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Inflammation clinical trials

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NCT ID: NCT00353964 Recruiting - Ocular Inflammation Clinical Trials

Safety and Efficacy Study of rEV131 in the Treatment of Ocular Inflammation After Cataract Surgery

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of three concentrations of rEV131, a new investigational anti-inflammatory agent, compared to placebo (an inactive substance) and an FDA approved anti-inflammatory agent in patients with ocular inflammation who have undergone cataract extraction with intra-ocular lens implantation.

NCT ID: NCT00344266 Completed - Obesity Clinical Trials

Gene Expression and Inflammation in Overweight Subjects

Start date: June 19, 2006
Phase:
Study type: Observational

This study will look at gene expression (whether particular sets of genes are activated ["turned on"] or deactivated ["turned off"]) in overweight people as compared to non-overweight individuals. It will also investigate the potential role of inflammatory and protective substances that are produced naturally by the body within fat tissue. Findings from the study may lead to the development of ways to predict who will respond best to diet therapy. Healthy individuals between 25 and 45 years of age may be eligible for this study. Overweight subjects must have a BMI of 25 to 40, and non-overweight control subjects a BMI of 19 to 24.9. Candidates are screened with a medical history, physical examination, blood tests and electrocardiogram (EKG). They are instructed to record their dietary intake for a 3-day period and to collect their urine for a 24-hour interval. Participants have their food records reviewed a week after the screening visit. They are then scheduled for an overnight admission to the Clinical Center. Non-overweight subjects have one or two inpatient stays; overweight subjects have six inpatient stays plus frequent nutrition counseling sessions. During the 2-day hospital admissions, the following studies are performed: - DEXA scan to determine the percentage of body fat tissue. The subject lies on a table for about 15 to 60 minutes while the body composition is measured with very low-dose x-rays. - Single-slice CT scan to compare the amount of fat tissue under the skin with that in the abdomen. The subject lies on a table for about 5 to 10 minutes while the CT scanner measures body composition with very low-dose x-rays. - Subcutaneous fat microdialysis to investigate how weight loss affects the activity of fat tissue. A small tube (catheter) is placed into the fat tissue under the skin of the abdomen after numbing the skin with a local anesthetic. Fluid samples are collected through the tube. The procedure lasts overnight. In five non-overweight controls, a small amount of a substance called leukotriene B4 is put into their fat tissue to help adjust the instruments used in the study. - Air-displacement plethysmography to measure body composition. Subjects wear close-fitting clothing and enter a small capsule called a Bod-Pod. They breathe normally in the capsule while their body fat composition is studied. - Blood tests. Blood samples are drawn to analyze thyroid hormones, lipids, glucose, electrolytes, clotting factors, kidney function, red cells and DNA. - Euglycemic-hyperinsulinemic clamp to measure the effects of insulin in the body and to derive an index of insulin-sensitivity. Catheters are placed in a vein in an arm and in a vein in the hand on the other side of the body. Insulin and glucose are infused through the catheter in the arm, and blood samples are drawn from the catheter in the hand every 5 minutes to measure glucose levels. The test lasts about 2 hours. - Subcutaneous fat biopsy to find out how weight loss affects fat tissue characteristics, gene regulation and the ability to store glucose. A small sample of fat tissue is obtained from the skin of the abdomen after numbing the area with an anesthetic. - Nutrition counseling for overweight subjects. A nutritionist reviews the food record and designs a personalized diet for each participant. - Weight loss intervention for overweight subjects. In addition to individual nutritional counseling, group sessions are provided every 2 weeks during the first 3 months of the study and then every month.

NCT ID: NCT00339703 Completed - Asthma Clinical Trials

Levels of Serum Resistin in Asthmatics as a Potential Marker of Systemic Inflammation and Disease State.

Start date: November 2004
Phase:
Study type: Observational

The purpose of this study is to determine whether serum resistin levels in asthmatics are elevated. We will recruit subjects from the allergy/immunology clinic with a prior diagnosis of moderate to severe persistent asthma in addition to subjects being seen for evaluation of drug allergies. Based on the inclusion and exclusion criteria below, subjects will be placed into a control and asthma group. Each subject will undergo one blood draw in the main lab at WHMC, and return a lavender top tube to the allergy/immunology clinic for the EIA resistin assay. The patient will then have a brief encounter with a physician to determine an up to date history of asthma symptoms prior to participating in the exhaled NO test. The entire subject encounter will take place with one clinic visit, and requires no follow up visits as part of the study. The greatest risk to each subject will be the blood draw, as the exhaled NO is a completely non-invasive test. Plasma from each subject will be stored in a -70° freezer for no more than one month. Samples will be analyzed for resistin levels using an EIA assay run monthly. Mean values from serum CRP, serum glucose, serum resistin, and exhaled NO will be compared using a students T-test.

