ID

18604

Beschrijving

Effects of Osteoarthritis Pain, Morphine, and Placebo on Neuroendocrine Function in Men; ODM derived from: https://clinicaltrials.gov/show/NCT00088296

Link

https://clinicaltrials.gov/show/NCT00088296

Trefwoorden

Versies (1)
  1. 12-11-16 12-11-16 -
Geüploaded op

12 november 2016

DOI

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Creative Commons BY 4.0
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Eligibility Osteoarthritis NCT00088296

Engels

Eligibility Osteoarthritis NCT00088296

1 Formulieren  
Criteria
Beschrijving

Criteria

1. clinical evidence of chronic oa by history and examination in a major joint or the spine.
Beschrijving

Chronic osteoarthritis Joint Major Evidence of | Chronic osteoarthritis Vertebral column Evidence of

Datatype

boolean

Alias
UMLS CUI [1,1]
C0263778
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C0205164
UMLS CUI [1,4]
C0332120
UMLS CUI [2,1]
C0263778
UMLS CUI [2,2]
C0037949
UMLS CUI [2,3]
C0332120
1. pain level of 4/10 or greater on a scale of 0 to 10
Beschrijving

Pain level | Numeric Pain Scale

Datatype

boolean

Alias
UMLS CUI [1]
C0518087
UMLS CUI [2]
C1518471
2. pain for a duration of 3 months or longer present at least 5 out of 7 days a week
Beschrijving

Pain Duration | Pain Frequency

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0030193
UMLS CUI [2,2]
C0376249
3. radiographic evidence of moderate to severe oa in the involved joint based on the kellgren and lawrence scoring scale.
Beschrijving

Osteoarthritis Moderate Joint Involved | Osteoarthritis Severe Joint Involved | Kellgren-Lawrence score

Datatype

boolean

Alias
UMLS CUI [1,1]
C0029408
UMLS CUI [1,2]
C0205081
UMLS CUI [1,3]
C0022417
UMLS CUI [1,4]
C1314939
UMLS CUI [2,1]
C0029408
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0022417
UMLS CUI [2,4]
C1314939
UMLS CUI [3]
C3177117
2. age between 30-65 at study entry
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
3. men of all ethnicities
Beschrijving

Gender | Ethnic group All

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0015031
UMLS CUI [2,2]
C0444868
4. ability to understand the study measures and mentally capable of giving consent to participate in the study (based on an 8th grade education level)
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
5. willingness to refrain from taking opioids other than as dictated by the study design
Beschrijving

opioid use Abstinence Willing | MS Contin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0240602
UMLS CUI [1,2]
C3843422
UMLS CUI [1,3]
C0600109
UMLS CUI [2]
C0700786
exclusion criteria :
Beschrijving

Exclusion Criteria

Datatype

boolean

Alias
UMLS CUI [1]
C0680251
1. impaired pulmonary, renal, hepatic, cardiovascular or endocrine-metabolic function; major coexisting medical condition such as cancer, chronic obstructive pulmonary disease and severe hepatic and renal dysfunction
Beschrijving

Pulmonary function Impaired | Renal Insufficiency | Liver Dysfunction | cardiovascular system function Impaired | Limited endocrine or metabolic function | Comorbidity Major | Malignant Neoplasms | Chronic Obstructive Airway Disease | Liver Dysfunction Severe | Renal dysfunction Severe

Datatype

boolean

Alias
UMLS CUI [1,1]
C0231921
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0086565
UMLS CUI [4,1]
C0678859
UMLS CUI [4,2]
C0221099
UMLS CUI [5]
C0497559
UMLS CUI [6,1]
C0009488
UMLS CUI [6,2]
C0205164
UMLS CUI [7]
C0006826
UMLS CUI [8]
C0024117
UMLS CUI [9,1]
C0086565
UMLS CUI [9,2]
C0205082
UMLS CUI [10,1]
C3279454
UMLS CUI [10,2]
C0205082
2. primary or secondary endocrine disease such as diabetes or cushing's syndrome
Beschrijving

Endocrine System Disease Primary | Endocrine System Disease Secondary | Diabetes Mellitus | Cushing Syndrome

Datatype

boolean

Alias
UMLS CUI [1,1]
C0014130
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C0014130
UMLS CUI [2,2]
C0175668
UMLS CUI [3]
C0011849
UMLS CUI [4]
C0010481
3. prostatic disease requiring usage of urological medications
Beschrijving

