bluuebunny/crossref_metadata_2025_split huggingface dataset:
Frequency, severity, and impact on daily life of delayed and intercycle chemotherapy-induced nausea, vomiting, and retching
Authors: Gonella Silvia , Di Massimo Dino S. , Mistrangelo Marinella , Numico Gianmauro , Berchialla Paola , Di Giulio Paola 
Published: February 2021

Introduction: Chemotherapy-induced nausea, vomiting, and retching (CINVR) remains a common side effect of treatment. Most previous studies have focused on vomiting control; nausea and retching have been less explored. This study aimed at describing the incidence, severity, and impact on daily life (IDL) of CINVR in the acute (0–24 hours), delayed (>24–120 hours), and overall (0–120 hours) postchemotherapy periods and beyond 120 hours (until next chemotherapy administration); and the pharmacologic and nonpharmacologic strategies adopted by patients to relieve symptoms. Methods: This was a single-center, cross-sectional study of 60 patients undergoing chemotherapy. Participants reported the frequency, severity, and IDL of CINVR from the day of chemotherapy administration up to 120 hours thereafter and nausea and vomiting that occurred beyond 120 hours, as well as pharmacologic and nonpharmacologic remedies used. Results: Forty-seven (78.3%, 95% confidence interval [CI] 66.4–86.9), 37 (61.7%, 95% CI 49.0–72.9), and 35 (58.3%, 95% CI 45.7–69.9) patients reported no nausea (Numeric Rating Scale ⩽1), vomiting, or retching in the acute, delayed, and overall periods, respectively. Nausea was more frequent, more severe, and had a greater IDL than did vomiting and retching across the overall observation period; beyond 120 hours, 11 (18.3%, 95% CI 10.6–29.9) patients reported nausea and none reported vomiting, with a median IDL of 1/10 (interquartile range: 0.75–5.00; 95% CI 0–7.6). Metoclopramide (n = 57 administrations), dexamethasone (n = 28), eating small servings of food (n = 13), and aloe (n = 11) were the most commonly used rescue therapies. Conclusions: Future studies should set hard outcomes, such as the absence of any symptoms, as a primary end point, and these should be assessed across and beyond the 120-hour period.
Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study
Authors: Ashina Messoud , Reuter Uwe , Smith Timothy , Krikke-Workel Judith , Klise Suzanne R , Bragg Sonja , Doty Erin G , Dowsett Sherie A , Lin Qun , Krege John H 
Published: February 2021

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810
Clinical characteristics and outcomes of people living with HIV hospitalized with COVID-19: a nationwide experience
Authors: Ceballos Maria Elena , Ross Patricio , Lasso Martin , Dominguez Isabel , Puente Marcela , Valenzuela Pablo , Enberg Margarita , Serri Michel , Muñoz Rodrigo , Pinos Yazmin , Silva Macarena , Noguera Matías , Dominguez Angelica , Zamora Francisco ,   on behalf of Chilean HIV/COVID-19 Study Group
Published: February 2021

In this prospective, multicentric, observational study, we describe the clinical characteristics and outcomes of people living with HIV (PLHIV) requiring hospitalization due to COVID-19 in Chile and compare them with Chilean general population admitted with SARS-CoV-2. Consecutive PLHIV admitted with COVID-19 in 23 hospitals, between 16 April and 23 June 2020, were included. Data of a temporally matched-hospitalized general population were used to compare demography, comorbidities, COVID-19 symptoms, and major outcomes. In total, 36 PLHIV subjects were enrolled; 92% were male and mean age was 44 years. Most patients (83%) were on antiretroviral therapy; mean CD4 count was 557 cells/mm3. Suppressed HIV viremia was found in 68% and 56% had, at least, one comorbidity. Severe COVID-19 occurred in 44.4%, intensive care was required in 22.2%, and five patients died (13.9%). No differences were seen between recovered and deceased patients in CD4 count, HIV viral load, or time since HIV diagnosis. Hypertension and cardiovascular disease were associated with a higher risk of death ( p = 0.02 and 0.006, respectively). Compared with general population, the HIV cohort had significantly more men (OR 0.15; IC 95% 0.07–0.31) and younger age (OR 8.68; IC 95% 2.66–28.31). In PLHIV, we found more intensive care unit admission (OR 2.31; IC 95% 1.05–5.07) but no differences in the need for mechanical ventilation or death. In this cohort of PLHIV hospitalized with COVID-19, hypertension and cardiovascular comorbidities, but not current HIV viro-immunologic status, were the most important risk factors for mortality. No differences were found between PLHIV and general population in the need for mechanical ventilation and death.
Age differences in secular trends in black–white disparities in mortality from systemic lupus erythematosus among women in the United States from 1988 to 2017
Authors: Guo Qianyu , Liang Meie , Duan Jiaoniu , Zhang Liyun , Kawachi Ichiro , Lu Tsung-Hsueh 
Published: February 2021

