ID

15801

Descrição

IVIg for Demyelination in Diabetes Mellitus; ODM derived from: https://clinicaltrials.gov/show/NCT02372149

Link

https://clinicaltrials.gov/show/NCT02372149

Palavras-chave

Versões (1)
  1. 14/06/2016 14/06/2016 -
Transferido a

14 de junho de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Peripheral Neuropathy NCT02372149

Inglês

Eligibility Peripheral Neuropathy NCT02372149

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age ≥18 years.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. diabetes, as per american diabetes association criteria.
Descrição

Diabetes Mellitus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011849
3. clinical evidence of polyneuropathy and ncs shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:
Descrição

Polyneuropathy | Nerve conduction study | Motor nerve Median | Motor nerve Ulnar | Motor nerve tibial | Motor nerve Peroneal | Demyelination

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0152025
UMLS CUI [2]
C0200125
UMLS CUI [3,1]
C0501384
UMLS CUI [3,2]
C2939193
UMLS CUI [4,1]
C0501384
UMLS CUI [4,2]
C0442044
UMLS CUI [5,1]
C0501384
UMLS CUI [5,2]
C0040184
UMLS CUI [6,1]
C0501384
UMLS CUI [6,2]
C0442035
UMLS CUI [7]
C0011304
1. conduction velocity <90% lower limit of normal (lln), distal latency >110% upper limit of normal (uln), or minimal f-wave latency >110% uln
Descrição

Conduction velocity | Latency Motor nerve Distal | Latency F wave

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0234084
UMLS CUI [2,1]
C0242465
UMLS CUI [2,2]
C0501384
UMLS CUI [2,3]
C0205108
UMLS CUI [3,1]
C0242465
UMLS CUI [3,2]
C0429081
2. the changes are not exclusively due to median neuropathy at the wrist, ulnar neuropathy at the elbow, or peroneal neuropathy at the fibular head.
Descrição

Change Due to Median Neuropathy Wrist | Change Due to Ulnar Neuropathy Elbow | Change Due to peroneal neuropathy at the fibular head

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0392747
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0751922
UMLS CUI [1,4]
C0043262
UMLS CUI [2,1]
C0392747
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0154743
UMLS CUI [2,4]
C0013769
UMLS CUI [3,1]
C0392747
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C3662126
4. clinical suspicion of possible demyelinating polyneuropathy (cidp).
Descrição

Peripheral demyelinating neuropathy Suspicion

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0270922
UMLS CUI [1,2]
C0242114
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant patients, or those of childbearing potential not using contraception.
Descrição

Pregnancy | Childbearing Potential | Contraceptive methods Not used

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0445107
2. patients <18 years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
3. presence of an alternative etiology of peripheral neuropathy, such as: hereditary neuropathies (charcot marie-tooth disease); b-vitamin deficiency- or excess-related neuropathy; uremic neuropathy; neuropathy secondary to monoclonal gammopathy; history of cancer- or chemotherapy-related neuropathy; other toxin exposures; and alcoholic neuropathy.
Descrição

Peripheral Neuropathy | Etiology aspects | Inherited neuropathies | Charcot-Marie-Tooth Disease | Neuropathy Due Vitamin B Deficiency | Neuropathy Due to Excess | Uremic neuropathy | Neuropathy Secondary to Monoclonal Gammapathies | Neuropathy Due to Malignant Neoplasms | Neuropathy Due to Chemotherapy | Exposure to toxin | Alcoholic Neuropathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0031117
UMLS CUI [2]
C0015127
UMLS CUI [3]
C0598589
UMLS CUI [4]
C0007959
UMLS CUI [5,1]
C0442874
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0042850
UMLS CUI [6,1]
C0442874
UMLS CUI [6,2]
C0678226
UMLS CUI [6,3]
C1979886
UMLS CUI [7]
C0268708
UMLS CUI [8,1]
C0442874
UMLS CUI [8,2]
C0175668
UMLS CUI [8,3]
C1136085
UMLS CUI [9,1]
C0442874
UMLS CUI [9,2]
C0678226
UMLS CUI [9,3]
C0006826
UMLS CUI [10,1]
C0442874
UMLS CUI [10,2]
C0678226
UMLS CUI [10,3]
C0392920
UMLS CUI [11]
C0040537
UMLS CUI [12]
C0085677
4. contraindication to ivig, including: history of recurrent thrombosis, immunoglobulin a deficiency, or severe hypersensitivity reaction to ivig in past, renal failure, recurrent deep venous thrombosis, pulmonary embolus, stroke, or myocardial infarction.
Descrição

Medical contraindication Immunoglobulins, Intravenous | Recurrent thrombophlebitis | Immunoglobulin A deficiency | Hypersensitivity Immunoglobulins, Intravenous | Kidney Failure | Recurrent deep vein thrombosis | Pulmonary Embolism | Cerebrovascular accident | Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0085297
UMLS CUI [2]
C3550150
UMLS CUI [3]
C0162538
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0085297
UMLS CUI [5]
C0035078
UMLS CUI [6]
C1735901
UMLS CUI [7]
C0034065
UMLS CUI [8]
C0038454
UMLS CUI [9]
C0027051
5. presence of serious or unstable medical condition, which may preclude study completion or lead to inability to tolerate ivig. this may include active heart failure, uncontrolled hypertension, or severe anemia, among other conditions.
Descrição

medical condition Compliance behavior Limited | medical condition Immunoglobulins, Intravenous Unable | Heart failure | Uncontrolled hypertension | Anemia, severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1699700
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
UMLS CUI [2,1]
C1699700
UMLS CUI [2,2]
C0085297
UMLS CUI [2,3]
C1299582
UMLS CUI [3]
C0018801
UMLS CUI [4]
C1868885
UMLS CUI [5]
C0238644
6. presence of concomitant neurological illness, which may confound evaluation.
Descrição

nervous system disorder Interferes with Evaluation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0220825
7. fails or unable to provide informed consent.
Descrição

Informed Consent failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0231175
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Similar models

