ID

35279

Descrição

The Effect of a Renal Specific Oral Nutritional Supplement on Nutritional Status; ODM derived from: https://clinicaltrials.gov/show/NCT02046746

Link

https://clinicaltrials.gov/show/NCT02046746

Palavras-chave

Versões (1)
  1. 26/02/2019 26/02/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de fevereiro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Chronic Kidney Disease NCT02046746

Inglês

Eligibility Chronic Kidney Disease NCT02046746

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. >18 years of age
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
2. diagnosed with chronic kidney disease (ckd); stages 3b to 5
Descrição

Chronic kidney disease stage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2074731
3. egfr ≤ 45 and ≥ 10 ml/min/1.73m2
Descrição

Estimated Glomerular Filtration Rate

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3811844
4. male or non-pregnant female at least six weeks postpartum and non-lactating
Descrição

Gender | Gender Pregnancy Absent | Postpartum Period | Gender Breast Feeding Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0032961
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0086839
UMLS CUI [4,1]
C0079399
UMLS CUI [4,2]
C0006147
UMLS CUI [4,3]
C0332197
5. subject with ckd is either: not diagnosed with type 2 diabetes mellitus (t2dm) or diagnosed with t2dm and had no changes in glycemic medication (dose or type) for at least 2 months
Descrição

Chronic Kidney Disease | Non-Insulin-Dependent Diabetes Mellitus Absent | Diabetes Mellitus, Non-Insulin-Dependent | Glycemic Agents Dose unchanged | Glycemic Agents Type unchanged

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0011860
UMLS CUI [4,1]
C4020583
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0442739
UMLS CUI [5,1]
C4020583
UMLS CUI [5,2]
C0332307
UMLS CUI [5,3]
C0442739
6. serum albumin ≥ 3.0g/dl
Descrição

Serum albumin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0523465
7. bmi ≤ 27 kg/m2
Descrição

Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1305855
8. if t2dm, subject has a1c level ≤ 9.0%
Descrição

Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0474680
9. not scheduled or expected to receive dialysis in the next 18 months
Descrição

Absence Dialysis Scheduled | Absence Dialysis Expected

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0011946
UMLS CUI [1,3]
C0205539
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0011946
UMLS CUI [2,3]
C1517001
10. life expectancy >18 months
Descrição

Life Expectancy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. type 1 diabetes
Descrição

Diabetes Mellitus, Insulin-Dependent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
2. subjective global assessment = 1 to 3
Descrição

Subjective global assessment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0451514
3. intravenous albumin treatment within the last 6 months.
Descrição

Albumin Intravenous

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0001924
UMLS CUI [1,2]
C1522726
4. overt symptomatic peripheral neuropathy, retinopathy, or autonomic neuropathy.
Descrição

Peripheral Neuropathy Symptomatic | Retinal Disease Symptomatic | Autonomic neuropathy Symptomatic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0035309
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0259749
UMLS CUI [3,2]
C0231220
5. poorly controlled chronic hypertension >200/100 or hypotension <90/60 defined by the joint national committee 7 (jnc 7).
Descrição

Hypertension chronic Poorly controlled | Chronic hypotension Poorly controlled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0745114
UMLS CUI [1,2]
C3853134
UMLS CUI [2,1]
C0155800
UMLS CUI [2,2]
C3853134
6. major surgery, inpatient or outpatient, requiring >7 days of hospitalization in the last 3 weeks prior to screening visit, or is having major elective surgery requiring >7 days of hospitalization throughout the course of the entire study.
Descrição

Major surgery Inpatient | Major surgery Outpatients | Hospitalization length of stay (___ days) | Major surgery elective

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C0021562
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C0029921
UMLS CUI [3]
C3694481
UMLS CUI [4,1]
C0679637
UMLS CUI [4,2]
C0439608
7. chronic/contagious infectious disease, clotting or bleeding disorder, active malignancy or impaired liver function
Descrição

Chronic infectious disease | Blood Coagulation Disorders | Malignant Neoplasms | Liver Dysfunction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0086565
8. missing, or has had an amputation of, a limb.
Descrição

