Interferon β-1a (IFNβ-1a) in COVID-19 patients (INTERCOP): study protocol for a randomized controlled trial.

Background: Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking. We have identified IFNβ-1a as the most promising drug to be repurposed for COVID-19. The rationale relies on the evidence of IFNβ anti-viral activity in vitro against SARS-CoV-2 and animal models resembling SARS-CoV-2 infection and on a recent clinical trial where IFNβ was indicated as the key component of a successful therapeutic combination.

Validation of a new score for outcome prediction in patients with heart failure with reduced ejection fraction.

Background: Most models for outcome prediction in heart failure are under-utilized because complex or including non-routine clinical use variables. We aimed to develop a prognostic score for patients with stable heart failure, including only easily obtainable parameters.

Methods: In 376 outpatients with heart failure (ejection fraction ≤40%), twelve variables were individually correlated with 5-year mortality.

Gamma glutamyltransferase, alanine aminotransferase and risk of cancer: systematic review and meta-analysis.

The prospective evidence for the associations of gamma glutamyltransferase (GGT) and alanine aminotransferase (ALT) with risk of cancer in the general population is uncertain. We conducted a systematic review and meta-analysis of published prospective observational studies evaluating the associations of baseline levels of GGT and ALT with risk of overall (incidence and/or mortality) and site-specific cancers. Relevant studies were identified in a literature search of MEDLINE, EMBASE, Web of Science, reference lists of relevant studies to April 2014 and email contact with investigators.

Macular dysfunction is common in both type 1 and type 2 diabetic patients without macular edema.

Purpose: To study retinal function in asymptomatic Type 1 and Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) and no clinical signs of diabetic macular edema.

Methods: Thirty-six consecutive Type 1 and Type 2 diabetic patients with nonproliferative diabetic retinopathy and no diabetic macular edema and 28 healthy controls underwent a complete ophthalmologic examination, including spectral domain optical coherence tomography and microperimetry.

Results: Seventy-one eyes (17 patients with Type 1 and 19 with Type 2 diabetes) were tested, and data from 36 (17 Type 1 and 19 Type 2) eyes were analyzed.

Association of LOXIN, a new functional splicing isoform of the OLR1 gene, with severity and prognostic localization of critical coronary artery stenoses.

Aims: To evaluate the association between LOXIN, a new functional protective splicing isoform of the oxidized LDL receptor 1 (OLR1) gene, and the severity of coronary artery stenoses.

Methods: We analyzed 100 consecutive patients with coronary artery disease (CAD) and 100 controls, all evaluated by a new molecular biology test using highly specific allele primers able to identify the single nucleotide variation (IVS4-14 A>G) in the OLR1 gene (Loxin Test - Technogenetics). All the patients and the controls underwent coronary angiography and, for quantitative evaluation, we used both vessel and stenosis score, and SYNTAX score to evaluate the severity of CAD.

Prognostic role of stress/rest myocardial perfusion scintigraphy in patients with cardiac syndrome x.

Aim: The prognostic utility of myocardial perfusion scintigraphy (MPS) in patients with angiographically normal coronary arteries has not been evaluated yet. Our aim was to determine the prognostic role of positive MPS in patients with angina, positive exercise test and smooth coronary arteries (syndrome X).

Methods: A total of 156 patients with angina, positive exercise test, positive MPS and normal coronary arteries and 172 patients with angina and positive exercise test who had negative MPS were selected for study.

Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension.

We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial.

Effect of partial fatty acid oxidation inhibition with trimetazidine on mortality and morbidity in heart failure: results from an international multicentre retrospective cohort study.

Objectives: The aim of this cohort study was to retrospectively evaluate, in patients with chronic heart failure (CHF), the long term effect of trimetazidine (TMZ) on morbidity and mortality.

Background: Previous small studies in patients with CHF have shown that TMZ can improve left ventricular function, exercise capacity and NYHA class compared to placebo. However, no data on the effects of TMZ on survival in patients with CHF have ever been produced.

Severity and prognostic localization of critical coronary artery stenoses: correlation with clinical control of major traditional risk factors.

Purpose: To evaluate the association between the severity and angiographic localization of coronary artery stenoses and clinical control of major traditional risk factors (RF).

Methods: We analyzed 500 patients without known cardiovascular disease, undergoing coronary angiography for the diagnosis of coronary artery disease (CAD), with one or more major traditional RF, all in optimal clinical control. For the quantitative evaluation of CAD, we used a vessel and stenosis score to evaluate the severity of CAD.

