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NCT ID: NCT02966379 Completed - Cochlear Implant Clinical Trials

Hearing Preservation and Electro-acoustic Stimulation With EVO® Electrode Lead and Zebra® Sound Processor

Start date: March 30, 2016
Phase: N/A
Study type: Interventional

Some candidates to cochlear implantation can have residual low frequencies hearing. The EVO electrode lead has been specifically designed to preserve this residual hearing through surgery. It is then possible to provide the patient with a electro-acoustic stimulation (EAS) which combines both an acoustical stimulation for the preserved low frequency hearing and an electrical stimulation through the cochlear implant. The major aim of this study is to evaluate hearing preservation after implantation with the EVO electrode lead. The secondary outcome is to evaluate the benefit of EAS stimulation provided by the Zebra speech processor.

NCT ID: NCT02966366 Completed - Tinnitus Clinical Trials

Tinnitus Treatment With Cochlear Implant in Single Sided Deafness

Start date: August 27, 2013
Phase: N/A
Study type: Interventional

Recent studies have reported successful reduction of tinnitus after cochlear implantation (CI) in most CI users, but the mechanisms of reduction and the amount of improvement is not fully understood. Especially, the relative role of peripheral and central auditory pathways is not clearly known. This study assessed the effect of CI electrical stimulation on tinnitus in subjects with unilateral tinnitus related to a single-sided deafness (SSD), and relative contributions of peripheral and central auditory pathways in tinnitus reduction.

NCT ID: NCT02964130 Completed - Chronic Pain Clinical Trials

Study on Failed Back Surgery Syndrome Pathway Optimization: A Focus on Patient Identification, Chronicization Factors and Outcome Predictors

PREDIBACK
Start date: January 2017
Phase: N/A
Study type: Interventional

This pilot study is part of a global project that aims to better define and understand features of FBSS/POPS "post-operative persistent syndrome patients (shortened as "FBSS" in the following project). FBSS is the acronym for Failed Back Surgery Syndrome, which has been defined as a chronic condition resulting from spinal interventions. Despite anatomically successful spine surgery, a significant proportion of patients is experiencing chronic refractory back and leg pain. In a recent multicentre study conducted on more than 100 refractory FBSS patients, (ESTIMET Study), the mean delay between pain occurrence and FBSS diagnosis was 5 years. Therefore, FBSS pattern and potential responder stratification might guide us to eventually develop a decision tool for identifying FBSS patients. Easing and helping diagnosis of FBSS should improve referral yield to specialists and accelerate patient flow through the care pathway. Hence, FBSS patients, who usually present a long standing history of pain, would have access to "appropriate" therapies earlier. This could lead to better outcomes. The aim of this multicentre, prospective study is to collect specific data that are not collected in routine in order to better define and understand the potential FBSS population and to accelerate the diagnostic and optimize the choice of appropriate treatment. A multidisciplinary approach through a pain management clinical network, as it has been structured in Poitiers, will ensure that an exhaustive characterization of FBSS patients and their care pathway will be collected. In addition, since the cooperation between orthopaedic and neuro spine surgeons is not a common relationship found all over Europe (as it is observed in Poitiers), this study also aims to better understand the development of interactions between physicians/professionals and the substantial advantage which would result from bridging this gap. The N3MT (NeuroMapping Tools) software developed in Poitiers to collect data and assess objectively pain surface and intensity changes, before/after any treatment, with quantitative measurements, will be used as the central key of this project.

NCT ID: NCT02963883 Completed - Cardiac Surgery Clinical Trials

Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery

PITT
Start date: December 2016
Phase: N/A
Study type: Interventional

Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.

NCT ID: NCT02963766 Completed - Type 2 Diabetes Clinical Trials

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

AWARD-PEDS
Start date: December 29, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.

NCT ID: NCT02963649 Completed - Clinical trials for Peripheral Arterial Disease

IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

Start date: March 2, 2017
Phase: N/A
Study type: Interventional

To assess the safety and efficacy of the paclitaxel drug-eluting balloon IN.PACT 014 versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.

NCT ID: NCT02963545 Completed - Cerebral Infarction Clinical Trials

TSK (Tryptophan - Serotonin - Kynurenine) Biomarkers Assessment in Stroke

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

Single-center, prospective, descriptive and biomedical research with controls, without health product. Depression is the second risk factor for stroke as tobacco smoking following hypertension. Peripheral abnormalities in serotonin parameters were described in depression and tobacco smoking. The investigators hypothesized dysregulations in pathways of serotonin (5-HT), which has notably complex vasomotor effects and of kynurenine which could have cognitive dysfunction effects. The aim of this study is to evaluate simultaneously the involvement of serotonin and kynurenine pathways parameters in patients suffering from a cerebral infarction shortly after the onset (less than 4 hours and a half), within a 2 days follow-up (Day 1 and Day 2) and 3 months after the cerebral infarction.

NCT ID: NCT02963493 Completed - Multiple Myeloma Clinical Trials

A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

HORIZON
Start date: December 28, 2016
Phase: Phase 2
Study type: Interventional

This study will evaluate melflufen in combination with dexamethasone in adult patients with relapsed or refractory multiple myeloma in whose disease is refractory to pomalidomide and/or an anti-CD38 monoclonal antibody. All patients in the study will be treated with melflufen on Day 1 and dexamethasone on Days 1, 8, 15 and 22 of each 28-day cycle.

NCT ID: NCT02963272 Completed - Heart Failure Clinical Trials

ST2 for the Management of Heart Failure - STADE-HF

STADE-HF
Start date: January 19, 2017
Phase: N/A
Study type: Interventional

Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). It is also a major cause of health burden representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these costs are due to hospitalization. Besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters. This study aims to assess the value of ST2 in the management of patients admitted for HF to reduce readmission at one month.

NCT ID: NCT02962895 Completed - Clinical trials for Primary Sjogren Syndrome

Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)

Start date: June 27, 2017
Phase: Phase 2
Study type: Interventional

This study will determine the dose-response relationship of VAY736 for key efficacy and safety parameters