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1.
World J Gastroenterol ; 30(24): 3044-3047, 2024 Jun 28.
Article in English | MEDLINE | ID: mdl-38983964

ABSTRACT

We comment here on the article by Stefanolo et al entitled "Effect of Aspergillus niger prolyl endopeptidase in patients with celiac disease on a long-term gluten-free diet", published in the World Journal of Gastroenterology. Celiac disease is a well-recognized systemic autoimmune disorder. In genetically susceptible people, the most evident damage is located in the small intestine, and is caused and worsened by the ingestion of gluten. For that reason, celiac patients adopt a gluten-free diet (GFD), but it has some limitations, and it does not prevent re-exposure to gluten. Research aims to develop adjuvant therapies, and one of the most studied alternatives is supplementation with Aspergillus niger prolyl endopeptidase protease (AN-PEP), which is able to degrade gluten in the stomach, reducing its concentration in the small intestine. The study found a high adherence to the GFD, but did not address AN-PEP as a gluten immunogenic peptide reducer, as it was only tested in patients following a GFD and not in gluten-exposing conditions. This study opens up new research perspectives in this area and shows that further study is needed to clarify the points that are still in doubt.


Subject(s)
Aspergillus niger , Celiac Disease , Diet, Gluten-Free , Glutens , Prolyl Oligopeptidases , Serine Endopeptidases , Celiac Disease/immunology , Celiac Disease/microbiology , Celiac Disease/enzymology , Humans , Aspergillus niger/enzymology , Serine Endopeptidases/metabolism , Glutens/immunology , Glutens/metabolism , Glutens/adverse effects , Intestine, Small/microbiology , Intestine, Small/enzymology , Treatment Outcome
2.
Clin Transl Allergy ; 14(7): e12373, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38956447

ABSTRACT

BACKGROUND: The SQ tree sublingual immunotherapy (SLIT)-tablet is authorised for treatment of allergic rhinoconjunctivitis with or without asthma in trees of the birch homologous group in 21 European countries. The primary objective of this study was to explore the safety in real-life. METHODS: In a prospective, non-interventional post-authorisation safety study (EUPAS31470), adverse events (AEs) and adverse drug reactions (ADRs) at first administration and follow-up visits, symptoms, medication use, and pollen food syndrome were recorded by physicians in 6 European countries during the first 4-6 months of treatment. RESULTS: ADRs with the SQ tree SLIT-tablet were reported in 57.7% of 1069 total patients (median age 36.0 years, 53.7% female) during the entire observation period (severity, mild-to-moderate: 70.1%, severe: 4.7%, serious: 0.7%) and in 45.9% after first administration. ADRs were not increased with pollen exposure at first administration. With coadministration of the SQ tree and grass SLIT-tablet AEs were reported in 73.8% of patients and in 52.8% with the SQ tree SLIT-tablet alone. Nasal and eye symptoms improved in 86.9% and 80.9% of patients and use of symptomatic medication in 76.0%. PFS with symptoms was reported in 43.0% of patients at baseline and in 4.3% at the individual last visit. CONCLUSIONS: The results of this non-interventional safety study with the SQ tree SLIT-tablet confirm the safety profile from placebo-controlled clinical trials and support effectiveness in real-life according to the published efficacy data. Safety was not impaired by pollen exposure at first administration or co-administration with other SLIT-tablets.

