bluuebunny/crossref_metadata_2025_split huggingface dataset:
Role of diffusion-weighted magnetic resonance imaging in detection of lymph node metastasis in rectal cancer
Authors: shimy Rehab Mohamed , Aly Asmaa Monir , Elshishtawy Samer Ali , Hassan Mona H. , Desouky Shimaa H. I. , Hanna Amir 
Published: August 2024

Abstract
Background
Rectal cancer is the most prevalent gastrointestinal tumor. Early diagnosis, accurate staging as well as early treatment are the keys for improving the five-year survival rate. The objective of this research is to assess the effectiveness of diffusion-weighted MRI (DWI) in identifying lymph nodes and distinguishing between benign and metastatic nodes throughout the first stage of primary rectal cancer.

Results
The study showed that mean ADC value was significantly higher in mucinous carcinoma (1.72 ± 0.36 × 10–3 mm2/sec) than that in non-mucinous carcinoma (0.981 ± 0.276 × 10–3 mm2/sec) with a cutoff value of (1.3 × 10–3) mm2/s which was the precise value to produce high sensitivity, specificity and accuracy of 93%, 94%, and 94%, respectively. ADC analysis showed either intermediate or low signal in 49 (70%) and high signal in 21 (30%) L.Ns. Mean ADC value showed a significant reduction in malignant L.Ns (1.01 ± 0.54 × 10–3 mm2/sec) compared to benign L.Ns (1.51 ± 0.51 × 10–3 mm2/sec), AUC of 0.674 (P = 0.008) and a cutoff value of 0.987 × 10–3 mm2/s with sensitivity, specificity and accuracy of 44.4%, 91.2% and 67.5%, respectively. The mean L.N /tumor ratio was 1.65 ± 0.73 in benign L.Ns and 1.06 ± 0.37 in malignant L.Ns.

Conclusions
In rectal cancer, there was a significant difference between benign and malignant L.Ns regarding diffusion result, L.Ns size, shape, and margin. The study demonstrated the effectiveness of DWI in diagnosing lymph node metastasis in colorectal cancer; true diffusion restriction was significantly noted in malignant L.Ns compared to benign L.Ns. Mean ADC value showed a significant reduction in malignant L.Ns compared to benign L.Ns. L.N/tumor ratio showed a significant reduction in malignant L.Ns compared to benign L.Ns.
The role of Shigella spp. in propagating bacillary dysentery in humans and the prominence of nanotechnology in disease prevention
Authors: Hmar El Bethel Lalthavel , Paul Sujata , Sharma Hemanta Kumar 
Published: August 2024

Abstract
Background
Shigellosis, also known as bacillary dysentery, is an acute infection of the intestine. The symptoms can vary from mild watery diarrhoea to severe inflammatory bacillary dysentery, which is characterized by fever, intense abdominal cramps, and the presence of blood and mucus in the stools. While the disease typically resolves on its own, it can become life-threatening in immunocompromised individuals or in the absence of adequate medical care.

Main body of the abstract
Shigella is the primary cause of bacillary dysentery worldwide. It is comprised of four distinct species—S. dysenteriae, S. flexneri, S. boydii, and S. sonnei—each with unique genomic characteristics and disease-causing abilities. Shigella spp. have developed resistance to multiple drugs and have also adapted well to the gut environment over time. They have become well-suited to infecting the human gut epithelial cells and causing dysentery. Consequently, numerous studies have investigated the potential application of nanotechnology in the treatment of shigellosis by leveraging its capability for drug delivery and targeted therapy, thereby improving effectiveness while reducing side effects.

Short conclusion
It is crucial to maintain ongoing surveillance and develop new strategies to effectively manage this issue. In this review, we shed light on the present comprehension of distinct Shigella spp. and their potential contribution to the pathogenesis of shigellosis, along with their interaction with the gut microbiota. We also provide insight into how nanotechnology may be a major factor in preventing shigellosis in the future.
Advanced statistical approaches for predicting pain after pediatric thoracotomy: a cross-sectional study using zero-inflated and Poisson models
Authors: Vittori Alessandro , Cascella Marco , Di Gennaro Piergiacomo , Marchetti Giuliano , Francia Elisa , Mascilini Ilaria , Tarquini Riccardo , Innamorato Massimo Antonio , Petrucci Emiliano , Marinangeli Franco , Coluccia Sergio , Picardo Sergio Giuseppe 
Published: August 2024

Abstract
Background
Thoracotomy is one of the surgical procedures most burdened by chronic post-operative pain. There is poor evidence regarding the possibility that even in pediatric patients, thoracotomy can be followed by post-operative pain. The primary objective of this analysis is to identify associations with home pain therapy, pain intensity, and possible protective factors acting on chronic pain in this population.

Methods
A retrospective cross-sectional study was conducted at Ospedale Pediatrico Bambino Gesù IRCCS. The study included pediatric patients undergoing thoracotomy. For statistical analyses, a logistic model and a zero-inflated strategy were implemented to explore associations and predict factors related to home-based analgesic therapy and pain intensity.

Results
Gender and age were identified as significant factors in the assignment of home therapy, with males having over seven times the risk compared to females (OR = 7.06, 95% CI = [2.11, 29.7]). At the last measurement, pain intensity was positively associated with age and the number of pain events during the week.

Conclusions
The study highlights significant factors influencing post-thoracotomy pain management in pediatric patients. These findings underscore the importance of tailored pain management strategies that consider gender and age to improve post-operative care and outcomes in pediatric thoracotomy patients.
Advancing digital healthcare in Somalia: a review of modern technologies and their implications
Authors: Ahmed Mohamed Mustaf , Dirie Najib Isse , Mohamud Abdirahman Khalif , Elmi Abdikadir Hussein , Musa Shuaibu Saidu , Alhammadi Omar Abdulkarim Saeed , Lemma Misha Abayneh , Uwamahoro Joselyne , Bananeza Roméo , Abdullahi Yinusa , Othman Zhinya Kawa , Hamid Mohammed Raihanatu , Kasimieh Omar , Labyad Safouane , Lucero-Prisno Don Eliseo 
Published: August 2024

AbstractSomalia faces many challenges in providing adequate and accessible healthcare to its population, particularly in rural and remote areas. Lack of infrastructure, resources, and security hinders the delivery of quality health services and the prevention and control of diseases. However, modern technologies such as mobile phones, the Internet, and telemedicine offer new opportunities to digitize health care and improve health outcomes in Somalia. This paper explores the current state of healthcare in Somalia, the potential benefits, and challenges of using modern technologies to digitize healthcare, and the best practices and recommendations for implementing such technologies in the Somali context. This paper examines a telemedicine project that connects remote healthcare facilities with urban specialists. We assess its effectiveness and sustainability, showing its potential to improve healthcare in rural areas of Somalia. The review concludes that modern technologies can play a vital role in digitizing healthcare in Somalia, but they require careful planning, coordination, and evaluation to ensure their effectiveness and suitability.
Development and initial evaluation of a clinical prediction model for risk of treatment resistance in first-episode psychosis: Schizophrenia Prediction of Resistance to Treatment (SPIRIT)
Authors: Farooq Saeed , Hattle Miriam , Kingstone Tom , Ajnakina Olesya , Dazzan Paola , Demjaha Arsime , Murray Robin M. , Di Forti Marta , Jones Peter B. , Doody Gillian A. , Shiers David , Andrews Gabrielle , Milner Abbie , Nettis Maria Antonietta , Lawrence Andrew J. , van der Windt Danielle A. , Riley Richard D. 
Published: August 2024

