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This paper outlines an experimental demonstration of a Bayesian image reconstruction approach to achieve rapid single-photon color imaging of moving objects. The capacity to extract the color of objects is important in a variety of target identification and computer vision applications. Nonetheless, it remains challenging to achieve high-speed color imaging of moving objects in low-photon flux environments. The low-photon regime presents particular challenges for efficient spectral separation and identification, while unsupervised image reconstruction algorithms are often slow and computationally expensive. In this paper, we address both of these difficulties using a combination of hardware and computational solutions. We demonstrate color imaging using a Single-Photon Avalanche Diode (SPAD) detector array for rapid, low-light-level data acquisition, with an integrated color filter array (CFA) for efficient spectral unmixing. High-speed image reconstruction is achieved using a bespoke Bayesian algorithm to produce high-fidelity color videos. The analysis is conducted first on simulated data allowing different pixel formats and photon flux scenarios to be investigated. Experiments are then performed using a plasmonic metasurface-based CFA, integrated with a 64 × 64 pixel format SPAD array. Passive imaging is conducted using white-light illumination of multi-colored, moving targets. Intensity information is recorded in a series of 2D photon-counting SPAD frames, from which accurate color information is extracted using the fast Bayesian method introduced herein. The per-frame reconstruction rate proves to be hundreds of times faster than the previous computational method. Furthermore, this approach yields additional information in the form of uncertainty measures, which can be used to assist with imaging system optimization and decision-making in real-world applications. The techniques demonstrated point the way towards rapid video-rate single-photon color imaging. The developed Bayesian algorithm, along with more advanced SPAD technology and utilization of time-correlated single-photon counting (TCSPC) will permit live 3D, color videography in extremely low-photon flux environments.
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OBJECTIVE: We explored the efficacy and safety profile of cenobamate as an adjunctive therapy in patients with refractory focal-onset epilepsy in the pediatric population. METHODS: This was a retrospective, single-center study of cenobamate used as an adjunctive medication in pediatric patients with refractory focal-onset epilepsy . We measured seizure reduction, median reduction in seizure frequency, median dose, responder rate, and treatment-emergent adverse events. RESULTS: We studied the efficacy and safety profile of cenobamate in 21 pediatric patients (mean age 15.9). Cenobamate was up titrated using the prescribed starter pack with final doses ranging from 100â¯mg to 400â¯mg daily. The mean and median dose of cenobamate was 209.8â¯mg (±98.87â¯mg) and 200â¯mg (175-275), respectively. For patients weighing less than 50â¯kg, mean and median dose was 4.0â¯mg/kg/day (3.20-4.63) and 4.32â¯mg/kg/day, respectively. Mean and median baseline seizure frequency per month in this cohort was 15.38 and 16, respectively, prior to the introduction of cenobamate. After the adjunctive use of cenobamate, mean and median seizure frequency per month reduced to 7.29 and 1, respectively; median reduction in seizure frequency was 93.7%. Seizure reduction of at least 50% (responder rate) was noted in 13 (62.5%) patients and a seizure reduction of at least 75% noted in 11 (52.4%) patients, similar to that seen in adults. Four patients (19%) achieved seizure freedom. Of the 21 pediatric patients, 9 (42.8%) patients had treatment-emergent adverse events (TEAE) with the most commonly reported symptom being ataxia (5, 23.8%) and sedation (2, 9.5%). Three (14.3%) patients discontinued early due to these side effects. No children developed drug rash with eosinophilia and systemic symptoms (DRESS). CONCLUSION: Cenobamate demonstrates similar efficacy rates and safety profile within the pediatric population when compared to the published adult data, making it an effective, safe, and tolerable adjunctive medication for children with refractory focal-onset epilepsy, even at the maximum daily dose.
