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Inflammation clinical trials

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NCT ID: NCT05434130 Recruiting - Inflammation Clinical Trials

Modulating Exercise Dosage to Improve Concussion Recovery

MEDIC
Start date: August 5, 2022
Phase: Phase 2
Study type: Interventional

Aerobic exercise has emerged as an effective treatment to reduce sport-related concussion symptom severity, yet existing work lacks rigor regarding the precise exercise volume and intensity required to elicit therapeutic effects, how exercise can alter concussion-related pathophysiology, and whether exercise can prevent the development of secondary sequelae. Our objective is to examine if a high dose exercise program (higher volume than currently prescribed at an individualized, safe intensity level) initiated within 14 days of concussion results in faster symptom resolution, altered physiological function, or reduced secondary sequalae. Findings from this research will lead to more rigorous and precise rehabilitation guidelines and improved understanding about how exercise affects neurophysiological function among adolescents with concussion.

NCT ID: NCT05420012 Recruiting - Heart Failure Clinical Trials

The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation

Start date: May 1, 2023
Phase: Phase 4
Study type: Interventional

The concept that direct stimulation of soluble guanylate cyclase (sGC) could be a particularly effective approach to increase cyclic guanosine monophosphate (cGMP) in conditions of increased inflammation/oxidative stress, endothelial dysfunction, and reduced nitric oxide (NO) bioavailability. Thus, the aim of the proposed study is to examine the effect of Vericiguat on peripheral vascular function, inflammatory status, and patient health status. The study also aims to identify patients who are particularly likely to benefit from Vericiguat treatment and predict that these patients will be defined by baseline peripheral vascular dysfunction and high inflammatory state.

NCT ID: NCT05415397 Recruiting - Inflammation Clinical Trials

Treating Immuno-metabolic Depression With Anti-inflammatory Drugs

INFLAMED
Start date: September 28, 2022
Phase: Phase 3
Study type: Interventional

As the role of (neuro)inflammation in depression is emerging, augmentation of antidepressant treatments with anti-inflammatory drugs such as celecoxib has shown encouraging preliminary results. However, inflammation is not present in all depressed patients. Depression is heterogeneous: patients express diverse and sometimes opposing symptoms and biological profiles. The investigators of the present trial recently introduced the concept of ImmunoMetabolic Depression (IMD), characterized by the clustering of inflammatory/metabolic dysregulations and atypical, energy-related symptoms (hyperphagia, weight gain, hypersomnia, fatigue and leaden paralysis), and present in approximately 30% of cases. Converging evidence suggests that in this subgroup of depression cases, inflammation may exert a crucial pathobiological mechanism, representing therefore an actionable therapeutic target. In this trial IMD will be applied as a tool to personalize treatment, by matching depressed subjects with IMD with a targeted anti-inflammatory add-on treatment. In this study, 140 persons with IMD will be selected. In this specific group of patients, the investigators will test whether celecoxib add-on (400 mg/d) is more effective than placebo in the treatment of depression through a 12-week double-blind, randomized (1:1), placebo-controlled trial. By selecting specifically depressed patients with IMD, the proposed treatment selectively targets key inflammatory pathophysiological pathways to enhance clinical outcome for depression. This personalized approach is expected to lead to large health gains for a sizable proportion of patients. The main hypothesis is that the group of patients with IMD receiving TAU + celecoxib, as compared to the TAU + placebo, will show a better symptom course over the 12-week follow-up.

NCT ID: NCT05414370 Recruiting - Acute Lung Injury Clinical Trials

Hyperoxia Induced Pulmonary Inflammation and Organ Injury: a Human in Vivo Model

Start date: December 2, 2022
Phase: N/A
Study type: Interventional

Oxygen is the most commonly administered therapy in critical illness. Accumulating evidence suggests that patients often achieve supra-physiological levels of oxygenation in the critical care environment. Furthermore, hyperoxia related complications following cardiac arrest, myocardial infarction and stroke have also been reported. The underlying mechanisms of hyperoxia mediated injury remain poorly understood and there are currently no human in vivo studies exploring the relationship between hyperoxia and direct pulmonary injury and inflammation as well as distant organ injury. The current trial is a mechanistic study designed to evaluate the effects of prolonged administration of high-flow oxygen (hyperoxia) on pulmonary and systemic inflammation. The study is a randomised, double-blind, placebo-controlled trial of high-flow nasal oxygen therapy versus matching placebo (synthetic medical air). We will also incorporate a model of acute lung injury induced by inhaled endotoxin (LPS) in healthy human volunteers. Healthy volunteers will undergo bronchoalveolar lavage (BAL) at 6 hours post-intervention to enable measurement of pulmonary and systemic markers of inflammation, oxidative stress and cellular injury.

NCT ID: NCT05411900 Recruiting - Pain Clinical Trials

BotulInum Toxin Type A for Peripheral Neuropathic Pain in subjEcts With Carpal Tunnel Syndrome

INjECT
Start date: May 25, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of the study is to assess the safety and efficacy of repeated administrations of BoNT-A in subjects with NP attributable to carpal tunnel syndrome (CTS) through a randomized, double-blind, placebo-controlled study. Further research has shown that BoNT-A has analgesic properties independently from its action on muscle tone, possibly by acting on neurogenic inflammation. Therefore, the study drug may be better than other treatments surgical or non-surgical currently available for the treatment of CTS.

NCT ID: NCT05407090 Recruiting - Clinical trials for Bariatric Surgery Candidate

The Effect of Probiotics on Systemic Inflammation and Metabolic Endotoxemia in Patients Undergoing Bariatric Surgery

Start date: August 2, 2021
Phase: N/A
Study type: Interventional

This study explores the effects of probiotic administration on the outcomes of surgical treatment, and also on the state of the intestinal microbiota and the intestinal barrier. The study protocol is designed as a randomized double-blind placebo-controlled clinical trial. Patients qualified for bariatric surgery will be randomized to receive probiotics or a placebo for 12 weeks. Researchers are going to evaluate changes in intestinal microbiota, epithelial permeability, weight loss, postoperative complications, and serum parameters reflecting inflammation, metabolic profile, and metabolic endotoxemia.

NCT ID: NCT05394363 Recruiting - Obesity Clinical Trials

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

GenV
Start date: October 4, 2021
Phase:
Study type: Observational

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions, exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all babies born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of babies born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

NCT ID: NCT05392582 Recruiting - Clinical trials for Chronic Inflammation

MicroRNA Regulation of Chronic Inflammation During Aging

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

This is an observational study enrolling healthy individuals aged 18-35 and 65y and older to determine the health of immune cells in the blood and how these cells create inflammation and effect health as we age. It is hoped that once the nature of this relationship has been discovered we can more effectively design therapies to reduce this inflammation. The enrollment goal is 40 participants. The study will occur over the course of 1 month which will include a screening visit and a second visit where the participants will undergo an oral glucose tolerance test, blood draws and leg strength & exercise tests.

NCT ID: NCT05366270 Recruiting - Clinical trials for Major Depressive Disorder

Peripheral Neuroimmune Mechanisms of Hyperthermia

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

The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder.

NCT ID: NCT05363527 Recruiting - Depression Clinical Trials

Aging and Reward System Response to Inflammation and Anxiety Study

ARIA
Start date: March 29, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to use an experimental inflammatory challenge to examine whether older adults with symptoms of anxiety experience loss of pleasure or loss of motivation when they are exposed to inflammation. Loss of pleasure or loss of motivation will be evaluated using self-report questionnaires, computer tasks, and during a brain scan.