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Inflammation clinical trials

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NCT ID: NCT05864352 Completed - Inflammation Clinical Trials

The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health

Start date: September 22, 2021
Phase:
Study type: Observational

This proposal will quantify dietary exposure of a nano- food additive in the U.S. food supply, and determine its impact on the human gut microbiome, gut inflammation, permeability and oxidative stress. Titanium dioxide (TiO2, or E171 food grade additive) is used in processed foods, with thousands of tons produced annually and an expected increase >8.9% from 2016 to 2025. Preclinical models demonstrate >99% of consumed TiO2 is retained within the intestinal lumen and excreted in the feces. In animal models, dietary TiO2 causes shifts in the gut microbiome, decreases acetate production, increases biofilm formation, and causes profound disruption of gut homeostasis and intestinal tight junctions, due to the production of reactive oxygen species and increased inflammation. However, the relation between chronic TiO2 intake and human gut homeostasis has yet to be elucidated. France issued an executive order to ban food grade TiO2 use after January 1st 2020, over serious safety concerns. Since then, multiple European civil societies have jointly called for an executive order to ban TiO2 across the EU. Typical TiO2 intake among U.S. adults remains to be documented, and there are no known studies that estimate dietary exposure of TiO2 using a whole foods approach. Therefore, the overarching goals of this project are to: 1) measure dietary TiO2 exposure in a sample of U.S. adults, using dietary recalls and fecal TiO2 content; 2) determine how fecal TiO2 content is related to gut dysbiosis, metatranscriptomics, intestinal inflammation, permeability and oxidative stress.

NCT ID: NCT05861206 Completed - Inflammation Clinical Trials

Efficacy of Green and White Tea Extract Mouthwashes in the Management of Plaque-induced Gingivitis: A Clinical and Biochemical Study

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Background and objective: Tea is the second most consumed drink in the world after water. Gingivitis is among the most common infectious diseases. In this clinical study, Chlorhexidine Gluconate (CHX) was chosen as the positive control group and the clinical and biochemical efficacy of mouthwashes with green tea, white tea and essential oil (EO) as the active ingredients were aimed to be examined comprehensively. Methods: 112 participants with gingivitis were randomly assigned to 4 different groups that different mouthwashes were used for 4 weeks. CHX-MW group (0.12% CHX, as a positive control group), EO-MW group (Listerine), GT-MW group (5% Green tea), and WT-MW group (5% White tea). The effects of the mouthwashes on plaque, inflammation, and dental staining were evaluated by indexed scores at the beginning and the end of the 4th week. In addition, markers related to gingival inflammation (IL-1beta, MMP-8) and oxidative stress (TOS, TAS, OSI (TOS/TAS)) were evaluated on samples from the gingival crevicular fluid.

NCT ID: NCT05860400 Recruiting - Clinical trials for Coronary Artery Disease

Efficacy and Safety of Comprehensive Treatment in Patients With IR-CAD: a Self-controlled Cohort Study

Start date: May 17, 2023
Phase:
Study type: Observational [Patient Registry]

This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.

NCT ID: NCT05857202 Recruiting - Quality of Life Clinical Trials

Oxidative Stress and Inflammation Biomarkers in Surgically Treated Patients With Laryngeal Cancer

Start date: September 1, 2022
Phase:
Study type: Observational

A experimental interventional prospective study will include patients with squamocellular carcinoma of the larynx surgically treated at the tertiary referral center. Clinical and demographic characteristics of the patients would be noted. The visual analog scale (VAS), Brief Pain Inventory questionnaire, Diagnosing Neuropathic Pain 4 (DN4) and Pain Detect Questionnaire were used for pain assessment. Questionnaire Quality of Life in Head and Neck Cancer Patients (QLQ - H&N35) was used to assess the quality of life in patients with surgically treated laryngeal carcinoma. The type and consumption of analgesics used after surgery was monitored. The analgesics were used according to WHO Ladder. Blood samples ware taken from the patients for the analysis of oxidative stress parameters and inflammation parameters before the operative treatment and after the operative treatment (1-2 postoperative day and 9-10 postoperative day). The concentrations of interleukin 1 (IL-1) and 6 (IL-6), glutathione peroxidase 1 (GPX1), superoxide dismutase 1 (SOD1) and malondialdehyde (MDA) in the serum were determined. The aim of the study will be to assess concentrations of inflammatory biomarkers (IL-1, IL-6) and oxidative stress factors (MDA, SOD, GPKS1) in postoperative course in surgically treated patients with laryngeal carcinoma and in possible complication occurrence. Also, their correlation to type and dosage of used analgesics, to pain assessment questionnaire scores and QOL questionnaire scores in surgically treated patients with laryngeal carcinoma will be assessed.

