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Recent evidence brought by novel anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugates is leading to significant changes in HER2-negative breast cancer (BC) best practices. A new targetable category termed ‘HER2-low’ has been identified in tumors previously classified as ‘HER2-negative’. Daily practice in pathology and medical oncology is expected to align to current recommendations, but patient access to novel anticancer drugs across geographies might be impeded due to local challenges.

Congenital ear anomalies are regular but often overlooked occurrences. The golden standard of treatment has been to surgically correct these anomalies at a minimum age of 5 to 7 years. As of the last century, ear molding has developed to be a safe, reliable, and effective treatment method. Different treatment methods are still under investigation. This study aims to investigate the use of the EarWell Infant Corrective System in the Dutch population. Children aged 0–12 weeks were included in the Zuyderland Medical Center to be treated with the EarWell Infant Corrective System in case of ear deformations. Every 2 weeks, the system was replaced and correction was evaluated by both physician and parents. Seventy-three participants were included, of whom 123 ears in total were treated. Age at initiation was 35.5 days on average; treatment lasted an average of 59 days. Parents and physicians both reported an amelioration of all ear anomalies after treatment, scoring the correction grade an 8.8. Overall satisfaction with the treatment method was 9 or higher for both groups. The EarWell Infant Corrective System is a safe, reliable, and effective treatment method for the correction of ear anomalies in infants. [ABSTRACT FROM AUTHOR]

Background and purpose: Therapy for myasthenia gravis (MG) is undergoing a profound change, with new treatments being tested. These include complement inhibitors and neonatal Fc receptor (FcRn) blockers. The aim of this study was to perform a meta‐analysis and network meta‐analysis of randomized and placebo‐controlled trials of innovative therapies in MG with available efficacy data. Methods: We assessed statistical heterogeneity across trials based on the Cochrane Q test and I2 values, and mean differences were pooled using the random‐effects model. Treatment efficacy was assessed after 26 weeks of eculizumab and ravulizumab, 28 days of efgartigimod, 43 days of rozanolixizumab, 12 weeks of zilucoplan, and 16, 24 or 52 weeks of rituximab treatment. Results: We observed an overall mean Myasthenia Gravis‐Activities of Daily Living scale (MG‐ADL) score change of −2.17 points (95% confidence interval [CI] −2.67, −1.67; p < 0.001) as compared to placebo. No significant difference emerged between complement inhibitors and anti‐FcRn treatment (p = 0.16). The change in Quantitative Myasthenia Gravis scale (QMG) score was −3.46 (95% CI −4.53, −2.39; p < 0.001), with a higher reduction with FcRns (−4.78 vs. −2.60; p < 0.001). Rituximab did not significantly improve the MG‐ADL (−0.92 [95% CI −2.24, 0.39]; p = 0.17) or QMG scores (−1.9 [95% CI −3.97, 0.18]; p = 0.07). In the network meta‐analysis, efgartigimod had the highest probability of being the best treatment, followed by rozanolixizumab. Conclusion: Anti‐complement and FcRn treatments both proved to be effective in MG patients, whereas rituximab did not show a significant benefit for patients. Within the limitations of this meta‐analysis, including efficacy time points, FcRn treatments showed a greater effect on QMG score in the short term. Real‐life studies with long‐term measurements are needed to confirm our results. [ABSTRACT FROM AUTHOR]

