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Inflammation clinical trials

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NCT ID: NCT04937855 Enrolling by invitation - Inflammation Clinical Trials

The Mechanism of lncRNA NEAT1 in Alleviating Acute Respiratory Distress Syndrome Through miR-27b Regulated Nrf2 Pathway

Start date: July 1, 2021
Phase:
Study type: Observational

The acute respiratory distress syndrome, formerly known as the acute lung injury (ARDS/ALI), is a critical illness with high mortality due to the lack of effective treatment. The pathogenesis of ARDS/ALI has not been fully elucidated. Nuclear factor E2-related factor 2 (Nrf2) plays a key role in regulating lung inflammation and oxidative stress which are closely related to lung injury in ARDS/ALI, but its regulatory mechanism remains unclear. The investigator's provious study shown that microRNA-27b (miR-27b) downregulated Nrf2 to aggravate lung inflammation and histological injury. Furthermore, in lipopolysaccharide (LPS)-induced cell (J774A.1) inflammation model, miR-27b was upregulated while the long non-coding RNA (lncRNA) NEAT1 was downregulated, the putative binding sites of lncRNA NEAT1 and miR-27b were successfully predicted by bioinformatics approach. Thus, the investigators propose that NEAT1 plays as a competing endogenous RNA (ceRNA) to adsorb miR-27b and liberate Nrf2, therefore, to attenuate lung inflammation and related lung injury in ARDS/ALI. This project aims to explore the role of the lncRNA NEAT1/ mir-27b /Nrf2 signal axis in the development and treatment of ARDS/ALI in patients, as well as in LPS-induced ALI animal and cell models by using bioinformatics, molecular biology, histomorphology and clinical phenotype approaches, and to clarify the new mechanism in ARDS/ALI development and to provide new therapeutic targets.

NCT ID: NCT04935450 Recruiting - Clinical trials for COVID-19 Acute Respiratory Distress Syndrome

Pulmonary Inflammation in COVID-19 ARDS

IMPU-COVID
Start date: December 12, 2020
Phase:
Study type: Observational

Patients older than 18 years of age, with COVID-19 related ARDS (C-ARDS) hospitalized in the ICU and invasively mechanically ventilated will be included in the study. This is an observational cohort study. After informed consent by the next of kin, and within the first 72 hours of invasive mechanical ventilation a blood and a Broncho Alveolar Lavage Fluid (BALF) sample will be collected. If the patients remain invasively mechanically ventilated a second and third blood and BALF sample will be collected every 7-10 days.

NCT ID: NCT04933799 Recruiting - COVID-19 Pneumonia Clinical Trials

IRAK 4 Inhibitor (PF-06650833) in Hospitalized Patients With COVID-19 Pneumonia and Exuberant Inflammation.

Start date: January 6, 2021
Phase: Phase 2
Study type: Interventional

The aim of the current clinical study is to evaluate the efficacy and safety of inhibition of Interleukin-1 receptor associated kinase 4 (IRAK4) in ameliorating the proinflammatory state and improving outcomes in severe COVID-19.

NCT ID: NCT04931147 Completed - Inflammation Clinical Trials

A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers

Start date: May 13, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of RXC007.

NCT ID: NCT04928963 Recruiting - Inflammation Clinical Trials

Fighting Immunosenescence and Promoting Immunity by a Fasting-mimicking Diet Elderly.

