bluuebunny/crossref_metadata_2025_split huggingface dataset:
Developing machine learning–based prognostic models for gestational choriocarcinoma: Insights into treatment efficacy and patient survival.
Authors: Alshwayyat Mustafa , Alshwayyat Sakhr Abdulsalam , Kamal Haya , Alshwayyat Tala Abdulsalam , Alenezy Abdalwahab 
Published: June 2024

e17607 Background: Gestational Choriocarcinoma (GCC) is a highly aggressive tumor derived from syncytiotrophoblasts. There is currently controversy surrounding the initiation of chemotherapy for patients with GCC. We aimed to investigate the influence of chemotherapy on survival rates and develop machine-learning-based prognostic models for GCC patients to improve treatment decisions and personalized medicine. Methods: Data were obtained from the Surveillance, Epidemiology, and End Results database (2000–2020). Patients who met any of the following criteria were excluded: diagnosis not confirmed by histology, previous history of cancer or with other concurrent malignancies, and unknown data. To identify prognostic variables, we conducted Cox regression analysis and constructed prognostic models using machine learning (ML) algorithms to predict the 5-year survival. Patient records were randomly divided into training (70 %) and validation (30 %) sets. A validation method incorporating the area under the curve (AUC) of the receiver operating characteristic curve was used to validate the accuracy and reliability of the ML models. We also investigated the role of multiple therapeutic options using Kaplan-Meier survival analysis. Results: This study included 732 patients, of whom 283 received chemotherapy, 116 underwent surgery alone, and 333 underwent both surgery and chemotherapy. Most patients (54.5%) were aged 30 years or older, with a median age of 32 years. The largest racial group was white, comprising 66.4% of cases, followed by black (16.7 %). Furthermore, most cases were localized (n=262), and only 13% presented with stage IV disease and 44.3% with metastasis. Survival analysis showed no significant differences in survival between the treatment modalities. Multivariate Cox regression analysis identified older age, unmarried status, and AJCC stage II as significant prognostic factors. The random forest classifier (RFC) and K-Nearest Neighbors (KNN) were the most accurate ML models, with the AJCC stage, race, and SEER stage as key factors. Performance metrics for all ML algorithms are summarized in the Table. Conclusions: Our study provides a novel and practical tool for GCC prognosis and management. Although our tool offers a valuable resource for personalized clinical decisions, further research is needed to better understand the role of chemotherapy in GCC treatment and its impact on patient outcomes. [Table: see text]
Zanzalintinib (XL092) plus nivolumab in non-clear cell renal cell carcinoma: The randomized phase 3 STELLAR-304 study.
Authors: Pal Sumanta Kumar , Powles Thomas , Kanesvaran Ravindran , Liu Mohan , Wang Zhong , Bhatt Aarohi , Patel Pritesh , Suárez Cristina 
Published: June 2024

TPS4611 Background: Non-clear cell renal cell carcinoma (nccRCC) is a heterogenous group of rare, histologic subtypes with limited treatment options. There have been few dedicated randomized controlled studies in nccRCC, and novel treatment options supported by data from robust clinical trials are needed. Sunitinib, a tyrosine kinase inhibitor (TKI), is a commonly used therapy for nccRCC based on clinical benefit demonstrated in phase 2 trials. To date, no treatment has shown a significant overall survival (OS) improvement over sunitinib in any nccRCC subtype. Monotherapy with immune checkpoint inhibitors (ICIs) has shown only modest response rates, but TKI-ICI combinations have shown promising clinical activity in single-arm phase 2 trials. Zanzalintinib is a novel, multi-targeted TKI of VEGFR, MET, and the TAM kinases (TYRO3, AXL, MER) which are involved in tumor angiogenesis, metastasis, and immunosuppression. Zanzalintinib has shown antitumor and immunomodulatory activity in animal models when used alone or in combination with ICIs (Hsu et al. Mol Cancer Ther. 2023). In the phase 1 STELLAR-001 study, single-agent zanzalintinib showed promising antitumor activity (38% objective response rate [ORR] and 88% disease control rate) and a manageable safety profile in patients with heavily pretreated advanced clear-cell RCC (Pal et al. IKCS NA 2023. Abs 1). STELLAR-304 was designed to assess the efficacy and safety of zanzalintinib + nivolumab versus sunitinib in previously untreated advanced nccRCC. Methods: STELLAR-304 (NCT05678673) is a phase 3, global, randomized, open-label study enrolling patients ≥18 years of age with unresectable/advanced/metastatic nccRCC. Patients must have measurable disease per RECIST v1.1, a Karnofsky performance status of ≥70%, and papillary, unclassified, or translocation-associated histology (sarcomatoid features are allowed). Patients with chromophobe, renal medullary carcinoma, or pure collecting duct histology are excluded. Prior systemic anticancer therapy for advanced/metastatic nccRCC is not allowed; however, one prior systemic adjuvant therapy, including ICI (but excluding sunitinib), is permitted for completely resected RCC if recurrence occurred ≥6 months after the last adjuvant therapy dose. Patients (N=291) are randomized 2:1 to receive treatment with zanzalintinib + nivolumab, or sunitinib alone. The dual primary endpoints are progression-free survival and ORR per RECIST v1.1 by blinded independent radiology committee. The secondary endpoint is OS; safety will also be assessed. STELLAR-304 is currently recruiting patients in Europe, North and South America, and the Asia-Pacific region. Clinical trial information: NCT05678673 .
SOGUG-NEOWIN: A phase 2, open-label, multi-centre, multi-national interventional trial evaluating the efficacy and safety of erdafitinib (ERDA) monotherapy and ERDA and cetrelimab (CET) as neoadjuvant treatment in patients with cisplatin-ineligible muscle-invasive bladder cancer (MIBC) whose tumours express FGFR gene alterations.
Authors: Hussain Syed A. , Loriot Yohann , de Velasco Guillermo , Necchi Andrea 
Published: June 2024

TPS4623 Background: The standard treatment for nonmetastatic MIBC is neoadjuvant cisplatin-based therapy followed by radical cystectomy (RC). However, many patients are ineligible for cisplatin. Immune checkpoint inhibitors (ICIs) have changed the treatment landscape for metastatic urothelial cancer (mUC), including for cisplatin-ineligible patients. Based on these results, ICIs are being explored as neoadjuvant treatment in resectable UC with preliminary data suggesting antitumour activity. ERDA is a Fibroblast Growth Factor Receptor (FGFR) inhibitor, which has shown efficacy in advanced UC with select FGFR2/3 mutations/fusions. ERDA plus cetrelimab demonstrated clinically meaningful activity in patients with newly diagnosed FGFR-altered mUC in the phase 2 NORSE trial. We hypothesize that ERDA plus cetrelimab will improve the pathological complete response (pCR) rate in patients with FGFR+ MIBC who are candidates for RC and are ineligible for or refuse neoadjuvant cisplatin-based therapy. Methods: SOGUG-NEOWIN is a prospective, non-comparative, open label, multicentre, international trial to assess the efficacy of 9 or 12 weeks of neoadjuvant ERDA (cohort 1) or the combination of cetrelimab and ERDA (cohort 2) in patients with MIBC (cT2-Ta N0/1 M0) and FGFR alterations. Key eligibility criteria include ECOG PS 0-1; pure or predominant UC histology; decline or ineligible for cisplatin-based chemotherapy as defined by one of the following criteria: impaired renal function (GFR < 60 mL/min), ≥ grade 2 hearing loss, or ≥ grade 2 peripheral neuropathy; patients are considered fit for cystectomy; no prior FGFR-targeted or anti-PD-(L)1 therapy; no prior systemic therapy, radiation or surgery (except TURBT or biopsies) for bladder cancer; prior BCG was allowed if completed ≥ 6 weeks before initiation of study treatment; no current retinopathy. A total of 45 patients will be allocated to each cohort by a centralized system. Co-primary endpoints are pCR rate and percentage of pathological downstaging response (<ypT2). Secondary endpoints include event-free survival, overall survival, overall response rate, safety, tolerability, and delay to surgery. Biomarkers of response and resistance will be assessed using baseline archival tissues, blood and urine. Quality of life (QoL) will be assessed using FACT-Bl and EQ-5D-5L. Tumour response assessment via PET-MRI will be performed in a subset of patients. The trial is approved in 4 countries. The first patient was included on 31-Jan-2024. This trial would be the first to systematically address whether ERDA ± cetrelimab improves pCR in patients with FGFR-positive MIBC. (EudraCT 2022-002586-15). Clinical trial information: 2022-002586-15.
Safety and immunological effects of ablative radiotherapy followed by pembrolizumab in patients with advanced adrenocortical carcinoma.
Authors: Raj Nitya Prabhakar , Crane Christopher H. , Ziv Etay , Gopalan Anuradha , Chou Joanne F. , Capanu Marinela , Reidy Diane Lauren , Hajj Carla 
Published: June 2024

TPS4630 Background: Adrenocortical carcinoma (ACC) is a rare and aggressive cancer with poor prognosis. While pembrolizumab is a NCCN recommended treatment, our prior study showed no benefit in patients with liver metastases (NCT02673333).1 Preclinical evidence suggests combining liver-directed radiation therapy (RT) with pembrolizumab might enhance anti-tumor immunity.2 Our current study will assess the safety and describe preliminary efficacy data for ablative RT to symptomatic liver metastases followed by treatment with pembrolizumab in patients with advanced ACC. Methods: This is a single-center pilot study. Main inclusion criteria include: adult patients with metastatic ACC with symptomatic liver metastases, presence of extrahepatic metastases, ECOG 0-1. Ablative RT in 5 or 10 once daily fractions will be delivered over 1 to 2 weeks; pembrolizumab treatment (200mg Q3W) will begin one week after RT completion. The primary objective is to evaluate the safety of treatment with ablative RT followed by pembrolizumab. The study will include a 6 patient safety lead-in, with 10 to 12 patients enrolled in total. The secondary endpoint, efficacy, is defined as the objective response (partial and complete response) according to RECIST v1.1, in the hepatic and extrahepatic disease. Correlative objectives include evaluation of the innate and adaptive immune response during treatment through analysis of pre- and on-treatment blood and tumor tissue samples, circulating tumor (ct) DNA analyses, and PD-L1 and next-generation sequencing testing in pre-treatment tumor tissue samples to evaluate for biomarkers of response and resistance. This trial began enrollment in 9/27/2023, with 3 patients enrolled to date. References: 1Raj N, Zheng Y, Kelly V, Katz SS, Chou J, Do RKG, et al. PD-1 Blockade in Advanced Adrenocortical Carcinoma. J Clin Oncol. 2020;38(1):71-80. 2Yu J, Green MD, Li S, Sun Y, Journey SN, Choi JE, et al. Liver metastasis restrains immunotherapy efficacy via macrophage-mediated T cell elimination. Nat Med. 2021;27(1):152-64. Clinical trial information: NCT06066333 .
A phase 1 safety and feasibility study of intratumoral placement of bicalutamide implants combined with radiotherapy for localized prostate cancer.
Authors: Citrin Deborah E. , Turkbey Baris , Patel Krishnan , Harmon Stephanie A , Pinto Peter A , Wood Brad , Gurram Sandeep , Ning Holly , Nathan Debbie-Ann , Desai Pujan K , Rairkar Maithili , Choyke Peter , Munster Pamela N. , Mileti Cassidy 
Published: June 2024

TPS5126 Background: Systemic androgen deprivation therapy (ADT) is an integral part of therapy for unfavorable intermediate or high-risk prostate cancer treated with radiation therapy (RT). However, systemic anti-androgens are associated with considerable cardiovascular, metabolic, and sexual side effects leading to omission and contraindication in many men. We tested the feasibility of replacing systemic ADT with targeted local delivery of an anti-androgen agent (bicalutamide, Biolen Implant). The Biolen implant consists of a medical grade silicone polymer mixed with 6.3mg bicalutamide into a solid rod-shaped scaffold approximately 0.95 x 15 mm in size. Pre-clinical studies have demonstrated that a silicone/bicalutamide implant is a feasible method for durable localized delivery of an anti-androgen into the prostate. Results for the preclinical studies were presented at the AACR Symposium in April 2023 (Poster # 5261). Methods: Trial Design: This study (CP-002, NCT04943536) is a prospective, single-center, single-arm feasibility study to assess the safety, feasibility and PK profile for Biolen for the localized delivery of bicalutamide into the prostate when delivered with radiotherapy. Up to 20 participants with intermediate to high risk localized prostate cancer who are planned to receive RT and are candidates for systemic ADT will be enrolled. Study participants will have placement of the drug eluting Biolen (bicalutamide) implants. Participants will receive standard of care radiation 9 weeks after implant and will be followed through 2 years post radiation. Patients will undergo plasma collection after Biolen implant at Day 1, 3, Week 1, 2, 4 and seminal fluid collection at 4-7 and 8 weeks for assessment of bicalutamide levels. An MRI will be performed at 6 and 24 months after completion of radiation. Key Eligibility: Patients must have at least 1 MRI detected, biopsy proven localized prostate cancer lesion in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer). Patients diagnosed as one of the following: a) NCCN intermediate risk prostate cancer, b) NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, c) NCCN high risk prostate cancer due to PSA > 20 AND refuses to receive systemic ADT. Trial Status: The study is ongoing at the NCI and 9 patients have been enrolled to date. Clinical trial information: NCT04943536 .
Gonadal Failure in a Male With 3-M Syndrome
Authors: Aldhoon-Hainerova Irena , Baranowski Elizabeth , Kinning Esther , Dias Renuka P 
Published: June 2024

Abstract
OMIM 273750 (3-M) syndrome is a rare cause of severe short stature with variable dysmorphic features caused by pathogenic variants in several genes including cullin7 gene (CUL7). Hypogonadism and hypospadias have been described in only a few males. We report a patient with CUL7 pathogenic variant who had bifid scrotum and perineal hypospadias at birth. He entered puberty spontaneously at age 12 years and appropriately completed pubertal development by 15 years. Subsequently, a regression of testicular volumes, increased gonadotropin levels, and reduced (although normal) testosterone levels were observed. This case highlights the importance of careful pubertal monitoring as pubertal dysfunction may be associated with 3-M syndrome.
Xiqu 2.0
Authors: Ferrari Rossella 
Published: June 2024

Abstract
Xiqu 2.0 designates an experimental approach to adapting and updating the classical theaters of the Sinophone region (xiqu) and a form of expanded Chinese opera in digital times. It highlights strategies of versioning and serialization of classical texts and tropes in (post-)modern performance environments and foregrounds media and textual interactivity, networking, and participatory contexts of production, reception, and circulation—including the production, reception, and circulation of cultural memory in the contemporary Sinosphere. The stage practice of Hong Kong–based multi-genre artist Danny Yung of Zuni Icosahedron and his long-term work with Tang Xianzu's Peony Pavilion (1598) illustrate the multiple dimensions of xiqu 2.0. Representative productions include the digital Kun opera Sigmund Freud in Search of Chinese Matter and Mind (2002, 2016) and the series The Interrupted Dream, launched in 2018. The latter links Tang's oneiric imaginary to the postcolonial critique of orientalism through references to seventeenth-century chinoiserie at the court of Louis XIV. Updated for livestreaming during the COVID-19 pandemic, the series served as a virtual channel of mediated memory across the digital Sinosphere in the aftermath of the 2019–20 Hong Kong protests and as a commentary on ancien and modern regimes, past and present revolutions, old and new Chinese dreams.
Effects of neuromuscular taping form I on wound temperature and erythema in diabetic foot ulcer: a preliminary study
Authors: Kristianto Heri , Ahsan Ahsan , Mukaroma Lailatul , Akhsinnadya Fenida , Indri Melati Cahyani , Damayanti Nina , Kusbandiyah Inne , Rohyani Ridha Tri , Blow David , Rias Yohanes Andy , Wibisono Ahmad Hasyim , Noviyanti Linda Wieke , Nasution Tina Handayani 
Published: June 2024

Objective: This study aimed to measure the effectiveness of neuromuscular taping (NMT) form I (a polyacrylate tape 0.6cm wide and 30cm long) on wound temperature and erythema in diabetic foot ulcers (DFUs) as an initial study in NMT intervention trials. Method: The study employed a quasi-experimental pretest and post-test design with a seven-day observation. The research sample was 38 patients with DFU grades 2 and 3. The sample was divided into two groups: the control group (n=19) and the intervention group (n=19). In wound care, the modern dressing was applied to both groups while NMT was applied to the intervention group in form I with 30cm long and 6mm wide strips, and on the proximal, distal and lateral sides. The wound bed temperature was measured with a non-contact infrared thermometer, and erythema was measured with Corel Photo-Paint X5 software (Corel Corp, Canada). Statistical analysis between the two groups was carried out using the Mann–Whitney test, independent t-test and Chi-squared test with p< 0.05 representing statistical significance. Results: The preliminary results revealed that no statistically significant differences (p>0.05) were noted between the groups in sociodemographic or clinical characteristics, including age, body mass index, blood sugar, duration of diabetes, sex, smoking history, wound temperature and degree of erythema. Finally, it was also observed that, after seven days of application, NMT form I increased wound bed temperature, and reduced the level of erythema (p<0.05). Conclusion: In this study, NMT form I has been shown to increase the wound bed temperature and reduce the degree of erythema in DFUs.
Non-lactational mastitis with multiple sinus wounds treated by integrated traditional Chinese and Western medicine
Authors: Zhang Yinhua , Zhang Ranran , Sun Chunlei , Meng Dong , Chen Ling 
Published: June 2024

Objective:Non-lactational mastitis (NLM) is a benign inflammatory disease of the mammary gland, with pain, swelling and redness as the main clinical manifestations. There is no unified and effective standard treatment plan for this disease at present. In addition to breast cancer, non-lactational mastitis is also becoming a presenting complaint in an increasing number of outpatients at the authors' clinic. This case report summarises the treatment and management of a 35-year-old female patient with NLM complicated with multiple sinus wounds after surgery.Method:The patient was treated as follows, with: timely debridement according to the local condition of the wound, with manual compression to drain exudate from the sinus wound; selected wound dressings according to their performance and characteristics to fill the sinus tract for drainage and infection control; psychological care of the patient and their family to ensure that patients actively participate in the treatment; family support to the patient to deal with negative emotions; integrated traditional Chinese and Western medicine to prevent/manage infection; dietary care and control; posture management and health education to facilitate the patient's wound healing process.Results:After local management with systemic treatment and management using integrated traditional Chinese and Western medicine, the wound healed after 46 days, with no recurrence during a follow-up period of one year.Conclusion:As shown in this case report, the wound should be cut and drained as soon as possible in order to prevent obstruction of the sinus drainage. Modern wound dressings are selected for the ‘external’ treatment of local wounds. Integrated traditional Chinese and Western medicine may help in systemic therapy of the whole patient.
Versatile, fast, and accurate frequency excursions with a semiconductor laser
Authors: Llauze Thomas , Montjovet-Basset Félix , Louchet-Chauvet Anne 
Published: June 2024

Achieving accurate arbitrary frequency excursions with a laser can
be quite a technical
challenge, especially when steep slopes
(GHz/µs) are required, due to
both deterministic and stochastic frequency fluctuations. In this work
we present a multistage correction combining four techniques:
pre-distorsion of the laser modulation, iterative correction,
opto-electronic feedback loop, and feed-forward correction. This
combination allows us not only to compensate for the non-instantaneous
response of the laser to an input modulation but also to correct in
real time the stochastic frequency fluctuations. We implement this
multistage architecture on a commercial DBR laser and verify its
efficiency, first, with monochromatic operation, and second, with
highly demanding frequency excursions. We demonstrate that our
multistage correction not only enables a strong reduction of the laser
linewidth but also allows steep frequency excursions with a relative
RMS frequency error well below 1% and a laser spectral purity
consistently better than 100 kHz, even in the midst of
gigahertz-scale frequency excursions.
Design and implementation of a physical layer optical fiber security communication system based on a ZUC stream cipher
Authors: Hui Shihao , Wang Dongfei , Wang Xiangqing , Li Zichen 
Published: June 2024

In this work, we have proposed a new physical layer encryption scheme to improve the
security of optical fiber communication systems. The secrecy scheme is
based on disturbance of the data cluster under the ZUC algorithm
(named for Zu Chongzhi, a famous mathematician in ancient China),
which is generated by optical XOR using a dual-drive Mach–Zehnder
modulator (DD-MZM). A base scrambling pseudo random binary sequence
(PRBS) generated by the ZUC stream cipher is introduced, which results
in a better scrambling effect and randomness in the key stream of the
block encryption structure. A simulation setup conducted in an
encrypted transmission of the 64×64 grayscale image over 80 km of optical
fiber shows that the authorized user can successfully decrypt the
received signal, while the eavesdroppers cannot derive useful
information with a bit error rate (BER) at approximately 0.5. In the
simulation, after setting the delay compensation to 3.125 ps, a
correct signal with a Q-factor as high as 11.3642 and a BER as low as 3.14295−30 can be obtained.