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Inflammation clinical trials

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NCT ID: NCT05989750 Recruiting - White Spot Lesion Clinical Trials

Air-polishing With Erythritol During Orthodontic Tretament

AirPort
Start date: September 11, 2023
Phase: N/A
Study type: Interventional

Patients with multi-bracketed fixed orthodontic treatment are at increased risk of developing white spot lesions (WSL) and gingivitis. Various preventive strategies have been examined to prevent the development of WSLs. During initial non-surgical periodontal therapy, the use of subgingival air-polishing with erythritol powder has shown promising results in reducing deep pockets and gingival inflammation. The efficacy of its use as monotherapy in preventing WSLs and gingival inflammation in patients during orthodontic treatment, has not yet been tested. The primary objective of the present study is to compare the effectiveness of an air-polishing device used as monotherapy versus ultrasonic instrumentation (the current gold standard procedure) in preventing white spot lesions (WSL) and gingivitis among young patients undergoing multi-bracketed fixed orthodontic treatment.

NCT ID: NCT05972564 Recruiting - Obesity Clinical Trials

The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function

SADIE2
Start date: September 6, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This trial will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.

NCT ID: NCT05969275 Recruiting - Sepsis Clinical Trials

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

UC-CISSII
Start date: February 14, 2024
Phase: Phase 2
Study type: Interventional

Septic shock is associated with substantial burden in terms of both mortality and morbidity for survivors of this illness. Pre-clinical sepsis studies suggest that mesenchymal stem (stromal) cells (MSCs) modulate inflammation, enhance pathogen clearance and tissue repair and reduce death. Our team has completed a Phase I dose escalation and safety clinical trial that evaluated MSCs in patients with septic shock. The Cellular Immunotherapy for Septic Shock Phase I (CISS) trial established that MSCs appear safe and that a randomized controlled trial (RCT) is feasible. Based on these data, the investigators have planned a phase II RCT (UC-CISS II) at several Canadian academic centres which will evaluate intermediate measures of clinical efficacy (primary outcome), as well as biomarkers, safety, clinical outcome measures, and a health economic analysis (secondary outcomes).

NCT ID: NCT05968378 Recruiting - Obesity Clinical Trials

Diet, Immunometabolism and Non-alcoholic Fatty Liver Disease

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

This study will assess the impact of 8-hour time restricted eating (8 hours of eating, 16 hours fasting) combined with a Mediterranean diet on metabolism and inflammation in adults with non-alcoholic fatty liver disease (NAFLD).

NCT ID: NCT05967741 Recruiting - Clinical trials for Platelet Aggregation, Spontaneous

The Effects of Dietary Erythritol on Platelet Reactivity and Vascular Inflammation

EASI
Start date: July 20, 2023
Phase: N/A
Study type: Interventional

The purpose is to conduct a dietary intervention study in which human participants will consume beverages sweetened with erythritol or aspartame, each for 2 weeks, in a randomized crossover design

NCT ID: NCT05967715 Recruiting - Hypertension Clinical Trials

Exercise Training Influences Gut Microbiota and Cardiovascular Health Through Inflammation Control in Adult Hypertensive Population: the MicroFit Study

