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176 active trials for Inflammation

A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti

Investigators will establish a longitudinal cohort of 3,000 adults >18 years in Port-au-Prince using multistage random sampling, and follow them for 2 to 3.5 years depending on the timing of study enrollment to evaluate the prevalence and incidence of cardiovascular disease risk factors and diseases. Cardiovascular risk factors include hypertension, diabetes, obesity, dyslipidemia, kidney disease, poor diet, cigarette smoking, physical inactivity, and inflammation. Cardiovascular disease include myocardial infarction, heart failure, stroke, and CVD mortality. It is anticipated that hypertension prevalence will be ?10% in 18-30 year olds, that hypertension incidence will be >10 events/1000 person years. Association of determinants and risk factors with CVD will also be examined. Whole blood, serum, plasma, stool, and urine samples will be biobanked for future studies.

Start: March 2019

Enhancing Adaptations to Exercise

Researchers are trying to understand how chronic inflammation affects muscle function and responses to exercise.They are also trying to determine if suppressing chronic inflammation using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise responsiveness in older adults.

Start: January 2018

The Role of the Immune and Inflammatory Systems in Hypertension

To define the cytokine and cellular immune signature of primary hypertension. Cross sectional clinical/laboratory study.

Start: May 2019

Dexmedetomidine and HIPEC

Inflammation is associated with an increased risk of cancer recurrence. Various methods have been used to decrease the inflammatory response induced by the cancer and surgery. In this study the investigators would like determine if a commonly used sedative drug (dexmedtomidine) has an impact on this inflammatory state when used as part of the anesthetic. The investigators will conduct a pilot study with 20 patients undergoing a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment. 10 patients will receive the standard of care for anesthesia during the cancer surgery and a placebo infusion of normal saline at a rate consistent to that of the study drug. 10 additional patients will receive the same standard of care anesthetic plan with the addition of an infusion of dexmeditomidine during the procedure. The investigators will measure the degree of inflammation before, during and after the surgical procedure by looking at the levels of inflammatory markers in blood samples. The goal is to determine if the addition of dexmodtomidine affects the inflammatory state of patients undergoing a HIPEC procedure. This information will be used to guide future studies aiming at decreasing cancer recurrence and improve patient outcomes.

Start: October 2021

Inflammation and Neurocognitive Damage Markers in Elderly People With Obstructive Sleep Apnea

The aging process tends to promote an overall increase in inflammation compromising the immunologic system regulation, sleep/wakefulness pattern, and neurocognitive performance. In elders, there is an increase in repetitive arousals during sleep, secondary to breathing interruption by pharynx collapse, generating a transient reduction in oxygen delivery to the brain known as obstructive sleep apnea. This lack in oxygen supply results in an inflammatory process producing brain damage. Some substances present in the blood seem to be associated to neurocognitive damage, like S100? protein, cortisol, interleukin 1-?,6 and TNF-?. In the other way, a substance called brain-derived neurotrophic factor (BDNF) enhances cognitive function, and memory consolidation improvement.

Start: August 2019

Stress, Inflammation and Immune Response Pilot Study- Aim 3

The overall goal of this study is to investigate the effects of stress and glucose intake at the molecular level including gene expression, protein and functional analysis of immune cells in real time. Aim 1- Characterizing the immune response after acute stress and glucose consumption Aim 2- Temporal mapping of the modulation of immune cell function via meditation Aim 3-Influence of meditative practice on lupus patients Aim 4-Influence of meditative practice on healthy subjects Current Clinicaltrials.gov record, will be focused on Aim-3 only. Aim-3 will test whether meditation alters neutrophil function and inflammation in patients with lupus. Study team will investigate whether patient neutrophils have altered NET formation, phagocytosis, ROS signaling and migration after ABMP. Innate immune function via analysis of monocytes by flow cytometry will also be analyzed. Other immune cell responses including CD8 T cells will also be investigated.

Start: June 2021

Effects of Parmigiano Reggiano on Muscle and Inflammatory Response to Eccentric Resistance Training in Older Adults

Aging is associated with the loss of muscle mass and function (sarcopenia) and reduced tissue regenerative capacity. Eccentric exercise (ECC) is a model of RET that can be used with the elderly, due to the ability of the muscle to combine high muscle strength production with low energy cost. ECC contractions are significantly more damaging to the muscles and produce greater muscle strength, for these reasons there is a greater risk of inducing muscle damage before the muscle is able to adapt. Parmigiano Reggiano (PR) has some peculiar bromatological characteristics. The proteins contained in it, and in particular the potentially bioactive peptide sequences, can rapidly provide the amino acids necessary to promote muscle growth and repair during exercise. Furthermore, PR can be an important source of fatty acids, of which a significant amount of short-chain fatty acids (SCFA) which are known to have important clinical effects on body composition and metabolic health and can have a systemic anti-inflammatory effect. Therefore, the central hypothesize is that PR consumed while being engaged in a RET can provide more energy substrates and improve muscle recovery, redcue inflammatory markers and improve lipid metabolism. To date, no studies have studied its function on recovery from exercise nor in the elderly.

