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The BALTO Registry: Long-term results of percutaneous BALloon pericardioTomy in oncological patients.
No full textThe aim of this study was to analyze the efficacy and safety of percutaneous balloon pericardiotomy (PBP) in oncological patients who present with a malignant pericardial effusion (MPE). The use of PBP as a treatment for MPE is not standardized due to the limited evidence. Furthermore, the performance of a second PBP for a recurrence after a first procedure is controversial. The BALTO Registry (BALloon pericardioTomy in Oncological patients) is a prospective, single-center, observational registry that includes consecutive PBP performed for MPE from October 2007 to February 2022. Clinical and procedural, characteristics, as well as clinical outcome were analyzed. Seventy-six PBP were performed in 61 patients (65% female). Mean age was of 66.4 ± 11.2 years. In 15 cases, a second PBP procedure was performed due to recurrence despite the first PBP. The procedure could be performed effectively in all cases with only two serious complications. Ninety-five percent of cases were discharged alive from the hospital. During a median follow-up of 6.3 months (interquartile range [IQR], 0.9-10.8), MPE recurred in 24.5% cases although no recurrences were reported after the second procedure. No evidence of malignant pleural effusion developed on follow-up. The median overall survival time was 5.8 months (IQR, 0.8-10.2) and the time to recurrence after the first PBP was 2.4 months (IQR, 0.7-4.5). PBP is a safe and effective treatment for MPE. It could be considered an acceptable therapy in most MPE, even in those who recur after a first procedure
Laparoscopic ovarian tissue collection for fertility preservation in children with malignancies: a multicentric experience.
No full text20.500.12530/87858Long survivors after childhood cancer are increasing thanks to oncological improvements. Their quality of life and fertility-sparing should be considered in the early phases of each oncological pathway. Cryopreservation of ovarian tissue removed before starting gonadotoxic therapies is the only fertility sparing procedure available for prepubertal children affected by cancer and it does not affect the timing of the start of the treatment. The present study shows the surgical and clinical outcomes following laparoscopic ovarian tissue collection (LOTC) for a total of 311 patients aged between 0 and 17 years old from four different European Centers. Only two major complications were reported according to the Clavien Dindo classification (0.6%). LOTC can be considered a safe procedure
Neurological manifestations of immune origin after COVID-19 vaccination: retrospective case study.
No full text20.500.12530/87857Objectives: To know the frequency and characteristics of neurological manifestations of probable immune origin occurring after exposure to COVID-19 vaccination. In addition, to pre-study the usefulness of the Spanish pharmacovigilance system and lymphocyte transformation test in establishing causality. Methods: Retrospective case study, including patients admitted to the Neurology department from January 2021 to May 2022 with a probable neuroimmune disorder. Demographic, clinical and COVID-19 vaccination antecedent data were collected from medical records. Results: From a total of 108 patients, 30 were excluded due to a different etiological diagnosis after follow-up. Thirty-six patients (46.2%) had received the COVID-19 vaccine in the previous 3 months (21.8% during the previous month). BioNTech-Pfizer vaccine was the most frequent in this group (63.9%). 69/108 were female and mean age 51.2 years (SD 22.59), with no significant difference with not recently-vaccinated (U-Mann Whitney, p = 0.256). The neurological syndromes found were (vaccinated/total): polyradiculoneuropathy (8/16), encephalitis (5/11), multiple sclerosis relapse (5/16), optic neuritis (1/4), myelitis (3/6), cranial neuropathy (6/10), aseptic meningitis (1/3) and others (7/11). Acute immunosuppressive treatment was administered in 61.1% of cases and 47.2% presented complete clinical improvement, without significant differences with non-vaccinated patients (chi-square, p = 0.570). Eleven vaccinated patients were studied in the pharmacovigilance office for possible adverse drug reaction. Causality according to the Spanish pharmacovigilance system (SPVS) algorithm was "Related" to COVID-19 vaccine (score ≥ 4) in 11 cases with positive in vitro study (lymphocyte transformation test) to polyethylene glycol-2000 and polysorbate-80 in 4 cases. Conclusion: Neuroimmune disorders appearing after administration of COVID-19 vaccine do not seem to present important differentiating clinical and/or evolutive features. Delayed hypersensitivity to vaccine excipients could be one of the pathophysiological mechanisms, and lymphocyte transformation test is a useful tool to identify it
Synthesis, antioxidant and neuroprotective analysis of diversely functionalized α-aryl-N-alkyl nitrones as potential agents for ischemic stroke therapy.
