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Peter J Illingworth,1 Robert Lahoud,1 Frank Quinn,1 Kendal Chidwick,2 Claire Wilkinson,2 Gavin Sacks1 1IVFAustralia, Greenwich, Sydney, NSW, Australia; 2Scientific Affairs, Merck Serono Australia Pty Ltd, Frenchs Forest, Sydney, NSW, Australia Purpose: Evaluation of patients’ ease of use of the redesigned, disposable, ready-to-use ­follitropin alfa pen during controlled ovarian stimulation for assisted reproductive technology. Methods: This single-center, observational, open-label, single-arm study recruited infertile normo-ovulatory women (aged 18–45 years). Nurses trained patients to self-administer recombinant human follicle-stimulating hormone daily using the follitropin alfa pen (300 IU, 450 IU, and 900 IU). Before treatment, patients completed Questionnaire A. Following self-administered treatment, on stimulation days 5–6 and 7–8 (within a day of receiving recombinant human chorionic gonadotropin), patients completed Questionnaire B. Nurses completed an ease-of-learning/teaching questionnaire. The primary endpoint was proportion of patients rating the pen as “easy/very easy” to use (Questionnaire B) on the final visit before recombinant human chorionic gonadotropin. Secondary endpoints included: proportion of patients rating the follitropin alfa pen as easy to learn, use, prepare, deliver, and dispose of (Questionnaires A and B). Proportions (95% confidence intervals [CIs]) were provided for primary and secondary endpoints. Adverse events were reported descriptively. Results: Eighty-six patients received recombinant human follicle-stimulating hormone. Of the 72 patients who had completed the overall assessment questions, 66 (91.7%; 95% CI =82.7%–96.9%) found the pen “easy” to use. Also, 70/86 (81.4%) patients “strongly agreed/agreed” that, overall, it was easy to learn how to use the pen; 72/86 (83.7%) “strongly agreed/agreed” that easily understandable, verbal information was provided; and 70/86 (81.4%) were confident about using the pen correctly. In total, 24/26 nurses (92.3%; 95% CI =74.9%–99.1%) rated the pen as easy to use. Clinical pregnancy rate/patient/cycle/embryo transfer was 37%. Twenty-six ovarian hyperstimulation syndrome events were reported (none severe; 16 patients [19%]); of these, 13 occurred at embryo transfer. Conclusion: In this observational study, patients had a high acceptance of the redesigned follitropin alfa pen, with most finding it very easy/easy to use. Assisted reproductive technology nurses found the pen very easy/easy to teach. Keywords: controlled ovarian stimulation, ease of learning, ease of teaching, prefilled pen, questionnaire, self-injection

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Objective: We examined the hypothesis that lipoprotein(a) levels are elevated in preeclampsia and associated with severity of the disease.Study Design: Plasma lipoprotein(a) levels were measured in 24 normal pregnant women, 18 mild, and 8 severe preeclamptic women using an enzyme-linked immunosorbent assay method. Kruskall-Wallis one-way analysis of variance was used to evaluate the difference in plasma lipoprotein(a) among different groups. The Mann-Whitney U test was used to compare the differences between two groups.Results: The plasma lipoprotein(a) levels were increased in pregnant women with both severe preeclampsia (median 826.9 mg/L [interquartile range 590.7, 986.9 mg/L], n = 8, p < 0.0001) and mild preeclampsia (median 357.7 mg/L [interquartile range 208.0, 477.1 mg/L], n = 18, p < 0.0001) compared with normal pregnancy (median 78.5 mg/L [interquartile range 45.2, 127.9 mg/L], n = 24). The lipoprotein(a) level was significantly higher in severe than in mild preeclampsia (p < 0.001).Conclusion: This study has demonstrated that lipoprotein(a) levels are elevated in preeclampsia and associated with severity of the disease. It may serve as a marker of the pathogenic process. [ABSTRACT FROM AUTHOR]

Intussusception in adults is a rare condition often associated with a pathological lead point, which is frequently malignant but can occasionally be benign, such as colonic lipomas. We report the case of a 60-year-old male who presented with colicky abdominal pain, and a computed tomography (CT) revealed a colo-colic intussusception caused by a 6 cm lipoma in the transverse colon, accompanied by ischemic changes in the colonic mucosa. The patient underwent a right hemicolectomy, and histopathology confirmed the benign nature of the lesion. This case highlights the importance of early recognition and surgical intervention to prevent complications and rule out malignancy, especially in rare presentations like intussusception caused by lipomas., (© 2024 The Authors. Published by Elsevier Inc. on behalf of University of Washington.)

