Clinical Trials Logo

Filter by:
NCT ID: NCT01735175 Completed - Clinical trials for Neutropenic Complications

Phase III Study Comparing the Efficacy and Safety of LA-EP2006 and Neulasta®

PROTECT-1
Start date: June 2012
Phase: Phase 3
Study type: Interventional

The study will assess the efficacy of LA-EP2006 compared to Peg-Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

NCT ID: NCT01734967 Completed - Clinical trials for Pancreatic Neoplasms

Needle-based Confocal Endomicroscopy Examination of Pancreatic Masse

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

Introduction: Pancreatic cancer is one of the most aggressive malignancies with only 5% of patients being alive at five years. EUS (endoscopic ultra sound) is an established, sensitive diagnostic tool in pancreatic cancer and for staging purposes. Additionally, EUS enables guided fine needle aspiration (FNA), which is currently recommended as the first-line procedure whenever a pathological diagnosis is required. However, EUS-FNA as a sampling method has its drawbacks, due to a relatively low negative predictive value. Confocal laser endomicroscopy has emerged in recent years as a novel method that enables in vivo microscopic analysis during ongoing endoscopy. Recently, confocal laser endomicroscopy has gone beyond the superficial luminal indications with the development of a new microprobe, i.e. a flexible laser probe (nCLE) that can pass through a 19-gauge needle. Combined with EUS, descriptive criteria for the diagnosis of pancreatic cystic neoplasm has been developed in a multicentre trial. However, only a limited number of cases of solid pancreatic masses have been described with nCLE. Aim and Method: To describe confocal imaging criteria for pancreatic masses, lymph nodes or liver metastases identified during EUS procedures performed for pancreatic cancer staging (EUS-nCLE), while evaluating also the feasibility and safety of nCLE examination. The hypothesis is that EUS-nCLE could allow targeted tissue sampling of pancreatic lesions resulting in more accurate diagnosis. XX patients were included all presenting with a clinical suspicion of pancreatic cancer or imaging studies showing a pancreatic mass. During the procedure an nCLE preloaded 19G FNA needle was advanced into the lesion under EUS guidance. A contrast agent was administered intravenously (2.5 ml fluorescein 10%). The data was stored digitally for post procedural analysis. Afterwards EUS-FNA was performed for cytology smears to enable a final pathological diagnosis. Correlations between the nCLE images and the conventional pathology were identified.

NCT ID: NCT01732913 Terminated - Clinical trials for Indolent Non-Hodgkin's Lymphomas

Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

Yosemite
Start date: January 16, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the effect of the addition of idelalisib to rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL). An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).

NCT ID: NCT01732822 Completed - Clinical trials for Peripheral Artery Disease

A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease

EUCLID
Start date: December 4, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease.

NCT ID: NCT01732796 Completed - Clinical trials for Hepatitis C, Chronic

IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1

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

The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

NCT ID: NCT01730534 Completed - Clinical trials for Diabetes Mellitus, Non-Insulin-Dependent

Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events

DECLARE-TIMI58
Start date: April 25, 2013
Phase: Phase 3
Study type: Interventional

This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

NCT ID: NCT01727700 Completed - Tourette's Disorder Clinical Trials

Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder

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

The goal of the current trial is to determine efficacy and safety of Once-daily aripiprazole in reducing Total Tic Severity in children and adolescents with Tourette's Disorder.

NCT ID: NCT01724294 Terminated - Clinical trials for Diffuse Large B-Cell Lymphoma

An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma

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

This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year of follow-up.

NCT ID: NCT01724021 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma

A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a

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

This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.