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1.
Sensors (Basel) ; 24(4)2024 Feb 17.
Artigo em Inglês | MEDLINE | ID: mdl-38400457

RESUMO

In the era of big data, millions and millions of data are generated every second by different types of devices. Training machine-learning models with these data has become increasingly common. However, the data used for training are often sensitive and may contain information such as medical, banking, or consumer records, for example. These data can cause problems in people's lives if they are leaked and also incur sanctions for companies that leak personal information for any reason. In this context, Federated Learning emerges as a solution to the privacy of personal data. However, even when only the gradients of the local models are shared with the central server, some attacks can reconstruct user data, allowing a malicious server to violate the FL principle, which is to ensure the privacy of local data. We propose a secure aggregation protocol for Decentralized Federated Learning, which does not require a central server to orchestrate the aggregation process. To achieve this, we combined a Multi-Secret-Sharing scheme with a Dining Cryptographers Network. We validate the proposed protocol in simulations using the MNIST handwritten digits dataset. This protocol achieves results comparable to Federated Learning with the FedAvg protocol while adding a layer of privacy to the models. Furthermore, it obtains a timing performance that does not significantly affect the total training time, unlike protocols that use Homomorphic Encryption.

2.
Breast Cancer Res ; 25(1): 78, 2023 06 29.
Artigo em Inglês | MEDLINE | ID: mdl-37386484

RESUMO

BACKGROUND: New drugs for locally advanced or metastatic breast cancer have led to clinical benefits, aside with increasing costs to healthcare systems. The current financing model for health technology assessment (HTA) privileges real-world data. As part of the ongoing HTA, this study aimed to evaluate the effectiveness of palbociclib with aromatase inhibitors (AI) and compare it with the efficacy reported in PALOMA-2. METHODS: A population-based retrospective exposure cohort study was conducted including all patients initiating treatment in Portugal with palbociclib under early access use and registered in the National Oncology Registry. The primary outcome was progression free survival (PFS). Secondary outcomes considered included time to palbociclib failure (TPF), overall survival (OS), time to next treatment (TTNT), and proportion of patients discontinuing treatment due to  adverse events (AEs). The Kaplan-Meier method was used and median, 1- and 2-year survival rates were computed, with two-sided 95% confidence intervals (95%CI). STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guidelines for reporting observational studies were used. RESULTS: There were 131 patients included. Median follow-up was 28.3 months (IQR: 22.7-35.2) and median duration of treatment was 17.5 months (IQR: 7.8-29.1). Median PFS was 19.5 months (95%CI 14.2-24.2), corresponding to a 1-year PFS rate of 67.9% (95%CI 59.2-75.2) and a 2-year PFS rate of 42.0% (95%CI 33.5-50.3). Sensitivity analysis showed median PFS would increase slightly when excluding those not initiating treatment with the recommended dose, raising to 19.8 months (95%CI 14.4-28.9). By considering only patients meeting PALOMA-2 criteria, we could observe a major difference in treatment outcomes, with a mean PFS of 28.8 months (95%CI 19.4-36.0). TPF was 19.8 months (95%CI 14.2-24.9). Median OS was not reached. Median TTNT was 22.5 months (95%CI 18.0-29.8). A total of 14 patients discontinued palbociclib because of AEs (10.7%). CONCLUSIONS: Data suggest palbociclib with AI to have an effectiveness of 28.8 months, when used in patients with overlapping characteristics to those used in PALOMA-2. However, when used outside of these eligibility criteria, namely in patients with less favorable prognosis (e.g., presence of visceral disease), the benefits are inferior, even though still favorable.


