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Necrotizing fasciitis is a rapidly progressive soft tissue infection extending from the skin to the fascia, resulting in extensive necrosis. It is a very rare but serious complication, with mortality ranging from 10 to 15%. Optimal management involves early diagnosis followed by treatment combining antibiotic therapy and wide surgical removal as soon as possible. Localisation in the breast is uncommon. Although most cases are primary necrotizing fasciitis of the breast, several cases of necrotizing fasciitis have been reported in the post-operative aftermath of breast surgery. We present a case of necrotizing fasciitis of the breast following submammary mastectomy with immediate reconstruction using a pre-pectoral silicone implant, which resulted in multiple organ failure and the death of the patient despite optimal medical and surgical management. This is the first case to occur after immediate breast reconstruction.
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INTRODUCTION: Colorectal cancer survivors have many problems affecting their quality of life (QOL). Traditional follow-up focuses on the detection of recurrence rather than QOL. Efforts are being made to assess patient-reported outcomes (PROMS) more formally. Such changes may enable patients to consider QOL factors when deciding on treatment. METHODS: Patients who underwent laparoscopic surgery for rectal cancer between 2005 and 2015 at a single institution were identified and sent European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR29 QOL questionnaires. QOL and the impact of radiotherapy, chemotherapy and formation of end colostomy were assessed. RESULTS: Some 141 patients were identified: 12 died and 118 (83.7%) responded, of whom 101 completed the questionnaires and 17 declined to participate; 11 were lost to follow-up. Mean age was 67 years, median follow-up was 58 months. Median QOL score was 6 (maximum 7) and 4.5% of patients reported a poor QOL score (<4). Significant rectal/perianal pain, sexual dysfunction and urinary symptoms were reported in 3.6%, 10.9% and 2.7% of respondents, respectively. Significant differences between treatment groups were uncommon. All cohorts reported similar QOL, functional and symptom scores. CONCLUSIONS: These results compare favourably with the published data. Future studies may benefit from baseline assessment to better assess treatment impact, prescient in an increasingly elderly and comorbid population. This paper establishes that good PROMs are achievable with laparoscopic surgery for rectal cancer. It identifies limited differences in QOL between treatment modalities. Restoration of intestinal continuity and end colostomy result in similar QOL. This may address common concerns regarding stomata, sexual function and low anterior resection syndrome in this cohort.
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Sobreviventes de Câncer , Laparoscopia , Neoplasias Retais , Humanos , Idoso , Neoplasias Retais/cirurgia , Qualidade de Vida , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Síndrome , Laparoscopia/efeitos adversos , Laparoscopia/métodos , Sobreviventes , Medidas de Resultados Relatados pelo Paciente , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Patients with advanced non-small-cell lung cancer (NSCLC) treated with immune checkpoint blockers (ICBs) ultimately progress either rapidly (primary resistance) or after durable benefit (secondary resistance). The cancer vaccine OSE2101 may invigorate antitumor-specific immune responses after ICB failure. The objective of ATALANTE-1 was to evaluate its efficacy and safety in these patients. PATIENTS AND METHODS: ATALANTE-1 was a two-step open-label study to evaluate the efficacy and safety of OSE2101 compared to standard-of-care (SoC) chemotherapy (CT). Patients with human leukocyte antigen (HLA)-A2-positive advanced NSCLC without actionable alterations, failing sequential or concurrent CT and ICB were randomized (2 : 1) to OSE2101 or SoC (docetaxel or pemetrexed). Primary endpoint was overall survival (OS). Interim OS futility analysis was planned as per Fleming design. In April 2020 at the time of interim analysis, a decision was taken to prematurely stop the accrual due to coronavirus disease 2019 (COVID-19). Final analysis was carried out in all patients and in the subgroup of patients with ICB secondary resistance defined as failure after ICB monotherapy second line ≥12 weeks. RESULTS: Two hundred and nineteen patients were randomized (139 OSE2101, 80 SoC); 118 had secondary resistance to sequential ICB. Overall, median OS non-significantly favored OSE2101 over SoC {hazard ratio (HR) [95% confidence interval (CI)] 0.86 [0.62-1.19], P = 0.36}. In the secondary resistance subgroup, OSE2101 significantly improved median OS versus SoC [11.1 versus 7.5 months; HR (95% CI) 0.59 (0.38-0.91), P = 0.017], and significantly improved post-progression survival (HR 0.46, P = 0.004), time to Eastern Cooperative Oncology Group (ECOG) performance status deterioration (HR 0.43, P = 0.006) and Quality of Life Questionnaire Core 30 (QLQ-C30) global health status compared to SoC (P = 0.045). Six-month disease control rates and progression-free survival were similar between groups. Grade ≥3 adverse effects occurred in 11.4% of patients with OSE2101 and 35.1% in SoC (P = 0.002). CONCLUSIONS: In HLA-A2-positive patients with advanced NSCLC and secondary resistance to immunotherapy, OSE2101 increased survival with better safety compared to CT. Further evaluation in this population is warranted.
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COVID-19 , Vacinas Anticâncer , Carcinoma Pulmonar de Células não Pequenas , Neoplasias Pulmonares , Humanos , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Vacinas Anticâncer/efeitos adversos , Antígeno HLA-A2/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/etiologia , Qualidade de Vida , Resultado do Tratamento , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , COVID-19/etiologia , ImunoterapiaRESUMO
This study comprises a critical review of modeling of pesticides in surface waters. The aim was to update the status of the use of models to simulate the fate of pesticides from diffuse sources. ISI papers were selected on Scopus and the information concerning the study areas, type of pesticides (herbicides, fungicides and insecticides), the model, and the methodology adopted (i.e., calibration and/or validation, spatial and temporal scales) were analyzed. The studies were carried out in Europe (55.5%), North America (22.3%), Asia (13.9%) and South America (8.3%). The Soil and Water Assessment Tool proved to be the most used model (45.95%). Herbicides were the most modeled pesticides (71.4%), followed by insecticides (18.2%) and fungicides (10.4%). The main herbicides modeled were atrazine, metolachlor, isoproturon, glyphosate, and acetochlor. Insecticides such as chlorpyrifos and metaldehyde. Chlorothalonil, and fungicides (i.e., tebuconazole) were the most widely investigated. Based on published studies, it was found that modeling approaches for assessing the fate of pesticides are constantly evolving and the model algorithms work well with diverse watershed conditions, management strategies, and pesticide properties. Several papers reported concentrations of pesticides exceeding ecotoxicological thresholds revealing that water contamination with pesticides used in agriculture and urban areas is a priority issue of current global concern.
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Fungicidas Industriais , Herbicidas , Inseticidas , Praguicidas , Poluentes Químicos da Água , Praguicidas/análise , Fungicidas Industriais/análise , Inseticidas/análise , Monitoramento Ambiental/métodos , Água Doce , Herbicidas/análise , Agricultura , Água , Poluentes Químicos da Água/análiseRESUMO
BACKGROUND: Cognitive composites commonly serve as primary outcomes in Alzheimer's disease (AD) secondary prevention trials. OBJECTIVE: To evaluate the association between amyloid (Aß) burden level (+/-) and performance on three separate composite endpoints: Preclinical Alzheimer's Cognitive Composite (PACC), PACC+Semantic Fluency (PACC5), and Repeatable Battery for Neuropsychological Status (RBANS). DESIGN: Screening data from the randomized, double-blind, placebo-controlled, phase 2b/3 atabecestat EARLY study in preclinical AD participants were used in this analysis. SETTING: The EARLY study was conducted at 143 centers across 14 countries. PARTICIPANTS: 3,569 cognitively unimpaired older adults (Clinical Dementia Rating of 0; aged 60-85 years) screened for inclusion in the EARLY study with Aß status and at least PACC or RBANS at screening were included. Participants were categorized as those with non-pathological Aß levels (Aß-, n=2,824) and those with pathological Aß levels (Aß+, n=745) based on florbetapir uptake or levels of cerebrospinal fluid Aß1-42. MEASUREMENTS: Analysis of Covariance models controlling for age, sex, and education were used to examine the difference in PACC, PACC5, and RBANS between Aß groups. Nonparametric bootstrap was used to compare sensitivity of composites to differentiate between Aß status. RESULTS: Of 3,569 participants, 2,116 were women (59%); 3,006 were Caucasian (84%); mean (SD) age was 68.98 (5.28) years. Aß+ participants performed worse versus Aß- participants on all cognitive composites though the magnitude of the Aß effect was generally small. The Aß+/- effect size for the PACC (Cohen's d=-0.15) was significantly greater than the RBANS (d=-0.097) while the PACC5 effect size (d=-0.139) was numerically larger than the RBANS. When examining subscores from the composites, memory tests (i.e., Free and Cued Selective Reminding Test, Figure Recall) and speed of processing (i.e., Digit-Symbol/Coding on the PACC/RBANS) exhibited the largest Aß+/- effect sizes. CONCLUSIONS: Cross-sectional relationships between Aß and cognition among clinically unimpaired older adults are detectable on multi-domain cognitive composites but are relatively small in magnitude. The Aß+/- group effect was statistically larger for PACC and marginally larger for PACC5 versus RBANS. However, interpretation of composite sensitivity to Aß status cross-sectionally cannot be generalized to sensitivity to change over time.
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Doença de Alzheimer , Tiazinas , Idoso , Doença de Alzheimer/tratamento farmacológico , Amiloide , Peptídeos beta-Amiloides/líquido cefalorraquidiano , Cognição , Feminino , Humanos , Masculino , Testes Neuropsicológicos , Piridinas , Ensaios Clínicos Controlados Aleatórios como Assunto , Tiazinas/uso terapêuticoRESUMO
ABSTRACT: Objectives. Atrial fibrillation (AF) is a clinically relevant supra-ventricular arrhythmia which represents an independent risk factor for development of heart failure and ischemic stroke. The present study aims at the investigation of the possible clinical role of the soluble sST2 biomarker to evaluate the fibrosis in a group of patients with first diagnosed or permanent AF. The possible association with the left atrium size is also studied. Materials and Methods. The serum concentrations of the biomarker have been measured in a group of 58 patients (mean age 83.6 ± 6.0 years) and 40 individuals, assumed healthy and without AF, constituted the control group. The analysis is carried out by means of a high-sensitivity enzyme-linked immunosorbent assay. Results. The mean concentration of sST2 is 26.1 (22.7-30.5) ng/mL in the AF group, while in the control is 17.3 (15.7-18.9) ng/mL. Remarkable differences have been obtained for the two subsets with first diagnosed (23 (21.2-24) ng/mL) and permanent AF (30.5 (28.6-32) ng/mL). The analysis has been completed with a trans thoracic echocardiographic exam to evaluate the left atrium size and the left ventricular ejection fraction. Conclusions. The sST2 serum concentrations are found to be higher in the permanent AF with respect to the cases where the AF is of new onset or follow a paroxysmal pattern. The results support the adoption of the marker to evaluate the degree of fibrosis related to the left atrium of fibrillating patients. A positive association has been proved between the left atrium size and the sST2 concentrations.
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Fibrilação Atrial/sangue , Fibrilação Atrial/patologia , Proteína 1 Semelhante a Receptor de Interleucina-1/sangue , Idoso , Idoso de 80 Anos ou mais , Biomarcadores , Estudos de Casos e Controles , Feminino , Fibrose , Humanos , Masculino , Volume Sistólico , Função Ventricular EsquerdaRESUMO
PURPOSE: The main objective of this work is to investigate hemodynamics phenomena occurring in EVAS (Endo Vascular Aneurysm Sealing), to understand if and how they could lead to type 1a endoleaks and following re-intervention. To this aim, methods based on computational fluid mechanics are implemented as a tool for checking the behavior of a specific EVAS configuration, starting from the post-operative conditions. Pressure and velocity fields are detailed and compared, for two configurations of the Nellix, one as attained after correct implantation and the other in pathological conditions, as a consequence of migration or dislocation of endobags. METHODS: The computational fluid dynamics (CFD) approach is used to simulate the behavior of blood within a segment of the aorta, before and after the abdominal bifurcation. The adopted procedure allows reconstructing the detailed vascular geometry from high-resolution computerized tomography (CT scan) and generating the mesh on which the equations of fluid mechanics are discretized and solved, in order to derive pressure and velocity field during heartbeats. RESULTS: The main results are obtained in terms of local velocity fields and wall pressures. Within the endobags, velocities are usually quite regular during the whole cardiac cycle for the post-implanted condition, whereas they are more irregular for the migrated case. The largest differences among the two cases are observed in the shape and location of the recirculation region in the rear part of the aorta and the region between the endobags, with the formation of a gap due to the migration of one or both of the two. In this gap, the pressure fields are highly different among the two conditions, showing pressure peaks and pressure gradients at least four times larger for the migrated case in comparison to the post-implanted condition. CONCLUSIONS: In this paper, the migration of one or both endobags is supposed to be related to the existing differential pressures acting in the gap formed between the two, which could go on pushing the two branches one away from the other, thus causing aneurysm re-activation and endoleaks. Regions of flow recirculation and low-pressure drops are revealed only in case of endobag migration and in presence of an aneurysm. These regions are supposed to lead to possible plaque formation and atherosclerosis.
