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NCT ID: NCT01854918 Completed - Clinical trials for Hyperlipidemia and Mixed Dyslipidemia

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

OSLER-2
Start date: April 23, 2013
Phase: Phase 3
Study type: Interventional

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

NCT ID: NCT01854710 Completed - Healthy Volunteers Clinical Trials

ADASUVE 2-dose Thorough QT/QTc Study

Start date: May 2013
Phase: Phase 4
Study type: Interventional

Assess the potential effects on the QT interval of 2 consecutive doses of ADASUVE administered 2 hours apart, in relation to placebo and an active control in healthy volunteers.

NCT ID: NCT01854606 Completed - Clinical trials for CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma

Safety and Efficacy of AEB071 and EVEROLIMUS in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma

COEB071X2103
Start date: December 5, 2013
Phase: Phase 1
Study type: Interventional

Study of the safety and efficacy of AEB071 and EVEROLIMUS in patients with CD79-mutant or ABC subtype Diffuse Large B-Cell Lymphoma. The trial did not progress into Phase II due to the suboptimal tolerability of the combination treatment of sotrastaurin and everolimus in the Phase Ib part of the study. There were no serious safety concerns associated with this combination.

NCT ID: NCT01854541 Completed - Cancer Clinical Trials

Visual Management for the Radiotherapy Process

VMRTP
Start date: March 2013
Phase: N/A
Study type: Observational [Patient Registry]

The Visual Management for Radiotherapy Practice (VMRTP) aims to analyze, predict, visualize and shorten the waiting times for radiotherapy patients. The hypothesis is that this can be done by the introduction of models that can predict a patient being at risk for waiting too long as well as visual management tools that visualize the radiotherapy process.

NCT ID: NCT01853579 Completed - Depression Clinical Trials

The TRUST Study - Depression Substudy

TRUST
Start date: March 2013
Phase: Phase 4
Study type: Interventional

Mild thyroid failure is a common condition among older adults and has been associated with numerous adverse effects on health, such as cardiovascular disease, cognition disturbances and muscular problems. Mild thyroid failure has also been associated with an increased risk of developing depression. To date, only few studies have investigated the effect of thyroid hormone replacement on depression in patients with mild thyroid failure. This study therefore aims to assess whether thyroid hormone replacement in older adults with mild thyroid failure is associated with a decrease in the presence of depressive symptoms. This study forms a substudy of a large international study on thyroid hormone replacement in older adults with mild thyroid failure (the TRUST study).

NCT ID: NCT01852253 Completed - Clinical trials for Periodontal Diseases

Implant Surface Decontamination With 2 % Chlorhexidine in Peri-implantitis Treatment

Start date: March 2010
Phase: N/A
Study type: Interventional

Peri-implantitis is a infectious disease that resides in the mucosa surrounding dental implants and also affects the supporting bone. Because the number of implants placed in everyday clinical practice is continuously increasing, is it reasonable to anticipate an increasing prevalence of peri-implantitis. This underlines the necessity for a predictable therapy. However, from the literature there is very little reliable evidence suggesting which could be the most effective interventions for treating periimplantitis. The primary objective of this controlled clinical study is to evaluate the clinical effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The secondary objective is to assess the microbiological effect of decontamination of the implant surface during the surgical treatment of peri-implantitis using a 2% chlorhexidine solution or a 0.12% chlorhexidine solution. The primary study parameter is the change from baseline in modified bleeding index. Secondary study parameters are: change in microbial composition of the biofilm covering the dental implant surface; microbiological composition of the peri-implant sulcus; change in probing pocket depth;change in suppuration on probing; change in radiographic marginal bone level on standardized intraoral radiographs; change in modified plaque index; implant failure, defined as implant mobility of previously clinically osseointegrated implants and removal of non-mobile implants because of progressive marginal bone loss or infection; complications and adverse events. It is hypothesized that decontamination of the implant surface with 2% chlorhexidine leads to a greater decrease in modified bleeding index than decontamination with a 0.12% chlorhexidine solution.

NCT ID: NCT01851824 Completed - Clinical trials for Malignant Melanoma, Neoplasms

A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

Start date: August 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26, eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (GO28399 [NCT01739764]).

NCT ID: NCT01851538 Completed - Heart Failure Clinical Trials

The Role of Biomarkers and Echocardiography in Prediction of Prognosis of Chronic Heart Failure Patients

Bio-SHiFT
Start date: August 2011
Phase:
Study type: Observational

The Bio-SHiFT study aims to investigate whether disease progression in individual patients with chronic heart failure (CHF) can be accurately assessed by serial measurements of disease-related (novel) biomarkers. Secondary objectives of the study include comparison of 2D- with real-time 3D-echocardiography in CHF patients and comparison of Speckle tracking with tissue Doppler imaging (TDI) in CHF patients, and relating these echocardiographic measurements to clinical outcome. Bio-SHiFT is a prospective, observational, multi-center, cohort study in men and women, aged 18 years or older, visiting the outpatient clinic. Blood samples are taken at the day of inclusion and at follow-up visits, which are performed every 3 months until the end of the scheduled follow-up. Clinical data are collected at baseline and at each 3-month follow-up visit. Echocardiography including TDI, Speckle tracking and 3D-echocardiography is performed in a subset of patients, at baseline and during follow-up at 6-month intervals. The primary endpoint is the composite of cardiovascular death, cardiac transplantation, left ventricular assist device implantation, and re-hospitalization for the management of acute or worsened heart failure.

NCT ID: NCT01851265 Completed - Solid Tumours Clinical Trials

D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

Start date: July 4, 2013
Phase: Phase 1
Study type: Interventional

This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). Treatment can continue for as long as the patient is benefitting. Throughout the study patients will be monitored for any side effects.

NCT ID: NCT01850901 Completed - Hypertension Clinical Trials

Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension

SYMPATHY
Start date: May 2013
Phase: Phase 3
Study type: Interventional

The aim of this study is to assess whether renal denervation (RD) added to usual care compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least 135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) obstructing use of 3 antihypertensives Further aims are to assess the effect of renal denervation on the use of BP lowering agents, to explore the effect of renal denervation in strata of estimated glomerular filtration rate (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR>60 mL/min per 1.73m2) and according to baseline office BP. Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.