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NCT ID: NCT01367145 Completed - Clinical trials for Peripheral Arterial Disease

OMEGA-3-Polyunsaturated Fatty-Acids (N3-Pufa) In Patients With Peripheral Arterial Disease

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

The principal aim of the study is to determine the effects n3-PUFA on top of standard therapy on surrogate markers of disease severity and/or prognosis in patients with PAD. Treatment duration will be 3 months, final follow-up is planned at 6 months after inclusion. Primary outcome parameter is endothelial function assessed by flow-mediated vasodilation using brachial artery ultrasound. Secondary outcome measures comprise maximum and pain-free treadmill walking distance, pulse wave velocity, whole blood viscosity, platelet activation and plasma markers of inflammation.

NCT ID: NCT01367028 Completed - Breast Cancer Clinical Trials

A Phase II Study of Neoadjuvant Trastuzumab+Docetaxel+NPLD+/-Bevacizumab in Her2-pos. Early Breast Cancer

ABCSG 32
Start date: June 2011
Phase: Phase 2
Study type: Interventional

Multicenter randomised phase II study of neoadjuvant therapy in HER2 positive early breast cancer. Primary aim is to evaluate the cardiac toxicity of the combined treatment (trastuzumab, docetaxel, bevacizumab, NPLD) in comparison to the standard therapy.

NCT ID: NCT01363752 Completed - Clinical trials for Kidney Transplantation

A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.

ADHERE
Start date: March 8, 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.

NCT ID: NCT01363388 Completed - Vasculitis Clinical Trials

A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Vasculitis

Start date: September 2011
Phase: Phase 2
Study type: Interventional

The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody vasculitis (AAV). The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide or rituximab.

NCT ID: NCT01363011 Completed - HIV Infections Clinical Trials

Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment

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

This study is to characterize the effect of cobicistat-based regimens on parameters of renal function in subjects with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.

NCT ID: NCT01362569 Completed - Acute Renal Failure Clinical Trials

Endotoxin, Neutrophil Function and Albumin in Renal Insufficiency

ENARI
Start date: July 2011
Phase: N/A
Study type: Observational

Chronic kidney disease is widespread in the western world with bacterial infection and sepsis as common complication. It has been shown that innate immune defence, represented by dysfunction of neutrophil granulocytes, is impaired in chronic kidney disease. Another impact of chronic kidney disease on innate immunity is the chronic activation of neutrophils leading to high levels of inflammatory cytokines, thus contributing to protein oxidation. Oxidation of human serum albumin (HSA), the major plasma protein, occurs in chronic kidney disease and leads to further activation of neutrophils. Another important impact of HSA oxidation is the decrease of its binding capacity leading to impaired detoxification ability of albumin. This includes reduced clearance of endotoxin, a major component of the gram negative bacterial cell wall. Circulating endotoxin is recognized by complex formation with lipopolysaccharide binding protein (LBP) followed by binding to CD14 and toll-like receptor (TLR) 4. High systemic endotoxin levels occur in chronic kidney disease and may be the result of decreased clearance ability of HSA and increased gut permeability in combination with intestinal bacterial overgrowth. High systemic endotoxin is associated with worse outcome in several diseases and could be used as predictor for mortality in chronic kidney disease patients. Endotoxemia in renal insufficiency leads to impaired neutrophil function and to increased albumin oxidation. Oxidized albumin is not able to bind endotoxin adequately any more, which leads to a further increase in oxidative stress and neutrophil dysfunction, resulting in a vicious cycle. 195 patients with renal dysfunction will be enrolled and divided into 5 groups. Additionally, samples of 25 age and sex-matched healthy controls will be collected. This concept will change the understanding of several aspects of chronic kidney disease and will potentially help to stratify patients into different groups at risk according to their endotoxin status, and their immune and albumin dysfunction. The results of this study will have important implications into the development of novel therapeutic strategies

NCT ID: NCT01362556 Completed - Cardiac Arrest Clinical Trials

Blood Gas Analysis and Buffering In Cardiac Arrest

BABICA
Start date: March 2011
Phase: N/A
Study type: Interventional

The debate over the administration of sodium bicarbonate in cardiac arrest has been going on for several decades, swinging like a pendulum from "first-line drug" to "not indicated" to the recent guidelines advocating "a small bolus under special conditions (metabolic acidosis, intoxication, long-term resuscitation)". A targeted, blood-gas controlled application under optimised ventilation conditions has not yet been evaluated prehospitally. Our preliminary studies have shown that an arterial puncture/line as well as measurement of blood gases is feasible in preclinical conditions. This multicentre trial including 5 centres and 10 physician-staffed emergency systems is designed to compare, in a prospective randomised controlled study, the effect of a calculated dosage of sodium bicarbonate based on the patient´s base deficit and weight, on ROSC (= return of spontaneous circulation) and on the secondary survival of cardiac arrest patients. The null hypothesis is that there is no or negative impact on survival.

NCT ID: NCT01362140 Completed - MDS Clinical Trials

Darbepoetin Alfa in Patients With Anemic Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Start date: December 21, 2011
Phase: Phase 3
Study type: Interventional

The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS.

NCT ID: NCT01360554 Completed - Clinical trials for Non-Small Cell Lung Cancer (NSCLC)

ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

ARCHER 1009
Start date: June 2011
Phase: Phase 3
Study type: Interventional

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

NCT ID: NCT01360008 Completed - Arrhythmia Clinical Trials

FREEZE Cohort Study

Start date: April 2011
Phase:
Study type: Observational

Safety and efficacy in radiofrequency (RF) or cryoballoon atrial fibrillation (AF) ablation will be investigated in a cohort study design in experienced electrophysiologic (EP) centers analyzing propensity-matched cohorts.