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NCT ID: NCT02061267 Completed - Metabolic Syndrome Clinical Trials

Olive Oil and Nampt on Postprandial Inflammation and Atherosclerosis in the Setting of Metabolic Syndrome

OLNAMS
Start date: January 1, 2012
Phase: N/A
Study type: Interventional

The metabolic syndrome may be defined as the constellation of cardiovascular disease (CVD) risk factors that comprises obesity, type 2 diabetes, dyslipidemia, and hypertension. Lack of habitual physical activity and certain dietary patterns, including high-saturated fatty acids (SFA) intake, contribute to increase the risk of CVD, whereas the greatest risk reduction is related with monounsaturated fatty acids (MUFA), mainly from olive oil, and omega-3 polyunsaturated fatty acids (PUFA). Vitamin B3, as a major substrate for nicotinamide phosphoribosyltransferase (NAMPT), has also emerged as a nutritional intervention strategy for prevention of CVD. NAMPT has been shown to exert activities of central importance to cellular energetics and innate immunity. Within the cell, NAMPT is the rate-limiting step in a salvage pathway of nicotinamide adenine dinucleotide (NAD+) biosynthesis. By virtue of this role, it can regulate cellular levels of NAD+ and thereby NAD+-consuming enzymes. NAMPT is also released by a variety of cells, and elevated levels can be found in the systemic circulation of subjects with a range of inflammatory disorders. Recent evidences suggest that, primarily due to its high MUFA content, olive oil is useful as an optimal fat for the modulation of CVD risk factors in the postprandial state. In addition, NAMPT has been shown to correlate with triglycerides in the fasting plasma, and a potential regulatory role for fatty acids on NAMPT expression has been proposed. The global aim of the project is to assess whether olive oil (MUFA), compared to other dietary fatty acids (SFA and omega-3 PUFA) and in association with vitamin B3 could have benefits on NAMPT-related inflammation and atherosclerosis. We hope to provide important novel insights on the relationship among dietary fatty acids, NAD+ metabolism, and metabolic syndrome. This aim is expected to be achieved in one principal objective: To elucidate the influence of olive oil (MUFA), butter (SFA) or fish oil (omega-3 PUFA) meals supplemented by vitamin B3 on postprandial NAMPT modulation and its involvement on leukocyte inflammatory response in subjects with metabolic syndrome.

NCT ID: NCT02061098 Completed - Overweight Clinical Trials

Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects

POMEcardio
Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract. The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.

NCT ID: NCT02061085 Completed - Breast Neoplasm Clinical Trials

Monotherapy With Eribulin In Her2 Negative Metastatic Breast Cancer as a First Line Treatment

MERIBEL
Start date: July 2013
Phase: Phase 2
Study type: Interventional

Multicentre, prospective, non-controlled phase II clinical trial to evaluate the efficacy and tolerability of first line single agent Eribulin in patients with HER2-negative metastatic breast carcinoma previously exposed to taxanes for early stage. The primary objective of the study is to determine the median time to progression achieved with Eribulin. Other secondary objectives will be; overall response rate, clinical benefit rate, time to treatment progression, duration of response and toxicity profile.

NCT ID: NCT02060799 Completed - Dyspnea Clinical Trials

European Dyspnoea Survey in the EMergency Departments

EuroDEM
Start date: February 2014
Phase: N/A
Study type: Observational [Patient Registry]

Braunwald defines dyspnoea as an abnormally uncomfortable awareness of breathing. Breathing discomfort, and its varying degrees of severity, is the one of the most disturbing symptoms patients can experience; and it is one of the main complaints in the patients presenting to the Emergency Department (ED). Dyspnea has a variety of underlying etiologies, like cardiac, pulmonary or metabolic etiologies or a combination of them, since several diseases can cause dyspnea like for instance heart failure (HF), asthma and chronic obstructive pulmonary disease (COPD). Acute heart failure syndrome (AHFS) is collectively defined as a gradual or rapid change in heart failure (HF) signs and symptoms resulting in a need for urgent therapy. Heart failure (HF) is one of the most important causes of morbidity and mortality in the industrialized world. The prevalence of symptomatic HF is estimated to range from 0.4 to 2.0% in general European population. The incidence increases rapidly with age, and in Europe. Characteristics, clinical presentation, treatment, and outcomes of HF patients admitted to hospital have been adequately described, in Europe and in the United States. The Euro Heart Failure Survey (EHFS) I with 11 327 patients described the demographics of acutely hospitalized HF patients. The ADHERE registry has data on over 100 000 hospitalizations for AHF from the USA. In-hospital mortality was 4 and 7%, in ADHERE and EHFS I, respectively. This same sensation of breathlessness is what also drives patients with asthma and chronic obstructive pulmonary disease (COPD) to the ED. Chronic obstructive pulmonary disease (COPD) exacerbation accounts for approximately 1.5 million ED visits in the United States per year. It is the third most common cause of hospitalization, with an estimated 726 000 hospitalizations in 2000 in the USA. Previous studies have demonstrated important differences between guideline recommendations and actual management of COPD exacerbation, either in the ED or during hospitalization. The diagnosis in front of a dyspneic patient in the ED remains a challenge, because of a low sensitivity of the clinical signs associated with the aging of the population and the variety of underlying diseases. Little is known about the Epidemiology of dyspneic patients in the ED at the European level. Diagnosis, prevalence and treatment of the patients may vary among European countries.

