Ease of Use, Preference, and Safety of the Recombinant Human Growth Hormone Disposable Pen Compared with the Reusable Device: A Multicenter, Single-Arm, Open-Label, Switch-Over, Prospective, Phase IV Trial

PURPOSE: To assess the usability and safety of the disposable pen compared to those of reusable devices in patients receiving recombinant human growth hormone (rhGH) treatment. PATIENTS AND METHODS: This study was a multicenter, single-arm, open-label, switch-over, prospective, Phase IV trial. After screening, eligible patients who were previously treated with rhGH using a reusable device were enrolled to receive treatment with the disposable pen for 8 weeks. The ease of use, preference, and tolerability of the disposable pen compared to those of the reusable device were assessed by the subjects and/or their caregivers using a questionnaire. Adverse events were evaluated by the investigators. RESULTS: Of 116 subjects enrolled in this study, 115 received treatment with the disposable pen and 109 completed the study. The mean age of the subjects was 9.4 years. Compared to the previous reusable device, the disposable pen was assessed as significantly easier to use (mean value 7.88, 95% confidence interval (CI) [7.45-8.30] on a numerical scale ranging from 0 (far less easy) to 10 (far easier)). Furthermore, the percentage of subjects who preferred the disposable pen to the previously used reusable device was 75.7% (95% CI [67.6%-83.8%]). The percentages of subjects who rated pain and discomfort at the injection site as "not at all" were higher after using the disposable pen compared to the reusable device. No specific safety concerns were identified. CONCLUSION: The disposable pen is easier to use than the reusable devices and is preferred by approximately 75% of patients receiving rhGH treatment. Moreover, the disposable pen is safe and acceptable. Therefore, it could be a good alternative to reusable devices. The disposable pen is expected to provide benefits to patients receiving rhGH treatment. CLINICALTRIALSGOV IDENTIFIER: NCT03015909

Height outcomes in Korean children with idiopathic short stature receiving growth hormone treatment

OBJECTIVES: Growth hormone (GH) therapy's capacity to increase height velocity and height at the end of the study in children with idiopathic short stature (ISS) is controversial. We aimed to investigate the height standard deviation score (SDS) and height velocity of patients with ISS in Korea who received GH treatment. METHODS: We retrospectively reviewed and performed linear mixed model and survival analyses on data from 12 tertiary hospitals in Korea, including subjects diagnosed with ISS from January 2009 to September 2019, treated with GH therapy for more than 6 months, and who were at a pre-pubertal state at the time of diagnosis. RESULTS: We included 578 children (330 boys and 248 girls). The mean daily dose of GH in this study was 0.051 mg/kg, which was lower than the approved dose in Korea of 0.062 - 0.067 mg/kg. Height SDS was higher in patients who started treatment before the age of 6 years. The probability of reaching the target SDS (-1 SDS) from the beginning of treatment to 2-3 years after its start was higher in children starting treatment before the age of 6 years. The hazard ratio to reach the target SDS (-1 SDS) when using automatic pen or electronic devices was 1.727 times higher than that when using the needle and syringe device. CONCLUSION: ISS patients should start GH treatment at an early age, and even lower-than-recommended drug doses may be effective. The selection of automatic pen or electronic device can have a positive effect on reaching the target height SDS

Significant release of shear energy of the North Korean nuclear test on February 12, 2013

On February 12, 2013 the Democratic People\u27s Republic of Korea (DPRK) carried out an announced nuclear test, which was the third after tests conducted in 2006 and 2009. An important task in discriminating a man-made explosion and a natural tectonic earthquake is the analysis of seismic waveforms. To determine the isotropic and non-isotropic characteristics of the detonation source, I invert long-period seismic data for the full seismic moment tensor to match the observed seismic signals by synthetic waveforms based on a 3D earth model. Here, I show that the inversion of long-period seismic data of the 2013 test reveals a clear explosive (isotropic) component combined with a significant release of shear energy by the double-couple part of the moment tensor. While the isotropic part of the nuclear test in 2009 was similar to that in 2013, the double-couple part was lower by a factor of 0.55 compared to the explosion in 2013. Moreover, the ratio of the isotropic seismic moments of the 2013 and 2009 nuclear tests is 1.4±0.1 and lower than published estimations of the yield ratio, which indicates the importance of considering the release of shear energy. The determined orientation of the double-couple fault plane is parallel to the dominating geologic fault structures NNE-SSW to NE-SW, but the calculated normal faulting mechanism does not correspond to the general tectonic strike-slip regime. Thus, explanations for the enhanced release of shear energy might be induced dip-slip motion pre-stressed by the previous test or near source damaging effects due to a changed containment of the nuclear explosion

Uncompensated spins in trilayer CoFe/IrMn/NiFe exchange bias: soft x-ray resonant magnetic scattering study

We investigated an uncompensated (UC) layer in a magnetic trilayer CoFe/IrMn/NiFe using soft x- ray resonant magnetic reflectivity. Under a carefully controlled magnetic field, we resolved two UC spins in the single antiferromagnetic (AFM) layer. We found that the unpinned spins formed at both sides within the 50 angstrom thick IrMn AFM layer: t(UC1) = 17.8 angstrom for CoFe/IrMn((1)) and t(UC2) = 6.4 angstrom for IrMn((2))/NiFe. Moreover, we noted their different blocking temperatures, namely T(B) = 500 K at the UC1 layer and 470 K at the UC2 layer. There might be no noticeable magnetic interaction of the pinned spins of the two separated UC layers. Our results verify the distinct spatial separation of the two UC layers, despite the limited thickness of the single AFM layer.X1132sciescopu

Pandemic influenza A vaccination and incidence of Guillain-Barré syndrome in Korea.

