bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pembrolizumab Combined With Neoadjuvant Chemotherapy Versus Neoadjuvant Chemoradiotherapy Followed by Surgery for Locally Advanced Oesophageal Squamous Cell Carcinoma: Protocol for a Multicentre, Prospective, Randomized-Controlled, Phase III Clinical Study (Keystone-002)
Authors: Shang Xiaobin , Zhang Wencheng , Zhao Gang , Liang Fei , Zhang Chen , Yue Jie , Duan Xiaofeng , Ma Zhao , Chen Chuangui , Pang Qingsong , Zhang Weihong , Liu Liang , Ren Xiubao , Meng Bin , Zhang Peng , Ma Yegang , Zhang Lin , Li Hecheng , Kang Xiaozheng , Li Yin , Jiang Hongjing 
Published: March 2022

BackgroundTo compare the efficacy and safety of pembrolizumab combined with neoadjuvant chemotherapy (neoCT) versus neoadjuvant chemoradiotherapy (neoCRT) followed by surgery for locally advanced resectable oesophageal squamous cell carcinoma (ESCC).MethodsThis study is a multicentre, prospective, randomized-controlled, phase III clinical study. Eligible ESCC (staging: cT1N2M0 or cT2-3N0-2M0 (stage II/III, high-risk lesions in T2N0M0)) patients will be randomly assigned to either the experimental group (pembrolizumab with neoCT, n = 228) or the control group (neoCRT, n = 114) at a ratio of 2:1. Within 4–6 weeks after preoperative therapy, the McKeown procedure will be performed. Patients in the experimental group will also receive pembrolizumab alone as adjuvant therapy after surgery until 1 year or until the radiographically confirmed PD or other condition indicated for premature termination is observed. The primary endpoint is event-free survival (EFS). The secondary endpoints are 1-, 3-, and 5-year overall survival (OS) and disease-free survival (DFS), short-term outcomes, and quality of life.DiscussionThis is the first prospectively randomized controlled trial designed to compare pembrolizumab plus chemotherapy and chemoradiotherapy as neoadjuvant therapy for resectable ESCC. According to our hypothesis, preoperative pembrolizumab combined with chemotherapy will result in a better tumour response and prolong the survival of patients, with acceptable toxicity. This study started in December 2021, and the enrolment time is estimated to be 2 years.Trial RegistrationThis prospective study has been registered at ClinicalTrials.gov (NCT04807673), March 2021.
The Incidence of Cancer Is Increased in Hospitalized Adult Patients With Obstructive Sleep Apnea in China: A Retrospective Cohort Study
Authors: Xiong Hailin , Lao Miaochan , Wang Longlong , Xu Yanxia , Pei Guo , Lu Bin , Shi Qianping , Chen Jialian , Zhang Shuyi , Ou Qiong 
Published: March 2022

BackgroundThe association between obstructive sleep apnea (OSA) and the incidence and mortality of cancer remain unclear, especially in Asian populations. Thus, this study was conducted to explore the relationship between OSA and the incidence and mortality of cancer in hospitalized patients.MethodsThis retrospective cohort study evaluated inpatients from Guangdong Provincial People’s Hospital for suspected OSA between January 2005 and December 2015. Cancer incidence, all-cause mortality, and cancer mortality and were determined using data from the hospital information system and Centers for Disease Control. Between-group comparisons were carried out by performing a chi-square test and analysis of variance. Kaplan–Meier analysis and the Cox proportional risk model were applied to investigate the association between OSA and cancer incidence and mortality.ResultsOf the 4,623 hospitalized patients included, 3,786 (81.9%) patients were diagnosed with OSA. After a median follow-up of 9.1 years (interquartile range, 9.79–11.44), the incidence of cancer was 6.6% (251/3,786), with lung cancer having the highest incidence at 1.6% (60/3,786). The mortality rate of OSA patients was higher than that of non-OSA patients (16.83% vs.12.78%, p=0.008), but the relationship between apnea-hypopnea index (AHI), oxygen saturation less than 90% (TSat90), and cancer mortality was not statistically significant (p&gt;0.05).The mortality rate for all types of cancer was 2.8% (105/3,786), with lung cancer having the highest mortality rate at 0.8% (32/3,786). The cumulative incidence of cancer in the severe OSA group was 8.2%, which was higher than that in the normal, mild, and moderate OSA groups (P=0.010). Further, the Cox proportional risk regression model showed a progressive enhancement in the risk of cancer incidence as the AHI increased (adjusted hazard ratio [HR]: 1.009 [95% confidence interval (CI): 1.003–1.016], P=0.005). Based on subgroup analysis, the risk of cancer increased as the AHI increased in patients aged &lt;65 years (adjusted HR: 1.019 [95% CI: 1.007–1.031], P=0.002). In addition, the cancer incidence was significantly higher in the severe OSA group than in the normal, mild, and moderate OSA groups (adjusted HR: 2.825 [95% CI: 1.358–5.878], P=0.019).ConclusionThe incidence of cancer is higher in patients with OSA than in non-OSA patients and is significantly positively associated with the severity of OSA. Particularly, for OSA patients aged &lt;65 years, lung cancer is the main cause of death in those with new-onset cancer. Mortality was higher in OSA patients than in non-OSA patients.
The Impact of an Interactive Guidance Intervention on Sustained Social Withdrawal in Preterm Infants in Chile: Randomized Controlled Trial
Authors: Bustamante Loyola Jorge , Pérez Retamal Marcela , Mendiburo-Seguel Andrés , Guedeney Antoine Claude , Salinas González Ricardo , Muñoz Lucia , Cox Melane Horacio , González Mas José Miguel , Simó Teufel Sandra , Morgues Nudman Mónica 
Published: March 2022

