Search results for "clinical research"

A randomized phase II study of pemetrexed in combination with cisplatin or carboplatin as first-line therapy for patients with locally advanced or me…

2013

Abstract Background Pemetrexed plus cisplatin was approved for first-line treatment of non–small-cell lung cancer (NSCLC) in patients with nonsquamous histology after initiation of this study. This phase II study evaluated pemetrexed plus cisplatin and pemetrexed plus carboplatin as first-line treatments for stage IIIB/IV NSCLC. Patients and Methods The patients were randomized (1:1) to 2 parallel arms: pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or pemetrexed (500 mg/m2) plus carboplatin (area under the curve 6) day 1 every 3 weeks (maximum, 6 cycles). Progression-free survival (PFS) was the primary objective; secondary objectives included overall survival (OS), 1-year survival, and s…

Oral temozolomide in heavily pre-treated brain metastases from non-small cell lung cancer: phase II study

2005

Introduction: The primary tumour type most likely to metastasize to the brain is lung cancer. In heavily pre-treated patients, limited therapeutic option is available and the results of availability therapies reported in literature are disappointing. The present phase II study was designed to assess the efficacy and safety of temozolomide (TMZ) as palliative treatment for brain metastases (BrM) in NSCLC patients pre-treated with WBRT and at least one line of chemotherapy for metastatic brain disease. Material and methods: Temozolomide was administered orally at 150 mg/mq/day for five consecutive days for the first cycle, doses were increased to 200 mg/mq/day for 5 days every 28 days for sub…

C1-02: Randomized Phase II study of vandetanib alone or in combination with carboplatin and paclitaxel as 1st-line treatment for advanced NSCLC

2007

Alternative mechanisms for tiotropium

2009

Tiotropium is commonly used in the treatment of chronic obstructive pulmonary disease. Although largely considered to be a long-acting bronchodilator, its demonstrated efficacy in reducing the frequency of exacerbations and preliminary evidence from early studies indicating that it might slow the rate of decline in lung function suggested mechanisms of action in addition to simple bronchodilation. This hypothesis was examined in the recently published UPLIFT study and, although spirometric and other clinical benefits of tiotropium treatment extended to four years, the rate of decline in lung function did not appear to be reduced by the addition of tiotropium in this study. This article summ…

Protocol for the EARCO Registry

2020

Rationale and objectives Alpha-1 antitrypsin deficiency (AATD) is a genetic condition that leads to an increased risk of emphysema and liver disease. Despite extensive investigation, there remain unanswered questions concerning the natural history, pathophysiology, genetics and the prognosis of the lung disease in association with AATD. The European Alpha-1 Clinical Research Collaboration (EARCO) is designed to bring together researchers from European countries and to create a standardised database for the follow-up of patients with AATD. Study design and population The EARCO Registry is a non-interventional, multicentre, pan-European, longitudinal observational cohort study enrolling patie…

Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement

2015

Background Exacerbations are a key outcome in clinical research, providing patient-relevant information about symptomatic control, health state and disease progression. Generally considered as an episode of (sub)acute deterioration of respiratory symptoms, a precise, clinically useful definition is needed for use in clinical trials. Aim and methods Focussing on moderate exacerbations, this opinion piece reviews landmark trials and current guidelines to provide a practical definition of a moderate exacerbation. Specifically, we adapt the ATS/ERS consensus statement of terminology Reddel et al. (2009) [1] which provides a conceptual (or 'theoretical') definition for moderate exacerbations, to…

Cost-Effectiveness Analysis of Different Testing Strategies that Use Antibody Levels to Detect Chronic Hepatitis C in Blood Donors.

2016

Aim. We conducted a cost-effectiveness analysis of seven hepatitis C virus (HCV) testing strategies in blood donors. Methods. Three of the seven strategies were based on HCV diagnosis and reporting guidelines in Mexico and four were from previous and current recommendations outlined by the CDC. The strategies that were evaluated determine antibody levels according to the signal-to-cut-off (S/CO) ratio and use reflex Immunoblot (IMB) or HCV RNA tests to confirm true positive (TP) cases of chronic HCV infection. Costs were calculated from the perspective of the Mexican Institute of Social Security (IMSS). A decision tree model was developed to estimate the expected number of true positive cas…

An Open-Label Trial of 12-Week Simeprevir plus Peginterferon/Ribavirin (PR) in Treatment-Naïve Patients with Hepatitis C Virus (HCV) Genotype 1 (GT1)

2016

Background: Shortening duration of peginterferon-based HCV treatment reduces associated burden for patients. Primary objectives of this study were to assess the efficacy against the minimally acceptable response rate 12 weeks post-treatment (SVR12) and safety of simeprevir plus PR in treatment-naïve HCV GT1 patients treated for 12 weeks. Additional objectives included the investigation of potential associations of rapid viral response and baseline factors with SVR12. Methods: In this Phase III, open-label study in treatment-naïve HCV GT1 patients with F0-F2 fibrosis, patients with HCV-RNA 12-week regimen. Conclusions: Overall SVR12 rate (66%) was below the target of 80%, indicating that sho…

Translation, Adaption, and Psychometric Testing of the Myanmar Version of the Medical Outcomes Study Social Support Survey for People Living With HIV…

2021

Introduction: Valid and reliable instruments are crucial for measuring perceived social support among people living with HIV (PLHIV). We aimed to investigate the psychometric properties of the English version of the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) adapted for PLHIV in Myanmar.Methods: Based on a standard cross-cultural procedure, we adapted the MOS-SSS and formed a Myanmar version of the scale (MOS-SSS-M), and then tested its validity and reliability. A sample of 250 eligible PLHIV was collected from a closed Facebook group that included more than 10,000 Myanmars, most of whom were PLHIV.Results: The MOS-SSS-M achieved a Cronbach’s α of 0.82–0.95. Confirmatory…

Trifocal toric intraocular lenses in eyes with low amount of corneal astigmatism.

2020

Aim To evaluate the refractive and visual outcomes following cataract surgery and implantation of a trifocal toric intraocular lens (IOL) in eyes with low degrees of corneal astigmatism. Methods Twenty-six eyes of 22 patients who underwent implantation a trifocal toric IOL (FineVision PODFT, PhysIOL s.a., Liege, Belgium) were enrolled. Phacoemulsification with femtosecond laser, capsular tension ring insertion and intraoperative aberrometry were performed in all cases. All IOLs used showed a cylinder power of 1.00 D. Main outcome measures were refractive error and corrected-distance visual acuity (CDVA) and uncorrected-distance visual acuity (UDVA) values. Eyes were evaluated at 4mo post-su…