Search results for "Clinical Study"
showing 10 items of 211 documents
Surveillance of spontaneous breast cancer metastasis by TRAIL-expressing CD34⁺ cells in a xenograft model
2012
Tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), delivered as a membrane-bound molecule expressed on the surface of adenovirus-transduced CD34+ cells (CD34-TRAIL+), was analyzed for its apoptotic activity in vitro on 12 breast cancer cell lines representing estrogen receptor-positive, HER2+ and triple-negative (TN) subtypes and for its effect on tumor growth, vascularization, necrosis, and lung metastasis incidence in NOD/SCID mice xenografted with the TN breast cancer line MDA-MB-231. Mesenchymal TN cell lines, which are the richest in putative tumor stem cells among the different breast cancer cell subtypes, were the most susceptible to apoptosis induced by CD34-TRAIL+ cel…
Validity of needle core biopsy in the histological characterisation of mammary lesions
2006
Summary Over the last few years, there has been an enormous increase in the use of needle core biopsy (CB) for the histopathological characterisation of suspect lesions of the breast. The aim of this study was to verify the diagnostic reliability of CB by comparing the histological results obtained with the use of this technique with those obtained from the whole of the surgically resected specimen. We studied 198 out of 426 patients with clinically and/or radiologically suspect breast lesions. We found correspondence between the histological examination of the whole of the excised specimen and that of the CB in 94.9% of the cases of infiltrating carcinoma and in 71.4% of those involving du…
A human factors intervention in a hospital - evaluating the outcome of a TeamSTEPPS program in a surgical ward
2021
AbstractBackgroundPatient safety in hospitals is being jeopardized, since too many patients experience adverse events. Most of these adverse events arise from human factors, such as inefficient teamwork and communication failures, and the incidence of adverse events is greatest in the surgical area. Previous research has shown the effect of team training on patient safety culture and on different areas of teamwork. Limited research has investigated teamwork in surgical wards. The aim of this study was to evaluate the professional and organizational outcomes of a team training intervention among healthcare professionals in a surgical ward after 6 and 12 months. Systems Engineering Initiative…
Determinants of self-reported smoking and misclassification during pregnancy, and analysis of optimal cut-off points for urinary cotinine: a cross-se…
2013
10 p. Objectives: To estimate the prevalence and factors associated with smoking and misclassification in pregnant women from INMA (INfancia y Medio Ambiente, Environment and Childhood) project, Spain, and to assess the optimal cut-offs for urinary cotinine (UC) that best distinguish daily and occasional smokers with varying levels of second-hand smoke (SHS) exposure.-- Design: We used logistic regression models to study the relationship between sociodemographic variables and self-reported smoking and misclassification (self-reported non-smokers with UC >50 ng/ml). Receiver operating characteristic (ROC) curves were used to calculate the optimal cut-off point for discriminating smokers. The…
How Effective and Safe Is Bronchial Thermoplasty in “Real Life” Asthmatics Compared to Those Enrolled in Randomized Clinical Trials?
2016
There is limited information on the efficacy and safety of bronchial thermoplasty (BT) inreal life. We evaluated the outcomes of the randomized clinical trials for BT in severe asthmatics, in whom the exclusion criteria were not strictly controlled. A case series of seven asthmatics (M/F: 4/3; age:54.6±2.9years) is reported. Subjects had a statistically significant improvement in AQLQ (from a mean of3.96±1.1to4.5±1.2and5.5±0.6after 6 and 12 months of treatment;p=0.0007) and in the ACQ score (from2.77±0.8to1.83±1.2and1.5±0.8after 6 and 12 months;p<0.001). In the year after BT, severe exacerbations, salbutamol use, and OCS use were significantly lower compared with the 1-yr pretreatment pe…
Effect of a single initial phase of non-surgical treatment of peri-implantitis: Abrasive air polishing versus ultrasounds. A prospective randomized c…
2020
Background Non-surgical treatment of peri-implantitis includes a correct mechanical debridement of the implant surface to reduce the inflammation and recondition the soft tissues. The aim of the study was to evaluate the results of a single phase of non-surgical therapy by comparing the effect of curettes and ultrasounds versus curettes and abrasive air polisher (Air-Flow) in the peri-implant tissue conditions, and patient satisfaction. Material and Methods A double-blind randomized and controlled prospective clinical study was conducted on patients in peri-implant maintenance phase diagnosed of peri-implantitis treated in the Oral Surgery Unit of the Stomatology Department of the Faculty o…
Strategies for Including Patients Recruited During Interim Analysis of Clinical Trials
2007
In clinical trials a periodical check of safety and efficacy data is often needed. For organizational reasons it is rarely desirable to stop a trial during such an interim analysis. Therefore, new study patients are included in the trial while the interim analysis is ongoing. Disregarding the additional information provided by these interim patients would be unsatisfactory, especially for an office of regulatory affairs. Consequently, the rules for group sequential or adaptive decisions must be adjusted to the recruitment of interim patients. In this paper, two strategies for modifying study designs to consider the analysis of interim patients are proposed.
IMI – Oral biopharmaceutics tools project – Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and ov…
2016
Orally administered drugs are subject to a number of barriers impacting bioavailability (Foral), causing challenges during drug and formulation development. Physiologically-based pharmacokinetic (PBPK) modelling can help during drug and formulation development by providing quantitative predictions through a systems approach. The performance of three available PBPK software packages (GI-Sim, Simcyp®, and GastroPlus™) were evaluated by comparing simulated and observed pharmacokinetic (PK) parameters.Since the availability of input parameters was heterogeneous and highly variable, caution is required when interpreting the results of this exercise. Additionally, this prospective simulation exer…
Carga y factores de riesgo para la neumonía adquirida en la comunidad de Pseudomonas aeruginosa : un estudio multinacional de prevalencia puntual de …
2018
Pseudomonas aeruginosa is a challenging bacterium to treat due to its intrinsic resistance to the antibiotics used most frequently in patients with community-acquired pneumonia (CAP). Data about the global burden and risk factors associated with P. aeruginosa-CAP are limited. We assessed the multinational burden and specific risk factors associated with P. aeruginosa-CAP. We enrolled 3193 patients in 54 countries with confirmed diagnosis of CAP who underwent microbiological testing at admission. Prevalence was calculated according to the identification of P. aeruginosa. Logistic regression analysis was used to identify risk factors for antibiotic-susceptible and antibiotic-resistant P. aeru…
Cost-effectiveness of psychotropic polypharmacy in routine schizophrenia care. Results of the ELAN prospective observational trial
2018
Abstract Aims To analyse the costs and cost-effectiveness of psychotropic polypharmacy in comparison to antipsychotic monotherapy in patients with schizophrenia and schizo-affective disorder under real-world treatment conditions. Methods A prospective observational study including 374 adult psychiatric in-patients with schizophrenia or schizo-affective disorder was conducted. Psychotropic regimen, clinical outcomes, and quality of life were assessed before discharge and after 6, 12, 18, and 24 months. Costs and outcomes of psychotropic polypharmacy in comparison to antipsychotic monotherapy were analysed by means of mixed-effects regression models adjusted for propensity scores. Net-benefit…