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NCT ID: NCT01677910 Completed - Carcinoid Syndrome Clinical Trials

TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

Start date: January 8, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to confirm that at least 1 or more doses of telotristat etiprate compared to placebo is effective in reducing the number of daily bowel movements (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the trial in patients not adequately controlled by current SSA therapy.

NCT ID: NCT01676974 Completed - Clinical trials for Enterobacteriaceae, Infection

Carriage Of Multiresistant Bacteria After Travel

COMBAT
Start date: November 2012
Phase: N/A
Study type: Observational

Objectives: Prospectively study the influence of foreign travel and associated risk factors on the acquisition of AMR in the endogenous microbiota of healthy individuals and the subsequent persistence of AMR carriage and transmission to household members of these carriers. Examine whether carriers of resistant Enterobacteriaceae have a higher risk of bacterial infections in the year after travel (compared to non-carriers). Explore the full width of AMR genes and transferable genetic elements acquired during international travel.

NCT ID: NCT01676727 Completed - Aortic Stenosis Clinical Trials

ADVANCE Direct Aortic Study

Start date: September 2012
Phase:
Study type: Observational

This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.

NCT ID: NCT01676662 Completed - Clinical trials for Stress Urinary Incontinence

Solace European Confirmatory Trial

SOLECT
Start date: September 2012
Phase: N/A
Study type: Interventional

The Solace European Confirmatory (SOLECT) Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.

NCT ID: NCT01676376 Recruiting - Clinical trials for Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

The eMESH 1 Feasibility Study

eMESH 1
Start date: August 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.

NCT ID: NCT01676220 Completed - Clinical trials for Type 2 Diabetes Mellitus

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Non-insulin Antidiabetic Therapy

EDITION III
Start date: August 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at Month 6, Week 26) in participants with type 2 diabetes mellitus Secondary Objectives: To compare a new formulation of insulin glargine and Lantus in terms of: - occurrence of nocturnal hypoglycemia

NCT ID: NCT01676012 Completed - Cancer Clinical Trials

Hd-bronchoscopy, Comparison to Standard White Light and Autofluorescence Bronchoscopy

Start date: September 2012
Phase: N/A
Study type: Observational

Through technological improvement a new technique has become available in the form of high-definition (HD-) bronchoscopy. Current normal video white light bronchoscopy is the standard, and video-autofluorescence bronchoscopy (AFB) is offered by specialized centers only. The impact of this development with high-definition videobronchoscopy using a 1.1 megapixel chip on the diagnostic performance of bronchoscopy is however unknown. The aim of the present study therefore is to explore the diagnostic performance (sensitivity and specificity) of HD-videobronchoscopy, HD + surface enhancement (iScan filtering technique) and HD + tone enhancement filtering in comparison to standard WLB and dual mode SAFE3000 autofluorescence videobronchoscopy in a high risk population.

NCT ID: NCT01675882 Completed - Peanut Allergy Clinical Trials

Efficacy and Safety of Several Doses of Viaskin Peanut in Adults and Children With Peanut Allergy

VIPES
Start date: August 2012
Phase: Phase 2
Study type: Interventional

The objectives of this dose-finding study for the treatment of peanut allergy are: - To determine the efficacy of 3 doses of Viaskin Peanut (50 mcg ,100 mcg and 250 mcg peanut protein per patch) to significantly desensitize peanut-allergic subjects to peanut after 12 months of treatment. - To evaluate the safety of a long-term treatment with Viaskin Peanut.

NCT ID: NCT01675791 Completed - Clinical trials for Birch Pollen Allergy

A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet

Start date: August 2012
Phase: Phase 2
Study type: Interventional

The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.

NCT ID: NCT01675401 Completed - Obesity Clinical Trials

Body Weight and Vascular Function

Start date: September 2012
Phase: N/A
Study type: Interventional

An increased body mass impairs vascular function (VF), an important characteristic of subjects suffering from type 2 diabetes and a risk marker for cardiovascular diseases. However, a wide variety of in vivo VF markers exists each measuring different aspects of VF. Each of these markers addresses a different aspect of the vasculature. Studies comparing under standardized conditions the differences and relationships of the many different VF measurements in lean and abdominally overweight / obese subjects are missing. Also, there is a great need to know which of these markers are sensitive to dietary challenges. Therefore, it is imperative to conduct an extensive study on dietary effects and interrelationships of a broad spectrum of VF measurements and plasma biomarkers in lean and overweight / obese subjects. Focus will be on FMD, a well accepted biomarker for cardiovascular disease. The investigators propose to examine, in a two-way parallel-randomized human intervention study, the effects of weight-loss in abdominally overweight / obese men on VF markers and plasma biomarkers related to low-grade inflammation and vascular activity during the fasting and both the postprandial and hyperinsulinemic state. Furthermore, differences - and relations between - VF measurements and plasma biomarkers will be compared cross-sectionally between lean and abdominally overweight / obese male subjects.