Search results for "Mace"

Self‐management of immunomodulatory drug treatment in multiple myeloma patients

2019

Objective Immunomodulatory drugs (IMIDs: thalidomide, lenalidomide and pomalidomide) are widely used in patients with multiple myeloma (MM). The aim of our study was to validate a questionnaire to evaluate the self-capacity of MM patients to manage IMID treatment including side effects. Methods We used a method adapted from the recommendations of the European Organisation for Research and Treatment of Cancer (EORTC) to validate a French questionnaire for patients with MM treated with IMIDs. Results The face validity was evaluated in 15 patients and the construct validity in 56 patients. For discriminant validity, two groups were constituted by gender and depending on whether they had a prev…

Media-fill simulation tests in manual and robotic aseptic preparation of injection solutions in syringes

2014

Objective The purpose of this study was to evaluate the contamination rate of media-fill products either prepared automated with a robotic system (APOTECAchemo™) or prepared manually at cytotoxic workbenches in the same cleanroom environment and by experienced operators. Media fills were completed by microbiological environmental control in the critical zones and used to validate the cleaning and disinfection procedures of the robotic system. Methods The aseptic preparation of patient individual ready-to-use injection solutions was simulated by using double concentrated tryptic soy broth as growth medium, water for injection and plastic syringes as primary packaging materials. Media fills w…

Absorption of drugs from the bladder and intravesical chemotherapy

1976

Comment on: Tocilizumab induces corticosteroid sparing in rheumatoid arthritis patients in clinical practice: reply

2015

Type de document : lettre à l'éditeur; International audience

1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease

2016

Abstract Background Coronary computed tomographic angiography (CTA) plus estimation of fractional flow reserve using CTA (FFR CT ) safely and effectively guides initial care over 90 days in patients with stable chest pain. Longer-term outcomes are unknown. Objectives The study sought to determine the 1-year clinical, economic, and quality-of-life (QOL) outcomes of using FFR CT instead of usual care. Methods Consecutive patients with stable, new onset chest pain were managed by either usual testing (n = 287) or CTA (n = 297) with selective FFR CT (submitted in 201, analyzed in 177); 581 of 584 (99.5%) completed 1-year follow-up. Endpoints were adjudicated major adverse cardiac events (MACE) …

Long-Term Clinical Outcomes After Percutaneous Coronary Intervention for Ostial/Mid-Shaft Lesions Versus Distal Bifurcation Lesions in Unprotected Le…

2013

Objectives The aim of this study was to compare, in a large all-comer registry, the long-term clinical outcomes after percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for ostial/mid-shaft lesions versus distal bifurcation lesions in unprotected left main coronary artery (ULMCA) stenosis. Background Limited data are available regarding clinical outcomes following DES implantation at the different ULMCA sites. Methods Patients with ULMCA stenosis treated by PCI with DES were analyzed in this multinational registry. Results A total of 1,612 patients were included: 482 were treated for ostial/mid-shaft lesions versus 1,130 for distal bifurcation lesions. At a median follo…

Patient preferences in the treatment of hemophilia A: impact of storage conditions on product choice

2018

Bernd Tischer,1 Renato Marino,2 Mariasanta Napolitano3 1Kantar Health, Munich, Germany; 2Haemophilia and Thrombosis Centre, University Hospital of Bari, Apulia, Italy; 3University of Palermo, Reference Regional Center for Thrombosis and Hemostasis Hematology Unit, Palermo, Italy Objectives: To gain insights into the usage of factor VIII (FVIII) products by patients diagnosed with moderate/severe hemophilia A, and to assess the impact and perceived importance of product storage.Methods: In this study, 200 patients diagnosed with moderate or severe hemophilia A across seven countries participated. Data were collected via a 30-minute, face-to-face interview in six countries and via a web-based…

The evolution of European Medicines Agency drug approval: the adaptive licensing: Table 1

2015

In March 2014, the European Medicines Agency (EMA) launched a pilot project of ‘adaptive licensing’ to speed up access to drugs in development, in order to respond to unmet medical needs. The project will involve parallel scientific advice from the regulatory agency, pharmaceutical industry, the companies Health Technology Assessment (HTAs) bodies, organisations studying guidelines on clinical treatment and patient associations. The traditional process of drug authorisation is divided into several parts, involving in vitro studies and in vivo studies in animals (preclinical studies), as well as phase 1–3 randomised controlled trials conducted in humans over a predefined period. When authori…

Gestational diabetes and the metabolic syndrome: Can obesity and small, dense low density lipoproteins be key mediators of this association?

2013

Gestational diabetes mellitus (GDM) represents a condition of glucose intolerance with first appearance or recognition at the time of a pregnancy, associated with an inadequate pancreatic response to the advanced insulin resistance of the later stages of pregnancy, and accompanied by enhancing β-cell mass and secretion of insulin. Women who had GDM exhibit a higher risk for later advent of type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD). Additionally, previous GDM has been proposed as independently correlated with higher risk for development of atherosclerosis in a healthy population, similar to the metabolic syndrome (MetS) and independently of the presence of established…

Resistin: An Inflammatory Cytokine. Role in Cardiovascular Diseases, Diabetes and the Metabolic Syndrome

2014

Resistin is an adipocyte- and monocyte-derived cytokine which has been implicated in the modulation of insulin action, energy, glucose and lipid homeostasis. Resistin has been associated with insulin resistance and many of its known complications. As a molecular link between metabolic signals, inflammation, and vascular dysfunction, resistin can be proposed as playing a significant role in the heightened inflammatory state induced by metabolic stress linked to excessive caloric intake, thus contributing to the risk for metabolic syndrome (MetS), type 2 diabetes (T2DM), and cardiovascular diseases (CVD). In this review, we highlighted the role of resistin, as an inflammatory cytokine, in the…