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NCT ID: NCT00969176 Completed - Pain Clinical Trials

Pharmacokinetics, -Dynamics and Safety of Intravenous Paracetamol in Neonates

PARANEO
Start date: September 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is triple, i.e. document single dose pharmacokinetics and -dynamics of intravenous paracetamol in preterm and term neonates after a loading dose (20 mg/kg iv bolus paracetamol), document multiple dose pharmacokinetics and -dynamics of intravenous paracetamol in preterm and term neonates, based on the daily doses routinely used within the neonatal intensive care unit and as reported in literature. Finally, document safety of single and repeated dose of intravenous paracetamol in preterm and term neonates.

NCT ID: NCT00968708 Completed - Clinical trials for Diabetes Mellitus, Type 2

Cardiovascular Outcomes Study of Alogliptin in Patients With Type 2 Diabetes and Acute Coronary Syndrome

EXAMINE
Start date: September 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the cardiovascular outcomes of alogliptin, once daily (QD), compared with placebo, in addition to standard of care, in patients with type 2 diabetes mellitus and acute coronary syndrome.

NCT ID: NCT00968539 Completed - Influenza Clinical Trials

Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults

Start date: September 8, 2009
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.

NCT ID: NCT00968526 Completed - Influenza Clinical Trials

Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults

Start date: September 8, 2009
Phase: Phase 3
Study type: Interventional

The objective of the study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A.

NCT ID: NCT00967304 Completed - Clinical trials for Idiopathic Venous Thromboembolism

Clinical Decision Rule Validation Study to Predict Low Recurrent Risk in Patients With Unprovoked Venous Thromboembolism

REVERSEII
Start date: November 2008
Phase: Phase 4
Study type: Interventional

The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.

NCT ID: NCT00967018 Completed - Prostate Cancer Clinical Trials

A Long Term Safety Study of Degarelix in Patients With Prostate Cancer

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

Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.

NCT ID: NCT00966758 Completed - Asthma Clinical Trials

Open, Prospective Pilot Study to Obtain Aerosol Distribution in Asthmatic Patients Using Single Photon Emission Computed Tomography (SPECT) for Comparison With Functional Imaging Using Computer Methods

Start date: July 2009
Phase: N/A
Study type: Interventional

In this open prospective study, 6 well controlled asthmatic patients will undergo a high-resolution multi-slice computed tomography (CT) scan, lung function tests and a SPECT scan to obtain patient specific geometries of the central and peripheral small airways, patient specific boundary conditions and the in-vivo spatial distribution of inhaled aerosols.

NCT ID: NCT00966459 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Computed Tomography (CT) and Lung Function Data Collection for Computational Fluid Dynamics (CFD) in Chronic Obstructive Pulmonary Disease (COPD) Patients

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

In this study, 20 COPD patients will undergo a high-resolution/multi slice CT scan and lung function tests to obtain patient specific geometries of the central and peripheral small airways and patient specific boundary conditions. With Computational Fluid Dynamics (CFD), the investigators will be able to reconstruct the geometry and measure the resistance of the peripheral airways. In a later stage, CFD will be used to simulate the reaction of the airways on various inhalation medications.

NCT ID: NCT00966043 Completed - Breast Neoplasms Clinical Trials

Prevalence of Genetic Polymorphisms in Genes Coding for Tamoxifen Metabolising Enzymes

CYPTAMBRUT-3
Start date: June 2009
Phase: Phase 3
Study type: Observational

CYPTAM-BRUT 3 is a prospective, multicentric study in Belgium within the CYPTAM study of the Leiden University Medical Center (NTR1509) including postmenopausal women receiving tamoxifen for estrogen-receptor positive breast cancer in the adjuvant setting. The primary endpoint is the difference in uterine changes between women with a normal versus low TAS after 3 months of tamoxifen use. Secondary endpoints are serum metabolite concentrations, serum follicle-stimulating hormone level, serum sex hormone-binding globulin level and menopausal symptoms. These patients are registered in the Leiden protocol with time to breast cancer event as primary endpoint.

NCT ID: NCT00965939 Completed - Clinical trials for ER-positive Breast Cancer

An Observational Study to Assess Response to Tamoxifen in Breast Cancer Patients

CYPTAMBRUT-2
Start date: February 2009
Phase: N/A
Study type: Observational

CYPTAM-BRUT 2 is a prospective, multicentric study including postmenopausal women receiving tamoxifen for metastatic, locally advanced (stage IIIB/C) or in the neoadjuvant setting for measurable estrogen-receptor positive breast cancers. The primary endpoint is the difference in efficacy of tamoxifen, defined as the objective response rate using RECIST criteria, between women with a normal versus low Tamoxifen Activity Score (TAS) after 3-6 months of tamoxifen use. The TAS score is based on the presence of genetic variations and drug interactions. Secondary endpoints are time to progression, clinical benefit, serum metabolite concentrations, endometrial changes and menopausal symptoms. Patients using tamoxifen in the neoadjuvant setting needs being operated between 4-6 months following the start of tamoxifen.