Cancer continues to pose a substantial worldwide health burden, hence requiring the advancement of novel treatment strategies. Resistance to conventional cancer treatments is a common occurrence, partially ascribed to the existence of Drug-Tolerant persistent cells (DTPCs). These cellular entities, constituting a minor proportion of the populace, possess the ability to withstand therapeutic interventions and instigate a recurrence of cancer. The current work aims to explore the recent advancements in cancer treatment by explicitly targeting Glutathione Peroxidase 4 (GPX4) in DTPCs. The current methodologies have encountered difficulties in effectively addressing DTPCs, resulting in obstacles in attaining sustained remission over an extended period. The GP-DTPC technique, which is being offered, presents a unique approach aimed at improving the survival rate, expression of drug efflux pumps, clonogenic survival, and reduction of Reactive Oxygen Species (ROS) levels in drug-tolerant persister cells. The GP-DTPC exhibits a mean performance with a Survival Rate of 88.55%, Drug Efflux Pump Expression of 1.64, Clonogenic Survival of 88.55%, ROS Levels of 234.27, and Mitophagy Activity of 1.49, surpassing other methodologies. The findings indicate the potential efficacy of targeting GPX4 in DTPCs, which might provide a novel strategy for addressing cancer, reducing the risk of recurrence, and enhancing long-term patient prognosis. This work explores novel approaches in cancer therapy by investigating the mechanisms behind the long-term survival and resistance to drugs shown by persister cells [ABSTRACT FROM AUTHOR]

This case report describes a 59-year-old male patient after heart and kidney transplantation, subsequently diagnosed with refractory hypertension since implemented antihypertensive pharmacotherapy consisting of six agents did not provide a substantial therapeutic response. Elevated blood pressure and its impact on a hypertrophied transplanted heart and impaired renal graft function have led to a significant deterioration in the patient's cardiovascular risk profile. To address this issue, a native renal arteries denervation was performed. It resulted in a noteworthy decrease in both systolic and diastolic pressure values, thus manifesting a positive hypotensive effect. Furthermore, a sustainable reduction of left ventricular mass and stabilization in kidney graft function were noticed. The presented case provides evidence that renal denervation can be an efficacious complementary treatment method in individuals who received kidney and heart grafts as it leads to a decrease in cardiovascular risk. [ABSTRACT FROM AUTHOR]

Chronic kidney disease (CKD) is a global public healthcare concern in the pediatric population, where glomerulopathies represent the second most common cause. Although classification and diagnosis of glomerulopathies still rely mostly on histopathological patterns, patient stratification should complement information supplied by kidney biopsy with clinical data and etiological criteria. Genetic determinants of glomerular injury are particularly relevant in children, with important implications for prognosis and treatment. Targeted therapies addressing the primary cause of the disease are available for a limited number of glomerular diseases. Consequently, in the majority of cases, the treatment of glomerulopathies is actually the treatment of CKD. The efficacy of the currently available strategies is limited, but new prospects evolve. Although the exact mechanisms of action are still under investigation, accumulating data in adults demonstrate the efficacy of sodium-glucose transporter 2 inhibitors (SGLT2i) in slowing the progression of CKD due to diabetic and non-diabetic kidney disease. SGLT2i has proved effective on other comorbidities, such as obesity, glycemic control, and cardiovascular risk that frequently accompany CKD. The use of SGLT2i is not yet approved in children. However, no pathophysiological clues theoretically exclude their application. The hallmark of pediatric CKD is the inevitable imbalance between the metabolic needs of a growing child and the functional capacity of a failing kidney to handle those needs. In this view, developing better strategies to address any modifiable progressor in kidney disease is mandatory, especially considering the long lifespan typical of the pediatric population. By improving the hemodynamic adaptation of the kidney and providing additional beneficial effects on the overall complications of CKD, SGLT2i is a candidate as a potentially innovative drug for the treatment of CKD and glomerular diseases in children. [ABSTRACT FROM AUTHOR]

This case report describes a 59-year-old male patient after heart and kidney transplantation, subsequently diagnosed with refractory hypertension since implemented antihypertensive pharmacotherapy consisting of six agents did not provide a substantial therapeutic response. Elevated blood pressure and its impact on a hypertrophied transplanted heart and impaired renal graft function have led to a significant deterioration in the patient’s cardiovascular risk profile. To address this issue, a native renal arteries denervation was performed. It resulted in a noteworthy decrease in both systolic and diastolic pressure values, thus manifesting a positive hypotensive effect. Furthermore, a sustainable reduction of left ventricular mass and stabilization in kidney graft function were noticed. The presented case provides evidence that renal denervation can be an efficacious complementary treatment method in individuals who received kidney and heart grafts as it leads to a decrease in cardiovascular risk.