To assess the value of deep learning in selecting the optimal embryo for in vitro fertilization, a multicenter, randomized, double-blind, noninferiority parallel-group trial was conducted across 14 in vitro fertilization clinics in Australia and Europe. Women under 42 years of age with at least two early-stage blastocysts on day 5 were randomized to either the control arm, using standard morphological assessment, or the study arm, employing a deep learning algorithm, intelligent Data Analysis Score (iDAScore), for embryo selection. The primary endpoint was a clinical pregnancy rate with a noninferiority margin of 5%. The trial included 1,066 patients (533 in the iDAScore group and 533 in the morphology group). The iDAScore group exhibited a clinical pregnancy rate of 46.5% (248 of 533 patients), compared to 48.2% (257 of 533 patients) in the morphology arm (risk difference -1.7%; 95% confidence interval -7.7, 4.3; P = 0.62). This study was not able to demonstrate noninferiority of deep learning for clinical pregnancy rate when compared to standard morphology and a predefined prioritization scheme. Australian New Zealand Clinical Trials Registry (ANZCTR) registration: 379161 ., Competing Interests: Competing interests P.J.I. has provided paid advice to Western Australia government on medical cases and has previously (until June 2022) held shares in Virtus Health, a commercial IVF company. C.V. has received consulting fees, lecture payments and travel expenses from pharmaceutical firms with a commercial portfolio in IVF, and has previously (until June 2022) held shares in Virtus Health, a commercial IVF company. D.K.G. has received a research grant from Vitrolife to develop culture medium. S.M.N. has received consulting fees, lecture payments and travel expenses from pharmaceutical firms with a commercial portfolio in IVF. J.B. and M.G.L. are employees of Vitrolife and own shares in Vitrolife, who have a pending iDAScore patent. R.L.K. has received a grant from a pharmaceutical firm with a commercial portfolio in IVF, has received speaking fees and travel expenses from Vitrolife, who have a pending iDAScore patent. R.L. has received lecture payments and travel expenses from pharmaceutical firms with a commercial portfolio in IVF. M.M. has received lecture payments and travel expenses from pharmaceutical firms with a commercial portfolio in IVF and has previously (until June 2022) held shares in Virtus Health, a commercial IVF company. H.P. and B.T. are employed by a company where Vitrolife funded research. T.H. was previously employed by Vitrolife, who have a pending iDAScore patent. The other authors declare no competing interests., (© 2024. The Author(s).)

Background: Evidence suggests the importance of a person's chronotype in predicting various aspects of an individual's physical and mental health. While the effect of depression on sleep is well established, the impact of a person's specific sleep timing and chronotype on the prevalence of both depression and anxiety has yet to be fully understood, especially among university students, vulnerable to mental health problems. In addition, other factors also seem to influence the occurrence of depression and anxiety among students as well as their quality of sleep, one of which being the students' financial wellness. The objective was to evaluate the association between chronotype and the severity and prevalence of depression among Lebanese university students, while also taking into account the possible connection between chronotype and financial wellness and both anxiety and sleep quality. Methods: This cross-sectional study was conducted between December 2021 and February 2022; 330 Lebanese university students was included (mean age 21.75 ± 2.43; 67.3% females). Results: The majority of the Lebanese university students in our sample were found to have an intermediate typology (63.0%), followed by the evening typology, which appeared to constitute 28.2% of the sample, while only 8.8% possessed a morning typology. In this study, having an intermediate or evening typology compared to a morning one was significantly associated with higher depression and worse sleep quality. In addition, having an evening chronotype compared to a morningness propensity was significantly associated with more anxiety. Conclusion: This study found a positive association between an evening typology (chronotype) and higher depression and anxiety and poorer quality of sleep. Although preliminary and based on cross-sectional data, this research could help provide a better understanding of the different chronotypes among university students, and of the possible increased susceptibility of some of these typologies (i.e., evening-type) to mental health problems., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Nano-roughness has shown great potential in enhancing high-fidelity electrogenic cell interfaces, owing to its characteristic topography comparable to proteins and lipids, which influences a wide range of cellular mechanical responses. Gaining a comprehensive understanding of how cells respond to nano-roughness at the single-cell level is not only imperative for implanted devices but also essential for tissue regeneration and interaction with complex biomaterial surfaces. In this study, we quantify cell adhesion and biomechanics of single cells to nano-roughened surfaces by measuring neural cell adhesion and biomechanics via fluidic-based single-cell force spectroscopy (SCFS). For this, we introduce nanoscale topographical features on polyimide (PI) surfaces achieving roughness up to 25 nm without chemical modifications. Initial adhesion experiments show cell-specific response to nano-roughness for neuroblastoma cells (SH-SY5Y) compared to human astrocytes (NHA) around 15 and 20 nm surface roughness. In addition, our SCFS measurements revealed a remarkable 2.5-fold increase in adhesion forces (150-164 nN) for SH-SY5Y cells cultured on roughened PI (rPI) surfaces compared to smooth surfaces (60-107 nN). Our data also shows that cells can distinguish changes in nano-roughness as small 2 nm (close to the diameter of a single lipid) and show roughness dependence adhesion while favoring 15 nm. Notably, this enhanced adhesion is accompanied by increased cell elongation upon cell detachment without any significant differences in cell area spreading. The study provides valuable insights into the interplay between nano-topography and cellular responses and offers practical implications for designing biomaterial surfaces with enhanced cellular interactions.