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Epilepsia Resistente a Medicamentos , Epilepsias Parciais , Epilepsia , Adolescente , Adulto , Anticonvulsivantes/uso terapêutico , Carbamatos , Criança , Clorofenóis , Epilepsia Resistente a Medicamentos/induzido quimicamente , Epilepsia Resistente a Medicamentos/tratamento farmacológico , Epilepsias Parciais/tratamento farmacológico , Epilepsia/tratamento farmacológico , Humanos , Estudos Retrospectivos , Convulsões/induzido quimicamente , Convulsões/tratamento farmacológico , Tetrazóis , Resultado do TratamentoRESUMO
We experimentally demonstrate a CMOS compatible medium wave infrared metal-insulator-metal (MIM) metamaterial absorber structure where for a single dielectric spacer thickness at least 93% absorption is attained for 10 separate bands centred at 3.08, 3.30, 3.53, 3.78, 4.14, 4.40, 4.72, 4.94, 5.33, 5.60 µm. Previous hyperspectral MIM metamaterial absorber designs required that the thickness of the dielectric spacer layer be adjusted in order to attain selective unity absorption across the band of interest thereby increasing complexity and cost. We show that the absorption characteristics of the hyperspectral metamaterial structures are polarization insensitive and invariant for oblique incident angles up to 25° making them suitable for practical implementation in an imaging system. Finally, we also reveal that under TM illumination and at certain oblique incident angles there is an extremely narrowband Fano resonance (Q > 50) between the MIM absorber mode and the surface plasmon polariton mode that could have applications in hazardous/toxic gas identification and biosensing.
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INTRODUCTION: Felbamate was approved in 1993 to treat partial seizures with and without secondary generalization in adults and in Lennox-Gastaut Syndrome in children. Its use was later restricted when rare but fatal cases of aplastic anemia and hepatic failure were identified. METHODS: This single center analysis retrospectively evaluated the safety and efficacy of felbamate in a cohort of children, adolescents, and adults with epilepsy. RESULTS: A chart review identified 103 patients taking felbamate. The range of felbamate dose was 300-4500 mg (mean: 1800 ± 900 mg). The duration of therapy ranged from 1 month to 20 years (mean duration: 35 ± 45 months). Eighteen (17.5%) subjects experienced adverse events including insomnia, nausea, vomiting, decreased appetite, weight loss, gastric discomfort, diarrhea, mood and behavioral problems, high blood pressure, headache, and elevated liver enzymes. Out of these, 6 (5.9%) patients discontinued the therapy. No hepatic failure or agranulocytosis was observed. Fifty-nine (57.72%) patients achieved ≥ 50% reduction in seizure frequency, and 30 (29.12%) patients achieved seizure freedom. CONCLUSIONS: These findings suggest that felbamate is safe, well tolerated, and effective in treatment of various types of epilepsy syndromes.
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Anticonvulsivantes/efeitos adversos , Anticonvulsivantes/uso terapêutico , Epilepsia/tratamento farmacológico , Fenilcarbamatos/efeitos adversos , Fenilcarbamatos/uso terapêutico , Propilenoglicóis/efeitos adversos , Propilenoglicóis/uso terapêutico , Convulsões/tratamento farmacológico , Adolescente , Adulto , Idade de Início , Anemia Aplástica/induzido quimicamente , Criança , Estudos de Coortes , Rotulagem de Medicamentos , Felbamato , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Adulto JovemRESUMO
INTRODUCTION: Perampanel is an AMPA receptor antagonist recently approved for the treatment of partial and generalized epilepsies with tonic-clonic seizures as an add-on therapy. METHODS: This single-center postmarketing study retrospectively evaluated the efficacy of perampanel in patients with partial onset and other seizure types, with a special emphasis on its efficacy, safety, and tolerability. RESULTS: Review of medical records revealed that adequate data were available on 101 patients taking perampanel. Fifty-seven patients were female. Sixteen patients were of pediatric age range. The average dose of perampanel was 6.5mg, and average treatment duration was 8.2months. After treatment, median seizure frequency reduction was 50% overall, 50% in children, and 33% in adults; 44% in primary generalized, 38% in secondarily generalized, and 33% in partial seizures. Responder rate (50% seizure frequency reduction) was 51% overall, 63% in children, and 49% in adults; 60% in partial seizures, 43% in secondarily generalized tonic-clonic seizures, 53% in primary generalized tonic-clonic seizures, and 56% in other seizure types. Seizure freedom was attained in 6% of cases. Most common adverse events were sleepiness/fatigue (35%), behavioral problems (30%), and dizziness (22%). Adverse events were correlated with dosage. Average dose was 7.3mg in patients with adverse events vs. 5.5mg in those without adverse events. Patients who developed fatigue, cognitive decline, headaches, and weight gain were more likely to discontinue perampanel than those patients who experienced coordination issues and behavioral problems. CONCLUSIONS: These findings suggest that perampanel is safe, well-tolerated, and effective in treatment of various types of adult and pediatric epilepsy syndromes. Fatigue, cognitive decline, headache and weight gain were the main causes of perampanel discontinuation.
