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NCT ID: NCT03280550 Completed - Nasal Polyps Clinical Trials

A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

POLYP 1
Start date: November 15, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39855 (POLYP 2; NCT03280537) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.

NCT ID: NCT03280433 Recruiting - Clinical trials for Coronary Artery Disease

Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study

EPICHEART
Start date: September 1, 2014
Phase: N/A
Study type: Observational

This translational study was designed to explore the association of the quantity and quality of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling and postoperative atrial fibrillation in a high cardiovascular disease-risk population. The investigators expect to identify new biochemical factors and biomarkers in the crosstalk between the epicardial adipocytes, coronary plaques and atrial cardiomyocytes that are involved in the pathogenesis of atherosclerosis and atrial fibrillation, respectively.

NCT ID: NCT03279484 Active, not recruiting - Clinical trials for Arrythmia, Implatable Cardioverter Defibrillation, Lead

Safety and Electrical Performances Evaluation of Navigo Leads Equipped With IS4 Connector

NAVIGATOR
Start date: November 24, 2017
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the safety and electrical performance of Left ventricular (LV) NAVIGO 4LV leads, pre-shaped (S-shaped&U-shaped: NAVIGO 4LV 2D, NAVIGO 4LV ARC) and Straight (NAVIGO 4LV PILOT), with IS4 connector

NCT ID: NCT03276143 Completed - Clinical trials for Knee Arthroplasty, Total

FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty

FOXTROT
Start date: September 21, 2017
Phase: Phase 2
Study type: Interventional

This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of BAY1213790. This means that it was known which treatment was given, but it was not known which dose of BAY1213790 was administered.

NCT ID: NCT03271957 Not yet recruiting - Clinical trials for Manual Rotation of A Liveborn

Manual Rotation in Persistent Occiput Posterior Position

Start date: October 1, 2017
Phase: N/A
Study type: Observational

Is part of routine obstetric care to attempt a manual rotation in all fetus that are in a persistent OP at delivery. Nevertheless, little is known about the success of this intervention or about the relation of some ultrasound measures with the outcome.

NCT ID: NCT03269175 Completed - Multiple Sclerosis Clinical Trials

BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies

Start date: September 29, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to obtain long-term clinical data from patients approximately 15 years after their first clinical event, who participated in the former BENEFIT 304747 study and were treated at least once within that study. This study will collect clinical information on the disease course, on disability, relapses, cognitive function over time, quality of life, depression, fatigue, resource use, and employment status. In addition, brain MRI is performed.

NCT ID: NCT03262753 Recruiting - Arterial Stiffness Clinical Trials

Long-term Outcomes and Vascular Evaluation After Coarctation of the Aorta Treatment

LOVE-COARCT
Start date: June 1, 2013
Phase: N/A
Study type: Observational

Background: Coarctation of the aorta (CoA) can be treated using surgery, balloon angioplasty or stent implantation. Although short-term results are excellent with all three treatment modalities, long term cardiovascular (CV) morbidity and mortality remain high, likely due to persistently abnormal vascular function. The effects of treatment modality on long term vascular function remain uncharacterized. The goal of this study is to assess vascular function in this patient population for comparison among the treatment modalities. Methods: Vascular function in large and small arteries will be prospectively assessed fusing multiple non-invasive modalities, and the results will be compared among the three groups of CoA patients previously treated using surgery, balloon angioplasty or stent implantation after frequency matching for confounding variables. A comprehensive vascular function assessment protocol was created to be used in 7 centers. The primary outcome is arterial stiffness measured by arterial tonometry. Inclusion and exclusion criteria were carefully established after consideration of several potential confounders. Sample size was calculated for the primary outcome variable. Conclusions: Treatment modalities for CoA may have distinct impact on large and small arterial vascular function. The results of this study will help identify the treatment modality that is associated with the most optimal level of vascular function, which, in the long term may reduce CV risk.

NCT ID: NCT03260322 Completed - Clinical trials for Advanced Solid Tumors

A Multiple-dose Study of ASP8374, an Immune Checkpoint Inhibitor, as a Single Agent and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors

Start date: September 8, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the tolerability and safety profile of ASP8374 when administered as a single agent and in combination with pembrolizumab in participants with locally advanced (unresectable) or metastatic solid tumor malignancies. Also primary purpose is to characterize the pharmacokinetic profile of ASP8374 when administered as a single agent and in combination with pembrolizumab. Last primary purpose of this study is to determine the recommended Phase 2 dose (RP2D) of ASP8374 when administered as a single agent and in combination with pembrolizumab. The secondary purpose of this study is to evaluate the anti-tumor effect (objective response rate [ORR], duration of response [DOR], persistence of response after discontinuation, and disease control rate [DCR]) of ASP8374 when administered as a single agent and in combination with pembrolizumab. NTP: Neutropenia NHAE:Non-haematological AE GBS: Guillain-Barré syndrome"" IRR: Infusion-related reaction AST: Aspartate aminotransferase ALT: Alanine aminotransferase MS/MG: Myasthenia Syndrome/Myasthenia Gravis TRT: Treatment-related Toxicity TCP: Thrombocytopenia

NCT ID: NCT03259308 Terminated - Ulcerative Colitis Clinical Trials

Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis

FIGARO UC 302
Start date: December 5, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03259074 Completed - Clinical trials for Ankylosing Spondylitis

Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)

SURPASS
Start date: November 30, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).