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Inflammation clinical trials

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NCT ID: NCT05223114 Completed - HIV Infections Clinical Trials

Airway Microbiome and Th17-mediated Inflammation in COPD Among HIV-infected Individuals in a Rural Ugandan Cohort

HLM
Start date: April 1, 2022
Phase:
Study type: Observational

Rationale: COPD is increasing in prevalence among people living with HIV/AIDS (PLWHA) as widespread use of ART has increased longevity in this population. In rural Ugandan ART clinics, we report COPD prevalence of 6.22%. Currently, it's not fully known what drives chronic lung inflammation in PLWHA population despite being virologically suppressed on ART. There is need to explore factors driving chronic airway inflammation among PLWHA. Airway microbiome has been implicated in the pathogenesis of COPD. Preliminary analysis from our study revealed that, specific microbes were significantly enriched in PLWHA with COPD with more lung bacteria impacted by HIV than COPD. These findings suggest that HIV-associated changes in unique airway microbial genera may be driving COPD among PLWHA in our cohort. Currently, we don't know how such genera drive chronic airway inflammation. Study objectives: In this study, we will: (1) establish a relationship between airway microbiome and Th17/Treg cellular phenotypes among HIV-infected individuals with COPD; (2) investigate bacterial-mediated Th17 upregulation of pro-inflammatory and pro-fibrotic genes among HIV individuals with COPD and (3) explore the role of bacterial outer membrane vesicles (OMVs) in mediating microbiome driven Th17 immune responses among HIV individuals. Methods: We will conduct a 2-year case-controlled study, leveraging on the established lung microbiome cohort in rural Nakaseke district of Uganda. We will recruit 80 HIV-infected individuals ≥35 years attending the ART clinic at Nakaseke General Hospital screened for COPD as well as 80 HIV-negative controls ≥35 years attending the pulmonary clinic at Nakaseke General Hospital screened for COPD. In both cases and controls, we will consider 40 stable COPD participants and 40 participants with no COPD. Recruited participants will undergo sputum induction protocol at our newly established negative pressure sputum induction facility at Nakaseke General Hospital following established standard operating procedures. Using induced sputum samples, we will (i) perform 16S sequencing and metagenomics analysis to determine airway bacterial communities, (ii) RNA sequencing and analysis to determine gene expression profiles, mass flow cytometry and analysis to profile immune cells in induced sputum of study participants as well as (iv) ELISA tests to compare OMV levels between participants.

NCT ID: NCT05219890 Withdrawn - Obesity Clinical Trials

Transcriptomics of Mononuclear Cells and Inflammatory Status of Obese Patients Treated With Omega-3 Fatty Acids

Start date: January 16, 2017
Phase: N/A
Study type: Interventional

The main objective is to determine the effect that supplementation with 4.8 g/day of w-3 FA [3.2g eicosapentaenoic acid (EPA) and 1.6 g docosahexaenoic acid (DHA)] have on the inflammatory state of obese patients (BMI ≥ 35.0 kg/m2), at the metabolic, cellular and molecular levels.

NCT ID: NCT05216562 Recruiting - SARS-CoV2 Infection Clinical Trials

Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation In Moderate COVID-19 Patients

EXOMSC-COV19
Start date: July 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

In COVID-19 infection caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is a dysregulation of the immune system response that causes cytokine storm syndrome. SARS-CoV-2 works like a hijacker (hackers), sabotaging communication between cells so that the immune system, like T-cells, kills not only infected cells but also healthy cells. This dysregulation results in hyper-inflammation which cause damage to organs, not just the lungs. This is the cause of the high mortality rate in COVID-19 patients. Exosomes are vesicles with a size of 30-100 nanometers originating from within cells that function to communicate with other cells. Exosomes are transport containers that contain bioactive cargo: such as proteins, genetic material, and various other molecules. These containers move from cells of origin, flowing through blood vessels or other body fluids to target cells. Exosomes penetrate the cell membrane and act on various organelles within the target cell. All cell types can produce exosomes. What differentiates them is the cargo they contain. The exosome produced by mesenchymal stem cells (MSCs) contains bioactive cargo derived from mesenchymal stem cells, such as anti-inflammatory cytokines, growth factors, messengerRNA (mRNA) and microRNA (miRNA). The target cells are immune system cells, infected cells and progenitor cells from infected organs. On target immune cells, the anti-inflammatory cytokines work as immunomodulators to relieve hyper-inflammation. In infected cells, the miRNAs work to prevent viral replication by inhibiting the expression of SARS-CoV-2 virus RNA (viral mRNA silencing and degrading). In lung progenitor cells and other infected organs, the growth factors work to stimulate protein synthesis processes that function for organ regeneration. This study is a multi-center, double-blind, randomized controlled trial (RCT) clinical trial with two arms: one intervention arm, and one control arm. The EXOSOME-MSC will be tested as adjuvant, on top of standard COVID-19 drugs. It will be injected to participants via intravenous route twice, in day-1 and day-7 of 14 days of study participation.

