ID

40081

Descrição

Antihypertensive Effect and Safety of Peptides Derived From Coldwater Shrimp; ODM derived from: https://clinicaltrials.gov/show/NCT01583582

Link

https://clinicaltrials.gov/show/NCT01583582

Palavras-chave

Versões (1)
  1. 11/03/2020 11/03/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

11 de março de 2020

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Hypertension NCT01583582

Inglês

Eligibility Hypertension NCT01583582

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
mild or moderate hypertension (systolic blood pressure 130 - 160 mmhg and diastolic blood pressure ≤ 100 mmhg)
Descrição

Hypertension, mild | Hypertension, moderate | Systolic Pressure | Diastolic blood pressure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3276943
UMLS CUI [2]
C1969581
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
age 30 - 75 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
body weight ≥ 60 kg
Descrição

Body Weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
stable body weight
Descrição

Stable body weight

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0517386
use of effective contraception in women of childbearing potential
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
body mass index ≥ 35
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
antihypertensive drug treatment, regular high dose nsaid treatment and the use of cyclosporine or tacrolimus
Descrição

Antihypertensive therapy | NSAID High dose Regular | Cyclosporine | Tacrolimus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0585941
UMLS CUI [2,1]
C0003211
UMLS CUI [2,2]
C0444956
UMLS CUI [2,3]
C0205272
UMLS CUI [3]
C0010592
UMLS CUI [4]
C0085149
diabetes (type 1 and 2)
Descrição

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
anemia, abnormal electrolytes, proteinuria, abnormal liver, kidney and thyroid function, clinically significant biochemistry, any other clinically significant hematology and/or biochemistry at the investigator's discretion
Descrição

Anemia | Electrolytes abnormal | Proteinuria | Liver Dysfunction | Abnormal renal function | Thyroid function tests abnormal | Biochemical finding Clinical Significance | Hematology Clinical Significance

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0151613
UMLS CUI [3]
C0033687
UMLS CUI [4]
C0086565
UMLS CUI [5]
C0151746
UMLS CUI [6]
C0476414
UMLS CUI [7,1]
C0428132
UMLS CUI [7,2]
C2826293
UMLS CUI [8,1]
C0200627
UMLS CUI [8,2]
C2826293
cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack within six months prior to screening) including stroke and congestive heart failure
Descrição

Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Transient Ischemic Attack | Cerebrovascular accident | Congestive heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010055
UMLS CUI [5]
C2936173
UMLS CUI [6]
C0007787
UMLS CUI [7]
C0038454
UMLS CUI [8]
C0018802
secondary hypertension history of cancer or malignant disease within the past five years
Descrição

Secondary hypertension | History of cancer | Malignant disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0155616
UMLS CUI [2]
C0455471
UMLS CUI [3]
C0442867
any metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which in the investigator's opinion could interfere with the results of the study or the safety of the subjects
Descrição

Metabolic Disease | Gastrointestinal Disease | Disease Interferes with Research results | Disease Interferes with Patient safety

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0025517
UMLS CUI [2]
C0017178
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1113679
fish and other seafood allergies, citrus allergy, multiple food allergies
Descrição

Allergy to fish | Allergy to seafood | Allergy to citrus fruit | FOOD ALLERGY TO MULTIPLE FOOD

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0856904
UMLS CUI [2]
C0685900
UMLS CUI [3]
C1690012
UMLS CUI [4]
C0744084
alcohol abuse
Descrição

Alcohol abuse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085762
smokers and tobacco/snuff/nicotine users
Descrição

Tobacco use | Snuff use | Nicotine user

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0543414
UMLS CUI [2]
C0454000
UMLS CUI [3]
C4302494
consumption of food supplements targeted to blood pressure lowering within 30 days before randomization
Descrição

Dietary Supplements Targeted Lowering Blood Pressure

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0242295
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C2003888
UMLS CUI [1,4]
C0005823
pregnant and lactating mothers, women, planning for pregnancy during the study
Descrição

Pregnancy | Breast Feeding | Pregnancy, Planned

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0032992
participation in clinical trials 30 days prior to this study and participation in other clinical intervention
Descrição

Study Subject Participation Status | Clinical Trials | Intervention Clinical

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0205210
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Similar models

