Search results for "Data monitoring"
showing 7 items of 7 documents
Ropeginterferon alfa-2b versus phlebotomy in low-risk patients with polycythaemia vera (Low-PV study): a multicentre, randomised phase 2 trial.
2021
Summary Background There is no evidence that phlebotomy alone is sufficient to steadily maintain haematocrit on target level in low-risk patients with polycythaemia vera. This study aimed to compare the efficacy and safety of ropeginterferon alfa-2b on top of the standard phlebotomy regimen with phlebotomy alone. Methods In 2017, we launched the Low-PV study, a multicentre, open-label, two-arm, parallel-group, investigator-initiated, phase 2 randomised trial with a group-sequential adaptive design. The study involved 21 haematological centres across Italy. Participants were recruited in a consecutive order. Participants enrolled in the study were patients, aged 18–60 years, with a diagnosis…
Improved inter-observer agreement of an expert review panel in an oncology treatment trial--Insights from a structured interventional process.
2015
Abstract Purpose Oncologic imaging is a key for successful cancer treatment. While the quality assurance (QA) of image acquisition protocols has already been focussed, QA of reading and reporting offers still room for improvement. The latter was addressed in the context of a prospective multicentre trial on fluoro-deoxyglucose (FDG)–positron-emission tomography (PET)/CT-based chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC). Material and methods An expert panel was prospectively installed performing blinded reviews of mediastinal NSCLC involvement in FDG–PET/CT. Due to a high initial reporting inter-observer disagreement, the independent data monitoring committee (I…
Development of a big data bank for PV monitoring data, analysis and simulation in COST Action 'PEARL PV'
2019
COST Action entitled PEARL PV aims at analyzing data of monitored PV systems installed all over Europe to quantitatively evaluate the long-term performance and reliability of these PV systems. For this purpose, a data bank is being implemented that can contain vast amounts of data, which will enable systematic performance analyses in combination with simulations. This paper presents the development process of this data bank.
Phase 3 randomized study of adjuvant anastrozole (A), exemestane (E), or letrozole (L) with or without tamoxifen (T) in postmenopausal women with hor…
2017
515 Background: Uncertainty still exists regarding the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors (AI) and no trial has ever compared all the three AI. Methods: FATA-GIM3 is a multicenter, open label, 2x3 factorial phase 3 randomized study of adjuvant A, E and L upfront (UP - for 5 years) or sequentially (SEQ - for 3 years after 2 years of T) in postmenopausal HR breast cancer pts. Two comparisons were planned: UP vs SEQ and A vs E vs L. DFS (including local or distant relapse, second breast or non-breast cancer, DCIS and death, whichever came first) was the primary end-point; 2% at 5 yrs (corresponding to a HR of 0.79) was defined as the minimum diff…
Validity and reliability of an inertial sensor device for specific running patterns in soccer
2021
Electronic performance tracking devices are largely employed in team sports to monitor performance and improve training. To date, global positioning system (GPS) based devices are those mainly used in soccer training. The aim of this study was to analyse the validity and reliability of the inertial sensor device (ISD) in monitoring distance and speed in a soccer-specific circuit and how their performance compare to a GPS system. 44 young male soccer players (age: 14.9 ± 1.1, range 9–16, years, height: 1.65 ± 0.10 m, body mass: 56.3 ± 8.9 kg) playing in a non-professional soccer team in Italy, participated in the study. We assessed the players trough a soccer running sport-specific circuit. …
Dexamethasone treatment for the acute respiratory distress syndrome: a multicentre, randomised controlled trial
2020
Background There is no proven specific pharmacological treatment for patients with the acute respiratory distress syndrome (ARDS). The efficacy of corticosteroids in ARDS remains controversial. We aimed to assess the effects of dexamethasone in ARDS, which might change pulmonary and systemic inflammation and result in a decrease in duration of mechanical ventilation and mortality. Methods We did a multicentre, randomised controlled trial in a network of 17 intensive care units (ICUs) in teaching hospitals across Spain in patients with established moderate-to-severe ARDS (defined by a ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen of 200 mm Hg or less assesse…
Pandemetrics: systematically assessing, monitoring, and controlling the evolution of a pandemic
2022
AbstractThe still ongoing pandemic of SARS-CoV-2 virus and COVID-19 disease, affecting the population worldwide, has demonstrated the need of more accurate methodologies for assessing, monitoring, and controlling an outbreak of such devastating proportions. Authoritative attempts have been made in traditional fields of medicine (epidemiology, virology, infectiology) to address these shortcomings, mainly by relying on mathematical and statistical modeling. However, here, we propose approaching the methodological work from a different, and to some extent alternative, standpoint. Applied systematically, the concepts and tools of statistical engineering and quality management, developed not onl…