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Purpose: Research and regulatory approval for pediatric uses of prescription drugs often lag years after adult approvals, during which time substantial off-label use of medications in children can occur. We evaluated whether US Food and Drug Administration (FDA) regulatory actions affected the pediatric use of omalizumab, a biologic drug used to treat asthma., Methods: In this serial cross-sectional study, we identified quarterly cohorts of children (0-18 years) with moderate-to-severe asthma within two large national claims databases of those with commercial insurance and Medicaid from 2003 to 2019. Using an interrupted time-series analysis, we fit segmented linear regression models to identify changes in the incidence of omalizumab use in 6-11-year-old children compared with 12-18-year-olds after two time points: (1) 2009Q3 when an FDA advisory committee voted against use for 6-11-year-old children and (2) 2016Q2 when FDA expanded omalizumab's labeling to include 6-11-year-old children., Results: We identified 9298 new pediatric omalizumab users (84% Medicaid). Among 6-11-year-old children, the incidence of omalizumab use did not change following the FDA's initial review of evidence in 2009 and increased after 2016 Q2 FDA approval for this age group in both Medicaid (58 per 100 000 children with asthma, 95% confidence interval [CI] 27-89, p < 0.001) and commercial insurance (57 per 100 000, 95% CI 21-94, p = 0.003) compared with 12-18-year-old children., Conclusions: The use of omalizumab among asthmatic children aged 6-11 years remained steady after FDA advisory committee concerns in 2009 and increased after FDA expanded the indication to include this population in 2016. Additional market incentives may help to ensure the timely generation of evidence and regulatory approval of medications for children., (© 2024 John Wiley & Sons Ltd.)

Efficient charge storage is a key requirement for a range of applications, including energy storage devices and catalysis. Metal-organic frameworks are potential materials for efficient charge storage due to their self-supported three-dimensional design. MOFs are high surface area materials made up of coordination of appropriate amounts of metal ions and organic linkers, hence used in various applications. Yet, creating an effective MOF nanostructure with reduced random crystal formation continues to be a difficult task. The energy efficiency and electrochemical yield of bulk electrodes are improved in this study by demonstrating an effective technique for growing MOFs over a conducting substrate utilizing electrodeposition. An exceptionally stable asymmetric supercapacitor is created when activated carbon cloth is combined with the resulting MOF structure that was directly synthesized via an electrochemical method resulting in 97% stability over 5k cycles which is higher than conventional processes. High performance in supercapacitors is ensured by this practical approach for producing MOF electrodes, making it a suitable structure for effective charge storage., (© 2024. The Author(s).)

We study coupled Gauss maps in one dimension with nearest-neighbor interactions. We observe transitions from spatiotemporal chaos to period-3 states in a coarse-grained sense and synchronized period-3 states. Synchronized fixed points are frequently observed in one dimension. However, synchronized periodic states are rare. The obvious reason is that it is very easy to create defects in one dimension. We characterize all transitions using the following order parameter. Let x∗ be the fixed point of the map. The values above (below) x∗ are classified as +1 (-1) spins. We expect all sites to return to the same band after three time steps for a coarse-grained periodic or three-period state. We define the flip rate F(t) as the fraction of sites i such that si(3t-3)≠si(t). It is zero in the coarse-grained periodic state. This state may or may not be synchronized. We observe three different transitions. (a) If different sites reach different bands, the transition is in the directed-percolation universality class. (b) If all sites reach the same band, we find an Ising-type transition. (c) A synchronized period-3 state where a new exponent is observed. We also study the finite-size scaling at critical points. The exponents obtained indicate that the synchronized period-3 transition is in a new universality class., (© 2024 Author(s). Published under an exclusive license by AIP Publishing.)

With the popularity of 3D-printing technology, poly(lactic acid) (PLA) has become a very good option for layer by layer printing as it is easy to handle, environment friendly, has low costs and most importantly, it is highly adaptable to different materials including carbon, nylon and some other fibres. PLA is an aliphatic poly-ester that is 100% bio-based and is bio-degradable as well. It is one of the rare bio-polymers to compete with traditional polymers in terms of performance and environmental impact. However, PLA is sensitive to water and susceptible to degradation under natural conditions of ultra-violet rays (UV), humidity, fumes, etc. There are many reports on the bio-degradation and photo-degradation of PLA which deal with the accelerated weathering test . However, the accelerated weathering test instruments lack the ability to correlate the stabilities maintained by the test with the actual occurrences during natural exposure. Thus, an attempt has been made in the present work to expose the 3D-printed PLA samples to actual atmospheric conditions of Aurangabad city (M.S.) in India. The degradation of PLA after the exposure is studied and a mechanism is elucidated. Additionally, the tensile properties of the PLA samples are evaluated to correlate the extent of degradation and the material performance. It was found that though the performance of PLA deteriorates with the exposure time, the combination of in-fill pattern and volume plays an important role on the tensile properties and the extent of degradation. It is concluded herein that with natural exposure, the degradation of PLA occurs in two stages, supported by a side reaction. Thus, this study offers a new perspective towards the life of components in actual application by exposing PLA to the natural atmosphere and evaluating its strength and structure., Competing Interests: There are no conflicts to declare., (This journal is © The Royal Society of Chemistry.)

In "Missing the Forest for the Trees: Aduhelm, Accelerated Approvals & the Agency," Dr. Matthew Herder argues that agency capture and politicized discretion drive delays in confirmatory trials of accelerated approval drugs amongst other concerns at US Food and Drug Administration (FDA). In highlighting this important problem and offering nuanced insight into agency workings based in part on interviews with twenty-three unnamed FDA officials and a three-drug case study, Dr. Herder suggests two innovative solutions. However, amidst broader debates balancing agency expertise, data, and delegation, these proposed policy solutions would benefit from more corroborative evidence and consideration of institutional advantages within constitutional limits.

We study the contact process on layered networks in which each layer is unidirectionally coupled to the next layer. Each layer has elements sitting on (i) an Erdös-Réyni network, and (ii) a d-dimensional lattice. The top layer is not connected to any layer and undergoes an absorbing transition in the directed percolation class for the corresponding topology. The critical infection probability p&#95;{c} for the transition is the same for all layers. For an Erdös-Réyni network the order parameter decays as t^{-δ&#95;{l}} at p&#95;{c} for the lth layer with δ&#95;{l}∼2^{1-l}. This can be explained with a hierarchy of differential equations in the mean-field approximation. The dynamic exponent z=0.5 for all layers and ν&#95;{∥}→2 for larger l. For a d-dimensional lattice, we observe a stretched exponential decay of the order parameter for all but the top layer at p&#95;{c}.

Redox active electrolyte supercapacitors differ significantly from the conventional electrolytes based storage devices but face a long term stability issue which requires a different approach while designing the systems. Here, we show the change in layered double hydroxides (LDHs) systems with rare earth elements (lanthanum) can drastically influence the stability of two dimensional LDH systems in redox electrolyte. We find that the choice of rare earth element (lanthanum) having magnetic properties and higher thermal and chemical stability has a profound effect on the stability of La-Co LDHs electrode in redox electrolyte. The fabricated hybrid device with rare earth based positive electrode and carbon as negative electrode having redox electrolyte leads to long stable high volumetric/gravimetric capacity at high discharge rate, demonstrates the importance of considering the rare earth elements while designing the LDH systems for redox active supercapacitor development., (© 2022. The Author(s).)

A sucrose derived carbon quantum dots/polyaniline (S-CQD/PANI) nanocomposite was synthesized as electrode materials by electrodeposition method to achieve excellent electrocapacitive performance for supercapacitor application. The morphology reveals that CQD were distributed uniformly over the surface of PANI. The highest specific capacitance obtained to be 1512.4 Fg -1 at current density 1 Ag -1 for S-CQD/PANI-25 composite in three electrode system with 1 M H₂SO₄ aqueous electrolyte within the potential range of -0.2 to 0.8 V. In addition asymmetric supercapacitor device was fabricated reveals highest specific capacitance of 295 Fg -1 at 1 Ag -1 with excellent stability over 1000 cycle at 3 Ag -1 . Remarkably, the device delivers energy density of 40.86 Whkg -1 at power density 2000 Wkg -1 .

The photoluminescence quenching of graphitic carbon nitride (GCN) was systematically investigated with the doping of transition metal ions. The photoluminescence spectra of metal doped and pristine GCN were monitored and the trend of quenching efficiency was found to be Cu 2+  > Co 2+  > Mn 2+ . Interestingly, with the increasing doping concentration of different metal ions simultaneous red shift and luminescence quenching was determined in the photoluminescence spectra as well as increased absorption tail in longer wavelength hence enhancement in the bandgap. The change in the optical properties could be mainly due to structural reconstruction and doping induced electronic redistribution is discussed., (Copyright © 2018 Elsevier B.V. All rights reserved.)

