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Astrup studies in the newborn

Hee Wan Jang H

Med J Malaya, 1971 Mar;25(3):208-10.
PMID: 4253248
Fulltext A framework for determining the life cycle GHG emissions of fossil marine fuels in countries reliant on imported energy through maritime transportation: A case study of South Korea

Ha S, Jeong B, Jang H, Park C, Ku B

Sci Total Environ, 2023 Nov 01;897:165366.
PMID: 37419370 DOI: 10.1016/j.scitotenv.2023.165366

This research was motivated to address limitations in the current lifecycle assessment frameworks with the absence of proper guidelines for developing default lifecycle values of energies in consideration of supply chain activities and maritime transportation. Given this, it aims to evaluate the level of life cycle GHG emissions of heavy fuel oil, LNG, LPG and methanol as marine fuels produced and supplied in energy import-dependent countries, using South Korea as a case study. The analysis clearly shows that the impact of international shipping on Well-to-Tank (WtT) GHG emissions for energy carriers would be subject to several factors: propulsion system types, the quantify of energy transported, and the routes and distances of voyages. For instance, transportation emissions from LNG carriers for LNG fuel vary significantly depending on the country of import, ranging from 2.26 g CO2 eq./MJ (representing 12.2 % of Well-to-Tank (WtT) emissions for Malaysia) to 5.97 g CO2 eq./MJ (representing 33.3 % of WtT emissions for Qatar). As a preliminary study, an enhancement on the quality of the input/inventory data is imperative for obtaining a reliability of results. Nevertheless, the comparative analysis of different fuels and life stages provides valuable insights for stakeholders to develop effective policies and energy refueling plans for reducing life cycle GHG emissions from marine fuels. These findings could also enhance the current regulatory framework and provide meaningful lifecycle carbon footprints of marine fuels for energy importing countries. The study results also strongly suggest that default values of GHG emission for different countries relying on energy imports via international maritime transport should be further developed in consideration of the impact of regional differences, such as distance, from the importing country for successful arrival of LCA application on marine industry.
Dataset on the assessment of pervious concrete containing palm oil kernel shell and seashell in heavy metal removal from stormwater

Khankhaje E, Kim T, Jang H, Kim CS, Kim J, Rafieizonooz M

Data Brief, 2023 Oct;50:109570.
PMID: 37767122 DOI: 10.1016/j.dib.2023.109570

The dataset currently available comprises data on the removal rates of heavy metals (Ba, Se, Cr, Fe, Cd, As, and Co) through the incorporation of seashells and palm oil kernel shells into pervious concrete for stormwater treatment. Stormwater runoff was collected from commercial areas in Taman University, Skudai, Johor, Malaysia. The stormwater samples underwent filtration and were preserved in high-density polyethylene (HDPE) bottles at a temperature of 4 °C for use as incoming water. The outgoing water, referred to as effluent, was obtained from tests performed on pervious concrete samples after a curing period of 28 days. The pervious concrete mixes were created with a water-to-binder ratio (w/b ratio) of 32% and a sand ratio of 10%. Three different levels of palm oil kernel shell and seashell content were used as coarse aggregate replacements: 0%, 25%, and 50%. Two single-size group were considered for both palm oil kernel shell and seashell: (6.3-9.5 mm) and (4.75-6.3 mm). Heavy metal analyses were conducted on the influent and effluent using a PerkinElmer ELAN 6100 Series Inductively Coupled Plasma- Mass Spectrometer (ICP-MS). The available datasets consist of both raw and analyzed data.
Fulltext Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases

Yoon C, Nam KC, Lee YK, Kang Y, Choi SJ, Shin HM, et al.

