ID

36379

Descrição

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

Link

https://clinicaltrials.gov/show/NCT02517697

Palavras-chave

Versões (1)
  1. 08/05/2019 08/05/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

8 de maio de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Metabolic Syndrome NCT02517697

Inglês

Eligibility Metabolic Syndrome NCT02517697

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 18-60 years
Descrição

Age

Tipo de dados

boolean

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

Body mass index

Tipo de dados

boolean

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

Hypertensive disease | Systolic Pressure | Diastolic blood pressure

Tipo de dados

boolean

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

ID.4

Tipo de dados

boolean

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

Waist Circumference | Gender

Tipo de dados

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
positive urine pregnancy test or breastfeeding
Descrição

Urine pregnancy test positive | Breast Feeding

Tipo de dados

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)
Descrição

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

Tipo de dados

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)
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Phosphodiesterase 5 inhibitor | Nitrates organic

Tipo de dados

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.
Descrição

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

Tipo de dados

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
Descrição

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

Tipo de dados

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
Descrição

Thyroid stimulating hormone measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0202230
smoker
Descrição

Tobacco use

Tipo de dados

boolean

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

Anemia | Hemoglobin measurement

Tipo de dados

boolean

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

Periodontal Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0031090
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Similar models

Eligibility Metabolic Syndrome NCT02517697

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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