Prostatic Disease Requirement Urological Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C0033575
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C2064919
4. presence of sexual dysfunction defined as lack of libido, impotence or erectile abnormalities.
Beschrijving

Sexual Dysfunction | Lack of libido | Erectile dysfunction | Erectile abnormalities

Datatype

boolean

Alias
UMLS CUI [1]
C0549622
UMLS CUI [2]
C2981158
UMLS CUI [3]
C0242350
UMLS CUI [4]
C4022003
5. current symptoms of coronary artery disease
Beschrijving

Coronary Artery Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1956346
6. presence of ra, or other types of inflammatory arthritis
Beschrijving

Rheumatoid Arthritis | Arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0003864
7. use of systemic corticosteroids in the two months before screening and study entry
Beschrijving

systemic steroids

Datatype

boolean

Alias
UMLS CUI [1]
C2825233
8. alcohol abuse up to a year prior to study enrollment
Beschrijving

Alcohol abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0085762
9. usage of any recreational drugs
Beschrijving

Drug abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0013146
10. history of narcotic abuse at any time in the past
Beschrijving

Narcotic Abuse

Datatype

boolean

Alias
UMLS CUI [1]
C0524661
11. major depression whether successfully or unsuccessfully treated or diagnosed at the time of study screening based on a score of greater than or equal to 20 on the beck depression inventory
Beschrijving

Major Depressive Disorder | Beck depression inventory

Datatype

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0451022
12. hct less than 35; anemia or bleeding disorder
Beschrijving

Hematocrit level | Anemia | Blood Coagulation Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0518014
UMLS CUI [2]
C0002871
UMLS CUI [3]
C0005779
13. allergy to morphine
Beschrijving

Morphine allergy

Datatype

boolean

Alias
UMLS CUI [1]
C0570528
14. current or past history of fibromyalgia as described by wolfe f et al., (1990) (a minimum of 12 out of 19 points of tenderness must be present to satisfy criteria for fibromyalgia)
Beschrijving

Fibromyalgia | Tenderness | Tender Points Minimum

Datatype

boolean

Alias
UMLS CUI [1]
C0016053
UMLS CUI [2]
C0234233
UMLS CUI [3,1]
C1704505
UMLS CUI [3,2]
C1524031
15. cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits
Beschrijving

Impaired cognition | Informed Consent Unable | Protocol Compliance Unable

Datatype

boolean

Alias
UMLS CUI [1]
C0338656
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
UMLS CUI [3,1]
C0525058
UMLS CUI [3,2]
C1299582
16. age 29 years or less due to rarity of oa in this age group
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
17. body mass index (bmi) greater than 30kg/m(2) and bmi less than 20kg/m(2)
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
usage of nonsteroidal anti-inflammatory drugs (nsaids) will be allowed at study entry and during the conduct of the study. patients will be asked to refrain from using muscle relaxers, other opioids apart from the study drug (ms contin), aed's (anti-epileptic drugs), tcas (tricyclic antidepressants), ssris (selective serotonin reuptake inhibitors) and benzodiazepines for pain control during part ii and iii. patients will also be asked to refrain from having local joint injections with steroids or other agents. patients will be queried regarding their use of complementary and/or alternative medicine (cam) treatments (e.g. acupuncture, chiropractic manipulations, herbs and botanicals, and mind-body interventions) at the start of the study and will be counseled against beginning cam treatments during the study protocol. starting any of these treatments during the study will be considered a study violation. the only exception will be for glucosamine and/or chondroitin.
Beschrijving

Anti-Inflammatory Agents, Non-Steroidal | Muscle relaxants | Opioids | MS Contin | Antiepileptic Agents | Tricyclic Antidepressive Agents | Selective Serotonin Reuptake Inhibitors | Benzodiazepines Pain control | Injection of steroid into joint | complementary and alternative therapy | Acupuncture | Chiropractic manipulation | Medicinal Herbs | Botanical | Mind-Body Medicine | Glucosamine | Chondroitin

Datatype

boolean

Alias
UMLS CUI [1]
C0003211
UMLS CUI [2]
C0358430
UMLS CUI [3]
C0242402
UMLS CUI [4]
C0700786
UMLS CUI [5]
C0003299
UMLS CUI [6]
C0003290
UMLS CUI [7]
C0360105
UMLS CUI [8,1]
C0005064
UMLS CUI [8,2]
C1304888
UMLS CUI [9]
C0394848
UMLS CUI [10]
C1456846
UMLS CUI [11]
C0394664
UMLS CUI [12]
C0600577
UMLS CUI [13]
C0025125
UMLS CUI [14]
C1456557
UMLS CUI [15]
C1513305
UMLS CUI [16]
C0017718
UMLS CUI [17]
C0008454
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Similar models

