bluuebunny/crossref_metadata_2025_split huggingface dataset:
Randomized phase II study of nalicap (nal-IRI/capecitabine) compared to NAPOLI (nal-IRI/5-FU/LV) in gemcitabine-pretreated advanced pancreatic cancer: Trial-in-progress.
Authors: Oh Do-Youn , Kim Jin Won , Lee Myung Ah , Kim Ilhwan , Lee Choong-kun , Seol Young Mi , Yoo Changhoon , Oh Sang Cheul , Bae Woo Kyun , Chon Hongjae , Choi In Sil , Yoon Jeesun , Park Joon Oh 
Published: January 2022

TPS621 Background: Liposomal irinotecan (nal-IRI) in combination with fluorouracil (5-FU) and folinic acid (LV), called the NAPOLI regimen, improves survival in advanced pancreatic cancer patients who failed gemcitabine-based chemotherapy (Wang-Gillam A et al. 2016). Capecitabine is an oral anti-cancer agent as the prodrug of 5-FU. Capecitabine has proven its efficacy in gastrointestinal cancers like stomach cancer, colon cancer, or pancreatic cancer. Replacing continuous 5-FU infusions with oral capecitabine with equivalent efficacy has been tested and is now widely used. However, in pancreatic cancer, replacing continuous infusion of 5-FU with an oral drug has not yet been tested. Therefore, this trial is being conducted with the aim of improving patient convenience while maintaining efficacy, when the continuous infusion of 5-FU/LV in NAPOLI (nal-IRI/5-FU/LV) regimen are replaced with oral capecitabine. This study is a two-arm, open-label, multicenter, randomized phase 2 trial to assess whether capecitabine plus nal-IRI combination treatment (NaliCap) is non-inferior to NAPOLI regimen in gemcitabine-pretreated patients with advanced pancreatic cancer. Methods: Eligible patients have histologically confirmed pancreatic adenocarcinoma who have failed to gemcitabine-based chemotherapy. This trial is composed of two parts: safety lead-in-part and randomization part. NaliCap regimen consists of administration of capecitabine twice daily for day 1-14 and intravenous administration of nal-IRI for day 1 every 3weeks. To figure out recommended phase 2 dose of the NaliCap combination regimen, the safety lead-in-part is being conducted as a 3+3 design. In the randomization part, patients will be assigned to NAPOLI or NaliCap in a 1:1 ratio. The planned enrollment is 184 patients in the randomization part. Patients allocated to the NaliCap group will receive recommended phase 2 dose of NaliCap determined through the safety lead-in-part. Patients allocated with the NAPOLI group will receive nal-IRI 70mg/m2 intravenously day 1, LV 400mg/m2 IV day 1, and continuous 5-FU 2400mg/m2 infusion over 48hours every 2weeks. Response assessments are performed every 6 weeks using the RECIST criteria version 1.1 (every 2 cycles in the NaliCap group and every 3 cycles in the NAPOLI group). The primary endpoint is progression-free survival, with a non-inferior margin of the hazard ratio of 1.4. Key secondary endpoints are overall response rate, disease control rate, overall survival, safety, and quality of life. This study is prospectively registered at ClinicalTrials.gov, NCT04371224. Clinical trial information: NCT04371224.
An open, single-center, exploratory clinical trial to evaluate the safety and efficacy of RNA CAR-mesothelin T cells in patients with advanced refractory pancreatic cancer.
Authors: Yang Hui , Guo Liting , Zhou Chenfei , Liu Xiaojun , Zhao Yangbing , Zhang Jun , Shi Yan 
Published: January 2022