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Anticonvulsivantes/efeitos adversos , Anticonvulsivantes/uso terapêutico , Epilepsia Tônico-Clônica/tratamento farmacológico , Piridonas/efeitos adversos , Piridonas/uso terapêutico , Receptores de AMPA/antagonistas & inibidores , Adolescente , Adulto , Idoso , Criança , Pré-Escolar , Relação Dose-Resposta a Droga , Epilepsias Parciais/tratamento farmacológico , Fadiga/induzido quimicamente , Fadiga/psicologia , Feminino , Humanos , Lactente , Masculino , Pessoa de Meia-Idade , Nitrilas , Vigilância de Produtos Comercializados , Estudos Retrospectivos , Segurança , Convulsões/prevenção & controle , Resultado do Tratamento , Adulto JovemRESUMO
Introduction In modern dentistry, the focus is more on preventing caries than on treating it, which helps preserve the tooth structure. Pit and fissure sealants (PFS) are the most effective methods for providing a mechanical barrier and avoiding the accumulation of dental plaque in deep pits and fissures, thereby preventing occlusal caries. The present study was conducted to compare the efficiency of dentin bonding agents (DBA) with or without fissurotomy in reducing microleakage before PFS placement. Materials and methods A total of 48 freshly extracted premolars were randomly divided into four groups as follows: Group 1, the conventional technique of PFS (Clinpro, 3M ESPE sealant); Group 2, fissurotomy performed before PFS placement; Group 3, Scotchbond Universal Adhesive (3M ESPE DBA) applied before PFS placement; and Group 4, fissurotomy along with DBA was used before PFS placement. The teeth were subjected to thermocycling followed by dye penetration using a 1% solution of methylene blue for 24 hours. All teeth were then assessed for microleakage by a qualitative method using a stereomicroscope at 40X and depth of dye penetration by image analysis. The Kruskal-Wallis test followed by Dunn's test was used for intergroup comparisons of microleakage scores, and ANOVA followed by Tukey's test was used for intergroup comparisons of the depth of dye penetration. These analyses were conducted using statistical software (SPSS version 22, Chicago, IL, USA). Results Statistically significant differences were observed between the groups in terms of the microleakage scores and depth of dye penetration (p<0.05). The group 4 showed a minimum microleakage score (0.50±0.52), and maximum scores were observed in Group 1 (2.16±0.71). Group 2 showed insignificant differences with groups 3 and 4 for depth of dye penetration (p>0.05). Statistically significant differences were observed between groups 1 and 2, groups 1 and 4, and groups 3 and 4 for the microleakage score (p<0.05). Conclusion Fissurotomy with or without DBA significantly reduced microleakage before the PFS placement. Prior use of fourth-generation DBA significantly reduced microleakage compared with PFS placement without the use of DBA.
