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NCT ID: NCT02332590 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety of Sarilumab and Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (SARIL-RA-MONARCH)

Start date: January 28, 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy with respect to signs and symptoms as assessed by disease activity score 28 (DAS28)-erythrocyte sedimentation rate (ESR) in participants with active rheumatoid arthritis (RA) who were either intolerant of, or considered inappropriate candidates for continued treatment with methotrexate (MTX), or after at least 12 weeks of continued treatment with MTX, were determined to be inadequate responders. Secondary Objectives: To demonstrate that sarilumab monotherapy was superior to adalimumab monotherapy in participants with active RA who were either intolerant of, or considered inappropriate candidates for continued treatment with MTX, or after at least 12 weeks of continued treatment with MTX, were determined to be inadequate responders, with respect to: - Reduction of signs and symptoms of RA. - Improvement in quality of life assessed by participant reported outcome questionnaires. Assessment of the safety and tolerability of sarilumab monotherapy (including immunogenicity) throughout the study.

NCT ID: NCT02332330 Completed - Clinical trials for Coronary Artery Bypass Surgery

CD0104 VEST II Post Marketing Surveillance Study

VEST II
Start date: January 2015
Phase: N/A
Study type: Interventional

This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.

NCT ID: NCT02331264 Completed - Cardiomyopathy Clinical Trials

Cardiac Assessment of Patients With Hip Implants

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

PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on cardiac function STUDY OUTCOME MEASURES To assess the effect of metal ions from hip implants on cardiac function as measured by Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. This involves the surrogate detection of cobalt ion deposition within cardiac tissues and assessment of ejection fraction and tissue characterization (with and without contrast). STUDY IMPACT With 60,000 patients having a metal on metal (MOM) hip implant in the United Kingdom (UK), and over a million worldwide, there is need to clarify this important question, which is the source of significant concern amongst patients and surgeons alike. Also, this problem is not unique to MOM hips since all hip implants contain metal and as seen in various case reports high blood cobalt levels have arisen after catastrophic failure (e.g. fracture of a ceramic bearing surface) leading to abnormal wear of the implant and release of metal ions into the body. In the UK, over 80,000 hip implants are inserted annually.

NCT ID: NCT02330926 Completed - Neoplasms Clinical Trials

Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy

MENAC
Start date: April 2015
Phase: Phase 3
Study type: Interventional

Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment. There is an urgency for improving management, but there is no consensus on the optimal treatment for cancer cachexia. Several single therapies for cancer cachexia have been examined in clinical trials, with disappointing overall results. As multiple factors are responsible for the development of cachexia, it has been argued that optimal cachexia interventions should target all components: multimodal therapy for a multimodal problem. The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory. From a patient perspective a short term effect will be to improve physical and psychological function, to reduce symptom burden and to improve survival. In other words live a longer and better life during and after chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of weight and muscle loss, and improved physical activity and quality of life.

NCT ID: NCT02329327 Completed - Bleeding Clinical Trials

A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)

Start date: April 10, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.

NCT ID: NCT02328820 Completed - Clinical trials for Coronary Artery Disease

Combined Pressure and Flow Measurements to Guide Treatment of Coronary Stenoses

DEFINE-FLOW
Start date: October 2014
Phase: N/A
Study type: Interventional

This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be treated with percutaneous coronary intervention (PCI).

NCT ID: NCT02327624 Completed - Clinical trials for Coronary Artery Disease

STEEL Percutaneous Coronary Intervention

STEEL-PCI
Start date: June 2015
Phase: Phase 4
Study type: Interventional

The principal hypothesis of this study is that two different maintenance regimens of ticagrelor are safe, tolerable and associated with significant inhibition of erythrocyte adenosine reuptake compared to clopidogrel in patients undergoing elective Percutaneous Coronary Intervention (PCI) for stable Coronary artery disease (CAD).

NCT ID: NCT02327169 Completed - Clinical trials for Advanced Nonhematologic Malignancies

A Study MLN2480 in Combination With MLN0128 or Alisertib, or Paclitaxel, or Cetuximab, or Irinotecan in Adult Participants With Advanced Nonhematologic Malignancies

Start date: January 14, 2015
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to determine the safety profile and the maximum tolerated doses (MTDs)/ potential recommended phase 2 doses (RP2Ds) of the combination treatments of MLN2480 + MLN0128, MLN2480 + alisertib, MLN2480 + paclitaxel, MLN2480 + cetuximab, and MLN2480 + irinotecan in participants with advanced nonhematologic malignancies.

NCT ID: NCT02327143 Completed - Healthy Volunteers Clinical Trials

A Study of LY2835219 in Healthy Participants

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The aim of this study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and as an intravenous infusion (given directly into a vein via a small needle). The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function. The study will last about 10 days. Screening is required within 28 days before study drug is given.

NCT ID: NCT02327078 Completed - Lung Cancer Clinical Trials

A Study of the Safety, Tolerability, and Efficacy of Epacadostat Administered in Combination With Nivolumab in Select Advanced Cancers (ECHO-204)

Start date: November 26, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open label study. Phase 1 consists of 2 parts. Part 1 is a dose-escalation assessment of the safety and tolerability of epacadostat administered with nivolumab in subjects with select advanced solid tumors and lymphomas. Part 2 will evaluate the safety and tolerability of epacadostat in combination with nivolumab and chemotherapy in subjects with squamous cell carcinoma of head and neck (SCCHN) and non-small cell lung cancer (NSCLC). Phase 2 will include expansion cohorts in 7 tumor types, including melanoma, NSCLC, SCCHN, colorectal cancer, ovarian cancer, glioblastoma and diffuse large B-cell lymphoma (DLBCL).