Clinical Research Directory

Salt-Sensitivity and Immunity Cell Activation

Salt-sensitive hypertension affects nearly 50% of the hypertensive and 25% of the normotensive population, and strong evidence indicates that reducing salt intake decreases blood pressure and cardiovascular events. The precise mechanisms of how dietary salt contributes to blood pressure elevation, renal injury, and cardiovascular disease remains unclear. Our data indicated that monocytes exhibit salt sensitivity, and the investigators hypothesize that of salt sensitivity of these and similar immune cells correlate with the hypertensive response to salt intake. Currently, the research tools for diagnosing salt-sensitivity are costly, time consuming and laborious. In this study the investigators will identify monocyte salt-sensitivity as a marker of salt-sensitive hypertension.

Fecal Microbiota Transplantation (FMT) to Slow Biological Aging

The goal of this clinical trial is to evaluate if multi-dose fecal microbiota transplantation (FMT) capsules can safely and effectively slow down biological aging and reduce chronic low-grade inflammation in adults aged 45 to 80 with metabolic neglect. The main questions it aims to answer are: * Can oral FMT capsules significantly slow the biological pace of aging as measured by the DunedinPACE epigenetic clock? * Can FMT successfully reduce chronic systemic inflammation (measured by markers such as suPAR, IL-6, and hs-CRP)? Researchers will compare participants receiving the active product to those receiving a matching placebo to see if the microbiome intervention improves metabolic health and cognitive function via the gut-brain axis. Participants will: * Undergo a short-term preparation phase involving targeted antibiotics and standard bowel cleansing. * Receive an 2 initial induction doses of active product (or placebo) followed by 5 regular booster cycles administered approximately every 4 weeks. * Attend periodic clinical visits for physical examinations, blood draws, stool sample collection (at home), and cognitive testing using the CANTAB platform and MoCA scale. * Maintain a participant diary to record adverse events (AE), product administration, stool sample collection, and dietary habits.

Effects of Taurine Supplementation and Morning or Evening High-intensity Exercise on Circadian Clock Genes and Inflammatory Parameters in Adult Women With Obesity

The goal of this clinical trial is to evaluate whether taurine supplementation, alone or combined with high-intensity interval training (HIIT) performed in morning or evening, affects circadian clock gene expression and inflamatory markers in adult women with obesity. The main questions it aims to answer are: * Is the modulation of circadian clock gene expression associated with the anti-inflammatory effects of taurine? * Does the timing of HIIT (morning or evening) affect circadian clock gene expression and inflammatory and metabolic responses? Researchers will compare six groups to evaluate the effects of taurine supplementation, HIIT performed in the morning or evening, and their combination. Participants will: * Take taurine (3g/day) or a matching placebo for 12 weeks, according to their assigned group; * Perform HIIT in the morning or evening if assigned to an exercise group; * Attend study visits at baseline (week 0) and after 12 weeks for assessments of metabolic and inflammatory parameters, circadian clock gene expression in peripheral blood mononuclear cells (PBMCs), as well as anthropometric measures, body composition and cardiorrespiratory fitness.

Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study

The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.

Effect of Bee Venom on T Regulatory Cells and Inflammation in Hemodialysis Patients: a Prospective Study Thesis

Chronic kidney disease (CKD) has emerged asa major cause of morbidity and mortality world-wide. Advanced CKD results in accelerated cardiovascular disease, cachexia,anemia, andnumerous other complicationswhich impair thequalityof life and shorten the life span in this population Our study aims to investigate the effect of Bee venom on T Regulatory Cells and inflammation in hemodialysis patients. This study will be carried out on (60) hemodialysis patients attending Urology and Nephrology center (Mansoura university). A prospective randomized control study. Patients will be devided in to two groups A. study group (20 patients) will receive bee venom. B. control group (40 patients): will not receive bee venom. All patients will be maintained on their regular medications eg: erythropoietin, iron, multivitamins, antihypertensive agents, and phosphate binders if needed.

Effects Of Periodontal Therapy In Patients With Inflammatory Bowel Disease

Periodontitis and inflammatory bowel disease have been associated by meta-epidemiologic evidence, although their mechanistic connection needs to be further explored. Oral-gut axis is implicated in the pathogenesis of several chronic inflammatory conditions, but to date no studies have evaluated the impact of periodontal treatment on gut ecology. Thus, the present observational prospective study is aimed at investigating the effect of conventional periodontal therapy on the gut microbiome and parameters of systemic inflammation of patients diagnosed with inflammatory bowel disease.

Diagnosis and Management of Inflammatory and Infectious Diseases

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.

Evaluation and Long-Term Follow-up of Patients With Inflammatory Disorders

This study will investigate inflammatory diseases and disorders. Inflammation is the body s immune response to many things, including infections and other acute or chronic irritants. It may also be a sign of abnormal immune function. This study will allow evaluation and long-term follow-up of such disorders to: * Establish and maintain a group of patients that may be eligible for other NIAID protocols. * Provide clinical training and experience for NIAID fellows. * Provide a mechanism for NIAID staff to maintain their clinical skills. * Serve as a starting point for new investigations of syndromes not currently under study. Patients between 1 and 80 years of age with acute or chronic inflammation, including but not limited to viral, fungal or bacterial infections, or abnormal immune responses may be eligible for this study. Immediate family members of patients may also be enrolled for preliminary examination to see if they are affected in any way that may warrant further investigation. All patients and family members will have a history, physical examination and laboratory tests. Depending on the results, family members may require additional tests. Patients will have additional diagnostic tests indicated for their specific disease, according to accepted medical standards. These may include routine blood and urine tests, X-rays or other imaging studies, body fluid or tissue cultures, skin tests for allergic or immune responses, and others as needed. Treatments will include only medications approved by the Food and Drug Administration according to accepted dose schedules and delivery methods. Patients may be requested to donate extra blood for research studies. No more than 450 cc (30 tablespoons) will be drawn from adults within a 6-week period, and no more that 7 cc (1/2 tablespoon) from children under 18 years of age in the same time period.

Natural History of the Human Biological Response to Environmental Exposure and Injury

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.

The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies

The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function. In Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim. In Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete: 1. rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.

Role of Inflammation in Vascular Phenotype Associated With E-cigarette Use

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.

The Psoriasis, Atherosclerosis, and Cardiometabolic Disease Initiative (PACI)

Background: \- Cardiometabolic diseases are medical disorders that can occur together and affect the heart. They increase the risk of developing heart disease and diabetes. One disorder, psoriasis, is an inflammation that mostly affects the skin but can affect the entire body. Another disorder, atherosclerosis, is a process in which cholesterol is gradually deposited on the wall of arteries. This causes arteries to harden and become less flexible. Many cells that cause psoriasis also cause atherosclerosis. Researchers want to look at the relationship between cardiometabolic diseases and psoriasis. Objectives: \- To study the relationship between psoriasis and cardiometabolic diseases. Eligibility: \- Individuals at least 18 years of age who have psoriasis. Design: * Participants will be screened with a physical exam and medical history. * Participants will have up to seven outpatient visits over the 4 years. The first visit will be a screening visit. Visits 2 will be12 months after visit 1. Visits 3, 4, and 5, will be scheduled yearly for the next 3 years. If participants have a psoriasis flare with more severe symptoms, they may have an extra visit. Those who leave the study early will have a final visit with the full series of tests. * At visits 1, 2,and 5, and any flare visits, participants will have a physical exam and medical history. They will provide blood and urine samples, as well as optional tissue biopsies. They will also have heart function tests. Imaging studies, as well as optional photographs of affected areas, will be performed. These tests will also be performed at the final visit. * At visits 3 and 4, participants will have a physical exam and medical history. They will also provide blood and urine samples, and have heart function tests.

A Comparison of Static and Dynamic PET/CT (HYPOTHESIS Generation Study)

The general purpose of this initial study is to evaluate whether parametric PET/CT improves diagnosis and treatment monitoring in select diseases. The specific aim of the HYPOTHESIS GENERATION study is: 1\. To obtain and compare parametric as well as traditional static PET/CT images and determine the number of lesions identified on each type of scan.

Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab

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.

The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.

This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with self-reported poor sleep.

Sleep and Inflammatory Resolution Pathway

Goal of this project is to investigate whether increases in inflammation that result from common patterns of restricting sleep on week nights and catching up on sleep over the weekend are caused by disruption in the newly discovered inflammatory resolution pathways. These pathways are crucial in the active termination of the inflammatory response, and their disruption may contribute to ongoing unresolved inflammation, which has been observed not only during periods of sleep restriction, but also after recovery sleep has been obtained. If the hypothesis is true, it is possible that increasing the body's natural production of endogenous, inflammatory resolution mediators may provide a non-behavioral strategy to limit the inflammatory consequences in those undergoing periods of sleep restriction with intermittent recovery sleep.

Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health

The goal of this study is to investigate inflammation as the biological mechanism by which mindfulness based cognitive therapy for perinatal depression (MBCT-PD) administered during pregnancy improves women's emotional well-being and whole person health index during pregnancy and the early postpartum period. Secondarily the investigative team will determine if MBCT-PD administered during pregnancy improves the physical health and emotional well-being of the developing child.

Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)

Glaucoma is the most common threat to vision rehabilitation in patients with Boston keratoprosthesis type 1 (KPro) implantation. High intraocular pressure (IOP) is the most important risk factor for glaucoma and may lead to irreversible retinal and optic nerve damage. Glaucoma drainage device (GDD) surgery is used to divert aqueous humor (AH) from the anterior chamber to an external reservoir to regulate flow and decrease the IOP. The AH is in direct communication with any corneal damage or surgery undertaken in the anterior chamber and can serve as a source of potential biomarkers to detect early inflammatory or glaucomatous changes. Tears are also one of the most accessible and non-invasive source of biomarkers, especially in Kpro eyes where the central optic allows communication between aqueous humor and the tears at the surface of the eye. The investigators propose to test the hypothesis that distinct inflammatory mediators in the AH and tears can serve as biomarkers for glaucoma development and progression after CT, making them specifically amenable to targeted treatment strategies to minimize vision loss.

Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women

Perinatal Mood and Anxiety Disorders (PMADs) encompass a range of mental health disorders that occur during pregnancy and up to one year postpartum. Approximately 13% of women experience PMADs. This rate doubles for those with adverse perinatal outcomes (APO) and triples in Black women. Recent research points to racism as one significant source of these health disparities. Cultural adaptations to improve communication with providers decrease rates of depression in minority patients as well as improve adherence to treatment, insight and alliance. Discrimination stress and worries about experiencing medical consequences are thought to increase systemic inflammation, a mechanism known to drive mental and physical symptoms. Inflammation has been implicated in both PMADs and APO, suggesting a shared underlying etiology. Evidence from our work suggests that inflammation contributes to the pathophysiology of PMADs. The proposed pilot randomized control trial will allow the investigators to build on promising preliminary results and identify whether our culturally relevant mobile Health (mHealth) intervention is effective in improving outcomes among Black pregnant women randomized to the intervention compared to a control group. The culturally relevant modules include building communication and self-advocacy skills and provide a support network. The primary objective of this research is to provide guidance for clinical care of Black women during the perinatal period, with the goal to improve mental health and physical health outcomes. A secondary goal is to examine novel inflammatory signatures that change as a function of the intervention to reduce PMADs in this population. As inflammation may be diagnostic of PMADs, identification of its role may shed light of potential intervention targets and provide critical knowledge to improve women's long-term health. PMAD symptoms will be assessed prospectively in 150 Black pregnant women, half of whom will be randomized to receive the culturally relevant mHealth intervention. The investigators hypothesize that women in the intervention group will have reduced rates of PMADs and APOs, an increase in adherence to mental health treatment and will report increased self-advocacy skills, increased communication with providers, and reduced levels of discrimination related stress. Participants will also have improved biological risk indicators including lower circulating C-reactive protein and a transcription profile of differentially expressed inflammatory genes, marked by a decreased activity of inflammatory transcription factors from blood spots. Given the high burden of both PMADs and APOs among Black mothers and the numerous consequences on maternal and child outcomes, it is imperative that investigators develop and implement effective interventions, and test the biological mechanisms that might drive these effects. This work is interdisciplinary, building on a network of community advocates to implement a novel mHealth intervention informed by real world experiences designed to enhance self-advocacy, reduce stress and prevent adverse outcomes

Preoperative Sleep Quality and Postoperative Outcomes in Breast Surgery

\* Brief Summary: This prospective, single-center observational study examined the association between preoperative sleep quality and postoperative outcomes in women undergoing elective breast cancer surgery. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), with scores ≤5 indicating good sleep quality and scores \>5 indicating poor sleep quality. The primary outcome was the systemic immune-inflammation index (SII), calculated from routine blood counts obtained 24 hours after surgery. Postoperative SII was compared between sleep-quality groups, accounting for preoperative SII and relevant clinical and surgical characteristics. Secondary outcomes included change in SII from baseline, pain intensity during the first 45 minutes in the post-anesthesia care unit (PACU), opioid consumption, rescue analgesic requirement, and length of hospital stay. Pain was assessed using a 10-cm visual analogue scale on PACU arrival and at 15, 30, and 45 minutes. Opioid consumption included morphine and tramadol administered during the final 20 minutes of surgery and the first 45 minutes in the PACU, expressed as intravenous morphine equivalents. No treatment was assigned by the study protocol. Anesthetic and analgesic management followed routine clinical practice.

Preeclampsia Research on Vitamin D, Inflammation, & Depression

This study is designed to comprehensively investigate the anti-inflammatory role of vitamin D in reproductive aged women, and its association with preeclampsia and depression. Findings will have substantial impact providing new information implicated in the development of preeclampsia (a condition that may include hypertension, tissue swelling caused by excessive fluid, and kidney stress) and postpartum depression (after birth). Additionally, the study is designed to understand how early mental health screening and evaluation can help pregnant women reduce their risk of developing postpartum depression. Testing the acceptability and effectiveness of this mental health screening, education and referral program at Cedars-Sinai Medical Center will provide valuable patient centered qualitative and quantitative data that can be used in future services planning. The study will enroll up to 200 pregnant women (in third trimester of pregnancy) in total.

CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy

This randomized controlled trial evaluates whether intraoperative guidance using the CoreSys monitor reduces the surgical stress response in patients undergoing elective open abdominal hysterectomy. Surgical stress involves complex hemodynamic, endocrine, and inflammatory responses that may negatively impact postoperative recovery. Patients will be randomized to either anesthesia guided by conventional clinical and hemodynamic parameters or anesthesia additionally guided by CoreSys-derived indices of consciousness, nociception, and stress activity. The primary objective is to assess whether CoreSys-guided anesthesia attenuates stress biomarkers, including interleukin-6 (IL-6), cortisol and glycemia.

Blood Markers of Inflammation, Blood Clotting and Blood Vessel Function in HIV-infected Adults

This study will collect information about markers of inflammation, blood clotting and blood vessel function in HIV-infected adults and healthy volunteers. Biomarkers are biological indicators that have been associated with disease. Certain markers of inflammation, blood clotting, and blood vessel function have been associated with risk of cardiovascular disease, stroke and death. One marker, called D-dimer, is a breakdown product of blood clots that has been associated with serious medical conditions, including deep vein thrombosis (formation of a blood clot in a vein deep in the body) and pulmonary embolism (blockage in the pulmonary artery that occurs when a blood clot from a vein breaks away, travels to the pulmonary artery and lodges there). High D-dimer levels have also been associated with cardiovascular disease and stroke risk. In a recent study of HIV-infected patients, higher D-dimer levels were strongly correlated with risk of death from any cause. The significance of changes in D-dimer and other biomarkers in HIV-infected adults is not well understood. This study will further explore D-dimer and other biomarkers to try to better understand the relationships between them and HIV infection. Healthy volunteers and HIV-infected adults 18 years of age or older may be eligible for this study. Two visits are involved, as follows: Visit 1 (screening visit to determine eligibility) * Medical history and physical examination. * Blood tests for HIV infection, blood counts, liver and kidney function. * Pregnancy test for women who can become pregnant. Visit 2 * Blood tests for hepatitis B and C * Blood tests for markers of inflammation and blood clotting. * Blood test for genetic changes that influence blood clotting. In some cases, visits 1 and 2 may be combined. Optional additional visits (up to 8 visits over 3 years) * Additional blood draws for investigation of specific clinical or laboratory findings may be requested.

Vascular Inflammation in Atherosclerosis - Whole Body Molecular PET/CT Imaging Using Folate Receptor β

This study investigates inflammation in the blood vessels of people with coronary artery disease (CAD) or a recent myocardial infarction. Inflammation plays an important role in the development and progression of atherosclerosis, but there is currently no established clinical imaging method for detecting inflammation in atherosclerotic plaques throughout the body. The study uses a new PET imaging tracer called 18F-AlF-NOTA-Folate. The tracer is designed to bind to folate receptor beta (FR-β), a marker found on activated macrophages, which are immune cells involved in inflammation. The aim is to determine whether PET imaging with this tracer can detect and measure inflammation in atherosclerotic plaques. Approximately 90 patients will participate. One group will include patients with suspected or stable coronary artery disease who are undergoing coronary CT angiography and PET imaging as part of their clinical assessment. A second, smaller group will include patients who have recently had a myocardial infarction. Participants will undergo PET and CT imaging and provide blood samples. The imaging will examine the coronary arteries and other major arteries, including the carotid arteries, aorta and iliac arteries. The study will also investigate blood flow in the heart and other organs and examine the relationship between vascular inflammation, atherosclerotic plaque characteristics and markers of inflammation in the blood. The study is not testing a treatment for coronary artery disease. The folate tracer is administered only for imaging purposes. Participants will be followed through hospital and registry records for up to five years to investigate whether imaging findings are associated with later cardiovascular events. The study may provide new information about how inflammation is distributed in atherosclerosis and whether FR-β-targeted PET imaging could be useful for detecting and studying vascular inflammation in patients with cardiovascular disease.