Objective To examine the age differences in secular trends in black–white disparities in mortality from systemic lupus erythematosus (SLE) among women in the United States from 1988 to 2017. Methods We used mortality data to calculate age-specific SLE and all-causes (as reference) mortality rates and black/white mortality rates ratios among women from 1988 to 2017. Annual percent change was estimated using joinpoint regression analysis. Results We identified 10,793 and 4,165,613 black women and 19,455 and 31,129,528 white women who died between 1988 and 2017 from SLE and all-causes, respectively. The black/white SLE mortality rate ratio according joinpoint regression model was 6.6, 7.2, 4.4, and 1.4 for decedents aged 0–24, 25–44, 45–64, and 65+ years in 1988 and was 7.2, 5.9, 4.1, and 1.9, respectively in 2017. No significant decline trend was noted and the annual percent change was 0.3%, –0.7%, –0.2%, and 1.0%, respectively. On the contrast, the black/white all-causes mortality rate ratio was 2.0, 2.5, 1.8, and 1.0, respectively in 1988 and was 1.7, 1.3, 1.5, and 0.9, respectively in 2017, a significant decline trend was noted in each age group. Conclusions Black adults, youths and adolescents had four to seven times higher SLE mortality rates than their white counterparts and the black–white disparities persisted during the past three decades. On the contrast, black women had less than two times higher all-causes mortality rates than their white counterparts and black–white disparities significantly diminish during the past three decades.
Low Serum Albumin Level Is a Risk Factor for Delayed Methotrexate Elimination in High-Dose Methotrexate Treatment
Authors: Kataoka Tatsuo , Sakurashita Hiroshi , Kajikawa Kazuya , Saeki Yasuyuki , Taogoshi Takanori , Matsuo Hiroaki 
Published: February 2021

Background In high-dose methotrexate (HD-MTX) therapy, delayed elimination of MTX from plasma leads to severe adverse effects. However, the risk factors for the delayed elimination of plasma MTX are still unclear. Objective The purpose of this study was to investigate the factors related to the delayed MTX elimination in HD-MTX monotherapy. Methods This retrospective study was performed on patients who received HD-MTX monotherapy between April 2009 and March 2019 at the Hiroshima University Hospital. Patients were divided into a “Normal” and a “Delayed” group according to their MTX plasma concentration at 48 or 72 hours after administration. Patient characteristics, dose of HD-MTX, MTX plasma concentration, and adverse effects were analyzed and compared between the 2 groups. Results A total of 74 patients were included in this study. Logistic analysis of patient baseline characteristics was performed to identify risk factors for delayed MTX elimination. Serum albumin (ALB) was detected as a risk factor. Univariate and multivariate analysis revealed that low ALB level (<3.7 g/dL) and type of cancer were associated with delayed MTX elimination (univariate analysis: odds ratio [OR] = 6.00, P = 0.004, and OR = 4.33, P = 0.039, respectively; multivariate analysis: adjusted OR [AOR] = 6.45, P = 0.006, and AOR = 8.11, P = 0.018, respectively). Adverse effects were not significantly different between the 2 groups, excluding renal impairment. Conclusions and Relevance Our study showed that low ALB is a risk factor for delayed MTX elimination in HD-MTX monotherapy. Pharmacokinetic analysis is needed to establish the dose of HD-MTX in patients with a low ALB level.
Comparison of serum and plasma SDMA measured with point-of-care and reference laboratory analysers: implications for interpretation of SDMA in cats
Authors: Baral Randolph M , Freeman Kathleen P , Flatland Bente 
Published: February 2021