Competing Interests: Funding Support and Author Disclosures Dr. Terrien has served as a consultant for Medtronic. Dr. Dauerman has received research grants and served as a consultant regarding TAVR for Medtronic and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The utility of tumour biomarkers has increased considerably in the era of personalised medicine and individualised therapy in oncology. Biomarkers may be prognostic or predictive, and only a handful of markers are currently US Food and Drug Administration (FDA)-approved for clinical use. Tumour markers have a wide array of uses such as screening, establishing a differential diagnosis, assessing risk, prognosis, and treatment response, as well as monitoring disease status. Major overlap exists between biomarkers and their associated pathologies; therefore, despite suggestive imaging features, establishing a differential diagnosis may be challenging for the radiologist. We review common biomarkers that are of interest to radiologists such as carcinoembryonic antigen (CEA), lactate dehydrogenase (LDH), prostate-specific antigen (PSA), beta human chorionic gonadotropin (β-hCG), carbohydrate antigen 19-9 (CA 19-9), alpha fetoprotein (AFP), and carbohydrate or cancer antigen 125 (CA 125), as well as their associated malignant and non-malignant pathologies. We also present relevant case examples from our practice., (Copyright © 2020 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.)

Acute kidney recovery (AKR) is a recently described phenomenon observed after transcatheter aortic valve replacement (TAVR) and is more frequent than acute kidney injury (AKI). To determine the incidence and predictors of AKR between surgical aortic valve replacement (SAVR) and TAVR, we examined patients with chronic kidney disease and severe aortic stenosis who underwent SAVR or TAVR procedure between 2007 and 2017; excluding age <65 or >90, dialysis, endocarditis, non-aortic valve stenosis, or patients died within 48-hours postprocedure. AKR was defined as an increase of estimated glomerular filtration rate (eGFR) >25% and AKI as decrease in eGFR >25% at discharge. Stroke, mortality, major bleeding, transfusion, and length of stay were examined. Multivariate logistic regression analysis was used to examine predictors of AKR. There were 750 transcatheter and 1,062 surgical patients and 319 pairs after propensity matching. AKR was observed in 26% TAVR versus 23.2% SAVR, p = 0.062. Highest recovery was in patients with eGFR <30 for both TAVR (33.7%) and SAVR (34.5%) patients. Independent predictors of AKR were ejection fraction <50% (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.02 to 2.71, p = 0.042), female gender (OR 1.66, 95% CI 1.1 to 2.5, p = 0.015), and obesity (OR 1.5, 95% CI 1.04-2.3, p = 0.032). Diabetes was a negative predictor of AKR (OR 0.55, 95% CI 0.36 to 0.84, p = 0.005). AKR was associated with improved secondary clinical outcomes compared with AKI. In conclusion, AKR is a generalizable phenomenon occurring frequently and similarly among transcatheter or surgical aortic valve patients. Diabetes is a negative predictor of AKR, possibly indicative of less reversible kidney disease., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Risk stratification plays an important role in evaluating patients with no known cardiovascular disease (CVD). Few studies have investigated health-related quality of life questionnaires such as the Medical Outcomes Study Short Form-36 (SF-36®) as predictive tools for mortality, particularly in direct comparison with biomarkers. Our objective is to measure the relative effectiveness of SF-36® scores in predicting mortality when compared to traditional and novel biomarkers in a primary prevention population., Methods: 7056 patients evaluated for primary cardiac prevention between January 1996 and April 2011 were included in this study. Patient characteristics included medical history, SF-36® questionnaire and a laboratory panel (total cholesterol, triglycerides, HDL, LDL, ApoA, ApoB, ApoA1/ApoB ratio, homocysteine, lipoprotein (a), fibrinogen, hsCRP, uric acid and urine ACR). The primary outcome was all-cause mortality., Results: A low SF-36® physical score independently predicted a 6-fold increase in death at 8years (above vs. below median Hazard Ratio [95% confidence interval] 5.99 [3.86-9.35], p<0.001). In a univariate analysis, SF-36® physical score had a c-index of 0.75, which was superior to that of all the biomarkers. It also carried incremental predictive ability when added to non-laboratory risk factors (Net Reclassification Index=59.9%), as well as Framingham risk score components (Net Reclassification Index=61.1%). Biomarkers added no incremental predictive value to a non-laboratory risk factor model when combined to SF-36 physical score., Conclusion: The SF-36® physical score is a reliable predictor of mortality in patients without CVD, and outperformed most studied traditional and novel biomarkers. In an era of rising healthcare costs, the SF-36® questionnaire could be used as an adjunct simple and cost-effective predictor of mortality to current predictors., (Copyright © 2017 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)