BackgroundSustained social withdrawal is a key indicator of child emotional distress and a risk factor for psychological development. Preterm infants have a higher probability of developing sustained social withdrawal than infants born full-term during their first year.ObjectiveTo compare the effect of a behavioral guidance intervention to that of routine pediatric care on sustained social withdrawal behavior in preterm infants.DesignMulticenter randomized clinical trial.ParticipantsNinety nine moderate and late preterm newborns and their parents were recruited and randomized into two groups, i.e., Intervention (n = 49) and Control (n = 50). Both groups attended medical check-ups at 2, 6 and 12 months and were assessed with the Alarm Distress Baby Scale. The intervention group received a standardized behavioral intervention if the neonatologist detected sustained social withdrawal. Also, parents filled out the Edinburgh Postnatal Depression Scale, the modified-Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale-revised.ResultsAt baseline, the prevalence of withdrawal was 4.0% (95% CI: 0.03–14.2) for the control group and 22.4% (95% CI: 13.0–35.9) for the intervention group [OR = 0.22, p = 0.028 (95% CI =0.06–0.84)]. At 6 months, the prevalence was 10.0% (95% CI: 3.9–21.8) for the control group and 6.1% (95% CI: 2.1–16.5) for the intervention group [OR = 2.09, p = 0.318 (95% CI = 0.49–8.88)]. At 12 months, the prevalence was 22.0% (95% CI: 12.8–35.2) for the control group and 4.1% (95% CI: 1.1–13.7) for the intervention group [OR = 6.63, p = 0.018 (95% CI = 1.39–31.71)]. Logistic generalized estimating equation models were performed. The pooled crude OR (considering diagnosis at 6 and 12 months) was 3.54 [p = 0.022 (95% CI = 1.20–10.44); Cohen's d= 0.70]. In the case of pooled adjusted OR, the model considered diagnosis (0 = Withdrawal, 1 = Normal) as the dependent variable, time of evaluation (1= 6 months, 2 = 12 months) and group (0 = Control, 1 = Experimental) as factors. In this case, the pooled adjusted OR was 3.57 [p = 0.022 (95% CI = 1.20–10.65); Cohen's d = 0.70].ConclusionAssessment and intervention of sustained social withdrawal in preterm infants via standardized instruments benefits families by reducing its prevalence, and possible associated negative outcomes.Clinical Trial RegistrationClinicalTrials.gov; https://clinicaltrials.gov/ct2/show/NCT03212547, identifier: NCT03212547.
With or Without Nasal Continuous Positive Airway Pressure During Delayed Cord Clamping in Premature Infants <32 Weeks: A Randomized Controlled Trial Using an Intention-To-Treat Analysis
Authors: Deng Rui , Wu Yan , Xiao Guiyuan , Zhong Xiaoyun , Gong Hua , Chen Wen , Zhou Ligang , Shen Biao , Wang Qi 
Published: March 2022

