ID

29960

Description

A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED); ODM derived from: https://clinicaltrials.gov/show/NCT00789321

Link

https://clinicaltrials.gov/show/NCT00789321

Keywords

Versions (2)
  1. 4/30/18 4/30/18 -
  2. 4/30/18 4/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 30, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Hypertension NCT00789321

English

Eligibility Hypertension NCT00789321

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient does not have hypertension or has stage i or ii hypertension and is taking < 3 anti-hypertension medications
Description

Hypertensive disease Absent | Hypertensive disease Stage | Antihypertensive Agents Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0699749
UMLS CUI [3,1]
C0003364
UMLS CUI [3,2]
C1265611
patient is willing to discontinue all anti-hypertensive medications during study
Description

Antihypertensive Agents Discontinue Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0600109
patient is willing to refrain from drinking alcohol for 24 hours prior to each study visit and is willing to limit intake at other times during the study to 2 drinks per day
Description

Avoidance Alcohol consumption | Alcohol consumption Alcoholic drinks per day

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0001948
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0001967
UMLS CUI [2,3]
C0439505
patient agrees to avoid caffeine for 24 hours prior to each study visit. at other times during study, daily caffeine intake should not exceed 4 cups of coffee (or equivalent)
Description

Avoidance Caffeine | Caffeine intake Cup Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C0006644
UMLS CUI [2,1]
C4062719
UMLS CUI [2,2]
C3853579
UMLS CUI [2,3]
C1265611
patient will avoid strenuous physical activity during study
Description

Avoidance Strenuous activity

Data type

boolean

Alias
UMLS CUI [1,1]
C0870186
UMLS CUI [1,2]
C1514989
patient is a nonsmoker or has not smoked for the last 3 months
Description

Non-smoker | Tobacco use Absent

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C0543414
UMLS CUI [2,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient has metal implants in the leg or artificial limbs
Description

Metallic implant Leg | Limb Prosthesis

Data type

boolean

Alias
UMLS CUI [1,1]
C3693688
UMLS CUI [1,2]
C1140621
UMLS CUI [2]
C0347948
patient has had a lower limb amputation, malformation, alterations in leg muscles, or a history of musculoskeletal disease
Description

Amputation of lower limb | Malformation | Alteration Leg muscles | Musculoskeletal Disease

Data type

boolean

Alias
UMLS CUI [1]
C0337308
UMLS CUI [2]
C0000768
UMLS CUI [3,1]
C1515926
UMLS CUI [3,2]
C0224456
UMLS CUI [4]
C0026857
patient has used oral contraceptive pills or hormone replacement therapy within 3 months of screening
Description

Contraceptives, Oral | Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0009905
UMLS CUI [2]
C0282402
patient has a history of stroke or seizures
Description

Cerebrovascular accident | Seizures

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0036572
patient has a history of cancer, except that which was treated at least 10 years prior to screening and shows no evidence of recurrence
Description

Malignant Neoplasms | Exception Cancer treatment Previous | Exception Recurrent disease Absent

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0920425
UMLS CUI [2,3]
C0205156
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0277556
UMLS CUI [3,3]
C0332197
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Similar models

Eligibility Hypertension NCT00789321

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease Absent | Hypertensive disease Stage | Antihypertensive Agents Quantity
Item
patient does not have hypertension or has stage i or ii hypertension and is taking < 3 anti-hypertension medications
boolean
C0020538 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2,1])
C0699749 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Antihypertensive Agents Discontinue Willing
Item
patient is willing to discontinue all anti-hypertensive medications during study
boolean
C0003364 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Avoidance Alcohol consumption | Alcohol consumption Alcoholic drinks per day
Item
patient is willing to refrain from drinking alcohol for 24 hours prior to each study visit and is willing to limit intake at other times during the study to 2 drinks per day
boolean
C0870186 (UMLS CUI [1,1])
C0001948 (UMLS CUI [1,2])
C0001948 (UMLS CUI [2,1])
C0001967 (UMLS CUI [2,2])
C0439505 (UMLS CUI [2,3])
Avoidance Caffeine | Caffeine intake Cup Quantity
Item
patient agrees to avoid caffeine for 24 hours prior to each study visit. at other times during study, daily caffeine intake should not exceed 4 cups of coffee (or equivalent)
boolean
C0870186 (UMLS CUI [1,1])
C0006644 (UMLS CUI [1,2])
C4062719 (UMLS CUI [2,1])
C3853579 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Avoidance Strenuous activity
Item
patient will avoid strenuous physical activity during study
boolean
C0870186 (UMLS CUI [1,1])
C1514989 (UMLS CUI [1,2])
Non-smoker | Tobacco use Absent
Item
patient is a nonsmoker or has not smoked for the last 3 months
boolean
C0337672 (UMLS CUI [1])
C0543414 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Metallic implant Leg | Limb Prosthesis
Item
patient has metal implants in the leg or artificial limbs
boolean
C3693688 (UMLS CUI [1,1])
C1140621 (UMLS CUI [1,2])
C0347948 (UMLS CUI [2])
Amputation of lower limb | Malformation | Alteration Leg muscles | Musculoskeletal Disease
Item
patient has had a lower limb amputation, malformation, alterations in leg muscles, or a history of musculoskeletal disease
boolean
C0337308 (UMLS CUI [1])
C0000768 (UMLS CUI [2])
C1515926 (UMLS CUI [3,1])
C0224456 (UMLS CUI [3,2])
C0026857 (UMLS CUI [4])
Contraceptives, Oral | Hormone replacement therapy
Item
patient has used oral contraceptive pills or hormone replacement therapy within 3 months of screening
boolean
C0009905 (UMLS CUI [1])
C0282402 (UMLS CUI [2])
Cerebrovascular accident | Seizures
Item
patient has a history of stroke or seizures
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2])
Malignant Neoplasms | Exception Cancer treatment Previous | Exception Recurrent disease Absent
Item
patient has a history of cancer, except that which was treated at least 10 years prior to screening and shows no evidence of recurrence
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
C0205156 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0277556 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
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