Systematic Data Monitoring and Analysis of Cardiovascular Off-label Prescriptions in Pediatrics: Focus on Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Beta Blockers

Introduction: Many efforts have been made to stimulate clinical trials (CTs) in pediatrics but most of the drugs are still authorized only in adults and used off-label in the pediatric population. Aim: To assess how widespread is the off-label prescription in Italy and to identify areas of unmet medical need by applying a model for the systematic collection and analysis of data. Methods: A study was performed using 2015 data from the Italian Medicines Utilization Monitoring Centre Health Database (OsMed). A study sample of 3,726,583 pediatric patients, was considered. Cardiovascular drugs were selected for this study. Assessment of the off-label use, the analysis of the pharmacovigilance signals, a bibliographic research and the analysis of ongoing CTs were carried out. Results: In 2015, 8,544 pediatric patients received treatment with a cardiovascular drug. Angiotensin converting enzyme inhibitors (ACE-I) followed by beta blockers agents are the most prescribed molecules. Eight molecules were selected and an in-depth analysis conducted. The PhV network showed only one record of adverse reaction as off-label in 2015. The results show several therapeutic areas of use in pediatrics. Conclusion: Off-label in pediatrics is largely widespread in Europe and US and our results show it is also present in Italy. Molecules selected are used off-label for therapeutic areas such as oncologic, hematological and rare diseases. Results of pharmacovigilance suggests underreporting. The analysis carried out in this study could be an open track for a systematic monitoring activity and of interest for prescribers, pediatricians and other healthcare professionals during the clinical practice

Mental health research projects: a practical integration of mental health into a medical curriculum

Abstract of a paper presented at the 65th Annual National Conference of Indian Psychiatric Society, Bangalor, 10-13 Jan, 2013. Aims aJld Objectives: The University of Wollongong (UoW) graduate-entry medical course embeds research and critical analysis within the curriculum, concluding with students undertaking a regional/ nlrsl conmlUnity-based ro earch project. Students are encouraged to design a research project of interest to them and the local community. T.his Indy analyzed whether conducting research projects enhanced learning/understanding about rural/regional mental health issues amongst UoW medical students

A Geant4 simulation code for simulating optical photons in SPECT scintillation detectors

Geant4 is an object oriented toolkit created for the simulation of High-Energy Physics detectors. Geant4 allows an accurate modeling of radiation sources and detector devices, with easy configuration and friendly interface and at the same time with great accuracy in the simulation of physical processes. While most Monte Carlo codes do not allow the simulation of the transport and boundary characteristics for optical photons transport generated by scintillating crystal, Geant4 allows the simulation of the optical photons. In this paper we present an application of the Geant4 program for simulating optical photons in SPECT cameras. We aim to study the light transport within scintillators, photomultiplier tubes and coupling devices. To this end, we simulated a detector based on a scintillator, coupled to a photomultiplier tube through a glass window. We compared simulated results with experimental data and theoretical models, in order to verify the good matching with our simulations. We simulated a pencil beam of 140 keV photons impinging the crystal at different locations. For each condition, we calculated the value of the Pulse Height Centroid and the spread of the charge distribution, as read out by the anode array of the photomultiplier. Finally, the spatial and the energy resolutions of the camera have been estimated by simulated data. In all cases, we found that simulations agree very well with experimental data

Generic bounds on dipolar gravitational radiation from inspiralling compact binaries

Various alternative theories of gravity predict dipolar gravitational radiation in addition to quadrupolar radiation. We show that gravitational wave (GW) observations of inspiralling compact binaries can put interesting constraints on the strengths of the dipole modes of GW polarizations. We put forward a physically motivated gravitational waveform for dipole modes, in the Fourier domain, in terms of two parameters: one which captures the relative amplitude of the dipole mode with respect to the quadrupole mode ($\alpha$) and the other a dipole term in the phase ($\beta$). We then use this two parameter representation to discuss typical bounds on their values using GW measurements. We obtain the expected bounds on the amplitude parameter $\alpha$ and the phase parameter $\beta$ for Advanced LIGO (AdvLIGO) and Einstein Telescope (ET) noise power spectral densities using Fisher information matrix. AdvLIGO and ET may at best bound $\alpha$ to an accuracy of $\sim10^{-2}$ and $\sim10^{-3}$ and $\beta$ to an accuracy of $\sim10^{-5}$ and $\sim10^{-6}$ respectively.Comment: Matches with the published versio

Nuclear Instruments and Methods in Physics Research Section A: Accelerators, Spectrometers, Detectors and Associated Equipment

