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Inflammation clinical trials

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NCT ID: NCT02486367 Completed - Inflammation Clinical Trials

Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR)

Start date: June 2015
Phase: Phase 4
Study type: Interventional

The central hypothesis of this study is that TAVR leads to platelet deposition and inflammatory cell activation that can be attenuated by the potent anti-platelet and/or pleiotropic effects of ticagrelor. This single center, prospective randomized trial addresses the following specific aims: 1. To determine whether high-potency ADP receptor blockade reduces measures of platelet activation in patients after TAVR. 2. To determine whether high-potency ADP receptor blockade mitigates the pro-thrombotic inflammatory response observed after TAVR.

NCT ID: NCT02481375 Completed - Inflammation Clinical Trials

Is Iron Deficiency the Cause of Anemia Among Women in Cambodia?

Start date: July 2015
Phase: N/A
Study type: Interventional

Globally, the most common cause of anemia is thought to be iron deficiency anemia (IDA). This was assumed to be the major cause of anemia in Cambodia, because Cambodian diets, which consist mainly of rice, lack iron-rich animal food sources. However, our findings from a previous study in Cambodia (a Canadian government funded study investigating multiple interventions to improve food and nutrition security) showed that IDA is almost non-existent and challenges this assumption. In a cross-sectional survey of 450 women from rural Cambodia, only 1.0% had Hb and ferritin levels indicative of IDA (Hb <120 g/L and ferritin <15 μg/L). A national survey conducted by UNICEF in 2014 found similarly low rates of IDA (Dr. Arnaud Laillou, UNICEF Cambodia). Further, other micronutrients known to be associated with anemia were also low (<3%) including folate and vitamins B12 and B6. In addition, 54% of the Prey Veng women had a genetic Hb disorder (e.g., α-thalassemias), which are inherited diseases that can result in a defective Hb structure and/or impair Hb production, either of which can reduce Hb concentration and increase the risk of anemia. Further, genetic Hb disorders cause ferritin and soluble transferrin receptor (sTfR) concentrations to increase, which reduce the diagnostic sensitivity of these biomarkers to identify IDA. In 2011, the Cambodian Ministry of Health (MOH) recommended weekly iron and folic acid (IFA) supplementation for all women of reproductive age, consistent with WHO guidelines. However, if iron deficiency is not a major cause of anemia, then at best supplementation is a waste of valuable resources and at worst could cause harm. Further, the justification for provision of multiple micronutrients among this population has not yet been proven, despite the push from some organizations such as the WHO. There is an urgent need to conduct a trial to clarify whether iron or other micronutrient deficiencies are a major cause of anemia in Cambodia. Research Objectives: 1. To compare Hb concentration (g/L) after 12-weeks of supplementation in women to determine if iron significantly improves Hb concentration, compared to a placebo; 2. To compare Hb concentration (g/L) across the four groups (multiple micronutrients with iron, multiple micronutrients without iron, iron alone, and placebo) after 12-weeks; and 3. To determine which of the hematological indicators (ferritin, sTfR, reticulocyte count and hepcidin) have the strongest diagnostic ability to predict responsiveness to iron therapy after 12-weeks using receiver operating characteristic (ROC) analyses. Methods: A 2 x 2 factorial randomized controlled trial will be conducted over 12 weeks. A total of ~800 women (18-45 y) with mild or moderate anemia will be recruited and randomized to 1 of 4 groups: multiple micronutrients with iron, multiple micronutrients without iron, iron alone or placebo. Blood will be collected at baseline and at 1 and 12 weeks after the intervention and assessed for Hb, hematological biomarkers, inflammation and genetic Hb disorders. The investigators will use a general linear model to measure differences in Hb concentration across the four groups after the intervention. Receiver operating characteristic curves will be used to determine the diagnostic ability of the multiple hematological indicators to predict responsiveness to iron therapy.

NCT ID: NCT02479334 Completed - Healthy Clinical Trials

Acute Effects of Spices on Pathways Associated With Glucose Homeostasis and Inflammation on PBMCs of Healthy Subjects

Start date: June 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to investigate the effect of spices on gene expression of pathways associated with glucose homeostasis, oxidative stress and inflammation, in the postprandial phase in healthy human subjects.

NCT ID: NCT02476656 Completed - Preterm Birth Clinical Trials

Placental Inflammation in Prenatal Care

PINC
Start date: June 2015
Phase:
Study type: Observational

Objective of study is to explore expression of stress-related genes and inflammation in placentas and umbilical cord blood for women participating in group prenatal care compared with women receiving individual prenatal care.

