ID

22868

Descripción

Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00672204

Link

https://clinicaltrials.gov/show/NCT00672204

Palabras clave

Versiones (1)
  1. 13/6/17 13/6/17 -
Subido en

13 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 1 Diabetes Mellitus NCT00672204

Inglés

Eligibility Type 1 Diabetes Mellitus NCT00672204

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. primary islet allotransplant
Descripción

primary islet allotransplant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205225
UMLS CUI [1,2]
C1515895
UMLS CUI [1,3]
C0079646
2. type i diabetes mellitus for a minimum of 5 years
Descripción

type i diabetes mellitus, duration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0449238
3. one of the following signs or symptoms despite intensive efforts made in close cooperation with their diabetic care team:
Descripción

signs or symptoms, diabetic care

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C1272423
metabolic lability/instability characterized by hypoglycemia or ketoacidosis (>2 hospital admissions in the previous year), erratic glucose profiles (mage>120 mg/dl), or disruption in lifestyle of danger to life, self or others
Descripción

hypoglycemia, ketoacidosis, hospital admissions, erratic glucose profiles, disruption in lifestyle of danger to life, self or others

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0220982
UMLS CUI [1,3]
C0184666
UMLS CUI [2]
C0428548
UMLS CUI [3,1]
C0023676
UMLS CUI [3,2]
C2826244
reduced awareness of hypoglycemia or >1 episode in the last 1.5 years of severe hypoglycemia
Descripción

reduced awareness of hypoglycemia, episode of severe hypoglycemia

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392756
UMLS CUI [1,2]
C1389777
UMLS CUI [1,3]
C0020615
UMLS CUI [2]
C4013228
persistently poor glucose control (as defined by hgba1c>10% at the end of six months of intensive management efforts with the diabetes care team)
Descripción

poor glucose control, hba1c

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0421258
UMLS CUI [1,2]
C0202054
progressive secondary complications as defined by (i) a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or (ii) urinary albumin excretion rate >300 mg/day but proteinuria <3g/day; or (iii) symptomatic autonomic neuropathy (as defined by postural hypotension in the setting of euvolemia, gastroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder as diagnosed by an urologist)
Descripción

secondary complications, proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation, urinary albumin excretion rate, proteinuria, symptomatic autonomic neuropathy, postural hypotension, astroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0342257
UMLS CUI [2,1]
C0339467
UMLS CUI [2,2]
C0730284
UMLS CUI [2,3]
C0395565
UMLS CUI [3,1]
C1318429
UMLS CUI [3,2]
C0033687
UMLS CUI [4,1]
C0271686
UMLS CUI [4,2]
C2676407
UMLS CUI [4,3]
C0267176
UMLS CUI [4,4]
C0342288
UMLS CUI [4,5]
C0005697
4. age 18 to 65 years of age.
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. current use of immunosuppressive agents
Descripción

immunosuppressive agents

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021081
2. lymphopenia (<1000/µl) or leukopenia (<3000 total leukocytes/µl)
Descripción

lymphopenia or leukopenia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0024312
UMLS CUI [2]
C0023530
3. presence of panel-reactive anti-hla antibody >20%
Descripción

panel-reactive anti-hla antibody

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3508207
4. positive lymphocytotoxic cross-match using donor lymphocytes and serum
Descripción

lymphocytotoxic cross-match

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0549171
5. evidence of acute ebv infection (igm>igg) or negative screen for ebv by igg determination
Descripción

ebv infection, ebv serology

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0149678
UMLS CUI [1,2]
C0201373
6. calculated or measured gfr < 60 ml/min/m2
Descripción

gfr

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017654
7. portal hypertension or history of significant liver disease
Descripción

portal hypertension, liver disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0020541
UMLS CUI [2]
C0023895
8. history of malignancy within 10 years (except for adequately treated basal or squamous cell ca of the skin)
Descripción

history of malignancy except for adequately treated basal or squamous cell ca of the skin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2735088
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0553723
9. active peptic ulcer disease
Descripción

active peptic ulcer disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030920
UMLS CUI [1,2]
C2707252
10. severe unremitting diarrhea or other gi disorders potentially interfering with the ability to absorb oral medications
Descripción

severe diarrhea, gi disorders potentially interfering with the ability to absorb oral medications

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1443924
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392687
11. untreated proliferative retinopathy
Descripción

untreated proliferative retinopathy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0339467
UMLS CUI [1,2]
C0332155
12. pregnancy or breastfeeding
Descripción

pregnancy or breastfeeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
13. female subjects not post-menopausal or surgically sterile, or not using an acceptable method of contraception
Descripción

female subjects not post-menopausal or surgically sterile, or not using an acceptable method of contraception

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1960468
UMLS CUI [1,2]
C0015787
UMLS CUI [1,3]
C0232970
UMLS CUI [1,4]
C0700589
14. active infections
Descripción

active infections

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C3714514
15. serologic evidence of infection with hiv, or hbsag or hcv ab positive
Descripción

hiv, hep b, hep c

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019682
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
16. major ongoing psychiatric illness
Descripción

psychiatric illness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0004936
17. ongoing substance abuse, drug or alcohol; or recent history of noncompliance
Descripción

substance use disorder, compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C1321605
18. any condition that in the opinion of the principle investigator would not allow for safe participation in the study
Descripción

comorbidity, exclusion

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2828389
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Similar models

