bluuebunny/crossref_metadata_2025_split huggingface dataset:
Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials: NeoSTEEP
Authors: Litton Jennifer K. , Regan Meredith M. , Pusztai Lajos , Rugo Hope S. , Tolaney Sara M. , Garrett-Mayer Elizabeth , Amiri-Kordestani Laleh , Basho Reva K. , Best Ana F. , Boileau Jean-Francois , Denkert Carsten , Foster Jared C. , Harbeck Nadia , Jacene Heather A. , King Tari A. , Mason Ginny , O'Sullivan Ciara C. , Prowell Tatiana M. , Richardson Andrea L. , Sepulveda Karla A. , Smith Mary Lou , Tjoe Judy A. , Turashvili Gulisa , Woodward Wendy A. , Butler Lynn Pearson , Schwartz Elena I. , Korde Larissa A. 
Published: July 2023

PURPOSE The Standardized Definitions for Efficacy End Points (STEEP) criteria, established in 2007 and updated in 2021 (STEEP 2.0), provide standardized definitions of adjuvant breast cancer (BC) end points. STEEP 2.0 identified a need to separately address end points for neoadjuvant clinical trials. The multidisciplinary NeoSTEEP working group of experts was convened to critically evaluate and align neoadjuvant BC trial end points. METHODS The NeoSTEEP working group concentrated on neoadjuvant systemic therapy end points in clinical trials with efficacy outcomes—both pathologic and time-to-event survival end points—particularly for registrational intent. Special considerations for subtypes and therapeutic approaches, imaging, nodal staging at surgery, bilateral and multifocal diseases, correlative tissue collection, and US Food and Drug Administration regulatory considerations were contemplated. RESULTS The working group recommends a preferred definition of pathologic complete response (pCR) as the absence of residual invasive cancer in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0 per AJCC staging). Residual cancer burden should be a secondary end point to facilitate future assessment of its utility. Alternative end points are needed for hormone receptor–positive disease. Time-to-event survival end point definitions should pay particular attention to the measurement starting point. Trials should include end points originating at random assignment (event-free survival and overall survival) to capture presurgery progression and deaths as events. Secondary end points adapted from STEEP 2.0, which are defined from starting at curative-intent surgery, may also be appropriate. Specification and standardization of biopsy protocols, imaging, and pathologic nodal evaluation are also crucial. CONCLUSION End points in addition to pCR should be selected on the basis of clinical and biologic aspects of the tumor and the therapeutic agent investigated. Consistent prespecified definitions and interventions are paramount for clinically meaningful trial results and cross-trial comparison.
A Case Series of Stereotactic Radiosurgery First for Trigeminal Neuralgia: A History of Stereotactic Radiosurgery Does Not Complicate Microvascular Decompression
Authors: Nair Sumil K. , Xie Michael E. , Ran Kathleen , Kalluri Anita , Kilgore Collin , Halbert-Elliott Kyra , Huang Judy , Lim Michael , Bettegowda Chetan , Xu Risheng 
Published: July 2023

BACKGROUND AND OBJECTIVES:
The influence of prior stereotactic radiosurgery (SRS) on outcomes of subsequent microvascular decompression (MVD) for patients with trigeminal neuralgia (TN) is not well understood. To directly compare pain outcomes in patients undergoing primary MVD vs those undergoing MVD with a history of 1 prior SRS procedure.

METHODS:
We retrospectively reviewed all patients undergoing MVD at our institution from 2007 to 2020. Patients were included if they underwent primary MVD or had a history of SRS alone before MVD. Barrow Neurological Institute (BNI) pain scores were assigned at preoperative and immediate postoperative time points and at every follow-up appointment. Evidence of pain recurrence was recorded and compared via Kaplan-Meier analysis. Multivariate Cox proportional hazards regression was used to identify factors associated with worse pain outcomes.

RESULTS:
Of patients reviewed, 833 met our inclusion criteria. Thirty-seven patients were in the SRS alone before MVD group, and 796 patients were in the primary MVD group. Both groups demonstrated similar preoperative and immediate postoperative BNI pain scores. There were no significant differences between average BNI at final follow-up between the groups. Multiple sclerosis (hazard ratio (HR) = 1.95), age (HR = 0.99), and female sex (HR = 1.43) independently predicted increased likelihood of pain recurrence on Cox proportional hazards analysis. SRS alone before MVD did not predict increased likelihood of pain recurrence. Furthermore, Kaplan-Meier survival analysis demonstrated no relationship between a history of SRS alone and pain recurrence after MVD (P = .58).

