Search results for "Medd"
showing 10 items of 13 documents
Accumulated safety data of micafungin in therapy and prophylaxis in fungal diseases
2011
To define better the safety profile of micafungin, an analysis of micafungin clinical trial safety data was undertaken.Adverse event data were pooled worldwide from 17 clinical efficacy and safety studies. Adverse events were coded using the Medical Dictionary for Regulatory Activities version 5.0.In the pooled clinical trial data set, 3028 patients received at least one dose of micafungin. The mean age of patients was 41.4 years; with 296 (9.8%) children (16 years) and 387 (12.8%) elderly patients (≥ 65 years). Common underlying conditions were hematopoietic stem cell and other transplantations (26.1%), malignancies (20.8%) and HIV (32.9%). Mean exposure was 18 days for adults and 29 days …
EVOO's Effects on Incretin Production: Is There a Rationale for a Combination in T2DM Therapy?
2022
Type 2 diabetes mellitus (T2DM) is a serious public health concern as it is one of the most common chronic diseases worldwide due to social and economic developments that have led to unhealthy lifestyles, with a considerable impact both in terms of morbidity and mortality. The management of T2DM, before starting specific therapies, includes cornerstones such as healthy eating, regular exercise and weight loss. Strict adherence to the Mediterranean diet (MedDiet) has been related to an inverse association with the risk of T2DM onset, as well as an improvement in glycaemic control; in particular, thanks to the consumption of extra virgin olive oil (EVOO). Agonists of gut-derived glucagon-like…
Antioxidant and Anti-Inflammatory Potential of Polyphenols Contained in Mediterranean Diet in Obesity: Molecular Mechanisms
2021
Nutrition transition can be defined as shifts in food habits, and it is characterized by high-fat (chiefly saturated animal fat), hypercaloric and salty food consumption at the expense of dietary fibers, minerals and vitamins. Western dietary patterns serve as a model for studying the impact of nutrition transition on civilization diseases, such as obesity, which is commonly associated with oxidative stress and inflammation. In fact, reactive oxygen species (ROS) overproduction can be associated with nuclear factor-κB (NF-κB)-mediated inflammation in obesity. NF-κB regulates gene expression of several oxidant-responsive adipokines including tumor necrosis factor-α (TNF-α). Moreover, AMP-act…
ADVERSE EFFECTS OF GONADOTROPINS USED IN INFERTILITY TREATMENT
2019
Introduction: Infertility represents a problem for more and more couples all over the world, including in Romania. Thus, more and more women need to resort to drugs to treat infertility, treatments which are not without adverse reactions (Boivin et al., 2007). Modern therapy brings significant benefits in the treatment of infertility. Despite all the benefits, the controlled ovarian stimulation treatment does not lack the possibility of adverse reactions to the administered drugs.
 Objectives: The aim of this study was to determine the potential adverse reactions experienced by patients during the treatment with gonadotropins followed by assisted conception
 Methods: A study was d…
Long-term general and cardiovascular safety of tiotropium/olodaterol in patients with moderate to very severe chronic obstructive pulmonary disease
2016
Abstract Background Long-term safety, particularly cardiovascular safety, is of special interest in maintenance treatment of chronic obstructive pulmonary disease (COPD) with long-acting β 2 -agonists and long-acting muscarinic antagonists, given potential cardiovascular effects. Methods Two 52-week Phase III trials (TONADO ® ) investigated tiotropium/olodaterol (5/5 and 2.5/5 μg) versus tiotropium 2.5, 5 μg and olodaterol 5 μg. In a pre-specified safety analysis, investigator-reported treatment-emergent adverse events (AEs), electrocardiogram and laboratory data were pooled. All serious AE (SAE) reports were reviewed by an independent Adjudication Committee, which assessed whether deaths, …
Opportunistic infections in immunosuppressed patients with juvenile idiopathic arthritis: analysis by the Pharmachild Safety Adjudication Committee
2020
Background: To derive a list of opportunistic infections (OI) through the analysis of the juvenile idiopathic arthritis (JIA) patients in the Pharmachild registry by an independent Safety Adjudication Committee (SAC). Methods: The SAC (3 pediatric rheumatologists and 2 pediatric infectious disease specialists) elaborated and approved by consensus a provisional list of OI for use in JIA. Through a 5 step-procedure, all the severe and serious infections, classified as per MedDRA dictionary and retrieved in the Pharmachild registry, were evaluated by the SAC by answering six questions and adjudicated with the agreement of 3/5 specialists. A final evidence-based list of OI resulted by matching …
Riociguat treatment in patients with pulmonary arterial hypertension: Final safety data from the EXPERT registry
2021
OBJECTIVE: The soluble guanylate cyclase stimulator riociguat is approved for the treatment of adult patients with pulmonary arterial hypertension (PAH) and inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension following Phase 3 randomized trials. The EXPosurE Registry RiociguaT in patients with pulmonary hypertension (EXPERT) study was designed to monitor the long-term safety of riociguat in clinical practice. METHODS: EXPERT was an international, multicenter, prospective, uncontrolled, non-interventional cohort study of patients treated with riociguat. Patients were followed for at least 1 year and up to 4 years from enrollment or until 30 days after stopping ri…
Mediterranean, DASH, and MIND dietary patterns and cognitive function: The 2-year longitudinal changes in an older Spanish cohort
2021
Wu, L., and Sun, D. (2017). Adherence to Mediterranean diet and risk of developing cognitive disorders: an updated systematic review and meta-analysis of prospective cohort studies. Sci. Rep. 7:41317. doi: 10.1038/srep41317 Wu, Z., Phyo, A. Z. Z., Al-harbi, T., Woods, R. L., and Ryan, J. (2020). Distinct cognitive trajectories in late life and associated predictors and outcomes: a systematic review. J. Alzheimer’s Dis. Rep. 4, 459–478. doi: 10.3233/ADR-200232 Conflict of Interest: SKN was a volunteer member of the not-for profit group Plant Based Canada. JS-S reported receiving research support from the Instituto de Salud Carlos III, Ministerio de Educación y Ciencia, Departament de Salut P…
Mary and David Medd’s work: domesticity in postwar British school design (1949–72)
2021
This article focuses on the schools developed by Mary and David Medd within the Ministry of Education in Great Britain, 1949–1976. Their main contribution to the field of Educational Architecture was the definition of a design strategy known as Built-in variety, where the self-contained classrooms (empty-box-school) disappeared in favour of a variety of dissimilar places. Indeed, the Medds sustained a very innovative view from which primary educational architecture was profoundly reconceptualised, getting closer to a home than to an institution. Actually, the paper argues that it was precisely this driving principle – school as a home – that was responsible for the dismantlement of the trad…