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The Division for Early Childhood (DEC) collaborates with the Early Intervention and Early Childhood Special Education (EI/ECSE) community and allied partners to create resources (such as publications like Young Exceptional Children [YEC] and The Journal of Early Intervention [JEI] and products like The DEC Recommended Practices and Learning Decks) that reflect collective expertise. These resources address field needs and support DEC's mission of guiding early intervention and special education services for infants, toddlers, and preschoolers with or at-risk for disabilities and their families. To advance equity, DEC members are committed to studying, discussing, and applying DEC's Racial Equity Point of View (RE POV; Division for Early Childhood [DEC], 2023) to all its resources and the system that produces them. To create transformative change within DEC's resources, this article includes reflections on how DEC's RE POV can inspire new associated practices and policies to foster a more equitable and inclusive resource system. Also included are reflective questions for readers, DEC members, and non-members alike, to build their critical consciousness related to the need to disrupt structural racism and ableism and (re)build DEC's resource system into one that prioritizes equity.

The reaction of [(3-bdppmapy)(AuCl)2] with NaHmna (3-bdppmapy = N,N’-bis-(diphenylphosphanylmethyl-3-aminopytidine, H2mna = 2-mercaptonicotinic acid)) resulted in a tetranuclear Au-P-S complex [(3-bdppmapy)2(AuHmna)2(AuCl)2] (1) which emitted bright yellow fluorescence at 542 nm under 377 nm excitation (QY = 5.3%, τ = 0.83 ns). Upon grinding, the emission intensity of 1 significantly and rapidly decreased, but could be recovered by exposure to CH2Cl2 vapor. This switchable fluorescence is attributed to the breaking and reforming of intermolecular hydrogen bonds with concomitant collapse and the restoration of the crystalline phase, which is not caused by static pressure or increased temperature.

A 66-year old woman presented to us with syncope and carpopedal spasm. The history of her condition started 10 years ago as recurrent loss of consciousness associated with carpopedal spasm occurring at 2-3 times in a year. A medical consult led to a diagnosis of hypocalcemia, and she has since been maintained on oral calcium supplementation

Objectives. To determine the diagnostic accuracy of combined ultrasound-guided fine needle aspiration biopsy (USG-FNAB) and intraoperative frozen section examinationin (FSE) in diagnosing malignant thyroid nodules. Methodology. Retrospective review of patients undergoing thyroidectomy with intraoperative frozen section examination following ultrasound guided fine-needle aspiration biopsy. Sensitivity, specificity, positive and negative predictive values and accuracy were calculated with respect to final histology. Results. A total of 2,239 nodules were subjected to USG-FNAB at the Diabetes, Thyroid and Endocrine Center, St. Luke’s Medical Center between January 2007 and December 2009. Two hundred fifty-one nodules were surgically excised following USG-FNAB. Frozen section examinations were taken from 90 of 251 nodules. The USG-FNAB yielded 90.3% (n=1,721) adequate specimens and 9.7% (n=185) inadequate specimens. The histologic examination of the 251 surgically excised nodules revealed 182 (73%) benign and 69 (27%) malignant nodules. The sensitivity, specificity, positive and negative predictive values and accuracy rate of USG-FNAB cytology are 70.3%, 92.8%, 76.5%, 90.4% and 87.2%, respectively. The diagnosis by frozen section was benign in 56 cases (62%), malignant in 10 cases (11%) and deferred in 24 cases (27%). By FSE, the sensitivity, specificity, positive and negative predictive values and accuracy rate are 83.3%, 100%, 100%, 96.4% and 96.7%, respectively. A diagnostic accuracy of up to 97.2% was achieved when USG-FNAB and FSE were combined and when their findings were concordant. When USG-FNAB and FSE diagnoses were discordant, the FSE showed superior accuracy (83.3%) than cytology (16.7%). In the group of nodules with indeterminate or inadequate cytology, the diagnostic accuracy of frozen section is 100%. Conclusion. Ultrasound guided fine-needle aspiration biopsy is an accurate preoperative test for the evaluation of nodular thyroid disease. It helps to distinguish malignant from benign lesions. The intraoperative frozen section is a valuable test for confirming the cytologic diagnosis. It is especially important in identifying malignant thyroid nodule in cases with indeterminate cytology. The combination of USG-FNAB and FSE greatly improves the accuracy rate in thyroid cancer detection.