Medical treatment for adolescents with gender dysphoria has attracted considerable attention in recent years, with continuing court involvement in Australia and recent judicial review proceedings in the UK. In Re Imogen [No 6] , the Family Court of Australia held that an application to the Family Court is mandatory if a parent or a medical practitioner of an adolescent diagnosed with gender dysphoria disputes the diagnosis, the adolescent's capacity to consent, or the proposed treatment. In this article, we examine the Family Court's rationale for preserving its welfare jurisdiction in gender dysphoria cases. We analyse case law developments in Australia and more recently in the UK and identify a thread of judicial discomfort in gender dysphoria jurisprudence about adolescents consenting to medical treatment that the court perceives to be 'innovative', 'experimental', 'unique', or 'controversial'. We explore whether treatment for gender dysphoria can be characterised as 'innovative' and identify four factors that appear to be influencing courts in Australia and the UK. We also consider how such a characterisation might impact (if at all) on an adolescent's capacity to consent to gender dysphoria treatment. We critique the ongoing role of courts in these cases and recommend a robust decision-making framework for gender dysphoria treatment to minimise court involvement in the future. [ABSTRACT FROM AUTHOR]

Chronic hepatitis B (CHB) is a highly complicated pathological process in which the disease is initiated by the hepatitis B virus (HBV); however, host immune responses are primarily responsible for variable extents of liver damage. If the patients with CHB remain untreated, many CHB patients will eventually develop complications like cirrhosis of the liver (LC) and hepatocellular carcinoma (HCC). In 2019, an estimated 882,000 patients died due to HBV-related complications worldwide. Accordingly, several drugs with antiviral properties have been used to treat CHB patients during the last four decades. However, the treatment outcome is not satisfactory because viral suppression is not usually related to the containment of progressive liver damage. Although proper reconstruction of host immunity is essential in CHB patients, as of today, there is no acceptable immune therapeutic protocol for them. These realities have exposed new, novel, and innovative therapeutic regimens for the management of CHB patients. This review will update the scope and limitation of the different innovative antiviral and immune therapeutic approaches for restoring effective host immunity and containing the virus in CHB patients to block progression to LC and HCC. [ABSTRACT FROM AUTHOR]

There seems to be a consensus that enucleated oocyte donation (EOD) should only be used to reduce the risk of having a child with mitochondrial disorders. However, this paper argues that in the initial phase in which we are at the moment, EOD should first be used to remedy infertility caused by poor oocyte quality or poor embryonic development. That learning period will allow researchers to improve their technical skills and the knowledge of the best procedure before starting on high-risk cases. Mitochondrial carryover of pathologic mtDNA is the main cause of concern for the offspring. That risk does not exist in infertility cases. The application of EOD to treat infertility should at present be performed in a clinical research setting to obtain more evidence about efficacy and safety. [ABSTRACT FROM AUTHOR]

Introduction: Obturation is used to seal and prevent reinfection of the cleansed, shaped, and disinfected root canal system. It has been stressed that excellent obturation should result in a good seal, which encompasses the apical, coronal, and lateral seals. There are several obturation procedures available, with no variation in long-term results, and no approach that eliminates leaking. The aim of the study is to determine the most commonly used Obturation technique for endodontic treatment of Maxillary permanent canines. Materials and method: In this retrospective study, the data was collected from the hospital database and further analysis was done and the results were tabulated.A statistical analysis of the collected data regarding the variance among the different obturation techniques used for the treatment of maxillary permanent canines. Results: The study sample consisted of 957 patients. Out of 957 patients, 52.42% underwent endodontic treatment for the maxillary left permanent canine, and 47.58% underwent endodontic treatment for the maxillary right permanent canine. When it comes to the Obturation technique used, 58.65% of the population used Lateral compaction technique and 41.35% of the population underwent Matched taper single cone technique. Discussion: While other techniques call for a wider flare and the unnecessary removal of sound enamel for easier instrumentation, cold lateral compaction offers caries-guided removal of tooth structure. Hence, it is the preferred obturation technique for maxillary canines. While each technique has its advantages and disadvantages, it is safe to say that most dentists employ the technique which they are more knowledgeable on. Other factors that contribute to the technique chosen include the anatomical intricacies of the affected tooth, armamentarium and material availability, cost, patient's willingness to comply, etc. Conclusion: It can be concluded that Cold Lateral compaction is the most commonly used obturation technique to treat maxillary permanent canines. [ABSTRACT FROM AUTHOR]

