bluuebunny/crossref_metadata_2025_split huggingface dataset:
Ratio of carbon dioxide veno-arterial difference to oxygen arterial-venous difference is not associated with lactate decrease after fluid bolus in critically ill patients with hyperlactatemia: results from a prospective observational study
Authors: Kaefer Keitiane , Pierrakos Charalampos , Nguyen Thomas , Velissaris Dimitrios , Attou Rachid , Devriendt Jacques , Scolletta Sabino , Taccone Fabio Silvio 
Published: January 2023

Abstract
Background
High ratio of the carbon dioxide veno-arterial difference to the oxygen arterial-venous difference (PvaCO2/CavO2) is associated with fluid bolus (FB) induced increase in oxygen consumption (VO2). This study investigated whether PvaCO2/CavO2 was associated with decreases in blood-lactate levels FB in critically ill patients with hyperlactatemia.

Methods
This prospective observational study examined adult patients in the intensive care unit (ICU) with lactate levels > 1.5 mmol/L who received FBs. Blood-lactate levels were measured before and after FB under unchanged metabolic, respiratory, and hemodynamic conditions. The primary outcome was blood-lactate levels after FB. Significant decreases in blood-lactate levels were considered as blood-lactate levels < 1.5 mmol/L or a decrease of more than 10% compared to baseline.

Results
The study enrolled 40 critically ill patients, and their median concentration of blood lactate was 2.6 [IQR:1.9 − 3.8] mmol/L. There were 27 (68%) patients with PvaCO2/CavO2 ≥ 1.4 mmHg/ml, and 10 of them had an increase in oxygen consumption (dVO2) ≥ 15% after FB, while 13 (32%) patients had PvaCO2/CavO2 < 1.4 mmHg/ml before FB, and none of them had dVO2 ≥ 15% after FB. FB increased the cardiac index in patients with high and low preinfusion PvaCO2/CavO2 (13.4% [IQR: 8.3 − 20.2] vs. 8.8% [IQR: 2.9 − 17.4], p = 0.34). Baseline PvaCO2/CavO2 was not found to be associated with a decrease in blood lactate after FB (OR: 0.88 [95% CI: 0.39 − 1.98], p = 0.76). A positive correlation was observed between changes in blood lactate and baseline PvaCO2/CavO2 (r = 0.35, p = 0.02).

Conclusions
In critically ill patients with hyperlactatemia, PvaCO2/CavO2 before FB cannot be used to predict decreases in blood-lactate levels after FB. Increased PvaCO2/CavO2 is associated with less decrease in blood-lactate levels.
Multivariate decomposition of gender differentials in successful aging among older adults in India
Authors: Srivastava Shobhit , Muhammad T. , Paul Ronak , Khan Kacho Amir 
Published: January 2023

Abstract
Background
Rowe and Kahn define successful aging as a high physical, psychological, and social functioning in old age without major diseases. It is considered a viable solution to the burdens placed on healthcare systems and financial and social security in societies with aging population. The present study aimed to determine the prevalence of successful aging and explore the factors contributing to gender differentials in successful aging among older adults in India.

Methods
This study utilized data from the nationally representative Longitudinal Ageing Study in India, conducted in 2017–18. The study is based on a sample of 15,098 older men and 16,366 older women aged 60 years and above. The outcome variable was a dichotomous measure of successful aging with six components including absence of chronic diseases, free from disability, high cognitive ability, free from depressive symptoms, active social engagement in life and free from obesity. Older adults satisfying all these conditions were considered aging successfully. Descriptive and bivariate analyses were carried out. Proportion test was used to evaluate the gender differentials and reflect the statistical significance in the associated factors. Multivariate decomposition analysis was conducted to identify covariates’ contribution in explaining the gender differences in successful aging.

Results
There was a significant gender difference in successful aging among older adults in India (Difference: 8.7%; p-value < 0.001] with 34.3% older men and 25.6% older women experiencing successful aging. A proportion of 88% of gender difference in successful aging was explained by the differences in the distribution of characteristics (Coef: 0.082; p-value < 0.05). Considerable gender gap in successful aging would be reduced if women had similar levels of work status (28% reduction) to their male counterparts. Bringing the level of frequent physical activity in women to the same levels observed in men would reduce the gender gap by 9%.

Conclusions
The findings suggest that women had a lower score in successful aging, which is attributed to several socioeconomic and behavioural factors including not working status and physical inactivity. More studies must be done to explore the reasons for such differences and what particular factors in low-income countries create differences among older men and women in achieving successful aging.
Protocol for a confirmatory trial of the effectiveness and safety of palliative arterial embolization for painful bone metastases
Authors: Zenda Sadamoto , Arai Yasunori , Sugawara Shunsuke , Inaba Yoshitaka , Hashimoto Kazuki , Yamamoto Kouji , Saigusa Yusuke , Kawaguchi Takashi , Shimada Sanae , Yokoyama Marie , Miyaji Tempei , Okano Tomoka , Nakamura Naoki , Kobayashi Eisuke , Takagi Tatsuya , Matsumoto Yoshihisa , Uchitomi Yosuke , Sone Miyuki ,   for the J-SUPPORT 1903, PALEM Trial
Published: January 2023

Abstract
Background
Transcatheter arterial embolization (TAE) has long been used for hemostasis of traumatic or postoperative hemorrhage and embolization of tumors. Previous retrospective studies of TAE for painful bone metastases showed 60%–80% pain reduction with a median time to response of 1–2 days. Compared with radiotherapy and bisphosphonates, time to response appeared earlier than that of radiotherapy or bone-modifying agents. However, few prospective studies have examined TAE for this indication. Here, we describe the protocol for a confirmatory study designed to clarify the efficacy and safety profile of TAE.

Methods
This study will be a multicenter, single-arm confirmatory study (phase 2–3 design). Patients with painful bone metastases from any primary tumor are eligible for enrollment. TAE will be the main intervention. Following puncture of the femoral artery under local anesthesia and insertion of an angiographic sheath, angiography will confirm that the injected region includes tumor vasculature. Catheter position will be adjusted so that the embolization range does not include non-target tissues. Spherical embolic material will then be slowly injected into the artery to embolize it. The primary endpoint (efficacy) is the proportion of subjects with pain relief at 72 h after TAE and the secondary endpoint (safety) is the incidence of all NCI Common Terminology Criteria for Adverse Events version 5.0 Grade 4 adverse events and Grade ≥ 3 necrosis of the central nervous system.

Discussion
If the primary and secondary endpoints are met, TAE can be a treatment choice for painful bone metastases. Trial registry number is UMIN-CTR ID: UMIN000040794.

Trial registration
The study is ongoing, and patients are currently being enrolled. Enrollment started in March 2021. A total of 36 patients have participated as of Aug 2022.
Protocol Version: Ver1.4, 13/07/2022.
Using CT radiomic features based on machine learning models to subtype adrenal adenoma
Authors: Qi Shouliang , Zuo Yifan , Chang Runsheng , Huang Kun , Liu Jing , Zhang Zhe 
Published: January 2023

Abstract
Background
Functioning and non-functioning adrenocortical adenoma are two subtypes of benign adrenal adenoma, and their differential diagnosis is crucial. Current diagnostic procedures use an invasive method, adrenal venous sampling, for endocrinologic assessment.

Methods
This study proposes establishing an accurate differential model for subtyping adrenal adenoma using computed tomography (CT) radiomic features and machine learning (ML) methods. Dataset 1 (289 patients with adrenal adenoma) was collected to develop the models, and Dataset 2 (54 patients) was utilized for external validation. Cuboids containing the lesion were cropped from the non-contrast, arterial, and venous phase CT images, and 1,967 features were extracted from each cuboid. Ten discriminative features were selected from each phase or the combined phases. Random forest, support vector machine, logistic regression (LR), Gradient Boosting Machine, and eXtreme Gradient Boosting were used to establish prediction models.

Results
The highest accuracies were 72.7%, 72.7%, and 76.1% in the arterial, venous, and non-contrast phases, respectively, when using radiomic features alone with the ML classifier of LR. When features from the three CT phases were combined, the accuracy of LR reached 83.0%. After adding clinical information, the area under the receiver operating characteristic curve increased for all the machine learning methods except for LR. In Dataset 2, the accuracy of LR was the highest, reaching 77.8%.

Conclusion
The radiomic features of the lesion in three-phase CT images can potentially suggest the functioning or non-functioning nature of adrenal adenoma. The resulting radiomic models can be a non-invasive, low-cost, and rapid method of minimizing unnecessary testing in asymptomatic patients with incidentally discovered adrenal adenoma.
Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting
Authors: Pivot Xavier , Manikhas Alexey Georgievitch , Shamrai Volodymyr , Dzagnidze Giorgi , Soo Hoo Hwoei Fen , Kaewkangsadan Viriya , Petrelli Fausto , Villanueva Cristian , Kim Jamie , Pradhan Sumita , Jaison Litha , Feyaerts Peggy , Kaufman Leonard , Derde Marie-Paule , Deforce Filip , Cox David G. 
Published: January 2023

Abstract
Background
The TROIKA trial established that HD201 and trastuzumab were equivalent in terms of primary endpoints (total pathological complete response) following neoadjuvant treatment. The objective of the present analysis was to compare survival outcomes and final safety.

Methods
In the TROIKA trial, patients with ERBB2-positive early breast cancer were randomized and treated with either HD201 or the referent trastuzumab. Eligible patients received 8 cycles of either HD201 or referent trastuzumab (loading dose, 8 mg/kg; maintenance dose, 6 mg/kg) every 3 weeks in combination with 8 cycles of chemotherapy (4 cycles of docetaxel, 75 mg/m2, followed by 4 cycles of epirubicin, 75 mg/m2, and cyclophosphamide, 500 mg/m2) in the neoadjuvant setting. The patients then underwent surgery followed by 10 cycles of adjuvant HD201 or referent trastuzumab according to their initial randomization to complete one year of trastuzumab-directed therapy. Event-free and overall survival rates were calculated using Kaplan–Meier analysis. The hazard ratio for event-free survival was estimated by Cox proportional hazards regression.

Results
The final analysis was performed after all patients completed the study at a median follow-up of 37.7 months (Q1-Q3, 37.3–38.1 months). A total of 502 randomized patients received either HD201 or the referent trastuzumab, and 474 (94.2%) were eligible for inclusion in the per-protocol set. In this population, the 3-year event-free survival rates were 85.6% (95% CI: 80.28–89.52) and 84.9% (95% CI: 79.54–88.88) in the HD201 and referent trastuzumab groups, respectively (log rank p = 0.938) (HR 1.02, 95% CI: 0.63–1.63; p = 0.945). The 3-year overall survival rates were comparable between the HD201 (95.6%; 95% CI: 91.90–97.59) and referent trastuzumab treatment groups (96.0%, 95% CI: 92.45–97.90) (log rank p = 0.606). During the posttreatment follow-up period, adverse events were reported for 64 (27.4%) and 72 (29.8%) patients in the HD201 and the reference trastuzumab groups, respectively. Serious adverse events were rare and none of which were related to the study treatment.

Conclusions
This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and trastuzumab.

Trial registration
ClinicalTrials.gov identifier: NCT03013504.
Effectiveness and cost-effectiveness of MicroShunt implantation versus standard trabeculectomy for open-angle glaucoma (a SIGHT study): study protocol of a multicentre randomised controlled trial
Authors: Scheres Lotte M. J. , van den Biggelaar Frank J. H. M. , Winkens Bjorn , Kujovic-Aleksov Stefani , Müskens Rogier P. H. M. , de Waard Peter W. T. , de Crom Ronald M. P. C. , Ernest Paul J. G. , Pijl Benjamin J. , Ramdas Wishal D. , van Rijn Laurentius J. , Tan Annelie , Dirksen Carmen D. , Beckers Henny J. M. 
Published: January 2023

Abstract
Background
Trabeculectomy is the “gold standard” initial surgical procedure for open-angle glaucoma worldwide. During the last decade, the introduction of less invasive procedures, including new bleb-forming surgery such as the MicroShunt, has altered the approach of glaucoma management. At present, there is insufficient evidence comparing the effectiveness between these procedures nor versus trabeculectomy. Furthermore, there is no data available on patient impact and cost-effectiveness. This study aims to address this gap in evidence and establish whether MicroShunt implantation is non-inferior compared to trabeculectomy with regard to effectiveness and whether it is cost-effective.

Methods
A multicentre, non-inferiority, randomised controlled trial (RCT) studying open-angle glaucoma with an indication for surgery will be conducted. Patients with previous ocular surgery except for phacoemulsification are excluded, as are patients with ocular comorbidity compromising the visual field or requiring a combined procedure. After informed consent is obtained, patients will be randomly allocated to the intervention, a PRESERFLO™ MicroShunt implantation, or the control group, trabeculectomy, using block randomisation (blocks of 2, 4 or 6 patients). In total, 124 patients will be randomised in a 1:1 ratio, stratified by centre. The primary endpoint will be intraocular pressure (IOP) one year after surgery. Secondary outcomes include IOP-lowering medication use, treatment failure, visual acuity, visual field progression, additional interventions, adverse events, patient-reported outcome measures (PROMs), and cost-effectiveness. Study outcomes will be measured up to 12 months postoperatively.

Discussion
This study protocol describes the design of a multicentre non-inferiority randomised controlled trial. To this date, cost-effectiveness studies evaluating the MicroShunt have not been undertaken. This multicentre RCT will provide more insight into whether MicroShunt implantation is non-inferior compared to standard trabeculectomy regarding postoperative IOP and whether MicroShunt implantation is cost-effective.

Trial registration
ClinicalTrials.gov, Identifier: NCT03931564, Registered 30 April 2019.
Mycobacterium infection secondary to exogenous lipoid pneumonia caused by nasal drops: a case report and literature review
Authors: Wang Huihong , Lu Shan , Li Hequan , Wang Yuehong 
Published: January 2023

Abstract
Background
Exogenous lipoid pneumonia (ELP) is a rare disease and its diagnosis is often mistaken or delayed. Secondary infection with rapidly growing non-tuberculous mycobacteria is a rare complication of lipoid pneumonia.

Case presentation
A 38-year-old man presented with fever, cough, sputum, chest tightness, and shortness of breath. He had a 2-year history of allergic rhinitis and used liquid paraffin-containing menthol nasal drops daily. A chest CT scan showed multiple patchy ground glass opacities with blurred borders in both lungs, which were located in the inner pulmonary field and distributed along the bronchi. His ambient air PO2 was 63 mmHg. The patient was diagnosed with ELP by CT-guided lung biopsy. The nasal drops were discontinued, and systemic glucocorticoids were administered. During treatment, the pulmonary lesions deteriorated, and bronchoalveolar lavage was performed during bronchoscopy. Additionally, Mycobacterium abscessus was detected in the lavage fluid. Upon detection of a secondary M. abscessus infection, glucocorticoids were gradually discontinued, and anti-M. abscessus treatment was implemented. The patient’s symptoms rapidly ameliorated. After 11 months of anti-M. abscessus treatment, a repeat CT scan showed clear regression of the lung lesions.

Conclusion
Routine microbiological examination of samples, including sputum or alveolar lavage fluid, is necessary for patients with diagnosed or suspected ELP.
Analysis of the curative effect of cervical spondylotic radiculopathy with osseous foraminal stenosis using ultrasonic osteotome in anterior cervical surgery
Authors: Liu Junlin , Kong Qingquan , Feng Pin , Zhang Bin , Ma Junsong , Hu Yuan 
Published: January 2023

Abstract
Purpose
To explore the clinical efficacy and operation points of cervical radiculopathy with osseous foraminal stenosis treated with ultrasonic osteotome in anterior cervical surgery.

Methods
From January 2018 to June 2021，a retrospective analysis of 23 patients with cervical radiculopathy with bony foraminal stenosis during this period was retrospectively analyzed. Anterior Cervical Discectomy and Fusion (ACDF) was used for all cases in this group. Intraoperative use of ultrasonic osteotome to decompress the nerve in the intervertebral foramina. The operation time, intraoperative blood loss and complication rate were recorded in this group of patients. Interbody fusion was evaluated using Brantigan criteria. The IC-PACS imaging system was used to measure the intervertebral foramen area (IFA) before and after surgery to evaluate the range of decompression. The VAS (Visual Analogue Scale, VAS) score and NDI (Neck Disability Index, NDI) score before and after surgery were recorded to evaluate the clinical efficacy.

Results
All enrolled patients were followed up regularly for 1 year or more. The mean operative time was 61.5 ± 8.0 minutes. The average intraoperative blood loss was 88.3 ± 12.8 ml, and the average hospital stay was 8.1 ± 1.7d. Twenty one cases of successful fusion were followed up 1 year after operation, and the fusion rate was 91.3%. IFA expanded from 25.1 ± 4.0 mm2 before operation to 57.9 ± 3.4 mm2 at 1 year after operation, and the difference was statistically significant (P < 0.001). The VAS score and NDI score of patients 3 days after surgery, 3 months after surgery, and 1 year after surgery were significantly lower than those before surgery (P < 0.001). There was 1 case of dysphagia and 1 case of Cage subsidence after operation, and the complication rate was 8.6%.

Conclusion
Anterior cervical surgery using ultrasonic osteotome in the treatment of cervical radiculopathy with bony foraminal stenosis has reliable clinical efficacy and high safety, and is worthy of clinical promotion.
Association of hospital volume with perioperative and oncological outcomes of robot-assisted laparoscopic radical prostatectomy: a retrospective multicenter cohort study
Authors: Tatenuma Tomoyuki , Ebara Shin , Kawase Makoto , Sasaki Takeshi , Ikehata Yoshinori , Nakayama Akinori , Toide Masahiro , Yoneda Tatsuaki , Sakaguchi Kazushige , Teishima Jun , Inoue Takahiro , Kitamura Hiroshi , Saito Kazutaka , Koga Fumitaka , Urakami Shinji , Koie Takuya , Makiyama Kazuhide 
Published: January 2023

Abstract
Background
This retrospective multicenter cohort study investigated the association of hospital volume with perioperative and oncological outcomes in patients treated with robot-assisted radical prostatectomy (RARP).

Methods
We collected the clinical data of patients who underwent RARP at eight institutions in Japan between September 2012 and August 2021. The patients were divided into two groups based on the treatment site—high- and non-high-volume hospitals. We defined a high-volume hospital as one where RARP was performed for more than 100 cases per year.

Results
After excluding patients who received neoadjuvant therapy, a total of 2753 patients were included in this study. In the high-volume hospital group, console time and estimated blood loss were significantly (p < 0.001) lower than that of the non-high-volume hospital group. However, the continence rate at 3 months after RARP, positive surgical margins, and prostate-specific antigen (PSA)-relapse-free survival showed no significant differences between the two groups. Furthermore, the console time was significantly shorter after 100 cases in the non-high-volume hospital group but not in the high-volume hospital group.

Conclusions
A higher hospital volume was significantly associated with shorter console time and less estimated blood loss. However, oncological outcomes and early continence recovery appear to be comparable regardless of the hospital volume in Japan.
Biochemical characterization and insights into the potency of the acidic Aspergillus niger NRC114 purified α-galactosidase in removing raffinose family oligosaccharides from soymilk yogurt
Authors: Othman Abdelmageed M. , Elshafei Ali M. , Elsayed Maysa A. , Ibrahim Gamil E. , Hassan Mohamed M. , Mehanna Nayra S. 
Published: January 2023

Abstract
Background
Because humans lack α-galactosidase, foods containing certain oligosaccharides from the raffinose family, such as soybeans and other legumes, may disrupt digestion and cause flatulence.

Results
Aspergillus niger NRC114 α-galactosidase was purified using protein precipitation, gel filtration, and ion exchange chromatography steps, which resulted in a 123-fold purification. The purified enzyme was found to be 64 kDa using the SDS-PAGE approach. The optimum pH and temperature of the purified α-galactosidase were detected at pH 3.5 and 60 ºC, respectively. The pure enzyme exhibited potent acidic pH stability at pH 3.0 and pH 4.0 for 2 h, and it retained its full activity at 50 ºC and 60 ºC for 120 min and 90 min, respectively. The enzyme was activated using 2.5 mM of K+, Mg2+, Co2+, or Zn2+ by 14%, 23%, 28%, and 11%, respectively. The Km and Vmax values of the purified enzyme were calculated to be 0.401 µM and 14.65 μmol min−1, respectively. The soymilk yogurt showed an increase in its total phenolic content and total flavonoids after enzyme treatment, as well as several volatile compounds that were detected and identified using GC–MS analysis. HPLC analysis clarified the enzymatic action in the hydrolysis of raffinose family oligosaccharides.

Conclusion
The findings of this study indicate the importance of A. niger NRC114 α-galactosidase enzyme for future studies, especially its applications in a variety of biological fields.