Eligibility Osteoarthritis NCT00088296

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Chronic osteoarthritis Joint Major Evidence of | Chronic osteoarthritis Vertebral column Evidence of
Item
1. clinical evidence of chronic oa by history and examination in a major joint or the spine.
boolean
C0263778 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0332120 (UMLS CUI [1,4])
C0263778 (UMLS CUI [2,1])
C0037949 (UMLS CUI [2,2])
C0332120 (UMLS CUI [2,3])
Pain level | Numeric Pain Scale
Item
1. pain level of 4/10 or greater on a scale of 0 to 10
boolean
C0518087 (UMLS CUI [1])
C1518471 (UMLS CUI [2])
Pain Duration | Pain Frequency
Item
2. pain for a duration of 3 months or longer present at least 5 out of 7 days a week
boolean
C0030193 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2,1])
C0376249 (UMLS CUI [2,2])
Osteoarthritis Moderate Joint Involved | Osteoarthritis Severe Joint Involved | Kellgren-Lawrence score
Item
3. radiographic evidence of moderate to severe oa in the involved joint based on the kellgren and lawrence scoring scale.
boolean
C0029408 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0022417 (UMLS CUI [1,3])
C1314939 (UMLS CUI [1,4])
C0029408 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0022417 (UMLS CUI [2,3])
C1314939 (UMLS CUI [2,4])
C3177117 (UMLS CUI [3])
Age
Item
2. age between 30-65 at study entry
boolean
C0001779 (UMLS CUI [1])
Gender | Ethnic group All
Item
3. men of all ethnicities
boolean
C0079399 (UMLS CUI [1])
C0015031 (UMLS CUI [2,1])
C0444868 (UMLS CUI [2,2])
Informed Consent
Item
4. ability to understand the study measures and mentally capable of giving consent to participate in the study (based on an 8th grade education level)
boolean
C0021430 (UMLS CUI [1])
opioid use Abstinence Willing | MS Contin
Item
5. willingness to refrain from taking opioids other than as dictated by the study design
boolean
C0240602 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0700786 (UMLS CUI [2])
Exclusion Criteria
Item
exclusion criteria :
boolean
C0680251 (UMLS CUI [1])
Pulmonary function Impaired | Renal Insufficiency | Liver Dysfunction | cardiovascular system function Impaired | Limited endocrine or metabolic function | Comorbidity Major | Malignant Neoplasms | Chronic Obstructive Airway Disease | Liver Dysfunction Severe | Renal dysfunction Severe
Item
1. impaired pulmonary, renal, hepatic, cardiovascular or endocrine-metabolic function; major coexisting medical condition such as cancer, chronic obstructive pulmonary disease and severe hepatic and renal dysfunction
boolean
C0231921 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C0678859 (UMLS CUI [4,1])
C0221099 (UMLS CUI [4,2])
C0497559 (UMLS CUI [5])
C0009488 (UMLS CUI [6,1])
C0205164 (UMLS CUI [6,2])
C0006826 (UMLS CUI [7])
C0024117 (UMLS CUI [8])
C0086565 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C3279454 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
Endocrine System Disease Primary | Endocrine System Disease Secondary | Diabetes Mellitus | Cushing Syndrome
Item
2. primary or secondary endocrine disease such as diabetes or cushing's syndrome
boolean
C0014130 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C0014130 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
C0011849 (UMLS CUI [3])
C0010481 (UMLS CUI [4])
Prostatic Disease Requirement Urological Agents
Item
3. prostatic disease requiring usage of urological medications
boolean
C0033575 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C2064919 (UMLS CUI [1,3])
Sexual Dysfunction | Lack of libido | Erectile dysfunction | Erectile abnormalities
Item
4. presence of sexual dysfunction defined as lack of libido, impotence or erectile abnormalities.
boolean
C0549622 (UMLS CUI [1])
C2981158 (UMLS CUI [2])
C0242350 (UMLS CUI [3])
C4022003 (UMLS CUI [4])
Coronary Artery Disease
Item
5. current symptoms of coronary artery disease
boolean
C1956346 (UMLS CUI [1])
Rheumatoid Arthritis | Arthritis
