ID

43612

Descripción

Effects of Aquamin F on NSAID Dose Reduction in Osteoarthritis of the Knee; ODM derived from: https://clinicaltrials.gov/show/NCT00755482

Link

https://clinicaltrials.gov/show/NCT00755482

Palabras clave

Versiones (2)
  1. 10/6/17 10/6/17 -
  2. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Osteoarthritis of the Knee NCT00755482

Inglés

Eligibility Osteoarthritis of the Knee NCT00755482

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects aged 35 to 75, male or female
Descripción

age, gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee according to the modified criteria of the american college of rheumatology 17,18
Descripción

symptomatic moderate to severe knee osteoarthritis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1299393
subjects who present with osteoarthritis of the knee as judged by symptoms and disabilities detectable through published, validated questionnaires or previous diagnosis by a physician
Descripción

osteoarthritis of the knee; Questionnaires; Symptoms | Osteoarthritis, Knee; Prior diagnosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0409959
UMLS CUI [1,2]
C0034394
UMLS CUI [1,3]
C1457887
UMLS CUI [2,1]
C0409959
UMLS CUI [2,2]
C0332132
subjects who are symptomatic with daily or near daily pain and stiffness from osteoarthritis
Descripción

symptomatic with daily or near daily pain and stiffness from osteoarthritis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0231220
UMLS CUI [1,2]
C3841784
UMLS CUI [1,3]
C0409959
subjects who are taking non-steroidal anti-inflammatory drugs (nsaids) prior to study enrollment
Descripción

nsaid

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003211
subjects who are willing to stop nsaids and use acetaminophen for pain management during the trial
Descripción

acetaminophen, stop nsaid

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0000970
UMLS CUI [2,1]
C0850893
UMLS CUI [2,2]
C0003211
subjects with screening womac osteoarthritis index total score (transformed score) of not more than 75
Descripción

womac

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3472647
subjects with ability to comprehend and complete the questionnaires and forms
Descripción

ability to comprehend questionnaires

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1273101
UMLS CUI [1,2]
C0034394
subjects whose schedules permit clinical evaluations every four weeks
Descripción

clinical evaluation, every four weeks

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C1275555
subjects who are willing to stop taking calcium supplements, if any and to restrict consumption of high calcium food to 600mg (two dairy servings) per day
Descripción

stop calcium supplements, restricted consumption of calcium

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3540037
UMLS CUI [1,2]
C0850893
UMLS CUI [2,1]
C0425422
UMLS CUI [2,2]
C0489458
subjects with a high probability of compliance with study procedures and test article consumption
Descripción

compliance behavior

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
subjects willing and able to follow protocol guidelines and schedules and complete diaries
Descripción

protocol compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0525058
subjects who are likely to abstain from taking unathorized supplements or participating in any other clinical trial or experimental treatment during this trial
Descripción

compliance behavior, study subject participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C2348568
subjects with normal gastrointestinal digestion and absorption
Descripción

gastrointestinal digestion and absorption

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0678869
UMLS CUI [1,2]
C3714657
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects who have a history of inflammatory arthritis, gout, pseudogout, paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or hiv infection
Descripción

inflammatory arthritis, gout, pseudogout, paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or hiv infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1562028
UMLS CUI [2]
C0018099
UMLS CUI [3]
C0033802
UMLS CUI [4]
C1368019
UMLS CUI [5]
C0014544
UMLS CUI [6]
C0011854
UMLS CUI [7]
C1868885
UMLS CUI [8]
C0023895
UMLS CUI [9]
C0022658
UMLS CUI [10]
C0006826
UMLS CUI [11]
C0019682
UMLS CUI [12,1]
C0007222
UMLS CUI [12,2]
C0443343
subjects who are non-ambulatory or bedridden due to osteoarthritis
Descripción

subjects who are non-ambulatory or bedridden due to osteoarthritis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0560046
UMLS CUI [1,2]
C0409959
UMLS CUI [2,1]
C0741453
UMLS CUI [2,2]
C0409959
subjects who are dependent on prescription drugs to control pain
Descripción

dependent on prescription drugs to control pain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2128645
subjects on any other clinical trial or experimental treatment in the past 3 months
Descripción

study subject participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
subjects who are pregnant, lactating or at risk of becoming pregnant
Descripción

pregnancy, breast feeding, childbearing potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
subjects who have received : intramuscular corticosteroid injection or systemic corticosteroid administration within 4 weeks prior to study enrollment, intra-articular corticosteroid injection within 2 months prior to study enrollment or intra-articular hyaluronic acid injection within 4 months prior to study enrollment.
Descripción

intramuscular corticosteroid injection, systemic corticosteroid administration, intra-articular corticosteroid injection, intra-articular hyaluronic acid injection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0585373
UMLS CUI [2]
C2825233
UMLS CUI [3]
C2064783
UMLS CUI [4,1]
C0021488
UMLS CUI [4,2]
C0020196
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Similar models

Eligibility Osteoarthritis of the Knee NCT00755482

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
age, gender
Item
subjects aged 35 to 75, male or female
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
symptomatic moderate to severe knee osteoarthritis
Item
subjects diagnosed with symptomatic moderate to severe osteoarthritis of the knee according to the modified criteria of the american college of rheumatology 17,18
boolean
C0409959 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1299393 (UMLS CUI [1,3])
osteoarthritis of the knee; Questionnaires; Symptoms | Osteoarthritis, Knee; Prior diagnosis
Item
subjects who present with osteoarthritis of the knee as judged by symptoms and disabilities detectable through published, validated questionnaires or previous diagnosis by a physician
boolean
C0409959 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0409959 (UMLS CUI [2,1])
C0332132 (UMLS CUI [2,2])
symptomatic with daily or near daily pain and stiffness from osteoarthritis
Item
subjects who are symptomatic with daily or near daily pain and stiffness from osteoarthritis
boolean
C0231220 (UMLS CUI [1,1])
C3841784 (UMLS CUI [1,2])
C0409959 (UMLS CUI [1,3])
nsaid
Item
subjects who are taking non-steroidal anti-inflammatory drugs (nsaids) prior to study enrollment
boolean
C0003211 (UMLS CUI [1])
acetaminophen, stop nsaid
Item
subjects who are willing to stop nsaids and use acetaminophen for pain management during the trial
boolean
C0000970 (UMLS CUI [1])
C0850893 (UMLS CUI [2,1])
C0003211 (UMLS CUI [2,2])
womac
Item
subjects with screening womac osteoarthritis index total score (transformed score) of not more than 75
boolean
C3472647 (UMLS CUI [1])
ability to comprehend questionnaires
Item
subjects with ability to comprehend and complete the questionnaires and forms
boolean
C1273101 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
clinical evaluation, every four weeks
Item
subjects whose schedules permit clinical evaluations every four weeks
boolean
C1261322 (UMLS CUI [1,1])
C1275555 (UMLS CUI [1,2])
stop calcium supplements, restricted consumption of calcium
Item
subjects who are willing to stop taking calcium supplements, if any and to restrict consumption of high calcium food to 600mg (two dairy servings) per day
boolean
C3540037 (UMLS CUI [1,1])
C0850893 (UMLS CUI [1,2])
C0425422 (UMLS CUI [2,1])
C0489458 (UMLS CUI [2,2])
compliance behavior
Item
subjects with a high probability of compliance with study procedures and test article consumption
boolean
C1321605 (UMLS CUI [1])
protocol compliance
Item
subjects willing and able to follow protocol guidelines and schedules and complete diaries
boolean
C0525058 (UMLS CUI [1])
compliance behavior, study subject participation status
Item
subjects who are likely to abstain from taking unathorized supplements or participating in any other clinical trial or experimental treatment during this trial
boolean
C1321605 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
gastrointestinal digestion and absorption
Item
subjects with normal gastrointestinal digestion and absorption
boolean
C0678869 (UMLS CUI [1,1])
C3714657 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
inflammatory arthritis, gout, pseudogout, paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or hiv infection
Item
subjects who have a history of inflammatory arthritis, gout, pseudogout, paget's disease, seizure disorder, insulin dependent diabetes mellitus, uncontrolled hypertension, unstable cardiovascular disease, active hepatic or renal disease, active cancer and/or hiv infection
boolean
C1562028 (UMLS CUI [1])
C0018099 (UMLS CUI [2])
C0033802 (UMLS CUI [3])
C1368019 (UMLS CUI [4])
C0014544 (UMLS CUI [5])
C0011854 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
C0023895 (UMLS CUI [8])
C0022658 (UMLS CUI [9])
C0006826 (UMLS CUI [10])
C0019682 (UMLS CUI [11])
C0007222 (UMLS CUI [12,1])
C0443343 (UMLS CUI [12,2])
subjects who are non-ambulatory or bedridden due to osteoarthritis
Item
subjects who are non-ambulatory or bedridden due to osteoarthritis
boolean
C0560046 (UMLS CUI [1,1])
C0409959 (UMLS CUI [1,2])
C0741453 (UMLS CUI [2,1])
C0409959 (UMLS CUI [2,2])
dependent on prescription drugs to control pain
Item
subjects who are dependent on prescription drugs to control pain
boolean
C2128645 (UMLS CUI [1])
study subject participation status
Item
subjects on any other clinical trial or experimental treatment in the past 3 months
boolean
C2348568 (UMLS CUI [1])
pregnancy, breast feeding, childbearing potential
Item
subjects who are pregnant, lactating or at risk of becoming pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
intramuscular corticosteroid injection, systemic corticosteroid administration, intra-articular corticosteroid injection, intra-articular hyaluronic acid injection
Item
subjects who have received : intramuscular corticosteroid injection or systemic corticosteroid administration within 4 weeks prior to study enrollment, intra-articular corticosteroid injection within 2 months prior to study enrollment or intra-articular hyaluronic acid injection within 4 months prior to study enrollment.
boolean
C0585373 (UMLS CUI [1])
C2825233 (UMLS CUI [2])
C2064783 (UMLS CUI [3])
C0021488 (UMLS CUI [4,1])
C0020196 (UMLS CUI [4,2])
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