Start: May 2021

Suvorexant on Sleep Disturbance in Patients With Chronic Insomnia and Suboptimally Controlled Type 2 Diabetes

The investigators aim to determine the effect of suvorexant on subjective total sleep time (TST) in suboptimally controlled Type 2 diabetics with chronic insomnia in a randomized placebo-controlled trial for 3 months.

Start: March 2019

Correlation of the Inflammatory Parameters With Pain and Radiological Findings in Coxarthrosis

Osteoarthritis (OA) is a functional disease with joint degeneration with subchondral and periosteal lesions. Coxarthrosis (or hip osteoarthritis) is an important cause of disability, especially in the advanced age group.Although hip osteoarthritis is often thought to be a non-inflammatory pathology, recent studies have shown that joint degeneration is correlated with the production of inflammatory factors and cartilage destroying enzymes. There are very few studies evaluating the correlation of Neutrophil lymphocyte ratio, monocyte lymphocyte ratio and Platelet lymphocyte ratio with inflammatory parameters CRP and ESR levels in hip osteoarthritis and its relation with the staging of hip osteoatritis.

Start: February 2021

Effect of a Fermented Soy Product on Cognition, Immune Status and Vaccine

The research study will test the effects of Q CAN PLUS powder on the immune, inflammatory and cognitive functions.

Start: June 2021

Impact of T Cells on Age-related Vascular Dysfunction: A Translational Approach

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States and other industrialized societies, and advanced age is the major risk factor for development of CVD. Advancing age appears to exert its pathological influence primarily via adverse functional and structural effects on arteries. Aging is associated with increased stiffness (reduced compliance) of large elastic arteries and impaired arterial endothelial function that is characterized by reductions in nitric oxide (NO)- mediated endothelium-dependent dilation (EDD). While several changes to arteries may contribute to age-associated increases in CVD risk; the development of endothelial dysfunction and stiffening of the large elastic arteries are among the most important contributors. Both are predictors of CV events and clinical CVD with increasing age. Although the importance of endothelial dysfunction and arterial stiffening with age are well established, the initiating events of these deleterious changes are elusive.

Start: October 2021

Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1

HIV infection, as well as exposure to opioids (including heroin), are associated with systemic immune activation including increased microbial translocation from the gut. The overall objective of this study is to define the impact of long-term mu-opiate receptor stimulation or blockage with medication for opiate use disorder (i.e, methadone, buprenorphine/naloxone, or extended-release naltrexone) on the kinetics and extent of immune reconstitution on HIV-1 infected people who inject opiate and initiating antiretroviral therapy.

Start: September 2021

A Study to Investigate the Effect of Vitamin D3 Supplementation on Asthma Symptoms in Adults With Asthma (VITDAS)

Asthma is a disease characterised by chronic inflammation of the airways leading to symptoms including periods of shortness of breath, wheezing and a tight chest due to airway narrowing in affected patients. Current data show that one in 12 adults are currently receiving treatment for asthma in the United Kingdom (UK), with the UK having some of the highest rates in Europe. In the winter, 30-40% of the UK population are vitamin D deficient with some asthma patients having significantly lower vitamin D levels compared to normal patients. Vitamin D has been shown to be involved in the development of immune-related disorders including asthma. Cross-sectional research has shown that reduced vitamin D levels are associated with reduced lung function, increased airway hyper-responsiveness and reduced response to glucocorticoids, suggesting vitamin D levels may also implicate asthma treatment. To date, there have been three randomised controlled trials (RCT) assessing the effect of vitamin D supplementation in adults with symptomatic asthma. These trials have not found a significant effect of vitamin D supplementation on asthma. However, these studies relied on high doses of vitamin D with long time periods between doses. There is a requirement for RCTs in adults with daily supplementation of lower doses of vitamin D as it has been suggested that daily supplementation is more effective for inducing non-classical actions of vitamin D. However, vitamin D has been found to significantly improve airway function as measured by forced expiratory volume in one second (FEV1) in adults supplemented with 100, 000 international units (IU) vitamin D intramuscularly plus 50, 000 IU oral vitamin D weekly. Therefore, the effect of daily dosing on lung function also requires investigation. Furthermore, these trials have focussed on clinical outcomes without investigating the cellular mechanisms affording protection.

Start: October 2019

Potential Harms of Untargeted Iron Supplementation in Cambodia Where Iron Deficiency is Not the Cause of Anemia

In 2016, the World Health Organization (WHO) set a global policy recommending daily oral iron supplementation (60 mg iron) for 12 weeks for all women living in countries where anemia prevalence is >40%, such as in Cambodia. However, recent studies have shown the prevalence of iron deficiency to be low in Cambodian women and that supplementation would likely only benefit ~10% of women. Iron supplementation may be harmful in women with genetic blood disorders (e.g. thalassemia), which are common in Cambodia, as these individuals are already at an increased risk of iron overload. The risks are made greater by the fact that iron absorption from most common form of supplementation, ferrous sulfate, is low. Typically less than 20% is absorbed in the gut; the remaining 80% passes unabsorbed into the colon where it can increase the risk of pathogen growth and gut inflammation. Alternatively, ferrous bisglycinate is a newer supplemental form of iron. This amino acid chelate has 2-4x higher bioavailability than ferrous sulfate and is associated with fewer GI side-effects. In view of WHO policy and risks of supplementation, there is a need to determine the potential for harm, and if novel forms of iron supplements are safer.

