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MIJ821 is a novel N-methyl-D-aspartate (NMDA) receptor antagonist, with a potentially low rate of the psychotomimetic side effects that limit the therapeutic utility of ketamine in treatment-refractory depression (TRD).
To assess efficacy and safety of MIJ821.
Adults with TRD (>2 prior treatment failures; Montgomery-Asberg Depression Rating Scale [MADRS], >24) were eligible and were randomized (n=70) to low versus high doses of MIJ821, with two dosing regimens of weekly or biweekly, versus ketamine versus placebo. The primary outcome was change in MADRS total score at 24 hours and final follow up was at 6 weeks.
At 24 hours, adjusted mean differences (ΔAM) versus placebo were –8.25 (p=0.001), –5.71 (p=0.019) and –5.67 (p=0.046) and at 48 h were –7.06 (p=0.013), –7.37 (p=0.013), –11.02 (p=0.019) in the pooled MIJ821 low dose, high dose, and ketamine groups, respectively. At 6 weeks, ΔAM (80% CI) versus placebo on MADRS were –6.46 (–11.8, –1.15); p=0.059 for low dose MIJ821, –5.42 (–10.8, –0.02); p=0.099) for high dose MIJ821, and –5.24 (–10.4, –0.06); p=0.097 for ketamine. Further details on dosing, efficacy, and safety outcomes will be provided.
In this proof-of-concept study, MIJ821 was effective and tolerable in TRD. This study was funded by Novartis. Clinical trial.gov: NCT03756129
In the early stage of schizophrenia (first 5 years), the most important clinical target besides symptom control is relapse prevention as each relapse significantly decreases the possibility of preferable long-term outcomes. Early discontinuation of antipsychotic medication due to intolerable side-effects is one of the most common causes of relapse.
This poster aims to present cariprazine’s tolerability in the early stage of schizophrenia.
Data from 4 randomized, double-blind, placebo-controlled trials (NCT00404573, NCT01104766, NCT01104779, NCT00694707) with similar design (1 week of wash out period, 6 weeks of treatment and 2-4 weeks of follow-up) were pooled. For the post-hoc analysis, patients with early stage of schizophrenia (defined as having a disease duration of less than 5 years) were extracted from the whole safety population, and approved doses of cariprazine (1.5-6.0 mg/day) were combined. Treatment-emergent adverse events (TEAEs) and discontinuation rates were analysed versus placebo.
Overall, 169 placebo- (PBO) and 322 cariprazine-treated (CAR) patients were identified as having schizophrenia for less than 5 years. 67.7% cariprazine- and 56.2% placebo-treated patients reported at least one TEAE; most frequently insomnia (10.9 % CAR; 12.4% PBO), akathisia (9.6% CAR; 2.4% PBO) and extrapyramidal symptoms (9.3% CAR; 1.8% PBO). Discontinuation due to adverse events was reported in only 8.4% of cariprazine- and 14.8% of placebo-treated patients. Relapse occurred in 3.1% of cariprazine- and 5.3% of placebo-treated patients.
Cariprazine was generally well-tolerated in the early stage of schizophrenia; given the limitations of this analysis, additional research is warranted.
Conflict of interest
Studies were funded by Gedeon Richter Plc. and Allergan Plc (prior to its acquisition by AbbVie). Dombi, Acsai, Dr. Barabássy, Dr. Sebe, Dr. Laszlovszky, Dr Vass, Dr. Szatmári and Dr. Németh are employees of Gedeon Richter Plc., Dr. Earley and Dr. Patel a
At Coombe Wood Mother and Baby unit (MBU) there are daily multi-disciplinary team (MDT) handover meetings and a weekly MDT ward round attended by 7-8 team members. There are concerns that the handover is too time consuming, utilising time which could be spent on other clinical duties, and concerns regarding the relevance of information that is handed over.
To perform a service evaluation to determine the efficiency and quality of MDT handover meetings in an MBU setting.
Data was collected from September to October 2020. A checklist was designed listing information felt to be relevant to handover and contained the following data points – ‘current situation’, ‘mental health’, ‘level of observations’, ‘risk’, ‘physical health’, ‘baby care’, ‘baby supervision levels’ and ‘tasks and responsibilities’. The start and stop times of each MDT handover meeting were noted and a record was made as to whether these topics were discussed.