The development of high volumetric or areal capacitance energy storage devices is critical for the future electronic devices. Hence, the hunting for next-generation electrode materials and their design is of current interest. The recent work in the two-dimensional metal hydroxide nanomaterials demonstrates its ability as a promising candidate for supercapacitor due to its unique structure and additional redox sites. This study reports a design of freestanding high-mass-loaded copper-cobalt hydroxide interconnected nanosheets for high-volumetric/areal-performance electrode. The unique combination of hydroxide electrode with high mass loading (26 mg/cm 2 ) exhibits high areal and volumetric capacitance of 20.86 F/cm 2 (1032 F/cm 3 ) at a current density of 10 mA/cm 2 . This attributes to the direct growth of hydroxides on porous foam and conductivity of copper, which benefits the electron transport. The asymmetric supercapacitor device exhibits a high energy density of 21.9 mWh/cm 3 , with superior capacitance retention of 96.55% over 3500 cycles., Competing Interests: The authors declare no competing financial interest.

Background: Positron emission tomography (PET) forms an integral part in work-up and follow-up of various malignancies. With the increased use of PET in oncology, finding of an incidental focal thyroid uptake (incidentaloma) is not unusual and presents a diagnostic challenge., Aim: The aim of the following study is to evaluate the frequency and radio-pathologic correlation of focal 18-fluoro deoxyglucose uptake (FDG) on PET within the thyroid from a large series., Materials and Methods: Retrospective review of 37,000 consecutive patients who underwent FDG-PET at tertiary cancer center in India. Radiological, pathological, PET scan and follow-up details were evaluated. Statistical analyzes were carried out using Mann Whitney test and Pearson correlation., Results: Abnormal thyroid uptake was seen in 78 (0.2%) patients. Nearly 61 (0.16%) scans had focal and 17 (0.04%) had diffuse FDG uptake. A total of 57 patients with focal uptake were available for further evaluation. No further evaluation was done in 24 (42.1%) patients who had advanced index malignancy. Of the remaining 33 patients 26 were benign and seven were a cause for concern (four primary thyroid cancers, one follicular neoplasm with hurthle cell change and two metastatic cancers). There was no significant correlation in Standardized uptake value (SUV) max of benign and malignant lesion (P = 0.5 on Mann Whitney) or size (r = 0.087 Pearson correlation co-efficient P= 0.667)., Conclusion: Incidence of PET incidentaloma is low in this large cohort of Indian patients. Nearly 27% of focal incidentaloma were malignant. There was no correlation between the SUVmax, size and malignancy.

Background: The purpose of this study was to compare sentinel node biopsy (SNB) and ultrasound-guided fine-needle aspiration cytology (FNAC) for preoperative evaluation of the N0 neck in T1 to T2 oral cavity squamous cell carcinoma (SCC)., Methods: Fifty-one consecutive patients with T1 to T2 N0 oral cavity SCC were included in this study. Preoperative ultrasound was performed in all patients. Ultrasound-guided FNAC was performed in patients in whom the ultrasound result was reported as indeterminate or positive. SNB was done in all patients followed by elective neck dissection (END). Histopathology of END was considered as the gold standard for all statistical analysis., Results: The incidence of occult metastasis was 26.4%. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 71.4%, 100%, 100%, and 90.2% for SNB and 14.3%, 100%, 100%, and 76.5% for ultrasound-guided FNAC., Conclusion: Ultrasound-guided FNAC lacked sufficient accuracy to detect occult metastases. SNB is a reliable method to detect occult metastasis that has potential to replace END., (© 2014 Wiley Periodicals, Inc.)

Herein, we report the luminomagnetic bifunctional properties of two-dimensional (2D) Mn(2+) bonded graphene oxide (GO)/reduced graphene oxide (RGO) nanosheets synthesized using a facile route of oxidation followed by a solvothermal reduction method. Photoluminescence (PL) studies (excited by different wavelengths) revealed that the resonant energy transfer between Mn(2+) and sp(3)/sp(2) clusters of GO/RGO is responsible for the enhancement of emissions. Moreover, pH-sensitive PL behaviors have also been investigated in detail. The ferromagnetic behavior is believed to arise due to defects in Mn(2+) bonded GO composites. Thus, present reduction method provides a direct route to tune and enhance the optical properties of GO and RGO nanosheets bonded with Mn(2+) ions, which creates an opportunity for various technological applications.

