Cognitive Function in Patients Treated for Metastatic Melanoma With Immune Checkpoint Inhibitors...
MelanomaCognitive Impairment8 moreImmune checkpoint inhibitors (ICIs) are a group of novel immunotherapies that boost the body's own defense against the cancer by improving the immune system's ability to recognize and destroy cancer cells. While it is relatively well-documented that conventional cancer treatments (e.g., chemotherapy) are associated with cognitive impairment, virtually nothing is yet known about effects on cognition during and after ICI treatment. Due to significantly improved survival rates after ICI treatments, it becomes important to map possible adverse effects associated with these treatments. The investigators therefore investigate possible changes in cognitive function in a group of cancer patients from prior to ICI treatment to nine months later. A gender- and age- matched healthy control group will serve as a comparison. The study has the potential to broaden our understanding of associations between cognition, the brain, and the immune system and to provide clinically relevant knowledge about possible cognitive impairments associated with immunotherapy.
SGLT2 Inhibitor Effects on Inflammation and Heart Disease in Obesity Pilot
ObesityPre-diabetesObesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This project will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.
Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19)...
ARDSCOVID-19To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Comprehensive Assessment of Interconnection Between Brain Emotional Activity and Coronary Plaque...
AtherosclerosisCoronary7 moreEmotional stress is associated with future cardiovascular events. However, the biological interconnection between brain emotional neural activity and acute plaque instability is not fully understood. Optical coherence tomography-Fluorescence Lifetime (OCT-FLIM) dual modal intravascular imaging is a novel technique that enables comprehensive assessment of structural and biochemical characteristics of coronary atheroma and estimates the level of plaque instability. 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG-PET/CT) enables simultaneous estimation of multi-system activities including emotional stress, arterial inflammation, and hematopoiesis. The present study aims to prospectively investigate mechanistic linkage between coronary plaque instability, stress-associated neurobiological activity, and macrophage hematopoiesis using OCT-FLIM and 18F-FDG PET/CT imaging assessment.
Adipose Tissue and Circulating Markers of Inflammation in GH Deficiency and Changes With GH Therapy...
Growth Hormone DeficiencyIn order to examine the effect of GH on adipose tissue inflammation, this study will examine adipose tissue and serum inflammation in patients with GH deficiency before and after GH therapy. The investigators will also obtain serum samples before and after treatment for adipokines, inflammatory markers and examine macrophages in circulation with regard to their inflammatory state. The investigators will also obtain adipose tissue biopsies from healthy subjects matched to the growth hormone deficiency (GHD) subjects. Adipose tissue specimens will be analyzed for adipose tissue morphology, adipocyte size, adipokine gene expression, and adipose tissue macrophage number.
Bioengineered Penile Tissue Constructs for Irreversibly Damaged Penile Corpora
Urologic DiseasesMale Urogenital Diseases4 moreThe primary objective of this clinical trial is to evaluate the safety of autologous engineered corpora cavernosa + albuginea constructs for treatment of complex penile deformities. Autologous endothelial and smooth muscle cells obtained from enrolled subjects' corpora cavernosa biopsy sample, will be culture expanded in vitro and used to seed decellularized corpora cavernosa + albuginea obtained from cadaveric-donors to create autologous bioengineered corpora cavernosa/albuginea constructs for repair of damaged penile tissues.
Inflammation and Depression in People With HIV
HIVDepression1 moreThe purpose of this 10-week, double-blind, placebo-controlled study is to determine whether inflammation impacts reward and motor neural circuitry to contribute to depressive symptoms like anhedonia and psychomotor slowing in people with Human Immunodeficiency Virus (HIV) and depression. Sixty male and female patients with HIV who have depression, anhedonia and high inflammation and are stable on effective treatment for their HIV will be randomized to receive either the anti-inflammatory drug baricitinib or a placebo for 10 weeks. Participants will complete lab tests, medical and psychiatric assessments, neurocognitive testing, functional MRI (fMRI) scans, and optional spinal taps as part of the study. The total length of participation is about 5 months.
Canagliflozin Targeting Vascular Inflammation
Diabetes Type 2Coronary Artery DiseaseCANTOR SING is a pilot single center double blinded randomized study. The investigators will compare the effect of canagliflozin (300 mg daily - intervention arm) vs. placebo (control group) on the FDG aortic uptake in patients with stable CAD (over 60 days post-myocardial infarction) after a 6-month period of treatment. The investigators plan to enroll 8 patients in each arm (total sample size: 16 patients). Primary endpoint is the change in FDG aortic uptake between baseline and 6 months in each arm.
KurCoSmart Effects on People With Type 2 DM
Diabetes MellitusType 23 moreThe investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation
CCTA Coronary Hemodynamics, Systemic Inflammation and Vulnerable Plaques (COHESIVE)
Coronary Artery DiseaseSystemic Inflammatory Response2 moreAlthough there are numerous studies that have demonstrated the impact of systemic inflammation on coronary plaque vulnerability, there are few literature data regarding the influence of coronary plaque localization within the coronary tree (right and left coronary artery, proximal, mid-coronary and distal), on plaque composition, morphology and degree of vulnerability, in relation with systemic inflammation and coronary hemodynamics. The aim of this study is to identify: (1) the impact of plaque topography in different sites within the coronary tree (right versus left, proximal distal) on their vulnerability degree evaluated with CCTA; (2) the relationship between degree of plaque vulnerability, systemic inflammatory biomarkers and specific hemodynamic characteristics quantified by coronary shear stress computations. The study will include 100 patients with stable coronary artery disease for which data collection will be perform on: (1) Clinical, echocardiographic and ECG data; (2) cardiovascular risk assessment; (3) 128 slice CCTA evaluation of coronary tree anatomy, plaque morphology, composition and vulnerability degree; (4) systemic inflammation based on serum levels of hsCRP, IL-6, MMP-9, periostin, adhesion molecules (5) shear stress via coronary flow computational simulations.