Missing limb | Amputation of limb

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1719258
UMLS CUI [2]
C0002689
9. significant cardiovascular event ≤ 6 months; or stated history of congestive heart failure
Descrição

Cardiovascular event | Congestive heart failure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1320716
UMLS CUI [2]
C0018802
10. obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease such as gastroparesis, pancreatitis, hepatitis, jaundice, celiac disease, intestinal dysmotility and ischemic colitis.
Descrição

Gastrointestinal obstruction | Inflammatory Bowel Disease | Short Bowel Syndrome | Gastrointestinal Disease | Gastroparesis | Pancreatitis | Hepatitis | Icterus | Celiac Disease | Intestinal dysmotility | Colitis, Ischemic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0236124
UMLS CUI [2]
C0021390
UMLS CUI [3]
C0036992
UMLS CUI [4]
C0017178
UMLS CUI [5]
C0152020
UMLS CUI [6]
C0030305
UMLS CUI [7]
C0019158
UMLS CUI [8]
C0022346
UMLS CUI [9]
C0007570
UMLS CUI [10]
C3552513
UMLS CUI [11]
C0162529
11. current diagnosis or history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse
Descrição

Severe dementia | Delirium Severe | Eating Disorders | Nervous system disorder | Mental disorders | Alcoholic Intoxication, Chronic | Substance Use Disorders

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3494652
UMLS CUI [2,1]
C0011206
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C0013473
UMLS CUI [4]
C0027765
UMLS CUI [5]
C0004936
UMLS CUI [6]
C0001973
UMLS CUI [7]
C0038586
12. medications/dietary supplements/herbals or substances that could modulate glucose metabolism, or are considered anabolic, or can reduce fat mass, including but not limited to protein/amino acid supplements, or modified amino acid supplements such as keto acids, growth hormone, dronabinol, marijuana, calcium beta-hydroxyl-beta-methylbutyrate, high dose fish oil supplements (>0.5 g omega-3/d) or vitamin d (>400iu/d),
Descrição

Pharmaceutical Preparations Modulating Glucose metabolism | Dietary Supplements Modulating Glucose metabolism | Plant Preparations Modulating Glucose metabolism | Substance Modulating Glucose metabolism | Anabolic Agents | Reducing diet | Protein supplement | Amino acid supplement | Amino acid supplement modified | Keto Acids | Growth Hormone | Tetrahydrocannabinol | Marihuana | Calcium beta-hydroxy-beta-methylbutyrate | Fish Oil Supplements High dose | Omega-3 Fatty Acids | Vitamin D

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0443264
UMLS CUI [1,3]
C0596620
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0443264
UMLS CUI [2,3]
C0596620
UMLS CUI [3,1]
C0949854
UMLS CUI [3,2]
C0443264
UMLS CUI [3,3]
C0596620
UMLS CUI [4,1]
C0439861
UMLS CUI [4,2]
C0443264
UMLS CUI [4,3]
C0596620
UMLS CUI [5]
C1258800
UMLS CUI [6]
C0012167
UMLS CUI [7]
C0770246
UMLS CUI [8]
C0556082
UMLS CUI [9,1]
C0556082
UMLS CUI [9,2]
C0392747
UMLS CUI [10]
C0022618
UMLS CUI [11]
C0037663
UMLS CUI [12]
C0039663
UMLS CUI [13]
C0024808
UMLS CUI [14]
C2741019
UMLS CUI [15,1]
C0016157
UMLS CUI [15,2]
C0242295
UMLS CUI [15,3]
C0444956
UMLS CUI [16]
C0015689
UMLS CUI [17]
C0042866
13. allergic or intolerant to any ingredient found in the study product.
Descrição

Allergic Reaction Investigational New Drug Ingredient | Intolerance to Investigational New Drug Ingredient

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C1550600
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1550600
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Eligibility Chronic Kidney Disease NCT02046746