Eligibility Peripheral Neuropathy NCT02372149

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus
Item
2. diabetes, as per american diabetes association criteria.
boolean
C0011849 (UMLS CUI [1])
Polyneuropathy | Nerve conduction study | Motor nerve Median | Motor nerve Ulnar | Motor nerve tibial | Motor nerve Peroneal | Demyelination
Item
3. clinical evidence of polyneuropathy and ncs shows 2 separate motor nerves (median, ulnar, tibial, or peroneal) which meet criteria for demyelination, defined as follows:
boolean
C0152025 (UMLS CUI [1])
C0200125 (UMLS CUI [2])
C0501384 (UMLS CUI [3,1])
C2939193 (UMLS CUI [3,2])
C0501384 (UMLS CUI [4,1])
C0442044 (UMLS CUI [4,2])
C0501384 (UMLS CUI [5,1])
C0040184 (UMLS CUI [5,2])
C0501384 (UMLS CUI [6,1])
C0442035 (UMLS CUI [6,2])
C0011304 (UMLS CUI [7])
Conduction velocity | Latency Motor nerve Distal | Latency F wave
Item
1. conduction velocity <90% lower limit of normal (lln), distal latency >110% upper limit of normal (uln), or minimal f-wave latency >110% uln
boolean
C0234084 (UMLS CUI [1])
C0242465 (UMLS CUI [2,1])
C0501384 (UMLS CUI [2,2])
C0205108 (UMLS CUI [2,3])
C0242465 (UMLS CUI [3,1])
C0429081 (UMLS CUI [3,2])
Change Due to Median Neuropathy Wrist | Change Due to Ulnar Neuropathy Elbow | Change Due to peroneal neuropathy at the fibular head
Item
2. the changes are not exclusively due to median neuropathy at the wrist, ulnar neuropathy at the elbow, or peroneal neuropathy at the fibular head.
boolean
C0392747 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0751922 (UMLS CUI [1,3])
C0043262 (UMLS CUI [1,4])
C0392747 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0154743 (UMLS CUI [2,3])
C0013769 (UMLS CUI [2,4])
C0392747 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C3662126 (UMLS CUI [3,3])
Peripheral demyelinating neuropathy Suspicion
Item
4. clinical suspicion of possible demyelinating polyneuropathy (cidp).
boolean
C0270922 (UMLS CUI [1,1])
C0242114 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Childbearing Potential | Contraceptive methods Not used
Item
1. pregnant patients, or those of childbearing potential not using contraception.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0445107 (UMLS CUI [3,2])
Age
Item
2. patients <18 years of age.
boolean
C0001779 (UMLS CUI [1])
Peripheral Neuropathy | Etiology aspects | Inherited neuropathies | Charcot-Marie-Tooth Disease | Neuropathy Due Vitamin B Deficiency | Neuropathy Due to Excess | Uremic neuropathy | Neuropathy Secondary to Monoclonal Gammapathies | Neuropathy Due to Malignant Neoplasms | Neuropathy Due to Chemotherapy | Exposure to toxin | Alcoholic Neuropathy
Item
3. presence of an alternative etiology of peripheral neuropathy, such as: hereditary neuropathies (charcot marie-tooth disease); b-vitamin deficiency- or excess-related neuropathy; uremic neuropathy; neuropathy secondary to monoclonal gammopathy; history of cancer- or chemotherapy-related neuropathy; other toxin exposures; and alcoholic neuropathy.
boolean
C0031117 (UMLS CUI [1])
C0015127 (UMLS CUI [2])
C0598589 (UMLS CUI [3])
C0007959 (UMLS CUI [4])
C0442874 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0042850 (UMLS CUI [5,3])
C0442874 (UMLS CUI [6,1])
C0678226 (UMLS CUI [6,2])
C1979886 (UMLS CUI [6,3])
C0268708 (UMLS CUI [7])
C0442874 (UMLS CUI [8,1])
C0175668 (UMLS CUI [8,2])
C1136085 (UMLS CUI [8,3])
C0442874 (UMLS CUI [9,1])
C0678226 (UMLS CUI [9,2])
C0006826 (UMLS CUI [9,3])
C0442874 (UMLS CUI [10,1])
C0678226 (UMLS CUI [10,2])
C0392920 (UMLS CUI [10,3])
C0040537 (UMLS CUI [11])
C0085677 (UMLS CUI [12])
Medical contraindication Immunoglobulins, Intravenous | Recurrent thrombophlebitis | Immunoglobulin A deficiency | Hypersensitivity Immunoglobulins, Intravenous | Kidney Failure | Recurrent deep vein thrombosis | Pulmonary Embolism | Cerebrovascular accident | Myocardial Infarction
Item
4. contraindication to ivig, including: history of recurrent thrombosis, immunoglobulin a deficiency, or severe hypersensitivity reaction to ivig in past, renal failure, recurrent deep venous thrombosis, pulmonary embolus, stroke, or myocardial infarction.
boolean
C1301624 (UMLS CUI [1,1])
C0085297 (UMLS CUI [1,2])
C3550150 (UMLS CUI [2])
C0162538 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0085297 (UMLS CUI [4,2])
C0035078 (UMLS CUI [5])
C1735901 (UMLS CUI [6])
C0034065 (UMLS CUI [7])
C0038454 (UMLS CUI [8])
C0027051 (UMLS CUI [9])
medical condition Compliance behavior Limited | medical condition Immunoglobulins, Intravenous Unable | Heart failure | Uncontrolled hypertension | Anemia, severe
Item
5. presence of serious or unstable medical condition, which may preclude study completion or lead to inability to tolerate ivig. this may include active heart failure, uncontrolled hypertension, or severe anemia, among other conditions.
boolean
C1699700 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C1699700 (UMLS CUI [2,1])
C0085297 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3])
C1868885 (UMLS CUI [4])
C0238644 (UMLS CUI [5])
nervous system disorder Interferes with Evaluation
Item
6. presence of concomitant neurological illness, which may confound evaluation.
boolean
C0027765 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
Informed Consent failed
Item
7. fails or unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
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