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NCT ID: NCT01785888 Completed - Clinical trials for EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.

Europe-Japan Diagnostic Study for EGFR Testing

ASSESS
Start date: April 2013
Phase: N/A
Study type: Observational

This is a non-interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and Europe and will assess the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA. The data generated will inform the use of less-invasive sample types in diagnostic practice. The study also aims to assess the current status of EGFR mutation testing across Japan and Europe and gaps in currently available data including EGFR mutation frequency in particular populations and demographic subgroups, EGFR mutation frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology, utility of multiple sample types in the assessment of EGFR mutation status, and impact of EGFR mutation status on therapy choice. The data may be used to drive improvements to the EGFR mutation testing process, ensuring that patients have access to testing and are treated appropriately on the basis of the molecular features of their disease.

NCT ID: NCT01785875 Completed - Clinical trials for Hyperparathyroidism, Secondary

Extension Study of Etelcalcetide in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease (CKD) on Hemodialysis

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to describe the long-term safety and efficacy of etelcalcetide (AMG 416) for the treatment of SHPT in adults with CKD on hemodialysis.

NCT ID: NCT01785849 Completed - Clinical trials for Hyperparathyroidism, Secondary

Efficacy and Safety of Etelcalcetide (AMG 416) in the Treatment of Secondary Hyperparathyroidism (SHPT) in Patients With Chronic Kidney Disease on Hemodialysis

Start date: March 12, 2013
Phase: Phase 3
Study type: Interventional

This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

NCT ID: NCT01785095 Completed - Clinical trials for Infertility; Oocytes Donation; Immunogenicity.

Immunogenicity of Repeated Follicle Stimulating Hormone (FSH) Stimulation Cycles

Start date: March 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.

NCT ID: NCT01785043 Completed - Clinical trials for DIABETES Mellitus Type 2 Not Well Controlled

Differences in Endothelial Function Amongst Sitagliptin and Liraglutide Users

LAED001
Start date: March 2013
Phase: Phase 4
Study type: Interventional

Differences in endothelial function amongst Sitagliptin and Liraglutide Users. A randomized, open-label, parallel-group and active controlled trial

NCT ID: NCT01783678 Completed - Chronic Hepatitis C Clinical Trials

A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults

Start date: January 2013
Phase: Phase 3
Study type: Interventional

This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.

NCT ID: NCT01783613 Completed - Cystic Fibrosis Clinical Trials

Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis

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

Cystic Fibrosis (CF) is a congenital disease secondary to the abnormal function of CFTR. Patients with CF have an alteration of essential fatty acids, Arachidonic Acid (AA) is increased and Docosahexanoic Acid (DHA) is decrease and the ratio ω-6/ ω-3 is elevated, all these alterations stimulated a chronic and bad regulated state of inflammation. For this porpoise, a fase IV trial, multicentric, controlled, double blind, placebo and parallel in patients elder than two months old and randomized to received every day a dietetically supplement with DHA or placebo, will be done during 12 months. The trial has as a principal objective to proved if this long term supplementation could decrease in contrast with placebo.

NCT ID: NCT01783457 Completed - Psychosis Clinical Trials

e-Learning & Development of an Evidence-based Psychoeducational Programme for First Episode Psychosis

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

Treatment delay in psychosis usually lead to slower recovery, an increase in associated comorbidity and greater deterioration in social and family life of patients. Previous studies indicate that an early intervention with guidelines for increasing adherence to treatment, disease awareness and condition management leads to better progression of the disorder and is therefore related to a better prognosis. Several studies have found that the rate of relapse is higher in patients with pharmacological treatment alone compared to those also receiving psychoeducation, who tend to improve their adherence to treatment and reduce toxic drugs dosage. Hypotheses: - Individual psychoeducation will be effective as complementary therapy to pharmacological treatment in patients with a first psychotic episode, improving disease evolution. - BDNF levels will increase more in the patients receiving individual therapy compared to those without it. - Psychoeducation can be performed similarly in all participating centers if the therapists receive the same training and use the same psychoeducation material. - The use of telemedicine for the follow-up of the patients will help improve the welfare work and therefore the disease evolution.

NCT ID: NCT01783444 Completed - Breast Cancer Clinical Trials

A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.

BOLERO-6
Start date: February 26, 2013
Phase: Phase 2
Study type: Interventional

This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice daily for 14 days, 3-week cycle) in patients with estrogen-receptor positive, HER2 negative, advanced breast cancer after recurrence or progression on letrozole or anastrozole.

NCT ID: NCT01782911 Completed - Clinical trials for Inflammatory Markers

Effect of Resveratrol on Metabolic Parameters and Oocyte Quality in PCOS Patients

RES-IVF
Start date: February 1, 2013
Phase: N/A
Study type: Interventional

Polycystic ovary syndrome (PCOS) is characterized by enlarged ovaries, menstrual irregularity and hyperandrogenism and is the most common cause of oligoovulatory infertility. Insulin resistance with resulting hyperinsulinemia is also common among women with PCOS, along with increased risk for dyslipidemia, hypertension, diabetes and related cardiovascular consequences. Resveratrol is a natural polyphenol with anti-carcinogenic, anti-proliferative and pro-apoptotic properties, that has been shown to decrease proliferation and steroidogenesis in theca cells, emerging as a potential therapeutic agent in PCOS patients. However, little is known about its potential beneficial effect on oocyte quality as well as other reproductive outcomes, such as implantation an pregnancy rates. The present study evaluates effects of resveratrol on selected biochemical parameters and reproductive outcome among patients with PCOS who undergo in vitro fertilization (IVF).