bluuebunny/crossref_metadata_2025_split huggingface dataset:
Immunotherapy plus chemotherapy versus chemotherapy alone in perioperative treatment for locally advanced gastric cancer: A systematic review and meta-analysis.
Authors: Silva Isadora Mamede Mendes da , Oliveira João Pedro , Maia Melissa , de Liz Caio Dabbous , Oliveira Audrey Cabral Ferreira de , Alves Ana Caroline Fonseca 
Published: July 2024

e16083 Background: The standard care for locally advanced gastric (LAGC) or gastroesophageal junction (GEJ) cancer is perioperative chemotherapy (CTX) with surgery. The therapeutic landscape has evolved with PD-1 and PD-L1 inhibitors, showing promise in advanced or metastatic disease. Investigating their role in locally advanced disease is an active research area. In response, we conducted a meta-analysis to evaluate the effectiveness of perioperative immunotherapy with CTX in LAGC/GEJ patients. Methods: We systematically searched PubMed, Embase, and Cochrane for randomized controlled trials (RCTs) comparing perioperative PD-1 and PD-L1 inhibitors in combination with CTX versus CTX alone for LAGC/GEJ. Evaluated outcomes included pathological complete response (pCR), R0 resection rate, downstaging rate, and treatment-related adverse events (TRAE) with a grade ≥ 3. Heterogeneity was assessed using I2 statistics, employing a random-effects model for analysis. Statistical analyses were performed using R software version 4.3.2. Results: Among 2,452 patients from six RCTs, 1,228 (50.08%) received immunotherapy. Combining immunotherapy with CTX showed substantial improvements in pCR (RR 2.83; 95% CI 1.78-4.50; p < 0.001). This effect persisted in the FLOT CTX subgroup (RR 2.15; 95% CI 1.37-3.38; p < 0.001). Additionally, downstaging outcomes were superior in the immunotherapy group, with ypT0 (RR 1.96; 95% CI 1.50-2.55; p < 0.001) and ypN0 (RR 1.36; 95% CI 1.19-1.54; p < 0.001). However, no significant differences were observed in the R0 resection rate (RR 1.01; 95% CI 0.98-1.04; p = 0.603) and TRAE grade 3 or higher (RR 1.05; 95% CI 0.98-1.13; p = 0.177). Conclusions: These findings emphasize the effectiveness of combining PD-1 and PD-L1 inhibitors with CTX, indicating an improved pathological response compared to CTX alone. As expected, these positive outcomes persisted in the FLOT regimen. Our results provide evidence supporting the combination of immunotherapy and CTX as a perioperative treatment option for LAGC/GEJ patients.
A phase 1 trial of TSC-100 and TSC-101, engineered T cell therapies that target minor histocompatibility antigens to eliminate residual disease after hematopoietic cell transplantation.
Authors: Al Malki Monzr M. , Keyzner Alla , Suh Hyung C. , Popat Uday R. , Gill Saar , Chen Yi-Bin Albert , Solh Melhem M. , Gowda Lohith , Buonomo Erica , Wang Yun , Murray Jim , MacBeath Gavin , Barton Debora , Chattopadhyay Shrikanta , Reshef Ran 
Published: July 2024

TPS2678 Background: Engineered T cell therapies such as CAR-T cell therapies have transformed the treatment of B-cell but not non-B cell hematologic malignancies. Allogeneic hematopoietic cell transplantation (HCT) remains the best curative option for hematologic malignancies but ~40% of patients relapse post-HCT with up to 90% mortality due to residual disease post-HCT. A potential solution is targeting minor histocompatibility antigens (MiHAs) that are homogenously expressed on all hematopoietic cells and are genetically mismatched between donors and patients undergoing HCT. These mismatches enable engineered T cells to selectively eliminate residual patient hematopoietic cells, normal or malignant, leaving donor cells untouched. TScan has developed allogeneic donor derived T-cell products TSC-100 and TSC-101, targeting MiHAs HA-1 and HA-2 respectively, both presented on HLA-A*02:01. By choosing HCT patients who are HLA-A*02:01 positive (>98% of whom are either HA-1 or HA-2 positive) and donors who are either HLA-A*02:01 or MiHA negative, TSC-100 or TSC-101 can potentially eliminate all residual patient-derived hematopoietic cells after HCT, to prevent disease relapse. Methods: Study NCT05473910 is a multi-center, multi-arm, non-randomized controlled Phase 1 umbrella study evaluating the feasibility, safety and preliminary efficacy of TSC-100 and TSC-101. Inclusion criteria include adults with AML, MDS or ALL eligible for reduced intensity conditioning-based haploidentical donor transplantation from HLA or MiHA mismatched donors. HLA-A*02:01-positive patients undergo HA-1/ HA-2 testing and are assigned to either TSC-100 or TSC-101 treatment arms in addition to HCT. HLA-A*02:01-negative patients in the control arm receive HCT alone. Upon count recovery after HCT, patients in treatment arms receive either TSC-100 or TSC-101, administered as single or two doses. Primary endpoints include adverse event profiles and dose limiting toxicities. Secondary endpoints include relapse rates, disease-free survival and overall survival. Exploratory endpoints include surrogates of efficacy such as donor chimerism rates and kinetics and minimal residual disease (MRD) rates. Donor chimerism is measured by standard STR-based and novel high-sensitivity NGS-based assays to quantify residual patient-derived hematopoietic cells. MRD is measured before and after HCT using flow cytometry and NGS. Together, these assays measure elimination of residual patient hematopoietic cells, malignant or normal, and could provide early evidence of biological activity. Clinical trial information: NCT05473910 .
Phase I, open-label, dose-escalation trial investigating the safety and efficacy of oncolytic virus BI 1821736 in patients with advanced solid tumors.
Authors: Tolcher Anthony W. , Victoria Iván , Germann Nathalie , Luecke Stephan , Bailey Mark , Kordes Maximilian 
Published: July 2024