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Aneurisma da Aorta Abdominal , Implante de Prótese Vascular , Procedimentos Endovasculares , Aneurisma da Aorta Abdominal/diagnóstico por imagem , Aneurisma da Aorta Abdominal/cirurgia , Prótese Vascular , Implante de Prótese Vascular/efeitos adversos , Procedimentos Endovasculares/efeitos adversos , Humanos , Hidrodinâmica , Desenho de Prótese , StentsRESUMO
The paper presents the results of the analysis of the geo-chemo-mechanical data gathered through an innovative multidisciplinary investigation campaign in the Mar Piccolo basin, a heavily polluted marine bay aside the town of Taranto (Southern Italy). The basin is part of an area declared at high environmental risk by the Italian government. The cutting-edge approach to the environmental characterization of the site was promoted by the Special Commissioner for urgent measures of reclamation, environmental improvements and redevelopment of Taranto and involved experts from several research fields, who cooperated to gather a new insight into the origin, distribution, mobility and fate of the contaminants within the basin. The investigation campaign was designed to implement advanced research methodologies and testing strategies. Differently from traditional investigation campaigns, aimed solely at the assessment of the contamination state within sediments lying in the top layers, the new campaign provided an interpretation of the geo-chemo-mechanical properties and state of the sediments forming the deposit at the seafloor. The integrated, multidisciplinary and holistic approach, that considered geotechnical engineering, electrical and electronical engineering, geological, sedimentological, mineralogical, hydraulic engineering, hydrological, chemical, geochemical, biological fields, supported a comprehensive understanding of the influence of the contamination on the hydro-mechanical properties of the sediments, which need to be accounted for in the selection and design of the risk mitigation measures. The findings of the research represent the input ingredients of the conceptual model of the site, premise to model the evolutionary contamination scenarios within the basin, of guidance for the environmental risk management. The study testifies the importance of the cooperative approach among researchers of different fields to fulfil the interpretation of complex polluted eco-systems.
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BACKGROUND: The aim of the study is the use of Integra® dermal regeneration template (DRT) in scalp reconstruction after tumor resection by comparing results of literature and Gustave Roussy Institut' series of 20 patients. MATERIEL AND METHODS: A systematic review, with a PubMed search was performed using the following key words "artificial dermis OR DRT" AND "scalp". Eligible articles were selected to study patients and defects characteristics, operative modalities, and the follow up results. This case series presents the experience of immediate DRT reconstruction after scalp full thickness carcinologic surgery, in the plastic surgery service of Gustave Roussy cancer center. RESULTS: Twenty patients with primary scalp tumors underwent two steps DRT reconstruction for full thickness scalp defect. The mean surface defect was 72cm2. The mean operative combined time was 94min, with a total healing delay of 68 days. All patients successfully recovered. Five patients had minor complications (3 delayed healing and 2 DRT infections) with no need of additional surgery. Fourteen articles, totalizing n=210 patients, were included and reviewed. Reported ages ranged from 58 to 82 years old. Almost all patients were operated for oncologic resections. The mean surface defect was 73cm2. The mean follow-up was 15 months. The skin graft taking rates ranged from 95% up to 100%. CONCLUSION: In large scalp full thickness defects after cancer resection, DRT appears to be a suitable reconstruction option for patients with comorbidities, and aggressive tumors. This technique allows immediate coverage of the calvarium with short operative time and prevents from healing delay. The oncologic follow-up is no disturbed and cancer recurrences are easily diagnosed.
