ID

39158

Description

Pharmacokinetics of Immunosuppressants in Renal Transplant Candidates Who Have Undergone Laparoscopic Sleeve Gastrectomy; ODM derived from: https://clinicaltrials.gov/show/NCT02221583

Link

https://clinicaltrials.gov/show/NCT02221583

Keywords

Versions (1)
  1. 12/6/19 12/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT02221583

English

Eligibility End Stage Renal Disease NCT02221583

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female or male patient aged > 18 years old.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. esrd patient (on dialysis or preemptive) who is a potential candidate for kidney transplantation
Description

Kidney Failure, Chronic | Dialysis | Patient Appropriate Kidney Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0022661
UMLS CUI [2]
C0011946
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0022671
3. undergone laparoscopic sleeve gastrectomy procedure > 3 months prior to enrollment.
Description

Laparoscopic sleeve gastrectomy

Data type

boolean

Alias
UMLS CUI [1]
C1960816
4. subjects have signed and dated the informed consent to participate in the study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients taking a drug known to interact with astagraf xl, prograf®, or mmf.
Description

Pharmaceutical Preparations Interaction Astagraf XL | Pharmaceutical Preparations Interaction Prograf | Pharmaceutical Preparations Interaction MMF

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0687133
UMLS CUI [1,3]
C3666776
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0687133
UMLS CUI [2,3]
C0678125
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0687133
UMLS CUI [3,3]
C0209368
2. patients that have an allergy to astagraf xl, prograf®, or mmf.
Description

Hypersensitivity Astagraf XL | Hypersensitivity Prograf | Hypersensitivity MMF

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3666776
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0678125
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0209368
3. patients currently taking astagraf xl, prograf®, or mmf.
Description

Astagraf XL | Prograf | MMF

Data type

boolean

Alias
UMLS CUI [1]
C3666776
UMLS CUI [2]
C0678125
UMLS CUI [3]
C0209368
4. post-surgical leak complication
Description

Leak Complication Postoperative

Data type

boolean

Alias
UMLS CUI [1,1]
C0332234
UMLS CUI [1,2]
C0009566
UMLS CUI [1,3]
C0032790
5. patients failing to adhere to post laparoscopic sleeve gastrectomy follow-up recommendations and clinic visits
Description

Adherence failed Laparoscopic sleeve gastrectomy Follow-up | Adherence failed Clinic Visits

Data type

boolean

Alias
UMLS CUI [1,1]
C1510802
UMLS CUI [1,2]
C0231175
UMLS CUI [1,3]
C1960816
UMLS CUI [1,4]
C3274571
UMLS CUI [2,1]
C1510802
UMLS CUI [2,2]
C0231175
UMLS CUI [2,3]
C0008952
6. patients with any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation.
Description

Medical condition Severe Treatment required for | Medical condition Severe | Requirement Treatment chronic | Medical condition Interferes with Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C1514873
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0205191
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
7. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive laboratory test
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
8. currently taking or planning to initiate of any medications that could interfere with tacrolimus and/or mycophenolate blood levels, including over the counter (otc) medications, herbal supplements, grapefruit or grapefruit juice.
Description

Pharmaceutical Preparations Interfere with Blood tacrolimus level | Pharmaceutical Preparations Interfere with Mycophenolate level | Drugs, Non-Prescription | Herbal Supplements | Grapefruit | GRAPEFRUIT JUICE

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1271702
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C3669267
UMLS CUI [3]
C0013231
UMLS CUI [4]
C1504473
UMLS CUI [5]
C0995150
UMLS CUI [6]
C0452456
9. subjects who have been exposed to an investigational therapy within 30 days prior to enrollment or 5 half-lives of the investigational product, whichever is greater.
Description

Exposure to Investigational Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0949266
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Similar models

Eligibility End Stage Renal Disease NCT02221583

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. female or male patient aged > 18 years old.
boolean
C0001779 (UMLS CUI [1])
Kidney Failure, Chronic | Dialysis | Patient Appropriate Kidney Transplantation
Item
2. esrd patient (on dialysis or preemptive) who is a potential candidate for kidney transplantation
boolean
C0022661 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0022671 (UMLS CUI [3,3])
Laparoscopic sleeve gastrectomy
Item
3. undergone laparoscopic sleeve gastrectomy procedure > 3 months prior to enrollment.
boolean
C1960816 (UMLS CUI [1])
Informed Consent
Item
4. subjects have signed and dated the informed consent to participate in the study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pharmaceutical Preparations Interaction Astagraf XL | Pharmaceutical Preparations Interaction Prograf | Pharmaceutical Preparations Interaction MMF
Item
1. patients taking a drug known to interact with astagraf xl, prograf®, or mmf.
boolean
C0013227 (UMLS CUI [1,1])
C0687133 (UMLS CUI [1,2])
C3666776 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0687133 (UMLS CUI [2,2])
C0678125 (UMLS CUI [2,3])
C0013227 (UMLS CUI [3,1])
C0687133 (UMLS CUI [3,2])
C0209368 (UMLS CUI [3,3])
Hypersensitivity Astagraf XL | Hypersensitivity Prograf | Hypersensitivity MMF
Item
2. patients that have an allergy to astagraf xl, prograf®, or mmf.
boolean
C0020517 (UMLS CUI [1,1])
C3666776 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0678125 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0209368 (UMLS CUI [3,2])
Astagraf XL | Prograf | MMF
Item
3. patients currently taking astagraf xl, prograf®, or mmf.
boolean
C3666776 (UMLS CUI [1])
C0678125 (UMLS CUI [2])
C0209368 (UMLS CUI [3])
Leak Complication Postoperative
Item
4. post-surgical leak complication
boolean
C0332234 (UMLS CUI [1,1])
C0009566 (UMLS CUI [1,2])
C0032790 (UMLS CUI [1,3])
Adherence failed Laparoscopic sleeve gastrectomy Follow-up | Adherence failed Clinic Visits
Item
5. patients failing to adhere to post laparoscopic sleeve gastrectomy follow-up recommendations and clinic visits
boolean
C1510802 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C1960816 (UMLS CUI [1,3])
C3274571 (UMLS CUI [1,4])
C1510802 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0008952 (UMLS CUI [2,3])
Medical condition Severe Treatment required for | Medical condition Severe | Requirement Treatment chronic | Medical condition Interferes with Study Subject Participation Status
Item
6. patients with any severe medical condition requiring acute or chronic treatment that in the investigator's opinion would interfere with study participation.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0205191 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
7. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive laboratory test
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Interfere with Blood tacrolimus level | Pharmaceutical Preparations Interfere with Mycophenolate level | Drugs, Non-Prescription | Herbal Supplements | Grapefruit | GRAPEFRUIT JUICE
Item
8. currently taking or planning to initiate of any medications that could interfere with tacrolimus and/or mycophenolate blood levels, including over the counter (otc) medications, herbal supplements, grapefruit or grapefruit juice.
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1271702 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C3669267 (UMLS CUI [2,3])
C0013231 (UMLS CUI [3])
C1504473 (UMLS CUI [4])
C0995150 (UMLS CUI [5])
C0452456 (UMLS CUI [6])
Exposure to Investigational Therapy
Item
9. subjects who have been exposed to an investigational therapy within 30 days prior to enrollment or 5 half-lives of the investigational product, whichever is greater.
boolean
C0332157 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
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