Search results for "SCHEDULE"
showing 10 items of 567 documents
A Phase II Trial of Mitoxantrone plus Cyclophosphamide and 5-Fluorouracil in Modulation with Levo-Folinate for Advanced Breast Cancer Patients
1995
Advanced breast cancer remains a major clinical problem. Current chemotherapy regimens are able to induce a clinical response in many patients but do not appear to influence significantly patients' survival. The use of new drugs such as mitoxantrone with a predicted lower toxicity and biochemical modulation of 5-fluorouracil with levo-folinate are extensively studied research areas that could combine good therapeutic efficacy with the maintenance of an acceptable quality of life. 34 patients with advanced breast carcinoma were included in the study. Only 4 women had received prior chemotherapy for advanced disease. Treatment plan was: 5-fluorouracil 400 mg/m2 + l-leucovorin 100 mg/m2 days 1…
Effectiveness and safety of once-daily aminoglycosides: A meta-analysis
1996
The effectiveness and safety of once-daily versus several-times-daily aminoglycosides were studied in a meta-analysis. MEDLINE for 1988 to 1995 was searched, and additional studies were identified from review articles and references in retrieved articles. Studies selected for meta-analysis were randomized controlled clinical trials in nonneutropenic adult patients comparing the clinical effectiveness or nephrotoxicity or ototoxicity of once-daily with several-times-daily aminoglycosides. Differences between groups were expressed as odds ratios. The results were combined by the procedure of Mantel and Haenszel, and 95% confidence intervals and exact confidence intervals were computed. An odd…
Feasibility of a modified outpatient regimen of intravenous/intraperitoneal chemotherapy in optimally debulked stage III ovarian cancer patients: a G…
2011
Objectives: The objective of the study was to assess the feasibility, toxicity, and reasons for early discontinuation of a modified outpatient intraperitoneal/intravenous (IP/IV) chemotherapy regimen for the treatment of patients with optimally debulked stage III ovarian cancer. Methods: Between February 2006 and November 2008, 51 consecutive patients from Institutions of the Spanish Ovarian Cancer Group (GEICO) were treated with a modified outpatient IP chemotherapy regimen. Patients received IV paclitaxel 175 mg/m2 over 3 hours on day 1, followed by IP cisplatin 100 mg/m2 (or 75 mg/m2 according to the principal investigator9s criteria) on day 2. On day 8, patients received IP paclitaxel 6…
Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis
2020
IntroductionNatalizumab (NTZ) is one of the most effective treatment options for multiple sclerosis (MS) treatment. Our study aimed to evaluate the effectiveness of NTZ when administered according to the extended dosing strategy compared with standard 4-weekly administration in a large Italian MS population.Materials and methodsThis retrospective multicentre study included patients with relapsing-remitting MS (RR-MS) who received NTZ administrations between the 1 June 2012 and the 15 May 2018 and were followed by the ‘Italian MS Register’. All patients with MS were stratified into two groups based on NTZ administration schedule: standard interval dosing (SID) patients who received infusions…
THE OPTIMIZATION OF INTERFERON FOR MS STUDY: 375 MICROG INTERFERON BETA-1B IN SUBOPTIMAL RESPONDERS.
2008
We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFNbeta-1b) 375 microg (subcutaneously [sc] every other day [eod]) in relapsing-remitting multiple sclerosis (RRMS) patients with a suboptimal response to IFNbeta-1b 250 microg, i.e., with MRI activity or relapses. The OPTimization of Interferon for MS (OPTIMS) study was a prospective multicenter randomized phase 2 trial comprising a 6-month run-in phase (to identify suboptimal responders) and a 6-month randomized phase of open-label clinical and blinded MRI follow-up. During run-in all patients were treated with IFNbeta-1b 250 microg sc eod; during the study phase suboptimal treatment responders were randomized either …
Clinical and echographical control protocol of haemarthrosis in haemophilia patients with inhibitors: evaluation of the efficacy of recombinant facto…
2008
Summary. The intention of the ‘clinical and echographical protocol of evaluation the efficacy of recombinant activated factor VII in the haemarthrosis’ (EFFISEVEN protocol) was to provide an extensive study of the evolution of haemarthrosis, and second, of its repercussions on the degenerative process of joints. The clinical evaluation of haemarthroses and their evolution is based on a well-established methodology, although very few studies have sought to determine the correlation between pain, mobility and the objective data regarding the haemorrhage. We believe that it is necessary to unify criteria and that the EFFISEVEN protocol may contribute data that improve standards which, in turn…
A multicenter, double-blind, randomized, placebo-controlled trial of the β3-adrenoceptor agonist solabegron for overactive bladder
2012
Abstract Background β-Adrenoceptor agonists are effective in animal models of bladder dysfunction, and the human bladder primarily expresses the β3 receptor subtype. Objective To evaluate the efficacy and tolerability of the highly selective and potent β3-adrenoceptor agonist solabegron in a clinical proof-of-concept study in incontinent women with overactive bladder (OAB). Design, setting, and participants This was a randomized, double-blind trial in adult women with OAB (one or more 24-h incontinence episodes and eight or more average 24-h micturitions). Interventions Solabegron 50mg ( n =88), solabegron 125mg ( n =85), or placebo ( n =85)—all twice daily—were administered. Outcome measur…
Equivalence of the 3-month and 28-day formulations of triptorelin with regard to achievement and maintenance of medical castration in women with endo…
2003
OBJECTIVE: The present study aims at demonstrating the equivalence of the 28-day and 3-month formulations of triptorelin SR (sustained release) in terms of percentage of patients achieving castration levels of estradiol (<==50 pg/mL) 84 days after treatment initiation. DESIGN: A phase II, prospective, randomized, multicenter, open study was conducted in two parallel groups of women with endometriosis. SETTING: Academic hospitals. PATIENT(S): Seventy-two women with endometriosis. were treated with a single intramuscular injection of 3-month triptorelin SR, and 74 patients were treated with one intramuscular injection of 28-day triptorelin SR every 28 days for 3 months. INTERVENTION(S): As pa…
A 4-year study of the efficacy and tolerability of enzyme replacement therapy with agalsidase alfa in 36 women with Fabry disease
2009
Although Fabry disease is X linked and considered to affect primarily male hemizygotes, female heterozygotes may experience all the signs and symptoms of this metabolic disorder. This prospective, single-center, open-label, clinical trial was performed to evaluate the long-term response of female patients with Fabry disease to enzyme replacement therapy.Symptomatic women (average age = 47 years) enrolled in this 4-year study were treated with agalsidase alfa (Replagal, Shire HGT, Inc.) at a dose of 0.2 mg/kg, every other week for 4 years (N = 36). Clinical and biochemical assessments were conducted at 12-month intervals.The Mainz Severity Score Index, a measure of total disease burden, was …
Psychometric properties of 12-item self-administered World Health Organization disability assessment schedule 2.0 (WHODAS 2.0) among general populati…
2019
WHODAS 2.0 is a unified scale to measuring disability across diseases, countries, and cultures. The objective was to explore the available evidence on the psychometric properties of 12-item self-administered WHODAS 2.0 among a general population and people with non-acute physical causes of disability.Five databases Medline, Embase, Web of Science, Scopus, and PsycINFO were searched for papers related to the validity, reliability, responsiveness, minimal clinically important difference or minimal detectable change of 12-item self-administered WHODAS 2.0. In order to avoid missing any potentially relevant studies, the search clauses were left as generic as possible and the refining search was…