TPS628 Background: Pancreatic cancer is an aggressive gastrointestinal cancer characterized by late diagnosis initially, prone to distant metastasis and poor prognosis. The current treatment of pancreatic cancer is very limited, resulting in its 5-year survival rate of less than 10%. It is necessary to seek new treatment methods and treatments. Chimeric antigen receptor T (CART) cell therapy has made a breakthrough in hematological malignancies. Therefore, the goal of this clinical trial is to study the safety, efficacy and pharmacokinetics of mRNA-engineered anti-Mesothelin Chimeric Antigen Receptor T-Cell (anti-MESO CAR-T cells) therapy in patients with mesothelin expression-positive, advanced pancreatic tumors that have failed at least first-line or second-line therapy. Methods: The study will adopt the "3+3" dose escalation design exploring two doses of 1×109 and 3×109. The administration is planned to infuse 3 times a week for 2 consecutive weeks. The subjects will receive a total dose of 1x109 RNA transduced anti-MESO CAR-T cells in the first week, following lymphodepleting chemotherapy with cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day given over 3 days by intravenous infusion. If there is no obvious dose-limiting toxicity (DLT) after the first week of infusion, three times consecutive infusions of 1x109 anti-MESO CAR-T cells each time is planned in the second week. Each subject needs to be observed for at least 2 weeks (14 days) after completing the last infusion. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of anti-MESO CAR-T cells. Clinical trial information: 04981691.
A phase I study to evaluate the safety and tolerability of SX-682 in combination with PD-1 inhibitor as maintenance therapy for unresectable pancreatic adenocarcinoma.
Authors: Dunne Richard Francis , Ullman Nicholas A. , Belt Brian A. , Ruffolo Luis I. , Burchard Paul , Hezel Aram F , Zittel Jason , Wang Wenjia , Ramsdale Erika E. , Kaul Vivek , Zebala John , Linehan David 
Published: January 2022

TPS631 Background: Survival outcomes for advanced pancreatic ductal adenocarcinoma (PDAC) remain dismal despite improvements in systemic therapy regimens developed over the past decade. In addition, current first-line therapies result in cumulative cytopenias and neuropathy, highlighting the need for more effective, less toxic maintenance treatment strategies. There are currently no standard approved maintenance treatments for patients with PDAC not associated with BRCA or DNA-repair mutations. Pre-clinical data suggest a potential synergistic effect of combining blockade of CXC chemokine receptors (CXCR) with immunotherapy or chemotherapy in pancreatic cancer1,2. We are currently conducting a Phase I study (NCT04477343) evaluating SX-682, an oral CXCR1/2 inhibitor, and Nivolumab as maintenance treatment for advanced PDAC. Methods: This is an open-label, dose escalation Phase I clinical trial evaluating the combination of SX-682 and Nivolumab. Patients must have histologically confirmed unresectable PDAC and have completed at least 16 weeks of first-line chemotherapy with disease stability or treatment response at time of enrollment. Radiographically measurable disease must be present per iRECIST criteria. Patients receive a 3-week run-in phase of twice-daily dosing of SX-682, followed by combination of twice-daily dosed SX-682 and every 2-week Nivolumab (240 mg IV). Dose finding of SX-682 is performed using Bayesian optimal interval (BOIN) design to determine the maximum tolerated dose (MTD) when combined with Nivolumab. Pre-treatment and one on treatment (Day 28-35) biopsies are required for enrollment to evaluate change in tumor microenvironment immune cell composition by single cell-RNA sequencing, flow cytometry, RNA RT-qPCR, and IHC. The primary endpoint is to determine MTD; the key secondary endpoint is progression-free survival (PFS), defined as the time from enrollment to progression via iRECIST criteria or death. Nine of a planned 20 patients have been enrolled. Dose-level 1 (SX-682 50 mg BID) completed enrollment without dose-limiting toxicity (DLT). Dose-level 2, which commenced in June 2021, (SX-682 100 mg BID) is without DLTs, but has not completed enrollment at time of abstract submission. Nywening TM, Belt BA, Cullinan DR, et al. Targeting both tumour-associated CXCR2(+) neutrophils and CCR2(+) macrophages disrupts myeloid recruitment and improves chemotherapeutic responses in pancreatic ductal adenocarcinoma. 1) Gut. 2018;67(6):1112-1123. Steele CW, Karim SA, Leach JDG, et al. CXCR2 Inhibition Profoundly Suppresses Metastases and Augments Immunotherapy in Pancreatic Ductal Adenocarcinoma. 2) Cancer Cell. 2016;29(6):832-845. Clinical trial information: NCT04477343.
Biomarker-oriented study of pembrolizumab in combination with chemotherapy in chemotherapy-naïve advanced pancreatic cancer: A phase 2 trial-in-progress.
Authors: Yoon Jeesun , Kim Jin Won , Kim Ji-Won , Kim Tae-Yong , Nam Ah-Rong , Bang Ju-Hee , Kim Jae-Min , Oh Kyoung Seok , Oh Do-Youn 
Published: January 2022

