1,848 Clinical Trials for Various Conditions
The research aims to understand how a specific type of medication called Sodium-glucose co-transporter 2 (SGLT2) inhibitors affect cardiorenal inflammation.
Inflammation
This is a randomized, investigator-blinded, self-controlled pilot study of the physiologic response to topical moisturizers among older adults with dry skin. The overarching hypothesis is that skin barrier decline is an important source of chronic inflammation, and that skin barrier restoration with moisturizers can reduce serum biomarkers of inflammation. The primary objective is to determine the feasibility for a larger trial, and the secondary objectives are to determine the extent to which measures of serum inflammation, skin barrier function, and the skin microbiome change in response to moisturizers. Participants will be asked to apply one of two topical moisturizers that are widely available over the counter in the US (Vaseline® 100% pure petroleum jelly or CeraVe® moisturizing cream) once daily for 4 weeks to the front of the torso, buttocks, arms, and legs. Subjects will act as their own control (i.e. they will be asked to apply the study moisturizer they are randomized to for one intervention period (4 weeks) and not to apply topical moisturizers for the other 4- week intervention period). Participants will be randomized in a 1:1:1:1 ratio to one of 4 treatment groups: i. no intervention then CeraVe; ii. CeraVe then no intervention; iii. no intervention then Vaseline; iv. Vaseline then no intervention. At each visit (baseline, week 4, and week 8), participants will undergo skin barrier testing, skin microbiome sampling, and phlebotomy to measure serum inflammatory markers.
Inflammation, Skin Inflammation, Aging
This study aims to investigate the impact of various healthy diets, specifically a modified plant-based Mediterranean diet, on the gut microbiome and overall well-being post-colonoscopy. The investigators hypothesize that certain diets can positively influence gut bacteria, reducing inflammation and enhancing metabolic signals. To explore this, they will utilize metagenomic testing on stool samples to analyze the DNA of gut microorganisms. Additionally, they will conduct immune profiling on serum samples and perform metabolomic analysis to comprehensively evaluate the diet-induced changes in immune response and metabolic pathways. This multi-faceted approach will help them understand how dietary changes affect the composition and function of the gut microbiome, immune function, and overall metabolism.
Colorectal Polyp, Inflammation, Dietary Intervention, Microbiota, Colorectal Neoplasms, Metabolomics
The goal of this observational study is to learn about inflammation in those with relapsing remitting Multiple Sclerosis (MS). The main questions it aims to answer are: * How does abnormal neural inflammation compare to cellular and molecular inflammation in MS? * Once treated, why does abnormal inflammation persist?
Multiple Sclerosis
To determine the effect of early metoprolol administration after non-traumatic subarachnoid hemorrhage (SAH).
Non-Traumatic Subarachnoid Hemorrhage
The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as "vaping" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored. The purpose of this study is to directly asses the mechanistic role of inflammation in this dysfunction.
Electronic Cigarette Use, Endothelial Dysfunction, Inflammation
The goal of this clinical trial is to test the ability of HT-6184 to decrease inflammation and pain in patients after third molar removal. The main question it aims to answer are: * Does HT-6184 decrease inflammation in patients after third molar removal? * Does HT-6184 decrease pain in patients after third molar removal? Participants will be asked to do the following during the clinical trial: * Take a single oral dose of HT-6184 or placebo * Allow a oral surgeon remove their third molar teeth * Blood draws on 5 occurrences * Rate their pain intensity * Attend two follow-up appointments on day 1 and day 2 after third molar removal * Participate in one follow-up phone call 5-7 days after third molar removal
Pain
This is a multicenter, double-masked, randomized, vehicle-controlled, parallel-comparison study conducted at sites in the United States (US) in subjects undergoing routine unilateral cataract extraction and lens replacement (CELR) surgery via phacoemulsification
Inflammation
This study is a mechanistic randomized controlled trial that investigates whether inhibition of tumor necrosis factor signaling via intravenous infusion of infliximab improves psychomotor speed and executive functioning in depressed individuals who exhibit an inflammatory phenotype.
Depressive Disorder, Major, Inflammation
The purpose of this research study is to determine the effectiveness of low dose colchicine (LoDoCo) on measures of exercise capacity, physical function, frailty, and quality of life, among patients with heart failure with chronic stable preserved ejection fraction (HFpEF) and systemic inflammation. The use of LoDoCo in this study is considered investigational as it has not been approved by the Food and Drug Administration (FDA) for the treatment of exercise capacity in patients with HFpEF. Participants will undergo a 1-day screening that includes a blood draw and physical examination. If deemed eligible for the study, participants will undergo a baseline visit within 2 weeks of screening visit that includes physical examination, exercise testing, echocardiography and completion of quality-of-life surveys. Participants will also be randomized at this visit (randomly assigned to a group) to receive either LoDoCo or placebo (inactive substance) for 3 months. Participants will be called back at 3 months for repeat physical examination, blood draws, echocardiography, exercise testing and completion of quality-of-life surveys. Each visit will take about 3 hours. Total study duration is about 3 months.
