bluuebunny/crossref_metadata_2025_split huggingface dataset:
Optical coherence tomography: evaluating the effects of stent boost subtract imaging on stent underexpansion in STEMI patients
Authors: Duan Yuanyuan , Jing Limin , Pan Shi , Yan Sujuan , Wang Fang , Yu Hong , Zhang Beibei , Wei Guangsheng , Zhang Ming , Zhang Jiao 
Published: February 2022

Abstract
Background
To evaluate the effect of stent boost subtract (SBS) imaging on stent underexpansion during percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI) by optical coherence tomography (OCT).

Methods
One hundred thirty-eight STEMI patients who underwent drug-eluting stent (DES) implantation were prospectively recruited and divided into the SBS group (69 cases) and the CAG group (69 cases) according to whether SBS was used to guide PCI. Finally, OCT was performed on all enrolled patients, and the OCT results were used as the gold standard to evaluate the impact of standard SBS technology on stent underexpansion immediately after DES implantation.

Results
SBS identified 51 patients (24%) with stent underexpansion while OCT identified 56 patients (27.2%). SBS has a sensitivity of 80%, a specificity of 96%, a positive predictive value of 88%, and a negative predictive value of 93% for identifying stent underexpansion.

Conclusion
Compared with OCT, SBS technology is a rapid stent imaging evaluation method that can accurately quantify the stent expansion level and is time-saving and economical.
Adaptive treatment allocation and selection in multi-arm clinical trials: a Bayesian perspective
Authors: Arjas Elja , Gasbarra Dario 
Published: February 2022

Abstract
Background
Adaptive designs offer added flexibility in the execution of clinical trials, including the possibilities of allocating more patients to the treatments that turned out more successful, and early stopping due to either declared success or futility. Commonly applied adaptive designs, such as group sequential methods, are based on the frequentist paradigm and on ideas from statistical significance testing. Interim checks during the trial will have the effect of inflating the Type 1 error rate, or, if this rate is controlled and kept fixed, lowering the power.

Results
The purpose of the paper is to demonstrate the usefulness of the Bayesian approach in the design and in the actual running of randomized clinical trials during phase II and III. This approach is based on comparing the performance of the different treatment arms in terms of the respective joint posterior probabilities evaluated sequentially from the accruing outcome data, and then taking a control action if such posterior probabilities fall below a pre-specified critical threshold value. Two types of actions are considered: treatment allocation, putting on hold at least temporarily further accrual of patients to a treatment arm, and treatment selection, removing an arm from the trial permanently. The main development in the paper is in terms of binary outcomes, but extensions for handling time-to-event data, including data from vaccine trials, are also discussed. The performance of the proposed methodology is tested in extensive simulation experiments, with numerical results and graphical illustrations documented in a Supplement to the main text. As a companion to this paper, an implementation of the methods is provided in the form of a freely available R package ’barts’.

Conclusion
The proposed methods for trial design provide an attractive alternative to their frequentist counterparts.
A novel graphical evaluation of agreement
Authors: Kim Jongphil , Lee Ji-Hyun 
Published: February 2022

Abstract
Background
The Bland-Altman plot with the limits of agreement has been widely used as an absolute index for assessing test-retest reliability or reproducibility between two measurements. We have observed that in the settings where the relative index such as concordance correlation coefficient (CCC) or intraclass correlation coefficient is employed, the limits of agreement approach may be inconsistent with the scaled index. Particularly, the broad width of the limits of agreement may indicate a lack of agreement when the two measurements are highly concordant but an acceptable difference is not known and the common variance of the data is large. This research aims to create a novel, CCC-based guidance for graphical evaluation of reproducibility or reliability.

Methods
The concordance correlation coefficient is used to create a 100(1-α)% reference band from two measurements. Simulation studies and real examples, including the peak expiratory flow rate data in Bland and Altman’s paper and the test-retest reproducibility data of the Radiomics study, are implemented to assess the use of the reference band.

Results
In the absence of an acceptable difference between measurements, we found that the limits of agreement may not be consistent with the concordance correlation coefficient. Our simulation study results and real data application show that the proposed method can provide practitioners with a novel graphical evaluation that is consistent with results from the concordance correlation coefficient.

Conclusions
Our proposed novel scaled index-based guidance can be used for the graphical evaluation of reproducibility or reliability and may have advantages over the limits of agreement in settings where the concordance correlation coefficient is employed.
No axillary surgical treatment for lymph node-negative patients after ultra-sonography [NAUTILUS]: protocol of a prospective randomized clinical trial
Authors: Jung Ji Gwang , Ahn Se Hyun , Lee Seeyoun , Kim Eun-Kyu , Ryu Jai Min , Park Seho , Lim Woosung , Jung Yong Sik , Chung Il Yong , Jeong Joon , Chang Ji Hyun , Shin Kyung Hwan , Chang Jung Min , Moon Woo Kyung , Han Wonshik 
Published: February 2022

Abstract
Background
Following sentinel lymph node biopsy (SLNB), the axillary recurrence rate is very low although SLNB has a false-negative rate of 5–10%. In the ACOSOG Z0011 trial, non-sentinel positive-lymph nodes were found in more than 20% of the axillary dissection group; the SLNB only group did not have a higher axillary recurrence rate. These findings raised questions about the direct therapeutic effect of the SLNB. SLNB has post-surgical complications including lymphedema. Considering advances in imaging modalities and adjuvant therapies, the role of SLNB in early breast cancer needs to be re-evaluated.

Methods
The NAUTILUS trial is a prospective multicenter randomized controlled trial involving clinical stage T1–2 and N0 breast cancer patients receiving breast-conserving surgery. Axillary ultrasound is mandatory before surgery with predefined imaging criteria for inclusion. Ultrasound-guided core needle biopsy or needle aspiration of a suspicious node is allowed. Patients will be randomized (1:1) into the no-SLNB (test) and SLNB (control) groups. A total of 1734 patients are needed, considering a 5% non-inferiority margin, 5% significance level, 80% statistical power, and 10% dropout rate. All patients in the two groups will receive ipsilateral whole-breast radiation according to a predefined protocol. The primary endpoint of this trial is the 5-year invasive disease-free survival. The secondary endpoints are overall survival, distant metastasis-free survival, axillary recurrence rate, and quality of life of the patients.

Discussion
This trial will provide important evidence on the oncological safety of the omission of SLNB for early breast cancer patients undergoing breast-conserving surgery and receiving whole-breast radiation, especially when the axillary lymph node is not suspicious during preoperative axillary ultrasound.

Trial registration
ClinicalTrials.gov, NCT04303715. Registered on March 11, 2020.
Dynamic contrast-enhanced MRI in malignant pleural mesothelioma: prediction of outcome based on DCE-MRI measurements in patients undergoing cytotoxic chemotherapy
Authors: Vivoda Tomšič Martina , Korošec Peter , Kovač Viljem , Bisdas Sotirios , Šurlan Popovič Katarina 
Published: February 2022

Abstract
Background
The malignant pleural mesothelioma (MPM) response rate to chemotherapy is low. The identification of imaging biomarkers that could help guide the most effective therapy approach for individual patients is highly desirable. Our aim was to investigate the dynamic contrast-enhanced (DCE) MR parameters as predictors for progression-free (PFS) and overall survival (OS) in patients with MPM treated with cisplatin-based chemotherapy.

Methods
Thirty-two consecutive patients with MPM were enrolled in this prospective study. Pretreatment and intratreatment DCE-MRI were scheduled in each patient. The DCE parameters were analyzed using the extended Tofts (ET) and the adiabatic approximation tissue homogeneity (AATH) model. Comparison analysis, logistic regression and ROC analysis were used to identify the predictors for the patient’s outcome.

Results
Patients with higher pretreatment ET and AATH-calculated Ktrans and ve values had longer OS (P≤.006). Patients with a more prominent reduction in ET-calculated Ktrans and kep values during the early phase of chemotherapy had longer PFS (P =.008). No parameter was identified to predict PFS. Pre-treatment ET-calculated Ktrans was found to be an independent predictive marker for longer OS (P=.02) demonstrating the most favourable discrimination performance compared to other DCE parameters with an estimated sensitivity of 89% and specificity of 78% (AUC 0.9, 95% CI 0.74-0.98, cut off > 0.08 min-1).

Conclusions
In the present study, higher pre-treatment ET-calculated Ktrans values were associated with longer OS. The results suggest that DCE-MRI might provide additional information for identifying MPM patients that may respond to chemotherapy.
Comparison of clinical characteristics between chronic bronchitis and non-chronic bronchitis in patients with chronic obstructive pulmonary disease
Authors: Choi Joon Young , Yoon Hyoung Kyu , Lee Sang Yeub , Kim Jin Woo , Choi Hye Sook , Kim Yu-Il , Jung Ki-Suck , Yoo Kwang Ha , Kim Woo Jin , Rhee Chin Kook 
Published: February 2022

Abstract
Background
Chronic bronchitis (CB) is associated with poor outcomes in patients with chronic obstructive pulmonary disease. The aim of this study was to identify the characteristics that distinguish chronic bronchitis (CB) from non-CB. In addition, the features of mild CB versus severe CB were compared and a cut-off level was defined according to CAT1 and CAT2 scores.

Methods
This study was based on the Korea COPD Subgroup Study (KOCOSS) database, constructed in a multicenter COPD cohort study that recruited patients from 54 centers. CB was defined as CAT1 and CAT2 scores ≥ 3; severe CB was defined as CAT1 and CAT2 scores ≥ 4, while mild CB was defined as either a CAT1 or a CAT2 score < 4. Baseline characteristics, 1-year exacerbation rate, and 3-year FEV1 decline were compared in non-CB versus CB patients and in patients with mild CB versus severe CB.

Results
Among the 2162 patients enrolled in this study, 497 (23%) had CB. These patients were more likely than non-CB patients to be current smokers; they also had higher symptom and depression/anxiety scores. Lung function tests showed lower FEV1, FEV1/FVC, and DLco values in CB patients. Among CB patients, 67.6% had mild disease. Symptom and depression/anxiety scores were worse in patients with severe CB than in patients with mild CB. There were no significant differences in the lung function tests of the two groups. Analysis of 1-year exacerbation rates in CB patients and non-CB patients revealed that patients with CB more frequently had moderate-to-severe exacerbations (OR = 1.46, p < 0.01). More severe exacerbation was also present in patients with severe CB than in patients with mild CB (OR = 2.52, p = 0.01). The difference in annual FEV1 decline rate did not significantly differ either between CB patients and non-CB patients or between patients with severe CB and patients with mild CB.

Conclusions
CB patients had worse symptoms and lung function than non-CB patients; CB patients also had more frequent moderate-to-severe exacerbation. Patients with severe CB had higher symptom scores and more frequent severe exacerbation than did patients with mild CB.
Fertility awareness and subclinical infertility among women trying to get pregnant at home
Authors: Iino Kaori , Fukuhara Rie , Yokota Megumi , Yokoyama Yoshihito 
Published: February 2022

Abstract
Background
Recent studies on fertility awareness among the reproductive population have reported the lack of accurate knowledge about fertility and assisted reproductive technologies. However, there has been little information regarding women trying to get pregnant at home. The aim of this study was to explore the prevalence of subclinical infertility among women trying to get pregnant at home, and to evaluate awareness regarding infertility and reasons for not visiting infertility clinics among women who use pregnancy-assist mobile applications to help them conceive.

Methods
A total of 2084 Japanese women responded to this online survey. We selected 1541 women according to the study criteria. Based on the results of 61 questions, we evaluated knowledge regarding fertility, prevalence of subclinical infertility, and reasons for not visiting the clinic among the participants.

Results
Despite the desire to conceive, the participants had an apparent tendency to overestimate the age limit for childbearing. A total of 338 (21.9%) women answered that in general women aged > 45 years could get pregnant. Approximately 40% of the women had possible subclinical infertility and were unaware of the fact. Additionally, about 70% of the women considered themselves to have infertility problems. Women who were aware of the possibility of infertility hesitated to visit the clinic due to unfamiliarity with a gynecologist or clinic, and apprehensions about the gynecologic examination.

Conclusions
In our study, some women required treatment for infertility. Nonetheless, they hesitated to visit an infertility clinic. Sexual health education, together with proper accessibility to gynecology clinics, are necessary to reduce involuntary childlessness.
Insulin resistance induced by de novo pathway–generated C16-ceramide is associated with type 2 diabetes in an obese population
Authors: Chathoth Shahanas , Ismail Mona H. , Alghamdi Hanan M. , Zakaria Hazem Mohamed , Hassan Khairi Ahmed , Alshomimi Saeed , Vatte Chittibabu , Cyrus Cyril , Alsaif Hind S. , Mostafa Ahmed , Shaaban Heba , Al Ali Amein 
Published: February 2022

Abstract
Background
Obesity and diabetes are two chronic metabolic diseases whose prevalence is increasing at an alarming rate globally. A close association between obesity, diabetes, and insulin resistance has been identified, and many studies have pinpointed obesity as a causal risk factor for insulin resistance. However, the mechanism underlying this association is not entirely understood. In the past decade, ceramides have gained attention due to their accumulation in certain tissues and their suggested role in initiating insulin resistance. This study aims to determine the association of specific ceramides and their major metabolizing enzymes with obesity-associated insulin resistance.

Methods
The samples comprised subcutaneous adipose tissues collected from three cohorts: lean non-diabetic (controls; n = 20), obese-non-diabetic (n = 66), and obese-diabetic (n = 32). Ceramide levels were quantified using LC-MS/MS and mRNA expression level for different enzymes were estimated using real-time PCR-based RNA expression analysis.

Results
C16-ceramide (P = 0.023), C16-dihydro-ceramide (P < 0.005), C18-dihydro-ceramide (P = 0.009) and C24-ceramide (P = 0.040) levels were significantly increased in the obese cohort compared to the control group. However, stratification of the obese group revealed a significant increase in the C16-ceramide levels (P = 0.027) and mRNA over expression of the serine palmitoyl transferases enzyme subunit SPT1 (P < 0.005) in the obese-diabetic cohort compared to the obese-non-diabetic cohort.

Conclusions
The present study indicates that C16-ceramide plays a pivotal role in inducing insulin resistance. Overexpression of SPT1 in the obese-diabetic group and its positive correlation with C16-ceramide suggest that C16-ceramide was generated through the de novo pathway.
Segmentation of structural parts of rosebush plants with 3D point-based deep learning methods
Authors: Turgut Kaya , Dutagaci Helin , Galopin Gilles , Rousseau David 
Published: February 2022

Abstract
Background
Segmentation of structural parts of 3D models of plants is an important step for plant phenotyping, especially for monitoring architectural and morphological traits. Current state-of-the art approaches rely on hand-crafted 3D local features for modeling geometric variations in plant structures. While recent advancements in deep learning on point clouds have the potential of extracting relevant local and global characteristics, the scarcity of labeled 3D plant data impedes the exploration of this potential.

Results
We adapted six recent point-based deep learning architectures (PointNet, PointNet++, DGCNN, PointCNN, ShellNet, RIConv) for segmentation of structural parts of rosebush models. We generated 3D synthetic rosebush models to provide adequate amount of labeled data for modification and pre-training of these architectures. To evaluate their performance on real rosebush plants, we used the ROSE-X data set of fully annotated point cloud models. We provided experiments with and without the incorporation of synthetic data to demonstrate the potential of point-based deep learning techniques even with limited labeled data of real plants.

Conclusion
The experimental results show that PointNet++ produces the highest segmentation accuracy among the six point-based deep learning methods. The advantage of PointNet++ is that it provides a flexibility in the scales of the hierarchical organization of the point cloud data. Pre-training with synthetic 3D models boosted the performance of all architectures, except for PointNet.
Internal fixation using fully threaded cannulated compression screws for fresh femoral neck fractures in adults
Authors: Yuan Kai-xuan , Yang Fan , Fu Kai , Zhu Dao-yu , Jiang Chen-yi , Jin Dong-xu , Wang Ze-hao , Peng Xiao-yuan , Gao You-Shui , Luo Peng-bo 
Published: February 2022

Abstract
Objectives
Internal fixation with multiple cannulated compression screws is an optional treatment for femoral neck fracture. Recently, fully threaded cannulated compression screws (FTCCS) have been introduced to fix fresh femoral neck fractures (FNF). The purpose of this study was to investigate the effectiveness of FTCCS.

Patients and methods
Patients with FNF fixed by multiple FTCCS from February 1st, 2014 to August 31st, 2017 were included in this study. They were followed for at least 12 months postoperatively. Nonunion, osteonecrosis of the femoral head (ONFH), fixation failure, reoperation, and femoral neck shortening (FNS) were used to evaluate the outcomes. Risk factors including age, sex, fracture side, fracture displacement, fracture stability, fixation configuration, and screw numbers were analyzed.

Results
A total of 113 patients including 67 males and 46 females with an average age of 48.4 ± 13.4 years were included. The mean duration of follow-up was 27.1 months (range: 12–51 months). The incidence of nonunion, ONFH, fixation failure, and reoperation was 15.9%, 22.1%, 8.8%, and 24.8%, respectively. The rates of nonunion and reoperation were significantly higher in displaced fractures and unstable fractures. And patients with an unstable fracture had a higher risk of internal fixation failure. The median length of FNS was 2.9 mm (interquartile range: 0.9–6.5 mm, range: 0–17.5 mm). Age was a significant risk factor for FNS.

Conclusions
The screw fixation method with FTCCS provided encouraging clinical results which may be a rational choice for the treatment of fresh FNF. Displaced fractures and unstable fractures were attributed to the higher incidence of complications.
Trial registration: ChiCTR, ChiCTR1800017200. Registered 17 July 2018-Retrospectively registered, http: www.chictr.org.cn/showprojen.aspx?proj=29182.
Clinical and quality-of-life outcomes of a combined synthetic scaffold and autogenous tissue graft procedure for articular cartilage repair in the knee
Authors: Rosa Fernando Martins , Fernandes Julio Cesar , Delisle Josée , Ranger Pierre , Albano Mauro Batista , Filho Edmar Stieven 
Published: February 2022

Abstract
Background
Injuries to the articular cartilage of the knee often fail to heal properly due to the hypocellular and avascular nature of this tissue. Subsequent disability can limit participation in sports and decrease quality of life. Subchondral bone perforations are used for the treatment of small defects. Filling out the central portion in larger lesions becomes difficult, and scaffolds can be used as adjuvants, providing a matrix onto which the defect can be filled in completely. Also, autogenous cartilage grafts can be combined, acting as an inducer and improving healing quality, all in a single procedure.

Methods
This observational study evaluated the clinical and quality-of-life outcomes of patients with articular cartilage lesions of the knee undergoing repair via a microfracture technique combined with a synthetic scaffold and autogenous cartilage graft, with transosseous sutures and fibrin glue fixation, at 12 months of follow-up. Secondarily, it assessed whether combined procedures, previous surgical intervention, traumatic aetiology, lesion location, and age affect outcomes. The sample consisted of adult patients (age 18–66 years) with symptoms consistent with chondral or osteochondral lesions, isolated or multiple, ICRS grade III/IV, 2–12 cm2 in size. Patients with corrected angular deviations or instabilities were included. Those with BMI > 40 kg/m2, prior total or subtotal (> 30%) meniscectomy, second-look procedures, and follow-up < 6 months were excluded. Pain (VAS), physical activity (IKDC), osteoarthritis (WOMAC), and general quality of life (SF-36) were assessed.

Results
64 procedures were included, comprising 60 patients. There was significant improvement (P < 0.05) in VAS score (5.92–2.37), IKDC score (33.44–56.33), and modified WOMAC score (53.26–75.93) after surgery. The SF-36 showed significant improvements in the physical and mental domains (30.49–40.23 and 46.43–49.84 respectively; both P < 0.05).

Conclusions
Combination of microfractures, autogenous crushed cartilage graft, synthetic scaffold, and transosseous sutures with fibrin glue provides secure fixation for treatment of articular cartilage lesions of the knee. At 12-month follow-up, function had improved by 20 points on the IKDC and WOMAC, and quality of life, by 10 points on the SF-36. Age > 45 years had a negative impact on outcomes.