bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prospective, randomized, double-blind phase 2B trial of the TLPO and TLPLDC vaccines to prevent recurrence of resected stage III/IV melanoma: a prespecified 36-month analysis
Authors: Carpenter Elizabeth Lee , Van Decar Spencer , Adams Alexandra M , O’Shea Anne E , McCarthy Patrick , Chick Robert Connor , Clifton Guy Travis , Vreeland Timothy , Valdera Franklin A , Tiwari Ankur , Hale Diane , Kemp Bohan Phillip , Hickerson Annelies , Smolinsky Todd , Thomas Katryna , Cindass Jessica , Hyngstrom John , Berger Adam C , Jakub James , Sussman Jeffrey J , Shaheen Montaser F , Yu Xianzhong , Wagner Thomas E , Faries Mark , Peoples George E 
Published: August 2023

BackgroundThe tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is made by ex vivo priming matured autologous dendritic cells (DCs) with yeast cell wall particles (YCWPs) loaded with autologous tumor lysate (TL). The tumor lysate, particle only (TLPO) vaccine uses autologous TL-loaded YCWPs coated with silicate for in vivo DC loading. Here we report the 36-month prespecified analyses of this prospective, randomized, double-blind trial investigating the ability of the TLPO and TLPLDC (±granulocyte-colony stimulating factor (G-CSF)) vaccines to prevent melanoma recurrence in high-risk patients.MethodsPatients with clinically disease-free stage III/IV melanoma were randomized 2:1 initially to TLPLDC versus placebo (n=124) and subsequently TLPO versus TLPLDC (n=63). All patients were randomized and blinded; however, the placebo control arm was replaced in the second randomization scheme with another novel vaccine; some analyses in this paper therefore reflect a combination of the two randomization schemes. Patients receiving the TLPLDC vaccine were further divided by their method of DC harvest (with or without G-CSF pretreatment); this was not randomized. The use of standard of care checkpoint inhibitors was not stratified between groups. Safety was assessed and Kaplan-Meier and log-rank analyses compared disease-free (DFS) and overall survival (OS).ResultsAfter combining the two randomization processes, a total of 187 patients were allocated between treatment arms: placebo (n=41), TLPLDC (n=103), or TLPO (n=43). The allocation among arms created by the addition of patients from the two separate randomization schemes does not reflect concurrent randomization among all treatment arms. TLPLDC was further divided by use of G-CSF in DC harvest: no G-CSF (TLPLDC) (n=47) and with G-CSF (TLPLDC+G) (n=56). Median follow-up was 35.8 months. Only two patients experienced a related adverse event ≥grade 3, one each in the TLPLDC+G and placebo arms. DFS was 27.2% (placebo), 55.4% (TLPLDC), 22.9% (TLPLDC+G), and 60.9% (TLPO) (p<0.001). OS was 62.5% (placebo), 93.6% (TLPLDC), 57.7% (TLPLDC+G), and 94.6% (TLPO) (p=0.002).ConclusionsThe TLPO and TLPLDC (without G-CSF) vaccines were associated with improved DFS and OS in this clinical trial. Given production and manufacturing advantages, the efficacy of the TLPO vaccine will be confirmed in a phase 3 trial.Trial registration numberNCT02301611.
Genetic Determinants of the Association between Osteoarthritis and Psychiatric Disorders
Authors: Chen Wenwen , Zhu Jianwei , Han Xin , Zeng Yu , Hou Can , Qu Yuanyuan , Yang Huazhen , Hu Yao , Sun Yajing , Song Huan 
Published: August 2023