BackgroundA clinical tool to estimate the risk of treatment-resistant schizophrenia (TRS) in people with first-episode psychosis (FEP) would inform early detection of TRS and overcome the delay of up to 5 years in starting TRS medication.AimsTo develop and evaluate a model that could predict the risk of TRS in routine clinical practice.MethodWe used data from two UK-based FEP cohorts (GAP and AESOP-10) to develop and internally validate a prognostic model that supports identification of patients at high-risk of TRS soon after FEP diagnosis. Using sociodemographic and clinical predictors, a model for predicting risk of TRS was developed based on penalised logistic regression, with missing data handled using multiple imputation. Internal validation was undertaken via bootstrapping, obtaining optimism-adjusted estimates of the model's performance. Interviews and focus groups with clinicians were conducted to establish clinically relevant risk thresholds and understand the acceptability and perceived utility of the model.ResultsWe included seven factors in the prediction model that are predominantly assessed in clinical practice in patients with FEP. The model predicted treatment resistance among the 1081 patients with reasonable accuracy; the model's C-statistic was 0.727 (95% CI 0.723–0.732) prior to shrinkage and 0.687 after adjustment for optimism. Calibration was good (expected/observed ratio: 0.999; calibration-in-the-large: 0.000584) after adjustment for optimism.ConclusionsWe developed and internally validated a prediction model with reasonably good predictive metrics. Clinicians, patients and carers were involved in the development process. External validation of the tool is needed followed by co-design methodology to support implementation in early intervention services.
The subgroup analysis by age and geriatric assessment in a phase III study comparison of trastuzumab emtansine with trastuzumab, pertuzumab, and docetaxel in older patients with advanced stage HER2-positive breast cancer (JCOG1607 HERB TEA study).
Authors: Shimomura Akihiko , Tamura Kenji , Sasaki Keita , Sadachi Ryo , Suto Akihiko , Sawaki Masataka , Sagara Yasuaki , Yamamoto Naohito , Yoshiyama Tomoyuki , Hayashi Takako , Tokunaga Eriko , Yamanaka Takashi , Shimizu Chikako , Shien Tadahiko , Iwata Hiroji 
Published: August 2024

1031 Background: The JCOG1607, HERB TEA Study, is a phase III trial that compared trastuzumab emtansine (T-DM1) with the HPD regimen (trastuzumab, pertuzumab, docetaxel) in older patients with advanced HER2-positive breast cancer. The primary objective was to confirm the non-inferiority of T-DM1 to HPD in overall survival (OS), with a margin of 1.35 for hazard ratio (HR). The trial was terminated early due to futility at the planned first interim analysis. T-DM1 didn't show non-inferiority to HPD in OS (HR 1.263; 95% confidence interval [CI], 0.677-2.357). Median progression-free survival (PFS) was 11.3 months for T-DM1 and 15.6 months for HPD (HR 1.373; 95% CI, 0.917-2.056). However, the condition of older patients varies widely, and we conducted a subgroup analysis to investigate the subgroup that could benefit from T-DM1 with fewer side effects as a first-line treatment. Methods: Subgroup analysis for OS and PFS involved 148 patients enrolled in JCOG1607, considering age and PS (<75 years old and PS 0,1 or <75 years old and PS 2 or ≥75 years old), Geriatric 8 (G8) score (≥15 or <15), Instrumental Activity of Daily Living (IADL) score (8 or <8), visceral/brain metastasis presence (with or without), and other factors. Results: Subgroup of <75 and PS 2 was not evaluable. For OS, HR of T-DM1 arm to HPD arm was 0.749 (95% CI: 0.310-1.808) in the group aged <75 years, while 2.867 (95%CI: 1.018-8.069) in the group aged ≥75 years (Table). G8 score and the IADL score did not show significant differences in HR for OS, although low G8 score group and low IADL score group tended to have higher OS in HPD arm than T-DM1 arm: HR of T-DM1 arm to HPD arm of 1.541 (95% CI: 0.755-3.142) in low G8 score group and 2.147 (95% CI: 0.656-7.025) in low IADL score group. For PFS, patients with visceral/brain metastasis had HR of T-DM1 arm to HPD arm of 1.794 (95% CI: 1.092-2.948). No other subgroup showed a significant difference in HR for PFS. Conclusions: No subgroups benefiting from T-DM1 as first-line treatment were identified. HPD remains the standard for advanced HER2-positive breast cancer, regardless of age (even in ≥75 years) G8 score, or IADL. Clinical trial information: UMIN000030783. [Table: see text]
Updated results from ALTER-S002: A single-arm multicenter trial of the combination of anlotinib with chemotherapy in patients with stage IIB classic osteosarcoma of the extremity.
Authors: Tang Fan , Zhou Yong , Ma Jie , Wang Dong , Zhang Bing , Luo Yi , Li Longqing , Liu Cuizhen , Nie Yuan , Min Li , Tu Chongqi 
Published: August 2024

