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Mohammad Reza Amiri-Nikpour,1 Surena Nazarbaghi,1 Babak Ahmadi-Salmasi,1 Tayebeh Mokari,2 Urya Tahamtan,2 Yousef Rezaei3 1Department of Neurology, Imam Khomeini Hospital, 2School of Medicine, 3Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences, Urmia, Iran Background: Cerebrolysin, a brain-derived neuropeptide, has been shown to improve the neurological outcomes of stroke, but no study has demonstrated its effect on cerebral blood flow. This study aimed to determine the cerebrolysin impact on the neurological outcomes and cerebral blood flow. Methods: In a randomized, double-blinded, placebo-controlled trial, 46 patients who had acute focal ischemic stroke were randomly assigned into two groups to receive intravenously either 30 mL of cerebrolysin diluted in normal saline daily for 10 days (n=23) or normal saline alone (n=23) adjunct to 100 mg of aspirin daily. All patients were examined using the National Institutes of Health Stroke Scale and transcranial Doppler to measure the mean flow velocity and pulsatility index (PI) of their cerebral arteries at baseline as well as on days 30, 60, and 90. Results: The patients’ mean age was 60±9.7 years, and 51.2% of patients were male. The National Institutes of Health Stroke Scale was significantly lower in the cerebrolysin group compared with the placebo group on day 60 (median 10, interquartile range 9–11, P=0.008) and day 90 (median 11, interquartile range 10–13.5, P=0.001). The median of PI in the right middle cerebral artery was significantly lower in the cerebrolysin group compared with the placebo group on days 30, 60, and 90 (P

Kamal Khademvatani,1 Mir Hossein Seyyed-Mohammadzad,1 Mohammad Akbari,1 Yousef Rezaei,2 Ramin Eskandari,3 Alireza Rostamzadeh1 1Department of Cardiology, Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences, Urmia, Iran; 2Seyyed-al-Shohada Heart Center, Urmia University of Medical Sciences, Urmia, Iran; 3Department of Cardiology, Firoozgar Hospital, Iran University of Medial Sciences, Tehran, Iran Background: Vitamin D has been shown to have an anticoagulant effect. A decrease in 25-hydroxyvitamin D [25(OH)D] concentration has also been associated with an increased risk of venous thromboembolism. Hence, we sought to determine the relationship between 25(OH)D levels and idiopathic lower-extremity deep vein thrombosis (DVT). Methods: In a case control study, a total of 82 participants with idiopathic lower-extremity DVT were enrolled along with 85 sex- and age-matched healthy participants as controls. The plasma 25(OH)D levels were measured in all the studied samples. Results: The participants' mean age was 47.1±12.3 years. Baseline characteristics were not significantly different between the groups. The concentration of 25(OH)D was significantly lower in the DVT group compared to that of the control group (17.9±10.3 versus 23.1±12.5 ng/mL, P=0.004). The prevalence of participants with deficient 25(OH)D levels was significantly higher in the both DVT and control groups than those with sufficient 25(OH)D levels (68.3% versus 13.4%, and 49.4% versus 28.2%, respectively, P=0.027). In a multivariate analysis, 25(OH)D levels and sex were found to be the only independent predictors of DVT (odds ratio [OR] 1.05, 95% confidence interval [CI] 1.02–1.08, P=0.001 and OR 0.51, 95% CI 0.26–1.00, P=0.049, respectively). Conclusion: Low levels of 25(OH)D are associated with idiopathic lower-extremity DVT. Further investigation is needed to establish determinants and probable causative role of 25(OH)D. Keywords: vitamin D, venous thromboembolism, idiopathic deep vein thrombosis

