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NCT ID: NCT01420744 Completed - Clinical trials for Community Acquired Pneumonia

Safety and Efficacy Study of BT086 to Evaluate Adjunctive Therapy in sCAP

CIGMA
Start date: August 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the adjunctive therapy to standard antibiotic treatment of BT086 is safe and effective of decreasing the days patients require endotracheal ventilation due to Severe Community-Acquired Pneumonia (sCAP).

NCT ID: NCT01420302 Completed - Critical Illness Clinical Trials

LOGIC-Insulin Algorithm-guided Versus Nurse-directed Blood Glucose Control During Critical Illness

LOGIC-1
Start date: August 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The LOGIC-Insulin computerized software algorithm will be compared with a nurse-directed protocol, both targeting a blood glucose level of 80-110 mg/dL, in critically ill patients

NCT ID: NCT01420146 Completed - Breast Neoplasms Clinical Trials

Pilot Imaging Study With 89Zr-Trastuzumab in HER2-positive Metastatic Breast Cancer Patients

IJBMNZrT003
Start date: August 2011
Phase: Phase 1
Study type: Interventional

Evaluation of the diagnostic potential of HER2 imaging using zirconium 89 labelled trastuzumab.

NCT ID: NCT01420120 Completed - Clinical trials for Peripheral Arterial Disease

Remedy, Biodegradable Peripheral Stent Registry

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

This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.

NCT ID: NCT01419990 Completed - Healthy Clinical Trials

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects

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

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo. During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.

NCT ID: NCT01419717 Completed - Clinical trials for Bone Metastases in Subjects With Advanced Breast Cancer

Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

Start date: November 22, 2011
Phase: Phase 3
Study type: Interventional

This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.

NCT ID: NCT01419171 Completed - Clinical trials for Coronary Artery Disease

The OMEGA Clinical Trial

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

The purpose of this study is to evaluate the safety and effectiveness of the OMEGA Coronary Stent System for the treatment of subjects with a de novo atherosclerotic coronary artery lesion.

NCT ID: NCT01418846 Completed - Pediatrics Clinical Trials

Determination of Voriconazole Levels in Saliva - Validation in Specific Subsets of Patients

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

The purpose of this study is to investigate the intra-saliva penetration of voriconazole in different subpopulations. The goal is to develop, optimize and validate an easy, non-invasive and painless procedure for Therapeutic Drud Monitoring of voriconazole that can be used in children, ambulatory patients and in patients in whom blood drawing is difficult.

NCT ID: NCT01418833 Completed - Clinical trials for Patients Treated With Voriconazole

Preliminary Experience of Routine Voriconazole Therapeutic Drug Monitoring (TDM) in a Tertiary Care Centre

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

The first goal of this study is to map all the subtherapeutic, therapeutic and supratherapeutic voriconazole plasma levels in the University Hospitals Leuven. The second objective is to optimize and validate guidelines for dose modifications in patients with too low or high plasma concentrations and to investigate if the same guidelines can be used in different patient populations.

NCT ID: NCT01417936 Completed - Clinical trials for Carcinoma, Squamous Cell of Head and Neck

Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy

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

The trial is designed as a multi-center, open label Phase 2 trial that investigates the efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to that therapy. It is believed that Sym004 has the potential to induce tumor responses and provide a superior treatment option to subjects with advanced SCCHN. Symphogen was the sponsor for planning/conducting and reporting results for this trial.