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NCT ID: NCT01652482 Completed - Colorectal Cancer Clinical Trials

Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)

Start date: October 2012
Phase: Phase 2
Study type: Interventional

This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil [5-FU], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

NCT ID: NCT01652469 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Testing of Drugs Erlotinib and Docetaxel in Lung Cancer Patients Classified Regarding Their Outlook Using VeriStrat®.

EMPHASIS
Start date: August 2012
Phase: Phase 3
Study type: Interventional

Using a laboratory test (VeriStrat), patients with relapsed squamous cell lung cancer are assigned to two strata, VSG (VeriStrat Good) and VSP (VeriStrat Poor). They are then randomized between an EGFR-TK inhibitor (erlotinib) and chemotherapy (Docetaxel). It is hypothesized that the VeriStrat test results are able to predict the benefit of treatment with erlotinib vs docetaxel. This would suggest a significant improvement in progression-free survival for VSG patients when treated with Erlotinib, and no significant improvement in VSP patients who receive the same treatment.

NCT ID: NCT01652248 Completed - Clinical trials for Left Ventricular Function Systolic Dysfunction

Pacemaker Upgrade to Cardiac Resynchronisation Therapy in Patients With Left Ventricular Dysfunction Dependant Upon Right Ventricular Pacing

PRE-Empt
Start date: April 2008
Phase: N/A
Study type: Interventional

Patients with pacemakers often have undiagnosed heart muscle weakness. When a pacemaker battery has run down, it is easily replaced by a short procedure. In those with heart muscle weakness, who use their pacemaker most of the time (rather than acting just as a back-up) the investigators want to find out if adding a further lead to their pacemaker system improves their heart's function, kidney function and exercise capacity.

NCT ID: NCT01651780 Completed - Clinical trials for Aortic Valve Insufficiency

Open-label, Randomized Trial in Patients Undergoing TAVR to Determine Safety & Efficacy of Bivalirudin vs UFH

BRAVO-2/3
Start date: October 2012
Phase: Phase 3
Study type: Interventional

This is an international, multicenter, open-label, randomized controlled trial. All patients undergoing transfemoral TAVR at the participating centers will be eligible. All sites will initiate enrolment with 2 feasibility roll-in bivalirudin treated patients and thereafter patients will be randomly assigned to either standard dosing of bivalirudin or UFH as control. The 2 roll-in cases per site will constitute the feasibility cohort that will be followed and analyzed separately. Patients will undergo TAVR according to current standard of care practices at the treating centers. Use of antiplatelet agents pre, during, and post procedure, and possibly oral anticoagulants post procedure, will be according to the sites' standard practice. ALL available data will be collected in the eCRF prospectively

NCT ID: NCT01651637 Completed - Clinical trials for Respiratory Distress Syndrome in Premature Infants

First In Human Study on Synthetic Surfactant CHF 5633 in Respiratory Distress Syndrome

Start date: October 2012
Phase: Phase 1
Study type: Interventional

The aim of this study is to investigate the safety and tolerability of intratracheal administration of two different single doses of CHF 5633 in preterm neonates with RDS in terms of adverse events, adverse drug reactions, hematology and biochemistry values, the incidence of major neonatal morbidities including bronchopulmonary dysplasia (BPD) and mortality.

NCT ID: NCT01651598 Completed - Healthy Clinical Trials

Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients

Start date: July 2012
Phase: Phase 1
Study type: Interventional

In this trial the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of multiple dose administration of BI 144807 will be investigated in otherwise healthy, controlled asthmatic patients

NCT ID: NCT01651143 Completed - Systemic Sclerosis Clinical Trials

Proof of Biological Activity of SAR100842 in Systemic Sclerosis

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

Primary Objective: - To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis. Secondary Objectives: - To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and Lysophosphatidic acid (LPA) receptor signaling markers in blood and skin - To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the Modified Rodnan Skin score (mRSS) - To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ).

NCT ID: NCT01650480 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

HELPing Older People With Very Severe Chronic Obstructive Pulmonary Disease Towards the End of Their Lives: Developing, Piloting and Refining a Practical Intervention (HELP-COPD)

HELP-COPD
Start date: January 2012
Phase: Phase 0
Study type: Interventional

The purpose of this study is to develop, refine and pilot a novel complex (HELP-COPD) assessment, undertaken during or immediately after a hospital admission, which addresses the holistic care needs of people with severe chronic obstructive pulmonary disease (COPD).

NCT ID: NCT01650428 Completed - Rectal Cancer Clinical Trials

Bevacizumab And Combination Chemotherapy in Rectal Cancer Until Surgery

BACCHUS
Start date: April 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, toxicity and feasibility of FOLFOX/ bevacizumab and FOLFOXIRI/ bevacizumab neoadjuvant therapy in poor prognosis rectal cancer as defined by MRI.

NCT ID: NCT01649869 Completed - Clinical trials for Cytomegalovirus Infection

Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss

Start date: February 24, 2015
Phase: Phase 2
Study type: Interventional

This is an international, multi-center, double-blind, placebo-controlled evaluation valganciclovir treatment for up to 54 children (up to 4 years of age) with virologically-confirmed congenital CMV infection and hearing loss. Subject participation will be over a six-month period and study subjects will be stratified according to age. The primary objective is to assess whether a six-week course of oral valganciclovir can stabilize the hearing of children with congenital CMV infection who present with hearing loss.