TPS639 Background: Pancreatic cancer (PC) is well-known as a strongly immunosuppressive tumor. The tumor microenvironment of PC play a fundamental part in maintaining a non-immunogenic and immuno-suppressive environment through the production of inhibitory cytokines and complex interaction between tumor cells, regulatory T cells, and myeloid-derived suppressor cells (Li KY et al. 2020). However, through integrated genomics and immunophenotyping, the immune-rich type had a relatively good prognosis in advanced PC (Wartenberg M et al. 2018). Based on this, various attempts have been made to apply immune checkpoint inhibitor (ICI) to PC. Disappointingly, ICI monotherapy is ineffective in most advanced PCs, and a strategy of combining ICI with ICI, chemotherapy or targeted therapy has been recently tried. However, the mechanism of immune modulation induced by ICI in combination with chemotherapy in PC is still not well-known, so biomarker studies are needed to understand the role of immunotherapy in advanced PC. Also based on this, it is expected to develop an effective ICI treatment strategy in PC. This study is a non-randomized, parallel assignment phase 2 trial aimed to explore dynamic modulation of the immune system caused by co-administration of pembrolizumab and cytotoxic chemotherapy in patients with advanced PC. Methods: Eligible patients have recurred or metastatic pancreatic cancer. Patients who have received chemotherapy for advanced PC are excluded, except for previous adjuvant chemotherapy. Patients who have received ICI are excluded. There are 2 chemotherapy cohorts (FOLFIRINOX, n=41; Gemcitabine/Nab-paclitaxel, n=36). Patients enrolled in the FOLFIRINOX cohort will receive pembrolizumab 200mg intravenously once every 3 weeks, plus FOLFIRINOX chemotherapy every 2 weeks. In Gemcitabine/Nab-paclitaxel cohort, patients will receive gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 day 1, 8, 15 of a 4-week cycle, plus pembrolizumab 200mg intravenously once every 3 weeks. The primary endpoint is objective response rate, with key secondary endpoints including progression-free survival, duration of response, disease control rate, overall survival, safety, and patient-reported outcome. For evaluating metabolic response, 18F-FDG PET-CT scan will be conducted before treatment and at the first response evaluation. Tumor tissue biopsies are performed three times in total: screening, the first response evaluation, and disease progression. Blood samples are being collected every cycles for translational biomarker studies. Clinical trial information: NCT04447092.
Generic anisotropic Lifshitz scalar field theory: New massive minimal subtraction
Authors: Leite Marcelo M. 
Published: January 2022

Abstract
We formulate the simplest minimal subtraction version for massive

scalar fields with O(N) symmetry for generic anisotropic Lifshitz spacetimes. We introduce the simplest geometric concepts to define it as a special manifold. Then we restrict ourselves to flat Euclidean spaces. An appropriate partial-p operation is applied in the bare two-point vertex function diagrams, which separates the original diagram into a sum of two different integrals which are the coefficients of the corresponding polynomials in the mass and external momentum. Within the proposed method, the coefficient of the mass terms can be discarded and we obtain a minimal subtraction method almost identical to the same scheme in the massless theory in every external momentum/mass subspace. We restrict our demonstration of the method up to three-loop order in the two-point vertex part. We verify its consistency through a diagrammatic computation of static critical exponents, which validates the universality hypothesis.
Comparisons of the effects of solute interactions on partition coefficient, kD, in selected binary immiscible solvents: a case of oxalic acid and succinic acid
Authors: V. O. Onyeocha , A. I. Onuchukwu , R. E. Enemo 
Published: January 2022

