ID

28326

Descripción

Ginger for Colorectal Cancer Prevention; ODM derived from: https://clinicaltrials.gov/show/NCT01344538

Link

https://clinicaltrials.gov/show/NCT01344538

Palabras clave

Versiones (1)
  1. 4/1/18 4/1/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

4 de enero de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Colorectal Cancer NCT01344538

Inglés

Eligibility Colorectal Cancer NCT01344538

1 formularios  
Criteria
Descripción

Criteria

18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry.
Descripción

Age | Good health | Medical History | Hematologic Tests | Chemistry | Complete Blood Count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3813622
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0018941
UMLS CUI [5]
C0151339
UMLS CUI [6]
C0009555
no chronic medication use was allowed and participants could not have taken aspirin or related nsaids during the study or 14 days before the first dose of the study medication.
Descripción

Pharmaceutical Preparations chronic Absent | Aspirin Absent | NSAIDs Related Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0332197
participants also had to be classified as being at normal-risk for developing colorectal cancer. normal-risk was defined as having: no first-degree relatives with colon cancer diagnosed before the age of 60; no personal history of colorectal cancer and no adenomas >1 cm in size or containing carcinoma in situ
Descripción

Risk Normal Colorectal Carcinoma | Absence First Degree Relative Colon Carcinoma | Age | Colorectal Carcinoma Absent | Absence Adenoma Size | Absence Adenoma Containing Carcinoma in Situ

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0009402
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1517194
UMLS CUI [2,3]
C0699790
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0009402
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0001430
UMLS CUI [5,3]
C0456389
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0001430
UMLS CUI [6,3]
C0332256
UMLS CUI [6,4]
C0007099
exclusion criteria for both normal and increased risk for colorectal cancer:
Descripción

Exclusion Criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
1. a history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors;
Descripción

Peptic Ulcer | Gastrointestinal Hemorrhage Due to Gastric ulcer | Gastrointestinal Hemorrhage Due to Duodenal Ulcer | Gastrin secreting tumor

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0030920
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0038358
UMLS CUI [3,1]
C0017181
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0013295
UMLS CUI [4]
C0017150
2. pregnant or lactating women;
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
3. history of cardiovascular disease;
Descripción

Cardiovascular Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
4. lactose intolerance;
Descripción

Lactose Intolerance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0022951
5. or an allergy to ginger
Descripción

Hypersensitivity Ginger

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0162751
6. a history of familial colorectal cancer syndromes;.
Descripción

Colorectal Carcinoma Familial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0241888
inclusion criteria increased risk:
Descripción

Inclusion criteria Risk Increased

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0035647
UMLS CUI [1,3]
C0205217
18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry.
Descripción

Age | Good health | Medical History | Hematologic Tests | Chemistry | Complete Blood Count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3813622
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0018941
UMLS CUI [5]
C0151339
UMLS CUI [6]
C0009555
no chronic medication use was allowed and participants could not have taken aspirin or related nsaids during the study or 14 days before the first dose of the study medication.
Descripción

Pharmaceutical Preparations chronic Absent | Aspirin Absent | NSAIDs Related Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0004057
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0003211
UMLS CUI [3,2]
C0439849
UMLS CUI [3,3]
C0332197
participants also had to be classified as being at increased-risk for developing colorectal cancer. increased-risk is defined as having at least one of the following: a first-degree relatives with colon cancer diagnosed before the age of 60; a personal history of early stage colorectal cancer and/or no adenomas >1 cm in size or containing carcinoma in situ
Descripción

Risk Increased Colorectal Carcinoma | First Degree Relative Colon Carcinoma | Age | Colorectal Carcinoma Early stage | Absence Adenoma Size | Absence Adenoma Containing Carcinoma in Situ

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C0205217
UMLS CUI [1,3]
C0009402
UMLS CUI [2,1]
C1517194
UMLS CUI [2,2]
C0699790
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0009402
UMLS CUI [4,2]
C2363430
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C0001430
UMLS CUI [5,3]
C0456389
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C0001430
UMLS CUI [6,3]
C0332256
UMLS CUI [6,4]
C0007099
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Similar models

