ID

36126

Beskrivning

Telmisartan and Hydrochlorothiazide Antihypertensive Treatment Study in High Sodium Intake Population; ODM derived from: https://clinicaltrials.gov/show/NCT02255253

Länk

https://clinicaltrials.gov/show/NCT02255253

Nyckelord

Versioner (1)
  1. 2019-04-16 2019-04-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 april 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT02255253

Engelsk

Eligibility Hypertension NCT02255253

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age≥18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
essential hypertension: systolic blood pressure (sbp) is between 140mmhg-179mmhg and diastolic blood pressure (dbp)＜110mmhg or dbp is between 90mmhg-109mmhg and sbp＜180mmhg.
Beskrivning

Essential Hypertension | Systolic Pressure | Diastolic blood pressure

Datatyp

boolean

Alias
UMLS CUI [1]
C0085580
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
hypertension patients diagnosed by spot urine test (urine sodium≥200mmol/24h).
Beskrivning

Hypertensive disease | Spot test Urine | 24 hour urine sodium measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2,1]
C0201812
UMLS CUI [2,2]
C0042036
UMLS CUI [3]
C1278233
subjects are not using antihypertensive medicines or medicines which affect the blood pressure within a week.
Beskrivning

Antihypertensive Agents Absent | Absence Pharmaceutical Preparations Affecting Blood Pressure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0005823
subjects volunteer to be brought in the research and have signed informed consent form, given that they have understood the research content.
Beskrivning

Study Subject Research | Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0035168
UMLS CUI [2]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
females who are already pregnant, in lactation and intend to be pregnant.
Beskrivning

Pregnancy | Breast Feeding | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
patients who have seriously allergic reaction or angioneurotic edema when taking arb; patients who have allergic history of thiazide diuretic (hctz) or sulfonamides.
Beskrivning

Allergic Reaction Serious Angiotensin II receptor antagonist | Angioedema Due to Angiotensin II receptor antagonist | Thiazide diuretic allergy | Allergy to sulfonamides

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521942
UMLS CUI [2,1]
C0002994
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0521942
UMLS CUI [3]
C0571894
UMLS CUI [4]
C0038757
patients who do not want to stop or have to take the medicines which are also antihypertensive or affect the blood pressure, other than which provided by the research.
Beskrivning

Antihypertensive Agents To be stopped Unwilling | Patient need for Antihypertensive Agents | Antihypertensive Agents Affecting Blood Pressure | Exception Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1272691
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0003364
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0005823
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0013230
stroke or chd patients who are diagnosed within 6 months. chd patients are identified by being diagnosed by coronary arteriography or coronary ct angiography, having received coronary stent or coronary artery bypass surgery, or being diagnosed with acute myocardial infarction. stroke patients are identified by being diagnosed with cerebral thrombosis, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack.
Beskrivning

Cerebrovascular accident | Coronary heart disease | Coronary arteriography | CT angiography of coronary arteries | Placement of stent in coronary artery | Coronary Artery Bypass Surgery | Myocardial Infarction | Cerebral Thrombosis | Cerebral Embolism | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0010068
UMLS CUI [3]
C0085532
UMLS CUI [4]
C1634617
UMLS CUI [5]
C0521232
UMLS CUI [6]
C0010055
UMLS CUI [7]
C0027051
UMLS CUI [8]
C0079102
UMLS CUI [9]
C0007780
UMLS CUI [10]
C2937358
UMLS CUI [11]
C0038525
UMLS CUI [12]
C0007787
patients who are clearly diagnosed with following diseases: congenital disease, myocardiopathy, serious arrhythmia, pulmonary heart disease, various of cardiac failure.
Beskrivning

Congenital Disorders | Cardiomyopathy | Cardiac Arrhythmia Serious | Cor pulmonale | Heart failure

Datatyp

boolean

Alias
UMLS CUI [1]
C0242354
UMLS CUI [2]
C0878544
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0034072
UMLS CUI [5]
C0018801
patients who are clearly diagnosed with following symptoms or diseases: proteinuria or heavy proteinuria, renal insufficiency or serious renal function damage, hepatic insufficiency or serious hepatic function damage; retinal exudates or hemorrhage, or papilledema.
Beskrivning

Symptoms | Disease | Proteinuria | Heavy proteinuria | Renal Insufficiency | Renal function Impairment Serious | Hepatic Insufficiency | Liver function Impairment Serious | Retinal exudates | Retinal Hemorrhage | Papilledema

Datatyp

boolean

Alias
UMLS CUI [1]
C1457887
UMLS CUI [2]
C0012634
UMLS CUI [3]
C0033687
UMLS CUI [4]
C4022830
UMLS CUI [5]
C1565489
UMLS CUI [6,1]
C0232804
UMLS CUI [6,2]
C0221099
UMLS CUI [6,3]
C0205404
UMLS CUI [7]
C1306571
UMLS CUI [8,1]
C0232741
UMLS CUI [8,2]
C0221099
UMLS CUI [8,3]
C0205404
UMLS CUI [9]
C0240897
UMLS CUI [10]
C0035317
UMLS CUI [11]
C0030353
patients who are clearly diagnosed with serious or deadly diseases in other systems.
Beskrivning

Disease Serious | Disease Fatal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C1302234
patients who get dementia or other serious diseases cannot cooperate with researchers.
Beskrivning

Dementia | Disease Serious | Cooperation Research Personnel Unable

Datatyp

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0392337
UMLS CUI [3,2]
C0035173
UMLS CUI [3,3]
C1299582
patients who drink 200g white spirits per day in past week.
Beskrivning