TPS2688 Background: Despite some advances, the need for novel anti-cancer therapies remains high in patients with advanced solid tumors. Although immunotherapy with checkpoint inhibitors is the preferred treatment for several cancer types, a proportion of patients will have non-responsive tumors or develop resistance. Oncolytic viruses have potential as novel immunotherapies, due to their tumor-selectivity and ability to stimulate a systemic anti-tumor immune response. BI 1821736 is a genetically engineered pseudotype variant of VSV-GP encoding an immune-stimulatory cargo. The VSV-GP backbone is a recombinant chimeric vesicular stomatitis virus modified to replace the innate neurotropic G glycoprotein with the non-neurotropic GP glycoprotein from the lymphocytic choriomeningitis virus. BI 1821736 selectively replicates and lyses cells with defective interferon signaling, which is seen particularly in cancer cells. The immune-stimulating cargo leads to T-cell priming and reactivation within the immunosuppressed tumor microenvironment. Preclinical efficacy, toxicology, and environmental safety results support BI 1821736 administration in humans. Methods: 1467-0001 (NCT05839600) is a Phase I, open-label, dose-escalation study evaluating the safety and early efficacy of BI 1821736 in patients with advanced solid tumors. The study is enrolling adult patients who have exhausted available treatment options, with an Eastern Cooperative Oncology Group Performance Status of 0 or 1, ≥1 lesion amenable to biopsy, and adequate organ function. Patients with brain metastases are excluded unless they have completed brain radiotherapy and are asymptomatic. Patients will receive escalating doses of intravenous BI 1821736 for up to 3 months. Dose escalation will be guided by a Bayesian 2-parameter logistic regression model with overdose control (BLRM-EWOC). The primary objective is to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose based on occurrence of dose-limiting toxicities (DLTs) during the MTD evaluation period of the first treatment cycle (Cycle 1; 21 days). Other safety endpoints include the occurrence of DLTs and adverse events during the treatment period. Further objectives include the assessment of BI 1821736 preliminary efficacy, pharmacokinetics, immunogenicity, shedding, and biomarkers. Patients are being recruited from approximately 10 sites across North America and Europe. Enrollment began in May 2023. A total of six patients have received BI 1821736 as of January 29, 2024. Patients are currently being enrolled to dose level 2. Clinical trial information: NCT05839600 .
A first-in-human phase I study of ATG-031, anti-CD24 antibody, in patients with advanced solid tumors or B-cell non-Hodgkin lymphomas (PERFORM).
Authors: Fu Siqing , Piha-Paul Sarina A. , Singh Shivani , Peng Jing , Keenan Bridget P. , Mei Jay M. , Lynch Kevin , Li Ling , Song Ming , Zhang Xiaojing (Amily) 
Published: July 2024

TPS2691 Background: ATG-031 is a first-in-class humanized cluster of differentiation 24 (CD24) antibody. By disrupting the interaction between CD24, a ‘do not eat me’ signal on cancer cells, and the inhibitory receptor Siglec-10 on tumor-associated macrophages (TAMs), it enhances macrophage-mediated phagocytosis of cancer cells and promotes cytotoxic T cell function in the tumor microenvironment. ATG-031 also triggers antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) towards target tumor cells through its immunoglobulin gamma 1 (IgG1) Fc-dependent effects. Preclinical studies indicated that ATG-031-induced phagocytosis transforms macrophages from a tumor-tolerant M2 phenotype to an antitumor M1 phenotype, significantly inhibiting tumor growth both as monotherapy and synergistically with immune checkpoint inhibitors (ICI) and/or chemotherapies in mouse models. Methods: ATG-031 is undergoing evaluation for safety and preliminary antitumor efficacy in a Phase I, multi-center, open-label clinical study, PERFORM (NCT04986865), in patients with advanced solid tumors or B-cell non-Hodgkin’s lymphoma. The study includes a dose escalation phase and a dose expansion phase. The dose escalation phase enrolls patients with advanced solid tumors (preferred tumor types: lung cancer, breast cancer, ovarian cancer, urothelial cancer, and liver cancer) using a Bayesian Optimal Interval (BOIN) design with 3 to 9 patients at each dose level. A priming dose, defined as an initial lower dose followed by escalation to the full treatment dose, will be applied if Grade ≥2 cytokine release syndrome (CRS) is observed during the dose-limiting toxicity (DLT) period. The dose expansion phase will enroll patients with specific tumor types and will randomize patients into two or more dose levels to determine the recommended Phase II dose (RP2D). The PERFORM study explores an intravenous dose of ATG-031 once every 21 days (1 cycle) to assess DLT during the first two treatment cycles in dose escalation. Key inclusion criteria include histological or cytological confirmation of a solid tumor that has relapsed or has been refractory to standard therapy, at least one measurable lesion per RECIST, and an ECOG performance status of 0 to 1. The study excludes patients with CNS malignancies and those who have experienced Grade ≥3 immune-related adverse events (irAEs) or irAEs leading to prior immunotherapy discontinuation. As of January 2024, 2 sites in the United States have initiated the study, and 4 patients have received ATG-031 treatment at 0.03mg/kg (dose level 1). Clinical trial information: NCT04986865 .
Complete Corpus Callosotomy Brings Worthwhile Seizure Reduction in Both Pediatric and Adult Patients
Authors: Ukishiro Kazushi , Osawa Shin-ichiro , Iwasaki Masaki , Kakisaka Yosuke , Jin Kazutaka , Uematsu Mitsugu , Yamamoto Tetsuya , Tominaga Teiji , Endo Hidenori , Nakasato Nobukazu 
Published: July 2024

BACKGROUND AND OBJECTIVES:
The influence of the age at which complete corpus callosotomy (CC) surgery is performed on seizure outcomes remains unclear. This study aimed to evaluate the age-dependent aspects of long-term seizure outcomes after complete CC.

METHODS:
We reviewed 41 patients who underwent one-stage complete CC. Seizure outcomes were analyzed for age at epilepsy onset and at complete CC, focal MRI abnormality, and etiology.

RESULTS:
The median age was 7 months at epilepsy onset and 93 months at complete CC. The median follow-up duration was 67 months. Sixteen patients had focal MRI lesions and 4 had only general atrophy. Etiology was identified in 20 patients. For overall seizure outcomes (N = 41), complete seizure freedom was achieved in 5 patients, excellent seizure reduction (>80%) in 11, good (50%-80%) in 5, and poor (<50%) in 20. Freedom was correlated with younger age at complete CC and unknown etiology (P ≤ .05). Freedom was only achieved in patients aged younger than 7 years. Worthwhile (≥50%, freedom, excellent, and good) and not worthwhile (<50%, poor) overall seizure reduction showed no statistical difference in age at complete CC. No related factor was found for worthwhile overall seizure reduction. For drop attack outcomes (N = 31), freedom was achieved in 22 cases, excellent in 5, and poor in 4. Freedom was correlated with younger age at complete CC (P < .05) although freedom was achieved in 4 of 7 patients older than 20 years. Age at complete CC showed no statistical difference between worthwhile (≥50%) and not worthwhile (<50%) drop attack reduction. Worthwhile drop attack reduction was correlated with unknown etiology (P < .05). Complications were mild and transient.

CONCLUSION:
Complete CC is an excellent surgical option based on favorable seizure outcomes and acceptable complications in our present study.
Curative effect of hydrogen peroxide combined with silver ion disinfection on pelvic floor dysfunction
Authors: Zhou Wei , Guo Hua 
Published: June 2024

BACKGROUND
Pelvic floor dysfunction (PFD) is related to muscle fiber tearing during childbirth, negatively impacting postpartum quality of life of parturient. Appropriate and effective intervention is necessary to promote PFD recovery.
AIM
To analyze the use of hydrogen peroxide and silver ion disinfection for vaginal electrodes in conjunction with comprehensive rehabilitation therapy for postpartum women with PFD.
METHODS
A total of 59 women with PFD who were admitted to the hospital from May 2019 to July 2022 were divided into two groups: Control group (n = 27) received comprehensive rehabilitation therapy and observation group (n = 32) received intervention with pelvic floor biostimulation feedback instrument in addition to comprehensive rehabilitation therapy. The vaginal electrodes were disinfected with hydrogen peroxide and silver ion before treatment. Intervention for both groups was started 6 weeks postpartum, and rehabilitation lasted for 3 months. Pelvic floor muscle voltage, pelvic floor muscle strength, vaginal muscle voltage, vaginal muscle tone, pelvic floor function, quality of life, and incidence of postpartum PFD were compared between the two groups.
RESULTS
Before comprehensive rehabilitation treatment, basic data and pelvic floor function were not significantly different between the two groups. After treatment, the observation group showed significant improvements in the maximum voltage and average voltage of pelvic floor muscles, contraction time of type I and type II fibers, pelvic floor muscle strength, vaginal muscle tone, vaginal muscle voltage, and quality of life (GQOLI-74 reports), compared with the control group. The observation group had lower scores on the pelvic floor distress inventory (PFDI-20) and a lower incidence of postpartum PFD, indicating the effectiveness of the pelvic floor biostimulation feedback instrument in promoting the recovery of maternal pelvic floor function.
CONCLUSION
The combination of the pelvic floor biostimulation feedback instrument and comprehensive rehabilitation nursing can improve pelvic floor muscle strength, promote the recovery of vaginal muscle tone, and improve pelvic floor function and quality of life. The use of hydrogen peroxide and silver ion disinfectant demonstrated favorable antibacterial efficacy and is worthy of clinical application.
Influence of a diet meal plan on pepsinogen I and II, gastrin-17, and nutritional status in gastric ulcer patients
Authors: Zhang Wei-Wei , Wang Xiao-Fei , Yu Hai-Yan , Wang Ling-Fang 
Published: June 2024

BACKGROUND
Gastric ulcers (GUs) have a high risk of clinical morbidity and recurrence, and further exploration is needed for the prevention, diagnosis, and treatment of the disease.
AIM
To investigated the effects of a diet plan on pepsinogen (PG) I, PG II, gastrin-17 (G-17) levels and nutritional status in patients with GUs.
METHODS
A total of 100 patients with GUs treated between May 2022 and May 2023 were enrolled, with 47 patients in the control group receiving routine nursing and 53 patients in the experimental group receiving dietary nursing intervention based on a diet plan. The study compared the two groups in terms of nursing efficacy, adverse events (vomiting, acid reflux, and celialgia), time to symptom improvement (burning sensation, acid reflux, and celialgia), gastric function (PG I, PG II, and G-17 levels), and nutritional status [prealbumin (PA) and albumin (ALB) levels].
RESULTS
The experimental group showed a markedly higher total effective rate of nursing, a significantly lower incidence of adverse events, and a shorter time to symptom improvement than the control group. Additionally, the experimental group’s post-intervention PG I, PG II, and G-17 levels were significantly lower than pre-intervention or control group levels, whereas PA and ALB levels were significantly higher.
CONCLUSION
The diet plan significantly reduced PG I, PG II, and G-17 levels in patients with GUs and significantly improved their nutritional status.
Survey on hospice care attitude of family members of advanced cancer patients at different ages
Authors: Liu Xiao-Li , Li Lun-Lan 
Published: June 2024

BACKGROUND
Hospice care plays an important role in improving the quality of life of advanced cancer patients, but controversy remains over whether age affects the attitudes of family members toward hospice care.
AIM
To investigate the attitudes of family members of advanced cancer patients of different ages toward hospice care.
METHODS
The study participants were 175 family members of patients with advanced cancer from January 2020 and October 2022. The participants were divided into youth (< 40 years, n = 65), middle-aged (40–60 years, n = 59), and elderly (> 60 years, n = 51) groups. Researchers investigated and compared the degree of awareness regarding hospice care, attitudes, and whether the family members of patients would choose hospice care.
RESULTS
Among the family members of 175 patients, approximately 28% (49/175) were aware of hospice care. Awareness of hospice care, the proportion of hospice care acceptance and adaptation attitudes, and the proportion of those who chose hospice care in the youth group were higher in the middle-aged and elderly groups (P < 0.05). No statistically significant difference was found in these three indicators between the middle-aged and elderly groups (P > 0.05). Hospice care was chosen mainly to relieve pain and reduce unnecessary treatment, whereas the reasons for not choosing hospice care were mainly distrust and ethical concerns.
CONCLUSION
The family members of patients with advanced cancer had relatively low awareness of hospice care, while youth had a higher awareness of hospice care, acceptance, and adaptation attitudes, and were more willing to choose hospice care.
Predicting depression in patients with heart failure based on a stacking model
Authors: Jiang Hui , Hu Rui , Wang Yu-Jie , Xie Xiang 
Published: June 2024

BACKGROUND
There is a lack of literature discussing the utilization of the stacking ensemble algorithm for predicting depression in patients with heart failure (HF).
AIM
To create a stacking model for predicting depression in patients with HF.
METHODS
This study analyzed data on 1084 HF patients from the National Health and Nutrition Examination Survey database spanning from 2005 to 2018. Through univariate analysis and the use of an artificial neural network algorithm, predictors significantly linked to depression were identified. These predictors were utilized to create a stacking model employing tree-based learners. The performances of both the individual models and the stacking model were assessed by using the test dataset. Furthermore, the SHapley additive exPlanations (SHAP) model was applied to interpret the stacking model.
RESULTS
The models included five predictors. Among these models, the stacking model demonstrated the highest performance, achieving an area under the curve of 0.77 (95%CI: 0.71-0.84), a sensitivity of 0.71, and a specificity of 0.68. The calibration curve supported the reliability of the models, and decision curve analysis confirmed their clinical value. The SHAP plot demonstrated that age had the most significant impact on the stacking model's output.
CONCLUSION
The stacking model demonstrated strong predictive performance. Clinicians can utilize this model to identify high-risk depression patients with HF, thus enabling early provision of psychological interventions.
Percutaneous cervical cordotomy for managing refractory pain in a patient with a Pancoast tumor: A case report
Authors: Lu Kuan-Yu , Lin Feng-Sheng , Lin Chia-Shiang , Lao Hsuan-Chih 
Published: June 2024

BACKGROUND
According to the World Health Organization analgesic ladder, cancer-related pain generally begins with pharmacotherapy in a stepwise approach. Nevertheless, some patients continue to experience poorly controlled pain despite medications, particularly when considering adverse effects and self-care quality. Percutaneous cervical cordotomy is an alternative interventional procedure for unremitting unilateral intractable cancer-related pain.
CASE SUMMARY
The patient was diagnosed with lung cancer with destruction of the brachial plexus and ribs. For 2 mo, the patient experienced progressive severe weakness and pain in the right upper extremity. Notably, the pain intensity reached an extreme level, particularly when lying supine, even under heavy sedation. This heightened pain response posed a significant challenge; as a result, the patient was unable to undergo further evaluation through magnetic resonance imaging. Ultimately, he underwent percutaneous cervical cordotomy for symptom relief, resulting in complete resolution of right arm pain. After a 3-mo follow-up, the pain did not recur, and only a flurbiprofen local patch was required for mild scapular tightness.
CONCLUSION
Cordotomy, under careful patient selection, appears to enhance the quality of life of patients with unilateral cancer-related pain.
Hysteroscopic cervical biopsy for women with persistent human papillomavirus infection after loop electrosurgical excision procedure: A case report
Authors: Li Hui , Mei Shan-Shan , Mao Pei-Yu , Wang Xin-Yan , Yang Hua-Di 
Published: June 2024

BACKGROUND
Almost all cases of cervical cancer can be attributed to human papillomavirus (HPV) infection. The loop electrosurgical excision procedure (LEEP) is widely used to treat HPV-mediated disease; thus, cervical cancer is highly preventable. However, LEEP does not necessarily clear HPV rapidly and may affect the accuracy of the results of ThinPrep cytology test (TCT) and cervical biopsy due to the formation of cervical scars.
CASE SUMMARY
A 40-year-old woman underwent LEEP for cervical intraepithelial neoplasia grade 1 approximately 10 years ago. Subsequent standard cervical cancer screening suggested persistent HPV-52 infection, but TCT results were negative. Cervical biopsy under colposcopy was performed thrice over a 10-year period, yielding negative pathology results. She developed abnormal vaginal bleeding after sexual activity, persisting for approximately 1 year, and underwent hysteroscopy in our hospital. Histopathologic evaluation confirmed adenocarcinoma in situ of the uterine cervix.
CONCLUSION
Patients with long-term persistent, high-risk HPV infection and negative pathology results of cervical biopsy after LEEP are at risk of cervical cancer. Hysteroscopic resection of cervical canal tissue is recommended as a supplement to cervical biopsy because it helps define the lesion site and may yield a pathologic diagnosis.