Clinical trials on medicinal products in Malta following EU accession

Following EU Accession, Malta has to adopt EU Directives as part of its own legislation. Three such directives concern the conduct of clinical trials in European countries ­ 2001/20/EC, 2003/94/EC and 2005/28/EC. These directives, and the respective guidelines explaining their implementation, have considerably changed the way clinical trials are conducted. While the participation of Malta in clinical trials is to be encouraged for various reasons, these have to be regulated according to the legislation set out by the European Union. In themselves, what these Directives strive to achieve are mainly the safety of the study subject and the protection of the investigators from serious consequences. This short article aims to give a brief overview of these changes to prospective investigators and hospital administrators.peer-reviewe

Para-infectious brain injury in COVID-19 persists at follow-up despite attenuated cytokine and autoantibody responses

To understand neurological complications of COVID-19 better both acutely and for recovery, we measured markers of brain injury, inflammatory mediators, and autoantibodies in 203 hospitalised participants; 111 with acute sera (1–11 days post-admission) and 92 convalescent sera (56 with COVID-19-associated neurological diagnoses). Here we show that compared to 60 uninfected controls, tTau, GFAP, NfL, and UCH-L1 are increased with COVID-19 infection at acute timepoints and NfL and GFAP are significantly higher in participants with neurological complications. Inflammatory mediators (IL-6, IL-12p40, HGF, M-CSF, CCL2, and IL-1RA) are associated with both altered consciousness and markers of brain injury. Autoantibodies are more common in COVID-19 than controls and some (including against MYL7, UCH-L1, and GRIN3B) are more frequent with altered consciousness. Additionally, convalescent participants with neurological complications show elevated GFAP and NfL, unrelated to attenuated systemic inflammatory mediators and to autoantibody responses. Overall, neurological complications of COVID-19 are associated with evidence of neuroglial injury in both acute and late disease and these correlate with dysregulated innate and adaptive immune responses acutely

Editorial [The Synapse, (3)] 

Part 2 of this editorial can be found through this link: https://www.um.edu.mt/library/oar//handle/123456789/13100Editorial regarding additive manufacturing (including stereolithography), that is 3D printing and its medical use in surgery.peer-reviewe

Avatar clinicians? : try the jazz for christmas

Jazz is defined as a genre of music which originated during the late 19th and early 20th century. However in our case, the term Jazz is referring to a remote presence system for doctors, developed by the French company Gostai. In essence it may also be called an avatar system. Jazz consists of a 3 foot robot possessing an articulated head mounted with an LCD screen, a docking station (for charging), as well as an Urbi open-source cross-platform software platform in C++.peer-reviewe

Characteristics of 15 high-risk breast cancer families selected for exome sequencing.

a<p>Breast cancer (BC), ovarian cancer (OC), bilat. (bilateral). Age of diagnosis shown in parentheses.</p>b<p>Other cancer types observed in family branch with apparent breast cancer risk (multiple cases shown in parentheses).</p

<i>FANCC</i> and <i>BLM</i> mutations identified in familial breast cancer pedigrees.

<p>Males and females are represented by squares and circles, respectively. Arrows indicate individuals who underwent whole exome sequencing (families 1–3) or were the index case in subsequent mutation analysis (<i>FANCC</i> p.Asp23fs, p.Leu554Pro and p.Arg185Gln and <i>BLM</i> p.Arg899* families). Cancer-affected individuals are represented with the following symbols: breast cancer, top right quadrant filled in; bilateral breast cancer, top half; ovarian cancer, bottom left quadrant; or other cancers as indicated, centre circle. Mutation status is indicated with either the family specific mutation or wildtype (wt) under each tested individual. Age at cancer diagnosis or year of birth (b.) where known is shown for all mutation carriers. Breast cancer (BC), ovarian cancer (OC), acute leukaemia (AL), colorectal cancer (CRC), haematological malignancy (type unspecified) (Haem.), kidney cancer (KC), liver cancer (LivC), melanoma (Mel.), pancreatic cancer (PaC), prostate cancer (PrC), skin non-melanoma (Non-mel.) stomach cancer (SC), testicular cancer (TestC). Mutations indicated in parentheses indicate untested obligate carriers. Family 2 contains an individual (indicated by #) for whom mutation status is inferred assuming that non-paternity or gonadal mosaicism have not occurred.</p

Imperfections in the Economics of Public Policy, Imperfections in Markets, and Climate Change

In the last twenty years economics has created much of lasting value and real potential: it has been a very fertile period. But economics has also suffered from what I shall term collective amnesia covering whole areas of public policy. And on policy and the role of government it has, embarrassingly in my view, swayed with the political winds to the detriment of both our profession and to outcomes. Both the amnesia and the political bending have contributed to the economic crisis of the last year or two and to hostility towards the profession. My purpose here is first to lament the amnesia on theories of public policy in imperfect economies, in short the subject of public economics, to describe the bending of public policy analysis to political vogue, and to indicate some of the consequences. I then describe some of the mechanics of the processes described, in terms of choice of models and patterns of teaching. Finally, I use the example of climate change to illustrate some of the consequences of the amnesia, as well as of the political influence