Folic Acid, Vitamin B6, B12 Co-supplementation Effect on Inflammatory Status of Diabetic Neuropathy Patients

Background: Diabetic neuropathy is common in diabetes mellitus patients with the prevalence of 50%. Inflammation takes a vital role in the complex pathogenesis of diabetic neuropathy. The decreased inflammation status is becoming a potential target of therapy and prevention of diabetes complication. Objective: to investigate the supplementation effect of vitamin B6, folic acid, and vitamin B12 in combination to inflammatory status of diabetic neuropathy patients. Method: experimental design with randomized controlled trial. Subject of study diabetic neuropathy patients. Place of study Tugurejo Hospital, Semarang in September 2018 to March 2019, with sample size of 75 subjects (treatment and control group). Results: Subjects of the study consists of 56 females and 19 males. The characteristic of subject in treatment and control group is not significantly different based on sex, vitamin B6, folic acid, vitamin B12 intake, and nutritional status. Compared with placebo, the effect of vitamin B6, folic acid, vitamin B12 co-supplementation is able to decrease serum Hs-CRP significantly with mean difference of -3.0 (CI 95% -4,95, -1,08; p <0,05. Conclusion: Co-supplementation of vitamin B6, folic acid, vitamin B12 is able to significantly decrease inflamation status. Keyword: Folic acid, vitamin B6, vitamin B12, inflammation status, diabetic neuropathy

Głos w dyskusji o zaniechaniu ścigania jako sposobie reakcji na przestępstwo w prawnie dopuszczalnym procesie karnym

The subject of considerations is an attempt to describe and assess the institution of cessation of prosecution, resulting from reaching an agreement, as reaction to crime. The effective consensus-driven approach ought to be aimed at combining court instruments and values with the axiological basis of agreement-based litigation (namely, principle of restorative justice), and also with legal measures which allow to mete out a due penal reaction or, frequently, the cessation of prosecution. In case of proceedings regarding misdemeanours, where there is a possibility of eliminating the consequences of the crime solely by compensatory actions within victim-perpetrator relation, the state ought to waive the execution of ius puniendi. What should constitute the limit of waiving the right to punish is a combination of circumstances such as: negligible degree of social harm, reaching a plea agreement that includes the manner of compensation, along with executing thereof. Then, the sufficient reaction to crime is redressing damage or compensation for the harm suffered and the prosecutor’s decision to cease prosecution. The stage of judicial proceeding does not have to and should not be merely a forum for reaching and executing court agreements. The described variant of cessation of the prosecution combines instrumental values, such as the promptness and cost-effectiveness of proceedings with non-instrumental ones, such as due process and implementation of restorative justice. Through only partial waiver of the trial subject implementation, cessation of the proceedings may constitute a compromise between legalistic values and those of judicial opportunism.

Drug-drug interactions in subjects enrolled in SWOG trials of oral chemotherapy

Background Patients with cancer are at increased risk of drug-drug interactions (DDI), which can increase treatment toxicity or decrease efficacy. It is especially important to thoroughly screen DDI in oncology clinical trial subjects to ensure trial subject safety and data accuracy. This study determined the prevalence of potential DDI involving oral anti-cancer trial agents in subjects enrolled in two SWOG clinical trials. Methods Completed SWOG clinical trials of commercially available agents with possible DDI that had complete concomitant medication information available at enrollment were included. Screening for DDI was conducted through three methods: protocol-guided screening, Lexicomp® screening, and pharmacist determination of clinical relevance. Descriptive statistics were calculated. Results SWOG trials S0711 (dasatinib, n = 83) and S0528 (everolimus/lapatinib, n = 84) were included. Subjects received an average of 6.6 medications (standard deviation = 4.9, range 0–29) at enrollment. Based on the clinical trial protocols, at enrollment 18.6% (31/167) of subjects had a DDI and 12.0% (20/167) had a DDI that violated a protocol exclusion criterion. According to Lexicomp®, 28.7% of subjects (48/167) had a DDI classified as moderate or worse, whereas pharmacist review indicated that 7.2% of subjects (12/167) had a clinically relevant interaction. The majority of clinically relevant DDI identified were due to the coadministration of acid suppression therapies with dasatinib (83.3%, 10/12). Conclusions The high DDI prevalence in subjects enrolled on SWOG clinical trials, including a high prevalence that violate trial exclusion criteria, support the need for improved processes for DDI screening to ensure trial subject safety and trial data accuracy.

