bluuebunny/crossref_metadata_2025_split huggingface dataset:
Level of insight in Egyptian patients having obsessive compulsive disorder: a comparative study
Authors: Abdelmoneam Mohamed Hossam el din , Elbatrawy Amira Nassieb , Khalil Sherien Ahmed , Shalaby Riham Ahmad , Ali Moatazbellah Ibrahim 
Published: June 2024

Abstract
Background and objectives
Obsessive–compulsive disorder (OCD) is a chronic psychiatric disorder defined by the existence of obsessions and/or compulsive behaviors or mental acts persistently and affects around 1–3% of the population in the world. Multiple studies demonstrated the link of the insight level to how severe was OCD and existence of resistance to both medications and psychotherapy in individuals with OCD. Studying the characteristics associated with poor insight is very important for management of treatment-resistant OCD and development of new therapeutic approaches. The purpose of this work was to assess the level of the insight in Egyptian patients with OCD, identify clinical correlates that could anticipate the degree of insight, and assess the validity and reliability of brown assessment of belief scale after being translated to Arabic version.

Methods
A comparative cross-sectional study of 96 individuals (male and female aged from 18 to 60) diagnosed with OCD based on the Arabic version of the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). The study excluded any individuals with any coexisting neuro-psychiatric conditions and a history of major medical disease. Severity of OCD was assessed through the Arabic version of the Yale–Brown Obsessive–Compulsive Scale (YBOCS). Subsequently, participants performed the Brown Assessment of Beliefs Scale (BABS) after being translated into Arabic and assessed for reliability, validity and applicability of the translated form.

Results
Patients with OCD presented with poor insight were associated with more untreated time interval, longer disease duration and more severity that was dramatically differed (p ≤ 0.05, ≤ 0.001, ≤ 0.05 respectively). Also, there was a substantial notable correlation among BABS and YBOCS obsession, compulsion, and total score.

Conclusions
The existence of good insight in patients diagnosed with OCD was associated with lower severity and less duration of illness compared to patients with poor insight. Also, the more time waited before the intervention the worst the patient scores on the insight scale.
The added value of positron emission mammography in the assessment of the axillary lymph nodes of the pathologically proven breast cancer
Authors: Hammad Ghada Fathy , Radwan Amira Hamed , Shetat Ola Magdy , Mohamed Ghada , Ebraheem Maher Hassan , Gomaa Mohamed Mohamed 
Published: June 2024

Abstract
Background
The staging and management of patients with breast cancer are significantly influenced by the pathological state of the axillary lymph nodes (ALN). Thus, it is very desirable to have a differential diagnosis of metastatic ALN.

Purpose
The aim of this research is to assess the effectiveness of non-invasive ALN staging using PEM versus traditional breast mammography and ultrasound in patients presenting with early-stage breast cancer. This study focuses on determining if PEM can reliably stage ALNs and potentially eliminate the need for more invasive methods.

Methods
In a study involving 94 breast cancer patients, PEM was used to assess ALNs. The nodes were visually evaluated for positive or negative uptake, and further categorized as non-specific, indeterminate, or malignant based on their maximum uptake values. This classification was then compared with histopathological results.

Results
There were a total of 94 breast cancer patients; the results from PEM demonstrated an ALN detection sensitivity of 83.3%. The specificity of PEM in this context was found to be 98.08%, and the overall accuracy rate was 91.49%. Additionally, the Positive Predictive Value (PPV) was calculated to be 97.2%, and the Negative Predictive Value (NPV) was 87.9%.

Conclusions
The initial study has shown encouraging outcomes in terms of accurate lymph node assessment.
Green analytical chemistry-based spectrophotometric techniques for ternary component analysis of pain relievers
Authors: Arunagiri Thirumalai , Ganesan Alagammai , Ravi Kumaran Vamsi , Masilamani Bharathraj , Kannaiah Kanaka Parvathi , Narayanasamy Damodharan 
Published: June 2024

Abstract
Background
The management of pain presents a significant challenge in healthcare, particularly in cases where conventional therapies prove inadequate. In response to this need, this study aims to devise two innovative UV spectrophotometric techniques rooted in the principles of green analytical chemistry for the analysis of Aceclofenac (ACE), Paracetamol (PAR), and Tramadol (TRM) in both bulk and tablet forms.

