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NCT ID: NCT02189837 Completed - Clinical trials for Primary Hyperlipidemia and Mixed Dyslipidemia

Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody

FLOREY
Start date: July 8, 2014
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled trial to evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics.

NCT ID: NCT02189109 Completed - Clinical trials for Glioblastoma Multiforme

The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma

GBM
Start date: May 2014
Phase: Phase 1
Study type: Interventional

This clinical trial is testing the safety, tolerability and effectiveness of NVX-108 administered via intravenous infusion in combination with standard radiation and chemotherapy. NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.

NCT ID: NCT02187861 Completed - Follicular Lymphoma Clinical Trials

A Study Evaluating the Safety and Efficacy of Venetoclax (GDC-0199) Plus Bendamustine + Rituximab (BR) in Comparison With BR or Venetoclax Plus Rituximab in Participants With Relapsed and Refractory Follicular Non-Hodgkin's Lymphoma (fNHL)

Start date: December 1, 2014
Phase: Phase 2
Study type: Interventional

This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.

NCT ID: NCT02187159 Completed - Clinical trials for Pain Associated With Fibromyalgia

Treatment of Pain Associated With Fibromyalgia

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

The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo. Weekly ADPS is based on daily pain scores reported by the participant that best describes his or her worst pain over the previous 24 hours.

NCT ID: NCT02187120 Completed - Wounds and Injuries Clinical Trials

Pre-hospital Anti-fibrinolytics for Traumatic Coagulopathy and Haemorrhage (The PATCH Study)

PATCH
Start date: July 28, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this research is to determine whether giving severely injured adults a drug called tranexamic acid (TXA) as soon as possible after injury will improve their chances of survival and their level of recovery at six months. After severe injury, a person may have uncontrolled bleeding that places them at high risk of bleeding to death. Coagulation (the formation of blood clots) is an important process in the body that helps to control blood loss. Up to a quarter of people that are severely injured have a condition called acute traumatic coagulopathy. This condition affects coagulation and results in the break down of blood clots (fibrinolysis) that can lead to increased blood loss and an increased risk of dying. TXA is an anti-fibrinolytic drug that might help to reduce the effects of acute traumatic coagulopathy by preventing blood clots from breaking down and helping to control bleeding. In Australia, TXA is approved for use by the Therapeutic Goods Administration (TGA) to reduce blood loss or the need for blood transfusion in patients undergoing surgery (i.e. cardiac surgery, knee or hip arthroplasty). Recent evidence from a large clinical trial (CRASH-2) showed early treatment with TXA reduced the risk of death in severely injured patients, however the majority of patients involved in the study were injured in countries where prehospital care is limited and rapid access to lifesaving treatments is limited compared to that available in countries like Australia and New Zealand. It is unclear whether TXA will reduce the risk of death to the same degree when it is given alongside other lifesaving treatments that are available to patients soon after injury in these countries. The hypothesis is that TXA given early to injured patients who are at risk of acute traumatic coagulopathy and who are treated in countries with systems providing advanced trauma care reduces mortality and improves recovery at 6-months after injury.

NCT ID: NCT02187107 Completed - HIV Clinical Trials

A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials

Start date: January 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study was primarily to assess the long-term safety and tolerability of TMC114/rtv in addition to an individually optimized background antiretroviral therapy in HIV-1 infected participants. In addition, antiviral activity and immunological effect were also evaluated.

NCT ID: NCT02187055 Completed - Rhematoid Arthritis Clinical Trials

An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate

ORAL STRATEGY
Start date: August 2014
Phase: Phase 4
Study type: Interventional

To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.

NCT ID: NCT02186873 Completed - Clinical trials for Ankylosing Spondylitis

A Study of Golimumab in Participants With Active Ankylosing Spondylitis

Start date: September 3, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of intravenously (administration of a fluid into the vein) administered golimumab 2 milligram per kilogram (mg/kg) in participants with active ankylosing spondylitis (chronic inflammatory disease of unknown etiology that involves the sacroiliac joints, and often the axial skeleton, entheses, and peripheral joints).

NCT ID: NCT02184195 Completed - Clinical trials for Metastatic Adenocarcinoma of the Pancreas

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy

POLO
Start date: December 16, 2014
Phase: Phase 3
Study type: Interventional

A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy

NCT ID: NCT02182427 Completed - Malnutrition Clinical Trials

Malnutrition Clinical Characteristics Validation Study

MCC
Start date: April 2014
Phase: N/A
Study type: Observational [Patient Registry]

Malnutrition (under-nutrition) occurs in approximately 30% of hospitalized adults worldwide and results in poor outcomes. However there is no universal method for diagnosing malnutrition. A group of experts created a set of 6 characteristics to identify malnutrition. The goal of this project is to determine whether these characteristics are the best indicators to identify malnutrition or if there are other factors that may better identify malnutrition. Because there is no gold standard definition for malnutrition, the investigators will compare the characteristics against outcomes such as length of stay, hospital readmission and death. Outcomes are also influenced by disease state, therefore, information on what brought the patient to the hospital and what happened to them in the hospital will be collected that allows the investigators to separate the effect of malnutrition from disease. The hypothesis for this study is that the malnutrition clinical characteristics and diagnosis criteria, as presented by the experts, are valid and reliable principles for the diagnosis of adult under-nutrition.