ID

29044

Beschreibung

Choroidal Blood Flow Changes During Dark/Light Transitions in Patients With Insulin-dependent Diabetes Mellitus (IDDM); ODM derived from: https://clinicaltrials.gov/show/NCT00718614

Link

https://clinicaltrials.gov/show/NCT00718614

Stichworte

Versionen (1)
  1. 22.02.18 22.02.18 -
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See clinicaltrials.gov

Hochgeladen am

22. Februar 2018

DOI

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Eligibility Diabetes Mellitus, Type 1 NCT00718614

Englisch

Eligibility Diabetes Mellitus, Type 1 NCT00718614

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
for healthy control subjects:
Beschreibung

Healthy Control

Datentyp

boolean

Alias
UMLS CUI [1]
C2986479
men and women aged over 18 years, matched in regard to age, sex and smoking status
Beschreibung

Age | Match Age Related | Match Gender Related | Match Tobacco use Related

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C1708943
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C0439849
UMLS CUI [3,1]
C1708943
UMLS CUI [3,2]
C0079399
UMLS CUI [3,3]
C0439849
UMLS CUI [4,1]
C1708943
UMLS CUI [4,2]
C0543414
UMLS CUI [4,3]
C0439849
normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Beschreibung

Finding Normal Medical History | Finding Normal Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0243095
UMLS CUI [2,2]
C0205307
UMLS CUI [2,3]
C0031809
normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
Beschreibung

Normal Laboratory Test Result

Datentyp

boolean

Alias
UMLS CUI [1]
C0438214
normal ophthalmic findings, ametropia < 3 dpt for healthy control subjects
Beschreibung

Ophthalmological examination normal | Ametropia Diopters Quantity Healthy Control

Datentyp

boolean

Alias
UMLS CUI [1]
C1112543
UMLS CUI [2,1]
C1527310
UMLS CUI [2,2]
C0439484
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C2986479
for patients with iddm:
Beschreibung

Patients Insulin-Dependent Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0011854
men and women aged over 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Beschreibung

Finding Normal Medical History | Finding Normal Physical Examination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0243095
UMLS CUI [2,2]
C0205307
UMLS CUI [2,3]
C0031809
long standing iddm > 10 years
Beschreibung

Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
mild or moderate to severe non-proliferative diabetic retinopathy (defined according to the mahc)
Beschreibung

Mild non-proliferative diabetic retinopathy | Moderate nonproliferative diabetic retinopathy | Severe nonproliferative diabetic retinopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0730276
UMLS CUI [2]
C0730277
UMLS CUI [3]
C0730278
ametropia < 3 dpt
Beschreibung

Ametropia Diopters Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527310
UMLS CUI [1,2]
C0439484
UMLS CUI [1,3]
C1265611
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any of the following will exclude a healthy subject from the study:
Beschreibung

Exclusion Criteria Healthy Subjects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1708335
regular use of vasoactive medication with may interfere with the study procedure, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
Beschreibung

Vasoactive agent Regular | Interference Clinical Trial Procedure | Alcohol abuse | Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0597639
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0184661
UMLS CUI [3]
C0085762
UMLS CUI [4]
C2348568
symptoms of a clinically relevant illness in the 3 weeks before the first study day
Beschreibung

Symptoms Illness Relevant Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0221423
UMLS CUI [1,3]
C2347946
UMLS CUI [1,4]
C0205210
blood donation during the previous 3 weeks
Beschreibung

Blood Donation

Datentyp

boolean

Alias
UMLS CUI [1]
C0005794
any of the following will exclude a patient with iddm from the study:
Beschreibung

Exclusion Criteria Patients Insulin-Dependent Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0011854
evidence of any relevant retinal or choroidal disease (glaucoma, age related macula degeneration, cataract, history of central retinal artery obstruction or central retinal vein thrombosis)
Beschreibung

