ID

34988

Beschreibung

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Stichworte

Versionen (1)
  1. 07.02.19 07.02.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

7. Februar 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

Englisch

Screening - RLS Diagnostic Clinical Interview

1 Formulare  
Final Diagnosis
Beschreibung

Final Diagnosis

Alias
UMLS CUI-1
C1546485
Final Diagnosis:
Beschreibung

Final Diagnosis:

Datentyp

integer

Alias
UMLS CUI [1]
C1546485
Cause for Final Diagnosis:
Beschreibung

Cause for Final Diagnosis:

Datentyp

text

Alias
UMLS CUI [1,1]
C1546485
UMLS CUI [1,2]
C0085978
Please comlpete the follwing questions:
Beschreibung

Please comlpete the follwing questions:

Alias
UMLS CUI-1
C1522634
UMLS CUI-2
C0205197
1. Have you ever had unpleasant or uncomfortable feelings in your legs that occurred mainly while you were either sitting or lying down?
Beschreibung

If no, go to #3

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C4062607
UMLS CUI [1,4]
C0277814
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C4062607
UMLS CUI [2,4]
C0444334
2. Are these feelings painful rather than just uncomfortable?
Beschreibung

2. Are these feelings painful rather than just uncomfortable?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0030193
2a. How would you describe these feelings or sensations?
Beschreibung

2a. How would you describe these feelings or sensations?

Datentyp

text

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0678257
3. Have you ever felt the need or urge to move your legs that occurred mainly while you were either sitting or lying down?
Beschreibung

If yes, go to #3a. If no, go to #4.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1863322
UMLS CUI [1,2]
C0277814
UMLS CUI [2,1]
C1863322
UMLS CUI [2,2]
C0444334
3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
Beschreibung

3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?

Datentyp

boolean

Alias
UMLS CUI [1]
C1863322
3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
Beschreibung

Mark One If no to both questions #1 and #3, go to #15.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0558185
UMLS CUI [1,4]
C1280500
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C1948035
UMLS CUI [2,4]
C1280500
4. Do you think these feelings in your legs are due to a Charlie-horse or muscle cramp?
Beschreibung

If yes, go to #4a. If no, go to #5.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0277823
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C0026821
4a. Are these feelings always due to a Charlie-horse or muscle cramp?
Beschreibung

If yes, go to #15. If no, go to #5.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0277823
UMLS CUI [1,4]
C2003902
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C0026821
UMLS CUI [2,4]
C2003902
5. While you are actually walking around, do you get any relief from these feelings?
Beschreibung

if no, go to #6 if don’t know, go to #5c

Datentyp

integer

Alias
UMLS CUI [1,1]
C0080331
UMLS CUI [1,2]
C0564405
UMLS CUI [1,3]
C1140621
UMLS CUI [1,4]
C1527305
5a. How quickly do you get relief from walking?
Beschreibung

5a. How quickly do you get relief from walking?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0080331
UMLS CUI [1,2]
C0564405
UMLS CUI [1,3]
C1140621
UMLS CUI [1,4]
C1527305
UMLS CUI [1,5]
C0456962
5b. Will these feeling return if you continue to walk?
Beschreibung

if don’t know, go to #5d

Datentyp

integer

Alias
UMLS CUI [1,1]
C0080331
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1140621
UMLS CUI [1,4]
C1527305
UMLS CUI [1,5]
C0034897
5c. If you move your legs, do you get any relief from these feelings, even temporarily?
Beschreibung

if don’t know, go to #5d

Datentyp

integer

Alias
UMLS CUI [1,1]
C0561995
UMLS CUI [1,2]
C0564405
UMLS CUI [1,3]
C1140621
UMLS CUI [1,4]
C1527305
5d. What do you do to get relief from these feelings?
Beschreibung

5d. What do you do to get relief from these feelings?

