bluuebunny/crossref_metadata_2025_split huggingface dataset:
Rationale and design of phase II clinical trial of dual inhibition with ramucirumab and erlotinib in EGFR exon 19 deletion-positive treatment-naïve non-small cell lung cancer with high PD-L1 expression (SPIRAL-3D study)
Authors: Kawachi Hayato , Yamada Tadaaki , Yoshimura Akihiro , Morimoto Kenji , Iwasaku Masahiro , Tokuda Shinsaku , Kim Young Hak , Shimose Takayuki , Takayama Koichi 
Published: June 2023

Background: Osimertinib is a standard treatment option for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). However, osimertinib monotherapy yields poor clinical outcomes in some patients, necessitating the development of novel treatment strategies. In addition, several studies have suggested that high programmed cell death-ligand 1 (PD-L1) expression is associated with poor progression-free survival (PFS) for osimertinib monotherapy in patients with advanced NSCLC harboring EGFR mutations. Objective: To evaluate the clinical efficacy of erlotinib plus ramucirumab for EGFR exon 19 deletion-positive treatment-naïve NSCLC with high PD-L1 expression. Design: A single-arm, prospective, open-label, phase II study Methods and Analysis: Patients with treatment-naïve EGFR exon 19 deletion-positive NSCLC with high PD-L1 expression and a performance status of 0–2 will receive combination therapy with erlotinib plus ramucirumab until evidence of disease progression or development of unacceptable toxicity. High PD-L1 expression is defined as a tumor proportion score of 50% or higher, as determined by PD-L1 immunohistochemistry 22C3 pharmDx testing. The Kaplan–Meier method and the Brookmeyer and Crowley method with the arcsine square-root transformation will be used with PFS as the primary endpoint. The secondary endpoints include overall response rate, disease control rate, overall survival, and safety. A total of 25 patients will be enrolled. Ethics: The study has been approved by the Clinical Research Review Board, Kyoto Prefectural University of Medicine, Kyoto, Japan, and written informed consent will be obtained from all patients. Discussion: To the best of our knowledge, this is the first clinical trial to focus on PD-L1 expression in EGFR mutation-positive NSCLC. If the primary end point is met, combination therapy with erlotinib and ramucirumab could become a potential treatment option for this clinical population. Trial Registration: This trial was registered with the Japan Registry for Clinical Trials on 12 January 2023 (jRCTs 051220149).
Slow-motion smartphone video improves interobserver reliability of gait assessment in ambulatory cerebral palsy
Authors: Brodke Dane J , Makaroff Katherine , Kelly Enda G , Silva Mauricio , Thompson Rachel M 
Published: June 2023

Purpose: Structured visual gait assessment is essential for the evaluation of pediatric patients with neuromuscular conditions. The purpose of this study was to evaluate the benefit of slow-motion video recorded on a standard smartphone to augment visual gait assessment. Methods: Coronal and sagittal plane videos of the gait of five pediatric subjects were recorded on a smartphone, including four subjects with ambulatory cerebral palsy and one subject without gait pathology. Twenty-one video scorers were recruited and randomized to evaluate slow-motion or normal-speed videos utilizing the Edinburgh Visual Gait Score. The slow-motion group (N = 11) evaluated the videos at one-eighth speed, and the normal-speed group (N = 10) evaluated the same videos at normal speed. Interrater reliabilities were determined by calculating intraclass correlation coefficients for each group as a whole, for each Edinburgh Visual Gait Score item, and after stratification by evaluator experience level. Results: The slow-motion group exhibited an intraclass correlation coefficient of 0.65 (95% confidence interval: 0.58–0.73), whereas the normal-speed group exhibited an intraclass correlation coefficient of 0.57 (95% confidence interval: 0.49–0.65). For less-experienced scorers, intraclass correlation coefficients of 0.62 (95% confidence interval: 0.53–0.71) and 0.50 (95% confidence interval: 0.40–0.59) were calculated for slow motion and normal speed, respectively. For more-experienced scorers, intraclass correlation coefficients of 0.69 (95% confidence interval: 0.61–0.76) and 0.67 (95% confidence interval: 0.58–0.75) were calculated for slow motion and normal speed, respectively. Conclusions: Visual gait assessment is enhanced by the use of slow-motion smartphone video, a tool widely available throughout the world with no marginal cost. Level of evidence: level I, randomized study.
Preoperative Opioid Therapy Correlated With Increased Rate of Complications in Foot and Ankle Surgery
Authors: Shrake Kevin , Newton William , Hoch Caroline , Galasso Annemarie , Scott Daniel J. , Gross Christopher E. 
Published: June 2023