A 56-year-old Filipino male presented with bilateral lower limb swelling. The patient was a known smoker with a one-year history of Graves’ disease. He was initially treated with methimazole for control of thyrotoxicosis. Five months prior to consultation, he was given oral radioactive iodine (Iodine-131) for the definitive treatment of his thyroid disease.

Background Data on the benefits of cardiac resynchronization therapy (CRT) in patients with severe heart failure symptoms are limited. We investigated the relative effects of CRT in patients with ambulatory New York Heart Association (NYHA) IV versus III functional class at the time of device implantation. Methods and Results In this meta‐analysis, we pooled patient‐level data from the MIRACLE (Multicenter InSync Randomized Clinical Evaluation), MIRACLE‐ICD (Multicenter InSync Implantable Cardioversion Defibrillation Randomized Clinical Evaluation), and COMPANION (Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure) trials. Outcomes evaluated were time to the composite end point of the first heart failure hospitalization or all‐cause mortality, and time to all‐cause mortality alone. The association between CRT and outcomes was evaluated using a Bayesian hierarchical Weibull survival regression model. We assessed if this association differed between NYHA III and IV groups by adding an interaction term between CRT and NYHA class as a random effect. A sensitivity analysis was performed by including data from RAFT (Resynchronization‐Defibrillation for Ambulatory Heart Failure). Our pooled analysis included 2309 patients. Overall, CRT was associated with a longer time to heart failure hospitalization or all‐cause mortality (adjusted hazard ratio [aHR], 0.79 [95% credible interval [CI], 0.64–0.99]; posterior probability or P=0.044), with a similar association with time to all‐cause mortality (aHR, 0.78 [95% CI, 0.59–1.03]; P=0.083). Associations of CRT with outcomes were not significantly different for those in NYHA III and IV classes (ratio of aHR, 0.72 [95% CI, 0.30–1.27]; P=0.23 for heart failure hospitalization/mortality; ratio of aHR, 0.70 [95% CI, 0.35–1.34]; P=0.27 for all‐cause mortality alone). The sensitivity analysis, including RAFT data, did not show a significant relative CRT benefit between NYHA III and IV classes. Conclusions Overall, there was no significant difference in the association of CRT with either outcome for patients in NYHA functional class III compared with functional class IV.

Background Global policy to guide action on musculoskeletal (MSK) health is in a nascent phase. Lagging behind other non-communicable diseases (NCDs) there is currently little global policy to assist governments to develop national approaches to MSK health. Considering the importance of comparison and learning for global policy development, we aimed to perform a comparative analysis of national MSK policies to identify areas of innovation and draw common themes and principles that could guide MSK health policy.Methods Multi-modal search strategy incorporating a systematic online search targeted at the 30 most populated nations; a call to networked experts; a specified question in a related eDelphi questionnaire; and snowballing methods. Extracted data were organised using an a priori framework adapted from the World Health Organization (WHO) Building Blocks and further inductive coding. Subsequently, texts were open coded and thematically analysed to derive specific sub-themes and principles underlying texts within each theme, serving as abstracted, transferable concepts for future global policy.Results The search yielded 165 documents with 41 retained after removal of duplicates and exclusions. Only three documents were comprehensive national strategies addressing MSK health. The most common conditions addressed in the documents were pain (non-cancer), low back pain, occupational health, inflammatory conditions, and osteoarthritis. Across eight categories, we derived 47 sub-themes with transferable principles that could guide global policy for: service delivery; workforce; medicines and technologies; financing; data and information systems; leadership and governance; citizens, consumers and communities; and research and innovation.Conclusion There are few examples of national strategic policy to address MSK health; however, many countries are moving towards this by documenting the burden of disease and developing policies for MSK services. This review found a breadth of principles that can add to this existing work and may be adopted to develop comprehensive system-wide MSK health approaches at national and global levels.

