ID

39908

Descripción

A Human Trial to Assess the Low Density Lipoprotein Cholesterol (LDL-C) Lowering Effect of Soy; ODM derived from: https://clinicaltrials.gov/show/NCT01547585

Link

https://clinicaltrials.gov/show/NCT01547585

Palabras clave

Versiones (1)
  1. 3/3/20 3/3/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

3 de marzo de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Hypercholesterolemia NCT01547585

Inglés

Eligibility Hypercholesterolemia NCT01547585

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
males and females (not pregnant or lactating) aged 30-70 year
Descripción

Age | Pregnancy Absent | Breast Feeding Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
body mass index (bmi) ≤40kg/m² and ≥18.5kg/m²
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
fasting plasma total cholesterol ≥5.0
Descripción

Plasma total cholesterol level Fasting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1272107
UMLS CUI [1,2]
C0015663
fasting plasma ldl cholesterol ≥3.0 and <5.0 mmol/l.
Descripción

Plasma fasting LDL cholesterol measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583328
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
fasting plasma triglycerides ≥4.0 mmol/l
Descripción

Plasma fasting triglyceride measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583331
abnormal liver and kidney function
Descripción

Liver Dysfunction | Abnormal renal function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0151746
unstable body weight(>3kg change in 3 months) or intention to lose or gain weight;
Descripción

Body Weight Unstable | Wants to lose weight | Intention Weight Gain

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0421273
UMLS CUI [3,1]
C1283828
UMLS CUI [3,2]
C0043094
diabetes mellitus (fasting plasma glucose ≥7.0 mmol/l or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
Descripción

Diabetes Mellitus | Plasma fasting glucose measurement | Insulin use | Hypoglycemic Agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0583513
UMLS CUI [3]
C0240016
UMLS CUI [4]
C0020616
use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
Descripción

Medication use | Drugs, Non-Prescription | Prebiotics | Probiotics | Herbal Supplements Affecting Blood lipids | Dietary Supplements Affecting Blood lipids | Exception Thyroxine Dose Stable | Exception Oral Contraceptives | Exception Hormone replacement therapy | Exception Pharmaceutical Preparations Control of blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0240320
UMLS CUI [2]
C0013231
UMLS CUI [3]
C2717875
UMLS CUI [4]
C0525033
UMLS CUI [5,1]
C1504473
UMLS CUI [5,2]
C0392760
UMLS CUI [5,3]
C0596192
UMLS CUI [6,1]
C0242295
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0596192
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0040165
UMLS CUI [7,3]
C0178602
UMLS CUI [7,4]
C0205360
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C0009905
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0282402
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0013227
UMLS CUI [10,3]
C1753303
major surgical or medical events within the past 3 months;
Descripción

Major surgery Recent | Medical condition Major Recent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0332185
presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
Descripción

Gastrointestinal Disease | Pharmaceutical Preparations Changing Digestion Nutrients | Pharmaceutical Preparations Changing Nutrient absorption | Use of Antibiotics

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0012238
UMLS CUI [2,4]
C0678695
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C1961155
UMLS CUI [4,1]
C1524063
UMLS CUI [4,2]
C0003232
consumption of a diet containing ≥15% of energy from saturated fat;
Descripción

Diet high in saturated fats

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0425441
any food allergy or aversion or unwillingness to eat wheat, soy or milk;
Descripción

Food Allergy | Aversion Wheat | Aversion Soy | Aversion Milk

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0016470
UMLS CUI [2,1]
C0233496
UMLS CUI [2,2]
C0043137
UMLS CUI [3,1]
C0233496
UMLS CUI [3,2]
C0037733
UMLS CUI [4,1]
C0233496
UMLS CUI [4,2]
C2825079
consumption of ≥5 servings per week of soy based food products;
Descripción

Soy bean product Serving U/week

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1532456
UMLS CUI [1,2]
C1519269
UMLS CUI [1,3]
C0560588
consumption of an average of >2 alcoholic beverages per day;
Descripción

Consumption Alcoholic Beverages U/day

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0001967
UMLS CUI [1,3]
C0456683
regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars
Descripción

Tobacco use Regular

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0205272
Volver a la parte superior de la página

