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NCT ID: NCT01532310 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab (BENLYSTA®) Pregnancy Registry

Start date: July 16, 2012
Phase:
Study type: Observational [Patient Registry]

This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.

NCT ID: NCT01526369 Completed - Clinical trials for Metastatic Breast Cancer

A Randomized Study of TH Versus THL in First Line Treatment of HER2-positive Metastatic Breast Cancer

TH V THL
Start date: February 13, 2012
Phase: Phase 3
Study type: Interventional

The proposed phase III randomised trial will compare the efficacy of trastuzumab and paclitaxel with trastuzumab, paclitaxel and lapatinib in first line treatment of HER2 positive metastatic breast cancer. The investigators will also examine potential predictive biomarkers of response to trastuzumab and lapatinib in pre-treatment biopsy samples and serum samples.

NCT ID: NCT01523912 Completed - Neoplasia Clinical Trials

Radiofrequency Ablation for the Treatment of Gastric Dysplasia

Start date: January 2011
Phase: Phase 4
Study type: Interventional

The finding of gastric dysplasia not associated with macroscopic lesions (DNAML) or the follow-up of dysplasia after endoscopic resection (DAER) is a challenging dilemma. In the last few years, radiofrequency ablation (RFA) has become a recognized tool in the treatment of dysplastic Barrett's esophagus, but its use in gastric dysplasia has not yet been studied. The investigators aim to study the efficacy, safety and tolerability of RFA in the treatment of dysplastic gastric mucosa.

NCT ID: NCT01523587 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

Start date: March 5, 2012
Phase: Phase 3
Study type: Interventional

This randomised, open-label phase III trial will be performed in patients with advanced squamous cell carcinoma of the lung requiring second-line treatment after receiving first-line platinum-based chemotherapy. The primary objective of this trial is to compare the efficacy of BIBW 2992 to erlotinib as second-line treatment in this group of patients.

NCT ID: NCT01521754 Completed - Refractory Epilepsy Clinical Trials

Product Surveillance Registry- Deep Brain Stimulation for Epilepsy

MORE
Start date: March 6, 2012
Phase:
Study type: Observational

The purpose of this observational registry is to evaluate the long-term effectiveness, safety and performance of market-released Medtronic Neuromodulation products for Deep Brain Stimulation (DBS) for the treatment of refractory epilepsy. In addition, healthcare resource use and patient reported outcomes, such as health related quality of life will be assessed.

NCT ID: NCT01519674 Completed - Clinical trials for Diabetes Mellitus, Type 2

Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

SIT2MIX
Start date: June 2012
Phase: Phase 4
Study type: Interventional

This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)). The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.

NCT ID: NCT01519284 Completed - Parkinson Disease Clinical Trials

Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetic

Start date: November 2009
Phase: Phase 1
Study type: Interventional

To investigate the effect of repeated dosing of BIA 9-1067 on the levodopa pharmacokinetics, in comparison to placebo and entacapone.

NCT ID: NCT01515423 Completed - Schizophrenia Clinical Trials

Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

Start date: May 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.

NCT ID: NCT01507831 Completed - Clinical trials for Hypercholesterolemia

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Start date: January 2012
Phase: Phase 3
Study type: Interventional

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: - To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. - To evaluate the effects of alirocumab on other lipid parameters.

NCT ID: NCT01502722 Completed - Thirst Clinical Trials

Effect of Ingestion of Sugary Drinks on Thirst Sensation

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

The purpose of this study is to determine if regular soft drinks (with sugar) have the same effect on thirst as diet soft drinks(with sweeteners).