Background In modern Russia, any clinical investigation of a pharmaceutical for use in humans is subject to prior evaluation and approval by the Ministry of Health and its Central Ethics Committee. Despite this, some researchers and trial sponsors fail to comply, this is particularly true in case of the studies initiated by domestic sponsors or sponsor-investigators and published in Russian language medical journals. This exploratory research aims to discover whether it is a sporadic non-compliance with regulations or a common practice. (...) Methods We searched the Russian language database eLIBRARY for the phrase ‘results of a randomised trial’. We selected publications reporting clinical trials and conducted in Russia. For each of the selected studies, we searched the state register of the approved clinical trials. We assessed whether the investigational medicinal product was approved for marketing in Russia; the therapeutic indications, posology, and administration method in the clinical trial were consistent with the approved labelling; the issue of the journal included an advertisement of the medicinal product in question; and the full description of the methodology corroborated that the clinical trial was randomised, as was stated in the title or abstract. Results Of the 26 selected articles, 22 reported the results of unauthorised clinical trials. Three of those trials were conducted in children. Twenty-one studies reported on data from unauthorised trials for investigational products approved for marketing in Russia. However, in nine cases, the therapeutic indications, posology, or administration method did not match the conditions indicated in the labelling. Moreover, in one case, the unauthorised trial included a drug therapy intervention where the active substance was not approved for use in any medicinal product marketed in Russia. In 14 of the 26 articles, the issue of the journal or the article itself contained an advertisement for the same medicinal product or, in one case, its manufacturer. All publications accompanied by advertisements claimed that the medicinal product in question was efficacious. Conclusions A substantial fraction of the clinical trials initiated by domestic sponsors and reported in Russian medical journals failed to obtain the mandatory prior evaluation and approval from the regulator. This can affect the rights and well-being of the study participants and the scientific validity of the studies. (shrink)

In applying statutory safeguards, the FDA must not regulate investigational new products so stringently that a life‐saving therapy is unavailable. But the agency must also protect dying patients from exploitation by unscrupulous or overzealous researchers. The balance between individual choice and public protection has been questioned in cases involving experimental AIDS drugs and an artificial heart.

Advanced new therapies, such as stem cell and gene therapies and xenotransplantation, represent challenges for regulatory and ethical review. Major drug agencies, such as in the U.S., India, and Europe, have asserted regulatory authority and require ethics review by local ethics review committees, using the same strict requirements as those for standard drug approvals. In spite of this, unapproved and undocumented stem cell clinics flourish in all of these places, suggesting that current approaches do not offer patients sufficient protection. (...) Japan has attempted another approach, requiring approvals at local levels for all regenerative medical procedures, and a faster approval of promising new interventions. The Japanese approach has, however, also been criticized as not striking a proper balance between early access and a proper assessment of safety and effectiveness. For smaller and less-resourced countries, such as Thailand, one major challenge is limited expertise to conduct the evaluation of these advanced new therapies. This article provides an overview of the issues facing regulators and proposes that countries should restrict the early adoption of advanced new therapies to specialized clinics with appropriate scientific and ethical expertise for review. Review in these institutions should focus on expert clinical benefit assessments for individual patients being offered such interventions, independently of whether they are offered as research or therapy. (shrink)

The presented article is devoted to the question of whether extended access therapy can or should be accompanied by research activity. It consists of three parts. The first lists the tasks that can be used for medical information regarding extended access programs, which leads to the conclusion that even taking into account the specific limitations of their cognitive value, this type of data can be meaningfully used. The second part is devoted to the limited regulations in European law concerning (...) the discussed issue, and the Polish Act on the Professions of Physician and Dentist which grants physicians/researchers broader powers. In the last part of the article, two arguments are presented to ethically justify the granting of such broad powers to researchers, and thus limiting the autonomy of patients. (shrink)

