Lasofoxifene versus fulvestrant for ER+/HER2- metastatic breast cancer with an ESR1 mutation: results from the randomized, phase II ELAINE 1 trial.

BACKGROUND: Acquired estrogen receptor alpha (ER/ESR1) mutations commonly cause endocrine resistance in ER+ metastatic breast cancer (mBC). Lasofoxifene, a novel selective ER modulator, stabilizes an antagonist conformation of wild-type and ESR1-mutated ER-ligand binding domains, and has antitumor activity in ESR1-mutated xenografts. PATIENTS AND METHODS: In this open-label, randomized, phase II, multicenter, ELAINE 1 study (NCT03781063), we randomized women with ESR1-mutated, ER+/human epidermal growth factor receptor 2 negative (HER2-) mBC that had progressed on an aromatase inhibitor (AI) plus a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) to oral lasofoxifene 5 mg daily or IM fulvestrant 500 mg (days 1, 15, and 29, and then every 4 weeks) until disease progression/toxicity. The primary endpoint was progression-free survival (PFS); secondary endpoints were safety/tolerability. RESULTS: A total of 103 patients received lasofoxifene (n = 52) or fulvestrant (n = 51). The most current efficacy analysis showed that lasofoxifene did not significantly prolong median PFS compared with fulvestrant: 24.2 weeks (∼5.6 months) versus 16.2 weeks (∼3.7 months; P = 0.138); hazard ratio 0.699 (95% confidence interval 0.434-1.125). However, PFS and other clinical endpoints numerically favored lasofoxifene: clinical benefit rate (36.5% versus 21.6%; P = 0.117), objective response rate [13.2% (including a complete response in one lasofoxifene-treated patient) versus 2.9%; P = 0.124], and 6-month (53.4% versus 37.9%) and 12-month (30.7% versus 14.1%) PFS rates. Most common treatment-emergent adverse events with lasofoxifene were nausea, fatigue, arthralgia, and hot flushes. One death occurred in the fulvestrant arm. Circulating tumor DNA ESR1 mutant allele fraction (MAF) decreased from baseline to week 8 in 82.9% of evaluable lasofoxifene-treated versus 61.5% of fulvestrant-treated patients. CONCLUSIONS: Lasofoxifene demonstrated encouraging antitumor activity versus fulvestrant and was well tolerated in patients with ESR1-mutated, endocrine-resistant mBC following progression on AI plus CDK4/6i. Consistent with target engagement, lasofoxifene reduced ESR1 MAF, and to a greater extent than fulvestrant. Lasofoxifene may be a promising targeted treatment for patients with ESR1-mutated mBC and warrants further investigation.

Implementing an electronic sideband offset lock for isotope shift spectroscopy in radium.

We demonstrate laser frequency stabilization with at least 6 GHz of offset tunability using an in-phase/quadrature (IQ) modulator to generate electronic sidebands (ESB) on a titanium sapphire laser at 714 nm and we apply this technique to perform isotope shift spectroscopy of 226Ra and 225Ra. By locking the laser to a single resonance of a high finesse optical cavity and adjusting the lock offset, we determine the frequency difference between the magneto-optical trap (MOT) transitions in the two isotopes to be 2630.0 ± 0.3 MHz, a factor of 29 more precise than the previously available data. Using the known value of the hyperfine splitting of the 3P1 level, we calculate the isotope shift for the 1S0 to 3P1 transition to be 2267.0 ± 2.2 MHz, a factor of 8 more precise than the best available value. Our technique could be applied to countless other atomic systems to provide unprecedented precision in isotope shift spectroscopy and other relative frequency comparisons.

Impact of 10-Day Fulbright Specialist Program and Project Pink Blue Education Sessions on Medical Oncology Knowledge Among Physicians Who Treat Cancer in Nigeria.

