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NCT ID: NCT02011282 Completed - Neuropathy Clinical Trials

Electro-Neuro-Muscular Stimulation in ICU

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

We will examine whether the application of electro-neuro-muscular stimulation (ENMS) in critical care patients, can decrease the impact or severity of the critical illness myopathy (CIM) or neuropathy. We will also assess whether electro-neuro-muscular stimulation affect the incidence density rate of nosocomial pneumonia in the ICU. Patients will be divided into two groups, Group A and Group B chosen at random. In Group A conventional physiotherapy will be applied while in Group B, ENMS will also be applied additional to physiotherapy, in the quadriceps muscles. The total time of applying ENMS will be 1 hour, it will be applied before the start of the physiotherapy per day of hospitalization and for 10 days in each patient. The definition of CIM will be based on pathology muscular biopsy (quadriceps). Patients will undergo biopsy on the 1st and 11th day after entering the study. The technique of Gomori Trichrome will be used to determine the existence or absence of myopathy. In addition the ATPase technique will be applied at different prices of PH (PH: 9,4, PH: 4,6 and PH : 4.3), thus achieving a separation of myopathy and neuropathy. The primary outcome of the study will be the incidence of myopathy in both groups, at day 12th. Considering that the incidence of myopathy in critically ill patients is 80% reducing this rate by 50% in the intervention group using statistical power equal to 0.80 up to a level of p <0.05, 12 number of patients will be required in each group.

NCT ID: NCT02008916 Completed - Clinical trials for Spondylitis, Ankylosing

16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

MEASURE 3
Start date: January 14, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

NCT ID: NCT02008227 Completed - Clinical trials for Non-Squamous Non-Small Cell Lung Cancer

A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy

OAK
Start date: March 11, 2014
Phase: Phase 3
Study type: Interventional

This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death−ligand 1 [anti-PD-L1] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

NCT ID: NCT02007473 Completed - Clinical trials for Adverse Effects in the Therapeutic Use of Plasma Substitutes

A Prospective Non-interventional Study to Evaluate the Safety of Methylene Blue Plasma

Start date: July 2013
Phase: N/A
Study type: Observational

The objective of this non-interventional study is to gather data on adverse reactions occurring with Methylene Blue plasma administered in a routine clinical practice environment; to know more about their characteristics and behaviour and the possible factors that may influence their presentation and evolution.

NCT ID: NCT02006862 Completed - Schizophrenia Clinical Trials

eVAluatIon of OLanzapine TreatmEnT

VIOLET
Start date: January 2014
Phase: N/A
Study type: Observational

This clinical observational study aims to investigate the efficacy of olanzapine (Villamos ®) in accordance with the instructions attached thereto in standard clinical practice, followed by the physician to the patient. This is a multicenter, non- interventional observational study , 6-month period without preparing the patient to take the usual his medication . A total of 3 scheduled visits : Visit 1 to Day 0 ( integration , base ) , Visit 2 at month 3 and Visit 3 at month 6 ( = end of treatment) . The purpose of the study is to demonstrate the efficacy and safety of olanzapine in patients who are indicated . Will be monitored and recorded all the different concomitant therapy . The treatment of each patient is an individual designated by the physician , according to standard clinical practice and without any intervention research purpose . During the six months of observation patients visit the clinic at the beginning (day 0 ), intermediate ( 3 months ) and end (month 6). The purpose of these visits is regularly monitored by their doctor for senile dementia and their behavior .

NCT ID: NCT02006732 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)

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

The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.

NCT ID: NCT02004873 Completed - Clinical trials for Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines

Micra Transcatheter Pacing Study

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

The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

NCT ID: NCT02000544 Completed - Clinical trials for Coronary Artery Disease

Clinical Evaluation of a Modular Extracorporeal Circulation Circuit

MiECC MODULAR
Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this clinical research study is the design of a novel modular hybrid system extracorporeal circulation circuit for open heart procedures that could easily be converted from a closed to a semi-closed circuit according to the indication. This could expand the potential of minimal extracorporeal circulation and could ultimately become the new standard circuit in performing every type of cardiac surgery.

NCT ID: NCT01999673 Completed - Clinical trials for Non-Small Cell Lung Cancer

Phase 3 Study of Bavituximab Plus Docetaxel Versus Docetaxel Alone in Patients With Late-stage Non-squamous Non-small-cell Lung Cancer

SUNRISE
Start date: December 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug docetaxel, will improve the results of the treatment for non-small-cell lung cancer.

NCT ID: NCT01998698 Completed - Cataract Clinical Trials

Monovision vs Multifocal Lens Insertion in Cataract Patients

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

The investigators would like to assess whether monovision correction of multifocal lens insertion provides more satisfaction to cataract patients following an uncomplicated phacoemulsification surgery.