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NCT ID: NCT01856283 Completed - Clinical trials for Leukemia, Myeloid, Chronic-Phase

Nilotinib 300 mg BID in Newly Diagnosed CP-CML Patients to Verify Disappearance of CD34+/Lin-Ph+ Cells

Start date: March 2013
Phase: Phase 2
Study type: Interventional

This is a multicentre, single-arm study of nilotinib 300 mg BID in newly diagnosed patients with CP-CML. This study is designed to establish the disappearance of Ph+ stem cells (CD34+/lin-) in BM during nilotinib treatment. In addition, in this study the investigators aim to perform Gene Expression Profiling (GEP) of CML enrolled patients using Affymetrix GeneChip Instruments and Software Systems, and Affymetrix GeneChip Human Genome U133 Plus 2.0 (whole human transcriptome analysis) at diagnosis and at 3 different time points during treatment with Nilotinib (after 3, 6, 12 months).

NCT ID: NCT01855997 Completed - Clinical trials for Hepatitis B, Chronic

A Study to Collect Blood Biomarker Samples From Patients With Chronic Hepatitis B Who Received Treatment With Pegasys (Peginterferon Alfa-2a) +/- Nucleos(t)Ide Analogue

Start date: August 2013
Phase: N/A
Study type: Observational

This phase 4 study is designed for the collection of blood biomarker samples from patients who have completed chronic hepatitis B treatment with at least 25 weeks of a Pegasys (peginterferon alfa 2a) containing regimen and at least 24 weeks post-treatment follow-up. Patients may be enrolled from historical studies supported or sponsored by Roche, ongoing studies supported or sponsored by Roche or from general medical practice. The follow-up of patients who choose to participate in this study will be in accordance with the ongoing studies or with the general medical practice of the physician. Data from whole blood DNA samples collected in the GV28555 study or available from previously collected Roche Clinical Repository (RCR) samples will be used for combined analysis with data from other applicable studies. Procedures will include blood sample collection (not applicable for patients who previously have consented and donated RCR DNA samples) and medical record capture.

NCT ID: NCT01855698 Completed - Multiple Myeloma Clinical Trials

PENELOPE Observational Study: Prophylaxis and Treatment of Arterial and Venous Thromboembolism

Start date: June 2013
Phase:
Study type: Observational

The primary objective of the study is to assess efficacy and safety of different prophylactic or therapeutic antithrombotic approaches in patients with hematologic neoplasms and platelet count <50 x109/L, including unfractionated or low molecular weight heparin, fondaparinux, anti-vitamin K agents, antiplatelet agents, novel oral anticoagulants, fibrinolytic agents, with or without a policy of platelet transfusion. Cases with arterial or venous thromboembolism managed with observation or use of vena cava filters in patients with venous thromboembolism will be included too.

NCT ID: NCT01854918 Completed - Clinical trials for Hyperlipidemia and Mixed Dyslipidemia

Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia

OSLER-2
Start date: April 23, 2013
Phase: Phase 3
Study type: Interventional

This study will contribute to the evaluation of long-term safety, tolerability and efficacy of evolocumab (AMG 145) in adults with hyperlipidemia and adults with mixed dyslipidemia.

NCT ID: NCT01854606 Completed - Clinical trials for CD79 Mutant or ABC-subtype Diffuse Large B-Cell Lymphoma

Safety and Efficacy of AEB071 and EVEROLIMUS in Patients With CD79-mutant or ABC Subtype Diffuse Large B-Cell Lymphoma

COEB071X2103
Start date: December 5, 2013
Phase: Phase 1
Study type: Interventional

Study of the safety and efficacy of AEB071 and EVEROLIMUS in patients with CD79-mutant or ABC subtype Diffuse Large B-Cell Lymphoma. The trial did not progress into Phase II due to the suboptimal tolerability of the combination treatment of sotrastaurin and everolimus in the Phase Ib part of the study. There were no serious safety concerns associated with this combination.

NCT ID: NCT01854047 Completed - Asthma Clinical Trials

An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Start date: June 2013
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma Secondary Objective: To evaluate different doses and regimens of dupilumab in patients with moderate to severe uncontrolled asthma, with regard to: - Safety and tolerability - Dupilumab systemic exposure and anti-drug antibodies

NCT ID: NCT01853943 Completed - Clinical trials for Radial Artery Occlusion

Hand Grip Test and Transradial Coronary Procedures

HANGAR
Start date: July 2012
Phase: N/A
Study type: Observational

Transradial coronary procedures are gaining in popularity worldwide. A possible complication of transradial approach is the occlusion of the radial artery that in most cases is asymptomatic. However the investigators do not know if the radial artery occlusion may impact over the muscle force of the hand or fingers. To evaluate if transradial approach for percutaneous coronary procedures may affect muscle force of the hand, thumb and index finger the investigators use a standardized hand-grip manometer and a pinch gauge before the transradial procedure, the day after the procedures and after few months.

NCT ID: NCT01853826 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Start date: July 17, 2013
Phase: Phase 3
Study type: Interventional

To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI

NCT ID: NCT01853813 Completed - Clinical trials for Colorectal Cancer Stage II

First-line Irinotecan, Lederfolin and 5FU (FOLFIRI) and Bevacizumab in Patients With Advanced Colorectal Cancer

CENTRAL
Start date: May 2013
Phase: Phase 2
Study type: Interventional

Bevacizumab in combination with chemotherapy represents a standard of care for first-line treatment in patients with advanced colorectal cancer. Molecular predictive factors for bevacizumab efficacy have not yet been identified therefore selection of patients more likely to benefit from such a treatment approach is not possible. Retrospective analyses suggested that LDH serum levels may influence the clinical activity of anti-angiogenetic drugs. Primary aim of our clinical trial will be to prospectively ascertain whether bevacizumab in combination with chemotherapy has an improved clinical activity in patients with high LDH serum levels compared to patients with normal LDH serum levels

NCT ID: NCT01853787 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Nitric Oxyde Concentration in Chronic Obstructive Pulmonary Disease Patients - SANOB Study

SANOB
Start date: July 2014
Phase: Phase 4
Study type: Interventional

- Among many other causes, Bronchial obstruction in Chronic Obstructive Pulmonary Disease (COPD) is also caused by inflammation of peripheral airways walls. - Neutrophils and other inflammatory mediators like Interleukin-6 (IL6), Interleukin-8 (IL8), Interleukin-1 alpha (IL-1 alpha),Interleukin-1beta (IL-1 beta), Tumor Necrosis Factor alfa (TNF-alfa), Reactive Oxygen Species (ROS), Leukotriene B4 (LTB4), Nitric Oxyde (NO) are implicated in the inflammation. - NO is produced in response to physical and chemical stress on bronchial epithelium and plays a critical role in small airways remodelling - Exhaled NO concentration is usually used to monitor bronchial inflammation - The relationship between stretch and strain of small airways and bronchial inflammation is not well understood. - The investigators hypothesis is that cyclic opening and closure of peripheral obstructed airways through the consequent stretching and strain acting on them can provoke an inflammatory response which can be monitored by exhaled NO. - The pharmacological effects of bronchodilators may play a role on bronchial inflammation by reducing the stretching stress on bronchiolar walls thus reducing the production of NO in exhalate - Data about these physiopathological aspects is missing in literature.