ID

39932

Description

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

Lien

https://clinicaltrials.gov/show/NCT01075698

Mots-clés

Versions (2)
  1. 04/03/2020 04/03/2020 -
  2. 05/03/2020 05/03/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 mars 2020

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 4.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Hypertension NCT01075698

Anglais

Eligibility Hypertension NCT01075698

1 Formulaires  
Criteria
Description

Criteria

1. outpatients
Description

Outpatients

Type de données

boolean

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

Age

Type de données

boolean

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

Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Type de données

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.
Description

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

Type de données

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.
Description

Assessment Hypertensive disease | Blood pressure determination | Average Measurement Quantity

Type de données

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.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
cardiovascular risks:
Description

Cardiovascular risk

Type de données

boolean

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

Diabetes Mellitus | Diabetes Mellitus, Non-Insulin-Dependent

Type de données

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)
Description

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

Type de données

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
Description

Heart | Myocardial Infarction | Angina Pectoris | Heart failure New York Heart Association Classification | Left Ventricular Hypertrophy | Atrial Fibrillation Transient | Persistent atrial fibrillation

Type de données

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 [6,1]
C0004238
UMLS CUI [6,2]
C0205374
UMLS CUI [7]
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
Description

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

Type de données

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
Description

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

Type de données

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
Description

Exclusion Criteria

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

Criteria Any Fulfill

Type de données

boolean

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

Diabetes Mellitus, Insulin-Dependent

Type de données

boolean

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

Kidney Diseases Severe

Type de données

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
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
Description

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

Type de données

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 )
Description

Heart failure New York Heart Association Classification

Type de données

boolean

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

Other Coding | Secondary hypertension

Type de données

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2]
C0155616
6. pregnant women
Description

Pregnancy

Type de données

boolean

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

Drug Allergy

Type de données

boolean

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

Adverse reaction to drug

Type de données

boolean

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

Deficiency of bile secretion | Liver diseases Serious

Type de données

boolean

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

Malignant Neoplasms Treatment required for

Type de données

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
Description

Study Subject Participation Status Ineligible

Type de données

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
Retour au début de la page

Similar models

Eligibility Hypertension NCT01075698

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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 | 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])
C0004238 (UMLS CUI [6,1])
C0205374 (UMLS CUI [6,2])
C2585653 (UMLS CUI [7])
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
Item
2. severe renal disorders (serum creatinine of ≥ 2.0 mg/dl)
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
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])
Other Coding | Secondary hypertension
Item
5. virulent hypertension and secondary hypertension
boolean
C3846158 (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])
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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