Rare diseases, despite their low individual prevalence, affect a large number of children. Their management has considerably improved recently due to new treatments, modifying the diseases evolution without being totally curative. Since this raises many ethical dilemmas, we present a study about respecting the principles of medical ethics in the management of rare diseases in pediatrics. We carried out a qualitative study in a French pediatric neurology department. In our study, we included health caregivers and parents of children being monitored for rare diseases and benefiting from innovative therapies. We conducted semi-structured interviews and, after transcription, we performed computerized and manual analysis. A total of 26 participants were included. Six main themes were addressed: rare diseases, science and medical research, general disease management, specific innovative treatments, neonatal screening, and cost of these treatments. Discussions centered on the children. Particular importance was given to the notions of information and the physician/family relationship. A major place is given to the treatment objectives and the improvement of quality of life. We also noted a sense of satisfaction with the current overall management of these diseases. Our study suggests that our current practice, including the use of innovative therapies, respects the four main ethical principles, from the points of view of both caregivers and parents. [ABSTRACT FROM AUTHOR]

Chronic hepatitis B (CHB) is a highly complicated pathological process in which the disease is initiated by the hepatitis B virus (HBV); however, host immune responses are primarily responsible for variable extents of liver damage. If the patients with CHB remain untreated, many CHB patients will eventually develop complications like cirrhosis of the liver (LC) and hepatocellular carcinoma (HCC). In 2019, an estimated 882,000 patients died due to HBV-related complications worldwide. Accordingly, several drugs with antiviral properties have been used to treat CHB patients during the last four decades. However, the treatment outcome is not satisfactory because viral suppression is not usually related to the containment of progressive liver damage. Although proper reconstruction of host immunity is essential in CHB patients, as of today, there is no acceptable immune therapeutic protocol for them. These realities have exposed new, novel, and innovative therapeutic regimens for the management of CHB patients. This review will update the scope and limitation of the different innovative antiviral and immune therapeutic approaches for restoring effective host immunity and containing the virus in CHB patients to block progression to LC and HCC.

Mental and substance use disorders have been identified as the leading cause of global disability, and the global burden of mental illness is concentrated among those experiencing disability due to serious mental illness (SMI). Music has been studied as a support for SMIs for decades, with promising results; however, a lack of synthesized evidence has precluded increased uptake of and access to music-based approaches. The purpose of this scoping review was to identify the types and quantity of research at intersections of music and SMIs, document evidentiary gaps and opportunities, and generate recommendations for improving research and practice. Studies were included if they reported on music's utilization in treating or mitigating symptoms related to five SMIs: schizophrenia, bipolar disorder, generalized anxiety disorder, major depressive disorder, or post-traumatic stress disorder. Eight databases were searched; screening resulted in 349 included studies for data extraction. Schizophrenia was the most studied SMI, with bipolar disorder studied the least. Demographics, settings, and activity details were found to be inconsistently and insufficiently reported; however, listening to recorded music emerged as the most common musical activity, and activity details appeared to have been affected by the conditions under study. RCTs were the predominant study design, and 271 unique measures were utilized across 289 primary studies. Over two-thirds of primary studies (68.5%) reported positive results, with 2.8% reporting worse results than the comparator, and 12% producing indeterminate results. A key finding is that evidence synthesis is precluded by insufficient reporting, widely varied outcomes and measures, and intervention complexity; as a result, widespread changes are necessary to reduce heterogeneity (as feasible), increase replicability and transferability, and improve understandings of mechanisms and causal pathways. To that end, five detailed recommendations are offered to support the sharing and development of information across disciplines.