3.
Eur J Cancer ; 208: 114210, 2024 Jul 04.
Article in English | MEDLINE | ID: mdl-39002346

ABSTRACT

INTRODUCTION: Considering the notable advances made in the treatment of lymphoma, assessment of health-related quality of life (HRQoL) of lymphoma patients has become a critical aspect to consider both in clinical research and routine practice. However, there is paucity of information about lymphoma specific HRQoL profile at diagnosis. PATIENTS AND METHODS: HRQoL at diagnosis was assessed for 3922 adult patients with newly diagnosed high-grade (HG) (n = 1994), low-grade (LG) (n = 1053) non-Hodgkin (NHL) and Hodgkin (HL) (n = 875) lymphomas included in REal world dAta in LYmphoma and Survival in Adults (REALYSA, NCT03869619), a prospective non-interventional multicentric cohort in France. Disease-specific HRQoL aspects were assessed with three validated EORTC questionnaires, namely, the QLQ-NHL-HG29, the QLQ-NHL-LG20 and the QLQ-HL27, for patients with NHL-HG, NHL-LG and HL, respectively. RESULTS: We confirmed the high-level of completion of these questionnaires in REALYSA cohort, ranging from 84 % for QLQ-HG29 to 88 % for QLQ-HL27. The proportion of patients with impaired global health status was as follows: T-cell NHL, 67 %; diffuse large B-cell (DLBCL), 62 %; Burkitt, 61 %; HL, 53 %; marginal zone, 49 %; mantle cell, 48 %; follicular, 47 %. Multivariable regression analyses for DLBCL, follicular and HL showed that gender, performance status and B symptoms were independently associated with all HRQoL dimensions. However, a variable effect of age and stage were observed among these three subtypes. CONCLUSIONS: A comprehensive analysis was made describing the HRQoL profile of newly diagnosed patients with different types of lymphomas. Our data may help to enhance the interpretation of HRQoL results in future studies using the recently validated EORTC lymphoma specific questionnaires.

4.
Article in English | MEDLINE | ID: mdl-38971686

ABSTRACT

AIMS: FAST-Forward and UK-FAST-trials have demonstrated the safety and efficacy of five-fraction breast adjuvant radiation therapy (RT) and have become the standard of care for selected early breast cancer patients. In response to the additional burden caused by the COVID-19 pandemic, we implemented "One-Week Breast RT," an innovative program delivering five-fraction whole breast RT in a complete 5-day workflow. The primary objective of this study was to demonstrate the feasibility and safety of our program. The secondary objective was to evaluate cosmetic results. MATERIAL AND METHODS: A total of 120 patients treated from February 2021 to March 2022, received whole breast RT without lymph node irradiation nor boost, with 26 Gy in five fractions over one week. Inverse planning with restricted optimization parameters offers systematic deep inspiration breath-hold aimed to provide treatment plans compliant with FAST-Forward recommendations. Toxicity and cosmetic evaluations were prospectively registered prior (pre-RT), at the end (end-RT), and 6 months after RT (6 months) based on Common Terminology Criteria for Adverse Events v. 4.03 and Harvard scale. RESULTS: With a median age of 70 years (interquartile range (IQR): 66-74) and a median follow-up of 6 months (IQR: 6.01-6.25), most patients (93.3%) completed their RT in one week from baseline to the end of the treatment consultation. The most common acute toxicities (at end-RT) were skin-related: radio-dermatitis (72%), induration (35%), hyperpigmentation (8%), and breast edema (16%). The rate of radio-dermatitis decreased from end-RT to 6 months (71.7% vs 5.4%, P< 0.001). No patient experienced grade ≥3 toxicity. At 6 months, cosmetic results were generally good or excellent (94.1%). CONCLUSION: This study confirms the feasibility and acute safety of the "One-Week Breast RT" in real life. Favorable toxicity profiles and good cosmetic outcomes are in line with FAST-Forward results. A prospective national cohort, aimed at decreasing treatment burden, maintaining safety, efficacy, and improving RT workflow efficiency with longer follow-up is ongoing.

