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Olanzapine effectively treats schizophrenia and bipolar I disorder (BD-I); however, its use is hindered by significant weight gain. A combination of olanzapine and samidorphan (OLZ/SAM) is in development to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain through opioid-receptor blockade. Here, we summarize OLZ/SAM clinical data.
The OLZ/SAM development program consists of 18 phase 1–3 clinical studies evaluating antipsychotic and weight mitigation efficacy of OLZ/SAM, along with pharmacokinetics, safety, and tolerability. Safety evaluation also included metabolic laboratory assessments.
OLZ/SAM significantly improved psychotic symptoms (measured by Positive and Negative Syndrome Scale); improvements were similar to that observed with olanzapine vs placebo. OLZ/SAM resulted in significantly less weight gain than olanzapine. Additionally, 2 long-term phase 3 extension studies confirmed the durability of antipsychotic effect, as well as stabilization of weight and metabolic parameters in those continuing treatment. Supporting the potential use of OLZ/SAM in BD-I, OLZ/SAM or olanzapine resulted in bioequivalent olanzapine plasma concentrations, and OLZ/SAM did not affect lithium or valproate pharmacokinetics. OLZ/SAM treatment had no clinically relevant effects on ECG parameters (including QTc interval). OLZ/SAM and olanzapine safety were similar, except for reduced weight gain with OLZ/SAM; no additional safety risks were identified.
Data across 18 OLZ/SAM studies in >1600 subjects support an antipsychotic efficacy and safety profile for OLZ/SAM that is similar to olanzapine, with significantly less weight gain than olanzapine. OLZ/SAM is a potential new treatment for schizophrenia and BD-I patients needing efficacious long-term treatment with reduced risk of weight gain.
Expectant parents who live through perinatal loss experience intense grief, which is not always acknowledged or accepted. A screening tool to detect bereaved parents’ grief reactions can guide professionals, including perinatal palliative care teams, to provide follow-up for those in need. This review's goal is to identify and synthesize the international published literature on existent instruments specifically measuring the grieving process after any perinatal loss and to identify factors that could moderate grief reactions.
Systematic review (PROSPERO # CRD42018092555) with critical synthesis. PUBMED, Cochrane, and PsycINFO databases were searched in English language articles using the keywords “perinatal” AND (“grief” OR “bereavement” OR mourning) AND (“scale” OR “questionnaire” OR “measure” OR “assessment”) up to May 2018. Eligibility criteria included every study using a measure to assess perinatal grief after all kinds of perinatal losses, including validations and translations to other languages and interventions designed to alleviate grief symptoms.
A total of 67 papers met inclusion criteria. Seven instruments measuring perinatal grief published between 1984 and 2002 are described. The Perinatal Grief Scale (PGS) was used in 53 of the selected studies. Of those, 39 analyzed factors associated with grief reactions. Six articles used PGS scores to evaluate pre- and post-bereavement interventions. Studies in English language only might have limited the number of articles.
Significance of results
The PGS is the most used standardized measures to assess grief after perinatal loss. All parents living through any kind of perinatal loss should be screened.
To evaluate the validity and reproducibility of a 152-item semi-quantitative FFQ (SFFQ) for estimating flavonoid intakes.
Over a 1-year period, participants completed two SFFQ and two weighed 7-d dietary records (7DDR). Flavonoid intakes from the SFFQ were estimated separately using Harvard (SFFQHarvard) and Phenol-Explorer (SFFQPE) food composition databases. 7DDR flavonoid intakes were derived using the Phenol-Explorer database (7DDRPE). Validity was assessed using Spearman’s rank correlation coefficients deattenuated for random measurement error (rs), and reproducibility was assessed using rank intraclass correlation coefficients.
This validation study included primarily participants from two large observational cohort studies.
Six hundred forty-one men and 724 women.