Mental and substance use disorders have been identified as the leading cause of global disability, and the global burden of mental illness is concentrated among those experiencing disability due to serious mental illness (SMI). Music has been studied as a support for SMIs for decades, with promising results; however, a lack of synthesized evidence has precluded increased uptake of and access to music-based approaches. The purpose of this scoping review was to identify the types and quantity of research at intersections of music and SMIs, document evidentiary gaps and opportunities, and generate recommendations for improving research and practice. Studies were included if they reported on music's utilization in treating or mitigating symptoms related to five SMIs: schizophrenia, bipolar disorder, generalized anxiety disorder, major depressive disorder, or post-traumatic stress disorder. Eight databases were searched; screening resulted in 349 included studies for data extraction. Schizophrenia was the most studied SMI, with bipolar disorder studied the least. Demographics, settings, and activity details were found to be inconsistently and insufficiently reported; however, listening to recorded music emerged as the most common musical activity, and activity details appeared to have been affected by the conditions under study. RCTs were the predominant study design, and 271 unique measures were utilized across 289 primary studies. Over two-thirds of primary studies (68.5%) reported positive results, with 2.8% reporting worse results than the comparator, and 12% producing indeterminate results. A key finding is that evidence synthesis is precluded by insufficient reporting, widely varied outcomes and measures, and intervention complexity; as a result, widespread changes are necessary to reduce heterogeneity (as feasible), increase replicability and transferability, and improve understandings of mechanisms and causal pathways. To that end, five detailed recommendations are offered to support the sharing and development of information across disciplines. [ABSTRACT FROM AUTHOR]

The Department of Hematology-Immunology, headed by Professor Jean-Hugues Dalle, is the leading department in France for the care of patients receiving pediatric hematopoietic stem cell transplants. Since 2018, it has been a "major player" in the development of innovative treatments, such as gene therapy. To date, it is the only care service in France, which offers this treatment to stop the neurodegenerative progression of two genetic diseases, in collaboration with the neuropediatric service of the Kremlin-Bicêtre hospital headed by Prof Kumaran Deiva, in conjunction with the national reference center for rare disaeses didicated to leucodystrophies. It is a complex care that requires all the actors a cooperation (parents-children-caregivers)., (Copyright © 2024 Elsevier Masson SAS. All rights reserved.)

In 2017 and 2019, two research teams claimed 'proof of principle' for artificial womb technology (AWT). AWT has long been a subject of speculation in bioethical literature, with broad consensus that it is a welcome development. Despite this, little attention is afforded to more immediate ethical problems in the development of AWT, particularly as an alternative to neonatal intensive care. To start this conversation, I consider whether experimental AWT is innovative treatment or medical research. The research–treatment distinction, pervasive in regulation worldwide, is intended to isolate research activities and subject them to a greater degree of oversight. I argue that there is a tendency in the literature to conceptualize AWT for partial ectogenesis as innovative treatment. However, there are sufficiently serious ethical concerns with experimental AWT that mean that it must not be first used on humans on the basis that it is a 'beneficial treatment'. First, I outline the prospects for translation of AWT animal studies into treatment for human preterms. Second, I challenge the conceptualizations of experimental AWT as innovative treatment. It must be considered medical research to reflect the investigatory nature of the process and guarantee sufficient protections for subjects. Identifying that AWT is research is crucial in formulating further ethico‐legal questions regarding the experimental use of AWT. Third, I demonstrate that clinical trials will be a necessary part of the clinical translation of AWT because of requirements laid out by regulators. I consider the justification for clinical trials and highlight some of the crucial ethical questions about the conditions under which they should proceed. [ABSTRACT FROM AUTHOR]