Heart Failure, Inflammation
This study will determine if ingesting a beet-based supplement with nitrates for 2 weeks moderates exercise-induced inflammation.
Inflammatory Response, Metabolic Disturbance, Immune Suppression
Almonds are a good source of beneficial compounds. This study will investigate if eating almonds everyday for 12 weeks can affect gut health and inflammation in persons with metabolic syndrome. Investigators will measure changes in metabolism, heart health, and the levels of vitamins and other compounds from almonds.
Metabolic Syndrome, Dysbiosis, Inflammation
This study evaluates the relationship between weight loss, circulating inflammatory markers and lipids from 24 patients before and after 6 months of pharmacotherapy as a standard of care for anti-obesity treatment
Obesity
The goal of this clinical trial is to learn about the effects of inflammation-lowering therapy on mobility and disability in older adults. The main questions it aims to answer are: * Will therapy improve walking speed/pace? * Will therapy improve levels of blood inflammation markers and other indicators of physical, cognitive and immune function? Participants will be asked to receive injections of drug or placebo every 4 weeks for 24 weeks. They will also be asked to undergo testing that assesses physical function, thinking ability and brain health, breathing capacity, and blood vessel stiffness, and will have blood samples collected to measure immune function and to create a bank of samples for future testing. Comparisons will be made between those who receive drug and those who receive placebo.
Inflammation, Frailty
This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.
Insomnia Chronic, Inflammation
To determine if coating miniscrews with K21 would increase the success rate of orthodontic miniscrews by reducing adjacent tissue inflammation.
Inflammation Caused by the Placement of a Temporary Anchorage Device
The investigator will study the origin of fungal translocation in HIV, its relationship to the mycobiome, and its relationship to lung function and inflammation. Supported by the preliminary data and published studies, this project is based on the premise that circulating BDG derived from microbial translocation stimulates inflammation and worsens lung function in PWH. Chronic obstructive pulmonary disease (COPD) is a significant public health problem with few therapies that modify disease trajectory. COPD is a leading cause of mortality in the United States associated with increased morbidity and healthcare costs. Long-acting bronchodilators and inhaled corticosteroids are mainstays of therapy that control symptoms and reduce acute exacerbation frequency, but do not have a significant impact on mortality or lung function trajectory. The National Heart, Lung, and Blood Institute's COPD National Action Plan focuses on the critical need for research to characterize COPD risk factors and disease mechanisms in order to improve the understanding of causes and progression of disease. The ultimate goal is to provide precision therapy to appropriate patient subgroups to preserve health or arrest disease progression. Microbial organisms in the gut may have a profound effect on lung disease. The role of the gut-lung axis, defined as the cross-talk between gut microbiota and the lungs, in the pathogenesis of chronic respiratory diseases is emerging as an area of interest. Perturbations of gut microbiota characterized by low microbial diversity and changes in microbiota abundance are linked to childhood asthma risk, airflow obstruction in adult asthma, and severe lung dysfunction in cystic fibrosis. Studies in animals show that both a high fiber diet that modulates gut microbiota and an abundance of beneficial bacterial strains attenuate inflammation, emphysema, and COPD development in response to cigarette smoke exposure in murine models. In humans, recent investigations show differences in the gut microbial communities between COPD patients and healthy individuals as well as shifts in the gut microbiome with acute exacerbations of COPD.
HIV Infections, Inflammation, COPD
Recent research evidence suggests that cottonseed oil (CSO) may have both direct and indirect anti-inflammatory and anti-oxidative impacts linked to bioactive components of CSO and favorable alterations in lipid metabolism. These impacts are directly related to non-communicable diseases such as diabetes, cardiovascular diseases, and cancer. Our overarching hypothesis is that the effect of CSO consumption on oxidative stress markers (isoprostanes), inflammatory cytokines, metabolic biomarkers, and bile acid metabolism will be beneficial for reversing disease pathophysiology linked to oxidative stress, inflammation, and bile acids. Our long-term goal is to establish effective and practical therapeutic strategies utilizing dietary incorporation of CSO to prevent or reverse these diseases. The following hypotheses will be tested in the proposed investigation: H1: CSO consumption will lower exercise-induced oxidative stress, and the effect of CSO will be greater than that of OO for lowering of exercise-induced oxidative stress. H2: CSO consumption will lower inflammatory cytokines and metabolic markers linked to the inflammation process in human participants, and the effect of CSO will be greater than that of OO for lowering inflammation. H3: Features of serum bile acids, serum metabolomes, and lipidomes distinguishing CSO and OO treatment correspond to metabolic pathways illuminating the health benefits of CSO treatment. H4: Metabolic and inflammatory impacts of dietary oils will be greater for 60 g/d of CSO compared to 30 g/d.
