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Inflammation clinical trials

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NCT ID: NCT04943783 Recruiting - Clinical trials for Inflammation Vascular

Atorvastatin in the TREATment of Intracranial Unruptured VertebroBasilar Dissecting Aneurysms

ATREAT-VBD
Start date: July 1, 2021
Phase: N/A
Study type: Interventional

This study was designed to whether there is a measurable reduction in inflammation in walls of unruptured vertebrobasilar dissecting aneurysms with atorvastatin.

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: 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: 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 MidaSpotā„¢ 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 pGOLDā„¢ 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.

NCT ID: NCT04897620 Recruiting - Pain, Chronic Clinical Trials

COMPARISON OF SYSTEMIC INFLAMMATION-RELATED HEMATOLOGICAL PARAMETERS IN ACUTE AND CHRONIC LOW BACK PAIN

Start date: May 5, 2021
Phase:
Study type: Observational

The aim of the study is to compare the neutrophils to lymphocytes ratio (NLR), platelets to lymphocytes ratio (PLR), eosinophils to lymphocytes ratio (ELR), red blood cell distribution width (RDW), mean platelet volume (MPV), systemic immune inflammation index (SII), erythrocyte sedimentation rate (ESR) and C reactive protein (CRP) which are the hematological parameters associated with systemic inflammation in acute and subacute/chronic low back pain. Secondary purpose; evaluation of the prognostic roles of hematological parameters associated with systemic inflammation in low back pain in predicting chronicity.This study is a retrospective case-control study. The data of patients who applied to the emergency department with the complaint of acute (less than 4 weeks) low back pain or to the Physical Medicine and Rehabilitation outpatient clinic with the complaint of subacute (lasting 4-12 weeks) or chronic (longer than 12 weeks) non-specific low back pain in the last 3 years will be scanned. The data of patients who applied with complaints other than medical conditions known to be associated with painful conditions and/or inflammatory response will be screened as a control group. The data of patients between the ages of 18-65 will be included in the study. In conclusion, the data of 150 patients who presented with acute non-specific low back pain, 150 patients who presented with subacute/chronic non-specific low back pain and 150 participants as the control group will be included in the study for use in analysis. Participants' age, gender, duration of low back pain (days), if evaluated, conditions associated with low back pain in cases with subacute/chronic pain, ESR, CRP, RDW, MPV, neutrophil count, lymphocyte count, eosinophil count and platelet count in blood tests at admission examinations will be recorded. NLR will be calculated by dividing the number of neutrophils by the number of lymphocytes, PLR by dividing the number of platelets by the number of lymphocytes, ELR by dividing the number of eosinophils by the number of lymphocytes, and SII by the formula "platelet numberxneutrophil number/lymphocyte number".

NCT ID: NCT04888923 Recruiting - Inflammation Clinical Trials

Natural History of the Human Biological Response to Environmental Exposure and Injury

Start date: November 16, 2021
Phase:
Study type: Observational

Background: Environmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies. Objective: To identify and understand how environmental exposures contribute to human disease. Eligibility: Healthy adults ages 18 and older Design: Participants will be screened with questions about their health history, demographics, and medicines they take. Participants may give blood, hair, stool, saliva, and/or urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath. Participants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup. Participants may have their nasal passages brushed, scraped, or washed. Participants may give cheek cell samples. They will swish mouthwash and spit it into a cup. Participants who produce sperm may give samples. Participants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung. Participants may have a pelvic or transvaginal ultrasound. They may have lung function tests. Participants may collect household dust, urine, or stool at home. Participants will complete surveys about their health, diet, and exposures. Participation will last for one or more study visits. Participants may be contacted in the future to take part in other studies.

NCT ID: NCT04887623 Recruiting - Clinical trials for COVID-19 Respiratory Infection

Dynamics of Markers of Infection and Inflammation in Hospitalized Coronavirus Disease 2019 (COVID-19) Patients

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

Patients requiring admission to the hospital due to a moderate and severe COVID-19 infection may differ in their ability to respond to viral infection and to eliminate viral load. Several comorbidities and interventions like antivirotic or antiinflammatory treatment may also modify expected patients response and decrease of viral load. In this observational study, evolution of selected inflammatory markers, indicators of severity of infection and patient characteristics will be followed and recorded in hospitalized patients with COVID-19.

NCT ID: NCT04886713 Recruiting - Obesity Clinical Trials

Adipose Tissue Inflammation in HFpEF

SLIM-HFpEF
Start date: November 1, 2019
Phase:
Study type: Observational

To evaluate the role of adipose tissue inflammation in patients with heart failure with preserved ejection fraction (HFpEF). Patients undergoing coronary artery bypass grafting with HFpEF and without heart failure will be included in this prospective study. Epicardial, paracardial, paraaortic/paravascular, subcutaneous adipose tissue samples as well as myocardial tissue will be harvested during cardiac surgery. Inflammatory patterns of these tissues and their relation to circulating markers will be investigated.

NCT ID: NCT04862468 Recruiting - Clinical trials for Thrombosis, Deep Vein

Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT

DEXTERITY-AFP
Start date: October 29, 2021
Phase: Phase 2
Study type: Interventional

This is a study of a medical procedure that utilizes a commercially available catheter (the Bullfrog® Micro-Infusion Device) to locally deliver a commercially available anti-inflammatory drug (dexamethasone sodium phosphate injection) around the deep veins after DVT recanalization, where DVT symptoms were present for up to 14 days prior to recanalization. The goal of the study is to see if local anti-inflammation helps prevent re-thrombosis of the blood vessel and improvement in symptoms for up to 24 months after the initial DVT recanalization procedure.