Search results for " trials"
showing 10 items of 932 documents
Natalizumab: a country-based surveillance program
2008
Natalizumab is a humanized monoclonal antibody with a selective adhesion-molecule inhibitor effect, and a demonstrated efficacy in decreasing the frequency of relapses and progression of disability in relapsing-remitting multiple sclerosis (RR MS). After the approval of FDA and EMEA in MS cases unresponsive to immunomodulating therapy or in severe MS patients also not previously treated with interferons, and considering the concern on the possible side effects, an accurate program of surveillance was organized in our country by a combined effort of AIFA, Cineca, Department of Pharmacology of University of Bologna, and a group of neurologists appointed by the National Society of Neurology (S…
A Prognostic Enrichment Strategy for Selection of Patients With Acute Respiratory Distress Syndrome in Clinical Trials.
2019
Incomplete or ambiguous evidence for identifying high-risk patients with acute respiratory distress syndrome for enrollment into randomized controlled trials has come at the cost of an unreasonable number of negative trials. We examined a set of selected variables early in acute respiratory distress syndrome to determine accurate prognostic predictors for selecting high-risk patients for randomized controlled trials.A training and testing study using a secondary analysis of data from four prospective, multicenter, observational studies.A network of multidisciplinary ICUs.We studied 1,200 patients with moderate-to-severe acute respiratory distress syndrome managed with lung-protective ventil…
Stratification for Identification of Prognostic Categories In the Acute RESpiratory Distress Syndrome (SPIRES) Score.
2021
OBJECTIVES: To develop a scoring model for stratifying patients with acute respiratory distress syndrome into risk categories (Stratification for identification of Prognostic categories In the acute RESpiratory distress syndrome score) for early prediction of death in the ICU, independent of the underlying disease and cause of death. DESIGN: A development and validation study using clinical data from four prospective, multicenter, observational cohorts. SETTING: A network of multidisciplinary ICUs. PATIENTS: One-thousand three-hundred one patients with moderate-to-severe acute respiratory distress syndrome managed with lung-protective ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN …
Assessing age and gender in studies of breakthrough pain medications
2014
AbstractObjective:The present review was performed to identify possible differences observed between adults and elderly patients and between males and females in randomized clinical trials of breakthrough pain (BTP).Methods:A systematic search of the existing literature from 1998 to September 2013 was performed. Randomized clinical trials reporting data on older patients were selected.Results:Sixteen comparative studies were selected. The age range of inclusion criteria patients was mainly between 18–80 or ≥18 years. In some cases this data was unreported. The mean age of patients was 48–64 years, but information regarding the number of elderly patients was present in three studies only. Ge…
Prevention of haemophilic arthropathy during childhood. May common orthopaedic management be extrapolated from patients without inhibitors to patient…
2008
We recommend prophylaxis in haemophilic children with an inhibitor as a way of preventing the musculoskeletal impairment that is likely to affect them. This approach has been used for children without inhibitors with excellent results. If prophylaxis is not feasible, we suggest that intensive on-demand treatment should be given. Two agents, recombinant activated FVII (rFVIIa) and activated prothrombin complex concentrates (aPCC), are currently used to control haemostasis either for prophylaxis or intensive on-demand treatment. As it is recombinant, rFVIIa would seem more appropriate to be employed in children. aPCC could be used in adults, or in the event of an unsatisfactory response to rF…
Interferon as treatment for acute hepatitis C
1996
The efficacy of short-course (three months), low-dose (3 million units three times a week) interferon as treatment for acute hepatitis C was evaluated in a meta-analysis of controlled trials. Nine studies (five randomized and four nonrandomized) found by MEDLINE search were eligible for analysis. The outcomes assessed were the rate of patients with normal serum aminotransferases (all trials) and without HCV RNA in blood (five trials) after posttreatment follow-up. Eight trials compared interferon to no treatment, and one compared different schedules of interferon. The methodological quality of the studies was high. However, all trials had been planned for a short-term evaluation based on bi…
Long-term sequential deferiprone-deferoxamine versus deferiprone alone for thalassemia major patients: a randomised clinical trial
2009
A multicentre randomized open-label trial was designed to assess the effectiveness of long-term sequential deferiprone–deferoxamine (DFO–DFP) versus DFP alone to treat thalassaemia major (TM). DFP at 75 mg/kg, divided into three oral daily doses, for 4 d/week and DFO by subcutaneous infusion (8–12 h) at 50 mg/kg per day for the remaining 3 d/week was compared with DFP alone at 75 mg/kg, administered 7 d/week during a 5-year follow-up. The main outcome measures were differences between multiple observations of serum ferritin concentrations. Secondary outcomes were survival analysis, adverse events, and costs. Consecutive thalassaemia patients (275) were assessed for eligibility; 213 of these…
Sociodemographic, Lifestyle and Medical Factors Associated with Helicobacter Pylori Infection
2020
Background and Aims: The prevalence of Helicobacter pylori (H. pylori) infection is higher in developing countries and is often linked to lower socioeconomic status. Few studies have investigated the association between H. pylori and individual level characteristics in Europe, where several countries have a high prevalence of H. pylori infection. The study aimed to identify risk factors for H. pylori infection among adults in a large clinical trial in Latvia.
 Methods: 1,855 participants (40-64 years) of the “Multicenter randomized study of H. pylori eradication and pepsinogen testing for prevention of gastric cancer mortality” (GISTAR study) in Latvia tested for H. pylori IgG antibodi…
Single-Sided Deafness: Impact of Cochlear Implantation on Speech Perception in Complex Noise and on Auditory Localization Accuracy.
2017
Objective To assess auditory localization accuracy and speech reception threshold (SRT) in complex noise conditions in adult patients with acquired single-sided deafness, after intervention with a cochlear implant (CI) in the deaf ear. Study design Nonrandomized, open, prospective patient series. Setting Tertiary referral university hospital. Patients Eleven patients with late-onset single-sided deafness (SSD) and normal hearing in the unaffected ear, who received a CI. All patients were experienced CI users. Intervention Unilateral cochlear implantation. Main outcome measures Speech perception was tested in a complex multitalker equivalent noise field consisting of multiple sound sources. …
Predicting Early and Sustained Virological Responses in Prior Nonresponders to Pegylated Interferon alpha-2b Plus Ribavirin Retreated With Peginterfe…
2013
GOALS: To evaluate the predictive value of complete early virological response (cEVR) on sustained virological response (SVR) following retreatment with peginterferon alpha-2a (40 kDa) plus ribavirin in previous nonresponders to peginterferon alpha-2b (12 kDa). BACKGROUND: In the randomized multinational retreatment with Pegasys in patients not responding to PegIntron therapy study, a 72-week regimen of peginterferon alpha-2a (40 kDa) plus ribavirin improved SVR rates over a standard 48-week regimen in previous nonresponders to peginterferon alpha-2b (12 kDa). cEVR, defined as hepatitis C virus RNA <50 IU/mL at treatment week 12, was an important predictor of SVR. STUDY: We conducted an exp…