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NCT ID: NCT00793637 Completed - Femur Fracture Clinical Trials

Evaluation of Handling and Possible Complications Related to the Newly Developed Angular Stable Locking System (ASLS)

ASLS-Pre
Start date: August 2008
Phase:
Study type: Observational

In many cases, the existing locking bolts and screws in intramedullary nails do not provide sufficient stability. Due to the play between screw and nail, the reduction can be lost and the instability can result in malunions, nonunions, or pseudoarthrosis. Consequently, secondary angular fracture dislocation (defined as a difference of the angle of 10° or more from the post-operative to the follow-up x-rays) can be observed in approximately 30% of patients after conventional intramedullary nailing of proximal third tibial fractures and in approximately 0-2% in patients with distal third tibial fractures. Therefore, an Angular Stable Locking System for Intramedullary Nails (ASLS) was developed to reduce the risk of secondary loss of reduction by providing axial and angular stability. ASLS provides angular stable fixation between nails and screws with resorbable sleeves used as dowels in the nail locking holes. The present study evaluates the handling of ASLS and the surgeon's compliance as well as any complications occurring during the baseline and the follow-up period in patients with proximal and distal tibial, femoral and humeral fractures treated with intramedullary nails. Furthermore, the relationship of any occurred complications to ASLS will be assessed.

NCT ID: NCT00792350 Completed - Clinical trials for Carcinoma, Hepatocellular

INSIGHT - Post Marketing Surveillance

INSIGHT
Start date: April 2008
Phase: N/A
Study type: Observational

In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.

NCT ID: NCT00790920 Completed - Stroke Clinical Trials

Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke

DIAS-3
Start date: December 2008
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.

NCT ID: NCT00790426 Completed - Urothelial Cancer Clinical Trials

Phase II Study of TKI258 in Advanced Urothelial Carcinoma

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

This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer

NCT ID: NCT00790088 Completed - Clinical trials for Diabetes Mellitus, Type 1

INTERPRET - International Report on Routine Practice of Sensor-enabled Pump Therapy

Start date: February 2009
Phase:
Study type: Observational

The aim of the project is to document the international routine practice in sensor usage in patients treated with sensor-augmented pump therapy and to assess which variables (e.g. training of patients, frequency of sensor usage etc) are associated with an improvement in clinical outcome(s) from the start of the sensor use to the end of the follow-up period.

NCT ID: NCT00790036 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy

PILLAR2
Start date: July 2009
Phase: Phase 3
Study type: Interventional

Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximab-chemotherapy

NCT ID: NCT00789854 Completed - Clinical trials for Major Depressive Disorder

Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients

RUBY
Start date: November 2008
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of Quetiapine extended release (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine versus Quetiapine extended release monotherapy in subjects with treatment resistant depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. As an independent objective, the primary objective will also be evaluated in two subgroups of patients: (1) patients who were resistant to two previous antidepressant therapies and (2) in the subgroup of patients with one previous failure.

NCT ID: NCT00789477 Completed - Clinical trials for Diabetic Macular Edema

DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact

DA VINCI
Start date: December 2008
Phase: Phase 2
Study type: Interventional

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

NCT ID: NCT00786903 Completed - Clinical trials for Invasive Candidiasis

Candida Spp. in the Lower Respiratory Tract: Harmless Residents or Pathogen?

Start date: November 2008
Phase: N/A
Study type: Observational

In critically ill patients Candida spp. are frequently isolated from respiratory tract secretions such as endotracheal aspirates and bronchoalveolar lavages (BAL) and are most often considered as colonizers of the respiratory tract. In contrast, pneumonia due to infection with Candida spp. is rare and is diagnosed by histological demonstration of the yeast in lung tissue with associated inflammation. In spite of this, preemptive antifungal therapy based on isolation of Candida spp. from the respiratory tract is often initiated in critically ill patients. The disadvantages of this approach include increased selective pressure for the development of antimicrobial resistance, potential risks of adverse drug reactions and high treatment costs. On the other hand, immediate administration of appropriate antifungal therapy has been shown to be an important predictor of favorable outcome for patients with invasive fungal infections. Therefore, the development of reliable diagnostic measures for the detection of invasive pulmonary candidiasis is crucial. The overall objective of the proposed research project is to identify diagnostic strategies to differentiate between Candida colonization and Candida infection of the lower respiratory tract in critically ill patients. The proposed projects intends to test the hypothesis that 1.) invasive Candida strains from the lower respiratory tract differ from colonizing Candida strains with regard to production and expression of putative virulence factors and/or that 2.) patients suffering from pulmonary invasive candidiasis differ from patients colonized by Candida spp. with regard to inflammatory markers, other serum markers (fungal antigen) and composition of indigenous pulmonary bacterial flora.

NCT ID: NCT00786422 Completed - Clinical trials for Deep Vein Thrombosis

Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer

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

This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire 3-month study duration.