The demographics Demographics (DM) domain is used to represent information about the participants in a clinical study. Note there are 4 participants in this DM dataset; test results are shown for 1 participant.
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It is important to record the height and weight for patients with DMD since cardiac index and spirometry results are affected by body surface area.[2] The vital signs Vital Signs (VS) dataset contains measurements including but not limited to blood pressure, temperature, respiration, body surface area, body mass index, height, and weight.
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | VSSEQ | VSTESTCD | VSTEST | VSORRES | VSORRESU | VSSTRESC | VSSTRESN | VSSTRESU | VSLOBFXL | VISITNUM | VISIT | VSDTC |
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1 | DMD-EF | VS | DMD-EF-01-101 | 1 | HEIGHT | Height | 47 | in | 119 | 119 | cm |
| 1 | VISIT 1 | 2022-05-16 | 2 | DMD-EF | VS | DMD-EF-01-101 | 2 | WEIGHT | Weight | 20 | kg | 20 | 20 | kg |
| 1 | VISIT 1 | 2022-05-16 | 3 | DMD-EF | VS | DMD-EF-01-101 | 3 | HEIGHT | Height | 52 | in | 132 | 132 | cm |
| 6 | VISIT 6 | 2023-04-06 | 4 | DMD-EF | VS | DMD-EF-01-101 | 4 | WEIGHT | Weight | 32 | kg | 32 | 32 | kg |
| 6 | VISIT 6 | 2023-04-06 |
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The cardiovascular system findings Cardiovascular System Findings (CV) domain contains physiological and morphological findings related to the cardiovascular system.
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Rows 1-8: | Show the baseline CMR ejection fraction measurements for the participant at visit 1. | Rows 9-16: | Show the CMR ejection fraction measurements for the participant at visit 6. |
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Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | CVSEQ | CVLNKID | CVTESTCD | CVTEST | CVORRES | CVORRESU | CVSTRESC | CVSTRESN | CVSTRESU | CVLOC | CVMETHOD | CVLOBXFL | VISITNUM | VISIT | CVDTC | CVDY |
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1 | DMD-EF | CV | DMD-EF-01-101 | 1 |
| ESV | End Systolic Volume | 32 | mL | 32 | 32 | mL | HEART, LEFT VENTRICLE | MRI |
| 1 | VISIT 1 | 2022-05-16 | 1 | 2 | DMD-EF | CV | DMD-EF-01-101 | 2 |
| EDV | End Diastolic Volume | 95 | mL | 95 | 95 | mL | HEART, LEFT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | 3 | DMD-EF | CV | DMD-EF-01-101 | 3 | 2 | LVEF_C | Left Ventricular Ejection Fraction, Cal | 70 | % | 70 | 70 | % | HEART, LEFT VENTRICLE | MRI |
| 1 | VISIT 1 | 2022-05-16 | 1 | 4 | DMD-EF | CV | DMD-EF-01-101 | 4 | 2 | CARDOUT | Cardiac Output | 5.4 | L/min | 5.4 | 5.4 | L/min | HEART, LEFT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | 5 | DMD-EF | CV | DMD-EF-01-101 | 5 |
| ESV | End Systolic Volume | 24 | mL | 24 | 24 | mL | HEART, RIGHT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | 6 | DMD-EF | CV | DMD-EF-01-101 | 6 |
| EDV | End Diastolic Volume | 90 | mL | 90 | 90 | mL | HEART, RIGHT VENTRICLE | MRI |
| 1 | VISIT 1 | 2022-05-16 | 1 | 7 | DMD-EF | CV | DMD-EF-01-101 | 7 | 2 | RVEF_C | Right Ventricular Ejection Fraction, Cal | 75 | % | 75 | 75 | % | HEART, RIGHT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | 8 | DMD-EF | CV | DMD-EF-01-101 | 8 | 2 | CARDOUT | Cardiac Output | 5.6 | L/min | 5.6 | 5.6 | L/min | HEART, RIGHT VENTRICLE | | | 1 | VISIT 1 | 2022-05-16 | 1 | 9 | DMD-EF | CV | DMD-EF-01-101 | 9 |
| ESV | End Systolic Volume | 37 | mL | 37 | 37 | mL | HEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | 10 | DMD-EF | CV | DMD-EF-01-101 | 10 |
| EDV | End Diastolic Volume | 94 | mL | 94 | 94 | mL | HEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | 11 | DMD-EF | CV | DMD-EF-01-101 | 11 | 2 | LVEF_C | Left Ventricular Ejection Fraction, Cal | 65 | % | 65 | 65 | % | HEART, LEFT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | 12 | DMD-EF | CV | DMD-EF-01-101 | 12 | 2 | CARDOUT | Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | HEART, LEFT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | 13 | DMD-EF | CV | DMD-EF-01-101 | 13 |
| ESV | End Systolic Volume | 36 | mL | 36 | 36 | mL | HEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | 14 | DMD-EF | CV | DMD-EF-01-101 | 14 |
| EDV | End Diastolic Volume | 93 | mL | 93 | 93 | mL | HEART, RIGHT VENTRICLE | MRI |
| 6 | VISIT 6 | 2023-04-06 | 326 | 15 | DMD-EF | CV | DMD-EF-01-101 | 15 | 2 | RVEF_C | Right Ventricular Ejection Fraction, Cal | 70 | % | 70 | 70 | % | HEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 | 16 | DMD-EF | CV | DMD-EF-01-101 | 16 | 2 | CARDOUT | Cardiac Output | 4.0 | L/min | 4.0 | 4.0 | L/min | HEART, RIGHT VENTRICLE | | | 6 | VISIT 6 | 2023-04-06 | 326 |
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The lab test, N-terminal pro-Terminal ProBB-type Natriuretic Peptidenatriuretic peptide (NT-proBNP), is a biomarker used in heart failure and ejection fraction for diagnosis and treatment.[3,4] These test results are represented in the laboratory test results Laboratory Test Results (LB) domain.
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Row 1: | Shows the results for the N-Terminal ProB-type Natriuretic Peptide NT-proBNP test at visit 1. | Row 2: | Shows the results for the N-Terminal ProB-type Natriuretic Peptide NT-proBNP test at visit 6. |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBLNKID | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBORNRLO | LBORNRHI | LBSTRESC | LBSTRESN | LBSTRESU | LBSTNRLO | LBSTRNHI | LBNRIND | LBLOINC | LBSPEC | LBLOBXFL | VISITNUM | VISIT | LBDTC | LBDY |
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1 | DMD-EF | LB | DMD-EF-01-101 | 1 | 2 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 40 | pg/mL | 0 | 100 | 40 | 40 | ng/L | 0 | 100 | NORMAL | 71425-3 | BLOOD |
| 1 | VISIT 1 | 2022-05-16 | 1 | 2 | DMD-EF | LB | DMD-EF-01-101 | 2 | 2 | BNPPRONT | N-Terminal ProB-type Natriuretic Peptide | CHEMISTRY | 900 | pg/mL | 0 | 100 | 900 | 900 | ng/L | 0 | 100 | HIGH | 71425-3 | BLOOD |
| 6 | VISIT 6 | 2023-04-06 | 326 |
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A related records Related Records (RELREC) dataset is used to show the relationship between the CV and LB domains.
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