When compared with two 7DDRPE, the validity of total flavonoid intake assessed by SFFQPE was high for both men and women (rs = 0·77 and rs = 0·74, respectively). The rs for flavonoid subclasses ranged from 0·47 for flavones to 0·78 for anthocyanins in men and from 0·46 for flavonols to 0·77 for anthocyanins in women. We observed similarly moderate (0·4–0·7) to high (≥0·7) validity when using SFFQHarvard estimates, except for flavonesHarvard (rs = 0·25 for men and rs = 0·19 for women). The SFFQ demonstrated high reproducibility for total flavonoid and flavonoid subclass intake estimates when using either food composition database. The intraclass correlation coefficients ranged from 0·69 (flavonolsPE) to 0·80 (proanthocyanidinsPE) in men and from 0·67 (flavonolsPE) to 0·77 (flavan-3-ol monomersHarvard) in women.
SFFQ-derived intakes of total flavonoids and flavonoid subclasses (except for flavones) are valid and reproducible for both men and women.
Headlines touted a “wave” of women and minority candidates running in the 2018 elections, leading some to conclude that 2018 was the new “year of the woman” and perhaps “year of the candidate of color” (Lai et al. 2018). In fact, the number of women and candidates of color contesting US House elections was so high in 2018 that for the first time on record, White men were the minority of Democratic House nominees (Schneider 2018). Surveys taken immediately before the 2018 midterm elections indicated that women of color were the “ideal candidates” for Democrats, suggesting a changing voter demand for a more diverse field of candidates (Easley 2018).
The COVID-19 pandemic has created a high demand on personal protective equipment, including disposable N95 masks. Given the need for mask reuse, we tested the feasibility of vaporized hydrogen peroxide (VHP), ultraviolet light (UV), and ethanol decontamination strategies on N95 mask integrity and the ability to remove the infectious potential of SARS-CoV-2.
Disposable N95 masks, including medical grade (1860, 1870+) and industrial grade (8511) masks, were treated by VHP, UV, and ethanol decontamination. Mask degradation was tested using a quantitative respirator fit testing. Pooled clinical samples of SARS-CoV-2 were applied to mask samples, treated, and then either sent immediately for real-time reverse transcriptase–polymerase chain reaction (RT-PCR) or incubated with Vero E6 cells to assess for virucidal effect.
Both ethanol and UV decontamination showed functional degradation to different degrees while VHP treatment showed no significant change after two treatments. We also report a single SARS-CoV-2 virucidal experiment using Vero E6 cell infection in which only ethanol treatment eliminated detectable SARS-CoV-2 RNA.
We hope our data will guide further research for evidenced-based decisions for disposable N95 mask reuse and help protect caregivers from SARS-CoV-2 and other pathogens.
Spinal muscular atrophy (SMA) is a devastating rare disease that affects individuals regardless of ethnicity, gender, and age. The first-approved disease-modifying therapy for SMA, nusinursen, was approved by Health Canada, as well as by American and European regulatory agencies following positive clinical trial outcomes. The trials were conducted in a narrow pediatric population defined by age, severity, and genotype. Broad approval of therapy necessitates close follow-up of potential rare adverse events and effectiveness in the larger real-world population.
The Canadian Neuromuscular Disease Registry (CNDR) undertook an iterative multi-stakeholder process to expand the existing SMA dataset to capture items relevant to patient outcomes in a post-marketing environment. The CNDR SMA expanded registry is a longitudinal, prospective, observational study of patients with SMA in Canada designed to evaluate the safety and effectiveness of novel therapies and provide practical information unattainable in trials.
The consensus expanded dataset includes items that address therapy effectiveness and safety and is collected in a multicenter, prospective, observational study, including SMA patients regardless of therapeutic status. The expanded dataset is aligned with global datasets to facilitate collaboration. Additionally, consensus dataset development aimed to standardize appropriate outcome measures across the network and broader Canadian community. Prospective outcome studies, data use, and analyses are independent of the funding partner.
Prospective outcome data collected will provide results on safety and effectiveness in a post-therapy approval era. These data are essential to inform improvements in care and access to therapy for all SMA patients.
The literature on the neurobiology of emotional processing in panic disorder (PD) remains inconsistent. Clinical heterogeneity could be causing this.
To investigate differences in brain activity between PD and healthy controls using the emotional faces fMRI paradigm.
To elucidate neurobiological mechanisms underlying emotional processing in PD and previously identified subtypes (Pattyn et al., 2015).
The main analysis compared the neural processing of different emotional facial expressions from a large group of PD patients (n = 73) versus healthy controls (n = 58) originating from the Netherlands Study of Depression and Anxiety (NESDA). A second analysis divided the PD group into the three previously identified subgroups: a cognitive-autonomic (n = 22), an autonomic (n = 16) and an aspecific subgroup (n = 35). The fusiform gyrus, the anterior cingulate cortex and the insula were used in a ROI approach.
Comparing PD patients with healthy controls, a decreased activity on angry faces was observed in the left fusiform gyrus. The subgroup analysis showed more activity in the anterior cingulate cortex on neutral faces in the cognitive-autonomic subgroup versus the autonomic subgroup and a decreased activity in the left fusiform gyrus on angry faces compared to the aspecific subgroup. Less activity was observed in the right insula on neutral faces in the autonomic subgroup versus the aspecific subgroup.
Reduced activity in the left fusiform gyrus was differentiating panic disorder patients from healthy controls. In accordance with clinical subtyping, between-subtype differences are an indication that a phenomenological approach could provide more insight in underlying neurobiological mechanisms in emotional processing in PD.
Disclosure of interest
The authors have not supplied their declaration of competing interest.
The Nutrition Society's 1st Annual Nutrition and Cancer Networking Conference brought together scientists from the fields of Nutrition, Epidemiology, Public Health, Medical Oncology and Surgery with representatives of the public, cancer survivors and cancer charities. Speakers representing these different groups presented the challenges to collaboration, how the needs of patients and the public can be met, and the most promising routes for future research. The conference programme promoted debate on these issues to highlight current gaps in understanding and barriers to generating and implementing evidence-based nutrition advice. The main conclusions were that the fundamental biology of how nutrition influences the complex cancer risk profiles of diverse populations needs to be better understood. Individual and population level genetics interact with the environment over a lifespan to dictate cancer risk. Large charities and government have a role to play in diminishing our current potently obesogenic environment and exploiting nutrition to reduce cancer deaths. Understanding how best to communicate, advise and support individuals wishing to make dietary and lifestyle changes, can reduce cancer risk, enhance recovery and improve the lives of those living with and beyond cancer.
Recently, Brietzke, Silva and Sellers [‘Congruences related to an eighth order mock theta function of Gordon and McIntosh’, J. Math. Anal. Appl.479 (2019), 62–89] studied the number
of overpartitions of
into odd parts without gaps between the nonoverlined parts, whose generating function is related to the mock theta function
of order 8. In this paper we first present a short proof of the 3-dissection for the generating function of
. Then we establish three congruences for
along certain progressions which are subsequences of the integers
be the number of overpartitions in which (i) the difference between successive parts may be odd only if the larger part is overlined and (ii) if the smallest part is odd then it is overlined. Ramanujan-type congruences for
modulo small powers of
have been established. We present two infinite families of congruences modulo
, the first of which generalises a recent result of Chern and Hao [‘Congruences for two restricted overpartitions’, Proc. Math. Sci.129 (2019), Article 31].
The foetal programming hypothesis posits that optimising early life factors e.g. maternal diets can help avert the burden of adverse childhood outcomes e.g. childhood obesity. To improve applicability to public health messaging, we investigated whether maternal whole diet quality and inflammatory potential influence childhood adiposity in a large consortium.
We harmonized and pooled individual participant data from up to 8,769 mother-child pairs in 7 European mother-offspring cohorts. Maternal early-, late-, and whole-pregnancy dietary quality and inflammatory potential were assessed with Dietary Approaches to Stop Hypertension (DASH) and energy-adjusted Dietary Inflammatory Index (E-DII), respectively. Primary outcome was childhood overweight and obesity (OWOB), defined as age- and sex-specific body-mass-index-z score (BMIz) > 85th percentile based on WHO growth standard. Secondary outcomes were sum-of-skinfold-thickness (SST), fat-mass-index (FMI) and fat-free-mass-index (FFMI) in available cohorts. Outcomes were assessed in early- [mean (SD) age: 2.8 (0.3) y], mid- [6.2 (0.6) y], and late-childhood [10.6 (1.2) y]. We used multivariable regression analyses to assess the associations of maternal E-DII and DASH with offspring adiposity outcomes in cohort-specific analyses, with subsequent random-effects meta-analyses. Analyses were adjusted for maternal age, pre-pregnancy BMI, parity, lifestyle factors, energy intake, educational attainment, offspring age and sex.
