bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy of neoadjuvant hyperthermic intraperitoneal chemotherapy in advanced high-grade serous ovarian cancer (the NHIPEC trial): study protocol for a randomised controlled trial
Authors: Wu Miao-Fang , Wang Li-Juan , Ye Yan-Fang , Liu Chang-Hao , Lu Huai-Wu , Yao Ting-Ting , Zhang Bing-Zhong , Chen Qing , Li Ji-Bin , Peng Yong-Pai , Zhou Hui , Lin Zhong-Qiu , Li Jing 
Published: December 2021

BackgroundNeoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone.MethodsThis study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60–75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.Ethics approval and disseminationThis study was approved by the Ethics Committee of Sun Yat-sen Memorial Hospital (approval number: 2020-ky-050). Results will be submitted to peer-reviewed journals and presented at national and international conferences.Trial registration numberChiCTR2000038173.
Impact of COVID-19 on mobility and participation of older adults living in Hamilton, Ontario, Canada: a multimethod cohort design protocol
Authors: Beauchamp Marla K , Vrkljan Brenda , Kirkwood Renata , Vesnaver Elisabeth , Macedo Luciana G , Keller Heather , Astephen-Wilson Janie , Sohel Nazmul , Noble Tara , Dietrich Nicholas , Gardner Paula , Newbold K Bruce , Scott Darren 
Published: December 2021

IntroductionThe novel COVID-19 required many countries to impose public health measures that likely impacted the participation and mobility of community-dwelling older adults. This protocol details a multimethod cohort design undertaken to describe short-term and medium-term changes to the mobility and participation of older Canadians living in the community rather than retirement facilities during the COVID-19 pandemic.Methods and analysisA longitudinal telephone (or online)-administered survey is being conducted with a random sample of older adults living within 20 km of McMaster University, Hamilton, Ontario, Canada, identified from census dissemination areas. Baseline data collection of community-dwelling older adults aged 65 years and over began in May 2020 with follow-ups at 3, 6, 9 and 12 months. The Late-Life Function and Disability Instrument and global rating of change anchors are the primary outcomes of interest. A subsample of respondents will participate in open-ended, semistructured interviews conducted over the telephone or through video-conference, to explore participants’ lived experiences with respect to their mobility and participation during the pandemic. Descriptive statistics and quantitative approaches will be used to determine changes in mobility and social and personal participation, and associated personal and environmental factors. For the interviews, qualitative data will be analysed using descriptive phenomenology.Ethics and disseminationApproval was obtained from the Hamilton Integrated Research Ethics Board of McMaster University (2020-10814-GRA). This study may inform the design of programmes that can support community-dwelling older adults during and after the COVID-19 pandemic. Findings will be disseminated through peer-reviewed publications and conferences focused on ageing.
Potential of heart fatty-acid binding protein, neurofilament light, interleukin-10 and S100 calcium-binding protein B in the acute diagnostics and severity assessment of traumatic brain injury
Authors: Koivikko Pia , Posti Jussi P , Mohammadian Mehrbod , Lagerstedt Linnea , Azurmendi Leire , Hossain Iftakher , Katila Ari J , Menon David , Newcombe Virginia F J , Hutchinson Peter John , Maanpää Henna-Riikka , Tallus Jussi , Zetterberg Henrik , Blennow Kaj , Tenovuo Olli , Sanchez Jean-Charles , Takala Riikka S K 
Published: December 2021