NCT ID: NCT05214872 Completed - Clinical trials for Cardiovascular Diseases

The Impact of Selected Factors on the Cardiovascular System in Chronic Kidney Disease

Start date: March 25, 2016
Phase:
Study type: Observational

Chronic kidney disease (CKD), is characterized by accelerated development of atherosclerosis and advanced remodelling of vessels and the heart. It is associated with many factors, including inflammation, arterial hypertension, hyperlipidemia, hyperhomocysteinemia, secondary hyperparathyroidism, and oxidative stress. Hypertension is one of the most critical risk factors for cardiovascular complications. It leads to the formation of structural changes in the vascular system: it impairs the activity of the endothelium, causes hypertrophy and remodelling of the vascular wall, reduces the susceptibility of the vessels and accelerates the development of atherosclerosis. This study aimed to identify the processes and their representative markers, the concentration of which in the serum may reflect the cardiovascular system status and can predict the increased mortality in HD patients.

NCT ID: NCT05212766 Recruiting - COVID-19 Clinical Trials

Role of the Oral Microbiome & Mucosal Immunity in COVID-19 Disease

MIMSA
Start date: April 7, 2022
Phase:
Study type: Observational

Determining whether in the mouth there are differences between the participant groups in the nature and activity of mucosal innate immunity, in immune responses to SARS-COV2 antigens, or in the oral microbiome

NCT ID: NCT05209867 Completed - Clinical trials for Chronic Inflammation

Single-cell CBD Biomarkers of Inflammation Reduction in People Living With HIV

Start date: May 1, 2022
Phase: Phase 4
Study type: Interventional

People living with HIV (PLWH) are affected by comorbidities appearing to be strongly related to chronic inflammation, a condition characterizing PLWH. The investigators propose to study the effects of CBD on inflammation in PLWH, and establish the molecular role of different immune cells in this process. The investigators plan to use single cell RNA-sequencing (scRNAseq) to isolate CBD-specific cellular phenotypes from five persons with HIV who will provide blood samples before and after taking CBD.

NCT ID: NCT05209776 Recruiting - Clinical trials for Arrhythmogenic Right Ventricular Dysplasia

Local Inflammation in Arrhythmogenic Right Ventricular Cardiomyopathy

LI-ARVC
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

The understanding of ARVC pathophysiology remains incomplete. Several clues indicate that disease progression is mediated through inflammation. The present study aim to document the feasibility of detecting the potential presence of intracardiac local inflammatory components in patients with ARVC.

NCT ID: NCT05208840 Withdrawn - Multiple Sclerosis Clinical Trials

A Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple Sclerosis

LEGATO
Start date: September 15, 2023
Phase: Phase 4
Study type: Interventional

This study will evaluate the evolution of leptomeningeal lesions via leptomeningeal contrast enhancement (LMCE) presence/disappearance after treatment administration in patients with active progressive multiple sclerosis (MS). In addition, this study will investigate if the presence of leptomeningeal inflammation is associated with alterations of B cell repertoire and whether therapy with ocrelizumab will lead to change of B cell repertoire in LMCE-positive patients.

NCT ID: NCT05202782 Recruiting - Clinical trials for High Grade B-Cell Lymphoma, Not Otherwise Specified

Zanubrutinib and CAR T-cell Therapy for the Treatment of Recurrent or Refractory Aggressive B-cell Non-Hodgkin's Lymphoma or Transformed Indolent B-cell Lymphoma

Start date: March 21, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effect of zanubrutinib and CAR T-cell therapy in treating patients with aggressive B-cell non-Hodgkin's lymphoma or transformed indolent B-cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize CAR, a protein on the surface of cancer cells. These CAR-specific T cells may help the body's immune system identify and kill cancer cells. Giving zanubrutinib together with CAR T-cell therapy may kill more cancer cells.

NCT ID: NCT05199012 Completed - Inflammation Clinical Trials

Oral Supplementation With a Black Pepper Extract

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

This study is a randomized, placebo-controlled, double-blind, two-arm trial of N=94 apparently healthy men and women to be recruited at a single investigational center in Northeast Ohio. Subjects will attend three study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work, background baseline diet). Over the next 12 weeks, subjects will attend Visits 2 (baseline) and 3 (week 12), wherein assessments of body weight, waist circumference, urinary ketones, serum glucose, insulin, liver enzymes as well as other biomarkers of metabolic health, quality of life (SF-36 questionnaire), and various visual analog scales (VAS) for appetite, satiety, and cravings will be made.