ID

31341

Beschreibung

Impact of Switching to Continuous Release Dopamine Agonists; ODM derived from: https://clinicaltrials.gov/show/NCT00465452

Link

https://clinicaltrials.gov/show/NCT00465452

Stichworte

Versionen (1)
  1. 16.08.18 16.08.18 -
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See clinicaltrials.gov

Hochgeladen am

16. August 2018

DOI

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Eligibility Parkinson Disease NCT00465452

Englisch

Eligibility Parkinson Disease NCT00465452

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
each subject must meet all of the following inclusion criteria to qualify for entrance into the study:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subjects who are male or female and are aged 55 and older.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
subjects and/or their legal guardians must be able and willing to give informed consent.
Beschreibung

Informed Consent | Informed Consent Legal Guardians

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0023226
subjects must be on stable doses of pramipexole for greater than 4 weeks duration prior to screening.
Beschreibung

Pramipexole Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0074710
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
subjects who are female must be non-pregnant and non-nursing. women of child-bearing potential (wocbp) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum pregnancy test at screening. women are considered to not be of child-bearing potential if they have been surgically sterilized (physician-documented hysterectomy or tubal ligation) or if they are post-menopausal.
Beschreibung

Gender | Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Contraceptives, Oral | Injectable contraception Long-term | Hormone implant Long-term | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Foam Contraception | Contraceptive Sponge | Intrauterine Devices | Serum pregnancy test negative | Female Sterilization | Hysterectomy | Tubal Ligation | Postmenopausal state

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0006147
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
UMLS CUI [5]
C0009905
UMLS CUI [6,1]
C1262153
UMLS CUI [6,2]
C0443252
UMLS CUI [7,1]
C0848131
UMLS CUI [7,2]
C0443252
UMLS CUI [8,1]
C0004764
UMLS CUI [8,2]
C0205173
UMLS CUI [9]
C0221829
UMLS CUI [10]
C0042241
UMLS CUI [11,1]
C0042254
UMLS CUI [11,2]
C0234007
UMLS CUI [12]
C0183461
UMLS CUI [13]
C0021900
UMLS CUI [14]
C0430061
UMLS CUI [15]
C0015787
UMLS CUI [16]
C0020699
UMLS CUI [17]
C0520483
UMLS CUI [18]
C0232970
subjects must have a clinical diagnosis of parkinson's based on the presence of at least 2 of the 3 cardinal criteria - rest tremor, bradykinesia, rigidity - and no obvious history of head trauma, stroke, infectious, structural, or metabolic abnormality consistent with an alternative diagnosis to parkinson's disease.
Beschreibung

Parkinson Disease | Criteria Main Quantity | Resting Tremor | Bradykinesia | Muscle Rigidity | Craniocerebral Trauma Absent | Cerebrovascular accident Absent | Communicable Disease Absent | STRUCTURAL ANOMALY Absent | Abnormality Metabolic Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0030567
UMLS CUI [2,1]
C0243161
UMLS CUI [2,2]
C1542147
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0234379
UMLS CUI [4]
C0233565
UMLS CUI [5]
C0026837
UMLS CUI [6,1]
C0018674
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0038454
UMLS CUI [7,2]
C0332197
UMLS CUI [8,1]
C0009450
UMLS CUI [8,2]
C0332197
UMLS CUI [9,1]
C0749075
UMLS CUI [9,2]
C0332197
UMLS CUI [10,1]
C1704258
UMLS CUI [10,2]
C0311400
UMLS CUI [10,3]
C0332197
evidence of one or more of the following symptoms: somnolence (ess score ≥ 9), cognitive decline (mmse < 24 ± presence of hallucinations (npi-q), peripheral edema (present by objective physical exam with baseline ankle and calf circumference measured in centimeters).
Beschreibung

Symptoms Quantity | Somnolence ESS Questionnaire | Impaired cognition Mini-mental state examination | Hallucinations Neuropsychiatric Inventory Questionnaire | Peripheral edema Physical Examination | Ankle Circumference Measured | Calf Circumference Measured