5.
Article in English | MEDLINE | ID: mdl-38977481

ABSTRACT

PURPOSE: Antibody therapy for chronic rhinosinusitis with nasal polyps (CRSwNP) has been established in Germany since 2019. With limited long-term data on biologic treatment for CRSwNP, we conducted a comprehensive evaluation of our 4-year data. This monocentric study aims to assess the real-world effects of this treatment on clinical course, quality of life, treatment adherence, biologic switching, dual therapy, and comorbidities. METHODS: We retrospectively analysed biologic therapy data in patients with severe chronic rhinosinusitis with nasal polyps. 191 patients with CRSwNP treated with Dupilumab, Mepolizumab, or Omalizumab were observed for up to 4 years in a real-life setting. RESULTS: We observed clear symptom improvements with few side effects. No loss of efficacy or tolerability was noted during the 4-year period. Patients reported high satisfaction compared to previous therapies, with overall improved quality of life. Revision surgery or oral steroid use during biologic therapy was rare. Some patients prolonged injection intervals or discontinued steroid nasal spray. Biologic switching occurred infrequently due to side effects or inadequate response and was generally well tolerated. Many patients reported additional positive effects such as asthma or allergy symptom improvement and reduced medication intake. CONCLUSION: In summary, this study confirms the potency and tolerability of biologics for CRSwNP treatment, with sustained efficacy over 4 years. Biologic switching is a viable option for inadequate response or intolerable side effects. Therapy positively impacts Th2 comorbidities, corticosteroid requirements, surgery need, and overall compliance remains high. CLINICAL TRIAL REGISTRATION: Project No.: 22-0802. Registry name: Biologika bei Patient*innen mit chronischer Sinusitis mit Nasenpolypen.

6.
Dig Liver Dis ; 2024 Jul 13.
Article in English | MEDLINE | ID: mdl-39004550

ABSTRACT

BACKGROUND AND AIMS: To gather real-life data on biliary tract cancer (BTC) in France, an ambispective ACABi GERCOR Pronobil cohort was initiated. This nested study, Amber, utilized data from this cohort to document clinical practices in this setting. METHODS: Inclusion criteria encompassed patients with locally advanced/metastatic BTC managed between 2019 and 2021 in nine French referral hospitals. Objectives included describing demographic and clinical data, treatments outcomes (safety and efficacy), and overall survival. RESULTS: Of the 138 patients (median age 65 years, a balanced sex ratio) included, most displayed ECOG 0-1 (83 %), at least one comorbidity (79 %), and had intrahepatic (56 %) and metastatic (82 %) BTC. Among surgically-resected patients, 60 % received adjuvant chemotherapy, mainly capecitabine (67 %). CisGem, the primary first-line palliative chemotherapy (69 %), showed a 23 % objective response rate, a median progression-free survival of 5.3 months, and a median overall survival of 13.4 months. Second-, third-, and fourth-line were given to 75 % (FOLFOX: 35 %, targeted therapy: 14 %), 32 %, and 13 % of patients. In total, 67 % of patients had a molecular profile (IDH1 mutations and FGFR2 fusions: accounting for 21 % each in intrahepatic cholangiocarcinoma). CONCLUSION: BTC patients were predominantly treated according to international recommendations. The obtained demographic, tumor, and molecular data were consistent with existing literature.

7.
Neuron ; 2024 May 23.
Article in English | MEDLINE | ID: mdl-38823391

ABSTRACT

Neurons from multiple prefrontal areas encode several key variables of social gaze interaction. To explore the causal roles of the primate prefrontal cortex in real-life gaze interaction, we applied weak closed-loop microstimulations that were precisely triggered by specific social gaze events. Microstimulations of the orbitofrontal cortex, but not the dorsomedial prefrontal cortex or the anterior cingulate cortex, enhanced momentary dynamic social attention in the spatial dimension by decreasing the distance of fixations relative to a partner's eyes and in the temporal dimension by reducing the inter-looking interval and the latency to reciprocate the other's directed gaze. By contrast, on a longer timescale, microstimulations of the dorsomedial prefrontal cortex modulated inter-individual gaze dynamics relative to one's own gaze positions. These findings demonstrate that multiple regions in the primate prefrontal cortex may serve as functionally accessible nodes in controlling different aspects of dynamic social attention and suggest their potential for a therapeutic brain interface.

