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NCT ID: NCT01248195 Completed - Schizophrenia Clinical Trials

Optimization of Treatment and Management of Schizophrenia in Europe

OPTIMISE
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is optimising current treatments in schizophrenia and explore novel therapeutic options for schizophrenia. The study intends to both address basic, but so far unanswered, questions in the treatment of schizophrenia and develop new interventions. It is expected that the project will lead to evidence that is directly applicable to treatment guidelines, and will identify potential mechanisms for new drug development.

NCT ID: NCT01247896 Completed - Clinical trials for Diabetes Mellitus, Type II

Single Dose Escalation Study of PF-05190457 in Healthy Volunteers

Start date: December 2010
Phase: Phase 1
Study type: Interventional

PF-05190457 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of a single dose to healthy volunteers and to evaluate the plasma drug concentrations after single dose in healthy volunteers.

NCT ID: NCT01247805 Completed - Clinical trials for Pulmonary Arterial Hypertention

A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions

Start date: January 2011
Phase: Phase 1
Study type: Interventional

The hypothesis for the trial is that the Sildenafil Citrate Powder for Oral Suspension (10 Mg/ml) bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers and the Sildenafil Citrate 10 Mg immediate release (IR) tablet is bioequivalent to the Revatio 20 Mg IR tablet in Healthy Volunteers.

NCT ID: NCT01247428 Completed - Clinical trials for Coronary Artery Disease

First-In-Human Trial of the MiStent Drug-Eluting Stent (DES) in Coronary Artery Disease

DESSOLVE-I
Start date: November 2010
Phase: Phase 2
Study type: Interventional

The DESSOLVE I clinical trial is to assess the safety and performance of the sirolimus-eluting MiStent SES.

NCT ID: NCT01247324 Completed - Clinical trials for Relapsing Multiple Sclerosis

A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis

Start date: August 31, 2011
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, double-dummy, parallel-group study will evaluate the efficacy and safety of ocrelizumab in comparison with interferon beta-1a (Rebif) in participants with relapsing multiple sclerosis. Participants will be randomized to receive either ocrelizumab 600 mg or matching placebo intravenous (IV) as 300 mg infusions on Days 1 and 15 for the first dose and as a single infusion of 600 mg for all subsequent infusions every 24 weeks, with placebo injections matching interferon beta-1a SC three times per week; or interferon beta-1a 44 mcg SC injections three times per week (with placebo infusions matching ocrelizumab infusions every 24 weeks). Planned duration of double-blind treatment is 96 weeks. Participants who complete the 96-week double-blind treatment will have an option to enter a single-group, active-treatment, open-label extension period, providing they fulfill the eligibility criteria.

NCT ID: NCT01247142 Completed - Clinical trials for Invasive Pulmonary Aspergillosis

Evaluation of Exhaled Breath Condensate in the Diagnosis of Invasive Pulmonary Aspergillosis

Start date: January 2011
Phase: N/A
Study type: Observational

The purpose of this study is to evaluate the diagnostic potential of biomarkers for invasive pulmonary aspergillosis in exhaled breath condensate.

NCT ID: NCT01246830 Completed - Malocclusion Clinical Trials

The Use of 2D and 3D Imaging Modalities and Its Influence on Diagnosis and Treatment Planning in Orthodontics

Start date: January 2012
Phase: N/A
Study type: Observational

Research questions: 1. Will the panoramic images derived from cone beam CT data give better diagnostic ability than conventional panoramic radiographs? 2. Will 3D cephalometric analysis offer the orthodontists and surgeons better information for treatment planning? 3. Will the 3D cephalometric analysis give more accurate treatment plan and better treatment outcome? General hypothesis and special aims Overall aims: - To compare 2D versus 3D cephalometric analysis: treatment planning and therapeutic outcome. - To determine the accuracy and diagnostic ability and usability of the 3D cephalometric analysis. - To evaluate the diagnostic ability and usability of the panoramic image derived from cone beam CT data as compared to 2D panoramic images. - To evaluate the value of the cone beam CT data in cephalometric analysing process for orthodontic and maxillofacial surgery treatment. Hypotheses: 1. The availability of the 3D cephalometric analysis influences the orthodontic and maxillofacial treatment plan and decision, and might change the treatment outcome. 2. Panoramic images derived from cone beam CT data may provide equal information for diagnosis as conventional panoramic images. 3. Cone beam CT will be able to replace "classic orthodontic imaging" being more time and dose efficient and having a beneficial effect on treatment outcome.

