ID

39024

Descrição

Neuroprotection by Tocotrienols in Type 1 and Type 2 Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01973400

Link

https://clinicaltrials.gov/show/NCT01973400

Palavras-chave

Versões (1)
  1. 21/11/2019 21/11/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

21 de novembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diabetic Neuropathy NCT01973400

Inglês

Eligibility Diabetic Neuropathy NCT01973400

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diabetic adults ( both type 1 or 2) ≥20 years old with diabetic peripheral neuropathy with total symptom score(tss) ≥ 3 points.
Descrição

Diabetic | Adult | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Age | Diabetic peripheral neuropathy Total symptom score

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0241863
UMLS CUI [2]
C0001675
UMLS CUI [3]
C0011854
UMLS CUI [4]
C0011860
UMLS CUI [5]
C0001779
UMLS CUI [6,1]
C0740447
UMLS CUI [6,2]
C3533163
patients with type 1 diabetes (duration of ≥5 years).
Descrição

Insulin-Dependent Diabetes Mellitus Disease length

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
patients with type 2 diabetes (at diagnosis).
Descrição

Diabetes Mellitus, Non-Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
patients with neuropathy impairment score(nis) > 2
Descrição

Neuropathy Impairment Score

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0449820
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients hba1c >12%.
Descrição

Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0474680
patients with hypoglycemia or conscious impairment at the time of test conduction.
Descrição

Hypoglycemia | Conscious Impairment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0020615
UMLS CUI [2,1]
C0234421
UMLS CUI [2,2]
C0221099
patients exhibiting symptoms of peripheral vascular disease with absence of 2 foot pulses on the same foot (posterior tibialis, dorsalis pedis)
Descrição

Symptoms Peripheral Vascular Disease | Absence Foot pulse Quantity Foot | Tibialis posterior in foot | Dorsalis pedis artery

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0085096
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0232157
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0016504
UMLS CUI [3]
C1305633
UMLS CUI [4]
C0226492
immuno-compromised patients.
Descrição

Immunocompromised patient

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085393
patients with severe visual impairment, history of psychosis; schizophrenia; bipolar disorder; current depression or brain trauma and patients with alcohol dependence or drug abuse such as cocaine, heroin, etc.
Descrição

Visual Impairment Severe | Psychotic Disorders | Schizophrenia | Bipolar Disorder | Depressive disorder | Traumatic Brain Injury | Alcoholic Intoxication, Chronic | Drug abuse | Cocaine Abuse | Heroin abuse

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3665347
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0036341
UMLS CUI [4]
C0005586
UMLS CUI [5]
C0011581
UMLS CUI [6]
C0876926
UMLS CUI [7]
C0001973
UMLS CUI [8]
C0013146
UMLS CUI [9]
C0009171
UMLS CUI [10]
C0600241
those having lesions with a propensity to bleed (e.g., bleeding peptic ulcers), those having a history of hemorrhagic stroke and those with inherited bleeding disorders (e.g., hemophilia) or patients on warfarin.
Descrição

Lesion with Bleeding tendency | Peptic Ulcer Hemorrhage | Brain hemorrhage | Blood Coagulation Disorders Hereditary | Hemophilia | Warfarin therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C1458140
UMLS CUI [2]
C0030922
UMLS CUI [3]
C0553692
UMLS CUI [4,1]
C0005779
UMLS CUI [4,2]
C0439660
UMLS CUI [5]
C0684275
UMLS CUI [6]
C4303340
pregnancy and lactation.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients with renal function test of more than 150 umol/l (serum creatinine).
Descrição

Kidney Function Test | Serum creatinine measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0022662
UMLS CUI [2]
C0201976
patients with liver function test of more than 5 times of the upper normal range
Descrição

Increased liver function test

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0877359
active infection or infectious diseases.
Descrição

Communicable Diseases

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
other significant uncontrolled medical illnesses that may interfere with drug administration or interpretation of results.
Descrição

Illness Uncontrolled | Interference Administration of medication | Interference Interpretation Research results

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C3469597
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C0459471
UMLS CUI [3,3]
C0683954
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Similar models

