Search results for "Adverse effect"
showing 10 items of 1065 documents
A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic ha…
2021
BACKGROUND: Cytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients. METHODS: In this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who re…
Acetyl-L-Carnitine Supplementation and the Treatment of Depressive Symptoms: A Systematic Review and Meta-Analysis.
2017
Objective: Deficiency of acetyl-l-carnitine (ALC) seems to play a role in the risk of developing depression, indicating a dysregulation of fatty acid transport across the inner membrane of mitochondria. However, data about ALC supplementation in humans are limited. We thus conducted a systematic review and meta-analysis investigating the effect of ALC on depressive symptoms across randomized controlled trials (RCTs). Methods: A literature search in major databases, without language restriction, was undertaken from inception until 30 December 2016. Eligible studies were RCTs of ALC alone or in combination with antidepressant medications, with a control group taking placebo/no intervention or…
Pruritus precipitated by hydroxyethyl starch: a review.
2005
Summary Hydroxyethyl starch (HES) is widely used for fluid management in broad populations of patients, particularly in the surgery and intensive care settings. Pruritus, often manifested as pruritic crises, is increasingly being recognized as a common major adverse effect of HES administration. This iatrogenic form of pruritus is frequently severe and protracted with a serious negative impact on patient quality of life, including sleep disturbance, disruption of daily routine and mental distress. Such pruritus is generally refractory to available therapies and can persist for up to 12–24 months. All currently clinically available HES solutions entail the risk of pruritus, including those o…
Anti-Tumour Necrosis Factor-?? Therapy for Rheumatoid and Other Inflammatory Arthropathies
2006
Anti-tumour necrosis factor (TNF)-alpha represents a major advance in the treatment of rheumatoid arthritis (RA), ankylosing spondylitis and psoriatic arthritis. It is usually well tolerated, but a potential increase in the incidence of some infections in patients taking anti-TNFalpha agents has been reported. Compared with younger people, elderly patients have more co-morbidities and are likely to be taking more medications. Moreover, the aging process induces an increase in the rate of infections. Nevertheless, in recent studies analysing the databases of etanercept trials, the normalised incidence of adverse events, serious adverse events, medically important infections and deaths was no…
Efficacy of adalimumab as second-line therapy in a pediatric cohort of Crohn’s disease patients who failed infliximab therapy: the Italian Society of…
2019
Patrizia Alvisi,1 Serena Arrigo,2 Salvatore Cucchiara,3 Paolo Lionetti,4 Erasmo Miele,5 Claudio Romano,6 Alberto Ravelli,7 Daniela Knafelz,8 Stefano Martelossi,9 Graziella Guariso,10 Salvatore Accomando,11 Giovanna Zuin,12 Costantino De Giacomo,13 Lucio Balzani,14 Monia Gennari,15 Marina Aloi3 On behalf of the SIGENP IBD Working Group 1Pediatric Gastroenterology Unit, Pediatric Department, Maggiore Hospital, Bologna, Italy; 2Pediatric Gastroenterology and Endoscopy Unit, G Gaslini Children’s Hospital, Genoa, Italy; 3Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Rome, Italy; 4Gastroenterology and Nutrition Unit, Meyer Children’s Hospital, Florenc…
Posaconazole vs Standard Azole (FLU/ITRA) Therapy for Prophylaxis of Invasive Fungal Infections (IFIs) among High-Risk Neutropenic Patients: Results …
2005
Abstract Background: Patients with severe and prolonged neutropenia are at high-risk of developing life-threatening IFIs. Despite current treatment option, IFIs are difficult to treat and frequently associated with high mortality rates. Antifungal prophylaxis has shown benefits in high-risk populations and is a standard practice in many institutions. We compared Posaconazole (POS), a new broad-spectrum triazole, vs Standard Azoles for the prevention of IFIs in patients with a new diagnosis or first relapse of acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) being treated with intensive chemotherapy. Methods: Patients in this randomized, evaluator-blinded, active controlled…
Methadone versus morphine for postoperative pain in patients undergoing surgery for gynecological cancer: A randomized controlled clinical trial.
2020
Abstract Study objective The aim of this study was to compare methadone and morphine for the management of postoperative. Design Open, controlled study. Setting Postoperative recovering area, ward. Patients Sixty-four patients, ASA I-III, undergoing gynecological surgery for cancer. Interventions Morphine or methadone 0.15 mg/kg given preoperatively. After operation an intravenous morphine or intravenous methadone infusion at doses of 12 mg/day was started. Measurements Pain intensity and opioid consumption. Main results Methadone infusion provided a better analgesia in comparison with morphine infusion on the second day. Opioid consumption was significantly lower in the methadone group. No…
Adverse effects of iodine thyroid blocking: a systematic review
2011
(131)I, when released in a radiological or nuclear accident as happened recently in Fukushima, Japan, may cause thyroid cancer as a long-term consequence. Iodine thyroid blocking (ITB) is known to reduce the risk of developing thyroid cancer. Potential adverse effects of ITB have not been systematically investigated so far. This article summarises the results of a review on adverse effects of ITB based on a systematic literature search in scientific medical databases. A meta-analysis was not performed as identified studies displayed major heterogeneity. The search resulted in 14 articles relevant to the topic, reporting mostly on surveys, ecological and intervention studies. Only one study …
Transcranial direct current stimulation: Adverse effects and the efficacy of a commonly utilised sham protocol
2017
IntroductionTranscranial direct current stimulation (tDCS) is a promising neuromodulation method that has, for example, been used to treat depression. Nevertheless, the adverse effects of tDCS and the validity of the current standard tDCS sham protocols have received limited attention.ObjectivesTo evaluate the extent and types of tDCS adverse effects and to assess the reliability of sham stimulation as a control procedure for tDCS in a double-blind setting.AimsTo compare adverse effects between tDCS and sham stimulation groups, and to determine how well the participants and the experimenter are able to distinguish tDCS from sham stimulation.MethodsA sample of healthy volunteers received a 2…
Clinical and Morphologic Predictors of Outcome in a Multicenter Cohort of ITP Patients Treated with Trombopoietin Analogues
2018
Abstract Background: The role of bone marrow response in patients with immune thrombocytopenia (ITP) has gained paramount importance since the last 10 years, with the demonstrations that marrow megakaryocytes (MGK) are unable to properly compensate platelets peripheral destruction. TPO receptor agonists (TPOa), namely romiplostim (ROMI) and eltrombopag (EPAG), by stimulating megakaryopoiesis are able to induce a response in 74% to 94% of cases in clinical trials. However, real world use of these drugs has shown frequent changes in individual dose requirement, the possibility of treatment discontinuation, and their effectiveness outside registered indications; moreover, nothing is known abou…