschreibung

Deficiency of bile secretion | Liver diseases Serious

Datentyp

boolean

Alias
UMLS CUI [1]
C3203690
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205404
9. treatment-required malignant tumors
Beschreibung

Malignant Neoplasms Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332121
10. patients who are judged by the physician in charge to be ineligible for the study for any other reasons
Beschreibung

Study Subject Participation Status Ineligible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Hypertension NCT01075698

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Outpatients
Item
1. outpatients
boolean
C0029921 (UMLS CUI [1])
Age
Item
2. age: ≥ 40 to < 80
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure
Item
3. hypertension: systolic blood pressure of ≥ 140 mmhg or diastolic blood pressure of ≥
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Sitting blood pressure | Systolic Pressure | Diastolic blood pressure | Requirement Antihypertensive therapy
Item
90 mmhg in the two latest measurements of casual blood pressure (in the sitting position) regardless of treated or untreated condition, or systolic blood pressure of < 140 mmhg and diastolic blood pressure of < 90 mmhg that require antihypertensive treatment.
boolean
C0580946 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C1514873 (UMLS CUI [4,1])
C0585941 (UMLS CUI [4,2])
Assessment Hypertensive disease | Blood pressure determination | Average Measurement Quantity
Item
assessment of hypertension: blood pressure will be measured at least twice at an interval of 1 to 2 minutes. if the measured values obtained are substantially different, additional measurements will be performed and the average of two stable measurements will be used for assessment.
boolean
C1516048 (UMLS CUI [1,1])
C0020538 (UMLS CUI [1,2])
C0005824 (UMLS CUI [2])
C1510992 (UMLS CUI [3,1])
C0242485 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Informed Consent
Item
4. patients who have given consent to participate in the present study.
boolean
C0021430 (UMLS CUI [1])
Cardiovascular risk
Item
cardiovascular risks:
boolean
C4324389 (UMLS CUI [1])
Diabetes Mellitus | Diabetes Mellitus, Non-Insulin-Dependent
Item
1. diabetes mellitus; type 2 diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Kidney | Creatinine measurement, serum | Gender | Proteinuria | Chronic kidney disease stage | Glomerular Filtration Rate
Item
2. kidney; serum creatinine: 1.2 mg/dl - < 2.0 mg/dl for males, 1.0 mg/dl - < 2.0 mg/dl for females proteinuria: qualitative value of ≥ +1 (quantitative value: proteinuria with the value of ≥ 0.3 g/g・cr in casual urine when adjusted with urine creatinine) ckd stage 3 or higher (gfr < 60 ml/min/1.73 m2)
boolean
C0022646 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0033687 (UMLS CUI [4])
C2074731 (UMLS CUI [5])
C0017654 (UMLS CUI [6])
Heart | Myocardial Infarction | Angina Pectoris | Heart failure New York Heart Association Classification | Left Ventricular Hypertrophy | Echocardiography for determining posterior left ventricular wall thickness | Atrial Fibrillation Transient | Persistent atrial fibrillation
Item
3. heart; previous myocardial infarction noted more than 6 months before obtaining the informed consent diagnosis of angina pectoris diagnosis of heart failure (nyha i or ii class) diagnosis of left ventricular hypertrophy (left ventricular posterior wall of ≥ 12 mm evidenced by echocardiography performed prior to obtaining the informed consent, or sv1+rv5 of ≥ 35 mm noted as ecg finding) diagnosis of transient or persisting atrial fibrillation
boolean
C0018787 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0149721 (UMLS CUI [5])
C0203366 (UMLS CUI [6])
C0004238 (UMLS CUI [7,1])
C0205374 (UMLS CUI [7,2])
C2585653 (UMLS CUI [8])
Brain | Cerebral Infarction | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Transient Ischemic Attack
Item
4. brain; previous cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient cerebral ischemic attack noted more than 6 months before obtaining the informed consent
boolean
C0006104 (UMLS CUI [1])
C0007785 (UMLS CUI [2])
C2937358 (UMLS CUI [3])
C0038525 (UMLS CUI [4])
C0007787 (UMLS CUI [5])
Peripheral Arterial Diseases | Peripheral artery bypass Lower limb | Angioplasty Lower limb | Ankle brachial pressure index | Intermittent Claudication
Item
5. peripheral arterial diseases; previous lower-limb bypass surgery or angioplasty performed more than 6 months before obtaining the informed consent ankle-brachial pressure index of < 0.9 or intermittent claudication
boolean
C1704436 (UMLS CUI [1])
C3495795 (UMLS CUI [2,1])
C0023216 (UMLS CUI [2,2])
C0162577 (UMLS CUI [3,1])
C0023216 (UMLS CUI [3,2])
C1276055 (UMLS CUI [4])
C0021775 (UMLS CUI [5])
Item Group
C0680251 (UMLS CUI)
Criteria Any Fulfill
Item
patients who meet any of the following criteria will be excluded from the study.
boolean
C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Diabetes Mellitus, Insulin-Dependent
Item
1. type 1 diabetes mellitus
boolean
C0011854 (UMLS CUI [1])
Kidney Diseases Severe | Creatinine measurement, serum
Item
2. severe renal disorders (serum creatinine of ≥ 2.0 mg/dl)
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Myocardial Infarction | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery | Blood vessel of lower limb Bypass | Cerebral Infarction | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Transient Ischemic Attack
Item
3. myocardial infarction, percutaneous transluminal angioplasty and bypass surgery of coronary artery/ lower-limb blood vessel, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage and transient cerebral ischemic attack noted within 6 months before initiation of the observation
boolean
C0027051 (UMLS CUI [1])
C2936173 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C4517177 (UMLS CUI [4,1])
C0741847 (UMLS CUI [4,2])
C0007785 (UMLS CUI [5])
C2937358 (UMLS CUI [6])
C0038525 (UMLS CUI [7])
C0007787 (UMLS CUI [8])
Heart failure New York Heart Association Classification
Item
4. diagnosis of heart failure (nyha iii or iv class )
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Malignant Hypertension | Secondary hypertension
Item
5. virulent hypertension and secondary hypertension
boolean
C0020540 (UMLS CUI [1])
C0155616 (UMLS CUI [2])
Pregnancy
Item
6. pregnant women
boolean
C0032961 (UMLS CUI [1])
Drug Allergy
Item
7. clinically relevant allergic symptoms or past history of hypersensitivity to drugs /
boolean
C0013182 (UMLS CUI [1])
Adverse reaction to drug
Item
significant adverse drug reactions
boolean
C0041755 (UMLS CUI [1])
Deficiency of bile secretion | Liver diseases Serious
Item
8. extremely poor bile secretion or serious liver disorders
boolean
C3203690 (UMLS CUI [1])
C0023895 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Malignant Neoplasms Treatment required for
Item
9. treatment-required malignant tumors
boolean
C0006826 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Study Subject Participation Status Ineligible
Item
10. patients who are judged by the physician in charge to be ineligible for the study for any other reasons
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video