ID

14229

Beschreibung

Vitamin D in Pediatric Asthma: a Randomized Controlled Open-label Pilot Trial; ODM derived from: https://clinicaltrials.gov/show/NCT02054975

Link

https://clinicaltrials.gov/show/NCT02054975

Stichworte

Versionen (1)
  1. 05.04.16 05.04.16 -
Hochgeladen am

5. April 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Asthma NCT02054975

Englisch

Eligibility Asthma NCT02054975

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02054975
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. informed consent and assent signed and dated before participation.
Beschreibung

Informed Consent | Assent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1879749
2. male or female, ages 8 through 17 at baseline; all races and ethnicities
Beschreibung

Age | Gender | Racial group | Ethnic group

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0034510
UMLS CUI [4]
C0015031
3. asthma and currently taking a prescribed daily inhaled steroid asthma medication
Beschreibung

Asthma | inhaled steroids

Datentyp

boolean

Alias
UMLS CUI [1]
C0004096
UMLS CUI [2]
C2065041
4. english-speaking with at least one english-speaking parent
Beschreibung

Able to speak | English Language | parent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2]
C0030551
5. vitamin d deficiency (<20 ng/ml)
Beschreibung

Vitamin D Deficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0042870
6. compliant with attending at least 2/4 of their last asthma-related scheduled clinic visits
Beschreibung

Compliance behavior | Clinic Visits | Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2,1]
C0008952
UMLS CUI [2,2]
C0004096
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. if female, pregnant, planning to become pregnant, and/or sexually active and not using reliable contraception
Beschreibung

Pregnancy | Pregnancy, Planned | Sexually active | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0241028
UMLS CUI [4]
C0700589
2. unable to provide informed consent (mental retardation, etc)
Beschreibung

Informed Consent | Limited | Mental Retardation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [2]
C0025362
3. current substance dependence (within the past 2 months)
Beschreibung

Substance Dependence

Datentyp

boolean

Alias
UMLS CUI [1]
C0038580
4. known metabolic bone disease, including rickets
Beschreibung

Metabolic Bone Disorder | Rickets

Datentyp

boolean

Alias
UMLS CUI [1]
C0005944
UMLS CUI [2]
C0035579
5. known malabsorption disease: crohn's, ulcerative colitis, celiac sprue
Beschreibung

Malabsorption Syndrome | Crohn Disease | Ulcerative Colitis | Celiac Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
UMLS CUI [4]
C0007570
6. bmi>40
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
7. has begun new treatment with vitamin d (>600 iu/day) within the past month
Beschreibung

Therapeutic procedure | Vitamin D

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0042866
8. treatment with prednisone or other oral or iv steroid within the past 4 weeks
Beschreibung

Therapeutic procedure | Prednisone | Adrenal Cortex Hormones | Intravenous steroid injection

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0032952
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0563322
9. taking mineral oil or thiazide diuretics on a daily basis
Beschreibung

Taking medication | Mineral Oil | Thiazide Diuretics

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1290952
UMLS CUI [1,2]
C0026156
UMLS CUI [2]
C0012802
10. acute or chronic liver, renal, endocrine, neurologic, infectious, autoimmune, cardiac, pulmonary, gastrointestinal, hematologic, metabolic disorder or any other disorder, per study physician judgment.
Beschreibung

Liver diseases | Kidney Diseases | Endocrine System Diseases | nervous system disorder | Communicable Diseases | Autoimmune Diseases | Heart Diseases | Lung diseases | Gastrointestinal Diseases | Hematological Disease | Metabolic Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0014130
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0009450
UMLS CUI [6]
C0004364
UMLS CUI [7]
C0018799
UMLS CUI [8]
C0024115
UMLS CUI [9]
C0017178
UMLS CUI [10]
C0018939
UMLS CUI [11]
C0025517
11. severe treatment noncompliance documented in medical record or by managing provider report.
Beschreibung

Noncompliance with therapeutic regimen | Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0184543
UMLS CUI [1,2]
C0205082
our definition of a highly effective method of birth control is consistent with ich guidance for industry m3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals (april 1997) when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine devices (iuds), sexual abstinence, or a vasectomized partner. subjects will also be reminded to use condoms to prevent sexually transmitted diseases and as a second method toward birth control.
Beschreibung

Contraceptive methods | Contraceptive implant | Contraceptive injection | Contraceptives, Oral | Intrauterine Devices | Sexual Abstinence | Vasectomy | condom use

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2]
C1657106
UMLS CUI [3]
C1656586
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0036899
UMLS CUI [7]
C0042387
UMLS CUI [8]
C0679782
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Ähnliche Modelle

