ID

29291

Beschreibung

Omega-3 Fatty Acid Administration in Dialysis Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00655525

Link

https://clinicaltrials.gov/show/NCT00655525

Stichworte

Versionen (1)
  1. 16.03.18 16.03.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. März 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility End Stage Renal Disease NCT00655525

Englisch

Eligibility End Stage Renal Disease NCT00655525

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients on chd for more than 6 months;
Beschreibung

Coronary heart disease Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0010068
UMLS CUI [1,2]
C0872146
ability to read and sign the consent form;
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
have acceptable dialysis adequacy (kt/v > 1.2);
Beschreibung

Kt/V (peritoneal dialysis adequacy index)

Datentyp

boolean

Alias
UMLS CUI [1]
C3841650
use biocompatible hemodialysis membrane;
Beschreibung

Hemodialysis membrane Biocompatible materials

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4047366
UMLS CUI [1,2]
C0005479
have a patent, well functioning, arteriovenous dialysis access or permanent dialysis catheter (no other option for arteriovenous access);
Beschreibung

Dialysis access Arteriovenous Patent | Dialysis catheter Permanent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3483464
UMLS CUI [1,2]
C0450109
UMLS CUI [1,3]
C0175566
UMLS CUI [2,1]
C0179747
UMLS CUI [2,2]
C0205355
signs of chronic inflammation (average crp of ≥ 5 mg/l for 3 consecutive measurements)
Beschreibung

Signs Chronic inflammation | C-reactive protein measurement Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0311392
UMLS CUI [1,2]
C0021376
UMLS CUI [2,1]
C0201657
UMLS CUI [2,2]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnancy;
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
intolerance to the study medication;
Beschreibung

Intolerance to Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0013230
severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, hiv, liver disease);
Beschreibung

Inflammatory disorder Severe | Inflammatory disorder Unstable | Inflammatory disorder | Chronic inflammatory disorder | Communicable Disease | Connective Tissue Diseases | Malignant Neoplasms | HIV Infection | Liver disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1290884
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1290884
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C1290884
UMLS CUI [4]
C1290886
UMLS CUI [5]
C0009450
UMLS CUI [6]
C0009782
UMLS CUI [7]
C0006826
UMLS CUI [8]
C0019693
UMLS CUI [9]
C0023895
diabetes mellitus on insulin therapy;
Beschreibung

Insulin regime Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0011849
hospitalization within 1 month prior to the study;
Beschreibung

Hospitalization

Datentyp

boolean

Alias
UMLS CUI [1]
C0019993
malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 500 ml/min);
Beschreibung

Malfunction Vascular access Arteriovenous | Blood flow measurement

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0231174
UMLS CUI [1,2]
C0750138
UMLS CUI [1,3]
C0450109
UMLS CUI [2]
C0005776
patients receiving steroids (> 5 mg/day) and/or other immunosuppressive agents;
Beschreibung

Steroids U/day | Immunosuppressive Agents

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0456683
UMLS CUI [2]
C0021081
life-expectancy less than 6 months;
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
age less than 18 years old;
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
atrial fibrillation (only for those undergoing the optional pulse wave velocity);
Beschreibung

Atrial Fibrillation | Relationship Pulse Wave Velocity

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C0439849
UMLS CUI [2,2]
C3494431
hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery doppler).
Beschreibung

Hypersensitivity Nitrates organic | Hypersensitivity Isosorbide | Hypersensitivity Nitroglycerin | Relationship Doppler blood flow measurement Brachial artery

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0028125
UMLS CUI [1,3]
C0747055
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0022251
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0017887
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0599582
UMLS CUI [4,3]
C0006087
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Ähnliche Modelle

Eligibility End Stage Renal Disease NCT00655525

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Coronary heart disease Disease length
Item
patients on chd for more than 6 months;
boolean
C0010068 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Informed Consent
Item
ability to read and sign the consent form;
boolean
C0021430 (UMLS CUI [1])
Kt/V (peritoneal dialysis adequacy index)
Item
have acceptable dialysis adequacy (kt/v > 1.2);
boolean
C3841650 (UMLS CUI [1])
Hemodialysis membrane Biocompatible materials
Item
use biocompatible hemodialysis membrane;
boolean
C4047366 (UMLS CUI [1,1])
C0005479 (UMLS CUI [1,2])
Dialysis access Arteriovenous Patent | Dialysis catheter Permanent
Item
have a patent, well functioning, arteriovenous dialysis access or permanent dialysis catheter (no other option for arteriovenous access);
boolean
C3483464 (UMLS CUI [1,1])
C0450109 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C0179747 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
Signs Chronic inflammation | C-reactive protein measurement Quantity
Item
signs of chronic inflammation (average crp of ≥ 5 mg/l for 3 consecutive measurements)
boolean
C0311392 (UMLS CUI [1,1])
C0021376 (UMLS CUI [1,2])
C0201657 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
pregnancy;
boolean
C0032961 (UMLS CUI [1])
Intolerance to Investigational New Drugs
Item
intolerance to the study medication;
boolean
C1744706 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Inflammatory disorder Severe | Inflammatory disorder Unstable | Inflammatory disorder | Chronic inflammatory disorder | Communicable Disease | Connective Tissue Diseases | Malignant Neoplasms | HIV Infection | Liver disease
Item
severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, hiv, liver disease);
boolean
C1290884 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1290884 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1290884 (UMLS CUI [3])
C1290886 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C0009782 (UMLS CUI [6])
C0006826 (UMLS CUI [7])
C0019693 (UMLS CUI [8])
C0023895 (UMLS CUI [9])
Insulin regime Diabetes Mellitus
Item
diabetes mellitus on insulin therapy;
boolean
C0557978 (UMLS CUI [1,1])
C0011849 (UMLS CUI [1,2])
Hospitalization
Item
hospitalization within 1 month prior to the study;
boolean
C0019993 (UMLS CUI [1])
Malfunction Vascular access Arteriovenous | Blood flow measurement
Item
malfunctioning arterial-venous vascular access (recirculation and/or blood flow < 500 ml/min);
boolean
C0231174 (UMLS CUI [1,1])
C0750138 (UMLS CUI [1,2])
C0450109 (UMLS CUI [1,3])
C0005776 (UMLS CUI [2])
Steroids U/day | Immunosuppressive Agents
Item
patients receiving steroids (> 5 mg/day) and/or other immunosuppressive agents;
boolean
C0038317 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0021081 (UMLS CUI [2])
Life Expectancy
Item
life-expectancy less than 6 months;
boolean
C0023671 (UMLS CUI [1])
Age
Item
age less than 18 years old;
boolean
C0001779 (UMLS CUI [1])
Atrial Fibrillation | Relationship Pulse Wave Velocity
Item
atrial fibrillation (only for those undergoing the optional pulse wave velocity);
boolean
C0004238 (UMLS CUI [1])
C0439849 (UMLS CUI [2,1])
C3494431 (UMLS CUI [2,2])
Hypersensitivity Nitrates organic | Hypersensitivity Isosorbide | Hypersensitivity Nitroglycerin | Relationship Doppler blood flow measurement Brachial artery
Item
hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery doppler).
boolean
C0020517 (UMLS CUI [1,1])
C0028125 (UMLS CUI [1,2])
C0747055 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0022251 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0017887 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C0599582 (UMLS CUI [4,2])
C0006087 (UMLS CUI [4,3])
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