ID

42526

Descripción

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

Palabras clave

Versiones (1)
  1. 18/8/21 18/8/21 -
Titular de derechos de autor

Alan Yu, MB, BChir

Subido en

18 de agosto de 2021

DOI

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Licencia

Creative Commons BY-NC 4.0
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Eligibility Polycystic Kidney Disease NCT02140814

Inglés

Eligibility Polycystic Kidney Disease NCT02140814

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Autosomal dominant polycystic kidney disease

Tipo de datos

boolean

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

EGFR | CKD-EPI equation

Tipo de datos

boolean

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

Ability to give an informed consent in english

Tipo de datos

boolean

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

Exclusion Criteria

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

History of liver disease | History of abnormal liver function test

Tipo de datos

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
Descripción

Alcohol abuse severe

Tipo de datos

boolean

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

Chronic diarrhea | Malabsorption syndrome

Tipo de datos

boolean

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

Thrombocytopenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0040034
hypophosphatemia
Descripción

Hypophosphatemia

Tipo de datos

boolean

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

Pregnancy | Breast Feeding | Pregnancy planned during the study

Tipo de datos

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
Descripción

Anti-epileptic agents

Tipo de datos

boolean

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

Treatment with tolvaptan recent

Tipo de datos

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
Descripción

Participation in another interventional trial currently or recently

Tipo de datos

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
Descripción

Nephrectomy recent | Partial nephrectomy recent | Renal cyst reduction recent

Tipo de datos

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
Descripción

Cardiac pacemaker

Tipo de datos

boolean

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

Magnetic resonance-incompatible metallic implants

Tipo de datos

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
Descripción

Body weight | Untreatable claustrophobia

Tipo de datos

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 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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