Search results for "STIMA"
showing 10 items of 1809 documents
Tolerability profile of thiopurines in inflammatory bowel disease: a prospective experience
2017
The occurrence of thiopurine-related adverse events (AEs) may complicate the management of patients with inflammatory bowel disease (IBD). We aimed to evaluate the tolerability of thiopurines in a current IBD setting.All consecutive patients who started a treatment with azathioprine (AZA) from January 2010 to March 2016 were entered in a prospectively maintained database, and the AEs which led to the permanent discontinuation of the drug were reported.Two hundred and fifty three patients were included. Median total follow-up was 32 months (range: 0.2-75 months). At the end of the study, AZA was discontinued in 160 patients (63.2%). The main reason leading to drug withdrawal was the occurren…
Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial.
2010
On the basis of promising results that were reported in several phase 2 trials, we investigated whether the addition of the monoclonal antibody rituximab to first-line chemotherapy with fludarabine and cyclophosphamide would improve the outcome of patients with chronic lymphocytic leukaemia.Treatment-naive, physically fit patients (aged 30-81 years) with CD20-positive chronic lymphocytic leukaemia were randomly assigned in a one-to-one ratio to receive six courses of intravenous fludarabine (25 mg/m(2) per day) and cyclophosphamide (250 mg/m(2) per day) for the first 3 days of each 28-day treatment course with or without rituximab (375 mg/m(2) on day 0 of first course, and 500 mg/m(2) on da…
One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass
2019
The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal occlusive disease.This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as the composi…
A randomized multicenter phase II study comparing capecitabine with irinotecan or cisplatin in metastatic adenocarcinoma of the stomach or esophagoga…
2009
The combination of irinotecan with 5-fluorouracil demonstrates efficacy with tolerable safety in the first-line treatment of metastatic gastroesophageal cancer (mGC). This randomized phase II trial compared for the first time capecitabine with irinotecan or cisplatin in this setting.Patients were randomly assigned to receive 3-week cycles of capecitabine 1000 mg/m(2), twice daily for 14 days, with on day 1 either irinotecan 250 mg/m(2) (XI) or cisplatin 80 mg/m(2) (XP). The primary end point was overall response rate (ORR) and secondary end points included progression-free survival (PFS), overall survival (OS) and safety.Of 118 patients recruited, 112 were eligible for safety analysis and 1…
Posaconazole vs. Fluconazole or Itraconazole Prophylaxis in Patients with Neutropenia
2007
Patients with neutropenia resulting from chemotherapy for acute myelogenous leukemia or the myelodysplastic syndrome are at high risk for difficult-to-treat and often fatal invasive fungal infections.In this randomized, multicenter study involving evaluators who were unaware of treatment assignments, we compared the efficacy and safety of posaconazole with those of fluconazole or itraconazole as prophylaxis for patients with prolonged neutropenia. Patients received prophylaxis with each cycle of chemotherapy until recovery from neutropenia and complete remission, until occurrence of an invasive fungal infection, or for up to 12 weeks, whichever came first. We compared the incidence of prove…
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…
Cytomegalovirus prevention strategies in seropositive kidney transplant recipients: an insight into current clinical practice
2015
Producción Científica
Persistence on Anti-Tumour Necrosis Factor Therapy in Older Patients with Inflammatory Bowel Disease Compared with Younger Patients: Data from the Si…
2020
BACKGROUND AND OBJECTIVE: Older people with inflammatory bowel disease (IBD) appear to have a lower response to anti-tumour necrosis factor (TNF) therapy, with more frequent complications than younger patients. The objective of this study was to assess persistence on therapy and the safety of anti-TNF therapy in older patients (aged ≥ 60 years). METHODS: We retrospectively reviewed the database of the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD), extracting data regarding IBD patients aged ≥ 60 years and controls < 60 years of age at their first course of anti-TNF treatment. Data concerning persistence on therapy over the first year of treatment (primary objective) together …
Beclomethasone dipropionate in Crohn's ileitis: A randomised, double-blind trial.
2011
Abstract Background Steroids, the mainstay of Crohn's disease treatment, have been associated with systemic side effects. Aim To evaluate the efficacy and tolerability of beclomethasone dipropionate for maintaining remission induced by a short course of systemic steroids in patients with Crohn's ileitis with or without right colonic involvement. Methods Patients (n = 84) with active Crohn's disease who achieved remission during a 2-week prednisone run-in period were randomised to receive beclomethasone dipropionate for 24 weeks or continue prednisone for a further 2 weeks followed by placebo for 22 weeks. The primary outcome was relapse rate (Crohn's Disease Activity Index score > 150 and a…
Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment o…
2011
BackgroundRadiofrequency segmental thermal ablation (RSTA) has become a commonly used technology for occlusion of incompetent great saphenous veins (GSVs). Midterm results and data on clinical parameters are still lacking.MethodsA prospective multicenteral trial monitored 295 RSTA-treated GSVs for 36 months. Clinical control visits included flow and reflux analysis by duplex ultrasound imaging and assessment of clinical parameters according to the CEAP classification and Venous Clinical Severity Score (VCSS).ResultsA total of 256 of 295 treated GSVs (86.4%) were available for 36 months of follow-up. At 36 months, Kaplan-Meier survival analysis showed the probability of occlusion was 92.6% a…