ID

40340

Beskrivning

The Role of Gut Microbiota in Hypertension; ODM derived from: https://clinicaltrials.gov/show/NCT02188381

Länk

https://clinicaltrials.gov/show/NCT02188381

Nyckelord

Versioner (1)
  1. 2020-04-09 2020-04-09 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

9 april 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT02188381

Engelsk

Eligibility Hypertension NCT02188381

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age >18 and <80
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
is competent and willing to provide consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
inclusion criteria for each subject group:
Beskrivning

Study Subject Group Each

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0441833
UMLS CUI [1,3]
C1457900
control subjects will have a systolic bp <140mmhg with no cardiovascular disease
Beskrivning

Control Groups | Systolic Pressure | Cardiovascular Disease Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0009932
UMLS CUI [2]
C0871470
UMLS CUI [3,1]
C0007222
UMLS CUI [3,2]
C0332197
patients with controlled hypertension
Beskrivning

Hypertensive disease Controlled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C2911690
resistant hypertension subjects will have systolic blood pressure (bp) ≥140 mmhg despite ≥3 anti-hypertensive medications of different classes
Beskrivning

HYPERTENSION RESISTANT | Systolic Pressure | Antihypertensive Agents Quantity | Antihypertensive Agents Class Different

Datatyp

boolean

Alias
UMLS CUI [1]
C0745130
UMLS CUI [2]
C0871470
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0003364
UMLS CUI [4,2]
C0456387
UMLS CUI [4,3]
C1705242
subjects participating in nct 02133872 will be eligible to participate
Beskrivning

Study Subject Participation Status | Clinical Trial Specified

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
currently pregnant or have been pregnant in the last 6 months;
Beskrivning

Pregnancy | Pregnancy Recent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332185
antibiotic treatment within 2 months of study enrollment;
Beskrivning

Antibiotic therapy Recent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338237
UMLS CUI [1,2]
C0332185
currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications);
Beskrivning

Antibiotics | Anti-Inflammatory Agents | Glucocorticoids | Biological Response Modifiers

Datatyp

boolean

Alias
UMLS CUI [1]
C0003232
UMLS CUI [2]
C0003209
UMLS CUI [3]
C0017710
UMLS CUI [4]
C0005525
unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection);
Beskrivning

Vitamins Discontinue Unwilling | Supplements Discontinue Unwilling | Probiotics Discontinue Unwilling | Vitamins Affecting Intestinal Microbiome | Supplements Affecting Intestinal Microbiome | Probiotics Affecting Intestinal Microbiome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042890
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0525033
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C0558080
UMLS CUI [4,1]
C0042890
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C2985398
UMLS CUI [5,1]
C0242295
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C2985398
UMLS CUI [6,1]
C0525033
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C2985398
history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
Beskrivning

Intestinal surgery | Inflammatory Bowel Disease | Celiac Disease | Lactose Intolerance | Pancreatitis, Chronic | Malabsorption Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C2064958
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0007570
UMLS CUI [4]
C0022951
UMLS CUI [5]
C0149521
UMLS CUI [6]
C0024523
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Similar models

Eligibility Hypertension NCT02188381

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age >18 and <80
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
is competent and willing to provide consent
boolean
C0021430 (UMLS CUI [1])
Study Subject Group Each
Item
inclusion criteria for each subject group:
boolean
C0681850 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
C1457900 (UMLS CUI [1,3])
Control Groups | Systolic Pressure | Cardiovascular Disease Absent
Item
control subjects will have a systolic bp <140mmhg with no cardiovascular disease
boolean
C0009932 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0007222 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Hypertensive disease Controlled
Item
patients with controlled hypertension
boolean
C0020538 (UMLS CUI [1,1])
C2911690 (UMLS CUI [1,2])
HYPERTENSION RESISTANT | Systolic Pressure | Antihypertensive Agents Quantity | Antihypertensive Agents Class Different
Item
resistant hypertension subjects will have systolic blood pressure (bp) ≥140 mmhg despite ≥3 anti-hypertensive medications of different classes
boolean
C0745130 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0003364 (UMLS CUI [4,1])
C0456387 (UMLS CUI [4,2])
C1705242 (UMLS CUI [4,3])
Study Subject Participation Status | Clinical Trial Specified
Item
subjects participating in nct 02133872 will be eligible to participate
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy Recent
Item
currently pregnant or have been pregnant in the last 6 months;
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Antibiotic therapy Recent
Item
antibiotic treatment within 2 months of study enrollment;
boolean
C0338237 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Antibiotics | Anti-Inflammatory Agents | Glucocorticoids | Biological Response Modifiers
Item
currently taking a medication (e.g., antibiotic, anti-inflammatory agents, glucocorticoids or other immune modulating medications);
boolean
C0003232 (UMLS CUI [1])
C0003209 (UMLS CUI [2])
C0017710 (UMLS CUI [3])
C0005525 (UMLS CUI [4])
Vitamins Discontinue Unwilling | Supplements Discontinue Unwilling | Probiotics Discontinue Unwilling | Vitamins Affecting Intestinal Microbiome | Supplements Affecting Intestinal Microbiome | Probiotics Affecting Intestinal Microbiome
Item
unwilling to discontinue vitamin or supplements, including probiotics, potentially affecting gut microbiota (vitamins/supplements and medications that possibly affect the gut microbiota should be discontinued for at least 2wks prior to stool collection);
boolean
C0042890 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0525033 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0042890 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C2985398 (UMLS CUI [4,3])
C0242295 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C2985398 (UMLS CUI [5,3])
C0525033 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C2985398 (UMLS CUI [6,3])
Intestinal surgery | Inflammatory Bowel Disease | Celiac Disease | Lactose Intolerance | Pancreatitis, Chronic | Malabsorption Syndrome
Item
history of intestinal surgery, inflammatory bowel disease, celiac disease, lactose intolerance, chronic pancreatitis or other malabsorption disorder.
boolean
C2064958 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0007570 (UMLS CUI [3])
C0022951 (UMLS CUI [4])
C0149521 (UMLS CUI [5])
C0024523 (UMLS CUI [6])
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