bluuebunny/crossref_metadata_2025_split huggingface dataset:
ALTER-C-001: Efficacy and safety of anlotinib plus XELOX regimen as first-line treatment followed by maintenance monotherapy of anlotinib for patients with mCRC—A single-arm, multicenter, phase Ⅱ clinical trial.
Authors: Yan Jin , Zhang Li , Jin Yongdong , Han Yunwei , Sun Hao 
Published: January 2021

70 Background: The combination of anti-VEGF or anti-EGFR targeted drugs with chemotherapy is considered as the standard first-line therapy for metastatic colorectal cancer (mCRC), and maintenance treatment is proven to be a promising and controversial therapeutic strategy which is mainly involved bevacizumab or capecitabine. However, studies regarding the maintenance strategies based on antiangiogenic TKIs are limited currently. Anlotinib is a novel oral multi-target TKI which can inhibit both tumor angiogenesis and tumor cell proliferation simultaneously. Previous studies indicated that anlotinib demonstrated clinical benefits for patients with mCRC. This study aimed to evaluate the efficacy and safety of anlotinib plus XELOX as first-line treatment followed by anlotinib maintenance therapy for mCRC. Methods: ALTER-C-001 trial was an open label, single-arm, multicenter phase II study. A calculated sample size of 53 patients with previously untreated mCRC, ranging from 18-75 years old and an ECOG performance status ≤ 1 were planned to recruit. Eligible patients were treated with capecitabine (1000 mg/m2, po, d1-14, q3w) and oxaliplatin (130 mg/m2, iv, d1, q3w) plus anlotinib (10mg, po, d1~14, q3w) for 6 cycles followed by maintenance therapy of anlotinib (12mg, po, d1~14, q3w) until disease progression or intolerable adverse events (AEs). The primary endpoint was progression-free survival (PFS). Secondary endpoints were ORR, DCR, DOR and safety. Results: From January 2020 to September 2020, a total of 9 patients were enrolled, 6 patients were available for efficacy assessment. In best overall response assessment (all confirmed), there were 66.7% PR (4/6), 16.7% SD (1/6) and 16.7% PD (1/6). The preliminary ORR and DCR of the 6 patients was 66.7% (95% CI, 22.3-95.7%) and 83.3% (95% CI, 35.9-99.6%), respectively. The median PFS was not reached. Most treatment-related adverse events (TRAEs) were grade 1-2. Grade 3 or above TRAEs were as follows: hypertriglyceridemia (33.3%), hypertension (16.7%), neutropenia (16.7%) and lipase elevated (16.7%). No grade 5 AEs were observed. Conclusions: The preliminary results indicated that anlotinib plus XELOX regimen followed by anlotinib monotherapy as first-line treatment exhibited antitumor efficacy and manageable toxicity for patients with mCRC. The study is still ongoing and the data will be updated subsequently. Clinical trial information: ChiCTR1900028417.
Neoadjuvant chemoradiotherapy with capecitabine in locally advanced rectal cancer: Analysis of prognostic factors.
Authors: Romero Jesus , Sánchez Sofía , Sánchez Arsenio , Alonso Isabel , Benlloch Raquel , Córdoba Sofía , Zapata Irma , Gil Beatriz , López Marta , Hernández María , Pastrana Miguel , Herreros Alberto , Ruíz Casado Ana , Obeso Jorge , Engel Olga 
Published: January 2021