Pengembangan Pembelajaran Kebugaran Jasmani Unsur Kelincahan Berbasis Multimedia Interaktif

This development research aims to develop learning of physical fitness agility elements based on interactive multimedia in SMP Negeri 4 Malang. Using the Research and Development (R&D) model with Lee & Owen. Using a small group trial subject of 20 students and a large group trial subject of 60 students consisting of class VII and class VIII. Based on the results of data analysis obtained from learning experts with a percentage of 93%, physical fitness experts with a percentage of 91%, media experts with a percentage of 90%, small group trials 89%, and large group trials 89%. Based on the analysis of the data that has been obtained, it is concluded that the development product is suitable for use in the learning process. Abstrak: Penelitian pengembangan ini bertujuan mengembangkan pembelajaran kebugaran jasmani unsur kelincahan berbasis multimedia interaktif di SMP Negeri 4 Malang. Menggunakan model Reseach and Development (R&D) dengan Lee & Owen. Menggunakan subjek uji coba kelompok kecil 20 siswa dan subjek uji coba kelompok besar 60 siswa terdiri dari kelas VII dan kelas VIII. Berdasarkan hasil analisis data yang diperoleh dari ahli pembelajaran dengan persentase 93%, ahli kebugaran jasmani dengan persentase 91%, ahli media dengan persentase 90%, uji coba kelompok kecil 89%, dan uji coba kelompok besar 89%. Berdasarkan analisis data yang telah diperoleh, disimpulkan bahwa produk pengembangan layak digunakan dalam proses pembelajaran.

The general data protection regulation, the clinical trial regulation and some complex interplay in paediatric clinical trials

Although a number of authors have commented upon the impact of the GDPR on clinical trial conduct, few have examined the specific setting of paediatric trials. Whilst the general principles are the same as those for adults, some additional considerations arise. The ages of consent relating to data privacy and clinical trial participation are different in a number of countries, but the distinction is often not recognised in non-drug trials. Accidental pregnancies in clinical trials always raise complexities, but these are amplified when the trial subject is a minor, and the processes described in clinical trial protocols rarely take account of GDPR requirements. This paper describes approaches which can be taken to ensure the rights of children are respected.Conclusion: The conduct of paediatric clinical trials within GDPR requirements is quite possible provided authors think carefully when drafting protocols. What is Known:•GDPR is applicable to clinical trials, including paediatric trials.•A number of challenges at the interface between the GDPR and CTR have been described. What is New:•The application of the GDPR to certain specific situations in paediatric trials does not appear to have been explored.•Three such situations are described and solutions offered.

Building a specialized lexicon for breast cancer clinical trial subject eligibility analysis

A natural language processing (NLP) application requires sophisticated lexical resources to support its processing goals. Different solutions, such as dictionary lookup and MetaMap, have been proposed in the healthcare informatics literature to identify disease terms with more than one word (multi-gram disease named entities). Although a lot of work has been done in the identification of protein- and gene-named entities in the biomedical field, not much research has been done on the recognition and resolution of terminologies in the clinical trial subject eligibility analysis. In this study, we develop a specialized lexicon for improving NLP and text mining analysis in the breast cancer domain, and evaluate it by comparing it with the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT). We use a hybrid methodology, which combines the knowledge of domain experts, terms from multiple online dictionaries, and the mining of text from sample clinical trials. Use of our methodology introduces 4243 unique lexicon items, which increase bigram entity match by 38.6% and trigram entity match by 41%. Our lexicon, which adds a significant number of new terms, is very useful for matching patients to clinical trials automatically based on eligibility matching. Beyond clinical trial matching, the specialized lexicon developed in this study could serve as a foundation for future healthcare text mining applications.

Pop Up Book Kubus dan Balok Untuk Siswa SMP

The research aims to construct learning media for pop up books on cube and block materials that are suitable for use in junior high school students. This research is a development study using a modified 4-D model that is Define, Design, Develop and Deseminate from Thiagarajan. The subject of the material developed in this study was cube and beam class VIII material with a class VIII trial subject of SMPN 1 Sumbang. The results showed that the learning media pop up book was very valid (3.57) according to the validator, the teacher's response was very good (3.31) and student responses were good (3.29)