Clinical and research practices designed by developed countries are often implemented in host nations of the Third World. In recent years, a number of papers have presented a diversity of arguments to justify these practices which include the defence of research with placebos even though best proven treatments exist; the distribution of drugs unapproved in their country of origin; withholding of existing therapy in order to observe the natural course of infection and disease; redefinition of equipoise to a (...) more bland version, and denial of post-trial benefits to research subjects. These practices have all been prohibited in developed, sponsoring countries, even though they invariably have pockets of poverty where conditions comparable to the Third World prevail. Furthermore, the latest update of the Declaration of Helsinki clearly decries double ethical standards in research protocols. Under these circumstances, it does not seem appropriate that First World scholars should propose and defend research and clinical practices with less stringent ethical standards than those mandatory in their own countries. Recent years have witnessed frequent reports of less stringent ethical standards being applied to both clinical and research medical practices, for the most part in the field of drug trials and drug marketing, initiated by developed countries in poorer nations. Still more unsettling, a number of articles have endorsed the policy of employing ethical norms in these host countries, which would be unacceptable to both the legislations and the moral standards of the sponsor nations. Also, these reformulations often contravene the Declaration of Helsinki or one of its updates. This paper is not so much concerned with the actual practices, which have been subjected to frequent scrutiny and publicly decried when gross misconduct occurred. Rather, my concern relates to the approval and support such practices have found in the literature on bioethics from authors who might be expected to use their energy and scholarship to explore and endorse the universalisability of ethics rather than to develop ad hoc arguments that would allow exceptions and variations from accepted moral standards. To this purpose, issue will be taken with arguments in three fields: medical and pharmaceutical practices, research strategies, and local application of research results. (shrink)

Through expanded access protocols, the Food and Drug Administration (FDA) allows patients with serious or immediately life-threatening diseases access to experimental drugs outside the clinical trial setting when no satisfactory alternative treatment is available. While the FDA has established a mechanism for providing patients with unapproved drug access, the regulations do not require the pharmaceutical company to provide the drug. The drug company’s permission to use its experimental drug is a necessary prerequisite to using the FDA’s expanded access mechanism. (...) Increasingly, drug companies are coming under scrutiny regarding the programs governing that decision-making power. Historically, disclosing whether a company has an expanded access program, and whether or how it would respond to an expanded access request, has been left to discretion of the drug companies themselves. Few manufacturers publish adequate expanded access protocols. As a result, patients were provided with little insight into how companies evaluate expanded access requests and are naturally skeptical as to the ethical integrity of the process. The recently passed 21st Century Cures Act changes that practice by requiring drug companies to have, and make publically available, their expanded access procedures including criteria for evaluating and responding to patient requests. In this article, we contend that complying with the new transparency provisions will require drug companies to respond to several unresolved expanded access issues. Namely, how to reconcile a patient’s desire to access lifesaving experimental therapies alongside the company and society’s interest in the efficient development of new drugs. Even more challenging, how can companies devise practices for evaluating and processing expanded access requests that also fairly and equitably acknowledge those concerns? In addressing these questions, this article explores the legal, regulatory, business, and societal influences that have shaped expanded access policies and practices. From there, we provide companies a framework that balances appropriately the desires of individuals and gaining the requisite approvals ensure access not just for one person but for society. (shrink)

In recent years, anthropologists have built a rich body of ethnography on the experience of addiction, including important cultural critiques of treatment systems. Yet little has been written from the perspective of those who work in the everyday to help others recover from substance abuse. In this article, I reflect on my labor as a clinical social worker providing therapy for homeless women and men who struggle with addiction. Building on the eloquence of those who seek to recover, recovery (...) poets, I demonstrate how the work of a team of frontline workers operates in a particular intersubjective realm that creates different conditions for understanding addiction and recovery than does anthropological fieldwork. By detailing the labor of recovery as I performed it using different evidence-based therapies to permit the emergence of a new consciousness, I aim to bring to center stage the complex labor of frontline workers so that their working conditions will be taken into account more often in anthropological work on addiction and treatment. (shrink)