NCT ID: NCT02060682 Completed - Clinical trials for Coronary Artery Disease

Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice

ADVANCE-EU
Start date: February 2014
Phase:
Study type: Observational [Patient Registry]

This registry will collect real-world clinical evidence on the performance, safety, and usability of the ACIST CPM System and NAVVUS Catheter when used in accordance with approved labeling in a European commercial setting. Up to 60 subjects will have Fractional Flow Reserve (FFR) measurements of coronary lesions attempted with the CPM System and NAVVUS Catheter. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.

NCT ID: NCT02060526 Completed - Sanfilippo Syndrome Clinical Trials

Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of rhHNS Administration Via an IDDD in Pediatric Patients With Early Stage MPS IIIA Disease

Start date: February 26, 2014
Phase: Phase 2
Study type: Interventional

Sanfilippo syndrome Type A, or Mucopolysaccharidosis (MPS) IIIA, is a rare lysosomal storage disease caused by deficiency of the enzyme heparan N-sulfatase (sulfamidase). In the absence of this enzyme, there is an accumulation of the glycosaminoglycan, heparan sulfate, resulting in progressive neurodegeneration. Symptoms are usually first noted in the 1st or 2nd year of life, although definitive diagnosis is often delayed, with an average age of diagnosis of 4.5 years. The disease is characterized by developmental delays initially, followed by neurological developmental arrest, then regression. These developmental deficits are typically associated with severe behavioral disturbances. Patients have a significantly reduced lifespan, with few surviving beyond the 2nd or 3rd decade. The purpose of this study is to evaluate the safety and efficacy of recombinant human heparan-N-sulfatase (rhHNS) in pediatric patients with Early Stage Mucopolysaccharidosis Type III A Disease.

NCT ID: NCT02060396 Completed - Healthy Volunteers Clinical Trials

Study of Biochemical Markers to Determine the Acetylsalicylic Acid Chemopreventive Effect Through Antiplatelet Action

Start date: April 2013
Phase: Phase 1
Study type: Interventional

This study in healthy volunteers is the first step in developing a collaborative research program, which seeks to test the hypothesis that chemopreventive effect of acetylsalicylic acid (ASA) on colon cancer is due predominantly to its antiplatelet effect. The following features of the clinical evidence are consistent with the platelet-mediated hypothesis: 1. The apparent saturability of the chemopreventive effect of ASA at low doses given once daily, found in long-term analyses of cardiovascular and adenoma recurrence randomized clinical trial, as well as in the vast majority of observational studies performed in different settings and with different methodology. A remarkably similar saturability of the cardioprotective effect of low dose ASA given once daily is explained by the irreversible nature of cyclooxygenase (COX)-1 inactivation in platelets, and limited capacity of human platelets for de novo protein synthesis. 2. Given the short half-life of ASA in the human circulation (approximately 20 min) and the capacity of nucleated cells to resynthesize the acetylated COX-isozyme(s), it seems unlikely that a nucleated target could be suppressed throughout the 24-h dosing interval. 3. One of the cardiovascular randomized clinical trial (Thrombosis Prevention Trial) in which the chemopreventive effect of ASA was detected on long-term follow-up, involved the administration of a controlled-release formulation of ASA (75 mg) with negligible systemic bioavailability. 4. Enhanced platelet activation and thromboxane (TX)A2 generation in vivo has been demonstrated in patients with colorectal cancer and in Familial Adenomatous Polyposis patients. So, the main objective of this study is to assess the extent of acetylation at serine-529 of platelet COX-1 after the 1st and 7th dose of low-doseof enteric-coated ASA 100 mg daily. Changes of this novel biomarker of ASA action will be correlated to other known parameters of ASA PK and PD: i) Tmax, Cmax and AUC of ASA and salicylate in the peripheral circulation after oral dosing; ii) time to obtain the maximal antiplatelet effect by ASA and its persistence throughout the dosing interval as assessed by measuring the inhibition of platelet COX-1 activity in whole blood ex vivo, the inhibition of platelet aggregation in whole blood ex vivo and the inhibition of the systemic generation of TXB2.

NCT ID: NCT02060045 Completed - Clinical trials for Ventilator-associated Pneumonia

Prevention Ventilator Associated Pneumonia

REINA
Start date: November 2009
Phase: N/A
Study type: Interventional

The objective of the investigators work was to evaluate the impact of 4 sequentially implemented measures for preventing VAP in a major heart surgery ICU. The measures were a specific training program, aspiration of subglottic secretions (ASS), introduction of an inclinometer to improve the semirecumbent position, and reinforcement of oral care with chlorhexidine.

NCT ID: NCT02059291 Completed - Clinical trials for Hereditary Periodic Fevers

Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

Start date: June 27, 2014
Phase: Phase 3
Study type: Interventional

This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.

NCT ID: NCT02058589 Completed - Herpes Zoster Clinical Trials

Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant

Start date: March 20, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.