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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1692 | Hand sanitizer and hand washing Wiki | 0.58 |
| drug817 | CYP 450 Substrates Wiki | 0.58 |
| drug146 | ATI-1777 Wiki | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D004485 | Eczema NIH | 1.00 |
| D003872 | Dermatitis NIH | 0.87 |
| D012868 | Skin Abnormalities NIH | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000964 | Eczema HPO | 1.00 |
| HP:0001047 | Atopic dermatitis HPO | 1.00 |
| HP:0011123 | Inflammatory abnormality of the skin HPO | 0.87 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000951 | Abnormality of the skin HPO | 0.41 |
Navigate: Correlations HPO
There are 3 clinical trials
Hand washing and the use of hand sanitizers are important interventions in disease prevention. Engaging in frequent hand washing is especially effective in preventing the spread of viruses, as this removes microbes and prevents the spread to others. Hand dermatitis, however, is a common occurrence in certain occupations, such as healthcare workers. With the onset of the SARS-CoV2 (COVID-19) pandemic, hand hygiene measures are further enforced as there is no cure or vaccine for this virus. In the study, the effects of hand washing and the use of hand sanitizer on skin proteins and lipids will be assessed.
Description: Skin barrier assessments at baseline, then after hand sanitizer use will be performed. Analysis of skin filaggrin breakdown products, lipid profiles, and transepidermal water loss will be compared.
Measure: Measure the change in transepidermal water loss and skin components after using hand sanitizer. Time: Through study completion, up to 1 yearDescription: Skin barrier assessments after hand washing with soap and water will be performed. Analysis of skin filaggrin breakdown products, lipid profiles, and transepidermal water loss will be compared.
Measure: Measure the change in transepidermal water loss and skin components after hand washing with soap and water. Time: Through study completion, up to 1 yearDescription: Questionnaires will capture symptoms of hand dryness, frequency of hand washing, and other environmental exposures. This data will be compared to the degree of transepidermal water loss and skin barrier findings.
Measure: Individual reporting of hand dryness and environmental exposures Time: Through study completion, up to 1 yearThe purpose of this study is to evaluate the effect of nemolizumab (CD14152) on the pharmacokinetics (PK) of a drug "cocktail" representative of CYP450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5 sensitive index substrates) in adult participants with moderateto- severe atopic dermatitis (AD).
Description: Change of AUC (0-infinity) of each of the 5 probe drugs before and after 9-week nemolizumab treatment will be assessed. AUC (0-infinity) is defined as AUC from time 0 to infinity, calculated as the sum of AUC (0-last) and C(last)/lambda(z); where C(last) is the last observed measurable (non-BQL) concentration; and lambda(z) is apparent terminal elimination rate constant.
Measure: Change of Area Under the Concentration-time Curve from Time Zero to Infinity (AUC[0-infinity]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment Time: Baseline (Week 0) and Week 10: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'Description: Change of AUC (0-last) of each of the 5 probe drugs before and after 9-week nemolizumab treatment will be assessed. AUC (0-last) is defined as AUC from time 0 to the time of the last measurable (non-below quantification limit [non-BQL]) concentration, calculated by linear-linear trapezoidal summation.
Measure: Change of Area Under the Concentration-time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC [0-last]) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment Time: Baseline (Week 0) and Week 10: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'Description: Change of Cmax of each of the 5 probe drugs before and after 9-week nemolizumab treatment will be assessed. Cmax is defined as the maximum observed plasma concentration.
Measure: Maximum Observed Plasma Concentration (Cmax) of Each of the 5 Probe Drugs Before and After 9-week Nemolizumab Treatment Time: Baseline (Week 0) and Week 10: Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 72 and 120 hours post-dose'Description: Incidence of AEs including treatment emergent AEs (TEAEs), AEs of special interest (AESIs), and serious AEs (SAEs) will be reported. An AE is defined as any untoward medical occurrence in a study participant administered a medicinal product which does not necessarily have a causal relationship with this treatment. SAE is any untoward medical occurrence that at any dose may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. A TEAE is defined as an AE that occurs on or after the first date of study drug(s) administration until the date of last study visit. An AESI is a noteworthy treatment-emergent event for the study drug that should be monitored closely and reported promptly.
Measure: Incidence of Adverse Events (AEs) Time: Up to 24 weeksDescription: The severity of AEs including TEAEs, AESIs, and SAEs will be assessed as mild, moderate or severe.
Measure: Severity of Adverse Events (AEs) Time: Up to 24 weeksThis is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following twice-daily applications to target areas of patients with moderate or severe atopic dermatitis.
Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.
Measure: Percent change from baseline in EASI score at Day 28 Time: Baseline to Day 28Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.
Measure: Percent change from baseline in EASI score at Day 8 Time: Baseline to Day 8Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.
Measure: Percent change from baseline in EASI score at Day 15 Time: Baseline to Day 15Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.
Measure: Proportion of patients who achieve 50% improvement in EASI score (EASI 50) within 28 days of the start of treatment Time: Day 28Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.
Measure: Proportion of patients who achieve 75% improvement in EASI score (EASI-75) within 4 weeks of the start of treatment Time: Baseline to Day 28Description: EASI = Eczema Area and Severity Index. The EASI evaluation is performed by the Principal Investigator and will evaluate Atopic Dermatitis in each of 3 body regions (trunk [excluding groin and genitalia], upper extremities [excluding palms of hands], and lower extremities [excluding soles of feet]). The EASI scoring system uses a defined process to grade the severity of the signs of AD and the extent affected. EASI Scores range from 0-72, with higher score indicative of more severe disease.