New technologies facilitate the enhancement of a wide range of human dispositions, capacities, or abilities. While it is argued that we need to set limits to human enhancement, it is unclear where we should find resources to set such limits. Traditional routes for setting limits, such as referring to nature, the therapy-enhancement distinction, and the health-disease distinction, turn out to have some shortcomings. However, upon closer scrutiny the concept of enhancement is based on vague conceptions of what is to (...) be enhanced. Explaining why it is better to become older, stronger, and more intelligent presupposes a clear conception of goodness, which is seldom provided. In particular, the qualitative better is frequently confused with the quantitative more. We may therefore not need “external” measures for setting its limits – they are available in the concept of enhancement itself. While there may be shortcomings in traditional sources of limit setting to human enhancement, such as nature, therapy, and disease, such approaches may not be necessary. The specification-of-betterment problem inherent in the conception of human enhancement itself provides means to restrict its unwarranted proliferation. We only need to demand clear, sustainable, obtainable goals for enhancement that are based on evidence, and not on lofty speculations, hypes, analogies, or weak associations. Human enhancements that specify what will become better, and provide adequate evidence, are good and should be pursued. Others should not be accepted. (shrink)

Undeniably, a strikingly higher number of people die with direct health care provider involvement in Canada’s euthanasia regime, euphemistically termed “Medical Assistance in Dying” [MAiD], than un...

Well-trained, competent therapists are crucial for safe and effective psychedelic-assisted therapy (PAT). The question whether PAT training programs should require aspiring therapists to undergo their own PAT—commonly referred to as “experiential training”—has received much attention within the field. In this article, we analyze the potential benefits of experiential training in PAT by applying the framework developed by Rolf Sandell et al. concerning the functions of any training therapy (the therapeutic, modeling, empathic, persuasive, and theoretical functions). We then explore (...) six key domains in which risks could arise through mandatory experiential training: physical and psychological risks; negative impact on therapeutic skill; justice, equity, diversity, and inclusion; dual relationships; privacy and confidentiality; and undue pressure. Ultimately, we argue that experiential training in PAT should not be mandatory. Because many PAT training programs already incorporate experiential training methods, our exploration of potential harms and benefits may be used to generate comprehensive risk-mitigation strategies. (shrink)

:Since the advent of recombinant DNA technology, expectations about the potential for altering genes and controlling our biology at the fundamental level have been sky high. These expectations have gone largely unfulfilled. But though the dream of being able to control our biology is still far off, gene editing research has made enormous strides toward potential clinical use. This paper argues that when it comes to determining permissible uses of gene editing in one important medical context—germline intervention in reproductive medicine—issues (...) about enhancement and eugenics are, for the foreseeable future, a red herring. Current translational goals for gene editing research involve a different kind of editing than would be required to achieve manipulation of complex traits such as intelligence, and there are more pressing questions that need attention if clinical use of gene editing in reproductive medicine ever becomes a possibility. (shrink)

Cognitive Behavioral Therapy has become the dominant form of psychotherapy in North America. The CBT model is theoretically based on the idea that all external and internal stimuli are filtered through meaning-making, consciously accessible cognitive schemas. The goal of CBT is to identify dysfunctional or maladaptive thoughts and beliefs, and replace them with more adaptive cognitive interpretations. While CBT is clearly effective as a treatment, there is good reason to be skeptical that its efficacy is due to the causal (...) mechanisms posited by the CBT model. This paper will argue that the specific cognitive schemas posited by the CBT model likely do not play a direct role in the development or treatment of psychological illness. Cognitive schemas, as identified in CBT interventions, are likely to be the result of patient confabulation and epistemically under-supported practitioner-based identification. CBT interventions appear to impose coherence on patients’ psychological states, rather than identifying and modifying preexistent causally efficacious core beliefs. (shrink)

