Search results for "endpoint"
showing 10 items of 437 documents
Sentinel Lymph Node in Aged Endometrial Cancer Patients “The SAGE Study”: A Multicenter Experience
2021
ObjectiveThe incidence of endometrial cancer is increasing in elderly people. Considering that aging progressively affects lymphatic draining function, we aimed to define its impact on IGC uptake during SLN mapping.MethodsA multicenter retrospective cohort of endometrial cancer patients with apparently early-stage endometrial cancer undergoing complete surgical staging with SLN dissection was identified in four referral cancer centers from May 2015 to March 2021. Patients were classified in Group 1 (<65 years old) and Group 2 (≥65 years old). The primary endpoint was the assessment of the overall, bilateral, and unsuccessful SLN mapping in the two groups. Secondary outcomes were the …
Ezetimibe, cardiovascular risk and atherogenic dyslipidaemia.
2010
Ezetimibe is a selective cholesterol absorption inhibitor with an excellent side-effect profile, able to reduce low-density lipoprotein (LDL) cholesterol by 15-25% from baseline in monotherapy and on top of statins and fibrates. Yet, it seems that ezetimibe produces quantitative rather than qualitative changes in LDL, with small net effects on atherogenic dyslipidaemia. This is supported by findings from the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) study on atherosclerosis progression, where the addition of ezetimibe to simvastatin in patients with heterozygous familial hypercholesterolaemia did not affect the mean change in carotid int…
Late Breaking Abstract - Dose-ranging study of mepolizumab in eosinophilic COPD
2018
Background: Patients with eosinophilic COPD & frequent exacerbations may benefit from mepolizumab (MEP) treatment. Objective: Assess efficacy & safety of 2 MEP doses vs placebo (PBO) in COPD with blood eosinophils ≥150 cells/µL [screening] or ≥300 cells/µL [prior yr], history of ≥2 moderate/≥1 severe exacerbations & ICS+≥2 bronchodilator maintenance therapies (ICS+MT). Methods: Phase III, randomised, PBO-controlled, double-blind, parallel-group trial (METREO); patients received SC MEP 100mg, MEP 300mg or PBO plus ICS+MT, every 4 wks for 52 wks. Primary endpoint: rate/yr of moderate (systemic corticosteroids/antibiotics)/severe(hospitalisation or death) exacerbations. Secondary endpoints inc…
Prognosis of adults with left ventricular non compaction: Results from a prospective multricentric french study
2021
Background Left ventricular non compaction (LVNC) is a rare cause of cardiomyopathy related to abnormal in utero myocardial development, leading to prominent trabeculations. Its prognosis remains unclear with conflicting data and mortality ranging from 2 to 38%. Purpose The aim of this study was to define the prognosis of newly diagnosed LVNC as compared to recently diagnosed dilated cardiomyopathy (DCM). Methods A prospective multicentric study with a 2-year follow-up was designed. The primary endpoint combined cardiovascular death, heart transplantation and hospitalisation for cardiovascular events. Three groups of patients were defined: Group A: new cases of LVNC, Group B: new cases of D…
Proteinuria-Microalbuminuria in Renal Damage
2015
Proteinuria (P) usually results from an insult in the glomerular and/or tubular structures of the kidney. It has been considered a marker of risk not only to develop renal insufficiency but also to suffer cardiovascular events, based on prospective studies carried out in the general population as well as in diabetic and hypertensive patients [1]. In fact, proteinuria has been considered a strong marker of risk and an intermediate endpoint during treatment [2, 3].
Comparative Effectiveness of DPP-4 Inhibitors Versus Sulfonylurea for the Treatment of Type 2 Diabetes in Routine Clinical Practice: A Retrospective …
2018
Introduction DPP-4 inhibitors (DPP4i) and sulfonylureas are popular second-line therapies for type 2 diabetes (T2D), but there is a paucity of real-world studies comparing their effectiveness in routine clinical practice. Methods This was a multicenter retrospective study on diabetes outpatient clinics comparing the effectiveness of DPP4i versus gliclazide extended release. The primary endpoint was change from baseline in HbA1c. Secondary endpoints were changes in fasting plasma glucose, body weight, and systolic blood pressure. Automated software extracted data from the same clinical electronic chart system at all centers. Propensity score matching (PSM) was used to generate comparable coh…
Grazoprevir/elbasvir for the immediate treatment of recently acquired HCV genotype 1 or 4 infection in MSM.
2020
Abstract Background In Europe, increases in HCV infection have been observed over the last two decades in MSM, making them a key population for recently acquired HCV. Alternative combinations of direct-acting antiviral agents against early HCV infection need to be assessed. Patients and methods In this pilot trial, MSM with recently acquired genotype 1 or 4 HCV infection were prospectively included and received 8 weeks of oral grazoprevir 100 mg and elbasvir 50 mg in a fixed-dose combination administered once daily. The primary endpoint was sustained virological response evaluated 12 weeks after the end of treatment (EOT) (SVR12). Secondary endpoints were the virological characterization of…
Tumor lymphocyte immune response to preoperative radiotherapy in locally advanced rectal cancer: The LYMPHOREC study
2017
IF 7.719; International audience; Introduction: Some studies have suggested that baseline tumor-infiltrating-lymphocytes (TILs), such as CD8+ and FoxP3+ T-cells, may be associated with a better prognosis in colorectal cancer. We sought to investigate modulation of the immune response by preoperative radiotherapy (preopRT) and its impact on survival in locally advanced rectal cancer (LARC). Materials & Methods: We analyzed data for 237 patients with LARC who received RT. Density of TILS (CD8+ and FoxP3+) in intraepithelial (iTILs) and stromal compartments (sTILs) were evaluated from surgery pathological specimens and biopsies performed at baseline. The primary endpoint was to assess the impa…
Characteristics of clinical trials in rare vs. common diseases: A register-based Latvian study.
2017
Background Conducting clinical studies in small populations may be very challenging; therefore quality of clinical evidence may differ between rare and non-rare disease therapies. Objective This register-based study aims to evaluate the characteristics of clinical trials in rare diseases conducted in Latvia and compare them with clinical trials in more common conditions. Methods The EU Clinical Trials Register (clinicaltrialsregister.eu) was used to identify interventional clinical trials related to rare diseases (n = 51) and to compose a control group of clinical trials in non-rare diseases (n = 102) for further comparison of the trial characteristics. Results We found no significant diffe…
Rationale and Design of the Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure Study
2021
AIMS: Although acute heart failure (AHF) with volume overload is treated with loop diuretics, their dosing and type of administration are mainly based upon expert opinion. A recent position paper from the Heart Failure Association (HFA) proposed a step-wise pharmacologic diuretic strategy to increase the diuretic response and to achieve rapid decongestion. However, no study has evaluated this protocol prospectively. METHODS AND RESULTS: The Efficacy of a Standardized Diuretic Protocol in Acute Heart Failure (ENACT-HF) study is an international, multicentre, non-randomized, open-label, pragmatic study in AHF patients on chronic loop diuretic therapy, admitted to the hospital for intravenous …