Beneficial effects of beta-blockers on left ventricular function and cellular energy reserve in patients with heart failure.

Beta-blockers have been shown to improve left ventricular (LV) function in patients with heart failure. The aim of this study is to non-invasively assess, by means of in vivo 31P-magnetic resonance spectroscopy (31P-MRS), the effects of beta-blockers on LV cardiac phosphocreatine and adenosine triphosphate (PCr/ATP) ratio in patients with heart failure. Ten heart failure patients on full medical therapy were beta-blocked by either carvedilol or bisoprolol.

Insulin resistance/hyperinsulinemia and cancer mortality: the Cremona study at the 15th year of follow-up.

Type 2 diabetes is associated with risk of cancer. Hyperinsulinemia and insulin resistance may be the link with cancer, but whether this is independent of the diabetes status, obesity/visceral obesity and metabolic syndrome is uncertain and the present study wanted to address this issue. Fifteen-year all-cause, CVD and cancer mortality data were obtained through the Regional Health Registry in 2,011 out of 2,074 Caucasian middle-aged individuals of the Cremona Study, a population study on the prevalence of diabetes mellitus in Italy in which anthropometric and metabolic characteristics were collected.

Improved survival in patients with chronic mild/moderate systolic heart failure followed up in a specialist clinic.

Objective: To relate therapeutic issues, comorbidities and functional parameters to mortality/morbidity of mild/moderate heart failure patients.

Methods: From our heart failure clinic, 372 heart failure patients (269 men, aged 66 ± 11 years), with stable heart failure and ejection fraction 45% or less were recruited. Survival curves were estimated according to the Kaplan-Meier method.

High-sensitivity C-reactive protein is within normal levels at the very onset of first ST-segment elevation acute myocardial infarction in 41% of cases: a multiethnic case-control study.

Objectives: This study sought to assess the prevalence of normal levels of high sensitivity C-reactive protein (hsCRP) at the very onset of ST-segment elevation myocardial infarction (STEMI).

Background: Levels of hsCRP ≥2 mg/l identify individuals who benefit from lipid lowering and possibly anti-inflammatory agents, but how many patients develop infarction in spite of hsCRP levels <2 mg/l and thus would be ineligible for these treatments?

Methods: We studied 887 patients with unequivocally documented STEMI as the first manifestation of coronary disease and 887 matched control subjects from urban areas of Italy, Scotland, and China. Blood samples were obtained before reperfusion strategies <6 h from symptoms onset in order to limit acute event-related increases.

Resting cardiac energy metabolism is inversely associated with heart rate in healthy young adult men.

Background: 31-Phosphorus-magnetic resonance spectroscopy may provide pathophysiological insights into the high-energy phosphate metabolism of the myocardium as measured by phosphocreatine to adenosine triphosphate (PCr/ATP) ratio. Aim of the present study was to determine in vivo the relation between cardiac PCr/ATP ratio and heart rate in normal male subjects.

Methods: One hundred twelve apparently healthy, young male individuals (age 34 ± 10 years) were prospectively evaluated.

Effect of partial inhibition of fatty acid oxidation by trimetazidine on whole body energy metabolism in patients with chronic heart failure.

Objective: Trimetazidine may have beneficial effects on left ventricular (LV) function in patients with systolic heart failure. The authors assessed whether long-term addition of trimetazidine to conventional treatment could improve, along with LV function, resting whole body energy metabolism in patients with chronic systolic heart failure.

Design: Single blind randomised study.

Efficacy of trunk balance exercises for individuals with chronic low back pain: a randomized clinical trial.

Study Design: Randomized clinical trial.

Objectives: To determine the efficacy of trunk balance exercises for individuals with chronic low back pain.

Background: The majority of exercises focusing on restoring lumbopelvic stability propose targeting the feedforward control of the lumbopelvic region.

Fatty liver index and mortality: the Cremona study in the 15th year of follow-up.

Unlabelled: A fatty liver, which is a common feature in insulin-resistant states, can lead to chronic liver disease. It has been hypothesized that a fatty liver can also increase the rates of non-hepatic-related morbidity and mortality. Therefore, we wanted to determine whether the fatty liver index (FLI), a surrogate marker and a validated algorithm derived from the serum triglyceride level, body mass index, waist circumference, and γ-glutamyltransferase level, was associated with the prognosis in a population study.