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INTRODUCTION: Fixed functional appliances are widely used for the treatment of retrognathic mandibles in skeletal class II malocclusion. The primary objective of the present investigation was to evaluate and compare the treatment effects induced by PowerScope (American Orthodontics, Sheboygan, WI) and AdvanSync2 (Ormco, Orange, CA). The hypothesis posited that there were no notable disparities in the therapeutic impacts of the two appliances. MATERIALS AND METHODS: A retrospective study was undertaken involving 90 subjects with retrognathic mandibles. Group 1 was treated with AdvanSync2, group 2 received PowerScope treatment, and group 3 consisted of an untreated class II control sample. Lateral cephalograms were traced at pre-treatment (T0) and post-treatment (T1), to measure various skeletal, dental, and soft tissue parameters. The comparison between the groups was done using analysis of variance (ANOVA) and post-hoc analysis by Tukey's test. RESULTS: Significant changes were observed in all the parameters, comparing the effects of both appliances to the control group (p < 0.05). AdvanSync2 displayed statistically significant skeletal effects on the maxilla and mandible (p < 0.05). The statistically significant differences were also seen for dental effects such as reduction in overbite and overjet. On the other hand, PowerScope exhibited effects that were not considered statistically significant on the maxilla, instead primarily manifesting dento-alveolar changes that led to a considerable reduction in overbite. In comparison to the control group, both appliances notably produced soft tissue changes. CONCLUSIONS: Our study rejected the null hypothesis. AdvanSync2 yielded superior skeletal outcomes with greater mandibular advancement, compared to PowerScope, which exhibited enhanced dento-alveolar alterations. AdvanSync2 took less treatment time, compared to PowerScope.
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Background: Acute neurological complications from COVID-19 have been reported in both pediatric and adult populations. Chronic symptoms after recovery have been reported in adults and can include neuropsychiatric and sleep symptoms. Persistent symptoms in children with the multisystem inflammatory syndrome in children (MIS-C) have not been studied. Methods: We conducted a single-center retrospective chart review and cross-sectional survey of patients diagnosed with MIS-C. Patients and parents were surveyed on symptoms before the COVID-19 pandemic, upon admission, and 23 weeks (interquartile range 20-26 weeks) after discharge. Age and gender-matched patients requiring intensive care unit (ICU) care for status asthmaticus were surveyed as a control group. Results: In this cohort of 47 patients, 77% reported neurological, 60% psychiatric, and 77% sleep symptoms during hospitalization. Prior to hospitalization, 15% reported neurological, 0% psychiatric, and 7% sleep symptoms. Eighteen (50%) of the 36 patients who had neurological symptoms during hospitalization continued to have symptoms on follow-up (odds ratio [OR] = ∞, p = .003]). Similarly, 16 (57%) of 28 patients with psychiatric symptoms reported persistence at follow-up (OR = 5.00; p = .02). Fifteen (42%) of the 18 patients reporting sleep disturbance during hospitalization had persistence on follow-up (OR = 1.9; p = .49). The aggregate of neurological, psychiatric, and sleep symptoms during admission and at follow-up was significantly higher for MIS-C patients requiring ICU care when compared to the control group (p = .01). Conclusions: In this cohort of patients with MIS-C, a majority of patients reported new-onset neuropsychiatric and sleep symptoms. Almost half of these patients had persistent symptoms on a follow-up survey.
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COVID-19 , Adulto , COVID-19/complicações , Criança , Estudos Transversais , Hospitalização , Humanos , Pandemias , Estudos Retrospectivos , Sono , Síndrome de Resposta Inflamatória SistêmicaRESUMO
The polarization state of light is a key parameter in many imaging systems. For example, it can image mechanical stress and other physical properties that are not seen with conventional imaging and can also play a central role in quantum sensing. However, polarization is more difficult to image, and polarimetry typically involves several independent measurements with moving parts in the measurement device. Metasurfaces with interleaved designs have demonstrated sensitivity to either linear or circular/elliptical polarization states. Here, we present an all-dielectric meta-polarimeter for direct measurement of any arbitrary polarization state from a single-unit-cell design. By engineering a completely asymmetric design, we obtained a metasurface that can excite eigenmodes of the nanoresonators, thus displaying a unique diffraction pattern for not only any linear polarization state but all elliptical polarization states (and handedness) as well. The unique diffraction patterns are quantified into Stokes parameters with a resolution of 5° and with a polarization state fidelity of up to 99 ± 1%. This holds promise for applications in polarization imaging and quantum state tomography.