Mean meeting duration was 32.2 minutes (range: 13 – 45 minutes) and amounted to 2.68 hours spent in MDT handover over a 5-day working week. This equates to 21.4 person-hours (based on 8 staff) a week. 928 data points were generated. 50.7% (468) data points were recorded and commonly omitted data points were – ‘tasks and responsibilities’, ‘risk’, ‘level of observations’ and ‘physical health’. On all occasions, ‘current situation’, ‘mental health’ and ‘baby care’ were handed over.
The results of this service evaluation provide compelling evidence for a wider improvement project. Involving MDT staff in designing interventions will make handover meetings more meaningful.
Antipsychotics are frequently used for managing psychiatric and behavioral symptoms of dementia. However, it’s an off-label resource which remains controversial due to significant safety concerns in the elderly population, namely increasing cardiovascular adverse effects.
To access antipsychotic safety and potential risks when used in dementia.
A non-systematic review was carefully conducted on PubMed using the following keywords: “dementia”, “antipsychotics” and “safety.” We selected clinical trials, meta-analysis, randomized controlled trials published in the last 10 years.
A total of 43 articles was obtained, of which 22 were excluded because they didn’t meet our inclusion criteria. Regarding atypical antipsychotics, one study found an incidence of severe events in 23,7% of patients and a OR=2.5 for cerebrovascular side effects. Quetiapine was suspended midway given it had a higher incidence of adverse effects compared to others. There weren’t any significant statistic differences concerning serious events between classes of antipsychotics(p<0,01). No study was found comparing typical and atypical antipsychotics safety in dementia.
Overall, we can conclude that antipsychotics pose a risk of serious adverse effects when used in elderly patients, namely cerebrovascular events. Among atypical antipsychotics, quetiapine, used frequently for controlling neuropsychiatric symptoms in these patients appears a higher risk for severe adverse events compared with other drugs. Their use should be restricted after there aren’t any other options available. New protocols could be developed to control these symptoms, for example, environmental measures before resorting to antipsychotics.
Although monotherapy is preferable, in every day clinical practice polypharmacy is often unavoidable due to the need of treatment enhancement or cross-titration phases with shorter or longer overlaps of two or more drugs. However, administration of more than one drug treatment is often associated with more side effects.
The aim of the present post-hoc analysis was to examine treatment emergent adverse events (TEAEs) during co-administration of cariprazine with other antipsychotics.
Treatment emergent adverse event data (TEAE) from a randomized, double-blind, parallel-group, active-controlled study (EudraCT Number: 2012-005485-36) in adult patients with schizophrenia having predominant negative symptoms was examined in the first two weeks of the double-blind treatment period, where gradual cross-titration occurred between cariprazine (3-6 mg/day) and other antipsychotics (including amisulpride, aripiprazole, fluphenazine, haloperidol, olanzapine, paliperidone, quetiapine, and sertindole). Thereafter, 24 weeks of cariprazine monotherapy followed.
During the cross-titration period, 17.83% of patients experienced at least one TEAE. The TEAEs were in line with the well-established safety data: nausea (2.61%), insomnia (2.17%), headache (2.17%), akathisia (1.74%) and restlessness (1.3%) were the most common. Most events were mild in severity (66.1% mild, 32.2% moderate, 1.7% severe (insomnia)).
While not definitive, and limited by small sample size, the co-administration of cariprazine with other antipsychotics did not show an unexpected safety profile or overlapping toxicities. This is an important finding, if intermittent or longer co-administration of other antipsychotics are unavoidable with cariprazine treatment.
Conflict of interest
Studies were funded by Gedeon Richter Plc. and Allergan Plc (prior to its acquisition by AbbVie). Dr Vass, Dr Barabássy, Dr Laszlovszky, Dr Sebe, Dombi, Dr Szatmári and Dr Németh are employees of Gedeon Richter Plc.
