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    Olaparib monotherapy in advanced triple-negative breast cancer patients with homologous recombination deficiency and without germline mutations in BRCA1/2: The NOBROLA phase 2 study.

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    20.500.12530/87912To evaluate olaparib in advanced triple negative breast cancer (TNBC) patients with homologous recombination deficiency (HRD) and no germline BRCA1/2 mutations (gBRCA1/2mut). NOBROLA (NCT03367689) is a single-arm, open-label, multicenter, phase IIa trial, enrolling adult patients with advanced TNBC without gBRCA1/2mut and with HRD, who were treated with olaparib. The primary endpoint was clinical benefit rate (CBR) per RECIST v.1.1. Six of 114 patients were eligible and received olaparib. Median follow up was 8.5 months. CBR and overall response rate (ORR) were 50 % (95 % CI, 11.8-88.2). The observed results could prompt further investigation. ClinicalTrials.gov identifier NCT03367689

    Strategies for prevention and treatment of SARS-COV-2 infection in patients with chronic kidney disease: Literature review.

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    20.500.12530/87912COVID-19 has proven to be particularly aggressive in patients with chronic kidney disease (CKD). The lower immune response rate and the greater susceptibility to progress to severe forms of the disease have contributed to this phenomenon, which has persisted in the post-vaccination era of the pandemic. Paradoxically, CKD has been excluded from most clinical trials of the main therapeutic tools developed against SARS-CoV-2. However, experience in the use of these drugs has been accumulating in different stages of CKD, supporting their use with guarantees of efficacy and safety. The objective of this review is to gather all treatment indications for COVID-19 in the different phases of the disease, tailored to CKD in its various stages, including renal replacement therapy

    Custom CAD/CAM Peek Implants for Complex Orbitocranial Reconstruction: Our Experience with 15 Patients

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    20.500.12530/87909Bone defects within the cranio-orbital complex present unique challenges in terms of surgical planning and reconstruction. This article presents a novel approach using PEEK material and advanced surgical technologies to address these challenges. A retrospective analysis of 15 patients who underwent craniofacial reconstruction using patient-specific polyetheretherketone (PEEK) implants between 2016 and 2021 was carried out. Comprehensive preoperative planning was performed, utilizing advanced imaging techniques and specialized software for virtual surgical planning. Patient-specific PEEK PSIs were designed and manufactured based on the preoperative plan. Intraoperative navigation was used to guide the surgical procedure, enabling precise osteotomy and optimal implant placement. This article describes the step-by-step process and the tools utilized in each phase. The etiologies were as follows: meningioma in seven cases, benign lesions in five cases, malignant tumors in two cases, and trauma sequelae in one case. In all cases, 3D-printed PEEK implants were utilized to achieve precise reconstruction. No major complications were described. In one case, an implant replacement was needed with successful outcomes. Our study demonstrates the feasibility and effectiveness of using PEEK patient-specific implants for personalized craniofacial reconstruction. The combination of advanced imaging, virtual planning, and CAD-CAM technology contributes to improved surgical outcomes in terms of oncologic margin control, functional restoration, and aesthetic results

    Assisting medical decision in the diagnosis, treatment, and follow-up of vascular etiology ulcers using a mobile app

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    Introduction and objective: decision support systems (DSS) are computer systems that use computer devices or smartphones, facilitating the diagnosis and properly treatment of multiple pathologies, transforming health care into a dynamic, preventive and precision system. Vascular ulcers represent an important health problem, with great consumption of resources. Digital transformation can improve the quality of diagnoses, treatments and patient follow-up, and therefore improve the effectiveness and efficiency of healthcare. This paper aims to develop UlcerApp, a totally new mobile DSS for vascular ulcers management, which facilitates the diagnosis, treatment and monitoring of ulcers of vascular etiology, in the primary health care. Methods: for achieving the main purpose of this research work, a decision algorithm will be developed and implemented by an Android (Android Studio- JAVA) and iOS (XCode- Switf) mobile applications. Results: the App developed which implements the algorithms UlcerApp is capable of diagnose 6 kind of vascular ulcers: neuropathic, ischemic, neuroischemic, venous ulcer, mixed ulcer and hypertensive or Martorell ulcer. UlcerAPP is a visual and intuitive application that will guide the user to correct diagnosis. After them, users will be able to access the specific treatment. It will include follow-up recommendations as well as referral criteria. Conclusions: UlcerAPP is a project developed to improve the clinical management of vascular ulcers in the primary health care, enhance knowledge of vascular pathology and treatment of ulcers of said etiology

    Young age and adequate BCG are key factors for optimal BCG treatment efficacy in non-muscle-invasive bladder cancer.

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    To investigate the impact of ageing on survival outcomes in Bacillus Calmette-Guérin (BCG) treated non-muscle invasive bladder cancer (NMIBC) patients and its synergy with adequate BCG treatment. Patients with NMIBC who received BCG treatment from 2001 to 2020 were divided into group 1 ( 70 years). Overall Survival (OS), Cancer-Specific Survival (CSS), Recurrence-Free Survival (RFS), and Progression-Free Survival (PFS) were analyzed using the Kaplan-Meier method. Multivariable Cox regression analysis was used to adjust potential confounding factors and to estimate Hazard Ratio (HR) and 95% Confidence Interval (CI). Subgroup analysis was performed according to adequate versus inadequate BCG treatment. Overall, 2602 NMIBC patients were included: 1051 (40.4%) and 1551 (59.6%) in groups 1 and 2, respectively. At median follow-up of 11.0 years, group 1 ( 70 years). At subgroup analysis, patients in group 1 treated with adequate BCG showed better OS, CSS, RFS, and PFS as compared with inadequate BCG treatment in group 2, while patients in group 2 receiving adequate BCG treatment had 41% less progression than those treated with inadequate BCG from the same group. Being younger ( 70 years) who received adequate BCG treatment had similar PFS as those younger with adequate BCG treatment

    High pre-Delta and early-Omicron SARS-CoV-2 seroprevalence detected in dried blood samples from Kinshasa (D.R. Congo).

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    20.500.12530/87908Studies on the impact of the COVID-19 pandemic in sub-Saharan Africa have yielded varying results, although authors universally agree the real burden surpasses reported cases. The primary objective of this study was to determine SARS-CoV-2 seroprevalence among patients attending Monkole Hospital in Kinshasa (D.R. Congo). The secondary objective was to evaluate the analytic performance of two chemiluminescence platforms: Elecsys® (Roche) and VirClia® (Vircell) on dried blood spot samples (DBS). The study population (N = 373) was recruited in two stages: a mid-2021 blood donor cohort (15.5% women) and a mid-2022 women cohort. Crude global seroprevalence was 61% (53.9%-67.8%) pre-Delta in 2021 and 90.2% (84.7%-94.2%) post-Omicron in 2022. Anti-spike (S) antibody levels significantly increased from 53.1 (31.8-131.3) U/mL in 2021 to 436.5 (219.3-950.5) U/mL in 2022 and were significantly higher above 45 years old in the 2022 population. Both platforms showed good analytic performance on DBS samples: sensitivity was 96.8% for IgG (antiN/S) (93.9%-98.5%) and 96.0% (93.0%-98.0%) for anti-S quantification. These results provide additional support for the notion that exposure to SARS-CoV-2 is more widespread than indicated by case-based surveillance and will be able to guide the pandemic response and strategy moving forward. Likewise, this study contributes evidence to the reliability of DBS as a tool for serological testing and diagnosis in resource-limited settings

    Real-world experience with CDK4-6 inhibition in the old and oldest old with a diagnosis of breast cancer.

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    20.500.12530/87908This study describes characteristics, toxicity and survival in old patients with HR+/HER2-breast cancer (BC) treated with CDK4/6 inhibitors. Retrospective observational study that included patients ≥ 75 years with HR+/HER2-BC treated with CDK4/6 inhibitors between 2017 and 2021. Patients' general and cancer-related data were collected. Comprehensive Geriatric Assessment scales were gathered. Adverse events reported before each cycle were included. At the end of the follow-up period, mortality was retrospectively registered from medical records. All 19 patients (94.7% women, median age 77.9 ± 10.1) were at risk of frailty (G8 ≤ 14) and malnutrition (MNA-SF ≤ 11). Most were independent (52.7% Lawton ≥ 6), had no cognitive impairment (89.5%, MMSE ≥ 24), poor physical performance (70%, SPP

    Predictive Factors of Functional Outcomes and Quality of Life in Patients with Ankle Fractures: A Systematic Review.

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    20.500.12530/87908Background: Evaluating the predictors of unfavorable outcomes in patients with ankle fractures is crucial for identifying high-risk patients and implementing personalized treatment strategies. This study aimed to analyze factors that influence quality of life in patients with ankle fractures. Methods: Four databases were consulted. The main outcomes were functionality and quality of life scales combined using the standard mean difference (SMD) (Review Manager 5.4). Results: Eight studies with 2486 patients were included. A significant correlation was found between female sex and worse functionality scores (beta 4.15, 95% CI 1.84-6.46). Additionally, older age was correlated with worse functionality scores (beta -0.24, 95% CI -0.29 to -0.19). Patients with diabetes or metabolic syndrome also had worse outcomes (SMD 0.27, 95% CI 0.18-0.36). High BMI and obesity were also associated with worse quality of life scores (beta 2.62, 95% CI 0.77-4.48). Smokers had greater disability in the analyzed scales (SMD 0.22, 95% CI 0.05-0.39). No significant differences were observed with respect to syndesmotic involvement. Conclusions: Age, sex, diabetes, high BMI, and smoking negatively impact functional outcomes and quality of life in patients with ankle fractures

    Intraoperative liquid biopsy as a tool for detecting R1 resection during pancreatoduodenectomy in patients with pancreatic carcinoma: the CETUPANC trial (part II).

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    A positive surgical margin (R1 resection) is a relevant risk factor for local recurrence in patients with pancreatic ductal adenocarcinoma of the pancreas (PDAC). An intraoperative liquid biopsy (ILB) based on tumor cell mobilization could help to detect R1 resection intraoperatively. To evaluate the potential role of the intraoperative circulating tumor cells (CTCs) and cluster mobilization on the R0/R1 detection. Sixty-three patients with resectable PDAC of the head of the pancreas were prospective enrolled under the CETUPANC trial. Open pancreaticoduodenectomy (PD) was done in all patients. Intraoperative CTCs and clusters were determined during PD. The overall rate of R1 resection was 34.9% (22/63 patients). Multivariate analysis showed that factors associated with R1 resection (AUC=0.920) were the presence of undifferentiated G3 tumor (P=0.017), microscopic vascular invasion (P=0.016), and the intraoperative increase of both free CTCs and clusters in portal vein determination from the beginning to the end of the surgery (P=0.002 and P=0.005, respectively). A specific logistic regression model, including delta end to baseline CTCs and cluster mobilization to achieve a combined cut-off to detect R1 detection was calculated (AUC=0.799). The obtained R1-index based on ILB had 84% of sensitivity and 68% of specificity to detect R1 resection. The ILB based on the intraoperative mobilization of CTCs and clusters from the beginning to the end of the PD was a predictive factor to detect R1 resection in patients with PDAC

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