Eligibility Asthma NCT02054975

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT02054975
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Assent
Item
1. informed consent and assent signed and dated before participation.
boolean
C0021430 (UMLS CUI [1,1])
C1879749 (UMLS CUI [1,2])
Age | Gender | Racial group | Ethnic group
Item
2. male or female, ages 8 through 17 at baseline; all races and ethnicities
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0034510 (UMLS CUI [3])
C0015031 (UMLS CUI [4])
Asthma | inhaled steroids
Item
3. asthma and currently taking a prescribed daily inhaled steroid asthma medication
boolean
C0004096 (UMLS CUI [1])
C2065041 (UMLS CUI [2])
Able to speak | English Language | parent
Item
4. english-speaking with at least one english-speaking parent
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0030551 (UMLS CUI [2])
Vitamin D Deficiency
Item
5. vitamin d deficiency (<20 ng/ml)
boolean
C0042870 (UMLS CUI [1])
Compliance behavior | Clinic Visits | Asthma
Item
6. compliant with attending at least 2/4 of their last asthma-related scheduled clinic visits
boolean
C1321605 (UMLS CUI [1])
C0008952 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned | Sexually active | Contraceptive methods
Item
1. if female, pregnant, planning to become pregnant, and/or sexually active and not using reliable contraception
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0241028 (UMLS CUI [3])
C0700589 (UMLS CUI [4])
Informed Consent | Limited | Mental Retardation
Item
2. unable to provide informed consent (mental retardation, etc)
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0025362 (UMLS CUI [2])
Substance Dependence
Item
3. current substance dependence (within the past 2 months)
boolean
C0038580 (UMLS CUI [1])
Metabolic Bone Disorder | Rickets
Item
4. known metabolic bone disease, including rickets
boolean
C0005944 (UMLS CUI [1])
C0035579 (UMLS CUI [2])
Malabsorption Syndrome | Crohn Disease | Ulcerative Colitis | Celiac Disease
Item
5. known malabsorption disease: crohn's, ulcerative colitis, celiac sprue
boolean
C0024523 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0007570 (UMLS CUI [4])
Body mass index
Item
6. bmi>40
boolean
C1305855 (UMLS CUI [1])
Therapeutic procedure | Vitamin D
Item
7. has begun new treatment with vitamin d (>600 iu/day) within the past month
boolean
C0087111 (UMLS CUI [1,1])
C0042866 (UMLS CUI [1,2])
Therapeutic procedure | Prednisone | Adrenal Cortex Hormones | Intravenous steroid injection
Item
8. treatment with prednisone or other oral or iv steroid within the past 4 weeks
boolean
C0087111 (UMLS CUI [1,1])
C0032952 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2])
C0563322 (UMLS CUI [3])
Taking medication | Mineral Oil | Thiazide Diuretics
Item
9. taking mineral oil or thiazide diuretics on a daily basis
boolean
C1290952 (UMLS CUI [1,1])
C0026156 (UMLS CUI [1,2])
C0012802 (UMLS CUI [2])
Liver diseases | Kidney Diseases | Endocrine System Diseases | nervous system disorder | Communicable Diseases | Autoimmune Diseases | Heart Diseases | Lung diseases | Gastrointestinal Diseases | Hematological Disease | Metabolic Diseases
Item
10. acute or chronic liver, renal, endocrine, neurologic, infectious, autoimmune, cardiac, pulmonary, gastrointestinal, hematologic, metabolic disorder or any other disorder, per study physician judgment.
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0014130 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0009450 (UMLS CUI [5])
C0004364 (UMLS CUI [6])
C0018799 (UMLS CUI [7])
C0024115 (UMLS CUI [8])
C0017178 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
C0025517 (UMLS CUI [11])
Noncompliance with therapeutic regimen | Severe
Item
11. severe treatment noncompliance documented in medical record or by managing provider report.
boolean
C0184543 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Contraceptive methods | Contraceptive implant | Contraceptive injection | Contraceptives, Oral | Intrauterine Devices | Sexual Abstinence | Vasectomy | condom use
Item
our definition of a highly effective method of birth control is consistent with ich guidance for industry m3 nonclinical safety studies for the conduct of human clinical trials for pharmaceuticals (april 1997) when used consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine devices (iuds), sexual abstinence, or a vasectomized partner. subjects will also be reminded to use condoms to prevent sexually transmitted diseases and as a second method toward birth control.
boolean
C0700589 (UMLS CUI [1])
C1657106 (UMLS CUI [2])
C1656586 (UMLS CUI [3])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
C0042387 (UMLS CUI [7])
C0679782 (UMLS CUI [8])
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