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NCT ID: NCT01948960 Completed - Breast Neoplasms Clinical Trials

Influence of Exceptional Patient Characteristics on Everolimus Exposure

INPRES
Start date: August 2013
Phase: Phase 4
Study type: Interventional

A study to determine whether everolimus pharmacokinetics in elderly and obese patients is different compared to control patients. Furthermore the investigators will investigate the relation between metabolic response assessed with [18F] Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and everolimus exposure and clinical benefit. The investigators will explore whether dose escalation in patients who are hypothetically underexposed will result in an increase in metabolic response.

NCT ID: NCT01947985 Completed - Atrial Fibrillation Clinical Trials

Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice (Netherlands)

Start date: February 1, 2012
Phase:
Study type: Observational

This prospective cohort study will provide information about: characteristics of Rivaroxaban use in patients who are prescribed Rivaroxaban for the first time compared to patients who are prescribed Acenocoumarol for the first time, the occurrence of intracranial haemorrhage, gastrointestinal and urogenital bleeding, and the occurrence of non-infective liver disease.

NCT ID: NCT01947556 Completed - Diabetes Mellitus Clinical Trials

Insulin by Jet-injection for Hyperglycemia in Diabetes

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

The purpose of this study is to compare the pharmacokinetic and pharmacodynamic profile of the rapid-acting insulin analogue aspart (Novorapid®) injected subcutaneously by jet-injection to that of the same insulin injected with a conventional pen in the management of hyperglycemia in subjects with diabetes

NCT ID: NCT01946932 Completed - Clinical trials for Out-of-hospital Cardiac Arrest

Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

Start date: June 2011
Phase: N/A
Study type: Interventional

This is a steering group approved substudy to the Target Temperature Management trial (TTM, ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly controlled temperature regimes for survivors of out-of-hospital cardiac arrest. The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control patients with myocardial infarction. Our secondary aims are: - To investigate the impact of cognitive impairment on our patients' ability to participate in society and their health related quality of life. - To investigate the relationship between our patients cognitive impairments and their relatives/informants health related quality of life and feelings of burden. - To test the hypothesis that the simple cognitive screening battery used in the TTM main trial is sensitive enough to detect all patients with significant cognitive disability.

NCT ID: NCT01946776 Completed - Epilepsy Clinical Trials

Cardiac Arrhythmias in Epilepsy: the CARELINK-study

CARELINK
Start date: June 2013
Phase: N/A
Study type: Interventional

Patients with difficult-to-treat epilepsy ("refractory epilepsy") are at high risk of sudden death: sudden unexpected death in epilepsy (SUDEP). Cardiac arrhythmias are one of the possible causes of SUDEP. When monitoring in the hospital setting, the frequency of cardiac arrhythmias in people with epilepsy is low: 0,4%. However, when a subcutaneous implantable device (Reveal XT) is used to monitor heart rhythm continuously for an extended period of time, the frequency of clinically relevant arrhythmias appeared much higher in two small observational studies (n=19): 6-20%. The aim of this study is to analyze the frequency and underlying mechanism of cardiac arrhythmias in a larger group of 50 people with refractory epilepsy with Reveal XT. In the future, this may help us to identify those epilepsy patients at high risk of cardiac arrhythmias, so that we can timely institute preventive measures (e.g. pacemaker implantation).

NCT ID: NCT01945762 Completed - Clinical trials for Symptomatic, Aggressive, Sporadic, Unresectable, Locally

Observational Study to Evaluate Vandetanib in RET -/+ Patients With Metastatic Medullary Thyroid Cancer

Caprelsa104
Start date: February 17, 2014
Phase:
Study type: Observational

This is a European multinational, multicenter, non-interventional (observational) and prospective study. It is carried on to confirm in real life conditions the benefit/risk of vandetanib (CAPRELSA™) 300 mg, both in RET negative and RET positive patients with symptomatic, aggressive, sporadic, unresectable, locally advanced/metastatic MTC.

NCT ID: NCT01945606 Completed - Heart Failure Clinical Trials

Study to Assess the Safety of BAY1067197 in Stable Heart Failure Patients on Standard Therapy Including ß-blocker

Start date: November 29, 2013
Phase: Phase 2
Study type: Interventional

This is a study to investigate the safety and tolerability of the partial A1 agonist BAY1067197 in patients with chronic heart failure. BAY1067197 will be applied as a single dose of 30 mg in addition to standard therapy including a beta-blocker. The aim of the study is to assess if a single oral dose of 30 mg BAY1067197 is well tolerated when given on top of standard therapy for heart failure, particularly ß-blocker treatment.

NCT ID: NCT01945593 Completed - Hemophilia A Clinical Trials

BAX 855 Continuation

Start date: October 15, 2013
Phase: Phase 3
Study type: Interventional

To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.

NCT ID: NCT01944228 Completed - Inflammation Clinical Trials

Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study

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

The purpose of this study is to assess the effect of transvenous vagus nerve stimulation (tVNS) on the immune response. In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide [LPS]) elicits a systemic immune response with release of pro-inflammatory cytokines, such as TNF α. This trial will determine if an anti-inflammatory effect can be produced by acute VNS using a minimally invasive delivery method.

NCT ID: NCT01942135 Completed - Clinical trials for Metastatic Breast Cancer

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

Start date: September 26, 2013
Phase: Phase 3
Study type: Interventional

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).