CONCLUSION:
SRS is an effective intervention for TN that may not worsen outcomes for subsequent MVD in patients with TN.
Posterior Reduction and Intra-Articular Cage Fusion With a C2 Nerve Root Preservation Technique for Treating Posterior Atlantoaxial Dislocation Secondary to Os Odontoideum
Authors: Guo Qunfeng , Chen Fei , Zhang Mei , Wang Haibin , Guo Xiang , Lu Xuhua , Ni Bin 
Published: July 2023

BACKGROUND AND OBJECTIVES:
Posterior C1-C2 interlaminae compression fusion with iliac bone graft may lead to donor site complications and recurrent C1 posterior dislocation for posterior atlantoaxial dislocation (AAD) secondary to os odontoideum. C1-C2 intra-articular fusion often needs C2 nerve ganglion transection to facilitate exposing and manipulating the facet joint, leading to bleeding from the venous plexus and suboccipital numbness or pain. Therefore, this study was conducted to evaluate the outcomes of posterior C1-C2 intra-articular fusion with a C2 nerve root preservation technique in the treatment of posterior AAD secondary to os odontoideum.

METHODS:
Data of the 11 patients who underwent C1-C2 posterior intra-articular fusion because of posterior AAD secondary to os odontoideum were retrospectively reviewed. Posterior reduction was performed using C1 transarch lateral mass screws and C2 pedicle screws. Intra-articular fusion was performed using a polyetheretherketone cage filled with autologous bone from the caudal edge of the C1 posterior arch and cranial edge of the C2 laminar. Outcomes were evaluated by using the Japanese Orthopaedics Association score, Neck Disability Index, and visual analog scale for neck pain. Bone fusion was evaluated by using computed tomography and 3-dimensional reconstruction.

RESULTS:
The average follow-up duration was 43.9 ± 9.5 months. All patients achieved good reduction and bone fusion, without transection of the C2 nerve roots. The mean bone fusion time was 4.3 ± 1.1 months. There was no complication related to the surgical approach and instrumentation. Function of the spinal cord manifested by the Japanese Orthopaedics Association score significantly improved (P < .05). The Neck Disability Index score and visual analog scale for neck pain markedly decreased (all P < .05).

CONCLUSION:
Posterior reduction and intra-articular cage fusion with a C2 nerve root preservation technique was a promising treatment of posterior AAD secondary to os odontoideum.
Preparation of Highly Conductive Phthalocyaninato-Cobalt Iodide at the Interface between Aqueous KI Solution and Organic Solvent and Catalytic Properties for Electrochemical Reduction of CO2
Authors: Takase Satoko , Aritsu Taku , Sakamoto Yoichiro , Sakuno Yoshihiro , Shimizu Youichi 
Published: July 2023

Abstract
For the industrial practical use of cobalt phthalocyanine (CoPc) as a catalyst for CO2 reduction, the effect of improving conductivity of CoPc crystal on the catalytic activity was investigated. Focusing on (phthalocyaninato) cobalt iodide (CoPcI), which is a highly conductive charge-transfer complex, a simple method for synthesizing CoPcI by simply mixing at an interface between aqueous KI solution and CH2Cl2 solution containing CF3COOH and CoPc was developed by applying the CoPc crystal phase transformation method. The X-ray diffraction pattern of the obtained powder at the interface of CoPc organic and potassium iodide aqueous solutions revealed that the powder is composed of one-dimensional columns of CoPc and a linear array of triiodide ions (I3−). UV-vis absorption spectra showed that iodide ions (I−) change to triiodide ions (I3−) at the interface between aqueous KI solution and organic solvent under acidic conditions. The catalytic property of CoPcI was investigated by polarization measurement and electrochemical impedance spectroscopy using a gas diffusion carbon electrode. CoPcI showed high catalytic activity for CO2 reduction with high CO production selectivity.
Co-Catalyzed Double [4+2] Cycloaddition Reaction of Tetrakis(methylene)benzobicyclo[2.2.2]octane toward Diaryltriptycenes
Authors: Inoue Ryo , Namba Sora , Morisaki Yasuhiro 
Published: July 2023

Abstract
Tetrakis(methylene)benzobicyclo[2.2.2]octane (TMBO) was used as a novel synthon for triptycene derivatives. Co-catalyzed double [4+2] cycloaddition of arylacetylene and TMBO resulted in diaryl-substituted meso and chiral triptycenes. The obtained chiral molecules exhibited circularly polarized luminescence (CPL), which was elucidated using theoretical calculations.
Long-term effect of non-severe COVID-19 on pulmonary function, functional capacities and physical activities: a cross-section study in Sakaka Aljouf
Authors: Alshammari Maha , SHANB ALSAYED , Alsubaiei Mohammed , youssef Enas 
Published: July 2023

Background: COVID-19 has serious consequences on different body systems particularly the respiratory system with its impact on pulmonary function, functional capacities, physical activities, and personal performance. This study aimed to investigate the long-term effect of COVID-19 on pulmonary function, functional capacities, and physical activities in patients with non-severe COVID-19. Methods: 160 individuals were selected to participate in a cross-section study. Group-I: 80 male and female patients with non-severe COVID-19 at least 3 months after the recovery time. Group-II:80 male and female matched participants. The spirometer, six-minute walk test (6MWT), and International Physical Activity Questionnaire (IPAQ) were used to assess pulmonary function, functional capacities, and physical activities respectively. Shapiro–Wilk’s test was used to test normality of data. The Mann–Whitney and independent t-tests were used to compare the significant differences between both groups. Results: The results show significant differences in pulmonary function, functional capacities, and physical activities, between both COVID-19 and matched groups. Conclusion: Pulmonary function, functional capacities, and physical activities are negatively influenced by COVID-19 as long-term consequences indicating the need for extended health care, and prescription of proper rehabilitative training programs for such patients whatever their severity degree of infection or history of hospitalization. Outcome reflections of the current results raise awareness for physical therapists to tailor the proper rehabilitative training programs for such patients.
Clinical characteristics, risk factors and complications of COVID-19 among critically ill older adults - A case control study
Authors: Ahmed Arfath , Raj Moolambally Sheetal , Boloor Archith , Jain Animesh , Kumar S Nandish , Babu S Sharath 
Published: July 2023

Background: The older population is often disproportionately and adversely affected during humanitarian emergencies, as has also been seen during the COVID-19 pandemic. Data regarding COVID-19 in older adults is usually over-generalized and does not delve into details of the clinical characteristics in them. This study was conducted to analyze clinical and laboratory characteristics, risk factors, and complications of COVID-19 between older adults who survived and those who did not. Methods: We conducted a case-control study among older adults(age> 60 years) admitted to the Intensive Care Unit(ICU) during the COVID-19 pandemic. The non-survivors(cases) were matched with age and sex-matched survivors (control) in a ratio of 1: 3. The data regarding socio-demographics, clinical characteristics, complications, treatment, laboratory data, and outcomes were analyzed. Results: The most common signs and symptoms observed were fever (cases vs controls)(68.92 vs. 68.8%), followed by shortness of breath (62.2% Vs. 52.2%), and cough(47.3% Vs. 60.2%). Our analysis found no association between the presence of any of the comorbidities and mortality. At admission, laboratory markers such as LDH(Lactate Dehydrogenase), WBC(White Blood Count), creatinine, CRP(C-Reactive Protein), D-dimer, ferritin, and IL-6 were found to be significantly higher among the cases than among the controls. Complications such as the development of seizure, bacteremia, acute renal injury, respiratory failure, and septic shock were seen to have a significant association with non-survivors. Conclusions: Hypoxia, tachycardia, and tachypnoea at presentation were associated with higher mortality. The older adults in this study mostly presented with the typical clinical features of COVID-19 pneumonia. The presence of comorbid-illnesses among them did not affect mortality. Higher death was seen among those with higher levels of CRP, LDH, D-dimer, and ferritin; and with lower lymphocyte counts.
Five-alpha reductase inhibitors and risk of prostate cancer among men with benign prostatic hyperplasia: A historical cohort study using primary care data
Authors: Thakrar Dixa B , Douglas Ian J , Smeeth Liam , Bhaskaran Krishnan 
Published: July 2023

