ID

42526

Beschrijving

Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease; ODM derived from: https://clinicaltrials.gov/show/NCT02140814

Link

https://clinicaltrials.gov/show/NCT02140814

Trefwoorden

Versies (1)
  1. 18-08-21 18-08-21 -
Houder van rechten

Alan Yu, MB, BChir

Geüploaded op

18 augustus 2021

DOI

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Licentie

Creative Commons BY-NC 4.0
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Eligibility Polycystic Kidney Disease NCT02140814

Engels

Eligibility Polycystic Kidney Disease NCT02140814

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of autosomal dominant polycystic kidney disease
Beschrijving

Autosomal dominant polycystic kidney disease

Datatype

boolean

Alias
UMLS CUI [1]
C0085413
egfr > 90ml/min/1.73m2 as determined from the serum creatinine by the ckd-epi equation
Beschrijving

EGFR | CKD-EPI equation

Datatype

boolean

Alias
UMLS CUI [1,1]
C3811844
UMLS CUI [1,2]
C2964649
ability to give informed consent in english
Beschrijving

Ability to give an informed consent in english

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C0085732
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of liver disease or abnormal liver function test
Beschrijving

History of liver disease | History of abnormal liver function test

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0587081
UMLS CUI [2,3]
C0205161
UMLS CUI [2,4]
C0262926
heavy alcohol intake
Beschrijving

Alcohol abuse severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0205082
chronic diarrhea or malabsorption syndrome
Beschrijving

Chronic diarrhea | Malabsorption syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0401151
UMLS CUI [2]
C0024523
thrombocytopenia
Beschrijving

Thrombocytopenia

Datatype

boolean

Alias
UMLS CUI [1]
C0040034
hypophosphatemia
Beschrijving

Hypophosphatemia

Datatype

boolean

Alias
UMLS CUI [1]
C0085682
pregnancy or lactation or plan to become pregnant during the study
Beschrijving

Pregnancy | Breast Feeding | Pregnancy planned during the study

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032992
UMLS CUI [3,2]
C0347984
UMLS CUI [3,3]
C0008976
treatment with anti-epileptic drugs
Beschrijving

Anti-epileptic agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003299
treatment with tolvaptan, current or within 2 months prior to screening
Beschrijving

Treatment with tolvaptan recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1176308
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0332185
participation in another interventional trial currently or within 30 days prior to screening
Beschrijving

Participation in another interventional trial currently or recently

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521116
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0332185
partial or total nephrectomy or renal cyst reduction (including aspiration) done <1 year ago
Beschrijving

Nephrectomy recent | Partial nephrectomy recent | Renal cyst reduction recent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027695
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0194086
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C3887499
UMLS CUI [3,2]
C0441610
UMLS CUI [3,3]
C0332185
cardiac pacemaker
Beschrijving

Cardiac pacemaker

Datatype

boolean

Alias
UMLS CUI [1]
C0030163
presence of magnetic resonance-incompatible metallic clips (e.g. clipped cerebral aneurysm)
Beschrijving

Magnetic resonance-incompatible metallic implants

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C2986473
UMLS CUI [1,3]
C0024485
UMLS CUI [1,4]
C0442809
body weight >159 kg (350 lbs) or untreatable claustrophobia
Beschrijving

Body weight | Untreatable claustrophobia

Datatype

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2,1]
C0008909
UMLS CUI [2,2]
C0205269
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Similar models

Eligibility Polycystic Kidney Disease NCT02140814

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Autosomal dominant polycystic kidney disease
Item
confirmed diagnosis of autosomal dominant polycystic kidney disease
boolean
C0085413 (UMLS CUI [1])
EGFR | CKD-EPI equation
Item
egfr > 90ml/min/1.73m2 as determined from the serum creatinine by the ckd-epi equation
boolean
C3811844 (UMLS CUI [1,1])
C2964649 (UMLS CUI [1,2])
Ability to give an informed consent in english
Item
ability to give informed consent in english
boolean
C0021430 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
History of liver disease | History of abnormal liver function test
Item
history of liver disease or abnormal liver function test
boolean
C0023895 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2,1])
C0587081 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
C0262926 (UMLS CUI [2,4])
Alcohol abuse severe
Item
heavy alcohol intake
boolean
C0085762 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Chronic diarrhea | Malabsorption syndrome
Item
chronic diarrhea or malabsorption syndrome
boolean
C0401151 (UMLS CUI [1])
C0024523 (UMLS CUI [2])
Thrombocytopenia
Item
thrombocytopenia
boolean
C0040034 (UMLS CUI [1])
Hypophosphatemia
Item
hypophosphatemia
boolean
C0085682 (UMLS CUI [1])
Pregnancy | Breast Feeding | Pregnancy planned during the study
Item
pregnancy or lactation or plan to become pregnant during the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3,1])
C0347984 (UMLS CUI [3,2])
C0008976 (UMLS CUI [3,3])
Anti-epileptic agents
Item
treatment with anti-epileptic drugs
boolean
C0003299 (UMLS CUI [1])
Treatment with tolvaptan recent
Item
treatment with tolvaptan, current or within 2 months prior to screening
boolean
C1176308 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Participation in another interventional trial currently or recently
Item
participation in another interventional trial currently or within 30 days prior to screening
boolean
C2348568 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Nephrectomy recent | Partial nephrectomy recent | Renal cyst reduction recent
Item
partial or total nephrectomy or renal cyst reduction (including aspiration) done <1 year ago
boolean
C0027695 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0194086 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C3887499 (UMLS CUI [3,1])
C0441610 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
Cardiac pacemaker
Item
cardiac pacemaker
boolean
C0030163 (UMLS CUI [1])
Magnetic resonance-incompatible metallic implants
Item
presence of magnetic resonance-incompatible metallic clips (e.g. clipped cerebral aneurysm)
boolean
C0021102 (UMLS CUI [1,1])
C2986473 (UMLS CUI [1,2])
C0024485 (UMLS CUI [1,3])
C0442809 (UMLS CUI [1,4])
Body weight | Untreatable claustrophobia
Item
body weight >159 kg (350 lbs) or untreatable claustrophobia
boolean
C0005910 (UMLS CUI [1])
C0008909 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
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