Search results for "adverse effect"
showing 10 items of 1065 documents
Lamotrigine use in pregnancy and risk of orofacial cleft and other congenital anomalies
2016
Objective: To test previous signals of a risk of orofacial cleft (OC) and clubfoot with exposure to the antiepileptic lamotrigine, and to investigate risk of other congenital anomalies (CA).Methods: This was a population-based case–malformed control study based on 21 EUROCAT CA registries covering 10.1 million births (1995–2011), including births to 2005 in which the clubfoot signal was generated and a subsequent independent study population of 6.3 million births. A total of 226,806 babies with CA included livebirths, stillbirths, and terminations of pregnancy following prenatal diagnosis. First-trimester lamotrigine monotherapy exposure in OC cases and clubfoot cases was compared to other …
P463 COVID-19 vaccination willingness and hesitancy in patients with Inflammatory Bowel Diseases (IBD): analysis of determinants in a national survey…
2021
Abstract Background Vaccine hesitancy, the delay in acceptance or refusal of vaccination despite its availability, represents a threat to the diffusion and lethality of infectious diseases. COVID-19 vaccination has been recommended by national and international organizations in patients with Inflammatory Bowel Diseases (IBD). The aim of the study was to evaluate COVID-19 vaccine willingness and hesitancy in a population of Italian patients with IBD, and their determinants. Methods In February 2021 an online questionnaire focused on COVID-19 vaccine was proposed to a representative sample of Italian IBD patients. Socio-demographic characteristics, IBD features, lifestyle, perception of COVID…
The effect of bergamot on dyslipidemia
2016
Abstract Background Statins are the most common used lipid lowering drugs but they may cause adverse effects and despite their well-established therapeutic benefits residual cardiovascular (CV) risk remains. The use of other lipid lowering drugs and nutraceuticals alone or as add-on lipid-modifying therapy can be an option in such cases. Several studies have reported health-related properties of the Citrus fruits, among which bergamot (Citrus bergamia Risso) differs from others by particularly high content of certain compounds. Purpose This narrative review summarizes the current evidence on the effects of bergamot on lipid parameters based on studies involving animals and humans. Main evid…
Safety Evaluation of α-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies
2020
Alpha-lipoic acid (ALA) is a natural short-chain fatty acid that has attracted great attention in recent years as an antioxidant molecule. However, some concerns have been recently raised regarding its safety profile. To address the issue, we aimed to assess ALA safety profile through a systematic review of the literature and a meta-analysis of the available randomized placebo-controlled clinical studies. The literature search included EMBASE, PubMed Medline, SCOPUS, Google Scholar, and ISI Web of Science by Clarivate databases up to 15th August 2020. Data were pooled from 71 clinical studies, comprising 155 treatment arms, which included 4749 subjects with 2558 subjects treated with ALA an…
Random allogeneic blood transfusion in pigs: characterisation of a novel experimental model.
2019
BackgroundOrgan cross-talk describes interactions between a primary affected organ and a secondarily injured remote organ, particularly in lung-brain interactions. A common theory is the systemic distribution of inflammatory mediators that are released by the affected organ and transferred through the bloodstream. The present study characterises the baseline immunogenic effects of a novel experimental model of random allogeneic blood transfusion in pigs designed to analyse the role of the bloodstream in organ cross-talk.MethodsAfter approval of the State and Institutional Animal Care Committee, 20 anesthetized pig were randomized in a donor and an acceptor (eachn = 8): the acceptor animals …
One-Year Outcome of Glycoprotein IIb/IIIa Inhibitor Therapy in Patients with Myocardial Infarction-Related Cardiogenic Shock
2021
Background: We aimed to evaluate the effect of intravenous glycoprotein IIb/IIIa receptor inhibitors (GPIs) on in-hospital survival and mortality during and at the 1-year follow-up in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI) complicated by cardiogenic shock (CS), who were included in the Polish Registry of Acute Coronary Syndromes (PL-ACS). Methods: From 2003 to 2019, 466,566 MI patients were included in the PL-ACS registry. A total of 10,193 patients with CS received PCI on admission. Among them, GPIs were used in 3934 patients. Results: The patients treated with GPIs were younger, had lower systolic blood pressure on admission, required i…
Cost-efficacy of oral triptans in the treatment of acute migraine
2005
SummaryThe objective of this study was to compare the efficiency of oral triptans currently used in the treatment of acute migraine in Spain. Using a decision analytic model, a cost-efficacy analysis was performed from the payer's perspective. Efficacy was assessed in terms of sustained pain-free patients, with data extracted from a recent meta-analysis of clinical trials. Chest-related and central nervous system-related adverse events were also considered. For the economic analysis, the cost of drug treatment and the management of adverse events were determined.A group of three triptans (naratriptan 2.5 mg, sumatriptan 50 mg and almotriptan 12.5 mg) was found to dominate all other triptans…
Phase II Study of Taselisib (GDC-0032) in Combination with Fulvestrant in Patients with HER2-Negative, Hormone Receptor–Positive Advanced Breast Canc…
2018
AbstractPurpose: This single-arm, open-label phase II study evaluated the safety and efficacy of taselisib (GDC-0032) plus fulvestrant in postmenopausal women with locally advanced or metastatic HER2-negative, hormone receptor (HR)-positive breast cancer.Patients and Methods: Patients received 6-mg oral taselisib capsules daily plus intramuscular fulvestrant (500 mg) until disease progression or unacceptable toxicity. Tumor tissue (if available) was centrally evaluated for PIK3CA mutations. Adverse events (AE) were recorded using NCI-CTCAE v4.0. Tumor response was investigator-determined using RECIST v1.1.Results: Median treatment duration was 4.6 (range: 0.9–40.5) months. All patients expe…
Topical application of the Wnt/β-catenin activator methyl vanillate increases hair count and hair mass index in women with androgenetic alopecia
2016
Activation of the WNT/β-catenin pathway has emerged as a potential therapeutic target in androgenetic alopecia (AGA). Methyl vanillate (MV) - a safe plant-derived ingredient - has been recently shown to activate the WNT/β-catenin signaling. Objectives Two distinct substudies were conducted. First, we designed a 6-month, uncontrolled, open-label clinical study to investigate whether topically applied MV may increase hair count and hair mass index (HMI) in female AGA. Second, we conducted a molecular study on the effect of MV on WNT10B mRNA expression in scalp biopsies of women with AGA. A total of 20 Caucasian women (age range: 25-57 years) with AGA (Sinclair grade 1-2) were included. The re…
Clinical-anamnestic and instrumental data in outpatients suffering from venous disease
1995
The authors studied 200 consecutive outpatients with symptoms due to venous disease of the lower limbs. All the patients underwent anamnestic, clinical and instrumental evaluation (c.w. Doppler velocimetry and strain-gauge plethysmography). The results of this study showed that some anamnestic and clinical data are significantly related to venous disease detected by instrumental techniques. The superficial and deep vein hypertension were, instead, correlated to oral contraceptive use.