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Filter by:This is a Phase I open-label interventional study which will test the efficacy of ResCure™ in the treatment of patients with COVID-19 infection.
The purpose of this study is to determine the safety, tolerability, and recommended phase 2 dose (RP2D) of TAK-573 when used with dexamethasone and in combination with bortezomib, pomalidomide, or cyclophosphamide, in participants with RRMM.
This is a multicenter, cluster randomized controlled trial to assess the effects of an optimized intraoperative fluid and blood management strategy on postoperative complications.
This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy.
The purpose of the COVIDNOCHE trial (HFNO versus CPAP Helmet Evaluation in COVID-19 Pneumonia) is to evaluate the comparative effectiveness of standard care non-invasive respiratory support (helmet CPAP versus HFNO) for acute hypoxemic respiratory failure from COVID-19 pneumonia on ventilator-free days (primary outcome) and other clinical outcomes measured up to 90 days.
COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2. COVID-19 causes life threatening complications known as Cytokine Release Syndrome or Cytokine Storm and Acute Respiratory Distress Syndrome. These complications are the main causes of death in this global pandemic. Over 1000 clinical trials are on-going worldwide to diagnose, treat, and improve the aggressive clinical course of COVID-19. The investigators propose the first, and so far, only gene therapy solution that has the potential to address this urgent unmet medical need. Rationale 1. There are striking similarities between the damaged lung environment of COVID-19 induced ARDS and the tumor microenvironment (exposed collagen from tissue destruction by invading tumor or by the virus-induced immune response, and presence of activated proliferative cells (cancer cells and tumor associated fibroblasts or activated T cells, macrophages and pulmonary fibroblasts in COVID-19); 2. DeltaRex-G is a disease-seeking retrovector encoding a cytocidal dominant negative human cyclin G1 as genetic payload). When injected intravenously, the DeltaRex-G nanoparticles has a navigational system that targets exposed collagenous proteins (XC proteins) in injured tissues (e.g. inflamed lung, kidney, etc.), thus increasing the effective drug concentration at the sites of injury, in the vicinity of activated/proliferative T cells evoked by COVID-19. Our hypothesis is that DeltaRex-G then enters the rapidly dividing T cells and kills them by arresting the G1cell division cycle, hence, reducing cytokine release and ARDS; 3. Intravenous DeltaRex-G has minimal systemic toxicity due to its navigational system (targeting properties) that limits the biodistribution of DeltaRex-G only to areas of injury where exposed collagenous (XC) proteins are abnormally found; and 4. DeltaRex-G is currently available in FDA approved "Right to Try" or Expanded Access Program for Stage 4 cancers for an intermediate size population. To gain this approval, FDA requires DeltaRex-G to have demonstrated safety and efficacy in early clinical trials.
The purpose is to investigate the COVID-19 prevalence, associated morbidity and long-term cognitive deficits in consecutive patients presenting with acute neurological symptoms
Individuals with cancer causing an intestinal or stomach obstruction often require gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. This is often achieved by a nasogastric (NG) tube, although prolonged NG tube use can lead to unwanted side effects like ulcers, bleeding, and they are generally uncomfortable. Gastric drainage through the use of a percutaneously placed endoscopic gastrostomy (PEG) tube has been used in people with cancer since the 1980s. This allows relief of symptoms of malignant bowel obstruction though venting of stomach contents. Decompressive PEG tubes are routinely used in individuals with malignant obstruction, although these tubes tend to get clogged from food blocking the tube. The AspireAssist is a weight loss device that allows participants to remove a large amount of the food in their stomachs after each meal to help them to lose weight via an aspiration device attached to the abdominal portion of the tube which allows instillation of water into the stomach, followed by aspiration of the gastric contents into a receptacle or the toilet. The device is placed endoscopically in an identical fashion to a standard PEG tube. Although most commonly used for weight loss, the device is FDA cleared to be used as a venting tube as well. The purpose of this study is to determine if the AspireAssist provides an improved quality of life when compared with a standard venting gastrostomy tube for participants with malignant bowel obstructions.
Background: A small subset of the patient population is responsible for a significant proportion of healthcare expenditures. These patients are cared for in academic medical centers by internal medicine residents however there has been no research to date about the education or the management of patients with complex multimorbidity in the outpatient setting. Objective: To evaluate the impact of the High Risk Outpatient Intern-led Care (HeROIC) Clinic on internal medicine interns' perceived ability to manage complex outpatients as well as pre and post intervention total patient healthcare cost. Methods: The investigators created the HeROIC outpatient clinic environment to comprise longer visit time slots, "bedside" presentations, and team-based care (one intern primary care provider, one secondary intern, and one longitudinal attending). All non-preliminary interns based at one primary care site participated in the intervention while interns at a second site continued to practice in the usual outpatient clinic environment. The interns in the HeROIC clinic arm assumed the roles of primary care providers for 34 complex patients in total. The primary outcome was the perceived confidence in the management of complex outpatients as assessed by a survey. Secondary outcomes included perceptions about the ability to provide high-quality outpatient and evidence-based outpatient care, as well as statewide pre-post patient healthcare cost data.
This phase I trial studies the side effects and best dose of CB-5339 in treating patients with solid tumors that has spread to other places in the body (advanced) or lymphomas. CB-5339 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.