J Korean Med Sci, 2019 Oct 14;34(39):e255.
PMID: 31602825 DOI: 10.3346/jkms.2019.34.e255

BACKGROUND: Medical device adverse event reporting is an essential activity for mitigating device-related risks. Reporting of adverse events can be done by anyone like healthcare workers, patients, and others. However, for an individual to determine the reporting, he or she should recognize the current situation as an adverse event. The objective of this report is to share observed individual differences in the perception of a medical device adverse event, which may affect the judgment and the reporting of adverse events.
METHODS: We trained twenty-three participants from twelve Asia-Pacific Economic Cooperation (APEC) member economies about international guidelines for medical device vigilance. We developed and used six virtual cases and six questions. We divided participants into six groups and compared their opinions. We also surveyed the country's opinion to investigate the beginning point of 'patient use'. The phases of 'patient use' are divided into: 1) inspecting, 2) preparing, and 3) applying medical device.
RESULTS: As for the question on the beginning point of 'patient use,' 28.6%, 35.7%, and 35.7% of participants provided answers regarding the first, second, and third phases, respectively. In training for applying international guidelines to virtual cases, only one of the six questions reached a consensus between the two groups in all six virtual cases. For the other five questions, different judgments were given in at least two groups.
CONCLUSION: From training courses using virtual cases, we found that there was no consensus on 'patient use' point of view of medical devices. There was a significant difference in applying definitions of adverse events written in guidelines regarding the medical device associated incidents. Our results point out that international harmonization effort is needed not only to harmonize differences in regulations between countries but also to overcome diversity in perspectives existing at the site of medical device use.
Fulltext Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer: Secondary Analysis of a Randomized Clinical Trial

Pivot X, Cortés J, Lüftner D, Lyman GH, Curigliano G, Bondarenko IM, et al.

JAMA Netw Open, 2023 Apr 03;6(4):e235822.
PMID: 37022687 DOI: 10.1001/jamanetworkopen.2023.5822

IMPORTANCE: Trastuzumab has been the standard of care for the treatment of patients with ERBB2-positive breast cancer; however, cardiac events have been reported. This long-term follow-up study provides clinical evidence supporting the similarity of a trastuzumab biosimilar (SB3) to reference trastuzumab (TRZ).
OBJECTIVE: To compare cardiac safety and efficacy between SB3 and TRZ for patients with ERBB2-positive early or locally advanced breast cancer after up to 6 years of follow-up.
DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of a randomized clinical trial, conducted from April 2016 to January 2021, included patients with ERBB2-positive early or locally advanced breast cancer from a multicenter double-blind, parallel-group, equivalence phase 3 randomized clinical trial of SB3 vs TRZ with concomitant neoadjuvant chemotherapy who completed neoadjuvant and adjuvant treatment.
INTERVENTIONS: In the original trial, patients were randomized to either SB3 or TRZ with concomitant neoadjuvant chemotherapy for 8 cycles (4 cycles of docetaxel followed by 4 cycles of fluorouracil, epirubicin, and cyclophosphamide). After surgery, patients continued SB3 or TRZ monotherapy for 10 cycles of adjuvant treatment per previous treatment allocation. Following neoadjuvant and adjuvant treatment, patients were monitored for up to 5 years.
MAIN OUTCOMES AND MEASURES: The primary outcomes were the incidence of symptomatic congestive heart failure and asymptomatic, significant decrease in left ventricular ejection fraction (LVEF). The secondary outcomes were event-free survival (EFS) and overall survival (OS).
RESULTS: A total of 538 female patients were included (median age, 51 years [range, 22-65 years]). Baseline characteristics were comparable between the SB3 and TRZ groups. Cardiac safety was monitored for 367 patients (SB3, n = 186; TRZ, n = 181). Median follow-up was 68 months (range, 8.5-78.1 months). Asymptomatic, clinically significant LVEF decreases were rarely reported (SB3, 1 patient [0.4%]; TRZ, 2 [0.7%]). No patient experienced symptomatic cardiac failure or death due to a cardiovascular event. Survival was evaluated for the 367 patients in the cardiac safety cohort and an additional 171 patients enrolled after a protocol amendment (538 patients [SB3, n = 267; TRZ, n = 271]). No difference was observed in EFS or OS between treatment groups (EFS: hazard ratio [HR], 0.84; 95% CI, 0.58-1.20; P = .34; OS: HR, 0.61; 95% CI, 0.36-1.05; P = .07). Five-year EFS rates were 79.8% (95% CI, 74.8%-84.9%) in the SB3 group and 75.0% (95% CI, 69.7%-80.3%) in the TRZ group, and OS rates were 92.5% (95% CI, 89.2%-95.7%) in the SB3 group and 85.4% (95% CI, 81.0%-89.7%) in the TRZ group.
CONCLUSIONS AND RELEVANCE: In this secondary analysis of a randomized clinical trial, SB3 demonstrated cardiac safety and survival comparable to those of TRZ after up to 6 years of follow-up in patients with ERBB2-positive early or locally advanced breast cancer.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02771795.
Fulltext Cognitive trajectories of patients with focal ß-amyloid deposition

