ID

36841

Description

MT-R Followed by Autologous Stem Cells Transplantation in Newly-diagnosed Primary Central Nervous System Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT02399189

Link

https://clinicaltrials.gov/show/NCT02399189

Keywords

Versions (1)
  1. 6/14/19 6/14/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 14, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Primary Central Nervous System Lymphoma NCT02399189

English

Eligibility Primary Central Nervous System Lymphoma NCT02399189

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
fasting c-peptide value of < 0.7 ng/ml (0.23 nmol/l) at visit 2 measured by the central laboratory
Description

Fasting C-peptide level

Data type

boolean

Alias
UMLS CUI [1]
C2208720
use of, and be willing, based on the investigator's judgement, to continue throughout the duration of the trial, either:
Description

Use of

Data type

boolean

Alias
UMLS CUI [1]
C1524063
mdi of insulin consisting of at least one basal insulin injection and at least three daily bolus injections or
Description

Daily Dose Multiple Injection of insulin | Basal insulin Injection Quantity | Bolus infusion Quantity Daily

Data type

boolean

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0439064
UMLS CUI [1,3]
C0199782
UMLS CUI [2,1]
C0650607
UMLS CUI [2,2]
C1828121
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C1511237
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0332173
csii of any insulin type, with at least 5 months experience of using csii prior to visit 1
Description

Continuous subcutaneous infusion of insulin Type Any

Data type

boolean

Alias
UMLS CUI [1,1]
C0393124
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1552551
hba1c >/= 7.5% and </= 10.0% at visit 5 measured by the central laboratory
Description

Hemoglobin A1c measurement

Data type

boolean

Alias
UMLS CUI [1]
C0474680
age >/= 18 years at visit 1
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of t2dm, maturity onset diabetes of the young (mody), pancreatic surgery or chronic pancreatitis
Description

Diabetes Mellitus, Non-Insulin-Dependent | Maturity onset diabetes mellitus in young | Pancreatic surgery | Pancreatitis, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0342276
UMLS CUI [3]
C2033062
UMLS CUI [4]
C0149521
pancreas, pancreatic islet cells or renal transplant recipient
Description

Pancreas transplant recipient | Islets of Langerhans Transplant Recipients | Renal transplant recipient

Data type

boolean

Alias
UMLS CUI [1]
C2033004
UMLS CUI [2,1]
C0022131
UMLS CUI [2,2]
C0376387
UMLS CUI [3]
C2063399
t1dm treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, glp-1 analogues, sglt-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to visit 1
Description

Diabetes Mellitus, Insulin-Dependent | Hypoglycemic Agents | Metformin | alpha-Glucosidase Inhibitors | GLP-1 Analogue | SGLT2 Inhibitor | Pramlintide | Insulin By inhalation | Premixed insulin | Exception Basal insulin Subcutaneous | Exception Insulin Bolus

Data type

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0020616
UMLS CUI [3]
C0025598
UMLS CUI [4]
C1299007
UMLS CUI [5]
C3273809
UMLS CUI [6]
C3273807
UMLS CUI [7]
C0537551
UMLS CUI [8,1]
C0021641
UMLS CUI [8,2]
C0001559
UMLS CUI [9]
C2069057
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0650607
UMLS CUI [10,3]
C1522438
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0021641
UMLS CUI [11,3]
C1705509
occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to visit 1
Description

Hypoglycemia Severe Involving Coma | Hypoglycemia Severe Involving Seizure | Hospitalization Required | Patient need for Emergency treatment Hypoglycemia

Data type

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C1314939
UMLS CUI [1,4]
C0009421
UMLS CUI [2,1]
C0020615
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C1314939
UMLS CUI [2,4]
C0036572
UMLS CUI [3]
C1708385
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0013969
UMLS CUI [4,3]
C0020615
occurence of severe dka (i.e a ph of <7.0 or prolonged intensive care unit admission exceeding two days) requiring hospitalisation within 3 months prior to visit 1
Description

Diabetic Ketoacidosis Severe | Finding of pH | Admission to intensive care unit Prolonged | Hospitalization Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0011880
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C1304686
UMLS CUI [3,1]
C0583239
UMLS CUI [3,2]
C0439590
UMLS CUI [4]
C1708385
additional exclusion criteria may apply
Description

Exclusion Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1524062
Back to the top of the page