92 Background: Capecitabine-based neoadjuvant chemoradiotherapy is the standard treatment for locally advanced rectal cancer (LARC). The objective of this retrospective study is to analyze overall survival (OS), local relapse free-survival (LRFS), distant metastases free-survival (DMFS) and prognostic factors. Methods: Between 2009 and 2018, 207 patients(p) with LARC has been treated in our hospital with neoadjuvant CRT. Clinical characteristics: Mean age: 65 y (41-87); male:129, female:78; TNM: cT2: 12p, cT3: 176p, cT4: 19p, cN0: 59p, cN1: 106p, cN2: 42p. Treatment: pelvic radiotherapy (45Gy, 1.8Gy/day) plus concomitant capecitabine (852mg/sqm/12h for 28 days). Surgery (mesorectal excision) was carried out 6-8 after the end of CRT. Statistics:Kaplan-Meier and Log-rank test. Results: Mean follow-up: 43 months. Downstaging:104/192 (54%). Pathological complete response:31/192 (16%). Sphincter preservation rate was 82%. Five-year OS, LRFS and DMFS were 89.9%, 93.3% and 81.7%, respectively. Factors predicting shorter 5-y OS were: cT4 (69% vs 91% and 91% for cT1 and CT2, respectively; p=0.027), pT3-4 (85% and 64% vs 100%, 100% and 98% for pT0, pT1 and pT2, respectively; p=0.008), pathological involved nodes (pN+) (77% vs 96%; p=0.001), perineural invasion (PNI) (78% vs 95%; p=0.041), LVI (p<0.001), Ryan 3 (p<0.001), resection margin R1 (67% vs 94% for R0; p<0.001), no pCR (p=0.027) and absence of downstaging (73% vs 97%; p=0.001). Factors associated with poor 5-y DMFS were:pT3-4 ( 70% and 0% vs 96%,88% and 98% for pT0,pT1 and pT2, respectively; p<0.001), pN+ (68% vs 88% for pN0: p<0.001), PNI (64% vs 85%; p=0.036), Ryan 3 (49% vs 96%, 85% and 85% for Ryan 0, 1 and 2, respectively; p<0.001), R1 (33% vs 86% for R0; p<0.001) and absence of downstaging (50% vs 71%; p<0.001). CTCAE 4.0 grade 3 toxicity: 1%. No grade 4 toxicity was seen. Conclusions: CRT with capecitabine provides high rates of survival and sphinter preservation with excellent tolerance. Patients with adverse pathological factors (pT4, pN+, PNI, Ryan 3, R1 and absence of downstaging) have a higher risk of distant metastasis and are more likely to benefit from adjuvant chemotherapy.
Effect of a Multifactorial Intervention on Fracture in Patients With Type 2 Diabetes: Subanalysis of the J-DOIT3 Study
Authors: Sasako Takayoshi , Ueki Kohjiro , Miyake Kana , Okazaki Yukiko , Takeuchi Yasuhiro , Ohashi Yasuo , Noda Mitsuhiko , Kadowaki Takashi 
Published: January 2021

Abstract

Aims
To evaluate the effects of an intensified multifactorial intervention and patient characteristics on the incidence of fractures comorbid with type 2 diabetes.

Methods
Fracture events were identified and analyzed among adverse events reported in the J-DOIT3 study, a multicenter, open-label, randomized, parallel-group trial that was conducted in Japan, in which patients with type 2 diabetes were randomly assigned to receive conventional therapy for glucose, blood pressure, and lipids (targets: HbA1c &lt; 6.9%, blood pressure &lt;130/80 mm Hg, LDL-cholesterol &lt;120mg/dL) or intensive therapy (HbA1c &lt; 6.2%, blood pressure &lt;120/75 mm Hg, LDL-cholesterol &lt;80mg/dL) (ClinicalTrials.gov registration no. NCT00300976).

Results
The cumulative incidence of fractures did not differ between those receiving conventional therapy and those receiving intensive therapy (hazard ratio (HR) 1.15; 95% CI, 0.91-1.47; P = 0.241). Among the potential risk factors, only history of smoking at baseline was significantly associated with the incidence of fractures in men (HR 1.96; 95% CI, 1.04-3.07; P = 0.038). In contrast, the incidence of fractures in women was associated with the FRAX score [%/10 years] at baseline (HR 1.04; 95% CI, 1.02-1.07; P &lt; 0.001) and administration of pioglitazone at 1 year after randomization (HR 1.59; 95% CI, 1.06-2.38; P = 0.025).

