bluuebunny/crossref_metadata_2025_split huggingface dataset:
Consistency of efficacy results across various clinical measures and statistical methods in the lecanemab phase 2 trial of early Alzheimer’s disease
Authors: Dhadda Shobha , Kanekiyo Michio , Li David , Swanson Chad J. , Irizarry Michael , Berry Scott , Kramer Lynn D. , Berry Donald A. 
Published: December 2022

AbstractBackgroundLecanemab (BAN2401) is a humanized IgG1 monoclonal antibody that preferentially targets soluble aggregated Aβ species (protofibrils) with activity at insoluble fibrils and slowed clinical decline in an 18-month phase 2 proof-of-concept study (Study 201; ClinicalTrials.gov NCT01767311) in 856 subjects with early Alzheimer’s disease (AD). In this trial, subjects were randomized to five lecanemab dose regimens or placebo. The primary efficacy endpoint was change from baseline in the Alzheimer’s Disease Composite Score (ADCOMS) at 12 months with Bayesian analyses. The key secondary endpoints were ADCOMS at 18 months and Clinical Dementia Rating-Sum-of-Boxes (CDR-SB) and Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) at 18 months. The results have been published previously. Herein, we describe the results of sensitivity analyses evaluating the consistency of the lecanemab efficacy results in Study 201 at the identified dose, the ED90, across multiple statistical methods and multiple endpoints over the duration of the study.MethodsThe protocol-specified analysis model was a mixed model for repeated measures (MMRM). Sensitivity analyses address the consistency of the conclusions using multiple statistical methods. These include a disease progression model (DPM), a natural cubic spline (NCS) model, a quadratic mixed model (QMM), and 2 MMRMs with additional covariates.ResultsThe sensitivity analyses showed positive lecanemab treatment effects for all endpoints and all statistical models considered. The protocol-specified ADCOMS analysis showed a 29.7% slower decline than placebo for ADCOMS at 18 months. The various other analyses of 3 key endpoints showed declines ranging from 26.5 to 55.9%. The results at 12 months are also consistent with those at 18 months.ConclusionsThe conclusion of the primary analysis of the lecanemab Study 201 is strengthened by the consistently positive conclusions across multiple statistical models, across efficacy endpoints, and over time, despite missing data. The 18-month data from this trial was utilized in the design of the confirmatory phase 3 trial (Clarity AD) and allowed for proper powering for multiple, robust outcomes.
Monitoring of an electrically induced signal in melon in relation to different environmental conditions in a smart farm
Authors: Park Jin Hee , Park Gyung Min , Kim Eun Jeong , Jeon Yu Min 
Published: December 2022

AbstractA smart farm that automatically regulates environmental conditions such as temperature, humidity and nutrient supply will maximize crop production per unit area by using ICT-based technology. To control the environment in a smart greenhouse, plant growth should be monitored in real time. The physiological activity of a plant was monitored by receiving an electrical signal from inside the plant stem which changed when the plant absorbed nutrients and water. In this study, the environmental conditions in different areas of a smart farm were not much different, and growth parameters were not much affected by the environmental conditions of the area. However, a plant induced electrical signal (PIES) was associated with the atmospheric and media temperature and relative humidity although there was time lag of 6 ~ 7 h for the peaks of the PIES and other environmental conditions. Therefore, monitoring a PIES will make it possible to improve the growth environments in smart farms.
Anesthetic management of hepatectomy for the patient with Fontan circulation: a case series
Authors: Sumie Makoto , Kameyama Nozomi , Akasaka Taiki , Tanaka Yuto , Ando Taichi , Kandabashi Tadashi , Karashima Yuji , Yamaura Ken 
Published: December 2022

Abstract
Background
Hepatectomy for patients with Fontan circulation consists of high central venous pressure and low pulmonary vascular resistance, and is challenging for physicians.

Case presentation
We performed anesthetic management for hepatectomy in three patients with Fontan circulation. Massive bleeding and transfusion as well as careful management were needed. Open abdominal surgery had to be conducted instead of laparoscopic surgery for controlling bleeding in one case. We successfully performed general anesthesia using nitric oxide and inotropes while monitoring arterial pressure and central venous pressure in all the cases.

Conclusions
To maintain Fontan circulation during hepatectomy, it is important to manage central venous pressure and ensure appropriate circulatory volume.
Drastic improvement of cardiac function after living-donor renal transplantation in a long-term hemodialysis patient with severe mitral regurgitation
Authors: Noguchi Satoko , Saito Junichi , Hashiba Eiji , Hirota Kazuyoshi 
Published: December 2022

Abstract
Background
Although there are reports of recovery of cardiac function after renal transplantation, the feasibility of renal transplantation in patients with low cardiac function remains controversial.

Case presentation
A 59-year-old Japanese male was scheduled to undergo living-donor renal transplantation (LDRT) under general anesthesia. Preoperative transthoracic echocardiography revealed severe mitral regurgitation (MR) and a left ventricular ejection fraction (LVEF) at 30%. LDRT was conducted prior to cardiac surgery with restrictive fluid management and close monitoring of cardiac function. The patient’s renal function improved promptly after the LDRT, and his hemodynamics were stable throughout the perioperative period. Along with improvements in the patient’s renal function and anemia, the patient’s cardiac function improved to LVEF 50% and achieved drastically improved MR as well as cardiac function, without intervention.

Conclusion
This case indicates that LDRT has the potential to improve cardiac function in patients who have been on hemodialysis for more than 20 years.
Thermoregulatory response and oxidative stress indices of rabbit bucks administered ascorbic acid and sodium bicarbonate in a humid tropical environment
Authors: Ewuola Emmanuel Olubisi , Sanni Ridwan Olamide , Aina Taiwo , Oni Oluwatosin , Jimoh Olatunji Abubakar 
Published: December 2022

Abstract
Background
This study aimed to assess the effect of ascorbic acid and sodium bicarbonate on thermoregulatory response and oxidative stress markers of rabbit bucks during highest temperature-humidity index in a humid tropical environment as a mitigation strategy against impact of high ambient temperature on the animals. Twenty-eight exotic rabbit bucks of 9 months old weighing 2.54 ± 0.23 kg were randomly allotted to four treatments consisting of T1 (Control-2 ml of sterile water), T2 (2 ml of 300 ppm ascorbic acid), T3 (2 ml of 0.30% sodium bicarbonate) and T4 (2 ml mixture of 150 ppm ascorbic acid + 0.15% sodium bicarbonate, administered orally at 48 h interval for 12 weeks. After a month of administration, rectal temperature, ear temperature, respiratory rate and pulse rate were monitored twice daily (8:00 am and 4:00 pm). Semen samples were collected from all bucks weekly for seminal lipid peroxidation and total antioxidant activity assay. Blood samples were collected from all bucks and serum obtained using standard procedure to assay for lipid peroxidation and total antioxidant activity.

Results
The result revealed that the rabbits were exposed to very severe heat stress for greater part of the day. At week 5, bucks on T2, T3 and T4 had increased respiratory rate at 8 am than those on T1, similar trend was observed at week 4 and 6. At 4 pm, the pulse rate was significantly (p < 0.05) different among the treatments at weeks 11, bucks on T2, T3 and T4 had significantly lowered (p < 0.05) pulse rate than those on T1. The administration of ascorbic acid, sodium bicarbonate and its combination did not significantly (p > 0.05) influence the ear and rectal temperature of the bucks. At week 11, seminal total antioxidant activity of bucks on T1, T2 and T3 was significantly (p < 0.05) lower than bucks on control T4. Lipid peroxidation level was significantly (p < 0.05) lower in bucks on T2, T3 and T4 than those bucks on the control.

Conclusion
The administration of ascorbic acid, sodium bicarbonate and its combination had enhanced seminal total antioxidant and reduced lipid peroxidation in heat-stressed bucks.
Assessment of intraepidermal nerve fiber density and neurophysiological studies in patients with idiopathic polyneuropathy
Authors: Metwally Nabiel Abd Elhakeem , Hasan Mahmoud Mohamad , Abd Elaziz Abd Elaziz Shokry , Elhadad Ali Farrag , Ibraheem Kamal Shabaan , Ali Mohammed Ahmed Ahmed , Elsalam Hesham Atif Abd 
Published: December 2022

Abstract
Background
Idiopathic polyneuropathy is an asymmetrical, length-dependent neuropathy in which neurophysiology demonstrates axonal damage involving large fibers, along with insidious onset and slow progression over 6 months, with no identified etiology in spite of thorough investigations. This study aimed to evaluate the diagnostic role of clinical, electrophysiological, and histopathological studies in patients with idiopathic polyneuropathy.

Methods
Case–control study included 20 patients with clinical and neurophysiological evidence of sensory or sensory–motor neuropathy with no apparent etiology after laboratory investigation were recruited from 127 patients with sensory–motor neuropathy of unknown etiology (the patients group). Twenty apparently healthy individuals, age- and sex-matched, with no neuropathy symptoms (the control group), were recruited from the Neurology Clinic of Al-Azhar University, Assuit.

Results
Age of onset of patients with idiopathic polyneuropathy (44–70) years, duration of illness (1–6) years, 60% had painful neuropathy, diagnostic neuropathic pain questioner (DN4 score) (5–7), abnormal pin brick (80%), abnormal vibration (90%), abnormal fine touch (75%), distal weakness (70%), and lost ankle reflex (90%). In the control group, there were substantial differences with respect to prolonged latency, diminished sympathetic skin response amplitude, and significant intraepidermal nerve fiber density reduction in skin biopsy cases. In diagnosing idiopathic polyneuropathy, the specificity and sensitivity of sympathetic skin response were (80–86)% and (81–89.5)%, respectively, whereas those of diminished intraepidermal nerve fiber density were (92.5%) and (97.5%), respectively.

Conclusion
The assessment of intraepidermal nerve fiber density had an important good diagnostic role in cases presented with polyneuropathy.
Postconditioning with lactate-enriched blood in ST-segment elevation myocardial infarction
Authors: Koyama Takashi , Akima Takashi 
Published: December 2022

Abstract
Background
Ischemic postconditioning failed to demonstrate improved outcomes in patients with ST-segment elevation myocardial infarction (STEMI) in large-scale studies. We examined the cardioprotective effects of a modified postconditioning protocol, which was named postconditioning with lactate-enriched blood (PCLeB).

Methods
This study included 100 consecutive patients with STEMI treated in the Saitama Municipal Hospital within 12 h of symptom onset since March 2014 to July 2020 with one-year follow-up. PCLeB was implemented at the beginning of reperfusion. PCLeB comprised intermittent reperfusion and timely coronary injections of lactated Ringer’s solution, aimed at achieving controlled reperfusion with myocardial oxygenation and minimal washout of lactate to prolong tissue acidosis in comparison with the original protocol. Outcome measures were in-hospital and one-year mortality and re-hospitalization rates for heart failure within one year.

Results
In-hospital and one-year mortality were zero and none was re-hospitalized for heart failure during the one-year follow-up period among the 100 study patients.

Conclusions
PCLeB was associated with zero mortality and no re-hospitalization for heart failure at one year among 100 consecutive patients with STEMI who underwent reperfusion therapy.
CD19+CD24highCD27+ B cell and interleukin 35 as potential biomarkers of disease activity in systemic lupus erythematosus patients
Authors: Xiong Hui , Tang Zengqi , Xu Ying , Shi Zhenrui , Guo Zhixuan , Liu Xiuting , Tan Guozhen , Ai Xuechen , Guo Qing 
Published: December 2022

Abstract
Background
Systemic lupus erythematosus (SLE) is a systemic autoimmune disease that associates with aberrant activation of B lymphocytes and excessive autoantibodies. Interleukin 10 (IL-10)/interleukin 35 (IL-35) and IL-10/IL-35-producing regulatory B cells have been demonstrated to possess immunosuppressive functions during systemic lupus erythematosus. Here, we detected the proportion of CD19+CD24highCD27+ B cells as well as IL-10 and IL-35 levels in peripheral blood of SLE patients and healthy individuals, and investigated their relations with clinical features of SLE.

Methods
41 SLE patients and 25 healthy controls were recruited. The patients were divided into groups based on SLEDAI score, anti-dsDNA antibody, rash, nephritis and hematological disorder. Flow cytometry was used to detect the proportion of CD24hiCD27+ B cells. ELISA was used to detect serum levels of IL-10 and IL-35.

Results
Our results showed that the CD19+CD24highCD27+ B population was decreased in active SLE patients, and anti-correlated with the disease activity. Of note, we found significant increase of IL-10 and decrease of IL-35 in SLE patients with disease activity score > 4, lupus nephritis or hematological disorders compared to those without related clinical features.

Conclusions
Reduced CD19+CD24highCD27+ B cells expression may be involved in the pathogenesis of SLE. Moreover, we supposed that IL-35 instead of IL-10 played a crucial role in immune regulation during SLE disease.
Longitudinal analysis of the faecal microbiome in pigs fed Cyberlindnera jadinii yeast as a protein source during the weanling period followed by a rapeseed- and faba bean-based grower-finisher diet
Authors: Iakhno Stanislav , Delogu Francesco , Umu Özgün C. O. , Kjos Nils P. , Håkenåsen Ingrid M. , Mydland Liv T. , Øverland Margareth , Sørum Henning 
Published: December 2022

AbstractThe porcine gut microbiome is central to animal health and growth as well as it can be structurally or functionally reshaped by dietary interventions. The gut microbiota composition in relation to Cyberlindnera jadinii yeast as a protein source in a weanling diet was studied previously. Also, there is a mounting body of knowledge regarding the porcine gut microbiome composition in response to the use of rapeseed (Brassica napus subsp. napus) meal, and faba beans (Vicia faba) as protein sources during the growing/finishing period. However, there is limited data on how the porcine gut microbiome respond to a combination of C. jadinii yeast in the weanling phase and rapeseed meal and faba beans in the growing/finishing phase. This work investigated how the porcine faecal microbiome was changing in response to a novel yeast diet with a high inclusion of yeast proteins (40% of crude protein) in a weanling diet followed by a diet based on rapeseed meal and faba beans during the growing/finishing period. The faecal microbiomes of the weanling pigs fed yeast were more diverse with higher relative abundance of Firmicutes over Bacteroidetes compared with those of soybean meal-based diet fed weanlings. Reduced numbers of Prevotella in the yeast fed faecal microbiomes remained a microbiome characteristic up until two weeks after the yeast diet was changed to the rapeseed/faba bean growing finishing diet. A number of differentially abundant bacterial phylotypes along with distinct co-occurrence patterns observed during the growing/finishing period indicated the presence of a “carry-over” effect of the yeast weanling diet onto the faecal microbiomes of the grower/finisher pigs.
Quantifying implementation strategy and dissemination channel preferences and experiences for pain management in primary care: a novel implementer-reported outcome
Authors: Ashcraft Laura Ellen , Moon Deborah J. , Merlin Jessica S. , Eack Shaun M. , Rogal Shari S. 
Published: December 2022

Abstract
Background
Precision implementation science requires methods to evaluate and select implementation strategies. This study developed and evaluated a novel measure of concordance between current and preferred dissemination channels (DC) and implementation strategies (IS) to guide efforts to improve the adoption of evidence-based management strategies for chronic pain.

Methods
We conducted a one-time electronic survey of Pennsylvania primary care practitioners (PCPs) about current vs. preferred chronic pain management DC and IS use. Survey items were selected based on preliminary data, the Model for Dissemination of Research, and the Evidence-Based Recommendations for Implementing Change taxonomy of implementation strategies. We used Cohen’s kappa (κ) to assess the agreement between participant-level current and preferred DC/IS. We calculated % preferred minus % experienced for each DC/IS and assessed the equality of proportions to determine whether this difference significantly departed from zero. We categorized DC and IS based on the degree of use and preference, to evaluate alignment.

Results
The current sample included 101 Pennsylvania PCPs primarily in urban (94.06%), non-academic (90.10%) settings who self-identified as mostly female (66.34%) and white (85.15%). The greatest difference between preferred and experienced DCs, or “need,” was identified by participants as workshops, clinical experts, seminars, and researchers. Similarly, participants reported the greatest IS gaps as multidisciplinary chronic pain workgroups, targeted support for clinicians, and a chronic pain clinical champion. Participating PCPs had moderate DC concordance (kappa = 0.45, 95% CI = 0.38–0.52) and low IS concordance (kappa = 0.18, 95% CI = 0.13–0.23). DC and IS concordance were both greater than that expected by chance. We further identified well-aligned DC and IS, including professional organizations, briefs, and guidelines.

Conclusion
We identified a novel implementer-reported outcome of dissemination channel and implementation strategy concordance that allows implementation scientists to quantify the magnitude of the gap between the current and preferred experience of implementers. This quantitative measure can help with the selection and evaluation of dissemination channels and implementation strategies. Future research should leverage this measure to understand the degree to which preference concordance influences clinical outcomes and performance.
Support vector regression-bald eagle search optimizer-based hybrid approach for short-term wind power forecasting
Authors: Amroune Mohammed 
Published: December 2022

AbstractWind power forecasting deals with the prediction of the expected generation of wind farms in the next few minutes, hours, or days. The application of machine learning techniques in wind power forecasting has become of great interest due to their superior capability to perform regression, classification, and clustering. Support vector regression (SVR) is a powerful and suitable forecasting tool that has been successfully used for wind power forecasting. However, the performance of the SVR model is extremely dependent on the optimal selection of its hyper-parameters. In this paper, a novel forecast model based on hybrid SVR and bald eagle search (BES) is proposed for short-term wind power forecasting. In the proposed model, the BES algorithm, which is characterized by a few adjustable parameters, a simplified search mechanism, and accurate results, is used to enhance the accuracy of the forecasted output by optimizing the hyper-parameters of the SVR model. To evaluate the performance of the developed wind power forecaster, a case study has been conducted on real wind power data from Sotavento Galicia in Spain. The developed model is compared to other forecasting techniques such as decision tree (DT), random forest (RF), traditional SVR, hybrid SVR, and gray wolf optimization algorithm (SVR–GWO) and hybrid SVR and manta ray foraging optimizer (SVR–MRFO). Obtained results uncovered that the proposed hybrid SVR−BES is more accurate than other methods.
Impact of the COVID-19 pandemic on physical therapy practice in Saudi Arabia
Authors: Elsayed Walaa , Albagmi Faisal , Hussain Mehwish , Alghamdi Mohammed , Farrag Ahmed 
Published: December 2022

PurposeThe new Coronavirus (COVID-19) pandemic has caused significant impact on the medical sector worldwide, including physical therapy (PT). The purpose of this study was to investigate the impact of the COVID-19 pandemic on the PT services, and the associated psychological distress endured by PT practitioners in Saudi Arabia.MethodsA cross-sectional study was conducted to survey on-duty PT practitioners using a web-based questionnaire. Licensed PT practitioners working in Saudi Arabia (n = 265) participated and completed all the survey questions. The questionnaire comprised 30 questions covering the sociodemographic data and the outcome measures, which included the impact of the pandemic on the PT practice, use of telerehabilitation, administrative response during the pandemic, and PT practitioners’ anxiety measured by the General Anxiety Disorder-7 scale.ResultsDuring the lockdown, disruptive impact on the PT practice was reported by most of the participants (80%). The majority of PT clinics/departments were either partially (43.8%) or completely (31.3%) shutdown, and therapists treated patients less than usual. Around 30% of participants reported using a telerehabilitation approach during the pandemic to communicate with patients, and about 33% received online courses and webinars to adapt the PT practice in response to the pandemic. About 21% of participants endured moderate to severe levels of anxiety, which was more pronounced among females.ConclusionThe COVID-19 pandemic significantly impacted the PT services in Saudi Arabia. Consequently, the number of patients treated was reduced, and therapists suffered notable psychological stress. Furthermore, although implemented, adaptive administrative measures were inadequate. Physical therapy practitioners and administrative authorities are encouraged to prioritize training and implementation of telerehabilitation as a likely prospective approach of PT practice.
„Wir haben keinen Plan B“
Authors: Simon Hendrik , Brinkmann Ulrich , Paulitz Tanja 
Published: December 2022

ZusammenfassungDer Beitrag argumentiert, dass hinter der Implementierung digitaler Technologien in Großunternehmen oftmals alte Interessenkonflikte stehen, die im Zuge der Digitalisierung verschärft und auf neue Felder verlagert werden. In der dichten Beschreibung eines durch teilnehmende Beobachtung begleiteten Implementierungsprozesses wird die Chronik einer gescheiterten Digitalisierung rekonstruiert. Dabei verweisen wir auf konkurrierende Interessen im Kampf um das Regulierungsniveau der Digitalisierung ebenso wie auf innerbetriebliche Strategien, die angewendet werden, um das sich abzeichnende Scheitern des Implementierungsprozesses zu verschleiern: Weil die neue digitale Technik von den Beschäftigten boykottiert wird, errichtet die verantwortliche Steuerungsgruppe „Top-down“-Fassaden, um die Digitalisierung unternehmensintern dennoch als Erfolg zu verkaufen. Paradoxerweise provoziert aber gerade diese Legitimationsstrategie einen Fassadenbau auch aufseiten der Beschäftigten „bottom-up“. Die organisationsethnografische Fallstudie macht damit eine Vielfalt lokaler Rationalitäten im innerbetrieblichen Digitalisierungskonflikt jenseits des eindeutigen Digitalisierungsdiskurses auf den Vorderbühnen des Unternehmens sichtbar.