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OBJECTIVE: To describe inpatient length of stay patterns, identify key drivers related to prolonged length of stay, and evaluate the relationship between length of stay and readmission in pediatric neurology. METHODS: This was a retrospective review of patients <19 years old admitted with a principal neurologic diagnosis to our hospital between January 2017 and July 2019. Scheduled admissions and hospital admissions lasting >30 days were excluded from analysis. Length of stay was obtained in addition to demographic characteristics, principal discharge diagnosis, multispecialty care, use of multiple antiseizure medications, inpatient hospital costs (ie, claims paid), and pediatric intensive care unit (ICU) admission for unplanned admissions and 7- and 30-day readmissions. RESULTS: There were a total of 1579 unplanned admissions. The most common reasons for admission were seizure (n = 942), headache (n = 161), other neurologic diagnosis (n = 121), and psychiatric disorders/functional neurologic disorder (n = 60). Children admitted to the hospital for a neurologic condition have an average length of stay of 2.8±5.0 days for unplanned admissions, 4.5±7.4 days for 7-day readmissions, and 5.2±7.5 days for 30-day readmissions. Average inpatient hospital costs were $44 075±56 976 for unplanned admissions, $60 361±71 427 for 7-day readmissions, and $55 434±56 442 for 30-day readmissions. Prolonged length of stay and increased hospital costs were associated with pediatric ICU admission, multispecialty care, 7- and 30-day readmission, multiple antiseizure medications, and psychiatric disorders / functional neurologic disorders. CONCLUSIONS: Pediatric ICU admission, multispecialty care, readmission, multiple antiseizure medications, and psychiatric disorder / functional neurologic disorder prolong length of stay and increase hospital costs.
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Tempo de Internação/estatística & dados numéricos , Doenças do Sistema Nervoso/terapia , Neurologia/métodos , Readmissão do Paciente/estatística & dados numéricos , Pediatria/métodos , Criança , Feminino , Hospitalização , Hospitais , Humanos , Masculino , Estudos RetrospectivosRESUMO
New-onset refractory status epilepticus (NORSE) describes prolonged or recurring new onset seizures which fail to respond to antiseizure medications. NORSE poses a challenge in diagnosis and treatment, and limited high-quality evidence exists to guide management. The efficacy of Electroconvulsive therapy (ECT) in aborting refractory status epilepticus has been described in case reports, but its application remains uncommon, particularly in young children. We describe a case of NORSE in a 3-year old child in which ECT played an important role in aborting status epilepticus, facilitating the diagnosis and surgical excision of an underlying focal cortical dysplasia. Although further research is needed, our case suggests that ECT can be a valuable tool in the treatment of refractory status epilepticus in children.
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Eletroconvulsoterapia , Estado Epiléptico , Criança , Pré-Escolar , Humanos , Recidiva , Estado Epiléptico/terapiaRESUMO
We present the first realisation of simultaneous multi-spectral fluorescence imaging using a single-photon avalanche diode (SPAD) array, where the spectral unmixing is facilitated by a plasmonic metasurface mosaic colour filter array (CFA). A 64 × 64 pixel format silicon SPAD array is used to record widefield fluorescence and brightfield data from four biological samples. A plasmonic metasurface composed of an arrangement of circular and elliptical nanoholes etched into an aluminium thin film deposited on a glass substrate provides the high transmission efficiency CFA, enabling a bespoke spectral unmixing algorithm to reconstruct high fidelity, full colour images from as few as â¼3 photons per pixel. This approach points the way toward real-time, single-photon sensitive multi-spectral fluorescence imaging. Furthermore, this is possible without additional bulky components such as a filter wheel, prism or diffraction grating, nor the need for multiple sample exposures or multiple detectors.
