Remote-controlled cholangiography injection device: first clinical study in China

Background X-ray cholangiography is of great value in the imaging of biliary tract diseases; however, occupational radiation exposure is unavoidable. Moreover, clinicians must manually inject the contrast dye, which may result in a relatively high incidence of adverse reactions due to unstable injection pressure. Thus, there is a need to develop a novel remote-controlled cholangiography injection device. Methods Patients with external biliary drainage requiring cholangiography were included. A remote-controlled injection device was developed with three major components: an injection pump, a pressure sensor, and a wireless remote-control panel. Image quality, adverse reactions, and radiation dose were evaluated. Results Different kinds of X-ray cholangiography were successfully and smoothly performed using this remote-controlled injection device in all patients. The incidence of adverse reactions in the device group was significantly lower than that in the manual group (4.17% vs. 13.9%, P = 0.001), and increasing the injection pressure increased the incidence of adverse reactions. In addition, the device helped operators avoid ionizing radiation completely. Conclusions With good control of injection pressure (within 10 kPa), the remote-controlled cholangiography injection device could replace the need for the doctor to inject contrast agent with good security and effectivity. It is expected to be submitted for clinical application.

Development of a spin-injection device utilising Gadolinium Nitride

<p>In this thesis, the first steps in creating a realisable spin-injection transistor using ferromagnetic semiconductor electrodes are detailed. A spin-injection device utilising the ferromagnetic semiconductor gadolinium nitride has been designed, fabricated and electrically tested. In addition, an experimental setup for future measurements of a spin current in spin-injection devices was adapted to our laboratory-based off one developed by the Shiraishi group at Kyoto University. Issues encountered during fabrication were identified, and an optimal method for fabricating these devices was determined. Gadolinium nitride and copper were used to make the devices on Si/SiO2 substrates. The electrical integrity and applicability of the devices for future measurements of injected spin-current was determined through electrical device testing. Resistance measurements of electrical pathways within the device were undertaken to determine the successful deposition of the gadolinium nitride and copper. IV measurements to determine if the devices could withstand the current required for spin current measurements were done. The durability of the devices through multiple measurement types was observed. It was determined that although spin-injection devices utilising gadolinium nitride can be successfully fabricated, more work needs to be done to ensure that the electrical pathways through the copper and gadolinium nitride can be consistently reproducible to allow spin-injection measurements to be done.</p>

Development of a spin-injection device utilising Gadolinium Nitride

<p>In this thesis, the first steps in creating a realisable spin-injection transistor using ferromagnetic semiconductor electrodes are detailed. A spin-injection device utilising the ferromagnetic semiconductor gadolinium nitride has been designed, fabricated and electrically tested. In addition, an experimental setup for future measurements of a spin current in spin-injection devices was adapted to our laboratory-based off one developed by the Shiraishi group at Kyoto University. Issues encountered during fabrication were identified, and an optimal method for fabricating these devices was determined. Gadolinium nitride and copper were used to make the devices on Si/SiO2 substrates. The electrical integrity and applicability of the devices for future measurements of injected spin-current was determined through electrical device testing. Resistance measurements of electrical pathways within the device were undertaken to determine the successful deposition of the gadolinium nitride and copper. IV measurements to determine if the devices could withstand the current required for spin current measurements were done. The durability of the devices through multiple measurement types was observed. It was determined that although spin-injection devices utilising gadolinium nitride can be successfully fabricated, more work needs to be done to ensure that the electrical pathways through the copper and gadolinium nitride can be consistently reproducible to allow spin-injection measurements to be done.</p>

Connected health for growth hormone treatment research and clinical practice: learnings from different sources of real-world evidence (RWE)—large electronically collected datasets, surveillance studies and individual patients’ cases