Conclusions
Intensified multifactorial intervention may be implemented without increasing the fracture risk in patients with type 2 diabetes. The fracture risk is elevated in those with a history of smoking in men, whereas it is predicted by the FRAX score and is independently elevated with administration of pioglitazone in women.
Changes in Ghrelin and Glucagon following a Low Glycemic Load Diet in Women with PCOS
Authors: Hoover Sarah E , Gower Barbara A , Cedillo Yenni E , Chandler-Laney Paula C , Deemer Sarah E , Goss Amy M 
Published: January 2021

Abstract

Context
Altered satiety hormones in women with polycystic ovarian syndrome (PCOS) may contribute to obesity. Diets with a low glycemic load (GL) may influence appetite-regulating hormones including glucagon and ghrelin.

Objective
To test the hypothesis that following a 4-week, eucaloric low vs high GL diet habituation, a low vs high GL meal will increase glucagon and decrease ghrelin to reflect greater satiety and improve self-reported fullness.

Methods
Secondary analysis of a randomized crossover trial.

Participants
Thirty women diagnosed with PCOS.

Intervention
Participants were provided low (41:19:40% energy from carbohydrate:protein:fat) and high (55:18:27) GL diets for 8 weeks each. At each diet midpoint, a solid meal test was administered to examine postprandial ghrelin, glucagon, glucose, insulin, and self-reported appetite scores.

Results
After 4 weeks, fasting glucagon was greater with the low vs high GL diet (P = .035), and higher fasting glucagon was associated with lesser feelings of hunger (P = .009). Significant diet effects indicate 4-hour glucagon was higher (P &lt; .001) and ghrelin was lower (P = .009) after the low vs high GL meal. A trending time × diet interaction (P = .077) indicates feelings of fullness were greater in the early postprandial phase after the high GL meal, but no differences were observed the late postprandial phase.

Conclusion
These findings suggest after low GL diet habituation, a low GL meal reduces ghrelin and increases glucagon in women with PCOS. Further research is needed to determine the influence of diet composition on ad libitum intake in women with PCOS.
Synthesis of Alkaline-soluble Triazine-based Poly(phenylene sulfide)s with Single/Double Pendant Carboxylic Acid Moieties and Their Application to Refractive Index Contrast Materials
Authors: Higashihara Tomoya , Fu Mao-Chun , Hatakeyama Kouji , Ando Shinji , Takahashi Ryosuke , Ueda Mitsuru 
Published: January 2021

Abstract
The design, synthesis, and optical characterization of refractive-index-contrast (RIC) triazine-based poly(phenylene sulfide)s (PPSs) are investigated. Indeed, novel PPSs with two pendant groups, either tert-butyl (tBu) ester or carboxylic acid groups, at each monomer repeating unit (PPS-2E or PPS-2CA, respectively) were successfully synthesized. PPS-2CA showed high refractive index (n) values of 1.6964 (633 nm) and 1.6714 (940 nm) as well as high δn (increase in the n value by the deprotection of PPS-2E) values of +0.062 (633 nm) and +0.058 (940 nm).
Perspectives of different stakeholders on data use and management in public health emergencies in sub-Saharan Africa: a meeting report
Authors: Munung Nchangwi  Syntia , Chi Primus Che , Abayomi Akin , Afolabi Muhammed O. , Ambe Jennyfer , Bonarwolo Korlia , Kajoleh Francis Kombe , Staunton Ciara , Ujewe Samuel , Yusuf Kabba , Tangwa Godfrey B. 
Published: January 2021