Abstract Background This study investigated healthcare access and quality for people who are transgender and gender‐diverse (PTGD) in Saskatchewan (SK), Canada, to inform a larger project that was piloting two peer health navigators for PTGD. Methods Two online focus groups were held. Nineteen participants were recruited to represent a broad range in age, gender and location in SK. Transcripts of the focus groups were analyzed using a thematic approach. Results The core theme that was identified was participants' desire for culturally safe healthcare. This core theme had two component themes: (1) systemic healthcare factors and (2) individual healthcare provider (HCP) factors. The healthcare system primarily acted as a barrier to culturally safe healthcare. HCPs could be either barriers or facilitators of culturally safe care; however, negative experiences outweighed positive ones. Conclusions PTGD in SK face discrimination, with delays and barriers to care at all levels of the healthcare system. Peer health navigators can address some of these discrepancies; however, greater support is required for PTGD to be able to access culturally safe healthcare. Patient or Public Contribution People with lived experience/PTGD were involved in all stages of this project. They were included on the team as community researchers and co‐developed the research project, conducted the focus groups, participated in the analyses and are co‐authors. As well, both navigators and all the participants in the focus groups were also PTGD.

Abstract Background In 2018, the Community-Based Research Centre (CBRC) invited gay, bisexual, trans, queer men and Two-Spirit and non-binary people (GBT2Q) at Pride Festivals across Canada to complete in-person Sex Now surveys and provide optional dried blood spot (DBS) samples screening for human immunodeficiency virus (HIV) and hepatitis C virus (HCV). As there is a lack of research evaluating the implementation of DBS sampling for GBT2Q in community settings, we aimed to evaluate this intervention, identifying key facilitators and ongoing challenges to implementing community-based DBS screening for HIV/HCV among GBT2Q. Methods We conducted sixteen one-on-one interviews with individuals involved with the community-based DBS collection protocol, including research staff, site coordinators, and volunteer DBS collectors. Most individuals involved with DBS collection were “peers” (GBT2Q-identified). The Consolidated Framework for Implementation Research (CFIR) guided our data collection and analysis. Results Interviewees felt that DBS collection was a low-barrier, cost-effective, and simple way for peers to quickly screen a large number of Sex Now respondents. Interviewees also noted that the community and peer-based aspects of the research helped drive recruitment of Sex Now respondents. Most interviewees felt that the provision of results took too long, and that some Sex Now respondents would have preferred to receive their test results immediately (e.g., rapid or point-of-care testing). Conclusion Peer-based DBS sampling can be an effective and relatively simple way to screen GBT2Q at Pride Festivals for more than one sexually transmitted and blood borne infection.

Abstract Background and Aims The COVID‐19 pandemic has made an outsized negative impact on mental health worldwide. However, research indicates that this impact was not uniform. This study aimed to determine how mental health patients experienced the COVID‐19 pandemic to characterize mental health disparities and identify underlying factors. Methods We used the Epidemic‐Pandemic Impacts Inventory (EPII) and latent class analysis to determine the impacts of epidemics and pandemics across several life domains in 245 survey respondents, all of whom were mental health patients at Siyan Clinical. Respondents were predominately White (84.5%) and female (76.3%), with the majority being diagnosed with anxiety or mood disorders (76.3%). Results In the work life domain, respondents in the higher‐impact class were more likely to be employed and/or working in healthcare. In both the home life and emotional/physical health and infection domain, respondents with mood disorders, substance use disorders, or children under 18 living at home were more likely to be in the higher‐impact class. In the home life and positive change domains, respondents that were married were more likely to be in the higher‐impact class, indicating that this group experiences more impacts from the pandemic, both positive and negative. Finally, some groups stood out as having fewer impacts from the pandemic: respondents that were male, over age 55, White, and/or have anxiety disorders were more likely to experience fewer impacts from the pandemic in the work life and home life domains. Conclusions This study provides evidence that certain groups may experience greater or fewer impacts from the pandemic.

To evaluate the efficiency of the oil-reducing properties of kombucha cellulose, enzymolysis and microwave-assisted enzymolysis methods were developed. The water-holding capacity of the kombucha cellulose hydrolysates formed by these two methods was higher than for the intact kombucha cellulose, while the oil-holding capacity was lower. The hydrolysates of kombucha cellulose and the intact kombucha cellulose were used to make deep-fried donuts. During this process, kombucha cellulose hydrolysates were added instead of 2% flour, and from the results, the oil content of the donut decreased significantly from ~28 to 15%, and the reduction was not related to the processing of the donut. The hardness and brittleness of all samples showed no significant change, and these samples had similar internal micro-structures, confirming texture profile analysis. In vitro digestion results suggested that there would be no adverse health effects from substituting kombucha cellulose hydrolysates in the deep-fried donut formula.

The reaction of CF3COOAg, 3-bdppmapy (N,N-bis(diphenylphosphanylmethyl)-3-aminopyridine) and HTZ (1,2,4-triazole-3-thiol) in CH2Cl2/MeOH resulted in a dinuclear Ag/P/S complex [Ag2(TZ)2(3-bdppmapy)2]·xSol (1·xSol). Crystals of 1·xSol converted to 1·2MeOH in air at room temperature and further to 1 under vacuum upon heating. The solid-state, room-temperature photoluminescent emission of 1·xSol (510 nm) shifted to 494 nm (1·2MeOH) and 486 nm (1). Grinding solids of 1·2MeOH in air resulted in amorphous 1G characterized by solid-state emission at 468 nm, which converted to 1GR with 513 nm emission upon MeOH treatment. Grinding 1GR in air returned 1G, and this interconversion was reproducible over five cycles. The solid-state photoluminescence of 1G changed in response to vapors containing low–molecular weight alcohols but remained unchanged after exposure to other volatile organic compounds (VOCs) or to water vapor. Test papers impregnated with 1G could detect methanol in vapors from aqueous solutions at concentrations above 50%. Complex 1G is, therefore, an example of a stimuli-responsive molecular sensor for the detection of alcohols.

The application of photo responsive crystals to useful actuation demands a rational design to elicit controllable movement. The [2+2] photocycloaddition reaction triggers mechanical motion using associated photosalient (PS) effects. We herein report a coordination site selective occupation strategy to modulate the arrangement of C=C bonds and thereby tune the PS effect. Replacing or repositioning the donor atom at one end of the linear ligand allowed for a greater level of molecular structural flexibility, facilitating [2+2] photocycloaddition. The distance between photoreactive centres and coordination sites was adjusted by ligand design to regulate PS behaviour. This work suggests new avenues for modulating PS movement to achieve useful motion. [ABSTRACT FROM AUTHOR]

Lychee pulp phenolics (LPP) is mainly catabolized in the host colon, increasing the abundances of Bacteroides and Lactobacillus. Herein, five selected gut microbial strains (Bacteroides uniformis, B. thetaiotaomicron, Lactobacillus rhamnosus, L. plantarum, and L. acidophilus) were separately incubated with LPP to ascertain the specific strains participating in phenolic metabolism and the corresponding metabolites. The results indicated that B. uniformis, L. rhamnosus, and L. plantarum were involved in LPP utilization, contributing to 52.37, 28.33, and 45.11% of LPP degradation after 48 h fermentation, respectively. Unprecedentedly, the metabolic pathway of the major phenolic compound quercetin-3-O-rutinose-7-O-α-L-rhamnoside by L. plantarum, appeared to be the direct fission of C-ring at C2–O1 and C3–C4 bonds, which was proved from the occurrence of two substances with the deprotonated molecule [M–H]− ion at m/z 299 and 459, respectively. Meanwhile, it was fully confirmed that B. uniformis participated in the catabolism of isorhamnetin glycoside and procyanidin B2. In the B. uniformis culture, kaempferol was synthesized through dehydroxylation of quercetin which could be catabolized into alphitonin by L. rhamnosus. Furthermore, LPP metabolites exerted higher antioxidant activity than their precursors and gave clues to understand the interindividual differences for phenolic metabolism by gut microbiota.