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. >18 years of age
boolean
C0001779 (UMLS CUI [1])
Chronic kidney disease stage
Item
2. diagnosed with chronic kidney disease (ckd); stages 3b to 5
boolean
C2074731 (UMLS CUI [1])
Estimated Glomerular Filtration Rate
Item
3. egfr ≤ 45 and ≥ 10 ml/min/1.73m2
boolean
C3811844 (UMLS CUI [1])
Gender | Gender Pregnancy Absent | Postpartum Period | Gender Breast Feeding Absent
Item
4. male or non-pregnant female at least six weeks postpartum and non-lactating
boolean
C0079399 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0032961 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0086839 (UMLS CUI [3])
C0079399 (UMLS CUI [4,1])
C0006147 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Chronic Kidney Disease | Non-Insulin-Dependent Diabetes Mellitus Absent | Diabetes Mellitus, Non-Insulin-Dependent | Glycemic Agents Dose unchanged | Glycemic Agents Type unchanged
Item
5. subject with ckd is either: not diagnosed with type 2 diabetes mellitus (t2dm) or diagnosed with t2dm and had no changes in glycemic medication (dose or type) for at least 2 months
boolean
C1561643 (UMLS CUI [1])
C0011860 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0011860 (UMLS CUI [3])
C4020583 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0442739 (UMLS CUI [4,3])
C4020583 (UMLS CUI [5,1])
C0332307 (UMLS CUI [5,2])
C0442739 (UMLS CUI [5,3])
Serum albumin measurement
Item
6. serum albumin ≥ 3.0g/dl
boolean
C0523465 (UMLS CUI [1])
Body mass index
Item
7. bmi ≤ 27 kg/m2
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement
Item
8. if t2dm, subject has a1c level ≤ 9.0%
boolean
C0011860 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Absence Dialysis Scheduled | Absence Dialysis Expected
Item
9. not scheduled or expected to receive dialysis in the next 18 months
boolean
C0332197 (UMLS CUI [1,1])
C0011946 (UMLS CUI [1,2])
C0205539 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0011946 (UMLS CUI [2,2])
C1517001 (UMLS CUI [2,3])
Life Expectancy
Item
10. life expectancy >18 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
1. type 1 diabetes
boolean
C0011854 (UMLS CUI [1])
Subjective global assessment
Item
2. subjective global assessment = 1 to 3
boolean
C0451514 (UMLS CUI [1])
Albumin Intravenous
Item
3. intravenous albumin treatment within the last 6 months.
boolean
C0001924 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Peripheral Neuropathy Symptomatic | Retinal Disease Symptomatic | Autonomic neuropathy Symptomatic
Item
4. overt symptomatic peripheral neuropathy, retinopathy, or autonomic neuropathy.
boolean
C0031117 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0259749 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
Hypertension chronic Poorly controlled | Chronic hypotension Poorly controlled
Item
5. poorly controlled chronic hypertension >200/100 or hypotension <90/60 defined by the joint national committee 7 (jnc 7).
boolean
C0745114 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0155800 (UMLS CUI [2,1])
C3853134 (UMLS CUI [2,2])
Major surgery Inpatient | Major surgery Outpatients | Hospitalization length of stay (___ days) | Major surgery elective
Item
6. major surgery, inpatient or outpatient, requiring >7 days of hospitalization in the last 3 weeks prior to screening visit, or is having major elective surgery requiring >7 days of hospitalization throughout the course of the entire study.
boolean
C0679637 (UMLS CUI [1,1])
C0021562 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2,1])
C0029921 (UMLS CUI [2,2])
C3694481 (UMLS CUI [3])
C0679637 (UMLS CUI [4,1])
C0439608 (UMLS CUI [4,2])
Chronic infectious disease | Blood Coagulation Disorders | Malignant Neoplasms | Liver Dysfunction
Item