Introduction: Evidence supporting the use of music interventions to maximize arousal and awareness in adults presenting with a disorder of consciousness continues to grow. However, the brain of a child is not simply a small adult brain, and therefore adult theories are not directly translatable to the pediatric population. The present study aims to synthesize brain imaging data about the neural processing of music in children aged 0-18 years, to form a theoretical basis for music interventions with children presenting with (...) a disorder of consciousness following acquired brain injury.Methods: We conducted a systematic review with narrative synthesis utilizing an adaptation of the methodology developed by Popay and colleagues. Following the development of the narrative that answered the central question “what does brain imaging data reveal about the receptive processing of music in children?”, discussion was centered around the clinical implications of music therapy with children following acquired brain injury.Results: The narrative synthesis included 46 studies that utilized EEG, MEG, fMRI, and fNIRS scanning techniques in children aged 0-18 years. From birth, musical stimuli elicit distinct but immature electrical responses, with components of the auditory evoked response having longer latencies and variable amplitudes compared to their adult counterparts. Hemodynamic responses are observed throughout cortical and subcortical structures however cortical immaturity impacts musical processing and the localization of function in infants and young children. The processing of complex musical stimuli continues to mature into late adolescence.Conclusion: While the ability to process fundamental musical elements is present from birth, infants and children process music more slowly and utilize different cortical areas compared to adults. Brain injury in childhood occurs in a period of rapid development and the ability to process music following brain injury will likely depend on pre-morbid musical processing. Further, a significant brain injury may disrupt the developmental trajectory of complex music processing. However, complex music processing may emerge earlier than comparative language processing, and occur throughout a more global circuitry. (shrink)

In this article we illustrate how trainers and trainees negotiate epistemic and deontic authority within systemic family therapy training. Adult education principles and postmodern imperatives have challenged trainers’ and trainees’ asymmetries regarding knowledge and power, normatively implicated by the institutional training setting. Up-to-date, we lack insight into how trainers and trainees negotiate epistemic and deontic rights in naturally occurring dialog within training. Drawing from discursive psychology and conversation analysis, we present an analysis of eight transcribed, videotaped training seminars from (...) a systemic family therapy training program, featuring three trainers and eleven trainees. Our analysis highlights the dilemmatic ways in which participants resist and affirm the normatively implicated trainers’ deontic and epistemic authority. Trainers are shown as mitigating directives and trainees as resisting them, with both displaying knowing, while attending to concerns about symmetry. We discuss our findings’ implications for systemic family therapy training. (shrink)

Chris Letheby’s defence of psychedelic therapy hinges on the premise that psychedelic-facilitated insights about the self are in a better epistemic position than those about the external world. In this commentary, I argue that such a claim is not sufficiently defended. More precisely, I argue that one element is underexplored in Letheby’s otherwise compelling picture: namely, that unlike new beliefs about the external world, beliefs about oneself have the capacity to turn into self-fulfilling prophecies. Recognising the psychedelic experience and (...) the subsequent integration process as opportunities not only to apprehend certain facts about the self but also to actively shape and redetermine those facts is key to understanding the epistemic differences between insights patients have about themselves and about the external world. (shrink)

Destination therapy is the permanent implantation of a left ventricular assist device in patients with end-stage, severe heart failure who are ineligible for heart transplantation. DT improves both the quality of life and prognosis of patients with end-stage heart failure. However, there are also downsides to DT such as life-threatening complications and the potential for the patient to live beyond their desired length of life following such major complications. Because of deeply ingrained cultural and religious beliefs regarding death and (...) the sanctity of life, Japanese society may not be ready to make changes needed to enable patients to have LVADs deactivated under certain circumstances to avoid needless suffering. Western ethical views that permit LVAD deactivation based mainly on respect for autonomy and dignity have not been accepted thus far in Japan and are unlikely to be accepted, given the current Japanese culture and traditional values. Some healthcare professionals might regard patients as ineligible for DT unless they have prepared advance directives. If this were to happen, the right to prepare an advance directive would instead become an obligation to do so. Furthermore, patient selection for DT poses another ethical issue. Given the predominant sanctity of life principle and lack of cost-consciousness regarding medical expenses, medically appropriate exclusion criteria would be ignored and DT could be applied to various patients, including very old patients, the demented, or even patients in persistent vegetative states, through on-site judgment. There is an urgent need for Japan to establish and enact a basic act for patient rights. The act should include: respect for a patient’s right to self-determination; the right to refuse unwanted treatment; the right to prepare legally binding advance directives; the right to decline to prepare such directives; and access to nationally insured healthcare. It should enable those concerned with patient care involving DT to seek ethical advice from ethics committees. Furthermore, it should state that healthcare professionals involved in the discontinuation of life support in a proper manner are immune to any legal action and that they have the right to conscientiously object to LVAD deactivation. (shrink)