ObjectiveTo assess whether providing nasal continuous positive airway pressure (nCPAP) during delayed cord clamping is beneficial for preterm infants &lt;32 weeks.Study DesignA randomized controlled trial was performed from March 2020 to May 2021. Premature infants (&lt;32 weeks of gestational age; n = 160) were allocated to receive at least 60 s of delayed cord clamping with nCPAP (DCC+nCPAP; n = 80) or without nCPAP (DCC only; n = 80). For both groups, after the umbilical cord was clamped, the infants were carried immediately to the resuscitation room to continue receiving standard transition. The primary outcome was the mechanical ventilation (MV) rate within 24 h of life. The measurements related to early respiratory support effect before cord clamping including positive end-expiratory pressure (PEEP) and FiO2 during transition/leaving the delivery room, intubation rate during transition, pulmonary surfactant (PS) administration ≥2 times after birth, extubation failure, and incidence of bronchopulmonary dysplasia (BPD) were collected as the secondary outcomes. Furthermore, other neonatal short-term outcomes and safety assessment were also included.ResultsThe measurements were calculated using intention-to-treat analysis. The median time for cord clamping were 60 s with interquartile range (IQR) (60.00–60.00 vs. 60.00–70.00) in both groups. There were no difference in the primary outcome of MV rate within 24 h of life (p = 0.184). The arterial blood gas pH at 1 h after birth in the DCC+nCPAP group was 7.28 ± 0.08 vs. 7.25 ± 0.07 in the control group (mean difference = 0.01, 95% CI: −0.01–0.05, p = 0.052), which approached statistical significance. There was no significant statistical difference in the other short-term neonatal outcomes and the safety indicators between the two groups.ConclusionsOur study showed that delayed cord clamping with nCPAP was feasible and safe in preterm infants with gestational age &lt;32 weeks. Although there was a trend toward a higher arterial blood gas pH at 1 h after birth in the DCC+nCPAP group, DCC+nCPAP neither resulted in a corresponding measurable clinical improvement nor did it reduce subsequent neonatal morbidity. A larger multi-center study including more infants with gestational age &lt;28 weeks is needed to evaluate the full effects of DCC in combination with nCPAP in preterm infants.
Effect of Dezocine on Hemodynamic Indexes of Postoperative Patients With Traumatic Brain Injury (TBI)---A Pilot Study
Authors: Wang Xuejian , Chen Yang , Wang Zhifeng , Zhang Yi , Cui Zhiming , Sun Chen 
Published: March 2022

Background: Due to pain and other stimuli, patients with traumatic brain injury (TBI) after surgery show excited Sympathetic Nervous system, increased intracranial pressure, brain tissue swelling, intracranial hemorrhage, or reduced cerebral perfusion pressure, seriously threatening the life and prognosis of patients. The effect of dezocine on postoperative analgesia after TBI remains largely undetermined.Objective: In the present study, we aimed to investigate the efficacy and safety of dezocine in postoperative sedative and analgesic therapy for a craniocerebral injury.Methods: The patients were randomly divided into two groups (n = 40) as follows: dezocine group (Group A) and control group (Group B). Electrocardiography (ECG), heart rate (HR), blood pressure, and oxygen saturation (SpO2) were routinely monitored after postoperative return to the ward. Both groups were initially injected with 5 mg·kg−1·h−1 propofol to maintain sedation, and the dose was adjusted according to the patient’s condition. Vital signs of patients were recorded at T1 (the base value when arriving at the ward), T2 (before the sedative agent was used) and T3 (use of dezocine or 0.9% saline solution for 8 h), T4 (use for 1 day), T5 (use for 3 days), T6 (termination of dezocine or 0.9% saline solution for 1 day), and T7 (termination for 3 days), and mean arterial pressure (MAP) and HR values were also recorded. The total amount of propofol, total fluid inflow, blood loss, and urine output were recorded within 24 h. The number of coughs of each patient was recorded within 1 day after entry, and the incidence of adverse events, such as insufficient oxygenation (SaO2 reduced by about 5% from the base value), hypotension, bradycardia, laryngospasm, bronchospasm, and so on, was assessed.Results: Compared with the control group (group B), the hemodynamics of the dezocine group (group A) was more stable, there were significant differences in MAP and HR (p &lt; 0.05), and the stress response was milder. The total amount of propofol, total fluid inflow, blood loss, and urine volume of the dezocine group were significantly improved compared with the control group (p &lt; 0.05). Moreover, the incidence of adverse events, such as cough, in the dezocine group was significantly reduced compared with the control group (p &lt; 0.05).Conclusions: Dezocine, as a drug with a strong analgesic effect and obvious sedative effect, was suitable for craniocervical surgery, and it could significantly improve the stability of airway and hemodynamics in TBI patients during anesthesia recovery.
Medicinal Earthworm: Speciation and Bioaccessibility of Arsenic and Its Potential Health Risks
Authors: Li Yaolei , Li Hailiang , Zan Ke , Wang Ying , Zuo Tiantian , Jin Hongyu , Zhang Bing , Ma Shuangcheng 
Published: March 2022