Objectives Symmetric dimethylarginine (SDMA) reflects the glomerular filtration rate (GFR) in people, dogs and cats. Initial assays used a liquid chromatography-mass spectroscopy (LC-MS) technique. A veterinary immunoassay has been developed for use in commercial laboratories and point-of-care (POC) laboratory equipment. This study sought to: determine POC and commercial laboratory (CL) SDMA assay imprecision; determine any bias of the POC assay compared with the CL assay; calculate observed total error of the POC assay and compare with analytical performance goals; and calculate dispersion and sigma metrics (σ) for POC and CL SDMA methods. Methods Two separate studies were performed that assessed: (1) imprecision, determined by evaluation of pooled feline plasma or serum; and (2) bias, assessed by comparing pooled plasma and serum results, as well as paired analyses of clinical samples from a single venepuncture measured using both analysers. Results were assessed in relation to performance goals. Dispersion and σ were calculated for both analysers. Results Bias between CL and POC analysers was consistent and high numbers of clinical results were outside performance goals across both studies. Imprecision was poor for both analysers for study 1 and improved to within quality goals for the CL analyser for study 2. Dispersion was at least 40%, meaning a measured result of 14 μg/dl represents a range of possible results from 8 μg/dl to 20 μg/dl. Conclusions and relevance Clinicians should be careful ascribing medical significance to small changes in SDMA concentration, as these may reflect analytical and biological variability. Analyser-specific reference intervals are likely required.
Elevated Intestinal Inflammation in Preterm Infants With Signs and Symptoms of Gastroesophageal Reflux Disease
Authors: Shelly Colleen E. , Filatava Evgenia J. , Thai Julie , Pados Britt F. , Rostas Sara E. , Yamamoto Hidemi , Fichorova Raina , Gregory Katherine E. 
Published: February 2021

Objectives: Reflux is common in infancy; however, persistent signs and symptoms of gastrointestinal distress are often attributed to gastroesophageal reflux disease (GERD). In this pilot study, we aimed to characterize associations between signs and symptoms of suspected GERD and noninvasive markers of intestinal inflammation in preterm infants. Methods: We reviewed Electronic Medical Record (EMR) data to identify clinical signs and symptoms among case patients (n = 16). Controls (n = 16) were matched on gestational age. Univariate and multivariate regression analyses were used to compare fecal calprotectin and urinary intestinal fatty acid binding protein (I-FABP) levels between cases and controls. Results: We found no differences in baseline characteristics between cases and controls. In the multivariate regression analysis controlling for the proportion of mother’s milk, cases had higher fecal calprotectin levels than controls, with no differences in I-FABP levels between cases and controls. Conclusion: Our findings suggest that preterm infants with signs and symptoms of GERD have higher levels of intestinal inflammation as indicated by fecal calprotectin compared to their controls. Further studies are needed to evaluate the role of intestinal inflammation in signs and symptoms of gastrointestinal distress and whether fecal calprotectin might have predictive value in diagnosing GERD.
Home care in dementia: The views of informal carers from a co-designed consultation
Authors: Dalgarno Elizabeth L , Gillan Vincent , Roberts Amy , Tottie Jean , Britt David , Toole Cecilia , Clarkson Paul 
Published: February 2021

Background In the United Kingdom, there is a current priority for high-quality dementia care provided at home. However, home care or domiciliary care is an area where problems have been reported, in terms of a lack of consistency, coordination and appropriate responses to the specific needs of those with dementia. The views of informal carers, who often must respond to these problems when supporting relatives, are crucial in shedding light on the issues and in seeking to promote solutions. Methods This study explored the views of informal carers of those with dementia concerning home care, through a consultation using an electronic survey. The survey questions were designed by informal carers, through a public involvement group within an existing programme of dementia research. The survey elicited responses from 52 informal carers in 2017/18. The data were analysed qualitatively using framework analysis. Findings Carers’ views focused on the need for investment into meaningful personalisation, recognising the value of providing care and valuing formal carers, systemic failings of care coordination and provision and the importance of ongoing collaboration and care planning. Conclusion Based on a framework drawn from the views of informal carers themselves, this study articulated issues of concern for home care and its delivery for people with dementia. Attempts should be made to make dementia home care more consistently personalised, inclusive and collaborative with informal carers and key others involved. Further areas to explore include working conditions of formal carers and current models utilised in homecare provision.
Evaluation of Aortic Zone 2 Proximal Landing Accuracy During Thoracic Endovascular Aortic Repair Following Carotid-Subclavian Revascularization
Authors: Choi Sally H. J. , Yang Gary K. , Baxter Keith , Gagnon Joel 
Published: February 2021

