Inflammation Clinical Trials

Background: About 40 percent of adults and 20 percent of adolescents in the U.S. have a body mass index over 30 kg/m2. Being overweight may lead to a state of low-level inflammation. This may cause health problems. Researchers want to see if an anti-inflammatory medicine can help. Objective: To learn if colchicine can improve metabolism in people who have high body weight, increased inflammation, and high insulin in the blood but who have not yet developed high blood sugar. Eligibility: People aged 12 and older with high body weight who may have increased inflammation and high insulin in the blood. Healthy adult volunteers are also needed. Design: Participants will be screened with the following: Medical history Physical exam Fasting blood tests Urine tests Electrocardiogram Dual energy x-ray absorptiometry (They will lie on a table while a camera passes over their body.) Stool sample and 24-hour food diary (optional) Participants will have 3 study visits and 3 phone check-ins. At visits, they will repeat some screening tests. Healthy volunteers will have the baseline visit only. They will not get the study drug. At the baseline visit, participants will have an Oral Glucose Tolerance Test (OGTT). For this, they will drink a sweet liquid and then give blood samples. They will get a 12-week supply of the study drug or placebo to take daily by mouth. Participants will have study visits 6 weeks and 12 weeks after they started taking the study drug. At the 12-week visit, they will repeat the OGTT. Participation will last for 3 (Omega) to 4 months. ... Read Less

Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), can increase self-grown stem cells naturally. Study Design This is a randomized, double-blinded, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in impacting stem cells. Approximately 46 volunteers who want to increase self-grown stem cells will participate in the study. Study Randomization The biostatistician will prepare a randomization schedule including a serial of subject numbers. A subject number will be randomly assigned to each study participant, which will assign them to either the control group or the treatment group. Other than the Informed Consent Form (ICF), all study information will be recorded by using the subject number. The Principal Investigator, study physicians, study nurse, data-entry specialists, and biostatisticians, as well as the participants, will be blinded about who received which product during the first two weeks of study participation. Read Less

Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. states are poised to increase production if consumer demand increases. A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts. Additionally, little is known about which Haskap varieties and harvest timing yield the greatest bioactive potential. This study aims to address these gaps by investigating the interaction of bioactive components in Haskap with gut microbiota and the resultant gut and serum metabolites, inflammation, and metabolic health, and then couple this with analysis of berries from different Haskap varieties and harvest times. Read Less

Background: Environmental exposures like pollution, diet, and stress can help cause human diseases, or make them worse. Researchers want to better understand how injury and inflammation are caused by these exposures. They want to collect biological and environmental samples and other data. They may use the samples to measure a range of factors, like hormones, toxins, and chemicals. This will help them improve their studies. Objective: To identify and understand how environmental exposures contribute to human disease. Eligibility: Healthy adults ages 18 and older Design: Participants will be screened with questions about their health history, demographics, and medicines they take. Participants may give blood, hair, stool, saliva, and/or urine samples. They may have a skin punch biopsy to collect skin cells. They may give fingernail or toenail clippings. They may give a sample of exhaled breath. Participants may give a sputum sample. They will inhale a saline mist and cough mucus into a cup. Participants may have their nasal passages brushed, scraped, or washed. Participants may give cheek cell samples. They will swish mouthwash and spit it into a cup. Participants who produce sperm may give samples. Participants may have bronchoscopy to collect fluid. A saline solution will be put into their lung and then suctioned out, washing areas of the lung. Participants may have a pelvic or transvaginal ultrasound. They may have lung function tests. Participants may collect household dust, urine, or stool at home. Participants will complete surveys about their health, diet, and exposures. Participation will last for one or more study visits. Participants may be contacted in the future to take part in other studies. Read Less

The research aims to understand how a specific type of medication called Sodium-glucose co-transporter 2 (SGLT2) inhibitors affect cardiorenal inflammation. Read Less

This study will investigate the response of immune cells (neutrophils, monocytes) to various signals in the test tube to determine how they sense the signals in the body and what substances they produce in response to them. It will determine how the cells may, under certain circumstances, contribute to inflammation, and will measure substances in the blood plasma (the liquid, non-cellular part of the blood) that might stimulate white blood cells, in order to understand how the blood responds to possible disease-related conditions. Healthy normal volunteers 18 years of age and older who weigh at least 110 pounds may be eligible for this study. Participants give about 320 milliliters (mL) of blood (about 1 1/3 cups) or less at each donation. They donate no more than once every 8 weeks and no more than six times a year. On some occasions, less than 320 mL of blood may be drawn. The collected blood is separated into its components and specific cells are exposed to substances to examine their response. Read Less

The goal of this clinical trial is to learn if Nicotinamide adenine dinucleotide (NAD+) can influence cognition and biomarkers in healthy, cognitively intact women who identify as Latina and are between the ages of 40-80. The main questions it aims to answer are: Will executive function change in response to NAD+? Will inflammatory markers and serum indicators of neurodegeneration change in response to NAD+? Researchers will compare individuals receiving the NAD+ to see if the results differ from those receiving the placebo. Participants will: Complete an online questionnaire, Visit the lab for computerized cognitive testing and a blood draw, Take NAD+ or a placebo every day for 4 weeks, Visit the lab for computerized cognitive testing and a blood draw Read Less

This protocol is being established to cover the evaluation of patients with inflammatory and/or infectious diseases which are not covered under previously existing protocols. The purpose of such a protocol is that frequently patients are referred to us with either diagnosed or undiagnosed illnesses which would be of interest to our teaching program or which would serve as a source of patients to subsequently be entered into established, ongoing protocol studies. Such patients will be admitted to the protocol and handled according to accepted medical practice of diagnosis and treatment. Read Less

The plot study aims to evaluate the effect of 8 weeks of stress reducing intervention on atherosclerotic plaque inflammation in adults, as quantified by positron emission tomography (PET) with fluorine-2-deoxy-D-glucose (FDG) in individuals with increased psychosocial stress. Read Less

The goal of this clinical trial is to test the effectiveness of a Smart Bassinet to prevent/mitigate postpartum mood disorders by augmenting maternal sleep and/or enhancing infant sleep. The investigators will conduct a 2-arm randomized controlled trial (RCT) to compare infant and maternal sleep of infants who use a smart bassinet (SB) or a standard commercially available bassinet (Halo Bassinest Swivel Sleeper 3.0) (usual/traditional care (TAU)). After confirmation of eligibility, participants (N = 342) will randomly be assigned to either the SB or TAU. The investigators hypothesize that use of the SB will be associated with better infant and maternal sleep over a 6-month period, and these mothers will report fewer depressive and anxiety symptoms across the postpartum. The main question\[s\] it aims to answer \[is/are\]: Aim 1: Determine the effect of the SB on infant sleep and maternal sleep. \[primary hypothesis or outcome measure 2\]? Aim 2: Determine the effect of the SB on maternal postpartum depressive symptoms and evaluate the model that the association between the SB and postpartum depressive symptoms is mediated by both infant and maternal sleep Aim 3: Compare trajectory of immune system function from late pregnancy through postpartum between PPD and non-PPD and between SB and TAU groups Exploratory Aim. Evaluate whether the elevated risk demonstrated by previously identified PPD epigenetic biomarkers at the TTC9B and HP1BP3 genes can be modified by using a SB. The investigators hypothesize that the elevated risk will be reduced in the SB condition compared to TAU. Military-affiliated pregnant women will be recruited from across the US via social media and advertising. Monthly online questionnaires will be completed by the mother. Objective sleep data will be collected monthly using an actigraph for 1-week from both mother and baby. Blood samples for assay of inflammatory markers will be collected at enrollment, 3- and 6- months postpartum. Read Less

This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women. Read Less

The purpose of this randomized controlled trial is to understand how a cognitive-behavioral treatment (a form of psychological treatment) for depression changes the gut microbiome (micro-organisms that regulate the health of the gut), immune system, and the brain functioning in people living with HIV. Read Less