Background: Five-alpha reductase inhibitors (5ARIs) are used in the management of benign prostatic hyperplasia (BPH). 5ARIs prevent the conversion of testosterone to dihydrotestosterone, which is important in prostate development. It has been suggested that 5ARIs can be used a chemopreventative agent for prostate cancer. The aim of this study was to assess the risk of prostate cancer associated with 5ARI use among men with BPH. Methods: Using Clinical Practice Research Datalink (CPRD) from 1992 to 2011 in UK, prostate cancer risk was retrospectively compared in men with a new diagnosis of BPH, with no history of prostate cancer who were treated with 5ARIs, to men treated with alpha blockers (ABs) and those given no pharmacological treatment. Incidence rate of prostate cancer was calculated by treatment group; the association between BPH treatment group and prostate cancer was estimated by a multivariate Cox model. Results: 77,494 men with newly diagnosed BPH were included. The crude incidence rate of prostate cancer was 892.4 cases per 100,000 person-years amongst those treated with 5ARIs, compared with 1209.0 and 1542.9 in those treated with ABs and untreated individuals, respectively. The HR adjusted for potential confounders was 0.79 (0.72-0.86) for 5ARI vs ABs and 0.72 (0.66-0.79) for 5ARI vs untreated. After excluding the first year after BPH diagnosis, adjusted HRs attenuated to 0.87 (0.79-0.97) for 5ARI vs ABs and 0.97 (0.87-1.08) for 5ARI vs untreated. Conclusion: Among men diagnosed with BPH, we found evidence of lower risks of subsequent prostate cancer in those treated with 5ARIs, but this appeared to be driven by cases diagnosed within a year of BPH, possibly reflecting prevalent prostate cancers that were initially misdiagnosed. After excluding the first year after BPH diagnosis, there was little evidence of a reduced prostate cancer risk in those taking 5ARIs.
Avaliação dinâmica: encontros e desencontros na educação inclusiva
Authors: Santana Ana Paula Oliveira , Figueira Ana Paula Mendes Correia Couceiro 
Published: July 2023

O modelo de avaliação da aprendizagem escolar para alunos da educação especial tem sido pouco discutido. Não há documentos orientadores definidos para esse tema. Diante disso, muitas vezes as avaliações são realizadas de forma estática e classificatória sem, contudo, apontar as potencialidades dos sujeitos. Muito embora a perspectiva sócio-histórica tenha permeado vários documentos governamentais, a avaliação realizada a partir dessa perspectiva não tem sido privilegiada. Nesse sentido, o objetivo desse estudo é discutir a avaliação dinâmica como possibilidade de trabalho para a educação especial na perspectiva da educação inclusiva. Faremos isso a partir de uma revisão crítica de literatura. Este estudo revelou lacunas nas referências bibliográficas sobre esse tema. A avaliação dinâmica deve e pode ser considerada como potencialmente importante para o contexto da educação especial pois ela leva em conta a singularidade e o processo de aprendizagem de cada sujeito, a partir da mediação do professor. Desta forma, acredita-se que a discussão sobre a avaliação dinâmica de perspectiva vygotskyana, vai ao encontro de uma educação inclusiva e para todos.
The potential impact of novel tuberculosis vaccine introduction on economic growth in low- and middle-income countries: A modeling study
Authors: Portnoy Allison , Arcand Jean-Louis , Clark Rebecca A. , Weerasuriya Chathika K. , Mukandavire Christinah , Bakker Roel , Patouillard Edith , Gebreselassie Nebiat , Zignol Matteo , Jit Mark , White Richard G. , Menzies Nicolas A. 
Published: July 2023

BackgroundMost individuals developing tuberculosis (TB) are working age adults living in low- and middle-income countries (LMICs). The resulting disability and death impact economic productivity and burden health systems. New TB vaccine products may reduce this burden. In this study, we estimated the impact of introducing novel TB vaccines on gross domestic product (GDP) growth in 105 LMICs.Methods and findingsWe adapted an existing macroeconomic model to simulate country-level GDP trends between 2020 and 2080, comparing scenarios for introduction of hypothetical infant and adolescent/adult vaccines to a no-new-vaccine counterfactual. We parameterized each scenario using estimates of TB-related mortality, morbidity, and healthcare spending from linked epidemiological and costing models. We assumed vaccines would be introduced between 2028 and 2047 and estimated incremental changes in GDP within each country from introduction to 2080, in 2020 US dollars. We tested the robustness of results to alternative analytic specifications. Both vaccine scenarios produced greater cumulative GDP in the modeled countries over the study period, equivalent to $1.6 (95% uncertainty interval: $0.8, 3.0) trillion for the adolescent/adult vaccine and $0.2 ($0.1, 0.4) trillion for the infant vaccine. These GDP gains were substantially lagged relative to the time of vaccine introduction, particularly for the infant vaccine. GDP gains resulting from vaccine introduction were concentrated in countries with higher current TB incidence and earlier vaccine introduction. Results were sensitive to secular trends in GDP growth but relatively robust to other analytic assumptions. Uncertain projections of GDP could alter these projections and affect the conclusions drawn by this analysis.ConclusionsUnder a range of assumptions, introducing novel TB vaccines would increase economic growth in LMICs.
Assessing a biomarker’s ability to reduce invasive procedures in patients with benign lung nodules: Results from the ORACLE study
Authors: Pritchett Michael A. , Sigal Barry , Bowling Mark R. , Kurman Jonathan S. , Pitcher Trevor , Springmeyer Steven C. ,   for the ORACLE Study Investigators
Published: July 2023

