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Inflammation clinical trials

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NCT ID: NCT06242535 Recruiting - Obesity Clinical Trials

Pilot Study of GLY-LOW Supplementation in Postmenopausal Women With Obesity

Start date: July 27, 2023
Phase: Early Phase 1
Study type: Interventional

A combination of generally regarded as safe (GRAS) compounds named GLY-LOW, which included: alpha lipoic acid, pyridoxamine, nicotinamide, piperine and thiamine, were examined in pre-clinical experiments. GLY-LOW supplementation reduced caloric intake and increased insulin sensitivity in mice. In female mice, GLY-LOW supplementation reversed aging-related declines in female hormones. Studies in humans are needed to examine the feasibility, utility and efficacy of GLY-LOW supplementation in post-menopausal women with obesity toward improving aging-related impairments. The effect of GLY-LOW supplementation on these obesity and biological age-related impairments in post-menopausal adult female humans with obesity is unknown. We aim to translate the findings of GLY-LOW supplementation in animals to a cohort of healthy, postmenopausal females at birth with obesity by conducting a one-group, no-placebo comparer, pre post intervention clinical trial. Additionally, we propose to examine the specific effect of supplementation by GLY-LOW on biological aging via retina scan. The objectives of the proposed pilot study are: I. Conduct a 6-month pilot study to examine the feasibility, utility and efficacy of GLY-LOW supplementation in a total of 40 postmenopausal female born adults > 55 years with obesity (> 30 BMI) Ia. Examine alterations in self-reported caloric intake and the following health and biological aging, parameters prior to and after 6 months of GLY-LOW supplementation: 1. Self-reported Caloric Intake 2. Metabolic disease risk 3. Cardiovascular disease risk 4. Metabolic assessments 5. Hormones 6. Physical Function and Fitness 7. Muscular strength 8. Cognitive Function and Depression assessments 9. Systemic inflammation 10. Biological aging 11. Safety parameters (also every 2 months during the intervention; ECG at baseline and 2 months only) 12, Compliance measures (pill counts and interviews every 2 months during the intervention)

NCT ID: NCT06241742 Recruiting - Pain Clinical Trials

Evaluating Ability of HT-6184 to Reduce Inflammation and Pain After Third Molar Extraction

Start date: February 2024
Phase: Phase 2
Study type: Interventional

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

NCT ID: NCT06238986 Recruiting - Clinical trials for Anatomic Stage III Breast Cancer AJCC v8

Relationship Between Alterations in the GI Microbiome and GI Inflammation on Symptom Burden in Women With Breast Cancer Receiving Chemotherapy

Start date: March 22, 2024
Phase:
Study type: Observational

This study evaluates the relationship between alterations in the GI microbiome and GI inflammation on symptom burden in women with breast cancer receiving chemotherapy.

NCT ID: NCT06235021 Recruiting - Clinical trials for Periodontal Diseases

Clinical Efficacy of Saffron Mouth Rinse in Periodontitis Patients With Renal Disease

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The commensal oral bacteria are responsible for the initiation and propagation of the disease through the process of dysbiosis, or microbial imbalance. The disease proceeds cyclically with periods of activity and quiescence until therapeutic action is taken, or the tooth and surrounding structures are destroyed by the disease process that may result in the loss of the tooth. As periodontal disease progresses from gingivitis to periodontitis, a greater number of anaerobic organisms colonize deeper periodontal pockets, such as Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis, which triggers the host inflammatory response. This response includes the production and dissemination of C-reactive protein (CRP), a biomarker of inflammation, as well as various neutrophil and macrophage compounds such as tumor necrosis factor-alpha (TNF-a), matrix metalloproteinases (MMPs), and interleukins (IL-1 and IL-8). An elevated serum CRP level suggests that the inflammation arising as a result of periodontitis may correlate with cardiovascular pathology. Additionally, smoking creates an increasingly favorable environment for the growth of periodontal pathogens, thus furthering the disease process. In recent meta-analysis, published articles on the effect of saffron supplementation on three inflammatory biomarkers (CRP, TNF-α, and IL-6) were evaluated. Combining eight eligible trials, it was demonstrated that saffron supplementation did not have a significant effect on serum levels of the three inflammatory biomarkers. However, in the subgroup analysis, saffron was found to significantly reduce CRP and TNF-α serum concentrations

NCT ID: NCT06212635 Recruiting - Clinical trials for Inflammation in Decompensated Liver Cirrhosis

Hemostasis in Liver Cirrhosis and Hepatocellular Cancer

HELICS
Start date: December 2, 2022
Phase:
Study type: Observational

Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.

NCT ID: NCT06207760 Recruiting - Depression Clinical Trials

Effect of Minocycline on Inflammation in Depressed Patients

Start date: August 28, 2023
Phase: Phase 2
Study type: Interventional

The study aims to evaluate or to assess: - An improvement in the peripheral inflammatory levels in depressed patients after 8 weeks of treatment with Minocycline in addition to their current antidepressant treatment; - Any improvements in depressive symptoms after 8 weeks of treatment with Minocycline given as adjuvant to the current antidepressant treatment; - Changes in the inflammatory status in the brain (in terms of microglia activation with 11C PK PET) after 8 weeks of treatment with Minocycline in addition to the current patient's treatment; - Possible structural and functional brain changes evaluated by MRI after 8 weeks of treatment with Minocycline given as adjuvant to the current patient's treatment; - Whether changes in MRI, in microglia activation, and peripheral inflammation correlate with the improvement in depressive symptoms. In order to achieve these, a total of 60 patients, male and female, aged 25-45, who have not responded to their pharmacological treatment and who have medium-high levels of inflammation (with CRP> 2 mg/L) will be included in the study. Enrolled patients will receive, in addition to their current antidepressant treatment, Minocycline (200 mg/day as total dosage) for 8 weeks. Patients will be subjected to blood collection and clinical evaluations at baseline and after 8 weeks of treatment with Minocycline. A subgroup of patients will be subjected to MRI and 11C PK PET assessment at baseline and after 8 weeks of treatment with Minocycline.

NCT ID: NCT06203015 Recruiting - Clinical trials for Major Depressive Disorder

The Relations Among Endotoxin, Inflammatory Cytokines, Cognitive Markers and Brain MRI Changes in Subjects With Depressive Disorder

Start date: June 1, 2022
Phase:
Study type: Observational

Major depressive disorder (MDD) is a chronic mental illness, with 60% lifetime risk of recurrence after the first MDD episode. Despite available treatment options for MDD, only about half to two-thirds of patients respond to first-line antidepressant treatment, and only 30% to 45% of patients achieve remission. Scholars assume that this low remission rate and high rate of treatment resistance are due to the polyetiological nature of the disease, the heterogeneity of the clinical picture of depression, and the lack of biomarkers to stratify MDD subtypes. The aetiology of MDD, although researched extensively, remains unclear. None of the known mechanisms alone explains the pathogenesis of depression, meaning that the interplay of several factors contributes to the development of MDD. Accumulated scientific evidence has supported the importance of the immune system in the etiopathogenesis of MDD. Until now, the cause of the low-grade inflammation observed in this subgroup of MDD patients has been unclear. In the proposed study, the investigators will test a new hypothesis of the immune theory of the development of MDD: the endotoxin hypothesis of neurodegeneration. This hypothesis states that endotoxin, causes or contributes to neurodegeneration. Blood plasma levels of LPS are normally low but are elevated during infections, gut inflammation, gum disease, and neurodegenerative diseases. Dysbiosis may promote increased intestinal permeability ("leaky gut"), which leads to bacterial translocation across the intestinal barrier and into the circulation, thus forming of LPS and LPS-binding protein complex, which triggers the secretion of cytokines. Data suggest that LPS-induced peripheral inflammation can activate neuroinflammation. However, it is not known whether a low-level persistent presence of LPS in the circulatory system can cause low-grade chronic neuroinflammation leading to neurodegeneration and/or symptoms of MDD. Based on existing preclinical and clinical research data, the investigators hypothesise that an increase in blood plasma endotoxin and peripheral cytokines induce BBB dysfunction, neuroinflammation and neurodegenerative processes in specific etiologically relevant structures of the brain and cause clinical manifestation of depressive symptoms and cognitive damage. In this study the investigators are also going to investigate the effects of single nucleotide polymorphisms of four genes in relation to blood plasma endotoxin and peripheral cytokines concentrations and clinical manifestation of MDD.

NCT ID: NCT06200207 Recruiting - Heart Failure Clinical Trials

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

ATHENA
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.

NCT ID: NCT06186843 Recruiting - Hypertension Clinical Trials

Plant-based Diet for Kidney Transplant Recipients

Start date: February 29, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate cardiometabolic and inflammatory parameters in kidney transplant recipients after transitioning to a plant-based diet (PBD). The main aims of the study are as follows: - To test the feasibility of transiting renal allograft recipients who are > 3 months post-transplant to a PBD - To study the effect of a PBD on cardiometabolic parameters in kidney transplant recipients - To assess the effect of a PBD on peripheral blood Th17/Treg ratio and systemic inflammation in kidney transplant recipients Participants will be asked to: - Complete a 2-week investigator-designed PBD transition program - Follow a PBD for a minimum of 16 weeks - Consent for blood draws, urine samples, and fecal samples along with physical exams - Complete intermittent food frequency questionnaires and quality of life questionnaires - Periodically meet with investigators and other study participants Researchers will compare baseline measurements with future measurements for each participant.

NCT ID: NCT06186102 Recruiting - Obesity Clinical Trials

Polyamine Treatment in Elderly Patients With Coronary Artery Disease

PolyCAD
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

The present study is testing spermidine treatment in elderly patients with coronary artery disease. The study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group, single centre, clinical study.