ID

38460

Descrição

Evaluation of Oral Alpha-Cyclodextrin for Decreasing Serum Cholesterol; ODM derived from: https://clinicaltrials.gov/show/NCT01131299

Link

https://clinicaltrials.gov/show/NCT01131299

Palavras-chave

Versões (1)
  1. 19/10/2019 19/10/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

19 de outubro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT01131299

Inglês

Eligibility Cardiovascular Disease NCT01131299

1 Formulários  
Criteria
Descrição

Criteria

males and females between the ages of 18-75.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
subject understands protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
Descrição

Comprehension Study Protocol | Informed Consent | Compliance behavior Follow-up

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
UMLS CUI [3,1]
C1321605
UMLS CUI [3,2]
C3274571
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy or women currently breastfeeding.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
bmi less than 18.5
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
subjects with unstable weight that varies greater than 10% over the past 3 months.
Descrição

Body Weight Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0443343
subjects currently following any low-fat (< 20%) diet.
Descrição

Fat-Restricted Diet

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0242970
subjects that routinely consume less than 3 meals/snacks per day
Descrição

Consumption Routine Number of meals per day | Consumption Routine Number of snacks per day

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009830
UMLS CUI [1,2]
C0205547
UMLS CUI [1,3]
C2008797
UMLS CUI [2,1]
C0009830
UMLS CUI [2,2]
C0205547
UMLS CUI [2,3]
C2008798
subjects taking the following medications, which may show reduced absorption with alpha-cd or may otherwise interfere with the study will be excluded: soluble fiber supplements, bas, plant sterol supplements, antibiotics, anticoagulants, anticonvulsants, antiarrhytmics , cyclosporine, mycophenolate, synthroid, vitamin a, e and k and or any drug that is necessary to take with a meal. if any of these medications are initiated during the study, the subjects will be instructed to discontinue the use of the alpha-cd or placebo pills and to withdraw from the study. short-term and prophylactic antibiotics may be taken during study participation for up to 14 days, at least 2 hours apart from the study drug.
Descrição

Soluble fiber supplementation | Bile acid sequestrants | Phytosterol Supplements | Antibiotics | Anticoagulants | Anticonvulsants | Anti-Arrhythmia Agents | Cyclosporine | Mycophenolate | Synthroid | Vitamin A | Vitamin E | Vitamin K

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0556108
UMLS CUI [2]
C2917337
UMLS CUI [3,1]
C0031866
UMLS CUI [3,2]
C0242295
UMLS CUI [4]
C0003232
UMLS CUI [5]
C0003280
UMLS CUI [6]
C0003286
UMLS CUI [7]
C0003195
UMLS CUI [8]
C0010592
UMLS CUI [9]
C0883242
UMLS CUI [10]
C0728762
UMLS CUI [11]
C0042839
UMLS CUI [12]
C0042874
UMLS CUI [13]
C0042878
subjects with chronic diarrhea, gastric bypass or lapband procedures, ostomies, bowel motility problems, or other conditions that could affect intestinal fat absorption.
Descrição

Chronic diarrhea | Gastric Bypass | Gastric band Procedure | Ostomy | Motility disorder of intestine | Condition Affecting Intestinal fat absorption

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0401151
UMLS CUI [2]
C0017125
UMLS CUI [3,1]
C3854330
UMLS CUI [3,2]
C0184661
UMLS CUI [4]
C0029473
UMLS CUI [5]
C0400865
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C0392760
UMLS CUI [6,3]
C0232653
subjects initiating new medications or patients on multiple medications may also be excluded.
Descrição

New medications | Pharmaceutical Preparations multiple

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1718097
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0439064
patients with type i or type ii diabetes.
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
subjects currently taking alpha-cd in its commercial form.
Descrição

alpha-cyclodextrin

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0051348
volunteers may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the volunteer.
Descrição

Condition Interferes with Research results | Disease Interferes with Research results | Condition At risk Patient safety | Disease At risk Patient safety

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C1113679
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C1113679
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Similar models