8.
Heliyon ; 10(11): e32181, 2024 Jun 15.
Article in English | MEDLINE | ID: mdl-38867968

ABSTRACT

Nerve agents represent a serious threat to security worldwide. Chemical terrorism has become an alarming danger since the technological progresses have simplified the production of nerve agents. Therefore, there is an immediate demand for a fast and precise detection of these compounds on-site and real-time. In this perspective, Surface-Enhanced Raman Scattering (SERS) has emerged as a well-suited alternative for on-field detection. SERS performances of unfunctionalized SERS substrates were evaluated in realistic samples. Two nerve agents, Tabun and VX, were diluted in two matrix models: a contact lens solution, and a caffeine-based eye serum. The performance two research-grade instruments and two portable devices were compared. Despite the use of a small sampling volume of complex matrices without any sample pre-treatment, we achieved Tabun detection in both media, with a practical limit of detection (LOD) in the range of 7-9 ppm in contact lens liquid, and of 10.2 ppm in eye serum. VX detection turned out to be more challenging and was achieved only in contact lens solution, with a practical LOD in the range of 0.6-5 ppm. These results demonstrate the feasibility of on-field detection of nerve agents with SERS, that could be implemented when there is suspicion of chemical threat.

9.
Diabetes Obes Metab ; 2024 Jun 20.
Article in English | MEDLINE | ID: mdl-38899554

ABSTRACT

AIM: To determine whether recent repeated exposure to real-life hypoglycaemia affects the pro-inflammatory response during a hypoglycemia episode. MATERIALS AND METHODS: This was a post hoc analysis of a hyperinsulinaemic normoglycaemic-hypoglycaemic clamp study, involving 40 participants with type 1 diabetes. Glucose levels 1 week before the clamp were monitored using a Freestyle Libre 1. Blood was drawn during normoglycaemia and hypoglycaemia, and 24 hours after resolution of hypoglycaemia for measurements of inflammatory responses and counterregulatory hormone levels. We determined the relationship between the frequency and duration of spontaneous hypoglycaemia, and time below range (TBR) and the inflammatory response to experimental hypoglycaemia. RESULTS: On average, participants experienced 0.79 (0.43, 1.14) hypoglycaemia episodes per day, with a duration of 78 (47, 110) minutes and TBR of 5.5% (2.8%, 8.5%). TBR and hypoglycaemia frequency were inversely associated with the increase in circulating granulocyte and lymphocyte counts during experimental hypoglycaemia (P < .05 for all). A protein network consisting of DNER, IF-R, uPA, Flt3L, FGF-5 and TWEAK was negatively associated with hypoglycaemia frequency (P < .05), but not with the adrenaline response. Neither other counterregulatory hormones, nor hypoglycaemia awareness status, was associated with any of the inflammatory parameters markers. CONCLUSIONS: Repeated exposure to spontaneous hypoglycaemia is associated with blunted effects of subsequent experimental hypoglycaemia on circulating immune cells and the number of inflammatory proteins.

10.
J Cardiothorac Surg ; 19(1): 340, 2024 Jun 21.
Article in English | MEDLINE | ID: mdl-38902742

ABSTRACT

BACKGROUND: The aim of this study is to report the preliminary real-word clinical and hemodynamic performance from the MANTRA study in patients undergoing aortic valve replacement with Perceval PLUS sutureless valve. METHODS: MANTRA is an ongoing "umbrella" prospective, multi-center, international post-market study to collect real-life safety and performance data on Corcym devices (Corcym S.r.l, Saluggia, Italy). Clinical and echocardiographic outcomes were collected preoperatively, at discharge and at each follow up. KCCQ-12 and EQ-5D-5L quality of life questionnaires were collected preoperatively and at 30-days. RESULTS: A total of 328 patients underwent aortic valve replacement with Perceval PLUS in 29 International institutions. Patients were enrolled from July 2021 to October 2023 and enrollment is still ongoing. Mean age was 71.9 ± 6.4 years, mean EuroSCORE II was 2.9 ± 3.9. Minimally invasive approach was performed in 44.2% (145/328) of patients; concomitant procedures were done in 40.8% (134/328) of cases. Thirty-day mortality was 1.8% (6/328) and no re-interventions were reported. Pacemaker implant was required in 4.0% (13/328) of the patients. The assessment of the functional status demonstrated marked and stable improvement in NYHA class in most patients at 30-day follow-up, with significant increase of KCCQ-12 summary score (from 58.8 ± 23.0 to 71.8 ± 22.1, p < 0.0001) and EQ-5D-5L VAS score (from 64.5 ± 20.4 to 72.6 ± 17.5, p < 0.0001). Mean pressure gradient decreased from 46.2 ± 17.3 mmHg to 10.1 ± 4.7 mmHg at 30-day follow-up. Low or no incidence of moderate-to-severe paravalvular or central leak was reported. CONCLUSIONS: Preliminary results demonstrate good clinical outcomes and significant improvement of Quality of Life at 30-days, excellent early hemodynamic performance within patient implanted with Perceval PLUS. TRIAL REGISTRATION: The MANTRA study has been registered in ClinicalTrials.gov (NCT05002543, Initial release 26 July 2021).


Subject(s)
Aortic Valve Stenosis , Aortic Valve , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Humans , Aged , Male , Female , Prospective Studies , Aortic Valve/surgery , Heart Valve Prosthesis Implantation/methods , Treatment Outcome , Aortic Valve Stenosis/surgery , Prosthesis Design , Sutureless Surgical Procedures/methods , Quality of Life , Hemodynamics/physiology , Aged, 80 and over , Middle Aged
11.
World J Urol ; 42(1): 386, 2024 Jun 25.
Article in English | MEDLINE | ID: mdl-38918219

ABSTRACT

BACKGROUND: The last decades revealed new scientific knowledge regarding the fertility and potential malignancy of undescended testis AQ2(UDT). Accordingly, many guidelines changed their recommendation concerning timing of therapy, with the goal of an earlier time of surgery. METHODS: We analyzed the number of new diagnosis and performed surgeries in predefined age groups provided by the obligatory annual reports of German hospitals in the reimbursement.INFO"-tool between 2006 and 2020. RESULTS: Overall, 124,741 cases were analyzed. We showed a slight increase in performed surgeries in the first year by 2% per year with a main increase till 2011, a constant number of surgeries between first and 4th year and a decrease of surgeries between 5 and 14th year of living with a main decrease till 2009 by 3% per year. CONCLUSION: Even if our results illustrate an increasing adaption of the guideline's recommendation, there is still a significant number of patients who receive later treatment. More research about the reasons and circumstances for the latter is needed.


Subject(s)
Cryptorchidism , Orchiopexy , Practice Guidelines as Topic , Cryptorchidism/surgery , Humans , Male , Germany/epidemiology , Child , Adolescent , Child, Preschool , Infant , Time Factors , Young Adult , Adult
12.
Pediatr Pulmonol ; 2024 Jun 27.
Article in English | MEDLINE | ID: mdl-38934778

ABSTRACT

BACKGROUND & OBJECTIVES: Despite the availability of biologics for severe pediatric asthma, real-life studies reporting on drivers behind initiating biologics and their alignment with the Global Initiative for Asthma (GINA) recommendations are lacking. METHODS: We performed analysis within the pediatric asthma noninvasive diagnostic approaches study, a prospective cohort of 6- to 17-year-old children with severe asthma. Information was collected on demographic factors, symptom control, treatment, comorbidities, and diagnostic tests from medical records and questionnaires. We divided patients into "starters" or "nonstarters" based on the clinical decision to initiate biologics and performed multivariate logistic regression analysis to identify drivers behind initiating therapy. Additionally, we assessed patient suitability for biologics according to key factors in the GINA recommendations: Type 2 inflammation, frequency of exacerbations, and optimization of treatment adherence. RESULTS: In total, 72 children (mean age 11.5 ± 3.0 years, 65.3% male) were included (13 starters). Initiation of biologics was associated with a higher GINA treatment step (adjusted odds ratio's [aOR] = 5.0, 95%CI 1.33-18.76), steroid toxicity (aOR = 21.1, 95%CI 3.73-119.91), frequency of exacerbations (aOR = 1.6, 95%CI 1.10-2.39), improved therapy adherence (aOR = 1.7, 95%CI 1.10-2.46), Caucasian ethnicity (aOR = 0.20, 95%CI 0.05-0.80), ≥1 allergic sensitization (aOR = 0.06, 95%CI 0.004-0.97), and allergic rhinitis (aOR = 0.13, 95%CI 0.03-0.65). Furthermore, steroid toxicity was identified as an important factor for deviation from the current recommendations on biologic prescription. CONCLUSIONS: We identified multiple drivers and inhibitors for initiating biologics, and showed the clinical need for biologics in severe pediatric asthmatics suffering from steroid toxicity. These findings may help refine asthma management guidelines.

13.
Hosp Pharm ; 59(4): 476-484, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38919754

ABSTRACT

Background: Adherence and persistence to treatment with disease-modifying therapies (DMTs) is a predictor of the efficacy of treatment. Aims: The objectives of the study were the analysis of adherence, persistence, switches, and costs of the drugs used in MS. Methods: This is a retrospective non-interventional pharmacological observational study of 610 patients diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) under therapy between January 2007 and September 2022. Results: Adherence values were greater than 0.75 for all the drugs in considered for the study. The mean persistence value was 2.5 years on the analysis performed on the first-line treatment. Conclusion: In a therapy in which adherence is predominant, but not exclusive to therapy efficacy, persistence to the drug is synonymous with drug efficacy.


Multiple Sclerosis (MS) is a chronic disease that often begins early in life. Like in many chronic diseases, consistent adherence to treatment is vital for the long-term effectiveness of therapies. In MS, most treatments­whether oral or parenteral­are self-administered at home, making long-term adherence crucial. Persistence in sticking with a single drug is also seen as an indicator of the treatment's effectiveness, as longer use generally means fewer therapy changes and greater drug efficacy. This article analyzes these key pharmacy utilization metrics­adherence, persistence, and therapy switches­to directly compare the real-world effectiveness of the most commonly used MS drugs.

14.
Trends Parasitol ; 40(7): 537-540, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38853078

ABSTRACT

Careful observation of parasites, masters of camouflage, reveals an ingenious and fascinating world. However, students often perceive parasitology as impenetrable. What if a flamboyant flea circus director passionately introduced the multidimensional contexts of this discipline? Will role-play capture the imagination of students and guide them in their future learning?


Subject(s)
Parasitology , Animals , Humans , Parasitology/education , Parasitology/trends , Role Playing , Students/psychology , Teaching
15.
ESMO Open ; 9(6): 103473, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38833966

ABSTRACT

PURPOSE: The RAS/MEK signaling pathway is essential in carcinogenesis and frequently altered in non-small-cell lung cancer (NSCLC), notably by KRAS mutations (KRASm) that affect 25%-30% of non-squamous NSCLC. This study aims to explore the impact of KRASm subtypes on disease phenotype and survival outcomes. PATIENTS AND METHODS: We conducted a retrospective analysis of the French Epidemiological Strategy and Medical Economics database for advanced or metastatic lung cancer from 2011 to 2021. Patient demographics, histology, KRASm status, treatment strategies, and outcomes were assessed. RESULTS: Of 10 177 assessable patients for KRAS status, 17.6% had KRAS p.G12C mutation, 22.6% had KRAS non-p.G12C mutation, and 59.8% were KRASwt. KRASm patients were more often smokers (96.3%) compared with KRASwt (85.8%). A higher proportion of programmed death-ligand 1 ≥50% was found for KRASm patients: 43.5% versus 38.0% (P < 0.01). KRASm correlated with poorer outcomes. First-line median progression-free survival was shorter in the KRASm than the KRASwt cohort: 4.0 months [95% confidence interval (CI) 3.7-4.3 months] versus 5.1 months (95% CI 4.8-5.3 months), P < 0.001. First-line overall survival was shorter for KRASm than KRASwt patients: 12.6 months (95% CI 11.6-13.6 months) versus 15.4 months (95% CI 14.6-16.2 months), P = 0.012. First-line chemoimmunotherapy offered better overall survival in KRAS p.G12C (48.8 months) compared with KRAS non-p.G12C (24.0 months) and KRASwt (22.5 months) patients. Second-line overall survival with immunotherapy was superior in the KRAS p.G12C subgroup: 12.6 months (95% CI 8.1-18.6 months) compared with 9.4 months (95% CI 8.0-11.4 months) for KRAS non-p.G12C and 9.6 months (8.4-11.0 months) for KRASwt patients. CONCLUSION: We highlighted distinct clinical profiles and survival outcomes according to KRASm subtypes. Notably KRAS p.G12C mutations may provide increased sensitivity to immunotherapy, suggesting potential therapeutic implications for sequencing or combination of therapies. Further research on the impact of emerging KRAS specific inhibitors are warranted in real-world cohorts.


Subject(s)
Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Mutation , Proto-Oncogene Proteins p21(ras) , Humans , Carcinoma, Non-Small-Cell Lung/genetics , Carcinoma, Non-Small-Cell Lung/mortality , Carcinoma, Non-Small-Cell Lung/pathology , Carcinoma, Non-Small-Cell Lung/drug therapy , Male , Female , Proto-Oncogene Proteins p21(ras)/genetics , Lung Neoplasms/genetics , Lung Neoplasms/mortality , Lung Neoplasms/pathology , Lung Neoplasms/drug therapy , Retrospective Studies , Aged , Middle Aged , France/epidemiology
16.
Expert Opin Drug Saf ; : 1-5, 2024 May 08.
Article in English | MEDLINE | ID: mdl-38717372

ABSTRACT

BACKGROUND: Alopecia areata (AA) is a non-scarring disorder characterized by hair loss that greatly affects patients' quality of life and has a chronic, recurring course. This disease is marked by an inflammatory process, mainly on an autoimmune basis primarily regulated by Janus kinase (JAK). RESEARCH DESIGN AND METHODS: We conducted a retrospective study evaluating the safety of JAKi in a real-world setting in 91 AA patients, with a specific focus on the assessment of infectious events. RESULTS: Overall, 34 infectious events were observed in 28 patients (30.8%), among them 17 patients (60.7%) suspended treatment with JAKi until the infection was clinically resolved. Only in one case the infectious event led to a permanent discontinuation of the treatment. The data we observed in the study are consistent with results reported in clinical trials. CONCLUSION: It can be stated that, during treatment with JAKi in AA patients, infectious events may occur, but in most cases these events are easily manageable and do not result in permanent discontinuation of the drug.

17.
Front Psychol ; 15: 1386676, 2024.
Article in English | MEDLINE | ID: mdl-38784630

ABSTRACT

Introduction: The capacity to understand others' emotions and react accordingly is a key social ability. However, it may be compromised in case of a profound sensory loss that limits the contribution of available contextual cues (e.g., facial expression, gestures, body posture) to interpret emotions expressed by others. In this study, we specifically investigated whether early blindness affects the capacity to interpret emotional vocalizations, whose valence may be difficult to recognize without a meaningful context. Methods: We asked a group of early blind (N = 22) and sighted controls (N = 22) to evaluate the valence and the intensity of spontaneous fearful and joyful non-verbal vocalizations. Results: Our data showed that emotional vocalizations presented alone (i.e., with no contextual information) are similarly ambiguous for blind and sighted individuals but are perceived as more intense by the former possibly reflecting their higher saliency when visual experience is unavailable. Disussion: Our study contributes to a better understanding of how sensory experience shapes ememotion recognition.

18.
Dev Cogn Neurosci ; 67: 101391, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38759529

ABSTRACT

The field of developmental cognitive neuroscience is advancing rapidly, with large-scale, population-wide, longitudinal studies emerging as a key means of unraveling the complexity of the developing brain and cognitive processes in children. While numerous neuroscientific techniques like functional magnetic resonance imaging (fMRI), functional near-infrared spectroscopy (fNIRS), magnetoencephalography (MEG), and transcranial magnetic stimulation (TMS) have proved advantageous in such investigations, this perspective proposes a renewed focus on electroencephalography (EEG), leveraging underexplored possibilities of EEG. In addition to its temporal precision, low costs, and ease of application, EEG distinguishes itself with its ability to capture neural activity linked to social interactions in increasingly ecologically valid settings. Specifically, EEG can be measured during social interactions in the lab, hyperscanning can be used to study brain activity in two (or more) people simultaneously, and mobile EEG can be used to measure brain activity in real-life settings. This perspective paper summarizes research in these three areas, making a persuasive argument for the renewed inclusion of EEG into the toolkit of developmental cognitive and social neuroscientists.


Subject(s)
Cognitive Neuroscience , Electroencephalography , Social Interaction , Humans , Electroencephalography/methods , Cognitive Neuroscience/methods , Brain/physiology
19.
Int J Audiol ; : 1-10, 2024 May 03.
Article in English | MEDLINE | ID: mdl-38701176

ABSTRACT

OBJECTIVE: Adults typically receive only one cochlear implant (CI) due to cost constraints, with a contralateral hearing aid recommended when there is aidable hearing. Standard hearing aids differ from a CI in terms of processing strategy and function as a separate entity, requiring the user to integrate the disparate signals. Integrated bimodal technology has recently been introduced to address this challenge. The aim of the study was to investigate the performance of unilateral CI users with and without an integrated bimodal fitting and determine whether binaural streaming technology offers additional benefit. STUDY SAMPLE: Twenty-six CI users using integrated bimodal technology. DESIGN: Repeated measures where outcomes and user experience were assessed using a functional test battery more representative of real life listening (speech perception in noise tests, localisation test, tracking test) and the speech, spatial and qualities-of-hearing scale (SSQ). RESULTS: Bimodal outcomes were significantly better than for CI alone. Speech perception in noise improvements ranged from 1.4 dB to 3.5 dB depending on the location of speech and noise. The localisation and tracking tests, and the SSQ also showed significant improvements. Binaural streaming offered additional improvement (1.2 dB to 6.1 dB on the different speech tests). CONCLUSIONS: Integrated bimodal and binaural streaming technology improved the performance of unilateral CI users.

20.
Ann Hematol ; 103(7): 2347-2354, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38771499

ABSTRACT

Ropeginterferon-alfa2b (ropegIFNα2b) is a long-acting IFN formulation with broad FDA/EMA approval as a therapy of polycythemia vera (PV) with no symptomatic splenomegaly. There is currently lack of information on the real-world patient selection, including the impact of local reimbursement policies, and drug management, particularly: type/timing of screening and follow-up tests; absolute/relative contraindications to therapy; ropegIFNα2b dose and combinations with hydroxyurea. As a sub-analysis of the PV-ARC retrospective study (NCT06134102), we here report our monocenter experience with ropegIFNα2b in the period from January 2021, corresponding to drug availability outside clinical trial, and December 2023. Among the 149 patients with EMA/FDA indication, only 55 (36.9%) met the local reimbursement criteria and 18 (12.1%) received ropegIFNα2b. Thanks to appropriate screening, relative/absolute contraindications to ropegIFNα2b were detected and managed in a multidisciplinary manner. Efficacy and safety of ropegIFNα2b was confirmed, with 3 cases of early molecular response. General use of low ropegIFNα2b dose, with frequent need for hydroxyurea combinations, was noted. This real-world experience suggests a significant impact of local regulations on drug prescription and the need for greater real-world data collection on ropegIFNα2b in PV patients. Also, it describes appropriate multidisciplinary screening and monitoring procedures during ropegIFNα2b therapy.


Subject(s)
Interferon alpha-2 , Interferon-alpha , Polycythemia Vera , Polyethylene Glycols , Recombinant Proteins , Humans , Polycythemia Vera/drug therapy , Interferon-alpha/therapeutic use , Interferon-alpha/administration & dosage , Polyethylene Glycols/therapeutic use , Polyethylene Glycols/administration & dosage , Recombinant Proteins/therapeutic use , Interferon alpha-2/therapeutic use , Male , Middle Aged , Retrospective Studies , Female , Aged , Patient Selection , Treatment Outcome , Adult , Hydroxyurea/therapeutic use , Hydroxyurea/administration & dosage
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