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NCT ID: NCT02832544 Completed - Clinical trials for Rheumatic Heart Disease

INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies, Non-Inferiority

INVICTUS-VKA
Start date: August 22, 2016
Phase: Phase 3
Study type: Interventional

This program is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), Atrial fibrillation (AF)/flutter and stroke. A prospective, randomized, parallel group, open-label clinical trial of rivaroxaban versus standard vitamin K antagonists (VKA) therapy to evaluate non-inferiority of rivaroxaban to VKA, with testing for superiority if non-inferiority is satisfied.

NCT ID: NCT02670460 Completed - Clinical trials for Ventilator Induced Lung Injury

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial

Start date: October 2015
Phase: N/A
Study type: Interventional

Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.

NCT ID: NCT02607527 Completed - Clinical trials for Mitral Valve Insufficiency

Annular Reshaping of the Mitral Valve for Patients With Mitral Regurgitation Using the Millipede IRIS System

Start date: May 8, 2017
Phase: N/A
Study type: Interventional

Multi center evaluation of the Millipede IRIS for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.

NCT ID: NCT02278913 Completed - Diabetes Clinical Trials

Basal Bolus Versus Human Insulin in Hospitalized Patients With Diabetes in Paraguay

Start date: April 2009
Phase: Phase 4
Study type: Interventional

Few randomized studies have focused on the optimal management of non-ICU patients with type 2 diabetes in Latin America. Objective: Compare safety and efficacy of a basal bolus regimen with analogs and human insulins in general medicine patients admitted to a University Hospital in Asuncion, Paraguay.

NCT ID: NCT02268045 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Study of RTXM83 Plus CHOP Chemotherapy Versus a Rituximab Plus CHOP Therapy in Patients With Non Hodgkin's Lymphoma

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

This is a multicenter, double-blind, randomized study comparing the efficacy, pharmacokinetics (PK)/pharmacodynamics (PD), safety and immunogenicity profile of RTXM83 (rituximab biosimilar) vs reference rituximab (MabThera®), both with CHOP, as first-line treatment of Diffuse-Large-B-Cell-Lymphoma (DLBCL). Rituximab biosimilar and MabThera® were both administered intravenously on Day 1 of each 3-week cycle with CHOP chemotherapy for six cycles. Two additional cycles of treatment were permitted at the Investigator's discretion. Patients were followed up for 9 months after last study dose.

NCT ID: NCT02156609 Completed - Clinical trials for High Risk Percutaneous Coronary Intervention

HeartMate PHP™ CE Mark Clinical Investigation Plan

HM PHP CE Mark
Start date: June 2014
Phase: N/A
Study type: Interventional

The HeartMate PHP is a catheter-based pump designed to provide partial left heart circulatory support. The study will assess the safety and performance of the HeartMate PHP in supporting patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing percutaneous coronary interventions (PCI), such as coronary stent placement.

NCT ID: NCT02150980 Completed - Clinical trials for Fractures or Dislocations

INternational ORthopaedic MUlticenter Study in Fracture Care (INORMUS)

INORMUS
Start date: April 2014
Phase:
Study type: Observational

Background: Worldwide, injuries from trauma represent a major public health problem. The World Health Organization (WHO) has deemed this problem as one of the most important global priorities, calling 2011-2020 the 'Decade of Action for Road Safety'. Despite this, there is little empirical data in low and middle-income countries quantifying the burden of musculoskeletal injuries. Methods: INORMUS is a global, prospective, multi-center, observational cohort study. The primary objective of the study is to determine the mortality, re-operation and infection rates of musculoskeletal trauma patients within 30 days post-hospital admission. The INORMUS study seeks to enroll 40,000 patients from low-middle income countries in Africa, Asia, and Latin America.

NCT ID: NCT02119845 Completed - Clinical trials for Chronic Kidney Disease (CKD)

A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001

Start date: August 2012
Phase: N/A
Study type: Interventional

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) in patients requiring chronic hemodialysis.

NCT ID: NCT02119832 Completed - Clinical trials for Chronic Kidney Disease (CKD)

A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol Flex-1-002-IR Intervention Reduction (IR)

Start date: April 2013
Phase: N/A
Study type: Interventional

The primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the FLEX-1 device for the creation of an arteriovenous fistula (AVF) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.

NCT ID: NCT02044003 Completed - Clinical trials for Peripheral Artery Disease

Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair

Start date: December 2009
Phase: N/A
Study type: Interventional

The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.