ID

36379

Beschreibung

Oral Nitrite Placebo Controlled Trial for Hypertension and Metabolic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT02517697

Link

https://clinicaltrials.gov/show/NCT02517697

Stichworte

Versionen (1)
  1. 08.05.19 08.05.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Mai 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Metabolic Syndrome NCT02517697

Englisch

Eligibility Metabolic Syndrome NCT02517697

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-60 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
bmi ≥ 30 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
hypertension: defined as systolic blood pressure ≥130 and/or diastolic blood pressure
Beschreibung

Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
≥85 mm hg
Beschreibung

ID.4

Datentyp

boolean

waist circumference: >102 cm in men, >88 cm in women
Beschreibung

Waist Circumference | Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0455829
UMLS CUI [2]
C0079399
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive urine pregnancy test or breastfeeding
Beschreibung

Urine pregnancy test positive | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0430059
UMLS CUI [2]
C0006147
concurrent use of medications affecting glucose or lipid metabolism (oral hypoglycemics, insulin, statins, atypical antipsychotics)
Beschreibung

Pharmaceutical Preparations Affecting Glucose metabolism | Pharmaceutical Preparations Affecting Lipid Metabolism | Oral hypoglycemic | Insulin | Statins | Atypical antipsychotic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0596620
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0598783
UMLS CUI [3]
C0359086
UMLS CUI [4]
C0021641
UMLS CUI [5]
C0360714
UMLS CUI [6]
C1276996
recent addition or change in dosing of hormonal contraceptive medications (ocp, iud, depoprovera)
Beschreibung

Oral Hormonal Contraceptives Dosage Addition | Oral Hormonal Contraceptives Change in drug dosage | Contraceptives, Oral | Intrauterine Devices | Depo-Provera

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009907
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0332287
UMLS CUI [2,1]
C0009907
UMLS CUI [2,2]
C0420247
UMLS CUI [3]
C0009905
UMLS CUI [4]
C0021900
UMLS CUI [5]
C0699700
current use of ≥2 anti-hypertensive agents regardless of blood pressure control or normotensive on a single agent
Beschreibung

Antihypertensive Agents Quantity | Independent of Control of blood pressure | Antihypertensive Agent Single Normal blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C1753303
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0205171
UMLS CUI [3,3]
C2712122
current use of pd5 inhibitors or organic nitrates
Beschreibung

Phosphodiesterase 5 inhibitor | Nitrates organic

Datentyp

boolean

Alias
UMLS CUI [1]
C1318700
UMLS CUI [2,1]
C0028125
UMLS CUI [2,2]
C0747055
not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc.
Beschreibung

Therapeutic procedure Unstable | Medication dose Changing Blood Pressure | Medication dose Changing Contraception

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C3174092
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0005823
UMLS CUI [3,1]
C3174092
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0700589
known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes
Beschreibung

Chronic mental disorder | Chronic disease | Diabetes Mellitus chronic | Chronic liver disease | Chronic Kidney Diseases | Obesity chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0870281
UMLS CUI [2]
C0008679
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C0205191
UMLS CUI [4]
C0341439
UMLS CUI [5]
C1561643
UMLS CUI [6,1]
C0028754
UMLS CUI [6,2]
C0205191
tsh >8 miu/ml
Beschreibung

Thyroid stimulating hormone measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0202230
smoker
Beschreibung

Tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
anemia (central lab hemoglobin < 11g/dl)
Beschreibung

Anemia | Hemoglobin measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
active periodontal disease
Beschreibung

Periodontal Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0031090
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Ähnliche Modelle

Eligibility Metabolic Syndrome NCT02517697

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 18-60 years
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
bmi ≥ 30 kg/m2
boolean
C1305855 (UMLS CUI [1])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure
Item
hypertension: defined as systolic blood pressure ≥130 and/or diastolic blood pressure
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
ID.4
Item
≥85 mm hg
boolean
Waist Circumference | Gender
Item
waist circumference: >102 cm in men, >88 cm in women
boolean
C0455829 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Urine pregnancy test positive | Breast Feeding
Item
positive urine pregnancy test or breastfeeding
boolean
C0430059 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Affecting Glucose metabolism | Pharmaceutical Preparations Affecting Lipid Metabolism | Oral hypoglycemic | Insulin | Statins | Atypical antipsychotic
Item
concurrent use of medications affecting glucose or lipid metabolism (oral hypoglycemics, insulin, statins, atypical antipsychotics)
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0598783 (UMLS CUI [2,3])
C0359086 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
C0360714 (UMLS CUI [5])
C1276996 (UMLS CUI [6])
Oral Hormonal Contraceptives Dosage Addition | Oral Hormonal Contraceptives Change in drug dosage | Contraceptives, Oral | Intrauterine Devices | Depo-Provera
Item
recent addition or change in dosing of hormonal contraceptive medications (ocp, iud, depoprovera)
boolean
C0009907 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0332287 (UMLS CUI [1,3])
C0009907 (UMLS CUI [2,1])
C0420247 (UMLS CUI [2,2])
C0009905 (UMLS CUI [3])
C0021900 (UMLS CUI [4])
C0699700 (UMLS CUI [5])
Antihypertensive Agents Quantity | Independent of Control of blood pressure | Antihypertensive Agent Single Normal blood pressure
Item
current use of ≥2 anti-hypertensive agents regardless of blood pressure control or normotensive on a single agent
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0332291 (UMLS CUI [2,1])
C1753303 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
C2712122 (UMLS CUI [3,3])
Phosphodiesterase 5 inhibitor | Nitrates organic
Item
current use of pd5 inhibitors or organic nitrates
boolean
C1318700 (UMLS CUI [1])
C0028125 (UMLS CUI [2,1])
C0747055 (UMLS CUI [2,2])
Therapeutic procedure Unstable | Medication dose Changing Blood Pressure | Medication dose Changing Contraception
Item
not stable on treatments for the prior three months or not planning to remain on current dose of medications for blood pressure, contraception, etc.
boolean
C0087111 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C3174092 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0005823 (UMLS CUI [2,3])
C3174092 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Chronic mental disorder | Chronic disease | Diabetes Mellitus chronic | Chronic liver disease | Chronic Kidney Diseases | Obesity chronic
Item
known chronic psychiatric or medical conditions including diabetes, liver or kidney disease or obesity syndromes
boolean
C0870281 (UMLS CUI [1])
C0008679 (UMLS CUI [2])
C0011849 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
C0341439 (UMLS CUI [4])
C1561643 (UMLS CUI [5])
C0028754 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
Thyroid stimulating hormone measurement
Item
tsh >8 miu/ml
boolean
C0202230 (UMLS CUI [1])
Tobacco use
Item
smoker
boolean
C0543414 (UMLS CUI [1])
Anemia | Hemoglobin measurement
Item
anemia (central lab hemoglobin < 11g/dl)
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Periodontal Disease
Item
active periodontal disease
boolean
C0031090 (UMLS CUI [1])
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