BackgroundThere is substantial interest in blood biomarkers as fast and objective diagnostic tools for traumatic brain injury (TBI) in the acute setting.MethodsAdult patients (≥18) with TBI of any severity and indications for CT scanning and orthopaedic injury controls were prospectively recruited during 2011–2013 at Turku University Hospital, Finland. The severity of TBI was classified with GCS: GCS 13–15 was classified as mild (mTBI); GCS 9–12 as moderate (moTBI) and GCS 3–8 as severe (sTBI). Serum samples were collected within 24 hours of admission and biomarker levels analysed with high-performance kits. The ability of biomarkers to distinguish between severity of TBI and CT-positive and CT-negative patients was assessed.ResultsAmong 189 patients recruited, neurofilament light (NF-L) was obtained from 175 patients with TBI and 40 controls. S100 calcium-binding protein B (S100B), heart fatty-acid binding protein (H-FABP) and interleukin-10 (IL-10) were analysed for 184 patients with TBI and 39 controls. There were statistically significant differences between levels of all biomarkers between the severity classes, but none of the biomarkers distinguished patients with moTBI from patients with sTBI. Patients with mTBI discharged from the ED had lower levels of IL-10 (0.26, IQR=0.21, 0.39 pg/mL), H-FABP (4.15, IQR=2.72, 5.83 ng/mL) and NF-L (8.6, IQR=6.35, 15.98 pg/mL) compared with those admitted to the neurosurgical ward, IL-10 (0.55, IQR=0.31, 1.42 pg/mL), H-FABP (6.022, IQR=4.19, 20.72 ng/mL) and NF-L (13.95, IQR=8.33, 19.93 pg/mL). We observed higher levels of H-FABP and NF-L in older patients with mTBI. None of the biomarkers or their combinations was able to distinguish CT-positive (n=36) or CT-negative (n=58) patients with mTBI from controls.ConclusionsS100B, H-FABP, NF-L and IL-10 levels in patients with mTBI were significantly lower than in patients with moTBI and sTBI but alone or in combination, were unable to distinguish patients with mTBI from orthopaedic controls. This suggests these biomarkers cannot be used alone to diagnose mTBI in trauma patients in the acute setting.
Redefining WILD syndrome: a primary lymphatic dysplasia with congenital multisegmental lymphoedema, cutaneous lymphovascular malformation, CD4 lymphopaenia and warts
Authors: Mansour Sahar , Josephs Katherine S , Ostergaard Pia , Gordon Kristiana , Van Zanten Malou , Pearce Julian , Jeffery Steve , Keeley Vaughan , Riches Katie , Kreuter Alexander , Wieland Ulrike , Hägerling René , Ratnam Lakshmi , Sackey Ege , Grigoriadis Dionysios , Ho Bernard , Smith Frances , Rauter Elisabeth , Mortimer Peter , Macallan Derek 
Published: December 2021

BackgroundPrimary lymphoedema (PL) syndromes are increasingly recognised as presentations of complex genetic disease, with at least 20 identified causative genes. Recognition of clinical patterns is key to diagnosis, research and therapeutics. The defining criteria for one such clinical syndrome, ‘WILD syndrome’ (Warts,Immunodeficiency,Lymphoedema and anogenitalDysplasia), have previously depended on a single case report.Methods and resultsWe present 21 patients (including the first described case) with similar clinical and immunological phenotypes. All had PL affecting multiple segments, with systemic involvement (intestinal lymphangiectasia/pleural or pericardial effusions) in 70% (n=14/20). Most (n=20, 95%) had a distinctive cutaneous lymphovascular malformation on the upper anterior chest wall. Some (n=10, 48%) also had hyperpigmented lesions resembling epidermal naevi (but probably lymphatic in origin). Warts were common (n=17, 81%) and often refractory. In contrast to the previous case report, anogenital dysplasia was uncommon—only found in two further cases (total n=3, 14%). Low CD4 counts and CD4:CD8 ratios typified the syndrome (17 of 19, 89%), but monocyte counts were universally normal, unlikeGATA2deficiency.ConclusionWILD syndrome is a previously unrecognised, underdiagnosed generalised PL syndrome. Based on this case series, we redefine WILD as ‘Warts,Immunodeficiency, andLymphaticDysplasia’ and suggest specific diagnostic criteria. The essential criterion is congenital multisegmental PL in a ‘mosaic’ distribution. The major diagnostic features are recurrent warts, cutaneous lymphovascular malformations, systemic involvement (lymphatic dysplasia), genital swelling and CD4 lymphopaenia with normal monocyte counts. The absence of family history suggests a sporadic condition, and the random distribution of swelling implicates mosaic postzygotic mutation as the cause.
Monitoring of Neuroendocrine Changes in Acute Stage of Severe Craniocerebral Injury by Transcranial Doppler Ultrasound Image Features Based on Artificial Intelligence Algorithm
Authors: Wang Tao , Chen Yizhu , Du Hangxiang , Liu Yongan , Zhang Lidi , Meng Mei 
Published: December 2021

