ID

36787

Beschreibung

CNS Uptake of Intranasal Glutathione; ODM derived from: https://clinicaltrials.gov/show/NCT02324426

Link

https://clinicaltrials.gov/show/NCT02324426

Stichworte

Versionen (1)
  1. 08.06.19 08.06.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

8. Juni 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02324426

Englisch

Eligibility Parkinson's Disease NCT02324426

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ability to attend a 3 hour study visit in seattle, wa.
Beschreibung

Ability Clinical Trial Visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0008952
ability to read and speak english.
Beschreibung

Able to read English Language | Able to speak English Language

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0586740
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0564215
UMLS CUI [2,2]
C0376245
have three or more of the required positive criteria for pd from step 3 of the uk brain bank diagnostic criteria for parkinson's disease.
Beschreibung

Diagnostic criteria Quantity Parkinson Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679228
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0030567
a modified hoehn & yahr stage 2-3. (bilateral disease, not severely disabled.)
Beschreibung

Modified Hoehn and Yahr Staging | Bilateral Disease | Disability severe Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C3639878
UMLS CUI [2]
C1511113
UMLS CUI [3,1]
C0424990
UMLS CUI [3,2]
C0332197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contra-indication to magnetic resonance imaging, including pacemaker, pacemaker wires, aneurysm clip, or any electronic implant, weight over 136 kg (300 lb), metal embedded in soft tissue or in the eye, prosthetic eye, claustrophobia, substance abuse, use of recreational drugs, pregnancy, or other medical contraindications.
Beschreibung

Medical contraindication Magnetic Resonance Imaging | Artificial cardiac pacemaker | Pacemaker Wire | Aneurysm clip | Implants Electronic | Increased body weight | Metal Soft tissue | Metal foreign body in eye region | Ocular Prosthesis | Claustrophobia | Substance Use Disorders | Use of Recreational Drugs | Pregnancy | Medical contraindication Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0030163
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C4522306
UMLS CUI [4]
C0179977
UMLS CUI [5,1]
C0021102
UMLS CUI [5,2]
C0013850
UMLS CUI [6]
C0043094
UMLS CUI [7,1]
C0025552
UMLS CUI [7,2]
C0225317
UMLS CUI [8]
C0562528
UMLS CUI [9]
C0015417
UMLS CUI [10]
C0008909
UMLS CUI [11]
C0038586
UMLS CUI [12,1]
C1524063
UMLS CUI [12,2]
C0242508
UMLS CUI [13]
C0032961
UMLS CUI [14,1]
C1301624
UMLS CUI [14,2]
C1524062
a history of epilepsy, stroke, brain surgery, or structural brain disease.
Beschreibung

Epilepsy | Cerebrovascular accident | Operation on brain | Brain Disease structural

Datentyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0195775
UMLS CUI [4,1]
C0006111
UMLS CUI [4,2]
C0678594
the presence of other serious illnesses (discretion of study clinician, e.g. concurrent cancer treatment.)
Beschreibung

Comorbidity Serious | Cancer treatment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0920425
pregnant.
Beschreibung

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
a history of sulfur sensitivity, e.g. reaction n-acetylcysteine, msm, same.
Beschreibung

Sulfur allergy | Allergic Reaction Acetylcysteine | Allergic Reaction MSM | Allergic Reaction SAMe

Datentyp

boolean

Alias
UMLS CUI [1]
C0571095
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0001047
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C0058231
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C0036002
a recent history of asthma.
Beschreibung

Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
supplementation with glutathione (oral, intravenous, intranasal, or nebulized) or the glutathione precursor, n-acetylcysteine, for six months prior to baseline study visit.
Beschreibung

Glutathione Supplementation Oral | Glutathione Supplementation Intravenous | Glutathione Supplementation intranasal | Glutathione Supplementation nebulized | Glutathione Precursor | Acetylcysteine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0017817
UMLS CUI [1,2]
C0242297
UMLS CUI [1,3]
C1527415
UMLS CUI [2,1]
C0017817
UMLS CUI [2,2]
C0242297
UMLS CUI [2,3]
C1522726
UMLS CUI [3,1]
C0017817
UMLS CUI [3,2]
C0242297
UMLS CUI [3,3]
C1522019
UMLS CUI [4,1]
C0017817
UMLS CUI [4,2]
C0242297
UMLS CUI [4,3]
C1549541
UMLS CUI [5,1]
C0017817
UMLS CUI [5,2]
C1709634
UMLS CUI [6]
C0001047
history of sensitivity to sulfur containing medications/ supplements, i.e. nac, msm.
Beschreibung