Start: December 2019

The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients

The purpose of this study is to examine two mechanistic changes: emotion processing (awareness, expression and acceptance) and cholinergic anti-inflammatory processes (HRV and cytokine expression) through which an Art Therapy (AT) intervention reduces depression, pain and fatigue.

Start: June 2019

The Role of Large Artery Plaque Imaging Features in Predicting Inflammation and Cognition

The invesigators propose a clinical study on patients undergoing carotid surgery (endarterectomy). The invesigators will determine carotid artery imaging features associated with (1) vessel wall inflammation, (2) downstream brain inflammation, and (3) cognitive benefit from surgery. This project will uncover links between inflamed carotid plaque and downstream brain inflammation. The invesigators will also determine carotid plaque imaging features predicting cognitive benefit from carotid surgery.

Start: February 2017

Anxiety, Inflammation, and Stress

This study investigates whether the anxiolytic effects and anti-inflammatory properties of cannabis vary as a function of the ratio of CBD to THC, with the goal that these effects may shed light on the mixed data linking cannabis use and anxiety. Individuals with mild to moderate anxiety who elect to use cannabis (smoked flower or edible) will complete four weeks of observation. Participants complete cognitive tasks, a substance use history, health questionnaires concerning sleep and physical activity, and a blood draw at four different time points (Baseline, after 2 weeks of cannabis use, and immediately before and after self-administration after 4 weeks of use) with the use of a mobile pharmacology laboratory, which goes to a convenient location for each participant to self-administer their cannabis. Participants are then followed for five months to self-report on cannabis use, anxiety, subjective cognitive functioning, sleep quality, and other mental health symptoms.

Start: April 2018

Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms

Rationale: Histological inflammation of the prostate is a common finding in the results of the histopathological examinations after a prostate biopsy or a transurethral or open prostatectomy. Several studies have investigated the role of prostatic inflammation in the development of prostatic enlargement and pathogenesis of Lower Urinary Tract Symptoms (LUTS). Therefore, prostatic inflammation could be a potential treatment target for men with LUTS. Objective: The aim of the study is the development and the validation of a nomogram based on clinical parameters that could predict the presence of prostatic inflammation. Study design: Non-interventional, multicentric, cross-sectional, observational prospective study. Study population: Men, age ? 40 yrs, with LUTS who will undergo any prostatic surgery for BPH (Open, laparoscopic, robotic, transurethral resection/enucleation, laser prostatectomy) or TRUS-biopsy according to the standard clinical practice of the participating urologists Intervention: All included males receive standard care for their symptoms according to the physician's practice. For this study, baseline demographic and clinical characteristics of the patients are recorded and correlated with the histological outcome. Main study parameters/endpoints: Development and validation of the Prostatic Inflammation Nomogram Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional treatment or intervention related to the study is required. Therefore no negative outcomes are expected as the standard treatment is unchanged. There is no additional burden for the patients.

Start: September 2020

Colchicine in HFpEF

Heart failure is a growing epidemic that affects up to 500,000 individuals in Canada, with 50,000 new cases being diagnosed each year. Half of these will have HF with preserved ejection fraction (HFpEF). HFpEF has been associated with high rates of morbidity, mortality, and health care expenditures. Its pathophysiology remains poorly understood, and positive medication trial results to date have been rare. Inflammation is strongly associated with a profibrotic activation in HFpEF, which is in turn associated with the severity and prognosis of the disease. Colchicine is a potent anti-inflammatory drug which properties relate to the suppression of tubulin polymerization and inflammasome inhibition, thus reducing the production of IL-1? and IL-18. The investigators thus propose a pilot study of 6 months follow-up duration that will test the efficacy and safety of 2 dosing regimens of colchicine (vs. placebo) in patients with HFpEF.

Start: July 2021

Management of Cardiovascular Disease in Kidney Disease (MaCK) Study

Cardiovascular disease (CVD) is the largest concerns for patients with Chronic kidney disease (CKD). At present time the investigators do not have proven effective strategies to reduce high CVD related deaths in CKD. This study assesses a novel therapy (hydroxychloroquine, HCQ) for the treatment of CVD in patients with CKD. This is the first human proof-of-concept study and is planned to be conducted among US Veterans, who suffer from both CKD and CVD at a disproportionately greater rates. The outcome of this study has the potential to provide an entirely new line of therapy for the treatment of CVD in CKD.

Start: December 2018