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Sulfatos de Condroitina , Couro Cabeludo , Idoso , Idoso de 80 Anos ou mais , Colágeno , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Couro Cabeludo/cirurgia , Transplante de PeleRESUMO
OBJECTIVE: Phytotherapic treatment as Cernilen-flogo® is commonly used to treat chronic pelvic pain, chronic prostatitis, and BPE (benign prostatic enlargement). In our study, for the first time, we aim to evaluate postoperatively Cernilen-flogo® therapy in patients with BPE/LUTS (lower urinary tract symptoms) previously treated with Greenlight laser XPS (180W) photovaporization of prostate (PVP) to improve surgical outcomes. MATERIALS AND METHODS: We collected data from patients treated with PVP for BPE/LUTS international prostate symptom score (IPSS) >20 unresponding to conventional treatment. Two groups of patients were analyzed: Group A including 15 patients (50%) treated postoperatively with Cernilen-flogo® vs. no treatment Group B. One expert surgeon performed all the procedures. RESULTS: 30 patients included with BPE/LUTs previously treated with PVP. There was no difference between patients' demographic, median age, prostate volume and PSA (prostate specific antigen) level. All patients had a postoperative evaluation after 30-45 days. Patients with postoperative complications (acute urinary retention, postoperative hematuria) were excluded from our study. All patients had a preoperative and postoperative evaluation of IPSS, bother score (BS) and pelvic discomfort (visual analogic scale VAS). Preoperatively there was no significative difference in IPSS, BS and VAS. IPSS Group A was postoperatively 7.13 (SD 1.64) and Group B was 7.33 (SD 1.58) (p=0.67); BS Group A was postoperatively 1.33 (SD 0.81), Group B was 1.73 (SD 1.09) (p=0.30), and VAS Group A was 2.73 (SD 1.9) and Group B was 4.33 (SD 1.58) (p=0.004) showing a statistically significative difference between the two groups in pelvic discomfort with a better outcome in patients treated with Cernilen-flogo®. CONCLUSIONS: Our study showed that Cernilen-flogo® treatment after PVP is effective and minimize patient's pelvic discomfort showed by lower VAS level resulting in better postoperatively patient's quality of life (QOL).
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Terapia a Laser , Sintomas do Trato Urinário Inferior/cirurgia , Hiperplasia Prostática/cirurgia , Humanos , Masculino , Medidas de Resultados Relatados pelo Paciente , Qualidade de VidaRESUMO
INTRODUCTION: Cholecystoenteric fistula is a rare and late complication of cholelithiasis. The clinical presentation is mostly chronic and is not distinguishable from the dyspeptic symptoms of non-complicated cholelithiasis. For this reason, the preoperative diagnosis is difficult and uncertain, and it is often made up primarily intraoperatively and incidentally during cholecystectomy. In this article, we report a case of cholecystocolonic fistula management by laparoscopic approach. PRESENTATION OF CASE: We studied a 64 years old male patient with fever of an unknown origin for two months and abdominal pain. He underwent a contrast enhanced CT abdominal scan that showed a sclerotic gallbladder with a disorganized fluid collection. The colonoscopy identified a cholecystocolonic fistula with hepatic flexure. A laparoscopic cholecystectomy was performed to repair the colonic wall with intra-corporeal sutures. DISCUSSION: Thanks to the advancements in CT scan's resolution and the application of endoscopic technology such as ERCP or colonscopy, preoperative diagnosis of cholecystoenteric fistula has been greatly improved. In addition, cholecystoenteric fistula has been successfully managed laparoscopically with laparoscopic cholecystectomy and closure of the fistula tract. CONCLUSION: The laparoscopic management of cholecystoeneteric fistula is a feasible and safe procedure but the operative strategy should be individualized on diagnosis, patient characteristics, availability of resources and experience of surgical team.