Given their heterogeneity and lack of defining markers, it is surprising that multipotent mesenchymal stem/stromal cells (MSCs) have attracted so much translational attention, especially as increasing evidence points to their predominant effect being not by donor differentiation but via paracrine mediators and exosomes. Achieving long-term MSC donor chimerism for treatment of chronic disease remains a challenge, requiring enhanced MSC homing/engraftment properties and manipulation of niches to direct MSC behaviour. Meanwhile advances in nanoparticle technology are furthering the development of MSCs as (...) vehicles for targeted drug delivery. For treatment of acute injuries, systemic cell-free exosome delivery may ultimately displace current emphasis on empiric donor-cell transplantation for anti-inflammatory, immunomodulatory and repair-promoting effects. Exploration of potential clinical sources of MSCs has led to increased utilisation of perinatal MSCs in allogeneic clinical trials, reflecting their ease of collection and developmentally advantageous properties. (shrink)

Argues that Wittgenstein's early ethical notion of agreement with the world pivoted to become his later therapeutic notion of agreement with living forms, which satisfies the conditions necessary for a full therapeutic philosophy.

Introduction: Electroconvulsive therapy is a commonly used brain stimulation treatment for treatment-resistant or severe depression. This study was planned to find the effects of ECT on brain connectivity by conducting a systematic review and coordinate-based meta-analysis of the studies performing resting state fMRI in patients with depression receiving ECT.Methods: We systematically searched the databases published up to July 31, 2020, for studies in patients having depression that compared resting-state functional connectivity before and after a course of pulse wave ECT. (...) Meta-analysis was performed using the activation likelihood estimation method after extracting details about coordinates, voxel size, and method for correction of multiple comparisons corresponding to the significant clusters and the respective rsFC analysis measure with its method of extraction.Results: Among 41 articles selected for full-text review, 31 articles were included in the systematic review. Among them, 13 articles were included in the meta-analysis, and a total of 73 foci of 21 experiments were examined using activation likelihood estimation in 10 sets. Using the cluster-level interference method, one voxel-wise analysis with the measure of amplitude of low frequency fluctuations and one seed-voxel analysis with the right hippocampus showed a significant reduction in the left cingulate gyrus and a significant increase in the right hippocampus with the right parahippocampal gyrus, respectively. Another analysis with the studies implementing network-wise resting state functional connectivity showed a significant increase in bilateral posterior cingulate cortex. There was considerable variability as well as a few key deficits in the preprocessing and analysis of the neuroimages and the reporting of results in the included studies. Due to lesser studies, we could not do further analysis to address the neuroimaging variability and subject-related differences.Conclusion: The brain regions noted in this meta-analysis are reasonably specific and distinguished, and they had significant changes in resting state functional connectivity after a course of ECT for depression. More studies with better neuroimaging standards should be conducted in the future to confirm these results in different subgroups of depression and with varied aspects of ECT. (shrink)