Background: The molecular distributions of solutes in binary immiscible solvents as used in partition coefficient technique serve as measures of the solute separation, concentration and beneficiation from contaminants. Methods: The effects of solute interactions on partition coefficient, kD, in selected binary immiscible solvents were investigated at 300C and atmospheric pressure. The activities from the interactions with changes of concentrations within the solvents were analysed. These were done using simple titration method. The solutes were distributed in the binary solvents and the concentrations from the two layers formed were determined by titration method. The interactions of oxalic acid and succinic acid in carbon tetrachloride-water, diethyl ether-water, and n-hexane-water were studied for the partition coefficient values in the respective systems, to determine the nature and degree of the interfering reactions that are affecting the distributions, and to ascertain the best binary solvents from the three systems. Results: Oxalic acid has the partition coefficient of 0.0738 in carbon tetrachloride-water with the dimerization constant of -15.7092 and ionization constant of 0.0303. Oxalic acid has the distribution coefficient of 0.0173, dimerization constant of 144.0167 and the ionization constant of 0.0035 in diethyl ether-water. Oxalic acid has the partition coefficient of 0.0279, dimerization constant of 20.2798 and ionization constant of 0.0019 in n-hexane-water. Succinic acid has the partition coefficient of -0.05617, dimerization constant of -18.5655 and ionization constant of 0.0284 in carbon tetrachloride-water. In diethyl ether-water, succinic acid has the partition coefficient of 0.0427, dimerization constant of -18.1611 and ionization constant of 0.0332. In n-hexane-water, succinic acid has the partition coefficient of -0.04274, dimerization constant of 71.9491 and ionization constant of 0.0265. Conclusion: From these results, carbon tetrachloride-water is recommended for the purification and extraction of oxalic acid from contaminants. Carbon tetrachloride-water is also the best binary immiscible solvent for succinic acid.
The effect of dietary fat supplements on the activity of palmitic and stearic acid desaturases based on the results of a study of the fatty acid composition of neutral lipids in blood serum and liver of rats receiving a fat-free diet
Authors: Levitsky A. , Gozhenko A. , Velichko V. , Selivanskaya I. 
Published: January 2022

Background. Desaturase enzymes are involved in the formation of monoenoic acids from saturated fatty acids. One such enzyme is stearyl-CoA-desaturase (SCD1), which converts stearic acid to oleic acid. The aim of this work was to determine the effect of edible fats with different fatty acid compositions on SCD1 activity.
Methods. High linoleic sunflower oil (HLSO), high oleic sunflower oil (HOSO) and palm oil (PO) were used. The rats were fed for 30 days with a semi-synthetic diet that did not contain any fats (FFD) and fat diets containing 5 % of each of the above oils. In animals, lipids were extracted from serum and liver and divided into 3 fractions: neutral lipids (NL), phospholipids (PL), and free fatty acids (FFA).
The fatty acid composition of each fraction was determined by gas chromatography. The SCD18 activity was determined by the C18:1 n-9/C18:0 ‒ ratio, and the SCD16 activity was determined by the C16:1 n-7/C16:0 ratio.
Results. A higher activity of SCD16 and SCD18 was found in the NL fraction, and the activity of SCD18 significantly exceeds that of SCD16. A decrease in the content of C16:0, C16:1 and C18:0 in the NL fraction of the liver and blood serum was shown. The activity of SCD16 in blood serum and liver decreases in rats fed fat diets­, while the activity of SCD18 does not decrease, and even increases with the consumption of HOSO.­
Conclusions. To determine the SCD1 activity, it is advisable to use the C18:1/C18:0 ratio in terms of the level of fatty acids in the NL fraction. Fatty diet inhibits SCD16 activity, and consumption of HOSO increases SCD18 activity.
La influencia de Instagram en la creación y reproducción del ideal de belleza femenino
Authors: Martín Teresa , Chaves Vázquez Beatriz 
Published: January 2022

Las redes sociales hacen gala de una gran presencia en la sociedad contemporánea, afectando incluso cómo percibimos los cánones de belleza. Este trabajo estudia la posible influencia del fenómeno de los influencer en la reproducción del ideal de belleza femenino, analizando los contenidos publicados en Instagram por algunas de estas figuras públicas e indagando en el tipo de uso que hacen las personas anónimas de esta red social. Para ello, se ha recurrido a una metodología mixta compuesta por un análisis de contenido cualitativo de las publicaciones y una encuesta en línea (n= 509). La presente investigación ha permitido comprobar, entre otros aspectos, cuál es el patrón de belleza que impera en Instagram y las posibles evoluciones sobre el canon de belleza “tradicional”, dictaminando si existen implicaciones de género en dichos estereotipos.
Dental Implants for the General Dental Practitioner. Part 2: Complications, Management and Maintenance
Authors: Jones Oliver , Hoyle Philippa , Patel Rajesh 
Published: January 2022