Assuntos
Inibidores da Aromatase , Neoplasias da Mama , Humanos , Feminino , Inibidores da Aromatase/efeitos adversos , Estudos Retrospectivos , Neoplasias da Mama/tratamento farmacológico , Estudos de Coortes
3.
Br J Haematol ; 197(4): 431-441, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35255152

RESUMO

Selecting the most appropriate chronic lymphocytic leukaemia (CLL) treatment is challenging. Patient-reported health-related quality of life (HRQoL) is therefore a critical aspect to consider. This international study by the European Organization for Research and Treatment of Cancer (EORTC) tested the psychometric properties of a newly developed measure for CLL patients: the EORTC QLQ-CLL17 to supplement the core questionnaire (EORTC QLQ-C30). Patients with CLL (n = 341) from 12 countries completed the QLQ-C30, QLQ-CLL17 and a debriefing questionnaire. Sociodemographic and clinical data were recorded from medical records. A high percentage (30%-66%) reported symptoms and/or worries (e.g. aches/pains in muscles, lack of energy and worry/fears about health). Confirmatory factor analysis showed an acceptable to good fit of the 17 items on the three scales (i.e. symptom burden, physical condition/fatigue and worries/fears about health and functioning). Completion took on average 8 min. Test-retest and convergent validity was demonstrated. The QLQ-CLL17 differentiated between patients with an Eastern Cooperative Oncology group (ECOG) performance of 0 versus 1-3 (p's < 0.01 and clinically relevant). The newly developed EORTC QLQ-CLL17 will increase sensitivity of HRQoL assessment in patients with CLL. Implementation of this questionnaire both in clinical research and practice will help to generate unique clinically relevant data to better inform CLL treatment decision-making.


Assuntos
Leucemia Linfocítica Crônica de Células B , Qualidade de Vida , Humanos , Dor , Psicometria , Reprodutibilidade dos Testes , Inquéritos e Questionários
4.
Sensors (Basel) ; 22(16)2022 Aug 15.
Artigo em Inglês | MEDLINE | ID: mdl-36015857

RESUMO

This work aims to analyze two metaheuristics optimization techniques, Genetic Algorithm (GA) and Particle Swarm Optimization (PSO), with six variations each, and compare them regarding their convergence, quality, and dispersion of solutions. The optimization target is the Gaussian Adaptive PID control (GAPID) to find the best parameters to achieve enhanced performance and robustness to load variations related to the traditional PID. The adaptive rule of GAPID is based on a Gaussian function that has as adjustment parameters its concavity and the lower and upper bound of the gains. It is a smooth function with smooth derivatives. As a result, it helps avoid problems related to abrupt increases transition, commonly found in other adaptive methods. Because there is no mathematical methodology to set these parameters, this work used bio-inspired optimization algorithms. The test plant is a DC motor with a beam with a variable load. Results obtained by load and gain sweep tests prove the GAPID presents fast responses with very low overshoot and good robustness to load changes, with minimal variations, which is impossible to achieve when using the linear PID.


Assuntos
Algoritmos
5.
Pharmacoepidemiol Drug Saf ; 30(3): 342-349, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33103788

RESUMO

OBJECTIVES: To evaluate the effectiveness and safety of pembrolizumab use in advanced melanoma in a real-life context; and to explore the existence of an efficacy-effectiveness gap, comparing registry data with the reference clinical trial. METHODS: This study followed the guidelines for good pharmacoepidemology practice. An ambispective cohort was constituted, initiating the observation upon drug approval (17/07/2015) and following exposed patients until death or cut-off date (15/11/2019). The primary outcome was overall survival (OS); secondary outcomes comprised progression-free survival (PFS), overall response rate (ORR) and the occurrence of adverse events (AE). For all survival analyses, the Kaplan-Meier estimator was used, considering a 95% confidence interval (CI), aside with one-year survival rates. RESULTS: A total of 125 patients constituted the cohort, originating from 16 hospitals in Portugal. Median OS was estimated to be 16.9 months (CI95% 11.3-25.5) and the probability of survival after 1 year was 57.5% (CI95% 48.4%-65.6%). Median PFS was estimated to be 4.8 months (CI95% 3.9-6.7) and the probability of remaining progression-free after 1 year was 32.8% (CI95% 24.8-41.1). ORR was 30.4% (CI95% 22.5%-39.3%). AEs were experienced by 82% of patients, and 27% experienced AE≥ grade 3. CONCLUSIONS: Our data suggest lower effectiveness in a real-life context than the efficacy reported in the clinical trial. Safety data seems, however, quite comparable to KEYNOTE-006.


