ID

39158

Beschreibung

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

Stichworte

Versionen (1)
  1. 06.12.19 06.12.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. Dezember 2019

DOI

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Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT02221583

Englisch

Eligibility End Stage Renal Disease NCT02221583

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Age

Datentyp

boolean

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

Kidney Failure, Chronic | Dialysis | Patient Appropriate Kidney Transplantation

Datentyp

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.
Beschreibung

Laparoscopic sleeve gastrectomy

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

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.
Beschreibung

Hypersensitivity Astagraf XL | Hypersensitivity Prograf | Hypersensitivity MMF

Datentyp

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.
Beschreibung

Astagraf XL | Prograf | MMF

Datentyp

boolean

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

Leak Complication Postoperative

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Pregnancy | Breast Feeding

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Exposure to Investigational Therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0949266
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Ähnliche Modelle

Eligibility End Stage Renal Disease NCT02221583

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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