GEMS (Gamma Energy Marine Spectrometer) is a prototype of an autonomous radioactivity sensor for underwater measurements, developed in the framework for a development of a submarine telescope for neutrino detection (KM3NeT Design Study Project). The spectrometer is highly sensitive to gamma rays produced by 40K decays but it can detect other natural (e.g., 238U,232Th) and anthropogenic radio-nuclides (e.g., 137Cs). GEMS was firstly tested and calibrated in the laboratory using known sources and it was successfully deployed for a long-term (6 months) monitoring at a depth of 3200 m in the Ionian Sea (Capo Passero, offshore Eastern Sicily). The instrument recorded data for the whole deployment period within the expected specifications. This monitoring provided, for the first time, a continuous time-series of radioactivity in deep-sea.In press4.5. Studi sul degassamento naturale e sui gas petroliferiJCR Journalope

Buprenorphine versus dihydrocodeine for opiate detoxification in primary care: a randomised controlled trial

Background Many drug users present to primary care requesting detoxification from illicit opiates. There are a number of detoxification agents but no recommended drug of choice. The purpose of this study is to compare buprenorphine with dihydrocodeine for detoxification from illicit opiates in primary care. Methods Open label randomised controlled trial in NHS Primary Care (General Practices), Leeds, UK. Sixty consenting adults using illicit opiates received either daily sublingual buprenorphine or daily oral dihydrocodeine. Reducing regimens for both interventions were at the discretion of prescribing doctor within a standard regimen of not more than 15 days. Primary outcome was abstinence from illicit opiates at final prescription as indicated by a urine sample. Secondary outcomes during detoxification period and at three and six months post detoxification were recorded. Results Only 23% completed the prescribed course of detoxification medication and gave a urine sample on collection of their final prescription. Risk of non-completion of detoxification was reduced if allocated buprenorphine (68% vs 88%, RR 0.58 CI 0.35–0.96, p = 0.065). A higher proportion of people allocated to buprenorphine provided a clean urine sample compared with those who received dihydrocodeine (21% vs 3%, RR 2.06 CI 1.33–3.21, p = 0.028). People allocated to buprenorphine had fewer visits to professional carers during detoxification and more were abstinent at three months (10 vs 4, RR 1.55 CI 0.96–2.52) and six months post detoxification (7 vs 3, RR 1.45 CI 0.84–2.49). Conclusion Informative randomised trials evaluating routine care within the primary care setting are possible amongst drug using populations. This small study generates unique data on commonly used treatment regimens

GEMS: Underwater spectrometer for long-term radioactivity measurements

GEMS (Gamma Energy Marine Spectrometer) is a prototype of an autonomous radioactivity sensor for underwater measurements, developed in the framework for a development of a submarine telescope for neutrino detection (KM3NeT Design Study Project). The spectrometer is highly sensitive to gamma rays produced by 40K decays but it can detect other natural (e.g., 238U,232Th) and anthropogenic radio-nuclides (e.g., 137Cs). GEMS was firstly tested and calibrated in the laboratory using known sources and it was successfully deployed for a long-term (6 months) monitoring at a depth of 3200 m in the Ionian Sea (Capo Passero, offshore Eastern Sicily). The instrument recorded data for the whole deployment period within the expected specifications. This monitoring provided, for the first time, a continuous time-series of radioactivity in deep-sea

The scientific potential of space-based gravitational wave detectors

The millihertz gravitational wave band can only be accessed with a space-based interferometer, but it is one of the richest in potential sources. Observations in this band have amazing scientific potential. The mergers between massive black holes with mass in the range 10 thousand to 10 million solar masses, which are expected to occur following the mergers of their host galaxies, produce strong millihertz gravitational radiation. Observations of these systems will trace the hierarchical assembly of structure in the Universe in a mass range that is very difficult to probe electromagnetically. Stellar mass compact objects falling into such black holes in the centres of galaxies generate detectable gravitational radiation for several years prior to the final plunge and merger with the central black hole. Measurements of these systems offer an unprecedented opportunity to probe the predictions of general relativity in the strong-field and dynamical regime. Millihertz gravitational waves are also generated by millions of ultra-compact binaries in the Milky Way, providing a new way to probe galactic stellar populations. ESA has recognised this great scientific potential by selecting The Gravitational Universe as its theme for the L3 large satellite mission, scheduled for launch in ~2034. In this article we will review the likely sources for millihertz gravitational wave detectors and describe the wide applications that observations of these sources could have for astrophysics, cosmology and fundamental physics.Comment: 18 pages, 2 figures, contribution to Gravitational Wave Astrophysics, the proceedings of the 2014 Sant Cugat Forum on Astrophysics; v2 includes one additional referenc