The mental health crisis and loneliness epidemic have sparked a growing interest in leveraging artificial intelligence (AI) and chatbots as a potential solution. This report examines the benefits and risks of incorporating chatbots in mental health treatment. AI is used for mental health diagnosis and treatment decision-making and to train therapists on virtual patients. Chatbots are employed as always-available intermediaries with therapists, flagging symptoms for human intervention. But chatbots are also sold as stand-alone virtual therapists or as friends and lovers. (...) There is evidence that these uses of AI and chatbots can provide better quality service, improve accessibility, and lower costs. The systems can reduce the stigma and shame of sharing their problems and leverage a mass of biometric and behavioral data to supplement self-reports. As the systems' intelligence rapidly improves, they will need to be rigorously tested for the accuracy and precision of their diagnoses and the quality of their interactions with patients. As chatbots become indistinguishable from humans and leverage their superhuman capacity to detect affect and draw on knowledge of a patient’s life, patients will be drawn to attribute personality to and relationship with the chatbot. Consequently, it will be essential to study what the “therapeutic alliance” with an actual human counselor provides and the risks of patients attributing such a relationship to a one-sided or “parasocial” relationship. (shrink)

Deepfakes are hyper-realistic but fabricated videos created with the use of artificial intelligence. In the context of psychotherapy, the first studies on using deepfake technology are emerging, with potential applications including grief counselling and treatment for sexual violence-related trauma. This paper explores these applications from the perspective of medical ethics and health law. First, we question whether deepfake therapy can truly constitute good care. Important risks are dangerous situations or ‘triggers’ to the patient during data collection for the creation (...) of a deepfake, and when deepfake therapy is started, there are risks of overattachment and blurring of reality, which can complicate the grieving process or alter perceptions of perpetrators. Therapists must mitigate these risks, but more research is needed to evaluate deepfake therapy’s efficacy before it can be used at all. Second, we address the implications for the person depicted in the deepfake. We describe how privacy and portrait law apply and argue that the legitimate interests of those receiving therapy should outweigh the interests of the depicted, as long as the therapy is an effective and ‘last resort’ treatment option, overseen by a therapist and the deepfakes are handled carefully. We suggest specific preventative measures that can be taken to protect the depicted person’s privacy. Finally, we call for qualitative research with patients and therapists to explore dependencies and other unintended consequences. In conclusion, while deepfake therapy holds promise, the competing interests and ethicolegal complexities demand careful consideration and further investigation alongside the development and implementation of this technology. (shrink)

Retraction note: Cuadrado Cenzual, M. A., Peláez Escribá de Balaguer, G., & Castillo Charfolet, A. (2022). Alzheimer’s, music therapy & social work intervention. HUMAN REVIEW. International Humanities / Revista Internacional De Humanidades, 12(6), 2–11. https://doi.org/10.37467/revhuman.v11.4099 The Editorial Office of Eurasia Academic Publishing Group has retracted this article. An investigation carried out by our Research Integrity Department has found a group of articles, among which this one is found, that are not within the thematic scope of the journal. We believe (...) that the editorial process was manipulated and, furthermore, acceptance decisions were made under possibly inappropriate peer review. (shrink)

This chapter contains section titled: Introduction The Issue of Textual Difficulties and Style The PI Preface Baker's Contextualism Applying the Right Kind of Context Conclusions and Further Issues.

The object of this essay is to discuss Ludwig Wittgenstein's remarks inPhilosophical Investigationsand elsewhere in the posthumously published writings concerning the role of therapy in relation to philosophy. Wittgenstein's reflections seem to suggest that there is a kind of philosophy or mode of investigation targeting the philosophical grammar of language uses that gratuitously give rise to philosophical problems, and produce in many thinkers philosophical anxieties for which the proper therapy is intended to offer relief. Two possible objectives of (...) later Wittgensteinian therapy are proposed, for subjectivepsychologicalversus objectivesemanticsymptoms of ailments that a therapy might address for the sake of relieving philosophical anxieties. The psychological in its most plausible form is rejected, leaving only the semantic. Semantic therapy in the sense defined and developed is more general and long-lasting, and more in the spirit of Wittgenstein's project on a variety of levels. A semantic approach treats language rather than the thinking, language-using subject as the patient needing therapy, and directs its attention to the treatment of problems in language and the conceptual framework a language game use expresses in its philosophical grammar, rather than to soothing unhappy or socially ill-adjusted individual psychologies. (shrink)