Coordination polymers of transition metal ions are fascinating and important to coordination chemistry. One of the ligands known to form particularly interesting coordination polymers is 3,3′,5,5′-tetramethyl-4,4′-bipyrazole (Me4bpzH2). Group 11 metal(I) ion coordination polymers, other than those of copper(I), are relatively easy to handle because of their low reactivity towards dioxygen and moisture. However, the known silver(I) coordination polymers often have poor solubility in common solvents and so cannot be easily analyzed in solution. By using a tetramethyl substituted bipyrazole ligand, we have synthesized more soluble silver(I) complexes that contain the trifluoromethyl group in the coordinated ions CF3CO2− and CF3SO3− in [Ag(CF3CO2)(Me4bpzH2)] and [Ag(CF3SO3)(Me4bpzH2)]. We determined both structures by single-crystal X-ray analysis at low temperatures and compared them in detail. Moreover, we investigated the solution behavior of these coordination polymers by 1H-NMR, IR, Raman, UV–Vis spectroscopies, and their low-temperature, solid-state photoluminescence. The high-energy band at ~330 nm corresponded to ligand-centered (bipyrazole) fluorescence, and the low-energy band at ~400 nm to ligand-centered phosphorescence resulting from the heavy atom effect.

The delivery of biocompatible reagents into cancer cells can elicit an anticancer effect by taking advantage of the unique characteristics of the tumor microenvironment (TME). In this work, we report that nanoscale two-dimensional FeII- and CoII-based metal–organic frameworks (NMOFs) of porphyrin ligand meso-tetrakis (6-(hydroxymethyl) pyridin-3-yl) porphyrin (THPP) can catalyze the generation of hydroxyl radicals (•OH) and O2 in the presence of H2O2 that is overexpressed in the TME. Photodynamic therapy consumes the generated O2 to produce a singlet oxygen (1O2). Both •OH and 1O2 are reactive oxygen species (ROS) that inhibit cancer cell proliferation. The FeII- and CoII-based NMOFs were non-toxic in the dark but cytotoxic when irradiated with 660 nm light. This preliminary work points to the potential of porphyrin-based ligands of transition metals as anticancer drugs by synergizing different therapeutic modalities.

A new Ag/Cu bimetallic cluster [Ag10Cu6(bdppthi)2(C≡CPh)12(EtOH)2](ClO4)4 (1, bdppthi = N,N′-bis(diphenylphosphanylmethyl)-tetrahydroimidazole) exhibited strong phosphorescent (PL) emission at 644 nm upon excitation at 400 nm. Removal of the coordinated EtOH molecules in 1 resulted in derivative 1a, which exhibited significant red-shifted emission at 678 nm. The structure and PL of 1 was restored on exposure to EtOH vapor. Cluster 1a also exhibited a vapor-chromic PL response towards other common organic solvent vapors including acetone, MeOH and MeCN. A PMMA film of 1a was developed as a reusable visible sensor for MeCN.