Results
Utilizing advanced mathematical methodologies such as the double divisor ratio spectra method and area under the curve, the concentrations of these drugs were accurately determined. Validation of the developed methods adhered to the guidelines outlined by the International Council for Harmonisation in the Q2 (R1), revealing linear calibration curves for ACE (8–12 µg/mL), PAR (22.75–35.75 µg/mL), and TRM (2.62–4.12 µg/mL). Furthermore, statistical analyses employing Student’s t test and F test were conducted to ensure the robustness of the proposed method. The evaluation of environmental impact through green metric tools confirmed the eco-friendliness of the proposed methodologies.

Conclusion
The assessment performed utilizing green metric tools has substantiated the environmental sustainability of the proposed approach. Thus, this methodology offers accurate and reliable outcomes for the determination of three drugs, as indicated by the complete overlap observed in the zero-order spectra.
[68Ga]Ga-ABY-025 PET in HER2-positive breast cancer: Benefits and pitfalls in staging of axillary disease.
Authors: Alhuseinalkhudhur Ali , Lindman Henrik , Liss Per , Frejd Fredrik Y. , Feldwisch Joachim , Brun Nikolai C. , Lubberink Mark , Velikyan Irina , Sörensen Jens 
Published: June 2024

1035 Background: [68Ga]Ga-ABY-025 PET showed promising results in quantifying human epidermal growth factor receptor Type 2 (HER2) expression in breast cancer patients [1]. In this study we extend the findings from [68Ga]Ga-ABY-025 PET with data from both treatment-naïve patients and previously treated patients with recurrences, mimicking the clinical situation other sites might encounter when HER2-targeting imaging is made more widely available. The focus of this additional data analysis is on staging, potential pitfalls and changes in uptake patterns associated with previous treatments. Methods: [68Ga]Ga-ABY-025 PET and [18F]-FDG PET images from 50 women with biopsy confirmed HER2 positive breast cancer were examined. Each patient underwent both scans within 1 week. A follow-up [18F]-FDG PET was performed after 2 courses of HER2-targeted treatment to assess metabolic response. Results: Twelve out of 50 patients showed heterogeneous [68Ga]Ga-ABY-025 uptake. Three out of these 12 patients presented with a wider local spread that was only detectable using [68Ga]Ga-ABY-025 PET as distinct uptake in lymph nodes of 2-5 mm size. Based on the additional information from [68Ga]Ga-ABY-025 PET, restaging was evaluated in two of the three cases, both of which had lobular carcinoma, and resulted in modifications in treatment plans. Two patients who received COVID-19 vaccine closely before undergoing PET scans showed high uptake on [18F]-FDG PET in lymph nodes ipsilateral to the vaccine injection site, but not on [68Ga]Ga-ABY-025 PET. Additionally, the physiological [68Ga]Ga-ABY-025 uptake in thyroid gland and axillary sweat glands was inversely correlated with the number of previous treatments and was significantly more pronounced in treatment-naïve patients. Conclusions: [68Ga]Ga-ABY-025 PET provided additional information that, in conjunction with [18F]-FDG PET findings, might help in accurate staging, particularly in cases with very small lymph node metastases. It also helped reduce false positive results as [68Ga]Ga-ABY-025 uptake was so far not seen in any benign inflammatory lesions. Physiological uptake can be seen in thyroid and apocrine glandular tissues but gradually disappear with subsequent HER2-targeted therapies. 1,Alhuseinalkhudhur, A. et al. J Nucl Med, 2023 64(9): p. 1364-1370. Clinical trial information: NCT03655353 .
Effects of immune-enhancing nutrition on radical cystectomy outcomes: Primary results from the randomized phase III double-blind clinical trial (S1600).
Authors: Hamilton-Reeves Jill , Unger Joseph M. , Holzbeierlein Jeffrey , Lew Danika , Mark James Ryan , Daneshmand Siamak , Kukreja Janet Baack , Lee Eugene K. , Tabayoyong William , Hershman Dawn L. , Fisch Michael Jordan , Henry Norah Lynn 
Published: June 2024