The prescription of growth hormone therapy for children who are not growth hormone deficient is one of the controversies in contemporary paediatric endocrinology. Is it morally appropriate to enhance the growth, by means of medical treatment, of a child wish idiopathic short stature? The medical, moral, and philosophical questions in this area are many. Data on the effects of human growth hormone (hGH) treatment will not on their own provide us with answers, as these effects have to be evaluated (...) from a normative perspective. In this article we consider hGH treatment for children of idiopathic short stature from three normative perspectives: the goals of medicine, the good of the patient, and the public good. We argue that the prevention of psychological and social problems due to short stature (and not merely the enhancement of growth) should be the ultimate goal of medical treatment and research. (shrink)

Background We report a randomised controlled clinical trial of neurofeedback therapy intervention for ADHD/ADD in adults. We focus on internal mechanics of neurofeedback learning, to elucidate the primary role of cortical self-regulation in neurofeedback. We report initial results; more extensive analysis will follow. Methods Trial has two phases: intervention and follow-up. The intervention consisted of neurofeedback treatment, including intake and outtake measurements, using a waiting-list control group. Treatment involved $\sim$40 hour-long sessions 2-5 times per week. Training involved either theta/beta (...) or sensorimotor-rhythm regimes, adapted by adding a novel 'inverse-training' condition to promote self-regulation. Follow-up (ongoing) will consist of self-report and executive function tests. Setting Intake and outtake measurements were conducted at University of Helsinki. Treatment was administered at partner clinic Mental Capital Care, Helsinki. Randomisation We randomly allocated half the sample then adaptively allocated the remainder to minimise baseline differences in prognostic variables. Blinding Waiting-list control design meant trial was not blinded. Participants 54 adult Finnish participants (mean age 36 years; 29 females) were recruited after screening by psychiatric review. 44 had ADHD diagnoses, 10 had ADD. Measurements Symptoms were assessed by computerised attention test (T.O.V.A.) and self-report scales, at intake and outtake. Performance during neurofeedback trials was recorded. Results Participants were recruited and completed intake measurements during summer 2012, before assignment to treatment and control, September 2012. Outtake measurements ran April-August 2013. After dropouts, 23 treatment and 21 waiting-list participants remained for analysis. Initial analysis showed that, compared to waiting-list control, neurofeedback promoted improvement of self-reported ADHD symptoms, but did not show transfer of learning to T.O.V.A. Comprehensive analysis will be reported elsewhere. Trial Registration "Computer Enabled Neuroplasticity Treatment (CENT)", ISRCTN13915109. Partly funded by Finnish science agency TEKES, project #440078. (shrink)

In 1937, John Dewey delivered a lecture to the College of Physicians in Saint Louis. His clear message was that in the practice of medicine it does not suffice for physicians to treat just the body, or to look to just the body for the mechanism of disease. Emphasizing the relational nature of organism-environment, he argued that the physician must treat the whole patient and must therefore consider the environment of the patient. It makes no sense, he suggested, to provide (...) medicine to address a problem with the patient's lungs and then to send him back into the coal mine. As he put it: "We must observe and understand internal processes and their interactions from the standpoint of their interactions with what is... (shrink)

What does it mean “playing music together”? Is this action guided by cognitive or pre-inferential skills? The aim of this paper is to unveil the different components that are implied in a collective action such as “playing music together”. The idea which will be supported is that embodiment and temporality are the main important structures that guide the subject. In the first part, we will emphasize the centrality of corporeality in the development of self-awareness and intercorporeal understanding. In particular, drawing (...) on Merleau-Ponty’s work, we will argue that the cognitive layer of our consciousness and the pre-inferential one are simply the product of our being embodied. Another central structure for the development of selfhood and intersubjectivity is temporality: as we will show, our selfhood and our attunement with the world can be also described in terms of rhythm, whereby implicit body memory allows for the sedimentation of habits, and synchrony, when my bodily and temporalized self is able to automatically tune in with others. In the second part, we will show how these components are at stake in an action like “playing music together”: attending music therapy sessions with patients who suffer indeed from an (inter)corporeal detachment allowed us to observe the centrality of those components described in the first part of our work, that is, to show how pre-reflective features (such as implicit body memory, intercorporeality, rhythm and synchrony) are necessary for the development of higher social (and cognitive) abilities.In fact, first person reports collected through a qualitative interview applied to patients allow to support the priority of the pre-reflective, affective and (inter)bodily components over the reflective ones. (shrink)

