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NCT ID: NCT01148329 Completed - Clinical trials for Coronary Heart Disease

PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post-Approval Surveillance Study

PE-Prove
Start date: June 2010
Phase: N/A
Study type: Observational

The goal of the PROMUS™ Element™ Everolimus-Eluting Coronary Stent System European Post- Approval Surveillance Study is to evaluate real world clinical outcomes data for the PROMUS™ Element™ Coronary Stent System in unselected patients in routine clinical practice.

NCT ID: NCT01148043 Completed - Osteoarthritis Clinical Trials

Pharmacological Treatment In Osteoarthritis

FABIO
Start date: July 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of hydroxychloroquine in hand osteoarthritis.

NCT ID: NCT01147926 Completed - Clinical trials for Male Subjects With Chronic Constipation

Evaluation of Prucalopride in Male Subjects With Chronic Constipation.

Start date: September 23, 2010
Phase: Phase 3
Study type: Interventional

This is a multi-centre, randomised, parallel-group, double-blind, placebo-controlled phase III trial to evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation. Furthermore the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride will be assessed.

NCT ID: NCT01147848 Completed - Asthma Clinical Trials

HZA113091 Efficacy and Safety of Fluticasone Furoate/Vilanterol (GW642444) in Adults and Adolescents

Start date: June 2010
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily with fluticasone propionate/salmeterol administered twice daily in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

NCT ID: NCT01147250 Completed - Clinical trials for Acute Coronary Syndrome

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

ELIXA
Start date: June 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - To demonstrate that lixisenatide can reduce cardiovascular morbidity and mortality [composite endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina] compared to placebo in type 2 diabetic patients who recently experienced an acute coronary syndrome (ACS) event. Secondary Objectives: To demonstrate that when compared to placebo, lixisenatide can reduce: - composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, or hospitalization for heart failure - composite endpoint of cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure - urinary albumin excretion (based on the urinary albumin/creatinine ratio). To assess the safety and tolerability of lixisenatide.

NCT ID: NCT01146652 Completed - Clinical trials for Rheumatoid Arthritis

Long Term Evaluation of Sarilumab in Rheumatoid Arthritis Patients (SARIL-RA-EXTEND)

Start date: June 21, 2010
Phase: Phase 3
Study type: Interventional

Main Study: Primary Objective: Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA). Secondary Objective: Assess the long term efficacy of sarilumab in participants with RA. Sub-Study: This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.

NCT ID: NCT01146301 Completed - Carotid Stenosis Clinical Trials

Platelet Inhibition and Transcranial Doppler (TCD)-Detected Microemboli During and After Carotid Artery Stenting (CAS) in Asymptomatic Patients Prior to Cardiac Surgery

IMPACT
Start date: March 2008
Phase: Phase 4
Study type: Interventional

As with coronary artery stenting, activation and embolisation of platelets occurs with carotid artery stenting (CAS). Based on promising data on the use of clopidogrel plus aspirin in coronary stenting this dual antiplatelet regimen has been introduced as adjunctive treatment during CAS. There is as yet, however, no randomized controlled trial which compared different loading doses of clopidogrel during CAS. Taking into account that a wide interindividual variability in the response to a loading of clopidogrel exists, this study is intended to establish the optimal loading dose of clopidogrel. Therefore platelet function testing and a 1-hour of postprocedural TCD (transcranial doppler) monitoring will be performed. Objective: Firstly, to investigate whether the absolute magnitude of Platelet Inhibition inversely correlates with the number of TCD-detected microemboli during and after CAS in patients who are being pre-treated with either a 300 mg or a 600 mg loading dose of clopidogrel. Secondly, if there is any impact on early neurological outcome determined by the loading dose of clopidogrel.

NCT ID: NCT01145937 Terminated - Keratoconus Clinical Trials

PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus

PENTACON
Start date: March 2011
Phase: N/A
Study type: Interventional

Rationale: Keratoconus is a progressive, non-inflammatory corneal disease in which irregular refractive properties of the cornea result in loss of visual acuity. Treatment is aimed at improving vision, principally using (rigid) contact lenses. With progression of the disease non-correctable refractive abnormalities and/or corneal scars arise. For these advanced stages of keratoconus, a corneal transplant is the only treatment modality. New surgical grafting modalities have been developed to create partial thickness grafts, according to the location of corneal pathology. For keratoconus, transplanting only the anterior corneal lamellae lowers long-term graft rejection rates. We utilize a method to enhance the safety of the grafting procedure while better visual outcomes are expected. Objective: To investigate the additional value of partial endothelial trepanation (PET) in an anterior lamellar keratoplasty (ALKP) procedure in terms of efficacy and safety in patients with keratoconus. Study design: A randomized controlled interventional trial Study population: Patients over 18 years old with keratoconus in whom contact lens correction is unsuccessful and who are not suitable for corneal crosslinking. Intervention: Patients will be randomly assigned to corneal grafting techniques; partial endothelial trepanation in addition to an anterior lamellar keratoplasty (i.e. the PET group) or a regular ALKP procedure. Study outcomes: Risk of per-operative perforation. Secondary, factors contributing to treatment safety and efficacy. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There is no extra burden or risk associated with participation in this study. All measurements are part of normal clinical practice. Adequate experience is available with both surgical techniques. Study participation has no effect on donor selection. If partial endothelial trepanation (PET) is associated with lower complication rates and better visual outcomes, this might be beneficial in terms of morbidity.

NCT ID: NCT01145300 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Biomarkers in Chronic Obstructive Pulmonary Disease (COPD)

Start date: June 2010
Phase: N/A
Study type: Observational

Chronic obstructive pulmonary disease (COPD) is one of the leading causes of morbidity and mortality worldwide and is characterized by fixed airflow obstruction. The cornerstone of the disease is chronic inflammation leading to narrowing of the small airways and thus impairment of lung function. Compared to spirometry, the single breath N2-washout-test is more sensitive to identify the regional heterogeneity of bronchial airflow obstruction in the small airways. The aim of this study is to evaluate whether there is a correlation between the sbN2-test, markers in exhaled air and the inflammatory cells in the small airways.

NCT ID: NCT01145131 Completed - Aging Clinical Trials

Dietary Interventions for Muscle Mass

Start date: May 2011
Phase: N/A
Study type: Interventional

Dietary intervention to prevent sarcopenia in elderly people. The objective of this study is to test whether meat structure plays an important role in protein digestion, to maximise the amino acid availability and to stimulate the muscle protein growth in elderly people.