Background A range of factors can reduce the effectiveness of treatment prescribed for the long-term management of chronic health conditions, such as growth disorders. In particular, prescription medications may not achieve the positive outcomes expected because approximately half of patients adhere poorly to the prescribed treatment regimen. Methods Adherence to treatment has previously been assessed using relatively unreliable subjective methods, such as patient self-reporting during clinical follow-up, or counting prescriptions filled or vials returned by patients. Here, we report on a new approach, the use of electronically recorded objective evidence of date, time, and dose taken which was obtained through a comprehensive eHealth ecosystem, based around the easypod™ electromechanical auto-injection device and web-based connect software. The benefits of this eHealth approach are also illustrated here by two case studies, selected from the Finnish cohort of the easypod™ Connect Observational Study (ECOS), a 5-year, open-label, observational study that enrolled children from 24 countries who were being treated with growth hormone (GH) via the auto-injection device. Results Analyses of data from 9314 records from the easypod™ connect database showed that, at each time point studied, a significantly greater proportion of female patients had high adherence (≥ 85%) than male patients (2849/3867 [74%] vs 3879/5447 [71%]; P < 0.001). Furthermore, more of the younger patients (< 10 years for girls, < 12 years for boys) were in the high adherence range (P < 0.001). However, recursive partitioning of data from ECOS identified subgroups with lower adherence to GH treatment ‒ children who performed the majority of injections themselves at an early age (~ 8 years) and teenagers starting treatment aged ≥ 14 years. Conclusions The data and case studies presented herein illustrate the importance of adherence to GH therapy and how good growth outcomes can be achieved by following treatment as described. They also show how the device, software, and database ecosystem can complement normal clinical follow-up by providing HCPs with reliable information about patient adherence between visits and also providing researchers with real-world evidence of adherence and growth outcomes across a large population of patients with growth disorders treated with GH via the easypod™ device.

Positive Impact of Targeted Educational Intervention in Children With Low Adherence to Growth Hormone Treatment Identified by Use of the Easypod™ Electronic Auto-injector Device

Background: It is important to identify patients with low adherence to recombinant human growth hormone (r-hGH) therapy and initiate actions to improve adherence. The Merck Patient Support Program (PSP) aims to raise the awareness of these patients and their parents of the importance of good adherence in achieving optimal growth outcomes. The easypod™ digitally-enhanced injection device provides accurate, reliable adherence data for the PSP by recording the exact dose, time and date of injections given. In this study, we aimed to measure the effect of an educational intervention on adherence in patients using the easypod™ device to deliver their r-GH therapy.Methods: This was a 12-month observational, retrospective cohort study. Patients previously identified by data recorded from their easypod™ injection device as having low adherence (&lt;80%) were followed over the 6 months before and after a targeted educational visit by a PSP nurse. Patient adherence and demographic data were extracted from the PSP database. Statistical analyzes were carried out with STATA 15.0 software.Results: Data from 80 patients (65% male) with low adherence were analyzed. Patients were aged 2–18 (mean: 11.77) years with diagnoses of growth hormone deficiency (71.25%), small for gestational age (20%), Turner syndrome (7.50%) and chronic renal disease (1.25%). Duration of treatment was 0.40–11.13 (median: 3.62) years. At baseline, median adherence to r-hGH therapy was 67%; after the intervention it increased to 76%, a statistically significant median improvement of 9% (p = 0.0000, Wilcoxon signed-rank test). Additionally, 36% (29/80) of patients increased their adherence to r-hGH therapy to ‘good’ (≥80%). Both changes were clinically relevant.Conclusions: We conclude that a nurse-led educational intervention, supported by digital medication adherence monitoring, is a simple method to improve adherence to r-hGH therapy, and recommend this intervention to reduce the gap between the indication/recommendation of the specialist and patients' behavior.

Use of an automatic needle-free injection device for foot-and-mouth disease vaccination in dairy heifers

The foot-and-mouth disease (FMD) vaccination of Thai dairy cows is routinely conducted to control and prevent the disease. In Thailand, FMD control strategies include a subcutaneous route (s.c.) vaccination with 2 ml of inactivated FMD vaccine 2–3 times a year produced by the Department of Livestock Development (DLD). A new way of vaccination was introduced in the form of an automatic needle-free injection device. This technology has several important advantages, such as requiring less animal restraint, reduced time and labour with high precision, and a consistent delivery system. Here, the effectiveness of an automatic needle-free injection (ANFI) device was evaluated in 30 dairy heifers (randomly divided into three groups, 10 in each group) in the FMD vaccine delivery. The first group was subcutaneously (s.c.) vaccinated using a conventional hypodermic needle with 2 ml of the vaccine, the second group received the same, but using a CO₂-powered ANFI device, and the third group received the vaccine using the same ANFI device, but administered intradermally (i.d.) with only 1 ml of the vaccine. The blood samples collected up to 120 days post-vaccination revealed that both injection methods resulted in a similar serological response. The results suggest that the i.d. and s.c. ANFI systems are effective and safe. Moreover, the i.d. use of the ANFI enabled the possibility to half the vaccination dose with the same efficacy. Therefore, the ANFI can be used as an alternative approach for FMD vaccination by s.c. or i.d. routes in dairy cows in Thailand. Ultimately, reducing the use of restraint devices and labour will improve the vaccination for the prevention and control of FMD and may improve the cows’ welfare.