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Algoritmos , Fótons , Cor , Microscopia de Fluorescência , Imagem ÓpticaRESUMO
There is a global unmet need for rapid and cost-effective prognostic and diagnostic tools that can be used at the bedside or in the doctor's office to reduce the impact of serious disease. Many cancers are diagnosed late, leading to costly treatment and reduced life expectancy. With prostate cancer, the absence of a reliable test has inhibited the adoption of screening programs. We report a microelectronic point-of-care metabolite biomarker measurement platform and use it for prostate cancer detection. The platform, using an array of photodetectors configured to operate with targeted, multiplexed, colorimetric assays confined in monolithically integrated passive microfluidic channels, completes a combined assay of 4 metabolites in a drop of human plasma in under 2 min. A preliminary clinical study using l-amino acids, glutamate, choline, and sarcosine was used to train a cross-validated random forest algorithm. The system demonstrated sensitivity to prostate cancer of 94% with a specificity of 70% and an area under the curve of 0.78. The technology can implement many similar assay panels and hence has the potential to revolutionize low-cost, rapid, point-of-care testing.
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STUDY OBJECTIVES: Pediatric insomnia is a widespread problem and especially difficult to manage in children with neurodevelopmental disorders. There are currently no US Food and Drug Administration-approved medications to use once first-line therapy fails. The objective of this study was to evaluate the efficacy and tolerability of doxepin in pediatric patients. METHODS: This is a retrospective single-center chart review of children and adolescents (2-17 years of age) whose sleep failed to improve with behavioral intervention and melatonin who were then trialed on doxepin. Treatment was initiated at a median starting dose of 2 mg and slowly escalated to a median maintenance dose of 10 mg. Improvement in sleep was recorded using a 4-point Likert scale reported by parents on follow-up visits. RESULTS: A total of 29 patients were included in the analysis. Mean follow-up duration was 6.5 ± 3.5 months. Of 29 patients, 4 (13.8%) patients discontinued doxepin because of lack of efficacy or side effects. Eight (27.6%) patients showed significant improvement of their insomnia, 8 (27.6%) showed moderate improvement, 10 (34.5%) showed mild improvement, and 3 (10.3%) showed minimal to no improvement on treatment with doxepin (P < .05) Only 2 patients (6.9%) experienced adverse effects in the form of behavioral side effects (aggression) and enuresis. CONCLUSIONS: Results of our studies suggest that low-dose doxepin is both effective and well tolerated in pediatric patients with insomnia.
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Melatonina , Distúrbios do Início e da Manutenção do Sono , Adolescente , Criança , Doxepina/uso terapêutico , Humanos , Estudos Retrospectivos , Sono , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológicoRESUMO
BACKGROUND: There is limited data available on the safety of therapeutic plasma exchange (TPE) for paediatric neuro-immunological disorders (PNID). In this study, we report our data on safety and feasibility of TPE for these disorders. METHODS: Retrospective chart review was performed to include all patient who received TPE for four major PNID conditions: autoimmune encephalitis (AIE), acute disseminated encephalomyelitis (ADEM), Neuromyelitis optic spectrum disorder (NMOSD) and transverse myelitis (TM). We recorded minor and major adverse effects (AEs) associated with each TPE procedure. Secondary analysis also looked at the efficacy data of TPE on these patients. RESULTS: Thirty-two patients with PNID received a total of 186 TPE cycles. Out of these, only 1 cycle (0.89%) in AIE subgroup, 1 (4.3%) in NMOSD and 1 (4.5%) in TM had adverse effects. No patients had major side effects. CONCLUSION: TPE was safe and well tolerated in our PNID patients.