Background. The associations between hip/knee osteoarthritis (OA) and various psychiatry disorders, as well as the underlying genetic determinants, remain unclear. Methods. Based on the community-based prospective data of UK Biobank, we constructed two matched cohorts to assess the bidirectional associations between OA and five common psychiatry disorders. Then, we further examined the existence of overall genetic association for those disease pairs with demonstrated phenotypic association through polygenic risk score (PRS) prediction using individual-level genotyping data of UK Biobank and LD score regression (LDSC) analysis utilizing publicly available GWAS summary statistics. Last, also based on GWAS summary statistics, we performed enrichment analyses to pinpoint specific genetic determinants that might contribute to the observed overall genetic shares. Results. The phenotypic analyses revealed an elevated risk of hip/knee OA among individuals with any psychiatric disorders, compared to their matched unexposed individuals (hazard

ratio

HR

=
1.62

, 95% confidence interval (CI): 1.57-1.68), and vice versa (HR =1.93, 95% CI: 1.83-2.04). We further observed positive associations of knee OA with depression and stress-related disorder in the PRS analyses, which corroborated with the results of LDSC analyses (

r

for

genetic
=
0.20

(95% CI: 0.15-0.25) and

r

for

genetic
=
0.29

(95% CI: 0.19-0.40), respectively). Using GWAS summary statistics, we identified several shared genes and pathways, particularly the biological process related to HDAC histones, between knee OA and depression/stress-related disorder. Conclusions. Our study demonstrated a bidirectional association between OA and multiple psychiatric disorders, and the findings of shared genetic architectures between knee OA and depression/stress-related disorder provided possible targets for further mechanistic exploration and intervention development.
A Survey of Cancer Risk Behaviors, Beliefs, and Social Drivers of Health in New Hampshire and Vermont
Authors: Skipper Thomas A. , Weiss Julie E. , Carlos Heather A. , Gunn Christine M. , Hasson Rian M. , Peacock Janet L. , Schiffelbein Jenna E. , Tosteson Anna N.A. , Lansigan Frederick , Rees Judy R. 
Published: August 2023

Compared with urban areas, rural areas have higher cancer mortality and have experienced substantially smaller declines in cancer incidence in recent years. In a New Hampshire (NH) and Vermont (VT) survey, we explored the roles of rurality and educational attainment on cancer risk behaviors, beliefs, and other social drivers of health. In February–March 2022, two survey panels in NH and VT were sent an online questionnaire. Responses were analyzed by rurality and educational attainment. Respondents (N = 1,717, 22%) mostly lived in rural areas (55%); 45% of rural and 25% of urban residents had high school education or less and this difference was statistically significant. After adjustment for rurality, lower educational attainment was associated with smoking, difficulty paying for basic necessities, greater financial difficulty during the COVID-19 pandemic, struggling to pay for gas (P &lt; 0.01), fatalistic attitudes toward cancer prevention, and susceptibility to information overload about cancer prevention. Among the 33% of respondents who delayed getting medical care in the past year, this was more often due to lack of transportation in those with lower educational attainment (21% vs. 3%, P = 0.02 adjusted for rurality) and more often due to concerns about catching COVID-19 among urban than rural residents (52% vs. 21%; P &lt; 0.001 adjusted for education). In conclusion, in NH/VT, smoking, financial hardship, and beliefs about cancer prevention are independently associated with lower educational attainment but not rural residence. These findings have implications for the design of interventions to address cancer risk in rural areas.

Significance:
In NH and VT, the finding that some associations between cancer risk factors and rural residence are more closely tied to educational attainment than rurality suggest that the design of interventions to address cancer risk should take educational attainment into account.
The Twin Challenges Facing Myanmar and How the World Can Help
Authors: Marciel Scot 
Published: August 2023

Abstract
The Myanmar resistance’s urgent task is to push the hated, brutal military out of political power once and for all. Just as importantly, however, it simultaneously needs to create the best possible conditions for any future democratic government to succeed. This goal will require addressing a wide range of difficult issues that either have lingered unresolved for many years or that have grown out of the post-2021 coup and subsequent conflict. These include restructuring the security forces, developing and implementing a system of federalism, building rule of law, tackling long-standing identity issues, and rebuilding and reinvigorating the economy. It will also need to establish an interim governance structure and decide how to maintain security and basic governance during the inevitable transition period. The international community should step up efforts to help the resistance achieve both of these goals, including by increasing aid, training and scholarships and establishing a “Friends of Myanmar Democracy Group” to coordinate approaches.
The Role of Ethnic Minorities in the Resistance Movement
Authors: Young Elijah 
Published: August 2023