Inflammation, Healthy, Oxidative Stress, Metabolic Syndrome
Vigorous exercise bouts result in significant inflammation and muscle soreness. Our research group has published several papers showing that ingestion of various types of fruits enhances inflammation resolution after exercise. Mangoes have a unique nutrient profile (carotenoids, polyphenols, sugars, vitamins) that we hypothesize will mitigate post-exercise inflammation and muscle soreness. This study will examine the effect of 2 cups/day frozen mango ingestion (2 weeks, 330 g/day) in moderating exercise-induced (2.25 h cycling) inflammation and muscle soreness in a randomized crossover trial. Participants will include 20 male and female young adult cyclists (ages 18-60 years) who are capable of cycling 2.25 h in the laboratory on trainers. In random order, the cyclists will supplement their diets with 2 cups/day mangoes with 1 cup water or 1 cup water alone for two weeks, followed by the 2.25-h exercise challenge. Blood and urine samples will be collected pre- and post-2 weeks supplementation. Additional blood samples will be collected immediately post-exercise, and then 1.5-h, 3-h, and 24-h post-exercise. Urine samples will be analyzed for mango-related metabolites to confirm compliance to the supplementation regimen and to establish statistical relationships with inflammation-related outcomes. The blood samples will be analyzed for novel, cutting-edge outcomes related to inflammation including 70 oxylipins, inflammasome activation, and pro-inflammatory cytokines that we have previously shown are sensitive to exercise and nutrition-based interventions. If the data support our hypothesis, mango ingestion will be viewed as a nutritional strategy to counter exercise-induced inflammation by fitness enthusiasts and athletes who exercise vigorously on a regular basis.
Inflammatory Response, Muscular Injury
This is a 4-month randomized controlled trial to evaluate the feasibility of 'good and very good' adherence to the Mediterranean dietary pattern and to a high-fermented-food diet by individuals with Systemic lupus erythematosus (SLE).
Lupus Erythematosus, Systemic
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.
Anhedonia, Inflammation, Anxiety, Aging, Depression
Caribbean Latino adults are a vulnerable population at risk for developing osteoporosis. In addition to lifestyle factors, such as dietary intake, the investigators hypothesize that a unhealthy gut microbial environment coupled with high inflammation contributes to the risk of developing osteoporosis. There has been little research conducted on mechanisms underpinning how a low-intensity dietary intervention, including supplementation with daily yogurt, can affect the gut health of Caribbean Latino adults. The study objectives are to: 1) determine whether daily yogurt supplementation reduces bone turnover (biomarkers of overall bone health) and inflammation compared to a control group that maintains their usual diet (void of yogurt); and 2) collect preliminary data on the effects of daily yogurt supplementation on the gut microbiome compared to diet control group.
Osteoporosis, Inflammation
Background: Heart failure is a serious health condition. Researchers believe inflammation plays a role. They want to see if adding an additional heart drug to a person s treatment can help treat heart failure with preserved ejection fraction (HFpEF). Objective: To learn if chronic inflammation is high in heart failure and if taking dapagliflozin along with the standard of care medicines for 6 months will reduce inflammation and improve heart function in people with HFpEF. Eligibility: People aged 18 and older who have heart failure and qualify for dapagliflozin therapy. Healthy adult volunteers are also needed. Design: * Participants will be screened with: * Medical history * Physical exam * Heart function tests * X-ray scans of the heart and blood vessels. They may receive medicines to slow their heart rate or make their heart blood vessels bigger. An intravenous (IV) catheter will be placed in their arm to inject contrast. * Blood and urine tests * Participants will have up to 3 study visits. Some screening tests will be repeated. Participants will take one tablet of the study drug daily for 6 months. -Participants will have an imaging scan of their heart and blood vessels. They will receive a contrast and stress medicine through an IV to view blood supply. Participants will have a stress test that measures exercise ability. They will wear sticky pads on their chest, a blood pressure cuff, and a mask. They will also have a 6-Minute Walk Test. Participants will complete questionnaires about their symptoms and their health. Participants may be on the study for up to 6 months. They will have a follow-up phone call 1 month after treatment ends. ...