Datentyp

text

Alias
UMLS CUI [1,1]
C0564405
UMLS CUI [1,2]
C1140621
UMLS CUI [1,3]
C1527305
6. Are these feelings in your legs more likely to occur while you are resting then when you are physically active?
Beschreibung

6. Are these feelings in your legs more likely to occur while you are resting then when you are physically active?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C2745955
UMLS CUI [1,4]
C0035253
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C2745955
UMLS CUI [2,4]
C0556453
7. Are these feelings in your legs a lot worse while you are sitting compared to when you are lying down?
Beschreibung

If yes, go to #7a. If no, go to #8.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0277814
UMLS CUI [1,4]
C1457868
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C0444334
UMLS CUI [2,4]
C1457868
7a. Would it be true to say that you have these feelings almost exclusively when you are sitting and only rarely, if ever, when lying down.
Beschreibung

7a. Would it be true to say that you have these feelings almost exclusively when you are sitting and only rarely, if ever, when lying down.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C1548966
UMLS CUI [1,4]
C0277814
UMLS CUI [2,1]
C1140621
UMLS CUI [2,2]
C1527305
UMLS CUI [2,3]
C0522498
UMLS CUI [2,4]
C0444334
8. Are these feelings in your legs worse at night or in the evening than other times of the day?
Beschreibung

If no, go to #8a.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3176727
UMLS CUI [1,2]
C1140621
UMLS CUI [1,3]
C1527305
UMLS CUI [2,1]
C1457868
UMLS CUI [2,2]
C0587117
UMLS CUI [2,3]
C1140621
UMLS CUI [2,4]
C1527305
9. Approximately, how old were you when you first noticed these feelings in your legs?
Beschreibung

9. Approximately, how old were you when you first noticed these feelings in your legs?

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C2745955
UMLS CUI [1,2]
C0205435
UMLS CUI [1,3]
C1140621
UMLS CUI [1,4]
C1527305
years
10. Do you still have these feelings in your legs?
Beschreibung

If yes, go to #11. If no, go to #10a.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0549178
10a.Did the feelings stop because you are currently on treatment?
Beschreibung

If yes, go to #11a. If no, go to #10b.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0087111
UMLS CUI [1,5]
C0678226
10b.How long ago did these feelings stop?
Beschreibung

10b.How long ago did these feelings stop?

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C2746065
UMLS CUI [1,4]
C0449238
years
10c.When you had these feelings in your legs, did they bother you for?
Beschreibung

Mark One

Datentyp

integer

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C4036195
UMLS CUI [1,4]
C0449238
10d.About how many (weeks, months or years) did these feelings bother you?
Beschreibung

11b.Please respond to the following questions (12-14) for the period of time during which you had these feelings.

Datentyp

integer

Maßeinheiten
  • weeks or months or years
Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C4036195
UMLS CUI [1,4]
C0449238
weeks or months or years
11. Are you presently on medication for these feelings?
Beschreibung

If yes please respond to the following questions (12) the way you think you would be if you were not on any treatment at this time. If no, go to #12.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0013227
12. How many days in the month do (did) you have these feelings?
Beschreibung

12. How many days in the month do (did) you have these feelings?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0556971
12. If < 1 per month, then how many times a year?
Beschreibung

12. If < 1 per month, then how many times a year?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0556970
12a.For how many years has it been occurring (did it occur) at least this frequently?
Beschreibung

Note: Is the # of life events greater than 20? If yes, go to #12c. If no, go to #12b.

Datentyp

integer

Maßeinheiten
  • years
Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0449238
UMLS CUI [1,4]
C0439234
years
12b.Did you ever have these feelings at least once a month for three consecutive months?
Beschreibung

12b.Did you ever have these feelings at least once a month for three consecutive months?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C3845349
UMLS CUI [1,4]
C1707491
12c.At what time of day do (did) these feelings usually start?
Beschreibung

12c.At what time of day do (did) these feelings usually start?

Datentyp

integer

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [1,3]
C0439548
UMLS CUI [1,4]
C1301880
13. Are you aware of any medications or medical problems which might be causing (have caused) these feelings or making (made) these feelings worse?
Beschreibung

13. Are you aware of any medications or medical problems which might be causing (have caused) these feelings or making (made) these feelings worse?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1140621
UMLS CUI [1,4]
C1527305
UMLS CUI [2,1]
C1254481
UMLS CUI [2,2]
C0085978
UMLS CUI [2,3]
C1140621
UMLS CUI [2,4]
C1527305
13a.(If yes) What is the medication or medical problem?
Beschreibung

13a.(If yes) What is the medication or medical problem?