Increased low-grade inflammation is associated with lack of functional response to carvedilol in patients with systolic heart failure.

Background: The aim of this study was to evaluate, according to functional response, the neuroendocrine and inflammatory status in patients with chronic heart failure before and after therapy with carvedilol.

Methods And Results: Serum tumor necrosis factor-α (TNF-α) soluble receptors (sTNF-R1 and sTNF-R2), interleukin (IL)-10 and IL-18, chromogranin A (CgA) and brain natriuretic peptide (pro-BNP) were measured in 37 New York Heart Association class II to IV heart failure patients, at baseline and after 6 months of therapy with carvedilol. Patients were divided in two groups according to whether, following carvedilol, left-ventricular ejection fraction (LVEF) had increased by at least 5% (17 patients) or not (20 patients).

Celiac plexus block for pancreatic cancer pain in adults.

Background: Pancreatic cancer causes severe pain in 50 to 70% of patients and is often difficult to treat. Celiac plexus block (CPB) is thought to be a safe and effective technique for reducing the severity of pain.

Objectives: To determine the efficacy and safety of celiac plexus neurolysis in reducing pancreatic cancer pain, and to identify adverse effects and differences in efficacy between the different techniques.

Macular micropseudocysts in early stages of diabetic retinopathy.

Purpose: To identify by noninvasive means early retinal abnormalities that may predict diabetic macular edema.

Methods: The authors analyzed retrospectively data from consecutive patients with Type 1 (n = 16) or Type 2 (n = 23) diabetes who presented for routine follow-up of early retinopathy, had no clinical signs or symptoms of diabetic macular edema, and were evaluated with spectral-domain optical coherence tomography. Age- and gender-matched nondiabetic subjects provided normative data.

Diagnostic sensitivity of thyroid autoantibodies assessed in a population-based, cross-sectional study in adults.

The aim of this study was to estimate the diagnostic sensitivity of thyroid autoantibodies in individuals with a case-mix of subjects with thyroid disease representing that of the general population. We measured thyroid microsome (TMA), thyroid peroxidase (TPO), thyroglobulin (TGA) and thyroid-stimulating hormone (TSH) receptor (TRA) autoantibodies in subjects in the bottom (hyperthyroid end) and top (hypothyroid end) four percentiles of the TSH distribution from among participants in a population-based survey of individuals aged ≥40 years (the Cremona Study). TMA and TPO were the most sensitive autoantibodies in subjects in both the bottom percentiles (19.

Prevalence, metabolic features, and prognosis of metabolically healthy obese Italian individuals: the Cremona Study.

Objective: Some obese individuals have normal insulin sensitivity. It is controversial whether this phenotype is associated with increased all-cause mortality risk.

Research Design And Methods: Fifteen-year all-cause mortality data were obtained through the Regional Health Registry for 2,011 of 2,074 Caucasian middle-aged individuals of the Cremona Study, a population study on the prevalence of diabetes in Italy.

5-year outcomes following percutaneous coronary intervention with drug-eluting stent implantation versus coronary artery bypass graft for unprotected left main coronary artery lesions the Milan experience.

Objectives: We sought to evaluate at 5 years the occurrence of cardiac death; cardiac death, and/or myocardial infarction (MI); cardiac death, MI, and/or stroke; target vessel revascularization; and major adverse cardiac and cerebrovascular events following percutaneous coronary intervention (PCI) with drug-eluting stent (DES) versus coronary artery bypass graft (CABG) in unprotected left main coronary artery lesions.

Background: Preliminary results at 1 year showed comparable occurrence of major adverse cardiac and cerebrovascular events in our center between PCI and CABG.

Methods: All consecutive patients with an unprotected left main coronary artery stenosis electively treated with DES implantation versus CABG in our center, between March 2002 and July 2004, were analyzed.

Efficacy and safety of anti-vascular endothelial growth factor (VEGF) therapy with intravitreal ranibizumab (Lucentis) for naive retinal vein occlusion: 1-year follow-up.

Purpose: To evaluate the efficacy and safety of intravitreal ranibizumab (Lucentis) in patients with treatment-naive retinal vein occlusion.

Design: Prospective, consecutive, non-comparative, interventional case series.

Participants: Seventeen eyes of 17 consecutive patients with naive retinal vein occlusion.