BackgroundThis paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial.MethodsWe retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by (...) REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives.ResultsAlmost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval.ConclusionsPreventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits. (shrink)

An amendment to this paper has been published and can be accessed via the original article.

An engaging argument about what experimental music can tell us about being human. -/- In Experimenting the Human, G Douglas Barrett argues that experimental music speaks to the contemporary posthuman, a condition in which science and technology decenter human agency amid the uneven temporality of postwar global capitalism. Time moves forward for some during this period, while it seems to stand still or even move backward for others. Some say we’re already posthuman, while others endure the extended consequences of never (...) having been considered fully human in the first place. Experimental music reflects on this state, Barrett contends, through its interdisciplinary involvements in postwar science, technology, and art movements. -/- Rather than pursuing the human’s beyond, experimental music addresses the social and technological conditions that support such a pursuit. Barrett locates this tendency of experimentalism throughout its historical entanglements with cybernetics, and in his intimate analysis of Alvin Lucier’s neurofeedback music, Pamela Z’s BodySynth performances, Nam June Paik’s musical robotics, Pauline Oliveros’s experiments with radio astronomy, and work by Laetitia Sonami, Yasunao Tone, and Jerry Hunt. Through a unique meeting of music studies, media theory, and art history, Experimenting the Human provides fresh insights into what it means to be human. (shrink)

Relatively congruence regular quasivarieties and quasivarieties of logic have noticeable similarities. The paper provides a unifying framework for them which extends the Blok-Pigozzi theory of elementarily algebraizable (and protoalgebraic) deductive systems. In this extension there are two parameters: a set of terms and a variable. When the former is empty or consists of theorems, the Blok-Pigozzi theory is recovered, and the variable is redundant. On the other hand, a class of membership logics is obtained when the variable is the only (...) element of the set of terms. For these systems the appropriate variant of equivalent algebraic semantics encompasses the relatively congruence regular quasivarieties. (shrink)

Kant’s critique/doctrine distinction tracks the difference between a canon for the understanding’s proper use and an organon for its dialectical misuse. The latter reflects the dogmatic use of reason to attain a doctrine of knowledge with no antecedent critique. In the 1790s, Fichte collapses Kant’s distinction and redefines dogmatism. He argues that deriving a canon is essentially dialectical and thus yields an organon: critical idealism is properly a doctrine of science or Wissenschaftslehre. Criticism is furthermore said to refute dogmatism, by (...) which Fichte means Spinozism. Schelling repudiates Fichte’s position in his Philosophical Letters by reviving Kant’s distinction. First, ‘critique’ for Schelling names a canon that is valid for all systems—including Spinozism—and thus favours none—not even the Wissenschaftslehre. Second, Schelling coins ‘dogmaticism’ to refer to what Kant calls ‘dogmatism’: reason’s uncritical claim to doctrine. Hence, he says all systems—even Fichte’s—are susceptible to the ‘enthusiasm’ of mistaking themselves for doctrines or ‘objects of knowledge’, instead of subjectively valid ‘objects of freedom’. I reconstruct Schelling’s argument for reviving Kant’s distinction, while noting two consequences for German idealism. First, if criticism favours no system, a system’s origin cannot be an act of knowledge, e.g., intellectual intuition, but only an act of endorsement. Second, if dogmaticism entails enthusiasm, a system’s goal cannot be absolute knowledge, but only infinite striving. Hence, by retrieving Schelling’s notion of dogmaticism, we can both gain a better understanding of the Letters and register the impact of a core Kantian distinction on the German idealist project. (shrink)

The Topos of Music is the upgraded and vastly deepened English extension of the seminal German Geometrie der Töne. It reflects the dramatic progress of mathematical music theory and its operationalization by information technology since the publication of Geometrie der Töne in 1990. The conceptual basis has been vastly generalized to topos-theoretic foundations, including a corresponding thoroughly geometric musical logic. The theoretical models and results now include topologies for rhythm, melody, and harmony, as well as a classification theory of musical (...) objects that comprises the topos-theoretic concept framework. Classification also implies techniques of algebraic moduli theory. The classical models of modulation and counterpoint have been extended to exotic scales and counterpoint interval dichotomies. The probably most exciting new field of research deals with musical performance and its implementation on advanced object-oriented software environments. This subject not only uses extensively the existing mathematical music theory, it also opens the language to differential equations and tools of differential geometry, such as Lie derivatives. Mathematical performance theory is the key to inverse performance theory, an advanced new research field which deals with the calculation of varieties of parameters which give rise to a determined performance. This field uses techniques of algebraic geometry and statistics, approaches which have already produced significant results in the understanding of highest-ranked human performances. The book's formal language and models are currently being used by leading researchers in Europe and Northern America and have become a foundation of music software design. This is also testified by the book's nineteen collaborators and the included CD-ROM containing software and music examples. (shrink)

This paper argues against the thesis of Professor Savan, that Spinoza's views about words and about the imagination are such that he could not consistently say, and indeed did not think, that philosophical truths can be expressed adequately in language. The evidence for this thesis is examined in detail, and it is argued that Spinoza should have distinguished between two types of imagination, corresponding roughly to Kant's transcendental and empirical imagination. Finally, it is suggested that the bulk of the argument (...) of the Ethics is conducted on the level of the ?second kind of knowledge?, reason, but that it also contains examples of the use of the first and third kinds of knowledge. (shrink)

Let ZF denote Zermelo-Fraenkel set theory (without the axiom of choice), and let $M$ be a countable transitive model of ZF. The method of forcing extends $M$ to another model $M\lbrack G\rbrack$ of ZF (a "generic extension"). If the axiom of choice holds in $M$ it also holds in $M\lbrack G\rbrack$, that is, the axiom of choice is preserved by generic extensions. We show that this is not true for many weak forms of the axiom of choice, and we derive (...) an application to Boolean toposes. (shrink)

We propose partial measurements as a conceptual tool to understand how to operate with counterfactual claims in quantum physics. Indeed, unlike standard von Neumann measurements, partial measurements can be reversed probabilistically. We first analyze the consequences of this rather unusual feature for the principle of superposition, for the complementarity principle, and for the issue of hidden variables. Then we move on to exploring non-local contexts, by reformulating the EPR paradox, the quantum teleportation experiment, and the entanglement-swapping protocol for the situation (...) in which one uses partial measurements followed by their stochastic reversal. This leads to a number of counter-intuitive results, which are shown to be resolved if we give up the idea of attributing reality to the wavefunction of a single quantum system. (shrink)

We show that local realism applied to states characterized by a single quantum equally and coherently shared between a number of qubits (so-called W states) produces predictions incompatible with quantum theory. The origin of this incompatibility is shown to originate from the destructive interference of amplitude probabilities associated with nonlocal states, a phenomenon that has no classical analog.

There are some who would question the need to republish papers that have already appeared elsewhere. Walter Pauel once said that scholars should think in terms of books rather than research papers since the latter become lost in the literature. When he told me this year ago I was not entirely convinced. Surely the young scholar must publish papers to secure his academic position. In addition, throughout his career he attends conferences many of which will require the publication of his (...) papers in the resultant conference volumes. By their very nature such papers often discuss topics in greater detail than that scholar's subsequent books. In this case also the papers tend to become "lost" even when there exit extensive guides to the literature such as the Critical Bibliography published annually in Isis for historians of science. Many of my own papers over the past forty-five years have indeed appeared in such conference volumes as in journals. (shrink)