ID

30057

Beschrijving

Electrodiagnostic Parameters in Patients With Impaired Glucose Tolerance and Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT01094418

Link

https://clinicaltrials.gov/show/NCT01094418

Trefwoorden

Versies (1)
  1. 07-05-18 07-05-18 -
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See clinicaltrials.gov

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7 mei 2018

DOI

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Creative Commons BY 4.0
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Eligibility Impaired Glucose Tolerance NCT01094418

Engels

Eligibility Impaired Glucose Tolerance NCT01094418

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
for the normal healthy control group
Beschrijving

Healthy Control Group

Datatype

boolean

Alias
UMLS CUI [1,1]
C3898900
UMLS CUI [1,2]
C0009932
healthy participants with normal ncs parameters
Beschrijving

Healthy Volunteers | Nerve conduction study Parameter Normal

Datatype

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0200125
UMLS CUI [2,2]
C0549193
UMLS CUI [2,3]
C0205307
for the igt group
Beschrijving

Impaired glucose tolerance Group

Datatype

boolean

Alias
UMLS CUI [1,1]
C0271650
UMLS CUI [1,2]
C0441833
men or women aged 20-70 with igt referred by the department of endocrinology, with fbs 100-126 mg/dl, post 2 hour ott - 140-200mg/dl,lasting more than one year.
Beschrijving

Age | Impaired glucose tolerance | Fasting Blood Sugar Measurement | Oral Glucose Tolerance Test

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0271650
UMLS CUI [3]
C2825162
UMLS CUI [4]
C0029161
patients willing to undergo ncs.
Beschrijving

Nerve conduction study Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200125
UMLS CUI [1,2]
C0600109
for the dm group
Beschrijving

Diabetes Mellitus Group

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441833
men or women aged 20-70 with dm type ii patients referred by the department of endocrinology, with no previous diagnosis of peripheral polyneuropathy and who showed snap amplitudes of the sural and superficial peroneal nerves above 10ma.
Beschrijving

Age | Diabetes Mellitus, Non-Insulin-Dependent | Peripheral polyneuropathy Absent | SNAP amplitude Sural nerve | SNAP amplitude Superficial peroneal nerve

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0011860
UMLS CUI [3,1]
C2673754
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0457380
UMLS CUI [4,2]
C1278864
UMLS CUI [5,1]
C0457380
UMLS CUI [5,2]
C1278868
patients willing to undergo ncs.
Beschrijving

Nerve conduction study Willing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0200125
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no previous diagnosis of any systemic condition related to peripheral polyneuropathy (malnutrition, alcoholic hepatitis, diabetes mellitus( normal group)), no previous medication history, such as chemotherapeutics
Beschrijving

Systemic disease Relationship Peripheral polyneuropathy | Malnutrition | Hepatitis, Alcoholic | Diabetes Mellitus | Pharmacotherapy | Chemotherapeutic agent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0439849
UMLS CUI [1,3]
C2673754
UMLS CUI [2]
C0162429
UMLS CUI [3]
C0019187
UMLS CUI [4]
C0011849
UMLS CUI [5]
C0013216
UMLS CUI [6]
C0729502
no symptom or sign of peripheral polyneuropathy, no history of tingling sensation, muscle weakness, or gait disturbance
Beschrijving

Sign or Symptom Peripheral polyneuropathy | Tingling sensation | Muscle Weakness | Gait abnormality

Datatype

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C2673754
UMLS CUI [2]
C2242996
UMLS CUI [3]
C0151786
UMLS CUI [4]
C0575081
skin lesion or swelling that would interfere with ncs conduction
Beschrijving

Skin lesion Interferes with Nerve conduction study | Swelling Interferes with Nerve conduction study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037284
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0200125
UMLS CUI [2,1]
C0038999
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0200125
previous diagnosis or clinical symptoms that would indicate the presence of mononeuropathy or entrapment neuropathy of the lower extremity.
Beschrijving

Prior diagnosis Mononeuropathy Lower Extremity | Prior diagnosis Entrapment Neuropathy Lower Extremity | Symptoms Mononeuropathy Lower Extremity | Symptoms Entrapment Neuropathy Lower Extremity

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332132
UMLS CUI [1,2]
C0494491
UMLS CUI [1,3]
C0023216
UMLS CUI [2,1]
C0332132
UMLS CUI [2,2]
C1510429
UMLS CUI [2,3]
C0023216
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0494491
UMLS CUI [3,3]
C0023216
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C1510429
UMLS CUI [4,3]
C0023216
previous trauma episode of the lower extremity
Beschrijving

Trauma Episode Lower Extremity

Datatype

boolean

Alias
UMLS CUI [1,1]
C3714660
UMLS CUI [1,2]
C0332189
UMLS CUI [1,3]
C0023216
history of alcohol ( exceeding alcohol consumption of 170g per week ) or substance abuse,
Beschrijving

Substance Use Disorders | Alcohol consumption Gram per week

Datatype

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C0556978
pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
dm group
Beschrijving

Diabetes Mellitus Group

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0441833
presence of undiagnosed peripheral polyneuropathy determined by screening of the sural and superficial peroneal nerves.
Beschrijving

Peripheral polyneuropathy Undiagnosed | Screening Sural nerve | Screening Superficial peroneal nerve

Datatype

boolean

Alias
UMLS CUI [1,1]
C2673754
UMLS CUI [1,2]
C1408353
UMLS CUI [2,1]
C0220908
UMLS CUI [2,2]
C1278864
UMLS CUI [3,1]
C0220908
UMLS CUI [3,2]
C1278868
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Similar models