During public health emergencies (PHEs), data are collected and generated from a variety of activities and sources, including but not limited to national public health programs, research and community-based activities. It is critical that these data are rapidly shared in order to facilitate the public health response, epidemic preparedness, as well research during and after the epidemic. Nonetheless, collecting and sharing data during PHEs can be challenging, especially where there are limited resources for public health and research-related activities during a PHE. In a symposium that brought together different stakeholders that were involved in the 2013-2016 Ebola outbreaks in West Africa, meeting attendees shared their perspectives on the values and management of data during PHEs in sub-Saharan Africa. Key factors that could inform and facilitate data management during PHEs in sub-Saharan Africa were discussed, including using data to inform policy decisions and healthcare; a coordinated data collection and management scheme; identifying incentives for data sharing; and equitable data governance mechanism that emphasise principles of reciprocity, transparency and accountability rather that trust between stakeholders or collaborators. Empirical studies are required to explore how these principles could inform best practices for data management and governance during PHE in sub-Saharan Africa.
Clinical results and survivorship of the Mathys Affinis Short, Short Stem Total Shoulder Prosthesis
Authors: Karssiens Timothy James , Gill James Ritchie , Sunil Kumar Karadi Hari , Sjolin Søren Upton 
Published: January 2021

Aims The Mathys Affinis Short is the most frequently used stemless total shoulder prosthesis in the UK. The purpose of this prospective cohort study is to report the survivorship, clinical, and radiological outcomes of the first independent series of the Affinis Short prosthesis. Methods From January 2011 to January 2019, a total of 141 Affinis Short prostheses were implanted in 127 patients by a single surgeon. Mean age at time of surgery was 68 (44 to 89). Minimum one year and maximum eight year follow-up (mean 3.7 years) was analyzed using the Oxford Shoulder Score (OSS) at latest follow-up. Kaplan-Meier survivorship analysis was performed with implant revision as the endpoint. Most recently performed radiographs were reviewed for component radiolucent lines (RLLs) and proximal humeral migration. Results Five shoulders underwent revision surgery (3.5%); three for rotator cuff failure, one for infection, and one for component malposition. Survivorship of the implant was 95.4% (95% confidence interval 90.1% to 97.9%) at five and nine years. Mean OSS improved significantly compared to preoperative values from 19.0 (1 to 35) to 43.3 (7 to 48) (p < 0.001). Radiological analysis was undertaken for 99 shoulders. This revealed humeral RLLs in one case (1%), glenoid RLLs in 15 cases (15.2%), and radiological rotator cuff failure in 22 cases (22.2%). Conclusion This prospective cohort study shows encouraging short- to mid-term survivorship and clinical and radiological results for the Mathys Affinis Short, Short Stem Total Shoulder Prosthesis. Level of Evidence: IV Cite this article: Bone Jt Open 2021;2(1):58–65.
Treatment burden experienced by patients with lung cancer
Authors: El-Turk Nicole , Chou Michael S. H. , Ting Natasha C. H. , Girgis Afaf , Vinod Shalini K. , Bray Victoria , Dobler Claudia C. 
Published: January 2021

Introduction
Patients’ burden from lung cancer treatment is not well researched, but this understanding can facilitate a patient-centred treatment approach. Current models of treatment burden suggest it is influenced by a patient’s perception of their disease and treatment and their capacity to do the work required to treat their disease.

Methods
Sixteen patients and 1 carer who were undergoing or had completed conventional or stereotactic ablative radiotherapy, chemotherapy or immunotherapy for lung cancer in the last 6 months participated in a semi-structured interview. A treatment burden framework was used with three main themes: a) treatment work, b) consequences of treatment and c) psychosocial factors affecting treatment burden.

Results
The majority of patients did not feel unduly burdened by treatment tasks, despite having a large treatment-associated workload. Many saw treatment as a priority, causing them to restructure their life to accommodate for it. Patients wished that they would have been better informed about the lifestyle changes that they would have to make before treatment for lung cancer commenced and that the health service would provide services to assist them with this task.

Discussion
While there was a large burden associated with lung cancer treatment, patients felt motivated and equipped to manage the workload because the disease was considered severe and life-threatening, and the treatment was seen as beneficial. Before initiating treatment for lung cancer, patients should be informed about lifestyle changes they likely have to make and should be offered assistance.
DNA-thioguanine nucleotide as a treatment marker in acute lymphoblastic leukemia patients with NUDT15 variant genotypes
Authors: Ju Hee Young , Lee Ji Won , Cho Hee Won , Hyun Ju Kyung , Ma Youngeun , Yi Eun Sang , Yoo Keon Hee , Sung Ki Woong , Choi Rihwa , Koo Hong Hoe , Lee Soo-Youn 
Published: January 2021

Background
Large inter-individual variations in drug metabolism pose a challenge in determining 6-mercaptopurine (6MP) doses. As the last product of 6MP metabolism, DNA-thioguanine nucleotide (DNA-TGN) could reflect the efficacy of 6MP, especially in patients harboring variants in the 6MP metabolism pathway. The aim of this study was to investigate the clinical significance of DNA-TGN monitoring in Korean pediatric acute lymphoblastic leukemia (ALL) patients, focusing on the NUDT15 genotype.

