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NCT ID: NCT01155453 Completed - Clinical trials for Advanced and Selected Solid Tumors

A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of BKM120 Plus GSK1120212 in Selected Advanced Solid Tumor Patients

Start date: April 2010
Phase: Phase 1
Study type: Interventional

This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and /or recommended phase II dose (RP2D) and schedule for the PI3K (Phosphatidylinositol 3-Kinase) inhibitor BKM120 given in combination with the MEK inhibitor GSK1120212 in patients with selected, advanced solid tumors. The focus will be on tumors with RAS/RAF mutations and on triple negative breast cancer. Both study drugs will be administered once daily orally on a continuous schedule, a treatment cycle is defined as 28 days. Cohorts of at least 3 and up to a maximum of 6 patients eligible for the dose-determining set will be enrolled per dose combination below the MTD. The MTD is defined as the highest drug dosage not causing in the first cycle of treatment medically unacceptable, dose-limiting toxicity (DLT) in more than 33% of the treated patients.. At least 12 patients will be required at MTD and 6 patients at RP2D level to allow the evaluation of the combination's safety and pharmacokinetics or pharmacodynamics. Upon declaration of MTD and/or RP2D, patients will be enrolled to an expansion part of the study, to further assess safety, as well as to learn more about the efficacy of the study drug combination. - Expansion Arm 1 will consist of approximately 15 patients with RAS or BRAF mutant advanced NSCLC - Expansion Arm 2 will consist of approximately 15 patients with RAS or BRAF-mutant ovarian cancer - Expansion Arm 3 will consist of approximately 15 patients with RAS or BRAF-mutant pancreatic cancer

NCT ID: NCT01155310 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy of Helium/Oxygen Compared to Air/Oxygen in Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

ECHO/ICU
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of Helium/Oxygen (He/O2) 78%/22% compared to a conventional Air/O2 mixture in reducing endotracheal intubation rate and mortality in patients with severe hypercapnic exacerbations of Chronic Obstructive Pulmonary Disease (COPD) during their index Intensive/Intermediate Care Unit (ICU) stay.

NCT ID: NCT01154140 Completed - Clinical trials for Non Squamous Lung Cancer

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung

PROFILE 1014
Start date: January 13, 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the anti-cancer effects of crizotinib when compared with standard chemotherapy in patients with ALK positive lung cancer.

NCT ID: NCT01153620 Completed - Wounds Clinical Trials

The Antiseptic Efficacy and Tolerability of Lavasept® 0.04% on Acute Traumatic Wounds

Lavasept 2
Start date: August 2010
Phase: Phase 4
Study type: Interventional

The primary objective of the study is to assess the antiseptic efficacy of Lavasept 0.04% when used as an antiseptic agent and to compare these with Ringers' solution in patients with acute traumatic wounds.

NCT ID: NCT01151514 Completed - Mortality Clinical Trials

Referral Patterns for Hospital Acquired Acute Kidney Injury and Relevance to Renal Outcomes

HA-AKI
Start date: n/a
Phase: N/A
Study type: Observational

Few studies analyzed the referral time to nephrologists and its impact on the patient outcome in a large cohort. The investigators described the incidence and determined the outcome with respect to renal function recovery, renal replacement therapy (RRT) requirement and in-hospital mortality of Hospital Acquired Acute Kidney Injury (HA-AKI) without nephrology referral (nrHA-AKI) and late referred HA-AKI patients to nephrologists (lrHA-AKI) compared with early referral patients (erHA-AKI). The patients included were admitted to the tertiary care academic center of Lausanne (Switzerland) between 2004 and 2008, in the medical and surgical services and in the intensive care unit (ICU).

NCT ID: NCT01151423 Completed - Clinical trials for Acquired Thrombotic Thrombocytopenic Purpura

Study to Assess Efficacy and Safety of Anti-von Willebrand Factor (vWF) Nanobody in Patients With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

TITAN
Start date: January 2011
Phase: Phase 2
Study type: Interventional

This study was a Phase II, single-blind, randomized, placebo-controlled trial to determine whether anti-vWF Nanobody is safe and effective as adjunctive treatment in patients with aTTP. Patients received either placebo or anti-vWF Nanobody as adjunctive therapy to plasma exchange (PE).

NCT ID: NCT01151137 Terminated - Atrial Fibrillation Clinical Trials

Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

PALLAS
Start date: July 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors Secondary Objective: - Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

NCT ID: NCT01150253 Completed - Allergic Rhinitis Clinical Trials

Effect of a Probiotic on Grass Pollen Allergic Rhinitis Subjects

Start date: August 2006
Phase: N/A
Study type: Interventional

Various studies in animals and humans have shown a potential beneficial effect of probiotics consumption on allergy. However, few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. The objective of this study is to investigate the effect of short-term oral administration of a Lactobacillus paracasei on a nasal provocation test (NPT) with grass pollen, performed out of pollen season. Adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind, placebo-controlled study, based on two 4-weeks cross-over periods of product consumption (probiotic-fermented milk versus placebo), separated by a washout period of 6-8 weeks. Objective and subjective clinical parameters of NPT as well as systemic and nasal immunological parameters are compared between the two treatment periods.

NCT ID: NCT01150240 Enrolling by invitation - Clinical trials for Primary Immunodeficiency Disease

Clinical and Laboratory Online Patient- and Research Database for Primary Immunodeficiencies in Switzerland

Start date: October 2006
Phase: N/A
Study type: Observational

A Swiss national, multi-centre, online patient and research database will be created, using the existing ESID database server system. This database contains disease-specific data from patients with primary (inborn) immunodeficiency diseases (PID).

NCT ID: NCT01149447 Recruiting - Stroke Clinical Trials

Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale

PFO-HUG
Start date: January 2001
Phase: N/A
Study type: Observational

Following a cryptogenic stroke, many patients are nowadays treated with the percutaneous closure of a patent foramen ovale (PFO), assuming that the aetiology of the stroke is secondary to a paradoxical embolism. After the PFO closure procedure a dual antiplatelet regimen is often prescribed for 3-6 months and several cardiologic and neurologic follow-up exams are scheduled in the first 12 months of follow-up. Usually a transthoracic +/- transoesophageal echocardiography (TTE +/- TEE) are performed at 6 months, however this kind of control is not systematically performed. In order to improve the clinical outcomes in this young patients' population, the investigators prospectively perform a complete cardiologic and neurologic follow-up program to all patients undergoing a successful percutaneous closure of a PFO. The aim of these controls is to confirm the good position of the PFO-device, to confirm the absence of any residual right to left shunt or any significant atrial arrhythmias Furthermore this prospective follow-up will analyze the possible mechanisms leading to a cerebral stroke recurrence (e.g. size of the PFO, presence of an atrial septal aneurysm, presence of a residual shunt, size of the utilized closure device, ....).