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In the field of photodynamic therapy (PDT), optimization of the in vivo therapeutic efficacy needs a comprehensive study of the photo-killing action spectrum that depends on both the photosensitizer (PS) absorption and the tissue optical properties. This is especially true in the case of gastric infections by Helicobacter pylori: PS absorption has been largely investigated in vitro, while the contribution of tissue optical properties and illumination geometry has been poorly studied, despite being parameters that reflect the specific in vivo conditions. To investigate their influence, we focussed on the case of a point-like light source positioned in the antrum. This models a therapeutic device developed by our team which consists of a LED-based ingestible pill. By a simple 3D illumination model, our approach mediates light-tissue interaction over the illuminated stomach wall surface, then calculates its average transmittance T by means of a 1D model representative of the mean gastric mucosa structure. Finally, by merging T(λ) with the photosensitizers' absorption we obtained the in vivo action spectrum. This shows two peaks at about 500 and 630 nm, indicating a noticeable influence of the tissue with respect to in vitro studies, where the action spectrum reflects PS absorption only. Our approach defines one average action spectrum for this specific therapeutic context, which reflects the need to choose one emission spectrum for the light source used. The proposed methodology could be applied to any other illumination geometry of cave organs, provided appropriate model modifications for the light source and tissue characteristics are made.
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Antibacterianos/farmacologia , Mucosa Gástrica/efeitos dos fármacos , Infecções por Helicobacter/tratamento farmacológico , Helicobacter pylori/efeitos dos fármacos , Fotoquimioterapia , Fármacos Fotossensibilizantes/farmacologia , Mucosa Gástrica/microbiologia , Infecções por Helicobacter/microbiologia , Humanos , Testes de Sensibilidade MicrobianaRESUMO
In the pig industry, labour efficiency and animal welfare have become two of the most important factors for achieving technical goals and farming competitiveness. Blood sampling is one of the most common sample-collecting techniques, but routine on-field blood collection can be very demanding for farm operators and the welfare of the animals, in particular for lactating sows. The aim of this study was to describe and investigate the mammary vein as a novel means of blood access in lactating sows that does not require coercive restraint. The study involved a total of 68 sows: 34 animals were sampled from the jugular vein (Group J) and the other 34 sows from the mammary vein (Group M). Labour time and indicators of the sow welfare (vocalizations during collection and serum cortisol concentration in the 30min after the procedure) were collected from the two groups. The total amount of labour required, calculated as the time employed to perform blood collection multiplied by the number of operators involved in performing the technique (one for Group M and two for Group J, one for restraint and one for sampling), was significantly lower in Group M than Group J (Group M, 39.83±29.45s; Group J, 82.73±55.34s; P<0.001). Mean blood volume collected at T0 was 4.81±2.00mL and 4.84±1.73mL in Group J and Group M, respectively (P>0.05). The percentage of sows that vocalized in Group M was less than in Group J (2.94% vs. 94.12%; P<0.001). Serum cortisol concentrations were not statistically different between the two groups (P>0.05). The present study suggests greater efficiency in terms of saving labour time and reducing sow vocalization during blood collection with the use of mammary vein access compared with jugular vein access.
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Coleta de Amostras Sanguíneas/veterinária , Suínos/sangue , Bem-Estar do Animal , Animais , Coleta de Amostras Sanguíneas/métodos , Feminino , Veias Jugulares , Lactação , Glândulas Mamárias Animais/irrigação sanguínea , VeiasRESUMO
Introduction: Orphan diseases are low-prevalence conditions with chronically debilitating or life-threatening consequences. Their treatments are generally called orphan drugs (OD). Health-technology assessment processes have traditionally considered cost-effectiveness analysis (CEA), when making reimbursement and pricing decisions for health-care plans. Valuing OD with standard CEA raises important issues due to uncertain evidence, inability to meet cost-effectiveness thresholds for reimbursement and high budget impact, among others. Multi-criteria decision analysis (MCDA) allows to overcome these issues and improve the technical and ethical quality of decisions regarding prioritization, coverage, and reimbursement of OD. Areas covered: A scoping review was conducted in order to characterize MCDA frameworks for assessing OD and implementation experiences. We reviewed electronic databases (Medline, Embase, Cochrane Library, EBSCO, CINAHL, EconLit, Web of Science, LILACS, Google Scholar) key journals (Orphanet Journal of Rare Diseases and Value in Health) and organization repositories. Expert opinion: The theoretical framework for MCDA considers areas related to characteristics of orphan diseases and their technologies' clinical and economic impact. Participation processes are critical in incorporating societal values in weighting different dimensions and constructing decision rules. Local implementation pilots considering different stakeholders are necessary in order to pinpoint specific barriers and opportunities.
