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NCT ID: NCT02015299 Completed - Clinical trials for Type 2 Diabetes Mellitus

Off taRget Effects of Linagliptin monothErapy on Arterial Stiffness in Early Diabetes

RELEASE
Start date: March 2014
Phase: Phase 3
Study type: Interventional

Diabetes is associated with an increased risk for developing premature macrovascular complications. The process of irreversible subclinical damage to the vasculature already starts during its preceding stages. Dipeptidyl peptidase (DPP)-4 inhibitors have been shown to attenuate vascular damage in preclinical studies. Off-target effects on adipose tissue inflammation, liver steatosis and atherosclerotic plaques have been extensively documented in animal studies. Based on these considerations the investigators hypothesize that early therapy with the DPP4 inhibitor linagliptin in subjects with treatment naive type 2 diabetes will lead to beneficial effects on arterial stiffness as measured by pulse wave velocity.

NCT ID: NCT02014324 Completed - Clinical trials for Non Small Cell Lung Cancer (NSCLC)

Single Scope Staging of Lung Cancer With Endosonography

SCORE
Start date: May 2013
Phase: N/A
Study type: Observational [Patient Registry]

Rationale: Lung cancer is the most commonly diagnosed cancer worldwide and is the most frequent cause of cancer death. Accurate staging is important because it directs treatment and prognosis. Mediastinal staging can be done by both EBUS-TBNA and EUS-FNA. These two techniques have a complementary diagnostic range and the combined procedure is suited for assessment of almost the entire mediastinum. In practice, when mediastinal tissue staging is indicated, endoscopists often perform either an EBUS or an EUS investigation (instead of the combined procedure). Second, frequently only one or two, by imaging suspected lymph node stations, are sampled (ie. targeted approach). Objectives: main and secondary: 1. Complete endosonographic (combined endobronchial and esophageal) staging using a single EBUS scope improves locoregional staging (N2, N3, T4) versus EBUS staging alone. 2. Systematic mediastinal staging results in improved locoregional staging compared to PET-CT directed assessment of the mediastinum (ie targeted approach). Study population: Patients with potentially operable and resectable NSCLC are eligible if there is an indication for mediastinal nodal sampling. Patients have an indication for EBUS-TBNA. Intervention: Patients will undergo an EBUS investigation followed by EUS-B in the same session. During this single scope procedure, lymph nodes that are suspected on prior CT-PET imaging and on subsequent ultrasound are sampled. Main study endpoint: The main study parameter is the sensitivity for locoregional disease (N2, N3, T4 disease) of complete endosonographic staging (by EBUS-TBNA and EUS-B-FNA) in comparison with EBUS staging alone.

NCT ID: NCT02013466 Completed - Sarcopenia Clinical Trials

Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement

ArenA
Start date: October 2008
Phase: Phase 1
Study type: Interventional

In this study healthy older adults are requested to consume 4 different high-protein nutritional supplements. Each subject will visit the site 4 times and at every visit they will consume 1 of the 4 products after which a series of blood samples will be taken. The blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours after consumption.

NCT ID: NCT02013206 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy

Start date: September 2006
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.

NCT ID: NCT02012673 Completed - COPD Clinical Trials

A Safety and Feasibility Study of Re-treating Patients With Severe Emphysema With the RePneu LVRC System.

RECOIL
Start date: January 2014
Phase: N/A
Study type: Interventional

Rationale: The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline. Objective: To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.

NCT ID: NCT02011672 Completed - Clinical trials for Low-grade Inflammation

Effect of Milk Ingredients on Glucose Regulation and Inflammation

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

Background: Recent advances in science have established a fundamental role for low grade chronic inflammation in mediating all stages of most of the non-communicable diseases associated with ageing. Pro-inflammatory effects of hyperglycemia have been described. Dairy and its components are known to exert beneficial effects on postprandial hyperglycemia. This study investigates if dairy, normal and enriched, can reduce chronic inflammation via improvement in glucose regulation. Objective: To compare the effect of a nutrient-enriched dairy drink on parameters of glucose regulation and postprandial inflammation with the effect of a standard milk drink, within a population of overweight, apparently healthy subjects. Study design: The study is designed as a double-blind randomized placebo-controlled parallel trial during 7 weeks, during which the test and reference products will be consumed at home. Main study parameters/endpoints: The difference in absolute change in fasting blood plasma concentration of glucose, insulin and IL-6, from baseline to endpoint, and the difference in postprandial response of plasma concentration of glucose, insulin and IL-6 at the end of the treatment period, between subjects consuming the test and reference product.

NCT ID: NCT02010762 Completed - Crohn's Disease Clinical Trials

The Effect of Vitamin D3 to Maintain Surgical Remission in Postoperative Crohn's Disease

DETECT
Start date: February 2013
Phase: Phase 4
Study type: Interventional

The majority of patients with Crohn's disease (CD) need to undergo surgical bowel resection. Postoperative recurrence of the disease is virtually inevitable and continues to be one of the most challenging therapeutic problems in inflammatory bowel diseases. Medical treatments to prevent recurrence have had limited effect. Anti-tumor necrosis factor (TNF) agents appear promising but are hampered by immunogenicity, side effects and high cost. Vitamin D has recently received a lot of scientific attention and was found to have strong anti-inflammatory and antifibrotic effects in gut and liver inflammation. Many CD patients appear to have deficiency in Vitamin D. A controlled trial to prevent relapse of CD in medical (not surgical) remission suggested a preventive effect for Vitamin D but marginally missed its endpoint because of lack of power. The ultimate proof of the anti-inflammatory effect of Vitamin D in CD can best be studied in the prevention of postoperative recurrence.

NCT ID: NCT02010255 Completed - Clinical trials for Chronic HCV Infection

Ledipasvir/Sofosbuvir Fixed-Dose Combination Plus Ribavirin in Participants With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant

Start date: January 2014
Phase: Phase 2
Study type: Interventional

This study will evaluate ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) in participants with advanced liver disease or posttransplant and chronic genotype 1 or 4 hepatitis C virus (HCV) infection. - Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant; - Cohort B: post-liver transplant, with or without cirrhosis; - Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups) - Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.

NCT ID: NCT02009865 Completed - Clinical trials for Hypertriglyceridemia

Epanova® for Lowering Very High Triglycerides II (EVOLVE II)

EVOLVEII
Start date: December 16, 2013
Phase: Phase 3
Study type: Interventional

This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects with severe hypertriglyceridemia. The study consists of an approximately 8-week screening period that includes a diet and lifestyle stabilization and washout period and a 12-week treatment period.

NCT ID: NCT02009670 Completed - Obesity Clinical Trials

Inulin,SCFA Production and Metabolic Response

Start date: February 2014
Phase: N/A
Study type: Interventional

In this placebo controlled, double-blind, randomized crossover study the investigators will investigate in overweight/obese healthy male volunteers whether inulin administration will increase intestinal SCFA production, thereby investigating whether this will lead to acute metabolic effects.