Mechanisms of Sleep Latency and Health: The Effect of a Melatonin Receptor Agonist in Inflammation...
InsomniaThe purpose of this study is to help scientist better understand the effect of a 12-week single daily evening dose of ramelteon (Rozerem ©), a drug that has been approved by the U. S. Food and Drug Administration (FDA) for the treatment of insomnia (trouble falling asleep or staying asleep). The study will measure levels of inflammation, fasting insulin and fasting glucose (sugar) in subjects who are taking either ramelteon (8 mg) or placebo.
The Effects Grapes on Health Indices
ObesityInflammation2 moreThe investigators hope to learn about the effects of whole grapes, in the form of freeze-dried grape powder, on markers of health. Phytochemical rich food consumption is associated with protection against chronic diseases such as cardiovascular disease (CVD) demonstrating the ability to modify endothelial function and lipemia, but exact causal mechanisms are still not well understood. The investigators will examine metabolic and mechanistic effects of consumption of whole grape powder in chronic as well as acute settings in response to meal challenges by testing blood samples to determine if markers of health have improved. The central hypothesis of this project is that consumption of grapes in the form of a polyphenol-rich freeze-dried whole grape powder (WGP) will attenuate chronic and meal induced oxidative stress and inflammatory responses in obese individuals.
First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
InflammationRheumatoid Arthritis1 moreThis trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug), pharmacodynamic biomarkers (biomarkers related to anti-IL-21 expected mode of action) and signs of clinical efficacy of increasing single doses, at 9 i.v. (into the vein) dose levels in Healthy Subjects , at 3 i.v. dose levels in subjects with rheumatoid arthritis (RA) and at 3 s.c. dose levels in Healthy Subjects.
Non-Inferiority of Gatifloxacin/Prednisolone Association vs Isolated Administration in Prevention...
Ocular Infection and InflammationThe purpose of the study is to evaluate the safety and tolerance of the 0.3% gatifloxacin and 1.0% prednisolone acetate association in eye drops in the prevention of infection and inflammation after refractive surgery (Lasik) and also demonstrate the non-inferiority of the efficacy of this association compared to the administration of 0.3% gatifloxacin and 1.0% prednisolone acetate as isolated eye drops formulations. The study treatment is randomized, double-masked, with 2 parallel arms. Each patient's participation lasts 29 days, with 15 days of study treatment administration after the ocular surgery is performed. Candidates for the study are patients with indication for ocular refractive surgery (Lasik) for correction of visual acuity.
Rice Bran Supplementation in Treated HIV Infection
Inflammation in HIV InfectionDouble-blind placebo-controlled randomized trial of Arabinoxylan Rice Bran Supplementation for 12 weeks with BRM4 in HIV-infected participants with inadequate immune reconstitution.
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601A-002b)...
InflammationThe purpose of this phase III study is to determine the efficacy of difluprednate in the treatment of inflammation following ocular surgery.
Bronchiectasis and Long Term Azithromycin Treatment
BronchiectasisInflammation1. SUMMARY Rationale: Patients with bronchiectasis often experience lower respiratory tract infections with progression of symptoms and decline in quality of life. Macrolides, as has been shown in panbronchiolitis and cystic fibrosis, may break or weaken the link between infection and inflammation resulting in an improvement of symptoms. Also the number of exacerbations may lowered. Objective: A reduction in number of infective exacerbations and improvement in lung function by AZT treatment are the primary objectives. Secondary objectives that will be evaluated are: symptoms score, quality of life, inflammatory parameters, bacterial colonisation, and adverse events. Study design: Randomised double blind multicenter study in the Netherlands. Patients will be stratified for colonisation with P.aeruginosa. Study population: Patients with bronchiectasis demonstrated by high-resolution computed tomography (HR-CT) scan or bronchography. Intervention: Patients receive Azithromycin 250mg(p.o.) once daily or placebo. Main study parameters/endpoints: Reduction in number exacerbations, defined as increase symptoms such as dyspnoea, coughing, and sputum production for which a course of prednisolone and/or antibiotic is needed. Change in lung function parameters (forced expiratory volume in 1 second [FEV1], forced vital capacity [FVC]) measured by spirometry is the other primary endpoint. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risk of participating in this study is low. Laboratory, radiographic examinations, and pulmonary function tests are commonly used as diagnostic procedures during outpatients visits and during exacerbations. Adverse effects in maintenance treatment with AZT are usually mild and mainly gastrointestinal. Sometimes rash and abnormal liver function tests are observed. A better quality of life will probably be the beneficial effect of long term treatment with AZT. This will be achieved by a reduction in respiratory and non-respiratory symptoms and number of exacerbations.
Antimicrobial Pulpotomy of Primary Molars
InflammationNecrosisThere is a lack of evidence of the long-term successful outcomes of antimicrobial endodontic treatment for primary teeth. This study intended to evaluate (by survival analysis) the effectiveness of an antimicrobial pulpotomy (chloramphenicol, tetracycline, zinc oxide/eugenol) in primary molars compared to calcium hydroxide pulpectomy, testing the hypothesis that antimicrobial pulpotomy could be an alternative pulp therapy for primary teeth with pulp inflammation or necrosis.
Study to Assess Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adults With...
AsthmaThis is a dose-response study to determine how various measurements of airway inflammation respond to high and low dose FlutiForm®, and compared to placebo.
A Randomized, Placebo-Controlled, Double-Blind Pilot Study of Pioglitazone Hydrochloride in Severe,...
SevereRefractory Asthma2 moreBackground: - Individuals who have severe asthma that is not easily controlled by current treatments are in need of new treatments to prevent potentially life-threatening asthma attacks. Experiments in mice have found that a medication called pioglitazone hydrochloride (Actos ), which is used to treat patients with diabetes, may be effective for treating severe asthma. Researchers are interested in determining whether Actos is effective in improving the quality of life in subjects with severe asthma who continue to have symptoms despite maximum standard medical therapy. Objectives: - To assess the effectiveness of pioglitazone hydrochloride as a treatment for patients with severe asthma that is not controlled by standard treatments. Eligibility: - Individuals between 18 and 75 years of age who have been diagnosed with and treated for severe asthma for at least 1 year. Design: Potential participants will have a screening visit to determine eligibility for the study. The visit will involve breathing tests, chest x rays, heart and lung monitoring, and blood tests. Eligible participants will have a full medical history and will answer a series of questionnaires about their quality of life with asthma. Phase 1: Patients will record lung function and asthma symptoms morning and evening for 4 weeks. At the end of this period, patients will be evaluated with breathing, allergy, and blood tests, as well as questionnaires. Patients will also provide a sputum sample. Phase 2: Patients will receive regular doses of either pioglitazone hydrochloride or a placebo for 16 weeks. Patients will return to the National Institutes of Health every 4 weeks for tests. Phase 3: Wash-out period without study drugs for 4 weeks, similar to Phase 1. Phase 4: Patients will receive regular doses of either pioglitazone hydrochloride or a placebo for 16 weeks. Patients who received placebo will be given the study drug, and vice versa. Patients will return to the National Institutes of Health every 4 weeks for tests. Phase 5: Medications will be stopped, and patients will return to the National Institutes of Health 4 weeks later for final tests.