11529 Background: The overexpression of multiple tyrosine kinase receptors in osteosarcoma indicated a promising therapy targeting these receptors. Anlotinib is a multi-targeted tyrosine kinase inhibitor that potentially inhibits tumor angiogenesis. The combination of anti-angiogenic drugs with chemotherapeutic agents is proposed to act synergistically to achieve favorable tumor control, especially as the neoadjuvant therapy. We had reported the neoadjuvant therapy data of anlotinib in combination with chemotherapy for treatment-naive stage IIB classical osteosarcoma of the extremity in the 2023 ESMO congress. Here we report an update on the effectiveness and safety of the follow-up. Methods: In this open-label, single-arm, multicenter phase II clinical trial. Eligible patients(pts) were aged 12-40 years with histologically confirmed primary localized extremity classic osteosarcoma, stage IIB, operable. Pts received anlotinib (10mg, po, d1-14, q3w), doxorubicin (A) (20-25mg/m2 iv, d1-3, q3w) and cisplatin (P) (70-90mg/m2, iv, d1, q3w) for the first nine weeks. Pts underwent radical surgery after the exclusion of contraindications at week 10. After surgery, pts received A+P at weeks 12-14, and anlotinib plus A+P at weeks 15-20 with the drug dose unchanged. Since week 21, anlotinib (12mg, po, d1-14, q3w) monotherapy was maintained until week 104 or the occurrence of an EFS event. The primary endpoint was 24-month EFS rate, secondary endpoints were 36-month EFS rate, local recurrence rate, lung metastasis rate, 3-year OS rate and safety. Results: From May 2020 to Apr 2022, 52 eligible pts were enrolled, while 51 pts underwent surgery after 3 cycles of neoadjuvant therapy. At the data cut-off date (Oct. 2023), the median EFS was not reached, 12 and 24-month EFS rates were 84.18% (95% CI :70.82, 91.77) and 73.43% (95% CI :57.40, 84.21), respectively. The stratified analysis of EFS showed that the length and diameter of the target lesion are independent prognostic factors. The median OS was not reached, the 24-month OS rate was 95.92% (95% CI :84.65, 98.96). Among the 51 pts who underwent surgical treatment, 12(23.53%, 95% CI: 12.79, 37.49) pts experienced recurrence or metastasis. Most treatment-related adverse events (TRAEs) were grade 1-2. Grade 3/4 TRAEs (≥20%) included neutropenia (51.92%), leukopenia (38.46%), thrombocytopenia (36.54%) and anemia (32.69%). Conclusions: The updated results suggested that anlotinib combined with doxorubicin and cisplatin in the perioperative period showed favorable efficiency and manageable adverse events in Stage IIB classic osteosarcoma of the extremity. Clinical trial information: ChiCTR 2000033298.
Efficacy and safety of SHR-2554 in advanced epithelioid sarcoma: A phase 2 trial.
Authors: Zhou Yan , Ding Xiaomin , Zhang Yawen , Liang Jinrong , Xu Hongli , Tian Luyuan , Zhao Changhong , Hu Haiyan 
Published: August 2024