A more pro-inflammatory maternal diet, indicated by higher E-DII, was associated with a higher risk of offspring late-childhood OWOB [pooled-OR (95% CI) comparing highest vs. lowest E-DII quartiles: 1.22 (1.01,1.47) for whole-pregnancy and 1.38 (1.05,1.83) for early-pregnancy; both P < 0.05]. Moreover, higher late-pregnancy E-DII was associated with higher mid-childhood FMI [pooled-β (95% CI): 0.11 (0.003,0.22) kg/m2; P < 0.05]; trending association was observed for whole-pregnancy E-DII [0.12 (-0.01,0.25) kg/m2; P = 0.07]. A higher maternal dietary quality, indicated by higher DASH score, showed a trending inverse association with late-childhood OWOB (pooled-OR (95% CI) comparing highest vs. lowest DASH quartiles: 0.58 (0.32,1.02; P = 0.06). Higher early-pregnancy DASH was associated with lower late-childhood SST [pooled-β (95% CI): -1.9 (-3.6,-0.1) cm; P < 0.05] and tended to be associated with lower late-childhood FMI [-0.34 (-0.71,0.04) kg/m2; P = 0.08]. Higher whole-pregnancy DASH tended to associate with lower early-childhood SST [-0.33 (-0.72,0.06) cm; P = 0.10]. Results were similar when modelling DASH and E-DII continuously.
Analysis of pooled data suggests that pro-inflammatory, low-quality maternal antenatal diets may influence offspring body composition and obesity risk, especially during mid- or late-childhood. Due to variation of data availability at each timepoint, our results should be interpreted with caution. Because most associations were observed at mid-childhood or later, future studies will benefit from a longer follow-up.
Whether mild traumatic brain injury (mTBI) sustained by children results in persistent or recurrent symptoms, over and above those experienced by children who solely sustain mild extracranial injuries, remains debated. The current prospective longitudinal case-controlled study aimed to examine the relative influence of injury and noninjury factors on symptoms in preschool and primary school-aged children who sustained an mTBI or mild extracranial injury at least 8 month earlier.
Participants were 64 parents of children (31 mTBI, 33 trauma controls) who sustained injury between ages 2 and 12, whose postconcussive symptoms across the first 3-month postinjury have been previously described. The current study assessed postconcussive symptoms at 8 or more months postinjury (M = 24.3, SD = 8.4) and examined a range of injury and noninjury predictive factors.
At or beyond 8-month postinjury, symptom numbers in the mTBI group were comparable with those of the group who sustained mild extracranial injury. Educational attainment of parents (below or above high-school attainment level) was the only predictor of symptoms at follow-up, with preexisting learning difficulties approaching significance as a predictor.
While our earlier study found that mTBI was associated with symptoms at 3-month postinjury, follow-up at more than 8 months showed mTBI no longer predicted symptom reporting. While mTBI contributes significantly to the presence of symptoms in the first few months postinjury, researchers and healthcare practitioners in this field need to consider the potential impact of noninjury factors on persistent or recurrent symptoms after mTBI.
It is difficult to separate an age-dependent fall in nitrogen use efficiency (NUE; N balance/N intake) in growing ruminants from a progressively decrease in animal protein requirements over time. This study examined the effect of dietary protein content on N partitioning, digestibility and N isotopic discrimination between the animal and its diet (Δ15Nanimal-diet) evaluated at two different fattening periods (early v. late). Twenty-four male Romane lambs (age: 19 ± 4.0 days; BW: 8.3 ± 1.39 kg) were equally allocated to three dietary CP treatments (15%, 17% and 20% CP on a DM basis). Lambs were reared with their mothers until weaning, thereafter housed in individual pens until slaughter (45 kg BW). During the post-weaning period, lambs were allocated twice (early fattening (30 days post-weaning) and late fattening (60 days post-weaning)) to metabolic cages for digestibility and N balance study. When diet CP content increased, the average daily gain of lambs increased (P < 0.05) while the age at slaughter decreased (P = 0.01), but no effect was observed on feed efficiency (P > 0.10). Diet CP content had limited effect on lamb carcass traits. Higher fibre digestibility was observed at the early v. late fattening period (P < 0.001). The N intake and the urinary N excretion increased when diet CP content increased (P < 0.001) and when shifting from early to late fattening period (P < 0.001). Faecal N excretion (P = 0.14) and N balance (P > 0.10) were not affected by diet CP content. Nitrogen digestibility increased (P < 0.001) as the diet CP content increased and on average it was greater at late v. early fattening period (P = 0.02). The NUE decreased (P = 0.001) as the diet CP content increased and as the lamb became older (P < 0.001). However, the age-dependent fall in NUE observed was lower at high v. low dietary CP content (CP × age interaction; P = 0.04). The Δ15Nanimal-diet was positively correlated (P < 0.05) with N intake (r = 0.59), excretion of faecal N (r = 0.41), urinary N (r = 0.69) and total manure N (r = 0.64), while negatively correlated with NUE (r = −0.57). Overall, the experiment showed NUE was lower in older lambs and when lambs were fed high diet CP content, and that Δ15Nanimal-diet was a useful indicator not only for NUE but also for urinary N excretion, which is a major environmental pollution factor on farm.
Though African-American and Latino electoral success in state legislative and congressional elections continues to occur almost entirely in majority-minority districts, minorities now have new opportunities in districts that are only 40–50% minority. This success can primarily be explained in terms of a curvilinear model that generates a “sweet spot” of maximum likelihood of minority candidate electoral success as a function of minority population share of the district and the proportion of the district that votes Republican. Past racial redistricting legal challenges often focused on cracking concentrated racial minorities to prevent the creation of majority-minority districts. Future lawsuits may also follow in the steps of recent successful court challenges against racially motivated packing that resulted in the reduction of minority population percentage in a previously majority-minority district in order to enhance minority opportunity in an adjacent non-majority-minority district.
Space Infrared Telescope for Cosmology and Astrophysics (SPICA), the cryogenic infrared space telescope recently pre-selected for a ‘Phase A’ concept study as one of the three remaining candidates for European Space Agency (ESA's) fifth medium class (M5) mission, is foreseen to include a far-infrared polarimetric imager [SPICA-POL, now called B-fields with BOlometers and Polarizers (B-BOP)], which would offer a unique opportunity to resolve major issues in our understanding of the nearby, cold magnetised Universe. This paper presents an overview of the main science drivers for B-BOP, including high dynamic range polarimetric imaging of the cold interstellar medium (ISM) in both our Milky Way and nearby galaxies. Thanks to a cooled telescope, B-BOP will deliver wide-field 100–350
m images of linearly polarised dust emission in Stokes Q and U with a resolution, signal-to-noise ratio, and both intensity and spatial dynamic ranges comparable to those achieved by Herschel images of the cold ISM in total intensity (Stokes I). The B-BOP 200
m images will also have a factor
30 higher resolution than Planck polarisation data. This will make B-BOP a unique tool for characterising the statistical properties of the magnetised ISM and probing the role of magnetic fields in the formation and evolution of the interstellar web of dusty molecular filaments giving birth to most stars in our Galaxy. B-BOP will also be a powerful instrument for studying the magnetism of nearby galaxies and testing Galactic dynamo models, constraining the physics of dust grain alignment, informing the problem of the interaction of cosmic rays with molecular clouds, tracing magnetic fields in the inner layers of protoplanetary disks, and monitoring accretion bursts in embedded protostars.
We generalise a result of Chern [‘A curious identity and its applications to partitions with bounded part differences’, New Zealand J. Math.47 (2017), 23–26] on distinct partitions with bounded difference between largest and smallest parts. The generalisation is proved both analytically and bijectively.