Datentyp

text

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C1254481
14. At the time you first developed these feelings did you have any problems with anemia, iron deficiency, nerve damage in your legs or feet, or pregnancy?
Beschreibung

14. At the time you first developed these feelings did you have any problems with anemia, iron deficiency, nerve damage in your legs or feet, or pregnancy?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C1527305
UMLS CUI [2]
C0002871
UMLS CUI [3]
C0240066
UMLS CUI [4,1]
C0161479
UMLS CUI [4,2]
C1140621
UMLS CUI [4,3]
C0016504
UMLS CUI [5]
C0032961
14a.(If yes) Which problem(s)?
Beschreibung

14a.(If yes) Which problem(s)?

Datentyp

text

Alias
UMLS CUI [1]
C1254481
End of the Interview
Beschreibung

End of the Interview

Alias
UMLS CUI-1
C0021822
UMLS CUI-2
C0444930
15. Do you have any difficulty getting to sleep?
Beschreibung

if yes, go to #15a if no, go to #16

Datentyp

boolean

Alias
UMLS CUI [1]
C0393760
15a.How often?
Beschreibung

15a.How often?

Datentyp

integer

Alias
UMLS CUI [1,1]
C0393760
UMLS CUI [1,2]
C0439603
15b.Is this because your legs are bothering you and you must move them?
Beschreibung

if no, go to #16

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C4036195
UMLS CUI [2,1]
C0560560
UMLS CUI [2,2]
C1140621
15c.Can you tell me anything more about why your legs are bothering you and why you must move them? (Enter the comments on the line).
Beschreibung

Enter the comments on the line

Datentyp

text

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C4036195
UMLS CUI [1,3]
C0085978
UMLS CUI [2,1]
C0560560
UMLS CUI [2,2]
C1140621
UMLS CUI [2,3]
C0392360
16. If you wake up at night, do you have trouble getting back to sleep?
Beschreibung

If yes, go to #16a If no, interview is finished

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1170730
UMLS CUI [1,2]
C4086382
16a.How often?
Beschreibung

16a.How often?

Datentyp

integer

Alias
UMLS CUI [1]
C0439603
16b.Is this because your legs are bothering you and you must move them?
Beschreibung

If yes, go to #16c If no, interview is finished

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C4036195
UMLS CUI [2,1]
C0560560
UMLS CUI [2,2]
C1140621
16c.Can you tell me anything more about why your legs are bothering you and why you must move them?
Beschreibung

Enter the comments on the line

Datentyp

text

Alias
UMLS CUI [1,1]
C1140621
UMLS CUI [1,2]
C4036195
UMLS CUI [1,3]
C0085978
UMLS CUI [2,1]
C0560560
UMLS CUI [2,2]
C1140621
UMLS CUI [2,3]
C0392360
17. While you were pregnant, did you have unpleasant or uncomfortable feelings in your legs that occurred while you were either sitting or lying down?
Beschreibung

17. While you were pregnant, did you have unpleasant or uncomfortable feelings in your legs that occurred while you were either sitting or lying down?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1140621
UMLS CUI [1,3]
C1527305
UMLS CUI [1,4]
C0277814
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1140621
UMLS CUI [2,3]
C1527305
UMLS CUI [2,4]
C0444334
17a.While you were pregnant, did you have the need or urge to move your legs while you were either sitting or lying down?
Beschreibung

17a.While you were pregnant, did you have the need or urge to move your legs while you were either sitting or lying down?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1863322
UMLS CUI [1,3]
C0277814
UMLS CUI [2,1]
C0032961
UMLS CUI [2,2]
C1863322
UMLS CUI [2,3]
C0444334
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Ähnliche Modelle