7. chronic/contagious infectious disease, clotting or bleeding disorder, active malignancy or impaired liver function
boolean
C0151317 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0086565 (UMLS CUI [4])
Missing limb | Amputation of limb
Item
8. missing, or has had an amputation of, a limb.
boolean
C1719258 (UMLS CUI [1])
C0002689 (UMLS CUI [2])
Cardiovascular event | Congestive heart failure
Item
9. significant cardiovascular event ≤ 6 months; or stated history of congestive heart failure
boolean
C1320716 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
Gastrointestinal obstruction | Inflammatory Bowel Disease | Short Bowel Syndrome | Gastrointestinal Disease | Gastroparesis | Pancreatitis | Hepatitis | Icterus | Celiac Disease | Intestinal dysmotility | Colitis, Ischemic
Item
10. obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease such as gastroparesis, pancreatitis, hepatitis, jaundice, celiac disease, intestinal dysmotility and ischemic colitis.
boolean
C0236124 (UMLS CUI [1])
C0021390 (UMLS CUI [2])
C0036992 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0152020 (UMLS CUI [5])
C0030305 (UMLS CUI [6])
C0019158 (UMLS CUI [7])
C0022346 (UMLS CUI [8])
C0007570 (UMLS CUI [9])
C3552513 (UMLS CUI [10])
C0162529 (UMLS CUI [11])
Severe dementia | Delirium Severe | Eating Disorders | Nervous system disorder | Mental disorders | Alcoholic Intoxication, Chronic | Substance Use Disorders
Item
11. current diagnosis or history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse
boolean
C3494652 (UMLS CUI [1])
C0011206 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0013473 (UMLS CUI [3])
C0027765 (UMLS CUI [4])
C0004936 (UMLS CUI [5])
C0001973 (UMLS CUI [6])
C0038586 (UMLS CUI [7])
Pharmaceutical Preparations Modulating Glucose metabolism | Dietary Supplements Modulating Glucose metabolism | Plant Preparations Modulating Glucose metabolism | Substance Modulating Glucose metabolism | Anabolic Agents | Reducing diet | Protein supplement | Amino acid supplement | Amino acid supplement modified | Keto Acids | Growth Hormone | Tetrahydrocannabinol | Marihuana | Calcium beta-hydroxy-beta-methylbutyrate | Fish Oil Supplements High dose | Omega-3 Fatty Acids | Vitamin D
Item
12. medications/dietary supplements/herbals or substances that could modulate glucose metabolism, or are considered anabolic, or can reduce fat mass, including but not limited to protein/amino acid supplements, or modified amino acid supplements such as keto acids, growth hormone, dronabinol, marijuana, calcium beta-hydroxyl-beta-methylbutyrate, high dose fish oil supplements (>0.5 g omega-3/d) or vitamin d (>400iu/d),
boolean
C0013227 (UMLS CUI [1,1])
C0443264 (UMLS CUI [1,2])
C0596620 (UMLS CUI [1,3])
C0242295 (UMLS CUI [2,1])
C0443264 (UMLS CUI [2,2])
C0596620 (UMLS CUI [2,3])
C0949854 (UMLS CUI [3,1])
C0443264 (UMLS CUI [3,2])
C0596620 (UMLS CUI [3,3])
C0439861 (UMLS CUI [4,1])
C0443264 (UMLS CUI [4,2])
C0596620 (UMLS CUI [4,3])
C1258800 (UMLS CUI [5])
C0012167 (UMLS CUI [6])
C0770246 (UMLS CUI [7])
C0556082 (UMLS CUI [8])
C0556082 (UMLS CUI [9,1])
C0392747 (UMLS CUI [9,2])
C0022618 (UMLS CUI [10])
C0037663 (UMLS CUI [11])
C0039663 (UMLS CUI [12])
C0024808 (UMLS CUI [13])
C2741019 (UMLS CUI [14])
C0016157 (UMLS CUI [15,1])
C0242295 (UMLS CUI [15,2])
C0444956 (UMLS CUI [15,3])
C0015689 (UMLS CUI [16])
C0042866 (UMLS CUI [17])
Allergic Reaction Investigational New Drug Ingredient | Intolerance to Investigational New Drug Ingredient
Item
13. allergic or intolerant to any ingredient found in the study product.
boolean
C1527304 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C1550600 (UMLS CUI [1,3])
C1744706 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1550600 (UMLS CUI [2,3])
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