Methods
The subjects of this study were patients who underwent ALL treatment with 6MP. Tests for the NUDT15 and TPMT genotypes were performed, and prospective DNA-TGN and erythrocyte TGN samples were collected after two weeks or more of 6MP treatment. DNA-TGN was quantified using the liquid chromatography-tandem mass spectrometry method.

Results
A total of 471 DNA-TGN measurements in 71 patients were analyzed, which ranged from 1.0 to 903.1 fmol thioguanine/μg DNA. The 6MP intensity demonstrated a significant relationship with DNA-TGN concentration (P<0.001). Patients harboring NUDT15 variants were treated with a lower dose of 6MP (P<0.001); however, there was no significant difference in DNA-TGN concentration when compared to patients carrying wild-type NUDT15 (P = 0.261). These patients also presented higher variation in DNA-TGN levels (P = 0.002) and DNA-TGN/6MP intensity (P = 0.019) compared to patients carrying wild-type NUDT15. DNA-TGN concentration did not show a significant correlation with WBC count (P = 0.093).

Conclusions
Patients harboring NUDT15 variants demonstrated similar DNA-TGN concentrations even at low doses of 6MP and showed high variability in DNA-TGN. Particularly in patients with NUDT15 variants who need a reduced 6MP dose, DNA-TGN could be applied as a useful marker to monitor the therapeutic effect of 6MP.
Risk factors of heart failure among patients with hypertension attending a tertiary hospital in Ibadan, Nigeria: The RISK-HHF case-control study
Authors: Oguntade Ayodipupo S. , Ajayi IkeOluwapo O. 
Published: January 2021

Aim
Hypertension is the leading cause of heart failure (HF) in sub-Saharan Africa. Preventive public health approach to reduce the scourge of HF must seek to understand the risk factors of HF in at-risk populations. The aim of this study was to characterize the risk factors of HF among patients with hypertension attending a cardiology clinic.

Methods and results
One hundred and one (101) case-control age- and sex-matched pairs were recruited. The study population were adults with a clinical diagnosis of hypertensive HF (cases) and individuals with systemic hypertension without HF. They were interviewed and evaluated for cardiovascular risk factors. Associations between variables were tested with chi square test, Fisher’s exact test and independent sample t test as appropriate. Logistic regression modelling was used to determine the independent risk factors of hypertensive HF (HHF) in the study population while ‘punafcc’ package in stata12 was used to calculate the population attributable fraction (PAF) of the risk factors. Suboptimal medication adherence was the strongest adverse risk factor of HHF (medium adherence aOR: 3.53, 95%CI: 1.35–9.25; low adherence aOR: 9.44, 95%CI: 3.41–26.10) with a PAF of 67% followed by dipstick proteinuria (aOR: 4.22, 95%CI: 1.62–11.02; PAF: 34%) and alcohol consumption/day per 10grams (aOR: 1.23, 95%CI: 1.02–1.49; PAF: 22%). The protective risk factors of HHF were use of calcium channel blockers (aOR 0.25, 95%CI: 0.11–0.59; PAF: 59%), then daily fruits and vegetable consumption (aOR 0.41, 95%CI: 0.17–1.01; PAF: 46%), and eGFR (aOR 0.98, 95%CI: 0.96–0.99; PAF: 5.3%).