Start date: September 15, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Immunosenescence is an aging-dependent phenomenon underlying age dependent deterioration in the function of the immune system, characterized by a decline in B and T cells with a relative increase in natural killer (NK) cells. Aging also promotes chronic inflammation accompanied by increased levels of pro-inflammatory cytokines. Both immunosenescence and inflammation contribute to frailty, which is a geriatric syndrome characterized by age-related deterioration in multiple physiological systems resulting in greater vulnerability to stressors and increased risk of poor outcomes including longer hospital stays, postoperative complications, poor responses to vaccination, functional decline, and death. Although pharmacological interventions could be developed to address immunosenescence, inflammation and frailty, a dietary intervention that does not cause weight or muscle loss may be a preferable option, particularly if it is periodic in nature and it only needs to be adopted for a few weeks per year. Hypothesis: We will test the hypothesis that a newly formulated and relatively high calorie fasting mimicking diet (FMD) to be administered to subjects age 65-80 once a month for 5 days for two to six cycles can partially reverse immunosenescence and inflammation, thus contributing to the reduction of frailty. Aims: This proposal is divided into 2 main tasks: Task 1: We will determine whether FMD cycles in mice: a) prevent frailty syndrome onset and symptoms B) delay or reverse age-related immunosenescence and inflammaging, C) improve the functionality of bone marrow cells, D) enhances the response to flu vaccination. Task 2: A )We will develop a special relatively high calorie FMD medical food for testing in humans, B) We will test the safety and efficacy of the FMD medical food in an aged and frail individuals (65-80 yr) for 2-5 day cycles preceding their annual influenza vaccination. Expected results: In mice, we expect that the FMD diet will reduce the clinical signs of frailty during aging, and in particular increase immune system influenza vaccine response by preventing immunesenescence. We expect that the FMD will reduce phosphorylation of mTOR and of its downstream targets, and induce autophagy and apoptosis in WBCs. These effects are anticipated to remove damaged cells and promote the activation of hematopoietic stem cells and the generation of new WBCs. We also expect that the transient increase in corticosteroids and removal of damage immune cells will be accompanied by a decrease in systemic inflammation. Increased performance on rotarod and other measures of frailty is also anticipated. In humans, we expect that the FMD will be well tolerated by the pre-frail elderly without major adverse events and that it will be possible to achieve high compliance to this diet. We also anticipate that elderly undergoing the FMD protocol followed by 30 days of a normal diet plus supplements will exhibit better functional status and better response to the flu vaccine as compared to patients from the control arm. An improvement in handgrip strength and in lean body mass, as detected by BIA, is also expected, at least in a fraction of the patients from the intervention arm. Impact: Frailty is a geriatric syndrome characterized by age-related deterioration in multiple physiological systems and homeostatic mechanisms, resulting in greater vulnerability to stressors and increased risk of poor outcomes including longer hospital stays, postoperative complications, poor responses to vaccination, functional decline, and death. Thus, the identification of a dietary strategy, potentially to be applied for only 10 days a year but able to rejuvenate the immune profile and function while reducing systemic inflammation could have a major impact on both healthspan and health-related expenses. Because older individuals are often taking multiple drugs, the dietary intervention being investigated here would also reduce the potential toxicity of an additional pharmacological intervention.

NCT ID: NCT04923555 Completed - Metabolic Syndrome Clinical Trials

Analysis of the Postprandial Effects of a Vegetable Protein Mixture Rich in Arginine, Cysteine and Leucine on Endothelial Dysfunction and Inflammation at Low Noise in Elderly People With Cardiometabolic Risk

P-PROBS CM
Start date: November 9, 2021
Phase: N/A
Study type: Interventional

By 2050, the expanding world population will consume two-thirds more animal protein than it consumes today. The increase in chronic diseases associated with the generalization of these consumption patterns tend to understand the place of meat in our diets. All these elements participate to the reduction of animal proteins in favor of vegetable proteins in our food. The elderly are particularly affected by malnutrition, the prevalence of protein-energy malnutrition increasing with age and promoting the onset of morbidities. Without care, it leads to the worsening of physiological phenomena linked to aging such as loss of muscle functionality (sarcopenia) or reduction in bone density (osteoporosis) and increases the risk of falls - the main cause of dependence. However, in France, protein consumption declines significantly with age, even though requirements appear to be greater for the elderly. It is therefore a major challenge for our societies to ensure that the aging of the population and the increase in life expectancy are not synonymous with a reduction in the physical and mental capacities of individuals. Thus, it is essential to ensure that the recommendations for reducing the intake of animal proteins in favor of vegetable proteins can be applied without risk to aging populations, in particular on the human body cardiovascular risk of these populations.

NCT ID: NCT04914884 Active, not recruiting - Clinical trials for Intraocular Inflammation

Intraocular Fluid Detection in Endophthalmitis

Start date: June 1, 2021
Phase:
Study type: Observational

Endophthalmitis is also called vitreous inflammation. Broadly speaking, it refers to all kinds of serious intraocular inflammation, such as vitreitis, anterior chamber empyema and eye pain caused by intraocular infection, intraocular foreign body, tumor necrosis, severe non infectious uveitis, lens cortex allergy, etc. Clinically, it generally refers to infectious endophthalmitis caused by bacteria, fungi or parasites. According to the different ways of infection, it can be divided into exogenous endophthalmitis and endogenous endophthalmitis. Exogenous endophthalmitis is more common. When inflammation involves sclera or extraocular orbital tissue, it is called "panophthalmia". Endophthalmitis is a kind of serious intraocular inflammation which can lead to the loss of visual function. Early diagnosis and treatment is the key. Studies have found that the changes of cytokines in aqueous humor are helpful for the diagnosis of endophthalmitis. Okhrvai et al. Also pointed out that the application of PCR can reduce the diagnosis time of endophthalmitis. This study mainly verified the use of molecular biology technology to detect the changes of VCAM, ICAM-1 and other cytokines, bacteria, viruses, fungi, Toxoplasma gondii IgG in patients' intraocular fluid, including aqueous humor and vitreous humor, so as to timely judge the etiology and progress of endophthalmitis, and provide reference for diagnosis and treatment.

