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NCT ID: NCT02957617 Terminated - Clinical trials for Neuropathic Pain From Lumbosacral Radiculopathy

Extension Study to Evaluate the Long-Term Safety, Tolerability, and Maintenance of Effect of BIIB074

RELAY-1 Extend
Start date: February 10, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB074 in participants with neuropathic Pain From Lumbosacral Radiculopathy (PLSR). A secondary objective is to investigate the maintenance of effect during long-term treatment with BIIB074 in participants with neuropathic PLSR. For all efficacy assessments, baseline will be prior to randomization into Study 1014802-203. Another secondary objective is to evaluate the impact of treatment with BIIB074 on quality of life (QoL).

NCT ID: NCT02956837 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult Women

Start date: November 10, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to rank different RSV vaccine dosages of antigen (or formulations) based on safety/reactogenicity and immune response data. The formulations eliciting strong immune responses while maintaining an acceptable safety profile will be considered for further evaluation, including in studies vaccinating pregnant women.

NCT ID: NCT02946463 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start date: December 12, 2016
Phase: Phase 3
Study type: Interventional

The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).

NCT ID: NCT02944292 Recruiting - Clinical trials for Intra-abdominal Hypertension

Effect of Sedation on Intra-abdominal Pressure

Start date: November 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of deepening of sedation on intra-abdominal pressure in mechanically ventilated adult patients with intra-abdominal hypertension.

NCT ID: NCT02935244 Completed - Clinical trials for Surgical Wound Infection

Advanced Understanding of Staphylococcus Aureus Infections in Europe - Surgical Site Infections

ASPIRE-SSI
Start date: December 2016
Phase:
Study type: Observational

ASPIRE-SSI is a prospective, observational, multicentre cohort study among adult surgical patients, which aims to determine the incidence of healthcare-associated S. aureus infections, particularly S. aureus surgical site infections (SSIs), across Europe and to assess the most important risk factors for this type of infection.

NCT ID: NCT02935088 Completed - Clinical trials for Coronary Artery Disease

PRESSUREwire Study

Start date: October 12, 2016
Phase:
Study type: Observational

The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

NCT ID: NCT02928406 Completed - Clinical trials for Urinary Tract Cancer

A Study of Atezolizumab in Locally Advanced or Metastatic Urothelial or Non-Urothelial Carcinoma of the Urinary Tract

Start date: November 30, 2016
Phase: Phase 3
Study type: Interventional

This Phase IIIb, multicenter study will assess the safety of atezolizumab as second- to fourth-line treatment for participants with locally advanced or metastatic urothelial or non-urothelial cancer of the urinary tract in addition to evaluate the efficacy of atezolizumab and potential tumor biomarkers associated with atezolizumab.

NCT ID: NCT02921971 Completed - Systemic Sclerosis Clinical Trials

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Start date: December 21, 2016
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc). Secondary Objectives: - To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc. - To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc. - To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc. - To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc. - To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.

NCT ID: NCT02919501 Completed - Clinical trials for Depressive Disorder, Major

Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

Start date: September 27, 2016
Phase: Phase 2
Study type: Interventional

To evaluate the early onset of efficacy of vortioxetine 17 mg intravenously (IV) and vortioxetine 10 mg/day oral dose regimen versus placebo IV and vortioxetine 10 mg/day oral dose regimen on depressive symptoms

NCT ID: NCT02913521 Completed - Clinical trials for Osteoarthritis, Knee

Bioequivalence Study With Clinical Endpoint for Diclofenac Sodium Topical Gel 1%

Start date: June 2015
Phase: Phase 3
Study type: Interventional

A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Three-Arm, Multi-Site Study to Evaluate the Therapeutic Equivalence of Diclofenac Sodium Topical Gel 1% (Hi-Tech Pharmacal Co., Inc.) With Voltaren® Gel (Diclofenac Sodium Topical Gel) 1% (Novartis) in Patients With Osteoarthritis of the Knee