Eligibility Impaired Glucose Tolerance NCT01094418

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Control Group
Item
for the normal healthy control group
boolean
C3898900 (UMLS CUI [1,1])
C0009932 (UMLS CUI [1,2])
Healthy Volunteers | Nerve conduction study Parameter Normal
Item
healthy participants with normal ncs parameters
boolean
C1708335 (UMLS CUI [1])
C0200125 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
Impaired glucose tolerance Group
Item
for the igt group
boolean
C0271650 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Age | Impaired glucose tolerance | Fasting Blood Sugar Measurement | Oral Glucose Tolerance Test
Item
men or women aged 20-70 with igt referred by the department of endocrinology, with fbs 100-126 mg/dl, post 2 hour ott - 140-200mg/dl,lasting more than one year.
boolean
C0001779 (UMLS CUI [1])
C0271650 (UMLS CUI [2])
C2825162 (UMLS CUI [3])
C0029161 (UMLS CUI [4])
Nerve conduction study Willing
Item
patients willing to undergo ncs.
boolean
C0200125 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Diabetes Mellitus Group
Item
for the dm group
boolean
C0011849 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Age | Diabetes Mellitus, Non-Insulin-Dependent | Peripheral polyneuropathy Absent | SNAP amplitude Sural nerve | SNAP amplitude Superficial peroneal nerve
Item
men or women aged 20-70 with dm type ii patients referred by the department of endocrinology, with no previous diagnosis of peripheral polyneuropathy and who showed snap amplitudes of the sural and superficial peroneal nerves above 10ma.
boolean
C0001779 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C2673754 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0457380 (UMLS CUI [4,1])
C1278864 (UMLS CUI [4,2])
C0457380 (UMLS CUI [5,1])
C1278868 (UMLS CUI [5,2])
Nerve conduction study Willing
Item
patients willing to undergo ncs.
boolean
C0200125 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Systemic disease Relationship Peripheral polyneuropathy | Malnutrition | Hepatitis, Alcoholic | Diabetes Mellitus | Pharmacotherapy | Chemotherapeutic agent
Item
no previous diagnosis of any systemic condition related to peripheral polyneuropathy (malnutrition, alcoholic hepatitis, diabetes mellitus( normal group)), no previous medication history, such as chemotherapeutics
boolean
C0442893 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C2673754 (UMLS CUI [1,3])
C0162429 (UMLS CUI [2])
C0019187 (UMLS CUI [3])
C0011849 (UMLS CUI [4])
C0013216 (UMLS CUI [5])
C0729502 (UMLS CUI [6])
Sign or Symptom Peripheral polyneuropathy | Tingling sensation | Muscle Weakness | Gait abnormality
Item
no symptom or sign of peripheral polyneuropathy, no history of tingling sensation, muscle weakness, or gait disturbance
boolean
C3540840 (UMLS CUI [1,1])
C2673754 (UMLS CUI [1,2])
C2242996 (UMLS CUI [2])
C0151786 (UMLS CUI [3])
C0575081 (UMLS CUI [4])
Skin lesion Interferes with Nerve conduction study | Swelling Interferes with Nerve conduction study
Item
skin lesion or swelling that would interfere with ncs conduction
boolean
C0037284 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0200125 (UMLS CUI [1,3])
C0038999 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0200125 (UMLS CUI [2,3])
Prior diagnosis Mononeuropathy Lower Extremity | Prior diagnosis Entrapment Neuropathy Lower Extremity | Symptoms Mononeuropathy Lower Extremity | Symptoms Entrapment Neuropathy Lower Extremity
Item
previous diagnosis or clinical symptoms that would indicate the presence of mononeuropathy or entrapment neuropathy of the lower extremity.
boolean
C0332132 (UMLS CUI [1,1])
C0494491 (UMLS CUI [1,2])
C0023216 (UMLS CUI [1,3])
C0332132 (UMLS CUI [2,1])
C1510429 (UMLS CUI [2,2])
C0023216 (UMLS CUI [2,3])
C1457887 (UMLS CUI [3,1])
C0494491 (UMLS CUI [3,2])
C0023216 (UMLS CUI [3,3])
C1457887 (UMLS CUI [4,1])
C1510429 (UMLS CUI [4,2])
C0023216 (UMLS CUI [4,3])
Trauma Episode Lower Extremity
Item
previous trauma episode of the lower extremity
boolean
C3714660 (UMLS CUI [1,1])
C0332189 (UMLS CUI [1,2])
C0023216 (UMLS CUI [1,3])
Substance Use Disorders | Alcohol consumption Gram per week
Item
history of alcohol ( exceeding alcohol consumption of 170g per week ) or substance abuse,
boolean
C0038586 (UMLS CUI [1])
C0001948 (UMLS CUI [2,1])
C0556978 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Diabetes Mellitus Group
Item
dm group
boolean
C0011849 (UMLS CUI [1,1])
C0441833 (UMLS CUI [1,2])
Peripheral polyneuropathy Undiagnosed | Screening Sural nerve | Screening Superficial peroneal nerve
Item
presence of undiagnosed peripheral polyneuropathy determined by screening of the sural and superficial peroneal nerves.
boolean
C2673754 (UMLS CUI [1,1])
C1408353 (UMLS CUI [1,2])
C0220908 (UMLS CUI [2,1])
C1278864 (UMLS CUI [2,2])
C0220908 (UMLS CUI [3,1])
C1278868 (UMLS CUI [3,2])
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