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NCT ID: NCT01960699 Completed - Clinical trials for Cardiac Arrest With Successful Resuscitation

Proteomic Profiling to Reveal Novel Prognostic Markers for Neurological Outcome Following Resuscitation

Start date: October 2013
Phase:
Study type: Observational [Patient Registry]

Background: Cardiac arrest is a life-threatening event. Intensivists are challenged with an increasing number of patients with uncertain neurological outcome following cardiopulmonary resuscitation (CPR). The prognostic value of current biomarkers for neurophysiologic long-term outcome is limited. Hypothesis: We hypothesize that specific brain-derived tissue leakage proteins can be identified to reveal novel, more reliable prognostic biomarkers for good neurological outcome. Methods: This translational study (n=100) is a combination of a prospective basic science study intended to reduce the number of potential plasma biomarker candidates by proteomic shotgun analyses in brain tissue autopsy samples and plasma samples from resuscitated patients (n=10) and a prospective clinical validation study in a large study population (n=90) by high-throughput analyses. Selection of proteomic markers and signature estimation will be performed to discriminate patients with good and poor outcome. Clinical perspective: A structured proteomic analysis approach might identify the best marker out of all proteins liberated during cellular damage.

NCT ID: NCT01959451 Completed - Clinical trials for Acute Coronary Syndrome

Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment For Acute Coronary Syndromes Trial

TROPICAL-ACS
Start date: September 2013
Phase: Phase 4
Study type: Interventional

This study investigates whether a platelet function testing guided approach with a short-term (1 week) prasugrel treatment and a switch over to clopidogrel treatment in adequate responders to clopidogrel is non-inferior regarding the combined incidence of bleeding and thrombotic complications to a 12 month standard treatment with prasugrel in acute coronary syndrome (ACS) patients treated with percutaneous coronary intervention (PCI).

NCT ID: NCT01958918 Completed - Clinical trials for Neovascular Age-related Macular Degeneration

Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD

SALT
Start date: October 23, 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.

NCT ID: NCT01958021 Completed - Clinical trials for Advanced, Metastatic Breast Cancer

Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)

MONALEESA-2
Start date: December 17, 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo controlled trial.

NCT ID: NCT01957202 Completed - Clinical trials for Rhinitis, Allergic, Perennial and Seasonal

A Proof of Concept Study to Assess Effect of Fluticasone Furoate (FF)/Levocabastine Fixed Dose Combination (FDC) Compared With Levocabastine and FF Alone in Subjects With Allergic Rhinitis (AR)

Start date: October 2013
Phase: Phase 2
Study type: Interventional

This study will be a randomised, double blind, placebo controlled, 3-way, incomplete block crossover study to evaluate the effect of single and repeat doses of levocabastine, FF, placebo and a FDC of FF/levocabastine administration in AR subjects. The total expected study duration for each individual participating in the study will be a maximum of up to 20 weeks (including the screening and follow-up). This will be a three period study and subjects will be assigned to a sequence of three treatments. There will be a wash-out period of 14-28 days between two treatment periods. The rational for this study is to demonstrate proof of concept with the FDC of FF and levocabastine compared with each of the components administered alone.

NCT ID: NCT01955811 Completed - Blood Clotting Clinical Trials

Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion

FiT2012
Start date: December 2012
Phase: Phase 4
Study type: Interventional

Patients with need of platelet transfusion for any reason will participate in this study. Directly before the start of infusion and one hour after the end of platelet transfusion blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion will be compared. The study hypothesis is that treatment with Fibrinogen results in a better stabilisation of blood coagulation.

NCT ID: NCT01954394 Completed - Clinical trials for Hypercholesterolemia

Open Label Study of Long Term Safety Evaluation of Alirocumab

ODYSSEY OLE
Start date: December 17, 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives: - To evaluate the long-term efficacy of alirocumab on lipid parameters. - To evaluate the long-term immunogenicity of alirocumab.

NCT ID: NCT01951638 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)

Start date: November 6, 2013
Phase: Phase 2
Study type: Interventional

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard diuretic and comorbidity treatment for heart failure with preserved ejection fraction (HFpEF)

NCT ID: NCT01951625 Completed - Heart Failure Clinical Trials

Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)

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

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).

NCT ID: NCT01950819 Completed - Hemodialysis Clinical Trials

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

TRANSFORM
Start date: December 3, 2013
Phase: Phase 4
Study type: Interventional

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.