Alcohol consumption Spirits U/day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0301611
UMLS CUI [1,3]
C0456683
patients who meet other situations which are considered to be inappropriate to be enrolled into the study by researchers.
Beskrivning

Social situation Study Subject Participation Status Inappropriate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0748872
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
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Similar models

Eligibility Hypertension NCT02255253

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age≥18
boolean
C0001779 (UMLS CUI [1])
Essential Hypertension | Systolic Pressure | Diastolic blood pressure
Item
essential hypertension: systolic blood pressure (sbp) is between 140mmhg-179mmhg and diastolic blood pressure (dbp)＜110mmhg or dbp is between 90mmhg-109mmhg and sbp＜180mmhg.
boolean
C0085580 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Hypertensive disease | Spot test Urine | 24 hour urine sodium measurement
Item
hypertension patients diagnosed by spot urine test (urine sodium≥200mmol/24h).
boolean
C0020538 (UMLS CUI [1])
C0201812 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
C1278233 (UMLS CUI [3])
Antihypertensive Agents Absent | Absence Pharmaceutical Preparations Affecting Blood Pressure
Item
subjects are not using antihypertensive medicines or medicines which affect the blood pressure within a week.
boolean
C0003364 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0005823 (UMLS CUI [2,4])
Study Subject Research | Informed Consent
Item
subjects volunteer to be brought in the research and have signed informed consent form, given that they have understood the research content.
boolean
C0681850 (UMLS CUI [1,1])
C0035168 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
females who are already pregnant, in lactation and intend to be pregnant.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Allergic Reaction Serious Angiotensin II receptor antagonist | Angioedema Due to Angiotensin II receptor antagonist | Thiazide diuretic allergy | Allergy to sulfonamides
Item
patients who have seriously allergic reaction or angioneurotic edema when taking arb; patients who have allergic history of thiazide diuretic (hctz) or sulfonamides.
boolean
C1527304 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521942 (UMLS CUI [1,3])
C0002994 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0521942 (UMLS CUI [2,3])
C0571894 (UMLS CUI [3])
C0038757 (UMLS CUI [4])
Antihypertensive Agents To be stopped Unwilling | Patient need for Antihypertensive Agents | Antihypertensive Agents Affecting Blood Pressure | Exception Investigational New Drugs
Item
patients who do not want to stop or have to take the medicines which are also antihypertensive or affect the blood pressure, other than which provided by the research.
boolean
C0003364 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0686904 (UMLS CUI [2,1])
C0003364 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0005823 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
Cerebrovascular accident | Coronary heart disease | Coronary arteriography | CT angiography of coronary arteries | Placement of stent in coronary artery | Coronary Artery Bypass Surgery | Myocardial Infarction | Cerebral Thrombosis | Cerebral Embolism | Cerebral Hemorrhage | Subarachnoid Hemorrhage | Transient Ischemic Attack
Item
stroke or chd patients who are diagnosed within 6 months. chd patients are identified by being diagnosed by coronary arteriography or coronary ct angiography, having received coronary stent or coronary artery bypass surgery, or being diagnosed with acute myocardial infarction. stroke patients are identified by being diagnosed with cerebral thrombosis, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack.
boolean
C0038454 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C0085532 (UMLS CUI [3])
C1634617 (UMLS CUI [4])
C0521232 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
C0079102 (UMLS CUI [8])
C0007780 (UMLS CUI [9])
C2937358 (UMLS CUI [10])
C0038525 (UMLS CUI [11])
C0007787 (UMLS CUI [12])
Congenital Disorders | Cardiomyopathy | Cardiac Arrhythmia Serious | Cor pulmonale | Heart failure
Item
patients who are clearly diagnosed with following diseases: congenital disease, myocardiopathy, serious arrhythmia, pulmonary heart disease, various of cardiac failure.
boolean
C0242354 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0003811 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0034072 (UMLS CUI [4])
C0018801 (UMLS CUI [5])
Symptoms | Disease | Proteinuria | Heavy proteinuria | Renal Insufficiency | Renal function Impairment Serious | Hepatic Insufficiency | Liver function Impairment Serious | Retinal exudates | Retinal Hemorrhage | Papilledema
Item
patients who are clearly diagnosed with following symptoms or diseases: proteinuria or heavy proteinuria, renal insufficiency or serious renal function damage, hepatic insufficiency or serious hepatic function damage; retinal exudates or hemorrhage, or papilledema.
boolean
C1457887 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
C0033687 (UMLS CUI [3])
C4022830 (UMLS CUI [4])
C1565489 (UMLS CUI [5])
C0232804 (UMLS CUI [6,1])
C0221099 (UMLS CUI [6,2])
C0205404 (UMLS CUI [6,3])
C1306571 (UMLS CUI [7])
C0232741 (UMLS CUI [8,1])
C0221099 (UMLS CUI [8,2])
C0205404 (UMLS CUI [8,3])
C0240897 (UMLS CUI [9])
C0035317 (UMLS CUI [10])
C0030353 (UMLS CUI [11])
Disease Serious | Disease Fatal
Item
patients who are clearly diagnosed with serious or deadly diseases in other systems.
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C1302234 (UMLS CUI [2,2])
Dementia | Disease Serious | Cooperation Research Personnel Unable
Item
patients who get dementia or other serious diseases cannot cooperate with researchers.
boolean
C0497327 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0392337 (UMLS CUI [3,1])
C0035173 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Alcohol consumption Spirits U/day
Item
patients who drink 200g white spirits per day in past week.
boolean
C0001948 (UMLS CUI [1,1])
C0301611 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Social situation Study Subject Participation Status Inappropriate
Item
patients who meet other situations which are considered to be inappropriate to be enrolled into the study by researchers.
boolean
C0748872 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
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