NCT ID: NCT00339469 Completed - Inflammation Clinical Trials

Effect of High-Legume Diet on Colorectal Cancer Risk

Start date: August 3, 2005
Phase: Early Phase 1
Study type: Interventional

This study, sponsored by the National Cancer Institute and Penn State University, will examine how a diet high in legumes (dried beans) influences risk factors for colon cancer and polyps. Many scientists believe that colon and rectal cancers develop from polyps (tumors of the lining of the large bowel). This study will test whether a high-legume diet can reduce levels of certain factors (blood insulin, blood glucose, and markers of inflammation such as C-reactive protein) that at elevated levels are known to increase the risk of colorectal polyps and colon cancer. Healthy men between 35 and 75 years of age may be eligible for this study, conducted at Penn State University in University Park, Pennsylvania. Candidates are screened with blood tests and measurements of height, weight, and blood pressure. All candidates must have had a colonoscopy within 2 years of entering the study. They may or may not have had adenomas and may or may not be insulin-resistant. Candidates must not have cancer, heart disease, kidney disease, diabetes, or other serious medical condition, and they must have no history of colorectal cancer, polyp removal, bowel surgery, polyposis syndrome, or inflammatory bowel disease. Participants undergo the following tests and procedures: - Caloric requirement testing: The subject's resting metabolic rate is measured while fasting and in the early morning at rest to determine daily calorie requirement before beginning the study diet. A special clear plastic hood is placed over the subject's head while his breathing is measured. He can communicate with the technician at all times during the 30-minute test. - Study diet: Subjects follow two required 4-week diets with a 3-week break in between, followed by an optional third 4-week diet. Subjects eat a healthy American diet for both of the required 4-week diet periods; about 1-1/2 cups of cooked legumes, such as pinto, baked, and navy beans are added to one of the two required diets. For the third (optional) diet period, subjects are given the same 1-1/2 cups of legumes, but are allowed to lose weight. Participants are given packages with all of the food they are to consume during the three diet periods. They may add up to five caffeine-containing beverages per day and up to two alcoholic drinks per week. They must eat all of the food they are given and only the food they are given. Subjects are expected to maintain a constant body weight during the two 4-week required diets, and their caloric intake may be increased or decreased as needed to maintain their screening weight. - Weight measurements: Subjects are weighed regularly at the clinic. - Blood samples: Subjects have blood samples drawn at the mid-point of each of the two required 4-week diets and at the beginning and end of each of the three 4-week diets. - Urine and stool samples: Urine and stool samples are collected at the beginning and end of the two required 4-week diets.

NCT ID: NCT00336908 Completed - Inflammation Clinical Trials

Inflammatory Responses to Lipid Emulsions in Children Before and After Open Heart Surgery

Start date: November 2005
Phase: Phase 2/Phase 3
Study type: Interventional

This study is a blinded, randomized, controlled prospective trial comparing immune response (sepsis, inflammatory response, pulmonary vasoconstriction) in 2 groups of infants less than 3-month old receiving pre and post cardiopulmonary bypass surgery. The infants will receive 1 out of the 2 following intravenous lipid preparations: Soybean Oil (n-6), or a combination of Medium Chain Triglyceride i.e. coconut oil, Long Chain Triglyceride i.e. Soybean Oil, and Fish Oil (MCT:LCT:FO). There will be 16 subjects in each group.

NCT ID: NCT00333918 Completed - Pain Clinical Trials

Safety/Efficacy of Bromfenac Ophthalmic Solution for Ocular Inflammation and Pain Associated With Cataract Surgery

Start date: June 2006
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.

NCT ID: NCT00331084 Completed - Clinical trials for Inflammation Following Cataract Surgery

Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Postoperative Inflammation in Cataract Surgery

Start date: April 2006
Phase: N/A
Study type: Interventional

efficacy of antibiotic steroid combination compared with individual administration in prevention of postoperative inflammation in patients having cataract surgery

NCT ID: NCT00330967 Completed - Inflammation Clinical Trials

Mechanisms of Insulin Resistance in Humans

Start date: April 2006
Phase: N/A
Study type: Observational

The Objectives of the study are to: (1)compare the inflammatory response and insulin resistance in skeletal muscles during a systemic infusion of lipid with that during a local infusion of lipid into the femoral artery. which would cause minimal or no systemic hyperlipidemia but local plasma free fatty acid (FFA) concentrations similar to those during the systemic lipid infusion, and (2) determine the inflammatory response and insulin resistance in skeletal muscle during an infusion of lipid into the femoral artery as described above after NF-KB inhibition by high dose salicylate treatment in humans.

NCT ID: NCT00330824 Completed - Clinical trials for Post Lasik Surgery Inflammation

Efficacy/Safety of Antibiotic Steroid Combination in Prevention of Post Operative Inflammation in LASIK Surgery

Start date: April 2006
Phase: N/A
Study type: Interventional

Efficacy/Safety of antibiotic steroid combination compared with individual administration in inflammation Post-LASIK

NCT ID: NCT00330733 Completed - Inflammation Clinical Trials

Salsalate Therapy to Reduce Insulin Resistance and Cardiovascular Risk

Start date: January 2007
Phase: Phase 2/Phase 3
Study type: Interventional

The hypothesis is that salsalate therapy may be an effective and safe method to modulate inflammation in metabolically-critical tissues and thus reduce insulin resistance and its related complications. The objectives of the study are to (1) determine whether salsalate therapy improves insulin resistance in subjects with IGT and changes in glucose area under the curve following a standard oral glucose tolerance test (OGTT); (2) determine whether salsalate therapy reduces a) plasma levels of a variety of well established inflammatory proteins and b) mononuclear cell inflammatory activity to provide evidence of reduced systemic and tissue inflammation, respectively; and (3)also determine whether salsalate therapy improves parameters of cardiovascular disease risk, including features of metabolic syndrome (fasting glucose, triglycerides, HDL, and blood pressure) as well as endothelial dysfunction.