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NCT ID: NCT01168973 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

NCT ID: NCT01168856 Terminated - Clinical trials for Hepatitis C, Chronic

An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

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

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

NCT ID: NCT01168297 Completed - Obesity Clinical Trials

Type 2 Diabetes and Obesity in Mexican Pimas: Gene-Environment Interaction

Start date: July 6, 2010
Phase:
Study type: Observational

In 1995 we conducted a cross-sectional study to identify the effects of traditional and western environments on prevalence of type 2 diabetes mellitus (T2DM) and obesity in Pima Indians in Mexico and the United States. The Mexican Pimas live in a remote mountainous region and at that time had experienced little change from their traditional lifestyle. Nothing was known about their T2DM prevalence. A similar number of non-Pima Mexicans live in the same village. In contrast to the Mexican Pimas, the U.S. Pimas live in more westernized society and have a high prevalence of diabetes. We found that although T2DM and obesity were more prevalent in Mexican Pimas than non-Pimas, both Mexican groups had a significantly lower prevalence of these disorders than U.S. Pimas. The lifestyle of the Mexican population studied included a dramatically higher level of physical activity and a diet higher in fiber and lower in calories derived from fat compared with the U.S. Pimas. Since the U.S. and Mexican Pimas share a similar gene pool we concluded that even in populations genetically prone to T2DM and obesity, their development is determined largely by environmental circumstances. Since 1995 the environmental circumstances of the Mexican Pimas and non-Pimas have changed. The electrical supply to the region has increased, cars have become more prevalent and grocery stores have appeared. The impact of these changes on T2DM and obesity has not been examined. In light of these events, we propose to: 1) compare the current prevalence of T2DM and obesity in Mexican Pimas and non-Pima Mexicans to that present in 1995 with the same measures used previously, including height, weight, waist circumference, body composition by bioelectrical impedance, oral glucose tolerance and HbA1c; 2) compare current diet, physical activity and total energy expenditure in both Mexican Pimas and. non-Pima Mexicans using the same methods as the 1995 study to the previous results and 3) document the frequencies of T2DM and obesity-associated genetic variants in Mexican Pimas compared with U.S. Pimas and non-Pima Mexicans.

NCT ID: NCT01167881 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of Empagliflozin (BI 10773) With Metformin in Patients With Type 2 Diabetes

Start date: August 2010
Phase: Phase 3
Study type: Interventional

This is a pivotal phase III study, mandatory to seek approval by regulatory authorities for BI 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.

NCT ID: NCT01165229 Completed - Herpes Zoster Clinical Trials

Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

Start date: August 2, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.

NCT ID: NCT01165177 Completed - Herpes Zoster Clinical Trials

Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

Start date: August 2, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years. Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.

NCT ID: NCT01164852 Completed - Preeclampsia Clinical Trials

Aggressive Versus Expectant Management of Severe Preeclampsia Remote From Term

MEXPRE-Latin
Start date: August 2010
Phase: N/A
Study type: Interventional

How best to manage preeclampsia remote from term is controversial because of conflicting maternal and neonatal risks. Gestational age is the most important determinant of neonatal outcome. There are two basic approaches when delivery is not clear indicated by assessment of maternal and fetal well-being. The interventionist care when the delivery is planned within 48 hours and the expectant care which refers to pregnancy prolongation during which time women and fetuses are carefully monitored for indications for delivery. The purpose of this study is to evaluate maternal and perinatal outcomes with expectant vs interventionist or aggressive management of severe preeclampsia at 28 to 33 weeks of gestation.

NCT ID: NCT01164579 Completed - Clinical trials for Rheumatoid Arthritis

Effects of Tofacitinib (CP-690,550) on Magnetic Resonance Imaging (MRI)- Assessed Joint Structure In Early Rheumatoid Arthritis (RA)

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

Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.

NCT ID: NCT01164397 Completed - Dyslipidemia Clinical Trials

Efficiency of Rosuvastatin Versus the Fixed Combination of Ezetimibe/Simvastatin in Outpatients

Start date: April 2009
Phase: N/A
Study type: Observational

The aim of this study is to evaluate the effectiveness of Rosuvastatin versus Ezetimibe/Simvastatin in dyslipidemic patients treated for at least 8 weeks.

NCT ID: NCT01163253 Terminated - Psoriasis Clinical Trials

A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

Start date: September 2010
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.