Assuntos
Antineoplásicos Imunológicos , Melanoma , Anticorpos Monoclonais Humanizados , Antineoplásicos Imunológicos/efeitos adversos , Humanos , Melanoma/tratamento farmacológico , Portugal/epidemiologia , Sistema de Registros
6.
Photodermatol Photoimmunol Photomed ; 37(6): 521-529, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34080246

RESUMO

INTRODUCTION: Microneedling promotes skin microlesions that lead to an inflammatory process, increasing cell proliferation, cell metabolism, and synthesis of collagen and elastin, therefore restoring skin integrity. OBJECTIVE: This study aims to investigate the differences between the physical and the physical-chemical sunscreen application after microneedling, assessed through histological analysis. METHOD: This was a two-phase study. The first phase investigated the physical and physical-chemical sunscreen penetration mixed with India ink through histological analysis. The sunscreens were applied after the microleakage in vivo on the skin of a volunteer who underwent abdominoplasty 24 hours after the procedure. Histological analyses were carried out using optical and electron microscopy. The second phase analysed the skin reactions with the use of physical sunscreen after different microneedling treatments. The sample consisted of 30 volunteers distributed into three groups: G1 received the "Roller" microneedling, G2 received pen micropuncture treatment, and G3 received the fractional radiofrequency treatment. RESULTS: The histological analyses of the first phase indicated that the physical-chemical protection sunscreen penetrated more deeply, and pigment was found among the collagen fibres and the dermal fibroblast cytoplasm in comparison to the physical protection sunscreen, which had the pigment confined exclusively in the superficial epidermis layer. The second phase results demonstrated that the use of the physical protection sunscreen after the different microneedling techniques showed no adverse reactions such as itching, pain or soreness, and the hyperaemia. CONCLUSION: The proposed intervention showed that the use of physical protection sunscreen after different microneedling procedures is safe.


Assuntos
Agulhas , Protetores Solares , Colágeno , Epiderme , Humanos , Pele
7.
An Acad Bras Cienc ; 93(4): e20200205, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34705937

RESUMO

The present work evaluated the efficiency of applied biological control and chemical control of Chrysodeixis includens, and the management of this looper caterpillar in the field soybean crop. The experimental design was a randomized complete block design, consisting of six treatments applied only once: two different doses of Bacillus thuringiensis (Bt), 0.2 and 0.35 L ha-1; Metarhizium rileyi strain UFMS 02 (Mr), 2.0 and 5.0 kg ha-1; insecticide Flubendiamide (Fd) 20 mL ha-1; and the control. The reduction of the pest and the percentage of efficiency of the products along the development of the soybean, besides some phytotechnical parameters, were evaluated thirteen days after the application. In general, there was a decrease in the number of caterpillars after thirteen days of spraying, with the Bt treatment being 350 mL ha-1, which provided the greatest reduction in the population (96.2%) when compared to the control (6.7 %). Regarding efficiency, treatments containing biological products Bt (two doses) and Mr 5.0 kg ha-1 provided the best results: 95.88, 84.69 and 92.35%, respectively. Among the phytotechnical parameters evaluated, the biological treatments were superior to the chemical treatments in relation to the productivity and the number of pods per plant, not differing statistically among them.


Assuntos
Proteínas Hemolisinas , Mariposas , Animais , Toxinas de Bacillus thuringiensis , Proteínas de Bactérias , Endotoxinas , Larva , Metarhizium , Controle Biológico de Vetores , Glycine max
8.
Pharmacoepidemiol Drug Saf ; 29(10): 1295-1302, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32844487