NCT ID: NCT05854563 Recruiting - Lung Cancer Clinical Trials

Cough Capture as a Portal Into the Lung

CC1
Start date: March 28, 2023
Phase:
Study type: Observational

Background: The lung is a privileged organ; blood does not reflect most lung processes well, if at all. Therefore, for population scale diagnostics, the investigator team is developing non-invasive portals to the lung, for eventual early detection/risk assessment and diagnostic purposes. However, large macromolecules are not likely suspended nor readily detected in the breath. In particular, genomic DNA in the breath condensate (EBC) is very sparse, and where present, generally highly fragmented, not readily amenable to sequencing based assessments of DNA somatic mutation burden or distribution. Because gDNA (and protein) is challenging to obtain non-invasively from EBC, the study team considered alternative surrogate lower airway specimens. Cough capture is rarely done, and the investigator team is in the process of optimizing its collection. Importantly, the team will be evaluating how much of coughed material is from saliva contamination. Additionally, analyzing material that is target captured by capturing deep lung extracellular vesicles (EVs) using immobilized CCSP/SFTPC antibodies targeting EVs from distal bronchiole Club and alveolar type 2 cells could circumvent the mouth contamination problem, leaving a non-invasive portal to the deep lung suitable for large molecules, and in turn suitable for myriad epidemiologic and clinical applications. Proposal: The investigator team proposes (Aim 1) to pursue optimizing cough collection, and testing the efficacy and practicality of partitioning cough specimen for deep-lung specific extra-cellular vesicles (EVs). This cough specimen will be compared to that from invasively collected deep lung samples BAL/bronchial brushings, and to the potential contaminating mouthrinse, all from the same individuals. (Aim 2) The study team initially proposes to examine these cough specimens for somatic mutations by SMM bulk sequencing for single nucleotide variation, developed in the Vijg/Maslov labs. Finally, the investigator team will (Aim 3) test all airway specimens (cough, mouthwash and BAL) for lung surrogacy of cough, using proteins known to be specific for lung, as opposed to oral cavity/saliva, in the Sidoli/proteomics core. Impact: The investigator team envisions that the translational impact of non-invasively obtained DNA or protein markers could allow for more rapid acute clinical diagnoses, and facilitate precision prevention and/or early detection of many acute and chronic respiratory disorders, including lung cancer, asthma and COPD, acute and chronic infectious diseases, and indeed systemic disorders of inflammation and metabolism.

NCT ID: NCT05852288 Not yet recruiting - Clinical trials for Carpal Tunnel Syndrome

Role of Inflammation in Carpal Tunnel Syndrome

Start date: May 15, 2023
Phase:
Study type: Observational

This study aims to investigate the role of inflammation in carpal tunnel syndrome (CTS) using a prospective cohort study design. The study will involve a sample of at least 50 individuals with CTS who will undergo a comprehensive clinical and biochemical evaluation to assess the role of inflammation in CTS. The primary outcome measures include inflammatory markers, such as C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), as well as clinical measures of CTS severity. Data will be analyzed using regression analysis to determine the relationship between inflammation and CTS. The study is expected to provide information on the role of inflammation in CTS and inform the choice of drug and concentration for transdermal drug administration.

NCT ID: NCT05850247 Not yet recruiting - CAROTID STENOSIS Clinical Trials

Plaque and Brain Inflammation in Symptomatic Carotid Stenosis: Role of the Ficolin-2

