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PROTOCOL SUMMARY:
Long title: Proposed use of TPE (therapeutic plasma exchange), to Limit Coronavirus Associated Complications: An Open label, Phase 2 Study
Clinical Phase: Two arms, Phase 2 Open Label
Conducted by: Department of Pulmonology and Critical Care; Pak Emirates Military Hospital.
Sample
Surgical resection is the main modality of treatment for many solid tumors. Despite successful tumor resection, some patients develop local recurrence or metastasis, causing morbidities and mortality. In recent years, there is growing interest in the pathophysiology of recurrence or metastasis. It
Acute respiratory distress syndrome (ARDS) which is a major cause of morbidity and mortality in the intensive care unit, is characterized by decreased lung volume, decreased lung compliance, increased pulmonary vascular resistance and pulmonary hypertension, which ultimately lead to right
5. INTRODUCTION
5.1 Executive Summary RLF-100 (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP), a ubiquitous, naturally synthesized human peptide with extensively documented anti-inflammatory, anti-cytokine cascade properties. It has been granted FDA Fast Track Designation
INTRODUCTION
1.1 BACKGROUND
Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection is a new rapidly spreading infectious disease with no proven treatment options. The virus causes a spectrum of disease ranging from mild coryzal symptoms to severe respiratory compromise requiring
Acutely ill adult COVID-19 patients with hypoxaemic respiratory failure admitted to the intensive care unit (ICU) are at risk of life-threatening hypoxia, and are provided supplementary oxygen. Liberal use of supplementary oxygen may increase the number of serious adverse events including death.
This Phase 2 study is designed as a proof of concept study and will randomize 2:1 approximately 60 patients with COVID-19 associated acute hypoxemia: of which 40 patients will receive sargramostim plus standard of care, and 20 patients who will receive standard of care alone. The aim of the study is
There are clinical data to support the observation that hospitalized acutely ill medical patients with severe viral pneumonitis/Acute Respiratory Distress Syndrome (ARDS), such as those with influenza H1N1 infection, have an over 23-fold increased risk for venous thromboembolism (VTE) - especially
Acute kidney injury (AKI) occurs in almost 50% of patients treated in intensive care units. AKI mainly occurs after sepsis, acute ischemia, nephrotoxicity or hypoxia and leads to severe damage of the kidney and to an increased risk of mortality. The diagnosis of AKI is currently based on creatinine,
INTRODUCTION After the first cases identified in Wuhan city (China) on December 2019, the novel coronavirus designated SARS-CoV-2 has caused a global epidemic of respiratory illness named COVID-191. To date, more than, 3,000,000 cases have been reported worldwide, including more than 300,000
Background
COVID-19 has shown a lower case-fatality rate compared to other major viral outbreaks in contemporary history, including severe acute respiratory syndrome (SARS) of 2002-2003. However, the relative susceptibility to symptomatic infection and the case fatality risk increase substantially
The purpose of this study is to assess the safety, tolerability, potential efficacy of high dose intravenous vitamin C (HDIVC) therapy for patients with COVID-19 and decreased oxygenation. COVID-19 is a rapidly evolving pandemic with numerous prediction models suggesting potential shortages in
In December 2019, a group of patients with the acute respiratory disease was detected in Wuhan, Hubei Province of China. A month later, a new beta-coronavirus was identified as the cause of the 2019 coronavirus infection. Despite China's efforts to contain the disease, it spread rapidly outside the
Recent information on patients at risk for developing serious complications, including death, in the setting of COVID-19, indicate that those with cardiometabolic disease (hypertension, type 2 diabetes, atherosclerotic cardiovascular disease, heart failure, and/or kidney disease at baseline) are at
The study will be divided into two phases, each with different variables to evaluate, as described below:
The primary objective of the first phase (proof-of-concept) will be to evaluate the effect of pyridostigmine on the serum level of interleukin (IL)-6 as an indicator of severe inflammation, as