Background: The knee is the most commonly injured joint. The internal components of the knee include the meniscuses, the anterior cruciate ligament (ACL) and posterior cruciate ligaments (PCL). Magnetic resonance imaging (MRI) is now used widely because of its high accuracy and noninvasiveness. Our objective was to diagnose internal knee component injuries by MRI and compare its diagnostic value with that of arthroscopic surgery."nMethods: This process research study was carried out between May 2004 and September 2006 on 90 randomly selected patients admitted to the orthopedic ward of Baghiatollah Hospital, Tehran, Iran. Each patient had arthroscopic surgery after undergoing MRI by an expert radiologist."nResults: Out of 90 patients, 81 were male and nine were female. The mean age was 31.6 years (range: 17-71). Among patients with normal ACL as shown by MRI, 42.4% were shown by arthroscopy to have a ruptured ACL. The sensitivity and specificity of MRI in ACL abnormalities were 73% and 77%, respectively. Only 1.3% of the patients with normal PCL by MRI showed PCL rupture upon arthroscopic examination. The evaluation of the lateral meniscus by MRI had a sensitivity and specificity of 40% and 94%, respectively. Likewise, in the medial meniscus, sensitivity and specificity by MRI was 70% and 98%, respectively."nConclusion: According to our study, considerable differences exist between MRI reports and arthroscopic findings in the diagnosis of internal knee injuries. We therefore conclude that sole reliance on MRI reports is not reasonable for making treatment decisions and MRI should be used as just one of the diagnostic tools, in conjunction with other methods, such as physical examination and arthroscopy.

Background: Admission hyperglycemia has been associated with major adverse cardiovascular and cerebrovascular events (MACCEs) in patients with acute coronary syndrome.

Background: The date palm cultivation has a long history in Bushehr province. Throughout the recent decade; the dusts, in addition to direct harmful effects on humans, have adverse effects on health of the population living in this area. The infestation of pests in the southern province of Bushehr has groves. Due to the importance of dates in this area, the total ash and acid insoluble ash as indexes for assessing of chemical pollution and also, mold and yeast as indicators for microbial contamination were evaluated. Recently in a number of dates packaging industries, washing the products after the harvest is done. In current study, the effects of rinsing to decrease the dust pollution on date palm along with, the time effect on the quality and durability of washed and un-washed dates were investigated. Materials and Methods: Overall, 48 washed and un-washed dates were sampled from traditional and technologically advanced packaging industries, equally, and were confirmed according to ISIRI methods. Results: The Averages of total and acid insoluble ashes in washed date samples were:1.05±0.14 and 3.32±0.32%, and for un-washed samples were 1.36±0.27 and 4.59±1.64 percent, respectively. In all date samples were presented the yeast, however, their means were lower than the maximum limit (1 x 104 CFU). Also, all date samples were moldy. The Mean percentage of total ash samples in un-rinsed and rinsed dates were approximately, 1.84 and 1.33 times more than the maximum permissible limit, respectively. The mean of acid insoluble ash in all samples (100%), and 98% of total ash were higher than acceptable levels (p<0.05). The results revealed that the average percentage difference between the two groups were transpicuous, while this difference was not significant (p=0.13). Under the similar conditions, the average amount of yeast in washed date samples, were significantly different (p<0.05) and more than un-wash samples. The Mold levels in un-rinsed and rinsed samples; were 83.3 and 75% higher than the maximum permissible limit. According to the results, regardless of a decrease in amount of molds in washed samples than un-wash samples, the rinsing, was unable to eliminate the pollution, or even decreased it to acceptable levels. Conclusion: According to the findings, present rinsing is not an appropriate method for long storage. Observations, after one year upkeep in the same conditions, expressed that all un-washed date samples were apparently healthy, without any pests and insects. While 91.6% of the washed samples were insectivores, also their textured appearances were very unpleasant. [ABSTRACT FROM AUTHOR]

Classification of vegetation according to their species composition is one of the most important tasks in the application of remote sensing in precision agriculture. To prepare an algorithm for such a mandate, there is a need for ground truth. Field operation is very costly and time consuming. Therefore, some other method must be developed, such as extracting information from the satellite images, which is comparatively cheaper and faster. In this study, we first introduced a simple method for Determination of the Vegetation Specie in full cover pixels (DVS) using their laboratory measured spectral reflectance curves. Then, based on these pixels, a hybrid method for vegetation field classification, which we call SCANN (Spectral Characteristics and Artificial Neural Network), is introduced. In this method, different vegetation spectral reflectance characteristics at the three extremes of green, red, and near-infrared along with an artificial neural network method were used. Comparing the results of DVS with those of field collected data showed near 100% accuracy. Based on the results of DVS, the results of SCANN showed an overall accuracy of more than 94%. This method is suggested for unsupervised classification using Hyperspectral images. [ABSTRACT FROM AUTHOR]

We developed degradable poly(propylene fumarate)/bioactive glass (PPF/BG) composite scaffolds based on a sintered microsphere technique and investigated the effects of BG content on the characteristics of these composite scaffolds. Immersion in a simulated body fluid (SBF) was used to evaluate the surface reactivity of composite scaffolds. The surface of composite scaffolds was covered with hydroxycarbonate apatite layer after 7 days of immersion. Ion concentration analyses revealed a decrease in P concentration and an increase in Si, Ca, and Sr concentrations in SBF immersed with composite scaffolds during the 3-week period. The Ca and P uptake rates decreased after 4 days of incubation. This coincided with the decrease of the Si release rate. These data lend support to the suggestion that the Si released from the BG content of scaffolds present in the polymer matrix was involved in the formation of the Ca-P layer. The evaluation of the in vitro degradation of composite microspheres revealed that the weight of scaffolds remained relatively constant during the first 3 weeks and then started to decrease slowly, losing 10.5% of their initial mass by week 12. Our results support the concept that these new bioactive, degradable composite scaffolds may be used for bone tissue engineering applications.

Objectives: Colloids are added to the priming solution of the cardiopulmonary bypass (CPB) pump to maintain colloid osmotic pressure and prevent fluid overload. This study aimed to compare the effects of 6% hydroxyethyl starch (HES) 130/0.4 and ringer's lactate (RL) priming solution on patients' outcomes undergoing isolated heart valve surgery with CPB., Methods: This randomized clinical trial included one hundred and 20 patients undergoing heart valve surgery, and those were allocated into two groups. Patients in the RL group received 1500 mL of RL, and those in the RL + HES group were given 500 mL of HES and 1000 mL of RL., Results: The patients' median age was 52 (IQR 42-60) and 50 (IQR 40-61) years in the RL + HES and the RL group, respectively ( p = .71). The number of cases that required blood product transfusion in both the operating room and intensive care unit was also significantly higher in the RL + HES group compared to the RL group (RR 2.04, 95% CI 1.50-2.76; p < .01 and RR 1.42, 95% CI 1.01-2.01; p = .05, respectively). Declines in postoperative creatinine levels and platelet counts were higher in the RL + HES compared to the RL group (between-subjects effect p = .007 and p = .038, respectively), while the incidence of acute kidney injury was comparable between groups (RR 0.66, 95% CI 0.13-3.30; p = .55)., Conclusions: Among patients undergoing heart valve surgery with CPB, 6% HES added to RL for priming compared with only RL increased the risk of the need for blood product transfusion over the hospitalization period., 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.

Childhood obesity has become a major non-communicable disease worldwide. It is associated with an increased risk of cardiometabolic factors, including diabetes and hypertension (HTN). The purpose of this study was to evaluate the association between obesity and HTN among Iranian children and adolescents. Cross-sectional data from the SHED LIGHT study performed in Tehran urban area were used in this report. The anthropometric values and blood pressure were analyzed. The obesity status was identified based on body mass index (BMI), waist circumference (WC), and waist-to-height ratio (WHtR). The blood pressure status was defined using percentiles for height, age, and sex. A total of 14,641 children with a mean age of 12.28 ± 3.1 years (6-18) were assessed, and 52.8% of them were boys. The prevalence of HTN was higher among obese compared to healthy weight subjects (p < 0.001). HTN had the strongest association with the central obesity by WC (odds ratio [OR] 4.098, 95% confidence interval [CI] 3.549-4.732), generalized obesity by BMI (OR 3.000, 95% CI 2.749-3.274), and central obesity by WHtR (OR 2.683, 95% CI 2.451-2.936). Moreover, parental university education, having studied in private schools, and the smaller number of household children increased the risk of obesity. The rate of HTN was high among children and adolescents with generalized and central obesities. HTN, elevated blood pressure, boy gender, and socioeconomic status were associated with obesity, emphasizing on the importance of screening and implementing lifestyle changes to decrease future risk of cardiovascular diseases., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: This study aimed to assess the effect of addition of bioactive glass (BG) on the setting time and antibacterial activity of mineral trioxide aggregate (MTA) against Enterococcus faecalis (E. faecalis)., Materials and Methods: In this in vitro study, BG was synthesized by the sol-gel technique and added to MTA powder in certain ratios. Three groups of specimens were fabricated from pure MTA, MTA mixed with 10wt% BG, and MTA mixed with 20wt% BG. The setting time of specimens was measured according to ISO9917-2007. Direct contact test was used to assess the antimicrobial activity of the three groups against E. faecalis. Data were analyzed by repeated measures ANOVA (alpha = 0.05)., Results: Addition of BG (in both concentrations) to MTA decreased its setting time and improved its antibacterial activity against E. faecalis ( p < 0.05). By an increase in concentration of BG (20%), the antimicrobial activity further improved ( p < 0.05)., Conclusion: Addition of BG to MTA in 10wt% and 20wt% concentrations decreased its setting time and improved its antibacterial activity against E. faecalis., Competing Interests: The authors declare that they have no conflicts of interest with any product or method., (Copyright © 2024 Amin Salem Milani et al.)

Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the UK Medical Research Council for the submitted work. SB is a member of the NICE Decision Support Unit and NICE Guidelines Technical Support Unit; has served as a paid consultant, providing methodological advice, to NICE, Roche, IQVIA, and RTI Health Solutions; received payments for educational events from Roche; and has received research funding from European Federation of Pharmaceutical Industries and Associations and Johnson & Johnson. MOu works for and has shares in AstraZeneca. JSR is a deputy editor at JAMA, was formerly an associate editor at The BMJ, and is co-founder (unpaid) of medRxiv; has received research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation programme (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (R01HS025164, R01HL144644), and from Arnold Ventures; was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in September 2022. NJB has received consulting fees from Nobias Therapeutics. AA and YR are associate editors at BMC Trials. OC is an associate editor for Value in Health and has received consulting fees from MSD and Janssen. RC is a founding member of the OMERACT Technical Advisory Group, which might be perceived as a possible conflict of interest. RH has shares in Johnson & Johnson. JHP has been a consultant for AdaptivePhage, Arrevus, Atheln, BavariaNordic, Cellularity, Eicos, Evofem, Eyecheck, Gilead, GSK, Mustang, OPKO, Otsuka, Resolve, Romark, SpineBioPPharma, and UTIlity,Vir. GSC is a statistics editor for The BMJ, and director of the UK EQUATOR Centre. CJW has undertaken consultancy for AB Science, for which his institution has received a fee. DD is an associate editor of Value in Health.

Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the UK Medical Research Council for the submitted work. SB is a member of the NICE Decision Support Unit and NICE Guidelines Technical Support Unit; has served as a paid consultant, providing methodological advice, to NICE, Roche, IQVIA, and RTI Health Solutions; received payments for educational events from Roche; and has received research funding from European Federation of Pharmaceutical Industries and Associations and Johnson & Johnson. MOu works for and has shares in AstraZeneca. JSR is a deputy editor at JAMA, was formerly an associate editor at The BMJ, and is co-founder (unpaid) of medRxiv; has received research support through Yale University from Johnson & Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology, from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation programme (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (R01HS025164, R01HL144644), and from Arnold Ventures; was an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in September 2022. NJB has received consulting fees from Nobias Therapeutics. AA and YR are associate editors at BMC Trials. OC is an associate editor for Value in Health and has received consulting fees from MSD and Janssen. RC is a founding member of the OMERACT Technical Advisory Group, which might be perceived as a possible conflict of interest. RH has shares in Johnson & Johnson. JHP has been a consultant for AdaptivePhage, Arrevus, Atheln, BavariaNordic, Cellularity, Eicos, Evofem, Eyecheck, Gilead, GSK, Mustang, OPKO, Otsuka, Resolve, Romark, SpineBioPPharma, and UTIlity,Vir. GSC is a statistics editor for The BMJ, and director of the UK EQUATOR Centre. CJW has undertaken consultancy for AB Science, for which his institution has received a fee. DD is an associate editor of Value in Health.

Background: There are few studies for detecting rhythm abnormalities among healthy children and adolescents. The aim of the study was to investigate the prevalence of abnormal electrocardiographic findings in the young Iranian population and its association with blood pressure and obesity., Methods: A total of 15084 children and adolescents were examined in a randomly selected population of Tehran city, Iran, between October 2017 and December 2018. Anthropometric values and blood pressure measurements were also assessed. A standard 12-lead electrocardiogram was recorded by a unique recorder, and those were examined by electrophysiologists., Results: All students mean age was 12.3 ± 3.1 years (6-18 years), and 52% were boys. A total of 2900 students (192.2/1000 persons; 95% confidence interval 186-198.6) had electrocardiographic abnormalities. The rate of electrocardiographic abnormalities was higher in boys than girls (p < 0.001). Electrocardiographic abnormalities were significantly higher in thin than obese students (p < 0.001), and there was a trend towards hypertensive individuals to have more electrocardiographic abnormalities compared to normotensive individuals (p = 0.063). Based on the multivariable analysis, individuals with electrocardiographic abnormalities were less likely to be girls (odds ratio 0.745, 95% confidence interval 0.682-0.814) and had a lower body mass index (odds ratio 0.961, 95% confidence interval 0.944-0.979)., Conclusions: In this large-scale study, there was a high prevalence of electrocardiographic abnormalities among young population. In addition, electrocardiographic findings were significantly influenced by increasing age, sex, obesity, and blood pressure levels. This community-based study revealed the implications of electrocardiographic screening to improve the care delivery by early detection.

Introduction: Cardioversion for atrial fibrillation (AF) is routinely implemented in daily practice; however, it can be associated with the development of recurrent AF. In this study we aimed to evaluate the predictors of AF recurrence after electrical cardioversion, and to compare the outcomes of patients with or without AF recurrence during follow-up., Methods: Patients with persistent AF were enrolled from March 2015 to September 2018. Patients with recurrent AF within 6 months after the index cardioversion were considered as AF recurrence (AFR) group, and those with normal sinus rhythm were defined as normal sinus rhythm (NSR) group. Thereafter, all patients were followed up for the incidence of adverse events, including death, requiring dialysis, coronary artery intervention/surgeries, cerebrovascular events, heart failure, and recurrent AF beyond 6 months., Results: Of 129 patients, 11 patients had failed cardioversion and 7 patients lost to follow-up. So, 34 and 77 patients were categorized as the NSR and the AFR groups. During a median follow-up time of 54 (46-75) months, there was a trend for a higher incidence of major adverse events in the AFR group compared to the NSR group ( P =0.063). Lower body mass index (odds ratio [OR] 0.885, 95% confidence interval [CI] 0.794-0.986, P =0.027) and coarse AF before the index cardioversion (OR 3.846, 95% CI 1.189-12.443, P =0.025) were the independent predictors of recurrent AF., Conclusion: In patients with persistent AF undergoing cardioversion, the presence of coarse AF and the lower values of body mass index were found to be associated with the AF recurrence., Competing Interests: The authors have no relevant financial or non-financial interests to disclose., (© 2024 The Author(s).)

Background: In recent years, the electrospinning method has received attention because of its usage in producing a mimetic nanocomposite scaffold for tissue regeneration. Hydroxyapatite and gelatin are suitable materials for producing scaffolds, and curcumin has the osteogenesis induction effect., Aims: This study aimed to evaluate the toxicity and early osteogenic differentiation stimulation of nanofibrous gelatin-hydroxyapatite scaffold containing curcumin on dental pulp stem cells (DPSCs)., Objective: The objective of the present investigation was the evaluation of the proliferative effect and primary osteogenic stimulation of DPSCs with a nanofibrous gelatin-hydroxyapatite scaffold containing curcumin. Hydroxyapatite and gelatin were used as suitable and biocompatible materials to make a scaffold suitable for stimulating osteogenesis. Curcumin was added to the scaffold as an osteogenic differentiation- enhancing agent., Methods: The effect of nano-scaffold on the proliferation of DPSCs was evaluated. The activity of alkaline phosphatase (ALP) as the early osteogenic marker was considered to assess primary osteogenesis stimulation in DPSCs., Results: The nanofibrous gelatin-hydroxyapatite scaffold containing curcumin significantly increased the proliferation and the ALP activity of DPSCs (P<0.05). The proliferative effect was insignificant in the first 2 days, but the scaffold increased cell proliferation by more than 40% in the fourth and sixth days. The prepared scaffold increased the activity of the ALP of DPSCs by 60% compared with the control after 14 days (p<0.05)., Conclusion: The produced nanofibrous gelatin-hydroxyapatite scaffold containing curcumin can be utilized as a potential candidate in tissue engineering and regeneration of bone and tooth., Future Prospects: The prepared scaffold in the present study could be a beneficial biomaterial for tissue engineering and the regeneration of bone and tooth soon., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

This study aimed to investigate whether interleukin 1β (IL-1β) and soluble IL-1 receptor 2 (sIL-1R2) are expressed in human granulosa cells (GCs) and relate to ovarian steroidogenesis. Ninety-six women undergoing in vitro fertilization (IVF) were recruited. RT-PCR and immunocytochemistry were used to detect mRNAs and proteins of IL-1β and IL-1R2, respectively. The steroidogenesis of primary cultured GCs was evaluated following treatment with either IL-1β alone or IL-1β and FSH in combination. There were positive correlations between serum IL-1β and serum progesterone (r = 0.220, p = 0.032) and follicular fluid (FF) estradiol (r = 0.242, p = 0.018). Additionally, serum and FF sIL-1R2 were negatively and positively correlated with FF estradiol (r = -0.376, p = 0.005) and FF progesterone (r = 0.434, p = 0.001), respectively. The mRNA and protein expression of IL-1β and IL-1R2 became evident in GCs. IL-1β alone significantly increased estradiol secretion from GCs, but in the presence of FSH, it could notably promote progesterone secretion in addition to estradiol. In conclusion, IL-1β and sIL-1R2 are expressed in human GCs and substantially contribute to ovarian steroidogenesis, suggesting that the IL-1β system may be a potential target for optimizing ovarian hyperstimulation and steroidogenesis in IVF cycles., Competing Interests: Declaration of interest None., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Propose: An electrocardiogram (ECG) has been extensively used to detect rhythm disturbances. We sought to determine the accuracy of different machine learning in distinguishing abnormal ECGs from normal ones in children who were examined using a resting 12-Lead ECG machine, and we also compared the manual and automated measurement using the modular ECG Analysis System (MEANS) algorithm of ECG features., Methods: Altogether, 10745 ECGs were recorded for students aged 6 to 18. Manual and automatic ECG features were extracted for each participant. Features were normalized using Z-score normalization and went through the student's t-test and chi-squared test to measure their relevance. We applied the Boruta algorithm for feature selection and then implemented eight classifier algorithms. The dataset was split into training (80%) and test (20%) partitions. The performance of the classifiers was evaluated on the test data (unseen data) by 1000 bootstrap, and sensitivity (SEN), specificity (SPE), AUC, and accuracy (ACC) were reported., Results: In univariate analysis, the highest performance was heart rate and RR interval in the manual dataset and heart rate in an automated dataset with AUC of 0.72 and 0.71, respectively. The best classifiers in the manual dataset were random forest (RF) and quadratic-discriminant-analysis (QDA) with AUC, ACC, SEN, and SPE equal to 0.93, 0.98, 0.69, 0.99, and 0.90, 0.95, 0.75, 0.96, respectively. In the automated dataset, QDA (AUC: 0.89, ACC:0.92, SEN:0.71, SPE:0.93) and stack learning (SL) (AUC:0.89, ACC:0.96, SEN:0.61, SPE:0.99) reached best performances., Conclusion: This study demonstrated that the manual measurement of 12-Lead ECG features had better performance than the automated measurement (MEANS algorithm), but some classifiers had promising results in discriminating between normal and abnormal cases. Further studies can help us evaluate the applicability and efficacy of machine-learning approaches for distinguishing abnormal ECGs in community-based investigations in both adults and children., (© 2023. The Author(s) under exclusive licence to Biomedical Engineering Society.)

Background: Interventional trials that evaluate treatment effects using surrogate endpoints have become increasingly common. This paper describes four linked empirical studies and the development of a framework for defining, interpreting and reporting surrogate endpoints in trials., Methods: As part of developing the CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) extensions for randomised trials reporting surrogate endpoints, we undertook a scoping review, e-Delphi study, consensus meeting, and a web survey to examine current definitions and stakeholder (including clinicians, trial investigators, patients and public partners, journal editors, and health technology experts) interpretations of surrogate endpoints as primary outcome measures in trials., Findings: Current surrogate endpoint definitional frameworks are inconsistent and unclear. Surrogate endpoints are used in trials as a substitute of the treatment effects of an intervention on the target outcome(s) of ultimate interest, events measuring how patients feel, function, or survive. Traditionally the consideration of surrogate endpoints in trials has focused on biomarkers (e.g., HDL cholesterol, blood pressure, tumour response), especially in the medical product regulatory setting. Nevertheless, the concept of surrogacy in trials is potentially broader. Intermediate outcomes that include a measure of function or symptoms (e.g., angina frequency, exercise tolerance) can also be used as substitute for target outcomes (e.g., all-cause mortality)-thereby acting as surrogate endpoints. However, we found a lack of consensus among stakeholders on accepting and interpreting intermediate outcomes in trials as surrogate endpoints or target outcomes. In our assessment, patients and health technology assessment experts appeared more likely to consider intermediate outcomes to be surrogate endpoints than clinicians and regulators., Interpretation: There is an urgent need for better understanding and reporting on the use of surrogate endpoints, especially in the setting of interventional trials. We provide a framework for the definition of surrogate endpoints (biomarkers and intermediate outcomes) and target outcomes in trials to improve future reporting and aid stakeholders' interpretation and use of trial surrogate endpoint evidence., Funding: SPIRIT-SURROGATE/CONSORT-SURROGATE project is Medical Research Council Better Research Better Health (MR/V038400/1) funded., Competing Interests: Sylwia Bujkiewicz is a member of the NICE Decision Support Unit (DSU) and NICE Guidelines Technical Support Unit (TSU), has served as a paid consultant, providing methodological advice, to NICE, Roche, IQVIA and RTI Health Solutions, received payments for educational events from NICE and Roche and has received research funding from European Federation of Pharmaceutical Industries & Associations (EEPIA) and Johnson & Johnson. Mario Ouwens works for and has shares in AstraZeneca. Joseph Ross is an Associate Editor at BMJ and co-founder (unpaid) of medRxiv; research support through Yale University from Johnson and Johnson to develop methods of clinical trial data sharing, from the Medical Device Innovation Consortium as part of the National Evaluation System for Health Technology (NEST), from the Food and Drug Administration for the Yale-Mayo Clinic Center for Excellence in Regulatory Science and Innovation (CERSI) program (U01FD005938), from the Agency for Healthcare Research and Quality (R01HS022882), from the National Heart, Lung and Blood Institute of the National Institutes of Health (NIH) (R01HS025164, R01HL144644), and from the Laura and John Arnold Foundation to establish the Good Pharma Scorecard at Bioethics International; expert witness at the request of Relator's attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. Nancy Butcher has received consulting fees from Nobias Therapeutics, Inc. Alain Amstutz and Yousef Rezaei are Associate Editors at BMC Trials. Robin Christensen is a founding member of the OMERACT Technical Advisory Group which might be perceived as a possible conflict of interest. Ray Harris has shares in Johnson and Johnson. John Powers has been a consultant for Adaptive Phage, Arrevus, Atheln, Bavaria Nordic, Cellularity, Eicos, Evofem, Eyecheck, Gilead, GSK, Mustang, OPKO, Otsuka, Resolve, Romark, SpineBioPPharma, UTIlity, Vir. Achilles Thoma received royalties from Springer Publishing for his book “Evidence Based Surgery: A Guide to Understanding and Interpreting the Surgical Literature”, 2019., (© 2023 The Author(s).)

Cardiac consequences of Covid-19 infection have been mentioned in various studies as a serious risk factor for in-hospital mortality. However, the existence of residual cardiac dysfunction after the acute phase is seldom investigated especially in people without a history of specific medical disease. One hundred health care workers with positive reverse transcription-polymerase chain reaction test underwent comprehensive 2D and 3D echocardiography six to eight weeks after infection. Patients were classified into Mild, Moderate, and Severe groups based on their clinical characteristics of covid-19 infection, and all echocardiographic parameters were compared between the three groups. Left ventricular (LV) stroke volume index was reduced in all groups compared to normal ranges and was more prominent in the severe group (P-value < 0.05). 3D-derived LV global longitudinal strain (GLS) was significantly lower in the severe group in comparison to the mild group (- 19.3 ± 1 Vs. - 22.2 ± 2, P-value < 0.001) and correlated with highly sensitive CRP level at the acute phase. Left atrial (LA) strains, including LA peak strain, LA contraction strain, and LA reservoir strain, were considerably higher and LA volume index was significantly lower in the clinically severe covid patients. Analysis based on the extent of lung involvement showed significantly increased 3D-derived right ventricular volumes in patients who experienced severe pneumonia despite normalized strains. Conclusion: subclinical LV dysfunction as reduced stroke volume index and GLS exists in the early recovery phase of normal individuals with severe course of covid-19. LA function indicated by LA strains paradoxically increases in severe covid-19 infection in this phase., (© 2023. The Author(s), under exclusive licence to Springer Nature B.V.)

Background: The body mass index (BMI) has some limitations in identifying obesity, particularly among children and adolescents., Objectives: We sought to determine the reference percentiles of tri-ponderal mass index (TMI) for Iranian population, and its relation to BMI, waist circumference (WC), and waist circumference-to-height ratio (WHtR)., Methods: Baseline characteristics for 14 641 children and adolescents were applied. The area under the characteristics (AUC) curve and optimal cut-off points for TMI were used to define the accuracy of TMI for discriminating general and central obesity compared to other anthropometric measurements., Results: TMI levels remained stable from 6 to 18 years with a small range of difference. The highest AUCs for discriminating obesity according to BMI and WHtR ≥0.5 from non-obese subjects were related to TMI (0.980) and TMI (0.912), respectively, and these findings were similar for both sexes. Moreover, the AUC for TMI to discriminate central obesity by WHtR was higher than that for BMI (0.912 vs. 0.833, p < .001), and this difference was similar among sex and age groups. The optimal value of TMI for discriminating general obesity, obesity by WC, and obesity by WHtR were 15.2 (sensitivity 96.2 and specificity 89.8), 15 (sensitivity 86.9 and specificity 79.9), and 13.9 (sensitivity 85.1 and specificity 81.5), respectively., Conclusions: TMI discriminated central obesity by WHtR more accurately than obesity by BMI among Iranian children and adolescents irrespective of sex. Besides it remained relatively constant across age- and sex-specific groups providing a single optimal cut-off point for screening obesity during childhood and adolescence., (© 2023 Wiley Periodicals LLC.)