NCT ID: NCT02475694 Completed - Inflammation Clinical Trials

Acute Lung Injury After Cardiac Surgery: Pathogenesis

ALI
Start date: September 2008
Phase: N/A
Study type: Observational

The purpose of the present study is to visualize the inflammatory response and coagulation disorders during cardiac surgery in order to identify possible predictors for acute lung injury postoperatively.

NCT ID: NCT02473835 Completed - Inflammation Clinical Trials

Effects of a Short Term Caloric Restriction on T Cell Activation in Fat

Start date: January 2013
Phase: N/A
Study type: Interventional

Overweight and obesity are major problems and their complications such as cardiovascular disease and type 2 diabetes mellitus pose great burdens on healthcare systems. There is accumulating evidence to support obesity being a chronic inflammatory disorder mediated in part by the expansion of adipose (fat) tissue. In addition to adipocytes (fat cells), adipose tissue contains a whole range of other cell types including some immune (white blood) cells. The relative proportions of immune cell subpopulations and interactions between the different cell types within adipose tissue may be important in the development of type 2 diabetes. Previous research by the investigators has suggested that there may be important differences in the activation status of certain immune cells located in adipose tissue with increased overweight and the production of leptin - an appetite regulating hormone. Properties of adipose tissue and inflammatory cells located within it may therefore be sensitive to changes in our nutritional status. The purpose of the present study is to investigate changes in T cell activation in adipose tissue alongside other immunometabolic properties before and after a short period of dieting compared to changes in blood. Participants will include males aged between 35-55 years old who meet the criteria for inclusion. After taking some preliminary measurements and monitoring of normal daily activities, participants will reduce their calorie intake to 50 % of their normal intake/requirements for 3 consecutive days and will attend 1 session of Laboratory testing before and 1 after this period which will take place in the Physiology Laboratories at the University of Bath. It is hoped that investigating immunometabolic responses within adipose tissue following an acute nutritional challenge will help lead to a better understanding of the development of diseases associated with being overweight and ultimately help in the development of more effective methods for prevention and treatment.

NCT ID: NCT02472171 Completed - Inflammation Clinical Trials

Suppression of Postprandial Monocyte Activation by Blueberries or Docosahexaenoic Acid in Humans

Start date: June 2015
Phase: N/A
Study type: Interventional

The overall goal of the research study is to determine whether a high-fat meal causes postprandial (after meal) inflammation, and whether eating n-3 polyunsaturated fatty acids (PUFAs) or blueberries that are rich in anti-inflammatory polyphenols suppress the inflammation in healthy people.

NCT ID: NCT02471118 Completed - Clinical trials for Osteoarthritis, Knee

Osteoarthritis of the Knee, Inflammation, and the Effect of Adalimumab (OKINADA)

OKINADA
Start date: March 2015
Phase: Phase 2
Study type: Interventional

This is a Canadian randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the clinical efficacy and safety of adalimumab versus placebo when used to treat subjects with a diagnosis of osteoarthritis of the knee, and with clinical features of inflammation, whose pain persists despite receiving maximum tolerated doses of conventional therapy.

NCT ID: NCT02471053 Completed - Inflammation Clinical Trials

Exercise to Prevent AnthrCycline-based Cardio-Toxicity Study

EXACT
Start date: February 2016
Phase: N/A
Study type: Interventional

As the numbers of cancer survivors grow, the long-term adverse effects of cancer therapy are becoming increasingly apparent. Most prominent are the toxic effects on the heart (cardiotoxicity) which may lead to cardiac dysfunction and increased risk of cardiovascular disease (CVD). The investigators hypothesize that an individualized aerobic training program for cancer patients receiving active treatment will be both feasible and safe and will result in improvements in overall levels of physical activity and quality of life. Feasibility will be assessed by evaluating the recruitment, adherence and attrition rates, along with program safety. Efficacy will be assessed by evaluating changes in health-related outcomes.

NCT ID: NCT02468752 Completed - Inflammation Clinical Trials

Reduction of Venous Emboli Load After Breathing Normobaric Oxygen Compared to Air

Start date: May 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Primary objective: - Assessment of venous gas emboli load post diving when breathing normobaric oxygen compared to air. Secondary objective: - Assessment of fluid markers of central nervous system injury in blood post diving - Assessment of fluid markers of inflammation and endothelial dysfunction in blood post diving Tertiary objective: - Assessment of DCS frequency