Abstract
This article explores the role of some prominent ethnic minority armies in the course of resistance to the coup. It selectively describes how some ethnic minorities such as Karen, Kachin, Karenni, Chin, Rakhine, Wa, and Shan play leadership role in the resistance movement before and after the 2021 military coup. It emphasizes the ongoing movement of how the 2021 coup created a window of opportunity for the interreligious collaboration between such ethnic minority groups and ethnic majority Bamar groups. It then shows how their interethnic collaboration blocked coup makers from consolidating their powers. The article also highlights how some ethnic minority Christian leaders, pastors, lay Christians, nuns, and priests witness their prophetic and apostolic faith in various ways of hidden and public resistance.
“Tú sabes lo que le pasa a él?”: the Role of (Relational) Epistemics in Indirect Complaint Sequences in Spanish and English Family Talk
Authors: Rodriguez Andrea , Sinkeviciute Valeria 
Published: August 2023

Abstract
Drawing on interactional pragmatics and membership categorisation analysis, this paper explores indirect (third-party-oriented and situation-oriented) complaints in Spanish and English interactions between family members where expectations of affiliation are contingent on (relational) epistemic (im)balances. We analyse how (1) disaffiliation is constructed through the recipient’s more knowledgeable position in relation to the matter at hand, (2) complainability is legitimised when the recipient lacks epistemic access to the issue and (3) complaints are partially disattended by the recipient due to their inferior epistemic status regarding the situation. Throughout, we argue that (relational) epistemics is a necessary feature to incorporate in analysis, when it concerns the recipient’s responses and, therefore, interpersonal achievement of social actions. We show how complainants treat the prior turns as relevant to the rights, obligations and expectations related to their relational categories and how extended sequences of complaints are co-constructed and negotiated in interaction.
Restrictive versus liberal fluid administration strategy (REFILL study) in postpartum hemorrhage and its effects on thromboelastometry (ROTEM®) values: a randomized, controlled trial
Authors: Schol Pim B.B. , Lange Natascha de , Henskens Yvonne , Smits Luc J.M. , Smeets Nicol A.C. , Scheepers Hubertina C.J. 
Published: August 2023

Objective Current obstetric guidelines for postpartum hemorrhage (PPH) vary in fluid resuscitation management. This study aimed to evaluate the effect of fluid management on coagulation parameters in early PPH. Methods We performed a multicenter, randomized trial. Women who had 500 mL of blood loss in the third stage of labor were randomized to receive a restrictive fluid administration strategy or a liberal fluid administration strategy. A rotational thromboelastometry panel was performed in 72 patients. We evaluated within-group and between-group differences in the EXTEM clotting time (CT), EXTEM amplitude at 10 minutes (A10), INTEM CT, and FIBTEM A10. We also evaluated the mean fibrinogen concentration, activated partial thromboplastin time, and partial thromboplastin time in the total study population (n = 249). Results There were no significant differences in hemostatic parameters between the groups after correction for baseline values. Conclusions In women with PPH <1500 mL, there is no clinically relevant effect of a restrictive or liberal fluid administration strategy on thromboelastometric hemostatic and regular coagulation parameters.
Use of canakinumab and remdesivir in moderate-severe COVID-19 patients: A retrospective analysis
Authors: Mastroianni Antonio , Vangeli Valeria , Chidichimo Luciana , Urso Filippo , De Marco Giuseppe , Zanolini Alfredo , Greco Francesca , Mauro Maria V , Greco Sonia 
Published: August 2023

Objectives: The dysregulated immune response occurring upon COVID-19 infection can lead to tissue damage and organ failure. Different therapeutic strategies are needed to cope with the current and future outspread of COVID-19, including antiviral and anti-inflammatory agents. We describe the outcome of hospitalized patients treated with canakinumab and remdesivir plus the standard of care therapy. Methods: This observational study describes the outcome of the combination of canakinumab (450 mg for patients ≥40 and <60 kg, 600 mg for those ≥60 and <80 kg, or 750 mg for patients ≥80 kg) and 200 mg remdesivir intravenous infusion, plus standard of care (SOC), in 17 moderate-to-severe COVID-19 patients hospitalized in the “Annunziata” Hospital, Cosenza, Italy, between August and November 2021. Hematological markers, biochemical, and hemogasanalysis values at baseline versus day 7 of combination treatment were compared by paired t test after checking for normal distribution and correcting for multiple comparison. Results: The median age of patients was 64 years (range: 39–85), and the median hospitalization time (calculated on the 16 patients that were not transferred to intensive care unit) was of 12.5 days (range: 7–35 days); 15/17 patients (88%) did not experience complications. After 7 days of combination therapy, all the inflammatory parameters were significantly reduced with the exception of procalcitonin; moreover, hematological prognostic markers such neutrophil-to-lymphocyte ratio, CRP-to-lymphocyte ratio, and derived neutrophil-to-lymphocyte ratio reduced. Overall, 16/17 patients (94%) recovered after 14 days. Conclusions: Canakinumab and remdesivir treatment, in addition to SOC, in the early stage of moderate-to-severe COVID-19 showed promising outcomes in terms of safety and effectiveness potentially leading to a reduction in inflammatory and hematological prognostic markers after 7 days of treatment.
The IRF6 rs2013162 and MTHFR A1298C rs1801131 Gene Polymorphisms Related to non-Syndromic Cleft lip and Palate among Deutero-Malay in Indonesia
Authors: Nasroen Saskia L. , Tammama Tichvy , Darwis Rudi S. , Adil Almira , Rahmutia Silvia , Maskoen Ani Melani , Gani Basri A. 
Published: August 2023

Objective This study aimed to identify risk factors for NSCLP by analyzing polymorphisms in IRF6 rs2013162 and MTHFR A1298C rs1801131 in the Deutero Malay Population in Indonesia. Setting DNA isolation from venous blood samples was done followed by PCR and PCR-RFLPs method. Patients/Participants 115 NSCLP subjects and 120 healthy control subjects. Main Outcome Measure(s) The odds ratio (OR) determined to evaluate the risk factors is the main outcome measure. Material and Methods The study is a case-control design using samples from the venous blood of 115 NSCLP subjects and 120 healthy control subjects. After DNA was extracted, the PCR-RFLPs method was performed using the DdeI restriction enzyme on 100 blood samples of the IRF6 rs2013162 group and Mboll restriction enzyme on 135 blood samples of the MTHFR A1298C rs1801131 group. The Chi-Square test was used with the Exact Fisher alternatives, depending on the expected count value. Results The results showed that the T mutant allele (OR = 4.125, P < .05) and GT genotype (OR = 21.00, P < .05) of IRF6 rs2013162 and the C mutant allele (OR = 3.781, P < .05), AC genotype (OR = 5, P < .05) and CC genotype (OR = 9,681, P < .05) of the MTHFR A1298C is associated to a greater risk of NSCLP. Conclusions IRF6 rs2013162 and MTHFR A1298C rs1801131 gene polymorphisms are strongly associated with NSCLP among the Deutero Malay population in the Indonesian population.
The use of telephone and video consultations in upper limb musculoskeletal rehabilitation: A scoping review
Authors: Maltby Amy , Underhill Ann , Woodbridge Sarah 
Published: August 2023

Introduction In 2020, the COVID-19 pandemic caused a rapid uptake of virtual consultations (VCs) to minimise disease transmission and for this reason, research into telerehabilitation has been expanding. This review aimed to map and synthesize evidence on the use of VCs in upper limb musculoskeletal rehabilitation, describe key characteristics, and identify gaps in the research. Methods This scoping review investigated synchronous rehabilitation consultations performed over VC. All asynchronous, wearable or pre-recorded technology was excluded. CINAHL Complete, Medline, PEDro, Google Scholar and grey literature sources were searched. Screening and data extraction were done by a single researcher. Frequency counts were used to analyse the data. Results Nineteen studies were identified, with patients with shoulder injury/pain most frequently studied. Most sources (n = 9) used bespoke video programmes. Range of motion (ROM) was the most common assessment (n = 10) and exercise prescription (n = 7) was the most common treatment. Benefits included time and cost savings, maintaining therapeutic relationships and increasing patient independence. Most diagnostic assessments, except joint and nerve tension tests, were found to be reliable and valid. Studies noted increased function in activities, decreased pain and increased ROM after VCs. Limitations included restricted ‘hands-on’ treatment, resource and training concerns and limiting patient factors. Conclusions This review mapped available evidence and identified several gaps in the literature. Further robust research into VCs for hand/wrist disorders, ROM assessment and cost-effectiveness is needed.
Associations of physical activity and quality of life in parapneumonic effusion patients
Authors: Lopez Pedro , Fitzgerald Deirdre B. , McVeigh Joanne A. , Badiei Arash , Muruganandan Sanjeevan , Newton Robert U. , Straker Leon , Lee Yun Chor Gary , Peddle-McIntyre Carolyn J. 
Published: August 2023

IntroductionLittle is known about activity behaviours and quality of life (QoL) of patients with parapneumonic pleural effusions (PPE) after hospital discharge. This study is a secondary analysis of a randomised trial (dexamethasoneversusplacebo) for hospitalised patients with PPE. We: 1) described the patients’ activity behaviour patterns and QoL measured at discharge and at 30 days post-discharge; and 2) examined the association between activity behaviours and QoL scores.MethodsActivity behaviour (7-day accelerometry; Actigraph GT3X+) and QoL (Medical Outcomes Study Short-Form 36) were assessed. Repeated measures analysis of covariance controlling for baseline values and a series of linear regression models were undertaken.Results36 out of 53 eligible participants completed accelerometry assessments. Despite modest increases in light physical activity (+7.5%) and some domains of QoL (>2 points) from discharge to 30 days post-discharge, patients had persistently high levels of sedentary behaviour (>65% of waking wear time) and poor QoL (≤50 out of 100 points) irrespective of treatment group (p=0.135–0.903). Increasing moderate-to-vigorous physical activity was associated with higher scores on most QoL domains (p=0.006–0.037). Linear regression indicates that a clinically important difference of 5 points in physical composite QoL score can be achieved by reallocating 16.1 min·day−1of sedentary time to moderate-to-vigorous physical activity.ConclusionPatients with PPE had low levels of physical activity and QoL at discharge and 30 days post-discharge irrespective of treatment. Moderate-to-vigorous physical activity participation was associated with higher QoL scores. Increasing moderate-to-vigorous physical activity following discharge from the hospital may be associated with improvements in QoL.
Amoxicillin and cefixime simultaneous adsorption by facile synthesized chitosan@polyacrylamide@ZIF-8: isotherm and kinetic study
Authors: Zadvarzi Saber Babaee , Amooey Ali Akbar 
Published: August 2023

AbstractIn recent years, taking medicine has been increasing around the world due to population growth and the spread of disease. Antibiotics as a kind of these medicines include about 10 to 15% of drug consumption. Studies show that antibiotics, which are not completely removed, have a permanent and destructive effect on the environment. In this study, the chitosan@polyacrylamide@ZIF-8 as an adsorbent was simultaneously used to remove cefixime and amoxicillin from the aqueous solution by adsorption methods. XRD and FTIR patterns were analyzed to investigate the surface crystallinity and the chemical properties of the adsorbent. In the following, SEM and TEM images were used for surface morphology study. Finally, a numerical investigation was done for predicting the adsorption effective parameters. The results show that pH 4, contact time 30 min, initial concentration 50 mg/L, temperature 25 °C and 15 mg of adsorbent in 10 mL of polluted water are optimal conditions at which a removal percentage of up to 90% was achieved. The Langmuir, Freundlich, Temkin, and Dubinin–Radushkevich isotherms were examined by experimental data and Langmuir model presented the best consistency with the experimental results and the maximum calculated adsorption capacity for amoxicillin and cefixime are 910 mg/g and 588 mg/g, respectively. Pseudo-first order, pseudo-second order and intraparticle diffusion were investigated for kinetic studies. The results of the calculations illustrated the pseudo-second order model has been dominant. Overall, this study expresses, chitosan@polyacrylamide coated by ZIF-8 can be used an appropriate, effective, and economical adsorbent for the adsorption of amoxicillin and cefixime.
Graphical Abstract