Retinal Diseases | Choroid Diseases | Glaucoma | Age related macular degeneration | Cataract | Central Retinal Artery Occlusion | Central retinal vein occlusion

Datentyp

boolean

Alias
UMLS CUI [1]
C0035309
UMLS CUI [2]
C0008521
UMLS CUI [3]
C0017601
UMLS CUI [4]
C0242383
UMLS CUI [5]
C0086543
UMLS CUI [6]
C0007688
UMLS CUI [7]
C0154841
ophthalmological surgery (history of photo laser coagulation, including argon laser trabeculoplasty (alt), trabeculectomy, deep sclerectomy)
Beschreibung

Ophthalmologic Surgical Procedures | Laser photocoagulation | Argon laser trabeculoplasty | Trabeculectomy | Deep sclerectomy

Datentyp

boolean

Alias
UMLS CUI [1]
C0038901
UMLS CUI [2]
C0441510
UMLS CUI [3]
C1319234
UMLS CUI [4]
C0040574
UMLS CUI [5]
C1531790
history of intravitreal injection with anti-proliferative therapy
Beschreibung

Intravitreal Injection | Antineoplastic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C1554888
UMLS CUI [2]
C0003392
need for dialysis
Beschreibung

Patient need for Dialysis

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0686904
UMLS CUI [1,2]
C0011946
non-treated systemic hypertension (spb>150, dbp>95)
Beschreibung

Hypertensive disease untreated | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
evidence of coronary heart disease, cardiomyopathy, stenocardia, congestive heart failure, peripheral occlusive vascular disease, cardiac autonomic neuropathy
Beschreibung

Coronary heart disease | Cardiomyopathy | Angina Pectoris | Congestive heart failure | Peripheral occlusive vascular disorder | Cardiac autonomic neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0878544
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0018802
UMLS CUI [5]
C1385232
UMLS CUI [6]
C1740787
symptoms of a clinically relevant illness in the 3 weeks before the first study day
Beschreibung

Symptoms Illness Relevant Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0221423
UMLS CUI [1,3]
C2347946
UMLS CUI [1,4]
C0205210
blood donation during the previous 3 weeks
Beschreibung

Blood Donation

Datentyp

boolean

Alias
UMLS CUI [1]
C0005794
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Ähnliche Modelle

Eligibility Diabetes Mellitus, Type 1 NCT00718614

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Control
Item
for healthy control subjects:
boolean
C2986479 (UMLS CUI [1])
Age | Match Age Related | Match Gender Related | Match Tobacco use Related
Item
men and women aged over 18 years, matched in regard to age, sex and smoking status
boolean
C0001779 (UMLS CUI [1])
C1708943 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0439849 (UMLS CUI [2,3])
C1708943 (UMLS CUI [3,1])
C0079399 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C1708943 (UMLS CUI [4,1])
C0543414 (UMLS CUI [4,2])
C0439849 (UMLS CUI [4,3])
Finding Normal Medical History | Finding Normal Physical Examination
Item
normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
boolean
C0243095 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0243095 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
Normal Laboratory Test Result
Item
normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
boolean
C0438214 (UMLS CUI [1])
Ophthalmological examination normal | Ametropia Diopters Quantity Healthy Control
Item
normal ophthalmic findings, ametropia < 3 dpt for healthy control subjects
boolean
C1112543 (UMLS CUI [1])
C1527310 (UMLS CUI [2,1])
C0439484 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C2986479 (UMLS CUI [2,4])
Patients Insulin-Dependent Diabetes Mellitus
Item
for patients with iddm:
boolean
C0030705 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Age
Item
men and women aged over 18 years
boolean
C0001779 (UMLS CUI [1])
Finding Normal Medical History | Finding Normal Physical Examination
Item
normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
boolean
C0243095 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0243095 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
Insulin-Dependent Diabetes Mellitus Disease length
Item
long standing iddm > 10 years
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Mild non-proliferative diabetic retinopathy | Moderate nonproliferative diabetic retinopathy | Severe nonproliferative diabetic retinopathy
Item
mild or moderate to severe non-proliferative diabetic retinopathy (defined according to the mahc)
boolean
C0730276 (UMLS CUI [1])
C0730277 (UMLS CUI [2])
C0730278 (UMLS CUI [3])
Ametropia Diopters Quantity
Item
ametropia < 3 dpt
boolean
C1527310 (UMLS CUI [1,1])
C0439484 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Exclusion Criteria Healthy Subjects
Item
any of the following will exclude a healthy subject from the study:
boolean
C0680251 (UMLS CUI [1,1])
C1708335 (UMLS CUI [1,2])
Vasoactive agent Regular | Interference Clinical Trial Procedure | Alcohol abuse | Study Subject Participation Status
Item
regular use of vasoactive medication with may interfere with the study procedure, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
boolean
C0597639 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
C0085762 (UMLS CUI [3])
C2348568 (UMLS CUI [4])
Symptoms Illness Relevant Clinical
Item
symptoms of a clinically relevant illness in the 3 weeks before the first study day
boolean
C1457887 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
Blood Donation
Item
blood donation during the previous 3 weeks
boolean
C0005794 (UMLS CUI [1])
Exclusion Criteria Patients Insulin-Dependent Diabetes Mellitus
Item
any of the following will exclude a patient with iddm from the study:
boolean
C0680251 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0011854 (UMLS CUI [1,3])
Retinal Diseases | Choroid Diseases | Glaucoma | Age related macular degeneration | Cataract | Central Retinal Artery Occlusion | Central retinal vein occlusion
Item
evidence of any relevant retinal or choroidal disease (glaucoma, age related macula degeneration, cataract, history of central retinal artery obstruction or central retinal vein thrombosis)
boolean
C0035309 (UMLS CUI [1])
C0008521 (UMLS CUI [2])
C0017601 (UMLS CUI [3])
C0242383 (UMLS CUI [4])
C0086543 (UMLS CUI [5])
C0007688 (UMLS CUI [6])
C0154841 (UMLS CUI [7])
Ophthalmologic Surgical Procedures | Laser photocoagulation | Argon laser trabeculoplasty | Trabeculectomy | Deep sclerectomy
Item
ophthalmological surgery (history of photo laser coagulation, including argon laser trabeculoplasty (alt), trabeculectomy, deep sclerectomy)
boolean
C0038901 (UMLS CUI [1])
C0441510 (UMLS CUI [2])
C1319234 (UMLS CUI [3])
C0040574 (UMLS CUI [4])
C1531790 (UMLS CUI [5])
Intravitreal Injection | Antineoplastic Agents
Item
history of intravitreal injection with anti-proliferative therapy
boolean
C1554888 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
Patient need for Dialysis
Item
need for dialysis
boolean
C0686904 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
Hypertensive disease untreated | Systolic Pressure | Diastolic blood pressure
Item
non-treated systemic hypertension (spb>150, dbp>95)
boolean
C0020538 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Coronary heart disease | Cardiomyopathy | Angina Pectoris | Congestive heart failure | Peripheral occlusive vascular disorder | Cardiac autonomic neuropathy
Item
evidence of coronary heart disease, cardiomyopathy, stenocardia, congestive heart failure, peripheral occlusive vascular disease, cardiac autonomic neuropathy
boolean
C0010068 (UMLS CUI [1])
C0878544 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C1385232 (UMLS CUI [5])
C1740787 (UMLS CUI [6])
Symptoms Illness Relevant Clinical
Item
symptoms of a clinically relevant illness in the 3 weeks before the first study day
boolean
C1457887 (UMLS CUI [1,1])
C0221423 (UMLS CUI [1,2])
C2347946 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
Blood Donation
Item
blood donation during the previous 3 weeks
boolean
C0005794 (UMLS CUI [1])
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