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NCT ID: NCT01928875 Completed - Clinical trials for Surgical Procedure, Unspecified

Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia

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

The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in comparison to standard clinical practice during anesthesia. Adequacy of Anesthesia (AoA) monitoring comprises the use of both Entropy and SPI measurements. Adequacy of anesthesia will be monitored using non-invasive blood pressure, blood oxygen saturation (SpO2), ECG, and neuromuscular transmission (NMT).

NCT ID: NCT01926782 Completed - Clinical trials for Hypercholesterolemia

Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

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

The purpose of the study is to determine if the study drug (alirocumab)administered every 4 weeks, given by injection under the skin is effective and safe compared with placebo in lowering cholesterol, if used alone or added to the participants' current cholesterol-lowering medication.

NCT ID: NCT01925768 Completed - Psoriatic Arthritis Clinical Trials

Safety and Efficacy Study of Apremilast to Treat Psoriatic Arthritis

Start date: September 4, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether apremilast is safe and effective for treating patients with psoriatic arthritis.

NCT ID: NCT01922089 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients

TITRATION
Start date: November 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

NCT ID: NCT01921205 Completed - Epilepsy Clinical Trials

Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures

Start date: August 29, 2013
Phase: Phase 3
Study type: Interventional

Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to <17 years of age who currently have uncontrolled partial onset seizures.

NCT ID: NCT01920711 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction

Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction

PARAGON-HF
Start date: July 18, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.

NCT ID: NCT01917331 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

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

Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of Beclometasone+Formoterol+Glycopyrrolate (BDP/FF/GB) administered via pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment

NCT ID: NCT01915602 Completed - Clinical trials for Carcinoma, Hepatocellular

Refametinib in Combination With Sorafenib in RAS Mutant Hepatocellular Carcinoma (HCC)

Start date: September 27, 2013
Phase: Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement [modified response evaluation criteria in solid tumors (mRECIST)] assessed by external independent radiologists. Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.

NCT ID: NCT01915589 Completed - Clinical trials for Carcinoma, Hepatocellular

Refametinib(BAY86-9766) in RAS Mutant Hepatocellular Carcinoma (HCC)

Start date: September 16, 2013
Phase: Phase 2
Study type: Interventional

This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review. Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.

NCT ID: NCT01914393 Completed - Schizophrenia Clinical Trials

Pediatric Open-Label Extension Study

Start date: September 30, 2013
Phase: Phase 3
Study type: Interventional

This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326