While the etiology of hippocampal sclerosis (HS) in epilepsy patients remains unknown, distinct phenotypes of hippocampal subfield atrophy have been associated with different clinical presentations and surgical outcomes. The advent of novel techniques including ultra-high field 7T magnetic resonance imaging (MRI) and automated subfield volumetry have further enabled detection of hippocampal pathology in patients with epilepsy, however, studies combining both 7T MRI and automated segmentation in epilepsy patients with normal-appearing clinical MRI are limited. In this study, we present a novel application of the automated segmentation of hippocampal subfields (ASHS) software to determine subfield volumes of the CA1, CA2/3, CA4/DG, and the subiculum using ultra high-field 7T MRI scans, including T1-weighted MP2RAGE and T2-TSE sequences, in 27 patients with either mesial temporal lobe epilepsy (mTLE) or neocortical epilepsy (NE) compared to age and gender matched healthy controls. We found that 7T improved visualization of structural abnormalities not otherwise seen on clinical strength MRIs in patients with unilateral mTLE. Additionally, our automated segmentation algorithm was able to detect structural differences in volume and asymmetry across hippocampal subfields in unilateral mTLE patients compared to controls. Specifically, amongst unilateral mTLE patients with longer disease durations, volume loss was observed in the ipsilateral CA1 and CA2/3 subfields and contralateral CA1. There were no differences in subfield volumes in patients with NE compared to controls. We report the first application of 7T with automated segmentation to characterize the relationship between disease duration burden and asymmetry across specific hippocampal subfields in this population. Disease duration was found to have a statistically significant positive relationship with subfield asymmetry within the unilateral mTLE cohort. These findings highlight the ability of 7T MRI and automated segmentation to provide novel qualitative and quantitative information in epilepsy patients who are otherwise MRI-negative at clinical field strengths.

Abstract Background The detection of prostate cancer requires histological confirmation in biopsy core. Currently, number of unnecessary prostate biopsies are being performed in the United States. This is due to the absence of appropriate biopsy decision‐making protocol. Aim To develop and validate a 4K score/multiparametric magnetic resonance imaging (mpMRI)‐based nomogram to predict prostate cancer (PCa), clinically significant prostate cancer (csPCa), and unfavorable prostate cancer (uPCa). Methods and Results Retrospective, single‐center study evaluating a cohort of 574 men with 4K score test >7% or suspicious digital rectal examination (DRE) or Prostate Imaging Reporting and Data System (PI‐RADS) scores 3, 4, or 5 on mpMRI that underwent systematic and/or mpMRI/ultrasound fusion–targeted prostate biopsy between 2016 and 2020. External cohort included 622 men. csPCa and uPCa were defined as Gleason score ≥3 + 4 and ≥4 + 3 on biopsy, respectively. Multivariable logistic regression analysis was performed to build nomogram for predicting PCa, csPCa, and uPCa. Validation was performed by plotting the area under the curve (AUC) and comparing nomogram‐predicted probabilities with actual rates of PCa, csPCa, and uPCa probabilities in the external cohort. 4K score, a PI‐RADS ≥4, prostate volume and prior negative biopsy were significant predictors of PCa, csPCa, and uPCa. AUCs were 0.84, 0.88, and 0.86 for the prediction of PCa, csPCa, and uPCa, respectively. The predicted and actual rates of PCa, csPCa, and uPCa showed agreement across all percentage probability ranges in the validation cohort. Using the prediction model at threshold of 30, 30% of overall biopsies, 41% of benign biopsies, and 19% of diagnosed indolent PCa could be avoided, while missing 9% of csPCa. Conclusion This novel nomogram would reduce unnecessary prostate biopsies and decrease detection of clinically insignificant PCa.