Eligibility Diabetic Neuropathy NCT01973400

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diabetic | Adult | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Age | Diabetic peripheral neuropathy Total symptom score
Item
diabetic adults ( both type 1 or 2) ≥20 years old with diabetic peripheral neuropathy with total symptom score(tss) ≥ 3 points.
boolean
C0241863 (UMLS CUI [1])
C0001675 (UMLS CUI [2])
C0011854 (UMLS CUI [3])
C0011860 (UMLS CUI [4])
C0001779 (UMLS CUI [5])
C0740447 (UMLS CUI [6,1])
C3533163 (UMLS CUI [6,2])
Insulin-Dependent Diabetes Mellitus Disease length
Item
patients with type 1 diabetes (duration of ≥5 years).
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
patients with type 2 diabetes (at diagnosis).
boolean
C0011860 (UMLS CUI [1])
Neuropathy Impairment Score
Item
patients with neuropathy impairment score(nis) > 2
boolean
C0442874 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hemoglobin A1c measurement
Item
patients hba1c >12%.
boolean
C0474680 (UMLS CUI [1])
Hypoglycemia | Conscious Impairment
Item
patients with hypoglycemia or conscious impairment at the time of test conduction.
boolean
C0020615 (UMLS CUI [1])
C0234421 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Symptoms Peripheral Vascular Disease | Absence Foot pulse Quantity Foot | Tibialis posterior in foot | Dorsalis pedis artery
Item
patients exhibiting symptoms of peripheral vascular disease with absence of 2 foot pulses on the same foot (posterior tibialis, dorsalis pedis)
boolean
C1457887 (UMLS CUI [1,1])
C0085096 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0232157 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0016504 (UMLS CUI [2,4])
C1305633 (UMLS CUI [3])
C0226492 (UMLS CUI [4])
Immunocompromised patient
Item
immuno-compromised patients.
boolean
C0085393 (UMLS CUI [1])
Visual Impairment Severe | Psychotic Disorders | Schizophrenia | Bipolar Disorder | Depressive disorder | Traumatic Brain Injury | Alcoholic Intoxication, Chronic | Drug abuse | Cocaine Abuse | Heroin abuse
Item
patients with severe visual impairment, history of psychosis; schizophrenia; bipolar disorder; current depression or brain trauma and patients with alcohol dependence or drug abuse such as cocaine, heroin, etc.
boolean
C3665347 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0033975 (UMLS CUI [2])
C0036341 (UMLS CUI [3])
C0005586 (UMLS CUI [4])
C0011581 (UMLS CUI [5])
C0876926 (UMLS CUI [6])
C0001973 (UMLS CUI [7])
C0013146 (UMLS CUI [8])
C0009171 (UMLS CUI [9])
C0600241 (UMLS CUI [10])
Lesion with Bleeding tendency | Peptic Ulcer Hemorrhage | Brain hemorrhage | Blood Coagulation Disorders Hereditary | Hemophilia | Warfarin therapy
Item
those having lesions with a propensity to bleed (e.g., bleeding peptic ulcers), those having a history of hemorrhagic stroke and those with inherited bleeding disorders (e.g., hemophilia) or patients on warfarin.
boolean
C0221198 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C1458140 (UMLS CUI [1,3])
C0030922 (UMLS CUI [2])
C0553692 (UMLS CUI [3])
C0005779 (UMLS CUI [4,1])
C0439660 (UMLS CUI [4,2])
C0684275 (UMLS CUI [5])
C4303340 (UMLS CUI [6])
Pregnancy | Breast Feeding
Item
pregnancy and lactation.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Kidney Function Test | Serum creatinine measurement
Item
patients with renal function test of more than 150 umol/l (serum creatinine).
boolean
C0022662 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Increased liver function test
Item
patients with liver function test of more than 5 times of the upper normal range
boolean
C0877359 (UMLS CUI [1])
Communicable Diseases
Item
active infection or infectious diseases.
boolean
C0009450 (UMLS CUI [1])
Illness Uncontrolled | Interference Administration of medication | Interference Interpretation Research results
Item
other significant uncontrolled medical illnesses that may interfere with drug administration or interpretation of results.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C3469597 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C0459471 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
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