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NCT ID: NCT02698956 Completed - Aortic Stenosis Clinical Trials

SOURCE 3: Observational Study to Evaluate Safety and Performance of SAPIEN 3 THV System in Real Life Practice

SOURCE 3
Start date: July 2014
Phase:
Study type: Observational

This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites. 300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.

NCT ID: NCT02698670 Completed - Cardiac Arrhythmias Clinical Trials

Prospective Registry on User Experience With The Mapping System For Ablation Procedures

TRUE-HD
Start date: May 25, 2016
Phase: N/A
Study type: Observational [Patient Registry]

This is an observational, prospective, non-randomized, multicenter, post approval study being conducted in the United States, Europe and Asia-Pacific Regions.

NCT ID: NCT02698475 Completed - Psoriasis Clinical Trials

An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age

CADMUS Jr
Start date: May 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (>=) 6 through less than (<) 12 years with moderate to severe chronic plaque psoriasis

NCT ID: NCT02697032 Completed - Breast Cancer Clinical Trials

FDHT PET and Bicalutamide in Metastatic Breast Cancer

Start date: February 2016
Phase: Phase 2
Study type: Interventional

Rationale: The purpose is to evaluate whether non-invasive in vivo imaging of androgen receptor (AR) presence in metastatic breast cancer patients by means of 18F-fluoro-dihydrotestosterone positron emission tomography (FDHT-PET) can be used to predict (early) treatment response to, and optimal dosing of, the anti androgen bicalutamide. The ultimate goal is to contribute to optimal selection of breast cancer patients for anti androgen treatment. Objective: Feasibility to detect a diffrence in uptake on 18F-FDHT scan after 6 weeks of treatment with bicalutamide in metastatic breast cancer patients. Secondary Objectives: to describe whether changes in 18F-FDHT tracer uptake after six weeks associates with response to bicalutamide, to describe whether changes in AR availability are different for breast cancer subgroups during treatment with bicalutamide and to describe whether 18F-FDHT tracer uptake is influenced by the amount of AR tumor expression. Study design: This is a single arm, one stage feasibility study, which will be executed in the University Medical Center Groningen, The Netherlands. The primary endpoint of the study is to evaluate the difference in 18F-FDHT uptake in tumor lesions after 6 weeks of bicalutamide treatment in patients with AR-positive metastatic breast cancer. Patients will be treated with bicalutamide until progression or unacceptable toxicity is encountered. Study population: The investigators will include 20 postmenopausal metastatic breast cancer patients with an AR positive, HER2 negative tumor. Patients should be restaged clinically with bone scintigraphy and CT scan within a 6 week timeframe of the PET examinations. Intervention: All patients will receive a baseline FDHT-PET scan and start with bicalutamide treatment 150mg daily. During follow-up patients will receive one FDHT-PET scan after 6 weeks. Treatment with bicalutamide will continue until progression or unacceptable toxicity is encountered. Main study endpoint: The percent difference in 18F-FDHT uptake in tumor lesions after 6 weeks of monotherapy bicalutamide. A minimum decrease of 20% in 18F-FDHT uptake after 6 weeks compared to baseline uptake with an α of 0.05 and a power of 80%, is considered clinical significant.

NCT ID: NCT02696967 Completed - Clinical trials for Chronic Stable Heart Failure

A Study of CLR325 in Chronic Stable Heart Failure Patients.

Start date: May 17, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the safety and tolerability of CLR325 intravenous (i.v.) infusion in patients with stable heart failure to determine if further clinical development of the drug in this indication was warranted.

NCT ID: NCT02696798 Completed - Spondyloarthritis Clinical Trials

A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis

COAST-W
Start date: April 12, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).

NCT ID: NCT02696785 Completed - Spondyloarthritis Clinical Trials

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

COAST-V
Start date: May 2, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).

NCT ID: NCT02696031 Completed - Clinical trials for Non-radiographic Spondyloarthritis

Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis

PREVENT
Start date: April 29, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

NCT ID: NCT02694497 Completed - Clinical trials for Chlamydia Trachomatis Infection

Transmission of Genital and Extra-genital Chlamydia Trachomatis Infections in Women

FemCure
Start date: April 2016
Phase:
Study type: Observational

Multicenter prospective cohort study in Chlamydia trachomatis positive women after regular treatment to understand the transmission of anorectal CT infections.

NCT ID: NCT02693210 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate the Efficacy and Safety of Mabthera Alone and in Combination With Either Cyclophosphamide or Methotrexate in Patients With Rheumatoid Arthritis

Start date: February 2001
Phase: Phase 2
Study type: Interventional

WA16291 is a Phase IIa "proof-of-concept" study. The primary objective of this study is to determine the safety and efficacy of rituximab (a B cell depleting chimeric monoclonal antibody) used either as monotherapy or in combination with methotrexate or cyclophosphamide in participants with rheumatoid arthritis who have failed prior Disease Modifying Anti-Rheumatic Drug (DMARD) therapy and currently have an inadequate clinical response to methotrexate.