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NCT ID: NCT02257385 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Comparative Study of Umeclidinium/Vilanterol (UMEC/VI) in a Fixed Dose Combination With Indacaterol Plus Tiotropium

Start date: October 15, 2014
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram [mcg] Once daily [QD]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH & Co. KG. BREEZHALER is a registered trademark of Novartis AG.

NCT ID: NCT02257060 Completed - Clinical trials for Cavotricuspid Isthmus Dependent Right Atrial Flutter

LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter

Start date: September 2014
Phase: Phase 1
Study type: Interventional

The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.

NCT ID: NCT02255656 Completed - Clinical trials for Relapsing Remitting Multiple Sclerosis

Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409

TOPAZ
Start date: January 7, 2015
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate long-term safety of alemtuzumab. Secondary Objectives: - To evaluate long term efficacy of alemtuzumab. - To evaluate the safety profile of participants who received other Disease Modifying Treatment (DMT) following alemtuzumab treatment. - To evaluate participant-reported Quality of Life (QoL) outcomes and health resource utilization of participant who received alemtuzumab. - To evaluate as needed re-treatment with alemtuzumab and other DMTs.

NCT ID: NCT02255266 Completed - Clinical trials for Diabetes Mellitus, Type 2

Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice

Start date: March 26, 2015
Phase:
Study type: Observational

This study is conducted in Europe. The aim of this study is to investigate Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.

NCT ID: NCT02254967 Completed - Clinical trials for Clostridium Difficile

A Phase IIIB/IV Study to Compare the Efficacy of Vancomycin Therapy to Extended Duration of Fidaxomicin Therapy in the Clinical Cure of Clostridium Difficile Infection (CDI) in an Older Population

EXTEND
Start date: November 6, 2014
Phase: Phase 4
Study type: Interventional

The main objective of the study is to evaluate whether the extended duration fidaxomicin therapy is superior to the standard vancomycin therapy in sustained clinical cure of CDI at 30 days after end of treatment (Day 40 or Day 55).

NCT ID: NCT02254876 Completed - Hemiplegia Clinical Trials

Effectiveness of NeuroMuscular Taping on Painful Hemiplegic Shoulder

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

Painful Shoulder Syndrome is a frequent complication after stroke occurring in between 5% and 84% of patients, often having a strong impact on their well-being and resulting in delays achieving rehabilitative objectives. The aim of the study is to demonstrate the effectiveness of Neuromuscular Taping in a population of post-stroke hemiplegic patients suffering from painful shoulder syndrome with respect to pain, spasticity and range of motion.

NCT ID: NCT02254850 Completed - Metabolic Syndrome Clinical Trials

Mesoglycan, Vascular Reactivity and Metabolic Syndrome

Start date: May 2013
Phase: Phase 4
Study type: Interventional

The purpose of the study was to characterize the action of mesoglycan on vascular endothelium through the non-invasive assessment of vascular reactivity humeral artery by comparing effects of mesoglycan on Flow Mediated Dilatation (FMD) of the humeral artery between a group of patients with metabolic syndrome assuming placebo and a group of patient with metabolic syndrome assuming mesoglycan; firstly after administration of the drug/placebo intramuscularly, and then, in a study of medium-term after oral intake of drug/placebo. The selection of patients with metabolic syndrome is related to the fact that this syndrome is associated with alterations in endothelial function and a high incidence of cardiovascular events. So it is a condition that offers the opportunity to explore the hypothesis that the mesoglycan may have a favorable effect on early vascular alterations that precede clinical events.

NCT ID: NCT02254200 Completed - Obesity Clinical Trials

Exercise Training and Fitness in Severe Obesity

INTFMOBE
Start date: January 2013
Phase: N/A
Study type: Interventional

Obesity is commonly associated with insulin resistance and hyperinsulinemia, which seem to be linked with an impaired ability to oxidize lipids, particularly in class III obese individuals [Body Mass Index (BMI): > 40 kg*m-2]. Exercise training is an effective strategy to improve insulin sensitivity and to reduce the risk of type 2 diabetes. This study aimed to compare the effects of two different 2-wk-long training modalities [continuous at the intensity eliciting the maximal fat oxidation (Fatmax) versus adapted high intensity interval training (HIIT)] on aerobic and metabolic fitness of class II and III obese men. It was hypothesized that, because of the nature of HIIT in the stimulation of rapid changes, aerobic fitness, fat oxidation rates during exercise and insulin sensitivity would be improved to a greater extent when adapted HIIT compared to Fatmax training.

NCT ID: NCT02253134 Completed - Syncope Clinical Trials

Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)

ITHO04
Start date: August 2010
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment.

NCT ID: NCT02252367 Completed - Clinical trials for Lower Urinary Tract Symptoms

Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms

Start date: December 2015
Phase: Phase 4
Study type: Interventional

At present time several preclinical and clinical study have demonstrated the safety and efficacy of PDE5 (phosphodiesterase type 5)-inhibitors for LUTS/BPH (lower urinary tract symptoms/benign prostatic hyperplasia) patients with or without erectile dysfunction. However, the link between clinical outcomes (symptoms scores), functional activity (urodynamic findings) and molecular pathways, in particular regarding inflammatory pattern (molecular analyses), has not been previously investigated. Aim of present study is to assess, for the first time in literature, changes in pressure flow study (PFS) and changes in molecular profile of prostatic tissue (inflammatory and tissue remodeling markers) in men treated for 12 weeks with tadalafil 5 mg compared with placebo and to correlate these data with changes in symptoms scores (IPSS, International Prostatic Symptoms Score) in men with LUTS secondary to BPH refractory to alpha blockers.