Every person on our home planet is affected by a worldwide deluge of man-made chemicals and pollutants - most of which have never been tested for safety. Our chemical emissions are six times larger than our total greenhouse gas emissions. They are in our food, our water, the air we breathe, our homes and workplaces, the things we use each day. This universal poisoning affects our minds, our bodies, our genes, our grandkids, and all life on Earth. Julian Cribb describes the full scale of the chemical catastrophe we have unleashed. He proposes a new Human Right - not to be poisoned. He maps an empowering and hopeful way forward: to rid our planet of these toxins and return Earth to the clean, healthy condition which our forebears enjoyed, and our grandchildren should too.
Schools, just like any other workplaces, are not exempt from the risk of accidents; in fact, schools are environments in which there are a range of possible hazards as well as risks that need to be considered to ensure the safety of staff, students, volunteers, parents and contractors working onsite (Queensland Government, Department of Education, 2019a). It should be remembered that schools and teachers are also responsible for the safety of staff and students during sports and swimming carnivals, school excursions and other activities that are school events but not held on the school grounds. Risk assessments and duty of care also come under the banner of WHS.
The Mental Health Act 1959 and A Hospital Plan for England and Wales in 1962 set a direction for mental health services away from inpatient and towards outpatient and community care which enjoyed support across the political spectrum. There has been a shift of focus over time from rights and recovery to marketisation, to risk and safety to modernisation and, finally, to well-being. There has been greater coherence in policy and consensus among staff in child and adolescent mental health than its adult counterpart, but service developments were hampered by chronic underfunding. Though, overall, it is probably fair to judge that mental health services in 2010 were both substantially more effective and significantly more humane than those prevailing in 1960, they have not fulfilled the aspirations held widely at the beginning of the period.
The application of a 4K display resolution three-dimensional exoscope system (Vitom 3D) was evaluated to determine the feasibility of adopting the system in ENT surgery in the coronavirus disease 2019 era and beyond.
Eighteen ENT surgeons performed structured otological tasks on fresh-frozen sheep heads using the Vitom 3D. Structured feedback of the participants’ experience was analysed.
Seventy-four per cent and 94 per cent of participants reported that the Vitom 3D was ergonomic and comfortable to use respectively. Whilst colour fidelity and image quality were very good, 50 per cent of participants reported image distortion and pixilation at the highest magnification. All participants agreed that there was an increased educational value to exoscope technology. Half the participants preferred the microscope over the Vitom 3D for fine otological work, which may reflect the learning curve.
The Vitom 3D exoscope is a promising and viable alternative for performing otological surgery when using full personal protective equipment in the coronavirus disease 2019 era.
This chapter shows how different values including security, privacy, and safety have been at stake in the design of whole-body scanners at airports. Value-sensitive design (VSD) and Design for Values are discussed as two approaches to proactively identifying and including values in engineering design. When designing for values, one may run into conflicting values that cannot be accommodated at the same time. Different strategies for dealing with value conflicts are discussed, including designing out the conflict and balancing the conflicting values in a sensible and acceptable way. This chapter does not pretend to offer the holy grail of design for ethics. Indeed, complex and ethically intricate situations will emerge in an actual design process. Instead, it offers a way to be more sensitive to these conflicts when they occur in design and to be equipped to deal with them as far as possible. The chapter further discusses responsible research and innovation in proactive thinking about technological innovation. In so doing, it extends the notion of design beyond merely technical artifacts and focuses on the process of innovation.
Applying the existing domain model in ship domain research in a restricted area can be difficult owing to multiple factors that must be considered. This study presents a new domain model that can be applied in such environments. According to Endsley's theory of situation awareness, people have their own criteria in decision making based on factors such as individual and environmental factors. To investigate these factors, 125 seafarers were interviewed and threshold values based on their awareness were examined. The factors were evaluated as the closest points of approach. Domain modelling was performed based on these seafarer awareness values; then, the existing and awareness domains were compared, revealing that the awareness-based domain of seafarers is more affected by ship manoeuvrability than by ship size and speed, unlike the findings of existing domain research. Therefore, this study presents a new domain model that is both realistic and practical in a confined area, including various factors considered by seafarers based on the awareness values formed.