Eligibility Cardiovascular Disease NCT01131299

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Age
Item
males and females between the ages of 18-75.
boolean
C0001779 (UMLS CUI [1])
Comprehension Study Protocol | Informed Consent | Compliance behavior Follow-up
Item
subject understands protocol and provides written, informed consent in addition to a willingness to comply with specified follow-up evaluations.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
C1321605 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnancy or women currently breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Body mass index
Item
bmi less than 18.5
boolean
C1305855 (UMLS CUI [1])
Body Weight Unstable
Item
subjects with unstable weight that varies greater than 10% over the past 3 months.
boolean
C0005910 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Fat-Restricted Diet
Item
subjects currently following any low-fat (< 20%) diet.
boolean
C0242970 (UMLS CUI [1])
Consumption Routine Number of meals per day | Consumption Routine Number of snacks per day
Item
subjects that routinely consume less than 3 meals/snacks per day
boolean
C0009830 (UMLS CUI [1,1])
C0205547 (UMLS CUI [1,2])
C2008797 (UMLS CUI [1,3])
C0009830 (UMLS CUI [2,1])
C0205547 (UMLS CUI [2,2])
C2008798 (UMLS CUI [2,3])
Soluble fiber supplementation | Bile acid sequestrants | Phytosterol Supplements | Antibiotics | Anticoagulants | Anticonvulsants | Anti-Arrhythmia Agents | Cyclosporine | Mycophenolate | Synthroid | Vitamin A | Vitamin E | Vitamin K
Item
subjects taking the following medications, which may show reduced absorption with alpha-cd or may otherwise interfere with the study will be excluded: soluble fiber supplements, bas, plant sterol supplements, antibiotics, anticoagulants, anticonvulsants, antiarrhytmics , cyclosporine, mycophenolate, synthroid, vitamin a, e and k and or any drug that is necessary to take with a meal. if any of these medications are initiated during the study, the subjects will be instructed to discontinue the use of the alpha-cd or placebo pills and to withdraw from the study. short-term and prophylactic antibiotics may be taken during study participation for up to 14 days, at least 2 hours apart from the study drug.
boolean
C0556108 (UMLS CUI [1])
C2917337 (UMLS CUI [2])
C0031866 (UMLS CUI [3,1])
C0242295 (UMLS CUI [3,2])
C0003232 (UMLS CUI [4])
C0003280 (UMLS CUI [5])
C0003286 (UMLS CUI [6])
C0003195 (UMLS CUI [7])
C0010592 (UMLS CUI [8])
C0883242 (UMLS CUI [9])
C0728762 (UMLS CUI [10])
C0042839 (UMLS CUI [11])
C0042874 (UMLS CUI [12])
C0042878 (UMLS CUI [13])
Chronic diarrhea | Gastric Bypass | Gastric band Procedure | Ostomy | Motility disorder of intestine | Condition Affecting Intestinal fat absorption
Item
subjects with chronic diarrhea, gastric bypass or lapband procedures, ostomies, bowel motility problems, or other conditions that could affect intestinal fat absorption.
boolean
C0401151 (UMLS CUI [1])
C0017125 (UMLS CUI [2])
C3854330 (UMLS CUI [3,1])
C0184661 (UMLS CUI [3,2])
C0029473 (UMLS CUI [4])
C0400865 (UMLS CUI [5])
C0348080 (UMLS CUI [6,1])
C0392760 (UMLS CUI [6,2])
C0232653 (UMLS CUI [6,3])
New medications | Pharmaceutical Preparations multiple
Item
subjects initiating new medications or patients on multiple medications may also be excluded.
boolean
C1718097 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with type i or type ii diabetes.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
alpha-cyclodextrin
Item
subjects currently taking alpha-cd in its commercial form.
boolean
C0051348 (UMLS CUI [1])
Condition Interferes with Research results | Disease Interferes with Research results | Condition At risk Patient safety | Disease At risk Patient safety
Item
volunteers may also be excluded, if in the opinion of the study investigators, they have some other condition or disorder that may adversely affect the outcome of the study or the safety of the volunteer.
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C1113679 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C1113679 (UMLS CUI [4,3])
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