Background: Recent studies indicate that the risk of coronary artery disease (CAD) in women is no less than that in men and menopausal women are equally vulnerable as men. Studies of recent risk factors like hyperhomocysteinemia and elevation in lipoprotein (a) reveal controversial role of the same. This study hence is an attempt to study the prevalence of these factors in women and their correlation with lipid profile., Materials and Methods: Two hundred women were enrolled in the study- 100 premenopausal women (21-45y) and 100 menopausal (50-55y). All the subjects were screened for homocysteine by ELISA and lipoprotein (a) and lipid profile by automation., Results: Prevalence of hyperhomocysteinemia was 52% and 62% in premenopausal and menopausal women respectively. A significant positive correlation was seen for total cholesterol and triacylglycerol with serum Homocysteine in premenopausal women while pronounced positive correlation for serum cholesterol with serum Homocysteine in menopausal women. The prevalence of elevated lipoprotein (a) was 42% and 45% in premenopausal and menopausal women respectively. There was no correlation between lipoprotein (a) and lipid profile in both groups., Conclusion: The findings of the study conclude that premenopausal and menopausal women constitute a subpopulation where recent risk factors like hyperhomocysteinemia and elevated lipoprotein(a) could be assessed along with lipid profile as screening tests to identify the risk of CAD. This would help in proper counselling of the concerned women and minimize the risk.

Context: Head and neck surgeries are complex. Wound complications are associated with considerable morbidity and can result in delay in the adjuvant treatment. Identification of factors will help in formulating preventive guidelines., Aims: The aim of this study is to identify perioperative factors responsible for wound complications., Settings and Design: Prospective study of 186 head and neck patients., Subjects and Methods: Pre-operative, intraoperative and post-operative factors were recorded. Each patient was evaluated for minor and major wound complications twice daily during the hospital stay., Statistical Analysis: Chi-square test was used for univariate and log regression test was used for multivariate analysis., Results: The overall wound complication rate was 29% with 7% major and 22% minor complications. On univariate analysis, laryngeal and hypopharyngeal location, advanced T stage, poor oral hygiene, clean-contaminated surgery, low Karnofsky performance status (KPS), flap reconstruction, blood loss more than 1000 ml, perioperative blood transfusion, duration of surgery greater than 4.3 h and post-operative hemoglobin lesser than 11 g%, post-operative tracheostomy and resection of mandible were statistical significant factors. On multivariate analysis, post-operative tracheostomy, low KPS, post-operative serum albumin less than 3.7 g/dl and duration of surgery greater than 4.3 h were significant factors., Conclusion: Apart from unavoidable factors, it is essential to take care of certain factors viz nutrition, haemoglobin, oral hygiene, asepsis and repeating antibiotics in prolonged surgery.

Background: Pharyngoesophageal spasm is a known entity to cause hypertonic/failed tracheoesophageal speech and is successfully treated by botulinum toxin A injection. However, success of botulinum toxin treatment is based on the accurate localization of the pharyngoesophageal segment., Methods: A 65-year-old man who had a laryngectomy using voice prosthesis with hypertonic speech underwent ultrasonographic localization of the hypertonic pharyngoesophageal segment. The ultrasound findings were confirmed using videofluoroscopy. Under ultrasound guidance, botulinum toxin was injected into the hypertonic pharyngoesophageal segment and subsequently voice outcomes were evaluated by a speech language pathologist and the pharyngoesophageal segment was assessed by using an ultrasound scan., Results: The patient had improvement in his postinjection tracheoesophageal puncture speech. Ultrasound scan assessment of the pharyngoesophageal segment showed adequate dilation as compared to the pre-botulinum toxin injection treatment., Conclusion: Ultrasonographic localization of the hypertonic pharyngoesophageal segment and ultrasound-guided botulinum toxin injection is a simple, quick, and relatively cheap method to be used in routine practice., (Copyright © 2011 Wiley Periodicals, Inc.)

An ectopic thyroid gland may be present in any location along the path of migration from the foramen caecum to the mediastinum. The most common locations for an ectopic thyroid are the lingual thyroid followed by median cervical cysts. An ectopic thyroid in the submandibular region is extremely rare. We present the case of a 44-year-old patient with ectopic thyroid tissue in submandibular space and a review of the literature related to it.

Thyroid cancers cover a large spectrum of disease with diametrically opposite prognosis. At one end of the spectrum we have the well differentiated cancers which carry an excellent prognosis, while at the other end there is anaplastic cancer with high mortality rates and dismal prognosis. Management of thyroid cancers still has some controversial issues due to lack of randomized controlled trials. Extent of surgery, extent of neck dissection, role of radioiodine treatment and thyroid stimulating hormone suppression are still debatable. In this review, we highlight these controversial issues and give guidelines for the management and follow up of patients with thyroid cancer.