Item
6. presence of ra, or other types of inflammatory arthritis
boolean
C0003873 (UMLS CUI [1])
C0003864 (UMLS CUI [2])
systemic steroids
Item
7. use of systemic corticosteroids in the two months before screening and study entry
boolean
C2825233 (UMLS CUI [1])
Alcohol abuse
Item
8. alcohol abuse up to a year prior to study enrollment
boolean
C0085762 (UMLS CUI [1])
Drug abuse
Item
9. usage of any recreational drugs
boolean
C0013146 (UMLS CUI [1])
Narcotic Abuse
Item
10. history of narcotic abuse at any time in the past
boolean
C0524661 (UMLS CUI [1])
Major Depressive Disorder | Beck depression inventory
Item
11. major depression whether successfully or unsuccessfully treated or diagnosed at the time of study screening based on a score of greater than or equal to 20 on the beck depression inventory
boolean
C1269683 (UMLS CUI [1])
C0451022 (UMLS CUI [2])
Hematocrit level | Anemia | Blood Coagulation Disorder
Item
12. hct less than 35; anemia or bleeding disorder
boolean
C0518014 (UMLS CUI [1])
C0002871 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
Morphine allergy
Item
13. allergy to morphine
boolean
C0570528 (UMLS CUI [1])
Fibromyalgia | Tenderness | Tender Points Minimum
Item
14. current or past history of fibromyalgia as described by wolfe f et al., (1990) (a minimum of 12 out of 19 points of tenderness must be present to satisfy criteria for fibromyalgia)
boolean
C0016053 (UMLS CUI [1])
C0234233 (UMLS CUI [2])
C1704505 (UMLS CUI [3,1])
C1524031 (UMLS CUI [3,2])
Impaired cognition | Informed Consent Unable | Protocol Compliance Unable
Item
15. cognitive impairment such that the individual is unable to give informed consent, complete study data collection tools or required study visits
boolean
C0338656 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
Age
Item
16. age 29 years or less due to rarity of oa in this age group
boolean
C0001779 (UMLS CUI [1])
Body mass index
Item
17. body mass index (bmi) greater than 30kg/m(2) and bmi less than 20kg/m(2)
boolean
C1305855 (UMLS CUI [1])
Anti-Inflammatory Agents, Non-Steroidal | Muscle relaxants | Opioids | MS Contin | Antiepileptic Agents | Tricyclic Antidepressive Agents | Selective Serotonin Reuptake Inhibitors | Benzodiazepines Pain control | Injection of steroid into joint | complementary and alternative therapy | Acupuncture | Chiropractic manipulation | Medicinal Herbs | Botanical | Mind-Body Medicine | Glucosamine | Chondroitin
Item
usage of nonsteroidal anti-inflammatory drugs (nsaids) will be allowed at study entry and during the conduct of the study. patients will be asked to refrain from using muscle relaxers, other opioids apart from the study drug (ms contin), aed's (anti-epileptic drugs), tcas (tricyclic antidepressants), ssris (selective serotonin reuptake inhibitors) and benzodiazepines for pain control during part ii and iii. patients will also be asked to refrain from having local joint injections with steroids or other agents. patients will be queried regarding their use of complementary and/or alternative medicine (cam) treatments (e.g. acupuncture, chiropractic manipulations, herbs and botanicals, and mind-body interventions) at the start of the study and will be counseled against beginning cam treatments during the study protocol. starting any of these treatments during the study will be considered a study violation. the only exception will be for glucosamine and/or chondroitin.
boolean
C0003211 (UMLS CUI [1])
C0358430 (UMLS CUI [2])
C0242402 (UMLS CUI [3])
C0700786 (UMLS CUI [4])
C0003299 (UMLS CUI [5])
C0003290 (UMLS CUI [6])
C0360105 (UMLS CUI [7])
C0005064 (UMLS CUI [8,1])
C1304888 (UMLS CUI [8,2])
C0394848 (UMLS CUI [9])
C1456846 (UMLS CUI [10])
C0394664 (UMLS CUI [11])
C0600577 (UMLS CUI [12])
C0025125 (UMLS CUI [13])
C1456557 (UMLS CUI [14])
C1513305 (UMLS CUI [15])
C0017718 (UMLS CUI [16])
C0008454 (UMLS CUI [17])
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