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Systemic Inflammatory Response clinical trials

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NCT ID: NCT06136793 Not yet recruiting - Diabetes Mellitus Clinical Trials

HomeStyles-Adults of Chinese Heritage

Start date: June 2024
Phase: N/A
Study type: Interventional

Individuals of Chinese heritage are the largest and fastest growing segment of the US Asian population. US Chinese have sociodemographic characteristics and culture that differ substantially from other US Asians, and therefore, differ in social determinants of health, health status, and disease risk. US Chinese adults are at increased risk for cardiometabolic disease, related conditions (obesity, type 2 diabetes mellitus, hypertension), and systemic inflammation that promotes disease onset and progression. Immigration to a new country can substantially impact the gut microbiome which may promote systemic inflammation. Pilot interventions indicate a high-fiber diet rich in whole grains reduced inflammation and improved obesity. Additionally, the United States Department of Agriculture (USDA) supported, evidence-based HomeStyles intervention has demonstrated feasibility, acceptability, and efficacy in improving lifestyle behaviors and home environments associated with obesity risk in families. A lack of linguistically, culturally tailored interventions to their specific health needs makes it difficult for US Chinese to implement healthy lifestyle behaviors and reduce health risks. Interventions tailored for US Chinese that could attenuate modifiable cardiometabolic risk factors, understand physiological sequelae, and bridge health equity are not currently available. Thus, the overall goal of this project is to test the efficacy of HomeStyles in improving health outcomes in US Chinese. Project aims are to: A) Culturally adapt the HomeStyles intervention through community-engaged approaches. B) Conduct a 10-week, 2-armed Randomized Controlled Trial (RCT) to test HomeStyles intervention efficacy on health outcomes (dietary intake, physical activity, self-efficacy, HbA1C, waist circumference, and BMI), hypothesizing that participants randomized to the treatment condition will have greater improvements in health outcomes than control comparators. C) Examine associations between intervention participation and gut microbiota/systemic inflammation and test hypotheses that a whole-grain rich diet adopted by those in the intervention group will increase anti-inflammatory gut bacteria, reduce inflammatory gut bacteria, and lower systemic inflammation.

NCT ID: NCT06041581 Enrolling by invitation - Stroke Clinical Trials

SHADES Mechanistic Trial

SHADES
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) is common, deadly, and costly, and adults with insomnia represent a large group of people at elevated risk of developing CVD in the future. This clinical trial will determine if our updated insomnia treatment, called the SHADES intervention, improves CVD factors thought to explain how insomnia promotes CVD and if these improvements are due to positive changes in sleep factors. A total of 200 primary care patients with insomnia and CVD risk factors will be randomized to 6 months of the SHADES intervention (internet, telephonic, and/or face-to-face cognitive-behavioral therapy for insomnia) or the active control condition (sleep education/hygiene, symptom monitoring, and primary care for insomnia). Before and after treatment, participants will complete measurements of the CVD factors (systemic inflammation, autonomic dysfunction, metabolic dysregulation, proinflammatory gene expression) and the sleep factors (insomnia symptoms, sleep onset latency, wake after sleep onset, sleep efficiency). Researchers will test whether the SHADES intervention produces greater improvements in the CVD factors than the active control condition.

NCT ID: NCT05727813 Completed - Clinical trials for Stage I Breast Cancer

To Detect Cryoimmunologic Response Induced by Early Breast Cancer Ultrasound-guided Cryoablation (ICE-study)

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The aim of our study is to examine the cryoimmunologic response and its mechanisms induced by US-guided cryoablation of small breast tumors (<2 cm) not eligible to neoadjuvant therapy. We will recruit 30 women who will undergo cryoablation and their results will be compared with a control group of 30 women, who will follow the same therapeutic pathway without performing cryoablation. All recruited patients will undergo an enrollment check, pre-cryoablation breast MRI and blood test to assess immune response, breast cancer US-guided cryoablation, post-cryoablation breast MRI and the same blood test to evaluate immunologic response. Within 21 days all patients will undergo breast surgery, with immuno-histopathological analysis on surgical specimen. At least 10 days after surgery the patient will undergo clinical breast examination, blood test to assess immune response and patient satisfaction questionnaire. Cryoablation treatment will be performed using a 14G cryoprobe under us-guidance for visualization of the ice ball surrounding the lesion. The ultrasound guide is used to ensure that the action affects the entire tumor and that therapeutic temperatures are reached in every part of the tumor. Pre- and post- cryoablation breast MRI will be performed on a 3T magnet to assess cryoablation rate of success. Artificial intelligence algorithms will also be used for this purpose. Cryoablation treatment efficacy will also be evaluated with ultrasound. The immunological fitness of cancer patients will be studied by flow cytometry, evaluating the presence of cytokines/chemokines relevant during anticancer immune response/tumor progression and for the presence of molecules released by cells during an immunogenic cell death. The goal of our study will be to demonstrate that cryoablation of breast cancer can induce an antitumor immune response. Therefore this approach could become an additional tool in the oncological treatment of breast cancer.