This article explores and contrasts the current legal regulation of innovative treatment and health research in England. First, it explores what actually constitutes 'innovative' treatment and considers the piecemeal regulatory structures which exist in relation to innovative treatment in England. Secondly, it contrasts this with the current regulation of clinical research post-Nuremberg and the Declaration of Helsinki. Thirdly, it explores the impact of the Access to Medical Treatments (Innovation) Act 2016 and what this might mean for future regulation in this area. Fourthly, the paper suggests that it is time for a radical reconsideration of new 'innovative' or 'experimental' procedures and explores alternative approaches which could be utilised. It concludes by arguing that the regulation of innovative treatment in England is currently inadequate and provides insufficient safeguards for patients and that legislative reform is required. [ABSTRACT FROM AUTHOR]

Much political, media and academic attention has focused on: (1) the legal test for evaluating whether there has been a breach of duty in the provision of innovative treatment; and (2) the extent to which the law reform proposed by Lord Saatchi in the Medical Innovation Bill (MIB) was necessary or desirable to relieve doctors of (perceived) legal strictures preventing innovative treatments. However, comparatively little attention has focused on the requirement that patients must provide consent to innovative treatment. In this paper we argue that the English and Australian law relating to consent is capable of application in the context of innovative treatment so as to provide certainty for health professionals and promote patient autonomy. [ABSTRACT FROM AUTHOR]

EnterohemorrhagicEscherichia coli(EHEC) are major food-borne pathogens that constitute a serious public health threat. Currently, there is no specific treatment available for EHEC infections in human creating an urgent need for the development of alternative therapeutic strategies. Among them, one of the most promising approaches is the use of probiotic microorganisms. Even if many studies have shown the antagonistic effects of probiotic bacteria or yeast on EHEC survival, virulence, adhesion on intestinal epithelium or pathogen-induced inflammatory responses, mechanisms mediating their beneficial effects remain unclear. This review describes EHEC pathogenesis and novel therapeutic strategies, with a particular emphasis on probiotics. The interests and limits of a probiotic-based approach and the way it might be incorporated into global health strategies against EHEC infections will be discussed. [ABSTRACT FROM AUTHOR]

Background: A clean-cut separation between research and care was artificially created at the time of the Belmont report more than 40 years ago. The demarcation was initially controversial but eventually was implemented for political reasons. We examine why it must be revised., Methods: We review historical research scandals as well as the theoretical basis for the Belmont demarcation. We then discuss consequences on medical practice and propose an alternative., Discussion: Most research scandals involved abusing human beings supposedly for the sake of science. Belmont commissioners were aware the research/care problem was double-headed. While research subjects should be protected from abuse in the research context, patients need to be protected from unvalidated medical and surgical interventions in the care context. For political reasons the Commission recommended the regulation of research but to leave medical practice untouched. Thus the Commission had to distinguish research from care. The notion of 'generalizable knowledge' was introduced to define and regulate research, but the inadvertent result was that by trying to protect research subjects, the regulation has not only failed to protect all other patients, but also encouraged the widespread practice of unvalidated interventions within the care context. The notion of validated care should be re-introduced into a proper analysis of the care-research demarcation, for care research is an integral ingredient of a good medical practice., Conclusion: The research-care demarcation should be revised to leave room for the validated/unvalidated care distinction. Care research, essential to guide medical practice, should be facilitated at all levels., (Copyright © 2022 Elsevier Masson SAS. All rights reserved.)

Electrolyzed water (EW) has recently attracted much attention due to its efficacy against a broad spectrum of microorganisms. In this study, we investigated the impact of two EW treatments (40 and 400 mg/L free chlorine) on grape mycobiota using culture-dependent and -independent approaches. Moreover, the effect of yeast inoculation on treated and non-treated grapes was also considered. At the end of the fermentation, the wines produced were subjected to chemical and aroma analyses. The results revealed a decrease of about 0.5 log CFU/mL of the total yeast population on grapes surface independently of the dose of EW applied. Yeast inoculation and EW treatments shortened the time needed by Saccharomyces cerevisiae to dominate apiculate yeasts, particularly, 2 days for inoculated and 7 days for spontaneous fermentations. A decrease of acetic acid (about 55%) was also observed compared to untreated spontaneous fermentation. In addition, aroma analysis highlighted a positive contribution of inoculated yeast on the wine aromas, since they had approximately 50 % higher pleasant esters compared to spontaneous fermented wines. Industrial Relevance: Sulfur dioxide is widely used in crushed grapes prior to fermentation due to its antimicrobial and antioxidant activity. However, legislative rules, health risks and negative consumer perception related to its presence and use have resulted in a need to find new sanitizers able to reduce its use. The effectiveness of EW to reduce yeast species able to produce high levels of undesirable compounds was demonstrated. This research introduced an innovative antimicrobial agent, which could assist in the first step of wine production to reduce the use of SO 2 . [ABSTRACT FROM AUTHOR]

