ID

28929

Descrizione

Prevention of Diabetes and Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT00456963

collegamento

https://clinicaltrials.gov/show/NCT00456963

Keywords

versioni (1)
  1. 17/02/18 17/02/18 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

17 febbraio 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Diabetes Mellitus NCT00456963

Inglese

Eligibility Diabetes Mellitus NCT00456963

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
men or women of any racial background
Descrizione

Racial group Any

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C1552551
age >= 40 years and <= 75 years
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
sbp>= 130 mmhg and < 140 mmhg or dbp >= 85 mmhg and < 90 mmhg, average of screening and randomisation visits (in absence of any antihypertensive medication)
Descrizione

Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Absent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C0332197
fg >=100 mg/dl (5.6 mmol/l) and < 126 mg/dl (7.0 mmol/l) between screening and randomisation (in absence of any antidiabetic medication)
Descrizione

Glucose measurement, fasting | Antidiabetics Absent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0202045
UMLS CUI [2,1]
C0935929
UMLS CUI [2,2]
C0332197
waist circumference >= 102 cm in men and >= 88 cm in women.
Descrizione

Waist Circumference | Gender

Tipo di dati

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
sbp >= 140 mmhg or dbp >= 90 mmhg
Descrizione

Systolic Pressure | Diastolic blood pressure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation
Descrizione

Antihypertensive Agents | Antidiabetics | Anti-Obesity Agents

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2]
C0935929
UMLS CUI [3]
C0376607
any current or previous cardiovascular or renal disease requiring continuous administration of ds, ßbs, aceis, arbs, cas, and any other antihypertensive medication
Descrizione

Cardiovascular Diseases | Kidney Diseases | Requirement Adrenergic beta-1 Receptor Antagonists | Requirement Angiotensin-Converting Enzyme Inhibitors | Requirement Angiotensin II receptor antagonistantagonist | Requirement Antihypertensive Agents

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0022658
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0304516
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0003015
UMLS CUI [5,1]
C1514873
UMLS CUI [5,2]
C0521942
UMLS CUI [6,1]
C1514873
UMLS CUI [6,2]
C0003364
any medical condition preventing adherence to lifestyle measures included in the protocol
Descrizione

Medical condition Preventing Adherence Lifestyle Therapy

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1510802
UMLS CUI [1,4]
C1517876
hepatic disease as ast (sgot) or alt (sgpt) values equal or greater than two times the upper limit of normal
Descrizione

Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
chronic renal dysfunction as serum creatinine > 2.0 mg/dl
Descrizione

Renal dysfunction chronic | Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0201976
any gastrointestinal disorder interfering with drug absorption
Descrizione

Gastrointestinal Disease Interferes with Drug absorption

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0678745
known allergy or contraindications to aceis or arbs
Descrizione

Angiotensin-converting-enzyme inhibitor allergy | Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Allergy to angiotensin II receptor antagonist | Medical contraindication Angiotensin II receptor antagonist

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0571939
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0003015
UMLS CUI [3]
C2585204
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C0521942
pregnant or lactating women; women in reproductive age not using recognized contraceptive methods
Descrizione

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332268
malignancy within the last 5 years
Descrizione

Malignant Neoplasms

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
clinically significant autoimmune disorders
Descrizione

Autoimmune Diseases

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004364
drug abuse or alcohol abuse within the last 5 years
Descrizione

Substance Use Disorders

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0038586
history of noncompliance to medical regimens
Descrizione

Protocol Compliance Lacking

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0332268
incapacity or unwillingness to sign the informed consent
Descrizione

Informed Consent Unable | Informed Consent Unwilling

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
participation in any investigational clinical trial within the last 3 months
Descrizione

Study Subject Participation Status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
Ritorna all'inizio della pagina