BACKGROUND: Many studies have investigated the association between Guillain-Barré syndrome (GBS) and vaccinations during the influenza A H1N1 pandemic of 2009 (pH1N1). Based on a nationally representative sample, we estimated the incidence of GBS during the pandemic period in Korea. MATERIALS AND METHODS: All medical records of GBS cases were reviewed in 28 randomly selected hospitals during 2008-2010, and the number of GBS cases at the national level was extrapolated using emergency care utilization data. The GBS rate per 100,000 person-years was estimated in the reference and pandemic periods. RESULTS: The incidence of GBS was 0.63 (95% CI: 0.37-0.89) per 100,000 person-years in the reference period and 0.87 (0.49-1.26) in the pandemic period. During the vaccination season, the pandemic period GBS incidence rate was not significantly higher than the reference period incidence rate (rate ratio: 1.52; 0.99-2.32), but difference was observed among persons aged 20-34 years. Rate of GBS increased after pH1N1 vaccination compared to the reference period (1.46, 1.26-1.68). DISCUSSION: The incidence of GBS increased slightly but not significantly during the pandemic period, although pH1N1 vaccination increased the GBS rate. Therefore, mass influenza vaccination programs should not be precluded on the basis of GBS

Magnetic oxide formation at Al2O3/Co84Fe16 interface in magnetic tunnel junction

We investigated the interfacial status of ferromagnetic Co84Fe16/insulating barrier Al2O3 of the Al2O3-based magnetic tunnel junction (MTJ) using various x-ray scattering measurements. The results show formation of orthorhombic AlFeO3 magnetic nanoparticles at the interface, which are embedded in the Al2O3 cage. Their thickness and planner size vary with the plasma oxidation time. We also observed an interesting magnetic anomaly with a minimum magnetic coercivity near the AlFeO3 ferrimagnetic T-C, which is successfully explained in terms of the AlFeO3 nanoparticles and nanoscale CoFe grains with size distribution.X1122sciescopu

Kondo effect in magnetic tunnel junctions

Tunneling magnetoresistance was found to be suppressed with decreasing temperature for magnetic tunnel junctions (MTJs) oxidized under high plasma power. A strong temperature dependence of the junction resistance was observed, along with zero-bias anomalies of dynamic resistance at low temperatures. Resistance shows a logarithmic dependence on temperature, and resistance versus temperature exhibits a scaling behavior. Our experimental data can be explained in a consistent way by the Kondo effect in the MTJs with the Kondo temperature T-K=20-30 K.open1119sciescopu

Surface modification with fibrin/hyaluronic acid hydrogel on solid-free form-based scaffolds followed by BMP-2 loading to enhance bone regeneration

Bone tissue engineering often requires a well-defined scaffold that is highly porous. The multi-head deposition system (MHDS), a form of solid freeform fabrication, has raised great interest as a method for fabricating scaffolds, since it yields a highly porous inter-connective structure without the use of cytotoxic solvents, and permits the diffusion of nutrients and oxygen. However, this method is not suitable for introducing proteins, as it includes a heating process. Hydrogels incorporated with protein coating of the scaffold surface could overcome this MHDS limitation. In the present study, the surface of a scaffold fabricated using MHDS was coated with a mixture of fibrin and hyaluronic acid (HA) and used as a vehicle for delivery of both bone morphogenetic protein-2 (BMP-2) and adipose-derived stromal cells (ASCs). Fibrin/HA coating of the scaffold significantly enhanced initial cell attachment. Furthermore, the in vitro release of BMP-2 from fibrin/HA-coated scaffolds was sustained for 3 days and it stimulated the alkaline phosphatase activity of ASCs seeded on the scaffold for 10 days more actively and continuously than did the soluble BMP-2 that was added to the culture media, not the scaffold itself. Importantly, the transplantation of undifferentiated ASCs inoculated on BMP-2-loaded, fibrin/HA-coated scaffolds resulted in more improved bone formation and mineralization than did the transplantation of undifferentiated ASCs seeded on uncoated scaffolds or on fibrin/HA-coated scaffolds without BMP-2, but containing BMP-2 in the cell suspension medium. These results show that BMP-2-loaded, fibrin/HA-coated scaffolds fabricated using MHDS may be useful in stimulating bone regeneration from undifferentiated ASCs in vivo. (C) 2010 Elsevier Inc. All rights reserved.X117671sciescopu

X-ray photoelectron spectroscopy study of magnetic tunnel junctions

Magnetic tunnel junction ( MTJ) structures were investigated by x-ray photoelectron spectroscopy. The Al layer was overoxidized and the samples were treated by rapid thermal annealing. It was found that the Mn atoms in the exchange-bias layer diffused into the magnetic layer, but did not reach the oxide barrier. Although slightly higher oxygen concentration was observed at the interface between the magnetic layer and the oxide barrier, strong evidence of the oxidized magnetic-layer interface was not found. Our result is consistent with the high tunneling magnetoresistance of MTJs at room temperature. (C) 2005 American Institute of Physics.open1132sciescopu