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Encefalite/terapia , Encefalomielite Aguda Disseminada/terapia , Doença de Hashimoto/terapia , Mielite Transversa/terapia , Neuromielite Óptica/terapia , Troca Plasmática/métodos , Adolescente , Criança , Pré-Escolar , Estudos de Viabilidade , Feminino , Humanos , Lactente , Masculino , Troca Plasmática/efeitos adversos , Estudos Retrospectivos , Adulto JovemRESUMO
BACKGROUND: Early hospital discharge is an important quality improvement (QI) measure that has not been well studied in pediatric neurology. The objective of our study was to implement strategies to improve hospital discharge times for patients admitted to the pediatric neurology service. METHODS: This was a pilot QI study of hospital discharge before noon (DBN) in pediatric neurology patients admitted to a tertiary care children's hospital. The study duration was 6 months (12/2017-05/2018)-first 3 months preintervention and next 3 months postintervention. Strategies focusing on preidentifying MRI candidates and those needing home care services, identifying pharmacy preference, reviewing overnight video EEGs first thing in the morning, and implementing morning huddles, etc., were implemented. Demographic and clinical data were collected, including age, sex, race, and reasons for delay in discharge. Chi-square, t test, and survival analysis (log-rank test) were performed to determine differences between baseline and post-QI implementation. RESULTS: One hundred ninety-one patients were included in the study. There were 76 participants before the implementation of the study and 115 participants during the study. DBN percentage increased in the intervention period, from a baseline of 40.7% to 60.8%. Survival analysis showed that the discharge time after QI implementation improved significantly (p = 0.043). CONCLUSIONS: Our study successfully identified the factors associated with late discharge and developed effective strategies to improve DBN in an inpatient pediatric neurology setting.
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Advances in continuous manufacturing in the pharmaceutical industry necessitate reliable process monitoring systems that are capable of handling measurement errors inherent in all sensor technologies and detecting measurement outliers to ensure operational reliability. The purpose of this work was to demonstrate data reconciliation (DR) and gross error detection methods as real-time process management tools to accomplish robust process monitoring. DR mitigates the effects of random measurement errors, while gross error detection identifies nonrandom sensor malfunctions. DR is an established methodology in other industries (i.e., oil and gas) and was recently investigated for use in drug product continuous manufacturing. This work demonstrates the development and implementation of model-based steady-state data reconciliation on 2 different end-to-end continuous tableting lines: direct compression and dry granulation. These tableting lines involve different equipment and sensor configurations, with sensor network redundancy achieved using equipment-embedded sensors and in-line process analytical technology tools for the critical process parameters and critical quality attributes. The nonlinearity of the process poses additional challenges to solve the steady-state data reconciliation optimization problem in real time. At-line and off-line measurements were used to validate the framework results.
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Composição de Medicamentos/métodos , Comprimidos , Algoritmos , Composição de Medicamentos/instrumentação , Desenho de Equipamento , Controle de Qualidade , Comprimidos/químicaRESUMO
BACKGROUND: Ethnic differences in lipid profiles exist in children and adolescents. This study assessed whether variations in lipid profiles present in overweight and obese youth were also observed in severely obese youth. Variations could explain the lower prevalence of the metabolic syndrome in certain ethnic groups at even severe levels of obesity. METHODS: Data were obtained from the National Health and Nutrition Examination Survey for the years of 2001 through 2012. Subjects were divided into groups according to BMI classification. Normal weight was defined as a BMI less than the 85th percentile. Overweight was defined as a BMI between the 85th and 95th percentile. Class 1 obesity was defined as a BMI greater than the 95th percentile up to 120% of the 95th percentile. A BMI between 120% and 140% of the 95th percentile was defined as Class 2 obesity. Class 3 was defined as a BMI above 140% of the 95th percentile. Primary outcomes were mean total cholesterol, triglyceride, low-density lipoprotein, and high-density lipoprotein levels (HDL). RESULTS: The sample included 14,481 non-Hispanic black (NHB) (N = 4710), non-Hispanic white (N = 4910), and Mexican American (N = 4861) subjects. Across all BMI categories, the NHB group had significantly lower mean TG and higher mean HDL levels (p < 0.0001). CONCLUSIONS: Ethnic variations in lipid profiles were found in severely obese youth. These findings could explain the lower prevalence of the metabolic syndrome in NHB youth. Ethnic-specific guidelines are necessary for improved identification of those at risk at all levels of obesity.