A blood-based integrated classifier (IC) has been clinically validated to improve accuracy in assessing probability of cancer risk (pCA) for pulmonary nodules (PN). This study evaluated the clinical utility of this biomarker for its ability to reduce invasive procedures in patients with pre-test pCA ≤ 50%. This was a propensity score matching (PSM) cohort study comparing patients in the ORACLE prospective, multicenter, observational registry to control patients treated with usual care. This study enrolled patients meeting the intended use criteria for IC testing: pCA ≤ 50%, age ≥40 years, nodule diameter 8–30 mm, and no history of lung cancer and/or active cancer (except for non-melanomatous skin cancer) within 5 years. The primary aim of this study was to evaluate invasive procedure use on benign PNs of registry patients as compared to control patients. A total of 280 IC tested, and 278 control patients met eligibility and analysis criteria and 197 were in each group after PSM (IC and control groups). Patients in the IC group were 74% less likely to undergo an invasive procedure as compared to the control group (absolute difference 14%, p <0.001) indicating that for every 7 patients tested, one unnecessary invasive procedure was avoided. Invasive procedure reduction corresponded to a reduction in risk classification, with 71 patients (36%) in the IC group classified as low risk (pCA < 5%). The proportion of IC group patients with malignant PNs sent to surveillance were not statistically different than the control group, 7.5% vs 3.5% for the IC vs. control groups, respectively (absolute difference 3.91%, p 0.075). The IC for patients with a newly discovered PN has demonstrated valuable clinical utility in a real-world setting. Use of this biomarker can change physicians’ practice and reduce invasive procedures in patients with benign pulmonary nodules.Trial registration: Clinical trial registration: ClinicalTrials.govNCT03766958.
Effects of a low-carbohydrate diet in adults with type 1 diabetes management: A single arm non-randomised clinical trial
Authors: Turton Jessica L. , Brinkworth Grant D. , Parker Helen M. , Lim David , Lee Kevin , Rush Amy , Johnson Rebecca , Rooney Kieron B. 
Published: July 2023

Public interest in low-carbohydrate (LC) diets for type 1 diabetes (T1D) management has increased. This study compared the effects of a healthcare professional delivered LC diet compared to habitual diets higher in carbohydrates on clinical outcomes in adults with T1D. Twenty adults (18–70 yrs) with T1D (≥6 months duration) with suboptimal glycaemic control (HbA1c>7.0% or >53 mmol/mol) participated in a 16-week single arm within-participant, controlled intervention study involving a 4-week control period following their habitual diets (>150 g/day of carbohydrates) and a 12-week intervention period following a LC diet (25–75 g/day of carbohydrates) delivered remotely by a registered dietitian. Glycated haemoglobin (HbA1c –primary outcome), time in range (blood glucose: 3.5–10.0 mmol/L), frequency of hypoglycaemia (<3.5 mmol/L), total daily insulin, and quality of life were assessed before and after the control and intervention periods. Sixteen participants completed the study. During the intervention period, there were reductions in total dietary carbohydrate intake (214 to 63 g/day; P<0.001), HbA1c (7.7 to 7.1% or 61 to 54 mmol/mol; P = 0.003) and total daily insulin use (65 to 49 U/day; P<0.001), increased time spent in range (59 to 74%; P<0.001), and improved quality of life (P = 0.015), with no significant changes observed during the control period. Frequency of hypoglycaemia episodes did not differ across timepoints, and no episodes of ketoacidosis or other adverse events were reported during the intervention period. These preliminary findings suggest that a professionally supported LC diet may lead to improvements in markers of blood glucose control and quality of life with reduced exogenous insulin requirements and no evidence of increased hypoglycaemia or ketoacidosis risk in adults with T1D. Given the potential benefits of this intervention, larger, longer-term randomised controlled trials are warranted to confirm these findings.
Trial Registration: https://www.anzctr.org.au/ACTRN12621000764831.aspx