Similar models

Eligibility Diabetes Mellitus NCT00456963

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Racial group Any
Item
men or women of any racial background
boolean
C0034510 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Age
Item
age >= 40 years and <= 75 years
boolean
C0001779 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure | Antihypertensive Agents Absent
Item
sbp>= 130 mmhg and < 140 mmhg or dbp >= 85 mmhg and < 90 mmhg, average of screening and randomisation visits (in absence of any antihypertensive medication)
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Glucose measurement, fasting | Antidiabetics Absent
Item
fg >=100 mg/dl (5.6 mmol/l) and < 126 mg/dl (7.0 mmol/l) between screening and randomisation (in absence of any antidiabetic medication)
boolean
C0202045 (UMLS CUI [1])
C0935929 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Waist Circumference | Gender
Item
waist circumference >= 102 cm in men and >= 88 cm in women.
boolean
C0455829 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Systolic Pressure | Diastolic blood pressure
Item
sbp >= 140 mmhg or dbp >= 90 mmhg
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Antihypertensive Agents | Antidiabetics | Anti-Obesity Agents
Item
any antihypertensive, antidiabetic or antiobesity medication at the time of or during the 6 months previous to randomisation
boolean
C0003364 (UMLS CUI [1])
C0935929 (UMLS CUI [2])
C0376607 (UMLS CUI [3])
Cardiovascular Diseases | Kidney Diseases | Requirement Adrenergic beta-1 Receptor Antagonists | Requirement Angiotensin-Converting Enzyme Inhibitors | Requirement Angiotensin II receptor antagonistantagonist | Requirement Antihypertensive Agents
Item
any current or previous cardiovascular or renal disease requiring continuous administration of ds, ßbs, aceis, arbs, cas, and any other antihypertensive medication
boolean
C0007222 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0304516 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0003015 (UMLS CUI [4,2])
C1514873 (UMLS CUI [5,1])
C0521942 (UMLS CUI [5,2])
C1514873 (UMLS CUI [6,1])
C0003364 (UMLS CUI [6,2])
Medical condition Preventing Adherence Lifestyle Therapy
Item
any medical condition preventing adherence to lifestyle measures included in the protocol
boolean
C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1510802 (UMLS CUI [1,3])
C1517876 (UMLS CUI [1,4])
Liver diseases | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
hepatic disease as ast (sgot) or alt (sgpt) values equal or greater than two times the upper limit of normal
boolean
C0023895 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Renal dysfunction chronic | Creatinine measurement, serum
Item
chronic renal dysfunction as serum creatinine > 2.0 mg/dl
boolean
C3279454 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0201976 (UMLS CUI [2])
Gastrointestinal Disease Interferes with Drug absorption
Item
any gastrointestinal disorder interfering with drug absorption
boolean
C0017178 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
Angiotensin-converting-enzyme inhibitor allergy | Medical contraindication Angiotensin-Converting Enzyme Inhibitors | Allergy to angiotensin II receptor antagonist | Medical contraindication Angiotensin II receptor antagonist
Item
known allergy or contraindications to aceis or arbs
boolean
C0571939 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0003015 (UMLS CUI [2,2])
C2585204 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0521942 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Lacking
Item
pregnant or lactating women; women in reproductive age not using recognized contraceptive methods
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332268 (UMLS CUI [3,3])
Malignant Neoplasms
Item
malignancy within the last 5 years
boolean
C0006826 (UMLS CUI [1])
Autoimmune Diseases
Item
clinically significant autoimmune disorders
boolean
C0004364 (UMLS CUI [1])
Substance Use Disorders
Item
drug abuse or alcohol abuse within the last 5 years
boolean
C0038586 (UMLS CUI [1])
Protocol Compliance Lacking
Item
history of noncompliance to medical regimens
boolean
C0525058 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Informed Consent Unable | Informed Consent Unwilling
Item
incapacity or unwillingness to sign the informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Study Subject Participation Status
Item
participation in any investigational clinical trial within the last 3 months
boolean
C2348568 (UMLS CUI [1])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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