Arsenic in environmental health has caused public concerns all over the world. However, high levels of arsenic residues in medicinal animals have not received enough attention. Medicinal earthworms are consumed widely in China, but its arsenic potential health risks to humans are unknown. This work investigated the total concentration, bioaccessibility, and speciation of arsenic in earthworms by ICP-MS and HPLC-ICP-MS to evaluate its potential health risks to humans. Arsenic was found in all earthworms at concentrations ranging from 0.4 to 53.6 mg kg−1. The bioaccessibility of arsenic (bAs) varied significantly and ranged from 12.1 to 69.1%, with inorganic arsenic (iAs, including As(III) and As(V)) as the predominant species. Furthermore, a small amount of arsenobetaine (AB) was found. The estimated daily intake dose (EDI), hazard quotient (HQ), and carcinogenic risk (CR) of arsenic in most of the samples exceeded the safe threshold level. Results from this study indicated that the potential health risks by the consumption of earthworms may not be negligible. Herein, recommendations for the use of earthworms and regulatory recommendations for arsenic limit standards were proposed. This study reminds us that more control and monitoring of arsenic in medicinal animals should be carried out.
How Our Continuing Studies of the Pre-clinical Inbred Mouse Models of Mesothelioma Have Influenced the Development of New Therapies
Authors: Robinson Bruce W.S. , Redwood Alec J. , Creaney Jenette 
Published: March 2022

Asbestos-induced preclinical mouse models of mesothelioma produce tumors that are very similar to those that develop in humans and thus represent an ideal platform to study this rare, universally fatal tumor type. Our team and a number of other research groups have established such models as a stepping stone to new treatments, including chemotherapy, immunotherapy and other approaches that have been/are being translated into clinical trials. In some cases this work has led to changes in mesothelioma treatment practice and over the last 30 years these models and studies have led to trials which have improved the response rate in mesothelioma from less than 10% to over 50%. Mouse models have had a vital role in that improvement and will continue to play a key role in the future success of mesothelioma immunotherapy. In this review we focus only on these original inbred mouse models, the large number of preclinical studies conducted using them and their contribution to current and future clinical therapy for mesothelioma.
Experiences of Clinical Clerkship Students With Mindfulness-Based Stress Reduction: A Qualitative Study on Long-Term Effects
Authors: van Dijk Inge , van Beek Maria H. C. T. , Arts-de Jong Marieke , Lucassen Peter L. B. J. , van Weel Chris , Speckens Anne E. M. 
Published: March 2022

PurposeTo explore the mindfulness practice, its long-term effects, facilitators and barriers, in clinical clerkship students 2 years after participation in an 8-week mindfulness-based stress reduction (MBSR) training.MethodA qualitative study was performed by semi-structured in-depth interviews with 16 clinical clerkship students selected by purposive sampling. Students had participated in a MBSR training 2 years before and were asked about their current mindfulness practice, and the long-term effects of the MBSR training. Thematic analysis was conducted using the constant comparison method. Data saturation was reached after 16 interviews.ResultsMost interviewees were still engaged in regular, predominantly informal, mindfulness practice, although some discontinued mindfulness practice and reported an “unchanged lifestyle.” Three main themes came forward; (1) “focused attention and open awareness” during daily activities as core elements of long-term mindfulness practice; (2) “changes in behavior and coping” that resulted from taking a pause, reflecting, recognizing automatic behavioral patterns and making space for a conscious response; (3) “integration in personal and professional life” by enhanced enjoyment of daily activities, improved work-life-balance and making different career choices. Barriers and facilitators in starting and maintaining mindfulness practice were (1) understanding and intention as “pre-conditions”; (2) practical, personal, and professional factors of students in maintaining practice.ConclusionTwo years after participation in a MBSR training, many interviewees were still engaged in (mostly informal) mindfulness practice contributing to both personal and professional changes. In light of the high clerkship demands, MBSR training could be a valuable addition to medical curricula, supporting medical students in developing necessary competencies to become well-balanced professionals.
Psychometric Properties of a Cultural Adapted Version of the Assessment of Identity Development in Adolescence in Panama
Authors: González Flores Sergio , Goth Kirstin , Díaz-Hernandez Ruben A. 
Published: March 2022