Despite an estimated population of over 201 million and over 115,950 yearly diagnosed new cases of cancer, Nigeria does not have dedicated medical oncologists. Most oncology care is delivered through surgical and clinical oncologists, who are trained in both radiation and medical oncology and they number fewer than 50 in the country. With a limited number of oncology professionals, cancer patients in Nigeria experience poor health outcomes, with an estimated cancer mortality rate of 75,000 deaths per year. Participants from 15 Nigerian states were selected to attend the medical oncology training. Through the support of Fulbright Specialist Program and Project PINK BLUE, two of the authors delivered 10 days of lectures based on ASCO, ESMO, and NCCN guidelines. Mean scores of both the pre- and post-course tests as well as a 1-year follow-up test were compared using GraphPad Prism 7.0a by paired t-tests. Forty-four clinical oncologists were selected for participation. Twenty-five (57%) completed the pre- and post-course tests. Of the 25 that completed both tests, percentage of correct answers increased from 45 to 59% (2-sided p-value < 0.0001). Improvements were seen in attending doctors 45 to 59% (p = 0.0046) and resident doctors 45 to 59% (0.0007). Eleven doctors responded to the 1-year follow-up test. Although not statistically significant, a numerical pattern for the benefits was maintained 1 year after the program (45% pre-course versus 52% post-course correct answers, Fisher's exact, p = 0.4185). In the short term, the training improved medical oncology knowledge in Nigeria, regardless of the participant's carrier stage. Long-term benefits were not sustained in a small sample of participants, and continuing education strategies are necessary. Similar models may be employed across Africa.

ß-Nuclear-Recoil Correlation from

We report the first precise measurement of a ß-recoil correlation from a radioactive noble gas (^{6}He) confined via a magneto-optical trap. The measurement is motivated by the search for exotic tensor-type contributions to the charged weak current. Interpreted as tensor currents with right-handed neutrinos, the measurements yield |C_{T}/C_{A}|^{2}≤0.022 (90% confidence limit, C.L.). On the other hand, for left-handed neutrinos the limits are 0.007

Correction: Exome sequencing of Pakistani consanguineous families identifies 30 novel candidate genes for recessive intellectual disability.

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Guidelines for the use of the Attend Anywhere Platform for Telecommunications within the Pain Service.

Introduction Remote consultation is of growing in importance and gaining popularity in both primary and secondary healthcare settings. Reduced necessity for a physical presence of the patient within the healthcare setting is of particular benefit in the current COVID-19 era. It is also of benefit to a diverse group of patients, for example: those who are geographically distant from the base hospital, those suffering from mobility issues or chronic illness, those who require chaperoning as well as those with limited access to transport. We have developed guidelines for the use of the medical telecommunications platform, Attend Anywhere, which has been utilised across the English and Scottish National Health Services, as well as with the Australian Health service, and is now available in Health Service Executive (HSE) settings. Herein we describe and recommend a process that we have found helpful, and we propose guidelines on how a Health Care Worker (HCW) might consider approaching a virtual consultation when initiating and safely executing a patient encounter on Attend Anywhere, in a secure and efficient manner. The guidelines were created following review of the literature on previous experience by others with this software, as well as recent guidance published by the Irish Medical Council. A proportion of this guidance is transferable to other platforms. Methods We also undertook a short survey of our patients and physicians in Sligo University Hospital, who used Attend Anywhere over a six-week period to gauge their satisfaction levels with the experience., We estimated distance that our patients would have travelled for their appointment had the traditional face-to-face consultation been carried out. We noted whether we considered the medium appropriate for the patient consultations. Results 53 patients took part and satisfaction was rated from satisfied to very satisfied on a 3-point scale for all stakeholders. In addition, we found that remote consultation, when compared to face-to-face consultation, alleviated an average of 144km of unnecessary travel per appointment. Remote consultation was deemed appropriate in all cases and no rescheduled face-to-face appointments were required due to failure of the consultation due to difficulties encountered. Conclusion The authors recommend the implementation of the described guidance, with suggested Checklist, Information leaflet and Consent form, as a means of ensuring the confidentiality of the consultation and to ensure that processes are adhered to that optimise protection for both the patient and the clinician, while reducing the burden of attendance to the healthcare location.

Guidance to improve the effectiveness of process safety management systems in operating facilities.