This study was aimed at exploring the application value of transcranial Doppler (TCD) based on artificial intelligence algorithm in monitoring the neuroendocrine changes in patients with severe head injury in the acute phase; 80 patients with severe brain injury were included in this study as the study subjects, and they were randomly divided into the control group (conventional TCD) and the experimental group (algorithm-optimized TCD), 40 patients in each group. An artificial intelligence neighborhood segmentation algorithm for TCD images was designed to comprehensively evaluate the application value of this algorithm by measuring the TCD image area segmentation error and running time of this algorithm. In addition, the Glasgow coma scale (GCS) and each neuroendocrine hormone level were used to assess the neuroendocrine status of the patients. The results showed that the running time of the artificial intelligence neighborhood segmentation algorithm for TCD was

3.14
±
1.02

s

, which was significantly shorter than

32.23
±
9.56

s

of traditional convolutional neural network (CNN) algorithms (

P
<
0.05

). The false rejection rate (FRR) of TCD image area segmentation of this algorithm was significantly reduced, and the false acceptance rate (FAR) and true acceptance rate (TAR) were significantly increased (

P
<
0.05

). The consistent rate of the GCS score and Doppler ultrasound imaging diagnosis results in the experimental group was 93.8%, which was significantly higher than the 80.3% in the control group (

P
<
0.05

). The consistency rate of Doppler ultrasound imaging diagnosis results of patients in the experimental group with abnormal levels of follicle stimulating hormone (FSH), prolactin (PRL), growth hormone (GH), adrenocorticotropic hormone (ACTH), and thyroid stimulating hormone (TSH) was significantly higher than that of the control group (

P
<
0.05

). In summary, the artificial intelligence neighborhood segmentation algorithm can significantly shorten the processing time of the TCD image and reduce the segmentation error of the image area, which significantly improves the monitoring level of TCD for patients with severe craniocerebral injury and has good clinical application value.
Plasma S-Adenosylmethionine Is Associated with Lung Injury in COVID-19
Authors: Kryukov Evgeny Vladimirovich , Ivanov Alexander Vladimirovich , Karpov Vladimir Olegovich , Vasil’evich Aleksandrin Valery , Dygai Alexander Mikhaylovich , Kruglova Maria Petrovna , Kostiuchenko Gennady Ivanovich , Kazakov Sergei Petrovich , Kubatiev Aslan Amirkhanovich 
Published: December 2021

Objective. S-Adenosylmethionine (SAM) and S-adenosylhomocysteine (SAH) are indicators of global transmethylation and may play an important role as markers of severity of COVID-19. Methods. The levels of plasma SAM and SAH were determined in patients admitted with COVID-19 (

n
=
56

,

mean

age
=
61

). Lung injury was identified by computed tomography (CT) in accordance with the CT0-4 classification. Results. SAM was found to be a potential marker of lung damage risk in COVID-19 patients (

SAM
>
80

nM

; CT3,4 vs. CT 0-2: relative ratio (RR) was 3.0;

p
=
0.0029

).

SAM
/
SAH
>
6.0

was also found to be a marker of lung injury (CT2-4 vs. CT0,1:

RR
=
3.47

,

p
=
0.0004

). There was a negative association between SAM and glutathione level (

ρ
=
−
0.343

,

p
=
0.011

). Interleukin-6 (IL-6) levels were associated with SAM (

ρ
=
0.44

,

p
=
0.01

) and SAH (

ρ
=
0.534

,

p
=
0.001

) levels. Conclusions. A high SAM level and high methylation index are associated with the risk of lung injury in patients with COVID-19. The association of SAM with IL-6 and glutathione indicates an important role of transmethylation in the development of cytokine imbalance and oxidative stress in patients with COVID-19.
Factors Associated With Racial and Ethnic Diversity Among Heart Failure Trial Participants: A Systematic Bibliometric Review
Authors: Wei Sunny , Le NhatChinh , Zhu Jie Wei , Breathett Khadijah , Greene Stephen J. , Mamas Mamas A. , Zannad Faiez , Van Spall Harriette G.C. 
Published: December 2021

Background:
Heart failure has a disproportionate burden on patients who are Black, Indigenous, and people of color (BIPOC), but not much is known about representation of these groups in randomized controlled trials (RCTs). We explored temporal trends in and RCT factors associated with the reporting of race and ethnicity data and the enrollment of BIPOC in heart failure RCTs.

Methods:
We searched MEDLINE, EMBASE, and CINAHL for heart failure RCTs published in journals with an impact factor ≥10 between January 1, 2000 and June 17, 2020. We used the Cochran-Armitage and Jonchkeere-Terpstra tests to examine temporal trends, and multivariable regression to assess the association between trial characteristics and outcomes.

Results:

Of 414 RCTs meeting inclusion criteria, only 157 (37.9% [95% CI, 33.2%–2.8%]) reported race and ethnicity data. Among 158 200 participants in these 157 RCTs, 29 512 (18.7% [95% CI, 18.5%–18.9%]) were BIPOC. There was a temporal increase in reporting of race and ethnicity data (29.5% in 2000–2003 to 54.7% in 2016–2020,
P
<0.001) and in enrollment of BIPOC (14.4% in 2000–2003 to 22.2% in 2016–2020,
P
=0.038). Trial leadership by a woman was independently associated with twice the odds of reporting race and ethnicity data (odds ratio, 2.0 [95% CI, 1.1–3.8];
P
=0.028) and an 8.4% increase (95% CI, 1.9%–15.0%;
P
=0.013) in BIPOC enrollment.

Conclusions:
A minority of heart failure RCTs reported race and ethnicity data, and among these, BIPOC were under-enrolled relative to disease distribution. Both reporting of race and ethnicity as well as enrollment of BIPOC increased between 2000 and 2020. After multivariable adjustment, trials led by women had greater odds of reporting race and ethnicity and enrolling BIPOC.

Registration:

URL:
https://www.crd.york.ac.uk/PROSPERO/
; Unique identifier: CRD42021237497.
Association of Frailty With Treatment Selection and Long‐Term Outcomes Among Patients With Chronic Limb‐Threatening Ischemia
Authors: Butala Neel M. , Raja Aishwarya , Xu Jiaman , Strom Jordan B. , Schermerhorn Marc , Beckman Joshua A. , Shishehbor Mehdi H. , Shen Changyu , Yeh Robert W. , Secemsky Eric A. 
Published: December 2021

Background
The optimal treatment strategy for patients with chronic limb‐threatening ischemia (CLTI) is often unclear. Frailty has emerged as an important factor that can identify patients at greater risk of poor outcomes and guide treatment selection, but few studies have explored its utility among the CLTI population. We examine the association of a health record‐based frailty measure with treatment choice and long‐term outcomes among patients hospitalized with CLTI.

Methods and Results
We included patients aged >65 years hospitalized with CLTI in the Medicare Provider Analysis and Review data set between October 1, 2009 and September 30, 2015. The primary exposure was frailty, defined by the Claims‐based Frailty Indicator. Baseline frailty status and revascularization choice were examined using logistic regression. Cox proportional hazards regression was used to determine the association between frailty and death or amputation, stratifying by treatment strategy. Of 85 060 patients, 35 484 (42%) were classified as frail. Frail patients had lower likelihood of revascularization (adjusted odds ratio [OR], 0.78; 95% CI, 0.75‒0.82). Among those revascularized, frailty was associated with lower likelihood of surgical versus endovascular treatment (adjusted OR, 0.76; CI, 0.72‒0.81). Frail patients experienced increased risk of amputation or death, regardless of revascularization status (revascularized: adjusted hazard ratio [HR], 1.34; CI, 1.30‒1.38; non‐revascularized: adjusted HR, 1.22; CI, 1.17‒1.27). Among those revascularized, frailty was independently associated with amputation or death irrespective of revascularization strategy (surgical: adjusted HR, 1.36; CI, 1.31‒1.42; endovascular: aHR, 1.29; CI, 1.243‒1.35).

