CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


HP:0001395: Hepatic fibrosisHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)


Name (Synonyms) Correlation
drug762 Diet tracking and survey Wiki 0.50
drug869 Esomeprazole 20mg Wiki 0.50
drug809 EHR-based Clinician Jumpstart Wiki 0.50
drug2915 no intervention Wiki 0.20
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (15)


Name (Synonyms) Correlation
D008103 Liver Cirrhosis, NIH 1.00
D005355 Fibrosis NIH 0.45
D014652 Vascular Diseases NIH 0.35
D016491 Peripheral Vascular Diseases NIH 0.35
D058729 Peripheral Arterial Disease NIH 0.29
D009362 Neoplasm Metastasis NIH 0.29
D051437 Renal Insufficiency, NIH 0.25
D008175 Lung Neoplasms NIH 0.25
D007676 Kidney Failure, Chronic NIH 0.20
D006333 Heart Failure NIH 0.19
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.18
D017563 Lung Diseases, Interstitial NIH 0.16
D002908 Chronic Disease NIH 0.16
D008171 Lung Diseases, NIH 0.13
D009369 Neoplasms, NIH 0.11

Correlated HPO Terms (8)


Name (Synonyms) Correlation
HP:0000083 Renal insufficiency HPO 0.25
HP:0100526 Neoplasm of the lung HPO 0.25
HP:0004950 Peripheral arterial stenosis HPO 0.22
HP:0001635 Congestive heart failure HPO 0.19
HP:0006510 Chronic pulmonary obstruction HPO 0.18
HP:0006515 Interstitial pneumonitis HPO 0.16
HP:0002088 Abnormal lung morphology HPO 0.13
HP:0002664 Neoplasm HPO 0.11

There are 4 clinical trials

Clinical Trials


1 Using the Electronic Health Record to Identify and Promote Goals-of-Care Communication for Older Patients With Serious Illness

The objective of this protocol is to test the effectiveness of a Jumpstart intervention on patient-centered outcomes for patients with chronic illness by ensuring that they receive care that is concordant with their goals over time, and across settings and providers. This study will examine the effect of the EHR-based intervention to improve quality of palliative care for patients over the age of 65 with chronic, life-limiting illness with a particular emphasis on Alzheimer's disease and related dementias (ADRD). The specific aims are: 1) to evaluate the effectiveness of a novel EHR-based (electronic health record) clinician Jumpstart guide, compared with usual care, for improving the quality of care; the primary outcome is documentation of a goals-of-care discussion during the hospitalization. Secondary outcomes focus on intensity of care: ICU use, ICU and hospital length of stay, costs of care during the hospitalization, and 30-day hospital readmissions; and 2) to conduct a mixed-methods evaluation of the implementation of the Jumpstart intervention, guided by the RE-AIM and CFIR frameworks for implementation science, incorporating quantitative assessments of effectiveness, implementation and maintenance and qualitative assessments of clinician perspectives on barriers and facilitators to future implementation and dissemination.

NCT04281784 Dementia Chronic Disease Neoplasm Metastasis Lung Neoplasm Pulmonary Disease, Chronic Obstructive Heart Failureļ¼ŒCongestive Liver Cirrhosis Kidney Failure, Chronic Lung Diseases, Interstitial Peripheral Vascular Disease Diabetes With End Organ Injury Palliative Care, Patient Care Health Care Quality, Access, and Evaluation Patient Care Inpatients Health Communication Patient Care Planning Behavioral: EHR-based Clinician Jumpstart
MeSH:Neoplasm Metastasis Lung Neoplasms Liver Cirrhosis Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Interstitial Renal Insufficiency Kidney Failure, Chronic Heart Failure Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Chronic Disease Neoplasms
HPO:Abnormal lung morphology Chronic pulmonary obstruction Cirrhosis Congestive heart failure Hepatic fibrosis Interstitial pneumonitis Interstitial pulmonary abnormality Left ventricular dysfunction Neoplasm Neoplasm of the lung Peripheral arterial stenosis Renal insufficiency Right ventricular failure

Primary Outcomes

Description: The primary outcome is the proportion of patients who have a goals-of-care (GOC) discussion that has been documented in the EHR in the period between randomization and 30 days following randomization The proportion is the number of patients with GOC documentation over the number of patients in each study arm. Documentation of goals-of-care discussions will be evaluated using our NLP/ML methods. Study staff will manually review and compare findings using a randomly-selected sample of charts using our standard EHR abstraction methods; manual chart abstraction will be the gold standard.

Measure: EHR documentation of Goals of Care discussions

Time: Assessed for the period between randomization and 30 days following randomization

Secondary Outcomes

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU admissions during the patient's (index) hospital stay will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care/ICU use: ICU admissions

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the ICU during their (index) hospital stay will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care/ICU use: ICU length of stay

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of days the patient spent in the hospital during that (index) hospital stay will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care/Hospital use: Hospital length of stay

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of hospital readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care: Hospital Readmissions 30 days

Time: Assessed for the period between randomization and 30 days following randomization

Description: Secondary outcomes include measures of intensity of care, including utilization metrics: Number of ICU readmissions between randomization and 30 days following randomization will be collected from the EHR using our automated and validated methods.

Measure: Intensity of care: ICU Readmissions 30 days

Time: Assessed for the period between randomization and 30 days following randomization

Description: Costs for intervention vs. control will be reported in US dollars and identified from UW Medicine administrative financial databases. Costs will be reported for total hospital costs and disaggregated costs (direct-variable, direct fixed, indirect costs). Direct-variable costs will include supply and drug costs. Direct-fixed costs will include labor, clinical department administration, and overhead fees. Indirect costs represent services provided by cost centers not directly linked to patient care such as information technology and environmental services. Costs for ED (emergency department) days and ICU days will be similarly assessed.

Measure: Intensity of care: Healthcare costs

Time: 1 and 3 months after randomization

Description: From Washington State death certificates.

Measure: All-cause mortality at 1 year (safety outcome)

Time: 1 year after randomization

Other Outcomes

Description: Qualitative interviews after individual participation. Interviews will be guided by the RE-AIM and Consolidated Framework for Implementation Research (CFIR) to explore the factors associated with implementation (e.g., reach, maintenance, feasibility, inner and outer settings, individuals, and processes of care.) Individual constructs within these domains were chosen to fit this specific intervention and context.

Measure: Key Implementation Factors

Time: 3 months after randomization

2 Clinical Characteristics of COVID-19 in Patients With Pre-existing Cirrhosis (COVID-Cirrhosis-CHESS2002): A Multicentre Observational Study

COVID-19 pandemic with SARS-CoV-2 infection has become a global challenge. Though most cases of COVID-19 are mild, the disease can also be fatal. Patients with liver cirrhosis are more susceptible to damage from SARS-CoV-2 infection considering their immunocompromised status. The spectrum of disease and factors that influence the disease course in COVID-19 cases with liver cirrhosis are incompletely defined. This muilticentre observational study (COVID-Cirrhosis-CHESS2002) aims to study the clinical characteristics and risk factors associated with specific outcomes in COVID-19 patients with pre-existing liver cirrhosis.

NCT04329559 COVID-19 Liver Cirrhosis
MeSH:Liver Cirrhosis Fibrosis
HPO:Cirrhosis Hepatic fibrosis

Primary Outcomes

Description: 7-day, 28-day, 60-day, 180-day and 365-day all-cause mortality of COVID-19 patients with liver cirrhosis

Measure: All-cause mortality of COVID-19 patients with liver cirrhosis

Time: From illness onset of COVID-19 to death from any cause, up to 365 days

Secondary Outcomes

Description: 7-day, 28-day, 60-day, 180-day and 365-day liver-related mortality of COVID-19 patients with liver cirrhosis

Measure: Liver-related mortality of COVID-19 patients with liver cirrhosis

Time: From illness onset of COVID-19 to death from liver-related cause, up to 365 days

Description: Risk factors (laboratory findings, imaging findings, etc.) associated with specific outcomes (death, etc.) of COVID-19 patients with liver cirrhosis

Measure: Risk factors associated with specific outcomes of COVID-19 patients with liver cirrhosis

Time: From hospital admission to death, up to 365 days

Description: Baseline characteristics (laboratory findings, imaging findings, etc.) of COVID-19 patients with liver cirrhosis

Measure: Baseline characteristics of COVID-19 patients with liver cirrhosis

Time: 1 Day

3 The Spectrum and Profile of COVID-19 Infection and Its Impact on Liver - The Pan Asia-Pacific Prospective Multi-centre Observational Study (APCOLIS STUDY)

To address the existing deficiencies in the knowledge regarding liver involvement and spectrum of clinical presentation and the impact of COVID-19 infection in patients of liver disease was planned. The present study will be a hospital based and the cases of confirmed COVID-19 infection will be evaluated in relation to liver involvement irrespective of pre-existing liver disease. The primary objective was to address the clinical presentation, biochemical alteration and outcomes of COVID-19 infection in subjects with chronic hepatitis, cirrhosis in comparison to those having infection in the absence of pre-existing liver disease

NCT04345640 Liver Cirrhoses Other: no intervention
MeSH:Liver Cirrhosis
HPO:Cirrhosis Hepatic fibrosis

Primary Outcomes

Measure: Spontaneous recovery or death in both groups

Time: 90 days

Secondary Outcomes

Measure: Severity of prior as well as present decompensation in both groups

Time: 90 days

Measure: Duration of prior as well as present decompensation in both groups

Time: 90 days

Measure: Improvement in severity assessment Indices Model for End Stage Liver Disease (MELD) scores in both groups

Time: 90 days

Measure: Improvement in severity assessment Indices Child-Turcotte-Pugh (CTP) scores in both groups

Time: 90 days

Measure: Improvement in severity assessment Indices Sequential Organ Failure Assessment (SOFA) scores in both groups

Time: 90 days

Measure: Improvement in severity assessment Indices Acute Physiology And Chronic Health Evaluation (APACHE) scores II in both groups

Time: 90 days

Measure: Improvement in severity assessment Indices Chronic Liver Failure-Sequential Organ Failure Assessment (CLIF SOFA) scores in both groups.

