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The objective of this study is to determine whether the finger tip images captured by the EPIC ClearView device, when analyzed via the ClearView software, produce a Response Scale that characterizes trends consistent with known diagnoses identified by medical doctors. Specifically, the investigators hypothesize that the organ system involving any of a series of known active diagnoses will be identified in the EPIC ClearView Response Scale report with the intention of providing potential triage capabilities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | Men and women ages 18-85 lacking any medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs. | ||
| Five Diagnosis Group | Men and women ages 18-85 with at least one active medical diagnosis (as defined in the protocol) of one or more of the following systems/organs: cardiovascular system; gastrointestinal system; kidneys; liver; lungs. |
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| Measure | Description | Time Frame |
|---|---|---|
| Agreement of ClearView Scan versus Active Diagnosis | Statistical agreement will be assessed between the 0-25 ClearView Response Scale and the physician's diagnoses recorded within the medical record, on a per-subject basis. | At time of ClearView Scan (Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit). |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of ClearView Scan versus Active Diagnosis | Sensitivity and Specificity of the ClearView Scan relative to an active diagnosis, as the proportion of subjects with correctly captured findings amongst those with an active diagnosis and the proportion of subjects without a ClearView finding amongst those without an active diagnosis, respectively. | Single study visit only, with no follow-up. The study endpoint will be reported for day 0, the day of the study visit. |
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Inclusion Criteria:
Five Diagnosis Group:
Sex: Male or Female
Age range: 18 to 85
Qualifying medical diagnoses (5 diagnosis groups)
- For potential subjects presenting with one of the five qualifying diagnoses, the patient presents with confirmed active medical diagnoses affecting the following systems or organs:
The patient or legal representative is able to understand and provide signed consent for the procedure.
Every effort will be given to balance subjects by gender, age, and race. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.
Control Group:
Sex: Male or Female
Age range: 18 to 85
Freedom from qualifying medical diagnoses (control group)
- For potential subjects for the control group, the subject is free from active medical diagnoses affecting the following systems or organs:
The patient or legal representative is able to understand and provide signed consent for the procedure.
Every effort will be given to balance subjects by gender, age, and race. At least 60 subjects from each of the 5 diagnostic groups and the 1 control group will be recruited.
Exclusion Criteria:
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Men and women ages 18-85 who are inpatients, outpatients, friends/family/staff (controls only) of Greater Baltimore Medical Center in Baltimore, Maryland. Participants cannot have an implantable electrical device (such as a pacemaker) on their body, cannot be pregnant, and cannot be undergoing cancer therapy of any kind.
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| Name | Affiliation | Role |
|---|---|---|
| Clair A Francomano, MD | Greater Baltimore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greater Baltimore Medical Cente | Baltimore | Maryland | 21204 | United States |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006333 | Heart Failure |
| D006349 | Heart Valve Diseases |
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| D011704 | Pyelonephritis |
| D058186 | Acute Kidney Injury |
| D051437 | Renal Insufficiency |
| D006519 | Hepatitis, Alcoholic |
| D005234 | Fatty Liver |
| D005355 | Fibrosis |
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001991 | Bronchitis |
| D004646 | Emphysema |
| D011014 | Pneumonia |
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D004238 | Diverticulitis |
| D010437 | Peptic Ulcer |
| D043183 | Irritable Bowel Syndrome |
| D002764 | Cholecystitis |
| D010195 | Pancreatitis |
| D002446 | Celiac Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009395 | Nephritis, Interstitial |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011702 | Pyelitis |
| D052801 | Male Urogenital Diseases |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D008108 | Liver Diseases, Alcoholic |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D000076385 | Diverticular Diseases |
| D004378 | Duodenal Diseases |
| D013272 | Stomach Diseases |
| D003109 | Colonic Diseases, Functional |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D010182 | Pancreatic Diseases |
| D008286 | Malabsorption Syndromes |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
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