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NCT ID: NCT02100722 Active, not recruiting - Coronary Disease Clinical Trials

A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients With Multivessel Coronary Artery Disease

FAME 3
Start date: August 25, 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Fractional flow reserve (FFR, (coronary pressure wire-based index for assessing the ischemic potential of a coronary lesion)-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (CAD) will result in similar outcomes to coronary artery bypass graft surgery (CABG).

NCT ID: NCT02075840 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

ALEX
Start date: August 19, 2014
Phase: Phase 3
Study type: Interventional

This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.

NCT ID: NCT02018744 Active, not recruiting - Clinical trials for Safety and Performance of the Nellix Endovascular Sealing System

Nellix® Registry Study: EVAS-Global

EVAS-FORWARD 1
Start date: October 2013
Phase:
Study type: Observational [Patient Registry]

This registry has been designed as a multicenter, single arm, open label, post-market registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed up to discharge discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment). This registry of the Nellix System, which has received the market authorization of the European Union (Conformité Européenne, CE-certification) in a "real world" patient population treated in a multicenter setting will provide an assessment of the generalizability of the approach and System. Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the study.

NCT ID: NCT02003924 Active, not recruiting - Prostate Cancer Clinical Trials

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer

PROSPER
Start date: October 31, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

NCT ID: NCT01983241 Active, not recruiting - Clinical trials for Pulmonary Emphysema in Alpha-1 PI Deficiency

Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

SPARTA
Start date: November 2013
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of an optional pre-screening phase, Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.

NCT ID: NCT01962441 Active, not recruiting - Hepatitis C Clinical Trials

SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection

Start date: September 2013
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+peginterferon alfa-2a (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.

NCT ID: NCT01954628 Active, not recruiting - COPD Clinical Trials

Efficacy and Safety of AQX-1125 in Unstable COPD

FLAGSHIP
Start date: October 2013
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the effect of 12 weeks of treatment with once daily administration of AQX-1125 compared to placebo in subjects following exacerbations of Chronic Obstructive Pulmonary Disease (COPD) by targeting the SHIP1 (Src Homology 2-containing Inositol-5'-Phosphatase 1) pathway.

NCT ID: NCT01946204 Active, not recruiting - Prostatic Neoplasms Clinical Trials

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

SPARTAN
Start date: October 14, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

NCT ID: NCT01939249 Active, not recruiting - Clinical trials for Coronary Artery Disease

Prospective, Randomized, Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus-eluting Stent

BIOFLOW-IV
Start date: September 2013
Phase: N/A
Study type: Interventional

BIOFLOW-IV is a prospective, international, multicenter, randomised controlled trial. The purpose of this trial is to compare the Biotronik Orsiro drug eluting stent system with the Xience Prime / Xience Xpedition (Xience)drug eluting stent system in de novo coronary lesions. The study is powered for non-inferiority with respect to Target Vessel Failure(TVF)at 12 months.

NCT ID: NCT01924819 Active, not recruiting - Gastric Cancer Clinical Trials

Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma

TOPGEAR
Start date: September 2009
Phase: Phase 2/Phase 3
Study type: Interventional

Gastric cancer remains a significant global public health problem. Although in developed countries its incidence has dramatically decreased, on a worldwide scale it is still a leading cause of cancer-related deaths. Surgery is the only potentially curative treatment for gastric cancer. Although the survival rates for patients with early stage disease (stage 1A and 1B) are good, this subgroup of patients constitutes only 20% of those undergoing resection. The majority of patients will have locally advanced or metastatic disease at presentation, which has an extremely poor prognosis. The current five-year survival rate for gastric cancer in Western countries is approximately 20-30%, a figure that has improved little over the past 30 years. The intervention arm in TOPGEAR consists of pre-operative chemotherapy, pre-operative chemoradiotherapy, surgery and post-operative chemotherapy. The control arm consists of pre-operative chemotherapy, surgery and post-operative chemotherapy. The primary objective of TOPGEAR is to investigate whether the addition of chemoradiotherapy to chemotherapy is superior to chemotherapy alone in the neoadjuvant setting by improving pathological complete response rates in the first instance, and subsequently overall survival, in patients undergoing adequate surgery (D1+ dissection) for resectable gastric cancer.