NCT ID: NCT05641064 Recruiting - Clinical trials for Aortic Valve Stenosis

Evaluation of Intraoperative Dexmedetomidine Use in Patients Undergoing Surgical Aortic Valve Replacement

Start date: November 22, 2022
Phase: Phase 3
Study type: Interventional

Aim of this randomized prospective study is to investigate the immunomodulatory effects of dexmedetomidine on outcomes in patients with isolated aortic stenosis after surgical aortic valve replacement.

NCT ID: NCT05488249 Recruiting - Clinical trials for Coronary Artery Disease

CCTA Coronary Hemodynamics, Systemic Inflammation and Vulnerable Plaques (COHESIVE)

COHESIVE
Start date: August 5, 2022
Phase:
Study type: Observational

Although there are numerous studies that have demonstrated the impact of systemic inflammation on coronary plaque vulnerability, there are few literature data regarding the influence of coronary plaque localization within the coronary tree (right and left coronary artery, proximal, mid-coronary and distal), on plaque composition, morphology and degree of vulnerability, in relation with systemic inflammation and coronary hemodynamics. The aim of this study is to identify: (1) the impact of plaque topography in different sites within the coronary tree (right versus left, proximal distal) on their vulnerability degree evaluated with CCTA; (2) the relationship between degree of plaque vulnerability, systemic inflammatory biomarkers and specific hemodynamic characteristics quantified by coronary shear stress computations. The study will include 100 patients with stable coronary artery disease for which data collection will be perform on: (1) Clinical, echocardiographic and ECG data; (2) cardiovascular risk assessment; (3) 128 slice CCTA evaluation of coronary tree anatomy, plaque morphology, composition and vulnerability degree; (4) systemic inflammation based on serum levels of hsCRP, IL-6, MMP-9, periostin, adhesion molecules (5) shear stress via coronary flow computational simulations.

NCT ID: NCT02629874 Completed - Endotoxemia Clinical Trials

PK/PD of EA-230 During Endotoxemia

Start date: February 2015
Phase: Phase 1
Study type: Interventional

EA-230 is a newly developed synthetic compound with anti-inflammatory properties. Pre-clinical data indicate that EA-230 may be a valuable treatment for systemic inflammation resulting from a variety of causes such as surgery, trauma, infection, irradiation and others. Although previous studies in healthy volunteers have shown an excellent safety profile, the safety and tolerability of higher doses administered per continuous infusion need to be investigated. Also, the dose-effect relation on systemic inflammation needs to be further elucidated before a phase II trial in patients can be commenced.

NCT ID: NCT02565277 Completed - Clinical trials for Systemic Inflammatory Response

The Effect of Influenza Vaccination on the Systemic Inflammatory Response and Myocardial Protection in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial

Start date: September 2015
Phase: Phase 4
Study type: Interventional

To assess the impact of influenza vaccination on the overall systemic inflammatory response in patients undergoing cardiac surgery and investigate functional and clinical outcomes in vaccinated patients postoperatively.

NCT ID: NCT01371188 Completed - Oxidative Stress Clinical Trials

Effects of Exposure to Biomass-burning Air Pollution on Lung Function, Heart Rate Variability and Inflammatory Markers in Sugarcane Workers

Start date: December 2008
Phase: N/A
Study type: Observational

Introduction: Non-mechanized sugar cane harvesting preceded by burning, an important and prevalent professional activity of agribusiness segment of the Brazilian economy, exposes workers and people of neighboring towns to high concentrations of pollutants and, therefore, potentially several risks to health hazards. Objectives: Assessing cardiopulmonary impacts and inflammatory markers in sugarcane workers and volunteers from a nearby town in non-harvest and harvest periods.