Eligibility Fasting Mimicking Diet NCT02126449

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StudyEvent: Eligibility
1. Eligibility Fasting Mimicking Diet NCT02126449

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Gender | Breast Carcinoma TNM Breast tumor staging | AC-T Regimen Neoadjuvant

Item

female patients with stage ii or iii (ct1cn+ or ≥t2 any cn, cm0) breast cancer receiving neoadjuvant ac-t

boolean

C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C1879500 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])

Measurable Disease | Breast | Lymph nodes

Item

measurable disease (breast and/or lymph nodes)

boolean

C1513041 (UMLS CUI [1])
C0006141 (UMLS CUI [2])
C0024204 (UMLS CUI [3])

HER2 Negative Core needle biopsy | Age

Item

her2 negative core biopsy age ≥18 years

boolean

C2348908 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])

WHO performance status scale

Item

who performance status 0-2

boolean

C1298650 (UMLS CUI [1])

Bone Marrow function | White Blood Cell Count procedure | Neutrophil count

Item

adequate bone marrow function : white blood cells (wbcs) ≥3.0 x 109/l, neutrophils

boolean

C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0200633 (UMLS CUI [3])

Platelet Count measurement

Item

≥1.5 x 109/l, platelets ≥100 x 109/l

boolean

C0032181 (UMLS CUI [1])

Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement

Item

adequate liver function: bilirubin ≤1.5 x upper limit of normal (unl) range, alat and/or asat ≤2.5 x unl, alkaline phosphatase ≤5 x unl

boolean

C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201899 (UMLS CUI [4])
C0201850 (UMLS CUI [5])

Renal function | Estimation of creatinine clearance by Cockcroft-Gault formula

Item

adequate renal function: the calculated creatinine clearance should be ≥50 ml/min

boolean

C0232804 (UMLS CUI [1])
C2711451 (UMLS CUI [2])

Patient Available Therapeutic procedure | Patient Available Follow-up

Item

patients must be accessible for treatment and follow-up

boolean

C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])

Informed Consent

Item

written informed consent according to the local ethics committee requirements

boolean

C0021430 (UMLS CUI [1])

Quality of life Questionnaire Completion

Item

willing to fill in quality of life questionnaires

boolean

C0034380 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])

Able to read Dutch Language | Able to write Dutch Language

Item

able to read and write in dutch

boolean

C0586740 (UMLS CUI [1,1])
C0376241 (UMLS CUI [1,2])
C0584993 (UMLS CUI [2,1])
C0376241 (UMLS CUI [2,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Medical History Invasive carcinoma of breast | Medical History Breast Carcinoma

Item

history of breast cancer (invasive or non-invasive)

boolean

C0262926 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in situ of uterine cervix

Item

previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.

boolean

C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])

Disease Serious | Myocardial Infarction | Sign or Symptom Heart failure | Cardiac Arrhythmia

Item

serious other diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias

boolean

C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C3540840 (UMLS CUI [3,1])
C0018801 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4])

Diabetes Mellitus

Item

diabetes mellitus

boolean

C0011849 (UMLS CUI [1])

Body mass index

Item

body mass index (bmi) < 19 kg/m2

boolean

C1305855 (UMLS CUI [1])

Pregnancy | Breast Feeding

Item

pregnancy or lactating

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

Food Allergy

Item

significant food allergies which would make the subject unable to consume the food provided (ex: nuts or soy)

boolean

C0016470 (UMLS CUI [1])

Metabolic Diseases Affecting Gluconeogenesis | Metabolic Diseases Affecting Adaptation Fasting

Item

any metabolic disorders that may affect gluconeogenesis or adaptation to short fasting periods.

boolean

C0025517 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0017715 (UMLS CUI [1,3])
C0025517 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0392673 (UMLS CUI [2,3])
C0015663 (UMLS CUI [2,4])

Medical condition Preventing Completion of clinical trial | Mental condition Preventing Completion of clinical trial | Medical condition Preventing Informed Consent | Mental condition Preventing Informed Consent

Item

medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

boolean

C3843040 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0021430 (UMLS CUI [4,3])

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Eligibility Fasting Mimicking Diet NCT02126449