Screening - RLS Diagnostic Clinical Interview

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Final Diagnosis
C1546485 (UMLS CUI-1)
Item
Final Diagnosis:
integer
C1546485 (UMLS CUI [1])
Final Diagnosis:
Code List
Final Diagnosis:
CL Item
Definite RLS  (1)
CL Item
Probable RLS (2)
CL Item
Possible RLS (3)
CL Item
Not-RLS (4)
CL Item
Secondary Definite (5)
CL Item
Secondary Possible (6)
CL Item
Diagnosis Unknown (7)
Cause for Final Diagnosis:
Item
Cause for Final Diagnosis:
text
C1546485 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Item Group
Please comlpete the follwing questions:
C1522634 (UMLS CUI-1)
C0205197 (UMLS CUI-2)
1. Have you ever had unpleasant or uncomfortable feelings in your legs that occurred mainly while you were either sitting or lying down?
Item
1. Have you ever had unpleasant or uncomfortable feelings in your legs that occurred mainly while you were either sitting or lying down?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C4062607 (UMLS CUI [1,3])
C0277814 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C4062607 (UMLS CUI [2,3])
C0444334 (UMLS CUI [2,4])
2. Are these feelings painful rather than just uncomfortable?
Item
2. Are these feelings painful rather than just uncomfortable?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
2a. How would you describe these feelings or sensations?
Item
2a. How would you describe these feelings or sensations?
text
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
3. Have you ever felt the need or urge to move your legs that occurred mainly while you were either sitting or lying down?
Item
3. Have you ever felt the need or urge to move your legs that occurred mainly while you were either sitting or lying down?
boolean
C1863322 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
C1863322 (UMLS CUI [2,1])
C0444334 (UMLS CUI [2,2])
3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
Item
3a. Do these feelings in your legs ever become overwhelming to the point that you cannot resist moving your legs?
boolean
C1863322 (UMLS CUI [1])
Item
3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
integer
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0558185 (UMLS CUI [1,3])
C1280500 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C1948035 (UMLS CUI [2,3])
C1280500 (UMLS CUI [2,4])
3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
Code List
3b. If you developed these feelings in your legs and you could not move your legs, or if someone were to hold your legs down, how would this effect the feelings in your legs?:
CL Item
A lot Better  (1)
CL Item
Some Better  (2)
CL Item
No Difference  (3)
CL Item
Some Worse  (4)
CL Item
A lot Worse (5)
4. Do you think these feelings in your legs are due to a Charlie-horse or muscle cramp?
Item
4. Do you think these feelings in your legs are due to a Charlie-horse or muscle cramp?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0277823 (UMLS CUI [1,3])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0026821 (UMLS CUI [2,3])
4a. Are these feelings always due to a Charlie-horse or muscle cramp?
Item
4a. Are these feelings always due to a Charlie-horse or muscle cramp?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0277823 (UMLS CUI [1,3])
C2003902 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0026821 (UMLS CUI [2,3])
C2003902 (UMLS CUI [2,4])
Item
5. While you are actually walking around, do you get any relief from these feelings?
integer
C0080331 (UMLS CUI [1,1])
C0564405 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
5. While you are actually walking around, do you get any relief from these feelings?
Code List
5. While you are actually walking around, do you get any relief from these feelings?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Don't Know (3)
Item
5a. How quickly do you get relief from walking?
integer
C0080331 (UMLS CUI [1,1])
C0564405 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
C0456962 (UMLS CUI [1,5])
5a. How quickly do you get relief from walking?
Code List
5a. How quickly do you get relief from walking?
CL Item
Almost immediately  (1)
CL Item
Soon after walking  (2)
CL Item
Only after awhile (3)
Item
5b. Will these feeling return if you continue to walk?
integer
C0080331 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
C0034897 (UMLS CUI [1,5])
5b. Will these feeling return if you continue to walk?
Code List
5b. Will these feeling return if you continue to walk?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Don't Know (3)
Item
5c. If you move your legs, do you get any relief from these feelings, even temporarily?
integer
C0561995 (UMLS CUI [1,1])
C0564405 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
5c. If you move your legs, do you get any relief from these feelings, even temporarily?
Code List