Time: 90 days

4 Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

Proton-pump inhibitors (PPI) are commonly prescribed in an uncritical manner to patients with liver cirrhosis without a clear evidence-based indication. Observational studies suggests that PPI use in cirrhotic patients may be a risk factor for the development of infections, especially spontaneous bacterial peritonitis (SBP). A possible explanation are PPI-associated microbiotic shifts leading to small intestinal bacterial overgrowth with subsequently increased bacterial translocation. Furthermore, PPI therapy in cirrhotic patients may lead to an increased risk for pneumonia and Clostridium difficile-infections. However, the evidence is ambiguous, as other published studies found no evidence for an association of PPI use with an increased risk for SBP or pneumonia. Moreover, an association between episodes of hepatic encephalopathy and PPI use has been reported. Infections and hepatic encephalopathy may often lead to a hospitalization of cirrhotic patients and PPI use at discharge has also been associated to early re-hospitalization. While some studies found an association of PPI and increased mortality in cirrhotic patients, other studies could not observe this association. Thus, some of the current evidence suggests an unfavourable risk profile of PPIs in patients with liver cirrhosis. However, this patient population is considered to be at a high risk of gastrointestinal haemorrhage from peptic ulcers. Importantly, patients with liver cirrhosis have an increased mortality after peptic ulcer bleeding as compared to patients without cirrhosis. Therefore, generous PPI use may also have a yet unproven preventive effect against upper gastrointestinal bleeding. The STOPPIT trial is the first prospective, randomized, controlled, double-blind trial investigating the effect of discontinuation of long-term PPI therapy on hospitalized patients with complicated liver cirrhosis with a pre-existing long-term PPI therapy. Importantly, patients with an evidence-based indication for PPI therapy are excluded from the trial. All study participants (n=476) stop their previous PPI treatment and are then randomized (1:1) to receive either placebo (intervention group) or esomeprazole 20mg/day (control group) for 360 days. The primary hypothesis anticipates a delay of re-hospitalisation and/or death (composite endpoint) in patients who discontinue PPI treatment as compared to patients who continue PPI therapy. Secondary objectives include the assessment of mortality, re-hospitalisation rates, infection rates, rate of acute hepatic decompensation and ACLF, as well as rates of upper and lower gastrointestinal bleeding events in both groups. Impact of prolonged or discontinued PPI therapy on the intestinal microbiota and pharmacoeconomics will be studied as a secondary assessment.

NCT04448028 Liver Cirrhosis Drug: Placebo Drug: Esomeprazole 20mg
MeSH:Liver Cirrhosis Fibrosis
HPO:Cirrhosis Hepatic fibrosis

Primary Outcomes

Measure: Timepoint of first unplanned re-hospitalization or death (whichever occurs first)

Time: Within 12 months (360 days) after randomization

Secondary Outcomes

Measure: Timepoint of death

Time: Within 12 months (360 days) after randomization

Measure: Mortality rate

Time: 360 days after randomization

Measure: Timepoint of first unplanned re-hospitalization

Time: Within 12 months (360 days) after randomization

Measure: Rate of unplanned re-hospitalizations

Time: 360 days after randomization

Measure: Overall infection rate

Time: 360 days after randomization

Description: Infection rates by site of infection (SBP, pneumonia, urinary tract infection, blood stream infection, Clostridium difficile-associated enterocolitis, Norovirus-infection, Sars-CoV-2-infection)

Measure: Infection rates differentiated by site

Time: 360 days after randomization

Measure: Rate of acute decompensation of liver cirrhosis

Time: 360 days after randomization

Measure: Rate of acute-on-chronic liver failure (ACLF)

Time: 360 days after randomization

Measure: Rate of upper gastrointestinal bleeding events

Time: 360 days after randomization

Measure: Rate of lower gastrointestinal bleeding events

Time: 360 days after randomization

Description: The gut microbiota composition will be analyzed by PCR

Measure: Changes of intestinal microbiota between baseline and day 90

Time: 90 days after randomization

Other Outcomes

Measure: Rate of occurence of the safety endpoint (evidence-based indication for open-label re-therapy with PPIs)

Time: 360 days after randomization

Measure: Rate of any (serious) adverse events

Time: 360 days after randomization


HPO Nodes