This commentary critically examines the role of the law in the conflict over the postoperative care of five-year-old Ashya King. It argues that misunderstanding, threats, and fear of the law contributed to the deteriorating relationship between his parents and the professionals caring for him. The commentary analyses the judgment, in wardship proceedings, of Baker J arguing that too much weight was placed upon the responsibilities of Ashya's parents and an insufficient account provided of his best interests or of the principled basis for preferring innovative and, as yet, unproven therapy only available, privately funded, abroad to conventional treatment for a child with a life-threatening condition. [ABSTRACT FROM AUTHOR]

Developments in medical technology, healthcare delivery, and commercial interests in medicine have increased both the potential for conflicts of interest on the part of physicians, and doubts over the sufficiency of patient autonomy as a justification for administering innovative therapy. The legal and regulatory treatment of innovative therapy is therefore an important question, on which there is a current lack of consensus on a number of issues. This paper discusses recent developments in Singapore and uses them as a springboard to flesh out basic regulatory issues that arise from the deployment of innovative treatment: the distinction between innovative treatment and clinical research, the adequacy of the current post hoc scrutiny of innovative therapy under existing legal principles and the need for further specialised regulatory oversight. [ABSTRACT FROM AUTHOR]

The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the 'boundaries' between research and practice in the Belmont Report (1978) . Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets of activities and interventions. This model is still the standard in federal regulations today. However, the Commission's deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons. [ABSTRACT FROM AUTHOR]

This study examined the wilderness therapy process in order to better understand how the intervention effects change in problem behavior of adolescent clients. A review of literature reveals multiple definitions of wilderness therapy, numerous studies evaluating treatment outcomes, and a need to focus research on how the process facilitates change. This study investigated four established wilderness therapy programs using a multisite case study approach and a variety of qualitative data collection methods to carefully examine the wilderness therapy experience of 12 clients in four wilderness therapy programs. Findings indicate that physical exercise and hiking, primitive wilderness living, peer feedback facilitated by group counseling sessions, and the therapeutic relationship established with wilderness guides and therapists were key change agents for adolescents. These factors helped adolescents come to terms with their behavior and facilitated a desire to want to change for the better. [ABSTRACT FROM AUTHOR]

We report the results of an expanded analysis of the impact of a Family Empowerment Intervention on twelve months recidivism among youths processed at the Hillsborough County Juvenile Assessment Center. Continuing, promising results were obtained. In particular, youths receiving Family Empowerment Intervention services had a reduced rate of subsequent arrests for property felonies and a new arrest in one or more of seven specific offense categories. [ABSTRACT FROM PUBLISHER]

Neuromyelitis optica spectrum disorder (NMOSD) is a group of severe inflammatory demyelinating disorders of the central nervous system that involves the optic nerve and spinal cord. Currently the therapeutic options for an acute attack in NMOSD are limited and rarely characterized in clinical studies. This review discussed the overall characteristics of acute attack of NMOSD, related risk factor, prognosis and management. Considering the huge unmet needs and the emergence of new therapeutic targets, we also reviewed innovative treatments that might alleviate attack damage, along with the challenges to evaluate new drug for acute attack in NMOSD. Unlabelled Image • Concept of NMOSD and core clinical features of diagnostic criteria changes. • Understanding of pathogenesis of NMOSD helps selection of therapeutic targets. • Acute attack/relapse of NMOSD has severe clinical consequence and risk factors. • Treatments with innovative mechanisms provide advantages over current therapies. [ABSTRACT FROM AUTHOR]