BackgroundRecent research has shown that the impacts of the COVID-19 pandemic and social isolation on people’s mental health are quite extensive, but there are limited studies on the effects of the pandemic on patients with mental health disorders. ObjectiveThe objective of this study was to assess the negative impacts of the COVID-19 pandemic on individuals who have previously sought treatment for a mental health disorder. MethodsThis study uses the newly developed Epidemic-Pandemic Impacts Inventory (EPII) survey. This tool was designed to assess tangible impacts of epidemics and pandemics across personal and social life domains. From November 9, 2020, to February 18, 2021, a total of 245 adults recruited from a mental health clinic completed the consent form and responded to the survey link from the Siyan Clinical Corporation and Siyan Clinical Research practices located in Santa Rosa, California, USA. ResultsWe found that the least affected age group included individuals aged 75 years or older. This was followed closely by the 65- to 75-year-old age group. People with children under the age of 18 years also reported both more negative indicators associated with the pandemic and more positive indicators compared to those without children at home. Gender queer, nonconforming, and transgender individuals may also be at higher risk for more negative impacts associated with the pandemic. When respondents were assessed with regard to their mental health diagnosis, no differences were noted. Substance use also increased during the pandemic. ConclusionsIn conclusion, the data collected here may serve as foundational research in the prevention, care, and treatment of mental health disorders during pandemics such as COVID-19. Populations such as those with previously diagnosed mental health disorders are particularly at risk for negative effects of pandemic-related stressors such as social isolation, especially if they have children in the household, are part of a younger age group, or have substance use disorder. Gender may also be a factor. Further, the EPII survey may prove to be a useful tool in understanding these effects. Overall, these data may be a critical step toward understanding the effects of the COVID-19 pandemic on populations with a mental health diagnosis, which may aid mental health practitioners in understanding the consequences of pandemics on their patients’ overall well-being. Trial RegistrationClinicalTrials.gov NCT04568135; https://clinicaltrials.gov/ct2/show/NCT04568135

Background: Cytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients. Methods: In this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who received ≥1 dose of ASP0113/placebo. The primary efficacy endpoint was the proportion of allo-HCT recipients with composite all-cause mortality and adjudicated CMV end-organ disease (EOD) by 1 year post-transplant. ClinicalTrials.gov: NCT01877655 (not recruiting). Findings: Patients were recruited between Sept 11, 2013 and Sept 21, 2016. Overall, 501 patients received ≥1 dose of ASP0113 (n = 246) or placebo (n = 255). The proportion of patients with composite all-cause mortality and adjudicated CMV EOD by 1 year post-transplant was 35.4% (n = 87) with ASP0113 and 30•2% (n = 77) with placebo (odds ratio 1.27; 95% confidence interval: 0.87 to 1.85; p = 0.205). Incidence of injection site-related treatment-emergent adverse events (TEAEs) was higher with ASP0113 than placebo. Overall incidence and severity of other TEAEs was similar between groups. T-cell response to pp65 increased over time and was greater with placebo than ASP0113 (p = 0.027). Interpretation: ASP0113 did not reduce overall mortality or CMV EOD by 1 year post-transplant. Safety findings were similar between groups. Funding: Astellas Pharma Global Development, Inc .

Cyclic trinuclear complexes with group 11 metal(I) ions are fascinating and important to coordination chemistry. One of the ligands known to form these cyclic trinuclear complexes is pyrazolate, which is a bridging ligand that coordinates many transition metal ions in a Npz–M–Npz linear mode (Npz = pyrazolyl nitrogen atom). In these group 11 metal(I) ions, copper is the most abundant metal. Therefore, polynuclear copper(I) complexes are very important in this field. The cyclic trinuclear copper(I) complex [Cu(3,5-Ph2pz)]3 (3,5-Ph2pz– = 3,5-diphenyl-1-pyrazolate anion) was reported in 1988 as a landmark complex, but its photoluminescence properties have hitherto not been described. In this study, we report the photoluminescence and two different polymorphs of [Cu(3,5-Ph2pz)]3 and its derivative [Cu(3-Me-5-Phpz)]3 (3-Me-5-Phpz– = 3-metyl-5-phenyl-1-pyrazale anion). The substituents in [Cu(3-Me-5-Phpz)]3 cause smaller distortions in the solid-state structure and a red-shift in photoluminescence due to the presence of intermolecular cuprophilic interactions.