Background: Adequate seal for thoracic endovascular aortic repair (TEVAR) commonly requires landing in zone 2, but can prove to be challenging due to the tortuous and angulated anatomy of the region. Objectives: Our objective was to determine the proximal landing accuracy of zone 2-targeted TEVARs following carotid-subclavian revascularization (CSR) and its impact on clinical outcomes. Methods: Retrospective review of patients that underwent CSR for zone 2 endograft delivery at a tertiary institute between January 2008 and March 2018 was conducted. Technical outcomes were assessed by examining the incidence of intraoperative corrective maneuvers, 1a endoleaks and reinterventions. Distance to target and incidence of LSA stump filling were examined as radiographic markers of landing accuracy. Results: Zone 2-targeted TEVAR with CSR was performed in 53 patients for treatment of dissections (49%), aneurysms (30%) or trauma (21%). Nine (17%) cases required intraoperative corrective procedures: 5 (9%) proximal cuffs due to type 1a endoleak and 4 (8%) left common carotid artery (LCCA) stenting due to inadvertent coverage. Cases performed using higher resolution hybrid fluoroscopy machine compared to mobile C-arm were associated with increased proximal cuff use (OR 8.8; 95% CI 1.2-62.4). Average distance between the proximal edge of the covered graft to LCCA was 8 ± 1 mm and larger distances were not associated with higher rates of 1a endoleak. Twenty-eight (53%) cases of antegrade LSA stump filling were noted on follow-up imaging, but were not associated with higher rates of reinterventions (OR 0.8, 95% CI [0.2-4.6]). Three (6%) patients had a stroke within 30 days and 4 (8%) patients expired within 1 month. Intraoperative corrective maneuvers, post-operative 1a endoleak and reinterventions were not associated with higher rates of stroke or mortality. Conclusion: Using current endografts and imaging modalities, zone 2-targeted TEVARs have suboptimal technical accuracy.
CARE: an observational study of adherence to home nebulizer therapy among children with asthma
Authors: Zhao Deyu , Chen Dehui , Li Ling , Zou YingXue , Shang Yunxiao , Zhang Chonglin , Zhang Li , Pan Jiahua , Chen Qiang , Ai Tao , Ni Qian 
Published: February 2021

Background: The prevalence of pediatric asthma in China is approximately 3%, and asthma remains poorly controlled in many of these patients. This study assessed the rate of adherence to home nebulizer treatment in paediatric patients in China. Methods: The CARE study was a 12-week, multicentre, prospective, observational study across 12 tertiary hospitals in China. Patients were aged 0–14 years, clinically diagnosed with asthma and prescribed home nebulizer inhaled corticosteroid (ICS) therapy for ⩾3 months. The primary endpoint was electronically monitored treatment adherence. Patients attended onsite visits at 0, 4, 8 and 12 weeks to assess asthma control, severity and treatment adherence (recorded by electronic monitoring devices and caregivers). Results: The full analysis set included 510 patients. Median treatment adherence reported by electronic monitoring devices was 69.9%, and median caregiver-reported adherence was 77.9%. The proportion of patients with well-controlled asthma increased from 12.0% at baseline to 77.5% at visit 4. Increased time between asthma diagnosis and study enrolment was a significant predictor for better adherence [coefficient: 0.01, p = 0.0138; 95% confidence interval (CI): 0.00, 0.01] and asthma control (odds ratio = 1.001, p = 0.0498; 95% CI: 1.000, 1.002). Negative attitude to treatment by the caregiver was associated with poorer asthma control. Conclusions: Adherence to home nebulization, a widely used treatment for asthma, was high among Chinese pediatric patients. Asthma control improved with increasing treatment duration. These results suggest that home nebulization of ICS is an effective and recommendable long-term treatment for paediatric patients with asthma. Trial registration ClinicalTrials.gov identifier: NCT03156998 The reviews of this paper are available via the supplemental material section.
Diagnosis of tuberculosis pleurisy with three endoscopic features via pleuroscopy
Authors: Lee Chung-Shu , Li Shih-Hong , Chang Chih-Hao , Chung Fu-Tsai , Chiu Li-Chung , Chou Chu-Liang , Wang Chih-Wei , Lin Shu-Min 
Published: February 2021