Start date: April 3, 2023
Phase: N/A
Study type: Interventional

Cardiovascular diseases are the number 1 cause of death globally, taking an estimated 17.9 million lives each year (31% of deaths worldwide). Hypertension, with 1.13 billion people affected worldwide, is the leading risk factor for global mortality. Physical inactivity is among the modifiable cardiovascular risk factors. While the beneficial effects of physical activity on cardiovascular system are widely known, the mechanisms involved are not completely understood. Both exercise training and hypertension are linked to inflammation. Furthermore, there is evidence that gut microbiota regulates inflammatory patterns. Recent investigations showed a relationship between exercise training and the composition/functionality of the gut microbiota. Anyway, the modification of the composition and functionality of the gut microbiota in hypertension due to the exercise training and the relative involvement of oxidative stress and inflammation are not completely understood. In literature an association between gut microbiota composition and arterial stiffness is described, in particular, the investigators observed both a direct correlation between arterial stiffness and abundances of bacteria associated with altered gut permeability and inflammation; and an inverse relationship between arterial stiffness, microbiota diversity, and abundances of bacteria associated with most fit microbiota composition. Anyway, while these association were stable in animal studies, in human studies none of the identified interventional trials was able to demonstrate this relationship. Of note, only half of human studies measured BP, and very few adjusted the vascular analyses for BP variation, which is a major determinant of arterial stiffness. This is a non-profit, monocentric, non-pharmacological interventional study, a randomized controlled trial with three intervention arms, partial double-blind, aiming to verify the hypothesis that, in hypertensive patients in primary prevention with cardiovascular risk factors, physical exercise favorably modifies the intestinal bacterial flora compared to the probiotic, with a positive impact on cardiovascular health, and to demonstrate that this involves inflammation modulation. There will be 3 intervention arms, with 1:1:1 stratified randomization by gender: 1. Administration of controlled physical activity training; 2. Administration of probiotic; 3. Administration of placebo. Arms 2 and 3 will be double-blind. The intervention will last for three months, followed by a 6-month follow-up period. Afterwards, the medical team may be contacted for further tests/assessments or simply for information about the participant's health status, for a total duration of 24 months. The investigators hypothesize that hypertensive patients in cardiovascular primary prevention have a dysbiotic gut microbial signatures, that could be a new marker of early vascular aging. Secondly, the investigators anticipate that exercise training will modify both gut microbiota and hemodynamic profile, and that a relationship exists between gut microbiota and hemodynamic modifications. Thirdly, the investigators expect that the beneficial effects of exercise training are driven by positive changes in the inflammatory modulators.

NCT ID: NCT05964127 Recruiting - Clinical trials for Peri-Implantitis and Systemic Inflammation

Peri-implantitis and Systemic Inflammation

LASSO
Start date: July 19, 2023
Phase: N/A
Study type: Interventional

To investigate the effects of peri-implantitis (a disease around dental implants) and its treatment at both local and systemic levels using clinical and biological parameters. One study with two parts which will run simultaneously. An initial observational study comparing cases and controls and a subsequent interventional study in which the cases will proceed to treatments and all participants will be followed up for 6 months.

NCT ID: NCT05961865 Recruiting - Atrial Fibrillation Clinical Trials

Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation

POLICARDIOFA
Start date: July 11, 2023
Phase:
Study type: Observational

It is a non-pharmacological (biological), spontaneous observational study. The main objective is to evaluate the correlation between inflammation markers and local adiposity, clinical risk factors and their possible variation following an AF ablation procedure

NCT ID: NCT05955547 Recruiting - Inflammation Clinical Trials

The New ICU Prognostic Score APACHE-INf

Start date: June 1, 2023
Phase:
Study type: Observational

Intensive care units (ICUs) aim to provide specialized care for patients with high morbidity and mortality risks. To effectively identify patients requiring urgent diagnosis and treatment, various scoring systems have been developed, including APACHE-II. However, these systems primarily focus on evaluating organ dysfunction and do not consider the patient's nutritional status or the role of inflammation. Recent studies have highlighted the crucial role of inflammation in patient outcomes, emphasizing the need to incorporate inflammatory parameters into scoring systems for accurate prognosis prediction. Additionally, nutritional status upon ICU admission has been largely overlooked in current scoring systems, despite its significant impact on patient outcomes. Malnourished patients have higher risks of complications, prolonged hospital stays, and increased mortality rates. Adequate nutrition supports immune function, tissue repair, and the response to therapeutic interventions, ultimately minimizing complications. Integrating nutritional assessment into existing scoring systems allows for early identification of malnourished patients and timely interventions, improving overall care quality in the ICU. Considering the importance of inflammation and nutritional status, this study aims to develop a new scoring system by adding inflammatory and nutritional parameters to APACHE II score. This comprehensive approach holds promise for enhancing patient outcomes, accurately evaluating clinical severity, and facilitating immediate interventions in critical care settings.

NCT ID: NCT05949710 Recruiting - Obesity Clinical Trials

Explore the Relationship Between Heart Rate Variability, Body Mass Index, Inflammation, and Insulin Resistance.

Start date: September 11, 2023
Phase: N/A
Study type: Interventional

The findings will serve as a reference for clinical professionals to promote exercise among the general population and will provide evidence of whether different exercise amounts are recommended for individuals with different BMIs for improving HRV.