4501 Background: SWOG S1600 was a randomized, double-blind, phase III trial comparing the impact of consuming Specialized IMmunonutrition (SIM) to oral nutritional support (ONS) on postoperative complications following radical cystectomy (RC). SIM is fortified with nutrients: L-arginine; omega-3 fatty acids; and dietary nucleotides. Methods: Patients with bladder carcinoma planning to undergo RC were enrolled and randomized 1:1 to SIM vs. ONS. The primary endpoint was any (≥Grade I) postoperative complication assessed by the Clavien-Dindo (CD) scale at Day 30 after RC. Multivariable logistic regression was used, adjusted for the stratification factors: diversion type (neobladder vs. ileal conduit), prior neoadjuvant chemotherapy (any vs. none), and baseline nutrition status (well-nourished vs. moderate malnutrition). Additional outcomes included 90-day complications and high-grade (CD ≥Grade III) complications. Two-year progression-free survival (PFS) and overall survival (OS) were assessed; differences by arm were reported using Log-rank test statistics. Protocol-specified intention-to-treat (ITT) analyses based on all randomized patients and 1-sided alpha=.05 tests were performed. Results: Among N=203 enrolled patients (99 on SIM, 104 on ONS), median age was 68.8 years, 20% were female and 5% were Black. Five patients did not meet eligibility criteria (1 on SIM, 4 on ONS) but were included under the ITT design. Seventeen patients withdrew consent prior to their Day 30 assessment, and 8 patients were not assessed; thus, n=178 (90 on SIM, 88 on ONS) were evaluable at Day 30. The proportion of patients experiencing CD Grade ≥1 complications was 62.2% for SIM and 58.0% for ONS; in multivariable regression, there was no difference in Grade ≥1 complications by arm (OR=1.18, 95% CI, 0.64-2.18, 1-sided p=.71). There were no differences by arm in high-grade complications at Day 30, in any or high-grade complications at Day 90 or overall. To date, among all 203 patients, 17 on SIM and 26 on ONS have progressed or died, with 2-year PFS estimates of 77.2% and 68.3%, respectively (1-sided p=.16). Nine patients on SIM and 17 on ONS have died, with 2-year OS estimates of 87.4% and 78.2%, respectively (1-sided p=.07). Conclusions: There was no difference in any grade CD complications by type of nutritional supplement for patients with bladder cancer undergoing RC. Fewer patients on the SIM arm have progressed or died, although differences were not statistically significant; follow-up for survival will continue through 3-years after enrollment. Future work to understand the interaction of diet on cancers sensitive to immune modulation is needed. Clinical trial information: NCT03757949 .
Characterization of complete responders to nivolumab + gemcitabine-cisplatin vs gemcitabine-cisplatin alone and patients with lymph node–only metastatic urothelial carcinoma from the CheckMate 901 trial.
Authors: Galsky Matt D. , Sonpavde Guru P. , Powles Thomas , Claps Melanie , Burotto Mauricio , Schenker Michael , Sade Juan Pablo , Bamias Aristotelis , Beuzeboc Philippe , Bedke Jens , Oldenburg Jan , Ürün Yüksel , Ye Ding-Wei , Valderrama Begoña Pérez , Tomita Yoshihiko , Filian Jeiry , Wang Lily , Purcea Daniela , Van Der Heijden Michiel Simon 
Published: June 2024

4509 Background: In the CheckMate 901 trial, combination nivolumab (NIVO) + gemcitabine-cisplatin (GC) demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) with compelling objective response rates (ORR; 57.6% with NIVO+GC vs 43.1% with GC alone) and deep, durable complete responses (CR; 21.7% with NIVO+GC vs 11.8% with GC alone) in patients (pts) with previously untreated unresectable or metastatic urothelial carcinoma (mUC). Lymph node (LN)-only metastatic disease is a favorable prognostic factor in pts with mUC and a subset of pts achieve durable disease-free, treatment-free survival with GC +/- surgical consolidation. We conducted a post hoc analysis to characterize the subset of pts with CR, with further analysis of pts with LN-only mUC. Methods: In the global, open-label, randomized, phase 3 CheckMate 901 (NCT03036098) trial, cisplatin-eligible pts received NIVO 360 mg + GC every 3 wk for ≤6 cycles followed by NIVO 480 mg every 4 wk until disease progression/unacceptable toxicity or up to a maximum of 2 yrs, or GC every 3 wk for ≤6 cycles. Primary endpoints were OS and PFS by blinded independent central review (BICR). ORR per BICR and safety were exploratory endpoints. These post hoc analyses evaluated treatment outcomes in complete responders and in pts with LN-only disease. Results: Of the 608 pts randomized, 102 (16.8%) achieved a CR. Baseline disease characteristics of these pts are shown in the Table. As pts with LN-only mUC were enriched in the CR group, additional analysis of this subgroup was performed. Of all randomized pts, 54 treated with NIVO+GC and 56 treated with GC had LN-only mUC. In these pts, the ORR and CR rate was 81.5% (95% CI 68.6-90.7) and 63.0% versus 64.3% (50.4-76.6%) and 33.9% for NIVO+GC and GC, respectively. Median OS (95% CI) in LN-only pts was 46.3 (24.0-NE) mos with NIVO+GC vs 24.9 (21.4-29.9) with GC (HR, 0.58, 95% CI 0.34-1.00), and median PFS (95% CI) was 30.5 (9.6-NE) mos with NIVO+GC vs 8.8 (7.5-10.9) mos with GC (HR 0.38, 95% CI 0.22-0.66). Conclusions: NIVO+GC generated deep responses in CheckMate 901 with a fixed duration of chemotherapy and up to 2 years NIVO. Exploratory characterization of pts with CR identified a group of pts enriched with LN-only disease.In pts with LN-only mUC, NIVO+GC induced durable disease control and clinically meaningful improvements in OS and PFS vs GC alone. These results provide additional support for NIVO plus cisplatin-based chemo as a first-line treatment option for pts with mUC. Clinical trial information: NCT03036098 . [Table: see text]
A multicenter phase II study of modified FOLFIRINOX for first-line treatment for advanced urachal cancer (ULTMA; KCSG GU20-03).
Authors: Lee Jae-Lyun , Park Inkeun , Yoon Shinkyo , Shin Sang Joon , Shin Seong-Hoon , Park Kwonoh , Kim Jung Hoon , Lee Hyo Jin 
Published: June 2024

4510 Background: Systemic therapy is used for advanced urachal cancer that is not amenable to surgery. However, due to the low incidence of this disease, prospective clinical trials have not been conducted and there is no established standard of care. 5-FU, oxaliplatin, and irinotecan have synergistic mechanisms of action, do not overlap in major side effects, and all have the potential to be effective in urachal cancer. The ongoing ULTIMA trial (NCT04611724) is evaluating the efficacy and safety of modified FOLFIRINOX in patients with advanced urachal cancer. Methods: Patients with recurrent or metastatic urachal cancer with measurable lesions received modified FOLFIRINOX (Oxaliplatin 85 mg/m2 over 2 hours, Irinotecan 150 mg/m2 over 1.5 hours, Leucovorin 400 mg/m2 over 2 hours and 5-FU 2400 mg/m2 over 46 hours) with prophylactic pegteograstim 6 mg SC on day 3 Q2W till 12 cycles (or until progression or unacceptable toxicities). Response evaluation was done every 6 weeks. The primary endpoint is an ORR. The secondary objectives include PFS, OS and incidence of febrile neutropenia. Simon’s minimax two-stage design was employed to test null hypothesis P0=17% and P1=36%, with alpha of 5% and beta of 20%. The primary endpoint was met at the first stage and we decided to report the results. Results: From April 2021 to November 2023, 21 patients with advanced urachal cancer were enrolled in 5 cancer centers. A median age was 50 (28-68) and 15 were male. Lung was the most frequent site of metastasis (47.6%) followed by lymph node (38.1%) and peritoneal seeding (33.3%). As of December 2023, 18 patients discontinued treatment. A total of 235 cycles were administered with a median of 12 (6-12) cycles per patient. Two patients achieved CR and 11 patients PR with an ORR of 61.9%; the study met the primary endpoint in the first stage. With a median FU duration of 15.2 months, the median PFS was 9.3 months (95% CI, 6.6~12.0) and estimated median OS was 26.4 months (95% CI, 14.7-38.1). The treatment was tolerable and have no unexpected adverse events. Grade 3 adverse events included neutropenia (4.8%), anemia (9.5%), thrombocytopenia (4.8%) and diarrhea (4.8%). There were neither febrile neutropenia nor grade 4 adverse events. Conclusions: The first prospective ULTIMA study showed encouraging ORR and PFS in patients with advanced urachal cancer. The regimen is well tolerated without febrile neutropenia with prophylactic pegteograstim. Further analysis of efficacy will be presented. Clinical trial information: NCT04611724 .
A phase 1 study of JNJ-69086420 (JNJ-6420), an actinium-225 (225Ac) -labeled antibody targeting human kallikrein 2 (hK2), for metastatic castration-resistant prostate cancer (mCRPC).
Authors: Morris Michael J. , Wong Jeffrey Y.C. , Nordquist Luke , Szmulewitz Russell Zelig , Agarwal Neeraj , Attiyeh Edward F. , Max Steven I , Divgi Chaitanya R. , Patricia Daniel , Cao Yu , Li Xiang , Yu Alex , Urtishak Karen , Lauring Josh David , Sartor Oliver 
Published: June 2024

5010 Background: hK2 (encoded by the KLK2gene) is a novel target expressed on the cell surface of prostate cancer cells with restricted expression elsewhere. JNJ-6420 is a first-in-class anti-hK2 antibody–based targeted radiotherapy delivering 225Ac, a high-energy short-range alpha-particle emitter, to prostate cancer cells. Here we report the first-in-human study evaluating JNJ-6420 in heavily pretreated biomarker-unselected participants (pts) with mCRPC who received ≥1 prior androgen receptor pathway inhibitor. Methods: Intravenous JNJ-6420 was escalated from 50 μCi to 400 μCi every 8-12 weeks in the outpatient setting with no residential radioprotective restrictions. Prior radioisotopic therapy was an exclusion criterion. Primary objectives were safety and defining a recommended phase 2 dose (RP2D). Secondary objectives included preliminary assessment of clinical activity. Results: As of January 5, 2024, 67 pts received ≥1 JNJ-6420 dose. Exposure and clinical activity for the 57 pts in the ≥150 μCi JNJ-6420 cohorts are summarized (see Table); 35/57 (61.4%) experienced grade ≥3 TEAEs, and 21 (36.8%) had a serious TEAE. TEAEs of note included thrombocytopenia (63.2%) and interstitial lung disease (ILD, 9%). All instances of ILD occurred at cumulative doses ≥500 μCi and prior to implementation of pulmonary function surveillance. Grade ≥3 TEAEs (≥10%) included anemia (26.3%), thrombocytopenia (17.5%), lymphopenia (10.5%), and leukopenia (10.5%). 9/57 (15.8%) pts discontinued treatment due to TRAEs; 4 TRAEs resulted in death. At doses ≥150 μCi, the PSA50 rate was 45.6%. To date, across all dose cohorts, 31 pts (46%) remained on treatment for ≥24 weeks. Prolonged clinical, biochemical, and radiographic responses were noted in pts receiving doses of 150 μCi and higher. Durable responses included pts on treatment for 112 weeks (96 weeks since last dose), 88 weeks (13 weeks since last dose), and 46 weeks (after a single dose). Conclusions: In this first-in-human study, key TEAEs of JNJ-6420 were thrombocytopenia and ILD, both associated with repeated dosing. At ≥150 μCi, 1-2 doses of JNJ-6420 elicited profound and durable biochemical and radiographic responses. Evaluation of the RP2D is ongoing. These data highlight hK2 as a novel target for targeted alpha-particle therapy. Clinical trial information: NCT04644770 . [Table: see text]
Oncogenic alteration rates, race, and prostate cancer specific mortality in Veterans with metastatic prostate cancer undergoing somatic tumor next generation sequencing.
Authors: Valle Luca Faustino , Li Jiannong , Desai Heena , Hausler Ryan , Haroldsen Candace , Kelley Michael J. , Rebbeck Timothy , Rose Brent S. , Rettig Matthew , Nickols Nicholas George , Garraway Isla , Yamoah Kosj , Maxwell Kara Noelle 
Published: June 2024

5017 Background: National guidelines recommend next generation sequencing (NGS) of tumors from patients diagnosed with metastatic prostate cancer (PCa) to identify potential actionable alterations. We sought to determine associations between alteration frequencies of PCa-related genes and pathways, self-identified race, and PCa specific mortality (PCSM) in Veterans. Methods: This comprehensive retrospective cohort study evaluated the association of somatic alterations with race in Veterans with metastatic PCa who obtained NGS through the Veterans Affairs National Precision Oncology Program. NGS data was linked to clinicopathologic and social determinants of health (SDOH) data elements. Multivariate logistic regression permitted associations between race and genomic alteration frequencies, adjusted for specimen tested and clinical and SDOH co-variates. Cox proportional hazards models permitted associations of race, alteration frequencies, and PCSM, stratified by genomic alteration frequencies and adjusting for race, clinicopathologic features, and SDOH. Results: 5015 Veterans with metastatic PCa and self-identified race/ethnicity as non-Hispanic Black (NHB, n=1784) and non-Hispanic White (NHW, n= 3231) were included. NGS was conducted on primary tumors (n= 2359), metastases (n = 1011), and cfDNA (n = 1644). NHB Veterans were younger, had higher PSA at PCa diagnoses, were less likely to report Agent Orange exposure, and resided in more deprived neighborhoods. Upon adjusting for tissue sequenced and clinicopathologic variables, NHB race/ethnicity was significantly associated with a higher rate of genomic alterations in immunotherapy targets, SPOP and BRAF(p<0.05 for all) .Furthermore , NHB race/ethnicity was significantly associated with lower rates of genomic alterations in the AKT/PI3K pathway, AR axis ,and tumor suppressor genes including TP53and PTEN(p<0.05 for all). While alterations in TP53 (HR 1.5 [1.1-2.0], p=0.007), and tumor suppressor pathways (HR 1.3 [1.0-1.8], p=0.04) conferred a significantly higher risk of PCSM in all men on adjusted analysis, race was not independently associated with PCSM. Conclusions: In this diverse cohort of Veterans undergoing NGS for metastatic PCa in the equal access VA healthcare system, we observed significant differences in alteration rates of several oncogenic genes/pathways by race. While alterations in tumor suppressor genes were significantly associated with PCSM, race was not. Thus, there remains a critical need for integrating personalized approaches to patient selection for metastatic PCa treatments in order to improve disease-specific outcomes across diverse populations.