Objective: The Kansas City Cardiomyopathy Questionnaire (KCCQ) has emerged as a patient-centered heart failure-specific health status measure. It currently lacks routine and widespread use in clinical practice and trials. The purpose of this study was to examine the correlation between KCCQ and cardiopulmonary exercise testing (CPET) parameters and clinical outcomes, compared with the New York Heart Association functional classification (NYHA)., Methods and Results: We performed a single-centered observational analysis of 432 patients who presented to the Heart Failure Department, completed the KCCQ, and underwent CPET. The 1-year clinical outcome assessed was a composite of mortality, heart failure hospitalization, and need for heart transplantation or left ventricular assist device. In the KCCQ, the physical limitation domain had a correlation with peak VO 2 similar to NYHA (r = 0.48; P < .001; and r = -0.48; P < .001; respectively), and slightly better correlation with ventilatory threshold (r = 0.42; P < .001; and r = -0.40; P < .001; respectively). According to model validation, the KCCQ physical limitation domain and NYHA were similar predictors of peak VO 2 (r 2  = 0.229; and r 2  = 0.227; respectively). KCCQ predicted the specified 1-year clinical outcome (hazard ratio 0.75, 95% confidence interval 0.69-0.82; P < .001) and provided incremental predictive ability when added to a model that included NYHA, with a net reclassification index of 76.1% (P < .001)., Conclusions: KCCQ and NYHA provide similar assessment of functional capacity. KCCQ predicts 1-year clinical outcomes, providing incremental value over NYHA. These findings support its routine use in clinical care, as well as its potential to serve as a measure in clinical trials., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: The aim of this study was to assess the use of recombinant luteinizing hormone (rLH) supplementation in patients who experience a reduction in LH concentration during controlled ovarian hyperstimulation (COH) for IVF/ICSI., Methods: A multi-center prospective randomized controlled trial (RCT) was performed over three years. Two hundred and forty patients aged between 24 and 42 years undergoing IVF/ICSI treatment with a long down regulation (LDR) protocol were recruited. LH was measured on the day FSH was started and again 6days later. 100 patients had a 50% or greater reduction in LH levels and these were randomized to receive either recombinant LH (rLH) supplementation (group 1, n=43) or no additional rLH supplementation (group 2, n=57). Group 1 received rLH 75IU daily from day 7 of FSH stimulation to the day of HCG trigger., Results: There were no differences in either live birth or clinical pregnancy rates per embryo transfer between the two groups (27.8% vs. 37.0%, p=0.39, RR=0.75, 95%CI 0.39-1.44 and 36.1% vs. 43.5% p=0.51, RR=0.84, 95%CI 0.5-1.48, respectively)., Conclusion: In conclusion the addition of rLH in patients with a relative reduction in serum LH concentration during COH for IVF/ICSI did not improve live birth or clinical pregnancy rates. However the results were not conclusive and further large well-designed RCTs are required to confirm these findings., (Copyright © 2017 Elsevier B.V. All rights reserved.)

The purpose of this study was to examine the changes in activated protein C (APC) anticoagulant activity during pregnancy and determine whether changes in APC could contribute to thrombosis in the placental bed in preeclampsia. We measured APC anticoagulant activity in 150 women with a normal pregnancy and 50 women with preeclampsia. There was a significant reduction in the mean APC sensitivity ratio (APC-SR) during pregnancy (p<0.001). APC resistance in preeclampsia was significantly higher than in normal pregnancy (p<0.01). Amongst women with APC resistance the presence of the factor V Leiden mutation was significantly higher in the preeclampsia group than in the normal pregnancy group (p<0.01). It seems that both factor V Leiden mutation and APC resistance may be associated with the development of preeclampsia. These results suggest that APC resistance may be an important mechanism underlying placental bed pathology in pregnancy and may be associated with an increased tendency to develop preeclampsia in some women. Assay of APC resistance and factor V Leiden mutation should be performed in women with preeclampsia.

Normal patency was restored to the right fallopian tube of a 41-year-old sterilised woman by laparoscopic tubotubal reanastomosis. We believe that this is the first report of this procedure in Australia. Laparoscopic tubotubal reanastomosis combines the high success rates of microsurgical tubotubal reanstomosis with the advantages of the laparoscopic approach.

The concurrent problems of bleeding placenta praevia and thromboembolism present a difficult management problem. We present a case of pulmonary embolism successfully treated with low molecular weight heparin in a woman with a major grade placenta praevia, who required emergency operative delivery.