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Técnicas de Apoio para a Decisão , Produção de Droga sem Interesse Comercial/métodos , Doenças Raras/tratamento farmacológico , Orçamentos , Análise Custo-Benefício , Tomada de Decisões , Humanos , Produção de Droga sem Interesse Comercial/economia , Doenças Raras/economia , Mecanismo de Reembolso , Avaliação da Tecnologia Biomédica/métodosRESUMO
PURPOSE: Mesh fixation and broad overlap represent an open issue in umbilical hernia repair. A proprietary-designed implant with tentacle straps at its boundary has been developed to ensure a suture-free repair and a broader coverage of the abdominal wall. The study describes the results of umbilical hernia procedures carried out with the tentacle-shaped implant and the related surgical technique. METHODS: A proprietary tentacle-shaped flat mesh having a central body with integrated radiating arms at its edge was used to repair large umbilical hernias in 62 patients. The implant was placed in preperitoneal sublay. The friction of the straps, crossing the abdominal wall thanks to a special needle passer, was intended to assure adequate grip to hold the implant in place assuring a fixation-free procedure and broad overlap of the hernia defect. RESULTS: In a mean follow-up of 48 months (range 10-62 months), 4 seromas and 2 ischemia of the navel skin occurred. No infections, hematomas, chronic pain, mesh dislocation, or recurrence has been reported. CONCLUSIONS: The tentacle strap system of the prosthesis effectively ensured an easier implant placement avoiding the need for suturing the mesh. The arms of the implant ensured a proper orientation and stabilization of the mesh in association with a broad defect overlap. The specifically developed surgical procedure showed a quick postoperative recovery, a very low complication rate, and no recurrences even in the long term.
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Hérnia Umbilical/cirurgia , Herniorrafia/métodos , Próteses e Implantes , Telas Cirúrgicas , Parede Abdominal/cirurgia , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Implantação de Prótese/métodos , Recidiva , Técnicas de Sutura , Umbigo/cirurgiaRESUMO
Immunoglobulin-mediated suppression of immune checkpoint pathways may lead to a considerable activation of host immune responses against malignancies. Substantial therapeutic benefits were reported among patients who participated in cancer immunotherapy clinical trials which utilized monoclonal antibodies against cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), programmed cell death protein 1 (PD-1) and programmed cell death 1 ligand 1 (PD-L1). In a subsequent stage, immune checkpoint inhibitors were used in various clinical trials in combination with other therapeutic agents, such as immunomodulatory factors, chemotherapeutics, oncolytic viruses and radiation therapy. Interestingly, local antitumor interventions based either on radiation therapy or oncolytic viruses resulted in systemic immune responses in a number of oncological patients. The elimination of untreated cancer tissues that may follow a localized therapeutic intervention was termed abscopal effect, which represents a major achievement in the field of cancer therapy.
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Neoplasias/terapia , Terapia Viral Oncolítica , Antígeno B7-H1/antagonistas & inibidores , Antígeno CTLA-4/antagonistas & inibidores , Terapia Combinada , Humanos , Imunoterapia , Neoplasias/radioterapia , Vírus Oncolíticos , Receptor de Morte Celular Programada 1/antagonistas & inibidoresRESUMO
The treatment of incisional hernias, especially those that are multiple or recurring, has always represented important challenges for surgeons. An incisional hernia is a mechanical damage of the abdominal wall that can result in respiratory problems and alterations of splanchnic circulation, especially when in large size hernias. The increasing availability of prostheses with greater resistance Romato infections and tension, lightness, biocompatibility, and reduced visceral adhesions has improved outcomes and minimized relapses. It is still important, however, to carefully choose the type of prosthesis and surgical technique, whether laparotomic or laparoscopic, correlated to the positioning site of the prosthesis. In this observational study we report the results and outcomes of 50 patients surgically treated for incisional hernia in our hospital. The surgical technique used to repair the hernias was laparoscopic with the use of the Ventralight Echo PS. This prosthesis is equipped with a comfortable and innovative pneumatic system that facilitates its positioning during surgery. In our experience, it has brought undeniable advantages for the treatment of incisional hernias and for all patients with parietal defects who could benefit from laparoscopic treatment.