No full text20.500.12530/87854Herein, we report the synthesis, antioxidant and biological evaluation of 32 monosubstituted α-arylnitrones derived from α-phenyl-tert-butyl nitrone (PBN) in the search for neuroprotective compounds for ischemic stroke therapy, trying to elucidate the structural patterns responsible for their neuroprotective activity. Not surprisingly, the N-tert-butyl moiety plays beneficious role in comparison to other differently N-substituted nitrone groups. It seems that electron donor substituents at the ortho position and electron withdrawing substituents at the meta position of the aryl ring induce good neuroprotective activity. As a result, (Z)-N-tert-butyl-1-(2-hydroxyphenyl)methanimine oxide (21a) and (Z)-N-tert-butyl-1-(2-(prop-2-yn-1-yloxy)phenyl)methanimine oxide (24a) showed a significant increase in neuronal viability in an experimental ischemia model in primary neuronal cultures, and induced neuroprotection and improved neurodeficit score in an in vivo model of transient cerebral ischemia. These results showed that nitrones 21a and 24a are new effective small and readily available antioxidants, and suitable candidates for further structure optimization in the search for new phenyl-derived nitrones for the treatment of ischemic stroke and related diseases
First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug.
No full textThe clinical candidate alpibectir augments the activity of, and overcomes resistance to, the anti-TB drug ethionamide in vitro and in vivo. A Phase 1, double-blind, randomized, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK) and food effect of alpibectir administered as single and multiple oral doses in healthy volunteers (NCT04654143). Eighty participants were randomized. In single ascending dose (SAD), a total of six dose levels of alpibectir (0.5 to 40 mg) were tested under fasted and fed (10 mg) conditions as single daily doses in sequential cohorts. In multiple ascending dose (MAD), repeat doses (5 to 30 mg) were administered once daily for 7 days in three sequential cohorts. No serious adverse event was reported. Thirteen participants across groups experienced a total of 13 mild or moderate treatment-emergent adverse events. Alpibectir showed rapid absorption after single dose (mean Tmax range of 0.88 to 1.53 h). Food affected the PK of alpibectir, characterized by a slower absorption (mean Tmax 3.87 h), a lower Cmax (-17.7%) and increased AUC0-t (+19.6%) compared with the fasted condition. Following repeat dosing, dose proportionality was shown for both Cmax and AUC0-tau. Accumulation of alpibectir was observed across all doses, with a more profound effect on AUC during a dosing interval (AUC0-tau) compared with Cmax (1.8- and 1.3-fold on average), respectively. Steady state was considered to have been achieved by Day 7 of dosing. Alpibectir was generally well tolerated, and no clinically relevant safety findings were identified in the participants treated during SAD or MAD. The PK is dose-proportional and affected by food
Proximal Medial Gastrocnemius Recession for Recalcitrant Plantar Fasciitis.
No full text20.500.12530/87897Recalcitrant plantar fasciitis (RPF) is characterized by its unresponsiveness to conservative treatments, and its surgical management remains controversial. Although there is some evidence to suggest that gastrocnemius recession can be an effective treatment for RPF, no large series of patients with mid- to long-term follow-up has been published. The objective of this study was to compare physical performance, as measured by the Foot and Ankle Ability Measure activities of daily living score (FAAM-ADL), and pain levels before and 1 year after undergoing proximal medial gastrocnemius recession (PMGR) as a treatment for RPF. Additionally, we aimed to assess this cohort of patients in the mid- to long-term follow-up. This retrospective cohort study included 167 patients who underwent PMGR to address RPF between 2009 and 2021. Patients were examined with the FAAM ADL, visual analog scale (VAS) and satisfaction scores at baseline, 1 year, and at the end of follow-up. Other variables recorded were weight, duration of symptoms until surgery, time between surgery to substantial clinical improvement, calf power and Silfverskiold test, and postoperative complications. We observed that before surgery patients had an FAAM-ADL score of 22.5 (SD 11.1) and a VAS score of 8.6 (SD 9.3). One year after surgery, patients had an FAAM-ADL score of 89 (SD 17) and VAS of 1.33 (SD 2) (P 12.5 years) group had a median of 86.4 (SD 22.6), the VAS score was 1.90 (SD 2.84), and the patient satisfaction score had a median of 1 (interquartile range 0-1). Regarding complications, we observed 1 lateral gastrocnemius recession and 1 sural nerve neuritis. Our study provides substantial evidence supporting the use of PMGR as an effective treatment for RPF. The long-term follow-up and large sample size of our series contribute to the existing literature on this topic
Real-World Impact of Upfront Cytoreductive Nephrectomy in Metastatic Non-Clear Cell Renal Cell Carcinoma Treated with First-Line Immunotherapy Combinations or Tyrosine Kinase Inhibitors (A Sub-Analysis from the ARON-1 Retrospective Study).
No full text20.500.12530/87854About 20% of patients with renal cell carcinoma present with non-clear cell histology (nccRCC), encompassing various histological types. While surgery remains pivotal for localized-stage nccRCC, the role of cytoreductive nephrectomy (CN) in metastatic nccRCC is contentious. Limited data exist on the role of CN in metastatic nccRCC under current standard of care. This retrospective study focused on the impact of upfront CN on metastatic nccRCC outcomes with first-line immune checkpoint inhibitor (IO) combinations or tyrosine kinase inhibitor (TKI) monotherapy. The study included 221 patients with nccRCC and synchronous metastatic disease, treated with IO combinations or TKI monotherapy in the first line. Baseline clinical characteristics, systemic therapy, and treatment outcomes were analyzed. The primary objective was to assess clinical outcomes, including progression-free survival (PFS) and overall survival (OS). Statistical analysis involved the Fisher exact test, Pearson's correlation coefficient, analysis of variance, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models. Median OS for patients undergoing upfront CN was 36.8 (95% confidence interval [CI] 24.9-71.3) versus 20.8 (95% CI 12.6-24.8) months for those without CN (p = 0.005). Upfront CN was significantly associated with OS in the multivariate Cox regression analysis (hazard ratio 0.47 [95% CI 0.31-0.72], p Our study demonstrates the survival benefits of upfront CN compared with systemic therapy without CN. The study suggests that the use of IO+TKI combination or, eventually, TKI monotherapy might be a better choice than IO+IO combination for patients who are not candidates for CN regardless of IO eligibility. Prospective trials are needed to validate these findings and refine the role of CN in current mRCC management
Estereotipos negativos de la vejez en los nuevos médicos internos residentes.
No full text20.500.12530/87873To determine the presence of negative stereotypes of old age in new medical intern residents (MIR) of the Community of Madrid. A descriptive cross-sectional survey study of first year MIRs was carried out anonymously during the process of registration at the Madrid College of Physicians between 25/03 and 26/05 of 2023. The Questionnaire of Negative Stereotypes towards Old Age (CENVE) and the Let's Fight All Together Against Ageism (LTJCE) survey were used. A total of 829 new MIRs were included, with a mean age of 26.0 (standard deviation [SD]=3.5) years. According to the LTJCE survey, 29.1% consider that in general older people are similar to each other; 47.5%, that deterioration of health in old age is inevitable, 26.8% that old age begins at 60 years; 30.5%, that age per se is a determinant when making clinical decisions and 31.0%, that aging is an obstacle that we must overcome in order to lead a healthy life. The mean total score of the CENVE scale (range 15-60) was 28.3 (SD=7.0) and the means of the different factors (range 5-20) were 8.6 (SD=2.8) for health; 9.8 (SD=2.6) for motivational-social; 10.0 (SD=2.7) for character-personality. Most new MIRs do not present old age-related stereotypes
Where are we with fractionation schedules and prescriptions in high-dose-rate 3D planning vaginal cuff brachytherapy?
No full textCurrently, there are many schedules for exclusive vaginal cuff brachytherapy (VCB). In 3D treatment planning for VCB dosimetry, parameters have not been analyzed. The aim of this study was to compare the most common schedules using dose-volume histogram metrics. Three different computed tomography (CT) studies for vaginal cylinders of 3.5 cm, 3 cm, and 2.5 cm were performed. Clinical target volume (CTV) was delineated for 3 cm and 4 cm of vaginal length. Twelve schedules were analyzed obtaining overall vaginal surface dose (Gy) (EQD2 α/β = 10 and α/β = 3), overall D90 CTV (α/β = 10) (Gy), and overall D2cc (α/β = 3) for organs at risk (OARs), such as vagina, rectum, sigmoid, rectum, and bladder. Prescription at 5 mm from the applicator surface and at the surface were analyzed for each case. The overall vaginal surface dose and dose to CTV varied widely among the different schedules, and CTV delineation was necessary in case of surface prescription. The applicator diameter of 3.5 cm showed the best dosimetry results for vaginal surface dose. The overall D2cc OARs' doses changed in the different CT studies. This dosimetry study allows for better selection of fractionation schedules, and helps to unify treatments among centers. Prospective studies are needed to establish the best schedule and CTV length in each patient using clinical data, such as late toxicity and relapses
Enhanced Immunomodulatory Effects of Thymosin-Alpha-1 in Combination with Polyanionic Carbosilane Dendrimers against HCMV Infection.
No full text20.500.12530/87858Resistance and toxicity associated with current treatments for human cytomegalovirus (HCMV) infection highlight the need for alternatives and immunotherapy has emerged as a promising strategy. This study examined the in vitro immunological effects of co-administration of Thymosin-alpha-1 (Tα1) and polyanionic carbosilane dendrimers (PCDs) on peripheral blood mononuclear cells (PBMCs) during HCMV infection. The biocompatibility of PCDs was assessed via MTT and LDH assays. PBMCs were pre-treated with the co-administered compounds and then exposed to HCMV for 48 h. Morphological alterations in PBMCs were observed using optical microscopy and total dendritic cells (tDCs), myeloid dendritic cells (mDCs), and plasmacytoid dendritic cells (pDCs), along with CD4+/CD8+ T cells and regulatory T cells (Treg), and were characterized using multiparametric flow cytometry. The findings revealed that Tα1 + PCDs treatments increased DC activation and maturation. Furthermore, increased co-receptor expression, intracellular IFNγ production in T cells and elevated Treg functionality and reduced senescence were evident with Tα1 + G2-S24P treatment. Conversely, reduced co-receptor expression, intracellular cytokine production in T cells, lower functionality and higher senescence in Treg were observed with Tα1 + G2S16 treatment. In summary, Tα1 + PCDs treatments demonstrate synergistic effects during early HCMV infection, suggesting their use as an alternative therapeutic for preventing virus infection