The Process Safety Management (PSM) systems at the operating facilities in the Oil & Gas and in Chemical manufacturing industries have matured over the years and have become, at most facilities, very robust and sophisticated. These programs are administrated by Process Safety (PS) teams at both the corporate business units and plant levels and have been effective in reducing the number and severity of PS events across the industries over the past 25 years or so. Incidents however are occurring at a regular interval and in recent times several noteworthy PS events have occurred in the United States which have brought into question the effectiveness of the PSM programs at play. These facilities have been applying their PSM programs with the expectation that the number and severity of PS events would decrease over time. The expected result has not been realized, especially in context to those facilities that have undergone the recent incidents. Current paper reviews a few publicly available PS performance reports of Oil & Gas and Chemical manufacturing industries. The authors identified a few factors at play that have led to these PS events based on their experience, literature review, and incident investigation reports. Most of the factors are intertwined with multiple PSM elements and it requires a holistic approach to address them. Each of the factors is described and the path forward is proposed to improve the effectiveness of PSM programs.

An investigation of the effects of procalcitonin testing on antimicrobial prescribing in respiratory tract infections in an Irish university hospital setting: a feasibility study.

BACKGROUND: Diagnostic uncertainty and a high prevalence of viral infections present unique challenges for antimicrobial prescribing for respiratory tract infections (RTIs). Procalcitonin (PCT) has been shown to support prescribing decisions and reduce antimicrobial use safely in patients with RTIs, but recent study results have been variable. METHODS: We conducted a feasibility study of the introduction of PCT testing in patients admitted to hospital with a lower RTI to determine if PCT testing is an effective and worthwhile intervention to introduce to support the existing antimicrobial stewardship (AMS) programme and safely decrease antimicrobial prescribing in patients admitted with RTIs. RESULTS: A total of 79 patients were randomized to the intervention PCT-guided treatment group and 40 patients to the standard care respiratory control group. The addition of PCT testing led to a significant decrease in duration of antimicrobial prescriptions (mean 6.8 versus 8.9 days, P = 0.012) and decreased length of hospital stay (median 7 versus 8 days, P = 0.009) between the PCT and respiratory control group. PCT did not demonstrate a significant reduction in antimicrobial consumption when measured as DDDs and days of therapy. CONCLUSIONS: PCT testing had a positive effect on antimicrobial prescribing during this feasibility study. The successful implementation of PCT testing in a randomized controlled trial requires an ongoing comprehensive education programme, greater integration into the AMS programme and delivery of PCT results in a timely manner. This feasibility study has shown that a larger randomized controlled trial would be beneficial to further explore the positive aspects of these findings.

YouTube™ as a source of information for patients undergoing laryngectomy: a thematic analysis.

PURPOSE: Total laryngectomy and end tracheal stoma formation are often required to treat advanced laryngeal cancer. Resources on the internet are commonly accessed by patients as a source of healthcare information. YouTube™, the most popular video-hosting website, is one such resource. The aims of this study were to assess the thematic content of the most viewed YouTube™ videos concerning laryngectomy for laryngeal cancer and to evaluate user response to these videos. METHOD: A search of YouTube™ was performed and data were extracted from videos with > 100 views. Upload source, number of views, likes, dislikes and comments were collected and the content of comments was analysed. User response was compared between upload sources using Kruskal-Wallis testing. Inductive thematic analysis of video content was performed to identify overarching themes and subthemes. RESULTS: A total of 96 videos were identified, 16 uploaded by patients, 24 by individual healthcare professionals and 56 by professional healthcare institutions. There were 1214,503 views and no significant differences in the number of views, likes or dislikes between upload sources. Three overarching themes and 17 subthemes were identified. Comments were most frequently characterised as offering praise. CONCLUSION: YouTube™ has been shown to be a popular platform for sharing information about laryngectomy for laryngeal cancer. There is a lack of data concerning the quality of this information, however, and future work should focus on assessing this. Trusted institutions could make use of this medium to disseminate high-quality information to their patients, and to the wider public.

Exome sequencing of Pakistani consanguineous families identifies 30 novel candidate genes for recessive intellectual disability.

Intellectual disability (ID) is a clinically and genetically heterogeneous disorder, affecting 1-3% of the general population. Although research into the genetic causes of ID has recently gained momentum, identification of pathogenic mutations that cause autosomal recessive ID (ARID) has lagged behind, predominantly due to non-availability of sizeable families. Here we present the results of exome sequencing in 121 large consanguineous Pakistani ID families. In 60 families, we identified homozygous or compound heterozygous DNA variants in a single gene, 30 affecting reported ID genes and 30 affecting novel candidate ID genes. Potential pathogenicity of these alleles was supported by co-segregation with the phenotype, low frequency in control populations and the application of stringent bioinformatics analyses. In another eight families segregation of multiple pathogenic variants was observed, affecting 19 genes that were either known or are novel candidates for ID. Transcriptome profiles of normal human brain tissues showed that the novel candidate ID genes formed a network significantly enriched for transcriptional co-expression (P<0.0001) in the frontal cortex during fetal development and in the temporal-parietal and sub-cortex during infancy through adulthood. In addition, proteins encoded by 12 novel ID genes directly interact with previously reported ID proteins in six known pathways essential for cognitive function (P<0.0001). These results suggest that disruptions of temporal parietal and sub-cortical neurogenesis during infancy are critical to the pathophysiology of ID. These findings further expand the existing repertoire of genes involved in ARID, and provide new insights into the molecular mechanisms and the transcriptome map of ID.

Follow-up interval for small untreated pulmonary arteriovenous malformations in hereditary haemorrhagic telangiectasia.

AIM: To investigate the natural history of untreated small (<3 mm) and microscopic pulmonary arteriovenous malformations (PAVMs) in hereditary haemorrhagic telangiectasia (HHT) in order to discern the optimal frequency of follow-up thoracic computed tomography (CT). MATERIALS AND METHODS: A retrospective analysis was performed on the follow-up data for definite and suspected HHT patients with untreated PAVMs. RESULTS: For small PAVMs in definite HHT (n=13), PAVM enlargement was identified in one patient (1/13, 7.7%) after 10.7 years follow-up and was successfully treated using transcatheter embolisation (TCE). For microscopic PAVMs in definite HHT (n=28), two patients (2/28, 7%) developed small asymptomatic PAVMs, which did not meet the size criteria for TCE after 6.8 years of follow-up. For small PAVMs in suspected HHT (n=5), feeding artery enlargement was seen in one patient (1/5, 20%) after 7.9 years, but again, this did not meet the size criteria for embolisation. No macroscopic PAVM development was identified after a median follow-up of 5.4 years in suspected HHT with microscopic PAVMs (n=20). CONCLUSION: For small and microscopic PAVMs in HHT, PAVM enlargement was found to be more infrequent than would be expected based on current guidelines; therefore, potentially challenging the current surveillance imaging recommendation of a repeat thoracic CT every 5 years.

Measurement of pH, exudate composition and temperature in wound healing: a systematic review.

OBJECTIVE: To assess the potential of measurements of pH, exudate composition and temperature in wounds to predict healing outcomes and to identify the methods that are employed to measure them. METHOD: A systematic review based on the outcomes of a search strategy of quantitative primary research published in the English language was conducted. Inclusion criteria limited studies to those involving in vivo and human participants with an existing or intentionally provoked wound, defined as 'a break in the epithelial integrity of the skin', and excluded in vitro and animal studies. Data synthesis and analysis was performed using structured narrative summaries of each included study arranged by concept, pH, exudate composition and temperature. The Evidence Based Literature (EBL) Critical Appraisal Checklist was implemented to appraise the quality of the included studies. RESULTS: A total of 23 studies, three for pH (mean quality score 54.48%), 12 for exudate composition (mean quality score 46.54%) and eight for temperature (mean quality score 36.66%), were assessed as eligible for inclusion in this review. Findings suggest that reduced pH levels in wounds, from alkaline towards acidic, are associated with improvements in wound condition. Metalloproteinase-9 (MMP-9), matrix metalloproteinase-2 (MMP-2), tissue inhibitor of metalloproteinase (TIMP), neutrophil elastase (NE) and albumin, in descending order, were the most frequently measured analytes in wounds. MMP-9 emerged as the analyte which offers the most potential as a biomarker of wound healing, with elevated levels observed in acute or non-healing wounds and decreasing levels in wounds progressing in healing. Combined measures of different exudate components, such as MMP/TIMP ratios, also appeared to offer substantial potential to indicate wound healing. Finally, temperature measurements are highest in non-healing, worsening or acute wounds and decrease as wounds progress towards healing. Methods used to measure pH, exudate composition and temperature varied greatly and, despite noting some similarities, the studies often yielded significantly contrasting results. Furthermore, a limitation to the generalisability of the findings was the overall quality scores of the research studies, which appeared suboptimal. CONCLUSION: Despite some promising findings, there was insufficient evidence to confidently recommend the use of any of these measures as predictors of wound healing. pH measurement appeared as the most practical method for use in clinical practice to indicate wound healing outcomes. Further research is required to increase the strength of evidence and develop a greater understanding of wound healing dynamics.