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C2830004
UMLS CUI [2,2]
C3541276
UMLS CUI [3,1]
C0338656
UMLS CUI [3,2]
C0451306
UMLS CUI [4,1]
C0018524
UMLS CUI [4,2]
C3539727
UMLS CUI [5,1]
C0085649
UMLS CUI [5,2]
C0031809
UMLS CUI [6,1]
C0003086
UMLS CUI [6,2]
C0332520
UMLS CUI [6,3]
C0444706
UMLS CUI [7,1]
C1305418
UMLS CUI [7,2]
C0332520
UMLS CUI [7,3]
C0444706
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
a subject who meets any of the following criteria will not qualify for the study:
Beschreibung

Criteria Fulfill

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
subjects must not be receiving any treatments for excess somnolence such as amphetamine derivatives, other stimulants or provigil.
Beschreibung

Therapeutic procedure Somnolence | Amphetamine and derivatives | Stimulant | Provigil

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2830004
UMLS CUI [2]
C1445631
UMLS CUI [3]
C0304402
UMLS CUI [4]
C0722882
subjects with actively treated malignancies, clinically significant heart disease, kidney, liver, or pulmonary disorders will be excluded.
Beschreibung

Cancer treatment | Heart Diseases | Kidney Diseases | Liver diseases | Lung diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0023895
UMLS CUI [5]
C0024115
subjects with clinical depression who are not receiving stable doses of antidepressant therapy in excess of 4 weeks duration.
Beschreibung

Depressive disorder | Absence Antidepressant therapy Dose Stable

Datentyp

boolean

Alias
UMLS CUI [1]
C0011581
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1096649
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C0205360
subjects with history of orthostatic hypotension (>30mm drop in systolic pressure and/or >20mm drop in diastolic pressure) associated with syncope.
Beschreibung

Orthostatic Hypotension Associated with Syncope | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020651
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0039070
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
subjects started within the last 14 days on any drug known to substantially inhibit cyp1a2 (e.g., cimetidine, fluvoxamine) or induce cyp1a2 (e.g.omeprazole) (note: subjects already on these agents may be enrolled but must remain on the stable doses of the agents from 14 days prior to the beginning of the study).
Beschreibung

CYP1A2 Inhibitors | Cimetidine | Fluvoxamine | CYP1A2 Inducers | Omeprazole

Datentyp

boolean

Alias
UMLS CUI [1]
C3850068
UMLS CUI [2]
C0008783
UMLS CUI [3]
C0085228
UMLS CUI [4]
C3850050
UMLS CUI [5]
C0028978
subjects who have other medical conditions that are considered clinically unstable or that may compromise the safety of the patient during this study.
Beschreibung

Other medical condition Unstable | Other medical condition compromises Patient safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
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Ähnliche Modelle