It is no exaggeration to say that the new topic of Korean philosophy in the 21st century is humanities therapy, more specifically philosophical therapy. However, criticism that the concepts and theories that make up humanities therapy are not clear can be raised. Therefore, I think that the conceptual clarification is necessary to establish this therapy academically against the this negative criticism. The problem, I have argued, is that because the concepts used in humanities therapy are (...) value-dependent, they are not free from the Open Question Argument implicated in the matter of fact-value gap elaborated by G. E. Moore. Therefore, it is necessary to objectify the epistemological uncertainty as a physicalistic epistemological perspective, in the diagnosis and treatment process of humanities treatment. To this end, I try to clarify the concept of humanities therapy through conceptual supervenience of mental causation, and to make the process and results of the therapy cognitively transparent. (shrink)

BackgroundAcrophobia is a specific phobia characterized by a severe fear of heights. The purpose of the present study was to investigate the efficacy of two therapies that may ameliorate symptoms of acrophobia and anxiety sensitivity, i.e., virtual reality exposure therapy (VRET) and eye movement desensitization and reprocessing (EMDR) therapy with a Waiting List Control Condition (WLCC).MethodsWe applied a three-armed randomized controlled pre-post-test design with 45 female adolescent students. Students who met DSM-5 criteria for acrophobia were randomly assigned to (...) either VRET (N = 15;Mage = 17.26; SD = 1.32), EMDR (N = 15;Mage = 17.15; SD = 1.57), or a WLCC (N = 15;Mage = 17.50; SD = 1.26). The study groups were evaluated one week before the intervention and one week after the last intervention session regarding symptoms of acrophobia (Severity Measure for Acrophobia) and anxiety sensitivity (Anxiety Sensitivity Index).ResultsThe data showed that both the application of VRET and EMDR therapy were associated with significantly reduced symptoms of acrophobia (d = 1.03 for VRET and d = 1.08 for EMDR) and anxiety sensitivity (d = 1.15 for VRET and d = 1.13 for EMDR) in comparison to the Waiting List.LimitationsThe sample consisted only of adolescent women. Due to the recognizable differences between the two interventions, the therapists and the participants were not blind to the conditions.ConclusionThe results suggest that both VRET and EMDR are interventions that can significantly improve symptoms of acrophobia and anxiety sensitivity in female adolescents.Clinical Trial Registrationhttps://www.irct.ir/trial/57391, identifier: IRCT20210213050343N1. (shrink)

The development of gene therapy has always come with the expectation that it will offer a cure for various disorders, of which hemophilia is a paradigm example. However, although the term is used regularly, it is unclear what exactly is meant with “cure”. Therefore, the aim of this paper is to analyse how the concept of cure is used in practice and evaluate which of the interpretations is most suitable in discussions surrounding gene therapy. We analysed how cure (...) is used in four different medical fields where the concept raises discussion. We show that cure can be used in three different ways: cure as normalization of the body, cure as obtaining a normal life, or cure as a change in identity. We argue that since cure is a practical term, its interpretation should be context-specific and the various uses can exist simultaneously, as long as their use is suitable to the function the notion of cure plays in each of the settings. We end by highlighting three different settings in the domain of hemophilia gene therapy in which the term cure is used and explore the function(s) it serves in each setting. We conclude that in the clinical application of gene therapy, it could be better to abandon the term cure, whereas more modest and specified definitions of cure are required in the context of health resource allocation decisions and decisions on research funding. (shrink)

The use of charged-particle radiation therapy is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept (...) is best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields , including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research. (shrink)