Search results for "combinations"
showing 10 items of 204 documents
Evolution of HCV patient characteristics and DAA regimens in the German Hepatitis C Registry (DHC-R) in 2014 and 2015
2019
The urgent need in HCV-infected patients with liver disease mandated the rapid implementation of IFN-free DAA combination therapies following their regulatory approval in 2014 and 2015 without full knowledge of the optimal combinations and regimens. Investigating the evolution of the DAA utilization patterns and treatment outcomes could provide learnings for future situations. This was an analysis of a prospective observational database from the German Hepatitis C Registry (DHC-R) covering a period from May 2014 to September 2015. Adult patients had evidence of chronic HCV GT1 or GT4 infection and were treated with an IFN-free combination regimen of simeprevir (SMV) + sofosbuvir (SOF) or o…
Phase I dose-escalation of trifluridine/tipiracil in combination with oxaliplatin in patients with metastatic colorectal cancer
2019
Abstract Background and objectives Pre-clinical data have shown that combining trifluridine/tipiracil with oxaliplatin enhances anti-tumour activity compared with either monotherapy. A phase I dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended dose (RD) for phase II and pharmacokinetic profile of this combination in patients with metastatic colorectal cancer (mCRC) who had progressed after at least 1 prior line of treatment. Methods Using a 3 + 3 design, patients received escalating trifluridine/tipiracil doses from 25, then 30 and to 35 mg/m2 twice daily, days 1–5, q14 days, together with a fixed dose of 85 mg/m2 of oxaliplatin day 1, q14 days. A…
A Phase I dose-escalation study of third-line regorafenib with trifluridine/tipiracil in metastatic colorectal cancer
2021
Aim: To determine a recommended Phase II dose of the oral fluoropyrimidine trifluridine/tipiracil (FTD/TPI) combined with the multi-kinase inhibitor regorafenib (REG) in refractory metastatic colorectal cancer patients. Materials & methods: A conventional 3 + 3 dose finding design was used. FTD/TPI was administered on days 1–5 and 8–12 of a 28-day cycle, REG on days 2–22. Two dose levels were used: FTD/TPI 25 mg/m2 b.i.d. + REG 120 mg/d, then escalated to FTD/TPI 35 mg/m2 b.i.d. + REG 120 mg/d. Results: In total, 12 patients were treated at two dose levels. Three dose-limiting toxicities were observed; all were grade 3 hypertension causally attributed to REG. Recommended Phase II dose …
The effect of adjustable dosing with budesonide/formoterol on health-related quality of life and asthma control compared with fixed dosing
2004
Budesonide/formoterol in a single inhaler is an effective therapy for asthma. We investigated whether adjustable maintenance dosing with budesonide/formoterol could maintain health-related quality of life (HRQL) and asthma control.Asthma patients (n = 4025) received budesonide/formoterol (Symbicort 160/4.5 microg) 2 inhalations twice daily (b.i.d.) for 4 weeks during run-in of this open, multicentre study. Patients were randomised to adjustable dosing (budesonide/formoterol 1 inhalation b.i.d.; stepping up to 2 or 4 inhalations bid for 1 week if asthma worsened) or fixed dosing (budesonide/formoterol 2 inhalations b.i.d.), for 12 weeks. Change in HRQL (standardised Asthma Quality of Life Qu…
Effects of extra-fine inhaled beclomethasone/formoterol on both large and small airways in asthma
2010
BACKGROUND: Airway inflammation in asthma involves both large and small airways, and the combination of inhaled corticosteroids (ICS) and long acting beta-2 agonists (LABA) is the mainstay of therapy. Available inhaled combinations differ in terms of drug delivery to the lung and the ability to reach small airways. Aim: To evaluate whether treatment with an extra-fine inhaled combination provides additional effects vs a nonextra-fine combination on airway function. METHODS: After a 1- to 4-week run-in period, patients with asthma were randomized to a double blind, double dummy, 12-week treatment with either extra-fine beclomethasone/formoterol (BDP/F) 400/24 microg daily or fluticasone prop…
Healon5 versus Viscoat during cataract surgery: intraocular pressure, laser flare and corneal changes
2000
Background: The use of a viscoelastic substance facilitates cataract surgery. Healon 5 is a new viscoelastic product with special rheological properties. We evaluated the postoperative effect of Viscoat and Healon5 on intraocular pressure (IOP), central corneal thickness (CCT), endothelial cell counts and laser flare. Methods: Forty-eight eyes of 48 patients undergoing routine phacoemulsification followed by foldable IOL implantation were enrolled. Either Healon5 or Viscoat was used according to a block- randomization scheme. The aspiration technique was standardized. IOP, CCT, endothelial cell counts and laser flare were compared pre- and postoperatively. Statistical analysis was performed…
Comparison of the effect of low level laser therapy with alvogyl on the management of alveolar osteitis
2014
Background This study investigated the efficacy of low level laser therapy (LLLT) for managing alveolar osteitis (AO). Material and Methods Sixty patients with alveolar osteitis of mandibular third molars were randomly divided into three groups. In group 1, socket irrigation was followed by alvogyl placement, and the treatment was repeated 48 hours later. In group 2, socket was irradiated with a low power red laser for 3 consecutive days (200 mW, 30 seconds on each of the buccal and lingual surfaces and 30 seconds at the middle of the socket, 6 J per area). The subjects in group 3 underwent treatment with a low power infrared laser with the same parameters as group 2. A visual analogue scal…
Cytological changes in the oral mucosa after use of a mouth rinse with alcohol. A prospective double blind control study
2012
Aim: The aim of this preliminary study was to detect cytological changes in the oral mucosa after using a mouth wash with alcohol. Material and Methods: A prospective double-blind, controlled study was performed, for 6 months. Group 1 consisted of 30 subjects who used a mouth rinse with 26.9% of alcohol [Listerine®] and Group 2 consisted of 30 subjects who used a mouth rinse with the same ingredients but with no alcohol. We obtained three cytological samples from the oral mucosa. The presence of cytological atypia, binucleation and karyorrhesis, and type of cells were studied. We also used a fluorescent in situ hybridization technique (FISH) in 15 samples in each group, for the micronucleus…
The effects of an amine fluoride/stannous fluoride and an antimicrobial host protein mouthrinse on supragingival plaque regrowth.
2004
BACKGROUND: Chlorhexidine (CHX)-containing mouthrinses are recommended as adjuncts to mechanical oral hygiene. The problem associated with side effects, however, has stimulated the search for alternative antiplaque agents. The aim of this study was to investigate the plaque inhibitory effects of two mouthrinses containing amine fluoride/stannous fluoride (ASF) and antimicrobial host proteins (lactoperoxidase, lysozyme and lactoferrin; LLL), respectively. METHODS: The study was an observer-masked, randomized 4x4 Latin square cross-over design balanced for carryover effects, involving 12 healthy volunteers in a 4-day plaque regrowth model. A 0.12% CHX mouthrinse and a saline solution served a…
Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: The BRIGHT study
2014
Summary Introduction QVA149 is a novel, inhaled, once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β 2 -agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237), for the treatment of chronic obstructive pulmonary disease (COPD). This study evaluated the effects of QVA149 on exercise tolerance, hyperinflation, lung function and lung volumes versus placebo and tiotropium. Methods Patients with moderate-to-severe COPD were randomized to QVA149 110/50 μg, placebo or tiotropium 18 μg once daily in a blinded, 3-period crossover study for 3 weeks. The primary endpoint was exercise endurance time at Day 21 for QVA149 versus placebo. R…