RESUMO

PURPOSE: Immunotherapy is promising for lung cancer treatment, although at significant financial impact. The aim of this study was to evaluate the effectiveness and the efficacy-effectiveness gap of pembrolizumab in previously treated non-small cell lung cancer (NSCLC). METHODS: A population-based ambispective cohort study was conducted. Cases of interest were identified through the National Cancer Registry database and additional data sources. Patients aged ≥18 years, diagnosed with NSCLC and exposed to pembrolizumab, between 23 June 2016 and 31 October 2018, as second or later lines of treatment for advanced disease were included. Patients were followed-up until death or cut-off date (30 April 2019). Primary outcome was overall survival (OS). Secondary outcomes were progression-free survival (PFS), event-free survival (EFS), and adverse events (AEs) leading to treatment discontinuation. The efficacy-effectiveness gap was evaluated comparing results with clinical trial data. RESULTS: A total of 181 patients were included. Median age was 63 years (range 33-94); 74.6% were male. Median treatment duration was 5.6 months (interquartile range: 1.4-10.4) and, at cut-off date, treatment had been discontinued in 141 patients, mainly due to disease progression. Median OS was 13.0 months (95% confidence interval [CI] 9.3-15.9) and 1-year OS was 53.1% (95% CI 45.2%-60.3%). Median PFS was 5.6 months (95% CI 4.6-7.2), median EFS was 4.7 months (95% CI 3.2-6.0), and treatment was discontinued due to AE in 8.3% of cases (n = 15). The efficacy-effectiveness gap seems to favor pembrolizumab use in clinical practice. CONCLUSION: Real-world data suggest the performance of pembrolizumab to reflect the clinical trial outcomes in previously treated NSCLC.


Assuntos
Anticorpos Monoclonais Humanizados/administração & dosagem , Antineoplásicos Imunológicos/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados/efeitos adversos , Antineoplásicos Imunológicos/efeitos adversos , Estudos de Coortes , Progressão da Doença , Intervalo Livre de Doença , Feminino , Humanos , Imunoterapia/métodos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Estudos Retrospectivos , Taxa de Sobrevida , Resultado do Tratamento
9.
Sensors (Basel) ; 18(5)2018 Apr 24.
Artigo em Inglês | MEDLINE | ID: mdl-29695066

RESUMO

Researches in Artificial Intelligence (AI) have achieved many important breakthroughs, especially in recent years. In some cases, AI learns alone from scratch and performs human tasks faster and better than humans. With the recent advances in AI, it is natural to wonder whether Artificial Neural Networks will be used to successfully create or break cryptographic algorithms. Bibliographic review shows the main approach to this problem have been addressed throughout complex Neural Networks, but without understanding or proving the security of the generated model. This paper presents an analysis of the security of cryptographic algorithms generated by a new technique called Adversarial Neural Cryptography (ANC). Using the proposed network, we show limitations and directions to improve the current approach of ANC. Training the proposed Artificial Neural Network with the improved model of ANC, we show that artificially intelligent agents can learn the unbreakable One-Time Pad (OTP) algorithm, without human knowledge, to communicate securely through an insecure communication channel. This paper shows in which conditions an AI agent can learn a secure encryption scheme. However, it also shows that, without a stronger adversary, it is more likely to obtain an insecure one.


Assuntos
Comunicação , Algoritmos , Inteligência Artificial
10.
Rev Argent Microbiol ; 49(1): 3-6, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28094064

RESUMO

Antibiotic resistance results in higher medical costs, prolonged hospital stays and increased mortality and is rising to dangerously high levels in all parts of the world. Therefore, this study aims to search for new antimicrobial agents through bioprospecting of extracts of endophytic fungi from Bauhinia guianensis, a typical Amazonian plant used in combating infections. Seventeen (17) fungi were isolated and as result the methanolic extract of the fungus Exserohilum rostratum showed good activity against the bacteria tested. The polyketide monocerin was isolated by the chromatographic technique, identified by NMR and MS, showing broad antimicrobial spectrum.


Assuntos
Anti-Infecciosos , Bauhinia , Bioprospecção , Anti-Infecciosos/farmacologia , Fabaceae , Fungos , Testes de Sensibilidade Microbiana
12.
J Clin Aesthet Dermatol ; 17(1): 33-40, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38298752

RESUMO

Background: The plasma jet is a non-surgical and minimally invasive procedure that acts by heating the superficial region of the skin, providing rejuvenation of the region. Objective: We sought to compare the clinical and histological effects of direct plasma jet versus electrocarbonization without plasma in the treatment of wrinkles in the upper palpebral region. Methods: This is a clinical trial in which 20 volunteers participated and divided into two groups: electrocarbonization (EG) and plasma jet (JPG), which were clinically evaluated before and after treatment through evaluation protocols, photographs, and questionnaires. Three treatment sessions were performed in the upper eyelid region with an interval of 30 days. After the treatment, a surgical procedure of upper blepharoplasty was performed on two volunteers to remove a skin fragment and later histological analysis. Results: The JPG showed better clinical responses in rejuvenation. The EG promoted an increase in the number of fibroblasts, the number of blood vessels and the amount of inflammation. The JPG showed an increase in the number of fibroblasts and blood vessels. It was observed that the JPG generated activation of T lymphocytes (CD3), macrophages (CD68), and plasmocytes (CD138); in addition to reducing the number of positive cells for CD57 (NK cells). The satisfaction analysis shows that 100 percent in the JPG considered themselves satisfied with the treatment. Conclusion: We verified that in comparison with electrocarbonization, the use of a direct plasma jet promoted tissue improvement at the histological level, in addition to fewer adverse reactions.

13.
Sci Rep ; 13(1): 5641, 2023 04 06.
Artigo em Inglês | MEDLINE | ID: mdl-37024631

RESUMO

An historical population-based cohort study was conducted aiming to estimate the incidence of cutaneous malignant melanoma in the South Region of Portugal between Jan 2016 and June 2017; to clinically characterize the diagnosed individuals; to describe instituted treatment; and to estimate survival outcomes. Data were extracted from a cancer registry (ROR-Sul) covering 4,800,000 inhabitants (46% of the Portuguese population) and included a total of 789 individuals meeting eligibility criteria. The crude incidence rate (18 months) of melanoma was 13.36/100,000 inhabitants and the Age-Standardized Incidence Rate per 100,000 World population was 9.65/100,000 inhabitants. The most common histological subtypes identified were superficial extension, followed by malignant melanoma and nodular melanoma. Most cases were diagnosed in stage I (50.39%), equally distributed by sex and with a median age of 65 years. During the study period, 174 recurrence events were recorded (23.45%) and recurrence-free survival rate was significantly lower in more advanced stages. Patients had a two-fold risk of recurrence/death when in presence of ulcerated tumors [adjusted hazard ratio (adj HR) = 2.28; 95% confidence interval (CI) 1.40-3.70]. Overall survival rate at 3-years was 80.54% (95% CI 77.58-83.15), higher than previous national reports, and considerably higher for individuals diagnosed at earlier stages (p < 0.001). We have also identified differential survival outcomes in stages II-III explained by the uptake of sentinel lymph node biopsy. The epidemiologic and clinical characteristics of malignant melanoma patients studied are consistent with international literature. The incidence and rates observed suggests additional public health campaigns are needed to modify behaviours of the Portuguese population and thus reduce their risk.


Assuntos
Melanoma , Neoplasias Cutâneas , Humanos , Idoso , Portugal/epidemiologia , Estudos de Coortes , Melanoma/patologia , Neoplasias Cutâneas/patologia , Biópsia de Linfonodo Sentinela , Melanoma Maligno Cutâneo
14.
J Clin Aesthet Dermatol ; 16(2): 19-23, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36909872

RESUMO

Background: High-intensity stationary therapeutic ultrasound (HITU) technology is gaining popularity as an attractive modality for treating different conditions, but little is known about its application in aesthetics. Objective: To analyze the effects of stationary unfocused ultrasound (HITU technology) in treating localized fat in women's abdominal region. Methods: The sample consisted of 43 women with localized abdominal adiposity, assessed pre and post-treatment by assessment protocols, adversity analysis questionnaires, ultrasound exams, and serum level exams. The volunteers were randomly divided into three subgroups: G-1, who used the device off, G-2 received therapy with the device once a week for two months (Parameters: Pulsed - 100Hz - 50% - 4.0 W/cm2 - 20 minutes) and the G-3 who used the device on twice a week for a month (Parameters: Pulsed - 100Hz - 50% - 3.2W/cm2 - 30 minutes). All groups received eight sessions in total. Results: There was a significant reduction for G-3 in the plicometry of the lower right region (p=0.01) in the comparison between the final and initial moments. In the comparison among the three research groups, there was a significant reduction in plicometry in the lower right (p=0.03) and left (p=0.02) regions in G3. Via ultrasound, a reduction in the fat layers average was observed in all groups. In G-3, there were significant differences in the left infraumbilical region (p=0.02) and right (p=0.04). In the group comparison, the right infraumbilical region showed significant differences (p=0.04) for the G-3. No differences were found for weight, BMI, body fat percentage and supra, infra and umbilical perimetry (p>0.05). The adverse reactions reported were: Mild hyperaemia (75%) and sensation of shock (21%), there were also reports of improvement in fluid retention in 93.7 percent of the volunteers, and most were satisfied with the result. Conclusion: Both treatment protocols for the reduction of localized adiposity were effective compared to the placebo group, with a significant reduction in the use of ultrasound and plicometry in the concentration of fat in the lower abdominal region.

15.
Front Health Serv ; 3: 1190357, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38116534

RESUMO

Objectives: The current European crisis in human resources in health has opened the debate about working conditions and fair wages. This is the case with Resident doctors, which have faced challenges throughout Europe. In Portugal, they account for about a third of the doctors in the Portuguese National Health Service. No studies to date objectively demonstrate the working conditions and responsibilities undertaken. This study aims to quantify the residents' workload and working conditions. Methods: Observational, retrospective cross-sectional study which involved a survey on the clinical and training activity of Portuguese residents, actively working in September 2020. The survey was distributed through e-mail to residents' representatives and directly to those affiliated with the Independent Union of Portuguese Doctors. The descriptive analysis assessed current workload, and logistic regression models analyzed associations with geographical location and residency seniority. Results: There were a total of 2,012 participants (19.6% of invited residents). Of the residents giving consultations, 85.3% do so with full autonomy. In the emergency department, 32.1% of the residents work 24 h shifts and 25.1% work shifts without a specialist doctor present. Regarding medical training, 40.8% invest over EUR 1,500 annually. Autonomy in consultations was associated with being a Family Medicine resident (OR 4.219, p < 0.001), being a senior resident (OR 5.143, p < 0.001), and working in the Center (OR 1.685, p = 0.009) and South regions (OR 2.172, p < 0.001). Seniority was also associated with investing over EUR 1,500 in training annually (OR 1.235, p = 0.021). Conclusion: Residents work far more than the contracted 40 h week, often on an unpaid basis. They present a high degree of autonomy in their practice, make a very significant personal and financial investment in medical training, with almost no time dedicated to studying during working hours. There is a need to provide better working conditions for health professionals, including residents, for the sake of the sustainability of health systems across Europe.

16.
Blood Adv ; 7(22): 7045-7055, 2023 11 28.
Artigo em Inglês | MEDLINE | ID: mdl-37738090

RESUMO

Hodgkin lymphoma (HL) has become 1 of the most curable cancers. Therefore, rigorous assessment of health-related quality of life (HRQoL) and symptom burden of these patients is essential to support informed clinical decisions. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group previously developed the EORTC Quality of Life Questionnaire (QLQ) Hodgkin Lymphoma 27. This paper reports the final results of an international study by the EORTC group to develop a HRQoL disease-specific measure for these patients: the EORTC QLQ-HL27. Patients with a confirmed diagnosis of HL (N = 381) were enrolled from 12 countries and completed the EORTC QLQ-C30, QLQ-HL27, and a debriefing questionnaire at baseline (any time after diagnosis). A subset completed a retest (n = 126) or responsiveness-to-change analyses (RCA) second measurement (n = 98). Psychometrics were evaluated. Confirmatory factor analysis showed an acceptable fit of the 27 items of the QLQ-HL27 on its 4 scales (symptom burden, physical condition/fatigue, emotional impact, and worries about health/functioning). Test-retest reliability, convergent validity, known-group comparisons, and RCA find satisfactory results. Symptom burden and fatigue was higher among patients on treatment (with 36%-83% reporting at least a few problems) compared with those who had completed treatment (19%-61% reporting at least a few problems). Prevalence of worries about health and functioning (reporting at least some worry) was similar for patients on treatment (51%-81%) vs those who had completed treatment (52%-78%). Implementation of the EORTC QLQ-HL27 in research and clinical applications will increase sensitivity of HRQoL assessment in patients with HL. High quality data generated through use of this questionnaire are expected to facilitate clinical decision making in the HL setting.


Assuntos
Doença de Hodgkin , Qualidade de Vida , Humanos , Qualidade de Vida/psicologia , Doença de Hodgkin/diagnóstico , Doença de Hodgkin/terapia , Reprodutibilidade dos Testes , Inquéritos e Questionários , Fadiga/etiologia
17.
Front Med (Lausanne) ; 9: 968272, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36035431

RESUMO

Introduction: Cancer and corresponding available treatments are associated with substantial symptoms and functional limitations. In this context, collection of patient-reported outcomes (PRO) in clinical trials gained special interest and is recommended by regulatory authorities. Within clinical trials framework, PRO may provide evidence to support medicines approval, labeling and marketing claims. This study aims to analyze the existing evidence based on PRO as part of new oncology indications receiving positive opinions issued by the European Medicines Agency (EMA) between 2017 and 2020 and to identify PRO related label claims granted. Methodology: Oncology medicinal products and indications approved by the European Commission following a positive opinion from the EMA between 2017 and 2020 were identified. European Public Assessment Report (EPAR) and Summary of Product Characteristics (SmPC) were reviewed for each medicinal product to identify use of PRO and PRO label claims. Results: A total of 128 oncology indications, corresponding to 76 medicines, were approved; of those, 100 (78.1%) included PRO in the confirmatory clinical trials. Thirty-seven indications were supported by double-blind randomized trials and the remainder 63 by open-label trials. Out of the 104 confirmatory trials analyzed, PRO were defined as a secondary endpoint in 60 studies (57.7%), exploratory in 31 (29.8%) and as both in 13 (12.5%). In total, 54 different PRO measures (PROM) were used, of those 41 (75.9%) were disease-specific measures. Nevertheless, PROM selected relied on the EORTC (41.3%), FACIT (17.1%) and EQ-5D (29.2%) measures. A total of 76 indications (59.4%) had PRO reviewers comments included in the EPAR, however only 22 indications (17.8%) included label claims in the SmPC. The reasons identified in the EMA assessment supporting the exclusion of PRO claims were described for 34 indications (44.7%). Conclusions: Despite growing recognition of the value of PRO data for the development of improved cancer therapies, PRO implementation remains challenging. The main reasons identified in our study are related with study design, missing data, study conduct and PROM selection.

18.
J Clin Aesthet Dermatol ; 15(1): E66-E71, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35309273

RESUMO

Background: The mechanism of fat reduction from radiofrequency occurs via the thermal stimulation of adipocyte metabolism, causing a lipase-mediated triglyceride enzyme degradation, apoptosis, and adipocyte rupture. Ultracavitation promotes fat reduction using adipose cell destruction through mechanical stimulus. The literature on the combination of these two physical agents, named ultrafrequency, is still scarce and requires consistent analysis of the effects of this therapy combination. Objective: The objective of this study was to investigate the effects of radiofrequency associated with ultracavitation in the treatment of abdominal subcutaneous tissue of women. Methods: This was a prospective, randomized clinical trial in which 45 participants were divided into three distinct groups: the control group (no treatment); ultracavitation group; and ultracavitation and radiofrequency (UCV+RF) group, each with 15 volunteers. The following variables were evaluated: weight, perimetry, plicometry, ultrasonography, treatment reactions, and patient satisfaction. Results: The participants in the UCV+RF group presented a more significant decrease in adipose tissue, which was verified through all the evaluation methods. Conclusion: Based on our results, the simultaneous application of ultracavitation and radiofrequency generated a reduction in localized adiposity superior to the isolated use of ultracavitation.

19.
Breast ; 62: 135-143, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35182993

RESUMO

BACKGROUND: Real-world (RW) data may provide valuable information on the effectiveness and safety of medicines, which is particularly relevant for clinicians, patients and third-party payers. Evidence on the effectiveness of palbociclib plus fulvestrant is scarce, which highlights the need of additional studies. The aim of this study was to evaluate the effectiveness of palbociclib plus fulvestrant in advanced breast cancer (ABC). MATERIALS AND METHODS: We conducted a population-based retrospective cohort study and cases of interest were identified through the Portuguese National Cancer Registry database and additional data sources. Patients aged≥18 years, diagnosed with ABC and exposed to palbociclib plus fulvestrant between May 31, 2017 and March 31, 2019 were included. Patients were followed-up until death or cut-off date (February 28, 2021). Primary outcome was rw-progression-free survival (rwPFS). Secondary outcomes were rw-overall survival (rwOS), rw-time to palbociclib failure (rwTPF) and rw-time to next treatment (rwTTNT). RESULTS: A total of 210 patients were included. Median age was 58 years (range 29-83) and 99.05% were female. Median follow-up time was 23.22 months and, at cut-off date, treatment had been discontinued in 189 patients, mainly due to disease progression (n = 152). Median rwPFS was 7.43 months (95% confidence interval [CI] 6.28-9.05) and 2-year rwPFS was 16.65% (95%CI 11.97-22.00). Median rwOS was 24.70 months (95%CI 21.58-29.27), median rwTPF was 7.5 months (95%CI 6.51-9.08) and median rwTTNT was 11.74 months (95%CI 10.33-14.08). CONCLUSION: Palbociclib plus fulvestrant seems an effective treatment for ABC in real-world context. Compared to registrations studies, rwPFS and rwOS were shorter in real-life setting.


Assuntos
Neoplasias da Mama , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/etiologia , Estudos de Coortes , Feminino , Fulvestranto , Humanos , Pessoa de Meia-Idade , Piperazinas , Piridinas , Receptor ErbB-2 , Estudos Retrospectivos
20.
PLoS One ; 16(10): e0258423, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34624053

RESUMO

BACKGROUND: Chronic lymphocytic leukaemia (CLL) is the most common leukaemia among adults in western countries. Considering the increasing incidence and prevalence of this condition, it is highly relevant to better characterise these patients in Portugal, where data is still scarce. METHODS: To determine incidence, clinical presentation, survival and second malignancies, a population-based historical cohort study was conducted. Cases of interest were identified through the South Region Cancer Registry database and additional data sources. Patients aged ≥18 years, with a confirmed diagnosis of CLL or small lymphocytic lymphoma between January 1st, 2013 and December 31st, 2014 were included. Patients were followed-up until death or cut-off date (December 31st, 2019). RESULTS: A total of 496 patients were included and median follow-up time was 5.46 years. Crude incidence rates were 5.03 and 5.22 per 100,000 inhabitants for 2013 and 2014, respectively, and age-adjusted incidence rates were 3.18:100,000 European population for 2013 and 3.35:100,000 European population for 2014. Median age at diagnosis was 71 years and the male/female ratio was 1.40. The majority of patients had leukemic presentation of the disease (86.09%), was diagnosed in Binet stage A (75.58%) and did not present B symptoms (84.01%), anaemia (haemoglobin ≤10g/dL; 90.63%) nor thrombocytopenia (platelet count ≤100 000/µL; 91.73%). Five-year overall survival (OS) rate was 70.53% (95%CI 66.31-74.34) and age, lactate dehydrogenase, Binet stage and a ≥5 Charlson comorbidity index score were independently associated with OS. Standardised-incidence ratios for any second malignancy and cutaneous squamous cell carcinoma were 1.59 (95%CI 1.19-2.08) and 10.15 (95%CI 6.28-15.51), respectively. CONCLUSION: Incidence, clinical presentation and survival of CLL Portuguese patients are similar to those reported for other western countries. The increased risk of second malignancies raises concerns and needs adequate clinical watchfulness.


Assuntos
Leucemia Linfocítica Crônica de Células B , Adolescente , Adulto , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Portugal , Adulto Jovem
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