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Inflammation clinical trials

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NCT ID: NCT00263237 Completed - Clinical trials for Common Variable Immunodeficiency

STA-5326 Meslylate to Treat Gut Inflammation Associated With Common Variable Immunodeficiency

Start date: December 2, 2005
Phase: Phase 1
Study type: Interventional

This study will determine whether an experimental medicine, STA-5326 mesylate, is safe to use in patients with common variable immunodeficiency (CVID) who have inflammation of the gut. It will also determine if patients who take this drug show improvement in their symptoms, decrease in inflammatory chemicals in the gut, changes in their immune cells, and improvement in how their gut is functioning to absorb food. Patients between 18 and 75 years of age with CVID and chronic diarrhea or involuntary weight loss of more than 5 percent of their past body weight over the past 12 months may be eligible for this study. Candidates are screened with a review of their medical records, a medical history and physical examination, blood, urine and stool tests, chest x-rays and skin test for exposure to tuberculosis, and a hydrogen breath test. For the latter, breath samples are collected before and every 20 minutes (for 2 hours) after the subject drinks a sugar solution. This test determines the digestive effects of bacteria in the upper intestine. Samples are collected by having the subject blow into a balloon. Participants undergo the following tests and procedures: Immune System and Gastrointestinal Evaluation - 48-hour stool fat collection (measures the amount of undigested fat in the stool): Subjects keep a diary of what they eat for a 48-hour period. At the beginning of the 48 hours they take two dye capsules and then take another two capsules 48 hours later. They collect a stool sample when they pass the second set of capsules in their bowel movement. An additional 24-hour stool collection is tested for loss of protein in the stool. - D-xylose absorption test (measures the ability of the gut to absorb nutrients): Subjects drink a solution of d-xylose (a sugar substitute). Blood samples are collected before and 1 hour after drinking the solution. - Upper endoscopy: A thin flexible lighted tube is advanced through the mouth to evaluate the esophagus, stomach and beginning of the small intestine. - Lower endoscopy: A thin flexible lighted tube is advanced through the rectum to evaluate the colon. Treatment Period (Study days 1 to 57) - Physical examination - study days 1, 8, 15, 29, 43 and 57 - Blood samples to test the levels of STA-5326 in the blood. On study days 1 and 57, samples are collected before the medication dose and 1, 2, 4, 6 and 8 hours after the dose; on day 29, one sample is collected before the medication dose. - Blood samples for routine safety testing - study days 1, 8, 15, 29, 43 and 57 - Medication history - study days 1, 8, 15, 29, 43 and 57 - Interview about pain, discomfort, and well being - study days 1, 8, 15, 29, 43 and 57 - Pregnancy test for women who can become pregnant - study days 15, 43, and 57 - D-xylose absorption test - study days 29 and 57 - Electrocardiogram - study days 29 and 57 - Urine test - study days 29 and 57 - Blood test for research on immune cells - study day 57 - Repeat endoscopies and studies of gut function (24- and 48-hour stool collections) Follow-up period (Day 85 and day 113) -Physical examination, blood tests, medication history, questions about pain, discomfort and well being

NCT ID: NCT00258115 Completed - Obesity Clinical Trials

The Study of Inflammation on Blood Glucose Levels in Obese People

Start date: December 2003
Phase: Phase 2
Study type: Interventional

Chronic subaccute inflammation may underlie the development of diabetes cardiovascular disease and other components of the metabolic syndrome. Rodent studies suggest diet induced obesity is associated with activation of the IKK/NF-kB pathway and this pathway can be inhibited by salicylates. This study seeks to determine the effect of salicylates in overweight persons.

NCT ID: NCT00257244 Completed - Trauma Clinical Trials

Inflammation and the Host Response to Injury (Burns)

Start date: April 2004
Phase:
Study type: Observational

The purpose of this study is to help improve our understanding of the biology involved in the body's response to serious trauma or burn injury. The host response to trauma and burns is a collection of physiological and pathophysiological processes that depend critically upon the regulation of the human innate immune system, with particular emphasis on the inflammatory component of that system. No single research center or small group of centers has the capacity to delineate the integrated response of this complex biological system, which involves multiple molecular and genetic interactions that vary in time. Our proposal promotes the identification of important dynamic relationships that regulate the integration of this complex biological system, with the expectation that this understanding will ultimately impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.

