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Longitudinal monitoring of inflammation using skin devices may help predict outcomes compared to traditional blood draws
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls | Experimental | Healthy controls will receive the sensors |
|
| Outpatients with cirrhosis | Experimental | Outpatients with cirrhosis will receive the sensors |
|
| Inpatients with cirrhosis | Experimental | Inpatients with cirrhosis will receive the sensors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensor skin | Diagnostic Test | Skin sensor to detect inflammatory molecules in sweat |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | We will study whether subjects have any issues or adverse events related to the sensor | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to detect inflammatory markers (TNF, IL-1b, IL-6 and CRP) using skin sensor compared to blood values | Comparison of skin sensor data to blood inflammatory markers as above using daily blood draw and sensor values. Blood markers and sensor markers will be correlated for each day. | 3 days |
| Linkage of skin inflammatory markers (TNF, IL-6, IL-1b and CRP) with quality of life |
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Healthy Volunteers
Inclusion Criteria:
Exclusion Criteria:
Outpatients with Cirrhosis:
Inclusion criteria:
Age >18 years
Able to give consent
Cirrhosis defined by any one of the following
Exclusion criteria:
Inpatients with Cirrhosis:
Inclusion criteria:
Age >18 years
Able to give consent
Cirrhosis defined by any one of the following
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jasmohan Bajaj, MD | Hunter Holmes McGuire VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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All subjects will receive the sensor but they are 3 different populations, which is why there are 3 different arms
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Correlation of inflammatory markers using the skin sensor data to quality of life using Sickness Impact Profile and PROMIS questionnaires. |
| 3 days |
| Linkage of inflammatory markers (TNF, IL-6, IL-1b and CRP) with cognitive testing | Correlation of inflammatory markers using the skin sensor data to cognitive performance on PHES and EncephalApp Stroop | 3 days |
| Linkage of inflammatory markers with MELD score | Correlation of inflammatory markers using the skin sensor data to MELD score | 3 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |