bluuebunny/crossref_metadata_2025_split huggingface dataset:
The need for a system view to regulate artificial intelligence/machine learning-based software as medical device
Authors: Gerke Sara , Babic Boris , Evgeniou Theodoros , Cohen I. Glenn 
Published: April 2020

AbstractArtificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug Administration (FDA), for example, has recently proposed a discussion paper to address some of these issues. But it misses an important point: we argue that regulators like the FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition.
Dead or alive: sediment DNA archives as tools for tracking aquatic evolution and adaptation
Authors: Ellegaard Marianne , Clokie Martha R. J. , Czypionka Till , Frisch Dagmar , Godhe Anna , Kremp Anke , Letarov Andrey , McGenity Terry J. , Ribeiro Sofia , John Anderson N. 
Published: April 2020

AbstractDNA can be preserved in marine and freshwater sediments both in bulk sediment and in intact, viable resting stages. Here, we assess the potential for combined use of ancient, environmental, DNA and timeseries of resurrected long-term dormant organisms, to reconstruct trophic interactions and evolutionary adaptation to changing environments. These new methods, coupled with independent evidence of biotic and abiotic forcing factors, can provide a holistic view of past ecosystems beyond that offered by standard palaeoecology, help us assess implications of ecological and molecular change for contemporary ecosystem functioning and services, and improve our ability to predict adaptation to environmental stress.
Bilateral Subthalamic Nucleus Deep Brain Stimulation in Elderly Patients With Parkinson Disease: A Case-Control Study
Authors: Mitchell Kyle T , Younce John R , Norris Scott A , Tabbal Samer D , Dowling Joshua L , Rich Keith M , Perlmutter Joel S , Ushe Mwiza 
Published: April 2020

Abstract

BACKGROUND
Subthalamic nucleus deep brain stimulation (STN DBS) is an effective adjunctive therapy for Parkinson disease. Studies have shown improvement of motor function but often exclude patients older than 75 yr.

OBJECTIVE
To determine the safety and effectiveness of STN DBS in patients 75 yr and older.

METHODS
A total of 104 patients (52 patients >75 yr old, 52 patients <75 yr old) with STN DBS were paired and retrospectively analyzed. The primary outcome was change in Unified Parkinson Disease Rating Scale (UPDRS) subscale III at 1 yr postoperatively, OFF medication. Secondary outcomes were changes in UPDRS I, II, and IV subscales and levodopa equivalents. Complications and all-cause mortality were assessed at 30 d and 1 yr.

RESULTS
Both cohorts had significant improvements in UPDRS III at 6 mo and 1 yr with no difference between cohorts. Change in UPDRS III was noninferior to the younger cohort. The cohorts had similar worsening in UPDRS I at 1 yr, no change in UPDRS II, similar improvement in UPDRS IV, and similar levodopa equivalent reduction. There were similar numbers of postoperative intracerebral hemorrhages (2/52 in each cohort, more severe in the older cohort) and surgical complications (4/52 in each cohort), and mortality in the older cohort was similar to an additional matched cohort not receiving DBS.

CONCLUSION
STN DBS provides substantial motor benefit and reduction in levodopa equivalents with a low rate of complications in older patients, which is also noninferior to the benefit in younger patients. STN DBS remains an effective therapy for those over 75 yr.
Robot-Assisted Instrumented Fusion of a T8-9 Extension Distraction Fracture and Epidural Hematoma Evacuation: 2-Dimensional Operative Video
Authors: Al Saiegh Fadi , Leibold Adam , Mouchtouris Nikolaos , Sabourin Victor , Stefanelli Anthony , Franco Daniel , Harrop James , Jallo Jack , Prasad Srinivas , Heller Joshua 
Published: April 2020

Abstract
The utilization of robotics has been gaining increased popularity in spine surgery. It can be used to assist in pedicle screw insertion when anatomy is complex in deformity surgery, but is also helpful in degenerative spine as it can minimize tissue dissection and fluoroscopy use.
1-6
We present an operative video that demonstrates the use of a robotic system (Globus Excelsius GPS, Audubon, Pennsylvania) for thoracic instrumentation in an unstable fracture. The patient we present is a 64-yr-old male who sustained a T8-9 distraction extension fracture after falling down a flight of stairs. His computed tomography (CT) scan showed ossification of the anterior longitudinal ligament making ankylosing spondylitis the likely underlying condition.
7,8
His magnetic resonance imaging showed an epidural hematoma extending from T7 to T11. Due to the unstable nature of this fracture and the presence of the hematoma, informed consent was obtained and the patient underwent thoracic pedicle screw fixation from T7 to T11 and laminectomy for hematoma evacuation. A preoperative CT was done for screw trajectory planning. Paraspinal muscle dissection was limited to the hematoma level to allow for laminectomy and evacuation. After registration of the patient to the robotic system using C-arm fluoroscopy, pilot burr holes are drilled using a rigid robotic arm and with optical tracking in real time. This reduces the degrees of freedom and allows for higher precision of screw placement. To the authors’ knowledge, this video is the first one to show the utilization of robotics for thoracic instrumentation in an acute fracture.
Hydrogen Protons Modulate Perivascular Axo–axonal Interactions in the Middle Cerebral Artery of Rats
Authors: Huang Kuo-Feng , Chang Hsi-Hsien , Hsieh Cheng-Hsing , Shei-Dei Yang Stephen , Chang Shang-Jen 
Published: April 2020

Abstract:
Previous studies have demonstrated that nicotine can induce relaxation of the middle cerebral artery (MCA). However, whether this relaxation is associated with the activity of sensory calcitonin gene–related peptide (CGRP) nerves and whether this is modulated by hydrogen protons (H+), facilitating the release of CGRP from sensory CGRPergic nerve terminals in the MCA, remains unclear. In this study, we examined the role of H+ in the modulation of neurogenic vasomotor responses in the rat-isolated endothelium-denuded MCA. Wire myography was used to measure vasoreactivity and indicated that nicotine-induced relaxation was sensitive to tetrodotoxin and lidocaine and drastically reduced levels of guanethidine (an adrenergic neuronal blocker), NG-nitro-L-arginine (L-NNA), CGRP8-37, vasoactive intestinal polypeptide (VIP)6-28, capsaicin, capsazepine (a transient receptor potential vanilloid-1 inhibitor), and tetraethylammonium. However, this nicotine-induced relaxation was not sensitive to propranolol. Lowering the pH of the buffer solution with HCl caused pH-dependent vasorelaxation and deceased intracellular pH in the MCA rings, which was sensitive to L-NNA, CGRP8-37, VIP6-28, capsazepine, 4-aminopyridine (a voltage-gated potassium channel antagonist), and paxilline (a large conductance Ca2+-activated K+ channel antagonist). However, HCl-induced relaxation was not inhibited by glibenclamide (an ATP-sensitive K+ channel blocker). These results suggested that electrical and chemical activation of cerebral perivascular adrenergic nerves led to the release of H+, which then facilitated the release of NO, VIP, and CGRP, resulting in vasorelaxation. Lowering the pH of the buffer solution caused potassium channels of vascular smooth muscle cells and perivascular nerves to open. In conclusion, our results demonstrated that H+ may act as a modulator on MCA perivascular nerves and/or smooth muscles.
High-flow Nasal Oxygen Versus Standard Oxygen During Flexible Bronchoscopy in Lung Transplant Patients
Authors: Ben-Menachem Erez , McKenzie Jane , O’Sullivan Chris , Havryk Adrian P. 
Published: April 2020

Background:
Diagnostic and interventional flexible bronchoscopy (FB) is increasingly utilized in complex and high-risk patients. Patients are often sedated for comfort and procedure facilitation and hypoxia is commonly observed in this setting. We hypothesized that high-flow nasal oxygen (HFNO) would reduce the incidence of patients experiencing oxygen desaturation.

Methods:
In this randomized controlled trial, postlung transplant patients booked for FB with transbronchial lung biopsy were assigned to either HFNO or low-flow nasal oxygen (LFNO). The patient and bronchoscopist were blinded to group allocation. The primary endpoint was the proportion of patients experiencing mild desaturation [peripheral oxygen saturation (SpO2)<94%]. Secondary endpoints included desaturation (SpO2<90%), the number of airway interventions required and procedure interruptions, the duration of oxygen desaturation and patient, bronchoscopist and anesthesiologist satisfaction scores.

Results:
The trial analyzed data from 76 patients (LFNO, n=39; HFNO, n=37). HFNO reduced the proportion of patients experiencing SpO2<94% (43.2% vs. 89.7%, P<0.001) and SpO2<90% (16.2% vs. 69.2%, P<0.001). The FB was interrupted 11 times in 9 patients in the LFNO group, whereas there were no interruptions in the HFNO group. There were no differences in patient and bronchoscopist satisfaction scores between groups, anesthesiologists had higher satisfaction scores when using HFNO (P<0.001).

Conclusion:
Hypoxia occurred less commonly in postlung transplant patients receiving HFNO during FB. Further studies are warranted in other high-risk populations undergoing longer duration FB.
Practice Patterns for Women With Overactive Bladder Syndrome: Time Between Medications and Third-Line Treatments
Authors: Kirby Anna C. , Park Sungchul , Cook Sara B. , Odem-Davis Katherine , Gore John L. , Wolff Erika M. 
Published: April 2020

Objective
The aims of this study are to determine how long it takes female patients with overactive bladder (OAB) to receive third-line treatment after starting OAB medications and identify factors associated with increased time.

Methods
This was a retrospective observational cohort study of adult female patients with OAB who received third-line treatment between 2013 and 2015 using insurance claims databases. Primary outcome was time between first OAB medication and first third-line treatment. Additional variables were patient demographics, diagnostic tests, and medical comorbidities.

Results
Of 3232 patients included in this study, 48.8% underwent sacral neuromodulation, 31.6% percutaneous tibial nerve stimulation, and 23% intradetrusor onabotulinumtoxin A injections. Twenty-one percent of patients filled medication prescriptions for 3 or more antimuscarinic medications, 30.4% took mirabegron, and 32.3% had advanced diagnostic tests suggestive of a specialist evaluation prior to starting medications. Median time to third-line treatment was 37.7 (interquartile range, 14.9, 16.3) months. Adjusted linear regression model revealed 2 predominant predictors of time to third-line treatments: each antimuscarinic medication trial was associated with 5.3 (95% confidence interval, 4.4–6.3) more months before third-line treatment (P < 0.001), and advanced diagnostic evaluations prior to starting medications were associated with 28.2 (95% confidence interval, 21–35) fewer months before third-line treatment (P < 0.001).

Conclusions
Women with OAB who undergo third-line therapy do so on average more than 3 years after starting medications. Time to third-line treatment is largely driven by the number of antimuscarinic medications tried and timing of diagnostic evaluation by a specialist. Based on these results, we suggest providers consider limiting antimuscarinic trials to 2 medications prior to moving on to other treatment options.
The distress of Iranian adults during the Covid-19 pandemic – More distressed than the Chinese and with different predictors
Authors: Jahanshahi Asghar Afshar , Dinani Maryam Mokhtari , Madavani Abbas Nazarian , Li Jizhen , Zhang Stephen X. 
Published: April 2020

SummaryEarly papers on the mental health of the public during the Covid-19 pandemic surveyed participants from China. Outside of China, Iran has emerged as one of the most affected countries with a high death count and rate. The paper presents the first empirical evidence from Iranian adults during the Covid-19 pandemic on their level of distress and its predictors. On March 25–28, 2020, a dire time for Covid-19 in Iran, we surveyed 1058 adults from all 30 provinces in Iran using the Covid-19 Peritraumatic Distress Index (CPDI). The distress level of Iranian adults (mean: 34.54; s.d.: 14.92) was significantly higher (mean difference: 10.9; t=22.7; p<0.0001; 95% CI: 10.0 to 11.8) than that of Chinese adults (mean: 23.65; s.d.: 5.45) as reported in a prior study with the same measure of Covid-19 Peritraumatic Distress Index (CPDI). We also found the predictors of distress in Iran vary from those in China. Our findings that the predictors of distress in Iran vary from those in China suggest the need to study the predictors of mental health in individual countries during the Covid-19 pandemic to effectively identify and screen for those more susceptible to mental health issues.FundingNone
Familial clustering of erosive hand osteoarthritis in a large statewide cohort
Authors: Kazmers Nikolas H. , Meeks Huong D. , Novak Kendra A. , Yu Zhe , Fulde Gail L. , Thomas Joy L. , Barker Tyler , Jurynec Michael J. 
Published: April 2020

AbstractObjectivesErosive hand osteoarthritis (EOA) is a severe and rapidly progressing form of osteoarthritis. Its etiology remains largely unknown, which has hindered development of successful treatments. Our primary goal was to test the hypothesis that EOA would demonstrate familial clustering in a large statewide population linked to genealogical records, which would suggest a genetic contribution to the pathogenesis of this condition. Our secondary purpose was to determine the association of potential risk factors with EOA.MethodsPatients diagnosed with EOA were identified by searching medical records from a comprehensive statewide database, the Utah Population Database (UPDB). Affected individuals were then mapped to pedigrees to identify high-risk families with excess clustering of EOA as defined by a Familial Standardized Incidence Ratio (FSIR) of ≥ 2.0. The magnitude of familial risk of EOA in related individuals was calculated using Cox regression models. Association of potential EOA risk factors was analyzed using conditional logistic regression and logistic regression models.ResultsWe identified 703 affected individuals linked to 240 unrelated high-risk pedigrees with excess clustering of EOA (FSIR ≥ 2.0). The relative risk of developing EOA was significantly elevated in first-degree relatives. There was a significant association with the diagnosis of EOA and age, sex, diabetes, and obesity.ConclusionsFamilial clustering of EOA observed in a statewide database indicates a potential genetic contribution to the etiology of the disease. Identification of causal gene variants in these high-risk families may provide insight into the genes and pathways that contribute to EOA onset and progression.
The effect of event experience quality on the satisfaction and behavioral intentions of motocross World Championship spectators
Authors: Çevik Hüseyin , Şimşek Kerem Yıldırım 
Published: April 2020

PurposeThe purpose of this study is to examine the theoretical relationship between experience quality (EXQ), satisfaction and the behavioral intentions (BI) of Motocross World Championship spectators.Design/methodology/approachThe research data were collected from spectators who participated in the World Motocross Championship race held in Afyon, Turkey in 2018. The structural equation model (SEM) was used to test the relationship among the research variables.FindingsThe results showed EXQ had significant and direct effects on satisfaction and BI. In addition to this, satisfaction had a partial mediating effect between EXQ and BI.Originality/valueTo date there has been no empirical study examining the consumer behaviors of motocross event spectators. Consequently, this research provides important contributions to the literature and informs event organizers about the role of EXQ in terms of understanding the behavior of motocross event spectators.
Preparation, mechanical properties, and toughening mechanisms of SiCw/SiCp‐reinforced zirconia‐toughened alumina ceramics
Authors: Liu Longyang , Chen Xianzhi , Li Qiyu , Chen Shuaifeng , Chen Yongjun , Li Jianbao , Li Changjiu , Luo Lijie 
Published: April 2020

ABSTRACTZirconia‐toughened alumina (ZTA) ceramics with high mechanical properties were sintered by hot‐pressing method using SiC particles (SiCp) and SiC whiskers (SiCw) as the reinforcing agents simultaneously. The influences of sintering temperature, SiCp, and SiCw contents on the microstructure and mechanical properties of ZTA ceramics were investigated. It was found that both SiCp and SiCw could contribute to grain refinement significantly and promote the mechanical properties of the ceramics. However, the excess addition of SiCp or SiCw led to the formation of pores with large sizes and degraded the mechanical properties instead. When 13 wt% SiCp was introduced, the maximum flexural strength of 1180.0 MPa and fracture toughness of 15.9 MPa·m1/2 were obtained, whereas the maximum flexural strength of 1314.0 MPa and fracture toughness of 14.7 MPa·m1/2 were achieved at 20 wt% SiCw. Interestingly, the simultaneous addition of SiCp and SiCw could further improve the mechanical properties, and the highest flexural strength of 1334.0 MPa and fracture toughness of 16.0 MPa·m1/2 were achieved at a SiCw/SiCp ratio of 16/4. The reinforcement mechanisms in the ceramics mainly included the phase transformation toughening of ZrO2, the crack deflection and bridging of SiCp and SiCw, and the pull‐out of SiCw.
Further Details of a Numerical Analysis on the Thermal Hydraulic Effect of Wrapped Wire Spacers in Fuel Bundle
Authors: Kiss Attila , Mervay Bence 
Published: April 2020

Abstract
The application of relatively simple and cheap wrapped wire spacer in the European supercritical water-cooled reactor (SCWR) (high-performance light water reactor (HPLWR)) has been proposed in order to provide enhanced heat transfer in the fuel assembly without unacceptable penalty in pressure loss. The wires cause twisting flow in the fuel assembly, which means the coolant not only flows straight in the axial direction but also has a significant transverse velocity component, and strong mixing between neighboring subchannels occurs. The aim of this ongoing research is to numerically investigate the effect of wrapped wire spacers on thermal hydraulics of the turbulent coolant flow and its heat transfer in a small bundle of four fuel rods. One bare and six-wired geometries with varying wire pitches (1–6 turn(s) of wires) have been studied. It was found that the wires generate significant amount of transverse velocity, decrease the wall temperature, and increase the heat transfer coefficient mostly in corner subchannels which were the hottest in bare geometry. Thus, the presence of wires enhances heat transfer where it is most needed. Temperature hot spots with moderate values have been identified on the cladding wall of fuel rods. Based on the results, a technically optimal choice of number of wire turns from thermal hydraulic sense has been proposed.
Comparing the efficacy and safety of insulin detemir versus neutral protamine hagedorn insulin in treatment of diabetes during pregnancy: a randomized, controlled study
Authors: ji Jing , He Zhangya , Yang Zhao , Mi Yang , Guo Na , Zhao Hong , Gao Jiayi , Ma Zhengfeei , Luo Xiaoqin , Han Zhen 
Published: April 2020

ObjectiveTo compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) insulin used in pregnant women with diabetes.Research design and methodsA randomized study was conducted in diabetic pregnant women (n=240) (including 132 with pregestational diabetes and 108 with gestational diabetes). All patients were randomly divided into two groups: IDet group (n=120) treated with IDet plus short acting insulin Novolin-R before three meals (RRR–IDet plan), and NPH group treated with NPH plus Novolin-R before three meals (RRR–NPH plan). Patients were enrolled during 12–28 gestation weeks and followed up until delivery.ResultsBasal characteristics, such as age, enrollment gestational weeks, average HbA1c, fasting plasma glucose (FPG) and oral glucose tolerance test (OGTT) were similar between two groups. After 1 week of treatment, the FPG of IDet group were significantly lower than NPH group (p<0.05) and the time required to reach the targeted blood glucose level was significantly shorter (p<0.001). After 3 months of treatment, the HbA1c level in the two groups was normalized but there was no significant difference in HbA1c level. Maternal and neonatal outcomes were comparable between the two therapeutic approaches; however, the incidence of hypoglycemia in IDet group was remarkably lower than that of NPH group (p<0.05). The adverse drug reactions were rare and similar between the two groups.ConclusionsFor the treatment of gestational diabetes, both RRR–IDet plan and RRR–NPH plan were reported to control blood glucose effectively. Compared with NPH, IDet could control blood glucose and reached the targets faster and more effectively, thus reducing the number of insulin injections and the incidence of hypoglycemia in pregnant women without increasing adverse birth outcomes. Therefore, for pregnant women with gestational diabetes, who require insulin therapy, IDet would be an ideal basal insulin being worthy of promotion in clinical settings.