Background The purpose of this study is to determine whether patients with a history of preoperative opioid use will have an increased likelihood of postoperative opioid use and complications after undergoing forefoot, hindfoot, or ankle surgery. Methods A retrospective review was conducted on forefoot, hindfoot, and ankle surgeries between 2015 and 2020 with a single fellowship-trained orthopaedic foot and ankle surgeon at an academic medical center. A total of 326 patients (356 feet) were included with a mean follow-up up of 2.12 (range, 1.00-4.98) years. Data collected included demographics, medical comorbidities, treatment history, complications and reoperation rates, patient-reported outcome measures (eg, Foot and Ankle Outcome Score), and opioid exposure. Results There were significantly more complications among opioid exposed patients than opioid naïve ones (exposed = 29.41%, naïve = 9.62%; P = .044). Preoperative opioid exposure significantly correlated with postoperative opioid exposure (90-day: r = .903, p < .001; 180-day: r = .805, p < .001), and increased hospital length of stay (r = .263, p = .029). Furthermore, body mass index was a significant predictor of postoperative opioid exposure (90-day: r = .262, p = .013; 180-day: r = .217, p = .021), as was concomitant mental illness (90-day: r = .225, p = .035). Conclusion Patients with preoperative opioid exposure have significantly more complications and increased postoperative opioid exposure after foot and ankle surgery. Levels of Evidence: Level III: Retrospective cohort study
Intravascular Lymphoma as a Cause of Recurrent Strokes – Case Report and Review of the Literature
Authors: Zhao Charlie Weige , Fan Tracey H. , Denize Thomas , Coraini Alba , Kraft Andrew , Kumar Anusha M. , Gao Lucy G. , Lorenzo Mayra E. , Duncan Lyn M. , Camargo Faye Erica C. , Lin David J. 
Published: June 2023

Background Intravascular lymphoma is an uncommon cause of ischemic strokes. Because of its rarity and atypical pattern, most diagnoses are made post-mortem. Case study We present a case of a 68-year-old male with multiple cardiovascular risk factors and recent SARS-CoV-2 infection who presented with recurrent strokes. Because of his stroke risk factors, he was initially managed with a sequentially escalating antithrombotic regimen. A malignant process was low on the differential at this point given his lack of systemic symptoms. When he continued to have new strokes despite these measures, including a spinal cord infarct, a broad workup was sent including for hypercoagulable states, vasculitis, and intravascular lymphoma. Eventually, a skin biopsy of a cherry angioma returned positive for lymphoma cells. He was treated with methotrexate followed by chemotherapy and rituximab. Unfortunately, he did not improve and was made comfort measures only by his family. Conclusion This case illustrates the importance of considering intravascular lymphoma as a potential etiology of recurrent strokes, as early diagnosis and treatment are important for preventing irreversible neurological damage.
Assessing adverse drug reaction reports for antidiabetic medications approved by the food and drug administration between 2012 and 2017: a pharmacovigilance study
Authors: Stottlemyer Britney A. , McDermott Michael C. , Minogue Mackenzie R. , Gray Matthew P. , Boyce Richard D. , Kane-Gill Sandra L. 
Published: June 2023