STATEMENT
Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

Carotid artery stenosis is observed in about 3% of ≥ 60 years subjects and accounts for around 10-20% of all ischemic strokes. Beyond the degree of stenosis, plaque composition affects the risk of ischemic stroke. Identification of patients with vulnerable plaques at higher risk of stroke who might benefit from carotid revascularization is crucial. A growing body of evidence suggests that the lectin pathway of the complement system, and especially the ficolin-2, is involved in atherosclerosis. It has been hypothesized that circulating levels of ficolin-2 increase during chronic inflammatory conditions (i.e. growing atherosclerotic plaque) whereas they fall during sub-acute or acute inflammatory conditions (i.e. plaque rupture and acute ischemic stroke) because of consumption (binding to targets). Therefore, ficolin-2 has been proposed as a biomarker informing on the specific state of the plaque. However, in acute ischemic stroke due to carotid stenosis, both plaque rupture and stroke injury contribute to lectin pathway activation, thus affecting circulating levels of ficolin-2. Until now, the relative contribution of plaque and brain inflammation on circulating levels of ficolin-2 has not been documented. In the present study the investigators aim to assess the association between circulating levels of ficolin-2 and carotid and brain inflammation on [18F]DPA-714 positron emission tomography (PET)/MRI in patients with transient ischemic attack or acute ischemic stroke due to carotid stenosis. For that purpose, the investigators intend to include 30 patients with transient ischemic attack or acute ischemic stroke due to ≥ 50%. carotid stenosis. Each patient will have a measure of plasmatic level of ficolin-2 as well a [18F]DPA-714 PET/MRI to quantify the fixation of the radiotracer on carotid and brain.

NCT ID: NCT05849038 Recruiting - Depression Clinical Trials

Inflammation and Depression in People With HIV

Start date: December 11, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this 10-week, double-blind, placebo-controlled study is to determine whether inflammation impacts reward and motor neural circuitry to contribute to depressive symptoms like anhedonia and psychomotor slowing in people with Human Immunodeficiency Virus (HIV) and depression. Sixty male and female patients with HIV who have depression, anhedonia and high inflammation and are stable on effective treatment for their HIV will be randomized to receive either the anti-inflammatory drug baricitinib or a placebo for 10 weeks. Participants will complete lab tests, medical and psychiatric assessments, neurocognitive testing, functional MRI (fMRI) scans, and optional spinal taps as part of the study. The total length of participation is about 5 months.

NCT ID: NCT05847452 Recruiting - Asthma Clinical Trials

Beyond the Eosinophil: Understanding the Impact of Eosinophil Depletion on T2 Inflammation. (BEUTI)

BEUTI
Start date: May 22, 2023
Phase:
Study type: Observational

Benralizumab is a relatively new treatment that is approved by NICE (National Institute for Health and Care Excellence, https://www.nice.org.uk/) for patients with severe asthma who have ongoing eosinophilic inflammation that remains poorly controlled despite high dose inhaled glucocorticosteroid medication. Eosinophils are a type of white blood cell that are linked to allergy and inflammation and are raised in people with severe asthma. Severe asthma is associated with a type-2 (T2) inflammation phenotype characterised by increased T2 cytokines (IL-13, IL-4, IL-5). Increased levels of eosinophils can cause inflammation in the lungs, increasing the risk of asthma attacks. The standard treatment for asthma involves taking inhaled glucocorticosteroid medication which primarily work by suppressing eosinophilic inflammation in the lungs. Benralizumab is a monoclonal antibody that targets a receptor on the surface of eosinophils called interleukin-5 receptor-α (IL-5Rα) leading to the rapid death of these cells and consequently a reduction in airways inflammation. In clinical trials, benralizumab has been shown to reduce both symptoms and the number of asthma attacks suffered by those with severe eosinophilic asthma. However, it remains unclear whether this clinical efficacy relates purely to the removal of the eosinophil, or additionally to the impact of this on other parts of the immune system. The BEUTI study will examine the structure and function of airway cells in patients with severe eosinophilic asthma. Particularly how the immune function of these cells changes with treatment and whether benralizumab leads to a reduction in T2 mediators and/or activation in airway cells. The aim is to take samples of cells from the airways during a bronchoscopy (a camera test looking into the lungs) before starting benralizumab and after 12 weeks of treatment. These investigations will allow us to better understand how benralizumab affects the cells within the airways and the pathways involved.

NCT ID: NCT05843526 Completed - Dental Implants Clinical Trials

Influence of Implant Component Materials on Peri-implant Soft Tissue Horst Response.

PISTI
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study was to characterize the host-related response of peri-implant soft tissue induced by 3 different materials: titanium, resin and PEEK (polyetheretherketone) on man. The primary endpoint is to asses the histological data available: Histological analyses are carried out with immunohistology (CD68, CD3, CD20, macrophages), non decalcified histology to appreciate the structure of the peri implant soft tissues (Sulcus depth, junctional epithelium, connective tissue adhesion). Moreover: scanning electronic microscope (SEM) of the experimental abutment is performed to juge the cell adhesion on the abutment surface. The secondary endpoint is to assess clinical data, radiological bone remodeling regarding the different material. The hypothesis is that resin abutment lead to more inflammation than PEEK or titanium.