This chapter suggests tools and skills that a language revitalizer might need when incorporating new technology into language revitalization. It emphasizes that skills can be acquired gradually on the basis of current needs. Technology should be integrated appropriately into language teaching, with an iterative process for evaluating which tools are the right ones for the job. Issues around privacy and safety (particularly important when working with children) and ownership (which has historically affected Indigenous and minority communities disproportionately) are addressed. Appropriate use of technology in revitalization contexts is discussed, with examples of apps that may be useful for particular purposes and domains. Much of what can be accomplished with technology is best seen as an extension of learning, and one should always choose the resource to match the need, rather than being driven by the technology. The capsules describe the applications of video documentation in Passamaquoddy to new language revival projects; lessons learned from the development of online resources in Welsh; and the digital inclusion initiative Rising Voices.
It is a well-known fact that humans are subject to circadian alterations caused by the action of sunlight. This strongly affects their behaviour and skill, making them change their level of alertness from high at daytime to low at night-time. Taking into account this biological feature, and considering that commercial shipping is one of the oldest round-the-clock activities, raises the question whether bridge watchkeepers can carry out their tasks on night shifts with the same level of alertness as on day shifts. Furthermore, night bridge watchkeeping has to be performed in darkness or very dim light to improve the visual capacity of lookouts. A sample of vessel collisions was analysed and it was find out that this kind of accident tends to be more frequent and more serious during the darkness period of the solar day.
Investigating the underlying predictors of speeding behaviour deserves the full attention of research. This study aims to examine the effects of demographic variables on the perceived deterrent mechanisms and to predict speeding behaviour to target appropriate prevention programmes. In this study, 212 randomly selected drivers having a valid car driving licence participated in an online survey. The results revealed that demographic variables influenced drivers’ perceptions towards social and legal sanctions as well as material loss. The model revealed that two sanction-related constructs, that is, legal sanction (b = −0⋅227, P = 0⋅007) and material loss (b = −0⋅218, P = 0⋅005), as well as lax perception towards traffic accident (b = −0⋅176, P = 0⋅025), were the significant predictors of speeding behaviour. These findings suggested that prevention programmes should prioritise young and single drivers. The most effective targeted prevention programmes are highlighted accordingly based on the study results.
Agitated behaviors are frequently encountered in the prehospital setting and require emergent treatment to prevent harm to patients and prehospital personnel. Chemical sedation with ketamine works faster than traditional pharmacologic agents, though it has a higher incidence of adverse events, including intubation. Outcomes following varying initial doses of prehospital intramuscular (IM) ketamine use have been incompletely described.
To determine whether using a lower dose IM ketamine protocol for agitation is associated with more favorable outcomes.
This study was a pre-/post-intervention retrospective chart review of prehospital care reports (PCRs). Adult patients who received chemical sedation in the form of IM ketamine for agitated behaviors were included. Patients were divided into two cohorts based on the standard IM ketamine dose of 4mg/kg and the lower IM dose of 3mg/kg with the option for an additional 1mg/kg if required. Primary outcomes included intubation and hospital admission. Secondary outcomes included emergency department (ED) length of stay, additional chemical or physical restraints, assaults on prehospital or ED employees, and documented adverse events.
The standard dose cohort consisted of 211 patients. The lower dose cohort consisted of 81 patients, 17 of whom received supplemental ketamine administration. Demographics did not significantly differ between the cohorts (mean age 35.14 versus 35.65 years; P = .484; and 67.8% versus 65.4% male; P = .89). Lower dose subjects were administered a lower ketamine dose (mean 3.24mg/kg) compared to the standard dose cohort (mean 3.51mg/kg). There was no statistically significant difference between the cohorts in intubation rate (14.2% versus 18.5%; P = .455), ED length of stay (14.31 versus 14.88 hours; P = .118), need for additional restraint and sedation (P = .787), or admission rate (26.1% versus 25.9%; P = .677). In the lower dose cohort, 41.2% (7/17) of patients who received supplemental ketamine doses were intubated, a higher rate than the patients in this cohort who did not receive supplemental ketamine (8/64, 12.5%; P <.01).
Access to effective, fast-acting chemical sedation is paramount for prehospital providers. No significant outcomes differences existed when a lower dose IM ketamine protocol was implemented for prehospital chemical sedation. Patients who received a second dose of ketamine had a significant increase in intubation rate. A lower dose protocol may be considered for an agitation protocol to limit the amount of medication administered to a population of high-risk patients.