Hypersensitivity Pharmaceutical Preparations Containing Sulfur | Hypersensitivity Supplements Containing Sulfur | Acetylcysteine allergy | Hypersensitivity Methylsulfonylmethane

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0332256
UMLS CUI [1,4]
C0038774
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0242295
UMLS CUI [2,3]
C0332256
UMLS CUI [2,4]
C0038774
UMLS CUI [3]
C0571014
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0058231
current drug or alcohol use or dependence.
Beschreibung

Substance Use Disorders | Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0038580
inability/unwillingness to provide informed consent. (e.g. diagnosis of dementia, confusion about study goals or participation.)
Beschreibung

Informed Consent Unable | Informed Consent Unwilling | Dementia | Confusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
UMLS CUI [3]
C0497327
UMLS CUI [4]
C0009676
acute infection (e.g. upper respiratory, dermal) in the previous 30 days.
Beschreibung

Communicable Disease | Upper Respiratory Infection | Skin Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0041912
UMLS CUI [3]
C0037278
diagnosis of any mental illness, ever. (mental illness has been associated with glutathione depletion.)
Beschreibung

Mental disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
diagnosis of any chronic disease, ever. (e.g. hep c, autoimmune disease, etc.)
Beschreibung

Chronic disease | Hepatitis C | Autoimmune Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0008679
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0004364
head tremor or head dyskinesia that cannot be comfortably controlled for 90 minutes.
Beschreibung

Head tremor | Head Dyskinesia | Control Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1]
C0239882
UMLS CUI [2,1]
C0018670
UMLS CUI [2,2]
C0013384
UMLS CUI [3,1]
C0243148
UMLS CUI [3,2]
C1272705
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Ähnliche Modelle

