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NCT ID: NCT01732913 Terminated - Clinical trials for Indolent Non-Hodgkin's Lymphomas

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Yosemite
Start date: January 16, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

NCT ID: NCT01732770 Completed - Clinical trials for Post Menopausal Osteoporosis

Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis

Start date: November 7, 2012
Phase: Phase 4
Study type: Interventional

This study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (BMD) at various skeletal sites.

NCT ID: NCT01730937 Active, not recruiting - Clinical trials for Advanced Adult Primary Liver Cancer

Sorafenib Tosylate With or Without Stereotactic Body Radiation Therapy in Treating Patients With Liver Cancer

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

This randomized phase III trial studies sorafenib tosylate and stereotactic body radiation therapy to see how well they work compared to sorafenib tosylate alone in treating patients with liver cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy may be able to send the radiation dose directly to the tumor and cause less damage to normal tissue. Giving sorafenib tosylate together with stereotactic body radiation therapy may kill more tumor cells.

NCT ID: NCT01730807 Completed - Atrial Flutter Clinical Trials

IntellaTip MiFi XP Ablation Catheter Trial

MiFi-CTI
Start date: March 2013
Phase: N/A
Study type: Interventional

A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.

NCT ID: NCT01730534 Completed - Clinical trials for Diabetes Mellitus, Non-Insulin-Dependent

Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

DECLARE-TIMI58
Start date: April 25, 2013
Phase: Phase 3
Study type: Interventional

This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

NCT ID: NCT01730248 Terminated - Myelofibrosis Clinical Trials

A Study to Find the Maximum Tolerated Dose of the Experimental Combination of the Drugs INC424 and BKM120 in Patients With Primary or Secondary Myelofibrosis

Start date: December 18, 2012
Phase: Phase 1
Study type: Interventional

The purpose of this phase Ib clinical trial is to evaluate the safety of the combination of INC424 and BKM120 in the myelofibrosis population and to establish the maximum tolerated dose and or the Recommended Phase II dose of the combination guided by the Bayesian dose escalation model. INC424 has shown efficacy in myelofibrosis (MF) and is approved in the US and EU for the treatment of MF. BKM120 is a PI3K inhibitor. Preclinical and early clinical experience support inhibition of the PI3K/mTOR pathway in MF as aberrant activation of the pathway has been observed in MF models and may contribute to the pathogenesis of the disease.

NCT ID: NCT01730053 Completed - Clinical trials for Hypercholesterolemia

Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)

Start date: November 30, 2012
Phase: Phase 3
Study type: Interventional

To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.

NCT ID: NCT01730040 Completed - Clinical trials for Hypercholesterolemia

Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)

Start date: October 2012
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).

NCT ID: NCT01728805 Completed - Clinical trials for Cutaneous T-Cell Lymphoma

Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL

Start date: November 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.

NCT ID: NCT01728558 Completed - Clinical trials for Critical Illness and Mechanical Ventilation

Early Goal-Directed Sedation Compared With Standard Care in Mechanically Ventilated Critically Ill Patients

SPICE III RCT
Start date: November 2013
Phase: Phase 3
Study type: Interventional

The Use of sedative drugs in intensive care is widespread. A cohort study conducted in Australia and New Zealand in 2010 revealed a high prevalence of deep sedation within the first 48 hours of mechanical ventilation which was independently linked to prolonged ventilation, hospital and 180 days mortality. Clinical practice is moving towards the use of lighter levels of sedation. Recent RCTs in Europe (JAMA 2012) and previous RCTs (JAMA 2009) supports growing evidence that dexmedetomidine facilitates rousable sedation, shortens ventilation time and attenuates delirium when compared to midazolam and propofol. The investigators confirmed in a pilot study the feasibility, efficacy and safety of a process of care known as Early Goal Directed Sedation (EGDS) that delivers: 1. Early randomization after intubation or arrival in the ICU (intubated). 2. Early Adequate analgesia after randomization. 3. Goal directed sedation titrated to achieve light sedation. 4. Dexmedetomidine based algorithm as the primary sedative agent with avoidance of benzodiazepines. The aim of this study is to assess the effectiveness of Early Goal Directed Sedation when compared to standard care sedation in critically ill patients. The study hypothesis is that Early Goal-Directed Sedation (EGDS), compared to standard care sedation, reduces 90-day all-cause mortality in critically ill patients who require mechanical ventilation.