Kim SE, Lee B, Jang H, Chin J, Khoo CS, Choe YS, et al.

Alzheimers Res Ther, 2021 02 19;13(1):48.
PMID: 33608041 DOI: 10.1186/s13195-021-00787-7

BACKGROUND: The presence of ß-amyloid (Aß) in the brain can be identified using amyloid PET. In clinical practice, the amyloid PET is interpreted based on dichotomous visual rating, which renders focal Aß accumulation be read as positive for Aß. However, the prognosis of patients with focal Aß deposition is not well established. Thus, we investigated cognitive trajectories of patients with focal Aß deposition.
METHODS: We followed up 240 participants (112 cognitively unimpaired [CU], 78 amnestic mild cognitive impairment [aMCI], and 50 Alzheimer's disease (AD) dementia [ADD]) for 2 years from 9 referral centers in South Korea. Participants were assessed with neuropsychological tests and 18F-flutemetamol (FMM) positron emission tomography (PET). Ten regions (frontal, precuneus/posterior cingulate (PPC), lateral temporal, parietal, and striatum of each hemisphere) were visually examined in the FMM scan, and participants were divided into three groups: No-FMM, Focal-FMM (FMM uptake in 1-9 regions), and Diffuse-FMM. We used mixed-effects model to investigate the speed of cognitive decline in the Focal-FMM group according to the cognitive level, extent, and location of Aß involvement, in comparison with the No- or Diffuse-FMM group.
RESULTS: Forty-five of 240 (18.8%) individuals were categorized as Focal-FMM. The rate of cognitive decline in the Focal-FMM group was faster than the No-FMM group (especially in the CU and aMCI stage) and slower than the Diffuse-FMM group (in particular in the CU stage). Within the Focal-FMM group, participants with FMM uptake to a larger extent (7-9 regions) showed faster cognitive decline compared to those with uptake to a smaller extent (1-3 or 4-6 regions). The Focal-FMM group was found to have faster cognitive decline in comparison with the No-FMM when there was uptake in the PPC, striatum, and frontal cortex.
CONCLUSIONS: When predicting cognitive decline of patients with focal Aß deposition, the patients' cognitive level, extent, and location of the focal involvement are important.
WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 25-26 June 2019

Wadhwa M, Kang HN, Jivapaisarnpong T, WHO implementation workshop on guidelines on procedures and data requirements for changes to approved biotherapeutic products, Andalucia LR, Blades CDRZ, et al.

Biologicals, 2020 May;65:50-59.
PMID: 31959504 DOI: 10.1016/j.biologicals.2019.12.008

The first global workshop on implementation of the WHO guidelines on procedures and data requirements for changes to approved biotherapeutic products adopted by the WHO Expert Committee in 2018 was held in June 2019. The workshop participants recognized that the principles based on sound science and the potential for risk, as described in the WHO Guidelines on post-approval changes, which constitute the global standard for product life-cycle management are providing clarity and helping national regulatory authorities in establishing guidance while improving time-lines for an efficient regulation of products. Consequently, the regulatory situation for post-approval changes and guideline implementation is changing but there is a disparity between different countries. While the guidelines are gradually being implemented in some countries and also being considered in other countries, the need for regional workshops and further training on post-approval changes was a common theme reiterated by many participants. Given the complexities relating to post-approval changes in different regions/countries, there was a clear understanding among all participants that an efficient approach for product life-cycle management at a national level is needed to ensure faster availability of high standard, safe and efficacious medicines to patients as per the World Health Assembly Resolution 67.21.