Clinical Research Directory

Analysis of Inflammatory Biomarker Changes in Dry Blood Spot Versus Venous Blood Samples

The purpose of this study is to see whether dried blood spot (DBS) samples can measure inflammatory biomarkers as accurately as venous blood samples. Investigators will be measuring inflammatory biomarkers changes obtained in DBS compared with paired venous blood samples following a controlled physiological stressor (i.e. after a vaccine or other planned event that can cause a temporary rise in inflammation). These findings will help understand whether DBS can be a reliable alternative to traditional blood draws in future research and healthcare.

Berberine Supplementation, Sprint Interval Training, and Immune Function Study

The purpose of this clinical trial is to investigate the effects of a 2-week intervention involving berberine supplementation or sprint training in isolation as well as berberine combined with sprint training on well-being, anaerobic power, and monocyte number and function in individuals experiencing mild mental health challenges. The main questions it aims to answer are: * Does short-term berberine use or sprint training improve measures of mental health, psychological wellbeing, fatigue, and sleep quality? * Does short-term berberine use or sprint training improve measures of anaerobic power generation? * Does short-term berberine use or sprint training improve circulating biomarkers of inflammation? * Does short-term berberine use or sprint training improve monocyte number, function, and cytokine production?

Expanded Studies on the SCAPIS Stockholm Reexamination Cohort

The Swedish CArdioPulmonary bioImage Study (SCAPIS) is a unique, large-scale national research initiative involving 30,000 randomly selected individuals aged 50-64, recruited between 2014 and 2018. The study is a collaborative effort among six university hospitals across Sweden. A follow-up study, SCAPIS 2, is conducted for half of the original participants. In Stockholm, 2,500 individuals will be re-examined at Danderyd University Hospital and Karolinska Institutet. SCAPIS 2 includes a core set of examinations involving blood sampling, questionnaires, and imaging. In addition to these, complementary local investigations are conducted to enable more detailed research questions. This protocol describes the additional studies conducted in the Stockholm cohort. All complementary assessments aim to identify risk factors for current and future lung, liver, and cardiovascular diseases.: EXTENDED SAMPLING: Saliva and Blood Samples with Blood Cell Isolation. EXTENDED QUESTIONNAIRES: Dyspnea, Sleep, Respiratory Infections, and Dental Health. EXTENDED IMAGING AND PHYSIOLOGICAL MEASUREMENTS Cardiac Ultrasound and Abdominal Aortic Measurements. Liver Elastography. Vascular Stiffness by cuff-based pulse wave analysis and Photoplethysmography (PPG). Valvular and Vascular Calcification by CT imaging.

Effect of Ginger Capsules on Inflammation, Oxidative Stress, and Endothelial Function

Randomized, double-blind, parallel, placebo-controlled clinical trial designed and conducted to evaluate the effect of daily consumption of ginger, on parameters related to inflammation, oxidative stress, and endothelial damage in adults with excess adiposity.

Breastmilk and the Link to Overweight/Obesity and Maternal Diet in the Mother-breastmilk-child Triad

The prospective 5-month follow-up study will involve 150 mother-infant dyads grouped based on maternal baseline BMI category (normal weight, overweight, obesity). The investigators plan 3 study visits (1, 3, and 6 months postpartum) with analysis the following parameters and outcomes: 1. maternal anthropometry and body composition; 2. maternal dietary intake and dietary patterns (with results of biomarker-based validation); 3. maternal status of lipophilic antioxidants, selected vitamins, and fatty acids profile that may be related to adipose tissue metabolism, inflammation, and cardiometabolic status; 4. maternal metabolomics, adipokines, insulin, selected biomarkers of inflammation, altered glucose metabolism, and oxidation; 5. breastmilk composition assessed by systemic approach (macronutrients, fatty acids profile, lipophilic antioxidants, adipokines, hormones, immunological profile, and preliminary lipidomic analysis in part of the study group); 6. infant growth trajectory, body composition, urine metabolomics, and biomarkers of oxidative stress. Additionally, maternal and infant stool, buccal swabs, and human milk samples will be banked for further microbiome analysis studies.

Effect of a Ginger-Based Beverage on Inflammation, Oxidative Stress, and Endothelial Function

Randomized, double-blind, parallel, placebo-controlled clinical trial designed and conducted to evaluate the effect of daily consumption of ginger, on parameters related to inflammation, oxidative stress, and endothelial damage in adults with excess adiposity.

Resveratrol Effects on Inflammatory Biomarkers and Cardiometabolic Parameters.

This study aims to evaluate the effect of the supplementation of grape pomace bars enriched in resveratrol on inflammatory biomarkers and cardiometabolic parameters in community-dwelling adults

Macrophage/Monocyte Driven Inflammation and Anesthetic Sensitivity in Aging

The goal of this observational study is to determine whether macrophage/monocyte mediated inflammatory signaling contributes to reduced anesthetic requirements in older adults undergoing major abdominal surgery. The main questions it aims to answer are: * Is there a difference in anesthetic dosing requirements (minimum effective dose) between young and older patients undergoing major abdominal surgery? * How do electroencephalographic (EEG) signatures under anesthesia correlate with age and systemic inflammatory markers? * Is there an association between age, levels of circulating inflammatory cytokines, and monocyte/macrophage phenotypes with anesthetic requirements? If there is a comparison group: Researchers will compare older adult patients undergoing major abdominal surgery to younger adult patients undergoing major abdominal surgery to see if macrophage/monocyte-mediated inflammatory signaling influences anesthetic sensitivity and the risk of postoperative neurocognitive complications in the older population. Participants will: * Receive general anesthesia for major abdominal surgery, with continuous recording of anesthetic dose requirements. * Undergo electroencephalographic (EEG) monitoring during the anesthetic period. * Provide blood samples for the measurement of circulating inflammatory cytokines and the assessment of monocyte phenotypes. * Provide peritoneal tissue samples (collected during surgery) to evaluate tissue macrophage populations. * Provide cerebrospinal fluid (CSF) samples to assess biomarkers of blood-brain barrier permeability.

Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function

The goal of this observational study is to determine whether changes in the inflammatory profile of heart failure patients can help identify those who may have a worse prognosis or who might benefit more from specific treatments. In addition, we aim to explore whether certain genes or gene mutations are related to a higher risk of future cardiovascular problems. Heart failure continues to be a major cause of hospital admissions and death in our society. Because of this, it is very important for healthcare professionals to identify which patients are at higher risk of complications, so that we can provide the best possible treatment and follow-up. One method we use to help predict how the disease may evolve is the study of biomarkers, which are measurable biological substances that can help detect, monitor, or treat illnesses in a more personalized way. In this study, the investigators will measure mainly inflammatory biomarkers that will be analyzed from a blood sample taken during hospital stay after being diagnosed with heart failure with preserved or mildly reduced ejection fraction. Any important health events that happen during the next six months after patients are discharged from hospital will also be recorded. In addition, it is known that more than 2,000 diseases are known to be caused by changes in specific genes. In the case of cardiomyopathies-heart muscle diseases that can lead to heart failure-genetic causes vary depending on the type, and studies suggest that between 10% and 50% of cases may have a genetic origin. Identifying genetic markers linked to heart failure with preserved or mildly reduced ejection fraction may help improve prevention, treatment, and risk assessment, as some genetic changes may be associated with repeated cardiovascular events. By studying not only circulating biomarkers but also genetic factors, the investigators hope to better understand whether certain gene alterations may increase a person's tendency to experience additional heart-related events. This is an observational study, which means that medical care and treatment will be exactly the same whether patients choose to participate or not. Participation involves allowing researchers to collect relevant information from medical records and agreeing to the collection of two or three small additional blood samples for research purposes. These samples will be used to measure the biomarkers and to analyze genes in the white blood cell fraction obtained from the same tubes.

Studies on Adsorption International Learning Initiative Global

Use of sorption technologies in patients undergoing maintenance hemodialysis with inflammatory syndrome and clinical manifestations of uremia

Neuro-Inflammation in Extremity Trauma: Risk Verification in Elbow Trauma: The NERVE Study

The primary goal of this proposal is to improve the understanding of the mechanisms causing persistent pain and disability in elbow fracture patients and their associated functional limitations. The specific objectives are as follows for elbow fractures: 1\) To describe NI mechanisms using biomarkers; 2) To identify factors related to increased NI biomarkers level; 3) To describe the associations between NI and outcomes; 4) To use these findings to refine a larger fully powered prognostic cohort study Hypotheses 1. Level of neuro-inflammation (NI) biomarkers\* will be significantly higher in patients presenting with both elbow fracture and CNS injury or PNI. 2. Consumption of opioid in mg of morphine equivalent will be higher in patients with a higher level of NI biomarkers. 3. Function, assessed by validated joint and limb specific functional questionnaires and QoL will be worse in patients with a higher level of NI biomarkers. 4. Chronic pain at 3 months will be higher (McGill Pain questionnaire V2, Neuropathic pain questionnaire, NPRS) in patients with a higher level of NI biomarkers. 5. Duration of tourniquet use and nerve dissection will be correlated to elbow fracture outcome with a higher level of NI biomarkers. * Target biomarkers based on preliminary study will include, but not be limited to: TNFa, IL6, Substance P, IL-1B, TREM-2, IL-16, CCL22, VEGF-a, BMPs (table 1).

Feasibility and Potential Efficacy of Herbs and Spices for Improving Dietary Quality in College Students: A Pilot Study

The goal of this single-arm feasibility, pilot study is to assess the feasibility, acceptability, and potential effectiveness of the Herbs and Spices Nutrition Education Program (HSNP-focusing on incorporating herbs and spices into the diet for adherence to the DGA's) for determining the scalability of implementing this intervention for a larger scale, more comprehensive study The main questions it aims to answer are: * What is the feasibility and acceptability of incorporating herbs and spices into the diet along with DGA-focused nutrition education through the HSNP in college students with poor dietary quality? * What are the preliminary effects of the HSNP on dietary intake/quality, cardiometabolic, and gut health in college students with poor dietary quality? * What are the barriers associated with HSNP implementation in college students with poor dietary quality? Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the clinical study site for a Pre-HSNP and Post-HSNP Study Visit (one week prior starting the HSNP and after week 6 of completing the HSNP) for assessments of cardiometabolic and gut health. * Be asked to come to the Nutrition Center for weeks 0 and 3 of the HSNP, where they will receive education on the Dietary Guidelines for Americans and the health benefits of herbs and spices, have a sensory evaluation of foods, be provided budget-friendly recipes and resources, and given take-home herbs, spices, and supporting materials * Be asked to complete 3-Day Food Records throughout the 6 week study period for assessment of dietary quality (4 total)

How a Mediterranean Diet With Potatoes Impacts Heart and Metabolic Health in Adults With Pre-Diabetes

The goal of this clinical trial is to is to determine the effects of baked potato with the skin (BP) + nutrition education focused on adherence for a Mediterranean Dietary Pattern (MEDNE) on glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. The main questions it aims to answer are: * Does BP+MEDNE contribute to improvements in indices of glycemic control, vascular function, blood lipids, inflammation/oxidative stress, and body composition? * Does BP+MEDNE contribute to improvements to overall dietary intake and quality? Researchers will compare BP+MEDNE to MEDNE alone to see if BP+MEDNE can improve glycemic control, cardiometabolic health, and dietary quality in individuals with pre-diabetes from different demographic backgrounds. Participants will: * Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility. * Be asked to come the study site for a Pre-Baseline and Pre-12-Week Study Visit (one week prior to Baseline and 12-Week Study Visits) for placement of placement of a continuous glucose monitor and wearable devices to be removed at Baseline and 12-Week Study Visits. * Be asked to come to the study site for Baseline, 6- and 12-Week Study Visits for assessments of glycemic control and cardiometabolic health. * Be asked to complete 3-Day Food Records throughout the 12 week study period for assessment of dietary quality (5 total) * Receive pre-recorded MEDNE ( which can be accessed via computer device/ipad/smartphone) after Baseline and 6-Week Study Visits. * If randomized to the BP+MEDNE group, participants will receive pre-prepared baked potatoes with the skin for the 12-week study period (every 3 weeks) at Baseline and 6-Week Study Visits and asked to come to the study site for picking up the pre-prepared baked potatoes at weeks 3 and 9 of the study period.

Dietary Wild Blueberries and Joint Health

The goal of this proposed study is to examine the effects of dietary wild blueberries on gut microbiome, serum markers of inflammation, and joint function in adults. Each participant will consume 25g freeze-dried blueberries or matched placebo powder for 12 weeks, with a 2-week washout phase between.

TIRANA-ACS: A Prospective Registry Study for the Targeted Investigation of Residual Inflammation After Non-ST/ ST Elevation Acute Coronary Syndrome

This prospective observational study aims to evaluate the prognostic significance of the neutrophil-to-lymphocyte ratio (NLR) as a predictor of mortality in patients following an episode of Acute Coronary Syndrome (ACS). Despite advancements in interventional cardiology and medical therapy, mortality remains significant in post-ACS patients, and early risk stratification is essential for optimizing outcomes. Recent studies have suggested that systemic inflammatory markers, such as NLR, are associated with adverse cardiovascular events. It is an easily obtainable and cost-effective laboratory parameter derived from a routine complete blood count. However, its value as an independent predictor of mortality post-ACS has not yet been fully established in our population. The study will include patients aged, admitted with a confirmed diagnosis of ACS (STEMI or Non-STEMI) and treated with percutaneous coronary intervention (PCI). NLR values will be measured from the first blood draw upon hospital admission, 24 and 48 hours post PCI. Patients will be followed up for up to 6 months after discharge through telephone interviews . First, primary outcomes of the study will be the association between NLR values and mortality (all cause mortality and cardiovascular mortality), MACE (MACE was defined as the composite of all-cause mortality, cardiac death, unplanned revascularization, non-fatal myocardial infarction that was attributable and not related to stent failure or unplanned revascularization not related to stent failure) within 6 months post-ACS. Secondary outcomes will include: 1. Differences in mean NLR between STEMI and NSTEMI patients. 2. Association between elevated NLR and the presence of multivessel coronary artery disease on angiography. 3. Correlation of NLR with other biomarkers, including the platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), high-density lipoprotein (HDL) cholesterol, and maximum troponin levels (as an indicator of myocardial infarction size) This study aims to contribute to the identification of easily accessible and cost-efficient biomarkers that can aid clinicians in early risk stratification of ACS survivors. A strong correlation between high NLR values and increased post-discharge mortality would suggest that inflammation plays a key role in patient prognosis and could potentially influence post-ACS management strategies.

Evaluation of Systemic Inflammatory Index and Biomarkers in Relation to Inferior Alveolar Nerve Block Success and Postoperative Pain

This study aims to investigate the relationship between systemic inflammatory markers and the effectiveness of inferior alveolar nerve block anesthesia in patients undergoing dental treatment. The primary focus is on the Systemic Inflammatory Index (SII) and other inflammatory biomarkers, and how they may influence both the success of anesthesia and the intensity of postoperative pain. By analyzing blood samples and clinical outcomes, the study will provide new insights into the role of systemic inflammation in anesthesia effectiveness and postoperative pain control. The findings may help clinicians predict anesthetic success and improve pain management strategies in dental practice.

Effects of Adjunct Omega-3 Long Chain Polyunsaturated Fatty Acids in Pulmonary Tuberculosis Patient: an Early Bactericidal Activity and Inflammatory Trial

The goal of this randomized controlled trial is to evaluate the early bactericidal activity, early inflammatory response, and safety of omega-3 long chain polyunsaturated fatty acid (n-3 PUFA) supplementation in adult patients (aged 18- 45 years) with newly diagnosed, bacteriologically confirmed drug-sensitive pulmonary tuberculosis. The main questions it aims to answers are: * Does adjunct n-3 LCPUFA supplementation reduce the sputum culture time to positivity * Does it improve inflammatory markers and TB treatment outcomes compared to placebo Researchers will compare daily supplementation with \~2g n-3 LCPUFA (EPA and DHA ) to placebo (high linoleic sunflower oil) to determine effects on bactericidal activity, inflammation, and clinical outcomes. Participants will: * Be randomly assigned to receive either n-3 LCPUFA or Placebo daily for 8 weeks with the intensive phase of TB treatment * Attend clinical visit baseline, and follow up visit mostly weekly for 2 months and then monthly for 4 months of the continuous phase of TB treatment * Provide blood, sputum and urine samples for biomarkers and metabolomic analysis * Undergo assessments of iron status, body composition and muscle strength

Effect of Vitamin D on Inflammatory Markers in Type 2 Diabetes Mellitus in Mexico.

Type 2 Diabetes Mellitus (T2DM) is a very common disease in Mexico, and its long-term complications affect years of healthy life and a high cost in treatmenty. T2DM is a chronic disease associated to inflammation. We aim to establish if Vitamin D may help decrease this inflammation and improve the condition in adults with T2DM. Patients included in the study will have to take 1 pill/day of vitamin D for six months. The investigators will measure weight, height, waist and hip circumference, systolic and dyastolic blood pressure; obtain dietary and clinical information, as well as a 10mL blood sample from the arm, for laboratory analyses, finger-prick blood sample for glucose at the beginning and end of the study; ´plus a finger-prick blood samplo for the initial vitamin D status. The study is completely free for the participants and they may withdraw their consent at any time without any consequences. Participants will have to attend the clinic at the beginning and every two months until the end, to receive their supplement (total 4 appointments). They will receive a phone call once a week to remind you to take your pills. They will be handed your results at the end of the study.

Efficacy of Satisens® in Reducing Emotional Eating

This study evaluates the efficacy of Satisens®, a dietary supplement composed of plant extracts, in reducing emotional eating and sweet cravings in healthy adults. The study will analyze hormonal, neurotransmitter, and inflammatory markers to understand the underlying mechanisms.

Effect of Walnuts on Cognitive Function and Gut Microbiome in Older Adults

The purpose of this study is to examine the impact of daily consumption of walnuts for 12 weeks on cognitive function, markers of inflammation and oxidative stress, and the gut microbiome in healthy adults age 55 years and older.

Postprandial Effect of Olive Leaf Biscuits and Tea Consumption on Blood Biomarkers in Healthy Individuals

This randomized controlled nutritional intervention study aims to investigate the bioactivity of dried olive leaves in biscuit and tea preparations, focusing on their postprandial effects on selected biomarkers and plasma antioxidant status. Healthy volunteers aged 18 to 65 from Limnos, Greece, will participate in the study, held at the Human Nutrition Unit of the University of the Aegean. The study will last 15 days and features a cross-over design involving three groups: Control Group: Consumes biscuits made with butter, flour, sugar, and caramel coloring, along with natural mineral water. Intervention Group A: Receives the same biscuits with added dried olive leaf powder, accompanied by the same water. Intervention Group B: Eats the standard biscuits with olive leaf tea instead of water. On each study day, participants will consume their meal over 15 minutes, followed by the liquid within 10 minutes. After a 7-day washout period, the groups will switch treatments for the second phase. The procedure will be repeated on the 15th day, ensuring that all participants experience each condition. Blood samples will be collected before and at 60, 120, and 240 minutes post-meal for analysis. Statistical processing will then be conducted to evaluate the effects on biomarkers and antioxidant status.

The Effect of Ketogenic-caloric Restricted Diet on Metabolic Endotoxemia in Prediabetic Obese Adults

Insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. Metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (LPS), disrupts insulin signaling via inflammatory pathways. While dietary interventions may lower LPS levels and improve insulin resistance, evidence on the effectiveness of ketogenic diet in this context remains limited. This randomized controlled trial aims to assess the effects of a ketogenic-caloric restricted diet on metabolic endotoxemia, measured by serum LPS levels, in prediabetic obese Jordanian adults aged 18-40 years in Amman over 12 weeks. Ninety participants will be randomly assigned to one of three groups (n=30 each): a ketogenic-caloric restricted diet, a normal-fat caloric restricted diet, or a control group (normal-fat without caloric restriction). Anthropometric parameters and dietary intake will be evaluated at baseline, week 6, and week 12. Blood samples will be collected at baseline and week 12 for measuring fasting glucose, insulin, LPS, inflammatory cytokines. Dietary adherence will be monitored through food records. This study aims to provide new insights into the role of dietary interventions in modifying metabolic endotoxemia and improving insulin resistance.

The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old

Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and pro-inflammatory biomarkers among prediabetic obese Jordanian adults aged 18-40 years. The study assesses changes in pro-inflammatory biomarkers (IL-1β, TNF-α, IL-6), insulin resistance (HOMA-IR), and body composition over 12 weeks. Participants (n=120) will be randomized into four intervention arms: (1) TRE with CR, (2) TRE without CR, (3) CR without TRE, and (4) a control group with no dietary restrictions and no TRE. Biweekly anthropometric assessments will evaluate pro-inflammatory biomarkers and biochemical measures at baseline and the end of the study. The findings will provide insights into the comparative effectiveness of TRE and CR, potentially offering a safe, cost-effective intervention to prevent obesity-induced inflammation, prediabetes, and progression to type 2 diabetes mellitus.

Comparison of Inflammatory Factors, Pain Scale, and Postoperative Recovery Quality (QOR - 15) in Patients Undergoing Colorectal Cancer Surgery with Conventional General Anesthesia Techniques Compared to General Anesthesia Combined with Epidural Anesthesia At Prof. Ngoerah Hospital

Surgery can increase IL-6 cytokines, triggering inflammation and metastasis. The combination of general and epidural anesthesia has the potential to suppress IL-6, improve the tumor microenvironment, provide analgesia, and enhance postoperative recovery. Objectives :To compare the effectiveness of postoperative analgesia quality in colorectal cancer patients receiving general anesthesia combined with epidural anesthesia.