Objective: Between 2012 and 2017, the U.S. Food and Drug Administration (FDA) approved 10 antidiabetic indicated therapies. Due to the limited literature on voluntarily reported safety outcomes for recently approved antidiabetic drugs, this study investigated adverse drug reactions (ADRs) reported in the FDA Adverse Event Reporting System (FAERS). Research Design and Methods: A disproportionality analysis of spontaneously reported ADRs was conducted. FAERS reports from January 1, 2012 to March 31, 2022 were compiled, allowing a 5-year buffer following drug approval in 2017. Reporting odds ratios were calculated for the top 10 ADRs, comparing new diabetic agents to the other approved drugs in their therapeutic class. Results: 127,525 reports were identified for newly approved antidiabetic medications listed as the primary suspect (PS). For sodium-glucose co-transporter-2 (SGLT-2) inhibitors, the odds of blood glucose increased, nausea, and dizziness being reported was greater for empagliflozin. Dapagliflozin was associated with greater reports of weight decreased. Canagliflozin was found to have a disproportionally higher number of reports for diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis. Assessing glucagon-like peptide-1 (GLP-1) receptor agonists, dulaglutide and semaglutide were associated with greater reports of gastrointestinal adverse drug reactions. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports. Conclusion: Pharmacovigilance studies utilizing a large publicly available dataset allow an essential opportunity to evaluate the safety profile of antidiabetic drugs utilized in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved antidiabetic medications to determine causality.
The Impact of Combined Warm and Cold Ischemia Time on Post-transplant Outcomes
Authors: Foley Martha E. , Vinson Amanda J. , Skinner Thomas A. A. , Kiberd Bryce A. , Tennankore Karthik K. 
Published: June 2023

Background: Prolonged warm ischemia time (WIT) and cold ischemia time (CIT) are independently associated with post-transplant graft failure; their combined impact has not been previously studied. We explored the effect of combined WIT/CIT on all-cause graft failure following kidney transplantation. Methods: The Scientific Registry of Transplant Recipients was used to identify kidney transplant recipients from January 2000 to March 2015 (after which WIT was no longer separately reported), and patients were followed until September 2017. A combined WIT/CIT variable (excluding extreme values) was separately derived for live and deceased donor recipients using cubic splines; for live donor recipients, the reference group was WIT 10 to <23 minutes and CIT >0 to <0.42 hours, and for deceased donor recipients the WIT was 10 to <25 minutes and CIT 1 to <7.75 hours. The adjusted association between combined WIT/CIT and all-cause graft failure (including death) was analyzed using Cox regression. Secondary outcomes included delayed graft function (DGF). Results: A total of 137 125 recipients were included. For live donor recipients, patients with prolonged WIT/CIT (60 to ≤120 minutes/3.04 to ≤24 hours) had the highest adjusted hazard ratio (HR) for graft failure (HR = 1.61, 95% confidence interval [CI] = 1.14-2.29 relative to the reference group). For deceased donor recipients, a WIT/CIT of 63 to ≤120 minutes/28 to ≤48 hours was associated with an adjusted HR of 1.35 (95% CI = 1.16-1.58). Prolonged WIT/CIT was also associated with DGF for both groups although the impact was more driven by CIT. Conclusions: Combined WIT/CIT is associated with graft loss following transplantation. Acknowledging that these are separate variables with different determinants, we emphasize the importance of capturing WIT and CIT independently. Furthermore, efforts to reduce WIT and CIT should be prioritized.
Social media use, uncertainty, and negative affect in times of pandemic crisis
Authors: Wu Yun , An Zihao , Lin Yi , Zhang Jingyue , Jing Bo , Peng Kaiping 
Published: June 2023

Objective A common assertion in the social media literature is that passive media use undermines affective wellbeing, and active media use enhances it. The present study investigated the effects of social media use on negative affective wellbeing during pandemic crises and examined the mechanism underlying these effects through perceived uncertainty. Methods Three studies were conducted during the Delta variant phase in the post-peak period of the COVID-19 pandemic in China. Participants were recruited from the medium-high-risk infection areas in late August 2021. Study 1 used a cross-sectional survey to explore the relationships between social media use, uncertainty, and negative affect during the pandemic crisis. Study 2 employed a repeated-measures experiment to demonstrate how social media use and (un)certainty impact negative affect. Study 3 utilized a one-week experience sampling design to examine the role of uncertainty in the relationship between social media use and negative affect in real life. Results Despite some inconsistencies regarding social media use's direct effect on negative affect, across the three studies, perceived uncertainty was critical in linking pandemic-related social media use to individuals’ negative affect, particularly for passive use. Conclusions The relationships between social media use and affective wellbeing are complex and dynamic. While the perception of uncertainty provided an underlying mechanism that links social media use to individuals’ affective wellbeing, this mechanism may be further moderated by individual-level factors. More research is needed as we seek to understand how social media use impacts affective wellbeing in uncertain contexts.
Assessment of eHealth literacy to reduce financial toxicity and improve shared decision-making in cancer patients: A cross-sectional study
Authors: Xu Richard Huan , Wang Ling-ling , Zhou Ling-ming , Wong Eliza Lai-yi , Wang Dong 
Published: June 2023