11549 Background: Epithelioid sarcoma (ES) is a rare and aggressive subtype of soft-tissue sarcoma. The loss of SMARCB1 (INI1) expression which leads to oncogenic dependence on the transcriptional repressor EZH2 has been observed in over 90% of ES. Patients (pts) with metastatic ES have a poor prognosis. We investigated the efficacy and safety of SHR-2554, an oral selective EZH2 inhibitor, in pts with refractory ES. Methods: To be eligible for inclusion, pts had to fulfill the following criteria: 8 years or older; histologically confirmed advanced or metastatic ES with loss of INI1 or upregulated mRNA level of EZH2; progressive disease after at least one line of doxorubicin-containing chemotherapy; the presence of measurable disease according to RECIST 1.1; an ECOG performance status of 0-1. Pts received SHR2554 (350 mg, bid, po) until disease progression or unacceptable toxicity. The primary endpoint was progression-free rate at 12 weeks. A Simon two-stage design was applied. If there were 3 pts remaining progression-free at 12 weeks within the first 9 pts, the cohort would expand to 17 pts and the outcome would be positive if more than 7 pts remained progression-free at 12 weeks. Results: Between Jul 2021 and Dec 2023, a total of 17 pts were enrolled and received at least 1 dose of SHR-2554. The median age was 32 years (range 8-57) and 41.2% were males. 9 (52.9%) pts had received immunotherapy targeting PD-1/L1 and 6 (35.3%) pts had received anti-angiogenesis therapy before enrollment. The median line of previous treatment was 2 (range 1-4). Loss of INI1 was confirmed in 14 (82.4%) pts. Tumor response was evaluated in 14 pts at data cutoff. 9 (64.3%) of 14 pts remained progression-free at 12 weeks. The primary endpoint was met. Based on investigator assessment, 3 (21.4%) of 14 pts achieved partial response and 8 (57.1%) pts had stable disease as best response. Adverse events (AEs) were generally mild. The most common treatment-related hematological AEs were anaemia, platelet count decreased and hyperuricaemia. Conclusions: SHR-2554 showed promising efficacy and an acceptable safety profile in pts with refractory ES, warranting further investigation. Clinical trial information: ChiCTR2100046099.
An Indian real-world experience of intravenous fosnetupitant-palonosetron (IV NEPA) in preventing delayed and extended delayed CINV.
Authors: Barkate Hanmant V. , Pednekar Dr. Amullya , Shukla Pragya , Valame Shaunak , Nanda Siddhartha , Hanji Abhinandan , Shakya Naval Kishore , Verma Arun Kumar , Bhagat Sagar B , Patil Saiprasad , Bhushan Sumit 
Published: August 2024