Similar models

Eligibility Hypercholesterolemia NCT01547585

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Pregnancy Absent | Breast Feeding Absent
Item
males and females (not pregnant or lactating) aged 30-70 year
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Body mass index
Item
body mass index (bmi) ≤40kg/m² and ≥18.5kg/m²
boolean
C1305855 (UMLS CUI [1])
Plasma total cholesterol level Fasting
Item
fasting plasma total cholesterol ≥5.0
boolean
C1272107 (UMLS CUI [1,1])
C0015663 (UMLS CUI [1,2])
Plasma fasting LDL cholesterol measurement
Item
fasting plasma ldl cholesterol ≥3.0 and <5.0 mmol/l.
boolean
C0583328 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Plasma fasting triglyceride measurement
Item
fasting plasma triglycerides ≥4.0 mmol/l
boolean
C0583331 (UMLS CUI [1])
Liver Dysfunction | Abnormal renal function
Item
abnormal liver and kidney function
boolean
C0086565 (UMLS CUI [1])
C0151746 (UMLS CUI [2])
Body Weight Unstable | Wants to lose weight | Intention Weight Gain
Item
unstable body weight(>3kg change in 3 months) or intention to lose or gain weight;
boolean
C0005910 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0421273 (UMLS CUI [2])
C1283828 (UMLS CUI [3,1])
C0043094 (UMLS CUI [3,2])
Diabetes Mellitus | Plasma fasting glucose measurement | Insulin use | Hypoglycemic Agents
Item
diabetes mellitus (fasting plasma glucose ≥7.0 mmol/l or use of insulin or any hypoglycemic or anti-hyperglycemic medication);
boolean
C0011849 (UMLS CUI [1])
C0583513 (UMLS CUI [2])
C0240016 (UMLS CUI [3])
C0020616 (UMLS CUI [4])
Medication use | Drugs, Non-Prescription | Prebiotics | Probiotics | Herbal Supplements Affecting Blood lipids | Dietary Supplements Affecting Blood lipids | Exception Thyroxine Dose Stable | Exception Oral Contraceptives | Exception Hormone replacement therapy | Exception Pharmaceutical Preparations Control of blood pressure
Item
use of any prescription or non-prescription drug, prebiotics or probiotics, herbal or nutritional supplement known to affect blood lipids, except for stable doses (no change in 3 months) of thyroxine, oral contraceptive agents, hormone replacement therapy, and medications for controlling blood pressure);
boolean
C0240320 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C2717875 (UMLS CUI [3])
C0525033 (UMLS CUI [4])
C1504473 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0596192 (UMLS CUI [5,3])
C0242295 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0596192 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C0040165 (UMLS CUI [7,2])
C0178602 (UMLS CUI [7,3])
C0205360 (UMLS CUI [7,4])
C1705847 (UMLS CUI [8,1])
C0009905 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0282402 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0013227 (UMLS CUI [10,2])
C1753303 (UMLS CUI [10,3])
Major surgery Recent | Medical condition Major Recent
Item
major surgical or medical events within the past 3 months;
boolean
C0679637 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
Gastrointestinal Disease | Pharmaceutical Preparations Changing Digestion Nutrients | Pharmaceutical Preparations Changing Nutrient absorption | Use of Antibiotics
Item
presence of a gastrointestinal disorder or medication that alters the digestion and absorption of nutrients; including antibiotic use within the past 6 weeks.
boolean
C0017178 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0012238 (UMLS CUI [2,3])
C0678695 (UMLS CUI [2,4])
C0013227 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C1961155 (UMLS CUI [3,3])
C1524063 (UMLS CUI [4,1])
C0003232 (UMLS CUI [4,2])
Diet high in saturated fats
Item
consumption of a diet containing ≥15% of energy from saturated fat;
boolean
C0425441 (UMLS CUI [1])
Food Allergy | Aversion Wheat | Aversion Soy | Aversion Milk
Item
any food allergy or aversion or unwillingness to eat wheat, soy or milk;
boolean
C0016470 (UMLS CUI [1])
C0233496 (UMLS CUI [2,1])
C0043137 (UMLS CUI [2,2])
C0233496 (UMLS CUI [3,1])
C0037733 (UMLS CUI [3,2])
C0233496 (UMLS CUI [4,1])
C2825079 (UMLS CUI [4,2])
Soy bean product Serving U/week
Item
consumption of ≥5 servings per week of soy based food products;
boolean
C1532456 (UMLS CUI [1,1])
C1519269 (UMLS CUI [1,2])
C0560588 (UMLS CUI [1,3])
Consumption Alcoholic Beverages U/day
Item
consumption of an average of >2 alcoholic beverages per day;
boolean
C0001948 (UMLS CUI [1,1])
C0001967 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Tobacco use Regular
Item
regular smokers (smoking ≥1 cigarette per day) of cigarettes or cigars
boolean
C0543414 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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