Objectives This study aimed to investigate the associations between eHealth literacy, preferences for financial decision-making, and financial toxicity (FT) in a sample of Chinese cancer patients. Methods Eligible cancer patients were invited to participate in a cross-sectional survey from January to April 2021. Three measures (eHealth literacy scale, control preference scale, and COST) were used to analyze patients’ eHealth literacy, decisional preferences, and FT, respectively. Wilcoxon signed-rank test and Kruskal–Wallis H test assessed the differences between population subgroups. Binary logistic and multivariate linear regression models were used to assess the relationships between eHealth literacy, decisional preferences, and FT. Results A total of 590 cancer patients completed the questionnaire. We found that high FT was associated with poor ECOG performance, severe cancer stage, and longer cancer duration. Patients who preferred to adopt collaborative attitude toward decision-making showed a significantly higher eHealth literacy. However, there was an inverse relationship between eHealth literacy and a patient-driven attitude toward decision-making in female cancer patients. Regression analysis indicated that patients who were highly educated and actively employed might report a higher eHealth literacy. A significant relationship was found between high eHealth literacy and low FT. However, this relationship became insignificant when the background characteristics of cancer patients were taken into account. Conclusions A relationship between enhanced eHealth literacy, preference for collaborative decision-making, and low risk of FT is identified. Practical implication Interventions to improve patients’ ability to use quality and reliable web-based information on cancer care should be encouraged.
Nursing Student and Faculty Narratives During COVID-19 Pandemic: Challenges and Recommendations From a Canadian Perspective
Authors: Orazietti Brenda , Peniston Sandra , Mohammed Zubaida , Demelie Hermila , Duldulao Jemina Frances , Rao Misbah 
Published: June 2023

Introduction Worldwide, COVID-19 affected nursing students’ and faculty's mental and physical health. The final clinical placement for fourth-year nursing students during the third wave of COVID-19 in Toronto, Canada, included direct patient care without vaccination eligibility. Students’ experiences during the pandemic and faculty exposure to teaching and supporting them provide unique reflective opportunities. Objective To examine the lived experiences of nursing students and faculty during the third wave of the COVID-19 pandemic. Methods The study used a qualitative phenomenological design with thematic analysis. A voluntary response sample of 80 participants shared their narratives of working and teaching during January to May 2021. An optional interview guide offered open-ended questions requiring reflection. The study was conducted in a nursing school in Toronto, Canada during fourth-year baccalaureate students final clinical placement settings. Results A total of 77 fourth-year baccalaureate nursing students and three faculty members participated. Thematic analysis of nursing student narratives identified four main themes: (i) fear and anxiety of COVID-19 during clinical practice; (ii) impact on students’ learning environments; (iii) intrinsic and extrinsic factors that enabled students to persevere; and (iv) how to deal with future pandemics. Thematic analysis of faculty narratives identified three main themes: (i) the importance of preparatory work; (ii) psychological and physical manifestations of supporting students; and (iii) the resilience of students and faculty. Conclusion Future disease outbreaks and other large-scale health events will require nurse educators to understand and plan strategies for both themselves and students practicing in high-risk clinical settings. Nursing schools should rethink all fourth-year students’ experiences, perceptions, and feelings to minimize their susceptibility to physical and psychological distress.
Magnitude, Indications, and Factors Associated With Operative Vaginal Delivery Among Mothers Who Gave Birth at Adama Hospital Medical College, Ethiopia, 2022
Authors: Tadesse Workinesh Ketema , Bekele Nardos Tilahun , Negussie Yohannes Mekuria , Getahun Mihiret Shawel , Gurara Abenet Menene , Beyen Teresa Kisi 
Published: June 2023