NCT ID: NCT04914312 Completed - Inflammation Clinical Trials

Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

The purpose of this trial is to determine the effect of maqui extract plus omega-3 fatty acids compared to a placebo for reducing inflammatory cytokine levels in older, obese adults.

NCT ID: NCT04912921 Completed - COVID19 Clinical Trials

Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19

Start date: October 20, 2020
Phase: N/A
Study type: Interventional

Two randomized controlled trials will be conducted to examine the effect of a food supplement on proinflammatory cytokines and biomarkers in an adult population recently diagnosed with COVID-19 who are asymptomatic or experiencing only mild symptoms. The supplement, palmitoylethanolamide (PEA), is marketed under the trademarked product with increased bioavailability and format versatility: Levagen+™ (Gencor Pacific Limited, Irvine, CA). The supplement curcumin is marketed under the trademarked product with increased bioavailability: HydroCurc (Gencor Pacific Limited, Irvine, CA)

NCT ID: NCT04910971 Recruiting - Inflammation Clinical Trials

Quantification of Binding and Neutralizing Antibody Levels in COVID-19 Vaccinated Health Care Workers Over 1 Year

Start date: January 31, 2021
Phase:
Study type: Observational

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic presents a great challenge to global health. The first case was identified in December 2019 in Wuhan, China and since has infected nearly 100 million people and claimed almost 2 million lives worldwide. In response, the medical community and scientists have worked hard to develop effective therapies and guidelines to treat a wide range of symptoms including the use of the antiviral drug remdesivir, convalescent plasma, antibiotics, steroids, and anticoagulant therapy. To prevent the spread of the disease, multiple vaccines based on mRNA and DNA technologies that include inactivated viral components have been developed and millions of doses are currently being administered worldwide. Early analysis of data from the phase III Pfizer/BioNTech and Moderna vaccine trials suggested the vaccine was more than 90% effective in preventing the illness with a good safety profile (Polack et al., 2020). However, there are still many unknowns regarding the long-term safety of these newer vaccine technologies and the level and duration of immunogenicity. SARS-CoV-2 infection results in seroconversion and production of anti-SARS-CoV-2 antibodies. The antibodies may suppress viral replication through neutralization but might also participate in COVID-19 pathogenesis through a process termed antibody-dependent enhancement (Lu et al., 2020). Rapid progress has been made in the research of antibody response and therapy in COVID-19 patients, including characterization of the clinical features of antibody responses in different populations infected by SARS-CoV-2, treatment of COVID-19 patients with convalescent plasma and intravenous immunoglobin products, isolation and characterization of a large panel of monoclonal neutralizing antibodies and early clinical testing, as well as clinical results from several COVID-19 vaccine candidates. In this study, we plan to assess the effic of both vaccines on the healthcare workers. As healthcare workers begin to receive their first vaccination dosage, we will start looking for traces of antibodies within the blood and saliva. The data provided will help us determine the efficacy of the vaccine over a period of 1 year, identify any difference in efficacy amongst different populations (gender, age, and ethnicities) differences among vaccine types, demographics and follow-up on any potential side effects. We will collaborate with Nirmidas Biotech Inc. based in Palto Alto, California, a Stanford University spinoff on this project. Nirmidas Biotech. Inc is a young diagnostic company that have received several FDA EUA tests for COVID-19. We will perform IgG/IgM antibody detection by the NIRMIDAS MidaSpot™ COVID-19 Antibody Combo Detection Kit approved by FDA EUA for POC testing in our hospital site for qualitative antibody testing. We will then send dry blood spot and saliva to Nirmidas for the pGOLD™ COVID-19 High Accuracy IgG/IgM Assay to quantify antibody levels and avidity, both of which are important to immunity. The pGOLD assay is a novel nanotechnology assay platform capable of quantifying antibody levels and binding affinity to viruses. We collaborated recently with Nirmidas on this platform and published a joint paper in Nature Biomedical Engineering on COVID-19 Ab pGOLD assay (Liu et al., 2020). It is also capable of detecting antibodies in saliva samples and could offer a non-invasive approach to assessing antibody response for vaccination.