Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug305 | Anakinra and Zinc Wiki | 0.71 |
| drug3480 | Quality Improvement Wiki | 0.71 |
| drug3364 | Prednisone Wiki | 0.27 |
Navigate: Correlations HPO
There are 2 clinical trials
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
Description: The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.
Measure: Survival at 90 days Time: 90 daysDescription: Score will be calculated using the following website: https://www.mdcalc.com/lille-model-alcoholic-hepatitis (exp(-R))/(1 + exp(-R)) where the variables are as follows: R = 3.19 - 0.101*(age, years) + 0.147*(albumin day 0, g/L) + 0.0165* (evolution in bilirubin level, µmol/L) - 0.206*(renal insufficiency) - 0.0065*(bilirubin day 0, µmol/L) - 0.0096*(PT, sec) Renal insufficiency = 1 (if Cr >1.3 mg/dL (115 µmol/L)) or 0 (if ≤1.3 mg/dL (115 µmol/L))
Measure: Changes is Lille score Time: 7, 30, and 90 daysDescription: The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
Measure: Changes in MELD score Time: 7, 30, and 90 daysDescription: Increase in creatinine of 50% above baseline over a period of 7 days Increase in creatinine of 0.3 mg/dl within a period of 48 hrs Onset of renal failure requiring dialysis
Measure: Progression of the development of AKI (acute kidney injury) Time: 7, 30, and 90 daysDescription: Defined as failure ≥2 organs
Measure: Progression of the development of multi-organ failure Time: 7, 30, and 90 daysDescription: Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 points
Measure: Progression of the development of SIRS (Systemic Inflammatory Response Syndrome) Time: 7, 30, and 90 daysDescription: Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalation
Measure: Number of Transfers to ICU Time: 7, 30, and 90 daysDescription: New onset of ascites if not present on admission to study New onset of variceal hemorrhage New onset of hepatic encephalopathy (HE).
Measure: Rate of changes in liver function Time: 7, 30, and 90 daysDescription: The SOFA score will be modified and re-evaluated without platelet counts given that these are usually low in AH.
Measure: Measure of changes in sequential organ failure Assessment (SOFA) scores and proportions requiring hemodynamic support for MAP < 65 mm Hg and lactate > 2 mmol/l, renal replacement therapy or mechanical ventilation. Time: 180 daysDescription: Pneumonia defined as new infiltrate by CXR or Chest CT scan not explained by "fluid overload" Positive blood cultures for bacteria or fungus, not suspected as contaminant Positive urine fungal culture > 50,000 colonies/ml Positive urine bacterial culture > 100,000 colonies/ml (mixed flora is excluded) Soft tissue or bone infections including cellulitis or abscess documented by exam or scan CNS infection defined as positive culture of CSF or > 5 WBC/ml Ascitic fluid white cell count >500/ml or neutrophils>250/ml. with or without positive bacterial or fungal cultures
Measure: Measuring the types of infections Time: 180 daysDescription: Life-threatening organ dysfunction caused by a dysregulated host response to infection An increase in SOFA score of 2 points of more Note: most participants with severe AH have 4 points based on bilirubin only
Measure: Rate of the progression of sepsis Time: 180 daysDescription: Defined by a creatinine > 2 mg/dl
Measure: Rate of the progression of renal dysfunction Time: 180 daysDescription: Proportion of participants requiring transfer to ICU for care, intubation for airway control, need for ventilator support or RRT.
Measure: Need for care escalation Time: 180 daysCurrently, there is a lack of literature on programs evaluating rapid screening methods to traditional venipuncture methods for sample collection during screening for viral hepatitis. Due to the relatively low diagnosis and linkage to care rate, screening programs that provide same day results for viral hepatitis infection may improve both diagnosis and enable providers to engage patients shortly after diagnosis. This stands in contrast to the multi-visit, weeks long process that normally accompanies serum testing for hepatitis C virus (HCV) and hepatitis B virus (HBV). A few American studies have examined the implementation of HCV inpatient screening programs; however, they are focused specifically on high-risk patient populations, the barriers to accessing care experienced by study participants are not relevant to the Canadian healthcare system context, and do not use rapid testing. Furthermore, there are few, if any, data on HBV inpatient screening programs and the diagnosis rate remains low. This project will provide key data on a rapid inpatient screening and linkage to care strategy as well as the prevalence of these viruses across different age bands within the population. Finally, the study will help determine whether rapid inpatient screening is a feasible and acceptable approach for screening and linkage to care.
Description: To determine the proportion of HCV antibody positive participants who complete HCV RNA PCR in each arm. Participants will be contacted at 90 days and 1 year post-enrolment to self-report progress.
Measure: Number of HCV antibody positive participants who complete an HCV RNA PCR. Time: 2 yearDescription: To determine the proportion of HCV RNA positive participants successfully linked to care from each arm. Participants will be contacted at 90 days and 1 year post-enrolment to self-report.
Measure: Number of HCV RNA positive participants who attend their first hepatology appointment. Time: 2 yearDescription: To determine the proportion of HCV RNA positive participants who successfully achieved a sustained virological response at 12 weeks (SVR12) after treatment completion. Participants will be contacted at 90 days and 1 year post-enrolment to self-report.
Measure: Number of HCV RNA positive participants who achieve a Sustained Virological Response at 12 weeks (SVR12) after treatment completion. Time: 2 yearDescription: Proportion of screened participants who are positive and chronically infected in general internal medicine inpatient units.
Measure: Number of chronic hepatitis C and hepatitis B infection in the general internal medicine inpatient units. Time: 1 yearDescription: To determine acceptability of implementing hepatitis C and hepatitis B screening in general internal medicine inpatient units.
Measure: Number of patients willing to participate in hepatitis C and hepatitis B screening in general internal medicine inpatient units. Time: 1 yearDescription: To determine the effect of hepatitis C and hepatitis B screening on hospital staff workflow in general internal medicine inpatient units.
Measure: Percentage of physicians, residents, and nurses who believe that hepatitis C and hepatitis B screening can be incorporated into the general internal medicine inpatient units' workflow. Time: 1 yearDescription: To determine whether results of the Cepheid Xpert® HCV Viral Load assay are valid when compared to the standard commercial assay for HCV RNA PCR.
Measure: Proportion of Cepheid Xpert® HCV Viral Load test results matching test results from the standard commercial assay for HCV RNA PCR. Time: 1 yearDescription: To determine the historical rate of HCV screening and chronic HCV infection in general internal medicine inpatient units.
Measure: Retrospective rates of HCV testing, HCV antibody positive results, and HCV RNA positive results in general internal medicine inpatient units. Time: 1 yearAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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