Measure: Proportions of patients who achieve 90% improvement in EASI score (EASI-90) within 4 weeks of the start of treatment Time: Baseline to Day 28Description: IGA = Validated Investigator Global Assessment scale for Atopic Dermatitis. The IGA is the investigator's assessment of the average overall severity of patient's AD at a particular point in time. Scores range from 0-4, with higher scores indicative of more severe disease.
Measure: Change from baseline in IGA score at Day 8 Time: Baseline to Day 8Description: IGA = Validated Investigator Global Assessment scale for Atopic Dermatitis. The IGA is the investigator's assessment of the average overall severity of patient's AD at a particular point in time. Scores range from 0-4, with higher scores indicative of more severe disease.
Measure: Change from baseline in IGA score at Day 15 Time: Baseline to Day 15Description: IGA = Validated Investigator Global Assessment scale for Atopic Dermatitis. The IGA is the investigator's assessment of the average overall severity of patient's AD at a particular point in time. Scores range from 0-4, with higher score indicative of more severe disease. 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.
Measure: Change from baseline in IGA score at Day 28 Time: Baseline to Day 28Description: BSA = Percent of Body Surface Area of Atopic Dermatitis. The total percentage of the patient's BSA affected by AD will be estimated by the investigator or designee using the handprint method, which estimates that the area of a patient's full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores range from 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.
Measure: Change from baseline in BSA at Day 8 Time: Baseline to Day 8Description: BSA = Percent of Body Surface Area of Atopic Dermatitis. The total percentage of the patient's BSA affected by AD will be estimated by the investigator or designee using the handprint method, which estimates that the area of a patient's full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores range from 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.
Measure: Change from baseline in BSA at Day 15 Time: Baseline to Day 15Description: BSA = Percent of Body Surface Area of Atopic Dermatitis. The total percentage of the patient's BSA affected by AD will be estimated by the investigator or designee using the handprint method, which estimates that the area of a patient's full handprint (fingers and thumbs together) constitutes 1% of their total BSA. Scores range from 0-100%, with higher score indicative of increased percentage of atopic dermatitis on the skin.
Measure: Change from baseline in BSA at Day 28 Time: Baseline to Day 28Description: PP-NRS = Peak Pruritus Numerical Rating Scale. The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores range from 0-10, with higher scores indicative of more severe itching.
Measure: Change from baseline in PP-NRS score at Day 8 Time: Baseline to Day 8Description: PP-NRS = Peak Pruritus Numerical Rating Scale. The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores range from 0-10, with higher scores indicative of more severe itching.
Measure: Change from baseline in PP-NRS at Day 15 Time: Baseline to Day 15Description: PP-NRS = Peak Pruritus Numerical Rating Scale. The PP-NRS is a single patient-reported item designed to measure peak pruritus, or 'worst' itch, over the previous 24 hours. Scores range from 0-10, with higher scores indicative of more severe itching.
Measure: Change from baseline in PP-NRS score at Day 28 Time: Baseline to Day 28Description: Laboratory measure will be categorized as normal, high, or low. Normal laboratory values represent better outcomes. Laboratory measures include White Blood Cell (WBC) Count, Absolute Neutrophil Count (ANC), Aspartate Aminotransferase, Lymphocyte count, Platelet count, Hemoglobin, and Serum creatinine. The status at the final value at the end of the treatment period will be compared with that at the study baseline and the "shifts" from study baseline will be summarized using the number and percentage of patients in each shift category by treatment group.
Measure: Proportion of Subjects Experiencing a Shift from Baseline Laboratory Values Time: Baseline to Day 28Description: Laboratory measure will be summarized using descriptive statistics for numeric variables and numbers and percentages for categorical variables at each scheduled assessment. Numeric hematology, chemistry, and urinalysis results will be summarized using change from baseline as well.
Measure: Summary of Hematology at Day 28 Time: Baseline to Day 28Description: Laboratory measure will be summarized using descriptive statistics for numeric variables and numbers and percentages for categorical variables at each scheduled assessment. Numeric hematology, chemistry, and urinalysis results will be summarized using change from baseline as well.
Measure: Summary of Serum Chemistry at Day 28 Time: Baseline to Day 28Description: Laboratory measure will be summarized using descriptive statistics for numeric variables and numbers and percentages for categorical variables at each scheduled assessment. Numeric hematology, chemistry, and urinalysis results will be summarized using change from baseline as well.
Measure: Summary of Urinalysis at Day 28 Time: Baseline to Day 28Description: Vital signs will be presented descriptively. Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.
Measure: Summary of Abnormal Vital Signs at Day 8 Time: Baseline to Day 8Description: Vital signs will be presented descriptively. Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.
Measure: Summary of Abnormal Vital Signs at Day 15 Time: Baseline to Day 15Description: Vital signs will be presented descriptively. Vital signs will be measured in a semi-supine position after 5 minutes of rest and will include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.
Measure: Summary of Abnormal Vital Signs at Day 28 Time: Baseline to Day 28Description: ECG = Electrocardiogram. Clinically significant ECG findings include, but not limited to, ectopic atrial rhythm, clinically significant conduction disturbance including PR >240 msec, pre-excitation (delta wave and PR < 120 msec), second degree or higher atrioventricular block, new finding of QRS > 120 ms, evidence of of QT-interval prolongation, and acute signs of ischemia or infarction.
Measure: Summary of Abnormal Physical 12-lead ECG reading at Day 28 Time: Baseline to Day 28Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports