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INTRODUCTION: Odontogenic cervicofacial infections are still an ongoing problem, requiring immediate hospital admittance and management. The aim of this study is to reflect the number of patients with cervicofacial infections who were admitted during the coronavirus disease 2019 (COVID-19) pandemic period in a single, point of reference center in Northern Greece as well as analyze the quantitative and qualitative parameters of patient characteristics and management data. METHODS: This was a retrospective cohort study that included all the patients with cervicofacial infections who were admitted to our unit during the COVID-19 pandemic, specifically between 2020 and 2021. For comparative reasons, patients admitted with cervicofacial infections between 2019 and 2020 (pre-COVID period) were analyzed. RESULTS: In total, 341 patients fulfilled the criteria for this study. Specifically, the number of admitted patients was 151 in the pre-COVID era instead of 190 patients in the pandemic. The mean age of the patients was 45.3 years, with a slight male predominance (54.7% males to 45.3%). The mean duration of hospitalization was 2.5 days in the pre-COVID period instead of 3.42 days in the pandemic. Interestingly, in the pandemic, eight times more patients were admitted to the ICU post-operatively, in contrast to the pre-COVID period (23 vs 3 patients). Also in the COVID period, almost 54.9% of the patients presented with fever and 49.6% with trismus. Moreover, the submandibular space involvement was the most common space of infection in both COVID and pre-COVID groups with (58.9% and 49.7%) respectively. In one-third of all cases, a post-extraction infection of a third molar was the main cause of abscess. CONCLUSION: Cervicofacial infections during the COVID-19 pandemic appeared with more severe symptoms and resulted in an increased number of patients who needed admittance to the intensive care unit, in contrast to the pre-COVID era. Also, the mean length of stay was increased for a day at the same period. This study could be used as an example for further research, in case of similar pandemic situations in the future.
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OBJECTIVES: The aim of this review is to focus on the possibility of patients with squamous cell carcinoma to develop a second primary disease such as DLBCL, perhaps because of the irradiation of the head and neck area. MATERIALS AND METHODS: A case of an 89-year-old man is reported, who initially underwent surgical and complementary treatment for neck squamous cell carcinoma of occult primary and later for tonsillar diffuse large B-cell non-Hodgkin lymphoma. RESULTS: The second primary was considered a recurrence in the neck of the original cancer of unknown primary, so a new surgical management was decided. The final pathology report described a diffuse large B-cell non-Hodgkin lymphoma. CONCLUSIONS: The importance of maintaining follow-ups for patients with occult primary cancers who are at an elevated risk of developing a metastasis or a second primary carcinoma outbreak is highlighted.
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A crucial complication after allogeneic hematopoietic cell transplantation (alloHCT), namely, acute graft-versus-host disease (aGVHD), occurs in about 50% of transplant recipients, leading to high morbidity and mortality. Thus far, the diagnosis of GVHD has been mainly established through clinical features and histologic or laboratory evidence of periductal lymphocyte infiltration, fibroplasia, and mixed lymphocytic and plasmocytic inflammation. Intensive research is focused on identifying biomarkers for the early diagnosis, prediction of disease, response to treatment, prognosis, and risk stratification of patients. The serum biomolecules that have been investigated are reported and summarized. Moreover, oral tissue involvement in GVHD is described, and other biomarkers that have been proposed, such as saliva, are analyzed. Future research is highlighted as a necessity in order for these biomarkers to be validated and quantified for use in clinical practice.
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INTRODUCTION: The aim of this study was to detect the possible endothelial expression of embryonic-type cancer stem cells (CSC) marker SOX2 and the stemness-type CSC marker CD147 in oral potential malignant disorders (OPMDs), oral leukoplakia (OL) in particular, and oral squamous cell carcinoma (OSCC). METHODS: This study focuses on the immunohistochemical pattern of expression of CSC protein-biomarkers SOX2 and CD147 in paraffin-embedded samples of 21 OSCCs of different grades of differentiation and 30 cases of OLs with different grades of dysplasia, compared to normal oral mucosa. RESULTS: The protein biomarker SOX2 was expressed in the endothelial cells, but without establishing any statistically significant correlation among OSCC, OL, and normal tissue specimens. However, SOX endothelial staining was noticed in 7/30 (23.3%) cases of OL (one non-dysplastic, one mildly dysplastic, one moderately dysplastic, and four severely dysplastic cases) and 5/21 (23.8%) cases of OSCC (two well-differentiated, one moderately differentiated, and two poorly differentiated cases). Although CD147 is expressed in normal oral epithelium, OL, and OSCC neoplastic cells, its vascular-endothelial expression was noticed in only 2/5 (40%) cases of normal oral epithelium, 1/30 (3.3%) cases of OL (one severely dysplastic case), and 4/21 (19%) cases of OSCC (two well-differentiated, one moderately differentiated, and one poorly differentiated case). Therefore, no statistically significant correlation among OSCC, OL, and normal tissue specimens was established. CONCLUSION: The endothelial presence of SOX2 both in oral potentially malignant and malignant lesions suggests that SOX2 may be implicated in the microvascularization process and associated with the degree of dysplasia in OL. The expression of CD147 may be attributed both to local inflammation and tumorigenesis. The implementation of CD147 in larger groups of tissue samples will shed some light on its role in cancer and inflammation. The evidence so far supports the need for more studies, which may support the clinical significance of these novel cancer stem cell biomarkers.
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INTRODUCTION: The aim of this study is to evaluate changes in corneal astigmatism, axial anterior corneal curvature, as well as changes in the anterior chamber depth and central corneal thickness, 2 months following the unilateral recession of medial rectus muscle in children. METHODS: Thirty-three children with esotropia were prospectively evaluated following unilateral medial rectus muscle recession, using Pentacam®. Comparisons were made between the operated and fellow unoperated eyes, pre, and postoperatively. The assessment was made for changes in the radius of axial curvature on major meridians at 3 and 3.5 mm from the optical corneal center in the mid-peripheral zone. Astigmatism changes of the anterior and posterior corneal surface were calculated using vector analysis software (astigMATIC®). ANOVA model was used to examine the interaction between age or central corneal thickness and postoperative changes in anterior and posterior surface corneal astigmatism. RESULTS: In the intervention group, changes in anterior and posterior corneal surface astigmatism were statistically significant, with a mean increase of 0.59Dx92 and 0.08Dx91, respectively. In the mid-peripheral corneal zone, there is an increase in the radius of anterior corneal axial curvature more evident nasally 3.5 mm from the corneal center on the horizontal meridian, with corresponding decrease superiorly and inferiorly at 3 and 3.5 mm from the corneal center on the vertical meridian. DISCUSSION: The changes in total astigmatism of the operated eyes are mainly attributed to the anterior corneal surface. These changes are associated with flattening in the 180 meridian of the cornea, leading to a shift to "with-the-rule" astigmatism.
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Astigmatismo , Córnea , Músculos Oculomotores , Humanos , Estudos Prospectivos , Masculino , Feminino , Córnea/patologia , Córnea/diagnóstico por imagem , Criança , Músculos Oculomotores/cirurgia , Músculos Oculomotores/fisiopatologia , Músculos Oculomotores/diagnóstico por imagem , Pré-Escolar , Astigmatismo/fisiopatologia , Astigmatismo/cirurgia , Procedimentos Cirúrgicos Oftalmológicos/métodos , Esotropia/fisiopatologia , Esotropia/cirurgia , Topografia da Córnea , Adolescente , Acuidade Visual/fisiologiaRESUMO
Oral squamous cell carcinoma (OSCC) is the most prevalent type of head and neck cancer, and lymph node metastasis is a crucial prognostic factor that has a direct correlation with the survival rate. The standard procedure for managing clinically negative (cN0) neck in OSCC patients is elective neck dissection (END), but it can lead to various complications that affect the patient's quality of life. Therefore, medical professionals are exploring the use of the sentinel lymph node biopsy (SLNB) to manage cN0 neck in OSCC patients. The aim of this systematic review and meta-analysis was to compare the overall survival (OS) and disease-free survival (DFS) of patients undergoing SLNB and END in the surgical management of early cN0 neck in OSCC patients. To conduct this study, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement was used to report the systematic reviews. The study included all comparative clinical studies, including randomized clinical trials (RCTs), clinical perspective studies, and retrospective studies that compared END to SLNB for early cN0 neck in OSCC patients. The hazard ratio (HR) and risk ratio (RR) with 95% confidence interval (CI) were calculated using comprehensive meta-analysis. The primary outcome variables were OS, DFS, and disease-specific survival (DSS). The secondary outcome variable was the nodal recurrence rate without local or distant metastasis. The GRADE system was used to assess the evidence's certainty. The meta-analysis included 12 clinical studies, comprising three RCTs and seven non-RCTs. The results showed no statistically significant difference between END and SLNB concerning OS (HR = 0.993, CI: 0.814 to 1.211, P = 0.947, low-quality evidence), DFS (HR = 0.705, CI: 0.408 to 1.29, P = 0.21, low-quality evidence), and nodal recurrence (RR = 1.028, CI: 0.969 to 1.090, P = 0.907, low-quality evidence). Additionally, SLNB was non-inferior to END regarding DSS (RR = 1.028, CI: 0.969 to 1.090, P = 0.907, low-quality evidence). In conclusion, this research affirms the safety and precision of SLNB as a means to stage cN0 OSCC patients, with outcomes that are comparable to END in terms of survival and nodal recurrence. Nevertheless, it's crucial to acknowledge that the quality of evidence in this study was relatively low. Therefore, additional RCTs comparing END to SLNB are warranted to validate these results and offer more robust guidance for managing cN0 OSCC patients.
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Carcinoma de Células Escamosas , Procedimentos Cirúrgicos Eletivos , Neoplasias Bucais , Esvaziamento Cervical , Biópsia de Linfonodo Sentinela , Humanos , Neoplasias Bucais/cirurgia , Neoplasias Bucais/patologia , Esvaziamento Cervical/métodos , Carcinoma de Células Escamosas/cirurgia , Carcinoma de Células Escamosas/patologia , Metástase Linfática/patologia , Intervalo Livre de DoençaRESUMO
The purpose of this article is to report a case of bilateral foveal hypoplasia in an eight-year-old girl who presented to the ophthalmology department due to poor vision in both eyes. Clinical examination revealed bilateral nystagmus, decreased vision, as well as iris transillumination. Dilated fundus examination indicated the absence of light reflex around the foveal area and optical coherence tomography (OCT) imaging exhibited the absence of the fovea centralis depression. These findings, in addition to the patient's light-colored hair and skin complexion, raised suspicion for albinism. The patient was referred for genetic testing and the results confirmed the diagnosis of tyrosinase-positive oculocutaneous albinism (OCA2).
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INTRODUCTION: Cancer stem cells (CSCs) are incriminated for initiating the process of carcinogenesis either de novo or through the transformation of oral potentially malignant disorders (OPMDs) to oral squamous cell carcinoma (OSCC). The aim of this study was to detect the expression of embryonic-type CSC markers OCT3/4 and SOX2 in OSCCs and oral leukoplakias (OLs), the most common of OPMDs. MATERIALS AND METHODS: The study type is experimental, and the study design is characterized as semiquantitative research, which belongs to the branch of experimental research. The experiment was conducted in the Department of Oral Medicine/Pathology, School of Dentistry, Aristotle University of Thessaloniki, Greece. This study focuses on the semiquantitative immunohistochemical (IHC) pattern of expression of CSCs protein-biomarkers SOX2 and OCT3/4, in paraffin embedded samples of 21 OSCCs of different grades of differentiation and 30 cases of OLs with different grades of dysplasia, compared to five cases of normal oral mucosa in both terms of cells' stain positivity and intensity. Statistical analysis was performed through SPSS 2017 Pearson Chi-square and the significance level was set at 0.05 (p=0.05). The expression of the respective genes of SOX2 and OCT3/4 was studied through quantitative polymerase chain reaction (qPCR), in paraffin-embedded samples of 12 cases of OLs with mild/non dysplasia and 19 cases moderately/poorly differentiated OSCCs(n=19) and five normal mucosa using the Independent Paired T-test. RESULTS: The genes SOX2 and Oct3/4 were expressed in all examined cases although no statistically significant correlations among normal, OL and OSCC, were established. A nuclear/membrane staining of OCT3/4 was noticed only in three out of 21 OSCCs but in none of OLs or normal cases (without statistical significance). A characteristic nuclear staining of SOX2 was noticed in the majority of the samples, mostly in the basal and parabasal layers of the epithelium. SOX2 was significantly detected in the OSCCs group (strong positivity in 17/21) than in the OL group (30 cases, mostly mildly stained) (p-value=0.007), and the normal oral epithelium (mild stained, p=0.065). Furthermore, SOX2 was overexpressed in well differentiated OSCCs group (5/OSCCs, strongly stained) rather than in mildly dysplastic and non-dysplastic OLs samples (14/OLs, mildly stained) (p-value =0.035). CONCLUSION: The characteristic expression of SOX2 but not of OCT3/4 in OLs' and OSCCs' lesions suggests the presence of neoplastic cells with certain CSC characteristics whose implication in the early stages of oral tumorigenesis could be further evaluated. The clinical use of SOX2, as prognostic factor, requires further experimental evaluation in larger number of samples.
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Total knee arthroplasty (TKA) is currently one of the most common orthopedic surgeries due to the ever-increasing average life expectancy. The constant need for effective and accurate techniques was contributed to the development of three-dimensional (3D) printing in that field, especially for patient-specific instrumentation (PSI) and custom-made implants fabrication. PSI may offer numerous benefits, such as resection accuracy, mechanical axis alignment, cost-effectiveness, and time economy. Nonetheless, the results of existing studies are controversial. For this purpose, a review article of the published articles was conducted to summarize the role of 3D-printed PSI in TKA.
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Aim The aim of the study was to evaluate the long-term effect of large horizontal rectus muscle recession on macula thickness using spectral domain optical coherence tomography (SD-OCT). Material and methods Forty-two children were included in the study. The intervention groups were the medial rectus (MR) group (=20 eyes ) and the lateral rectus (LR) group (=22 eyes), including the eyes that underwent large medial and lateral rectus muscle recession, respectively. The control group included the fellow 42 unoperated eyes of the same children. Each eye was scanned using Topcon Maestro2 OCT-Angiography (OCTA; Topcon, Tokyo, Japan) preoperatively and then two months following surgery. A paired t-test was used to compare the mean difference in macular thickness between the intervention and control groups using the statistical program R (R Foundation for Statistical Computing, Vienna, Austria). Results The mean change in central, parafoveal, and perifoveal macular thickness of the intervention group was not statistically significant. Conclusion The long-term changes in macular thickness, as evaluated using SD-OCT both for the central and peripheral regions of the fovea, following large horizontal rectus muscle recession surgery, are not statistically significant.
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INTRODUCTION: The vascular endothelial (VE) expression of aldehyde dehydrogenase (ALDH) 1/2 family in oral leukoplakia (OL) and oral squamous cell carcinoma (OSCC) cases has not been studied so far. The aim of this study was to illustrate the "off-label" endothelial expression of cancer stem cell (CSC) biomarker, ALDH1/2, adjacent to oral potentially malignant and malignant lesions in order to shed some light on the mechanisms leading to oral carcinogenesis. Materials and methods: The expression of CSC protein-biomarker ALDH1/2 was detected through immunohistochemistry (IHC) in 30 paraffin-embedded samples of OL and 21 samples of OSCC compared to five samples of normal oral mucosa. Statistical analysis was done using SPSS, Pearson Chi-square, and Fischer's exact test. The significance level was set at 0.05 (p≤ 0.05). Results: In oral mucosal vessels, ALDH1/2 was not expressed. It was expressed significantly more in the vessels of OSCCs compared to the OLs (Fisher's exact test, p-value= 0,001). However, when endothelial expression of ALDH1/2 in the vasculature of OLs was compared with that of the normal oral mucosa, no significant change was noticed (Fisher's exact test, p-value=1.000). Discussion: The IHC VE expression of ALDH1/2 in OSCC vasculature but not in OL indicates a possible significantly stronger activation of endothelial cells during carcinogenesis, which could be an indicator of the role of inflammation in the development of field cancerization and of prognostic value for (vascular/lymphatic) metastasis.
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Silica-based ceramics doped with calcium and magnesium have been proposed as suitable materials for scaffold fabrication. Akermanite (Ca2MgSi2O7) has attracted interest for bone regeneration due to its controllable biodegradation rate, improved mechanical properties, and high apatite-forming ability. Despite the profound advantages, ceramic scaffolds provide weak fracture resistance. The use of synthetic biopolymers such as poly(lactic-co-glycolic acid) (PLGA) as coating materials improves the mechanical performance of ceramic scaffolds and tailors their degradation rate. Moxifloxacin (MOX) is an antibiotic with antimicrobial activity against numerous aerobic and anaerobic bacteria. In this study, silica-based nanoparticles (NPs) enriched with calcium and magnesium, as well as copper and strontium ions that induce angiogenesis and osteogenesis, respectively, were incorporated into the PLGA coating. The aim was to produce composite akermanite/PLGA/NPs/MOX-loaded scaffolds through the foam replica technique combined with the sol-gel method to improve the overall effectiveness towards bone regeneration. The structural and physicochemical characterizations were evaluated. Their mechanical properties, apatite forming ability, degradation, pharmacokinetics, and hemocompatibility were also investigated. The addition of NPs improved the compressive strength, hemocompatibility, and in vitro degradation of the composite scaffolds, resulting in them keeping a 3D porous structure and a more prolonged release profile of MOX that makes them promising for bone regeneration applications.
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Genetically modified maize GA21 × T25 was developed by crossing to combine two single events: GA21 and T25. The GMO Panel previously assessed the two single maize events and did not identify safety concerns. No new data on the single maize events were identified that could lead to modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in maize GA21 × T25 does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that maize GA21 × T25, as described in this application, is as safe as its conventional counterpart and the non-GM reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of accidental release of viable maize GA21 × T25 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize GA21 × T25. Post-market monitoring of food and feed is not considered necessary. The GMO Panel concludes that maize GA21 × T25 is as safe as its conventional counterpart and the non-GM reference varieties tested, with respect to potential effects on human and animal health and the environment.
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Genetically modified maize MON 87419 was developed to confer tolerance to dicamba- and glufosinate-based herbicides. These properties were achieved by introducing the dmo and pat expression cassettes. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MON 87419 and its conventional counterpart needed further assessment, except for the levels of arginine and protein in grains which did not raise safety and nutritional concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the dicamba mono-oxygenase (DMO) and phosphinothricin N-acetyltransferase (PAT) proteins as expressed in maize MON 87419. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize MON 87419. In the context of this application, the consumption of food and feed from maize MON 87419 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 87419 is as safe as the conventional counterpart and non-GM maize varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87419 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87419. The GMO Panel concludes that maize MON 87419 is as safe as its conventional counterpart and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.
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Transient osteoporosis (TO) or bone marrow edema syndrome (BMES) is a self-limited clinical condition, which affects middle-aged men and women. It can be treated with miscellaneous conservative and surgical measures, which are analyzed in this systematic review. INTRODUCTION: BMES/TO is a transient clinical entity, which can be treated with various therapeutic modalities. The aim of our study was to assess the efficacy of different therapeutic options for the alleviation of pain and reduction of bone marrow edema (BME) in patients with BMES/TO, as well as to propose a therapeutic algorithm. METHODS: PubMed, Scopus, Cochrane, and Google Scholar were searched. Eligibility and extraction of studies were conducted by two authors. Methodological quality assessment was carried out with the modified Delphi technique, Methodological Index for Non-Randomized Studies (MINORS) criteria, and Cochrane Collaboration's risk of bias tool. Outcomes that were compared were time of pain resolution, VAS pain scores, and BME regression on magnetic resonance imaging (MRI). RESULTS: A total of 36 articles (880 patients) were included. Bisphosphonates had higher efficiency in less than 1-month outcomes on pain resolution compared with core decompression (CD), while iloprost was more efficient at 1-3 months compared with bisphosphonates and CD. At 3-6 months, all three of the aforementioned showed equal results on pain resolution, and at a period of 6-12 months, CD and extracorporeal shockwave therapy (ESWT) showed excellent results followed by bisphosphonates and the conservative group (CG) consisting of non-steroidal anti-inflammatory drugs (NSAIDs) and/or analgesics and/or restricted weight bearing. On MRI at 1-3 months, bisphosphonates, iloprost, and CD had relatively the same outcomes on BME resolution, with the least promising being the CG. At 3-6 months, CD seemed to have achieved the best results on the resolution of BME, followed by ESWT, CG, and bisphosphonates group. At 6-12 months, ESWT had the best outcomes compared with the conservative, bisphosphonates, and iloprost groups. CONCLUSION: BMES/TO has been treated with many non-standardized measures due to the low number of highly reliable studies. Current literature shows promising results with regard to the reduction of the clinical course of BMES/TO, but further large multicenter randomized controlled trials, as well as standardized radiological and clinical scores, are warranted to acquire evidence-based recommendations on the therapeutic algorithm.
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Doenças da Medula Óssea , Osteoporose , Masculino , Pessoa de Meia-Idade , Humanos , Feminino , Iloprosta/uso terapêutico , Medula Óssea , Doenças da Medula Óssea/terapia , Dor/tratamento farmacológico , Difosfonatos/uso terapêutico , Edema/terapia , Edema/tratamento farmacológico , Síndrome , Osteoporose/complicações , Osteoporose/tratamento farmacológico , Estudos Multicêntricos como AssuntoRESUMO
The purpose of this report is to present a case of orbital rhabdomyosarcoma (RMS) masquerading as a dermoid cyst. A six-year-old boy with an unremarkable medical history presented in the outpatient department with a palpable mass in the superonasal region of the right orbit, which had rapidly grown in the past month. The most likely diagnosis was dermoid cyst and the patient was scheduled for surgical excision. A high index of suspicion was raised intraoperatively based on the appearance of the lesion due to the presence of a feeder vessel. The histopathology examination identified alveolar RMS. The patient was referred to a pediatric oncology department and commenced intravenous chemotherapy. RMS may masquerade as various conditions, including dermoid cysts and chalazion. A high index of suspicion should be raised in cases with rapidly growing lesions.
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The aim of this article is to report two cases of Straatsma syndrome, a rare disease characterized by the traditional triad of unilateral myelinated retinal nerve fibres, axial myopia, and amblyopia. The cases were a five-year-old and a three-year-old girl, both with unilateral myopia, visual acuity of 0.1 (decimal), and myelinated retinal nerve fibres in fundoscopy. Prescription of cycloplegic refraction findings and occlusion of the involved eye was attempted in both cases, but visual acuity did not improve. Poor-prognostic factors of Straatsma syndrome include a high degree of anisometropia and extensive myelination.
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Maize MON 87429 was developed to confer tolerance to dicamba, glufosinate, quizalofop and 2,4-D herbicides. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and compositional characteristics tested between maize MON 87429 and its conventional counterpart needs further assessment, except for the levels of phytic acid in grains, which do not raise nutritional and safety concerns. The GMO Panel does not identify safety concerns regarding the toxicity and allergenicity of the DMO, PAT, FT_T and CP4 EPSPS proteins as expressed in maize MON 87429. The GMO Panel finds no evidence that the genetic modification impacts the overall safety of maize MON 87429. In the context of this application, the consumption of food and feed from maize MON 87429 does not represent a nutritional concern in humans and animals. The GMO Panel concludes that maize MON 87429 is as safe as the conventional counterpart and non-GM maize reference varieties tested, and no post-market monitoring of food/feed is considered necessary. In the case of accidental release of viable maize MON 87429 grains into the environment, this would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87429. The GMO Panel concludes that maize MON 87429, as described in this application, is as safe as its conventional counterpart and the tested non-GM maize reference varieties with respect to potential effects on human and animal health and the environment.
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Genetically modified maize MON 89034 × 1507 × MIR162 × NK603 × DAS-40278-9 was developed by crossing to combine five single events: MON 89034, 1507, MIR162, NK603 and DAS-40278-9. The GMO Panel previously assessed the five single maize events and 16 of the subcombinations and did not identify safety concerns. No new data on the single maize events or the assessed subcombinations were identified that could lead to the modification of the original conclusions on their safety. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single maize events and of the newly expressed proteins in the five-event stack maize does not give rise to food and feed safety and nutritional concerns. The GMO Panel concludes that five-event stack maize, as described in this application, is as safe as the non-GM comparator and non-GM maize varieties tested. In the case of accidental release of viable five-event stack maize grains into the environment, this would not raise environmental safety concerns. The GMO Panel assessed the likelihood of interactions among the single events in nine of the maize subcombinations not previously assessed and concludes that these are expected to be as safe as the single events, the previously assessed subcombinations and the five-event stack maize. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 89034 × 1507 × MIR162 × NK603 × DAS-40278-9. Post-market monitoring of food/feed is not considered necessary. The GMO Panel concludes that the five-event stack maize and its subcombinations are as safe as its non-GM comparator and the tested non-GM maize varieties with respect to potential effects on human and animal health and the environment.