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NCT ID: NCT01036438 Completed - Venous Leg Ulcers Clinical Trials

Evaluating the Efficacy of an Absorbent Foam Dressing Containing Silver (Mepilex Ag) Versus the Same Dressing Without Silver Used on Subjects With Venous Leg Ulcers or Mixed Ulcers

Start date: December 2009
Phase: Phase 4
Study type: Interventional

Compare the efficacy of using an absorbent foam silver dressing (Mepilex Ag) versus the equivalent dressing without silver in subjects suffering from venous leg ulcer or mixed ulcer with an ABPI ≥ 0.8 and with inflammatory signs. Efficacy will be defined as absolute wound size reduction.

NCT ID: NCT01035255 Completed - Clinical trials for Heart Failure With Reduced Ejection Fraction

This Study Will Evaluate the Efficacy and Safety of LCZ696 Compared to Enalapril on Morbidity and Mortality of Patients With Chronic Heart Failure

PARADIGM-HF
Start date: December 2009
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV and EF =< 35%).

NCT ID: NCT01035190 Completed - Clinical trials for Bronchopulmonary Dysplasia

Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

NEuroSIS
Start date: April 2010
Phase: Phase 3
Study type: Interventional

HYPOTHESIS: Early prophylactic inhalation of Budesonide reduces the absolute risk of developing bronchopulmonary dysplasia (BPD) or death in preterm infants born <28 weeks gestational age (GA) by 10%. PRIMARY OBJECTIVE: To determine whether inhalation of Budesonide within 12 hours of life improves survival without BPD at 36 weeks GA in infants born between 23 and 27 weeks GA. SECONDARY OBJECTIVES: To determine whether prophylactic inhalation of Budesonide affects neurodevelopment at a corrected age of 18-22 months in preterm infants; to determine whether inhalation of corticosteroids is associated with adverse treatment effects, alters mortality at 36 weeks GA, BPD incidence at 36 weeks GA, and the duration of positive pressure respiratory support or supplemental oxygen. RATIONALE: Pre- and postnatal exposure of the developing lung to inflammation is central to the development of BPD and the pulmonary inflammatory response in preterms at risk of developing BPD is established very early in life. Corticosteroids have antiinflammatory properties and early inhalation of corticosteroids may allow for beneficial local effects on the pulmonary system prior to the development of a full inflammatory response with a lower risk of undesirable systemic side effects. STUDY DESIGN: Randomised placebo-controlled, multi-centre clinical trial. RESEARCH PLAN: Within 2 years 850 infants of 23-27 weeks GA will be randomised during the first 12 hours of life to Budesonide or placebo to prevent BPD. Study drugs will be administered via Aerochamber and continued until infants are either off supplementary oxygen and positive pressure support or have reached a GA of 32 0/7 weeks regardless of ventilatory status. The primary outcome of survival without BPD will be determined at 36 weeks GA and BPD will be defined according to the physiological definition. Study patients will be followed and neurodevelopmental outcomes will be assessed at a corrected age of 18-22 months. CLINICAL SIGNIFICANCE: BPD not only contributes to the mortality of preterm infants but is also associated with impaired neurosensory development in Extremely Low Birth Weight (ELBW) survivors, frequent readmission to hospital in the first 2 years of life, as well as with an increased risk of asthma, lung function abnormalities and persistent respiratory symptoms in adolescence and young adulthood. Systemic corticosteroids are effective in preventing BPD, but their use is practically prohibited given their adverse effects on neurodevelopment. Early inhalation of corticosteroids has been shown to be associated with secondary pulmonary benefits, but its effect on survival without BPD and on neurodevelopment remains unclear.

NCT ID: NCT01032317 Completed - Atrial Fibrillation Clinical Trials

Study of a New Catheter Using Force Sensing Capabilities for the Treatment of Atrial Fibrillation and Ventricular Tachycardia

EZCF-125
Start date: November 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to study the treatment of Atrial Fibrillation and ischemic Ventricular Tachycardia using a RF ablation catheter with contact force sensing capabilities.

NCT ID: NCT01032304 Unknown status - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD)

RESTORE
Start date: August 2009
Phase: Phase 3
Study type: Interventional

The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.

NCT ID: NCT01029886 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety and Efficacy of Exenatide Once Weekly Versus Liraglutide in Subjects With Type 2 Diabetes

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

No head to head comparisons between exenatide once weekly and liraglutide have been performed. Therefore, the purpose of this study is to compare exenatide once weekly to once-daily liraglutide with regard to HbA1c, body weight, subject-reported outcomes, and other clinical benefits. The study includes a 26-week treatment period and a safety follow-up visit 10 weeks after the final study drug dose.

NCT ID: NCT01029795 Terminated - Clinical trials for Diabetes Mellitus, Type 2

A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus

Start date: February 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to help answer the following research question(s): - To test if taking LY2599506 for 12 weeks controls blood sugar better than taking glyburide for 12 weeks. - To evaluate the safety of LY2599506 in participants with diabetes. - To determine if LY2599506 has the ability to control blood sugar in participants with diabetes. - To determine how much LY2599506 should be given to participants. - To determine if LY2599506 has an effect on a participant's weight. The study design consists of 4 study periods: a screening period, a 4-week dose adjustment period, an 8-week treatment period, and a 4-week follow up period.

NCT ID: NCT01026285 Completed - Schizophrenia Clinical Trials

InORS - International Observational Registry on Schizophrenia With Injectable Risperidone and Oral Antipsychotics

Start date: June 2009
Phase: Phase 4
Study type: Observational

International Observational Registry on Schizophrenia

NCT ID: NCT01023581 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes

AM7D
Start date: November 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of alogliptin combined with metformin, once daily (QD) or twice daily (BID), in participants with Type 2 Diabetes.

NCT ID: NCT01023516 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol

Start date: November 2009
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD