bluuebunny/crossref_metadata_2025_split huggingface dataset:
Case report: An intraretinal macrocyst with crystalline content and retinal detachment
Authors: Cai Chang , Zhou Jialin , Wang Qiuyu , Li Weihou , Liu Danning 
Published: December 2022

IntroductionAn intraretinal macrocyst is a cavity located in the outer plexiform layer of the retina. It is commonly filled with liquid or blood. To date, few case reports of intraretinal macrocysts with crystalline content and retinal detachment have been published.Case presentationA 44-year-old woman with no history of other diseases complained of decreased vision in her right eye that had persisted for 20 days. The best corrected visual acuity of the right eye was hand motion. Comprehensive ophthalmic examinations were performed, including a vision test, slit lamp fundus examination, ocular B-scan ultrasound, and orbital magnetic resonance imaging. We performed vitrectomy and retinotomy to sufficiently remove the macrocyst and relieve retinal traction. We then reattached the retina and filled it with silicone oil. During the surgery, we found that the cyst had crystalline content, which has not been previously reported, to the best of our knowledge. Finally, the pathological results confirmed a final diagnosis of intraretinal macrocyst. Six months later, we performed a second operation to remove the silicone oil and implant an intraocular lens. After both surgeries, the best corrected visual acuity of the patient's right eye was restored to 20/200, and the retina had repositioned.ConclusionIntraretinal macrocysts are very rare. Both orbital magnetic resonance imaging and ocular B-scan ultrasound are essential for their diagnosis. Our results indicated that vitrectomy was the best way to remove the cyst and reattach the retina.
International oncology drug approvals for multiregional or single-country clinical trials: A systematic review
Authors: Zhang Min , Onakpoya Igho , Rupalla Katrin 
Published: December 2022

BackgroundCancer remains one of the most common causes of morbidity and mortality worldwide. Multiregional (MRCTs) and single-country clinical trials are two common approaches to support new oncology drug approvals internationally. However, systematic reviews comparing MRCTs with single-country trials for international oncology drug approval are lacking.MethodsWe searched health agency websites to retrieve all approved oncology drugs from 2010 to 2022. ClinicalTrials.gov was used to retrieve all pivotal study information. We used an adapted version 2 of the Cochrane risk-of-bias tool for randomized trials (RoB 2) and Risk Of Bias In Non-randomized Studies - of Interventions (ROBINS-I) checklist to assess the risk-of-bias in randomized and non-randomized trials, respectively.ResultsA total of 48 new drugs and biologics (comprising 215 pivotal clinical trials) with initial marketing approval in the United States, European Union, Japan, and China were included. The reporting quality of MRCTs vs. single-country studies was similar. The median time interval for approval was significantly longer for MRCTs than for single-country bridging studies (1,399 vs. 975 days, P &lt; 0.0001), whereas the median time interval for approval was shorter for MRCTs than for single-country standalone studies. The time gap for oncology drugs approved before 2015 was significantly longer than for those approved after 2015. The median timeline for approval in MRCTs involving 3 regions showed the shortest time-to-approval compared with MRCTs involving 4–5 and 1–2 regions. There was no significant difference in the time-to-approval among different tumor types and product types.ConclusionThe median time-to-approval of MRCTs was significantly longer than that of single-country bridging studies but shorter than that of single-country standalone studies, primarily involving 3 regions as the most frequent pattern and the shortest time-to-approval to operate MRCTs as a pivotal trial. Single-country bridging studies still provide essential supplements for international oncology drug approvals if MRCTs do not apply. Future studies should explore how to shorten the time-to-approval for MRCTs.Systematic review registration[https://www.researchregistry.com/browsethe-registry#registryofsystematicreviewsmeta-analyses/], identifier [1390].
Computed tomography-based assessment of radiographic progression in spine and sacroiliac joints after pregnancy in women with radiographic axial spondyloarthritis
Authors: Lee Kyung-Ann , Lee So Yun , Kim Se Hee , Kim Hyun-Sook , Kim Hae-Rim , Lee Sang-Hoon 
Published: December 2022

BackgroundMechanical stress are one of the pathogenesis of axial spondyloarthritis (axSpA). During pregnancy, the mechanical overload on the spine and pelvis increases due to gravid uterus. We aimed to investigate whether pregnancy affects radiographic progression in patients with radiographic axSpA (r-axSpA) based on computed tomography (CT) evaluations.Materials and methodsThis retrospective study included women with r-axSpA aged 19–49 years who underwent at least two CT evaluations of the whole spine and/or sacroiliac joints (SIJs) at intervals of 2–4 years. To compare radiographic progression after delivery, we classified the patients into two groups: delivery group and controls. The delivery group was restricted to women who had the first CT ∼2 years before delivery and the second CT ∼2 years after delivery. The CT Syndesmophyte Score (CTSS) (0–522) and SIJ scores (0–40) were used to evaluate spinal syndesmophytes and erosion, joint space narrowing, and sclerosis of the SIJs.ResultsA total of 21 women in the delivery group and 38 women in the control group were included. The median (Q1–Q3) CTSS at baseline in the delivery group and controls was 19 (16–23) and 20 (13.25–27.75), and the median progression was 1 (0–3) and 0 (0–1) during the median 2.9-year follow-up, respectively. The median (Q1–Q3) SIJ score at baseline in the delivery group and controls was 13 (8–22) and 11 (6–22), and the median progression was 1.5 (0–3) and 1 (0–2), respectively. Using cut-off 0.5, 52.9, and 61.9% of r-axSpA patients and 39.3 and 44.4% of controls showed progression of whole spine and SIJs, respectively. However, no difference in proportion of spinal and SIJ progression and absolute score changes per time point was observed between two groups. Moreover, the SIJ score changes were comparable according to the delivery method.ConclusionPregnancy and delivery do not affect the radiographic progression of the spine and SIJs in women with r-axSpA assessed by CT.
Can the implementation of clinical practice guidelines improve clinical competence of physicians and kidney function of patients with type 2 diabetes mellitus?
Authors: Martínez-Martínez Petra , Cueto-Manzano Alfonso M. , Cortés-Sanabria Laura , Martínez-Ramírez Héctor R. , Rojas-Campos Enrique , Hernández-Herrera Aurora 
Published: December 2022

BackgroundThere are many clinical practice guidelines (CPGs) in Nephrology; however, there is no evidence that their availability has improved the clinical competence of physicians or the outcome of patients with chronic kidney disease (CKD). This study was aimed to evaluate the effect of implementation of CPGs for early CKD on family physicians (FP) clinical competence and subsequently on kidney function preservation of type 2 diabetes mellitus (DM2) patients at a primary healthcare setting.MethodsA prospective educative intervention (40-h) based on CPGs for Prevention, Diagnosis and Treatment of Early CKD was applied to FP; a questionnaire to evaluate clinical competence was applied at the beginning and end of the educative intervention (0 and 2 months), and 12 months afterwards. DM2 patients with CKD were evaluated during 1-year of follow-up with estimated glomerular filtration rate (eGFR) and albuminuria.ResultsAfter educative intervention, there was a significant increase in FP clinical competence compared to baseline; although it was reduced after 1 year, it remained higher compared to baseline. One-hundred thirteen patients with early nephropathy (58 stage 1, 55 stage 2) and 28 with overt nephropathy (23 stage 3, 5 stage 4) were studied. At final evaluation, both groups maintained eGFR [(mean change) early 0.20 ± 19 pNS; overt 0.51 ± 13 mL/min pNS], whereas albuminuria/creatinuria (early −67 ± 155 p &lt; 0.0001; overt −301 ± 596 mg/g p &lt; 0.0001), systolic blood pressure (early −10 ± 18 p &lt; 0.05; overt −8 ± 20 mmHg p &lt; 0.05), and total cholesterol (early −11 ± 31 p &lt; 0.05; overt −17 ± 38 mg/dL p &lt; 0.05) decreased. Diastolic blood pressure, waist circumference and LDL-cholesterol were also controlled in early nephropathy patients.ConclusionsCPGs for Prevention, Diagnosis and Treatment of CKD, by means of an educative intervention increases FP clinical competence and improves renal function in DM2 patients with CKD.
Glaesserella parasuis autotransporters EspP1 and EspP2 are novel IgA-specific proteases
Authors: Wang Zhichao , Gu Jiayun , Xiao Kunxue , Zhu Wenlong , Lin Yan , Wen Siting , He Qigai , Xu Xiaojuan , Cai Xuwang 
Published: December 2022

BackgroundGlaesserella parasuis causes Glässer’s disease, which is associated with severe polyarthritis, fibrinous polyserositis and meningitis, and leads to significant economic losses to the swine industry worldwide. IgA is one of the most important humoral immune factors present on mucosal surfaces, and it plays a crucial role in neutralizing and removing pathogens. G. parasuis is able to colonize the mucosal membrane of respiratory tract without being eliminated. Nevertheless, the immune evasion mechanism of G. parasuis in thwarting IgA remains unclear.AimsThe object of this study is to characterize the IgA degradation activity of Mac-1-containing autotransporter EspP1 and EspP2 from G. parasuis.MethodsThe swine IgA was purified and incubated with EspP1 and EspP2 respectively. Western blotting was used to detect the cleavage of swine IgA. Generation of EspP1 and EspP2 mutant protein were used to explore the putative active sites of EspPs. LC-MS/MS based N/C-terminal sequencing was performed to measure the cleavage sites in swine IgA.ResultOur results show that G. parasuis EspP1 and EspP2 cleave swine IgA in a dose- and time- dependent manner. G. parasuis lose the IgA protease activity after simultaneously delete espP1 and espP2 indicating that EspP1 and EspP2 are the only two IgA proteases in G. parasuis. The IgA protease activity of EspP1 and EspP2 is affected by the putative active sites which contain Cys47, His172 and Asp194/195. Swine IgA is cleaved within Cα1 and Cα3 domains upon incubation with EspPs. Moreover, EspPs can degrade neither IgG nor IgM while G. parasuis possess the ability to degrade IgM unexpectedly. It suggests that G. parasuis can secrete other proteases to cleave IgM which have never been reported.ConclusionWe report for the first time that both EspP1 and EspP2 are novel IgA-specific proteases and cleave swine IgA within the Cα1 and Cα3 domains. These findings provide a theoretical basis for the EspPs-induced immune evasion.
Quantitative gastrointestinal function and corresponding symptom profiles in autonomic neuropathy
Authors: Langford Jordan S. , Tokita Eric , Martindale Cecilia , Millsap Leah , Hemp James , Pace Laura A. , Cortez Melissa M. 
Published: December 2022

PurposePeripheral neuropathies with autonomic nervous system involvement are a recognized cause of gastrointestinal dysmotility for a wide spectrum of diseases. Recent advances in wireless motility capsule testing allow improved sampling of regional and whole gut motility to aid in the diagnosis of gastrointestinal motility disorders and may provide additional insight into segment-specific enteric involvement of peripheral neuropathies affecting autonomic nervous system function.MethodsWe utilized standardized autonomic nervous system (ANS) reflex assessment and wireless motility capsule testing to evaluate 20 individuals with idiopathic autonomic neuropathy and unexplained gastrointestinal symptoms. Additionally, we examined the relationship between quantifiable autonomic neuropathy and gastrointestinal dysmotility at specific neuroanatomical levels. Symptom profiles were evaluated using the 31-item Composite Autonomic Symptom Score questionnaire (COMPASS-31) and compared to wireless motility capsule data.ResultsWe found that transit times were predominately abnormal (delayed) in the foregut (10 of 20; 50%), while contractility abnormalities were far more prominent in the hindgut (17 of 20; 85%), and that motility and symptom patterns, as assessed by the COMPASS-31 GI domain items, generally corresponded. Finally, we also found that there was neuroanatomical overlap in the presence of autonomic reflex abnormalities and WMC-based transit and/or contractility abnormalities.ConclusionsWe found that transit times were predominately abnormal in the foregut and midgut, while contractility abnormalities were far more prominent in the hindgut in individuals with idiopathic autonomic neuropathy. There was a high rate of agreement in segmental wireless motility capsule data with neuroanatomically corresponding standardized ANS function measures (e.g., cardiovagal, sudomotor, adrenergic). Expanded sudomotor testing, including additional neuroanatomical segments, could provide additional indirect assessment of visceral involvement in ANS dysfunction.
Outcomes associated with antithrombotic strategies in heart failure with reduced ejection fraction and sinus rhythm following acute ischemic stroke
Authors: Patel Parth , Tiongson Justin , Chen Austin , Siegal Taylor , Oak Solomon , Golla Akhil , Kamen Scott , Thon Jesse M. , Vigilante Nicholas , Rana Ameena , Hester Taryn , Siegler James E. 
Published: December 2022

PurposeInsufficient data exist regarding the benefit of long-term antiplatelet vs. anticoagulant therapy in the prevention of recurrent ischemic stroke in patients with ischemic stroke and heart failure with reduced ejection fraction (HFrEF). Therefore, this study aimed to compare longitudinal outcomes associated with antiplatelet vs. anticoagulant use in a cohort of patients with stroke and with an ejection fraction of ≤40%.MethodsWe retrospectively analyzed single-center registry data (2015–2021) of patients with ischemic stroke, HFrEF, and sinus rhythm. Time to the primary outcome of recurrent ischemic stroke, major bleeding, or death was assessed using the adjusted Cox proportional hazards model and was compared between patients treated using anticoagulation (±antiplatelet) vs. antiplatelet therapy alone after propensity score matching using an intention-to-treat (ITT) approach, with adjustment for residual measurable confounders. Sensitivity analyses included the multivariable Cox proportional hazards model using ITT and as-treated approaches without propensity score matching.ResultsOf 2,974 screened patients, 217 were included in the secondary analyses, with 130 patients matched according to the propensity score for receiving anticoagulation treatment for the primary analysis, spanning 143 patient-years of follow-up. After propensity score matching, there was no significant association between anticoagulation and the primary outcome [hazard ratio (HR) 1.10, 95% confidence interval (CI): 0.56–2.17]. Non-White race (HR 2.26, 95% CI: 1.16–4.41) and the presence of intracranial occlusion (HR 2.86, 95% CI: 1.40–5.83) were independently associated with the primary outcome, while hypertension was inversely associated (HR 0.42, 95% CI: 0.21–0.84). There remained no significant association between anticoagulation and the primary outcome in sensitivity analyses.ConclusionIn HFrEF patients with an acute stroke, there was no difference in outcomes of antithrombotic strategies. While this study was limited by non-randomized treatment allocation, the results support future trials of stroke patients with HFrEF which may randomize patients to anticoagulation or antiplatelet.
The influential factors and non-pharmacological interventions of cognitive impairment in children with ischemic stroke
Authors: Xu Gang , Hao Fuchun , Zhao Weiwei , Qiu Jiwen , Zhao Peng , Zhang Qian 
Published: December 2022

BackgroundThe prevalence of pediatric ischemic stroke rose by 35% between 1990 and 2013. Affected patients can experience the gradual onset of cognitive impairment in the form of impaired language, memory, intelligence, attention, and processing speed, which affect 20–50% of these patients. Only few evidence-based treatments are available due to significant heterogeneity in age, pathological characteristics, and the combined epilepsy status of the affected children.MethodsWe searched the literature published by Web of Science, Scopus, and PubMed, which researched non-pharmacological rehabilitation interventions for cognitive impairment following pediatric ischemic stroke. The search period is from the establishment of the database to January 2022.ResultsThe incidence of such impairment is influenced by patient age, pathological characteristics, combined epilepsy status, and environmental factors. Non-pharmacological treatments for cognitive impairment that have been explored to date mainly include exercise training, psychological intervention, neuromodulation strategies, computer-assisted cognitive training, brain-computer interfaces (BCI), virtual reality, music therapy, and acupuncture. In childhood stroke, the only interventions that can be retrieved are psychological intervention and neuromodulation strategies.ConclusionHowever, evidence regarding the efficacy of these interventions is relatively weak. In future studies, the active application of a variety of interventions to improve pediatric cognitive function will be necessary, and neuroimaging and electrophysiological measurement techniques will be of great value in this context. Larger multi-center prospective longitudinal studies are also required to offer more accurate evidence-based guidance for the treatment of patients with pediatric stroke.
Association between oxidative balance score and new-onset hypertension in adults: A community-based prospective cohort study
Authors: Lee Jun-Hyuk , Son Da-Hye , Kwon Yu-Jin 
Published: December 2022

IntroductionOxidative stress plays a key role in the pathophysiology of hypertension development. The oxidative balance score (OBS) comprises dietary and lifestyle pro- and anti-oxidant components and reflects the overall oxidative stress burden. We aimed to evaluate the association between the OBS and new-onset hypertension (HTN) using large, community-based, prospective Korean cohort data.MethodsAmong 10,030 participants aged 40–69 years included in the Korean Genome and Epidemiology Study, the data of 5,181 participants were analyzed. The hazard ratio (HR) and 95% confidence interval (CI) for new-onset HTN according to sex-specific OBS quartile groups were calculated using univariable and multivariable Cox proportional hazard regression analyses.ResultsDuring the mean 13.6-year follow-up period, 1,157 men and 1,196 women developed new-onset HTN. Compared to the Q1 group, the adjusted HRs (95%CI) for new-onset HTN in the Q2, Q3, and Q4 groups were 0.96 (0.82–1.16), 0.85 (0.72–0.99), and 0.71 (0.59–0.86) in men and 0.81 (0.69–0.95), 0.81(0.68–0.95), and 0.70 (0.57–0.84) in women, respectively.DiscussionIndividuals with high OBS are at lower risk of developing HTN. This study suggests that a healthy lifestyle and antioxidant rich diet could be a preventive strategy for HTN.
Preoperative embolization in the treatment of patients with metastatic epidural spinal cord compression: A retrospective analysis
Authors: Zhang Bin , Yu Haikuan , Zhao Xiongwei , Cao Xuyong , Cao Yuncen , Shi Xiaolin , Wang Zheng , Liu Yaosheng 
Published: December 2022

PurposeThe purpose of the study was to assess the effectiveness and safety of preoperative embolization in the treatment of patients with metastatic epidural spinal cord compression (MESCC).MethodsA retrospective analysis of 138 MESCC patients who underwent decompressive surgery and spine stabilization was performed in a large teaching hospital. Among all enrolled patients, 46 patients were treated with preoperative embolization (the embolization group), whereas 92 patients did not (the control group). Patient’s baseline clinical characteristics, surgery-related characteristics, and postoperative neurological status, complications, and survival prognoses were collected and analyzed. Subgroup analysis was performed according to the degree of tumor vascularity between patients with and without preoperative embolization.ResultsPatients with severe hypervascularity experienced more mean blood loss in the control group than in the embolization group, and this difference was statistically significant (P=0.02). The number of transfused packed red cells (PRC) showed a similar trend (P=0.01). However, for patients with mild and moderate hypervascularity, both blood loss and the number of PRC transfusion were comparable across the two groups. Regarding decompressive techniques, the embolization group (64.29%, 9/14) had a higher proportion of circumferential decompression in comparison to the control group (30.00%, 9/30) among patients with severe hypervascularity (P=0.03), whereas the rates were similar among patients with mild (P=0.45) and moderate (P=0.54) hypervascularity. In addition, no subgroup analysis revealed any statistically significant differences in operation time, postoperative functional recovery, postoperative complications, or survival outcome. Multivariate analysis showed that higher tumor vascularity (OR[odds ratio]=3.69, 95% CI [confident interval]: 1.30-10.43, P=0.01) and smaller extent of embolization (OR=4.16, 95% CI: 1.10-15.74, P=0.04) were significantly associated with more blood loss.ConclusionsPreoperative embolization is an effective and safe method in treating MESCC patients with severe hypervascular tumors in terms of intra-operative blood loss and surgical removal of metastatic tumors. Preoperative tumor vascularity and extent of embolization are independent risk factors for blood loss during surgery. This study implies that MESCC patients with severe hypervascular tumors should be advised to undergo preoperative embolization.