Eligibility Hypertension NCT01583582

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Hypertension, mild | Hypertension, moderate | Systolic Pressure | Diastolic blood pressure
Item
mild or moderate hypertension (systolic blood pressure 130 - 160 mmhg and diastolic blood pressure ≤ 100 mmhg)
boolean
C3276943 (UMLS CUI [1])
C1969581 (UMLS CUI [2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Age
Item
age 30 - 75 years
boolean
C0001779 (UMLS CUI [1])
Body Weight
Item
body weight ≥ 60 kg
boolean
C0005910 (UMLS CUI [1])
Stable body weight
Item
stable body weight
boolean
C0517386 (UMLS CUI [1])
Childbearing Potential Contraceptive methods
Item
use of effective contraception in women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Body mass index
Item
body mass index ≥ 35
boolean
C1305855 (UMLS CUI [1])
Antihypertensive therapy | NSAID High dose Regular | Cyclosporine | Tacrolimus
Item
antihypertensive drug treatment, regular high dose nsaid treatment and the use of cyclosporine or tacrolimus
boolean
C0585941 (UMLS CUI [1])
C0003211 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
C0010592 (UMLS CUI [3])
C0085149 (UMLS CUI [4])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
diabetes (type 1 and 2)
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Anemia | Electrolytes abnormal | Proteinuria | Liver Dysfunction | Abnormal renal function | Thyroid function tests abnormal | Biochemical finding Clinical Significance | Hematology Clinical Significance
Item
anemia, abnormal electrolytes, proteinuria, abnormal liver, kidney and thyroid function, clinically significant biochemistry, any other clinically significant hematology and/or biochemistry at the investigator's discretion
boolean
C0002871 (UMLS CUI [1])
C0151613 (UMLS CUI [2])
C0033687 (UMLS CUI [3])
C0086565 (UMLS CUI [4])
C0151746 (UMLS CUI [5])
C0476414 (UMLS CUI [6])
C0428132 (UMLS CUI [7,1])
C2826293 (UMLS CUI [7,2])
C0200627 (UMLS CUI [8,1])
C2826293 (UMLS CUI [8,2])
Cardiovascular Disease | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty | Transient Ischemic Attack | Cerebrovascular accident | Congestive heart failure
Item
cardiovascular disease (myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, temporal ischemic attack within six months prior to screening) including stroke and congestive heart failure
boolean
C0007222 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C2936173 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0038454 (UMLS CUI [7])
C0018802 (UMLS CUI [8])
Secondary hypertension | History of cancer | Malignant disease
Item
secondary hypertension history of cancer or malignant disease within the past five years
boolean
C0155616 (UMLS CUI [1])
C0455471 (UMLS CUI [2])
C0442867 (UMLS CUI [3])
Metabolic Disease | Gastrointestinal Disease | Disease Interferes with Research results | Disease Interferes with Patient safety
Item
any metabolic disease, gastrointestinal disorder or other clinically significant disease/disorder which in the investigator's opinion could interfere with the results of the study or the safety of the subjects
boolean
C0025517 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
Allergy to fish | Allergy to seafood | Allergy to citrus fruit | FOOD ALLERGY TO MULTIPLE FOOD
Item
fish and other seafood allergies, citrus allergy, multiple food allergies
boolean
C0856904 (UMLS CUI [1])
C0685900 (UMLS CUI [2])
C1690012 (UMLS CUI [3])
C0744084 (UMLS CUI [4])
Alcohol abuse
Item
alcohol abuse
boolean
C0085762 (UMLS CUI [1])
Tobacco use | Snuff use | Nicotine user
Item
smokers and tobacco/snuff/nicotine users
boolean
C0543414 (UMLS CUI [1])
C0454000 (UMLS CUI [2])
C4302494 (UMLS CUI [3])
Dietary Supplements Targeted Lowering Blood Pressure
Item
consumption of food supplements targeted to blood pressure lowering within 30 days before randomization
boolean
C0242295 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C2003888 (UMLS CUI [1,3])
C0005823 (UMLS CUI [1,4])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
pregnant and lactating mothers, women, planning for pregnancy during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Study Subject Participation Status | Clinical Trials | Intervention Clinical
Item
participation in clinical trials 30 days prior to this study and participation in other clinical intervention
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0184661 (UMLS CUI [3,1])
C0205210 (UMLS CUI [3,2])
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