Combined use of modulated ultrasound and electric current stimulation for diabetic foot ulcers: a case series.

OBJECTIVE: Diabetic foot ulcers (DFUs) are a significant challenge in wound care practice. Our aim was to evaluate the combined use of of two therapies, ultrasound and electrostimulation, in the treatment of DFUs. METHOD: This study employed a prospective, non-comparative, case series design, undertaken in a podiatry-led diabetic foot clinic, in an acute hospital setting, in an urban location in Ireland. We recruited patinets with hard-to-heal DFUs who were treated twice a week with combined modulated ultrasound and electric current stimulation. RESULTS: We recruited seven patients with eight chronic DFUs. A mean wound size reduction of 71% was achieved and there were no adverse reactions to the therapy. CONCLUSION: The results of this small case series indicate that combined modulated ultrasound and electric current stimulation offers promise as an adjunct therapy for DFUs. Further large scale trials are now warranted.

Accuracy of ultrasound, thermography and subepidermal moisture in predicting pressure ulcers: a systematic review.

OBJECTIVE: Our aims were to: establish the clinical significance of ultrasound, thermography, photography and subepidermal moisture (SEM) measurement; determine the accuracy of ultrasound, thermography, photography and SEM measurement in detecting skin/tissue damage; determine the relative accuracy of one of these assessment methods over another; make recommendations for practice pertaining to assessment of early skin/tissue damage. METHOD: The following databases, Cochrane Wounds Group Specialised Register, The Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid EMBASE, Elsevier version, EBSCO CINAHL, ClinicalTrials.gov , WHO International Clinical Trials Registry (ICTR) and The EU Clinical Trials Register were searched for terms including; thermography, ultrasound, subepidermal moisture, photograph and pressure ulcer. RESULTS: We identified four SEM, one thermography and five ultrasound studies for inclusion in this review. Data analysis indicated that photography was not a method which allowed for the early prediction of PU presence. SEM values increased with increasing tissue damage, with the sacrum and the heels being the most common anatomical locations for the development of erythema and stage I PUs. Thermography identified temperature changes in tissues and skin that may give an indication of early PU development; however the data were not sufficiently robust. Ultrasound detected pockets of fluid/oedema at different levels of the skin that were comparable with tissue damage. Thus, SEM and ultrasound were the best methods for allowing a more accurate assessment of early skin/tissue damage. Using the EBL Critical Appraisal Tool the overall validities of the studies varied between 33.3-55.6%, meaning that there is potential for bias within all the included studies. All of the studies were situated at level IV, V and VII of the evidence pyramid. Although the methodological quality of the studies warrants consideration, these studies showed the potential that SEM and ultrasound have in early PU detection. CONCLUSION: SEM and ultrasound are promising in the detection and prediction of early tissue damage and PU presence. However, these methods should be further studied to clarify their potential for use more widely in PU prevention strategies.

First Measurement of the Atomic Electric Dipole Moment of (225)Ra.

The radioactive radium-225 ((225)Ra) atom is a favorable case to search for a permanent electric dipole moment. Because of its strong nuclear octupole deformation and large atomic mass, (225)Ra is particularly sensitive to interactions in the nuclear medium that violate both time-reversal symmetry and parity. We have developed a cold-atom technique to study the spin precession of (225)Ra atoms held in an optical dipole trap, and demonstrated the principle of this method by completing the first measurement of its atomic electric dipole moment, reaching an upper limit of |d((225)Ra)|<5.0×10(-22) e cm (95% confidence).

A Series of Oral Lesions Presenting to an Otolaryngology Department.

This study was performed to assess the incidence and intraoral distribution of different mucosal lesions in a representative population. Retrospective review of clinical notes and assessment of histology reports of patients were performed, who presented with different oral lesions to University Hospital Galway, between January 2007 and December 2008.Of the 106 histology reports evaluated, 94 were identified as benign lesions while 12 were malignant lesions. 96 of these patients were referred from G.P services, 6 patients were referred from other departments while 4 patients came through emergency department by self referral. The numbers and incidence of the commonest lesions in order of frequency were chronic inflammation 20 (18.8%), papilloma 19 (17.1%), fibroma 09 (8.4%), mucocele 09 (8.4%) and leukoplakia 08 (7.5%).We concluded that majority of the presented oral lesions are benign (88.%). Chronic inflammation (18.8%) is the commonest benign oral lesion and all white lesions which represents 34% of oral lesions are not true leukoplakia.

