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NCT ID: NCT02092922 Completed - Clinical trials for Advanced Multiple Myeloma

A Phase 2 Trial of Filanesib in Relapsed/Refractory Multiple Myeloma (AfFIRM)

Start date: May 2014
Phase: Phase 2
Study type: Interventional

The AfFIRM Study is a Phase 2 study during which patients with advanced multiple myeloma will receive single-agent investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of filanesib in treating myeloma. Approximately 160 patients from North America and Europe will be enrolled in this study. Eligible patients will have received at least two prior lines of therapy; have received prior bortezomib and lenalidomide; and have disease refractory to carfilzomib and/or pomalidomide.

NCT ID: NCT02092857 Completed - Clinical trials for Focus: Nutritional Requirements for Infants

Assessment of Arachidonic Acid Supplementation in Infant Formula on the Immune Response of Infants

Start date: December 2009
Phase: Phase 1
Study type: Interventional

The immune system of newborn infants is immature with low activity of both innate and acquired immune reactions. Early nutrition has an impact on early immune responses. Dietary fatty acids are one nutritional factor noted to play a role in immune function. The omega-6 long-chain polyunsaturated fatty acid, ARA (Arachidonic acid) and the omega-3 fatty acid, DHA (docosahexaenoic acid) are found naturally in breastmilk and some infant formulas. The balance or relative amounts of ARA and DHA have been associated with immune response. Some commercial infant formula contains both ARA and DHA. However, the optimal balance of ARA and DHA has not been determined with respect to immune function. This study will assess two levels of ARA and the impact on immune response in healthy, term infants and whether genes that influence essential fatty acid metabolism alter the nutritional requirement of infants.

NCT ID: NCT02092818 Completed - Clinical trials for Hypertension, Pulmonary

EXPERT, EXPosurE Registry RiociguaT in Patients With Pulmonary Hypertension

EXPERT
Start date: May 31, 2014
Phase:
Study type: Observational

In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.

NCT ID: NCT02092649 Completed - Clinical trials for Whole Body Energy Metabolism

Effects of 12 Weeks of Omega 3 Supplementation on Resting Metabolic Rate

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

Fatty acids are the main components of the cell membranes. It has been demonstrated that diet can alter the characteristics and function of many membranes in the body, which has an effect on cardiovascular and metabolic health. Over the last two decades there has been a substantial rise in the research of the effects of Omega 3 polyunsaturated fatty acids on bodily function. There are two fatty acids that are of particular interest to researchers, eicosapentanoic acid (EPA) and docosahexanoic acid (DHA). These fatty acids have unique unsaturated structures, and their incorporation into biological membranes seems to generate important and positive physiological effects. The body is unable to synthesize these fatty acids in high concentrations to elicit significant effects, so they must be obtained through diet in food or via supplementation. It has been suggested that EPA and DHA supplementation increases resting metabolic rate (RMR) in humans, in part by increasing the use of fat as a fuel during rest. There are a limited number of studies examining the effects of Omega 3 supplementation on RMR. Some have found an increase in RMR while others have found no change. These studies have some limitations, as that they have either used a small sample size, a low omega fatty acid dose and/or short supplementation periods. Due to the variable results, the investigators will improve the reliability of the RMR measurements by making measures on each subject during two consecutive days at each time point that it is measured (0, 6 and 12 weeks). Therefore, the purpose of this study is to determine the effects of 12 weeks of omega 3 supplementation (3 g/d) on healthy young adults vs. the supplementation of a placebo. The researchers hypothesize that EPA and DHA supplementation will result in an increase in RMR and fat oxidation in some subjects and not in others. The duplicate RMR measures will determine the prevalence and magnitude of the omega 3 supplementation.

NCT ID: NCT02092467 Completed - Clinical trials for Arthritis, Rheumatoid

Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis

Start date: March 14, 2014
Phase: Phase 4
Study type: Interventional

This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.

NCT ID: NCT02091999 Completed - Clinical trials for Metastatic Urothelial Cancer and Other Malignant Solid Tumors

A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4

Start date: May 14, 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and pharmacokinetics of enfortumab vedotin as well as assess the immunogenicity and antitumor activity in subjects with metastatic urothelial cancer and other malignant solid tumors that express Nectin-4.

NCT ID: NCT02091960 Completed - Clinical trials for Advanced Breast Cancer

A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer

Start date: September 5, 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.

NCT ID: NCT02091583 Completed - Metabolic Syndrome Clinical Trials

Canola Oil, Fibre and DHA Enhanced Clinical Trial

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

The purpose of this study is to examine the effects of consumption of a novel food supplement consisting of Canola Oil, Fibre and DHA, containing the most effective food bioactives, including n-3 fatty acid enriched dietary oil high in monounsaturated fatty acids (MUFAs) and soluble dietary fibre, aiming at the management of heart disease risk factors in people with metabolic syndrome and to test its efficacy and safety in humans.

NCT ID: NCT02091570 Completed - Satiety Clinical Trials

Effect of Nutrition Bars on Satiety in Women

Start date: December 17, 2013
Phase: N/A
Study type: Interventional

This study investigates nutrition bar consumption and possible impact on self-reported ratings of hunger and fullness compared to a control.

NCT ID: NCT02091011 Completed - Clinical trials for Implantable Cardioverter Defibrillators

LONGEVITY Study. Evaluation of the Device and Battery Longevity of Boston Scientific Market-released ICD and CRT-D Devices

Start date: January 27, 2014
Phase:
Study type: Observational

The study is to determine the rate and cause of device replacements at 5 years post-implantation. It will assess the battery and device longevity of the Implantable Cardioverter Defibrillators (ICD) and CRT-D Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices. It will also validate the device survival information given in Boston Scientific's Product Performance Report by comparing the pulse generator (PG) survival probability in the study to that presented in the Product Performance Reports (PPR)