The Assessment of Identity Development in Adolescence (AIDA) is a self-report instrument to detect pathological development of Identity. In Panamá, psychometric instruments for assessment of psychopathology in adolescence are lacking. Our aim was to develop a valid and reliable version of the AIDA Inventory for Panamanian Population. AIDA was adapted to Spanish considering cultural aspects of Panamanian population. Two pilot tests were performed prior to main test to assess item-total correlation at subscale, primary scale and total scale levels and internal consistency at subscale level. A mixed sample of students and PD patients (N = 315) completed the AIDA inventory, the “Strength and Difficulties Questionnaire” and “Defense Style Questionnaire−40.” AIDA was retested in a sub sample from school population (n = 98). The Structured Clinical Interview for Axis II Disorders was used for diagnosis of personality disorders in the patient sample (n = 25). Psychometric properties were tested to assess internal consistency, reliability, factorial validity, convergent validity, and criterion validity. AIDA Panama showed excellent internal consistency for the total scale Identity Diffusion with Cronbach's α:0.94 and a retest reliability of 0.84. A Bifactorial CFA was modeled to assess the dimensionality of the inventory. The proportion between OmegaH and Omega at total scales 96% of the variance is explained by a general factor. Furthermore, the Explained Common Variance for the General Factor is 73% supporting unidimensionality. In line with theory, AIDA total scale showed a high positive correlation (r = 0.67) with Total Difficulties scale and high positive correlation (r = 0.71) with Immature Defense scale. The AIDA total score differed highly significant (p = 0.000) between the patient sample and the students with a large effect size (d = 1.02).ConclusionThe adaptation and validation of AIDA for Panamanian adolescent population was successful with good psychometric properties and significant correlations with related psychopathological constructs. AIDA showed high clinical validity by providing a valid discrimination between the school sample and a diagnosed PD sample, in line with the assumption that impaired identity functioning is at the core of personality disorders, especially in adolescence.
Atypical Sensory Processing Is Associated With Lower Body Mass Index and Increased Eating Disturbance in Individuals With Anorexia Nervosa
Authors: Saure Emma , Lepistö-Paisley Tuulia , Raevuori Anu , Laasonen Marja 
Published: March 2022

Background:Elevated autism spectrum disorder (ASD) traits are associated with anorexia nervosa (AN). Conversely, eating disturbances, which are core characteristics of AN, are common in ASD. Among individuals with ASD, atypical sensory processing is associated with eating disturbance. Because AN and ASD appear to overlap, it would be crucial to understand whether sensory processing atypicality exist also in AN. Further, it would be essential to find if atypical sensory processing is associated with eating disturbances in individuals with AN, since treatment modifications may be needed. We therefore aimed to examine whether atypical sensory processing is associated with AN and its core characteristics.MethodsParticipants of the current study included 42 individuals with AN and 40 healthy controls (HCs). All participants were adult women. Sensory processing, other ASD traits, and eating disorder symptoms were assessed with self-report questionnaires.ResultsIndividuals with AN reported lower registration, decreased sensation seeking, increased sensory sensitivity, and increased sensation avoiding compared to HCs. When analyzing groups with restrictive AN (AN-R) and binge-purge type AN (AN-BP) separately, only individuals with AN-R exhibited decreased sensation seeking, and only those with AN-BP exhibited lower registration. After controlling for body mass index as a covariate, group differences remained significant only in sensory sensitivity between individuals with AN and HCs. Increased atypical sensory processing predicted lower body mass index and increased disordered eating.ConclusionResults suggest that sensory processing appears to differ between AN and HC women, and AN subtypes may exhibit distinct sensory processing atypicality. Sensory sensitivity may be stable traits whereas other aspects of atypical sensory processing may be related to acute AN. Atypical sensory processing may contribute to the severity of AN, and thus it is crucial to recognize sensory processing differences when treating individuals with AN.