Eligibility Colorectal Cancer NCT01344538

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Age | Good health | Medical History | Hematologic Tests | Chemistry | Complete Blood Count
Item
18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry.
boolean
C0001779 (UMLS CUI [1])
C3813622 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0018941 (UMLS CUI [4])
C0151339 (UMLS CUI [5])
C0009555 (UMLS CUI [6])
Pharmaceutical Preparations chronic Absent | Aspirin Absent | NSAIDs Related Absent
Item
no chronic medication use was allowed and participants could not have taken aspirin or related nsaids during the study or 14 days before the first dose of the study medication.
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0004057 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Risk Normal Colorectal Carcinoma | Absence First Degree Relative Colon Carcinoma | Age | Colorectal Carcinoma Absent | Absence Adenoma Size | Absence Adenoma Containing Carcinoma in Situ
Item
participants also had to be classified as being at normal-risk for developing colorectal cancer. normal-risk was defined as having: no first-degree relatives with colon cancer diagnosed before the age of 60; no personal history of colorectal cancer and no adenomas >1 cm in size or containing carcinoma in situ
boolean
C0035647 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C1517194 (UMLS CUI [2,2])
C0699790 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
C0009402 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0332197 (UMLS CUI [5,1])
C0001430 (UMLS CUI [5,2])
C0456389 (UMLS CUI [5,3])
C0332197 (UMLS CUI [6,1])
C0001430 (UMLS CUI [6,2])
C0332256 (UMLS CUI [6,3])
C0007099 (UMLS CUI [6,4])
Exclusion Criteria
Item
exclusion criteria for both normal and increased risk for colorectal cancer:
boolean
C0680251 (UMLS CUI [1])
Peptic Ulcer | Gastrointestinal Hemorrhage Due to Gastric ulcer | Gastrointestinal Hemorrhage Due to Duodenal Ulcer | Gastrin secreting tumor
Item
1. a history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors;
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0038358 (UMLS CUI [2,3])
C0017181 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0013295 (UMLS CUI [3,3])
C0017150 (UMLS CUI [4])
Pregnancy | Breast Feeding
Item
2. pregnant or lactating women;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Cardiovascular Disease
Item
3. history of cardiovascular disease;
boolean
C0007222 (UMLS CUI [1])
Lactose Intolerance
Item
4. lactose intolerance;
boolean
C0022951 (UMLS CUI [1])
Hypersensitivity Ginger
Item
5. or an allergy to ginger
boolean
C0020517 (UMLS CUI [1,1])
C0162751 (UMLS CUI [1,2])
Colorectal Carcinoma Familial
Item
6. a history of familial colorectal cancer syndromes;.
boolean
C0009402 (UMLS CUI [1,1])
C0241888 (UMLS CUI [1,2])
Inclusion criteria Risk Increased
Item
inclusion criteria increased risk:
boolean
C1512693 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0205217 (UMLS CUI [1,3])
Age | Good health | Medical History | Hematologic Tests | Chemistry | Complete Blood Count
Item
18 years or older and in good health as defined by an unremarkable medical history, physical and screening blood work (chemistry screen, complete blood count) within 60 days of study entry.
boolean
C0001779 (UMLS CUI [1])
C3813622 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0018941 (UMLS CUI [4])
C0151339 (UMLS CUI [5])
C0009555 (UMLS CUI [6])
Pharmaceutical Preparations chronic Absent | Aspirin Absent | NSAIDs Related Absent
Item
no chronic medication use was allowed and participants could not have taken aspirin or related nsaids during the study or 14 days before the first dose of the study medication.
boolean
C0013227 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0004057 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0439849 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Risk Increased Colorectal Carcinoma | First Degree Relative Colon Carcinoma | Age | Colorectal Carcinoma Early stage | Absence Adenoma Size | Absence Adenoma Containing Carcinoma in Situ
Item
participants also had to be classified as being at increased-risk for developing colorectal cancer. increased-risk is defined as having at least one of the following: a first-degree relatives with colon cancer diagnosed before the age of 60; a personal history of early stage colorectal cancer and/or no adenomas >1 cm in size or containing carcinoma in situ
boolean
C0035647 (UMLS CUI [1,1])
C0205217 (UMLS CUI [1,2])
C0009402 (UMLS CUI [1,3])
C1517194 (UMLS CUI [2,1])
C0699790 (UMLS CUI [2,2])
C0001779 (UMLS CUI [3])
C0009402 (UMLS CUI [4,1])
C2363430 (UMLS CUI [4,2])
C0332197 (UMLS CUI [5,1])
C0001430 (UMLS CUI [5,2])
C0456389 (UMLS CUI [5,3])
C0332197 (UMLS CUI [6,1])
C0001430 (UMLS CUI [6,2])
C0332256 (UMLS CUI [6,3])
C0007099 (UMLS CUI [6,4])
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