Conclusions
The risk factors of HHF are amenable to lifestyle and dietary changes. Public health interventions and preventive cardiovascular care to improve medication adherence, promote fruit and vegetable consumption and reduce alcohol consumption among patients with hypertension are recommended. Renoprotection has utility in the prevention of HF among hypertensives.
Sobre cocaína y embriaguez: ética y estética en Freud y Nietzsche
Authors: Zengotita Alonso 
Published: January 2021

Las temáticas de la influencia de la cocaína en Freud y la embriaguez en Nietzsche han sido escasamente laboradas; cuando lo han sido, en el primero generalmente se ha abordado desde una perspectiva histórica, o relativa al consumo de Freud; en el segundo, como uno más de los elementos que hacen a la concepción del arte –esta última, extensamente trabajada. El objetivo del presente trabajo es dar cuenta que la embriaguez y la influencia de la cocaína, lejos de ser aspectos episódicos, laterales o superados, marcan aquello de la perspectiva estético-ética que es desplegado de modo continuo a lo largo de las obras de Nietzsche y Freud, modelando la conceptualidad y las consideraciones sobre la vida, la guerra, los hombres superiores, la aptitud de analista, la cultura de la época- y en términos más amplios: la relación entre el mundo y el viviente.
Depictions of psychopathology and mental health issues in music: themes and musical genres
Authors: Pavez Fabián , Saura Erika , Pérez Gemma , Marset Pedro 
Published: January 2021

Introduction. In previous communications we have proposed that the analysis of cultural products related to art, and music in particular, can inform us about the social representations of psychiatry and mental illness. This topic is not irrelevant to our clinical practice, since it favors a better understanding about what are the meanings of our profession and its scope of practice for our patients and general population. In this work, we focused on portrayals of psychopathology in music and the musical genres associated.
Objectives. By exploring studies addressing depictions of mental disorders or mental health concerns in music, we intend: - to assess the distribution of psychopathological themes alluded; and - to characterize the most studied musical genres that are associated to portrayals of mental disorders or mental health concerns.
Methods. Starting from a previous systematic review of studies addressing depictions of mental disorders or mental health issues in music, thirty-seven articles are examined. Frequency of portrayed themes and musical genres associated are presented.
Results/Conclusion. As we can expect, references to substance use in music are the most frequently studied. Studies addressing references to 'madness' in music are frequent too, but in a lesser extent. Other mental health issues depicted are: affective disorders; suicide; sexuality and gender; personality disorders; self-destructive behavior; resilience; as well as general links between music and mental illness/psychiatry. Studies addressing substance use are mostly focused on multiple genres (based in popularity rankings). With regards substance use, Rap and Rock are two genres specifically studied. Links between country music, alcohol use and suicide have been described in literature. Rock and Opera are the genres more frequently associated with references to 'madness'.
A cultura do maracatu: subsídios para a educação ambiental nas escolas / The maracatu culture: subsidies for environmental education in schools
Authors: Lima Suênnia Keylla de Araújo , Fernandes Múcio Luiz Banja 
Published: January 2021

A Educação Ambiental deve se realizar de forma diferenciada em cada meio para que se adapte às respectivas realidades, trabalhando com seus problemas específicos e suas soluções próprias em respeito à cultura, aos hábitos, aos aspectos psicológicos, às característica biofísicas e socioeconômicas de cada localidade. Nesse sentido, o estudo descrito neste trabalho buscou investigar as potencialidades da cultura do Maracatu no fortalecimento da prática em Educação Ambiental numa escola de Ensino Médio de Nazaré da Mata–Pernambuco/Brasil. Na investigação, utilizou-se a abordagem quali-quantitativa, seguindo os procedimentos da pesquisa-ação. Os resultados obtidos com a pesquisa permitiram constatar que para que a sala de aula seja um ambiente mais atrativo e significativo para os alunos, é importante que no processo de ensino aprendizagem o professor tome como base a região em que estes se encontram, atrelando-a a sua comunidade, essa prática desenvolverá valores e costumes que levarão à transformação nos aspectos naturais e sociais para a conservação do meio ambiente, necessário à qualidade de vida e a sua sustentabilidade.