Ion current as a precise measure of the loading rate of a magneto-optical trap.

We have demonstrated that the ion current resulting from collisions between metastable krypton atoms in a magneto-optical trap can be used to precisely measure the trap loading rate. We measured both the ion current of the abundant isotope 83Kr (isotopic abundance=11%) and the single-atom counting rate of the rare isotope 85Kr (isotopic abundance∼1×10(-11)), and found the two quantities to be proportional at a precision level of 0.9%. This work results in a significant improvement in using the magneto-optical trap as an analytical tool for noble-gas isotope ratio measurements, and will benefit both atomic physics studies and applications in the earth sciences.

Measurement of the hyperfine quenching rate of the clock transition in 171YB.

We report the first experimental determination of the hyperfine quenching rate of the 6s(2) (1)S(0)(F = 1/2) - 6s6p (3)P(0)(F = 1/2) transition in (171)Yb with nuclear spin I = 1/2. This rate determines the natural linewidth and the Rabi frequency of the clock transition of a Yb optical frequency standard. Our technique involves spectrally resolved fluorescence decay measurements of the lowest lying (3)P(0,1) levels of neutral Yb atoms embedded in a solid Ne matrix. The solid Ne provides a simple way to trap a large number of atoms as well as an efficient mechanism for populating (3)P(0). The decay rates in solid Ne are modified by medium effects including the index-of-refraction dependence. We find the (3)P(0) hyperfine quenching rate to be (4.42 ± 0.35) × 10(-2) s(-1) for free (171)Yb, which agrees with recent ab initio calculations.

Indoor airborne bacterial communities are influenced by ventilation, occupancy, and outdoor air source.

Architects and engineers are beginning to consider a new dimension of indoor air: the structure and composition of airborne microbial communities. A first step in this emerging field is to understand the forces that shape the diversity of bioaerosols across space and time within the built environment. In an effort to elucidate the relative influences of three likely drivers of indoor bioaerosol diversity - variation in outdoor bioaerosols, ventilation strategy, and occupancy load - we conducted an intensive temporal study of indoor airborne bacterial communities in a high-traffic university building with a hybrid HVAC (mechanically and naturally ventilated) system. Indoor air communities closely tracked outdoor air communities, but human-associated bacterial genera were more than twice as abundant in indoor air compared with outdoor air. Ventilation had a demonstrated effect on indoor airborne bacterial community composition; changes in outdoor air communities were detected inside following a time lag associated with differing ventilation strategies relevant to modern building design. Our results indicate that both occupancy patterns and ventilation strategies are important for understanding airborne microbial community dynamics in the built environment.

Exercise intervention in breast cancer patients with aromatase inhibitor-associated arthralgia: a pilot study.

Aromatase inhibitors (AIs) block estrogen synthesis and are commonly used as adjuvant treatments for breast cancer patients. A common side effect is joint pain. This was a pilot study to examine implementation of an exercise program in reducing joint pain and improving quality of life (QoL) and functional performance in breast cancer patients treated with AIs. Twenty-six participants completed an 8-week, home-based program that combined upper and lower body resistance exercises with self-selected aerobic exercises. We measured: (1) anthropometry (2) functional performance (grip strength, biceps curl to exhaustion, and sit-to-stand and cardiovascular endurance (3-min step test). Joint pain and QoL were assessed using self-administered surveys. Participants reported a significantly lower number of painful joints, an improvement in QoL and a reduction in depressive symptoms. Significant improvements in grip strength, biceps curl, and sit-to-stand (by 14%, 51% and 15% respectively) were also observed. However, we found no significant changes in cardiovascular endurance or in anthropometric measures. An 8-week, home-based exercise program may provide potential benefit to the breast cancer patients undergoing AI treatment by reducing joint pain, improving functional performance and QoL, and reducing depressive symptoms. Further studies are needed to confirm these results.