Introduction Operative vaginal deliveries are a method of dealing with issues that arise during the second stage of labor with the use of vacuum device or forceps. The decision to use an instrument to deliver the fetus weighs the maternal, fetal, and neonatal consequences of the procedure against the alternative option of cesarean birth. However, evidence on operative vaginal delivery is limited in Ethiopia in general and in the study area in particular. Objectives This study aimed to assess the magnitude, indications, and factors associated with operative vaginal delivery among mothers who gave birth at Adama Hospital Medical College, Ethiopia. Methods A facility-based cross-sectional study was conducted among a sample of 440 mothers who gave birth from 1 to 30 June 2022. A systematic random sampling technique was used to select the study participants. Data were collected using an interviewer-administered structured questionnaire. The data were entered into EPI INFO version 7 and exported to SPSS version 25 for analysis. Bivariate logistic regression analysis was used to identify candidate variables at p < .25 and multivariable logistic regression analysis was used to identify the independent predictors of operative vaginal delivery at p < .05 with 95% confidence intervals (CIs). Results The magnitude of operative vaginal delivery was 14.8% (95% CI: 10.8, 18.8). Rural residence (adjusted odds ratio (AOR), 2.09; 95% CI: 2.01, 7.41), maternal age 25–34 (AOR, 4.95; 95% CI: 1.62, 9.2), being primigravida (AOR: 3.5, 95% CI: 1.26, 9.98), gestational age ≥42 weeks (3.09; 95% CI: 1.38, 6.9), and antenatal care (ANC) follow-ups <4 times (AOR:3.9; 95% CI: 1.09, 9.45) were significantly associated with operative vaginal delivery. Conclusion The magnitude of operative vaginal delivery in the study area was relatively low. Rural residence, maternal age 25 to 34, primigravida, gestational age ≥42 weeks, and ANC follow-ups <4 times were independent determinants of operative vaginal delivery. Thus, health education programs and other multidisciplinary strategies are required to encourage mothers to have regular ANC follow-ups.
Clinical Outcomes Following Percutaneous Ankle Fusion With Bone Graft Substitute
Authors: Marciano Gerard F. , Ferlauto Harrison R. , Confino Jamie , Kelly Meghan , Surace Michele F. , Vulcano Ettore 
Published: June 2023

Background: Percutaneous ankle fusion is an emerging technique with minimal published outcome data. The goal of the present study is to retrospectively review clinical and radiographic outcomes following percutaneous ankle fusion and provide technique tips to perform percutaneous ankle fusion. Methods: Patients >18 years of age, treated by a single surgeon, from February 2018 to June 2021, who underwent primary isolated percutaneous ankle fusion supplemented with platelet-derived growth factor B (rhPDGF-BB) and beta-tricalcium phosphate, with at least 1-year follow-up were included. Surgical technique consisted of percutaneous ankle preparation followed by fixation with 3 headless compression screws. Pre- and postoperative visual analog scale (VAS) and Foot Function Index (FFI) were compared using paired t tests. Fusion was assessed radiographically by the surgeon on postoperative radiographs and computed tomography (CT) at 3 months postoperatively. Results: Twenty-seven consecutive adult patients were included in the study. Mean follow-up was 21 months. Mean age was 59.8 years. Mean preoperative and postoperative VAS scores were 7.4 and 0.2, respectively ( P < .01). Mean preoperative FFI pain domain, disability domain, activity restriction domain, and total score were 20.9, 16.7, 18.5, and 56.4, respectively. Mean postoperative FFI pain domain, disability domain, activity restriction domain, and total score were 4.3, 4.7, 6.7, and 15.8, respectively ( P < .01). Fusion was achieved in 26 of 27 patients (96.3%) at 3 months. Four patients (14.8%) had complications. Conclusion: We found in this cohort with surgery performed by a surgeon highly experienced in minimally invasive surgery that percutaneous ankle fusion augmented with a bone graft supplement achieved a high rate of fusion (96.3%) and a significant improvement in pain and function postoperatively while associated with minimal complications. Level of Evidence: Level IV, case series.