NCT ID: NCT00257231 Completed - Trauma Clinical Trials

Inflammation and the Host Response to Injury (Trauma)

Start date: November 2003
Phase:
Study type: Observational

The purpose of this study is to help improve our understanding of the biology involved in the body's response to serious trauma or burn injury. The host response to trauma and burns is a collection of physiological and pathophysiological processes that depend critically upon the regulation of the human innate immune system, with particular emphasis on the inflammatory component of that system. No single research center or small group of centers has the capacity to delineate the integrated response of this complex biological system, which involves multiple molecular and genetic interactions that vary in time. Our proposal promotes the identification of important dynamic relationships that regulate the integration of this complex biological system, with the expectation that this understanding will ultimately impact the diagnosis, prognosis, and treatment of the hospitalized, severely injured patient.

NCT ID: NCT00255242 Completed - Cystic Fibrosis Clinical Trials

Effect of Simvastatin on CF Airway Inflammation

Start date: July 2004
Phase: Phase 1
Study type: Interventional

Individuals with cystic fibrosis (CF) have persistent infection in the airways, which the body attempts to fight by recruiting immune cells (neutrophils) to the lung. The immune system and neutrophils are unable to completely kill the bacteria, and the response to the infection leads to inflammation (swelling) of the airways and lung damage. Nitric oxide (NO) has anti-bacterial and anti-inflammatory properties in the lung. NO production is decreased in CF patients, and may contribute to the persistent infection and inflammation. Increasing the production of NO in the airways of CF patients may help decrease this inflammation and infection. Rho GTPases are molecules in the cells that line the airways that decrease the protein that makes nitric oxide (NOS). Rho proteins also increase inflammation in these cells. Rho proteins are increased in CF cells, and may partially explain the low NO and high inflammation seen in CF. Blocking the Rho protein in CF cells increases NOS, which can then produce more NO. The Rho protein can be inhibited with a drug, simvastatin (Zocor®). Simvastatin is used by millions of people to lower their cholesterol, is very safe, has few side-effects and is approved for use in children greater than 10 years of age. We propose that treating CF patients with simvastatin will increase NO produced (exhaled NO), and may decrease airway inflammation. If simvastatin has these expected effects in CF, it would be another drug that has potential to become a new therapy to fight the debilitating lung damage of the disease.

NCT ID: NCT00252967 Terminated - Atrial Fibrillation Clinical Trials

Atorvastatin Therapy for the Prevention of Atrial Fibrillation (SToP-AF)

Start date: October 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test whether the drug, atorvastatin, will be able to reduce the rate of return of the abnormal beats after using cardioversion. Atorvastatin is a drug approved by the Food and Drug Administration (FDA) for the treatment of high cholesterol but is not approved for preventing abnormal heartbeats. In addition to lowering cholesterol, the drug reduces inflammation. Inflammation seems to help cause atrial fibrillation, a certain type of abnormal heartbeat. In animals, atorvastatin reduces the risk of this type of abnormal beats, and preliminary data in humans supports an effect of atorvastatin and other similar drugs that have the same action on reducing the risk of this type of abnormal beats. We, the researchers at Emory University, would like to learn if this drug could prevent the return of these abnormal heartbeats.

NCT ID: NCT00251654 Completed - Inflammation Clinical Trials

Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia

Start date: January 2002
Phase: Phase 4
Study type: Observational

The investigators prospectively document infectious, neurological, and other complications or adverse events occurring during peripheral regional anesthesia via a catheter using computer-based data recording.

NCT ID: NCT00247507 Active, not recruiting - Anemia Clinical Trials

The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients

Start date: September 2005
Phase: Phase 4
Study type: Interventional

The aim of this study is to explore and identify the effects of acetylcysteine, a common mucolytic with anti-oxidant property, on alleviating the damage caused by increased oxidative stress in hemodialysis patients.

NCT ID: NCT00243802 Terminated - Atrial Fibrillation Clinical Trials

Markers of Oxidative Stress Present in Left Atrial Appendage Tissue in Patients With Atrial Fibrillation

Start date: May 2005
Phase: Phase 2
Study type: Observational

The purpose of the study is to look at the differences between people who have irregular heart beats coming from the upper chamber of the heart (atrial fibrillation) compared to those who do not have these irregular beats.

NCT ID: NCT00241774 Completed - Depression Clinical Trials

Coronary Heart Disease Incidence: Depression & Inflammation Risk

Start date: August 2005
Phase: N/A
Study type: Observational

To examine the associations among depression, inflammation, and coronary heart disease using an existing data base and associated plasma samples.