Conclusions
Among patients hospitalized with CLTI, frailty is an important independent predictor of revascularization strategy and longitudinal adverse outcomes.
Model Based or Model Free? Comparing Adaptive Methods for Estimating Thresholds in Neuroscience
Authors: Audiffren Julien , Bresciani Jean-Pierre 
Published: December 2021

Abstract
The quantification of human perception through the study of psychometric functions Ψ is one of the pillars of experimental psychophysics. In particular, the evaluation of the threshold is at the heart of many neuroscience and cognitive psychology studies, and a wide range of adaptive procedures has been developed to improve its estimation. However, these procedures are often implicitly based on different mathematical assumptions on the psychometric function, and unfortunately, these assumptions cannot always be validated prior to data collection. This raises questions about the accuracy of the estimator produced using the different procedures. In the study we examine in this letter, we compare five adaptive procedures commonly used in psychophysics to estimate the threshold: Dichotomous Optimistic Search (DOS), Staircase, PsiMethod, Gaussian Processes, and QuestPlus. These procedures range from model-based methods, such as the PsiMethod, which relies on strong assumptions regarding the shape of Ψ, to model-free methods, such as DOS, for which assumptions are minimal. The comparisons are performed using simulations of multiple experiments, with psychometric functions of various complexity. The results show that while model-based methods perform well when Ψ is an ideal psychometric function, model-free methods rapidly outshine them when Ψ deviates from this model, as, for instance, when Ψ is a beta cumulative distribution function. Our results highlight the importance of carefully choosing the most appropriate method depending on the context.
Language Variation in Mandarin as a Heritage Language: Subject Personal Pronouns
Authors: Zhang Xinye 
Published: December 2021

Abstract
Because of limited language input, different dominant languages, and learners’ differing backgrounds, the acquisition of heritage languages is distinguished from the acquisition of L1 and L2. Few studies of Chinese as a Heritage Language (CHL) have explored whether students can acquire native-like sociolinguistic competence and language-specific variables with educational input. Based on a sociolinguistic variationist perspective, this study investigates the acquisition of variation between null and overt subject personal pronouns (SPP s) by heritage learners in an undergraduate-level Mandarin program. A total of 11,970 tokens were collected through classroom observation, sociolinguistic interviews, and narratives. Measuring mixed-effects logistic regression with Rbrul (Johnson, 2009), results show that the overall usage pattern of SPP s by CHL students largely resembled that in the input provided by the language program. Results also demonstrate that linguistic constraints including coreference, person and number, and verb type, and social factors such as discourse context, first languages, course level, and age of arrival had a significant effect on SPP expression by CHL learners. Implications for CHL development and variationist studies in heritage languages are discussed.
A Novel and Simple Method of Managing Thoracic Esophageal Perforation: The “ASSIST” Approach
Authors: Chu Quyen D. , Candal Raquel , White Robert K. 
Published: December 2021

Introduction Thoracic esophageal perforation (TEP) remains a therapeutic challenge that carries with it a high mortality. Because of its rare occurrence and management is complex, most patients are referred to higher level of care. Management is variable, ranging from a stent placement to an esophagectomy. Unfortunately, stent capabilities may not be readily available and the different surgical approaches can be complex, time-consuming, and demanding on a septic patient. Given these challenges, we conceived a simple 6-step (1) Antibiotics, (2) Suture the cervical esophagus with a 0- chromic, (3) Suture the abdominal esophagus with a 3-0 chromic, (4) Insert nasogastric tube above the sutured cervical esophagus, (5) Support nutrition with a jejunostomy, and (6) Tubes (placement of bilateral chest tubes). Methods Six consecutive septic patients with TEP who underwent an ASSIST approach were evaluated. On day 14, patients were taken to the OR for an esophagogastroduodenoscopy to open the cervical and hiatal esophageal closure. Patients then underwent a repeat barium swallow prior to resuming per oral (PO) intake. Results Sepsis resolved in all patients. One patient died of advanced cirrhosis. None of the living patients required additional surgery and all resumed a normal diet. Conclusions The “ASSIST” method is a viable option for managing septic patients with thoracic esophageal perforation. This novel approach does not require a high level of technical expertise and conceivably be performed by most centers without the need for immediate transfer to specialized facilities.