With dental implants becoming a more common treatment option for the replacement of missing teeth, and with survival rates upwards of 90% after 10 years, it is likely that primary care dentists and dental care professionals will encounter patients presenting with problems. The second article in this two-article series outlines common biological and mechanical complications arising with dental implants and their component parts, and how to manage them.CPD/Clinical Relevance: This article highlights important aspects the primary care practitioner should consider when examining and maintaining dental implants, and provides an overview of common biological and mechanical complications associated with implant-retained restorations.
The Numb Lip: Non-Small Cell Lung Cancer First Presenting in the Head and Neck
Authors: Daldry Michael , Lloyd Timothy Edwin , Stewart Grant 
Published: January 2022

Diagnosing the cause of paraesthesia can be challenging. A patient with an unremarkable medical history, non-smoker and no known allergies, presented with paraesthesia in the distribution of the mental nerve with no obvious dento-alveolar pathology. After further investigations the patient was found to have multiple brain metastases and a solitary mandibular deposit, with the primary site being an adenocarcinoma of the lung. CPD/Clinical Relevance: As dental professionals, knowledge of head and neck manifestations of systemic conditions is required if prompt diagnosis and treatment is to occur, which will subsequently improve patient health outcomes.
Efficiency of Invisalign in contemporary orthodontic practice
Authors: Elhussein Mustafa , Sandler Cara , Sandler Jonathan 
Published: January 2022

The demand for clear aligners continues to grow. Their use is no longer exclusive to adults, because aligners are also now popular among younger patients as well. In the literature, there is an emphasis on cases of mild to moderate severity, which have usually been treated on a non-extraction basis, perhaps owing to the difficulty in managing space closure or a challenging tooth movement, such as derotation. The article highlights appropriate case selection in clinical orthodontic practice, and the key role that Invisalign plays. CPD/Clinical Relevance: The reader should appreciate the potential of the Invisalign system in managing certain scenarios commonly encountered in clinical orthodontics practice.
Experiments and Performance Evaluation of a New Wheat Seed Shooting Device for the North China Plain
Authors: Wang Yingbo , Li Hongwen , He Jin , Wang Qingjie , Lu Caiyun , Liu Peng , Yang Qinglu , Wang Chunlei , He Dong 
Published: January 2022

HighlightsA noncontact mechanical wheat seed shooting device was developed for use in the North China Plain.The shooting depth increased with increasing shooting velocity and with increasing shooting angle.The tested parameters were statistically significant for average shooting depth (ASD), coefficient of variation of shooting depth (CVSD), and coefficient of variation of seeding amount (CVSA).The results from bench and field experiments indicated that the performance of the shooting device with the optimized parameters could fully meet the planting requirements for winter wheat in the North China Plain.Abstract. Planting performance is essential for wheat planters and seed emergence. In this study, a noncontact mechanical wheat seed shooting device was developed to simplify the planter structure, eliminate blockage of the soil-contacting parts, and enhance the stability of the sowing depth. A preliminary model of shooting wheat was developed using DEM software to simulate the shooting depth. The modeling results showed general trends of increased shooting depth with increasing shooting velocity and shooting angle, and decreased shooting depth with increasing shooting height. The shooting depth exceeded 30 mm when the shooting velocity of the wheat seeds was greater than 30 m s-1 and the shooting height was less than 150 mm. Additionally, to increase the stability of the sowing depth, this study investigated the effects of three operating parameters (forward speed, rotational speed of the shooting device, and shooting height) on the average shooting depth (ASD), shooting velocity of seed (SVS), coefficient of variation of shooting depth (CVSD), and coefficient of variation of seeding amount (CVSA). The SVS was proposed as an indicator of shooting performance. A three-factor central-composite experiment was performed to understand the parameter interactions and verify the optimal parameter values. The results from bench and field experiments demonstrated that the performance of the shooting device with the optimized parameters could fully meet the sowing requirements for winter wheat in the North China Plain. The ASD, CVSD, CVSA, and SVS of the seed shooting device with the optimized parameters were 34.6 mm, 9.3%, 13.9%, and 35.8 m s-1, respectively. The seed damage rate (SDR), seed germination rate (SGR), and coefficient of variation of seeding uniformity (CVSU) in the field experiment were 0.9%, 88.2%, and 13.5%, respectively. Keywords: Coefficient of variation of shooting depth, Shooting device, Shooting velocity, Winter wheat.