12070 Background: Although the reports suggest 15-25% cancer patients receiving highly- and moderately emetogenic chemotherapy (HEC and MEC) experience nausea and vomiting beyond day 5, majority of clinical trials focus on delayed chemotherapy induced nausea and vomiting (CINV) only during the first 5 days of treatment. Here we present a real world observational data with fixed combination of IntraVenous (Fos)NEtupitant and Palonosetron (IV NEPA) in preventing nausea/vomiting in delayed and extended delayed phase among patients receiving HEC/MEC. Methods: An open label, single arm, multicentre, phase IV prospective trial was conducted at six centres following individual Institutional Ethics Committee approval (CTRI/2023/04/051951). Patients in acute (0-24hrs), delayed (>24-120hrs), extended delayed (>120-240hrs) phases and extended overall phase (0-240hrs) were assessed for complete response (CR) (no vomiting and no need of rescue medication), complete protection (CP) [CR + no significant nausea (5mm to <25mm) on visual analogue scale], complete control (CC) [CR + no nausea (<5mm)] and safety. Results: Among 178 patients (Males-114, Females-64), 90 (50.56%) received HEC and 88 (49.44%) received MEC regimen. Cisplatin-Paclitaxel (19.10%) and Carboplatin-Paclitaxel (35.39%) were the most common HEC and MEC regimens respectively. Overall, CR in delayed and extended delayed phases were 93.26% and 96.07% respectively. Furthermore, CP and CC in delayed and extended delayed phases were 92.13% and 96.07% and 81.46% and 90.45% respectively (Table). In general, IV NEPA was well tolerated, as only 9.55% of patients experienced adverse events with 95.83% of them being mild in nature. Headache (2.25%) and injection site reactions (1.68%) were the most common adverse effect reported. Conclusions: IV NEPA demonstrated high efficacy and good tolerability in a real world Indian setting, exhibiting response rates of >92% in both delayed and extended delayed phases in patients receiving HEC/MEC regimens. Clinical trial information: CTRI/2023/04/051951. [Table: see text]
Routine, prospective DPYD genotyping guided dose-individualisation for patients receiving fluoropyrimidines: Implementation, prevalence and patient safety outcomes from a multi-institutional clinical trial.
Authors: Nalder Mark , Kulasegaran Tivya , Lundie Ben , Woods Rick , Eastgate Melissa A. , Wyld David , Burge Matthew E. 
Published: August 2024

12121 Background: Prospective data regarding the prevalence of DPYD variant alleles and the impact of genotype guided dosing on safety and efficacy of fluoropyrimidines (FP) remains limited. We assessed the feasibility and safety impact of routine, prospective, DPYD genotype guided FP dosing. Methods: Adult patients (>18 years), commencing FP for the first time were enrolled. Sanger PCR sequencing was designed to target DPYD variants NM_000110.4:c.1905+1G>A (DPYD*2A), NM_000110.4:c.1679T>G (DPYD*13), NM_000110.4:c.1236G>A and NM_000110.4:c.2846A>T. Dose reductions were implemented as per current international pharmacogenomic guidelines. Gr3/4 toxicity, dose reductions/delays and hospital admissions were reviewed for the first 60 days after commencement. For comparison purposes, a retrospective review of patients receiving FP without testing in a prior year was completed. Results: Between July 2021 – May 2023, 334 patients were enrolled for testing. 95% ECOG 0-1. 57% curative treatment intent. Mean time from phlebotomy to result 6.9 days (range 2-15). Clinician/patient acceptance was high (>95% of eligible patients starting FP were enrolled). 20 (6.0%) variant DPYD allele carriers were detected. 11 heterozygous for c.1236G>A, 5 heterozygous for C.1905+1G>A, 3 heterozygous for c.2846A>T and 1 homozygous for c.1236G>A. 295 of patients tested proceeded to receive FP. 62% received Infusional-FP, 38% Capecitabine. 39 patients commenced treatment prior to DPYD result being available (treating clinician decision). Dose modification recommendations were followed in all but two patients. 24% experienced FP related Grade 3/4 toxicity within 60 days. (23% DPYD wild type, 37% DPYD variant) versus 35% in the retrospective cohort. 16% had FP related dose delays (16% DPYD wild type, 12% DPYD variant) versus 25% retrospective cohort. 14% had FP related dose reductions (13% DPYD wild type, 25% DPYD variant) versus 12% retrospective cohort. 13% had FP related hospital admissions (13% DPYD wild type, 19% DPYD variant) versus 17% retrospective cohort. 1 death in the DPYD wild type cohort was deemed potentially related to FP. Conclusions: Prospective DPYD genotype guided dosing was feasible in clinical practice, with prevalence of variant alleles comparable to published literature. There was a modest reduction in risk of FP related severe toxicity, dose delays, and hospital admissions with DPYD guided dosing compared to a historical, untested cohort. Clinical trial information: ACTRN12621001117808.