Eligibility Parkinson Disease NCT00465452

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Criteria Fulfill
Item
each subject must meet all of the following inclusion criteria to qualify for entrance into the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
subjects who are male or female and are aged 55 and older.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardians
Item
subjects and/or their legal guardians must be able and willing to give informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Pramipexole Dose Stable
Item
subjects must be on stable doses of pramipexole for greater than 4 weeks duration prior to screening.
boolean
C0074710 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Gender | Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Contraceptives, Oral | Injectable contraception Long-term | Hormone implant Long-term | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Foam Contraception | Contraceptive Sponge | Intrauterine Devices | Serum pregnancy test negative | Female Sterilization | Hysterectomy | Tubal Ligation | Postmenopausal state
Item
subjects who are female must be non-pregnant and non-nursing. women of child-bearing potential (wocbp) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum pregnancy test at screening. women are considered to not be of child-bearing potential if they have been surgically sterilized (physician-documented hysterectomy or tubal ligation) or if they are post-menopausal.
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0009905 (UMLS CUI [5])
C1262153 (UMLS CUI [6,1])
C0443252 (UMLS CUI [6,2])
C0848131 (UMLS CUI [7,1])
C0443252 (UMLS CUI [7,2])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C0221829 (UMLS CUI [9])
C0042241 (UMLS CUI [10])
C0042254 (UMLS CUI [11,1])
C0234007 (UMLS CUI [11,2])
C0183461 (UMLS CUI [12])
C0021900 (UMLS CUI [13])
C0430061 (UMLS CUI [14])
C0015787 (UMLS CUI [15])
C0020699 (UMLS CUI [16])
C0520483 (UMLS CUI [17])
C0232970 (UMLS CUI [18])
Parkinson Disease | Criteria Main Quantity | Resting Tremor | Bradykinesia | Muscle Rigidity | Craniocerebral Trauma Absent | Cerebrovascular accident Absent | Communicable Disease Absent | STRUCTURAL ANOMALY Absent | Abnormality Metabolic Absent
Item
subjects must have a clinical diagnosis of parkinson's based on the presence of at least 2 of the 3 cardinal criteria - rest tremor, bradykinesia, rigidity - and no obvious history of head trauma, stroke, infectious, structural, or metabolic abnormality consistent with an alternative diagnosis to parkinson's disease.
boolean
C0030567 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0234379 (UMLS CUI [3])
C0233565 (UMLS CUI [4])
C0026837 (UMLS CUI [5])
C0018674 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0038454 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0009450 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0749075 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C1704258 (UMLS CUI [10,1])
C0311400 (UMLS CUI [10,2])
C0332197 (UMLS CUI [10,3])
Symptoms Quantity | Somnolence ESS Questionnaire | Impaired cognition Mini-mental state examination | Hallucinations Neuropsychiatric Inventory Questionnaire | Peripheral edema Physical Examination | Ankle Circumference Measured | Calf Circumference Measured
Item
evidence of one or more of the following symptoms: somnolence (ess score ≥ 9), cognitive decline (mmse < 24 ± presence of hallucinations (npi-q), peripheral edema (present by objective physical exam with baseline ankle and calf circumference measured in centimeters).
boolean
C1457887 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2830004 (UMLS CUI [2,1])
C3541276 (UMLS CUI [2,2])
C0338656 (UMLS CUI [3,1])
C0451306 (UMLS CUI [3,2])
C0018524 (UMLS CUI [4,1])
C3539727 (UMLS CUI [4,2])
C0085649 (UMLS CUI [5,1])
C0031809 (UMLS CUI [5,2])
C0003086 (UMLS CUI [6,1])
C0332520 (UMLS CUI [6,2])
C0444706 (UMLS CUI [6,3])
C1305418 (UMLS CUI [7,1])
C0332520 (UMLS CUI [7,2])
C0444706 (UMLS CUI [7,3])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
a subject who meets any of the following criteria will not qualify for the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Therapeutic procedure Somnolence | Amphetamine and derivatives | Stimulant | Provigil
Item
subjects must not be receiving any treatments for excess somnolence such as amphetamine derivatives, other stimulants or provigil.
boolean
C0087111 (UMLS CUI [1,1])
C2830004 (UMLS CUI [1,2])
C1445631 (UMLS CUI [2])
C0304402 (UMLS CUI [3])
C0722882 (UMLS CUI [4])
Cancer treatment | Heart Diseases | Kidney Diseases | Liver diseases | Lung diseases
Item
subjects with actively treated malignancies, clinically significant heart disease, kidney, liver, or pulmonary disorders will be excluded.
boolean
C0920425 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
Depressive disorder | Absence Antidepressant therapy Dose Stable
Item
subjects with clinical depression who are not receiving stable doses of antidepressant therapy in excess of 4 weeks duration.
boolean
C0011581 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C1096649 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Orthostatic Hypotension Associated with Syncope | Systolic Pressure | Diastolic blood pressure
Item
subjects with history of orthostatic hypotension (>30mm drop in systolic pressure and/or >20mm drop in diastolic pressure) associated with syncope.
boolean
C0020651 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0039070 (UMLS CUI [1,3])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
CYP1A2 Inhibitors | Cimetidine | Fluvoxamine | CYP1A2 Inducers | Omeprazole
Item
subjects started within the last 14 days on any drug known to substantially inhibit cyp1a2 (e.g., cimetidine, fluvoxamine) or induce cyp1a2 (e.g.omeprazole) (note: subjects already on these agents may be enrolled but must remain on the stable doses of the agents from 14 days prior to the beginning of the study).
boolean
C3850068 (UMLS CUI [1])
C0008783 (UMLS CUI [2])
C0085228 (UMLS CUI [3])
C3850050 (UMLS CUI [4])
C0028978 (UMLS CUI [5])
Other medical condition Unstable | Other medical condition compromises Patient safety
Item
subjects who have other medical conditions that are considered clinically unstable or that may compromise the safety of the patient during this study.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
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