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NCT ID: NCT01298492 Completed - Crohn's Disease Clinical Trials

A Study To Monitor Long-Term Treatment With PF-00547659

OPERA II
Start date: July 1, 2011
Phase: Phase 2
Study type: Interventional

This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.

NCT ID: NCT01298193 Completed - Breast Cancer Clinical Trials

Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.

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

This is a prospective, multicenter, open label, non-comparative trial in Spain. The primary objective of this study is to determine the complete response, defined as no vomiting and no use of rescue treatment, in women with early-stage breast cancer treated with one cycle of Docetaxel-Cyclophosphamide and active therapy for the prevention of CINV (Chemotherapy-induced nausea and vomiting) day 1, 5-hydroxytryptamine 3 (5-HT3) antagonist plus 3 days of dexamethasone. A second step (efficacy phase) is designed to examine the efficacy and tolerability of aprepitant in the second cycle among patients who failed to the previous CINV prevention treatment. The study will focus on early-stage chemonaive breast cancer patients receiving docetaxel-cyclophosphamide and a 5-HT3 antagonist plus dexamethasone for the CINV prevention. The CINV incidence in those patients will be evaluated on the first cycle. All refractory patients, will be asked to participate in the second phase, where aprepitant on days 1, 2 and 3 will be added to their antiemetic regimen. Assuming a drop out of 5%, 212 patients will be included in the study. It is anticipated that around 48 patients will enter the efficacy phase. The duration of the study, from first patient visit to last patient visit will be approximately 21 months.

NCT ID: NCT01297777 Completed - Clinical trials for Systemic Mastocytosis

Imatinib in KIT-negative Systemic Mastocytosis

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

The aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of Imatinib Mesylate therapy in patients with systemic mastocytosis lacking KIT mutations.

NCT ID: NCT01297699 Completed - Thyroid Eye Disease Clinical Trials

Tocilizumab Treatment in Graves´ Ophthalmopathy (Graves´ Orbitopathy or Thyroid Eye Disease)

GRC
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose is to investigate tocilizumab administration in patients with moderately to severely or sight-threatening GO (Graves' ophthalmopathy) without response to treatment with corticoid intravenous pulses. Currently, these patients only have surgery as therapeutic alternative. The principal aim of this study is to evaluate efficacy and safety of tocilizumab treatment in order to provide a better alternative to surgery for this patients.

NCT ID: NCT01297491 Completed - Clinical trials for Non-small Cell Lung Cancer

Safety and Efficacy of BKM120 in Patients With Metastatic Non-small Cell Lung Cancer

BASALT-1
Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of this two-stage phase II study is to assess the efficacy of BKM120, as measured by determining the progression free survival (PFS), in patients with pretreated metastatic Non-small Cell Lung Cancer (NSCLC) that exhibits PI3K pathway activation. BKM120 will be investigated in two groups of NSCLC patients according to the histology of the cancer: squamous and non-squamous.

NCT ID: NCT01296555 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Start date: March 16, 2011
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally and at escalating doses in participants with locally advanced or metastatic solid tumors. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.

NCT ID: NCT01296256 Completed - Clinical trials for Autologous Stem Cell Transplant

Bendamustine, Cytarabine, Etoposide and Melphalan (BeEAM) as Conditioning for Autologous Stem Cell Transplant (ASCT) in Aggressive Non Hodgkin's Lymphoma (NHL).

BeEAM2010-01
Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Bendamustine in combination with Etoposide, Cytarabine and Melphalan (BeEAM) are effective as conditioning followed by ASCT in patients with aggressive lymphoma.

NCT ID: NCT01295840 Completed - Heart Failure Clinical Trials

Quartet Lead and Resynchronization Therapy Options

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

The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead. Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.

NCT ID: NCT01294787 Completed - COPD Clinical Trials

Effect of QVA149 on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

BRIGHT
Start date: February 2011
Phase: Phase 3
Study type: Interventional

This study assessed the effect of once-daily indacaterol and glycopyrronium bromide (QVA149) on exercise endurance in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT01294644 Completed - Clinical trials for Moderate or Severe Submental Fullness

Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat

Start date: January 2011
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).