5c. If you move your legs, do you get any relief from these feelings, even temporarily?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Don't Know (3)
5d. What do you do to get relief from these feelings?
Item
5d. What do you do to get relief from these feelings?
text
C0564405 (UMLS CUI [1,1])
C1140621 (UMLS CUI [1,2])
C1527305 (UMLS CUI [1,3])
6. Are these feelings in your legs more likely to occur while you are resting then when you are physically active?
Item
6. Are these feelings in your legs more likely to occur while you are resting then when you are physically active?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0035253 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0556453 (UMLS CUI [2,4])
7. Are these feelings in your legs a lot worse while you are sitting compared to when you are lying down?
Item
7. Are these feelings in your legs a lot worse while you are sitting compared to when you are lying down?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,3])
C1457868 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0444334 (UMLS CUI [2,3])
C1457868 (UMLS CUI [2,4])
7a. Would it be true to say that you have these feelings almost exclusively when you are sitting and only rarely, if ever, when lying down.
Item
7a. Would it be true to say that you have these feelings almost exclusively when you are sitting and only rarely, if ever, when lying down.
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C1548966 (UMLS CUI [1,3])
C0277814 (UMLS CUI [1,4])
C1140621 (UMLS CUI [2,1])
C1527305 (UMLS CUI [2,2])
C0522498 (UMLS CUI [2,3])
C0444334 (UMLS CUI [2,4])
8. Are these feelings in your legs worse at night or in the evening than other times of the day?
Item
8. Are these feelings in your legs worse at night or in the evening than other times of the day?
boolean
C3176727 (UMLS CUI [1,1])
C1140621 (UMLS CUI [1,2])
C1527305 (UMLS CUI [1,3])
C1457868 (UMLS CUI [2,1])
C0587117 (UMLS CUI [2,2])
C1140621 (UMLS CUI [2,3])
C1527305 (UMLS CUI [2,4])
9. Approximately, how old were you when you first noticed these feelings in your legs?
Item
9. Approximately, how old were you when you first noticed these feelings in your legs?
integer
C2745955 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
10. Do you still have these feelings in your legs?
Item
10. Do you still have these feelings in your legs?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
10a.Did the feelings stop because you are currently on treatment?
Item
10a.Did the feelings stop because you are currently on treatment?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
C0678226 (UMLS CUI [1,5])
10b.How long ago did these feelings stop?
Item
10b.How long ago did these feelings stop?
integer
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C2746065 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Item
10c.When you had these feelings in your legs, did they bother you for?
integer
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C4036195 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
10c.When you had these feelings in your legs, did they bother you for?
Code List
10c.When you had these feelings in your legs, did they bother you for?
CL Item
Weeks (1)
CL Item
Months (2)
CL Item
Years (3)
10d.About how many (weeks, months or years) did these feelings bother you?
Item
10d.About how many (weeks, months or years) did these feelings bother you?
integer
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C4036195 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
11. Are you presently on medication for these feelings?
Item
11. Are you presently on medication for these feelings?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Item
12. How many days in the month do (did) you have these feelings?
integer
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0556971 (UMLS CUI [1,3])
12. How many days in the month do (did) you have these feelings?
Code List
12. How many days in the month do (did) you have these feelings?
CL Item
<1 per month  (1)
CL Item
1 per month  (2)
CL Item
2-4 X per month (3)
CL Item
5-15 X per month  (4)
CL Item
16-25 X per month  (5)
CL Item
daily (6)
12. If < 1 per month, then how many times a year?
Item
12. If < 1 per month, then how many times a year?
integer
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0556970 (UMLS CUI [1,3])
12a.For how many years has it been occurring (did it occur) at least this frequently?
Item
12a.For how many years has it been occurring (did it occur) at least this frequently?
integer
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
C0439234 (UMLS CUI [1,4])
12b.Did you ever have these feelings at least once a month for three consecutive months?
Item
12b.Did you ever have these feelings at least once a month for three consecutive months?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C3845349 (UMLS CUI [1,3])
C1707491 (UMLS CUI [1,4])
Item
12c.At what time of day do (did) these feelings usually start?
integer
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0439548 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,4])
12c.At what time of day do (did) these feelings usually start?
Code List
12c.At what time of day do (did) these feelings usually start?
CL Item
during sleep  (1)
CL Item
at bedtime  (2)
CL Item
after 6 p.m., but before bedtime (3)
CL Item
before 6 p.m.  (4)
CL Item
before noon (5)
13. Are you aware of any medications or medical problems which might be causing (have caused) these feelings or making (made) these feelings worse?
Item
13. Are you aware of any medications or medical problems which might be causing (have caused) these feelings or making (made) these feelings worse?
boolean
C0013227 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1140621 (UMLS CUI [1,3])
C1527305 (UMLS CUI [1,4])
C1254481 (UMLS CUI [2,1])
C0085978 (UMLS CUI [2,2])
C1140621 (UMLS CUI [2,3])
C1527305 (UMLS CUI [2,4])
13a.(If yes) What is the medication or medical problem?
Item
13a.(If yes) What is the medication or medical problem?
text
C0013227 (UMLS CUI [1])
C1254481 (UMLS CUI [2])
14. At the time you first developed these feelings did you have any problems with anemia, iron deficiency, nerve damage in your legs or feet, or pregnancy?
Item
14. At the time you first developed these feelings did you have any problems with anemia, iron deficiency, nerve damage in your legs or feet, or pregnancy?
boolean
C1140621 (UMLS CUI [1,1])
C1527305 (UMLS CUI [1,2])
C0002871 (UMLS CUI [2])
C0240066 (UMLS CUI [3])
C0161479 (UMLS CUI [4,1])
C1140621 (UMLS CUI [4,2])
C0016504 (UMLS CUI [4,3])
C0032961 (UMLS CUI [5])
14a.(If yes) Which problem(s)?
Item
14a.(If yes) Which problem(s)?
text
C1254481 (UMLS CUI [1])
Item Group
End of the Interview
C0021822 (UMLS CUI-1)
C0444930 (UMLS CUI-2)
15. Do you have any difficulty getting to sleep?
Item
15. Do you have any difficulty getting to sleep?
boolean
C0393760 (UMLS CUI [1])
Item
15a.How often?
integer
C0393760 (UMLS CUI [1,1])
C0439603 (UMLS CUI [1,2])
15a.How often?
Code List
15a.How often?
CL Item
sometimes (1)
CL Item
not often  (2)
CL Item
only rarely  (3)
CL Item
not usually (4)
15b.Is this because your legs are bothering you and you must move them?
Item
15b.Is this because your legs are bothering you and you must move them?
boolean
C1140621 (UMLS CUI [1,1])
C4036195 (UMLS CUI [1,2])
C0560560 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
15c. Why are th elegs bothering and why do you have to move them?
Item
15c.Can you tell me anything more about why your legs are bothering you and why you must move them? (Enter the comments on the line).
text
C1140621 (UMLS CUI [1,1])
C4036195 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0560560 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
16. If you wake up at night, do you have trouble getting back to sleep?
Item
16. If you wake up at night, do you have trouble getting back to sleep?
boolean
C1170730 (UMLS CUI [1,1])
C4086382 (UMLS CUI [1,2])
Item
16a.How often?
integer
C0439603 (UMLS CUI [1])
16a.How often?
Code List
16a.How often?
CL Item
sometimes (1)
CL Item
not often  (2)
CL Item
only rarely  (3)
CL Item
not usually (4)
16b.Is this because your legs are bothering you and you must move them?
Item
16b.Is this because your legs are bothering you and you must move them?
boolean
C1140621 (UMLS CUI [1,1])
C4036195 (UMLS CUI [1,2])
C0560560 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
16c.Why are th elegs bothering and why do you have to move them?
Item
16c.Can you tell me anything more about why your legs are bothering you and why you must move them?
text
C1140621 (UMLS CUI [1,1])
C4036195 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C0560560 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C0392360 (UMLS CUI [2,3])
17. While you were pregnant, did you have unpleasant or uncomfortable feelings in your legs that occurred while you were either sitting or lying down?
Item
17. While you were pregnant, did you have unpleasant or uncomfortable feelings in your legs that occurred while you were either sitting or lying down?
boolean
C0032961 (UMLS CUI [1,1])
C1140621 (UMLS CUI [1,2])
C1527305 (UMLS CUI [1,3])
C0277814 (UMLS CUI [1,4])
C0032961 (UMLS CUI [2,1])
C1140621 (UMLS CUI [2,2])
C1527305 (UMLS CUI [2,3])
C0444334 (UMLS CUI [2,4])
17a.While you were pregnant, did you have the need or urge to move your legs while you were either sitting or lying down?
Item
17a.While you were pregnant, did you have the need or urge to move your legs while you were either sitting or lying down?
boolean
C0032961 (UMLS CUI [1,1])
C1863322 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2,1])
C1863322 (UMLS CUI [2,2])
C0444334 (UMLS CUI [2,3])
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