Search results for "double-blind"
showing 10 items of 662 documents
Sorafenib in combination with intensive chemotherapy in elderly patients with acute myeloid leukemia : results from a randomized, placebo-controlled …
2013
Purpose The prognosis of elderly patients with acute myeloid leukemia (AML) is still dismal even with intensive chemotherapy. In this trial, we compared the antileukemic activity of standard induction and consolidation therapy with or without the addition of the kinase inhibitor sorafenib in elderly patients with AML. Patients and Methods All patients received standard cytarabine and daunorubicin induction (7+3 regimen) and up to two cycles of intermediate-dose cytarabine consolidation. Two hundred one patients were equally randomly assigned to receive either sorafenib or placebo between the chemotherapy cycles and subsequently for up to 1 year after the beginning of therapy. The primary ob…
Inhaled Prostacyclin, Nitric Oxide, and Nitroprusside in Pulmonary Hypertension After Mitral Valve Replacement
2005
Abstract Objective: Pulmonary hypertension increases morbidity and mortality in patients undergoing heart surgery. Mitral valve stenosis is frequently associated with an increase in pulmonary vascular resistance (PVR). Cardiopulmonary bypass exacerbates pulmonary hypertension in patients undergoing cardiac surgery. The aim of this study was to compare the hemodynamic effects of inhaled prostacyclin and nitric oxide and the administration of i.v. nitroprusside during cardiac surgery with a clinical, pharmacodynamic dose-response, prospective, randomized, and double-blind study (Group A: inhaled prostacyclin; Group B: inhaled nitric oxide; Group C: nitroprusside). Materials and Methods: Fifty…
Evaluation of effectiveness of photobiostimulation in alleviating side effects after dental implant surgery. A randomized clinical trial
2020
Background To assess if photobiostimulation (PBS) alleviates pain intensity/duration and swelling after implant surgery. Material and Methods Sixty subjects (27 male and 33 female, with a mean age of 47,13 8.05 years) were included and randomly assigned to experimental group (implant surgery and photobiostimulation), placebo group (implant surgery and simulated photobiostimulation) and control group (implant surgery only). Inclusion criteria: subjects older than 20 years, with a healthy oral mucosa and requiring implant surgery. Exclusion criteria: pregnancy, history of implant failure, light sensitivity, metabolic deseases, consumption of antibiotics or corticosteroids in the last two week…
Impact of sublingual immunotherapy on seasonal asthma and skin reactivity in children allergic to Parietaria pollen treated with inhaled fluticasone …
2003
Immunotherapy is a recognized treatment for allergic respiratory diseases.
Non-celiac wheat sensitivity as an allergic condition: personal experience and narrative review.
2013
Non-celiac wheat sensitivity (NCWS) is a newly described clinical entity characterized by symptoms, which can involve the gastrointestinal tract, the nervous system, the skin, and other organs. There is little data on the pathogenesis of NCWS and it is probable that different pathogenic mechanisms are involved in the different clinical manifestations of the disease. The only common denominator of NCWS "syndrome" is wheat consumption: the symptoms disappear on exclusion of wheat from the diet, and reappear on wheat consumption. The objective of this study was to review our prior data regarding NCWS and to review relevant medical literature regarding NCWS, with particular attention to the hyp…
Safety of reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis-co…
2005
Objective The safety of a booster dose of a reduced-antigen-content tetanus–diphtheria–acellular pertussis (Tdap) vaccine was evaluated in adolescents previously vaccinated with five doses of acellular pertussis–containing vaccine. Study design Adolescents (n = 319) previously vaccinated with either 5 doses of diphtheria–tetanus–acellular pertussis (DTaP) (n = 193) or 4 doses of DTaP plus another acellular pertussis–containing vaccine received one dose each of Tdap and hepatitis A vaccine in a double-blinded, randomized, crossover trial. Rates of adverse events (AEs) after vaccination with Tdap versus hepatitis A and rates of local AEs among adolescents vaccinated with Tdap (sixth acellular…
Persistent cow's milk protein intolerance in infants: the changing faces of the same disease
1998
Background Recent research has shown that cow's milk protein intolerance (CMPI) often persists beyond 4 years of age. Aims To evaluate the clinical and immunological characteristics of a group of infants with persistent CMPI. Patients and methods Twelve infants (6 m, 6f) with persistent CMPI were followed up from birth until a median age of 5 years. The patients underwent CMP challenge each year to evaluate CMP-tolerance. As controls we followed 26 infants (12 m, 14 f) with CMPI that resolved within 1–2 years. Results A family history of atopic disease was found in 10/12 patients with persistent CMPI and in 10/26 controls (P < 0.01). Clinical presentation changed over time: at onset symptom…
Fermented Milk Consumption and Common Infections in Children Attending Day-Care Centers: A Randomized Trial
2016
Supplemental Digital Content is available in the text
Distinguishing the efficacy and sedative effects of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity diso…
2019
The present study investigated whether symptom reduction in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with guanfacine extended release (GXR) can be explained by sedative effects of the medication. Data from four double-blind, randomized, placebo-controlled, phase 3 trials of GXR monotherapy (1-7 mg/day; morning administration) in children (aged 6-12 years) and adolescents (aged 13-17 years) with ADHD were analyzed post hoc. Two studies used forced-dose titration and two used flexible-dose titration. Efficacy was determined using ADHD Rating Scale IV (ADHD-RS-IV) scores. Sedative treatment-emergent adverse events (TEAEs) included somnolence, sedati…
Cognitive-behavioral screening in elderly patients with new-onset epilepsy before treatment
2014
Objectives Cognitive comorbidity at epilepsy onset reflects disease severity and provides a baseline estimate of reserve capacities with regard to the effects of epilepsy and its treatment. Given the high incidence of epilepsy at an older age, this study analyzed objective and subjective cognition as well as quality of life in elderly patients with new-onset focal epilepsy before initiation of anti-epileptic treatment. Materials and methods A total of 257 untreated patients (60–95 years of age) with new-onset epilepsy underwent objective assessment of executive function (EpiTrack) and performed subjective ratings of cognition (Portland Neurotoxicity Scale) and quality of life (QoL; QOLIE-31…