This article explores grassroots practices of community safety and security in Brooklyn, New York through a framework that centers the abolitionist practices imbedded in Black neighborhood collective action. Literature on safety and security often conflates the two concepts, not considering how grounded applications of the two may produce different outcomes and approaches to community well-being. Additionally, we know little about how Black communities build safety and security from the ground up. And while academic scholarship on abolition provides a robust theoretical foundation, more examples of how communities could and do employ police abolition are needed. Utilizing archival research and oral history interviews, I argue that a crisis of police legitimacy compelled alternatives to formal policing in New York City during the urban crisis, or the postwar period of massive urban divestment and hyper-ghettoization. These efforts included masculinized security practices such as neighborhood patrols and protests, while community safety practices included forms of neighborhood sociality grounded in feminized and queer relationships of care and concern. These efforts, which critiqued institutional racism and neglect and emerged from the indigenous knowledge base and social networks of community members, provide considerations for recovering abolitionist practices in Black neighborhood collective action and implications for building alternatives to policing. This article contributes to literature on Black communities, collective action, and abolition by offering an intersectional analysis of the various ways Black social and political engagement centers on practices of safety and security and does not always fixate on conscripting a police response.
In this chapter, the evidence and use of in vitro fertilisation (IVF) add-ons in the UK is explored. In addition, the stance of professional and regulatory bodies is described. The term ‘add-on’ has been coined to describe the additional ‘extras’ to a routine or intracytoplasmic sperm injection cycle that are commonly offered to those undergoing treatment with the aim of improving livebirth rates. A summary of the highest quality available evidence for the following add-ons is presented: endometrial scratching; time-lapse imaging; assisted hatching; preimplantation genetic testing (PGT-A); endometrial receptivity array; GM-CSF containing culture media; Embryo Glue (hyaluronic acid); artificial egg activation with calcium ionophore; intracytoplasmic morphologically selected sperm injection (IMSI); physiological intracytoplasmic sperm injection (PICSI); sperm DNA test; and reproductive immunology procedures. There remains a paucity of evidence to support the routine use of add-ons based on the available randomised controlled trial and systematic review evidence. This is particularly important given that most patients pay additional fees to utilise add-ons. In order for patients to receive high- quality care in IVF clinics, clinicians must be prepared to discuss the relevant evidence regarding efficacy and safety of the specific add-on being considered.
Any field team, regardless of the professionalism of the leadership, will eventually experience a critical event. Some events will result in a subtle degradation of the team's work; others will cause emergent threats to the safety of the team. A team's sustained performance during a field season depends partly on such chance events and partly with the team's ability to plan for and respond to the dynamic environment of the field. The duty of a field leader is to conduct clear-eyed conversations and ensure that solid preparations are laid for both the group as a whole and the individual team members. Some of these plans need to be manifested by material preparations, some of which require months of forethought. This article walks readers through a two-hour exercise, giving them frameworks from business continuity and military field doctrines to understand risk. Readers will conduct a SWOT analysis, define emergencies within their organizations, and then apply risk management practices of qualitative risk assessment and all-hazards planning to develop planning priorities. By the end, readers will have built specific action plans for improving field season readiness.
Ship domain is an important theory in ship collision avoidance and an effective collision detection method. First, several classical ship domain models are used in experiments. The results show that the alarm rate is too high in busy waters, leading to greatly reduced practicality of the model. Potential collision risk cannot be detected effectively, especially for a ship with restricted manoeuvrability, which is usually regarded as an overtaken ship due to its navigation characteristics. Therefore, it is necessary to fully consider the interference of other ships to ships with limited manoeuvrability in an encounter situation. A novel ship domain model for ships with restricted manoeuvrability in busy waters is proposed. Considering the navigation characteristics of a ship with restricted manoeuvrability and the influence of the ship–ship effect, an algorithm to determine the boundary of the ship domain model is given by force and moment equations. AIS trajectory data of the North Channel of the Yangtze River Estuary are used to perform a comparative experiment, and four classical ship domain models are employed to perform comparative experiments. The results show that the alarm rates of the novel ship domain model are 7⋅608%, 15⋅131%, 55⋅785% and 7⋅608% lower than those of the other four classical models, and this outcome can effectively reduce the high false alarm rate produced by other models in this environment.