Eligibility Type 1 Diabetes Mellitus NCT00672204

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
primary islet allotransplant
Item
1. primary islet allotransplant
boolean
C0205225 (UMLS CUI [1,1])
C1515895 (UMLS CUI [1,2])
C0079646 (UMLS CUI [1,3])
type i diabetes mellitus, duration
Item
2. type i diabetes mellitus for a minimum of 5 years
boolean
C0011854 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
signs or symptoms, diabetic care
Item
3. one of the following signs or symptoms despite intensive efforts made in close cooperation with their diabetic care team:
boolean
C3540840 (UMLS CUI [1,1])
C1272423 (UMLS CUI [1,2])
hypoglycemia, ketoacidosis, hospital admissions, erratic glucose profiles, disruption in lifestyle of danger to life, self or others
Item
metabolic lability/instability characterized by hypoglycemia or ketoacidosis (>2 hospital admissions in the previous year), erratic glucose profiles (mage>120 mg/dl), or disruption in lifestyle of danger to life, self or others
boolean
C0020615 (UMLS CUI [1,1])
C0220982 (UMLS CUI [1,2])
C0184666 (UMLS CUI [1,3])
C0428548 (UMLS CUI [2])
C0023676 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
reduced awareness of hypoglycemia, episode of severe hypoglycemia
Item
reduced awareness of hypoglycemia or >1 episode in the last 1.5 years of severe hypoglycemia
boolean
C0392756 (UMLS CUI [1,1])
C1389777 (UMLS CUI [1,2])
C0020615 (UMLS CUI [1,3])
C4013228 (UMLS CUI [2])
poor glucose control, hba1c
Item
persistently poor glucose control (as defined by hgba1c>10% at the end of six months of intensive management efforts with the diabetes care team)
boolean
C0421258 (UMLS CUI [1,1])
C0202054 (UMLS CUI [1,2])
secondary complications, proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation, urinary albumin excretion rate, proteinuria, symptomatic autonomic neuropathy, postural hypotension, astroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder
Item
progressive secondary complications as defined by (i) a new diagnosis by an ophthalmologist of proliferative retinopathy or clinically significant macular edema or therapy with photocoagulation during the last year; or (ii) urinary albumin excretion rate >300 mg/day but proteinuria <3g/day; or (iii) symptomatic autonomic neuropathy (as defined by postural hypotension in the setting of euvolemia, gastroparesis or diarrhea attributed to diabetic neuropathy, or neuropathic bladder as diagnosed by an urologist)
boolean
C0342257 (UMLS CUI [1])
C0339467 (UMLS CUI [2,1])
C0730284 (UMLS CUI [2,2])
C0395565 (UMLS CUI [2,3])
C1318429 (UMLS CUI [3,1])
C0033687 (UMLS CUI [3,2])
C0271686 (UMLS CUI [4,1])
C2676407 (UMLS CUI [4,2])
C0267176 (UMLS CUI [4,3])
C0342288 (UMLS CUI [4,4])
C0005697 (UMLS CUI [4,5])
age
Item
4. age 18 to 65 years of age.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
immunosuppressive agents
Item
1. current use of immunosuppressive agents
boolean
C0021081 (UMLS CUI [1])
lymphopenia or leukopenia
Item
2. lymphopenia (<1000/µl) or leukopenia (<3000 total leukocytes/µl)
boolean
C0024312 (UMLS CUI [1])
C0023530 (UMLS CUI [2])
panel-reactive anti-hla antibody
Item
3. presence of panel-reactive anti-hla antibody >20%
boolean
C3508207 (UMLS CUI [1])
lymphocytotoxic cross-match
Item
4. positive lymphocytotoxic cross-match using donor lymphocytes and serum
boolean
C0549171 (UMLS CUI [1])
ebv infection, ebv serology
Item
5. evidence of acute ebv infection (igm>igg) or negative screen for ebv by igg determination
boolean
C0149678 (UMLS CUI [1,1])
C0201373 (UMLS CUI [1,2])
gfr
Item
6. calculated or measured gfr < 60 ml/min/m2
boolean
C0017654 (UMLS CUI [1])
portal hypertension, liver disease
Item
7. portal hypertension or history of significant liver disease
boolean
C0020541 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
history of malignancy except for adequately treated basal or squamous cell ca of the skin
Item
8. history of malignancy within 10 years (except for adequately treated basal or squamous cell ca of the skin)
boolean
C2735088 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0553723 (UMLS CUI [3])
active peptic ulcer disease
Item
9. active peptic ulcer disease
boolean
C0030920 (UMLS CUI [1,1])
C2707252 (UMLS CUI [1,2])
severe diarrhea, gi disorders potentially interfering with the ability to absorb oral medications
Item
10. severe unremitting diarrhea or other gi disorders potentially interfering with the ability to absorb oral medications
boolean
C1443924 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392687 (UMLS CUI [2,2])
untreated proliferative retinopathy
Item
11. untreated proliferative retinopathy
boolean
C0339467 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
pregnancy or breastfeeding
Item
12. pregnancy or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
female subjects not post-menopausal or surgically sterile, or not using an acceptable method of contraception
Item
13. female subjects not post-menopausal or surgically sterile, or not using an acceptable method of contraception
boolean
C1960468 (UMLS CUI [1,1])
C0015787 (UMLS CUI [1,2])
C0232970 (UMLS CUI [1,3])
C0700589 (UMLS CUI [1,4])
active infections
Item
14. active infections
boolean
C0205177 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
hiv, hep b, hep c
Item
15. serologic evidence of infection with hiv, or hbsag or hcv ab positive
boolean
C0019682 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
psychiatric illness
Item
16. major ongoing psychiatric illness
boolean
C0004936 (UMLS CUI [1])
substance use disorder, compliance
Item
17. ongoing substance abuse, drug or alcohol; or recent history of noncompliance
boolean
C0038586 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
comorbidity, exclusion
Item
18. any condition that in the opinion of the principle investigator would not allow for safe participation in the study
boolean
C0009488 (UMLS CUI [1,1])
C2828389 (UMLS CUI [1,2])
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