NCT ID: NCT01245452 Completed - Clinical trials for Rheumatoid Arthritis

Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate

TOMERA
Start date: May 2010
Phase: N/A
Study type: Interventional

To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in early RA patients treated with tocilizumab compared to Methotrexate alone. The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population and correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety profile of Tocilizumab.

NCT ID: NCT01245361 Completed - Clinical trials for Undifferentiated Arthritis

A 6-Months Infliximab Or Placebo Study In UA At High Risk Of RA:Clinical,Radiological And Synovial Benefit

UA-IFX
Start date: November 2007
Phase: N/A
Study type: Interventional

Patient with undifferentiated arthritis and the presence of anti-citruline (anti-CCP) antibodies are at high risk to develop RA. The presence of anti-CCP is associated with a higher rate of erosion and a higher risk of progressive and severe RA. The investigators have demonstrated in the CIERA study that MTX/IFX combination therapy is superior to MTX alone to reduce MRI signs of synovitis and bone edema and is clinically more effective. The immunopathogenesis of undifferentiated arthritis is poorly understood. However, synovial studies from patients with early arthritis suggest that UA and RA may share common immunopathogenic mechanisms. One biopsy study of asymptomatic joints in patients with early arthritis demonstrates synovitis in more than half of the joints samples with prominent T cell and macrophage infiltration, similar to Rheumatoid Arthritis (RA). Thus intensive treatment with anti-TNF antibodies (infliximab) may have an impact on multiple immune mechanisms driving synovitis in undifferentiated arthritis and may influence the clinical outcome. Recently, Methotrexate has been demonstrated to improve the course of undifferentiated arthritis and prevent the development of RA. Short regimen of more intensive therapy with Infliximab could alter the radiological, immunopathological and clinical outcome.

NCT ID: NCT01245127 Completed - Schnitzler Syndrome Clinical Trials

Ilaris (Canakinumab) in the Schnitzler Syndrome

Start date: May 2011
Phase: Phase 2
Study type: Interventional

Schnitzler syndrome: Schnitzler syndrome is a rare disabling autoinflammatory syndrome characterized by a chronic urticarial rash and monoclonal gammopathy, accompanied by intermittent fever, arthralgia or arthritis or bone pain. Diagnostic criteria have been established. The disease never remits spontaneously. Although there is no standard of care, there have been promising developments in therapeutic options, especially anti-interleukin-1 therapy. Anakinra, a synthetic analogue of the endogenous interleukin-1 receptor antagonist, has caused rapid clinical remission in 24 patients with Schnitzler syndrome. However, to sustain remission, continuous daily administration (100 mg sc) is required. The level of monoclonal protein does not decrease. Side effects of anakinra include painful injection site reactions and neutropenia. Interleukin-1 and the autoinflammatory diseases: As a key proinflammatory cytokine mediating local and systemic responses to infection and tissue injury, interleukin-1 can induce a range of responses, including fever, pain sensitization, bone and cartilage destruction, and the acute-phase inflammatory response. The so-called autoinflammatory diseases are mediated entirely by interleukin-1; reducing interleukin-1 activity brings about a rapid and sustained remission. Autoinflammatory diseases include relatively uncommon disorders such as familial Mediterranean fever, adult and juvenile Still's disease, the hyper-IG D syndrome, Behçet's syndrome, the cryoporin-associated periodic syndrome (CAPS), deficiency of the interleukin-1 receptor antagonist (DIRA) and Schnitzler's syndrome. Some common conditions such as gout and type 2 diabetes, are also likely to be autoinflammatory diseases. Canakinumab: Canakinumab (Ilaris, Novartis Pharma) is a fully human anti-interleukin-1-bèta monoclonal antibody. Treatment with subcutaneous canakinumab (150 mg) once every 8 weeks was associated with a rapid remission of symptoms in the great majority of children and adults with CAPS. Serum inflammatory markers quickly returned to normal. In general, the side effects seen in this small study (35 patients) were not serious, though suspected infections ware significantly more prevalent in patients receiving canakinumab than in those receiving placebo. The prolonged duration of action of canakinumab and low incidence of injection-site reactions may confer certain advantages over other interleukin-1 inhibitors (anakinra and rilonacept), since both are frequently associated with injection-site reactions, and both require more frequent administration (daily for anakinra and weekly for rilonacept). Canakinumab was approved for the treatment of CAPS by the US Food and Drug Administration in June 2009 and by the European Medicines Agency in October 2009. Canakinumab is currently being evaluated for its potential in the treatment of systemic-onset juvenile idiopathic arthritis, diabetes mellitus, and difficult-to-treat gouty arthritis.