Background: Tuberculosis (TB) is a constant threat even with a worldwide active public health campaign. Diagnosis of TB pleurisy is challenging in the case of pleural effusion of unknown origin after aspiration analysis. The study was designed to demonstrate a simple image interpretation technique to differentiate TB pleurisy from non-TB pleurisy using semi-rigid pleuroscopy. Methods: The study retrospectively enrolled 117 patients who underwent semi-rigid pleuroscopy from April 2016 to August 2018 in a tertiary hospital. We analyzed the possibility of TB pleurisy using three simple pleuroscopic images via semi-rigid pleuroscopy. Results: Among 117 patients, 28 patients (23.9%) were diagnosed with TB pleurisy. Sago-like nodules/micronodules, adhesion, and discrete distribution were noted in 20 (71.4%), 20 (71.4%), and 19 (67.9%) patients with TB pleurisy, respectively. Sago-like nodules/micronodules, adhesion, and discrete distribution were noted in six (6.7%), 37 (41.6%), and no (0.0%) patients with non-TB pleurisy, respectively. The positive and negative predictive values of any two out of three pleuroscopic patterns for TB pleurisy were 100.0% and 93.7%, respectively. Conclusions: A high positive predictive value for TB pleurisy was demonstrated by the presence of any two out of the three characteristic features. Absence of all three features had an excellent negative predictive value for TB pleurisy. Our diagnostic criteria reconfirm that pleuroscopic images can be used as predictors for TB pleurisy in patients with undiagnosed pleural effusion. The reviews of this paper are available via the supplementary material section.
Inflammatory Profile of Antrochoanal Polyps in the Caucasian Population – A Histologic Study
Authors: Warman Meir , Kamar Matias Alma , Yosepovich Ady , Halperin Doron , Cohen Oded 
Published: February 2021

Background Antrochoanal polyp (ACP) is a rare and unique unilateral nasal polyp. In contrast to diffuse primary chronic rhinosinusitis (d-CRS) the inflammatory profile of ACP in the Caucasian population have not been determined. Objective The purpose of the study is to describe and differentiate the inflammatory features of ACP compared with d-CRS and its phenotypic subgroups and hypertrophic turbinates (HT) in the Caucasian population, and compare the mast and plasma cell marker expression of each pathology. Methods A retrospective case control study of 96 patients operated on between the years 2005–2017. Nasal biopsies of ACPs, d-CRS and HTs were compared. A comparison of the different phenotypic subgroups of d-CRS was made as well. Demographics, comorbidities, and histologic and immunohistochemical (IHC) staining of mast (CD117) and plasma cell (CD138) receptor antibodies, were compared and analyzed. Results A total of 96 patients were included, consisting of 40 (41.6%) ACP, 36 (37.5%) d-CRS and 20 (20.8%) HT patients. ACPs displayed a significantly higher level of edema and intramural cysts compared to the other groups. Squamous metaplasia was demonstrated in ACP (27.5%) and d-CRS (25.6%), but not in HT. The ACP group was characterized by neutrophilic predominant infiltrates as opposed to the eosinophilic predominance in the d-CRS group, especially in eosinophilic CRS and central compartment allergic disease. ACP presented lower levels of both mast and plasma cells compared to d-CRS and HT in IHC staining. Conclusions ACP in the Caucasian population has unique features of cyst formation and edema which is compatible with its clinical presentation. It is characterized by neutrophilic predominant infiltrates and expresses lower levels of mast and plasma cells as demonstrated by IHC.