Similar models

Eligibility Primary Central Nervous System Lymphoma NCT02399189

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Fasting C-peptide level
Item
fasting c-peptide value of < 0.7 ng/ml (0.23 nmol/l) at visit 2 measured by the central laboratory
boolean
C2208720 (UMLS CUI [1])
Use of
Item
use of, and be willing, based on the investigator's judgement, to continue throughout the duration of the trial, either:
boolean
C1524063 (UMLS CUI [1])
Daily Dose Multiple Injection of insulin | Basal insulin Injection Quantity | Bolus infusion Quantity Daily
Item
mdi of insulin consisting of at least one basal insulin injection and at least three daily bolus injections or
boolean
C2348070 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0199782 (UMLS CUI [1,3])
C0650607 (UMLS CUI [2,1])
C1828121 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C1511237 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0332173 (UMLS CUI [3,3])
Continuous subcutaneous infusion of insulin Type Any
Item
csii of any insulin type, with at least 5 months experience of using csii prior to visit 1
boolean
C0393124 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Hemoglobin A1c measurement
Item
hba1c >/= 7.5% and </= 10.0% at visit 5 measured by the central laboratory
boolean
C0474680 (UMLS CUI [1])
Age
Item
age >/= 18 years at visit 1
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Maturity onset diabetes mellitus in young | Pancreatic surgery | Pancreatitis, Chronic
Item
history of t2dm, maturity onset diabetes of the young (mody), pancreatic surgery or chronic pancreatitis
boolean
C0011860 (UMLS CUI [1])
C0342276 (UMLS CUI [2])
C2033062 (UMLS CUI [3])
C0149521 (UMLS CUI [4])
Pancreas transplant recipient | Islets of Langerhans Transplant Recipients | Renal transplant recipient
Item
pancreas, pancreatic islet cells or renal transplant recipient
boolean
C2033004 (UMLS CUI [1])
C0022131 (UMLS CUI [2,1])
C0376387 (UMLS CUI [2,2])
C2063399 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Hypoglycemic Agents | Metformin | alpha-Glucosidase Inhibitors | GLP-1 Analogue | SGLT2 Inhibitor | Pramlintide | Insulin By inhalation | Premixed insulin | Exception Basal insulin Subcutaneous | Exception Insulin Bolus
Item
t1dm treatment with any other antihyperglycaemic drug (e.g. metformin, alpha-glucosidase inhibitors, glp-1 analogues, sglt-2 inhibitors, pramlintide, inhaled insulin, pre-mixed insulins etc.) except subcutaneous basal and bolus insulin within 3 months prior to visit 1
boolean
C0011854 (UMLS CUI [1])
C0020616 (UMLS CUI [2])
C0025598 (UMLS CUI [3])
C1299007 (UMLS CUI [4])
C3273809 (UMLS CUI [5])
C3273807 (UMLS CUI [6])
C0537551 (UMLS CUI [7])
C0021641 (UMLS CUI [8,1])
C0001559 (UMLS CUI [8,2])
C2069057 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0650607 (UMLS CUI [10,2])
C1522438 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0021641 (UMLS CUI [11,2])
C1705509 (UMLS CUI [11,3])
Hypoglycemia Severe Involving Coma | Hypoglycemia Severe Involving Seizure | Hospitalization Required | Patient need for Emergency treatment Hypoglycemia
Item
occurrence of severe hypoglycaemia involving coma and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months prior to visit 1
boolean
C0020615 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0009421 (UMLS CUI [1,4])
C0020615 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C0036572 (UMLS CUI [2,4])
C1708385 (UMLS CUI [3])
C0686904 (UMLS CUI [4,1])
C0013969 (UMLS CUI [4,2])
C0020615 (UMLS CUI [4,3])
Diabetic Ketoacidosis Severe | Finding of pH | Admission to intensive care unit Prolonged | Hospitalization Required
Item
occurence of severe dka (i.e a ph of <7.0 or prolonged intensive care unit admission exceeding two days) requiring hospitalisation within 3 months prior to visit 1
boolean
C0011880 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1304686 (UMLS CUI [2])
C0583239 (UMLS CUI [3,1])
C0439590 (UMLS CUI [3,2])
C1708385 (UMLS CUI [4])
Exclusion Criteria Additional
Item
additional exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial