|drug2874||lulizumab pegol Wiki||0.45|
|drug2904||mycophenolate mofetil Wiki||0.45|
|drug167||Anakinra and Zinc Wiki||0.45|
|drug2906||mycophenolic acid Wiki||0.45|
|drug2742||antithymocyte globulin (rabbit) Wiki||0.45|
|drug641||Control group Wiki||0.26|
|D006506||Hepatitis A NIH||0.45|
|D006519||Hepatitis, Alcoholic NIH||0.45|
|D011024||Pneumonia, Viral NIH||0.06|
|D045169||Severe Acute Respiratory Syndrome NIH||0.02|
|D018352||Coronavirus Infections NIH||0.02|
There are 5 clinical trials
The purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients.
Description: Definitions: Acute T cell Mediated Rejection: Biopsy proven rejection defined by histologic evidence of a Banff grade of ≥1A and clinical treatment for acute rejection. Acute Antibody Mediated Rejection: Diffusely positive immunostaining staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms.Measure: Proportion of participants who remain free of biopsy-proven acute T-cell mediated or antibody-mediated rejection as defined by Banff criteria Time: 6 months post transplantation
Description: Definitions: Acute T cell Mediated Rejection: Biopsy proven rejection defined by histologic evidence of a Banff grade of ≥1A and clinical treatment for acute rejection. Acute Antibody Mediated Rejection: Diffusely positive immunostaining staining for C4d, presence of circulating anti-donor antibodies, and morphologic evidence of acute tissue injury. Reference: Banff 2007 Classification Renal Allograft Pathology definition of terms.Measure: Proportion of participants who remain free of biopsy-proven acute T-cell mediated or antibody-mediated rejection as defined by Banff criteria Time: 12 months post transplantation
Description: Mechanistic assay. Evaluation of the frequency of circulating Tregs over time.Exploratory goal: To advance understanding in mechanisms of tolerance.Measure: EXPLORATORY: Frequency of circulating T Regulatory Cells (Tregs) Time: Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation
Description: Mechanistic assay.Donor-specific suppression activity of recipient Tregs will be measured over time by using irradiated donor peripheral blood mononuclear cells (PBMCs) as stimulators. Exploratory goal: To advance understanding in mechanisms of tolerance.Measure: EXPLORATORY:T Regulatory Cells (Treg) suppressive activity Time: Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation
Description: Mechanistic assay that measures the frequency of circulating donor-reactive CD4 conventional T cells, CD8 T cells and Tregs analyzed over time. Exploratory goal: To advance understanding in mechanisms of tolerance.Measure: EXPLORATORY:Alloreactive T cell frequency Time: Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation
Description: Methodology: Analysis of gene expression in peripheral blood mononuclear cells (PBMCs) stimulated with donor antigen presenting cells to explore genes implicated in T cell checkpoint inhibition (CTLA-4, SFASL, NFATC1, NFATC2, LAG3 and HAVCR2, as examples). Exploratory goal: To advance understanding in mechanisms of tolerance.Measure: EXPLORATORY:Expression of T cell checkpoint inhibition related genes Time: Day 0 (Pre-transplant) and -3, -6 and -12 months post transplantation
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 days
Description: 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 days
Description: 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 days
Description: 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 dialysisMeasure: Progression of the development of AKI (acute kidney injury) Time: 7, 30, and 90 days
Description: Defined as failure ≥2 organsMeasure: Progression of the development of multi-organ failure Time: 7, 30, and 90 days
Description: Defined as two or more abnormalities in temperature, increased heart rate, respiration, or white blood cell count with increase in SOFA score ≥2 pointsMeasure: Progression of the development of SIRS (Systemic Inflammatory Response Syndrome) Time: 7, 30, and 90 days
Description: Recording the change of hospital word from regular floor to ICU floor as a marker for worsening illness and care escalationMeasure: Number of Transfers to ICU Time: 7, 30, and 90 days
Description: 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 days
Description: 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 days
Description: 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 culturesMeasure: Measuring the types of infections Time: 180 days
Description: 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 onlyMeasure: Rate of the progression of sepsis Time: 180 days
Description: Defined by a creatinine > 2 mg/dlMeasure: Rate of the progression of renal dysfunction Time: 180 days
Description: 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 days
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease. During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection. The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome. The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.
Description: SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.Measure: Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. Time: 7 days
Description: level1: not hospitalized no limited activities, level 7: deathMeasure: disease severity assessed on a 7-level ordinal scale Time: 7 days
Description: Reduction of radiological signs on chest imagingMeasure: radiological signs on chest imaging Time: 7 days
Description: duration on daysMeasure: Duration of oxygen therapy Time: 21 days
To date, there is no efficient therapeutics to prevent or treat COVID-19 related pulmonary failure. Corticosteroids (CS) could be a helpful therapeutic. Retrospective reports suggested survival improvement in patients with acute respiratory distress syndrome (ARDS). CT scan for COVID19 hospitalized patients showed sometimes unusual aspects of pneumonia, suggestive of an organizing phase of diffuse alveolar damage (DAD). We hypothesize that, in the context of alveolar aggression induced by COVID-19, CT scan could help to individualize patients with a high probability of pulmonary organizing process who could benefit from CS treatment.
Description: The 7-category ordinal scale is as follow: Not hospitalized with resumption of usual activities Not hospitalized, but unable to resume usual activities Hospitalized, not requiring O2 Hospitalized, requiring O2 from 1 to 5 l/min Hospitalized, requiring O2 >6 l/min, nasal high-flow O2, non-invasive mechanical ventilation, or both Hospitalized, requiring ECMO, invasive mechanical ventilation, or both Death.Measure: Clinical improvement defined by the improvement of 2 points on a 7-category ordinal scale, at 14 days. Time: 14 days
Steroids has shown benefits in COVID19 patients in observational studies. We hypothesized that early use of corticosteroids, low dose, can reduce progression of respiratory failure and death.