Eligibility Parkinson's Disease NCT02324426

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 years.
boolean
C0001779 (UMLS CUI [1])
Ability Clinical Trial Visit
Item
ability to attend a 3 hour study visit in seattle, wa.
boolean
C0085732 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0008952 (UMLS CUI [1,3])
Able to read English Language | Able to speak English Language
Item
ability to read and speak english.
boolean
C0586740 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0564215 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
Diagnostic criteria Quantity Parkinson Disease
Item
have three or more of the required positive criteria for pd from step 3 of the uk brain bank diagnostic criteria for parkinson's disease.
boolean
C0679228 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0030567 (UMLS CUI [1,3])
Modified Hoehn and Yahr Staging | Bilateral Disease | Disability severe Absent
Item
a modified hoehn & yahr stage 2-3. (bilateral disease, not severely disabled.)
boolean
C3639878 (UMLS CUI [1])
C1511113 (UMLS CUI [2])
C0424990 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Magnetic Resonance Imaging | Artificial cardiac pacemaker | Pacemaker Wire | Aneurysm clip | Implants Electronic | Increased body weight | Metal Soft tissue | Metal foreign body in eye region | Ocular Prosthesis | Claustrophobia | Substance Use Disorders | Use of Recreational Drugs | Pregnancy | Medical contraindication Additional
Item
any contra-indication to magnetic resonance imaging, including pacemaker, pacemaker wires, aneurysm clip, or any electronic implant, weight over 136 kg (300 lb), metal embedded in soft tissue or in the eye, prosthetic eye, claustrophobia, substance abuse, use of recreational drugs, pregnancy, or other medical contraindications.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C4522306 (UMLS CUI [3,2])
C0179977 (UMLS CUI [4])
C0021102 (UMLS CUI [5,1])
C0013850 (UMLS CUI [5,2])
C0043094 (UMLS CUI [6])
C0025552 (UMLS CUI [7,1])
C0225317 (UMLS CUI [7,2])
C0562528 (UMLS CUI [8])
C0015417 (UMLS CUI [9])
C0008909 (UMLS CUI [10])
C0038586 (UMLS CUI [11])
C1524063 (UMLS CUI [12,1])
C0242508 (UMLS CUI [12,2])
C0032961 (UMLS CUI [13])
C1301624 (UMLS CUI [14,1])
C1524062 (UMLS CUI [14,2])
Epilepsy | Cerebrovascular accident | Operation on brain | Brain Disease structural
Item
a history of epilepsy, stroke, brain surgery, or structural brain disease.
boolean
C0014544 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0195775 (UMLS CUI [3])
C0006111 (UMLS CUI [4,1])
C0678594 (UMLS CUI [4,2])
Comorbidity Serious | Cancer treatment
Item
the presence of other serious illnesses (discretion of study clinician, e.g. concurrent cancer treatment.)
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2])
Pregnancy
Item
pregnant.
boolean
C0032961 (UMLS CUI [1])
Sulfur allergy | Allergic Reaction Acetylcysteine | Allergic Reaction MSM | Allergic Reaction SAMe
Item
a history of sulfur sensitivity, e.g. reaction n-acetylcysteine, msm, same.
boolean
C0571095 (UMLS CUI [1])
C1527304 (UMLS CUI [2,1])
C0001047 (UMLS CUI [2,2])
C1527304 (UMLS CUI [3,1])
C0058231 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C0036002 (UMLS CUI [4,2])
Asthma
Item
a recent history of asthma.
boolean
C0004096 (UMLS CUI [1])
Glutathione Supplementation Oral | Glutathione Supplementation Intravenous | Glutathione Supplementation intranasal | Glutathione Supplementation nebulized | Glutathione Precursor | Acetylcysteine
Item
supplementation with glutathione (oral, intravenous, intranasal, or nebulized) or the glutathione precursor, n-acetylcysteine, for six months prior to baseline study visit.
boolean
C0017817 (UMLS CUI [1,1])
C0242297 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C0017817 (UMLS CUI [2,1])
C0242297 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
C0017817 (UMLS CUI [3,1])
C0242297 (UMLS CUI [3,2])
C1522019 (UMLS CUI [3,3])
C0017817 (UMLS CUI [4,1])
C0242297 (UMLS CUI [4,2])
C1549541 (UMLS CUI [4,3])
C0017817 (UMLS CUI [5,1])
C1709634 (UMLS CUI [5,2])
C0001047 (UMLS CUI [6])
Hypersensitivity Pharmaceutical Preparations Containing Sulfur | Hypersensitivity Supplements Containing Sulfur | Acetylcysteine allergy | Hypersensitivity Methylsulfonylmethane
Item
history of sensitivity to sulfur containing medications/ supplements, i.e. nac, msm.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0332256 (UMLS CUI [1,3])
C0038774 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0242295 (UMLS CUI [2,2])
C0332256 (UMLS CUI [2,3])
C0038774 (UMLS CUI [2,4])
C0571014 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0058231 (UMLS CUI [4,2])
Substance Use Disorders | Substance Dependence
Item
current drug or alcohol use or dependence.
boolean
C0038586 (UMLS CUI [1])
C0038580 (UMLS CUI [2])
Informed Consent Unable | Informed Consent Unwilling | Dementia | Confusion
Item
inability/unwillingness to provide informed consent. (e.g. diagnosis of dementia, confusion about study goals or participation.)
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0497327 (UMLS CUI [3])
C0009676 (UMLS CUI [4])
Communicable Disease | Upper Respiratory Infection | Skin Infection
Item
acute infection (e.g. upper respiratory, dermal) in the previous 30 days.
boolean
C0009450 (UMLS CUI [1])
C0041912 (UMLS CUI [2])
C0037278 (UMLS CUI [3])
Mental disorders
Item
diagnosis of any mental illness, ever. (mental illness has been associated with glutathione depletion.)
boolean
C0004936 (UMLS CUI [1])
Chronic disease | Hepatitis C | Autoimmune Diseases
Item
diagnosis of any chronic disease, ever. (e.g. hep c, autoimmune disease, etc.)
boolean
C0008679 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0004364 (UMLS CUI [3])
Head tremor | Head Dyskinesia | Control Unsuccessful
Item
head tremor or head dyskinesia that cannot be comfortably controlled for 90 minutes.
boolean
C0239882 (UMLS CUI [1])
C0018670 (UMLS CUI [2,1])
C0013384 (UMLS CUI [2,2])
C0243148 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
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