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Filter by:The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.
In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their efficacy and safety in patients under chronic hemodialysis. As the primary target of SGLT2i is expressed mostly in the kidneys, the efficacy of SGLT2i in patients with ESRD may be limited. On the other hand, patients with ESRD are at higher risks of experiencing cardiovascular events and may still benefit from treatment. Several mechanistic studies have demonstrated direct actions of SGLT2i on the myocardium, thus it is possible that the benefits of SGLT2i on heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Furthermore, pharmacokinetics and pharmacodynamics studies on empagliflozin demonstrated that peak plasma levels of empagliflozin in subjects with renal failure/ESRD were similar to those in subjects with normal renal function. The use of empagliflozin in patients with ESRD seemed safe in terms of pharmacokinetics and pharmacodynamics, yet its efficacy remains to be explored.
Open-label pilot study of early inhaled nitric oxide (iNO) for patients developing de novo pulmonary hypertension during Acute Respiratory Distress Syndrome (ARDS.) The study aims to determine whether iNO has possible hemodynamic and clinical benefits when given early in the course of ARDS to patients with evidence of elevated pulmonary artery pressure.
The purpose of this study is to measure the effectiveness of inclisiran compared to usual care in an inclusive study population (women, racial/ethnic minorities, and rural dwelling participants) which has historically been more likely to receive suboptimal lipid management, as a potential solution to improve care gaps. The study duration will be up to 360 days for participants randomized to the inclisiran with usual care arm and up to 720 days for participants initially randomized to the usual care arm.
Alternating hemiplegia of childhood (AHC) is a rare early-onset neurodevelopmental encephalopathy frequently caused by mutations in the ATP1A3 gene. It is typically characterized by a variable degree of intellectual disability, motor dysfunction and various paroxysmal events (dystonic and plegic attacks). Dystonic and plegic attacks are very disabling and current treatments are disappointing with limited efficacy and poor tolerability. The investigators recently reported the efficacy of high-flow oxygen administration (100% O2 at a flow rate of 12 L/min) as an acute treatment for the dystonic attacks in a 25-year-old patient suffering from AHC. The aim of the study is to assess the effect of high-flow oxygen administration (against placebo) as an acute treatment of dystonic and plegic attacks. The primary outcome will be the proportion of motor attacks stopped 30 minutes after the beginning of motor symptoms over 5 weeks.
The goal of this clinical trial is to study the impact of Dyanavel on co-occuring fatigue in adults with Attention Deficit/Hyperactivity Disorder. The main question it aims to answer is whether Dyanavel XR leads to a statistically significant reduction in fatigue compared to placebo, as measured by the Fatigue Symptom Inventory.
This phase I trial tests the safety, side effects, and best dose of imetelstat in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) that has not responded to previous treatment (refractory) or that has come back after a period of improvement (recurrent). Imetelstat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imetelstat in combination with fludarabine and cytarabine may work better in treating patients with refractory or recurrent AML, MDS, and JMML.
Patients with ruptured liver cancer and bleeding after surgical resection were included according to the criteria of admission, and the patients were divided into experimental and control groups. the primary efficacy end point was RFS, and the secondary end point was the rate of abdominal implant metastases and OS.To analyze the efficacy of HIPEC.
The goal of this clinical trial is to learn about the mechanisms by which minocycline effect blood pressure in individuals with treatment-resistant hypertension. The main questions it aims to answer are: - To what extent does minocycline lower blood pressure and are these effects different across races? - Are such blood pressure effects mediated through changes in gut microbiota, gut leakiness, systemic inflammation, neuroinflammation, or some combination of these? Participants will be randomly assigned to treatment with minocycline or placebo, treated daily for 3 months, to evaluate these questions.
Pulmonary embolism (PE) remains a high mortality and morbidity disease state. The investigators have previously shown that use of a Pulmonary Embolism Response Team (PERT) can improve overall readmission, bleeding, and mortality outcomes. Unfortunately, PERT may still be underutilized from a national standpoint and may not be readily available in underserved areas. The use of artificial intelligence (AI) may help streamline and systematically ensure unbiased mechanism for activation of PERT for discussion of patients with siginficant clot burden and hemodynamic abnormalities. AI algorithms have been FDA approved for use of triage of the PE patient. The institutional PERT program will adapt the use of an AI algorithm for activation as routine care; the efficiency of activation will be compared to our retrospective historical comparison for efficiency and appropriateness of activation. The active phase of the study is designed to further differentiate between patients who are considered to be intermediate-high risk category but yet do not clearly qualify for invasive therapy (catheter-directed therapy, systemic thrombolysis, or invasive hemodynamic support). These patients will undergo walking test to further understand noninvasive hemodynamic compromise and undergo 2:1 randomization to early-invasive strategy versus mtranditional medical therapy.