Myocardial Dysfunction, Heart Failure, Inflammation
In the Lean and Obese Dietary Inflammation (LODI) study, the primary goal is to determine the effect of short-term intake of high dietary fat (5 days) compared to low fat intake (5 days) in a cross-over design in older adults (men and women) with normal body weight or obesity. Inflammation will be examined by measuring serum endotoxin and other markers, as well as the fecal microbiota.
Obesity, Inflammation, Dietary Fat
The goal of this project is to elucidate interactions between the gut microbiome, anti-inflammatory/anti-oxidant food metabolomic signatures, and human inflammation phenotypes. Inflammation plays both direct and indirect roles in the development of type 2 diabetes (T2D), atherogenic cardiovascular diseases, and other causes of morbidity and mortality. Aronia melanocarpa (Aronia berries) are rich in bioactive polyphenolic compounds, which have been shown to lower inflammation and favorably impact metabolism. However, there is tremendous inter-individual variability in the bioavailability of polyphenolics and production of bioactive phenolic metabolites in the colon that depends, at least in part, on digestive metabolism by the gut microbiota. Little is known about the complex interactions among the gut microbiome, anti-inflammatory food metabolomic signatures, and human inflammation phenotypes. This study will utilize a systems-level approach to disentangle these complex interactions. The specific study objectives are as follows: 1. to determine the impact of Aronia supplementation on inflammation, metabolic health, and gut microbiome composition 2. to determine the static and dynamic metabolomic signature of Aronia based on an Aronia supplementation period and responses to a high-fat meal challenge
Inflammation, Metabolic Disorder, Hypertriglyceridemia
Dietary incorporation of pulse crops may be an effective way to lower unhealthy elevations in serum bile acids. These elevations play a direct role in promoting obesity-related diseases estimated to be present in about one third of the US adult population, including non-alcoholic fatty liver disease and type 2 diabetes. The overarching hypothesis for this study is that pulse consumption increases bile acid secretion and excretion, which will decrease toxicity linked to excess accumulation of bile in the liver, improve metabolism, and lower resulting levels of bile acids in the serum. In direct alignment with the USDA-AFRI Food, Safety, Nutrition, and Health priority to address obesity and related chronic disease with increased fruit and vegetable consumption and also with the American Pulse Association call to investigate the impact of regular pulse consumption on human physical well- being, the long-term research goal of this study is to establish effective and practical therapeutic strategies utilizing dietary incorporation of pulse crops to prevent or reverse obesity driven diseases. The specific objectives in this proposal are to: 1. determine the impact of acute lentil ingestion on serum postprandial bile acid responses and composition in a human cohort with obesity, and 2. determine the impact of daily lentil consumption for 12 weeks on serum fasting and postprandial bile acid concentrations and composition in an overweight or obese cohort with elevated postprandial triglycerides. This proposal is being submitted in response to the American Pulse Association commodity board sponsored topic of investigating the impact pulse crop consumption on health.
Inflammation, Hypertriglyceridemia, Metabolic Disease, Lipid Metabolism Disorder, Hyperlipidemias, Bile Acid Malabsorption
The purpose of this study is to determine if 2-weeks supplementation with blueberries (1 cup/day) compared to placebo can mitigate muscle soreness and damage, and improve inflammation resolution and metabolic recovery during a 5-day period after engaging in an acute, 90-minute bout of eccentric exercise. The primary outcome will be plasma oxylipin levels, extending previously collected data showing that blueberry ingestion decreases post-exercise oxylipins generated from cytochrome P450 enzymes.
Muscular Injury
The goal of this randomized control trial (RCT) is to test the feasibility and acceptability of a lifestyle intervention with a focus on implementing a high dose Mediterranean Diet protocol with physical activity to reduce systemic inflammation and body weight among WTC first responders having overweight/obesity and PTSD. The findings of this study will demonstrate the suitability of the proposed approach to reduce comorbidities among similar populations exposed to traumatic events; the findings will also inform the World Trade Center Health Program's extensive research and clinical efforts with the potential to provide a preventive care model to reduce systemic inflammation and related chronic disease among WTC responders with PTSD.
Post-Traumatic Stress Disorder, Overweight and Obesity, Metabolic Syndrome, Inflammation
To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy
Inflammation, Cardiovascular Diseases, Zinc Deficiency
The purpose of this study is to better understand the underlying mechanisms associated with elevated cardiovascular disease risk in women with endometriosis, and to measure the effectiveness of emerging endometriosis treatments on outcomes specific to cardiovascular dysfunction. Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. The investigators hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is systemic inflammation and activation of LOX-1 receptor mechanisms.
Endometriosis